U.S. patent application number 17/133551 was filed with the patent office on 2022-01-13 for apparatus and ethods for hybrid endoscopic and laparoscopic surgery.
This patent application is currently assigned to Modular Surgical, Inc.. The applicant listed for this patent is Modular Surgical, Inc.. Invention is credited to Amir Belson, James J. Leary.
Application Number | 20220008047 17/133551 |
Document ID | / |
Family ID | 1000005855516 |
Filed Date | 2022-01-13 |
United States Patent
Application |
20220008047 |
Kind Code |
A1 |
Belson; Amir ; et
al. |
January 13, 2022 |
APPARATUS AND ETHODS FOR HYBRID ENDOSCOPIC AND LAPAROSCOPIC
SURGERY
Abstract
Apparatus and methods are described allow the techniques of
endoscopic and laparoscopic surgery to be combined into a minimally
invasive hybrid surgical technique called NOTES-assisted
laparoscopic surgery. Manual and robotic-controlled versions of a
modular laparoscopic tool are described having a small diameter
shaft that is delivered laparoscopically to a surgical site. Larger
diameter working tips are delivered through a NOTES delivery tube
inserted to the surgical site through a natural orifice and joined
to the shaft of the modular laparoscopic tool. Larger diameter
working tips improve the effectiveness of the modular laparoscopic
tools and the number and size of laparoscopic ports used can also
be reduced.
Inventors: |
Belson; Amir; (Cupertino,
CA) ; Leary; James J.; (St. Louis, MO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Modular Surgical, Inc. |
Cupertino |
CA |
US |
|
|
Assignee: |
Modular Surgical, Inc.
Cupertino
CA
|
Family ID: |
1000005855516 |
Appl. No.: |
17/133551 |
Filed: |
December 23, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14338237 |
Jul 22, 2014 |
10898173 |
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17133551 |
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13728930 |
Dec 27, 2012 |
8827988 |
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14338237 |
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13380198 |
Jul 20, 2012 |
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PCT/US2010/000584 |
Feb 26, 2010 |
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13728930 |
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61208793 |
Feb 27, 2009 |
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61216304 |
May 14, 2009 |
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61275360 |
Aug 28, 2009 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2090/3614 20160201;
A61B 1/3132 20130101; A61B 2017/2931 20130101; A61B 17/00 20130101;
A61B 1/32 20130101; A61B 1/04 20130101; A61B 2017/00464 20130101;
A61B 17/0483 20130101; A61B 2017/00278 20130101; A61B 34/30
20160201; A61B 2090/306 20160201; A61B 17/29 20130101; A61B 1/00087
20130101; A61B 17/3423 20130101; A61B 2017/2901 20130101; A61B
17/3201 20130101; A61B 2017/2902 20130101; A61B 2017/00411
20130101; A61B 2017/2943 20130101; A61B 2017/00477 20130101; A61B
2017/00544 20130101; A61B 90/361 20160201; A61B 2017/00539
20130101; A61B 2017/00362 20130101; A61B 17/0218 20130101; A61B
2017/00876 20130101; A61B 17/00234 20130101; A61B 17/0469 20130101;
A61B 34/37 20160201 |
International
Class: |
A61B 17/00 20060101
A61B017/00; A61B 17/34 20060101 A61B017/34; A61B 34/30 20060101
A61B034/30; A61B 34/37 20060101 A61B034/37; A61B 90/00 20060101
A61B090/00; A61B 17/04 20060101 A61B017/04; A61B 1/00 20060101
A61B001/00; A61B 1/04 20060101 A61B001/04; A61B 1/313 20060101
A61B001/313; A61B 1/32 20060101 A61B001/32; A61B 17/02 20060101
A61B017/02; A61B 17/29 20060101 A61B017/29; A61B 17/3201 20060101
A61B017/3201 |
Claims
1. A surgical tool system comprising: a surgical tool shaft having
a distal end configured to be advanced through a laparoscopic port
into a location within a patient's body and a proximal end
configured to remain outside of the patient's body; a handle
attached to the proximal end of the shaft; a magnetizable surgical
tool tip detachably connectable to the distal end of the surgical
tool shaft; and a magnet on the shaft configured to attract the
surgical tool tip and align said tip with the shaft, wherein the
surgical tool tip mechanically engages the shaft after magnetic
alignment.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 14/338,237 (Attorney Docket No.
42369-703.304), filed Jul. 22, 2014, which is a continuation of
U.S. patent application Ser. No. 13/728,930 (Attorney Docket No.
42369-703.301, now U.S. Pat. No. 8,827,988), filed Dec. 27, 2012,
which is a continuation of U.S. patent application Ser. No.
13/380,198 (Attorney Docket No. 42369-703.831), filed Dec. 22,
2011, which is a 371 National Stage Application of PCT Application
No. PCT/US2010/000584 (Attorney Docket No. 42369-703.601), filed
Feb. 26, 2010, which claims priority from provisional application
No. 61/208,793 (Attorney Docket No. 42369-703.101), filed on Feb.
26, 2009; provisional application No. 61/216,304 (Attorney Docket
No. 42369-703.102), filed on May 14, 2009; and provisional
application No. 61/275,360 (Attorney Docket No. 42369-703.103),
filed on Aug. 28, 2009, the full disclosures of which are
incorporated herein by reference.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The present invention relates generally to apparatus and
methods for performing surgery. In particular, it relates to
apparatus and methods that combine the techniques of endoscopic and
laparoscopic surgery in a minimally invasive hybrid surgical
technique. The apparatus and methods of the invention can be
implemented using manual or robotic instruments.
[0003] Laparoscopy was an evolution from open abdominal surgery.
Laparoscopy offered faster recovery, reduction in pain and less
scarring post surgery. Compared with open surgery, where the
surgeon manipulates the tissue and performs the surgery when the
entire surgical field is exposed, the laparoscopic procedure
required significant training. The learning curve was slow and it
took a large number of procedures to be performed before the
surgeon mastered the mental, as well as manual, demands of the
technique and the procedure time was shortened.
[0004] In the last few years, as part of the tendency to perform
less invasive procedures surgeons started performing natural
orifice transluminal endoscopic surgeries (NOTES) where the scope
is introduced to the peritoneal space via the stomach, anus, vagina
or umbilicus. This approach eliminates the need to cross the skin
and the musculature to get to the peritoneal space, which reduces
the pain even further, helps cosmetically and may even help to
reduce the adhesion rate.
[0005] The problem is that this approach requires the use of
flexible and controllable delivery platforms and endoscopes so that
they can navigate in the tortuous path of the GI tract and in
between organs in the peritoneum. Those devices need to be stiff
enough during tissue manipulation, but flexible enough when passing
in the GI tract, vagina or colon. For surgeons that are used to
laparoscopy (rigid tools), it is not easy to get used to the image
during endoscopy, particularly during retroflection with flexible
endoscopes.
[0006] One of the big advantages that transluminal surgery has to
offer is the ability to extract big bulks of tissue or organs
through the opening in the stomach, vagina or colon without causing
more pain.
[0007] Because of the technical challenges involved and the lack of
appropriate tools, most of the NOTES surgeries reported in the
medical literature have been performed using hybrid procedures that
combine endoscopic and laparoscopic surgical techniques (also
described as endo-laparoscopic surgery) or using transvaginal
access in upper abdominal surgeries and transgastric in lower
abdominal procedures. Many of the pioneers in NOTES surgery
consider this hybrid approach to be only an intermediate step or a
bridge to true endoscopic NOTES surgery, their stated goal being to
entirely eliminate the laparoscopic component of the surgery. To
the present inventor, however, this approach seems idealistic and
somewhat short sighted. Greater advantages can be achieved for the
benefit of the patient and the convenience of the surgeon by
retaining the laparoscopic component, while minimizing the
invasiveness and simultaneously improving the effectiveness of the
laparoscopic tools used. This can be achieved by utilizing modular
laparoscopy tools with very thin shafts to minimize the puncture
size needed to insert the tools through the abdominal wall and
using the NOTES endoscope working channel or an overtube or tube as
a conduit to deliver the larger diameter working tips of the
modular laparoscopy tools that will attach to the shaft or shafts
inside the body. Alternatively, a single larger laparoscopic
cannula can be used to deliver the larger diameter working tips of
the modular laparoscopy tools to the surgical site. For this
approach, the preferred location can be the umbilicus--for better
cosmetic outcome.
[0008] If laparoscopy or thoracoscopy would employ very small tools
(in the range of 2-5 mm) then pain will be significantly reduced
and so also will be the risk for hernia at the incision site.
SUMMARY OF THE INVENTION
[0009] This patent describes the combination of natural orifice
transluminal endoscopic surgery (NOTES) with small laparoscopic
instruments (with very small shafts). The patent describes a way to
maintain the laparoscope instruments' surgical abilities and
operating techniques with the reductions of its size.
[0010] The invention provides a modular laparoscopic surgery tool
with a small shaft that is introduced through the skin either
directly or through a trocar sheath and that connects to a tip that
is delivered through another port, either through the skin or
through a natural orifice, where the shaft moves the tip in space
and controls the actuation of the tip or delivers the tip to a
target location and secures it there.
[0011] The invention also provides a modular laparoscopic surgery
tool with a connector that is easy to connect and disconnect, that
connects a small shaft to a bigger tip where the connector either
delivers the actuation force needed for the actuation of the tip
and/or delivers the energy required for an actuation element that
is located inside the tip and/or delivers control signals to a tip
that has both an actuation element (like a motor) and energy source
(like a battery) where the shaft also holds the tip in space and
moves the entire tip from one spot to another in space.
[0012] The shaft of the modular laparoscopic surgery tool will
optionally include both actuation means or energy delivery means or
control signal delivery means and a rigid structure that holds and
moves the tip around.
[0013] Optionally, the connector will enable transfer of hydraulic
force from the shaft to the tip while also controlling the tip's
position in space and moving it around.
[0014] Optionally, the connector will enable transfer of pneumatic
force from the shaft to the tip while also controlling the tip's
position in space and moving it around.
[0015] Optionally, the connector will enable transfer of rotation
force from the shaft to the tip while also controlling the tip's
position in space and moving it around.
[0016] Optionally, the connector will enable transfer of mechanical
push force from the shaft to the tip while also controlling the
tip's position in space and moving it around. Optionally, the
connector will enable transfer of magnetic force from the shaft to
the tip while also controlling the tip's position in space and
moving it around.
[0017] Optionally, the connector will enable transfer of electrical
energy from the shaft to the tip while also controlling the tip's
position in space and moving it around.
[0018] Optionally, the connector will enable transfer of any other
type of energy, such as RF, etc. from the shaft to the tip while
also controlling the tip's position in space and moving it
around.
[0019] Optionally, the connector will enable transfer of light from
the shaft to the tip or image from the tip to the shaft while also
controlling the tip's position in space and moving it around.
[0020] Optionally, the connector will enable transfer of digital
image signals from the tip to the shaft while also controlling the
tip's position in space and moving it around.
[0021] The system may include a stereoscopic image module to
provide the operator with a three dimensional image.
[0022] In one embodiment, a camera will be delivered with the other
tips through a port different than the shaft port. Optionally, the
camera may provide stereoscopic imaging. The shaft may then connect
to the camera and deliver it to a preferred location and then
anchor it at the preferred location (like the abdominal wall). The
shaft then will disconnect from the camera. The camera may be
connected to the image processor with a wire that will run through
the overtube, through another port or will transmit the images
wirelessly or through a small cable through the abdominal wall (or
small needle). Optionally, the camera may be anchored against the
abdominal wall using an external magnet. A motor or other actuator
may be used to aim the camera via remote control or thorough an
umbilical cable after it is in place and to control the zoom in and
zoom out. This same method may be used for insertion and placement
of one or more illumination devices into the surgical site. The
system may use magnetic energy or RF energy or any other type of
energy that will cross the abdominal wall and energize the camera
and or the lights. The first engagement of the shaft and the camera
can also be visualized through a small needle through the skin or
using a fiber optic cable that will run in or along the shaft.
[0023] In order to connect the shaft to the camera at the start of
the procedure, images of the approaching shaft (to the camera) may
be visualized via the camera that is delivered with the tips or via
an optic fiber that will run in or outside the shaft.
[0024] The camera and/or the light projectors will have means for
easy attachment and detachment to and from the internal abdominal
wall (active or passive). In the same way, a light source, based on
optic fibers will deliver light from the outside or LEDs that will
get their energy through a cable that will run through the overtube
or another port. They may also have batteries. They may also be
energized through charging energy that will be delivered through
the abdominal wall. The tip will carry the light source and will
anchor it in a preferred location, such as the internal abdominal
wall.
[0025] One of the tips that will be delivered through the overtube
or separate port may be an ultrasound transducer that will be
carried to the desired location using the thin shaft. This
transducer may be connected to the outside with a cable that will
deliver the signals to the processor.
[0026] A different tip that may be delivered to the site in the
same way may be a projector that may project on the internal organs
images that were taken in earlier imaging studies. For example, the
projector, which will be a tip that will be delivered, could be
attached to the internal abdominal wall and project a CT image of
the liver on the actual liver so that the operator will be able to
know where is the location of internal findings in the liver that
were found in a prior imaging study.
[0027] In yet another example, the overtube may be used to deliver
clips, sutures, loops, needles and other accessories that will be
needed for the surgery and may be employed or deployed by a tip
that was also delivered the same way.
[0028] The camera or the light source may be held in place and be
manipulated using a magnet that will be held outside the
abdomen.
[0029] Optionally, the connector will enable transfer of rotational
force form the shaft to the tip while also controlling the tip's
position in space and moving it around. Optionally, the connector
will enable delivery of electric signals from the shaft to
actuation motors that will be housed in the tip and will actuate
the tip while also controlling the tip's position in space and
moving it around.
[0030] The connector will hold the tip stable relative to the shaft
and will essentially make the shaft and tip one unit such that the
tip will be carried in space while connected to the distal shaft
and according to the movement that the operator gives the
handle.
[0031] The shaft may be made of a single rigid unit or may have a
controllable distal part or another part proximal to the distal
part, in such a way that the operator will be able to steer the
distal part of the shaft so that it will have a position with some
angle different than 180 degrees from the proximal shaft.
