System for monitoring the physiologic parameters of patients with congestive heart failure

• US 7,615,010 B1
• Filed: 10/02/2003
• Issued: 11/10/2009
• 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 Anderson
• Primary Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US10/677,694
• Time in Patent Office: 2,231 Days
• Field of Search: 607/6, 600/300, 600/339, 600/481, 600/485, 600/504, 600/549
• US Class Current: 600/481
• 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 telemetric sensing system for monitoring physiological parameters for diagnosis and treatment of congestive heart failure in a patient. This system includes one or more implantable sensing devices implanted in a cavity of the patient'"'"'s cardiovascular system, and a non-implantable reader unit. The implantable sensing device has an inductor and at least one sensor with an option of having electronic components, as well as a mechanism for anchoring the device inside the patient'"'"'s body. The external readout device has at least one inductor coil with a telemetric device that provides for at least one of electromagnetic telecommunication and wireless powering of the sensing device. This wireless system provides a means for effective monitoring, management and tailoring of treatments for patients suffering from congestive heart failure as well as many other diseases.

Claims

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

at least one sensing device adapted to be implanted in a septum of the patient'"'"'s heart and monitor said one or more physiological parameters within a heart cavity, said sensing device comprising an anchoring mechanism, at least one inductor coil and at least one sensor, with optional electronic components, said anchoring mechanism comprising first and second portions that are separated by the sensor and are both foldable and expandable, the first portion being adapted to pass through an opening of the septum and expand on a distal side thereof within the heart cavity, the second portion being adapted to expand on an oppositely-disposed proximal side of the septum, the first and second portions being configured to clamp the septum therebetween, said sensor being disposed relative to the anchoring mechanism so that when said sensing device is implanted in the septum from the proximal side thereof and said sensor is within the opening in the septum, the first portion of the anchoring mechanism and a majority of said sensing device are located on the proximal side of the septum, said sensing device has minimum protrusion in the heart cavity on the distal side of the septum to minimize the risk of thrombogenicity, and said sensor is configured to monitor the one or more physiological parameters within the heart cavity;

a pacing/ICD unit for interrogating said at least one sensing device;

an external unit for powering said at least one sensing device; and

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

2. The system of claim 1 wherein said system is adapted for use in at least one of the following applications:

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, treatment of mitral valve stenosis.

3. The system of claim 1 wherein said at least one sensor of the implantable sensing device comprises at least one capacitive sensor.

4. The system of claim 1 wherein said readout device is adapted for use in 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 (or similar method) data and information delivery, monitoring of congestive heart failure patients with web-based (or similar method) 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, defibrillator, implantable cardioverter defibrillator, implantable drug delivery systems, non-implantable drug delivery systems, and wireless medical management systems.

5. The system of claim 1 wherein the implantable sensing device includes a battery.

6. The system of claim 5 wherein the battery is rechargeable using wireless means.

7. The system of claim 1 wherein said non-implantable readout device includes a barometric pressure sensor.

8. The system of claim 7 wherein said barometric pressure sensor is adapted to compensate for variations in atmospheric pressure.

9. The system of claim 1 wherein the one or more physiological parameters include pressure.

10. The system of claim 1 wherein said implantable sensing device is configured for implantation using a minimally invasive outpatient technique.

11. The system of claim 9 wherein the at least one sensing device is adapted to be implanted so as to measure at least one of the following pressures:

left ventricular end diastolic pressure, left atrium, left atrium appendage, mean left atrium pressure, left side of the heart, right side of the heart, right atrium, mean right atrium pressure, right ventricular end diastolic pressure, differential pressure between left and right atrium.

12. The system of claim 11 wherein said system calculates the change of pressure over time (dp/dt).

13. The system of claim 1 wherein said implantable sensing device is augmented with at least one actuator chosen from the group consisting of:

thermal generators, voltage sources, current sources, probes, electrodes, drug delivery pumps, valves, meters, microtools for localized surgical procedures, radiation emitting sources, defibrillators, muscle stimulators, pacing stimulators.

