U.S. patent application number 12/121409 was filed with the patent office on 2009-11-19 for access systems and methods of intra-abdominal surgery.
Invention is credited to J. Landon Gilkey, Donald K. Jones, Dennis L. McWilliams, Vladimir Mitelberg, Brett E. Naglreiter, William Sowers.
Application Number | 20090287045 12/121409 |
Document ID | / |
Family ID | 41316789 |
Filed Date | 2009-11-19 |
United States Patent
Application |
20090287045 |
Kind Code |
A1 |
Mitelberg; Vladimir ; et
al. |
November 19, 2009 |
Access Systems and Methods of Intra-Abdominal Surgery
Abstract
An access system includes a proximal handle, an overtube coupled
to the handle, and an endoscope port extending through handle and
overtube sized for receiving an endoscope therethrough. The
overtube includes anatomic wall securing system that secures a
distal portion of the overtube within a hole in the anatomic wall.
The overtube is provided with a shaped distal portion or a
controllably shapeable distal portion that aids in directing an
endoscope inserted through the port to a particular location within
the peritoneal cavity. The access system includes a system for
insufflating/deflating the peritoneal space separately from the
body cavity accessible via a natural orifice. The access system
includes a closure system to cinch closed the hole made in the
anatomical wall after the access system has been removed from the
hole. Methods are provided for inserting the access system through
the anatomical wall to perform intra-abdominal surgery.
Inventors: |
Mitelberg; Vladimir;
(Austin, TX) ; Sowers; William; (Austin, TX)
; Naglreiter; Brett E.; (Austin, TX) ; Gilkey; J.
Landon; (Austin, TX) ; McWilliams; Dennis L.;
(Austin, TX) ; Jones; Donald K.; (Dripping
Springs, TX) |
Correspondence
Address: |
GORDON & JACOBSON, P.C.
60 LONG RIDGE ROAD, SUITE 407
STAMFORD
CT
06902
US
|
Family ID: |
41316789 |
Appl. No.: |
12/121409 |
Filed: |
May 15, 2008 |
Current U.S.
Class: |
600/104 ;
600/114; 600/115 |
Current CPC
Class: |
A61B 1/00135 20130101;
A61B 2017/00278 20130101; A61B 2017/320056 20130101; A61B
2017/320048 20130101; A61B 1/00082 20130101; A61B 1/00154 20130101;
A61B 1/2736 20130101; A61B 17/32056 20130101; A61B 2017/0472
20130101; A61B 1/3132 20130101; A61B 2017/320044 20130101; A61B
2017/3488 20130101; A61B 17/3478 20130101; A61B 1/01 20130101; A61B
2017/0417 20130101; A61B 2017/3425 20130101 |
Class at
Publication: |
600/104 ;
600/114; 600/115 |
International
Class: |
A61B 1/01 20060101
A61B001/01; A61B 1/018 20060101 A61B001/018 |
Claims
1. An access system for accessing a patient's peritoneal cavity
from a body cavity accessible through a natural orifice, the
peritoneal cavity and body cavity separated by an anatomical wall,
said access system for use with an endoscope, said access system
comprising: a) an overtube having a proximal portion and a distal
portion with a distal end, and a length therebetween sufficient to
extend from a patient's mouth to a patient's stomach, said overtube
defining a lumen for receiving the endoscope therethrough; b) an
anatomical wall securing system at said distal portion of said
overtube that temporarily secures said distal portion of said
overtube within a hole in the anatomical wall; c) a handle at said
proximal portion of said overtube for operating said securing
system; and d) a tubular port extending from said distal end of
said overtube and having a lumen sized to receive an endoscope
therethrough, said tubular port having a shape portion with a
determinable shape, said shape portion adapted to be in a plurality
of shaped configurations including a first shaped configuration
when said shape portion is within the body cavity and a second
shaped configuration when said shape portion is within the
peritoneal cavity.
2. An access system according to claim 1, further comprising: a
system to at least one of insufflate and desufflate the body cavity
and peritoneal cavity separately from the other.
3. An access system according to claim 2, further comprising: a
closure system at said distal end of said overtube for deploying
fasteners into the anatomical wall and to effect closure of the
hole in the anatomical wall by acting on the fasteners.
4. An access system according to claim 1, further comprising: a
closure system at said distal end of said overtube for deploying
fasteners into the anatomical wall and to effect closure of the
hole in the anatomical wall by acting on the fasteners.
5. An access system according to claim 1, wherein: said anatomical
wall securing system includes proximal and distal inflatable cuffs
provided on said overtube.
6. An access system according to claim 5, wherein: said proximal
and distal cuffs are coupled to discrete injection ports extending
from said handle and through said overtube.
7. An access system according to claim 1, wherein: said first
flexible tubular member includes a coil to provide lateral
reinforcement.
8. An access system according to claim 1, wherein: said tubular
port is separable from said overtube and can be withdrawn from and
inserted into said overtube while said anatomical wall securing
system is coupled to the anatomical wall of the patient.
9. An access system according to claim 8, wherein: said tubular
port includes a portion formed with a biased shape to aid in
directing the endoscope.
10. An access system according to claim 9, wherein: said tubular
port is rotatable within the overtube.
11. An access system according to claim 8, wherein: said tubular
port includes a proximal stop larger than said lumen of said
overtube.
12. An access system according to claim 1, wherein: said tubular
port is fixed to said distal end of said overtube.
13. An access system according to claim 12, wherein: said tubular
port includes a portion that defines recesses or cut-outs along its
length.
14. An access system according to 13, further comprising: at least
one control element extending from said handle to said shape
portion, wherein when said control element is tensioned by
actuation from at said handle, said shape portion moves from said
first shape configuration to said second shape configuration.
15. An access system according to claim 14, wherein: said at least
one control element includes a plurality of control elements.
16. An access system according to claim 1, wherein: said tubular
port includes a second shape portion with a determinable shape,
said second shape portion adapted to be in a plurality of shaped
configurations including a first shaped configuration when said
second shape portion is within the body cavity and a second shaped
configuration when said second shape portion is within the
peritoneal cavity.
17. An access system according to claim 8, wherein: said tubular
port includes a second shape portion with a determinable shape,
said second shape portion adapted to be in a plurality of shaped
configurations including a first shaped configuration when said
second shape portion is within the body cavity and a second shaped
configuration when said second shape portion is within the
peritoneal cavity.
18. An access system according to claim 12, wherein: said tubular
port includes a second shape portion with a determinable shape,
said second shape portion adapted to be in a plurality of shaped
configurations including a first shaped configuration when said
second shape portion is within the body cavity and a second shaped
configuration when said second shape portion is within the
peritoneal cavity.
19. An access system according to claim 1, further comprising: a
second tubular port extending from said distal end of said
overtube, said tubular port having a shape portion with a
determinable shape, said shape portion adapted to be in a plurality
of shaped configurations including a first shaped configuration
when said shape portion is within the body cavity and a second
shaped configuration when said shape portion is within the
peritoneal cavity.
20. An access system for accessing a patient's peritoneal cavity
through a from a body cavity through a natural orifice, the
peritoneal cavity and natural orifice separated by an anatomical
wall of the natural orifice, said access system for use with an
endoscope, said access system comprising: a) an overtube including
a first flexible tubular member having a proximal portion and a
distal portion with a distal end, and a length therebetween
sufficient to extend from a patient's mouth to a patient's stomach,
said tubular member defining a lumen for receiving the endoscope
therethrough; b) an anatomic wall securing system at said distal
portion of said overtube that temporarily secures said distal
portion of said overtube within a hole in the anatomic wall; c) a
handle at said proximal portion of said overtube for operating said
securing system; and d) an inflation system integrated into said
handle and overtube, said inflation system to at least one of
insufflate and desufflate the intragastric space and peritoneal
cavity separately from the other, said inflation system including,
a first gas port extending from said handle to a location
intermediate said handle and said anatomic wall securing system, a
second gas port extending from said handle to a location at or
distal said anatomic wall securing system, and a gas control at
said handle to control injection or evacuation of a gas through the
respective first and second gas ports.
