U.S. patent application number 17/004795 was filed with the patent office on 2021-01-21 for anchorless intragastric device for treating obesity.
The applicant listed for this patent is SynerZ Medical, Inc.. Invention is credited to Raghuveer Basude, Virender K. Sharma.
Application Number | 20210015645 17/004795 |
Document ID | / |
Family ID | 1000005134719 |
Filed Date | 2021-01-21 |
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United States Patent
Application |
20210015645 |
Kind Code |
A1 |
Sharma; Virender K. ; et
al. |
January 21, 2021 |
Anchorless intragastric Device For Treating Obesity
Abstract
A intragastric device that contains a compressible free-floating
structure and a sleeve attached thereto is provided. The device is
considered to be anchorless as the sleeve is not physically
attached to any portion of the GI tract. The device is configurable
between a compressed pre-deployment configuration and an expanded
post-deployment configuration. The free-floating device may be
composed of a shape memory material such a nitinol. In some
embodiments, the free-floating structure is space occupying and
non-porous. The sleeve may be attached to the free-floating
structure, such as with sutures and/or glue. In some embodiments, a
stent may be inserted at the proximal end of the sleeve. A second
free-floating structure may be connected to the free-floating
structure such that there is an upper structure and a lower
structure. In some embodiments, the gastrointestinal device is used
to deliver prebiotic and/or probiotic therapy to a patient.
Inventors: |
Sharma; Virender K.;
(Paradise Valley, AZ) ; Basude; Raghuveer;
(Freemont, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SynerZ Medical, Inc. |
Newark |
DE |
US |
|
|
Family ID: |
1000005134719 |
Appl. No.: |
17/004795 |
Filed: |
August 27, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15496625 |
Apr 25, 2017 |
10779980 |
|
|
17004795 |
|
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62328326 |
Apr 27, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 5/0036 20130101;
A61F 5/003 20130101; A61F 5/0076 20130101; A61F 5/0083
20130101 |
International
Class: |
A61F 5/00 20060101
A61F005/00 |
Claims
1.-20. (canceled)
21. An intragastric device comprising: a non-porous, compressible
anchoring structure having a spiral-shaped configuration with a
proximal end, a distal end, and an intermediate portion
therebetween that is wider than the proximal and distal ends; and
an elongate sleeve coupled to said distal end of said anchoring
structure and extending distally from said anchoring structure.
22. The intragastric device of claim 21, wherein said anchoring
structure is configured to provide positioning support to said
sleeve.
23. The intragastric device of claim 21, wherein said anchoring
structure comprises a shape memory material.
24. The intragastric device of claim 21, wherein said anchoring
structure has a diameter in from 3 mm to 30 mm at its widest
part.
25. The intragastric device of claim 21, wherein said sleeve is
attached to said anchoring structure by sutures, glue, or a
combination thereof.
26. The intragastric device of claim 21, further comprising a
second anchoring structure attached to said proximal end of said
compressible anchoring structure.
27. The intragastric device of claim 21, wherein the anchoring
structure comprises a flat material.
28. The intragastric device of claim 21, wherein the spiral-shaped
configuration of the anchoring structure is adapted for food to
enter through spaces in the spiral-shaped configuration.
29. The intragastric device of claim 21, wherein said anchoring
structure is configurable between a compressed configuration and an
expanded configuration.
30. An intragastric device comprising: an anchoring structure
including a plurality of loops; and an elongate sleeve extending
distally from said anchoring structure, said sleeve having an upper
proximal portion, a middle transitional portion, and a lower distal
portion, wherein said loops extend radially and outward from the
proximal end of said upper proximal portion of said sleeve, and
wherein said middle transitional portion has a diameter that
decreases in size from its proximal end to its distal end and
interconnects said upper proximal portion and said lower distal
portion.
31. The intragastric device of claim 30, wherein said loops are
interconnected around the circumference of said upper proximal
portion.
32. The intragastric device of claim 31, wherein said upper
proximal portion and said lower distal portion each has an
approximate consistent diameter along its length, wherein said
lower distal portion has a length that is greater than a length of
said upper proximal portion, and wherein a diameter of said upper
proximal portion is larger than a diameter of said lower distal
portion.
33. The intragastric device of claim 30, wherein said sleeve
further comprises a plurality of horizontal support elements along
a length of said middle transitional portion and said lower distal
portion.
34. The intragastric device of claim 30, wherein said sleeve
further comprises a plurality of vertical support elements in the
form of elongate metal wires.
35. The intragastric device of claim 30, wherein said anchoring
structure comprises a shape memory material.
36. The intragastric device of claim 30, wherein said anchoring
structure is configurable between a compressed configuration and an
expanded configuration.
37. The intragastric device of claim 30, wherein said sleeve
comprises a membrane.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/496,625, filed Apr. 25, 2017, which claims
the benefit of U.S. Provisional Application 62/328,326, filed Apr.
27, 2016, both of which are incorporated herein by reference in
their entireties for all purposes.
FIELD
[0002] The present specification relates generally to medical
devices useful in the treatment of obesity. More particularly, the
present specification relates to intragastric and gastrointestinal
devices of dynamic weight that reduce gastric volume, slow gastric
emptying, and/or bypass portions of the small intestine, thereby
leading to patient weight loss.
BACKGROUND
[0003] Obesity is a common condition and growing public health
problem in developed nations including the United States. As of
2009, more than two thirds of American adults, approximately 127
million people, were either overweight or obese. Over one third of
American adults are obese. Data suggest that 300,000 Americans die
prematurely from obesity-related complications each year. Many
children in the United States are also either overweight or obese.
Hence, the overall number of overweight Americans is expected to
rise in the future. It has been estimated that obesity costs the
United States over $100 billion annually in direct and indirect
health care expenses and in lost productivity. This trend is also
apparent in many other developed nations.
[0004] For adults, the body mass index (BMI) is used to determine
if one is overweight or obese. A person's BMI is calculated by
multiplying body weight in pounds by 703 and then dividing the
total by height in inches squared. A person's BMI is expressed as
kilograms per meter squared. An adult is considered overweight if
his or her BMI is between 25 and 30 kg/m2. Obesity is defined as
possessing a BMI between 30 and 40 kg/m2. A BMI greater than 30
kg/m2 is associated with significant co-morbidities. Morbid obesity
is defined as possessing either a body weight more than 100 pounds
greater than ideal or a BMI greater than 40 kg/m2. Approximately 5%
of the U.S. population meets at least one of the criteria for
morbid obesity. Morbid obesity is associated with many diseases and
disorders including, for example: diabetes; hypertension; heart
attack; stroke; dyslipidemia; sleep apnea; pickwickian
syndrome;
[0005] asthma; lower back and disc disease; weight-bearing
osteoarthritis of the hips, knees, ankles and feet;
thrombophlebitis and pulmonary emboli; intertriginous dermatitis;
urinary stress incontinence; gastroesophageal reflux disease
(GERD); gallstones; and, sclerosis and carcinoma of the liver. In
women, infertility, cancer of the uterus, and cancer of the breast
are additionally associated with morbid obesity. Taken together,
the diseases associated with morbid obesity markedly reduce the
odds of attaining an average lifespan. The sequelae raise annual
mortality rates in affected people by a factor of 10 or more.
[0006] Current treatments for obesity include diet, exercise,
behavioral treatments, medications, surgery (open and
laparoscopic), and endoscopic devices. New drug treatments for
obesity are currently being evaluated in clinical trials. However,
a high efficacy pharmaceutical treatment has not yet been
developed. Further, short-term and long-term side effects of
current pharmaceutical treatments often concern consumers,
pharmaceutical providers, and/or their insurers. Generally, diet or
drug therapy programs have been consistently disappointing, failing
to bring about significant, sustained weight loss in the majority
of morbidly obese people.
[0007] Currently, most operations used to treat morbid obesity
include gastric restrictive procedures, involving the creation of a
small (e.g., 15-35 ml) upper gastric pouch that drains through a
small outlet (e.g., 0.75-1.2 cm), setting in motion the body's
satiety mechanism. About 15% of operations used to treat morbid
obesity performed in the
[0008] United States involve combining a gastric restrictive
procedure with a malabsorptive procedure. Typical malabsorptive
procedures divide small intestinal flow into a biliary-pancreatic
conduit and a food conduit. Potential long-term side effects
associated with abdominal surgical procedures include herniation
and small bowel obstruction. In addition, long-term problems
specific to bariatric procedures also include gastric outlet
obstruction, marginal ulceration, protein malnutrition, and vitamin
deficiency.
[0009] Other surgical strategies for treating obesity include
endoscopic procedures, many of which are still in development.
Endoscopic procedures and devices to produce gastric pouch and
gastrojejunal anastomosis are used to replicate laparoscopic
procedures. Endoscopically placed gastric balloons restrict gastric
volume and result in satiety with smaller meals. For example, U.S.
patent application Ser. No. 10/221,562, now issued as U.S. Pat. No.
7,172,613 and assigned to Districlass Medical SA, 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."
[0010] The silicone intragastric balloon (IGB) has been developed
as a temporary aid to achieve weight loss specifically for people
who weigh 40% or more of their ideal weight and who have had
unsatisfactory results in their treatment of obesity, despite being
cared for by a multidisciplinary team. This treatment is also
indicated for morbidly obese patients who have a high morbidity and
mortality risk for surgery. The placement and removal of the IGB is
an endoscopic procedure and the balloon is designed to float freely
inside the stomach. The IGB technique reduces the volume of the
stomach and leads to a premature feeling of satiety. However, use
of IGBs did not show convincing evidence of a greater weight loss.
The relative risks for minor complications, for example, gastric
ulcers and erosions, were significantly raised. All inflatable IGB
devices suffer from the problem of deterioration of the balloon
over time. This deterioration can result in deflation with loss of
efficacy and complications such as small bowel obstruction
secondary to balloon migration. Due to loss of efficacy overtime,
IGB devices are recommended only for short (<6 month) durations.
In addition, rapid inflation of the balloon poses the risk of
esophageal or gastric perforations, both of which are surgical
emergencies. Deaths have been reported in patients using IGB
treatment.
[0011] Endoscopic procedures are also used to deploy mesh
structures into the stomach in an effort to occupy stomach volume
and create the artificial sensation of being full. For example,
U.S. patent application Ser. No. 11/657,231, assigned to
Wilson-Cook Medical, Inc., describes an "intragastric device
generally compris[ing] a strip digestive-resistant mesh material
that is operable between a first configuration and a second
configuration. The first configuration is sufficiently small to
permit introduction of the digestive-resistant mesh material into a
gastric lumen of the mammal. The second configuration is
sufficiently large to prevent the digestive-resistant mesh material
from passing through the mammal's pylorus, thereby permitting the
mesh member to act as an artificial bezoar."
[0012] Although endoscopically placed balloon structures can be
effective, they are not without their associated risks and
complications. Mesh structures are effective in occupying available
gastric volume but they do not address gastric emptying. Migration
and small bowel obstruction from such devices continue to remain a
significant problem. Therefore, a need exists for an intragastric
device to treat obesity that combines the benefits obtained through
reducing stomach volume, slowing gastric emptying, and providing a
bypass for food past the pylorus and a portion of the small
intestine, while remaining relatively safe. The device should also
include a component for preventing migration of the entire device
out of the stomach. This device should limit side effects and be
able to be deployed and removed in a non-invasive manner with
relative ease. In addition, this device should have the option of
further treating obesity by including the benefits obtained by
malabsorptive diversion procedures. The addition of this optional
benefit would make the device effective in treating not only
obesity, but type II diabetes as well.
[0013] Typical metal structures cannot survive the hostile
environment, particularly with respect to the high acidity, of the
stomach. Intragastric devices comprising acid-sensitive components,
such as metal wires, are typically covered or coated in an
acid-resistant material (i.e. silicone) to prevent degradation of
these components by acidic gastric contents. Conventional
manufacturing processes for creating these coated intragastric
devices first coat the metal wires of the device and then form the
wires into the desired end shape of the device. As the shapes and
structures of intragastric devices become more complicated, these
conventional processes are unable to properly create the desired
end product. A shape memory metal, such as Nitinol, is heat-set at
temperatures in excess of 400.degree. C. Coating the metal with an
acid-resistant material and then heat-setting into the final shape
would result in destruction of the coating during exposure to the
high temperatures. Therefore, a method of manufacture is needed
wherein the wires of the intragastric device are first formed into
the desired end shape and are then coated with a
corrosion-resistant material. Such a method will take care to
prevent the coating and covering or clogging of the spaces or
openings between the wires of the wire mesh. Such a method will
also produce a finished device that is still flexible enough to be
converted from a compressed, first pre-deployment shape to an
expanded, post-deployment shape.
[0014] Specific surgical options for the treatment of obesity also
include laparoscopic sleeve gastrectomy (LSG) and laparoscopic
roux-en-y-gastric bypass (RGB) surgery. Gastrectomy refers to a
partial or full surgical removal of the stomach. LSG is a
restrictive treatment, surgical weight-loss procedure in which the
stomach is reduced to approximately 25% of its original size by
surgical removal of a large portion following the major curve. The
open edges are then attached together (often with surgical staples)
to form a sleeve or tube with a banana shape. The procedure
permanently reduces the size of the stomach. The procedure is
performed laparoscopically and is not reversible. Following the
operation, the stomach empties its contents rapidly into the small
intestine, but with little or no vomiting (characteristic of other
restrictive procedures).
[0015] LSG involves a longitudinal resection of the stomach on the
greater curvature from the antrum starting opposite the nerve of
Latarjet up to the angle of His. The first step of the procedure is
the division of the vascular supply of the greater curvature of the
stomach which is achieved with the section of the gastro-colic and
gastro-splenic ligaments close to the stomach. The greater
curvature is completely freed up to the left crus of the diaphragm
to resect the gastric fundus that harbors the ghrelin secreting
cells of the stomach. The second step of the procedure is the
longitudinal gastrectomy that "sleeves" the stomach to reduce its
shape to a narrow tube. The pylorus and part of the antrum are
preserved, resulting in a lesser curvature-based "restrictive"
gastric sleeve.
[0016] Sleeve gastrectomy (also called gastric sleeve) is usually
performed on extremely obese patients, with a body mass index of 40
or more, where the risk of performing a gastric bypass or duodenal
switch procedure may be too large. A two-stage procedure is
performed: the first is a sleeve gastrectomy; the second is a
conversion into a gastric bypass or duodenal switch. Patients
usually lose a large quantity of their excess weight after the
first sleeve gastrectomy procedure but, if weight loss ceases, the
second step is performed.
[0017] For patients that are obese but not extremely obese, sleeve
gastrectomy alone is a suitable operation with minimal risks.
Sleeve gastrectomy is currently an acceptable weight loss surgery
option for obese patients as a single procedure. Most surgeons
prefer to use a bougie (tapering cylindrical instrument) having an
outer diameter between 32-60 French (the optimal bougie size is 32
Fr-36 Fr) with the procedure. The ideal approximate remaining
capacity of the stomach after the procedure is 15 ml.
[0018] One of the mechanisms involved in weight loss observed after
the LSG is the dramatic reduction of the capacity of the stomach.
The concept of restriction has been widely used in bariatric
surgery in vertical banded gastroplasty (VBG) and laparoscopic
adjustable gastric banding (LAGB). The distension of the small
gastric pouch in the LAGB procedure or VBG is intended to account
for the feeling of early fullness, enhanced satiety and decreased
hunger experienced by a patient after the ingestion of small
quantities of food.
[0019] The hormonal modifications induced by LSG differ from those
found after a purely restrictive procedure such as LAGB. Ghrelin, a
peptide hormone mainly produced in the fundus of the stomach, is
believed to be involved in the mechanisms regulating hunger. There
is a significant reduction in ghrelin associated with resection of
the gastric fundus.
[0020] What makes LSG a preferable option lies in the fact that the
operation is a straightforward procedure that can generally be
completed laparoscopically, even in the case of an extremely obese
patient. It does not involve any digestive anastomosis and no
mesenteric defects are created, eliminating the risk of internal
hernia. In addition, no foreign material is used as in the case of
gastric banding, the whole digestive tract remains accessible to
endoscopy, and it is not associated with Dumping syndrome. Also,
the risk of peptic ulcer is low and the absorption of nutrients,
vitamins, minerals and drugs is not altered.
[0021] Early reports of LSG have shown it to be safe and effective
with marked weight loss and significant reduction of major
obesity-related comorbidities. The question whether LSG may work as
a sole bariatric procedure in the long term cannot yet be answered.
For this reason, LSG is proposed as the first step of a staged
approach in patients for whom a biliopancreatic diversion with
duodenal switch (BPD-DS) or RGB seems too hazardous because of a
very high BMI (super obesity=BMI>50 or super-super
obesity=BMI>60) and/or associated diseases whether related or
not to obesity.
[0022] Laparoscopic roux-en-y-gastric bypass (RGB) involves the
creation of a small (20-30 m I) gastric pouch and a Roux limb
(typically 75-105 cm) that reroutes a portion of the alimentary
tract to bypass the distal stomach and proximal small bowel.
Following RGB, a pleiotropic endocrine response may contribute to
improved glycemic control, appetite reduction, and long-term
changes in body weight. RGB also has a profoundly positive impact
on obesity-related comorbidities and quality of life. Other
advantages include established long-term effectiveness for
sustained weight loss, reduction of comorbidities, minimal risk for
long-term nutritional sequelae, and effective relief of
gastroesophageal reflux disease (GERD). RGB is not without risks.
Common causes of death include pulmonary embolism and anastomotic
leaks. Nonfatal perioperative complications include anastomotic
leaks, venous thromboembolism, wound infections, small bowel
obstruction, and bleeding. Postoperative gastrointestinal
complications include nausea and vomiting, micronutrient
deficiencies, and possible weight regain.
[0023] Failures after these bariatric procedures are common and
patients start regaining weight or the progressive weight loss
stops at a sub-therapeutic level. Therefore, there is a need for
salvage therapy after one or more failed bariatric procedures. What
is needed is a device to be used following bariatric surgery that
will combine the benefits of gastric volume reduction,
bilio-pancreatic diversion and/or intestinal bypass to enhance the
weight loss effects of the device. What is also needed is a device
that will further reduce the volume of a surgically restricted
stomach to reduce the amount of calories that can be consumed. The
device will also bypass the proximal small intestine or the roux
limb of the intestine in order to produce intestinal mal
absorption, bilio-pancreatic diversion or both. The device can
further act to delay gastric emptying, release the gastric hormones
associated with satiety, and stimulate the gastric nerves
associated with sensation of satiety. The device could be combined
with other therapeutic agents such as electrical stimulation,
magnetic stimulation, or pharmaceutical agents.