[0032] The shaft could be hollow or solid and could potentially
have a telescopic structure.
[0033] Unlike prior art, the current shaft may connect to different
tips, move them in space and actuate them during a single
surgery.
[0034] In one option, different small shafts will be used for
different tips. The different tool shaft will be exchanged during
the surgery as needed. For example when a grasper is needed, a
grasping shaft will be inserted through the skin or through a
trocar sheath and connect inside the abdominal cavity to a grasping
tip. Then, if an electrocautery tool will be needed, the grasping
tip will be separated from the shaft in the abdomen, the grasper
shaft will be withdrawn and an electrocautery shaft will be
inserted, preferably through the same hole.
[0035] In another option, the external shaft will stay in place and
the internal part, which in one example actuates the tip, will be
exchanged with the handle controlling actuation of the new tip.
[0036] In a preferred example, a single shaft will be able to
control different tips so that the shaft will not have to be
exchanged.
[0037] Preferably, the step of connecting the tip to the shaft can
be performed away from abdominal wall and with no need for contact
with the abdominal wall.
[0038] Preferably the tip will be able to manipulate the tissue at
or close to the organ bed without the need to move the organ or
tissue away from the organ bed.
[0039] In a manually operated version of the modular laparoscopic
surgery tool, a handle connected to the proximal end of the shaft
will be controlled by the operator directly allowing the operator
to actuate the working tip, as well as to control the tip's
position in space and move it around. The handle can be translated
and rotated as well as inserted and withdrawn to manually control
the position of the tip in three dimensions.
[0040] In a robotically operated version of the modular
laparoscopic surgery tool, the working tip of the tool may be
configured with a robotic end effector that is operated through the
shaft of the tool, which is connected to a robotic surgical system
located outside of the patient's body. Also, the shaft may be
controlled and manipulated in space robotically.
[0041] Alternatively, in a robotically operated version of the
modular laparoscopic surgery tool, the working tip of the tool may
be configured with a robotic end effector that is operated remotely
in a master/slave relationship with a robotic surgical system.
[0042] In the robotic version of the invention the operator may not
physically touch the handle or the proximal shaft but rather work
from a remote working station in a master slave fashion.
[0043] The different tips will be delivered through the overtube,
tube or endoscope one at a time or more preferably the tips will be
housed in a mechanical structure (cassette) and be delivered
together to the abdominal space or thoracic space. The cassette
will optionally have a structure (like legs or a base) that will
enable a stable position in the peritoneal cavity on top of the
different organs.
[0044] In addition to hybrid NOTES-assisted laparoscopic surgery,
many of the methods and apparatus described herein can also be used
to facilitate other surgical approaches, including, but not limited
to NOTES-assisted NOTES surgery, where two or more NOTES devices
are inserted through different bodily orifices to a surgical site.
Working tips can be inserted through one of the NOTES devices and
another NOTES device with an elongated shaft like the laparoscopic
tools described herein can be inserted through the other NOTES
device, optionally being inserted through the wall of an internal
organ into the thoracic or abdominal cavity. The working tip can be
joined to the elongated shaft inside of the body cavity. This
approach can minimize the size and number of internal incisions
that must be made for surgical access, just as the hybrid
NOTES-assisted laparoscopic surgery can minimize the size and
number of laparoscopic ports that are made.
BRIEF DESCRIPTION OF THE DRAWINGS
[0045] FIGS. 1A-1F show variations of a laparoscopic instrument
shaft without the tip.
[0046] FIGS. 2A-2B show a delivery tube used to deliver the tips to
the laparoscopic instrument shaft.
[0047] FIG. 3 shows a delivery tube that uses a pulley to bring the
tips forward.
[0048] FIG. 4 illustrates positive pressure used to insert the tip
in.
[0049] FIGS. 5A-5B show a cassette that may include multiple tips
and be delivered into the peritoneal cavity.
[0050] FIGS. 6A-6B illustrate a magnetic connection between the tip
and the tube.
[0051] FIG. 7 illustrates a rotation motion that will screw the
shaft and the tip together.
[0052] FIG. 8 shows an electric connection between the shaft and
the tip.
[0053] FIG. 9 illustrates a motor located in the tip for tip
operation.
[0054] FIGS. 10A-10B illustrates actuation of the tip using a cable
in the shaft that connects to a cable in the tip.
[0055] FIG. 11 illustrates tip actuation using a gear system.
[0056] FIGS. 12A-12B illustrate how a lateral motion for tip
actuation is generated by pulling a cable that runs along the
shaft.
[0057] FIGS. 13A-13C show a cable that transmits rotation to the
tip through a connector.
[0058] FIG. 14 shows a connector that connects an optic cable that
delivers light to the tip.
[0059] FIGS. 15A-15B shows how hydraulic and pneumatic pressure can
actuate the tip.
[0060] FIG. 16 shows a shaft with a mechanism to transfer heat to
the tip.
[0061] FIG. 17 shows a connector that enables flow of gas or liquid
in order to inflate parts of the tip.
[0062] FIG. 18 shows how a big tip can be delivered through a big
trocar and connected to a small trocar that is delivered in another
site.
[0063] FIG. 19 illustrates a modular laparoscopy tool that uses
suction to engage the working tip with the shaft.
[0064] FIG. 20 illustrates an exploded view of a modular
laparoscopy tool with a T-shaped ionnector on the distal end of the
shaft.
[0065] FIGS. 21-22 illustrate a T-shaped connector where the
connection elements fold to give the shaft the lowest possible
profile for insertion.
[0066] FIGS. 23A-23B illustrate a working tip delivery tool that
can be used to deliver a working tip to the surgical site.
[0067] FIGS. 24-25 illustrate an overtube with an expandable jaw
that turns the overtube into a working tip delivery tool.
[0068] FIGS. 26-28 illustrate a working tip delivery tool that can
be used to deliver multiple interchangeable working tips to the
surgical site through the lumen of the NOTES device.
[0069] FIG. 29 shows a modular laparoscopy tool with a magnet
around the shaft to attract the tip with the right alignment
relative to the shaft.
[0070] FIGS. 30-35 show perspective views of a tool tip cassette
that can be used with the modular laparoscopy tool.
[0071] FIG. 36 illustrates apparatus for robotic assisted hybrid
endoscopic and laparoscopic surgery.
[0072] FIG. 37 illustrates a prior art robotic end effector for
laparoscopic surgery.
[0073] FIGS. 38-39 illustrate a modular robotic laparoscopic tool
adapted for use in the improved apparatus and methods for robotic
assisted hybrid endoscopic and laparoscopic surgery of the present
invention.
[0074] FIGS. 40-42 illustrate a manually operated surgical tool
according to the present invention.
[0075] FIGS. 43-44 show a mechanical tip for the surgical tool.
[0076] FIGS. 45-52 illustrate a mechanism for engaging and
disengaging the mechanical tip.
[0077] FIGS. 53-55 show a robotic system that includes
electro-mechanical tips and electro mechanical handles.
[0078] FIGS. 56-57 show a grasper or needle holder end
effecter.
[0079] FIG. 58 shows a scissor end effecter.
[0080] FIGS. 59-60 show a retractor end effecter.
[0081] FIGS. 61-62 illustrate a modular laparoscopic tool that has
a proximal assembly with a plurality of small diameter shafts that
extend distally from a common handle and an attachable/detachable
working tip.
[0082] FIG. 63 shows a shaft alignment template for use with the
modular laparoscopic tool of FIGS. 61-62.
DETAILED DESCRIPTION OF THE INVENTION
[0083] The present invention utilizes small diameter and
potentially rigid shafts that will be inserted into the peritoneal
or thoracic cavity through the skin (through canullas or directly
through the skin) and then their distal end will be connected to a
tip that will be delivered to the peritoneal or thoracic cavity via
a NOTES approach. Once this connection will be established, the
handle or any other user interface that will be located at the
proximal part of the rod or shaft or along the shaft, outside the
body, will be able to control the new tip that will be added to the
device inside the peritoneal or thoracic cavity. This connection
will make the device operable. The tip will then respond to changes
that will be applied on the proximal part of the shaft or the tip
will deliver information such as images from the space to the
proximal part or any other device such a monitor that will be
connected to the shaft.
[0084] It should be noted that the tip may also be connected to the
shaft inside of an organ in the patient's body in order to
facilitate internal surgery within the organ. For example, for
performing intragastric surgery, the tip can be delivered through
the esophagus into the stomach and attached to a shaft inserted
through the abdominal wall and through a small opening or incision
in the gastric wall into the stomach. Similarly, tips for
performing intrauterine surgery can be delivered through the vagina
and attached to a shaft inserted laparoscopically into the
uterus.
[0085] The tip will be delivered through a NOTES approach either
through an endoscope or through a tube (like an overtube) that will
be placed between the natural orifice and the opening to the
peritoneum and potentially will extend a little bit into the
peritoneum. The tips that may be inserted to the proximal part of
the scope or tube will be pushed manually, robotically, via air
pressure or fluid pressure into the peritoneal space. Another
option would be to have a pulley at the end of the tube or working
channel of the scope or the distal part of the tube and after
connecting the tip to the wire (outside the body) the wire will run
over the pulley and come back proximally; pulling the wire will
bring the tip to the distal end of the tube or scope. At the end of
the tube or scope (inside the peritoneum) there may be a net or any
other structure that will accept the tip and may host several tips.
If air pressure will be used to push the tips in, the net will
cover the opening of the working channel of the tube and stop the
motion of the tip.
[0086] If an overtube is used, it may be placed using an endoscope.
Tools that will be delivered via the working channel will be used
to open the organ wall (stomach as an example). The scope with the
tube around it will be pushed into the peritoneal cavity and the
scope may then be pulled outside, leaving the tube in place with
its proximal part outside of the body and the distal part in the
peritoneum. After the scope is removed, the overtube will be used
as a delivery conduit to deliver tips to be attached to the
laparoscopy tools. Then, the overtube will be covered (either at
its distal orifice, the proximal orifice or in between them) so
that the insufflation pressure will not leak. In another option,
the tube will be used to constantly deliver more pressure, as
needed, to keep the abdominal space insufflated. A valve may be
used that allows insertion and removal of the tips or other tools
without significant loss of insufflation pressure.
[0087] At the end of the surgery if an organ or tissue needs to be
taken out, it will be retrieved whole or in pieces through the
overtube or the working channels or directly through the natural
orifice that was used for access. The tips or tips cassette will
also be withdrawn through the overtube, scope or organ directly.
One option would be to use suction for quick withdrawal of the tips
and tissue.
[0088] In order to close the opening in the organ (such as stomach)
one option would be to insert the endoscope again through the tube,
retract the tube and scope into the organ cavity (such as stomach)
and deliver closing endoscopic tools to close the wall). Another
option would be to place sutures, such as purse string suture) in
the stomach (or other entry organ) wall, around the tube, during
the surgery, so that upon retraction of the tube, with or without
an endoscope in it, the suture will be tied and the opening will be
closed.
[0089] There are three stages that are required:
[0090] The first is engaging the tip to the shaft. That could be
done in several different ways. As an example, magnetic force may
be used via a magnet or electromagnet to approximate the tip to the
shaft and hold them together as a second optional mechanism will be
applied to strengthen the connection. Such force may include
torquing a threaded element, like a screw, into an internally
threaded structure (like a hole or tube). If a secondary mechanism
will be used, the electromagnet could not be used anymore (and the
electric power could be discontinued to the electromagnet). Other
mechanisms to connect the tip to the shaft could be actuated by
motors that may be located within the tip or the shaft. Other
mechanisms may include using a key to lock the tip to the shaft.
Any other possible connecting mechanism can be used for engaging
the tip and the shaft. Optionally, an engagement indicator will be
used to indicate to the operator that the connection was
successful.
[0091] The second is activating the tip to perform the work it is
designed to do. This could include opening and closing grasper jaws
or scissors, applying electric current in electrocautery or
electric cutting, delivering light through a light connector for
illumination, carrying a picture or video signal in a laparoscope,
opening and closing a basket, opening and closing a stapler and
operating the stapler's cutting element, rotating a helical needle,
suturing with a suturing device, applying suction through a suction
connector or delivering air or other gasses, applying clips to the
tissue, delivering other types of energy such as RF or laser or
X-rays, actively or passively retracting tissue, opening and
closing snares, deliver negative pressure (suction), irrigation,
and local insufflations, applying tags or performing any other
action that is needed during the surgery and for which the specific
tool was designed to do.
[0092] The third stage is disconnecting the tip from the shaft.
This step will optionally be done inside the net or the mechanism
that is used to hold the tip when it is not connected to the shaft
(the cassette as an example). Optionally there may be a dedicating
mechanism to separate the tip from the shaft, such as: a special
"tooth" that will be pushed forward for the separation, air
pressure, a bellows, a balloon, torque in the opposite direction or
any other possible way.
[0093] During this stage, if tissue needs to be evacuated from the
surgical field, it could be done through the transluminal
access.
[0094] An indicator may be used to indicate that the tip is
successfully disengaged from the shaft and is successfully engaged
in the tip structure.
[0095] In general the idea is to use the smallest possible holes in
the abdominal wall for minimal scarring and pain and to minimize
the risk of hernia and to use the NOTES access to deliver the big
tip of the laparoscopic instruments and to retrieve tissue or
organs.
[0096] Essentially, the surgeon will perform a laparoscopic
procedure and the patient will benefit from the NOTES
advantages.
[0097] The following figures will demonstrate some of the
options:
[0098] The same principal of connecting a big tip to a small shaft
and enabling the tips functionality through the connection could be
done when the tip is delivered in another way, not through a NOTES
approach, for example through one bigger opening in the skin. In
such an approach a single port will be used to deliver bigger
trocars or surgical tools and also to deliver big tips that will be
connected inside the body to small shafts that will be inserted in
a different site.
[0099] FIGS. 1A-1F show variations of a laparoscopic instrument
shaft 102, having handle 201, and without the tip. The distal end
104 of the shaft 102 may be sharp to enable penetration through the
abdominal wall A (FIG. 1A), helical or threaded 106 to enable slow
and controlled insertion (screwing) through the abdominal wall
where the entire shaft will have to be rotated to insert (FIG. 1B)
or just the threaded lower part 106 will need to be rotated with a
rotating mechanism 108 to insert (FIG. 1C) or using a retractable
sharp mechanism 110 for safety (FIG. 1D-IE). It could also be blunt
112 (FIG. 1F) (especially if it is inserted through an
introducer).
