WO2006065901A1 - Multi-contact connector assembly for a sensor-dispensing instrument - Google Patents

Multi-contact connector assembly for a sensor-dispensing instrument Download PDF

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Publication number
WO2006065901A1
WO2006065901A1 PCT/US2005/045236 US2005045236W WO2006065901A1 WO 2006065901 A1 WO2006065901 A1 WO 2006065901A1 US 2005045236 W US2005045236 W US 2005045236W WO 2006065901 A1 WO2006065901 A1 WO 2006065901A1
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WO
WIPO (PCT)
Prior art keywords
connector
sensor
housing
housing connector
base
Prior art date
Application number
PCT/US2005/045236
Other languages
French (fr)
Inventor
Russell J. Micinski
Original Assignee
Bayer Healthcare Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer Healthcare Llc filed Critical Bayer Healthcare Llc
Publication of WO2006065901A1 publication Critical patent/WO2006065901A1/en

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/4875Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48757Test elements dispensed from a stack

Definitions

  • the present invention generally relates to a multi-contact connector assembly for a sensor-dispensing instrument and, more particularly, to a multi-contact connector assembly that is adapted to be used to determine at least one analyte concentration in a fluid such as, for example, blood glucose.
  • test sensors are used to test the sample of blood.
  • a test sensor contains biosensing or reagent material that will react with blood glucose.
  • the testing end of the sensor is adapted to be placed into the fluid being tested, for example, blood that has accumulated on a person's finger after the finger has been pricked.
  • the fluid is drawn into a capillary channel that extends in the sensor from the testing end to the reagent material by capillary action so that a sufficient amount of fluid to be tested is drawn into the sensor.
  • the fluid then chemically reacts with the reagent material in the sensor resulting in an electrical signal indicative of the glucose level in the fluid being tested is supplied to contact areas located near the rear or contact end of the sensor.
  • a multi-contact connector assembly is adapted to be used in a sensor-dispensing instrument that contains a plurality of electrochemical test sensors.
  • the multi-contact connector assembly comprises at least two semiconductor probes, a housing connector, at least two electrical leads, a base connector, and a moveable mechanism.
  • the housing connector forms at least one housing opening.
  • the at least one housing opening is adapted to receive the at least two semiconductor probes.
  • the at least two electrical leads are coupled to the housing connector and adapted to contact a respective one of the at least two semiconductor probes.
  • the at least two electrical leads may be coupled to at least one mounting pad to hold the at least two electrical leads in place and keep them separate.
  • the base connector is coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors. At least one of the base connector and the housing connector is adapted to move between a first position and a second position.
  • the moveable mechanism is coupled to at least one of the housing connector and the base connector. The moveable mechanism is adapted to move at least one of the base connector and the housing connector between the first position and the second position.
  • the housing connector and the base connector are adapted to be coupled in a first position so as to hold one of the plurality of test sensors.
  • the housing connector and the base connector are adapted to be coupled in a second position so as to allow the test sensor to be removed therefrom.
  • a sensor-dispensing instrument is adapted to •determine an analyte concentration.
  • the sensor-dispensing instrument comprises a plurality of electrochemical test sensors, a cartridge containing the plurality of electrochemical test sensors, and a multi-contact connector assembly.
  • the multi-contact connector assembly comprises at least two semiconductor probes, a housing connector, at least two electrical leads, a base connector, and a moveable mechanism.
  • the housing connector forms at least one housing opening.
  • the at least one housing opening is adapted to receive the at least two semiconductor probes.
  • the at least two electrical leads are coupled to the housing connector and adapted to contact a respective one of the at least two semiconductor probes.
  • the at least two electrical leads may be coupled to at least one mounting pad to hold the at least two electrical leads in place and keep them separate.
  • the base connector is coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors.
  • At least one of the base connector and the housing connector is adapted to move between a first position and a second position.
  • the moveable mechanism is coupled to at least one of the housing connector and the base connector. The moveable mechanism is adapted to move at least one of the base connector or the housing connector between the first position and the second position.
  • the housing connector and the base connector are adapted to be coupled in a first position so as to hold one of the plurality of test sensors, and the one of the plurality of test sensors is adapted to contact the at least two semiconductor probes to assist in determining the analyte concentration.
  • the housing connector and the base connector are adapted to be coupled in a second position so as to allow the test sensor to be removed therefrom.
  • a sensor-dispensing instrument is used to determine an analyte concentration.
  • a sensor-dispensing instrument is provided that includes a plurality of electrochemical test sensors, a cartridge containing the plurality of electrochemical test sensors, and a multi-contact connector assembly.
  • the multi-contact connector assembly comprises at least two semiconductor probes, a housing connector, at least two electrical leads, a base connector, and a moveable mechanism.
  • the housing connector forms at least one housing opening.
  • the at least one housing opening is adapted to receive the at least two semiconductor probes.
  • the at least two electrical leads are coupled to the housing connector and adapted to contact a respective one of the at least two semiconductor probes.
  • the at least two electrical leads may be coupled to at least one mounting pad to hold the at least two electrical leads in place and keep them separate.
  • the base connector is adapted to be coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors.
  • the moveable mechanism is adapted to be coupled to at least one of the housing connector and the base connector. At least one of the base connector and the housing connector is placed in a first position.
  • One of the plurality of test sensors is repositioned from the cartridge to the sensor-receiving opening such that one of the plurality of test sensors contacts the at least two semiconductor probes to assist in determining the analyte concentration.
  • At least one of the base connector and the housing connector is moved to a second position from the first position via the moveable mechanism.
  • a fluid with at least one analyte is placed on the one of the plurality of test sensors. The concentration of the at least one analyte is determined.
  • FIG. 1 is a perspective view of a sensor-dispensing instrument in the open position showing a sensor pack being inserted according to one embodiment.
  • FIG. 2a is a front view of a disposable cartridge with a plurality of stacked test sensors according to one embodiment.
  • FIG. 2b is a front view of a sensor-dispensing instrument according to one embodiment that is adapted to receive the cartridge of FIG. 2a.
  • FIG. 3a is a test sensor including a lid according to one embodiment.
  • FIG. 3b is the test sensor of FIG. 3a without the lid.
  • FIG. 4a is an inverted and exploded perspective view of a multi-contact connector assembly according to one embodiment of the present invention before being coupled to a base connector.
  • FIG. 4b is the perspective view of a multi-contact connector assembly of FIG. 4a.
  • FIG. 4c is an internal perspective view of a sensor-dispensing instrument according to one embodiment depicting the multi-contact connector assembly of FIG. 4b.
  • FIG. 5a, 5b are end views of the multi-contact connector assembly of FIG. 4b in a first position.
  • FIG. 5c, 5d are end views of the multi-contact contactor assembly of FIG. 4b in a second position.
  • FIG. 6 is an internal view of a semiconductor probe according to one embodiment used in a multi-contact connector assembly.
  • FIG. 7a is a bottom view of a housing connector of FIG. 4b.
  • FIG. 7b, 7c are perspective views of the housing connector with a plurality of semiconductor probes of FIG. 4.
  • FIG. 8a is a top view of the base connector of FIG. 4b.
  • FIG. 8b is a top perspective view of the base connector of FIG. 4b.
  • FIG. 8c is a bottom perspective view of the base connector of FIG. 4b.
  • FIG. 9 is a perspective view of the sensor-dispensing device of FIG. 4c further including a moveable mechanism being a pusher according to another embodiment.
  • the present invention is directed to a multi-contact connector assembly to be used in a sensor-dispensing instrument that contains a plurality of electrochemical test sensors.
  • the electrochemical test sensors are used to determine concentrations of at least one analyte in a fluid.
  • Analytes that may be determined using the multi-contact connector assembly of the present invention include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin AjC, fructose, lactate, or bilirubin.
  • the present invention is not limited, however, to determining these specific analytes and it is contemplated that other analyte concentrations may be determined.
  • the analytes may be in, for example, a whole blood sample, a blood serum sample, a blood plasma sample, or other body fluids like ISF (interstitial fluid) and urine.
  • the plurality of test sensors is typically stored in a disposable cartridge.
  • the plurality of test sensors may be stored in a sensor pack where the test sensors are individually packaged in sensor cavities (e.g., a blister-type pack).
