IMPLANTABLE SENSOR APPARATUS AND METHODS

• US 20170181674A1
• Filed: 12/29/2015
• Published: 06/29/2017
• 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
• Granted Patent: US 10,660,550 B2
• Time in Patent Office: 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 apparatus in a living entity, the method comprising:

obtaining a sensor apparatus, the sensor apparatus comprising a power supply, a plurality of sensing elements disposed substantially within a sensing region of the sensor apparatus, signal processing apparatus in data communication with the plurality of sensing elements, and a wireless interface in data communication with the signal processing apparatus, the sensor apparatus configured for monitoring of at least one physiological parameter indicative of a glucose level within the living entity;

forming an incision in the living entity at or proximate a desired implantation location;

forming a cavity within a portion of tissue of the living entity, at least a portion of the cavity disposed proximate a subcutaneous fascial layer of the living entity;

disposing the sensor apparatus at least partly within the cavity so that the sensing region of the sensor apparatus is (i) situated immediately proximate the subcutaneous fascial layer and in direct contact with tissue proximate the subcutaneous fascial layer, and (ii) oriented with the sensing region substantially facing the subcutaneous fascial layer; and

closing off at least the formed incision such that the implanted sensor apparatus is substantially contained and operable within the cavity.

2. The method of claim 1, wherein the sensor apparatus comprises a substantially continuous glucose sensor, the at least one physiological parameter comprises oxygen, and said method further comprises:

testing the sensor apparatus at least prior to or after said act of disposing; and

activating the sensor apparatus so that it can at least sense the at least one physiological parameter, and transmit data wirelessly, subsequent to said testing.

3. The method of claim 2, wherein the testing the sensor apparatus at least prior to or after said act of disposing comprises testing the sensor apparatus after said disposing and while the sensing region is in direct contact with tissue of the entity within the cavity.

4. The method of claim 1, wherein:

the forming an incision comprises forming the incision on a lower abdomen of the living entity, the formed incision disposed lateral to a midline of the living entity, and inferior to a umbilicus and superior to an inguinal ligament of the living entity; and

the forming the cavity comprises separating at least a first layer of subcutaneous tissue proximate to the subcutaneous 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 said midline and extends substantially superior from said incision.

5. The method of claim 4, wherein the first layer of subcutaneous tissue comprises adipose tissue, and the second layer comprises fascial tissue.

6. The method of claim 2, wherein the activating the sensor apparatus comprises enabling an internal electrical power source of the sensor apparatus to provide electrical current to one or more electrical components of the sensor apparatus.

7. The method of claim 1, wherein:

the sensor apparatus comprises a housing having a somewhat planar form factor including a height which is less than each of a width and a length of the housing; and

the disposing the sensor apparatus at least partly within the cavity so that the sensing region of the sensor apparatus is (i) situated immediately proximate the subcutaneous fascial layer and in direct contact with tissue proximate the fascial layer, and (ii) oriented with the sensing region substantially facing the subcutaneous fascial layer, comprises both (a) disposing the sensor apparatus such that the length and width of the housing reside substantially within a common plane, the common plane being substantially parallel to a plane formed by at least a portion of the subcutaneous fascial layer, and (b) anchoring the sensor apparatus to at least one anatomical feature of the living entity.

8. The method of claim 1, wherein the wireless interface comprises antenna apparatus disposed at least partly within the sensor apparatus and oriented such that radio frequency emissions from the antenna apparatus are at least partly directed away from circuitry supporting operation of the sensing region, and said disposing the sensor apparatus at least partly within the cavity so that the sensing region of the sensor apparatus is (i) situated immediately proximate the subcutaneous fascial layer and in direct contact with tissue proximate the fascial layer, and (ii) oriented with the sensing region substantially facing the subcutaneous fascial layer, facilitates both transmission of said radio frequency emissions from the living entity, and mitigation of interference of said emissions with the circuitry.

9. 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 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; and

closing off the perforation such that the implanted sensor is substantially contained and operable within the living entity.

10. The method of claim 9, wherein the sensor comprises a substantially continuous glucose sensor having a plurality of individual sensing elements disposed on a sensing region thereof, 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 tissue.

11. The method of claim 9, wherein:

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 sensing region being disposed within the at least portion of the cavity such that the sensing region is immediately proximate the fascia and in contact with tissue proximate thereto.

