Apparatus for detecting at least one predetermined condition and providing an informational signal in response thereto in a medication infusion system

• US 4,619,653 A
• Filed: 11/04/1982
• Issued: 10/28/1986
• Est. Priority Date: 04/27/1979
• Status: Expired due to Term

• Current Assignee: Johns Hopkins University of Baltimore Maryland
• Original Assignee: Johns Hopkins University
• Inventors: Fischell, Robert E.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Jaworski, Francis J.
• Application Number:
  US06/439,139
• Time in Patent Office: 1,454 Days
• Field of Search: 128/DIG. 12, 128/ DIG. 13, 604/890-891, 604/65-67, 604/49, 604/131, 604/151-153
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

A medication infusion system provides redundant safety and includes condition detecting and informational alarm signal generating apparatus for indicating if (1) a fluid leak occurs in different portions of the system; (2) a programmable input from a patient or physician would result in exceeding a safe dosage limit; (3) the reservoir containing medication has been filled; (4) the intended medication pumping does not correlate with the pumping actually effected; (5) battery voltage is low; (6) the medication reserve is low; and (7) the system has been switched off. The apparatus may provide subcutaneous electrical, thermal, or audible stimulation to the patient and also provides a signal which a physician may monitor. The stimulation may be coded to separately identify each above-listed deviation in nominal system performance. In addition, the number of medication requests are correlated with actual medication dispensing to assure proper operation. An identification scheme is provided which matches the patient with his or her corresponding medication.

Claims

1. An infusion system for providing medication to a living body of a patient comprising:

an infusion apparatus for implantation in said living body, including,

a medication reservoir for storing selected medication;

a pump means for infusing a fixed dosage of said medication into said living body with each pump actuation;

an infusion output from which doses of medication exit the infusion apparatus and are dispensed to the patient;

a control means for applying an electrical pulse to the pump means to delivery said fixed dosage of medication;

a means for detecting the presence of at least one predetermined condition regarding the operational state of the infusion apparatus, wherein said detecting means comprises a condition sensor, disposed at the infusion output, for sensing the dispensing of a dose of medication, and, a comparing means for detecting when the number of medication dosages detected by said condition sensor deviates from the number of applied electrical pulses generated by said control means; and

,

a means, operably coupled to said detecting means, for alerting said patient when said at least one predetermined condition is detected.

4. The apparatus of claim 1 or 2, wherein said alerting means comprises:

an acoustic transducer; and

,

a means, responsive to said detecting means, for activating said acoustical transducer to generate an acoustical signal when said at least one predetermined condition is detected.

5. The apparatus of claim 1 or 2, wherein said alerting means comprises:

a tickle means for applying a subcutaneous electrical tickle to an intracorporeal location; and

,

a means, responsive to said detecting means, for activating said tickle means to generate an electrical tickle when said at least one predetermined condition is detected.

2. An infusion system for providing medication to a living body of a patient comprising:

an infusion apparatus for implantation in said living body, including,

a medication reservoir for storing selected medication;

a means for maintaining the pressure in the medication reservoir below a predetermined level that is less than ambient body pressure;

a means for detecting the presence of at least one predetermined condition regarding the operational state of the infusion apparatus, wherein said detecting means comprises a condition sensor for detecting when the fluid level in the reservoir exceeds a predetermined fill level higher than a normal full level, indicating that body fluids have leaked into the infusion apparatus; and

,

a means, operably coupled to said detecting means, for alerting said patient when said at least one predetermined condition is detected.

3. The apparatus as in claim 2, wherein said detecting means further includes a second condition sensor for detecting when the pressure in the medication reservoir exceeds a predetermined pressure level.