15. The system of claim 1 wherein at least a portion of said implantable sensing device is coated with one or more layers of at least one coating material.

16. The system of claim 15 wherein the at least one coating material is chosen from the group consisting of:

silicone, hydrogels, parylene, polymer, nitrides, oxides, nitric-oxide generating materials, carbides, suicides, titanium.

17. The system of claim 1 wherein a resonant scheme is used to couple the sensing device to the readout device.

18. The system of claim 1 wherein said implantable sensing device is configured for implantation using a catheter delivery method.

19. The system of claim 1 wherein a passive scheme is used to couple the sensing device to the readout device.

20. The system of claim 1 wherein said first and second portions of said anchoring mechanism comprise two opposing umbrella-shaped structures.

21. The system of claim 1 wherein an active scheme is used to couple the sensing device to the readout device.

22. The system of claim 1 wherein said anchoring mechanism is made from one or more or any combination thereof of the following materials:

nitinol, teflon, stainless steel, polymer, titanium, biocompatible metals.

23. The system of claim 1 wherein the one or more physiologic parameters monitored by the system includes one or more of the following parameters:

pressure, temperature, flow, blood composition, blood gas content, chemical composition, acceleration, vibration.

24. The system of claim 1, wherein said at least one sensing device transmits data to said readout device, and said readout device retransmits said data to said pacing/ICD unit.

25. The system of claim 1 wherein the at least one sensing device is adapted to be implanted at a location chosen from the group consisting of:

atrial septum, ventricular septum, aorta, left ventricle, left atrium, left atrium appendage, right ventricle, right atrium, pulmonary artery, wedge position in pulmonary artery.

14. A system for monitoring one or more physiological parameters for treatment of congestive heart failure within a patient, said system comprising:

at least one sensing device adapted to be implanted in a cavity of the patient'"'"'s cardiovascular system, said sensing device comprising at least one inductor coil and at least one sensor, with optional electronic components;

a non-implantable reader adapted to present data useful for diagnosing congestive heart failure, said reader comprising at least one inductor coil allowing electromagnetic telecommunication and electromagnetic wireless powering of said sensor through said at least one inductor coil of said sensing device;

an external unit operable to transmit power to said at least one sensing device; and

wherein said system is part of a closed-loop pacing/ICD (implantable cardioverter defibrillator) tuning mechanism comprising a pacing/ICD unit, said at least one sensing device is interrogated by the pacing/ICD unit, data from said at least one sensing device is sent to the pacing/ICD unit for tailoring of pacing/ICD function, and optionally said at least one sensing device transmits data to said reader, after which said reader retransmits data to the pacing/ICD unit.

26. The system of claim 14 wherein said implantable sensing device is augmented with at least one actuator chosen from the group consisting of:

thermal generators, voltage sources, current sources, probes, electrodes, drug delivery pumps, valves, meters, microtools for localized surgical procedures, radiation emitting sources, defibrillators, muscle stimulators, pacing stimulators.

27. The system of claim 14 wherein said at least one sensor of the implantable sensing device comprises at least one capacitive sensor.

28. The system of claim 14 wherein said system is adapted for use in at least one of the following applications:

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, treatment of mitral valve stenosis.

29. The system of claim 14 wherein a resonant scheme is used to couple the sensing device to the reader.

30. The system of claim 14 wherein said reader is adapted for use in 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 (or similar method) data and information delivery, monitoring of congestive heart failure patients with web-based (or similar method) 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, defibrillator, implantable cardioverter defibrillator, implantable drug delivery systems, non-implantable drug delivery systems, and wireless medical management systems.

