Implantable sensor apparatus and methods

• US 10,660,550 B2
• Filed: 12/29/2015
• Issued: 05/26/2020
• Est. Priority Date: 12/29/2015
• Status: Active Grant

• Current Assignee: Mcnair Interests Limited
• Original Assignee: GlySens, Incorporated
• Inventors: Lucisano, Joseph, Wilensky, Jonathan, Engler, Robert
• Primary Examiner(s): Messersmith, Eric J
• Application Number:
  US14/982,346
• Publication Number:
  US 20170181674A1
• Time in Patent Office: 1,610 Days
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0015 characterised by features of the telemetry system
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61M 2210/1021 Abdominal cavity
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

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.

Claims

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.

2. The method of claim 1, wherein the sensor comprises a substantially continuous glucose sensor, and the at least one non-peroxide, oxygen-based glucose sensing element comprises a plurality of individual non-peroxide, oxygen-based glucose sensing elements disposed in the first sensing region;

and

wherein the method further comprises disposing the sensor within the cavity so that it is both (i) situated in the desired position relative to the at least one anatomical feature, and (ii) oriented with the sensing region thereof substantially facing away from an epidermal layer of the living entity overlying the portion of the accessed tissue.

3. The method of claim 1, wherein:

the forming the cavity comprises forming the cavity so that at least a portion thereof is immediately proximate a fascia of the living entity; and

the desired position relative to at least one anatomical feature comprises the first sensing region being disposed within the at least portion of the cavity such that the first sensing region is immediately proximate the fascia and in contact with tissue proximate thereto.

4. The method of claim 1, wherein the perforating the outer layer of tissue of the living entity comprises forming an incision on a lower abdomen of the living entity, the formed incision disposed lateral to a midline of the living entity, and inferior to an umbilicus and superior to an inguinal ligament of the living entity.

5. The method of claim 4, wherein the forming the cavity comprises separating at least a first layer of subcutaneous tissue proximate to a superficial fascial layer from a second layer of subcutaneous tissue without any significant cutting or removal of tissue, the cavity formed such that a longitudinal axis of the cavity is substantially parallel to the midline and extends substantially superior from the incision.

6. The method of claim 5, wherein the first layer of subcutaneous tissue comprises adipose tissue, and the second layer of subcutaneous tissue comprises at least one of muscular fascia tissue or muscular tissue.

7. The method of claim 1, wherein the minimizing the tissue response effect of the implanted sensor on the accessed tissue at least in part comprises implanting the sensor beneath an adipose tissue layer of the living subject.

8. The method of claim 1, wherein:

the sensor comprises an oxygen-based glucose sensor; and

the minimizing the tissue response effect of the implanted sensor on the accessed tissue at least in part comprises enabling long-term implantation of the oxygen-based glucose sensor via a face of the sensor contacting oxygen-rich tissue below an adipose tissue layer of the living entity.

9. The method of claim 1, wherein the implanting the new sensor such that the second sensing region thereof is positioned at the contoured site at least in part comprises enhancing mechanical coupling between the new sensor and the accessed tissues, thereby minimizing a subsequent tissue response effect of the new implanted sensor on the accessed tissue.

10. A method of providing treatment to a living being, the method comprising:

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.

11. The method of claim 10, wherein the subsequently re-incising comprises substantially utilizing the incision.

12. The method of claim 11, wherein the subsequently re-incising, and the disposing the second sensor apparatus within the cavity within which the first sensor apparatus was previously disposed, cooperate to reduce the propensity for thickening of the fibrous encapsulation of the second sensor apparatus by the living being as part of the method.

13. The method of claim 10, wherein the subsequently re-incising is performed before expiry of the first period of time such that said monitoring of the at least one physiological parameter associated with the living being continues substantially uninterrupted.

14. The method of claim 13, wherein the utilizing the second sensor apparatus to monitor the at least one physiological parameter associated with the living being for a second period of time comprises commencing the second period of time before said closing off of the cavity after the disposing of the second sensor apparatus at least partly within the cavity.

15. The method of claim 10, wherein the forming the incision in the portion of the abdomen comprises forming an incision on a lower abdomen of the living being, the formed incision disposed lateral to a midline of the living being, and inferior to an umbilicus and superior to an inguinal ligament of the living being.

16. The method of claim 15, wherein the forming the cavity comprises separating at least a first layer of subcutaneous tissue proximate to a superficial fascial layer from a second layer of subcutaneous tissue without any significant cutting or removal of tissue, the cavity formed such that a longitudinal axis of the cavity is substantially parallel to the midline.

17. The method of claim 16, wherein the first layer of subcutaneous tissue comprises adipose tissue, and the second layer of subcutaneous tissue comprises at least one of muscular fascia tissue or muscular tissue.

18. The method of claim 10, wherein the minimizing of the tissue response effect at least in part comprises utilizing one or more oxygen-based sensing elements for the monitoring of the at least one physiological parameter, and thereby limiting exposure of the tissue to peroxide byproducts during the monitoring.

19. A method of implanting a replacement blood analyte sensor in a living entity, the method comprising:

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.

20. The method of claim 19, wherein the positioning each of the one or more external features of the second sensing region of the replacement blood analyte sensor into the corresponding shape within the contoured portion of the tissue enhances mechanical coupling of the replacement blood analyte sensor with the tissue of the living entity.

21. The method of claim 19, wherein the forming the incision in the portion of the abdomen comprises forming an incision on a lower abdomen of the living entity, the formed incision disposed lateral to a midline of the living entity, and inferior to an umbilicus and superior to an inguinal ligament of the living entity.

22. The method of claim 19, wherein the disposing the replacement blood analyte sensor at least partly within the cavity is performed before expiry of the first period of time such that monitoring of the at least one blood analyte within the living entity continues substantially uninterrupted.

23. The method of claim 19, wherein disposing the replacement blood analyte sensor at least partly within the cavity at least in part comprises positioning the replacement blood analyte sensor such that the second sensing region thereof is oriented toward the muscular fascia layer.

24. The method of claim 19, wherein the disposing the replacement blood analyte sensor at least partly within the cavity, within which the at least one blood analyte sensor was previously disposed, reduces a propensity for thickening of fibrous encapsulation of the replacement blood analyte sensor apparatus by the living entity.

25. The method of claim 19, wherein the disposing the replacement blood analyte sensor at least partly within the cavity, within which the at least one blood analyte sensor was previously disposed, reduces foreign body response to the replacement blood analyte sensor by the living entity.