Treatment of the autonomic nervous system

• US 7,664,551 B2
• Filed: 07/06/2005
• Issued: 02/16/2010
• Est. Priority Date: 07/07/2004
• Status: Expired due to Fees

• Current Assignee: Medtronic Transneuronix, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Transneuronix, Inc. (Medtronic Plc)
• Inventors: Cigaina, Valerio
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US11/175,626
• Publication Number:
  US 20060058851A1
• Time in Patent Office: 1,686 Days
• Field of Search: 607/5, 607/40, 607/58
• US Class Current: 607/40
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

Systems and methods are provided for modulating the autonomic nervous system by the electrical stimulation of the neuro-muscular system of a patient, and include an implantable electrical system for gastrointestinal stimulation which incorporates a heart rate sensor to indicate the neurovegetative patient condition, to initiate and terminate stimulation at specific locations, and an algorithm to automatically control electrical stimulation frequency, interval, amplitude, or a combination of such parameters for adaptive treatment of obesity, anorexia, other eating disorders, diseases related with the so called “metabolic syndrome” (e.g., impaired glucose tolerance and diabetes type 2, GERD, systemic hypertension, early arterovascular degeneration, early senility, and the like), and disorders related to a pathologic imbalance of the autonomic nervous system.

Claims

1. An implantable gastrointestinal neuromuscular pulse generator system comprising:

a pulse generator to provide electrostimulation;

one or more leads with electrodes for attachment to gastrointestinal tissue; and

a controller which stimulates or withholds electrostimulation, based upon sensed heart rate parameters, to the gastrointestinal tissue through the one or more leads,

wherein the sensed heart rate parameters include;

length between heart beat intervals (R to R);

length between intra-beat intervals;

length of T wave;

or

combinations thereof.

2. The implantable gastro-intestinal neuromuscular pulse generator system of claim 1, wherein the sensed heart rate parameters is the length between heart beat intervals (R to R).

3. The implantable gastrointestinal neuromuscular pulse generator system of claim 1, wherein the sensed heart rate parameters are measured and compared prior to, and after, stimulation or withholding of electrostimulation.

4. A method for treatment of a functional disorder related to balance of an autonomic nervous system with functional prevalence of a sympathetic or a parasympathetic component in a patient, said method comprising:

implanting a first electrical stimulation device comprising one or more first electrical stimulation leads and a first electrical connector for attachment to a first pulse generator such that the one or more first electrical stimulation leads are attached to, or adjacent to, the patient'"'"'s stomach, whereby electrical stimulation can be provided to the stomach through the one or more first electrical stimulation leads;

implanting a second electrical stimulation device comprising one or more second electrical stimulation leads and a second electrical connector for attachment to the first or potentially a second pulse generator such that the one or more second electrical stimulation leads are attached to, or adjacent to, the patient'"'"'s small intestines, whereby electrical stimulation can be provided to the patient'"'"'s small intestines through the one or more second electrical stimulation leads;

placing a sensing element on or in the patient'"'"'s body to periodically monitor the patient HRV and compute the P1/P2 ratio, and wherein the sensing element, activates at least one of the first or second electrical stimulation devices to supply programmable electrical stimulation to the patient'"'"'s GI tract;

wherein the sensing element resumes monitoring and computation of the HRV ratio and further adjusts the pacing to achieve a desired ratio.