Tissue-integrating sensors
Inventors
Wisniewski, Natalie A. • Helton, Kristen • McMillan, William A.
Assignees
Publication Number
US-10117613-B2
Publication Date
2018-11-06
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
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. 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.
Currently, continuous analyte sensors for monitoring body chemistry do not provide accurate, long-term data due to the progressively declining capillary density and/or foreign body response. Thus, there remains a clear 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 (not the internal cellular environment) and remaining in close proximity to the vasculature so that the interstitial fluid surrounding the sensor is in constant rapid equilibrium with nearby capillaries.
The integration of capillaries into and throughout the sensor (sensing media) is a major improvement over what currently exists, giving rise to improved accuracy and reduced lag time. The tissue-integrating sensors described herein remain in good contact (close proximity) to blood vessels and have direct access to measurements of interstitial fluid, and the sensing media is devoid of electronics. Additionally the tissue-integrating sensing media may have a modulus closer to the texture of tissue, thus enhancing the integration in the tissue.
Claims Coverage
This coverage identifies independent claims 1, 17, and 28 and extracts seven main inventive features from those independent claims.
Hydrogel scaffold defining a plurality of hollow, interconnected pores
a hydrogel scaffold defining a plurality of hollow, interconnected pores such that capillaries can grow directly into the hydrogel scaffold;
Sensing moieties disposed within the hydrogel scaffold
one or more sensing moieties disposed within the hydrogel scaffold, a sensing moiety from the one or more sensing moieties configured to produce a signal in a presence of an analyte.
Hydrogel tissue-integrating scaffold configured for capillary ingrowth
a hydrogel, tissue-integrating scaffold defining a plurality of hollow, interconnected pores configured such that capillaries can grow directly into the hydrogel, tissue-integrating scaffold;
Sensing moiety included within the hydrogel tissue-integrating scaffold
a sensing moiety included within the hydrogel, tissue-integrating scaffold, the sensing moiety configured to produce a signal in a presence of an analyte.
Hydrogel scaffold having a single layer defining interconnected pores
a hydrogel scaffold having a single layer defining a plurality of interconnected pores such that capillaries can grow directly into the hydrogel scaffold;
Sensing moieties disposed within the single-layer hydrogel scaffold
one or more sensing moieties disposed within the hydrogel scaffold, a sensing moiety from the one or more sensing moieties configured to produce a signal in the presence of an analyte;
Calibration moieties disposed within the hydrogel scaffold
one or more calibration moieties disposed within the hydrogel scaffold, a calibration moiety from the one or more calibration moieties configured to produce a signal when illuminated by an excitation light.
The independent claims principally recite a hydrogel, tissue-integrating scaffold with hollow, interconnected pores configured to support capillary ingrowth together with one or more sensing moieties disposed within the scaffold configured to produce a signal in the presence of an analyte; claim 28 further includes one or more calibration moieties disposed within the hydrogel scaffold.
Stated Advantages
Providing devices that integrate into the subject (e.g., through tissue and/or capillary in-growth).
Providing devices which can be implanted through syringe injection, meaning that no surgery is required to put the sensing media in place in the body.
Providing devices that do not include sensor electronics in the body.
Providing devices comprising material(s) having properties more similar to actual tissue (e.g., modulus that is more similar to tissue's modulus and hydrogel water content) to allow a better acceptance into the tissue.
Providing devices that accurately assess analyte(s) for long periods of time (e.g., greater than a week, typically weeks, months or years).
Providing devices of small dimensions which will give result in increased patient comfort and better acceptance by the body.
Documented Applications
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.
Monitoring diabetic health, including continuous glucose monitoring to improve health outcomes.
Monitoring dehydration and hemodialysis.
Monitoring acute respiratory distress and stress assessment.
Monitoring congestive heart failure, metabolism status, and lifestyle, fitness and training.
Monitoring peripheral vascular resistance and hyonatramia.
Monitoring acute decompensated heart failure and fertility status (e.g., ovulation cycle).
Cancer detection (early, recurrent, etc.) and inflammatory responses (various types).
Therapeutic drug monitoring, including drug concentrations or drug response indicators.
Monitoring ethanol for alcoholism treatment, infection disease monitoring, pesticide monitoring, and heavy metal monitoring.
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