Methods for using an implantable sensor unit

• US 7,479,108 B2
• Filed: 04/13/2006
• Issued: 01/20/2009
• Est. Priority Date: 01/29/2002
• Status: Active Grant

• Current Assignee: SNC Holdings Corp.
• Original Assignee: Sicel Technologies, Inc.
• Inventors: Rini, Christopher J., Black, Robert D.
• Primary Examiner(s): Astorino; Michael C
• Assistant Examiner(s): Rajan; Kai
• Application Number:
  US11/403,522
• Publication Number:
  US 20060183979A1
• Time in Patent Office: 1,013 Days
• Field of Search: 600/300, 600/301, 600/426, 128903-905, 128/920
• US Class Current: 600/300
• CPC Class Codes: A61B 2503/40 Animals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A method for obtaining data using an implantable sensor unit in a body of a patient includes: implanting the sensor unit in the body; conducting an imaging procedure on the body such that the sensor unit in the body serves as a fiducial marker; detecting a parameter using the sensor unit in the body; and transmitting data associated with the detected parameter from the sensor unit to a remote receiver unit.

Claims

1. A method for obtaining data using an implantable sensor unit in a body of a patient, the method comprising:

a) implanting the sensor unit in the body at a position adjacent or in a cancerous tumor;

b) conducting an imaging procedure on the body, including using the sensor unit in the body as a fiducial marker;

c) detecting externally generated radiation using the sensor unit in the body; and

d) transmitting data used to measure the detected externally generated radiation from the sensor unit to a remote receiver unit.

2. The method of claim 1 wherein the imaging procedure includes a radiographic imaging procedure and wherein at least a portion of the sensor unit is radiopaque.

3. The method of claim 1 further including:

implanting at least one additional sensor unit in the body; and

using the at least one additional sensor unit as a fiducial marker or fiducial markers for the imaging procedure.

4. The method of claim 3 further including:

implanting a plurality of additional sensor units in the body; and

using each of the plurality of additional sensor units as fiducial markers for the imaging procedure.

5. The method of claim 1 further including:

implanting at least one additional sensor unit in the body;

detecting an additional parameter using the at least one additional sensor unit in the body; and

transmitting data associated with the detected additional parameter from the at least one additional sensor unit to the remote receiver unit.

6. The method of claim 1 wherein the sensor unit includes a sensor housing comprising glass.

7. The method of claim 1 wherein the sensor unit includes a sensor housing defining a chamber and includes sensor electronics disposed in the chamber, wherein the sensor electronics are adapted to wirelessly transmit data.

8. The method of claim 7 wherein the sensor unit further includes:

an epoxy disposed in a first portion of the chamber and encapsulating at least a portion of the sensor electronics; and

a gas disposed in a second portion of the chamber between the epoxy and an end portion of the sensor housing.

9. The method of claim 7 wherein the sensor unit is configured to wirelessly transmit data from an in vivo position to the remote receiver over a period of at least about four weeks and wherein the sensor housing is adapted to provide a hermetic seal about the sensor electronics for a period of at least about four weeks, wherein the hermetic seal is such that under a helium mass spectrometer leak detection test, the sensor housing has a leak rate that is less than about 10⁻

8 atm-cc/s.

10. The method of claim 7 wherein the sensor electronics include a first portion and a second portion joined to the first portion at a junction, the sensor unit further includes an epoxy disposed in the chamber and surrounding the junction, and the epoxy mechanically stabilizes the first and second portions.

11. The method of claim 1 wherein the sensor unit includes a sensor housing having a length of no more than about 27 mm and an outer diameter of no more than about 3.5 mm.

12. The method of claim 1 wherein the sensor unit includes a sensor housing that is hermetically sealed.

13. The method of claim 1 wherein the sensor unit includes a sensor housing that is laser welded.

14. The method of claim 1 wherein the sensor unit includes a sensor housing that is flame sealed.

15. The method of claim 1 wherein the sensor unit includes a sensor housing having an outer surface, the sensor unit further includes a bio-compatible anti-migration layer encasing at least a portion of the outer surface of the sensor housing, and the anti-migration layer is formed of a textile material.

16. The method of claim 15 wherein the anti-migration layer is a flexible sleeve.

17. The method of claim 16 wherein the sleeve fully envelops the sensor housing.

18. The method of claim 15 wherein the anti-migration layer comprises a multi-filament textile material.

19. The method of claim 18 wherein the anti-migration layer comprises a multi-filament suture material.

20. The method of claim 18 wherein the anti-migration layer comprises a braided material in which one or more strands half twist alternately about two or more adjacent strands.

21. The method of claim 18 wherein the anti-migration layer comprises polyester filaments.

22. The method of claim 15 wherein the textile material includes a polyester mesh.

23. The method of claim 15 wherein the textile material is substantially non-absorbable and non-degradable in a human body.

24. The method of claim 15 wherein the anti-migration layer includes a sleeve of the textile material, wherein an end of the sleeve is closed to form a holding tab, the holding tab being adapted to facilitate handling of the sensor housing.

25. The method of claim 1 wherein the sensor unit includes a sensor housing and a holding tab extending beyond an end of the sensor housing, the holding tab being adapted to facilitate handling of the sensor housing.

26. The method of claim 25 wherein the holding tab is flexible.

27. The method of claim 25 including affixing the sensor unit to local tissue of the body using the holding tab.

28. The method of claim 27 including affixing the sensor unit to local tissue of the body using at least one suture or staple extending through the holding tab and the tissue.

29. The method of claim 1 wherein the sensor unit further includes a sensor housing and a retention device mounted on the sensor housing, the retention device including at least one projection extending away from the sensor housing.

30. The method of claim 29 wherein the retention device includes a band surrounding a portion of the sensor housing.

31. The method of claim 1 wherein the sensor unit includes means to retain the sensor unit in an implanted position in the body during at least the steps of conducting the imaging procedure and detecting the parameter.

32. The method of claim 1 wherein each of the sensor units includes a respective sensor housing and the sensor units are spaced apart from one another in the body.

33. The method of claim 32 further including:

detecting an additional parameter using the at least one additional sensor unit in the body; and

transmitting data associated with the detected additional parameter from the at least one additional sensor unit to the remote receiver unit.

34. A method for obtaining data using a plurality of implantable sensor units in a body of a patient, the method comprising:

implanting a first sensor unit in the body at a first position adjacent or in a cancerous tumor, the first sensor unit having a first sensor housing;

implanting a second sensor unit in the body at a second position spaced apart from the first sensor unit, the second sensor unit having a second sensor housing;

conducting an imaging procedure on the body, including using the first and second sensor units in the body as fiducial markers;

detecting a parameter using at least one of the first and second sensor units in the body; and

transmitting data associated with the parameter from the at least one of the first and second sensor units to a remote receiver unit.

35. The method of claim 34 including:

detecting a first parameter using the first sensor unit in the body; and

transmitting data associated with the first parameter from the first sensor unit to the remote receiver unit;

detecting a second parameter using the second sensor unit in the body; and

transmitting data associated with the second parameter from the second sensor unit to the remote receiver unit.