Method and apparatus for control of cardiac therapy using non-invasive hemodynamic sensor

• US 8,798,747 B2
• Filed: 10/13/2011
• Issued: 08/05/2014
• Est. Priority Date: 12/22/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kramer, Andrew P., Pastore, Joseph M., Stahmann, Jeffrey E., Salo, Rodney W., Hartley, Jesse W.
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US13/273,108
• Publication Number:
  US 20120029588A1
• Time in Patent Office: 1,027 Days
• Field of Search: 600/483, 600500-503, 607 17- 18, 607 22- 23
• US Class Current: 607/17
• CPC Class Codes: A61B 5/6816 Ear lobe
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36564 controlled by blood pressure

Abstract

A cardiac rhythm management (CRM) system includes a non-invasive hemodynamic sensing device and an implantable medical device to sense a hemodynamic signal and derive one or more cardiac performance parameters from the hemodynamic signal. The non-invasive hemodynamic sensing device includes at least a portion configured for external attachment to a body in which the implantable medical device is implanted. The one or more cardiac performance parameters are used for various diagnostic, monitoring, and therapy control purposes.

Claims

1. A system adapted to be coupled to a body having external appendages including a finger, a toe, an ear, an arm, and a wrist, the system comprising:

a non-invasive hemodynamic sensing device including at least a portion configured to be attached to one of the external appendages, the non-invasive hemodynamic sensing device configured to sense a hemodynamic signal indicative of at least a heart rate, produce hemodynamic data associated with the hemodynamic signal, and transmit the hemodynamic data; and

an implantable medical device configured to be communicatively coupled to the non-invasive hemodynamic sensing device via a wireless communication link to receive the hemodynamic data, the implantable medical device including;

a neural stimulation circuit configured to deliver neural stimulation pulses; and

a neural stimulation controller configured to control the delivery of the neural stimulation pulses using one or more neural stimulation parameters tier treating a cardiovascular disorder, the neural stimulation controller including a stimulation parameter adjustment module configured to adjust the one or more neural stimulation parameters using one or more cardiac performance parameters, the stimulation parameter adjustment module configured to compare a heart rate parameter representative of the heart rate to a predetermined threshold heart rate and adjust the delivery of the neural stimulation pulses using an outcome of the comparison,

wherein one of the non-invasive hemodynamic sensing device and the implantable medical device includes a parameter generator configured to produce the one or more cardiac performance parameters including the heart rate parameter using the hemodynamic data.

2. The system of claim 1, wherein the stimulation parameter adjustment module is configured to set the one or more neural stimulation parameters to prevent ventricular remodeling.

3. The system of claim 1, wherein the stimulation parameter adjustment module is configured to set the one or more neural stimulation parameters to decrease blood pressure.

4. The system of claim 3, wherein the non-invasive hemodynamic sensing device comprises a cuff sensor configured for attachment to the arm or the wrist to sense a peripheral blood pressure signal.

5. The system of claim 1, wherein the parameter generator is further configured to produce a pulse pressure parameter of the one or more cardiac performance parameters, the pulse pressure parameter representative of a pulse pressure, and the stimulation parameter adjustment module is configured to compare the pulse pressure parameter to a predetermined threshold pulse pressure and adjust the delivery of the neural stimulation pulses using an outcome of the comparison of the pulse pressure parameter to the predetermined threshold pulse pressure.

6. The system of claim 5, wherein the stimulation parameter adjustment module comprises a pulse comparator configured to compare the pulse pressure parameter to the predetermined threshold pulse pressure, and the neural stimulation switch is further configured to stop the delivery of the neural stimulation pulses in response to the pulse pressure parameter dropping below the predetermined threshold pulse pressure.

7. The system of claim 1, wherein the stimulation parameter adjustment module comprises a heart rate comparator configured to compare the heart rate parameter representative of the heart rate to the predetermined threshold heart rate and a neural stimulation switch configured to stop the delivery of the neural stimulation pulses in response to the heart rate parameter being below the predetermined threshold heart rate.

8. The system of claim 7, wherein the neural stimulation switch is configured to stop the delivery of the neural stimulation pulses in response to the heart rate parameter dropping below a first predetermined threshold heart rate and start the delivery of the neural stimulation pulses in response to the heart rate rising above a second predetermined threshold heart rate.

9. The system of claim 1, wherein the non-invasive hemodynamic sensing device comprises a clip sensor configured for attachment to the finger, the toe, or the ear.

10. The system of claim 9, wherein the non-invasive hemodynamic sensing device comprises a portable repeater coupled to the clip sense sensor, the portable repeater configured to transmit the hemodynamic data to the implantable medical device via the wireless communication link.

11. A method for delivering electrical stimulation to a patient, the method comprising:

sensing a hemodynamic signal indicative of at least a heart rate using a non-invasive hemodynamic sensing device;

producing hemodynamic data associated with the hemodynamic signal;

transmitting the hemodynamic data to an implantable medical device through a wireless communication link;

producing one or more cardiac performance parameters including a heart rate parameter representative of the heart rate using the hemodynamic data using one of the non-invasive hemodynamic sensing device and the implantable medical device;

adjusting one or more neural stimulation parameters using the one or more cardiac performance parameters using a stimulation controller of the implantable medical device;

controlling delivery of neural stimulation pulses using the one or more stimulation parameters, including comparing the heart rate parameter representative to a predetermined threshold heart rate and adjusting the delivery of the neural stimulation pulses using an outcome of the comparison; and

delivering the neural stimulation pulses from the implantable medical device.

12. The method of claim 11, wherein delivering the neural stimulation pulses comprises delivering the neural stimulation pulses to a vagus nerve.

13. The method of claim 12, wherein controlling the delivery of the neural stimulation pulses comprises setting the one or more neural stimulation parameters to prevent ventricular remodeling.

14. The method of claim 12, wherein controlling the delivery of the neural stimulation pulses comprises setting the one or more neural stimulation parameters to decrease blood pressure.

15. The method of claim 11, wherein producing the one or more cardiac performance parameters further comprises producing a pulse pressure parameter representative of a pulse pressure, and controlling the delivery of the neural stimulation pulses comprises comparing the pulse pressure parameter to a predetermined threshold pulse pressure and adjusting the delivery of the neural stimulation pulses using an outcome of the comparison of the pulse pressure parameter to the predetermined threshold pulse pressure.

16. The method of claim 15, wherein controlling the delivering of the neural stimulation pulses comprises stopping the delivery of the neural stimulation pulses in response to the pulse pressure parameter dropping below the predetermined threshold pulse pressure.

17. The method of claim 11, wherein controlling the delivery of the neural stimulation pulses comprises stopping the delivery of the neural stimulation pulses in response to the heart rate parameter being below the predetermined threshold heart rate.

18. The method of claim 17, wherein controlling the delivery of the neural stimulation pulses further comprises stopping the delivery of the neural stimulation pulses in response to the heart rate parameter dropping below a first predetermined threshold heart rate and starting the delivery of the neural stimulation pulses in response to the heart rate rising above a second predetermined threshold heart rate.

19. The method of claim 11, comprising sensing the hemodynamic signal when the noninvasive hemodynamic sensing device is attached to the patient'"'"'s finger, toe, ear, arm, or wrist.

20. The method of claim 19, further comprising controlling the delivery of the neural stimulation pulses for delivering the neural stimulation pulses when the one or more cardiac performance parameters indicate that the patient'"'"'s cardiac output is at a tolerable level.