U.S. patent application number 12/754439 was filed with the patent office on 2011-02-10 for feedback systems and methods to enhance obstructive and other obesity treatments.
This patent application is currently assigned to IntraPace, Inc.. Invention is credited to Charles R. Brynelsen, Mir Imran, Rose Province.
Application Number | 20110034760 12/754439 |
Document ID | / |
Family ID | 42828741 |
Filed Date | 2011-02-10 |
United States Patent
Application |
20110034760 |
Kind Code |
A1 |
Brynelsen; Charles R. ; et
al. |
February 10, 2011 |
FEEDBACK SYSTEMS AND METHODS TO ENHANCE OBSTRUCTIVE AND OTHER
OBESITY TREATMENTS
Abstract
Feedback systems and methods enhance obstructive and other
obesity treatments by presenting feedback regarding patients'
actual eating and/or exercise habits. An ingestion restricting
implant body can be deployed along the gastrointestinal tract. In
some embodiments, ingestion alters the implant body, which, in
turn, generates signals. The generated signals can be used to
inhibit unhealthy ingestion by the patient. In other embodiments,
the implant body can be altered by signals so as to selectable
change the restriction imposed on the gastrointestinal tract,
optionally in response to ingestion events, an eating schedule, or
the like. The implant body may comprise a gastric band or an
intragastric balloon. Sensor signals may be processed to identify
ingestion and/or characterize ingestion of a solid or a liquid, and
the results may be displayed on a screen for a patient or coach to
view.
Inventors: |
Brynelsen; Charles R.;
(Menlo Park, CA) ; Imran; Mir; (Los Altos Hills,
CA) ; Province; Rose; (San Jose, 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: |
42828741 |
Appl. No.: |
12/754439 |
Filed: |
April 5, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61166636 |
Apr 3, 2009 |
|
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|
Current U.S.
Class: |
600/37 ; 606/192;
607/3 |
Current CPC
Class: |
A61N 1/37247 20130101;
G16H 20/30 20180101; A61B 5/4205 20130101; A61B 5/6846 20130101;
A61B 5/02055 20130101; A61B 5/411 20130101; G16H 40/67 20180101;
G16H 20/60 20180101; A61B 5/6871 20130101; A61N 1/36007 20130101;
A61B 5/0022 20130101; A61B 5/076 20130101; A61B 5/486 20130101;
A61F 5/0053 20130101; A61B 5/1118 20130101; G09B 19/0092 20130101;
G16H 10/60 20180101 |
Class at
Publication: |
600/37 ; 607/3;
606/192 |
International
Class: |
A61F 2/04 20060101
A61F002/04; A61N 1/36 20060101 A61N001/36 |
Claims
1. A method for treating a patient, the patient having a
gastrointestinal tract and an unhealthy ingestion pattern, the
method comprising: deploying an ingestion restricting implant body
along the gastrointestinal tract; generating signals correlating to
altering of the implant body; and inhibiting unhealthy ingestion by
the patient in response to the signals sufficiently to modify the
unhealthy ingestion pattern toward a healthier ingestion
pattern.
2. The method of claim 1, wherein deploying the implant body
comprises bariatric surgery so as to surgically implant an implant
system for weight loss, the implant system comprising the implant
body and a processor coupled to the implant body so as to transmit
the signals therebetween.
3. The method of claim 2, wherein the implant body comprises a
gastric band defining a channel therethrough, wherein deploying the
implant body comprises positioning the band so that the
gastrointestinal tract extends through the channel of the implant
body.
4. The method of claim 3, wherein the altering of the implant body
is performed a plurality of times each day for a plurality of days
by altering an engagement force between the gastrointestinal tract
and a fluid-filled pressure bladder of the gastric band, the fluid
pressure bladder disposed between the channel and a support
structure of the gastric band.
5. The method of claim 4, wherein the altering of the engagement
force is induced each day by ingestion-related distension of the
gastrointestinal tract within the channel of the gastric band,
wherein the signals are generated by at least one sensor in
response to transient changes in fluid pressure within the bladder,
the signals indicating an ingestion event, and wherein the
inhibiting of unhealthy ingestion comprises at least one member
selected from the group consisting of: showing a display to the
patient or a lifestyle coach, the display corresponding to eating
events during the plurality of days; increasing the pressure within
the bladder; and/or electrically stimulating tissue of the
gastrointestinal tract with the implant.
6. The method of claim 5, wherein the at least one sensor comprises
one of a pressure sensor, a temperature sensor, an optical sensor,
an impedance sensor, a pH sensor, or an acoustic sensor.
7. The method of claim 6, wherein the ingestion event comprises
ingestion of a solid.
8. The method of claim 6, wherein the ingestion event comprises
ingestion of a drink.
9. The method of claim 4, wherein the signals comprise pressure
command signals transmitted to the bladder from the processor of
the implant, and wherein the altering of the engagement force is
induced by changes in fluid pressure within the bladder in response
to the pressure command signals so that the pressure within the
bladder is decreased each day to allow healthy ingestion and
increased each day to inhibit unhealthy ingestion.
10. The method of claim 3, wherein the processor is coupled to an
actuator of the gastric band, and wherein altering the implant
comprises varying a size or shape of the channel of the gastric
band with the actuator in response to signals from the processor
such that restriction of ingestion is altered.
11. The method of claim 10, wherein the actuator comprises a fluid
actuator.
12. The method of claim 10, further comprising energizing the
actuator with the signals so as to activate the gastric band and
increase restriction and decrease ingestion into the patient.
13. The method of claim 10, further comprising energizing the
actuator with the signals so as to deactivate the gastric band and
decrease restriction and allow increased ingestion into the
patient.
14. The method of claim 2, wherein the implant body comprises a
gastric balloon, and wherein the processor is coupled to an
actuator, and wherein altering the implant comprises varying a size
of the gastric balloon with the actuator in response to the signals
from the processor such that restriction of ingestion is
altered.
15. The method of claim 2, wherein the implant body comprises a
gastric balloon, wherein the altering of the implant body comprises
altering a fluid pressure within the gastric balloon.
16. The method of claim 2, further comprising delivering electrical
stimulation to an internal organ of the living body from the
implant.
17. The method of claim 2, further comprising sensing a
physiological trigger with the implant, wherein the processor
transmits the signals in response to the physiological trigger.
18. The method of claim 11, wherein the processor transmits the
signals at least in part in response to a non-physiological
trigger.
19. The method of claim 1, wherein generating of the signals
correlating to altering of the implant body is performed by a
pressure sensor coupled to the implant body such that the signals
identify pressure changes in the gastrointestinal tract, and
further comprising processing the signals so as to identify an
ingestion event, the inhibiting of the unhealthy ingestion being
performed in response to the identification of the unhealthy
ingestion event.
20. The method of claim 19, wherein the processing of the signals
is performed so as to identify peristaltic waves of the
gastrointestinal tract proximate to the ingestion restricting
implant body.
21. The method of claim 19, further comprising characterizing the
ingestion event as ingestion of a liquid in response to a pressure
change that lasts more than 10 seconds but less than 5 minutes.
22. The method of claim 19, further comprising characterizing the
ingestion event as ingestion of a solid in response to a pressure
change that lasts more than 5 minutes but less than 60 minutes.
23. The method of claim 19, further comprising sensing a
temperature signal proximate the gastrointestinal tract with a
temperature sensor, wherein the processing of the signals comprises
processing of the signals from the pressure sensor and temperature
signals from the temperature sensor by a processor so as to
characterize the ingestion event, the inhibiting of the unhealthy
ingestion being performed in response to the characterizing of the
ingestion event.
24. The method of claim 24, wherein the characterizing the
ingestion event comprises identifying ingestion of a solid in
response to a sufficiently high pressure change and sufficiently
low temperature change.
25. The method of claim 24, wherein the characterizing the
ingestion event comprises identifying combined solid and liquid
ingestion in response to a sufficiently high pressure change and
sufficiently high temperature change.
26. The method of claim 24, wherein sufficiently low pressure
change and sufficiently low temperature change are identified as no
ingestion.
27. The method of claim 24, wherein the characterizing the
ingestion event comprises identification of a liquid ingestion and
possible cheating event in response to sufficiently low pressure
change and sufficiently high temperature change.
28. A method for treating a patient, the patient having a
gastrointestinal tract, the method comprising: deploying an
ingestion restricting implant along the gastrointestinal tract;
sensing, with the implant, an ingestion into the patient;
transmitting, from the implant, signals in response to the
ingestion; and at least one member selected from the group
consisting of: displaying ingestion information and treating the
patient per the signals.
29. The method of claim 28, wherein the deploying of the implant
comprising positioning the implant so that a tissue of the
gastrointestinal tract extends through a channel of the implant
such that a size of the channel limits transmission of ingested
material along the gastrointestinal tract from upstream of the
implant to downstream of the implant.
30. The method of claim 29, wherein the deploying of the implant
comprises a laparoscopic gastric band placement procedure.
31. The method of claim 28, wherein deploying the implant comprises
positioning the implant within an interior of the stomach, the
implant having a sufficient food displacement volume to
significantly limit ingestion.
32. The method of claim 32, wherein the implant comprises a gastric
balloon.
33. A method for treating a patient, the patient having a
gastrointestinal tract, the method comprising: deploying at least a
portion of an implant along the gastrointestinal tract, the implant
having a body and a processor; identifying, during a day, an
allowed ingestion, and allowing associated ingested material to
traverse the body of the implant along the gastrointestinal tract;
identifying, during the day, an unhealthy ingestion; and
transmitting signals from the processor to the body so as to alter
a shape, compliance, and/or size of the body such that the body
restricts the unhealthy ingestion.
34. The method of claim 33, wherein the deploying of the implant
comprising positioning the implant so that a tissue of the
gastrointestinal tract extends through a channel of the implant
such that a size of the channel limits transmission of ingested
material along the gastrointestinal tract from upstream of the
implant to downstream of the implant.
35. The method of claim 34, wherein the deploying of the implant
comprises a laparoscopic gastric band placement procedure.
36. The method of claim 33, wherein deploying the implant comprises
positioning the implant within an interior of the stomach, the
implant having a sufficient food displacement volume to
significantly limit ingestion.
37. The method of claim 36, wherein the implant comprises a gastric
balloon.
38. A method for treating a patient, the patient having a
gastrointestinal tract, the method comprising: deploying an implant
along the gastrointestinal tract, the implant having a processor
and a body; identifying, during a day, an unhealthy ingestion; and
transmitting signals from the processor to the patient in response
to the identification of the unhealthy ingestion so as to inhibit
the unhealthy ingestion.
39. A therapeutic implant system for treating a patient, the
patient having a gastrointestinal tract and an unhealthy ingestion
pattern, the therapeutic implant system comprising: an ingestion
restricting implant body deployable along the gastrointestinal
tract; a signal generator coupled to the implant body so as to
generate signals correlating to altering of the implant body; and a
processor coupled to the signal generator such that, in response to
the signals, the unhealthy ingestion pattern by the patient is
inhibited in use sufficiently to modify the unhealthy ingestion
pattern toward a healthier ingestion pattern.
40. The system of claim 39, wherein the implant body comprises a
gastric band defining a channel therethrough, the gastrointestinal
tract extendible through the channel of the implant body, wherein
the gastric band comprises a fluid-filled pressure bladder disposed
between the channel and a support structure such that changes in a
fluid pressure within the fluid pressure bladder correspond with
changes in an engagement force between the gastrointestinal tract
and the gastric band.
41. The system of claim 40, wherein the signal generator comprises
at least one sensor coupled to the fluid pressure bladder, the
altering of the engagement force induced by ingestion-related
distension of the gastrointestinal tract within the channel of the
gastric band so that the signals are generated in response to
transient changes in fluid pressure within the bladder and the
signals indicate an ingestion event.
42. The system of claim 41, further comprising at least one of: a
display coupled to the processor, the display showing eating events
identified in response to the signals during a plurality of days
and configured for communicating to the patient or a lifestyle
coach; an actuator coupled to the processor so as to alter the
fluid pressure within the bladder in response to the ingestion
event; and an electrode coupled to the processor so as to stimulate
tissue of the gastrointestinal tract in response to the ingestion
event.
