U.S. patent application number 17/201716 was filed with the patent office on 2021-07-01 for devices and methods for the treatment of metabolic disorders.
The applicant listed for this patent is Ethicon Endo-Surgery, Inc.. Invention is credited to Toralf Bork, Rocco Crivelli, Jason L. Harris, Mathilde Miguras, Mark S. Ortiz, Martin Pfleiderer, Yanik Tardy.
Application Number | 20210196952 17/201716 |
Document ID | / |
Family ID | 1000005459114 |
Filed Date | 2021-07-01 |
United States Patent
Application |
20210196952 |
Kind Code |
A1 |
Bork; Toralf ; et
al. |
July 1, 2021 |
DEVICES AND METHODS FOR THE TREATMENT OF METABOLIC DISORDERS
Abstract
A system for stimulating the release of satiety hormone in a
subject comprises a stimulus device which is implantable in the
subject and adapted to apply an electrical stimulus to a tissue of
a gastrointestinal system of said subject, and a detection device
which is implantable in the subject and adapted to continuously
monitoring at least one of a mechanical characteristic and an
electrical characteristic of the subject to detect an ingestion of
food by said subject, wherein the detection device cooperates with
the stimulus device such that the stimulus device applies said
electrical stimulus in response to a detected ingestion of
food.
Inventors: |
Bork; Toralf; (Enges,
CH) ; Crivelli; Rocco; (Neuchatel, CH) ;
Miguras; Mathilde; (Lelocle, CH) ; Pfleiderer;
Martin; (Auvernier, CH) ; Tardy; Yanik; (Les
Geneveys Sur Coffrane, CH) ; Harris; Jason L.;
(Lebanon, OH) ; Ortiz; Mark S.; (Milford,
OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon Endo-Surgery, Inc. |
Cincinnati |
OH |
US |
|
|
Family ID: |
1000005459114 |
Appl. No.: |
17/201716 |
Filed: |
March 15, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16225215 |
Dec 19, 2018 |
10953224 |
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17201716 |
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15827216 |
Nov 30, 2017 |
10258795 |
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16225215 |
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15241479 |
Aug 19, 2016 |
9855424 |
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15827216 |
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13825459 |
Nov 3, 2014 |
9427580 |
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PCT/EP2012/055831 |
Mar 30, 2012 |
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15241479 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2005/0016 20130101;
A61N 1/0517 20130101; A61F 5/0026 20130101; A61F 2005/002 20130101;
A61N 1/0509 20130101; A61N 1/36007 20130101 |
International
Class: |
A61N 1/36 20060101
A61N001/36; A61N 1/05 20060101 A61N001/05; A61F 5/00 20060101
A61F005/00 |
Claims
1-20. (canceled)
21. A medical method, comprising: electronically detecting a
condition of food ingestion by a patient; changing one or more
preset parameter values of an electrical stimulation based on the
detection of the condition; and applying the electrical stimulation
to tissue of the patient, the electrical stimulation being applied
according to the one or more changed preset parameter values.
22. The method of claim 21, wherein changing one or more of the
preset parameter values includes changing at least one of voltage
of the electrical stimulation, frequency of the electrical
stimulation, pulse duration of the electrical stimulation, charge
of the electrical stimulation, and place of application of the
electrical stimulus at a tissue in a gastrointestinal lumen of the
patient.
23. The method of claim 21, further comprising, after the
electronic detection of the condition, classifying a type of the
food; wherein the preset parameter values are changed based on the
classified food type.
24. The method of claim 21, wherein the electronic detecting of the
condition includes a sensor implanted in the patient monitoring a
mechanical characteristic of the patient; and the mechanical
characteristic is at least one of pressure, acceleration, lumen
deformation, a drag force of a flow inside an intestine of the
patient, and lumen extension.
25. The method of claim 21, wherein the electronic detecting of the
condition includes a sensor implanted in the patient monitoring an
electrical characteristic of the patient; and the electrical
characteristic is at least one of pH inside a stomach of the
patient, electrical currents in a tissue of a gastrointestinal
tract of the patient, and electrical intraluminal impedance in a
lumen of the gastrointestinal tract of the patient.
26. The method of claim 21, wherein the parameters include at least
one of voltage, frequency, pulse duration, charge, and place of
application of the electrical stimulation in a gastrointestinal
lumen.
27. The method of claim 21, further comprising generating an
electrical signal having the one or more changed preset parameter
values; wherein applying the electrical stimulation includes an
electrode attached to the patient delivering the electrical signal
to the tissue.
28. The method of claim 21, wherein the electronic detection of the
condition includes a sensor implanted in the patient monitoring at
least one of a mechanical characteristic of the patient and an
electrical characteristic of the patient; the mechanical
characteristic is at least one of pressure, acceleration, lumen
deformation, a drag force of a flow inside an intestine of the
patient, and lumen extension; and the electrical characteristic is
at least one of pH inside a stomach of the patient, electrical
currents in a tissue of a gastrointestinal tract of the patient,
and electrical intraluminal impedance in a lumen of the
gastrointestinal tract of the patient.
29. The method of claim 21, wherein applying the electrical
stimulation includes a generator generating an electrical signal
and delivering the electrical signal to the tissue using an
electrode attached the patient.
30. The method of claim 21, wherein a detection device implanted in
the patient continuously monitors the patient for the condition of
food ingestion.
31. A medical method, comprising: activating a sensor implanted in
a patient to continuously monitor the patient to identify a
condition of food ingestion by the patient; and the identification
of the condition of food ingestion triggering calculating at least
one of voltage of an electrical signal, frequency of the electrical
signal, pulse duration of the electrical signal, charge of the
electrical signal, and place of application of the electrical
signal at a gastrointestinal tract of the patient, generating the
electrical signal using the calculated at least one of the voltage,
the frequency, the pulse duration of the electrical signal, the
charge, and the place of application, and delivering the generated
electrical signal to tissue of the patient.
32. The method of claim 31, wherein parameter values of the
electrical signal are preset; and the generating includes changing
the preset parameter values.
33. The method of claim 31, wherein the calculating is based on a
type of the food.
34. The method of claim 31, wherein a generator generates the
electrical signal, and an electrode attached to the tissue of the
patient delivers the generated electrical signal.
35. The method of claim 31, wherein the sensor continuously
monitors a mechanical characteristic of the patient; and the
mechanical characteristic is at least one of pressure,
acceleration, lumen deformation, a drag force of a flow inside an
intestine of the patient, and lumen extension.
