U.S. patent application number 14/686996 was filed with the patent office on 2016-02-04 for endoscopic lead implantation method.
The applicant listed for this patent is EndoStim, Inc.. Invention is credited to Paul V. Goode, Bevil Hogg, Shai Policker, Virender K. Sharma.
Application Number | 20160030734 14/686996 |
Document ID | / |
Family ID | 47756947 |
Filed Date | 2016-02-04 |
United States Patent
Application |
20160030734 |
Kind Code |
A1 |
Sharma; Virender K. ; et
al. |
February 4, 2016 |
Endoscopic Lead Implantation Method
Abstract
A method of implanting electrically conductive leads in the
gastrointestinal musculature for stimulation of target tissues
involves an endoscopic approach through the esophagus. An endoscope
is inserted into the esophagus of a patient. The mucosal surface of
the anterior esophagus is punctured in the region encompassing the
lower esophageal sphincter (LES). A tunnel is created through the
submucosa and exits at the muscularis propria, adventitia, or
serosal side of the stomach. The lead is navigated further to the
anterior abdominal wall. A first end of the lead remains within the
gastrointestinal musculature while a second end of the lead is
positioned just outside the anterior abdominal wall. The first end
of the lead comprises at least one electrode. An implantable pulse
generator (IPG) is implanted and operably connected to the second
end of the lead to provide electrical stimulation to target
tissues.
Inventors: |
Sharma; Virender K.;
(Paradise Valley, AZ) ; Policker; Shai; (Tenafly,
NJ) ; Goode; Paul V.; (Round Rock, TX) ; Hogg;
Bevil; (Murrieta, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
EndoStim, Inc. |
St. Louis |
MO |
US |
|
|
Family ID: |
47756947 |
Appl. No.: |
14/686996 |
Filed: |
April 15, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13602184 |
Sep 2, 2012 |
9037245 |
|
|
14686996 |
|
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|
|
61530781 |
Sep 2, 2011 |
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Current U.S.
Class: |
600/424 ;
606/129 |
Current CPC
Class: |
A61B 8/00 20130101; A61B
1/2733 20130101; A61B 7/00 20130101; A61B 1/00087 20130101; A61B
8/0841 20130101; A61B 5/064 20130101; A61B 5/06 20130101; A61N
1/0517 20130101; A61N 1/0509 20130101; A61B 6/12 20130101 |
International
Class: |
A61N 1/05 20060101
A61N001/05; A61B 1/00 20060101 A61B001/00; A61B 7/00 20060101
A61B007/00; A61B 8/08 20060101 A61B008/08; A61B 5/06 20060101
A61B005/06; A61B 6/12 20060101 A61B006/12 |
Claims
1. A method of implanting electrically conductive leads proximal to
a gastrointestinal musculature of a patient utilizing an endoscopic
approach, comprising the steps of: inserting an endoscope into a
gastrointestinal tract of a patient; identifying a gastrointestinal
structure comprising said gastrointestinal musculature; entering a
gastrointestinal (GI) wall with an electrically conductive lead
from a mucosal side by puncturing a mucosa of an anterior segment
of a region proximal to the gastrointestinal structure; creating a
tunnel in a submucosa of the anterior segment of the region
encompassing the gastrointestinal structure, the tunnel exiting the
GI wall through a muscularis propria, adventitia, or serosal side
of the gastrointestinal tract of the patient; navigating the lead
through the tunnel to an anterior abdominal wall; and exiting a
second end of the lead through the anterior abdominal wall while
leaving a first end of the lead proximal to the gastrointestinal
musculature of the patient within the tunnel, wherein the region
encompassing the gastrointestinal structure comprises an area 3 cm
above and 3 cm below the gastrointestinal structure.
2. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 1, wherein said tunnel created in the submucosa of the
anterior segment of the gastrointestinal structure is less than 5
cm in length.
3. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 1, wherein said tunnel created in the submucosa of the
anterior segment of the gastrointestinal structure is within the
range of 1 cm to 5 cm in length.
4. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 1, wherein said first end of said lead is not anchored to a
gastrointestinal tissue.
5. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 1, wherein said first end of said lead is anchored to a
gastrointestinal tissue.
6. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 1, wherein said leads are adapted to electrically stimulate
the gastrointestinal musculature in an amount effective to treat
any one or combination of obesity and gastroesophageal reflux
disease (GERD).
7. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 1, further comprising using magnetic, ultrasound, radiologic,
or fluoroscopic imaging, or physical indicators, mechanical
indicators, or auditory indicators, in addition to visual imaging
to assist in lead navigation.
8. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 1, further comprising subcutaneously implanting an
implantable pulse generator (IPG) proximate the lead exit point in
the anterior abdominal wall.
9. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 8, further comprising attaching said second end of said lead
with said IPG so that said lead can receive pulse signals from said
IPG.
10. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 8, further comprising using wireless communication to
transmit pulse signals from said IPG to said lead.
11. A method of implanting electrically conductive leads proximal
to a gastrointestinal musculature of a patient utilizing an
endoscopic approach, comprising the steps of: inserting an
endoscope into a gastrointestinal tract of a patient; identifying a
gastrointestinal structure comprising said gastrointestinal
musculature; entering the gastrointestinal (GI) wall with an
electrically conductive lead from a mucosal side by puncturing the
mucosa of an anterior segment of a region proximal to the
gastrointestinal structure; creating a tunnel in the submucosa of
the anterior segment of the region encompassing the
gastrointestinal structure, the tunnel exiting the GI wall through
the serosal side of the gastrointestinal tract of the patient;
navigating the lead through the tunnel to the anterior abdominal
wall; and exiting a second end of the lead through the anterior
abdominal wall while leaving a first end of the lead proximal to
the gastrointestinal musculature of the patient within the tunnel,
wherein the region encompassing the gastrointestinal structure
comprises an area 3 cm above and 3 cm below the gastrointestinal
structure.
12. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 11, wherein the tunnel created in the submucosa of the
anterior segment of the gastrointestinal structure is equal to or
greater than 5 cm in length.
13. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 11, wherein said first end of said lead is not anchored to a
gastrointestinal tissue.
14. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 11, wherein said first end of said lead is anchored to a
gastrointestinal tissue.
15. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 11, further comprising a step of insufflating the
stomach.
16. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 11, further comprising the steps of: finding a site where the
stomach is in cross-approximation with the anterior abdominal wall;
securing the stomach with one or more anchors; exiting the serosal
surface of the stomach proximate said site; and entering an
anterior abdominal wall proximate said site.
17. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 11, wherein said leads are used to electrically stimulate the
gastrointestinal musculature in a therapeutically effective amount
to treat any one or combination of obesity and gastroesophageal
reflux disease (GERD).
18. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 11, further comprising using magnetic, ultrasound,
radiologic, or fluoroscopic imaging, or physical indicators,
mechanical indicators, or auditory indicators, in addition to
visual imaging to assist in lead navigation.
19. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 11, further comprising subcutaneously implanting an
implantable pulse generator (IPG) proximate the lead exit point in
the anterior abdominal wall.
20. The method of implanting electrically conductive leads in a
gastrointestinal musculature utilizing an endoscopic approach of
claim 19, further comprising attaching said second end of said lead
with said IPG so that said lead can receive pulse signals from said
IPG.
21. (canceled)
22. (canceled)
23. (canceled)
24. (canceled)
25. (canceled)
26. (canceled)
27. (canceled)
28. (canceled)
29. (canceled)
30. (canceled)
31. (canceled)
32. (canceled)
Description
CROSS REFERENCE
[0001] The present application is a continuation application of
U.S. patent application Ser. No. 13/602,184, entitled "Endoscopic
Lead Implantation Method" and filed on Sep. 2, 2012, which relies
on U.S. Provisional Application No. 61/530,781, of the same title
and filed on Sep. 2, 2011, for priority, both of which are
incorporated herein by reference in their entirety.
FIELD
[0002] The present specification relates generally to the improved
implantation of electrically conductive leads within a patient to
provide electrical stimulation to target tissues and thereby
provide therapy for a multitude of disorders, including obesity and
gastroesophageal reflux disease (GERD). More particularly, the
present specification relates to an improved method of electrically
conductive lead implantation utilizing an endoscopic approach
through the esophagus.
BACKGROUND
[0003] Obesity is a common condition and a major public health
problem in developed nations including the United States of
America. As of 2009, more than two thirds of American adults,
approximately 127 million people, were either overweight or 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
approximately $100 billion annually in direct and indirect health
care expenses and in lost productivity. This trend is also apparent
in many other developed countries.
[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/m.sup.2 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 body mass index (BMI) greater than
40 kg/m.sup.2. 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 attacks; strokes; dyslipidemia; sleep
apnea; pickwickian syndrome; 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 also 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
in affected people by a factor of 10 or more.
