U.S. patent application number 13/408649 was filed with the patent office on 2012-06-28 for method and device for use in endoscopic organ procedures.
This patent application is currently assigned to Ethicon Endo-Surgery, Inc.. Invention is credited to Matthew J. Collier, Jamy Gannoe, Craig Gerbi, Gary Weller.
Application Number | 20120165843 13/408649 |
Document ID | / |
Family ID | 32179477 |
Filed Date | 2012-06-28 |
United States Patent
Application |
20120165843 |
Kind Code |
A1 |
Gannoe; Jamy ; et
al. |
June 28, 2012 |
METHOD AND DEVICE FOR USE IN ENDOSCOPIC ORGAN PROCEDURES
Abstract
Methods and devices for use in tissue approximation and fixation
are described herein. The present invention provides, in part,
methods and devices for acquiring tissue folds in a circumferential
configuration within a hollow body organ, e.g., a stomach,
positioning the tissue folds for affixing within a fixation zone of
the stomach, preferably to create a pouch or partition below the
esophagus, and fastening the tissue folds such that a tissue ring,
or stomas, forms excluding the pouch from the greater stomach
cavity. The present invention further provides for a liner or
bypass conduit which is affixed at a proximal end either to the
tissue ring or through some other fastening mechanism. The distal
end of the conduit is left either unanchored or anchored within the
intestinal tract. This bypass conduit also includes a fluid bypass
conduit which allows the stomach and a portion of the intestinal
tract to communicate.
Inventors: |
Gannoe; Jamy; (West Milford,
NJ) ; Gerbi; Craig; (Mountain View, CA) ;
Weller; Gary; (Los Gatos, CA) ; Collier; Matthew
J.; (Los Altos, CA) |
Assignee: |
Ethicon Endo-Surgery, Inc.
Cincinnati
OH
|
Family ID: |
32179477 |
Appl. No.: |
13/408649 |
Filed: |
February 29, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11713852 |
Mar 5, 2007 |
8147441 |
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13408649 |
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10351231 |
Jan 24, 2003 |
7220237 |
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11713852 |
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10279257 |
Oct 23, 2002 |
7229428 |
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10351231 |
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Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61B 17/1155 20130101;
A61B 2017/306 20130101; A61B 2017/07214 20130101; A61B 17/072
20130101; A61B 2017/2905 20130101; A61B 17/1114 20130101; A61F
5/0079 20130101; A61F 5/0086 20130101; A61F 5/0076 20130101; A61B
2017/00323 20130101 |
Class at
Publication: |
606/153 |
International
Class: |
A61B 17/11 20060101
A61B017/11 |
Claims
1. A surgical method, comprising: transorally advancing a proximal
end of a tubular member through an esophagus of a patient to
position the proximal end of the tubular member adjacent an
attachment site near a gastroesophageal junction; transorally
advancing a distal end of the tubular member through the esophagus
and through a stomach of the patient to position the distal end
adjacent an intestine of the patient; and attaching the proximal
end of the tubular member at the attachment site such that the
tubular member is configured to channel food from the esophagus
directly into the intestine by allowing the food to pass from the
esophagus into an inner lumen of the tubular member through the
proximal end of the tubular member and exit the inner lumen of the
tubular member into the intestine through the distal end of the
tubular member.
2. The method of claim 1, further comprising anchoring the distal
end of the tubular member to the intestine.
3. The method of claim 1, further comprising anchoring the distal
end of the tubular member in a pylorus of the patient.
4. The method of claim 1, further comprising implanting the tubular
member within the patient without anchoring the distal end of the
tubular member to tissue such that the distal end of the tubular
member is allowed to freely move within the patient.
5. The method of claim 1, wherein attaching the proximal end of the
tubular member at the attachment site comprises attaching the
proximal end of the tubular member distal of the esophagus.
6. The method of claim 1, further comprising transorally advancing
an endoscopic device through the esophagus, wherein transorally
advancing the proximal and distal ends of the tubular member
through the esophagus comprises advancing the tubular member over
the endoscopic device with the endoscopic device passing through
the inner lumen of the tubular member.
7. The method of claim 1, wherein attaching the proximal end of the
tubular member at the attachment site comprises attaching the
proximal end of the tubular member at the attachment site using at
least one fastening element.
8. The method of claim 1, wherein attaching the proximal end of the
tubular member at the attachment site comprises attaching the
proximal end of the tubular member at the attachment site using at
least one fastening element without creating a tissue fold.
9. The method of claim 1, further comprising forming a tissue fold
at the attachment site, wherein attaching the proximal end of the
tubular member at the attachment site comprises attaching the
proximal end of the tubular member to the tissue fold.
10. The method of claim 9, wherein the tissue fold is formed at the
attachment site simultaneously with attachment of the proximal end
of the tubular member at the attachment site.
11. The method of claim 9, wherein the proximal end of the tubular
member is attached at the attachment site after the tissue fold is
formed.
12. The method of claim 9, further comprising transorally advancing
an endoscopic device through the esophagus, wherein the tissue fold
is formed using the endoscopic device, and transorally advancing
the proximal and distal ends of the tubular member through the
esophagus comprises advancing the tubular member over the
endoscopic device with the endoscopic device passing through the
inner lumen of the tubular member.
13. The method of claim 9, wherein forming the tissue fold
comprises forming a tissue ring from tissue adjacent the
gastroesophageal junction, and attaching the proximal end of the
tubular member at the attachment site comprises attaching the
proximal end of the tubular member to a proximal side of the tissue
ring such that the tubular member passes through an inner opening
defined by a perimeter of the tissue ring.
14. The method of claim 9, wherein forming the tissue fold
comprises forming a circumferential tissue fold around a partial
circumference of the esophagus from tissue adjacent the
gastroesophageal junction, and attaching the proximal end of the
tubular member at the attachment site comprises attaching the
proximal end of the tubular member to the tissue fold.
15. The method of claim 1, wherein the tubular member is formed
from a flexible material that allows the tubular member to move
within the intestine due to peristalsis of a wall of the
intestine.
16. The method of claim 1, wherein the inner lumen of the tubular
member is free of obstructions such that the food is allowed to
freely pass through the inner lumen of the tubular member.
17. A surgical method, comprising: transorally advancing into a
patient a conduit having an unobstructed inner lumen extending
between proximal and distal ends thereof; positioning the proximal
end of the conduit adjacent a gastroesophageal junction of the
patient; positioning the distal end of the conduit within an
intestine of the patient such that an intermediate portion of the
conduit extending between the proximal and distal ends thereof is
positioned within the stomach; and attaching the proximal end of
the conduit adjacent the gastroesophageal junction using at least
one fastening element such that food can pass directly from the
esophagus into the inner lumen of the conduit through the proximal
end of the conduit, advance through the inner lumen of the conduit,
and exit the inner lumen through the distal end of the conduit to
pass directly into the intestine.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 10/279,257 filed Oct. 23, 2002, which is
incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical apparatus
and methods and more particularly to devices and methods for
dividing a hollow body organ or otherwise restricting or
partitioning a certain section of that organ, such as a stomach,
intestine or gastrointestinal tract as well as devices and methods
for placing a liner within or partially within the hollow body
organ.
BACKGROUND OF THE INVENTION
[0003] In cases of severe obesity, patients may currently undergo
several types of surgery either to tie off or staple portions of
the large or small intestine or stomach, and/or to bypass portions
of the same to reduce the amount of food desired by the patient,
and the amount absorbed by the gastrointestinal tract. The
procedures currently available include laparoscopic banding, where
a device is used to "tie off" or constrict a portion of the
stomach, vertical banded gastroplasty (VBG), or a more invasive
surgical procedure known as a Roux-En-Y gastric bypass to effect
permanent surgical reduction of the stomach's volume and subsequent
bypass of the intestine.
