A SYSTEM FOR LAPAROSCOPIC ULTRASOUND GUIDANCE OF A
SURGICAL CRYO-PROBE
FIELD OF THE INVENTION
The present invention relates to the field of surgical devices in general
and to the field of laparoscopy assisted cryogenic surgical systems in particular.
BACKGROUND OF THE INVENTION
The use of laparoscopy for visualizing or imaging of internal organs
within a body is well known in the art and is used for diagnostic purposes, for
performing minor surgery and for obtaining tissue samples for biopsy or other
medical purposes. A laparoscopy probe is inserted into a body cavity such as the
abdomen through an opening made in the abdominal wall and the probe is
manually guided to provide an image of internal organs. The image may be
provided by an optical system such as a fiber-optic system with or without a video
imaging system. The laparoscopy probe may also include grasping or cutting for
performing surgery.
Laparoscopy systems which use optical visualizing or imaging methods
are limited in that they can only provide an image of the external part of the
viewed organs. In cases where additional information is needed such as the
location of an internal tumor or other internal abnormal tissue which is embedded
within an organ, different methods have to be used. The abdomen is opened
using conventional non-laparoscopy surgical methods. An externally placed
ultrasound probe is used to obtain an ultrasound image of the organ and to
visualize the internal tumor. A cryo-probe can then be inserted into the abdomen
under direct visual control. The cryo-probe is inserted into the organ and
advanced until its tip penetrates the tumor by observing the positions of the
cryo-probe and the tumor on the ultrasound image. The cryogenic tip is then
cooled to selectively freeze the tumor without excessive damage to the
surrounding tissue. However, since the ultrasound image obtained by an external
ultrasound probe does not provide three-dimensional information about the
position of the cryo-probe relative to the tumor, the surgeon may have difficulties
in directing the cryo-probe to the tumor and in accurately positioning the tip of the
cryo-probe in the optimal position within the tumor.
Moreover, the ultrasound probe may need to be manipulated into
different positions relative to the cryo-probe to assist the surgeon in determining
the position of the cryo-probe relative to the tumor. This increases the complexity,
difficulty and duration of the operation since the surgeon may have to manipulate
the cryo-probe with one hand and the ultrasound probe with the other hand while
observing the ultrasound image on the ultrasound device display.
Additionally, the size of the incision made in the abdominal wall for such
open surgery increases the chance of post operative infection, requires time
consuming suturing of the incision and increases the post operative
hospitalization period.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide a system
for performing ultrasound laparoscopy cryo-surgery.
An aspect of the present invention is that the approaching and
penetration of the target tissue by the cryo-probe is assisted by the intersection of
the image of the target with the image of a line which represents the predicted
path of the cryo-probe on the ultrasound image.
Another aspect of the present invention is that the cryo-probe is inserted
into a suitable guide channel in the laparoscopy probe such that the cryo-probe is
placed in the image plane of the ultrasound scanner as it's tip approaches the
target tissue
There is thus provided, in accordance with a preferred embodiment of
the present invention, a system for performing ultrasound laparoscopic
cryo-surgery. The system includes an ultrasound laparoscopy system including a
laparoscopy ultrasound probe for providing an ultrasound image, a control unit
connected to the laparoscopy probe and a display connected to the control unit
for displaying an ultrasound image. The system also includes a cryo-probe
system including a cooling device and a cryo-probe attached to the cooling
device. The cryo-probe is insertable into a guide channel within the laparoscopy
probe and is movable therealong for penetrating and freezing a target tissue.
Further, in accordance with another preferred embodiment of the
present invention, the control unit further includes means for calculating and for
displaying a line on the display. The line represents the predicted path line of the
cryo-probe as it is moved towards the target tissue.
Further still, in accordance with yet another preferred embodiment of
the present invention, The laparoscopy probe includes a handle for manipulating
the laparoscopy probe. The laparoscopy probe further includes an elongated
scanner probe attached to the handle and having an ultrasound scanner attached
to one end thereof. The laparoscopy probe also includes a guide sleeve attached
to the handle. The guide sleeve includes a guide channel and a scanner channel
therewithin for receiving the cryo-probe and the scanner probe, respectively.
