U.S. patent application number 13/277374 was filed with the patent office on 2012-04-26 for endoscopic implantable device and method for the apposition of the stomach walls for reducing the stomach internal volume in a weight loss surgery procedure.
Invention is credited to ROBERTO FOGEL.
Application Number | 20120101594 13/277374 |
Document ID | / |
Family ID | 45973631 |
Filed Date | 2012-04-26 |
United States Patent
Application |
20120101594 |
Kind Code |
A1 |
FOGEL; ROBERTO |
April 26, 2012 |
ENDOSCOPIC IMPLANTABLE DEVICE AND METHOD FOR THE APPOSITION OF THE
STOMACH WALLS FOR REDUCING THE STOMACH INTERNAL VOLUME IN A WEIGHT
LOSS SURGERY PROCEDURE
Abstract
The present invention is referred to an endoscopic implantable
device for the apposition of the stomach walls for reducing the
stomach internal volume, comprising a cylindrical elongated body
comprising two hinged halves, each of which having a plurality of
suction nozzles and a set of aligned grabbing teeth. Said suction
nozzles have a fluid communication with a suction port of the
endoscopic apparatus used to place said device into the patient's
stomach, and the mentioned teeth of each half cooperate between
each other to grab and keep the walls of the stomach together until
the device is dissolved by the gastric fluids present in the
stomach. The purposed invention also comprises a method for joining
internal body tissue.
Inventors: |
FOGEL; ROBERTO; (Sunny Isles
Beach, FL) |
Family ID: |
45973631 |
Appl. No.: |
13/277374 |
Filed: |
October 20, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61405667 |
Oct 22, 2010 |
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Current U.S.
Class: |
623/23.64 |
Current CPC
Class: |
A61F 5/0086
20130101 |
Class at
Publication: |
623/23.64 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Claims
1. Endoscopic implantable device for the apposition of the stomach
walls for reducing the stomach internal volume, comprising an
elongated endoscopic tube at the distal end of which an apposition
means is attached, and at the external end means for managing said
apposition means are included; said endoscopic tube also includes a
vacuum channel connectable to a pump capable of creating a vacuum
effect on the distal end, and said apposition means comprising a
body releasably attached to the distal end of said flexible tube,
including two hinged halves, each halve with a double wall that
creates an internal chamber in fluid communication with the vacuum
channel of the elongated tube; the internal side of each halve has
a plurality of suction nozzles in fluid communication with said
chamber, and a set of grabbing teeth.
2. The endoscopic implantable device of claim 1, wherein said body
has a cylindrical elongated shape.
3. The endoscopic implantable device of claim 1, wherein said set
of grabbing teeth projects from the outer edge of each halve of the
body.
4. The endoscopic implantable device of claim 3, wherein said teeth
are separated between each other, defining a small space.
5. The endoscopic implantable device of claim 4, wherein said space
is occupied by the teeth of the other halve when the device is in
its closed position.
6. The endoscopic implantable device of claim 3, wherein each tooth
is sharpened to allow the teeth to punch the walls of the
stomach.
7. The endoscopic implantable device of claim 1, wherein a suction
effect on each nozzle is created when the suction port of the
endoscopic device is connected to an external pump.
8. The endoscopic implantable device of claim 1, wherein the
elongated tube includes securing means with which the endoscopic
device may be attached and detached from the elongated tube.
9. The endoscopic implantable device of claim 7, wherein the
securing means includes a fluid communication channel to
communicate the internal chamber with the suction port of the
elongated tube.
10. The endoscopic implantable device of claim 1, wherein the
elongated tube includes a mechanical means to open and close said
halves.
11. The endoscopic implantable device of claim 1, wherein the whole
endoscopic implantable device is made of biodegradable
material.
12. The endoscopic implantable device of claim 1, wherein the whole
endoscopic implantable device is made of different sizes.
13. The endoscopic implantable device of claim 1, wherein the whole
endoscopic implantable device is made of plastic material.
