U.S. patent application number 17/463205 was filed with the patent office on 2021-12-23 for devices and systems configured to fit around a tissue or organ and methods of using the same.
This patent application is currently assigned to CVDevices, LLC. The applicant listed for this patent is CVDevices, LLC. Invention is credited to Ghassan S. Kassab, Thomas A. Kramer.
Application Number | 20210393426 17/463205 |
Document ID | / |
Family ID | 1000005810914 |
Filed Date | 2021-12-23 |
United States Patent
Application |
20210393426 |
Kind Code |
A1 |
Kassab; Ghassan S. ; et
al. |
December 23, 2021 |
DEVICES AND SYSTEMS CONFIGURED TO FIT AROUND A TISSUE OR ORGAN AND
METHODS OF USING THE SAME
Abstract
Devices and systems to fit around a tissue or organ and methods
of using the same. In at least one embodiment of an implantable
device of the present disclosure, the implantable device comprises
a first engaging component comprising a first rigid inner plate at
least partially surrounded by a first flexible coating, a second
engaging component comprising a second rigid inner plate at least
partially surrounded by a coating selected from the group
consisting of the first flexible coating and the second flexible
coating, a first c-ring and a second c-ring coupled to the engaging
components, and a cover flap coupled to either the first engaging
component or the second engaging component and capable of either
further coupling to the second engaging component when initially
coupled to the first engaging component or further coupling to the
first engaging component when initially coupled to the second
engaging component.
Inventors: |
Kassab; Ghassan S.; (La
Jolla, CA) ; Kramer; Thomas A.; (San Carlos,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CVDevices, LLC |
San Diego |
CA |
US |
|
|
Assignee: |
CVDevices, LLC
San Diego
CA
|
Family ID: |
1000005810914 |
Appl. No.: |
17/463205 |
Filed: |
August 31, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15991226 |
May 29, 2018 |
11103375 |
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17463205 |
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14215829 |
Mar 17, 2014 |
9980841 |
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15991226 |
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61800687 |
Mar 15, 2013 |
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14215829 |
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13080586 |
Apr 5, 2011 |
8979876 |
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61800687 |
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12861251 |
Aug 23, 2010 |
9089391 |
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13080586 |
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12546139 |
Aug 24, 2009 |
9402757 |
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12861251 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 5/0086 20130101;
A61B 17/122 20130101; A61B 17/1227 20130101; A61F 5/0013
20130101 |
International
Class: |
A61F 5/00 20060101
A61F005/00; A61B 17/122 20060101 A61B017/122 |
Claims
1. A device, comprising: a first engaging component; a second
engaging component; a first c-ring coupled to the first engaging
component at a first pivot point and coupled to the second engaging
component at a second pivot point; and a cover flap coupled to
either the first engaging component or the second engaging
component; wherein each of the first engaging component and the
second engaging component define a longitudinal axis; wherein the
device is further configured for placement around at least part of
a stomach; and wherein the first c-ring is configured to swivel
from a first position that is substantially coplanar with the
longitudinal axis of the first engaging component and the
longitudinal axis of the second engaging component to a second
position that is substantially perpendicular with the longitudinal
axis of the first engaging component and the longitudinal axis of
the second engaging component.
2. The device of claim 1, wherein the second engaging component
comprises a first rigid inner plate at least partially surrounded
by a first flexible coating.
3. The device of claim 1, further comprising: a second c-ring
coupled to the first engaging component at a third pivot point and
coupled to the second engaging component at a fourth pivot
point.
4. The device of claim 3, wherein when the first c-ring and the
second c-ring are not positioned within an interior space defined
between the first engaging component and the second engaging
component when in the second position when the device is open.
5. The device of claim 2, wherein the first flexible coating
extends beyond a perimeter of a first rigid plate of the first
engaging component.
6. The device of claim 5, wherein when the first flexible coating
extends beyond a perimeter of the first rigid plate, the first
flexible prevents shearing and migration of the device when the
first engaging component and the second engaging component contact
the stomach.
7. The device of claim 1, further comprising: a first swivel stop
positioned along at least one of the first engaging component and
the second engaging component, the first swivel stop configured to
limit swiveling of the first c-ring.
8. The device of claim 3, wherein at least one of the first c-ring
and the second c-ring comprises at least one suture feature.
9. The device of claim 2, wherein the cover flap comprises a first
material surrounded at least substantially by a flexible
coating.
10. The device of claim 1, wherein at least one tab aperture is
defined within the cover flap, wherein one of the first engaging
component and the second engaging component further comprises a
tab, and wherein the tab is configured for insertion into the tab
aperture.
11. The device of claim 10, wherein one of the first engaging
component and the second engaging component further comprises a
loop coupled thereto, wherein at least a portion of the cover flap
is configured to fit within the loop.
12. The device of claim 1, wherein one of the first engaging
component and the second engaging component comprises a component
tab configured to fit within a tab receiver of at the other of the
first engaging component and the second engaging component.
13. The device of claim 3, wherein at least one of the first c-ring
and the second c-ring comprises a first c-ring portion and a second
c-ring portion, and wherein the first c-ring portion and the second
c-ring portion are configured to couple to one another by way of a
mechanism selected from the group consisting of a coupler, a post,
a slider coupler, a joiner, a c-ring stub, a hinge, and an
elongated coupler.
14. The device of claim 3, wherein at least one of the first c-ring
and the second c-ring comprises a metal insert at least
substantially surrounded by a flexible coating.
15. An implantable device, comprising: a first engaging component;
a second engaging component; a first c-ring coupled to the first
engaging component at a first pivot point and coupled to the second
engaging component at a second pivot point; and a cover flap
coupled to either the first engaging component or the second
engaging component; wherein each of the first engaging component
and the second engaging component define a longitudinal axis;
wherein the device is further configured for placement around at
least part of a stomach; wherein the first c-ring is configured to
swivel from a first position that is substantially coplanar with
the longitudinal axis of the first engaging component and the
longitudinal axis of the second engaging component to a second
position that is substantially perpendicular with the longitudinal
axis of the first engaging component and the longitudinal axis of
the second engaging component; wherein the first flexible coating
extends beyond a perimeter of the first rigid plate and wherein the
second flexible coating extends beyond a perimeter of the second
rigid plate; and wherein at least one tab aperture is defined
within the cover flap, wherein one of the first engaging component
and the second engaging component further comprises a tab, and
wherein the tab is configured for insertion into the tab
aperture.
16. A method for using an implantable device, the method comprising
the steps of: inserting an implantable device into a mammalian
body, the implantable device comprising: a first engaging
component, a second engaging component, a first c-ring coupled to
the first engaging component at a first pivot point and coupled to
the second engaging component at a second pivot point, and a cover
flap coupled to either the first engaging component or the second
engaging component, wherein each of the first engaging component
and the second engaging component define a longitudinal axis,
wherein the device is further configured for placement around at
least part of a stomach, and wherein the first c-ring is configured
to swivel from a first position that is substantially coplanar with
the longitudinal axis of the first engaging component and the
longitudinal axis of the second engaging component to a second
position that is substantially perpendicular with the longitudinal
axis of the first engaging component and the longitudinal axis of
the second engaging component; advancing the implantable device to
a location within the mammalian body adjacent to a targeted tissue;
swiveling the first c-ring so that the first c-ring is
substantially perpendicular to the first engaging component and the
second engaging component; and positioning the first engaging
component and the second engaging component over the targeted
tissue such that at least a portion of the targeted tissue is
positioned therebetween.
17. The method of claim 16, wherein when the targeted tissue
expands in a direction between the first engaging component and the
second engaging component, the targeted tissue exerts a force upon
the first engaging component and the second engaging component.
18. The method of claim 16, wherein the step of positioning is
performed to position the first engaging component and the second
engaging component over at least part of the stomach.
19. The method of claim 18, wherein the method is performed to
reduce a potential amount of food intake by reducing or eliminating
an amount of food that can enter a fundus of the stomach.
20. The method of claim 18, further comprising the step of:
securing the cover flap over a fundus of the stomach so that the
cover flap is secured to the first engaging component and the
second engaging component.
Description
PRIORITY
[0001] The present application is related to, claims the priority
benefit of, and is a U.S. continuation application of, U.S. patent
application Ser. No. 15/991,226, filed May 29, 2018 and issued as
U.S. Pat. No. 11,103,375 on Aug. 31, 2021, which is related to,
claims the priority benefit of, and is a U.S. continuation
application of, U.S. patent application Ser. No. 14/215,829, filed
Mar. 17, 2014 and issued as U.S. Pat. No. 9,980,841 on May 29,
2018, which a) is related to, and claims the priority benefit of,
U.S. Provisional Patent Application Ser. No. 61/800,687 filed Mar.
15, 2013, and b) is related to, claims the priority benefit of, and
is a U.S. continuation-in-part patent application of, U.S. patent
application Ser. No. 13/080,586, filed Apr. 5, 2011, which is
related to, claims the priority benefit of, and is a U.S.
continuation-in-part patent application of, U.S. patent application
Ser. No. 12/861,251, filed Aug. 23, 2010, which is related to,
claims the priority benefit of, and is a U.S. continuation-in-part
patent application of, U.S. patent application Ser. No. 12/546,139,
filed Aug. 24, 2009. The contents of each of these applications and
patents are hereby incorporated by reference in their entirety into
this disclosure.
BACKGROUND
[0002] Organ and tissue surgical restoration are clinical
techniques that may be applied to numerous different body tissues,
ranging from blood vessels to whole organs. Conventionally, such
surgical techniques require the use of incisions, pins, staples
and/or significant sutures in order to alter the tissue's anatomy.
For example, surgical gastric restoration often employed to treat
obesity and typically involves the reorganization of the digestive
tract. Conventional examples of such procedures involve attempts to
either 1) restrict food intake into the body via a restrictive
bariatric procedure (a "Restrictive Procedure"), or 2) alter the
anatomy of the small intestine or divert the peristalsis of a
person's normal food intake past the small intestine to decrease
caloric absorption via a malabsorptive bariatric procedure, which
is commonly known as a gastric bypass (a "Malabsorptive
Procedure"). It is also known to combine the two procedures such
that both of the aforementioned techniques are employed
jointly.
[0003] Malabsorptive Procedures entail an intestinal bypass that
results in the exclusion of almost all of the small intestine from
the digestive tract. In most Malabsorbptive Procedures, a portion
of the stomach or small intestine is removed from the digestive
tract through a surgical procedure that requires cutting the
digestive tissue and thereafter closing any holes or securing the
newly formed anatomy with staples and/or sutures. Conversely,
Restrictive Procedures generally involve the creation of a
passageway extending from the upper portion of the stomach to the
lower portion of the stomach in order to decrease the size of the
organ and thus prevent the stomach from storing large amounts of
food. Conventional Restrictive Procedures rely on the banding,
suturing and/or stapling of the stomach to create a small pouch on
the superior portion of the stomach near the gastroesophageal
junction.
[0004] Combined operations consisting of Malabsorptive and
Restrictive Procedures are the most common bariatric procedures
performed today. An example of a combined procedure is the Extended
(Distal) Roux-en-Y Gastric Bypass in which a stapling creates a
small stomach pouch (approximately 15 to 20 cc) completely
separated from the remainder of the stomach. In addition, the small
intestine is divided just beyond the duodenum (the hollow tube
connecting the stomach to the jejunum), re-arranged into a
Y-configuration, and sutured to the small upper stomach pouch to
enable the outflow of food therefrom through the newly formed "Roux
limb."
[0005] Accordingly, most digestive tract restoration procedures
require that the stomach and/or tissue of the intestine is cut and
thereafter sutured or stapled back together. As the digestive tract
contains numerous enzymes, strong acids and multiple species of
bacteria that assist with digestion, the perforation of an organ
and/or tissue thereof is particularly problematic due to the
likelihood of leakage therefrom and/or increased risk of serious
infection. As such, conventional gastric surgical restoration
procedures have high rates of post-operative complications that may
require prolonged hospitalization and even additional operations,
and are often irreversible and/or permanently affect the restored
tissue and/or organ. Accordingly, a need exists for safe and
effective devices and methods for restoring organs and tissue that
are reversible and do not require cutting or penetrating the
underlying tissue with significant sutures, staples and/or
pins.
[0006] It will be appreciated that the foregoing examples are only
provided as examples and that there are numerous other indications
where intervention is necessary either to restore the underlying
organ or tissue and/or to provide support thereto.
BRIEF SUMMARY
[0007] In at least one embodiment of an implantable restraining
device of the present disclosure, the device comprises a first
engaging component and a second engaging component, the first and
second engaging components configured for laparoscopic insertion
into a body cavity, and at least one connector coupled to the first
engaging component and the second engaging component. In at least
one embodiment, the at least one connector is capable of comprising
a first configuration relative to the first engaging component and
the second engaging component whereby the first engaging component
and the second engaging component are positioned relative to one
another to fit within a laparoscopic port, and is further capable
of comprising a second configuration relative to the first engaging
component and the second engaging component whereby the first
engaging component and the second engaging component are spaced
apart from one another so that an interior space having a value is
defined therebetween. In an additional embodiment, the at least one
connector is capable of moving between a first position that is
substantially parallel with the first engaging component and the
second engaging component, and a second position that is
substantially perpendicular with the first engaging component and
the second engaging component. In yet another embodiment, the first
engaging component and the second engaging component are configured
to engage a targeted tissue therebetween when the at least one
connector is/are in a second configuration relative to the first
engaging component and the second engaging component.
[0008] In at least one embodiment of an implantable restraining
device of the present disclosure, at least one of the first
engaging component and the second engaging component further
comprises one or more suturing elements chosen from the group of
one or more pads, one or more apertures, and/or one or more suture
members, each of the one or more suturing elements capable of
receiving a suture therethrough. In another embodiment, the first
engaging component and the second engaging component further
comprise one or more strings, wherein said strings may be coupled
to one another to secure the device about a stomach. In yet another
embodiment, the first engaging component and the second engaging
component each comprise a proximal end, a distal end, and a body
extending therebetween, wherein the body of the first engaging
component is configured to conform to a first targeted tissue
surface, and the body of the second engaging component is
configured to conform to a second targeted tissue surface. In an
additional embodiment, the at least one connector is rotatably
coupled with the body of the first engaging component and the body
of the second engaging component. In yet an additional embodiment,
the at least one connector comprises a first connector and a second
connector, wherein the first connector is coupled to the distal end
of the first engaging component and the distal end of the second
engaging component, and wherein the second connector is coupled to
the proximal end of the first engaging component and the proximal
end of the second engaging component.
[0009] In at least one embodiment of an implantable restraining
device of the present disclosure, each of the first engaging
component and the second engaging component comprise a
configuration chosen from a straight bar configuration, a curved
configuration, or a circular configuration. In an additional
embodiment, the first engaging component and the second engaging
component are flexible or semi-flexible. In yet an additional
embodiment, the first engaging component, the second engaging
component, and the at least one connector each comprise a material
suitable to resist corrosion, the material chosen from
polyurethane, polyethylene, polytetrafluoroethylene, nitinol,
silastic, titanium, and/or stainless steel. In another embodiment,
when a force is applied to the at least one connector, the value of
the interior space is increased.
[0010] In at least one embodiment of an implantable restraining
device of the present disclosure, the at least one connector
comprises at least one spring having at least one coil. In another
embodiment, the at least one spring comprises at least one torsion
spring. In yet another embodiment, the at least one coil of the at
least one spring comprises three or more coils. In an additional
embodiment, an outermost diameter of the at least one spring is
less than about 15 millimeters. In a further embodiment, the at
least one spring comprises a first rod and a second rod extending
from the coil, wherein the first rod is coupled to the first
engaging component and the second rod is coupled to the second
engaging component.
[0011] In at least one embodiment of an implantable restraining
device of the present disclosure, the value of the interior space
defined between the first engaging component and the second
engaging component when the at least one connector comprises a
second configuration corresponds to an outer dimension of a stomach
so that the device, when positioned about a stomach, fits about the
stomach without providing any clamping pressure upon said stomach.
In an additional embodiment, each of the first engaging component
and the second engaging component have a width between 5 mm and 15
mm and have a length between 30 mm and 200 mm. In yet an additional
embodiment, when the at least one connector comprises a first
configuration, the at least one connector operates to compress the
first engaging component and the second engaging component toward
one another so that the value of the interior space approaches
zero. In another embodiment, the first engaging component further
comprises one or more pads affixed thereto, each of the one or more
pads capable of receiving a suture therethrough.
[0012] In at least one embodiment of an implantable restraining
device of the present disclosure, the at least one connector
comprises at least one strut, the at least one strut rotatably
coupled to the first engaging component and the second engaging
component. In another embodiment, the at least one strut comprises
at least two struts, and wherein the device further comprises a
mesh curtain coupled to at least two of the at least two struts,
the mesh curtain operable to limit organ distension or remodeling
when the device is positioned about an organ. In an additional
embodiment, the mesh curtain defines at least one mesh aperture,
the at least one mesh aperture sized to permit a user to grasp an
organ within the at least one mesh aperture to facilitate
positioning the device about the organ. In yet an additional
embodiment, said device is sized and shaped so that a demi shaft
may engage the device so that the device may be positioned within a
body cavity, and removal of the demi shaft from the device allows
the first engaging component and the second engaging component to
separate from one another.
[0013] In at least one embodiment of an implantable restraining
device of the present disclosure, the device further comprises a
mesh curtain coupled to the first engaging component and the second
engaging component, the mesh curtain operable to limit organ
distension or remodeling when the device is positioned about an
organ. In another embodiment, the device further comprises pliable
junctions within the first engaging component and the second
engaging component to divide each component into two separate
subcomponents, wherein each of the two separate subcomponents of
the first engaging component and the second engaging component are
connected to one another by way of a flexible structure.
[0014] In at least one embodiment of an implantable restraining
device of the present disclosure, the at least one connector
comprises at least two connectors, the at least two connectors each
comprising a coupler, said coupler comprising at least two coupler
arms connected to a coupler bar. In an additional embodiment, each
of the first engaging component and the second engaging component
define apertures sized and shaped to fit said coupler arms so that
said coupler arms may inserted within said apertures. In yet an
additional embodiment, at least one of the at least two coupler
arms comprises a coupler protrusion positioned at or near a distal
end of said arms, and wherein the first engaging component and the
second engaging component comprise at least one stop at the
corresponding aperture where said arm comprises a coupler
protrusion, the coupler protrusion sized and shaped to restrict
removal of coupler from the first engaging component and the second
engaging component upon engagement of said stop. In another
embodiment, the at least two coupler arms of each coupler comprise
a pivot member positioned therethrough so that the at least two
coupler arms may pivot about one another at the pivot member. In
yet another embodiment, each of the first engaging component and
the second engaging component define apertures sized and shaped to
fit said coupler arms so that said coupler arms may inserted within
said apertures and so that said coupler arms may move in a lateral
direction corresponding to the first engaging component and the
second engaging component. In an additional embodiment, one or more
protrusions positioned within at least one aperture are capable of
facilitating fixation of coupler arms in a desired position.
[0015] In at least one embodiment of an implantable restraining
device of the present disclosure, the device comprises the first
engaging component and the second engaging component each define an
opening, said opening sized and shaped to accept arms of an
apparatus useful to position the device within a body cavity. In an
additional embodiment, the at least one connector comprises a
resorbable material, and wherein when the device is positioned
about a stomach, the at least one connector resorbs within a body
over time so that the at least one connector is no longer coupled
to the first engaging component and the second engaging component.
In yet an additional embodiment, the first engaging component and
the second engaging component comprise a resorbable material, and
when the device is positioned about a stomach, the first engaging
component and the second engaging component resorb within a body
over time so that the first engaging component and the second
engaging component are no longer coupled to one another by way of
the at least one connector. In another embodiment, at least one of
the first engaging component, the second engaging component, and
the at least one connector comprise a resorbable material chosen
from polyglycolide (PGA), polylactide (PLA), I-lactide (LPLA),
poly(dl-lactide) (DLPLA), poly(.epsilon.-caprolactone) (PCL),
poly(dioxanone) (PDO), polyglycolide-trimethylene carbonate
(PGA-TMC), or poly(d,l-lactide-co-glycolide) (DLPLG).