Furthermore, in accordance with another preferred embodiment of the
present invention, the cryo-probe is inserted within the guide channel for ensuring
that the tip of the cryo-probe is placed in the image plane of the ultrasound
scanner as the tip of the cryo-probe approaches the target tissue and for
visualizing the path of the tip of the cryo-probe in the ultrasound image as the tip
approaches and penetrates the target tissue.
Furthermore, in accordance with another preferred embodiment of the
present invention, the guide channel includes a hollow conduit passing within the
guide sleeve. The guide channel has two openings, a first opening, distal from the
ultrasound scanner, and a second opening, proximal to the ultrasound scanner.
The cryo-probe is inserted into the first opening, advanced within the guide
channel and emerges from the second opening to approach and penetrate the
target tissue during the ultrasound laparoscopy cryo-surgery.
Furthermore, in accordance with another preferred embodiment of the
present invention, the guide channel includes a groove formed in the guide
sleeve. The guide channel has two ends, a first end, distal from the ultrasound
scanner, and a second end, proximal to the ultrasound scanner. The cryo-probe
is inserted into the first end, advanced along the guide channel and emerges from
the second end to approach and penetrate the target tissue during the ultrasound
laparoscopy cryo-surgery.
Furthermore, in accordance with another preferred embodiment of the
present invention, the guide channel further includes at least one retainer
attached to the laparoscopy probe for retaining the cryo-probe within the groove
as the cryo-probe is advanced therealong.
Furthermore, in accordance with another preferred embodiment of the
present invention, the laparoscopy probe is moved during the ultrasound
laparoscopy cryo-surgery so as to place the image of the target tissue on the path
line.
Furthermore, in accordance with another preferred embodiment of the
present invention, the freezing of the target tissue by the cryo-probe is monitored
on the ultrasound image displayed by the display.
There is also provided, in accordance with a preferred embodiment of
the present invention, An ultrasound laparoscopy probe connectable to a system
for performing ultrasound laparoscopic cryo-surgery. The laparoscopy probe
includes a handle for manipulating the laparoscopy probe. The laparoscopy probe
further includes an elongated scanner probe attached to the handle and having
an ultrasound scanner attached to one end thereof. The laparoscopy probe also
includes a guide sleeve attached to the handle. The guide sleeve includes a guide
channel and a scanner channel therewithin for receiving the cryo-probe and the
scanner probe, respectively.
Furthermore, in accordance with another preferred embodiment of the
present invention, the guide channel includes a conduit enclosed within the guide
sleeve. The conduit has two openings, a first opening, distal from the ultrasound
scanner for inserting the cryo-probe therein, and a second opening, proximal to
the ultrasound scanner.
Further still, in accordance with another preferred embodiment of the
present invention, the guide channel includes a groove within the elongated
member. The guide channel has two ends, a first end, distal from the ultrasound
scanner, for inserting the cryo-probe therein, and a second end, proximal to the
ultrasound scanner, for providing an exit point to the cryo-probe.
Furthermore, in accordance with another preferred embodiment of the
present invention, the guide channel further includes at least one retainer
attached to the guide sleeve for retaining the cryo-probe within the groove as the
cryo-probe is advanced therealong.
Further, in accordance with yet another preferred embodiment of the
present invention, the guide channel further includes at least one retainer
attached to the guide sleeve for retaining the cryo-probe within the groove as the
cryo-probe is advanced therealong.
Further, in accordance with still another preferred embodiment of the
present invention, the scanner channel and the guide channel are interconnected
within the sleeve guide.
Furthermore, in accordance with yet another preferred embodiment of
the present invention, the guide sleeve is a detachable guide sleeve.
Further still, in accordance with yet another preferred embodiment of the
present invention, the guide sleeve includes means for aligning the guide sleeve
in a predetermined position relative to the ultrasound scanner for placing the tip of
the cryo-probe within the image plane of the ultrasound scanner as the tip
approaches the target tissue to visualize the path of the tip of the cryo-probe in
the ultrasound image as it approaches and penetrates the target tissue.
