Note: Descriptions are shown in the official language in which they were submitted.
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A METHOD OF IMPLANTING A MEDICAL DEVICE USING
A SUTURE TAB EXTENDER
[0001] CROSS REFERENCE TO RELATED APPLICATIONS
[0002] This application is a continuation in part of U.S. Patent
Application Serial No.
11/182,072, entitled "LATCHING DEVICE FOR GASTRIC BAND", filed July 15,
2005, which is currently pending. This application is a continuation in part
of U.S. Patent
Application Serial No. 11/364,362 entitled "GASTRIC BAND", filed March 1,
2006,
which is a continuation in part of U.S. Patent Application Serial No.
11/364,361 entitled"
GASTRIC BAND SUTURE TAB EXTENDER", Filed on March 1, 2006, which is a
continuation in part of U.S. Patent Application Serial No. 11/364,363 entitled
" Precurved
Gastric Band", filed on March 1, 2006.
[0003] BACKGROUND OF THE INVENTION
[0004] Field of the Invention
[0005] The invention relates to a gastric band and related accessories.
[0006] Description of the Prior Art
[0007] Morbid obesity is a serious medical condition. In fact, morbid
obesity has become highly
pervasive in the United States, as well as other countries, and the trend
appears to be
heading in a negative direction. Complications associated with morbid obesity
include
hypertension, diabetes, coronary artery disease, stroke, congestive heart
failure, multiple
orthopedic problems and pulmonary insufficiency with markedly decreased life
expectancy. With this in mind, and as those skilled in the art will certainly
appreciate,
the monetary and physical costs associated with morbid obesity are
substantial. In fact, it
is estimated the costs relating to obesity are in excess of one hundred
billion dollars in the
United States alone.
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[0008] A variety of surgical procedures have been developed to treat
obesity. The most common
currently performed procedure is Roux-en-Y gastric bypass (RYGB). This
procedure is
highly complex and is commonly utilized to treat people exhibiting morbid
obesity.
Other forms of bariatric surgery include Fobi pouch, bilio-pancreatic
diversion, and
gastroplastic or "stomach stapling". In addition, implantable devices are
known which
limit the passage of food through the stomach and affect satiety.
[0009] In view of the highly invasive nature of many of these procedures,
efforts have been
made to develop less traumatic and less invasive procedures. Gastric-banding
is one of
these methods. Gastric-banding is a type of gastric reduction surgery
attempting to limit
food intake by reducing the size of the stomach. In contrast to RYGB and other
stomach
reduction procedures, gastric-banding does not require the alteration of the
anatomy of
the digestive tract in the duodenum or jejunum.
[0010] Since the early 1980's, gastric bands have provided an effective
alternative to gastric
bypass and other irreversible surgical weight loss treatments for the morbidly
obese.
Several alternate procedures are performed under the heading of gastric-
banding. Some
banding techniques employ a gastric ring, others use a band, some use stomach
staples
and still other procedures use a combination of rings, bands and staples.
Among the
procedures most commonly performed are vertical banded gastroplasty (VBG),
silastic
ring gastroplasty (SRG) and adjustable silastic gastric banding (AGB).
[0011] In general, the gastric band is wrapped around an upper portion of
the patient's stomach,
forming a stoma that is less than the normal interior diameter of the stomach.
This
restricts food passing from an upper portion to a lower digestive portion of
the stomach.
When the stoma is of an appropriate size, food held in the upper portion of
the stomach
provides a feeling of fullness that discourages over eating.
[0012] More particularly, and in practice, the gastric band is inserted
behind the stomach and the
ends of the gastric band are coupled to latch the device about the stomach.
However, it is
often difficult to maneuver the ends of the gastric band for proper latching.
As such,
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mechanisms for enhancing the application of gastric bands about a stomach are
needed.
The present invention provides such a mechanism in the form of an extension
device for
utilization in conjunction with currently available gastric bands, which is
removable after
the gastric band is properly installed. The present invention also provides an
improved
gastric band construction facilitating ease of application about a stomach and
enhanced
functionality once applied.
[0013] SUMMARY OF THE INVENTION
[0014] &
[0015]
In one embodiment, there is provided a use of a surgically implantable band
for
implantation around an anatomical structure in a patient, said surgically
implantable band
comprising: an elongated body member including a first end having a first
latching
member positioned thereon, and a second end having a second latching member
positioned thereon, said first latching member having a suture tab extender
extending
therefrom, said suture tab extender having a suture attached thereto, said
second end
having a gripping section positioned thereon shaped and dimensioned to
facilitate
gripping thereof as the suture tab extender is passed through the second
latching member;
wherein said suture tab extender is removable from said band
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[0016] BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Figure 1 is a perspective view of the suture tab extender secured to
a gastric band.
[0018] Figure 2 is a perspective view of the removable suture tab extender.
[0019] Figure 3 is a perspective view of the gastric band secured about the
stomach.
[0020] Figure 4, 5 and 5a are various perspective views of a gastric band
in accordance with the
present invention.
[0021] Figures 6, 7 and 8 show the various steps in the attachment of the
gastric band using the
present suture tab extender.
[0022] Figure 9 is a perspective view of a suture tab extender in
accordance with a further
embodiment.
[0023] Figure 10 is a perspective view of a suture tab extender in
accordance with an alternate
embodiment.
[0024] Figures 11, 12, 13 and 14 respectively show a perspective view of a
balloon, a
perspective view of a belt, a cross sectional view of a gastric band and a
perspective view
of the gastric band in accordance with another embodiment of the present
invention.
[0025] Figures 15 and 16 respectively show a perspective view of a gastric
band and a cross
sectional view of the gastric band in accordance with an alternate embodiment
of the
present invention.
[0026] Figure 17 is a cross sectional view of a gastric band in accordance
with another
embodiment of the present invention.
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[0027] Figures 18, 19, 20 and 21 respectively show a perspective view of a
belt, a perspective
view of a balloon, a cross sectional view of a gastric band and a perspective
view of the
gastric band in accordance with yet another embodiment of the present
invention.
[0028] Figures 22 to 31 show various embodiments of a balloon type gastric
band with differing
supply tube locations.