21. An access system according to claim 20, further comprising: a
seal for surrounding an endoscope in said lumen of said
overtube.
22. An access system according to claim 20, further comprising: a
self-sealing valve in said lumen of said overtube.
23. An access system according to claim 20, further comprising: a
closure system at said distal end of said overtube for deploying
fasteners into the anatomic wall and to effect closure of the hole
in the anatomic wall by acting on the fasteners, said closure
system actuated at said handle.
24. An access system for accessing a patient's peritoneal cavity
through a natural orifice accessible body cavity, the peritoneal
cavity and body cavity separated by an anatomic wall, said access
system for use with an endoscope, said access system comprising: a)
an overtube including a first flexible tubular member having a
proximal portion and a distal portion with a distal end, and a
length therebetween sufficient to extend from a patient's mouth to
a patient's stomach, said tubular member defining a lumen for
receiving the endoscope therethrough; b) an anatomic wall securing
system at said distal portion of said overtube that temporarily
secures said distal portion of said overtube within a hole in the
anatomic wall; c) a handle at said proximal portion of said
overtube for operating said securing system; and d) a closure
system at said distal end of said overtube for deploying fasteners
into the anatomic wall and to effect closure of the hole in the
anatomic wall by acting on the fasteners.
25. An access system according to claim 24, wherein: said closure
system includes, i) a hollow needle deployment and retraction
system adapted to insert at least one hollow needle into tissue and
thereafter retract said at least one needle from the tissue, ii) a
tissue fastener deployment system able to deploy at least one
tissue fastener through a needle deployed in the tissue, the
fastener having a flexible element attached at a proximal end
thereof, the needle deployment and retraction system operable to
retract a hollow needle from the tissue and over the fastener after
or as the fastener has been deployed into the tissue, and iii) a
cinching mechanism adapted to cinch together the flexible elements
of multiple fasteners deployed through needles into the tissue to
close the hole in the tissue.
26. An access system according to claim 25, wherein: said handle
includes first, second and third actuators, said first actuator to
operate said deployment and retraction system, said second actuator
to operate said fastener deployment system, and said third actuator
to operate said cinching mechanism.
27. An access system according to claim 25, wherein: said access
system is pre-loaded with a plurality of fasteners.
28. An access system according to claim 27, wherein: said fasteners
each have a shaft with a head at a one end and said flexible
element at an opposite end, said fastener assuming a loaded first
configuration and a deployed second configuration, wherein in said
loaded first configuration, said head is substantially parallel to
said shaft such that said fastener can be loaded into and pushed
through said needle, and in said deployed second configuration,
said head is transverse to said shaft.
29. A method of intra-abdominal surgery, comprising: a) inserting a
distal end of a natural orifice translucent endoscopic surgery
(NOTES) access system into a hole in an anatomic wall, the access
system having an overtube with a distal end; b) securing the access
system to the anatomic wall at the hole; c) inserting an endoscope
through the overtube of the access system; and d) using a port
having a shaped portion at the distal end of the overtube to direct
the endoscope along a determined trajectory, the endoscope
extending through the port.
30. A method according to claim 29, further comprising: before
inserting the access system into the hole in the anatomic wall, i)
making a piercing through the anatomic wall, ii) inserting a
balloon into the piercing; and iii) expanding the balloon to dilate
the piercing and define the hole in the anatomic wall.
31. A method according to claim 30, wherein: the anatomic wall is
the vaginal wall.
32. A method according to claim 30, wherein: the anatomic wall is a
wall of intragastric system.
33. A method according to claim 32, wherein: the anatomic wall is
the stomach wall.
34. A method according to claim 33, wherein: said making a piercing
includes piercing the stomach wall from an exterior of the
intragastric space to the interior of the intragastric space.
35. A method according to claim 33, wherein: said making a piercing
includes piercing the gastric wall from an interior of the
intragastric space to the exterior of the intragastric space.
36. A method according to claim 29, further comprising: inserting a
tunneling instrument through the port to form a tunnel between
first and second tissues.
37. A method according to claim 36, further comprising: inserting a
dissecting instrument into tunnel and expanding the dissecting
instrument to dissect the first and second tissues from each
other.
38. A method according to claim 37, wherein: at least one of the
tunneling instrument and the dissecting instrument includes a
balloon which upon expansion tunnels and/or dissects.
39. A method according to claim 37, wherein: the dissecting
instrument and tunneling instrument are integrated into a single
instrument.
40. A method according to claim 37, wherein: the first tissue is
the gallbladder and the second tissue is the liver.
41. A method according to claim 29, further comprising: inserting a
multilumen device through said port; and inserting instruments
through a plurality of lumen of said multilumen device.
42. A method according to claim 29, wherein: the access system has
a proximal handle, and the port is removable from said overtube at
the handle.
43. A method according to claim 29, wherein: changing the shape of
the shape portion of the port before the endoscope is within the
port but while the port is within the patient.
44. A method according to claim 29, further comprising: changing
the shape of the shape portion of the port while the endoscope is
within the port.
45. A method of intra-abdominal surgery, comprising: a) inserting a
distal end of a natural orifice translucent endoscopic surgery
(NOTES) access system into a hole in wall of a body cavity
accessible through a natural orifice, the access system having an
overtube with a distal end; b) securing the access system to the
wall at the hole; c) inserting a tunneling instrument through the
overtube to form a tunnel between first and second tissues within
the peritoneal space; and d) inserting a dissecting instrument
through the overtube and into the tunnel and expanding the
dissecting instrument to dissect the first and second tissues from
each other, wherein at least one of the tunneling instrument and
the dissecting instrument includes a balloon which upon expansion
tunnels and/or dissects.
46. A method according to claim 45, further comprising: before
inserting the access system into the hole, i) making a piercing
through the wall, ii) inserting a balloon into the piercing, and
iii) expanding the balloon to dilate the piercing and define the
hole in the wall.
47. A method according to claim 45, wherein: the anatomic wall is
the vaginal wall.
48. A method according to claim 45, wherein: the anatomic wall is a
wall of intragastric system.
49. A method according to claim 48, wherein: the anatomic wall is
the stomach wall.
50. A method according to claim 45, wherein: both of said tunneling
and dissecting instruments include expandable balloons.
51. A method according to claim 45, wherein: said first tissue is
the gallbladder and the second tissue is the liver.
52. A method according to claim 45, wherein: the dissecting
instrument and tunneling instrument are integrated into a single
instrument.
53. A method according to claim 46, wherein: said making a piercing
includes piercing the wall from an exterior of the body cavity to
the interior of the body cavity.
54. A method according to claim 46, wherein: said making a piercing
includes piercing the wall from an interior of the body cavity to
the exterior of the body cavity.
55. A method according to claim 45, further comprising: using a
port at the distal end of the overtube to direct the endoscope
along a predetermined trajectory, the endoscope extending through
the port.
