U.S. patent application number 12/699792 was filed with the patent office on 2010-11-11 for radially expandable gastrointestinal stimulation device.
This patent application is currently assigned to IntraPace, Inc.. Invention is credited to Mir A. Imran.
Application Number | 20100286745 12/699792 |
Document ID | / |
Family ID | 34521925 |
Filed Date | 2010-11-11 |
United States Patent
Application |
20100286745 |
Kind Code |
A1 |
Imran; Mir A. |
November 11, 2010 |
Radially Expandable Gastrointestinal Stimulation Device
Abstract
A fixation device for holding stimulating electrodes in
electrical contact with the wall of a portion of the
gastrointestinal tract is provided. In one embodiment, the fixation
device includes an expandable member that fixes the electrodes in
electrical contact with the gastrointestinal tract wall. Also
provided is an implantable device and method for controlling the
opening and/or closing of the pylorus. In particular a device and
method is provided for stimulating the duodenum to control the
closing/and or opening of the pylorus. Finally, a method is
provided for treating obesity by controlling the pylorus to retain
food in the stomach for a desired period of time, among other
things to provide a feeling of-satiety and/or to reduce hunger. One
aspect includes controlling the pylorus's contraction by electrical
stimulation of the duodenum.
Inventors: |
Imran; Mir A.; (Los Altos
Hills, CA) |
Correspondence
Address: |
IntraPace & Townsend & Townsend & Crew LLP
Two Embarcadero Center, Eighth Floor
San Francisco
CA
94111-3834
US
|
Assignee: |
IntraPace, Inc.
Mountain View
CA
|
Family ID: |
34521925 |
Appl. No.: |
12/699792 |
Filed: |
February 3, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11281228 |
Nov 16, 2005 |
7676270 |
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|
12699792 |
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|
10691735 |
Oct 22, 2003 |
7054690 |
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11281228 |
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Current U.S.
Class: |
607/40 ;
607/133 |
Current CPC
Class: |
A61N 1/36007
20130101 |
Class at
Publication: |
607/40 ;
607/133 |
International
Class: |
A61N 1/36 20060101
A61N001/36; A61N 1/05 20060101 A61N001/05 |
Claims
1. A gastrointestinal stimulation device comprising: a fixation
device comprising a radially expandable member; an outer portion;
and at least one electrode coupled to the outer portion of the
fixation device, wherein the radially expandable member is
configured to fix the fixation device within a portion of the
gastrointestinal tract so that the at least one electrode is in
electrical contact with the gastrointestinal tract.
2. The gastrointestinal stimulation device of claim 1 comprising at
least one sensor coupled to the fixation device.
3. The gastrointestinal stimulation device of claim 2 wherein the
at least one sensor comprises at least one of a pressure sensor, an
accelerometer, a pH sensor, an impedance sensor, a temperature
sensor, or an electrical sensor.
4. The gastrointestinal stimulation device of claim 3 wherein the
pressure sensor comprises a strain gage.
5. The gastrointestinal stimulation device of claim 4 wherein the
pressure sensor measures contractions and distention in the
gastrointestinal tract.
6. The gastrointestinal stimulation device of claim 4 wherein the
pressure sensor measures contractions and distention in a
duodenum.
7. The gastrointestinal stimulation device of claim 4 wherein the
pressure sensor measures contractions and distention in an
antrum.
8. The gastrointestinal stimulation device of claim 4 wherein the
pressure sensor detects a human body's satiety.
9. The gastrointestinal stimulation device of claim 3 wherein the
accelerometer measures a function in gastrointestinal tract.
10. The gastrointestinal stimulation device of claim 3 wherein the
pH sensor detects the pH of chemicals secreted in a duodenum are
secreted in the duodenum during at least one of an onset of hunger
or an onset of eating.
11. The gastrointestinal stimulation device of claim 9 wherein the
impedance sensor comprises an impedance spectrometer.
12. The gastrointestinal stimulation device of claim 11 wherein the
impedance spectrometer measures chemical constituents of an
ingested material.
13. The gastrointestinal stimulation device of claim 3 wherein the
temperature sensor measures temperature changes in the
gastrointestinal tract, such that such that a temperature signal
from the sensor is indicative of ingested liquid material within
the gastrointestinal tract.
14. The gastrointestinal stimulation device of claim 3 wherein the
electrical sensor comprises at least one of an electromyogram (EMG)
sensor or electrogastrogram (EGG) sensor.
15. A gastrointestinal stimulation device comprising: a fixation
device comprising: a radially expandable member; an outer portion;
and at least one electrode coupled to the outer portion of the
fixation device, wherein the radially expandable member is
configured to fix the fixation device within a portion of the
gastrointestinal tract so that the at least one electrode is in
electrical contact with the gastrointestinal tract; at least one
sensor coupled to the fixation device, the at least one sensor
comprising a pressure sensor, wherein the pressure sensor comprises
a strain gage.