[0016] In at least one embodiment of an apparatus for delivering a
restraining device of the present disclosure, the apparatus
comprises a shaft comprising a distal end, the shaft defining a
lumen positioned therethrough, at least one arm operably coupled to
the shaft at or near the distal end of the shaft, the at least one
arm configured to engage a restraining device comprising a first
engaging component, a second engaging component, and at least one
connector coupled to the first engaging component and the second
engaging component, and at least one pull bar having a distal end,
the at least one pull par positioned at least partially within the
lumen of the shaft. In at least another embodiment, when a string
coupled to the at least one connector is engaged by the at least
one pull bar at or near the distal end of the at least one pull
bar, the at least one pull bar is operable to change the
configuration of the at least one connector upon retraction of the
at least one pull bar within the lumen of the shaft. In an
additional embodiment, the at least one arm comprises a first arm
and a second arm, the first arm operable to engage the first
engaging component of the restraining device and the second arm
operable to engage the second engaging component of the restraining
device. In yet an additional embodiment, movement of the first arm
and the second arm in a first direction facilitates the separation
of the first engaging component from the second engaging
component.
[0017] In at least one embodiment of an apparatus for delivering a
restraining device of the present disclosure, the apparatus
comprises a shaft comprising a proximal end and a distal end, the
shaft defining a lumen positioned therethrough, at least one arm
operably coupled to the shaft at or near the distal end of the
shaft, the at least one arm configured to engage a restraining
device comprising a first engaging component, a second engaging
component, and at least one connector coupled to the first engaging
component and the second engaging component, and at least one
string rotator, the at least one string rotator positioned at or
near the proximal end of the shaft, wherein when a string coupled
to the at least one connector is engaged by the at least string
rotator, the at least one string rotator is operable to change the
configuration of the at least one connector upon rotation of the at
least one string rotator.
[0018] In at least one embodiment of a system for restoring a
tissue of the present disclosure, the system comprises an exemplary
implantable restraining device of the present disclosure and an
exemplary an apparatus for delivering the restraining device of the
present disclosure.
[0019] In at least one embodiment of a method for restoring a
targeted tissue of the present disclosure, the method comprising
the steps of inserting an exemplary implantable restraining device
of the present disclosure into a body cavity, increasing the value
of the interior space between the first engaging component and the
second engaging component of the device by positioning the at least
one connector in a second configuration, and positioning the first
engaging component and the second engaging component of the device
over the targeted tissue such that the targeted tissue is
positioned within the interior space, wherein when the targeted
tissue expands in a direction between the first engaging component
and the second engaging component, the targeted tissue exerts a
force upon the first engaging component and the second engaging
component. In another embodiment, the targeted tissue is a stomach,
and expansion of the stomach, with said device positioned thereon,
functionally divides the stomach into a first stomach portion and a
second stomach portion. In yet another embodiment, the targeted
tissue is a stomach and wherein the first engaging component and
the second engaging component comprise one or more suturing
elements positioned at or near the distal ends of each said
component, the one or more suturing elements capable of receiving a
suture therethrough to approximate the distal ends of said
components toward one another. In an additional embodiment, said
approximation of the distal ends of the first engaging component
and the second engaging component toward one another prevents a
fistula so that food entering the stomach enters a first stomach
portion and not the stomach fundus. In yet an additional
embodiment, the distal ends of the first engaging component and the
second engaging component extend beyond the stomach when the device
is positioned over the stomach.
[0020] In at least one embodiment of an implantable restraining
device of the present disclosure, the device comprises a first
engaging component and a second engaging component configured for
laparoscopic insertion into a body cavity, wherein at least one of
the first engaging component and/or the second engaging component
comprises one or more suturing elements, and wherein the first
engaging component and the second engaging component each comprise
a material suitable to resist corrosion, and at least one connector
coupled to the first engaging component and the second engaging
component, the at least one connector capable of comprising a first
configuration relative to the first engaging component and the
second engaging component whereby the first engaging component and
the second engaging component are positioned relative to one
another to fit within a laparoscopic port, the at least one
connector capable of comprising a second configuration relative to
the first engaging component and the second engaging component
whereby the first engaging component and the second engaging
component are spaced apart from one another so that an interior
space having a value is defined therebetween, wherein when the
device is positioned about a stomach, the device fits about the
stomach without providing any clamping pressure upon said
stomach.
[0021] In at least one embodiment of a method for removing a
restraining device from a body of the present disclosure, the
method comprising the steps of withdrawing a restraining device
from a tissue or organ to which it is positioned, configuring the
restraining device fit within a laparoscopic port, and removing
restraining device from the body through the laparoscopic port. In
another embodiment, said method is preceded by the step of
positioning the laparoscopic port within the body to facilitate
removal of the restraining device. In yet another embodiment, the
method further comprises the step of removing the laparoscopic port
from the body.
[0022] In at least one exemplary embodiment of an implantable
restraining device of the present disclosure, the device comprises
a first engaging component and a second engaging component, each
component configured for laparoscopic insertion into a body cavity,
a first swivel arm defining a first bend and a second swivel arm
defining a second bend, the first swivel arm coupled to the first
engaging component at a first pivot point and coupled to the second
engaging component at a second pivot point, and the second swivel
arm coupled to the first engaging component at a third pivot point
and coupled to the second engaging component at a fourth pivot
point, and a first interconnection arm and a second interconnection
arm, the first interconnection arm connected to the first swivel
arm relative to the first bend, and the second interconnection arm
connected to the second swivel arm relative to the second bend. In
another embodiment, the first swivel arm and the second swivel arm
are capable of moving between a first position that is
substantially parallel with the first engaging component and the
second engaging component and a second position that is
substantially perpendicular with the first engaging component and
the second engaging component. In yet another embodiment, the first
engaging component and the second engaging component are configured
to engage a targeted tissue therebetween when the first swivel arm
and the second swivel arm are in a configuration relatively
perpendicular to the first engaging component and the second
engaging component. In an additional embodiment, the first engaging
component and the second engaging component each define one or more
studs sized and shaped to permit the first swivel arm and the
second swivel arm to be coupled thereto.
[0023] In at least one exemplary embodiment of an implantable
restraining device of the present disclosure, the first swivel arm
and the second swivel arm further define one or more curvatures,
whereby the first bend, the second bend, and the one or more
curvatures define a native U-shaped configuration. In an additional
embodiment, the device further comprises a tape positioned around
at least part of the device so that the tape engages the first
interconnection arm and the second interconnection arm. In another
embodiment, the tape is capable of decreasing an interior space
defined between the first engaging component and the second
engaging component when the tape applies a force to the first
interconnection arm and the second interconnection arm. In yet
another embodiment, the tape further comprises one or more
detectable portions positioned/imprinted thereon. In various
embodiments, the one or more detectable portions are
radiopaque.
[0024] In at least one exemplary embodiment of an implantable
restraining device of the present disclosure, the device further
comprises a cover flap, the cover flap coupled to either the first
engaging component or the second engaging component, the cover flap
capable of either further coupling to the second engaging component
when initially coupled to the first engaging component or further
coupling to the first engaging component when initially coupled to
the second engaging component. In another embodiment, the at least
one of the first engaging component and the second engaging
component define one or more suture apertures therethrough. In yet
another embodiment, the first engaging component and the second
engaging component each comprise a proximal end, a distal end, and
a body extending therebetween, wherein the body of the first
engaging component is configured to conform to a first targeted
tissue surface, and the body of the second engaging component is
configured to conform to a second targeted tissue surface.
[0025] In at least one exemplary embodiment of an implantable
restraining device of the present disclosure, the device further
comprises a first adjustment rod and a second adjustment rod, each
of the first adjustment rod and the second adjustment rod
comprising a distal end, a proximal end, and threading
therebetween, and a dial rotatably coupled thereto at or near the
threading. In another embodiment, the first adjustment rod is
coupled to the first swivel arm and the first interconnection arm,
and wherein the second adjustment rod is coupled to the second
swivel arm and the second interconnection arm. In yet another
embodiment, rotation of the dial on either or both of the first
adjustment rod and/or the second adjustment rod facilitates
movement of the first engaging component and the second engaging
component. In an additional embodiment, rotation of the dial in a
first direction causes the first engaging component and the second
engaging component to move toward one another, and wherein rotation
of the dial in a second direction causes the first engaging
component and the second engaging component to move away from one
another.
[0026] In at least one exemplary embodiment of an implantable
restraining device of the present disclosure, each of the first
adjustment rod and the second adjustment rod further comprises a
bar coupled thereto at or near the distal ends of said rods. In an
additional embodiment the bar coupled to the first adjustment rod
is positioned distal to the first interconnection arm, and wherein
the bar coupled to the second adjustment rod is positioned distal
to the second interconnection arm, and wherein rotation of the dial
on either or both of the first adjustment rod and/or the second
adjustment rod facilitates movement of the first engaging component
and the second engaging component. In yet an additional embodiment
each of the first adjustment rod and the second adjustment rod
further comprises a cap coupled thereto at or near the proximal
ends of said rods, said caps configured to prevent said dials from
disengaging said adjustment rods. In another embodiment, said dials
define a dial aperture therethrough, the dial configured to permit
an indicia present upon said adjustment rods to be viewed
therethrough. In yet another embodiment, each of the first engaging
component and the second engaging component define one or more
facets along at least part of a length of said engaging components,
said facets providing a generally arcuate profile of said engaging
components.
[0027] In at least one exemplary embodiment of an implantable
restraining device of the present disclosure, each of the first
engaging component and the second engaging component comprise a
configuration chosen from a straight bar configuration, a curved
configuration, or a circular configuration. In an additional
embodiment, the first engaging component and the second engaging
component are flexible or semi-flexible. In various embodiments,
the first engaging component, the second engaging component, the
first swivel arm, and the second swivel arm each comprise a
material suitable to resist corrosion selected from the group
consisting of polyurethane, polyethylene, polytetrafluoroethylene,
nitinol, silastic, titanium, and stainless steel. In various
embodiments, the first engaging component, the second engaging
component, the first swivel arm, and the second swivel arm comprise
a resorbable material selected from the group consisting of
polyglycolide (PGA), polylactide (PLA), l-lactide (LPLA),
poly(dl-lactide) (DLPLA), poly(c-caprolactone) (PCL),
poly(dioxanone) (PDO), polylglycolide-trimethylene carbonate
(PGA-TMC), or poly(d,l-lactide-co-glycolide) (DLPLG).
[0028] In at least one exemplary embodiment of implantable
restraining device of the present disclosure, the device comprises
a first engaging component defining a first bend and a second
engaging component defining a second bend, the first and second
engaging components configured for laparoscopic insertion into a
body cavity, a first swivel arm and a second swivel arm, the first
swivel arm coupled to the first engaging component at a first pivot
point and coupled to the second engaging component at a second
pivot point, and the second swivel arm coupled to the first
engaging component at a third pivot point and coupled to the second
engaging component at a fourth pivot point, a first interconnection
arm and a second interconnection arm, the first interconnection arm
connected to the first swivel arm relative to the first bend, and
the second interconnection arm connected to the second swivel arm
relative to the second bend, a tape positioned around at least part
of the device so that the tape engages the first interconnection
arm and the second interconnection arm, and a cover flap, the cover
flap coupled to either the first engaging component or the second
engaging component, the cover flap capable of either further
coupling to the second engaging component when initially coupled to
the first engaging component or further coupling to the first
engaging component when initially coupled to the second engaging
component, wherein the first swivel arm and the second swivel arm
are capable of moving between a first position that is
substantially parallel with the first engaging component and the
second engaging component and a second position that is
substantially perpendicular with the first engaging component and
the second engaging component.
[0029] In at least one exemplary embodiment of implantable
restraining device of the present disclosure, the device comprises
a first engaging component and a second engaging component, each
component configured for laparoscopic insertion into a body cavity,
a first swivel arm defining a first bend and a second swivel arm
defining a second bend, the first swivel arm coupled to the first
engaging component at a first pivot point and coupled to the second
engaging component at a second pivot point, and the second swivel
arm coupled to the first engaging component at a third pivot point
and coupled to the second engaging component at a fourth pivot
point, a first interconnection arm and a second interconnection
arm, the first interconnection arm connected to the first swivel
arm relative to the first bend, and the second interconnection arm
connected to the second swivel arm relative to the second bend, a
first adjustment rod and a second adjustment rod, each of the first
adjustment rod and the second adjustment rod comprising a distal
end, a proximal end, and threading therebetween, a dial rotatably
coupled thereto at or near the threading, and a bar coupled thereto
at or near the distal ends of said adjustment rods, wherein the
first adjustment rod is coupled to the first swivel arm and the
first interconnection arm, and wherein the second adjustment rod is
coupled to the second swivel arm and the second interconnection
arm, wherein rotation of the dial in a first direction causes the
first engaging component and the second engaging component to move
toward one another, and wherein rotation of the dial in a second
direction causes the first engaging component and the second
engaging component to move away from one another, and wherein the
first swivel arm and the second swivel arm are capable of moving
between a first position that is substantially parallel with the
first engaging component and the second engaging component and a
second position that is substantially perpendicular with the first
engaging component and the second engaging component.
[0030] In at least one exemplary embodiment of a method for
restoring a targeted tissue of the present disclosure, the method
comprises the steps of inserting an implantable restraining device
into a body cavity of a mammalian body, the implantable restraining
device comprising a first engaging component defining a first bend
and a second engaging component defining a second bend, the first
and second engaging components configured for laparoscopic
insertion into a body cavity, a first swivel arm and a second
swivel arm, the first swivel arm coupled to the first engaging
component at a first pivot point and coupled to the second engaging
component at a second pivot point, and the second swivel arm
coupled to the first engaging component at a third pivot point and
coupled to the second engaging component at a fourth pivot point,
and a first interconnection arm and a second interconnection arm,
the first interconnection arm connected to the first swivel arm
relative to the first bend, and the second interconnection arm
connected to the second swivel arm relative to the second bend,
advancing the implantable restraining device to a location within
the mammalian body adjacent to a targeted tissue, swiveling the
first swivel arm and the second swivel arm so that the first swivel
arm and the second swivel arm are substantially perpendicular to
the first engaging component and the second engaging component, and
positioning the first engaging component and the second engaging
component over the targeted tissue such that at least a portion of
the targeted tissue is positioned therebetween, wherein when the
targeted tissue expands in a direction between the first engaging
component and the second engaging component, the targeted tissue
exerts a force upon the first engaging component and the second
engaging component. In another embodiment, the method further
comprises the step of securing one or more sutures to connect the
first engaging component and/or the second engaging component to
the targeted tissue. In yet another embodiment, the method further
comprises the step of securing a cover flap coupled to either the
first engaging component or the second engaging component so that
the cover flap capable is either further coupled to the second
engaging component when initially coupled to the first engaging
component or further coupled to the first engaging component when
initially coupled to the second engaging component. In an
additional embodiment, the method further comprises the step of
adjusting a tape positioned around at least part of the device
whereby the tape engages the first interconnection arm and the
second interconnection arm, wherein adjustment of the tape
decreases an interior space defined between the first engaging
component and the second engaging component when the tape applies a
force to the first interconnection arm and the second
interconnection arm, and wherein adjustment of the tape increases
an interior space defined between the first engaging component and
the second engaging component when the force is removed or reduced.
In various embodiments, the targeted tissue is a stomach, and
wherein expansion of the stomach, with said device positioned
thereon, functionally divides the stomach into a first stomach
portion and a second stomach portion. In at least another
embodiment, the implantable restraining device further comprises a
first adjustment rod and a second adjustment rod, each of the first
adjustment rod and the second adjustment rod having a dial
rotatably coupled thereto, wherein the first adjustment rod is
coupled to the first swivel arm and the first interconnection arm,
and wherein the second adjustment rod is coupled to the second
swivel arm and the second interconnection arm, and wherein the
method further comprises the step, of rotating said dials to adjust
an interior space between the first engaging component and the
second engaging component.
[0031] In at least one exemplary embodiment of an implantable
restraining device of the present disclosure, the device comprises
a first engaging component and a second engaging component at least
substantially parallel to one another, a first swivel arm,
comprising a first fixed arm, a first expandable arm, and a first
hub, wherein the first fixed arm is pivotally connected to the
first engaging component at or near a first fixed arm first end and
is coupled to the first hub at or near a first fixed arm second
end, and wherein the first expandable arm is pivotally connected to
the second engaging component at or near a first expandable arm
first end and is connected to the first hub at or near a first
expandable arm second end by way of a first hub bracket, a second
swivel arm, comprising a second fixed arm, a second expandable arm,
and a second hub, wherein the second fixed arm is pivotally
connected to the first engaging component at or near a second fixed
arm first end and is coupled to the second hub at or near a second
fixed arm second end, and wherein the second expandable arm is
pivotally connected to the second engaging component at or near a
second expandable arm first end and is connected to the second hub
at or near a second expandable arm second end by way of a second
hub bracket, and wherein the first expandable arm and the second
expandable are capable of movement relative to the first hub and
the second hub respectively so that a distance between the first
engaging component and the second engaging component may change
relative to movement of the first expandable arm and the second
expandable arm. In another embodiment, the first swivel arm is
capable of rotation in a first direction, and wherein the second
swivel arm is capable of rotation in an opposing second direction.
In yet another embodiment, the first swivel arm and the second
swivel arm are capable of rotation so that the first swivel arm,
the second swivel arm, the first engaging component, and the second
engaging component share a common linear axis. In an additional
embodiment, the first swivel arm and the second swivel arm are
capable of rotation so that the first swivel arm and the second
swivel arm are substantially or fully perpendicular to the first
engaging component and the second engaging component. In yet an
additional embodiment, the first fixed arm is relatively shorter
than the second fixed arm, and wherein the first expandable arm is
relatively shorter than the second expandable arm.
[0032] In at least one exemplary embodiment of an implantable
restraining device of the present disclosure, the device further
comprises a first arm flange at or near the first expandable arm
second end, the first arm flange configured to limit expansion of
the first expandable arm relative to the first fixed arm, and a
second arm flange at or near the second expandable arm second end,
the second arm flange configured to limit expansion of the second
expandable arm relative to the second fixed arm. In an additional
embodiment, the device is sized and shaped to fit within a
laparoscopic bodily port.
[0033] In at least one exemplary embodiment of an implantable
restraining device of the present disclosure, the device further
comprises a first strap positioned at a first end of the first
engaging component and at a first end of the second engaging
component, the first strap configured to limit movement of the
first engaging component and the second engaging component when the
first strap is coupled to the first engaging component and the
second engaging component. In an additional embodiment, the first
strap is fixedly coupled to one of the first end of the first
engaging component or the first end of the second engaging
component. In yet an additional embodiment, the first strap is
coupled to one of the first end of the first engaging component or
the first end of the second engaging component by way of at least
one suture. In another embodiment, the first strap has at least one
suture aperture defined therethrough, and wherein at least one of
the first engaging component and the second engaging component has
at least one plate aperture defined therethrough, the at least one
suture aperture and the at least one plate aperture configured to
permit a suture to be placed therethrough to couple the first strap
to either the first engaging component or the second engaging
component.
[0034] In at least one exemplary embodiment of an implantable
restraining device of the present disclosure, the device further
comprises a first pad coupled to one or both of the first fixed arm
and the first expandable arm, and a second pad coupled to one or
both of the second fixed arm and the second expandable arm, wherein
the first pad and the second pad are configured to engage at least
a portion of a mammalian bodily organ positioned therebetween. In
another embodiment, the first engaging component and the second
engaging component are configured to engage a targeted tissue
therebetween when the first swivel arm and the second swivel arm
are in a configuration relatively perpendicular to the first
engaging component and the second engaging component. In yet
another embodiment, the first engaging component, the second
engaging component, the first swivel arm, and the second swivel arm
each comprise a material suitable to resist corrosion selected from
the group consisting of polyurethane, polyethylene,
polytetrafluoroethylene, polyaryletherketone, carbothane,
tecothane, nitinol, silastic, titanium, and stainless steel.