12. A method of providing therapy to a living being, the method comprising:

incising 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 incising;

disposing a sensor apparatus at least partly within the cavity so that the 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 incised portion such that the implanted sensor apparatus is substantially contained and operable within the living being;

receiving wireless communications from the sensor apparatus; and

injecting at least one therapy agent at a site on the abdomen at least proximate the incised portion;

wherein said disposition of said sensor apparatus in said desired position and orientation cooperate to mitigate one or more deleterious effects on operation of said sensor apparatus resulting from said injecting of said therapy agent.

13. The method of claim 12, wherein said sensor apparatus comprises a substantially continuous glucose sensor, and said therapy agent comprises insulin, and the method further comprises using the implanted sensor apparatus to measure blood glucose levels of the living being.

14. The method of claim 12, wherein:

said sensor apparatus comprises a plurality of sensing elements disposed substantially within a sensing region of the sensing apparatus, the sensing region being disposed only on one side of a housing of the sensor apparatus; and

said orientation comprises orienting the sensor apparatus such that said sensing region is facing substantially toward said at least one anatomical feature and away from an epidermal layer of said being.

15. The method of claim 12, wherein:

said at least one anatomical feature comprises a subcutaneous fascial layer;

said sensor apparatus comprises a plurality of sensing elements disposed substantially within a sensing region of the sensing apparatus, the sensing region being disposed only on one side of a housing of the sensor apparatus; and

said desired position comprises said sensing region being immediately proximate to said subcutaneous fascial layer.

16. 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 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;

subsequently re-incising the portion of the abdomen to explant the first sensor apparatus from the living being;

disposing a second sensor apparatus at least partly within a 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 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.

17. The method of claim 16, wherein:

the re-incising comprises utilizing substantially the incision; and

the disposing a second sensor apparatus at least partly within a cavity comprises disposing the second sensor apparatus within the cavity within which the first sensor apparatus was disposed.

18. The method of claim 16, wherein the re-incising, and the disposing the second sensor apparatus within the cavity within which the first sensor apparatus was disposed, cooperate to reduce the propensity for thickening of the fibrous encapsulation of the sensor apparatus by the living being as part of the method.

19. The method of claim 16, 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 can continue substantially uninterrupted.

20. The method of claim 19, wherein 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 disposing the second sensor apparatus in the cavity.

21. 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 the solid 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 at the extant incision location to explant the first sensor apparatus from the living being;

disposing a second sensor apparatus at least partly within a 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.

22. The method of claim 21, wherein the cavity within which said first sensor apparatus is at least partly implanted and the cavity within which the second sensor apparatus is at least partly disposed comprise the same cavity.

23. A sensor apparatus configured for implantation within tissue of a living being, the sensor apparatus comprising:

a substantially biocompatible housing;

at least one sensing element disposed at least partly on an outer surface of the housing and configured such that the sensing element can sense at least one analyte when placed in contact with at least a portion of the tissue;

signal processing apparatus in signal communication with the at least one sensing element and configured to process signals generated by the at least one sensing element;

wherein said sensor apparatus is configured to be implanted within said tissue such that said sensor apparatus is disposed proximate a fascial or musculature layer of the living being, and operate with the at least one sensing element also proximate the fascial or musculature layer.

24. The sensor apparatus of claim 23, wherein said configuration to operate with the at least one sensing element proximate the fascial or musculature layer comprises the at least sensing one sensing element being disposed on only one of a plurality of sides of the housing so as at to permit the sensing apparatus, when implanted, to maintain the at least sensing element substantially facing the fascial or musculature layer.

25. The sensor apparatus of claim 24, wherein said housing comprises a substantially planar structure having a first substantially planar face and a second substantially planar face, the at least one sensing element disposed on only the first substantially planar face.

26. The sensor apparatus of claim 23, wherein the at least one sensing element comprises a plurality of sensor elements configured to provide oxygen-based glucose measurement of the tissue without either of (i) exposure of the tissue to any significant electrical current or potential;

or (ii) exposure of the tissue to any significant concentration of peroxides.

27. The sensor apparatus of claim 23, wherein the fascial or musculature layer comprises a fascial layer immediately proximate a musculature layer disposed within the solid abdominal tissue of the living being.

28. The sensor apparatus of claim 23, wherein the at least one sensing element comprises a plurality of sensor elements configured to provide oxygen-based glucose measurement of the tissue, said oxygen-based measurement and said biocompatibility of the housing cooperating to mitigate foreign body response (FBR) by the tissue.