16. A method for treating a gastrointestinal tract of a patient,
the method comprising: affixing an fixation device within a lumen
of the gastrointestinal tract by introducing the fixation device
within the lumen, radially expanding a member of the fixation
device so that an outer portion of the fixation device engages the
surrounding gastrointestinal tract; and sensing a pressure of the
gastrointestinal tract with at least one sensor coupled to the
fixation device, by measuring a strain of the fixation device with
a strain gage.
17. The method of claim 16, wherein at least one electrode of the
fixation device is coupled to the outer portion of the fixation
device so that the at least one electrode is in electrical contact
with the gastrointestinal tract when the fixation device is
expanded therein, and further comprising stimulating the
gastrointestinal tract with the electrode.
Description
CROSS REFERENCE TO RELATED APPLICATION DATA
[0001] The present application is a Continuation of U.S.
application Ser. No. 11/281,228 filed Nov. 16, 2005 (Allowed),
which application is a Divisional of U.S. application Ser. No.
10/691,735 filed Oct. 22, 2003 (now U.S. Pat. No. 7,054,690); the
full disclosures of which are incorporated herein by reference in
their entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates to a stimulation device and method for
stimulating a portion of the gastrointestinal tract and in one
particular embodiment to a device and method for stimulating the
duodenum to control the pylorus and/or to treat obesity.
[0004] 2. Background of the Invention
[0005] In general when food is ingested into the stomach,
initially, the elastic upper portion or fundus accommodates the
food and the fundus expands. As food enters and the fundus expands
there is a pressure gradient created in the stomach between the
fundus and the antrum (fundus pylori). A number of things occur at
this time. Fluids tend to be pushed through the pylorus, which acts
as a leaky valve. Peristaltic contractions move down the stomach
from the fundus into the antrum to mix and break down food and
propel small particles through the pylorus into the duodenum. In
healthy human stomachs, peristalsis is believed to be controlled at
least in part by a region of the stomach identified near the
interface of the fundus and the corpus along the greater curvature.
In this region, there are cells believed to govern the organs'
periodic contractile behavior that generate and propagate rhythmic
electrical signals that correspond to the contractile behavior of
the stomach. These characteristic contractions are believed to
create, a pressure gradient between the fundus pylori (or antrum)
and duodenum that relates to the rate of gastric emptying. When the
contractions begin, the pylorus is generally closed, although fluid
and small particles leak through the valve. As contractions or
electrical activity corresponding to the contractions reach
pylorus, the pylorus begins to open or relax. Thus, as the stomach
churns and breaks down food in a healthy stomach, the pylorus
begins to open. As this is occurring, there may be electrical
activity in the duodenum as well. Retrograde electrical activity
from the duodenum, i.e. contractions or electrical activity in the
direction of the pylorus tends to cause the pylorus to close, thus
preventing bile and pancreatic juices from backing up into the
stomach. Accordingly, the opening and closing of the pylorus is
influenced by electrical stimulation input from both of its
ends.
[0006] In a number of disease states or conditions, the
contractions of the stomach and/or the opening and closing of the
pylorus is irregular. Gastroparesis may result from insufficient
contractions to churn food, move food through the pylorus, and/or
open the pylorus, among other things, resulting in gastro-retention
of food. In another motility disorder known as dumping syndrome,
the stomach empties at an abnormally high rate into the small
intestine causing various gastrointestinal disorders. It has also
been observed that in obese patients, gastric emptying tends to be
at a higher than normal rate. It is believed that obesity may be
treated by altering gastric motility to cause the stomach to slow
gastric emptying.
[0007] Accordingly, it would be desirable to provide a device and
method for controlling gastric emptying. Further, it would be
desirable to provide a device and method that controls the
contracting and relaxation of the pylorus according to a desired
increase or decrease in gastric emptying.
[0008] Some devices have been proposed to constrict the stomach to
reduce stomach volume. These devices are typically implanted in a
relatively invasive procedure and operate to constrict the stomach
but do not enable periodic control of the stomach emptying. Some
devices have been proposed to interfere with the peristaltic motion
of the gastrointestinal tract and especially, the stomach, to slow
the movement of food from the stomach. These devices control the
contractions of the stomach but are not directed to opening and
closing the pylorus outside of the context of controlling
peristalsis of the stomach. Furthermore, most of these devices
require open or laparoscopic surgery in which a stimulator unit is
implanted subcutaneously adjacent the abdomen wall with leads
extending to the stomach where electrodes are attached. Artificial
sphincters, for opening and closing sphincters including the
pylorus have been proposed. These devices typically involve placing
a constricting member around the sphincters in a relatively
invasive procedure.
