U.S. patent application number 12/175242 was filed with the patent office on 2009-01-22 for endoscopic implant system and method.
Invention is credited to Samuel T. Crews, Justen England, Bretton Swope.
Application Number | 20090024143 12/175242 |
Document ID | / |
Family ID | 39790434 |
Filed Date | 2009-01-22 |
United States Patent
Application |
20090024143 |
Kind Code |
A1 |
Crews; Samuel T. ; et
al. |
January 22, 2009 |
ENDOSCOPIC IMPLANT SYSTEM AND METHOD
Abstract
Disclosed is a system for endoscopically implanting a medical
implant within a body cavity such as a human stomach. The system
includes one or more anchors positionable within one or more
openings formed in tissue within the body cavity, such as cutouts
formed in plicated body tissue. Tools are disclosed for positioning
the anchors within the openings, and for coupling the implant to
the anchors.
Inventors: |
Crews; Samuel T.; (Woodside,
CA) ; Swope; Bretton; (Gaithersburg, MD) ;
England; Justen; (San Francisco, CA) |
Correspondence
Address: |
STALLMAN & POLLOCK LLP
353 SACRAMENTO STREET, SUITE 2200
SAN FRANCISCO
CA
94111
US
|
Family ID: |
39790434 |
Appl. No.: |
12/175242 |
Filed: |
July 17, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60950584 |
Jul 18, 2007 |
|
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|
61042862 |
Apr 7, 2008 |
|
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Current U.S.
Class: |
606/139 ;
606/167 |
Current CPC
Class: |
A61F 5/0083 20130101;
A61F 5/0086 20130101; A61B 17/0644 20130101; A61F 5/0003 20130101;
A61B 17/0643 20130101; A61B 2017/0647 20130101; A61F 5/0079
20130101; A61F 5/0089 20130101; A61B 17/128 20130101; A61B
2017/00862 20130101 |
Class at
Publication: |
606/139 ;
606/167 |
International
Class: |
A61B 17/122 20060101
A61B017/122; A61B 17/32 20060101 A61B017/32 |
Claims
1. A method of coupling an implant to tissue having an opening
formed therein, the method comprising: providing an anchor having a
head and a base; drawing the head through the opening in the tissue
to position the head on a first side of the plication and the base
on a second side of the plication, and coupling an implant to the
anchor.
2. The method of claim 1, wherein the method includes, after
drawing the head through the opening, expanding the head to a
diameter larger than the diameter of the opening.
3. The method of claim 1, wherein drawing the head deforms the head
for passage through the opening, an wherein expanding the head
includes allowing the head to assume the larger diameter.
4. The method of claim 2, wherein the method includes: coupling the
anchor to a first tool; advancing the first tool into a body
cavity; advancing a second tool into the body cavity and passing
the second tool through the opening; after passing the second tool
through the opening, engaging the anchor using the second tool;
withdrawing the second tool from the opening to draw the head
through the opening; and releasing the anchor from the first
tool.
5. The method of claim 4, wherein coupling the implant to the
anchor includes passing the implant over the second tool and over
the head.
6. The method of claim 2, wherein the method includes coupling a
tool to the head, and wherein coupling an implant to the anchor
includes, with the tool coupled to the head and with a portion of
the anchor disposed in the tissue opening, advancing the implant
over the tool and into engagement with the anchor.
7. The method of claim 6, wherein the implant includes an opening,
and wherein advancing the implant over the tool and into engagement
with the anchor includes threading the opening of the implant onto
the tool and advancing the implant over the tool and the head.
8. The method of claim 1, wherein coupling the implant to the
anchor includes coupling the implant to the anchor after drawing
the head through the tissue opening.
9. The method of claim 4, wherein advancing the first tool into the
body cavity includes advancing the first tool with the anchor
thereon into the body cavity.
10. The method of claim 4, wherein the anchor is coupled to the
first tool after the first tool is advanced into the body
cavity.
11. The method of claim 7, wherein the method includes providing a
plurality of the anchors and drawing the heads of the plurality of
the anchors through a plurality of tissue openings, coupling a
plurality of tools to the heads of the plurality of anchors, and
advancing the implant over the plurality of tools and into
engagement with the anchors.
12. The method of claim 6, wherein the tissue opening is in a
plication extending from a tissue wall and wherein: providing the
anchor includes providing the head to include a laterally-extending
loop the method further includes positioning the anchor within the
tissue opening such that the loop extends generally away from the
most proximate second of the tissue wall.
13. The method of claim 12, wherein: providing the anchor further
includes providing the base to include a first edge having a first
curvature and a second edge having a second, flatter curvature, the
loop extending laterally in a direction opposite to the second edge
of the base, and positioning the anchor includes positioning the
anchor with the second edge in contact with the wall to cause the
loop to extend generally away from the most proximate section of
the tissue wall.
14. The method of claim 12, wherein the tissue opening is in a
plication in a stomach wall, and wherein positioning the anchor
includes transorally introducing the anchor into the stomach and
positioning the anchor with the second edge in contact with the
interior wall of the stomach.
15. The method of claim 1, wherein the tissue opening is in a
plication in a stomach wall, and wherein the method includes
introducing the anchor and the implant transorally into the
stomach.
16. The method of claim 15, wherein the method is further for
forming the opening in the tissue structure, and further includes:
forming a plication in the wall of the stomach; forming an opening
in the plication.
17. The method of claim 16, wherein the method includes introducing
a plication tool transorally into the stomach and forming the
plication with the plication tool.
18. The method of claim 17, wherein the method includes forming the
opening in the plication with the plication tool.
19. A medical implant system for coupling an implant to an opening
formed in body tissue, comprising: an anchor comprising a head
coupled to a base, the head having a first, natural, position in
which the head has a diameter larger than a diameter of the
opening, and a second, elongated, position in which the head is
deformed for passage through the opening; and an implant having an
opening, the opening of the implant proportioned to allow passage
of the head when the head is in the second position, and to resist
passage of the head when the head is in the first position.
20. The medical implant system of claim 19, wherein the anchor head
is moveable from the first position to the second position in
response to application of tension in a generally longitudinal
direction between the head and the base.