[0035] In at least one exemplary embodiment of an implantable
restraining device of the present disclosure, each of the first
engaging component and the second engaging component define one or
more facets along at least part of a length of said engaging
components, said facets providing a generally arcuate profile of
said engaging components. In an additional embodiment, each of the
first engaging component and the second engaging component comprise
a configuration chosen from a straight bar configuration, a curved
configuration, or a circular configuration. In yet an additional
embodiment, the first engaging component and the second engaging
component are flexible or semi-flexible.
[0036] In at least one exemplary embodiment of an implantable
restraining device of the present disclosure, the device comprises
a first engaging component and a second engaging component at least
substantially parallel to one another, a first swivel arm,
comprising a first fixed arm, a first expandable arm, and a first
hub, wherein the first fixed arm is pivotally connected to the
first engaging component at or near a first fixed arm first end and
is coupled to the first hub at or near a first fixed arm second
end, and wherein the first expandable arm is pivotally connected to
the second engaging component at or near a first expandable arm
first end and is connected to the first hub at or near a first
expandable arm second end by way of a first hub bracket, a second
swivel arm, comprising a second fixed arm, a second expandable arm,
and a second hub, wherein the second fixed arm is pivotally
connected to the first engaging component at or near a second fixed
arm first end and is coupled to the second hub at or near a second
fixed arm second end, and wherein the second expandable arm is
pivotally connected to the second engaging component at or near a
second expandable arm first end and is connected to the second hub
at or near a second expandable arm second end by way of a second
hub bracket, and a first strap positioned at one or both of a first
end of the first engaging component and at a first end of the
second engaging component, the first strap configured to limit
movement of the first engaging component and the second engaging
component when the first strap is coupled to the first engaging
component and the second engaging component. wherein the first
expandable arm and the second expandable are capable of movement
relative to the first hub and the second hub respectively so that a
distance between the first engaging component and the second
engaging component may change relative to movement of the first
expandable arm and the second expandable arm, and wherein the first
swivel arm is capable of rotation in a first direction so that the
first swivel arm, the second swivel arm, the first engaging
component, and the second engaging component share a common linear
axis, and wherein the second swivel arm is capable of rotation in
an opposing second direction so that the first swivel arm and the
second swivel arm are substantially or fully perpendicular to the
first engaging component and the second engaging component.
[0037] In at least one embodiment of a method for restoring a
targeted tissue of the present disclosure, the method comprises the
steps of inserting an implantable restraining device into a body
cavity of a mammalian body, the implantable restraining device
comprising a first engaging component and a second engaging
component at least substantially parallel to one another, a first
swivel arm, comprising a first fixed arm, a first expandable arm,
and a first hub, wherein the first fixed arm is pivotally connected
to the first engaging component at or near a first fixed arm first
end and is coupled to the first hub at or near a first fixed arm
second end, and wherein the first expandable arm is pivotally
connected to the second engaging component at or near a first
expandable arm first end and is connected to the first hub at or
near a first expandable arm second end by way of a first hub
bracket, a second swivel arm, comprising a second fixed arm, a
second expandable arm, and a second hub, wherein the second fixed
arm is pivotally connected to the first engaging component at or
near a second fixed arm first end and is coupled to the second hub
at or near a second fixed arm second end, and wherein the second
expandable arm is pivotally connected to the second engaging
component at or near a second expandable arm first end and is
connected to the second hub at or near a second expandable arm
second end by way of a second hub bracket, advancing the
implantable restraining device to a location within the mammalian
body adjacent to a targeted tissue, swiveling the first swivel arm
and the second swivel arm so that the first swivel arm and the
second swivel arm are substantially perpendicular to the first
engaging component and the second engaging component, and
positioning the first engaging component and the second engaging
component over the targeted tissue such that at least a portion of
the targeted tissue is positioned therebetween, wherein when the
targeted tissue expands in a direction between the first engaging
component and the second engaging component, the targeted tissue
exerts a force upon the first engaging component and the second
engaging component so that the first expandable arm moves relative
to the first hub and so that the second expandable arm moves
relative to the second hub. In another embodiment, the targeted
tissue is a stomach, and wherein expansion of the stomach, with
said device positioned thereon, functionally divides the stomach
into a first stomach portion and a second stomach portion.
[0038] In at least one embodiment of an implantable device of the
present disclosure, the implantable device comprises a first
engaging component comprising a first rigid inner plate at least
partially surrounded by a first flexible coating, a second engaging
component comprising a second rigid inner plate at least partially
surrounded by a coating selected from the group consisting of the
first flexible coating and the second flexible coating, a first
c-ring and a second c-ring, the first c-ring coupled to the first
engaging component at a first pivot point and coupled to the second
engaging component at a second pivot point, and the second c-ring
coupled to the first engaging component at a third pivot point and
coupled to the second engaging component at a fourth pivot point,
and a cover flap, the cover flap coupled to either the first
engaging component or the second engaging component, the cover flap
capable of either further coupling to the second engaging component
when initially coupled to the first engaging component or further
coupling to the first engaging component when initially coupled to
the second engaging component, wherein each of the first engaging
component and the second engaging component define a longitudinal
axis, wherein the device is further configured for placement around
at least part of a stomach, and wherein the first c-ring and the
second c-ring are configured to move from a first position that is
substantially coplanar with the first engaging component and the
second engaging component to a second position that is
substantially perpendicular with the first engaging component and
the second engaging component so to open the device, said movement
in a plane perpendicular to a plane defined by an interior space
between the first engaging component and the second engaging
component. In an additional embodiment, when the first c-ring and
the second c-ring are not positioned within the interior space
between the first engaging component and the second engaging
component when in the second position when the device is open. In
yet an additional embodiment, the first flexible coating extends
beyond a perimeter of the first rigid plate and wherein the second
flexible coating extends beyond a perimeter of the second rigid
plate. In an additional embodiment, when the first flexible coating
extends beyond a perimeter of the first rigid plate and when the
second flexible coating extends beyond a perimeter of the second
rigid plate, the first flexible coating and the second flexible
coating prevents shearing and migration of the device when the
first engaging component and the second engaging component contact
the stomach.
[0039] In at least one embodiment of an implantable device of the
present disclosure, the device further comprises a first swivel
stop positioned along at least one of the first engaging component
and the second engaging component, the first swivel stop configured
to limit swiveling of the first c-ring, and a second swivel stop
positioned along at least one of the first engaging component and
the second engaging component, the second swivel stop configured to
limit swiveling of the second c-ring. In an additional embodiment,
at least one of the first c-ring and the second c-ring comprises at
least one suture feature. In yet an additional embodiment, the
cover flap comprises a first material surrounded at least
substantially by a coating selected from the group consisting of
the first flexible coating, the second flexible coating, and a
third coating. In an additional embodiment, at least one tab
aperture is defined within the cover flap, wherein one of the first
engaging component and the second engaging component further
comprises a tab, and wherein the tab is configured for insertion
into the tab aperture. In yet an additional embodiment, one of the
first engaging component and the second engaging component further
comprises a loop coupled thereto, wherein at least a portion of the
cover flap is configured to fit within the loop.
[0040] In at least one embodiment of an implantable device of the
present disclosure, one of the first engaging component and the
second engaging component comprises a component tab configured to
fit within a tab receiver of at the other of the first engaging
component and the second engaging component. In an additional
embodiment, at least one of the first c-ring and the second c-ring
comprises a first c-ring portion and a second c-ring portion. In
yet an additional embodiment, the first c-ring portion and the
second c-ring portion are coupled to one another by a coupler
positioned at a pivot point. In an additional embodiment, the first
c-ring portion and the second c-ring portion are configured to
pivot about one another at the pivot point. In yet an additional
embodiment, one of the first c-ring portion and the second c-ring
portion comprises a post, wherein the other of the first c-ring
portion and the second c-ring portion has a post aperture defined
therein, and wherein the post aperture is configured to receive the
post.
[0041] In at least one embodiment of an implantable device of the
present disclosure, the first c-ring portion and the second c-ring
portion are configured to move relative to one another when the
post moves relative to the post aperture. In an additional
embodiment, the first c-ring portion and the second c-ring portion
are coupled to one another by a slider coupler coupled to one of
the first c-ring portion and the second c-ring portion. In yet an
additional embodiment, an engagement mechanism of one of the first
c-ring portion and the second c-ring portion is configured to
engage the slider coupler. In an additional embodiment, one of the
first c-ring portion and the second c-ring portion comprises a
joiner defining an inner threaded portion, wherein the other of the
first c-ring portion and the second c-ring portion has an outer
threaded portion, and wherein the inner threaded portion is
configured to receive the outer threaded portion. In yet an
additional embodiment, one of the first c-ring portion and the
second c-ring portion comprises a c-ring stub, wherein the other of
the first c-ring portion and the second c-ring portion has a post
c-ring stub aperture defined therein, and wherein the c-ring stub
aperture is configured to receive the c-ring stub.
[0042] In at least one embodiment of an implantable device of the
present disclosure, the first c-ring portion and the second c-ring
portion are configured to move relative to one another when the
c-ring stub moves relative to the c-ring stub aperture. In an
additional embodiment, the device further comprises a cover
positioned around a portion of the first c-ring and the second
c-ring at or near the c-ring stub. In yet an additional embodiment,
the first c-ring portion and the second c-ring portion are coupled
to one another by hinge coupled to the first c-ring portion and the
second c-ring portion. In an additional embodiment, the first
c-ring portion and the second c-ring portion can move relative to
one another and relative to the hinge by way of at least two pivot
points. In yet an additional embodiment, at least one of the first
c-ring and the second c-ring comprises or is coupled to an
elongated coupler having at least one living hinge defined
therein.
[0043] In at least one embodiment of an implantable device of the
present disclosure, the elongated coupler is configured to bend at
he at least one living hinge. In an additional embodiment, the
elongated coupler is configured to connect to a portion of a second
elongated coupler coupled to the first c-ring or the second c-ring
that is not coupled to the elongated coupler. In yet an additional
embodiment, at least one of the first c-ring and the second c-ring
comprises a metal insert at least substantially surrounded by a
coating selected from the group consisting of the first flexible
coating, the second flexible coating, and a third coating. In an
additional embodiment, the first engaging component and the second
engaging component are configured to engage a targeted tissue
therebetween when the first c-ring and the second c-ring are in a
configuration relatively perpendicular to the first engaging
component and the second engaging component. In yet an additional
embodiment, at least one of the first engaging component and the
second engaging component define one or more suture apertures
therethrough.
[0044] In at least one embodiment of an implantable device of the
present disclosure, the first engaging component and the second
engaging component each comprise a proximal end, a distal end, and
a body extending therebetween, wherein the body of the first
engaging component is configured to conform to a first targeted
tissue surface, and the body of the second engaging component is
configured to conform to a second targeted tissue surface. In an
additional embodiment, each of the first engaging component and the
second engaging component define one or more facets along at least
part of a length of said engaging components, said facets providing
a generally arcuate profile of said engaging components. In yet an
additional embodiment, each of the first engaging component and the
second engaging component comprise a configuration chosen from a
straight bar configuration, a curved configuration, or a circular
configuration. In an additional embodiment, the first engaging
component and the second engaging component are flexible or
semi-flexible. In yet an additional embodiment, the first engaging
component, the second engaging component, the first c-ring, and the
second c-ring each comprise a material suitable to resist corrosion
selected from the group consisting of polyurethane, polyethylene,
polytetrafluoroethylene, nitinol, silastic, titanium, and stainless
steel.
[0045] In at least one embodiment of an implantable device of the
present disclosure, the first engaging component, the second
engaging component, the first c-ring, and the second c-ring
comprise a resorbable material selected from the group consisting
of polyglycolide (PGA), polylactide (PLA), l-lactide (LPLA),
poly(dl-lactide) (DLPLA), poly(.epsilon.-caprolactone) (PCL),
poly(dioxanone) (PDO), polylglycolide-trimethylene carbonate
(PGA-TMC), or poly(d,l-lactide-co-glycolide) (DLPLG). In an
additional embodiment, the device is configured for laparascopic
insertion into a body cavity.
[0046] In at least one embodiment of method for using an
implantable device of the present disclosure, the method comprising
the steps of inserting an implantable device into a mammalian body,
the implantable device comprising a first engaging component
comprising a first rigid inner plate at least partially surrounded
by a first flexible coating, a second engaging component comprising
a second rigid inner plate at least partially surrounded by a
coating selected from the group consisting of the first flexible
coating and the second flexible coating, a first c-ring and a
second c-ring, the first c-ring coupled to the first engaging
component at a first pivot point and coupled to the second engaging
component at a second pivot point, and the second c-ring coupled to
the first engaging component at a third pivot point and coupled to
the second engaging component at a fourth pivot point, and a cover
flap, the cover flap coupled to either the first engaging component
or the second engaging component, the cover flap capable of either
further coupling to the second engaging component when initially
coupled to the first engaging component or further coupling to the
first engaging component when initially coupled to the second
engaging component, wherein each of the first engaging component
and the second engaging component define a longitudinal axis,
advancing the implantable device to a location within the mammalian
body adjacent to a targeted tissue, swiveling the first c-ring and
the second c-ring so that the first c-ring and the second c-ring
are substantially perpendicular to the first engaging component and
the second engaging component, and positioning the first engaging
component and the second engaging component over the targeted
tissue such that at least a portion of the targeted tissue is
positioned therebetween. In another embodiment, when the targeted
tissue expands in a direction between the first engaging component
and the second engaging component, the targeted tissue exerts a
force upon the first engaging component and the second engaging
component. In yet another embodiment, the step of inserting is
performed laparoscopically. In an additional embodiment, the step
of inserting is performed surgically.
[0047] In at least one embodiment of method for using an
implantable device of the present disclosure, the step of
positioning is performed to position the first engaging component
and the second engaging component over at least part of a stomach.
In an additional embodiment, the method is performed to treat an
obese patient. In yet an additional embodiment, the method is
performed so that a patient using the implantable device can
achieve satiety faster than if the implantable device was not used.
In another embodiment, the method is performed to reduce a
potential amount of food intake by reducing or eliminating an
amount of food that can enter a fundus of the stomach. In yet
another embodiment, the step of swiveling is performed to move the
first c-ring and the second c-ring from a first position that is
substantially coplanar with the first engaging component and the
second engaging component to a second position that is
substantially perpendicular with the first engaging component and
the second engaging component so to open the implantable device,
said movement in a plane perpendicular to a plane defined by an
interior space between the first engaging component and the second
engaging component.
[0048] In at least one embodiment of method for using an
implantable device of the present disclosure, the method further
comprises the step of securing one or more sutures to connect the
first engaging component and/or the second engaging component to
the targeted tissue. In another embodiment, the method further
comprises the step of securing the cover flap so that the cover
flap is secured to the first engaging component and the second
engaging component. In yet another embodiment, wherein the targeted
tissue is a stomach, and wherein expansion of the stomach, with
said device positioned thereon, functionally divides the stomach
into a first stomach portion and a second stomach portion. In an
additional embodiment, the method further comprises the step of
securing the cover flap over a fundus of the stomach so that the
cover flap is secured to the first engaging component and the
second engaging component.
BRIEF DESCRIPTION OF THE DRAWINGS
[0049] FIGS. 1 and 2 show perspective views of at least one
embodiment of a restraining device for restoring and/or supporting
a tissue or organ of the present disclosure;
[0050] FIG. 3A shows a top view of at least one embodiment of a
restraining device for restoring and/or supporting a tissue or
organ according to the present disclosure;
[0051] FIGS. 3B through 3E show various embodiments of engaging
components according to the present disclosure;
[0052] FIG. 4A shows a side view of the restraining device of FIGS.
lA and 1B applied in a longitudinal fashion to a stomach according
to the present disclosure;
[0053] FIG. 4B shows a cross-sectional view of a restored stomach
along line A-A of FIG. 4;
[0054] FIGS. 5A through 5D show various embodiments of restraining
devices positioned about a stomach according to the present
disclosure;
[0055] FIG. 6 shows a flow chart of a method for laparoscopically
delivering embodiments of the restraining device disclosed herein
to a targeted tissue according to the present disclosure;
[0056] FIGS. 7A, 7B, and 8 show various embodiments of a
restraining device comprising one or more struts according to the
present disclosure;
[0057] FIG. 9 shows an exemplary embodiment of a restraining device
comprising two springs and a mesh curtain according to the present
disclosure;
[0058] FIG. 10 shows an exemplary embodiment of a restraining
device comprising a pliable junction according to the present
disclosure;
[0059] FIG. 11 shows a restraining device positioned within a
laparoscopic port according to the present disclosure;
[0060] FIGS. 12A, 12B, 13A, and 13B show various embodiments of a
restraining device comprising a coupler according to the present
disclosure;
[0061] FIGS. 14A and 14B show exemplary embodiments of a
restraining device comprising a coupler and a coupler pivot
according to the present disclosure;
[0062] FIGS. 15A and 15B show exemplary embodiments of an apparatus
for delivering a restraining device according to the present
disclosure;
[0063] FIGS. 16A and 16B show exemplary embodiments of an apparatus
for delivering a restraining device comprising a coupler according
to the present disclosure;
[0064] FIGS. 17A and 17B show additional exemplary embodiments of
an apparatus for delivering a restraining device according to the
present disclosure;
[0065] FIG. 18 shows an exemplary embodiment of an apparatus
perpendicularly engaging a restraining device according to the
present disclosure;
[0066] FIG. 19 shows a flow chart of a method for laparoscopically
removing embodiments of the restraining device disclosed herein
from a targeted tissue according to the present disclosure;
[0067] FIG. 20 shows a perspective view of at least another
embodiment of a restraining device for restoring and/or supporting
a tissue or organ of the present disclosure;
[0068] FIG. 21 shows an exemplary embodiment of a restraining
device positioned about a stomach according to the present
disclosure;
[0069] FIG. 22 shows steps of an exemplary method of inserting,
delivering, and placing a restraining device about a targeted
tissue according to the present disclosure;
[0070] FIG. 23 shows a perspective view of at least another
embodiment of a restraining device for restoring and/or supporting
a tissue or organ of the present disclosure;
[0071] FIG. 24 shows a side view of the embodiment of a restraining
device shown in FIG. 23;
[0072] FIG. 25 shows a perspective view of an embodiment of an
adjustment rod of the present disclosure;
[0073] FIG. 26 shows a side view of the embodiment of an adjustment
rod shown in FIG. 25;
[0074] FIG. 27 shows a side view of an embodiment of an adjustment
rod coupled to at least another component of an exemplary
restraining device of the present disclosure;
[0075] FIG. 28 shows another perspective view of the embodiment of
a restraining device shown in FIG. 23;
[0076] FIG. 29 shows steps of another exemplary method of
inserting, delivering, and placing a restraining device about a
targeted tissue according to the present disclosure;
[0077] FIG. 30 shows a perspective view of an exemplary embodiment
of a restraining device of the present disclosure in a relatively
open configuration;
[0078] FIG. 31 shows a perspective view of an exemplary embodiment
of a restraining device of the present disclosure in a relatively
open configuration;
[0079] FIGS. 32 and 33 show top views of an exemplary embodiment of
a restraining device of the present disclosure;
[0080] FIG. 34 shows a side view of an exemplary embodiment of a
restraining device of the present disclosure in a relatively closed
configuration;
[0081] FIG. 35 shows a perspective view of an exemplary embodiment
of a restraining device of the present disclosure in a relatively
closed configuration;
[0082] FIG. 36 shows a side view of an exemplary swivel arm of the
present disclosure;
[0083] FIG. 37 shows a perspective view of an exemplary swivel arm
of the present disclosure;
[0084] FIG. 38 shows a side view of another exemplary swivel arm of
the present disclosure;
[0085] FIG. 39 shows a perspective view of another exemplary swivel
arm of the present disclosure;
[0086] FIGS. 40, 41, and 42 show exemplary embodiments of
restraining devices of the present disclosure positioned about a
stomach; and
[0087] FIGS. 43 and 44 show perspective views of devices, according
to exemplary embodiments of the present disclosure;
[0088] FIGS. 45A, 45B, and 45C show portions of straps, according
to exemplary embodiments of the present disclosure;
[0089] FIG. 46 shows portions of engaging components and a strap,
according to an exemplary embodiment of the present disclosure;
[0090] FIGS. 47A-52B show first and second c-ring portions coupled
to or configured for coupling to each other, according to exemplary
embodiments of the present disclosure;
[0091] FIGS. 53A and 53B show a first elongated coupler and a first
elongated coupler coupled to a second elongated coupler,
respectively, according to exemplary embodiments of the present
disclosure;
[0092] FIG. 54 shows a perspective view of a device, according to
an exemplary embodiment of the present disclosure; and
[0093] FIGS. 55A and 55B show cross-sectional views of exemplary
engaging components, according to exemplary embodiments of the
present disclosure.