[0009] Accordingly it would be desirable to provide a relatively
easily implanted device and method for controlling the opening
and/or closing of the pylorus. It would further be desirable to
provide a method and device for treating obesity.
BRIEF SUMMARY OF THE INVENTION
[0010] The invention provides a fixation device for holding
stimulating electrodes in electrical contact with the wall of a
portion of the gastrointestinal tract. In one embodiment, the
fixation device includes an expandable member that fixes the
electrodes in electrical contact with the gastrointestinal tract
wall. According to one embodiment, the fixation device comprises a
relatively tubular shaped structure that holds stimulating
electrodes adjacent the wall of the duodenum while permitting the
passage of materials through the device. According to another
embodiment of the invention, the fixation device comprises a
self-expanding tubular member.
[0011] The present invention further provides an implantable device
and method for controlling the opening and/or closing of the
pylorus. In particular, one embodiment comprises a device and
method for stimulating the duodenum to control the closing/and or
opening of the pylorus. According to this embodiment, electrodes
are coupled to the wall of the duodenum. In one embodiment, the
electrodes are coupled to the duodenum above the duct through which
bile and pancreatic secretions empty into the small intestine.
Electrical stimulation pulses are delivered by an electronic
circuit through the electrodes. The stimulation pulses that travel
in a deep retrograde direction end to cause the pylorus to contract
and close. The stimulation may be delivered after sensing a meal or
that food has been ingested. For example, detecting a change in
temperature due to food particles not at body temperature. Or, the
stimulation may be user activated whereby the user turns on the
device after ingesting a meal. The stimulation in one embodiment is
set to continue for a Predetermined period of time. Thus, where a
patient's typical rate of gastric emptying is greater that desired,
such emptying may be slowed using the stimulator.
[0012] The present invention also provides a method for treating
obesity by controlling the pylorus to retain food in the stomach
for a desired period of time, among other things to provide a
feeling of satiety and/or to reduce hunger. According to one
embodiment, the pylorus's contraction is controlled by electrical
stimulation of the duodenum. The retrograde propagation of the
stimulation acts to close or cause contraction of the pylorus.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a side cutaway view of a stomach and duodenum with
an implanted stimulator according to an embodiment of the
invention.
[0014] FIG. 1A is a side view of the fixation device of the
stimulator of FIG. 1 in a compressed configuration.
[0015] FIG. 1B is a cross sectional view of FIG. 1A along the lines
13-1B.
[0016] FIG. 1C is a side view of the fixation device of the
stimulator of FIG. 1 in an expanded configuration
[0017] FIG. 1D is a cross-sectional view of FIG. 1C along the lines
1D-1D.
[0018] FIG. 1E is a top view of a portion of the stimulator
illustrated in FIG. 1A.
[0019] FIG. 1F is a schematic side view of the electrode housing of
the stimulator of FIGS. 1, and 1A-1E.
[0020] FIG. 2 is an alternative electrode housing for the
stimulator of FIG. 1 in which electronics are encased in the
electrode housing.
[0021] FIG. 3 illustrates another embodiment of an implanted
stimulator according to the invention.
[0022] FIG. 4 illustrates another embodiment of an implanted
stimulator according to the invention.
[0023] FIG. 4A is a side view of the fixation device of the
stimulator of FIG. 4 in an expanded configuration with a removable
replaceable battery unit coupled to the electrode housing.
[0024] FIG. 4B is a side view of the electrode housing and
removable battery unit of the stimulator of FIG. 4A.
[0025] FIG. 4C is an enlarged portion of FIG. 4B as indicated in
FIG. 4B.
[0026] FIG. 5 is a schematic of an electronic circuit of a
stimulator according to an embodiment of the invention.
[0027] FIG. 6 is a schematic of an external controller circuit
according to an embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0028] Referring to FIGS. 1 and 1A-1F a stimulator 30 in accordance
with the invention is illustrated implanted in the gastrointestinal
tract of a patient. The stimulator 30 comprises a fixation device
34 to be implanted in the duodenum 24 and an electronics housing 50
to be located in the stomach 20 and coupled by wire tube 53
enclosing leads 51, 52, to the fixation device 34. The fixation
device 34 includes electrodes 41, 42 in electrical contact with the
duodenum 24 and the electronics housing 50 includes electronic
circuitry 125 and a battery 144 that supply electrical stimulation
pulses to the duodenum 24 through the electrodes 41, 42.