  • An example of a disposable cartridge 10 being placed in a sensor-dispensing instrument 20 is depicted in FIG. 1.
  • the disposable cartridge 10 is an example of a blister-type pack.
  • the cartridge 10 includes a plurality of test sensors 12 that is individually stored in a respective one of sensor cavities 14. It is contemplated that other sensor packs that individually hold the sensors may be used.
  • the disposable cartridge 10 of FIG. 1 is further described at U.S. Publication No. 2003/0032190 that published on February 13, 2003 and is entitled "Mechanical Mechanism for a Blood Glucose Sensor- Dispensing Instrument.”
  • the plurality of test sensors may be stacked in a disposable cartridge such as shown in FIG. 2a.
  • a disposable cartridge 50 includes a housing 52 and a plurality of stacked test sensors 54 that are moved in the direction of arrow A via a spring 56.
  • the cartridge 50 also includes a plurality of seals 58a,b that protects the stacked test sensors 54 from humidity.
  • the test sensors 54 one at a time, exit the cartridge 50, via opening 60.
  • the disposable cartridge 50 may be stored in a sensor-dispensing instrument 70 of FIG. 2b. It is contemplated that other cartridges besides cartridges 10, 50 may be used.
  • the cartridges 10, 50 of FIGs. 1 and 2a may vary in the number of test sensors that are included so as to address the needs of different users. Typically, the cartridges contain from about 10 to about 50 sensors and, more specifically, contain from about 25 to about 40 sensors. Because of limited shelf-and use-life of the test sensors, it is envisioned that a user who tests infrequently would likely desire a cartridge having less test sensors as opposed to a user who tests more frequently.
  • the test sensors to be used in the cartridges are typically provided with a capillary channel that extends from the front or testing end of the sensors to biosensing or reagent material disposed in the sensor.
  • fluid e.g., blood that is accumulated on a person's finger after the finger has been pricked
  • a portion of the fluid is drawn into the capillary channel by capillary action.
  • the fluid then chemically reacts with the reagent material in the sensor so that an electrical signal indicative of the analyte (e.g., glucose) level in the fluid being tested is supplied and subsequently transmitted to an electrical assembly.
  • Reagent material that may be used to determine the glucose concentration include glucose oxidase.
  • reagent material may be used to determine the glucose concentration such as glucose dehydrogenase. It is further contemplated that other reagent material may be used to assist in determining glucose such as, for example, pyrrolo- quinoline quinone glucose dehydrogenase and potassium ferricyanide.
  • the selected reagent may influence items such as the amount of fluid needed and the length of time needed to perform the testing to determine the analyte concentration.
  • FIGs. 3a, 3b depict a test sensor 70 that includes a capillary channel 72, a lid 74, and a plurality of electrodes 76, 78, and 80.
  • the plurality of electrodes includes a counter electrode 76, a detection electrode 78, and a working (measuring) electrode 80.
  • the test sensor 70 includes a fluid-receiving area 82 that contains reagent. The operation of fluid-receiving area with reagent and the electrodes on the test sensors is known to those skilled in the art and will therefore not be described in further detail.
  • the plurality of test sensors is adapted to auto-calibrate themselves. Having test sensors that auto-calibrate is advantageous because it minimizes the parts needed in the sensor-dispensing instrument. Additionally, having auto- calibration may be desirable because it eliminates the need for a user to enter information about the product lot number of the test sensors so as to perform the correct program associated with the product lot number. It is contemplated, however, that the plurality of test sensors may not have the ability to auto-calibrate themselves.
  • a multi-contact connector assembly 100 is shown according to one embodiment.
  • the multi-contact connector assembly 100 is adapted to make a connection between the test sensor with reagent and the electronic system of the sensor- dispensing instrument.
  • the software located in the sensor-dispensing instrument uses the electrical signals to output at least one analyte concentration of the fluid (e.g., a blood glucose level).
  • the multi-contact connector assembly 100 comprises at least two semiconductor probes 102, a housing connector 104, at least two electrical leads 103, a base connector 106, and a moveable mechanism 108.
  • the multi-contact connector assembly 100 of FIGs. 4 and 5 includes exactly three semiconductor probes 102a-c and three corresponding electrical leads 103a-c. It is contemplated that the multi-contact connector assembly may have exactly two semiconductor probes or may have four or more semiconductor probes. As shown in FIGs. 4b and 5, each of the semiconductor probes 102a-c is fixed in the housing connector 104 and positioned to make contact with a test sensor.
  • the semiconductor probe 102 may be desirably formed to contain a spring 105 so as to maintain an improved connection between the semiconductor probes ' 102a-c and the test sensors.
  • the barrel 107 of the semiconductor probe 102 encases a spring 105.
  • a moveable plunger 109 is located on the end of the semiconductor probe 102 that contacts the test sensor (e.g., test sensor 12).
  • the plunger 109 moves up into the barrel 107 in the direction of arrow 113 in FIG. 6, thereby compressing the spring 105.
  • the compressed spring 105 correspondingly exerts a downward pressure on the plunger 109 so that the semiconductor probe 102 remains generally coplanar with the test sensor 12, thereby enhancing the likelihood that the semiconductor probe 102 remains in contact with the test sensor 12.
  • the components of the semiconductor probes 102a-c may be made of different materials, but are typically made of metal.
  • a material that may be used in forming the barrel 107 of the semiconductor probes 102 is gold-plated nickel silver. It is contemplated that materials such as passivated stainless steel may be used in forming the spring 105.
  • the plunger 109 may be made of gold-plated, full-hard beryllium copper. Additionally, the plurality of semiconductor probes may be shaped differently than depicted in FIGs. 4 and 6.
  • the electrical leads 103 are adapted to communicate with an electronic PC board. In such an embodiment, the electrical leads 103 may extend through apertures formed in the electronic PC board.
  • the electrical leads may be held in place by mounting pads 111, such as shown in FIGs. 4a,b. Additionally, the mounting pads 111 assist in keeping the electrical leads 103 separated from each other. [0039] As shown in FIGs. 4a,b and 7, the housing connector 104 forms a plurality of housing openings or apertures 110a-c that are sized to accept a respective semiconductor probe 102a-c. The semiconductor probes 102a-c are shown in the housing openings 110a-c in FIG. 4b. It is contemplated that the housing connector may have less openings than depicted in FIGs. 4a,b.
  • the housing connector 104 may have at least one opening that receives the semiconductor probes 102a-c. Such embodiments with fewer openings are often less desirable because of the need to electrically isolate the semiconductor probes 102a-c from each other. It is also contemplated that the housing openings 110 may be shaped differently than depicted in FIGs. 4 and 7.
  • the housing connector 104 also includes a plurality of bosses 112.
  • the bosses 112 are adapted to snap into corresponding apertures formed in the electronic PC board of the sensor- dispensing instrument. It is contemplated that the multi-contact connector assembly may be installed in a different manner to the electronic PC board.
  • the housing connector 104 further includes a plurality of base-connecting receiving portions 114, an extension 116, and a plurality of generally triangular-shaped plugs 118. Each of the receiving portions 114 forms an aperture 114a. As shown in FIGs. 4 and 7, the apertures 114a are sized to receive a respective one of a plurality of posts 130 that is formed in the base connector 106. As shown in FIGs. 4, 5b, 5d, the extension 116 of the housing connector 104 is adapted to extend into an aperture 150 that is formed in the moveable mechanism 108.
  • the housing connector 104 is typically made of polymeric materials. Some examples of polymeric material that may be used in forming the housing connector is polycarbonate, nylon, and ABS plastic. It is contemplated that other materials may be used in forming the housing connector 104.
  • the base connector 106 includes the plurality of posts 130 and a plurality of generally rectangular-shaped legs 132.
  • the posts 130 are adapted to extend into the apertures 114a that are formed in the housing connector 104.
  • the number of posts 130 may vary from that depicted in FIGs. 8a-c. It is contemplated that the posts may be shaped different than depicted in FIGs. 8a-c.
  • the generally rectangular-shaped legs 132 of FIGs. 8a-c are adapted to snap over a respective one of the plurality of generally triangular-shaped plugs 118 (see FIGs. 7a, c, d).
  • the plugs 118 are designed to allow the housing connector 104 to move from a first position to a second position, while still being coupled to the base connector 106.
  • the base connector 106 is coupled to the housing connector 104 as shown in FIGs. 5a-d.
  • the posts 130 and the plurality of legs 132 of the base connector 106 work with receiving portions 114 and the plurality of plugs 118 of the housing connector 104 to couple the base connector 106 and the housing connector 104.
  • the housing connector 104 and the base connector 106 are coupled together such as shown in FIGs. 5a,b, they form a sensor- receiving opening 140a that is adapted to receive one of the plurality of test sensors.
  • the opening 140a has a floor 142 in which one of the plurality of test sensors may rest thereon.
  • the extension 116 of the housing connector 104 is adapted to extend into an aperture 152 that is formed in the moveable mechanism 108.
  • the extension 116 and the aperture 152 form a snap fit. It is contemplated that the housing connector and the moveable mechanism may be attached by other methods.