36. The method of claim 31, wherein the sensor continuously
monitors an electrical characteristic of the patient; and the
electrical characteristic is at least one of pH inside a stomach of
the patient, electrical currents in a tissue of a gastrointestinal
tract of the patient, and electrical intraluminal impedance in a
lumen of the gastrointestinal tract of the patient.
37. The method of claim 31, wherein a control unit receives signals
from the sensor and identifies the condition of food ingestion by
the patient using the signals received from the sensor.
38. A medical system, comprising: a generator configured to
generate an electrical signal, at least one of voltage of the
electrical signal, frequency of the electrical signal, pulse
duration of the electrical signal, charge of the electrical signal,
and place of application of the electrical signal at a
gastrointestinal tract of the patient being based on a type of meal
ingested by a patient; and an electrode configured to deliver the
generated electrical signal to tissue of the patient.
39. The system of claim 38, further comprising a sensor configured
to detect a condition of food ingestion by a patient; and a control
unit configured to classify the type of meal based on a signal
received from the sensor.
40. The system of claim 38, further comprising a sensor configured
to be implanted in the patient and configured to monitor at least
one of a mechanical characteristic of the patient and an electrical
characteristic of the patient; the mechanical characteristic is at
least one of pressure, acceleration, lumen deformation, a drag
force of a flow inside an intestine of the patient, and lumen
extension; and the electrical characteristic is at least one of pH
inside a stomach of the patient, electrical currents in a tissue of
the gastrointestinal tract of the patient, and electrical
intraluminal impedance in a lumen of the gastrointestinal tract of
the patient.
Description
CROSS REFERENCE
[0001] The present application is a continuation of U.S.
application Ser. No. 16/225,215 entitled "Devices And Methods For
The Treatment Of Metabolic Disorders" filed Dec. 19, 2018, which is
a continuation of U.S. application Ser. No. 15/827,216 entitled
"Devices And Methods For The Treatment Of Metabolic Disorders"
filed Nov. 30, 2017, now U.S. Pat. No. 10,258,795, which is a
continuation of U.S. application Ser. No. 15/241,479 entitled
"Devices And Methods For The Treatment Of Metabolic Disorders"
filed Aug. 19, 2016, now U.S. Pat. No. 9,855,424, which is a
continuation of U.S. application Ser. No. 13/825,459 entitled
"Devices And Methods For The Treatment Of Metabolic Disorders"
filed Nov. 3, 2014, now U.S. Pat. No. 9,427,580, which is a
national stage application of PCT/EP2012/055831 entitled
"Implantable System For Providing Electrical Stimulation In
Response To Detecting An Ingestion Of Food" filed Mar. 30, 2012,
which are hereby incorporated by reference in their entireties.
FIELD OF THE INVENTION
[0002] The present invention relates generally to devices and
methods for the treatment of metabolic disorders using stimulation
of the gastrointestinal tract. More specifically, the present
invention relates to devices and methods for detecting meal or the
passage or presence of food in the GI tract in order to allow for a
timely and purposefully stimulation of the intestine in relation
with the presence of food. The present invention further relates to
a combined system for meal detection and electrical stimulation of
the small intestine (duodenum, jejunum or ileum) aiming at an
increased secretion of endogenous GLP-1 during meal intake.
BACKGROUND OF THE INVENTION
[0003] The human ability to store excess energy has contributed to
an increased frequency of morbidly obese patients and those with
Type 2 Diabetes. Patients having such conditions have increased
morbidity and mortality resulting from associated co-morbidities,
including cardiovascular disease and arthritis.
[0004] A sufficient release of Glucagon-Like Peptide (GLP-1), a
known key hormone that regulates the body's glucose control
hormone, is believed to alleviate Type 2 Diabetes and obesity.
Normally, the presence of nutrients, which arise from a meal
consisting of carbohydrates, fats and proteins, termed `digesta` in
the digestive tract, stimulates release of the body's own GLP-1 key
hormone into the blood stream. Key hormones, released by
specialized L-cells located in the mucosa, which is the innermost
interior (luminal) wall of the intestines, coordinate the body's
response to a meal. The hormones produce this effect by inducing a
sense of fullness and cessation of eating (satiety), triggering the
release of insulin to maintain proper glucose levels (incretin
effect) and slowing the passage of contents through the digestive
tract (delaying gastric emptying and slowing small intestinal
transit). Altogether, these effects have been referred to as the
"ileal brake" mechanism which involves both the hormones that play
a role (such as PYY, GLP-1, and GLP-2, among others), as well as
the multiplicity of effects of release of those hormones (gastric
emptying, a feeling of fullness cessation of eating, triggering of
insulin secretion).
[0005] An insufficient ileal brake, i.e., the inability of the body
to release sufficient quantities of these hormones in response to a
meal, is a contributory factor in obesity and Type 2 Diabetes.
While in non-obese non-diabetic individuals fasting levels of GLP-1
are observed to be in the range of 5-10 pmol/L and to increase
rapidly to 15-50 pmol/L after a meal, in T2D patients, the
meal-related increase in GLP-1 is significantly less. The decreased
insulin levels of such patients are attributable to an insufficient
level of GLP-1. Similarly, also in obese subjects lower basal
fasting hormone levels and smaller meal-associated rise of the
hormone levels have been observed. Therefore, enhancing the body's
endogenous levels of GLP-1 is believed to have impact on both
obesity and diabetes.
[0006] There are known pharmaceutical means to increasing the
endogenous active forms of GLP-1, e.g. by inhibition of its
breakdown by dipeptidyl peptidase-4 (DPP-4) inhibitors, such as
vildagliptin. In diabetic patients, improvement in glucose control
is obtained by increasing the circulating levels of GLP-1 by
vildagliptin.
[0007] As an alternative to pharmacological treatments, the most
effective treatment for morbid obesity is bariatric surgery. A
number of studies in patients after bariatric surgery suggest that
there are increases in meal-related circulating GLP-1 levels after
surgery, which contribute to the improvements in T2D and weight
loss noted. However, bariatric surgery is perceived as a highly
invasive measure recommended only for morbidly obese patients. A
less invasive approach using a duodenal impermeable sleeve placed
via an endoscope and fastened e.g. with a barbed metal anchor at
the duodenal entrance has also shown to improve the glucose
control.
[0008] It has been hypothesized that the manipulation of the
intestine during and after surgery resulted in a stimulation of the
mucosa which resulted in an increased release of the satiety
hormone(s). US2010/0056948 describes a method of stimulating the
release of satiety hormones in a subject comprising applying an
electrical stimulus to a tissue in the gastrointestinal system of
the subject contemporaneously with the contacting of L-cells of the
tissue with a nutrient stimulus.