[0024] The device can be used as a primary therapeutic procedure
for weight loss or as a bridge to surgery for a definitive weight
loss procedure. The device may also be used in the treatment of
other conditions including, but not limited to, metabolic syndrome,
diabetes mellitus, dyslipidemias and cardiovascular disease.
SUMMARY
[0025] The present specification discloses an intragastric device
for treating obesity comprising: a compressible component having a
pre-deployment configuration and a post-deployment configuration
and adapted to be positioned and free-floating within a stomach of
a patient when in said post-deployment configuration; and a sleeve
having a proximal end, a distal end, and a lumen within wherein
said sleeve is attached at its proximal end to a distal end of said
compressible component and extends through a pylorus of said
patient such that said distal end of said sleeve is positioned
within a mid-duodenum of said patient, further wherein said sleeve
is configured to transit food from said stomach of said patient to
said mid-duodenum such that said food bypasses said pylorus and a
proximal duodenum of said patient; wherein said compressible
component is configured to occupy space in said stomach and provide
positioning support to said sleeve such that said sleeve does not
migrate in a distal direction into a patient's jejunum or more than
5 cm in a proximal direction in said stomach, further wherein said
compressible component does not include food sequestering or
delayed gastric emptying properties.
[0026] The intragastric device may be configured to be delivered by
a catheter.
[0027] Optionally, the compressible component is composed of a
shape memory metal. The shape memory metal may be Nitinol.
Optionally, the intragastric device further comprises a non-porous
balloon positioned over said shape memory metal and configured to
reduce the exposure of said shape memory metal to gastric acid. The
balloon may be inflatable with air, water, and saline. The
intragastric device may be configured to have a functional life of
at least one year wherein functional life is defined as a time
period before said shape memory metal begins to degrade as a result
of expose to gastric acid. The balloon may be sutured to said
compressible component.
[0028] Optionally, the intragastric device further comprises a
stent positioned between said compressible component and said
sleeve and configured to be positioned in said pylorus.
[0029] The compressible component may have a shape comprising any
one of a balloon, double balloon, ball, parachute, inverted
parachute, disc, double disc, horseshoe, flower, teardrop, double
teardrop, cylinder, inverted square pyramid, funnel, bobbin, lotus,
wine glass, or orange peel.
[0030] The sleeve may have a shape comprising any one of a cylinder
or funnel.
[0031] Optionally, the compressible component and the sleeve are
not physically attached at any point to a patient's anatomy.
[0032] Optionally, the compressible component and the sleeve are
configured to be atraumatic to the patient's anatomy.
[0033] The compressible component may be configured to apply
pressure to said stomach to induce a feeling of fullness or satiety
in said patient.
[0034] Optionally, the intragastric device further comprises a
second compressible component attached to a proximal end of said
compressible component configured to occupy additional stomach
space and provide additional pressure to said stomach.
[0035] Optionally, the compressible component further comprises a
collar at its distal end configured to assist in positioning said
sleeve.
[0036] The present specification also discloses a gastrointestinal
device for treating obesity comprising a three-dimensional porous
structure configurable between a compressed pre-deployment
configuration to facilitate delivery and an expanded
post-deployment configuration. The porous structure includes a
first opening at its proximal end and a larger second opening at
its distal end. The porous structure also includes a sleeve coupled
to its distal end. Optionally, the device further includes a suture
at the proximal end of the wire mesh structure to facilitate
retrieval and an anti-migration component positioned at the
junction of the porous structure with the sleeve. The porous
structure is deployed in a patient's stomach such that the
anti-migration component sits proximal to the patient's pylorus and
prevents migration of the entirety of the device into and through
the pylorus. The sleeve extends through the pylorus, into the
duodenum and ends in the duodenum or jejunum. Food enters the
device from the first opening at the proximal end of the porous
structure, passes through the porous structure and sleeve, and
exits at the distal end of the sleeve. The device treats obesity by
providing a relatively immovable volume occupying structure in the
stomach and a bypass for food past the pylorus and proximal portion
of the small intestine. Optionally, the device further acts to slow
the passage of food through the digestive tract. Patients with the
device experience satiety more quickly and have a prolonged
sensation of satiety. Optionally, the device is anchorless and
atraumatic. Optionally, the intragastric device is used to deliver
prebiotic and/or probiotic therapy to the patient.
[0037] The aforementioned and other embodiments of the present
invention shall be described in greater depth in the drawings and
detailed description provided below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] These and other features and advantages of the present
invention will be appreciated as they become better understood by
reference to the following detailed description when considered in
connection with the accompanying drawings, wherein:
[0039] FIG. 1 is an illustration of an upper gastrointestinal
system;
[0040] FIG. 2A is an illustration of a wire mesh structure in a
post-deployment configuration with a proximally sloping
anti-migration disc or collar attached to its distal end, in
accordance with one embodiment of the present specification;
[0041] FIG. 2B is an illustration of a wire mesh structure in a
post-deployment configuration with a proximally curving
anti-migration collar formed at its distal end, in accordance with
one embodiment of the present specification;
[0042] FIG. 3A is a close-up illustration of an atraumatic
anti-migration collar of a wire mesh structure of an intragastric
device, in accordance with one embodiment of the present
specification;
[0043] FIG. 3B is a close-up illustration of an atraumatic
anti-migration collar of a wire mesh structure of an intragastric
device, in accordance with another embodiment of the present
specification;
[0044] FIG. 3C is a close-up illustration of a hoop for suturing a
proximal end of a sleeve component in accordance with one
embodiment of the present specification;
[0045] FIG. 3D is a close-up illustration of the hoop in accordance
with another embodiment of the present specification;
[0046] FIG. 4A is an illustration of a portion of a sleeve
component of an intragastric device in a post-deployment
configuration in accordance with one embodiment of the present
specification, depicting a single wire support spiraling along the
body of the sleeve;
[0047] FIG. 4B is an illustration of a portion of a sleeve
component of an intragastric device in a post-deployment
configuration in accordance with one embodiment of the present
specification, depicting multiple wire supports spiraling along the
body of the sleeve;
[0048] FIG. 4C is an illustration of a funnel shaped sleeve
component of an intragastric device in a post-deployment
configuration in accordance with one embodiment of the present
specification, depicting spiral wire loop supports on the
sleeve;
[0049] FIG. 5 is an illustration of a wire mesh structure with
attached sleeve component in a post-deployment configuration in
accordance with one embodiment of the present specification,
depicting a blunt end of a wire mesh support toward the proximal
end of the sleeve;
[0050] FIG. 6 is an illustration of an intragastric device with a
funnel shaped sleeve in a post-deployment configuration, in
accordance with one embodiment of the present specification;
[0051] FIG. 7 is an illustration of an intragastric device with a
cylindrically shaped sleeve in a post-deployment configuration, in
accordance with one embodiment of the present specification;
[0052] FIG. 8A is a close-up illustration of a funnel shaped sleeve
attached to an anti-migration collar of a wire mesh structure of an
intragastric device, in accordance with one embodiment of the
present specification;
[0053] FIG. 8B is a close-up illustration of a funnel shaped sleeve
attached to an anti-migration collar of a wire mesh structure of an
intragastric device and having a proximal sleeve end having frayed
edges, in accordance with another embodiment of the present
specification;
[0054] FIG. 8C is an illustration of an intragastric device
comprising a wire mesh structure and attached sleeve, in accordance
with one embodiment of the present specification;
[0055] FIG. 8D is an illustration of the intragastric device of
FIG. 16C with the sleeve straightened to depict the device
dimensions relative to the surrounding anatomy;
[0056] FIG. 8E is an illustration of a wire mesh structure and
sleeve of an intragastric device, depicting retrieval drawstrings
on said wire mesh structure, in accordance with one embodiment of
the present specification;
[0057] FIG. 8F is an illustration of a wire mesh structure and
sleeve of an intragastric device, depicting a single retrieval
drawstring on said wire mesh structure, in accordance with one
embodiment of the present specification;
[0058] FIG. 9A is a cross-sectional illustration of a distal end of
a sleeve, depicting one embodiment of a component designed to
configure said distal end to be atraumatic to body tissues;
[0059] FIG. 9B is a cross-sectional illustration of a distal end of
a sleeve, depicting another embodiment of a component designed to
configure said distal end to be atraumatic to body tissues;
[0060] FIG. 9C is a cross-sectional illustration of a distal end of
a sleeve, depicting another embodiment of a component designed to
configure said distal end to be atraumatic to body tissues;
[0061] FIG. 10 is an illustration of a distal end of a sleeve with
a positioning tail attached thereto, in accordance with one
embodiment of the present specification;
[0062] FIG. 11A is an illustration of a distal end of a sleeve
comprising a plurality of fringes joined to a ball, in accordance
with one embodiment of the present specification;
[0063] FIG. 11B is an illustration of a distal end of a sleeve
having at least one suture with attached suture loop or bead
extending therefrom, in accordance with one embodiment of the
present specification;
[0064] FIG. 12A is an illustration of an intragastric device having
an oval shaped wire mesh structure deployed in the gastrointestinal
tract of a patient, in accordance with one embodiment of the
present specification;
[0065] FIG. 12B is an illustration of an intragastric device having
an oval shaped wire mesh structure deployed in the gastrointestinal
tract of a patient, in accordance with another embodiment of the
present specification;
[0066] FIG. 13A is an illustration of a first exemplary delivery
device for an intragastric device, in accordance with one
embodiment of the present specification;
[0067] FIG. 13B is a flow chart illustrating the steps involved in
delivering an intragastric device using the delivery device of FIG.
13A, in accordance with one embodiment of the present
specification;
[0068] FIG. 14A is an illustration of a wire mesh structure of an
intragastric device being loaded onto a delivery device, in
accordance with one embodiment of the present specification;
[0069] FIG. 14B is an illustration of the wire mesh structure of
FIG. 14A further loaded onto the delivery device;
[0070] FIG. 14C is an illustration of the wire mesh structure of
FIG. 14A loaded onto the delivery device such that only the
anti-migration collar remains to be loaded;
[0071] FIG. 14D is an illustration of the wire mesh structure of
FIG. 14A fully loaded onto the delivery device;
[0072] FIG. 14E is an illustration of a sleeve of the intragastric
device of FIG. 14A partially loaded onto the delivery device;
[0073] FIG. 14F is an illustration of the intragastric device of
FIG. 14A fully loaded onto the delivery device;
[0074] FIG. 15A is an illustration of a retrieval device for
removing an intragastric device, in accordance with one embodiment
of the present specification;
[0075] FIG. 15B is a flow chart illustrating the steps involved in
removing an intragastric device from a patient using the retrieval
device of FIG. 15A, in accordance with one embodiment of the
present specification;
[0076] FIG. 16A shows a balloon covered wire mesh device before
deployment, compressed to the size of a capsule, according to one
embodiment;
[0077] FIG. 16B shows a post deployment configuration of the
device, according to one embodiment of the present
specification;
[0078] FIG. 17 illustrates one embodiment of an anchorless device
comprising a compressible free-floating structure in the stomach
with an attached sleeve, according to one embodiment of the present
specification;
[0079] FIG. 18A illustrates another embodiment of a free floating
structure with sleeve before deployment;
[0080] FIG. 18B illustrates a free floating structure with sleeve
after deployment, in accordance with another embodiment of the
present specification;
[0081] FIG. 19 illustrates another embodiment of an anchorless
device comprising a compressible free-floating structure with an
attached sleeve, according to one embodiment of the present
specification;
[0082] FIG. 20A illustrates another embodiment of the free floating
structure before deployment, according to one embodiment;
[0083] FIG. 20B illustrates a circular mesh-shaped structure after
deployment, according to one embodiment;
[0084] FIG. 21A is an illustration of an intragastric device having
an oval shaped wire mesh structure, in accordance with one
embodiment of the present specification.
[0085] FIG. 21B is an illustration of an intragastric device having
an oval shaped wire mesh structure, in accordance with another
embodiment of the present specification;
[0086] FIG. 22 illustrates another embodiment of an anchorless
device comprising a free-floating structure with an attached
sleeve, according to one embodiment of the present
specification;
[0087] FIG. 23 illustrates another embodiment of an anchorless
device comprising a free-floating structure with an attached
sleeve, according to one embodiment of the present
specification;
[0088] FIG. 24 illustrates another embodiment of an anchorless
device comprising a free-floating structure with an attached collar
and a sleeve, according to one embodiment of the present
specification;
[0089] FIG. 25A illustrates another embodiment of a free floating
structure, where the free floating structure is flower-shaped;
[0090] FIG. 25B illustrates another embodiment of a free floating
structure, where the free floating structure is flower-shaped;
[0091] FIG. 25C illustrates another embodiment of a free floating
structure, where the free floating structure is flower-shaped;
[0092] FIG. 26 illustrates yet another embodiment of an anchorless
device comprising a free-floating structure with an attached
sleeve, according to one embodiment of the present
specification;
[0093] FIG. 27 illustrates another embodiment of a free floating
structure, where the free floating structure is lotus-shaped;
[0094] FIG. 28 illustrates yet another embodiment of an anchorless
device comprising a free-floating structure with an attached
sleeve, according to one embodiment of the present
specification;
[0095] FIG. 29 illustrates another embodiment of a free floating
structure, where the free floating structure is wine
glass-shaped;
[0096] FIG. 30 illustrates another embodiment of an anchorless
device comprising a free-floating structure with an attached
sleeve, according to one embodiment of the present
specification;
[0097] FIG. 31 illustrates yet another embodiment of the free
floating structure, where the free floating structure is
microphone-shaped, according to one embodiment of the present
specification;
[0098] FIG. 32 provides an illustration of a stent support for a
sleeve component of an intragastric device, in accordance with one
embodiment of the present specification;
[0099] FIG. 33 provides another illustration of a stent support for
a sleeve component of an intragastric device, in accordance with
one embodiment of the present specification; and
[0100] FIG. 34 illustrates another embodiment of an anchorless
device comprising a free-floating structure with an attached
sleeve, according to one embodiment of the present
specification.
DETAILED DESCRIPTION
[0101] In one embodiment, the present specification is directed
toward an intragastric device of dynamic weight used in obese
patients to induce weight loss. In various embodiments, the
intragastric device comprises a porous three dimensional structure
having a pre-deployment shape and a post-deployment shape. In one
embodiment, the porous three dimensional structure is a
non-inflatable wire mesh structure, or a spiral structure made of
shape memory metal or shape memory polymer that changes from a
pre-deployment compressed cylindrical shape to a post-deployment
sphere, oval, kidney bean or any predefined shape of significant
volume. In another embodiment, the intragastric device is made of a
plastic material or a polymer such as polyether ether ketone (PEEK)
or polyester or a bioresorbable material. The device changes back
and forth from the pre-deployment to post-deployment shape by
minimal mechanical force and/or temperature changes arising from
the room temperature pre-deployment shape to the body temperature
post-deployment shape.
[0102] In another embodiment, the device comprises compressible
free-floating structure in the stomach with an attached sleeve
which passes through the pylorus and into the duodenum. The device
in this embodiment is anchorless and atraumatic, as it is not
physically attached to any part of the GI tract and does not damage
the GI tissue.
[0103] In one embodiment, the device is delivered endoscopically to
the stomach via a catheter. The device can be placed through the
endoscope, over an endoscope or over a guidewire with endoscopic or
fluoroscopic guidance/assistance.
[0104] The device has a pre-deployment compressed shape to
facilitate insertion and a post-deployment expanded shape that
resides in the gastric lumen. Post-deployment volume of the device
is significantly larger than pre-deployment volume. In one
embodiment, the post-deployment device has a volume of at least 100
ml. The post-deployment device occupies a significant volume in the
stomach, thereby reducing available gastric volume available for
storage of ingested food. This restricts the amount of food intake,
inducing satiety and curbing one's appetite. In one embodiment, the
device is also designed to intermittently, with gastric
peristalsis, slow or block the passage of the food from the stomach
into the small intestine, thereby slowing gastric emptying. In
various embodiments, the device also functions to create a
biliopancreatic diversion, either by bypassing ingested food past
pancreatic secretions or by bypassing pancreatic secretions past
ingested food.
[0105] In one embodiment, the device comprises a shape memory metal
and self-expands once deployed to change from the pre-deployment
shape to the post-deployment shape. In another embodiment, the
device comprises a temperature sensitive metal that is cooled in
its pre-deployment shape and then self-expands when exposed to
human body temperature to achieve its post-deployment shape. In
another embodiment, an expansion tool is used to apply minimal
mechanical force to change the device shape from its pre-deployment
shape to its post-deployment shape. In another embodiment, a
plastic, polymer, carbon fiber or a bioresorbable material is used
to construct the intragastric device.
[0106] In one embodiment, the wire structure contains differently
weighted material to assist in proper positioning within the
stomach. In one embodiment, lighter weighted material is positioned
at the top of the wire structure proximate to the top openings and
heavier weighted material is positioned at the bottom of the
structure, proximate to the bottom openings. This differential
weighting insures that the device will be properly situated within
the stomach to effectuate the intended effect of slower gastric
emptying. In addition, the differential weighting provides for
proper gastric positioning without the need of physically anchoring
the wire mesh structure to the stomach wall. The differential
weight property can also be provided by the ingested food material
that enters the device and is selectively accumulated toward the
bottom of the device facilitated by the gravitational pull. The
differential weight can also be provided by using different amounts
of material in the top and bottom halves. The wire mesh structure
is free to move about within the stomach while still maintaining
its correct top to bottom alignment facilitated by the
gravitational pull.
[0107] In one embodiment, the device comprises a wire mesh
structure which, when in the post-deployment shape, includes mesh
openings between the wires of the mesh structure. In one
embodiment, the mesh openings are greater than 1 mm in diameter. In
one embodiment, the wires of the wire mesh structure are coated
with a corrosion-resistant material. The corrosion resistant
material prevents exposure and subsequent degradation of the wires
of the wire mesh structure from acidic gastric contents once
deployed. The corrosion-resistant material completely covers the
wires of the wire mesh but does not cover the mesh openings. In one
embodiment, the corrosion-resistant material comprises parylene.
