U.S. patent application number 12/499023 was filed with the patent office on 2009-10-29 for apparatus and methods for performing mucosectomy.
This patent application is currently assigned to USGI MEDICAL, INC.. Invention is credited to Vahid Saadat, Lee L. Swanstrom.
Application Number | 20090270856 12/499023 |
Document ID | / |
Family ID | 46545964 |
Filed Date | 2009-10-29 |
United States Patent
Application |
20090270856 |
Kind Code |
A1 |
Saadat; Vahid ; et
al. |
October 29, 2009 |
APPARATUS AND METHODS FOR PERFORMING MUCOSECTOMY
Abstract
Apparatus and methods are provided for performing mucosectomy,
such as to map out gastrointestinal surgery, including endoluminal
gastric reduction. In one variation, tie apparatus comprises a
separating element and an integrated resection element. In one
variation, the apparatus is configured to simultaneously separate
mucosal tissue from underlying muscularis tissue and to resect the
separated mucosal tissue. Methods of using the apparatus are
provided.
Inventors: |
Saadat; Vahid; (Atherton,
CA) ; Swanstrom; Lee L.; (Portland, OR) |
Correspondence
Address: |
LEVINE BAGADE HAN LLP
2400 GENG ROAD, SUITE 120
PALO ALTO
CA
94303
US
|
Assignee: |
USGI MEDICAL, INC.
San Clemente
CA
|
Family ID: |
46545964 |
Appl. No.: |
12/499023 |
Filed: |
July 7, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11069890 |
Feb 28, 2005 |
7571729 |
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12499023 |
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10954658 |
Sep 29, 2004 |
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11069890 |
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10797910 |
Mar 9, 2004 |
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10954658 |
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Current U.S.
Class: |
606/33 ; 606/170;
606/185; 606/41 |
Current CPC
Class: |
A61B 90/39 20160201;
A61B 2018/00244 20130101; A61B 2017/06052 20130101; A61B 2018/1467
20130101; A61B 2090/3937 20160201; A61B 2018/144 20130101; A61B
2018/00982 20130101; A61B 2218/002 20130101; A61B 17/320016
20130101; A61B 18/1492 20130101; A61B 2018/00577 20130101; A61B
2090/036 20160201; A61B 2090/3912 20160201; A61B 2090/3991
20160201; A61B 2017/00269 20130101; A61B 17/3478 20130101; A61B
2017/308 20130101; A61B 2017/00349 20130101; A61B 2017/306
20130101; A61B 2018/1415 20130101; A61B 18/1482 20130101; A61B
2090/3908 20160201; A61B 17/3211 20130101; A61B 17/32075 20130101;
A61B 2090/395 20160201; A61B 2017/320044 20130101; A61B 18/14
20130101; A61B 2018/124 20130101; A61B 2017/00818 20130101; A61B
2017/00986 20130101; A61B 2017/0419 20130101; A61F 5/0013 20130101;
A61B 17/0401 20130101; A61B 17/0469 20130101; A61B 2018/00291
20130101; A61B 17/32053 20130101; A61B 2018/00029 20130101; A61B
2218/007 20130101; A61B 2018/00494 20130101; A61B 2018/00595
20130101; A61B 2090/3987 20160201; A61B 17/12013 20130101; A61B
2017/0411 20130101 |
Class at
Publication: |
606/33 ; 606/185;
606/170; 606/41 |
International
Class: |
A61B 17/32 20060101
A61B017/32; A61B 17/34 20060101 A61B017/34; A61B 18/18 20060101
A61B018/18; A61B 18/14 20060101 A61B018/14 |
Claims
1. Apparatus for separating and resecting mucosal tissue from an
interior of a patient's stomach, the apparatus comprising: an
elongated shaft having a lumen extending therethrough and having a
distal end, the distal end defining a channel; a hollow needle
extending from the distal end of the shaft, the needle being in
fluid communication with the lumen of the elongated shaft; and a
resection element disposed on the distal end of the shaft and
within the channel.
2. The apparatus of claim 1, wherein the elongated shaft is
sufficiently flexible for endoluminal advancement within a human
patient.
3. The apparatus of claim 1, wherein the elongated shaft is
sufficiently rigid for laparascopic advancement within a human
patient.
4. The apparatus of claim 1, wherein the needle defines a portion
of the channel.
5. The apparatus of claim 1, wherein the channel has a width that
substantially corresponds with the thickness of a layer of the
mucosal tissue of the patient's stomach.
6. The apparatus of claim 1, wherein the needle extends in a
proximal direction from the distal end of the shaft.
7. The apparatus of claim 1, wherein the needle extends in a distal
direction from the distal end of the shaft.
8. The apparatus of claim 1, wherein the needle is disposed at an
angle relative to the shaft.
9. The apparatus of claim 8, wherein the angle is an obtuse
angle.
10. The apparatus of claim 1, wherein the resection element is
configured to automatically engage mucosal tissue that has been
separated from underlying muscularis tissue via the hollow
needle.
11. The apparatus of claim 1, wherein the resection element is
chosen from the group consisting of energizable elements, RF
elements, wires, cutting elements, blades, dissectors, jaw members
and combinations thereof.
12. Apparatus for separating and resecting mucosal tissue from an
interior of a patient's stomach, the apparatus comprising: an
elongated shaft having a lumen extending therethrough and having a
distal end, the distal end defining a channel; a separating element
extending from the distal end of the shaft; and a resection element
disposed on the distal end of the shaft and within the channel.
13. The apparatus of claim 12, wherein the elongated shaft is
sufficiently flexible for endoluminal advancement within a human
patient.
14. The apparatus of claim 12, wherein the elongated shaft is
sufficiently rigid for laparascopic advancement within a human
patient.
15. The apparatus of claim 12, wherein the separating element
defines a portion of the channel.
16. The apparatus of claim 12, wherein the channel has a width that
substantially corresponds with the thickness of a layer of the
mucosal tissue of the patient's stomach.
17. The apparatus of claim 12, wherein the separating element
extends in a proximal direction from the distal end of the
shaft.
18. The apparatus of claim 12, wherein the separating element
extends in a distal direction from the distal end of the shaft.
19. The apparatus of claim 12, wherein the separating element is
disposed at an angle relative to the shaft.
20. The apparatus of claim 19, wherein the angle is an obtuse
angle.
21. The apparatus of claim 12, wherein the resection element is
configured to automatically engage mucosal tissue that has been
separated from underlying muscularis tissue via the separating
element.
22. The apparatus of claim 12, wherein the resection element is
chosen from the group consisting of energizable elements, RF
elements, wires, cutting elements, blades, dissectors, jaw members
and combinations thereof.
23. The apparatus of claim 12, wherein the separating element
comprises an inclined surface configured for placement within a
submucosal space between the mucosal tissue and underlying
muscularis tissue.
24. The apparatus of claim 12, wherein the separating element is
chosen from the group consisting of wedges, inclined planes,
inclined surfaces, shoe horns, fluid boluses, dissectors, jaw
members and combinations thereof.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of co-pending U.S. patent
application Ser. No. 11/069,890, filed on Feb. 28, 2005, which is a
continuation-in-part application of co-pending U.S. patent
application Ser. No. 10/954,658 filed Sep. 29, 2004, which is a
continuation-in-part application of co-pending U.S. patent
application Ser. No. 10/797,910 filed Mar. 9, 2004, the contents of
which are incorporated herein by reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to methods and apparatus for
performing mucosectomy. More particularly, the present invention
relates to methods and apparatus for mapping out gastrointestinal
("GI") surgery, such as endoluminal gastric reduction, via
mucosectomy.
[0004] Morbid obesity is a serious medical condition pervasive in
the United States and other countries. Its complications include
hypertension, diabetes, coronary artery disease, stroke, congestive
heart failure, multiple orthopedic problems and pulmonary
insufficiency with markedly decreased life expectancy.
[0005] Several open surgical techniques have been developed to
treat morbid obesity, e.g., bypassing an absorptive surface of the
small intestine, or reducing the stomach size. These procedures are
difficult to perform in morbidly obese patients because it is often
difficult to gain access to the digestive organs. In particular,
the layers of fat encountered in morbidly obese patients make
difficult direct exposure of the digestive organs with a wound
retractor, and standard laparoscopic trocars may be of inadequate
length. In addition, previously known open surgical procedures may
present numerous life-threatening post-operative complications, and
may cause atypical diarrhea, electrolytic imbalance, unpredictable
weight loss and reflux of nutritious chyme proximal to the site of
the anastomosis.
[0006] Applicant has previously described methods and apparatus for
laparoscopically reducing a patient's stomach, for example, in
co-pending U.S. patent application Ser. No. 10/8434,682, filed May
10, 2004, which is incorporated herein by reference. Furthermore,
Applicant has previously described methods and apparatus for
endoluminally reducing a patient's stomach, for example, in
co-pending U.S. patent application Ser. No. 10/735,030, filed Dec.
12, 2003, which also is incorporated herein by reference. Those
applications describe techniques for creating a small pouch from
within the patient's stomach that is positioned below the
gastroesopliageal junction to limit food intake and promote a
feeling of satiety. The endoluminal pouch is expected to act in a
manner similar to a Vertical Banded Gastroplasty ("VBG").
[0007] The gastrointestinal lumen includes four tissue layers,
wherein the mucosa layer is the top (innermost) tissue layer,
followed by connective tissue, the muscularis layer and the serosa
layer. One problem with endoluminal gastrointestinal reduction
systems is that the anchors (or staples) must engage at least the
muscularis tissue layer in order to provide a proper foundation,
since the mucosa and connective tissue layers tend to stretch
elastically tinder the tensile loads imposed by normal movement of
the stomach wall during ingestion and processing of food.
Applicant's previously-described techniques for stomach reduction
address this concern by reconfiguring the stomach lumen via
engagement of at least the muscularis layer of tissue.
[0008] It is expected that proper placement of anchors or suture to
achieve such stomach reduction will present significant challenges
to a medical practitioner, due, for example, to the limited working
space, as well as the limited visualization provided by an
endoscope or fiberscope. U.S. Pat. No. 6,558,400 to Deem et al.
describes methods and apparatus for marking the interior of the
stomach from the esophagus to the pylorus to map out an
endolutninal reduction procedure. Marking is achieved with dye
channeled through ports in a marking device or bougie. The bougie
optionally may comprise suction ports for evacuating the stomach
about the bougie, at which point the dye may be injected to stain
the stomach along points that contact the dye ports. The stomach
then may be insulated for performing the endoscopic reduction
procedure utilizing the map provided by the dye marks stained onto
the stomach mucosa.
[0009] A significant drawback of the marking technique described by
Deem et al. is that dyes have a tendency to spread and are
difficult to localize, especially in a fluid environment such as
that which contacts the mucosa layer of the stomach. As such, it is
expected that dye that does not penetrate beyond the mucosa will
provide an inaccurate and/or unstable map for performing endoscopic
gastric reduction. This, in turn, may yield an incorrectly sized or
poorly sealed stomach pouch, which may render the procedure
ineffective in facilitating weight loss and/or may result in
dangerous complications.
