U.S. patent application number 13/113852 was filed with the patent office on 2011-09-15 for methods and devices for the surgical creation of satiety and biofeedback pathways.
Invention is credited to Michael E. Gertner.
Application Number | 20110224714 13/113852 |
Document ID | / |
Family ID | 46304728 |
Filed Date | 2011-09-15 |
United States Patent
Application |
20110224714 |
Kind Code |
A1 |
Gertner; Michael E. |
September 15, 2011 |
METHODS AND DEVICES FOR THE SURGICAL CREATION OF SATIETY AND
BIOFEEDBACK PATHWAYS
Abstract
Disclosed are devices and systems which to sense parameters
related to the mechanical forces imposed on devices implanted in
the stomach. The parameters of the system are further translated
into patient feedback systems to create satiety inducing pathways
in the stomach.
Inventors: |
Gertner; Michael E.; (Menlo
Park, CA) |
Family ID: |
46304728 |
Appl. No.: |
13/113852 |
Filed: |
May 23, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11153791 |
Jun 15, 2005 |
7946976 |
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13113852 |
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11125547 |
May 10, 2005 |
7670279 |
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11153791 |
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PCT/US05/09322 |
Mar 19, 2005 |
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11125547 |
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10974248 |
Oct 27, 2004 |
7255675 |
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PCT/US05/09322 |
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60556004 |
Mar 23, 2004 |
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60584219 |
Jul 1, 2004 |
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60603944 |
Aug 23, 2004 |
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Current U.S.
Class: |
606/191 |
Current CPC
Class: |
A61B 2017/0404 20130101;
A61B 2017/0409 20130101; A61B 2017/0445 20130101; A61B 17/0401
20130101; A61B 2017/0488 20130101; A61B 2017/0454 20130101; A61B
2017/00827 20130101; A61B 17/0487 20130101; A61B 2017/0417
20130101; A61B 2017/0456 20130101; A61B 17/29 20130101; A61F 5/0086
20130101; A61B 2017/0496 20130101; A61B 2017/0458 20130101; A61B
17/00234 20130101; A61B 2017/00398 20130101; A61B 2017/00871
20130101; A61B 2017/06052 20130101; A61F 5/0076 20130101; A61B
2017/0464 20130101; A61B 17/0469 20130101 |
Class at
Publication: |
606/191 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1. A device to treat obesity comprising: a restrictive balloon
adapted to circumscribe the stomach and which defines a restrictive
volume of the stomach; and an integral sensor located with the
balloon wherein the sensor is responsive to changes in the
restrictive volume of the stomach.
2. The device of claim 1, wherein a portion of the restrictive
balloon is attached to the abdominal wall.
3. The device of claim 2, wherein the restrictive balloon is
attached to the abdominal wall by an anchor.
4. The device of claim 1 further comprising a wireless transmitter
configured to transmit information from said integral sensor.
5. The device of claim 1 further comprising a system efferent
pathway with a first end and a second end; wherein the first end of
said system efferent pathway is attached to said device to treat
obesity and the second end of said system efferent pathway is
configured to be attached to a patient afferent pathway.
6. The device of claim 5 wherein said patient afferent pathway is a
visceral nervous pathway.
7. The device of claim 5 wherein said patient afferent pathway is a
vagal nerve pathway.
8. The device of claim 5 wherein said patient afferent pathway is a
layer of the stomach.
9. The device of claim 5 wherein said patient afferent pathway is a
cutaneous nervous pathway.
10. A method of inducing satiety in a patient comprising:
implanting a restrictive balloon to circumscribe the stomach of a
patient wherein the restrictive balloon defines a restricting
volume and wherein the restrictive balloon further comprises an
integral sensor to detect changes in the restricting volume;
detecting changes in a restricted volume defined by the restrictive
balloon; and transmitting the detected changes of the restricted
volume to a device efferent pathway and thence to a patient
afferent pathway for stimulation, wherein the stimulation induces
satiety in the patient.
11. The method of claim 10, wherein a portion of the restrictive
balloon is attached to the abdominal wall.
12. The method of claim 11, wherein the restrictive balloon is
attached to the abdominal wall by an anchor.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of Non-Provisional
patent application Ser. No. 11/153,791 by Michael Gertner, M.D.,
entitled "Methods and Devices for the Surgical Creation of Satiety
and Biofeedback Pathways" filed Jun. 15, 2005, which is a
continuation-in-part of U.S. Non-Provisional patent application
Ser. No. 11/125,547 by Michael Gertner, M.D., entitled
"Percutaneous Gastroplasty" filed May 10, 2005 now U.S. Pat. No.
7,670,279 issued on Mar. 2, 2010, which is a continuation-in-part
of International Patent Application No. PCT/US05/09322 by Michael
Gertner, M.D., filed Mar. 19, 2005, designating the United States,
entitled "DEVICE AND METHODS TO TREAT A PATIENT," which is a
continuation-in-part of U.S. Non-Provisional patent application
Ser. No. 10/974,248 by Michael Gertner, M.D. filed Oct. 27, 2004,
entitled "DEVICES AND METHODS TO TREAT A PATIENT," now U.S. Pat.
No. 7,255,675 issued on Aug. 14, 2007, which claims priority to
U.S. Provisional Patent Application Ser. No. 60/556,004 filed Mar.
23, 2004 by Michael Gertner, M.D., entitled "BARIATRIC DEVICES AND
IMPLANTATION METHODS," to U.S. Provisional Patent Application Ser.
No. 60/584,219 filed Jul. 1, 2004 by Michael Gertner, M.D.,
entitled "DEVICES AND METHODS FOR PERCUTANEOUS GASTROPLASTY," to
U.S. Provisional Patent Application Ser. No. 60/603,944 filed Aug.
23, 2004 by Michael Gertner, M.D., entitled "DEVICES AND METHODS TO
TREAT MORBID OBESITY," all of which are herein incorporated by
reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to methods and apparatus for
implanting devices in the walls of organs or vessels, including
devices to appose the walls of the stomach and blood vessels.
[0004] 2. Description of the Related Art
[0005] Obesity is a public health problem of extreme national and
international importance. There are an estimated 60 million obese
adults and 2 million obese adolescents in the United States as of
2004. By some estimates, there are 1 billion obese individuals
worldwide. Indeed, recent reports estimate that over there are over
60 million obese individuals in China, a 10-fold increase since
2000. Obesity affects the life quality and productivity of those
effected and leads to long-term health related complications such
as diabetes and heart disease. Some researchers estimate that if
the obesity epidemic is not brought under control, it could quickly
overwhelm societal resources.
[0006] To date, surgery is the only proven method for inducing
substantial weight loss. The mechanism behind the success of
surgery is, in many cases, not known because obesity is such a
complex, multifactorial disease. Some researchers propose that
surgery does no more than provide biofeedback for appetite
retraining. Other researchers maintain that surgery alters the
physiology of the patient such that satiety is induced earlier or
fewer nutrients are absorbed. Nonetheless, all researchers agree
that long-term weight loss is only possible by surgical means.
[0007] Over the past four decades, there have been numerous
surgical procedures and devices developed to those who suffer from
morbid obesity. In general, there are two physiologic components of
all past and current procedures: malabsorption and mechanical
restriction/volume reduction.
[0008] Many of the procedures performed in the past have proven to
be impractical, dangerous, and/or detrimental to patient health and
are now of historical importance only. One example of a failed
procedure is the jejuno-ileo bypass in which a malabsorptive state
was created through the bypass of a large portion of the intestine
through the creation of a surgical anastomosis between the jejunum
and the ileum. While patients initially lost a great deal of
weight, liver failure or liver damage occurred in over one-third of
the patients which necessitated reversal of the surgical
procedure.
[0009] One of the first restrictive type surgical procedures was
the so-called "stomach stapling" operation in which a row of
horizontal staples was placed across the upper stomach and then
several staples were removed from the staple line to create an
opening, the "os" for a small amount of food, but not too much
food. This procedure was mostly restrictive, leading to an early
feeling of satiety. This surgery was abandoned because 70%-80% of
patients had inadequate weight loss due to staple line dehiscence
(i.e. the staples pulled through the stomach wall). A procedure to
stabilize the staple line was performed by Smith et. al. (Lindsay
B. Smith; Modification of the Gastric Partitioning Operation For
Morbid Obesity. Am. J. Surgery 142, December 1981) in which the
staple line was buttressed in the region where the staples were
removed using teflon pledgets with sutures passing through the
middle of the pledgets. The purpose of the pledgets was to buttress
the suture and distribute the load across the suture to the
pledget, thereby preventing the suture from pulling through the
stomach and therefore stabilizing the os. The outcomes showed that
the suture buttress was able to prevent the suture from tearing
through the stomach wall.
[0010] The Roux-en-Y (The Roux) bypass operation has become the
most commonly performed surgical procedure to treat the morbidly
obese in the United States. It combines a small degree of
malabsorption with a 90% reduction in the volume of the stomach. In
the United States, 150,000 Roux procedures were performed in the
year 2004. This number is expected to rise to 500,000 procedures by
2007. The procedure actually has been performed since the late
1970's but has evolved substantially over the past three decades
into a relatively safe and effective procedure; indeed, the
long-term data is very good. The advent of laparoscopic surgery and
hence the laparoscopic Roux-en-Y bypass in combination with
excellent follow-up results from the open procedure are reasons for
the proliferation of the Roux procedure.
[0011] Despite the efficacy of the Roux procedure and the recent
laparoscopic improvements, it remains a highly invasive procedure
with substantial morbidity, including a 1-2% surgical mortality, a
20-30% incidence of pulmonary morbidity such as pneumonia,
pulmonary embolism, etc., and a 1-4% chance of leak at the
anastomotic site which can result in a spectrum of consequences
ranging from an extended hospital stay to death. Furthermore, it is
not a good option for adolescents in whom the long-term
consequences of malabsorption are not known. In addition, many
patients resist such an irreversible, life altering procedure.
[0012] The Roux procedure requires general anesthesia and muscle
paralysis which, in the morbidly obese population, is not of small
consequence. There is also a substantial rate of anastomotic
stricture which results in severe lifestyle changes for patients.
As an example, many patients are forced to vomit after meals.
Furthermore, although minor when compared to previous malabsorptive
(e.g. jejuno-ileal bypass) procedures, the malabsorption created by
the Roux-en-Y can dramatically affect the quality of life of
patients who undergo the procedure.
[0013] Recently, minimally invasive procedures and devices which
create a feeling of early satiety have been introduced into the
marketplace in an attempt to address some of the issues above. The
LAP-BAND.TM. is a band which encircles the stomach at the region of
the fundus-cardia junction; it is a restrictive procedure similar
to stomach stapling. It requires general anesthesia, a
pneumoperitoneum, muscle paralysis, and extensive dissection of the
stomach at the level the gastroesophageal junction. Although less
invasive than the Roux procedure and potentially reversible, the
LAP-BAND.TM. is nonetheless quite invasive. It also does not reduce
the volume of the stomach and some patients report a feeling of
hunger much of the time. In addition, long-term follow-up reveals
that the banding procedure results in many complications. In a
recently published article (Camerini et al. Thirteen Years of
Follow-up in Patients with Adjustable Silicone Gastric Banding for
Obesity: Weight Loss and Constant Rate of Late Specific
Complications. Obesity Surgery, 14, 1343-1348), the authors
reported a 60% prevalence of late band removal secondary to
complications such as erosion, slippage of the band, infection, or
lack of effectiveness. Nonetheless, the LAP-BAND.TM. as a procedure
is becoming very popular across the world as it is perceived to be
a less invasive and reversible procedure. The weight loss in
long-term trials is considered adequate by some and inadequate by
many; across the various studies, the average weight loss is
approximately 40% of excess body weight (see below).
