U.S. patent application number 13/049329 was filed with the patent office on 2011-07-07 for endoscopic device delivery system.
This patent application is currently assigned to IntraPace, Inc.. Invention is credited to Mir A. Imran, Kurt Sparks, Baber Syed, Michael Wei, Ken Wong.
Application Number | 20110166582 13/049329 |
Document ID | / |
Family ID | 38834399 |
Filed Date | 2011-07-07 |
United States Patent
Application |
20110166582 |
Kind Code |
A1 |
Syed; Baber ; et
al. |
July 7, 2011 |
Endoscopic Device Delivery System
Abstract
A system and method are disclosed for an implantable gastric
stimulation system within the stomach. The stimulation system
includes an electronics anchor, electrode lead anchor, implantable
pulse generator and external programmer. The electronics anchor is
configured to attach to the stomach wall at a first location and
the electrode lead anchor configured to attach to the stomach wall
at a second location. The electrode lead anchor includes one or
more electrodes configured to contact the stomach wall and a
flexible lead portion coupled to the one or more electrodes at one
end with an the electrical connector portion at the other end. The
implantable pulse generator has electronic circuitry and is
attached to the electronics anchor; the electronic circuitry is
connected to the electrical connector of the electrode lead anchor
and can communicate with the one or more electrodes. The external
programmer is used to communicate with the electronic circuitry of
the pulse generator via a telemetry device to provide stimulation
instructions to the pulse generator.
Inventors: |
Syed; Baber; (Cupertino,
CA) ; Sparks; Kurt; (San Carlos, CA) ; Wong;
Ken; (Saratoga, CA) ; Wei; Michael; (Redwood
City, CA) ; Imran; Mir A.; (Los Altos Hills,
CA) |
Assignee: |
IntraPace, Inc.
Mountain View
CA
|
Family ID: |
38834399 |
Appl. No.: |
13/049329 |
Filed: |
March 16, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11766660 |
Jun 21, 2007 |
7920921 |
|
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13049329 |
|
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60815640 |
Jun 21, 2006 |
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Current U.S.
Class: |
606/129 ;
607/133 |
Current CPC
Class: |
A61B 2017/00278
20130101; A61N 1/37205 20130101; A61N 1/0558 20130101; A61N 1/3756
20130101; A61N 1/05 20130101; A61N 1/36007 20130101 |
Class at
Publication: |
606/129 ;
607/133 |
International
Class: |
A61B 19/00 20060101
A61B019/00; A61N 1/05 20060101 A61N001/05 |
Claims
1. A method for implanting an electrical stimulator comprising:
providing stimulator electronic circuitry and a first anchor
configured to anchor stimulator electronic circuitry to a stomach
wall wherein the first anchor comprises: an anchor portion, a
coupling portion and a guide coupling portion; anchoring the first
anchor to the stomach wall of a subject with the anchor portion;
coupling a guide to the guide coupling portion of the first anchor
wherein the guide extends out of an esophagus of the subject;
guiding the stimulator electronic circuitry with the guide portion
from out of the esophagus, into a coupled position with the
coupling portion of the first anchor.
2. The method of claim 1 further comprising the steps of: providing
a second anchor configured to anchor an electrode to a stomach wall
wherein the second anchor comprises: an anchor portion: a lead
portion; and an electrical connector portion, and wherein the
stimulator further comprises a lead connector; anchoring the second
anchor to the stomach wall of the subject with the anchor portion
wherein the electrical connector portion extends out of the
esophagus of the patient; and coupling the electrical connector
portion of the anchor to the lead connector of the stimulator
electronic circuitry.
3. The method of claim 2 further comprising the step of advancing
the stimulator electronic circuitry through the esophagus into the
stomach after coupling the electrical connector portion of the
anchor to the lead connector of the stimulator electronic
circuitry.
4. A method for implanting an electrical stimulator comprising:
providing stimulator electronic circuitry and an electrode anchor
configured to anchor an electrode to a stomach wall, wherein the
electrode anchor comprises: an anchor portion: a lead portion; and
an electrical connector portion, and wherein the stimulator further
comprises a lead connector; anchoring the electrode anchor to the
stomach wall of the subject with the anchor portion wherein the
electrical connector portion extends out of the esophagus of the
patient; and coupling the electrical connector portion of the
anchor to the lead connector of the stimulator electronic
circuitry.
5. A system for implanting an anchor on a stomach wall from within
the stomach, the system comprising: an anchor comprising an
expandable portion and an elongate portion wherein when implanted
in a stomach wall, the expandable portion is expanded to engage an
outside of a stomach wall and the elongate portion extends through
a stomach wall; a dilator configured to dilate an opening through
the stomach wall; and a delivery cannula positionable through the
opening in the stomach wall and configured to receive the anchor
advanced through the cannula into an implanted position.
6. The system of claim 5 wherein the elongate portion of the anchor
further comprises a guide coupling portion, and wherein the system
further comprises a guide configured to couple to the guide
coupling portion.
7. The system of claim 6 wherein the guide further comprises a
tension mechanism configured to provide tension with respect to the
elongate portion of the anchor when coupled thereto.
8. The system of claim 7 wherein the guide is configured to
manipulate the anchor when coupled to the guide coupling portion
and the tension mechanism.
9. A system for accessing space adjacent a serosa of a stomach
through an esophagus, the system comprising: a first balloon
catheter having an expandable first balloon configured to slide
over a guidewire extending out of the esophagus, the first balloon
being sized to span the stomach wall thickness and to inflate to a
first diameter and dilate an opening through the stomach wall; and
a sheath configured to slide over the first balloon catheter and
contact the balloon inflated to the first diameter, the first
diameter being sufficient to slide the sheath in unison with the
first balloon catheter through the dilated opening until the sheath
extends through the stomach wall into the space, the balloon being
withdrawable proximally through the sheath when deflated.
10. The system of claim 9, wherein the first balloon has a length
of greater than approximately 4 mm.
