Sweat collection patch

• US 4,756,314 A
• Filed: 05/21/1987
• Issued: 07/12/1988
• Est. Priority Date: 10/28/1985
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Eckenhoff, James B., Theeuwes, Felix
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US07/052,315
• Time in Patent Office: 418 Days
• Field of Search: 128/623, 128/766, 128/760, 604/378
• US Class Current: 600/573
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 5/4266 sweat secretion
• CPC Class Codes: A61F 13/022 having more than one layer with different fluid retention characteristics
• CPC Class Codes: A61F 13/0226 characterised by the support layer
• CPC Class Codes: A61F 13/0246 characterised by the skin-adhering layer
• CPC Class Codes: A61F 2013/00429 for conducting tests

Abstract

An improved fluid collection patch is disclosed which is capable of providing a quantitative indication of the average concentration of an agent in a body fluid during a collection period. The patch covers a predetermined area of a fluid secretory body surface such as the skin or mucous membrane and is provided with means for maintaining the flow of fluid into the patch substantially constant during the collection period. Preferred flow control means comprise an osmotic agent in the fluid flow path separated from the body surface by a semipermeable membrane. In a preferred embodiment the patch is adhesively bonded to the skin to collect sweat.

Claims

1. A fluid collection patch to be placed on the body surface of a subject for determining the presence of an agent in the fluid collected from said body surface during a fluid collection period comprising, in combination:

(a) receptacle means;

(b) agent collection means within said receptacle means for collecting the agent to be detected during the collection period, said agent collection means being adjacent to said body surface;

(c) rate controlling means for maintaining the rate at which body fluid flows through said agent collection means over a substantial portion of said collection period at a substantially constant level below the rate at which body fluid is secreted at the body surface at the collection site, wherein said rate controlling means comprises (i) an osmotic pressure generating solute and (ii) a semipermeable membrane disposed between said solute and said agent collection means, where said agent collection means is disposed in the path of fluid flow between said membrane and said body surface, and said osmotic solute being present in an amount sufficient to maintain the solution produced by osmotic imbibition of water through said semipermeable membrane at the saturation level during the collection period, and said membrane being impermeable to the agent to be collected; and

(d) means for maintaining said agent collection means in fluid transmitting relationship with said body surface during said collection period.

2. The patch of claim 1 further comprising means for increasing the rate at which fluid is secreted through the body surface at the collection site.

3. The patch of claim 1 wherein said fluid is sweat and said body surface is skin.

4. The patch of claim 1 wherein said fluid is secreted through a mucous membrane and said body surface is a mucous membrane.

5. The collection patch of claim 1 further comprising agent binding means in said collecting means.

6. A fluid collection patch to be placed on a body surface of a subject for determining the presence of an agent in the fluid collected from said body surface during a fluid collection period comprising, in combination:

(a) receptacle means;

(b) agent collection means within said receptacle means for collecting the agent to be detected during the collection period;

(c) rate controlling means for maintaining the rate at which body fluid flows into said agent collection means over a substantial portion of said collection period at a substantially constant level below the rate at which body fluid is secreted at the body surface at the collection site, wherein said rate controlling means comprises (i) an osmotic pressure generating solute and (ii) a semipermeable membrane disposed between said solute and said body surface, said osmotic solute being present in an amount sufficient to maintain the solution produced by osmotic imbibition of water through said semipermeable membrane at the saturation level during the collection period, and said membrane being permeable to the agent to be collected; and

(d) means for maintaining said agent collection means in fluid transmitting relationship with said body surface during said collection period.

7. The patch of claim 6 further comprising means for increasing the rate at which fluid is secreted through the body surface at the collection site.

8. The patch of claim 6 wherein said fluid is sweat and said body surface is skin.

9. The patch of claim 6 wherein said fluid is secreted through a mucous membrane and said body surface is a mucous membrane.

10. The collection patch of claim 6 wherein said solute is dispersed through said agent collection means.

11. A fluid collection patch to be applied to a body surface of a subject for determining the presence of an agent in the fluid collected from said body surface during a collection period, comprising:

(a) a fluid impermeable backing member forming a generally concave receptacle open at its body proximal portion;

(b) agent collecting means received within at least a portion of said backing means, said collecting means having a body proximal surface and a body distal surface, the body proximal surface of said collecting means being adapted to be maintained in fluid conducting relationship to the body surface to which the patch is applied;

(c) an osmotic solute within said receptacle, said solute being soluble in the fluid to be collected and present in an amount sufficient to maintain the solution thereof with the fluid to be collected at the saturation level during the collection period;

(d) a semipermeable membrane impermeable to the agent being collected, and disposed between said collecting means and said osmotic solute, where said osmotic solute is disposed between said membrane and said backing such that fluid reaching said osmotic solute must flow through said semipermeable membrane, the thickness of said semipermeable membrane being sufficient to maintain the flow rate of fluid from said body surface to said osmotic solute at a rate below that at which said fluid is produced at said body surface; and

(e) means for maintaining said patch on said body surface during the collection period.

