Wireless device and system for monitoring physiologic parameters

• US 9,498,130 B2
• Filed: 03/06/2009
• Issued: 11/22/2016
• Est. Priority Date: 10/03/2002
• Status: Active Grant

• Current Assignee: UIM Pressure Implant Incorporated
• Original Assignee: Integrated Sensing Systems Incorporated
• Inventors: Najafi, Nader, Massoud-Ansari, Sonbol, Rich, Collin Anderson
• Primary Examiner(s): WESTON, TIFFANY C
• Application Number:
  US12/399,131
• Publication Number:
  US 20090182206A1
• Time in Patent Office: 2,818 Days
• Field of Search: 600/481, 600483-489, 600/508, 600/513, 607/23
• US Class Current: 1/1
• 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, the miniature implant comprising an implantable self-contained sensor module that is sized and configured to be entirely implanted within a living body and physically coupled to a wall of an internal organ of the living body, the sensor module comprising:

a sensor adapted to sense a physiologic parameter of the living body;

an inductor coil adapted to receive operating power from a magnetic field generated outside the living body;

means for conditioning a sensor signal received from the sensor and generate therefrom a conditioned sensor signal;

means for transmitting the conditioned sensor signal to a location outside the living body via magnetic telemetry;

an outer shell that houses the inductor coil, the conditioning means and the transmitting means; and

an anchoring mechanism exterior to the outer shell and adapted to physically couple the outer shell to the wall of the internal organ;

wherein the miniature implant is adapted to be entirely implanted within the living body and solely positioned and anchored within the living body by the anchoring mechanism, and wherein the sensor module is sized and configured to be delivered and implanted with a catheter.

2. The miniature implant of claim 1 wherein the sensor module is sized and configured to be implanted using a minimally invasive outpatient technique.

3. The miniature implant of claim 1 wherein the anchoring mechanism is sized and configured to pass entirely through a septal wall of a heart, engage opposite surfaces of the septal wall, and clamp the sensor module to the septal wall.

4. The miniature implant of claim 3 wherein the septal wall is an atrial septum and the sensor module and the anchoring mechanism are sized and configured to pass entirely through the atrial septum.

5. The miniature implant claim 3 wherein the anchoring mechanism comprises two umbrella-shaped anchors that are sized and configured to engage opposite surfaces of the septal wall and clamp the septal wall therebetween.

6. The miniature implant claim 5 wherein the outer shell and the anchoring mechanism are coupled to each other and sized and configured so that a larger portion of the sensor module can be located in the right side of the heart and a relatively smaller portion of the sensor module can be located in the left side of the heart.

7. The miniature implant of claim 1 wherein the anchoring mechanism comprises a helical screw.

8. The miniature implant of claim 1 wherein the anchoring mechanism comprises an expandable tine that is sized and configured to implant the sensor module on a trabeculated area of the heart.

9. The miniature implant of claim 1 wherein the anchoring mechanism is made from one or more of nitinol, teflon, stainless steel, polymer, titanium, and biocompatible metals.

10. The miniature implant of claim 1 wherein at least a portion of the sensor module is coated with one or more layers of at least one coating material.

11. The miniature implant of claim 10 wherein the at least one coating material is at least one of silicone, hydrogels, parylene, polymer, nitrides, oxides, nitric-oxide generating materials, carbides, silicides, and titanium.

12. The miniature implant of claim 1, wherein the outer shell defines a cylindrical-shaped package.

13. A method of using the miniature implant of claim 1 in a medical application chosen from the group consisting of cardiovascular diseases, congestive heart failure, congenital heart diseases, diseases related to intracranial pressure, abdominal aortic aneurysm, intraocular pressure for eye related diseases urinary diseases, and gastrointestinal diseases.

14. The miniature implant of claim 1 wherein the sensor is adapted to sense pressure, temperature, flow, blood composition, blood gas content, chemical composition, acceleration, or vibration.

15. A method of using the miniature implant of claim 1 to monitor the physiologic parameter of the internal organ.

16. The method of claim 15 wherein the physiologic parameter is pressure.

17. The method of claim 15 wherein the internal organ is a heart, brain, kidney, lung, or abdomen.

18. The method of claim 15 wherein the pressure is left ventricular end diastolic pressure, left atrium pressure, left atrium appendage pressure, mean left atrium pressure, in the left side of the heart, in the right side of the heart, right atrium pressure, mean right atrium pressure, right ventricular end diastolic pressure, differential pressure between left and right atrium, intracranial pressure, or intraocular pressure.