[0004] Typically, these stomach reduction procedures are performed
surgically through an open incision and staples or sutures are
applied externally to the stomach or hollow body organ. Such
procedures can also be performed laparoscopically, through the use
of smaller incisions, or ports, through trocars and other
specialized devices. In the case of laparoscopic banding, an
adjustable band is placed around the proximal section of the
stomach reaching from the lesser curve (LC) of the stomach around
to the greater curve (GC), thereby creating a constriction or
"waist" in a vertical manner between the esophagus (ES) and the
pylorus (PY) (See Prior Art FIG. 1). During a VBG (See Prior Art
FIG. 2) a small pouch (P) (approximately 20 cc in volume) is
constructed by forming a vertical partition from the
gastroesophageal junction (GEJ) to midway down the lesser curvature
of the stomach by externally applying staples, and optionally
dividing or resecting a portion of the stomach, followed by
creation of a stoma (ST) at the outlet of the partition to prevent
dilation of the outlet channel and restrict intake. In a Roux-En-Y
gastric bypass (see Prior Art FIG. 3), the stomach is surgically
divided into a smaller upper pouch connected to the esophageal
inflow, and a lower portion, detached from the upper pouch but
still connected to the intestinal tract for purposes of secreting
digestive juices. A resected portion of the small intestine is then
anastomosed using an end-to-side anastomosis to the upper pouch,
thereby bypassing the majority of the intestine and reducing
absorption of caloric intake and causing rapid "dumping" of highly
caloric or "junk foods".
[0005] Although the outcome of these stomach reduction surgeries
leads to patient weight loss because patients are physically forced
to eat less due to the reduced size of their stomach, several
limitations exist due to the invasiveness of the procedures,
including time, general anesthesia, healing of the incisions and
other complications attendant to major surgery. In addition, these
procedures are only available to a small segment of the obese
population (morbid obesity, Body Mass Index.gtoreq.40) due to their
complications, leaving patients who are considered obese or
moderately obese with few, if any, interventional options.
[0006] In addition to surgical procedures, certain tools exist for
approximating or otherwise securing tissue such as the stapling
devices used in the above-described surgical procedures and others
such as in the treatment of gastroesophogeal reflux (GERD). These
devices include the GIA.RTM. device (Gastrointestinal Anastomosis
device manufactured by Ethicon Endosurgery, Inc. and a similar
product by USSC), and certain clamping and stapling devices as
described in U.S. Pat. Nos. 5,897,562 and 5,571,116 and 5,676,674,
Non-Invasive Apparatus for Treatment of Gastroesophageal Reflux
Disease (Bolanos, et al) and 5,403,326 Method for Performing a
Gastric Wrap of the Esophagus for Use in the Treatment of
Esophageal Reflux (Harrison et al) for methods and devices for
fundoplication of the stomach to the esophagus for treatment of
gastro esophageal reflux (GERD). In addition, certain tools as
described in U.S. Pat. No. 5,947,983 Tissue Cutting and Stitching
Device and Method (Solar et al), detail an endoscopic suturing
device (C.R.Bard, Inc., Billerica, Mass.) that is inserted through
an endoscope and placed at the site where the esophagus and the
stomach meet. Vacuum is then applied to acquire the adjacent
tissue, and a series of stitches are placed to create a pleat in
the sphincter to reduce the backflow of acid from the stomach up
through the esophagus. These devices can also be used transorally
for the endoscopic treatment of esophageal varices (dilated blood
vessels within the wall of the esophagus).
[0007] Further, certain devices are employed to approximate tissue
such as in U.S. Pat. No. 5,355,897 (Pietrafitta) describing the use
of a circular stapler to perform a pyloroplasty to create a
narrowing at the pylorus. In addition, intraluminal anastomosis,
such as bowel anastomosis, use suturing or stapling and employ
tools such as the circular stapler, such as that described in U.S.
Pat. Nos. 5,309,927 (Welch), 5,588,579 (Schnut et al), 5,639,008
(Gallagher et al), 5,697,943 (Sauer), 5,839,639 (Sauer), 5,860,581
(Robertson et al), and 6,119,913 (Adams et al). Such circular
staplers are available from Ethicon Endosurgery, Cincinnati, Ohio
(Proximate.TM. and EndoPath Stealth.TM. staplers, see
www.surgicalstapling.com), Power Medical Interventions, New Hope,
Pa., and United States Surgical, a unit of Tyco Healthcare Group
LP, Norwalk, Conn.
[0008] There is a need for improved devices and procedures. In
addition, because of the invasiveness of most of the surgeries used
to treat obesity, and the limited success of others, there remains
a need for improved devices and methods for more effective, less
invasive hollow organ restriction procedures.
SUMMARY OF THE INVENTION
[0009] The present invention provides for improved methods and
apparatus for the transoral, or endoscopic, restriction of a hollow
body organ, such as the creation of a small stomach pouch. For
purposes of the present invention, the hollow body organ shall
include the entire gastrointestinal tract, including, but not
limited to, the esophagus, stomach, portions of or the entire
length of the intestinal tract, etc., unless specified otherwise.
In the case of the present invention, the surgeon or endoscopist
may insert devices as described below through the patient's mouth,
down the esophagus and into the stomach or intestine as
appropriate. The procedure can be performed entirely from within
the patient's stomach or other organ, and does not require any
external incision. The end result of the procedure is the formation
of a variety of organ divisions or plications that serve as
barriers or "partitions" or "pouches" that are substantially sealed
off from the majority of the organ cavity. For example, in the case
of dividing the stomach, the "pouch" or partitions that are created
may seal a small portion of the stomach just below the esophagus to
allow only small amounts of food or liquid to be consumed by the
patient. This pouch or partition will mimic the section of stomach
sealed off from the majority of the organ in a traditional obesity
surgery heretofore described; however, it can be formed and secured
entirely from inside the stomach endoscopically, obviating the need
for a prolonged procedure, external incisions, minimizing the risk
of infections, and in some cases, general anesthesia.
[0010] The methods and tools of the present invention may also be
used in treating GERD in that stomach folds just below the
esophagus can be acquired and fastened to create a desired "pleat",
thereby effectively extending the length of the esophagus and
preventing reflux. Preferably, multiple folds of tissue can be
acquired to effect this end. Further, features of the present
invention would assist in the longevity of the GE Junction
(GEJ)/Esophageal pleat as compared to current devices and
techniques as the plication would include a more significant amount
of muscular tissue. In addition, the devices and methods of the
present invention may be used to revise or repair failures seen in
current surgical procedures, such as dilation of the pouch and/or
stoma (stomata) formed in a traditional Roux-En-Y gastric bypass,
or VBG. In these cases, when the stoma dilates or shifts, the tools
of the present invention would be useful to circumferentially
gather tissue at the site of dilation to narrow it, thereby making
the stoma functional again, or by further reducing the volume of an
existing pouch which has dilated.
[0011] The devices shown and described herein can be used to form a
pouch or partition by the approximation and fixation of a circular
section of tissue acquired circumferentially from the walls of the
target organ. The tissue acquisition device and fastener may
include an acquisition feature (utilizing, e.g., a vacuum, and/or
some other mechanical method for acquiring a circumferential "bite"
of tissue), a fixation element (such as a stapling mechanism) and
possibly a cutting element. In addition, the device may be adapted
to receive a standard endoscope to allow viewing of the target
region at various points during the procedure. The devices may be
articulatable through a variety of conventional methods;
alternatively, they may be articulated by a endoscope or other
articulation device inserted within.
[0012] The fastening assembly of the present invention may employ a
similar design and function to those circular staplers heretofore
referenced, taking advantage of their ability to deploy multiple
rows of staples with one actuation, and their relative clinical
efficacy in performing other types of fastening (e.g. anastomoses
procedures, hemorrhoid plication, etc.). Such devices can be
adapted to perform the novel procedures described herein. Such
devices may be adapted to incorporate a tissue acquisition system
within the stapler body to allow sufficient tissue to be acquired
during a procedure, and other modifications may be done to enable
use of the stapler in these novel procedures.
[0013] In the procedures of the present invention relating to
treatment of gastric disorders such as gastroesophageal reflux
disease (GERD), or in cases of treating obesity, a flexible
circular stapler may be inserted transorally down the patient's
esophagus and into the stomach at the region of the GEJ. Tissue may
then be acquired circumferentially about the stapler device, or at
least partially about the circumference of the stapler device at
some point less than 360 degrees (possibly in a 180 degree
formation) relative to a longitudinal axis of the device such that
the tissue acquisition creates a "waist" within the organ volume.
Subsequently, the tissue fixation element may then be deployed to
fix the tissue in a manner to promote healing.
[0014] As set forth in U.S. patent application Ser. No. 10/188,547
filed Jul. 2, 2002, which is fully incorporated herein by reference
in its entirety, the layered tissue structure of, e.g., the
stomach, and the amount of desirable tissue acquisition and
approximation is described in further detail. The devices and
procedures of the present invention would allow the operator to
reliably acquire and secure the necessary type of tissue, such as
the muscularis, in creating the circumferential or curved tissue
plication desirable to ensure a lasting clinical result.