11. The system of claim 9, further comprising: a hollow needle
having a proximal end and a distal end, the proximal end configured
to extend out of the esophagus of the patient and the distal end
configured to pierce the stomach wall to create the opening into
the space; and a first guidewire configured to slide within the
hollow needle.
12. The system of claim 9, further comprising: a crossing catheter;
a second balloon catheter having a second balloon expandable from a
deflated configuration to a second diameter; the second balloon in
the deflated configuration being smaller than the dilated opening
to facilitate positioning the second balloon within the opening
when the opening has been dilated by the first balloon, the second
diameter being greater than an outer diameter of the crossing
catheter, the second balloon of the second balloon catheter
slidably advanceable through the crossing catheter when in the
deflated configuration for bringing a distal end of the crossing
catheter into contact with the inflated second balloon, the
crossing catheter and second balloon catheter advanceable in unison
from outside the esophagus through the opening until the crossing
catheter extends through the stomach wall.
13. An anchor for implantation of a stimulation system within the
stomach, the system comprising: an elongated portion having distal
end, a proximal end and one or more detents along the elongated
portion, wherein the elongate portion is configured to extend
through a hole in the stomach wall; an expandable portion coupled
to the distal end of the elongated portion, the expandable portion
being configured to collapse when inserted through the hole in the
stomach wall and expand to engage an outside of a stomach wall; and
a retaining element configured to engage one of the detents on the
elongate portion to hold the anchor in place in the stomach
wall.
14. The anchor of claim 13, wherein the anchor is an electronics
anchor, further comprising: a tapered end on the proximal end of
the elongate portion; and a loop on the tapered end, wherein the
tapered end and loop are configured to engage the distal end of a
guide element for attachment of the retaining element to the
elongate portion.
15. The anchor of claim 13, wherein the anchor is an electrode lead
anchor, further comprising: one or more electrodes with exposed
surfaces on the elongate portion and/or the expandable portion; and
a flexible lead portion with electrical connectors therethrough
having a distal end coupled to the one or more electrodes and a
proximal end coupled to a lead connector, wherein the lead
connector is configured to couple with electronic circuitry of a
stimulator.
16. A method for implanting a stimulation system within the stomach
comprising: attaching an electrode lead anchor to the stomach wall
at a first location, the electrode lead anchor having one or more
electrodes in contact with the stomach wall and an electrical
connector coupled to the electrode(s); temporarily capping the
electrical connector; allowing a healing period for the first
location in the stomach wall; after the healing period, coupling
the connector to a pulse generator having electronic circuitry;
implanting the electronic circuitry and transmitting stomach
stimulation signals from the electronic circuitry to the stomach
via the electrode(s).
17. The method of claim 16, wherein the healing period is longer
than two weeks.
18. The method of claim 16, the electrode lead anchor further
comprising a flexible lead portion with electrical connectors
therethrough coupled to the electrodes at a distal end and the
electrical connector portion at a proximal end, and a retaining
element having one or more arms; the method further comprising:
attaching an electronics anchor to the stomach wall at a first
location; attaching a temporary cap to the electrical connector
portion; attaching the temporary cap with the one or more arms of
the retaining element; after the healing period, separating the
temporary cap from the one or more arms and removing the temporary
cap; coupling the electrical connector portion of the electrode
lead anchor to the electronic circuitry in the electrical pulse
generator; and attaching the pulse generator with the electronics
anchor.
19. A stimulation system for implantation within the stomach
comprising: an electronics anchor configured to attach to the
stomach wall at a first location; an electrode lead anchor
configured to attach to the stomach wall at a second location, the
electrode lead anchor having one or more electrodes configured to
contact the stomach wall and a flexible lead portion with
electrical connectors therethrough coupled to the one or more
electrodes at a distal end and an the electrical connector portion
at a proximal end; a pulse generator coupled to the electronics
anchor, the pulse generator having electronic circuitry coupled to
the electrical connector portion of the electrode lead anchor,
wherein the electronic circuitry is configured to communicate with
the one or more electrodes; an external programmer configured to
communicate with the electronic circuitry of the pulse generator
via a telemetry device to provide stimulation instructions.
20. The system of claim 19, wherein the electronics anchor
comprises: an elongated portion having distal end, a proximal end
and one or more detents along the elongated portion, wherein the
elongate portion is configured to extend through a hole in the
stomach wall an expandable portion coupled to the distal end of the
elongated portion, the expandable portion being configured to
collapse when inserted through the hole in the stomach wall and
expand to engage an outside of a stomach wall; a retaining element
configured to engage one of the detents on the elongate portion to
hold the anchor in place in the stomach wall; a tapered end on the
proximal end of the elongate portion; and a loop on the tapered
end, wherein the tapered end and loop are configured to engage the
distal end of a guide element for attachment of the retaining
element to the elongate portion.
21. The system of claim 19, wherein the electrode lead anchor
further comprises: an elongated portion having distal end, a
proximal end and one or more detents along the elongated portion,
wherein the elongate portion is configured to extend through a hole
in the stomach wall an expandable portion coupled to the distal end
of the elongated portion, the expandable portion being configured
to collapse when inserted through the hole in the stomach wall and
expand to engage an outside of a stomach wall wherein the one or
more electrodes have exposed surfaces on the elongate portion
and/or the expandable portion; and a retaining element configured
to engage one of the detents on the elongate portion to hold the
anchor in place in the stomach wall.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a Divisional of U.S. Pat. No. 11/766,660
filed Jun. 21, 2007 (Allowed), which application claims the benefit
under 35 USC .sctn.119(e) of US Provisional Patent Application No.
60/815,640 filed Jun. 21, 2006; the full disclosures, each of which
are incorporated herein by reference in their entirety for all
purposes.
BACKGROUND OF THE INVENTION
[0002] This invention relates to medical devices, systems, and
methods. In exemplary embodiments, the invention provides an
implantable device and system and method for implanting the device
within a hollow organ. In other embodiments, the invention provides
methods and devices for providing surgical access through a stomach
or other tissue.
