Method and apparatus for regulating blood volume using volume receptor stimulation

• US 8,209,033 B2
• Filed: 05/14/2007
• Issued: 06/26/2012
• Est. Priority Date: 05/14/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Zhang, Yunlong, Bentsen, James G., Dalal, Yousufali
• Primary Examiner(s): Layno, Carl H.
• Assistant Examiner(s): MORALES, JON ERIC C
• Application Number:
  US11/748,171
• Publication Number:
  US 20080288030A1
• Time in Patent Office: 1,870 Days
• Field of Search: 607/59, 607/9, 607/120, 607/115, 607/116, 607/62, 607/48, 607/24
• US Class Current: 607/120
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4869 Determining body composition
• CPC Class Codes: A61B 7/003 Detecting lung or respiration noise
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36528 the parameter being measured by means of ultrasound
• CPC Class Codes: A61N 1/3655 controlled by body or blood temperature
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/36571 controlled by blood flow rate, e.g. blood velocity or cardiac output

Abstract

A system delivers stimulation to volume receptors in the cardiovascular system to induce diuresis in a patient suffering volume overload. The system senses a volume signal indicative of a level of fluid retention in the patient'"'"'s body and controls the delivery of the stimulation using the volume signal. In various embodiments, the stimulation includes one or more of electrical stimulation, which delivers electrical pulses to the volume receptors, and mechanical stimulation, which physically stretches the volume receptors.

Claims

1. A stimulation system for regulating fluid volume in a body having a cardiovascular system including a superior vena cava, an inferior vena cava, a pulmonary vein, a right atrium, and a left atrium by stimulating volume receptors distributed in the cardiovascular system in or near one or more of a junction of the superior vena and the right atrium, a junction of the inferior vena cava and the right atrium, and a junction of the pulmonary vein and the left atrium, the volume receptors being low-pressure baroreceptors sensing blood volume in the body, the system comprising:

a stimulation device configured to deliver stimulation to the volume receptors;

a fluid volume sensor configured to sense a volume signal indicative of a level of fluid retention in the body; and

a stimulation controller coupled to the stimulation device and the fluid volume sensor, the stimulation controller programmed to control the delivery of the stimulation using the volume signal and one or more stimulation parameters selected to induce diuresis while preventing desensitization of the volume receptors.

2. The system of claim 1, comprising a volume overload detector adapted to detect volume overload using the volume signal and a threshold, and wherein the stimulation controller is programmed to initiate the delivery of the stimulation in response to the detection of the volume overload.

3. The system of claim 1, wherein the stimulation controller is programmed to adjust the one or more stimulation parameters using feedback control with the volume signal being an input.

4. The system of claim 1, wherein the stimulation controller comprises a stimulation initiator programmed to initiate the delivery of the stimulation using one or more of the volume signal and a stimulation period.

5. The system of claim 4, wherein the stimulation controller further comprises one or more of a stimulation duration timer and a stimulation duty cycle timer, the stimulation duration timer programmed to time the delivery of stimulation using the stimulation duration following the initiation of the delivery of stimulation, the stimulation duty cycle timer programmed to time a duty cycle during the stimulation duration.

6. The system of claim 1, wherein the stimulation device comprises an electrical stimulation device including

stimulation electrodes configured to deliver electrical stimulation to the volume receptors;

and

a stimulation output circuit configured to deliver the electrical stimulation through the electrodes.

7. The system of claim 6, comprising an implantable medical device including at least the stimulation controller, and wherein the electrical stimulation device is wirelessly coupled to the implantable medical device and comprises a fixation device to stabilize a position of the electrical stimulation device in the cardiovascular system.

8. The system of claim 6, comprising:

an implantable medical device including at least the stimulation controller; and

an implantable transvenous lead including a proximal end, a distal end, and an elongate body between the proximal end and the distal end, the proximal end configured to be connected to the implantable medical device,

wherein at least one of the stimulation electrodes is connected to the distal end, and the implantable transvenous lead is configured to allow intravascular placement of the at least one of the stimulation electrodes.