[0014] Other procedures which have been tried in the past and which
offer varying degrees of weight loss include several variations of
the original "gastroplasty" procedures. These procedures represent
an evolution of the so-called "stomach stapling" procedure
discussed above. These procedures were attempted prior to and
concomitant with the evolution of the Roux-en-Y. They became
popular (despite potentially offering less weight loss than the
Roux) because of their substantially less invasive nature and
possible reversibility.
[0015] One such example is called the vertical banded gastroplasty,
or VBG, which again, created a restricting "os" for food. In the
VBG, the border of the "os" is the lesser curvature of the stomach
which is less apt to dilate than the fundus region of the stomach.
Furthermore, the procedure completely excludes the fundus which is
thought to easily dilate and in fact, is physiologically
"programmed" to dilate during meals . . . so-called "receptive
relaxation." One issue with the VBG is that, as practiced today, it
is not reversible, nor is it adjustable, and it is difficult to
perform laparoscopically. As in the horizontal gastroplasty, the
VBG utilizes standard staplers which, as in the horizontal
gastroplasty, are unreliable when applied to the stomach. In the
case of the VBG, the row of staples runs parallel to the lesser
curvature of the stomach.
[0016] A recent, prospective, randomized trial, compared the VBG to
the adjustable banding procedure and found that the VBG was
overwhelmingly superior to the banding procedure (Morino et. al.
Laparoscopic Adjustable Silicone Gastric Banding Versus Vertical
Banded Gastroplasty in Morbidly Obese Patients. Annals of Surgery.
Vol. 238 (6) pps. 835-842). Twenty five percent of the patients in
the banding group returned to the operating room whereas there were
no returns to the operating room in the gastroplasty group. The
degree of weight loss was close to 60% of excess body weight after
three years in the gastroplasty group and closer to 40% of excess
body weight in the banding group. Although in this study, the VBG
was successfully performed laparoscopically, the laparoscopic VBG
procedure is in fact, difficult to perform, because the procedure
is not standardized and a "tool box" does not exist for the surgeon
to carry out the procedure; furthermore, the procedure is not a
reversible one and relies on the inherently unreliable stapler
systems. A recent meta-analysis and systematic review (Buchwald,et.
al. Bariatric Surgery A Systematic Review and Meta-analysis; JAMA
vol. 292, no 14. pps 1724-1737) indicated that vertical
gastroplasty (avg. excess weight loss of 68.2%) is superior to
adjustable banding (avg excess weight loss of 47.5%) and gastric
bypass (avg excess weight loss of 61.6%).
[0017] The Magenstrasse and Mill (M&M) procedure is an evolving
gastroplasty technique wherein the greater curvature of the stomach
is separated (stapled and cut) from the path of food, leaving a
tube of stomach, the Magenstrasse, or "street of the stomach,"
which is comprised of the lesser curvature. This procedure is
similar to the VBG except that the longitudinal staple line of the
stomach extends further along the lesser curvature and into the
antrum. The theory behind leaving the antral "mill" is that it will
continue to serve its normal function of mixing, grinding,
retropulsion, and well-orchestrated expulsion of chyme into the
duodenum. An authoritative study on the operation is incorporated
herein by reference (Johnston et. al. The Magenstrasse and Mill
Operation for Morbid Obesity; Obesity Surgery 13, 10-16).
[0018] In summary, the vertical gastroplasty procedure appears to
be superior to the banding procedure. However, the vertical
gastroplasty procedure is not easily performed laparoscopically and
furthermore, it is not reversible. Therefore, a need exists to
standardize the vertical banded gastroplasty and create a safer
procedure which is also easy to perform, is durable and is
reversible.
[0019] The intragastric balloon is not a new concept. The
intragastric balloon is meant to displace volume within the stomach
such that a smaller volume of food leads to an earlier feeling of
satiety. Currently, intragastric balloons on the market are not
fixed to the stomach. As a consequence, the intragastric balloons
lead to complications such as obstruction and mucosal erosion. As a
consequence, the balloons are removed after a maximum of six
months. In a prospective, non-randomized, unblinded study (Sallet
et. al. Brazilian Multicenter Study of the Intragastric Balloon;
Obesity Surgery, 14, 991-998), the average excess weight loss was
48.3% after 1 year. However, the incidence of nausea and vomiting
was 40% and epigastric pain was 20%; balloon impaction occurred in
0.6% of patients. A balloon which is fixed to the wall of the
stomach could potentially improve the intragastric balloon device
and allow longer-term implantation.
[0020] More recently, there has been an effort to develop even less
invasive devices and procedures which do not involve incisions at
all. For the most part, these procedures are performed from within
the stomach with an endoscope and by a physician with a high degree
of endoscopic skill. For example, U.S. Pat. No. 6,558,400 describes
methods and devices to create partitions in the stomach. Anchors or
staplers applied through an endoscope from within the stomach are
used to accomplish the partitions. Similarly, U.S. Patent
Application Publication No. 2004/0122456 describes another set of
methods and devices to reduce the volume of the stomach. Expandable
anchors are deployed both on the anterior and posterior wall of the
stomach using an endoscope. Flexible sutures are brought out of the
patient's mouth and the sutures are crimped together within the
stomach in order to bring the walls of the stomach closer together.
Patent application WO2004/004542 describes a device which is
advanced through an endoscope and grasps or applies suction to a
fold of mucosa to apply anchors through the mucosal and serosal
layers of the stomach.
[0021] Endoscopic procedures to manipulate the stomach are time
consuming because of the technical difficulty of the endoscopy;
they also require a large endoscope through which many instruments
need to be placed for these complex procedures. Due to the large
size of the endoscope, patients typically will require general
anesthesia, which Rinks the "non-invasive" aspects of the
procedure. Furthermore, the procedures require advanced endoscopic
skill which would need to be acquired by most endoscopic
practitioners. Such skill adaptation can take a significant amount
of time, which will limit adoption of the procedure by the
physician community. A further issue is that there is a limitation
on the size of the anchors and devices which can be placed because
the endoscope has a maximum size.
[0022] Percutaneous Endoscopic Gastrostomy (PEG) refers to a
procedure in which a gastrocutaneous tract is created using a
percutaneous procedure (see below for definition). A recent update
of the procedure can be found on the Society of American
Gastrointestinal Endoscopic Surgeons (SAGES) website, and is
incorporated herein by reference. Briefly, the procedure involves
insufflation of the stomach with and under visualization with an
endoscope. A small incision is made in the skin and a needle is
advanced into the stomach (the stomach sits just under the
abdominal wall when insufflated) under endoscopic visualization. A
feeding tube is then placed over the needle to create a
gastrocutaneous tract with the feeding tube inside the tract. The
feeding tube is secured with an external bolster to creates a
tubular tract from outside the patient through the skin of the
abdominal wall and residing inside the stomach. Over the ensuing
weeks, a permanent tract evolves between the stomach mucosa and
epithelium of the skin, after which, the bolster can be removed
without consequence. When the feeding tube is to be removed, the
gastrocutaneous tract will close on its own as food will
preferentially be delivered antegrade (the path of least
resistance) to the duodenum, thereby allowing the tract to
heal.
SUMMARY OF THE INVENTION
[0023] Several embodiments provided herein relate to devices and
methods of treating obesity. In some embodiments, a device to treat
obesity is provided including a restrictive balloon adapted to
circumscribe the stomach and which defines a restrictive volume of
the stomach; and an integral sensor located with the balloon
wherein the sensor is responsive to changes in the restrictive
volume of the stomach. In one aspect, a portion of the the
restrictive balloon is attached to the abdominal wall. In the same
aspect, the restrictive balloon is attached to the abdominal wall
by an anchor. In another aspect, the device further includes a
wireless transmitter configured to transmit information from said
integral sensor. In a further aspect, the device further includes a
system efferent pathway with a first end and a second end, wherein
the first end of said system efferent pathway is attached to said
device to treat obesity and the second end of said system efferent
pathway is configured to be attached to a patient afferent pathway.
In the same aspect, the patient afferent pathway is a visceral
nervous pathway. In the same aspect, the patient afferent pathway
is a vagal nerve pathway. In the same aspect, the patient afferent
pathway is a layer of the stomach. In the same aspect, the patient
afferent pathway is a cutaneous nervous pathway.
[0024] Several embodiments relate to a method of inducing satiety
in a patient including implanting a restrictive balloon to
circumscribe the stomach of a patient wherein the restrictive
balloon defines a restricting volume and wherein the restrictive
balloon further comprises an integral sensor to detect changes in
the restricting volume; detecting changes in a restricted volume
defined by the restrictive balloon; and transmitting the detected
changes of the restricted volume to a device efferent pathway and
thence to a patient afferent pathway for stimulation, wherein the
stimulation induces satiety in the patient. In one aspect, a
portion of the restrictive balloon is attached to the abdominal
wall. In another aspect, the restrictive balloon is attached to the
abdominal wall by an anchor.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIGS. 1A-1E are perspective views of embodiments of the
posterior anchor and connector.
[0026] FIGS. 1F and 1G are side views of an inflatable embodiment
of posterior anchor and connector.
[0027] FIGS. 1H, 1I, and 1J are views of suture-connector-posterior
anchor combinations in which the connector is separable from the
posterior anchor.
[0028] FIG. 1K is a view of a connector-anchor combination in which
the length between two anchors is adjustable.
[0029] FIGS. 2A and 2B are a perspective view and top view of one
embodiment of an anterior anchor, respectively.
[0030] FIGS. 2C and 2D are side sectional views of the embodiment
of the anterior anchor of FIGS. 2A and 2B, taken along the line B-B
in FIG. 2B, in its deployed and reduced profile configuration,
respectively.
[0031] FIGS. 2E and 2F are side sectional views of another
embodiment of an anterior anchor, taken along the same line as
FIGS. 2C and 2D, in its deployed and reduced profile configuration,
respectively.
[0032] FIGS. 2G is a perspective view of an inflatable embodiment
of an anterior anchor.
[0033] FIGS. 2H and 2I are side sectional views of the embodiment
of the anterior anchor of FIG. 2G, taken along the line D-D in FIG.
2G, in its deployed and reduced profile configuration,
respectively.
[0034] FIG. 3A is a perspective view of another embodiment of an
anterior anchor.
[0035] FIGS. 3B and 3C are perspective views of the embodiment of
the anterior anchor shown in FIG. 3A in its reduced profile and
deployed configuration, respectively.
[0036] FIG. 3D is a perspective view of another embodiment of an
anterior anchor.
[0037] FIGS. 4A and 4A' are a side and blow-up view, respectively,
of one embodiment of a tissue grasping instrument with the distal
end in its open configuration.
[0038] FIGS. 4B and 4B' are a perspective and blow-up view,
respectively, of the tissue grasping instrument of FIG. 4A with the
distal end in its closed configuration.
[0039] FIGS. 4C and 4C' are a perspective and blow-up view,
respectively, of another embodiment of the tissue grasping
instrument with the distal end in its closed configuration.
[0040] FIGS. 5A is a side view of one embodiment of an anchor
implantation instrument.
[0041] FIG. 5B is a perspective view of the distal end of the
anchor implantation instrument of FIG. 5A and an anterior anchor
and connector.
[0042] FIG. 5C is a side sectional view of the distal end of the
anchor implantation instrument of FIGS. 5A and 5B, taken along line
C-C in FIG. 5B, with the anterior anchor in its reduced profile
configuration.
[0043] FIG. 6A illustrates the first step in one embodiment of a
method of reducing the volume of the stomach. Shown is a side
sectional view of a patient's abdomen with the instrument of FIG. 4
inserted into the patient's abdomen through a laparoscopic
port.
[0044] FIG. 6B illustrates the next step in one embodiment of a
method of reducing the volume of the stomach. Shown is a side
sectional view of a patient's abdomen with the instrument of FIG. 4
grasping the posterior wall of the stomach and a needle being
inserted into the potential space of the lesser peritoneal sac.