56. A method of modifying the gas pressure between a body cavity
accessible through a natural orifice and the peritoneal cavity of
the human body, comprising: a) securing a natural orifice
translucent endoscopic surgery (NOTES) access system within a hole
in the wall between the body cavity and the peritoneal cavity, the
access system having i) an overtube including a flexible tubular
member having a proximal portion and a distal portion with a distal
end, said tubular member defining a lumen for receiving the
endoscope therethrough, ii) an anatomic wall securing system at
said distal portion of said overtube that temporarily secures said
distal portion of said overtube within a hole in the wall, iii) a
handle at said proximal portion of said overtube for actuating said
securing system; and iv) an inflation system integrated into said
handle and overtube to insufflate and deflate the body cavity
separately from the peritoneal cavity, said inflation system
including, a first gas port extending from said handle to a
location intermediate said handle and the wall securing system, a
second gas port extending from said handle to a location at or
distal said anatomic wall securing system, and a gas control at
said handle to control injection or evacuation of a gas through the
respective first and second gas ports; and b) injecting or
evacuating gas through said overtube to modify the gas pressure
within the one of the body cavity and the peritoneal cavity.
57. A method of intra-abdominal surgery within the peritoneal
cavity, comprising: a) introducing a natural orifice translucent
endoscopic surgery (NOTES) access system into a body cavity
accessible through a natural orifice, the access system having a
proximal end including a handle, and a distal end with a closure
system; b) deploying a plurality of hollow needles from the closure
system into an anatomic wall separating the body cavity and the
peritoneal cavity; c) inserting a plurality of tissue fasteners
through the needles, the fasteners each having a flexible element
attached at a proximal end thereof; d) retracting the needles from
the anatomic wall after each fastener is inserted therethrough; e)
defining a hole in the anatomic wall between the inserted
fasteners; f) securing the access system within the hole in the
anatomic wall; g) performing a surgical procedure within the
peritoneal cavity; h) removing the access system from the hole in
the anatomic wall; and i) closing the hole in the anatomic wall by
cinching together the flexible elements at the proximal ends of the
fasteners.
58. A method according to claim 57, wherein: said surgical
procedure includes separating the gallbladder from the liver.
Description
RELATED APPLICATIONS
[0001] This application is related to U.S. Ser. No. 11/775,996,
filed Jul. 11, 2007, and U.S. Ser. No. 12/030,244, filed Feb. 13,
2008, which are hereby incorporated by reference herein in their
entireties.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to access systems for
accessing and providing access to the peritoneal cavity via a body
cavity accessible through a natural orifice, and methods of
performing intra-abdominal surgical procedures through such an
access system using an endoscope.
[0004] 2. State of the Art
[0005] Traditional gallbladder removals are either performed via
laparoscopic or open surgery techniques Laparoscopic procedures
utilize electrocautery electrodes to dissect the gallbladder. These
electrodes remain dangerously hot and may cause damage to adjacent
viscera. Moreover, the surgical approach requires a large wound or
several holes through the abdominal wall.
[0006] The field of gastrointestinal endoscopy has for many years
been limited to diagnostic and therapeutic techniques to observe,
modify and remove tissues located in the digestive tract. Only
recently have there been efforts to expand gastrointestinal
endoscopic surgery to within the peritoneal cavity to remove large
tissue masses such as the appendix and gallbladder. Generally, in
these newer procedures, a natural orifice translucent endoscopic
surgery (NOTES) access system is used to gain access to the
peritoneal cavity through the stomach or another natural orifice.
However, there are still significant limitations to the techniques
for visualizing, manipulating and removing masses of tissue on
current NOTES systems. In particular, once the NOTES system is in
place, an endoscope is used to navigate instrumentation to the
subject tissue for removal. Endoscopes are limited in their
maneuverability, generally having only a single axis along which
they can be bent to direct instrumentation.
[0007] Further, the en bloc removal of large tissue masses, such as
the gallbladder, presents numerous problems for current endoscopic
tools and techniques. Currently, access to and removal of these
types of tissue masses requires tissue separation and dissection
that can be particularly difficult from an endoscopic approach.
Also, after removal of tissues from the surgical site, current
system require extremely skilled closure techniques. These closure
techniques can prevent acceptance of such procedures from a large
number of even skilled surgeons and also greatly increase the time
for completing a procedure and the safety of the patient.
SUMMARY OF THE INVENTION
[0008] According to embodiments of the invention, an access system
is provided for enabling and facilitating access to the peritoneal
cavity from a body cavity accessible through a natural orifice,
such as an intragastric approach or a transvaginal approach. The
access system includes a proximal handle, an overtube coupled to
the handle, and an endoscope port extending through handle and
overtube sized for receiving an endoscope therethrough. The
overtube includes a securing system that secures a distal portion
of the overtube within a hole in an anatomical wall of a body
cavity accessible through a natural orifice. In a preferred
embodiment, the securing system includes proximal and distal
inflatable cuffs provided on an external portion of the overtube.
The cuffs are coupled to discrete injection ports extending from
the handle through the overtube that permit individual
pressurization to fixate the cuffs on opposite sides of the
anatomical wall. The anatomical wall can be captured between the
two cuffs to secure the access system to the anatomical wall and
provide a seal between the space of the natural orifice accessible
body cavity (e.g., intragastric space) and the peritoneal cavity.
The overtube is also provided with a shaped distal portion or a
controllably shapeable distal portion that aids in directing an
endoscope inserted through the port to a particular location within
the peritoneal cavity. The access system is optionally provided
with means for insufflating/deflating the peritoneal space
separately from the body cavity (e.g. intragastric space). In
addition, the access system optionally includes a closure means for
deploying and acting on fastening to effect closure of the hole
made in the anatomical wall in which the access system is secured
to seal the hole after the access system has been removed from the
hole.
[0009] In one embodiment, the preshaped distal portion of the
access system is a preshaped portion of a port separate from the
overtube and extendable therethrough. The preshaped port is molded
or otherwise formed with a biased shape to aid in directing an
endoscope to a particular location within the peritoneal cavity.
After the overtube is inserted into the patient, the preshaped port
is inserted through the overtube, which initially counters the bias
so that the biased distal portion of the port straightens as its
passes through the overtube. Once the distal portion of the port
exits the distal end of the overtube, the port assumes the shape of
its preshape, thereby able to direct an endoscope or other
instruments to a designated structure. The port can be rotated
within the overtube to redirect the instruments. At the conclusion
of the procedure, the port is withdrawn from the overtube and then
the overtube is removed from the patient.
[0010] In another embodiment, the preshaped distal portion is
configured from an integral tubular element that is cut to define
segmental recesses or cut-outs along its length. One or more pull
wires extend from the handle of the access system to the distal
end. When the appropriate pull wire(s) is/are activated at the
handle, the tubular element bends along the cutouts and can be
maintained in such configuration to orient the endoscopic port
toward the target tissue. If necessary to reconfigure the access
port or at the conclusion of the procedure, the handle can be
operated to release the tension on the wire(s) and straighten the
distal portion to aid in withdrawing the access port from the
patient.
[0011] The means to control insufflation/deflation includes a first
port extending from the handle to a location intermediate the
handle and the proximal cuff, and a second port extending from the
handle to a location at or distal the distal cuff. The handle is
also provided with a gas control system to inject or evacuate air
through the respective first and second ports. In embodiments
including means to control insufflation/deflation, the endoscopic
port includes a seal sealing valve, preferably located within the
handle. In this manner, once the cuffs have separated the natural
orifice from the peritoneal space, the pressures in the peritoneal
space and natural orifice accessible body cavity can be separately
controlled, e.g., to reduce stomach pressure while maintaining
peritoneal pressure to provide increase visibility at the surgical
site.
[0012] The closure means facilitates rapidly closure of the hole in
the anatomical wall. In one embodiment, the closure means includes
a cinching system preferably incorporating T-tags. In such
embodiment, the access port is operable to implant hollow needles
in a spaced apart manner about the hole. The access port is then
operable to insert T-tags having a trailing suture through the
hollow needles. Then, means are integrated with the access port or
an independent tool is operable therewith that cinches the suture
of the T-tags together about the hole to effect closure at the
appropriate point in the procedure.