[0003] Electrical stimulation has been used to treat a variety of
conditions within the human body. Electrical stimulation of the
gastrointestinal tract, such as the stomach, small intestine and
colon, have been used to treat a variety of gastric conditions,
such as obesity, gastroparesis, gastric dysrhythmia, motility
related disorders and nausea, to name a few. Obesity has become one
of the leading causes of death in the United States. Electrical
stimulation has been proposed to treat obesity by causing a feeling
of satiety or reducing desire to eat.
[0004] Electrical stimulation has been proposed to treat motility
related disorders by influencing contractile behavior. Various
organs of the gastrointestinal tract such as the stomach, small
intestine and colon contain cells that are believed to govern the
organs' periodic contractile behavior. In healthy humans, in
certain regions of the organs, these cells generate and propagate
rhythmic electrical signals. In general, several types of
electrical potential activity have been observed in the
gastrointestinal tract. Consistent cyclic slow wave or pacesetter
potentials have been observed and higher frequency spike activity
has been observed that may correspond to some extent with smooth
muscle contractile activity and peristalsis. The stomach and
digestive system is also controlled by the nervous system that
includes a highly complex enteric nervous system and to some
extent, the central nervous system. It is believed that when the
pacesetter potentials are combined with a chemical or neural
excitation of the cells that smooth muscle contractile activity
occurs. It is also believed that stimulation of the stomach may
effect a subject's sensation of satiety through a complex system
involving smooth muscle stimulation or contractions, and neural and
chemical pathways.
[0005] An early attempt at a gastric stimulation device included an
electrode at the end of a nasogastric tube or catheter. The
nasogastric tube was passed into the stomach transnasally.
Electrical stimulation was applied using an external stimulator
unit through the electrode on the end of the tube. The return
electrode was placed on the abdomen. This device required a
transnasal procedure whenever stimulation was required.
[0006] Other devices used to pace the stomach have generally been
implanted by accessing the outside of the stomach through an
opening in the abdomen, either through open surgery or laparoscopic
surgery. Electrodes have been attached to the stomach
laparoscopically with attached leads extending through the abdomen
to a subcutaneously or sub-muscularly implanted electronics unit.
The devices may be anchored into the subcutaneous or sub-muscular
pocket initially by a suture anchor and/or eventually by fibrous
tissue ingrowth around the unit.
[0007] Endoscopic devices have been presented as an alternative to
open or laparoscopic surgery. And example of such devices are
described, for example in related U.S. Pat. No. 6,535,764, fully
incorporated herein by reference. U.S. Pat. No. 6,535,764 describes
a gastric stimulator that is implanted by delivering the device
through the esophagus of a subject and attaching to the stomach
wall from the inside of the stomach. Also, related U.S. patent
application Ser. No. 10/109,296, fully incorporated herein by
reference, describes a gastric stimulator that is implanted
sub-mucosally within the stomach wall.
[0008] It would be desirable to provide improved gastric
stimulation devices, delivery systems and delivery methods for an
endoscopic approach. Such devices, systems and methods should
efficiently access the implantation site through the esophagus,
should allow secure attachment of the stimulation device to the
organ wall, and should provide desired stimulation to the organ
wall. In addition, it would be desirable to provide delivery
systems and methods for passing through the organ wall, such as to
access the peritoneal cavity and/or fixedly attach devices to the
organ wall. At least some of these objectives will be met by the
present invention.
BRIEF SUMMARY OF THE INVENTION
[0009] The present invention provides an implantable gastric
stimulation device and system or method for implanting such a
device. The details of the invention are set forth below in the
detailed description, drawings and/or claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a schematic illustration showing one embodiment of
a stimulation system implanted in a stomach.
[0011] FIG. 2A is a perspective view showing one embodiment of an
electronics anchor.
[0012] FIG. 2B is a perspective view of the electronics anchor of
FIG. 2A with a guide element guiding a retaining element.
[0013] FIG. 2C is a side view of the anchoring device and retaining
element of FIG. 2B with the retaining element in place.
[0014] FIG. 2D is a side cross-sectional view of the anchoring
device and retaining element with the electronics anchor connector
attached.
[0015] FIG. 3A is a perspective view of an electrode anchor and
retaining element in accordance with one embodiment of the
invention.
[0016] FIG. 3B is a perspective view of the electrode anchor with
the retaining element in place.
[0017] FIG. 3C is a perspective view showing one embodiment of a
connector end of an electrode lead.
[0018] FIG. 3D is a perspective end view showing one embodiment of
a housing connector element configured to couple with the connector
end of electrode lead of FIG. 3C.
[0019] FIGS. 4A-4O are schematic partial cross-sectional side views
showing one embodiment of a system and method for accessing space
adjacent the serosa of the stomach through the esophagus for
delivering items through the wall of a stomach, such as the
electronics anchor shown in FIGS. 2A-2D or the electrode anchor
shown in FIGS. 3A-3D.
[0020] FIG. 4P shows one embodiment of a system 4000 for accessing
space adjacent a serosa of a stomach through an esophagus.
[0021] FIGS. 5A-5F are schematic partial cross-sectional side views
showing one embodiment of a delivery system and method for
delivering an electronics anchor shown in FIGS. 2A-2D through the
wall of a stomach.
[0022] FIGS. 6A-6C are schematic partial cross-sectional side views
showing one embodiment of a delivery system and method for
delivering an electrode anchor shown in FIGS. 3A-3D through the
wall of a stomach.
[0023] FIG. 6D is a perspective view of the electrode anchor and
retaining element with a guide element attached to the anchor used
to attach the temporary cap.
[0024] FIG. 6E is a perspective view of the electrode anchor and
retaining element with the end of the electrode lead with a
temporary capped connector attached to the retaining element.
[0025] FIG. 6F is a schematic illustration showing the electrode
lead with the temporary capped connector attached to the electrode
anchor in the stomach.
[0026] FIGS. 7A and 7B are schematic illustrations of the
stimulation system being implanted in the stomach.
