Cardiac rhythm management device and sensor-suite for the optimal control of ultrafiltration and renal replacement therapies

• US 8,246,563 B2
• Filed: 02/02/2006
• Issued: 08/21/2012
• Est. Priority Date: 02/02/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Wariar, Ramesh
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Wiest, Philip R
• Application Number:
  US11/345,702
• Publication Number:
  US 20070175827A1
• Time in Patent Office: 2,392 Days
• Field of Search: 604 401- 616, 604 19- 21, 422 44- 48, 607/44, 607/60, 210/650, 210134-143, 600/315
• US Class Current: 604/4.01
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/6866 Extracorporeal blood circuits, e.g. dialysis circuits
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1611 Weight of the patient
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 2230/208 pH-value
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61N 1/37282 : characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A cardiorenal patient monitoring system comprising, either implanted or non-implanted device(s), remote peripheral device(s), computer network(s), host, and communication means between the device(s), computer network(s), and host. The preferred embodiment shows an advanced patient monitoring system for using an implanted cardiac device and a dialysis machine in renal therapy. In addition, the method of advanced patient monitoring is in conjunction with the advanced patient monitoring system is disclosed.

Claims

1. An integrated cardiorenal disease therapy management system, comprising:

a. a renal therapy device including at least one of an external dialysis device or an external ultrafiltration device configured to provide renal therapy to a subject;

b. an implantable cardiac rhythm management device including;

a sensor for measuring data representative of a patient physiological parameter; and

a cardiac rhythm management therapy circuit configured to provide cardiac rhythm management therapy to the subject; and

c. a control system coupled to the renal therapy device and configured to receive the data representative of the patient physiological parameter, wherein the control system directs therapy provided by the renal therapy device using information from the data representative of the patient physiological parameter received from the implantable cardiac rhythm management device when the implantable cardiac rhythm management device has been implanted in the subject.

2. The cardiorenal disease therapy management system of claim 1 wherein the control system directs therapy, provided by the renal therapy device, using information from the data representative of the patient physiological parameter received from the implantable cardiac rhythm management device when the implantable cardiac rhythm management device has been implanted in the subject, by modifying at least one of the following:

flow of blood through the renal therapy device, flow of dialysate or ultrafiltrate through the renal therapy device, flow of a medication or saline into the renal therapy device, ionic composition of dialysate fluid flowing into the renal therapy device, or temperature of blood or dialysate in the renal therapy device.

3. The cardiorenal disease therapy management system of claim 1 wherein the renal therapy device is a dialysis therapy device.

4. The cardiorenal disease therapy management system of claim 1 wherein the renal therapy device is an ultrafiltration therapy device.

5. The cardiorenal disease therapy management system of claim 1 wherein the patient physiological parameter comprises data representative of at least one of the following:

heart rate, heart rate variability, electrogram, autonomic balance, heart vibrations, thoracic impedance, thoracic fluid status, intracardiac pressure, cardiac oxygenation, patient activity level, patient temperature, blood pressure, breathing pattern, blood chemistry, pH, blood conductivity, blood flow, blood oxygenation, cardiac volume, cardiac output, ejection fraction, or stroke volume.

6. The cardiorenal disease therapy management system of claim 1 wherein the control system directs therapy by modifying flow of a medication or saline into the renal therapy device.

7. The cardiorenal disease therapy management system of claim 1 wherein the control system directs therapy by modifying an ionic composition of dialysate fluid flowing into the renal therapy device.

8. The cardiorenal disease therapy management system of claim 1 wherein the control system directs therapy by modifying a temperature of blood or dialysate in the renal therapy device.

9. The cardiorenal disease therapy management system of claim 1 wherein the patient physiological parameter comprises data representative of autonomic balance.

10. The cardiorenal disease therapy management system of claim 1 wherein the patient physiological parameter comprises data representative of patient activity level.

11. The cardiorenal disease therapy management system of claim 1 wherein the patient physiological parameter comprises data representative of patient temperature.

12. The cardiorenal disease therapy management system of claim 1 wherein the patient physiological parameter comprises data representative of a breathing pattern.