43. The system of claim 42, further comprising at least one of a
pressure sensor, a temperature sensor, an optical sensor, an
impedance sensor, a pH sensor, or an acoustic sensor coupled to the
processor.
44. The system of claim 40, wherein the signal generator comprises
an actuator, the signals comprising fluid pressure signals
transmitted to the bladder from the processor, and wherein the
altering of the engagement force is induced by changes in fluid
pressure within the bladder in response to the pressure signals so
that the pressure within the bladder is decreased each day to allow
healthy ingestion and increased each day to inhibit unhealthy
ingestion.
45. The system of claim 44, wherein energizing the actuator
activates the gastric band so as to increase restriction and
decrease ingestion into the patient.
46. The system of claim 44, wherein energizing the actuator
deactivates the gastric band so as to decrease restriction and
allow increased ingestion into the patient.
47. The system of claim 39, wherein the implant body comprises a
gastric balloon, wherein the altering of the implant body comprises
altering a fluid pressure within the gastric balloon.
48. The system of claim 47, wherein the signal generator comprises
an actuator, and wherein altering the implant comprises varying a
size of the gastric balloon with the actuator in response to
command signals from the processor such that restriction of
ingestion is altered.
49. The system of claim 39, further comprising an electrode coupled
to the processor so as to deliver electrical stimulation to an
internal organ of the living body.
50. The system of claim 49, wherein the signal generator comprises
a pressure sensor, and wherein the processor is configured to
process the signals to as to identify pressure changes in the
gastrointestinal tract.
51. The system of claim 50, wherein the processor is configured so
that a pressure change that lasts at least 10 seconds but not more
than 5 minutes is identified as an ingestion of a liquid.
52. The system of claim 50, wherein the processor is configured so
that a pressure change that lasts at least 5 minutes but not more
than 60 minutes is identified as an ingestion of a solid.
53. The system of claim 39, further comprising a temperature sensor
coupled to the processor so as to provide a temperature from
proximate the gastrointestinal tract thereto.
54. The system of claim 53, wherein the processor is configured so
that signals from the pressure sensor and temperature sensor are
processed to identify pressure changes and temperatures.
55. The system of claim 54, wherein the processor is configured so
that high pressure change and low temperature change is identified
as a solid ingestion.
56. The system of claim 54, wherein the processor is configured so
that high pressure change and high temperature change is identified
as a combined solid and liquid ingestion.
57. The system of claim 54, wherein the processor is configured so
that low pressure change and low temperature change is identified
as no ingestion.
58. The system of claim 54, wherein the processor is configured so
that low pressure change and low temperature change is identified
as a liquid ingestion and possible cheating event.
59. The system of claim 39, further comprising a sensor coupled to
the processor, wherein the sensor comprises an optical sensor.
60. A system for treating a patient, the patient having a
gastrointestinal tract, the system comprising: an ingestion
restricting implant body deployable along the gastrointestinal
tract; a sensor coupled to the implant body so as to transmit
signals in response to ingestion into the patient in use; and a
processor coupled to the sensor, the processor, in response to the
signals, generating output comprising at least one member selected
from the group consisting of: ingestion display signals, and
patient treatment signals.
61. A system for treating a patient, the patient having a
gastrointestinal tract, the system comprising: an implant body
deployable along the gastrointestinal tract; a processor; and an
actuator coupling the processor to the body; the processor
configured so as to identify, during a day, an allowed ingestion,
and for allowing associated ingested material to traverse the body
of the implant along the gastrointestinal tract; the processor
configured so as to identify, during the day, an unhealthy
ingestion and to transmit signals to the body via the actuator so
as to alter a shape or size of the body such that the body
restricts the unhealthy ingestion.
62. A therapeutic implant system for treating a patient, the
patient having a gastrointestinal tract and an unhealthy ingestion
pattern, the therapeutic implant system comprising: an ingestion
restricting implant body implantable along the gastrointestinal
tract; and a processor coupleable to the implant body so as to
transmit signals therebetween, wherein the signals are transmitted
in correlation with changes in a size or a shape of the implant
body in use.
63. The therapeutic implant of claim 62, wherein the implant body
has a first configuration and a second configuration, the size,
compliance, or shape of the implant body in the second
configuration being different than the size, compliance, or shape
of the implant body in the first configuration such that the
implant body has an enhanced inhibition of ingestion in the second
configuration.
64. A therapeutic implant for treating a patient, the patient
having a gastrointestinal tract and an unhealthy ingestion pattern,
the therapeutic implant comprising: an ingestion restricting
implant body implantable along the gastrointestinal tract; at least
one sensor for generating signals; and a processor coupled to the
at least one sensor and the implant body so as to transmit the
signals therebetween, wherein the signals are transmitted in
correlation with an ingestion event.
65. A therapeutic implant for treating a patient, the patient
having a gastrointestinal tract and an unhealthy ingestion pattern,
the therapeutic implant comprising: an ingestion restricting
implant body implantable along the gastrointestinal tract; at least
one sensor for generating signals; and a processor coupleable to
the at least one sensor and the implant body so as to transmit the
signals therebetween, wherein the signals are transmitted in
correlation with a physical activity event.
66. The therapeutic implant of claim 65, wherein the sensor
comprises an activity sensor.
67. The therapeutic implant of claim 65, wherein the sensor
comprises a heart rate sensor.
68. The therapeutic implant of claim 65, wherein the sensor
comprises a core body temperature sensor.
69. The therapeutic implant of claim 65, wherein the sensor
comprises a sleep detector.
70. The therapeutic implant of claim 65, wherein the signals are
transmitted by the processor to a data server.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application claims the benefit under 35 USC
119(e) of U.S. Provisional Application No. 61/166,636 filed Apr. 3,
2009; the full disclosure of which is incorporated herein by
reference in its entirety. The subject matter of the present
application is related to the following applications: U.S.
application Ser. No. 12/145,430 filed Jun. 24, 2008; U.S.
application Ser. No. 10/950,345 filed Sep. 23, 2004 (Allowed); U.S.
Application No. 61/122,315 filed Dec. 12, 2008; U.S. application
Ser. No. 12/637,452 filed Dec. 14, 2009, and U.S. application Ser.
No. ______, filed concurrently herewith and entitled "Feedback
Systems and Methods for Communicating Diagnostic and/or Treatment
Signals to Enhance Obesity Treatments" (Attorney Docket No.
026458-001210US), the full disclosures of each of which are also
incorporated herein by reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] Since the mid-seventies, the prevalence of obesity has
increased sharply for both adults and children. These increasing
rates raise concern because of their implications for Americans'
health. Being overweight or obese may increase the risk of many
diseases and health conditions, including: hypertension,
dyslipidemia (for example, high total cholesterol or high levels of
triglycerides), type 2 diabetes, coronary heart disease, stroke,
gallbladder disease, osteoarthritis, sleep apnea and respiratory
problems, and some cancers (such as endometrial, breast, and
colon).
[0003] Obesity and its associated health problems have a
significant economic impact on the U.S. health care system. Medical
costs associated with excess weight and obesity may involve direct
and indirect costs. Direct medical costs may include preventive,
diagnostic, and treatment services related to obesity. Indirect
costs relate to morbidity and mortality costs. Morbidity costs are
defined as the value of income lost from decreased productivity,
restricted activity, absenteeism, and bed days. Mortality costs are
the value of future income lost by premature death.
[0004] Many therapies are currently being investigated for
treatment of obesity and diseases associated with obesity. To date,
the widely used obesity treatments have not been shown to be ideal,
particularly for those afflicted with severe obesity. The
approaches that have been proposed range from lifestyle coaching to
major surgical therapies.
[0005] Many severely obese patients have turned to surgical
options. These surgical options include highly invasive procedures
such as stomach reduction and gastric bypass, while less invasive
procedures include the implantation of gastric bands. Another
option for the severely obese patients involves the endoscopic
placement of an intragastric balloon, a silicon balloon device that
is placed in the stomach endoscopically.
[0006] Unfortunately, patient compliance and the accuracy with
which patients report their own activities can significantly limit
the effectiveness of weight loss treatments. One of the problems
associated with the surgical procedures of gastric reduction,
gastric bypass, gastric banding and intragastric balloons revolves
around patient compliance. Even after these surgeries or endoscopic
procedures, a number of patients find ways to "cheat;" they avoid
the volume limitation imposed by stomach reduction from the
above-mentioned procedures simply by ingesting liquids or liquefied
solids that easily drain into their small intestines. For weight
loss treatment to be successful, the surgical or endoscopical
procedures should ideally be combined with lifestyle changes.
Patients' self-reporting has very often proven to be
inaccurate.
[0007] Therefore, it would be desirable to provide devices, systems
and methods that can accurately monitor and report a patient's
actual daily caloric intake as well as activity related caloric
expenditure, to be used in obesity treatment therapy. Ideally, such
a system would provide a patient, his or her physician, a lifestyle
coach, support group, and/or other caregivers the information
collected about the patient's eating and exercise habits for use in
monitoring the patient's progress and so as to present actual
behavior-based information to the patient for effective behavior
modification and greater success in achieving weight loss or health
goals.
BRIEF SUMMARY OF THE INVENTION
[0008] The present invention relates to feedback systems and
methods to enhance obstructive and other obesity treatments.
Although embodiments of the invention make specific reference to
treatment of obesity, the system and methods described herein may
be applicable to other treatments seeking patient behavior
modification, and particularly disorders in which presenting
feedback regarding patients' actual eating and/or exercise habits
is desired.
[0009] In first aspect, the invention provides a method for
treating a patient having a gastrointestinal tract and an unhealthy
ingestion pattern. The method comprises deploying an ingestion
restricting implant body along the gastrointestinal tract. Signals
are generated correlating to altering of the implant body.
Unhealthy ingestion by the patient are inhibited in response to the
signals sufficiently to modify the unhealthy ingestion pattern
toward a healthier ingestion pattern.
[0010] The signals may comprise sensor signals and/or actuation
signals. In some embodiments, ingestion alters the implant body,
which, in turn, generates signals in the form of sensor signals.
The generated sensor signals can be used to inhibit unhealthy
ingestion by the patient by activating a stimulation electrode of
the implant, enhancing the restriction, presenting documented
ingestion events to the patient or a lifestyle coach, or the like.
In other embodiments, the implant body can be altered by actuator
signals so as to change the restriction imposed on the
gastrointestinal tract, optionally in response to ingestion events,
an eating schedule, or the like. The actuator signals may induce
changes in the implant a plurality of times a day for a plurality
of days, allowing the implant to adjust dynamically so as to
facilitate healthy ingestion while inhibiting unhealthy
ingestion.
[0011] In many embodiments, the implant body will be deployed using
bariatric surgery so as to surgically implant an implant system for
weight loss. The implant system may include the implant body and a
processor coupled to the implant body. The coupling between the
processor and the implant body allows the signals to be transmitted
between these two structures, with the signals optionally being
electrical signals, optical signals, wireless telemetry signals,
mechanical signals, or the like. For example, the implant body of
the implant system will often comprise a gastric band that having a
channel that receives a patient's gastrointestinal tract therein,
and a processor coupled to the gastric band. The signals may
include sensor signals transmitted from the gastric band to the
processor in response to ingestion, and/or actuation signals
transmitted from the processor to the gastric band so as to alter a
size or compliance of the channel.
[0012] In many embodiments, the gastric band comprises a fluid
pressure bladder disposed between the channel and a support
structure of the gastric band. The gastric band is altered a number
of times each day, with an associated alteration in an engagement
force between the gastrointestinal tract and the fluid-filled
pressure bladder of the gastric band. The engagement force may be
altered by ingestion-related distension of the gastrointestinal
tract within the channel of the gastric band. At least one sensor
can generate signals in response to transient changes in fluid
pressure within the bladder, often as a result of ingestion events.
Unhealthy ingestion can optionally be inhibited by showing a
display of sensed eating events to the patient or a lifestyle
coach. In some embodiments, ingestion inhibiting therapies may be
applied in response to the sensor signals, such as by increasing
the pressure within the bladder, and/or by electrically stimulating
tissue of the gastrointestinal tract with the implant.
[0013] In many embodiments, the sensors include at least a pressure
sensor, a temperature sensor, an optical sensor, an impedance
sensor, a pH sensor, or an acoustic sensor. The ingestion event may
be ingestion of a solid or ingestion of a drink.
