Remote monitoring and control of implantable devices

• US 8,068,918 B2
• Filed: 03/09/2007
• Issued: 11/29/2011
• Est. Priority Date: 03/09/2007
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: EnteroMedics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Donders, Adrianus P., Ramadhyani, Satish, Chan, Hang, Wang, Wu, Vallapureddy, Vineel
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US11/716,353
• Publication Number:
  US 20080221644A1
• Time in Patent Office: 1,726 Days
• Field of Search: 607/1, 607 59- 60, 607/116, 128/920
• US Class Current: 607/60
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y10S 128/92 Computer assisted medical diagnostics

Abstract

A treatment system includes a regulator implanted within a patient, a computing device storing at least one patient database associated with the patient in whom the regulator is implanted, and a data transfer device. The data transfer device provides bidirectional communication (e.g., voice communication) and a data exchange (e.g., a treatment history, a patient database, and operational instructions) between the regulator and the computing device. A programmer can obtain patient reports and/or default treatment values from the computing device based on the data exchange.

Claims

1. A treatment system comprising:

a regulator adapted to be implanted within a patient, the regulator configured to apply a treatment to the patient, the regulator having a memory configured to store treatment events;

a computing device remote from the regulator, the computing device comprising a receiver module for receiving treatment events from each patient;

a storage module comprising at least one database for storing treatment events from each patient in a database corresponding to each patient, an evaluate module for comparing the treatment events of a first patient with the treatment events of at least one other patient in order to determine which patients are similar to one another to form a subset of patients with similar treatment events, and determining treatment values corresponding with successful treatment in the subset of patients;

a controller configured to control operation of the regulator and adapted for placement on the patient, the controller including a memory and a transmission coil, the memory of the controller being configured to store treatment events, the transmission coil of the controller being configured to communicate with the regulator and with a data transfer device;

wherein the data transfer device communicates with the regulator through the controller;

a data transfer device comprising memory and a transmission unit configured to communicate with the controller and configured to communicate with the computing device over a network to transfer the treatment events from the memory of the controller to the computing device for storage in the patient database;

a report module for generating at least one report for each patient based on the treatment events and configured to receive treatment events from the computing device, wherein the at least one report comprises a patient use report indicating whether the patient operated the regulator correctly over a period of time; and

a programmer configured to be operated by a clinician at a location remote from the patient, wherein the programmer is configured to determine whether the programmer has a current treatment history of the patient; and

wherein the programmer is configured to communicatively couple to the remote computing device to obtain the current treatment history of the patient if the programmer determines the programmer does not have the current treatment history, and configured to display at least one report generated by the report module.

2. The treatment system of claim 1, wherein the programmer is configured to communicatively couple to the data transfer device over a wireless network.

3. The treatment system of claim 2, wherein the programmer is configured to communicate with the data transfer device via a cellular network.

4. A method of programming a treatment system of claim 1 comprising:

receiving at the computing device of the treatment system of claim 1 a plurality of treatment events from a plurality of patient regulators, each patient regulator being associated with a patient;

storing the treatment events for each patient in at least one patient database on the computing device to form a plurality of patient databases, each patient database being associated with one of the patients;

evaluating the plurality of patient databases stored on the computing device to determine which patient databases are associated with patients similar to the first patient to form a subset of patients;

determining treatment values corresponding with successful treatment in the subset of patients similar to the first patient;

receiving a request for treatment values for the first patient from the programmer of the treatment system of claim 1 and determining that the first patient is a member of the subset of patients; and

transmitting the determined treatment values of the subset of patients from the computing device to the programmer in response to the request for treatment values for the first patient from the programmer.

5. The method of claim 4, wherein the treatment values are selected from the group consisting of amplitude of regulator signal, frequency of the regulator signal, pulse width, ramp up time, ramp down time, on time, off time, lead configuration and combinations thereof.

6. The method of claim 4, wherein the treatment values comprise duration of therapy cycles, timing of treatment cycles, and combinations thereof.

7. A method of operating a treatment system of claim 1 comprising:

sending a request for treatment events for a patient from the programmer or the computing device;

receiving a request for treatment events for the patient at the data transfer device;

sending a request for treatment events for the patient from the data transfer device to the controller of the system of claim 1 in order to obtain treatment events of the patient from the controller;

receiving treatment events of the patient at the data transfer device from the controller;

transmitting the obtained treatment events from the data transfer device to the computing device, the obtained treatment events being stored in a patient database at the computing device;

processing the obtained treatment events on the computing device;

downloading the patient database from the computing device to the programmer;

generating at least one patient report based on the obtained treatment events, wherein generating at least one patient report comprises generating a patient use report indicating whether the patient operated the regulator correctly over a select period of time;

communicating the at least one patient report to the programmer; and

displaying the patient report on the programmer.

8. The method of claim 7, wherein generating at least one patient report comprises generating a therapy delivery report indicating whether treatment was provided to the patient at scheduled time intervals over a select period of time.

9. The method of claim 7, further comprising sending modified treatment values based on the patient use report from the programmer to the data transfer device, and communicating the modified treatment values to the controller.