DETAILED DESCRIPTION
[0094] For the purposes of promoting an understanding of the
principles of the present disclosure, reference will now be made to
the embodiments illustrated in the drawings, and specific language
will be used to describe the same. It will nevertheless be
understood that no limitation of the scope of this disclosure is
thereby intended.
[0095] FIGS. 1 and 2 show perspective views of at least one
embodiment of a restraining device 10 for restoring a tissue or
organ. In at least one embodiment of the restraining device 10, the
restraining device 10 comprises an implantable device and does not
require substantial sutures, staples or pins to be secured on the
targeted tissue or organ of interest. Further, the restraining
device 10 described herein is configured to loosely, albeit
securely, engage to the targeted tissue such that the underlying
tissue is either uncompressed or only loosely compressed. The
various embodiments of the restraining device 10 described herein
may be available for temporary or chronic placement within a
patient's body, and the restoration procedures performed through
the use of an exemplary device 10 are reversible through minimally
invasive procedures.
[0096] As shown in FIGS. 1 and 2, at least one embodiment of the
restraining device 10 comprises a first engaging component 12 and a
second engaging component 16. The first engaging component 12 may
comprise a first shape and the second engaging component 16 may
comprise a second shape that corresponds to at least a portion of
the first shape of the first engaging component 12. For example,
and without limitation, the first and second engaging components
12, 16 may be configured in a bar configuration as shown in FIGS. 1
and 2. Alternatively, the first and second engaging components 12,
16 may be configured in a contoured, circular or any other
configuration suitable for use as referenced herein. Additionally,
the first and second engaging components 12, 16 may be configured
such that the shape of each of the components 12, 16 defines an
interior area (not shown). It will be understood that the first and
second engaging components 12, 16 of an exemplary restraining
device 10 may be configured in any shape and may also be flexible,
semi-flexible, or articulated. Furthermore, it is contemplated that
a clinician may select the desired configuration of the components
12, 16 of the restraining device 10 based on the particular patient
to be treated and/or pursuant to the specific application for which
the restraining device 10 will be used to ensure that the
restraining device 10 appropriately conforms to the tissue or organ
of interest. For example, an exemplary embodiment of a restraining
device 10 of the present disclosure may comprise first and second
engaging components 12, 16 having a width of approximately 14 mm
and a length of approximately 120 mm. In at least one additional
embodiment, the first and second engaging components 12, 16 may
have a width between 5 mm and 15 mm, and may have a length between
30 mm and 200 mm, with any number of potential widths and lengths
contemplated by the present disclosure suitable for use with an
exemplary restraining device 10 of the present disclosure.
[0097] In at least one embodiment of a restraining device 10 of the
present disclosure, and as shown in FIG. 2, the first engaging
component 12 of the restraining device 10 comprises a proximal end
13, a body having a first side 12A and a second side 12B, and a
distal end 14. The first side 12A of the first engaging component
12 is configured to be positioned adjacent to or in contact with a
tissue or organ of interest. Likewise, the second engaging
component 16 comprises a proximal end 17, a body having a first
side 16A and a second side 16B, and a distal end 18. The first side
16A of the second engaging component 16 is configured to be
positioned adjacent to or in contact with the tissue or organ of
interest.
[0098] The first engaging component 12 and the second engaging
component 16 each comprise a material suitable to resist corrosion,
such as and without limitation polyurethane, polyethylene,
polytetrafluoroethylene ("PTFE"), nitinol, silastic, titanium,
stainless steel or any other material suitable for use in the
medical arts that is corrosion resistant. Accordingly, the
restraining device 10 can withstand chronic placement within a body
without the risk of deterioration. In at least one embodiment, the
first and second engaging components 12, 16 of the restraining
device 10 are comprised of ultra high density polyethylene.
[0099] The first and second engaging components 12, 16 of the
restraining device 10 may be coupled to one or more springs 22,
wherein the one or more springs 22 engage the first and second
engaging components 12, 16 at their distal ends 14, 18 and proximal
ends 13, 17. Springs 22, as well as struts 700 (as shown in FIGS.
7A and 7B) and couplers 1200 (as shown in FIGS. 14A through 16B),
as referenced herein, may be generally referred to as
"connector(s)" as they connect, in various embodiments, first
engaging components 12 and second engaging components 16 of various
restraining devices 10 of the present disclosure. The springs 22
may comprise torsion springs or any other type of spring known or
developed that is capable of supporting the first and second
engaging components 12, 16 a prescribed distance apart from each
other, which may vary depending upon the orientation of the springs
22 about the first and second engaging components 12, 16. As
described in more detail herein, due to the configuration and
resistance of the springs 22, the first and second engaging
components 12, 16 of the restraining device may be held such that
little or no space is defined between the first sides 12A, 16A of
the first and second engaging components 12, 16 based upon a first
orientation of springs 22, and the first and second engaging
components 12, 16 of the restraining device 10 may be held such
that an interior space 70 is defined between the first sides 12A,
16A of the first and second engaging components 12, 16 based upon a
second orientation of springs 22.
[0100] Further, each of the one or more springs 22 may have any
number of coils configured in any fashion, provided the spring
configuration and stiffness are suitable for the desired
application of the restraining device 10. For example, and without
limitation, in at least one embodiment each of the one or more
springs 22 comprises a torsion, resistance spring having three (3)
closely-coiled coils. It will be appreciated that, in practice, a
clinician may alter the number of coils and/or configuration of
each spring 22 to achieve to a desired flexibility or rigidity of
the springs 22 and, in this manner, the restraining device 10 may
be customized for a particular patient and/or application for which
the restraining device 10 is to be applied.
[0101] Each of the springs 22 of the restraining device 10 may
comprise at least one rod 24 extending from each of the ends of its
coils. The length of each rod 24 may be selected depending on the
particular application for which the restraining device 10 is to be
applied. As shown in the exemplary embodiments of a restraining
device 10 in FIGS. 1 and 2, each rod 24 is coupled with either the
first or second engaging component 12, 16. For example, as shown in
FIG. 2, the first rod 24 of one of the springs 22 may be coupled
with the second side 12B of the first engaging component 12 at or
near a location on the distal end 14 of the first engaging
component 12, and the second rod 24 of the same spring 22 may be
coupled with the second side 16B of the second engaging component
16 at or near a location on the distal end 18 of the second
engaging component 16. Furthermore, the rods 24 facilitate the
formation of the interior space 70 (as shown in FIG. 2) between the
first and second engaging components 12, 16 by holding the first
and second engaging components 12, 16 in accordance with the
tension of the springs 22.
[0102] The springs 22 of the restraining device 10 may comprise any
dimensions so long as the restraining device 10 is of a sufficient
size to move through a laparoscopic port and the springs 22 are
capable of holding the first side 12A of the first engaging
component 12 and the second side 16A of the second engaging
component 16 a distance apart when the restraining device 10 has a
configuration whereby the springs 22 are positioned about the first
and second engaging components 12, 16. For example, springs 22 may
have a "first" configuration as shown in FIG. 1, whereby springs 22
and the first and second engaging components 12, 16 are oriented in
the same or substantially the same direction/plane so that the
restraining device 10 may pass through a laparoscopic port. In such
a first configuration, springs 22 engage the first and second
engaging components 12, 16 so that the first and second engaging
components 12, 16 either engage one another or have a relatively
small space between them. Springs 22 may have a "second"
configuration, for example and as shown in FIG. 2, when springs 22
are rotated about first and second engaging components 12, 16 and
are not in the same direction/plane as the configuration of
restraining device shown in FIG. 1. In such a second configuration,
the first and second engaging components 12, 16 may define an
interior space 70 when the restraining device 10 is "at rest," with
the interior space 70 increasing upon positioning the restraining
device 10 around a stomach 100 (as shown in FIGS. 4A through 5A)
for example, and potentially increasing only slightly further upon
introduction of food, for example, into the stomach 100.
[0103] Accordingly, the dimensions of the springs 22 may dictate
the native value of the interior space 70 between the first and
second engaging components 12, 16. In at least one embodiment, the
springs 22 may comprise a maximum outside diameter that is less
than about 14 millimeters to allow a "collapsed" or "compressed"
restraining device 10 to pass within a 15 mm diameter abdominal
port. Furthermore, each of the springs 22 may comprise any material
having a strength that is consonant with the application for which
the restraining device 10 will be employed. In at least one
embodiment, the springs 22 are comprised of a rigid or semi-rigid
material that is suitable to resist corrosion, such as and without
limitation, polyurethane, PTFE, nitinol, silastic, titanium,
stainless steel or any other material suitable for use in the
medical arts that is corrosion resistant.
[0104] Referring back to FIG. 2, and as previously described, the
springs 22 of the restraining device 10 are biased to maintain the
first and second engaging components 12, 16 at a prescribed
distance apart under a native, and as described above, "second"
configuration. In this manner, when no pressure is applied to an
exemplary restraining device 10--or when the restraining device 10
is "at rest"--the interior space 70 having a prescribed value is
formed between the first and second engaging components 12, 16. The
value of the interior space 70 may, in at least one embodiment,
correlate with the outside diameter of the springs 22, minus the
thickness of the first and second engaging components 12, 16. It
will be understood that the value of the interior space 70 can be
manipulated by a clinician depending on the thickness of tissue
and/or organ to be treated or other factors. For example, to
achieve an interior space 70 having a larger prescribed value, the
outer diameter of the spring 22 may be increased and/or the
thickness of the first and/or second engaging components 12, 16 may
be adjusted. Accordingly, a clinician can easily modify the
restraining device 10 such that it may be optimally configured for
a particular application on a particular tissue.
[0105] Due to the nature of the springs 22 (depending on the
material and rigidity selected), the first and second engaging
components 12, 16 may exhibit some degree of "give" such that the
first and second engaging components 12, 16 are capable of moving
relative to each other when pressure is applied. While the first
and second engaging components 12, 16 are biased to return to their
resting position such that the interior space 70 is substantially
equivalent to its prescribed/native value when no pressure is
applied to the springs 22, the springs 22 of the restraining device
10 are also capable of allowing the first and second engaging
components 12, 16 to move in response to force applied thereto. For
example, and without limitation, if a force is applied against the
first sides 12A, 16A of the first and second engaging components
12, 16, this force is translated to the springs 22 which enables
the components 12, 16 of the restraining device 10 to move apart
such that the interior space 70 is increased. Furthermore, if a
force is applied directly to the springs 22 such that the coils are
twisted about their axis in a direction counter to the coil
configuration, similar to the above-listed example, the resultant
effect on the restraining device 10 is that the first and second
engaging components 12, 16 are moved apart and the interior space
70 is increased. However, due to the inherent bias provided by the
springs 22 of the restraining device 10, after the pressure
affecting the springs 22 is released, the springs 22--and thus the
components 12, 16--return to their resting positions such that the
interior space 70 reverts to its original prescribed value. It will
be appreciated that the specific configuration and/or materials
comprising each of the springs 22 may be selected to achieve the
desired degree of elasticity depending on the application for which
the restraining device 10 is to be applied.
[0106] As shown in FIG. 2, each rod 24 of spring 22 is rotatably
coupled with the relevant component 12, 16 of the restraining
device 10 such that each of the rods 24 is capable of pivotal
movement with respect to the relevant component 12, 16 of the
restraining device 10. The rotational coupling of the rods 24 with
the first and second engaging components 12, 16 may be achieved
through any means known in the art. For example and without
limitation, the end of each rod 24 may comprise a pin that is
capable of insertion into and rotation within a hole formed within
the respective second side 12B, 16B of the applicable component 12,
16.
[0107] As each of the rods 24 is coupled with a spring 22, when the
rods 24 rotate with respect to the components 12, 16, this
effectively enables the respective spring 22 to move in an orbital
manner with respect to the proximal or distal end of the
restraining device 10. Accordingly, the springs 22 are capable of
rotating between a position that is substantially parallel with the
first and second engaging components 12, 16 (as shown in FIG. 1,
referred to as a "first" configuration herein) and a position that
is substantially perpendicular to the first and second engaging
components 12, 16 (as shown in FIG. 2, referred to as a "second"
configuration).
[0108] The position of the springs 22 relative to the first and
second engaging components 12, 16 has the potential to
significantly affect the overall width of the restraining device
10. For example and without limitation, when the springs 22 are
positioned in the substantially perpendicular position (i.e., a
"second" configuration), the restraining device 10 may have a width
that is more than twice the width of the same restraining device 10
when its springs 22 are positioned in the substantially parallel
position. Accordingly, the rotational coupling of the rods 24 with
the first and second engaging components 12, 16 provides a
clinician with the ability to manipulate the overall width of the
restraining device 10 during laparoscopic delivery and/or
implantation and further enables the restraining device 10 to be
applied to tissues and/or organs having a length that is longer
than the length of the restraining device 10 (as the proximal ends
13, 17 and the distal ends 14,18 of the first and second engaging
components 12, 16 of the restraining device 10 are not obstructed
by the springs 22). In at least one embodiment, the widest part of
the restraining device 10 is less than about 15 millimeters when
the springs 22 are in the substantially parallel position such that
the restraining device 10 can be easily inserted into a body cavity
through a 15 millimeter trocar or port.
[0109] Now referring to FIG. 3A, a top view of at least one
embodiment of a restraining device 10 of the present disclosure is
shown. Here, the first and/or second engaging components 12, 16 of
the restraining device 10 further comprise one or more pads 30
extending therefrom. As shown in FIG. 3A, the one or more pads 30
may extend in a perpendicular fashion from the second side(s) 12B,
16B of the components 12, 16 and/or in a lateral fashion from the
components 12, 16. Each of the pads 30 are comprised of a flexible
material and configured to provide an anchor through which sutures
or any other type of anchoring device may be inserted. For example,
and in at least one embodiment, one or more pads 30 may be
comprised of polyurethane or any other material that is capable of
securely holding sutures or another type of anchoring device
therein. One or more sutures may be placed within suture apertures
32 as shown in FIG. 3A, whereby said suture apertures 32 may be
positioned along pads 30 and/or one or both of components 12, 16 as
shown in FIG. 3A. Accordingly, after the first and second engaging
components 12, 16 are properly positioned about a targeted tissue
or organ, sutures may be inserted through suture apertures 32 and
secured to a superficial layer of the underlying targeted tissue or
organ to assist in anchoring the restraining device 10 in the
proper location thereon.
[0110] FIGS. 3B-3E show various embodiments of first engaging
component 12 and/or second engaging component 16 with various
features to facilitate suturing and/or connection of first engaging
component 12 to second engaging component 16. FIG. 3B shows an
exemplary embodiment if a first and/or second engaging component
12, 16 comprising suture apertures 32 positioned therethrough.
Suture apertures 32 are not limited to positioning near one or more
of the ends of said first and/or second engaging component 12, 16,
as such suture apertures 32 may be positioned along first and/or
second engaging component 12, 16 as desired.
[0111] FIG. 3C shows an exemplary embodiment of a first and/or
second engaging component 12, 16 comprising one or more strings 34
affixed thereto. In the exemplary embodiment shown in FIG. 3C, two
strings 34 are shown at or near the ends of first and/or second
engaging component 12, 16, noting, however, that one, two, or more
strings 34 may be affixed thereto and positioned as desired. In an
exemplary embodiment of a restraining device 10, and as shown in
FIG. 4B, the first engaging component 12 and the second engaging
component 16 may each comprise at least one string 34, whereby said
strings 34 may be connected to one another to facilitate a desired
placement of restraining device 10 about a stomach 100.
[0112] Additional embodiments of exemplary first and/or second
engaging components 12, 16 are shown in FIGS. 3D and 3E. As shown
in FIG. 3D, first and/or second engaging component 12, 16 comprises
one or more suture members 36 affixed thereto, with said suture
members defining an aperture to which a suture (not shown) or other
restraining component may be affixed thereto. FIG. 3E shows an
exemplary first and/or second engaging component 12, 16 of the
present disclosure comprising pads 30 positioned at or near each
end of the first and/or second engaging component 12, 16 with each
pad 30 defining a suture aperture 32 therethrough. Additional
embodiments of first and/or second engaging component 12, 16
comprising features to allow for a suture or other restraining
component to be positioned therethrough are also contemplated by
the present disclosure. For purposes of the present disclosure, the
term "suturing elements" shall mean any number of elements for
introducing a suture into the first and/or second engaging
component 12, 16 and/or one or more pads 30 affixed thereto,
including, but not limited to, one or more apertures 32, strings,
34, and/or suture members 36. In addition, any number of the
features of the various exemplary first and/or second engaging
components 12, 16 shown in FIGS. 3A-3E may appear in any number of
embodiments of restraining devices 10 of the present
disclosure.
[0113] In operation, the restraining device 10 may be applied to an
organ or tissue of interest in order to restore the underlying
tissue or organ into a desired configuration and/or provide support
to the same. As discussed in further detail below, the restraining
device 10 may be used for temporary or chronic implantation within
a body without the risk of the first and second engaging components
12, 16 migrating through or damaging the underlying tissue.
Furthermore, because the restraining device 10 does not require
that the underlying tissue be punctured in any significant manner
to achieve restoration and/or provide support thereto, implantation
of the restraining device 10 is entirely reversible and, if
desired, the restraining device 10 may be easily removed from the
organ or tissue of interest through a laparoscopic procedure.
[0114] As previously described, the specifications of the
restraining device 10 may be modified to achieve a desired result.
For example, and without limitation, the dimensions of the
components 12, 16 and/or the springs 22 may be chosen for a
particular application and/or based on the patient. Accordingly,
while certain embodiments of the restraining device 10 may be
described in connection with particular tissues or organs, it will
be appreciated that any of the embodiments of the restraining
device 10 described herein may also be applied to any tissue or
organ of interest in a similar manner and use of the particular
embodiments of the restraining device 10 in lieu of others may be
determined based on the patient's specifications, the specific
application, and/or the tissue or organ in question.
[0115] In practice, an exemplary restraining device 10 is capable
of restoring and/or supporting an underlying tissue while avoiding
constriction and the excessive compression thereof. For example,
the restraining device 10 may be applied to a stomach 100 as shown
in FIGS. 4A and 4B. In at least one embodiment, and as shown in
FIG. 4A, the springs 22 of the restraining device 10 are rotated to
the substantially perpendicular position such that the interior
space 70 is increased between the first and second engaging
components 12, 16. Thereafter, the restraining device 10 may be
advanced over the stomach 100 such that, for example, the first
side 12A of the first engaging component 12 is positioned adjacent
to the anterior wall of the stomach 100 and the first side 16A of
the second bar 16 is positioned adjacent to the posterior wall of
the stomach 100. While the restraining device 10 is shown in FIG.
4A in a longitudinal placement with respect to the stomach 100, it
will be understood that the restraining device 10 may alternatively
be positioned in a horizontal configuration or an angular
configuration with respect to the stomach 100.
[0116] After the first and second engaging components 12, 16 are
positioned in the desired location with respect to the stomach 100,
the overall interior space 70 may either comprise its original
native interior space 70 or a relatively larger interior space 70
due to the positioning of the restraining device 10 about the
stomach 100. Therefore, various embodiments of restraining device
10 do not operate to "clamp" the stomach 100 or any other tissue or
organ, as restraining device 10 merely operates, when positioned
around a stomach 100, to provide a limited pressure, if any, to
maintain a native size/shape of at least a portion of the stomach
100. For example, and depending upon the prescribed value of the
interior space 70 as desired by a clinician, the configuration of
the springs 22 can be modified to achieve a restraining device 10
that either does not compress, or only loosely compresses, the
sandwiched tissue between the first and second engaging components
12, 16. In a preferred embodiment, restraining device 10, when
positioned about a stomach 100, does not provide any meaningful
compressive pressure upon the stomach 100, and may be held in
place, for example, using one or more sutures as referenced herein.