14. Method for the apposition of the stomach walls endoscopically
comprising: a) navigating a distal end of an endoscopic apposition
device to a treatment site, the apposition device having a body
with two hinged halves, each halve with a double wall that creates
an internal chamber in fluid communication with a suction port of
the elongated tube; the internal side of each halve has a plurality
of suction nozzles in fluid communication with said chamber, and a
set of grabbing teeth disposed on the outer edge of the device, and
a hold and release mechanism; b) advancing the device inside the
stomach; c) opening said halves exposing the suction nozzles to the
inner walls of the stomach, d) putting fluid communication in said
nozzles with the vacuum means of the elongated tube; e) applying
vacuum to the internal chamber until the wall of the stomach is
attached to the inner walls of said halves; f) closing the device
by punching the teeth to the stomach tissue, and securing the
portion of tissue together; g) detaching the endoscopic apposition
device from the elongated tube; and h) taking the device out of the
patient's body.
15. Method for the apposition of the stomach walls endoscopically
of claim 14, wherein the whole endoscopic implantable device is
made of biodegradable material.
16. Method for joining internal body tissue endoscopically,
comprising: a) navigating a distal end of an endoscopic apposition
device to a treatment site, the apposition device having a body
with two hinged halves, having each halve a double wall that
creates an internal chamber in fluid communication with a suction
port of the elongated tube; the internal side of each halve has a
plurality of suction nozzles in fluid communication with said
chamber, and a set of grabbing teeth disposed on the outer edge of
the device, and a hold and release mechanism; b) advancing the
device inside the body of the patient endoscopically; c) opening
said halves exposing the suction nozzles to the inner walls of the
tissue to be joined, d) putting fluid communication in said nozzles
with the vacuum means of the elongated tube; e) applying vacuum to
the internal chamber until the tissue to be joined is attached to
the inner walls of said halves; f) closing the device by punching
the teeth to the tissue, and securing the portion of tissue
together; g) detaching the endoscopic apposition device from the
elongated tube; and h) taking the device out of the patient's
body.
17. Method for joining internal body tissue endoscopically of claim
16, wherein the tissue to be joined is a fistula.
18. Method for joining internal body tissue endoscopically of claim
16, wherein the tissue to be joined is a perforated portion of a
stomach.
19. Method for joining internal body tissue endoscopically of claim
16, wherein the whole endoscopic implantable device is made of
biodegradable material.
20. Method for joining internal body tissue endoscopically of claim
16, wherein the whole endoscopic implantable device is made of
different sizes.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] This invention relates generally to an endoscopic
implantable device and method capable of delivering, during a
weight loss surgery procedure, a functional device through the
patient's esophagus and to the stomach where it is attached to the
stomach walls. More particularly, the present invention is referred
to an endoscopic implantable device for the apposition of the
stomach walls by delivering the device to the stomach, opening it
up, creating a suction effect for attracting the stomach walls,
closing it and leaving the device into the stomach reducing the
internal volume of the stomach. Even more particularly, the present
invention is referred to a method for the apposition of different
types of tissue, including but not limited to, the stomach walls,
fistulas, hemorrhages, etc.
[0003] 2. Description of the Prior Art
[0004] Obesity is a medical condition in which excess body fat has
accumulated to the extent that it may have an adverse effect on
health, leading to reduced life expectancy. Body mass index (BMI),
which compares weight and height, is used to define a person as
overweight when their BMI is between 25 kg/m.sup.2 and 30
kg/m.sup.2 and obese when it is greater than 30 kg/m.sup.2.
[0005] Obesity is associated with many diseases, particularly heart
disease, type 2 diabetes, breathing difficulties during sleep,
certain types of cancer, and osteoarthritis. Obesity is most
commonly caused by a combination of excessive dietary calories,
lack of physical activity, and genetic susceptibility, though a
limited number of cases are due solely to genetics, medical reasons
or psychiatric illness.
[0006] Obesity is a leading preventable cause of death worldwide,
with increasing prevalence in adults and children, and authorities
view it as one of the most serious public health problems of the
21st century Annual medical expenditures attributable to obesity
have doubled in less than a decade, and may be as high as $147
billion per year, according to a new study by researchers at RTI
International, the Agency for Healthcare Research and Quality, and
the U.S. Centers for Disease Control & Prevention.
[0007] The study, published on the Health Affairs' website, reports
that, between 1998 and 2006, the prevalence of obesity (body mass
index greater than 30) increased by 37 percent. This increase is
responsible for 89 percent of the increase in obesity costs that
occurred during this time period. The results reveal that obesity
is now responsible for 9.1 percent of annual medical expenditures,
compared with 6.5 percent in 1998. The medical costs attributable
to obesity are almost entirely a result of costs generated from
treating the diseases that obesity promotes.
