Implantable sensor apparatus and methods

Abstract

Implantable sensor apparatus and methods of implantation. In one embodiment, a fully implantable, biocompatible sensor is disposed within a cavity or pocket formed within a living being, such that the sensor remains in a desired orientation and placement so as to enhance the performance of the sensor, and mitigate the effects of one or more factors potentially deleterious to the operation of the sensor and the host being. In one implementation, the sensor comprises an implantable biocompatible oxygen-based glucose sensor which is implanted deep within the being's torso tissue proximate the extant fascia, and oriented such that an active detector aspect of the device faces away from the being's skin surface. In one variant, the deep placement, orientation, and construction of the sensor itself cooperate to enhance the performance of the sensor, especially over extended periods of time, with little need for external calibration.

1 .- 28 . (canceled) 
     
     
         29 . A method of providing treatment to a living being, the living being having a first sensor apparatus implanted at least partly within a cavity formed in a tissue of the living being, the method comprising:
 identifying an extant incision location on the living being, the extant incision having been previously used for implantation of the first sensor apparatus within the cavity;   forming an incision at least partly at the extant incision location to explant the first sensor apparatus from the living being;   disposing a second sensor apparatus at least partly within the cavity so that the second sensor apparatus is situated in a desired position and orientation relative to at least one anatomical feature of the living being;   closing off at least the formed incision so that the second sensor apparatus is substantially contained and operable within the living being; and   utilizing the second sensor apparatus to monitor the at least one physiological parameter associated with the living being for a period of time.   
     
     
         30 .- 31 . (canceled) 
     
     
         32 . The method of  claim 29 , wherein the utilizing the second sensor apparatus to monitor the at least one physiological parameter associated with the living being for a period of time comprises utilizing at least one oxygen-based glucose sensing element of the second sensor apparatus to monitor the at least one physiological parameter. 
     
     
         33 . The method of  claim 32 , wherein the utilizing the at least one oxygen-based glucose sensing element comprises substantially mitigating a foreign body response of the tissue to the second sensor apparatus by obviating peroxide-based substances contacting the tissue. 
     
     
         34 . The method of  claim 29 , wherein:
 the second sensor apparatus comprises at least one round side and at least one flat side opposite the round side; and the disposing a second sensor apparatus at least partly within the cavity comprises inserting the second sensor apparatus into the incision via the at least one round side of the second sensor apparatus.   
     
     
         35 . The method of  claim 34 , wherein:
 the forming an incision comprises forming a transverse incision; and   the situating the second sensor apparatus comprises situating the second sensor apparatus such that the second sensor apparatus is vertically oriented with respect to transverse incision.   
     
     
         36 . The method of  claim 29 , wherein the forming the incision comprises forming the incision on a lower abdomen of the living entity, the formed incision disposed lateral to a midline of the living being, and inferior to a umbilicus and superior to an inguinal ligament of the living being. 
     
     
         37 . The method of  claim 29 , wherein:
 an external portion of a sensor region of the first sensor element and an external portion of a sensor region of the second sensor element are substantially identical; and   the disposing the second sensor apparatus at least partly within the cavity comprises disposing the second sensor apparatus within the cavity within which the first sensor apparatus was previously disposed such that the external portion of the second sensor element is disposed within one or more features formed in the tissue by the external portion of the first sensor element while implanted.   
     
     
         38 . The method of  claim 37 , wherein the forming the incision at least at the extant incision location and the disposing the second sensor apparatus within the cavity within which the first sensor apparatus was previously disposed, cooperate to reduce a propensity for thickening of a fibrous encapsulation of the second sensor apparatus by the living being. 
     
     
         39 . The method of  claim 29 , wherein the disposing the second sensor apparatus comprises situating the second sensor apparatus proximate to a subcutaneous fascial layer of the tissue of the living being, with a sensing portion of the second sensor apparatus facing the subcutaneous fascial layer. 
     
