Near infrared risk assessment of diseases

• US 7,328,052 B2
• Filed: 09/17/2004
• Issued: 02/05/2008
• Est. Priority Date: 09/19/2003
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: NIR Diagnostics Incorporated
• Inventors: Samsoondar, James, MacIntyre, Duncan, Kaushal, Ashwani
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/943,737
• Publication Number:
  US 20050075546A1
• Time in Patent Office: 1,236 Days
• Field of Search: 600/306, 600/309, 600/310, 600/322, 600/323, 600/344
• US Class Current: 600/310
• CPC Class Codes: A61B 2562/0238 Optical sensor arrangements for performing transmission measurements on body tissue
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence

Abstract

The present invention provides an apparatus and a method for identifying the risk of a clinical condition in a human or animal by correlating Near Infrared (NIR) absorbance spectral data with one or several parameters including a concentration of one or more substances in the skin, a concentration of one or more substances in skin plus subdermal tissue, a score derived from one or more clinical tests like a stress test on a treadmill, coronary angiography, or intravascular coronary ultrasound. The method determines the concentration of a compound in the skin of a human or animal and comprises the steps of placing a part of the skin against a receptor, directing electromagnetic radiation (EMR) from the near-infrared spectrum onto the skin, measuring a quantity of EMR reflected by, or transmitted through, the skin with a detector; and performing a quantitative mathematical analysis of the quantity of EMR to determine the concentration of the compound, for example free and esterfied cholesterol. An example of a clinical condition is cardiovascular disease.

Claims

1. A method of identifying a clinical condition in need of treatment in a human or animal, the method comprising the steps of:

(i) determining the concentration of an analyte selected from the group consisting of a fat, a lipoprotein, and a steroid in the skin of the human or animal by a method comprising;

(a) placing a part of the skin against a receptor in a manner that removes a portion of the blood within the skin;

(b) directing electromagnetic radiation (EMR) from the near-infrared spectrum onto the skin;

(c) measuring a quantity of EMR reflected by, or transmitted through, the skin with a detector; and

(d) performing a quantitative mathematical analysis of the quantity of EMR to determine the concentration of the analyte; and

(ii) correlating the concentration of the analyte to the clinical condition in need of treatment, using a correlation algorithm.

2. The method of claim 1, wherein the analyte is free cholesterol.

3. The method of claim 1, wherein the analyte is esterfied cholesterol.

4. The method of claim 1, wherein the analyte is total cholesterol.

5. The method of claim 1, wherein in the step of placing (step (a)), the receptor presses against the skin thereby removing a portion of the blood within the skin.

6. The method of claim 1, wherein in the step of placing (step (a)), the receptor is clamped against the skin thereby removing a portion of the blood within the skin.

7. A method for assessing the risk of a clinical condition in a human or animal, the method comprising the steps of:

(i) determining the concentration of an analyte selected from the group consisting of a fat, a lipoprotein, and a steroid in the skin of the human or animal by a method comprising;

(a) placing a part of the skin against a receptor in a manner that removes a portion of the blood within the skin;

(b) directing electromagnetic radiation (EMR) from the near-infrared spectrum onto the skin;

(c) measuring a quantity of EMR reflected by, or transmitted through, the skin with a detector; and

(d) performing a quantitative mathematical analysis of the quantity of EMR to determine the concentration of the analyte; and

(ii) correlating the concentration of the analyte to the risk of a clinical condition in need of treatment by using a correlation algorithm.

8. The method of claim 7, wherein the analyte is free cholesterol.

9. The method of claim 7, wherein the analyte is esterfied cholesterol.

10. The method of claim 7, wherein the analyte is total cholesterol.

11. The method of claim 7, wherein in the step of placing (step (a)), the receptor presses against the skin thereby removing a portion of the blood within the skin.

12. The method of claim 7, wherein in the step of placing (step (a)), the receptor is clamped against the skin thereby removing a portion of the blood within the skin.

13. An apparatus comprising:

a clamp having a first and a second end, the first end comprising one or more than one lever, and the second end comprising two receptor members to receive a sample of skin,

wherein release of the one or more than one lever brings the two receptor members together over the sample of skin,

wherein one of the two receptor members houses one or more than one input fiber optic element for introducing an input electromagnetic radiation (EMR) to the sample of skin, and one or more than one output fiber optic element to remove an output EMR signal after interaction with one or more than one analyte within the sample of skin,

wherein the other of the two receptor members has a reflective base that reflects EMR radiation transmitted through the sample of skin when placed between the two receptor members to the one or more than one output fiber optic element, and

wherein the one or more than one input fiber optic element and the one or more than one output fiber optic element are adjacent to each other within a fiber optic bundle.