U.S. patent application number 11/001687 was filed with the patent office on 2005-07-14 for transoral endoscopic gastroesophageal flap valve restoration device, assembly, system and method.
This patent application is currently assigned to EsophyX, Inc.. Invention is credited to Adams, John M., Kraemer, Stefan J.M., Vincent, Stephen T..
Application Number | 20050154405 11/001687 |
Document ID | / |
Family ID | 29419321 |
Filed Date | 2005-07-14 |
United States Patent
Application |
20050154405 |
Kind Code |
A1 |
Kraemer, Stefan J.M. ; et
al. |
July 14, 2005 |
Transoral endoscopic gastroesophageal flap valve restoration
device, assembly, system and method
Abstract
The invention provides a device, assembly, and method for
transoral endoscopic restoration of a gastroesophageal flap valve.
The invention also provides a self-steering and self-closing tissue
fixation device for tissue fixation, and an invaginator device for
gripping and maneuvering tissue. The restoration device includes a
longitudinal member arranged for transoral placement into a
stomach, a tissue shaper carried on the longitudinal member that
causes stomach tissue to assume a shape related to a
gastroesophageal flap, and a tissue fixation device that maintains
the shaped stomach tissue in a shape approximating a
gastroesophageal flap. The tissue shaper may include a mold. The
gastroesophageal flap may have a length greater than two
centimeters and sufficient to cover its associated stomach
opening.
Inventors: |
Kraemer, Stefan J.M.;
(Seattle, WA) ; Adams, John M.; (Sammamish,
WA) ; Vincent, Stephen T.; (Kirkland, WA) |
Correspondence
Address: |
Richard O. Gray, Jr.
GRAYBEAL JACKSON HALEY LLP
Suite 350
155 - 108th Avenue NE
Bellevue
WA
98004-5973
US
|
Assignee: |
EsophyX, Inc.
|
Family ID: |
29419321 |
Appl. No.: |
11/001687 |
Filed: |
November 30, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11001687 |
Nov 30, 2004 |
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10921787 |
Aug 18, 2004 |
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11001687 |
Nov 30, 2004 |
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10150740 |
May 17, 2002 |
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6790214 |
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Current U.S.
Class: |
606/139 |
Current CPC
Class: |
A61B 17/07207 20130101;
A61B 17/0644 20130101; A61B 2017/07214 20130101; A61B 2017/306
20130101; A61B 2017/00867 20130101; A61B 2017/003 20130101; A61B
17/068 20130101; A61B 17/00234 20130101; A61B 2017/00827 20130101;
A61B 2017/2905 20130101; A61B 2017/2926 20130101 |
Class at
Publication: |
606/139 |
International
Class: |
A61B 017/10 |
Claims
1-30. (canceled)
31. A transoral gastroesophageal flap valve restoration device, the
device comprising: a longitudinal member, a portion of which is
arranged for transoral placement through an esophagus and into a
stomach substantially in line with the esophagus; a tissue shaper
carried on the longitudinal member that shapes stomach tissue to
assume a shape of a restored gastroesophageal flap; a tissue
gripper arranged to extend away from the longitudinal member, to
grip stomach tissue at a location displaced from the longitudinal
member, and to pull gripped stomach tissue into the tissue shaper
immediately adjacent the longitudinal member; and a tissue fixation
device that maintains the restored gastroesophageal flap.
32. The device of claim 31, wherein the tissue gripper is arranged
to pull the gripped stomach tissue in an aboral direction into the
tissue shaper.
33. The device of claim 31, wherein the tissue shaper comprises
first and second opposed members arranged to receive the gripped
tissue there between.
34. The device of claim 33, wherein the first and second members
are hingedly coupled together.
35. The device of claim 31, wherein the gripper is arranged to grip
the stomach tissue at a distance from the longitudinal member which
is greater then two centimeters.
36. The device of claim 35, wherein the distance is greater than
four centimeters.
37. The device of claim 35, wherein the distance is between four
and five centimeters.
38. The device of claim 31, wherein the shaper is carried on the
distal end of the longitudinal member.
39. A method of transoral restoration of a gastroesophageal flap
valve, the method including the steps of: gripping stomach tissue
from within the stomach at a location displaced from the esophageal
opening to the stomach; pulling the gripped stomach tissue in a
direction aboral of the esophageal opening and into a position
juxtaposed to the esophageal opening; shaping the tissue into a
shape resembling a gastroesophageal flap; and fixating the shaped
tissue into a shape approximating a restored gastroesophageal
flap.
40. The method of claim 39, wherein the gripping step includes
gripping the stomach tissue at a location which is greater then two
centimeters from the esophageal opening.
41. The method of claim 39, wherein the gripping step includes
gripping the stomach tissue at a location which is greater then
four centimeters from the esophageal opening.
42. The method of claim 39, wherein the gripping step includes
gripping the stomach tissue at a location which is between four and
five centimeters from the esophageal opening.
43. The method of claim 39, wherein the fixating step includes
stapling.
Description
RELATED APPLICATION DATA
[0001] The present patent application is a continuation-in-part
application of U.S. patent application Ser. No. 10/150,740, filed
May 17, 2002.
FIELD OF THE INVENTION
[0002] The present invention generally relates to a device,
assembly, system, and method for treating gastroesophageal reflux
disease by restoring the gastroesophageal flap valve. The present
invention more particularly relates to restoring the
gastroesophageal flap valve by drawing gastric tissue into a shape
approximating a normal gastroesophageal flap and fixing the tissue
into that shape.
BACKGROUND
[0003] Gastroesophageal reflux disease (GERD) is a chronic
condition caused by the failure of the anti-reflux barrier located
at the gastroesophageal junction to keep the contents of the
stomach from splashing into the esophagus. The splashing is known
as gastroesophageal reflux. The stomach acid is designed to digest
meat, and will digest esophageal tissue when persistently splashed
into the esophagus.
[0004] FIG. 1 is a front cross-sectional view of the
esophageal-gastro-intestinal tract 40 from a lower portion of the
esophagus 41 to the duodenum 42. The stomach 43 is characterized by
the greater curvature 44 on the anatomical left side and the lesser
curvature 45 on the anatomical right side. The fundus 46 of the
greater curvature 44 forms the superior portion of the stomach 43,
and traps gas and air bubbles for burping. The esophageal tract 41
enters the stomach 43 at a point below the superior portion of the
fundus 46, forming a cardiac notch 47 and an acute angle with
respect to the fundus 46 known as the Angle of His 57. The lower
esophageal sphincter (LES) 48 is a discriminating sphincter able to
distinguish between burping gas, liquids, and solids, and works in
conjunction with the fundus 46 to burp. The gastroesophageal flap
valve (GEFV) 49 includes a moveable portion and an opposing more
stationary portion. The moveable portion of the GEFV 49 is an
approximately 180 degree, semicircular, gastroesophageal flap 50
(alternatively referred to as a "normal moveable flap" or "moveable
flap") formed of tissue at the intersection between the esophagus
41 and the stomach 43. The opposing more stationary portion of the
GEFV 49 comprises a portion of the lesser curvature 45 of the
stomach 43 adjacent to its junction with the esophagus 41. The
gastroesophageal flap 50 of the GEFV 49 principally comprises
tissue adjacent to the fundus 46 portion of the stomach 43, is
about 4 to 5 cm long (51) at its longest portion, and the length
may taper at its anterior and posterior ends. The gastroesophageal
flap 50 is partially held against the lesser curvature 45 portion
of the stomach 43 by the pressure differential between the stomach
43 and the thorax, and partially by the resiliency and the
anatomical structure of the GEFV 49, thus providing the valving
function. The GEFV 49 is similar to a flutter valve, with the
gastroesophageal flap 50 being flexible and closeable against the
other more stationary side.
[0005] The esophageal tract is controlled by an upper esophageal
sphincter (UES) near the mouth for swallowing, and by the LES 48
and the GEFV 49 at the stomach. The normal antireflux barrier is
primarily formed by the LES 48 and the GEFV 49 acting in concert to
allow food and liquid to enter the stomach, and to considerably
resist reflux of stomach contents into the esophagus 48 past the
gastroesophageal tissue junction 52. Tissue aboral of the
gastroesophageal tissue junction 52 is generally considered part of
the stomach because the tissue protected from stomach acid by its
own protective mechanisms. Tissue oral of the gastroesophageal
junction 52 is generally considered part of the esophagus and it is
not protected from injury by prolonged exposure to stomach acid. At
the gastroesophageal junction 52, the juncture of the stomach and
esophageal tissues form a zigzag line, which is sometimes referred
to as the "Z-line." For the purposes of these specifications,
including the claims, "stomach" means the tissue aboral of the
gastroesophageal junction 52. As pressure in the stomach 43
increases, the pressure tightly closes the normal gastroesophageal
flap 50 of the GEFV 49 against the lesser curve portion 45 of the
stomach. The tissues are tightly opposed preventing reflux. The
stomach 43 provides for burping by the diaphragm 53 pushing down on
and flattening the fundus 46, temporarily resulting in the cardiac
notch 47 being straightened and the Angle of His 57 becoming less
acute. The normal gastroesophageal flap 50 of the GEFV 49 opens to
allow the burp to pass into the esophagus 41.
