Laminated patient infusion device

• US 6,669,669 B2
• Filed: 10/12/2001
• Issued: 12/30/2003
• Est. Priority Date: 10/12/2001
• Status: Expired due to Term

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Flaherty, J. Christopher, Garibotto, John T.
• Primary Examiner(s): Mendez, Manuel
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/977,434
• Publication Number:
  US 20030073952A1
• Time in Patent Office: 809 Days
• Field of Search: 604/151, 604/890, 604/891.1, 604/30-34, 604/65, 604/67, 604/118, 604/122, 604/123, 604/153, 604/131-133, 604/140-143, 604/187, 604/110, 604/236, 604/237, 604/288-1-2, 128/DIG.12, 222/56, 222/61, 222/189.06, 222/212, 222/213, 222/550
• US Class Current: 604/132
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 39/281 Automatic tube cut-off devices, e.g. squeezing tube on detection of air
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

A device for delivering fluid to a patient including an exit port assembly adapted to connect to a transcutaneous patient access tool, and a dispenser including at least two laminated layers of material defining a passageway connected to the exit port assembly, and an expandable accumulator in fluid communication with the passageway for controlling fluid flow from a reservoir to the exit port assembly. The laminated construction provides many benefits including simplifying the design and manufacturing of the device, in order to further reduce the size, complexity and costs of the device so that the device lends itself to being small and disposable in nature.

Claims

1. A device for delivering fluid to a patient, comprising:

A) an exit port assembly adapted to connect to a transcutaneous patient access and

B) a dispenser including,

a first layer defining a passageway connected to the exit port assembly and an opening in fluid communication with the passageway,

a resilient diaphragm received on the first layer covering the opening such that the opening and the diaphragm define an expandable accumulator,

a second layer received over the diaphragm on the first layer, the second layer having a pulse chamber over the diaphragm and in alignment with the opening of the first layer, and a port in fluid communication with the pulse chamber, and

a third layer received on the second layer and defining a secondary chamber in fluid communication with the port of the second layer,

wherein the surface of the first layer further defines an occlusion sensor recess in the passageway.

2. A device according to claim 1, wherein the surface of the first layer further defines a valve seat in the passageway.

3. A device according to claim 1, further comprising a reservoir, and the dispenser controls fluid flow from the reservoir to the exit port assembly.

4. A device according to claim 3, wherein the reservoir contains a therapeutic fluid.

5. A device according to claim 3, further comprising a fill port connected to the reservoir.

6. A device according to claim 3, wherein the reservoir is pressurized.

7. A device according to claim 1, further comprising a transcutaneous patient access tool connected to the exit port assembly.

8. A device according to claim 1, further comprising a gas permeable reservoir for containing fluid, and the dispenser control fluid flow from the reservoir to the exit port assembly.

9. A device for delivering fluid to a patient, comprising:

A) an exit port assembly adapted to connect to a transcutaneous patient access and

B) a dispenser including,

a first layer defining a passageway connected to the exit port assembly and an opening in fluid communication with the passageway,

a resilient diaphragm received on the first layer covering the opening such that the opening and the diaphragm define an expandable accumulator,

a second layer received over the diaphragm on the first layer, the second layer having a pulse chamber over the diaphragm and in alignment with the opening of the first layer, and a port in fluid communication with the pulse chamber, and

a third layer received on the second layer and defining a secondary chamber in fluid communication with the port of the second layer,

wherein the first layer further defines a reservoir and a second passageway extending between the reservoir and the accumulator.

10. A device according to claim 9, further comprising an inlet valve controlling flow from the reservoir into the accumulator, and an outlet valve controlling flow between the accumulator and the exit port assembly.

11. A device for delivering fluid to a patient, comprising:

A) an exit port assembly adapted to connect to a transcutaneous patient access and

B) a dispenser including,

a first layer defining a passageway connected to the exit port assembly and an opening in fluid communication with the passageway,

a resilient diaphragm received on the first layer covering the opening such that the opening and the diaphragm define an expandable accumulator,

a second layer received over the diaphragm on the first layer, the second layer having a pulse chamber over the diaphragm and in alignment with the opening of the first layer, and a port in fluid communication with the pulse chamber, and

a third layer received on the second layer and defining a secondary chamber in fluid communication with the port of the second layer,

wherein the first layer further defines a reservoir and a second passageway extending between the reservoir and the accumulator, and a bubble removal bay and a third passageway extending between the bubble removal bay and the reservoir.

12. A device for delivering fluid to a patient, comprising:

an exit port assembly adapted to connect to a transcutaneous patient access tool;

a dispenser including at least two laminated layers of material defining a passageway connected to the exit port assembly, and an expandable accumulator in fluid communication with the passageway;

a local processor connected to the dispenser and programmed to cause the dispenser to allow fluid flow from a reservoir 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.

13. A system comprising:

a device for delivering fluid to a patient, including;

an exit port assembly adapted to connect to a transcutaneous patient access tool;

a dispenser including at least two laminated layers of material defining a passageway connected to the exit port assembly, and an expandable accumulator in fluid communication with the passageway;

a local processor connected to the dispenser and programmed to cause the dispenser to allow fluid flow from a reservoir 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; and

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.

14. A device for delivering fluid to a patient comprising:

an exit port assembly adapted to connect to a transcutaneous patient access tool;

a dispenser including at least two laminated layers of material defining a passageway connected to the exit port assembly, and an expandable accumulator in fluid communication with the passageway;

a local processor connected to the dispenser and programmed to cause the dispenser to allow fluid flow from a reservoir to the exit port assembly based on 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.

15. A system comprising:

a device for delivering fluid to a patient, including;

an exit port assembly adapted to connect to a transcutaneous patient access tool;

a dispenser including at least two laminated layers of material defining a passageway connected to the exit port assembly, and an expandable accumulator in fluid communication with the passageway;

a local processor connected to the dispenser and programmed to cause the dispenser to allow fluid flow from a reservoir to the exit port assembly based on 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; and

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.

16. A device for delivering fluid to a patient comprising:

an exit port assembly adapted to connect to a transcutaneous patient access tool;

a dispenser including at least two laminated layers of material defining a passageway connected to the exit port assembly, and an expandable accumulator in fluid communication with the passageway;

a reservoir, and the dispenser controls fluid flow from the reservoir to the exit port assembly;

a fill port; and

a gas removal filter connecting the fill port to the reservoir.