U.S. patent application number 10/686427 was filed with the patent office on 2005-04-14 for transesophageal gastric reduction device, system and method.
Invention is credited to Adams, John M., Kraemer, Stefan J.M..
Application Number | 20050080444 10/686427 |
Document ID | / |
Family ID | 34423290 |
Filed Date | 2005-04-14 |
United States Patent
Application |
20050080444 |
Kind Code |
A1 |
Kraemer, Stefan J.M. ; et
al. |
April 14, 2005 |
Transesophageal gastric reduction device, system and method
Abstract
A gastric reduction system and method provides for
transesophageal formation of a gastric reduction pouch of the
stomach. The system includes an expandable structure which may be
placed in a stomach and expanded to occupy a fractional volume of
the stomach. An evacuator is then fed through the expandable
structure and utilized to deflate the stomach and draw the stomach
to and around the expandable structure to form the gastric
reduction pouch. A self-deploying fastener is then deployed to
maintain the gastric reduction pouch.
Inventors: |
Kraemer, Stefan J.M.;
(Seattle, WA) ; Adams, John M.; (Sammamish,
WA) |
Correspondence
Address: |
Richard O. Gray, Jr.
GRAYBEAL JACKSON HALEY LLP
Suite 350
155 - 108th Avenue NE
Bellevue
WA
98004-5973
US
|
Family ID: |
34423290 |
Appl. No.: |
10/686427 |
Filed: |
October 14, 2003 |
Current U.S.
Class: |
606/192 ;
606/155; 623/23.65 |
Current CPC
Class: |
A61F 5/0086 20130101;
A61B 2017/00818 20130101; A61B 2017/308 20130101; A61B 17/122
20130101; A61B 17/1285 20130101; A61F 2/91 20130101 |
Class at
Publication: |
606/192 ;
606/155; 623/023.65 |
International
Class: |
A61F 002/04 |
Claims
What is claimed:
1. A gastric reduction device comprising: an expandable structure,
placeable in a stomach, the expandable structure, when expanded,
occupying a portion of the stomach; and an evacuator that deflates
the stomach around the expandable structure to form a gastric
reduction pouch.
2. The device of claim 1 wherein the expandable structure is
placeable in the stomach immediately adjacent and distal to an
esophageal orifice associated with the stomach.
3. The device of claim 1 wherein the expandable structure comprises
a balloon.
4. The device of claim 1 wherein the expandable structure is an
inflatable structure.
5. The device of claim 4 wherein the inflatable structure is a
compliant balloon.
6. The device of claim 4 wherein the inflatable structure is a
non-compliant balloon.
7. The device of claim 1 wherein the evacuator extends distally
from the expandable member and terminates within the stomach.
8. The device of claim 1 further comprising a fastener that
maintains the gastric reduction pouch.
9. The device of claim 8 wherein the fastener inwardly folds
stomach tissue to fasten serosa tissue to serosa tissue of the
stomach.
10. The device of claim 8 wherein the fastener comprises a
cylindrically shaped member having opposed ends and tissue engaging
arms radially extending from each of the opposed ends.
11. The device of claim 1 further comprising an endoscope that
extends through the expandable member.
12. The device of claim 1 wherein the expandable member forms a
spherically shaped ring when expanded.
13. The device of claim 12 wherein the spherically shaped ring
includes an axial passageway and wherein the evacuator extends
through the passageway.
14. A gastric reduction system, comprising: an expandable
structure, placeable in a stomach and, when expanded, occupying a
fractional volume of the stomach; an evacuator that deflates the
stomach and draws the stomach to and around the expandable
structure to form a gastric reduction pouch with stomach tissue;
and a fastener that is operable to maintain the gastric reduction
pouch.
15. The system of claim 14 wherein the expandable structure is
placeable in the stomach immediately adjacent and distal to an
esophageal orifice associated with the stomach.
16. The system of claim 14 wherein the expandable structure
comprises a balloon.
