U.S. patent application number 14/578438 was filed with the patent office on 2015-04-16 for system and method for multi-instrument surgical access.
The applicant listed for this patent is TransEnterix Surgical, Inc.. Invention is credited to Richard A Glenn, Geoffrey A Orth, Aurora Pryor, Jeff Smith, Richard S Stack, Michael S Williams.
Application Number | 20150105629 14/578438 |
Document ID | / |
Family ID | 46327905 |
Filed Date | 2015-04-16 |
United States Patent
Application |
20150105629 |
Kind Code |
A1 |
Williams; Michael S ; et
al. |
April 16, 2015 |
SYSTEM AND METHOD FOR MULTI-INSTRUMENT SURGICAL ACCESS
Abstract
A system for performing multi-tool minimally invasive medical
procedures through a single instrument port in a body cavity
includes a pair of steerable tool cannulas extending from a rigid
tube that is supported by an operating room fixture. The rigid tube
is extendable through an incision to position distal ends of the
rigid tube and tool cannulas within a body cavity. Each tool
cannula has a lumen for receiving a corresponding surgical
instrument so that an end effector of the each instrument may be
used within the body cavity. Control devices are operatively
associated with each tool cannula and include ports for receiving
the surgical instruments. User manipulation of the handles of the
surgical instruments results in steering of the tool cannulas, and
thus the surgical instruments, within the body cavity.
Inventors: |
Williams; Michael S;
(Enterprise, OR) ; Stack; Richard S; (Chapel Hill,
NC) ; Glenn; Richard A; (Santa Rosa, CA) ;
Orth; Geoffrey A; (Sebastopol, CA) ; Smith; Jeff;
(Petaluma, CA) ; Pryor; Aurora; (Stony Brook,
NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TransEnterix Surgical, Inc. |
Morrisville |
NC |
US |
|
|
Family ID: |
46327905 |
Appl. No.: |
14/578438 |
Filed: |
December 21, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13007974 |
Jan 17, 2011 |
8919348 |
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14578438 |
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11804063 |
May 17, 2007 |
8518024 |
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13007974 |
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|
11789381 |
Apr 24, 2007 |
7833156 |
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11804063 |
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60801113 |
May 17, 2006 |
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60801034 |
May 17, 2006 |
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60819235 |
Jul 7, 2006 |
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60794563 |
Apr 24, 2006 |
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Current U.S.
Class: |
600/208 ;
604/95.04 |
Current CPC
Class: |
A61B 1/018 20130101;
A61B 17/3421 20130101; A61B 17/29 20130101; A61B 2017/00278
20130101; A61B 2090/372 20160201; A61M 25/0147 20130101; A61B
1/00128 20130101; A61B 2017/2906 20130101; A61B 2017/3447 20130101;
A61B 2017/3407 20130101; A61B 2017/2905 20130101; A61B 90/50
20160201; A61B 2017/3445 20130101; A61M 2210/101 20130101; A61B
1/00135 20130101; A61B 17/3476 20130101; A61B 1/00052 20130101;
A61B 2017/00225 20130101; A61B 2017/003 20130101; A61B 2017/3486
20130101; A61B 17/0218 20130101; A61B 17/3403 20130101 |
Class at
Publication: |
600/208 ;
604/95.04 |
International
Class: |
A61B 17/34 20060101
A61B017/34; A61B 17/02 20060101 A61B017/02; A61M 25/01 20060101
A61M025/01 |
Claims
1. A surgical system, comprising: an operating room fixture; a
mount attachable to the operating room fixture for support of the
mount in an elevated position relative to a surgical procedure
table; a rigid tube extending distally from the mount, first and
second steerable cannulas extending from a distal end of the rigid
tube, the rigid tube insertable through an incision to position the
distal ends of the rigid tube and the cannulas within a body
cavity; a first control device supportable by the fixture and
including a first instrument port, the first control device
including a first part movably attached to a second part, the first
control device operatively associated with the first cannula such
that movement of the first part relative to the second part results
in steering of the distal end of the first cannula; a first
instrument comprising a first elongate shaft, first end effector,
and first handle, the first end effector removably insertable
through the instrument port of the first control device, and
through the rigid tube and first cannula to position said first
instrument with the first end effector distal to the distal end of
the first cannula and with the first handle positioned such that
manual manipulation of the first handle causes movement of the
first part of the first control device resulting in steering of the
distal end of the first cannula; a second control device
supportable by the fixture and including a second instrument port,
the second control device including a first part movably attached
to a second part, the second control device operatively associated
with the second cannula such that movement of the first part
relative to the second part results in steering of the distal end
of the second cannula; a second instrument comprising a second
elongate shaft, second end effector, and second handle, the second
end effector removably insertable through the rigid tube and second
cannula to position said second instrument with the second end
effector distal to the distal end of the second handle and with the
second handle positioned such that manual manipulation of the
second handle causes movement of the first part of the second
control device resulting in steering of the distal end of the
second cannula.
2. The surgical system of claim 1, further including a scope
removably insertable through the rigid tube.
3. The surgical system of claim 1, wherein the distal portion of
the first cannula further includes a slideable stiffening cannula
advanceable over an exposed portion of the shaft of the first
instrument.
4. The surgical system of claim 1, wherein each control device
includes a third part, wherein the first part is pivotally attached
to the second part and the second part is pivotally attached to the
third part.
5. The surgical system of claim 1, further including an access
cannula positionable in an incision through a body wall, the access
cannula including a lumen proportioned to receive the rigid
tube.
