Title of Invention

AN IMPLANTABLE BAND

Abstract The invention relates to an implantable band (70, 254, 258), the band comprising an inextensible strap (16, 32, 100) configured to encircle an anatomical passageway, said strap defining a circumferential direction thereabout, said strap having an inner (34) and outer surface (36) said strap comprising material having at least one first material property; an inflatable balloon (18, 38) extending inwardly from adjacent the inner surface of the strap; first and second end portions (42, 40; 74, 72,118,114; 174,172, 208, 206; 212, 210; 262, 260) disposed at either end of said strap, said first and second end portions including respective inner and outer surfaces which correspond to said inner and outer surfaces of said strap; and an integral attachment mechanism (110, 170, 204, 256) configured to attach said first end portion (42, 74, 118, 174, 208, 212, 262) to said second end portion (40, 72,114,172, 206, 210, 260) so as to secure said strap adjacent the anatomical passageway, said attachment mechanism comprising material having at least one second material property, said at least one second material property being different from said at least one first material property.
Full Text Randal T. Byrum
Jeffrey P. Wiley
Sean P. Conlon
Bill Fender
Mark Tsonton
Mark Ortiz
Adam Dunki-Jacobs
Related Application
This application claims the priority of provisional patent applications serial
numbers 60/483,353 filed on June 27, 2003, titled Adjustable Gastric Band
Having An Improved Attachment Mechanism, and 60/507, 612 filed on
September 30, 2003, titled Implantable Band With Deformable Attachment
Mechanism the disclosures of which are incorporated herein by reference.

This present invention relates generally to a surgically implantable band for
encircling an anatomical passageway, and is particularly directed to an adjustable
gastric band for encircling the stomach for the control of obesity. The invention
will be specifically disclosed in connection with an improved attachment
mechanism for an adjustable gastric band.
BACKGROUND OF THE INVENTION
Since the early 1980s, adjustable gastric bands have provided an effective
alternative to gastric bypass and other irreversible surgical weight loss
treatments for the morbidly obese. 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 that restricts food passing from an upper
portion to a lower digestive portion of the stomach. When the stoma is of the
appropriate size, food held in the upper portion of the stomach provides a feeling
of fullness that discourages overeating.
In addition to a latched position to set the diameter of the gastric band,
adjustability of gastric bands is generally achieved with an inwardly directed
inflatable balloon, similar to a blood pressure cuff, into which fluid, such as
saline, is injected through a fluid injection port to achieve a desired diameter.
The balloon is typically deflated or only partially inflated when first placed in the
body to allow for body adjustments and healing around the new band site. Since
adjustable gastric bands may remain in the patient for long periods of times, the
fluid injection port is typically installed subcutaneously to avoid infection, for

instance in front of the sternum. Following the initial implantation, the surgeon
may adjust the band by loosing or tightening depending on the patients' needs.
Adjusting the amount of fluid in the adjustable gastric band is achieved by
inserting a Huber tip needle through the skin into a silicone septum of the
injection port. Once the needle is removed, the septum seals against the hole by
virtue of compressive load generated by the septum. A flexible conduit
communicates between the injection port and the adjustable gastric band.
An attachment mechanism for the adjustable gastric band has to provide an
initial sizing of the stoma of the stomach. One generally known attachment is to
suture ends of the adjustable gastric band. Another generally known attachment
includes one end of the gastric band terminating in a flexible conduit that has a
flared portion that is drawn through an opening in a second end of the gastric
band and then sutured to the encircling band portion - securing the band to the
stomach. After the sutures are in place, the injection port is anchored at a
convenient location.
United States patent no. 5,938,669 discloses an adjustable gastric banding
device having a band connected by a tube to a control box and a balancing
reservoir implanted under a patient's skin, the box containing an electric pump
and an electronic control unit capable of communicating by radio with a monitor
carried by the patient and with a controller intended for the doctor. The

controller can operate the pump by remote control to transfer determined
volumes of liquid in a closed circuit from the band to the reservoir or vice versa,
to adjust the diameter f a passage in the stomach.
United States patent no. 5,226,429 discloses a gastric band adapted for
laparoscopic placement around the stomach and a method for deploying the
band. Cameras are used for observing the placement of the band. The band is
secured against slippage after being placed at the desired position.
European patent application publication no. 1 319 371 discloses a strip to be
implanted surgically, to form a restrictive ring around the stomach, has a closure
near the transit between the feed tube and the loop section. The free end of the
loop section has threading length for the closure, with lateral beads at the ends,
and a plug with a locking hook to fit into the eyelet of the closure.
International patent application publication no. WO 2004/108025 discloses a
surgical ring comprising a flexible band and a closure means which has male and
female elements for connecting two ends of the band. The female element has a
structural discontinuity at which the deformability of the female element is
greater than the rest of the female element.
European patent application publication no. 1 396 242 discloses a surgical ring
comprising a flexible band and a closure means for forming a closed loop. The

band and the closure means preferably form a single piece of the same material.
While these known approaches are effective in securing the gastric band, further
improvements are desires that simplify the clinical implantation procedure, that
provide long-term reliability, and that facilitate readjustment or removal.
While sutures have been relied on as the most positive connection in the past, it
is desirable to have a secure attachment that does not require sutures yet does
not require a large force to create the secure attachment. Otherwise, it may be
difficult to adequately grip and perform the attachment with laparoscopic
instruments. Consequently, a significant need exists for an adjustable gastric
band having an improved attachment mechanism.
SUMMARY OF THE INVENTION

[0008] The present invention addresses these and other problems in the prior
art, by providing an adjustable gastric band device that is engaged with
less force, thereby facilitating implementation with laparoscopic
instruments, yet the attachment remains secure over long term use.
[0009] A general object of this invention is to provide an adjustable gastric
band which comprises material having at least one first material
property and having an attachment mechanism which comprises
material that has at least one second material property corresponding to
but different from the first material property. The attachment
mechanism may include plastically or elastically deformable material.
[0010] Another object of this invention is to provide a readily reversible
adjustable gastric band which can be fastened and unfastened without
reducing the holding strength of the attachment mechanism.
[0011] A still further object of this invention is to provide an attachment
mechanism requiring a light force to latch and a high force to unlatch
the ends.
Brief Description Of The Figures
[0012] The accompanying drawings, which are incorporated in and constitute
a part of this specification, illustrate embodiments of the invention,
and, together with the general description of the invention given above,
and the detailed description of the embodiments given below, serve to
explain the principles of the present invention.
[0013] FIG. 1 is a diagrammatic drawing showing an adjustable gastric band
wrapped around an upper part of a stomach.
[0014] FIG. 2 is a cross sectional view of the adjustable gastric band of FIG 1
taken along line 2-2.