[0027] FIG. 7C is an enlarged view of a portion of FIG. 7B.
[0028] FIG. 7D is schematic illustrations of the stimulation system
attached to the electrode anchor in the stomach.
DETAILED DESCRIPTION OF THE INVENTION
[0029] FIG. 1 illustrates a stimulation system 1000 in accordance
with one embodiment of the invention. In this embodiment, the
stimulation system 1000 comprises a stimulator 1100 which is
implantable within an organ, such as a stomach 100, small intestine
or colon. The stimulator 1100 comprises an implantable pulse
generator 10 and at least one stimulating electrode 3200.
[0030] The implantable pulse generator (IPG) 10 comprises
implantable electronic circuitry 1200 contained within a protective
housing 1300. The housing 1300 is constructed of a corrosion
resistant material, such as a material able to withstand
implantation within a gastric environment. The IPG 10 is attached
to the wall of the stomach 100 with the use of a housing anchor or
electronics anchor 2000. The electronics anchor 2000 is typically
attached to the wall of the stomach 100 in an area with less
contractile forces, such as the fundus area. This assists in
providing a relatively stable location for anchoring. However,
stimulation may be desired in a different area, such as near the
pes anserinus, along the lesser curvature or in desired locations
throughout the antrum or body of the stomach. Therefore, an
electrode may be positioned at any desired location with the use of
an electrode lead anchor 3000. The electrode lead anchor 3000 has a
flexible anchor portion 3050 that anchors the electrode lead anchor
3000 to the stomach wall adjacent a stimulation site. In this
embodiment, the electrode lead anchor 3000 includes a first
electrode 3200, a return electrode 3250 and flexible lead portion
3100. The flexible lead portion 3100 of the lead anchor 3000 is
coupled to the electronic circuitry 1200 through a connector 1800
within header 1400 of housing 1300. The electrode lead anchor 3000
is configured to anchor the electrode 3200 so that it is in
electrical contact with, or in proximity to the stomach wall. The
flexible lead portion 3100 electrically couples the electrodes
3200, 3250 through the header 1400 to the electronic circuitry
1200. The electronic circuitry 1200 is configured to provide an
electrically stimulating signal to the stomach wall through the
electrodes 3200, 3250. While the electrodes 3200, 3250 are shown in
particular configurations and locations on the electrode lead
anchor 3000, numerous electrode configurations and positions are
contemplated herein including, for example electrode constructs and
configurations as set forth in U.S. Pat. No. 6,535,764 and related
cases including but not limited to U.S. application Ser. Nos.
10/992,382; 11/256,264; 11/249,661; and 11/249,290, all of which
are incorporated herein by reference.
[0031] An external programmer 1500 may be used to program various
stimulation parameters or other instructions into a memory device
included with the electronic circuitry 1200. In addition, the
stimulation system 1100 may include sensors that sense one or more
parameters related to the patient's physiology and/or diet. An
example of electronic circuitry, stimulation parameters, sensors
and related systems are described for example in U.S. Pat. No.
6,535,764 and U.S. patent application Ser. No. 10/950,345; all of
which are incorporated herein by reference. The external programmer
1500 may be coupled to a telemetry device 1600 that communicates
with the electronic circuitry for the above-described and other
purposes.
[0032] Electronics Anchor
[0033] As mentioned above, the IPG 10 is anchored to the wall of
the stomach 100 with the use of an electronics anchor 2000. FIGS.
2A -2D illustrate one embodiment of an electronics anchor 2000 in
accordance with one aspect of the invention. The anchor 2000
illustrated in FIG. 2A comprises a flexible disc or distal anchor
portion 2050 coupled to an elongate portion 2100. The anchor
portion 2050 is configured to engage or oppose the serosal surface
or outside of a stomach wall. The elongate portion 2100 is
configured to extend through the stomach wall. The elongate portion
2100 includes a proximal portion 2150. The proximal portion 2150
typically resides within the stomach cavity and has a variety of
features that are accessible from within the stomach. For instance,
the proximal portion 2150 includes a plurality of detents, such as
a first detent 2200. The first detent 2200 is used to receive a
retaining element 2300, illustrated in FIG. 2B, and to hold the
retaining element 2300 in place in relation to the anchor 2000.
Thus, the retaining element 2300 has a detent mechanism 2350 which
mates with the first detent 2200.
[0034] The retaining element 2300 resides near or against the
mucosal layer or inside surface of the wall of the stomach 100 so
that the wall is held between the distal anchor portion 2050 and
the retaining element 2300.
[0035] FIG. 2C illustrates the retaining element 2300 locked into
position on the elongate portion 2100 of the electronics anchor
2000. The retaining element 2300 includes a detent mechanism 2350
for engaging detent 2200. The retaining element 2300 is typically
constructed of an elastomeric polymer material, such as a
fluoroelastomer (e.g., Viton.RTM., or Kalrez.RTM.), a
fluorosilicone or a silicone. The detent mechanism 2350 of the
retaining element 2300 may also be constructed of such a material.
The detent mechanism 2350 lockingly engages the detent 2200 so that
the retaining element 2300 is at a distance d2 from the distal
anchor portion 2050.