6. The surgical system of claim 1, further including at least one
seal within the rigid tube surrounding the first and second
cannulas.
7. The surgical system of claim 1, wherein the first and second
cannulas include a first, streamlined, position for streamlined
insertion through an incision, and a second spaced-apart position
for triangulation towards a target site within a body cavity.
8. The surgical system of claim 1, wherein each of the first and
second cannulas is retainable in a steered configuration.
9. The surgical system of claim 1, further including a third
instrument exchangeable with the first instrument in the first
cannula.
10. The surgical system of claim 1 wherein the first and second
control devices are first and second control gimbals.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of co-pending U.S.
application Ser. No. 13/007,974, filed Jan. 17, 2011, which is a
continuation of U.S. application Ser. No. 11/804,063, filed May 17,
2007, now U.S. Pat. No. 8,518,024, which claims the benefit of U.S.
Provisional Application Nos. 60/801,113, filed May 17, 2006, and
60/801,034, May 17, 2006, U.S. Provisional Application No.
60/819,235, filed Jul. 7, 2006. U.S. application Ser. No.
11/804,063 is also a Continuation-in-Part of U.S. application Ser.
No. 11/789,381, filed Apr. 24, 2007, now U.S. Pat. No. 7,833,156,
which claims the benefit of U.S. Provisional Application No.
60/794,563, filed Apr. 24, 2006.
FIELD OF THE INVENTION
[0002] The present invention relates to the field of devices and
procedures for use in performing surgery in the peritoneal cavity
using access through a single port in the abdominal wall.
BACKGROUND OF THE INVENTION
[0003] Surgery in the abdominal cavity is typically performed using
open surgical techniques or laparoscopic procedures. Each of these
procedures requires incisions through the skin and underlying
muscle and peritoneal tissue, and thus results in the potential for
post-surgical scarring and/or hernias. Laparoscopic procedures,
while less invasive than open surgical techniques, require multiple
small incisions or ports to gain access to the peritoneal site
using the various instruments and scopes needed to complete the
procedure. The systems disclosed herein allow such procedures to be
performed using only a single port.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] FIG. 1A is a perspective view showing a first embodiment of
a single port surgical system.
[0005] FIG. 1B is cross-section view taken along the plane
designated 1B-1B in FIG. 1A.
[0006] FIG. 2A is a top perspective view showing the distal portion
of the single port surgical system of FIG. 1A.
[0007] FIGS. 2B and 2C are a top plan view and a side elevation
view of the linkage assembly of FIG. 2A. In FIG. 2C, the center
retractor is shown in a downwardly deflected position, and phantom
lines are shown to illustrate the retractor in an upwardly
deflected position.
[0008] FIG. 2D is a top plan view of the linkage assembly of FIG.
2A in the streamlined position.
[0009] FIG. 2E is a perspective view similar to FIG. 2A
illustrating exemplary movement patterns for the tool cannulas and
associated tools.
[0010] FIG. 3A is a perspective view showing the distal end of
slightly modified single port surgical system using an alternative
linkage configuration.
[0011] FIG. 3B is a cross-section view taken along the plane
designated 3B-3B in FIG. 3A.
[0012] FIGS. 4A and 4B are a top perspective view and a bottom
perspective view, respectively, of the distal end of another
embodiment using an additional tool cannula.
[0013] FIGS. 5 and 6 are a perspective view and a cross-sectional
side view of a gimbal assembly.
[0014] FIGS. 7A and 7B are perspective views of the gimbal assembly
of FIG. 5 showing two exemplary locking mechanisms.
[0015] FIGS. 8A and 8B are perspective views of an alternative
gimbal system.
[0016] FIG. 9 is a detailed perspective view of the proximal end of
a procedural cannula and support system using yet another
alternative gimbal system.
[0017] FIG. 10 shows the gimbal system of the FIG. 9
embodiment.
[0018] FIG. 11 is an exploded view of the gimbal system of FIG.
19.
[0019] FIG. 12 is a plan view of the distal surface of the ball of
the gimbal system of FIG. 10.
[0020] FIG. 13 is a plan view of the proximal surface of the ball
of FIG. 12, with the cap removed and shown in perspective view.
[0021] FIG. 14 is a perspective view of an alternative user
interface for the system of FIG. 1A.
[0022] FIG. 15 is a perspective view showing an alternate single
port surgical system having a detachable proximal component. The
proximal and distal components are show separated from one
another.
[0023] FIG. 16 is a detailed view of a portion of the system of
FIG. 15 showing the socket and the hub. The socket is shown
partially cut-away to permit viewing of features located inside
it.
[0024] FIGS. 17A and 17B are perspective views of a pullwire head
and control wire connector illustrating the step of coupling the
two together.
[0025] FIGS. 18A and 18B are perspective views of one embodiment of
an access cannula.
[0026] FIG. 19A is a perspective view of a second embodiment of an
access cannula.
[0027] FIG. 19B is a side elevation view of a modification to the
embodiment of FIG. 19A.
[0028] FIG. 20 schematically illustrates the single port surgical
system of FIG. 1A coupled to a surgical table and having its distal
end extending through an access cannula and into an insufflated
abdominal cavity.
[0029] FIG. 21 schematically illustrates the single port surgical
system of FIG. 1A coupled to a ceiling mount in a surgical theatre
and having its distal end extending through an access cannula and
into an insufflated abdominal cavity.
[0030] FIG. 22 schematically shows a patient lying prone on a
surgical table and illustrates the system of FIG. 1A in use for
surgery on a liver. The patient is shown as partially transparent
to allow the system to be seen.
