Hollow microneedle patch

Details Hollow microneedle patch Hollow microneedle patch

2001-06-11

2003-08-05

Jeffery, John A. (Department: 3742)

Surgery

Diagnostic testing

Measuring or detecting nonradioactive constituent of body...

C600S365000, C422S051000, C422S051000, C422S082050, C436S169000

Reexamination Certificate

active

06603987

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to blood monitoring devices, and, more particularly, to a test patch for painlessly obtaining a sample of blood.
BACKGROUND OF THE INVENTION
It is often necessary to quickly and painlessly obtain a sample of blood and perform a quick analysis of the blood. One example of a need for painlessly obtaining a sample of blood is in connection with a blood glucose monitoring system where a user must frequently use the system to monitor the user's blood glucose level.
Those who have irregular blood glucose concentration levels are medically required to regularly self-monitor their blood glucose concentration level. An irregular blood glucose level can be brought on by a variety of reasons including illness such as diabetes. The purpose of monitoring the blood glucose concentration level is to determine the blood glucose concentration level and then to take corrective action, based upon whether the level is too high or too low, to bring the level back within a normal range. The failure to take corrective action can have serious implications. When blood glucose levels drop too low—a condition known as hypoglycemia—a person can become nervous, shaky, and confused. That person's judgment may become impaired and that person may eventually pass out. A person can also become very ill if their blood glucose level becomes too high—a condition known as hyperglycemia. Both conditions, hypoglycemia and hyperglycemia, are both potentially life-threatening emergencies.
One method of monitoring a person's blood glucose level is with a portable, hand-held blood glucose testing device. A prior art blood glucose testing device
100
is illustrated in FIG.
1
. The portable nature of these devices
100
enables the users to conveniently test their blood glucose levels wherever the user may be. The glucose testing device contains a test sensor
102
to harvest the blood for analysis. The device
100
contains a switch
104
to activate the device
100
and a display
106
to display the blood glucose analysis results. In order to check the blood glucose level, a drop of blood is obtained from the fingertip using a lancing device. A prior art lancing device
120
is illustrated in FIG.
2
. The lancing device
120
contains a needle lance
122
to puncture the skin. Some lancing devices implement a vacuum to facilitate the drawing of blood. Once the requisite amount of blood is produced on the fingertip, the blood is harvested using the test sensor
102
. The test sensor
102
, which is inserted into a testing unit
100
, is brought into contact with the blood drop. The test sensor
102
draws the blood to the inside of the test unit
100
which then determines the concentration of glucose in the blood. Once the results of the test are displayed on the display
106
of the test unit
100
, the test sensor
102
is discarded. Each new test requires a new test sensor
102
.
One problem associated with some conventional lancing devices is that there is a certain amount of pain associated with the lancing of a finger tip. Diabetics must regularly self-test themselves several time per day. Each test requires a separate lancing, each of which involves an instance of pain for the user.
Another problem associated with some conventional lancing devices is that the lacerations produced by the lances are larger than necessary and consequently take a greater time to heal. The greater the amount of time for the wound to heal translates into a longer period of time in which the wound is susceptible to infection.
Another problem associated with some conventional blood glucose monitoring devices is that the user's blood physically contacts the elements within the testing unit. Cross-contamination can be a problem if the monitoring device is used by more than one user such as a clinical setting.
SUMMARY OF THE INVENTION
According to one embodiment of the present invention, a test strip is provided for use in the determination of the concentration of a chemical in blood. The test strip comprises an array of microneedles and a test area. Each microneedle is adapted to puncture skin and to draw blood. The test area is in fluid communication with the microneedles. The test area contains a reagent adapted to produce a reaction indicative of the concentration of the chemical in blood.
The above summary of the present invention is not intended to represent each embodiment, or every aspect, of the present invention. Additional features and benefits of the present invention will become apparent from the detailed description, figures, and claims set forth below.


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patent: 6503231 (2003-01-01), Prausnitz et al.
patent: 2002/0155737 (2002-10-01), Roy et al.
patent: 2002/0177764 (2002-11-01), Sohrab
patent: 2003/0045837 (2003-03-01), Delmore et al.
patent: 00/22977 (2000-04-01), None

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