     
         40 . The method of  claim 39 , wherein the utilizing the second sensor apparatus to monitor the at least one physiological parameter associated with the living being for a period of time comprises causing the sensing region to maintain contact with tissue proximate the subcutaneous facial layer for the period of time. 
     
     
         41 . A method of providing treatment to a living being, comprising:
 forming an incision within abdominal tissue of the living being so as to access a fascial layer of the living being, the fascial layer disposed within the abdomen of the living being;   forming a pocket a prescribed depth within the abdomen and proximate the fascial layer, the pocket formed to at least partly receive a blood glucose sensor apparatus;   disposing the blood glucose sensor at least partly within the pocket such that an active sensor face or portion of the sensor apparatus faces the fascial layer; and   activating the blood glucose sensor to be operable within the living being; and   closing at least a portion of the incision;   wherein the forming a pocket at a prescribed depth within the abdomen and proximate the fascial layer and the disposing of the blood glucose sensor at least partly within the pocket, provides insensitivity of the blood glucose sensor to one or more topically or locally administered therapeutic agents.   
     
     
         42 . The method of  claim 41 , further comprising:
 injecting the one or more topically or locally administered therapeutic agents at a site at least proximate to the incision; and   operating the blood glucose sensor to obtain at least data relating to a blood glucose level of the living being.   
     
     
         43 . The method of claim  30 , wherein the forming the pocket at a prescribed depth within the abdomen comprises separating adipose tissue from the fascial layer, such that little or no tissue removal occurs, in order to minimize tissue and blood vessel trauma. 
     
     
         44 . The method of claim  30 , wherein the forming the pocket at a prescribed depth within the abdomen comprises forming the pocket at a depth selected to eliminate a salient visible protrusion of the abdomen proximate the formed incision. 
     
     
         45 . The method of claim  30 , wherein the forming the pocket at a prescribed depth within the abdomen comprises forming the pocket at a depth selected to place a sensing region of the blood glucose sensor proximate a region of high solute availability within the tissue. 
     
     
         46 . The method of claim  30 , wherein the forming the pocket at a prescribed depth within the abdomen comprises forming the pocket at a depth selected to expose the blood glucose sensor to a prescribed level of blood oxygen so as to enhance an operating range of the blood glucose sensor. 
     
     
         47 . A method of providing treatment to a living being, comprising:
 evaluating first data relating at least a depth of implantation of a blood glucose sensor within a living being to a level of experienced foreign body response (FBR);   based at least on the first data, identifying a target location for implantation of the blood glucose sensor, the target location including a target depth;   forming an incision within abdominal tissue of the living being so as to access a fascial layer of the living being, the fascial layer disposed at or proximate to the target depth;   forming a pocket proximate the fascial layer to at least partly receive a blood glucose sensor apparatus;   disposing the blood glucose sensor at least partly within the pocket;   activating the blood glucose sensor to be operable within the living being; and   closing at least a portion of the incision.   
     
     
         48 . The method of  claim 47 , wherein the identifying the target location for implantation extends the operational lifetime of the blood glucose sensor within the living being relative to an operational lifetime obtained from implantation of the blood glucose sensor at another depth, the another depth having a greater level of FBR associated therewith as compared to a level of FBR at the target depth. 
     
     
         49 . The method of  claim 47 , wherein the identifying the target location for implantation comprises identifying a location that provides substantial insensitivity of the blood glucose sensor to ingested or locally injected therapeutic agents. 
     
     
         50 . The method of  claim 47 , wherein the evaluating first data relating at least a depth of implantation of a blood glucose sensor within a living being to a level of experienced foreign body response (FBR) comprises evaluating data relating to a level of encapsulation of an implanted sensor obtained after explant thereof for at least one living being. 
     
     
         51 . The method of  claim 47 , wherein the blood glucose sensor comprises a plurality of sensor elements, and the method further comprises executing, after said activating, at least one computer program operative to execute on the blood glucose sensor, the at least one computer program causing:
 (i) evaluating of data from each of the individual sensor elements over a period of time for one or more effects of foreign body response; and   (ii) based at least on the evaluating, causing compensation for the one or more effects.