[0005] 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 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.
[0006] Currently, most operations used to treat morbid obesity
include lap band surgery or 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 United
States involve combining a gastric restrictive surgery with a
malabsorptive procedure. Typical malabsorptive procedures divide
small intestinal flow into a biliary-pancreatic conduit and a food
conduit. Potential long-term complications 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.
[0007] Other surgical strategies for treating obesity include
endoscopic procedures, many of which are still in development.
Endoscopically placed gastric balloons restrict gastric volume and
result in satiety with smaller meals. Endoscopic procedures and
devices to produce gastric pouch and gastrojejunal anastomosis to
replicate laparoscopic procedures are also in development. These
procedures, however, are not without risks.
[0008] Gastro-esophageal reflux disease (GERD) is another common
health problem and is expensive to manage in both primary and
secondary care settings. This condition results from exposure of
esophageal mucosa to gastric acid as the acid refluxes from the
stomach into the esophagus. The acid damages the esophageal mucosa
resulting in heartburn, ulcers, bleeding, and scarring, and long
term complications such as Barrett's esophagus (pre-cancerous
esophageal lining) and adeno-cancer of the esophagus.
[0009] Lifestyle advice and antacid therapy are advocated as first
line treatment for the disease. However, since most patients with
moderate to severe cases of GERD do not respond adequately to these
first-line measures and need further treatment, other alternatives
including pharmacological, endoscopic, and surgical treatments are
employed.
[0010] The most commonly employed pharmacological treatment is
daily use of H2 receptor antagonists (H2RAs) or proton-pump
inhibitors (PPIs) for acid suppression. Since gastro-esophageal
reflux disease usually relapses once drug therapy is discontinued,
most patients with the disease, therefore, need long-term drug
therapy. However, daily use of PPIs or H2RAs is not universally
effective in the relief of GERD symptoms or as maintenance therapy.
Additionally, not all patients are comfortable with the concept of
having to take daily or intermittent medication for the rest of
their lives and many are interested in nonpharmacological options
for managing their reflux disease.
[0011] Several endoscopic procedures for the treatment of GERD have
been tried. These procedures can be divided into three approaches:
endoscopic suturing wherein stitches are inserted in the gastric
cardia to plicate and strengthen the lower esophageal sphincter,
endoscopic application of energy to the lower esophagus, and
injection of bulking agents into the muscle layer of the distal
esophagus. These procedures, however, are not without their risks,
besides being technically demanding and involving a long procedure
time. As a result, these procedures have largely been
discontinued.
[0012] Open surgical or laparoscopic fundoplication is also used to
correct the cause of the disease. However, surgical procedures are
associated with significant morbidity and small but not
insignificant mortality rates. Moreover, long-term follow-up with
patients treated by surgery suggests that many patients continue to
need acid suppressive medication. There is also no convincing
evidence that fundoplication reduces the risk of esophageal
adenocarcinoma in the long term.
[0013] Gastric electrical stimulation (GES) is another therapy
aimed at treating both obesity and GERD. GES employs an
implantable, pacemaker-like device to deliver low-level electrical
stimulation to the gastrointestinal tract. For obesity, GES
operates by disrupting the motility cycle and/or stimulating the
enteric nervous system, thereby increasing the duration of satiety
experienced by the patient. The procedure involves the surgeon
suturing electrical leads to the outer lining of the stomach wall.
The leads are then connected to the device, which is implanted just
under the skin in the abdomen. Using an external programmer that
communicates with the device, the surgeon establishes the level of
electrical stimulation appropriate for the patient. The
Abiliti.RTM. implantable gastric stimulation device, manufactured
by IntraPace, is currently available in Europe for treatment of
obesity.
[0014] In another example, Medtronic offers for sale and use the
Enterra.TM. Therapy, which is indicated for the treatment of
chronic nausea and vomiting associated with gastroparesis when
conventional drug therapies are not effective. The Enterra.TM.
Therapy uses mild electrical pulses to stimulate the stomach.
According to Medtronic, this electrical stimulation helps control
the symptoms associated with gastroparesis, including nausea and
vomiting.
[0015] Electrical stimulation has also been suggested for use in
the treatment of GERD, wherein the stimulation is supplied to the
lower esophageal sphincter (LES). For example, in U.S. Pat. No.