17. The device of claim 14 wherein the expandable structure is an
inflatable structure.
18. The device of claim 17 wherein the inflatable structure is a
compliant balloon.
19. The device of claim 17 wherein the inflatable structure is a
non-compliant balloon.
20. The system of claim 14 wherein the evacuator extends distally
from the expandable member and terminates within the stomach.
21. The system of claim 14 wherein the fastener inwardly folds
stomach tissue to fasten serosa tissue to serosa tissue of the
stomach.
22. The system of claim 21 wherein the fastener comprises a
cylindrically shaped member having opposed ends and tissue engaging
arms radially extending from each of the opposed ends.
23. The system of claim 21 wherein the fastener is carried by the
evacuator.
24. The system of claim 14 further comprising an endoscope that
extends through the expandable member.
25. The system of claim 14 wherein the expandable member forms a
spherically shaped ring when expanded.
26. The system of claim 25 wherein the spherically shaped ring
includes an axial passageway and wherein the evacuator extends
through the passageway.
27. A method comprising: positioning an expandable structure in a
stomach of a patient; expanding the expandable structure to occupy
a portion of the stomach; and drawing the stomach around the
expanded expandable structure to form a gastric reduction
pouch.
28. The method of claim 27 wherein the positioning step includes
placing the expandable structure immediately distal to an
esophageal orifice associated with the stomach.
29. The method of claim 27 wherein the expandable structure
comprises a balloon and wherein the expanding step includes
inflating the balloon.
30. The method of claim 27 wherein the deflating step includes
evacuating the stomach.
31. The method of claim 27 wherein the deflating step includes
feeding an evacuator into the stomach and evacuating the
stomach.
32. The method of claim 27 including the further step of
maintaining the gastric reduction pouch.
33. The method of claim 32 wherein the maintaining step includes
inwardly folding stomach tissue to contact serosa tissue to serosa
tissue to form a stomach.
34. The method of claim 33 wherein the maintaining step further
includes fastening the inwardly folded stomach tissue together.
Description
FIELD OF THE INVENTION
[0001] The present invention is generally directed to a therapy for
treating obesity. The present invention is more particularly
directed to a transesophageal gastric reduction device, system, and
method for performing gastric reduction surgery while minimizing
surgical invasion.
BACKGROUND OF THE INVENTION
[0002] Obesity is a complex chronic disease involving environment,
genetic, physiologic, metabolic, behavioral and psychological
components. It is the second leading cause of preventable death in
the United States.
[0003] Obesity affects nearly one-third of the adult American
population (approximately 60 million). The number of overweight and
obese Americans has continued to increase since 1960. The trend is
not slowing down. Today, 64.5% of adult Americans are categorized
as being overweight or obese. Each year, obesity causes at least
300,000 excess deaths in the United States, and healthcare costs of
American adults with obesity amounted to approximately
$100,000,000,000 (100 billion dollars).
[0004] Obesity is not limited to the United States but is
increasing worldwide. It is increasing worldwide in both developing
and developed countries and is thought to be caused by
environmental and behavioral changes resulting from economic
development, modernization, and urbanization. Obesity is increasing
in children as well. It is believed that the true health
consequences of obesity have not yet become totally apparent.
[0005] Obesity is currently treated by dietary therapy, physical
activity, behavioral therapy, drug therapy, and combinations
thereof. Dietary therapy involves instruction on how to adjust a
diet to reduce the number of calories eaten. Physical activity
strategies include use of aerobic exercise, brisk walking, jogging,
cycling, and swimming. Behavioral therapy involves changing diet
and physical activity patterns and habits to new behaviors that
promote weight loss. Drug therapy is most often used only in
conjunction with appropriate lifestyle modifications.
[0006] One last treatment for obesity is surgery. Surgery is a
treatment option which is generally reserved for persons with
severe obesity and those who are morbidly obese. In addition,
surgery is not generally performed until other methods of weight
loss have been attempted and have been found to be ineffective.