[0015] FIG. 3 is a top plan view of an adjustable gastric band having an
attachment mechanism comprising dissimilar, plastically deformable
material.
[0016] FIG. 4 is an enlarged fragmentary view of the end portions of the band
shown in Fig. 3.
[0017] FIG. 5 is cross sectional view taken along line 5-5 of FIG. 4.
[0018] FIG. 6 is cross sectional view taken along line 6-6 of FIG. 4.
[0019] FIG. 7 is cross sectional view taken along line 7-7 of FIG. 6.
[0020] FIG. 8 is a top plan view in partial cross section of another
embodiment of an adjustable gastric band having an attachment
mechanism comprising dissimilar, elastically deformable material.
[0021] FIG. 9 is an enlarged fragmentary view of the attachment mechanism
of FIG. 8.
[0022] FIG. 10 is an enlarged fragmentary cross sectional view similar to FIG.
9 of another embodiment of an attachment mechanism comprising
dissimilar, elastically deformable material.
[0023] FIG. 11 is an enlarged fragmentary top plan view in cross section of
another embodiment of an attachment mechanism comprising
dissimilar, elastically deformable material.
[0024] FIG. 11A is an end view of the receiver shown in FIG. 11.
[0025] FIG. 12 is an enlarged fragmentary top plan view in cross section of
the embodiment depicted in FIG. 11, showing the attachment
mechanism connected together.
[0026] FIG. 13 is an enlarged fragmentary perspective view of another
embodiment of an attachment mechanism comprising dissimilar,
elastically deformable material.

[0027] FIG. 14 is an enlarged fragmentary perspective view of the
embodiment shown in FIG. 13, showing the attachment mechanism
connected together.
10028] FIG. 15 is an enlarged cross section taken along line 15-15 of FIG. 14.
[0029] FIG. 16 is an enlarged exploded perspective view of another
embodiment of an attachment mechanism comprising dissimilar
material including an elastically deformable component.
[0030] FIG. 17 is an enlarged perspective view in cross section of the housing
shown in FIG. 16.
[0031] FIGS. 18-20 are views similar to FIG. 17, with the insert disposed in
the housing, showing various positions of the insert during operation.
[0032] FIGS. 21-23 are top views of the attachment mechanism shown in
FIGS. 16-20.
[0033] FIG. 24 is an enlarged fragmentary perspective view of another
embodiment of an attachment mechanism comprising dissimilar,
elastically deformable material.
[0034] FIG. 25 is an enlarged fragmentary perspective view of the
embodiment shown in FIG. 24, showing the attachment mechanism
connected together.
[0035] FIG. 26 is enlarged fragmentary perspective view of the embodiment
shown in FIG. 24, showing the attachment mechanism in an
intermediate stage of disconnecting the ends of the adjustable gastric
band.
[0036] Reference will now be made in detail to the present preferred
embodiment of the invention, an example of which is illustrated in the
accompanying drawings.

Detailed Description of Embodiments of the Invention
[0037] In the following description, like reference characters designate like or
corresponding parts throughout the several views. Also, in the
following description, it is to be understood that terms such as front,
back, inside, outside, and the like are words of convenience and are not
to be construed as limiting terms. Terminology used in this patent is
not meant to be limiting insofar as devices described herein, or
portions thereof, may be attached or utilized in other orientations.
Referring in more detail to the drawings, the invention will now be
described.
[0038] Referring to Fig. 1, an adjustable gastric band 10 is shown wrapped
around an upper portion of a stomach 12, kept in place by attaching the
two ends together and extending a portion 14 of the stomach 12 over
the adjustable gastric band 10 by suturing portion 14 to the stomach.
Referring also to Fig. 2, the adjustable gastric band 10 includes a non-
extensible strap 16 and an inflatable balloon 18, made of a medical
grade silicone polymer or any other suitable material, is carried by the
inner surface 20 of the strap 16. The balloon 18 may be secured to the
inner surface 20 in any well known manner, or even made of unitary
construction with the strap 16, although the strap 16 may typically be
formed of a different material.
[0039] One end of a flexible conduit 22 is in fluid communication with the
internal cavity 24 of the balloon 18, with the other end being in fluid
communication with an internal cavity (not shown) of a remote
injection port 26. The remote injection port 26 includes a silicone
septum 28. At the time the adjustable gastric band 10 is implanted
around a portion of the stomach, the remote injection port 26 is also
implanted at a suitable location, usually within the rectus sheaths, for
transcutaneous access via a Huber needle.


[0040] As is well known, the internal cavity 24, the flexible conduit 22 and
the internal cavity of the remote injection port 26 are preferably at least
partially filled with a physiologically compatible fluid, such as a saline
solution. Postoperative adjustment of the perimeter enclosed by the
balloon 18, and therefore the size of the stoma, is accomplished by
addition or removal of fluid from the interior cavity 24 of the balloon
18 by inserting a Huber needle percutaneously into the silicone septum
28 of the injection port 18.
[0041] As is well known in the field the adjustable gastric band 10 may be
made from any suitable medically compatible material having
sufficient strength necessary for a particular laparoscopic surgery or
particular patient.
[0042] As mentioned above, the two ends of the adjustable gastric band 10 are
attached together (the specific attachment mechanism structure is not
illustrated in detail in FIG. 1).
[0043] The present invention is directed to various embodiments of
attachment mechanisms, for connecting the two ends together, which
comprise a material that has at least one material property which
different from that of the material of which the band is primarily
comprised. The general construction of adjustable gastric band 10
shown in FIGS. 1 and 2 and described above is common to the
embodiments illustrated in FIGS. 3-7, with the embodiments differing
by the specific attachment mechanisms. It is noted that the practice of
the present invention may be used with any band, and is not limited to
use with an adjustable gastric band having the exact features described
above or below.
[0044] Turning now to FIG. 3, the adjustable gastric band 30 includes an
elongated strap 32 extending in what is referred to herein as the
longitudinal direction, even though when implanted the adjustable

gastric band 30 has an arcuate configuration. The strap 32 includes an
inner surface 34 and an outer surface 36, with the balloon 38 extending
inwardly from adjacent the inner surface 34. The adjustable gastric
band 30 includes a first end portion 40 which overlaps a second end
portion 42. The first and second end portions 40, 42 are secured
together by a deformable attachment mechanism.
[0045] Referring also to FIG. 4, in the embodiment depicted, the first end
portion 40 of strap 32 has a first portion of the attachment mechanism
associated with it depicted as an elongated cylindrical shaft portion 44
having a plurality of engagement members 46, shown as frustroconical
annular flanges 46, axially spaced along the shaft portion 44, angled
away from the distal end 44a. The second end portion 42 of strap 32
has a second portion of the attachment mechanism associated with it
depicted as a laterally extending member 48 which extends generally
perpendicularly from the outer surface 36.
[0046] The member 48 is configured to receive the first end portion 40.
Referring also to FIGS. 6 and 7, the laterally extending member 48 at
least partially defines a cavity, also referred to as a passageway, 50
which is configured to receive the first end portion 40. The member 48
includes two spaced apart legs 52, 54, which extend from the outer
surface 36, and define a gap 56 therebetween. Gap 56 leads to the
passageway 50.
[0047] As seen in FIG. 7, the surface 50a of passageway 50 is configured to
cooperate with the engagement members 46 to resist axial withdrawal
of the first end portion 40 from the passageway 50. More specifically,
passageway 50 includes a plurality of axially spaced, generally annular
shaped retention members 58, also referred to as rings 58, whose
annular shape is interrupted by gap 56. In the embodiment depicted,
each retention member 58 includes a generally frustroconical surface