6,901,295, assigned to Endostim, Inc., "A method and apparatus for
electrical stimulation of the lower esophageal sphincter (LES) is
provided. Electrode sets are placed in the esophagus in an
arrangement that induce contractions of the LES by electrical
stimulation of the surrounding tissue and nerves. The electrical
stimulus is applied by a pulse generator for periods of varying
duration and varying frequency so as to produce the desired
contractions. The treatment may be short-term or may continue
throughout the life of the patient in order to achieve the desired
therapeutic effect. The stimulating electrode sets can be used
either alone or in conjunction with electrodes that sense
esophageal peristalsis. The electrode sets can be placed
endoscopically, surgically or radiologically." The referenced
invention relies on sensing certain physiological changes in the
esophagus, such as changes in esophageal pH, to detect acid reflux.
Once a change in esophageal pH is recognized, the system generates
an electrical stimulation in an attempt to instantaneously close
the LES and abort the episode of acid reflux. U.S. Pat. No.
6,901,295 is hereby incorporated by reference in its entirety.
[0016] Similarly, U.S. Pat. No. 6,097,984, which is incorporated by
reference in its entirety, discloses "a system and method for
directly stimulating the LES of a patient in order to normally
maintain it in a closed state, thereby preventing reflux and
treating the symptoms of GERD. The stimulation is inhibited in
response to patient swallowing, by monitoring esophageal motility
and timing out an inhibition period following detection of motility
representative of swallowing. The system utilizes an implanted
stimulator which is programmed to deliver a train of stimulus
pulses to one or more electrodes fixed around the gastro-esophageal
junction and connected to the stimulator by one or more leads. The
motility sensing is done by a sensor for sensing mechanical wave
movement or electrical signals representative of high motility
following swallowing. The motility sensor and stimulating
electrodes are attached laparoscopically, and are preferably
carried by a common stent carrier which is sutured around the lower
esophagus." In this application, the LES is stimulated to
constantly be in a closed state and instantaneously opened when
swallowing is detected.
[0017] Typically, the leads for GES are implanted in the
gastrointestinal wall using a laparoscopic approach. The
gastrointestinal musculature is entered through the serosal surface
of the stomach. Unfortunately, the use of laparoscopy is not
without its risks and is contraindicated in some patients, such as
individuals who have adhesions from previous abdominal surgeries.
Though it is less invasive than open surgery, laparoscopy still
involves tissue incisions for the introduction of the trocars.
These incision sites must be sutured closed after the procedure and
represent possible infection points. In addition, trocar placement
runs the risk of injuring blood vessels, the large bowel, or other
organs. Laparoscopy also includes the inherent risk of being
converted to open surgery should complications arise during the
procedure. Therefore, a need exists for implanting electrical leads
in the gastrointestinal tract wall of a patient that is less
invasive than current modalities and for those patients for whom
laparoscopy is not an option. In addition, laparoscopy is more
costly, time consuming, and requires a greater period of patient
recovery than less invasive approaches. Therefore, a need exists
for a method of implanting electrical leads in the gastrointestinal
tract wall of a patient that is also quicker and more
cost-effective with less time required for patient healing.
SUMMARY
[0018] The present specification is directed toward a method of
implanting electrically conductive leads in the gastrointestinal
musculature utilizing an endoscopic approach, comprising: a)
inserting an endoscope into an esophagus of a patient; b)
identifying a lower esophageal sphincter (LES); c) entering a
gastrointestinal (GI) wall, with a lead, from a mucosal side by
puncturing a mucosa of an anterior segment of a region encompassing
the LES; d) creating a tunnel in a submucosa of the anterior
segment of the region encompassing the LES; e) exiting the GI wall
through a muscularis propria, adventitia, or serosal side of the
stomach; f) navigating the lead to an anterior abdominal wall; and
g) exiting a second end of the lead through the anterior abdominal
wall while leaving a first end in the gastrointestinal musculature,
wherein the region encompassing the LES comprises an area 3 cm
above and 3 cm below the LES.
[0019] In one embodiment, the tunnel created in the submucosa of
the anterior segment of the LES is less than 5 cm in length. In
another embodiment, the tunnel created in the submucosa of the
anterior segment of the LES is within the range of 1 cm to 5 cm in
length.
[0020] In one embodiment, the first end of said lead is not
anchored to a gastrointestinal tissue. In another embodiment, the
first end of said lead is anchored to a gastrointestinal
tissue.
[0021] In one embodiment, the leads are adapted to electrically
stimulate the gastrointestinal musculature in a therapeutically
effective amount to treat any one or combination of obesity and
gastroesophageal reflux disease (GERD).