[0029] Figures 32 to 43 show various embodiments of suture tab extenders
with differing
attachment structures.
[0030] DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0031] The detailed embodiments of the present invention are disclosed
herein. It should be
understood, however, that the disclosed embodiments are merely exemplary of
the
invention, which may be embodied in various forms. Therefore, the details
disclosed
herein are not to be interpreted as limiting, but merely as the basis for the
claims and for
teaching one skilled in the art how to make and/or use the invention.
[0032] With reference to Figures 1 and 2, a removable suture tab extender
100 for use in
conjunction with a gastric band 10 is disclosed. The extender 100 is designed
to enhance
usage of gastric bands 10 and aid with the use of the gastric band latching
mechanism 20.
In particular, the extender 100 provides a mechanism for assisting in the
passage of the
first latching member 22 of the latching mechanism 20 through the second
latching
member 26 of the latching mechanism 20 by either threading or pushing the
first latching
member 22 through the second latching member 26 or by inserting a grasper
through the
second latching member 26, grasping the tip of the extender 112, and pulling
it back
through the second latching member 26 to lock.
[0033] To attach the extender 100 to the gastric band 10, the tether strap
108 of the extender 100
is threaded through an aperture 38 in the tip of the latching mechanism 20.
This tether
strap 108 is then glued to the rest of the extender 100 inside a coupling
indent 110. In
accordance with an alternate embodiment, and with reference to Figure 10, the
extender
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300 may be provided with a pocket 311 positioned at the end of the coupling
indent 310
in which the tether strap 308 may be glued.
[0034] The extender 100 is easily removed or cut apart from the gastric
band 10 once the gastric
band 10 is properly positioned and secured about the stomach, thereby
minimizing the
risk of "sharp" band edges if the band itself was cut. To remove the extender
100, the
tether strap 108 is cut between the aperture 38 in the tip 36 of the gastric
band 20 and the
coupling indent 110 containing the glued tether strap 108. This allows the
extender 100
to be removed in one piece, leaving the gastric band 100 completely intact
without any
"sharp" band edges.
[0035] The extender 100 may further be provided with a recess 109 (see
Figure 2) on the
extender 100 for inserting scissors between the tip 36 of the gastric band 20
and the tether
strap 108 to better facilitate cutting off the extender 100. The extender 100
is completely
removed from the body after it has been cut off of the gastric band 10. The
extender 100
also allows for the creation of an interim lock permitting adjustment around
the stomach
before final locking of the latching mechanism 20. Although a preferred
embodiment has
the extender cut off for one piece removal from the gastric band body, an
alternate
embodiment would entail leaving the extender in place on the gastric band and
utilizing
the interim lock (that is, the retention member 114, 214 that is described
below in greater
detail) as an additional permanent locking position for use with varying
stomach sizes.
[0036] In practice, and with reference to Figure 3, the present suture tab
extender 100 is secured
to the first end 14 of the gastric band 10 adjacent the first latching member
22 to form a
single band/extender functional unit. Thereafter, the gastric band 10, with
the extender
100 secured thereto, is inserted behind the stomach. The first latching member
22 of the
latching mechanism 20, as well as the extender 100, are then pushed or pulled
through
the second latching member 26 of the latching mechanism 20. The addition of
the
present suture tab extender 100 provides a longer region for grasping and
manipulation of
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the first latching member 22 as it is passed about the stomach and through the
second
latching member 26.
[0037] In accordance with a preferred embodiment, and as will be discussed
below in greater
detail, the suture tab extender 100 is an elongated, elastomeric component
that attaches to
the first end 14 of the gastric band 10 to assist in mating and locking the
first latching
member 22 with the second latching member 26. The extender 100 is preferably
attached
to a tab 24 at the first end 14 of the gastric band 10 to hold the extender
100 in place.
The extender 100 is removable with one cut through the tether strap 108 on the
extender
100 and incorporates a recess or an open recess, for example, a cuplike
feature, 106 for
coupling the first end 14 of gastric band 10 and extender 100 close together
so as to move
as an integral unit.
[0038] More specifically, and as will be greater appreciated based upon the
following disclosure,
the tab 24 of the gastric band 10 is positioned within the recess 106 of the
extender 100
and is safely and securely coupled thereto using a tether strap 108. In
addition, and in
accordance with the preferred embodiment, the second end of the extender may
include a
suture loop 105 for compatibility with a Goldfinger-like device 150. As those
skilled in
the art will certainly appreciate, the Goldfinger-like device 150 assists in
passing the
gastric band 20 through the retro-gastric tunnel. Alternately, for surgeons
who use other
devices for passing the gastric band 20 through the retro-gastric tunnel, the
gripping
section, or flat tip, 112 of the extender 100 is compatible with these band-
passing devices
as well. In general a Goldfinger instrument is an articulating band passing
device used to
perform blunt dissection behind the stomach before passing the gastric band.
It is
articulated and fed behind the stomach. In the tip of the Goldfinger
instrument there is a
notch that a suture loop can catch on. Once the suture is caught, the
Goldfinger
instrument is pulled out of the retro-gastric tunnel and the suture loop pulls
the band with
it. Alternately, to facilitate use with these other band passing-devices, a
length of the
extender may be round (like tubing) behind the flat tip so that the extender
is easier to
orient.
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[0039] The removable extender 100 is designed for use with a variety of
gastric bands. By way
of example, the extender is designed for use with gastric bands as disclosed
in commonly
owned U.S. Patent Application Serial No. 11/182,072, filed July 15, 2005,
entitled
"LATCHING DEVICE FOR GASTRIC BAND".
[0040] In general, and with reference to Figures 4, 5 and 5a, the gastric
band 10 includes a band
body 12 having a first end 14 and a second opposite end 16. The band body 12
and
latching mechanism 20 are preferably manufactured from silicone. Although, and
as will
be discussed below in greater detail, the gastric band is a balloon type
gastric band, the
present latching mechanism may be used in conjunction with a variety of band
structures
without departing from the spirit of the present invention.
[0041] As briefly mentioned above, the gastric band 10 is shaped and
dimensioned to
circumscribe the stomach at a predetermined location reducing the size of the
stomach.