In this manner, the restraining device 10 can be employed to
reversibly restore an organ or tissue without forming adhesions
thereon and/or permanently restoring the same.
[0117] In at least one embodiment, and depending on the
configuration of the springs 22, the springs 22 may exhibit enough
elasticity to enable the first and second engaging components 12,
16 to move to some degree in conjunction with any movement of a
tissue or organ positioned between the first and second engaging
components 12, 16 of the restraining device 10. In this manner, the
springs 22 can allow, for example, the restraining device 10 to
accommodate any inherent movement in the stomach 100 such that
application of the restraining device 10 does not completely
inhibit the normal digestive function of the same. For example, the
introduction of food into the stomach 100 may cause the outer
dimensions of the stomach 100 to expand, whereby stomach 100 exerts
a pressure upon restraining device 100. Furthermore, the
restraining device's 10 ability to accommodate any inherent
movement in the underlying organ and/or tissue increases the
likelihood that the restraining device 10 will remain in its
desired location on the tissue and/or organ without sheering off or
sliding therefrom.
[0118] In the event it is desired that the restraining device 10 is
further secured to the underlying tissue, and as previously
referenced herein, a clinician can employ sutures to assist with
the secure implantation of the restraining device 10 in the desired
location. In the at least one embodiment of the restraining device
10 comprising the one or more pads 30, a clinician can secure the
one or more pads 30 of the first and second engaging components 12,
16 to the underlying tissue through the use of superficial sutures.
In this manner, the superficial sutures can be affixed through the
one or more pads 30 and the surface of the underlying tissue such
that the one or more pads 30 assist with anchoring the restraining
device 10 in position on the tissue of interest. Conversely, and in
at least one embodiment, sutures may be introduced directly to the
first and/or second engaging components 12, 16 to secure a
restraining device to a tissue or organ of interest as shown in
FIGS. 3A-3E.
[0119] FIG. 4B shows a cross-sectional view of the stomach 100 of
FIG. 4A taken along A-A. As shown in FIG. 4B, when the first and
second engaging components 12, 16 of the restraining device 10 are
longitudinally positioned on the stomach 100, the stomach 100 is
"divided" into two portions--a first stomach portion 110 and a
second stomach portion 112 as shown in FIGS. 4A and 4B. In the
embodiment shown in FIGS. 4A and 4B, the first stomach portion 110
is relatively smaller than the second stomach portion 112. However,
and as shown in FIG. 5A, the first stomach portion 110 and the
second stomach portion 112 may be approximately the same size.
[0120] As the first stomach portion 110 receives ingested matter
directly from the gastroesophageal junction 99 as shown in FIG. 4A,
the placement of the restraining device 10 as shown in FIG. 4B thus
inhibits the majority of ingested matter from moving into the
second stomach portion 112. Instead, and in at least one
embodiment, such ingested matter is directed through the smaller,
first stomach portion 110 and into the pyloric canal 101 (as shown
in FIG. 4A) where a significant portion of the ingested matter is
evacuated from the stomach 100. Due to the size of the first
stomach portion 110, the amount of food that the patient can
consume at one time is significantly reduced and satiety is more
quickly achieved.
[0121] While the delineation formed by the restraining device 10
between the first stomach portion 110 and the second stomach
portion 112 is not leak-proof, the interior space 70 created
between the first and second engaging components 12, 16 comprises
an area that is less than the diameter of a fully extended stomach
100 (as shown in FIG. 4B). Accordingly, when the restraining device
10 is applied in a longitudinal fashion to a stomach 100,
restraining device 10 provides support to the anterior and
posterior walls of the stomach 100, with the expansion of stomach
100 exerting a force onto the first and second engaging components
12, 16 of restraining device 10, this preventing stomach 100
distension in that area. In this manner, most of the food matter
received into the first stomach portion 110 through the
gastroesophageal junction 99 is maintained therein and the patient
exhibits the sensation of satiety earlier.
[0122] Referring back to FIG. 4A, and in at least one exemplary
embodiment, because the restraining device 10 does not extend along
the entire length of the stomach 100, an outflow tract 114 is
formed caudally of the restraining device 10. This outflow tract
114 allows the portion of ingested matter that flows from the
gastroesophageal junction 99 into the second stomach portion 112 to
be evacuated from the stomach 100 in a controlled manner and to
proceed through normal digestion. In addition, the outflow tract
114 allows any food matter or enzymes residing within the second
stomach portion 112 to evacuate the stomach 100.
[0123] Additional embodiments of restraining devices 10 of the
disclosure of the present application positioned about a stomach
100 are shown in FIGS. 5B and 5C. In the exemplary embodiment shown
in FIG. 5B, restraining device 10 comprises first and second
engaging components 12, 16 which are "longer" than those shown in
FIG. 5A, whereby distal end 14 of first engaging component 12 and
distal end 18 of second engaging component 16 extend past stomach
100. In this exemplary embodiment, strings 34 affixed to first and
second engaging components 12, 16 may be connected/tied to each
other after restraining device 10 has been positioned about a
stomach, maintaining restraining device 10 in place.
[0124] FIG. 5C shows restraining device 10 positioned about stomach
100 viewed in the direction of the arrow shown in FIG. 5B. As shown
in FIG. 5B, the tying/coupling together of strings 34 at the distal
ends 14, 18 of first and second engaging components 12, 16 may
cause portions of the first and second engaging components 12, 16
to angle towards one another as shown in FIG. 5C. In this
particular embodiment, first and second engaging components 12, 16
are flexible or semi-flexible, and the positioning of restraining
device 10 about stomach 100 serves to isolate the first stomach
portion 110 from fundus 90 and greater curvature 92. This "funnel"
effect, in addition to the embodiment of a restraining device 10
shown in FIG. 5D below, may also be accomplished by having springs
22 with relatively shorter rods 24 (or relatively smaller struts
700 as referenced in various embodiments herein) at one end of
restraining device 10, and by having springs 22 with relatively
longer rods 24 (or relatively larger struts 700 as referenced in
various embodiments herein) at the other end of restraining device
10. In addition as to being substantially rigid as shown in FIGS. 1
and 2, and as shown in FIG. 5C, first and second engaging
components 12, 16 may have substantially rigid center portions and
one or more flexible or semi-flexible ends, or first and second
engaging components 12, 16 may be flexible or semi-flexible along
the entirety of said components 12, 16.
[0125] An additional embodiment of a restraining device 10 of the
present disclosure positioned about stomach 100 is shown in FIG.
5D. As shown in FIG. 5D, and as also discussed herein regarding
FIG. 10, restraining device 10 further comprises a pliable junction
1000 positioned within the first engaging component 12 and second
engaging component 16, effectively "splitting" each component,
whereby each "split" component is connected to one another by way
of a flexible structure 1002. As shown in FIG. 5D, flexible
structure 1002 may comprise a PTFE band or a PTFE mesh, for
example, whereby any potential embodiment of flexible structure
1002, using one or more pliable materials disclosed herein or
otherwise known in the art, allows the relatively or fully rigid
first engaging component 12 and second engaging component 16 to
better fit the stomach, allowing the patient, for example, to bend
the stomach when restraining device 10 is positioned thereon.
[0126] Approximating first and second engaging components 12, 16,
as shown in FIGS. 5B, 5C, and 5D, and as identified during internal
testing of exemplary restraining devices 10 of the present
disclosure, leads to reduced food intake (65-70% of normal food
intake) as compared to positioning restraining device 10 about
stomach 100 without approximating first and second engaging
components 12, 16 toward one another as shown in FIG. 4A (80-85% of
normal food intake). This approximation also assists with the
prevention of a fistula so that the food may move down the pouch
(first stomach portion 110) along antrum 94 as opposed to shunted
to the fundus 90 of stomach 100.
[0127] As described herein, application of the restraining device
10 allows a clinician to restore a targeted tissue, such as a
stomach 100, while avoiding constriction and excessive compression
of the same. Further, the various embodiments described herein
allow a clinician to tailor the restraining device 10 to multiple
restoration applications and various different types of tissues.
Permanent restoration of the tissue is avoided, which prevents
adhesions from developing in the underlying targeted tissue and
allow for the complete reversal of the restoration procedure.
Additionally, the restraining device 10 is simple to deliver and,
as such, the device 10 may be used in conjunction with other
techniques or surgical procedures.
[0128] Regarding the application of the restraining device 10 to
the stomach 100, use of the restraining device 10 in the treatment
of obesity avoids the nutritional and metabolic deficiencies
observed after Malabsorptive Procedures because the digestive
process may continue within the stomach as with a native stomach
100. In addition, the restraining device 10 does not require more
than superficial punctures to the underlying tissue, nor does it
employ pins, staples or significant sutures which may lead to
dehiscence or fistula formation, or produce the degree of
regurgitation and vomiting observed in connection with conventional
methods used to treat obesity. Moreover, each of the embodiments
described herein may be inserted into the body cavity
laparoscopically, thereby decreasing the patient's stress
associated with the procedure and the patient's recovery time. It
will be recognized that any of the devices described herein may be
employed in combination with other conventional bariatric
procedures.
[0129] Now referring to FIG. 6, a flow chart of a method 300 for
laparoscopically delivering the restraining device 10 is shown. For
ease of understanding, the steps of the related methods described
herein will be discussed relative to the components of an exemplary
restraining device 10. Furthermore, while the methods described
herein are described in connection with embodiments of the
restraining device 10 and an exemplary delivery device, it will be
appreciated that various additional devices may be used to
facilitate the laparoscopic delivery of the restraining device 10
such as a camera, light and/or a device for delivering a gas to a
targeted area.
[0130] At step 302, the first and second engaging components 12, 16
of restraining device 10 are advanced laparoscopically into the
patient's body. In at least one embodiment, the restraining device
10 may be inserted through a 15 millimeter cannula under
insufflation into the appropriate cavity of the patient's body.
This may be achieved through use of an exemplary delivery device
known in the art. At this step 302, the springs 22 of the
restraining device 10 are positioned in the substantially parallel
position such that the overall diameter of the restraining device
10 is sufficiently narrow for insertion into the body.
[0131] At step 304 the restraining device 10 is advanced to a
location adjacent to a targeted tissue. In the at least one
embodiment of the method 300 where an exemplary delivery device is
employed to facilitate delivery of the restraining device 10 to the
targeted tissue, at step 304 the restraining device 10 is advanced
out of the delivery device and into the body cavity. After the
restraining device 10 is no longer positioned within an exemplary
delivery device, the delivery device may be withdrawn from the body
cavity at this step 304 or as desired by the clinician.
[0132] At step 306, the springs 22 of the restraining device 10 are
rotated from the substantially parallel position to the
substantially perpendicular position, separating the first and
second engaging components 12, 16 from one another to a native
interior space 70. Step 306 may be performed using any number of
standard laparoscopic tools known in the art useful to pull and
grasp portions of a tissue or a device. In this manner, neither the
proximal ends 13, 17 nor distal ends 14, 18 of the first and second
engaging components 12, 16 of the restraining device 10 are blocked
by the springs 22 and/or rods 24, and the first and second engaging
components 12, 16 may be advanced over a targeted tissue having a
length that is greater than the overall length of the first and
second engaging components 12, 16.
[0133] At step 308, under fluoroscopic, direct camera control or
otherwise, the restraining device 10 is advanced over the targeted
tissue. In at least one embodiment, and at step 308, the first side
12A of the first engaging component 12 is positioned adjacent to
the desired surface of the targeted tissue and the first side 16A
of the second engaging component 16 is positioned adjacent to an
opposite side of the targeted tissue. As the first and second
engaging components 12, 16 of the restraining device 10 are
positioned adjacent to opposite sides of the targeted tissue, at
this step 308 the targeted tissue is positioned within the interior
space 70 formed between the first and second engaging components
12, 16. Accordingly, while the targeted tissue may experience some
compressional force exerted by the first and second engaging
components 12, 16 of the restraining device 10, the majority of the
pressure upon the first and second engaging components 12, 16 is
provided by distension/expansion of the targeted tissue (for
example, expansion of a stomach 100 when food is introduced
therein). Further, due to the configuration and composition of the
restraining device 10, the restraining device 10 can remain within
the patient's body for as long as the restoration or support
treatment delivered thereby is desired.
[0134] If preferred, in at least one embodiment of the restraining
device 10 that further comprises one or more pads 30 coupled with
the first and/or second engaging components 12, 16, the method 300
may advance from step 308 to step 310. At step 310, a clinician can
employ sutures to further anchor and secure the restraining device
10 in the desired position on the targeted tissue. These sutures
need only superficially puncture the underlying tissue and
therefore are not associated with the negative effects associated
with suturing, stapling and/or the insertion of pins used in
conventional methods.
[0135] Additional embodiments of restraining devices 10 of the
disclosure of the present application is shown in FIGS. 7A and 7B.
As shown in FIGS. 7A and 7B, restraining device 10 comprises a
first engaging component 12 and a second engaging component 16,
whereby the first engaging component 12 and second engaging
component 16 are coupled to one another by way of one or more
struts 700. In the exemplary embodiment shown in FIGS. 7A and 7B,
four struts 700 and five struts 700 are used, respectively, but any
number of struts 700 may be used as desired for a particular
application. Struts 700 may comprise any number of suitable
materials as otherwise described herein, including, but not limited
to, nitinol and stainless steel. Struts 700, in an exemplary
application, would have a pre-established "open" size and a
pre-established "strength", so that restraining device, in a native
"rest" configuration, would be "open" (by way of, for example, the
"memory" of struts 700) and would require some sort of
pressure/force to open even further. The "open" configuration would
keep first engaging component 12 and second engaging component 16 a
fixed distance apart to avoid gastric tissue compression when
positioned about a stomach.
[0136] An exemplary restraining device 10 may further comprise a
mesh curtain 702 coupled to struts 700 as shown in FIGS. 7A and 7B.
Mesh curtain 702 may prevent or limit potential organ distension or
remodeling when restraining device 10 is positioned about an organ
of interest. A demi shaft 704, as shown in FIGS. 7A and 7B, may be
positioned around at least part of struts 700 and/or mesh curtain
702 to facilitate insertion of restraining device 10 within a body.
For example, and as shown in FIG. 7A, restraining device 10 may be
seen as inserted within a body, noting that restraining device is
somewhat compressed by demi shaft 704, to facilitate insertion
through, for example, a laparoscopic port. After insertion, and as
shown in FIG. 7B, demi shaft 704 may be withdrawn in the direction
of the arrow (shown as partially withdrawn in the figure) to allow
restraining device 10 to obtain its original, uncompressed
configuration, and ultimately removed from the body. Struts 702 may
have a first configuration when positioned within demi shaft 704,
as shown in FIG. 7A, and may have a second configuration when demi
shaft 704 is removed, as shown on the left side of FIG. 7B.
[0137] When restraining device 10 is in its native configuration,
it may then be positioned about a stomach, for example, and the
user positioning restraining device 10 may grasp stomach tissue
using any number of laparoscopic tools through mesh aperture 706 as
shown in FIGS. 7B and 8. As shown in FIG. 8, an exemplary
restraining device 10 may also comprise one or more suture members
36 to allow one or more sutures (not shown) to be used to secure
restraining device 10 to, for example, an anterior gastric
wall.
[0138] An additional embodiment of a restraining device 10 of the
disclosure of the present application is shown in FIG. 9. As shown
in FIG. 9, restraining device 10 comprises a first engaging
component 12 and a second engaging component 16, whereby first
engaging component 12 and second engaging component 16 are coupled
to one another by way of one or more springs 22. In this exemplary
embodiment, restraining device 10 further comprises a mesh curtain
702 coupled to first engaging component 12 and second engaging
component 16, whereby mesh curtain 702 may prevent or reduce organ
distension or remodeling when restraining device 10 is positioned
about an organ. The flexibility/pliability of mesh curtain 702
would allow mesh curtain 702 to be closely positioned first
engaging component 12 and second engaging component 16 upon
insertion of restraining device 10 within a body, and may further
allow mesh curtain 702 to expand in a direction of springs 22 as
shown in FIG. 9, for example, to prevent organ distention.
[0139] FIG. 10 shows yet another embodiment of a restraining device
10 of the present application. As shown in FIG. 10, restraining
device comprises a first engaging component 12 and a second
engaging component 16, whereby first engaging component 12 and
second engaging component 16 are coupled to one another by way of
one or more springs 22. However, in this exemplary embodiment,
restraining device 10 further comprises a pliable junction 1000
positioned within the first engaging component 12 and second
engaging component 16, effectively "splitting" each component,
whereby each "split" component is connected to one another by way
of a flexible structure 1002. As shown in FIG. 10, flexible
structure 1002 may comprise a PTFE band or a PTFE mesh, for
example, whereby any potential embodiment of flexible structure
1002, using one or more pliable materials disclosed herein or
otherwise known in the art, allows the relatively or fully rigid
first engaging component 12 and second engaging component 16 to
better fit the stomach, allowing the patient, for example, to bend
the stomach when restraining device 10 is positioned thereon. In
addition, and as shown in the exemplary embodiment in FIG. 10,
restraining device 10 may further comprise a tissue cover 1004
positioned either partially or fully around either or both of first
engaging component 12 and second engaging component 16.
[0140] FIG. 11 shows an exemplary embodiment of a restraining
device 10 of the present application positioned within a
laparoscopic port. As shown in FIG. 11, restraining device 10 is
shown as being inserted into a body portion by way of laparoscopic
port 1100, with the exemplary laparoscopic port 1100 shown as
comprising a ring 1102 and a port sleeve 1104 to facilitate
introduction of restraining device 10 through an abdominal wall
1106. Viewing the figure from the outside-in, restraining device 10
is shown as being introduced into an abdomen through abdominal wall
1106, with peritoneum 1108 shown as being an innermost layer of the
abdominal wall.
[0141] An additional embodiment of a restraining device 10 of the
disclosure of the present application is shown in FIG. 12A. As
shown in FIG. 12A, restraining device 10 comprises a first engaging
component 12 and a second engaging component 16, whereby first
engaging component 12 and second engaging component 16 are coupled
to one another by way of one or more couplers 1200. In this
exemplary embodiment, restraining device comprises two couplers
1200, shown in further detail in FIG. 12B. Couplers 1200 may
comprise coupler arms 1202 connected to one another by way of a
coupler bar 1204, and may comprise any number of suitable materials
as described herein for various components of the present
disclosure. As shown in FIG. 12A, coupler arms 1202 may be
positioned within first engaging component 12 and second engaging
component 16 by way of apertures 1210 (as shown in FIG. 12B)
defined therein, allowing first engaging component 12 and second
engaging component 16 to move relative to one another as couplers
1200 swivel when positioned at least partially within said
apertures 1210.
[0142] As shown in FIG. 12B, an exemplary embodiment of a coupler
1200 may comprise a coupler protrusion 1206 at or near the end of
each coupler arm 1202, whereby coupler protrusions either prevent
or restrict the removal of coupler 1200 from the either first
engaging component 12 or the second engaging component 16 by way of
stops 1208 positioned about the first engaging component 12 and the
second engaging component 16 at or near the apertures 1210 defined
therein. As coupler 1200 moves in the direction of the arrow shown
in FIG. 12B, coupler protrusions 1206 would engage stops 1208, thus
preventing or restricting the removal of coupler 1200 from the
first engaging component 12 and/or the second engaging component
16.