[0010] In view of the aforementioned limitations, it would be
desirable to provide methods and apparatus for mapping out
endoluminal gastrointestinal surgery that may be readily localized,
that enhance accuracy and stability of the surgical map, that
facilitate direct engagement of muscularis tissue from within the
stomach and/or that initiate a wound healing response along
approximated tissue.
BRIEF SUMMARY OF THE INVENTION
[0011] In view of the foregoing, the present invention provides
apparatus and methods for marking the interior of a patient's
gastrointestinal lumen. In a first variation, the surgical map
comprises localized RF scarring or mucosal ablation. In an
alternative variation, the map comprises pegs, e.g. colored pegs,
which may be biodegradable, e.g. fabricated from polyglycolic acid.
Alternatively, the pegs may comprise one or more corkscrews
advanced into tissue surrounding the GI lumen. In yet another
alternative variation, the map comprises dye injected into at least
the submucosa. The dye may be fluorescent or of varying colors.
Alternatively, the dye may be disposed within nanospheres or
microspheres implanted submucosally. In addition, or as an
alternative,. to dye spheres, the spheres may be magnetic,
heat-able ferromagnetic or Curie point, plastic and inert,
radiopaque, etc. As a still further alternative, the map may
comprise the shaft of an endoluminal surgical tool having specified
dimensions and/or color-coding, etc. In another alternative
variation, the map may be formed from surgical mesh. Additional
mapping apparatus will be apparent.
[0012] In one preferred variation, placement of the map is
accurately achieved using suction ports and/or an inflatable member
disposed along an endoluminal support, such as a shaft or other
tool associated with the endoluminal GI surgery. When using
suction, the stomach may be deflated about the support prior to
deployment of the surgical map. When using an inflatable member,
the inflatable member may be inflated to contact tissue prior to
deployment of the map. As will be apparent, a combination of
suction and inflation may be used to properly orient tissue prior
to mapping.
[0013] In additional variations, mucosectomy and/or mucosal
ablation is performed to map out endoluminal GI surgery, to
facilitate direct endoluminal engagement of underlying muscularis
tissue and/or to initiate a wound healing response. Specialized
apparatus may be provided to achieve desired spacing and/or
positioning of tissue markings, and may be provided to actually
form the markings.
[0014] Methods of using apparatus of the present invention also are
provided.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The above and other objects and advantages of the present
invention will be apparent upon consideration of the following
detailed description, taken in conjunction with the accompanying
drawings, in which like reference characters refer to like parts
throughout, and in which:
[0016] FIG. 1 is an isometric view of a first variation of
apparatus of the present invention configured to map out an
endoluminal gastrointestinal surgery, the apparatus comprising
suction ports and RF elements configured to selectively scar or
ablate the interior wall of the GI lumen;
[0017] FIGS. 2A-2C are, respectively, a side view, partially in
section; a cross-sectional detail view along view line A-A in FIG.
2A; and a side-sectional view along view line B-B of FIG. 2A;
illustrating a method of using the apparatus of FIG. I to map out
an endoscopic stomach reduction procedure;
[0018] FIG. 3 is a schematic view of an alternative variation of
the apparatus of FIG. 1 that is configured to engage tissue via an
inflatable member;
[0019] FIGS. 4A-4C are schematic views of alternative apparatus for
mapping out an endoluminal GI surgery with pegs;
[0020] FIG. 5 is a schematic view of additional alternative
apparatus for mapping out an endoluminal GI surgery, the apparatus
comprising a catheter configured to locally deliver a marking
element at least submucosally;
[0021] FIGS. 6A and 6B are, respectively, a side view and a side
detail view, both partially in section, illustrating a method of
using the apparatus of FIG. 5 to map out an endoluminal GI
surgery;
[0022] FIGS. 7A-7D are, respectively, a side view, partially in
section; side-sectional detail views along section line C-C in FIG.
7A; and a side-sectional view; illustrating a method of mapping out
an endoluminal GI surgery with the shaft of an endoluminal surgical
tool having specified characteristics;
[0023] FIGS. 8A-8C are, respectively, a side view, partially in
section; a cross-sectional detail view along section line D-D in
FIG. 8A; and a side-sectional view along section line E-E in FIG.
8A, illustrating a method of mapping out endoluminal GI surgery
with surgical mesh;
[0024] FIG. 9 is a side view, partially in section, illustrating a
method of mapping out endoluminal GI surgery with an RF marking
element disposed on an inflatable member;
[0025] FIG. 10 is a schematic rear cut-away view, illustrating a
method of mapping out endoluminal GI surgery that facilitates
alignment of co-planar anterior and posterior tissue points;
[0026] FIGS. 11A and 11B are schematic detail views of tissue
marking apparatus configured to pierce and coagulate tissue;
[0027] FIG. 12 is a detail schematic view illustrating a method of
utilizing the apparatus of FIG. 11 to mark tissue;
[0028] FIGS. 13A and 13B are schematic views of variations of the
apparatus of FIG. 11 comprising irrigation;
[0029] FIGS. 14A and 14B are schematic and schematic detail views
of multi-point tissue marking apparatus configured to ablate and/or
weld tissue;
[0030] FIG. 15 is schematic side-sectional view illustrating a
method of using the apparatus of FIG. 14 to mark and weld
tissue;
[0031] FIG. 16 is a schematic view illustrating a method of marking
tissue with apparatus configured for plug mucosectomy and
electrocautery;
[0032] FIG. 17 is a schematic side view of a variation of the
apparatus of FIG. 16 comprising irrigation;
[0033] FIG. 18 is a schematic view of another variation of the
apparatus of FIG. 16 comprising a cutting wire;
[0034] FIGS. 19A-19C are schematic views of variations of the
apparatus of FIG. 18 comprising depth-limiting elements;
[0035] FIGS. 20A-20H are a schematic rear cut-away view, a
side-sectional view, detail schematic side sectional views and a
detail schematic isometric sectional view, illustrating a method of
using the apparatus of FIGS. 16-19 to map out endoluminal GI
surgery, to facilitate direct engagement of muscularis, and to
perform endoluminal gastric reduction or partition;
[0036] FIG. 21 is a schematic side view of a hemostasis catheter
used in combination with the apparatus of 16-19;
[0037] FIGS. 22A-22D are schematic views of apparatus comprising
removable and/or interchangeable/exchangeable heads for performing
medical procedures;
[0038] FIGS. 23A and 23B are schematic side and side cut-away
views, respectively, illustrating methods of using mucosectomy
apparatus comprising an actuable cutting wire to remove mucosal
tissue;
[0039] FIGS. 24A and 24B are schematic views of a suction
engagement variation of the apparatus of FIG. 23;
[0040] FIGS. 25A and 25B are schematic side views, illustrating a
method of using a side-suction engagement variation of the
apparatus of FIG. 23 to perform mucosectomy;
[0041] FIGS. 26A and 26B are, respectively, side cut-away and side
views, partially in section, illustrating a method of performing
mucosectomy with a rotating energizable wire variation of the
apparatus of FIG. 23;
[0042] FIG. 27 is a schematic side view of energizable biopsy
apparatus comprising suction;
[0043] FIGS. 28A-28C are schematic views illustrating variations of
measuring apparatus configured for mapping out endoluminal GI
surgery;
[0044] FIGS. 29A and 29B are, respectively, a schematic side view,
partially in section, and a cross-sectional view along section line
E-E of FIG. 29A, illustrating a laparoscopic endoluminal method of
using another variation of the apparatus of FIG. 28 to map out
endoluminal GI surgery;
[0045] FIGS. 30A and 30B are schematic side views, partially in
section, illustrating a fully endoluminal method of using the
apparatus of FIG. 29 to map out endoluminal GI surgery;
[0046] FIGS. 31A and 31B are schematic views of combination
measurement and mucosectomy apparatus shown, respectively, in a
collapsed delivery configuration and an expanded deployed
configuration;
[0047] FIG. 32 is a schematic view of centerline marking
apparatus;
[0048] FIGS. 33A and 33B are, respectively, a schematic side view,
partially in section, and a schematic rear cut-away view,
illustrating a method of using the apparatus of FIG. 32 to mark a
centerline within a patient's stomach for mapping out endoluminal
GI surgery;
[0049] FIGS. 34A and 34B are schematic detail views illustrating a
method of using a variation of the apparatus of FIG. 31 in
combination with the centerline markings of FIG. 33B to map out
endoluminal GI surgery;
[0050] FIG. 35 is a schematic rear cut-away view illustration a
method of mapping out endoluminal GI surgery and facilitating
direct muscularis engagement through plug mucosectomy, while
promoting wound healing response post-surgery through strip
mucosectomy;
[0051] FIGS. 36A and 36B are schematic views illustrating a method
and apparatus for forming a strip mucosectomy from a series of plug
mucosectomies; and
[0052] FIG. 37 is a schematic view of additional apparatus for
forming a strip mucosectomy.
[0053] FIGS. 38A and 38B are schematic views of additional
variations of apparatus for performing mucosectomy.
[0054] FIGS. 39A and 39B are exploded and assembly views,
respectively, of another variation of apparatus for performing
tissue marking and/or mucosectomy.
[0055] FIGS. 40A and 40B are side views partially in section,
illustrating a method of utilizing the apparatus of FIG. 39 to
separate mucosal tissue from underlying muscularis tissue.
[0056] FIG. 41 is a schematic view illustrating a method of
separating mucosal tissue from underlying muscularis tissue along a
line.
[0057] FIG. 42 is a schematic view of integrated apparatus for
separating mucosal tissue from underlying muscularis tissue, and
for resecting the separated mucosal tissue.
[0058] FIGS. 43A-43C are schematic views illustrating a method of
using the apparatus of FIG. 42 to resect mucosa.
[0059] FIG. 44 is a schematic view of a variation of the apparatus
of FIG. 42.
[0060] FIG. 45 is a schematic view illustrating a method of using
the apparatus of FIG. 44 to resect mucosa.
[0061] FIGS. 46A-B are a schematic views of another variation of
the apparatus of FIG. 42.
[0062] FIG. 47 is a schematic view of yet another variation of
integrated mucosal separation and resection apparatus.
[0063] FIG. 48 is a schematic view illustrating a method of using
the apparatus of FIG. 47.
[0064] FIG. 49 is a schematic view of integrated mucosal separation
and resection apparatus comprising a dissector.
[0065] FIGS. 50A and 50B are schematic views illustrating a method
of using the apparatus of FIG. 49.
[0066] FIGS. 51A and 51B are, respectively, a schematic side view
and a schematic detail view along section line A-A of FIG. 51A, of
another variation of integrated mucosal separation and resection
apparatus.
[0067] FIG. 52 is a schematic view illustrating a method of using
the apparatus of FIG. 51.
DETAILED DESCRIPTION OF THE INVENTION
[0068] The present invention relates to methods and apparatus for
mapping out endoluminal gastrointestinal ("GI") surgery. More
particularly, the present invention relates to methods and
apparatus for mapping out endoluminal gastric reduction.