21. The medical implant system of claim 19, wherein the anchor head
is moveable to a third position in response to application of
tension to the head in a generally transverse direction, wherein in
the third position the head is proportioned to resist passage
through the opening.
22. The medical implant system of claim 19, wherein the head is
more elastic than the base.
23. The medical implant system of claim 19, wherein the anchor
includes a stem extending between the head and the base.
24. The medical implant system of claim 23, wherein the stem is
more elastic than the base.
25. The medical implant of claim 23, wherein the head includes a
ring coupled to the stem.
26. The medical implant system of claim 25, wherein the ring has an
undulating surface.
27. The medical implant system of claim 25, wherein the head
includes a loop extending laterally from the ring.
28. The medical implant system of claim 23, wherein at least one of
the head and the base is asymmetrical relative to the longitudinal
axis of the stem.
29. The medical implant system of claim 19, wherein the head
includes a laterally-extending loop.
30. The medical implant system of claim 19, wherein the base has a
first edge having a first curvature and a second edge having a
second, flatter curvature.
31. The medical implant system of claim 29, wherein the head has a
loop extending laterally in a direction opposite to the second edge
of the base.
32. The medical implant system of claim 19, wherein the body cavity
is a stomach and the opening is in stomach tissue and wherein the
system further includes a tool proportioned for transoral insertion
into the body cavity and for extension through the opening in the
stomach tissue, the tool engageable with the head to deform the
head into the second position, the opening of the implant slidable
over the tool through an oral cavity into position within the
stomach.
33. The medical implant system of claim 32, wherein the head
includes a loop and wherein the tool is engageable with the
loop.
34. The medical implant system of claim 33, wherein the tool
includes a jaw having an open position and a closed position.
35. The medical implant system of claim 32, wherein: the system
includes a plurality of the anchors; the implant includes a
plurality of openings; and the system includes a plurality of tools
each transorally insertable into the stomach and extendable through
separate openings formed in stomach tissue, each tool engageable
with the head of a corresponding one of the anchors to deform the
head into the second position, the opening of the implant slidable
over the plurality of tools into engagement with the anchors.
36. The medical implant system of claim 32, wherein the system is
further for forming the opening in the stomach tissue, and wherein
the system further includes a plication tool and a tissue cutting
element, wherein the anchor is positionable within an opening
formed by the tissue cutting element in a plication formed by the
plication tool.
37. The medical implant system of claim 36, wherein the tissue
cutting element is on the plication tool.
38. The medical implant system of claim 37, wherein the plication
tool includes a plurality of staples advanceable through tissue for
forming a plication.
39. The medical implant system of claim 19, wherein the implant
comprises a wall bounding an interior, and wherein the opening is
formed in the wall.
40. The medical implant system of claim 39, wherein the implant is
a flow-restrictive implant proportioned for implantation within a
stomach having the tissue opening formed in tissue of the
stomach.
41. The medical implant system of claim 35, further including: an
implant pusher having at least one engaging pin on a distal portion
of the implant pusher, the implant pusher proportioned for
transoral advancement into the stomach with the implant coupled to
the engaging pin.
42. The medical implant system of claim 32, further including
instructions for use instructing the user to implant the anchor and
implant according to the following steps: coupling the anchor to
the tool; transorally advancing the tool into the stomach;
advancing a second tool into the stomach and passing the second
tool through the tissue opening; after passing the second tool
through the opening, engaging the anchor using the second tool;
withdrawing the second tool from the opening to draw the head
through the opening; releasing the anchor from the first tool; and
passing the implant over the second tool and over the head.
43. A restrictive stomach implant, comprising: a wall including a
plurality of anchor points and compliant sections between the
anchor points.
44. The restrictive stomach implant of claim 43, wherein the
compliant sections include at least one fold positioned between
each pair of anchor points.
45. The restrictive stomach implant of claim 43, wherein the wall
is formed of first regions of a first material and second regions
of a second material, the first regions more compliant than the
second regions.
46. The restrictive implant of claim 45, wherein the wall is formed
of the first material, and wherein the second regions include
sections of the second material positioned on the first
material.
47. The restrictive implant of claim 46, wherein the sections of
second material include longitudinal ribs.
48. The restrictive implant of claim 45, wherein the wall includes
a distal orifice, and wherein the sections of second material
include a ring of second material encircling the distal
orifice.
49. The restrictive implant of claim 43, wherein the wall defines a
sleeve having a proximal edge, the proximal edge including
proximally extending peaks.
50. The restrictive implant of claim 49, wherein the peaks define
chutes for directing ingested food material from a proximal portion
of the implant towards a distal portion of the implant.
51. The restrictive implant of claim 43, wherein the wall includes
a distal orifice defined by an edge, wherein the edge includes a
plurality of folds.
52. The restrictive implant of claim 43, wherein the anchor points
comprise a plurality of anchor openings formed in the wall.
53. The restrictive implant of claim 52, wherein each of the anchor
openings includes a circumferential reinforcement.
54. A medical implant system for use in a patient comprising: an
anchor configured to be coupled to tissue within a body cavity; a
first tool having a proximal portion, a distal portion, and a shaft
between the proximal and distal portions, the distal portion
including a coupling element operable to couple the first tool to
the anchor, the first tool proportioned such that when the coupling
element is coupled to the anchor within the body cavity, the
proximal portion of the first tool extends out of the patient; and
an implant having an opening proportioned to slide over the shaft
and distal end of the first tool and into engagement with the
anchor.
55. The medical implant system according to claim 54 wherein the
opening and the first tool are proportioned to allow the opening to
slide over a proximal tip of the first tool.
56. The medical implant system according to claim 55, wherein the
proximal tip is tapered in a proximal direction.
57. The medical implant system according to claim 54, further
including a second tool having a distal end with a coupling element
adapted to be detachably coupled to the implant, the implant
opening slidable over the shaft of the first tool when the implant
is coupled to the coupling element of the second tool, the second
tool proportioned such that a proximal end of the second tool
remains outside the patient during advancement of the implant over
the distal end of the first tool and into engagement with the
anchor within the body cavity.