The gastric band 10 employs a flexible latching mechanism 20 capable of
locking and
unlocking without destruction of the latching mechanism 20 or significant
reduction in
retention capabilities after re-locking. The first and second ends 14, 16
respectively act
as both male and female members depending on the direction of motion and
intent to lock
or unlock the latching mechanism 20 of the present gastric band 10.
[0042] The first end 14 includes a shell member, or first latching member,
22 generally
composed of a hollow, half-moon shaped shell with a tab 24 for gripping and
pulling
through a collar member, or second latching member, 26 composed of a semi-
circular
shaped aperture 30 on the second end 16. The half-moon shell of the first
latching
member 22 collapses as it is pulled or pushed through the collar member 26 by
a grasper.
The collar member 26 includes a tongue 28 such that the shell member 22 slides
through
the semi-circular shaped aperture 30 and under the tongue 28 during latching.
Once the
shell member 22 passes the tongue 28, the roles change. The first end 14
functions as a
female component when the shell member 22 resiliently returns to its original
shape and
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is allowed to slide back onto the second end 16 (now a male component) and
over the
tongue 28. As such, the shell member 22 functions as both a male component and
female
component during operation of the latching mechanism 20 and the collar member
26
functions as both a male component and female component during operation of
the
latching mechanism 20; that is, the shell member 22 functions as a male
component
during insertion through the collar member 26 and a female component
thereafter when
the tongue 28 is seated therein.
[0043] Unlocking is achieved by employing graspers to pull the first end 14
forward away from
the second end 16 removing the tongue from the shell member 22. The M-shape of
the
shell member 22 permits it to collapse and move under the tongue 28 and
through the
collar member 26.
[0044] More particularly, the shell member 22 at the first end 14 of the
gastric band 10 is
generally a half-moon shaped shell with an open, wide end 32 tapering toward a
narrow
end 34 adjacent the tip 36 of the first end 14. The shell member 22 is
substantially
hollow and is formed from a material, for example, silicone, which permits
compression
and expansion thereof.
[0045] Referring to Figure 5a, the shell member 22 is formed with a
substantially M-shaped
outer surface 23a when viewed from the wide end 32 thereof. That is, the outer
surface
of the shell member 22 has a substantially M-shaped profile, while the inner
surface 23b
of the shell member 22 adjacent the wide end 32 has a substantially smooth
semi-circular
profile. The single M-shaped profile has been found to improve flexibility and
control as
the shell member 22 is passed through the collar member 26. In addition, the
inclusion of
the M-shape in the wide end 32 of the shell member 22 permits ease of
unlocking, as it
will be easier and more controllable for one to compress the shell member 22.
[0046] The shell member 22 is slid through the collar member 26 as
discussed above.
Thereafter, the center 54 of the M-shaped wide end 32 returns to its original
shape and
fits over the tongue 28. When the gastric band 10 is unlatched, the shell
member 22 is
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pulled forward away from the collar member 26 and the M-shaped shell member 22
permits it to move under the tongue 28 and through the collar member 26. The
preformed shape of the shell member 22 not only acts as a guiding feature for
the tongue
28 to slide over the shell member 22 during unlocking, but will also allow the
shell
member 22 to more easily slide back through the aperture 30 of the collar
member 26.
[0047] An aperture 38 is formed within the tab 24 adjacent the tip 36 of
the first end 14 and the
narrow end 34 of the shell member 22. The aperture 38 is shaped and
dimensioned for
receipt of a suture or grasper commonly used in the installation of gastric
bands. In
addition, the tab 24 is formed with protrusions 39 assisting in grabbing the
tab 24 during
locking and unlocking.
[0048] Also at the first end 14, but on the opposite side of the shell
member 22 from the aperture
38 and adjacent the wide end 32 of the shell member 22 is a rearwardly
extending
gripping member 51. The gripping member 51 is shaped and dimensioned to permit
dual
directional access for locking and unlocking of the latching mechanism 20.
More
particularly, the gripping member 51 includes protrusions 56 along the top and
bottom
surfaces 53, 55 thereof. These protrusions facilitate gripping thereof along a
first
directional orientation. The gripping member 51 is further formed with an
"hour glass"
shape having a reinforced central section 57. The reinforced central section
57 allows for
gripping in a second directional orientation.
[0049] Secure fastening of the shell member 22 with the collar member 26 is
achieved by
ensuring that after the shell member 22 compresses while passing through the
collar
member 26, the shell member 22 returns to its original shape and the wide end
32 of the
shell member 22 abuts with the first edge 46 of the collar member 26.
[0050] Latching is further enhanced by providing the collar member 26 with
a tongue 28
extending from the collar member 26 away from the tip 50 of the second end 16.
The
tongue 28 is shaped and dimensioned to seat within the wide end 32 of the
shell member
22 after the shell member 22 has passed through the collar member 26 and the
gastric
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band 10 is tensioned as the first and second ends 14, 16 are drawn toward each
other with
the shell member 22 straining to move back through the collar member 26 toward
an
unlatched positioned. With this in mind, the tongue 28 may be downwardly
oriented
such that it slides with the shell member 22 in a convenient and reliable
manner. The
tongue 28 may be distinctly colored to provided an indication as to whether
the latching
mechanism 20 is properly locked.
[0051] Gripping of the second end 16 is further enhanced through the
provision of a forward
facing gripping member 58, that is, a gripping member facing the tip 50 of the
second end
16. The forward facing gripping member 58 is shaped and dimensioned to permit
dual
directional access for locking and unlocking of the latching mechanism 20.
More
particularly, the gripping member 58 includes protrusions 59 along the top and
bottom
surfaces 62, 64 thereof These protrusions 59 facilitate gripping thereof along
a first
directional orientation. The gripping member 58 is further formed with an
"hour glass"
shape having a reinforced central section 60. The reinforced central section
60 allows for
gripping in a second directional orientation.
[0052] The gripping member 58 is shaped and dimensioned to receive and
center the shell
member 22 as it passes through the collar member 26. The gripping member 58
also
assists in compressing the shell member 22 as it passes through the collar
member 26.