[0015] Any of the fastening devices described herein may employ,
e.g., bioabsorbable or biofragmentable staples or fixation element.
Such fastening devices would typically dissolve or otherwise
degrade leaving only the fixation region once the desired tissue
healing has occurred. The remaining healed tissue, now a tissue
"ring" (TR), would be sufficiently adhered or healed together to
maintain the integrity of the pouch and stoma. In addition, the
fastening devices may include coatings or other secondary features
to aid healing, such as resorbable meshes, sclerosing agents,
surgical felt, or tissue grafts.
[0016] The pouch or partitions may be created by a procedure of the
present invention to remain permanently within the stomach to
restrict it indefinitely. Alternatively, the creation of the pouch
or partitions may be reversible (e.g., once weight loss is
achieved, or reflux minimized) or revised (in the event pouch side
needs to be modified). Reversal can also be achieved via various
methods such as dilation of the restricted section, or, e.g., using
an electro-surgical device such as a bovie to cut the restricted
section to free the tissue folds. Further, if the physician so
desires, techniques of the present invention may be augmented or
assisted by the use of other techniques such as laparoscopy.
Optionally, techniques of the present invention may be combined
with other procedures such as for the treatment of GERD or the
transoral placement of a bypass prosthesis or other type of liner
in the intestine to bypass the hormonally active portion of the
small intestine, typically between the stoma to just proximal of
the jejunum. Such a liner may be placed within the orifice of a
stoma created by devices described herein or within stomas created
by various conventional procedures, as also described herein. For
present purposes, a stoma refers simply to an artificial or "man
made" narrowing within a body organ. The liner may be tubular in
construction and made to match the diameter of the stoma created by
the present invention such that they can be hooked together to
achieve the desired clinical effect. Additionally, the distal end
of the liner may also be anchored to tissue distally located from
the stoma or it may be left unanchored relying on its resilient
physical structure to avoid kinking or twisting.
[0017] Moreover, such a liner may vary in construction and in
placement within the stomach. The liner, which acts as a bypass
conduit, may also include fenestrations or openings that provide
for fluid communication between the stomach cavity (for instance,
following a bypass procedure the remaining stomach cavity is
commonly referred to as the "gastric remnant") and/or common duct
(e.g., the duct that enters the intestine at the duodenal ampulla),
and certain parts of the intestinal tract to maintain alimentary
flow of digestive secretions. Allowing such flow may facilitate in
preventing adhesions from forming between the liner and regions of
the intestines. Such adhesions may typically cause blockage of the
common duct with potentially fatal consequences, such as bowel
necrosis. The liner may also include a secondary fluid conduit
adjacently positioned along the liner to provide for fluid
communication. The fluid conduit may thus have a length which is
less than, greater than, or equal to a length of the liner and
sufficient to communicate from the inflow point (e.g., gastric
remnant or duodenal ampulla) and a point in the lower intestine
(e.g., near the jejunum). The liner and fluid conduit may also be
configured to ensure that the liner and/or fluid conduit does not
inhibit fluid communication from the common bile ducts, such as
channels or fenestrations along their length. The fluid conduit may
be attached to the liner as a parallel tube or in any number of
configurations. Another variation may have the fluid conduit as a
coaxial tube positioned about the liner.
[0018] In either case, the liner may define one or more
fenestrations or channels on the portion of the liner in
communication with the gastric remnant, and/or at or near the site
of the common bile ducts so as to allow fluids to drain from the
organ or ducts. The liner and the fluid conduit may be made
separately and attached together or they may be made integrally
from the same material. Also, the liner and/or the fluid conduit
may be made of a braided design to inhibit kinking as the device
reacts to the peristalsis motion of the intestines. Another
alternative may utilize a singular liner having one or more
channels defined longitudinally along the outer surface of the
liner rather than as a separate fluid conduit. These channels may
form spaces between the tissue and the liner itself to allow for
the flow of fluids within the channels. In another variation of the
singular liner, the liner may have fenestrations or openings
positioned along its length near or at the zones of active
secretion in the intestines to permit fluid flow from the organ or
bile ducts into the lumen of the liner (so as to prevent blockage
thereof), while still maintaining a barrier to the majority of the
intestine to achieve malabsorption and to facilitate "dumping"
syndrome upon ingestion of high fat or high caloric foods. An
alternative variation of this singular liner may have multiple
valved openings along its length to allow for the unidirectional
flow of secretions into the liner, but prohibiting contact between
the intestines and the food contents within the liner.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 depicts the prior art procedure commonly known as
laparoscopic banding;
[0020] FIG. 2 depicts the prior art procedure commonly known as the
vertical banded gastroplasty or "VBG";
[0021] FIG. 3 depicts the prior art procedure commonly know as
surgical Roux-En-Y procedure;
[0022] FIG. 4A-4B depicts one variation on a procedure of the
present invention, showing a cut-away section of the tissue being
acquired by the distal tip of the device of the present invention,
and the resulting modification to the body organ (creation of a
"pouch" within the stomach);
[0023] FIGS. 5A-5D depict one variation of procedural steps of
performing the methods of the present invention, by showing a cross
section of an organ (stomach) and the placement of the device to
create a narrowing or "pouch" within the organ;
[0024] FIG. 5E depicts one variation of a result of the present
invention, including a bypassing sleeve installed to bridge from
the point of the stoma at the GEJ, to the pylorus, or further into
the intestine.
[0025] FIGS. 6A-6D shows a schematic depiction of an organ
(stomach) following completion of one variation on a procedure of
the present invention and the resulting cross sectional view of the
treated region in various configurations;
[0026] FIGS. 7A-7F show a variation on the circular tissue
acquisition and fixation device of the present invention, including
details on the inner working elements and flexible shaft
thereof;
[0027] FIG. 8 depicts details of one variation on the distal
portion of the circular tissue acquisition and fixation device of
the present invention showing an angled annular acquisition
space;
[0028] FIG. 9 depicts another variation of the tissue acquisition
mechanism of the circular tissue acquisition and fixation device of
the present invention;
[0029] FIGS. 10A-10B depict variations of the distal working end of
the distal tip of the circular tissue acquisition and fixation
device of the present invention, detailing an anvil designed to be
intraprocedurally manipulated to assist in removal of the circular
tissue acquisition and fixation device of the present invention
once the desired tissue has been acquired and fixed according to
the present invention.
[0030] FIG. 11A depicts a variation of a bypass conduit
assembly.
[0031] FIGS. 11B-11E depict variations on possible cross sections
of the bypass conduit assembly.
[0032] FIG. 11F depicts a variation of the bypass conduit assembly
having an irregular cross section.
[0033] FIG. 12 depicts another variation of the bypass conduit
assembly but with the addition of a fluid bypass conduit located
adjacent the conduit wall.
[0034] FIGS. 13A-13B depict perspective and cross-sectional views,
respectively, of another variation of the bypass conduit having a
coaxial fluid bypass conduit.
[0035] FIG. 14 depicts a perspective view of a braided tubular
structure which may be utilized for the bypass conduit.
[0036] FIGS. 15A-15B depict variations on anchoring devices for the
bypass conduit.
[0037] FIGS. 16A-16B depict a bypass conduit with a fluid bypass
conduit deployed within a stoma created by a laparoscopic banding
procedure.
[0038] FIGS. 17A-17B depict a bypass conduit with a coaxial fluid
bypass conduit deployed within a stoma created by a laparoscopic
banding procedure.
[0039] FIGS. 18A-18B depict a bypass conduit with spaced apart
fenestrations deployed within a stoma created by a vertical banded
gastroplasty procedure.
[0040] FIGS. 19A-19B depict a bypass conduit having valved
fenestrations deployed within a stoma created by laparoscopic
banding to constrict the stomach cavity and create a stoma.
[0041] FIGS. 19C-19F depict variations on maintaining fluid
communication through or along the bypass conduit.
[0042] FIGS. 20A-20B depict a bypass conduit deployed within a
stomach which has an intragastric staple line.
[0043] FIGS. 21A-21B depict a bypass conduit deployed within a
stoma created by a horizontal gastroplasty procedure.
[0044] FIGS. 22A-22B depict a bypass conduit deployed within a
stoma created by a biliopancreatic diversion procedure.