58. The medical implant system according to claim 57, wherein the
coupling element of the second tool includes at least one
longitudinally-extending pin extendable through a portion of the
implant.
59. The medical implant system according to claim 58, wherein the
pin includes a free distal end, and wherein the coupling element
further includes a distal containment element positioned such that
relative movement of the free distal end of the pin and the distal
containment element towards one another to a first position
prevents detachment of the implant from the pin, and such that
relative movement of the free distal end of the pin away from one
another to a second position exposes the pin to allow detachment of
the implant from the pin.
60. The medical implant system according to claim 59, wherein the
coupling element of the second tool includes a plurality of
longitudinally-extendable pins extendable through the implant, and
wherein in the second position the distal containment element is
positioned to detachment of the implant from the plurality of
pins.
61. The medical implant system according to claim 60, wherein the
implant includes a base, a wall coupled to the base and surrounding
an interior, a first opening in the base, and a plurality of second
openings surrounding the exit port, and wherein the plurality of
pins are positionable within the plurality of second openings, with
a shaft of the second tool extending through the exit port.
Description
PRIORITY
[0001] This is application claims priority to U.S. Provisional
Application No. 60/950,584, filed Jul. 18, 2007, and U.S.
Provisional Application No. 61/042,862, filed Apr. 7, 2008.
TECHNICAL FIELD OF THE INVENTION
[0002] The present invention relates to the field of systems for
use in endoscopically implanting devices within the
gastrointestinal system.
BACKGROUND
[0003] An anatomical view of a human stomach S and associated
features is shown in FIG. 1. The esophagus E delivers food from the
mouth to the proximal portion of the stomach S. The z-line or
gastro-esophageal junction Z is the irregularly-shaped border
between the thin tissue of the esophagus and the thicker tissue of
the stomach wall. The gastro-esophageal junction region G is the
region encompassing the distal portion of the esophagus E, the
z-line, and the proximal portion of the stomach S.
[0004] Stomach S includes a fundus F at its proximal end and an
antrum A at its distal end. Antrum A feeds into the pylorus P which
attaches to the duodenum D, the proximal region of the small
intestine. Within the pylorus P is a sphincter that prevents
backflow of food from the duodenum D into the stomach. The middle
region of the small intestine, positioned distally of the duodenum
D, is the jejunum J.
[0005] Several prior applications, including U.S. Publication No.
US 2007/0276432 having a priority date of Oct. 8, 2004 and U.S.
Publication No. US 2008/0065122, filed May 23, 2006 describe
methods according to which medical implants are coupled to tissue
structures, such as plications or folds, formed within the stomach.
Examples of methods and devices for forming such tissue structures
are described in U.S. Publication No. US 2007/0219571 (entitled
ENDOSCOPIC PLICATION DEVICES AND METHOD), filed Oct. 3, 2006, U.S.
application Ser. No. 11/900,757 (entitled ENDOSCOPIC PLICATION
DEVICE AND METHOD), filed Sep. 13, 2007, and U.S. application Ser.
No. 12/050,169 (entitled ENDOSCOPIC STAPLING DEVICES AND METHODS),
filed Mar. 18, 2008. Each of the referenced publications and
applications is incorporated herein by reference.
[0006] As disclosed in these prior applications, more robust and
long lasting coupling between the implant and the surrounding
stomach wall tissue is achieved when the plications/folds are
formed by retaining regions of serosal tissue (i.e., the tissue on
the exterior surface of the stomach) in contact with one another.
Over time, adhesions form between the opposed serosal layers. These
adhesions help to create strong bonds that can facilitate retention
of the plication/fold over extended durations, despite the forces
imparted on them by stomach movement and implanted devices
[0007] Several of the disclosed methods for forming tissue
plications include a step in which a hole or cut is formed in the
plication, using the plication device or other devices. An example
of this type of plication is shown in FIG. 2A. This application
discloses a system for attaching a medical implant to cutouts of
this type, or to other types of openings in the plications (e.g.,
cuts, slits, perforations, tissue tunnels, etc.).
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a schematic illustration of a human stomach and a
portion of the small intestine.
[0009] FIG. 2A is a partial section of a stomach wall showing a
stomach wall plication having an opening formed in it.
[0010] FIG. 2B is a cross-section view taken along the plane
designated 2B-2B in FIG. 1, and illustrating five plications formed
in a gastro-esophageal junction region of the stomach.
[0011] FIG. 3 shows an endoscopic implant system.
[0012] FIG. 4A is a perspective view of the anchor of the implant
system of FIG. 3.
[0013] FIG. 4B is a perspective view of the anchor of FIG. 4A,
showing the head separated from the stem.
[0014] FIGS. 5-7 are partial section views of a human stomach
schematically illustrating the anchor of FIG. 4A positioned in an
opening in a stomach wall plication.
[0015] FIG. 8A is a perspective view of an anchor hand-off
tool.
[0016] FIGS. 8B and 8C are perspective views showing the anchor
coupled to the anchor hand-off tool.
[0017] FIG. 9A is a side elevation view of an anchor grasper in the
open position.
[0018] FIG. 9B shows the distal end of the anchor grasper of FIG.
9A in the closed position.
[0019] FIG. 10A is a top plan view of the anchor grasper of FIG.
9A.
[0020] FIG. 10B is a cross-section view taken along the plane
designated 10B-10B in FIG. 10A.
[0021] FIGS. 11A and 11B are side elevation views of the distal end
of an alternative anchor grasper.
[0022] FIG. 12A shows a top perspective view of a first embodiment
of a restrictor.
[0023] FIG. 12B shows a side perspective view of a second
embodiment of a restrictor.
[0024] FIG. 12C shows a top perspective view of a third embodiment
of a restrictor.
[0025] FIG. 13 shows a top perspective view of a fourth embodiment
of a restrictor.
[0026] FIG. 14A shows a side perspective view of a fifth embodiment
of a restrictor.
[0027] FIG. 14B is a perspective view of the embodiment of FIG.
14A, showing only the rib structure.
[0028] FIG. 15A is a side elevation view of a restrictor guide.