  • the housing connector 104 is adapted to move between a first position (FIGs. 5a,b) and a second position (FIGs. 5c,d).
  • a test sensor In the first position, a test sensor is held in place during the testing after being repositioned into the opening 140a from the cartridge.
  • the moveable mechanism is a pusher 141.
  • a user moves the pusher 141 inwards toward the sensor-dispensing instrument (in the direction of arrow A in FIG. 9). This movement moves a test sensor at least partially out of the cartridge and into the opening 140a.
  • the pusher 141 pivots the housing connector 104 down into the first position so that the semiconductor probes 102 contact the test sensor.
  • the sensor-receiving opening 140a is sized such that the height of the opening 140a is roughly the same as the thickness of the test sensor.
  • the height of the opening 140a may be about 15 mils and the thickness of the test sensor may be about 15 mils. It is contemplated that the height of opening 140a, as well as the test sensor, may be of different dimensions.
  • the housing connector 104 in one embodiment is moved to a second position by lifting the housing connector 104 with respect to the base connector 106 .
  • the opening begins getting larger ⁇ see opening 140b in FIGs. 5c,d) and the grip on the test sensor lessens.
  • a user presses the button 143, which is coupled to the pusher 141.
  • the movement of a button 143 moves the pusher 141 backwards and away from the sensor-dispensing device (in the direction of arrow B of FIG. 9).
  • the moveable mechanism used to remove the test sensor from the sensor-dispensing instrument is a lever 108.
  • This lever 108 is shown in FIG. 5c.
  • the lever 108 may be, for example, pressed or pulled by a user, which allows at least one of the base connector 106 and the housing connector 104 to move to a second position. By moving at least one of the base connector 106 and the housing connector 104 to a second position, a wider opening is formed between the base connector 106 and housing connector 104 that enables the test sensor to be removed from the sensor-dispensing instrument.
  • the opening 140b is sized such that the height of the opening 140b is greater than the thickness of the test sensor.
  • the height of the opening 140b maybe about 30 mils and the thickness of the test sensor may be about 15 mils. It is contemplated that the height of the opening 140b may be of a different dimension.
  • the user may remove the test sensor by, for example, tipping the sensor- dispensing instrument such that the test sensor exits via gravity. It is contemplated that the test sensor may be removed by other methods such as grasping and pulling the test sensor from the sensor-dispensing instrument. Alternatively, a button may be pressed that results in the test sensor being ejected from the sensor-dispensing instrument. It is also contemplated that the test sensor may be removed from the sensor-dispensing instrument by a pivoting lever or pulling mechanism.
  • the base connector instead of the housing connector may be adapted to move between a first position and a second position such as has been described above with respect to the housing connector.
  • the moveable mechanism may be adapted to move the base connector between the first and second positions.
  • a moveable mechanism may be used such as the moveable mechanism 108 shown in FIGs. 4b, 5.
  • the moveable mechanism 108 of FIGs. 4b, 5 is a lever or pivoting arm.
  • the moveable mechanism 108 moves the housing connector 104 between the first position (FIGs. 5a, b) and the second position ⁇ see FIGs. 5c, d).
  • the moveable mechanism may include a spring or other suitable component.
  • the moveable mechanism is shown in FIGs. 5a-d as being connected both to the housing connector 104 and the base connector 106. It is contemplated, however, that the moveable mechanism 108 may be connected to exactly one of the housing connector 104 and the base connector 106. For example, the moveable mechanism 108 may be connected only to the housing connector 104, but not the base connector 106. Similarly, the moveable mechanism 108 may be connected only to the base connector 106, but not the housing connector 104. In such embodiments, either the housing connector 104 or the base connector 106 would need to be moved with respect to either other so as to form a sensor-receiving opening 140a,b.
  • the moveable mechanism 108 is shown as moving the housing connector 104 with respect to the base connector 106. It is contemplated that the moveable mechanism 108 may be connected such that the base connector 106 may be moved with respect to the housing connector 104. In such an embodiment, the base connector 106 instead of the housing connector 104 would be moved between first and second positions. Alternatively, both the housing connector 104 and the base connector 106 may be moved with respect to each other. In such an embodiment, both the housing connector 104 and the base connector 106 would be moved between respective first positions and respective second positions.
  • a sensor-dispensing instrument is provided that is adapted to include a cartridge ⁇ e.g., cartridges 10, 50 of FIGs. 1 and 2a) that contains a plurality of electrochemical test sensors.
  • the sensor-dispensing instrument is activated by a user, which results in a test sensor being at least partially removed from the cartridge and repositioned to contact a portion of the multi-contact connector assembly.
  • the semiconductor probes touch respective conductive pads on the test sensor. After the semiconductor probes touch the respective conductive pads, electrical current is allowed to flow through the electrical leads to the electronic PC board.
  • the software in the sensor-dispensing instrument detects the electrical current and performs an auto-calibration program. After the auto-calibration program is completed, the test sensor is ready to accept a fluid for testing the concentration of at least one analyte (e.g., blood glucose). The fluid is placed on the test sensor and the software begins a countdown to displaying the analyte concentration in the fluid sample.
  • analyte e.g., blood glucose
  • a connector assembly adapted to be used in a sensor-dispensing instrument containing a plurality of electrochemical test sensors for determining an analyte concentration
  • the connector assembly comprising: at least two semiconductor probes; a housing connector forming at least one housing opening, the at least one housing opening being adapted to receive the at least two semiconductor probes; at least two electrical leads coupled to the housing connector, each of the at least two electrical leads being adapted to contact a respective one of the at least two semiconductor probes; a base connector being coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors, at least one of the base connector and the housing connector being adapted to move between a first position and a second position; and a moveable mechanism coupled to at least one of the housing connector and the base connector, the moveable mechanism being adapted to move at least one of the base connector or the housing connector between the first position and the second position, wherein the housing connector and the base connector are adapted to be coupled in a first position
  • each of the at least two semiconductor probes contains a spring adapted to maintain contact between the at least two semiconductor probes and one of plurality of test strips.
  • a sensor-dispensing instrument adapted to determine an analyte concentration
  • the sensor-dispensing instrument comprising: a plurality of electrochemical test sensors; a cartridge containing the plurality of electrochemical test sensors; a connector assembly including at least two semiconductor probes, a housing connector, at least two electrical leads, a base connector, and a moveable mechanism, the housing connector forming at least one opening being adapted to receive the at least two semiconductor probes, the at least two electrical leads being coupled to the housing connector and being adapted to contact a respective one of the at least two semiconductor probes, the base connector being coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors, the moveable mechanism being coupled to at least one of the housing connector and the base connector and adapted to move at least one of the housing connector and the base connector between a first position and a second position, wherein the housing connector and the base connector are adapted to be coupled in a first position so as to hold one of the plurality of
  • the sensor-dispensing instrument of embodiment N further ⁇ omprising at least one mounting pad adapted to hold the at least two electrical in place.
  • each of the at least two semiconductor probes contains a spring adapted to keep the semiconductor probe in contact with one of the plurality of test strips.
  • a method of using a sensor-dispensing instrument to determine an analyte concentration comprising the acts of: providing a sensor-dispensing instrument including a plurality of electrochemical test sensors, a cartridge containing the plurality of electrochemical test sensors, and a connector assembly, the connector assembly including at least two semiconductor probes, a housing connector, at least two electrical leads, a base connector, and a moveable mechanism, the housing connector forming at least one opening being adapted to receive the at least two semiconductor probes, the at least two electrical leads being coupled to the housing connector and being adapted to contact a respective one of the at least two semiconductor probes, the base connector being coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors, the moveable mechanism being coupled to at least one of the housing connector and the base connector; repositioning one of the plurality of test sensors from the cartridge to the sensor-receiving opening; placing at least one of the base connector and the housing connector in a first position
  • the method of process AA wherein the moving includes moving the housing connector between a first position and a second position, the moveable mechanism is adapted to move the housing connector between the first position and the second position.