[0014] In some embodiments, the processor of the implant sends
pressure commands or actuator signals to the bladder to alter the
engagement force by changing the fluid pressure within the bladder.
The pressure within the bladder can be decreased each day to allow
healthy ingestion and increased each day to inhibit unhealthy
ingestion. More generally, the processor may send signals via an
actuator to alter the implant by varying the size, compliance, or
shape of the channel of the gastric band. The actuator typically
comprises a fluid actuator.
[0015] In some embodiments, the actuator is energized with signals
so as to activate the gastric band by increasing restriction and
decreasing ingestion into the patient. The actuator can also be
energized by signals in an opposite direction to deactivate the
gastric band by decreasing restriction and allowing increased
ingestion into the patient.
[0016] In many embodiments, the implant body includes a gastric
balloon, with a processor coupled to an actuator. The processor
sends signals to the actuator to vary the size of the gastric
balloon such to alter restriction of the ingestion. Altering of the
implant body includes changing the fluid pressure within the
gastric balloon.
[0017] In many embodiments, deploying the implant system delivers
electrical stimulation to an internal organ of the living body.
[0018] In many embodiments, the implant senses a physiological
trigger and the processor transmits the signals in response to the
physiological trigger. The processor transmits the signals at least
in part in response to a non-physiological trigger.
[0019] In many embodiments, a pressure sensor coupled to the
implant body identifies pressure changes in the gastrointestinal
tract. Signals are used to identify an ingestion event; an
unhealthy ingestion is inhibited when an unhealthy ingestion event
has been identified
[0020] In many embodiments, the processing of the signals
identifies peristaltic waves of the gastrointestinal tract
proximate to the ingestion restricting implant body.
[0021] In many embodiments, an ingestion event is characterized as
ingestion of a liquid in response to a pressure change that lasts
more than 10 seconds but less than 5 minutes. An ingestion event is
characterized as ingestion of a solid in response to a pressure
change that lasts more than 5 minutes but less than 60 minutes.
[0022] In many embodiments, a temperature sensor may sense a
temperature within the gastrointestinal tract and send
corresponding signals. A processor uses the signals from the
pressure sensor and temperature sensor to characterize the
ingestion event, inhibiting of the unhealthy ingestion.
[0023] In many embodiments, an ingestion event that causes
sufficiently high pressure change and sufficiently low temperature
change is identified as ingestion of a solid. An ingestion event
that causes sufficiently high pressure change and sufficiently high
temperature change is identified as a combined solid and liquid
ingestion. An ingestion event that causes sufficiently low pressure
change and sufficiently low temperature change is identified as no
ingestion. An ingestion event that causes sufficiently low pressure
change and sufficiently high temperature change is identified as a
liquid ingestion and possible cheating event.
[0024] In a second aspect, embodiments of the present invention
provide a method for treating a patient by deploying an ingestion
restricting implant along the gastrointestinal tract. The implant
senses an ingestion into the patient and transmits signals in
response to the ingestion. Based on the signals, ingestion
information is displayed and/or the patient is treated.
[0025] In many embodiments, deploying the implant includes
positioning the implant around the gastrointestinal tract so that a
tissue of the gastrointestinal tract extends through a channel of
the implant. The size of the channel limits transmission of
ingested material along the gastrointestinal tract from upstream of
the implant to downstream of the implant.
[0026] In many embodiments, the implant is deployed through a
laparoscopic gastric band placement procedure.
[0027] In many embodiments, the implant may include a gastric
balloon. Deploying the implant includes positioning the implant
inside the stomach; the implant has a sufficient food displacement
volume to significantly limit ingestion.
[0028] In a third aspect, embodiments of the present invention
provide a method for treating a patient by deploying at least a
portion of an implant along the gastrointestinal tract, the implant
having a body and a processor; identifying an allowed ingestion and
allowing the ingested material to pass though the gastrointestinal
tract; and, in response to identifying of an unhealthy ingestion,
transmitting signals from the processor to the implant so as to
alter a shape or size of the implant to restrict the unhealthy
ingestion.
[0029] In many embodiments, deploying the implant includes
positioning the implant around a gastrointestinal tract that
extends through a channel of the implant. The size of the channel
limits transmission of ingested material along the gastrointestinal
tract from upstream of the implant to downstream of the implant.
Deploying of the implant includes a laparoscopic gastric band
placement procedure.
[0030] In some embodiments, the implant includes positioning the
implant inside the stomach; the implant has a sufficient food
displacement volume to significantly limit ingestion. In this case,
the implant includes a gastric balloon.
[0031] In a fourth aspect, embodiments of the present invention
provide a method for treating a patient by deploying an implant
with a processor and a body; identifying an unhealthy ingestion;
and transmitting signals from the processor to the patient in
response to the identification of the unhealthy ingestion so as to
inhibit the unhealthy ingestion.
[0032] In a fifth aspect, embodiments of the present invention
provide a therapeutic implant system for treating a patient with an
unhealthy ingestion pattern. The therapeutic implant system
includes an ingestion restricting implant body that can be deployed
along the gastrointestinal tract, a signal generator coupled to the
implant body to generate signals correlating to altering of the
implant body, and a processor coupled to the signal generator such
that the processor can be used to inhibit the patient's unhealthy
ingestion pattern.
[0033] The signal generator may comprise a sensor that senses
ingestion (via changes in fluid pressure, temperature, or the like)
and/or an actuator that alters a size, shape, or compliance of the
implant body. In many embodiments, the implant body includes a
gastric band forming a channel that surrounds the gastrointestinal
tract. The gastric band includes a fluid-filled pressure bladder
located between the channel and a support structure, such that
changes in a fluid pressure within the fluid pressure bladder
correspond with changes in an engagement force between the
gastrointestinal tract and the gastric band.
[0034] In some embodiments, the signal generator includes at least
one sensor coupled to the fluid pressure bladder, the altering of
the engagement force induced by ingestion-related distension of the
gastrointestinal tract within the channel of the gastric band so
that the signals are generated in response to transient changes in
fluid pressure within the bladder and the signals indicate an
ingestion event.
[0035] In many embodiments, the implant system includes a display
coupled to the processor, to show eating events identified in
response to the signals and to communicate to the patient or a
lifestyle coach, an actuator coupled to the processor to alter the
fluid pressure within the bladder in response to the ingestion
event; and an electrode coupled to the processor to stimulate
tissue of the gastrointestinal tract in response to the ingestion
event.
[0036] In many embodiments, the implant system also includes at
least one pressure sensor, a temperature sensor, an optical sensor,
an impedance sensor, a pH sensor, or an acoustic sensor coupled to
the processor.
[0037] In many embodiments, the signal generator transmits fluid
pressure signals transmitted to the bladder from the processor. The
signal generator includes an actuator that induces changes in fluid
pressure within the bladder in response to the pressure signals.
Each day the pressure within the bladder is decreased to allow
healthy ingestion and increased to inhibit unhealthy ingestion.
[0038] In some embodiments, the implant system energizing the
actuator activates the gastric band so as to increase restriction
and decrease ingestion into the patient.
[0039] In some embodiments, the implant system energizing the
actuator deactivates the gastric band so as to decrease restriction
and allow increased ingestion into the patient.
[0040] In some embodiments, the implant body includes a gastric
balloon. Altering the implant body includes altering a fluid
pressure within the gastric balloon.
[0041] In some embodiments, the signal generator includes an
actuator which, in response to command signals from the processor,
causes the size of the gastric balloon to vary, to alter the
restriction of ingestion.
[0042] In some embodiments, the implant system includes an
electrode coupled to the processor so as to deliver electrical
stimulation to an internal organ of the living body.
[0043] In many embodiments, the implant system the signal generator
comprises a pressure sensor. The processor in the implant systems
processes the signals to identify pressure changes in the
gastrointestinal tract. A pressure change that lasts at least 10
seconds but not more than 5 minutes is identified as an ingestion
of a liquid. A pressure change that lasts at least 5 minutes but
not more than 60 minutes is identified as an ingestion of a
solid.
[0044] In many embodiments a temperature sensor coupled to the
processor so as to provide a temperature from inside the
gastrointestinal tract. The processor processes signals from the
pressure sensor and temperature sensor to identify pressure changes
and temperatures. The processor identifies high pressure change and
low temperature change as a solid ingestion. The processor
identifies high pressure change and high temperature change as a
combined solid and liquid ingestion. The processor identifies low
pressure change and low temperature change as no ingestion. The
processor identifies low pressure change and high temperature
change as a liquid ingestion and possible cheating event.
[0045] In some embodiments an optical sensor is coupled to the
processor.
[0046] In some embodiments a pH sensor is coupled to the
processor.
[0047] In a sixth aspect, embodiments of the present invention
provide a system for treating a patient, including an ingestion
restricting implant body deployable along the gastrointestinal
tract, a sensor coupled to the implant body so as to transmit
signals in response to ingestion into the patient in use, and a
processor, coupled to the sensor, that generates output in response
to the signals. This output includes ingestion display signals
and/or patient treatment signals.
[0048] In a seventh aspect, embodiments of the present invention
provide a system for treating a patient that includes an implant
body deployable along the gastrointestinal tract, a processor; and
an actuator coupling the processor to the body. The processor
identifies, during a day, an allowed ingestion, and allows an
associated ingested material to traverse the body of the implant
along the gastrointestinal tract. The processor identifies an
unhealthy ingestion and transmits signals to the implant body via
the actuator to alter a shape or size of the implant body to
restrict the unhealthy ingestion.
[0049] In an eighth aspect, embodiments of the present invention
provide a therapeutic implant system for treating a patient that
includes an ingestion restricting implant body implantable along
the gastrointestinal tract and a processor coupleable to the
implant body so as to transmit signals. The signals are transmitted
in correlation with changes in a size or a shape of the implant
body in use.
[0050] In many embodiments, the therapeutic implant has two
possible configurations that differ in size and shape; compared to
the first configuration, the second configuration exhibits an
enhanced inhibition of ingestion.
[0051] In a ninth aspect, embodiments of the present invention
provide a therapeutic implant system for treating a patient that
includes an ingestion restricting implant body implantable along
the gastrointestinal tract, one or more sensors for generating
signals that are transmitted in correlation with an ingestion
event, and a processor coupled to the one or more sensors and the
implant body so as to transmit the signals.
[0052] In a tenth aspect, embodiments of the present invention
provide a therapeutic implant system for treating a patient that
includes an ingestion restricting implant body implantable along
the gastrointestinal tract, one or more sensors for generating
signals that are transmitted in correlation with physical activity
event, and a processor coupled to the one or more sensors and the
implant body so as to transmit the signals.
[0053] In some embodiments the sensor includes an activity
sensor.
[0054] In some embodiments the sensor includes a heart rate
sensor.
[0055] In some embodiments the sensor includes a core body
temperature sensor.
[0056] In some embodiments the sensor includes a sleep
detector.
[0057] In many embodiments of the therapeutic implant, the signals
are transmitted by the processor to a data server.
BRIEF DESCRIPTION OF THE DRAWINGS
[0058] FIG. 1 shows an exemplary system 100 suitable for
implementation of embodiments of the present invention.
[0059] FIG. 1A shows an exemplary gastric band sensor system
implant 900 for use in the system of FIG. 1.
[0060] FIG. 1B-D illustrate the electrical stimulation component of
the gastric band sensor system implant 900.
[0061] FIGS. 2A-2C illustrate alternative embodiments of system
900.
[0062] FIG. 2D shows an embodiment of system 900 comprising two
pressure sensors 928 coupled to the fluid-filled cuff 903.
[0063] FIG. 2E shows an alternative embodiment of system 900
comprising at least two lap bands, each lap band comprising at
least one sensor 926.
[0064] FIG. 3 illustrates ingestion of food or drink into a
stomach.
[0065] FIG. 3A shows a cross-sectional view of the superior portion
of the stomach constricted by a lap band 902 with a fluid filled
cuff 903.
[0066] FIGS. 4A-4C show the pressure waveforms from pressure sensor
signals one might expect with food or drink input. More
specifically, FIG. 4A shows the expected pressure waveforms from an
ingestion of food 1000. FIG. 4B illustrates an overeating event.