[0029] In FIG. 1, the fixation device 34 is illustrated in place in
the duodenum 24 located adjacent the pylorus 23 of a patient and
above the duct 25 (where the ducts for bile and pancreatic
secretions merge). The electrodes 41, 42 of the fixation device 34
are contained in an electrode housing 43 (FIG. 1A) and exposed at
the outer circumference of the fixation device 34 so that the
electrodes 41, 42 may be positioned in electrical contact with the
wall 27 of the duodenum 24. The fixation device 34 operates to
engage the inner circumference of the wall 27 of the duodenum 24 to
hold and maintain the electrodes 41, 42 in electrical contact with
the duodenum 24. The fixation device 34 comprises a plurality of
rings 36 including undulating members 37 having peaks and valleys
that permit compression and expansion of the rings 36.
[0030] The rings 36 are preferably formed of Nitinol to provide
spring-like properties with sufficient radial strength so that they
may be compressed and constrained by a catheter containing the
fixation device 34, and released from the catheter to expand into
an expanded engaging position within a lumen of the
gastrointestinal tract. The rings 36 define a common axis 39
extending through the rings 36. The rings 36 are attached to each
other by way of the electrode housing 43, which is molded onto the
rings 36 along the axis 39 of the rings 36. Each ring 36 is formed
by a closed wire loop of undulating members 37 and includes a
straight portion 38 over which the electrode housing 43 is molded.
The electrode housing 43 may be formed of a biocompatible plastic
such as polyurethane or polycarbonate. The fixation device 34
further defines a lumen 45 extending along the axis 39 through
which materials from the stomach 20 may pass.
[0031] The fixation device 34 may be delivered in a compressed
configuration to the duodenum 24 through a catheter or the like,
containing the fixation device 34 in its compressed state. The
fixation device is then expanded into a configuration in which it
engages the wall 27 of the duodenum 24. As illustrated in FIGS. 1A
and 1B, in a compressed position, the diameter of the fixation
device 34 is relatively small so that it can reside with in a
catheter of sufficiently small diameter to be placed through upper
gastrointestinal tract (i.e., into the mouth of a patient, through
the esophagus and stomach, and through the pylorus into the
duodenum). The catheter may include a retractable sheath containing
the fixation device 34. The sheath is retractable upon locating the
catheter in a desirable position for deployment of the fixation
device 34 in the duodenum 24. This may be guided by an endoscope or
fluoroscopy. The fixation device 34 should be position in an orad
location from the duct 25 where the bile and pancreatic secretions
empty into the duodenum 24 so that the fixation device 34 does not
block the duct 25. When retracted, the sheath permits the
self-expanding rings 36 of the fixation device 34 to expand to the
expanded position illustrated in FIGS. 1C and 1D. Thus, when
released from the catheter, the fixation device 34 expands to
engage the inner circumference of the wall 27 of the duodenum 24.
In its expanded position, the circumference of the fixation device
34 increases while the electrode housing 43 and the straight
portion 38 of each ring 36 encased by the electrode housing 43
maintain their original size and shape. The radial strength of the
rings 36 serves to hold the fixation device 34 in place. The
electrodes 41, 42 are located on the outer surface 44 of the
electrode housing 43 and the rings 36 hold them in place against
the wall 27 of the duodenum 24 to provide electrical contact
therewith. Alternatively, the rings 36 may be expandable by a
balloon catheter or the like.
[0032] A pair of leads 51, 52 encased in a tube 53 extend out of
the fixation device 34 and are coupled to the electronics housing
50--When the fixation device 34 is deployed, the tube 53. and
electronics housing 50 extend in an orad direction, through the
pylorus 23 and into the stomach 20. The electronics housing 50 is
attached to the stomach 20 wall leaving sufficient slack in the
tube 53 to allow for stomach contractions and movement. In this
embodiment, the electronics housing 50 contains a battery 144 and
electronic circuitry 125 (FIG. 5) for providing electrical
stimulation to the duodenum 24 through the leads 51, 52 extending
thorough tubing 53 and coupled to the electrodes 41, 42. FIG. 5
illustrates exemplary electronics 125 and battery 144 that may be
used with the stimulator 30 or stimulators of other embodiments of
the invention, such as, for example, those described herein. The
electronics housing 50 also includes a sensor 51 (or plurality of
sensors) that may be provided with the capability of sensing one or
more of various parameters of the gastrointestinal tract such as,
e.g., pressure, temperature, pH, and relative movement (e.g., using
an accelerometer).
[0033] The electronics housing 50 may be delivered into the stomach
and coupled to the fixation device 34 in a number of manners. With
the fixation device 34 in position in the duodenum 24, the
electronics housing 50 may be delivered to the stomach and attached
to the fixation device through the wire tubing 53 extending between
the stomach 20 and the duodenum 24 by connecting the wire tubing of
a first portion 53a attached to the fixation device 34, to a second
portion 53b of the wire tubing 53 coupled to the electronics
housing 50. The first portion 53a has a free end 54 with a
connector 55 and an attached end 56 attached to the electrodes 41,
42 through the electrode housing 43 on the fixation device 34.
