Non-invasive bodily fluid withdrawal and monitoring system

• US 6,023,639 A
• Filed: 05/01/1998
• Issued: 02/08/2000
• Est. Priority Date: 05/01/1998
• Status: Expired due to Term

• Current Assignee: Hakki, A-Hamid, Hakky, Said
• Original Assignee: Hakki, A-Hamid, Hakky, Said
• Inventors: Hakky, Said, Hakki, A-Hamid
• Primary Examiner(s): Stright, Jr., Ronald K.
• Assistant Examiner(s): Cho, David J.
• Application Number:
  US09/071,343
• Time in Patent Office: 648 Days
• Field of Search: 604/20, 604/22, 604/289, 604/290, 604/306, 604/310, 604/312, 604/313, 600/309, 600/365, 600/573, 600/578, 600/579, 607/2, 607/75, 424/448, 424/449
• US Class Current: 604/20
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• 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 5/441 Skin evaluation, e.g. for skin disorder diagnosis

Abstract

A system for non-invasively withdrawing and monitoring bodily fluids from the skin of a user is provided. The system apparatus includes a portable hand-held housing (16) having an internal chamber (9). Fluid displacement mechanism (1) is removably coupled to the housing (16) for directing the fluid from the skin into the internal chamber (9). The fluid displacement mechanism (1) has a first end (20) adapted to be located on an outer surface of the skin and an opposing second end (21) located internal the housing (16). Vacuum pump (10) in the housing (16) non-invasively extracts the fluid from the skin and draws the extracted fluid into the internal chamber (9) through the fluid displacement mechanism (1). A monitoring mechanism within the internal chamber (9) monitors the fluid drawn into the chamber (9).

Claims

1. A non-invasive system for withdrawing and monitoring a fluid drawn through a user'"'"'s skin comprising:

(a) a housing having an internal chamber;

(b) fluid displacement means for directing said fluid from the user'"'"'s skin into said internal chamber, said fluid displacement means having a first end positionally located contiguous an outer surface of the user'"'"'s skin and an opposing second end disposed internal said housing;

(c) vacuum generating means in open communication with said internal chamber for generating a negative pressure of a predetermined magnitude therein;

(d) energy generating means disposed within said housing and coupled to said internal chamber for generating energy at a level not greater than that which reduces cohesiveness of cells of a stratum cornium layer of the user'"'"'s skin, said negative pressure in said internal chamber and said generated energy being transmitted through said fluid displacement means to the user'"'"'s skin; and

,

(e) monitoring means within said internal chamber of said housing for monitoring said fluid drawn into said internal chamber.

2. The system as recited in claim 1 where said energy generating means includes

an ultrasonic transducer coupled to said internal chamber for generating ultrasonic energy.

3. The system as recited in claim 1 where said energy generating means includes

electric field generating means in contiguous contact with the user'"'"'s skin for inducing a current therein.

4. The system as recited in claim 2 where said energy generating means further includes electric field generating means in contiguous contact with the user'"'"'s skin for inducing a current therein.

5. A non-invasive system for withdrawing and monitoring a fluid drawn through a user'"'"'s skin comprising:

(a) a housing having an internal chamber;

(b) fluid displacement means for directing said fluid from the user'"'"'s skin into said internal chamber, said fluid displacement means having a first end positionally located contiguous an outer surface of the user'"'"'s skin and an opposing second end disposed internal said housing, said fluid displacement means including a tubular structure coupled to said housing, said tubular structure having a plurality of capillary conduits extending between said first and second ends;

(c) means for non-invasively extracting said fluid from the user'"'"'s skin and for drawing said extracted fluid into said internal chamber through said fluid displacement means, said means for non-invasively extracting said fluid being positioned within said housing; and

,

(d) monitoring means within said internal chamber of said housing for monitoring said fluid drawn into said internal chamber.

6. A non-invasive system for withdrawing and monitoring a fluid drawn through a user'"'"'s skin comprising:

(a) a housing having an internal chamber;

(b) fluid displacement means for directing said fluid from the user'"'"'s skin into said internal chamber, said fluid displacement means having a first end positionally located contiguous an outer surface of the user'"'"'s skin and an opposing second end disposed internal said housing, said fluid displacement means including a tubular structure coupled to said housing, said tubular structure having a plurality of capillary conduits extending between said first and second ends;

said fluid displacement means including a sealing member mounted to a peripheral edge of said first end of said fluid displacement means, said sealing member forming a substantially air-tight seal between said sealing member and the user'"'"'s skin in contact therewith;

(c) means for non-invasively extracting said fluid from the user'"'"'s skin and for drawing said extracted fluid into said internal chamber through said fluid displacement means, said means for non-invasively extracting said fluid being positioned within said housing; and

,

(d) monitoring means within said internal chamber of said housing for monitoring said fluid drawn into said internal chamber.

7. A non-invasive method for withdrawing and monitoring a fluid drawn through a user'"'"'s skin, including the steps of:

(a) providing a housing having an internal chamber, said housing being contiguously applied to a selected portion of the user'"'"'s skin;

(b) applying a negative pressure to the selected portion of the user'"'"'s skin;

(c) applying energy to the selected portion of the user'"'"'s skin substantially simultaneous with said application of said negative pressure to draw fluid into said internal chamber, said energy being applied at a level not greater than that which reduces cohesiveness of cells of a stratum cornium layer of the user'"'"'s skin; and

,

(d) monitoring said fluid to determine at least one predetermined characteristic thereof.

8. The method as recited in claim 7 where the step of applying energy includes the step of applying ultrasonic energy to the selected portion of the user'"'"'s skin.

9. The method as recited in claim 7 where the step of applying energy includes the step of applying an electric field to the selected portion of the user'"'"'s skin.

10. The method as recited in claim 7 where the step of applying energy includes the step of applying ultrasonic energy, and an electric field to the selected portion of the skin.