12. The patch of claim 11 further comprising a porous fluid receiving member filling a substantial portion of the remainder of said receptacle and positioned between said agent collecting means and said backing member, and a fluid impermeable means adjacent to said pad and enclosing the side surfaces of said collecting means.

13. The patch of claim 12 further comprising agent binding means in said collecting means.

14. The patch of claim 12 further comprising means for increasing the water permeability of the body surface to which the patch is applied.

15. The collection patch of claim 12 further comprising:

said solute and semipermeable membrane formed into an elementary osmotic pump maintained in juxtaposition to said agent collecting means and said elementary osmotic pump having an agent collecting means proximal side and an agent collecting means distal side,

the outlet of said pump being positioned on the agent collecting means distal side of said elementary osmotic pump and discharging into said porous fluid receiving member.

16. A fluid collection patch to be placed on a body surface of a subject for determining the presence of an agent in the fluid collected during a fluid collection period comprising, in combination:

(a) agent collecting means;

(b) water impermeable receptacle means receiving said collecting means, said receptacle means being adapted when applied to the body of the subject to permit fluid from the body to flow to said collecting means and prevent the escape of fluid from the patch;

(c) rate controlling means for controlling the flow of fluid from the body to the collecting means during the collection period, said rate controlling means comprising (i) an osmotic pressure generating solute dispersed through said collecting means and (ii) a semipermeable membrane permeable to the agent being collected, disposed in the path of fluid flow between said agent collecting means and said body surface, said osmotic solute being present in an amount sufficient to maintain the solution produced by osmotic imbibition of water through said semipermeable membrane at the saturation level during the collection period; and

(d) means for maintaining said agent collecting means in fluid transmitting relationship with said body surface during said collection period.

17. The collection patch of claim 16 wherein said means for maintaining said collection patch on the body surface comprises adhesive means bonding at least the periphery of said patch to the body surface.

18. The collection patch of claim 17 wherein said body surface is skin and said fluid is sweat.

19. The collection patch of claim 17 wherein said adhesive means is an adhesive overlay.

20. The collection patch of claim 17 wherein said adhesive means comprises an adhesive coating on at least a portion of the body proximal surface of said patch.

21. The collection patch of claim 16 further comprising means for increasing the water permeabilty of the body surface at the collection site.

22. A fluid collection patch to be applied to a body surface of a subject for determining the presence of an agent in the fluid collected from said body surface during a collection period, comprising:

(a) a fluid impermeable backing member forming a generally concave receptacle open at its body proximal portion;

(b) agent collecting means received within said backing means, said collecting means having a body proximal surface and a body distal surface, the body proximal surface of said collecting means being adapted to be maintained in fluid conducting relationship to the body surface to which the patch is applied;

(c) an osmotic solute dispersed through said collecting means, said solute being soluble in the fluid to be collected and present in an amount sufficient to maintain the solution thereof with the fluid to be collected at the saturation level during the collection period;

(d) a semipermeable membrane permeable to the agent being collected and disposed on the body proximal surface of said collecting means such that fluid reaching the osmotic solute contained within said collecting means must flow through said semipermeable membrane, the thickness of said semipermeable membrane being sufficient to maintain the flow rate of fluid from said body surface to said osmotic solute at a rate below that at which said fluid is produced at said body surface; and

(e) means for maintaining said patch on said body surface during the collection period.

23. The patch of claim 22 wherein said collecting means substantially fills said receptacle.

24. A fluid collection patch to be placed on a body surface of a subject for determining the presence of an agent in the fluid collected during a fluid collection period comprising, in combination:

(a) agent collecting means;

(b) water impermeable receptacle means receiving said collecting means, said receptacle means being adapted when applied to the body of the subject to permit fluid from the body to flow to said collecting means and prevent the escape of fluid from the patch;

(c) rate controlling means for controlling the flow of fluid from the body to the collecting means during the collection period, said rate controlling means comprising (i) an osmotic pressure generating solute and (ii) a semipermeable membrane impermeable to the agent being collected, disposed between said agent collecting means and said solute, said osmotic solute being present in an amount sufficient to maintain the solution produced by osmotic imbibition of water through said semipermeable membrane at the saturation level during the collection period; and

(d) means for maintaining said agent collecting means in fluid transmitting relationship with said body surface during said collection period.

25. The collection patch of claim 24 further comprising means for increasing the water permeability of the body surface at the site of collection.

26. The collection patch of claim 24 wherein said means for maintaining said collection patch on the body surface comprises adhesive means bonding at least the periphery of said patch to the body surface.

27. The collection patch of claim 26 wherein said adhesive means is an adhesive overlay.

28. The collection patch of claim 26 wherein said adhesive means comprises an adhesive coating on at least a portion of the body proximal surface of said patch.

29. The collection patch of claim 26 wherein said body surface is skin and said fluid is sweat.