[0034] The second portion 53b includes an attached end 59 coupled
to the electronics housing 50 and a free end 57 having a connector
58 that will mate with the connector 55 on the free end 54 of the
first portion 53a to provide a connected electrical leads between
the electrode housing 43 and the electronics housing 50. The
electronics housing 50 is secured to the stomach wall with an
attachment mechanism 52 and so that the tube 53 has sufficient
slack to permit stomach churning, while not damaging or pulling the
housing 50, fixation device 34 or tube 53. The attachment mechanism
52 prevents the housing 50 from moving through the pylorus 23. The
attachment mechanism 52 comprises an elongate flexible member 45
attached to the housing 50 and extending through the stomach wall
and having a T-shaped end 46 that attaches the elongate member 45
to the stomach wall.
[0035] The electronics housing 50 may be delivered into the stomach
and attached to the stomach wall using a needle into which the
T-shaped end 46 is loaded. The needle pierces the stomach wall and
releases the T-shaped end 46. The housing 50 is then attached to
the fixation device 34 by using grasping tools extending through
tool channels of an endoscope, to attach connectors 55 and 58. The
electronics housing 50 may also be detached from the fixation
device 34 through connectors 55, 58 so that the battery 144 and/or
electronics125 may be replaced. While the electronics housing 50
and fixation device 34 are illustrated as being connected after the
fixation device 34 and electrode housing 43 have been deployed, the
electronics housing 50 may also be deployed through the catheter in
a connected position with the fixation device before or after the
fixation device 34 has been positioned and deployed. A catheter
accommodating a needle to attach the attachment device 52 and a
deployment mechanism for the fixation device 34 would need to be
accommodated in a catheter designed for the multiple tasks
involved.
[0036] The electronics housing 50 has a round smooth shape that
will minimize any trauma to the stomach. The electronics housing 50
is also of a sufficient size that it will not be passed through
pylorus 23 into the duodenum 24. It is further constructed of a
material that resists corrosion in the highly acidic stomach
environment. Such corrosion resistant materials may include, for
example, an acid corrosion resistant material such as a suitable
inert polymer, for example, materials from the Polyolefin family
like HDPE (high density polyethylene), LLDPE (linear low density
polyethylene), and UHMWPE (ultra high molecular weight
polyethylene); fluoropolymer materials like PTFE' (poly
tetrafluoroethylene), FEPTM (fluorinated ethylene propylene) and
others; polymethylpentene, and polysulphons; some elastomers such
as thermoplastic polyurethanes and C-Flex type block copolymers
that are stable in acidic environments. Additionally the
electronics housing 50 may be constructed of an acid corrosion
resistant metal such as Platinum, Gold, Tantalum, Titanium, or
suitable alloys thereof.
[0037] Referring to FIG. 5, the electronics 125 and battery 144 are
illustrated that may be used with the various embodiments of the
stimulator described herein. The electronic circuitry may be on a
chip or otherwise have a standard configuration that may be used in
a number of different embodiments of the stimulator device. In
general, the electronic circuitry includes a controller that
delivers electrical stimulation pulses through the electrodes to
the wall of the duodenum, the stimulation tends to cause the
pylorus 23 to close. The stimulation may be actuated by a user upon
ingesting food and the stimulation may continue for a predetermined
period of time thereafter. In one embodiment the stimulation
parameters are preprogrammed into the controller. The stimulation
device may also be provided with the capability of sensing various
parameters of the gastrointestinal tract such as, e.g., pressure,
temperature and relative movement (e.g., using an accelerometer).
The parameters may be used to determine various conditions, for
example, patient is awake, sleeping and the type, period, or other
parameters of stimulation may be modified according to a program or
by a user or health care provider. The electronic circuitry 125 of
the stimulator is located in the stimulator housings of the various
implants described herein such as, for example, a subcutaneously
implanted stimulator unit; a stimulator unit included with the
fixation device; a removable attachable housing that may be
attached to the fixation device; or in a another housing located
within the gastrointestinal tract (e.g., the stomach) and attached
by way of leads to the fixation device. Likewise, the battery 144
that powers the electronic circuitry 125 may be located in a number
of different housings in various embodiments and configurations of
the stimulator. In these different locations, the battery 144 may
be removable and replaceable with the electronic circuitry 125 or
on its own in a modular device. If the stimulator is included with
the fixation device, the battery may also be removably and
replaceably attachable to the electronics or electrode housing on
the fixation device. The battery 144 may be located with the
electronic circuitry 125 attached by way of leads to the
stimulator.