[0100] FIG. 2 A shows a delivery tube 120 (optionally configured as
an overtube for an endoscope) that will be used to deliver the
working tips of the modular laparoscopic surgical tool into the
patient's body. As shown in FIG. 2B, a seal 122 or valve may be
provided at the proximal end of the delivery tube 120 or another
desired location to close the internal lumen and prevent
insufflation pressure from leaking after the working tip has been
inserted. The tips could be delivered via working channel/s of an
endoscope as well. The tube may be continuously used to maintain
the desired intra abdominal pressure by delivering extra pressure
or evacuating some gas (preferable CO2 or Nitrogen) from the
peritoneal cavity. The delivery tube 120 can be rigid, semi rigid
or flexible. Optionally, the delivery tube 120 may be expandable or
stretchable and collapsible so that it can expand to accommodate
the passage of a larger diameter working tip, but can collapse so
that it does not occupy the entire body lumen when it is not
needed. This will greatly improve patient comfort during surgery
performed with NOTES assistance through a delivery tube 120 placed
in the patient's esophagus.
[0101] FIG. 3 shows a delivery tube 120 that uses a pulley 124 to
bring the tips 130 forward.
[0102] FIG. 4 illustrates positive pressure 126 from a pressure
source 128 used to advance the tip 130 through the delivery tube
120. A net 132 may be used to catch the tips at the distal end of
the tube.
[0103] FIGS. 5A-5B show a cassette 140 that may include multiple
tips 130A through 130C and be delivered into the peritoneal cavity.
FIG. 5 A shows the cassette 140 during delivery. FIG. 5B shows the
cassette 140 in the peritoneum P.
[0104] FIGS. 6A-6B illustrate a magnetic connection 134 between the
tip 130 and the shaft 102. FIG. 6A shows the magnetic connection
being made. FIG. 6B shows the option to create a mechanical
connection 136 after the magnetic connection has been made.
[0105] FIG. 7 illustrates a rotation motion that will screw a
threaded end 106 on the shaft 102 into a threaded receiver 107 in
the tip 130 or vice versa. The rotation can be created by rotation
of the entire shaft or rotation of part of the shaft. The rotation
can be done by a drive shaft that will deliver rotation from the
outside, a motor that will be in the tip, a motor in the shaft,
pneumatic or hydraulic force.
[0106] FIG. 8 shows an electric connection 138 between the shaft
102 and the tip 130 that enables delivery of electrical energy to
the tip or deliver energy or signals (like images) back proximally.
The electricity could also be used to activate an electroactive
polymer based tip. The electric connection 138 may also be used to
deliver operation signals to an actuating unit, such as a motor, in
the tip. Optionally, in this embodiment and other embodiments of
the modular laparoscopic tool 100, the tip 130 may have a tapered
or funnel-shaped socket 131 to help align the tip 130 to the shaft
102 during the connection step.
[0107] FIG. 9 illustrates a motor 150 located in the tip 130 to
enable actuation that will be required for the tip operation. The
command to the motor 150 and the energy required could potentially
run along the shaft 102 and through a connector between the shaft
and the tip or through an electrical cable 152 in the shaft 102, if
it is hollow.
[0108] FIGS. 10A-10B illustrate how the actuation of the tip 130
could be delivered using a mechanical cable 154 that will run along
the shaft 102 and connect via a connection mechanism 158 to a cable
156 or other actuation mechanism in the tip. An example of a
connection mechanism 158 is a magnetic connection, ball and socket,
screw etc. Pulling the cable 154 in the shaft 102 will pull the
cable 156 in the tip 130 and that will be used for actuation of an
end effector 160, such as a grasper.
[0109] FIG. 11 illustrates another example of actuation using a
gear system. A gear 162 in the shaft 102 can rotate a gear 164 in
the tip 130 once they come in contact. The gear 162 in the shaft
102 can be rotated via air pressure, fluid pressure, drive shaft
166, rotation shaft etc. The gears can generate linear motion,
lateral motion and any other direction.
[0110] FIGS. 12A-12B illustrates how a lateral motion 170 at the
tip 130 (for actuation) can be generated by pulling a cable 168
that runs along the shaft 102 and connector 202.
[0111] FIG. 13 A shows a drive shaft 166 that can transmit rotation
and which is connected to the tip 130 and, through the connector
172, transmits the rotation to the tip 130 for the tip's operation.
FIG. 13B shows the connector 172 before engagement. FIG. 13C shows
the connector 172 engaged.
[0112] FIG. 14 shows an optical connector 174 that connects an
optic cable 176 to optic cable 203 that delivers light (laser for
example) to the tip 130 so that the light will be used for the
procedure, for example for laser cutting, ablation or for cautery.
The tip may also include a lens 177.
[0113] FIGS. 15A-15B shows how hydraulic and pneumatic pressure
from a pressure line 178 in the shaft 102 delivered through a
connector 180 can actuate the tip 130.
[0114] FIG. 16 shows a shaft 102 with a mechanism to transfer heat
to the tip 130. The shaft may also have a connector 186 with a
valve 182 that will allow a heat transfer fluid to flow from a tube
184 in the shaft 102 to the tip (use of heated or cooled gas,
frozen mist or liquid nitrogen, as an example). Optionally, a
return path for the heat transfer fluid may also be provided in the
shaft 102.
[0115] FIG. 17 shows a shaft 102 with a connector 190 with a valve
192 that enables flow of gas or liquid in order to inflate part 194
of the tip 130 or the entire tip. The gas/liquid could be delivered
from the outside through the shaft 102 into the tip 130, through
the connector 190. The inflatable part 194 may be a balloon, a
tissue elevator, an inflatable actuator, etc.
[0116] FIG. 18 shows how a big tip 130 can be delivered through a
big trocar sheath 200 and connected to a small shaft 102 that is
delivered in another site. The shaft 102 can be inserted through a
smaller trocar sheath or directly through an opening or incision
made in the skin S.
[0117] FIG. 19 illustrates a modular laparoscopy tool 100 that uses
suction 202 to engage the working tip 130 with the shaft 102. After
the working tip 130 has engaged the shaft 102, a mechanical
connection may optionally be made between the working tip 130 and
the shaft 102. Disengagement may be accomplished by a positive
pressure and/or corresponding mechanical disengagement.
[0118] FIG. 20 illustrates an exploded view of a modular
laparoscopy tool 100 with a T-shaped or key-like connector 204 on
the distal end of the shaft 102 that inserts into a cooperating
slot 206 on the working tip and rotates to connect the working tip
130 to the shaft 102. Optionally, the laterally-extending pins 208
of the T-shaped connector 204 may be used for controlling and
actuating the working tip 103 of the modular laparoscopy tool
100.
[0119] FIGS. 21-22 illustrate a variation of the T-shaped connector
204 where the connection elements 208 fold to give the shaft 102
the lowest possible profile for insertion.
[0120] Optionally, a shaft 102 may have a plurality of connection
points for attaching and operating a plurality of working tips 130
with a single shaft 102.
[0121] FIGS. 23A-23B illustrate a working tip delivery tool 210
that can be used to deliver a working tip to the surgical site
through the lumen of the NOTES device. The delivery tool 210 has an
expandable jaw 212 that closes (FIG. 23A) to hold the working tip
and expands (FIG. 23B) to release the working tip after it has been
attached to the shaft.
[0122] FIGS. 24-25 illustrate a NOTES overtube 120, as described
above, with the additional feature of an expandable jaw 214 that
turns the overtube 120 into a working tip delivery tool. The
expandable jaw 214 closes to hold the working tip and expands to
release the working tip after it has been attached to the shaft.
Optionally, a distal portion of the overtube 120 may be made with a
stretchable material 216 that allows the overtube 120 to stretch
with the expandable jaw 214.
[0123] Optionally, the NOTES overtube 120 may have an anchoring
mechanism at the distal end or a more proximal location, such as a
ring-shaped balloon that can be inflated with gas or liquid to
prevent the overtube 120 from being inadvertently withdrawn or
moved from its working position in the peritoneum or thoracic
cavity.
[0124] FIGS. 26-28 illustrate a working tip delivery tool 220 that
can be used to deliver multiple interchangeable working tips 130 to
the surgical site through the lumen of the NOTES device 120.
Optionally, the delivery tool 220 will be configured to provide a
"docking station" that presents the interchangeable working tips
130 in an orientation for easy attachment to the shaft of the
modular laparoscopy tool. By way of example, FIG. 26 shows the
delivery tool 220 being inserted through the lumen of a NOTES
overtube 120. FIG. 27 shows the delivery tool 220 pushed out of the
distal end of the overtube 120 within the body cavity by an
elongated member 222. FIG. 28 shows the delivery tool 220 pulled
back against the distal end of the overtube 120 by the elongated
member 222 to present the interchangeable working tips 130 in an
orientation for easy attachment to the shaft.
[0125] FIG. 29 shows a variation of the modular laparoscopy tool
100 where a magnet 224 will be placed around the shaft 102 and will
attract the tip 130 (also magnetizeable) with the right alignment
relative to the shaft 102. After the connection is made, the magnet
224 is optionally taken away. Alternatively, an electromagnet may
be used that can be deactivated to stop attracting the tip 130
after engagement of the tip 130 with the shaft 102. Tip 130 is
shown in an abdominal wall A.
[0126] FIGS. 30-35 show perspective views of a tool tip cassette
140 that can be used with the modular laparoscopy tool of the
present invention. The tool tip cassette 140 is preferably sized
and configured so that it can be delivered through a NOTES tool,
such as the working channel of an endoscope or the lumen of an
endoscope overtube, or alternatively through a laparoscopic cannula
or directly through the wall of an internal organ such as the wall
of the vagina. The tool tip cassette 140 has a plurality of
individual tool carriers 142 that are each pivotally mounted inside
of a capsule 144. Preferably, the capsules 144 are linked together
by hinges 146 or other flexible connections so that it can be
delivered through a NOTES tool that takes a curved or tortuous path
through a body lumen to the surgical site. The hinges 146 or
flexible connections also allow the tool tip cassette 140 to nestle
into a compact configuration within the body cavity adjacent to the
surgical site. Alternatively, if a relatively straight introduction
path can be assured, the tool tip cassette 140 can be made in a
rigid, straight configuration.
[0127] Each tool carrier 142 holds a working tip 130 for the
modular laparoscopy tool. The working tips 130, which are shown
generically, can be configured to emulate any instrument currently
used in standard laparoscopy. In FIG. 30, the working tips 130 are
shown being inserted into the tool carriers 142 in preparation for
use. A combination of working tips 130 may be selected for a
specific surgical procedure or generic tool kits with the most
commonly used working tips can be provided.
[0128] In a delivery configuration shown in FIG. 31, the tool
carriers 142 are rotated so that the working tips 130 are
substantially contained within the capsules 144 to minimize the
delivery profile for insertion through a NOTES tool and to protect
the tools during transit.
[0129] Once the tool tip cassette 140 has been inserted through a
NOTES tool, the tool carriers 142 rotate to present the working
tips 130 for use, as shown in FIG. 32. Optionally, the tool
carriers 142 may be spring loaded so that they rotate into the
presentation configuration automatically upon exiting the lumen of
the NOTES tool. Alternatively, a different mechanism may be used to
rotate the tool carriers 142, either one at a time or all at once.
The tool tip cassette 140 is preferably configured so that the tool
carriers 142 will rotate back to the delivery configuration
automatically when the tool tip cassette 140 is withdrawn into the
lumen of the NOTES tool. Alternatively, a mechanism selectively
actuated by the operator may be used to rotate the tool carriers
142 back to the delivery configuration. Optionally, the tips will
have a funnel structure around the connection point with the shaft,
so that the shaft will be "taken" to the connection point
accurately even if it introduced from different angles.
[0130] When the tool carriers 142 are in the presentation
configuration, the proximal ends of the working tips 130 are
presented for alignment with and attachment to the laparoscopy tool
shaft 102, as shown in FIG. 33. This greatly simplifies attachment
of the working tips 130 to the laparoscopy tool shaft 102. The
distal end of the laparoscopy tool shaft 102 is inserted into the
proximal end of the selected working tip 130, as shown in FIG. 34,
and the working tip 130 is removed from the tool carrier, as shown
in FIG. 35. When the surgeon is finished with a particular working
tip 130, it can be returned to the tool carrier 144 and another
working tip 130 can be selected. When the surgery is completed, or
when the working tips 130 are no longer needed, the tool tip
cassette 140 is withdrawn through the lumen of the NOTES tool.
[0131] In an alternative embodiment of the modular laparoscopy
tools of the present invention, the small diameter shaft may be
replaced by two, three or more even smaller diameter shafts, which
are preferably 1 mm in diameter or smaller. The plurality of
smaller diameter shafts will penetrate the patient's skin through
separate punctures, which may be formed using a needle or the
shafts themselves, and will attach to a working tip that is
inserted through the lumen of a NOTES tool or other channel.
Preferably, the proximal ends of the plurality of smaller diameter
shafts will be attached to a single handle outside of the patient's
body so that they can be manipulated as if they were a single
larger-diameter shaft. Together, the combined shafts will provide
as much support and control for the working tip as would a single
larger-diameter shaft. The smaller diameter of the shafts will
assure that there is even less trauma to the patient from insertion
of the tool. Optionally, relative motion of the plurality of shafts
(translation and/or rotation) can be used to provide control
actuation for the working tip.
[0132] In one optional embodiment of the modular laparoscopy tools
of the present invention, the attachment mechanism for connecting
the working tip to the shaft (or shafts) is constructed so that,
when the shaft is pushed a first time into the tip, it attaches the
shaft to the tip, and, when the shaft is pushed a second time, it
detaches the shaft from the tip. The attachment mechanism may be
configured to require a force for attachment and detachment that is
above a threshold for normal surgical manipulations of the tool.
The attachment mechanism may be located in the shaft or, more
preferably, in the tip.