[0053] In accordance with a preferred embodiment of the present invention,
the gastric band is a
balloon-type gastric band as shown in Figures 11 to 16. With this in mind, the
gastric
band 410 is generally composed of a reinforcing belt 412 to which an elongated
balloon
414 is secured. The belt 412 includes a first end 416 and a second end 418 to
which the
first and second latching members 422, 426 are respectively secured. The belt
412
further includes an inner surface 428 and an outer surface 430. The outer
surface 430 is
substantially smooth and forms a substantial portion of the outer surface 431
of the
gastric band 410 when it is secured about a patient's stomach. The inner
surface 428 of
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the belt 412 is shaped and dimensioned for attachment to the outer surface 438
of the
balloon 414.
[0054] With regard to the balloon 414, it also includes a first end 432, a
second end 434, an inner
surface 436 and an outer surface 438. The inner surface 436 is substantially
smooth and
is shaped and dimensioned for engaging the patient's stomach when the gastric
band 410
is secured thereto. The outer surface 438 of the balloon 414 is shaped and
dimensioned
for coupling with the inner surface 428 of the belt 412.
[0055] Referring to Figures 11 to 16, the belt 412 and balloon 414 may be
respectively coupled
by either overmolding or separate molding with subsequent adhesive bonding
(similar
numerals are used for the different embodiments). Regardless of the
manufacturing
technique, the outer surface 438 of the balloon 414 is formed with a groove
439 shaped
and dimensioned for receiving the belt 412. Referring to Figures 15 and 16,
wherein the
belt 412 is adhesively bound to the balloon 414, the groove 439 is formed with
a glue gap
439a shaped and dimensioned for receipt of a small amount of adhesive without
adversely affecting the position of the belt 412 within the groove 439.
[0056] In accordance with an alternate embodiment, and with reference to
Figure 17, it is
contemplated the balloon 414' and the belt 412' may be coupled by adding a
layer of
uncured material 413' (similar in composition to components) between the
balloon 414'
and belt 412', and curing them together. In addition, a layer of reinforcing
structure 415'
(mesh, dissimilar material, or higher durometer silicone material) is
contained within the
layer of uncured material 413'. This reinforcing structure 415' is
encapsulated within the
device upon assembly and curing, and provide additional structure or different
mechanical properties to the product.
[0057] In addition, and with reference to Figures 18 to 21, yet a further
gastric band 410"
construction is contemplated in accordance with the present invention. In
accordance
with this embodiment, the belt 412" is secured along an internal surface 417"
of the
balloon 414", with the outer surface 428" of the balloon 414" forming the
exposed
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outer surface 430" of the gastric band 410". As with the embodiments disclosed
above,
the internal surface 417" is formed with a groove 439" shaped and dimensioned
for
receiving the belt 412". Secure positioning of the belt 412" within the groove
439" is
achieved through provision of a glue gap 439a" along the groove 439" and a
retaining
snap 439h" along the length of the groove 439". The glue gap 439a" is
substantially
similar to that employed in accordance with the embodiment disclosed with
reference to
Figures 16 and 17.
[0058] As to the retaining snap 439b", the groove 439" is constructed with
opposed, inwardly
directed protrusions 439c" shaped and dimensioned to engage the belt 412", and
temporarily retain the belt 412" within the groove 439", while the glue used
to couple
the belt 412" and balloon 414" cures during the gluing operation. More
particularly, the
inwardly directed protrusions 439c" are shaped and dimensioned to wrap about
the belt
412" in a manner holding it within the groove 439c".
[0059] In accordance with a preferred embodiment, the belt 412" is
positioned within the
balloon 414" in the following manner. The belt 412" is threaded through one of
the
balloon openings 433", 435" on either end 432", 434" of the balloon 414". The
retaining snap 439b, specifically protrusions 439c", on the groove 439 of the
balloon
414" temporarily hold the components together while they are being glued via a
long
needle inserted between the balloon 414" and the belt 412". Alternately, it is
contemplated the balloon can be overmolded onto the belt.
[0060] In accordance with preferred embodiments, and as briefly discussed
above, the balloon
and belt may be secured together by either adhesive bonding, comolding,
overmolding or
mechanical connection (for example, coupling sleeves), which secures the
balloon and
belt in a manner resulting in the coupling of these distinct gastric band
components.
Where the belt and balloon are overmolded, a plug 415 would be used to close
the core
outlet in the balloon for the over mold and the plug would be integral to the
gastric band
structure (see Figure 14). As those skilled in the art will certainly
appreciate, co-molding
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is essentially the same procedure as overmolding, but materials of different
properties are
shot in the mold at the same time. As with overmolding, comolding requires a
plug to
close the core outlet in the balloon.
[0061] Regardless of how the product is molded or assembled together, the
belt and balloon
components may consist of the same materials or different materials (material
durometer,
fillers such as BaSO4, Ti02, colorants, etc.). In addition, features within
the same
component (i.e. the locking features or end caps) may vary in composition.
These
features may be adhered to the rest of the product with adhesive, mechanical
fastening
(i.e., snap fits), welding, co-molding, or overmolding. Although the belt is
disclosed as
being secured to an outer surface of the balloon, it is contemplated the belt
may be
internal or external to the balloon surface or integrated into the balloon,
without departing
from the spirit of the present invention.
[0062] For assembly methods allowing the adherence of different components
(that is, adhesive
bonding, mechanical connection, oveanolding), unique belt and balloon
components may
be combined to provide variable configurations. For example, belts with
different
locking mechanisms may be interchanged with balloons of different lengths to
provide
the possibility of multiple combinations of products.
[0063] The balloon 414 is constructed to enhance contact with the stomach
wall when applied
thereto. With this in mind, and as will be discussed below in greater detail,
the balloon
414 is constructed as a precurved, low pressure, high volume balloon. The
balloon 414 is
constructed to maintain a soft and flexible surface (low pressure) when
applied to the
stomach tissue. The balloon 414 is also constructed to provide 360 degree
coverage to
prevent tissue pinching or discontinuities in stomach shape, and, as such, may
employ the
balloon construction disclosed in commonly owned U.S. Patent Application
Serial No.