[0038] The stimulation of the duodenum occurs for a predetermined
period of time after which the stimulation is discontinued to allow
emptying of the stomach. The circuitry 125 of one embodiment as
illustrated in FIG. 5 comprises: a microprocessor or controller 140
for controlling the operations of the electronic circuitry 125, and
an internal clock 141. The circuitry 125 may also include a battery
device 144 such as a pair of lithium iodine batteries for powering
the various components of the circuitry 125. Alternatively, the
battery device 144 may be housed in a separate unit that may be
coupled to the circuitry 125. As such, the controller 140 and
battery device 144 are coupled to each of the major components of
the circuit as would be apparent to one of ordinary skill in the
art. The controller 140 is coupled to stimulation driver 142, which
is coupled to stimulating electrodes 41, 42 (or any of the other
electrodes described herein) that are used to provide electrical
stimulation in accordance with programmed parameters.
[0039] The controller 140 is coupled to ROM 143, which contains the
program instructions for the controller 140 and any other
permanently stored information that allows the
microprocessor/controller 140 to operate. The controller 140
addresses memory in ROM 143 through address bus 143a and the ROM
143 provides the stored program instruction to the controller 140
via data bus 143b. The controller 140 controls the RF coil 145,
which communicates with an external control or programming device
160 (FIG. 6), preferably via a modulated RF signal. Processor 140
is coupled to a buffered oscillator 151 that provides an RF signal
to be emitted from the RF coil 145. The RF signal is preferably at
about 100 kHz to 5 MHz so that the signal is efficiently
transmitted through tissue. The controller 140 controls the
oscillator 151 and may provide data to be modulated with the RF
signal to be delivered through the RF coil 145. Such data may
include, for example, data sensed by a sensor 51 located on the
electronics housing 50 (or alternatively the fixation device 34),
such as pressure, pH, temperature, movement (accelerometer), or
sensed electrical information such as impedance, electrical
activity (EMG) etc. One or more sensors 147a (e.g., accelerometer),
147b (e.g., pressure), 147c (e.g., pH), 147d temperature, or
electrodes--41, 42 (for sensing EMG, EGG, or impedance as well as
providing stimulation), may be coupled to the controller 140
through A/D converters (with amplifiers) 146a, 146b, 146c, 146d,
146e which convert a representative analog electrical signal into a
digital signal. Suitable types of these sensors are generally known
in the art and may be located within, on, or external to the
electronics housing 50, fixation device 34 or electrode housing 43
on the fixation device 44. When the RF coil 145 is receiving an
external telemetry signal, the buffered oscillator 151 is disabled.
Telemetry signals received on the RF coil 145 are detected in a
detector circuit 151a and to communicated controller 140. The
detector circuit 151a is preferably selected based on the
modulation used for telemetry signals. The sensed parameters may
indicate e.g. the ingestion of food or activity level of a patient.
Pacing may be turned on or off based on these parameters.
[0040] Controller 140 is coupled to RAM 150 via an address bus 150a
for addressing a location in RAM 150 and a bi-directional data bus
150b for delivering information to and from RAM 150. The RAM 150
includes event memory 148 that temporarily stores data recorded by
sensors 147a-d or electrodes 41, 42 (or other--electrode pairs
described herein). RAM 150 also includes a programmable memory 149
which may be programmed, for example, by an external programmer
160. The data stored in the programmable memory may include
specifications for the electrical stimulation operating modes or
parameters. Such programming may be done in response to sensed
information or it may be done automatically by an external
controller or as desired by a treating physician, etc. Sensed data
acquired from sensors 147a-d and electrodes 41, 42 or other
electrode pairs described herein, provided to the controller 140
may be stored in event memory 148 in the RAM 150. The data stored
in the event memory 148, may be sent intermittently as data bursts
via the RF coil 145, as opposed to continuously in order to save
battery power.
[0041] The electrode 41, 42 outputs are used to provide electrical
stimulation delivered through the stimulation driver 142 to the
electrode 41, 42. The stimulation modes and parameters may be
pre-programmed or may be set using the external programmer 160 or
in response to sensory feedback. The same electrode outputs may be
used to sense impedance through impedance circuit 153 and to sense
electrical activity, which is delivered through A/D converter 146e.
The electrodes 41, 42 are coupled through coupling capacitors 155a
and 155b respectively, to the output of electrical stimulation
driver 142 and the inputs of A/D converters 146e, 146f.