FIG. 4C shows the expected pressure waveforms 1200 from a drinking
event.
[0067] FIG. 5 shows the pressure waveforms 1300 that occur with
injection of fluid, e.g. saline, into the port of the lap band.
[0068] FIG. 6 shows pressure waveforms from peristaltic waves
1400.
[0069] FIG. 7 shows an exemplary intragastric
balloon-sensor-monitor system 1500.
[0070] FIG. 8 shows a method of treating a patient with an
unhealthy ingestion pattern 2000.
[0071] FIG. 8A-E show alternative treatments method comprising the
therapeutic implant.
[0072] FIG. 9 schematically shows a system and method for
classification of ingestion events based on signals from a
plurality of sensors.
DETAILED DESCRIPTION OF THE INVENTION
[0073] The present invention often takes advantage of processors to
enhance obesity therapies that rely on restrictive implants
disposed along the gastrointestinal tract. Some embodiments of the
present invention relate to feedback systems and methods for
communicating implanted sensor-based information so as to affect
behavior modification for eating disorders. Some embodiments of the
present employ systems which alter a restrictive implant in
response to signals. Although embodiments of the invention make
specific reference to treatment for obesity, the system and methods
described herein may be applicable to any treatment in which
presenting feedback regarding patients' eating and/or exercise
habits is desired.
[0074] Embodiments of the present invention collect information
regarding the patient's eating and exercise habits via one or more
sensors implanted within the body of the patient. This information
can then be reviewed by a clinician during office visits and used
in coaching the patient. Coaching may include helping the patient
to make healthy lifestyle choices, such as specifically encouraging
the patient to decrease his or her caloric intake while increasing
his or her caloric expenditure. Compliance with physician advice
may be low in obese patients and caloric intake is often
under-reported while caloric expenditures are often over-reported.
Although eventually weight gain or loss by a patient will indicate
the accuracy of the patient's reporting, the objective monitoring
systems provided herein will significantly improve many patients'
ability to acknowledge their actual behavior, to identify elements
of their behavior that can be changed to improve health, and to
effect incremental changes toward achieving long term health goals.
The implantable sensors will often detect eating events, solid
versus liquid intake, and optionally even meal compositions. The
various implantable sensors can be implanted at the same time as
the surgical procedures so as to minimize the number of surgical or
endoscopic interventions in the patients. The systems and methods
described herein may identify eating and other behaviors which the
patient is not aware of (including night-time eating and the like).
These systems and methods may also improve the correlation between
positive patient behavior and beneficial positive reinforcement,
and decrease deleterious correlations between negative patient
behavior (such as under-reporting of actual ingestion,
over-reporting activity levels, and the like) with misguided
positive reinforcement. Such improvements may be particularly
effective at promoting and/or maintaining healthy activities when
ultimate health goals remain distant.
[0075] The sensor and feedback system of the present invention is
not subject to the reporting bias of the patient, thus presenting
an objective view. In addition, embodiments of the present
invention allow data to be collected twenty-four hours per day,
seven days per week, which provides an accurate record of the
patient's behavior without dependence upon the patient's memory or
commitment to the eating and exercise tracking process. Some
embodiments may sense and/or restrict caloric intake, such as using
a band implanted around the stomach so as to constrict flow along
the gastrointestinal tract, a gastric balloon inflated within the
stomach, or the like. In still other embodiments, the present
invention also provides stimulation of the stomach to reduce
caloric intake.
[0076] Embodiments of the invention provide a system that accesses
the data collected by the implanted system remotely. The system is
then accessible by the patients and/or the patients' health coaches
to support the patient in achieving their weight reduction goals.
The automated availability of behavior modification feedback,
shortened time between "coaching sessions" and increased accuracy
of the sensor data will improve outcomes for the patients.
[0077] In some embodiments, the invention may employ aspects of
social networking systems, with sensor-based information that has
been generated using signals from an implanted sensor often being
available to one or more members of a group. The group may, at
least in part, be defined by the patient giving permission to
particular individuals. Other members of the group (such as the
patient and a supervising physician) may be defined when the group
is first organized. Many patients having implanted sensors may join
a mutual support group of patients, with sensor-based data being
shared between the implant recipients. Advantageously, these
systems may allow patients to receive feedback within a relatively
short time after exhibiting behavior that is sensed by the sensor,
preferably within two days of the sensor identifying an eating
event or activity level, and ideally within one day of the
behavior. Using telemetry-based communication between the implanted
device and a home monitor (or other intermediate device), some
embodiments may to allow daily uploads, and/or send messages to a
smartphone or personal digital assistant (PDA) in near real time.
This significant shortening of the time delay between patient
behavior and relationship-based feedback to the patient may provide
significant advantages over feedback provided through monthly,
quarterly, or annual appointments with a dietitian or physician.
Nonetheless, communication enhancement described herein may provide
efficacy benefits for alternative embodiments that rely on
uploading of patient data during such routine appointments.
[0078] To facilitate the relationships employed for implant patient
feedback, embodiments of the invention may make use of aspects of
Web-2.0 systems such as FaceBook.TM. social networking systems and
methods, MySpace.TM. social networking systems and methods, Linked
In.TM. social networking systems and methods, or the like.
Embodiments may also employ aspects of known weight reduction
support group systems and methods, particularly those that are
enhanced through electronic telecommunications such as the
WeightWatchers.com.TM. weight management portal,
TheDailyPlate.com.TM. nutrition and weight management system, and
the like. The sensor data sharing aspects of many embodiments may
employ systems somewhat analogous to (and/or may be modified from)
web-enabled athletic training community systems such as those of
TrainingPeaks.com.TM., EnduranceNation.us.TM.. Still further
aspects of the invention may be facilitated by systems and methods
that have been developed (and are continuing to be developed,
and/or will be developed in the future) in support of Health 2.0
concepts. Hence, embodiments of the inventions described herein may
leverage or be modified from a variety of known technologies,
including by employing Elgg tools and solutions for creation of
online communities as available at http://elgg.org.
[0079] An example system 100 suitable for implementation of
embodiments of the present invention is illustrated in FIG. 1. In
the embodiment shown, the system 100 comprises an implanted device
110 that communicates with a home monitor 120 via a wireless
transmitter 112, such as an RF telemetry module. The implanted
device 110 includes at least one sensor 114 and, optionally,
stimulation circuitry 116 for providing therapeutic stimulation to
the patient. A server 130 communicates with home monitor 120 via an
internet or other telecommunication system so as to allow access to
sensor-based data via a portal 150 and/or health coach workstation
160, thereby providing sensor-based feedback to a patient 140
(through direct presentation of the sensor-based information to the
patient, and/or through a health-coach/patient relationship).
[0080] Each of implanted device 110, home monitor 120, server 130,
health coach workstation 160, and a portable patient device will
typically include associated data processing systems, with the
overall feedback system 100 combining their data manipulation and
communication capabilities into an overall data architecture.
Generally, the data processing systems included in the discreet
devices of the invention may include at least one processor. For
implantable device 110, this will typically include circuitry
implanted in the patient. Other devices of system 100 will include
circuitry external of the patient. Such external processor
circuitry may include one or more proprietary processor boards,
and/or may make use of a general purpose desktop computer, notebook
computer, handheld computer, smart phone, or the like. The external
processor may communicate with a number of peripheral devices
(and/or other processors) and these peripheral devices may include
a data and/or programming storage subsystem or memory. The
peripheral devices may also include one or more user interface
input devices, user interface output devices, and a network
interface subsystem to provide an interface with other processing
systems and networks such as the Internet, an intranet, an and/or
the like. Implanted circuitry of the processor system may have some
of the constituent components described above for the external
circuitry as well being coupled to an implanted battery or other
power source, with the implanted circuitry generally employing
processors, data and software storage, and wireless communication
capabilities (although hard-wired embodiments or other
transcutaneous data transmission techniques could also be
employed).
[0081] Both external and implanted memory of the devices of system
100 will often be used to store, in a tangible storage media,
machine readable instructions or programming in the form of a
computer executable code embodying one or more of the methods
described herein. The memory may also similarly store data for
implementing one or more of these methods. The memory may, for
example, include a random access memory (RAM) for storage of
instructions and data during program execution, and/or a read only
memory (ROM) in which fixed instructions are stored. Persistent
(non-volatile) storage may be provided, and/or the memory may
include a hard disk drive, a compact digital read only memory
(CD-ROM) drive, an optical drive, DVD, CD-R, CD-RW, fixed or
removable flash memory, memory sticks, solid-state removable
memory, and/or other fixed or removable media cartridges or disks.
Some or all of the stored programming code may be altered after
implantation and/or initial use of the device to alter
functionality of the system.
[0082] The functions and methods described herein may be
implemented with a wide variety of hardware, software, firmware,
and/or the like. In many embodiments, the various functions will be
implemented by modules, with each module comprising data processing
hardware and associated software configured to perform the desired
function. The modules may be largely integrated together so that a
single processor board runs a single integrated code for each
device, but will often be separated so that, for example, more than
one processor board or chip or a series subroutines or codes are
used. Similarly, a single functional module may be separated into
separate subroutines or be run in part on separate processor chip
that is integrated with another module. Hence, a wide variety of
centralized or distributed data processing architectures and/or
program code architectures may be employed within different
embodiments.
[0083] The electronic circuitry of the various devices of system
100 communicates via RF wired or wireless networking, and/or via
telecommunications linkages for coordinating the presentation of
sensor-based feedback from implanted device 110 to patient 140, as
well as to monitor and facilitate the various operations of the
devices, including sensing, stimulating, signal transmission,
charging and/or using energy from a battery device for powering the
various devices, and the like. In some embodiments, the electronic
circuitry of one or more of the devices includes an internal clock.
The internal clock may also include a real time clock component.
The internal clock and/or real time clock may be used to control
stimulation, e.g., by stimulating or allowing stimulation at a
particular time of the day. The real time clock component may also
provide a date/time stamp for detected events that are stored as
information in a memory device, including sensor-based events,
patient presentation events (such as accessing portal 150,
receiving a text message, communicating with a health coach or
group member, or the like). Optionally, the memory may be preserved
by saving information corresponding to an event of interest which
is saved along with the time/date when the event occurred.
[0084] Sensor 114 is coupled to the stomach so as to generate
signals responsive to ingestion, with the sensor ideally comprising
at least one temperature sensor for sensing temperature information
from within the stomach. The sensors may be located on or extend
from a housing of implanted device 110 and/or the sensors may be
located on or extend from a lead or other device. Alternatively or
additionally, a sensor may be located separately on the stomach
wall and/or a sensor may be otherwise positioned elsewhere within,
coupled to or in communication with the patient. In some
embodiments, data obtained from the sensor may be pre-processed to
remove noise or unwanted artifacts before it is analyzed.
Additional sensors may be included, including an accelerometer
and/or a heart rate sensor to measure patient activity or the like.
The housing of implanted device 110 will typically contain a
battery and circuitry of the implanted device, and may be similar
to other known implantable stimulator housing structures used for
heart pacemaker systems and the like. A suitable heart rate sensor
may comprise an electrode or other sensor engaging the stomach wall
so as to receive far field electric signals from the heart.
Optionally, such a heart rate sensor may employ the same electrode
as used to stimulate stomach tissue to inhibit ingestion, though
separate electrodes may alternatively be used. Heart signals,
accelerometer signals, and/or other activity sensor signals may,
like temperature or other ingestion sensor signals, be processed
and recorded using circuitry 116. Suitable sensors and implantable
devices, as well as aspects of the other devices of the devices of
system 100, are described in (and/or may be modified from those
described in) U.S. patent application Ser. No. 12/145,430, filed on
Jun. 24, 2008 and U.S. patent application Ser. No. 10/950,345,
filed on Sep. 23, 2004, both of which have previously been herein
incorporated by reference. Processing of sensor signals so as to
identify or classify ingestions events and/or patient activity
level to be communicated by system 100 (which may occur partially
or entirely in implanted device 110, home monitor 120, or server
130) may be more fully understood with reference to Provisional
U.S. Patent Application No. 61/122,315, filed on Dec. 12, 2008 and
U.S. patent application Ser. No. 12/637,452, filed on Dec. 14, 2009
which were also previously incorporated herein by reference.