Persons who are severely obese are generally unable to physically
perform routine daily activities, whether work-related or family
functions and have a severely impaired quality of life due to the
severity of their obesity.
[0007] Most obesity surgeries involve making changes to the stomach
and/or small intestines. Currently, there are two types of obesity
surgery: (1) restrictive; and (2) combined restrictive and
malabsorptive. Operative procedures have been developed for each
type of surgery. Each type of surgery has its own risks and side
effects.
[0008] In restrictive surgery, bands or staples are used to create
food intake restriction. The bands or staples are surgically placed
near the top of the stomach to section off a portion that is often
called a stomach pouch. A small outlet, about the size of a pencil
eraser, is left at the bottom of the stomach pouch. Since the
outlet is small, food stays in the pouch longer and the feeling of
fullness lasts for a longer time. Current operative procedures for
restrictive surgery include vertical banded gastroplasty, gastric
banding, and laparoscopic gastric banding. In vertical banded
gastroplasty, a stomach pouch is surgically created. In gastric
banding, a band is used to create the stomach pouch. In
laparoscopic gastric banding, a less invasive procedure, smaller
incisions are made to apply the band. The band is inflatable and
may be adjusted over time.
[0009] Each of the foregoing therapies for severe obesity has its
risks and side effects. Each is invasive surgery and hence exhibits
the risks commonly associated with all surgical procedures.
Complications may include leaking of stomach juices into the
abdomen, injury to the spleen, band slippage, erosion of the band,
breakdown of the staple line, and stomach pouch stretching from
overeating.
[0010] However, reductive surgery has proven successful. About 80%
of patients lose some weight and 30% reach a normal weight. Hence,
the benefits of gastric reduction surgery are generally believed to
outweigh the attendant risks and potential complications.
[0011] The present invention is directed to an alternative device,
system, and method for achieving gastric reduction. As will be seen
hereinafter, the device, system, and method do not require surgical
incisions and is thus less invasive than previous reduction
therapies.
SUMMARY OF THE INVENTION
[0012] The invention generally provides a gastric reduction device
comprising an expandable structure placeable in a stomach which,
when expanded, occupies a portion of the stomach and an evacuator
that deflates the stomach around the expandable structure to form a
gastric reduction pouch. The expandable structure is preferably
placeable in the stomach immediately adjacent and distal to an
esophageal orifice associated with the stomach.
[0013] The expandable structure may comprise a balloon. The
evacuator may extend distally from the expandable member and
terminate within the stomach.
[0014] The device may further comprise a fastener that maintains
the gastric reduction pouch. The fastener is preferably arranged to
inwardly fold stomach tissue to fasten serosa tissue to serosa
tissue of the stomach. The fastener may comprise a cylindrically
shaped member having opposed ends and tissue engaging arms radially
extending from each of the opposed ends.
[0015] The device may further comprise an endoscope that extends
through the expandable member. The expandable member preferably
forms a spherically shaped ring when expanded. The spherically
shaped ring may include an axial passageway permitting the
evacuator to extend through the passageway.
[0016] The present invention still further provides a gastric
reduction system comprising an expandable structure, placeable in a
stomach, and, when expanded, occupying a fractional volume of the
stomach. The system further includes an evacuator that deflates the
stomach and draws the stomach to and around the expandable member
to form a gastric reduction pouch with stomach tissue and a
fastener that is operable to maintain the gastric reduction pouch.
The fastener may be carried by the evacuator.
[0017] The present invention still further provides a method
comprising the steps of positioning an expandable structure in a
stomach of a patient, expanding the expandable structure to occupy
a portion of the stomach, and drawing the stomach around the
expandable structure to form a gastric reduction pouch. The
positioning step may include placing the expandable structure
immediately distal to an esophageal orifice associated with the
stomach. The expandable structure may comprise a balloon and the
expanding step may include inflating the balloon.