11/182,070, entitled "GASTRIC BAND WITH MATING END PROFILES", filed
07/15/2005. The balloon 414 is further constructed such that it
reaches it fully
inflated and encircling configuration with minimal
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"folds". In addition, the balloon 414 is constructed to exhibit no folds or
creases (single
axis, not dual axis) when all fluid is evacuated therefrom.
[0064] With the foregoing in mind, the balloon 414 employed in accordance
with a preferred
embodiment of the present application is constructed of an elastomeric
material. Due to
the design of this balloon, it does not inflate or expand in a manner causing
high strain in
balloon when filled during gastric band adjustment. Rather, the balloon 414 is
adapted to
receive a large volume of fluid under a relatively low pressure. In this way,
the balloon
414 receives fluid during application, but does not inflate or expand in a
traditional
manner creating strain along the walls of the balloon 414. In other words,
when the
balloon 414 is filled up to the volume recommended to achieve maximum stomach
restriction, there is no expansion of the balloon material. Instead, the
balloon 414 fills to
some percentage of its total theoretical volume (that is, maximum fill
volume). Since the
balloon 414 is not filled even close to its maximum fill volume, it remains
low pressure,
allowing the balloon 414 to conform to the stomach rather than the stomach to
a rigid
balloon.
[0065] In accordance with a preferred embodiment of the present invention,
the balloon 414 is
designed with a maximum capacity of between approximately 10 cc and
approximately
18 cc, and preferably 18 cc, although it will be fully filled for functioning
in accordance
with the present invention to achieve the smallest stoma size with
approximately 9 cc to
approximately 12 cc, and preferably 9 cc. By providing a balloon 414, which is
not at its
capacity when properly filled for functioning, the softness and conformance of
the
balloon is improved. While specific volumes are disclosed in accordance with a
preferred embodiment of the present invention, those skilled in the art will
appreciate the
filling volumes may be varied,.
[0066] In addition, the balloon 414 is fabricated such that it exhibits a
curved configuration
when unstressed. Although a variety of curvatures are possible within the
spirit of the
present invention, the curved configuration is designed to offer a radius of
curvature of
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approximately 0.5 inches to approximately 1.5 inches. In addition, it is
contemplated the
balloon may have a varying radius as it extends about its length. In general,
the balloon
curvature is designed to approximate the curvature required to bring the first
and second
latching members 422, 426 into approximation or contact when the balloon 414
is
unbiased and left to assume a relaxed configuration. By fabricating the
balloon 414 with
an inherent curvature, folds created upon the application of fluid are
substantially
decreased. With this in mind, the belt is similarly pre-curved to reduce folds
and
approximate the first and second latching members 422, 426.
[0067] As those skilled in the art will certainly appreciate, the belt 412
is constructed to have a
curvature approximately the same that of the balloon 414 such that undesirable
tension
between the belt 412 and balloon 414 is reduced. In addition, and in
consideration of the
precurved nature of the belt 412, the belt 412 readily conforms to the outer
surface of the
stomach and the belt 412.
[0068] Contact with the stomach tissue is further enhanced by providing the
balloon 414 with a
concave cross-section along the balloons inner surface 436. This cross
sectional
configuration helps to facilitate evacuation and straightening thereof.
[0069] By implementing the structural criteria outlined above, the balloon
414 deflates with no
creases or bulges forming on the inner surface 436 of the balloon 414, a low
pressure and
pre-curved balloon 414 is achieved and the balloon 414 changes shape when it
is filling
(zip-lock bag filling up). As to the change in shape, the balloon 414 is
constructed such
that it has a relatively wider and flatter cross section prior to filling
along a cross section
transverse to the longitudinal axis of the balloon 414. When the balloon 414
is
subsequently filled during application to the stomach of a patient, the
transverse cross
sectional shape of the balloon 414 changes to that of a rounder balloon
exhibiting a
narrower cross section with a greater distance between the inner and outer
surfaces 436,
430 thereof With this in mind, it is further contemplated that the balloon
cross section
may be molded in a rounded rectangular shape, wherein the "corners" provide
support,
CA 02593910 2007-07-18
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distribute the change in shape and reduce folds. By providing a balloon which
is wide
and flat prior to filling, the distance between the inner surface of the
balloon and the belt
is reduced. This reduces the ultimate profile of the gastric band and improves
the ability
of the gastric band to be readily delivered for deployment.
[0070] As those skilled in the art will certainly appreciate, a supply tube
is used to connect the
internal cavity of the balloon of the gastric band with a pressurized fluid
source. The
utilization of the tube with a remote fluid source allows for controlled
inflation and
deflation of the balloon in a predetermined manner. The exact position of the
tube is
important in that the surgeon does not want tubing to be a visual obstruction
during
locking and/or other manipulation of the gastric band. In addition, once
placement of the
gastric band is complete, the tube should not cause irritation to surrounding
tissue (for
example, sticking directly into the liver or spleen). Surgeons also do not
want to pull the
tube through a retro-gastric tunnel, since they cannot easily see if the
tissue is being
damaged. The tube should also be able to act as a safe grasping location for
manipulation
of the gastric band, the tube must not kink at the junction to the gastric
band and prevent
fluid flow, and the tube location should facilitate passage of the band
through a small
trocar.
100711 With this in mind, and in accordance with various preferred
embodiments of the present
invention, different tube placements are shown with reference to Figures 22 to
31. As
each these various embodiments show, the tube is positioned at an end of the
gastric
band. By positioning the tube at an end of the gastric band it has been found
that forces
upon the tube, gastric band, and, ultimately the stomach, are reduced. This
positioning
also enhances the ability of the tube and gastric band to flex for insertion
and expand to
its original shape upon deployment.
[0072] Referring to Figure 22, the tube 540 is oriented to exit the gastric
band 510 from the outer
surface thereof. In accordance with a preferred embodiment of this design, the
tube 540
is positioned such that is comes out the outer surface 531 of the gastric band
510 just
CA 02593910 2007-07-18
- 18 -
below a longitudinally extending midline 542 of the gastric band 510. The tube
540 is
positioned so that is placed clear of the latching mechanism 520 and obliquely
angled
relative to the longitudinal axis (in accordance with a preferred embodiment
at an angle
of approximately 34 ) of the gastric band 510 to allow easy insertion through
a trocar.
