Sensing, interrogating, storing, telemetering and responding medical implants

• US 6,802,811 B1
• Filed: 09/15/2000
• Issued: 10/12/2004
• Est. Priority Date: 09/17/1999
• Status: Expired due to Fees

• Current Assignee: Endoluminal Therapeutics Incorporated
• Original Assignee: Endoluminal Therapeutics Incorporated
• Inventors: Slepian, Marvin J.
• Primary Examiner(s): Jones, Mary Beth
• Assistant Examiner(s): KREMER, MATTHEW J
• Application Number:
  US09/662,927
• Time in Patent Office: 1,488 Days
• Field of Search: 600/309-311, 600/325, 600/327, 600/339, 600/300, 600/332, 604/890.1, 604/891.1, 604/65-67
• US Class Current: 600/309
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH

Abstract

Implants and implants, including sensors responsive to pressure, fluid flow, concentration of analytes, pH and other variables, including a feedback loop and means for modifying the implant after placement in a patient in response to measurements made using the sensors, have been developed. These are particularly useful in cardiology, where the implants contain one or more sensors responsive to variables which change over time, for example, pressure which is indicative of changes in fluid flow and diameter of the vessel in which the implant has been placed. Feedback from the sensor(s) either directly, or indirectly via monitoring means external to the patient, signal changes that may be required, such as expansion of the implant in the case where the vessel diameter changes over time or the implant becomes unstable or migrates. In another embodiment, the implant contains a bioactive, prophylactic, diagnostic or pH modifying agent wherein the implant is formed of a temperature or pH responsive material so that the agent is released when the temperature or pH is altered. These systems can also be used to connect a patient to a remote data storage system, such as the internet or a computer accessible through devices such as PDA (Palm Pilot systems), phone system devices (portable phones, answering services, beepers, office fax machines), that the physician or nurse can monitor or use to interact remotely with the implant.

Claims

1. A system for monitoring and responding to the environment of an implanted device comprising:

one or more sensors configured for monitoring data relating to variables selected from the group consisting of electrical, magnetic, mechanical, fluid flow, chemical, and thermal properties in the device or its environment in a patient,

at least one actuator configured for implementing a response to the monitored data in the device by causing a configurational change in the device; and

means for communication selected from the group consisting of a means for communication to one of a series of nested loops of information exchange, monitoring means configured for positioning external to the patient, an external input connected through loops to effectuate change in the device from the at least one actuator, transmitting and receiving means to the one or more sensors and means for remotely accessing the data;

wherein the one or more sensors directly interact with the device through the at least one actuator such that data transmitted from the one or more sensors to the at least one actuator causes a configurational change in the device.

2. The system of claim 1 which includes a data storage means.

3. The system of claim 2 wherein the data storage means is configured to be placeable on the device or contiguous to the device or within or on the body of the patient.

4. The system of claim 1 which includes a telemetry means.

5. The system of claim 4 wherein the telemetry means is an analog or digital electronic device.

6. The system of claim 1 comprising means for communication to one of a series of nested loops of information exchange.

7. The system of claim 1 comprising an external input connected through loops to effectuate change in the device from the at least one actuator.

8. The system of claim 1 additionally comprising monitoring means configured for positioning external to the patient.

9. The system of claim 1 wherein the sensor is configured to detect changes in pH, temperature, ion concentration, or analyte concentration.

10. The system of claim 1 comprising transmitting and receiving means to the one or more sensors.

11. The system of claim 1 comprising means for remotely accessing the data.

12. The system of claim 1 wherein at least one sensor is connected to means for transmitting or receiving data from a computer or phone communication means.

13. A system for monitoring and responding to the environment of an implanted device comprising

one or more sensors configured for monitoring data relating to variables selected from the group consisting of electrical, magnetic, mechanical, fluid flow, chemical, and thermal properties in the device or its environment in a patient, and

at least one actuator configured for implementing a response to the monitored data in the device by causing a configurational change in the device;

wherein the one or more sensors directly interact with the device through the at least one actuator such that data transmitted from the one or more sensors to the at least one actuator causes a configurational change in the device wherein at least one sensor is configured to measure fouling of the device or at least one sensor over time.

14. The system of claim 13 wherein at least one sensor is configured to measure protein deposition or formation of a bacterial film on a biliary stent, increase in calcification of a urinary stent, and neointimal thickening of an arterial stent, resulting in an increase in thickness, mass and wall shear.

15. A system for monitoring and responding to the environment of an implanted device comprising:

one or more sensors configured for monitoring data relating to variables selected from the group consisting of electrical, magnetic, mechanical, fluid flow, chemical, and thermal properties in the device or its environment in a patient, and

at least one actuator configured for implementing a response to the monitored data in the device by causing a configurational change in the device;

wherein the one or more sensors directly interact with the device through the at least one actuator such that data transmitted from the one or more sensors to the at least one actuator causes a configurational change in the device comprising;

(a) one or more sensors for monitoring the general environment of the implanted device;

(b) monitoring means; and

(c) the one or more sensors configured for communicating information to the monitoring means and to each other, and configured for communicating commands to the actuator.

16. The system of claim 15 wherein the one or more sensors communicate information to a computer transmitting the information to another computer via the internet.

17. The system of claim 16 wherein the transmission over the Internet to another computer is via a posting to the world wide web.

18. An implantable device comprising:

one or more sensors configured for monitoring at least one condition;

at least one actuator configured for implementing a response to the monitored condition in the device by causing a configurational change in the device; and

means for communication to one of a series of nested loops of information exchange;

wherein the one or more sensors directly interact with the device through the at least one actuator such that data transmitted from the one or more sensors to the at least one actuator causes a configurational change in the device; and

the one or more sensors and the at least one actuator are configured for control by at least one apparatus external to the implantable device.