[0133] Many different tools are currently used in laparoscopic
surgery, any of which can be readily adapted for use with the
modular laparoscopy tools of the present invention. A fairly
comprehensive list of instruments currently used in laparoscopic
surgery is provided below in Table 1. Any of these instruments can
be used as the basis for a working tip configured for attachment to
the shaft of the modular laparoscopy tool. Other surgical tools, as
well as instruments developed in the future, can also be adapted
for use with the modular laparoscopy tools of the present
invention.
[0134] Some specific examples include a surgical tool tip that
includes a suction and/or irrigation tube that extends through a
natural body orifice and/or the internal lumen of the NOTES
delivery tube to the surgical site. The distal end of the
suction/irrigation tube can be held by or attached to a modular
laparoscopy tool to control the location, direction and flow rate
of suction and/or irrigation through the tube. One or more
illumination devices, such as LED, incandescent or fluorescent
lights, or optical fibers, can be delivered through the NOTES
delivery tube and positioned at various places within or around the
surgical site for effective illumination using a modular
laparoscopy tool. One or more cameras, video cameras or other
imaging devices can be delivered through the NOTES delivery tube
and positioned at various places within or around the surgical site
for effective imaging of the surgical site using a modular
laparoscopy tool. The illumination and/or imaging devices can be
attached to the walls of the body cavity or set up on legs or other
supports within the body cavity. The illumination and/or imaging
devices can include magnets allowing them to be aimed using a
magnet external to the patient's body. A working tip with a grinder
or morcellator can be used to reduce the size of an excised organ
or tissue for easy removal through the NOTES tool or a laparoscopic
tool. A working tip can have electrodes for ablation or
electrophysiology measurements.
TABLE-US-00001 TABLE 1 Instruments used in laparoscopy Category
Examples Needle Drivers Scissors Curved Scissors Round Tip Scissors
Potts Scissors Scalpels Graspers Cadiere Forceps Tenaculum Forceps
Cobra Grasper DeBakey Forceps Double Fenestrated Grasper Resano
Forceps Thoracic Grasper Grasping Retractor Monopolar Cautery
Monopolar Curved Scissors Instruments Cautery Hook Cautery Spatula
Bipolar Cautery Maryland Bipolar Forceps Instruments PK Dissecting
Forceps (Gyrus/ACMI/Olympus) Fenestrated Bipolar Forceps LigaSure
(ValleyLab/Covidien) Ultrasonic Energy Harmonic Curved Shears
(Ethicon) Instruments Closure/Clip Hem-o-lok Clip Applier (Weck)
Appliers EndoClip (Autosuture/Covidien) EndoStitch
(Autosuture/Covidien) Anastomosis EEA (End-to-End
Anastomosis/circular Devices stapler) GIA Gastrointestinal
Anastomosis/linear stapler) Specialty/Misc Atrial Retractor
Instruments Valve Hook Pericardial dissector Dual Blade Retractor
Mesh Tacking Device Suction/Irrigation Instrument Specimen
Retrieval Instrument (bag) Implant Delivery Device/system Rigid
endoscope (and camera)
[0135] Various robotic surgical systems have been developed that
are usable for robotic assisted laparoscopic surgery. Examples of
such robotic surgical systems include the DA VINCI Surgical System,
available from Intuitive Surgical, Inc. and the ZEUS Robotic
Surgical System previously available from Computer Motion Inc. All
of the published patents and patent applications of these two
companies are herby incorporated by reference. While these systems
represent a tremendous technological advance in the area of robotic
assisted surgery, they suffer from some of the same drawbacks as
standard laparoscopic surgery. In particular, robotic assisted
laparoscopic surgery still requires 1-2 cm incisions for insertion
of the instruments, as does standard laparoscopic surgery. This is
a great improvement over open surgery, but it still requires some
convalescence time for the patients and carries some risk of
herniation at the incision site. Further miniaturization of
laparoscopic tools has been attempted, but the resulting tools
proved to be too fragile and limited in their use. It would be
beneficial therefore to the patients as well as the surgeons to
provide a robotic surgical system that minimizes the invasiveness
of the surgery while simultaneously improving the effectiveness of
the robotic laparoscopic tools used. This can be accomplished by
utilizing modular robotic laparoscopy tools with very thin shafts
to minimize the puncture size needed to insert the tools through
the abdominal wall and using an endoscope working channel or an
overtube inserted using NOTES techniques as a conduit to deliver
larger diameter end effectors of the modular robotic laparoscopy
tools that will attach to the shaft or shafts inside the body.
Alternatively, a single larger laparoscopic cannula can be used to
deliver the larger diameter end effectors of the modular robotic
laparoscopy tools to the surgical site. Optionally, the endoscope
or NOTES tool and/or the end effector delivery system may also be
robotically controlled.
[0136] FIG. 36 illustrates an example of the improved apparatus and
methods of the present invention adapted for robotic assisted
hybrid endoscopic and laparoscopic surgery. One or more modular
robotic laparoscopic tools 100 are operated using a robotic
surgical system 300. The working tips 130, with robotically
operated end effectors 160, of the modular robotic laparoscopy
tools are preferably delivered to the surgical site through an
endoscope working channel or an overtube 120 inserted through a
natural body orifice using NOTES techniques. Optionally, the
overtube 120 may be inserted into the patient's body through a
natural orifice and advanced to the surgical site mounted
concentrically over a flexible endoscope. The surgical site may be
located in the thoracic or abdominal cavity or within an organ of
the patient's body. Once the overtube 120 is in position at the
surgical site, the flexible endoscope is preferably withdrawn.
Alternatively, a single larger laparoscopic cannula can be used to
deliver the end effectors to the surgical site. Optionally, the
endoscope or overtube 120 may also be used in other ways to assist
in the surgery using NOTES techniques, for example for evacuation
of tissue or organs that were retrieved during the surgery.
[0137] FIG. 37 illustrates an example of a prior art robotic end
effector 302 for laparoscopic surgery. In use, the proximal end 304
of the end effector 302 is attached to a robotic arm of a robotic
surgical system and the end effector 302 is operated by the robotic
surgical system 300.
[0138] FIGS. 38-39 illustrate an example of a modular robotic
laparoscopic tool 100 adapted for use in the improved apparatus and
methods for robotic assisted hybrid endoscopic and laparoscopic
surgery of the present invention. The modular robotic laparoscopic
tool 100 has an end effector 160 component that is configured as a
detachable working tip 130 with means for connection to a modular
robotic laparoscopic tool shaft 102. Preferably, the shaft of the
tool has a diameter of approximately 1-5 mm. The detachable working
tip 130 with the end effector 160, which may have a significantly
larger diameter than the shaft 102, is preferably delivered to the
surgical site through an endoscope working channel or an overtube
inserted through a natural body orifice using NOTES techniques and
attached to the distal end of the shaft 102 inside of the patient's
body. Any of the modular laparoscopic tools described herein can be
adapted to operate as a robotic end effector.
[0139] The end effector 160 on the detachable working tip 130 may
be operated directly though the shaft 102 of the modular robotic
laparoscopic tool 100 by the robotic surgical system similarly to
the prior art end effector 302 described above. For example, pull
wires, pushrods, rotating shafts and/or pneumatic or hydraulic
channels in the shaft 102 may be used to operate the end effector
160. Alternatively, the end effector 160 may be operated remotely
in a master/slave relationship with the robotic surgical system or
a separate robotic controller. Motors or other actuators may be
included in the detachable working tip 130. Control signals may be
sent to the end effector 160 through the shaft 102, or through an
umbilical cable that extends though the NOTES access channel or
through or alongside the shaft 102. Control signals may be sent to
the end effector using wireless technology, for example using
radio, optical, magnetic, sonic and/or ultrasonic control signals.
Power to operate the end effector 160 may be supplied through the
device shaft 102, through an umbilical cable or from a battery or
other power source on board the detachable working tip 130.
[0140] In this invention, a robotically controlled shaft 102 whose
position and movement in space is controlled by a computer via a
master slave system, will be connected to a tip 130 that is
delivered in a separate or different port or conduit. After the
connection, the computer may also control the actuation of the tip
130 which, as long as it is connected to the shaft 102, may move in
space with the shaft 102. The operator may work on a separate
working station where he or she will move a master unit and the
unit that will control the shaft's position and motion will be
controlled by a robotic slave unit. The slave unit may also control
the spacial position of the tip 130 as well as actuation of the
active part of the tip.
[0141] Unlike a traditional robotic tool where the shaft is always
connected to the tip, in this invention the shaft 102 is not always
connected to the tip 130.
[0142] In one option, the tip 130 may include actuation means
inside, like motors, and the master unit's activity will be
translated to electric signals that will actuate the tip to do what
the operator is doing in the working station.
[0143] The robotic shaft 102 may have one or more bendable parts so
that the shaft's distal part can be directed to the side and in
such a way direct the tip in a specific direction after the
connection of the tip to the shaft.
[0144] The following describes optional features that may be
utilized in the implementation of the modular laparoscopy tools of
the present invention.
[0145] Optionally, the modular laparoscopic tool 100 may include an
indicator light or type of other indicator to show when the working
tip 130 has been correctly connected to the tool shaft 102.
[0146] The NOTES instrument can be a flexible endoscope. Each
laparoscopic instrument consists of a "shaft" which can mate to or
release a "tip" or tool at the distal end. The scope may or may not
be provided with an "overtube". If the scope is provided with an
overtube then, after the scope has been properly positioned near
the surgical site, the scope can be withdrawn, while the overtube
is left in place, allowing use of the full working diameter of the
overtube to deliver tips too large to pass through conventional
scope working-channels. The scope or overtube may or may not be
provided at its distal (working) end with a "docking
station"--which may consist of nothing more than a ring or
latch--to catch the tip as it is delivered through a
working-channel or overtube. A tip can be visualized as contained
within a (roughly) cylindrical volume with two "ends". The distal,
or working end, or the tip is the part in closest proximity to the
tissue during a surgical procedure. The distal end of the tip is
oriented toward the distal (working) end of the scope during
passage along the scope working channel. The proximal (mating) end
of the tip will typically have some type of means to releasably
mate with the laparoscope shaft and in many cases will also have
means to transmit mechanical, electrical, RF, pneumatic, hydraulic,
or optical energy required to actuate the tip or to perform
electrocautery and/or transmit or return signals conveying
information such as (but not restricted to): (i) an image of the
surgical site, (ii) haptic information from a force-torque sensor
integrated into the tip, (iii) signals to control the state of the
tip, such as whether grasper position is locked, to actuate any
mechanism required to engage or disengage the tip from the docking
station or shaft.
[0147] The rationale behind Laparoscopic surgical techniques is to
avoid the trauma associated with open surgery. Rigid shafts are
used to manipulate micro-surgical instruments inserted through very
small incisions. Because the shafts are rigid the surgeon has
precise control over their movement and is also provided haptic
sense or "feel" of the mechanical characteristics of the tissue.
Incision lengths of 5-10 mm, however, do not allow the use of many
important surgical tools, which are simply too big to pass through
such a small incision.
[0148] One response to this has been to introduce "Natural-Orifice
Transluminal Endoscopic Surgery" or NOTES. NOTES procedures utilize
a surgical robot or "scope" derived from endoscope technology, to
deliver surgical tools to the site via one of the "natural
orifices" of the human body: trachea, esphogus, anus, vagina, or
umbilical closure. The surgeon controls such an instrument via a
joystick-type interface while observing a video image provided by a
small camera built into the distal end of the scope. Tools are
passed through one or two "working channels". While NOTES allows
the use of larger surgical tools, the scopes are insufficiently
rigid to hold position against typical reaction forces and torques
generated by surgery, no haptic sensory feedback is available to
the surgeon, and the control interface is confusing to those
skilled in laparoscopic procedure.
[0149] The present invention proposes a better, hybrid, approach,
incorporating the following elements: (i) a laparoscope shaft which
can engage and disengage from any tool, making it possible to
insert the shaft alone, sans tool, through a very small incision,
(ii) a set of modular tools, each of which can pass through a
NOTES-scope working channel or overtube as well as mate with the
laparoscope shaft, (iii) various means of providing energy to the
tool to perform the task for which it is intended and (iv) various
means to exchange control signals or information, such as video
information or data from haptic sensors, with the tool.
[0150] A NOTES endoscope is inserted prior to the surgery or in the
first stage of the surgery and manipulated so that the distal end
of the scope is in proximity to the intended surgical target site.
Independently of the scope, incisions for the laparoscopic shafts
are made and the shafts inserted. The first tool is selected and
delivered, mating-end first, to the distal end of the scope. The
surgeon manipulates the shaft tip into contact and mates shaft and
tool, the tool is released from the scope and brought to the
surgical site, the current step in the surgical procedure is
performed, the tool is returned to the scope, the tool is withdrawn
from the body via the scope working channels, the tool required for
the next step in the surgical procedure is selected and delivered
to the distal end of the scope to repeat the process.
[0151] In some cases it may be desirable to use a scope fitted with
an "overtube". After the tube is inserted and manipulated to reach
the surgical site, the scope alone may be withdrawn, leaving the
overtube in place. In this case, tools can be inserted and removed
via the (larger-diameter) overtube.
[0152] A wide variety of modular tools are possible: Staplers are
one of several tools too large to pass through a laparoscopic
incision which can, however, pass through a working channel or
overtube, and can therefore be used with the proposed approach.
[0153] Some additional possibilities suggested by the modular MIS
concept:
[0154] In the present invention, the scope or the tube serves two
primary functions of: (i) delivery of the tip to the shaft and (ii)
retrieval and/or exchange of the tip at the completion of the
surgical phase requiring this tip. In addition, the scope,
otherwise idle during the surgical procedure after delivery of tip
to shaft, may also serve to hold a fixture to facilitate some
surgical step, such as knot tying or suturing. See, for example,
the publication from Dartmouth entitled "Knot tying with single
piece fixtures". Such a fixture might be permanently inter-grated
into the docking-station to be available at all times during
surgery.
[0155] Use of scope to support a fixture: After transfer of the tip
tool to the laparoscope shaft the scope is free to perform other
functions during surgery. For example, one or more fixtures can be
provided at the distal end of the scope, such as a fixture to
assist with knot tying or other procedures.