DETAILED DESCRIPTION OF THE INVENTION
[0045] The present invention provides, in part, for methods and
devices for hollow organ division and restriction, more
particularly providing methods and devices to perform a transoral,
endoscopically mediated stomach reduction for purposes of, e.g.,
treating obesity. For purposes of the present invention, the hollow
body organ shall include the entire gastrointestinal tract,
including, but not limited to, the esophagus, stomach, portions of
or the entire length of the intestinal tract, etc., unless
specified otherwise.
[0046] As previously discussed, the results of some clinical
procedures of the prior art are shown in FIGS. 1-3, from a
perspective external to the stomach. An example of a result of the
procedure in one variation of the present invention is shown in
FIG. 4A, which depicts an external anterior view of a stomach organ
100, having an esophagus 101 (cut away to reveal the esophageal
lumen 102), and further depicting a circumferential orifice or
stoma 103, configured from staple line 104, producing a pouch (P).
Orifice 103 is preferably positioned close to and on the distal
side of the gastroesophageal junction (GEJ) at the base of the
esophagus, and angled toward the lesser curve of the stomach (LC),
leaving a stoma or opining having a diameter of approximately 1 cm
between the pouch (P) and the remaining stomach volume. A desirable
pouch (P) volume is between 15-100 cc, preferably 15-20 cc. The
orifice 103 operates to restrict food from emptying from the pouch,
while still allowing communication between the pouch and the
greater stomach volume for purposes of passage of digestive fluids
and secretions and absorption of nutrients. FIG. 4B depicts an
example of a cross sectional view of the esophagus where it joins
the stomach, and further depicts one variation of a tissue
acquisition device of the present invention 105, actively engaging
the tissue to be fastened in a circumferential fashion.
Method of Hollow Organ Volume Reduction
[0047] A clinical work-up, including a physical and mental
assessment of the patient may be performed to determine whether a
transoral stomach reduction clinically indicated. This assessment
may include inspecting the esophagus and stomach of the patient to
determine whether any contraindications exist for undertaking the
procedure such as ulcerations, obstructions, or other conditions
that may preclude treatment. Once the assessment has been
completed, either in an operating room with the patient under
general anesthesia, or in an endoscopy suite with the patient under
sedation, the operator can introduce a tissue acquisition and
fixation device, as shown in FIGS. 5A-5D, down the patient's
esophagus and into the stomach to a location just beyond the GE
Junction (GEJ). Once in place, an optional calibration device (not
shown) such as a balloon or bougie can be inflated or deployed
proximally or adjacently to the GE Junction (GEJ) to assist in
correctly sizing the pouch to be created. Alternatively, the
physician may opt to use direct vision and place an endoscope
through the main lumen of the tissue acquisition device to view the
site of entry and resultant treatment zone.
[0048] FIGS. 5A through 5D depict cross sectional schematic views
of the procedure of the present invention showing tissue being
manipulated within a hollow organ, the stomach. FIG. 5A depicts the
esophagus (ES) the stomach cavity (SC), including the landmarks of
the lesser curve of the stomach (LC), the gastroesophageal junction
(GEJ), and the pylorus (PY). Tissue layers represented are the
serosal layer (SL), the muscularis or fibrous muscular layer (ML),
and the mucosal layer (MUC). Further, FIG. 5A shows the tissue
acquisition device 105 positioned within the esophagus at a
location within the stomach cavity (SC) between the lesser curve
(LC) of the stomach and the GEJ.
[0049] The device 105, includes a main body 106 having at least one
lumen therethrough (not shown), an outer portion 107, having a
distal end 108 containing a fixation mechanism and a proximal end
(not shown). The device 105 further comprises an inner portion 109,
which has a distal portion 110 containing a fixation mechanism and
a proximal portion (not shown) received therein. Once device 105 is
positioned in the preferred anatomical location, outer portion
distal end 108 and inner portion distal end 110 are separated by
relative movement of inner portion 109 within outer portion 107, to
expose opening 112. As described in further detail later below,
opening 112 is operatively connected to at least one lumen within
the main body 106 and provides a force, e.g., a vacuum force, to
facilitate tissue acquisition. Such a force may be provided by a
vacuum or by a mechanical element.
[0050] As shown in FIG. 5B, in the case of vacuum, once the opening
112 is exposed to the surrounding tissue within the stomach cavity
(SC), the vacuum may be activated and tissue 111 may be drawn into
the opening 112 in an entirely circumferential manner or a
substantially circumferential manner, i.e., at least partially
about the circumference of the device at some point less than 360
degrees (possibly in a 180 degree formation) relative to a
longitudinal axis of the device. The amount of tissue 111 acquired
can vary, but the amount drawn is preferably sufficient enough to
result in healing of the fastened sections, thereby creating a
tissue ring (TR) around the circumference of the fastened tissue.
Said tissue ring may be formed of various layers of the stomach and
may include scar tissue and other elements of effective wound
healing.
[0051] FIG. 5C further depicts the device 105 after the desired
amount of tissue 111 has been acquired, outer portion distal end
108 and inner portion distal end 110 may be moved towards one
another such that the acquired tissue 111 is clamped therebetween.
Device 105 is then actuated to engage at least one fastening
element (not shown) through the acquired tissue 111 thereby
fastening it in place in a circumferential fashion. This fastening
step may also include a cutting step to score or otherwise abrade
the acquired tissue 111 after it is fastened to enhance the healing
response of the tissue 111 to increase the durability of the tissue
ring. In addition, bulking agents, such as collagen, may be
injected at the time the stoma is formed, or thereafter, to aid in
healing and durability of the tissue. Once the tissue 111 has been
fastened or fixed, the tissue acquisition device 105 is then
removed. In doing so, the inner portion distal end 110 of the
device may be carefully pulled through the newly-created tissue
ring or stoma created by the procedure so as to minimize stretching
of the ring or stoma. Finally, FIG. 5D depicts the stomach showing
the final result and placement of a circumferential tissue ring
(TR) or stoma (ST).
[0052] As depicted in FIG. 5E, it is also contemplated that the
procedural steps described above may be followed by the placement
of an optional bypass conduit 113 to create a bypass from the newly
created pouch (P) directly to the pylorus (PY) or beyond into the
small intestine. Such a bypass would channel food directly from the
pouch (P) into the small intestines to achieve a malabsorptive
effect in cases where such an effect may enhance weight loss. Such
a bypass conduit 113 may be formed of any suitable biocompatible
graft material such as polyester or PTFE, and may be secured to the
newly created tissue ring (TR) or stoma (ST) endoscopically using a
clip or stent like structure at the anchored end to produce an
interference fit within the stoma. Alternatively, the bypass
conduit could be placed over the acquisition device of the present
invention, and secured by the same fastening elements, and at the
same time as the formation of the stoma. In doing so, the end of
the bypass graft to be anchored may be placed over the tissue
acquisition device such that the end of the graft coincided with
the tissue acquisition device opening 112, allowing it to be
acquired into the device and fastened along with the surrounding
tissue. Similarly, the bypass conduit may be anchored in the
pylorus (PY) or intestine by similar methods, or may just be left
unanchored in the intestine to allow for movement due to
peristalsis of the intestinal wall.
[0053] FIGS. 6A-6D depict variations of the tissue rings and
pouches created using the method, and variations thereof, described
herein. FIGS. 6A and 6B depict the results of utilizing the
procedure described above, showing a complete circumferential ring,
in this variation, created just distal from the where the esophagus
(ES) and the stomach join each other. FIG. 6B shows a cross section
of the stomach and tissue ring (TR) and further depicts the
resulting tissue folds 114 acquired by the device 105 and the
fixation elements 115 deployed to fix the acquired tissue. This
cross section further depicts a cut zone or abraded zone 116 as
described above. FIGS. 6C and 6D depict another variation in which
fixation of the acquired tissue in a position centered between the
lesser curve of the stomach (LC) and the greater curve (GC) in such
a manner that multiple lumens 117, 118 result as shown in FIG. 6D.
Although only two additional lumens 117, 118 are shown in this
variation, a number of lumens may be created in other variations
depending upon the number of times and positions the tissue is
affixed.
[0054] One method of the present invention is to use the device
105, or a variation thereof, to modify or otherwise assist in other
procedures that utilize stomach or organ plication such as those
described in co-pending U.S. patent application Ser. No. 10/188,547
earlier incorporated herein by reference, which describes, in part,
in further detail methods and devices for stapling regions of the
stomach in a linear fashion. In cases where a zone of the stomach
is linearly stapled, the device 105 may be employed to create
circular stomas at either end of the linear staple line so as to
enhance the efficacy of a volume reduction procedure or to enhance
durability of the staple line. It may also be advantageous to place
semi-circular or partially circumferential fixation zones at
various locations within the target hollow organ. The devices and
methods described herein are particularly well-suited for this
because of their ability to "gather" the tissue and create a
circumferential restriction that acts to limit the flow of matter,
such as food, through the organ.