DETAILED DESCRIPTION OF THE DRAWINGS
[0031] Procedural Cannula and Support System
[0032] The system illustrated in the accompanying drawings allows
surgical procedures to be carried out through a single port formed
in an abdominal wall. The port may be formed using conventional
techniques in a chosen location, or it may be formed through the
umbilicus.
[0033] For certain procedures, it would be advantageous to allow
the surgeon to perform a single port surgical procedure in a manner
that allows him/her to approach the surgical target within the
peritoneal cavity from the same direction from which s/he would
typically approach that same structure using a multi-port
laparoscopic or open surgical procedure. For example, if a
particular procedure utilizes an anterior approach to the treatment
site when carried out using laparoscopic or surgical techniques, it
would also be desirable to allow the surgeon to approach the
treatment site from an anterior perspective even when using a
single port technique. It is also desirable to orient the tools in
a single port system so they will approach the operative tissue
site in the abdominal cavity from the same direction from which
those same tools would have approached the site if introduced
through separate ports using known laparoscopic techniques. The
system illustrated in the attached figures allows familiar
laparoscopic approaches to be used using single port access, thus
allowing a surgeon to easily and intuitively transition between
single port surgical procedures and multi-port laparoscopic
procedures.
[0034] Referring to FIG. 1, one embodiment of a single port
surgical system 100 includes an instrument system 22 and a support
system 24. In use, the support system 24 forms a sort of scaffold
or chandelier within the body to support the instrument system 22
in a location that allows the surgeon to advance the instruments of
the instrument system using a desired approach. Thus, for example,
if performing a procedure that typically uses an anterior approach
when carried out surgically or laparoscopically, the user might
position the support system 24 adjacent the interior of the
abdominal wall.
[0035] Support system 24 includes an elongate overtube 12 that is
extendable through an opening in a body wall, and preferably
through an access cannula 10 positioned in an incision or trocar
puncture in the abdominal wall. The overtube 12 is a rigid or
semi-rigid tubular cannula, although it may be deployable in a more
flexible state and later converted to a self-supporting rigid state
similar to the locking spine described in Applicants' co-pending
U.S. application Ser. No. 11/789,381, Filed Apr. 24, 2007 which is
incorporated by reference.
[0036] Referring again to FIG. 1A, instrument system 22 includes
one or more procedural cannulas or tool cannulas 14 each having a
lumen extending its length. Instruments 16 (e.g., forceps,
endoscopes, suture devices, staplers) are extendable through the
procedural cannulas 14 and into position at the target site in the
peritoneal cavity, with the handles 18 of the instruments remaining
outside the body. Two or three procedural cannulas are useful in
that they allow for the simultaneous use of multiple instruments
16. In the FIG. 1A embodiment, a central retractor 14b is
positioned between the tool cannulas 14. Refractor 14b has a handle
18b that can be manipulated to open/close the retractor jaws.
[0037] The procedural cannulas 14 and central retractor 14b extend
through the overtube 12, allowing for a streamlined system that
occupies a minimal amount of space. An endoscope 20 (FIG. 4B) can
also extend through the overtube 12, allowing the user to observe
the procedure being carried out at the distal end of the system. If
needed, other instruments may extend directly through the overtube
12 towards the operative site and/or they may be supported by
additional procedural cannulas.
[0038] If the system is to be used in procedures requiring
insufflation, all or a portion of the length of the overtube may be
filled with a plug formed of fill material 13 such as silicone or
UV-curable polymer as shown in FIG. 1B. The fill material forms a
seal around the procedural cannulas to prevent leakage of
insufflation gas through the overtube. An additional endoscope
lumen 15 may extend through the fill material for receiving an
endoscope. The inner features of central retractor 14b are not
shown in FIG. 1B.
[0039] Although the overtube 12 is described as formed of tubing,
it can be replaced by any other structure that will bundle the tool
cannulas and associated devices or cannulas (e.g. an endoscope or a
cannula for the endoscope). As one example, instead of extending
the tool cannulas etc. through an overtube, these devices may
instead be bound together using shrink wrap or similar
processes.
[0040] The system 100 includes features that support and orient the
procedural cannulas 14 as appropriate for a given procedure.
Referring to FIG. 1A, the tool cannulas are supported by a linkage
system 26. In this embodiment, the linkage system 26 includes a
pair of members 28. Each member 28 is attached by a corresponding
one of the tool cannulas 14 by a first hinge 30 and to central
retractor 14b (or, alternatively, to a longitudinal tool cannula
like cannula 14a of FIG. 4A) by a second hinge 32. Hinges 30 may be
mounted to corresponding collars 34 on the tool cannulas 14, and
hinge 32 may be on a similar collar 36 (FIG. 2B) on retractor 14b.
When linkage 26 is in the collapsed streamlined position, members
28 extend in a distal direction as shown in FIG. 2D, with the tool
cannulas 14 disposed near the longitudinal axis of the overtube for
passage through the access cannula 10. To deploy the linkage 26,
central retractor 14b is withdrawn proximally, causing the members
28 to pivot at hinges 30, 32.
[0041] Referring to FIG. 2C, central retractor 14b includes a
proximal section 38 and a distal section 40. Proximal section 38 is
formed of a number of segments 42 strung onto one or more cables,
with shorter segments 44 and an instrument tip 46 on the distal
section 40. Cables within the retractor 14b are arranged such that
the retractor becomes rigid when the cables are tensioned, and such
that distal section 40 will deflect when the balance of tension
within the cables is altered using controls (not shown) on the
handle 18b or elsewhere outside the body. For example, retractor
14b may be deflectable towards and away from the body tissue as
shown in FIG. 2C to allow tissue to be lifted by the retractor so
the tissue may be acted upon by an instrument carried by one of the
tool cannulas 14. Additional pull cables (not shown) are operable
to open and close the jaws of the retractor tip 46.