Parylene is beneficial as a coating in that it is durable, may
mitigate nickel ion leaching, and has a lower profile (is thinner
once applied). In various embodiments, the corrosion-resistant
material comprises silicone, polyester, polyether ether ketone
(PEEK), a medical grade epoxy, ceramic, an additional metal, or any
other suitable, flexible corrosive resistant material. In one
embodiment, the coating metal is tantalum. Tantalum provides
corrosive resistance and radiopacity. In one embodiment, wherein
the coating is ceramic, the ceramic coating has a thickness of
several angstroms. In various embodiments, any one or combination
of the above corrosive resistant materials is used to coat the
metal of the wire mesh structure.
[0108] In one embodiment, the mesh openings are differentially
structured to regulate the flow of food in and out of the mesh. In
one embodiment, at least one opening on the bottom half of the
device is larger than any of the openings on the upper half of the
device, allowing food entering the mesh to exit without the need
for further reduction in size of food material.
[0109] In another embodiment, the intragastric device further
includes an anti-migration component, or collar, coupled to a
portion of its distal end. The anti-migration component, similar to
the wire mesh of the intragastric device, is configurable between a
first, compressed configuration for delivery, and a second,
expanded configuration once deployed. The anti-migration component
functions as a physical stopper preventing passage of the
intragastric device through the pylorus. In various embodiments,
the anti-migration component has a diameter that is greater than
the diameter of a relaxed pylorus. In one embodiment, the
anti-migration component comprises an extension of the wire mesh
structure of the intragastric device. In another embodiment, the
anti-migration component is a separate piece of wire mesh which is
attached to a portion of the distal end of the intragastric device.
In various embodiments, the anti-migration component has a shape
approximating a bumper, half-bumper, disc, saucer, or any other
shape which will prevent migration of the device past the
pylorus.
[0110] In other embodiments, a sleeve can be attached to the
intragastric device, where the sleeve extends from the stomach into
the duodenum where it empties, or through the duodenum and into the
jejunum. In one embodiment, the sleeve functions to transit the
sequestered chyme from the wire mesh structure directly to the mid
duodenum or mid-jejunum. In another embodiment, the sleeve is
coupled to the intragastric device but does not directly receive
food from the device. In this embodiment, the proximal end of the
sleeve is distal to the device and receives food directly from
either the stomach or the duodenum. The food entering the sleeve
exits at the distal end, into the duodenum or jejunum, bypassing a
portion of the small intestine.
[0111] The sleeve therefore acts to bypass portions of the
gastrointestinal (GI) tract in order to limit the absorption of
specific materials in the intestine. The benefits provided by a
sleeve are similar to those provided by Roux-en-Y gastric bypass
surgery, namely, weight loss and improvement of type II
diabetes.
[0112] After implantation, the gastrointestinal device of the
present specification, particularly the collar, is in constant
physical contact with the patient's anatomy without being actually
physically attached to the patient's anatomy. This is accomplished
by the sleeve being pulled down by the peristaltic actions of the
small intestine. As the sleeve is pulled down, the collar of the
wire mesh structure contacts the stomach proximal to the pylorus.
The sleeve is constantly in physical contact with the pylorus.
However, this constant contact with the pylorus does not block food
passage. The openings of the wire mesh structure and the lumen of
the sleeve pass food through pylorus without occluding it at any
point, allowing the food to pass into the intestines. The
intragastric device of the present specification physically engages
the gastric emptying region of stomach without fully occluding it
any point. The intragastric device of the present specification
functions as a variable outlet drain and does not act as a stopper
to the passage of food.
[0113] The gastrointestinal device of the present specification is
designed to maximize the amount of food captured and passed through
the sleeve and into the intestines rather than minimizing the
amount of food passing into intestines. By being in constant
contact with the pylorus and stomach, the device is designed to
prevent food from passing around and outside of it. In various
embodiments, at least 10% of the food exiting a patient's stomach
passes through the device and not around the device. In one
embodiment, at least 50% of the food exiting a patient's stomach
passes through the device and not around the device. In various
embodiments, this food that passes into the device and through the
sleeve never comes into contact with the patient's duodenum,
thereby allowing the device to function as a true pyloric
bypass.
[0114] In one embodiment, the device is an inflatable balloon with
an attached sleeve, wherein the balloon is not in fluid
communication with a lumen of the sleeve and the balloon merely
acts to hold the sleeve in position without the need to anchor or
fix the sleeve to the gastrointestinal wall. The balloon can be
inflated or deflated with fluid and is designed to reside in a
person's stomach. The sleeve is flexibly attached to the balloon
and has a proximal opening and a distal opening wherein the
proximal opening is designed to reside proximal to a patient's
ampulla and the distal opening is designed to reside distal to a
patient's ampulla. Partially digested food enters the proximal
opening and exits the distal opening, bypassing the ampullary
region. The sleeve is not anchored or fixed to any portion of the
gastrointestinal wall.
Wire Mesh Structure
[0115] In various embodiments, the intragastric device comprises a
porous three dimensional structure having a pre-deployment shape
and a post-deployment shape. In one embodiment, the device, in the
post-deployment configuration, comprises a three dimensional wire
mesh structure defining an internal volume and having a proximal
end and a distal end.
[0116] In various embodiments, the wire mesh structure includes
free ends or `nodes` comprising bends or curves in the wire of the
wire mesh structure wherein these bends or curves are unsupported
and not connected to any other portion of the wire mesh. In some
embodiments, the wire mesh structure includes two pluralities of
nodes. A first plurality is positioned at the proximal end of the
structure and a second plurality is positioned at the distal end of
the structure. When the wire mesh structure is compressed to its
pre-deployment configuration, the first and second plurality of
nodes at the proximal and distal ends of the structure
respectively, become gathered together or `bunched up`. This
creates a larger cross-sectional area (or diameter) at the proximal
and distal ends of the structure when compared to the
cross-sectional area of the compressed structure between said ends.
As its cross-sectional area becomes larger, the compressed wire
mesh structure becomes increasingly difficult to deploy through a
narrow delivery device or catheter. This delivery problem can be
addressed in at least two different ways. In various embodiments,
the number of nodes in each plurality of nodes is reduced. Reducing
the number of nodes in each plurality makes the structure easier to
compress and creates a smaller cross-sectional area at the ends of
the structure. This reduces the force applied by the compressed
structure to the delivery catheter, thereby making it easier to
pass the compressed structure through the catheter. In various
embodiments, a portion of the nodes from one or both of the first
and second plurality of nodes is moved from said ends of the
structure and positioned along the body of the structure, creating
additional pluralities of nodes. This `staggering` of the nodes
reduces the cross-sectional area of the compressed structure at any
given point and distributes the force applied by the compressed
structure to the delivery catheter, again easing the passage of the
delivery structure through the catheter. In various embodiments,
the number of nodes in each plurality is reduced and the nodes are
staggered in multiple pluralities throughout the structure to
reduce and distribute the force applied by the compressed structure
to the delivery catheter. Reducing and distributing said force
allows for easier delivery and for the use of a delivery catheter
having a smaller diameter. Reduced and distributed forces also
allow for the creation of larger mesh structures that can be
compressed to smaller sizes.
[0117] In various embodiments, each plurality of nodes comprises 10
to 100 individual nodes. In one embodiment, each plurality of nodes
comprises 44 nodes. In another embodiment, each plurality of nodes
comprises 36 nodes. In various embodiments, a wire mesh structure
includes 2 to 60 pluralities of nodes distributed latitudinally at
different locations along its length. In one embodiment, the nodes
are staggered such that at least 10% of the total number of nodes
in the structure are positioned at the proximal and distal ends. In
various embodiments, no more than 75% of the total number of nodes
are positioned in any one plurality of nodes. In various
embodiments, the nodes are distributed within at least three
different lateral pluralities along the length of the
structure.
[0118] The compressibility of the wire mesh structure also depends
on the flexibility of the mesh. The flexibility, in turn, depends
upon, among other variables, the thickness of the wire, the angle
of wire intersections, and the number of wires. Regarding the angle
of wire intersections, as the wires of the structure are arranged
more parallel to one another, the structure becomes more flexible.
In various embodiments, the wire mesh structure, in a
pre-deployment configuration, has an overall length of 5 to 50 cm
and each wire has a thickness in a range of 0.1 to 1 mm. In one
embodiment, each wire has a thickness of 0.44 mm. The wires of the
wire mesh structure have a bending strain which determines how they
behave as the structure is com pressed. In various embodiments, the
wires are comprised of a shape memory metal, such as, in one
embodiment, Nitinol. The shape memory metal has a certain bending
strain percentage beyond which the metal loses its ability to
exactly regain its previous shape. The strain percentage (%) can be
defined by the following formula:
strain %=2t/R.times.100
[0119] wherein t=thickness of the wire and R=radius of the bend. In
one embodiment, once the strain percentage reaches 8%, a permanent
change is introduced to the shape memory metal such that it will no
longer return fully to its original shape. This factor becomes
important as the wire mesh structure is compressed to its
pre-deployment shape for delivery. In various embodiments, the wire
mesh structure includes a collar or circular extension of the wire
mesh at its distal end which functions as an anti-migration
component. This collar must me folded out distally during
compression such that the compressed structure will fit into the
delivery device or catheter. A `bump` in the wire mesh structure is
introduced as the collar is folded out during compression. A strain
percentage of less than 8% creates a smaller bump in the compressed
wire mesh structure, allowing for easier passage of the compressed
structure through a delivery catheter. Therefore, in various
embodiments, the wire mesh structure is configured having a wire
thickness and a bend radius at the collar such that the strain
percentage at the collar will be no more than 20%, and preferably
less than 8%. In various embodiments, the radius of the collar is
less than 10 times the wire thickness. In various embodiments, the
strain percentage is in a range of 0.1 to 20% . In various
embodiments, the wire of the wire mesh has a thickness of 0.1 to
1.0 mm and the collar has a bend radius of 0.013 to 20 cm. In one
embodiment, the wire of the wire mesh has a thickness of 0.4 mm. In
various embodiments, the wire thickness and bend radius are
configured to satisfy the following statement:
2t<R<2000t
[0120] wherein t=thickness of the wire and R=radius of the
bend.
[0121] In various embodiments, the ends of the wire(s) of the wire
mesh structure are terminated in such a way to minimize the
possibility of traumatic injury to body tissues during delivery and
retrieval and while deployed. In some embodiments, the wire mesh
structure comprises a single wire folded into a three dimensional
structure. In other embodiments, the wire mesh structure comprises
more than one wire joined and folded into a three dimensional
structure. In various embodiments, the free ends of the wire or
wires are joined by crimping a titanium tube or Nitinol (or other
shape memory metal) tube over said free ends. In other embodiments,
the free ends of the wire or wires are joined by spot welding said
free ends together. In one embodiment, the intersections of the
wires are not welded. In another embodiment, the intersections of
the wires are welded.
[0122] In one embodiment, the wire mesh structure is enveloped in a
silicone balloon that compresses to a capsule for delivery. After
delivery, the wire mesh structure expands together with the
envelope. The balloon envelope slows down the exposure of the wire
mesh to acid, which corrodes the Nitinol material of the mesh,
thereby prolonging the device life.
Sleeve
[0123] In various embodiments, the intragastric device of the
present specification further comprises a flexible sleeve component
coupled to the wire mesh structure. In multiple embodiments, any of
the wire mesh structures discussed above is coupled with any of the
sleeve components discussed below. The sleeve component comprises
an elongate tubular body having a proximal end and a distal end a
lumen within.
[0124] In one embodiment, the sleeve has a consistent diameter
along its entire length. In other embodiments, the sleeve comprises
a funnel shape proximate its proximal end wherein the diameter of
the sleeve is greatest at the first opening at the proximal end of
the sleeve body and then decreases gradually as it extends distally
until it reaches a minimum diameter at a position proximal to the
midpoint of its length. The diameter then remains constant distally
along the remainder of its length.
[0125] In various embodiments, wherein the wire mesh structure
includes a collar at its distal end, the proximal end of the sleeve
is attached to the bottom surface of said collar by one of the
means listed above. In various embodiments, when the device is
compressed into its pre-deployment configuration, the sleeve body
is pulled upon to assist in folding out the collar. If the proximal
end of the sleeve is attached to the bottom surface of the collar
as described above, the collar is not fully straightened when
folded out, resulting in the creation of a large bulge at the
collar when the device is in the pre-deployment configuration. The
bulge has a large diameter comprising the thickness of the wire
mesh structure and double the thickness of the sleeve. Therefore,
in preferred embodiments, the proximal end of the sleeve is
attached to the free ends, or nodes, of the collar by a plurality
of loose sutures. The sleeve is sutured to each node much similar
to the way in which the fabric of an umbrella is attached to the
end of each spine of the umbrella. When an umbrella is closed, the
fabric collapses down to allow for compression. The intragastric
device of the present specification functions in a similar manner.
In various embodiments, as the wire mesh structure is compressed
for loading onto a delivery device, the distal end of the sleeve is
pulled upon. The loose sutures attaching the sleeve to the nodes of
the wire mesh allow the sleeve to move relative to the wire mesh
such that the collar is pulled distally and extended into a more
linear shape. Such an attachment avoids the creation of a large
bulge at the collar of the pre-deployment configuration. When the
sleeve body is pulled upon during compression, the collar is folded
out more completely and the resultant bulge has a smaller diameter,
comprising only the thickness of the wire mesh structure. In
various embodiments, when the intragastric device is in the
pre-deployment configuration, there is minimum to zero overlap
between the collar and the sleeve. Upon deployment, the shape
memory properties of the wire mesh structure cause the collar to
pull the sleeve onto itself as it expands, much like an umbrella
expanding its fabric as it opens.
[0126] In various embodiments, each node at the distal end of the
wire mesh structure (or collar) is attached to the proximal end of
the sleeve via a suture. This can lead to bulking at the attachment
of the wire mesh structure to the sleeve. Therefore, in other
embodiments, fewer nodes are sutured to the sleeve. For example, in
one embodiment, every other node is sutured to the sleeve to reduce
the number of suture knots and decrease bulking. The inclusion of
glue and multiple loops in each suture knot can also lead to
bulking at the attachment point of the wire mesh structure to the
sleeve. As such, in various embodiments, glue is not used and each
suture knot is limited to one loop. Suturing of the sleeve to the
nodes can lead to sliding of the suture knots along the length of
wire comprising the nodes, resulting in unintended movement of the
sleeve relative to the wire mesh structure. To prevent sliding, in
various embodiments, each suture knot is placed at the first
junctions of the wires proximal to each node. In effect, each
suture is then placed over two wires and cannot slide along one or
the other. To eliminate excessive bulking, in various embodiments,
fewer than every first wire junction is sutured to the sleeve. For
example, in one embodiment, every other first wire junction is
sutured to the sleeve.
[0127] In various embodiments, any sharp ends of wires in the wire
mesh and/or sleeve are crimped and looped onto themselves or looped
outward to act as pulling points for moving the sleeve into the
intestines or for connecting the sleeve to the wire mesh
structure.
[0128] The distal end of the sleeve can be designed to be weighted
so that the sleeve remains in an elongated shape extending through
a portion of the duodenum. In one embodiment, the sleeve includes a
small weight attached to its distal end. In another embodiment,
wherein the second opening at the distal end of the sleeve body is
positioned along the sleeve body at its distal end, the distal end
of the sleeve body further includes a blind pouch. The blind pouch
functions to intermittently trap a small portion of food or fluid
there within. The trapped food or fluid acts to weigh down the
distal end of the sleeve body, thereby keeping the sleeve component
elongated. In one embodiment, the distal end of the sleeve is
reinforced with at least a second layer to assist in keeping the
distal end positioned downward and prevent it from folding up.
[0129] In one embodiment, the sleeve comprises a wire mesh
configuration having a plurality of nodes, similar to the
configuration described above for the wire mesh structure.
[0130] In another embodiment, the sleeve component comprises a
membrane that is flexible and compressible by the contractions of
the small intestine. In one embodiment, the sleeve includes a
minimum level of structure which imparts upon the sleeve a minimum
amount of structural strength to resist buckling from
gastrointestinal forces and remain functional. In one embodiment,
the minimum level of structure comprises a single structure
extending along at least 10% of a length of the sleeve to provide
the sleeve with linear strength. In various embodiments, the single
structure is a straight wire, a wire helix, or a wire mesh. In one
embodiment, the membranous sleeve component comprises a plurality
of horizontal and/or vertical support elements along the length of
the sleeve body. In one embodiment, the horizontal elements include
wire rings spaced apart along the length of the sleeve body. In
various embodiments, the rings are spaced between 2 and 24 inches
apart. In one embodiment, the rings are spaced 6 inches apart. In
one embodiment, the vertical support elements include elongate
metal wires. In various embodiments, the wires are between 2 and 60
inches in length. In one embodiment, the metal wires are 6 inches
in length. In another embodiment, the membranous sleeve component
comprises a spiral metal wire extending along its length. The
spiral metal wire provides support to the sleeve component and
maintains its elongated shape. In various embodiments, the spiral
metal wire is comprised of a shape memory metal, such as Nitinol.
The spiral metal wire must not be too tight such that, once the
sleeve in compressed for delivery, it becomes kinked and cannot
regain its full shape. In various embodiments, the spiral metal
wire of the sleeve has a thickness of 0.1 to 1.0 mm. In one
embodiment, the spiral metal wire of the sleeve has a thickness of
0.2 mm. As similarly discussed above with reference to the collar
bend radius, the bend radius of the spiral metal wire of the sleeve
should be such to create a strain percentage that will be in a
range of 0.1 to 20%, and preferably less than 8%. In various
embodiments, the strain percentage (%) of the spiral metal wire can
be defined by the following formula:
Strain % = d 200 .times. [ 1 Rf - 1 Ri ] ##EQU00001##
[0131] wherein d is the diameter of the wire, Rf is the final bend
radius, and Ri is the initial bend radius. Therefore, in various
embodiments, the spiral metal wire has a pitch in a range of 5 to
150 mm. In one embodiment, the spiral metal wire has a pitch of 60
mm. In various embodiments, the sleeve includes more than one
spiral metal wire to provide greater support while still preventing
permanent kinking. In one embodiment, the sleeve includes three
spiral metal wires wherein each individual wire has a pitch of 60
mm and the wires are spaced such that the pitch between two
separate wires is 20 mm. In another embodiment, the sleeve includes
six spiral or helical wires to provide structural support to the
sleeve. In various embodiments, the membrane of the sleeve
component extends proximally onto the lower portion of the wire
mesh structure and covers all or a portion of said lower
portion.
[0132] The sleeve is flexible and compressible such that during
delivery it is restrained in a compressed configuration on the
distal end of a delivery device. In one embodiment, the sleeve
telescopes into itself to shorten its length and facilitate
delivery. In addition, when the device is in the pre-deployment
configuration, the sleeve can be folded onto itself to shorten its
length and assist with placement in a delivery device or catheter.