[0013] The access system facilitates methods of getting through the
anatomical wall. According to a first method, described with
respect to an intragastric approach, an initial piercing is made
from the exterior of the stomach to the interior of the stomach.
According to a second method, also described with respect to an
intragastric approach, an initial piercing is made from the
interior of the stomach to the exterior of the stomach. Both
methods include the dilatation of the stomach piercing using a
balloon catheter. Once inside the peritoneal cavity and
sufficiently oriented towards a surgical site a medical procedure
can be conducted. By way of example, the gallbladder can be
separated from the liver using tunneling and dissection balloons.
Such methods are also useable in a transvaginal approach to a
medical procedure.
[0014] Additional objects and advantages of the invention will
become apparent to those skilled in the art upon reference to the
detailed description taken in conjunction with the provided
figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is a broken side elevation of a first embodiment of
an access system according to the invention.
[0016] FIG. 2 is a broken section view of an overtube of the access
system of FIG. 1.
[0017] FIG. 3 is a cross sectional view across line 3-3 in FIG.
2.
[0018] FIG. 4 is a broken side elevation view of a shaped port
device of the access system of FIG. 1, shown in two different
configurations.
[0019] FIGS. 5 through 21 illustrate methods of securing the access
system of FIG. 1 within the stomach wall to access the peritoneal
cavity.
[0020] FIG. 22 is broken side elevation view of a balloon tunneling
device for use with methods of the invention.
[0021] FIG. 23 is an enlarged broken longitudinal section view of
the distal end of the balloon tunneling device of FIG. 22.
[0022] FIG. 24 is broken side elevation view of a balloon
dissection device for use with methods of the invention, with the
balloon shown in collapsed and expanded states.
[0023] FIG. 25 is an enlarged broken longitudinal section view of
the distal end of the balloon dissection device of FIG. 24.
[0024] FIGS. 26 through 35 illustrate a method of performing an
intra-abdominal surgery through the access system secured within
the stomach wall.
[0025] FIG. 36 is a broken side elevation of a second embodiment of
an access system according to the invention.
[0026] FIG. 36A is a broken side elevation of the access system of
FIG. 36, showing bending of the port into a pre-shape.
[0027] FIG. 37 is an enlarged schematic view of the preshaped port
shown in non-actuated and actuated (broken line)
configurations.
[0028] FIGS. 38 through 47 illustrate a method of securing the
access system of FIG. 36 within the stomach wall to access the
peritoneal cavity.
[0029] FIG. 48 is broken side elevation view of a third embodiment
of an access system according to the invention.
[0030] FIG. 48A is a cross-section across line 48A-48A in FIG.
48.
[0031] FIG. 49 is broken side elevation view of a fourth embodiment
of an access system according to the invention.
[0032] FIG. 50 is broken side elevation view of a fifth embodiment
of an access system according to the invention.
[0033] FIG. 51 is a broken perspective view of a sixth embodiment
of an access system according to the invention.
[0034] FIG. 52 is a enlarged broken perspective view of sixth
embodiment of the access system coupled to the stomach wall to
access the peritoneal cavity.
[0035] FIG. 53 illustrates the access system being used to deploy
hollow needles into the stomach wall.
[0036] FIG. 54 illustrates a T-shaped fasteners in a collapsed
configuration being forced through a needle into the opposite side
of the stomach wall.
[0037] FIG. 55 illustrates the access system being used to deploy
fasteners through the hollow needle and the stomach wall.
[0038] FIG. 56 illustrates the T-shaped fasteners deployed within
the stomach wall and the hollow needles retracted within the access
system.
[0039] FIG. 57 illustrates the access system being used to cinch
the fasteners together about a hole in the stomach wall to provide
closure of the hole.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0040] Turning now to FIGS. 1 through 3, a natural orifice
translucent endoscopic surgery (NOTES) access system 10 is provided
for enabling and facilitating access to the peritoneal cavity
through an anatomical wall, the anatomical wall separating the
peritoneal cavity and a natural orifice accessible body cavity.
While the invention is primarily described with respect to a
through-the-esophagus transgastric approach for such surgery, where
the body cavity is the stomach and the anatomical wall is the
stomach wall, the systems and methods described herein are equally
applicable to procedures performed transanally, wherein the body
cavity is the colon and the anatomic wall is the colon wall, and
transvaginally wherein the body cavity is the vagina and the
anatomic wall is the vaginal wall.
[0041] The access system 10 includes an overtube 12 and a discrete
preshaped port 14 insertable therethrough. The overtube 12 includes
a first tubular member 16, a circular lumen 18 defined through the
center of the first tubular member, and a handle 20 provided at the
proximal end of the first tubular member 16. The overtube 12 has
length in the range of 10 to 50 inches with a preferred range of 25
to 35 inches; a lumen diameter in the range of about 8 to 18 mm;
and an outer diameter in the range of about 10 to 25 mm. The
overtube 12 includes a gastric wall securing system that secures a
distal portion of the overtube within a hole in the gastric wall.
In a preferred embodiment, the gastric wall securing system
includes proximal and distal inflatable cuffs 22, 24 provided on an
external portion of the distal end 25 of the first tubular member
16. The cuffs 22, 24 are in communication with respective injection
ports 26, 28 at the handle 20 through air channels 30, 32 to permit
individual pressurization with a fluid, e.g., air, to fixate the
cuffs on opposite sides of the gastric wall. This secures the
overtube 12 to the gastric wall and provides a seal between the
intragastric space and the peritoneal cavity, as described in more
detail below.
[0042] The first tubular member 16 is sufficiently longitudinally
flexible to assume the contour required for insertion through a
patient's esophagus and into the stomach. Notwithstanding the
longitudinally flexibility, the first tubular member preferably has
sufficient lateral strength and stability to maintain the
cross-sectional shape of the lumen along its length. Such strength
may be provided by a metal or a polymeric coil or braid
reinforcement along its length.
[0043] Referring to FIGS. 1, 2 and 4, the preshaped port 14 has a
proximal instrument receiving end 40 and a second tubular member
42. The port 14 has length in the range of 20 to 60 inches, with a
preferred range of 30 to 45 inches; a lumen diameter in the range
of about 5 to 16 mm; and an outer diameter in the range of about 8
to 18 mm. The port body length is sufficient to extend from a
patient's mouth to a patient's stomach or from any other natural
orifice to a body cavity accessible therefrom. The receiving end 40
is sized to prevent passage through the lumen 18 of the overtube 12
and functions as a stop against the handle 20 of the overtube 12.
The second tubular member 42 has a distal portion 44 preshaped so
that it is biased to bend in a predetermined direction and
preferably by a predetermined amount; i.e., the preshape is a
portion biased to curve at a distal portion of the second tubular
member 42 (as shown in broken lines in FIG. 4). The second tubular
member 42 can be molded or extruded, and heat treated, provided
with a metal or polymeric shape providing/effecting element, or
otherwise formed with such biased shape. The preshape bias is
readily overcome such that when the distal portion 44 is inserted
through the lumen 18 of the first tubular member 16 of the overtube
12, the preshaped distal portion 44 straightens or otherwise
conforms to the longitudinal shape of the first tubular member 16
of the overtube. However, once the preshaped distal portion 44
extends from the distal end of the overtube 16, the preshaped
distal portion 44 of the port 14 conforms to its bias, thereby able
to direct an endoscope or other instrument(s) extending within and
through its lumen 46 toward a designated anatomical structure. The
port 14 can be also rotated within the overtube 12 to further
direct or redirect the endoscope and/or instrument(s) toward
anatomical structures. The port 14 can be withdrawn together with
or separately from the overtube 12 as the access system is removed
from the patient.