[0009] However, there remains still a need of an improved timing of
the stimulation of the gastrointestinal system in relation with the
food intake and the passage of the food bolus through the
esophagus, stomach and intestine.
[0010] Currently available approaches for meal detection, such as
HRV (heart rate variability) monitoring or detection of electrical
signals in the duodenum are still to unspecific and indicate the
ingestion of meal with too much delay for a precise electrical
stimulation of the digestive system.
[0011] Also the proposed algorithms for so called artificial
pancreas systems rely only on rough estimates of nutrition intake
intervals which are indirectly derived from a continuous glucose
metering and are calibrated to trigger a subcutaneous insulin
administration in any case early enough to reach the blood stream
in a timely manner.
SUMMARY OF THE INVENTION
[0012] In one aspect, the present invention provides devices and
methods for detecting the food intake using one or a combination of
esophageal high resolution manometry (HRM) and esophageal
multichannel intraluminal impedance (MII). In another aspect, the
invention provides devices and methods for detecting the food
intake using one or a combination of detecting duodenal, gastric or
esophageal electrical activity, detecting gastric pH and detecting
esophageal and/or gastric movement and deformation.
[0013] In accordance with an aspect, duodenal, gastric or
esophageal electrical activity can be detected using mucosal,
serosal or cutaneous electrodes. Esophageal multichannel
intraluminal impedance (MII) measuring may be used to monitor and
record electrical impedance inside the esophagus in order to
classify the type of meal through its electric conductivity. For
this purpose multiple impedance transducers and associated pairs of
electrodes may be arranged inside the esophagus along at least a
portion of its length. Esophageal and gastric movements can be
monitored and recorded by individual or multiple pressure
transducers or strain gauges arranged at or inside the esophagus
and/or stomach, along at least a portion of their length.
Additionally, gastric pH can be detected by a pH meter arranged
inside the stomach.
[0014] In accordance with an aspect, multiple pressure transducers
and multiple pairs of electrodes are arranged along an elongate
string shaped support, e.g. a catheter or a sleeve, extended
endoluminally inside the esophagus and an esophageal contractive
activity is monitored using HRM and a classification or
identification of nutrition contents is accomplished on the basis
of their conductivity using MII.
[0015] In accordance with a further aspect, one or a combination of
a pressure transducer and an accelerometer are arranged near a jaw,
specifically near a lower jaw of a patient, e.g. onboard an ear
piece adapted to be fitted inside the ear canal, or onboard or
inside a tooth implant, crown or bridge, and a characteristic
chewing acceleration history and/or pressure history is monitored
and used to detect a food intake.
[0016] In yet another aspect, a continuous glucose monitoring (CGM)
is effected parallel to the detection of food intake and/or food
passage, for a controlled insulin release from an insulin pump in
dependency of the detected glucose levels.
[0017] In another aspect, the invention provides effecting an
electrical stimulation of the digestive system, particularly an
electrical stimulation of the mucosa of the small intestine
(duodenum, jejunum, ileum) in response to a detection of food
intake and/or food passage by the described food detection methods
and devices. The electrical stimulation may be accomplished in
dependency of food detection signals provided by the food detection
devices and a preset electrical gut stimulation program.
[0018] In an aspect of the invention there is provided a control
unit in signal communication with one or a combination of the food
detection sensors, i.e. pressure transducer/s, strain gauge/s, pH
meter, impedance transducer/s, accelerometer/s and glucose level
detector/s, the control unit being adapted to elaborate the signals
received from the food detection sensors to identify a condition of
food intake and, in response to the identified condition of food
intake, to generate a stimulus signal and provide the stimulus
signal to an electrical stimulus device.
[0019] In accordance with an aspect, the stimulus device may
comprise an electrical pulse generator and multiple electrodes
which can be arranged at a tissue of the gastrointestinal system,
particularly the small intestine.
[0020] In a further aspect, the food detection sensors, the control
unit and the stimulus device may be incorporated in an integrated
system or single integrated implantable device.
[0021] In accordance with a yet further aspect, the control unit
may also generate and provide an insulin release signal to an
insulin pump which determines the timing of insulin release and the
quantity of released insulin in dependency of the signals received
from the food detection sensors and from the continuous glucose
monitoring sensor.
[0022] In this manner, a closed loop meal detection and intestinal
electrical stimulation is provided for a purposeful and timely
release of the satiety hormone GLP-1, resulting in an improved
glycemic control and an appropriate feel of satiety in T2D and
obese patients.
[0023] Moreover, the contemporaneous detection of both the event of
food intake and the type of ingested food allows a more selective
response with regard to electrical stimulation, insulin dosing and
triggering of satiety and nausea enhancing measures.
[0024] In an aspect of the invention there is provided a method of
stimulating the release of satiety hormone in a subject, the method
comprising providing a stimulus device having a tissue engaging
portion, placing the stimulus device in a target location of a
gastrointestinal system of the subject such that the engaging
portion engage a tissue of the gastrointestinal system, and moving
the tissue engaging portion, thereby deforming the tissue of the GI
system.