58a and a generally transverse (to the longitudinal direction) retention
surface 58b.
[0048] The passageway 50 and a portion of gap 56 is surrounded by a
retention actuator 60, shown as a "U" shaped member although any
suitable shape may be used, disposed completely within the member
48. The actuator 60 is made of any material which may be easily
plastically deformed, or crimped to the desired shape without breaking,
so as to urge the retention members 58 against the shaft 44 to produce
increased resistance to withdrawal, axially or laterally, of the first end
portion 40. Thus, at least this one material property of the actuator 60,
plastic deformability which is not preceded by significant elastic
deformation, a relatively low yield point, is different from the
corresponding material property of the material from which the rest of
the strap 16 is made. Energy is imparted to the actuator 60 to
plastically deform it, resulting in secure attachment of the first end
portion 40 to the second end portion 42.
[0049] More specifically, crimping deforms the actuator 60 causing it to
squeeze against the shaft 44, causing the retention members 58 to
present greater resistance to axial movement of the engagement
members 46 in the direction of the arrow 62. Crimping may also close
the gap 56.
[0050] To attach the first end portion 40 to the second end portion 42, the
shaft 44 is pushed through the passageway 50. It is possible with the
embodiment illustrated to set the band 30 to more than one diameter by
advancing the shaft 44 through the passageway 50 to a desired
position, with the engagement members 46 meeting minimal resistance
to such axial movement from the frustroconical surfaces 58a. Once in
the desired position, the actuator member 60 can actuate the
attachment mechanism by being crimped with a grasper or other
suitable device. To detach the two ends, the closed gap 56 may be


spread apart such as by spreading the opposing surfaces of the gap 56
apart with a grasper.
[0051] The actuator 60 may be made of any biologically suitable material
which provides the desired deformation and force when crimped, such
as a plastically deformable metal. Although the actuator 60 is shown
completely disposed within the second end portion 42, such as insert
molded, the actuator 60 may extend beyond the exterior surface so
long as it remains retained to the second end portion 42 in some
manner, and the integrity of the second end portion 42 is preserved.
The width of gap 56 is selected to provide sufficient clearance to lay
the shaft 44 therethrough and to be closed by crimping so that
deformation of the actuator 60 is not unduly limited.
[0052] Referring now to FIGS. 8 and 9, another embodiment is illustrated
having a deformable attachment mechanism which is elastically
deformable. The adjustable gastric band 70 includes a first end portion
72 and a second end portion 74, shown attached together with the inner
surfaces 76 at each end 72 and 74 abutting each other. The first end
portion 72 includes a first portion of the attachment mechanism
associated with it depicted as a laterally extending member 78 which
extends generally perpendicularly from the inner surface 76 of end 72.
The member 78 is configured to engage the second portion of the
attachment mechanism associated with the second end portion 74.
More specifically, the laterally extending member 78 defines a
passageway 80 in conjunction with the inner surface 76 at the first end
portion 72 which is configured to receive the second end portion 74.
The member 78 includes two spaced apart legs 82 and 84 which extend
from the inner surface 76 at the opposite edges of the strap 70, with a
cross member 86 extending therebetween.
[0053] The second portion of the attachment mechanism associated with the
second end portion 74 is depicted as including a retaining member 88


extending laterally from the outer surface 90 thereof. The retaining
member 88 includes an inclined surface 92 which may be arcuate as
shown, or planar. The retaining member 88 also includes the retention
surface 96 which extends generally perpendicular from the outer
surface 90, and perpendicular to any relative movement between the
first and second end portions 72 and 74. The retention surface 96 must
extend above the upper edge of the passageway 80 a distance sufficient
to provide the desired force to resist disengagement. In the
embodiment depicted, the retention surface 96 extends slightly beyond
the top of the cross member 86.
[0054] The retaining member 88 includes a member 98, preferably made of a
dissimilar material, or at least having dissimilar resilience properties,
from the rest of strap 100. In particular, in this embodiment, the
elasticity of the material from which member 98 is made is different
than the elasticity of the material from which the strap 100 is made,
having greater elasticity so as to bias the retaining member resiliently
toward the shape shown. With the configuration illustrated, the greater
elasticity allows easier compression of the retaining member 88 when
inserting it through the passageway 80.
[0055] In the embodiment disclosed, the member 98 is diagrammatically
shown as a coil spring, disposed in a cavity 102 formed in retention
member 88. The cavity 102 with the member 98 may be formed using
any suitable method, such as a two step molding process, insert
molding, or other known techniques. The presence of cavity 102
allows retention member 88 to deflect in the lateral direction more
easily than if the cavity was the same material as the rest of the band
100, typically silicone. The member 98 is laterally resilient, urging the
retention member 88 outwardly so as to maintain the retention surface
96 in a position that requires high longitudinal force to separate the two
ends. With the laterally resiliency of member 98, perpendicular to the


direction of removal, and the cavity 102, only a relatively light lateral
force is required to move the retention surface 96 below or nearly
below the cross member 86 to a position that does not block or
presents reduced resistance to withdrawal of the second end portion 74
from the passageway 80.
[0056] The dissimilar material, elastically deformable element and cavity
within which it is disposed may be of any suitable shape. Referring to
FIG. 10, an another embodiment of a resilient member 104 is
diagrammatically illustrated disposed in the cavity 106. The member
104 has a "V" shape, with the wide end opening toward the retention
surface 108.
[0057] Referring to FIG. 11, there is shown another embodiment of an
attachment mechanism, generally indicated at 110, which includes a
receiver 112 carried by the first end portion 114, and a resilient
member, illustrated as a dual cantilever spring 116 carried by the
second end portion 118. The receiver 112 and the spring 116 may be
made of any suitable medically compatible material having sufficient
strength. In the embodiment depicted, the receiver 112 and the spring
116 are made of an injection moldable polymer which are insert
molded into the first and second end portions 114 and 116 of the
adjustable gastric band (not numbered in FIG. 11), which is made of
silicon. The material properties of the material from which the
receiver 112 and the spring 116 different from the material properties
of the material from which the strap is made. In particular in this
embodiment as illustrated, the material is stiffer, more rigid and harder
than the material (ejg., silicone) of the strap.
[0058] Referring also to FIG. 11A. the receiver 112 includes two pairs of
spaced apart side walls 120, 122, 124 and 126 which defines a cavity,
also referred to as a pocket, 120 that is configured to receive the two
spaced apart legs 130 and 132 of the spring 116. The side walls 122


and 124 include two openings 134 and 136 which are configured to
receive the ends 138 and 140 of the legs 122 and 124. Each end 138
and 140 include a respective step 142 and 144 which is dimensioned to
respectively engage the side 146 and 148 of the respective opening
134 and 136 to resist withdrawal from the pocket 128, as described
below.
[0059] The spring 116 includes steps 150 and 152 extending outwardly from a
respective leg 138 and 140. The second end portion 118 is molded
about a portion of the spring 116 retaining it thereto, with the legs 138
and 140 extending from the end 154. There are recessed surfaces 156
and 158, which may include surface texturing or protuberances as
illustrated, generally aligned with the steps 150 and 152, providing a
location to grasp the second end portion 118 to squeeze the ends 138
and 140 toward each other.
[0060] Referring also to FIG. 12, to connect the attachment mechanism 110
together, the legs 130 and 132 are inserted into the pocket 128. The
ends 138 and 140 includes ramps 160 and 162 which engage corners
164 and 166 upon insertion, compressing the legs 130 and 132 toward
each other as the legs are advanced into the pocket 128. The material
and construction of the spring 116 provides resiliency to the two legs
138 and 140. The ends 138 and 140 are advanced into the pocket 128
until they can move outwardly to snap into the openings 134 and 136
and hold the two end portions 114 and 118 together with end 154
generally abutting end 168.
[0061] As depicted, the openings 134 and 136 extend completely through the
spaced apart side walls 122 and 124, respectively, of the receiver 112
and the steps 142 and 144 do not extend outside of the openings. The
openings 134 and 136 are depicted as being covered by the silicon
material of the end portion 114. Once attached as show, the receiver


