Devices and methods for treatment of heart failure and associated conditions

• US 8,948,874 B2
• Filed: 12/27/2013
• Issued: 02/03/2015
• Est. Priority Date: 06/16/2008
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Georgakopoulos, Dimitrios, Lovett, Eric Grant
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US14/142,274
• Publication Number:
  US 20140163649A1
• Time in Patent Office: 403 Days
• Field of Search: 607/44
• US Class Current: 607/44
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: F01K 25/005 the working fluid being steam, created by combustion of hydrogen with oxygen
• CPC Class Codes: F02C 3/22 the fuel or oxidant being gaseous at standard temperature and pressure F02C3/28 takes precedence
• CPC Class Codes: F02C 3/30 Adding water, steam or other fluids for influencing combustion, e.g. to obtain cleaner exhaust gases F02C7/141, F02C7/30, F01D21/00, F01K21/04, F23D11/10 take precedence
• CPC Class Codes: F05D 2220/31 in steam turbines

Abstract

Devices and methods of use are described for identification, treatment, and/or management of heart failure and/or associated conditions. An exemplary device may include a first fluid status monitoring circuit configured to monitor a first fluid status indicator of a pulmonary fluid status associated with pulmonary edema, a second fluid status monitoring circuit configured to monitor a separate and different second fluid status indicator of a non-pulmonary fluid status, and a controller coupled to the first and second fluid status monitoring circuits, and a therapy circuit coupled to the controller. The controller is configured to use information about the first and second fluid status indicators to determine a therapy control signal to control a therapy, and the therapy circuit is configured to provide therapy in response to the therapy control signal to adjust at least one of the pulmonary fluid status or the non-pulmonary fluid status.

Claims

1. A medical device comprising:

a first fluid status monitoring circuit configured to monitor a first fluid status indicator of a pulmonary fluid in a patient associated with pulmonary edema, wherein an increase in the first fluid status indicator correlates to an increase in pulmonary fluid associated with pulmonary edema;

a second fluid status monitoring circuit configured to monitor a separate and different second fluid status indicator of a non-pulmonary fluid, wherein an increase in the second fluid status indicator correlates to an increase in the non-pulmonary fluid;

a controller coupled to the first and second fluid status monitoring circuits, the controller configured to use information about the first and second fluid status indicators to generate a therapy control signal; and

a therapy circuit coupled to the controller to receive the therapy control signal, the therapy circuit configured to deliver therapy to the patient in response to the therapy control signal to adjust at least one of the pulmonary fluid or the non-pulmonary fluid, wherein the second fluid status indicator comprises a splanchnic measurement representative of fluid associated with a splanchnic organ.

2. The device of claim 1, wherein the controller is configured to trigger providing the therapy in response to at least one of a decrease in the second fluid status indicator below a specified threshold value, an increase in the first fluid status indicator above a specified threshold value, a heart failure decompensation alert provided by the medical device, a patient-initiated alert, or a user input.

3. The device of claim 1, wherein the therapy circuit includes a baroreflex circuit configured to provide a baroreflex therapy to adjust the non-pulmonary fluid, and wherein the baroreflex therapy includes stimulation or inhibition of at least one of a sympathetic nervous system or a parasympathetic nervous system.

4. The device of claim 1, wherein the controller is configured to decrease or stop therapy in response to at least one of:

an increase or decrease in the first fluid status indicator beyond a first specified threshold value;

or

an increase or decrease in the second fluid status indicator beyond a second specified threshold value.

5. The device of claim 1, wherein the controller is configured to use information about the first and second fluid status indicators to stop therapy after a specified period of time.

6. The device of claim 1, comprising a posture sensing circuit configured to detect a posture of a subject, and wherein the controller is configured to use (1) information about the first and second fluid status indicators, and (2) information about the posture of the subject to determine the therapy control signal to control the therapy.

7. The medical device of claim 1, wherein the controller is configured to generate a therapy control signal to cause a decrease in pulmonary fluid and an increase in the non-pulmonary fluid associated with a splanchnic organ.

8. A method comprising:

monitoring a first fluid status indicator of a pulmonary fluid in a patient associated with pulmonary edema;

monitoring a separate and different second fluid status indicator of a non-pulmonary fluid, wherein the second fluid status indicator comprises a splanchnic measurement representative of fluid associated with a splanchnic organ; and

using information about the first and second fluid status indicators, controlling a therapy delivered to the patient to adjust at least one of the pulmonary fluid or the fluid associated with a splanchnic organ.

9. The method of claim 8, wherein the controlling the therapy comprises triggering providing the therapy by a decrease in the second fluid status indicator below a specified threshold value.

10. The method of claim 8, wherein the controlling the therapy includes decreasing or stopping therapy in response to at least one of:

an increase or decrease in the first fluid status indicator beyond a first specified threshold value;

an increase or decrease in the second fluid status indicator beyond a second specified threshold value.

11. The method of claim 8, wherein the controlling the therapy includes using information about the first and second fluid status indicators to stop therapy after a specified period of time.

12. The method of claim 8, wherein the controlling the therapy includes synchronizing delivery of the therapy with a specified portion of the subject'"'"'s cardiac cycle.

13. The method of claim 8, comprising detecting a patient posture, and wherein the controlling the therapy comprises using (1) information about the first and second fluid status indicators, and (2) information about the patient posture to adjust at least one of the pulmonary fluid or the non-pulmonary fluid.

14. The method of claim 8, wherein the therapy is configured to cause a decrease in pulmonary fluid and an increase in the non-pulmonary fluid associated with a splanchnic organ.

15. A non-transitory device-readable medium comprising instructions that when performed by a medical device implanted in a patient, cause the device to perform acts comprising:

monitoring a first fluid status indicator of a pulmonary fluid in the patient status associated with pulmonary edema;

monitoring a separate and different second fluid status indicator of a non-pulmonary fluid, wherein the second fluid status indicator comprises a splanchnic measurement representative of fluid associated with a splanchnic organ; and

using information about the first and second fluid status indicators, providing a control signal to deliver a therapy to the patient to adjust at least one of the pulmonary fluid or the non-pulmonary fluid.

16. The non-transitory device-readable medium of claim 15, wherein the providing the control signal to control the therapy includes providing a control signal to decrease or stop therapy in response to at least one of:

an increase or decrease in the first fluid status indicator beyond a first specified threshold value;

an increase or decrease in the second fluid status indicator beyond a second specified threshold value.

17. The non-transitory device-readable medium of claim 15, wherein the providing the control signal to control the therapy includes providing a control signal to synchronize delivery of the therapy with a specified portion of the subject'"'"'s cardiac cycle.

18. The non-transitory device-readable medium of claim 15, comprising instructions that, when performed by the previously-implanted medical device, cause the device to perform acts comprising detecting a patient posture, and wherein the providing the control signal to control the therapy comprises using (1) information about the first and second fluid status indicators, and (2) information about the patient posture to adjust at least one of the pulmonary fluid or the non-pulmonary fluid.

19. The non-transitory device-readable medium of claim 15, wherein the therapy is configured to cause a decrease in pulmonary fluid and an increase in the non-pulmonary fluid associated with a splanchnic organ.