[0008] There have been several approached to treat obesity. The
primary treatment for obesity is dieting and physical exercise. If
this fails, anti-obesity drugs may be taken to reduce appetite or
inhibit fat absorption. In severe cases, there are different
surgery possibilities. Bariatric surgery, or weight loss surgery,
is performed on the stomach and intestine of people who are
dangerously obese, for the purpose of losing weight. The two most
common procedures are the Roux-en-Y, which closes off a portion of
the stomach and bypasses part of the intestine; and gastric
banding, which places a band around the stomach. In long-term
studies, the procedures caused a significant long-term loss of
weight, recovery from diabetes, improvement in cardiovascular risk
factors, and a reduction in mortality of 23% to 40%.
[0009] Another option is the laparoscopic bariatric surgery that
requires a hospital stay of 1-2 days. Short-term complications from
laparoscopic adjustable gastric banding are lower than laparoscopic
Roux-en-Y surgery, and complications from laparoscopic Roux-en-Y
surgery are lower than open Roux-en-Y surgery, although gastric
banding and Roux-en-Y do not have the same long term effects,
according to a July 2009 study of experienced centers. Overall,
30-day mortality from the surgery itself was 0.3% and the rate of
major complications was 4.3%. Gastric banding had no deaths and
4.8% major complications; laparoscopic Roux-en-Y had 0.2% surgical
deaths and 1.0% major complications, and open Roux-en-Y had 2.1%
surgical deaths and 7.8% major complications, in 4,776 patients
with an average body mass index (BMI) of 46.5. Complications were
higher in patients with higher BMIs and obstructive sleep
apnea.
[0010] The National Institutes of Health recommends bariatric
surgery for obese people with a BMI of at least 40, and for people
with BMI 35 and serious coexisting medical conditions such as
diabetes.
[0011] There are several bariatric procedures known in the art. For
example, US Patent Application Serial Number 2006/0047289 of the
inventor of the present invention teaches about a bariatric
procedure named endoscopic tissue apposition device that includes a
vacuum chamber configured to securely hold a portion of tissue
therein, the vacuum chamber being defined by a proximal wall and a
distal wall opposite to the proximal wall. Working and vacuum
channels are provided in communication with the vacuum chamber. A
portion of tissue is held in the vacuum chamber when the vacuum is
applied in the vacuum chamber through the vacuum channel. A carrier
needle is disposed on a proximal side of the vacuum chamber and is
longitudinally advanceable into and across the vacuum chamber,
while a punch needle is disposed on a distal side of the vacuum
chamber and is configured to receive the carrier needle therein. A
hold and release mechanism holds and releases the punch needle to
facilitate joining portions of tissue together.
[0012] Also the USSN 2003/0208209 of Richard A. Gambale et al.
discloses an improved endoscopic tissue apposition device having
multiple suction ports that permits multiple folds of tissue to be
captured in the suction ports with a single positioning of the
device and attached together by a tissue securement mechanism such
as a suture, staple or other form of tissue bonding. The
improvement reduces the number of intubations required during an
endoscopic procedure to suture tissue or join areas of tissue
together. The suction ports may be arranged in a variety of
configurations on the apposition device to best suit the desired
resulting tissue orientation. The tissue apposition device may also
incorporate a tissue abrasion means to activate the healing process
on surfaces of tissue areas that are to be joined by the operation
of the device to promote a more secure attachment by permanent
tissue bonding.
[0013] U.S. Pat. No. 6,773,440 of Gannoe et al. describes a device
for use in acquiring tissue folds from the anterior and posterior
portions of 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 bridge forms
excluding the pouch from the greater stomach cavity. It also
includes a transoral, endoscopic hollow organ division, including a
tissue acquisition device capable of acquiring the desired tissue,
a tensioning device for positioning the acquired tissue, and a
fastening element to secure the outer layers of the acquired tissue
such that the desired healing response is achieved.
[0014] U.S. Pat. No. 7,122,058 of Levine et al. describes an
apparatus for limiting absorption of food products in specific
parts of the digestive system. A gastrointestinal implant device is
anchored in the stomach and extends beyond the ligament of Treitz.
All food exiting the stomach is funneled through the device. The
gastrointestinal device includes an anchor for anchoring the device
to the stomach and a flexible sleeve to limit absorption of
nutrients in the duodenum. The anchor is collapsible for endoscopic
delivery and removal.