In various embodiments, the sleeve is folded 2 to 10 times upon
itself and then folded or wrapped along a delivery device or
catheter for delivery. In one embodiment, the sleeve is fed
coaxially over a guidewire, a delivery device or catheter. In
another embodiment, the sleeve is folded along the side or around a
delivery device or catheter. This helps prevent the sleeve from
sticking to the guidewire and/or delivery device/catheter as the
guidewire and delivery device/catheter are retracted, which is
sometimes encountered when the sleeve has been fed coaxially over
the guidewire or delivery device/catheter.
[0133] In other embodiments, some intragastric devices of the
present embodiment include a sleeve having a shorter length than
the lengths described above. In various embodiments, the short
sleeve has an overall length of 100-120 mm. In various embodiments,
the short sleeve has a funnel shape or cone shape. In some
embodiments, the short sleeve comprises a wire formed into a wire
mesh structure or braid having a plurality of nodes, similar to the
configuration described above for the wire mesh structure. In one
embodiment, the braid is created using a single wire. In one
embodiment, the wire is composed of a shape memory metal. In one
embodiment, the shape memory metal is Nitinol. In other
embodiments, the braid is created by machine braiding multiple
wires. In some embodiments, the pitch, or distance between nodes,
is uniform. In other embodiments, the pitch is variable. The ends
of the braid are designed to be atraumatic. In one embodiment, the
ends are blunted. In another embodiment, the ends are capped with a
soft polymeric tip. In some embodiments, a portion of the short
sleeve is coated with a covering. In some embodiments, the covered
portion comprises the floating nodes. In one embodiment, the
covering is silicone. In various embodiments, the diameter of the
proximal end of the sleeve is approximately equal to the outer
diameter of an anti-migration collar at the distal end of a wire
mesh structure. In such embodiments, the proximal end of the sleeve
is fitted over and attaches to the anti-migration collar. In other
embodiments, the diameter of the proximal end of the sleeve is
smaller than the outer diameter of an anti-migration collar and
approximately equal to the diameter of a neck of the collar
connecting said collar to said wire mesh structure. In these
embodiments, the proximal end of the sleeve is attached to said
neck of said collar.
[0134] In one embodiment, the number of nodes is uniform across the
braid. In one embodiment, the number of nodes is 24. In other
embodiments, the number of nodes is variable across the braid. For
example, in various embodiments, the short sleeve braid includes 24
nodes at the proximal end and 18 or 12 nodes at the distal end. In
these embodiments, the nodes comprising the difference in number of
nodes between the two ends (for example, 6 or 12 nodes) are
floating nodes and are positioned along the body of the short
sleeve.
[0135] Once an intragastric device having a short sleeve is
deployed, the short sleeve intermittently engages and blocks a
patient's pylorus without being anchored to the pylorus. This
prevents food from passing through the pylorus and forces the food
to pass through the short sleeve from the stomach and into the
duodenum, thus regulating gastric outflow. In various embodiments,
an opening at the distal end of the short sleeve is 1-30 mm in
diameter wherein the size of the diameter determines the rate of
gastric outflow. In one embodiment, the opening can be 0 mm when
the pylorus is engaged, thereby completely blocking outflow.
Therefore, food is allowed to enter the duodenum from the stomach
only when the pylorus is not engaged or only partially engaged.
[0136] In various embodiments, the sleeve has a high coefficient of
friction compared to sleeves of the prior art. In various
embodiments, the sleeve has a coefficient of friction ranging from
0.01-0.30. In one embodiment, the sleeve has a coefficient of
friction equal to or less than 0.10. It has been encountered with
relatively smooth sleeves that, during deployment, the smooth
sleeve can become stuck to the inside of a delivery catheter or
stuck to itself, resulting in destruction of the sleeve as force is
applied to free the sleeve. Therefore, a sleeve with a rougher
outer surface can be easier to feed into a delivery device or
catheter and then deploy. In various embodiments, the sleeve
includes a matte outer surface. In other embodiments, a particulate
matter or relatively rough substance, such as corn starch or
biocompatible powder, is applied to the outer surface of the sleeve
prior to loading the sleeve into a delivery device and
deployment.
[0137] In various embodiments, the sleeve includes one or more
radiopaque markers to ensure proper positioning of the sleeve using
radiographic imaging. In various embodiments, the radiopaque
markers include a plurality of individual markings along an outer
surface of the sleeve body. In other embodiments, the radiopaque
marker includes a single line extending along an outer surface of
the sleeve body. A spiraled single line can indicate twisting of
the sleeve. In still other embodiments, the radiopaque markers
include a plurality of individual markings and a single line
extending along an outer surface of the sleeve body. In other
embodiments, no radiopaque markings are necessary as the wire
thickness of the support elements of the sleeve is great enough to
allow for radiographic visualization.
[0138] In another embodiment, the flexible member or sleeve has a
surface optimized for adherence and growth of microorganisms. In
one embodiment, the device comprises a rigid member, such as a
freely floating mesh structure and a flexible member, such as a
freely floating sleeve structure, with surfaces of both the members
designed to promote micro-organism adherence and growth. The
microorganisms produce a desired therapeutic effect including
assistance in weight loss, glycemic control, or treatment of
irritable bowel syndrome, clostridium difficile or any other
condition responsive to a prebiotic or a probiotic therapy.
Retrieval Mechanism
[0139] In various embodiments, the wire mesh structure or wire mesh
structure with coupled sleeve component includes one or more
retrieval mechanisms with at least one retrieval mechanism
positioned proximate the at least one opening at the proximal end
of the wire mesh structure. In one embodiment, the retrieval
mechanism comprises an 80 lb. retrieval suture.
Anti-Migration Component
[0140] In various embodiments, the wire mesh structure or wire mesh
structure with coupled sleeve component includes one or more
anti-migration components or collars.
[0141] In one embodiment, the anti-migration component is comprised
of a metal. In one embodiment, the metal is a shape memory metal,
such as Nitinol. The anti-migration component is preferably
positioned at the distal end of the wire mesh structure (at the
junction of the wire mesh structure with the sleeve component in
the embodiment of the device including a sleeve) and, once the
device is deployed, comes to rest proximal to the pylorus. The
anti-migration component functions to prevent passage of the wire
mesh structure or entire device through the pylorus.
[0142] In various embodiments, various components of the device,
including the wire mesh structure, retrieval mechanism, and/or
anti-migration component are coated with a therapeutic drug to
enhance functionality of the device.
[0143] In various embodiments, the wire mesh structure, hook,
and/or anti-migration component include a radiopaque marker for
radiographic visualization to facilitate delivery and retrieval. In
various embodiments, the wire mesh structure, hook, and/or
anti-migration component include an ultrasound marker for
ultrasound visualization to facilitate delivery and retrieval.
Delivery Device
[0144] The present specification also discloses various embodiments
of a delivery device used to deploy an intragastric device in the
gastrointestinal tract of a patient. An intragastric device is
preloaded onto a delivery device which is then used to deliver the
wire mesh of the intragastric device into the stomach and the
sleeve of the intragastric device into the proximal small
intestine.
[0145] In one embodiment, a delivery device comprises an elongate
tubular body having a coaxial plunger and catheter and a plurality
of handles. The handles are manipulated to deploy the sleeve and
wire mesh structure of the intragastric device in multiple stages.
In one embodiment, the tubular body includes a trigger which
controls movement of the various components of the delivery device
to effectuate intragastric device deployment.
[0146] In various embodiments, the intragastric device can be
retrieved using a standard overtube, endoscope, and grasper.
[0147] The present invention is directed towards multiple
embodiments. The following disclosure is provided in order to
enable a person having ordinary skill in the art to practice the
invention. Language used in this specification should not be
interpreted as a general disavowal of any one specific embodiment
or used to limit the claims beyond the meaning of the terms used
therein. The general principles defined herein may be applied to
other embodiments and applications without departing from the
spirit and scope of the invention. Also, the terminology and
phraseology used is for the purpose of describing exemplary
embodiments and should not be considered limiting. Thus, the
present invention is to be accorded the widest scope encompassing
numerous alternatives, modifications and equivalents consistent
with the principles and features disclosed. For purpose of clarity,
details relating to technical material that is known in the
technical fields related to the invention have not been described
in detail so as not to unnecessarily obscure the present
invention.
[0148] FIG. 1 is an illustration of an upper gastrointestinal
system. After swallowing, food passes rapidly through the esophagus
111 into the stomach 112. There, it is digested for a period of
time and undergoes the process of dilution to an iso-osmotic
concentration by grinding and mixing with gastric juices. The
stomach 112 relaxes to accommodate the volume of ingested food. As
the stomach 112 gets filled with food the sensation of fullness or
satiety is generated by stretch receptors in the gastric wall and
the person stops eating. The iso-osmotic food, known as chyme, then
passes through the pylorus 113 into the duodenum 114. Passage of
chyme into the duodenum 114 results in the release of enzyme rich
pancreatic secretions from the pancreas 115 and bile salt rich
biliary secretions from the liver 116. The biliary secretions
travel through the common bile duct 117 where they combine with the
pancreatic secretions arriving through the pancreatic duct 118 and
the two ducts combine to form the ampulla of vater 119. The ampulla
of vater 119 serves as the entry point for the secretions to be
deposited into the duodenum 114. In the jejunum 120, the mixing of
pancreatic and biliary secretions with the chyme results in the
digestion of proteins, fats, and carbohydrates, which are then
absorbed into the blood stream.
[0149] FIG. 2A is an illustration of a wire mesh structure 201 of
an intragastric device in a post-deployment configuration with a
proximally sloping anti-migration disc or collar 204 extending from
or attached to its distal end, in accordance with one embodiment of
the present specification. The wire mesh structure 201 comprises a
three dimensional porous structure having an internal volume. The
wire mesh structure 201 has an oval shape and includes a retrieval
mechanism 203. In one embodiment, the retrieval mechanism is a silk
suture loop. In one embodiment, the retrieval mechanism is an 80
lb. retrieval suture. The anti-migration collar 204 is proximally
sloping in that it comprises a distal portion of the wire mesh
structure 201 that is folded such that the distally directed end of
the wire mesh structure 201 is made to point toward the proximal
end of the wire mesh structure 201. In other embodiments, the
collar 204 comprises any curved/atraumatic structure positioned
circumferentially around the distal end of the wire mesh structure
201. The collar 204 helps prevent the wire mesh structure 201 from
entering and passing through the pylorus. In one embodiment, the
wire mesh structure 201 includes a bulbous, predominantly spherical
or ovoid proximal end and an expanded distal end. In one
embodiment, the distal half of the structure is covered with a
membrane to impede the passage of food out of the structure 201,
directing the food through a distal opening. In one embodiment, the
structure 201 has an optional anti-reflux valve at the proximal end
and another optional valve at the distal end. The valve at the
distal end acts to control the flow of chyme or partially digested
food from the inside of the structure 201 to the outside of the
structure 201.
[0150] FIG. 2B is an illustration of a wire mesh structure 210 in a
post-deployment configuration with a proximally curving
anti-migration collar 214 formed at its distal end, in accordance
with one embodiment of the present specification. The wire mesh
structure 210 has an oval shape with a proximal end and a distal
end. The wire mesh structure 210 includes staggered nodes 216, 218
within its body to facilitate compression for delivery and removal.
The wire mesh structure 210 also includes a set of staggered nodes
217 at its proximal end. The staggered nodes 217 at the proximal
end provide a location for grasping, thereby enhancing ease of
retrieval. The anti-migration collar 214 is formed from a
continuation of the wire of the wire mesh structure 210 at its
distal end. The anti-migration collar 214 bends proximally, toward
the body of the wire mesh structure 210, and its ends 215 are
formed in a rounded fashion to be atraumatic to body tissues. In
various embodiments, the wire mesh structure 210 has no sharp
edges, preventing the occurrence of abrasions, and a radial force
high enough to prevent any significant or permanent deformation by
gastric contractions and passage through the pylorus, but low
enough such that the wire mesh structure 210 is not too rigid,
allowing it to be affected by gastric contractions enough to
facilitate movement of food through the wire mesh structure 210. In
some embodiments, the wire mesh structure can withstand a
contractile force up to 200 mm Hg without being completely com
pressed.
[0151] FIG. 3A is a close-up illustration of an atraumatic
anti-migration collar 314 of a wire mesh structure 310 of an
intragastric device 300, in accordance with one embodiment of the
present specification. The anti-migration collar 314 has a toroid
bulb shape and comprises rounded ends 315 which extend proximally
toward the wire mesh structure 310. The rounded ends 315 are
designed to be atraumatic to body tissues. As discussed above, in
some embodiments, the ends 315 are separated into various nodes to
prevent bunching of the wires when compressed, which could lead to
erosions. The long axis of the collar 312 is curved at an angle 313
greater than 90.degree. compared to the long axis of the mesh 311
such that the rounded ends 315 are pointing in the direction toward
the wire mesh structure 310.
[0152] FIG. 3B is a close-up illustration of an atraumatic
anti-migration collar 324 of a wire mesh structure 321 of an
intragastric device 320, in accordance with another embodiment of
the present specification. The anti-migration collar 324 has a
toroid bulb shape and comprises rounded ends 325 which extend
proximally toward the wire mesh structure 321. The rounded ends 325
are designed to be atraumatic to body tissues. In some embodiments,
the ends 325 are separated into various nodes 327l, 327s to prevent
bunching of the wires when compressed, which could lead to
erosions. The nodes include long nodes 327l and short nodes 327s,
wherein the long nodes 327l extend further in a proximal direction
back toward the top of the wire mesh structure 321 than the short
nodes 327s. In some embodiments, the collar 324 includes 9 long
nodes 327l and 9 short nodes 327s. The free ends of the long nodes
327l include hoops 328 for suturing a proximal end of a sleeve
component. The hoops 328 extend outward away from the free ends of
the long nodes 327l. In one embodiment as shown in FIG. 3C, hoops
328a are formed from twisting the free ends of the long nodes 327l
into a hoop shape. In another embodiment as shown in FIG. 3D, hoops
328b comprise separate wire hoops that are sutured to the free ends
of the long nodes 327l. In some embodiments, once the sleeve is
attached, additional suture knots are placed at the junction of the
twist or separate wire hoop to prevent sliding of the sleeve
attachment.
[0153] In some embodiments, a sleeve component is attached to the
distal end of the wire mesh structure or the collar of the
intragastric device. In various embodiments, the sleeve component
of the present specification is made of polytetrafluoroethylene
(PTFE) or polyethylene or cast PTFE (e.g., Teflon), PTFE with
fluorinated ethylene propylene (FEP) or perfluoroalkoxy (PFA)
coating, PFA, extruded FEP and extruded PFA or extruded PTFE or a
fluoropolymer or silicone. In one embodiment, a silicone sleeve is
manufactured by hand pouring and braiding. In another embodiment, a
silicone sleeve is manufactured by machine braiding. In various
embodiments, the sleeve component has a length in a range of 6
inches to 6 feet or longer. In one embodiment, the sleeve component
has a length of 24 inches. In another embodiment, the sleeve
component has a length of 30 inches. In various embodiments, the
sleeve component has a diameter in a range of 1 cm to 10 cm. In one
embodiment, the sleeve component has a diameter of 3 cm.
[0154] FIG. 4A is an illustration of a portion of a sleeve
component 400 of an intragastric device in a post-deployment
configuration in accordance with one embodiment of the present
specification, depicting a single wire support 401 spiraling along
the body of the sleeve 400. The metal wire needs to have a tight
enough spiral to provide support but must not be too tight such
that, once the sleeve in compressed for delivery, it becomes kinked
and cannot regain its full shape. Referring to FIG. 4A, the spiral
metal wire 401 has a pitch depicted by length l which is equal to
60 mm. With a wire thickness of 0.1 to 1 mm, this pitch gives the
spiral metal wire a strain percentage that will be no more than
20%, and preferably less than 8%.
[0155] FIG. 4B is an illustration of a portion of a sleeve
component 405 of an intragastric device in a post-deployment
configuration in accordance with one embodiment of the present
specification, depicting multiple wire supports 406, 407, 408
spiraling along the body of the sleeve 405. The sleeve includes
more than one spiral metal wire to provide greater support while
still preventing permanent kinking. Referring to FIG. 4B, each
individual wire 406, 407, 408 has a pitch depicted by length
l.sub.1 which is equal to 60 mm. The wires 406, 407, 408 are spaced
such that the pitch between two separate wires, depicted by length
l.sub.2, is equal to 20 mm.
[0156] FIG. 4C is an illustration of a funnel shaped sleeve
component 410 of an intragastric device in a post-deployment
configuration in accordance with one embodiment of the present
specification, depicting spiral wire loop supports 411, 413 on the
sleeve 410. In the embodiment depicted in FIG. 4C, the sleeve 410
includes two sets of wire loop supports 411, 413. Each set of wire
loop supports 411, 413 includes a loop comprising two individual
wires, for a total of four wires on the sleeve 410. Each wire loop
support 411, 413 is finished with blunted ends 415 to be atraumatic
to body tissues. The wire loop supports 411, 413 are twisted into a
spiral configuration and looped along the length of the sleeve 410.
In one embodiment, the pitch, or distance between each loop 411,
413 (and between each wire of each loop 411, 413) is defined by
length l and is approximately 15 mm.
[0157] In one embodiment, the opening of the funnel shaped sleeve
is well suited for attachment to the nodes of the collar positioned
at the distal end of the wire mesh structure of some embodiments of
the intragastric device.
[0158] FIG. 5 is an illustration of a wire mesh structure 530 with
attached sleeve component 544 in a post-deployment configuration in
accordance with one embodiment of the present specification,
depicting a blunt end 552 of a wire mesh support toward the
proximal end of the sleeve 544. The sleeve 544 is connected to a
proximally curving, atraumatic anti-migration collar 542 at the
distal end of the wire mesh structure 530 and includes a proximal
section 545 having four layers and a center section 555 having
three layers.
[0159] FIG. 6 is an illustration of an intragastric device 600 with
a funnel shaped sleeve 610 in a post-deployment configuration, in
accordance with one embodiment of the present specification. The
intragastric device 600 includes a wire mesh structure 605 having a
proximal end and a distal end with an anti-migration collar 620
formed at said distal end. The sleeve 610 includes a proximal end
and a distal end and is attached via its proximal end to the
anti-migration collar 620.