[0029] FIG. 15B is a cross-section view of the restrictor guide
taken along the plane designated 15B-15B in FIG. 15A.
[0030] FIG. 16A is a perspective view of the distal portion of the
restrictor guide, showing the mount in the open configuration.
[0031] FIG. 16B is similar to FIG. 16A and shows the mount in the
closed configuration.
[0032] FIG. 16C is a cross-section view of the mount in the open
configuration.
[0033] FIG. 17A is a perspective view of a restrictor, showing the
restrictor positioned on the restrictor guide, with the mount in
the open configuration.
[0034] FIG. 17B is similar to FIG. 17A but shows the mount in the
closed configuration.
[0035] FIG. 17C is a perspective showing the interior of a
restrictor positioned on the restrictor guide.
[0036] FIG. 18A is a perspective view showing the proximal end of
the restrictor guide.
[0037] FIG. 18B is a perspective view showing the distal portion of
the multi-lumen portion of the restrictor guide.
[0038] FIGS. 19A and 19B schematically illustrate elements of the
system positioned in the stomach in preparation for transferring an
anchor from an anchor hand-off to the anchor grasper that will then
draw the anchor through the opening in the plication.
[0039] FIGS. 20A-20F schematically illustrate transfer of the
anchor from the anchor hand-off to the anchor grasper within the
stomach.
[0040] FIGS. 21A and 21B are perspective views showing the anchor
grasper engaging different portions of the anchor head.
[0041] FIGS. 22A-22C schematically illustrate a plurality of
anchors that have been placed in plications in the stomach,
together with elements of the disclosed system.
[0042] FIG. 23 is a perspective view of the proximal end of the
endogastric tube, showing use of the tool organizer.
[0043] FIG. 24A is a perspective view of a restrictor being
advanced onto proximal ends of a collection of anchor graspers.
[0044] FIG. 24B is a perspective view similar to FIG. 24A showing
the restrictor advanced further along the anchor graspers.
[0045] FIG. 25A is a schematic illustration showing the downstream
side of a restrictor within the stomach, anchored to plications
using anchors.
[0046] FIG. 25B is a schematic illustration showing the upstream
side of a restrictor within the stomach, anchored to plications
using anchors.
[0047] FIGS. 26A-26D schematically illustrate use of the plicator
for forming tissue plications and for forming holes in the plicated
tissue.
DETAILED DESCRIPTION
[0048] FIG. 2B is a schematic cross-section view of the stomach,
looking distally into the stomach interior. In this view, five
tissue plications P having openings such as cutouts C are shown to
have been formed in the stomach wall tissue. This view would seem
to illustrate clear access via the esophagus to the plications and
cutouts using endoscopic instruments. However, the natural
undulations and folds of the actual stomach tissue, and the
constant movement of the stomach, limit the visibility of the
cutouts and even the plications themselves, rendering it difficult
to endoscopically access the cutouts in an actual human subject.
The disclosed system facilitates access to the cutouts, and
provides for an efficient method for coupling an implant to the
cutouts.
[0049] FIG. 3 illustrates an embodiment of an endoscopic implant
system 10 that may be used for this purpose. In general, system 10
includes multiple anchors 12 (one shown) that are implanted in the
cutouts and an implant 14 to be coupled to the anchors 12. The
implant can be any type of implant to be anchored within the
stomach. In the disclosed embodiment, the implant is a restrictor
14 designed to slow the rate at which food can enter the stomach
from the esophagus.
[0050] An anchor hand-off 16 delivers the anchors into the stomach,
and anchor graspers 18 (one shown) are used to position the anchors
within the tissue openings and also to guide the restrictor 14 to
the implanted anchors. A restrictor guide 20 is provided for
advancing the restrictor into position in the stomach. An
endogastric overtube 22 is provided for establishing a working
channel between the mouth and the stomach. Other tools shown
elsewhere in the drawings, such as a multi-lumen guide 24 (FIG.
19A), articulated guides 25 (FIG. 19A), and one or more endoscopes
26 (FIG. 19A) are additionally provided.
Anchor
[0051] One embodiment of an anchor 12 is shown in FIG. 4. A
preferred anchor will pass though the opening C in the plication
cutout with relative ease and minimal tissue trauma, but will
resist pulling out of the opening in the cutout when subjected to
the stresses imparted to it by the restrictor. Moreover, a
preferred anchor will minimize the stress and strain on the stomach
wall and distribute a given stress as evenly as possible so as to
prevent the stomach's natural defense from engaging in an attempt
to eliminate the anchors and restrictor.
[0052] Referring to FIG. 4A, the general features of the anchor 12
include a base 28, a stem 30, and a head 32. The anchor is formed
using materials that are durable within the stomach environment. In
one embodiment, the head 32 is molded out of a higher durometer
compliant material (such as 50 shore A durometer Silicone) while
the stem 30 and base 28 are molded out of a softer compliant
material (such as 5 shore A durometer Silicone). Since the loading
on the anchor from the restrictor implant can be seen as shear
against the edges of the opening in the plication, the stem 30 is
formed to have a relatively large diameter (2 mm-8 mm) to minimize
stress and abrasion on the stomach wall tissue inside the opening.
The edges of the anchor are molded with generous fillet radii to
minimize abrasion of stomach wall tissue.
[0053] Head 32 includes a ring 34 and a plurality of struts 36
coupling the ring 34 to the stem 30, and an elongate loop 38
extending from the ring 34. The anchor is elastically deformable to
an elongated shape (see FIGS. 20D and 20E) in response to
application of tension to the ring 34 or loop 38 (collectively
referred to as the "rim"). This allows the anchor to be drawn into
a streamlined shape so that it can be drawn through the opening in
the plication and also through an opening in the restrictor. When
the anchor is pulled from the rim, its shape lengthens and slims
down to fit through a much smaller hole. For example in one
embodiment, in its natural state the anchor has an outer head
diameter of approximately 0.600 inch (15 mm), but in its
streamlined orientation it can fit through a plication opening of
0.200 inch (5 mm). However, once implanted, the anchor's shape
resists pull-out force to a higher degree since the rim is not
being pulled and lengthened directly. Also in this embodiment, the
base is designed so it will not pull through the hole and may have
an outer diameter of approximately 1 inch (25.4 mm)
[0054] Referring to the top view of the anchor 12 shown in FIG. 5,
when an anchor is implanted in a plication opening, the anchor's
proximity to the wall of the stomach with its enveloping rugae can
make it difficult to find and grab onto the anchor when it is time
to couple the restrictor implant to the anchors. The head 32 is
shaped to have an undulating profile to enhance its visibility and
accessibility when the anchor is positioned in a plication opening.