[0015] U.S. Pat. No. 7,172,613 of Wazne describes an intragastric
device inserted by endoscopic path into a patient's stomach. The
device includes a balloon or envelope having a specific nominal
volume. The balloon is sealingly connected to connecting elements
consisting of a disc forming a support base for the balloon against
an inner wall of the stomach. The device also includes a flexible
tube or catheter for connecting the balloon to a filling device and
catching element integral with the tube or catheter. The connection
elements enable a doctor to set and/or remove the balloon and to
fix, either inside the patient's body, or subcutaneously the
filling device and to be able to bring the balloon or envelope to
its predetermined nominal volume.
[0016] Even though all the above mentioned methods and devices
represent a partial solution, they are very invasive and sometimes
the patient needs to be hospitalized for a couple of days. The
risks are higher than recommended or the costs and time involved
for the procedure are extremely high.
[0017] As such, an endoscopic implantable device and method for the
apposition of the stomach walls for reducing the stomach internal
volume is still desired in the market.
SUMMARY OF THE INVENTION
[0018] A main object of the present invention is to provide an
implantable device for reducing the stomach volume without having
to stitch the stomach walls, using a procedure that only takes
several minutes with no risk to the patient's life.
[0019] Another object of the present invention is to provide a
method for reducing the stomach volume by introducing a device
which grabs the stomach walls and keeps them united for a period of
time the surgeon considers appropriate to reduce the patient's
weight. After said time, the device may be taken out during an
additional reversing procedure or may be absorbed by the gastric
fluids with no side effects for the patient.
[0020] Another object of the present invention is to provide a
bariatric method for reducing the stomach internal volume by means
of a rapid and easy procedure involving the placement of an implant
into the stomach which grabs the stomach walls and keeps them
together until the surgeon decides to take it out of the stomach or
until the gastric fluids dissolve it.
[0021] Yet another object of the present invention is to provide an
endoscopic apposition device that is simple and economical to
produce and use.
[0022] According to another aspect of the invention, a tissue
apposition device is provided having longitudinal flexibility that
is easily navigable through a natural body lumen while mounted at
the distal end of an elongated tube.
[0023] Yet another aspect of the invention provides a method of
joining stomach tissue that comprises capturing at least two areas
of tissue at the same time by suction action and closing the
implant device to join them together.
[0024] Yet another aspect of the invention provides a method for
reducing the internal volume of an overweight patient, especially
useful for patients that are 60-80 lbs overweight.
[0025] Yet another aspect of the invention provides a method of
closing a bleeding fistula and/or a hemorrhage by placing a
biodegradable device on the critical place to close the injury.
[0026] In summary, the present invention is referred to an
endoscopic implantable device for the apposition of the stomach
walls for reducing the stomach internal volume, comprising an
elongated endoscopic tube at the distal end of which an apposition
means is attached, and at the external end means for managing said
apposition means are included; said endoscopic tube also includes a
vacuum channel connectable to a pump capable of creating a vacuum
effect on the distal end, and said apposition means comprising a
body releasably attached to the distal end of said flexible tube,
including two hinged halves, each halve with a double wall that
creates an internal chamber in fluid communication with the vacuum
channel of the elongated tube; the internal side of each halve has
a plurality of suction nozzles in fluid communication with said
chamber, and a set of grabbing teeth.
[0027] Also the invention is referred to a method for closing the
walls of the stomach during a weight loss procedure comprising the
steps of: [0028] a) navigating a distal end of the apposition
device into the patient's body to a treatment site; [0029] b)
comprising the apposition device an elongated tube at the distal
end therewhich an apposition means is attached, said apposition
means comprising a set of vacuum nozzles configured to securely
hold a portion of tissue therein, a set of grabbing and holding
teeth disposed on the outer edge of the device, a hold and release
mechanism which holds and releases said device; [0030] c) advancing
the device inside the stomach and opening it exposing the suction
nozzles to the inner walls of the stomach; [0031] d) putting fluid
communication in said nozzles with vacuum means; [0032] e) applying
the vacuum to the vacuum chamber; [0033] f) closing the device by
punching the teeth to the stomach tissue, to secure the portion of
tissue together; [0034] g) disconnecting the apposition means from
the elongate tube, and: [0035] h) extracting the elongated tube
from the patient's body.
