Device, System and Method for Modular Analyte Monitoring

• US 20160302707A1
• Filed: 11/16/2015
• Published: 10/20/2016
• Est. Priority Date: 02/27/2008
• Status: Abandoned Application

• Current Assignee: Mon4D, Ltd.
• Original Assignee: Mon4D, Ltd.
• Inventors: Pesach, Benny, Bitton, Gabriel, Nagar, Ron
• Application Number:
  US14/941,923
• Publication Number:
  US 20160302707A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0285 Apparatus for single use
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• 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 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150076 by heating
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150091 by electricity
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15109 : Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15142 : Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/7285 : for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

The present invention relates to a device, system and a method for measuring an analyte and in particular, to such a device, system and method in which analyte from a bodily fluid is measured and/or monitored.

Claims

1-85. -85. (canceled)

86. A system for measuring a blood analyte concentration from a blood sample, the system comprising:

a disposable housing having an opening for receiving said blood sample for measuring said analyte and at least two disposable electrical contacts for performing said measurement; and

wherein said disposable housing comprises a single skin piercing element, a single measuring element for measuring said analyte concentration in blood and a coupling mechanism or attaching said housing over said measuring area; and

a reusable housing having at least two reusable electrical contacts corresponding to said at least two disposable electrical contacts; and

comprising a power source, a controller, a transponder and at least one mechanical actuator for performing and communicating said measurement; and

wherein said reusable housing is associated with said disposable housing over said at least two corresponding reusable electrical contacts and said at least two disposable electrical contacts; and

wherein said at least one mechanical actuator is coupled to and manipulates said single skin piercing element and said single measuring element; and

wherein upon a triggering signal said at least one mechanical actuator manipulates the movement of said single skin piercing element to pierce the skin and then after a given period at least one mechanical actuator manipulates the movement of said single measuring element, from a first position of a piercing area to a second position of said piercing area, such that said measuring element opening wipes said piercing area and samples the blood drawn from said skin piercing area; and

therein triggering the measurement of said analyte concentration in said blood sample within said reusable housing and communicating said measurement to said remote controller; and

wherein said remote controller is further adapted to receive said measurement and to display it in the form of a concentration of said blood analyte.

87. The system of claim 86 wherein said given period is a period that allows the blood to pool about said piercing area forming a blood pooling area.

88. The system of claim 87 wherein said given period is a predetermined period that allows the blood to pool in said blood pooling area.

89. The system of claim 87 wherein said given period is determined by measuring the amount of accumulated blood within said blood pooling area using an optical element.

90. The system of claim 87 wherein said piercing element is adapted for piercing only the dermis layer of the skin.

91. The system of claim 87 wherein said housing further comprises at least one tissue treatment element for improving blood extraction, wherein said treatment element is chosen from the group consisting of:

electrical energy, ultrasound energy, optical energy, acoustic energy, vasodilation drugs, applied heating, massage, mechanical energy, and any combination thereof.

92. The system of claim 91 wherein a remote controller is adapted to control more than a single combination of said disposable and reusable housing.

93. The system of claim 92 wherein the remote controller can communicate said measurement to a second remote controller.

94. The system of claim 92 wherein said remote controller is a cellular phone.

95. The system of claim 92 that is further adapted to provide an alarm if said measurement concentration is out of a certain range.

101. The system of claim 86 wherein said disposable housing has a cylindrical shape with an opening such that it can fit a finger;

and wherein a triggering signal activates said at least one mechanical actuator provided to manipulate the movement of said single skin piercing element to pierce the skin surface of said finger, and after a given period at least one mechanical actuator manipulates the movement of said single measuring element such that said opening of the measuring element accumulates pooled blood sampled from said skin of said finger.