[0143] Insertion of the exemplary embodiment of the restraining
device 10 shown in FIG. 12A into a body portion may be performed by
inserting said restraining device 10 through a laparoscopic port
with first engaging component 12 and second engaging component 16
either touching or nearly touching one another, and with couplers
1200 either mostly or fully inserted within apertures 1210 of
restraining device 10. When restraining device has been inserted
into a body portion, first engaging component 12 and second
engaging component 16 may be separated a pre-established distance
from one another my way of turning/swiveling couplers 1200. As
such, couplers 1200, as well as first engaging component 12 and
second engaging component 16, may be sized and shaped as desired
for a particular application,
[0144] FIGS. 13A and 13B show an exemplary embodiment of a
restraining device 10 with a coupler 1200 positioned therein in a
configuration to maximize the interior space 70 between first
engaging component 12 and second engaging component 16. As such,
the configuration of coupler 1200 shown in FIG. 12A may be viewed
as "closed," while the configuration shown in FIG. 13A may be
viewed as "open." In addition, and as described above and shown in
FIG. 13A, coupler 1200 may be withdrawn from apertures of first
engaging component 12 and second engaging component 16 to
facilitate placement of restraining device about an organ of
interest, Such withdrawal may be performed using any number of
laparoscopic tools, for example, whereby coupler 1200 is withdrawn
up to a point where protrusions 1206 would engage stops 1208 as
shown in FIG. 12B.
[0145] Another exemplary embodiment of a restraining device 10 of
the disclosure of the present application is shown in FIGS. 14A and
14B. As shown in FIGS. 14A and 14B, restraining device 10 comprises
a first engaging component 12 and a second engaging component 16,
whereby first engaging component 12 and second engaging component
16 are coupled to one another by way of one or more couplers 1200.
In the embodiments shown in FIGS. 14A and 14B, couplers 1200
comprise "scissor" couplers 1200, whereby at least two coupler bars
1204 are connected to one another via a pivot member 1400 so that
coupler bars 1204 may pivot about one another at pivot member 1400.
As coupler 1200 shifts from a "closed" configuration, as shown in
FIG. 14A, to an "open" configuration, as shown in FIG. 14B, coupler
bars 1204 pivot about pivot member 1400 causing coupler bars 1204
to move closer to one another in a direction opposite the direction
of the length of first engaging component 12 and second engaging
component 16.
[0146] Couplers 1200, as shown in FIGS. 14A and 14B, may "open" and
"close" by way of movement of coupler arms 1202 (ends shown in the
two figures) within apertures 1210 defined within first engaging
component 12 and second engaging component 16. Apertures 1210, as
shown in these exemplary embodiments, are configured as horizontal
grooves to allow coupler arms 1202 to move closer to one another
within the same aperture 1210 while coupler 1200 is "opening" and
to allow coupler arms 1202 to move away from one another within the
same aperture 1210 while coupler 1200 is "closing." As shown in
FIG. 14B, restraining device 10, in a fully open position, would
maximize the interior space 70 between first engaging component 12
and second engaging component 16. Protrusions 1402, such as teeth,
indentations, and the like, may be positioned at or near apertures
1210, as shown in FIG. 14B, to facilitate fixation of coupler arms
1202 in a desired position, allowing a user positioning restraining
device 10 within a body to measure the exact the interior space 70
between first engaging component 12 and second engaging component
16.
[0147] Upon insertion of the exemplary embodiment of restraining
device 10 shown in FIGS. 14A and 14B within an abdominal cavity
(through a laparoscopic port, for example), any number of
laparoscopic tools may be used to grasp couplers 1200 to withdraw
them from first engaging component 12 and second engaging component
16 as referenced herein regarding various other embodiments of
restraining devices 10.
[0148] An exemplary delivery apparatus for delivering a restraining
device 10 of the present application is shown in FIGS. 15A and 15B.
As shown in FIG. 15A, an exemplary delivery apparatus 1500
comprises a shaft 1502 and arms 1504 at or near a distal end 1506
of shaft 1502. Apparatus 1500 may further comprise string 1508,
whereby string 1508 may either be coupled to or engaged by a pull
bar 1510 (an exemplary "puller" of the present disclosure)
positioned within the lumen of apparatus 1500. Arms 1504 may engage
an outer surface of first engaging component 12 and second engaging
component 16, a protrusion (not shown) extending from said
components, or by way of a groove 1512 (shown in FIG. 15B)
positioned within said components.
[0149] As shown in FIG. 15A, string 1508 is coupled to springs 22
of restraining device 10, whereby a "pulling" motion of pull bar
may effectively pull springs 22 from a first configuration (not
shown in FIG. 15A) to a second configuration as shown in FIG. 15A
so that restraining device may be positioned about an organ of
interest. In an additional embodiment, string 1508 may be
positioned at least partially within the lumen of apparatus 1500,
whereby a user of apparatus may pull string 1508 instead of pulling
pull bar 1510 to operate apparatus 1500. Various components of
apparatus 1500 may comprise any number of suitable materials,
including, but not limited to, the various materials referenced
herein in connection with components of restraining device 10. For
example, string 1508 may comprise, for example, plastic or metal
thread.
[0150] For example, and in an abdominal cavity with the epiplon
lesser curvature dissected, arms 1504 of apparatus 1500 may
position restraining device 10 to a desired location, springs 22 of
restraining device 10 may be widely opened, thus separating the
first engaging component 12 and the second engaging component 16 by
using pull bar 1510 to pull the strings 1508 and move springs 22
from an axial position to a 90. degree. position relative to first
engaging component 12 and the second engaging component. An
"opened" restraining device 10 may then be introduced through the
dissected lesser curvature space in parallel position to the
intragastric mannequin tube, thus creating a desired pouch size.
First engaging component 12 and second engaging component 16, upon
positioning restraining device 10 about a stomach, would occupy the
anterior and posterior wall of the stomach. When the first engaging
component 12 and the second engaging component 16 are located in
the desired position, spring 22 approximates the first engaging
component 12 and the second engaging component 16 to each other
gradually without producing any ischemic or tissue damage. Upon
moving springs 22 to their desired location and/or positioning
restraining device 10 about the stomach, restraining device 10 is
separated from apparatus 1500, strings 1508 are cut and apparatus
1500 is pulled out of the abdominal cavity through the port.
Restraining device 10 may then be secured in the gastric tissue
with superficial stitches.
[0151] FIG. 15B shows an exemplary embodiment of at least a portion
of apparatus 1500 engaging a "closed" restraining device 10. As
shown in FIG. 15B, arms 1504 of apparatus 1500 are shown engaging
first engaging component 12 and second engaging component 16 of
restraining device 10 by way of grooves 1512 positioned within said
components, permitting apparatus 1500 to deliver restraining device
10 through an abdominal port.
[0152] FIGS. 16A and 16B show an exemplary embodiment of an
apparatus 1500 engaging/positioning an exemplary restraining device
10 of the disclosure of the present application. As shown in FIGS.
16A and 16B, arms 1504 of apparatus 1500 may engage the first
engaging component 12 and the second engaging component 16 of
restraining device 10, whereby the "opening" of arms 1504 would
facilitate the "opening" of restraining device from a "closed"
configuration (as shown in FIG. 16A) to an "open" configuration (as
shown in FIG. 16B).
[0153] "Opening" restraining device 10, as shown in FIG. 16B, may
be performed as follows. In the abdominal cavity with the epiplon
lesser curvature dissected, the arms 1504 of apparatus 1500 may be
widely opened, thus separating the first engaging component 12 and
the second engaging component 16 of restraining device 10. A
surgeon, for example and with the aid of laparoscopic graspers, may
then "pull" out couplers 1200, placing couplers 1200 in a withdrawn
configuration as shown in FIG. 16B. Restraining device 10, in an
"open" configuration, may be introduced through the dissected
lesser curvature space in parallel position to the intragastric
mannequin tube, thus creating the desired stomach pouch size. First
engaging component 12 and second engaging component 16, when
positioned about a stomach, would occupy the anterior and posterior
wall of the stomach. When the first engaging component 12 and the
second engaging component 16 are located in the desired position,
the user/operator may then approximate the plates to each other
gradually (millimetrically) using apparatus 1500 device without
producing any ischemic or tissue damage. When the user/operator has
positioned restraining device 10, apparatus 1500 would then be
separated from restraining device and pulled out of the abdominal
cavity through the port. If desired, restraining device may also be
secured in the gastric tissue with superficial stitches.
[0154] FIGS. 17A and 17B show another exemplary embodiment of an
apparatus 1500 engaging/positioning an exemplary restraining device
10 of the disclosure of the present application. As shown in FIGS.
17A and 17B, arms 1504 of apparatus 1500 may engage the first
engaging component 12 and the second engaging component 16 of
restraining device 10, whereby the use of string 1508 connected to
the first engaging component 12 and the second engaging component
16 may be used by an operator of apparatus 1500 to "open" and/or
"close" said components. One or more strings 1508, in such
exemplary embodiments, may be coupled at their first ends to the
first engaging component 12 and/or the second engaging component
16, and may be coupled at their second ends to a string rotator
1700 (another exemplary "puller" of the present disclosure) as
shown in FIGS. 17A and 17B. Operation/rotation of string rotator
1700 may then facilitate the "opening" of restraining device 10
from a "closed" configuration (as shown in FIG. 17A) to an "open"
configuration (as shown in FIG. 17B). In such an embodiment, arms
1504 may also be positioned upon the first engaging component 12
and/or the second engaging component 16 at or near the center of
said components (forming a "pivot" area), and the string rotator
1700 and strings 1504 affixed thereto may operate to keep said
components in their axial position. Ultimate restraining device 10
delivery may be performed using one or more methods described
herein.
[0155] Restraining device 10 may also be positioned
"perpendicularly" using apparatus 1500 as shown in FIG. 18. As
shown in FIG. 18, arms 1504 and strings 1508 are shown positioned
about the first engaging component 12 and the second engaging
component 16 "perpendicularly" so that restraining device 10 and
apparatus 1500 are not aligned with one another. Rotation of string
rotator 1700, as described above, may facilitate the opening and/or
closing of restraining device 10.
[0156] The various embodiments of restraining devices 10 of the
present disclosure may be introduced into a body cavity through,
for example, a laparoscopic port. Such restraining devices 10 would
be inserted while "compressed" (as shown in FIGS. 1, 7A, 10, 11,
12A, and 14A, for example), and when inserted, would be "opened" or
"deployed" (as shown in FIGS. 2, 7B, 8, 9, 13A, 13B, and 14B, for
example) prior to being positioned about a stomach 100. In
addition, a user of such a restraining device 10 may adjust the
opening/deployed dimensions of restraining device 10 prior to
positioning it about a stomach, and may further tailor the
open/deployed dimensions of restraining device 10 after it has been
positioned as desired.
[0157] Furthermore, any number of exemplary embodiments of
restraining devices 10 of the present application may be wholly or
partially resorbable by the body. For example, and using the
exemplary restraining device 10 shown in FIGS. 1 and 2 as an
example, first and second engaging components 12, 16 may not be
resorbable by the body, while springs 22 may be resorbable. In such
an embodiment, restraining device 10, once positioned about a
stomach 100, may slowly begin the process of total or partial
resorption. Resorbable materials suitable for one or more portions
of restraining devices 10 may include, but are not limited to,
polyglycolide (PGA), polylactide (PLA), l-lactide (LPLA),
poly(dl-lactide) (DLPLA), poly(.epsilon.-caprolactone) (PCL),
poly(dioxanone) (PDO), polylglycolide-trimethylene carbonate
(PGA-TMC), poly(d,l-lactide-co-glycolide) (DLPLG), or combinations
thereof.
[0158] In a situation where it is desired to have restraining
device 10 serve as a reversible bariatric device, and if it is
desired not to engage in a subsequent procedure to, for example,
laparoscopically remove some or all of restraining device 10 from a
body, some or all of restraining device 10 may be resorbed. By way
of example, an exemplary restraining device comprising resorbable
springs 22 may be positioned about a stomach, and first and second
engaging components 12, 16 may slowly become coated with various
fibrotic tissue. As springs 22 resorb, springs 22 will eventually
no longer operate to connect first and second engaging components
12, 16 to one another, which will effectively cause the various
portions of restraining device 10 to no longer serve as a
restraining mechanism. Springs 22 may also become coated, in part
or in their entirety, by fibrotic tissue, so that when springs 22
resorb, first and second engaging components 12, 16 remain
positioned about stomach 100, but the introduction of food into a
stomach 100, for example, does not exert any pressure on springs 22
by way of first and second engaging components 12, 16 as first and
second engaging components 12, 16 are no longer connected to one
another by way of springs 22. Furthermore, first and second
engaging components 12, 16 may be resorbable and springs 22 may
not, so as first and second engaging components 12, 16 resorb
within the body, springs 22 no longer serve to connect first and
second engaging components 12, 16 to each other, and restraining
device 10 no longer performs any restraining function. Additional
embodiments of restraining devices 10 may be resorbable, including,
but not limited to, struts 700 and mesh curtain 702.
[0159] Regarding removal of exemplary embodiments of restraining
devices 10 of the present application, said restraining devices 10
may be removed in whole or in part, for example, by way of a
laparoscopic procedure. Reversibility of restraining devices 10, as
referenced in the present application, pertains to the ability to
position a restraining device 10 about a tissue or organ, and at
some time thereafter, have some or all of restraining device 10
resorb within a body or remove some or all of restraining device
from the body so that restraining device 10 no longer functions to
restrain a tissue or organ. For example, and referencing the
exemplary embodiments shown in FIGS. 1 and 2, a laparoscopic
procedure to remove springs 22 from the restraining device 10 and
the body, but not to remove first and second engaging components
12, 16 from the body, would have the effect of "reversing" the
procedure of placing said restraining device 10 about a tissue or
organ. Similarly, and as shown in FIGS. 7A, 7B, and 8, removal of
struts 700 from restraining device 10 would also have the effect of
"reversing" the placement of restraining device 10 about a tissue
or organ.
[0160] Furthermore, and if desired, the entirety of restraining
device 10 may be removed laparoscopically by, for example,
reversing the steps used to insert said restraining device 10
within a body. For example, a method 1900 for removing a
restraining device 10 from a body as shown in FIG. 19 may comprise
the steps of withdrawing restraining device 10 from a tissue or
organ (withdrawal step 1904), configuring restraining device 10 to
fit within a laparoscopic port (configuration step 1906), and
removing restraining device 10 from the body through a laparoscopic
port (removal step 1908). Such an exemplary method may be preceded
by positioning a laparoscopic port within a body to facilitate
removal of restraining device 10 (port insertion step 1902), and
may be followed by removing said laparoscopic port from the body
after removal step 1908 (port removal step 1910).
[0161] Additional embodiments of restraining devices 10 of the
present disclosure are shown in FIGS. 20 and 23. As shown in the
embodiments shown in FIGS. 20 and 23, restraining devices 10
comprise a first engaging component 12 and a second engaging
component 16, such as those provided in various other embodiments
herein. First engaging component 12 and second engaging component
16, in such an exemplary embodiment, are positioned relatively
parallel to one another. A first swivel arm 2000 and a second
swivel arm 2002 are pivotally connected to first engaging component
12 and second engaging component 16, so that first swivel arm 2000
engages first engaging component 12 at pivot point 2004 and engages
second engaging component 16 at pivot point 2006, and so that
second swivel arm 2002 engages first engaging component 12 at pivot
point 2008 and engages second engaging component 16 at pivot point
2010. First swivel arm 2000 and second swivel arm 2002 may swivel
in the directions shown in arrows A and B in FIGS. 20 and 23,
noting that first swivel arm 2000 and second swivel arm 2002 may
move in opposite directions, so that one moves in the direction of
arrow A and the other moves in the direction of arrow B, or first
swivel arm 2000 and second swivel arm 2002 may move in the same
direction.
[0162] First engaging component 12 and/or second engaging component
16 may present studs 2012, as shown in FIGS. 20 and 23, whereby
studs 2012 permit first swivel arm 2000 and/or second swivel arm
2002 to be engaged thereto and permit swiveling/rotation about the
various pivot points. In at least one embodiment, studs 2012 have a
bulbous component relatively larger than a non-bulbous portion, so
that a first swivel arm 2000 and/or a second swivel arm 2002
presenting one or more apertures 2014 therethrough may engage studs
2012. Any number of other means to couple first swivel arm 2000
and/or second swivel arm 2002 to first engaging component 12 and/or
second engaging component 16 may be used, such as pins, rivets,
snaps, screws, and/or other fasteners or coupling means.
[0163] First swivel arm 2000 and second swivel arm 2002, as shown
in FIGS. 20 and 23, may further comprise a first interconnection
arm 2016 and a second interconnection arm 2018 positioned relative
to bends 2020, 2022 of said arms. Bends 2020, 2022, as shown in
FIGS. 20 and 23, are positioned in the relative middle (somewhere
between the relative ends) of first swivel arm 2000 and a second
swivel arm 2002, so that first swivel arm 2000 and second swivel
arm 2002 form a relative "U-shape" within restraining device 10.
First swivel arm 2000 and/or a second swivel arm 2002 may further
comprise various additional curvatures 2024, such as shown in FIG.
20, such that bends 2020, 2022 and/or curvatures 2024 define a
native U-shaped configuration as previously described.
[0164] An interior space 70 between the first engaging component 12
and the second engaging components 16, as shown in FIGS. 20 and 23,
may change depending on various factors and/or configurations of
restraining device 10. For example, and during insertion of an
embodiment of a restraining device 10 such as shown in FIG. 20 or
23 through a laparoscopic port, first swivel arm 2000 and a second
swivel arm 2002 may be relatively parallel to, or in the same
relative plane as, first engaging component 12 and second engaging
component 16, so that the interior space 70 is relatively small.
After insertion, and after swiveling first swivel arm 2000 and a
second swivel arm 2002 about first engaging component 12 and second
engaging components 16, the interior space 70 may either stay the
same or increase to facilitate placement of restraining device 10
about a stomach, for example. Furthermore, the use of a tape 2026
positioned about one or more of the first swivel arm 2000 and the
second swivel arm 2002, as shown in FIG. 20, may further adjust the
amount of interior space 70 between the first engaging component 12
and the second engaging components 16 depending on the amount of
relative tension (pull) is applied to tape 2026. For example, if
tape 2026 is positioned about one or more of the first swivel arm
2000, and the second swivel arm 2002 so that pulling tape 2026 in a
direction shown by arrow C in FIG. 20 causes portions of tape 2026
to press against first interconnection arm 2016 and/or second
interconnection arm 2018 causing the relative ends of each of first
swivel arm 2000 and a second swivel arm 2002 to move toward each
other, the amount of interior space 70 between first engaging
component 12 and second engaging component 16 may be reduced. In
such an embodiment, restraining device 10 could be inserted into a
mammalian body, positioned around a bodily organ without applying
pressure to said organ, and tape 2026 could be pulled so that the
amount of interior space 70 is adjusted as desired for the
particular application. In a bariatric application, for example, it
is desired not to have portions of restrictive device 10 apply any
pressure about the stomach, but tape 2026 could be pulled/adjusted
so first engaging component 12 and second engaging component 16
properly engage the stomach and be sutured thereto as desired.
Distention of the stomach, such as by the introduction of solid
and/or liquid food or water into the stomach, would cause the
stomach to exert a force/pressure against the first engaging
component 12 and second engaging component 16, forming a first
stomach portion 110 and a second stomach portion 112 as shown in
FIGS. 4A and 4B referenced above and FIG. 21 referenced below.
[0165] In addition, and as shown in the exemplary embodiments of
restraining devices 10 of the present disclosure shown in FIGS. 20
and 23, various portions of restraining device 10, such as the
first engaging component 12, the second engaging component 16, the
first swivel arm 2000, and/or the second swivel arm 2002 may have
one or more suture apertures 32 defined therethrough to facilitate
the placement of one or more sutures 34 (also referred to herein as
strings 34) to couple restraining device 10 to a portion of a
mammalian body, such as a stomach. In various embodiments, one or
more of the relative ends of the first engaging component 12 and
the second engaging component 16 may be rounded and/or tapered to
improve overall patient comfort when a restraining device is
positioned within the patient's body.