[0006] FIG. 2 is a front cross-sectional view of the
esophageal-gastro-intestinal tract 40 illustrating a Grade I normal
appearance movable flap 50 of the GEFV 49 and a Grade IV reflux
appearance gastroesophageal flap 55 of the GEFV 49. A principal
reason for regurgitation associated with GERD is the mechanical
failure of the deteriorated (or reflux appearance) gastroesophageal
flap 55 of the GEFV 49 to close and seal against the high pressure
in the stomach. Due to reasons including lifestyle, a Grade I
normal gastroesophageal flap 50 of the GEFV 49 may deteriorate into
a Grade IV deteriorated (or reflux appearance) gastroesophageal
flap 55. The anatomical results of the deterioration include moving
a portion of the esophagus 41 that includes the gastroesophageal
junction 52 and LES 48 toward the mouth, straightening of the
cardiac notch 47, and increasing the Angle of His 57. This
effectively reshapes the anatomy aboral of the gastroesophageal
junction 52 and forms a flattened fundus 56. The deteriorated
gastroesophageal flap 55 illustrates a gastroesophageal flap valve
49 and cardiac notch 47 that have both significantly degraded. Dr.
Hill and colleagues developed a grading system to describe the
appearance of the GEFV and the likelihood that a patient will
experience chronic acid reflux. L. D. Hill, et al., The
gastroesophageal flap valve: in vitro and in vivo observations,
Gastrointestinal Endoscopy 1996: 44: 541-547. Under Dr. Hill's
grading system, the normal movable flap 50 of the GEFV 49
illustrates a Grade I flap valve that is the least likely to
experience reflux. The deteriorated gastroesophageal flap 55 of the
GEFV 49 illustrates a Grade IV flap valve that is the most likely
to experience reflux. Grades II and III reflect intermediate grades
of the likelihood of experiencing reflux. In the Grade IV condition
with the deteriorated GEFV represented by deteriorated
gastroesophageal flap 55 and the fundus 46 moved inferior, the
stomach contents are presented a funnel-like opening directing the
contents into the esophagus 41.
[0007] With the deteriorated gastroesophageal flap 55, the stomach
contents are more likely to be regurgitated into the esophagus 41,
the mouth, and even the lungs. The LES 48 by itself is relatively
weak and does not provide sufficient resistance to prevent reflux
or regurgitation by itself. The regurgitation is referred to as
"heartburn" because the most common symptom is a burning discomfort
in the chest under the breastbone. Burning discomfort in the chest
and regurgitation (burping up) of sour-tasting gastric juice into
the mouth are classic symptoms of gastroesophageal reflux disease
(GERD). When stomach acid is regurgitated into the esophagus, it is
usually cleared quickly by esophageal contractions and esophageal
clearance, a combination of esophageal contractions and
down-washing of neutral saliva. Heartburn (backwashing of stomach
acid and bile onto the esophagus 41) results when stomach acid is
frequently regurgitated into the esophagus 41, or if it is not
promptly cleared. Chronic heartburn or GERD occurs because of a
mechanical failure by the deteriorated gastroesophageal flap 55 of
the GEFV 49 and the LES 48 to keep stomach acid and digestive
juices out of the esophagus 41. The GEFV 49 and LES 48 fail to
maintain the normally higher pressure in the stomach 43 and keep
stomach contents out of the esophagus 41. People with a normal
movable flap 50 may experience occasional transient GEFV 49 and LES
48 relaxations that lead to backwashing of stomach contents onto
the esophagus 41. These transient relaxations account for most of
the gastroesophageal reflux episodes and occasional symptoms in
people with a normal gastroesophageal flap 50. However, because the
deteriorated gastroesophageal flap 55 of GEFV 49 and the LES 48 are
not mechanically able to maintain the normal pressure in the
stomach 43, the stomach contents more readily and regularly bathe
the esophagus 41. The esophageal contractions alone are not strong
enough to adequately "strip" the stomach contents out of the
esophagus 41, leading to prolonged acid and bile exposure in the
esophagus. This prolonged exposure allows injury to the normal
squamous lining of the esophagus to occur, resulting in esophagitis
and in some people, healing of the esophagus with the development
of a new lining, called Barrett's Esophagus.
[0008] Complications develop for some people who have GERD.
Esophagitis (inflammation of the esophagus) with erosions and
ulcerations (breaks in the lining of the esophagus) can occur from
repeated and prolonged acid exposure. If these breaks are deep,
bleeding or scarring of the esophagus with formation of a stricture
(narrowing of the esophagus) can occur. If the esophagus narrows
significantly, then food sticks in the esophagus and the symptom is
known as dysphagia. GERD has been shown to be one of the most
important risk factors for the development of esophageal
adenocarcinoma. In a subset of people who have severe GERD, if acid
exposure continues, the injured squamous lining is replaced by
Barrett's metaplasia (Barrett's Esophagus), a precancerous lining
in which esophageal adenocarcinoma can develop. To date, no one
knows precisely yet what causes Barrett's Esophagus.
[0009] Other complications of GERD may not appear to be related to
esophageal disease at all. Some people with GERD may develop
recurrent pneumonia (lung infection), asthma (wheezing), or a
chronic cough from acid backing up into the esophagus and all the
way up through the upper esophageal sphincter into the lungs. In
many instances, this occurs at night, while the person is sleeping.
Occasionally, a person with severe GERD will be awakened from sleep
with a choking sensation. Hoarseness can also occur due to acid
reaching the vocal cords, causing a chronic inflammation or injury.
Lately dental erosions (destruction of the dental layers close to
the gum line) have been identified as result of chronic nightly
backwash of gastric juices into the mouth. Patients typically awake
from a bitter taste in their mouth and from choking.
[0010] Deteriorated gastroesophageal flap 55 and GERD never improve
without intervention. Both medical and surgical treatments exist
for GERD. Medical therapies include antacids and proton pump
inhibitors. However, the medical therapies only mask the reflux.
Patients still get reflux and perhaps emphysema because of
particles refluxed into the lungs. Barrett's Esophagus results in
about 10-15% of the GERD cases. The esophageal epithelium changes
into tissue that tends to become cancerous from repeated acid
washing despite the medication.
[0011] Several open laparotomy and laparoscopic surgical procedures
are available for treating GERD. One surgical approach is the
Nissen fundoplication. The Nissen approach typically involves a
360-degree wrap of the fundus around the gastroesophageal junction
52. The procedure has a high incidence of postoperative
complications. The Nissen approach creates a 360-degree moveable
flap without a fixed portion. While Nissen reinforces the LES 48,
it does not restore the normal movable flap 50 of GEFV 49. The
patient cannot burp because the fundus 46 was used to make the
repair, and may frequently experience dysphagia. Another surgical
approach to treating GERD is the Belsey Mark IV (Belsey)
fundoplication. The Belsey procedure involves creating a valve by
suturing a portion of the stomach 43 to an anterior surface of the
esophagus 41. It reduces some of the postoperative complications
encountered with the Nissen fundoplication, but still does not
restore the normal movable flap 50 of GEFV 49. None of these
procedures fully restores the normal anatomical anatomy or produces
a normally functioning gastroesophageal junction. Another surgical
approach is the Hill repair. In the Hill repair procedure, the
gastroesophageal junction 52 is anchored to the posterior abdominal
areas, and a 180-degree valve is created by a system of sutures.
The Hill procedure restores the moveable flap 50, the cardiac notch
47 and the Angle of His 57. However, all of these surgical
procedures are very invasive, regardless of whether done as a
laparoscopic or an open procedure.
[0012] New, less surgically invasive approaches to treating GERD
involve transoral endoscopic procedures. One procedure contemplates
a machine device with robotic arms that is inserted transorally
into the stomach 43. While observing through an endoscope, an
endoscopist guides the machine within the stomach 43 to engage a
portion of the fundus 46 with a corkscrew-like device on one arm.
The arm then pulls on the engaged portion to create a flap of
tissue near the deteriorated gastroesophageal flap 55. Another arm
of the machine pinches the base of the flap, and drives staples
and/or sutures through it to secure the flap. The endoscopist
engages additional portions of the fundus 46 and drives additional
staples until the endoscopist is satisfied with the flap produced.
While the pinch-and-staple procedure may provide a measure of
treatment in appropriate hands, it neither fully restores the
normal gastroesophageal flap valve anatomy nor produces a normally
functioning gastroesophageal junction 52. Instead, the procedure
only creates a tissue bulge that may assist in limiting reflux.
Furthermore, this procedure is highly dependent on the skill,
experience, aggressiveness, and courage of the endoscopist. A more
timid endoscopist may take only small bites of tissue, and as a
result may not successfully create a flap that functions as a
normal movable flap 50. Every flap built with this procedure will
be different because it depends so much on the skill, experience
and courage of the physician. Another transoral procedure
contemplates making a fold of fundus tissue near the deteriorated
gastroesophageal flap 55 to recreate the LES. The procedure
requires placing multiple U-shaped tissue clips around the folded
fundus to hold it in shape and in place. Like the previously
discussed procedure, this procedure is also highly dependent on the
skill, experience, aggressiveness, and courage of the endoscopist.
