Glucose medical monitoring system

• US 4,637,403 A
• Filed: 06/14/1985
• Issued: 01/20/1987
• Est. Priority Date: 04/08/1985
• Status: Expired due to Term

• Current Assignee: Arthur R. Kudd, Judson M. Dayton, Queststar Medical, Inc.
• Original Assignee: Garid, Inc.
• Inventors: Ginnow-Merkert, Hartmut, Anderson, Paul J., Garcia, Fernando S., Hudson, Bertram J.
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US06/744,539
• Time in Patent Office: 585 Days
• Field of Search: 128/303 R, 128/329 R, 128/760, 128/763, 128/767, 128/770, 128/771, 128/633, 128/636, 128/637, 73/864.87, 73/61.1 C, 356/39-42
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150404 Specific design of proximal end
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

Hand-held shirt-pocket portable medical diagnostic system for checking measurement of blood glucose, urea nitrogen, hemoglobin, blood components or other body qualities. The system includes the engagement of a disposable needle or lance probe package which carries a chemical reagent strip such as blood reacting chemistry. The system includes a pen structure having a visual readout, a microcomputer, and photosensing circuitry which measures the change of color of the blood reacting chemistry of the disposable probe package. The pen also includes a spring arrangement for actuating a needle or lance into the skin for transferring blood from a finger or other area to the chemical reagent strip. A disposable probe structure package includes configurations for transferring of the blood to the reagent strip or the reagent strip to the blood. The pen can also create a vacuum about a time period that the needle is penetrating the skin. The system includes a verification sequence of the electronics, the chemistry of an unused disposable probe package, the presence of blood sample and multiple readings to average results. The system can also be provided with provisions for storing a plurality of readings, communicating with a personal computer, and can act as an alarm and chime to indicate time periods for blood sensing.

Claims

1. Hand-held pocketable measurement system for extraction and analysis of blood in a body, comprising:

pocketable housing member including a spring actuated hammer means in said housing member, optical measurement means including a light source and a light sensor for measuring light emanating from said source and reflected by blood reagent chemistry having a color optical characteristic proportional to the component of the liquid to be measured when in contact with the liquid, said optical measurement means generating an electrical signal responsive to a color change of said blood reagent chemistry and therefore also to the component to be measured, display means responsive to said electrical signal to provide a visual readout representative of the analysis on a display means in said housing member, and channel means for removably receiving a disposable diagnostic unit; and

,

b. disposable diagnostic unit including a unit housing with opposing tabs for slidably and removably engaging said channel means, means supporting said blood reagent chemistry in said unit housing in a position to be sensed by said optical measurement means when said unit housing is engaged within said channel means, said blood reagent chemistry having said color optical characteristics responsive to the component of the liquid to be measured, spring mounted lance means in said unit housing and positioned to be struck by said hammer means, a hole in said unit housing below said lance means, said lance means moving when struck to pierce the body to allow fluid to flow therefrom, and wick means between said lance means and said blood reagent chemistry means for transporting said fluid flowing from within the body to said reagent means, thereby resulting in a color change yielding a responsive optical characteristic which is read by said optical measurement means.

2. System according to claim 1 further comprising cocking means slidably mounted on said housing member for cocking for said hammer means.

3. System according to claim 1 further comprising pushbutton means on a side of said housing member for releasing said hammer means.

4. System according to claim 1 wherein said wick means is positioned across a portion of said base of said unit housing to be penetrated by said lance means when said lance means is struck by said hammer means.

5. System according to claim 1 wherein said wick means selectively transports components of said fluid and provides a filtering action between said fluid and said blood reagent chemistry.

6. System according to claim 1 wherein said blood reagent chemistry is read from a back side by said optical measurement means.

7. Hand-held pocketable measurement system for extraction and analysis of blood in a body, comprising:

a. pocketable housing member including a spring actuated hammer means in said housing member, optical measurement means including a light source and a light sensor for measuring light emanating from said source and reflected by blood reagent chemistry having a color optical characteristic responsive to the component of the liquid to be measured when in contact with the liquid, said measurement means generating an electrical signal proportional to a color change of said blood reagent chemistry and therefore also to the component to be measured, display means proportional to said electrical signal to provide a visual readout representative of the analysis on a display means in said housing member, and channel means for removably receiving a disposable diagnostic unit; and

,

b. disposable diagnostic unit including a unit housing with opposing tabs for slidably and removably engaging said channel means, means supporting said blood reagent chemistry in said unit housing in a position to be sensed by said optical measurement means when said unit housing is engaged within said channel means, said blood reagent chemistry having said color optical characteristic responsive to the component of the liquid to be measured, spring mounted lance means in said unit housing and positioned to be struck by said hammer means, a hole in said unit housing below said lance means, said lance means moving when struck to pierce the body to allow fluid to flow therefrom, wick means between said lance means and said blood reagent chemistry for transporting said fluid flowing from within the body to said blood reagent chemistry, and red blood cell filter means for filtering of red blood cells whereby said blood reagent chemistry undergoes a color change yielding a proportional optical characteristic which is read by said optical measurement means from a back side thereof.