[0036] These and other aspects, features, and advantages of the
present invention will become more readily apparent from the
attached drawings and the detailed description of the preferred
embodiments, which follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0037] The preferred embodiments of the invention will hereinafter
be described in conjunction with the appended drawings provided to
illustrate and not to limit the invention, where like designations
denote like elements, and in which:
[0038] FIG. 1 illustrates a general schematic view of a patient and
illustrates how the elongated tube enters the esophagus and into
the stomach with the purposed device inserted in the distal end
thereof.
[0039] FIG. 2 is a perspective view of the purposed device,
attached to the distal end of the elongated tube in its closed
position. In this figure the device is already placed into the
stomach, between the middle stomach and fundus.
[0040] FIG. 3 is a perspective view of the purposed device in an
open position, showing in detail the two hinged halves that define
the same, the suction nozzles and the mechanism that opens said
halves. In this case the device in open but the suction nozzles are
not suctioning yet. It is in a passive position.
[0041] FIG. 4 is another perspective view showing that the suction
effect has started and how the stomach walls go toward the suction
nozzles as a response to said suction effect.
[0042] FIG. 5 is a cross sectional view of the apposition means
showing the internal chamber in fluid communication with the
nozzles.
[0043] FIG. 6 is another perspective view showing how the stomach
walls remain inside the device, the halves have been closed and the
teeth and grabbing and keeping the tissue in place. The device is
still attached to the elongated tube and the procedure is almost
over; and finally:
[0044] FIG. 7 is another perspective view this time that the device
is no longer attached to the elongated tube. The surgeon has
decoupled the distal end of the elongated tube from the device and
taken the elongated tube out the patient's stomach and esophagus.
The device will remain inside the stomach reducing the internal
volume for the period of time the surgeon considers necessary to
reduce the patient's weight.
DETAILED DESCRIPTION OF REPRESENTATIVE EMBODIMENTS
[0045] The following detailed description is merely exemplary in
nature and is not intended to limit the described embodiments or
the application and uses of the described embodiments. As used
herein, the word "exemplary" or "illustrative" means "serving as an
example, instance, or illustration." Any implementation described
herein as "exemplary" or "illustrative" is not necessarily to be
construed as preferred or advantageous over other implementations.
All of the implementations described below are exemplary
implementations provided to enable persons skilled in the art to
make or use the embodiments of the disclosure and are not intended
to limit the scope of the disclosure, which is defined by the
claims. For purposes of description herein, the terms "upper",
"lower", "left", "rear", "right", "front", "vertical",
"horizontal", and derivatives thereof shall relate to the invention
as oriented in FIG. 1. Furthermore, there is no intention to be
bound by any expressed or implied theory presented in the preceding
technical field, background, brief summary or the following
detailed description. It is also to be understood that the specific
devices illustrated in the attached drawings, and described in the
following specification, are simply exemplary embodiments of the
inventive concepts defined in the appended claim. Hence, specific
dimensions and other physical characteristics relating to the
embodiments disclosed herein are not to be considered as limiting,
unless the claims expressly state otherwise.
[0046] The present invention provides an endoscopic implantable
device for the apposition of the stomach walls for reducing the
stomach internal volume, capable of securing a tissue site together
with a single intubation of an elongated tube carrying the device
at the distal end thereof into the stomach of the patient. To
position the suture in the appropriate locations, the purposed
device may be releasably secured to the distal end of any suitable
elongated tube. The device also includes a tissue vacuum chamber
that creates a suction effect and captures a section of stomach
tissue therein, closing the device and capturing a portion thereof
with a set of teeth.
[0047] Shown throughout the Figures, the invention is directed to
an endoscopic device 1 for reducing the internal volume of the
patient's stomach. To introduce this device 1 into the stomach, an
elongated tube 2 is used, comprising an elongated flexible body 3
with an upper end 4 and a distal end 5. Inside said tube 3, an
operating device 6 is included which provides two basic functions:
opening-closing the device and providing a suction means as will be
explained in detail below.
[0048] The above mentioned distal end 5 includes an operating head
7, including retention means 8 and two operating arms 9-10. Said
retention means 8 maintains the purposed device 1 attached to the
elongated tube 2, and the arms 9-10 open and close the device
halves.