[0042] In the disclosed embodiments, each tool cannula 14
preferably has a pre-shaped curve in its distal region. The curve
orients the cannula 14 such that when the linkage is opened, the
instruments 16 (FIG. 1A) passed through the central lumens of the
cannulas 14 can access a common treatment site. The preformed shape
may be set using any of a number of methods. For example, cannulas
14 can be made of pre-curved tubing having rigidity sufficient to
prevent buckling during use. Reinforcing braid made of stainless
steel or other materials may be formed into the walls of the tubing
in the rigid section of the cannulas 14. In other embodiments, the
shaped region may have a segmented construction as shown in FIG. 2D
(in which the linkage is in the collapsed position) and as similar
to the segmented spine disclosed in co-pending U.S. application
Ser. No. 11/789,381, Filed Apr. 24, 2007. With this design,
individual spine segments are strung over one or more cables. The
segments have individual shapes that collectively will give the
tool cannulas the desired curvature (e.g. one that orients the
cannulas as shown in FIG. 2A) when the cables running through the
segments are tensioned. The entire length of the cannula may be
segmented, or the distal portion may be formed of polymer tubing to
allow flexibility.
[0043] FIG. 3A is a perspective view of modified configuration for
the distal end of the system 100, showing the distal ends of the
tool cannulas 14. In this embodiment, a linkage 26a is pivotally
connected to the cannulas 14 at pivot points 50 and couples the
cannulas 14 to the overtube 12. Linkage 26a also provides
structural support for the distal portions of the tool cannulas 14
and maintains the relative orientation of the cannulas 14. The
linkage 26a is attached to a pivot mount 52 on the distal portion
of the overtube 12. Another of the pivot mounts 54 is coupled to a
pull wire 56 that extends proximally through overtube 12 to a
location outside the body. In an alternative embodiment shown in
FIGS. 4A and 4B, pivot mount 54 may be coupled to the distal
portion of a third longitudinal tool cannula 14a extending
longitudinally from the overtube 12, or to a similarly positioned
tool shaft (e.g. shaft 14b, FIG. 2A). As another alternative,
either or both of the pivot mounts 52, 54 may extend into free
space as shown instead of being attached to the cannula 14a and/or
overtube 12.
[0044] Dashed lines in FIG. 3A show the arrangement of the linkage
26a and pivot mounts 50 when that embodiments in the collapsed
position. When in the streamlined position, the pivot mounts 50 are
positioned side by side, thus orienting the tool cannulas 14
adjacent to one another. When in the deployed position, the pivot
mounts are positioned approximately 3-7 inches apart, and more
preferably approximately 4-6 inches apart. In other words, the
lateral separation between the tool cannulas within the body (i.e.
in a direction perpendicular to the longitudinal axis of the
overtube 12) may be in the range of 3-7 inches.
[0045] The linkage 26a of FIG. 3A may be deployed to the open
position by withdrawing pullwire 56, whereas the FIG. 4A, 4B
embodiment can be deployed by advancing the distal end of the
longitudinal tool cannula 14c in a distal direction to move the
linkage 26a out of the access cannula and/or to deploy the linkage
to the expanded position. In other embodiments, one or more of the
pivot points 50, 52, 54 may be spring loaded to facilitate
expansion of the linkage 26a. Any combination of these deployment
mechanisms, or others not specifically mentioned, may instead be
used to deploy the linkage 26a in the peritoneal cavity.
[0046] Opening the linkage positions the cannulas 14 as shown in
FIGS. 2A, 3A and 4A-4B and thus points the instruments 16
positioned in the cannulas 14 generally towards an operative tissue
site. Once deployed within the body, a preferred system orients the
tool cannulas 14 such that the tools 16 within the cannulas
approach the tissue site from angles mimicking the angles of
approach that those tool would have if introduced using a multiport
laparoscopic procedure. This concept is discussed in greater detail
in connection with FIG. 22.
[0047] The distal end of each tool cannula 14 has a region that is
deflectable in multiple directions to allow positioning and
manipulation of the operative ends of the instruments. This avoids
the need for sophisticated steerable surgical instruments. Instead,
instruments 16 having flexible shafts are positioned in the tool
cannulas 14, and steering of the instruments is achieved by
deflecting the tool cannulas 14. Because the tools 16 are flexible,
it may be necessary to "stiffen" the shaft of the tool 16 to allow
the tool to be successfully used. A slideable stiffening cannula 60
(FIG. 4A) may be advanced from within the tool cannula 14 over a
portion of the shaft of the tool 16 to effectively stiffen the
tool's shaft during the procedure, thus allowing the tool to be
pressed into contact with body tissue without buckling. Other
internal structures such as stiffening mandrels, reinforcing
collars or braids, may instead be used for this purpose. The
segmented or "shape-lock" construction described above in
connection with FIG. 2D may also be used for the tool cannulas to
provide rigidity to the cannulas during tool usage.
[0048] In a preferred embodiment, deflection of the tool cannulas
14 is performed using a pullwire system. Referring to FIG. 3B,
pullwires 128 extend through corresponding pullwire lumens 64,
preferably spaced at intervals of 90.degree.. The distal ends of
the pullwires are anchored in the distal sections of the cannula 14
such that the distal section of the cannula can be made to deflect
in a desired direction by pulling on the desired combination of
pullwires. FIG. 2E illustrates in dashed lines V1 a conical volumes
defined by an exemplary movement pattern for the tool cannula 14,
and the corresponding volume V2 defined by the tool 16 within the
cannula 14.