[0036] A distance d1 may be defined as a distance between the
retaining element 2300 and the stomach wall (not shown) which is
left after implantation and before healing occurs. The distance d2
is the distance from the inner surface of the anchor disc to the
edge of the retaining element 2300. The distance d1 permits space
for the increase of wall thickness of the stomach wall due to
healing response of the stomach after the electronics anchor 2000
is implanted (see FIG. 5F). In other embodiments, there may not be
a gap or distance d1 between the retaining element 2300 and stomach
wall which allows some tissue compression between the retaining
element 2300 and the distal anchor portion 2050. While not limited
to these dimensions, a typical de novo stomach wall thickness in
the region of the electronics anchor 2000 implantation may be from
about 2 to 5 min and after the stomach wall has healed around the
anchor, the stomach wall thickness may typically range from about 5
to 15 mm. In the antrum portion of the stomach the de novo stomach
wall thickness may range from 5 mm to 15 mm, and thickness after
healing may typically range from 10 to 25 mm, but these dimensions
are not so limited
[0037] Referring back to FIG. 2B, one embodiment of installing the
retaining element 2300 on the electronics anchor 2000 is
illustrated. The electronics anchor 2000 further comprises a
tapered end 2400 located on the proximal portion 2150 and a loop
2450 extending proximally out of the tapered end 2400. The loop
2450 may comprise a cable or other flexible tensile member, both
ends of which are embedded into a generally cylindrically-shaped
hub 2455 that may be welded into an opening at the terminal end of
the proximal portion 2150 (see FIG. 2D). Embedding of the ends of
the loop 2450 into the hub 2455 may be performed by swagging,
welding or gluing, for example. In this embodiment, the hub and
cable construction are welded into the proximal portion 2150 and
the proximal portion subsequently insert molded into a polymer
construct to form the electronics anchor 2000. The distal portion
2050 of the electronics anchor comprises a hub with a polymer disc
insert molded over the hub. The distal anchor portion 2050 and the
elongate portion 2100 of the electronics anchor 2000 between the
distal anchor portion 2050 and the first detent 2200, are typically
constructed of a corrosion resistant polymer such as a
fluoroelastomer, e.g., Viton.RTM. or Kalrez.RTM., both manufactured
by Dupont Dow. This provides flexibility to the portion of the
anchor that is positioned through the stomach wall and the
interface between the distal anchor portion 2050 and the elongate
portion 2100. In some embodiments, the more proximal portion 2150
including at least the first detent 2200 comprises a corrosion
resistant metal such as, an alloy of Nickel, titanium and Cobalt,
e.g., MP35N or MP35NLT manufactured by Fort Wayne Metals. This
provides structure for connecting the retaining element 2300 and
the connector element 1700 as described in more detail below.
However, it may be understood that the electronics anchor 2000 may
be comprised of a single material or a combination in any
arrangement so as to achieve the desired results.
[0038] Referring again to FIG. 2B, the retaining element 2300 is
installed on the electronics anchor 2000 with the use of a guide
element 2500. Once the electronics anchor 2000 has been attached to
the stomach wall (as will be described in detail in a later
section), the guide element 2500 is attached to the elongate
portion 2100 of the anchor 2000 from within the stomach cavity. The
guide element 2500 is used to guide the retaining element 2300 to
the anchor 2000. The guide element 2500 has a hook 2750 within its
distal end 2550 which is extendable and couplable to the loop 2450
at tapered end 2400 of the electronics anchor 2000. The guide
element 2500 includes an internal tapered wall 2600 defining an
opening in its distal end 2550 for receiving the tapered end 2400
and loop 2450 of the proximal portion 2150 of the electronics
anchor 2000. The guide element 2500 further includes a lumen 2650
extending axially therethrough and a tension element 2700 extending
through lumen 2650 and having the hook 2750 at its distal end for
hooking to loop 2450. The tapered wall 2600 matingly receives the
tapered end 2400 of the electronics anchor 2000 and upon applying
tension to the tension element 2700, the anchor 2000 is held firmly
to the guide element 2500 and together they may act as a single
element. Thus, the tension element 2700 may be manipulated from the
proximal end of the guide element 2500 extending out of a subject's
mouth, to hook and unhook the hook 2750 from the loop 2450 and/or
to provide compression between the electronics anchor 2000 and the
guide element 2500. The retaining element 2300 is configured to
slide over the guide element 2500 and onto the electronics anchor
2000 such that the detent mechanism 2350 of the retaining element
2300 snaps into place onto the detent 2200. With the installment of
the retaining element 2300, the stomach wall shall be positioned
between the distal anchor portion 2050 and the retaining element
2300 so as to maintain contact between the distal anchor portion
2050 and the serosal surface of the stomach wall.
[0039] FIG. 2D is a cross-sectional view showing the electronics
anchor 2000 with the retaining element 2300 attached and the
electronics anchor connector 1700 attached in a manner as described
in more detail herein. Also shown in FIG. 2D is another embodiment
of the retaining element 2300 having a dissolvable surface 2301
proximate the stomach wall 100. The dissolvable surface 2301 allows
the retaining element 2300 to apply some tissue compression between
the retaining element 2300 and the distal anchor portion 2050
during installation to seal the transgastric hole in the stomach
wall. The dissolvable surfaces may be comprised of any material
that will slowly dissolve in the gastric stomach environment, for
example, the dissolvable surface may be silicone. Another
embodiment of the elongate portion 2100 is also shown having a
dissolvable surface 2101 so that the overall diameter is larger
than the transgastric hole produced to deliver the distal anchor
portion 3050 for deployment on the serosal surface of the stomach.
The dissolvable surface 2101 thus assists in sealing the hole in
the stomach wall. In another embodiment, the entire retaining
element 2300 may be dissolvable. Once the fibrotic response forms a
fibrotic capsule around the disc or distal anchor portion 2050 on
the serosal surface or outside of a stomach wall, the retaining
element 2300 may not be needed.
[0040] Electrode Lead Anchor
[0041] As mentioned previously, the at least one stimulating
electrode 3200 electrically contacts the wall of the stomach 100
with the use of the electrode lead anchor 3000. FIGS. 3A-3B
illustrate one embodiment of an electrode lead anchor 3000 having
an anchor portion 3050; an elongate portion 3150; electrodes 3200,
3250; and a flexible lead portion 3100. The flexible lead portion
3100 connects the electrodes 3200, 3250 to the IPG 10 (not shown).
