Fiber Optic Device for Sensing Analytes and Method of Making Same

Abstract

A device for sensing analyte concentration, and in particular glucose concentration, in vivo or in vitro is disclosed. A sensing element is attached to the distal end of an optical conduit, and comprises at least one binding protein adapted to bind with at least one target analyte. The sensing element further comprises at least one reporter group that undergoes a luminescence change with changing analyte concentrations. Optionally, the optical conduit and sensing element may be housed within a cannulated bevel.

1 - 71 . (canceled) 
     
     
         72 . A biosensor tip device for sensing glucose in a sample comprising:
 at least one needle having a proximal end and a distal end, an optical fiber with an external diameter of between 50 to 200 microns having a proximal end and a distal end, and a sensing element in optical proximity to the distal end of the tip body; the sensing element comprising at least one glucose galactose binding protein (GGBP), said GGBP being adapted to bind with at least glucose, and at least one reporter group associated with the GGBP, wherein the reporter group is adapted to undergo a luminescence change upon binding of the binding protein to the glucose, and wherein the sensing element is entrapped in or attached to a polymer matrix.   
     
     
         73 . The device of  claim 72 , further comprising an optical coupling member configured and dimensioned to receive an attachable optical component thereto. 
     
     
         74 . The device of  claim 72 , further comprising at least one reference group associated with the GGBP. 
     
     
         75 . The device of  claim 72 , wherein said sensing element is further adapted to be inserted into or through the skin of a patient. 
     
     
         76 . The device of  claim 72 , further comprising a temperature sensing element for sensing the temperature of the sample. 
     
     
         77 . The device of  claim 72 , wherein the device comprises a plurality of needles. 
     
     
         78 . The device of  claim 72 , wherein the device comprises two needles. 
     
     
         79 . The device of  claim 78 , wherein the first of the two needles comprises the sensing element, and the second of the two needles comprises a delivery means for delivering the therapeutic agent to the patient. 
     
     
         80 . The device of  claim 72 , further comprising a mount. 
     
     
         81 . The device of  claim 72 , wherein the sensing element is attached to the inner surface of the needle. 
     
     
         82 . The device of  claim 81 , wherein the sensing element comprises a polymeric matrix and the sensing element is attached to the inner surface of the needle via the polymeric matrix. 
     
     
         83 . The device of  claim 82 , wherein the polymeric matrix is further attached to the distal end of said optical fiber through reactive groups that are present on the polymeric matrix. 
     
     
         84 . The device of  claim 83 , wherein the polymeric matrix is attached to the distal end of the optic fiber through amine groups that are on the surface of the optical fiber. 
     
     
         85 . The device of  claim 84 , wherein the first of the two needles comprises the sensing element, and the second of the two tip bodies comprises a delivery means for delivering the therapeutic agent to the patient. 
     
     
         86 . The device of  claim 85 , further comprising a mount. 
     
     
         87 . The device of  claim 72 , where the optic fiber has an external diameter of 100 microns. 
     
     
         88 . A method of detecting levels of glucose in a sample comprising
 a. acquiring access to said sample;   b. inserting the device of  claim 72  into said sample;   c. allowing said sensing element to interact with said sample; and   d. determining the extent of luminescence change of said reporter group,   wherein the extent of luminescence change is indicative of the levels of said glucose in said sample.   
     
     
         89 . The method of  claim 88  wherein the sample is selected from the group consisting of blood, plasma, serum and interstitial fluid. 
     
     
         90 . The method of  claim 89 , wherein the sample is blood. 
     
     
         91 . The method of  claim 90 , further comprising accessing said sample through the skin of said subject. 
     
     
         92 . The method of  claim 91 , wherein said sample is accessed subcutaneously or intradermally.