[0045] FIG. 6C illustrates the next step in one embodiment of a
method of reducing the volume of the stomach. Shown is a side
sectional view of a patient's abdomen with the instrument of FIG. 4
grasping the posterior wall of the stomach and a posterior anchor
and connector deployed in the expanded potential space of the
lesser peritoneal sac.
[0046] FIG. 6D illustrates the next step in one embodiment of a
method of reducing the volume of the stomach. Shown is a side
sectional view of a patient's abdomen with a posterior anchor and
connector deployed in the expanded potential space of the lesser
peritoneal sac, with the connector passing out of the patient's
abdomen through a laparoscopic port.
[0047] FIG. 6E illustrates an alternative step and device to place
the posterior anchor in which the posterior anchor is brought
behind the stomach before the connector is attached.
[0048] FIG. 7A illustrates the next step in one embodiment of a
method of reducing the volume of the stomach. Shown is a side
sectional view of a patient's abdomen with the instrument of FIG.
5C placing an anterior anchor in the patient's abdomen adjacent to
the anterior wall of the stomach.
[0049] FIG. 7B illustrates the next step in one embodiment of a
method of reducing the volume of the stomach. Shown is a side
sectional view of a patient's abdomen with an anterior anchor in
its deployed configuration on the connector, with the anterior and
posterior walls of the stomach urged together.
[0050] FIG. 7C illustrates the next step in one embodiment of a
method of reducing the volume of the stomach. Shown is a side
sectional view of a patient's abdomen after the connector has been
cut flush with the anterior anchor.
[0051] FIG. 8A illustrates an embodiment of a method of reducing
the volume of the stomach, Shown is a side sectional view of a
patient's abdomen after two posterior anchors and connectors have
been deployed adjacent to the posterior wall of the stomach, with
the connectors passing out of the patient's abdomen through
laparoscopic ports.
[0052] FIG. 8B shows the connectors of FIG. 8A with clamps placed
on the connectors outside the patient's body to temporarily hold
the connectors in a test position.
[0053] FIG. 9 is a perspective view showing three transgastric
fastening assemblies deployed longitudinally in a patient's
stomach.
[0054] FIG. 10A illustrates one embodiment of a method for
deploying a volume displacing device in the stomach. Shown is a
side sectional view of a patient's abdomen after an uninflated
balloon anchor has been inserted inside the patient's stomach with
a connector passing out of the stomach, through the anterior
stomach wall, and through a laparoscopic port.
[0055] FIG. 10B illustrates one embodiment of a method for
deploying a volume displacing device in the stomach. Shown is a
side sectional view of a patient's abdomen with the balloon anchor
in its deployed position, held in place by an anterior anchor and
connector.
[0056] FIG. 11A illustrates a volume displacing device which
resides outside the stomach and is shown in an undeployed
state.
[0057] FIG. 11B illustrates a volume displacing device which
resides outside that stomach and is shown in a deployed state and
attached to the abdominal wall and with an anterior anchor and
connector.
[0058] FIG. 11C illustrates a volume displacing device which
resides outside the stomach and is fixed to the anterior wall of
the stomach and to the abdominal wall with an anterior anchor and
connector.
[0059] FIG. 12 illustrates another step in the laparoscopic method
of placing a device in the stomach.
[0060] FIG. 13 illustrates another step in the laparoscopic
procedure in which the anterior anchor is urged toward the
posterior anchor over a connector.
[0061] FIG. 14 illustrates another step in the laparoscopic
procedure in which the anterior and posterior walls of the stomach
are urged together.
[0062] FIG. 15a illustrates the initial retrogastric step in the
laparoscopic procedure.
[0063] FIG. 15b depicts a horizontal row of transgastric anchors
and connectors after placement in the stomach.
[0064] FIG. 16 depicts anchors of the present invention being used
to secure an endoscopically placed gastric implant.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Anatomy of the Stomach
[0065] The region behind the stomach is referred to as the lesser
peritoneal sac. It is a potential space between the retroperitoneum
and the posterior wall of the stomach. To the left of the midline,
the posterior wall of the stomach is generally free from the
peritoneal surface of the retroperitoneum. To the right of the
midline, the posterior wall of the stomach is more adherent to the
retroperitoneum although the adherence is generally loose and the
adhesions can be broken up rather easily with gentle
dissection.
[0066] The stomach is comprised of several layers. The inner layer
is the mucosa. The next layer is the submucosa followed by the
outer muscular layers. Surrounding the muscular layers is the
serosal layer. This layer is important with regard to implants and
healing because it is the adhesive layer of the stomach; that is,
it is the layer which, when breached, heals with scar tissue
formation. Implants adhering to this layer are less likely to
migrate into the stomach. Reference to "stomach wall" or "wall of
the stomach" as used herein include the entire thickness of the
stomach, including the mucosa, submucosa, muscular layers, and
serosa. The "anterior wall of the stomach" is the portion of the
stomach closest to the muscular abdominal wall and the "posterior
wall of the stomach" is the part of the stomach closest to the
retroperitoneum.
[0067] "Transgastric fastening assembly" or "fastening system"
refers to a permanent or semi-permanent implant and comprises at
least one posterior anchor, at least one anterior anchor, and a
connector to couple the posterior and anterior anchors. The
"connector" can refer to any means of connection including but not
limited to a material connection, an electromagnetic connection, or
a chemical connection. As used herein, a "connector" is a coupler
or linker used to materially connect the anterior and posterior
anchors. As used herein, the "posterior anchor" is the anchor in a
preferred embodiment which is adjacent to the posterior wall of the
stomach when deployed. The "anterior anchor" is the anchor in a
preferred embodiment which is approximated to the anterior wall of
the stomach when deployed.
[0068] As used herein and when referring to portions of a surgical
instrument, "proximal" refers to the end of the instrument which is
closest to the surgeon when the instrument is used for its intended
purpose, and "distal" refers to the end of the instrument which is
closest to the patient when the instrument is used for its intended
purpose. When used to refer to the gastrointestinal tract,
"proximal" is toward the mouth and "distal" is toward the anus.
[0069] "Laparoscopic procedure" broadly refers to procedures which
require pneumoperitoneum and general anesthesia. "Percutaneous
procedure" broadly refers to surgeries which do not require general
anesthesia or pneumoperitoneum. These broad terms are mutually
exclusive for the purposes of the ensuing invention because the
respective procedures require different levels of patient
preparation and peri-operative treatments. In some descriptions,
the terminology "percutaneous means" is used which generically
refers to placing a surgical instrument through the skin of a
patient and using the surgical instrument to accomplish a surgical
task; in this more generic case, "percutaneous means" can be used
with or without laparoscopy. Similarly, "laparoscopic means"
generically refers to procedures performed under the guidance of an
internal camera; in this more generic sense, laparoscopy can be
used with or without percutaneous methodology though in most cases
percutaneous methodology is preferred.
Structures
Transgastric Fastening Assembly
[0070] Referring to FIGS. 1A and 1B, one embodiment of the
posterior anchor 14 and connector 12 are shown in a deployed
configuration (FIG. 1A), and reduced profile configuration (FIG.
1B). The connector 12 is preferably made of a flexible,
biocompatible polymer, but it can be made from various kinds of
suitable biocompatible materials known to those of skill in the art
including metals, such as titanium and platinum, metal alloys, such
as stainless steel, nickel-titanium, and cobalt-chromium, man-made
polymers, such as polyurethane, silicone elastomers, polyglycolic
acid, polylactic acid, poly (.epsilon.-caprolactone),
polyvinylidene fluoride (PVDF), PTFE, FEP, polypropylene, or
natural fibers such as silk; bioartificial materials include
allogenic and xenogenic collagen based products. These materials
can be used singly or in combination. For example, one portion of
the connector may be bioabsorbable and another portion of the
connector may be permanent. The connector 12 can vary in thickness,
shape, and rigidity. For example, in the embodiment shown in FIG.
1A, the connector 12 is substantially rod-shaped, with a circular
cross-section, and is flexible. Those of skill in the art will
recognize that the cross-section of the connector can be any of a
number of shapes, such as square, hexagonal, oval, etc. In other
embodiments, the connector 12 is thin and flexible, such as a
surgical suture, and in still others it is rigid. The connector can
have a thickness ranging from 100 microns (e.g. suture) to several
millimeters depending on the application. Although a single
connector is depicted as being attached to the posterior anchor,
those skilled in the art will recognize that more than one, or
several connectors can be connected to the anchor at different
points on the anchor or as a combination attached to one point on
the anchor (e.g. a bundle).
[0071] In a preferred embodiment, the posterior anchor 14 is made
from a biocompatible, radio-opaque or magneto-opaque semi-rigid
polymer; it can also be made from various kinds of suitable
materials known to those of skill in the art including metals,
metal alloys, plastics, natural materials or combinations thereof
as discussed above in relation to the connector 12. In some
embodiments, the anchor is made from a conductive material and in
other embodiments, the anchor is made from a combination of
conducting, non conducting, and/or semi-conducting materials. The
posterior anchor 14 can be solid, or alternatively, can be porous,
mesh-like, lattice-like, or umbrella-like. In some embodiments, the
anchor contains a potential space on the inside which can be
expanded by a fluid (e.g. gas or liquid). In a preferred
embodiment, the posterior anchor is porous or has a porous mesh
attached to it to encourage fibrous ingrowth such that it becomes
permanently attached to the stomach or intestinal wall. Coatings
can be added to the anchor to encourage tissue ingrowth; of course,
such coatings do not limit the ability for the interior of the
anchor to be a potential space for expansion by a fluid. In other
embodiments, the posterior anchor is solid and/or treated to
discourage tissue ingrowth (e.g. with a silicone coating). In other
embodiments, the posterior anchor has a xenograft or allograft
material attached to the anchor. In a preferred embodiment, the
posterior anchor 14 is disc-shaped, but those of skill in the art
will recognize that other embodiments are possible, such as those
shown in FIGS. 1C and 1D, or disclosed in U.S. Patent Application
Publication No. 2004/0122456 which is herein incorporated by
reference; note particularly the description of anchor structures.
The posterior anchor, in other embodiments, can be rectangular or
diamond shaped. The posterior anchor can also be bioabsorbable in
whole or in part in some embodiments. The largest dimension of the
posterior anchor can range from about 5 mm to about 10 cm depending
on the application and the manner in which it is implanted (see
below). In the case where the posterior anchor is a disc shape, the
diameter is considered the largest dimension.
[0072] In the embodiment shown in FIGS. 1A and 1B, the connector 12
is fastened to the posterior anchor 14 at an attachment point 16
which is preferably a permanent, e.g. welded or molded, connection.
Such a weld or connection can comprise, for example, a thermoformed
polymer, a metallic weld, or a molded or other integral structure.
In a preferred embodiment, a biocompatible thermoformed polymer is
used because of its flexibility and ability to yield to the
continuous motion of the stomach. More preferably, the connector
and posterior anchor are produced as a single, continuous structure
(e.g. through an injection molding process).
[0073] Other suitable means of fastening the connector to the
posterior anchor are also contemplated and do not necessarily
result in a connector and posterior anchor becoming permanently
attached. For example, in one embodiment shown in FIG. 1C, one end
of the connector is passed through a hole 20 near the center of the
posterior anchor 22, and a stop 24, such as a knot or enlarged
molded region, is formed on the end of the connector to prevent its
passage back through the hole in the posterior anchor. In this
embodiment, the posterior anchor 22 can be free to move along the
length of the connector 26, but is prevented from being removed
from one end of the connector by the stop 24.