[0085] The home monitor 120 includes a processor 122, a storage
medium 124, and transmitting/receiving circuitry 126 and is capable
of interrogating the implanted system 110 (and of receiving
sensor-based data in response) when the patient is within a
predetermined distance of the monitor. In some embodiments, this
distance is approximately twenty to thirty feet. The data
interrogation could also be initiated by the patient via an input
into home monitor 120 or a mobile device such as an iPhone.RTM.
smart phone with ability Pocket Coach software. The information
communicated to the home monitor 120 is encrypted and sent via the
internet to a HIPPA compliant server 130. The information is then
accessible directly by the patient 140 or by approved medical
personnel serving as the patient's health coaches (optionally via a
workstation 160) via a secure web site or other portal 150. While
the home monitor will often comprise a desktop computer or other
desktop unit powered by a wall plug, alternative systems may employ
home monitors with smaller form factors (the home monitor
optionally comprising and/or being similar in size to a notebook
computer, a smart phone, a personal digital assistant, or the like)
powered by batteries or other portable power sources. Where
wireless phone capability is not available to a patient (such as
for a patient visiting or living in a rural area) the home
monitoring system could also comprise a hand held computer and a
port that is connected to the internet via a land-based
telecommunications link such as via a modem and telephone
connection. The implanted device could be interrogated through
radiofrequency (RF) communication with the handheld computer. Such
a handheld computer could also be used to enter journal
information. Placing the hand-held computer in the port would allow
uploading of retrieved device data, and journal entries to the
internet portal. Some or all of the functionality of the home
monitor 120 may instead be implemented using a portable device 170
such as a smart phone, personal digital assistant, or the like.
Even when a home monitor 120 is included in the system, such
portable devices will allow the patient to benefit from
communications to and/or from server 130 when the patient is out of
the house.
[0086] The server 130 contains a number of algorithms designed to
evaluate the implanted device data logs in comparison with goals
established by the patient and his or her health coaches 160. Based
upon the results of the analysis, such as whether the goals have
been met, coaching messages may be sent to the patient, for example
via email, text message or telephone call. The messages are
designed to provide encouragement for positive results and positive
reminders for negative or neutral results. This coaching feature
encourages patients to obtain energy balance in their lives.
Specific examples regarding energy expenditure include sending
encouraging messages for meeting daily or weekly activity goals or
sending patient alerts if extended periods of sedentary activity
have occurred. With regard to caloric intake, examples include
communicating feedback to the patient as to whether eating patterns
show adherence to the eating plan or whether caloric intake is
meeting daily, weekly, or monthly goals.
[0087] Information in the data logs from the activity and
consumption sensors of the implanted device 110 will also allow
cross-checking between the patient's activity and meal diary and
device-detected events. If the diaried and the detected events do
not match (such as when the sensed data indicates that food was
ingested but a snack or meal was not logged in the diary, or when a
meal time or food intake quantity exceeds a logged meal), then
reminders may be sent to the patient to enter additional
information in the diaries, and/or to a health coach to check in
with the patient. Diary entries may be made by a patient via
multiple devices (for example, using a home computer when at home,
a notebook computer when at the office or traveling, and/or a Smart
Phone while at a restaurant, or the like) and in a variety of
different formats (including options for text diary entries, voice
entries, photo entries taken via a digital camera or telephone, and
the like). Although diaries for the purpose of calorie counting
have been typically inaccurate due to lack of patient compliance or
attention, this feedback system facilitates improved accuracy. In
addition, alerts can be set that send performance summary reports
to the patient's health coach and/or physician, which allows the
health coach or physician to intervene when needed. The
intervention could be in the form of extra coaching for the
patient, revising of a weight loss/exercise plan, reprogramming of
the implanted device stimulation parameters, or the like.
[0088] In embodiments of the present invention, the patient may be
provided with a hand-held or pocket device capable of receiving
reminders and other notices from the server 130, or the reminders
may be sent to a general purpose hand-held or pocket device such as
a cell phone or e-mailer, optionally using an appropriate local
user interface or other software resident on that device. A patient
identification and/or password may optionally be entered to the
portable device to obtain patient data so as to prevent others from
accessing sensor-based data. The notices transmitted to the
portable device may include daily inspirational messages; diet and
exercise education information; and particularly feedback messages
(for example, identifying positive and negative events, reached
daily goals, missed goals, skipped meals, excessive meal quantities
or times, and/or added meals or snacks). The feedback messages may
be generated by algorithms contained on the server 130; and/or
cross-checking between device data logs and patient reporting. In
some embodiments of the invention, patients may be offered the
option to join an online support group of patients with similar
body mass indexes (BMI) who have similar attributes and weight loss
goals. This group may meet online using the website 150 to provide
support for one another, as well as review each other's results and
provide support and encouragement to each other via email or text
messaging via their patient-associated portable devices. Hence, the
patients may optionally share access to their sensor-based data
with one or more other appropriate patients so as to allow the
other patients to act as health coaches to the patient in which
device 110 was implanted, and/or so as to allow the implant patient
to coach those other patients based on their associated
sensor-based data. The patient will also optionally have the
ability to invite health coaches into the online community, with
the patient typically granting and managing a support group of the
patient by granting permission to individuals to whom the patient
is willing to allow access to the patient's sensor-based data. The
supporter or member of the group may be a spouse, a gym coach, a
parent, a friend, or a family member. In some embodiments, the
group may include another patient having an implant providing
sensor-based data. Hence, the group may comprise a mutual support
group.
[0089] The patient and/or health coach may obtain updates by
accessing a web site or other portal 150. The portal will
optionally comprise a secure website into which the patient or
other system user enters a patient identifier and/or password,
allowing patients to log into the site with confidence that the
system is safe and secure. Patients should feel sensitive medical
data is sufficiently protected and that highly sensitive medical
data is not displayed as appropriate given the value of the portal.
Portal 150 may optionally comprise a "support dashboard," includes
a comprehensive set of weight loss tools designed to support the
individual. In addition, the support dashboard may allow access to
the data logged by the implanted device 110 by the patient. The
usefulness of the weight loss tools included in portal 150 may be
enhanced through the ease by which the patient is provided accurate
information on his or her daily activity and consumption. The
sensor-based information may optionally be enhanced by patient
reporting of specific food quantities, food types, caloric intake,
and/or the like. The support dashboard may include features such
as: a calorie database, an online calorie counter, a packaged food
database, meal preparation support (such as custom meal menus
generated for that patient), an activity diary, an exercise guide
and planner, a weight tracking log, a body-mass index calculator,
activity or exercise reports, meal frequency and duration reports,
and/or a message center. Portal 150 may present patient performance
based on predetermined activity and caloric goals, optionally
including daily kilocalories to be burned, daily calories consumed,
and/or a net summary of the patient's energy balance. Portal 150
may also present additional sensor-based data, including sleep or
rest data (such as the number of hours slept, a quantified quality
of sleep or other rest periods, and the like).
[0090] Referring still to FIG. 1, portal 150 may have a food
calculator to look up calories of food types, to input quantities
of their planned or consumed meals, and the like. Food calories can
be input and/or determined in a variety of different ways, with the
site optionally employing a food calculator or linking to a
commercial calorie identifying website such as CalorieKing.com or
the like. Meal logging may optionally include uploading data or
photos to the portal directly or by linking to a meal logging
web-base service such as that which was offered commercially by
myfoodphone.com. Portal 150 may also have commercially available
look-up caloric and/or nutritional data from food suppliers,
including commercial prepackaged customized foods suppliers,
restaurant chains, or the like.
[0091] Portal 150 may facilitate networking with identified friends
using known social networking capabilities, giving users the
ability to email to friends and health care providers and accepting
input from such individuals so as to allow them to make public or
private comments and the like. The members may connect into a live
chat room sponsored by the health care practitioner support group
(if desired). This may allow real time coaching based on individual
own performance on eating, exercise and lifestyle opportunities.
The portal may also support a group or circle of friends to allow
individuals to in chat real time or transmit messages to one
another. Portal 150 may optionally accept predetermined or
customized user data, allowing the user to store desired health
related information on their personal page, and to control the
access of others to that information. This data could include blood
pressure, glucose and other data indicative of the general health
status or goals of the patient. The portal will allow for daily
notes from the individual, this will allow users to note overall
feelings of wellness or questions they might have about eating and
motivations.
[0092] To enhance the efficacy of coaching and overall feedback,
portal 150 may allow for feedback from the network based on the
individual's goals. The site will allow for messaging to the
individuals own page (as well as other portable or connected
device, as described above) which the user chooses. This messaging
may be configured to prompt the individual based on performance
achieved or notes about missed activity events, meal events, etc.
The portal may also notify users when a member of their selected
member friends has achieved their personal goals and/or
accomplishments. Portal 150 may also include goal-setting and
behavior/goal comparison tools. Simple goal setting fields may
optionally be available for the patient, though more sophisticated
systems may allow the patient to enter a long-term goal and may
interactively help the patient to determine short term and long
term intermediary goals so as to reach their ultimate weight
reduction target. The system may, for example, provide an
indication of the quantity of exercise that would be appropriate to
achieve an interim or short term weight loss given the patient's
sensed ingestion behavior. Alternatively, a reduction in ingestion
may be determined based on maintaining the patient's sensed
activity level may be identified by the system. Expected results
from changes in ingestion and activity may be identified by the
system. As significant weight loss may not be measured until a
patient has maintained compliance for a relatively extended period,
more immediate short-term goals may also be identified by the
system, including reduction in a size of the patient (such as a
reduction in dress or pants size, a reduction in waist size, a
reduction in neck, arm, or leg circumference, an increase in
walking endurance or speed (or other quantifiable exercise
parameters), or the like may also be identified). Portal 150 may
allow the patient to revise the short term and long term goals
throughout the course of treatment, and may generate comparisons
between the patients measured and sensed performance with their
goals. The system may also be capable of tracking performance
against team goals, with a team comprising weight-loss patients of
a group. Team goals may be generated by the team, a healthcare
provider of the team, or both. As an example, a physician could
create a team of patients, each patient of the team having an
implanted device. The physician could then work with the team to
set a team's goals. This will allow the spirit of competition to be
added into the mix for changing the behavior of the individual
members of the team.
[0093] Portal 150 may include or be linked to one or more reference
websites. The portal will preferably have a number of selected
reference sites for members to choose from. These sites will allow
users to select from a number of tools which the users may
prioritize or the site may keep a current list of most frequently
used sites. This allows users to refer to a particular reference
site based on changing priorities and behaviors. Suitable reference
sites may include information on nutrition (food selection and net
calorie), food preparation, activity guidelines (walking and other
exercises), Kcal Expenditure charts (including activities of daily
living), and/or the like. Portal 150 will allow the user to
communicate their health status to others, such as by providing the
ability to send permission to view the patient's page to an MD,
nutritionists, or a selected friend or group member. The patient's
page on the portal will typically store a history of the patient,
including their weight, wireless or other uploads by or regarding
the patient, and the like. Educational links may facilitate access
to nutritional information, exercise information, stress management
techniques, and lifestyle coaching guides.
[0094] As indicated above, a number of additional devices may
communicate with the components of system 100 shown in FIG. 1.
Along with portable or handheld devices 170 (such as a
BlackBerry.TM. wireless e-mailer, an iPod.TM. or other mobile music
player, an iPhone.TM. or other mobile phone, and the like), home
monitor 120 or server 130 may communicate with scales (for
measuring a weight of the patient or food), pedometers, and the
like. In exemplary embodiments, home monitor 120 receives wireless
telemetry from a scale, glucose monitor, blood pressure cuff,
and/or the like.