[0069] Applicant has previously described methods and apparatus for
endoluminally forming and securing GI tissue folds, for example, in
U.S. patent application Ser. No. 10/735,030, filed Dec. 12, 2003,
which has been incorporated herein by reference. Such methods and
apparatus may be used to reduce or partition the effective
cross-sectional area of a GI lumen, e.g., to treat obesity by
approximating the walls of the stomach to narrow the stomach lumen
and/or create a pouch or endoluminal Vertical Banded Gastroplasty
("VBG"), thus promoting a feeling of satiety and reducing the area
for food absorption. However, as discussed previously, it is
expected that proper placement of anchors or suture to form and
secure such endoluminal VBG will present significant challenges to
a medical practitioner, due, for example, to the limited working
space, as well as the limited visualization provided by, e.g., an
endoscope or fiberscope.
[0070] Referring now to FIG. 1, a first variation of apparatus for
mapping out endoluminal GI surgery in accordance with the present
invention is described. Apparatus 10 comprises endoluminal support
12 having shaft 14 with one or more, e.g., a plurality, of suction
ports 16 and one or more, e.g., a plurality, of radiofrequency
("RF") marking electrodes 18 disposed along the length of the
shaft. Suction ports 16 are proximally coupled to suction pump 20
via tubing 22. Likewise, each RF marking electrode 18 is connected
to switching station 30 via a wire 32. As seen in FIG. 1, wires 32
optionally may be routed through tubing 22 over at least a portion
of their length. Switching station 30 comprises electrical contacts
34 that are electrically connected to RF marking electrodes 18 via
wires 32. Apparatus 10 further comprises RF generator 40, which is
configured to actuate electrodes 18 via switching station 30. RF
generator 40 comprises positive electrode 42 and negative or ground
electrode 44. RF generator 40 may comprise a commercially available
RF generator, per se known, for example, such as those distributed
by Everest Medical of Maple Grove, Minn.
[0071] In use, endoluminal support 12 may be endoluminally advanced
within a GI lumen, e.g., a patient's stomach. Actuation of suction
pump 20 from outside the patient draws suction through tubing 22
and suction ports 16, thereby bringing luminal GI tissue into
contact with shaft 14 of endoluminal support 12. Meanwhile,
negative electrode 44 of RF generator 40 may be placed exterior to
the patient, e.g., on the patient's chest, or on a metal operating
table just under the patient's back while the patient lies on the
table. As will be apparent, negative electrode 44. alternatively
may be coupled to endoluminal support 12, for example, along shaft
14 at a location radially distant from RF electrodes 18. Positive
electrode 42 may be selectively connected to any of the plurality
of electrical contacts 34 of switching station 30, as desired, to
actuate specified RF marking electrodes 18.
[0072] Actuation of electrodes 18 via RF generator 40 acts to
locally burn, singe, cut, ablate, scar or otherwise injure tissue
in contact with the electrodes along shaft 14 of endoluminal
support 12, thereby leaving identifiable marks on the surface of
the tissue that. may be used to map out an endoluminal GI surgery.
As will be apparent to those of skill in the art, the pattern of
electrodes 18 and suction ports 16 about shaft 14 of endoluminal
support 12 may be altered as desired to facilitate formation of
surgical maps having varying characteristics. Likewise, the shape
or orientation of shaft 14 may be altered.
[0073] Switching station 30 facilitates actuation of individual
electrodes 18, as well as actuation of any combination of the
individual electrodes, including simultaneous actuation of all the
electrodes. Such selective actuation is dependent upon which
electrical contact(s) 34 are connected to positive electrode 42 of
RF generator 40 when the generator is energized. As will be
apparent, switching station 30 optionally may be omitted, and wires
32 may couple RF electrodes 18 directly to RF generator 40.
[0074] Endoluminal support 12 optionally may comprise one or more
working lumens (not shown) for advancing additional surgical
instruments through the endoluminal support. Additionally or
alternatively, endoluminal support 12 optionally may comprise
proximal shaft 13 that is steerable and/or rigidizable or
shape-lockable, e.g. via pull wires actuated through handle 11.
Rigidizable shafts are described, for example, in Applicant's
co-pending U.S. patent application Ser. No. 10/735,030, filed Dec.
12, 2003, which has been incorporated herein by reference. When
utilizing a steerable, rigidizable shaft, endoluminal support 12
may be steered into proper position within a GI lumen, rigidized to
maintain its position, and then actuated as described above to mark
tissue and map out endoluminal GI surgery.
[0075] With reference now to FIG. 2, in conjunction with FIG. 1, a
method of using the apparatus of FIG. 1 to map out an endoscopic
stomach reduction procedure is described. In FIG. 2A, endoluminal
support 12 of apparatus 10 is endoluminally advanced down a
patient's throat into the patient's stomach S. Suction ports 16 and
RF electrodes 18 are oriented towards the greater curvature of
stomach S. Negative electrode 44 of RF generator 40 is placed
exterior to the patient in close proximity to shaft 14 of apparatus
10 (not shown). Suction pump 20 is then actuated to pull suction
through suction ports 16 and deflate the stomach about shaft 14 of
endoluminal support 12, as in FIG. 2B. Positive electrode 42 of RF
generator 40 is connected to one or more electrical contacts 34 of
switching station 30, and the RF generator is actuated to locally
mark the interior wall of stomach S with marks M at locations in
contact with actuated electrodes 18.
[0076] Once RF electrodes 18 have been actuated in a desired
pattern and for a desired duration at a desired intensity, RF
generator 40 is turned off and/or positive electrode 42 is
disconnected from switching station 30. As seen in FIG. 2C, stomach
S then may be insufflated, e.g., via air injected through suction
ports 16. Marks M burned or ablated into the mucosa of the stomach
may be used as a map for performing endoluminal stomach reduction,
for example, as described in Applicant's co-pending U.S. patent
application Ser. No. 10/735,030.
[0077] Referring now to FIG. 3, an alternative variation of
apparatus 10 is described wherein the suction elements have been
replaced with inflatable elements. Endoluminal support 12' of
apparatus 10' comprises inflatable member 50 coupled to shaft 14'.
Inflatable member 50 is illustratively shown at least partially
inflated in FIG. 3. RF electrodes 18 are coupled to the exterior of
the inflatable member in an appropriate pattern, and tubing 22
couples inflatable member 50 to inflation source 60, e.g., a
compressor or a syringe. In FIG. 3, switching station 30 has been
eliminated, and RF electrodes 18 have been connected directly to
positive electrode 42 of RF generator 40 via wire(s) 32. In this
manner, actuation of RF generator 40 energizes all electrodes 18
simultaneously.
[0078] In use, endoluminal support 12' is endoluminally advanced
within a patient's stomach and/or GI lumen. Inflatable member 50 is
inflated via inflation medium transferred from source 60 through
tubing 22 to the inflatable member. The inflatable member conforms
to the interior profile of the GI lumen, thereby bringing RF
electrodes 18 into contact with the interior wall of the lumen. The
electrodes then may be actuated as described previously to form
marks M for mapping out an endoluminal GI surgery. As will be
apparent, a combination of suction and inflation may be used to
properly orient tissue prior to marking and mapping.
[0079] Referring now to FIG. 4, alternative apparatus for mapping
out an endoluminal GI surgery is described. As seen in FIG. 4A,
apparatus 100 comprises a plurality of pegs 110 that are configured
to engage tissue and act as a map for endoluminal GI surgery. The
pegs optionally may comprise sharpened distal ends 112 configured
to penetrate tissue. Pegs 110 may also comprise optional barbs,
hooks, etc. 113 to maintain the pegs in the tissue after
penetration. The pegs may be endoluminally implanted at appropriate
locations, then visualized to provide a map for the GI surgery.
They preferably are colored to enhance visibility, and optionally
may be provided in a variety of colors, shapes, sizes, etc. to
provide additional mapping information. Pegs 110 preferably are
biodegradable, e.g., fabricated from polyglycolic acid. Pegs 110
optionally may comprise a plurality of corkscrews 120. Corkscrews
may require less force to advance into tissue, as compared to pegs
with substantially straight shafts having sharpened distal ends
112. The rotational motion used to advance corkscrews applies
enhanced force within the plane of tissue, as opposed to
perpendicular to the plane. As an alternative to corkscrews, screws
130 may be provided. Alternatively tacks 140 may be provided.
Additional pegs will be apparent.
[0080] FIGS. 4B and 4C illustrate modified variations of previously
described apparatus 10 and 10', respectively, that are configured
to deliver and deploy pegs 110 of apparatus 100. In FIG. 4B,
apparatus 150 comprises endoluminal support 152 having suction
ports 156 disposed along shaft 154. Suction ports 156 are coupled
to suction pump 20 via tubing 22, as described previously. Pegs 110
are disposed in channels 158 along shaft 154 and may be deployed
from the channels into tissue when tissue is disposed about the
shaft, e.g., via suction drawn through ports 156. Advancement of
the pegs into tissue may be achieved via pushrods, e.g. torque-able
pushrods (not shown). In FIG. 4B, a few pegs illustratively are
shown advanced out of channels 158.
[0081] In FIG. 4C, apparatus 200 comprises endoluminal support 202
having inflatable member 206 disposed along shaft 204. Pegs 110 are
lightly adhered to the surface of inflatable member 206, such that
the pegs may engage tissue and decouple from the inflatable member
upon inflation of the inflatable member into contact with the
tissue. Various mechanisms may be provided for releasably securing
pegs 110 to the surface of inflatable member 206, for example,
adhesives, electromagnets, fuse mechanisms, etc.
[0082] With reference now to FIG. 5, alternative apparatus for
mapping out an endoluminal GI surgery is described, the apparatus
comprising a marking element in combination with a catheter
configured to locally deliver the marking element at least
submucosally. Apparatus 300 comprises endoluminal support 302
having suction ports 306 disposed along shaft 304. Suction ports
306 are coupled to suction pump 20 via tubing 22, as described
previously. Apparatus 300 further comprises injection channels 308
having retractable needles 310. Needles 310 are illustratively
shown at least partially extended in FIG. 5.
[0083] In use, endoluminal support 302 may be advanced within a GI
lumen with needles 310 retracted. Suction then may be drawn through
ports 306 to bring tissue into proximity with channels 308. Needles
310 then may be extended into the tissue to penetrate the tissue.
When conducting endoluminal gastric procedures, the needles are
configured to penetrate the tissue at least submucosally. Upon
penetration of tissue by needles 310, marking elements may be
injected into the tissue below the surface through the needles.
[0084] Illustrative subsurface or submucosal marking elements
include, but are not limited to, dyes, fluorescent dyes and colored
dyes. As described in U.S. Pat. No. 6,558,400 to Deem et al., which
is incorporated herein by reference, marking dyes may comprise, for
example, methylene blue, thionine, acridine orange, acridine
yellow, acriflavine, quinacrine and its derivatives, brilliant
green, gentian violet, crystal violet, triphenyl methane, bis
naphthalene, trypan blue, and trypan red. U.S. Pat. No. 6,558,400
describes using these dyes to mark or stain the interior lining of
the stomach. However, that reference does not describe injecting
such dyes submucosally. Submucosal injection is expected to enhance
localization, stability and accuracy, as compared to mucosal
staining. Additional dyes that may be utilized include black ink
and India ink, as well as various combinations of dyes.