112 and spring 116 are not exposed, enclosed within the band shroud,
posing no erosion threat to the surrounding tissue.
[0062J To detach the first end portion 114 from the second end portion 118,
the recessed surfaces 156 and 158 are squeezed inwardly, causing the
legs 130 and 132 to move inwardly until the ends 138 and 140
withdraw from the openings 134 and 136, and the spring 116 can be
withdrawn from the receiver 112. The recessed surfaces 156 and 158
may be squeezed by use of a grasper.
[0063] Referring to FIGS. 13-15, there is shown yet another embodiment of
an attachment mechanism, indicated generally at 170 which includes a
first end portion 172 and a second end portion 174 made of the same
material as the rest of the band, such as silicon. The first end portion
172 includes a conically shaped retention member 176, more
specifically illustrated as a frustroconical shape, disposed adjacent an
annular groove 178 separating a first cylindrical portion 180 and the
base 182 of retention member 176. A second cylindrical portion 184
extends between the first cylindrical portion and the retention member
176. Extending from the opposite end of retention member 176 is
another cylindrical portion 186.
[0064] The second end portion 174 defines an internal, generally cylindrical
cavity 188, also referred to as an opening, which is shaped
complementarity to and configured to receive the first end portion 172,
as depicted having an inner diameter slightly larger than the outer
diameter of the first cylindrical portion 180 by an amount sufficient to
allow the first end portion 172 to be inserted into the cavity 188 in the
manner described below. Second end portion 174 includes two spaced
apart transverse slot openings 190 and 192 in communication with the
internal cavity 188, disposed on opposite sides of the second end
portion 174.


[0065] A resilient member 196, depicted as a generally U shaped spring clip
having two legs 198 and 200 extending from a base 202, generally
parallel to each other in the free state. The spring clip 196 may be
made of any suitable medically compatible material providing the
necessary resilience and strength. One or more material properties of
the material from which the spring clip 196 is formed is different than
the corresponding one or more material properties of the material from
which the strap is made. In the depicted embodiment, the spring clip
196 has more hardness, rigidity, stiffness, resiliency and elasticity than
the strap.
[0066] The spring clip 196 is carried by the second end portion 174 with the
legs 198 and 200 disposed partially in the openings 190 and 192,
respectively. The end portions of the legs 198a and 200a extend
beyond the openings 190 and 192, and terminate in curved portions.
The base 202 is molded into the second end portion 174, leaving the
legs 198 and 200 free to be spread outwardly to allow retention
member 176 to pass between the legs 198 and 200.
[0067] In the free state, the distance between the legs 198 and 200 is sufficient
to permit the leading end 176a of retention member 176 to pass
therebetween. Preferably, the diameter of end 176a is smaller than the
corresponding distance between the legs 198 and 200. To connect the
attachment mechanism 170 together, the first end portion 172 is
inserted into the cavity 188. The inclined shape of the retention
member 176 spreads the legs 198 and 200 apart as the first end portion
172 is advanced into the cavity 188, until the openings 190 and 192 are
aligned with groove 178, whereat the legs 198 and 200 move into the
groove 178, preferably being resiliently urged against the cylindrical
portion 184 as seen in FIG. 15, but at least move to a position
sufficient to retain the first end portion 172 within the cavity 188
adjacent the base 182 of retention member 176.


[0068J To detach the first end portion 172 from the second end portion, the
legs 198 and 200 are pulled apart far enough to allow the base 182 to
pass therebetween. This may be accomplished by use of a grasper.
[0069] Referring generally to FIGS. 16-23, and in particular to FIG. 16 and
FIGS. 21-23, there is shown another embodiment of an attachment
mechanism, indicated generally at 204, of an adjustable gastric band
254, which includes a first end portion 206 and a second end portion
174. FIG. 16 illustrates the attachment mechanism 204, without the
band, in an exploded perspective view. The first end portion 206
carries the insert assembly 210 and the second end portion 208 carries
the housing assembly 212. The insert assembly 210 and housing
assembly 212 may be attached to the first and second end portions 206
and 208, in any suitable manner. In the depicted embodiment, insert
assembly 210 and housing assembly 212 have been molded into the
end portions 206 and 206 respectively, aligned longitudinally with the
band 254. It is noted that the insert assembly 210 and housing
assembly 212 could alternatively be oriented lateral or transverse to the
band 254.
[0070] In the depicted embodiment, the insert assembly 210 includes the
insert 214, a cap 216 and a retainer 218. The insert 214 is rotatably
connected to the cap 216 by retainer 218. As depicted, the insert 214
includes a hole 220 which is configured to receive part of the retainer
218, which is illustrated as a threaded pin, although any suitable
retainer or retaining structure may be used. The cap 216 also includes
a hole 222 through which the threaded shaft portion 218a of retainer
218 extends to engage with the internal threads of hole 220. The cap
216 may include a counterbore or other recess (not shown) in its
surface disposed adjacent the upper end 214a of the insert 214. Such a
recess may be shaped complementarily to the adjacent portion of insert
214 so as to receive a portion of insert 214 while still allowing


sufficient rotation of insert 214. Any configuration which allows an
insert to be carried suitably freely rotating by the first end portion 206
may be used.
[0071] The insert 214 includes three legs 224, each of which includes a
radially extending portion 224a and an axially extending portion 224b.
Although three spaced legs 224 are depicted, there may be one or more
spaced apart legs. In the embodiment depicted, legs 224 are equally
circumferentially spaced, having 120° angles between them. Although
the axially extending portions 224b are continuous and aligned with
the radially extending portions 224a, the function of the legs 224 can
be achieved without being continuous and aligned.
[0072] In the depicted embodiment, the housing assembly 212 includes the
housing 226, the resistor 228, biasing member 230, depicted as an
elastically deformable coil spring, and end cap 232. Referring also to
FIG. 17, the housing 226 defines an internal cavity, also referred to as
a bore, 234. The first portion 234a, also referred to as the entrance
portion, of bore 234, starting at the upper end 226a of housing 226, has
a nominal diameter which is complementary to the nominal outer
diameter (not including the legs 224) of the insert 214. A plurality of
longitudinal slots 236 are formed extending outwardly from the inner
surface 234b of the entrance portion 234a. The slots 236 are
configured to receive the legs 224, the number and spacing of slots 236
matching the number and spacing of the legs 224. The width
(circumferentially) and the depth (beyond the inner surface 234b) of
the slots 236 are sized to provide clearance for the legs 224 to slide
axially therethrough with no or little axial force required. As will be
described, since the insert 214 rotates within the housing 226 to
connect and disconnect (actuate and deactuate) the attachment
mechanism 204, it is preferable that the legs 224 and the slots 236 be
equally and uniformly spaced, circumferentially/angularly.


