Implantable wireless sensor for pressure measurement within the heart

• US 7,481,771 B2
• Filed: 07/07/2004
• Issued: 01/27/2009
• Est. Priority Date: 01/22/2002
• Status: Active Grant

• Current Assignee: St. Jude Medical Luxembourg Holdings Ii S.A.R.L.
• Original Assignee: CardioMEMS Incorporated
• Inventors: Allen, Mark, White, Jason, Stern, David, Kroh, Jason, Fonseca, Michael
• Primary Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US10/886,829
• Publication Number:
  US 20050015014A1
• Time in Patent Office: 1,665 Days
• Field of Search: 600/488, 600/486, 600/587, 600/407, 600/412, 600/421, 600/422, 600/431, 600/485, 600/552, 600/553, 600/561, 600/420, 607/60, 607/156, 324/652
• US Class Current: 600/486
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00

Abstract

The progress of a endovascular cardiac repair can be monitored by inserting a pressure transducer sensor using a catheter into a chamber of the heart during endovascular repair and then using a small, hand-held read out device to measure pressure easily, safely, inexpensively and accurately. In one aspect a sensor is introduced into the body by the steps of folding or rolling the sensor into a cylinder, loading it into a catheter, and deploying into the heart chamber by allowing it to unroll or unfold, either by itself or facilitated by the incorporation of a super-elastic alloy component.

Claims

1. An apparatus comprising:

an elongated catheter having proximal and distal ends and having a lumen extending therethrough, said lumen having a cross-sectional area;

a push rod slidably disposed within said lumen of said catheter;

said catheter and said push rod being arranged such that there is a recess formed at said distal end of said catheter; and

a flexible sensor for wirelessly determining a physical property in a patient'"'"'s heart chamber, which sensor comprises a self-contained resonant circuit a that is variable in response to said physical property, and said sensor being folded and received within said recess at said distal end of said catheter.

2. An apparatus comprising:

an elongated catheter having proximal and distal ends and having a lumen extending therethrough, said lumen having a cross-sectional area;

a push rod slidably disposed within said lumen of said catheter;

said catheter and said push rod being arranged such that there is a recess formed at said distal end of said catheter; and

a flexible sensor for wirelessly determining a physical property in a patient'"'"'s heart chamber, which sensor comprises a self-contained resonant circuit comprising a capacitor and an inductor, wherein the circuit is variable in response to said physical property, wherein the capacitance of the capacitor is variable in response to the physical property of the patient, wherein the inductor is adapted to allow inductance of a current in the resonant circuit when the sensor is subjected to a time-varying electromagnetic field, and said sensor being folded and received within said recess at said distal end of said catheter.

3. An apparatus comprising:

an elongated catheter having proximal and distal ends and having a lumen extending therethrough, said lumen having a cross-sectional area;

a push rod slidably disposed within said lumen of said catheter;

said catheter and said push rod being arranged such that there is a recess formed at said distal end of said catheter; and

a flexible sensor for wirelessly determining a physical property in a patient'"'"'s heart chamber, which sensor comprises a self-contained resonant circuit comprising a capacitor and an inductor, wherein the circuit is variable in response to the physical property of the patient, and wherein the sensor has an anchoring system attached to a flat surface of the sensor, and said sensor being folded and received within said recess at said distal end of said catheter.

4. The sensor of claim 3, wherein the capacitance of the capacitor is variable in response to the physical property of the patient.

5. The sensor of claim 3, wherein the inductor is adapted to allow inductance of a current in the resonant circuit when the sensor is subjected to a time-varying electromagnetic field.