[0049] The device comprises a cylindrical body defined by two
halves 20-21 each of which includes an upper end 20a-21a and a
distal end 20b-21b. On the inner surface of each half 20-21, a
plurality of suction nozzles 22 are included. Each nozzle is in
fluid communication with a suction means of the elongated tube 2.
Also a regular endoscope (not illustrated) may also be used to give
to the surgeon a visual indication of the site in which the device
will be placed. As illustrated in FIG. 3, said nozzles 22 are
evenly distributed on the inner surface of each half 20-21. This is
to create an even suction effect on the stomach wall.
[0050] On the external side 20c-21c of each half 20-21 an aligned
plurality of teeth 24 are included. The teeth 24 of half 20 are
slightly offset regarding teeth 24 of half 21 so as to create an
interlocking effect when the device is in the closed position
illustrated in FIG. 2.
[0051] FIG. 1 shows how the elongated tube with the purposed device
is inserted into the patient's body. As shown, it is not necessary
to make any incision in the skin and the stomach as in the
laparoscopic surgeries. The purposed system comprises a flexible
endoscopic device 1 designed to be inserted through the mouth into
the stomach. The procedure is performed under general anesthesia
and takes roughly half an hour to complete. Per the standard safety
protocol, the patient is placed on a respirator to help regulate
his/her breathing during the surgery. Once the patient 100 has been
sedated and is breathing comfortably, the endoscopic device 1 is
inserted into the mouth 101 and fed through the esophagus 102 to
the stomach 103. The bariatric surgeon will then insert the
operative commands 6 for controlling the device, including a
regular endoscope with a flexible camera to be able to see during
the procedure (not illustrated), the suction conduit which provides
the necessary suction effect to the suction nozzles, and the
opening-closing means. The device 1 is located inside the stomach
somewhere between the fundus 104 and the middle body 105 of the
stomach 103.
[0052] FIG. 2 illustrates the purposed device 1 in the stomach 103.
The device is closed so teeth 24 surround the external wall of the
device in an intermeshing pattern. Both halves 20-21 in this closed
position form a cylindrical piece and the length `h` will depend on
the patient's size. It is obvious that those patients who have a
larger body will need a longer (and consequently larger suction
surface) device.
[0053] FIG. 3 illustrates the purposed device in its open position.
In order to be able to open it, the surgeon must operate on the
controlling means 6. By turning a controlling wheel (not
illustrated) at the upper end of the elongated tube, the surgeon
will produce the rotation of arms 9-10 and consequently the
separation of halves 20-21 and thus the opening of device 1. When
the device is open, the inner surface of said halves 20-21 are
exposed to the internal wall of the stomach. The distribution of
the suction nozzles 22 in each half 20-21 will create an even
suction effect. Nevertheless, the illustration of several
vertically and horizontally aligned nozzles should not be
considered a limitation of the invention, as any other appropriate
pattern may be used, including a fewer number of nozzles and
nozzles of different sizes among each other. Also, the illustrated
arms 9-10 which control the opening of said halves 20-21 can also
be replaced by any other controlling device without departing from
the purposed concept.
[0054] FIG. 4 illustrates the device open and the moment in which
the surgeon connects and puts fluid communication in the vacuum
device included in the endoscope (not illustrated) and the suction
nozzles 24. This creates a strong suction effect (indicated with
the arrows towards the nozzles in this Figure) that attracts the
internal walls of the stomach to the device. As shown, the internal
walls of the stomach approach the device and make physical contact
with said nozzles 24. In this position, teeth 24 are inactive as
well as the controlling device that are defined by the arms 9-10,
which are in an `on-hold` state.
[0055] FIG. 5 shows the device closed, holding part of the inner
wall of the stomach 103. As a result of the above mentioned suction
effect, a section of the internal wall of the stomach 103 reaches
and takes contact with the inner walls of the device 1. In this
moment, the surgeon operates on the controlling means 6 so as to
close both halves 20-21 Said part of the stomach will remain inside
the device 1 and the tips of teeth 24 will be stacked into the
tissue, grabbing and keeping the tissue in place. It is important
to point out that the material used to manufacture the inner walls
of halves 20-21 is critical. The surgeon will leave the device in
the illustrated closed position for a long time (several weeks or
months) therefore the tissue of the stomach will be in permanent
contact with this material. In order to avoid the necrosis of this
tissue, the material used must be one of the several known
materials in the market used to be in permanent contact with this
tissue without creating problems for the patient.