Devices
[0055] FIG. 7 depicts a cross-sectioned view of one variation of
tissue acquisition device 120. As shown, device 120 has a main body
portion 123 which has a proximal end, a distal end, and a main
lumen 121 defined therethrough. Device 120 also has a grip portion
122' and an opposing handle portion 122 which may be pivotally
attached to main body portion 123 such that handle portion 122 is
angularly positionable relative to grip portion 122'. Main body
portion 123 may further define one or more circumferentially
defined lumens along its length such that these lumens terminate at
the distal end of body portion 123 at outer distal portion 124.
Main body portion 123 further houses main body inner portion 125,
which may be an elongate tubular member configured to be slidably
positioned within main body lumen 121 defined through the length of
main body portion 123. At the distal end of inner portion 125, an
inner body distal portion 126 may be attached thereto. This distal
portion 126 may be integrally formed onto inner portion 125 or
attached separately and may be used as a clamping member to
facilitate the mechanical retention of tissue invaginated into the
device 120. Distal portion 126 may also function as an anvil for
reconfiguring fastening members inserted into the tissue, as
further described below. The proximal end of inner portion 125 may
terminate proximally of main body portion 123 in a fluid port 127,
which may be utilized for fluid connection to, e.g., a vacuum pump
(not shown). Alternatively, distal portion 126 may function as the
staple housing and outer distal portion 124 may function as the
opposing anvil. In this variation, the fasteners, as positioned
within distal portion 126, may be deployed through inner face 128
into the tissue using an actuation device, as known in the art.
[0056] Inner body distal portion 126 may further comprises an inner
face 128 which may define an anvil or fastener element detent 129.
Where inner portion 125 joins with distal portion 126, one or more
distal ports 132 may be defined which are in fluid communication
through inner portion 125 with fluid port 127. To actuate device
120, handle portion 122 may be urged to pivot relative to grip
portion 122'. Slider pins 130 may be fixedly attached to main body
inner portion 125 and configured to extend perpendicularly relative
to inner portion 125, as shown in FIG. 7B. Pins 130 may be
operatively connected with handle 122 such that rotation or
movement of handle 122 is translated into the linear motion of
inner portion 125. Pins 130 may be positioned within slot 131 which
are defined longitudinally within main body portion 123. Slots 131
may be configured to allow limited translational movement of pins
130 thereby limiting the overall translational distance traveled by
inner portion 125.
[0057] Actuation of handle 122 in a first direction may urge pins
130 to slide within slots 131 a first direction, e.g., distally,
thereby moving inner portion 125 distally, and actuation of handle
122 in a second direction may urge pins 130 to slide in a second
direction, e.g., proximally, thereby moving inner portion 125
proximally. Main body inner portion 125 may be actuated to linearly
move inner body distal portion 126 relative to outer distal portion
124 to a desired distance between the two. When the two portions
124, 126 are moved into apposition to one another, a
circumferential tissue acquisition chamber or space 200 may be
created about or defined between the outer surface of inner portion
125, inner distal portion 126, and outer distal portion 124. Space
200 may be in fluid communication with distal port 132 and/or
optionally through main body lumen 121. In operation, a vacuum
force may be applied through distal port 132 and/or main body lumen
121 to invaginate or draw tissue into space 200 such that the
tissue is held or configured to then receive at least one fastening
element to affix the tissue configuration.
[0058] Main body portion 123 may further house driver element 133
within circumferentially-shaped fastener lumen 134. Driver element
133 may be a tubularly shaped member which is configured to
traverse longitudinally within fastener lumen 134. Disposed
distally of driver element 133 within fastener lumen 134 are
fasteners 135 and fastener pusher mechanism 136. Fasteners 135 may
comprise any variety of staples or mechanical fasteners which are
made from a biocompatible material, e.g., stainless steel,
platinum, titanium, etc., and fastener retention mechanism 136 may
also comprise any variety of staple retainer which is configured to
hold fasteners 135 within fastener lumen 134 until fasteners 135
have been pushed or urged out of the lumen 134 and into the tissue.
The proximal end of driver element 133 abuts driver actuator 137 in
handle portion 122. Handle portion 122 may define a threaded cavity
138 at its proximal end which is configured to correspondingly
receive and is in operative communication with driver actuator 137,
which may also define a threaded insertion surface for mating with
threaded cavity 138. In operation, upon tissue acquisition within
circumferential space 200 and approximation of main body inner
distal portion 126 and main body outer distal portion 124, driver
actuator 137 may be rotated in a first direction so as to matingly
engage the threads of handle portion threaded cavity 138 and
thereby engage the proximal end of driver element 133 to cause
driver element 133 to move distally. As driver element 133 is
advanced longitudinally in a corresponding manner as driver
actuator 137 is rotated, the distal end of driver element 133 may
contact fastener pusher mechanism 136 and actuating fastener 135 to
distally advance and deploy fastener 135 into any acquired
tissue.
[0059] Main body portion 123 may be bendable as depicted in FIG.
7C. As shown, the device 201 may be seen in one configuration in
which main body portion 123 may be configured in an infinite number
of different configurations for negotiating pathways within a body.
This particular variation 201 shows handle grip 202 having an
opposing actuation handle 203 for actuating movement of inner body
distal portion 126. Also shown is an optional scope lumen 204 in
the handle 202 which may be used for visualizing the tissue region
being treated during deployment or actual treatment. The
flexibility of the main body portion 123 may be imparted, in part,
by the use of, e.g., linking multiple rings 211, as shown in the
isometric view in FIG. 7D. A portion 210 of the main body 123 is
shown with the covering, control mechanisms, etc., omitted for
clarity. Although this variation shows the use of stacked multiple
rings, other variations may also be used as known in the art for
flexible and/or articulatable elongate devices, e.g., endoscopes,
etc. A plurality of individual rings 211 may be aligned with one
another to create a length of the main body portion 123. Any number
of rings 211 may be used depending upon the overall desired length
of the device or the desired length of a flexible portion of the
device. Each of the rings 211 may have at least one main channel or
lumen 212, which when individual rings 211 are aligned as a whole,
create a main channel throughout the length of the device. Each of
the rings 213 may also have a number of spacers or protrusions 213
defined on or around the circumference of the device for creating
pivotable sections for facilitating relative motion between
adjacent rings 211, as known in the art. Although the rings 211 are
shown with two oppositely positioned protrusions 213, any number of
protrusions 213 may be used as practicable depending upon the
degree of relative motion desired between adjacent rings 211.
Alternatively, device main body 123 may be constructed in part of,
e.g., a coil spring, to achieve a similar functional result. Coil
springs may be made of superelastic materials, e.g., nitinol, or
spring steels made, e.g, from stainless steels. The main body 123
or main body segments may be constructed of various biocompatible
materials, such as stainless steel, Delrin or other engineering
thermoplastics, etc.
[0060] FIG. 7E depicts a single ring 211 having the main lumen 212
defined therethrough. Main lumen 212 may be modified and enlarged
to provide a channel having a large enough diameter to receive a
conventional endoscope for possible use with the present device.
One example of such a device may have a lumen diameter of, e.g., 10
mm, with an outer diameter of, e.g., 18 mm. One or more of such
lumens may be created within the annular section 211 to enable
linkage of each section 211 to one another by one or several cables
or flexible wires (not shown) adapted to be positioned through the
lumens. These wires or cables may be routed through the length of
the device and fixed at the proximal end of the main body portion
123.
[0061] As shown in FIG. 7F, an optional sheath or thin film 221 may
be placed over the device or at least along a portion 210 of the
device to encapsulate the linkages and create a smooth shaft
surface, while still maintaining its flexibility. The sheath or
thin film 221 may be made of a variety of biocompatible materials,
e.g., heatshrink polymers, plastics, etc.
