INTRAOSSEOUS IMPLANTED BIOLOGICAL SENSOR

Abstract

A method and system for monitoring analytes in the circulatory system of an individual is provided. A biological sensor is implanted in the bone marrow of a patient and may be self contained within a housing. The biological sensor measures physiological parameters of a patient, including analytes, on a fixed or adjustable schedule. The biological sensor includes a control unit having a transmitter and an energy source for providing energy to the control unit. The biological sensor may be used to adjust other medical treatments and devices in a closed or semi closed loop mechanism and/or predict patient treatment.

Claims

1. A sensor for measuring analytes comprising: a housing having an interior; a housing control unit positioned within the housing and having a transmitter and a receiver; an energy source positioned within the housing for providing energy to the control unit; one or more sensing units positioned at least partially within the housing and extending from the housing into a bone marrow of a patient, the sensing units in communication with the control unit; a porous membrane covering a part of the housing that is configured to allow access to the interior of the housing.

2. The sensor of claim 1 further comprising an ancillary control unit located remotely from the sensor and in communication with the housing control unit, the ancillary control unit having a display.

3. The sensor of claim 2 wherein a signal from the one or more sensing units is received by the housing control unit and transmitted to the ancillary control unit.

4. The sensor of claim 3 wherein said signal transmitted to the ancillary control unit includes patient data that may be displayed on the display.

5. The sensor of claim 1 wherein the control unit is configured to receive a signal from the at least one or more sensing units, said signal including patient analyte data and transmit instructions to said at least one or more sensing units to measure analytes data on a fixed or adjustable schedule.

6. The sensor of claim 1 wherein the one or more sensing units are removable and replaceable.

7. The sensor of claim 1 further comprising a treatment system for providing medication to the patient, the treatment system housed within the housing or located remotely from a site where the sensor is implanted.

8. The sensor of claim 7 wherein the control unit is configured to receive a signal from the at least one or more sensing units, said signal including patient analyte data and transmit instructions to the treatment system to deliver medication to the patient based on the patient analyte data included in the at least one or more sensing units signal.

9. The sensor of claim 1 wherein the energy source is selected from one or more replaceable batteries or a self generating system which uses a process such as motion or vascular flow, body heat, or chemical reaction.

10. The sensor of claim 1 wherein the analytes are selected from biochemical, hormonal, inflammatory, hematologic, genetic/nucleic acid and physiologic concentrations, vascular pressures, flow rates, pharmacologic concentrations, degradation products, pH, oxygen, carbon dioxide, toxic exposures, metabolic factors such as glucose, lactate, electrolytes; hormones such as cortisol, insulin, epinephrine; drug and drug metabolites; other therapeutic substances such as monoclonal antibodies, ligands, and chemotherapeutic agents; hematologically active substances such coagulants and anticoagulants; DNA, RNA and nucleic acid containing substances.

11. The sensor of claim 1 wherein the sensor is implantable in a pelvic region of a patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] For a better understanding of the invention, and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which:

[0020] FIG. 1 is an illustration depicting a pelvis identifying a location site for implanting the sensor in accordance with the invention.

[0021] FIG. 2 is a schematic diagram of the sensor in accordance with the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0022] Referring to FIGS. 1 and 2 the intraosseous implantable biological sensor in accordance with the invention will now be described. The sensor 10 broadly includes a housing 12, one or more sensing units 14, a control unit 16 and an energy source 18. The housing 12 includes a membrane 20 thereon that allows replacement and/or replenishment of individual parts, such as sensing units 14. An ancillary processing device/control unit 22 can also be utilized and may integrated into the sensor or positioned and used at a remote location.

[0023] Sensor 10 may direct automated and semi automated treatment techniques such as closed, and partially closed loop infusions. The insertion into the marrow space allows measurement through small blood channels while allowing the sensor 10 to be fixed directly to tissue. In addition, the sensor 10 is embedded (implanted) so that the skin and subcutaneous tissues cover it allowing minimal external compromise.