[0156] The scope can also be used to carry one or more fixtures to
assist with a surgical procedure or to make possible a procedure
which would otherwise be impossible using only two shaft-mounted
tools, such as knot-tying. Such fixtures can be permanently
attached to the scope or (alternatively) might be made "tool-like",
so that the fixture could pass through a scope working channel or
the overtube to attach and be retained at the end of the scope only
for the duration of the particular surgical step for which it is
needed. Such a fixture can also carry movable mechanical elements
requiring any of the various type of actuation considered above.
Since the fixture will remain attached to the scope during the
procedure, it is not necessary, in this case, to provide
disengageable connectors at the fixture itself.
[0157] Use of scope to carry an additional tool. After a tip has
been passed to the shaft, a new tool can be extended to the scope
distal end to participate in the surgical procedure or act as a
"third-hand". In some cases this may allow use of only a single
shaft (and single incision) for the procedure.
[0158] Idle Scope can Hold a Second Tool
[0159] An oft-stated limitation of NOTES is that the two working
channels provided by the scope are separated by only a small
distance, hindering simultaneous use of two instruments 1 Perhaps
it should be mentioned that, in addition to serving a "third hand"
to hold a fixture or some other device in proximity to the surgical
site, the scope can also serve to hold a second tool, for example,
a clamp to fix tissue in place while the surgeon performs a
procedure requiring fine motor control using a tool transferred to
one or the other laparoscopic shafts.
[0160] Coordinated activity of scope and laparoscopic tool: In
cases where the scope is not idle, and participates in one of the
above ways during surgery, means may be provided to sense the
position and orientation of the shafts and a software component
provided to control the scope in such as way that motion of the
scope automatically follows surgeon-controlled motion of the
shafts. Different scope motions will be required for different
scope tasks. For example, if the scope is providing a stereo view
of the surgical site, the scope may have to automatically orient to
image one or both shaft tips, and motion compensation software may
be incorporated to compensate for patient motion or vibration. If
the scope is acting as a "third hand", software to "actively
stiffen" the scope may be required.
[0161] To simplify the "docking" maneuvers required to orient and
align tip to shaft prior to attachment or detachment of the tip to
shaft, a "software component" may be utilized to provide automatic
control of the scope while passively monitoring the position and
orientation of the laparoscopic shafts as they are manipulated by
the surgeon. In case simultaneous use of scope- and shaft-mounted
tools is used, such software could also be used to automate scope
positioning or to "stiffen" the scope via active feedback.
[0162] It is also possible to transmit energy and/or information to
the tool via an "umbilical" cord which remains connected to the
scope during the surgical procedure and which may, for example, run
down the second working channel to attach to devices located
outside the patient's body. Use of an umbilical connection of this
type is clearly feasible when the tool is delivered via an
overtube. Use of an umbilical will fully or partially eliminate the
need for any additional attachment or connectors between shaft and
tool, other than the mechanical mating connection.
[0163] One method of delivering tip to the end of a scope working
channel is to thread a cable attached to the tip through the
scope's second working channel and then "pull" the tip to the end
of the primary channel using the thread or cable. This raises the
possibility that cables needed to carry energy and signals required
to actuate and control the tip would also thread through the second
working channel. In this case, after the shaft has attached to the
tip, and the tip has been released from the docking-station, an
"umbilical" consisting of these cables would continue to connect
tip and scope during surgical use of the tool. In this case, it
would not be necessary to provide any additional connection between
shaft and tip, beyond that required to attach and retain the
tip.
[0164] It is also possible to transmit energy and/or information to
the tool via an "umbilical" cord which remains connected to the
scope during the surgical procedure and which may, for example, run
down the second working channel to attach to devices located
outside the patient's body. Use of an umbilical connection of this
type is clearly feasible when the tool is delivered via an
overtube. Use of an umbilical will fully or partially eliminate the
need for any additional attachment or connectors between shaft and
tool, other than the mechanical mating connection.
[0165] Umbilical: electrical and hydraulic cables required to
transmit control or video signals and/or power to actuate the tip
tools can be provided via an umbilical cable, which remains
attached to the scope during the surgical procedure. The shaft need
only carry the means to couple to the tip and retain it during the
surgical procedure. The umbilical cable will pass down one of the
two working channels of the scope (here identified as the secondary
channel). When the tip is retrieved via the primary working
channel, any connectors at the proximal end of the umbilical cable
will be detached to allow the umbilical cable to be pulled back
through the primary working channel behind the tip.
[0166] Navigational aid--In some cases it may be desirable to be
able to track the location of shaft-mounted tips within the body,
perhaps to reference the 3D position of the tip with respect to the
2D image provided by the scope camera, or in reference to the scope
itself. In this case, the scope might be provided with short range
transducers--for example, ultrasonic ranging transducers--which
could be used to determine the location of a shaft-mounted tip
relative to the scope. A software component, monitoring the actual
position of the scope, via Ascension-type magnetic encoders, scope
"shape-sensors" or other means, could the calulate, report and
display the true position of the tip within the body.
[0167] A scope may be fitted with magnetic position and orientation
sensors, allowing the position of the scope within the body to be
tracked (in theory). In this case, it may be desirable to provide
the scope with a laser pointer or similar device to serve as a
"target designator" to mark a point, determined by an MRI or CT
scan, and so guide the surgeon in placement of the shaft-tip
tools.
[0168] The scope can carry ultrasound to continuously monitor the
distance to ultrasound transponders attached near the shaft tips,
allowing continuous tracking of tip motion.
[0169] If the scope is fitted with magnetic induction sensors by
means of which scope position and orientation (or, at least, scope
tip position and orientation) can be determined to high accuracy
with respect to an external coordinate frame. In some cases it may
be desirable to register or calibrate with respect to positional
information referenced to an external frame, such as data obtained
via an MRI or CT scan. In this case, the scope might be used to
relay such information to the surgeon, perhaps via use of a
laser-pointer type device which can be aimed with reference to the
external coordinate frame to designate a particular spot within the
patient's body. The surgeon could then move the laparoscope scope
and shaft-mounted tool with relation to the designated spot.
[0170] It is also possible that the scope could be fitted with some
type of transponder, for example, an ultrasonic transponder, to
continuously monitor the position of the shaft-mounted laparoscope
tools and thus track their position and orientation with respect to
an external reference frame.
[0171] Stereocamera--If an umbilical is not needed, an alternative
use for the temporarily idle scope would be to insert fiberoptic
imaging bundles, each equipped with a GRIN lens, through the scope
working channels, to provide a stereo image of the surgical site.
The imaging-bundle can be withdrawn to remove and replace a tip,
then re-inserted for the next procedure.
[0172] Use of scope for stereoscopic imaging: After transfer of the
tip tool to the laparoscope shaft, the two working channels of a
standard NOTES scope are free. Coherent fiberoptic imaging bundles,
to the distal end of each of which is attached a GRIN or similar
lens, can be inserted into the working channels to deliver a
stereoscopic image of the surgical site during the procedure. The
FO bundles will then be removed following the end of each surgical
step to allow tip exchange.
[0173] The scope may incorporate a camera to provide a video image
of the surgical site. Because the techniques proposed here relieve
the scope of much responsibility during the actual performance of
each step in the surgery, more room is potentially-available at the
distal end of the scope, permitting (for example) incorporation of
a stereo video camera at the scope tip, to provide a stereo video
image of the surgical site.
[0174] Haptic Feedback
[0175] There are complaints that, even in laparoscopic surgery,
friction at the trocar or elsewhere limits the surgeon's haptic
sense--the ability to palpitate and "feel" the tissue. Tools have
been designed to incorporate a variety of "haptic" sensors,
typically a Maltese-cross or hexapod arrangement of strain gages
interfaced to a specialized joystick or similar means to provide
"force-feedback" to the surgeon.
[0176] Haptic feedback: The current proposal for the first time
permits use of large-diameter tools with minimal-incision size.
Surgical tools have been designed to incorporate force-torque
feedback, but such tools are currently much too large to use for
laparoscopic surgery. The "modular minimally-invasive" technique
proposed here will permit such tools to be used and thereby provide
"haptic feedback" to the surgeon, enabling him to palpitate
tissues, etc. Many methods have been devised to report and
"display"--the term includes "tactile display".about.haptic
information to the surgeon. This may involve specialized regions at
the proximal end of the shaft, in contact with the surgeon's hands
during the procedure, such as tactile display pads or other
means.
[0177] Tool and/or fixture fabrication process: Conventional MEMs
processing, such as (i) bulk silicon or (ii) surface micromachining
is currently incapable of realizing mechanical elements capable of
delivering forces >1 N and torques on the order of several 100
N-mm. It is most likely that micro-fabrication techniques such as
(i) LIGA, (ii) EFAB (Microfabrica), or (iii) multi-layer
micro-stereolithography (EoPlex) will be required.
[0178] Despite impressive progress in the fabrication of
micro-mechanical parts midway between MEMs microdevices and
conventionally (micro-) machined parts, tools with integrated
haptic feedback and/or wrist mechanisms are likely to remain too
large to pass a 5 mm incision. A primary benefit of this proposal
is to make it possible to use such tool tips in conjunction with
the familiar rigid laparoscope shaft.
[0179] It is anticipated that, to support the use of tools with
integrated haptic-feedback sensors, or with wrist mechanisms
providing additional degrees-of-freedom, some modifications to the
proximal end of the shaft will be required, to provide haptic
feedback to the surgeon's hands (controlling the shaft) or a wheel
or thumb-operated element to control wrist orientation.
[0180] TrEndo (Lieden University) is one system designed to provide
haptic feedback during laparoscopic procedures.
BenHani et al (Rennselaer Polytechnic) "Plug and play tool handles
for laparoscopic surgery simulations" is another.
[0181] This University of British Columbia course by Sideny Fels
provides a good overview of haptic interfaces.
[0182] Consideration re Tip-Shaft Coupling and Tip Mechanism
Actuation
[0183] Mechanical Design Issues
[0184] Shaft Design
[0185] The shaft has to have sufficient rigidity to support the tip
against reaction forces and torques generated by the surgical
procedures. Since the flexural rigidity of a shaft increases with
the fourth-power of the diameter, it is likely that the shaft will
be a cylindrical tube surrounding and enclosing any additional
mechanical elements, cables, etc, required to communicate with or
actuate the tip mechanism
[0186] If mechanical means are used to actuate the tip (no motors
involved) then this might be accomplished by rods sliding within
the shaft and pushing or pulling on elements in the tip, or it
might involve rotation of rods within the shaft, engaging and
rotating elements in the tip.
[0187] The present invention may optionally use of micro-motors,
hydraulic or pneumatic mechanisms, and/or mechanical transmission
from shaft to tip. For example, cable-driven mechanisms and/or
four-bar mechanisms may be used.
[0188] When tool function involves relative motion of tool
elements--such as the motion of one grasper or clamp jaw against
another--this mechanical motion can be supplied in many different
ways, for example, directly via (i) any combination of rotational
and/or translational motion across the interface between shaft and
tool, such as involving a shaft rod pushing on a tool element, or a
shaft rack gear engaging a tool pinion gear (or vice versa), or a
shaft miter gear engaging a tool bevel gear, or a shaft pinion gear
engaging a tool internal gear (or vice versa).
[0189] One thing regarding the Faulhaber and other DC micro-motors
(below) is that they incorporate micro-fabricated gearboxes. If the
tip can contain such a gear mechanism, it may be unnecessary to
also have a motor. The shaft may contain rods with micro-bevel
gears or splines cut into the end which slide into and engage gears
at the tip. Or a rod may have a rack gear cut into the distal
portion of the rod, which engages a pinion gear at the tip. In this
case, sliding the actuator rod relative to shaft and tip will
rotate the pinion gear to actuate the tip mechanism. Or the rod can
have a worm gear cut into the distal end, which engages a spur gear
at the tip. In this case, the rod worm gear can be threaded into
the tip gear after shaft-tip mating.
[0190] A second point is that motors usually consist of an
element--the "rotor"--which rotates within a fixed "stator". Now
the rotor and stator can be separated. If the stator carries the
magnetic field coils, it might be attached to the shaft, while the
rotor--which might contain permanent magnets, etc--is part of the
tip. During assembly, the stator will slip over the rotor. No
electrical connections are required to the tip in this case. Power
transmission occurs via magnetic-field coupling from shaft-stator
to tip-rotor.
[0191] Common shaft drive, multiple tip functions: A gear--for
example, an internal or external gear machined into a rod contained
within the shaft--can engage multiple gear mechanisms within the
tip. If each tip gear is provided with a selectively-actuated
clutch mechanism (for example, an electro-magnetic clutch) then it
becomes possible to selectively activate one or another mechanical
element of the tip and thus perform any of a number of mechanical
functions using a common drive rod.
[0192] Or mechanical action can be generated using electromagnetic
means, such as a DC motor, stepping-motor, or variable-reluctance
motor. In this case, it is not necessary that the motor be entirely
contained within the tip. Motors consist of a stationary element
(the "stator") and a rotational element (the "rotor"). The rotor
might be part of the tool and slip into a shaft-mounted stator
element, containing the electrical drive coils, at the time tool
and shaft are mated. In this, energy passes from shaft to tip via
the magnetic fields created in the rotor-stator gap. The same
principles apply to DC motors, stepping-motors with
permanent-magnet as well as variable-reluctance rotors, and similar
devices.
[0193] Shaft-to-tip power transmission: Motors of all types
typically consist of a moving element--for example, the rotor of a
DC motor--and a stationary element, such as the stator of a DC
motor. In some cases these elements are in close proximity but not
in mechanical contact. In such cases, power is transmitted from one
element to the other via magnetic or electrostatic fields. In other
cases, such as the "inch-worm" motor, the stationary element may
contain clamps or other mechanisms which briefly attach to and
exert mechanical force on the movable element. We note that the
movable member of either of these types of motor may be contained
within the tip, while the stationary member of the motor is
contained within the shaft (or vice versa). For example, the stator
and coil assembly of a microminiature motor can be part of the
shaft while the rotor is part of the tip. These elements will be
arranged so that, when tip and shaft are mated, the stator is
concentric with the rotor and in the correct position for
electromagnetic fields to act on the rotor to exert torque on
elements of the tip. A similar type of arrangement would allow
"inch-worm" type pizeoelectric elements in the shaft to drive a
rotating disk which is part of the tip.
