Tissue-integrating sensors
Inventors
Wisniewski, Natalie A. • Helton, Kristen • McMillan, William A.
Assignees
Publication Number
US-10463287-B2
Publication Date
2019-11-05
Expiration Date
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Abstract
Tissue-integrating biosensors, systems comprising these sensors and methods of using these sensors and systems for the detection of one or more analytes are provided.
Core Innovation
Disclosed herein are tissue-integrating biosensors, systems comprising these sensors and methods of using these sensors and systems for the detection of one or more analytes. In one aspect, provided herein are a tissue-integrating sensor for detecting an analyte, the sensor comprising a tissue-integrating scaffold; and one or more sensing moieties, wherein the sensing moieties produce a detectable signal in the presence of the analyte; and further wherein the sensor provides detection of the analyte when placed (e.g., implanted) into the tissue of a subject. The tissue-integrating sensors as described herein can provide long-term detection of the analyte(s), and the tissue-integrating scaffold can consist of the one or more sensing moieties (e.g., polymeric sensing moieties formed into a scaffold). The tissue-integrating sensors may comprise one or more polymers, for example one or more hydrogels, and the sensing moieties may be embedded and/or attached to the exterior of the scaffold or may form the scaffold itself.
The background identifies that current implanted sensors typically fail after a relatively short period of time due to electrical failure, degradation of the analyte recognition element, component degradation and delamination, or changes in the tissue immediately adjacent to the sensor that render the interface unrepresentative of the overall body state. Individual sensing particles can be ingested by macrophages and removed from the implant site or, if too large, undergo a foreign body response that limits capillary proximity; as sensors become encapsulated by avascular tissue or engulfed by phagocytic cells they lose ability to accurately sense blood-borne analytes. Thus there remains a need for sensing technologies that are tissue integrating to provide long-term (e.g., weeks, months or years) and accurate readings by remaining in contact with interstitial fluid and remaining in close proximity to the vasculature so that the interstitial fluid surrounding the sensor is in constant rapid equilibrium with nearby capillaries.
Claims Coverage
Independent claims identified: 1, 8 and 13. The following inventive features (6 total) are extracted from these independent claims.
Sensor devoid of electronics
The entire sensor being devoid of electronics and including a sensing moiety configured to produce an emission signal in the presence of an analyte.
Tissue-integrating scaffold with hollow, interconnected pores
A tissue-integrating scaffold including the sensing moiety, the tissue-integrating scaffold defining a plurality of hollow, interconnected pores.
Physically spaced module for transcutaneous excitation and detection
A module, physically spaced apart from the sensor, configured to (1) send an excitation signal that diffuses through tissue to the sensor and excites the moiety and (2) receive the emission signal produced by the sensing moiety after the emission signal has diffused through the tissue.
Hydrogel scaffold promoting space-filling tissue ingrowth
A hydrogel scaffold defining a plurality of hollow, interconnected pores configured such that, when the hydrogel scaffold is placed into tissue of a subject, the plurality of hollow, interconnected pores promote space-filling ingrowth of tissue.
Sensing moiety disposed within hydrogel scaffold
A sensing moiety disposed within the hydrogel scaffold and configured to produce a signal in a presence of an analyte.
Scaffold containing plurality of sensing moieties positioned near blood vessels
A plurality of sensing moieties configured to produce a signal in a presence of an analyte and a tissue-integrating scaffold containing the plurality of sensing moieties, the tissue-integrating scaffold defining a plurality of interconnected pores such that at least a subset of the sensing moieties disposed in an interior of the tissue-integrating scaffold are in close proximity to blood vessels when the tissue-integrating sensor is placed into a tissue of a subject.
The independent claims cover systems and apparatuses in which sensing moieties are combined with tissue-integrating scaffolds that define hollow, interconnected pores to promote tissue and capillary ingrowth, sensors lacking electronics with remote modules for excitation and detection, hydrogel scaffolds configured for space-filling tissue ingrowth, and scaffolds containing plural sensing moieties positioned in close proximity to blood vessels.
Stated Advantages
Integration of devices into the subject through tissue and/or capillary in-growth, minimizing foreign body response and promoting vascularization.
Improved accuracy and reduced lag time due to integration of capillaries into and throughout the sensor (capillary enhancement).
Provision of long-term accurate assessment of analytes for greater than a week, typically weeks, months or years.
Ability to be implanted through syringe injection, meaning that no surgery is required to put the sensing media in place in the body.
Sensors that do not include sensor electronics in the body.
Use of materials having properties more similar to actual tissue (e.g., modulus more similar to tissue's modulus and hydrogel water content) to allow better acceptance into the tissue.
Small dimensions which result in increased patient comfort and better acceptance by the body.
Documented Applications
Continuous or semi-continuous monitoring of glucose for management of diabetes, to provide reliable and accurate self-monitoring of blood glucose levels without regular blood draws.
Monitoring of various endogenous analytes including oxygen, reactive oxygen species, lactate, pyruvate, cortisol, creatinine, urea, ions, hormones, pH, cytokines, chemokines, proteins, nucleic acids and the like.
Monitoring of exogenous substances including therapeutic drugs and chemotherapeutic agents, food additives, sodium, alcohol, caffeine, nicotine, vitamins, lead, pesticides, and other substances to inform dosing and exposure.
Use in personal monitoring, physician monitoring of patients, clinical research, animal research studies, and veterinary health for continuously or semi-continuously monitoring analyte concentrations inside a living body.
Integration with systems that include remote interrogators/readers and optional delivery devices to enable closed-loop therapies, for example an insulin pump controlled by sensor measurements to form a closed loop artificial pancreas.
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