[0073] The bore 234 includes a second portion 234c. The second portion
234c has a diameter provides diametrical clearance for the legs 224 so
that the insert 214 may freely rotate within the housing 226 once the
legs 224 have cleared the slots 236, as will be described below. In the
depicted embodiment, the diameter of the second portion 234c is
substantially the same as the depth of the slots 236, with the inner
surface 234d being continuous with the bottoms 236a of slots 236.
[0074] The entrance portion 234 defines a plurality of arcuate ramps 238 and
240 which extend outwardly relative to the inner surface 234b a
distance that provides diametrical clearance for the legs 224. The ramp
238 extends between the lower end of the longitudinally extending side
236b to the upper end of the longitudinally extending stop surface 242.
The ramp 240 extends between the lower end of the stop surface 242 to
the lower end of the longitudinally extending side 236c. In the
depicted embodiment, the inner surface 234d extends to the ramps 238
and 240.
[0075] A plurality of longitudinal slots 244 are formed extending outwardly
from the inner surface 234d from the lower end of second portion
234c. The slots 244 are configured to receive the legs 228a of the
resistor 228, providing enough clearance for the legs 228a to slide
axially slide axially therealong with no or little axial force required,
until stopped by the ends 244a. The number and spacing of slots 244
match the number and spacing of the legs 228. In the depicted
embodiment, the grooves 244 and the legs 228 are equally and
uniformly spaced, circumferentially/angularly, although any number
and orientation which provide the desired function may be used.
[0076] Referring also to FIG. 18, the inner surface 234d is shaped
complementarily to the outer surface 228b of the resistor 228 which is
disposed in the bore 234. In the depicted embodiment, the surface
228b is cylindrical and has a diameter which is smaller than the


diameter of the inner surface 234d by an amount sufficient to allow the
resistor 228 to slide axially therein with no or little axial force
required. To retain the resistor 228 within the housing 226, the end
cap 232 is secured to the lower end 226b, with biasing member 230
disposed between the lower end of the resistor 228 and the upper end
of the cap 232, urging the resistor 228 toward the entrance end 234a.
The cap 232 and the lower end 226b may be connected together in any
suitable manner, such as threads.
[0077] The resistor 228 includes a plurality of inclined ramps 246 and
declined ramps 248 (in the clockwise direction when viewed from the
top) which intersect at radially oriented peaks 250 and valleys 252.
The ramps 246 and 248, and the axially extending portion 224b are
configured to cooperate together to bias the insert 214 rotationally as
the insert 214 is urged against the resistor 228 during actuation and
deactuation of the attachment mechanism 204. In the depicted
embodiment, the axially extending portions 224b each include a lower
surface 224c which terminates in a radially oriented edge 224d which
is configured to engage the ramps 246 and 248 of the resistor 228. As
will be appreciated, the configurations of the ramps 246 and 248, the
axially extending portions 224b, the surfaces 224c and the edges 224d
must be complementary to each other at the smaller circumferential
distances approaching the center of the end of the insert 214, to avoid
interference. Other configurations may be used which achieve the
same functionality of these features. For example, the axially
extending portions 224b may extend only axially, aligned with the rest
of legs 224, not radially inward beyond the circumference of the insert
214.
[0078] FIGS. 18-20 illustrate various positions of the insert 214 during
actuation and deactuation of the attachment mechanism 204. It is
noted that in FIGS. 18-20, the curvature of ramps 238' is opposite that


of the curvature illustrated in FIG. 17. The shapes of the ramps and the
legs may be any suitable shapes which cooperate together to achieve
the indexed rotation of the insert 214 as described below.
[0079] In FIG. 18, the insert 214 is illustrated disposed at least partially in the
bore 234 of the housing 216, with each leg 224 being disposed within a
respective slot 236. When the legs 224 are so located, each edge 224d
of the axially extending portions 224b is disposed to engage respective
declined ramps 248. When the insert 214 is advanced axially into the
bore, the declined surfaces of the ramps 248 bias the edges 224d
rotationally, but rotation is initially prevented by stop 236b, until the
insert 214 has been advanced far enough into the bore 234 for the
upper edges 224e to clear the lower ends 238a' of the sides 236b/lower
end of the ramps 238'. The resistor 228 moves axially within bore 134
as the insert 214 advances, but does not rotate.
[0080] Once the upper edges 224e have cleared the lower ends 238a', and the
insert 214 can rotate, the declined surfaces of the ramps 248 cause the
insert to rotate until the lower edges 224d reach the valleys 252, which
are the terminuses of the declined surfaces 248-the portions of the
declined surfaces 248 at which rotation of the insert ceases. At this
location, the upper edges 224e have rotated past the lower ends 238a',
and underlie the ramps 238'.
[0081] When the axial force on insert 214 is then released, the upwardly
biased resistor 228 urges the insert 214 upwardly, through the contact
of edges 224d with the inclined ramps 246, urging the upper edges
224e into engagement with the ramps 238'. It is noted that the upper
edges 224e may be the only part of the radially extending portion 224a
that contacts the surfaces 238', as illustrated in FIG. 18, or the surfaces
224f may be configured to engage the ramps 238' in addition to
engagement by the edges 224e, as illustrated in FIGS. 19 and 20, or to
engage the ramps 238' instead of the upper edges 224e.


[0082] FIG. 19 illustrates the engagement of the upper edges 224e and
surfaces 224f with the ramps 238', which exert an advancing
(clockwise in the illustration) rotational bias on the insert 214.
Concomitant with the upward biasing by the resistor 228, the inclined
ramps 246 resist the advancing rotation of the insert 214. However,
the advancing rotational bias imparted by ramp 238' is sufficient to
overcome the resisting rotational bias imparted by the inclined ramps
246, and the insert 214 advances rotationally until rotation is stopped
by stop surface 242, as illustrated in FIG 20, and the insert is retained
in the bore 234 and the attachment mechanism 204 is actuated,
securing the ends of the band together.
[0083] As seen in FIG. 20, the lower edges 224d have advanced beyond the
peaks 250. To separate the ends of the band, the attachment
mechanism 204 is deactuated by depressing the insert 214, i.e.,
advancing the insert into the bore 234, urging the lower edges 224d
against the declined ramp 248. As with the actuation process, the
declined ramps 248 bias the edges 224 rotationally, but in this case
rotation is initially prevented by the stop surface 242, until the insert
214 has been advanced far enough into the bore 234 for the upper
edges 224e to clear the lower ends 242a of the stop surface 242.
[0084] Once the upper edges 224e have cleared the lower ends 242a, and the
insert 214 can rotate, the declined surfaces of the ramps 248 cause the
insert to rotate until the lower edges 224d reach the valleys 252. At
this location, the upper edges 224e have rotated past the lower ends
242a, and underlie the ramps 240'.
[0085] When the axial force on insert 214 is then released, the upwardly
biased resistor 228 urges the insert 214 upwardly, through the contact
of edges 224d with the inclined ramps 246, urging the upper edges
224e into engagement with the ramps 240'. As mentioned above in
reference to surfaces 238, the upper edges 224e may be the only part