[0073] Referring to Figure 23, the tube 640 is molded on the second end 634
of the balloon 614.
In particular, the tube 640 is molded at the very end of the balloon 614, and
is integrated
into the balloon shape. As with the prior embodiment, the tube 640 is
obliquely oriented
relative to the longitudinally axis of the gastric band 610 and is similarly
positioned
below a longitudinally extending midline of the gastric band 610. The offset
allows for
the balloon ends 632, 634 to meet without interference from the tube 640.
[0074] A further embodiment is shown with reference to Figure 24, wherein
the tube 740 exits
the balloon 714 off a lateral side 744, that is, a very bottom surface, of the
balloon 714 as
it is positioned within the patient. The tube 740 entry point is substantially
aligned with
the second latching member 726 relative to the longitudinal axis of the
gastric band 710.
As with the prior embodiments, the tube 740 is obliquely oriented relative to
the
longitudinally axis of the gastric band 710.
[0075] As shown in Figures 25 and 26, the tube 840 connection is integrated
into one of the sides
of the latching members. In accordance with the disclosed embodiment, it is
integrated
into the second latching member 826, although it is contemplated it could be
integrated
with the first latching member 822 without departing from the spirit of the
present
invention. The tube 840 enters the second latching member 826 and extends
therethrough into the body of the balloon 814. Once the tube 840 is inside the
body of
the balloon 814, it angles to the centerline (or midline 842) of the balloon
814 for even
filling of saline. The tube 840 is also obliquely oriented relative to the
longitudinally axis
of the gastric band 810 and is similarly positioned below a longitudinally
extending
midline 842 of the gastric band 810. The offset allows for the balloon ends
832, 834 to
meet without interference from the tube 840.
CA 02593910 2007-07-18
- 19 -
[0076] Yet other embodiments are shown respectively with reference to
Figures 27 and 28. In
accordance with one embodiment as shown in Figure 27, the tube 940 is molded
into the
plug 946 used to cap the core portion of the balloon 914. In accordance with
the other
embodiment as shown in Figure 28, the tube 1040 is molded as an integral
portion of the
second latching member 1026. The fluid passageway, therefore, extends through
the tube
1040, into passageways 1048 formed in the second latching member 1026 and
ultimately
into the balloon 1014. More particularly, once the tube 1040 enters into a
bridge of the
second latching member 1026 (that is, where the second latching member 1026
defines
the aperture), it splits into a bifurcated tube 1052 that goes into the
balloon 1014 via both
walls 1054 of the aperture 1030 of the second latching member 1026.
[0077] Still another embodiment is shown in Figures 29 and 30, wherein the
tube 1140 is
integrated into one of the sides of the latching mechanism 1120, preferably,
the second
latching member 1126. The tube 1140 then runs through a gusset 1156 from the
back of
the second latching member 1126 to allow for a low entry angle into the
balloon 1114.
[0078] Referring to Figure 31, the tube 1240 entry is integrated into the
belt 1212 (and more
particularly, the second latching member 1226) to allow for separate molding
of the belt
1212 and balloon 1214. By being attached to the second latching member 1226,
the tube
1240 could be used to find the location of the latching mechanism 1220 once
the implant
has been encapsulated into the fibrous tissue. As with the prior embodiments,
the tube
1240 is obliquely oriented relative to the longitudinally axis of the gastric
band 1210 and
is similarly positioned below a longitudinally extending midline 1242 of the
gastric band
1210. The offset allows for the balloon ends 1234 to meet without interference
from the
tube 1240.
[0079] In addition, any of the tubing configurations disclosed with
reference to Figures 22
through 31 could incorporate some type of strain relief member to reduce
fatigue as the
tubing flexes back and forth in the body. Such strain relief would be achieved
by
positioning a length of thicker material at the tubing entry point into the
balloon (see for
CA 02593910 2007-07-18
- 20 -
example 1156 on Figure 29, similarly shown but not called out in Figure 31).
The length
of thicker material allows the tubing to take a larger curve as it is bent
away from the
joint between the tube and the balloon. In other words, this length of
material that has
been thickened increases the stiffness of the tubing in this region to allow
the tubing to
flex without kinking and moves the point of flexing further away from the
vulnerable
joint between the band, balloon, and tubing. The strain relief member would be
made
preferably of silicone, but other materials (plastics, metals, etc.) could
also be used. Also,
in all of these embodiments, the tubing to could be connected to either the
belt or the
balloon by any one of multiple manufacturing methods, such as overmolding or
assembling and gluing.
[0080] Although the present invention is described for use in conjunction
with gastric bands,
those skilled in the art will appreciate the above invention has equally
applicability to
other types of implantable bands. For example, bands are used for the
treatment of fecal
incontinence. One such band is described in U.S. Pat. No. 6,461,292. Bands can
also be
used to treat urinary incontinence. One such band is described in U.S. Patent
Application
Publication No. 2003/0105385. Bands can also be used to treat heartburn and/or
acid
reflux. One such band is described in U.S. Patent No. 6,470,892. Bands can
also be used
to treat impotence. One such band is described in U.S. Patent Application
Publication No.
2003/0114729.
[0081] Referring to Figures 1 and 2, the extender 100 includes an elongated
body member
having a first end 102 and second end 104. The first end 102 includes an open
recess 106
shaped and dimensioned to receive the tab 24 of the first latching member 22
at the first
end 14 of the gastric band 10. The first end 102 of the extender 100 is
further provided
with a tether strap 108. The tether strap 108 is shaped and dimensioned for
passage
through the aperture 38 formed in the tab 24 and ultimate attachment within a
coupling
indent 110 formed in the outer surface of the first end 102 of the extender
100. In this
way, the tether strap 108 extending from the extender 100 loops through the
tab 24
CA 02593910 2007-07-18
- 21 -
readily coupling the first end 102 of the extender 100 the first latching
member 22 for
selective attachment and detachment.