[0056] FIG. 6 shows how the device will be left inside the stomach
once the procedure is over. The surgeon will operate for the last
time on the controlling means 6 to decouple the device from the
head 7 of said elongated tube 2. Once the procedure is completed,
the elongated tube 2 is withdrawn from the patient and the device 1
is left in the stomach. There are several alternatives for the
surgeon to take the device out of the patient's body once the
weight loss program reaches its goals. It may be manufactured out
of biodegradable materials which allow the natural dissolution of
the device in the gastric fluids. Another embodiment will involve
using durable materials which will demand a new procedure. In such
a case, the surgeon must insert the elongated tube again, couple
the head 7 of the upper end of said device 1 to the distal end of
the elongated tube, open the halves 20-21 for freeing the tissue of
the stomach, then close the device again and take it out.
[0057] It is anticipated that the process will be an ambulatory
process that is carried out using propofol intravenous
anesthesiology, whereupon the patient can expect to consume liquids
as soon as just few hours after the procedure is completed.
[0058] It is also possible to include, as part of the body of the
purposed device, a safety feature to avoid problems for the patient
in the case the device is disengaged from the stomach tissue after
the procedure. Even though the design of the present device and the
physical characteristics of the teeth used to grab the stomach
tissue will make this possibility very remote, a disengagement
between the device and the tissue may happen (for any reason). In
such a case, there is a risk the device may fall into the antrum
and then go to the pylorus, obstructing the stomach and putting the
life of the patient in risk. To avoid this, the device may include,
on its external body, several retention means defined by flexible
rounded rings or legs that will prevent the device from entering
into the pylorus in case a decoupling with the tissue happens. Said
retention means will have the function of keeping the device away
from the pylorus, having a diameter larger than the internal
diameter of the pylorus.
[0059] The present invention also involves a method for the
apposition of the stomach walls endoscopically comprising the steps
of: [0060] a) navigating a distal end of an endoscopic apposition
device to a treatment site, the apposition device having an
elongated tube at the end of which the apposition means is
attached, comprising a body with two hinged halves, each halve with
a double wall that creates an internal chamber in fluid
communication with a suction port of the elongated tube; the
internal side of each halve has a plurality of suction nozzles in
fluid communication with said chamber, and a set of grabbing teeth
disposed on the outer edge of the device, and a hold and release
mechanism; [0061] b) advancing the device inside the stomach;
[0062] c) opening said halves exposing the suction nozzles to the
inner walls of the stomach; [0063] d) putting fluid communication
in said nozzles with the vacuum means of the elongated tube; [0064]
e) applying vacuum to the internal chamber until the wall of the
stomach is attached to the inner walls of said halves; [0065] f)
closing the device by punching the teeth to the stomach tissue, and
securing the portion of tissue together; [0066] g) detaching the
endoscopic apposition device from the elongated tube; and [0067] h)
taking the device out of the patient's body.
[0068] When the present invention is used to create the apposition
of other types of tissues, for example, a perforated stomach, a
fistula, a hemorrhage, etc., the method for joining internal body
tissue endoscopically comprises the steps of: [0069] a) navigating
a distal end of an endoscopic apposition device to a treatment
site, the apposition device having a body with two hinged halves,
each halve with a double wall that creates an internal chamber in
fluid communication with a suction port of the elongated tube; the
internal side of each halve has a plurality of suction nozzles in
fluid communication with said chamber, and a set of grabbing teeth
disposed on the outer edge of the device, and a hold and release
mechanism; [0070] b) advancing the device inside the body of the
patient endoscopically; [0071] c) opening said halves exposing the
suction nozzles to the inner walls of the tissue to be joined;
[0072] d) putting fluid communication in said nozzles with the
vacuum means of the elongated tube; [0073] e) applying vacuum to
the internal chamber until the tissue to be joined is attached to
the inner walls of said halves; [0074] f) closing the device by
punching the teeth to the tissue, and securing the portion of
tissue together; [0075] g) detaching the endoscopic apposition
device from the elongated tube; and [0076] h) taking the device out
of the patient's body.
[0077] While the preferred embodiments of the invention have been
described above, it will be recognized and understood that various
modifications can be made in the invention and the appended claims
are intended to cover all such modifications which may fall within
the spirit and scope of the invention.
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