In addition, these and other procedures may involve esophageal
tissue in the repair. Esophageal tissue is fragile and weak, and
involvement of esophageal tissue in the repair of a
gastroesophageal flap valve poses unnecessary risks to the
patient.
[0013] Present and emerging methods all depend on the skill,
experience, and aggressiveness of the endoscopist to grasp the
appropriate amount of stomach or esophagus tissue to build the
depth and width of the structure contemplated. This results in
non-uniformity from patient to patient and non-uniformity from
endoscopist to endoscopist. There is a need for a highly
standardized and uniform device and procedure for restoring the
natural gastroesophageal flap valve and a normally functioning
gastroesophageal junction.
[0014] In view of the foregoing, there is a need in the art for a
new and improved apparatus and method for restoration of a
gastroesophageal flap valve. The present invention is directed to a
device, system, and method that provide such an improved apparatus
and method for restoration of a gastroesophageal flap valve.
SUMMARY
[0015] The invention provides a transoral gastroesophageal flap
valve restoration device. The device includes a longitudinal member
arranged for transoral placement into a stomach, a tissue shaper
carried on the longitudinal member that causes stomach tissue to
assume a shape of a restored gastroesophageal flap, and a tissue
fixation device that maintains the restored gastroesophageal flap.
The tissue shaper has a length sufficient to in turn cause the
restored gastroesophageal flap to have a length sufficient to cover
its associated stomach opening. The shaper may thus have a length
greater than two centimeters to in turn cause the restored
gastroesophageal flap to have a length greater than two
centimeters.
[0016] In accordance with another embodiment, the present invention
provides a method of transoral restoration of a gastroesophageal
flap valve. The method includes the steps of pulling stomach tissue
into a tissue shaper having a length greater than two centimeters,
shaping the tissue into a shape resembling a gastroesophageal flap
having a length greater than two centimeters, and fixating the
shaped tissue into a shape approximating a restored
gastroesophageal flap having a length greater than two
centimeters.
[0017] The invention further provides a transoral gastroesophageal
flap valve restoration device. The device comprises a longitudinal
member, a portion of which is arranged for transoral placement into
a stomach, a tissue shaper carried on the longitudinal member that
causes stomach tissue to assume a shape of a restored
gastroesophageal flap, the tissue shaper having a length greater
than two centimeters to cause the restored gastroesophageal flap to
have a length greater than two centimeters, and a tissue fixation
device that maintains the restored gastroesophageal flap having a
length greater than two centimeters.
[0018] The tissue shaper preferably has a length greater than four
centimeters, as for example, between four and five centimeters.
Also preferably, a portion of the device is substantially
transparent.
[0019] The device further comprises a tissue gripper arranged to
extend away from the longitudinal member to grip and pull stomach
tissue into the tissue shaper aboral of the Z line. The tissue
gripper is preferably arranged to extend two to six centimeters
away from the longitudinal member.
[0020] The invention still further provides a transoral
gastroesophageal flap valve restoration device comprising a
longitudinal member, a portion of which is arranged for transoral
placement into a stomach, and that carries a mold having a surface
shape related to a gastroesophageal flap and a tissue shaper that
non-invasively grips and urges stomach tissue into contact with the
mold. The device further comprises a tissue fixation device that
maintains the molded stomach tissue in a shape approximating a
restored gastroesophageal flap. The mold has a length to cause the
restored gastroesophageal flap to be of sufficient length to cover
an associated stomach opening.
[0021] The mold has a length greater than two centimeters.
Preferably, the mold has a length between four and five
centimeters. The tissue shaper preferably includes a tissue gripper
that pulls the tissue into contact with the mold. The longitudinal
member may include a channel arranged to maintain an orientation
with an endoscope.
[0022] The invention further provides a method of transoral
restoration of a gastroesophageal flap valve. The method includes
the steps of pulling stomach tissue into a tissue shaper having a
length greater than two centimeters, shaping the tissue into a
shape resembling a gastroesophageal flap having a length greater
than two centimeters, and fixating the shaped tissue into a shape
approximating a restored gastroesophageal flap having a length
greater than two centimeters.
[0023] The invention still further provides a transoral
gastroesophageal flap valve restoration device comprising a
longitudinal member, a portion of which is arranged for transoral
placement through an esophagus and into a stomach and a tissue
shaper carried on the longitudinal member that shapes stomach
tissue to assume a shape of a restored gastroesophageal flap. The
device further includes an invaginator that moves the esophagus
towards the stomach and holds the esophagus as the tissue shaper
shapes the stomach tissue, and a tissue fixation device that
maintains the restored gastroesophageal flap.
[0024] A portion of the device is preferably formed of a material
which is substantially transparent. The portion of the device
formed of a material which is substantially transparent may include
the tissue shaper and/or the invaginator.
[0025] The device may further comprise a tissue gripper arranged to
extend away from the longitudinal member and to grip and pull
stomach tissue into the tissue shaper aboral of the Z line. The
tissue gripper is preferably arranged to extend two to six
centimeters away from the longitudinal member.
[0026] The invention still further provides a method of transoral
restoration of a gastroesophageal flap valve. The method comprises
diagnosing a Grade II, III, or IV flap valve, selecting a portion
of intraluminal fundus tissue that is proximate to an associated
cardiac notch, shaping the tissue into a shape resembling a
gastroesophageal flap having a length greater than two centimeters,
and fixating the shaped tissue into a shape approximating a
gastroesophageal flap having a length greater than two
centimeters.
[0027] The invention still further provides a method of restoring a
gastroesophageal flap of a stomach. The method comprises shaping,
aboral of a Z line associated with the stomach, stomach tissue into
a shape that approximates a gastroesophageal flap, and fixating,
aboral of the Z line, the shaped stomach tissue that approximates a
gastroesophageal flap.
[0028] The method may include the further steps of gripping an
inner surface of an esophagus associated with the stomach, moving
the gripped esophagus towards the stomach, and holding the
esophagus stationary as the stomach tissue is shaped and fixated.
The step of gripping may include gripping the esophagus with a
vacuum through a plurality of orifices. The shaped stomach tissue
preferably approximates a gastroesophageal flap having a length
greater than two centimeters.
[0029] The device may include a portion formed of substantially
transparent material, and the method may include the further step
of viewing one of the stomach and esophagus through the device with
an endoscope. The step of fixating may include pushing at least one
fastener from the device into the stomach tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] The features of the present invention which are believed to
be novel are set forth with particularity in the appended claims.
The invention, together with further objects and advantages
thereof, may best be understood by making reference to the
following description taken in conjunction with the accompanying
drawings, in the several figures of which like referenced numerals
identify like elements, and wherein:
[0031] FIG. 1 is a front cross-sectional view of the
esophageal-gastro-intestinal tract from a lower portion of the
esophagus to the duodenum;
[0032] FIG. 2 is a front cross-sectional view of the
esophageal-gastro-intestinal tract illustrating a Grade I normal
appearance movable flap of the gastroesophageal flap valve and a
Grade IV reflux appearance gastroesophageal flap of the
gastroesophageal flap valve;
[0033] FIG. 3 is a perspective partial-sectional view of a
gastroesophageal flap valve restoration assembly including a mold
of the normal movable flap according to an embodiment of the
invention;
[0034] FIG. 4 is a plan view of a self-steering and self-closing
tissue fixation device according to an embodiment of the
invention;
[0035] FIG. 5 is a side view of the self-steering and self-closing
tissue fixation device of FIG. 4 carried in a lumen, and in its
initial stressed and distorted configuration;
[0036] FIGS. 6-9 illustrate sequential configurations of the
self-steering and self-closing tissue fixation device as it is
deployed and moves from an initial configuration to a final
configuration;
[0037] FIG. 10 is a perspective cross-sectional view of the
gastroesophageal flap valve restoration assembly of FIG. 3 being
used to transorally restore a gastroesophageal flap valve employing
an endoscopic visualization device, according to an embodiment of
the invention;
[0038] FIG. 11 is a perspective cross-sectional view of a restored
gastroesophageal flap and a restored gastroesophageal flap valve
according to an embodiment of the invention;
[0039] FIG. 12 is a perspective partial cross-section view of an
invaginator device according to an embodiment of the invention;
[0040] FIG. 13 is a perspective cross-sectional view of the
gastroesophageal flap valve restoration assembly of FIG. 3 and the
invaginator assembly of FIG. 12 being used to transorally restore a
gastroesophageal flap valve employing an endoscopic visualization
device, according to an embodiment of the invention;
[0041] FIG. 14 is a perspective partial-sectional view of a
gastroesophageal flap valve restoration assembly with a moveable
tissue gripper in an extended configuration, according to an
embodiment of the invention;
[0042] FIG. 15 is a cross-sectional plan view of the mold of FIG.