Finally, in accordance with another preferred embodiment of the present
invention, the ultrasound scanner is a forward looking ultrasound scanner.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention is herein described, by way of example only, with
reference to the accompanying drawings, wherein:
Fig. 1 is a schematic view illustrating a laparoscopy ultrasound probe
system including a surgical cryo-probe, in accordance with a preferred
embodiment of the present invention;
Fig. 2 is a schematic longitudinal cross- section of the laparoscopy
probe of the laparoscopy ultrasound probe system of Fig. 1 ;
Fig. 3 is a schematic cross section of the guide sleeve of the
laparoscopy probe of Fig. 2 taken along the lines marked III - III;
Fig. 4 is a schematic longitudinal cross section view of part of a
laparoscopy probe having a guide sleeve with a groove shaped guide channel
therein, in accordance with another preferred embodiment of the present
invention;
Fig. 5A is a schematic cross section of the guide sleeve of the
laparoscopy probe of Fig. 4 taken along the lines marked V - V;
Fig. 5B is a transverse cross section of part of a laparoscopy probe (
not Shown) having a guide sleeve with two interconnected channels
accommodating the scanner member and a cryo-probe therein, in accordance
with still another preferred embodiment of the present invention;
Figs. 6A - 9A are schematic views illustrating different steps of a
preferred embodiment of the laparoscopic cryo- surgery method of the present
invention and the positions of the laparoscopy probe and the cryo-probe of the
present invention relative to the target tissue, during these steps; and
Figs. 6B - 9B are schematic views illustrating the images displayed on
the display of the ultrasound system during the steps illustrated in Figs. 6A - 9A,
respectively.
DETAILED DESCRIPTION OF THE INVENTION
Reference is now made to Fig. 1 which is a schematic view illustrating a
laparoscopic ultrasound probe system including a surgical cryo-probe, in
accordance with a preferred embodiment of the present invention. The system 2
includes a laparoscopy system 3 and a cryo-probe system 4. The cryo-probe
system 4 includes a thin cryo-probe 14 suitably connected to a cryo-probe
cooling device 20 and a controller device 24 which controls the cooling device 20 .
The controller device 24 of Fig. 1 is a foot switch, but it can be any other suitable
device for controlling the cooling device 20. By using the controller device 24, the
surgeon can control the cooling of the tip 15 of the cryo-probe 14.
The laparoscopy system 3 includes a laparoscopy probe 12 suitably
connected to a control unit 8 and to a display 6 for generating and displaying an
ultrasound image. The laparoscopy probe 12 includes a handle 18 attached to an
elongated guide sleeve 16. Reference is now made to Fig. 2 which is a
schematic longitudinal cross-section of the laparoscopy ultrasound probe of Fig.
1. The laparoscopy probe 12 includes a scanner member 27 passing through a
scanner channel 28 within the guide sleeve 16. The scanner member 27 is
attached to the handle 18 at one end. The scanner member 27 has an ultrasound
scanner 22 attached to its second end distal from the handle 18. The ultrasound
scanner 22 performs forward looking imaging for providing an ultrasound image of
the organs or tissues positioned in front of the ultrasound scanner 22.
It is noted that for a better understanding, like components are
designated by like reference numerals throughout the various figures.
Further, reference is now made to Fig. 2 which is a schematic
longitudinal cross- section of the laparoscopy probe 12 of Fig. 1. The guide
sleeve 16 also includes a hollow guide channel 26 passing therethrough and
having two open ends 17 and 19. The cryo-probe 14 can be positioned within the
guide channel 26 and can be moved therealong. The tip 15 of the cryo-probe 14
can be retained within the guide channel 26 or can be advanced along the guide
channel 26 such that it protrudes out of the open end 19 of the guide channel 26
while moving parallel to the longitudinal axis of the scanner member 27 (axis not
shown). The ultrasound scanner 22 is connected to the control unit 8 by suitable
connecting wires (not shown for the sake of clarity of illustration) passing through
the scanner member 27, for powering the ultrasonic scanner 22 and for providing
output and control signals to the control unit 8 and the handle 18. The guide
channel 26 ensures that the cryo-probe is placed in the image plane of the
ultrasound scanner as it approaches the target tissue and can therefore be
visualized to confirm a correct path to the target tissue.