[0074] In the embodiment shown in FIGS. 1A and 1B, the posterior
anchor 14 preferably has a deployed configuration (FIG. 1A), and
reduced profile configuration (FIG. 1B). The posterior anchor 14
can be deformed to a folded configuration wherein its profile is
reduced to facilitate insertion of the anchor through the walls of
the stomach or other tissue as described in more detail below. In
one embodiment, the posterior anchor 14 is made of a semi-flexible
material having shape memory, so that once the anchor is deployed
within the patient, it will return to its original shape shown in
FIG. 1A, preventing it from being easily pulled back through the
tissue. Preferably, the posterior anchor is inflatable in place of,
or in addition to, having shape memory, which allows for a much
larger deployed profile relative to its undeployed profile (see
below). In some embodiments, the posterior anchor contains an
intrinsic magnetic, ferromagnetic, or paramagnetic material.
[0075] FIGS. 1D and 1E show an alternative embodiment of the
posterior anchor 30 and connector 32 in a deployed configuration
(FIG. 1D), and a reduced profile configuration (FIG. 1E). In this
embodiment, the posterior anchor 30 is elongated, having major and
minor dimensions, and preferably having a rod or bar shape. By
aligning the connector 32 substantially parallel to the posterior
anchor 30, its profile is reduced to facilitate insertion of the
anchor through the walls of the stomach or other tissue. When the
anchor leaves its surrounding sheath (see below), tension on the
connector 32 in the direction of the arrow in FIG. 1E will urge the
posterior anchor 30 into a substantially perpendicular orientation
relative to the connector 32, as shown in FIG. 1D, preventing it
from easily being pulled back through the tissue. The connection
between the posterior anchor 30 and the connector 32 can be hinged.
Alternatively, the connector 32 can be made of a semi-rigid
material which is permanently connected or welded to the posterior
anchor 30. If the connector is deformed to a bent position, shown
in FIG. 1E, it will return to its original straight shape shown in
FIG. 1D once the anchor is deployed within the patient, preventing
the posterior anchor from easily being pulled back through the
tissue. This anchor 30 can be inflatable as well, which allows for
a much larger deployed profile relative to its undeployed
profile.
[0076] In a preferred embodiment, shown in FIGS. 1F and 1G, the
posterior anchor is inflatable. The anchor has an inflatable
disc-shaped body 34 which is readily deformable when in its reduced
profile (i.e., uninflated) configuration as shown in FIG. 1F. In
the preferred embodiment, the posterior anchor body 34 is
disc-shaped, but those of skill in the art will recognize that
other embodiments are possible, such as those shown in FIGS. 1C and
1D, or in which the inflatable anchors are square shaped,
rectangular, or amorphous, or have a shape disclosed in U.S. Patent
Application Publication No. 2004/0122456 which is herein
incorporated by reference; note particularly the description of
anchor structures. The body can be inflated with a substance
delivered through a hollow connector 35. When the interior space 36
of the anchor body is inflated, the anchor assumes its deployed
configuration shown in FIG. 1G. Once the body is inflated, it can
become substantially less compliant yet remain soft and
pliable.
[0077] The inflatable posterior anchor can have a valve 38 located
between the anchor body 34 and the connector 35. Alternatively, the
valve is located in the portion of the connector located outside
the patient, the valve (e.g. stopcock type valve) being controlled
by the operator until the anterior anchor is placed (see below). In
this alternative embodiment, the filling substance is trapped in
the posterior anchor after the anterior anchor is deployed and the
connector is cut and sealed, preferably flush with the anterior
anchor (see below). The filling substance can be a gas, liquid, or
material which changes phase with time (i.e. it may harden, cure,
polymerize, or become a gel with time). Preferably, the surface of
the posterior anchor adjacent to the posterior wall of the stomach
has a mesh fixed to it to encourage tissue ingrowth. In some
embodiments, part, or all of the anchor material is comprised of a
biodegradable material.
[0078] FIG. 1H depicts another embodiment of the current invention.
The posterior anchor 37 and the connector 39 are separable in this
embodiment. A second connector 33 is disposed within the first
connector 39. The second connector can be one or more sutures. This
fastening assembly would be used in a laparoscopic procedure where
the connector 39 would be placed through an organ before engaging
the posterior anchor 37. In some embodiments, the posterior anchor
can be as large as the width of the organ (e.g. 8-10 cm in the case
when the organ is the stomach). In some embodiments, the anchor 37
can be as small as 5 mm or 1 cm. The anchor 37 can also be adapted
to accommodate several connectors rather than one connector at a
time. The first connector 39 is adapted to engage the posterior
anchor 37 after passing through tissue (e.g. the stomach). In one
embodiment, the first connector has an inner diameter with a second
connector (e.g. a suture) traveling through its lumen. After
contact between the outer connector 39 and the posterior anchor 37,
the outer connector 39 is removed, leaving the inner connector 33
(e.g. the suture) attached to the posterior anchor 37 (FIG. 1J).
The connection of the suture to the posterior anchor is
accomplished by any mechanical means well known to those skilled in
the art.
[0079] FIG. 1K depicts another embodiment of the current invention
in which the connector 47 in this embodiment is configured so that
its length is adjustable. In this embodiment, the connector is
split (e.g. two sutures are used). The housing 45 is attached to
one half of the connector 47 and this half of the connector is
attached to the posterior anchor 49. Within housing 45, the
connector 47 can be shortened (and the tension between the two
anchors increased) by turning inner cylinder 48 which changes the
distance (and the tension on the connector) between the two anchors
49,51. Such adjustment can be done with an endoscope and can be
done after (days, months, years) implantation of the fastening
system within an organ such as the stomach.
[0080] Although FIGS. 1a-k depict a single connector contacting the
posterior anchor, those skilled in the art will recognize that more
than one connector can be used to contact the posterior connector.
The more than one connector can be placed in any arrangement along
the posterior anchor (e.g. in a row, in a pattern along the
perimeter, or concentrated in the center). The more than one
connector can be bundled and attached in one place on a second
anchor or in multiple point on a second anchor.
[0081] In any of the embodiments above, the connector can serve as
a sensor to detect the tension imposed on it by the two fasteners
moving in opposite directions. As discussed below, the connector
(sensor) serves as the afferent (sensing) limb of a feedback loop.
The efferent (outgoing) pathway of the feedback loop can be an
electrical lead which communicates with and stimulates a neural
pathway such as the vagus nerve or a sympathetic pathway such as
the celiac plexus. When these neural pathways are stimulated, a
feeling of satiety is created in a patient. Alternatively, the
efferent limb of the feedback loop is an electrical lead which
communicates with a cutaneous stimulator. In this embodiment, the
feedback to the patient is not a satiety signal but a cutaneous
feedback signal. The connector can take the form of a strain gauge
in which a potential is generated which is proportional to the
tension applied to it. In one embodiment, the strain measurement in
the connector is transmitted wirelessly to the effector limb of the
circuit or to an external receiver. In other embodiments, the
strain measurement is transmitted through a wired circuit.
[0082] The algorithm between the afferent and efferent limbs can be
a simple one in which the efferent limb has an on or off status
depending on the level of stimulation from the afferent limb.
Alternatively, the relationship between the afferent and efferent
limbs is non-linear. For example, as the strain increases, the
efferent signal increases two- three- or fold. If the strain
increases further, the efferent signal increases ten-fold.
[0083] FIGS. 2A (perspective view) and 2B (plan view) show an
embodiment of the anterior anchor 40. The anterior anchor has a
disc-shaped body 42 with a hole or other passageway 44
substantially in the middle of the body. Although the hole is shown
in the center of the anchor, those skilled in the art will
recognize that the hole can be placed anywhere along the face of
the anterior anchor and/or more than one hole can be created in the
anchor. Two gripping elements 46 project into the center of the
hole or other passageway. With respect to the gripping elements,
there can be as few as one or more than two. The gripping elements
can circumscribe the entire opening or they can be discrete
components 46. The gripping elements can be macroscopic as shown in
FIG. 2A or they can be microscopic like sandpaper (not shown). The
gripping elements may have teeth 50 angled toward the top surface
of the anchor. Optionally, two hooks 52, or other graspable
recesses, appendages, or structures, are located on the top surface
of the anterior anchor. Hooks 52 allow for attachment of a surgical
instrument during deployment of the anterior anchor in the patient
as described below. Alternatively, there can be none, one, two or
more than two graspable recesses, appendages, or structures on the
top surface of the anchor. In the preferred embodiment, the
anterior anchor body 42 is disc-shaped, but those of skill in the
art will recognize that other embodiments are possible, as
disclosed in U.S. Patent Application Publication No. 2004/0122456
which is herein incorporated by reference; note particularly the
description of anchor structures. The anterior anchor can also be
wholly comprised of or only partially comprised of one or more
magnetic components. Alternatively, in other embodiments, the
anterior anchor carries one or more weights within it such that
gravity causes the intestinal walls to come together as a result of
the weights within the anchors.
[0084] FIGS. 2C and 2D are cross sections of the anterior anchor of
FIGS. 2A and 2B, taken along the line B-B in FIG. 2B. FIG. 2C shows
the anterior anchor in its deployed configuration with the
connector 12 of FIG. 1A passing through the hole or other
passageway 44 in the body of the anchor. In the deployed
configuration, the gripping elements 46 and teeth 50 engage the
connector 12 with sufficient pressure to prevent movement of the
anchor along the connector 12 in the direction of the arrow in FIG.
2C, which would increase the distance between the anterior anchor
and posterior anchor (not shown). In the case where the connector
is a suture, the surface of the suture can be roughend to enable
gripping by the anchor. In FIG. 2D, the anterior anchor 40 is in
its reduced profile configuration with the connector 12 of FIG. 1A
passing through the hole or other passageway 44 in the body of the
anchor. Preferably, the anterior anchor is made of a semi-rigid
polymer which allows the anchor to be deformed into a substantially
folded configuration illustrated in FIG. 2D. When in this
configuration, the gripping elements 46 and teeth 50 do not
significantly engage the connector 12. This allows movement of the
anterior anchor 40 along the length of the connector 12 in the
directions illustrated by the arrows in FIG. 2D. Once the anterior
anchor is in the desired position along the connector 12, the
anterior anchor is permitted to return to the configuration shown
in FIG. 2C, and the gripping elements 46 and teeth 50 engage the
connector 12, thus preventing movement between the connector 12 and
the anterior anchor 40.
[0085] In an alternative embodiment, it is contemplated that the
connector 12 can have notches 51, which interact with gripping
elements 46 in a ratchet-and-pawl mechanism similar to that used in
cable ties, providing a one-way adjustability, in which the
posterior and anterior anchors can be moved toward each other, but
not away from each other.
[0086] FIGS. 2E and 2F illustrate another embodiment of an anterior
anchor 60 which is similar to the one illustrated in FIGS. 2C and
2D. In FIG. 2E, the gripping elements 62 and teeth 64 are oriented
so that the anterior anchor can be deformed such that the top
surface of the anchor is folded inward as illustrated in FIG. 2F.
This is in contrast to the embodiment illustrated in FIG. 2D where
the bottom surface of the anchor is folded inward. The teeth 64 in
FIG. 2E are angled toward the top surface of the anterior anchor
and engage the connector 12 of FIG. 1A such that they prevent
movement of the anterior anchor along the connector 12 in the
direction of the arrow in FIG. 2E, which would increase the
distance between the anterior anchor and posterior anchor (not
shown).
[0087] FIG. 2G is a perspective view of a preferred embodiment
where the anterior anchor is inflatable. The anterior anchor has a
hollow, inflatable disc-shaped body 65 with a hole or other
passageway 66 substantially in the middle of the body. Two gripping
elements 67 project into the center of the hole or other
passageway, although there can be as few as one or more than two
gripping elements. The gripping elements can have teeth 68 angled
toward the top surface of the anchor. Alternatively, in a preferred
embodiment, the gripping elements are in the form of a rough
surface rather than the protruding elements as shown in FIG. 2G.