31. The system of claim 14 wherein the one or more physiological parameters include pressure.

32. The system of claim 31 wherein the at least one sensing device is adapted to be implanted so as to measure at least one of the following pressures:

left ventricular end diastolic pressure, left atrium, left atrium appendage, mean left atrium pressure, left side of the heart, right side of the heart, right atrium, mean right atrium pressure, right ventricular end diastolic pressure, differential pressure between left and right atrium.

33. The system of claim 32 wherein said system calculates the change of pressure over time (dp/dt).

34. The system of claim 14 wherein a passive scheme is used to couple the sensing device to the reader.

35. The system of claim 14 wherein said non-implantable reader includes a barometric pressure sensor.

36. The system of claim 35 wherein said barometric pressure sensor is adapted to compensate for variations in atmospheric pressure.

37. The system of claim 14 wherein the implantable sensing device includes a battery.

38. The system of claim 37 wherein the battery is rechargeable using wireless means.

39. The system of claim 14 wherein said implantable sensing device is configured for implantation using a minimally invasive outpatient technique.

40. The system of claim 14 wherein said implantable sensing device is configured for implantation using a catheter delivery method.

41. The system of claim 14 wherein an active scheme is used to couple the sensing device to the reader.

42. The system of claim 14 wherein the one or more physiologic parameters monitored by the system includes one or more of the following parameters:

pressure, temperature, flow, blood composition, blood gas content, chemical composition, acceleration, vibration.

43. The system of claim 14 wherein the at least one sensing device is adapted to be implanted at a location chosen from the group consisting of:

atrial septum, ventricular septum, aorta, left ventricle, left atrium, left atrium appendage, right ventricle, right atrium, pulmonary artery, wedge position in pulmonary artery.

44. The system of claim 14 wherein said at least one sensing device is directly interrogated by the pacing/ICD unit.

45. The system of claim 14 wherein said at least one sensing device transmits data to said reader, after which said reader retransmits data to the pacing/ICD unit.

46. The system of claim 45 wherein said reader and said pacing/ICD unit perform at least one function of interrogation or powering of said at least one sensing device.

47. The system of claim 14 wherein at least a portion of said implantable sensing device is coated with one or more layers of at least one coating material.

48. The system of claim 47 wherein the at least one coating material is chosen from the group consisting of:

silicone, parylene, hydrogels, polymer, nitrides, oxides, nitric-oxide generating materials, carbides, silicides, titanium.

49. The system of claim 14, wherein said implantable sensing device comprises an anchoring mechanism 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, stents.

50. The system of claim 49 wherein said anchoring mechanism comprises a portion adapted for passing through a septum wall of the heart and means adapted for opening on at least one side of the septal wall and clamping said implantable device to the septal wall.

51. The system of claim 49 wherein said anchoring mechanism comprises a portion adapted for passing through the atrial septum of the heart.

52. The system of claim 51 wherein the anchoring mechanism comprises two umbrella-shaped anchors adapted to be disposed on opposite sides of the atrial septum.

53. The system of claim 51 wherein said implantable sensing device comprises a larger portion adapted to be located in the right side of the heart and a smaller portion adapted to be located in the left side of the heart and includes at minimum said at least one sensor in order to minimize the risk of thrombogenicity.

54. The system of claim 49 wherein said anchoring mechanism is a helical screw.

55. The system of claim 49 wherein said anchoring mechanism is a tine adapted to catch on a trabeculated area of the heart.

56. The system of claim 49 wherein said anchoring mechanism is made from one or more or any combination thereof of the following materials:

nitinol, teflon, stainless steel, polymer, titanium, biocompatible metals.

57. A system for monitoring one or more physiological parameters for at least one of diagnosis and treatment of congestive heart failure within a patient, said system comprising:

at least one sensing device adapted to be implanted in a cavity of the patient'"'"'s cardiovascular system, said sensing device comprising at least one inductor coil and at least one sensor, with optional electronic components;

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

wherein the system is incorporated into a closed-loop system with a left atrium to right atrium unidirectional valve for preventing the development of pulmonary edema.