[0085] Additional subsurface/submucosal marking elements include,
for example, saline or bulking agents, e.g. collagen, to achieve
geometric marking/mapping via localized protrusion of the mucosa.
As yet another alternative, nanospheres or microspheres may be
utilized, e.g. colored spheres or dye-filled spheres. In addition,
or as an alternative, to dye spheres, the spheres may be magnetic,
heat-able ferromagnetic or Curie point, plastic and inert,
bioresorbable, radiopaque, etc. Curie point materials may be heated
to a known temperature via an external electromagnetic field, for
example, to cause local ablation, inflammation or scar formation,
mucosectomy, etc. Such local marking may be used to map out an
endoluminal GI surgery.
[0086] With reference now to FIG. 6, a method of using the
apparatus of FIG. 5 to map out an endoluminal stomach reduction is
described. In FIG. 6A, endoluminal support 302 of apparatus 300 is
endoluminally advanced down a patient's throat into the patient's
stomach S. Suction ports 306 and injection channels 308, having
needles 310 retracted therein, are oriented towards the greater
curvature of stomach S. Suction pump 20 is actuated to pull suction
through suction ports 306 and deflate the stomach about shaft 304
of endoluminal support 302. Needles 310 are advanced out of
injection channels 308 to penetrate tissue in proximity to the
channels, as seen in FIG. 6B. The distal tips of needles 310 are
disposed submucosally. Marking elements 320, which may comprise
dye, spheres, etc., are injected submucosally through needles 310,
thereby locally and submucosally marking the interior wall of
stomach S with marks M at locations penetrated by the needles.
Needles 310 are removed from the wall of stomach S, and suction
pump 20 is deactivated, leaving a map of marks M within the wall of
the stomach for endoluminal gastric reduction.
[0087] Referring now to FIG. 7, a method of mapping out an
endoluminal gastric reduction with the shaft of an endoluminal
surgical tool having specified dimensions and/or color-coding is
described. Apparatus 400 comprises surgical tool 402 having shaft
404 of specified dimensions appropriate for forming an endoluminal
VBG, for example, a diameter of about 1 cm. Shaft 404 optionally
may also comprise a plurality of variously colored or patterned
sections to provide additional mapping instructions or guideposts
for a medical practitioner. In FIG. 7, shaft 404 illustratively
comprises first and second sections 406a and 406b having different
surface patterns.
[0088] In FIG. 7A, shaft 404 is disposed in stomach S inferior to
the patient's gastroesophageal junction GE. In FIG. 7B, anterior An
and posterior Po tissue ridges are formed on either side of shaft
404, for example, utilizing apparatus and methods described in
Applicant's co-pending U.S. patent application Ser. No. 10/735,030,
which is incorporated herein by reference. The ridges are then
wrapped around shaft 404 and secured to one another, as in FIG. 7C.
In FIG. 7D, removal of shaft 404 leaves pouch P in stomach S,
thereby completing endoluminal VBG. Apparatus 400 maps out the
endoluminal VBG procedure by providing the medical practitioner
with visual cues as to proper location for formation of the
anterior and posterior ridges, as well as proper sizing for pouch P
upon approximation of the ridges.
[0089] With reference to FIG. 8, a method of using surgical mesh to
map out endoluminal GI surgery is described. In FIG. 8, apparatus
150 and pegs 110 of FIG. 4 are used in conjunction with surgical
mesh strips 500, which are coupled to pegs 110 disposed in channels
158. As seen in FIG. 8A, endoluminal support 152 of apparatus 150
is advanced into a patient's stomach S. Suction is then drawn
through ports 156 via pump 20, such that the stomach deflates about
shaft 154 of device 152, as seen in FIG. 8B. Pegs 110 are advanced
out of channels 158 into the wall of the stomach, thereby tacking
surgical mesh strips 500 to the wall. As seen in FIG. 8C, suction
is deactivated and apparatus 150 is removed from the patient,
leaving strips 500 as a surgical map disposed on the anterior and
posterior of stomach S. The strips may be used to map out the
formation of ridges and a pouch in a manner similar to that
described with respect to FIG. 7.
[0090] With reference to FIG. 9, a method of mapping out
endoluminal gastric reduction or restriction with an RF marking
electrode disposed on an inflatable member is described. In FIG. 9,
apparatus 600 comprises endoluminal support 605 having inflatable
member 610 with positive RF marking electrode 620 disposed in a
ring about the surface of the balloon. Ring electrode 320
preferably is flexible and painted on the exterior of inflatable
member 610, for example, with a conductive paint, such as a silver
paint. In this manner, electrode 620 may accommodate changes in
dimension as inflatable member 610 is inflated or deflated.
[0091] Inflatable member 610 is coupled to an inflation source,
such as previously described inflation source 60 of FIG. 3, for
inflating and deflating the member. Furthermore, RF marking
electrode 620 is electrically connected to an RF generator, such as
RF generator 40 of FIG. 3, which further is coupled to a negative
electrode, e.g. electrode 44 of FIG. 3, that preferably is disposed
external to the patient. Suction elements also may be provided, for
example, suction ports 16 in communication with suction pump 20, as
in FIG. 1.
[0092] In FIG. 9, endoluminal support 605 of apparatus 600 has been
advanced endoluminally through esophagus E into stomach S.
Inflatable member 610 then has been inflated, e.g. via inflation
source 60, with a known fluid volume. Endoluminal support 605 has
been retracted proximally until inflatable member 610 abuts
gastroesophageal junction GE.
[0093] Ring electrode 620 then is activated, e.g. via RF generator
40, to locally singe, burn or otherwise mark the interior of
stomach S. After marking, electrode 620 is deactivated, inflatable
member 610 is deflated, and endoluminal support 605 of apparatus
600 is removed from stomach S, thereby leaving a map within the
stomach for conducting endoluminal gastric reduction or
restriction. Advantageously, the volume of fluid disposed in upper
left portion 612 of inflatable member 610 (the portion of the
inflatable member disposed proximal of marking electrode 620)
during activation of electrode 620 substantially defines the mapped
out volume of a pouch that may be formed utilizing the map provided
by apparatus 600. In this manner, a stomach pouch of specified
volume may be accurately formed. As will be apparent, prior to
marking stomach S via activation of electrode 620, the stomach
optionally may be deflated, e.g., via suction, in order to better
approximate stomach tissue against inflatable member 610 and
electrode 620.
[0094] Referring now to FIG. 10, a method of mapping out
endoluminal GI surgery that facilitates alignment of co-planar
anterior and posterior tissue points is described. As seen in FIG.
10, two rows of marks M may be formed to mark the posterior Po and
anterior An positions for tissue approximation to form, e.g., a
pouch within a patient's stomach S. Marks M, which may be formed
utilizing any of the techniques described previously or via any
other technique, illustratively comprise alternating single marks
M.sub.1 and double marks M.sub.2. During approximation of posterior
and anterior tissue to form a tissue pouch, e.g., during formation
and approximation of posterior and anterior tissue folds around
bougie 750 advanced through esophagus E into stomach S, marks
M.sub.1 and M.sub.2 may provide a medical practitioner with visual
indicators for proper placement of tissue anchors and/or suture.
Furthermore, the alternating pattern of the marks may reduce a risk
of inadvertently approximating posterior and anterior tissue
segments disposed in different planes. Like properly buttoning a
shirt, the marks may ensure that the right `buttons` and `holes`
are aligned, i.e. that co-planar anterior and posterior tissue
points are approximated, rather than opposing tissue points that
are out of plane. Marks M.sub.1 and M.sub.2 may comprise any
variety of shapes, e.g., circles, ellipses, etc., which are
suitable for the purposes described above. Moreover, any number of
marks along a single row, e.g., anterior An, may be utilized in a
variety of patterns provided that the marks along the opposing row,
e.g., posterior Po, are complementary so that marks M.sub.1 and
M.sub.2 may be appropriately aligned and approximated.
[0095] With reference to FIG. 11, variations of tissue marking
apparatus configured to pierce and coagulate tissue are described.
In FIG. 11A, apparatus 700 comprises piercing element 702 extending
from coagulator tip 704. Both tip 704 and element 702 may be
energizable, either separately or in combination, in order to
locally cut, ablate, scar, burn, singe, coagulate, or otherwise
injure tissue with which they come into contact. The tip and/or
piercing element may, for example, be energized via RF generator
40. Optionally, tip 704 and element 702 may comprise a bipolar
electrode pair. Alternatively, each may be monopolar or may
individually comprise bipolar elements. FIG. 11B illustrates an
alternative variation of apparatus 700 having alternative piercing
element 702' that is wider that element 702 of FIG. 11A. The distal
end of element 702' is sharpened to facilitate tissue piercing and
may be rotated while disposed within coagulated tissue, e.g., to
slough off or otherwise remove coagulated/ablated tissue.
[0096] Referring now to FIG. 12, a method of utilizing the
apparatus of FIG. 11 to mark tissue is described. As shown, tissue
T may comprise cut C formed by piercing element 702 or 702', as
well as coagulated (or ablated, etc.) region Co formed with
coagulator tip 704. A depth of cut C may be controlled by
specifying a length of element 702/702' that extends beyond
coagulator tip 704. The cut and/or the coagulated region may
provide a physical marking that may be visualized for mapping out a
surgical procedure. Coagulation Co is expected to reduce bleeding
induced by formation of cut C and may also facilitate engagement of
the coagulated tissue, as described hereinafter.
[0097] In addition to providing a physical marking, when tissue T
comprises stomach tissue, cut C may locally remove mucosa and cause
bleeding. If cut C is held in apposition with other tissue, the
local bleeding or mucosectomy may initiate a wound healing response
that gradually fuses the cut to the apposed tissue. Applicant has
previously described initiation of a wound healing response to fuse
tissue, for example, in co-pending U.S. patent application Ser. No.
10/898,683, filed Jul. 23, 2004, which is incorporated herein by
reference in its entirety. Furthermore, local removal of the mucosa
along cut C or coagulation region Co may expose underlying
muscularis, which then may be engaged directly.
[0098] With reference to FIG. 13, additional variations of tissue
marking apparatus configured to pierce and coagulate, as well as
irrigate, tissue are described. In FIG. 13A, apparatus 710
comprises double blade piercing element 712, which optionally may
be energizable, that extends from energizable coagulation tip 714
having irrigation ports 715. FIG. 13B illustrates a variation of
apparatus 710 having single blade piercing element 712'.
[0099] Tip 714 is coupled to torqueable shaft 716 having irrigation
lumen 717 that is connected to ports 715. Fluid irrigants may be
injected through lumen 717 of shaft 716 and ports 715 of tip 714.
Shaft 716 also conveys electromagnetic impulses between energy
source 720 (which may, for example, comprise RF generator 40) and
tip 714 or piercing element 712/712'. In use, element 712/712' may
pierce tissue, tip 714 may coagulate tissue, and irrigation ports
715 may convey irrigants for cooling pierced and/or coagulated
tissue. Furthermore, shaft 716 may be torqued while piercing
element 712/712' is disposed within tissue; in this manner, tissue
singed, burned, coagulated, etc., with tip 714 may be removed.