[0018] The deflating step may include evacuating the stomach. To
this end, an evacuator may be fed into the stomach. The evacuator
may be fed into the stomach through the expandable structure.
[0019] The method may further include the step of maintaining the
gastric reduction pouch. Maintaining the gastric reduction pouch
may include inwardly folding stomach tissue to contact serosa
tissue to serosa tissue to form a stoma. The inwardly folded
stomach tissue may be fastened together.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The features of the present invention which are believed to
be novel are set forth with particularity in the appended claims.
The invention, together with further features and advantages
thereof, may best be understood by making reference to the
following description taken in conjunction with the accompanying
drawings, in the several figures of which like reference numerals
identify identical elements, and wherein:
[0021] FIG. 1 is a front cross-sectional view of the
esophageal-gastro-intestinal tract from a lower portion of the
esophagus to the duodenum;
[0022] FIG. 2 is a perspective view with portions cut away of a
device embodying the present invention;
[0023] FIG. 3 is a perspective view with portions cut away of the
device of FIG. 2 illustrating partial deployment of a fastener in
accordance with the present invention;
[0024] FIG. 4 is a perspective view with portions cut away of the
device of FIG. 2 with the fastener in a further stage of
deployment;
[0025] FIG. 5 is a cross-sectional view of an esophagus and stomach
with a device embodying the present invention in an initial stage
of gastric reduction therapy in accordance with the present
invention;
[0026] FIG. 6 is a cross-sectional view similar to FIG. 5 of the
device in a further stage of the therapy;
[0027] FIG. 7 is a cross-sectional view similar to FIG. 5 of the
device delivering a fastener in a still further stage of the
therapy;
[0028] FIG. 8 is a cross-sectional view similar to FIG. 5 of the
device and fastener in a final stage of the therapy; and
[0029] FIG. 9 is a cross-sectional view similar to FIG. 5 after
completion of the therapy and removal of the device embodying the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0030] FIG. 1 is a front cross-sectional view of the
esophageal-gastro-intestinal tract 40 from a lower portion of the
esophagus 41 to the duodenum 42. The stomach 43 is characterized by
the greater curvature 44 on the anatomical left side and the lesser
curvature 45 on the anatomical right side. The tissue of the outer
surfaces of those curvatures is referred to in the art as serosa
tissue. As will be seen subsequently, the nature of the serosa
tissue is used to advantage for its ability to bond to like serosa
tissue. The fundus 46 of the greater curvature 44 forms the
superior portion of the stomach 43, and traps gas and air bubbles
for burping. The esophageal tract 41 enters the stomach 43 at an
esophageal orifice 58 below the superior portion of the fundus 46,
forming a cardiac notch 47 and an acute angle with respect to the
fundus 46 known as the Angle of His 57. The lower esophageal
sphincter (LES) 48 is a discriminating sphincter able to
distinguish between burping gas, liquids, and solids, and works in
conjunction with the fundus 46 to burp. The gastroesophageal flap
valve (GEFV) 49 includes a moveable portion and an opposing more
stationary portion. The moveable portion of the GEFV 49 is an
approximately 180 degree, semicircular, gastroesophageal flap 50
(alternatively referred to as a "normal moveable flap" or "moveable
flap") formed of tissue at the intersection between the esophagus
41 and the stomach 43. The opposing more stationary portion of the
GEFV 49 comprises a portion of the lesser curvature 45 of the
stomach 43 adjacent to its junction with the esophagus 41. The
gastroesophageal flap 50 of the GEFV 49 principally comprises
tissue adjacent to the fundus 46 portion of the stomach 43, is
about 4 to 5 cm long (51) at it longest portion, and the length may
taper at its anterior and posterior ends. The gastroesophageal flap
50 is partially held against the lesser curvature 45 portion of the
stomach 43 by the pressure differential between the stomach 43 and
the thorax, and partially by the resiliency and the anatomical
structure of the GEFV 49, thus providing the valving function. The
GEFV 49 is similar to a flutter valve, with the gastroesophageal
flap 50 being flexible and closeable against the other more
stationary side.