[0160] The wire mesh structure 605 comprises at least one metal
wire folded about itself to create a crisscross weave pattern with
a plurality of free curved ends, or nodes, along the structure. In
its expanded, post-deployment configuration, the wire mesh
structure 605 has an oval shape. To facilitate optimal expansion
and compression for easier delivery and removal, the wire mesh
structure 605 includes a plurality of staggered nodes 606, 607,
608, 609 along its length. A first set of staggered nodes 606 is
positioned at the proximal end of the wire mesh structure 605 and
circumscribes a first opening 601. In one embodiment, each node in
said first set of staggered nodes 606 is bent upwards to extend in
a direction opposite from an interior of the wire mesh structure
605. The nodes in said first set of staggered nodes 606 are used as
grasping points for a retrieval device during removal of the
intragastric device 600. The wire mesh structure 605 includes a
second set of staggered nodes 607 distal to said first set 606 and
proximal to a midpoint of said wire mesh structure 605. A third set
of staggered nodes 608 is positioned distal to said midpoint and
proximal to the distal end of the wire mesh structure 605. A fourth
set of staggered nodes 609 is positioned at the distal end of the
wire mesh structure 605 and comprises the free end of the
anti-migration component 620. All of the curves comprising the
nodes in each set of staggered nodes 606, 607, 608, 609 are
designed to have a bend that is atraumatic to body tissues. The
nodes are staggered to prevent bunching of the bending points of
the wire and bulking of the wire mesh structure as it is compressed
to its pre-deployment configuration. Spreading the nodes along the
length of the wire mesh structure allows for an overall smaller
diameter of the device once it is compressed.
[0161] The sleeve 610 includes a proximal portion 611 and a distal
portion 616 which join at a transition point 615 along the sleeve
610 body. Both the proximal portion 611 and the distal portion 616
of the sleeve 610 are funnel shaped, each having a diameter that
decreases as the portions 611, 616 extend distally. In one
embodiment, the diameter of the proximal portion 611 is
substantially the same as the diameter of the anti-migration collar
620 at a proximal end of said proximal portion 611. The diameter of
the proximal portion 611 decreases as the proximal portion 611
extends distally until the sleeve 610 transitions into its distal
portion 616, at which point the diameters of the proximal portion
611 and the distal portion 616 are equal. The diameter of the
distal portion 616 then decreases as said distal portion 616
extends distally. The distal portion 616 of the sleeve 610 ends in
a second opening 619 at a distal end of the intragastric device
600. In one embodiment, the proximal portion 611 has a length that
is less than a length of the distal portion 616. In various
embodiments, the funnel shaped sleeve 610 comprises at least one
wire support. In some embodiments, the at least one wire support
comprises the same wire(s) in both the proximal portion 611 and
distal portion 616. In other embodiments, the proximal portion 611
and distal portion 616 comprise separate wire supports and the
wires are joined together at a distal end of the proximal portion
611 and a proximal end of the distal portion 616. In one
embodiment, the separate wires are spot welded together. The wire
is folded upon itself to create a crisscross weave pattern in the
sleeve 610. In both the proximal 611 and distal portions 616, the
intersecting sections of the wire come closer to one another as the
portions 611, 616 extend distally and the funnel shape narrows,
such that the weave pattern becomes tighter at the distal ends of
each portion 611, 616. The sleeve 610 includes curves or free ends,
similar to the nodes of the wire mesh structure 605, at its
proximal end and distal end. The free ends are designed to be
atraumatic to body tissues. The free ends at the proximal end of
the sleeve 610 are attached to the nodes of the fourth set of
staggered nodes 609 of the wire mesh structure 605 via one or more
sutures 622. The free ends at the distal end of the sleeve 610
circumscribe the second opening 619. In various embodiments, the
sleeve 610 is a short sleeve having a total length in a range of 5
cm-120 cm. In one embodiment, the sleeve 610 is a short sleeve
having a total length of 60 cm. In one embodiment, the sleeve 610
includes a soft atraumatic tip 630 at its distal end. The tip 630
contains no wires and is included to prevent injury to the
intestinal mucosa from the sleeve tip.
[0162] When the sleeve 610 is attached to the wire mesh structure
605, the proximal end of the proximal portion 611 of the sleeve 610
is slid over and covers at least a portion of the anti-migration
component 620 such that the proximal portion 611 of the sleeve 610
covers an opening at the distal end of the wire mesh structure.
This positioning enables fluid communication between the interior
of the wire mesh structure 605 and an interior of the sleeve 610
and establishes a pathway for food from said first opening 601,
into said interior of said wire mesh structure 605, through said
interior of said sleeve 610, and out of said second opening
619.
[0163] FIG. 7 is an illustration of an intragastric device 700 with
a cylindrically shaped sleeve 710 in a post-deployment
configuration, in accordance with one embodiment of the present
specification. The intragastric device 700 includes a wire mesh
structure 705 having a proximal end and a distal end with an
anti-migration collar 720 formed at said distal end. The sleeve 710
includes a proximal end and a distal end and is attached via its
proximal end to the anti-migration collar 720. In one embodiment,
the sleeve 710 includes a soft atraumatic tip 730 at its distal
end. The tip 730 contains no wires and is included to prevent
injury to the intestinal mucosa from the sleeve tip.
[0164] The wire mesh structure 705 is similar to the structure 605
discussed with reference to FIG. 6 and includes an oval shape with
a crisscross weave pattern, a plurality of staggered nodes 706,
707, 708, 709, and a first opening 701 at its proximal end. All of
the curves comprising the nodes in each set of staggered nodes 706,
707, 708, 709 are designed to have a bend that is atraumatic to
body tissues.
[0165] The sleeve 710 includes a proximal portion 711 and a distal
portion 716 which join at a transition point 715 along the sleeve
710 body. The proximal portion 711 of the sleeve 710 is funnel
shaped and includes a diameter that decreases as the portion 711
extends distally. In one embodiment, the diameter of the proximal
portion 711 is substantially the same as the diameter of the
anti-migration collar 720 at a proximal end of said proximal
portion 711. The diameter of the proximal portion 711 decreases as
the proximal portion 711 extends distally until the sleeve 710
transitions into its distal portion 716, at which point the
diameters of the proximal portion 711 and the distal portion 716
are equal. The diameter of the distal portion 716 then continues at
the same size as said distal portion 716 extends distally, giving
the distal portion 716 a substantially cylindrical shape. The
distal portion 716 of the sleeve 710 ends in a second opening 719
at a distal end of the intragastric device 700. In one embodiment,
the proximal portion 711 has a length that is less than a length of
the distal portion 716.
[0166] In various embodiments, the funnel shaped proximal portion
711 of the sleeve 710 comprises at least one wire support. The wire
is folded upon itself to create a crisscross weave pattern in the
sleeve 710. The intersecting sections of the wire come closer to
one another as the portion 711 extends distally and the funnel
shape narrows, such that the weave pattern becomes tighter at the
distal end of the proximal portion 711. In various embodiments, the
distal portion 716 includes at least one helical wire support
extending along its cylindrical length. The helical wire support
has a consistent pitch such that a resultant helical weave
structure has the same pattern along the length of the distal
portion 716 of the sleeve 710. In some embodiments, the helical
wire support of the distal portion 716 is an extension of the at
least one wire support of the proximal portion 711. In other
embodiments, the proximal portion 711 and distal portion 716
comprise separate wire supports and the wires are joined together
at a distal end of the proximal portion 711 and a proximal end of
the distal portion 716. In one embodiment, the separate wires are
spot welded together. The sleeve 710 includes curves or free ends,
similar to the nodes of the wire mesh structure 705, at its
proximal end and distal end. The free ends are designed to be
atraumatic to body tissues. The free ends at the proximal end of
the sleeve 710 are attached to the nodes of the fourth set of
staggered nodes 709 of the wire mesh structure 705 via one or more
sutures 722. The free ends at the distal end of the sleeve 710
circumscribe the second opening 719. In various embodiments, the
sleeve 710 is a short sleeve having a total length in a range of 5
cm-120 cm. In one embodiment, the sleeve 710 is a short sleeve
having a total length of 60 cm. The funnel shaped conical section
can vary from being 1% of the total sleeve length to being 100% of
the total sleeve length.
[0167] When the sleeve 710 is attached to the wire mesh structure
705, the proximal end of the proximal portion 711 of the sleeve 710
is slid over the anti-migration component 720 such that the
proximal portion 711 of the sleeve 710 covers an opening at the
distal end of the wire mesh structure. This positioning enables
fluid communication between the interior of the wire mesh structure
705 and an interior of the sleeve 710 and establishes a pathway for
food from said first opening 701, into said interior of said wire
mesh structure 705, through said interior of said sleeve 710, and
out said second opening 719.
[0168] FIG. 8A is a close-up illustration of a funnel shaped sleeve
802 attached to an anti-migration collar 804 of a wire mesh
structure 805 of an intragastric device 800, in accordance with one
embodiment of the present specification. The sleeve 802 is attached
to the anti-migration collar 804 via a plurality of sutures 808.
FIG. 8B is a close-up illustration of a funnel shaped sleeve 812
attached to an anti-migration collar 814 of a wire mesh structure
815 of an intragastric device 810, in accordance with another
embodiment of the present specification. The sleeve 812, attached
to the anti-migration collar 814 via a plurality of sutures 818,
includes a plurality of frayed edges 811 at its proximal end to
make said edges less traumatic to body tissues.
[0169] FIG. 8C is an illustration of an intragastric device 820
comprising a wire mesh structure 825 and attached sleeve 822, in
accordance with one embodiment of the present specification. The
wire mesh structure 825 is anchorless and includes atraumatic wire
ends. In one embodiment, the wire mesh structure 825 is composed of
Nitinol. The wire mesh structure 825 includes an anti-migration
collar 824 to which the sleeve 822 is attached. In some
embodiments, the wire mesh structure 825 includes retrieval
drawstrings positioned proximate its proximal end, as depicted with
reference to FIG. 8E. The sleeve 822 comprises an anchorless,
impermeable, fluoropolymer liner designed to extend into the
proximal portion of the small bowel, particularly the mid-duodenum.
In various embodiments, the sleeve 822 includes an embedded Nitinol
stent structure within polymer layers such that the sleeve 822 is
atraumatic and no portion of the Nitinol comes into contact with
the small intestine. In one embodiment, the sleeve 822 includes
radiopaque markers for assistance with proper delivery and
placement.
[0170] The wire mesh structure 825 is anchorless and occupies a
space within the stomach. The wire mesh structure 825 is free to
float within the stomach and intermittently exerts gentle,
atraumatic stretching forces on a portion of the stomach as it
comes into contact with the inner stomach wall. The stretching
forces induce the sensation of satiety in the patient. The
anti-migration collar 824 is appropriately shaped to receive the
attached sleeve 822. Gastric contents enter the wire mesh structure
825 through a first opening 821 at the proximal end of the wire
mesh structure 825 or through openings 829 between the wires of the
wire mesh structure 825 and are directed into the attached sleeve
822. The gastric contents then pass through the sleeve 822 and
empty out a second opening 823 at the distal end of the sleeve 822,
either into the duodenum or jejunum, depending on the length of the
sleeve 822. The sleeve 822 is pre-attached to the anti-migration
collar 824 of the wire mesh structure 825. The Nitinol stent
structure embedded in the sleeve 822 provides support to the sleeve
822 and prevents it from torsion or being kinked by actions of the
intestinal musculature. Additionally, the Nitinol stent structure
provides a gentle, radial stretching force on the small intestinal
wall, inducing a sensation of satiety in the patient and preventing
the passage of chyme around the sleeve 822.
[0171] FIG. 8D is an illustration of the intragastric device 820 of
FIG. 8C with the sleeve 822 straightened to depict the device 820
dimensions relative to the surrounding anatomy. The sleeve 822
includes a proximal, funnel or cone shaped portion 822p attached to
the anti-migration collar of the wire mesh structure 825 and a
distal, cylindrically shaped portion 822d extending distally from
said proximal portion 822p. The wire mesh structure 825 and
proximal portion 822p of the sleeve 822 are configured to reside in
the stomach of the patient and together have a maximum outer
diameter of approximately 8 inches and a length l.sub.1. In some
embodiments, length l.sub.1 is approximately 10 inches. In some
embodiments, the volume of a fully deployed wire mesh structure 825
is approximately 1 liter. The proximal portion 822p of the sleeve
822 and the distal portion 822d of the sleeve 820 meet at a
junction point 822j which is configured to sit at the patient's
pylorus. The distal portion 822d of the sleeve 820 is configured to
reside in the small intestine of the patient, particularly the
duodenum, and has a maximum outer diameter of approximately 1.0
inches and a length l.sub.2. In some embodiments, length l.sub.2 is
approximately 10 to 25 inches. In some embodiments, the length
l.sub.2 of the distal portion 822d is such that the distal end of
the sleeve 822 is positioned in the duodenum so gastric contents
pass from the stomach, through the device 820, and directly into
the duodenum, bypassing the pylorus. In other embodiments, the
length l.sub.2 is such that the distal end of the sleeve 822 is
positioned in the jejunum so gastric contents pass from the
stomach, through the device 820, and directly into the jejunum,
bypassing the pylorus and duodenum. In other embodiments, the wire
mesh structure has a maximum diameter of 18 inches, a maximum
length of 24 inches, and a maximum volume of 2.5 liters.
[0172] FIG. 8E is an illustration of a wire mesh structure 835 and
sleeve 832 of an intragastric device 830, depicting retrieval
drawstrings 837, 838 on said wire mesh structure 835, in accordance
with one embodiment of the present specification. The sleeve 832 is
attached to an anti-migration collar 834 at the distal end of the
wire mesh structure 835. In some embodiments, the anti-migration
collar 834 includes loops in the wires of the nodes at the distal
end of the nodes, as seen with reference to FIG. 4C, and the sleeve
832 is sutured to the anti-migration collar 834 at these loops. In
the pictured embodiment, a pair of retrieval drawstrings 837, 838
are located on the wire mesh structure 835 proximate its proximal
end. A first drawstring 837 is positioned at the proximal end of
the wire mesh structure 835 and the second drawstring 838 is
positioned distal to the first drawstring 837 but still proximate
the proximal end of the wire mesh structure 835. The retrieval
drawstrings 837, 838 pass through the openings between the wires of
the wire mesh structure 835. During retrieval, free ends of the
retrieval drawstrings 837, 838 are pulled on using a grasper to
constrict the wire mesh structure 835 to a smaller outer diameter
so it may be removed from the patient through an endoscope. In one
embodiment, the two drawstrings 837, 838 are interconnected
operably such that constricting one drawstring results in the other
drawstring constricting simultaneously.
[0173] FIG. 8F is an illustration of a wire mesh structure 845 and
sleeve 842 of an intragastric device 840, depicting a single
retrieval drawstring 848 on said wire mesh structure 845, in
accordance with one embodiment of the present specification. The
sleeve 842 is attached to an anti-migration collar 844 at the
distal end of the wire mesh structure 845. In some embodiments, the
anti-migration collar 844 includes loops in the wires of the nodes
at the distal end of the nodes, and the sleeve 842 is sutured to
the anti-migration collar 844 at these loops. In the pictured
embodiment, a single retrieval drawstring 848 is located on the
wire mesh structure 845 proximate its proximal end. The retrieval
drawstrings 848 passes through the openings between the wires of
the wire mesh structure 845. During retrieval, free ends of the
retrieval drawstring 848 are pulled on using a grasper to constrict
the wire mesh structure 845 to a smaller outer diameter so it may
be removed from the patient through an endoscope. In the pictured
embodiment, the single drawstring 848 is sufficient to constrict
two pluralities of nodes 847, 849 on the wire mesh structure 845, a
first plurality 847 at the proximal end of the wire mesh structure
845 and a second plurality 849 at the level of the drawstring 848.
In other embodiments, a single drawstring is sufficient for
constricting one or more than two pluralities of nodes on the wire
mesh structure.
[0174] In some embodiments, wherein the sleeve includes metal wire
supports, the ends of the wire or wires are designed to be
atraumatic to body tissues. In various embodiments, the wire ends
are blunted, folded upon the wire, or welded to other wire ends. In
other embodiments, the distal end of the sleeve includes a
component designed to make said distal end atraumatic to body
tissues. FIG. 9A is a cross-sectional illustration of a distal end
of a sleeve 905, depicting one embodiment of a component 910
designed to configure said distal end to be atraumatic to body
tissues. The component 910 has a cylindrical shape with a proximal
end 911, a distal end 919, and a lumen 916 within. The component
910 is open at both ends 911, 919. The lumen 916 of the component
910 is in fluid communication with a lumen 906 of the sleeve 905 to
allow for food to pass through the wire mesh of the device, the
sleeve 905, and the component 910. The distal end 919 is rounded
into a blunt shape that is atraumatic to body tissues. An outer
surface of the component 910 includes a groove 913 configured to
receive a circular member or O-ring 914. To attach the component
910 to the sleeve 905, the distal end of the sleeve 905 is
coaxially slid onto the proximal end 911 of the component 910 such
that a portion of the sleeve 905 is positioned over said groove
913. The O-ring 914 is then placed over the sleeve 905 and into the
groove 913, providing a robust connection of the sleeve 905 to the
component 910. The distal sleeve end 907 is then folded in a
proximal direction back toward the sleeve 905 body.
[0175] In one embodiment, the component 910 includes a circular
flange 912 which extends outwardly from the outer surface of the
component 910 and then in a proximal direction. The flange 912
serves to cover any sharp ends present in the folded distal sleeve
end 907 and further protect body tissues from trauma. In various
embodiments, the component 910 has a length in a range of 5 mm to
500 mm, an outside diameter in a range of 3 mm to 30 mm, and an
inside diameter in a range of 0.5 to 50 mm.
[0176] FIG. 9B is a cross-sectional illustration of a distal end of
a sleeve 905, depicting another embodiment of a component 920
designed to configure said distal end to be atraumatic to body
tissues. The component 920 has a cylindrical shape with a proximal
end 921, a distal end 929, and a lumen 926 within. The component
920 is open at both ends 921, 929. The lumen 926 of the component
920 is in fluid communication with a lumen 906 of the sleeve 905 to
allow for food to pass through the wire mesh of the device, the
sleeve 905, and the component 920. The distal end 929 is rounded
into a blunt shape that is atraumatic to body tissues. An outer
surface of the component 920 includes a groove 923 configured to
receive a circular member or O-ring 924. To attach the component
920 to the sleeve 905, the distal end of the sleeve 905 is
coaxially slid onto the proximal end 921 of the component 920 such
that a portion of the sleeve 905 is positioned over said groove
923. The O-ring 924 is placed over the sleeve 905 and into the
groove 923. The distal sleeve end is then folded in a proximal
direction back toward the sleeve 905 body. A heat shrink tube 925
is then placed over said distal sleeve end and said O-ring 924.
