Integrated system including medication delivery pen, blood...

Surgery – Computer assisted medical diagnostics

Reexamination Certificate

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Details

C604S187000

Reexamination Certificate

active

06192891

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The subject invention relates to a diagnostic and medication delivery system having a medication delivery pen, blood monitoring device and a lancer removably mounted in a common housing.
2. Description of Related Art
Home diabetes therapy requires the patient to carry out a prescribed regimen that involves self-testing blood glucose levels and administering an appropriate dose of insulin. Insulin has traditionally been injected by a hypodermic syringe, which suffers from numerous drawbacks. For example, syringes are not preloaded with medication, requiring the user to carry a separate medical vial. Syringes also require a degree of dexterity and sufficient visual acuity on the part of the patient to line up the needle of the syringe with the rubber septum on the medical vial and to ensure that the syringe is loaded with the proper dosage. As a result, unintentional needle pricks commonly occur.
To overcome the drawbacks of syringes, medication delivery pens have been developed, which facilitate the self-administration of medication such as insulin. Such delivery pens use prepackaged insulin and may be used repeatedly until the medication is exhausted. Mechanical and electronic pens are available to the patient. Electronic pens incorporate electronic circuitry that sets and/or indicates the appropriate dosage of insulin and stores data for subsequent downloading such as the time, date, amount of medication injected, etc.
Glucose levels are monitored at periodic intervals to determine when another insulin injection should be taken or to determine how the user is responding to prior injections. The patient monitors blood levels by lancing a portion of the body with a lancer to take a blood sample. The blood sample is placed on a test strip that contains appropriate reagents for creating the chemical reactions necessary to measure glucose levels, which is subsequently analyzed by the blood glucose monitor. Typically, the patient then manually records the results, the time and date in a log book. To monitor glucose levels the patient is required to have available a lancer, test strips and a blood glucose monitor.
The self-treatment of diabetes therefore requires the patient to carry at least three devices: a medication delivery pen, a blood glucose monitor, and a lancer, as well as ancillary items such as test strips, lancets and needles. This can be inconvenient, cumbersome to use, etc.
A number of patents disclose systems that attempt to allow a patient to more conveniently perform the requisite procedures for treating diabetes. More particularly, U.S. Pat. No. 5,279,294 to Anderson et al. (“Anderson”) discloses a portable unit that includes a glucose monitor and a lancer. The monitor and lancer are integrated in the housing. The lancer is not an independent component operably distinct from the housing. Rather, the housing includes a spring-actuated hammer for driving a disposable lancet. Since the lancer is integrated with the housing, it cannot be removed and used separately from the housing. U.S. Pat. No. 5,536,249 to Castellano et al. (“Castellano”) discloses a medication delivery pen that is integrated with a blood glucose monitor. The pen and monitor are not independent units and thus cannot be used separately from one another.
While the above described systems facilitate the self-administration and monitoring of medication, there is a need for additional features and improvements for such systems. For example, neither of the known systems provide a single unit that integrates all the primary components (i.e., medication delivery pen, blood monitor and lancer) necessary to administer medication and monitor blood glucose levels. Moreover, these systems can be cumbersome to use because the components are not fully detachable from one another and thus each component cannot be used separately from the others at the appropriate point in the treatment process.
SUMMARY OF THE INVENTION
The subject invention relates to a portable diagnostic and medication delivery system that includes a housing and a monitor disposed in the housing for monitoring a characteristic of a bodily fluid sample obtained from an individual. A medication delivery pen and a lancer are each removably mounted to the housing. The monitor, which may be integrated into the housing, may monitor blood glucose levels, for example, and the pen may be employed for the delivery of insulin.
In accordance with one aspect of the invention, the housing has a first compartment adapted to receive and store the medication delivery pen and a second compartment adapted to receive and store the lancer. The first and second compartments may be integrally formed with and embedded in the housing.
In accordance with another aspect of the invention, a data port is located on the housing for downloading the characteristics of the bodily fluid. In those cases where an electronic medication delivery pen is employed, the data port may also receive and download information from the pen. Alternatively, a second data port may be used to download the information from the pen.
In accordance with another aspect of the invention, the monitor includes a display located on an inner surface of the second compartment so that the monitor is protected when the lancer is stored in the second compartment.
In accordance with yet another aspect of the invention, the housing further includes a third compartment adapted to store ancillary items such as test strips, lancets, and needles.
In accordance with another aspect of the invention, the first and second compartments include portions that extend internal to the housing for receiving and protecting a needle of the medication delivery pen and a lancet of the lancer, respectively.
In accordance with still another aspect of the invention, a diagnostic and medication delivery system is provided which includes a housing that has a first compartment adapted to receive and store a medication delivery pen and a second compartment adapted to receive and store a lancer. A monitor is integrated in the housing for monitoring a characteristic of a sample of a bodily fluid.


REFERENCES:
patent: 5593390 (1997-01-01), Castellano et al.

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