[0062] FIG. 8 depicts another variation on the distal end of a
tissue acquisition device. The inner distal portion 230 is shown
defining an inner face 231 and device outer distal portion 232
having an inner face 233. The inner distal portion inner face 231
and the outer distal portion inner face 233 may be formed to face
one another in apposition and both faces 231, 233 may each be
formed at an angle (A) relative to a longitudinal axis of the
device main body 123. The angle (A) may range anywhere from 0-90
degrees, but is preferably in the range of 15-45 degrees, depending
on the desired angle of the resulting tissue fixation zone. This
variation may be used to allow the operator to position the tissue
acquisition device perpendicularly to a surface of the organ to be
treated (for ease of use) while acquiring and fixing the tissue at
an angle relative to the tissue surface. In doing so, the operator
may fashion the resulting fixation zone to more closely approximate
a curvature of the organ, such as the curvature between the GEJ and
the LC of the stomach. FIG. 9 depicts a further variation 240 of
the tissue acquisition device in which fenestrations or ports 241
may be defined over the surface of the device inner distal portion
242. Additional fenestrations or ports 243 may be defined over a
portion of the device outer distal portion 232, and additional
fenestrations or ports 244 may also be defined over a surface of
body inner portion 245. These additional ports may allow this
variation 240 to acquire tissue along a length of the distal end of
the tissue acquisition device 240 at multiple locations therealong.
In practice, this method of tissue acquisition may allow the
operator some freedom to manipulate the acquired tissue by the
relative movement of device inner distal portion 242 and the device
outer distal portion 232. This technique can also assist in
positioning the tissue to be fixed, and/or assuring that the
required amount of tissue (e.g. some muscular layers of the organ
wall), have been uniformly acquired prior to fixation.
[0063] Following fixation, the tissue acquisition device of the
present invention is withdrawn from the organ. In doing so, care
should be used not to over-dilate or stretch the newly created
tissue ring or stoma. To mitigate any dilation or stretching, the
inner distal portion may also be modified. FIGS. 10A and 10B depict
variations 250, 260 of the tissue acquisition inner distal portion
that are adaptable to effectively reduce in cross sectional area to
allow for easier removal of the tissue acquisition device from the
organ once the circumferential fixation zone has been created. FIG.
10A depicts tissue acquisition device inner distal end 251 which is
pivotally mounted on main body inner portion 253 about pin 252.
Activation of the pivoting action may be controlled by release of
an interface between pin 252 and a stay (not shown) housed within
main body inner portion to activate rotation of inner distal end
251, e.g., in a direction 256. The inner distal end 251 may be
rotated by any angle such the inner face 254 is angled or parallel
relative to the longitudinal axis 255 of the device.
[0064] FIG. 10B depicts another variation 260 on tissue acquisition
inner portion distal end which may have a segmented configuration.
In this variation 260, the inner portion distal end may be made of
a plurality of individual segments 262 which when collapsed,
reduces the diameter of inner portion distal end to facilitate
removal. Thus, during tissue acquisition and/or fixation, the
expanded inner distal portion 264 may be utilized and after the
procedure, it may then be compressed radially 265 about a pivot 263
to reduce the cross-sectional profile for removal from the
area.
Additional Bypass Conduit Devices
[0065] As mentioned above for FIG. 5E, an optional bypass conduit
113 may be placed within the stomach cavity (SC) at the site of the
narrowing or stoma (ST). Such a conduit may be placed not only in
conjunction with the intragastric staple line described herein, but
with various other conventional procedures to create a bypass from
the pouch (P) directly to the pylorus (PY), or beyond into the
small intestines to effect the rate at which food is metabolized.
It may also further enhance the efficacy of a bariatric procedure
by facilitating "dumping syndrome". One variation on the bypass
conduit is seen in FIG. 11A in bypass conduit assembly 270. In this
variation, assembly 270 comprises a conduit wall 272, which may be
tubular in shape. Bypass lumen 274 may be defined throughout the
length of conduit wall 272. The conduit wall 272 may extend between
a proximal end 271 and to a distal end 273 and may be made from a
variety of biocompatible materials. For instance, conduit wall 272
may be made from a rubber material or from a polymeric material
which may be configured to be lubricious, e.g., Teflon, Nylon,
Dacron, PTFE, polyethylene, polystyrene, polyurethane, polyethylene
terephthalate, etc.
[0066] To further increase the structural resiliency of the conduit
wall 272, an optional reinforcing member 278 may be utilized within
the structure. Reinforcing member 278 may include any number of
structural enhancements such as a coil member as shown in the FIG.
11A. The coil member may be wound in a helical manner along the
body of conduit wall 272 either along the entire length or a
portion of the length of conduit wall 272. Another variation may
have wires positioned longitudinally along conduit wall 272 rather
than a coiled member. Alternatively, a wire-framed structure may be
utilized along the conduit wall 272.
[0067] In any of these structural enhancements, the reinforcing
member 278 may be disposed in a laminate structure between layers
of conduit wall 272 material. Alternatively, the reinforcing member
278 may be formed integrally into the conduit wall 272 by forming
the conduit material about the member 278. Another variation may
have reinforcing member 278 adhered onto the outer and/or inner
surface of the conduit wall 272 through the use of adhesives,
sutures, clamps, or any other number of conventional attachment
methods. Moreover, these optional structural enhancements may be
utilized not only in the variation shown in FIG. 11A, but in any of
the other variations described herein depending upon the desired
structural characteristics.
[0068] The proximal end 271 may be affixed or secured to the
stomach tissue within stomach cavity (SC), to the tissue adjacent
to pouch (P), or to other tissue, as further described below. In
the present variation, conduit assembly 270 may have a first gasket
275 and a second gasket 276 positioned distal of the first gasket
275 along wall 272. Gaskets 275, 276 may be made of a rubberized
material or a polymeric material configured to be flexible during
the deployment of assembly 270. Such a gasketed assembly 270 may be
used in conjunction with the tissue ring (TR) or stoma (ST), as
described in detail above. Upon deployment and positioning of
assembly 270 within the stomach cavity (SC), these gaskets 275, 276
may be allowed to expand such that first gasket 275 is located
proximally of the stoma (ST) and second gasket 276 is located
distally of the stoma (ST). A portion of the conduit wall 277
located inbetween the gaskets 275, 276 may be in contact with the
stoma (ST) and may be sufficiently flexible to form around the
stoma (ST).
[0069] When the bypass conduit is properly positioned to extend
from the narrowing, e.g., the stoma, to within the intestinal
tract, e.g., to the jejunum or farther, the distal end of the liner
may be positioned to extend distally of the duodenal ampulla 323.
As explained in further detail below, the duodenal ampulla is a
duct which connects the common bile duct and the pancreatic duct to
the duodenum for discharging digestive fluids into the duodenum.
These fluids (alimentary flow) normally intermix with partially
digested food from the stomach cavity (SC). To facilitate such
fluid exchange and to prevent the duct from being blocked by the
liner, the liner may include communications to the inside of the
liner, such as fenestrations, or channels alongside the liner
wherein the cross section of the liner may be varied to allow such
an exchange.
[0070] FIGS. 11B-11E show variations of cross sections of the
bypass conduit from FIG. 11A which may allow for fluid exchange to
occur along the outer surface of the liner. FIG. 11B shows one
variation in which the conduit wall 272' defines one or more
longitudinal channels 279 along the outer surface of the wall 272'.
FIGS. 11C and 11D show variations in which the conduit walls 272'',
272''', respectively, are angled such that the contact between the
outer surface and the tissue is non-continuous, thereby allowing
fluids to seep within or along these spaces or channels created
between the angled outer surface and the tissue. FIG. 11E shows yet
another variation in which the conduit wall 272'''' defines an
undulating outer surface forming at least one or more longitudinal
channels 279. These examples of possible irregularly defined cross
sections are merely illustrative and are not intended to be limited
only to these examples. Other variations, as should known to those
in the art, are intended to be included herewithin.
[0071] As shown in FIG. 11F, these irregular cross sectional areas
may extend along the entire length of the conduit wall 272' or just
partially along the conduit wall 272', as shown. The length of the
irregular cross section may extend just from within the body organ
to distal of the body organ, or along any desired length of the
conduit wall 272', depending upon the desired results.
[0072] Another variation on the bypass conduit is shown in FIG. 12
in conduit assembly 280. This variation is similar to that shown in
FIG. 11A but with the addition of a fluid bypass conduit 281
located adjacent to conduit wall 272. The fluid conduit 281 has a
proximal end 282 for positioning within the stomach cavity (SC) and
a distal end 283 for positioning within the intestines distal to
the stomach cavity (SC), as described in further detail below.