9. The system of claim 6, comprising:

an implantable medical device including at least the stimulation controller; and

an implantable lead including a proximal end, a distal end, and an elongate body between the proximal end and the distal end, the proximal end configured to be connected to the implantable medical device,

wherein at least one of the stimulation electrodes is connected to the distal end, and wherein the implantable lead is configured to allow the at least one of the stimulation electrodes to be placed on the cardiovascular system over the volume receptors.

10. The system of claim 1, wherein the stimulation device comprises a mechanical stimulation device including:

an adjustable element configured to stretch the volume receptors when being adjusted; and

a mechanical stimulus generator to adjust the adjustable element.

11. The system of claim 10, comprising:

an implantable medical device including at least the stimulation controller and the mechanical stimulus generator; and

an implantable transvenous lead including a proximal end, a distal end, and an elongate body between the proximal end and the distal end, the proximal end configured to be connected to the implantable medical device,

wherein the adjustable element is connected to the distal end, and the implantable transvenous lead is configured to allow intravascular placement of the adjustable element to stretch the volume receptors.

12. The system of claim 1, wherein the fluid volume sensor comprises a chemical sensor configured to sense one or more of blood concentration of atrial naturetic factor (ANF) and blood concentration of brain naturetic factor (BNF).

13. The system of claim 2, wherein the fluid volume sensor comprises a plurality of sensors configured to sense a plurality of signals indicative of the level of fluid retention in the body, and the volume overload detector is configured to detect the volume overload by using the sensed plurality of signals, weighting factors each to be applied to a signal of the sensed plurality of signals, and a threshold.

14. The system of claim 6, wherein the stimulation output circuit is configured to deliver electrical stimulation pulses through the electrodes to the volume receptors, and the stimulation controller is configured to synchronize the delivery of the electrical stimulation pulses to cardiac depolarization.

15. A method for regulating fluid volume in a body having a cardiovascular system including a superior vena cava, an inferior vena cava, a pulmonary vein, a right atrium, and a left atrium, the method comprising:

sensing a volume signal indicative of a level of fluid retention in the body using a fluid volume sensor;

delivering stimulation from a stimulation device to volume receptors distributed in the cardiovascular system in or near one or more of a junction of the superior vena and the right atrium, a junction of the inferior vena cava and the right atrium, and a junction of the pulmonary vein and the left atrium to induce diuresis while preventing desensitization of the volume receptors, the volume receptors being low-pressure baroreceptors sensing blood volume in the body; and

controlling the delivery of the stimulation using the volume signal.

16. The method of claim 15, wherein delivering stimulation from the stimulation device to the volume receptors comprises delivering electrical pulses from an electrical stimulation device to the volume receptors.

17. The method of claim 15, wherein delivering stimulation to the volume receptors comprises mechanically stretching the volume receptors using a mechanical stimulation device.

18. The method of claim 15, comprising detecting an occurrence of volume overload using the volume signal and a threshold, and wherein delivering the stimulation comprises delivering the stimulation in response to the detection of the occurrence of volume overload.

19. The method of claim 18, wherein delivering the stimulation comprises adjusting one or more stimulation parameters using feedback control using the volume signal as an input.

20. The method of claim 15, wherein controlling the delivery of the stimulation comprises initiating the delivery of the stimulation using a stimulation period and the volume signal.

21. The method of claim 20, wherein controlling the delivery of the stimulation comprises timing the delivery of stimulation using a stimulation duration following the initiation of the delivery of stimulation.

22. The method of claim 21, wherein controlling the delivery of the stimulation comprises timing a duty cycle during the stimulation duration.

23. A method for regulating fluid volume in a body having volume receptors in a cardiovascular system, the method comprising:

sensing a plurality of signals each indicative of a level of fluid retention in the body using a fluid volume sensor;

detecting an occurrence of volume overload using the plurality of signals, weighting factors each applied to a signal of the plurality of signals, and a threshold; and

delivering stimulation from a stimulation device to the volume receptors to induce diuresis in response to the detection of the occurrence of volume overload.