[0049] Actuation of the pullwires is achieved using features that
during use are positioned outside the body. A deflection system is
provided that allows the user to intuitively actuate the pullwires
for a particular one of the tool cannulas 14 by manipulating the
handle 18 of the instrument 16 that resides within that tool
cannula. For example, if the user wishes to have the distal end of
a tool move in a downward direction, s/he will intuitively raise
the handle 18 of that tool to cause the corresponding tool cannula
to deflect downwardly, thus moving the tool to the desired
position.
[0050] Referring to FIG. 1A, the proximal ends of the pullwires 62
extend from the proximal ends of the cannulas 14 and feed into a
corresponding deflection system, which in the illustrated
embodiments is a control gimbal 66.
[0051] The gimbal 66 may be mounted to a work stand 68 as shown in
FIG. 1A. In use the work stand 68 may be set on top of the
patient's torso, mounted to a fixture within the operating room.
The fixture might be one or both side-rails of the surgical table
(FIG. 20), the ceiling of the surgical theatre (FIG. 21) or a cart
positioned near the surgical table. In any case, the work stand 68
is positioned to give the surgeon convenient and intuitive access
to the handles 18 while s/he observes the procedure on an
endoscopic display (not shown). As shown in FIG. 14, use of the
system may be facilitated by providing a "cockpit" for the user,
coupling an endoscopic display 70 to a work stand 68 that supports
the control gimbals 66, as well as the proximal controls for the
endoscope 20, and optionally other ports for passing instruments
through the access cannula to the peritoneal space.
[0052] The work stand 68 is proportioned to allow the surgeon to
position his or herself in a comfortable position with his/her
hands on the handles 18 of the tools 16. The work stand 68
preferably positions the tool handles 18 approximately 10-15 inches
apart.
[0053] A preferred control gimbal 66 is shown in FIG. 13. It
includes a base 72 mounted to the work stand (not shown in FIG. 5)
and having a tubular end piece having a channel 74. A c-shaped
mount 76 is connected to the base 72 and includes a through hole 78
continuous with the channel of the tubular end piece 74. In a
slight modification, the hole 78 might be accompanied by four
separate through holes 78a-d might be used for receiving pull wires
as in the FIG. 10 embodiment to be discussed below. A ring 80 is
pivotally mounted to the mount 76 at pivot bearings 82. A
semi-spherical ball 84 is pivotally mounted within the ring at
pivots 86. Four pull-wire ports 88 extend from the interior of the
ball 84 to its outer surface.
[0054] Instrument port 90 includes side channels 92 having distal
openings 94 and proximal openings 96. The four pullwires 62 from
the tool cannulas 14 extend through the tubular end piece 74 and
each passes through hole 78, through the hollow interior of the
ball 84, and out corresponding ones of the pull-wire ports 88 in
the ball. The pullwires further extend into the instrument port
side channels 92 and are secured there by anchors 98.
[0055] Instrument port 90 has a lumen 102 extending proximally from
the spherical ball 84. The shaft 18 of an instrument 16 (see FIG.
12A, not shown in FIGS. 13-14) extends through the lumen 102 and
the ball 84, through hole 78 in the c-shaped mount 76, and via tube
74 and the work stand 68 (FIG. 12A), into the corresponding tool
cannula 14. The operative end of the instrument 16 extends from the
distal end of the tool cannula 14.
[0056] When it becomes necessary for the surgeon to change the
orientation of the distal end of an instrument 16, s/he need only
intuitively move the handle 18 of that instrument and the distal
portion of the instrument will deflect accordingly as a result of
the action of the gimbal on the pullwires of the tool cannula.
Vertical movement of the handle 18 will cause the ball 84 to rotate
relative to pivots 86, thus applying tension to the upper or lower
pullwire 62 to cause upward or downward deflection of the tool
cannula 14 (and thus the distal end of the instrument 16). Lateral
movement of the handle 18 will cause the ball 84 and ring 80 to
rotate about pivots 82 and to therefore tension one of the side
pullwires to change the lateral bend of the tool cannula 14. The
control gimbal allows combinations of vertical and lateral
deflection, giving 360.degree. deflection as shown in FIG. 4E. Thus
user may additionally advance/retract the tool 16 longitudinally
within the tool cannula 14, and/or axially rotate the tool 16
relative to the tool cannula when required.
[0057] The control gimbal 66 includes a locking mechanism that
allows an instrument orientation to be temporarily fixed until
further deflection is needed. This feature allows a user to fix a
trajectory for multiple instruments that are to be sequentially
used at a particular location. For example, once the orientation of
a tool cannula 14 is set, a certain step in the procedure may be
performed using a first instrument passed through that cannula.
When a subsequent step requiring a different instrument is to be
performed, the instruments are exchanged without moving the tool
cannula 14. This allows the second instrument to be advanced to the
exact location at which it is needed without additional
steering.
[0058] One exemplary locking mechanism includes a pair of locking
screws 104 that are tightened as shown by arrows in FIG. 7A to lock
the C-mount 76 to the ring 80 and to lock the ring 80 and the ball
84. Alternatively, as shown in FIG. 7B, a simple pneumatic shaft
lock 106 could be employed on each of the gimbals' pivot axes. A
solenoid or similar device might be used in place of the pneumatic
lock 106.
[0059] An alternate gimbal arrangement is shown in FIGS. 8A and 8B.