The undulation of the head forces several of the elements of the
head away from the wall to make them more visible and also to allow
a grasping tool to latch onto one of those elements without also
grabbing adjacent tissue.
[0055] Referring to FIG. 6, the base 28 is preferably formed to
have an asymmetrical shape. In the illustrated example, one edge 40
of the base is formed to have a flatter curvature than that of the
other edge 42 of the base. When implanted, the anchor self-orients
to position the flatter edge 40 against the adjacent stomach wall
as shown. Since the loop 38 of the head extends in a direction
opposite to the side of the anchor on which the flatter edge 40 is
position, this self-alignment causes the loop 38 to extend towards
the center of the stomach as shown in FIG. 7. This makes it easier
to find segments of the anchor head amongst the folds of the
stomach which can envelope other segments.
[0056] Referring again to FIG. 6, the base 28 preferably includes a
relatively large surface area (e.g., approximately 1 square inch)
so as to distribute the stress of holding the restrictive implant
in place over a large percentage of the surface area of the tissue
plication. Reinforcing ribs 44 may be positioned on the underside
of the base, radiating from the stem to the edges of the base, to
facilitate distribution of stress while minimizing the overall
weight of the base.
Anchor Hand-Off Tool
[0057] Anchor hand-off 16 is an instrument used to deliver
individual anchors to the implantation site, and to hand-off each
anchor to an anchor grasper which pulls the anchor through an
opening in a plication.
[0058] Referring to FIG. 8A, one embodiment of an anchor hand-off
18 includes a torqueable elongate shaft 46 having a wire element 48
extending from its distal end and attachable to an anchor.
[0059] In one embodiment, the anchor hand-off 16 has a horseshoe
shaped form with an opening 45 that narrows to form a constriction
47. The stretchable nature of the anchor stem 30 allows it to be
squeezed through the constriction 47 and thus held in place by
friction. See FIGS. 8B-8D. Upon pulling on the head portion 32 by
the anchor grasper, 18, the stem 30 elongates and passes out of the
horseshoe shaped constriction.
[0060] Shaft 46 is slidably disposed in an articulating guide 49
that will articulate in response to actuation using pull wires or
other means known to those skilled in the art. The articulating
guide 26 may be one with video capability, for example it might be
an articulating endoscope. In one embodiment, wire element 48 is
detachable from the shaft 46 of the anchor hand-off 16 to allow
shaft 48 to pass through a small diameter tool channel in the
articulating guide 26. Once the distal end of the shaft 46 reaches
the distal end of the guide 26, the wire element 48 is coupled to
the shaft 46.
[0061] Furthermore, the anchor hand-off tool 16 may be designed to
hold the anchor behind (or axially off-set from) the distal tip of
the articulating guide 26 with video capability. This facilitates
greater visibility at the target site/plication by positioning the
held anchor out of the endoscope's field of view as shown in FIGS.
8C and 8D. To perform the actual hand-off of the anchor 12, the
user can extend and torque the hand-off tool 16 to position at
least a portion of the anchor head 32 within the field of view.
Anchor Grasper Tool
[0062] Anchor grasper 18 is designed to couple to or engage a
portion of the head 32 of an anchor 12. It is used to pull the
anchor 12 through an opening in a plication, and to pull the anchor
through a corresponding opening in a restrictor that is to be
implanted. The anchor grasper 18 may have a variety of designs that
allow these functions to be carried out. One such design is shown
in FIGS. 9A and 9B an employs a coupling/grasping element 50 that
takes the form of a hook 52 having a gate 54 that closes against
the opening in the hook 52. The hook and gate are naturally biased
in the open position shown in FIG. 9A.
[0063] A closure tube 56 is longitudinally slidable over the hook
and gate to lock them in the closed position, thus preventing them
from separating. The collar and associated features are
proportioned to ensure that when the grasping element 50 is to be
locked, bending of the shaft of the anchor grasper 18 does not
cause the closure tube 56 to slide into a position that will
release the grasping element 50 from the locked position.
[0064] Referring to FIG. 10B, the closure tube 56 is mounted to a
torqueable element 58 (preferably a coil), which in turn is coupled
to outer tubing 60. An L-shaped slot 62 is formed in the outer
tubing 60. As best shown in FIG. 10A, slot 62 includes a
longitudinal segment 63a and a partially circumferential segment
63b.
[0065] Hypotube 64 is slidably and rotatably disposed within outer
tubing 60, and includes a pin 66 disposed within the slot 62.
Hypotube 64 is mounted to a tapered handle 68. A cable 70 has a
distal end coupled to the grasping element 50 and a proximal end
mounted to the handle 68.
[0066] To close and lock the grasping element, the outer tube 60 is
advanced distally relative to the handle 68. Advancement of the
outer tube 60 pushes the coil 58 and thus the closure tube 56 in a
distal position until the closure tube 56 moves the grasping
element 50 to the closed position shown in FIG. 9B. As the outer
tube 60 moves distally, longitudinal segment 63a of the slot 62
slides over pin 66. The outer tube 60 is then rotated to cause
positioning of pin 66 within the circumferential segment 63b of the
slot 62, and to thereby lock the outer tube 60 in the distal
position. To unlock the grasper element 50, the outer tube 60 is
rotated in the opposite direction to release the pin 66 from the
circumferential segment 63b. Since the closure tube is no longer
locked in the distal position, the grasping element 50 moves to the
open position due to its natural bias, thereby pushing the outer
tube 60 in a proximal direction.
[0067] FIGS. 11A and 11B show an alternative grasper element 50a
which is moved between open and closed positions using a system 72
of linkages pivoted using a longitudinally slidable push rod
74.