[0022] In one embodiment, the method of implanting electrically
conductive leads in the gastrointestinal musculature utilizing an
endoscopic approach further comprises using magnetic, ultrasound,
radiologic, or fluoroscopic imaging, or physical indicators,
mechanical indicators, or auditory indicators, in addition to
visual imaging to assist in lead navigation.
[0023] In one embodiment, the method of implanting electrically
conductive leads in the gastrointestinal musculature utilizing an
endoscopic approach further comprises subcutaneously implanting an
implantable pulse generator (IPG) proximate the lead exit point in
the anterior abdominal wall. In one embodiment, the second end of
said lead is attached with said IPG so that said lead can receive
pulse signals from said IPG. In another embodiment, wireless
communication is used to transmit pulse signals from said IPG to
said lead.
[0024] The present specification is also directed toward a method
of implanting electrically conductive leads in the gastrointestinal
musculature utilizing an endoscopic approach, comprising: a)
inserting an endoscope into the esophagus of a patient; b)
identifying the lower esophageal sphincter (LES); c) entering the
gastrointestinal (GI) wall with a lead from the mucosal side by
puncturing the mucosa of the anterior segment of a region
encompassing the LES; d) creating a tunnel in the submucosa of the
anterior segment of the region encompassing the LES; e) exiting the
GI wall through the serosal side of the stomach; f) navigating the
lead to the anterior abdominal wall; and, g) exiting a second end
of the lead through the anterior abdominal wall while leaving a
first end in the gastrointestinal musculature, wherein the region
encompassing the LES comprises an area 3 cm above and 3 cm below
the LES.
[0025] In one embodiment, the tunnel created in the submucosa of
the anterior segment of the LES is equal to or greater than 5 cm in
length.
[0026] In one embodiment, the first end of said lead is not
anchored to a gastrointestinal tissue. In another embodiment, the
first end of said lead is anchored to a gastrointestinal
tissue.
[0027] In one embodiment, the method of implanting electrically
conductive leads in the gastrointestinal musculature utilizing an
endoscopic approach further comprises the step of insufflating the
stomach. In one embodiment, the method further comprises the steps
of: a) finding a site where the stomach is in cross-approximation
with the anterior abdominal wall; b) securing the stomach with one
or more anchors; c) exiting the serosal surface of the stomach
proximate said site; and d) entering the anterior abdominal wall
proximate said site.
[0028] In one embodiment, the leads are used to electrically
stimulate the gastrointestinal musculature in an effort to treat
any one or combination of obesity and gastroesophageal reflux
disease (GERD).
[0029] In one embodiment, the method of implanting electrically
conductive leads in the gastrointestinal musculature utilizing an
endoscopic approach further comprises using magnetic, ultrasound,
radiologic, or fluoroscopic imaging, or physical indicators,
mechanical indicators, or auditory indicators, in addition to
visual imaging to assist in lead navigation.
[0030] In one embodiment, the method of implanting electrically
conductive leads in the gastrointestinal musculature utilizing an
endoscopic approach further comprises subcutaneously implanting an
implantable pulse generator (IPG) proximate the lead exit point in
the anterior abdominal wall. In one embodiment, the second end of
said lead is attached with said IPG so that said lead can receive
pulse signals from said IPG. In another embodiment, wireless
communication is used to transmit pulse signals from said IPG to
said lead.
[0031] The present specification is also directed toward a method
of implanting electrically conductive leads in the gastrointestinal
musculature utilizing an endoscopic approach, comprising: a)
inserting an endoscope into an esophagus of a patient; b) advancing
said endoscope to a desired implantation site along a
gastrointestinal tract of said patient; c) entering a
gastrointestinal (GI) wall with a lead from a mucosal side by
puncturing a mucosa of an anterior segment of said desired
implantation site; d) creating a tunnel in the submucosa of the
anterior segment of said desired implantation site; e) exiting the
GI wall through a muscularis propria, adventitia, or serosal side
of said desired implantation site; f) navigating a second end of
said lead to a predetermined endpoint within an abdomen of said
patient; and g) leaving a first end of said lead in the
gastrointestinal musculature at said desired implantation site.
[0032] In one embodiment, said predetermined endpoint is within a
peritoneal cavity of said patient. In another embodiment, the
method of implanting electrically conductive leads in the
gastrointestinal musculature utilizing an endoscopic approach
further comprises the step of navigating said second end of said
lead through an anterior abdominal wall of said patient and wherein
said predetermined endpoint is within the subcutaneous region of
the abdomen.