As shown, a cone shaped instrument port 108 is mounted to the
proximal end of each cannula, and includes a diaphragm seal 110
having a slit 112 sealable around an instrument shaft 114 passed
into the instrument port 108. In FIGS. 16A and 16B only the handle
of instrument shaft 114 is shown to permit easier viewing of the
surrounding features.
[0060] A gimbal 116 includes a collar 118 mounted on the instrument
port 108 and four wings 120 radiating from the collar 118. Each
pullwire 62 is coupled to one of the wings 120. Struts 122 extend
proximally from the wings 120 and are joined to a sleeve 124
through which a portion of the instrument shaft 114 extends. Collar
118 is moveable relative to the instrument port 108, and in
particular collar 118 is rotatable about its central axis, and
pivotable in multiple directions. Movement of the collar 118 places
one or more of the pullwires 62 under tension and results in
deflection of the cannula 14. Since the instrument shaft 114 is
coupled to the collar 118 by struts 122, a user can manipulate the
instrument shaft 114 handle in an intuitive manner similar to a
joystick to allow the user to steer the distal end of the cannula
14 in the desired direction.
[0061] FIGS. 9-10 illustrate a gimbal system similar to that
described in connection with FIG. 5, but that is modified to allow
a user to adjust the sensitivity of the gimbals. In other words,
the gimbal can be fine tuned such that the amount of deflection of
the tool cannulas corresponds directly to the amount by which the
user moves the tool handles 18 within the gimbal system, or the
amount of deflection can be greater than or less than the
corresponding movement of the tool handles.
[0062] Referring to FIG. 10, many of the features of the gimbal 126
are similar to those of gimbal 66 of FIGS. 5 and 6. These similar
features include base 72, which is coupled to work stand or frame
68. Four through-holes 78a-d (three of which are visible in FIG.
10), one for each pull wire, extend from c-shaped mount 76 through
base 72. The pullwires feed into the through-holes 78a-d from cable
housings 128 that pass through the frame 68. The more distal
segments of the pullwires extend from the frame 68 into the tool
cannulas 14 extending distally from the frame 68.
[0063] A ring 80 is pivotally mounted to mount 76 at pivots 82, and
semi-spherical ball 84 is pivotally mounted within the ring 80 at
pivots 86.
[0064] The gimbal 126 of FIG. 10 differs from the gimbal 66 of
FIGS. 5-6 in its use of a microadjustment assembly 130. As with the
prior gimbal arrangements, the four pullwires of one of the tool
cannulas terminate in the gimbal at 90 degree quadrants. Motion of
the instrument shaft 18 (FIG. 1A) alters the tension on the various
pullwires, which causes deflection of the tool cannula tip and
corresponding movement of the tool within the tool cannula. The
effect lever arm of each pull wire is altered in the FIG. 19
embodiment by moving the point of termination of each pull wire
towards or away from the gimbals' center of rotation. Moving the
pullwire terminations away from the center of rotation causes
movement of the tool cannula 14 to be amplified relative to the
movement of the tool handle 18, whereas moving the pullwire
terminations towards the center of rotation decreases the
amplification.
[0065] Ball 84 includes a distal surface 132 as shown in FIG. 12,
and a planar proximal surface 134 as shown in FIG. 11. Four radial
slots 136a-d extend through between the surfaces 132, 134.
Referring to FIG. 11, four sliding terminal plates 138a-d, each
including a pullwire terminal 140a-d and a proximally-extending
follower pin 142a-d, are positioned in contact with the planar
proximal surface 134. A peg 146 on the distal side of each terminal
plate is received in the corresponding one of the slots 136a-d.
[0066] Each pullwire used to deflect the tool cannula extends
through one of the slots 136a-d and is anchored within a terminal
140a-d of one of the four sliding terminals 138a-d. FIG. 12 shows
the distal facing side 132 of the ball 84, with the terminals
140a-d positioned over the slots 136a-d. The pull wires themselves
are not shown.
[0067] A tubular instrument port 148 is centrally positioned on the
proximal surface 134 of the ball 84. A retainer cap 150 covers the
surface 134, such that the instrument port 148 extends through a
central opening 152 in the retainer cap. The sliding terminal
plates 138a-d are sandwiched between the surface 134 and the
retainer cap 150. FIG. 13 shows the cap 150 removed from the ball
84. The inner, distal facing, surface of the cap 150 includes a
spiral rib 154 defining a spiral shaped slot 156. Each of the
follower pins 142a-d of the terminal plates 138a-d is disposed
within the spiral slot 156.
[0068] A retaining ring 158 is engaged with the instrument port 148
and functions to hold the cap 150, terminal plates 138a-d, and ball
84 together such that the follower pins 142a-d remain within the
spiral slot 156. Cap is rotatable in clockwise and counterclockwise
directions relative to the instrument port 148. Rotation of the cap
will increase or decrease the sensitivity of the gimbal system.
More specifically, if the cap is rotated in a first direction, the
spiral rib 154 will cause the pins 142a-d to advance through the
spiral slot towards the outer circumference of the cap, causing the
terminal plates to slide radially outwardly within slots, thereby
increasing the sensitivity of the gimbal system. If the cap is
rotated in a second direction, the pins will advance through the
spiral slot toward the center of the cap, causing the terminal
plates to slide radially inwardly within the slots so as to loosen
the tension on the pullwires and to decrease the sensitivity of the
gimbal system. Markings 160 on the cap 150 and a corresponding
pointer 158 instruct the user as to the level of sensitivity
achieved when the cap is in one of the designated rotational
positions relative to the pointer 158.