14;
[0043] FIG. 16 is a perspective partial-sectional view of a
gastroesophageal flap valve restoration assembly of FIG. 14 with
the moveable tissue gripper in a retracted/molding configuration,
according to an embodiment of the invention;
[0044] FIGS. 17-22 are sequential, schematic cross-sectional views
illustrating the gastroesophageal flap valve restoration assembly
of FIGS. 14-16 being used to transorally restore a gastroesophageal
flap valve, according to an embodiment of the invention;
[0045] FIG. 23 is a perspective partial-sectional view of a
gastroesophageal flap valve restoration assembly with a tissue
gripper guide in its retracted/molding configuration, according to
an embodiment of the invention;
[0046] FIG. 24 is a cross-sectional view illustrating the
gastroesophageal flap valve restoration assembly of FIG. 23 being
used to transorally restore a gastroesophageal flap valve,
according to an embodiment of the invention;
[0047] FIG. 25 is perspective partial-sectional view of a
gastroesophageal flap valve restoration assembly of FIGS. 14-16
arranged to engage an extracorporeal portion of an endoscopic
device when a portion of the endoscopic device is in vivo,
according to an embodiment of the invention;
[0048] FIG. 26 is a perspective partial cross-sectional view of
gastroesophageal flap valve restoration assembly of FIG. 25;
and
[0049] FIGS. 27-31 are more detailed sequential, cross-sectional
views illustrating the assembly of FIGS. 14-16 in restoring a
gastroesophageal flap valve.
DETAILED DESCRIPTION
[0050] In the following detailed description of exemplary
embodiments of the invention, reference is made to the accompanying
drawings, which form a part hereof. The detailed description and
the drawings illustrate specific exemplary embodiments by which the
invention may be practiced. These embodiments are described in
sufficient detail to enable those skilled in the art to practice
the invention. It is understood that other embodiments may be
utilized, and other changes may be made, without departing from the
spirit or scope of the present invention. The following detailed
description is therefore not to be taken in a limiting sense, and
the scope of the present invention is defined only by the appended
claims.
[0051] The meaning of "a", "an", and "the" include plural
references. The meaning of "in" includes "in" and "on."
Additionally, a reference to the singular includes a reference to
the plural unless otherwise stated or inconsistent with the
disclosure herein.
[0052] FIG. 3 is a perspective partial-sectional view of a
gastroesophageal flap valve restoration assembly 60 including a
mold of the normal movable flap 70 (hereafter "mold") 70 according
to an embodiment of the invention. The GEFV restoration assembly 60
includes a longitudinal member 62, an extracorporeal movement
control member 64, an endoscopic channel 66, a pressurized air port
68, a vacuum port 69, a mold 70 having a molding surface 72, a
tissue shaper 73, a plurality of tissue fixation devices 80a, 80c,
and 80e, a plurality of lumens 82a-e, and a plurality of lumen
orifices 84a-e.
[0053] Longitudinal member 62 is a flexible structure dimensioned
and structured for transoral placement into the esophagus and
stomach, and includes the endoscopic channel 66 and the
extracorporeal movement control member 64. Endoscopic channel 66 is
arranged to at least partially surround a length of the shaft of an
endoscopic device, maintain an orientation to the shaft, and be
movable along the shaft. Longitudinal member 62 also includes the
plurality of lumens 82a-e, each arranged to carry at least one
tissue fixation device for deployment from the orifice of the
lumen. FIG. 3 illustrates longitudinal member 62 carrying tissue
fixation devices 80a, 80c, and 80e for deployment from the lumen
orifices 84a, 84c, and 84e. In alternative embodiments, greater or
fewer lumens 82 may be employed, and one lumen 82 may be arranged
to deploy a plurality of tissue fixation devices 80. In a further
alternative embodiment, the tissue fixation devices 80 may be
carried in a chamber or a plurality of chambers, and deployed from
the chambers. Longitudinal member 62 has sufficient flexibility for
transoral placement into the stomach, and sufficient rigidity to
manipulate structures carried by it. Longitudinal member 62 may be
made from any material suitable for gastroesophageal surgical use,
and suitable materials include any biocompatible material known in
the art.
[0054] Extracorporeal movement control member 64 is rigidly
attached to longitudinal member 62 and arranged for control of
longitudinal and rotational movements of the longitudinal member
62, and any structures carried by it. While control member 64 is
illustrated as carrying pressurized air port 66 and vacuum port 69,
these ports may be carried on longitudinal member 62 or any other
portion of flap valve restoration assembly 60. Control member 64
may be made from any biocompatible material known in the art.
[0055] Mold 70 is carried on the longitudinal member 62, and
includes the molding surface 72 and the tissue gripper in the form
of the plurality of tissue gripping vacuum orifices 74. The molding
surface 72 has an approximately 180 degree, semicircular shape
related to the normal movable flap 50 of GEFV 49, and resembles a
cupped hand. In an embodiment, the molding surface 72 is formed to
replicate the normal gastroesophageal flap 50. Observations of the
normal gastroesophageal flap 50 have shown that the appearance,
dimensions, and configuration do not vary significantly between
people. Molding surface 72 is arranged to mold stomach tissue for
fixation, such that when the molded stomach tissue is fixated and
released from the mold 70, the molded stomach tissue has a shape
and functionality approximating the normal gastroesophageal flap 50
of GEFV 49. Mold 70 is removably carried on longitudinal member 62,
allowing for substitution of another mold 70 if it is discovered
that a different molding surface 72 will provide a molded stomach
tissue better approximating a GEFV 49.
[0056] In the embodiment illustrated in FIG. 3, the tissue shaper
73 includes a plurality of tissue gripping vacuum orifices 74 that
cause stomach tissue to assume a shape related to the normal
gastroesophageal flap 50 of GEFV 49. The vacuum orifices 74 are
disposed on at least a portion of the molding surface 72. The
vacuum orifices 74 are arranged to draw and urge selected proximate
stomach tissue into the mold 70 and to form a molded stomach tissue
125 in a shape related to the normal gastroesophageal flap 50 of
GEFV 49 in response to the molding surface 72. Vacuum orifices 74
are coupled to a vacuum source by the vacuum port 69 and by a
vacuum lumen 79. The vacuum level at the vacuum orifices 74 is
controlled by a regulator (not shown).
[0057] Mold 70 has a first configuration for transoral placement
into proximity to the gastroesophageal junction, the placement
being most likely into the stomach 43. The first configuration is a
collapsed shape sized for the transoral placement. In an preferred
embodiment, the collapsed shape maintains the endoscopic channel 66
so that the collapsed flap valve restoration assembly 60 may be
transorally guided by an endoscope with its distal end placed in
the stomach 43. Mold 70 has a second configuration, which has a
shape related to the normal gastroesophageal flap 50 of GEFV 49 as
illustrated in FIG. 3. Mold 70 is moved from the first
configuration to the second configuration in vivo. Methods for
moving from the first configuration to the second configuration
include applying pressurized air to inflate mold 70, and a
mechanical means. If the mold 70 is moved from the first
configuration to the second configuration by applying pressurized
air, flap valve restoration assembly 60 includes a pressurized air
port 68 and a regulator (not shown) to provide a controlled air
pressure, and an inflatable member (not shown). The inflatable
member is coupled to the controlled air pressure by an air pressure
lumen (not shown), and application of air pressure causes the mold
70 to move from the first configuration to the second
configuration. Mold 70 is arranged to move from the second
configuration to a third configuration for removal from the
patient. The third configuration may be similar to the first
configuration, or may be dissimilar. For example, mold 70 could
move from the first configuration to the second configuration like
an umbrella being unfolded. For transoral removal, mold 70 could
then move back to the first configuration, or move to new
configuration like an umbrella folded back in the wind. In an
alternative embodiment, mold 70 comprises a material that may be
passed "per vias naturales," and the third configuration includes
releasing the mold 70 from the longitudinal member 62 into the
stomach for passage "per vias naturales." Mold 70 is made from any
biocompatible material known in the art. When arranged for passage
"per vias naturales," the mold 70 may include a material that is
degradable or digestible within the digestive system and passed out
of the body, or simply passed out of the body.
[0058] In a preferred embodiment, the portion of the mold having a
shape related to the GEFV is transparent so the endoscopist may
visually confirm the shape of the molded stomach tissue prior to
deploying the tissue fixation devices 82. In another alternative
embodiment, the plurality of lumens 82a-e and lumen orifices 84a-e
may be included in the mold 70 instead of longitudinal member
62.
[0059] In an alternative embodiment, the mold 70 may be coupled to
an endoscopic device, and the endoscopic device used to maneuver
the mold 70.
[0060] The next series of figures relate to the tissue fixation
device, which is a self-steering and self-closing tissue fixation
device in a preferred embodiment. FIG. 4 is a plan view of a
self-steering and self-closing tissue fixation device (hereafter
"tissue fixation device 80") according to an embodiment of the
invention. FIG. 5 is a side view of the tissue fixation device of
FIG. 4 carried in a lumen 82 and in its initial stressed and
distorted configuration 100, according to an embodiment of the
invention. FIGS. 6-9 illustrate sequential configurations of the
tissue fixation device 80 as it is deployed and moves from an
initial configuration 100 to a final configuration 115, according
to an embodiment of the invention. Tissue fixation device 80
includes an elongated member 90, a first end portion 91, a second
end portion 92, a connecting portion 93, a tissue-piercing end 94,
a first joining portion 95, a second joining portion 96, a pressure
portion 97, and a push-receiving end 98.