Restrictor
[0068] The restrictor is an implant designed to slow the passage of
food from the esophagus into the stomach. The illustrated
embodiments, the restrictor is positioned in the stomach such that
food enters the restrictor through a proximal opening and exits the
restrictor through a distal opening. The restrictor and/or openings
are proportioned to slow the rate at which food can move into or
through the restrictor, and/or from the restrictor into the rest of
the stomach.
[0069] A preferred restrictor is proportioned to be coupled to
anchors that have been coupled to plications in the
gastroesophageal junction region of the proximal stomach. In a
preferred design, the restrictor 14 includes features that minimize
pulling against the anchors when the restrictor encounters stress
as a result of food moving through the restrictor and/or movement
of the stomach. Minimizing pulling at the anchors is beneficial for
minimizing stress on the stomach wall tissue coupled to the
anchors. In general, the restrictor 14 is designed to have
compliance between the anchor points (i.e., the points at which the
implant is coupled to the tissue directly or using the anchors).
This compliance may be achieved using the geometry of the
restrictor 14 and/or using restrictor materials selected to give
compliance between anchor points.
[0070] In a first embodiment shown in FIG. 12A, the restrictor 14
is a sleeve having a wall and a plurality of anchor openings 80
formed in the wall. The restrictor wall is an undulating wall
defining multiple folds 76 that give it compliance even when molded
from a relatively more stiff material (such as 30 shore A
silicone). When viewed from the side (see the second embodiment 14a
in FIG. 12B), it can be seen that the proximal edge of the
restrictor 14 undulates to define peaks 78 in the profile of the
proximal edge. When viewed from the top (FIG. 12A), it can be seen
that the circumferential profile of the restrictor also includes
peaks 82 extending radially outwardly. These peaks 82 define chutes
84 extending from the proximal peaks 78 towards a distal orifice
86. When the restrictor is implanted, the chutes 84 help to channel
ingested material towards the distal orifice 86.
[0071] Anchor openings 80 are positioned between the radial peaks
82. These openings may be positioned in the portion of the wall
that is at the most radially inward position as on the restrictor
14a of FIG. 12B, or the undulations in the wall may be such that
the openings 80 are in a section of wall that is positioned between
some inwardly extending folds 88 as in FIG. 12A (or that, in other
words, forms smaller radial peaks 90 than the radial peaks 82).
[0072] Openings 80 may be surrounded by reinforced sections 92
formed using thicker regions of silicone, or a stronger material
embedded in or attached to the silicone. Additional reinforcements
such as ribs 94a, 94b may extend from the openings 80 towards the
orifice 86 and/or from the proximal peaks 78 towards the orifice 86
and may be formed using similar techniques.
[0073] The edge of the wall defining the orifice 86 preferably
includes folds or undulations 96, allowing the orifice to be
compliant as well. In addition, small holes 98 are arranged around
the orifice to allow the restrictor 14 to be coupled to the
restrictor guide used to deliver the restrictor into the
stomach.
[0074] An alternative restrictor 14b shown in FIG. 12C is similar
to the restrictor of FIG. 12A, but is molded to be flat for ease of
manufacturing, but assumes its undulating configuration at the
folds when coupled to anchors at anchor openings 80.
[0075] Yet another alternative restrictor 14c (FIG. 13) is molded
out of highly compliant material (such as 40 shore 00 silicone) to
put minimal stress on attached stomach tissue. This embodiment
includes a reinforced proximal rim 100.
[0076] An additional restrictor 14d is molded out of a combination
of high and low compliance material (such as 50 shore A plus 40
shore 00 silicones) in different areas of the restrictor to achieve
optimal performance. A rib structure 94c (see FIG. 14B) out of
stiffer material serves to maintain the restrictor shape in the
open position within the stomach. IN this example, rib structure
94c includes an undulating ring 94d encircling the orifice 86, and
ribs 94e extending to peaks 78. In this manner, the rib structure
94c maintains apposition of the restrictor against the wall of the
stomach in order to improve the effectiveness of catching food,
particularly in the chutes 84. In addition to the stiffer rib
structure, the assembled restrictor contains a very soft web 95 of
material that forms the funnel shape and also serves to link
together the anchor points 80 (see FIG. 14A). The soft compliant
nature of the web material minimizes the stress to the plication
tissue by allowing full flexibility.
Restrictor Guide Tool
[0077] Restrictor guide 20 generally includes a tubular shaft 101,
a distal portion comprising a coupling element/mount 102 and a
proximal portion 104.
[0078] In a preferred restrictor guide, the mount 102 is designed
to support the restrictor 14 during delivery of the restrictor into
the stomach and coupling of the restrictor 12 to the stomach wall
(directly or using anchors or other means as disclosed herein). In
the illustrated embodiment, mount 102 includes a collar 103 on the
distal end of the shaft 101. A pair of tubes 112 extend distally
between the collar 103 and a ring 107. Ring 107 includes a
plurality of distally extending pins 106 and a central opening 109.
A tube 111 is positioned co-axially with the opening 109. A distal
cap 108 is mounted to the distal end of the tube 111. Cap 108
includes an opening positioned in alignment with the opening of the
ring 107 and the lumen of the tube 111. Bores 110 in the cap are
positioned so that proximal advancement of the cap 108 relative to
the ring 107 causes pins 106 to enter the bores 110.
[0079] Referring to FIG. 17A, pins 106 are arranged to allow a user
to couple the restrictor 14 to the restrictor mount by threading
the holes 98 surrounding the orifice in the restrictor 14 over the
pins 106 as shown. When the restrictor 14 is mounted in this way,
the tube 111 is disposed in the orifice 86 of the restrictor, and
the cap 108 is positioned distal to the restrictor. Restrictor 14
is retained on the mount 102 by moving the cap 108 in a proximal
direction until bores 110 slide over the pins 106, thus capturing
the restrictor 14 between the cap 108 and the ring 107 by
preventing the restrictor from sliding off the pins. See FIG.
17B.
