Safety features for use in medical devices

• US 9,393,420 B2
• Filed: 03/11/2013
• Issued: 07/19/2016
• Est. Priority Date: 03/09/2012
• Status: Expired due to Fees

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: EnteroMedics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Almendinger, Al, Spar, Gregory Pat, Weijand, Koen Jacob, Maas, Randy, Ellsworth, Steve
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US13/793,715
• Publication Number:
  US 20130238048A1
• Time in Patent Office: 1,226 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/37276 characterised by means for reducing power consumption during telemetry
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A therapy system for applying an electrical signal to an internal anatomical feature of a patient includes an implantable component and an external component. The medical device can be checked for safety issues by periodically initiating a sequence of tests of an H-bridge circuit, and, during each test, monitoring a current flow through a sensing resistor electrically connected between a sensing connection of the H-bridge circuit and a ground. Current flow through the sensing resistor indicates that both series electrical switches within at least one of the two pairs of series electrical switches are active during that test.

Claims

1. A method of recharging an implantable neuroregulator containing a rechargeable battery comprising

measuring a baseline temperature of the implantable neuroregulator at a predetermined time prior to a charging session;

measuring a rate of rise in temperature or a rise in temperature of the implantable neuroregulator from the baseline temperature during a charging session;

selecting a variable or constant rate of charge of the battery based on the rise of temperature or the rate of rise of the temperature of the implantable neuroregulator, wherein the variable or constant rate of charge is selected to not cause an increase in the rate of rise in temperature beyond a predetermined unsafe rate or the temperature of the implantable neuroregulator beyond a predetermined maximum safe temperature over the baseline temperature, wherein the constant or variable rate of charge is based on current or voltage during a selected charge interval;

determining the charge level of the battery, rate of rise in temperature, baseline temperature of the implantable neuroregulator, type of battery, and a constant or variable rate of charging by the implantable neuroregulator; and

communicating from the implantable neuroregulator to an external charger that the implantable neuroregulator can accept battery charge energy, the level of energy, and the duration of the energy when the baseline temperature and the charge level of the battery are within predefined limits; and

stopping charging when the rate of rise of temperature of the implantable device exceeds the predetermined unsafe rate, wherein the predetermined unsafe rate is 2°

C. per hour or greater or when the temperature of the implantable neuroregulator exceeds a predetermined maximum safe temperature over the baseline temperature.

2. A method of claim 1 further comprising:

receiving the communication at the external charger;

generating the charging energy at the level requested and for the time requested by the implantable neuroregulator, and sending the charging energy to implantable neuroregulator only if requested to do so.

3. A method of claim 2, further comprising:

terminating charging when the implantable neuroregulator communicates that it will not accept charging energy or when the external charger is moved out of range.

4. A method of claim 3, wherein the implantable neuroregulator communicates that it will not accept charge when the battery indicates it is charged or when the temperature exceeds a predetermined maximum safe limit, or when the rate of temperature rise exceeds a predetermined limit.

5. The method of claim 1, wherein the variable rate of charge is selected.