A retaining element 3600 is positionable over the flexible lead
portion 3100 portion (FIG. 3A) and the retaining element 3600 may
be secured to the elongate portion 3150 within a detent in a manner
similar to that described with respect to FIGS. 2A-2C above. Thus,
the retaining element 3600 functions similarly to the retaining
element 3200 of the electronics anchor 2000 by holding the wall of
the stomach 100 between the retaining element 3600 and the anchor
portion 3050. However, the retaining element 3600 of the electrode
lead anchor 3000 has additional features that are used during the
delivery and implantation steps of the present invention. For
example, after the electrode lead anchor 3000 is attached to the
stomach wall, the electrode lead anchor 3000 is left in place to
allow tissue ingrowth and healing. Such healing stabilizes and
strengthens the anchoring of the electrode lead anchor 3000 to the
stomach wall. While such healing is occurring, the flexible lead
portion 3100 is not attached to the IPG 10. To avoid possible
entanglement of a free floating flexible lead portion 3100 within
the stomach cavity, the flexible lead portion 3100 is attached to
the retaining element 3600 during the healing process. The
retaining element 3600 includes one or more arms 3700 with loop
hooks 3750 for attaching the flexible lead portion 3100 thereto.
Such attachment will be described and illustrated in a later
section.
[0042] Referring now to FIG. 3C, the proximal end of the flexible
lead portion 3100 is shown. The flexible lead portion 3100 is
eventually joined with the IPG 10, as illustrated in FIG. 1. To
make such a connection, the flexible lead portion 3100 has a
connector end 3425 with a lead connector 3400, as illustrated in
FIG. 3C. The lead connector 3400 is positioned on the connector end
3425 of the lead portion 3100 opposing the anchor portion 3050 on
the other end. In one embodiment, the connector 3400 comprises
female connectors 3450 and a plurality of sealing rings 3500 (FIG.
3C). The connector 3400 is designed to couple with the housing
connector 1800 of the IPG 10. FIG. 3D shows one embodiment of the
housing connector 1800 that includes a receiving portion 1850
configured for receiving the connector 3400 and engaging sealing
rings 3500 within the bore of the receiving portion 1850. Male
connectors 1875 within the housing connector 1800 electrically
couple to the female connectors 3450 of the connector 3400. Once
engaged, the electronic circuitry 1200 is electrically coupled to
the electrodes 3200, 3250. Set screws 1880 within connector 1800
may be used to secure the housing connector 1800 to the lead
connector 3400. In other embodiments, the connector 3400 and
housing connector 1800 are IS-1 connectors commonly used in cardiac
pacemaker designs.
[0043] Referring to FIGS. 4A-4P, 5A-5E and 6A-6F, systems and
methods of producing a transgastric passageway through the stomach
wall, accessing virtual space beyond the stomach wall (such as the
peritoneal cavity), and implanting the electronics anchor 2000 and
the electrode lead anchor 3000 are illustrated.
[0044] Accessing Space Adjacent the Serosa of the Stomach Through
the Esophagus
[0045] FIGS. 4A and 4B illustrate the distal end 4105 of a needle
4100 used to pierce a stomach wall 100 from within the stomach to
position a distal end 4155 of a guidewire 4150 through the stomach
wall and form an opening 200. The proximal ends (not shown) of the
needle 4100 and guidewire 4150 are positioned outside of a patient,
typically, through the esophagus of the patient. Endoscopic
visualization may be used to identify an anchor implantation site
150 in the stomach 100. Additionally or alternatively, fluoroscopic
imaging may be used when piercing the stomach wall and/or
positioning the guidewire as described herein. Once the stomach
wall 100 is pierced with the needle 4100, the guidewire 4150 is
positioned through the stomach wall 100 and preferably into a space
adjacent the serosa of the stomach, e.g. the peritoneal cavity.
[0046] As shown in FIG. 4C, the needle 4100 is then removed leaving
the guidewire 4150 in place through the stomach wall.
[0047] As shown in FIG. 4D, a balloon catheter 4250 comprising an
expandable distal end or balloon 4300 and enclosed by sheath 4200
having a distal end 4205, is guided on the guidewire 4150 to the
implantation site 150. As shown in FIG. 4E, the balloon 4300 is
advanced through the sheath 4200 so that it is positioned in the
stomach wall 100. The length of the balloon 4300 is sized so that
it is longer than the stomach wall thickness. For example, in a
typical stomach wall thickness of about 4 mm, the balloon 4300 may
have a length of greater than approximately 4 mm. Thus, when the
balloon 4300, is properly positioned, a portion of the balloon 4300
extends distally out of the stomach wall and a portion extends
proximally into the stomach. The balloon may include visual or
radiopaque markers that enable visualization of the balloon
positioning. While balloons are disclosed herein for dilating the
opening formed in the stomach, other expandable members may be used
to dilate an opening through the stomach wall at the attachment
site.
[0048] As illustrated in FIG. 4F, the balloon 4300 is inflated to
dilate the opening 200 formed through the stomach wall 100 at the
implantation site 150. The inflated outer diameter d3 of the
balloon 4300 is greater than the outer diameter d4 of the sheath
4200. The balloon 4300 dilates the opening to a size in a range
from about 2 mm to about 5 mm, but is not so limited. An initial
period of inflation of the balloon 4300 at a first pressure will
expand the hole in the stomach wall. As an example of duration and
pressure, a first pressure e.g., of a pressure greater than 5
atmospheres for 45 seconds or longer may be sufficient to expand
the hole in the stomach wall. In the next step, the distal end 4205
of the sheath 4200 will be engaged against the proximal end of the
balloon, and both balloon and sheath are advanced in unison through
the hole in the stomach. To facilitate this process, the balloon
pressure may be slightly decreased while still maintaining the
outer diameter d3 of the balloon 4300 greater than the outer
diameter d4 of the sheath 4200. During this process, the balloon
4300 will become translatable through the hole in the stomach. FIG.
4G shows both balloon 4400 and sheath 4200 having crossed through
the transgastric pathway 200 and the sheath distal end 4205 is
approximately about 0.75 inches through the stomach wall, but this
distance is not so limited. The distance the sheath is advanced may
be determined with radiopaque markers 4225 (or visible markers if
an endoscope is used for placement) positioned at a desired
distance along the sheath 4200.