Abstract

A multi-contact connector assembly is adapted to allow for a number of contacts between a test sensor-dispensing instrument and a test sensor. The instrument is adapted to determine the concentration of an analyte, such as glucose, in a fluid. The connector assembly comprises semiconductor probes, a housing connector, electrical leads, a base connector, and a moveable mechanism. Fluid, such as blood, is placed on the test sensor. Each of the semiconductor probes is adapted to pivot in order to make contact with a respective reagent pad on the test sensor and is coupled to a respective electrical lead. An electric current flows through the electrical leads to the PC board, and the software in the device displays a blood glucose result.

Description

MULTI-CONTACT CONNECTOR ASSEMBLY FOR A SENSOR-DISPENSING INSTRUMENT
FIELD OF THE INVENTION
[0001] The present invention generally relates to a multi-contact connector assembly for a sensor-dispensing instrument and, more particularly, to a multi-contact connector assembly that is adapted to be used to determine at least one analyte concentration in a fluid such as, for example, blood glucose.
BACKGROUND OF THE INVENTION
[0002] The quantitative determination of analytes in body fluids is of great importance in the diagnoses and maintenance of certain physiological abnormalities. For example, lactate, cholesterol and bilirubin should be monitored in certain individuals. In particular, determining glucose in body fluids is important to diabetic individuals who must frequently check the glucose level in their body fluids to regulate the glucose intake in their diets. While the remainder of the disclosure herein will be directed towards a multi-contact connector assembly to assist in determining glucose, it is to be understood that it may be used for determining other analytes on selection of an appropriate enzyme.
[0003] The results of such tests can be used to determine what, if any, insulin or other medication needs to be administered. In one type of blood glucose testing system, test sensors are used to test the sample of blood.
[0004] A test sensor contains biosensing or reagent material that will react with blood glucose. The testing end of the sensor is adapted to be placed into the fluid being tested, for example, blood that has accumulated on a person's finger after the finger has been pricked. The fluid is drawn into a capillary channel that extends in the sensor from the testing end to the reagent material by capillary action so that a sufficient amount of fluid to be tested is drawn into the sensor. The fluid then chemically reacts with the reagent material in the sensor resulting in an electrical signal indicative of the glucose level in the fluid being tested is supplied to contact areas located near the rear or contact end of the sensor.
[0005] It would be desirable to have a multi-contact connector assembly that would allow for a number of contacts between the sensor-dispensing instrument and the test sensor, while still being reliable and efficiently placed. SUMMARY OF THE INVENTION
[0006] According to one embodiment, a multi-contact connector assembly is adapted to be used in a sensor-dispensing instrument that contains a plurality of electrochemical test sensors. The multi-contact connector assembly comprises at least two semiconductor probes, a housing connector, at least two electrical leads, a base connector, and a moveable mechanism. The housing connector forms at least one housing opening. The at least one housing opening is adapted to receive the at least two semiconductor probes. The at least two electrical leads are coupled to the housing connector and adapted to contact a respective one of the at least two semiconductor probes. The at least two electrical leads may be coupled to at least one mounting pad to hold the at least two electrical leads in place and keep them separate. The base connector is coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors. At least one of the base connector and the housing connector is adapted to move between a first position and a second position. The moveable mechanism is coupled to at least one of the housing connector and the base connector. The moveable mechanism is adapted to move at least one of the base connector and the housing connector between the first position and the second position. The housing connector and the base connector are adapted to be coupled in a first position so as to hold one of the plurality of test sensors. The housing connector and the base connector are adapted to be coupled in a second position so as to allow the test sensor to be removed therefrom.
[0007] According to one embodiment, a sensor-dispensing instrument is adapted to •determine an analyte concentration. The sensor-dispensing instrument comprises a plurality of electrochemical test sensors, a cartridge containing the plurality of electrochemical test sensors, and a multi-contact connector assembly. The multi-contact connector assembly comprises at least two semiconductor probes, a housing connector, at least two electrical leads, a base connector, and a moveable mechanism. The housing connector forms at least one housing opening. The at least one housing opening is adapted to receive the at least two semiconductor probes. The at least two electrical leads are coupled to the housing connector and adapted to contact a respective one of the at least two semiconductor probes. The at least two electrical leads may be coupled to at least one mounting pad to hold the at least two electrical leads in place and keep them separate. The base connector is coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors. At least one of the base connector and the housing connector is adapted to move between a first position and a second position. The moveable mechanism is coupled to at least one of the housing connector and the base connector. The moveable mechanism is adapted to move at least one of the base connector or the housing connector between the first position and the second position. The housing connector and the base connector are adapted to be coupled in a first position so as to hold one of the plurality of test sensors, and the one of the plurality of test sensors is adapted to contact the at least two semiconductor probes to assist in determining the analyte concentration. The housing connector and the base connector are adapted to be coupled in a second position so as to allow the test sensor to be removed therefrom.
[0008] According to one method, a sensor-dispensing instrument is used to determine an analyte concentration. A sensor-dispensing instrument is provided that includes a plurality of electrochemical test sensors, a cartridge containing the plurality of electrochemical test sensors, and a multi-contact connector assembly. The multi-contact connector assembly comprises at least two semiconductor probes, a housing connector, at least two electrical leads, a base connector, and a moveable mechanism. The housing connector forms at least one housing opening. The at least one housing opening is adapted to receive the at least two semiconductor probes. The at least two electrical leads are coupled to the housing connector and adapted to contact a respective one of the at least two semiconductor probes. The at least two electrical leads may be coupled to at least one mounting pad to hold the at least two electrical leads in place and keep them separate. The base connector is adapted to be coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors. The moveable mechanism is adapted to be coupled to at least one of the housing connector and the base connector. At least one of the base connector and the housing connector is placed in a first position. One of the plurality of test sensors is repositioned from the cartridge to the sensor-receiving opening such that one of the plurality of test sensors contacts the at least two semiconductor probes to assist in determining the analyte concentration. At least one of the base connector and the housing connector is moved to a second position from the first position via the moveable mechanism. A fluid with at least one analyte is placed on the one of the plurality of test sensors. The concentration of the at least one analyte is determined.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 is a perspective view of a sensor-dispensing instrument in the open position showing a sensor pack being inserted according to one embodiment. [0010] FIG. 2a is a front view of a disposable cartridge with a plurality of stacked test sensors according to one embodiment.
[0011] FIG. 2b is a front view of a sensor-dispensing instrument according to one embodiment that is adapted to receive the cartridge of FIG. 2a.
[0012] FIG. 3a is a test sensor including a lid according to one embodiment.
[0013] FIG. 3b is the test sensor of FIG. 3a without the lid.
[0014] FIG. 4a is an inverted and exploded perspective view of a multi-contact connector assembly according to one embodiment of the present invention before being coupled to a base connector.
[0015] FIG. 4b is the perspective view of a multi-contact connector assembly of FIG. 4a.
[0016] FIG. 4c is an internal perspective view of a sensor-dispensing instrument according to one embodiment depicting the multi-contact connector assembly of FIG. 4b.
[0017] FIG. 5a, 5b are end views of the multi-contact connector assembly of FIG. 4b in a first position.
[0018] FIG. 5c, 5d are end views of the multi-contact contactor assembly of FIG. 4b in a second position.
[0019] FIG. 6 is an internal view of a semiconductor probe according to one embodiment used in a multi-contact connector assembly.
[0020] FIG. 7a is a bottom view of a housing connector of FIG. 4b.
[0021] FIG. 7b, 7c are perspective views of the housing connector with a plurality of semiconductor probes of FIG. 4.
[0022] FIG. 8a is a top view of the base connector of FIG. 4b.
[0023] FIG. 8b is a top perspective view of the base connector of FIG. 4b.
[0024] FIG. 8c is a bottom perspective view of the base connector of FIG. 4b.