[0044] Turning now to FIG. 5, a method of intra-abdominal surgery
on a patient 50 using the access system 10 is now described. The
access system 10 facilitates methods of accessing tissue 54 in the
peritoneal cavity 56 through the stomach wall 52. According to a
first method, described below, an initial piercing is made from the
exterior of the stomach 58 to the interior of the stomach.
According to a second method, also described below, an initial
piercing is made from the interior of the stomach to the exterior
of the stomach. Both methods include the dilatation of the stomach
piercing using a balloon catheter to create a hole in stomach wall
52 of sufficient dimension to receive the distal end of the access
system. The distal end of the access system is then anchored within
the hole with cuffs 22, 24 (FIG. 1) at the distal end 25 of the
access system. Once a passageway is provided through the access
system 10 to the peritoneal cavity 56, the access system can be
used to orient an endoscope 60 toward a tissue 54 in the peritoneal
cavity 56, e.g., using the preshaped port, as described in more
detail below. Then, by way of example, the tissue, such as the
gallbladder, can be separated from other tissue, such as the liver,
using tunneling and dissection balloons or other techniques.
[0045] More particularly, turning now to FIGS. 5 and 6, with the
port 14 (FIGS. 1 and 4) removed from the access system 10, a
steerable endoscope 60 is inserted through the lumen of the
overtube 12. The overtube 12 and endoscope 60 are inserted together
into the stomach 58 of the patient 50, with the endoscope 60
steering the assembly through the natural orifices, esophageal
sphincter, and into the stomach. The distal end 25 of the overtube
12 with the endoscope is maneuvered adjacent the stomach wall
52.
[0046] Referring to FIGS. 7 and 8, in accord with one embodiment of
the method, a piercing catheter (or other preferably tubular
piercing/cutting instrument) 70 is inserted into the patient's
peritoneal cavity 56 from outside the stomach wall 52. The piercing
catheter 70 can be provided into the peritoneal cavity 56 by
insertion through the abdominal wall, by introduction up the colon
via an endoscope and then piercing through the colon into the
peritoneal cavity 56, or by introduction through the vagina. The
piercing catheter 70 is pierced through the stomach wall 52 and
introduced into the stomach 58.
[0047] Referring to FIG. 8, a snare device 72 is introduced through
the piercing catheter 70 and into the stomach 58. A balloon
catheter 74 fixed along a guidewire 76 is introduced into the
stomach 58 through the endoscope 60. The guidewire 76 is preferably
integrated with the balloon catheter 74.
[0048] Referring to FIGS. 9 and 10, the snare device 72 and cutting
instrument 70 are operated to grasp the guidewire 76 and/or balloon
catheter 74, and pull the balloon catheter 74 through the piercing
78 in the stomach wall 52. Once the balloon 80 on the balloon
catheter 74 is positioned within the piercing 78, the snare device
72 releases the guidewire 76 and/or balloon catheter 74 so as to
decouple the snare device 72 from the balloon catheter 74, as shown
in FIG. 11.
[0049] Referring to FIGS. 12 through 14, in accord with an
alternate embodiment of positioning a balloon catheter within a
piercing in the stomach wall, once the distal end 25 of the
overtube and endoscope 60 are positioned within the stomach 58
adjacent the stomach wall 52, a cutting instrument (not shown) is
advanced through the endoscope (or a port provided within the
overtube) to define a piercing 78 in the stomach wall 52 from the
interior of the stomach. The guidewire 76 and balloon catheter 74
are then advanced through the piercing to position the balloon 80
within the piercing 78.
[0050] Then, referring to FIGS. 15 through 17, regardless of the
method used to position the balloon 80 within the piercing 78, the
balloon 80 is expanded upon activation from outside the patient by
pressurizing a fluid through the balloon catheter 74. The balloon
80 can be located partially inside the distal end 25 of the
overtube (as shown) or completely external the distal end of the
overtube. As the balloon 80 is expanded, the piercing 78 (FIG. 14)
is dilated to create a hole 82 of sufficient size to receive the
distal end 25 of the overtube. The proximal cuff 22 is expanded,
and the distal end 25 of the overtube is inserted through the hole
82 up to cuff 22. Then the distal cuff 24 is expanded to secure the
distal end 25 of the overtube to the stomach wall 52 between the
proximal and distal cuffs 22, 24 and to thereby provide a seal
between the intragastric space (at the stomach 58) and the
peritoneal cavity 56.
[0051] Referring to FIG. 18, the balloon 80 is deflated, and the
balloon catheter 74 and guide 76 are withdrawn from the overtube
12. The endoscope 60 (FIG. 12) can then be used within the
peritoneal cavity 56 along with other instruments advanced within
the overtube.
[0052] However, referring to FIGS. 19 through 21, in accord with a
preferred aspect of the method, the endoscope is also withdrawn
from the overtube 12 and the preshaped port 14 is advanced through
the overtube 12 into the peritoneal cavity 56. As the preshaped
port 14 is advanced to an extent allowing the preshaped distal
portion 44 to bend in accord with it preshaped bias, the port 14
will provide a predefined (although rotationally orientable)
pathway for re-introduction of the endoscope 60 into the peritoneal
cavity 56. The endoscope 60 is then reintroduced through the port
14.
[0053] It is appreciated that various surgical procedures can be
performed once the endoscope and other instruments are located in
the peritoneal cavity. For example, the access system 10 can be
used to perform a cholecystectomy, or dissection of the gallbladder
from the liver. In accord with a preferred method of performing a
cholecystectomy, tunneling and dissecting instruments, as disclosed
in previously incorporated U.S. Ser. No. 11/,775,996, are
preferably used in conjunction with the access system 10. While
detailed descriptions of suitable instruments are described in the
aforementioned application, it is helpful to generally describe the
tunneling and dissection instruments here for a point of
reference.
[0054] Referring to FIG. 22, a tunneling instrument 150 includes a
catheter 152 having proximal and distal ends and a balloon member
154 located adjacent the distal end. Positioned on the exterior of
catheter 152 adjacent the distal end is a series of markers 156.
These markers may be visible under direct visualization of the
endoscope and may be additionally visible under fluoroscopy.
Adjacent the proximal end of catheter 152 is an auxiliary device
port 158. The proximal end of catheter 152 is attached to connector
tubing 160 to access inflation port 162. Valve assembly 164
provides a seal for fluid introduced into inflation port 162.
Tether slide 166 is slidably positioned on handle body 168. Handle
body 168 includes distance markers 170 to gauge the movement of
tether slide 166. A cross sectioned view of the distal end of
tunneling instrument 150 is shown in more detail in FIG. 23.
Catheter 152 has a distal end 172 and a first lumen 174. Located
within first lumen 174 is balloon member 154. The balloon member
154 is preferably non-compliant of the type generally known in the
art, however, balloon member 154 may be of the compliant or
semi-compliant type. The balloon member 154 may be formed from
biocompatible polymer types such as olefins, elastomers,
thermoplastic elastomers, vinyls, polyamides, polyimides,
polyesters, fluropolymers, copolymers and blends of any of the
aforementioned. The proximal end 176 of balloon member 154 is
attached to the distal end 172 of catheter 152. The distal end 178
of balloon member 154 is positioned within the first lumen 174 in
an everted configuration. A tether member 180 is connected to the
distal end 178 of balloon member 154. Tether member 180 is flexible
and preferably takes the form of a filament, as shown, however
tether member 180 may take the form of a tube. The proximal end of
tether member 180 is connected to tether slide 166 through valve
assembly164. Tether member 180 aids in initially positioning
balloon member 154 within the first lumen 174 of catheter 152.
Catheter 152 has a second lumen 182 that extends from auxiliary
device port 158 to distal end 184. Distal end 184 is located
proximal to distal end 172 of catheter 152. Slidably disposed
within second lumen 182 is a needle knife 186 that has a knife tip
188. Needle knife 186 is preferably of the endoscopic
electrosurgical type however any form of incision device that may
be operated to form an incision in tissue such as mechanical
cutters, water jets or lasers may be suitable.