[0025] These and other aspects and advantages of the present
invention shall be made apparent from the accompanying drawings and
the description thereof, which illustrate embodiments of the
invention and, together with the general description of the
invention given above, and the detailed description of the
embodiments given below, serve to explain the principles of the
present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] FIG. 1 illustrates a meal detection device in accordance
with an embodiment;
[0027] FIG. 2 illustrates a meal detection device in accordance
with a further embodiment;
[0028] FIG. 3 shows a schematic block diagram of a meal detection
and electrical stimulation system for stimulating the release of
satiety hormones in accordance with an embodiment;
[0029] FIG. 4A illustrates a meal detection device of FIG. 1 or 2
endoluminally extended inside the esophagus of a patient;
[0030] FIG. 4B illustrates a meal detection device of FIG. 1 or 2
endoluminally extended inside the duodenum of a patient;
[0031] FIG. 5 is a schematic flow charts showing closed loop meal
detection and gut stimulation and glucose level monitoring and
insulin release which can be performed individually or
contemporaneously;
[0032] FIG. 6 is a schematic flow charts showing closed loop meal
detection and gut stimulation and glucose level monitoring and
insulin release which can be performed individually or
contemporaneously;
[0033] FIG. 7 illustrates a meal detection and electrical
stimulation system for stimulating the release of satiety hormones
in accordance with embodiments, the systems being endoluminally
deployed inside the stomach and duodenum of a patient;
[0034] FIG. 8 illustrates a meal detection and electrical
stimulation system for stimulating the release of satiety hormones
in accordance with embodiments, the systems being endoluminally
deployed inside the stomach and duodenum of a patient;
[0035] FIG. 9A illustrates a meal detection and electrical
stimulation system for stimulating the release of satiety hormones
in accordance with embodiments, the systems being endoluminally
deployed inside the stomach and duodenum of a patient;
[0036] FIG. 9B illustrates an alternative arrangement of an
electrical stimulation device positioned externally around the
duodenum, the stimulation device being e.g. adapted to be used in
connection with the gastric food detection system in FIG. 9A;
[0037] FIG. 10A illustrates a meal detection and electrical
stimulation system for stimulating the release of satiety hormones
in accordance with embodiments, the systems being deployed in the
intraperitoneal space of a patient, with a meal detection device
fastened from the outside around the esophagus and an electrical
stimulation device fastened from the outside around the
duodenum;
[0038] FIG. 10B illustrates a meal detection and electrical
stimulation system for stimulating the release of satiety hormones
in accordance with embodiments, the systems being deployed in the
intraperitoneal space of a patient, with a meal detection device
fastened from the outside around the esophagus and an electrical
stimulation device fastened from the outside around the
duodenum;
[0039] FIG. 11A illustrates a meal detection and electrical
stimulation system for stimulating the release of satiety hormones
in accordance with embodiments, the systems being deployed in the
intraperitoneal space of a patient, with a meal detection device
fastened from the outside around the duodenum and an electrical
stimulation device fastened from the outside around the
duodenum;
[0040] FIG. 11B illustrates a meal detection and electrical
stimulation system for stimulating the release of satiety hormones
in accordance with embodiments, the systems being deployed in the
intraperitoneal space of a patient, with a meal detection device
fastened from the outside around the duodenum and an electrical
stimulation device fastened from the outside around the
duodenum;
[0041] FIG. 12A illustrates a meal detection and electrical
stimulation system for stimulating the release of satiety hormones
in accordance with embodiments, the systems being deployed in the
intraperitoneal space of a patient, with a meal detection and
electrical stimulation device integrated in a single ring or arch
fastened from the outside around the duodenum;
[0042] FIG. 12B illustrates a meal detection and electrical
stimulation system for stimulating the release of satiety hormones
in accordance with embodiments, the systems being deployed in the
intraperitoneal space of a patient, with a meal detection and
electrical stimulation device integrated in a single ring or arch
fastened from the outside around the duodenum;
[0043] FIG. 13 illustrates a meal detection and electrical
stimulation system for stimulating the release of satiety hormones
in accordance with further embodiments;
[0044] FIG. 14 illustrates a meal detection and electrical
stimulation system for stimulating the release of satiety hormones
in accordance with further embodiments;
[0045] FIG. 15 is a schematic cross-section of a wall portion of
the devices in FIGS. 13 and 14;
[0046] FIG. 16 illustrates a meal detection device placed in a
patients ear in accordance with a further embodiment;
[0047] FIG. 17 shows a schematic block diagram of a meal detection
and electrical stimulation system for stimulating the release of
satiety hormones in accordance with an embodiment;
[0048] FIG. 18 illustrates a meal detection device placed on a
patient's jaw in accordance with further embodiments;
[0049] FIG. 19 illustrates a meal detection device placed on a
patient's jaw in accordance with further embodiments; and
[0050] FIG. 20 illustrates a meal detection device placed on a
patient's jaw in accordance with further embodiments.
DETAILED DESCRIPTION OF EMBODIMENTS
[0051] Referring to the drawings in which like numerals denote like
anatomical structures and components throughout the several views,
a method is provided for stimulating the release of satiety
hormone, specifically GLP-1, in a human subject. In general terms,
the method comprises continuous monitoring of at least one of a
mechanical characteristic and an electrical characteristic of the
subject to detect an ingestion of food by the subject, and applying
an electrical stimulus to a tissue of a gastrointestinal system of
the subject in response to a detected ingestion of food.
[0052] In accordance with an embodiment, both a mechanical and an
electrical characteristic are continuously monitored in a
gastrointestinal system of the subject, the gastrointestinal system
including mouth, esophagus, stomach, small intestine and colon. In
dependency from the monitored mechanical characteristic a decision
is taken whether an ingestion of food has occurred and the ingested
food is classified in dependency of the monitored electrical
characteristic.
[0053] The nutrients contained in a food bolus can be identified
through its electrical conductivity and the classification of the
ingested food may be effected in dependency of the identified
nutrients, such as carbohydrates, proteins, fats, vitamins,
minerals, roughage, water.
[0054] One or any combination of a voltage, frequency, pulse
duration, charge and place of application of the electrical
stimulus at a tissue in the lumen of the gastrointestinal system
may be determined and varied in dependency from a preset electrical
gut stimulation program and from the classification of the ingested
food.
[0055] In exemplary embodiments, the electrical stimulus may be
applied and varied at a frequency of about 0.1 Hz to about 90 Hz,
at a voltage of about 0.5 V to about 25 V, with a pulse duration of
about 0.1 ms to about 500 ms. The electrical current may have a
charge of about 1 .mu.C to about 6000 .mu.C, inclusive. The
electrical stimulus may be applied to a mucosal tissue of the
gastrointestinal system of the subject, e.g. in a duodenum, jejunum
or ileum.
[0056] In accordance with embodiments, the monitored mechanical
characteristic may comprise one or a combination of a pressure,
acceleration, lumen deformation, lumen extension or drag force
exerted by the flow of contents through the GI tract.
[0057] The monitored electrical characteristic may comprise one or
a combination of electrical currents in a tissue of the
gastrointestinal system and electrical intraluminal impedance in a
lumen of the gastrointestinal system, specifically in an esophagus
or in a duodenum.
[0058] In accordance with an embodiment, parallel to the continuous
monitoring of the mechanical and/or electrical characteristic a
glucose concentration may be continuously monitored in the subject
to detect glucose levels, and insulin is released in the subject in
dependency of the detected glucose levels.
[0059] Within the present description of the invention, the
expression "continuous monitoring" means a timed (for instance
every few minutes or seconds") repetition of measuring or detecting
a characteristic over an entire treatment period (of e.g. some
days, weeks, months or even years) which yields a series of
measured or detected values of the characteristic and provides a
current value of the characteristic at any time during the
treatment period.