[0095] FIG. 1A shows an exemplary gastric band sensor system
implant 900. This embodiment includes a gastric band,
laparoscopically implanted, also known as a lap band 902 having a
fluid-filled cuff 903 coupled to an implanted port 904 via a fluid
conduit 906. The gastric band may comprise any such lap band
currently marketed or available in clinical trials, as for example,
the Realize.RTM. Adjustable Gastric Band from Ethicon Endo-Surgery,
Inc., the Lap-Band.RTM. from Allergan, Inc., the Midband.TM. from
Medical Innovation Development, and Heliogast.RTM. Band from
Helioscopie, MiniMizer Extra from Bariatric Solutions. The
gastrointestinal constriction provided by lap band 902 can be
varied by injecting or removing fluid from port 904 using a
syringe. Along with mechanically constricting gastrointestinal
flow, system 900 includes a housing 920 with circuitry comprising a
processor 922 and a battery 924 to wirelessly transmit signals
generated in response to signals from one or more sensors 928 to a
data collection center. The data collection center comprises the
web portal 150 shown in FIG. 1 or a data server. Note that the
housing 920 may optionally be incorporated into port 904.
[0096] System 900 will sense ingestion using signals from at least
one sensor 926. Sensor 926 comprises at least one of a pressure 928
(e.g. a MEMS-type, strain-gage, etc.), temperature, pH, acoustic,
or optical sensor to detect food or drink intake. Sensor 926 may
also comprise an activity sensor, such as an accelerometer, heart
rate sensor, temperature-based ingestion sensor and/or a core body
temperature sensor. The at least one sensor may be wired to the
housing 920, or communicate wirelessly with the processor in the
housing.
[0097] FIG. 1B illustrates the electrical stimulation component of
the gastric band sensor system implant 900. The stimulator 20
comprises a housing 21 implanted subcutaneously within a patient.
The stimulator further comprises leads 22a, 23a extending from the
housing 21 through the abdomen and to the stomach 100 where
electrodes 22, 23 at the end of the leads 22a, 23a are implanted
into the stomach muscle layer from the outside of the stomach 100.
A method of implanting the stimulator housing 21 and
laparoscopically implanting the electrodes 22, 23 in the stomach
100 is generally known to those of ordinary skill in the art.
[0098] The housing 21 further comprises a sensor 24a located on the
housing 21 and/or a sensor 24b located elsewhere in the patient and
coupled to the electronic circuitry 29, (FIG. 1B) in the housing 21
by lead 24c. The sensor 24a or 24b may, for example, include an
accelerometer that is configured to sense motion of the patient.
The stimulator also includes sensors 25, 26, that are implanted on
and in the stomach 100, respectively, with leads 25a, 26a extending
from the sensors 25, 26 to the housing 21. Sensor 26 is exposed to
the inside of the stomach 100 while sensor 25 is attached to the
outside of the stomach. Leads 22a, 23a and 24c, 25a, 26a are
electrically coupled to the electronic circuitry 29 located in the
housing 21. When the sensors 25, 26 are implanted in the stomach,
they may sense presence of material in the stomach, composition of
such material and temperature, pH or pressure within the stomach,
and/or patient motion corresponding to respiration or gross
movement. Sensors positioned on the stomach may also sense various
parameters that indicate the actions of the stomach, e.g.,
movement, contractions. The sensors positioned on the stomach may
also utilize various imaging techniques, e.g., ultrasound, and
light, to identify presence or composition of food or material in
the stomach.
[0099] In use, once the stimulator 20 is deployed, electrical
stimulation is provided through electronic circuitry 29. The
electronic circuitry 29 is capable of producing various types of
programmable waveforms that provide stimulation to the smooth
muscle lining of the intestinal tract. It is well known to those of
ordinary skill in the art, there are many different types of
electrical stimulation programs and strategies which can be
utilized for providing electrical stimulation parameters through
the circuitry 29, the principal focus being providing electrically
stimulating parameters for the stomach. In one embodiment the focus
of the electrical stimulation is to cause gastric retention of food
to produce a sensation of satiety. Another focus of the electrical
stimulation may be to interfere with the innate peristalsis of the
stomach, which is intended herein to mean to movement of the
stomach that typically also acts to break down food and/or moves
material towards the antrum or out of the stomach. Another focus is
to cause a sensation of satiety by stimulating the stomach. Another
focus is to control the secretions relating to the stomach or
hunger by stimulating the stomach.
[0100] An embodiment of the electronic circuitry 29 is illustrated
in FIG. 1C. The electronic circuitry 29 of the stimulator is
located in the housing 21. The electronic circuitry 29 may be in a
form of a standardized chip that may be used with one or a variety
of sensors, including but not limited to those described herein.
The electronic circuitry 29 or similar electronic circuitry may
also be included with separately implanted sensors or components of
the system. Thus the various components may be configured to
communicate with the other components through telemetry or similar
signaling.
[0101] The circuitry 29 comprises, a microprocessor or controller
40 for controlling the operations of the electronic circuitry 29,
an internal clock 41, and battery device 44 such as a pair of
lithium iodine batteries for powering the various components of the
circuit 29. As such, the controller 40 and battery device 44 are
coupled to each of the major components of the circuit as would be
apparent to one of ordinary skill in the art. The battery 44 has
its output supplied to a DC-to-DC converter 44a to provide a higher
voltage, which is utilized for electrical stimulation pulses. The
DC-to-DC converter 44a is conventional and provides an output
voltage desired for stimulation. The internal clock 41 may also
include a real time clock component that communicates with the
controller/microprocessor 40. The real time clock component may be
used to control stimulation, e.g. by stimulating or allowing
stimulation only at a particular time of the day. The real time
clock component may also provide a date/time stamp for detected
events that are stored as information in a memory device. The
memory may be preserved by only saving information corresponding to
an event of interest which is saved along with the time/date when
the event occurred.
[0102] The controller 40 is coupled to stimulation driver 42, which
is coupled to stimulating electrodes (e.g., 22, 23) that are used
to provide electrical stimulation in accordance with programmed
parameters, including in response to sensing conditions relating to
the patient or the patient's intake of food as described
herein.
[0103] The controller 40 is coupled to ROM 43, which contains the
program instructions for the controller 40 and any other
permanently stored information that allows the
microprocessor/controller 40 to operate. The controller 40
addresses memory in ROM 43 through address bus 43a and the ROM 43
provides the stored program instruction to the controller 40 via
data bus 43b. The controller/processor 40 controls the telemetry
coil 45, which communicates with an external control or programming
device 60 (FIG. 1D), e.g., via a modulated RF signal.
Controller/processor 40 is coupled to a buffered oscillator 51 that
provides an RF signal to be emitted from the telemetry coil 45. The
RF signal is preferably at about 100 kHz-5 Mhz so that the signal
is efficiently transmitted through tissue. The controller 40
controls the oscillator 51 and provides data to be modulated with
the RF signal. For example, various sensed data such as motion,
transmitted or reflected light parameters, pressure, pH,
temperature, local muscle contraction, strain, impedance,
electrical activity (EMG) etc., may be delivered via a modulated
signal through the telemetry coil 45. When the telemetry coil 45 is
receiving an external telemetry signal, the buffered oscillator 51
is disabled. Telemetry signals received on the telemetry coil 45
are detected in a detector circuit 51 a and communicated to
controller 40. The detector circuit may be selected based on the
modulation used for the telemetry signals.
[0104] The circuit 29 may also be coupled through A/D converters
(with amplifiers) 46a, 46b, 46c, 46d to one or more sensors 25, 26,
24a, 24 respectively. The A/D converters convert a representative
analog electrical signal from the sensors into a digital signal
communicated to the controller 40. Suitable types of these sensors
may include but are not limited to the types of sensor described
herein. Such sensors at various locations are coupled to the
electronic circuit by way of lead wires or through alternative
means of communication such as telemetry, wireless communication or
indirectly through a separate controller e.g., controller 70 shown
in FIG. 1D.
[0105] Controller 40 is coupled to RAM 50 via an address bus 50a
for addressing a location in RAM 50 and a bi-directional data bus
50b for delivering information to and from RAM memory 50. The RAM
memory 50 includes event memory 48 that temporarily stores data
recorded by sensors 24a, 24, 25, 26, or electrodes 22 23. RAM
memory 50 also includes a programmable memory 49 which may be
programmed, for example, by an external programmer 60. The data
stored in the programmable memory may include specifications for
the electrical stimulation operating modes (e.g., waveform, type of
stimulations: for pacing, inducing, interfering with or reversing
contraction, for interfering with innate activity, for controlling
biochemistry or secretions relating to the stomach, or other types
of stimulation) and various procedures or responsive parameters
(e.g., for turning on or off various sensing or stimulation
functions, parameter modification, protocols or procedures for
recognizing various conditions of the patient of the patient's
gastrointestinal tract and protocols or procedures for responding
to such recognition). These data and procedure/protocol elements,
including responsive elements that respond to sensed data, may also
be located in whole or in part in other controller devices that may
be located independently from electronic circuitry 29. The
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 the sensors
or electrodes, provided to the controller 40 may be stored in event
memory 48 in the RAM 50. The data stored in the event memory 48 may
be sent intermittently as data bursts via the telemetry coil 45, as
opposed to continuously, in order to save battery power. The clock
may also mark or date/time stamp the data stored in event memory.
The processor also may select events based on predetermined
thresholds or characteristics that are to be stored as a
significant event, while other events are filtered out and not
stored.
[0106] The electrodes 22, 23 are coupled through A/D converters 46e
and 46f to the microprocessor 40. A/D converter 46e converts the
electrical EMG signal sensed by the electrodes 22, 23 into a
digital signal representative of the EMG electrical activity, which
is delivered to the microprocessor/controller 40 and stored in the
event memory 48 in the RAM 50. Also, the A/D converter 46f converts
the electrical signal sensed by the electrodes 22, 23 and provided
through the impedance circuit 53 described below, into a digital
signal representative of tissue impedance, which is delivered to
the microprocessor and stored in the event memory 48 in the RAM
50.
[0107] The electrode 22, 23 outputs are used to provide electrical
stimulation delivered through the stimulation driver 42 to
electrodes. The stimulation modes and parameters can either be set
using the external programmer 60, or they may be set in response to
sensory feedback. The same electrode outputs may be used to sense
impedance of the stomach tissue or of the contents of the stomach
depending upon the location of the electrodes. Impedance circuit 53
is used to sense impedance and EMG or other electrical activity
information is provided to the processor 40 through A/D converter
46e. The electrodes 22, 23 are coupled through coupling capacitors
55a and 55b respectively, to output of electrical stimulation
driver 42 and input of A/D converters 46e, 46f.
[0108] The impedance circuit 53 comprises a constant current source
oscillator 54 that oscillates at a frequency of 50-100 kHz, and A/D
converter 46f with an output coupled to the controller 40. The
oscillator 54 provides a constant current source through electrodes
22, 23 resulting in a voltage across the electrodes 22, 23 that is
representative of impedance, in view of the constant current. The
voltage is provided through and is converted by A/D converter 46f
to a digital signal representative of impedance. A/D converter 46f
has a bandwidth that includes the 50 kHz frequency signal while
filtering out the electrical stimulation signal that is delivered
to the electrodes 22, 23 through electrical stimulation driver 42,
and the EMG signal that is sensed by the electrodes 22, 23. Both of
the outputs are filtered out by A/D converter 46f A/D converter 46e
has a bandwidth that filters out the 50-100 kHz signal. Further,
when a stimulation signal is being delivered, the controller 40
does not receive signals from A/D converters 46e and 46f Thus the
EMG and impedance sensing functions and the stimulation deliver
functions may be separated through the electronic circuitry 29,
though using the same electrodes.
[0109] An additional circuit 58 may be provided in the electronic
circuitry 29 comprised of similar components configured like
impedance circuit 53. The circuit 58 delivers an interrogating
electrical pulse to the electrodes 16, 17 and senses impedance of
material between the electrodes. The electrodes 16, 17 are
positioned to be in electrical contact with contents of materials
that may be in the stomach
[0110] Additional stimulating sensing electrodes and corresponding
signal processing circuits may also be provided.
[0111] FIG. 1C illustrates the electronic circuitry 63 for external
programmer 60. The electronic circuitry 63 comprises: a
microprocessor or controller 70 for controlling the operations of
the electronic circuitry, an internal clock 71, and a power source
74 such as battery device for powering the various components of
the circuit 63. As such, the controller 70 and battery device 74
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 70
is coupled to a speaker 67 that provides audible alerts and a
display 66 such as a CRT to display data such as recorded data,
sensed parameters, treatment parameters and status of device (e.g.
position or battery charge status). The controller 70 is coupled
through a buffer 64 to external input device 65 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 66 or
speaker 67, or to turn device on and off The external programmer 60
is also provided with an external data port 68 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 70. 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.
