Implantable sensor apparatus and methods
First Claim
1. A method of implanting a sensor in a living entity, the sensor configured for monitoring of at least one physiological parameter, the method comprising:
- perforating an outer layer of tissue of the living entity so as to gain access to tissue below;
forming a cavity within a portion of the accessed tissue;
disposing the sensor at least partly within the cavity so that the sensor is situated in a desired position relative to at least one anatomical feature of the living entity, the sensor comprising at least one non-peroxide, oxygen-based glucose sensing element disposed in a first sensing region thereof;
closing off the perforation such that the implanted sensor is substantially contained and operable within the living entity;
operating the implanted sensor for a period of time to monitor the at least one physiological parameter;
minimizing a tissue response effect of the implanted sensor on the accessed tissue, thereby limiting a foreign body response of the accessed tissue and allowing the accessed tissue contour around the sensor and form a contoured site, the minimizing the tissue response effect at least in part comprising limiting exposure of the tissue to any significant concentration of peroxides via utilizing the at least one non-peroxide, oxygen-based glucose sensing element for the operating of the implanted sensor for the period of time to monitor the at least one physiological parameter, the contoured site comprising a shape corresponding to one or more surface features of the sensing region; and
after the period of time, explanting the sensor while substantially maintaining the shape of the contoured site corresponding to the one or more surface features of the first sensing region, and implanting a new sensor such that a second sensing region thereof is positioned into the shape corresponding to the one or more surface features of the first sensing region at the contoured site.
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Accused Products
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.
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Citations
25 Claims
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1. A method of implanting a sensor in a living entity, the sensor configured for monitoring of at least one physiological parameter, the method comprising:
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perforating an outer layer of tissue of the living entity so as to gain access to tissue below; forming a cavity within a portion of the accessed tissue; disposing the sensor at least partly within the cavity so that the sensor is situated in a desired position relative to at least one anatomical feature of the living entity, the sensor comprising at least one non-peroxide, oxygen-based glucose sensing element disposed in a first sensing region thereof; closing off the perforation such that the implanted sensor is substantially contained and operable within the living entity; operating the implanted sensor for a period of time to monitor the at least one physiological parameter; minimizing a tissue response effect of the implanted sensor on the accessed tissue, thereby limiting a foreign body response of the accessed tissue and allowing the accessed tissue contour around the sensor and form a contoured site, the minimizing the tissue response effect at least in part comprising limiting exposure of the tissue to any significant concentration of peroxides via utilizing the at least one non-peroxide, oxygen-based glucose sensing element for the operating of the implanted sensor for the period of time to monitor the at least one physiological parameter, the contoured site comprising a shape corresponding to one or more surface features of the sensing region; and after the period of time, explanting the sensor while substantially maintaining the shape of the contoured site corresponding to the one or more surface features of the first sensing region, and implanting a new sensor such that a second sensing region thereof is positioned into the shape corresponding to the one or more surface features of the first sensing region at the contoured site. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method of providing treatment to a living being, the method comprising:
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forming an incision in a portion of an abdomen of the living being; forming a cavity within a portion of the solid tissue of the living being accessible via the incision; disposing a first sensor apparatus at least partly within the cavity so that the first 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 a portion of the formed incision such that the first sensor apparatus is substantially contained and operable within the living being; utilizing the first sensor apparatus to monitor at least one physiological parameter associated with the living being for a first period of time and enabling the tissue to form a contoured portion around one or more first external features of the first sensor apparatus during the first period of time; minimizing a tissue response effect of the first sensor apparatus on the accessed tissue, thereby limiting a foreign body response of the accessed tissue; subsequently re-incising the portion of the abdomen and explanting the first sensor apparatus from the living being while maintaining the contoured portion of the tissue, the explanting of the first sensor apparatus from the living being while maintaining the contoured portion of the tissue enabled at least in part by the minimizing of the tissue response effect; disposing a second sensor apparatus at least partly within the cavity within which the first sensor apparatus was previously disposed so that the second sensor apparatus is situated in the desired position and orientation relative to the at least one anatomical feature of the living being, the disposing of the second sensor apparatus comprising; identifying the contoured portion of the tissue within the cavity; and positioning each of one or more second external features of the second sensor apparatus into a corresponding shape within the contoured portion of the tissue; closing off the re-incised portion 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 second period of time. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18)
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19. A method of implanting a replacement blood analyte sensor in a living entity, the method comprising:
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forming an incision in a portion of an abdomen of the living entity so as to gain access to a cavity in tissue below, the cavity disposed between a layer of adipose tissue proximate to a superficial fascial layer and a muscular fascia layer, the cavity having at least one blood analyte sensor disposed therein, the at least one blood analyte sensor having been operated within the living entity for a first period of time to monitor signals related to at least one blood analyte; removing the at least one blood analyte sensor from the cavity; disposing the replacement blood analyte sensor at least partly within the cavity within which the at least one blood analyte sensor was previously disposed; closing off the incision such that the replacement sensor blood analyte sensor is substantially contained and operable within the living entity; and operating the replacement blood analyte sensor within the living entity for a second period of time to monitor subsequent signals related to the at least one blood analyte; wherein the disposing the replacement blood analyte sensor at least partly within the cavity at least in part comprises; identifying a contoured portion of the tissue in the muscular fascia layer which has contoured to at least a shape of a first sensing region of the at least one blood analyte sensor without encouraged foreign body response; and positioning each of one or more external features of a second sensing region of the replacement blood analyte sensor into a corresponding shape within the contoured portion of the tissue in the muscular fascia layer. - View Dependent Claims (20, 21, 22, 23, 24, 25)
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Specification