Fluid conduit 281 may be made in a variety of ways; for instance,
conduit 281 may be manufactured separately from conduit wall 272
and attached to the outer surface of the conduit wall 272 using any
variety of methods, e.g., adhesives, clamping, etc., in which case
conduct 281 may be made from a similar or same material as conduit
wall 272. For instance, fluid conduit 281 may be made of a braided
material, as described above, to inhibit kinking of the conduit.
Alternatively, conduit 281 may be formed integrally with the
conduit wall 272 as a uniform assembly.
[0073] In either case, conduit 281 has a length which is typically
coterminous with the length of the main conduit wall 272 but may be
less than or greater than the length of the main conduit. The
conduit 281 may also be configured such that the conduit 281
doesn't block the alimentary flow from the ducts. The distal end
283 of the conduit 281 may thus terminate proximally of the distal
end 273 of the conduit wall 272, or it may optionally terminate at
or distally of the distal end 273, depending upon the desired
structure and use. Although a single fluid conduit 281 is shown in
the figure, any number of additional fluid conduits may be
incorporated into the assembly. These additional fluid conduits may
be aligned in parallel with conduit 281 or positioned variously
about the circumference of the conduit wall 272. Moreover, the
additional conduits may be made of various lengths depending upon
the desired results. Furthermore, although fluid conduit 281 is
shown as being parallel with main conduit wall 272, fluid conduit
281 may be positioned about conduit wall 272 in a helical or spiral
manner, or it may be positioned in a variety of ways, e.g., such as
a bent or hooked proximal end, etc.
[0074] Yet another variation is shown in FIGS. 13A and 13B, which
show conduit assembly variation 290. This variation incorporates a
fluid bypass conduit 291 which is coaxially positioned about a
portion of conduit wall 272. Fluid conduit 291 has a proximal end
292 for positioning within the stomach cavity (SC) and a distal end
294 for positioning distally of the stomach cavity (SC). To
maintain the coaxially adjacent lumen 295, support struts 293 may
be positioned between fluid conduit 291 and conduit wall 272, as
seen in FIGS. 13A and 13B, which is a cross-sectional view taken
from FIG. 13A. Support struts 293 may be positioned
circumferentially between fluid conduit 291 and conduit wall 272 in
a variety of configurations so long as coaxial lumen 295 is
substantially unobstructed. Support struts 293 may be fabricated
separately or integrally with conduit wall 272 and/or fluid conduit
291. Alternatively, struts 293 may be extensions of a laminated
wireframe making up the tubular structure for conduit wall 272
and/or fluid conduit 291.
[0075] Conduit wall 272 and/or any of its auxiliary fluid conduits
may be directly fabricated from various materials, as described
above. Alternatively, they may be fabricated from an underlying
braided tubular structure such as that shown in bypass conduit
variation 300, as seen in FIG. 14. The walls of the conduit may be
made of a braided material to form a braided tubular structure 304
defining a bypass lumen 302. The braided structure 304 may be made
to make the assembly 300 more resistant to kinking, as is generally
known in the art. The tubular structure 304 may be made, for
instance, from superelastic materials like Nickel-Titanium alloys
(nitinol) or from a metal such as stainless steel. Such
construction may allow for the tubular structure 304 to be bent and
twisted 308 in an infinite manner so as to allow the structure 304
to flex and move with the stomach without kinking or obstructing
flow through the conduit. The braided structure 304 may be coated,
covered, or laminated with a biocompatible material to aid in its
lubricity; any variety of materials may be used, e.g., polymeric
materials such Teflon, Nylon, Dacron, PTFE, polyethylene,
polystyrene, polyurethane, polyethylene terephthalate, etc.
[0076] To aid in the secure placement of the bypass conduit
proximal to or within the stomach cavity (SC), the proximal end 301
of the conduit 304 may optionally be radially flared 305 such that
the flared portion 305 securely contacts the tissue. The flared
portion 305 may optionally be reinforced, either by additional
braiding or an additional structural ring or band, to create a
reinforced region 307 for further ensuring adequate structural
support. Moreover, the distal end 303 may also be optionally flared
306 to assist in anchoring the distal end of the bypass conduit
within the intestinal tract or distal to the stomach cavity
(SC).
[0077] To further facilitate anchoring of a bypass conduit, a
number of alternative anchors may be utilized aside from the
gasketed configuration described above. Another variation is shown
in FIG. 15A in conduit anchoring variation 310. As seen, conduit
wall 311 may have a first gasket 312 and an optional second gasket
313 in which each gasket 312, 313 may comprise a coil which is
biased to extend radially outward. As above, first and second
gaskets 312, 313 may be separated by a conduit portion 314 and a
partial length or the entire length of the conduit wall 311 may be
reinforced with a reinforcing member 319, as described above.
[0078] Another alternative variation to facilitate the anchoring of
the bypass conduit may be seen in variation 315 in FIG. 15B.
Conduit anchoring variation 315 may have a reinforced portion or
section 317 located near or at the proximal did of conduit wall
316. This reinforced section 317 may comprise a radially expanding
portion, much like a self-expanding stent made of a shape memory
alloy such as nitinol; alternatively, section 317 may also comprise
a prosthetic ring or gasket made of a polymeric material.
Attachment points 318 may be optionally included to project from
the proximal end of conduit wall 316 or from the reinforced section
317. These attachment points 318 may be configured to pierce into
the tissue and aid in affixing the conduit 315 by helping to hold
the conduit 315 securely in place along the tissue. The attachment
points 318 may be positioned around the circumference of the
conduit wall 316 or in any number of configurations as is known in
the art. Although the figure shows attachments points 318 as hooks,
any number of different configurations may be utilized, e.g.,
barbs, clamps, sutures, staples, stents, bands, adhesives, etc.,
may also be used.
Bypass Conduit Placement
[0079] The bypass conduit may be positioned between the stomach
cavity (SC) and the intestines in a variety of ways aside from that
shown in FIG. 5E above. The bypass conduit assembly 280 may be used
in conjunction with various gastric procedures. As seen in FIG.
16A, bypass conduit assembly 280 may be used with a stomach (SC)
which has undergone a laparoscopic banding procedure. FIG. 16B
shows a view of a lap band 321 which has been positioned around a
portion of the stomach cavity (SC) below the esophagus (ES) prior
to having a bypass conduit deployed. FIG. 16A shows a view of
assembly 320 in which conduit assembly 280 has been positioned to
extend from the stoma (ST) created by the banding, to a point past
the pylorus (PY). As shown, the proximal end 271 of the conduit
assembly 280 may be secured within the stoma created by the lap
band 321 using any of the methods described above. The conduit wall
272 is appropriately sized such that it extends through the stomach
cavity (SC) from, in this variation, the stoma (ST) into the
intestines, e.g., the duodenum 322, although the distal end 273 may
extend farther into the intestinal tract, e.g., to the jejunum. The
distal end 273 of the conduit wall 272 may be left unanchored in
the intestinal tract or it may be optionally anchored to the
tissue. Anchoring of the distal end 273 may be achieved using any
of the anchoring methods as described above for anchoring of the
proximal end 271.
[0080] The fluid conduit 281 may be seen in this variation as being
positioned along the conduit wall 272 and within the stomach cavity
(SC) such that its proximal end 282 is placed within the stomach
cavity (SC) at the stoma (ST) and its distal end 283 extends past
the pylorus (PY) and partly into the duodenum. Although fluid
conduit 281 may be sized to have a length that is shorter than the
conduit wall 272, it may typically be sized to have a length which
is longer than or coterminus with that of conduit wall 272, and
further adapted to facilitate fluid communication between the
stomach cavity (SC), or gastric remnant, and the intestines, or the
duodenal ampulla 323 and the intestines. As positioned, fluid
conduit 281 allows for the gastric fluids produced within the
stomach cavity (SC) and the digestive fluids discharged through the
duodenal ampulla (or duct) 323 to intermix and to be transported
through the conduit 281 between the stomach cavity (SC) and the
intestine distal of the duodenal ampulla 323. The fluid conduit 281
also allows for the fluids to intermix and for the fluids produced
within the stomach cavity (SC) to drain without contacting any
ingested foods transported through the bypass conduit 272. If the
distal end 283 of the fluid conduit 281 extends past the duodenal
ampulla 323, the region of the conduit 281 near or at the entrance
to the duct 323 may define one or more fenestrations or openings
324 along its length. These fenestrations 324 may be positioned and
sized appropriately such that they allow for the fluid
communication between the duct 323 and the lumen of the fluid
conduit 281.
