WIRELESS DEVICE AND SYSTEM FOR MONITORING PHYSIOLOGIC PARAMETERS

• US 20090182206A1
• Filed: 03/06/2009
• Published: 07/16/2009
• 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, Massoud-Ansari, Sonbol
• Granted Patent: US 9,498,130 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling

Abstract

A system for monitoring blood pressure and other physiologic parameters is provided. The system is designed such that it can be delivered to the patient with ease and minimal invasion. The system contains at least one self contained implantable sensing device consisting of a sensor, an electrical circuit for signal conditioning and magnetic telemetry, a biocompatible outer surface and seal, an anchoring method, and an external readout device. The implant is small in size so that it may be delivered to the desired location and implanted using a catheter, although direct surgical implantation is also possible. The circuit, sensor, and antenna for telemetry are packaged together and sealed hermetically to the biologic environment. The larger readout unit remains outside the body but proximal to the implant for minimizing communication distance.

Claims

1. A miniature implant for measuring physiologic parameters for medical applications, comprising:

Implantable self-contained sensor module for measuring physiologic parameters wherein the module;

senses physiologic parameters with a sensor;

receives operating power from a magnetic field with an inductor coil;

conditions a sensor signal;

transmits a conditioned sensor signal to an external signal detection system via magnetic telemetry;

outer shell to house sensor module fit with anchoring mechanism for implantation.

2. The system of claim 1 wherein said implantable sensing device is implanted using a minimally invasive outpatient technique

3. The miniature implant of claim 1 wherein the implant is delivered and implanted with a catheter.

4. The miniature implant of claim 1 wherein said anchoring mechanism passes through a septum wall and opens on either side of a septal wall, clamping the implant to the wall.

5. The system of claim 4 wherein said anchoring mechanism utilizes an anchor that passes through the atrial septum.

6. The system of claim 5 wherein said anchoring method is similar to anchoring of septum occluder devices, wherein two umbrella-shaped anchors one on each side which anchor the sensing device.

7. The system of claim 5 wherein the larger portion of said implantable sensing device is located in the right side of the heart and the smaller portion of said implantable sensing device is located in the left side.

8. The miniature implant of claim 1 wherein said anchoring mechanism is a helical screw.

9. The miniature implant of claim 1 wherein said anchoring mechanism is a tine that expands and catches on a tribeculated area of the heart.

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

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

11. The system of claim 1 wherein at least a portion of said sensor module is coated with one or more layers of thin coatings.

12. The system of claim 11 wherein said coating materials include but are not limited to one or more or any combination thereof:

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

33. The implant of claim 1 wherein said module is used for applications including but not limited to one or more of the following:

cardiovascular diseases, congestive heart failure, congenital heart diseases, diseases related to intracranial pressure, abdominal aortic aneurysm, intraocular pressure for eye related diseases including but not limited to glaucoma, urinary diseases, gastrointestinal diseases.

35. The sensor module of claim 1 wherein said sensor measures one or more of the following parameters pressure, temperature, flow , blood composition, blood gas content, chemical composition, acceleration, vibration.

37. The sensor module of claim 1 wherein one or more sensing devices are measuring one or more physiological parameters relating to one or more internal organs

38. The sensor module of claim 37 wherein said physiological parameters include pressure.

39. The sensor module of claim 37 wherein said internal organs include but are not limited to one or more of the following organs:

heart, brain, kidney, lung, abdomen.

40. The sensor module of claim 38 wherein one or more sensing devices are measuring one or more 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, intracranial pressure, intraocular pressure.

13. A wireless sensing system for medical applications, comprising:

Implantable self-contained sensor module for measuring physiologic parameters wherein the module;

senses physiologic parameters with a sensor;

receives operating power from a magnetic field with an inductor coil;

conditions a sensor signal;

transmits a conditioned sensor signal to an external signal detection system via magnetic telemetry;

External readout unit wherein the unit;

transmits magnetic field to power the sensor module;

receives a signal from the implant module.

14. The wireless sensing system of claim 13 wherein said external readout unit communicates information to the implant.

15. The wireless sensing system of claim 13 wherein said external readout unit interfaces to a display for the user.

16. The wireless sensing system of claim 13 wherein said external readout unit interfaces to a computer for data storage.

17. The wireless sensing system of claim 13 wherein said computer interfaces with a computer network.

18. The wireless sensing system of claim 13 wherein said external readout unit processes the data for indicating urgency of medical attention.

19. The wireless sensing system of claim 13 wherein said external readout unit is capable of performing one or more of the following:

remote monitoring of patients, including but not limited to home monitoring;

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

monitoring of 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 diseases;

closed-loop pacemaker parameter tuning to treat related diseases;

warning systems for critical worsening of diseases and related conditions;

portable or ambulatory monitoring or diagnostic systems;

battery-operation capability;

data storage;

reporting global positioning coordinates for emergency applications;

communication with other medical devices including but not limited to pacemakers, defibrillator, implantable cardioverter defibrillator, implantable drug delivery systems, non-implantable drug delivery systems, and wireless medical management systems.

20. The system of claim 13 wherein said readout unit includes a barometric pressure sensor.

21. The system of claim 20 wherein said barometric pressure sensor is used to compensate for variations in atmospheric pressure.

22. The system of claim 13 wherein said implantable sensing system is implanted using a minimally invasive outpatient technique.

23. The miniature implant of claim 13 wherein said implant is delivered and implanted with a catheter.

24. The miniature implant of claim 13 wherein said anchoring mechanism passes through a septum wall and opens on either side of a septal wall, clamping the implant to the wall.

25. The system of claim 13 wherein said anchoring mechanism utilizes an anchor that passes through the atrial septum.

26. The system of claim 25 wherein said anchoring method is similar to anchoring of septum occluder devices, wherein two umbrella-shaped anchors one on each side which anchor the sensing device.

27. The system of claim 25 wherein the larger portion of said implantable sensing device is located in the right side of the heart and the smaller portion of said implantable sensing device is located in the left side.

28. The miniature implant of claim 13 wherein said anchoring mechanism is a helical screw.

29. The miniature implant of claim 13 wherein said anchoring mechanism is a tine that expands and catches on a tribeculated area of the heart.

30. The system of claim 13 wherein said anchoring mechanism is made from one or more or any combination thereof the following materials:

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

31. The system of claim 13 wherein at least a portion of said sensor module is coated with one or more layers of thin coatings.

32. The system of claim 31 wherein said coating materials include but are not limited to one or more or any combination thereof:

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

34. The wireless sensing system of claim 13 wherein said module is used for applications including but not limited to one or more of the following:

cardiovascular diseases, congestive heart failure, congenital heart diseases, diseases related to intracranial pressure, abdominal aortic aneurysm, intraocular pressure for eye related diseases including but not limited to glaucoma, urinary diseases, gastrointestinal diseases.

36. The sensor module of claim 13 wherein said sensor measures one or more of the following parameters:

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

41. The sensor module of claim 13 wherein one or more sensing devices are measuring one or more physiological parameters relating to one or more internal organs

42. The sensor module of claim 41 wherein said physiological parameters include pressure.

43. The sensor module of claim 41 wherein said internal organs include but are not limited to one or more of the following organs:

heart, brain, kidney, lung, abdomen.

44. The sensor module of claim 42 wherein one or more sensing devices are measuring one or more 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, intracranial pressure, intraocular pressure.