[0069] In alternative configurations for adjusting gimbal
sensitivity, the user may have the option to set different
sensitivity levels for different ones of the pull wires.
[0070] The system is preferably packed in a kit containing
instructions for use instructing the user to use the system in the
manner disclosed herein.
[0071] FIG. 15 shows a modified system 100A which differs from the
system of FIG. 1A in that it includes a distal section 170 that is
detachable from the proximal section 172 for disposal or
sterilization. On the distal section 170, tool cannulas 14 extend
from a hub 174, with each of the pullwires 62 from the tool
cannulas 14 extending through the hub and terminating proximally of
the hub as shown. Each pullwire 62 includes a head 176 or crimp on
its proximal end as shown. In the FIG. 15 embodiment, a central
tool cannula 178 also extends through the hub and is coupled to
pivot mount 52 of the linkage 26. An additional cannula 180 (or
alternatively, a tool) is coupled to the pivot mount 54 and is
longitudinally moveable to deploy or collapse the linkage in a
manner similar to that described in connection with FIGS. 4A and
4B.
[0072] The proximal section 172 includes a socket 182 for receiving
the hub 174. A plurality of control wires 184 are positioned with
their distal ends within the socket. Each control wire 184 includes
a connector 186 at its distal end. Each control wire 184 extends
through the frame and through a control wire tube 188. The distal
end of each control wire 184 is coupled to the gimbal 126 in the
same manner in which the pull wires are shown to be connected to
the gimbals of FIGS. 5-8B. A central port 180a (see also FIG. 9)
extends through the mount 68 and allows passage of an endoscope or
other tool into tool cannula 180.
[0073] During assembly of the proximal and distal sections 172,
170, the control wires 184 are coupled to corresponding ones of the
tool cannula pull wires 62, so that manipulation of tool handles 18
(FIG. 1A) within the gimbals 126 will deflect the tool cannulas 14
in the same manner as described above. To connect the control wires
184 and pull wires 62, the head 176 of each pull wire 62 is
inserted into and engaged with the connector 186 of a control wire
184 as illustrated in FIGS. 17A and 17B. The hub 174 is seated
within the socket 182 to securely connect the proximal and distal
sections 172, 170.
[0074] As with the previously described embodiments, the shafts of
instruments extend through instrument ports in the gimbals. See
instrument 148 in the FIG. 10 embodiment. Referring again to FIG.
15, each the tool shaft (not shown but see shaft 17 in FIG. 1A)
extends through an opening 189 in the portion of mount that
supports the gimbal, and extends approximately in parallel to the
control wire tubes 188. The shaft further extends out a port 191
positioned in socket 182 and into a corresponding port 193 in the
hub 174
[0075] FIGS. 18A and 18B give one example of a rigid access cannula
10 which includes a distal end 194 insertable into an incision
formed in a body wall. The incision may be an incision or trocar
puncture formed through the abdominal wall or other body wall, or
through the umbilicus. The access cannula 10 may be unsupported by
additional hardware, or it might include a mount that couples to a
side-rail of the surgical table so as to support and stabilize the
access cannula 10 throughout the procedure.
[0076] A flange 196 surrounds the external surface of the cannula
10 and is positioned to make contact with the skin surrounding the
incision. A side port 198 is positioned to receive insufflation gas
from an appropriate source. Insufflation gas introduced via port
198 will inflate the abdominal cavity to enlarge the working space
available for the procedure. Inflation of the abdominal cavity will
cause a seal to form between the flange 196 and the tissue
surrounding the incision. If necessary, a substance or material
(e.g. silicone, rubber, adhesive, gel, etc.) may be positioned
between the flange and the tissue to facilitate sealing.
[0077] One or more flexible (e.g. rubber) fittings 200a-c extend
from the proximal end of the access cannula 10. Each fitting gives
access to the interior of the access cannula 10. The individual
fittings 200a-c may lead to separate lumens or to a single common
lumen within the access cannula. In a preferred embodiment, a
single lumen having an inner diameter of 15-35 mm is used. During
use of the system, instruments to be passed into the body are
inserted through the fittings into the access cannula. As shown in
FIG. 18B, seals 202 (e.g., silicone, rubber, or other suitable
material) are positioned to seal against the outer surfaces of
instruments such as the overtube 12 and any other instruments
passed through them. Sealing is desirable to prevent loss of
insufflation pressure during the procedure. Each seal has a central
opening 204 that preferably has an inner diameter that is smaller
than the outer diameter of the instrument or collection of
instruments to be passed through it. The access cannula 10
preferably includes an internal seal that prevents loss of
insufflation pressure during times when any or all of the fittings
200a-c is without an instrument. For example, if each fitting is
associated with a separate lumen, duck bill valves may be
positioned within each lumen to form a seal when no instrument is
present in that lumen. If only a single lumen is used, a single
duck bill valve may be used. Stoppers may also be positioned in the
fittings when needed.
[0078] In one embodiment the access cannula 10 is approximately 6
inches in length.
[0079] An alternative access cannula 10a shown in FIG. 19A includes
a single lumen 206 and is provided without the fittings of the FIG.
18A/18B embodiment. In the FIG. 19A embodiment, a pair of proximal,
middle, and distal annular plates 208, 210, 212 are coupled to the
proximal end of the cannula 10a. A proximal seal 214 is anchored
between the proximal plate 208 and the middle plate 210. A distal
seal 216 is anchored between the middle plate 210 and the distal
plate 212 such that the seals are spaced apart from another. The
illustrated seals are annular seals each having an opening having a
smaller diameter than the diameter of the overtube 12. In another
variation shown in FIG. 19B, a portion of the access cannula 10b or
its fittings (including one or all of the fittings of the FIG.