[0025] FIG. 9 is a perspective view of the sensor-dispensing device of FIG. 4c further including a moveable mechanism being a pusher according to another embodiment.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0026] The present invention is directed to a multi-contact connector assembly to be used in a sensor-dispensing instrument that contains a plurality of electrochemical test sensors. The electrochemical test sensors are used to determine concentrations of at least one analyte in a fluid. Analytes that may be determined using the multi-contact connector assembly of the present invention include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin AjC, fructose, lactate, or bilirubin. The present invention is not limited, however, to determining these specific analytes and it is contemplated that other analyte concentrations may be determined. The analytes may be in, for example, a whole blood sample, a blood serum sample, a blood plasma sample, or other body fluids like ISF (interstitial fluid) and urine.
[0027] The plurality of test sensors is typically stored in a disposable cartridge. For example, the plurality of test sensors may be stored in a sensor pack where the test sensors are individually packaged in sensor cavities (e.g., a blister-type pack). An example of a disposable cartridge 10 being placed in a sensor-dispensing instrument 20 is depicted in FIG. 1. The disposable cartridge 10 is an example of a blister-type pack. The cartridge 10 includes a plurality of test sensors 12 that is individually stored in a respective one of sensor cavities 14. It is contemplated that other sensor packs that individually hold the sensors may be used. The disposable cartridge 10 of FIG. 1 is further described at U.S. Publication No. 2003/0032190 that published on February 13, 2003 and is entitled "Mechanical Mechanism for a Blood Glucose Sensor- Dispensing Instrument."
[0028] The plurality of test sensors may be stacked in a disposable cartridge such as shown in FIG. 2a. Referring to FIG. 2a, a disposable cartridge 50 includes a housing 52 and a plurality of stacked test sensors 54 that are moved in the direction of arrow A via a spring 56. The cartridge 50 also includes a plurality of seals 58a,b that protects the stacked test sensors 54 from humidity. The test sensors 54, one at a time, exit the cartridge 50, via opening 60. The disposable cartridge 50 may be stored in a sensor-dispensing instrument 70 of FIG. 2b. It is contemplated that other cartridges besides cartridges 10, 50 may be used.
[0029] The cartridges 10, 50 of FIGs. 1 and 2a may vary in the number of test sensors that are included so as to address the needs of different users. Typically, the cartridges contain from about 10 to about 50 sensors and, more specifically, contain from about 25 to about 40 sensors. Because of limited shelf-and use-life of the test sensors, it is envisioned that a user who tests infrequently would likely desire a cartridge having less test sensors as opposed to a user who tests more frequently.
[0030] The test sensors to be used in the cartridges are typically provided with a capillary channel that extends from the front or testing end of the sensors to biosensing or reagent material disposed in the sensor. When the testing end of the sensor is placed into fluid (e.g., blood that is accumulated on a person's finger after the finger has been pricked), a portion of the fluid is drawn into the capillary channel by capillary action. The fluid then chemically reacts with the reagent material in the sensor so that an electrical signal indicative of the analyte (e.g., glucose) level in the fluid being tested is supplied and subsequently transmitted to an electrical assembly. [0031] Reagent material that may be used to determine the glucose concentration include glucose oxidase. It is contemplated that other reagent material may be used to determine the glucose concentration such as glucose dehydrogenase. It is further contemplated that other reagent material may be used to assist in determining glucose such as, for example, pyrrolo- quinoline quinone glucose dehydrogenase and potassium ferricyanide. The selected reagent may influence items such as the amount of fluid needed and the length of time needed to perform the testing to determine the analyte concentration.
[0032] One non-limiting example of a test sensor is shown in FIGs. 3a, 3b. FIGs. 3a, 3b depict a test sensor 70 that includes a capillary channel 72, a lid 74, and a plurality of electrodes 76, 78, and 80. The plurality of electrodes includes a counter electrode 76, a detection electrode 78, and a working (measuring) electrode 80. As shown in FIG. 3b, the test sensor 70 includes a fluid-receiving area 82 that contains reagent. The operation of fluid-receiving area with reagent and the electrodes on the test sensors is known to those skilled in the art and will therefore not be described in further detail. Examples of electrochemical test sensors, including their operation, may be found at, for example, U.S. Patent Application published as 2001/0042683 and EP 1152239. It is contemplated that other electrochemical test sensors may be employed. [0033] According to one embodiment, the plurality of test sensors is adapted to auto- calibrate themselves. Having test sensors that auto-calibrate is advantageous because it minimizes the parts needed in the sensor-dispensing instrument. Additionally, having auto- calibration may be desirable because it eliminates the need for a user to enter information about the product lot number of the test sensors so as to perform the correct program associated with the product lot number. It is contemplated, however, that the plurality of test sensors may not have the ability to auto-calibrate themselves.
[0034] Referring to FIGs. 4 and 5, a multi-contact connector assembly 100 is shown according to one embodiment. The multi-contact connector assembly 100 is adapted to make a connection between the test sensor with reagent and the electronic system of the sensor- dispensing instrument. The software located in the sensor-dispensing instrument uses the electrical signals to output at least one analyte concentration of the fluid (e.g., a blood glucose level). The multi-contact connector assembly 100 comprises at least two semiconductor probes 102, a housing connector 104, at least two electrical leads 103, a base connector 106, and a moveable mechanism 108.
[0035] The multi-contact connector assembly 100 of FIGs. 4 and 5 includes exactly three semiconductor probes 102a-c and three corresponding electrical leads 103a-c. It is contemplated that the multi-contact connector assembly may have exactly two semiconductor probes or may have four or more semiconductor probes. As shown in FIGs. 4b and 5, each of the semiconductor probes 102a-c is fixed in the housing connector 104 and positioned to make contact with a test sensor.
[0036] Referring to FIG. 6, the semiconductor probe 102 may be desirably formed to contain a spring 105 so as to maintain an improved connection between the semiconductor probes' 102a-c and the test sensors. In this embodiment, the barrel 107 of the semiconductor probe 102 encases a spring 105. A moveable plunger 109 is located on the end of the semiconductor probe 102 that contacts the test sensor (e.g., test sensor 12). When the multi-contact connector assembly 100 is in the first position such that the test sensor 12 makes contact with the semiconductor probes 102, the plunger 109 moves up into the barrel 107 in the direction of arrow 113 in FIG. 6, thereby compressing the spring 105. The compressed spring 105 correspondingly exerts a downward pressure on the plunger 109 so that the semiconductor probe 102 remains generally coplanar with the test sensor 12, thereby enhancing the likelihood that the semiconductor probe 102 remains in contact with the test sensor 12.
[0037] The components of the semiconductor probes 102a-c may be made of different materials, but are typically made of metal. One example of a material that may be used in forming the barrel 107 of the semiconductor probes 102 is gold-plated nickel silver. It is contemplated that materials such as passivated stainless steel may be used in forming the spring 105. The plunger 109 may be made of gold-plated, full-hard beryllium copper. Additionally, the plurality of semiconductor probes may be shaped differently than depicted in FIGs. 4 and 6. [0038] Referring back to FIGs. 4 and 5, in one embodiment, the electrical leads 103 are adapted to communicate with an electronic PC board. In such an embodiment, the electrical leads 103 may extend through apertures formed in the electronic PC board. To prevent or inhibit, losing electrical contact between the electronic PC board and the electrical leads, the electrical leads may be held in place by mounting pads 111, such as shown in FIGs. 4a,b. Additionally, the mounting pads 111 assist in keeping the electrical leads 103 separated from each other. [0039] As shown in FIGs. 4a,b and 7, the housing connector 104 forms a plurality of housing openings or apertures 110a-c that are sized to accept a respective semiconductor probe 102a-c. The semiconductor probes 102a-c are shown in the housing openings 110a-c in FIG. 4b. It is contemplated that the housing connector may have less openings than depicted in FIGs. 4a,b. For example, the housing connector 104 may have at least one opening that receives the semiconductor probes 102a-c. Such embodiments with fewer openings are often less desirable because of the need to electrically isolate the semiconductor probes 102a-c from each other. It is also contemplated that the housing openings 110 may be shaped differently than depicted in FIGs. 4 and 7.
[0040] The housing connector 104 also includes a plurality of bosses 112. The bosses 112 are adapted to snap into corresponding apertures formed in the electronic PC board of the sensor- dispensing instrument. It is contemplated that the multi-contact connector assembly may be installed in a different manner to the electronic PC board.