Such a surface, which may be a sandpaper-like surface, creates
enough friction to prevent movement in either direction along the
connector. Optionally, two hooks 69 are located on the top surface
of the anterior anchor. Hooks 69 facilitate grasping by a surgical
instrument during deployment of the anterior anchor in the patient
as described below. Alternatively, rather than hooks, there can be
one or more graspable protrusions on the body. In yet another
embodiment, there are no hooks or graspable protrusions, and the
body of the anchor is grasped directly to manipulate the anchor. In
another embodiment, protrusions 69 are magnetic or otherwise sticky
(e.g. Velcro) in nature to facilitate attachment to a surgical
instrument.
[0088] An inflation tube 63 is used to inflate and deflate the
anterior anchor. This inflation tube may or may not have a valve.
In one preferred embodiment, the anterior anchor is filled with gas
or fluid through the inflation tube and the fluid is held inside
the anchor through an external (e.g. stopcock) valve controlled by
the operator. When the inflation tube is cut at the end of the
procedure, the inflation line is crimped closed thereby locking the
inflating substance inside the anchor. Alternatively, the shears
used to cut the inflation line can be metal and an electrocautery
current can be applied through the shears and to the inflation line
to weld it closed.
[0089] FIGS. 2H and 2I are cross sections of the anterior anchor of
FIG. 2G, taken along the line D-D in FIG. 2G. The disc-shaped body
65 is readily deformable when in its reduced profile (i.e.,
uninflated) configuration as shown in FIG. 2I. The body can be
inflated with a substance delivered through the inflation tube 63.
When anchor body is inflated, the anchor assumes its deployed (i.e.
inflated) configuration as shown in FIG. 2H with the connector 12
of FIG. 1A passing through the hole 66 in the body of the anchor.
In the deployed configuration, the gripping elements 67 and teeth
68 engage the connector 12 with sufficient pressure to prevent
movement of the anchor along the connector 12 in the direction of
the arrow in FIG. 2H, which would increase the distance between the
anterior anchor and posterior anchor (not shown). Alternatively,
rather than defined gripping elements and teeth, the surface of
body which defines the sides of the hole or other passageway 66 can
be configured such that when the anchor body is inflated, the sides
of the hole or other passageway expand to substantially close off
the hole or other passageway and limit movement of the anchor
relative to the connector through friction between the connector
and the anchor.
[0090] In FIG. 2I, the anterior anchor 65 is in its reduced profile
(i.e. uninflated) configuration with the connector 12 of FIG. 1A
passing through the hole 66 in the body of the anchor. When in this
configuration, the anchor body is readily deformable and the
gripping elements 67 and teeth 68 do not significantly engage the
connector 12. This allows movement of the anterior anchor 65 along
the length of the connector 12 in the directions illustrated by the
arrows in FIG. 2I. Once the anterior anchor is in the desired
position along the connector 12, the anterior anchor is inflated by
a filling substance delivered through the inflation tube 63, and
the anchor assumes its deployed (i.e. inflated) configuration as
shown in FIG. 2H; the gripping elements 67 and teeth 68 engage the
connector 12, thus restricting movement of the anterior anchor 65
in one or both directions along the length of the connector 12. The
filling substance can be a gas, liquid, or material which changes
phase with time (i.e. it may harden, cure, polymerize, or become a
gel with time).
[0091] FIG. 3A illustrates another embodiment of an anterior anchor
70 consisting of two parts, an anchor body 72 and a readily
deformable collar 74. The anchor body and collar have a central
hole or other passageway (76 and 78 respectively) through which the
connector can pass. Preferably, the anterior anchor body is made of
a semi-rigid polymer which can be deformed into a folded
configuration with a reduced profile as illustrated in FIG. 3B.
Preferably, the readily deformable collar 74 is permanently
deformable; once deformed, it does not return to its original
shape. As illustrated by the arrow in FIG. 3B, both the collar 74
and anchor body 72 can move along the connector 12 of FIG. 1A. Once
the anchor body 72 is in the desired position, the collar 74 is
crushed, such that the collar 74 engages the connector 12 and can
no longer move along the length of the connector 12. This prevents
the anchor body 72 from moving along the length of the connector 12
in the direction of the arrow illustrated in FIG. 3C, which would
increase the distance between the anterior anchor and posterior
anchor (not shown). FIG. 3D illustrates an alternative embodiment
of the anterior anchor 80, where the anchor body 82 and deformable
collar 84 are a single piece.
[0092] In a preferred embodiment, the anterior anchor is made from
a biocompatible, radio- or magneto-opaque polymer, but it can also
be made from various kinds of suitable materials known to those of
skill in the art including metals, metal alloys, plastics, natural
materials or combinations thereof as disclosed above. The anterior
anchor can be solid, or alternatively, can be porous, mesh-like,
umbrella-like or lattice-like. In a preferred embodiment, the
anterior anchor is porous, mesh-like, umbrella-like or lattice-like
to encourage fibrous ingrowth such that it becomes permanently
attached to the stomach wall. Coatings can be added to the anchor,
or a mesh material such as polypropylene can be fixed to the anchor
surface, such that it touches the anterior stomach wall and
encourages tissue ingrowth. In other embodiments, the anterior
anchor is solid and treated to discourage tissue ingrowth with
materials such as silicone, PTFE, or FEP which are generally
hydrophobic and non-reactive. In other embodiments, the anterior
anchor has a xenograft or allograft material attached to the anchor
which ensures tissue ingrowth. In a preferred embodiment, the
anterior anchor is disc-shaped and substantially flat, but those of
skill in the art will recognize that other embodiments are
possible.
Surgical Instruments
[0093] FIG. 4A illustrates one embodiment of a tissue grasping
instrument 200. The tissue grasper has a tubular outer sleeve 210
to which a portion of a handle 212 is attached at the proximal end.
As shown in more detail in the blow-up, FIG. 4A', disposed within
the outer sleeve 210 is a tubular inner member 214 which has an
outer diameter such that it can slide within the outer sleeve 210
in the longitudinal axis of the outer sleeve 210 but cannot move
substantially transverse to the longitudinal axis of the outer
sleeve 210. At the proximal end of the inner member, a second
portion of a handle 216 is attached. At the distal end of the inner
member is a pair of jaws 220 which is connected to the inner member
at a hinge point 222. When the distal end of the inner member 214
is displaced from the inside of the outer sleeve 210 such that the
hinge point 222 is outside the outer sleeve, the jaws 220 assume
their open position as depicted in FIG. 4A. As the hinge point 222
is withdrawn into the outer sleeve 210, the outer sleeve forces the
jaws 220 into their closed position, as illustrated in FIG. 4B. The
opening and closing of the jaws 220 can be accomplished by
manipulation of the handle portions 212 and 216.
[0094] The distal end of the grasping instrument 200 is configured
to cut, puncture, or dilate tissue when the jaws 220 are in the
closed position. In one embodiment shown in FIG. 4B, the jaws 220
have screw-thread-shaped protrusions 224 on the surface. By
rotating the instrument as it passes through tissue, the
protrusions 224 facilitate the penetration of tissue, similar to a
corkscrew. In another embodiment illustrated in FIG. 4C, the
instrument has jaws 226 that form a sharp tip 228 when closed. In
yet another embodiment, the jaws form a blade which can cut through
tissues when in the closed position. One of skill in the art would
recognize that the above configurations can be combined, or that
other configurations are possible which facilitate the passage of
the tip of the instrument through the wall of the stomach or other
tissue.
[0095] It also should be realized to one skilled in the art that
the closed end of the grasping device does not have to be the only
instrument responsible for cutting through the tissue; the central
lumen 230 of the device can be utilized to assist in tissue
penetration. For example, a needle (e.g. a Veres needle) 232 can be
passed through the lumen and the needle 232 can make the initial
puncture through the tissue. The configuration of the distal end of
the grasper is meant to be a tissue dilator and facilitator of the
entry into the stomach after the needle makes the initial puncture.
For safety, the needle can be retracted as the tissue grasper
dilates the tissue.
[0096] In the embodiment of the tissue grasper 200 illustrated in
FIG. 4A, the inner member 214 and outer sleeve 210 have a central
tunnel 230 that extends the length of the tissue grasper. The
tunnel 230 allows for the passage of an expanding means such as a
needle 232, or other instrument or device such as the posterior or
anterior anchor described above (see for example, the description
above regarding the connector-suture combination in which the
suture is left behind and the outer sheath of the connector is
pulled away), through the length of the tissue grasper as shown in
FIG. 4A. The central tunnel is also adapted such that a radially
dilating sheath can be inserted through it. The diameter of the
central lumen is preferably at least 4 mm, but can be at least 5,
6, 7, 8, 9, 10, 11, or 12 mm. In an alternative embodiment, the
distal jaws can be configured to close through an electromechanical
means or purely magnetic means such that the inner member is not
necessary.
[0097] FIG. 5A illustrates one embodiment of an anchor implantation
instrument 250 to implant the anterior anchor. The implantation
instrument has a tubular outer sheath 252 which has a handle 254
attached. At the distal end, the outer sheath Hairs out to an
increased diameter 255 to accommodate the anterior anchor in its
substantially folded position as illustrated in FIG. 5C. Within the
outer sheath is an anchor grasping instrument 256 similar to the
tissue grasping instrument of FIG. 4A, made up of a tubular middle
sleeve 260 and a tubular inner member 264. The tubular middle
sleeve 260 has an outer diameter such that it can slide within the
outer sheath 252 in the longitudinal axis of the outer sheath 252
but cannot move substantially transverse to the longitudinal axis
of the outer sheath 252.
[0098] The tubular middle sleeve 260 of the anchor grasping
instrument has a portion of a handle 262 attached at the proximal
end 261 of the instrument. Disposed within the middle sleeve 260 is
a tubular inner member 264 which has an outer diameter such that it
can slide within the middle sleeve 260 in the direction of the
longitudinal axis of the middle sleeve 260 but cannot move
substantially in transverse to the longitudinal axis of the middle
sleeve 260. At the proximal end of the inner member, a second
portion of a handle 266 is attached.
[0099] The distal tip 263 of the instrument is illustrated in more
detail in FIGS. 5B and 5C, with the inclusion of the anterior
anchor 40 of FIG. 2A and connector 12 of FIG. 1A. FIG. 5C is a side
section view taken along the line C-C of FIG. 5B. At the distal end
263 of the inner member 264 is a pair of hooking members 270 which
are connected to the inner member at a hinge point 272. When the
distal end of the inner member 264 is displaced from the inside of
the middle sleeve 260 such that the hinge point 272 is outside the
middle sleeve, the hooking members 270 assume their open position
as depicted in FIG. 5B. As the hinge point 272 is withdrawn into
the middle sleeve 260, the middle sleeve forces the hooking members
270 into a closed position, as illustrated in FIG. 5C. The opening
and closing of the hooking members 270 can be accomplished by
manipulation of the handle portions 262 and 266.
[0100] The instrument is designed such that the anterior anchor is
easily manipulated. When the anterior anchor is in its
substantially folded or compressed configuration as in FIG. 5C, the
entire anterior anchor assembly can be manipulated along the
longitudinal axis of the connector 12. FIG. 5C depicts the assembly
as it would be introduced over the connector 12 and into the
patient. The operator pulls the connector 12 toward the operator
such that the posterior anchor is urged toward the anterior anchor.
When in position, the operator deploys anterior anchor 40. To
deploy anterior anchor 40, outer sheath 252 is pulled back toward
the operator. Middle sleeve 260 is then withdrawn proximally toward
the operator as well. Hooking members 270 tend to fan out as the
middle sleeve is pulled back and will release hooks 52. Once
deployed, anterior anchor 40 is now fixed in a longitudinal
position along the connector 12.