[0082] The second end 104 of the extender 100 includes a gripping section
112 shaped and
dimensioned to facilitate gripping thereof as the extender 100 is passed
through the collar
member 26 and the gastric band 10 is applied around a patient's stomach. In
addition,
there is a suture loop 105 for compatibility with Goldfinger instruments 150
as discussed
above and the gripping section, or flat end, 112 of the extender 100 is
compatible with
other band passing devices. Between the first end 102 and the second end 104
of the
extender 100 is formed a laterally extending retention member 114. The
retention
member 114 is semi-circular when viewed along a planar, transverse cross
section. The
retention member 114 tapers to widen as it extends toward the first end 102 of
the
extender 100 in a manner creating a surface over which the collar member 26
may slide
during latching for interim attachment of the extender 100 to the collar
member 26. The
taper creates an engagement surface 118 which holds the collar member 26
between the
enlarged first end 102 of the extender 100 and the retention member 114 when
the first
end 102 of the extender 100 is temporarily latched to the collar member 26.
[0083] Although an extender with a recess and retention member in
accordance with a preferred
embodiment is disclosed above, the extender may take other forms without
departing
from the spirit of the present invention. For example, and in accordance with
another
preferred embodiment shown with reference to Figure 9, the extension member
200
includes an elongated body member having a first end 202 and second end 204.
The first
end 202 includes an enclosed, pocket recess, more particularly a pocket, 206
shaped and
dimensioned to fully receive the tab 24 of the first latching member 22 at the
first end 14
of the gastric band 10. The first end 202 of the extension member 200 is
further provided
with a tether strap 208. The tether strap 208 is shaped and dimensioned for
passage
through the aperture 38 formed in the tab 24 and ultimate attachment within a
coupling
indent 210 formed in the outer surface of the first end 202 of the extension
member 200.
CA 02593910 2007-07-18
- 22 -
In this way, the first end 202 of the extension member 200 may be readily and
selectively
secured and detached from the first latching member 22.
[0084] The second end 204 of the extension member 200 includes a series of
protrusions 212
shaped and dimensioned to facilitate gripping thereof as the extension member
200 is
passed through the collar member 26 and the gastric band 10 is applied around
a patient's
stomach. The second end 204 also includes a suture loop 205 extending
therefrom.
Between the first end 202 and the second end 204 of the extension member 200
is formed
a laterally extending retention member 214. The retention member 214 includes
first and
second engagement members 216, 218. The engagement members 216, 218 are
tapered
to widen as they extend toward the first end 202 of the extension member 200
in a
manner creating a surface over which the collar member 26 may slide during
latching for
interim attachment of the extension member 200 to the collar member 26 prior
to
complete latching of the gastric band 10 latching mechanism 20 (after which
the
extension member 200 is detached from the gastric band 10). The taper creates
opposed
engagement surfaces 220, 222 which hold the collar member 26 between the
enlarged
first end 202 of the extension member 200 and the engagement members 216, 218
when
the first end 202 of the extension member 200 is temporarily latched to the
collar member
26.
[0085] Regardless of the extender construction utilized in accordance with
a gastric band, it is
important the extender be readily accessed for removal with little possibility
for error.
The two key issues in removal of an extender revolve around a surgeon's
ability to
identify the extender, in particular, that part of the extender requiring
manipulation for
removal thereof, and proceed to remove the extending in accordance with the
removal
mechanism employed. With this in mind, various embodiments for ensuring clear
visualization and convenient cutting have been developed. Any of the
embodiments
described below can incorporate a visual indicator such as color (on either
the entire
extender, the tether strap, or the only the region to be cut) or a visible
suture to indicate to
the surgeons that this is a separate component from the gastric band that
should be
CA 02593910 2007-07-18
- 23 -
removed. In addition, these embodiments also provide various means in which
the
extender may be attached to the gastric band (tether strap, suture, etc.).
[0086] More particularly, and with reference to Figures 32, 33, 35 and 36,
the extender 1300
adjacent the first end 1302 thereof or the tether strap 1508, 1608 of the
extender 1500,
1600 is provided with one or more bumps or ramps 1330, 1530, 1630 at a
location
adjacent the open coupling indent, or pocket, 1310 into which the tether strap
1308, 1508,
1608 of the extender 1300, 1500, 1600 is to be positioned. By providing a bump
or ramp
1330, 1530, 1630 at this position (on either the first end of the extender or
on the tether
strap), the tether strap 1308, 1508, 1608 is held above the first end 1302 and
the surgeon
is able to readily visualize the location of the tether strap 1308, 1508,
1608. The bump or
ramp 1330, 1530, 1630 location is at a position adjacent the point at which
the tether
strap 1308, 1508, 1608 is to be cut for removal of the extender 1300, 1500,
1600 and,
therefore, provides the surgeon a visual indicator as to the cut location. In
accordance the
embodiment shown with reference to Figure 35, two bumps 1530a, 1530b wrap
completely around the tether strap 1508 and define an area at which a surgeon
should cut
the tether strap 1508.
[0087] In addition to improving visualization of the tether strap, in each
embodiment the bumps
or ramp raise the tether slightly above the gastric band, increasing the space
between the
tether and the gastric band to provide an improved passageway for position
scissors
therein for cutting of the tether and ultimate removal of the extender.
Visualization of the
cutting location in accordance with this embodiment is enhanced by providing a
gap or a
notch 1332, 1432, 1532 along the tether strap 1308, 1408, 1508 (see Figures
32, 33, 34
and 35). In particular and with reference to Figures 32, 33 and 43, the suture
loop at the
second end of the extender 1300, 2200 is continued throughout the body of the
extender
1300, 2200 with the suture 1334, 2234 extending through the tether strap 1308,
2208 and
functioning as a reinforcing member. However, a portion of the suture 1334,
2234 is
exposed along the tether strap 1308, 2208 at a predetermined location such
that when the
tether strap 1308, 2208 is passed through aperture 38 of the gastric band tab
24 and
CA 02593910 2007-07-18
- 24 -
wrapped about the gastric band 10 to secure the two components together, the
gap 1332,
2232 is positioned at the desired location for cutting.