[0033] In one embodiment, the leads are used to electrically
stimulate the gastrointestinal musculature in an effort to treat a
condition of a gastrointestinal system of said patient.
[0034] In one embodiment, the method of implanting electrically
conductive leads in the gastrointestinal musculature utilizing an
endoscopic approach further comprises implanting an implantable
pulse generator (IPG) proximate said predetermined endpoint. In one
embodiment, the second end of said lead is attached with said IPG
so that said lead can receive pulse signals from said IPG. In
another embodiment, wireless communication is used to transmit
pulse signals from said IPG to said lead.
[0035] The aforementioned and other embodiments of the present
specification shall be described in greater depth in the drawings
and detailed description provided below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] These and other features and advantages of the present
specification will be further appreciated, as they become better
understood by reference to the detailed description when considered
in connection with the accompanying drawings:
[0037] FIG. 1 is a flow chart listing the steps involved in a first
method of endoscopic lead implantation in accordance with one
embodiment of the present specification;
[0038] FIG. 2 is an illustration of a patient's abdominal viscera
depicting the lead implantation pathway of the first implantation
method described in the flow chart of FIG. 1;
[0039] FIG. 3 is a flow chart listing the steps involved in a
second method of endoscopic lead implantation in accordance with
one embodiment of the present specification;
[0040] FIG. 4 is an illustration of a patient's abdominal viscera
depicting the lead implantation pathway of the second implantation
method described in the flow chart of FIG. 3; and,
[0041] FIG. 5 is a flow chart listing the steps involved in a third
method of endoscopic lead implantation in accordance with one
embodiment of the present specification.
DETAILED DESCRIPTION
[0042] The present specification is directed toward a method of
implanting electrically conductive leads in the gastrointestinal
musculature utilizing an endoscopic approach. An endoscopic
approach involves entering the gastrointestinal wall from the
mucosal side rather than entering from the serosal side, which is
involved with a laparoscopic approach. The leads are used to
provide electrical stimulation to the gastrointestinal musculature
in an effort to treat a variety of gastrointestinal disorders, such
as, obesity.
[0043] In one embodiment, the endoscopic approach of implanting
leads in the gastrointestinal musculature includes the following
steps. An endoscope is inserted into a patient's esophagus and is
advanced until the lower esophageal sphincter (LES) is identified.
At this point, or within +/-3 cm from the LES, the gastrointestinal
wall is entered from the mucosal side by creating a tunnel through
the submucosa of the anterior segment of the LES. An appropriately
designed catheter is used to bore the tunnel and implant the lead.
The catheter can have mechanisms to assist in guidance such as a
magnet, camera, ultrasound transducer, and the like. One of
ordinary skill in the art would know what features a conventional
catheter would preferably have to most effectively assist in the
execution of the methods disclosed herein.
[0044] The tunnel is continued for a predetermined distance and
then exits through the muscularis propria, adventitia, or serosal
side of the gastrointestinal wall. From this point, the catheter is
used to navigate the lead to the anterior abdominal wall where an
exit point is created. Once implanted, the lead is positioned so
that a first end lies within the gastrointestinal musculature,
anchored or not, while a second end exits through the anterior
abdominal wall and continues subcutaneously until it reaches the
implant location. The first end comprises at least one electrode to
be used for electrical stimulation of the target tissues. In one
embodiment, the second end is operably connected to an implantable
pulse generator.
[0045] In another embodiment, the endoscopic approach of implanting
leads in the gastrointestinal musculature includes the steps listed
above plus the following optional steps. The stomach is insufflated
to assist in lead implantation. A site is located where the stomach
is in cross-approximation with the anterior abdominal wall. The
stomach is then secured with one or more anchors to prevent it from
moving during the implantation process. The lead is then tunneled
through the gastrointestinal musculature, exiting the stomach from
the serosal surface and entering the anterior abdominal wall at the
site located above. The lead then exits through the anterior
abdominal wall as described in the previous embodiment.
[0046] In another embodiment, the endoscopic approach of implanting
leads in the gastrointestinal musculature can be used to implant
leads anywhere in the gastrointestinal tract and comprises the
following steps. An endoscope is inserted into an esophagus of a
patient. The endoscope is advanced to a desired implantation site
along the gastrointestinal tract of the patient. The
gastrointestinal (GI) wall is entered with a lead from the mucosal
side by puncturing the mucosa of an anterior segment of the desired
implantation site. A tunnel is created in the submucosa of the
anterior segment of the desired implantation site. The GI wall is
exited through the muscularis propria, adventitia, or serosal side
of the desired implantation site. A second end of the lead is
navigated to a predetermined endpoint within the abdomen of the
patient. The first end of the lead is left in the gastrointestinal
musculature at the desired implantation site, which may or may not
be anchored. The first end comprises at least one electrode to be
used for electrical stimulation of the target tissues. In one
embodiment, the second end is operably connected to an implantable
pulse generator (IPG).