[0080] Drive rods 112a (FIG. 16A) extend through the tubes 112 and
are coupled at their distal ends to flanges 120 on the proximal end
of tube 111. The proximal ends of the drive rods 112a are
advanceable by an actuator at the proximal end of the restrictor
guide. Manipulation of the actuator will cause the drive rods 112a
to move distally relative to the tubes 112, causing distal movement
of the cap 108 relative to the ring 107. In one current embodiment,
rotation of a threaded nut on the proximal handle moves a threaded
piece inside the handle that is connected to wires or cables that
communicate with the drive rods 112a. In another embodiment, the
drive rods 112a may be lead screws, and the actuator may include a
knob and associated gearing for rotating the lead screws such that
they advance the cap 108 distally. Alternatively, the actuator may
include a spring that is initially locked in a compressed position
using a latch. According to this embodiment, a button or other
element is manipulated by the user to disengage the latch, thus
releasing the spring from the compressed position to drive the
drive rods distally. Other alternatives include pneumatic or
hydraulic actuation of the cap 108. In other embodiments, the
actuator may be a handle that allows the user to manually advance
the drive rods to advance the cap.
[0081] Proximal portion 104 of the restrictor guide 20 is a
multi-lumen guide having a central lumen 114 through which the
tubular shaft 101 extends, and a plurality of peripheral lumens 116
arranged around the central lumen. The peripheral lumens 116 are
proportioned to accommodate the anchor graspers 18. Each of the
peripheral lumens 116 has a proximal port fitted with a seal (which
may be, for example, a duck bill seal) that will seal around the
shaft of a grasper 18 positioned in the lumen, and that will
self-seal when the grasper 18 is removed from the lumen.
Exemplary Procedure
[0082] Use of the system 10 to implant a restrictor 14 will next be
described. According to one embodiment, the method is performed
following an initial procedure in which a plurality of plications P
having cutouts or other openings C are formed. In another
embodiment, after each plication is formed, an anchor 12 is
implanted in that plication's opening for the dual purpose of
marking the location of the plication as well as ensuring that the
opening does not close in the natural healing process of the
tissue. The anchor implantation procedure may immediately precede
restrictor implantation, or may instead be performed in advance of
the restrictor implantation procedure to allow reinforcement of the
plications through the body's healing process.
[0083] In the initial phase of the restrictor implantation
procedure, anchors 12 are positioned in the openings of the
plications P. Referring to FIG. 19A, the endogastric tube 22 is
introduced into the mouth and through the esophagus, and parked
with its distal opening in a portion of the stomach or esophagus
that is proximal to the plications P. After each plication with
opening is created, a multi-lumen (or cannulation) guide tube 24
may be passed through the endogastric tube 22. Multi-lumen guide
tube 24 may have a central lumen 24a and peripheral lumen 24b in a
similar arrangement to the lumen of the restrictor guide 20 (FIG.
18B).
[0084] Outside the body, an anchor hand-off 16 is passed through a
tool channel of an endoscope 26 such that the anchor engaging wire
48 extends from the endoscope lumen. With the engaging wire in this
position, an anchor 12 is coupled to the engaging wire 48, and the
endoscope 26, anchor hand-off 16, and anchor 12 are together passed
through the central lumen 24a of the multi-lumen guide tube 24 and
into the stomach as shown in FIGS. 19A and 19B. The endoscope 26 is
retroflexed within the stomach to provide visualization of the
plication P.
[0085] Next, an articulating guide 25 is advanced through a
peripheral lumen 24b of the multi-lumen guide tube 24 and into the
stomach. An anchor grasper 18 is positioned in the lumen of the
guide 25. Under visualization using endoscope 26 (with anchor
hand-off 18 retracted so that the anchor is out of view), guide 25
is articulated to orient the grasper 18 towards the opening C in
the plication, and the grasper 18 is then advanced through the
opening as also shown in FIGS. 19A and 19B. The grasping element 50
of the grasper 18 is moved into the open position.
[0086] Referring to FIGS. 20A, 20B and 20C, anchor hand-off 16 is
advanced further from the endoscope 26 until the head 32 of the
anchor is positioned within reach of the grasping element 50.
Grasping element 50 is manipulated to engage the head 32. While it
is preferable to engage the loop 38 as shown in FIG. 21A, the
structure of the head 32 allows for engagement of other portions of
the head such as the struts 36 as shown in FIG. 21B, or the ring
surrounding the struts 36. Engagement between the anchor and the
anchor grasper is secured by moving the grasping element 50 into
the locked position. Next, the anchor hand-off is retracted into
the endoscope in order to separate it from the anchor grasper. This
action results in stretching the anchor stem and thus causing it to
release from the horseshoe shaped form. See FIG. 20D. The handle of
the anchor grasper 18 is then withdrawn to pull the head 32 of the
anchor through the opening C in the plication as in FIG. 20E. As
discussed above, application of tension to the head 32 causes the
anchor to elongate to a narrow profile that will pass readily
through the opening C in the plication. The jaws of the anchor
grasper 18 are opened to release the anchor 12. FIG. 20F.
[0087] The endoscope 26 and anchor hand-off 16 are withdrawn from
the guide tube 24 along with the multiple lumen guide and
articulating guide. After another plication is created, the process
is repeated for each anchor that is to be implanted. See FIGS.
22A-22C.
[0088] As each anchor is implanted, its corresponding anchor
grasper is preferably left coupled to the ring of the anchor,
although it may instead be withdrawn from the body. At the end of
the anchor-positioning phase of the procedure, each anchor is
positioned extending through a plication opening (FIG. 22A). If the
anchor graspers were left in place coupled to the rings of each
anchor, the handles of each separate anchor grasper 18 extend out
of the body. Organization of the anchor graspers 18 is maintained
by the multi-lumen cannula 24.
[0089] If the anchor graspers 18 are not left in place following
implantation of the individual anchors 12, the graspers 18 are
re-coupled to the anchors prior to the restrictor-positioning
phase. Specifically, each of the graspers 18 is reintroduced into
the stomach and endoscopically guided by its corresponding
articulated guide 25 into engagement with the head 32 of one of the
anchors. As discussed in the Anchors section above, orientation of
the loop 38 to extend in a direction opposite to the asymmetrical
base 28 helps to orient the loop 38 centrally within the stomach so
that the loops 38 may be more easily seen and engaged by the
graspers 18.