[0194] It is also possible to transmit mechanical work via friction
between two parts in contact. The piezoelectric "inch-worm" motor
uses this principle. An inch-worm mechanism can be used to transmit
force or torque from shaft to tool, if the tool contains a movable
part engaged by an inch-worm like clamping mechanism attached to
the shaft. The movable part can be a disk, to transmit rotational
motion, or a shaft (as in the SQUIGGLE motor, New Scale
Technologies, Inc.). Piezoelectric "wave" motors utilize the same
principle and can be applied here in a corresponding manner.
[0195] "Inch-worm" type mechanisms containing textured or otherwise
specialized contact elements can deliver greater force. These are
sometimes referred to as "meso-scale" actuators.
[0196] For example, wire stubs attached to movable elements of the
tip can protrude from the mating surface of the tip. Individual
piezoelectric "inch-worm" clamp mechanisms can be provided within
the shaft for each tip stub. When tip and shaft mate each tip stub
will insert within it's corresponding clamp mechanism. Once mated,
electrical connections within the shaft extending to each clamp
mechanism allows the generation of an axial tension or push on the
corresponding tip stub wire. The stub wires may simply attach to
movable elements of the tip, or to a flexure mechanism to amplify
stub wire displacement or force. The tip mechanism is simple and
inexpensive while most of the complexity and cost reside within the
shaft.
[0197] Inductive coupling: To eliminate the need for electrical
contacts between shaft and tip, induction coils on the shaft and
tip can be used to transmit electrical power from shaft to tip as
well as to transmit and receive control signals.
[0198] Shaft-to-tip power transmission, rotational, key or spline:
The shaft carries one or more control rods. Micro-machined into the
end of each rod is a key or spline which can engage with a mating
surface within a rotational element of the tip. These rods pass
through bushings in the shaft which align each rod with the
appropriate rotational element of the tip when tip and shaft are
mated. Rotation of a control rod will then actuate a particular
element of the tip.
[0199] Shaft-to-tip power transmission, rotational, bevel or miter
gear. As above, except that the each rod carries a miter gear at
the distal end, which mates with a 90 deg bevel gear, to transmit
shaft rotation to elements within the tip.
[0200] Shaft-to-tip power transmission, rotational, worm gear. As
above, except that each rod carries a worm gear at the distal end,
which threads into a mates with a helical gear within the tip.
Rotation of the rod will again transfer torque to an element of the
tip.
[0201] Shaft-to-tip power transmission, translational, rack. As
before, except that in this case, the distal end of each rod
carries a rack gear which engages a pinion gear in the tip when tip
and shaft are aligned and the rod is extended. In this case,
translational motion of the rod will cause rotation of the tip
pinion to actuate a tool or catch.
[0202] Shaft-to-tip power transmission, wobble-plate. In this case,
three rods are provided within the shaft which pass through
bearings spaced at 120 deg intervals and equidistant from the axis
of a "wobble-plate" or eccentrically mounted disk within the tip.
Extending and/or retracting the rods in the proper sequence will
then cause clockwise or counterclockwise motion of the wobble
plate.
[0203] Wobble-plate, hydraulic actuation: As above, except that,
instead of rods extending the length of the shaft, three hydraulic
cylinders at the distal end of the shaft apply force to rotate the
wobble-plate.
[0204] Another type of mechanism to transmit mechanical motion from
shaft to tip is the "wobble-plate" motor. An offset disk, rotating
(or driving) a shaft in the tool, is acted upon by three shaft
push-rods passing through bushings spaced at 120 degree intervals
with respect to the rotational axis. Extending or retracting the
shafts in the appropriate sequence will cause the disk to rotate
clockwise or counterclockwise, as desired. This mechanism is
commonly-used in piston-type hydraulic motors. The mechanism is
simple and requires no attachment--the push rods would simply slide
into guide bushings in the tip at the time of mating.
[0205] Finally, a very interesting class of motors are those which
involve friction drive. The inch-worm is a well-known example.
These operate using two (typically piezoelectric) clamps which are
actuated in alternation. Now in this case the movable
portion--which can be a rod or a disk--can be attached to the tip,
while the expensive clamp mechanism can be attached to the shaft.
Piezomotors used for camera focusing are a variant on this design,
using a "wave" or harmonic-drive mechanism. More information is
provided below.
[0206] It may also be useful to note that there are now a number of
references to "mesoscale actuator devices" (MAD), which appear to
be inch-worm mechanisms, adapted to provide high forces and torques
via micro-machined grooves or serrations: 100 pound drive forces
have been achieved!
[0207] "Mesoscale actuator devices": Inch-worm or friction drives
typically involve mating elements which are smooth. Surface
textures can be applied to the mating surfaces to increase
actuation forces or torques obtainable. Such devices are sometimes
designated "mesoscale actuators".
[0208] Docking Station
[0209] To retain the tool upon delivery to the distal end of a
scope or a NOTES delivery tube, a "docking station" may be
incorporated into the design or attached to the distal end of the
scope or tube. The functions of this docking station will be to (i)
"catch" the tool as it is delivered through a scope working
channel, (ii) to support any pulley or cable mechanism, involving
joint use of two scope working channels, (iii) to hold the tool in
place during alignment and mating, (iv) to (controllably) release
the tool, or capture it when it is released back to the scope after
use. The docking station may also incorporate functions to
rotationally-index the tool and so orient it correctly for pick-up
by the shaft. Also to hold the docking station may include a
mechanism for holding it in a stable position within the surgical
site. For example, a mechanism can affix the cassette within the
abdominal cavity so that it provides a stable tray for the tools
and does not flip over when it lays over the small intestine or
other organs. There could be a mechanism that can open and close
and function as support legs or like a wire base. The docking
station could also be attached along the side, for example on
internal abdominal wall, etc.
[0210] Docking module: A specialized region or attachment to the
scope or tube may be provided which will serve one or more of the
following functions: (i) "catch" the tip when it is delivered
through the scope working channel, (ii) rotationally index the tip,
(iii) provide an elastic or releasable detent to affix the tip to
the docking module, (iv) to retain the tip and resist forces
generated during the process of aligning and mating to the shaft,
(v) (controllably or passively) release the tip to the shaft, as
well as any or all of these operations, performed in reverse. If
controllable latches or release mechanisms are required, any of a
variety of means may be provided, such as an electrical solenoid
latching element, a hydraulic or pneumatic latch or clamp, etc.
[0211] While this may not be necessary, it seems likely that some
type of specialized fixture, located at the distal end of the scope
or tube, is likely to be required (or at least helpful) to: (i)
catch the tip when it arrives at the end of a working channel or
overtube during the "tip delivery" phase, (ii) retain the tip while
the laparoscope and/or scope are manipulated to orient and align
tip and shaft prior to mating, (iii) to hold the tip somewhat
firmly in place during contact and mating of shaft and tip, (iv) to
hold the tip when it is returned from the shaft to the scope and to
(v) retain the tip while during and after its release from the
shaft.
[0212] Since scopes are expected to be available from a number of
manufacturers, it may or may not be desirable to either (i) license
the docking station design to scope vendors or (ii) provide a small
module which can be mounted to any of a number of existing scopes,
adapting them to use this new technology.
[0213] The docking station may or may not also provide means, such
as an electrical connector, to mate with the similar means,
attached to the shaft, to supply energy or transmit control signals
between shaft and tip. In case the docking station is to be
installed at the tip of the overtube, this might be arranged via an
expanding ring mechanism, possibly actuated pneumatically, which
will expand against the interior surface of the overtube, thus
locking the docking station in place. The docking station might
have transparent regions to allow use of a scope camera and
illumination system during surgical placement of the scope.
[0214] Mating connector--For example, the tool may present a pin to
engage and be retained by a collet-clamp affixed to the end of the
laparoscope shaft. The collet may provide a clamp-and-release
mechanism, or (alternatively) an undersized elastic collet can
retain the pin via elastic clamping forces after it is pushed into
engagement.
[0215] If a threaded coupling is used to attach tip to shaft, then
it may be important to choose either a left- or right-hand thread,
so that reaction torques don't cause the tip to unscrew from the
shaft.
[0216] A very wide variety of other mechanisms can be used to
attach tip to shaft. For example, a pin might protrude from the
mating end of the tip while the shaft end will carry a chuck or
collet. During the mating operation, the shaft is manipulated to
(i) align or make parallel the axes of pin and collet, (ii) offset
tip and/or shaft into the axes are coincident, (iii) advance the
collet to engage the pin. An elastic collet, slightly smaller in
diameter than the pin, will expand slightly to retain the pin (and
tip) after the tip is withdrawn from the docking-station. Or it may
be desirable to equip the collet with a latch-and-release
mechanism, controlled by the surgeon.
[0217] If the pin is hollow, the pin lumen might be used to
transfer pneumatic pressure from shaft to tip to energize or
actuate graspers or scissors. For example, the tip could utilize a
micro-miniature electroformed bellows, attached to and terminating
the pin channel.
[0218] Application of pressure to a port at the proximal end of the
shaft will than cause the bellows to expand and extend, thus
applying force to mechanical elements within the tip tool and
thereby actuating graspers or scissors. Spring return, or suction
applied to the proximal end of the shaft, would then cause the
bellows to contract and return the tool to its initial state.
[0219] Mating connector (pin-and-socket): A pin may protrude from
the mating surface of the tip. The shaft will carry a collet
mechanism of approximately the same inside diameter as the outside
diameter of the tip pin. During tip transfer the surgeon will
orient and align the collet axis with the pin axis, advance the
shaft to move the collet over the pin, and then engage the collet
clamping mechanism, thereby retaining the pin and allowing the tip
to be removed from the scope working channel. The process will be
reversed when the tip is returned to the scope working channel for
exchange.
[0220] The internal diameter of the collet can be slightly
undersize and the collet mechanism compliant, so that application
of a slight axial force when collet and pin are aligned is
sufficient to push the collet over the pin and afterwards retain
the pin due to the elastic clamping force exerted by the collet. In
this case, no open- and release mechanism is required of the
collet.
[0221] To permit a sufficient amount of slack during the alignment
task, pin or collet may provide a short tapered region, to act as a
guide to bring tip and shaft into more accurate alignment than is
otherwise possible.
[0222] The pin may be hollow, allowing actuation means, such as
push rods to pass through the pin from shaft to tip, thus allowing
the translation or rotation of control rods within the shaft to
exert forces and/or torques on mechanical elements within the
tip--including splined hubs, pinion gears, bevel gears, etc--and
thus actuate tip tools.
[0223] The pin may be hollow and attached to an elastomeric or,
preferable, an electroformed metal bellows within the tip. The
shaft collet will be connected to a hydraulic line. When tip and
shaft are mated, pressurizing this control line will cause the
bellows to expand and exert force on elements within the tip.
[0224] For example, the tool may present a pin to engage and be
retained by a collet-clamp affixed to the end of the laparoscope
shaft. The collet may provide a clamp-and-release mechanism, or
(alternatively) an undersized elastic collet can retain the pin via
elastic clamping forces after it is pushed into engagement.
[0225] Alternatively, the tip may be the female part, while the
shaft male connector expands during the mating process to retain
the tip after release from the docking station.
[0226] If it is not possible to align tip and shaft appropriately
prior to mating, a connector, such as a spherical ball on a stud,
captured by a mating "clamp" on the shaft (or vice versa) may be
required. This type of connector could be engaged by a shaft
approaching from any direction. Whatever type of connector is used,
it is likely to be desirable to provide a tapered "lead-in" region
which will tolerate some degree of initial misalignment and then
"guide" the tip and shaft mating parts into proper alignment for
mating.
[0227] Ball-and-stud coupling. In some situations it may be
difficult to align the tip and tool axes parallel. In this case, in
place of a simple pin, the tip mating surface can be provided with
a ball-and-stud. In place of a collet, the shaft will carry a clamp
designed to mate to and retain the ball. In this case, the shaft
may approach the tip from a wider range of directions. This will
also allow the tip to be mounted at an arbitrary angle, without the
need for a laparoscopic "wrist" mechanism, if it is desirable to
have the tip offset for the surgical procedure.
[0228] Magnetic latching mechanisms: If the shaft is fabricated
from a material with high magnetic permeability and a movable
element within the tip is also of high permeability, bringing a
permanent magnet near or into contact with the proximal end of the
shaft will cause a force to be exerted on the tip element, acting
to bring the tip element into closer proximity or contact with the
shaft element. This method can be used to actuate a tip mechanism
or to engage or disengage a mechanical latching element within the
tip.
[0229] Electro-magnetic latching mechanism: As above, except that a
coil is wound around the proximal end of the shaft. Passing a
current through this coil will induce a magnetic field within the
shaft, which will act in the same was as described above to actuate
the tip element. Micro-miniature electromagnetics may be utilized
for connection and/or actuation of the tip.
[0230] Magnetic fluids: A magnetically-actuated clutch can be
realized using a dispersion of magnetic colloidal particles filling
a gap between two closely-apposed surfaces. A clutch mechanism of
this type, incorporated within the tip tool, can be activated using
the same techniques indicated above.
[0231] If the tip and/or shaft are either (i) manufactured from a
material with high magnetic permeability or (ii) either contains a
miniature magnet (such as a SmCo or NdFeB magnet), magnetic forces
may be used to assist with the retention of the tip to shaft. In
this case, it is possible to provide a "release" mechanism via a
small coil placed at the end of and around the shaft. A
current-pulse through this coil will transiently generate a reverse
magnetic field, allowing tip and shaft to be disengaged. If shaft
and tip are made of a material with high magnetic permeability,
another means to releasable engage and disengage the tip is to
simply move a magnetic into contact with the proximal end of the
shaft, using (for example) a simple mechanical switch or button,
controlled by the surgeon with his thumb. When the magnet is in
contact with the proximal end of the shaft the magnetic field is
carried by the high-permeability shaft to the tip, drawing the tip
into contact with the shaft. In this case it is important that
shaft and tip material have low magnetic retention, so that the
magnetic field vanishes once the magnet is moved away from the
shaft.