[0041] The housing connector 104 further includes a plurality of base-connecting receiving portions 114, an extension 116, and a plurality of generally triangular-shaped plugs 118. Each of the receiving portions 114 forms an aperture 114a. As shown in FIGs. 4 and 7, the apertures 114a are sized to receive a respective one of a plurality of posts 130 that is formed in the base connector 106. As shown in FIGs. 4, 5b, 5d, the extension 116 of the housing connector 104 is adapted to extend into an aperture 150 that is formed in the moveable mechanism 108. The housing connector 104 is typically made of polymeric materials. Some examples of polymeric material that may be used in forming the housing connector is polycarbonate, nylon, and ABS plastic. It is contemplated that other materials may be used in forming the housing connector 104.
[0042] Referring to FIGs. 8a-c, the base connector 106 includes the plurality of posts 130 and a plurality of generally rectangular-shaped legs 132. The posts 130 are adapted to extend into the apertures 114a that are formed in the housing connector 104. The number of posts 130 may vary from that depicted in FIGs. 8a-c. It is contemplated that the posts may be shaped different than depicted in FIGs. 8a-c.
[0043] The generally rectangular-shaped legs 132 of FIGs. 8a-c are adapted to snap over a respective one of the plurality of generally triangular-shaped plugs 118 (see FIGs. 7a, c, d). The plugs 118 are designed to allow the housing connector 104 to move from a first position to a second position, while still being coupled to the base connector 106. The base connector 106 is coupled to the housing connector 104 as shown in FIGs. 5a-d.
[0044] The posts 130 and the plurality of legs 132 of the base connector 106 work with receiving portions 114 and the plurality of plugs 118 of the housing connector 104 to couple the base connector 106 and the housing connector 104. When the housing connector 104 and the base connector 106 are coupled together such as shown in FIGs. 5a,b, they form a sensor- receiving opening 140a that is adapted to receive one of the plurality of test sensors. The opening 140a has a floor 142 in which one of the plurality of test sensors may rest thereon. [0045] As shown in FIG. 5b, the extension 116 of the housing connector 104 is adapted to extend into an aperture 152 that is formed in the moveable mechanism 108. The extension 116 and the aperture 152 form a snap fit. It is contemplated that the housing connector and the moveable mechanism may be attached by other methods.
[0046] The housing connector 104 is adapted to move between a first position (FIGs. 5a,b) and a second position (FIGs. 5c,d). In the first position, a test sensor is held in place during the testing after being repositioned into the opening 140a from the cartridge. Referring to the embodiment of FIG. 9, the moveable mechanism is a pusher 141. A user moves the pusher 141 inwards toward the sensor-dispensing instrument (in the direction of arrow A in FIG. 9). This movement moves a test sensor at least partially out of the cartridge and into the opening 140a. Once the test sensor is positioned in the opening 140a, the pusher 141 pivots the housing connector 104 down into the first position so that the semiconductor probes 102 contact the test sensor.
[0047] Referring to FIG. 6, when the multi-contact connector assembly is in the first position, the spring 105 inside each of the plurality of semiconductor probes 102 is compressed to increase the likelihood that the plurality of semiconductor probes 102 remain in contact with the test sensor 12. In one embodiment, the sensor-receiving opening 140a is sized such that the height of the opening 140a is roughly the same as the thickness of the test sensor. For example, the height of the opening 140a may be about 15 mils and the thickness of the test sensor may be about 15 mils. It is contemplated that the height of opening 140a, as well as the test sensor, may be of different dimensions.
[0048] After the testing has been completed, the used test sensor is removed. To remove the test sensor, the housing connector 104 in one embodiment is moved to a second position by lifting the housing connector 104 with respect to the base connector 106 . When the housing connector 104 is moved to a second position, the opening begins getting larger {see opening 140b in FIGs. 5c,d) and the grip on the test sensor lessens. In the embodiment of FIG. 9, a user presses the button 143, which is coupled to the pusher 141. The movement of a button 143 moves the pusher 141 backwards and away from the sensor-dispensing device (in the direction of arrow B of FIG. 9). The movement of the pusher 141 pivots the housing connector 104 so that the semiconductor probes 102 lift off of the test sensor and the multi-contact connector returns to a second position, thereby allowing the test sensor to be removed therefrom. [0049] In another embodiment, the moveable mechanism used to remove the test sensor from the sensor-dispensing instrument is a lever 108. This lever 108 is shown in FIG. 5c. The lever 108 may be, for example, pressed or pulled by a user, which allows at least one of the base connector 106 and the housing connector 104 to move to a second position. By moving at least one of the base connector 106 and the housing connector 104 to a second position, a wider opening is formed between the base connector 106 and housing connector 104 that enables the test sensor to be removed from the sensor-dispensing instrument.
[0050] To assist in removing the test sensor, the opening 140b is sized such that the height of the opening 140b is greater than the thickness of the test sensor. For example, the height of the opening 140b maybe about 30 mils and the thickness of the test sensor may be about 15 mils. It is contemplated that the height of the opening 140b may be of a different dimension. By having a larger opening, the user may remove the test sensor by, for example, tipping the sensor- dispensing instrument such that the test sensor exits via gravity. It is contemplated that the test sensor may be removed by other methods such as grasping and pulling the test sensor from the sensor-dispensing instrument. Alternatively, a button may be pressed that results in the test sensor being ejected from the sensor-dispensing instrument. It is also contemplated that the test sensor may be removed from the sensor-dispensing instrument by a pivoting lever or pulling mechanism.
[0051] According to another embodiment, the base connector instead of the housing connector may be adapted to move between a first position and a second position such as has been described above with respect to the housing connector. In such an embodiment, the moveable mechanism may be adapted to move the base connector between the first and second positions.
[0052] To move the housing connector 104 with respect to the base connector 106 according to another embodiment, a moveable mechanism may be used such as the moveable mechanism 108 shown in FIGs. 4b, 5. The moveable mechanism 108 of FIGs. 4b, 5 is a lever or pivoting arm. The moveable mechanism 108 moves the housing connector 104 between the first position (FIGs. 5a, b) and the second position {see FIGs. 5c, d). To assist in maintaining the moveable mechanism in the first position, the moveable mechanism may include a spring or other suitable component.
[0053] The moveable mechanism is shown in FIGs. 5a-d as being connected both to the housing connector 104 and the base connector 106. It is contemplated, however, that the moveable mechanism 108 may be connected to exactly one of the housing connector 104 and the base connector 106. For example, the moveable mechanism 108 may be connected only to the housing connector 104, but not the base connector 106. Similarly, the moveable mechanism 108 may be connected only to the base connector 106, but not the housing connector 104. In such embodiments, either the housing connector 104 or the base connector 106 would need to be moved with respect to either other so as to form a sensor-receiving opening 140a,b. [0054] The moveable mechanism 108 is shown as moving the housing connector 104 with respect to the base connector 106. It is contemplated that the moveable mechanism 108 may be connected such that the base connector 106 may be moved with respect to the housing connector 104. In such an embodiment, the base connector 106 instead of the housing connector 104 would be moved between first and second positions. Alternatively, both the housing connector 104 and the base connector 106 may be moved with respect to each other. In such an embodiment, both the housing connector 104 and the base connector 106 would be moved between respective first positions and respective second positions.
[0055] According to one method, a sensor-dispensing instrument is provided that is adapted to include a cartridge {e.g., cartridges 10, 50 of FIGs. 1 and 2a) that contains a plurality of electrochemical test sensors. The sensor-dispensing instrument is activated by a user, which results in a test sensor being at least partially removed from the cartridge and repositioned to contact a portion of the multi-contact connector assembly. The semiconductor probes touch respective conductive pads on the test sensor. After the semiconductor probes touch the respective conductive pads, electrical current is allowed to flow through the electrical leads to the electronic PC board.
[0056] According to one method, the software in the sensor-dispensing instrument detects the electrical current and performs an auto-calibration program. After the auto-calibration program is completed, the test sensor is ready to accept a fluid for testing the concentration of at least one analyte (e.g., blood glucose). The fluid is placed on the test sensor and the software begins a countdown to displaying the analyte concentration in the fluid sample. [0057] Alternative Embodiment A
A connector assembly adapted to be used in a sensor-dispensing instrument containing a plurality of electrochemical test sensors for determining an analyte concentration, the connector assembly comprising: at least two semiconductor probes; a housing connector forming at least one housing opening, the at least one housing opening being adapted to receive the at least two semiconductor probes; at least two electrical leads coupled to the housing connector, each of the at least two electrical leads being adapted to contact a respective one of the at least two semiconductor probes; a base connector being coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors, at least one of the base connector and the housing connector being adapted to move between a first position and a second position; and a moveable mechanism coupled to at least one of the housing connector and the base connector, the moveable mechanism being adapted to move at least one of the base connector or the housing connector between the first position and the second position, wherein the housing connector and the base connector are adapted to be coupled in a first position so as to hold one of the plurality of test sensors and the housing connector and the base connector are adapted to be coupled in a second position so as to allow the test sensors to be removed therefrom. [0058] Alternative Embodiment B