6. An infusion system for providing medication to a living body of a patient comprising:

an infusion apparatus for implantation in said living body, including,

a medication reservoir for storing selected medication;

a means for detecting the presence of at least one predetermined condition regarding the operational state of the infusion apparatus;

a tickle means for applying a subcutaneous electrical tickle to an intracorporeal location; and

,

a patient alerting means, responsive to said detecting means, for activating said tickle means to generate an electrical tickle when said at least one predetermined conditions is detected, wherein said infusion system contains an extracorporeal transmitter for sending a command signal to set the intensity of said electrical tickle and wherein said infusion apparatus further includes a receiver means operably coupled to said patient alerting means for detecting said command signal and wherein said patient alerting means includes a means for setting the intensity of said electrical tickle in response to said received command signal.

7. An infusion system for providing medication to a living body of a patient comprising:

an infusion apparatus for implantation in said living body, including,

a medication reservoir for storing selected medication;

a means for detecting the presence of at least one predetermined condition regarding the operational state of the infusion apparatus;

an acoustical transducer;

a patient alerting means, responsive to said detecting means, for activating said acoustical transducer to generate an acoustical signal when said at least one predetermined condition is detected, wherein said infusion system contains an extracorporeal transmitter for sending a command signal to set the intensity of said acoustical signal and wherein said infusion apparatus further includes a receiver means operably coupled to said patient alerting means for detecting said command signal and wherein said patient alerting means includes a means for setting the intensity of said acoustical signal in response to said received command signal.

8. An infusion apparatus for implantation into a living body of a patient comprising:

a housing;

a medication reservoir for storing selected medication, said medication reservoir located in said housing;

a pump means for infusing a fixed dosage of said medication into said living body with each pump actuation;

an infusion output coupled to said pump means from which dosages of medication exit the infusion apparatus and are dispensed into the patient;

a control means for applying electrical pulses to said pump means, each electrical pulse actuating said pump means to deliver said fixed dosage of medication;

a power supply;

a means associated with said medication reservoir for maintaining the pressure in said medication reservoir below a predetermined level that is less than ambient pressure;

a means for monitoring at least two predetermined conditions regarding the operational state of the infusion apparatus, said at least two conditions selected from the following group of conditions;

a. medication level in said medication reservoir is at a preselected low level,

b. presence of medication or body fluids between the medication reservoir and the housing,

c. a difference between the number of electrical pulses provided by said control means to said pump means and the number of fixed dosages of medication delivered by said pump means through said infusion output;

d. medication level in said medication reservoir exceeds a predetermined fill level higher than a normal full level, indicating that body fluids have leaked into the infusion apparatus,

e. pressure in the medication reservoir exceeds a predetermined negative pressure level, and

f. power supply output falls below a preset level,

an acoustical transducer; and

,

a patient alerting means, responsive to said monitoring means for activating said acoustical transducer to generate an acoustical signal when at least one of said predetermined condition is detected.

9. An infustion apparatus for implantation into a living body of a patient comprising:

a housing;

a medication reservoir for storing selected medication, said medication reservoir located in said housing;

a pump means for infusing a fixed dosage of said medication into said living body with each pump actuation;

an infusion output coupled to said pump means from which dosages of medication exit the infusion apparatus and are dispensed into the patient;

a control means for applying electrical pulses to said pump means, each electrical pulse actuating said pump means to deliver said fixed dosage of medication;

a power supply;

a means associated with said medication reservoir for maintaining the pressure in said medication reservoir below a predetermined level that is less than ambient pressure;

a means for monitoring at least two predetermined conditions regarding the operational state of the infusion apparatus, said at least two conditions selected from the following group of conditions;

a. medication level in said medication reservoir is at a preselected low level,

b. presence of medication or body fluids between the medication reservoir and the housing,

c. a difference between the number of electrical pulses provided by said control means to said pump means and the number of fixed dosages of medication delivered by said pump means through said infusion output;

d. medication level in said medication reservoir exceeds a predetermined fill level higher than a normal full level, indicating that body fluids have leaked into the infusion apparatus,

e. pressure in the medication reservoir exceeds a predetermined negative pressure level, and

f. power supply output falls below a preset level,

a tickle means for applying a subcutaneous electrical tickle to an intracorporeal location; and

,

a patient alerting means, responsive to said monitoring means, for activating said tickle means to generate an electrical tickle when at least one of said predetermined conditions is detected.