Gateway platform for biological monitoring and delivery of therapeutic compounds

Abstract

The invention relates to methods and devices for remote or distributed continuous monitoring of physiologically relevant states. The invention provides for methods to automatically detect deviations or other states in physiological parameters and automatically alert a measured subject, user or other authorized party. The device provides for a universal platform for sensors, and further provides for the automatic compensation or distribution of devices or bioactive agents at appropriate levels and / or intervals in response to deviations or other states sensed in various physiological parameters.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. application Ser. No. 10 / 032,765 filed Oct. 29, 2001, which claims the benefit of U.S. Provisional Application Ser. No. 60 / 301,897, filed Jun. 29, 2001. These applications are incorporated by reference in their entireties.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to methods and devices for remote or distributed monitoring of physiological states. The invention provides for methods to detect deviations in physiological parameters through the establishment of baseline values, either by direct inspection of compiled data or by computer aided analysis. The device provides for a universal platform for sensors, which may also allow automatic compensation or distribution of devices or bioactive agents at appropriate levels and / or intervals in response to deviations sensed in various physiological parameters. [0004] 2. Description of the Related Art [0005...

AI Technical Summary

Benefits of technology

[0011] One aspect of this invention is a device which automatically and continuously or periodically monitors physiological conditions in vivo using surface or sub-surface implanted sensors linked to CCM's and DCU's. By continuously monitoring physiological parameters remotely or in a distributed environment, baseline or reference data can be obtained, allowing detection of deviations in measured subjects. The device particularly distinguishes itself from long-term monitoring devices currently available by: 1) improving measured data quality by diminishing data variation caused by the user, technique or compliance issues; 2) converting, encrypting and identifying data for further transmission and processing of data; 3) incorporating a wireless transmission signal system (e.g. radio frequency, acoustic or optical) or other remote communication method to allow automatic transmission of data collected from the CCM / BIH assembly to either adjacent or remote CCM's or DCU's; 4) reducing biocompatibility issues associated with implantable sensors with the use of novel biomaterials and devices to decrease the adhesion or encapsulation of the biofluid access port by biological processes; and 5) coupling the wireless signal system to enable a two-way wireless-based control system to allow controlled or automatic delivery of compounds or devices from the CCM / BIH assembly.

[0012] In one aspect, the BIH assembly may comprise various types of sensing mechanisms, including thermal sensors (thermoresistors, thermocouples), electrical sensors (EKG, ECG, impedance, frequency or capacitance), optical sensors (photonic wavelength, calorimetric, turbidity), chemical sensors (pH, biomolecules, gases such as CO2, and other chemical sensors), enzyme-linked sensors (glucose oxidase, phosphatase, coupled substrates (e.g. horseradish peroxidase or alkaline phosphatase and other enzyme-linked sensors)), radiation sensors (gamma, beta and other radiation detectors), magnetic sensors (micro NMR circuitry and magnetic spin state) and physical sensors, such as flow meters and pressure sensors. Alternatively, the sensor may also comprise a MEMS (Micro Electrical Mechanical Systems) or a MOEMS (Micro Optical Electrical Mechanical Systems) sensing device, comprising at least one cantilever beam coated with polymeric compounds for detection of various physiological substances or conditions. The microcantilever beams allow increases in sensitivity and specificity, as compared to currently available technologies, and simplifies detection by coupling the beam to transducers which measure changes in capacitance, resonant frequency, or other techniques used in detecting mass changes in the spring element of the cantilever beam. In still other embodiments, nanotechnology devices may be incorporated into the sensor head or other components of the device for more accurate detection, cellular manipulation and measurement of physiological parameters. In one embodiment the BIH assembly, as well as other components of the system, may contain components micron, submicron or nanoscale in dimension, further lessening the obtrusiveness of the device to wearer.

[0013] In another aspect, the BIH assembly of the sensor element comprises materials that permit interaction of the sensor with the host environment. This includes microchannels, gel, fine mesh, screen, membrane, filters or a microporous frit, which permit interaction of sensors to the host environment while maintaining a segregated and sterile environment within the sensing element itself. This tends to extend the life of the sensor by preventing fouling of the biological sensor with macromolecules and other substances that can adhere onto the sensor mechanism.

[0014] In accordance with another aspect of the invention, the use of specialized biomedia can be incorporated into the sensing head device and may decrease the exposure of the sensor element to the external environment. This biomedia system may also decrease the adherence of the sensor element onto the host tissue or layer, a large component of the rejection mechanism of biological sensors. Moreover, the use of a biomedia system may lower trauma to the surrounding tissue or layer by providing medium that is physiologically compatible with the host, mimicking the tissue environment in which the sensor is implanted. In yet another aspect of the invention, growth factors, cell signaling and cell adhesion molecules will be integrated into the biomedia system, mimicking the tissue and further improving biocompatibility issues of the sensor implantation into the host species.

[0015] In other aspects, the biomedia may have gel-like properties at ambient room temperature, whereupon exposure to higher body temperatures changes the material to a fluid-like state and becomes less viscous. One utility of this gel-like material may be its use as part of a calibration process for the sensor elements. When the sensor is implanted on or into the host, the sensor itself is shielded from the host environment by the gel-like material. As the temperature around the sensor increases, the gel-like material changes viscosity, freeing calibration molecules from the matrix that then enter into the sensor. The sensor can then be accurately calibrated before being equilibrated into the host environment. The bio-media may also be used as a process or method during manufacturing. The bio-media may also provide increased product shelf-life storage by insulating the sensors on the BIH from degradation caused by ambient conditions such as temperature, humidity or other degenerative storage issues.

[0016] In another aspect of the invention, the BIH assembly, located on top or within the dermal layer, interacts with the CCM (Control and Communication Module) that is also located on top or within the dermal layer. The CCM interacts with the sensor unit either directly through a physical means (e.g. conductive wire, optical, acoustic or other means) or indirectly using a remote wireless-based signal and control system. The CCM also contains a power supply consisting of either a removable or responder power source. The CCM and the BIH assembly, if located on top of the dermal layer, are attached to the host patient through a bioadherence system, which allows minimal irritation of the outer body surface, thereby tending to decrease rejection and increase the longevity of the BIH and CCM assemblies.

Problems solved by technology

Long-term monitoring of physiological parameters has been particularly problematic to implement.

However, for individuals that lead an active life, very few options presently exist for long-term monitoring of physiological conditions.

Most devices only measure periodically and are prone to measurement variations caused by technique, compliance or use.

In addition, biocompatibility issues with many of these external devices are numerous, with side effects such as attendant skin irritations, increasing patient non-compliance with the monitoring devices.

Invasive devices can also introduce complications.

Although non-compliance and measurement variation issues may be decreased with semi-permanent implantable sensors, biocompatibility issues are even higher.

Implantable devices often have a shortened half-life, due to rejection of the device in the patient, accumulation of biological materials on the device themselves or other events, including infection and mechanical breakdown of the device.

Because the devices record only data that satisfies a set threshold parameter, it is unsuitable for establishing baseline patterns necessary in detecting low frequency events.

Although both devices combine the use of biological sensors with wireless transmission of data, it does not appear that they provide for a long-lasting, biologically compatible system that allows continuous feedback and analysis with a network-based system capable of relaying information from remote sensors on a mammalian subject to a central data analysis system.

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