[0047] In one embodiment, after lead implantation, a pulse
generator is implanted proximate the lead exit point or endpoint in
the abdomen. In one embodiment, the pulse generator is implanted
subcutaneously. In another embodiment, the pulse generator is
implanted within the peritoneal cavity. The pulse generator
transmits impulses to the implanted electrode which in turn
supplies electrical stimulation to the gastrointestinal
musculature. In one embodiment, the lead is physically connected to
the IPG with a wired connection via a metal-to-metal contact at the
proximal end. In another embodiment, the IPG communicates
wirelessly with the lead. The distal end of the lead is provided
with electrodes which are positioned in the gastrointestinal
musculature. In one embodiment the electrodes are left within the
musculature without any anchoring means. In another embodiment, the
electrodes are anchored to the musculature using sutures or similar
structures.
[0048] In various embodiments, proper positioning of the lead is
ensured through the use of magnetic, ultrasound, radiologic, or
fluoroscopic imaging, or other physical, mechanical, or auditory
indicators, in addition to visual observation.
[0049] The present specification is directed toward 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 specification 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.
[0050] FIG. 1 is a flow chart 100 listing the steps involved in a
first method of endoscopic lead implantation in accordance with one
embodiment of the present specification. In the first step 102, an
endoscope is inserted into the esophagus of a patient who is to
receive therapy involving electrical stimulation to the
gastrointestinal musculature. The endoscope is advanced until the
physician is able to identify the lower esophageal sphincter (LES)
104. At this point, the physician uses a catheter to puncture the
mucosa of the gastrointestinal wall at the LES 106. A tunnel is
then bored in the submucosa of the anterior segment of the LES 108.
In one embodiment, the length of the tunnel is greater than or
equal to 1 cm but less than 5 cm.
[0051] A first end of the lead remains within the tunnel created in
the gastrointestinal wall. In one embodiment, the first end
comprises at least one electrode to be used for electrical
stimulation of the target tissues. After boring the tunnel, the
physician then directs the lead through the remainder of the
gastrointestinal wall, exiting through the muscularis propria,
adventitia, or serosal side 110. Once through the entire thickness
of the gastrointestinal wall, the lead is navigated to the anterior
abdominal wall 112. The physician then creates an exit point and
directs a second end of the lead through the anterior abdominal
wall 114. When the lead has been placed in its operative position,
the first end engages the gastrointestinal musculature while the
second end exits through the anterior abdominal wall.
[0052] FIG. 2 is an illustration of a patient's abdominal viscera
depicting the lead implantation pathway 200 of the first
implantation method described in the flow chart of FIG. 1. An
endoscope 202 is depicted in the esophagus 204 of the patient. The
distal end of the endoscope 202 is positioned proximate the LES
208. A submucosal tunnel 214 is bored through the anterior segment
of the LES 208 and the anterior cardiac portion of the stomach 210.
As discussed above, in one embodiment of the first method, the
submucosal tunnel 214 is greater than or equal to 1 cm but less
than 5 cm in length.
[0053] A first end of the lead 206, comprising at least one
electrode, remains in the gastrointestinal musculature. A second
end, opposite said first end, of the endoscopically implanted lead
206 exits the tunnel 214 in the gastrointestinal wall through the
serosal surface of the stomach 210. The second end of the lead 206
then passes through the anterior abdominal wall, resulting in lead
exteriorization 212. A subcutaneously implanted IPG 216 is depicted
proximate the lead exit point in the anterior abdominal wall. The
IPG transmits impulses to the implanted electrode to effectuate
electrical stimulation of the gastrointestinal musculature.
[0054] FIG. 3 is a flow chart 300 listing the steps involved in a
second method of endoscopic lead implantation in accordance with
one embodiment of the present specification. This second method is
similar to the first method discussed above, differing, however, in
the length of the submucosal tunnel and the inclusion of certain
additional steps.