[0100] With reference to FIG. 14, multi-point tissue marking
apparatus configured to ablate and/or weld tissue is described. As
seen in FIG. 14A, apparatus 730 comprises shaft 732 coupled to
energy source 720 and having tip 734 with multiple elongate
elements 736. As seen in the detail view of FIG. 14B, each element
736 comprises energizable core 737 surrounded by insulated sleeve
738. Sleeve 738 extends near the distal end of each element 736,
such that core 737 is only exposed for ablating or welding tissue,
etc., at the distal tip of the element.
[0101] Referring to FIG. 15, a method of using apparatus 730 to
mark and weld tissue is described. Mucosal tissue layer Muc and
muscularis tissue layer Mus of stomach tissue T have been welded
together within weld zone W. Such welding may be achieved, for
example, with an elongate element 736. The exposed distal core of
such an element may be placed in contact with tissue in the weld
zone and energized to weld the mucosal tissue to the muscularis
tissue. As apparatus 730 comprises multiple elements 736, this
procedure may be repeated at several points simultaneously.
[0102] Malleable submucosal connective tissue, which weakly joins
muscularis tissue to mucosal tissue; as well as the composition of
mucosal tissue itself, may make it challenging to securely engage
muscularis tissue from the interior of a patient's stomach. Thus,
in addition to providing tissue marks that may be used to map out a
surgical procedure, use of apparatus 730 may facilitate engagement
of tissue within the weld zone(s). Such engagement may be achieved
due to more secure binding of the mucosal layer to the muscularis
layer, as well as denaturing or denuding of the mucosal layer.
[0103] With reference now to FIG. 16, a method of marking tissue
with apparatus configured for plug mucosectomy and electrocautery
is described. Apparatus 800 comprises shaft 802 having lumen 803
and sharpened distal tip 804. Shaft 802 illustratively comprises
knob 806 for rotating the shaft; however, shaft 802 alternatively
or additionally may be rotated via a motor (not shown). The shaft
is proximally disposed within hollow handle 808 through distal port
809a. Handle 808 further comprises proximal port 809b, which is
coupled to suction pump 20 via tubing 22, and O-ring 810, which may
facilitate rotation of shaft 802 and which provides a seal for
drawing suction through lumen 803 of the shaft.
[0104] Handle 808 also comprises floating electrical connection 812
coupled to electrical jack 814, which is connected to energy source
720, e.g., RF generator 40. Connection 812 contacts shaft 802 and
facilitates energizing of the shaft during concurrent rotation
thereof, e.g., via knob 806. Shaft 802 comprises insulation sleeve
816 that covers the shaft between the point of contact with
electrical connection 812 and-the sharpened distal tip 804. In this
manner, distal tip 802 may be energized selectively via energy
source 720.
[0105] As seen in FIG. 16, sharpened distal tip 804 may be advanced
against tissue T, and suction may be drawn through lumen 803 of
shaft 802, such that the sharpened distal tip pierces the tissue
and is advanced therein. Shaft 802 may be rotated via knob 806, and
tip 804 may be energized, such that plug mucosectomy PM is formed
and cauterized within tissue T. Plug mucosectomy PM marks the
tissue and may be used to map out a surgical procedure.
Furthermore, removal of the mucosa Muc may facilitate grasping or
other engagement of the underlying muscularis Mus, and also may
facilitate optional initiation of a wound healing response through
apposition of plug mucosectomy PM with other tissue.
[0106] Referring to FIG. 17, a variation of apparatus 800 is
described comprising optional irrigation. In FIG. 17, handle 808'
comprises ports 809b(1) and 809b(2). Port 809b(1) may, for example,
be coupled to suction pump 20 via tubing 22, as described
previously, while port 809b(2) may be coupled to an irrigation
source for injecting fluids through lumen 803 of shaft 802. In this
manner, apparatus 800 may provide for both energizing and delivery
of fluids at the position of plug mucosectomy.
[0107] Referring to FIG. 18, another variation of apparatus 800 is
described comprising cutting wire 818, which optionally may be
energizable. Wire 818 is used in combination with distal tip 804 to
form a plug mucosectomy. The wire severs the mucosal tissue layer
from the muscularis tissue layer during rotation of shaft 802 for
formation of the plug mucosectomy. The wire may also ablate or
coagulate tissue while energized. Wire 818 optionally may be
energized alone or concurrently with tip 804 (e.g., as part of a
bipolar electrode pair), and optionally may be energized while
suction is drawn and/or irrigants are injected through lumen 803 of
shaft 802.
[0108] With reference now to FIG. 19, further variations of
apparatus 800 are described comprising depth-limiting elements. The
depth-limiting elements optionally may be energized and utilized in
combination with tip 804 to form a bipolar electrode pair. In FIG.
19A, apparatus 800 comprises expandable mesh 830. Mesh 830 is
distally coupled to shaft 802 and is proximally coupled to tube
840. Tube 840 is coaxially disposed about shaft 802 and may be
advanced relative to the shaft to expand the mesh, as shown. In the
expanded configuration, mesh 830 may contact tissue to limit a
depth of tissue cutting. Mesh 830 also may be collapsed to a lower
profile delivery and retrieval configuration by retracting tube 840
relative to shaft 802.
[0109] In FIG. 19B, apparatus 800 comprises expandable bellows 832
that is distally coupled to shaft 802 and proximally coupled to
tube 840. As with mesh 830, bellows 832 may be expanded and
collapsed via movement of tube 840 relative to shaft 802. FIG. 19C
illustrates another variation of apparatus 800 comprising
inflatable balloon 834 disposed near distal tip 804 of shaft 802.
Balloon 834 may be inflated to contact tissue and limit a depth of
tissue cutting. As with the previous variations, suction and/or
irrigation may be provided in combination with FIG. 19.
[0110] Referring to FIG. 20, a method of using apparatus 800 to map
out endoluminal GI surgery, as well as to directly engage
muscularis tissue and to actually perform endoluminal gastric
reduction or partition, is described. Apparatus 800 may be
advanced, e.g., endoluminally, laparoscopically, etc., into stomach
S, and a plurality of plug mucosectomies PM may be formed along
opposing anterior An and posterior Po rows within the stomach, as
in FIG. 20A. The opposing rows provide a medical practitioner with
a map for performing an endoluminal gastric restriction procedure.
For example, an anterior plug mucosectomy may be engaged for
forming a tissue fold, and a co-planar posterior plug mucosectomy
may be engaged to form an opposing tissue fold that may be
approximated with the anterior tissue fold to form a localized
partition of the stomach. This procedure may be repeated,
concurrently or sequentially, until anterior and posterior tissue
folds have been brought into apposition along the opposing rows of
plug mucosectomies, thereby partitioning the patient's stomach,
e.g., forming a pouch therein, as described hereinbelow. The map
provided by plug mucosectomies PM may guide formation of the tissue
folds to ensure proper placement, spacing, etc., of the folds
[0111] Advantageously, plug mucosectomies PM may facilitate direct
internal engagement of gastric muscularis tissue. In FIG. 20B,
corkscrew engagement element 900 illustratively has been advanced
through tissue folding and securing apparatus 910, and into a plug
mucosectomy for direct internal engagement of the muscularis. It is
expected that direct engagement of muscularis (e.g., engagement of
muscularis without encountering intervening mucosa, or engagement
through welded or ablated mucosa) will reduce a length, size and/or
required working space of apparatus for internally engaging,
folding and securing gastric tissue. Exemplary variations of such
engaging, folding and securing apparatus, including methods of use,
are described in Applicant's co-pending U.S. patent application
Ser. No. 10/955,245, filed Sep. 29, 2004, which is incorporated
herein by reference in its entirety.
[0112] FIGS. 20C-20F are detail views of element 900 and apparatus
910 illustrating direct muscularis engagement, as well as formation
and approximation of opposing tissue folds. As seen in FIG. 20C,
corkscrew engagement element 900 has been advanced within posterior
Po plug mucosectomy PM, and has directly engaged muscularis tissue
Mus. In FIG. 20D, element 900 is retracted relative to tissue
folding apparatus 910, thereby drawing stomach tissue T between
first bail 912 and second bail 914 of apparatus 910, and forming
posterior tissue fold F.sub.p. As seen in FIG. 20E, launch tube 916
of apparatus 910 may be reconfigured from a low profile delivery
configuration to a deployment configuration substantially
perpendicular to tissue fold F.sub.p. Needle 918 they may be
advanced through tube 916 and across the tissue fold. As seen in
FIG. 20F, securing element 920 may be deployed through needle 918
for temporarily or permanently maintaining the tissue fold. This
procedure may be repeated to form opposing anterior tissue fold
F.sub.a, and the anterior and posterior tissue folds may be
approximated to locally partition a patient's stomach.
[0113] Concurrently or sequentially (or both), opposing rows of
anterior R.sub.a and posterior R.sub.p tissue folds may be formed
along the opposing anterior and posterior rows of plug
mucosectomies PM of FIG. 20A, as seen in FIG. 20G. As seen in FIG.
20H, the opposing rows may be approximated, either during formation
of individual opposing folds or after formation of opposing rows of
folds (or both), to form pouch or partition P within stomach S. The
rows of opposing tissue folds may be approximated and secured
together in a variety of ways, e.g., via securing elements or
suture. Alternatively, the rows may be clamped (temporarily or
otherwise) or held against one another for welding the tissue
together. Various tissue clamping devices have been described
previously which have been utilized for various purposes, for
example, U.S. SIR No. H2037 to Yates et al. and U.S. Pat. No.
5,300,065 to Anderson, both of which are incorporated herein by
reference in their entireties, describe in further detail clamping
tools that may be used for welding or sealing tissue.
[0114] As seen in FIG. 20H, illustrative bipolar clamping and
welding tool 930 may be utilized to approximate and/or secure the
rows of opposing folds together. Tool 930 comprises first electrode
933 disposed on first clamp 932 and second electrode 935 disposed
on second clamp 934. Tool 930 may, for example, be positioned such
that the anterior R.sub.a and posterior R.sub.p rows of tissue
folds are clamped between first clamp 932 and second clamp 934.
Radiofrequency or other energy then may be delivered across first
electrode 933 and second electrode 935 to weld the anterior and
posterior rows of tissue folds together. Optionally, solder So may
be provided along the region of overlap or contact between the
approximated rows of tissue folds in order to facilitate tissue
welding. A variety of tissue solders, per se known, may be
utilized, e.g., albumin.
[0115] Referring now to FIG. 21, apparatus 800 may be used in
combination with monopolar, bipolar or multipolar hemostasis
catheter 950 advanced through lumen 803 of shaft 802. When utilized
in combination with catheter 950, plug mucosectomy optionally may
be performed `hot` or `cold` (i.e. with or without energizing
distal tip 804), and distal tip 804, as well as shaft 802, of
apparatus 800 optionally may be electrically insulated. Catheter
950 may be advanced within a plug mucosectomy site and energized to
cauterize the site. Optional irrigants I may be injected through
the catheter to cool the site during or after electrocautery.