[0061] The elongated member 90 includes a biocompatible material
having properties that allow it to move from a first configuration
to a second configuration, typically upon release of a stress or
distortion, or upon a change in temperature. Suitable materials
include materials having superelastic properties, shape memory
properties, or both. These materials include Nitinol that has both
a shape memory and superelastic properties, and plastics having
shape memory properties. The elongated member 90 is formed such
that it has an initial stressed and distorted configuration 100,
and a final configuration 110 arranged to hold together tissue
enclosed within an interior perimeter 105. The overall length and
thickness of the elongated member 90 are selected to provide the
desired fixation by the elongated member 90. For example, the
length of the portions may be selected depending on the type and
thickness of the tissue fold 115 to be fixated and the amount of
fixation force to be provided. The thickness of the elongated
member 90 may be selected based on the amount of fixation force to
be provided. The thickness may be between approximately 0.010 and
0.050 of an inch. Furthermore, the desired shape of the final
configuration 110 may also determine the length of the portions and
the thickness of the material, as well as the amount of bend
between the portions in the final configuration 110. In alternative
embodiments, the shape of the final configuration 110 may be
generally rectangular, round, oval or mound. In a further
alternative embodiment, the shape of the final configuration may
generally be a spiral.
[0062] The initial stressed and distorted configuration 100 is
arranged such that, as the portions beginning with the first end
portion 91 are deployed from the lumen orifice 84 by a force
imparted by push rod 99 on the push receiving end 98 of the second
end portion 92, the superelastic and/or shape memory properties of
tissue fixation device 80 steer the elongated member 90 into and
through a fold of tissue 115 proximate to the lumen 84. In an
alternative embodiment, the structure from which the tissue
fixation device 80 is deployed may be arranged to provide at least
part of the steering of elongated member 80. The deployment of
tissue fixation device 80 is illustrated in FIGS. 6-9. Upon being
completely pushed from the lumen 82, elongated member 90
self-closes to assumes a final configuration 110 illustrated in
FIG. 9. In the final configuration 110, the elongated member 90
forms an interior perimeter 105 holding together the fold of tissue
115 that is enclosed within the perimeter. In the final
configuration 110, the pressure portion 97 opposes the first end
portion 91 and the second end portion 92, fixating the tissue fold
115 between them. The interior perimeter 105 of the final
configuration 110 may close only to the degree necessary to provide
the desired fixation. In an alternate embodiment, the first end
portion 91 is proximate to second end portion 92 in the final
configuration 110 as illustrated in FIG. 9. In a further
alternative embodiment, the elongated member 90 forms a
substantially enclosed perimeter in the final configuration
110.
[0063] FIG. 10 is a perspective cross-sectional view of the GEFV
restoration assembly 60 of FIG. 3 being used to transorally restore
a gastroesophageal flap valve employing an endoscopic visualization
device 120, according to an embodiment of the invention. Endoscopic
visualization is used in a preferred embodiment of restoring a
GEFV. In other preferred embodiments, other visualization
techniques may be used such as a fluoroscope or a swallowable
camera. As shown in FIG. 10, a first step in transorally restoring
a GEFV includes advancing a flexible endoscope 120 into the stomach
43 by way of the esophagus 41. The endoscope 120 is retroflexed so
that the viewing element in the distal end 122 shows the area where
the esophagus 41 joins the stomach 43. Viewing endoscopes are well
known in the art, and are typically equipped with a lighting
element and a viewing element enabling the operator to view the
interior of a body cavity, such as the stomach 43 in this case. For
the purposes of the embodiment of the invention illustrated in FIG.
10, the endoscopic visualization device (hereafter "endoscope") 120
may be an instrument separate from the other devices used to
transorally restore a gastroesophageal flap valve. The endoscope
120 may work cooperatively with the other devices used to
transorally restore a gastroesophageal flap valve, for example
guiding the longitudinal member 62.
[0064] In an initial step, the longitudinal member 62 carrying the
mold 70 is slid over the shaft of the endoscope 120 and placed near
the proximal end of the endoscope 120. In another step, the viewing
element of distal end 122 of the endoscope 120 is placed into the
stomach 43, and retroflexed to provide viewing of the area where
the esophagus 41 joins the stomach 43. The GEFV mold 70, in its
first configuration for transoral placement, is lowered into the
stomach 43 by sliding the longitudinal member 62 along the shaft of
the endoscope 120 as a guide. Once in the stomach 43, the GEFV 70
mold is moved from its first configuration to its second
configuration having a shape related to the GEFV 49. Another step
includes moving the mold 70 (in its second configuration) along the
shaft of the endoscope 120 upward toward the patient's head and the
esophagus 41 in the direction indicated by molding movement arrow
123, to a position where the mold 70 is proximate to the
deteriorated gastroesophageal flap 55 (not shown) and a portion of
the fundus 46 proximate to the cardiac notch 47. This movement is
performed under visualization with the endoscope 120. A vacuum is
applied to the vacuum lumen 79 and to the plurality of tissue
gripping vacuum orifices 74. The vacuum orifices 74 grip, urge, and
draw in a fold of musculo-mucosal tissue 115 into the mold 70, and
hold the fold of tissue 115 against the molding surface 72. This
molds the fold of tissue 115 into a shape related to a
gastroesophageal flap (hereafter "molded stomach tissue") 125, such
as the normal gastroesophageal flap 50 of GEFV 49. Typically, the
fold of tissue 115 will include tissue of the wall of the fundus 46
near the cardiac notch 47 folded against the adjacent portion of
the esophagus 41. While the fold of tissue 115 is illustrated as a
fold of an entire thickness of tissue, the fold of tissue 115 may
include less than the entire thickness of tissue, such as one or
two layers. Prior to fixating the molded stomach tissue 125, the
molded stomach tissue 125 may be viewed through a transparent
portion of the mold 70 with the endoscope 120 to confirm that it
meets the expectations of the endoscopist.
[0065] To fixate and secure the molded stomach tissue 125 in a
shape approximating a gastroesophageal flap valve, at least one
tissue fixation device 80 is deployed from the lumen orifice 84 in
the manner described in conjunction with FIGS. 5-9. The tissue
fixation devices 80 are typically preloaded into the lumens 82 of
longitudinal member 62 prior to insertion of the mold 70 into the
stomach 43. Typically, more than one tissue fixation device 80 is
used. In an alternative embodiment, the tissue fixation devices 80
are deployed in a pattern to provide optimal fixation, such as an
"M" or "C" or any other pattern, which may be repeated. In an
alternative embodiment, the tissue fixation device is glue, or a
substance provoking tissue regeneration or adhesion, which may be
deployed individually, or in association with the mechanical tissue
fixation devices 80. When used in association, the glue or
provoking substance may be deposited between the tissues of the
fold of tissue 115 to more firmly attach the tissues to each other,
to increase the area of adhesions to improve the fixation, and to
seal off the fixation sites.
[0066] Another step includes moving the mold 70 along the shaft of
the endoscope 120 downward opposite to arrow 123, and toward the
patient's feet and away from the esophagus 41 and the restored
gastroesophageal flap valve, to a position where the fixated molded
stomach tissue 125 may be inspected with the distal end 122 of the
endoscope 120. If upon inspection the endoscopist is not satisfied
that an acceptable restored gastroesophageal flap 127 has been
formed, the mold 70 may be moved back into position for placement
of additional tissue fixation devices 80, or for creating an
additional molded tissue 125 and fixating.
[0067] A final step includes removal of the mold 70 from the
patient. The mold 70 is moved from the second configuration to a
third configuration for transoral removal, and removed from the
patient by removing the longitudinal member 62. In an alternative
embodiment, mold 70 comprises a material that may be passed "per
vias naturales," i.e., by a natural process. The mold 70 is
released from the longitudinal member 62 into the stomach for
passage "per vias naturales," and the longitudinal member 62 is
removed from the patient. In another alternative embodiment, the
mold 70 can be left engaged temporarily with the fixated molded
stomach tissue 125 to support the function of the restored GEFV
129, and protect it during healing. The mold 70 is arranged to
disintegrate within a predetermined over time.
[0068] The steps described above are expected to result in a
relatively uniformly shaped fold of tissue 115 because the mold 70
establishes the size of the fold of tissue 115 and molds the fold
of tissue 115 into the molded stomach tissue 125 that approximates
a normal gastroesophageal flap 50. The endoscopist does not need to
decide how much tissue to take to form the fold of tissue 115
because the mold 70 standardizes and establishes these
parameters.
[0069] The above procedure may also be performed with the
longitudinal member 62 and the mold 70 being used in conjunction
the endoscope 120, but not being moved over or physically guided by
the shaft of the endoscope 120. In alternative embodiments, other
visualization methods may be used, such as fluoroscopy with
appropriate viewing marks on the devices.
[0070] FIG. 11 is a perspective cross-sectional view of a restored
gastroesophageal flap 127 and a restored GEFV 129 according to an
embodiment of the invention. FIG. 11 illustrates the restored
gastroesophageal flap 127 formed by any one of the embodiments of
the invention described herein, as for example the embodiment of
FIG. 10, after the mold 70 and the longitudinal member 62 have been
removed from the vicinity of the gastroesophageal junction. At
least one tissue fixation device 80, and preferably a plurality of
tissue fixation devices 80, maintains the molded stomach tissue 125
as the restored gastroesophageal flap 127. The restored
gastroesophageal flap 50 preferably has a length 151 sufficient to
cover the opening to the stomach. The opening may have, for
example, a 2 cm diameter, but may be even larger in some patients.