13. The cardiorenal disease therapy management system of claim 1 wherein the patient physiological parameter comprises data representative of blood chemistry.

14. The cardiorenal disease therapy management system of claim 1, wherein the control system is configured to provide an alarm indication when the patient physiological parameter exceeds a specified threshold.

15. A method of controlling renal therapy delivered to a patient from an external renal therapy device, the method comprising:

a. transmitting data representative of a patient physiological parameter from at least one sensor of a cardiac rhythm management device implanted in the patient and configured to provide cardiac rhythm management therapy comprising at least one of pacing, anti-tachyarrhythmia, or cardiac resynchronization therapy to the patient;

b. processing the data; and

c. modifying the renal therapy delivered to the patient using information from the data representative of the patient physiological parameter received from the cardiac rhythm management device implanted within the patient and configured to provide the cardiac rhythm management therapy to the patient.

16. The method of claim 15 wherein the renal therapy comprises ultrafiltration and the renal therapy device comprises an ultrafiltration device.

17. The method of claim 16 including trending the patient physiological parameter to determine a cardiovascular performance change in relation to an ultrafiltration rate, wherein the data representative of the patient physiological parameter includes at least one of thoracic fluid status, cardiac volume, blood conductivity, or heart rate variability received from the cardiac rhythm management device implanted within the patient and configured to provide the cardiac rhythm management therapy to the patient.

18. The method of claim 15 wherein the processing further comprises processing data representative of a blood pressure of the patient, and wherein the modifying further comprises modifying a rate at which blood is removed from the patient'"'"'s body in response to the data representative of the blood pressure of the patient, received from the cardiac rhythm management device implanted within the patient and configured to provide the cardiac rhythm management therapy to the patient.

19. The method of claim 15 wherein the processing further comprises processing data representative of a transthoracic impedance of the patient, wherein the data representative of the transthoracic impedance of the patient includes an indication of the patient'"'"'s thoracic fluid status, and wherein the modifying further comprises modifying fluid removal from the patient'"'"'s body in response to the data representative of the transthoracic impedance of the patient received from the cardiac rhythm management device implanted within the patient and configured to provide the cardiac rhythm management therapy to the patient.

20. The method of claim 15 further including measuring a fluid volume within the patient using the implanted cardiac rhythm management device and transmitting from the implanted cardiac rhythm management device data representative of the fluid volume to control in real-time the renal therapy the patient receives.

21. The method of claim 15, wherein the renal therapy comprises at least one of the following therapies:

dialysis therapy or ultrafiltration therapy.

22. A renal disease therapy management system, comprising:

a. a renal therapy device including at least one of an external dialysis device or an external ultrafiltration device configured to provide renal therapy to a subject;

b. an implantable cardiac rhythm management device including;

a sensor for data representative of a patient physiological parameter; and

a cardiac rhythm management therapy circuit configured to provide cardiac rhythm management therapy to the subject;

c. a control system coupled to the renal therapy device and configured to receive the data representative of the patient physiological parameter, wherein the control system directs therapy provided by the renal therapy device using information from the data representative of the patient physiological parameter received from the implantable cardiac rhythm management device when the implantable cardiac rhythm management device has been implanted in the subject; and

d. a health management host system coupled to the renal therapy device and the implantable cardiac rhythm management device in a manner that allows data transmission between the implantable cardiac rhythm management device and the renal therapy device when the implantable cardiac rhythm management device has been implanted in the subject.

23. The renal disease therapy management system of claim 22, wherein the health management host system is configured to analyze and display renal therapy data and data representative of a patient physiological parameter on a health management display.

24. The renal disease therapy management system of claim 23, wherein the patient physiological data includes fluid retention data.

25. The renal disease therapy management system of claim 23, wherein the renal therapy device is configured with a display device to illustrate a renal therapy strategy.

26. The renal disease therapy management system of claim 22, wherein the renal therapy device comprises a dialysis machine.

27. The renal disease therapy management system of claim 22, wherein the renal therapy device comprises an ultrafiltration machine.