Heat is applied to the heat shrink tube 925 to shrink the tube 925
such that it securely connects the sleeve 905 to the component 920.
Any sharp ends in the distal sleeve end are contained under the
heat shrink tube 925 and are not exposed to body tissues.
[0177] FIG. 9C is a cross-sectional illustration of a distal end of
a sleeve 905, depicting another embodiment of a component 930
designed to configure said distal end to be atraumatic to body
tissues. The component 930 has a cylindrical shape with a proximal
end 931, a distal end 939, and a lumen 936 within. The component
930 is open at both ends 931, 939. The lumen 936 of the component
930 is in fluid communication with a lumen 906 of the sleeve 905 to
allow for food to pass through the wire mesh of the device, the
sleeve 905, and the component 930. The distal end 939 is rounded
into a blunt shape that is atraumatic to body tissues. An outer
surface of the component 930 includes a groove 933 configured to
receive a circular member or O-ring 934. To attach the component
930 to the sleeve 905, the sleeve 905 is first everted to be inside
out. The distal end of the sleeve 905 is then coaxially slid onto
the distal end 939 of the component 930 such that a portion of the
sleeve 905 is positioned over said groove 933. The O-ring 934 is
placed over the sleeve 905 and into the groove 933. The sleeve 905
is then folded in a proximal direction back over the O-ring 934 and
proximal end 931 of the component 930, providing a robust
connection of the sleeve 905 to the component 930. This process of
connecting the sleeve 905 to the component 930 ensures that the
distal sleeve end 907 will become positioned within the sleeve
lumen 906. Any sharp ends in the distal sleeve end 907 are
contained within the sleeve lumen 906 and are not exposed to body
tissues.
[0178] FIG. 10 is an illustration of a distal end of a sleeve 1005
with a positioning tail 1010 attached thereto, in accordance with
one embodiment of the present specification. The positioning tail
1010 is attached to the distal end of a short sleeve 1005 having a
length of 5 mm to 500 mm. The positioning tail 1010 comprises a
ribbon of material extending from the distal end of the sleeve 1005
into a patient's duodenum and is used to help maintain proper
implant orientation of the sleeve 1005 relative to a patient's
pylorus. In various embodiments, the positioning tail 1010 has a
length l in a range of 5 mm to 500 mm. In one embodiment, the
positioning tail 1010 has a length l of 25 mm. In one embodiment,
the distal end of the positioning tail 1010 includes a bead 1015
for weighing down said distal end. In another embodiment, the
distal end of the positioning tail includes a plurality of separate
free ends similar to a horse tail. In other embodiments, the distal
end of the positioning tail includes any mechanism or component
designed to provide additional weight or tugging upon said distal
end to allow for pulling on said tail to ensure proper sleeve
orientation. In one embodiment, the distal end of the positioning
tail does not include any additional components.
[0179] FIG. 11A is an illustration of a distal end of a sleeve 1110
comprising a plurality of fringes 1112 joined to a ball 1113, in
accordance with one embodiment of the present specification. In
various embodiments, the distal end of the sleeve 1110 comprises
two or more fringes 1112. In one embodiment, the distal end of the
sleeve 1110 comprises four fringes 1112. Each fringe 1112 comprises
a portion of sleeve material which is separate from adjacent
fringes 1112. The fringes 1112 are separated from one another by a
space 1111 which allows food passing through the intragastric
device to exit from the sleeve 1110. In various embodiments, each
fringe 1112 has a length in a range of 5 mm to 500 mm and a width
in a range of 1 mm to 15 mm. In some embodiments, the width of each
fringe 1112 decreases as the fringe 1112 extends distally. The
fringes 1112 are connected to a ball 1113 at the most distal end of
the sleeve 1110. In various embodiments, the ball 1113 has a
diameter in a range of 2 mm to 30 mm. In various embodiments, the
ball 1113 is glued or bonded to each fringe 1107. The ball 1113
serves to join the fringes 1112 together and to weigh down the
distal end of the sleeve 1110 to assist with proper device
orientation. Since the ball 1113 has a spherical shape, it has no
sharp edges and is atraumatic to body tissues. In another
embodiment, the most distal ends of the fringes 1112 are tied
together into a knot to form the ball 1113 and no additional ball
component is required. In some embodiments, the fringes 1112 and
ball 1113 are parachute shaped. In one embodiment, the
circumference of the ball is designed to sit inside an outer
catheter of a delivery device.
[0180] FIG. 11B is an illustration of a distal end of a sleeve 1120
having at least one suture 1122 with attached suture loop or bead
1123 extending therefrom, in accordance with one embodiment of the
present specification. In one embodiment, the sleeve 1120 includes
six sutures 1122. In various embodiments, the sutures 1122 have a
length in a range of 5 mm to 500 mm. In one embodiment, the sutures
1122 are composed of UHMWPE. A proximal end of each suture 1122 is
attached to the distal end of the sleeve 1120 and a distal end of
each suture 1122 includes an attached suture loop or bead 1123. The
suture loops or beads 1123 are designed to add weight to the distal
end of the sleeve 1120 to pull the sleeve 1120 into the proper
implant orientation. Since the suture loops or beads 1123 each have
a spherical shape, they have no sharp edges and are atraumatic to
body tissues.
[0181] FIG. 12A is an illustration of an intragastric device 1230
having an oval shaped wire mesh structure 1231 deployed in the
gastrointestinal tract of a patient, in accordance with one
embodiment of the present specification. In the pictured
embodiment, the device 1230 includes a wire mesh structure 1231
having an anti-migration collar 1234 and attached sleeve 1232. The
device 1230 is deployed such that the wire mesh structure 1231
resides in the stomach 1260 with the anti-migration collar 1234
positioned just proximal to the pylorus 1261 and the sleeve 1232
extending through the pylorus 1261 and into the duodenum 1270. The
distal end of the sleeve 1232 resides in the duodenum 1270. The
anti-migration collar prevents migration of the totality of the
device 1230 through the pylorus 1261 and into the duodenum 1270.
The device 1230 occupies a volume of the stomach 1260, does not
move entirely past the pylorus 1261, and provides a bypass for food
past the pylorus 1261 and a portion of the duodenum 1270. In
various embodiments, the sleeve 1232 is a short sleeve having a
length in a range of 5 cm-120 cm. In one embodiment, the sleeve
1232 is a short sleeve having a total length of 60 cm. In some
embodiments, the short sleeve 1232 functions to weigh down wire
mesh structure 1231 and orient the wire mesh structure 1231 in the
correct direction toward the pylorus 1261. In addition, in one
embodiment, the device 1230 having a short sleeve 1232 is capable
of moving freely within the patient's stomach 1260 after
deployment. The short sleeve 1232 is capable of passing back and
forth through the pylorus 1261 atraumatically. During situations
when the device 1230 has moved such that the short sleeve 1232 is
not positioned within the pylorus 1261 and duodenum 1270 but is
rather in the stomach 1260 with the remainder of the device 1230,
the short sleeve also functions to impede and regulate the flow of
food into the pylorus 1261. This occurs as food enters the device
1230 at the proximal end of the wire mesh structure 1231 and
travels through the wire mesh structure 1231 and sleeve 1232, where
its progress is slowed as it passes through the funnel shaped
sleeve 1232. At no time during its proper function is the device
fixedly or permanently anchored to the wall of the gastrointestinal
tract. After deployment, fora majority of its functional time, at
least a portion of the device or the entire device is free to move
relative to the stomach or small intestine. As a result of its
included lumen, at no time during its normal function does the
device completely or permanently block the passage of gastric
contents into the small intestine for any clinically meaningful
duration of time. Based on the shape of the sleeve, in various
embodiments, the device can increase, decrease, or have no effect
on, gastric emptying.
[0182] FIG. 12B is an illustration of an intragastric device 1240
having an oval shaped wire mesh structure 1241 deployed in the
gastrointestinal tract of a patient, in accordance with another
embodiment of the present specification. The wire mesh structure
1241 is positioned in the patient's stomach 1260 and includes an
anti-migration collar 1244 to which is attached a sleeve 1242. The
sleeve 1242 includes a proximal, funnel shaped portion 1242p which
resides in the stomach, just proximal to the pylorus 1261. The
sleeve 1242 also includes a distal, cylindrically shaped portion
1242d which passes through the pylorus 1261 and the duodenum 1270
and ends in the jejunum 1272, where it releases the gastric
contents passing through the intragastric device 1240, effectively
bypassing the pylorus 1261 and duodenum 1270. In another
embodiment, the sleeve has a shorter length and ends in the
duodenum such that gastric contents passing through the
intragastric device bypass only the pylorus and a proximal portion
of the duodenum. At no time during its proper function is the
device fixedly or permanently anchored to the wall of the
gastrointestinal tract. After deployment, for a majority of its
functional time, at least a portion of the device or the entire
device is free to move relative to the stomach or small intestine.
As a result of its included lumen, at no time during its normal
function does the device completely or permanently block the
passage of gastric contents into the small intestine for any
clinically meaningful duration of time. Based on the shape of the
sleeve, in various embodiments, the device can increase, decrease,
or have no effect on, gastric emptying.
[0183] FIG. 13A is an illustration of a first exemplary delivery
device 1350 for an intragastric device 1300, in accordance with one
embodiment of the present specification. An intragastric device
1300, comprising a compressed wire mesh structure 1301 and sleeve
1302, is positioned coaxially about the distal end of the delivery
device or catheter 1350. A suture or thread 1340 is wrapped about
the intragastric device 1300, maintaining the intragastric device
1300 in its compressed configuration. The catheter 1350 further
includes a thread port 1358 from which the suture or thread 1340
used to compress the intragastric device 1300 exits the proximal
end of the catheter 1350. A physician pulls on the free end 1359 of
the suture or thread 1340 to release the intragastric device 1300.
In one embodiment, the catheter 1350 also includes a locking
mechanism 1355 for locking the device 1350 in position.
[0184] FIG. 13B is a flow chart illustrating the steps involved in
delivering an intragastric device using the delivery device of FIG.
13A, in accordance with one embodiment of the present
specification. At step 1310, a compressed intragastric device is
placed coaxially over the distal end of the delivery device or
catheter. The catheter is then inserted endoscopically into the
patient and its distal end is advanced to the duodenum at step
1312. Then, at step 1314, the distal end of the catheter is
positioned such that the wire mesh structure of the intragastric
device is in the stomach just proximal to the pylorus and the
sleeve of the device passes through the pylorus and into the
duodenum. At step 1316, the physician pulls on the free end of the
thread to remove the constricting thread from about the
intragastric device, allowing the intragastric device to expand
automatically. Finally, at step 1318, the catheter is slid
coaxially away from the intragastric device and removed from the
patient.
[0185] In various embodiments, the delivery device includes
atraumatic distal ends.
[0186] FIG. 14A is an illustration of a wire mesh structure 1401 of
an intragastric device 1400 being loaded onto a delivery device, in
accordance with one embodiment of the present specification.
Referring to FIG. 14A, a portion of the inner catheter 1431 and
pilot component 1437 of the delivery device are depicted. The
delivery device includes a proximal spherical component 1435 at the
transition from inner catheter 1401 to pilot component 1437. The
wire mesh structure 1401 includes a sleeve 1402 attached to its
anti-migration collar 1404. When loading the intragastric device
1400 onto the delivery device, the pilot component 1437 is passed
through an off-center opening between the wires of the wire mesh
structure 1401 such that the proximal spherical component 1435 is
positioned just distal to the wire mesh structure 1401 and the
inner catheter 1431 lies within the internal volume of the wire
mesh structure 1401.
[0187] FIG. 14B is an illustration of the wire mesh structure 1401
of FIG. 14A further loaded onto the delivery device. The proximal
end of the wire mesh structure 1401 has been compressed and is now
contained within the distal end of the outer catheter 1432 of the
delivery device. The proximal spherical component is no longer
visible as the wire mesh structure 1401 has been advanced
proximally along the inner catheter 1431.
[0188] Referring to FIG. 14B, the inner catheter is depicted
exiting the wire mesh structure 1401 through an opening offset from
center of the wire mesh structure 1401. The sleeve is then wrapped
coaxially about the inner catheter as described with reference to
FIG. 14C. In another embodiment, the inner catheter (and attached
pilot component) continues within the wire mesh structure and exits
through an opening in a side of the proximal, funnel shaped portion
of the sleeve. In another embodiment, the inner catheter continues
within the wire mesh structure and exits through an opening in a
side of the distal, cylindrically shaped portion of the sleeve. In
yet another embodiment, the inner catheter continues within the
wire mesh structure, passes through the entire sleeve, and exits
through the opening in the distal end of the sleeve.
[0189] FIG. 14C is an illustration of the wire mesh structure 1401
of FIG. 14A loaded onto the delivery device such that only the
anti-migration collar 1404 remains to be loaded. FIG. 14D is an
illustration of the wire mesh structure of FIG. 14A fully loaded
onto the delivery device. Referring to FIG. 14D, the wire mesh
structure is no longer visible as it is fully contained within the
distal end of the outer catheter 1432. The sleeve 1402 is depicted
wrapped coaxially about the inner catheter 1431.
[0190] FIG. 14E is an illustration of a sleeve 1402 of the
intragastric device of FIG. 14A partially loaded onto the delivery
device. A portion of the sleeve 1402, wrapped coaxially about the
inner catheter 1431, is visible extending from the distal end of
the outer catheter 1432. FIG. 14F is an illustration of the
intragastric device of FIG. 14A fully loaded onto the delivery
device. The proximal spherical component 1435 is positioned at the
distal end of the outer catheter 1432. In one embodiment, a
plurality of sutures 1405 extending from the distal end of the
sleeve are tied about the proximal spherical component 1435 to
maintain the intragastric device in place until ready for delivery.
Prior to delivery, the sutures 1405 are undone so the intragastric
device may be deployed.
[0191] FIG. 15A is an illustration of a retrieval device 1500 for
removing an intragastric device in accordance with another
embodiment of the present specification. The retrieval device 1500
includes a flexible outer tube 1502 comprising an elongate body
having a proximal end, a distal end, and a lumen within. A first
handle 1512 is attached to the proximal end and an opening 1522 is
positioned at the distal end of the outer tube 1502. A flexible
inner member 1504 comprising an elongate body with a proximal end
and a distal end is disposed within the lumen of the outer tube
1502. In one embodiment, the inner member 1504 comprises a flexible
metal wire. A second handle 1514 is attached to the proximal end
and a retrieval mechanism 1524 is formed from the distal end of the
inner member 1504. In one embodiment, the retrieval mechanism 1524
comprises a hook. In one embodiment, the hook is lockable.
[0192] FIG. 15B is a flow chart illustrating the steps involved in
removing an intragastric device from a patient using the retrieval
device of FIG. 15A, in accordance with one embodiment of the
present specification. At step 1532, a physician inserts the outer
tube of the retrieval device into a working channel of an endoscope
inserted into a patient. At this point, the retrieval mechanism at
the distal end of the inner member is contained within the distal
end of the outer tube. At step 1534, the physician holds the first
handle securely to position the retrieval device within the
gastrointestinal tract of the patient. Then, at step 1536, the
physician pushes on the second handle to extend the retrieval
mechanism through the opening and beyond the distal end of the
outer tube. The physician manipulates the second handle to grasp a
proximal end of the intragastric device with the retrieval
mechanism at step 1538. In one embodiment, the proximal end of the
intragastric device includes a set of staggered nodes, as depicted
as nodes 1615 with reference to FIG. 16B, to ease grasping with the
retrieval mechanism. Once the intragastric device has been secured
by the retrieval mechanism, the physician pulls on the second
handle to pull the retrieval mechanism and at least a portion of
the attached intragastric device into the distal end of the outer
tube at step 1540. The intragastric device is composed of a shape
memory metal so that it is easily compressible to a size capable of
fitting into said outer tube. Optionally, at step 1542, the
physician actuates a locking mechanism on the retrieval device to
prevent the retrieval mechanism and attached intragastric device
from slipping out of the distal end of the outer tube. Finally, at
step 1544, the physician removes the retrieval device and attached
intragastric device from the patient.
[0193] In one embodiment, the wire mesh structure of the
intragastric device is covered in an expandable balloon. The
balloon forms an enveloping layer on the mesh structure and
protects the structure from stomach acids. In one embodiment, the
balloon is made up of silicone and can be compressed to the size of
a capsule for delivery. As the wire mesh expands after the
delivery, if conforms to the shape of the balloon.
[0194] FIG. 16A shows a balloon covered wire mesh device before
deployment, compressed to the size of a capsule. In various
embodiments, the size of capsule 1601 is in the range of 8
mm.times.13 mm. In some embodiments, the balloon covered wire mesh,
in the compressed configuration, is swallowed by the user for
delivering the device to the user's gastrointestinal tract. Once
exposed to gastric contents, the balloon expands with the wire mesh
expanding within the balloon. In other embodiments, the balloon
covered wire mesh, in the compressed configuration, is delivered
via a delivery device or catheter, to the patient's
gastrointestinal tract. Once released from the delivery device, the
balloon covered wire mesh expands, via the shape memory properties
of the wire mesh, to its post-deployment configuration.
[0195] FIG. 16B shows a post deployment configuration of the
device, where the balloon 1610 around the wire mesh device expands.
In one embodiment, the device includes one or more sutures to hold
the balloon to the wire mesh. As described earlier, the wire mesh
itself expands upon deployment. Therefore, in one embodiment, the
balloon envelops the mesh in a glove-like configuration and
protects the mesh device from exposure to acid. Compared to a
silicone coating over the wires of the mesh, the present
configuration substantially slows down the exposure of the wire
mesh to acid, thereby preventing rapid corrosion of the Nitinol
material of the mesh and prolonging the life of the device. In some
embodiments, the balloon covering provides the device with a
functional lifespan of at least one to two years wherein corrosion
of the wires of the mesh by gastric acid does not occur until after
at least one year.
[0196] In some embodiments, the balloon envelope, and wire mesh,
expand to have a volume in a range of 400-450 ml after deployment.
In some embodiments, the balloon is inflated with air, saline,
water or any other suitable medium to assist with expansion of the
balloon and allow for expansion of the wire mesh.