[0055] Further, referring to FIG. 24, a dissecting instrument 270
is provided and includes a dissection catheter 272 having a distal
end 274 and a dissection balloon 276 having a large diameter
expanded dissection balloon configuration 276a that operates to
separates adjacent tissues. The dissection balloon 276 can be
non-compliant of the type generally known in the art or dissection
balloon 276 may be of the compliant or semi-compliant type. The
dissection balloon 276 may be formed from biocompatible polymer
types such as olefins, elastomers, thermoplastic elastomers,
vinyls, polyamides, polyimides, polyesters, fluropolymers,
copolymers and blends of any of the aforementioned. The dissection
catheter 272 has insertion markers 278 positioned along its shaft.
The proximal end of dissection catheter 272 includes both an
inflation port 280 that is in fluid communication with dissection
balloon 276, and a valve assembly 282.
[0056] In an embodiment seen from FIGS. 24 and 25, the dissecting
instrument 270 is provided with tunneling capability to operate as
a tunneling dissecting instrument. A tunneling catheter 284 is
slidably disposed through valve assembly 282 and extends within a
lumen of the dissection catheter 272. The tunneling catheter distal
end 286 may extend beyond the dissection catheter distal end 274.
Tunneling catheter 284 includes an inflation port 288 and valve
assembly 290. A tether slide member 292 is slidably disposed on
handle body 294 with distance markers 296. FIG. 26, illustrates a
detailed cross section of the distal portion of the tunneling
dissecting instrument 270. The distal end 298 and proximal end 300
of dissection balloon 276 are connected to the exterior of
dissection catheter 272. An inflation device connects to inflation
port 280 to inflate dissection balloon 276. Tunneling catheter 284
is slidably disposed within the lumen 306 of dissection catheter
272. Positioned within the lumen 308 of tunneling catheter 284
there is an everted expandable tunneling balloon 310. The tunneling
balloon 310 is preferably non-compliant of the type generally known
in the art, however, tunneling balloon 310 may be of the compliant
or semi-compliant type. The tunneling balloon 310 may be formed
from biocompatible polymer types such as olefins, elastomers,
thermoplastic elastomers, vinyls, polyamides, polyimides,
polyesters, fluropolymers, copolymers and blends of any of the
aforementioned. The distal end of tunneling balloon 310 is
connected to a tether member 312 which has a proximal end that is
connected to tether slide 292.
[0057] The operation of the tunneling dissecting instrument 270 to
form a tunnel and large dissected area is similar to the operation
of the separate instruments. The tunneling catheter 284 is
pressurized with fluid to linearly expand tunneling balloon 3 10.
The temperature of the tunneling balloon 310 may be modified, e.g.,
cooled, via the fluid introduced therein to reduce bleeding. Once a
tunnel has been formed, tunneling balloon 310 may be deflated and
dissection catheter 272 may be advanced through the opening into
the tunnel. The markers 278 may be used to determine the depth in
which the dissection catheter 272 has been advanced into the
tunnel. Once the dissection catheter 272 has been properly
positioned within the tunnel it may be operated. By applying
pressurized fluid to inflation port 280, dissection balloon 276 is
dilated to an expanded dissection balloon 276a configuration.
During the expansion, a dissected area is created. The temperature
of the dissection balloon 276 may be modified, e.g., cooled, via
the fluid used therein to reduce bleeding.
[0058] Other embodiments of tunneling and dissecting instruments
disclosed in U.S. Ser. No. 11/775,996 can also be used. Now with
reference to such tunneling and dissecting instruments, an exemplar
embodiment of a cholecystectomy procedure according to the
invention is now described. First, access is provided to the
peritoneal cavity using the access system, as described above.
[0059] Then, referring to FIG. 26, a preferably multilumen device
88 is inserted through the shaped port 14 to a location such that
the axis of a lumen of the device is directed between the
gallbladder 90 and the liver 92. Multilumen device 88 preferably
integrates an endoscope or includes a lumen for receiving an
endoscope. A needle knife 186 is advanced through the lumen of the
device 88 to define a small hole between the gallbladder 90 and
liver 92. A tunneling instrument 150 is advanced into the hole in
the tissue preferably through another lumen in the multilumen
device 88 (FIG. 27). The needle knife 186 and tunneling instrument
150 may be integrated. The tunneling instrument 150 is operated to
advance an elongate balloon member 154 to define an elongate tunnel
in the tissue between the gallbladder and the liver (FIG. 28). If
the tunneling instrument 150 is a separate instrument from the
dissecting instrument, it is removed from the tunnel so that the
dissecting instrument 270 can then be (and is) advanced into
through another lumen of the multilumen device and into the tunnel
(FIG. 29). The dissecting instrument 270 is then operated to expand
the dissection balloon 276 within the tunnel to separate the
tissues surrounding the balloon (FIG. 30).
[0060] Referring to FIGS. 31 through 35, the process is then
repeated with the needle knife 186, tunneling instrument 150, and
dissecting instrument 270 in different locations to substantially
fully separate the gallbladder 90 from the liver 92. If necessary,
an electrocautery knife, may be used to separate any remaining
connection tissue. The multilumen device 88 permits multiple
instrument use without requiring the physician to repeatedly change
out the instruments. Of course, two or more of the instruments may
be integrated into a single assembly. Further, the use of balloons
to dissect the gallbladder (rather than electrocautery) is
substantially safer and does not pose a threat to surrounding
viscera.
[0061] The gallbladder may be completely resected by utilizing
additional surgical instruments such ligators, electrocautery
knives, and scissors for sealing off and separation of the cystic
duct. The resected gallbladder may be placed in an endoscopically
delivered specimen retrieval bag using tissue graspers. Once the
gallbladder is secured in the retrieval bag, the bag may be
withdrawn through the port lumen with the endoscope. Alternatively,
if the specimen is too large for removal through the port, the
specimen may be positioned adjacent the port distal end and
withdrawn along with the port from the body.
[0062] Any instruments 150, 270, 184 remaining within the patient,
the multilumen device 88, and the pre-shaped port 14 are removed
from the overtube 12. Then the distal cuff 24 is deflated,
permitting retraction of the overtube into the stomach. The
proximal cuff 22 is also deflated. Appropriate instrumentation or
means are also used to close the hole in the stomach wall. For
example, clips, staples, sutures, other closures, ligatures and
ligating bands, etc., can be used. Also, closure means integrated
with the access system, as discussed below, can be integrated into
any of the access systems described herein. Further, the
instruments described can be used to perform dissections of other
organs adhered to the abdominal wall or dissections of other
tissues from organs. For example, the appendix can be removed by a
similar procedure.
[0063] Turning now to FIGS. 36 through 37, another embodiment of an
access system 410 according to the invention is shown. The access
system 410 includes an overtube 412, a preshaped port 414 coupled
at a distal end of the overtube (distal of cuff 424), and a handle
420 at a proximal end of the overtube 412. The overtube 412
includes a gastric wall securing system, preferably as described
with respect to access system 10, i.e. with cuffs 422, 424
expandable via injection ports 426, 428 at the handle 420.
[0064] As shown in FIGS. 36 and 37, the preshaped port 414 is
configured from a preferably unitary tubular element and most
preferably an extruded polymeric tube. Breaks, cuts or superficial
recesses 440 are provided along the tube to provide flexibility. A
silicone lining 442 covers both the outer surface of the tube to
prevent tissue from catching in the breaks. A silicone lining 444
may also be provided to the inner surface of the tube to provide a
smooth lumen for endoscope passage. One or more control elements
446, e.g., wires or cables, pass through respective conduits within
the tube wall. Each control element 446 has a distal end 448
coupled at a distal portion 450 of the tube 414 and a proximal end
that is coupled to an actuator, such as knob 452 on the handle 420.