18A/18B embodiment) may include a longitudinally expandable bellows
220 proximal to face plate 209. Bellows 220 expand to accommodate
the linkage prior to its deployment, but that can be compressed
following deployment of the linkage to reduce the overall length of
the access cannula 10.
[0080] The system 100 of FIG. 1A may be used for a variety of
procedures to be carried out within the abdominal cavity, including
resection, bypass, and/or anastomosis of the bowel, appendectomy,
hysterectomy, ovary removal, cholecystectomy, prostatectomy and
other procedures including those currently performed using
laparoscopic or open surgical techniques. Use of the system 100 for
surgery via umbilical access will next be described with reference
to the system 100 of FIG. 1A and the access cannula 10a of FIG.
19A.
[0081] The system 100 is prepared for use by feeding the distal
ends of the instruments 16 into the procedural cannulas 14, with
the distal ends of the instruments preferably remaining within the
lumens of the procedural cannulas 14. If a central tool cannula 14a
is used, the central instrument is similarly fed through that
cannula 14a, and an endoscope is preferably positioned to allow
visualization at the distal end of the tool cannula. The linkage 26
(which has the procedural cannulas 14 coupled to it) is placed in
the collapsed position.
[0082] An incision is formed through a desired location in the
abdominal wall. The umbilicus or navel may be chosen as the
location for the incision since it allows access through an
existing scar and avoids the necessity for additional scars. The
access cannula 10a is inserted into the incision. The collapsed
linkage 26/procedural cannula 14 assembly is inserted into the
access cannula 10a. The proximal and distal seals 214, 216 seal
against the shaft of the overtube 12.
[0083] If the cannula 10 of FIGS. 18A/18B is instead used, the
collapsed linkage 26/procedural cannula 14 assembly may be inserted
into the proximal end fitting 200a of the access cannula 10, an
endoscope is passed into fitting 200b, and any other instrument
needed for the procedure is passed into the fitting 200c. The seals
in the fittings 200a-c seal against the outer surfaces of the
procedural cannulas 14, endoscope, etc.
[0084] Before the linkage 26/procedural cannula 14 assembly is
advanced from the access cannula 10a into the abdominal cavity,
insufflation gas is introduced into the cavity via insufflation
port 198 (FIG. 19A) of the access cannula 19A. Once the cavity has
been inflated, the linkage 26 is moved to the expanded position as
described above (e.g. by advancing central retractor 14b or
procedural cannula 14a (FIG. 4A) in a distal direction using the
handle 18a of central tool/cannula 14a). Expansion of the linkage
26 orients the procedural cannulas 14 as shown in FIG. 2A
[0085] The distal ends of the instruments 16 are advanced from the
procedural cannulas 14, 14a and used to carry out the surgical
procedure. The endoscope 20 may be advanced or oriented into a
convenient position within the cavity. When reorientation of an
instrument 16 is needed, the handle 18 of that instrument is
manipulated, causing the associated control gimbal 126 to engage
the pullwires associated with the procedural cannula 14 carrying
that instrument. Once the procedure is completed, the instruments
are withdrawn into the procedural cannulas 14, the linkage is
collapsed (actively or by withdrawing it into the access cannula
10a). Any other instruments similarly withdrawn from the access
cannula, the access cannula 10 is removed from the body, and the
incision is closed in the usual fashion.
[0086] FIG. 22 schematically illustrates use of the disclosed
system of FIG. 2 as used such as for a cholecystectomy procedure.
According to such a procedure, the overtube 12 (with the procedural
cannulas 14 extending through it) is introduced into the peritoneal
space via a single abdominal port (not shown) and oriented towards
the procedural site as shown. The overtube may be straight, but it
will preferably have a bend tailored towards the quadrant of the
abdominal cavity within which the procedure is to be carried out.
Differently shaped overtubes may be used for different approaches
(e.g. upper right quadrant vs. upper left quadrant approaches). The
liver retractor 16c or retractor 16a (FIG. 2A) is used to lift and
retract the liver superiorly away from the gallbladder and the
operational area of the instruments 16. Instruments 16 are advanced
through the procedural cannulas and used to perform the procedure.
Whereas prior art laparoscopic procedures involve formation of
three surgical ports or incisions labeled W (retractor port), X
(right tool port), Y (scope port), Z (left tool port) in FIG. 22,
use of the disclosed system allows the cholecystectomy procedure to
be performed less invasively while allowing the surgeon to carry
out the procedure from the same familiar perspective from which
s/he would have performed the laparoscopic procedure. Using the
linkage system, tools in the tool cannulas, the central retractor,
and the scope are oriented to approach the operative site from the
approximate directions that they would have taken if they had been
advanced through ports X, Y, W and Z.
[0087] The illustrated embodiments utilize internal scaffold
devices in single port procedures to locate tools at or near the
abdominal walls such that the tools may be manipulated in a way
that is intuitive to the surgeon given his/her experience with
laparoscopic and/or open surgical techniques.
[0088] While certain embodiments have been described above, it
should be understood that these embodiments are presented by way of
example, and not limitation. It will be apparent to persons skilled
in the relevant art that various changes in form and detail may be
made therein without departing from the spirit and scope of the
invention. This is especially true in light of technology and terms
within the relevant art(s) that may be later developed.
[0089] Any and all patents, patent applications and printed
publications referred to above are incorporated by reference.
* * * * *