Hence, the length 151 is preferably greater than 2 cm. A length
greater than 2 cm, for example, 4 to 5 cm, would nearly assure full
closure functionality for most, if not all, patients. To this end,
the molding surface 72 of mold 70 has a length 153 sufficient to
form a fold of stomach tissue having a length greater than 2 cm, as
for example 4 to 5 cm and hence, has itself a corresponding length
greater than 2 cm, as, for example, 4 to 5 cm. Whenever a Grade II,
III or IV flap valve is diagnosed, a fully functional GEFV must be
restored and have a valve flap that is greater in length than 2 cm,
and preferably 4 to 5 cm. The restored gastroesophageal flap 127
thus approximates the movement and functionality of the normal
gastroesophageal flap 50 and opens and closes against the lesser
curvature 45 portion of the stomach 43 in the manner of the normal
gastroesophageal flap 50 described in conjunction with FIG. 1. The
restored GEFV 129 thus formed then approximates the functionality
of the normal GEFV 49 described in conjunction with FIG. 1. The
molding process described in conjunction with FIG. 10 is expected
to produce a highly standardized procedure and outcome. Another
advantage of the molding process is that the length of the valve
flap may be carefully controlled permitting the functionality of
the normal GEFV 49 to be reestablished upon conclusion of the
procedure. There is no need to wait for adhesion to form a flap, or
for a mounting device to biodegrade.
[0071] In addition to creating a restored gastroesophageal flap 127
and a restored GEFV 129, the embodiment of the invention described
in conjunction with FIG. 10 also restores at least some of the
other deteriorations associated with GERD that are illustrated in
FIG. 2. The creation of the restored GEFV 125 also at least
partially restores the cardiac notch 47 and makes the Angle of His
57 more acute. This moves the superior portion of the fundus 46
toward the mouth and away from where the esophagus 41 enters the
stomach 43, restoring the arch of the normal fundus 46. This is
expected to restore a patient's ability to burp air and gas. This
is further expected to reduce the degree to which stomach contents
reflux into the esophagus because the stomach contents are no
longer presented with a funnel-like structure into the esophagus
41, as is the case with a Grade III or IV reflux appearance
gastroesophageal flap 55.
[0072] FIG. 12 is a perspective partial cross-section view of an
invaginator device 130 according to an embodiment of the invention.
The invaginator device 130 includes an invaginator longitudinal
member 132, an invaginator extracorporeal movement control member
134, an endoscope channel 136, a pressurized air port 138, a vacuum
port 139, an invaginator-longitudinal member coupler 140, an
invaginator surface 142, a longitudinal raised portions 143, a
plurality of tissue gripping vacuum orifices 144, an invaginator
member 146, an inflation member 147, an air pressure lumen 148, and
a plurality of vacuum lumens 149.
[0073] The invaginator assembly 130 is a flexible structure
arranged for gripping the walls of body lumens and hollow body
structures, such as the esophagus and intestines. It is also
arranged for endoscopic placement. The endoscope channel 136 of
longitudinal member 132 is arranged to at least partially surround
a length of the shaft of an endoscopic device, maintain an
orientation relative to the shaft, and be movable along the shaft.
While the invaginator device 130 has broad application for use with
any body lumen or hollow structure, its features will be described
with respect to a preferred embodiment for invaginating esophageal
tissue in conjunction with restoration of a GEFV. Invaginator
assembly 130 is arranged for transoral, endoscopic placement into
the esophagus, and includes the endoscope channel 136 and the
extracorporeal movement control member 134. In addition to being
arranged to surround a length of the shaft of an endoscopic device,
the endoscope channel 136 is also arranged to at least partially
surround a length of the longitudinal member 62 of flap valve
restoration assembly 60 illustrated in FIG. 3, maintain an
orientation to the longitudinal member 62, and be movable along the
longitudinal member 62. Longitudinal member 132 has sufficient
flexibility for transoral placement into the stomach, and
sufficient rigidity to manipulate structures carried by it and
moved in opposition to it. Longitudinal member 62 may be made from
any biocompatible material known in the art.
[0074] The extracorporeal invaginator movement control member 134
is attached to longitudinal member 132 and arranged to control the
movements of the longitudinal member 132 and devices carried by it,
including the invaginator member 146. Control member 134 includes a
pressurized air port 138 and a vacuum port 139. While the control
member 134 is illustrated as carrying the pressurized air port 138
and the vacuum port 139, these ports may be carried on the
invaginator longitudinal member 132 or any other portion of the
invaginator assembly 130. The control member 134 may be made from
any biocompatible material known in the art.
[0075] The invaginator member 146 and its components are coupled to
the invaginator longitudinal member 132 by the
invaginator-longitudinal member coupler 140. The invaginator member
146 may have any shape. In a preferred embodiment, the invaginator
member 146 is a generally cylindrical shape for ease of transoral
insertion, and may include an inflation member 147, an air pressure
lumen 148, and a vacuum lumen 149. The invaginator member 146 also
includes an invaginator surface 142 having a plurality of
longitudinal raised portions 143. At least one longitudinal raised
portion 143 has a tissue gripper in the form of the plurality of
tissue gripping vacuum orifices 144 served by a vacuum lumen 149
underlying the longitudinal raised portion 143. The orifices may
have a diameter between 4 and 8 mm, for example. Only one
longitudinal raised portion 143 is provided reference numbers in
FIG. 12 for clarity. The plurality of tissue gripping vacuum
orifices 144 are arranged to grip tissue by drawing, and tightly
and releasably engaging the esophageal wall with the invaginator
member 146. Once engaged, the invaginator assembly 130 can be used
to impart a force to the vacuum gripped esophagus tissue to urge
the engaged portion of the esophagus 41 in a direction selected by
the endoscopist. The tissue gripping vacuum orifices 144 are
coupled to a vacuum source by the vacuum port 139 and by a vacuum
lumen 149. The vacuum level at the tissue gripping vacuum orifices
144 is controlled by a regulator (not shown). In an alternative
embodiment, the invaginator member 146 may be non-inflatable and
may be only a portion of a generally cylindrically shaped
structure. For example, the invaginator member 146 may be carried
on the longitudinal member 63 of FIG. 3, and arranged to only
engage approximately one-half of the interior perimeter of the
esophagus. In an alternative embodiment, the invaginator tissue
gripper may comprise a peripheral surface arranged to
non-invasively and frictionally engage tissue, such as a fish
scale-like structure similar to that used on the bases of cross
country skis, or a plurality of protrusions.
[0076] Invaginator member 146 has a first configuration for
transoral placement through the mouth, down into the esophagus, and
into proximity to the LES 48. The first configuration is a
collapsed shape dimensioned for transoral placement. In a preferred
embodiment, the collapsed shape maintains the endoscopic channel
136 so that the collapsed invaginator member 146 may be transorally
guided by an endoscope shaft. Invaginator member 146 has a second
configuration, which has a shape related to the cross-sectional
dimensions of the esophagus 41. Invaginator member 146 is moved
from the first configuration to the second configuration in vivo.
Methods for moving from the first configuration to the second
configuration include applying a pressure to expand the inflation
member 147, and a mechanical means. The pressure can be supplied by
compressed air or pressurized fluid. An embodiment of the invention
is illustrated that includes application of air pressure to expand
the inflation member 146 by inflation, and move the invaginator
member 146 from a first configuration to a second configuration.
The invaginator device 130 includes a pressurized air port 138, a
regulator (not shown) to provide a controlled air pressure, and an
inflation member 147. The inflation member 147 is coupled to the
controlled air pressure by an air pressure lumen 148, and
application of air pressure causes the invaginator member 146 to
move from the first configuration to the second configuration. The
invaginator member 146 is arranged to move from the second
configuration to a third configuration for removal from the
patient. The movement to the third configuration may be by
releasing the air pressure from the inflation member 147. The third
configuration may be similar to the first configuration. The
invaginator member 146 is made from any biocompatible material
known in the art. In an alternative embodiment, the invaginator
device 130 may be coupled to an endoscopic device, and the
endoscopic device used to maneuver the invaginator device 130. In a
still further embodiment the invaginator may be formed of a
substantially transparent or transparent material to permit better
visualization during the GEFV restoration procedure. For example,
with partial retraction of the endoscope 120, visualization of the
Z line and/or visualization of the orifices 144 gripping the
esophagus may be achieved. Such visualization would be an aid in
assuring GEFV restoration aboral of the Z line and confirmation of
esophagus fixation.
[0077] FIG. 13 is a perspective cross-sectional view of the GEFV
restoration assembly 60 of FIG. 3 and the invaginator assembly 130
of FIG. 12 being used to transorally restore a gastroesophageal
flap valve employing an endoscopic visualization device 120,
according to an embodiment of the invention. FIG. 13 illustrates
the invaginator device 130 providing movement of and control over
the esophagus 41 in combination with the GEFV restoration assembly
60 for transoral restoration of a gastroesophageal flap valve. The
portions toward the patient's mouth of the shaft of the endoscope
120, the invaginator longitudinal member 132, and the longitudinal
member 62 are truncated in FIG. 13 for clarity. The procedure is
similar to that described in conjunction with FIG. 10. Preferably,
prior to moving the mold 70 toward to the patient's head in the
direction of arrow 123, the invaginator device 130 with the
invaginator member 146 in its first configuration for placement is
lowered into the esophagus 41. The invaginator longitudinal member
132 is engaged with and slid along the shaft of the endoscope 120
and the longitudinal member 62 of the GEFV restoration assembly 60
as a guide to a position preferably toward the patient's mouth from
the LES 48.