of the radially extending portion 224a that contacts the surfaces 240'.
or the surfaces 224f may be configured to engage the ramps 240' in
addition to engagement by the edges 224e or to engage the ramps 238'
instead of the upper edges 224e.
[0086] The engagement of the upper edges 224e and surfaces 224f with the
ramps 240' exert an advancing rotational bias on the insert 214, with
the inclined ramps 246 resisting the advancing rotation of the insert
214. The advancing rotational bias imparted by ramp 240' is sufficient
to overcome the resisting rotational bias imparted by the inclined
ramps 246, and the insert 214 advances rotationally into the slots 236,
allowing the insert 214 to be withdrawn.
[0087] Referring to FIGS. 21-23, the attachment mechanism 204 is illustrated
being actuated. FIG. 21 illustrates the first and second end portions
206 and 206 prior to actuation, generally aligned and proximal to each
other. There are arrows 206a and 208a shown on the cap 216 and the
housing 226 in these figures to illustrate the rotation of the insert 214
during actuation, and may be, but not necessarily, included in the
actual device to allow visualization of the relative orientation and of
rotation of the insert 214 during actuation. The legs 224 are aligned
with the slots 236 so that the insert 214 may be inserted into the bore
234. FIG. 22 illustrates the insert 214 advanced into the bore 236, a
position at which the resistor 228 has moved axially. The insert 214 is
caused to rotate as it is inserted far enough, and upon release of the
axial force, is retained in the housing 226 as shown in FIG. 23, with
the arrows 206a and 208a aligned. Deactuation is accomplished by
advancing the insert 214 axially so it rotates, and then withdrawing it
from the bore 234.
[0088] The components of the attachment mechanism 204 may made of any
medically compatible materials, such as but not limited to metal,
plastic or a combination thereof. In the embodiment depicted, the


attachment mechanism 204 is made of different material(s) than the
band. The material properties of the material(s) from which the insert
assembly 210 and the housing assembly 212 are made are different
from the material properties of the material from which the strap is
made. Generally, the components are stiffer, more rigid and harder.
The biasing member 230 has greater elasticity and resiliency.
[0089] Referring to FIGS 24-26, there is shown another embodiment of an
attachment mechanism, indicated generally at 256, of an adjustable
gastric band 258, which includes a first portion of the attachment
mechanism associated with the first end portion 260 and a first portion
of the attachment mechanism associated with the second end portion
262. The first end portion 260, also referred to as a tongue portion,
may be formed of the same material as the band 258, and is depicted as
generally having the same width and thickness as the band 258.
[0090] In the embodiment depicted, the second portion 262 includes a
proximal section 264, which is proximal to the band 258, an
intermediate section 266, and a distal section 268. The edges 270 of
the proximal section 264 are roughened or textured in order to resist
unintended separation of the attachment mechanism 256, as described
below. The edges 270 are depicted as including a plurality of laterally
oriented ridges along the length of the proximal section 264. The
edges 270 may be roughened or textured along their entire lengths, as
depicted, but are not required to be. The inner surface 272 of the
proximal section 264 is depicted as textured, but it may alternatively
not be textured.
[0091] The intermediate section 266 includes a textured surface 274 which is
configured to resist, and preferably prevent, relative longitudinal
movement between the first end portion 260 and the second end
portion 262 when the attachment mechanism 256 is actuated, as
described below. A pair of outwardly opening recesses 276, also


referred to as release slots, may be formed in the intermediate section
266 adjacent the proximal section 264. The recesses 276 may
alternatively characterized as being be disposed adjacent the
intermediate section 266 and the proximal section 264, as disposed
between the intermediate and proximal sections, as disposed in the
proximal section 264 adjacent the intermediate section 266, or as
disposed in both the proximal and intermediate sections. It is the
location of the recess 276 relative to the latches (described below)
which is relevant to the operation of the attachment mechanism 256.
not such characterization.
[0092] The distal section 268 is pivotable relative to the intermediate section
266 through the hinge 278. Depending on the material, the hinge 278
may be an elastomeric hinge or a plastic living hinge.
[0093] The distal end 280 of the distal section 268 includes two spaced apart
latches 282 extending laterally from the edges of the distal end 280.
As depicted, the latches 282 define respective upright members having
inwardly facing surfaces 282a which are preferably spaced apart a
distance less than the distance between the edges 270. The distal end
280 may be tapered, the width of distal end 280 decreasing along its
length, or have a smaller width along its length in comparison to the
width between the edges 270, such that the inner surfaces 282a engage
the edges 270. The width of the first end portion 260, adjacent the
latches 282 when the attachment mechanism 256 is attached, the width
between the edges 270 and the width between surfaces 282a are
configured to allow the surfaces 282a to engage the edges 270.
[0094] The latches 282 defined inwardly extending surfaces 282b which
overlie the inner surface 284 of the distal end 280. The longitudinal
widths of the latches 282, and the transverse distance between the inner
surfaces 282c of the latches 282 allow the latches 282 to pass through
the recesses 276 without significant resistance, as described below.


[0095] Referring to FIG. 25, the inner surface 260a of the first end portion 260
is disposed adjacent the proximal section 264 and the intermediate
section 266, with the distal end 260b adjacent the hinge 278. The
distal section 268 is pivoted about the hinge 278 to capture the first end
portion 260 between the distal section 268 and the proximal and
intermediate sections 264 and 268. The distal section 268 exerts a
clamping force against the first end portion to urge the inner surface
260a proximal to the distal end 260b against the textured surface 274
between the first end portion 260 and the second end portion 262,
which may result at least in part due to the dimensions of the hinge
278. The inclined surfaces 282d of the latches 282 act to spread the
latches 282 apart allowing the latches 282 to be pushed downwardly
past the first end portion 260 and the proximal section 264, until the
inner surfaces 282c have cleared the edges 270, allowing the inwardly
facing surfaces 282a to engage edges 270 and the inwardly extending
surfaces 282b to abut or at least face the outer transverse surfaces
264a, in the latched position as shown in FIG. 25.
[0096] FIG. 26 illustrates the attachment mechanism in an intermediate stage
of being disconnected. To deactuate or disconnect the attachment
mechanism 256, the distal end is moved longitudinally relative to the
proximal section 264 and intermediate section 266, until the latches
282 are aligned with the recesses 276, allowing the distal ends of the
latches 282 to be moved laterally into the recesses 276 allowing the
proximal and intermediate sections 264 and 266 to pivot relative to the
distal section 268, thereby reducing the clamping force against the first
end portion 260. Once the clamping force has been reduced, the first
end portion may be separated from the second end portion 262.
[0097] The outer surfaces of the band 258 include pull tabs 286 and 288
which may be grasped using a grasper or other suitable instrument to
effect the movement of the distal end 280.