[0116] With reference to FIG. 22, interchangeable marking apparatus
is described. Apparatus 1000 comprises shaft 1002 having female
screw 1004 for attaching and removing interchangeable/exchangeable
heads to shaft 1002 for performing various medical procedures. In
FIG. 22A, apparatus 1000 further comprises illustrative head 1010
having mating male screw 1012 for mating with female screw 1004 of
shaft 1002. As will be apparent, head 1010 alternatively may
comprise the female screw and shaft 1002 may comprise the male
screw. Furthermore, any alternative mating elements may be
provided. Head 1010 illustratively comprises the distal region of
apparatus 730 of FIG. 14A. As with apparatus 730, the elongate
elements of head 1010 may be energized to ablate tissue.
[0117] In FIG. 22B, alternative head 1020 is described comprising
mating screw 1022 and the distal region of apparatus 700 of FIG.
11B. FIG. 22C illustrates head 1030 with mating screw 1032 and the
cutting element distal region of apparatus 710 of FIG. 13A. In FIG.
22D, head 1040 with mating screw 1042 comprises the distal region
of plug mucosectomy apparatus 800 of FIG. 16. Additional
exchangeable heads will be apparent.
[0118] Referring now to FIG. 23, methods of using additional
variations of mucosectomy apparatus to remove mucosal tissue are
described. In FIG. 23A, apparatus 1100 comprises tube 1110 having
lumen 1111 through which grasper 1120, illustratively corkscrew
engagement element 900 that may be screwed into tissue to
reversibly engage the tissue, has been advanced. Apparatus 1100
further comprises wire 1130 coupled to the distal end of tube 1110
and configured to pivot thereabout, e.g., via controllable
actuation by a medical practitioner external to the patient (see,
e.g., FIG. 24).
[0119] As shown, grasper 1120 engages and separates mucosal tissue
Muc from muscularis tissue Mus. A plug of the engaged mucosal
tissue is retracted proximal of wire 1130, which is then pivoted
about tube 1110 to sever and separate the plug of tissue from the
mucosa, thereby exposing the underlying muscularis, e.g., for the
purposes of physical marking, ease of tissue engagement and/or
wound healing. Severed tissue optionally may be aspirated or
otherwise removed from the patient.
[0120] Wire 1130 may comprise a sharpened blade to sever the
tissue. Alternatively or additionally, wire 1130 may be
electrically coupled to energy source 720 and may be energized to
cut through the tissue. To act as a safety mechanism, energizing
and pivoting of wire 1130 may be linked, such that wire 1130 is
only energized when a medical practitioner pivots the wire.
[0121] FIG. 23B provides a variation of apparatus 1100 that
illustrates an exemplary technique for removing severed tissue from
the patient. In FIG. 23B, "Archimedes" screw pump 1140 is disposed
within lumen 1111 of tube 1110. Rotation of screw pump 1140
proximally conveys material disposed within the screw. Thus,
severed tissue may be retracted within tube 1110, e.g., via suction
or via grasper 1120 (which illustratively is coaxially disposed
within a central lumen of the screw pump). Screw pump 1140 then may
be rotated to remove the severed material and/or proximally retract
the material far enough within lumen 1111 to make room for
additional plugs of severed mucosa removed at additional desired
locations. Screw pump 1140 optionally may be integrated with
corkscrew engagement element 900. Flexible medical devices
incorporating screw pumps have previously been described in U.S.
Pat. No. 6,156,046 to Passafaro et al., which is incorporated
herein by reference in its entirety.
[0122] Referring now to FIG. 24, a suction engagement variation of
apparatus 1100 is described that does not comprise grasper 1120 or
screw pump 1140. Rather, suction may be drawn through lumen 1111 of
tube 1110 to engage mucosal tissue, as well as to aspirate tissue
severed via wire 1130. A diameter of lumen 1111 may be specified to
facilitate engagement of mucosal tissue, but not muscularis
tissue.
[0123] FIG. 24 also illustrate an exemplary technique for pivoting
wire 1130 about tube 1110. As shown, wire 1130 may be distally
disposed within rotational bearing 1112 of tube 1110, and may be
proximally coupled to elongated member 1132. Elongated member 1132
extends proximally out of the patient from wire 1130 through lumen
1111 of tube 1110. A medical practitioner may advance member 1132
relative to tube 1110 in order to pivot wire 1130 about bearing
1112 and tube 1110. With member 1132 proximally retracted, wire
1130 may be disposed in the delivery configuration of FIG. 24A,
while with member 1132 distally extended, wire 1130 may pivot to
the deployed tissue-cutting configuration of FIG. 24B.
[0124] When wire 1130 is energizable, electrical or other energy
impulses may be transmitted from energy source 720 to wire 1130
through elongated member 1132. Member 1132 optionally may be
insulated to protect the medical practitioner from, e.g.,
electrical discharge. Furthermore, distal advancement of member
1132 optionally may activate energy source 720 while proximal
retraction of the member may deactivate the energy source.
[0125] Referring to FIG. 25, another suction variation of apparatus
1100 is described. In FIG. 25, tube 1110 has been modified, such
that lumen 1111 terminates at side aperture 1114 instead of a
distal opening. Furthermore, wire 1130 has been formed into a
cutting loop that may be advanced and retracted within lumen 1111
via elongated member(s) 1132.
[0126] As seen in FIG. 25A, wire 1130 may be advanced distally of
side aperture 1114, which may be positioned in proximity to mucosal
tissue Muc. Suction then may be drawn through lumen 1111 of tube
1110 to separate a plug of the mucosal tissue from muscularis Mus,
with only submucosal tissue Sub disposed therebetween. As seen in
FIG. 25B, retracting wire cutting loop 1130 relative to tube 1110
severs the plug of mucosal tissue disposed within lumen 1111. As
discussed previously, wire 1130 may be sharpened and/or energized
to sever the tissue plug. The severed tissue is then aspirated via
suction drawn through lumen 1111. This procedure may be repeated at
additional locations, e.g., to map out a GI procedure, to
facilitate direct engagement of the muscularis, to initiate a wound
healing response, etc.
[0127] With reference to FIG. 26, yet another suction variation of
apparatus 1100 is described. In FIG. 26, lumen 1111 again
terminates at a distal opening of tube 1110. Wire 1130 has been
formed into an arc coupled to elongated member 1132. Member 1132 is
configured for rotation and torque transmission. As seen in FIG.
26A, suction may be drawn through tube 1110 to draw a plug of
muscularis Mus within lumen 1111. Wire 1130 contacts the plug of
tissue and may be rotated via member 1132 to sever the plug, as
seen in FIG. 26B. Member 1132 optionally may be coupled to a motor
(not shown) to facilitate rotation. Alternatively, a medical
practitioner may manually rotate the member. Wire 1130 may be
sharpened and/or energized in order to sever the tissue plug, which
then is aspirated via suction drawn through lumen 1111.
[0128] Referring now to FIG. 27, additional mucosectomy apparatus
is described. Apparatus 1200 comprises biopsy probe 1210, which has
been advanced through lumen 1221 of tube 1220. Probe 1210 comprises
aspiration holes 1212. In use, probe 1210 may be advanced against
muscularis tissue, and the jaws of the probe may be closed to sever
a plug of the tissue. Suction then may be drawn through lumen 1221
of tube 1220, with holes 1212 providing for airflow through probe
1210. This facilitates aspiration of severed mucosal tissue
disposed within the probe. Probe 1210 optionally may be
energizable, e.g., via coupling to energy source 720. If energized,
probe 1210 preferably is only energized along edge 1215 of jaws
1214, thereby enhancing energy density for a given magnitude of
energy input.
[0129] With reference to FIG. 28, measuring apparatus are described
for determining appropriate spacing of tissue markings, e.g.,
anterior and posterior tissue markings for mapping out endoluminal
gastric reduction or partitioning. In FIGS. 28A and 28B, a
variation of measuring apparatus 1300 illustratively comprises
elongated shaft 1302, anterior ruler 1304 and posterior ruler 1306.
The rulers and shaft optionally may be flexible to facilitate
endoluminal delivery. Rulers 1304 and 1306 comprise measurement
indicia In for measuring distances along the rulers. The rulers are
coupled to shaft 1302 of apparatus 1300 at radial bearing 1303 and
are configured to rotate about the bearing from the collapsed
delivery configuration of FIG. 28A to the expanded deployed
configuration of FIG. 28B.
[0130] Rulers 1304 and 1306 may also comprise energizable
electrodes 1308a and 1308b, which may be energized via energy
source 720 in order to mark tissue. A distance D between electrodes
1308a and 1308b in the expanded deployed configuration of FIG. 28B
may be specified to provide a desired spacing of tissue markings
formed therewith. For example, the electrodes may be spaced such
that the spacing between opposing anterior and posterior tissue
markings is as desired. As will be apparent, a single electrode or
more than two electrodes alternatively may be provided.
Furthermore, alternative marking elements may be provided, e.g.,
ink injection elements, etc.
[0131] FIG. 28C provides another variation of apparatus 1300,
illustratively disposed in deployed configuration. In the variation
of FIG. 28C, apparatus 1300 comprises unitary ruler 1304'
rotationally coupled to shaft 1302 at bearing 1303. As with rulers
1304 and 1306, ruler 1304' comprises measurement indicia In and
optional electrode or other marking element 1308, illustratively
coupled to energy source 720. Ruler 1304' may be cantilevered from
a reduced profile delivery and/or retrieval position in line with a
longitudinal axis of shaft 1302, to a position out of line with the
shaft's longitudinal axis (as in FIG. 28C) for taking measurements
and/or marking tissue. Shaft 1302 of apparatus 1300 may be rotated
about its longitudinal axis to measure distances with ruler 1304'
in any direction perpendicular to the shaft.
[0132] Referring now to FIG. 29, a laparoscopic endoluminal method
of using another variation of apparatus 1300 to map out endoluminal
GI surgery is described. In FIG. 29, bougie 750 has been advanced
endoluminally down a patient's throat into the patient's stomach S,
and has been positioned along the lesser curvature of the patient's
stomach. A variation of apparatus 1300 has been laparoscopically
advanced into the patient's stomach in a collapsed delivery
configuration, then expanded to the deployed configuration and
brought into contact with bougie 750, as seen in FIG. 29A.
[0133] As best seen in FIG. 29B, apparatus 1300 may comprise
central member 1305 that stabilizes apparatus 1300 against bougie
750 (bougie 750 alternatively may comprise a groove or other
surface feature in which apparatus 1300 may be mated, stabilized,
etc.). Rulers 1304 and 1306 extend from shaft 1302 towards the
anterior An and posterior Po regions of stomach S, respectively. As
shown, the rulers may comprise a curvature and/or may be formed
from a self-conforming material, such as Nitinol. In this manner,
the rulers may approximately follow the curvature of stomach S,
thereby providing for more accurate measurements of distance with
indicia In.
