Tissue-integrating electronic apparatus
Inventors
Wisniewski, Natalie A. • Petersen, Kurt E. • Helton, Kristen • McMillan, William A.
Assignees
Publication Number
US-10010272-B2
Publication Date
2018-07-03
Expiration Date
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Abstract
Tissue-integrating electronic apparatuses, systems comprising such apparatuses and methods of using these apparatuses and systems for the detection of one or more signals are provided.
Core Innovation
Tissue-integrating electronic apparatuses, systems comprising these apparatuses and methods of using these apparatuses and systems to generate and measure various signals are provided. In an embodiment, a tissue-integrating apparatus includes a tissue-integrating scaffold including a flexible wire and a sensor operatively coupled to the flexible wire and integrated with the scaffold, the sensor configured to produce a detectable signal.
The invention addresses the problem that implanted sensors and other implants elicit inflammatory and immune responses that lead to protein fouling, granulation tissue formation and eventual formation of an avascular capsule, which causes loss of analyte availability to the sensor and loss of sensor sensitivity. Existing approaches have limited durability because delivered tissue response modifiers are finite, large implants exacerbate the foreign body response, and no known materials or drugs remain stable in vivo for multi-year durations.
The apparatuses and systems are described as tissue-integrating and tissue anchoring, with scaffolds and components that encourage cellular integration and capillary ingrowth so that the apparatus remains in close proximity to blood vessels and interstitial fluid. Systems include one or more tissue-integrating apparatuses and an implantable module and may include external devices; the described sensors may be opto-electronic or electrochemical and may include light sources, detectors, electrodes and additional sensors.
Claims Coverage
The patent includes two independent apparatus claims. The main inventive features extracted from the independent claims are listed below.
Fabric, tissue-integrating scaffold
A fabric, tissue-integrating scaffold.
Flexible wire woven through the scaffold
A flexible wire woven through the fabric, tissue-integrating scaffold.
Analyte-sensing tissue-integrating electrode coupled to the flexible wire
An analyte-sensing, tissue-integrating electrode coupled to the flexible wire.
Flexible wire configured to conduct an electrical signal associated with an analyte
The flexible wire being configured to conduct at least one electrical signal flowing through the analyte-sensing, tissue-integrating electrode, the at least one electrical signal being associated with an amount of an analyte.
Flexible wire embedded within a tissue-integrating scaffold
A flexible wire embedded within the tissue-integrating scaffold and coupled to the analyte-sensing, tissue-integrating electrode.
Analyte-sensing, tissue-integrating electrode
An analyte-sensing, tissue-integrating electrode (as a component of the scaffold/electrode assembly).
The independent claims principally disclose a tissue‑integrating scaffold containing or woven with a flexible wire and an analyte‑sensing tissue‑integrating electrode, where the flexible wire conducts electrical signals associated with an amount of an analyte.
Stated Advantages
Providing devices that integrate into the subject through tissue and/or capillary in-growth.
Providing devices having at least one component that anchors or holds the systems in place to or within the tissue of the subject.
Providing devices that can be implanted through syringe injection, meaning that no surgery is required to put the sensing media in place in the body.
Providing devices having material(s) having properties more similar to actual tissue to allow a better integration 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 that result in increased patient comfort and better acceptance by the body.
Documented Applications
Detection and measurement of one or more signals including analyte, electrical, optical, mechanical, magnetic and/or thermal signals in an in vivo sample.
Continuous or semi-continuous in vivo monitoring of analytes to improve management of acute or chronic illnesses, including glucose monitoring for diabetes.
Simultaneous and continuous monitoring of lactate and glucose for trauma and congestive heart failure patients to facilitate detection of occult bleeding and changes in shock status.
Real-time monitoring of drug concentrations during systemic administration to provide feedback for dosing adjustments.
Implantable devices such as sensors, drug delivery devices, pumps and chips, including opto-electronic and electrochemical tissue-integrating sensors.
Systems comprising one or more tissue-integrating apparatuses and an implantable module, optionally with an external device for power, interrogation, data processing and display.
Methods for directing a localized biological response of a mammalian body to an implant, including prolonging useful life of an implant, facilitating removal of an implant, and preparing tissue for implantation.
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