The assembly of embodiment A wherein the housing connector forms at least two openings, each of the at least two openings being adapted to receive a respective one of the at least two semiconductor probes. [0059] Alternative Embodiment C
The assembly of embodiment A further comprising at least one mounting pad adapted to hold the at least two electrical leads in place. [0060] Alternative Embodiment D
The assembly of embodiment A former comprising a button adapted to be coupled to the moveable mechanism. [0061] Alternative Embodiment E
The assembly of embodiment A wherein each of the at least two semiconductor probes contains a spring adapted to maintain contact between the at least two semiconductor probes and one of plurality of test strips. [0062] Alternative Embodiment F
The assembly of embodiment A wherein the housing connector comprises a plurality of bosses and a plurality of base-connecting receiving portions. [0063] Alternative Embodiment G
The assembly of embodiment F wherein the housing connector further includes an extension and a plurality of plugs, each of the plurality of base-connecting receiving portions forms an aperture. [0064] Alternative Embodiment H
The assembly of embodiment A wherein the moveable mechanism is coupled to the housing connector and the base connector. [0065] Alternative Embodiment I
The assembly of embodiment A wherein the moveable mechanism is a lever. [0066] Alternative Embodiment J
The assembly of embodiment A wherein the moveable mechanism is a pusher, the pusher being adapted to be activated by a user. [0067] Alternative Embodiment K
The assembly of embodiment A wherein the housing connector is adapted to move between a first position and a second position, the moveable mechanism is adapted to move the housing connector between the first position and the second position. [0068] Alternative Embodiment L
The assembly of embodiment A wherein the base connector includes a plurality of posts, a plurality of legs, and a prong. [0069] Alternative Embodiment M
The assembly of embodiment A wherein the housing connector includes a plurality of plugs, the base connector includes a plurality of legs, each of the plurality of legs being adapted to snap over a respective one of the plurality of plugs. [0070] Alternative Embodiment N
A sensor-dispensing instrument adapted to determine an analyte concentration, the sensor-dispensing instrument comprising: a plurality of electrochemical test sensors; a cartridge containing the plurality of electrochemical test sensors; a connector assembly including at least two semiconductor probes, a housing connector, at least two electrical leads, a base connector, and a moveable mechanism, the housing connector forming at least one opening being adapted to receive the at least two semiconductor probes, the at least two electrical leads being coupled to the housing connector and being adapted to contact a respective one of the at least two semiconductor probes, the base connector being coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors, the moveable mechanism being coupled to at least one of the housing connector and the base connector and adapted to move at least one of the housing connector and the base connector between a first position and a second position, wherein the housing connector and the base connector are adapted to be coupled in a first position so as to hold one of the plurality of test sensors and one of the plurality of test sensors is adapted to contact the at least two electrical leads to assist in determining the analyte concentration, and the housing connector and the base connector are adapted to be coupled in a second position so as to allow the test sensor to be removed therefrom. [0071] Alternative Embodiment O
The sensor-dispensing instrument of embodiment N wherein the housing connector forms at least two openings, each of the at least two openings being adapted to receive a respective one of the at least two semiconductor probes. [0072] Alternative Embodiment P
The sensor-dispensing instrument of embodiment N further Θomprising at least one mounting pad adapted to hold the at least two electrical in place. [0073] Alternative Embodiment O
The sensor-dispensing instrument of embodiment N further comprising a button adapted to be coupled to the moveable mechanism. [0074] Alternative Embodiment R
The sensor-dispensing instrument of embodiment N wherein each of the at least two semiconductor probes contains a spring adapted to keep the semiconductor probe in contact with one of the plurality of test strips. [0075] Alternative Embodiment S
The sensor-dispensing instrument of embodiment N wherein the housing connector comprises a plurality of bosses and a plurality of base-connecting receiving portions. [0076] Alternative Embodiment T
The sensor-dispensing instrument of embodiment S wherein the housing connector further includes an extension and a plurality of plugs, each of the plurality of base-connecting receiving portions forming an aperture. [0077] Alternative Embodiment U
The sensor-dispensing instrument of embodiment N wherein the moveable mechanism is coupled to the housing connector and the base connector. [0078] Alternative Embodiment V
The sensor-dispensing instrument of embodiment N wherein the moveable mechanism is a lever. [0079] Alternative Embodiment W
The sensor-dispensing instrument of embodiment N wherein the moveable mechanism is a pusher, the pusher being adapted to be activated by a user. [0080] Alternative Embodiment X
The sensor-dispensing instrument of embodiment N wherein the housing connector is adapted to move between a first position and a second position, the moveable mechanism being adapted to move the housing connector between the first position and the second position, and wherein the housing connector in the first position is adapted to hold one of the plurality of test sensors and the housing connector in the second position is adapted to allow the test sensor to be removed therefrom. [0081] Alternative Embodiment Y
The sensor-dispensing instrument of embodiment N wherein the base connector includes a plurality of posts, a plurality of legs, and a prong. [0082] Alternative Embodiment Z
The sensor-dispensing instrument of embodiment N wherein the housing connector includes a plurality of plugs, the base connector includes a plurality of legs, each of the plurality of legs being adapted to snap over a respective one of the plurality of plugs. [0083] Alternative Process AA
A method of using a sensor-dispensing instrument to determine an analyte concentration, the method comprising the acts of: providing a sensor-dispensing instrument including a plurality of electrochemical test sensors, a cartridge containing the plurality of electrochemical test sensors, and a connector assembly, the connector assembly including at least two semiconductor probes, a housing connector, at least two electrical leads, a base connector, and a moveable mechanism, the housing connector forming at least one opening being adapted to receive the at least two semiconductor probes, the at least two electrical leads being coupled to the housing connector and being adapted to contact a respective one of the at least two semiconductor probes, the base connector being coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors, the moveable mechanism being coupled to at least one of the housing connector and the base connector; repositioning one of the plurality of test sensors from the cartridge to the sensor-receiving opening; placing at least one of the base connector and the housing connector in a first position such that the one of the plurality of test sensors contacts the at least two electrical leads to assist in determining the analyte concentration; moving at least one of the base connector and the housing connector to a second position from the first position via the moveable mechanism; placing a fluid with at least one analyte on the one of the plurality of test sensors; and determining the concentration of the at least one analyte. [0084] Alternative Process BB
The method of process AA further including removing the one of the plurality of test sensors from the connector assembly when at least one of the base connector and the housing connector is in the second position. [0085] Alternative Process CC
The method of process AA further including removing the one of the plurality of test sensors from the connector assembly by pushing a button to return one of the base connector and housing connector to the second position. [0086] Alternative Process DD
The method of process AA wherein the analyte is glucose. [0087] Alternative Process EE
The method of process AA wherein the fluid is blood. [0088] Alternative Process FF
The method of process AA wherein the housing connector forms at least two openings, each of the at least two openings being adapted to receive a respective one of the at least two semiconductor probes. [0089] Alternative Process GG
The method of process AA wherein the moveable mechanism is coupled to the housing connector and the base connector. [0090] Alternative Process HH
The method of process AA wherein the moving includes moving the housing connector between a first position and a second position, the moveable mechanism is adapted to move the housing connector between the first position and the second position.
[0091] While the invention is susceptible to various modifications and alternative forms, specific embodiments are shown by way of example in the drawings and are described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