[0055] In the first step 302, an endoscope is inserted into the
esophagus of a patient who is to receive therapy involving
electrical stimulation to the gastrointestinal musculature. The
endoscope is advanced until the physician is able to identify the
lower esophageal sphincter (LES) 304. At this point, the physician
uses a specialized catheter to puncture the mucosa of the
gastrointestinal wall at the LES 306. A tunnel is then bored in the
submucosa of the anterior segment of the LES 308. In one
embodiment, the length of the tunnel is greater than or equal to 5
cm. A first end of the lead remains within the tunnel created in
the gastrointestinal wall. The first end comprises at least one
electrode to be used for electrical stimulation of the target
tissues.
[0056] The stomach is insufflated to facilitate the creation of the
tunnel 310. A site is found and noted where the stomach is in
cross-approximation with the anterior abdominal wall 312. The
stomach is then secured with one or more anchors to prevent
movement 314. The physician then directs the lead through the
remainder of the gastrointestinal wall, exiting through the
muscularis propria, adventitia, or serosal side 316. The exit point
is proximate the site located above 318. The physician then
navigates the lead to the anterior abdominal wall 320 proximate
this same site. The lead then enters 322 and exits 324 the anterior
abdominal wall. When the lead has been placed in its operative
position, the first end engages the gastrointestinal musculature
while the second end exits through the anterior abdominal wall.
[0057] FIG. 4 is an illustration of a patient's abdominal viscera
depicting the lead implantation pathway 400 of the second
implantation method described in the flow chart of FIG. 3. An
endoscope 402 is depicted in the esophagus 404 of the patient. The
distal end of the endoscope 402 is positioned proximate the LES
408. A submucosal tunnel 414 has been bored through the anterior
segment of the LES 408, the anterior cardiac portion of the stomach
410, and the anterior body portion of the stomach 410. As discussed
above, in one embodiment of the second method, the submucosal
tunnel 414 is greater than 5 cm in length.
[0058] A first end of the lead 406, comprising at least one
electrode, remains in the gastrointestinal musculature. A second
end, opposite said first end, of the endoscopically implanted lead
406 exits the tunnel 414 in the gastrointestinal wall through the
serosal surface of the stomach 410. The second end of the lead 406
then passes through the anterior abdominal wall, resulting in lead
exteriorization 412. A subcutaneously implanted IPG 416 is depicted
proximate the lead exit point in the anterior abdominal wall. The
IPG transmits impulses to the implanted electrode to effectuate
electrical stimulation of the gastrointestinal musculature.
[0059] FIG. 5 is a flow chart 500 listing the steps involved in a
third method of endoscopic lead implantation in accordance with one
embodiment of the present specification. In the first step 502, an
endoscope is inserted into the esophagus of a patient who is to
receive therapy involving electrical stimulation to the
gastrointestinal musculature. The endoscope is advanced to a
desired implantation site along the gastrointestinal tract of the
patient 504. At this point, the physician uses a catheter to
puncture the mucosa of the gastrointestinal wall 506. A tunnel is
then bored in the submucosa at the desired lead implantation site
508.
[0060] A first end of the lead remains within the tunnel created in
the gastrointestinal wall. After boring the tunnel, the physician
then directs the lead through the remainder of the gastrointestinal
wall, exiting through the muscularis propria, adventitia, or
serosal side 510. Once through the entire thickness of the
gastrointestinal wall, the lead is navigated to a predetermined
endpoint within the abdomen 512. When the lead has been placed in
its operative position, the first end engages the gastrointestinal
musculature while the second end rests at the predetermined
endpoint within the abdomen. In one embodiment, the predetermined
endpoint is within the peritoneal cavity of the patient. In another
embodiment, the second end of the lead is navigated through the
anterior abdominal wall of the patient and the predetermined
endpoint is in the subcutaneous region of the abdomen.
[0061] In various embodiments, the physician's visualization of the
catheter and lead during implantation is assisted by differing
imaging techniques. In one embodiment, ultrasound imaging is used
in conjunction with visual imaging to help guide placement. In
another embodiment, radiologic imaging is used in conjunction with
visual imaging to help guide placement. In another embodiment,
fluoroscopy is used in conjunction with visual imaging to help
guide placement.
[0062] The above examples are merely illustrative of the many
applications of the system of the present invention. Although only
a few embodiments of the present invention have been described
herein, it should be understood that the present invention might be
embodied in many other specific forms without departing from the
spirit or scope of the invention. Therefore, the present examples
and embodiments are to be considered as illustrative and not
restrictive, and the invention may be modified within the scope of
the appended claims.
* * * * *