Non- or minimally invasive monitoring methods using particle delivery methods

• US 6,207,400 B1
• Filed: 09/03/1999
• Issued: 03/27/2001
• Est. Priority Date: 09/04/1998
• Status: Expired due to Fees

• Current Assignee: Powderject Research Limited (Pfizer Inc.)
• Original Assignee: Powderject Research Limited (Pfizer Inc.)
• Inventors: Kwon, Sung-Yun
• Primary Examiner(s): Leary, Louise N.
• Application Number:
  US09/390,068
• Time in Patent Office: 571 Days
• Field of Search: 435/14, 435/4, 435/283.1, 435/25
• US Class Current: 435/14
• CPC Class Codes: A61B 17/545 using a stream or spray of abrasive particles
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2017/00747 Dermatology
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase

Abstract

Methods for sampling an analyte present in a biological system are provided. The methods entail use of particle delivery methods to obtain a sample of an analyte of interest from the system.

Claims

1. A method for sampling an analyte present beneath a target skin or mucosal surface of an individual, said method comprising:

(a) accelerating particles into and/or across said target surface, wherein acceleration of said particles into or across the target surface is effective to allow passage of a fluid sample from beneath the target surface to the target surface, and further wherein said particles are accelerated toward the target surface using a needleless syringe device or a particle-mediated delivery device; and

(b) determining the presence of said analyte in said fluid sample.

2. The method of claim 1 wherein the analyte is a physiologically active material.

3. The method of claim 1 wherein acceleration of the particles into the target surface in step (a) serves to increase the permeability of the target surface.

4. The method of claim 1 wherein the particles are accelerated toward the target surface in step (a) using a needleless syringe device.

5. The method of claim 4, wherein the particles are accelerated toward the target surface at a velocity of about 100 to 2,500 m/sec.

6. The method of claim 1 wherein the particles have a size predominantly in the range of about 0.1 to 250 μ

m.

7. The method of claim 1 wherein the particles are coated with a locally active agent.

8. The method of claim 7, wherein the particles are coated with an osmotically active agent or a pharmacological agent.

9. The method of claim 8, wherein the pharmacological agent is a vasoactive agent or an anti-inflammatory agent.

10. The method of claim 1 wherein the target surface in step (a) has an overall size ranging from about 0.1 to about 5.0 cm².

11. The method of claim 1 wherein the fluid sample comprises interstitial fluid.

12. The method of claim 1 wherein step (b) comprises collecting a sample from the target surface.

13. The method of claim 12, wherein the collection step entails contacting the target surface with an absorbent material.

14. The method of claim 13, wherein the absorbent material is coated with an enzyme that reacts specifically with the analyte to produce a detectable signal.

15. The method of claim 14, wherein the physiologically active material is glucose and the enzyme is glucose oxidase.

16. The method of claim 15, wherein the detectable signal is quantitative and can be correlated with a blood glucose level in the individual.

17. The method of claim 14, wherein the physiologically active material is ethanol and the enzyme is an alcohol oxidase enzyme.

18. The method of claim 17, wherein the detectable signal is qualitative and is indicative of the presence or absence of ethanol in the individual or the detectable signal is quantitative and can be correlated with a blood alcohol level in the individual.

19. The method of claim 12 wherein the sample is collected into a collection means which is contacted with the target surface after the particles are accelerated into said surface.

20. The method of claim 12 wherein the acceleration and collection steps are repeated at least once over the course of a day in order to provide for continual monitoring of the physiologically active material in the individual.

21. The method of claim 1 wherein step (b) comprises contacting the sample which has passed to the target surface with a sensing apparatus that detects the presence or amount of said analyte.

22. A method for use of an inert particulate composition for sampling an analyte present beneath a target skin or mucosal surface of an individual comprising:

(a) accelerating particles of the particulate composition into and/or across said target surface, wherein acceleration of said particles into or across the target surface is effective to allow passage of a fluid sample from beneath the target surface to the target surface, and further wherein said particles are accelerated toward the target surface using a needleless syringe device or a particle-mediated delivery device; and

(b) determining the presence of said analyte in said fluid sample.