[0134] With rulers 1304 and 1306 properly positioned, optional
electrodes 1308 may be energized to physically mark the tissue with
markings M. Alternatively, secondary marking apparatus may be
utilized to mark the tissue at desired locations, determined, for
example, via indicia In. Apparatus 1300 then may be repositioned
along the length of bougie 750 in additional planes, where
additional anterior and posterior tissue markings may be formed
until a desired pattern of markings has been achieved, e.g.,
opposing anterior and posterior rows of markings. The apparatus
then may be collapsed back to the delivery configuration and
removed from the patient. Bougie 750 optionally may also be
removed.
[0135] With reference to FIG. 30, a fully endoluminal method of
using apparatus 1300 to map out endoluminal GI surgery is
described. In FIG. 30A, steerable endoluminal support 1400 is
advanced per-orally into the patient's stomach, and is then
retroflexed such that a distal opening of lumen(s) 1401 that
extends through the support is positioned facing body 1402 of the
support. Steerable endoluminal supports capable of retroflexing are
described in more detail in Applicant's co-pending U.S. patent
application Ser. No. 10/797,485, filed Mar. 9, 2004, which is
incorporated herein by reference in its entirety (not shown).
[0136] Apparatus 1300 is then advanced through lumen 1401, is
expanded to the deployed configuration, and is positioned in
contact with body 1402 of support 1400, as in FIG. 30B. In another
variation, apparatus 1300 may be attached to a distal region of
support 1400. Rulers 1304 and 1306 contact the patient's stomach S
along anterior and posterior segments, respectively. Tissue
markings may be made, e.g., with electrodes 1308. Then, a degree of
retroflexion of endoluminal support 1400 may be altered to
reposition apparatus 1300 in a different plane within the patient's
stomach wherein additional tissue markings may be made. The
procedure may be repeated until a desired pattern of tissue
markings have been made for mapping out GI surgery. Apparatus 1300
then may be collapsed back to the delivery configuration within
lumen 1401 and may be removed from the patient.
[0137] Referring now to FIG. 31, combination measurement and
mucosectomy apparatus is described. Apparatus 1500 comprises
central shaft 1501 with optional central member 1502 having end
region 1503 for stabilizing the apparatus against, e.g., bougie
750. Apparatus 1500 further comprises collapsible anterior and
posterior shafts 1504 and 1506, respectively, that extend from
shaft 1501. Shafts 1504 and 1506 illustratively comprise optional
indicia In for measuring distances within a body lumen, as well as
plug mucosectomy tips 1505 and 1507, respectively. Tips 1505 and
1507 are similar to previously described sharpened distal tip 804
of apparatus 800 and are configured to form plug mucosectomies
within a patient's stomach. The tips optionally may be energized to
ablate, cut or cauterize tissue. FIG. 31A illustrates a collapsed
delivery and/or retrieval configuration of apparatus 1500, while
FIG. 31B illustrates an expanded deployed configuration.
[0138] In use, tips 1505 and 1507 may, for example, be utilized to
simultaneously or sequentially form anterior and posterior plug
mucosectomies within a patient's stomach. In addition or as an
alternative to tips 1505 and 1507, shafts 1504 and 1506 may
comprise any previously described or other engagement, marking,
ablation, mucosectomy, etc., tips for mapping out or otherwise
facilitating endoluminal GI surgery, e.g., for facilitating direct
muscularis engagement and/or for initiating a wound healing
response. Furthermore, the shafts may comprise tips that perform
different functions. For example, one shaft may comprise a grasper
for engaging and stabilizing apparatus 1500 against tissue, while
the opposing shaft may comprise apparatus for marking tissue or
performing mucosectomy. Additional variations will be apparent.
[0139] With reference to FIG. 32, in combination with FIG. 33,
centerline marking apparatus 1600 is described. Apparatus 1600
comprises endoluminal support 1602, which may, for example,
comprise a bougie or a steerable and/or shape-lockable shaft.
Support 1602 comprises a plurality of electrodes 1604 disposed at
specified positions with desired spacing along the support.
Electrodes 1602 are electrically coupled to energy source 720 to
facilitate selective energizing of the electrodes to mark tissue in
contact therewith. Support 1602 further optionally may comprise
inflatable member 1610 for reversibly engaging a patient's pylorus,
as well as measurement indicia In and lumen 1603 with port or slot
1620 in communication with the lumen.
[0140] As seen in FIG. 33A, endoluminal support 1602 of apparatus
1600 may be positioned within a patient's stomach S, e.g., along a
lesser curvature of the stomach. In one variation, support 1602 may
be shape-locked to maintain its position along the lesser
curvature. Additionally or alternatively, optional inflatable
member 1610 may be positioned within the patient's pylorus P and
inflated to reversibly engage the pylorus. Electrodes 1602 then may
be energized to form centerline markings C, as seen in FIG. 33B.
The centerline markings may provide a reference from which anterior
and posterior distances may be measured or determined, and may
facilitate partitioning of a patient's stomach, e.g., via formation
of anterior and posterior tissue markings and/or tissue folds.
[0141] Referring again to FIG. 33A, endoscope E or other
instruments optionally may be advanced through lumen 1603 and slot
1620 while endoluminal support 1602 is disposed within the
patient's stomach. Endoscope E may, for example, provide visual
confirmation that support 1602 is properly positioned for formation
of centerline markings C. Methods and apparatus for performing
gastroplasty with slotted endoluminal supports are described in
greater detail in Applicant's co-pending U.S. patent application
Ser. No. 10/841,415, filed May 7, 2004, which is incorporated
herein by reference in its entirety.
[0142] With reference to FIG. 34, a method of using the apparatus
of FIG. 31 in combination with the centerline markings of FIG. 33
to map out endoluminal GI surgery is described. As seen in FIG.
34A, a variation of apparatus 1500 is provided comprising central
member 1502 with an optional engagement element end region 1503',
illustratively a corkscrew grasping element, for engaging a
centerline marking C. The positioning of central member 1503 in
contact with the centerline orients apparatus 1500 within the
patient's stomach. As seen in FIG. 34B, anterior An and posterior
Po plug mucosectomies PM may be formed with tips 1505 and 1507 of
shafts 1504 and 1506. Apparatus 1500 then may be repositioned along
the centerline as shown, e.g., into contact with additional
centerline markings C to form additional plug mucosectomies. The
spacing of such markings may be specified to facilitate mapping out
of endoluminal GI surgeries.
[0143] Referring now to FIG. 35, a method of mapping out
endoluminal GI surgery and facilitating direct muscularis
engagement through plug mucosectomy, while initiating a wound
healing response post-surgery through strip mucosectomy, is
described. Centerline markings C may be formed within stomach S,
and then opposing rows of anterior An and posterior Po markings may
be formed utilizing markings C as a reference, e.g., opposing rows
of plug mucosectomies PM may be formed. The anterior and posterior
mucosectomies may provide a map of locations whereat a medical
practitioner may engage the stomach for forming tissue folds.
Furthermore, plug mucosectomies PM advantageously facilitate direct
engagement of muscularis tissue, as described previously.
[0144] In addition to the plug mucosectomies, opposing anterior and
posterior strip mucosectomies SM may be formed between the plug
mucosectomies and the centerline markings. A medical practitioner
may internally engage the patient's stomach at a plug mucosectomy
PM to form a tissue fold, such that the plug mucosectomy is
positioned at the top of the fold (i.e., the turning point or
critical point of the fold, where the slope of the fold changes
direction), and a strip mucosectomy SM forms a side of the fold.
Opposing anterior and posterior folds may be formed in this manner
and approximated to bring the opposing strip mucosectomies SM into
contact. The approximated folds may be secured together in order to
partition stomach S and to initiate a wound healing response along
the apposed strip mucosectomies SM that in time may fuse them
together.
[0145] With reference to FIG. 36, a method of forming a strip
mucosectomy from a series of plug mucosectomies is described. As
seen in FIG. 36A, spaced rows of plug mucosectomies PM may be
formed within a patient's stomach S. Hook knife 1700 comprising
cutting element 1702, which optionally may be energizable, may be
positioned within a plug mucosectomy PM and drawn down to cut away
mucosa Muc disposed between the plug mucosectomies, thereby forming
line mucosectomy LM. As seen in FIG. 36B, opposing line
mucosectomies may be formed along the opposing rows of plug
mucosectomies. Then, strip mucosectomy SM may be formed by removing
mucosal tissue Muc disposed between the opposing line mucosectomies
LM, e.g., by grasping the mucosal tissue and pulling it off,
thereby exposing underlying muscularis Mus.
[0146] Referring to FIG. 37, additional apparatus for forming a
line or strip mucosectomy is described. Apparatus 1800 comprises
shaft 1802 coupled to handle 1804 and having articulating and
energizable distal region 1803. Distal region 1803 may, for
example, be articulated by actuation of lever 1805 disposed along
handle 1804. Distal region 1803 is coupled to energy source 720 for
selectively energizing the region. Region 1803 may be positioned
against GI tissue at a desired location and energized to ablate
and/or remove the mucosa, thereby forming a strip or line
mucosectomy. Articulation of region 1803 may facilitate positioning
of the region in contact with tissue along its length.
[0147] With reference to FIG. 38, additional variations of
apparatus for performing mucosectomy are described. As seen in FIG.
38A, apparatus 1900 illustratively comprises shaft 1910 having
first lumen 1911a and second lumen 1911b. Optional suction tube
1920 has been advanced through lumen 1911a, while optional ligation
snare tube 1930 has been advanced through lumen 1911b. Ligation
snare 1940 has been advanced through tube 1930 against mucosal
tissue Muc. Snare 1940 may, for example, be fabricated from a shape
memory material, e.g., Nitinol, such that the snare may resiliently
assume a pre-formed bend or other shape to lie adjacent to the
mucosal tissue upon exiting tube 1930. Furthermore, the snare may
be energizable.
[0148] Once properly positioned, suction may be drawn through tube
1920 to capture a plug of mucosal tissue within snare 1940. The
snare then may be retracted to cut, sever, ligate. etc., the plug
of mucosal tissue disposed therein, thereby facilitating direct
engagement of muscularis Mus, mapping of gastrointestinal surgery
and/or initiation of a wound healing response. This procedure
optionally may be achieved without utilizing tubes 1920 and 1930.
In such a variation, suction may be drawn directly through lumen
1911a, and ligating snare 1940 may be advanced directly through
lumen 1911b.
[0149] FIG. 38B illustrates a variation of apparatus 1900 wherein
ligation snare tube 1930 is pivotably connected to optional support
1950 that extends from the distal region of shaft 1910. Advancement
of tube 1930 relative to the shaft and the support may provide tube
1930 with a curvature that facilitates proper placement of snare
device 1940' against mucosal tissue Muc. As shown, snare device
1940' does not comprise a pre-formed bend and may be advanced
through tube 1930 while the tube is disposed parallel to the
mucosa.
[0150] Referring now to FIG. 39, another variation of apparatus for
performing tissue marking and/or mucosectomy is described. As seen
in FIG. 39A, apparatus 2000 comprises syringe 2010, needle 2020 and
overtube 2030. Needle 2020 comprises syringe attachment 2022 and
overtube attachment 2024. Overtube 2030 having lumen 2031 may
comprise, for example, a substantially rigid laparoscopy trocar or,
alternatively, a flexible endoluminal overtube. As seen in FIG.