[0081] FIG. 17A shows another variation 330 utilizing the lap band
321 with the coaxial fluid bypass conduit 290. FIG. 17B shows a
view of the stomach prior to having the conduit assembly 290
deployed. In this variation, fluid conduit 291 may be positioned
such that its proximal end is within the stomach cavity (SC) and
its distal end 294 is positioned within the duodenum 322 to the
jejunum, either proximally of or at the duodenal ampulla 323. If
the distal end 294 is positioned distally of the ampulla 323, one
or more fenestrations 331 may be defined along the length of the
fluid conduit 291 to facilitate the fluid exchange and to maintain
the fluid communication, as described above, between the ampulla
323 and local intestine and the fluid conduit 291. The use of this
coaxially adjacent conduit variation allows for the free rotation
of the conduit wall 272 and/or fluid conduit 291 about its
longitudinal axis within the stomach cavity (SC) without the
problems of kinking or improper placement of the fluid conduit
relative to the stomach cavity (SC). The proximal 271 and distal
273 ends of the conduit wall 272 may be anchored in much the same
manner as described above.
[0082] In the case of a stomach which has undergone a vertical
banded gastroplasty (VBG) procedure, the conduit may also be
utilized to facilitate patient treatment. FIG. 18B shows a view of
the stomach which has had the VBG procedure prior to deployment of
the bypass conduit. As shown, a vertical staple line 341 has been
deployed along a portion of the stomach extending from the circular
defect 342 defined within the stomach to the gastroesophageal
junction (GEJ). A silastic band 343 has also been positioned to
create a narrowing or stoma at the end of the staple line 341. As
shown in the variation 340 of FIG. 18A, the bypass conduit 272 may
be deployed such that its proximal end 271 is secured within the
stoma (ST) created by placement of the silastic band 343 to bypass
the stomach cavity (SC) and extend distally through the pylorus
(PY), as described above. The conduit may thus extend from within
the stomach cavity (SC) to within the intestinal tract. Moreover,
one or more fenestrations 331 may be defined along certain portions
of the length of the conduit wall 272 positioned at active
secretory zones (such as within the stomach cavity (SC) and/or the
duodenal ampulla) to allow fluid exchange through the walls of the
bypass conduit 272 at the point of those anatomic structures. By
spacing fenestrations 331, and limiting them to communication with
only specified active zones, a single conduit construction can
function both as a sufficient barrier between ingested food and the
intestine (malabsorption), and a selected flowpath for digestive
fluids.
[0083] FIG. 19A shows another variation 350 in which a bypass
conduit may be used a stomach which has undergone laparoscopic
banding to constrict the stomach cavity (SC) and create a stoma.
The lap band 343 may be used to constrict the stomach such that the
original stomach, as indicated by the outline 351, is constricted
by the band 343 to create a constricted stomach, as indicated by
the constricted outline 352. The bypass conduit proximal end 271
may then be secured within the stoma created by the lap band 343,
as described above. Furthermore, fenestrations 331, which may be
valved, may be placed along the length of the bypass conduit 272 to
allow a single conduit to perform the dual functions of
malabsorption and the maintenance of digestive fluid flow. Such
fenestrations may include one-way valves that open to receive
fluids from outside the bypass conduit. The valves may be
configured to selectively open at regions along the conduit length
where the pressure from such flow overcomes the force which
maintains the valve closed; adequate pressure from the flow may be
generated by the fluids such as within the gastric remnant or at
the inflow of the ducts (duodenal ampulla). Such a design would not
require specific alignment at flow inlets. FIG. 19C depicts one
variation of a one-way valve 354 having a door or flap 355 hinged
or partially secured at 356 to the inside of bypass conduit wall
272. Flap 355 may be biased to urge the valve shut in the absence
of the fluid flow. FIGS. 19D and 19E are illustrative examples
which show variations on the flap 355. FIG. 19D shows a flap 355'
which may be attached to the conduit wall and hinged via notched
section 356' about which flap 355' may rotate. FIG. 19E shows
another example in which flap 355'' may be attached about a biased
hinge 356''. In either case, these examples are merely intended to
be illustrative and other methods of flap actuation are intended to
be included herein. In addition, such selective communication
between bypass conduit 272 and related organs or intestine can be
established by varying the porosity or permeability of certain
segments 357, 358 along the length of bypass conduit wall 272, as
shown in FIG. 19F. FIG. 19B shows a cross-sectional view of the
bypass conduit wall 272 secured to the stomach wall 353 by the lap
band 343.
[0084] Another variation on conduit placement may be seen in
conjunction with an intragastric stapling procedure in the
variation 360 in FIG. 20A. FIG. 20B shows a view of the stomach in
which an intragastric stapling procedure has been performed to
create an intragastric staple line 361. To affix a bypass conduit
362 near or at the end of the staple line 361, conduit 362 may
utilize an anchor region 363, or stoma, which may use any of the
various anchoring methods described above. For instance, any number
of fasteners, e.g., hooks, barbs, clamps, sutures, staples, stents,
bands, adhesives, etc., may be used although FIG. 20A shows an
anchor configured as a stent. The anchor region 363 may be placed
anywhere along the staple line 361 so long as the anchor region 363
may be securely affixed between the staple line 361 and the stomach
tissue. The distal end 364 of the conduit 362 may remain unanchored
or it may be optionally anchored to the tissue within the duodenum
322, as described above.
[0085] Yet another variation on conduit placement may be seen in
the variation 370 in FIG. 21A. FIG. 21B shows a view of the stomach
that has undergone a horizontal gastroplasty procedure in which a
horizontal staple line 371 is created extending from the lesser
curvature (LC) to the greater curvature (GC) of the stomach. A
portion of the stomach may be left unstapled to create a stoma 372
between the esophagus and the remainder of the stomach cavity (SC).
The proximal end 271 of the bypass conduit 272 may be secured
within this stoma 372 using any of the attachment methods as
described above.
[0086] Another variation may be seen in variation 380 in FIG. 22A.
In this variation, the stomach has undergone a biliopancreatic
diversion (BPD) procedure where a small portion of the stomach is
partitioned off and the remaining portion of the stomach may be
left or removed. A BPD procedure is similar to a Jejuno-Ileal
Bypass (JIB) procedure in which a large portion, i.e., about
two-thirds, of the stomach is partitioned off and/or removed. FIG.
22B shows a view of a stomach which has been partitioned along a
staple line 381, which may roughly parallel the lesser curvature
(LC) of the stomach extending from the gastroesophageal junction
(GEJ) to near the pylorus (PY). The partitioned-off portion 382 may
optionally be removed leaving the portion of the stomach extending
from the esophagus (ES) directly to the pylorus (PY). Within the
remaining portion of stomach, the bypass conduit 272 may be
positioned such that its proximal end 271 is secured near or at the
gastroesophageal junction (GEJ), using any of the methods described
above, and the distal end 273 may be routed distal of the stomach
into the intestinal tract where it may be unanchored or secured to
the tissue.
[0087] Yet another variation on conduit placement may include the
use of conventional devices such as those described in U.S. Pat.
No. 4,458,681 (Hopkins) and in U.S. Pat. No. 4,558,699 (Bashour),
which are both incorporated herein by reference in their entirety.
Both patents describe variations on clamps which may be placed
across a stomach (externally) to create a stoma therewithin for the
passage of food through the stomach. The clamps may be placed over
the stomach, e.g., through conventional laparoscopic procedures,
and a bypass conduit may be placed endoscopically within the
stomach such that the proximal end of the conduit is supported by
the clamp within the created stoma using any of the methods
described above.
[0088] The steps of performing the method of organ division or
reduction (transoral stomach reduction) are used to illustrate in
detail the method and devices of the present invention, however the
present invention is not limited thereby. Use of these steps and
the tools deployed therein may be varied to achieve a similar
result in other hollow body organs and it is anticipated that such
techniques can be employed to divide or restrict other hollow body
organs such as organs of the gastrointestinal tract such as bowel,
stomach or intestine, or in procedures in the bladder (treatment
for incontinence by reinforcing the bladder sphincter) or uterus,
etc. In addition, as previously mentioned, other procedures such as
the treatment of GERD may also benefit from the methods and devices
disclosed herein. While certain embodiments have been illustrated
and described in detail, those having ordinary skill in the art
will appreciate that various alternatives, modifications, and
equivalents may be used and that the invention is not intended to
be limited to the specifics of these variations.
* * * * *
References