[0232] If the shaft is provided with helical external "threads" to
facilitate insertion of the shaft through the incision in the skin,
it is possible that this same threaded region could insert into a
complementary surface of the tip end to attach tip to shaft.
[0233] Another means of capturing and mating tip to shaft may
involve passing a wire to which a Tee-shaped ferrule is attached at
the distal end, along the axis of a (hollow cylindrical) shaft,
inserting it through a slot in the tip, rotating the wire 90
degrees to engage the tip, and then applying tension to the wire to
retain the tip to the end of the shaft. The tip can then be
released after return to the docking-station by reversing the
procedure. While in general it is likely that the mating surfaces
will have conjugate profiles (such as pin-and-hole) there are cases
where the mating surfaces may have identical form (so-called
"hermaphrodite" connectors). It is likely that any collet mechanism
required can be machined into a "one-piece" shaft via EDM or
similar means, to create a notched "flexure" mechanism
[0234] Flexures and compliant mechanisms: In many cases it is
possible to realize rotational and translational elements by means
of one-piece machining of notches to create a so-called "flexure
mechanism", also known as a "compliant mechanism".
[0235] Flexures mechanism, push-rod actuated scissors or graspers:
Flexure mechanisms can be designed with integrated "levers" to
provide substantial amplification of displacement. A flexure-type
scissors or grasper can be fabricated from one piece integral with
the tip and actuated by a single push-rod extended from tip to
shaft to bear on a movable element of the flexure.
[0236] Tip fabrication--Micro-fabricated tools containing a
multiple-degree-of-freedom "wrist" mechanism are available, but
these tools are also much too large to pass through a laparoscopic
incision. Because they are, however, small enough to be delivered
through a scope working channel or overtube, tools with integrated
wrist mechanisms will also be usable with the technique proposed
here.
[0237] Micro-fabricated tools containing force-torque sensors,
capable of providing haptic feedback to the surgeon, are also
possible, but too large to pass through a laparoscopic incision.
Again, this type of tool will be usable in the new approach
proposed here, making it possible for the first time to supplement
the haptic feedback naturally provided by the rigid shaft. In many
cases the haptic sense which, in theory, is provided by use of
rigid laparoscopic tools is limited, due to friction and other
effects arising due to interaction between the shaft and
trocar.
[0238] There are a wide variety of possible mechanisms or elements
by which the tool can reversibly mate with the shaft while also
providing sufficient rigidity to remain stable against the reaction
forces and torques associated with use of the tool. These mating
elements support one or more of the following functions: (i)
"guiding" the mating pieces into good contact (thus relaxing the
precision with which the parts must be oriented and aligned prior
to mating), (ii) a "detent" or catch mechanism, which may be
activated by an independent mechanism to engage or release, or
(alternatively) the catch or detent function may be achieved
passively, through the use of an elastic mechanism, (iii) means by
which mutual motion or rotation of the mating parts is restricted.
For example, insertion of a pin into a matching hole removes four
of the six relative degrees-of-freedom of the two parts, leaving
only free rotation about the axis of the pin and translation
parallel to that axis. Many such kinematic or "semi-kinematic"
constraints can be incorporated into shaft and tool to fix their
relative position during the surgical procedure. In some cases, the
parts are not completely constrained by kinematics: instead,
frictional forces or clamps may be used.
[0239] In other cases, suction may be used to retain tool to
shaft.
[0240] In other cases, a specially-shaped wire rod (for instance,
with a Tee-bar end) can insert into a tool slot or other
specialization to engage the tool, so that tension on the wire
holds the tool in place against the shaft.
[0241] A "detent" mechanism, such as a latch engaging a machined
slot in the pin, can be used to restrict axial motion of a
pin-and-collet mechanism. Such a detent will also provide a
mechanism to retain the parts in contact, after insertion of the
pin into the collet, as well as to allow for the controlled
disengagement of pin-and-collet.
[0242] A cam or wedge action can be used to separate the parts
axially and assist disengagement.
[0243] If it is necessary to attach the tool in a precise position
and orientation with respect to the shaft, a kinematic coupling,
such as a Kelvin coupling, can be used. In this case, a magnetic
field may be used to retain contact between tip and shaft during
the surgical procedure. This may involve use of a tool and shaft
fabricated from a material with high magnetic permeability. In that
case, a magnetic field induced in the shaft by means of a permanent
magnet brought into contact with the proximal end (surgeon's end)
of the shaft, or by means of a coil wound around the proximal end
of the shaft, will cause the tool to be attracted to shaft. The
tool will release when the magnetic field is removed.
[0244] Conventional MEMs fabrication processes are discussed in
many texts5 and are often classified as "surface" or "bulk"
methods. The force and torque available to date from devices
fabricated using either of these processes are much too limited to
actuate microsurgical tools, which require forces on the order of 1
N and torques of 100-300 N-mm. "High aspect ratio" processes such
as LIGA and EFAB have been developed to create micro-mechanisms of
the appropriate scale, mid-way between conventional MEMs devices
and surgical tools fabricated by standard machining and molding
methods.
[0245] Hydraulic mechanisms can provide large forces while also
offering high precision. Micro-fabricated bellows, such as
electroformed bellows mechanisms used in micromanipulators, can be
used to actuate elements within the tool. Hydraulic or pneumatic
pressure can be applied to such a mechanism via a hydraulic
coupling. For example, if a pin-and-collet mechanism is used to
mate tool and shaft, the pin can be hollow, and attach to a bellows
mechanism within the tool. It is then possible to apply hydraulic
pressure to actuate the bellows via a conduit attaching to the
collet and running the length of the shaft. If hydraulic or
pneumatic connection to the tool is provided, multiple hydraulic
mechanisms can be supported with use of micro-miniature hydraulic
valves (which can be actuated electrically, or via magnetic
influence from the shaft).
[0246] Tip tool actuation, hydraulic: Use of an umbilical cable
will allow hydraulic actuators within the tip to be energized,
without requiring hydraulic-disconnect couplings between shaft and
tip. Use of hydraulic actuators permits the generation of large
forces while at the same time allowing very precise movement, as is
well known from experience with hydraulic micropositioners used for
micro-electronics workstations as well as for electrode positioning
in neurobiology.
[0247] Tip tool actuation, hydraulic: Micro-fabricated hydraulic
valves are becoming available which might be integrated into the
tip. In some cases these valves may be magnetically actuated,
allowing use of techniques indicated below to communicate the
magnetic activation force from shaft to tip. Use of multiple
micro-hydraulic valves within the tip allows a single hydraulic or
pneumatic supply line or plenum to selectively activate hydraulic
or pneumatic effectors within the tip.
[0248] Micro-Miniature Piezoelectric Motors
[0249] Most piezoelectric devices manufactured today use
polycrystalline materials such as barium titanate. Also under
development are single-crystal piezoelectric materials which have
greatly improved operating characteristics.
[0250] Seiko is also a major vendor of ultrasonic motors for camera
and cell-phone applications. They market this 4.5 mm.times.2.5 mm
ultrasonic motor. NewScale is manufacturing the SQUIGGLE ultrasonic
linear motor, which can move a 7 mm/sec and generate 30 gm [0.3 N]
force. The motor dimensions are 1.8.times.1.8.times.6 mm. The motor
is used in a Tamron zoom lens.
[0251] Air Lock
[0252] To maintain pressure in the peritoneal cavity during
tool-exchange, it may be desirable to provide some type of air-lock
at the proximal end of the scope. To facilitate rapid exchange of
tips, an air lock may be provided or fitted to the proximal end of
the scope, to prevent the release of pressure within the peritoneal
cavity from occurring during tool exchange.
[0253] Inch-Worm Tip Delivery
[0254] In addition to draw cables and pneumatic delivery
mechanisms, it would also be possible to have an "inch-work" pusher
or "tractor" carry or push the tip to the end of the scope, and
retrieve the tip after use. It would also be possible to use
something like the "rolling-stent" drive mechanism:
[0255] Disposable tips: Separation of function between tip and
shaft may lead to significant cost reduction for the tip mechanism.
In this case, the tips become a "disposable" element, discarded
after the procedure, and thus eliminating the need for additional
sterilization.
[0256] The modular nature of the tools made possible by this
proposal allows a much greater variety of tool types than are
currently utilized in laparoscopy. It is possible, for example, to
envision tools utilizing integrated diode lasers, for photodynamic
therapy, or optical cauterization; RF cautery; tools incorporating
devices for sensitive electrophysiological measurements including,
for example, mapping of cardiac magnetic fields; devices for
delivery of aerosols, including an ice-mist to cool tissue, or to
deliver drugs.
[0257] We anticipate that the separation of function between shaft
and tool made possible by the present invention will lead to
significant reduction in the complexity and manufacturing cost of
the tools, in many cases reducing tool cost to such an extent that
the tool is disposable after use for a single surgical procedure.
The cost and risks of re-sterilization of tools may thereby be
eliminated.
[0258] In some cases it may be convenient to optically-couple
control signals from shaft to tool, utilizing one or more
selectively-activated photosensitive elements located within the
tool, to switch various electrical functions on and off within the
tip.
[0259] In other cases, it may be possible to use selectively
activate various functions within the tool through use of an RF-ID
tag located within the tool and excited by a transceiver in
proximity to the patient.
[0260] In other cases, it may be possible to selectively-actuate
mechanical elements within the tool comprised of shape-memory or
similar alloys exhibiting a mechanical phase change, via an optical
signal coupled via optical fibers contained in the shaft but
terminating in proximity to the elements to be activated.
[0261] FIGS. 40-60 illustrate specific implementations of
endoscopic instrumentation for both handheld and robotically
assisted tools, where the tool tips 64, such as graspers 30,
scissors 35 and retractors 38, including needle holders and other
actuated as well as not actuated end effectors, are interchangeable
within the surgical cavity and to a common handle 73 that is either
handheld 63 or robotically enabled 21. Furthermore, these tips are
accessed and may be stored while not engaged to the handle, within
the surgical cavity. The action of engaging the end effectors 1, 64
happens within the cavity enabling the handle tube 55 or part of
the handle tube to remain within the surgical space throughout the
duration of the exchange. The tip size and type is expanded because
the tips 64 may be inserted through a different and larger port
than the handle tube 55.
[0262] Securing the Base Tube
[0263] The basic concept has a handle 73 that engages to a tip 64
through a mechanism that secures the actuated and non-actuated
components between the handle 73 and tip 64. The tube 55 aligns a
"T" engagement boss 54 that slides into the tip slot 74 which has a
preferred position slot 75, as shown in FIG. 40. When the "T"
engagement boss 54 meets the preferred position slot 75, as shown
in FIG. 41, the tube rotation handle 28 is rotated such that the
tube 55 and "T" engagement boss 54 rotate into a locked position
within the preferred position slot 75. The handle 73 with the tip
64 attached is shown in FIG. 42. The opposite action is taken to
disengage the tube 55.
[0264] Mechanical Tip
[0265] FIG. 43 shows a mechanical tip 63, and with the tube 55 in a
locked position 69, the handle shaft 47 is extended by opening the
handle lever 66 to a point that the jaws are beyond open 71. This
action causes the handle shaft 47 to engage 70 the shaft latch
mechanism 42, as shown in FIG. 44.
[0266] The shaft latch mechanism has a similar action to the
latching of some common retractable ball point pen where at one end
there is a push button and the other, the writing side of the pen.
By pushing the button, a latching mechanism toggles between a state
were the pen position is set for writing or withdrawn. The action
for engaging the mechanical tips 42 functions similarly where the
handle shaft 47 is disengaged from the tip 63 in the first latch
position; this latch position is similar to when the pen is
extended and set for writing. The handle shaft 47 engages by
extending the shaft 70 into the tip causing the latch 76 state to
toggle; this is similar to the pen being retracted. Using this pen
analogy, the actuation of the handle shaft 47 displacement for
moving the jaws 2 would occur in the travel distance between where
the pen is open and withdrawn. It is important to note that there
are additional states and mechanisms interacting to enable the
functionality of the invention that is beyond the simple analogy of
the retractable ball point pen. This example is only given to bring
the mechanism type into the light of common daily experience.
[0267] The following is a more detailed description of the process
for engaging, operating, and disengaging the mechanical tip 42,
illustrated in FIGS. 45-52. After the tube 55 is in a locked
position 69, the handle shaft 47 is extended by opening the handle
lever 66 beyond open 71. This action causes the handle shaft 47 to
engage the shaft coupling 57 while in its open position 50 and move
towards the shaft coupling 57 distally. The shaft coupling has a
pivot that is connected to the tip shaft 63. The tip shaft 63 is
coupled with the jaws 2 on its most distal end. The engage spring
43 acts over a short distance while the handle shaft 47 is
engaging. The engage spring 43 provides the loading force needed to
actuate the toggle action of the slide ratchet 45. The slide washer
44 holds the engage spring 43 at a specific preload and
displacement so that the tip shaft 53 can freely move axial beyond
the engagement displacement set by the slide washer 44. The slide
ratchet 45 engages with the spin washer 49 and the toggle spring
52. When the shaft coupling 57 in its open state 50 moves distally
by the action of the handle shaft tip 48, it pushes the spin washer
50 to engage with the slide ratchet 45. The spin washer 49, in
contact with the slide ratchet 45, displaces the slide ratchet 45
distally, by pushing on the slide washer 44 and compressing the
engage spring 43. The surface contact between the spin washer 49
and slide ratchet 45 are sloped such that an axial load between
them will cause a rotation torque between the two parts. Both the
spin washer 49 and the slide ratchet 45 are restrained from
rotating by axial grooves and slots along the length of the ratchet
housing 78. While in process of engaging to release 79 the slide
ratchet fingers 87 slides beyond ratchet housing slots 86 allowing
the slide ratchet to rotate to a released 84 position. With the
return of the handle lever to the normal open position 66, the spin
washer 49 moves proximal and the slide ratchet 45 finds the slot 86
and after the tip shaft 53 moves a small distance proximally, the
snap ring 79 captures the slide ratchet 45 such that the slide
ratchet 45 and the spin washer 49 move together as one unit.