[0078] Invaginator member 146 is then moved in vivo from the first
configuration to the second configuration by application of air
pressure to the inflation member 147 for vacuum engagement of the
esophagus. Another step includes application of a vacuum to the
vacuum lumen 149 and correspondingly to the plurality of tissue
gripping vacuum orifices 144 in the longitudinal raised portions
143. In response to the applied vacuum, the plurality tissue
gripping vacuum orifices 144 draw in, and tightly and releasably
engage the esophageal wall with the invaginator member 146. A force
in the invagination movement direction 162 is applied to
invaginator extracorporeal movement control member 134 to push the
lower portion of esophagus 41 and the gastroesophageal junction 52
(not shown) toward and partially invaginated into the stomach 43.
This moves stomach tissue generally, and particularly a portion of
the fundus 46, into an improved position for restoration of the
GEFV. The invagination aids in creating the fold of tissue 115 by
partially pre-forming the fundus tissue, and by improving the
position and presentment of the fundus tissue to the mold 70. The
endoscopist is likely to need the invaginator device 130 to create
the fold of tissue 115 when a Grade IV GEFV is being restored. The
invaginator device 130 may not be needed when a Grade II or Grade
III GEFV is being restored. Once a restored GEFV 129 has been
formed, the invaginator member 146 is moved from the second
position to the third position for removal, and the invaginator
device 130 is removed from the patient.
[0079] The next three figures illustrate another gastroesophageal
flap valve restoration device according to another embodiment of
the invention. FIGS. 14 and 16 are perspective partial-sectional
views of a gastroesophageal flap valve restoration assembly 200
with a moveable tissue gripper, according to an embodiment of the
invention. FIG. 14 illustrates GEFV restoration assembly 200 with
the moveable tissue gripper 210 in its extended configuration. FIG.
15 is a cross-sectional plan view of the mold 230 of FIG. 14. FIG.
16 illustrates GEFV restoration assembly 200 with the moveable
tissue gripper 210 in its retracted/molding configuration. GEFV
restoration assembly 200 includes a longitudinal member 202, an
endoscopic channel 66, a non-invasive tissue gripper 210, a tissue
gripper control member 211, a vacuum port 139, a movable arm 212, a
plurality of tissue gripping orifices 214, a vacuum gripping
surface 216, a bending portion 218, a mold 230, a bending guide
surface 232, and a molding surface 234. FIGS. 14 and 16 do not
illustrate the extracorporeal portions of the endoscope 120 and the
longitudinal member 202, which are truncated for clarity.
[0080] Longitudinal member 202 is substantially similar to
longitudinal member 62 of GEFV restoration assembly 60 described in
conjunction with FIG. 3. The longitudinal member 202 carries the
mold 230 and the moveable arm 212 on its distal end for placement
within the stomach. For purposes of clarity, FIGS. 14 and 16 do not
illustrate the plurality of lumens 82a-e arranged to carry tissue
fixation devices 80 for deployment from the plurality of lumen
orifices 84a-e, and do not illustrate the extracorporeal movement
control member 64.
[0081] The tissue gripper 210 includes the tissue gripper control
member 211, the vacuum port 139, the moveable arm 212, the
plurality of tissue gripping vacuum orifices 214, the vacuum
gripping surface 216, and the bending portion 218. The tissue
gripper control member 211 is carried in a lumen (not shown) in
longitudinal member 202. The bending portion 218 joins the tissue
gripper control member 211 and the moveable arm 212, and is
arranged to bend over a range of about 90 degrees. The arm 212
carries vacuum gripping surface 216, which in turn carries the
plurality of tissue gripping vacuum orifices 214. The tissue
gripping vacuum orifices 214 are vacuum coupled to the vacuum port
139 by a vacuum lumen (not shown) running through the moveable arm
212, the bending portion 218, and the control member 211. In an
alternative embodiment, the vacuum coupling may include a vacuum
lumen that bypasses the bending portion 218. The plurality of
tissue gripping vacuum orifices 214 are arranged to grip tissue by
drawing in, and tightly and releasably engaging proximate tissue
with the vacuum gripping surface 216. Once engaged, the tissue
gripper 210 can be used to impart a force to the vacuum gripped
tissue to urge the gripped tissue and surrounding tissue in a
manner selected by the endoscopist.
[0082] The moveable arm 212 of the tissue gripper 210 is arranged
to be movable by moving control member 211 longitudinally relative
to the longitudinal member 202. FIG. 14 illustrates the tissue
gripper 210 with the moveable arm 212 in an extended configuration
for gripping tissue. FIG. 16 illustrates the moveable arm 212 of
the tissue gripper 210 in the retracted/molding configuration. The
moveable arm 212 is moved from the extended configuration of FIG.
14 to the retracted/molding configuration illustrated in FIG. 16 by
moving tissue gripper control member 211 distally and
longitudinally toward the mold 230. The movement of control member
211 distally forces the moveable arm 212 against bending guide
surface 232, which in turn exerts a bending force against bending
portion 218. Continued movement of control member 211 increases the
bend in the bending portion 218 and moves the moveable arm 212 to
the retracted/molding configuration. The bending guide surface 232
is arranged to control the position of the moveable arm 212
relative to the longitudinal member 202, so that the moveable arm
212 in the retracted/molding configuration holds the fold of tissue
115 proximate to the longitudinal member 202 and drawn into and
against the molding surface 234. The extension of moveable arm 212
is by moving the control member 211 proximally. The tissue gripper
210 is arranged to non-invasively grip and move a fold of tissue
115 into the mold 230. The tissue gripper 210 brings the tissues in
the fold of tissue 115 close together for fixation. In an
alternative embodiment, the molding configuration of the moveable
arm 212 includes moving the vacuum gripping surface 216 an
additional distance distally to a position where the vacuum
gripping surface 216 is distal of the bending guide surface 232. In
an alternative embodiment, the tissue gripper 210 can be arranged
to draw a fold of tissue 115 into the mold 70 of FIG. 3 by making
provision for and carrying the tissue gripper 210 with longitudinal
member 62.
[0083] FIG. 15 illustrates the mold 230 carried on the distal end
of the longitudinal member 202. Endoscope 120 and tissue gripper
210 are omitted from FIG. 15 for clarity. The mold 230 is a
semicircular structure that includes the bending guide surface 232
and the molding surface 234, and is arranged for causing stomach
tissue to assume a shape related to a gastroesophageal flap. The
molding surface 234 has an approximately 180 degree, semicircular
shape related to the normal gastroesophageal flap 50. In
alternative embodiments, the molding surface 234 may be configured
to form a semicircular structure having with a semicircular arc
varying between approximately 90 degrees and 360 degrees. The
molding surface 234 is arranged to have a fold of tissue 115 drawn
into it by the tissue gripper 210, thereby molding that fold of
tissue 115 into molded stomach tissue 125. The molding surface 234
is formed to replicate the normal gastroesophageal flap 50. In an
alternative embodiment, the mold 230 has a first collapsed
configuration for transoral placement into the stomach 43, and a
second configuration having a shape related to the gastroesophageal
flap.
[0084] FIGS. 17-22 are schematic cross-sectional views illustrating
the GEFV restoration assembly with tissue gripper 200 of FIGS.
14-16 being used to transorally restore a gastroesophageal flap
valve, according to an embodiment of the invention. The restoration
is similar to that described in conjunction with FIG. 10, and uses
the endoscope 120 for visualization and as a guide for placing the
distal end of the longitudinal member 202 in the stomach 43. FIG.
17 illustrates an initial step where the distal portion of the
longitudinal member 202 carrying the tissue gripper 210 and the
mold 230 is placed in the stomach 43. The moveable arm 212 is in a
first configuration for insertion, which is the retracted/molding
configuration.
[0085] FIG. 18 illustrates an intermediate step where the moveable
arm 212 is moved from the first retracted/molding configuration
position to the second gripping configuration for gripping and
moving a fold of tissue 115. The movement of the moveable arm 212
is by manipulation of the tissue gripper control member 211. Under
visualization of the endoscope 120, the moveable arm 212 is placed
in proximity to target tissue of the fundus 46 that is proximate to
the cardiac notch 47 and selected by the endoscopist as suitable
for restoration of the GEFV 49. A vacuum is applied to the tissue
gripping vacuum orifices 214, causing the vacuum gripping surface
216 to grip the target tissue by vacuum drawing in, and tightly and
releasably engaging the target tissue. The vacuum gripped target
tissue and tissue proximate to it form the fold of tissue 115.
[0086] FIG. 19 illustrates an intermediate step where the moveable
arm 212, while vacuum gripping the target tissue, is partially
moved from the second gripping configuration to the first
retracted/molding configuration and toward the mold 230. FIG. 20
illustrates another intermediate step where the moveable arm 212,
while vacuum gripping the target tissue, is moved further to the
first retracted/molding configuration and partially into the mold
230.
