CA2421133A1 - Devices, systems and methods for patient infusion - Google Patents

Devices, systems and methods for patient infusion Download PDF

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Publication number
CA2421133A1
CA2421133A1 CA002421133A CA2421133A CA2421133A1 CA 2421133 A1 CA2421133 A1 CA 2421133A1 CA 002421133 A CA002421133 A CA 002421133A CA 2421133 A CA2421133 A CA 2421133A CA 2421133 A1 CA2421133 A1 CA 2421133A1
Authority
CA
Canada
Prior art keywords
flow
local processor
fluid
exit port
port assembly
Prior art date
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
CA002421133A
Other languages
French (fr)
Other versions
CA2421133C (en
Inventor
J. Christopher Flaherty
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Insulet Corp
Original Assignee
Insulet Corporation
J. Christopher Flaherty
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=22869381&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2421133(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Insulet Corporation, J. Christopher Flaherty filed Critical Insulet Corporation
Priority to CA2771723A priority Critical patent/CA2771723C/en
Publication of CA2421133A1 publication Critical patent/CA2421133A1/en
Application granted granted Critical
Publication of CA2421133C publication Critical patent/CA2421133C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • 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
    • 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
    • A61M2005/1401—Functional features
    • A61M2005/1403—Flushing or purging
    • 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
    • A61M2005/1401—Functional features
    • A61M2005/1405—Patient controlled analgesia [PCA]
    • 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
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3569—Range sublocal, e.g. between console and disposable
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems
    • A61M2205/6072—Bar codes
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/01—Remote controllers for specific apparatus
    • 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • 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
    • A61M5/16804—Flow controllers
    • A61M5/16809—Flow controllers by repeated filling and emptying of an intermediate volume
    • 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
    • A61M5/16804—Flow controllers
    • A61M5/16813—Flow controllers by controlling the degree of opening of the flow line

Abstract

A device (10) for delivering a fluid to a patient, including an exit port (70), a dispenser (40) for causing fluid from a reservoir to flow to the exi t port, a local processor (50) programmed to cause a flow of fluid to the exit port based on flow instructions from a separate, remote control device, and a wireless receiver (60) connected to the local processor for receiving the fl ow instructions. The device also inlcudes a housing free of user input componen ts for providing flow instructions to the local proessor, in order to reduce th e complexity and costs of the device so that the device lends itself to being disposable in nature. A system and a kit are also described that include the fluid delivery device, a separate, remote control device, and accessories fo r transcutaneous delivery of fluid medications. Methods of utilizing the fluid delivery device to infuse fluid medications are additionally disclosed.</SDO AB>

Claims (51)