[0060] Detailed Description of Embodiments of FIGS. 1 to 4 a
[0061] In accordance with an embodiment (FIGS. 1 to 4A), a pressure
inside the esophagus 6 of the subject is continuously monitored by
means of esophageal high resolution manometry (HRM) to detect the
passage of food through the esophagus 6. Contemporaneously, an
electrical impedance is continuously monitored inside the esophagus
6 of the subject by means of multichannel intraluminal impedance
(MII) and the detected food is classified in dependency of the
monitored electrical impedance at the time of passage of the food
bolus through the esophagus 6.
[0062] For this purpose, multiple pressure transducers 7 and
multiple pairs of electrodes 8 are fastened to a flexible elongate
support, e.g. a catheter 9 (FIG. 1) or a flexible esophageal sleeve
10 (FIG. 2) and the elongate support is endoluminally extended
inside the esophagus 6 and anchored therein to stay in place. The
esophageal high resolution manometry (HRM) is then carried out by
means of the multiple pressure transducers 7 and the multichannel
intraluminal impedance (MII) is carried out by means of the
multiple pairs of electrodes 8.
[0063] The esophageal manometry may be carried out to perform both
quantitative and qualitative measurements of esophageal pressure
and peristaltic coordination. The elongate support sleeve 10 or
catheter 9 may have a length of about 30 cm to 36 cm and carry a
row of from 30 to 40 solid-state circumferential pressure sensors 7
spaced at constant intervals along the entire support length. Such
an arrangement facilitates pressure assessment of the entire
esophagus, from the pharynx to the LES. The pressure transducers 7
are linked to a control unit 2 (a microchip with a memory, a
battery, and a data acquisition and elaboration software) for rapid
interpretation of the monitored pressure values. The control unit 2
may be directly connected to the elongate support or,
alternatively, the control unit 2 may be arranged remote from the
elongate support.
[0064] As illustrated in the block diagram in FIG. 3, the control
unit 2 is in signal communication (by conductive wire or wireless,
e.g. by an RF transmitter-receiver communication channel) with an
electrical stimulus device 11.
[0065] The control unit 2 is adapted to elaborate the signals
received from the food detection sensors (pressure transducers 7,
impedance electrodes 8) to identify a condition of food intake and,
in response to the identified condition of food intake, to generate
a stimulus signal and provide the stimulus signal to the electrical
stimulus device 11.
[0066] The stimulus device 11 may comprise an electrical pulse
generator 12 and multiple stimulation electrodes 13 which are
intended to be arranged at a tissue of the gastrointestinal system,
particularly the small intestine.
[0067] Additionally, a continuous glucose monitoring (CGM) may be
performed to determine current glucose levels, e.g. with
measurement intervals in the range of 2 to 5 minutes. For this
purpose a glucose sensor 1 may be placed in contact with bodily
fluid of the patient, e.g. under the skin, and linked by a signal
communication line to the control unit 2 or to an additional
control unit in signal communication (by conductive wire or
wireless, e.g. by an RF transmitter-receiver communication channel)
with an insulin pump 3 with associated insulin reservoir.
[0068] In accordance with a further exemplary embodiment,
additionally to the continuous monitoring of the mechanical and/or
electrical characteristic and, if provided, to the glucose level
monitoring, a pH may be continuously monitored inside the stomach 5
of the subject to detect an ingestion of food by the subject.
[0069] For this purpose a pH meter 4 may be placed inside the
stomach 5 and linked by a signal communication line (by conductive
wire or wireless, e.g. by an RF transmitter-receiver communication
channel) to the control unit 2.
[0070] In an embodiment (FIGS. 1, 2 and 4A), the pH meter 4 is
attached to a distal end portion 14 of the elongate support
(esophageal sleeve 10 or esophageal catheter 9) which can extend
inside the stomach 5 while a prevalent length of the elongate
support extends inside the esophagus 6.
[0071] It will be readily understood that the same control unit 2
may also generate and provide an insulin release signal to the
insulin pump 3 which determines the timing of insulin release and
the dosage of released insulin in dependency of the signals
received from the food detection sensors (pressure transducers 7,
impedance electrodes 8, pH meter 4) and from the continuous glucose
sensor 1.
[0072] In this manner, a closed loop meal detection and intestinal
electrical stimulation is provided for a purposeful and timely
release of the satiety hormone GLP-1, resulting in an improved
glycemic control and an appropriate feel of satiety in T2D and
obese patients.
[0073] Moreover, the contemporaneous detection of both the event of
food intake and the type of ingested food allows a more selective
response with regard to electrical stimulation, insulin dosing and
triggering of satiety and nausea enhancing measures.
[0074] Detailed Description of Embodiments of FIG. 4 b
[0075] In accordance with an embodiment (FIG. 4B) the device
described in relation with FIGS. 1 to 4A is anchored inside the
stomach 5. The proximal end of the elongate support (catheter 9 or
endoluminal sleeve 10) is anchored inside a stomach 5, e.g. by
means of a balloon or coil shaped expandable anchoring body 20, and
the elongate support is extended from inside the stomach 5 into the
duodenum 15. In this manner the monitoring of the pressure and of
the electrical impedance may be effected in the duodenum 15.
Additionally the stimulus electrodes 13 are arranged at the
elongate support (here a duodenal sleeve or a duodenal catheter) to
engage the duodenal mucosa. The pH meter 4 and also the pulse
generator 12 can be arranged at the anchoring body 20.
[0076] Detailed Description of Embodiments of FIG. 7
[0077] In accordance with a further embodiment (FIG. 7), the method
comprises continuously monitoring a drag force of a flow inside a
duodenum 15 of the subject in order to detect an ingestion of food
by the subject.
[0078] For this purpose a flexible string shaped support medium 17
is provided and at least one strain gauge sensor 16 is attached to
the support medium so that it can measure tensile forces
transmitted by the support medium 17 in response to a flow of
intestinal contents along the support medium 17. The ingestion of a
meal is detected in dependency of the monitored flow variation
inside the duodenum 15 during the transit of a food bolus.
[0079] The string shaped support medium 17 has a proximal end 18
and a distal end 19. The proximal end 18 of the support medium 17
is anchored inside a stomach 5, e.g. by means of a balloon or coil
shaped expandable anchoring body 20, and the support medium 17 is
extended from inside the stomach 5 into the duodenum 15. In order
to increase the detectable pull at the support medium 17 an
enlargement 21 may be formed distally to the strain gauge 16.
[0080] The strain gauge 16 is linked to a control unit 2 (a
microchip with a memory, a battery, and a data acquisition and
elaboration software) for rapid interpretation of the monitored
drag force values. The control unit 2 may be advantageously housed
in the anchoring body 20 and is in signal communication (by
conductive wire or wireless, e.g. by an RF transmitter-receiver
communication channel) with an electrical stimulus device 11.