[0087] FIG. 21 illustrates still another intermediate step where
the moveable arm 212, while vacuum gripping the target tissue, has
been moved to the first retracted/molding configuration and fully
into the mold 230. Upon being moved fully into the mold 230 as
illustrated by FIG. 21, the molding surface 234 of mold 230 brings
the tissues comprising the fold of tissue 115 close together, and
causes the fold of tissue 115 to assume a shape related to a
gastroesophageal flap (molded stomach tissue 125). The fold of
tissue 115 does not include the gastroesophageal junction 52 or any
tissue oral of the gastroesophageal junction 52. To fixate and
secure the molded stomach tissue 125, at least one tissue fixation
device 80 is deployed from the lumen orifice 84 (not shown) in the
manner described in conjunction with FIGS. 5-9, and 10. The
fixation maintains the shaped stomach tissue in a shape
approximating a gastroesophageal flap (restored gastroesophageal
flap 127) as illustrated in FIG. 11. FIG. 22 illustrates a final
step where the mold 230 and moveable arm 212 are moved distally
into the stomach 43 for inspection by the endoscopist. A final step
includes removal of the mold 230 and the moveable arm 212 from the
patient.
[0088] FIG. 23 is a perspective partial-sectional view of a
gastroesophageal flap valve restoration assembly 250 with a tissue
gripper guide in its retracted/molding configuration, according to
an embodiment of the invention. The gastroesophageal flap valve
restoration assembly 250 is similar in construction and operation
to the flap valve restoration assembly 200. The restoration
assembly 250 includes a guide support 254 and a guide surface 256,
but does not include the mold 230 of FIG. 14. The restoration
assembly 250 uses the tissue gripper 210 as a tissue shaper to
cause stomach tissue to assume a shape related to a
gastroesophageal flap 50. Guide support 254 is carried on
longitudinal member 202, and the guide surface 256 is arranged to
control the position of the moveable arm 212 relative to the
longitudinal member 202, so that the moveable arm 212 in the
retracted/molding configuration holds the fold of tissue 115
proximate to the longitudinal member 202.
[0089] FIG. 24 is a cross-sectional view illustrating the
gastroesophageal flap valve restoration assembly 250 of FIG. 23
being used to transorally restore a gastroesophageal flap valve,
according to an embodiment of the invention. Restoration of the
gastroesophageal flap with the gastroesophageal flap valve
restoration assembly 250 is similar to the restoration of the
gastroesophageal flap with the flap valve restoration assembly 200
described in conjunction with FIGS. 17-22. The restoration begins
to differ at FIG. 21, the point where the moveable arm 212 is in
the retracted/molding configuration and is holding the fold of
tissue 115 proximate to the longitudinal member 202 in an initial
shaping position 258. As illustrated in FIG. 24, the longitudinal
member 202 and the movable arm 212 become the tissue shaper of this
embodiment, and cause the gripped stomach tissue to assume a shape
related to a gastroesophageal flap. A plurality of tissue gripping
steps is used to cause the fold of tissue 115 to assume a shape
related to a gastroesophageal flap. To this end, the movable arm
212 preferably has a length greater than 2 cm, as for example,
between 4 and 5 cm as previously discussed to create a flap of a
corresponding length, although greater lengths may also be
employed. At least one tissue fixation device 80 is deployed into
the fold of tissue 115 at the initial shaping position 258. The
vacuum applied to the plurality of tissue gripping vacuum orifices
214 is reduced to disengage the vacuum gripping surface 216 from
the fold of tissue 115, and the moveable arm 212 may be moved away
from the fold of tissue 115. The longitudinal member 202, which
carries the tissue gripper 210 and the guide support 254, is
rotated to another shaping position 259. The vacuum is reapplied to
the plurality tissue gripping vacuum orifices 214 to engage the
vacuum gripping surface 216 with the fold of tissue 115, and the
movable arm 212 is moved to retracted/molding configuration. At
least one tissue fixation device 80 is deployed into the fold of
tissue 115 at the another shaping position 259. The movement,
shaping, and fixation of tissue in a shape approximating a
gastroesophageal flap continues until a restored gastroesophageal
flap 127 is formed. The restoration is viewed from a retroflexed
endoscope, and the endoscopist is able to inspect each step. Once
the endoscopist is satisfied that a restored GEFV 49 has been
formed, as illustrated in FIG. 11, a final step includes removal of
the gastroesophageal flap valve restoration assembly 250 from the
patient.
[0090] FIG. 25 is perspective partial-sectional view of a
gastroesophageal flap valve restoration assembly of FIGS. 14-16
arranged to engage an extracorporeal portion of an endoscopic
device when a portion of the endoscopic device is in vivo,
according to an embodiment of the invention. FIG. 26 is a
perspective partial cross-sectional view of gastroesophageal flap
valve restoration assembly 300. Gastroesophageal flap valve
restoration assembly 300 includes a longitudinal member 302, which
includes a retention portion 304, and in an alternative embodiment
at least one other retention portion 306.
[0091] The endoscopic channel 66 of longitudinal member 302 is
round but does not close along its length, allowing the restoration
assembly 300 to be removably engaged with a portion of the shaft of
an endoscopic device 120 when the retroflexed end 122 is in vivo.
The endoscopic channel 66 of longitudinal member 302 is dimensioned
to partially surround a length or a portion of a shaft of an
endoscopic device 120. The retention portions 304 and 306 are
arranged to allow longitudinal member 302 to engage the shaft of an
endoscopic device 120, to retain the engagement until disengaged by
the endoscopist, and to allow the longitudinal member 302 to be
moveable relative to the shaft of the engaged endoscope 120. In an
alternative embodiment, the gastroesophageal flap valve restoration
assembly 300 includes a plurality of longitudinal shims to match
the diameter of the endoscopic channel 66 to the diameter of the
endoscope shaft.
[0092] The ability to engage the longitudinal member 302 of
gastroesophageal flap valve restoration assembly 300 with the shaft
of an endoscope 120 allows an endoscopist to first endoscopically
view the stomach 43 and GEFV 49 to determine whether restoration is
indicated. When restoration is indicated, the endoscopist can then
engage the longitudinal member 302 with the shaft of the endoscope
120 without removing the retroflexed tip (distal end) of the
endoscope 122 from the stomach 43. The gastroesophageal flap valve
restoration assembly 300 is then moved down the shaft of the
endoscope 120 and into position for restoration of the
gastroesophageal flap.
[0093] The arrangement providing an ability to engage a
longitudinal member of a gastroesophageal flap valve restoration
assembly with an endoscope without removing the retroflexed tip of
the endoscope from the stomach may be used for any of the devices
described herein. Extracorporeal movement control members, such as
member 64 of FIG. 3, may require an opening to allow the shaft of
the endoscope 120 to fully enter the endoscopic channel 66.
[0094] Referring now to FIGS. 27-31, FIG. 27 shows the movable arm
212 in an initial position to permit the tissue gripper 210 to
reach upward and outward for gripping the fundus 46. This "reaching
out" for the fundus 46, as will be seen subsequently, results in
the restored GEFV being completely aboral of the Z line 52.
[0095] FIG. 28 shows the tissue gripper 210 engaging the fundus 46.
The movable arm 212, to enable the "reaching out" has a length
dimension of, for example, 3 to 6 cms, and preferably 4 to 5 cms to
in turn result in a restored GEFV flap having a length greater than
2 cms as shown, for example, in FIG. 11. The vacuum engaging
surface 216 is fully engaged with the fundus 46 into the tissue
shaper formed by the movable arm 212 and the control member
211.
[0096] FIG. 29 shows the fundus 46 initially being drawn into the
shaper formed by the arm 212 and the member 211. This initial
movement is occasioned by the downward movement of the member 211
causing arm 212 to engage molding surface 234 of the mold 230.
[0097] FIG. 30 shows that, as member 211 continues to move
downwardly, the fundus 46 continues to be pulled into the shaper
formed by member 211 and arm 212. It may also be noted that the
nearly restored GEFV flap is complete aboral of the Z line 52. This
is made possible by the "reaching out" of the tissue gripper 210 as
previously mentioned. The mold 230 also continues to cause the
tissue shaper of member 211 and arm 212 to close on the fundus as
arm 212 pivots about the bending portion 218.
[0098] FIG. 31 shows the restored GEFV flap prior to the shaped
fundus being fastened for maintaining the configuration thereof. As
will be noted, the restored GEFV flap configuration is defined by
the shaper of member 211 and arm 212 as well as the fundus contact
with molding surface 234 of the mold 230. It will also be noted
that the GEFV flap thus formed is entirely aboral of the Z line 52.
Hence, the tissue interface 57 is completely a serosa to serosa
fundus tissue interface.
[0099] As in previous embodiments, a portion of the device 200 may
be transparent or substantially transparent to enable better
visualization, as for example, of the Z line, during the procedure.
To that end, the longitudinal member 202 and/or the member 211 and
arm 212 may be formed of a transparent material.
[0100] Although the present invention has been described in
considerable detail with reference to certain preferred
embodiments, other embodiments are possible. Therefore, the spirit
or scope of the appended claims should not be limited to the
description of the embodiments contained herein. It is intended
that the invention resides in the claims hereinafter appended.
* * * * *