[0197] In some embodiments, an intragastric device of the present
specification is an anchorless device comprising a compressible
free-floating structure instead of the wire mesh structure
described in other embodiments. The free-floating structure is
attached to a sleeve in a manner similar to the previous
embodiments, and the sleeve passes through the pylorus and into the
duodenum. In various embodiments, the free-floating component in
the stomach keeps the sleeve in place, rendering the sleeve
effectively anchorless. That is, the sleeve is not physically
attached to any part of the GI tract. In one embodiment, the
intragastric device comprising the free-floating component and
sleeve is atraumatic and does not damage the GI tissue.
[0198] As known in the art, the sleeve is generally anchored or
stented below the pylorus. In the present specification, however, a
free floating component is attached to the sleeve at its proximal
end and designed to keep the sleeve in place by remaining in the
area above the pylorus. Therefore, the component stays in the
stomach, proximal to the pylorus, and the sleeve extends through
the pylorus and into the mid-duodenum. Gastric contents enter the
sleeve proximal to the pylorus, travel through the sleeve, and exit
the sleeve in the mid-duodenum, bypassing the pylorus, ampulla of
Vater, and proximal duodenum. It may be noted that the present
embodiment does not use the functionality of the wire mesh
structure, which includes food sequestration and delayed gastric
emptying.
[0199] As described earlier with reference to FIGS. 8A through 8F,
embodiments of the wire mesh intragastric device comprise an
anchorless ball or umbrella structure with or without a collar. It
may be noted that the ball or umbrella mesh structure has a
different structure than the sleeve of the device, thereby allowing
a different level of compression. This prevents the ball or
umbrella structure from being passed through the pylorus. The ball
or umbrella thus prevents movement of the sleeve too far back into
the stomach. The compressible free-floating structures described
below also have a different structure than the sleeve allowing a
different level of compression. In various embodiments, the wire
mesh structure (having the food sequestering functionality) or the
compressible free-floating structures (not having the food
sequestering functionality) occupy a volume of the stomach such
that the sleeve can only move approximately 5 cm up into the
stomach.
[0200] FIGS. 17 through 34 illustrate various embodiments of an
anchorless device comprising a compressible free-floating structure
(e.g., anchoring structure) in the stomach with an attached sleeve
which passes through the pylorus and into the duodenum. The free
floating structures in various configurations float in the stomach
and are anchoring structure to keep the sleeve in place in the
intestines. In various embodiments, sleeves are attached by means
of sutures or strings distal to the structure. In one embodiment,
for all configurations of the free floating structure, the
structure together with the sleeve can be delivered by a catheter,
and after deployment the structure is in the stomach and sleeve is
in the duodenum. In one embodiment, the free floating structures in
various configurations are made of Nitinol. In various embodiments,
the free floating structures are space occupying and non-porous,
and do not perform the function of food sequestering. In various
embodiments, no food passes through the free floating structure
component, but passes through the attached sleeve via a first
opening at the proximal end of the sleeve and a second opening at
the distal end of the sleeve, which opens into the mid-duodenum. In
some embodiments, food can enter at a proximal end of the free
floating structure and pass through the structure and into the
sleeve. This however, has no effect on food sequestering or gastric
emptying. In various embodiments, the free floating structure is
composed of a shape memory material such as Nitinol, so that it can
be compressed partially by gastric contractions but is able return
to its original shape.
[0201] Referring to FIG. 17, a proximal end of a sleeve 1715 has a
plurality of attachments 1717 extending therefrom and is joined to
a parachute-like free floating structure 1718 to form an
intragastric device 1700, in accordance with one embodiment of the
present specification. In some embodiments, the free floating
structure is covered, such as with a mesh structure and/or a
membrane. In various embodiments, the attachments 1717 comprise
sutures, strings, or metal wires. In various embodiments, the
sleeve 1715 includes two or more pairs of attachments 1717. In one
embodiment, the sleeve 1715 includes six pairs of attachments 1717.
In various embodiments, the attachments 1717 have a length in a
range of 5 mm to 500 mm. In one embodiment, the attachments 1717
are composed of nylon. A distal end 1723 of each attachment 1717 is
attached to the proximal end of the sleeve 1715 and a proximal end
1722 of each attachment 1717 is attached to the free floating
structure 1718. In various embodiments, the free floating structure
1718 is glued to each attachment 1717. In at least one embodiment,
the free floating structure 1718 includes a plurality of
petal-shaped elements 1721 that extend radially and distally from a
central element 1720. In various embodiments, the free floating
structure 1718 has a diameter in a range of 3 mm to 30 mm. The free
floating structure 1718 is designed to add weight to the proximal
end of the sleeve 1715 to pull the sleeve 1715 into the proper
orientation for deployment. The device 1700 is anchorless as the
sleeve 1715 is not physically attached to any part of the GI tract.
Owing to its shape, free floating structure 1718 has no sharp edges
and is atraumatic to body tissues. Food passes through the spaces
1716 between the attachments 1717 into the sleeve 1715 and exits
through the distal end of the sleeve 1715.
[0202] In one embodiment, the parachute structure is inverted. It
may be noted that the normal parachute design might block larger
particulate from passing through the pylorus. Inverting the
structure allows larger food particles to pass through. In another
embodiment, a hole is added at the top of the normal parachute
structure to allow larger particles to pass through.
[0203] FIG. 18A illustrates another embodiment of a free floating
structure 1818 with sleeve 1815 of an intragastric device 1800.
Referring to FIG. 18A, proximal end 1816 of a sleeve 1815 is joined
to a double disc-shaped free floating structure 1818, in accordance
with one embodiment of the present specification. In one
embodiment, the sleeve 1815 is attached to the double disc-shaped
structure 1818 by means of strings (not shown). In other
embodiments, the double disc-shaped structure 1818 is glued to the
sleeve 1815.
[0204] FIG. 18B illustrates a double disc-shaped structure 1825
with sleeve 1835 of an intragastric device 1820 in accordance with
another embodiment of the present specification. In one embodiment,
the double disc-shaped structure 1825 comprises an upper disc 1822
and a lower disc 1824. In an embodiment, the upper disc 1822 has a
larger diameter than the lower disc 1824 after deployment. In
various embodiments, the upper disc 1822 has a diameter in a range
of 3 mm to 30 mm, while the lower disc 1824 has a diameter in the
range of 1 to 20 mm. In another embodiment (not shown), the lower
disc has a larger diameter than the upper disc. The double
disc-shaped structure 1825 is designed to add weight to the
proximal end 1836 of the sleeve 1835 to keep the sleeve in place
after deployment. Owing to its shape, free floating structure 1825
has no sharp edges and is atraumatic to body tissues.
[0205] FIG. 19 illustrates another embodiment of a free floating
structure 1918 with sleeve 1915 of an intragastric device 1900.
Referring to FIG. 19, proximal end 1916 of a sleeve 1915 is joined
to a horseshoe-shaped free floating structure 1918, in accordance
with one embodiment of the present specification. In one
embodiment, the sleeve 1915 is attached to the horseshoe-shaped
structure 1918 by means of strings (not shown). In other
embodiments, the horseshoe-shaped structure 1918 is glued to the
sleeve 1915. In various embodiments, the horseshoe has a width in a
range of 3 mm to 30 mm at its widest part. The horseshoe 1918 is
designed to add weight to the proximal end 1916 of the sleeve 1915
to keep the sleeve 1915 in place after deployment. The device is
anchorless as the sleeve is not physically attached to any part of
the GI tract. Owing to its shape, free floating structure 1918 has
no sharp edges and is atraumatic to body tissues. Food enters
through the gap 1920 in the horseshoe shaped structure into the
proximal end of the sleeve 1916 and exits through the distal end
1935 of the sleeve.
[0206] FIGS. 20A and 20B illustrate top-down and side views
respectively, of another embodiment of a free floating structure
2018 and sleeve 2035 of an intragastric device 2000. A circular
mesh-shaped free floating structure 2018 is attached to the
proximal end 2016 of a sleeve 2015. In one embodiment, the sleeve
2015 is attached to the free floating structure 2018 by means of
sutures (not shown). In other embodiments, the free floating
structure 2018 is glued to the sleeve 2015. In one embodiment, the
circular mesh-shaped structure 2018 comprises first and second
curved layers 2020 and 2030, which open up to form an inverted
umbrella-like shape after deployment. In various embodiments, the
top curved layer 2020 of the structure is smaller and has a
diameter in a range of 3 mm to 30 mm, while the bottom curved layer
2030 is larger. The free floating structure 2018 is designed to add
weight to the proximal end 2016 of the sleeve 2015 to keep the
sleeve in place after deployment. The device 2000 is anchorless as
the sleeve 2035 is not physically attached to any part of the GI
tract. Owing to its shape, free floating structure 2018 has no
sharp edges and is atraumatic to body tissues. Food enters through
the mesh structure into the sleeve and exits through the distal end
2035 of the sleeve.
[0207] FIG. 21A illustrates another embodiment of a free floating
structure 2118 with sleeve 2115 of an intragastric device 2100.
Referring to FIG. 21A, proximal end of a sleeve 2115 is joined to a
double-teardrop or water drop-shaped free floating structure 2118.
In accordance with one embodiment of the present specification, the
structure 2118 comprises an upper teardrop portion 2118A in an
upright configuration and a lower teardrop portion 2118B in an
inverted or upside-down configuration. The two teardrop portions
are joined at a junction point 2118C at the distal end of the top
teardrop 2118A and the proximal end of the bottom teardrop 2118B.
In one embodiment, the sleeve 2115 is attached to the double
teardrop shaped structure 2118 by means of sutures (not shown). In
other embodiments, the double teardrop-shaped structure 2118 is
glued to the sleeve 2115. In various embodiments, the
double-teardrop structure 2118 has a diameter in a range of 3 mm to
30 mm at its widest point. In one embodiment, the entirety of the
double teardrop shaped free floating structure 2118 is positioned
in the stomach and the sleeve extends through the pylorus and into
the mid-duodenum. In another embodiment, the junction point 2218C
of the double teardrop structure 2118 is configured to be
positioned at a patient's pylorus such that the upper teardrop
portion 2118A resides in the stomach and the lower teardrop portion
2118B resides in the proximal duodenum. The double-teardrop shaped
structure 2118 is designed to add weight to the proximal end 2144
of the sleeve 2115 to keep the sleeve 2115 in place after
deployment. The device 2100 is anchorless as the sleeve 2115 is not
physically attached to any part of the GI tract. Owing to its
shape, free floating structure 2118 has no sharp edges and is
atraumatic to body tissues. Food enters through the double
teardrop-shaped structure 2118 and exits through the distal end
2135 of the sleeve. In another embodiment, food enters through a
hole (not shown) at the proximal end of the sleeve 2115 and exits
through its distal end 2135.
[0208] FIG. 21B illustrates another embodiment of a free floating
structure 2128 with sleeve 2125 of an intragastric device 2120.
Referring to FIG. 21B, proximal end of a sleeve 2125 is joined to a
free floating structure 2128 comprising an upper portion 2128A, a
middle portion 2128B and a lower portion 2128C. In one embodiment,
upper portion 2128A is umbrella shaped while lower portion 2118C is
in the shape of an inverted umbrella. The middle portion 2128B is
cylindrical in one embodiment, and has a diameter ranging from 3 mm
to 30 mm. In one embodiment, the sleeve 2125 is attached to the
free floating structure 2128 by means of sutures (not shown). In
other embodiments, the free floating structure 2128 is glued to the
sleeve 2125. The free floating structure 2128 is designed to add
weight to the proximal end of the sleeve 2125 to keep the sleeve
2125 in place after deployment. The device 2100 is anchorless as
the sleeve 2120 is not physically attached to any part of the GI
tract. Owing to its shape, free floating structure 2128 has no
sharp edges and is atraumatic to body tissues. Food enters through
the free floating structure 2128 and exits through the distal end
2145 of the sleeve. In another embodiment, food enters through a
hole (not shown) at the proximal end of the sleeve 2125 and exits
through its distal end 2145.
[0209] FIG. 22 illustrates another embodiment of a free floating
structure 2218 with sleeve 2215 of an intragastric device 2200.
Referring to FIG. 22, proximal end of a sleeve 2215 is joined to a
bulb-shaped free floating structure 2218, in accordance with one
embodiment of the present specification. In one embodiment, the
sleeve 2215 is attached to the bulb-shaped structure 2218 by means
of sutures (not shown). In other embodiments, the bulb-shaped
structure 2218 is glued to the sleeve 2215. In various embodiments,
the bulb has a diameter in a range of 3 mm to 30 mm at its widest
part. The bulb 2218 is designed to add weight to the proximal end
of the sleeve 2215 to keep the sleeve 2215 in place after
deployment. The device 2200 is anchorless as the sleeve 2215 is not
physically attached to any part of the GI tract. Owing to its
shape, free floating structure 2218 has no sharp edges and is
atraumatic to body tissues. Food enters through an opening at the
top of the bulb-shaped structure 2218 and exits through the distal
end 2235 of the sleeve.
[0210] FIG. 23 illustrates another embodiment of a free floating
structure 2318 with sleeve 2315 of an intragastric device 2300.
Referring to FIG. 23, proximal end of a sleeve 2315 is joined to a
free floating structure 2318 comprising an inner portion 2318A and
an outer portion 2318B. In one embodiment, the inner portion 2318A
is in the shape of an inverted cone, while the outer portion 2318B
comprises structural elements 2318C arranged in the shape of an
inverted square pyramid. In one embodiment, the structural elements
2318C of outer portion 2318B comprise wires, sutures, or strings.
In one embodiment, the inner and outer portions of the free
floating structure 2318 are attached to the sleeve 2315 by means of
a junction component 2318D. The free floating structure 2318 is
designed to add weight to the proximal end of the sleeve 2315 to
keep the sleeve 2315 in place after deployment. The device 2300 is
anchorless as the sleeve 2315 is not physically attached to any
part of the GI tract. Owing to its shape, free floating structure
2318 has no sharp edges and is atraumatic to body tissues. Food
enters through the free floating structure into the sleeve and
exits through the distal end 2335 of the sleeve 2315.
[0211] FIG. 24 illustrates yet another embodiment of a free
floating structure 2418 with sleeve 2415 of an intragastric device
2400. Referring to FIG. 24, proximal end of a sleeve 2415 is joined
to a ball or balloon-shaped free floating structure 2418. In
accordance with one embodiment of the present specification, the
balloon shaped structure 2418 includes a collar 2418A at its distal
end which serves to position the device 2400 in the stomach. In one
embodiment, after deployment, the collar 2418A is placed in the
duodenal bulb, distal to the pylorus and the balloon shaped
free-floating portion 2418 is placed in the stomach, proximal to
the pylorus. In one embodiment, the sleeve 2415 is attached to the
balloon-shaped structure 2418 by means of sutures (not shown). In
other embodiments, the balloon-shaped structure 2418 is glued to
the sleeve 2415. In various embodiments, the balloon has a width in
a range of 3 mm to 30 mm at its widest part. The balloon-shaped
structure 2418 is designed to add weight to the proximal end of the
sleeve 2415 to keep the sleeve 2415 in place after deployment. The
device 2400 is anchorless as the sleeve 2415 is not physically
attached to any part of the GI tract. Owing to its shape, free
floating structure 2418 has no sharp edges and is atraumatic to
body tissues. Food enters through a hole (not shown) at the
proximal end of the sleeve 2415 and exits through its distal end
2435.
[0212] FIGS. 25A through 25C illustrate some other embodiments of a
free floating structure 2518A, 2518B, 2518C with sleeve 2515A,
2515B, 2515C of an intragastric device 2500A, 2500B, 2500C, where
the free floating structure 2518A, 2518B, 2518C is flower-shaped.
Referring to FIG. 25A, proximal end of a sleeve 2515A is joined to
a free floating structure 2518A comprising two square shaped layers
2516A and 2517A. In one embodiment, a first square shaped layer
2516A is placed diagonally on the top of the second square shaped
layer 2517A. The two layers are kept in place by means of a
crosswire 2519A placed at the top of both the layers in one
embodiment. In another embodiment shown in FIG. 25B, a crosswire
2519B is placed in between the two square shaped layers 2516B and
2517B of a free floating structure 2518B.
[0213] Referring to FIG. 25C, a third embodiment of the flower
shaped free floating structure 2518C is shown, joined to the
proximal end of the sleeve 2515C. Each of the flower-shaped free
floating structures 2518A, 2518B, 2518C of the embodiments
described in FIGS. 25A, 25B and 25C is designed to add weight to
the proximal end of the sleeve 2515A, 2515B, 2515C to keep the
sleeve 2515A, 2515B, 2515C in place after deployment. In one
embodiment, the sleeve 2515A, 2515B, 2515C is attached to the
flower-shaped structure 2518A, 2518B, 2518C by means of sutures
(not shown). In other embodiments, the flower-shaped structure
2518A, 2518B, 2518C is glued to the sleeve 2515A, 2515B, 2515C. The
device 2500A, 2500B, 2500C is anchorless as the sleeve 2515A,
2515B, 2515C is not physically attached to any part of the GI
tract. Owing to its shape, free floating structure 2518A, 2518B,
2518C has no sharp edges and is atraumatic to body tissues. Food
enters through the free floating structure 2518A, 2518B, 2518C into
the sleeve 2515A, 2515B, 2515C and exits through the distal end of
the sleeve 2515A, 2515B, 2515C. In another embodiment, food enters
through a hole (not shown) at the proximal end of the sleeve 2515A,
2515B, 2515C and exits through its distal end.
[0214] FIG. 26 illustrates another embodiment of a free floating
structure 2618 with sleeve 2615 of an intragastric device 2600.
Referring to FIG. 26, proximal end 2634 of a sleeve 2615 is joined
to a bobbin-shaped free floating structure 2618. In accordance with
one embodiment of the present specification, the structure 2618
comprises an upper disc portion 2618A, a lower disc portion 2618B,
and a middle portion 2618C. In one embodiment, the upper disc
portion 2618A and a lower disc portion 2618B have an equal
diameter. In one embodiment, the diameter of the middle portion
2618C is smaller than that of the upper and lower portions. In one
embodiment, the sleeve 2615 is attached to the bobbin-shaped
structure 2618 by means of sutures (not shown). In other
embodiments, the bobbin-shaped structure 2618 is glued to the
sleeve 2615. The bobbin shaped structure 2618 is designed to add
weight to the proximal end 2634 of the sleeve 2615 to keep the
sleeve 2615 in place after deployment. The device 2600 is
anchorless as the sleeve 2615 is not physically attached to any
part of the GI tract. Owing to its shape, free floating structure
2618 has no sharp edges and is atraumatic to body tissues. Food
enters through the bobbin-shaped structure 2618 and exits through
the distal end 2635 of the sleeve 2615. In another embodiment, food
enters through a hole (not shown) at the proximal end of the sleeve
2615 and exits through its distal end 2635.