[0088] Similarly, and as is seen if Figures 34 and 35, the tether strap
1408, 1508 may have a
localized region that is smaller than the remainder of the tether strap 1408,
1508 allowing
for cutting in a single step. More particularly, the localized region is
preferably a notch
1432, 1532 formed along the tether strap 1408, 1508. In addition, because the
gap or
notch 1432, 1532 is readily differentiated based upon its physical appearance
from the
remainder of the tether 1408, 1508, a surgeon may easily identify the location
requiring
cutting. It is contemplated either the notch or gap design could be used in
conjunction
with the bump described above with reference to Figure 32, 33, 36, 42 and 43,
although
these designs could certainly be employed without the bump where certain
design
considerations dictate.
[0089] Other embodiments are disclosed with reference to Figures 37, 39 and
40. These
embodiments employ a reinforcing member, for example, a suture 1734, 1934 to
aid in
the connection of the extender 1700, 1900 to the tip of the gastric band. In
one
application (see Figure 37), the suture 1734 holds the tether strap 1708 down
upon the
body thereof. As such, and rather than cutting the tether strap 1708 itself as
disclosed
above with reference to the various embodiments, the securing suture 1734 is
cut to
thereby release the tether strap 1708 for removal of the extender 1700.
Alternately, the
suture may be used to tie down the strap and as such, secure the tether to the
extender
without the assistance of adhesive.
Although a suture is disclosed as a reinforcing
member in accordance with a preferred embodiment, other reinforcing
structures, for
example, mesh, may be used within the spirit of the present invention.
[0090] In another related embodiment shown in Figure 39 and 40, the suture
material of the
suture loop 1905 is extended to run the length of the extender 1900 such that
the suture
material 1934, extends from the first end 1902 of the extender 1900
(substantially
replacing the tether of the prior embodiments). This allows the extender 1900
to wrap a
CA 02593910 2007-07-18
_
- 25 -
suture 1934 through an aperture 38 in the tip of the gastric band 10 and
engage a
projection 1936 extending from the first end 1902 of the extender 1900. In
addition to
securing the gastric band in a reliable and convenient manner, this embodiment
provides
additional benefits in that the suture 1934 now has a loop at the first end
1902 and the
second end 1904 of the extender 1900. This increases the strength of the
extender 1900
because the suture cannot pull out of the extender independent of extender
material
failure.
[0091] Referring to Figure 38, another embodiment is disclosed. In
accordance with this
embodiment, the tip 1812 of the gastric band 1810 is seated within the recess
1806
formed in the extender 1800. However, the recess 1806 and the tip 1812 of the
gastric
band 1810 include a snap feature providing a semi-mechanical locking mechanism
between the gastric band 1810 and the extender 1800. Such an embodiment would
improve the ability of the extender 1800 to lead and guide the tip 1812 of the
gastric band
1810 in concert without twisting or flipping.
Such a semi-mechanical locking
mechanism could be utilized in conjunction with the other tether securing
arrangements
as a means for providing redundant securing of the extender to the gastric
band. It is
further contemplated this embodiment may have suture 1811 around the tip 1812
of the
gastric band 1810 and the recess 1806 of the extender 1800 (like Figure 37) to
compress
the region where the snap fitting tip 1812 fits within the recess 1806 of the
extender
1800. When the surgeon cuts and removes the surrounding suture 1811, they can
then
expand the flexible silicone extender 1800 over the snap fitting tip 1812 on
the front of
the tab to separate the extender 1800 from the gastric band 1810 in one piece.
[0092] Further and with reference to Figure 41, a suture 2034 is
similarly utilized in securing the
extender 2000 to the gastric band. However, the projection 2036 to which the
extender
2000 is secured is designed such that it may be peeled away. As such, when it
is desired
to remove the extender 2000, one need only peel away the projection 2036 to
release the
extender 2000 and thereby no cutting is required.
CA 02593910 2014-02-03
- 26 -
[0093] Referring to Figure 42, another embodiment is disclosed. In
accordance with this
embodiment, the tether 2108 of the extender 2100 is lengthened to allow the
glue position
2138 to be moved a forward position on the open recess 2106 extender 2100.
This allows
the tether 2108 of the extender 2100 to be cut at line 2140 to remove the
extender 2100.
More particularly, the open recess 2106 includes a forward and 2106a
positioned toward
the middle of the extender 2100 and a rearward position 2106b positioned near
the first
end 2102 of the extender 2100. The glue position 2138 is at the forward end
2106a. This
is still a one-piece removal, only the length of the location for cutting has
changed. This
embodiment allows the tether 2108 to bow for improved access with scissors or
other
tools when the front of the extender is flexed upwardly since the tether is
only glued at
one end 2106a.
[0094] In accordance with yet another embodiment, and with reference to
Figure 43, a flange or
stopper 2242 is positioned at a preset point along the length of the tether
2208. This
enables positioning of the gap 2232 in the tether 2208 relative to the
position of the
extender 2200 where the suture 2234 needs to be cut and to avoid having
suturing contact
with the gastric band hole during band pulling. The stopper 2242 is positioned
to engage
the tab surrounding the aperture so as to limit the extent to which the tether
2208 may
pass therethrough. The portion of the tether 2208 adjacent the stopper 2242
may be
tapered and the section that is positioned inside the aperture of the gastric
band can be
larger in cross section to provide a snug fit with the hole of the gastric
band. As with
prior embodiments the tether will includes a gap or notched section for
identification and
cutting thereof In addition, the suture loop runs fully through the extender
and may be
utilized by tying it into a knot that is molded within the enlarged section of
the stopper so
as to improve the strength of the extender tether.
[0095] It will become readily apparent to those skilled in the art that the
above invention has
equally applicability to other types of implantable bands. For example, bands
are used
for the treatment of fecal incontinence. One such band is described in U.S.
Patent
6,461,292. Bands can also be used to treat urinary incontinence. One such band
is
CA 02593910 2014-02-03
=
-27 -
described in U.S. Patent Application 2003/0105385. Bands can also be used to
treat
heartburn and/or acid reflux. One such band is described in U.S. Patent
6,470,892.
Bands can also be used to treat impotence. One such band is described in U.S.
Patent
Application 2003/0114729.
[0096]
The scope of the claims should be given the broadest interpretation
consistent with the
description as a whole.
