Method and apparatus for analyte detection using intradermally implanted skin port

• US 6,438,397 B1
• Filed: 10/28/1999
• Issued: 08/20/2002
• Est. Priority Date: 10/28/1999
• Status: Expired due to Fees

• Current Assignee: Ashok Gowda, Gerald G. Bosquet, Gerald L. Cote, Roger Mcnichols, Sohi Rastegar
• Original Assignee: Ashok Gowda, Gerald G. Bosquet, Gerald L. Cote, Roger Mcnichols, Sohi Rastegar
• Inventors: Gowda, Ashok, McNichols, Roger, Rastegar, Sohi, Cote, Gerald L., Bosquet, Gerald G.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): KREMER, MATTHEW J
• Application Number:
  US09/429,191
• Publication Number:
  US 20020072657A1
• Time in Patent Office: 1,027 Days
• Field of Search: 600/309-311, 600/322-328, 600/339-344, 600/473, 600/476, 600/316, 356/39-42
• US Class Current: 600/310
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/6865 Access ports

Abstract

A transcutaneous, implantable skin port sensor includes an access component and a sensor component, both of which can be made from inexpensive biocompatible materials. The access component provides a biological seal that forms around the skin port sensor. The sensor component facilitates non-invasive optically based measurement of analytes by providing a window to the body which avoids changes in the optical signal due to variations in skin optics, optical pathlength, ambient temperature and probe pressure. Tissue ingrowth or interstitial fluid in a through portion downstream of the optical window serves as the sample for the non-invasive, optically based measurement.

Claims

1. An apparatus for facilitating measurement of analyte concentration comprising:

a housing;

an optical window in the housing, the housing having a through portion downstream of the optical window in a path of optical radiation supplied to the window;

an optical output portion, downstream of the through portion in the path of optical radiation, which outputs optical radiation transmitted by a sample in the through portion to an analysis unit; and

a transcutaneous access device adapted for securing the housing to a subject, wherein the housing is at a predetermined location relative to the transcutaneous access device.

2. The apparatus of claim 1, wherein the optical output portion comprises a reflective surface directing the optical radiation back through the through portion and the optical window.

3. The apparatus of claim 2, wherein the reflective surface is shaped to focus the optical radiation back through the through portion and the optical window.

4. The apparatus of claim 2, wherein the reflective surface includes an active optical coating.

5. The apparatus of claim 2, wherein the reflective surface comprises a biologically active mirror coating which promotes vascular ingrowth.

6. The apparatus of claim 1, wherein the optical window focuses the optical radiation onto the through portion.

7. The apparatus of claim 1, wherein the through portion comprises a porous wall structure which promotes vascular ingrowth.

8. The apparatus of claim 1, wherein the through portion comprises a porous wall structure which prevents vascular ingrowth, while allowing interstitial fluid to pass therethrough.

9. The apparatus of claim 1, wherein a size of the through portion is fixed.

10. The apparatus of claim 1, wherein the housing is recessed within the transcutaneous access device.

11. The apparatus of claim 1, wherein the output optical portion comprises another housing, another optical window in the another housing, the another optical window transmitting optical radiation transmitted by the sample in the through portion and another transcutaneous access portion in which the another housing is secured to the subject.

12. The apparatus of claim 11, wherein the another optical window is shaped to focus light passing therethrough.

13. A system for measuring analyte concentration comprising:

a housing;

an optical window in the housing, the housing having a through portion downstream of the optical window in the path of optical radiation supplied to the window

an optical output portion, downstream of the through portion in the path of optical radiation, which outputs optical radiation transmitted by a sample in the through portion;

a transcutaneous access device, adapted to be anchored to subcutaneous tissue of a patient, holding the housing at a predetermined location relative to the transcutaneous access device;

an optical source for supplying optical radiation to the optical window; and

a delivery system for supplying the optical radiation output by the optical output portion to instrumentation for analysis of analyte concentration.

14. The system of claim 13, wherein the optical source is one of an NIR source and a MIR source.

15. The system of claim 13, wherein said optical source is fluorescence excitation within the housing.

16. The system of claim 13, wherein said optical source is a body in which housing has been implanted.

17. The apparatus of claim 13, wherein the housing is recessed within the transcutaneous access device.

18. A method of obtaining optical data for use in determining analyte concentration comprising:

implanting a transcutaneous access device in a subject;

securing a sensor portion in the transcutaneous access device, the sensor portion including an optical window and a through portion downstream of the optical window in a path of optical radiation supplied to the optical window, wherein the through portion has a fixed distance relative to the transcutaneous access device;

providing optical radiation through the optical window to the through portion; and

supplying optical radiation transmitted by a sample in the through portion in response to said providing to instrumentation for determining a corresponding analyte concentration.

19. The method of claim 18, wherein said supplying comprises reflecting optical radiation transmitted by the sample in the through portion back through the through portion and the optical window.

20. The method of claim 18, wherein said supplying comprises transmitting optical radiation transmitted by the sample in the through portion.

21. A method of obtaining optical data for use in determining analyte concentration comprising:

providing optical radiation from a source to a sensor portion of a device, wherein the sensor portion is affixed to a transcutaneous access portion of the device which is secured to a patient;

transmitting said optical radiation through the sensor portion, the sensor portion including an optical window and a through portion downstream of the optical window in a path of the optical radiation, wherein the optical window is at a fixed location with respect to the transcutaneous access portion; and

supplying optical radiation that has been at least one of transmitted and reflected by a sample in the through portion to instrumentation for determining a corresponding analyte concentration.

22. The method of claim 21, wherein the step of supplying includes reflecting at least a portion of the optical radiation that has been transmitted by the sample toward the optical window.

23. The method of claim 21, wherein the step of supplying includes determining a corresponding analyte concentration based on optical radiation that has been transmitted by the sample.

24. An apparatus comprising:

a first portion adapted to be anchored in subcutaneous tissue of a patient;

a neck portion having a distal end, and a proximal end having an inside lumen, the neck portion extending from one side of the first portion, the proximal end adapted to be external the patient; and

a sensor portion coupled to the neck portion to prevent subcutaneous access from the inside lumen of the proximal end.

25. The apparatus of claim 24, wherein the sensor portion further comprises an optical window.

26. The apparatus of claim 25, wherein the optical window is a fixed distance from the first portion.