[0098] As mentioned above, the first end portion 260 may be made of the
same material as the band 258, which is typically silicon. The distal
end 280 may be made of any material having sufficiently rigid and
elastic material properties to provide the necessary resiliency to the
latches 282 and to produce the necessary clamping load to retain the
first end portion 260, such as a hard plastic material, and thus is made
of a material which is different from the rest of the band 258. The
entire second end portion 262 may be, but is not necessarily made from
a rigid material. Alternatively, any sections up to the distal end 280, or
possibly even up to the latches 282, may be made of the same material
or a material with similar properties as the material of the rest of the
band 258. For example, all of distal section 268 may be made of a
rigid material. The hinge 278 may be an elastomeric hinge or a plastic
living hinge. Another possibility is for the intermediate section 266 to
be made of a rigid material.
[0099] It is noted that the material of components of the above described
attachment mechanisms may be made of any suitable material or
materials having the one or more material properties necessary to
perform the function of that component. If the functional
requirement(s) of the component allow, the component may be made
of the same material as the strap portion of the band (or of course made
be made of a completely different material). For example, it may be
possible to make an attachment mechanism component of siliconc
having a higher Durometer than the strap made of silicone. In such
example, the Shore A Durometer of the silicone strap may be 50 ± 5,
with the component of the attachment mechanism having a Shore A
Durometer of at least about 10 higher than the strap.
[00100] 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 which is hereby
incorporated herein by reference. Bands can also be used to treat
urinary incontinence. One such band is described in U.S. Patent
Application 2003/0105385 which is hereby incorporated herein by
reference. Bands can also be used to treat heartburn and/or acid reflux.
One such band is described in U.S. Patent 6,470,892 which is hereby
incorporated herein by reference. Bands can also be used to treat
impotence. One such band is described in U.S. Patent Application
2003/0114729 which is hereby incorporated herein by reference.
[00101] Thus, as used herein and in the claims, an implantable band is a band
which may be implanted in a position to occlude flow, such as food or
body fluids, through an anatomical passageway, such as a stomach or
lumen.
[00102] In summary, numerous benefits have been described which result from
employing the concepts of the invention. The foregoing description of
one or more embodiments of the invention has been presented for
purposes of illustration and description. It is not intended to be
exhaustive or to limit the invention to the precise form disclosed.
Obvious modifications or variations are possible in light of the above
teachings. The one or more embodiments were chosen and described
in order to best illustrate the principles of the invention and its practical
application to thereby enable one of ordinary skill in the art to best
utilize the invention in various embodiments and with various
modifications as are suited to the particular use contemplated. It is
intended that the scope of the invention be defined by the claims
appended hereto.

WE CLAIM
1. An implantable band (70, 254, 258), the band comprising:
(a) an inextensible strap (16, 32, 100) configured to encircle an
anatomical passageway, said strap defining a circumferential
direction thereabout, said strap having an inner (34) and outer
surface (36) said strap comprising material having at least one first
material property;
(b)an inflatable balloon (18, 38) extending inwardly from adjacent the
inner surface of the strap;
(c) first and second end portions (42, 40; 74, 72, 118, 114; 174, 172,
208, 206; 212, 210; 262, 260) disposed at either end of said strap,
said first and second end portions including respective inner and
outer surfaces which correspond to said inner and outer surfaces of
said strap; and
(d)an integral attachment mechanism (110, 170, 204, 256) configured
to attach said first end portion (42, 74, 118, 174, 208, 212, 262) to
said second end portion (40, 72,114,172, 206, 210, 260) so as to

secure said strap adjacent the anatomical passageway, said
attachment mechanism comprising material having at least one
second material property, said at least one second material
property being different from said at least one first material
property.
2. The band as claimed in claim 1, wherein said attachment mechanism
comprises a first portion (88) associated with said first end portion (74,
114, 174, 212), and a second portion (78) associated with said second
end portion (72, 112, 172, 210), said first portion comprising a cavity (50,
102, 106, 128, 188, 234).
3. The band as claimed in claim 2, wherein said first portion (88) comprises
a first member extending laterally from said first end portion (74), at least
a part of said cavity (50,102,106) being defined by said member.
4. The band as claimed in claim 2 or 3, wherein said second portion
comprises a second member (78) extending laterally from said second end
portion (72), said second member defining a passageway configured to
have said first end portion (74) and said first member (88) passed
therethrough, said first member (88) and said second member (78)
configured to cooperate with each other to resist withdrawal of said first
member and said first end portion from said passageway.

5. The band as claimed in claim 2 or 3, comprising a resilient member (98,
104,196) at least partially disposed within said cavity (102,106,188).
6. The band as claimed in claim 5, wherein said resilient member (98, 104,
196) comprises said second material.
7. The band as claimed in claim 5, wherein said second portion comprises a
second member extending laterally from said second end portion, said
second member defining a passageway configured to have said first end
portion (108) and said first member passed therethrough, said first
member and said second member configured to cooperate with each
other to resist withdrawal of said first member and said first end portion
from said passageway.
8. The band as claimed in claim 5, wherein said cavity (188) is configured to
receive said second portion, said second portion comprising at least one
groove (178), said resilient member (196) located relative to said cavity to
engage said at least one groove (178) when said second portion is
disposed at least partially within said cavity (188) at a first position.
9. The band as claimed in claim 8, wherein said first portion comprises two
spaced apart openings (190,192) which communicate with said cavity

(188), and wherein said resilient member (196) comprises a generally U
shaped spring having two spaced apart legs (198, 200) extending from a
base (202), said being disposed within said first portion (174) and each of
said spaced apart legs being disposed at least partially within the
respective opening.
10.The band as claimed in claim 9, wherein said second end comprises at
least one inclined surface (176) configured to move said legs apart as said
second end is being moved to said first position.
11.The band as claimed in claim 2 or 3, wherein said cavity (50) comprises
plurality of spaced apart retention members (58).
12.The band as claimed in claim 11, wherein said retention members (58)
comprise annular rings.
13.The band as claimed in claim 11, wherein said second portion (40)
comprises a cylindrical portion.
14.The band as claimed in claim 13, wherein said cylindrical portion
comprises at least one engagement member (46) configured to cooperate
with said cavity (50) to resist axial withdrawal of said second portion (40)
from said cavity (50).

15.The band as claimed in claim 2 or 3, comprising a plastically deformable
member disposed adjacent said cavity.
16.The band as claimed in claim 15, wherein said cavity comprises plurality of
spaced apart retention members.
17.The band as claimed in claim 16, wherein said retention members
comprise annular rings.
18.The band as claimed in claim 15, wherein said first member comprises
two spaced apart legs.
19.The band as claimed in claim 2, wherein said first portion comprises a first
member extending in a longitudinal direction, said first member
comprising at least two spaced apart said walls which define at least a
part of said cavity (128), and wherein said second portion comprises at
least one resilient member (116) which is configured to be at least
partially disposed in said cavity and to engage at least one of said side
walls to resist withdrawal of said first member from said cavity.
2O.The band as claimed in claim 19, wherein said at least one resilient
member (116) comprises first and second spaced apart legs (138,140).

21.The band as claimed in claim 20, wherein each of said legs (138, 140)
comprise a respective outwardly extending step (150, 152) and wherein
said each of said spaced apart side walls includes a respective opening
(134, 136) configured to engage one of said steps so as to resist
withdrawal of said first member from said cavity (128).
22.The band as claimed in claims 19, 20 or 21, wherein said first member
and said second member are insert molded into said first end portion
(114) and said second end portion (118), respectively.
23.The band as clamed in claim 2, wherein said first portion (226) comprises
a first member, at least a part of said cavity (234) being defined by said
first member, said cavity comprising a generally cylindrical inner surface
(234a) defining an axis, a plurality of spaced apart slots (236) and a
plurality of ramps (238, 240), and wherein said second portion (214)
comprises a cylindrical member which is rotatable relative to said second
end portion, said cylindrical member comprising a plurality of outwardly
extending legs (224), said cylindrical member being configured to be
inserted into and to rotate within said cavity (234).
24.The band as claimed in claim 23, wherein said first portion comprises an
axially moveable member (228) disposed within said cavity (234), said
axially moveable member being resiliency axially biased so as to bias said
cylindrical member in a direction out of said cavity.