[0031] The esophageal tract is controlled by an upper esophageal
sphincter (UES) near the mouth for swallowing, and by the LES 48
and the GEFV 49 at the stomach. The normal anti-reflux barrier is
primarily formed by the LES 48 and the GEFV 49 acting in concert to
allow food and liquid to enter the stomach, and to considerably
resist reflux of stomach contents into the esophagus 48 past the
gastroesophageal tissue junction 52. Tissue aboral of the
gastroesophageal tissue junction 52 is generally considered part of
the stomach because the tissue protected from stomach acid by its
own protective mechanisms. Tissue oral of the gastroesophageal
junction 52 is generally considered part of the esophagus and it is
not protected from injury by prolonged exposure to stomach acid. At
the gastroesophageal junction 52, the juncture of the stomach and
esophageal tissues form a zigzag line, which is sometimes referred
to as the "Z-line." For the purposes of these specifications,
including the claims, "stomach" means the tissue aboral of the
gastroesophageal junction 52.
[0032] FIG. 2 shows a device 60 embodying the present invention. As
will be seen hereinafter, the device 60 permits transesophageal
gastric reduction for treating severe obesity. The device 60
generally includes an expandable structure 70 and an evacuator 80.
Shown further in FIG. 2 is a fastener 90 which the device 60
delivers to maintain a formed gastric reduction pouch.
[0033] The expandable structure 70, in accordance with this
embodiment, takes the form of an inflatable ring-shaped balloon 72
which is integrally formed on and carried by an outer catheter 74.
The ring-shaped balloon 72 and catheter 74 define an axial
passageway 76. The balloon may be a compliant balloon formed of
latex or polyurethane, for example. It may alternatively be a
non-compliant balloon formed of polyethylene. A non-compliant
balloon may be preferred as it maintains a fixed shape and size
once totally inflated rendering the size of the balloon is rendered
predictable.
[0034] The evacuator 80, in accordance with this embodiment,
comprises an endoscope 82 which includes a light source 84, a
viewer 86, and a working channel 88. Endoscopes of this type are
well known in the art. The working channel 88 is employed for
evacuating the stomach once the device 60 is in place within the
stomach and the balloon 72 has been inflated. This will become more
apparent subsequently.
[0035] As will be noted in FIG. 2, the evacuator 80 extends through
the expandable structure 70. More specifically, the endoscope 82
may be advanced through the axial passageway 76 to terminate distal
to the expandable structure 70 to facilitate the evacuation of the
stomach. The fastener 90 may be carried by the endoscope 82 and
also advanced through the axial passageway 76 along the endoscope
82 by a tubular pusher 100.
[0036] The fastener 90 is preferably formed of a shape memory
material such as Nitinol or a shape memory plastic, for example, so
as to be self-deploying when advanced past the distal end 78 of the
catheter 74. It alternatively may be formed of stainless steel but
would then require forced expansion as, for example, a balloon as
is well known in the art. FIG. 3 illustrates the fastener 90 during
an initial stage of its deployment. The fastener 90 prior to its
deployment takes the form of a cylindrically shaped member 92
having opposed ends from which first and second sets of tissue
engaging arms radially extend after deployment. As will be noted in
FIG. 3, a first set of tissue engaging arms 93 are radially
extending from the cylindrical member 92 as the fastener 90 is
advanced by the catheter 100 past the distal end 78 of the catheter
74. Upon further displacement of the fastener 90 as illustrated in
FIG. 4, the cylindrical center portion of the cylindrical member 92
is exposed. This forms a channel through which ingested food may
pass out of the gastric reduction pouch after it is formed and
maintained by the fastener 90.