In accordance with a preferred embodiment of the present invention, the
guide channel 26 is a longitudinal cavity enclosed within the guide sleeve 16 as
best seen in Fig. 3, to which reference is now made. Fig. 3 is a schematic cross
section of the guide sleeve 16 of Fig. 2 taken along the lines marked III - III.
Reference is now made to Figs. 4 and 5A and 5B. Fig. 4 is a schematic
longitudinal cross section view of part of a laparoscopy probe having a groove
shaped guide channel, in accordance with another preferred embodiment of the
present invention. Fig. 5A is a schematic cross section of the guide sleeve 36 of
Fig. 4 taken along the lines marked V - V. Fig. 5B is a transverse cross section
of part of a laparoscopy probe (not Shown) having a guide sleeve with a single
channel accommodating the scanner member 27 and the cryo-probe 14 therein,
in accordance with still another preferred embodiment of the present invention.
The guide sleeve 36 of Fig. 4 is similar to the guide sleeve 16 of Fig. 2
except that instead of the guide channel 26 of Fig. 2 it includes a guide channel
34 which is shaped as an open groove formed within the guide sleeve 36 as best
seen in Fig. 5A.
The cryo-probe 14 is inserted within the guide channel 34 and can be
kept within it by suitable hooks (not shown) or by other suitable retainers (not
shown) attached to the scanner member 36 and positioned for retaining the
cryo-probe 14 within the guide channel 34. The cryo-probe 14 can be moved
within the guide channel 34 as disclosed hereinabove.
Turning to Fig 5B, the guide sleeve 46 includes therein a scanner
channel 29 and a guide channel 47. The guide channel 47 and the scanner
channel 29 are interconnected as best seen in Fig. 5B. The scanner member 27
passes through the scanner channel 29 and the cryo-probe 14 is inserted and
advanced into the guide channel 47 as disclosed hereinabove for the guide
sleeves 16 and 36.
It is noted that while the sleeve guides 16, 36 and 46 of Figs . 3, 5A and
5B, respectively, are affixed to the handle 18, in accordance with other preferred
embodiments of the present invention, the sleeve guides can be detachably
attached to the handle 18 for enabling cleaning and sterilization of the sleeve
guide.
Additionally, in accordance with another preferred embodiment of the
present invention, the detachable sleeve guide includes one or more alignment
devices so that upon being attached to the handle 18 the detachable guide sleeve
is aligned in a predetermined position relative to the ultrasound scanner 22 such
that the tip 15 of the cryo-probe 14 will be positioned within the imaging plane of
the ultrasound scanner 22 when the cryo-probe 14 is inserted within the guide
channel 26 and the tip 15 approaches the target tissue. For example, the
detachable sleeve guide may include one or more aligning pins (not shown) which
are insertable into matching depressions (not shown) on the handle 18 to suitably
orient the cryo-probe 14 within the image plane of the ultrasound scanner 22.
Alternatively, the alignment devices can be one or more aligning screws
(not shown) which are inserted into suitable aligning holes (not shown) formed
within the guide sleeve and the handle 18, or any other suitable alignment
devices.
In accordance with an exemplary preferred embodiment of the present
invention, the cryo-probe system 4 can be the CRYOcare K2, 2-Probe
cryosurgical system (part number CRYO-22) equipped with a cryo-probe such as
part number CRYO-40 having an external diameter of 3 mm, Commercially
available from ENDOCARE Incorporated, CA, U.S.A. The laparoscopy system 3
can be the SHARPLAN U-SIGHT imaging system commercially available from
Laser Industries Ltd. Israel or from Sharplan Laser Inc., NJ, U.S.A., including the
model 9511 laparoscopy biopsy guide for laparoscopic probe model LP-8, with a
guide channel internal diameter modified to accept the CRYO-40 cryo-probe.
Reference is now made to Figs. 6A - 9A and 6B - 9B. Figs. 6A - 9A are
schematic views illustrating different steps of a preferred embodiment of the
laparoscopic cryo- surgery method of the present invention and the positions of
the laparoscopy probe and the cryo-probe of the present invention relative to the
target tissue, during these steps. Figs. 6B - 9B are schematic views illustrating
the images displayed on the display of the ultrasound system during the steps
illustrated in Figs. 6A - 9A, respectively.