[0166] FIG. 21 shows an exemplary embodiment of a restraining
device 10, such as shown in FIG. 20, positioned about a stomach. As
shown in FIG. 21, device 10 may be positioned about stomach 100
similar to placement of restraining device 10 about stomach 100 as
shown in FIG. 5B, so that the first engaging component 12 and the
second engaging component 16 (not shown in FIG. 21) may engage
opposite sides of stomach 100. Restraining device 10 may be secured
to stomach 100 using one or more sutures 34 to couple restraining
device 10 to stomach 100, and restraining device 100 may be further
positioned about stomach 100 by way of adjusting tape 2026
positioned around restraining device 10. As shown in FIG. 21, tape
2026 is positioned about restraining device 10 so to engage first
interconnection arm 2016 and second interconnection arm 2018,
whereby pulling tape 2026 in a direction shown by arrow C would
cause first engaging component 12 and second engaging component 16
to move closer to one another. Tape 2026 may have one or more
detectable portions 2100 positioned/imprinted thereon, so that a
user of restraining device 10 can "see" the adjustment of tape 2026
by way of fluoroscopy (if detectable portions 2100 are
radioopaque), camera, or other means whereby portions of a device
positioned within a body can be visualized, either directly or
through some sort of technological means, to allow a user of such a
device to adjust the same.
[0167] Furthermore, and as shown in FIG. 21, restraining device 10
may have a cover flap 2012 positioned thereon to assist maintaining
the placement of restraining device 10 about stomach 100. Cover
flap 2012, as shown in FIG. 21, may be ultimately coupled to first
engaging component 12 and second engaging component 16 (not shown
in FIG. 21), so that after restraining device 10 is positioned
about a stomach 100, cover flap 2012 may be closed (initially
secured to first engaging component 12 and closed by way of
securing cover flap 2012 to second engaging component 16, or vice
versa) about an upper portion of stomach 100.
[0168] As referenced above, restraining device 10 is positioned
about stomach 100 so not to exert pressure upon stomach 100, but
when stomach 100 becomes distended, stomach 100 exerts
pressure/force upon first engaging component 12 and second engaging
component 16 of restraining device 10.
[0169] Steps of a method for delivering and positioning an
embodiment of a restraining device 10, such as the embodiment shown
in FIGS. 20 and 21, are shown in FIG. 22. As shown in FIG. 22,
exemplary method 2200 comprises the step of laparascopically
inserting/advancing restraining device 10 into a patient's body (an
exemplary insertion step 2202). In at least one embodiment, the
restraining device 10 may be inserted through a 15 millimeter
cannula under insufflation into the appropriate cavity of the
patient's body. This may be achieved through use of an exemplary
delivery device known in the art. At step 2202, first swivel arm
2000 and second swivel arm 2002 of restraining device 10 are
swiveled/positioned in the substantially parallel position such
that the overall diameter of the restraining device 10 is
sufficiently narrow for insertion into the body.
[0170] At step 2204, restraining device 10 is advanced to a
location adjacent to a targeted tissue, such as a stomach 100 (an
exemplary advancement step 2204). At step 2206 (an exemplary swivel
step), first swivel arm 2000 and second swivel arm 2002 of
restraining device 10 are swiveled from a substantially parallel
position to a substantially perpendicular position, separating the
first and second engaging components 12, 16 from one another to a
native interior space 70. Step 2206 may be performed using any
number of standard laparoscopic tools known in the art useful to
pull and grasp portions of a tissue or a device. In this manner,
neither the proximal ends 13, 17 nor distal ends 14, 18 of the
first and second engaging components 12, 16 of restraining device
10 are blocked by first swivel arm 2000 and second swivel arm 2002,
and the first and second engaging components 12, 16 may be advanced
over a targeted tissue, such as a stomach 100.
[0171] At step 2208, and under fluoroscopy, direct camera control
or otherwise, restraining device 10 is positioned over the targeted
tissue (an exemplary positioning step). In at least one embodiment,
and at step 2206, the first side 12A of the first engaging
component 12 is positioned adjacent to the desired surface of the
targeted tissue and the first side 16A of the second engaging
component 16 is positioned adjacent to an opposite side of the
targeted tissue. As the first and second engaging components 12, 16
of the restraining device 10 are positioned adjacent to opposite
sides of the targeted tissue, at this step 2208 the targeted tissue
is positioned within the interior space 70 formed between the first
and second engaging components 12, 16. Further, due to the
configuration and composition of restraining device 10, restraining
device 10 can remain within the patient's body for as long as the
restoration or support treatment delivered thereby is desired.
[0172] After restraining device 10 is positioned about a targeted
tissue (by way of performing positioning step 2208), method 2200
may further comprise the optional steps of securing one or more
sutures to connect restraining device 10 to the targeted tissue (an
exemplary suturing step 2210), and may further comprise the step of
securing cover flap 2012 to further secure restraining device about
the targeted tissue (an exemplary cover flap step 2212). In
addition, and as shown in FIG. 22, method 2200 may further comprise
the step of adjusting tape 2026 to control/adjust the interior
space 70 between the first engaging component 12 and the second
engaging component 16 whereby at least a portion of the targeted
tissue is positioned therebetween (an exemplary tape adjustment
step 2214).
[0173] In the exemplary embodiment of a restraining device 10, as
shown in FIG. 23, restraining device 10 comprises one or more
adjustment rods 2300 coupled to the first swivel arm 2000 and the
second swivel arm 2002. In the embodiment shown in FIG. 23, for
example, adjustment rods 2300 are coupled to first swivel arm 2000
and second swivel arm 2002 at or near bends 2020, 2022, and are
further coupled to a first interconnection arm 2016 and a second
interconnection arm 2018, respectively. As shown in FIG. 23, at in
at least one embodiment, adjustment rods 2300 are coupled to first
swivel arm 2000 and second swivel arm 2002 through swivel arm
apertures 2302 defined therethrough, and are further coupled to
first interconnection arm 2016 and second interconnection arm 2018
through interconnection arm apertures 2304 defined
therethrough.
[0174] Adjustment rods 2300, as shown in FIGS. 23 and 25, further
comprise a bar 2306 coupled to adjustment rods 2300 at or near a
distal end 2308 of adjustment rod 2300. Bar 2306, as shown in FIG.
24, is positioned distal to first interconnection arm 2016/second
interconnection arm 2018, so that adjustment of a dial 2310 coupled
to adjustment rod 2300 causes movement of first engaging component
12 and second engaging component 16 toward or away from one
another. As shown in FIG. 24, first interconnection arm 2016 and
second interconnection arm 2018, in various embodiments, may extend
either completely or substantially along the length of first swivel
arm 2000 and second swivel arm 2002 distal to first interconnection
arm 2016 and second interconnection arm 2018, so that adjustment of
dial 2310 facilitates movement of first swivel arm 2000 and second
swivel arm 2002, thus facilitating movement of first engaging
component 12 and second engaging component 16.
[0175] As shown in FIGS. 23-25, adjustment rod 2300 may further
comprise a cap 2312 coupled thereto at or near a proximal end 2314
of adjustment rod 2300. Cap 2312, as shown in FIGS. 23-25, may
prevent dial 2310 from disengaging adjustment rod 2300 so that when
restraining device 10 is positioned within a body, dial 2310
remains upon restraining device 10. Cap 2312, in at least one
embodiment, may be bulbous/rounded at one end for comfort when
restraining device 10 is positioned within a body.
[0176] As shown in FIG. 24, dial 2310 may facilitate adjustment of
device 10 by way of threads 2316 positioned along adjustment rod
2300. In such an embodiment, rotation of dial 2310 in a first
direction would cause first engaging component 12 and second
engaging component 16 to move toward one another, and rotation of
dial 2310 in a second/opposite direction would cause first engaging
component 12 and second engaging component 16 to move away from one
another. As such, restraining device 10 may be positioned within a
body about a stomach, for example, and be adjusted using dial 2310
so that restraining device 10 is optimally positioned about the
stomach.
[0177] As shown in the exemplary embodiments in FIGS. 25 and 26,
dial 2310 may define a dial aperture 2318, whereby indicia 2320
upon adjustment rod 2300 may be viewed therethrough. As shown in
FIG. 26, for example, as dial 2310 is rotated, one or more indicia
2320 may be visible through dial aperture 2318, so that a user of
such an embodiment of a restraining device 10 of the present
disclosure may identify a level of adjustment. Indicia 2320 may be
one or more numbers, letters, lines and/or other indicia 2320
useful to identify a level of adjustment of restraining device
10.
[0178] As shown in FIG. 27, and in at least one embodiment of a
restraining device 10 of the present disclosure, restraining device
10 further comprises at least one flange 2700 coupled to first
swivel arm 2000 and/or second swivel arm 2002. Flange 2700 defines
an aperture therethrough so that adjustment rod 2300 may fit
therethrough, providing physical support for dial 2310 as dial 2310
engages said flange 2700.
[0179] An exemplary embodiment of a restraining device 10 of the
present disclosure having adjustment rods 2300 is shown in FIG. 28.
As shown in FIG. 28, first engaging component 12 and/or second
engaging component 16 may define one or more facets 2800 along at
least part of the length of said components 12, 16, whereby facets
2800 provide a generally arcuate profile as shown therein. Facets
2800 may further improve the overall comfort of restraining device
10 when it is positioned with a patient's body.
[0180] Steps of a method for delivering and positioning an
embodiment of a restraining device 10, such as the embodiment shown
in FIG. 23, are shown in FIG. 29. As shown in FIG. 29, exemplary
method 2900 comprises the step of laparascopically
inserting/advancing restraining device 10 into a patient's body (an
exemplary insertion step 2202) as previously discussed herein. At
step 2202, first swivel arm 2000 and second swivel arm 2002 of
restraining device 10 are swiveled/positioned in the substantially
parallel position such that the overall diameter of the restraining
device 10 is sufficiently narrow for insertion into the body.
[0181] At step 2204, restraining device 10 is advanced to a
location adjacent to a targeted tissue, such as a stomach 100 (an
exemplary advancement step 2204). At step 2206 (an exemplary swivel
step), first swivel arm 2000 and second swivel arm 2002 of
restraining device 10 are swiveled from a substantially parallel
position to a substantially perpendicular position, separating the
first and second engaging components 12, 16 from one another to a
native interior space 70 as previously discussed herein.
[0182] At step 2208, and under fluoroscopy, direct camera control
or otherwise, restraining device 10 is positioned over the targeted
tissue (an exemplary positioning step) as previously referenced
herein. After restraining device 10 is positioned about a targeted
tissue (by way of performing positioning step 2208), method 2900
may further comprise the optional steps of securing one or more
sutures to connect restraining device 10 to the targeted tissue (an
exemplary suturing step 2210), and regarding an embodiment of
restraining device 10 of the present disclosure comprising a cover
flap 2012, method 2900 may further comprise the step of securing
cover flap 2012 to further secure restraining device about the
targeted tissue (an exemplary cover flap step 2212). In addition,
and as shown in FIG. 29, method 2900 may further comprise the
optional step of rotating dial 2310 to control/adjust the interior
space 70 between the first engaging component 12 and the second
engaging component 16 whereby at least a portion of the targeted
tissue is positioned therebetween (an exemplary dial adjustment
step 2902).
[0183] An additional embodiment of a restraining device 10 of the
present disclosure is shown in FIGS. 30 and 31. As shown in FIGS.
30 and 31, restraining devices 10 each comprise a first engaging
component 12 and a second engaging component 16, such as those
provided in various other embodiments herein. First engaging
component 12 and second engaging component 16, in such exemplary
embodiments, are positioned relatively parallel to one another. A
first swivel arm 2000 and a second swivel arm 2002 are pivotally
connected to first engaging component 12 and second engaging
component 16, so that first swivel arm 2000 engages first engaging
component 12 at pivot point 2004 and engages second engaging
component 16 at pivot point 2006, and so that second swivel arm
2002 engages first engaging component 12 at pivot point 2008 and
engages second engaging component 16 at pivot point 2010. First
swivel arm 2000 and second swivel arm 2002 may swivel in the
directions shown in arrows A and B in FIGS. 30 and 31, noting that
first swivel arm 2000 and second swivel arm 2002 may move in
opposite directions, so that one moves in the direction of arrow A
and the other moves in the direction of arrow B.
[0184] As shown in FIGS. 30 and 31, first swivel arm 2000 may
comprise a first arm member 3000 and a second arm member 3002, and
second swivel arm 2002 may comprise a first arm member 3020 and a
second arm member 3022. First arm members 3000, 3020 and second arm
members 3002, 3022 may each couple to a hub 3004, 3024 as shown in
FIGS. 30 and 31. In at least one embodiment, and as shown in FIGS.
30 and 31, second arm members 3002, 3022 may be fixedly coupled to
hubs 3004, 3024, and first arm members 3000, 3020 may slidingly
engage said hubs 3004, 3024, whereby portions of first arm members
3000, 3020 are positioned between hubs 3004, 3024 and hub brackets
3006, 3026. First arm members 3000, 3020 may each have at least one
bend 3008, 3028 therein, as shown in FIGS. 30 and 31, to facilitate
said engagement of first arm members 3000, 3020 to hubs 3004, 3024.
First arm members 3000, 3020, in at least one embodiment, are
capable of movement relative to hubs 3004, 3024 in the directions
shown in arrows C and D in FIGS. 30 and 31, whereby first arm
members 3000, 3020 move in a first direction until they contact
hubs 3004, 3024, for example, and move in a second direction until
arm flanges 3010, 3030 of first arm members 3000, 3020 contact hub
brackets 3006, 3026, for example. First arm members 3000, 3020 and
second arm members 3002, 3022 may be referred to as "fixed arms" if
they are fixed to one of hubs 3004, 3024, and may be referred to as
"expandable arms" if they are coupled to hubs 3004, 3024 by way of
hub brackets 3006, 3026 to facilitate movement relative
thereto.
[0185] In at least one embodiment of an exemplary restraining
device 10 of the present disclosure, and as shown in FIGS. 30 and
31, hub brackets 3006, 3026 may be coupled to hubs 3004, 3024 by
way of one or more fasteners 3012, such as one or more screws,
pins, rivets, and the like Similarly, second arm members 3002, 3022
may be coupled to hubs 3004, 3024 by way of one or more fasteners
3012. In at least one embodiment, first arm members 3000, 3020
and/or second arm members 3002, 3022 are comprised of stainless
steel (such as 316LVM, or implant-grade stainless steel) hubs 3004,
3024 are comprised of one or more polyaryletherketones (PEEKs), and
hub brackets 3006, 3026 are also comprised of stainless steel.
First engaging component 12 and second engaging component 16 may,
in at least one embodiment, comprise stainless steel which may then
be coated/overmolded with a biocompatible polymer, such as
polyurethane (PX205, for example) or tecothane (TT-1075D-M, for
example).
[0186] In various embodiments of restraining devices 10 of the
present disclosure, restraining devices 10 may comprise one or more
pads 3014, 3034 coupled to first arm members 3000, 3020 and/or
second arm members 3002, 3022. Said pads 3014, 3034 may comprise
any number of biocompatible polymers and/or other materials that
are suitable for contacting an organ, such as a stomach, and which
may provide some sort of cushioning effect. In at least one
embodiment, pads 3014, 3034 may be comprised of a biocompatible
polymer such as carbothane (such as PC-3595A), for example, and may
be coupled to first arm members 3000, 3020 and/or second arm
members 3002, 3022 using one or more fasteners 3012. In at least
one embodiment, fasteners 3012, as referenced herein, may be
comprised of stainless steel.
[0187] Regarding the exemplary embodiment of restraining device 10
shown in FIGS. 30 and 31, restraining device is shown in an open
configuration in FIG. 30 and in a closed configuration in FIG. 31.
As shown in FIG. 31, an exemplary restraining device 10 of the
present disclosure may comprise a strap 3100 coupled thereto at
first engaging component 12 and second engaging component 16. In at
least one embodiment, strap 3100 is fixedly coupled to one or both
of first engaging component 12 and second engaging component 16,
and in another embodiment, strap is removably coupled to one or
both of first engaging component 12 and second engaging component
16 by way of one or more sutures 32 (such as a 2-0 silk suture, for
example), as shown in FIG. 31. As shown in the embodiment of
restraining device 10 in FIG. 31, a first end 3102 of strap 3100 is
fixedly coupled to second engaging component 16, and a second end
3104 of strap 3100 is removably coupled to first engaging component
12 by way of suture 32. In practice, suture 32 may not be
positioned within suture aperture(s) 34 defined within one or more
components of restraining device 10 until after restraining device
10 has been inserted into a mammalian body. In at least one
embodiment, one or more suture apertures 34 defined within one or
more components of restraining device 10 may comprise/define one or
more eyelets 3106, whereby said eyelets 3106 provide additional
reinforcement/strength, and may also provide a more smooth, rounded
contour than suture apertures 34 so not to cause unintended wear,
and potential breakage, of one or more sutures 32 positioned
therethrough. In at least one embodiment, strap 3100 comprises
carbothane (PC-3595A), and eyelets 3106 are comprised of nickel. In
at least another embodiment, strap 3100, or portions thereof, may
be radiopaque.
[0188] FIGS. 32 and 33 show top views of exemplary restraining
devices 10 of the present disclosure. As shown in FIG. 32,
restraining device 10 is shown with first swivel arm 2000 and
second swivel arm 2002 in a positioned whereby said arms 2000, 2002
are at least substantially perpendicular to first engaging
component 12. As shown in FIG. 32, and in at least one embodiment
of a restraining device 10 of the present disclosure, first swivel
arm 2000 is relatively shorter than second swivel arm 2002, whereby
such a configuration allows for placement of restraining device 10
about a stomach, for example, as shown in FIGS. 40, 41, and 42.
[0189] FIG. 33 shows an exemplary restraining device 10 whereby
first swivel arm 2000 and second swivel arm 2002 share a common
linear axis with first engaging component 12. In the configuration
shown in FIG. 33, for example, restraining device 10 may fit within
a bodily laparoscopic port for eventual swiveling of arms 2000,
2002 and placement of restraining device 10 about an organ. FIG. 34
shows a front view of an exemplary restraining device 10 of the
present disclosure in a similar configuration as shown in FIG. 33,
and FIG. 35 shows a perspective view of restraining device 10 in
the same configuration.
[0190] FIGS. 36 and 37 show a side view and a perspective view,
respectively, of an exemplary first swivel arm 2000 of the present
disclosure. In at least one embodiment, and as shown in FIG. 36,
first swivel arm 2000 has an interior length (as indicated by arrow
A in the figure) of about 26.5 mm, and has an expanded interior
height (as indicated by arrow B in the figure) of about 19.1 mm. In
other embodiments, the interior length and interior height may be
greater or lesser than those shown in the figure.
[0191] As shown in FIGS. 36 and 37, an exemplary first swivel arm
2000 may have one or more distal arm flanges 3600, which, in at
least one embodiment, are bent relatively down/up and then out, as
shown in the figures, so that exemplary first swivel arm 2000 may
engage first engaging component 12 and second engaging component 16
while maintaining integrity of first swivel arm 2000 and/or
providing additional clearance for an organ positioned
therebetween. In at least one embodiment, and as shown in FIG. 36,
distal arm flanges 3600 result in an expanded flange height (as
indicated by arrow C in the figure) of less than the expanded
interior height. The relative distal ends of first swivel arm 2000,
which may themselves comprise distal arm flanges 3600, may comprise
one or more arm apertures 3602 configured to receive, for example,
one or more rivets 3604 (as shown in FIGS. 30 and 31) therethrough
to couple first swivel arm 2000 to a first engaging component 12
and a second engaging component 16. In at least one embodiment,
rivets 3604 are comprised of stainless steel. In at least another
embodiment, another type of fastener 3012, as described herein,
aside from a rivet 3604 may be used.
[0192] FIGS. 38 and 39 show a side view and a perspective view,
respectively, of an exemplary second swivel arm 2002 of the present
disclosure. In at least one embodiment, and as shown in FIG. 38,
second swivel arm 2002 has an interior length (as indicated by
arrow A in the figure) of about 37 mm, and has an expanded interior
height (as indicated by arrow B in the figure) of about 18 mm. In
other embodiments, the interior length and interior height may be
greater or lesser than those shown in the figure.