[0037] Referring now to FIG. 5, it illustrates an initial stage of
forming the gastric reduction pouch in accordance with the present
invention. Here it will be seen that the expandable structure 70
has been advanced through the esophagus 41 on the catheter 74 so
that it is placed in the stomach immediately adjacent and distal to
the esophageal orifice 58. After the expandable member is
positioned adjacent the esophageal orifice 58, the endoscope 82 is
advanced through the axial passageway of the catheter 74 and
expandable structure 70 until it is distal to the catheter 74 and
expandable structure 70 within the stomach 43.
[0038] After the expandable structure 70 and endoscope 82 are
placed in the stomach 43 as illustrated in FIG. 5, the expandable
structure 70 is expanded to define the size and shape of the
gastric reduction pouch to be formed. In accordance with this
preferred embodiment, the expandable structure 70 comprises a
balloon 72 which may be inflated as illustrated in FIG. 6. Here it
may be seen that the balloon 72 has been inflated and occupies a
fraction or portion of the stomach 43. The balloon 72 may be
inflated through a lumen (not shown) in the catheter 74 in a manner
well known in the art.
[0039] After the balloon 72 has been expanded to its desired size,
the stomach 43 is evacuated through the working channel of the
endoscope 82 to cause the stomach to be drawn around the balloon
72.
[0040] Once the stomach tissue has been drawn around the balloon
72, the fastener 90 is then advanced down the endoscope 82 by the
pusher 100 for deploying the fastener 90. As shown in FIG. 7, the
fastener 90 is partially deployed with the first set of tissue
engaging arms 93 radially extending from the cylindrical body 92 of
the fastener 90. Upon further advancement of the fastener 90 as
illustrated in FIG. 8, the second set of tissue engaging arms 95
are released from the catheter 74 to radially extend from the
cylindrical body 92 of the fastener 90.
[0041] The shape memory of the fastener 90 may be used to advantage
by which the opposed sets of radially extending tissue engaging
arms 93 and 95 together with the drawing of the stomach around the
balloon 72 inwardly folds the outer surfaces of the stomach 43 to
cause contact between adjacent outer surfaces of the stomach about
the cylindrical body 92 of the fastener 90. The outer surface of
the stomach comprises serosa tissue which develops a bond after
contacting like tissue within a short period of time. This bond
between the outer surfaces of the contacting stomach tissue will
assist the fastener 90 in maintaining the gastric reduction pouch
thus formed.
[0042] Once the fastener 90 has been fully deployed as illustrated
in FIG. 8, the assembly and device 60 is removed from the stomach.
This may be achieved by first drawing the pusher 100 out of the
catheter 74. Then, the balloon 72 may be deflated permitting the
balloon 72 and catheter 74 to be withdrawn from the stomach on the
endoscope 82. Lastly, the endoscope 82 may be withdrawn through the
fastener 90, through the gastric reduction pouch formed by the
assembly and device 60, and the esophagus 41. This leaves the
esophageal-gastro-intestinal tract 40 in a condition as illustrated
in FIG. 9. Here it may be seen that the gastric reduction pouch 110
has been formed between the esophagus 41 and the remaining stomach
43. The fastener 90 may remain in place to maintain the gastric
reduction pouch 110. The gastric reduction pouch 110 presents a
smaller volume to accommodate ingested food thus providing the
patient with an earlier sense of being full and a longer time of
feeling full.
[0043] As will be noted from the foregoing, the process of forming
the gastric reduction pouch 110 with the device 60 embodying the
present invention has been performed in a transesophageal manner
without the need of any surgical incisions. Hence, the therapy
contemplated herein is much less invasive than previous therapies
for providing gastric reduction therapy. All of the advantages of
gastric reduction therapy are available while substantially
reducing the risks attendant to general surgery.
[0044] While particular embodiments of the present invention have
been shown and described, modifications may be made, and it is
therefore intended in the appended claims to cover all such changes
and modifications which fall within the true spirit and scope of
the invention.
* * * * *