25.The band as claimed in claim 23, wherein said axially moveable member
(228) includes a plurality of inclined and declined ramps (246) configured
to engage said cylindrical member (214) and to bias said cylindrical
member rotationally.
26.The band as claimed in claim 23, wherein at least two of said plurality of
ramps (238, 240) are disposed circumferential between at least two
adjacent slots of the plurality of said slots (236), said cavity comprising at
least one slot disposed between said at least two of said plurality of
ramps.
27.The band as claimed in claim 23 through 26, wherein at least one of said
axis and said cylindrical extend in a longitudinal direction.
28.The band as claimed in claim 1, wherein said attachment mechanism
comprises said first end portion (262) comprising a distal section (268), a
proximal section (264) and a textured section (266) intermediate said
distal and proximal sections, said distal section being pivotable relative to
said textured section (262) and including a distal end (280) comprised of
said second material, said distal end (280) comprising at least one
laterally extending latch (282), said at least one latch configured to
engage said proximal section (264) when said distal section (268) is
disposed in a first position overlying said proximal and textured sections
with said second end portion (260) disposed inbetween said distal section
and said proximal and textured sections.

29.The band as claimed in claim 28, wherein said at least one latch (282) is
sized to engage-an outer surface of said proximal section (264) such that
said distal section urges said second end portion (260) against an inner
surface (274) of said textured section.
30.The band as claimed in claim 29, wherein the inner surface (274) of said
textured section (266) comprises a textured surface configured to engage
said second end portion (260) and to resist withdrawal of said second end
portion.
31.The band as claimed in claim 29, wherein said proximal section (264)
includes oppositely facing transverse edges (270), and said at least one
latch (282) comprises at least two spaced apart latches, each latch having
an inner surfaces (282a), each latch configured to engage one of said
transverse edges (270) with its inner surface, each of said transverse
edges being configured to resist relative movement of said latches along
said transverse edges.
32.The band as claimed in claim 31, wherein said transverse edges (270) are
textured.
33.The band as claimed in claim 32, wherein said transverse edges (270)
each comprise a plurality of laterally oriented ridges.

34.The band as claimed in claim 29, wherein the inner surface (272) of said
proximal section comprises a textured surface configured to engage said
second end portion (260) and to resist withdrawal of said second end
portion.
35.The band as claimed in claim 29, comprising a hinge (278) between said
textured section (266) and said distal section (268).
36.The band as claimed in claim 35, wherein said hinge (278) is an
elastomeric hinge.
37.The band as claimed in claim 35, wherein said hinge (278) is a living
hinge.
38.The band as claimed in claim 35, wherein said hinge is configured such
that distal end section (268) adjacent said hinge urges said second end
portion (260) against said inner surface (274) of said textured section
adjacent said hinge.
39.The band as claimed in claims 28 to 38, wherein said first end portion
(262) comprises a respective release slot (276) associated with a
respective one of said at least one latch, each said release slot being
configured to allow its associated latch to pass therethrough without
significant resistance.

40.The band as claimed in claim 39, wherein each said release slot (276) is
disposed adjacent said proximal section (264).
41.The band as claimed in claim 1, wherein said attachment mechanism
comprises a first portion associated with said first end portion, and a
second portion associated with said second end portion, said first portion
comprising a resilient member.
42.The band as claimed in claim 41, wherein said first portion comprises a
first member extending laterally from said first end portion, at least a
portion of said member comprising said second material.
43.The band as claimed in claim 42, wherein said second portion comprises a
second member extending laterally from said second end portion, said
second member defining a passageway configured to have said first end
portion and said first member passed therethrough, said first member and
said second member configured to cooperate with each other to resist
withdrawal of said first member and said first end portion from said
passageway.

The invention relates to an implantable band (70, 254, 258), the band
comprising an inextensible strap (16, 32, 100) configured to encircle an
anatomical passageway, said strap defining a circumferential direction
thereabout, said strap having an inner (34) and outer surface (36) said strap
comprising material having at least one first material property; an inflatable
balloon (18, 38) extending inwardly from adjacent the inner surface of the strap;
first and second end portions (42, 40; 74, 72,118,114; 174,172, 208, 206; 212,
210; 262, 260) disposed at either end of said strap, said first and second end
portions including respective inner and outer surfaces which correspond to said
inner and outer surfaces of said strap; and an integral attachment mechanism
(110, 170, 204, 256) configured to attach said first end portion (42, 74, 118,
174, 208, 212, 262) to said second end portion (40, 72,114,172, 206, 210, 260)
so as to secure said strap adjacent the anatomical passageway, said attachment
mechanism comprising material having at least one second material property,
said at least one second material property being different from said at least one
first material property.

Documents:

357-KOL-2004-FORM 15.pdf

357-KOL-2004-FORM-27.pdf

357-kol-2004-granted-abstract.pdf

357-kol-2004-granted-claims.pdf

357-kol-2004-granted-correspondence.pdf

357-kol-2004-granted-description (complete).pdf

357-kol-2004-granted-drawings.pdf

357-kol-2004-granted-examination report.pdf

357-kol-2004-granted-form 1.pdf

357-kol-2004-granted-form 18.pdf

357-kol-2004-granted-form 2.pdf

357-kol-2004-granted-form 26.pdf

357-kol-2004-granted-form 3.pdf

357-kol-2004-granted-form 5.pdf

357-kol-2004-granted-reply to examination report.pdf

357-kol-2004-granted-specification.pdf

357-kol-2004-granted-translated copy of priority document.pdf


Patent Number 234617
Indian Patent Application Number 357/KOL/2004
PG Journal Number 24/2009
Publication Date 12-Jun-2009
Grant Date 09-Jun-2009
Date of Filing 25-Jun-2004
Name of Patentee ETHICON ENDO-SURGERY, INC.
Applicant Address CREEK ROAD, CINCINNATI, OHIO
Inventors:
# Inventor's Name Inventor's Address
1 RANDAL BYRUM 1738 WESTPORT DR. KINGS MILLS, OH 45034
2 JEFFREY P. WILEY 5585 AUTUMN WYND LANE MILFORD, OH 45150
3 MARK TSONTON 6802 FAIRWIND COURT LOVELAND, OH 45140
4 MARK ORTIZ 1145 GLEN ECHO LANE MILFORD, OH 45150
5 SEAN, P. CONLON 6234C NORTH SHADOWHILL WAY LOVELAND, OH 45140
6 BILL FENDER 40 CARNOUSTIE LANE SPRINGBORO, OH 45066
7 ADAM DUNKI-JACOBS 33 E. 16TH AVENUE COLUMBUS, OH 43201
8 RANDAL BYRUM 1738 WESTPORT DR. KINGS MILLS, OH 45034
9 JEFFREY P. WILEY 5585 AUTUMN WYND LANE MILFORD, OH 45150
10 MARK ORTIZ 1145 GLEN ECHO LANE MILFORD, OH 45150
11 SEAN, P. CONLON 6234C NORTH SHADOWHILL WAY LOVELAND, OH 45140
12 BILL FENDER 40 CARNOUSTIE LANE SPRINGBORO, OH 45066
13 ADAM DUNKI-JACOBS 33 E. 16TH AVENUE COLUMBUS, OH 43201
14 MARK TSONTON 6802 FAIRWIND COURT LOVELAND, OH 45140
PCT International Classification Number A61F 5/00
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 60/483,353 2003-06-27 U.S.A.
2 60/507, 612 2003-09-30 U.S.A.
3 10/874, 881 2004-06-23 U.S.A.