6. The sensor of claim 3, wherein the physical property is pressure or temperature.

7. The sensor of claim 6, wherein the physical property is pressure.

8. The sensor of claim 3, wherein the sensor is disk- shaped.

9. The sensor of claim 8, wherein the sensor has one or more metallic members attached to a flat surface of the sensor.

10. The sensor of claim 8, wherein the sensor has one or more metallic members layered within the sensor.

11. The sensor of claim 8, wherein the sensor has a metallic ring surrounding a portion of the edge of the sensor.

12. The sensor of claim 3, wherein the sensor has a daisy or flower shape.

13. The sensor of claim 3 wherein the sensor has a shape so that portions of the sensor can be folded at an approximately 90°

angle to a substantially flat middle section.

14. The sensor of claim 3, wherein the anchoring system is a coil.

15. The sensor of claim 3, wherein the anchoring system has a projection with umbrella-like radial projections.

16. The sensor of claim 3, wherein the sensor has one or more cut-outs to facilitate folding.

17. The sensor of claim 3, which can be folded into a U-shape.

18. The sensor of claim 3, wherein the primary material of construction is flexible, biocompatible polymer or co-polymer.

19. The sensor of claim 18, wherein the polymer or co-polymer is selected from the group consisting of polyamide, polyethylene teraphthalate, polytetrafluoroethlyene, and co-polymers thereof.

20. The sensor of claim 3, which contains a non-linear element and responds in a non-linear manner to an excitation signal.

21. The sensor of claim 3, wherein the capacitance is distributed across an array of smaller capacitors.

22. The sensor of claim 3, which can be folded so that a middle section remains substantially flat, the outer edges or surfaces are at substantially a 90°

angle to said middle section, and a portion of the inductor is substantially coextensive with the outer edge.

23. The sensor of claim 22, which is substantially daisy-shaped.

24. A sensor comprising:

a first layer of material having an upper surface and a lower surface,

a first capacitor element disposed on a central portion of said lower surface of said first layer of material;

a first inductor element disposed on said lower surface of said first layer of material coplanar with said first capacitor element and electrically connected to said first capacitor element;

a second layer of material having an upper surface and a lower surface, said second layer of material being disposed in generally parallel, spaced-apart relation to said first layer of material with said lower surface of said first layer of material and said upper surface of said second layer of material being adjacent one another;

a second capacitor element disposed on a central portion of said upper surface of said second layer of material;

a second inductor element disposed on said upper surface of said second layer of material coplanar with said second capacitor element and electrically connected to said second capacitor element;

a third layer of material extending between said lower surface of said first layer of material and said upper surface of said second layer of material, said third layer of material being interposed between said first and second inductor elements, said third layer of material having an opening formed in a central portion thereof substantially in alignment with said first and second capacitor elements and maintaining said first and second capacitor elements in spaced-apart relation, said opening being dimensioned and configured such that said first and second capacitor elements are moveable toward and away from one another in response to changes in pressure against the upper surface of said first layer of material and the lower surface of said second layer of material;

said first and second capacitor elements forming a capacitor,

said first and second inductor elements forming an inductor,

said capacitor and inductor forming a self-contained resonant circuit, and

the capacitance of said resonant circuit being variable in response to changes in pressure in the surrounding environment.

25. The sensor of claim 24, wherein said first and second inductor elements comprise coils.

26. The sensor of claim 24,

wherein said first inductor element is substantially concentric with said first capacitor element, and

wherein said second inductor element is substantially concentric with said second capacitor element.

27. The sensor of claim 24, wherein said first and second capacitor elements comprise circular plates.

28. The sensor of claim 24, wherein said third layer of material comprises an adhesive that bonds said first layer of material to said second layer of material.

29. The sensor of claim 24, wherein said first and second inductor elements are embedded in said third material.

30. The sensor of claim 24, wherein the inductor is operative to allow inductance of a current in the resonant circuit when the sensor is subjected to a time-varying electromagnetic field.

31. The sensor of claim 24, wherein the material comprising said first and second layers is flexible, biocompatible polymer or co-polymer.

32. The sensor of claim 31, wherein the polymer or co-polymer is selected from the group consisting of polyamide, polyethylene teraphthalate, polytetrafluoroethlyene, and co-polymers thereof.