Sensing apparatus and process

Abstract

A sensing apparatus with a connector, a sensor lead and a sensor module with a spacer placed over electrodes that have been deposited on a substrate. The spacer may have a space for receiving an enzyme. End portions of the sensor module may be encapsulated, such as with molded beads. A sensor lead may attach to the sensor module and may have an outer tubing that passes over the module and attaches to the beads at the end of the sensor module. The sensor lead may also attach to the connector such that the sensing apparatus may be electrically coupled to a pump, electronics or other devices. The sensing apparatus may be implanted into a vein or artery.

1 .- 23 . (canceled) 
     
     
         24 . A sensing apparatus comprising a sensor module comprising:
 a substrate having a first surface on which an electrode is provided;   a spacing element arranged adjacent the electrode, the spacing element having a catalyst receiving area for receiving an enzyme and maintaining the catalyst a defined distance from the electrode.   
     
     
         25 . A sensing apparatus of  claim 24 , where the sensor module further comprises a pair of beads coupled to the substrate and spaced apart to define a recess between the beads, the spacing element being arranged in the recess between the beads. 
     
     
         26 . A sensing apparatus of  claim 24 , further comprising:
 an electrical connection pad on the substrate;   a cable having an electrical conductor connected to the electrical connection pad;   where one of the beads encapsulates the electrical connection pad.   
     
     
         27 . A sensing apparatus of  claim 26 , where said one of the beads also encapsulates a portion of the cable. 
     
     
         28 . A sensing apparatus of  claim 26 , where:
 the cable has a connector and a length dimension; and   the electrical connection pad of the sensor module is connected to the cable at a location that is spaced apart from the connector such that the length dimension of the cable extends between the connector and the sensor module.   
     
     
         29 . A sensing apparatus of  claim 24 , where the substrate has a first end and a second end and the sensor module further comprises:
 a first electrical connection pad on the substrate, adjacent the first end of the substrate;   a second electrical connection pad on the substrate, adjacent the second end of the substrate;   a cable having an electrical conductor connected to one of the first or the second electrical connection pads;   a first bead on the first end of the substrate and encapsulating the first electrical connection pad; and   a second bead on the second end of the substrate and encapsulating the second electrical connection pad.   
     
     
         30 . A sensing apparatus of  claim 29 , where the first and second beads are spaced apart to define a recess between the beads, the spacing element being arranged in the recess between the beads. 
     
     
         31 . A sensing apparatus of  claim 24 , where the substrate has a first end and a second end and the sensor module further comprises:
 a first pair of electrical connection pads on the substrate, adjacent the first end of the substrate;   a second pair of electrical connection pads on the substrate, adjacent the second end of the substrate;   a cable having a pair of electrical conductors connected to one of the first or the second pair of electrical connection pads;   a first bead on the first end of the substrate and encapsulating the first pair of electrical connection pads; and   a second bead on the second end of the substrate and encapsulating the second pair of electrical connection pads.   
     
     
         32 . A sensing apparatus of  claim 24 , where:
 the spacing element has at least one portion that has an outer circumferential surface that extends outward from the substrate a distance further than the beads,   the sensing apparatus further comprises an outer tubing disposed over the sensor module, the outer tubing having an inner surface that presses against the at least one portion of the spacing element, and causes the spacing element to press against the substrate.   
     
     
         33 . A sensing apparatus of  claim 32 , where the outer tubing has a window arranged adjacent the catalyst receiving area of the spacing element. 
     
     
         34 . A method of making a sensing apparatus comprising making a sensing module comprising:
 providing a substrate having a first surface on which an electrode is disposed;   supporting a spacing element adjacent the electrode, the spacing element having a catalyst receiving area for receiving an enzyme and maintaining the catalyst a defined distance from the electrode.   
     
     
         35 . A method of  claim 34 , where making the sensor module further comprises coupling a pair of beads to the substrate in a spaced apart relation to define a recess between the beads, and arranging the spacing element in the recess between the beads. 
     
     
         36 . A method of  claim 35 , further comprising:
 providing an electrical connection pad on the substrate;   connecting a cable having an electrical conductor to the electrical connection pad; and   encapsulating the electrical connection pad with one of the beads.   
     
     
         37 . A method of  claim 36 , further comprising encapsulating a portion of the cable with said one of the beads. 
     
     
         38 . A method of  claim 35 , where the cable has a connector and a length dimension, and the method further comprises connecting the electrical connection pad of the sensor module to the cable at a location that is spaced apart from the connector such that the length dimension of the cable extends between the connector and the sensor module. 
     
     
         39 . A method of  claim 34 , where the substrate has a first end and a second end and the method of making the sensor module further comprises:
 providing a first electrical connection pad on the substrate, adjacent the first end of the substrate;   providing a second electrical connection pad on the substrate, adjacent the second end of the substrate;   connecting a cable having an electrical conductor to one of the first or the second electrical connection pads;   encapsulating the first electrical connection pad with a first bead on the first end of the substrate; and   encapsulating the second electrical connection pad with a second bead on the second end of the substrate.   
     
     
         40 . A method of  claim 39 , where the first and second beads are spaced apart to define a recess between the beads, the method further comprising arranging the spacing element in the recess between the beads. 
     
     
         41 . A method of  claim 34 , where the substrate has a first end and a second end and the method of making the sensor module further comprises:
 providing a first pair of electrical connection pads on the substrate, adjacent the first end of the substrate;   providing a second pair of electrical connection pads on the substrate, adjacent the second end of the substrate;   connecting a cable having a pair of electrical conductors to one of the first or the second pair of electrical connection pads;   encapsulating the first pair of electrical connection pads with a first bead on the first end of the substrate; and   encapsulating the second pair of electrical connection pads with a second bead on the second end of the substrate.   
     
     
         42 . A method of  claim 34 , where:
 the spacing element has at least one portion that has an outer circumferential surface that extends outward from the substrate a distance further than the beads,   the method of making the sensing apparatus further comprises disposing an outer tubing over the sensor module, the outer tubing having an inner surface that presses against the at least one portion of the spacing element, and causes the spacing element to press against the substrate.   
     
     
         43 . A method of  claim 42 , further comprising providing the outer tubing with a window and arranging the window adjacent the catalyst receiving area of the spacing element.