  1. What is claimed is:

    A device for delivering fluid to a patient, comprising:
    an exit port assembly adapted to connect to a transcutaneous patient access tool;
    a dispenser for causing fluid from a reservoir to flow to the exit port assembly;
    a local processor connected to the dispenser and programmed to cause a flow of fluid to the exit port assembly based on flow instructions;
    a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and a housing containing the exit port assembly, the dispenser, the local processor, and the wireless receiver;
    wherein the housing is free of user input components for providing flow instructions to the local processor.
  2. 2. A device according to Claim 1, wherein the flow instructions cause a predetermined rate of fluid flow for a predetermined period.
  3. 3. A device according to Claim 2, wherein the predetermined rate of fluid flow comprises a basal rate.
  4. 4. A device according to Claim 1, wherein the flow instructions cause a predetermined volume of fluid to flow for a predetermined period.
  5. 5. A device according to Claim 4, wherein the predetermined volume comprises a bolus volume.
  6. 6. A device according to Claim 1, wherein the local processor is programmed to cause a flow of fluid comprising pulse volumes.
  7. 7. A device according to Claim 1, further comprising at least one user interface component accessible from an exterior of the housing for occluding flow to the exit port assembly.
  8. 8. A device according to Claim 1, further comprising a power supply for supplying electrical power to the local processor.
  9. 9. A device according to Claim 8, wherein the power supply is integrated with the device.
  10. 10. A device according to Claim 8, wherein the power supply comprises a replaceable battery.
  11. 11. A device according to Claim 1, wherein the receiver utilizes radio frequency signals.
  12. 12. A device according to Claim 1, further comprising a transmitter connected to the local processor for transmitting information from the local processor to a separate, remote control device.
  13. 13. A device according to Claim 12, wherein the housing is free of user output components for providing information from the local processor.
  14. 14. A device according to Claim 1, wherein the exit port assembly includes a Luer connector.
  15. 15. A device according to Claim 1, further comprising a transcutaneous patient access tool connected to the exit port assembly.
  16. 16. A device according to Claim 15, wherein the transcutaneous patient access tool comprises a tubular member.
  17. 17. A device according to Claim 16, wherein the tubular member is adapted for residing in subcutaneous tissue of a patient.
  18. 18. A device according to Claim 17, wherein the tubular member comprises a rigid needle.
  19. 19. A device according to Claim 15, wherein the transcutaneous patient access tool comprises micropenetrators.
  20. 20. A device according to Claim 1, further comprising a reservoir, and the dispenser controls fluid flow from the reservoir to the exit port assembly.
  21. 21. A device according to Claim 20, wherein the reservoir contains a therapeutic fluid.
  22. 22. A device according to Claim 20, further comprising a fill port connected to the reservoir.
  23. 23. A device according to Claim 20, wherein the reservoir is made of a flexible material and collapses as emptied.
  24. 24. A device according to Claim 20, wherein the reservoir is thermally insulated.
  25. 25. A device according to Claim 20, wherein the reservoir is pressurized.
  26. 26. A device according to Claim 25, further comprising a spring compressing the reservoir.
  27. 27. A device according to Claim 20, further comprising a second reservoir connected to the exit port assembly.
  28. 28. A device according to Claim 20, further comprising:
    an expandable bolus accumulator connected to the reservoir; and at least one user interface component accessible from an exterior of the housing for opening fluid flow between the bolus accumulator and the exit port assembly.
  29. 29. A device according to Claim 1, wherein the dispenser includes an expandable accumulator, an inlet valve controlling flow from a reservoir into the accumulator and an outlet valve controlling flow between the accumulator and the exit port assembly.
  30. 30. A device according to Claim 1, wherein the dispenser comprises a pump for pumping fluid from a reservoir to the exit port assembly.
  31. 31. A device according to Claim 1, further including at least one sensor connected to the local processor and comprising at least one of an occlusion detector, a reservoir volume transducer, a reservoir empty detector, a leak detector, a pressure transducer, a fluid contact detector, an impedance monitor, a voltage detector, a photodetector, and a vibration monitor.
  32. 32. A device according to Claim 1, further comprising an alarm connected to the local processor.
  33. 33. A device according to Claim 1, further comprising adhesive on an exterior of the housing.
  34. 34. A device according to Claim 33, wherein the adhesive is provided in at least one continuous band surrounding the exit port assembly.
  35. 35. A device according to Claim 1, wherein the exit port assembly is mounted in a recessed portion of the housing.
  36. 36. A device according to Claim 1, wherein the housing is flexible.
  37. 37. A device according to Claim 36, wherein the housing includes hinge sections.
  38. 38. A device according to Claim 1, wherein the housing includes a window.
  39. 39. A device according to Claim 1, wherein the housing includes vent holes.
  40. 40. A device according to Claim 1, wherein the local processor and the receiver are encapsulated in an electromagnetic shielding material.
  41. 41. A device according to Claim 40, wherein the receiver includes an antenna extending out of the electromagnetic shielding material.
  42. 42. A device according to Claim 1, wherein the local processor includes programming which can be updated by a remote control device.
  43. 43. A system including a fluid delivery device according to Claim l, and further comprising a remote control device separate from the fluid delivery device and including:
    a remote processor;
    user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor, and a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device.
  44. 44. A system according to Claim 43, further comprising a proximity alarm.
  45. 45. A kit including a system according to Claim 43, and further comprising a subcutaneous patient access tool for connection to the exit port assembly of the fluid delivery device.
  46. 46. A kit according to Claim 45, including a single remote control device, and a plurality of fluid delivery devices.
  47. 47. A kit according to Claim 46, wherein each fluid delivery device includes a bar code and the remote control device includes a bar code scanner.
  48. 48. A device for delivering fluid to a patient, comprising:
    an exit port assembly adapted to connect to a transcutaneous patient access tool;
    a dispenser for causing fluid from a reservoir to flow to the exit port assembly;
    a local processor connected to the dispenser and programmed to cause fluid flow to the exit port assembly based upon flow instructions, and further programmed to provide flow information;
    a wireless transmitter connected to the local processor for transmitting the flow information from the local processor to a separate, remote control device; and a housing containing the exit port assembly, the dispenser, the local processor, and the wireless transmitter;
    wherein the housing is free of user output components for providing the flow information from the local processor to a user.
  49. 49. ~A device according to Claim 48, wherein the local processor is programmed to receive at least some of the flow instructions from a separate, remote control device, and the device further includes a wireless receiver connected to the local processor for receiving the flow instructions from a separate, remote control device and delivering the flow instructions to the local processor.
  50. 50. ~A system including a fluid delivery device according to Claim 48, and further comprising a remote control device separate from the fluid delivery device and including:
    a remote processor;

