Non-or minimally invasive monitoring methods using particle delivery methods

• US 6,482,604 B2
• Filed: 03/12/2001
• Issued: 11/19/2002
• 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:
  US09/803,828
• Publication Number:
  US 20010029957A1
• Time in Patent Office: 617 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 measured quanitity of a powder composition comprising sampling particles, said powder composition comprising size-selected particles of an inert material selected from the group consisting of sugars, soluble or dissolvable polymers, starch, TiO_2, calcium carbonate, phosphate salts, lactic acid and hydroxy apatite.

2. The powder composition of claim 1 wherein the size-selected particles have a size ranging from 0.1 to 250 μ

m.

3. The powder composition of claim 1 wherein the size-selected particles have a size ranging from 10 to 70 μ

m.

4. The powder composition of claim 1 wherein the size-selected particles have a size ranging from 28-53 μ

m.

5. The powder composition of claim 1 wherein the inert material is a sugar.

6. The powder composition of claim 5, wherein the sugar is selected from the group consisting of mannitol, sucrose, lactose and trehalose.

7. The powder composition of claim 6 wherein the sugar is lactose.

8. A cassette containing the powder composition of claim 1.

9. A needleless syringe containing the powder composition of claim 1.

10. A particle-mediated delivery device containing the powder composition of claim 1.

11. Sampling particles, comprising particles of an inert material coated with a locally active agent.

12. The sampling particles of claim 11 wherein the agent is a vasoactive agent or an anti-inflammatory agent.

13. The sampling particles of claim 11 wherein the agent is an osmotically active agent.

14. The sampling particles of claim 11 wherein the particles have a size ranging from 0.1-250 μ

m.

15. The sampling particles of claim 14 wherein the particles have a size ranging from 10-70 μ

m.

16. A needleless syringe containing the sampling particles of claim 11.

17. A particle-mediated delivery device containing the sampling particles of claim 11.

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

(a) creating passages in the target surface sufficient to allow said analyte to flow, exude or otherwise pass from beneath the target surface to the target surface; and

(b) contacting the target surface with a sensing apparatus that detects the presence or amount of said analyte.

19. The method of claim 18 wherein the sensing apparatus is a patch.

20. The method of claim 18 wherein an absorbent material is applied to the target surface during step (b).

21. The method of claim 20 wherein the absorbent material is a hydrogel.

22. The method of claim 20 wherein the absorbent material is applied to the target surface for a time sufficient to allow analyte to equilibrate in the gel prior to detection of the presence or amount of the said analyte.

23. The method of claim 18 wherein the fluid sample passes from beneath the target surface over a period of time.

24. The method of claim 18 wherein step (a) comprises accelerating particles into and/or across said target surface to create said passages and step (b) further comprises collecting a sample from the target surface.

25. The method of claim 24 wherein the sample is collected into a collection means that is contacted with the target surface.

26. The method of claim 25 wherein the sample is collected using an ablated flow path.

27. The method of claim 18 wherein step (b) comprises collecting a sample from the target surface using a collection reservoir comprising a miniaturized etched, ablated or molded flow path.