[0215] FIG. 27 illustrates another embodiment of a free floating
structure 2718 with sleeve 2715 of an intragastric device 2700.
Referring to FIG. 27, proximal end 2734 of a sleeve 2715 is joined
to a lotus-shaped free floating structure 2718. In accordance with
one embodiment of the present specification, the structure 2718
comprises structural elements 2718A arranged in a lotus-like
configuration. In various embodiments, the structural elements
2718A comprise wires, sutures, or strings. In one embodiment, the
lotus-shaped structure 2718 is held together by a junction 2718B,
which is attached to the proximal end 2734 of the sleeve 2715. In
one embodiment, the proximal end 2734 of the sleeve 2715 is
inserted into the junction 2718B. The lotus shaped structure 2718
is designed to keep the sleeve 2715 from drifting away into the
stomach after deployment. The device 2700 is anchorless as the
sleeve 2715 is not physically attached to any part of the GI tract.
Owing to its shape, free floating structure 2718 has no sharp edges
and is atraumatic to body tissues. Food enters through the gaps
2718C in the lotus-shaped structure 2718 into the sleeve 2715 and
exits through the distal end 2735 of the sleeve 2715.
[0216] FIG. 28 illustrates another embodiment of a free floating
structure 2818 with sleeve 2815 of an intragastric device 2800.
Referring to FIG. 28, proximal end 2834 of a sleeve 2815 is joined
to a free floating structure 2818 which comprises an upper
disc-shaped layer 2820 and a lower inverted umbrella-shaped layer
2830, in accordance with one embodiment of the present
specification. In one embodiment, the sleeve 2815 is attached to
the free floating structure 2818 by means of sutures (not shown).
In other embodiments, the free floating structure 2818 is glued to
the sleeve 2815.
[0217] In various embodiments, the upper layer 2820 of the free
floating structure 2818 is smaller and has a diameter in a range of
3 mm to 30 mm, while the lower layer 2830 is larger. In one
embodiment, both the layers are equal in diameter. The free
floating structure 2818 is designed to add weight to the proximal
end of the sleeve 2815 to keep the sleeve in place after
deployment. The device 2800 is anchorless as the sleeve 2815 is not
physically attached to any part of the GI tract. Owing to its
shape, free floating structure 2818 has no sharp edges and is
atraumatic to body tissues. Food enters through the free floating
structure 2818 into the sleeve 2815 and exits through the distal
end 2835 of the sleeve 2815. In another embodiment, food enters
through a hole (not shown) at the proximal end 2834 of the sleeve
2815 and exits through its distal end 2835.
[0218] FIG. 29 illustrates another embodiment of a free floating
structure 2918 with sleeve 2915 of an intragastric device 2900.
Referring to FIG. 29, the proximal end of a sleeve 2915 is joined
to a wine glass-shaped free floating structure 2918, in accordance
with one embodiment of the present specification. In one
embodiment, the proximal end of the sleeve 2915 is broader than the
body of the sleeve 2900, and the diameter of the proximal end
matches that of the base 2920 of the wine glass shaped structure.
In one embodiment, the base has a diameter in a range of 3 mm to 30
mm. In one embodiment, the sleeve 2915 is attached to the wine
glass-shaped structure 2918 by means of sutures (not shown). In
other embodiments, the wine glass-shaped structure 2918 is glued to
the sleeve 2915. In one embodiment, the wine glass structure 2918
comprises connecting portions 2921 and support structure 2922. In
one embodiment, the connecting portions 2921 comprises a non-porous
membrane and the support structure 2922 comprises wires, sutures,
or strings. The wine glass structure 2918 is designed to add weight
to the proximal end of the sleeve 2915 to keep the sleeve in place
after deployment. The device 2900 is anchorless as the sleeve 2915
is not physically attached to any part of the GI tract. Owing to
its shape, free floating structure 2918 has no sharp edges and is
atraumatic to body tissues. Food enters through an opening at the
top (not shown) of the wine glass-shaped structure 2918 and exits
through the distal end 2935 of the sleeve 2915.
[0219] FIG. 30 illustrates another embodiment of a free floating
structure 3018 with sleeve 3015 of an intragastric device 3000.
Referring to FIG. 30, proximal end 3034 of a sleeve 3015 is joined
to a double balloon-shaped free floating structure 3018. In
accordance with one embodiment of the present specification, the
structure 3018 comprises an upper balloon portion 3018A in an
upright configuration and a lower balloon portion 3018B in an
inverted or upside-down configuration. The two balloon portions
3018A, 3018B are joined at a junction point 3018C at the distal end
of the top balloon 3018A and the proximal end of the bottom balloon
3018B. In one embodiment, the double balloon-shaped structure 3018
has wires 3018D extending from it, which attach the structure to
the proximal end of the sleeve 3015, which in one embodiment is
conical in shape. In other embodiments, the double balloon-shaped
structure 3018 is glued to the sleeve 3015. In various embodiments,
the double balloon has a diameter in a range of 3 mm to 30 mm at
its widest point. The double balloon shaped structure 3018 is
designed to add weight to the proximal end of the sleeve 3015 to
keep the sleeve 3015 in place after deployment. The device 3000 is
anchorless as the sleeve 3015 is not physically attached to any
part of the GI tract. Owing to its shape, free floating structure
3018 has no sharp edges and is atraumatic to body tissues. Food
enters through an opening 3030 in the double balloon structure 3018
and exits through the distal end 3035 of the sleeve 3015. In
another embodiment, food enters through a hole (not shown) at the
proximal end of the sleeve 3015 and exits through its distal end
3035.
[0220] FIG. 31 illustrates another embodiment of a free floating
structure 3118 with sleeve 3115 of an intragastric device 3100.
Referring to FIG. 31, a free floating structure 3118 is shaped like
a flower and comprises flower petal shaped portions 3119 extending
outward while the sleeve 3515 is funnel shaped and comprises an
upper proximal portion 3115A, a middle transitional portion 3115B
and a lower distal portion 3115C. In one embodiment, lower distal
portion 3115C is a long portion with a consistent diameter along
its length, while the upper proximal portion 3115A is shorter with
a consistent, larger diameter along its length. The middle
transitional portion 3115B in one embodiment has a decreasing
diameter as it extends distally, wherein the diameter at the
proximal end of the transitional portion 3115B is equal to the
diameter of the proximal portion 3115A and the diameter at the
distal end of the transitional portion 3115B is equal to the
diameter of the distal portion 3115C. Food enters through an
opening at the proximal end of the proximal portion 3115A of the
sleeve 3115 and exits through the distal end 3135 of the sleeve
3115.
[0221] In some embodiments, a stent is inserted at the proximal end
of the sleeve to keep the sleeve in place. FIGS. 32 and 33 provide
an illustration of a stent support for a sleeve component of an
intragastric device, in accordance with one embodiment of the
present specification. Referring to FIG. 32, the intragastric
device 3200 comprises a free floating component 3201 and a sleeve
component 3202. In one embodiment, the free floating component
stays in the stomach, proximal to the pylorus 3203, and the sleeve
extends through the pylorus 3203 and into the mid-duodenum. A stent
support 3280 is inserted in the sleeve to prevent migration and
acts as an atraumatic anchor. In various embodiments, the stent
support 3280 may be inserted in the sleeve on either one side or
both the sides of the pylorus 3203. The stent component 3280
provides structural integrity to the sleeve 3202, such that it will
not collapse as a result of intestinal contractions while still
allowing the sleeve component 3202 to be flexible enough to conform
to the curves of the gastrointestinal tract. In one embodiment, the
length of the stent component below the pylorus is of the order of
2-3 inches.
[0222] Referring to FIG. 33, in the pictured embodiment, the stent
support 3380 in the sleeve 3302 includes a plurality of rings 3383
formed from CZ' shape segments of wire. In another embodiment (not
shown), the stent support comprises a continuous spiral wire
support wherein wires of the spiral are configured into `Z` shapes.
Referring again to FIG. 33, some of the rings 3383A are placed in
the area above the pylorus, while the rest of the rings 3383B are
placed in the area below the pylorus 3304. In one embodiment, ring
segments 3383A and 3383B are connected by a wire segment 3384. In
some embodiments, each ring 3383 has length in a range of 1-2 cm.
In some embodiments, each connecting wire 3384 has a length in a
range of 1-2 inches. In one embodiment, the proximal end of the
stent support 3380 includes a funnel shaped ring segment 3386. In
various embodiments, the funnel shaped ring segment 3386 has a
diameter sized to match the diameter of an anti-migration free
floating component at the distal end of a wire mesh structure to
which it will be attached. In one embodiment, the diameter of the
funnel shaped segment 3386 ranges from 2-3 inches.
[0223] FIG. 34 illustrates another embodiment of a free floating
structure 3418 with sleeve 3415 of an intragastric device 3400.
Referring to FIG. 34, a proximal end of a sleeve 3415 is joined to
an orange peel-shaped free floating structure 3418, in accordance
with one embodiment of the present specification. In one
embodiment, the orange peel-shaped structure 3418 comprises a
spiral shaped ribbon 3416 approximating the shape of a peel removed
from an orange. In one embodiment, the structure 3418 is composed
of a shape memory material such as Nitinol, so that it can be
compressed partially by gastric contractions but is able return to
its original shape. In one embodiment, the orange peel structure
3418 has a diameter in a range of 3 mm to 30 mm at its widest part.
In one embodiment, the sleeve 3415 is attached to the orange
peel-shaped structure 3418 by means of sutures (not shown). In
other embodiments, the orange peel-shaped structure 3418 is glued
to the sleeve 3415.
[0224] The orange peel structure 3418 is designed to add weight to
the proximal end of the sleeve 3415 to keep the sleeve 3415 in
place after deployment. The device 3400 is anchorless as the sleeve
3415 is not physically attached to any part of the GI tract. Owing
to its shape, free floating structure 3418 has no sharp edges and
is atraumatic to body tissues. Food enters through spaces 3419 in
the ribbon of the orange peel shaped structure 3418, through an
opening at the proximal end of the sleeve 3415, and exits through
the distal end 3435 of the sleeve 3415.
[0225] In some embodiments of the present specification, a sleeve
of an intragastric device begins just distal to the esophagus,
rather than at and proximate the pylorus and extends through the
duodenum.
[0226] A shown in previous embodiments of FIGS. 2A, 2B, 3A and 3B,
the intragastric device includes a mesh structure and a collar. In
one embodiment, the mesh structure is eliminated and simply the
collar component is attached to the sleeve and acts to keep the
sleeve from migrating. This reduces the size and weight of the
device, besides providing an atraumatic anchoring mechanism.
[0227] Also, the mesh devices of previous embodiments are used to
provide a feeling of fullness. This feature is provided in the
present embodiment by applying pressure at the upper end of the
stomach, near the esophagus, which would add feeling of fullness.
In one embodiment (not shown), an additional free floating
structure, such as a parachute, balloon, collar, etc. is added at
the proximal end of a similar free floating structure. Thus, there
is an upper structure and a lower structure and the two structures
are connected to one another. Further, a sleeve is attached to the
distal end of the lower structure and the entire device is
flexible. In one embodiment, the entire device conforms to shape of
stomach. The bottom end applies pressure to the pyloric section to
stretch the stomach and the top end applies pressure to the
esophageal/cardiac section of stomach to stretch the stomach, both
giving a feeling of fullness.
[0228] It may be noted that while prior art includes an atraumatic
gastrointestinal anchor distal to the pylorus, the embodiments of
the present specification differ in that they do not pierce the
tissue and keep the anchoring structure above the pylorus. Further,
the anchoring structures are free-floating and not attached to any
portion of the GI tract, while still keeping the device in place.
Hence the present device is essentially anchorless.
[0229] In another embodiment, the device comprises a biodegradable
atraumatic anchoring component which disintegrates a few months
after deployment, leaving the device in place. In some embodiments,
the anchoring component degrades after 6 months. In one embodiment,
the intragastric device comprises a stent with a sleeve attached to
it. The device stays in the GI tract after deployment, and a few
months later the sleeve is removed, leaving the stent in place. In
one embodiment, a suture connects the stent to the sleeve. For
removal, a physician pulls on the suture, allowing the sleeve to
detach and be passed. In some embodiments, the sleeve is detached
and passed 3 to 6 months following implantation.
[0230] In one embodiment, the present specification comprises an
anchorless gastrointestinal device having a pre-deployment shape
and a post deployment shape and constituting a rigid member and a
flexible member wherein the flexible member is longer and thinner
than the rigid member in its post-deployment shape and has a
surface optimized for adherence and growth of microorganisms. In
one embodiment, the rigid member is a freely floating mesh
structure and the flexible structure is a freely floating sleeve
structure with a surface designed to promote micro-organism
adherence and growth. Thus, in one embodiment, gastrointestinal
devices of the present specification are used for delivery of
prebiotic or probiotic therapy into a patient's small intestine,
thereby leading to desired therapeutic effect. In one embodiment,
the desired therapeutic effect includes weight loss, glycem is
control, or treatment of irritable bowel syndrome, clostridium
difficile or any other condition responsive to a prebiotic or a
probiotic therapy.
[0231] Benefits of probiotics are well known in the art and include
the decrease of potentially pathogenic gastro-intestinal
microorganisms; the reduction of gastro-intestinal discomfort; the
strengthening of the immune system; the improvement of the skin's
function; the improvement of bowel regularity; the strengthening of
the resistance to cedar pollen allergens; the decrease in body
pathogens; the reduction of flatulence and bloating; the protection
of DNA; the protection of proteins and lipids from oxidative
damage; and the maintaining of individual intestinal microbiota in
subjects receiving antibiotic treatment. Probiotics have to be
alive when administered. However, most of the probiotics
administered orally do not tend to colonize a patient's small bowel
and within a few weeks of cessation of probiotic therapy, the
therapeutic effect also ceases. Thus, continuous administration of
probiotics is required for a sustained therapeutic effect.
[0232] Prior art includes instances of probiotics being
administered by devices planted endoscopically in a patient's
gastrointestinal system. However, administering live bacteria with
an anchored device in the gastrointestinal system increases the
risk of these bacteria entering the patient's blood stream, leading
to serious infections. For example, liver abscesses have been
recently reported owing to the use of probiotics administered by an
anchored sleeve device. The risk of infection increases multifold
in diabetic patients. Therefore, it is not advisable to use
probiotics with an anchored sleeve.
[0233] The above problems of prior art are overcome and the use of
probiotics is leveraged for the benefits of patients in one
embodiment of the present specification, by using anchorless
devices as described above to deliver probiotics to the patient's
gut. In various embodiments, any of the above described anchorless
intragastric devices is used, which has a pre-deployment shape and
a post deployment shape. The anchorless device comprises a rigid
member such as a free floating structure mesh structure, attached
to a flexible member, such as a freely floating sleeve structure.
In one embodiment, the flexible member has a surface optimized for
adherence and growth of microorganisms. In one embodiment, the
flexible member comprises a strip, instead of a sleeve, optimized
for adherence and growth of microorganisms.
[0234] In one embodiment the sleeve structure is impregnated with a
probiotic, such as Lactobacillus or Bifidobacterium. In another
embodiment, the sleeve structure has a surface area optimized to
allow for adherence of microorganisms. In another embodiment, the
sleeve structure has a surface optimized to allow for growth of
microorganisms. In one embodiment the sleeve structure comprises a
corrugated surface. In another embodiment, the sleeve structure has
a honey-comb surface. In another embodiment, the sleeve has woven
fiber structure.
[0235] In another embodiment, the sleeve structure has a surface
optimized to allow for formation of a biofilm with a probiotic
species, such as Bifidobacterium longum or Lactobacillus reuteri. A
biofilm is any group of microorganisms in which cells stick to each
other on a surface. These adherent cells are frequently embedded
within a self-produced matrix of extracellular polymeric substance
(EPS). Biofilm extracellular polymeric substance, which is also
referred to as slime, is a polymeric conglomeration generally
composed of extracellular DNA, proteins, and polysaccharides. As
known in the art, biofilms may form on living or non-living
surfaces.
[0236] In one embodiment, the sleeve structure has an increased
surface area or length to improve biofilm formation.
[0237] In one embodiment, the anchorless intragastric devices of
the present specification are used to deliver prebiotics to a
patient's gut. A prebiotic is a selectively fermented ingredient
that allows specific changes, both in the composition and/or
activity in the gastrointestinal microflora that confers benefits
upon host well-being and health. In diet, prebiotics are typically
non-digestible fiber compounds that pass undigested through the
upper part of the gastrointestinal tract and stimulate the growth
and/or activity of advantageous bacteria that colonize the large
bowel by acting as substrate for them. The prebiotic definition
does not emphasize a specific bacterial group. Generally, however,
it is assumed that a prebiotic should increase the number and/or
activity of bifidobacteria and lactic acid bacteria. The importance
of the bifidobacteria and the lactic acid bacteria (LABs) is that
these groups of bacteria may have several beneficial effects on the
host, especially in terms of improving digestion (including
enhancing mineral absorption) and the effectiveness and intrinsic
strength of the immune system.
[0238] Thus, in one embodiment the sleeve component of the
anchorless intragastric device is impregnated with a prebiotic. In
one embodiment, the sleeve has a microporous structure allowing for
certain nutrients (prebiotics) from inside the sleeve to be
transferred to the bacteria (probiotics) outside the sleeve.
[0239] In another embodiment, the anchorless intragastric devices
of the present specification are used to deliver synergistic
combinations of probiotics and prebiotics, called synbiotics, to a
patient's gut.
[0240] In one embodiment, the sleeve structure carrying a
prebiotic, probiotic or a combination thereof is used for certain
duration to temporarily change the constitution of a patient's
microbiome. In another embodiment, the sleeve structure carrying a
prebiotic, probiotic or a combination thereof is used for certain
duration to permanently change the constitution of a patient's
microbiome.
[0241] It should be appreciated that the present disclosure is
intended to provide a teaching of several exemplary embodiments of
the present invention and is should not be limited to the specific
structures disclosed herein. Other variations of the disclosed
embodiments, which would be understood by those of ordinary skill,
are covered by the present application and are within the scope of
the invention, as further defined by the claims.
* * * * *