[0268] Within the same handle lever to normal open position 66
action, the shaft coupling 57 moves proximally, and opposing teeth
86 on the proximal end of the shaft couplings 57 are forced to
close around the handle shaft tip 48 by a shrinking of the inner
diameter and the tooth obstruction 87 surface. The tip is now fully
engaged with the handle 73. The range of motion is only limited by
the length of the grooves and slots unoccupied and movement occurs
without a spring load because both the engage spring 43 and toggle
spring 52 are internally captured. The action of closing the handle
lever 68 transmits a mechanical linkage to close the jaws, and vice
versa. The tip 64 is secured to the handle and will not release
until an opposite procedure of actions takes place.
[0269] Releasing the tip 64 requires a similar procedure as above.
The tip 64 is placed within its holster not shown. The handle lever
66 is opened 67 so that the jaws go beyond normal open position 71.
This action causes the shaft coupling 57 to slide into a larger
inner diameter section of the housing and for the teeth 86 to
disengage. The handle shaft tip 48 pushes through the shaft
coupling 57 to the spin washer 49, and slides the slide ratchet
fingers 87 beyond ratchet housing slots 86 and causing the slide
ratchet to rotate from the engaged to lock 79 position to the
ratchet to lock 80 position. The release of the handle lever 66
allows the engage spring 43 to move the slide washer proximally
into a locked 81 position. The toggle spring 52 pushes on the
distal ends of the shaft coupling 57 forcing the teeth 86 to expand
allowing the handle shaft tip 48 to be released. The tube 55 is
rotated to release the "T" engagement boss 55 from the proffered
position slot 75. The handle 73 tube 55 and shaft 47 may now be
removed from tip 64.
[0270] Robotic System & Electro-Mechanical Tips &
Handles
[0271] FIGS. 53-55 show a robotic system 100 that includes
electro-mechanical tips 1 and electro mechanical handles 21 where
the handles act as the master over the tips and the tips follow
such that a master-slave relationship exists between the two axes
of the system. The control and actuation are driven with real-time
computation using a computer system with firmware and software to
support the controls of a real-time master-slave system.
[0272] The electro mechanical tip 1 actuates a variety of tips
through the axial displacement and actuation of a tip shaft 48. The
tip shaft 48 is driven by a motor 13 with a lead screw 3 as a shaft
coupled to a lead screw nut 11 connected to tip shaft 48 for
actuating the jaws 2. The lead nut 11 slides on a bearing 12
surface that prevents rotation and allows axial motion. The motor
13 is driven by a printed circuit board 4 that has a controller
chip with computer logic 6 and drivers 5 for controlling the action
of the motor 13 and subsequently the jaws 2. The motor 13 uses
sensors 14 for monitoring the position, velocity and load at the
jaws 2. A battery 15 may be used for powering actuation and/or
control of the motor 13. Radio frequency may be used within the
printed circuit board 4 to communicate state in conjunction with
the battery enabling cordless instrumentation. Sensors 14 may
include but are not limited to: position sensors, POT/encoders,
Ir/image sensors, velocity sensors, tachometers, force sensors,
current sensors, and load cells.
[0273] Alternatively, a cabled power 17, ground 18 and a signal 19
for communication may be implemented through a connector 9 system.
A flat for orientation 20 is included for proper alignment of male
and female sides. The connector system may connect an electro
mechanical handle 21 directly to the electro mechanical tips 1, or
indirectly via a robotic system such as the DA VINCI system by
Intuitive Surgical, Inc. In such a system a robotic slave arm would
connect to the electro mechanical tip and a robotic master arm
would connect to the electro mechanical handles.
[0274] A "T" engagement boss 16 is inserted in a slot 74 until it
reaches a preferred position slot 75. The "T" engagement boss 16 is
rotated until it finds its engaged position 69. The tube 103
rotates independent of the connector 9 system.
[0275] As shown in FIG. 55, the electro mechanical handle 21, has a
handle 101 and a handle lever 102, with a motor 25 and gear
reduction 26 system between them, such that the motor 25 can
actuate the handle lever 102 relative to the handle 101. The motor
25 is driven by a controller printed circuit board/driver/logic 24
and uses feedback from sensors 27 measuring all or a portion of
position, velocity and load, for the control and actuation of the
handle lever 102. The electro mechanical handle 21 may be powered
by a battery 23 and communicate through a wireless radio frequency,
or be powered by a cable 28. Sensors 27 may include but are not
limited to: position sensors, POT/encoders, Ir/image sensors,
velocity sensors, tachometers, force sensors, current sensors, and
load cells.
[0276] For the system where the electro mechanical handle 21
attaches directly to the electro mechanical tips 1, the tube 22 and
the tube 103 are the same tube. The tube rotation handle 28 rotates
the tube for connecting the "T" bar engagement 16 to the tip
housing 104.
[0277] For the robotic system 100, the tube 103 connects to the
robotic slave arm and the Tube 22 connects to the robotic master
arm. For the robotic system 100 the cable 28 can be fed through the
outer tube 22 and into the robotic slave arm.
[0278] End Effectors
[0279] Multiple jaw 2 types can be used in this invention.
Conceivably, all single actuated mechanisms may be utilized.
Fundamentally, the invention enables a coupling between tips that
actuate with a base rod and pushrod. Tips that actuate using a base
rod and a push rod may be controlled under this invention.
Furthermore, end effectors that utilize electricity such as for
cauterizing or where no secondary actuation is needed, may also be
controlled. Several commonly used jaw types are described below as
an example of some of the end effectors enabled by the
invention.
[0280] As shown in FIGS. 56-57, a grasper and/or needle holder 30
end effecter is actuated by the rod moving proximally or rod
tension 33 and holds a needle or tissue with the grasper closed 31
while under tension. When the tip shaft 48 is moved distal or under
compression the grasper is open 32. The pin 60 is connected to the
tip shaft 48 and slides within the leverage slot 61 causing the
grasper blades 110 to pivot around the pivot 62 and open or
close.
[0281] As shown in FIG. 58, a scissor 35 end effecter works
similarly to the grasper except the grasper blades 110 are replaced
by scissor blades 111.
[0282] As shown in FIGS. 59-60, a retractor 38 end effecter works
similarly to the grasper 30 as well, except the leverage slots 61
are angled in the opposite direction so that the movement and
tensioning 41 of the tip shaft 48 causes the blades to open in
tension 40 with a proximal motion and close 39 in compression with
a distal motion.
[0283] FIGS. 61-62 illustrate a modular laparoscopic tool 400 that
is adaptable for use in manual or robotic-controlled hybrid NOTES
procedures according to the present invention. The modular
laparoscopic tool 400 has a proximal assembly 420 and an
attachable/detachable working tip 430. The proximal assembly 420
includes a plurality of small diameter shafts 402, 404 that extend
distally from a common handle 428. There will typically be two,
three or four of the small diameter shafts 402, 404, however more
may be used if necessary for operating the working tip 430 or for
operating more than one working tip 430 by a single proximal
assembly 420. The small diameter shafts 402, 404 will preferably
have a diameter of 1 millimeter or less. The small diameter shafts
402, 404 will preferably be made of a rigid, high-strength
material, for example stainless steel, cobalt-chromium alloy or
titanium alloy or a reinforced composite material, such as a carbon
fiber composite. For laparoscopic use, the length of the small
diameter shafts 402, 404 will typically be from 20 to 40 cm, but
other lengths can be used, particularly for other surgical
approaches. The small diameter shafts 402, 404 may be solid or one
or more of the small diameter shafts 402, 404 may be tubular to
accommodate one or more control members 412, 414 running through
the hollow shafts 402, 404. The control members 412, 414 may be
mechanical (e.g. rods or cables that push, pull and/or rotate),
electrical (to deliver electrical energy and/or control signals),
pneumatic, hydraulic, etc. Alternatively or in addition, the small
diameter shafts 402, 404 themselves may push, pull, rotate and/or
deliver electrical energy and/or control signals. Control signals
may also be transmitted wirelessly or through an umbilical
cable.
[0284] The handle 428 may be adapted for manual control with one or
more control input devices 426 (e.g. buttons, knobs, sliders,
trackballs, joysticks, triggers, etc.) for controlling the
operation of the working tip 430. Alternatively or in addition, the
handle 428 may be adapted for connection to a robotic surgical
system, as described above. As another alternative, the handle 428
may utilize remote control technology to create a
manually-controlled, fly-by-wire laparoscopic tool. Voice controls
may also be combined with the manual or robotic-controlled
embodiments.
[0285] The working tip 430 will typically have an end effector 446,
shown here as a pair of grasper or needle holder jaws 442, 444,
although any of the surgical tools listed above in Table 1 may be
implemented. Optionally, the working tip 430 may have a tip body
432 and a connector body 434 that are connected to one another by a
wrist mechanism 440 that provides rotation and/or angulation of the
end effector 446 with respect to the small diameter shafts 402, 404
of the proximal assembly 420. Alternatively or in addition, the
small diameter shafts 402, 404 may form part of a bar mechanism for
actuation and/or movement and angulation of the working tip 430. As
shown in FIG. 62, the working tip 430 can be connected to the
proximal assembly 420 by inserting the distal ends of the small
diameter shafts 402, 404 into a like number of sockets 436, 438 on
the connector body 434. One or more detents or a locking mechanism,
as described above, may be used to secure the working tip 430 to
the small diameter shafts 402, 404. Optionally, an indicator light
or other indicator means may be used to indicate that a proper
connection has been established.
[0286] The motive power for operating the working tip 430 may
reside in the handle 428 and may be transmitted to the working tip
430 through one or more of the small diameter shafts 402, 404. For
example, the handle 428 may include one or more motors and/or
rotary or linear actuators 422, 424 connected to the working tip
430 by way of the small diameter shafts 402, 404 and/or control
members 412, 414. In this case, the working tip 430 will have one
or more actuator mechanisms 452, 454 (e.g. gears, cams, bar
mechanism, etc.) for translating the linear and/or rotary motion of
the small diameter shafts 402, 404 and/or control members 412, 414
into the desired motion of the end effector 446.
[0287] Alternatively, the motive power for operating the working
tip 430 may reside in the working tip 430 itself. For example, the
actuator mechanisms 452, 454 in the working tip 430 may be one or
more motors and/or rotary or linear actuators that are controlled
by the control input devices 426 on the handle 428 or by a robotic
surgical system. The control signals may be transmitted through the
small diameter shafts 402, 404, wirelessly or through an umbilical
cable. Electrical power may be supplied by a battery on board the
working tip 430 or it may be supplied through the small diameter
shafts 402, 404, wirelessly or through an umbilical cable.
[0288] In use, the small diameter shafts 402, 404 will be inserted
through the skin and the thoracic or abdominal wall 460 through
individual punctures, as shown in FIG. 62. This greatly reduces the
trauma to the patient compared to laparoscopic tools that use a
single larger-diameter shaft. Convalescence time and the risk of
herniation will be minimized. Optionally, the small diameter shafts
402, 404 may have sharpened distal tips 406, 408, as shown in FIG.
61, for piercing the patient's skin and underlying tissues.
Alternative, the punctures through the skin may be formed using a
needle or a small diameter trocar or stylet. A puncture tool may be
provided with the proper number of needles or stylets and the
correct spacing to introduce the small diameter shafts 402, 404
through the tissue. Optionally, the sharpened distal tips 406, 408
may be retractable or removable. In another alternative shown in
FIG. 62, the conical portion of the sharpened distal tips 406, 408
may open up to form engagement members that secure the distal ends
of the small diameter shafts 402, 404 to the working tip 430 and
optionally transmit control actuation to the end effector 446.
[0289] FIG. 63 shows an optional shaft alignment template 470 for
use with the modular laparoscopic tool 400 of FIGS. 61-62. The
alignment template 470 has a preferably flat body 474 with a
plurality of alignment holes 472 equal in number to the number of
small diameter shafts 402, 404. FIG. 63 shows an example of a shaft
alignment template 470 made for a modular laparoscopic tool 400
with three small diameter shafts. The outer shape of the shaft
alignment template 470 can be round, oval, square, triangular or
any practical or esthetically pleasing shape. The alignment holes
472 are sized for a close sliding fit around the small diameter
shafts 402, 404 and are spaced to maintain the alignment of the
small diameter shafts 402, 404 as they enter and pass through the
skin. The alignment template 470 can be made of a metal, polymer or
composite material that can be sterilized for use in a surgical
setting. Optionally, a transparent or translucent polymer may be
used so as not to obscure the surgeon's view of the patient's skin
underneath the alignment template 470.
[0290] In use, the shaft alignment template 470 is placed against
the patient's skin, as shown in FIG. 62, and optionally held in
place with a contact adhesive. The distal ends 406, 408 of the
small diameter shafts 402, 404 are aligned with the holes 472 and
pushed through the skin. The shaft alignment template 470 assures
that the small diameter shafts 402, 404 will be properly aligned
and correctly spaced for attachment to the working tip 430 after
they have passed through the thoracic or abdominal wall 460.
[0291] The working tip 430, or a plurality of working tips 430, are
preferably inserted through a NOTES delivery tool, such as an
endoscope overtube as described above, and advanced to the surgical
site. The working tip 430 is then connected to the proximal
assembly 420 within the body cavity for performing surgery, as
shown in FIG. 62. The working tips 430 may be exchanged as needed
during the surgical procedure. When the surgery is done, the
working tip 430 is disconnected from the proximal assembly 420. The
working tip or tips 430 are withdrawn from the body through the
NOTES delivery tool or directly through the natural orifice that it
was delivered through. The NOTES delivery tool is withdrawn through
the natural orifice where it was inserted. If any internal
incisions were made for surgical access, a suture device may be
used to close the internal incisions, for example using a purse
string suture. A purse string suture can also be placed earlier in
the procedure and used to seal the internal incision around the
NOTES delivery tube during the procedure, then used to close the
incision when the tube is withdrawn. The small diameter shafts 402,
404 are withdrawn from the body, leaving only small puncture wounds
that generally will not require sutures or any other tissue closure
device.
[0292] While the present invention has been described herein with
respect to the exemplary embodiments and the best mode for
practicing the invention, it will be apparent to one of ordinary
skill in the art that many modifications, improvements and
subcombinations of the various features and embodiments,
adaptations and variations can be made to the invention without
departing from the spirit and scope thereof.
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