[0049] Once in position, as illustrated in FIG. 4H, the balloon
4300 is deflated and the balloon catheter 4250 is withdrawn from
the sheath 4200. The sheath 4200 now provides a delivery conduit
between the esophagus and the space adjacent the serosa of the
stomach or peritoneal cavity. If a larger delivery conduit is
required, a crossing catheter may be exchanged for the sheath as
discussed below.
[0050] As illustrated in FIG. 41, a larger diameter guidewire 4350
having a distal end 4355 is inserted through the sheath 4200 and
through opening 200 in stomach 100. The sheath 4200 is then removed
(FIG. 4J). The larger diameter guidewire 4350 supports and guides a
larger diameter balloon 4400 on balloon catheter 4425, along with a
crossing catheter 4450 with a distal end 4455 larger in diameter
than the sheath 4200, into position adjacent the dilated opening
200 (FIG. 4K). During the next process, the crossing catheter 4450
will be advanced through the hole in the stomach 200, serving as a
delivery conduit for the electronics anchor 2000 and the electrode
anchor 3000. The balloon 4400 is positioned in the stomach opening
200 in a similar manner as balloon 4300 was (FIG. 4L). The balloon
4400 is then inflated to further dilate the opening 200 (FIG. 4M).
The duration and pressure of this inflation may be similar to that
used for the first balloon 4300. The diameter d5 of the inflated
balloon 4400 is slightly larger than the outer diameter d6 of the
crossing catheter 4450. The balloon 4400 dilates the opening to a
size in a range from about 4 mm to about 10 mm, but is not so
limited. After the initial inflation duration and pressure, the
balloon pressure may be decreased to allow translation of the
balloon through the hole 200 in the stomach wall, as was performed
for the initial balloon. The inflated balloon 4400 and the crossing
catheter 4450 are advanced in unison through opening 200 (FIG. 4N).
The balloon 4400 is then deflated and removed from the crossing
catheter 4450 and the distal end 4455 of the crossing catheter is
left in place through the hole 200 (FIG. 4O). The crossing catheter
4450 is sized to accommodate passing of items to the peritoneal
cavity, such as the electronics anchor 2000 and electrode anchor
3000 discussed below. In one embodiment, the inner diameter of the
crossing catheter 4450 is more than about 5 mm.
[0051] FIG. 4P shows one embodiment of a system 4000 for accessing
space adjacent a serosa of a stomach through an esophagus. The
system 4000 includes a needle 4150, a first guidewire 4100, a first
balloon catheter 4250, a sheath 4200, a second guidewire 4350, a
second balloon catheter 4425 and a crossing catheter 4450. The
needle 4150 has a proximal end 4152 and a distal end 4155, the
distal end is designed for piercing. The first guidewire 4100 has a
proximal end 4102 and a distal end 4105, and is sized to slide
through a lumen of the needle 4150. The first balloon catheter 4250
has a proximal end 4252 and an expandable first balloon 4300 on a
distal end 4255. The first balloon catheter 4250 includes an inner
lumen sized to slide over the first guidewire 4150. The sheath 4200
is designed to slide over the first balloon catheter 4250, with an
outer diameter less than the expanded diameter of the first balloon
4300. The second guidewire 4350 has a proximal end 4352 and a
distal end 4355. The second balloon catheter 4425 has a proximal
end 4427 and an expandable second balloon 4400 on a distal end
4430. The second balloon catheter 4425 includes an inner lumen
sized to slide over the second guidewire 4350. The crossing
catheter 4450 has a proximal end 4452 and a distal end 4455. The
crossing catheter 4450 includes an inner lumen sized to be delivery
conduit through the esophagus of the patient to the space adjacent
the serosa of the stomach or the peritoneal cavity.
[0052] Placement of the Electronics Anchor
[0053] FIGS. 5A-5F illustrate an embodiment of methods and delivery
devices for the placement of the electronics anchor 2000. The
anchor 2000 is positioned into the crossing catheter 4450 with the
distal anchor portion 2050 in a folded or compressed position. The
anchor 2000 is pushed through the crossing catheter 4450 with a
distal end 2505 of a guide element 2500 which is coupled to the
proximal tapered end 2400 of the anchor 2000 (FIG. 5A). The distal
anchor portion 2050 of the anchor 2000 is advanced through the
crossing catheter 4450 until the distal anchor portion 2050 extends
out of the distal end of the crossing catheter 4450 where it
unfolds or expands (FIG. 5B). The crossing catheter 4450 is then
withdrawn and the anchor portion 2050 of the anchor 2000 may be
pulled into engagement with the outer wall of the stomach, using
the guide element 2500 (FIG. 5C). A retaining element 2300 is
positioned over the guide element 2500 outside of the subject's
mouth and is advanced over the guide element 2500 using a distal
end 4505 of a coaxial push element or push element 4500 until the
detent mechanism 2350 (FIG. 2B) engages the first detent 2200 of
the anchor 2000 (FIG. 5D).
[0054] The push element 4500 and guide element 2500 are then
removed and the anchor remains in the opening (FIG. 5E). A purse
string stitched suture may also be used to cinch up the hole in the
stomach wall around the anchor. In some cases, the anchor 2000 may
be left in position for a period of time (e.g. two to four weeks,
or more than two weeks) until the stomach has healed (FIG. 5F). The
guide element 2500 is then reinserted and attached to the proximal
end 2150 of the anchor 2000 for delivery and attachment of the IPG
10 to the electronics anchor 2000, described in more detail with
respect to FIG. 7A.
[0055] Placement of the Electrode Lead Anchor
[0056] The placement of the electrode lead anchor 3000 may be
deployed in a similar manner as the electronics anchor 2000
described above. In deploying the electrode lead anchor 3000, as
illustrated in FIGS. 6A-6C, a dilated opening 210 at a second
location 160 is first formed in the stomach wall 100 for deployment
in a manner similar as that described with respect to FIGS. 4A-4O
herein. Deployment site for the electronics anchor 2000 may for
example be at a location on the fundus, and for example, for the
electrode anchor 3000 the body or antrum.