[0193] As shown in FIGS. 38 and 39, an exemplary second swivel arm
2002 may also have one or more distal arm flanges 3600, which, in
at least one embodiment, are bent relatively down/up and then out,
as shown in the figures, so that exemplary second swivel arm 2002
may engage first engaging component 12 and second engaging
component 16 while maintaining integrity of second swivel arm 2002
and/or providing additional clearance for an organ positioned
therebetween. In at least one embodiment, and as shown in FIG. 38,
distal arm flanges 3600 result in an expanded flange height (as
indicated by arrow C in the figure) of less than the expanded
interior height. The relative distal ends of second swivel arm
2002, which may themselves comprise distal arm flanges 3600, may
comprise one or more arm apertures 3602 configured to receive, for
example, one or more rivets 3604 (as shown in FIGS. 30 and 31)
therethrough to couple second swivel arm 2002 to a first engaging
component 12 and a second engaging component 16.
[0194] FIG. 40 shows an exemplary embodiment of a restraining
device 10, such as shown in FIGS. 30 and 31, positioned about a
stomach. As shown in FIG. 40, device 10 may be positioned about
stomach 100 similar to placement of restraining device 10 about
stomach 100 as shown in FIGS. 5B and 21, for example, so that the
first engaging component 12 (not shown in FIG. 40) and the second
engaging component 16 may engage opposite sides of stomach 100.
Restraining device 10 may be secured to stomach 100 using one or
more sutures 34 to couple restraining device 10 to stomach 100, or
one or more sutures 34 may be positioned within suture aperture(s)
34 within strap 3100 and one or both of first engaging first
engaging component 12 and second engaging component 16 to secure
restraining device 100 about a stomach 100. FIGS. 41 and 42 show
additional views of an exemplary restraining device 10 positioned
about a stomach 100.
[0195] An exemplary embodiment of a restraining device 10 of the
present disclosure is shown in FIG. 43. As shown therein,
restraining device 10 comprises a first c-ring 4300 (which may also
be referred to herein as an inferior c-ring (and also whereby the
various c-rings 4300 or other c-rings of the present disclosure may
be exemplary swivel arms 2000, 2002 or other couplers used to
couple two engaging components 12, 16 of the present disclosure to
one another, as generally described and shown herein)), whereby an
inferior c-ring 4300 is relatively rigid and load-carrying in
various embodiments, and whereby a superior c-ring 4400 (shown in
FIG. 44), in various embodiments, is relatively rigid on one axis
and flexible on another axis. Engaging components 12, 16 may be
relatively stiff and coated with some sort of coating 4302 (such as
an elastomer coating or other coating) as tissue interface
material. The flexible coating 4302 can be flexible around the
relative edges of the engaging components 12, 16, and excess
flexible coating 4302, extending sufficiently from the inner rigid
plates 4312 and 4316, as shown in FIG. 43, can gradually distribute
any forces of the plates to the tissue (such as the stomach). The
coating 4302 (which may also be referred to as a mattress or
cushion) also helps prevent shearing and migration of the device 10
with respect to the device 10 rubbing against the tissue or organ.
As shown in FIG. 43, for example, coating 4302 extends beyond a
perimeter 4530 of each rigid plate 4312, 4316. As the stomach 100
distends, for example, when an exemplary device 10 of the present
disclosure is positioned therein, stomach tissue 100 can "roll"
relative to coating 4302, preventing migration of portions of
device 10 into stomach 100 tissue.
[0196] Engaging components 12, 16 may also each comprise a tail
4322, 4326 at one end that is relatively flexible and generally
comprising a coating material 4302 and not any sort of rigid
material (such as used with rigid plates 4312, 4316) therein. The
tails 4322, 4326 are shown in FIG. 43. The strap 3100 (also
referred to herein as a "fundus strap") shown therein may comprise
an embedded, load-carrying element (rigid inner portion 4500)
inside of a silicone coating (an exemplary coating 4302). For
example, nylon, PEEK mesh, and stainless steel foil can each be
exemplary embedded elements 433) within a coating 4302 and still
operate as a fundus strap 3100 consistent with the present
disclosure. After the device 10 is positioned about a stomach 100
and a fundus strap 3100 wrapped around an upper portion of the
stomach 100 (such as from behind stomach 100) and locked into
place, excess fundus strap 3100 may be cut off. The fundus strap
3100 can be coupled to the anterior engaging component 16 and lock
onto the other engaging component 12. A hook or other mechanism (an
exemplary tab 4600, as shown in FIG. 46) may be used to lock a
portion of the fundus strap 3100 to the plate (engaging component
12 or 16) that does not have the fundus strap 3100 initially
coupled thereto. Use of a fundus strap 3100, in various
embodiments, is also to effectively exclude the fundus 90 region
from the flow of food into the stomach 100, further directing food
to the channel (such as first stomach portion 110 referenced
herein) created using the device 10 and not to the fundus 90 area.
Regarding overall load-carrying, at least one purpose of using
metal (or another rigid material) within the flexible/pliable
coating 4302 (such as silicone) is to provide additional strength
and also to limit stretch of the portion of device 10 (engaging
components 12 and/or 16, fundus strap 3100, and/or c-arms, c-rings
4300 or 4400, or other connectors), so that the same do not distend
over time. As referenced herein, such a rigid material can be used
with rigid inner plate 4312 and/or 4412 and/or other components as
referenced herein.
[0197] Each c-ring 4300, 4440 may have one, two, or three or more
suture features 4402 (such as and/or similar to suture members 36
having suture apertures 32, for example, or other types of suture
features) therein as shown in FIG. 44, such as one at a relative
apex (middle) of one or both c-rings 4300, 4400, and one between
the apex and one end on an anterior side of the device 10 when
viewed as positioned upon a stomach 100. Suture features 4402 would
allow one or more sutures 34 (also referred to herein as strings
34) to pass therethrough. The engaging components 12, 16 may
comprise a stiff inner portion (namely rigid inner plates 4312,
4316, comprising material such as metal) and a flexible or
compressible outer coating 4302, such as silicone. Various holes
4350 can be defined within the engaging components 12, 16 or within
rigid inner plates 4312, 4316 as shown in FIG. 43, or a fundus
strap 3100 stiff inner portion, which can reduce the weight of the
device 10 and allow the coating 4302 material to enter the holes
4350 and help with overall binding of the coating 4302 to said
components.
[0198] The c-rings 4300, 4400 can swivel about engaging components
12, 16, such as about 90.degree., less, or more. Optional stops
4410 positioned on an engaging component 12 and/or 16 can be used
to prevent c-rings 4300, 4400 from swiveling further than
desired.
[0199] A superior c-ring 4400 and/or an inferior c-ring 4300 can
have one or more suture holes (such as suture apertures 32 of
suture members 36 and/or suture features 4402) to allow sutures 34
to connect the device 10 to the stomach 100. The superior c-ring
4400 and/or the inferior c-ring 4300 can have an insert 4420, which
can be flexible and/or metal, surrounded by silicone or another
flexible/pliable material (such as coating 4302) for tissue
contact. Rivet holes 4430 can be defined at the relative ends of
the superior c-ring 4400 to fasten the same to the engaging
components 12, 16. The same or different coating 4302 can be used
to coat/surround rigid inner plate 4312, 4316, and/or metal
insert(s) 4420.
[0200] The superior c-ring 4400 and/or the inferior c-ring 4300 can
be flexible in one plane but not two planes. For example, and as
shown in FIG. 44, c-ring 4400 can be relatively stiff when pushed
in a direction shown by arrow "A", and can be relatively flexible
when pushed in a direction shown by arrow "B".
[0201] Distal portions of exemplary fundus straps 3100 are shown in
FIGS. 45A, 45B, and 45C. As shown in FIG. 45A, distal portion of
fundus strap 3100 has a rigid inner portion 4500 (such as metal)
and optionally one or more apertures 4502 or ridges 4504 defined
therein, allowing a flexible polymer outer coating 4302 to better
adhere and remain in contact with the rigid inner portion 4500. An
optional inner mesh 4510 (such as a nylon mesh), as shown in FIG.
45B, can be embedded within the flexible polymer outer coating 4302
to provide additional support to the distal end of the fundus strap
3100. A portion of the rigid inner portion 4500/mesh 4510 may have
a mesh aperture 4512 defined therein, as shown in FIG. 45C, whereby
a portion of the inner mesh 4510 can be positioned therethrough to
further hold the mesh 4510 in place. The various inner portion
apertures 4502, ridges 4504, and mesh apertures 4512 can be laser
welded, for example.
[0202] FIG. 46 shows ends of two engaging components 12, 16, with
one having a fundus strap 3100 coupled thereto. The engaging
component 12 or 16 that does not have the fundus strap 3100 coupled
thereto (engaging component 12, for example, as shown in FIG. 46),
and in at least one exemplary device 10 embodiment of the present
disclosure, has a loop 4602 and an optional tab 4600 coupled
thereto, whereby the loop 4602 defines an opening 4604 sized and
shaped to receive a portion of the fundus strap 3100 thereto, and
wherein the fundus strap 3100 defines one or more tab apertures
4610 configured to receive the tab 4600. Use of the loop 4602
and/or tab 4600 can secure the end of the fundus strap 3100 to the
other engaging component (such as engaging component 12, as shown
in FIG. 46). In use, the end of the fundus strap 3100 can be
positioned in the loop opening 4604 and either pushed or pulled
therethrough until a desired amount of connection is obtained, and
further locked into place using tab 4600 and tab aperture 4610. Tab
4600 can be angled or otherwise configured to receive and secure
the fundus strap 3100. The loop 4602 can be made of metal or
plastic. One of the purposes of such a design, and other designs of
the present disclosure, is to aid in laparoscopic placement and
ease of handling and placement for the physician placing the device
10 within the patient.
[0203] In various device 10 embodiments of the present disclosure,
relatively rectangular c-rings 4300, 4400 can fit through a 15mm
trocar and carry the necessary load to maintain a desired engaging
component gap. For example, FIGS. 47A and 47B show portions of
exemplary restraining devices 10, whereby one or both c-rings 4300,
4310 (one c-ring (4300 chosen for example) shown therein) has/have
a first c-ring portion 4700 and a second c-ring portion 4702
connected at a pivot point 4704 using a coupler 4706. Such an
embodiment allows the first c-ring portion 4700 to pivot relative
to the second c-ring portion 4702 to reduce an overall
cross-sectional size of the device 10, such as from changing from a
relatively open swivel configuration shown in FIG. 47A to a
relatively closed swivel position shown in FIG. 47B.
[0204] FIGS. 48A and B shows another embodiment of a portion of a
device 10, whereby one or both c-rings 4300, 4400 (one shown,
namely 4300 for example, in FIGS. 48A and 48B) are configured to
expand from a relatively closed configuration (FIG. 48A), such as
for delivery through a trocar, to a relatively open configuration
(FIG. 48B), for placement about a stomach 100. In such an
embodiment, the c-rings 4300, 4400 may have a first c-ring portion
4700 and a second c-ring portion, and one portion (such as, for
example, second c-ring portion 4702 shown in FIG. 48B) may have a
c-ring post 4800, and the other portion (such as, for example,
first c-ring portion 4700 shown in FIG. 48B) may have a c-ring post
aperture 4802 to receive the post 4800, allowing for such an
expansion to occur.
[0205] A slider coupler 4900, such as shown in FIGS. 49A and 49B,
may also be used in connection with first and second c-ring
portions. As shown in FIG. 49A, slider coupler 4900 is configured
to receive, and slidingly engage, and retain (at least temporarily)
at least one of the first ring portion 4700 and/or the second
c-ring portion 4702, allowing one or both to move in the relative
directions shown by the bold arrows in the figure. One or both
c-ring portions (such as the second c-ring portion 4702 shown in
FIG. 49B) can be separate from slider coupler 4900 and positioned
therein after delivery through the trocar. An engagement mechanism
4902 within slider coupler 4902 or coupled to a c-ring 4300 can be
used to maintain engagement of one or both c-rings 4300, 4400
within slider coupler 4900.
[0206] FIG. 50A shows yet another embodiment of portions of an
exemplary c-ring 4300, 4400 (with first c-ring 4300 shown in the
figure), whereby a first c-ring portion 4700 is coupled to, or
forms a portion of, a joiner 5000, with said joiner 5000 defining
an inner threaded portion 5002 therein. The inner threaded portion
5002 would be configured to receive an outer threaded portion 5004
of a second c-ring portion 4702, either by twisting the joiner 5000
or one of the c-rings 4300, 4400, or by pushing the c-rings 4300,
4400 toward one another. Another mechanism for coupling two c-ring
portions 4300, 4400 to one another may be, as shown in FIG. 50B, by
defining a c-ring stub aperture 5050 (which may also be referred to
as a tab aperture) in one and having a c-ring stub 5052 (which may
also be referred to as a tab) extending from another, the c-ring
stub aperture 5050 configured to receive the c-ring stub 5052. Once
coupled together, a cover 5060 (such as a tubing portion, for
example) could be placed around the two c-ring portions 4300, 4400
to further hold the two portions 4300, 4400 together.
[0207] FIGS. 51A and 51B show c-ring portions 4700, 4702 having a
two-part hinge 5100 therein, whereby pivot points 5102 defined
therein allow one c-ring portion 4700 to pivot about a second
c-ring portion 4702 at two locations, allowing a portion of device
10 to move from a relatively closed configuration (shown in FIG.
51A) to a relatively open configuration (shown in FIG. 51B), in a
direction shown by the bold arrow in FIG. 51B. Another embodiment,
shown in FIGS. 52A and 52B, show c-ring portions 4300, 4400 (with
c-ring portion 4300 shown in the figures) connected to one another
by way of a hinge unit 5200 configured to swivel about two pivot
points 5102 so that the device 10 can move from a relatively open
configuration (shown in FIG. 52A) to a relatively closed
configuration (shown in FIG. 52B).
[0208] FIGS. 53A and 53B show an exemplary elongated coupler 5300
of the present disclosure with two living hinges 5302 defined
therein. Living hinges 5302 allow the elongated coupler 5300 to
flex in various ways, from a relatively straight configuration
shown in FIG. 53A, to a relatively closed configuration in FIG.
53B, shown in FIG. 53B as coupled to a second elongated coupler
5310. A first coupler slot 5304 defined within the first elongated
coupler 5300 can allow a portion of the second elongated coupler
5310 to pass therethrough, and a second coupler loop 5312 can be
configured to receive a portion of the first elongated coupler
5300. Elongated couplers 5300, 5310, can connect to engaging
components 12, 16.
[0209] The different configurations shown in FIGS. 47A-53B are
intended, in various embodiments, to alter a cross-sectional size
of the device 10 so that the relative cross-sectional size is
smaller during delivery of the device 10 into a patient and larger
when the device 10 is positioned around part of a stomach 100 or
other bodily tissue.
[0210] FIG. 54 shows yet another device 10 embodiment of the
present disclosure, whereby the one of the engaging components 12,
16 (shown as first engaging component 12) loops around and couples
to the other engaging component (shown as second engaging component
16). A component tab 5400 defined at one end of the first engaging
component 12 may optionally engage a tab receiver 5402 of the
second engaging component 16 to couple the two engaging components
12, 16 to one another.
[0211] FIGS. 55A and 55B show cross-sectional end views of
exemplary engaging components of the present disclosure. FIG. 55A
shows a cross-sectional end view of an exemplary engaging component
12, with first side 12A (the side that would contact a tissue, such
as stomach 100) shown on the bottom and second side 12B (the side
that would not contact a tissue) shown at the top. As shown
therein, lobes 5500 of coating 4302 can be formed/present at the
relative sides 5502 of engaging component 12, with lobes 5500
having a relatively larger cross-section 5504 than another portion
of component 12, such as necks 5506 adjacent to lobes 5500, which
have a relatively smaller cross-section 5508. Exemplary engaging
components 12 of the present disclosure can also comprise a
protrusion 5508, positioned at or near first side 12A, configured
to provide additional potential comfort to a user of device 10.
FIG. 55B shows a cross-sectional end view of an exemplary engaging
component 16, with first side 16A (the side that would contact a
tissue, such as stomach 100) shown on the bottom and second side
16B (the side that would not contact a tissue) shown at the top. As
shown therein, lobes 5500 of coating 4302 can be also
formed/present at the relative sides 5502 of engaging component 12
adjacent to necks 5506 as shown therein. Lobes 5500, as shown in
FIG. 55B, may extend toward first side 16A, noting the difference
between lobes 5500 shown in FIG. 55A, which extend away from first
side 12A. Exemplary engaging components 16 of the present
disclosure can also comprise a protrusion 5508, positioned at or
near first side 16A, configured to provide additional potential
comfort to a user of device 10.
[0212] Various c-rings, c-arms, couplers, and/or swivel arms
described herein and/or shown in the figures may relate to the same
type of componentry, so features described for one may apply to the
others in various embodiments.
[0213] The various embodiments of restraining devices 10 described
herein provide numerous benefits over the devices and systems of
the prior art. An exemplary restraining device 10 may be inserted
laparoscopically and/or endoscopically, is minimally invasive,
completely reversible and available for chronic placement without
the risk of complications. Furthermore, use of a restraining device
10 to treat and/or support a targeted tissue or organ produces a
reduced amount of negative side effects than the procedures of the
prior art for similar indications. While embodiments of restraining
devices 10 are presented with respect to specific anatomy and
treatment examples, the various restraining devices 10 and methods
300 may be expanded for use in treating any organ, limb or body
structure that would benefit from reshaping, restoring, or added
support provided through a reversible, easy to use and easy to
implement technique for chronic placement.
[0214] Prior art focuses on creating a restrictive line through
"clamps" to mimic the gastric sleeve. The disclosure of the present
application provides various loosely-fitting restraints (to prevent
migration) and to affect motility of the stomach 100. The
contractility or motility curve of the gastric tissue is
substantially attenuated by an external restraint (as discussed
below), thus affecting the movement of bolus through the stomach
100. Hence, the food volume will remain in the pouch longer and
lead to earlier distension which affects neuroactivity and
mechanosensory elements of satiety. Hence, the principle of the
restraining devices 10 of the present disclosure is based on flow
(motility) unlike previous art that focuses on restrictive which
risks migration and erosion.
[0215] As described herein, placement of exemplary restraining
devices 10 through the lower curvature can be easily implemented as
opposed to procedures which approach the greater curvature where
the liver and diaphragm are in the proximity. Furthermore, various
clips, clamps, or perforated plates known in the art which
transverse the stomach 100 (as opposed to sleeve) can lead to
substantial remodeling of the fundus which would lead to weight
regain after a period of time. As such, the various connectors of
the disclosure of the present application operate to prevent
overall stretch of stomach 100 and hence prevent remodeling. The
stretch that leads to mechanosensory satiety in the restraining
devices 10 of the present disclosure occurs locally between the
restraining springs or bars while still restraining the overall
pouch. No such global containment of the gastric tissue is known in
the prior art. Finally, various clips, clamps, or perforated plates
known in the art would exert significant local stresses on the
tissue which can lead to erosion or migration as the substantially
restricted stomach 100 would attempt to distend. Conversely, the
first engaging component 12 and the second engaging component 16 of
the restraining devices 10 of the present disclosure distribute the
stress more uniformly over the plate and only restrain a relatively
small pouch rather than a more substantial portion of the stomach
100 transversely.
[0216] While various embodiments of implantable restraining
devices, systems, and methods for using the same have been
described in considerable detail herein, the embodiments are merely
offered by way of non-limiting examples of the disclosure described
herein. It will therefore be understood that various changes and
modifications may be made, and equivalents may be substituted for
elements thereof, without departing from the scope of the
disclosure. Indeed, this disclosure is not intended to be
exhaustive or to limit the scope of the disclosure.
[0217] Further, in describing representative embodiments, the
disclosure may have presented a method and/or process as a
particular sequence of steps. However, to the extent that the
method or process does not rely on the particular order of steps
set forth herein, the method or process should not be limited to
the particular sequence of steps described. Other sequences of
steps may be possible. Therefore, the particular order of the steps
disclosed herein should not be construed as limitations of the
present disclosure. In addition, disclosure directed to a method
and/or process should not be limited to the performance of their
steps in the order written. Such sequences may be varied and still
remain within the scope of the present disclosure.
* * * * *