[0112] The controller 70 is coupled to ROM 73, which contains the
program instructions for the controller 70 and any other
permanently stored information that allows the
microprocessor/controller to operate. The controller 70 addresses
memory in ROM 73 through address bus 73a and the ROM 73 provides
the stored program instruction to the controller 70 via data bus
73b.
[0113] The transceiver comprises a telemetry coil 74, an oscillator
72 and an A/D converter 76. The controller 70 controls the
telemetry coil 75, which communicates with stimulator electronics
29 (FIG. 1B) through its telemetry coil 45. Controller 70 is
coupled to an oscillator 72 that provides an RF signal, preferably
having a characteristic frequency of 500 kHz or higher, to be
emitted from the telemetry coil 75. The controller 70 controls the
oscillator 72 and provides data to be modulated with the RF signal,
for example, programming information, stimulation parameters, etc.
The telemetry coil 75 also receives information transmitted via RF
signal from telemetry coil 45 on the stimulator 10 such as various
sensed data, e.g., temperature, pressure, pH, impedance of the
stomach or of its contents, optical characteristics of stomach
contents, motion data, electrical activity (EMG), etc. The received
RF signal is passed through A/D converter 76 and is transmitted to
the controller 70.
[0114] The data is delivered to the event memory 78 in RAM 77 by
way of data bus 77b for temporary storage. The data may be
retrieved from RAM 77 by addressing the storage location via the
address bus 77a.
[0115] Event memory 78 temporarily stores data sensed by sensors
24a, 24, 25, 26, or electrodes 22, 23; recorded through controller
40; and delivered via telemetry to the external programmer 60. The
data may then be downloaded onto a computer using the external data
port 68. The RAM 77 also includes a programmable memory 79 which
may be programmed, for example, to specify operating modes such as
waveform, frequency, pulse width, amplitude, repetition rate, etc.
which programming is then telemetrically communicated to the
stimulation device 20. The modes and parameters can either be set
using an external programmer 60 and/or set in response to sensory
feedback according to programs.
[0116] The stimulator 20 may be programmed to deliver electrical
stimulation in response to sensed parameters. The sensors 24a, 24,
25, 26, or electrodes 22, 23, depending upon their specific
location, may comprise (but are not limited to): a temperature
sensor that may sense a change in temperature or a rate of change
in temperature that indicates ingestion of food or liquid; a pH
sensor that may be used to determine when food has been ingested;
an optical emitter/sensor that may be used to determine the
presence and/or composition of food; a pressure sensors that may be
used to sense motility patterns, e.g. presence, strength or
frequency of contractions; a contractions sensor that may provide
information on stomach contractions and local responses to
stimulation; an impedance sensor that may provide information on
the content of the stomach and/or an impedance sensor that may
determine when a characteristic EMG pattern exists to determine
wakefulness of a subject; a motion sensor that determines an
activity level or wakefulness of a subject; a biochemical sensor
that provide information on biochemical compositions relating to
the stomach such as secretions.
[0117] The responsive devices may comprise at least one sensor and
at least one responsive element. From sensed information, the
responsive element determines the existence of a condition, e.g.,
presence of food; ingestion of food; type of food ingested;
activity level of a subject; wakefulness of a subject; time of a
daily cycle or schedule; contractions of the stomach, etc.
[0118] The responsive element may combine a number of sensed
parameters to determine the existence of a condition or
circumstance or a probability of the existence of a condition or
circumstance. The responsive element may thereupon determine a
course of treatment, including protocols, stimulation parameters
and whether or not to stimulate. In one variation responsive
element may respond by stimulating to interfere with the stomach
contractions; to slow, stop or reverse the innate peristaltic
contractions that tend to move food through the stomach.
[0119] For example, the combined determination of temperature
changes indicating likelihood of food ingestion, and an
accelerometer indicating that a subject is not sleeping or is not
highly active may trigger a responsive element to stimulate the
stomach to retain food for a predetermined period of time. The
accelerometer can determine a low level of activity indicating
likelihood of a sleep state, but may be overridden by a temperature
sensor sensing that food has been ingested and thus requiring
stimulation. PH may be used in a similar manner as temperature to
indicate a likelihood of food ingestion. A timer may also confirm
the likelihood that food is being eaten given the time of day, or
may refrain from stimulating in spite of food being ingested if it
is a certain time of day, e.g., when the stomach is naturally
cleaning out the stomach as it typically does during the night.
[0120] The responsive element may receive input from one or more
sensors and, in response, the responsive element may interrogate
another sensor for information to determine a course of action.
This may be used to save battery or power consumption. This may
also be used to confirm the existence of a condition or
circumstance using more than one sensor. For example, one or more
sensors may provide information that food has been ingested. Upon
making this determination, another sensor may be triggered to
determine what type of food has been ingested. For example, an
impedance sensor may determine characteristics of the content of
the stomach by measuring the impedance of the contents of the
stomach. An optical emitter/sensor may sense the light
reflectance/transmission characteristics of contents of the
stomach. This information may be recorded in a memory device and
downloaded. Also the information may elicit a simulation response
controlled by the responsive element when a certain type of food is
detected. In addition foods may be provided as part of an eating
regimen that have markers for different types of food. Gastric
retention of some foods may be created while permitting movement of
others out of the stomach.
[0121] As shown in FIG. 1A, the sensor 928 may be mounted in fluid
communication with port 904. FIGS. 2A-2C illustrate alternative
embodiments of system 900. FIG. 2A shows sensor 928 coupled to the
fluid-filled cuff 903, the housing 920, circuitry 922, and battery
924 are also attached to the lap band 902. FIG. 2B shows sensor 928
coupled to the fluid filled cuff 903, while housing 920, circuitry
922 and battery 924 are located outside the lap band 902,
optionally attached to the implanted port 904.
[0122] FIG. 2C shows an embodiment of system 900 comprising at
least two sensors 926. Pressure sensor 928 may be coupled to the
fluid-filled cuff 903. The second sensor 926 may comprise a
temperature sensor 927 penetrating the stomach wall, coupled to the
housing 920 or to the fluid filled cuff 903 and pressure sensor 928
(not shown). This embodiment is particularly suitable when the
sensor 928 must collect data from inside the stomach. In an
alternative embodiment the second sensor 926 may comprise a sensor
attached to the outside of the stomach 925, coupled to the housing
920 or to the fluid filled cuff 903 and pressure sensor 928 (not
shown). In yet another alternative embodiment, system 900 comprises
a combination of at least three sensors 928, 927, and 925, as
described above.
[0123] FIG. 2D shows an embodiment of system 900 comprising two
pressure sensors 928 coupled to the fluid-filled cuff 903. One
pressure sensor 928 may located above the fluid filled cuff, to
measure the pressure above the lap band, and the other may be
located below the lap band to measure the pressure in the stomach,
below the level of the lap band.
[0124] FIG. 2E shows an alternative embodiment of system 900
comprising at least two lap bands, each lap band comprising at
least one sensor 926. The lap bands may comprise different
elasticities and each lap band's elasticity may be changed
dynamically. The superiorly-located lap band may be used to reduce
food intake and sense ingestion events with the at least one
sensor. The inferiorly-placed lap band may be used primarily for
sensing purposes with the at least one sensor. Since the
inferiorly-placed lap band may not be inflated, it may need to be
fixed in its desired location with seromuscular sutures such as the
MiniMizer Extra from Bariatric Solutions, or other means known in
the art. If the superiorly-placed band is not fully inflated, it
may also need to be fixated using seromuscular sutures, or other
means known in the art. The dual lap band set-up may also comprise
other sensors, such as for example a combination of optical sensors
that can measure ingestion velocities in the lower esophagus and
upper portion of the stomach.
Food and Drink Intake Detection
[0125] FIG. 3 illustrates ingestion of food or drink into a
stomach. As food intake occurs pressure increases within the lap
band, in the upper portion of the stomach and in the lower
esophagus. The lower esophagus and upper portion or the stomach
will expand to accommodate the incoming food as shown by dashed
lines in FIG. 3. FIG. 3A shows a cross-sectional view of the
superior portion of the stomach constricted by a lap band 902 with
a fluid filled cuff 903. The lap band restricts the perimeter of
the stomach, thus slowing down the passage of the food through the
stomach. Following ingestion, food moves down the esophagus to the
superior portion of the stomach, accumulating above the lap band
placing an increasing amount of pressure on the lap band, as well
as the upper portion of the stomach (gastric pouch), and lower
portion of the esophagus. This accumulation of food and the
accompanying increase in pressure on the lap band will occur up to
a certain point, then peristaltic action will push the food through
the band, thereby causing a drop in pressure.
[0126] FIGS. 4A-4C show the pressure waveforms from pressure sensor
signals one might expect with food or drink input. FIG. 4A shows
the expected pressure waveforms from an ingestion of food 1000.
With each swallow of solid food the pressure on the band increases
(1020). As the food fills up the gastric pouch, the lower esophagus
peristaltic waves are initiated in the esophagus and stomach to
push food through the narrow opening created by the band. If the
food is solid and dry, the digestion and peristaltic action on the
food will not be enough to push the food out as fast it is entering
the stomach. At this point the patient will feel severe discomfort
and be forced to stop eating, or a vomiting reflex may occur, and
maximum pressure is seen at the band (1000). After a delay, the
peristaltic waves eventually empty the gastric pouch and baseline
pressure will be again detected at the band (1040).
[0127] FIG. 4B illustrates an overeating event; as food is ingested
the pressure increases moderately 1060 until a plateau is reached
1070. However, when overeating occurs, the increased food intake
beyond the volume of a normal ingestion event increases the
pressure at the band and proximal portion of the stomach to a much
higher level 1080. This high pressure sets off the vomiting reflex
1090; after vomiting and the pressure rapidly decreases 1100 with
the emptying of the proximal portion of the stomach.
[0128] FIG. 4C shows the expected pressure waveforms 1200 from a
drinking event. Compared to the expected pressure wave forms from
ingestion of a solid, upon ingestion of a drink 1210, there will be
less buildup of pressure because liquid passes through the band
with little resistance. However, there will be transient pressure
increases 1220 with each swallow of liquid, as the increase in
volume will temporarily expand the small upper portion of the
stomach. Furthermore, since the liquid can exit the proximal
portion of the stomach rapidly, it is unlikely that drink intake
will be so fast as to cause the pressure to increase to such an
extent that a vomiting reflex would occur.
[0129] The differences in pressure waveforms between a normal
eating event and a drinking event can be distinguished by the
processor. Drinking events will look like multiple positive
pressure transients with a return to baseline pressure very quickly
after each transient (nominally less than 30 sec). While an intake
of any significant volume of solid food (>20 ml) will lead to an
increase in pressure that lasts multiple minutes (5-30 min). In
addition because of the pressure put on the gastric pouch and lower
esophagus during the intake of solid foods, peristaltic waves will
cause large pressure transients at the band, on the order of 10's
of mm Hg. An increased pressure that lasts at least 5 minutes, but
not more than 60 minutes will very likely be interpreted as an
ingestion of a solid; whereas, an increased pressure that lasts at
on the order of 10 sec to 2 minutes will very likely be interpreted
as an ingestion of a liquid. These results of the food intake
diagnostics can be provided to the patient or physician in order to
show compliance or lack of compliance with dietary
instructions.
[0130] FIG. 5 shows the pressure waveforms 1300 that occur with
injection of fluid, e.g. saline, into the port of the lap band. The
baseline pressure 1210 increases as fluid is injected into the
port. The increase in fluid (saline) volume expands the elastic
portion of the port so that it creates a smaller diameter for food
to pass through, which leads to an increase in pressure 1320 upon
ingestion of food. The pressure changes caused by eating events
with eating events 1320 or drinking events 1330 will manifest
themselves on top of the baseline pressure. However, this baseline
pressure change may be transient as the volume of the lap band may
adjust to accommodate the saline. The occurrence of pressure
transients due to peristaltic waves following drink intake, may
indicate that the band is too tight. These peristaltic waves may be
detected at the band and lead to automated adjustment of the band
to reduce pressure.
[0131] FIG. 6 shows pressure waveforms from peristaltic waves 1400.
