Gateway platform for biological monitoring and delivery of therapeutic compounds

• US 7,044,911 B2
• Filed: 10/29/2001
• Issued: 05/16/2006
• Est. Priority Date: 06/29/2001
• Status: Expired due to Fees

• Current Assignee: PhiloMetron Inc.
• Original Assignee: PhiloMetron Inc.
• Inventors: Edman, Carl F., Merz, Diethard, Drinan, Darrel
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Astorino, Michael C.
• Application Number:
  US10/032,765
• Publication Number:
  US 20030004403A1
• Time in Patent Office: 1,660 Days
• Field of Search: 600300-301, 600/345, 600/347, 600/361, 600/365, 128903-905, 128/920, 705/2, 705/3, 604/174, 604/175, 604/290, 604 65- 68, 607 28- 32, 607 58- 60
• US Class Current: 600/300
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10S 128/904 : Telephone telemetry

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.

Claims

1. A system for monitoring physiological status of a mammalian subject, comprising:

a. one or more biointerface heads (BIH), each comprising one or both of a sensor for measuring a physiological parameter and a device for therapeutic compound delivery, at least one of said biointerface heads being implanted subdermally and configured to communicate data and a BIH identifier;

b. at least one control and communication module (CCM) attached to an external surface of said subject and storing a CCM identifier and which is linked to at least one biointerface head to receive said data and said BIH identifier, wherein said control and communication module processes data from at least one biointerface head;

c. at least one data collection unit (DCU) which receives data and said identifiers from the control and communication module; and

d. a remote database management system which receives data from the at least one data collection unit and processes said data.

2. The system of claim 1, wherein said biointerface head is attached to said mammalian subject with at least one adhesive.

3. The system of claim 2, wherein said adhesive contains one or more of the groups comprising:

growth factors, adherence molecules, adherence attractants or factors which promote cutaneous wound-healing mechanisms and formation of an epithelial-like structure around a portion of said system.

4. The system of claim 1, wherein said system comprises a transdermal conduit and a biofluid access port, and wherein the transdermal conduit and biofluid access port are coated with a hydrogel material.

5. The system of claims 4, wherein the hycirogel material contains preservatives, anti-inflammatory agents, antibiotics or antimicrobial agents.

6. The system of claims 4, wherein the hydrogel material contains a chemical, compound or molecule for calibration of the sensor.

7. The system of claim 4, wherein the transdermal conduit comprises a fluid material containing preservatives, anti-inflammatory agents, antibiotics or antimicrobial agents.

8. The system of claim 1, wherein said system comprises a chamber which releases one or more therapeutic agents.

9. A system comprising:

a subdermal physiological parameter sensor to measure a physiological parameter of a mammalian subject and to generate measurement information based on the measurements;

a mounting structure that anchors said system to a dermal layer;

a flexible transdermal conduit attached to said mounting structure at or near a first end, wherein said transdermal conduit is in contact with a sensor assembly;

a sensor mounting head, wherein said sensor mounting head is attached to a second end of said transdermal conduit;

a biofluid access port within said sensor mounting head, the biofluid access port further comprising microstructures allowing biofluid flow into the transdermal conduit to contact the sensor assembly and block transmission of external pathogens into a subject;

a control and communication module in data communication with the physiological parameter sensor to receive the measurement information from the physiological parameter sensor, the control and communication module including signal processing circuitry to generate and transmit a first signal based on the measurement information.

10. The system of claim 9, wherein the control and communication module further comprises signal encryption circuitry to encrypt the first signal for transmission.

11. The system of claim 9, wherein said mounting structure is attached to said mammalian subject with at least one adhesive.

12. The system of claim 11, wherein said adhesive contains one or more of the groups comprising:

growth factors, adherence molecules, adherence attractants or factors which promote cutaneous wound-healing mechanisms and formation of an epithelial-like structure around the mounting structure.