Method for monitoring a physiologic parameter of patients with congestive heart failure

• US 8,014,865 B2
• Filed: 07/21/2006
• Issued: 09/06/2011
• 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 A.
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US11/459,065
• Publication Number:
  US 20070032734A1
• Time in Patent Office: 1,873 Days
• Field of Search: 607/23, 600/486, 600/488
• US Class Current: 607/23
• 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 useful in diagnosing and/or treating a cardiovascular disease within a patient, the method comprising:

providing a sensor comprising a hermetic sensor package containing at least one inductor coil and at least one sensing element operable to sense at least one physiological parameter of the patient, the sensor package having oppositely-disposed first and second portions;

assembling the sensor with an anchoring mechanism to form an implantable sensing device, the anchoring mechanism comprising oppositely-disposed first and second foldable umbrella structures located adjacent the first and second portions, respectively, of the sensor package, the first and second foldable umbrella structures having vertices that face away from each other, the sensor being assembled with the anchoring mechanism so that the sensor package thereof is between the first and second foldable umbrella structures, the second foldable umbrella structure being smaller than the first foldable umbrella structure;

implanting the sensing device by folding the first and second foldable umbrella structures of the anchoring mechanism, passing the first or second foldable umbrella structure through a septum of the heart of the patient to locate the second foldable umbrella structure within a cavity on the left side of the patient'"'"'s heart, and expanding the first and second foldable umbrella structures to engage opposite sides of the septum, wherein the entire sensing device is within the heart, the sensor package is located in the septum and the at least one sensing element senses the at least one physiological parameter in the cavity, wherein the first foldable umbrella structure and the majority of the sensing device are located in the right side of the heart to minimize the risk of thrombogenicity;

operating the sensor to produce an output based on the at least one physiological parameter within the cavity of the patient;

coupling the sensor to a non-implantable readout device that is not implanted in the patient, the readout device comprising at least one inductor coil having telemetric means that receives the output of the sensor through the at least one inductor coil of the sensing device; and

tailoring a medication treatment for treating the cardiovascular disease of the patient based on the output of the sensor.

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

3. The method according to claim 1, wherein the sensor package contains a battery, and the method comprises wirelessly recharging the battery.

4. The method according to claim 1, wherein the at least one physiological parameter is pressure sensed by the 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 physiological parameter sensed by the 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 sensing device is implanted in the atrial septum.

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

14. The method according to claim 1, wherein the method is part of 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;

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 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 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 sensing element of the sensor comprises a barometric pressure sensing element.

18. The method according to claim 17, wherein the barometric pressure sensing element 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 by folding the first and second foldable umbrella structures within a catheter, and then delivering the sensing device to the septum with the catheter.

21. The method according to claim 1, wherein the first and second foldable umbrella structures of the anchoring mechanism clamp the sensing device to the septal wall.

22. The method according to claim 1, wherein the second foldable umbrella structure of the anchoring mechanism passes through the atrial septum of the heart.

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

24. The method according to claim 23, wherein the sensing device is directly interrogated by the pacing/ICD unit.

25. The method according to claim 23, wherein the sensing device is interrogated by the pacing/ICD unit, and the method further comprises using an external unit for transmitting power to the sensing device.

26. The method according to claim 23, wherein the sensing device transmits data to the readout device, and the readout device retransmits the data to the pacing/ICD unit.

27. The method according to claim 26, wherein the readout device and the pacing/ICD unit perform at least one function of interrogation or powering of the sensing device.

28. A method of monitoring one or more physiological parameters useful in diagnosing and/or treating a cardiovascular disease within a patient, the method comprising:

providing a sensor comprising a hermetic sensor package containing at least one inductor coil and at least one sensing element operable to sense at least one physiological parameter of the patient, the sensor package having oppositely-disposed first and second portions;

assembling the sensor with an anchoring mechanism to form an implantable sensing device, the anchoring mechanism comprising oppositely-disposed first and second foldable umbrella structures located adjacent the first and second portions, respectively, of the sensor package, the first and second foldable umbrella structures having vertices that face away from each other, the sensor being assembled with the anchoring mechanism so that the sensor package thereof is between the first and second foldable umbrella structures, the second foldable umbrella structure being smaller than the first foldable umbrella structure;

implanting the sensing device by folding the first and second foldable umbrella structures of the anchoring mechanism, passing the first or second foldable umbrella structure through a septum of the heart of the patient to locate the second foldable umbrella structure within a cavity on the left side of the patient'"'"'s heart, and expanding the first and second foldable umbrella structures to engage opposite sides of the septum, wherein the entire sensing device is within the heart, the sensor package is located in the septum and the at least one sensing element senses the at least one physiological parameter in the cavity, wherein the first foldable umbrella structure and the majority of the sensing device are located in the right side of the heart to minimize the risk of thrombogenicity;

operating the sensor to produce an output based on the at least one physiological parameter within the cavity of the patient;

coupling the sensor to a non-implantable readout device that is not implanted in the patient, the readout device comprising at least one inductor coil having telemetric means that receives the output of the sensor through the at least one inductor coil of the sensing device; and

tailoring a medication treatment for treating the cardiovascular disease of the patient based on the output of the sensor.