When the actuator 452 is operated, the associated control element
446 is tensioned to cause the tube 414 to bend, e.g., up to
180.degree., along the breaks and to assume a preshape
configuration as shown in broken lines in FIG. 36A. The preshaped
port 414 can be maintained in such preshaped configuration to
orient an endoscope inserted through the overtube toward a target
tissue. If more than one control element is provided within the
access system for actuation of the preshaped port (e.g., three
control elements), more complex directional control of the
preshaped port 414 can be provided. It is appreciated that
additional actuators can be provided for each such control element.
If necessary to reconfigure the access port or at the conclusion of
the procedure, the handle 420 can be operated to release the
tension on the control element(s) 446 and straighten the preshaped
port 414 to aid in reconfiguring or withdrawing the access system
410 from the patient.
[0065] It is appreciated that because the preshaped port 414 is
operator manipulatable while within the patient's body, it has
steerability that is not provided with access system 1O. Thus,
while the use of access system 410 in a surgical procedure is
generally similar to access system 10, the integration of preshaped
port 414 with overtube 412 permits some differences.
[0066] As such, turning now to FIGS. 38 through 47, variations in a
surgical procedure with access system 410 relative to the procedure
previously described with access system 10 are now described. The
access system 410 is introduced into the stomach and advanced
adjacent the stomach wall (FIG. 38). An endoscope (not shown) is
preferably used within the access system 410 for visualization, but
the endoscope for this portion of the procedure is not required to
be steerable, as the preshaped port 414 can be actuated to steer
the assembly. In accord with an embodiment of the method, a
piercing catheter 70 is inserted into the patient's peritoneal
cavity 56 from outside the stomach wall 52, pierced through the
stomach wall 52, and introduced into the stomach 58 (FIGS. 39 and
40). A snare device 72 is introduced through the piercing catheter
70 and into the stomach 58. A balloon catheter 74 fixed along a
guidewire 76 is introduced into the stomach 58 through the
preshaped port 414 (FIG. 41).
[0067] The snare device 72 and cutting instrument 70 are operated
to grasp the guidewire 76 and/or balloon catheter 74, and pull the
balloon catheter 74 through the piercing 78 in the stomach wall 52
(FIGS. 41 and 42). Once the balloon 80 on the balloon catheter 74
is positioned within the piercing 78, the snare device 72 releases
the guidewire 76 and/or balloon catheter 74 so as to decouple the
snare device 72 from the balloon catheter 74, as shown in FIG.
43.
[0068] Alternatively, the cutting instrument can be advanced
through the access system and preshaped port thereof to define a
piercing 78 in the stomach wall 52 from the interior of the
stomach. The guidewire 76 and balloon catheter 74 are then advanced
through the piercing to position the balloon 80 within the piercing
78.
[0069] Then, once the balloon 80 is situated within the piercing,
the balloon is expanded upon activation from outside the patient by
pressurizing a fluid through the balloon catheter 74. The balloon
80 can be located partially inside the distal end 450 of the
preshaped port 414 or completely external the distal end of the
port. As the balloon 80 is expanded, the piercing is dilated to
create a hole 82 of sufficient size to receive the preshaped port
414 of the access system 410 (FIG. 44). The port 414 is advanced
through the hole 82 and then the distal end 425 of the overtube 412
is advanced up to the proximal cuff 422, which is expanded (FIG.
45). Then the distal cuff 424 is expanded to secure the access
system to the stomach wall 52 at the distal end 425 of the overtube
412 to the between the proximal and distal cuffs 422, 424 with the
preshaped port 414 extending within the peritoneal cavity 56 (FIG.
46).
[0070] The balloon 80 is deflated, and the balloon catheter 74 and
guide 76 are withdrawn from the access system 410. The preshaped
port 414 is then actuated from the handle 420 (FIGS. 36 and 38) to
cause the port to assume a curved or bent configuration. An
endoscope 60 and other instruments are then advanced through the
port 414 and directed to pertinent tissue, as previously described,
for performing and concluding a surgical procedure on tissue within
the peritoneal cavity (FIG. 47).
[0071] Referring now to FIGS. 48 and 48A, another embodiment of an
access system 710 is shown. The system includes an overtube 712, as
described above with respect to overtube 12, and a port 714. Port
714 includes a tubular member 742 having a proximal end defining
multiple lumen 743a, 743b. The distal end of port 714 divides at a
Y to include a plurality of pre-shaped tubular distal portions
744a, 744b, each similar to pre-shaped distal portion 44. Each
distal portion 744a, 744b is preferably associated with one of
lumen 743a, 743b. Each of the pre-shaped distal portions 744a, 744b
can be provided with a different shape to direct instruments
positioned therethrough toward anatomical structure.
[0072] Turning now to FIG. 49, another embodiment of an access
system 810 is shown. The system includes an overtube 812, as
described above with respect to overtube 12, and a plurality of
ports 814a, 814b positionable therethrough. Each port 814a, 814b is
generally similar to port 14, through smaller in diameter to permit
the multiple ports to be received within the overtube 812 at
once.
[0073] Referring now to FIG. 50, another embodiment of an access
system 910 is shown. The system includes an overtube 812 with a
plurality of preshaped port 814a, 814b coupled at a distal end of
the overtube, and a handle 820 at a proximal end of the overtube
812. The arrangement of system 810 is similar to system 410, with
multiple ports at the distal end of the overtube. The handle
includes two actuators 852a, 852b, to apply and release tension on
control elements extending from the handle to the distal end of the
respective ports to control shaping of the ports 814a, 814b into
respective predetermined shapes.
[0074] Turning now to FIGS. 51 and 52, another embodiment of an
access system 510 according to the invention is shown. The access
system includes an overtube 512 and a proximal handle 520. The
overtube 512 is provided with a gastric wall securing system
preferably as described above, i.e., with expandable proximal and
distal cuffs 522, 524 adjacent its distal end 525 and the requisite
structural and functional elements to effect such expansion and
contraction. The distal tip 525a is tapered to facilitate driving
insertion through the anatomical passageway and through the hole
created in the stomach wall, as previously described above
according to the method. In addition, the overtube 512 includes a
coil reinforcement 527 for lateral wall support. The overtube 512
may be used with or integrated with a preshaped port, as described
above. According to aspects of access system 510, the access system
is provided with a system (means) for insufflating/deflating the
peritoneal space separately from the gastric space, and a closure
system (means) integrated into the access system to close the hole
made in the intragastric wall in which the access system is secured
to seal the hole after the access system has been removed from the
hole. Either of such systems (means) may be individually provided
in any access system in accord with the invention.
[0075] Referring to FIGS. 51 and 52, the system to control
insufflation/deflation includes a seal and/or valve, collectively
560 and first and second ports 562, 564 extending at least
partially through the overtube. The seal/valve 560 is preferably a
self-sealing valve 560 within the lumen 518 of the overtube 512
(e.g., at the handle). The first port 562 is a pressure controlled
port extending from the handle 520 to an exit location 566
intermediate the handle 520 and the proximal cuff 522. The second
port 564 is a pressure controlled port extending from the handle
520 to an exit location 568 at or distal the distal cuff 524. The
handle 520 is also provided with a pressure control system 570 to
inject or evacuate air through the respective first and second
ports 562, 564. For example, control system 570 may include buttons
572a-d to activate injection or evacuation of air through each of
the first and second ports 562, 564 (four buttons 572a-d). The
pressure control system 570 preferably also includes monitoring
system 574 to monitor the pressure in at least one of, and
preferably both of, the stomach and the peritoneal cavity, and to
provide feedback of such pressure(s) to the access system
operator.