96. A device for measuring a blood analyte concentration from a blood sample, the device comprising:

a disposable housing having an opening for receiving said blood sample for measuring said analyte and at least two disposable electrical contacts for performing said measurement; and

wherein said disposable housing comprises a single skin piercing element, a single measuring element for measuring said analyte concentration in blood and a coupling mechanism for attaching said housing over said measuring area; and

a reusable housing having at least two reusable electrical contacts corresponding to said at least two disposable electrical contacts; and

comprising a power source, a controller, a transponder, and at least one mechanical actuators for performing and communicating said measurement; and

at least one tissue treatment element for improving blood extraction; and

wherein said reusable housing is associated with said disposable housing over said at least two corresponding reusable electrical contacts and said at least two disposable electrical contacts; and

wherein said at least one mechanical actuator is coupled to and manipulates said single skin piercing element and said single measuring element; and

wherein upon a triggering signal said tissue treatment element applies a treatment to the skin to improve local blood perfusion at the tissue volume adjacent to treatment area; and

after a given period of treatment application at least one mechanical actuator manipulates the movement of said single skin piercing element to pierce the skin at the treatment area having improved blood perfusion, such that said measuring element opening accumulates the blood drawn from said skin piercing therein pooling said blood for sampling; and

therein triggering the measurement of said analyte concentration in said pooled blood sample within said reusable housing and communicating said measurement to said remote controller; and

wherein said remote controller is further adapted to receive said measurement and to display it in the form of a concentration of said blood analyte.

97. The device of claim 96 wherein said treatment element is chosen from the group consisting of:

electrical energy, ultrasound energy, optical energy, acoustic energy, vasodilation drugs, applied heating, massage, and mechanical energy.

98. The device of claim 97 wherein said piercing element is adapted for piercing only the dermis layer of the skin.

99. The device of claim 96 wherein said disposable housing includes a cavity to be attached to measuring area to confine said pooled blood;

and wherein upon triggering signal said at least one mechanical actuator manipulates the movement of said single skin piercing element to pierce said skin; and

wherein said treatment is applied by said coupling mechanism over said measuring area such that said coupling mechanism squeezes said skin at the piercing area such that the drawn blood is confined within said cavity; and

wherein said at least one mechanical actuator manipulates the movement of said opening of the measuring element to said cavity, such that the blood drawn out of said skin piercing is accumulated by said opening.

100. The device of claim 99 wherein said piercing element is adapted for piercing only the dermis layer of the skin.

102. A method for measuring a blood analyte concentration from a blood sample comprising:

coupling an analyte measuring device over a measuring area with a coupling mechanism wherein said analyte measuring device comprises a disposable housing having an opening for receiving said blood sample for measuring said analyte and at least two disposable electrical contacts for performing said measurement; and

wherein said disposable housing comprises a single skin piercing element, a single measuring element for measuring said analyte concentration in blood; and

performing and communicating said measurement with a reusable housing having at least two reusable electrical contacts corresponding to said at least two disposable electrical contacts; and

comprising a power source, a remote controller, a transponder and at least one mechanical actuator; and

wherein performing said measurement comprises;

associating said reusable housing with said disposable housing over said at least two corresponding reusable electrical contacts and said at least two disposable electrical contacts; and

wherein said at least one mechanical actuator is coupled to and manipulates said single skin piercing element and said single measuring element; and

receiving a triggering signal to activate said piercing element wherein said at least one mechanical actuator manipulates the movement of said single skin piercing element to pierce the skin and then after a given period at least one mechanical actuator manipulates the movement of said single measuring element, from a first position of a piercing area to a second position of said piercing area, such that said measuring element opening wipes said piercing area and samples the blood drawn from said skin piercing area; and

measuring said analyte concentration in said blood sample within said reusable housing; and

wherein said measured analyte concentration is communicated to said remote controller; and

wherein said remote controller is further adapted to receive said measurement and to display it in the form of a concentration of said blood analyte.

103. The method of claim 102 wherein said given period is selected from the group consisting of:

a predetermined period that allows the blood to pool in said blood pooling area;

is determined by measuring the amount of accumulated blood within said blood pooling area using an optical element;

or according to a predefined schedule with said controller.

104. The method of claim 102 wherein said piercing element is adapted for piercing only the dermis layer of the skin.

105. The method of claim 104 wherein said housing further comprises at least one tissue treatment element for improving blood extraction, wherein said treatment element is chosen from the group consisting of:

electrical energy, ultrasound energy, optical energy, acoustic energy, vasodilation drugs, applied heating, massage, mechanical energy, and any combination thereof.

106. The method of claim 102 wherein measurement is carried said remote controller is adapted to control more than a single combination of said disposable and reusable housing.

107. The method of claim 105 adapted to perform a sequence of a plurality of measuring elements.