Claims

CLAIMS:
1. A connector assembly adapted to be used in a sensor-dispensing instrument containing a plurality of electrochemical test sensors for determining an analyte concentration, the connector assembly comprising: at least two semiconductor probes; a housing connector forming at least one housing opening, the at least one housing opening being adapted to receive the at least two semiconductor probes; at least two electrical leads coupled to the housing connector, each of the at least two electrical leads being adapted to contact a respective one of the at least two semiconductor probes; a base connector being coupled to the housing connector so as to form a sensor- receiving opening adapted to receive one of the plurality of test sensors, at least one of the base connector and the housing connector being adapted to move between a first position and a second position; and a moveable mechanism coupled to at least one of the housing connector and the base connector, the moveable mechanism being adapted to move at least one of the base connector or the housing connector between the first position and the second position, wherein the housing connector and the base connector are adapted to be coupled in a first position so as to hold one of the plurality of test sensors and the housing connector and the base connector are adapted to be coupled in a second position so as to allow the test sensors to be removed therefrom.
2. The assembly of claim 1, wherein the housing connector forms at least two openings, each of the at least two openings being adapted to receive a respective one of the at least two semiconductor probes.
3. The assembly of claim 1, further comprising at least one mounting pad adapted to hold the at least two electrical leads in place.
4. The assembly of claim 1, further comprising a button adapted to be coupled to the moveable mechanism.
5. The assembly of claim 1, wherein each of the at least two semiconductor probes contains a spring adapted to maintain contact between the at least two semiconductor probes and one of plurality of test strips.
6. The assembly of claim 1, wherein the housing connector comprises a plurality of bosses and a plurality of base-connecting receiving portions.
7. The assembly of claim 6, wherein the housing connector further includes an extension and a plurality of plugs, each of the plurality of base-connecting receiving portions forms an aperture.
8. The assembly of claim 1, wherein the moveable mechanism is coupled to the housing connector and the base connector.
9. The assembly of claim 1 , wherein the moveable mechanism is a lever.
10. The assembly of claim 1, wherein the moveable mechanism is a pusher, the pusher being adapted to be activated by a user.
11. The assembly of claim 1, wherein the housing connector is adapted to move between a first position and a second position, the moveable mechanism being adapted to move the housing connector between the first position and the second position.
12. The assembly of claim 1, wherein the base connector includes a plurality of posts, a plurality of legs, and a prong.
13. The assembly of claim 1, wherein the housing connector includes a plurality of plugs, the base connector includes a plurality of legs, each of the plurality of legs being adapted to snap over a respective one of the plurality of plugs.
14. A sensor-dispensing instrument adapted to determine an analyte concentration, the sensor-dispensing instrument comprising: a plurality of electrochemical test sensors; a cartridge containing the plurality of electrochemical test sensors; a connector assembly including at least two semiconductor probes, a housing connector, at least two electrical leads, a base connector, and a moveable mechanism, the housing connector forming at least one opening being adapted to receive the at least two semiconductor probes, the at least two electrical leads being coupled to the housing connector and being adapted to contact a respective one of the at least two semiconductor probes, the base connector being coupled to the housing connector so as to form a sensor- receiving opening adapted to receive one of the plurality of test sensors, the moveable mechanism being coupled to at least one of the housing connector and the base connector and adapted to move at least one of the housing connector and the base connector between a first position and a second position, wherein the housing connector and the base connector are adapted to be coupled in a first position so as to hold one of the plurality of test sensors and one of the plurality of test sensors is adapted to contact the at least two electrical leads to assist in determining the analyte concentration, and the housing connector and the base connector are adapted to be coupled in a second position so as to allow the test sensor to be removed therefrom.
15. The sensor-dispensing instrument of claim 14, wherein the housing connector forms at least two openings, each of the at least two openings being adapted to receive a respective one of the at least two semiconductor probes.
16. The sensor-dispensing instrument of claim 14, further comprising at least one mounting pad adapted to hold the at least two electrical in place.
17. The sensor-dispensing instrument of claim 14 further comprising a button adapted to be coupled to the moveable mechanism.
18. The sensor-dispensing instrument of claim 14, wherein each of the at least two semiconductor probes contains a spring adapted to keep the semiconductor probe in contact with one of the plurality of test strips.
19. The sensor-dispensing instrument of claim 14, wherein the housing connector comprises a plurality of bosses and a plurality of base-connecting receiving portions.
20. The sensor-dispensing instrument of claim 19, wherein the housing connector further includes an extension and a plurality of plugs, each of the plurality of base-connecting receiving portions forming an aperture.
21. The sensor-dispensing instrument of claim 14, wherein the moveable mechanism is coupled to the housing connector and the base connector.
22. The sensor-dispensing instrument of claim 14, wherein the moveable mechanism is a lever.
23. The sensor-dispensing instrument of claim 14, wherein the moveable mechanism is a pusher, the pusher being adapted to be activated by a user.
24. The sensor-dispensing instrument of claim 14, wherein the housing connector is adapted to move between a first position and a second position, the moveable mechanism being adapted to move the housing connector between the first position and the second position, and wherein the housing connector in the first position is adapted to hold one of the plurality of test sensors and the housing connector in the second position is adapted to allow the test sensor to be removed therefrom.
25. The sensor-dispensing instrument of claim 14, wherein the base connector includes a plurality of posts, a plurality of legs, and a prong.
26. The sensor-dispensing instrument of claim 14, wherein the housing connector includes a plurality of plugs, the base connector includes a plurality of legs, each of the plurality of legs being adapted to snap over a respective one of the plurality of plugs.
27. A method of using a sensor-dispensing instrument to determine an analyte concentration, the method comprising the acts of: providing a sensor-dispensing instrument including a plurality of electrochemical test sensors, a cartridge containing the plurality of electrochemical test sensors, and a connector assembly, the connector assembly including at least two semiconductor probes, a housing connector, at least two electrical leads, a base connector, and a moveable mechanism, the housing connector forming at least one opening being adapted to receive the at least two semiconductor probes, the at least two electrical leads being coupled to the housing connector and being adapted to contact a respective one of the at least two semiconductor probes, the base connector being coupled to the housing connector so as to form a sensor-receiving opening adapted to receive one of the plurality of test sensors, the moveable mechanism being coupled to at least one of the housing connector and the base connector; repositioning one of the plurality of test sensors from the cartridge to the sensor- receiving opening; placing at least one of the base connector and the housing connector in a first position such that the one of the plurality of test sensors contacts the at least two electrical leads to assist in determining the analyte concentration; moving at least one of the base connector and the housing connector to a second position from the first position via the moveable mechanism; placing a fluid with at least one analyte on the one of the plurality of test sensors; and determining the concentration of the at least one analyte.
28. The method of claim 27, further including removing the one of the plurality of test sensors from the connector assembly when at least one of the base connector and the housing connector is in the second position.
29. The method of claim 27, further including removing the one of the plurality of test sensors from the connector assembly by pushing a button to return one of the base connector and housing connector to the second position.
30. The method of claim 27, wherein the analyte is glucose.
31. The method of claim 27, wherein the fluid is blood.
32. The method of claim 27, wherein the housing connector forms at least two openings, each of the at least two openings being adapted to receive a respective one of the at least two semiconductor probes.
33. The method of claim 27, wherein the moveable mechanism is coupled to the housing connector and the base connector.
34. The method of claim 27, wherein the moving includes moving the housing connector between a first position and a second position, the moveable mechanism being adapted to move the housing connector between the first position and the second position.
PCT/US2005/045236 2004-12-13 2005-12-12 Multi-contact connector assembly for a sensor-dispensing instrument WO2006065901A1 (en)

Applications Claiming Priority (2)

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US63557504P 2004-12-13 2004-12-13
US60/635,575 2004-12-13

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020084196A1 (en) * 1999-11-04 2002-07-04 Therasense, Inc. Small volume in vitro analyte sensor and methods
US20030031599A1 (en) * 2001-08-13 2003-02-13 Brown Michael K. Blood glucose sensor dispensing instrument having a pull/push activation mechanism
EP1480036A1 (en) * 2002-02-28 2004-11-24 ARKRAY, Inc. Measurement instrument, measurement tool storage case and operation mechanism
WO2006023810A1 (en) * 2004-08-20 2006-03-02 Bayer Healthcare Llc Contact connector assembly for a sensor-dispensing instrument

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020084196A1 (en) * 1999-11-04 2002-07-04 Therasense, Inc. Small volume in vitro analyte sensor and methods
US20030031599A1 (en) * 2001-08-13 2003-02-13 Brown Michael K. Blood glucose sensor dispensing instrument having a pull/push activation mechanism
EP1480036A1 (en) * 2002-02-28 2004-11-24 ARKRAY, Inc. Measurement instrument, measurement tool storage case and operation mechanism
WO2006023810A1 (en) * 2004-08-20 2006-03-02 Bayer Healthcare Llc Contact connector assembly for a sensor-dispensing instrument

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