[0076] In use, once the access system has been secured to the
stomach wall to separate the intragastric space from the peritoneal
space, the pressures in the peritoneal space and stomach can be
separately controlled. With the access system so secured, the first
port exit 566 lies within the stomach and the second port exit 568
is located within the peritoneal cavity. In addition, the
esophageal sphincter forms a relatively air tight seal about the
exterior of the overtube 512. Air can then be evacuated from first
port 562, to reduce air pressure within the stomach, while air can
be injected to or maintained within the peritoneal cavity to
increase or maintain peritoneal pressure. The result will be that
the stomach will collapse to increase visibility at the surgical
site. Later, peritoneal air pressure can be decreased if desired or
the stomach air pressure can be increased as desired.
[0077] In addition, the access system 510 includes a closure system
that facilitates rapid closure of the hole 82 in the stomach wall
52 after removal of the overtube from the hole. (See, e.g., FIG.
17.) According to an exemplar embodiment, the closure system
generally includes a needle deployment and retraction system, a
tissue fastener deployment system able to deploy fasteners through
needles deployed in tissue, and a cinching mechanism adapted to
cinch the proximal ends of multiple tissue fasteners together to
close the hole in the tissue, as described hereinafter. The various
systems are preferably actuatable from discrete or integrated
actuators, e.g., levers 580, 582, 584 on the handle 520, or
instruments coupled to the handle or inserted through peripheral
lumen 576, 578 exterior to the central lumen 518 of the overtube
512. The actuators operate control members to operate effectors to
advance, retract, deploy and cinch, as required. The actuators are
coupled to control members required for such operations can be
those described in U.S. Pat. No. 6,824,548, U.S. Pub. No.
20040249395, U.S. Pub. No. 20050261708, U.S. Pub. No. 20060004409
and/or U.S. Pub. No. US2006/0004410 which are hereby incorporated
by reference herein in their entireties. Such patent and
publications describe flexible endoscopic instruments adapted to
provide significant pushing force at their distal ends, and the
mechanisms therein can be incorporated into the access system to
advance (and retract) one or more needles and fasteners in the
manner now described. In general, the actuators (e.g., levers) are
preferably coupled to the effectors (e.g. needle, push rod) in a
simple mechanical arrangement such that depression of a particular
lever causes the axial movement of the respective effector. For
instance a first actuator coupled to a needle may be actuated to
extend the needle from a lumen of the overtube to thereby pierce
tissue. A second actuator coupled to a pushrod, which is coaxially
positioned within the lumen of the needle, may be actuated to
advance the push rod axially within the needle lumen.
[0078] More particularly, referring to FIGS. 53 and 54, the access
system 510 includes at least one extendable hollow needle, and
preferably a plurality of extendable hollow needles 590, 592 from
its distal end 525. The needles 590, 592 are initially retracted
within the distal end 525 of the access system 510. Upon actuation
of an associated actuator 580, the needles 590, 592 are extended
from the distal end 525. As shown, the needles 590, 592 can then be
pierced through the stomach wall 52. This step is done prior to any
hole formation in the stomach wall 52 of sufficient size to permit
passage of the distal end 525 of overtube 512. It is appreciated
that a piercing instrument and grasper may optionally be inserted
from the peritoneal cavity into the stomach may be used in
conjunction with the access system to stabilize the distal end 525
during needle insertion.
[0079] Referring to FIGS. 54 and 55, after the needles 590, 592
have been inserted into the stomach wall 52 and while such needles
are within the stomach wall, the appropriate actuator 582 is
manipulated to axially advance a push rod 583 positioned within the
needle lumen to deploy fasteners 594, 596 through the needles 590,
592 so as to have a portion which extends through to the other side
of the stomach wall (within the peritoneal cavity 56). According to
a preferred aspect of the invention, the fasteners 594 are T-shaped
tags (in a deployed configuration) having a shaft 598 with a head
600 transverse to the shaft at one end, and an eye 602 or other
suture engaging structure at the other end. Suture material 604 is
coupled to the eye 602. The tag 594 (as shown in FIG. 54) is
collapsible into a pre-deployed configuration within each needle,
with the head 600 substantially parallel to the shaft 598 and
preferably retained within the needles (although the distal end of
the head may extend from the needle). Upon deployment, the tag 594
is forced out of the needle, head 600 first, through the stomach
wall (and onto the peritoneal side of the stomach wall), while the
shaft extends within the tissue and the suture material 604 remains
coupled to the access system. The tag 594 may assume a T-shape
after deployment by an inherent bias between the head 600 and shaft
598, or by retraction of the shaft 598 relative to the head 600.
T-shaped tags 594 of this design are described in detail in
previously incorporated U.S. Ser. No. 12/030,244. Other tag
configurations or fasteners could also be used. For example one
alternate tag configuration may be a modification of tag 594 in
which shaft 598 is formed entirely of suture material and coupled
directly to a mid portion of head 600. Multiple fasteners 594, 596
may be deployed at once through multiple needles 590, 592 provided
to the access system 510. Alternatively, where the access system
includes a single needle, individual fasteners may be deployed
sequentially using a single needle with a store of fasteners, with
the access system rotated between deployments for polar
displacement of the fasteners about a subsequent hole for the
distal end 525. After the fasteners have been deployed, a procedure
through the stomach wall is performed as described above. Referring
to FIG. 57, at the conclusion of the procedure, once the access
system is withdrawn from a hole in the stomach wall, the third
actuator 584 on the handle 520 is operated to pull on the suture
material 604 and cinch the fasteners 594, 596 together about the
hole 82 to close the hole. The T-shaped tag provides a small
profile aiding deployment and provides strong resistance to
pull-out during cinching. The suture material 604 of the fasteners
is then clipped, knotted or otherwise secured to maintain closure
of the hole. Preferably a cinch delivery assembly is used to grasp
the suture connecting the T-tags and pull the suture lines within
the cinch while drawing the T-tags and associated tissue into close
apposition thereby closing a hole. The cinch preferably contains a
one way mechanism such that the suture lines may be drawn taught
and not allow them to loosen. Various cinch designs such as those
described in U.S. Pat. App. Pub. Nos. 20040249395, 20050261708 and
20060004409 are suitable for performing the closure operation.
[0080] There have been described and illustrated herein several
embodiments of an access system and methods of performing
intra-abdominal surgery. While particular embodiments of the
invention have been described, it is not intended that the
invention be limited thereto, as it is intended that the invention
be as broad in scope as the art will allow and that the
specification be read likewise. Thus, while a particular gastric
wall securing system has been disclosed, it will be appreciated
that other gastric wall securing system can be used as well,
including mechanically expandable systems. In addition, while
particular types of instruments for the cutting and piercing
tissue, and drawing a balloon from the stomach cavity to within the
stomach wall have been disclosed, it will be understood that other
suitable instruments can be used as well. Also, while a preferred
system of tunneling and dissection balloons has been disclosed for
separation of the tissues within the abdomen, it will be recognized
that other tissue tunneling and/or dissection instruments can be
used instead. Furthermore, while an exemplar mechanism for
operating the closure system has been disclosed, it is understood
that other suitable mechanism and handles for operation thereof can
be similarly used. Moreover, while a T-shaped tag is preferred for
effecting closure of a hole through which the access system is
inserted, it is appreciated that other suitable fasteners can be
used as well. In addition, while the access system has been
described with respect to providing access from the intragastric
space to the peritoneal cavity through the stomach, it can likewise
be used through the anus and colon. Moreover, it can also be used
as an access system into the peritoneal space through the vagina.
It will therefore be appreciated by those skilled in the art that
yet other modifications could be made to the provided invention
without deviating from its spirit and scope as claimed.
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