Slow waves or peristaltic action in the stomach that is always
present, is seen as low amplitude pressure waves at a frequency of
about 3 per minute 1410. After food intake occurs, the baseline
pressure increases and pressure transients due to swallowing and
peristaltic action are seen riding on the baseline change. As food
intake continues, the pressure at the band and gastric pouch
increases and the pressure transients due to peristalsis increase
in amplitude and frequency. As the bolus moves forward, the
pressure decreases behind it. FIG. 6 shows the initial small
transient pressure increases due to peristaltic activity. The
peristaltic waves that occur without the presence of food cause
little or no pressure change. However, beginning at the cephalic
phase, and when food or liquid enters the stomach the peristaltic
waves would cause pressure waves of amplitude and duration that is
proportional to the amplitude and duration of the peristaltic wave
1430. The peristaltic activity at the end of the meal is higher in
order to push the food out of the stomach towards the small
intestine, pressure undulations 1440 caused by these peristaltic
waves will occur as the pressure recovers to the former
baseline.
[0132] Pressure waves due to peristaltic activity need to be
differentiated from pressure waves due to food intake. In the case
of a pressure sensor on the lap band these pressure waves can be
differentiated because of their higher frequency and the amplitude
of the pressure transients is significantly higher than the overall
increased pressure waves due to food intake.
[0133] Optionally, temperature, optical, impedance, pH, or acoustic
sensors signals may also contribute data to be used in food and
drink intake detection. In one embodiment, temperature sensors can
detect rapid changes in homeostatic temperature within the stomach
cavity. The rapid changes in homeostatic temperature can be used to
detect ingestion events, and in particular, ingestions of liquids.
In another embodiment, impedance spectrometers could determine
water content, acidity or other through the measure of impedance of
materials; optical spectrometers may determine the composition of
ingested matter (i.e. sugar, carbohydrate, and fat content); pH
sensors may determine the ingestion of water and other food through
changes in acidity from baseline, and acoustic sensors may detect
sound waves as each swallow occurs, and as a food bolus passes
through the lap band, etc.
Remote Communication:
[0134] Remote communication with the system 900 will allow the use
of an automated patient support system that would allow coaching
type feedback with regards to their activity and food intake, U.S.
Patent Application Ser. No. 61/166,636.
[0135] In some embodiments, an electrical conduit extends from a
temperature sensor within the stomach, through a transgastric port,
and to circuitry 922. This electrical conduit or lead could, but
need not have any stimulating electrodes. Suitable trans-gastric
temperature sensing probes and ingestion analysis may described in
(or may be modified from those described in) U.S. Provisional
Patent Application No. 61/122,315, filed on Dec. 12, 2008, the full
disclosure of which is incorporated herein by reference, and U.S.
patent application Ser. No. 12/637,452 filed on Dec. 14, 2009.
Food or Drink Classification:
[0136] The pressure waveforms from food 1000 and drink ingestion
1200 can provide input to a food and drink selection algorithm. The
detection may be based on slope, maximum deviation from baseline,
or other signal characteristics of the pressure waveform regarding
event classification. When food intake occurs, diagnostics are
stored based on the timing and duration of the intake. The
diagnostics may be used in monitoring patient's weight loss
therapy.
[0137] As shown in FIG. 2D and 2E, pressure sensors may collect
pressure readings above and below the restriction created by the
inflated lap band. The two pressure readings may be used to
classify the ingestion event: for example if the pressure reading
above the restriction is higher than the one below, the ingestion
will be classified as a solid; if the pressure reading above the
restriction is lower than the one below, the ingestion will be
classified as a liquid or an attempt to cheat the lap band by
blending solid food with a liquid to bypass the restriction of the
lap band.
[0138] As shown in FIG. 9, signals from a combination of pressure
sensor and a temperature sensor may be used to improve the accuracy
of the food detection algorithm. Thus, a high temperature change
combined with a low pressure change over a certain time interval
will lead to a classification of the ingestion event as a liquid. A
low temperature change, combined with a high pressure change will
lead to a classification of the ingestion event as a solid. A high
temperature change, combined with a high pressure change, will lead
to a classification of the ingestion event as a combined solid and
liquid.
Caloric Determination:
[0139] The detection of these peristaltic waves by the pressure
sensor in the lap band sensor system may aid in the determination
of caloric or fat content of a meal. Fat and protein chemodetectors
in the small intestine provide feedback information through a vagal
pathway that controls the amplitude and duration of the peristaltic
activity in the stomach and increases the duration of time the food
spends in the stomach. The main contractions occur in the antral
portion of the stomach, so they may be detected easier with an
intragastric balloon, but as the stomach empties the strong
peristaltic activity rises higher towards the body of the stomach
and these changes could be sensed by a pressure sensor located in
the lap band.
Lap Band Adjustment:
[0140] Individual ingestion events or ingestion patterns will
trigger various therapeutic approaches. In alternative embodiments,
the food and drink intake data may be used to trigger automatic
tightening of the lap band upon detection of an ingestion
event.
[0141] In other embodiments, the implanted device may be capable of
electrical stimulation for therapy delivery to an appropriate
portion of the stomach wall. For example, electrodes may be placed
inside the lap band, to provide electrical stimulation to the
portion of the stomach in contact with the lap band. In this case,
the pressure waveforms will trigger therapy, with the therapy type
dependent on the classification of event.
[0142] In another embodiment, the lap band may be only partially
inflated, to minimize the side effects such as nausea and vomiting;
the partial inflation of the lap band will physically restrict the
food intake to a certain extent, while the electrical stimulation
to further curb the patient's appetite. A patient will be able to
achieve substantial weight loss with minimal side effects.
[0143] In one embodiment the lap band sensor system is capable of
automatically adjusting the lap band. The pressure signal could be
used to automatically determine when a band adjustment is needed.
The adjustment may be based on the baseline pressure level, so that
the band could be adjusted to stay at a target level. In a further
embodiment, the lap band sensor system may comprise an algorithm to
relieve pressure on the lap band for certain periods during the
day, between meals and/or at night, to avoid erosion and pressure
damage to the stomach tissue under the band. The pressure signal
may be useful for detecting pre-vomiting and optimizing lap band
adjustment.
Activity Sensors:
[0144] System 900 would optionally include a 3D accelerometer
and/or a heart rate sensor. This sensor would provide feedback to
the patients as to whether they are meeting their activity and
exercise goals. Further, these sensors would provide estimates as
to the number of calories burned in during exercise and/or total
daily energy expenditure, as disclosed in U.S. Provisional Patent
Application No. 61/241,154 which is hereby incorporated by
reference. The activity sensor(s) may allow therapy adjustment,
such as loosening of the gastric band and lessening the intensity
or stopping electrical stimulation, during exercise sessions and
for a short period, up to thirty minutes after exercising, to
encourage healthy eating patterns.
[0145] The accelerometer data may also reduce the tightness of the
lap band when sleep is detected. This may reduce the side effects
that have been associated with lap banding, such as acid
reflux.
Intragastric Balloon Sensor System:
[0146] An alternative embodiment includes a intragastric balloon
system 1500 having sensors and telemetry circuitry suitable for
implantation in the stomach cavity, endoscopically deployed
stimulation systems having sensors and telemetry circuitry suitable
for implantation in the stomach cavity, and the like. The
intragastric balloon may comprise any such balloon currently
marketed or available in clinical trials, as for example, the
BioEnterics.RTM. Intragastric Balloon (BIB.RTM.) System of the dual
intragastric balloon developed by ReShape Medical.TM. Inc.
[0147] FIG. 7 shows an exemplary intragastric
balloon-sensor-monitor system 1500. The sensor-monitor device 1520
may be used in conjunction with an intragastric balloon 1510. In
this case the sensor-monitor device 1520 could be inserted within
the balloon so that when the balloon is filled with saline inside
the stomach, the device would be enclosed within the balloon. The
sensor-monitor device will comprise a sensor 1530; the sensor may
comprise a pressure sensor that would pick up pressure changes
within the balloon.
[0148] Pressure changes that occur outside the walls of the balloon
will change the internal pressure of the balloon since the material
of the balloon is compliant. In an alternative embodiment, the
intragastric balloon-sensor-monitoring system 1500 comprises a
monitoring device placed outside the balloon, where a pressure
sensor 1520 is attached to the surface of the monitoring
device.
[0149] Other sensors, such as pressure sensors (e.g. a MEMS-type,
strain-gage, etc.), temperature, pH, acoustic, optical sensor to
detect food or drink intake and/or activity sensor, such as an
accelerometer, heart rate sensor, and/or a core body temperature
sensor. The at least one sensor may be wired to the sensor-monitor
device 1520, or communicate wirelessly with the processor in the
housing.
Sensors Used with Other Type of Stomach Reduction/Bypass
Surgeries:
[0150] In the case of gastric bypass and stomach reduction
surgeries, the monitoring device could be implanted at the time of
surgery, potentially at one of the incisions used as a port for the
laparoscopic tools.
[0151] The sensors and monitoring device may also be used in
conjunction with a cardiac device or insulin pump who have cardiac
problems or diabetes as a co-morbidity with obesity.
Method of Treatment:
[0152] FIG. 8 shows a method of treating a patient with an
unhealthy ingestion pattern 2000. A therapeutic implant comprising
a gastric band sensor system or an intragastric balloon sensor
system 2010 is implanted into a patient. The sensor(s) in the
system will sense ingestion by the patient and generate signals
correlating to the ingestion 2020. Ingestion deemed unhealthy will
be inhibited 2030. For example, patients are given behavioral
guidelines to maximize solid food ingestion, and not to drink high
calorie liquids or purees. If the device detects a high proportion
of liquid intake, then actions will be taken to inhibit the next
liquid intake. Another example of unhealthy ingestion would be when
the patient has consumed too many calories over a certain period of
time based on food content detection.
[0153] In some cases, as shown in FIG. 8A, a therapeutic implant
comprising a gastric band sensor system or an intragastric balloon
sensor system 2010 is implanted into a patient. The sensor(s) in
the system will sense ingestion by the patient and generate signals
correlating to the ingestion 2020. Ingestion deemed unhealthy will
be inhibited 2040 by either showing a display to a lifestyle coach
and/or patient 2050, an increased pressure within the bladder of
the lap band or within the intragastric balloon 2060, or electrical
stimulation of the gastrointestinal tract tissue with the implant
2070.
[0154] In some cases, as shown by FIG. 8B, a therapeutic implant
comprising a gastric band sensor system or an intragastric balloon
sensor system 2010 is implanted into a patient. The sensor(s) in
the system will sense ingestion by the patient 2080 and signals
will be transmitted in response to the sensing 2090, and ingestion
information will be displayed to the patient 2100 and/or the
patient will be treated 2110.
[0155] In some cases, as shown by FIG. 8C, a therapeutic implant
comprising a gastric band sensor system or an intragastric balloon
sensor system 2010 is implanted into a patient. The sensor(s) in
the system will sense physical activity by the patient 2120 and
signals will be transmitted in response to the sensing 2130, and
physical activity information will be displayed to the patient 2140
and/or the patient will be treated 2150. In an alternative
embodiment, the patient will receive both ingestion and activity
information, in terms of energy balance; thus the patient will be
able to easily visualize whether the calorie intake has been larger
than the calorie output, or vice versa.
[0156] In some cases, as shown in FIG. 8D, a therapeutic implant
comprising a gastric band sensor system or an intragastric balloon
sensor system 2010 is implanted into a patient. Upon identification
of unhealthy ingestion 2160, signals will be transmitted to the
patient to stop the unhealthy ingestion 2170.
[0157] FIG. 8E shows another alternative treatment method where a
therapeutic implant comprising a gastric band sensor system or an
intragastric balloon sensor system 2010 is implanted into a
patient. Allowed ingestions are identified 2180 and the ingested
material is allowed to pass through the implant system 2190.
Unhealthy ingestions are identified 2200 and signals are
transmitted to the implant to restrict unhealthy ingestion
2210.
[0158] While exemplary embodiments have been described in some
detail for clarity of understanding and by way of example, a
variety of adaptations, modifications, and changes will be obvious
to those of skill in the art. Hence, the scope of the present
invention is limited solely by the appended claims.
* * * * *
References