[0101] If the surgeon wants to readjust the anterior anchor,
connector 12 is manipulated so that the hooks 52 of the anterior
anchor are brought into contact with hooking members 270; middle
sleeve 260 is advanced distally from the operator, permitting
hooking members 270 to engage the hooks 52; such contact is
facilitated by pulling back (proximally) on the connector 12. By
manipulating the middle sleeve 260 over the hooking members 270,
the hooks 274 on the ends of the hooking members 270 can engage the
hooks 52 on the anterior anchor 40. The outer sheath 252 is then
slid over the anterior anchor 40 (or the anchor-middle sleeve
complex is withdrawn into the outer sheath 252), until it is
compressed into an undeployed configuration as shown in FIG. 5C. As
described above, when the anterior anchor 40 is in a substantially
compressed configuration, it can move along the length of the
connector 12 in either direction.
[0102] In an embodiment where an inflatable anterior anchor such as
the one illustrated in FIGS. 2G-2I is utilized (or in the case that
the anterior anchor is otherwise sufficiently compliant to be
pushed through a laparoscopic port), a standard laparoscopic
grasping instrument (with teeth) can be used to manipulate the
anterior anchor. When the inflatable anterior anchor is in the
uninflated position, it is sufficiently compliant such that it can
easily be passed through a laparoscopic port prior to inflation and
deployment or after it has been deflated for readjustment; the
middle sheath may not be necessary because the compliance of the
balloon enables easy compression into the outer sheath. The
inflation tube 63 passes through the laparoscopic port and out of
the patient. This allows the inflation tube 63 of the anchor to be
temporarily opened or closed outside the patient allowing for
deflation and reinflation until the anchor is in place. The
inflation tube is then sealed and cut oft preferably substantially
flush to the surface of the anterior anchor.
Implantation of the Transgastric Fastening Assembly
[0103] FIG. 6A depicts the initial step of a preferred embodiment
of a surgical method to implant the transgastric fastening
assembly. The first part of the procedure, the "percutaneous
procedure" involves entering the stomach with an endoscope 300 and
insufflating the stomach with a gas. When insufflated, the anterior
wall of the stomach 302 is pushed toward the anterior abdominal
wall 304 to create a potential space (the stomach). After
insufflation of the stomach, an incision is made in the skin and a
standard laparoscopic port 306 is placed through the anterior
abdominal wall 304 to a position wherein the distal end is in the
potential space between the abdominal wall 304 and the anterior
wall of stomach 302. The laparoscopic port 306 can be a radially
dilating type port or similar port known in the art.
[0104] A particularly advantageous port is one which allows
visualization (with a laparoscope) of the individual abdominal
layers as it is being pushed through the abdominal wall (well known
to those skilled in the art). Use of such a port allows the surgeon
to "see" the different layers of the abdominal wall from within the
trocar (using a standard laparoscopic camera) as the trocar is
advanced through the abdominal wall. The endoscopic light inside
the stomach will be "seen" by the surgeon as the port approaches
the inner layers of the abdominal wall because the endoscopic light
source transilluminates through the layers of the stomach wall and
inner layers of the abdominal wall. Such visualization is
advantageous if the patient has a very thick abdominal wall (e.g.
in a morbidly obese patient) because the surgeon needs to ensure
that another organ (e.g. the colon) is not positioned between the
stomach and the posterior wall of the abdomen. Once the
transillumination of the stomach is visible through the transparent
port, the port 306 can be slipped in the abdomen between the
abdominal wall and the anterior wall of the stomach. This portion
of the procedure can be done without pneumoperitoneum and without
general anesthesia. At this point, a camera can be placed inside
the laparoscopic port to visualize the anterior wall of the
stomach. Visualization of the surface of the stomach can also be
achieved with this method and does not require general
pneumoperitoneum. The camera can be slid along the stomach to reach
virtually any portion of the anterior stomach or duodenal wall.
Additional ports can also be placed in the space between the
abdominal wall and the anterior wall of the stomach. At this point
in the procedure, a therapeutic energy device can be applied to the
stomach. For example, a laser, a radiofrequency device, a microwave
device, or an ultrasound device can be applied to the stomach.
Furthermore, electrical or nervous mapping can be performed with
the surgical device in the position between the anterior wall of
the stomach and the abdominal wall. In the embodiment where an
extragastric balloon is being deployed (see below), such deployment
proceeds at this step. Furthermore, in the embodiment where
balloons are placed inside the stomach or neuro- or muscular
stimulators or other devices are placed, they are implanted at this
step and do note require general anesthesia and do not require
general anesthesia.
[0105] In an alternative embodiment, "the laparoscopic procedure,"
a pneumoperitoneum is created through a separate incision in the
skin. A veres needle, or other standard method to create a
pneumoperitoneum (as is well-known to surgical practitioners) is
used to insufflate the abdominal cavity.
[0106] In the percutaneous procedure, the tissue grasping
instrument 200 of FIG. 4A is inserted through the port 306 with the
jaws 220 in the closed position (with or without a needle
projecting in front of the instrument) and is passed through the
anterior wall of the stomach 302. When the jaws of the instrument
are closed, the jaws define a sharp, dilating, and/or cutting
configuration which can more easily advance through the stomach
wall.
[0107] FIG. 6B depicts the next step in the percutaneous procedure.
The jaws of instrument 200 are used to grasp the posterior wall of
the stomach 314. The posterior wall of the stomach 314 is lifted
away from the retroperitoneum 316, allowing for access to the
potential space of the lesser peritoneal sac 320. A needle 232,
such as a Veres needle (well-known in the art, a Veres needle
allows for easy and safe access into and between two serosal
layers), is inserted through the central channel 230 of the
instrument and passed through the posterior wall of the stomach 314
into the potential space of the lesser peritoneal sac 320. The
potential space of the lesser peritoneal sac 320 is expanded by
injection of a gas, such as carbon dioxide, through the needle 232.
In other embodiments, the potential space is expanded using a
liquid, gel, or foam. Alternatively, the space can be expanded
using a balloon or other space expanding or space filling device;
alternatively, a surgical instrument (e.g. electrocautery and/or
blunt ended grasper, etc.) can be used in place of a needle to
access the lesser peritoneum or to expand the potential space of
the retroperitoneum 320. Preferably, the expanded space of the
lesser peritoneal sac can extend from the angle of His at the
gastroesophageal junction to the pylorus.
[0108] In an alternative embodiment, the space is not expanded
before the posterior anchor is placed. For example, in an
embodiment where an inflatable posterior anchor is used, the
potential space can be expanded by the anchor itself as it is
inflated to its deployed configuration.
[0109] FIG. 6C depicts the next step in the "percutaneous
procedure" embodiment. With a direct path from outside the patient
to the lesser peritoneal sac 322, the needle 232 is withdrawn from
the instrument 200. An optional dilation step can be performed at
this stage in the procedure using a device such as a radially
dilating sheath (e.g. InnerDyne STEP.TM. system; Sunnyvale, Calif.)
inserted through the central channel 230 of the instrument. The
dilating device expands the opening in the posterior wall of the
stomach in such a way that the opening contracts down to a lesser
profile after dilation. A posterior anchor 324 and connector 326,
such as those depicted in FIGS. 1B, 1E or preferably 1F, in its
reduced profile configuration, is passed through the central
channel. 230 of the instrument, through the posterior wall of the
stomach 314, and deployed in the lesser peritoneal sac 322 as shown
in FIG. 6C. Where the optional dilation step is performed, the
posterior anchor 324 is passed through the dilating sheath. The
connector 326 is preferably of sufficient length to pass from
inside the lesser peritoneal sac 322 through the central channel
230 of the instrument and out of the patient's body. FIG. 6D
depicts the deployed posterior anchor 324 and connector 326 after
the grasping instrument is withdrawn from the patient and tension
is applied to connector 326 to pull the posterior anchor 324
against the posterior wall of the stomach 314.
[0110] In the "laparoscopic embodiment," after insufflation of the
abdominal cavity with a Veres needle, a retrogastric tunnel is
created as is well known in the surgical art and is shown in FIG.
15a. The posterior anchors 510 are shown as a component of the
retrogastric instrument in FIGS. 12 and 15a. The posterior anchors
308 are also shown in FIG. 6E. The suture-connector system 309, 311
depicted in FIG. 1H-J is also depicted in FIG. 6E and is used in
one of the laparoscopic embodiments. Connector 309 engages anchor
308 and locks suture 311 into posterior anchor 308. Connector 309
is then slid over suture 311 prior to the anterior anchor (FIG. 13;
550) being slid over (tracking) the connector 311.
[0111] FIG. 12 depicts one step in one laparoscopic embodiment; a
laparoscopic instrument 500 is provided which has a reversibly
attached anchor 510. Grips 520 reversibly grip anchor 510. Any of a
variety of gripping mechanisms can be employed to retain the anchor
510 on laparosopic tool 500. Connector 332 is substantially similar
to any of the connectors described above except that the posterior
anchor 510 is not attached to connector 332 when it is inserted
through the anterior abdominal wall. The surgeon places
laparoscopic tool 500 behind the stomach 428 of the patient and
connector 332 is advanced through lumen 545 formed in patient's
skin 535 and anterior abdominal wall 530. Connector 332 is then
further advanced percutaneously through first and second walls 540
and 547 of stomach 428.
[0112] When the connector 332 reaches the posterior anchor 510,
gripping elements 520 are released by the surgeon through a
mechanism which is integrated into the laparoscopic tool 500.
Connector 332 is fixed to posterior anchor 510 through a locking
mechanism. Mechanisms of locking connector 332 to posterior anchor
510 are well-known to those skilled in the art of mechanical
fixturing. Some or all of the fixturing mechanisms may reside on
the connector or on the anchor. In another embodiment, the gripping
force of the grippers 520 can be overcome by force applied by the
surgeon on connector 332. Mechanisms of locking other than
mechanical also exist and include magnetic, electromagnetic, and
adhesive means.
[0113] An anterior anchor 550 (FIG. 13) is then placed over the
connector 332 by the methodology and devices described in the next
paragraph; the mechanism of deploying the anterior anchor is the
same in both the "laparoscopic" and "percutaneous" procedures, The
walls of the stomach are urged together (FIG. 14) to create a
resistance to the flow of food within the stomach. 570 depicts one
side of the stomach after the walls of the stomach are urged
together. 570 is the side of the stomach where food enters. Its
volume and capacity are now reduced as compared to its original
volume and capacity. Although not shown, connector 332 is
subsequently truncated at the level of the anterior anchor 550
after the anterior anchor is deployed and by any of the mechanisms
described and depicted above.
[0114] FIG. 7A illustrates the step of implanting the anterior
anchor. The connector 326 is inserted through the hole or other
passageway of an anterior anchor 40 of FIG. 5C, and the anchor
implantation instrument 250 of FIGS. 5A, 5B and 5C is used to slide
the anchor 40 through the laparoscopic port 306 into the abdomen of
the patient. The anterior 302 and posterior 314 walls of the
stomach are urged together, either by using the anchor implantation
instrument 250 to urge the anterior wall 302 toward the posterior
wall 314, or by pulling on the connector 326 and posterior anchor
324 to urge the posterior wall 302 of the stomach toward the
anterior wall 314, or by a combination of the two methods. Once the
anterior anchor 40 is in the desired position, the anterior anchor
40 is placed in its deployed configuration by manipulating the
anchor implantation instrument 250 as described above.
[0115] In a preferred embodiment, the inflatable anterior anchor of
FIGS. 2G-2I is used, and the use of the implantation instrument of
FIG. 5C is optional. After the anterior anchor is in the desired
position, the anterior anchor is inflated with a filling substance
through the inflation tube until it is in its deployed
configuration. The gripping elements 67 and teeth 68 are thus
engaged against the connector 326. The anchor implantation device
250 can then be withdrawn from the patient's abdomen.
[0116] With the transgastric fastening assembly complete, the
surgeon can examine the resulting configuration of the stomach
using an endoscope. If the anterior anchor is not in the desired
location, its placement along the connector can be adjusted as
described above. Alternatively, in another embodiment, the anterior
anchor can be urged closer to the posterior anchor simply by
pushing it along the connector without using the implantation
device to capture the anchor and deform it into its reduced profile
configuration.