[0081] The control unit 2 is adapted to elaborate the signals
received from the food detection sensors (strain gauge 16 and, if
provided, pH meter 4) to identify a condition of food intake and,
in response to the identified condition of food intake, to generate
a stimulus signal and provide the stimulus signal to the electrical
stimulus device 11.
[0082] The stimulus device 11 may comprise an electrical pulse
generator 12 which may be received in the anchoring body 20 and
multiple stimulation electrodes 13 arranged at the support medium
17 in order to engage a mucosa of the duodenum 15.
[0083] Additionally, a continuous glucose monitoring (CGM) and
controlled insulin release in dependency of the detected glucose
levels may be performed by the previously described method steps
and device arrangements.
[0084] In accordance with a further exemplary embodiment,
additionally to the continuous monitoring of the mechanical and/or
electrical characteristic and, if provided, to the glucose level
monitoring, a pH may be continuously monitored inside the stomach 5
of the subject to detect an ingestion of food by the subject.
[0085] For this purpose a pH meter 4 may be placed inside the
stomach 5 and linked by a signal communication line (by conductive
wire or wireless, e.g. by an RF transmitter-receiver communication
channel) to the control unit 2.
[0086] In an embodiment (FIG. 7), the pH meter 4 can be directly
fastened to the proximal anchoring body 20 which is placed within
the stomach 5.
[0087] Detailed Description of Embodiments of FIGS. 8 to 9 b
[0088] In accordance with an embodiment (FIGS. 8 through 9B), the
method comprises continuously monitoring a pressure inside the
stomach 5 of the subject and continuously monitoring an electrical
current in a gastric wall of the subject in order to detect the
ingestion of food by the subject.
[0089] For this purpose, a pressure sensor 7, at least a pair of
electrodes 8 and a pH meter 4 are arranged on an expandable balloon
shaped or coil shaped anchoring body 20, the anchoring body 20 is
inserted inside the stomach 5 of the patient and then expanded such
that the pressure sensor 7 and the electrodes 8 engage the gastric
wall and the anchoring body 20 holds itself inside the stomach 5.
After placement of the anchoring body 20, the pressure in the
stomach 5 is monitored by means of the pressure sensor 7 and the
electrical current in the gastric wall is monitored by means of the
electrodes 8.
[0090] The pressure sensor 7 and the electrodes 8 are linked to a
control unit 2 (a microchip with a memory, a battery, and a data
acquisition and elaboration software) for rapid interpretation of
the monitored pressure and current or electrical impedance values
inside the stomach 5. The control unit 2 may be advantageously
housed in the anchoring body 20 and is in signal communication (by
conductive wire or wireless, e.g. by an RF transmitter-receiver
communication channel) with an electrical stimulus device 11.
[0091] The control unit 2 is adapted to elaborate the signals
received from the food detection sensors (pressure sensor 7,
electrodes 8 and, if provided, pH meter 4) to identify a condition
of food intake and, in response to the identified condition of food
intake, to generate a stimulus signal and provide the stimulus
signal to the electrical stimulus device 11.
[0092] The stimulus device 11 may comprise an electrical pulse
generator 12 which may be received in the anchoring body 20 and one
or more pairs of stimulation electrodes 13 provided at a distance
from the anchoring body 20 and connected by electrical wires 22
(FIG. 8) to the pulse generator 12, so that the wires 22 can extend
from the anchoring body 20 which is placed inside the stomach 5
through the pylorus down into the duodenum 15 where the electrodes
13 engage a mucosa of the duodenum 15. In this embodiment, the
electrical wires 22 may accomplish both electrical energizing and
mechanical anchoring of the electrodes 13.
[0093] FIGS. 8 and 9 show examples of coiled or corkscrew shaped
electrode 13 arrangements adapted to engage the duodenal wall
without obstructing the duodenum lumen.
[0094] Additionally, a continuous glucose monitoring (CGM) and
controlled insulin release in dependency of the detected glucose
levels may be performed analogously to the previously described
method steps and device arrangements.
[0095] In accordance with a further exemplary embodiment,
additionally to the continuous monitoring of the mechanical and/or
electrical characteristic and, if provided, to the glucose level
monitoring, a pH may be continuously monitored inside the stomach 5
of the subject to detect an ingestion of food by the subject.
[0096] For this purpose a pH meter 4 may be placed inside the
stomach 5 and linked by a signal communication line (by conductive
wire or wireless, e.g. by an RF transmitter-receiver communication
channel) to the control unit 2.
[0097] In an embodiment (FIG. 7), the pH meter 4 can be directly
fastened to the proximal anchoring body 20 which is placed within
the stomach 5.
[0098] In accordance with a further variant (FIG. 9A) the pulse
generator 12 is connected to an RF transmitter circuit and antennae
23 for a wireless transmission of the electrical stimulation energy
and signals, and the electrode 13 arrangement comprises an RF
receiving circuit and antenna 24 for a wireless reception of the
stimulation energy and signals. In this embodiment, the wires 22
are not necessary, however, the electrode 13 arrangement must be
directly anchored inside the duodenum 15 or connected to the
anchoring body 20 by means of an anchoring wire.
[0099] In a yet further embodiment, an electrical stimulation band
25 adapted to be brought in a ring shaped configuration is (e.g.
laparoscopically) arranged around the duodenum 15, and the
stimulation electrodes 13 are provided on a radially internal
surface of the stimulation band 25 to engage the duodenum 15 from
outside. Also in this embodiment, the pulse generator 12 is
connected to an RF transmitter circuit and antennae 23 for a
wireless transmission of the electrical stimulation energy and
signals, and the stimulation band 25 carries an RF receiving
circuit and antenna 24 for a wireless reception of the stimulation
energy and signals.
[0100] Detailed Description of Embodiments of FIGS. 10 a to 12
b
[0101] In accordance with an embodiment, the method comprises
continuously monitoring a hoop deformation (or, in other words: a
change in circumference) caused by peristalsis of one of a duodenal
wall and a distal esophageal wall of the subject in order to detect
an ingestion of food by the subject.
[0102] For this purpose a band 27 is provided which is configured
to be deformable from an open shape to a closed ring shape and
lockable in the closed ring shape. A strain gauge 26 is arranged on
the band 27 such that it can detect hoop stresses in the band 27 or
variations of the (circumferential) length of the band 27. The band
27 is placed around one of a duodenum 15 and a distal esophagus 6
of the subject, e.g. by laparoscopy or open surgery.