[0042] The impedance circuit 153 comprises a constant current
source oscillator 154 that oscillates at a frequency of 50-100 kHz,
and an A/D converter 146f coupled to the controller 140. The
oscillator 154 provides a constant current source through
electrodes 41, 42 resulting in a voltage across the electrodes 41,
42 that is representative of impedance, in view of the constant
current. The voltage is provided through and is converted by A/D
converter 146f to a digital signal representative of impedance. A/D
converter 146f has a bandwidth that includes the 50 kHz frequency
signal while filtering out the electrical stimulation signal that
is delivered to the electrodes 41, 42 through electrical
stimulation driver 142, and the EMG signal that is sensed by the
electrodes 41, 42. Both of the outputs are filtered out by A/D
converter 146f A/D converter 146e has a bandwidth that filters out
the 50-100 kHz signal. Further, when a stimulation signal is being
delivered, the controller 140 does not receive signals from A/D
converters 146e and 146f. Thus the EMG and impedance sensing
functions and the stimulation delivery functions are separated
through the electronic circuitry 1-25, though using the same
electrodes.
[0043] The battery 144 has its output supplied to a DC-to-DC
converter 144a to provide a higher voltage, which is utilized for
electrical stimulation pulses. The DC-to-DC converter 144a is
conventional and provides an output voltage of 15 to 20 volts.
[0044] FIG. 6 illustrates the electronic circuitry 163 for external
programmer 160. The electronic circuitry 163 comprises: a
microprocessor or controller 170 for controlling the operations of
the electronic circuitry, an internal clock 171, and a power source
174 such as a battery device for powering the various components of
the circuit 163. As such, the controller 170 and battery device 174
are coupled to each of the major components of the circuit as would
be apparent to one of ordinary skill in the art. The controller 170
may be coupled to a speaker 167 for that provides audible alerts
and a display 166 such as a CRT to display data such as recorded
data, sensed parameters, treatment parameters and status of the
device (e.g. position or battery charge status). The controller 170
is coupled through a buffer 164 to external input device 165 that
is used to provide program parameter `input, e.g. from a user, for
a user to request data displayed in a desired format through
display 166 or speaker 167, or to turn the device on and off. The
external programmer 160 is also provided with an external data port
168 to interface with a computer and provide a means for
bi-directional communication of data or commands. The computer may
provide programming or data to the controller/microprocessor 170. A
user may also interface with the computer to provide treatment
protocols or changes in protocols, etc. Also, a user may control
the turning on and off of the stimulation program.
[0045] The controller 170 is coupled to ROM 173, which contains the
program-instructions for the controller 170 and any other
permanently stored information that allows the
microprocessor/controller to operate. The controller 170 addresses
memory in ROM 173 through address bus 173a and the ROM 173 provides
the stored program instructions to the controller 170 via data bus
173b. The controller 170 controls the RF coil 175, which
communicates with stimulator electronic circuitry 125 (FIG. 5)
through its RF coil 145. Processor 170 is coupled to an oscillator
172 that provides an RF signal, preferably having a characteristic
frequency of 500 kHz or higher, to be emitted from the RF coil 175.
The controller 170 controls the oscillator 172 and provides data to
be modulated with the RF signal, for example, programming
information, stimulation parameters, etc. The RF coil 175 also
receives information transmitted via RF signal from RF coil 145 on
the stimulator electronic circuitry 125 such as various sensed
data, e.g., pressure, pH, impedance, electrical activity (EMG) etc.
The received RF signal is passed through demodulator 176 and is
transmitted to the controller 170. The data is delivered to the
event memory 178 in RAM 177 by way of data bus 177b for temporary
storage. The data may be retrieved from RAM 177 by addressing the
storage location via the address bus 177a.
[0046] Event memory 178 temporarily stores data recorded by sensors
147a-147e and electrodes 41, 42 and delivered via telemetry to the
external programmer 160, until the data is downloaded onto a
computer using the external data port 168. The RAM 177 also
includes a programmable memory 179 which may be programmed, for
example, to specify operating modes such as waveform, frequency,
etc. which programming is then telemetrically communicated to the
stimulator electronic circuitry 125. The modes and parameters can
either be set using an external programmer 160 or set in response
to sensory feedback.
[0047] In an alternative embodiment, the device includes a housing,
electrodes and minimal electronics and an electromagnetic coil.
This device is powered by an external electromagnetic coil, which
is placed on the patient's abdomen near the implanted device. The
electrical stimulation parameters are controlled real-time by an
external unit.
[0048] Referring to FIG. 2, an alternative stimulator 70 having an
alternative electronics/electrode housing 73 is illustrated. The
stimulator 70 comprises a fixation device 75 with a housing 73 for
the electrodes 81, 82. The fixation device 75 is similar to
fixation device 34 described above with reference to FIGS. 1-1F.
The housing 73 in this embodiment also contains the electronics
125. The electrodes 81, 82 are coupled to the electronic circuitry
125 by way of connectors 83, 84. The electronic circuitry 125 is
coupled to leads 76, 77 encased in corrosion resistant wire tubing
78 that extends out of the housing 73 and fixation device 75. When
the stimulation device 70 is deployed in the duodenum 24, wire
tubing 78 similarly extends out of the duodenum 24 in an orad
direction, through the pylorus 23 and into the stomach 20--where it
is coupled to the battery 144 contained in a battery housing. The
fixation device 75 is placed in the duodenum 24 in a manner similar
to fixation device 34 described above with reference to FIGS. 1-1F.