[0117] In another embodiment, the anterior anchor can be deflated,
allowing the anterior anchor to be repositioned, and then
reinflated to engage the connector. FIG. 7B illustrates the
transgastric fastening assembly with the anterior anchor 40 in its
deployed configuration on the connector 326 and the anchor
implantation instrument removed from the patient's abdomen. The
anterior 302 and posterior walls 314 of the stomach have been urged
closer together by the transgastric fastening assembly. Whether the
walls of the stomach are urged into contact or not is determined by
the surgeon. Contact between the mucosal surfaces can be loose such
that food can go through yet a significant resistance is provide;
alternatively, mucosa! surfaces are urged together to touch but
food cannot pass through the apposition.
[0118] FIG. 7C depicts a transgastric fastening assembly in its
final configuration after deployment. Once the surgeon is satisfied
that the transgastric fastening assembly is properly placed, a
cutting implement, well-known to those of skill in the art, is
inserted through the laparoscopic port and the connector 326 is
cut, preferably flush to the anterior anchor 40. In some
embodiments, the cutting instrument is placed over the connector
(tracks) with the connector as a guide. In an embodiment, where
inflatable anchors are used, the hollow connector and inflation
tube are sealed prior to, or as a result of, cutting, preventing
anchor deflation. Alternatively, if a filling substance which
hardens with time is used, it may not be necessary to seal the
connector or inflation tube prior to cutting if the filling
substance is sufficiently hard or viscous such that it will not
leak from the connector or inflation tube.
[0119] When more than one transgastric fastening assembly is to be
implanted, it is sometimes preferred to insert all of the posterior
anchors and connectors before attaching any or all anterior
anchors; in some embodiments, an instrument to measure tension is
used to measure the compression of the stomach mucosa prior to the
operation. This is in contrast to attempting to place one complete
transgastric fastening assembly and then subsequent assemblies.
While possible, if one were to place entire fastening assemblies in
series, each successive assembly would be more difficult to place
because the volume of the stomach would be progressively reduced
resulting in more difficult visualization each time.
[0120] FIG. 8A depicts an embodiment in which two posterior anchors
330 and connectors 332 are deployed in the expanded lesser
peritoneal sac. In this embodiment, there is one laparoscopic port
334 for each connector 332. Alternatively, there may be more
anchors placed than incisions and laparoscopic ports. Depending on
how far apart the anchors are placed, a given laparoscopic port can
be used to implant a plurality of transgastric implants. This can
be accomplished because there is significant mobility of the
stomach and/or abdominal wall which allows for different points
along the anterior wall of the stomach to be accessed without
having to create another hole through the abdominal wall.
[0121] When it is desired to place more than one set of
transgastric assemblies and in particular when the assemblies arc
placed concurrently rather than sequentially, the surgeon is
afforded the opportunity to test (e.g. measuring stomach volume,
resistance to flow, assessing mucosal integrity, etc.) varying
tensions on one or more of the fastening assemblies, all under
endoscopic inspection. After the desired number of posterior
anchors and connectors are deployed in the patient, the
configuration of the stomach can be tested by applying tension to
the connectors. FIG. 8B depicts temporary clamps 336 which sit on
top of the ports 334. In some embodiments, the clamps are
tensiometers which quantify the tension between the anchors.
Connectors 332 can be pulled from outside the abdomen to urge the
posterior wall of the stomach 340 toward the anterior abdominal
wall 342. One or more clamps 336 can then be closed to hold the
stomach in a test position. To determine if the posterior anchors
330 are in the desired location, an endoscope 344 can be used to
view the configuration and the tension that the stomach will endure
after the anterior anchors are placed.
[0122] In an alternative embodiment, the stomach is fastened to the
abdominal wall rather than there being a free space between the
anterior gastric wall and the peritoneum of the abdominal wall (not
shown). The initial steps are as discussed above. After the
posterior anchors are placed, their position can be tested as
depicted in FIG. 8B to simulate the configuration after the
anterior anchor is placed. Next, the outer laparoscopic port is
pulled back so that the anchor deploying instrument directly
contacts and sits within the tissues of the muscular abdominal
wall. Once the outer laparoscopic port is pulled back, the anterior
anchor can be deployed within the abdominal wall musculature and
the connector can be cut flush with the anterior anchor. In an
embodiment where the inflatable anterior anchor is used, after the
anterior anchor is deployed within the abdominal wall musculature,
the inflation tube is cut, preferably flush with the anterior
anchor.
Reversal of the Gastric Volume Reduction Procedure
[0123] The connector of a preferred embodiment of the deployed
transgastric fastening assembly, as illustrated in FIG. 7C, can be
cut at a point between, the anterior and posterior anchors, which
results in reversal of the gastric volume reduction. The connector
is preferably made to resist corrosion from stomach acid, but is
able to be cut by a cutting implement advanced through an endoscope
into the stomach. In the Smith paper (full reference above), a
nylon suture was used to traverse the stomach in the
anterior-posterior direction and attach the pledgets to the walls
of the stomach. The nylon material was suitable for use for over 3
years without any indication of corrosion (Smith, L. et. al.
Results and Complications of Gastric Partitioning. The American
Journal of Surgery. Vol. 146; December 1983). Other materials
suitable to prevent corrosion and yet allow cutting include
plastics such as polyurethane, silicone elastomer, polypropylene,
PTFE, PVDF, or polyester, metals and metal alloys such as stainless
steel, nickel-titanium, titanium, cobalt-chromium, etc. Once the
connector is cut, the walls of the stomach are free to move away
from one another, thereby reversing the procedure. Reversal of the
procedure can occur at any time (days to years) after the
procedure. In a preferred embodiment, the anchors remain in the
gastric wall permanently even after the connector is cut or
otherwise divided. Alternatively, the anchors can in part or in
whole be manufactured from a bioabsorbable material such that the
anchors will eventually be absorbed by the body. In the case of
bioabsorbable anchors, it is preferable to have a connector which
is at least in part bioabsorbable. In another embodiment,
substantially all of the elements of the transgastric fastening
assembly are made of bioabsorbable materials, with the intent that
over the desired period of time, the entire assembly will be
absorbed by the body, reversing the procedure without any
additional actions required by a doctor. In another embodiment, the
anchors are made of a non-reactive material such as silicone. In
this embodiment, reversal of the procedure requires a "laparoscopic
procedure;" that is, pneumoperitoneum. The connector is cut with
the endoscope and then the anchors are removed with standard
laparoscopic instrumentation; being composed of silicone, the
anchors in this case will be easily removed.
[0124] Even if there is some degree of fusion between the mucosa
around the connector at the region of the assembly, once the
connector is cut or absorbed, the walls will tend to move apart
over time. Alternatively, a balloon or other dissection device is
introduced through an endoscope and used to separate the walls of
the stomach at the point of fusion.
Treatment of Disease Conditions
[0125] The devices, methods and instruments disclosed above can be
used to treat obesity and other diseases involving the
gastrointestinal tract, such as gastroesophageal reflux disease
(GERD). FIG. 9 depicts three transgastric fastening assemblies 400
deployed longitudinally in the stomach; such a configuration of
anchors results in a tubular configuration of the remaining portion
of the stomach The dashed lines represent boundaries of the
divisions of the stomach: the cardia of the stomach 402, the fundus
of the stomach 404, the body of the stomach 406, the antrum of the
stomach 408, and the pyloric sphincter 410. In a preferred
embodiment, the fastening assemblies are not implanted in the
antrum 408 in order to maintain the normal digestion process of the
stomach. Normal digestion occurs in the antrum which precedes
passage of food into the duodenum. In stopping short of the antrum
408, the implants replicate the degree of volume reduction of the
Magenstrasse and Mill (M&M) procedure (discussed above).
[0126] Food ingested by the patient follows a physiologic pathway
for digestion depicted by the arrow in FIG. 9. It travels through
the esophagus 412 and enters the cardia of the stomach 402. The
food is digested in the stomach and pushed toward the duodenum 414
as chyme for further digestion. The preserved antrum 408 allows for
relatively physiologic digestion and emptying into the duodenum 414
akin to the M&M procedure. With transgastric fastening
assemblies 400 in place, food which leaves the esophagus 412 and
enters the stomach, results in increased wall tension on the lesser
curvature of the stomach 416 as the greater curvature of the
stomach 418 will be restricted from the food pathway. The path of
least resistance will be the path toward the pylorus 410 and
duodenum 414. The increased wall tension of the stomach will result
in a feeling of satiety by the patient, leading to decreased food
intake and weight loss. Although three assemblies are shown in FIG.
9, there may be as few as one or as many as ten depending on the
degree of volume reduction desired. Such flexibility in number of
devices as well as the ability of the surgeon to tune the tension
between the anterior and posterior anchors is advantageous. Such
flexibility may enable, for example, reversal of a few anchors
rather than all the anchors, such that the volume reduction
procedure is partially reversed.
[0127] In another embodiment, a transgastric fastening assembly is
placed in the antrum 408 or the region just proximal to the pyloric
sphincter 410 if deemed necessary by the gastroenterologist and/or
surgeon. Such a configuration would not reduce the volume of the
stomach but would cause a feeling of fullness similar to a gastric
outlet obstruction, leading to decreased food intake and weight
loss. The anchors in this region can also conduct a current to
electrically stimulate the stomach to simulate satiety.
[0128] In another embodiment, a transgastric fastening assembly may
be required at the region of the cardia 402 to treat morbid obesity
in a similar manner to that utilized with the LAP-BAND.TM. (Inamed
Corp., Santa Barbara, Calif.). In this embodiment, the transgastric
fastening assembly is not utilized to reduce the volume of the
stomach, but to create a restriction to the inflow of food. In this
embodiment, the fastening system can traverse the cardia but will
not completely oppose (or at least will not prevent the flow of
food through the fastening system) the mucosal surfaces of the
anterior and posterior walls of the stomach.
[0129] In another embodiment, the surgeon or gastroenterologist may
choose to treat a disease such as gastroesophageal reflux disease
(GERD) with a transgastric fastening assembly in the cardia region.
Such a configuration would maintain the position of the GE junction
in the abdomen and potentially create a barrier to reflux
contents.
[0130] In another embodiment, the disclosed method in combination
with the transgastric fastening assemblies can be adapted to attach
a gastrointestinal organ to the abdominal wall which in addition to
reducing volume can also create a kink in the organ. The kink would
cause a resistance barrier (in addition to volume reduction) to
gastrointestinal contents, and can be useful to treat reflux
disease or morbid obesity.
[0131] Such a kink would also fix the gastrointestinal region to
the abdominal wall can also maintain the reduction of a hiatal
hernia in the abdominal compartment (e.g. in reflux disease). A
major component of reflux disease is a hiatal hernia in which the
gastroesophageal junction freely slides from the abdomen to the
mediastinum. A percutaneously placed suture or anchor in the region
of the gastric cardia and/or fundus can tether the junction to the
abdominal wall and confine the junction to the abdomen.
[0132] In other embodiments, the devices and methods of this
invention can assist in the implantation of devices such as stents,
meshes, stitches, or tubes in the gastrointestinal tract. The major
technical difficulty encountered in placing stents, tubes,
balloons, stimulators, and meshes inside the lumen of the
gastrointestinal tract is that they tend to migrate because the
walls of such devices do not adhere to slippery mucosa. A
transgastric or transintestinal anchor, implanted with the current
instrumentation could solve this problem. Such a method would be
particularly useful in the attachment of the stein part of the
stent-sleeve system outlined in patent application WO 04049982 , or
the mesh of patent application W003086247A1. In another example,
devices such as those disclosed in patent U.S. Pat. No. 6,773,441
attempt to place an endoscopic stitch to tether the cardia of the
stomach to the fundus to treat reflux disease. Such stitches are
tenuous in the long term because they do not necessarily penetrate
the serosa. Even if the stitches penetrate the serosa, they tend to
erode through the wall with time because of their thin profile and
an inability of the endoscopic operator to control tension on the
suture when it is placed. With the methods and devices of this
invention, such an endoscopic suture can be buttressed with a
percutaneously placed anchor.