[0103] Placement of the band 27 may also be effected by endolumenal
transportation of the band 27 to the desired site for monitoring
the hoop deformation, translumenal placement of the band 27 from
inside the esophagus or duodenum through an incision in the lumen
wall to its outside and extension of the band from outside the
lumen around the lumen.
[0104] After placement of the band 27 around the duodenum 15 or
esophagus 6, the hoop deformation of the duodenum 15 or esophagus 6
can be monitored by means of the strain gauge 26.
[0105] The strain gauge 26 is linked to a control unit 2 (a
microchip with a memory, a battery, and a data acquisition and
elaboration software) for rapid interpretation of the monitored
hoop deformation. The control unit 2 may be directly connected to
the band 27 or, alternatively, the control unit 2 may be arranged
remote from the band 27.
[0106] The control unit 2 is in signal communication (by conductive
wire or wireless, e.g. by an RF transmitter-receiver communication
channel) with an electrical stimulus device 11.
[0107] The control unit 2 is adapted to elaborate the signals
received from the food detection sensors (in the present
embodiment: the strain gauge 26) to identify a condition of food
intake and, in response to the identified condition of food intake,
to generate a stimulus signal and provide the stimulus signal to
the electrical stimulus device 11.
[0108] The stimulus device 11 may comprise an electrical pulse
generator 12 and multiple stimulation electrodes 13 arranged at a
tissue of the gastrointestinal system, particularly the small
intestine.
[0109] In accordance with an embodiment, the stimulus device 11
includes a stimulus band 25 (similar to the one described in
connection with FIG. 9B) which is configured to be deformable from
an open shape to a closed ring shape and lockable in the closed
ring shape. Multiple stimulation electrodes 13 are arranged at the
stimulus band 25 such that they can contact a lumen (small
intestine, duodenum) when the stimulus band 25 is placed around the
lumen.
[0110] In an embodiment (FIG. 10A), the control unit 2 and the
pulse generator 12 may be onboard the detecting band 27 and
connected to an RF transmitter circuit and antennae 23 (onboard the
detecting band 27) for a wireless transmission of the electrical
stimulation energy and signals, and the stimulation band 25 carries
an RF receiving circuit 24 and antenna for a wireless reception of
the stimulation energy and signals.
[0111] In an alternative embodiment, the control unit 2 may be
onboard the detecting band 27 and is connected to an RF transmitter
circuit and antennae 23 (onboard the detecting band 27) for a
wireless transmission of the stimulation signals to the pulse
generator 12, and the stimulation band 25 carries the pulse
generator 12 and an RF receiving circuit 24 and antenna for a
wireless reception of the stimulation signals.
[0112] In a yet further embodiment (FIGS. 10B and 11B), the control
unit 2 may be onboard the detecting band 27 and is connected to an
RF transmitter circuit and antennae 23 (onboard the detecting band
27) for a wireless transmission of the stimulation signals to the
pulse generator 12, and the pulse generator 12 with the RF
receiving circuit 24 and antenna for a wireless reception of the
stimulation signals is arranged remote from the stimulation band 25
and electrically connected thereto by conductive wire 22. In this
case, the pulse generator 12 can be placed at a distance both from
the detecting band 27 and from the stimulating band 25, e.g. inside
the abdominal space of the patient.
[0113] In a further embodiment (FIG. 11A), the control unit 2 may
be onboard the detecting band 27 and is connected by conductive
wire 22 to the pulse generator 12, and the pulse generator 12 is
connected by conductive wire 22 to the stimulation band 25. Also in
this embodiment, the pulse generator 12 can be placed at a distance
both from the detecting band 27 and from the stimulating band 25,
e.g. inside the abdominal space of the patient.
[0114] In an embodiment (FIG. 12A), the pulse generator 12 is
connected to an RF transmitter circuit and antennae 23 for a
wireless transmission of the electrical stimulation energy and
signals, and the stimulation band 25 carries an RF receiving
circuit 24 and antenna for a wireless reception of the stimulation
energy and signals.
[0115] In a preferred embodiment (FIGS. 12A, 12B), the detection
band 27 and the stimulation band 25 are integrated in one single
detection and stimulation band which can be placed around the
duodenum 15 and which carries both the at least one strain gauge 26
for detecting the ingestion of food and the stimulus electrodes 13
for stimulating the GLP-1 secretion. Also in this embodiment, the
control unit 2 and/or the pulse generator 12 may be directly
onboard the band or at a distance to the band and connected by
conductive wire or by wireless RF communication as described in
connection with the previous embodiments.
[0116] Additionally, a continuous glucose monitoring (CGM) may be
performed to determine current glucose levels and a dosage and
release of insulin in the subject in dependency from the detected
glucose levels may be performed by means of the previously
described methods and devices.
[0117] In accordance with a further exemplary embodiment,
additionally to the continuous monitoring of the hoop deformation
of the esophageal wall or duodenal wall and, if provided, to the
glucose level monitoring, a pH may be continuously monitored inside
the stomach 5 of the subject to detect or confirm an ingestion of
food by the subject.
[0118] For this purpose a pH meter 4 may be placed inside the
stomach 5 and linked by a signal communication line (by conductive
wire or wireless, e.g. by an RF transmitter-receiver communication
channel) to the control unit 2.
[0119] Detailed Description of Embodiments of FIGS. 13 to 15
[0120] In accordance with an embodiment (FIGS. 13, 14), the method
may comprise continuously monitoring an electrical current in a
duodenal wall of the subject in order to detect an ingestion of
food by the subject.
[0121] For this purpose at least a pair of detecting electrodes 8
is arranged on an expandable tubular stent 28, e.g. a mesh shaped
stent or a coil shaped stent, and the stent 28 is then placed
inside the duodenum 15 of the subject and expanded therein such
that the detecting electrodes 8 engage the duodenal wall and the
stent remains anchored inside the duodenum 15. Then the electrical
current in the duodenal wall can be monitored by means of the
electrodes 8 which are linked to a control unit 2 (a microchip with
a memory, a battery, and a data acquisition and elaboration
software) for rapid interpretation of the monitored electrical
activity. The control unit 2 may be directly connected to the stent
28 or, alternatively, the control unit 2 may be arranged remote
from the stent 28.
[0122] The control unit 2 is in signal communication (by conductive
wire or wireless, e.g. by an RF transmitter-receiver communication
channel) with an electrical stimulus device 11.
[0123] The control unit 2 is adapted to elaborate the signals
received from the food detection sensors (in the present
embodiment: the detection electrodes 8) to identify a condition of
food intake and, in response to the identified condition of food
intake, to generate a stimulus signal and provide the stimulus
signal to the electrical stimulus device 11.
