METHOD FOR MONITORING A PHYSIOLOGIC PARAMETER OF PATIENTS WITH CONGESTIVE HEART FAILURE

• US 20070032734A1
• Filed: 07/21/2006
• Published: 02/08/2007
• Est. Priority Date: 10/03/2002
• Status: Active Grant

• Current Assignee: UIM Pressure Implant Incorporated
• Original Assignee: Integrated Sensing Systems Incorporated
• Inventors: Najafi, Nader, Rich, Collin
• Granted Patent: US 8,014,865 B2
• Time in Patent Office: Days
• US Class Current: 600/513
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling

Abstract

A method of monitoring physiological parameters for diagnosis and treatment of congestive heart failure in a patient. The method includes implanting at least one sensing device in a cavity of the patient'"'"'s cardiovascular system, preferably so that the sensing device passes through and is anchored to a septum of the heart and, to minimize the risk of thrombogenicity, a larger portion of the sensing device is located in the right side of the heart and a smaller portion of the sensing device is located in the left side of the heart. Electromagnetic telecommunication and/or wireless powering of the sensing device is performed with an external readout device. The method can be used to perform effective monitoring, management, and tailoring of treatments for patients suffering from congestive heart failure, as well as many other diseases.

Claims

1. A method of monitoring one or more physiological parameters for diagnosis of congestive heart failure within a patient, the method comprising:

implanting at least one sensing device in a cavity of the patient'"'"'s cardiovascular system, the sensing device comprising an anchoring mechanism, at least one inductor coil, and at least one sensor operating to sense at least one of the one or more physiological parameters, with optional electronic components, the at least one sensing device being implanted so that a portion of the anchoring mechanism passes through a septum of the heart and, to minimize the risk of thrombogenicity, a larger portion of the sensing device is located in the right side of the heart and a smaller portion of the sensing device is located in the left side of the heart and includes the at least one sensor;

providing a non-implantable readout device that is not implanted in the patient, the readout device comprising at least one inductor coil having telemetric means for at least one of electromagnetic telecommunication and electromagnetic wireless powering of the sensing device through the at least one inductor coil of the sensing device.

2. The method according to claim 1, wherein the at least one sensor of the sensing device comprises at least one capacitive sensor that capacitively senses one or more physiological parameters within the cavity.

3. The method according to claim 1, wherein the sensing device comprises a battery, and the method comprises wirelessly recharging the battery.

4. The method according to claim 1, wherein the one or more physiological parameters include pressure sensed by the at least one sensor.

5. The method according to claim 4, wherein the pressure is chosen from the group consisting of left ventricular end diastolic pressure, left atrium pressure, left atrium appendage pressure, mean left atrium pressure, pressure within the left side of the heart, pressure within the right side of the heart, right atrium pressure, mean right atrium pressure, right ventricular end diastolic pressure, and differential pressure between the left and right atrium.

6. The method according to claim 4, further comprising the step of calculating changes in the pressure over time (dp/dt).

7. The method according to claim 1, wherein the sensing device sends data directly to a drug delivery device to tailor drug treatment of the patient.

8. The method according to claim 1, wherein a resonant scheme is used to couple the sensing device to the readout device.

9. The method according to claim 1, wherein a passive scheme is used to couple the sensing device to the readout device.

10. The method according to claim 1, wherein an active scheme is used to couple the sensing device to the readout device.

11. The method according to claim 1, wherein the at least one physiologic parameter sensed by the at least one sensor is chosen from the group consisting of pressure, temperature, flow, blood composition, blood gas content, chemical composition, acceleration, and vibration.

12. The method according to claim 1, wherein the at least one sensing device is implanted in the atrial septum.

13. The method according to claim 1, wherein the at least one sensing device is implanted in the ventricular septum.

14. The method according to claim 1, wherein the method is part of in at least one of the following procedures:

early diagnosis of a heart failing due to congestive heart failure related conditions;

early intervention in treatment of congestive heart failure related conditions;

tailoring of medications;

disease management;

identification of complications from congestive heart failure related conditions;

identification of complications from cardiovascular disease related conditions;

treatment of complications from congestive heart failure related conditions;

treatment of complications from cardiovascular disease related conditions;

feedback regarding the impact of medication on the heart;

pacing adjustments;

reduction in frequency and severity of hospitalizations due to cardiovascular diseases;

reduction in frequency and severity of hospitalizations due to congestive heart failure;

tuning of defibrillator or pacemaker parameters to improve congestive heart failure related conditions;

identification of mitral valve stenosis; and

treatment of mitral valve stenosis.

15. The method according to claim 1, wherein the readout device is used to perform at least one of the following:

remote monitoring of congestive heart failure patients;

monitoring of congestive heart failure patients with telephone-based (or similar method) data and information delivery;

monitoring of congestive heart failure patients with wireless telephone-based data and information delivery;

monitoring of congestive heart failure patients with web-based data and information delivery;

closed-loop drug delivery to treat congestive heart failure;

closed-loop pacemaker parameter tuning to treat congestive heart failure or congestive heart failure related conditions;

warning systems for critical worsening of congestive heart failure or congestive heart failure related conditions;

portable or ambulatory monitoring or diagnosis;

battery-operation capability;

data storage;

reporting global positioning coordinates for emergency applications;

communication with other medical devices chosen from the group consisting of pacemakers, defibrillators cardioverter defibrillators drug delivery systems, non-drug delivery systems, and wireless medical management systems.

16. The method according to claim 1, wherein the at least one sensing device and the readout device are incorporated into a closed-loop system with a left atrium to right atrium unidirectional valve for preventing the development of pulmonary edema.

17. The method according to claim 1, wherein the at least one sensor comprises a barometric pressure sensor.

18. The method according to claim 17, wherein the barometric pressure sensor operates to compensate for variations in atmospheric pressure.

19. The method according to claim 1, wherein the sensing device is implanted using a minimally invasive outpatient technique.

20. The method according to claim 1, wherein the sensing device is implanted using a catheter delivery method.

21. The method according to claim 1, wherein the anchoring mechanism is chosen from the group consisting of:

anchoring mechanisms for septal occluder devices, anchoring mechanisms for left atrial appendage occluders, anchoring mechanisms for cardiac pacing leads, screws, tines, and stents.

22. The method according to claim 21, wherein the anchoring mechanism comprises means opening on at least one side of the septal wall and clamping the device to the septal wall.

23. The method according to claim 22, wherein the portion of the anchoring mechanism passes through the atrial septum of the heart.

24. The method according to claim 23, wherein the anchoring mechanism comprises two umbrella-shaped anchors disposed on opposite sides of the atrial septum.

25. The method according to claim 1, wherein the anchoring mechanism is a helical screw.

26. The method according to claim 1, wherein the anchoring mechanism is a tine catching on a trabeculated area of the heart.

27. The method according to claim 1, wherein the at least one sensing device and the readout device are part of a closed-loop pacing/ICD (cardioverter defibrillator) tuning system wherein data from the at least one sensing device is sent to a patient pacemaker for tailoring function of a pacing/ICD unit.

28. The method according to claim 27, wherein the at least one sensing device is directly interrogated by the pacing/ICD unit.

29. The method according to claim 27, wherein the at least one sensing device is interrogated by the pacing/ICD unit, and the method further comprises using an external unit for transmitting power to the at least one sensing device.

30. The method according to claim 27, wherein the at least one sensing device transmits data to the readout device, and the readout device retransmits the data to the pacing/ICD unit.

31. The method according to claim 30, wherein the readout device and the pacing/ICD unit perform at least one function of interrogation or powering of the at least one sensing device.