Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
2001-05-18
2003-01-07
Brinson, Patrick (Department: 3752)
Surgery
Diagnostic testing
Liquid collection
C600S576000, C600S578000, C606S013000, C606S009000
Reexamination Certificate
active
06503209
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The subject invention relates to a focused energy blood withdrawal and analysis system.
Further, the subject invention relates to a non-invasive focused energy blood withdrawal and analysis system which permits microscopic openings or holes to be formed into the epidermal layer of a patient in a substantially rapid manner with a minimization of dermal nerve stimulation.
Still further, the subject invention directs itself to a blood withdrawal and analysis system wherein the major components are located within a hand-held portable housing and transmit parameters being measured to an external display.
The subject invention relates to a non-invasive focused energy blood withdrawal and analysis system. In particular, the present invention directs itself to a hand-held, portable system for creating microscopic incisions in an epidermal layer. More particularly, this invention is directed towards a system for drawing blood from the incision and analyzing the drawn blood sample for various blood components. More particularly, this invention directs itself to a blood withdrawal system using a focused energy beam to incise the epidermal layer.
Further, the hand-held system has a vacuum pump mounted within the portable housing in order to draw a blood sample from the incision in the epidermal layer. Additionally, this invention directs itself to a blood analysis system having sensor elements mounted within the housing for substantially instantaneous analysis of the blood sample.
Still further, this invention is directed to a non-invasive focused energy blood withdrawal and analysis system which includes an energy source located within the housing for generating an energy beam with the energy beam being focused on an epidermal layer to create a microscopic opening in the epidermal layer.
Still further, the subject invention relates to a non-invasive focused energy blood withdrawal and analysis system which includes a logic processing unit coupled to an energy source, all of which are mounted within a housing.
Additionally, the subject invention relates to a non-invasive focused energy blood withdrawal and analysis system which combines a vacuum pump, a logic processing unit, and an energy source within a housing which is portable in nature and adapted to be hand-held.
Further, the subject invention pertains to a non-invasive focused energy blood withdrawal and analysis system which includes an energy source, a vacuum pump, and a slide located in the fluid path of a blood sample withdrawn from an epidermal layer upon actuation of the energy source under control of the logic processing unit.
Additionally, the subject invention relates to a non-invasive focused energy blood withdrawal and analysis system which includes a display for displaying parameters of blood withdrawn through the epidermal layer where the display is coupled to a logic processing unit and a power source.
More in particular, this invention is directed to a non-invasive focused energy blood withdrawal and analysis system where a slide for collecting blood being drawn from an epidermal layer is removably mounted within a housing and is placed in the fluid path of the blood sample being drawn by a vacuum pump mounted within the housing.
Still further, the subject invention relates to a non-invasive focused energy blood withdrawal and analysis system which provides for a pulsed energy wave, delivered in a repeated programmed manner, in order to precisely control the diameter of an opening or hole to be made in the skin and further to control the depth of the hole being generated.
Further this invention provides for a non-invasive focused energy blood withdrawal and analysis system where focused energy in the form of a laser, a sonic beam or an electrical current is used to incise an epidermal layer whereby the focused layer transmission components are located in a portable housing.
2. Prior Art
Blood withdrawal and analysis systems are known in the art. In general, such prior art systems include some type of focused energy for incising the epidermal layer. In many instances, however, the blood to be analyzed flows through the incision of the epidermal layer under the body's own blood pressure which is a slow and inefficient process. Further, prior art analysis systems often draw the blood sample within permanent analysis chamber. Not only is the preparation of a special chamber time consuming and generally inefficient, but it is also relatively unsanitary. It is a purpose of the subject invention to provide a combination of elements making up a hand-held, portable blood withdrawal and analysis system which allows for the use of both a focused energy beam to incise an epidermal layer, and an adjustable vacuum pump for applying variable suction to the incision on the epidermis. Further, the subject invention provides a removable dry slide positioned in the flow of the blood sample for collecting the blood sample for analysis. The removable slide is replaceable within the housing subsequent to a particular test being completed.
One such prior art withdrawal and analysis system is shown in U.S. Pat. No. 5,617,851. This reference is directed to an ultrasonic transdermal system for withdrawing fluid from an organism and determining the concentration of a substance in the fluid. This system includes an ultrasonic transducer for generating pulses to be focused onto the skin of an organism. The trauma of the ultrasonic pulse causes the dermal-epidermal junction membrane and the capillary endothelial joints to open, allowing blood to be drawn. Substances to be detected in the blood are sensed by a substance sensing transducer, the output of the transducer being analyzed by a test data processor. This system does not include an additional vacuum pump for drawing the blood from the incision made in the skin.
Another such prior art blood withdrawal system is shown in U.S. Pat. No. 5,131,403. This reference is directed to a method for obtaining blood using iontrophoresis. This system uses electric current to penetrate the epidermal layer of a patient. The system, however, does not include an adjustable vacuum for aiding in the drawing of blood through the microscopic puncture in the skin.
U.S. Pat. No. 5,989,409 shows a prior art system directed to a method for glucose sensing. This system includes a plurality of electrodes for generating an electrical current to be sent through the skin of a patient, thereby drawing molecules, including glucose, through the patient's skin and into a hydrogel patch. This reference does not include sensor elements allowing for the sensing of a variety of chemical compounds in blood, nor does it include a vacuum pump for expeditiously drawing blood through the skin.
U.S. Pat. No. 5,954,685 shows a prior art system directed to an electrochemical sensor with a dual purpose electrode. This system utilizes a pair of electrodes to generate an electrical current in a subject's skin. Blood is thus drawn through the skin and collected for analysis in a reservoir system. The system, however, does not include a vacuum pump for aiding in the drawing of the blood through the skin.
Another prior art blood withdrawal system is shown in U.S. Pat. No. 5,895,362. This reference is directed to transdermal transport using ultrasonic standing waves. The system utilizes a sonic generator for generating an ultrasonic standing wave of a given frequency and distributing the wave over the surface of the skin. The system does not use a focused energy beam for incising of the skin, nor does it include a vacuum pump for aiding in the drawing of the blood from the epidermal layer.
None of the prior art provides for a combination of elements forming a blood analysis and withdrawal system which is hand-held, portable, includes a focused energy beam for creating a microscopic incision in the epidermal layer coupled with a vacuum pump for aiding in the drawing of the blood to be analyzed through the incision. Additionally, none of the prior art Patents provide for a remo
Hakki A-Hamid
Hakky Said I.
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