[0124] The stimulus device 11 may comprise an electrical pulse
generator 12 and multiple stimulation electrodes 13 arranged at a
tissue of the gastrointestinal system, particularly the small
intestine.
[0125] In a preferred embodiment, the entire stimulus device 11 or
at least the stimulation electrodes 13 are directly connected to
the same expandable stent 28, so that the release of the GLP-1 can
be triggered in response to a detected food passage at the stent 28
without time delay at the very same location of the stent 28 within
the duodenum 15.
[0126] In accordance with embodiments, the pulse generator 12 may
be remote from the stent 28 and in wireless RF communication or
electrical cable connection with the control unit 2 and/or the
stimulus electrodes 13.
[0127] In accordance with an embodiment, the stent 28 is built as a
multilayer stent (FIG. 15) having at least in one portion thereof
an external electrode layer 29, e.g. a platinum layer coated with
iridium oxide, an electronic circuit layer 30 beneath the electrode
layer 29, which contains the control unit 2 and, if provided, the
stimulation device 11 with an RF receiver circuit with antennae
and/or an RF transmitter circuit with antenna, an insulation layer
31, e.g. in polyamide, provided beneath the circuit layer 30, and a
structural layer 32 made from a shape memory alloy and arranged
beneath the insulation layer 31.
[0128] Detailed Description of Embodiments of FIGS. 16 to 20
[0129] In accordance with an embodiment (FIGS. 16 to 20), the
method may comprise continuously monitoring a chewing movement of
the patient by monitoring at least one of an acceleration and a
pressure at a lower jaw of the patient to detect an ingestion of
food.
[0130] For this purpose an accelerometer 33 may be arranged inside
an ear channel 36 of the subject and the acceleration at the lower
jaw may be monitored by means of the accelerometer 33.
[0131] In accordance with an embodiment (FIGS. 16, 17) a head set
or earpiece 34 is provided which has an insert portion 35 which can
be fitted inside the ear channel 36. The accelerometer 33 is
received in the insert portion 35 of the earpiece 34. The
accelerometer 33 is linked to a control unit 2 (a microchip with a
memory, a battery, and a data acquisition and elaboration software)
for rapid interpretation of the monitored acceleration history. The
control unit 2 may be directly received inside the insert portion
35 or housed in an external part of the headset or earpiece 34 or,
alternatively, the control unit 2 may be arranged remote from the
earpiece 34.
[0132] As illustrated in the block diagram in FIG. 17 (which refers
to both the embodiments of FIG. 16 and of FIGS. 18 to 20), the
control unit 2 is in signal communication (by conductive wire or
wireless, e.g. by an RF transmitter-receiver communication channel)
with an electrical stimulus device 11.
[0133] The control unit 2 is adapted to elaborate the signals
received from the food detection sensors (accelerometer 33) to
identify a condition of food intake and, in response to the
identified condition of food intake, to generate a stimulus signal
and provide the stimulus signal to the electrical stimulus device
11.
[0134] The stimulus device 11 may comprise an electrical pulse
generator 12 and multiple stimulation electrodes 13 arranged at a
tissue of the gastrointestinal system, particularly the small
intestine. The stimulus device 11 can be configured, implanted and
operated as described in connection with the previous
embodiments.
[0135] The control unit 2 is adapted to discern the differences
between the jaw acceleration history during the ingestion of a meal
from those during other activities like chewing a gum, swallowing
saliva, speaking or singing, in order to avoid false positive
scenarios. In response to the detection of an ingested meal, the
control unit 2 will pilot the stimulus device 11 so that the latter
applies an electrical pulse stimulation to the GI tract,
particularly to the small intestine, thereby increasing the
secretion of endogenous GLP-1. The earpiece 34 or head set may be
powered by an onboard replaceable battery set.
[0136] In accordance with a yet further embodiment (FIGS. 17 to
20), the method step of detecting the ingestion of food comprises
monitoring a pressure by means of a pressure transducer 7 arranged
inside a tooth implant 37 directly at the lower jaw of the patient.
Alternatively or in combination, an acceleration may be monitored
by means of an accelerometer 33 arranged inside the tooth implant
37.
[0137] For this purpose the tooth implant 37 may be configured as a
crown or capsule implant (FIG. 19), a bridge implant (FIG. 20) or a
tooth root implant (FIG. 18) and receives the pressure transducer 7
and/or the accelerometer 33. Also in this embodiment, the
accelerometer 33 and/or the pressure sensor 7 is linked to a
control unit 2 (a microchip with a memory, a battery, and a data
acquisition and elaboration software) for rapid interpretation of
the monitored pressure and/or acceleration history. The control
unit 2 may be directly received inside the tooth implant 37 or,
alternatively, the control unit 2 may be arranged remote from the
earpiece 34. For the wireless signal transmission between the
control unit and the food detection sensors and/or the stimulus
device, an RF transmitter circuit and antennae 23 and a
corresponding RF receiving circuit and antenna are provided.
[0138] As illustrated in the block diagram in FIG. 17, the control
unit 2 is in signal communication (by conductive wire or wireless,
e.g. by an RF transmitter-receiver communication channel) with an
electrical stimulus device 11.
[0139] The control unit 2 is adapted to elaborate the signals
received from the food detection sensors (accelerometer 33,
pressure sensor 7) to identify a condition of food intake and, in
response to the identified condition of food intake, to generate a
stimulus signal and provide the stimulus signal to the electrical
stimulus device 11.
[0140] The dental implant 37 is implanted in the mouth of the
patient, preferably in the lower jaw, by known dental procedures.
The control unit 2 is adapted to discern the differences between
the jaw acceleration history and/or the chewing pressure history
during the ingestion of a meal from those during other activities
like chewing a gum, swallowing saliva, speaking or singing, in
order to avoid false positive scenarios. In response to the
detection of an ingested meal, the control unit 2 will pilot the
stimulus device 11 so that the latter applies an electrical pulse
stimulation to the GI tract, particularly to the small intestine,
thereby increasing the secretion of endogenous GLP-1.
[0141] All described embodiments of the present invention provide a
closed loop meal detection and intestinal electrical stimulation
for a purposeful and timely release of the satiety hormone GLP-1,
resulting in an improved glycemic control and an appropriate feel
of satiety in T2D and obese patients.
[0142] Although preferred embodiments of the invention have been
described in detail, it is not the intention of the applicant to
limit the scope of the claims to such particular embodiments, but
to cover all modifications and alternative constructions falling
within the scope of the invention.
* * * * *