Other Embodiments of the Disclosed Devices, Instruments, and
Methods
[0133] Although the described methods are focused on the
implantation of transgastric fastening assemblies to reduce the
volume of the stomach or to increase the resistance to the flow of
food in the stomach, the methods and devices can easily be expanded
to the placement of other types of devices such as
neurostimulators, gastric muscle stimulators, gastric balloons, and
bulking devices inside the wall of a gastrointestinal organ using
the percutaneous methods and devices described herein.
[0134] The methods can further be used to apply an energy source to
an internal organ. For example, the methods and devices of the
current invention can be used to apply radiofrequency probes,
microwave probes, ultrasound probes, and radioactive probes in
similar ways as disclosed in PCT WO 00/69376. The methods can
further be used for diagnostic purposes prior to performing a
surgical therapy. In one example, the methods and devices are used
to identify specific nerves or nerve plexuses prior to a delivering
a specific therapy. In another example, specific hormone producing,
such as ghrelin are identified prior to delivering a specific
therapy.
[0135] In one embodiment of the current invention, a
neurostimulator or neurostimulator lead is placed in the serosal
layer of the stomach or small intestine to stimulate the muscular
or nervous portion of the stomach or small intestine (e.g. the
duodenum). In some embodiments, the stimulator contacts and acts on
the parasympathetic, the enteric, or the sympathetic nervous
system; in other embodiments, the stimulator acts on the muscular
portion of the stomach. The stimulator can be placed anywhere along
the stomach including the anterior and/or posterior walls of the
stomach. In some embodiments, the stimulator contacts the mucosa
and in other embodiments, the stimulator does not contact the
mucosa. In some embodiments, a sensor is placed as a component of
the stimulator or as a separate device. In some embodiments, the
stimulator further communicates with a second or third
stimulator.
[0136] In one embodiment, a sensor is implanted using the methods
and devices described herein; the sensor can communicate with the
stimulator. In one example, the sensor is placed in the stomach
wall and senses stretch in the stomach. This sensor communicates
with the stimulator device to create a feedback loop in which
stretch is sensed (the sensor) and then a signal is sent to the
stimulator portion of the system (the device efferent pathway)
wherein a nerve (the patient afferent pathway), for example, the
vagus nerve or sympathetic plexus is stimulated to prompt the
patient to slow their food intake. The effecter of the feedback
loop does not have to be a nervous structure and in some
embodiments is a muscular portion of the stomach or duodenum such
as the pyloric channel, the antrum, the cardia, or the fundus. In
some embodiments, the effecter is a stimulus such a.sub.ds a small
electrical current under the skin to inform the patient that the
stomach is full and to stop eating. The current or effecter portion
of the feedback loop can increase in intensity if the patient
ignores the signal and continues to push food into the stomach
cavity.
[0137] In some embodiments, the methods and devices described
herein to place devices inside or outside the stomach; inside or
outside the lesser sac of the peritoneum; inside or beside a
structure within the retroperitoneum; inside, beside, or outside
the duodenum, pylorus, or gastroesophageal junction. Implanted
devices include but are not limited to the anchor devices and
transgastric fastening assemblies described above, gents, meshes,
stent-grafts, stitches, and bulk forming agents can be placed as
well.
[0138] In one embodiment, a transgastric fastening assembly serves
to reduce the volume of the stomach as well as provide for
electrical stimulation, In this embodiment, an electrical signal
runs through electrodes in the transgastric fastener assembly to
alter the contraction patterns of the stomach or to electrically
create a feeling of satiety in addition to reducing the volume of
the stomach and creating a restriction to flow in the stomach.
Thus, fastener assemblies of the present invention can serve as
electrodes which are useful, for example, for gastric electrical
stimulation.
[0139] In one embodiment, a satiety pathway is recreated surgically
by implanting a transgastric fastening assembly wherein the
connector is adapted to be a strain gauge and the fastening
assembly is further connected via a device efferent pathway to a
patient afferent pathway. Examples of patient afferent pathways
include the parasympathetic or sympathetic nervous system which
contain patient afferent fibers.
[0140] In another embodiment, a satiety pathway is recreated
surgically by placing a constricting balloon around a portion of
the stomach where the constricting balloon is able to sense
circumferential tension such as, for example, would be created when
food flows through the distal esophagus and proximal stomach.
Surgical constricting balloons which circumscribe the
gastroesophageal junction are well-known in the art (see for
example, U.S. Pat. No. 64,653,213.); the surgical constricting
balloons can be retrofitted with sensors in order to create device
afferent pathways which detect overeating and simulate patient
afferent pathways such as the vagus nerve or the visceral nervous
system.
[0141] The methods and devices of this invention can also be used
to place sutures in the stomach or pylorus to treat reflux disease
or obesity. Such suturing would be facilitated by the placement of
multiple ports through the walls of the stomach. Any of these
methods and devices could be used in combination with or in place
of the transgastric fastening assemblies to induce weight loss in a
patient.
[0142] In another embodiment, the novel methods, implantation
devices, and anchors of this invention are used to implant devices
in one wall of a gastrointestinal organ without volume reduction.
One example of such an embodiment is illustrated in FIGS. 10A and
10B in which a balloon-like device is deployed in the stomach to
displace volume rather than to reduce volume from the outside. The
internal balloon 430 is similar to the posterior anchors in some of
the embodiments described above. In one embodiment, after initial
insufflation of the stomach and placement of a laparoscopic port
306 (percutaneously and without pneumoperitoneum) between the
abdominal wall 304 and the anterior wall of the stomach 302, an
instrument is used to penetrate only the anterior wall of the
stomach 302 and place an inflatable intragastric balloon 430.
Inflation is achieved through the connector lumen 432 and the
balloon is placed within the interior of the stomach 428, as
illustrated in FIG. 10A. When inflated, the balloon 430 is
preferably spherical in shape such that it occupies a substantial
portion of the stomach volume when inflated. In the embodiment
shown, the connector also acts as the inflation tube for inflating
the intragastric balloon. In another embodiment, in addition to the
connector, there is a separate inflation tube similar to
embodiments presented above. As discussed above, a valve can be
located between the anchor and the connector, or alternatively
outside the patient. Preferably after the intragastric balloon is
inflated and an anterior anchor 434 is deployed on the connector
432, as described previously. The connector is also cut, preferably
flush with the anterior anchor, and the laparoscopic port is
removed, as shown in FIG. 10B. The anchor portion of the
intragastric balloon is then fixed in the wall of the stomach. In
the preferred embodiment where an inflatable anterior anchor 434 is
used, the inflation tube is also cut, preferably flush with the
anterior anchor. Other devices which may only be implanted in one
gastric wall include neurostimulators, muscular stimulators,
sensors, and pharmaceutical delivery devices.
[0143] In another embodiment, an extragastric balloon is used to
reduce the volume of the stomach and/or create a barrier to the
flow of food and a restrictor to the flow of food., FIG. 11a
depicts the balloon 430 in the undeployed configuration. The
balloon is placed through a trocar port 306 which is placed in
between the peritoneum and anterior wall of the stomach as
described in detail above. FIG. 11B shows an embodiment of an
extragastric balloon 430 in its deployed state. The balloon 430 is
attached to the abdominal wall by any of the percutaneous
anchor-connector assemblies and methods described above. Stem 432
is the residual from the connector used to place the balloon with
an optional access port for further inflation and/or deflation
after the balloon is placed. In some embodiments (FIG. 11c), the
posterior portion of the balloon 436 is fixed to the outer portion
or inner portion of the stomach using any of the fastening systems
described above, The posterior portion of the balloon can also be
fixed to the anterior gastric wall with an anchor delivered through
the stomach with an endoscope. The extragastric balloon can be
placed anywhere along the stomach, even at a position 1-5 cm below
the gastroesophageal junction at the same place where
laparoscopically placed adjustable gastric bands are currently
placed. The balloon can further be shaped to circumscribe, or form
a lumen around, a structure such as the gastroesophageal junction.
As described above, any of the balloon embodiments can further
contain an integral sensor to detect changes in volume of the
restricted portion of the stomach. Such changes in volume can then
be used to create satiety feedback loops to deter the patient from
further food intake.
[0144] FIG. 18 embodies another use for the current invention. The
sleeve device 620 is disclosed in US patent application publication
US2004/02206882. A major difficulty with this sleeve device is that
it is not easily fixtured for stability inside the stomach.
Fastening system 610 is used to assist in fixation of the device
620 to the stomach wall; fastening system 610 is any of the devices
discussed above and is implanted by any of the methods discussed
above.
[0145] In another embodiment, a surgical anastomosis is surrounded
with the organ spanning anchors and anchor assemblies of the
current invention. In this embodiment, the anchors can buttress the
anastomosis to protect the integrity of the anastomosis. The
buttresses support both the hand-sewn and the stapler anastomotic
techniques. To prevent or support leaks, the anchors are placed
around or through the anastomosis.
[0146] The anchors can also be used to control the flow of material
through the anastomosis. Flow control is attainable when two
anchors are applied across an anastomosis and are linked by means
of a connector through the anastomosis. The distance between the
anchors determines the amount of flow through the anastomosis and
therefore, the flow rate can be adjusted quite readily with the
device of the current invention. The flow rate is adjustable at
anytime during or after the operation. Luminal devices to control
the flow rate through an anastomosis can be found in patent
application number 20050022827. The devices of the current
invention can be used to accomplish the goal of controlling flow
through an anastomosis by placing anchors on either side of the
anastomosis with a connector that traverses the anastomosis.
[0147] In other embodiments, the anchors of the current invention
can be used to secure luminal devices such as stents (e.g. see
patent application number 20050022827.)
[0148] In another embodiment, the anchor assemblies are applied to
the lung to treat chronic obstructive pulmonary disease (COPD) via
functional lung reduction. Rather than removing a portion of the
lung (the surgical procedure), the anchors of the current invention
are placed through the diseased portion of the lung to close off or
at least create a large resistance in one portion of the lung and
broncheoalveolar tree so that inspired air does not reach a
malfunctioning portion of the lung.
[0149] Similarly, the anchor assemblies and anchors are applied to
other solid organs such as the spleen, kidney, liver, and pancreas
to urge the edges of a defect together to promote healing.
[0150] In other embodiments of the current invention, the fastening
systems and tools to implant the fastening systems are used to
secure closure or repair of blood vessels. The blood vessels can be
named vessels such as the aorta, vena cava, pulmonary veins,
pulmonary arteries, renal vein, renal artery, inferior mesenteric
vein and/or artery, splenic vein and/or artery, portal vein and/or
hepatic artery, or the saphenous and/or deep veins. Alternatively,
the vessels are unnamed such as in the case of the mesentery of the
colon or small bowel. Vessel closure with the current system is
possibly more efficient than current laparoscopic means of vessel
closure which involve staple or clip occlusion of the vessels;
staples and clips do not penetrate the vessel and therefore are
often inadequate, or at least do not replicate what a surgeon would
do in an open procedure which is place a suture through the vessel
to "suture ligate" it as is well-known in the art.
[0151] It is also possible that a part of, or any or all of the
devices and methods described above are performed with an
alternative imaging means; for example, fluoroscope, MRI, CAT
scan.
[0152] Although the present invention has been described in the
context of certain preferred or illustrative embodiments, it should
be understood that the scope of the exclusive right granted by this
patent is not limited to those embodiments, but instead is the full
lawful scope of the appended claims.
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