CA2505639A1 - System and method for initiating and maintaining continuous, long-term control of a concentration of a substance in a patient using a feedback or model-based controller coupled to a single-needle or multi-needle intradermal (id) delivery device - Google Patents

System and method for initiating and maintaining continuous, long-term control of a concentration of a substance in a patient using a feedback or model-based controller coupled to a single-needle or multi-needle intradermal (id) delivery device Download PDF

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Publication number
CA2505639A1
CA2505639A1 CA002505639A CA2505639A CA2505639A1 CA 2505639 A1 CA2505639 A1 CA 2505639A1 CA 002505639 A CA002505639 A CA 002505639A CA 2505639 A CA2505639 A CA 2505639A CA 2505639 A1 CA2505639 A1 CA 2505639A1
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CA
Canada
Prior art keywords
concentration
patient
substance
controller
insulin
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002505639A
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French (fr)
Other versions
CA2505639C (en
Inventor
Steven Keith
Ronald Pettis
Noel Harvey
John D. Denuzzio
Robert S. Parker
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Becton Dickinson and Co
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Individual
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Family has litigation
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Application filed by Individual filed Critical Individual
Publication of CA2505639A1 publication Critical patent/CA2505639A1/en
Application granted granted Critical
Publication of CA2505639C publication Critical patent/CA2505639C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/201—Glucose concentration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic

Abstract

A closed loop therapy system (200) for controlling a concentration of a substance, such as blood glucose concentration, in the body of a user. The system and method employ a sensor system (206) that measures a glucose level in the bod y, a controller (202) that uses the measured glucose levels to generate an output that can be used to automatically or manually control an intradermal insulin infusion system (204) to set a constant or time-varying profile of target blood glucose concentrations in a user, and then infuse ann appropriate amount of insulin into the body o f the user so as to reach and maintain the target values of the blood glucose concentratio n.

Claims (51)

1. ~A system for controlling the concentration of a substance in a patient, the system comprising:
a delivery device, adapted to deliver a material to the patient intradermally to result in at least one of rapid uptake of said material and rapid clearance of said material; and~
a controller, adapted to determine the concentration of said substance in the patient that occurs in response to said material delivered to the patient, and to provide an output that is adaptable for use to control the delivery device to control an amount of said material delivered to the patient based on the concentration of said substance.
2. ~The system of claim 1, wherein:
said controller is adapted to provide said output to said delivery device to automatically control the delivery device.
3. ~The system of claim 1, wherein:
said controller provides said output as information relating to the concentration of said substance which is readable for use in manual adjustment of said delivery device to infuse the appropriate amount of material into the patient.
4. ~The system of claim 1, wherein:
said material includes insulin and said substance includes glucose.
5. ~The system of claim 4, wherein;
said insulin includes short-acting insulin.
6. ~The system of claim 1, wherein:
said material and said substance are the same.
7. ~The system of claim 1, wherein:
said delivery device comprises a single-needle array or a multi-needle array, adapted to deliver said material to the patient intradermally.
8, ~The system of claim 1, further comprising:
a sensor, adapted to detect said concentration of said substance in the patient~
and to provide a signal indicative thereof to said controller, which is adapted to analyze said signal to determine the concentration of said substance in the patient.
9. ~The system of claim 8, wherein:
said sensor is adapted to detect said concentration of said substance at a location in said patient, and said controller is adapted to analyze said signal to estimate said concentration of said substance at another location in the patient different from said location at which said sensor detected said concentration.
10. ~The system of claim 1, further comprising:
a self-contained power source adapted to power said system.
11. ~The system of claim 1, further comprising:
an insulin storage device, adapted to store insulin as said material for delivery to said patient.
12. ~The system of claim 1, wherein said system is portable and wearable by the patient.
13. ~The system of claim 1, wherein at least a portion of communications between said controller and said delivery device includes wireless communications.
14. ~The system of claim 8, wherein at least a portion of communications between said controller, said sensor and said delivery device includes wireless communications.
15. ~The system of claim 1, wherein said controller is adapted to communicate with a device outside of the system to relay information between the controller and at least one of the patient and a health care provider.
16. ~The system of claim 1, wherein said controller employs a control model that includes a physiologically based model.
17. ~The system of claim 1, wherein said controller employs a control model that includes a data based empirical model.
18. ~The system of claim 1, wherein:
said material includes insulin and said substance includes glucose; and said controller employs an algorithm to compare a pre-delivery concentration of said glucose present prior to said delivery of said insulin to a target or predicted glucose concentration, to compare a post-delivery concentration of said glucose present after said delivery of said insulin to a target or predicted glucose concentration, and to determine an appropriate insulin dose based on these comparisons.
19. ~The system of claim 18,wherein:
said controller employs a control model that includes a physiologically based model, and said controller adjusts said model based on the comparison of said post-delivery glucose concentration and said target or predicted glucose concentration.
20. ~The system of claim 18, wherein:

said controller employs a control model that includes a data based (empirical) model, and said controller adjusts said model based on the comparison of said post-delivery glucose concentration and said target or predicted glucose concentration.
21. ~The system of claim 1, wherein:
said rapid uptake is influenced by a PK/PD (pharmacokinetics and pharmacodynamics) effect on said material.
22. ~A method for controlling the concentration of a substance in a patient, the method comprising:
delivering a material to the patient intradermally to result in at lease one of rapid uptake of said material and rapid clearance of said material; and determining the concentration of said substance in the patient that occurs in response to said material delivered to the patient and providing an output that is adaptable for use to control an amount of said material delivered to the patient based on the concentration of said substance.
23. The method of claim 22, wherein:
said providing provides said output to a delivery device to automatically control the delivery device to control said amount of said material delivered to the patient.
24. The method of claim 22, wherein:
said providing provides said output as information relating to the concentration of said substance which is readable for use in manual adjustment of a delivery device to infuse the appropriate amount of said material into the patient.
25. The method of claim 22, wherein:
said material includes insulin and said substance includes glucose.
26. The method of claim 25, wherein:
said insulin includes short-acting insulin.
27. The method of claim 22, wherein:
said material and said substance are the same.
28. The method of claim 22, wherein:
said delivering step includes operating a delivery device comprising a single-needle or a multi-needle array to deliver said material to the patient intradermally.
29. The method of claim 22, further comprising:
sensing said concentration of said substance in the patient and to provide a signal indicative thereof which is used in said determining step to analyze said signal to determine the concentration of said substance in the patient.
30. The method of claim 29, wherein:
said sensing senses said concentration of said substance at a location in said patient, and said determining analyzes said signal to estimate said concentration of said substance at another location in the patient different from said location at which said sensing detected said concentration.
31. The method of claim 22, further comprising:
providing power to a system that is adapted to perform said delivering, determining and providing steps using a self-contained power source.
32. The method of claim 22, further comprising:
storing insulin as said material for delivery to said patient.
33. The method of claim 22, wherein:

said delivering, determining and providing steps are performed by a system that is portable and wearable by the patient.
34. The method of claim 22, further comprising:
communicating wirelessly between a delivery device that performs said delivering step and a controller that performs said determining and providing steps.
35. The method of claim 22, further comprising:
communicating wirelessly between a delivery device that performs said delivering step, a controller that performs said determining and providing steps and a sensor that performs said sensing step.
36. The method of claim 22, further comprising:
communicating with a device outside of the system that performs said delivering, determining and providing steps to relay information between the system and at least one of the patient and a health care provider.
37. The method of claim 22, wherein said determining step employs a control model that includes a physiologically based model.
38. The method of claim 22, wherein:
said material includes insulin and said substance includes glucose; and said determining step employs an algorithm to compare a pre-delivery concentration of said glucose present prior to said delivery of said insulin to a target or predicted glucose concentration, to compare a post-delivery concentration of said glucose present after said delivery of said insulin to a target or predicted glucose concentration, and to determine an appropriate insulin dose based on these comparisons.
39. The method of claim 38, wherein:

said determining step employs a control model that includes a physiologically based model, and said controller adjusts said model based on the comparison of said post-delivery glucose concentration and said target or predicted glucose concentration.
40. The method of claim 38, wherein:
said determining step employs a control model that includes a data based (empirical) model, and said controller adjusts said model based on the comparison of said post-delivery glucose concentration and said target or predicted glucose concentration.
41. The method of claim 22, wherein:
said rapid uptake is influenced by a PK/PD (pharmacokinetics and pharmacodynamics) effect on said material.
42. A system for adjusting the concentration of a substance in a patient, the system comprising:
a controller, adapted to provide information representing a profile of target concentrations; and a delivery device, adapted to deliver a material to the patient intradermally under the control of the controller to adjust the concentration of the substance to the target concentration substantially in accordance with the profile.
43. A system as claimed in claim 42, wherein:
the substance is blood glucose and the material includes insulin.
44. A system as claimed in claim 42, wherein:
the profile includes a plurality of target concentrations over time.
45. A system as claimed in claim 42, wherein:

the profile is representable as a line having a non-zero slope.
46. A system as claimed in claim 42, wherein:
the delivery device includes a single-needle or a multi-needle array.
47. A method for adjusting the concentration of a substance in a patient, the method comprising:
providing information representing a profile of target concentrations; and delivering a material to the patient intradermally under the control of the controller to adjust the concentration of the substance to the target concentration substantially in accordance with the profile.
48. A method as claimed in claim 47, wherein:
the substance is blood glucose and the material includes insulin.
49. A method as claimed in claim 47, wherein:
the profile includes a plurality of target concentrations over time.
50. A method as claimed in claim 47, wherein:
the profile is representable as a line having a non-zero slope.
51. A method as claimed in claim 47, wherein:
the delivering step includes using a delivery device having a single-needle or a multi-needle array to deliver the material.
CA2505639A 2002-10-11 2003-10-14 System and method for initiating and maintaining continuous, long-term control of a concentration of a substance in a patient using a feedback or model-based controller coupled to a single-needle or multi-needle intradermal (id) delivery device Expired - Fee Related CA2505639C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US41755902P 2002-10-11 2002-10-11
US60/417,559 2002-10-11
US43223302P 2002-12-11 2002-12-11
US60/432,233 2002-12-11
PCT/US2003/032506 WO2005061041A1 (en) 2002-10-11 2003-10-14 Insulin delivery system with sensor

Publications (2)

Publication Number Publication Date
CA2505639A1 true CA2505639A1 (en) 2004-04-11
CA2505639C CA2505639C (en) 2012-07-03

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ID=34713510

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CA2505639A Expired - Fee Related CA2505639C (en) 2002-10-11 2003-10-14 System and method for initiating and maintaining continuous, long-term control of a concentration of a substance in a patient using a feedback or model-based controller coupled to a single-needle or multi-needle intradermal (id) delivery device

Country Status (12)

Country Link
US (1) US7060059B2 (en)
EP (1) EP1575656B1 (en)
JP (1) JP4599296B2 (en)
KR (1) KR101226540B1 (en)
CN (1) CN1859943B (en)
AT (1) ATE433775T1 (en)
AU (1) AU2003287073B2 (en)
CA (1) CA2505639C (en)
DE (1) DE60328039D1 (en)
DK (1) DK1575656T3 (en)
ES (1) ES2328806T3 (en)
WO (1) WO2005061041A1 (en)

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