In accordance with an exemplary preferred embodiment of the present
invention, the surgeon starts by making a small incision in the abdominal wall of
the patient using standard surgical methods. The surgeon inserts the end of the
laparoscopy probe 12 to which the ultrasound scanner 22 is attached into the
abdominal cavity of the patient and activates the ultrasound scanner 22 to
generate an ultrasound image. The surgeon then manipulates the laparoscopy
probe 12 until he identifies the image 40A (Fig. 6B) of the target tissue 40 (Fig.
6A) in the ultrasound image 39A presented on the display 6 (Fig. 6). The surgeon
enables a display of a path line 41 B on the ultrasound image 39B (Fig 7B) on the
display 6 of the SHARPLAN U-SIGHT system, indicating the predicted path of the
cryo- probe 14 of Fig 7A (cryo-probe not shown). The surgeon moves the
laparoscopy probe 12 until the predicted path 41 C on the ultrasound image 39C
(Fig. 8B) intersects the image 40C of the target tissue 40 (Fig. 8A). The surgeon
inserts the cryo-probe 14 (Fig. 9A) into the guide channel 26 (not shown) of the
guide sleeve 16 through the opening 17 and advances the cryo-probe 14 until it
exits out of opening 19 and advances towards the target tissue 40.
The surgeon observes the progression of the image (not shown) of the
cryo-probe 14 along the predicted path line 41 C on the ultrasound image 39D as
the cryo-probe 14 penetrates into the target tissue 40 (Fig. 9A).
After the cryo- probe 14 has penetrated the target tissue 40, the surgeon
activates ths cryo-probe cooling device 20 by using the controller device 24. The
cooling device 20 cools the tip 15 of the cryo-probe 14 so that the target tissue 40
is frozen without causing excessive damage to the tissue surrounding the target
tissue 40. The surgeon monitors the freezing of the target tissue on the display 6.
The surgeon then stops the cooling device 20 from cooling the tip 15 of the
cryo-probe 14 or by heating the tip 15 of the cryo-probe 14, by using the controller
device 24. After the target tissue 40 partially or completely thaws, the surgeon
retracts the cryo-probe 14 into the opening 19, withdraws the guide sleeve 16 of
the laparoscopy probe 12 out of the abdominal cavity of the patient and treats the
incision using conventional post- laparoscopy methods.
It is noted that, in contrast to open cryo-surgery using an external
ultrasound probe and to surgery using a laparoscopic probe and a separate
cryo-probe, the surgeon in the system of the present invention, uses only one
hand for manipulating the laparoscopy probe 12, and that after the laparoscopy
probe 12 is properly positioned the surgeon can advance the cryo-probe with the
same hand that holds the laparoscopy probe 12. This facilitates the surgeon's
work, eliminates the requirement of manually coordinating the movements of both
cryo-probe and ultrasound probe encountered during ultrasound assisted open
cryo-surgery, ensures quick directing of the cryo-probe to the target tissue and
facilitates the penetration of the target tissue by providing the surgeon with the
predicted path line of the cryo-probe 14.
Additionally, the method and system disclosed hereinabove have the
advantage of allowing the surgeon to perform ultrasound laparoscopy assisted
cryo-surgery for selective freezing of tumors or other types of target tissues within
organs which cannot be visualized using optical laparoscopy devices, thus
obviating the need for performing open surgery and significantly reducing the
chances of infection, shortening surgery duration, and leading to shorter
post-operative hospitalization periods.
It is noted that while the present invention is disclosed as being
performed on humans, it can be adapted for use with animals.
It will be appreciated by those skilled in the art that, while the system
and method of the present invention were disclosed as adapted to performing
abdominal laparoscopy and cryo-surgery, other preferred embodiments of the
present invention may be adapted for performing other types of ultrasound
endoscopy assisted cryo-surgery which are included within the scope of the
present invention.
While the invention has been described with respect to a limited number
of embodiments, it will be appreciated that many variations, modifications and
other applications of the invention may be made.