[0024] Sensing units 14 may include optical, enzymatic, calorimetry, thermal, spectroscopy, or “lab on a chip.” A portion of the sensing units 14 are housed within the sensor housing and a portion thereof may project into the bone marrow 26 of a patient. Alternatively, the distal end of the sensing units may be flush with the housing 12 but housing may contain an opening 30 that exposes the sensing units to the bone marrow These may be in a combined modality and other non specified technologies may also be used. The device may measure one or more analytes over various time cycles. These may be fixed or controlled externally by a wireless method to adjust the timing of the sensor 10.

[0025] Control unit 16 may include a receiver for receiving a signal from the sensing units that includes physiological data of the patient. The control unit 16 may also includes a transmitter that may transmit the signal to a remotely located ancillary processing device 22 for analysis. The processing device 22 may include a display screen for displaying the analyzed data to monitor the condition of the patient. Data generated from the sensing units 14 may alter treatment settings of respirators, dialysis systems, pacemakers, defibrillators and intravenous, intraarterial, interstitial, cerebrospinal and subcutaneous injections and infusions as well as alteration and adjustment of other medical devices or treatments. Control unit 16 may include memory having a data base of knowledge including known normative data related to interpreting the analyte data received from the sensing units. Control unit 16 receives a signal from the sensing units which contains patient physiological parameters and analyzes the physiological parameters and other data obtained from the sensing units 14. Control unit 16 analyzes the data (i) in isolation as it is received; (ii) in the context of measurement and analysis based on the past history of the patient, which is stored in memory; or (iii) cross-references the patient data in the signal and cross-references it with the known normative data in the database. Alternatively, control unit 16 transmit the signal to a remotely located ancillary processing/control unit 22. The processing unit 22 optionally includes a display device 24 for displaying the output. The control unit 16 or the ancillary processing unit 22 can also include information related to goal-directed therapies associated with particular disease states for providing suggested goal-directed treatments based on the cross-referencing step and outputs a suggested treatment by transmitting it wirelessly or by wire to a treatment system 28. The treatment system 28 may include one or more medications for delivering the medications to a patient.

[0026] In addition the sensing units 14 could monitor potentially toxic substances such as inhalants or injurious materials allowing rapid treatment, for example antidotes. Such treatment could be integrated with a separate embedded structure and could be initiated by a signal from the sensor. This treatment component could be embedded in the marrow 26 or another part of the body.

[0027] Energy source 18 may include one or more replaceable batteries or a self generating system which uses a process such as motion or vascular flow, body heat, or chemical reaction. These in combination with other sources known to those of skill in the art may also be used.

[0028] The sensor 10 is configured to measure and record numerous analytes including but not limited to biochemical, hormonal, inflammatory, hematologic, genetic/nucleic acid and physiologic concentrations, vascular pressures, flow rates, pharmacologic concentrations, degradation products, pH, oxygen, carbon dioxide, toxic exposures, metabolic factors such as glucose, lactate, electrolytes; hormones such as cortisol, insulin, epinephrine; drug and drug metabolites; other therapeutic substances such as monoclonal antibodies, ligands, and chemotherapeutic agents; hematologically active substances such coagulants and anticoagulants; DNA, RNA and nucleic acid containing substances.

[0029] The sensor 10 may be implanted by surgical insertion and remain without extension through the skin. The area of implantation is pelvic and usually the ileum but not restricted to these sites. The housing 12 may comprise biologically inert or biocompatible material such as polymers, stainless steel, silicone and the like. The housing membrane 20 is porous so as to allow contact with the marrow circulation without producing inflammation and/or rejection. Regeneration of the sensing units 14 could be through injection or insertion of new material through temporary use of a catheter or needle into the device or alternatively extraction of the sensing units and replacement such as in a self contained form. Those of skill in the art will also appreciate that although long-term use is contemplated the entire sensor may be replaced or individual parts such as the energy source 18 or control unit 16 may be replaced or replenished.

[0030] While the invention has been described with reference to the specific embodiments thereof, those skilled in the art will be able to make various modifications to the described embodiments of the invention without departing from the true spirit and scope of the invention. The terms and descriptions used herein are set forth by way of illustration only and are not meant as limitations. Those skilled in the art will recognize that these and other variations are possible within the spirit and scope of the invention as defined in the following claims and their equivalents.