[0057] As illustrated in FIG. 6A the electrode lead anchor 3000
including the lead portion 3100 is positioned in a crossing
catheter 4450. A distal end 5105 of a push element 5100 is
positioned over the lead 3100 and is used to advance the anchor
3000 through the crossing catheter 4450 and out the distal end
4455.
[0058] As illustrated in FIG. 6B, the anchor portion 3050 is
positioned outside the stomach wall. The elongate portion extends
through the stomach wall with at least one of electrodes 3200, 3250
in electrical contact with the stomach wall. The retaining element
3600 is positioned over the flexible lead portion 3100 and is
retained on the elongate member with a detent mechanism similar to
the detent mechanism 2350 described above with respect to anchor
2000. In some embodiments, the retaining element 3600 is spaced
away from the inside of the stomach wall to permit the healing
process to occur (FIG. 6C).
[0059] As mentioned previously, the flexible lead portion 3100 is
coupled with the retaining element 3600 during the healing process.
FIGS. 6E and 6F illustrate attachment of the proximal end of the
flexible lead portion 3100 to the retaining element 3600. FIG. 6E
illustrates a temporary cap 3900 attached to the connector end 3425
of the lead portion 3100. In one embodiment, the electrode lead
anchor 3000 is implanted and left in place a few weeks before the
IPG 10 is delivered to the stomach and attached to the flexible
lead portion 3100. In this case, the temporary cap 3900 may be
secured over the proximal lead connector 3400, to seal the
connectors 3450 during the healing process. To ensure that the
flexible lead portion 3100 is not unsecured and free floating in
the stomach, the temporary cap 3900 will be attached to the
retaining element 3600 while the anchor heals in place for a
several week period, as illustrated in FIG. 6F. This attachment
forms the lead portion 3100 into a closed loop and prevents the
lead from being tied into a knot during the daily stomach
contractions associated with digestion.
[0060] Referring back to FIG. 6D, a delivery tool 3800 is shown
attached to a loop hook 3750 of retaining element 3600. The
delivery tool 3800 includes a hook (not shown) which is advancable
from its distal end to engage the loop hook 3750. The hook (not
shown) is then retracted into the delivery tool 3800 so that the
delivery tool 3800 is snug against the retaining element 3600. The
delivery tool 3800 is then used to deliver the proximal end of the
flexible lead portion 3100 to the retaining element 3600.
[0061] FIG. 6E shows the temporary cap 3900 having a flat extender
portion 3925 and a connector ring 3950. The connector ring 3950 is
configured to couple with arms 3700. To connect the temporary cap
3900 to the arms 3700 of the retaining element 3600, the proximal
end of the delivery tool 3800 is inserted through the connector
ring 3950 and advanced along the delivery tool 3800 toward the
retaining element 3600. Thus, the delivery tool 3800 is used to
guide the connector ring 3950 of the temporary cap 3900 onto the
arm 3700 of the retaining element 3600 to secure the connector end
3425 (within cap 3900) of the lead to the retaining element 3600,
thus effectively forming a closed loop of the lead portion 3100, as
illustrated in FIG. 6F. The ring 3950 is relatively flexible and
can be pushed over the conically tapered portion 3725 of the arm
3700 into a detent in the arm 3700 so that the ring 3750 is secured
onto the arm 3700.
[0062] After the healing process has occurred, the flat extender
portion 3925 of the cap 3900 is cut, freeing the proximal end of
the lead 3425 of the flexible lead portion 3100 with the temporary
cap 3900 still attached. Using endoscopic methods, the connector
end 3425 of the flexible lead portion 3100 may then be pulled
through the esophagus out of the mouth where the temporary cap 3900
is removed and the connector end 3425 is coupled to the connector
1800 of the header 1400 of the housing 1300 as shown in FIGS.
7A.
[0063] Placement of the Stimulator within the Stomach
[0064] FIGS. 7A-7D schematically illustrate the IPG 10 being
positioned into the stomach after the electronics anchor 2000 and
electrode lead anchor 3000 have been installed (see FIG. 2A through
FIG. 6F herein). A guide element 2500 having a proximal end 2502
and a distal end 2505 is used to guide the IPG 10 into a position
where it is attached to the electronics anchor 2000. A connector
element 1700 attached to the IPG 10 is positioned over the proximal
end 2502 of guide element 2500 when the IPG 10 is outside the
subject's mouth 110. At the same time, the connector 3400 of
flexible lead portion 3100 is attached to the connector 1800 within
header 1400 of IPG 10 while outside of the mouth (FIG. 7A, see also
FIGS. 1, 3C and 3D). As illustrated in FIGS. 7B-7C the connector
element 1700 is pushed with a distal end 1905 of a push element
1900, such as coaxial coil, over the guide element 2500, thereby
also pushing the housing 1300 and flexible lead portion 3300 into
the stomach. The guide element 2500 acts as a guide rail with a
compression element to guide the connector element 1700 to the
proximal end of the electronics anchor 2000, where the connector
element 1700 couples to a detent 2250 (see FIG. 2D). The connector
may be constructed of a metal material having an opening having an
inner diameter with an o-ring positioned around the inner diameter.
The o-ring 1750 engages the detent 2250 to secure the connector
element 1700 to the electronics anchor 2000 as described herein.
The o-ring 1750 or detent 2250 may be constructed of a corrosion
resistant polymer such as a fluoroelastomer, e.g., Viton.RTM. or
Kalrez.RTM.. The IPG 10 is thus implanted within the stomach,
anchored to the stomach wall by the electronics anchor 2000 and
able to stimulate the stomach wall by use of the electrode lead
anchor 3000.
[0065] It is understood that the examples and embodiments described
herein are for illustrative purposes only and that various
modifications or changes in light thereof will be suggested to
persons skilled in the art and are to be included within the spirit
and purview of this application and scope of the appended claims.
All publications, patents, and patent applications cited herein are
hereby incorporated by reference in their entirety for all
purposes.
* * * * *