[0090] The restrictor-positioning phase of implantation begins with
each anchor that is to be coupled to the restrictor having a
separate anchor grasper 18 coupled to it. If the multi-lumen guide
24 is still in use at this point, with individual ones of the
graspers 18 in the peripheral lumen 24b, the guide 24 is withdrawn
from the endogastric tube 22 and removed from the handles of the
anchor graspers. The tapered proximal ends of the anchor graspers
18 allow the lumens 24b of the guide 24 to pass easily over them.
Before the multiple lumen guide is completely removed from the
endogastric tube 22, the anchor grasper tool shafts are locked into
a tool organizer 130 at the proximal end of the endogastric tube 22
as shown in FIG. 23. Organizer 130 includes slots 132 positioned to
receive the shafts of the graspers 18, leaving them arranged around
the main lumen 134 of the endogastric tube. This serves to maintain
the relative clocking of each grasper at the proximal end to a
corresponding anchor location at the distal end.
[0091] The restrictor 14 is prepared for implantation by threading
anchor openings 80 in the restrictor over the tapered proximal ends
of the anchor graspers 18, which at this point are still extending
out of the endogastric tube 22. FIG. 24A. The restrictor 14 is
mounted to the mount 102 of the restrictor guide 20 in the manner
disclosed in the Restrictor Guide section above. This step may be
performed before or after the restrictor is threaded over the
anchor graspers.
[0092] Next, the restrictor guide 20 is advanced over the tapered
proximal ends of the anchor graspers 18, which are still extending
out of the endogastric tube 22. The restrictor guide 20 is
positioned so that each of its peripheral lumens 116 advances over
a separate one of the anchor graspers 18. FIG. 24B. Continued
distal advancement of the guide 20 advances the guide 20 and
restrictor 14 through the endogastric tube 22 and into the
stomach.
[0093] In a final step, the anchors 12 are pulled through the
anchor openings 80 to couple the restrictor 14 to the anchors 12.
In this step, distally-oriented pressure is applied to the
restrictor guide 20 while the anchor graspers 18 are one-by-one
pulled proximally, causing the anchors 12 to elongate sufficiently
to pass through the openings 90. Coupling between each anchor and
its corresponding opening 80 is confirmed visually and/or by
tactile feedback reflecting the "pop" of the anchor moving through
the opening 80. Once the restrictor 14 has been coupled to the
anchors 12, the cap 108 of the restrictor guide 20 is advanced
distally to release the restrictor as described in the Restrictor
Guide section above. The anchor graspers 18 are unlocked and
separated from the anchors. The restrictor guide 20, anchor
graspers 18, guides, etc. are withdrawn from the body, leaving the
restrictor 14 and anchors 12 in place as shown in FIGS. 25A and
25B.
[0094] The system of FIG. 3 may additionally include one or more
tools for use in forming plications in the stomach wall tissue and
for forming holes in the plicated tissue. Examples of such
plicators are found in the following co-pending U.S. patent
applications: U.S. Publication No. US 2007/0219571 (entitled
ENDOSCOPIC PLICATION DEVICES AND METHOD), filed Oct. 3, 2006, U.S.
application Ser. No. 11/900,757 (entitled ENDOSCOPIC PLICATION
DEVICE AND METHOD), filed Sep. 13, 2007, and U.S. application Ser.
No. 12/050,169 (entitled ENDOSCOPIC STAPLING DEVICES AND METHODS),
filed Mar. 18, 2008.
[0095] Use of one such tool is generally illustrated in FIGS.
26A-26D and includes drawing stomach wall tissue into a vacuum
chamber of a plication head (FIG. 26A), compressing the tissue
(FIG. 26B), advancing fasteners such as staples through the
compressed tissue and forming a cut or hole in the compressed
tissue (FIG. 26C), and releasing the tissue from the plication
tool, leaving the plication with a hole or cut out through the
plicated tissue. In one staple arrangement, a pair of annular
staple patterns encircle the cut/hole. Anchors can be subsequently
positioned within the hole/cutout as disclosed above.
[0096] Although the disclosed system has been described in the
context of implanting a restrictor implants implantable in the
stomach for limiting limit intake of food by the patient, the
systems and methods may be used to implant other types of implants
for a variety of purposes. These implants include, but are not
limited to obstructive gastric implants that obstruct flow of food
into the stomach, gastric space occupiers for limiting effective
stomach volume, prosthetic valves for the treatment of
gastro-esophageal reflux disease, gastric stimulators, pH monitors
and drug eluting devices that release drugs, biologics or cells
into the stomach or elsewhere in the GI tract. Such drug eluting
devices might include those which release leptin (a hormone which
creates feelings of satiety), Ghrelin (a hormone which creates
feelings of hunger), octreotide (which reduces Ghrelin levels and
thus reduces hunger), Insulin, chemotherapeutic agents, natural
biologics (e.g., growth factor, cytokines) which aid in post
surgery trauma, ulcers, lacerations, etc. Still other implants
might be of a type which might provide a platform to which specific
cell types can adhere, grow and provide biologically-active gene
products to the GI tract, and/or a platform for radiation sources
that can provide a local source of radiation for therapeutic
purposes, or provide a platform whereby diagnostic ligands are
immobilized and used to sample the GI tract for evidence of
specific normal or pathological conditions, or provide an anchor
point for imaging the GI tract via cameras and other image
collecting devices. Additionally, the disclosed anchors and
restrictors are shown positioned and anchored near the
gastro-esophageal junction region of the proximal stomach, but may
be positioned and/or anchored elsewhere in the stomach or GI
system.
[0097] It should also be recognized that a number of variations of
the above-identified embodiments will be obvious to one of ordinary
skill in the art in view of the foregoing description. Accordingly,
the invention is not to be limited by those specific embodiments
and methods of the present invention shown and described herein.
Rather, the scope of the invention is to be defined by the
following claims and their equivalents.
[0098] Any and all patents and patent applications referred to
herein, including for purposes of priority, are incorporated herein
by reference.
* * * * *