Obesity therapy and heart rate variability

• US 8,696,616 B2
• Filed: 12/29/2010
• Issued: 04/15/2014
• Est. Priority Date: 12/29/2010
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Baynham, Tamara C., Harris, Jason L.
• Primary Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US12/980,695
• Publication Number:
  US 20120172792A1
• Time in Patent Office: 1,203 Days
• Field of Search: 604/66, 604/503, 607/2, 607/40, 607/58, 607/60, 600/509
• US Class Current: 604/65
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/33 specially adapted for cooperation with other devices
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/36153 Voltage A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient

Abstract

Methods and devices are provided for delivering obesity therapy to a patient. In general, the methods and devices allow for onset of a patient eating solid food, e.g., the patient beginning a meal, to trigger delivery of an obesity therapy to a patient. The obesity therapy can be delivered to the patient for a limited period of time such that the patient stops receiving the obesity therapy prior to a second onset of the patient eating solid food, e.g., the patient beginning a second meal, which can trigger a second delivery of the obesity therapy to the patient for a limited period of time.

Claims

1. A medical system, comprising:

a sensor configured to be positioned in contact with a tissue of a patient, the sensor being configured to sense a heart rate of the patient;

a processor configured to be in communication with the sensor and to analyze the sensed heart rate to detect a change in heart rate of the patient by analyzing electrocardiogram (ECG) signals sensed by the sensor, the analyzing comprising analyzing a power spectral density in low frequency and high frequency bands such that the processor determines onset of the patient eating a solid food; and

a delivery device configured to be implanted within the patient and to be in communication with the processor, the delivery device being defaulted to a dormant mode in which the delivery device does not deliver an obesity therapy to the patient, and the delivery device being configured to change from the dormant mode to a delivery mode, in which the delivery device delivers the obesity therapy to the patient, in response to the processor detecting the change in heart rate and determining the onset of the patient eating the solid food.

2. The system of claim 1, wherein the delivery device is configured to change from the delivery mode to the dormant mode upon occurrence of a predetermined trigger event, and is configured to repeatedly change between the delivery and dormant modes based on the processor detecting changes in heart rate of the patient and determining the onset of the patient eating a solid food, and based on occurrences of the predetermined trigger event.

3. The system of claim 2, wherein the predetermined trigger event comprises passage of a predetermined amount of time during which the delivery device is in the delivery mode.

4. The system of claim 1, wherein the processor is configured to be implanted within the patient.

5. The system of claim 1, wherein the processor is configured to be transcutaneously positioned.

6. The system of claim 1, wherein the sensor is configured to be implanted within the patient.

7. The system of claim 6, wherein the sensor comprises at least one of a lead configured to be implanted within a heart of the patient, and an electrode configured to be implanted on a thorax of the patient.

8. The system of claim 1, wherein the sensor is configured to be transcutaneously positioned such that the sensor is in direct contact with an exterior skin surface of the patient.

9. The system of claim 8, wherein the sensor comprises at least one of a first electrode attached to a strap configured to be worn by the patient such that the first electrode is positioned on an exterior skin surface of a chest of the patient, a second electrode attached to an article of clothing configured to be worn by the patient such that the second electrode contacts an exterior skin surface of the patient, a pulse oximeter configured to be positioned on an external skin surface of a finger of the patient, and a third electrode attached to a band configured to be positioned around a wrist of the patient such that the third electrode contacts an exterior skin surface of a wrist of the patient.

10. The system of claim 1, wherein the obesity therapy comprises at least one of electrical stimulation and administration of a therapeutic agent to the patient.

11. The system of claim 10, wherein the therapeutic agent comprises a nutrient configured to provoke a release of one or more hormones from L-cells of the patient.

12. The system of claim 1, wherein the processor is configured to transmit data indicating an amount of the solid food eaten by the patient to the delivery device, the delivery device being configured to determine an amount of the obesity therapy to deliver to the patient based on the transmitted data.

13. A medical method, comprising:

positioning a sensing device in contact with tissue of a patient;

positioning a delivery device in contact with tissue of the patient, the delivery device including an obesity therapy and being in a default off configuration in which the delivery device does not deliver the obesity therapy to the patient;

detecting a change in heart rate of a patient using heart rate data gathered by the sensing device by analyzing a power spectral density in low frequency and high frequency bands of the heart rate data to determine onset of the patient eating a solid food; and

in response to the determined onset of the patient eating the solid food and the detected change in heart rate, changing the delivery device from the default off configuration to an on configuration in which the delivery device delivers the obesity therapy to the patient.

14. The method of claim 13, further comprising:

detecting the onset of the patient eating the solid food and the change in heart rate using a processor remotely located from the delivery device; and

transmitting the change in heart rate from the processor to the delivery device to trigger the changing.

15. The method of claim 13, wherein positioning the sensing device comprises transdermally positioning the sensing device such that the sensing device is in direct contact with an exterior skin surface of the patient.

16. The method of claim 13, wherein positioning the sensing device comprises implanting the sensing device within the patient.

17. The method of claim 13, wherein delivering the obesity therapy comprises at least one of electrically stimulating the patient and administering a therapeutic agent to the patient.

18. The method of claim 13, further comprising orally administering a nutrient to the patient in conjunction with the patient eating solid food, and wherein the obesity therapy comprises electrically stimulating the patient.

19. The method of claim 13, further comprising changing the delivery device from the on configuration to the off configuration after a predetermined amount of time has passed after the determined onset of the patient eating the solid food and the detected change in heart rate.

20. The method of claim 13, further comprising determining that the patient has ceased eating the solid food, and changing the delivery device from the on configuration to the off configuration in response to the determination that the patient has ceased eating the solid food.

21. The method of claim 13, further comprising determining subsequent onsets of the patient eating solid food, wherein the delivery device is only changed from the default off configuration to the on configuration in response to the determined onset of the patient eating the solid food and in response to the subsequent determinations of onsets of the patient eating solid food.