    user output components connected to the remote processor for allowing a user to receive flow information, and a receiver connected to the remote processor for receiving the flow information from the transmitter of the fluid delivery device.
  51. 51. ~A system for delivering a fluid to a patient, comprising:
    a) a fluid delivery device for attachment to a skin surface of a patient and including, an exit port assembly adapted to connect to a transcutaneous patient access tool, a dispenser for causing fluid from a reservoir to flow to the exit port assembly, a local processor connected to the dispenser and programmed to cause a flow of fluid to the exit port assembly based at least in part on received flow instructions, and further programmed to provide flow information, a wireless receiver connected to the local processor for receiving the flow instructions and delivering the flow instructions to the local processor, a wireless transmitter connected to the local processor for transmitting the flow information from the local processor, and a housing containing the exit port assembly, the dispenser, the local processor, the wireless receiver, and the wireless transmitter, wherein the housing is free of user input components for providing flow instructions to the local processor; and b) a remote control device separate from the fluid delivery device and including, user input components for receiving user inputs, user output components for providing user outputs, a remote processor connected to the user input components and programmed to provide the flow instructions based on the user inputs, and connected to the user output components to provide user outputs based upon the flow information, a wireless transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device, and a wireless receiver connected to the remote processor for receiving the flow information from the transmitter of the fluid delivery device.
CA2421133A 2000-09-08 2001-08-31 Devices, systems and methods for patient infusion Expired - Lifetime CA2421133C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2771723A CA2771723C (en) 2000-09-08 2001-08-31 Devices, systems and methods for patient infusion

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US23147600P 2000-09-08 2000-09-08
US60/231,476 2000-09-08
PCT/US2001/027108 WO2002020073A2 (en) 2000-09-08 2001-08-31 Devices, systems and methods for patient infusion

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2771723A Division CA2771723C (en) 2000-09-08 2001-08-31 Devices, systems and methods for patient infusion

Publications (2)

Publication Number Publication Date
CA2421133A1 true CA2421133A1 (en) 2002-03-14
CA2421133C CA2421133C (en) 2012-06-26

Family

ID=22869381

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2421133A Expired - Lifetime CA2421133C (en) 2000-09-08 2001-08-31 Devices, systems and methods for patient infusion
CA2771723A Expired - Lifetime CA2771723C (en) 2000-09-08 2001-08-31 Devices, systems and methods for patient infusion

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2771723A Expired - Lifetime CA2771723C (en) 2000-09-08 2001-08-31 Devices, systems and methods for patient infusion

Country Status (11)

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US (4) US6740059B2 (en)
EP (1) EP1335764B1 (en)
JP (1) JP2004521667A (en)
CN (1) CN1471413A (en)
AT (1) ATE363922T1 (en)
AU (2) AU8857501A (en)
CA (2) CA2421133C (en)
DE (1) DE60128826T2 (en)
DK (1) DK1335764T3 (en)
ES (1) ES2287156T3 (en)
WO (1) WO2002020073A2 (en)

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US20050171512A1 (en) 2005-08-04
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DK1335764T3 (en) 2007-10-01
CA2421133C (en) 2012-06-26
US20040087894A1 (en) 2004-05-06
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US7029455B2 (en) 2006-04-18
US20020072733A1 (en) 2002-06-13
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US7137964B2 (en) 2006-11-21
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DE60128826T2 (en) 2008-02-07
EP1335764B1 (en) 2007-06-06
US6740059B2 (en) 2004-05-25
ATE363922T1 (en) 2007-06-15
US20030097092A1 (en) 2003-05-22
AU2001288575B2 (en) 2006-06-01

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