The battery housing 74 is configured similarly to the electronics
housing 50 of FIGS. 1-1F of a corrosion resistant material and
rounded configuration, with the battery 144 but without the
electronic circuitry 125. The battery 144 is electrically coupled
through leads 76, 77 to the electronic circuitry 125 located in the
housing 73. The battery housing 74 is removable and replaceable in
a manner similar to electronics housing 50 described above with
reference to FIGS. 1-1F and the stimulation-programming and
protocol may be delivered in a similar manner as well.
[0049] Referring to FIG. 3 an alternative stimulator 30' is
illustrated comprising a fixation device 34' implanted in a
duodenum 24 in a similar manner as fixation device 34 described
above with reference to FIGS. 1-1F. In this embodiment however, the
wire tubing 53' extends out of the wall 27 of the duodenum 24, into
the abdominal cavity 28 where it is coupled to electronics housing
50' containing the electronics unit 125 and battery 144. In
implanting the stimulator 30', the fixation device 34' is placed in
the duodenum 24 and the electronics housing 50' is implanted
subcutaneously within the abdominal cavity 28. The wire tubing 53'
coupled to and extending from the electronics housing 50' is then
laparoscopically placed through the abdomen and through the wall 27
of the duodenum 24 where it is coupled through connector 44' to the
electrodes 41', 42' encased in the electrode housing 43'. The
stimulation is provided from the electronic circuitry 125 to the
inner wall of the duodenum 24 wall in a manner similar to that
described above with reference to FIGS. 1-1F, 5 and 6.
[0050] Referring to FIG. 3 an alternative stimulator 30' is
illustrated comprising a fixation device 34' implanted in a
duodenum 24 in a similar manner as fixation device 34 described
above with reference to FIGS. 1-1F. In this embodiment however, the
wire tubing 53' extends out of the wall 27 of the duodenum 24, into
the abdominal cavity 28 where it is coupled to electronics housing
50' containing the electronics unit 125 and battery 144. In
implanting the stimulator 30', the fixation device 34' is placed in
the duodenum 24 and the electronics housing 50' is implanted
subcutaneously within the abdominal cavity 28. The wire tubing 53'
coupled to and extending from the electronics housing 50L--is then
laparoscopically placed through the abdomen and through the wall 27
of the duodenum 24 where it is coupled through connector 44' to the
electrodes 41', 42' similarly encased in the electrode housing 43'
as electrodes 41, 42 are encased in housing 43 with reference to
FIGS. 1, and 1A-1F. The stimulation is provided from the electronic
circuitry 125 to the inner wall of the duodenum 24 wall in a manner
similar to that described above with reference to FIGS. 1-1F, 5 and
6.
[0051] Referring to FIGS. 4, and 4A-4C, an alternative embodiment
of the invention is illustrated. A stimulator 90 comprises a
fixation device 93 including an electronics housing 94 with
electrodes 91, 92 and electronic circuitry 125 coupled to the
electrodes 91, 92. The electronic circuitry 125 is powered by
battery 144 contained in a removable battery housing 95 that is
configured to be removably coupled to the fixation device 93 in
electrical communication with the electronics unit 125 contained in
the electronics housing 94.
[0052] In particular, the battery housing 95 includes magnets 98,
99 that may be coupled with magnets 104, 105 on the inner wall 106
of the electronics housing 94. Electrical contacts 96, 97 on the
battery housing 95 align with electrical contacts 102, 103 on the
inner wall 106 of the electronics housing 94 when the magnets 98,
99 are correspondingly aligned with magnets 104, 105 on the
electronics housing 94. When the magnets 98, 99 are aligned with
magnets 104, 105 and the battery housing is coupled to the
electronics housing 94, contacts 96, 97 are correspondingly
electrically coupled to contacts 102, 103 so that the battery 144
provides power to the electronic circuitry 125 among other things,
to deliver stimulating pulses to the duodenum 24 as described
herein with reference to FIGS. 5 and 6. As shown in FIG. 4C,
contact 96 comprises a protruding portion 107 that is positioned in
recess 108 in inner wall 106 in electronics housing 94. Contact 102
engages protruding member 107 so that electrical contact is made
with contact 96. O-ring 109 seals electrical contacts within recess
108.
[0053] While the invention has been described with reference to
particular embodiments, it will be understood to one skilled in the
art that variations and modifications may be made in form and
detail without departing from the spirit and scope of the
invention.
* * * * *