39B, needle 2020 may be coupled to syringe 2010 via syringe
attachment 2022 and may be advanced through lumen 2031 of overtube
2030. Additionally, needle 2020 optionally may be coupled to
overtube 2030 via overtube attachment 2024.
[0151] With reference to FIG. 40, a method of utilizing the
apparatus of FIG. 39 to separate mucosal tissue from underlying
muscularis tissue is described. As seen in FIG. 40A, the sharpened
distal tip of needle 2020 may be advanced into submucosa Sub
between mucosa Muc and muscularis Mus. A distance that needle 2020
extends beyond a distal end of overtube 2030 may act as a
depth-limiting element to ensure that the needle is not
inadvertently advanced into the muscularis. As seen in FIG. 40B, a
fluid, such as air, saline, dye, etc., may be injected through
syringe 2010 and needle 2020 into the submucosal space to form
fluid bolus Bo that separates mucosa Muc from muscularis Mus. Bolus
Bo may provide a visually identifiable tissue marking and/or may
facilitate mucosectomy, e.g., via a snare device.
[0152] Referring now to FIG. 41, needle 2020 may be repositioned to
additional locations in order to separate the muscularis and
mucosal tissue at a plurality of desired locations and/or in any
desired shape or configuration. In FIG. 41, illustrative strip
bolus SB is formed by forming a plurality of boluses along a line.
This may facilitate optional formation of a strip or line
mucosectomy.
[0153] With reference to FIG. 42, integrated apparatus for both
separating mucosal tissue from underlying muscularis tissue, and
for resecting the separated mucosal tissue, is described. Apparatus
2100 comprises elongated shaft 2110, which may be rigid or flexible
and configured for laparoscopic or endoluminal advancement. Distal
needle 2120 extends from shaft 2110 and is configured to separate
mucosal tissue from muscularis via injection of a bolus of fluid,
as described previously with respect to needle 2020 of FIGS. 39-41.
Lumen 2111 extends through shaft 2110 and is in fluid communication
with needle 2120 for delivery of the fluid bolus. The distal end of
needle 2120 may project from shaft 2110 at a sufficient distance
such that needle 2120 may be inserted unhindered through or into
the mucosa Muc.
[0154] Shaft 2110 further comprises channel 2130 which may define a
curved channel and may extend proximally to provide sufficient
spacing for parting the resected mucosa Muc. Dimension D across the
channel limits a depth of mutcosal resection, thereby reducing a
risk of resecting underlying muscularis or serosal tissue.
Energizable element 2140, which may comprise a wire or conductive
segment, may extend across channel 2130 for resecting mucosa.
Element 2140 is proximally connected, e.g., via wire(s) 2142, to an
energy source, such as previously described energy source 720,
which may, for example, comprise previously described RF generator
40, although any alternative energy source may be provided.
Although element 2140 is illustrated as a wire, element 2140 may
alternatively be a blade having a cutting edge for slicing through
the mucosa.
[0155] Referring now to FIG. 43, a method of using apparatus 2100
to separate and resect mucosal tissue is described. As seen in FIG.
43A, needle 2120 pierces mucosal tissue Muc and is disposed within
submucosa Sub or within the mucosal tissue itself. Fluid bolus Bo
is injected through the needle into the submucosal space to
separate the mucosa from muscularis Mus. The amount of fluid
injected may be dispensed at a steady rate or it may be injected
intermittently to provide for measured dispensation of the fluid.
In FIG. 43B, as apparatus 2100 is advanced distally, channel 2130
limits a depth of insertion of needle 2120, and energizable element
2140 abuts the separated mucosa. The energizable element is
energized to resect the mucosa along channel 2130. As seen in FIG.
43C, needle 2120 may continue to inject fluid bolus Bo as apparatus
2100 is advanced, thereby forming a line or strip of separated
mucosa Muc that is resected away with energizable element 2140.
[0156] With reference to FIG. 44, a variation of the integrated
mucosal separation and resection apparatus of FIG. 42 is described.
Shaft 2110' of apparatus 2100' comprises hook 2112 that directs
needle 2120 toward the proximal end of apparatus 2100' and forms
channel 2130'. Energizable element 2140, which is coupled to an
energy source, extends across channel 2130' for resecting mucosal
tissue. Element 2140 additionally or alternatively may comprise a
mechanical cutting blade. Dimension D' across channel 2130' limits
a depth of mucosal resection and reduces a risk of muscularis or
serosal tissue resection.
[0157] FIG. 45 illustrates a method of using the apparatus of FIG.
44. Apparatus 2100' may be used in a manner similar to apparatus
2100, except that resection is achieved while proximally retracting
apparatus 2100', as opposed to distally advancing tie apparatus. As
shown, needle 2120 is retracted into submucosa Sub, and fluid bolus
Bo is injected through the needle to separate mucosa Muc from
muscularis Mus. As apparatus 2100' is retracted, needle 2120
optionally may continue to inject fluid into the submucosal space.
Element 2140 is energized, and the element resects the separated
mucosa along a line or strip. Channel 2130' limits the depth of
mucosal resection.
[0158] With reference to FIG. 46, additional variations of the
apparatus of FIG. 42 are described. It is expected that apparatus
2100'' may be especially well suited for laparoscopic and/or
endoluminal use, though it should be understood that it
alternatively or additionally may be used in a pure endoluminal
fashion or in any other manner. As seen in FIG. 46, needle 2120 is
disposed at an angle with respect to shaft 2110''. The angle
between needle 2120 and shaft 2110'' may be varied as desired or
necessary. In the variation of FIG. 46A, energizable element 2140
extends across channel 2130'' parallel to the longitudinal axis of
shaft 2110''. In the variation of FIG. 46B, the energizable element
extends across the channel at an angle, illustratively
perpendicular, to the longitudinal axis of the shaft. The
variations of FIG. 46 may be used in a manner similar to that
described previously with respect to apparatus 2100 or 2100'. For
example, needle 2120 may be inserted into the submucosal space to
inject a bolus of fluid that separates the mucosa from the
muscularis. Energizable element 2140 then may be used to resect the
separated mucosa.
[0159] Referring now to FIG. 47, yet another variation of
integrated mucosal separation and resection apparatus is described.
Apparatus 2200 comprises shaft 2210 having inclined surface or
wedge 2220 with sharpened distal tip 2222. Wedge 2220, which
optionally may comprise a needle configured to inject fluids,
illustratively is disposed perpendicular to the longitudinal axis
of shaft 2210; however, it should be understood that the wedge
alternatively may be positioned at any other desired angle or
orientation relative to the shaft and/or to blade 2230. If a needle
is utilized with wedge 2220, one or more openings of the needle for
fluid dispensation may be located at the distal tip 2222 (as a
hollow puncture needle) or along the sides of the length of wedge
2220. Blade 2230 having sharpened edge 2232 is positioned in
proximity to the wedge and forms channel 2240. As illustrated by
arrows in FIG. 47, the position of blade 2230 relative to wedge
2220 optionally may be altered to adjust the size of channel 2240.
Edge 2232 of blade 2230 optionally may be energizable.
[0160] With reference to FIG. 48. a method of using apparatus 2200
to perform mucosectomy is described. Sharpened distal tip 2222
pierces mucosa Muc and is positioned in the submucosal space Sub.
As shaft 2210 is moved laterally, the mucosa moves up the inclined
surface of wedge 2220 and is separated from muscularis Mus. If
wedge 2220 comprises a needle, a bolus of fluid optionally may be
injected into the submucosa to facilitate separation of the mucosa
from the muscularis.
[0161] Upon reaching a desired separation from the muscularis, the
mucosa contacts blade 2230 and is resected by sharpened edge 2232
of the blade. Edge 2232 optionally may be energized to facilitate
such resection. Continued lateral movement of shaft 2210 resects
mucosa Muc along a line or strip.
[0162] Referring now to FIG. 49, integrated mucosal separation and
resection apparatus comprising a dissector is described. Apparatus
2300 comprises elongated shaft 2310 having end dissector 2320.
Dissector 2320 comprises sharpened distal tip 2322 having needle
2324, e.g., for injecting fluid submucosally. Dissector 2320
further comprises actuable jaws 2326 for resecting mucosa. Jaws
2326 may be energizable and coupled to an energy source.
[0163] With reference to FIG. 50, a method of using apparatus 2300
is described. As seen in FIG. 50A, needle 2324 is advanced into
submucosal space Sub, and fluid bolus Bo is injected through the
needle into the space to separate mucosa Muc from muscularis Mus.
The arrow in FIG. 50A illustrates that apparatus 2300 optionally
may be rotated relative to the tissue, as desired. In FIG. 50B,
apparatus 2300 illustratively has been rotated about 90.degree.
relative to the tissue to properly align jaws 2326 for engaging the
tissue.
[0164] As seen in FIG. 50B, apparatus 2300 is withdrawn to remove
needle 2324 and the distal portion of jaws 2326 from the submucosal
space. Jaws 2326 then are opened for engaging and resecting the
separated mucosa. The jaws preferably are energized as they engage
mucosa Muc, which dissects or resects the mucosa as the jaws are
closed about the tissue. Alternatively or additionally, the jaws
may be sharpened to resect the tissue. This process of separating
the mucosa from the muscularis, followed by resection of the
mucosa, may be repeated as desired.
[0165] Referring now to FIG. 51, another variation of integrated
mucosal separation and resection apparatus is described. Apparatus
2400 comprises inclined member 2410, which may, for example,
comprise a wedge, an inclined plane or a `shoe horn`-type device.
Member 2410 comprises raised resection element 2420, which may, for
example, comprise a blade or other cutting element or an
energizable element, such as an RF wire. When element 2420
comprises an energizable element, member 2410 optionally may be
fabricated from a material of low electric conductivity, such as a
ceramic.
[0166] FIG. 52 illustrates a method of using apparatus 2400. An
incision or puncture is formed through mucosa Muc, and member 2410
is advanced through the incision/puncture into submucosal space
Sub. Apparatus 2400 optionally may form the initial incision
through mucosa Muc through which member 2410 enters submucosal
space Sub. For example, the distal end of member 2410 may comprise
a sharpened element for piercing the mucosa. Alternatively, the
distal end of the member may be energizable to ablate a hole
through the mucosa. Additional techniques for entering the
submucosal space will be apparent.
[0167] Once disposed within the submucosal space, continued
advancement of member 2410 urges the mucosa up the member's
inclined surface, thereby separating the mucosa from muscularis
Mus. Once separated, the mucosa automatically contacts resection
element 2420 and is resected by the element, for example, via a
cutting force or via RF ablation. Member 2410 may be advanced along
any desired path to resect mucosa along the path.
[0168] Although preferred illustrative embodiments of the present
invention are described hereinabove, it will be apparent to those
skilled in the art that various changes and modifications may be
made thereto without departing from the invention. For example, a
variety of energy sources optionally may be utilized to mark,
resect or otherwise manipulate tissue, including, but not limited
to lasers (pulsed or continuous), RF (monopolar, bipolar or
multipolar), high energy ultrasound, etc. It is intended in the
appended claims to cover all such changes and modifications that
fall within the true spirit and scope of the invention.
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