Constant rate fluid delivery device with selectable flow rate and titratable bolus button

• US 8,771,227 B2
• Filed: 02/13/2004
• Issued: 07/08/2014
• Est. Priority Date: 08/18/2000
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Connelly, Robert I., Powell, Kenneth G.
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US10/777,078
• Publication Number:
  US 20040162518A1
• Time in Patent Office: 3,798 Days
• Field of Search: 604131-151, 604/890.1, 604/891.1, 60428801-28804, 604248-256
• US Class Current: 604/131
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14586 pressurised by means of a flexible diaphragm
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28

Abstract

A wearable, self-contained drug infusion device is disclosed that is capable of achieving the precise flow rate control needed for dose-critical drugs such as insulin. In preferred embodiments of the device, at least two flow channels are utilized in conjunction with a series of valves for providing a user with selectable, constant flow rate control. The device can be made with small dimensions so that it can be worn by the user with a minimum of discomfort and inconvenience. In addition, the simple mechanical nature of the device provides the user with close control over the flow rate, which is required for safe and effective delivery of insulin and other drugs. Also, the absence of electronic components allows the device to be manufactured inexpensively. The device is provided with a first channel that is long and narrow, functioning as a flow restrictor. The first channel is preferably provided in a serpentine pattern. A second channel is also provided that has a larger cross section so that flow is not restricted. A series of valves are used to force the flow of fluid through a selectable portion of the serpentine portion of the first channel before entering the remainder of the second channel and flowing to the delivery cannula. In one embodiment of the device, a needle port is provided in fluid communication with the delivery cannula for delivering bolus injections. In another embodiment, a bolus button is provided for delivering bolus injections. A flow restrictor is preferably included in the bolus button to limit the rate at which the bolus button refills.

Claims

1. A device for delivering fluid at a constant selectable flow rate comprising:

a housing;

a reservoir in said housing for containing a supply of said fluid and for delivering said fluid under pressure;

a primary restrictor channel and a rate selector channel each having a proximal end and a distal end, said reservoir being in fluid communication with the proximal end of at least one of said primary restrictor channel and said rate selector channel; and

a delivery cannula in fluid communication with said distal end of at least one of said primary restrictor and selector channels for delivering said fluid;

said primary restrictor channel comprising a plurality of sections;

said rate selector channel comprising a plurality of series-connected sections separated by nodes, each section of said rate selector channel being arranged in parallel to a corresponding section of said primary restrictor channel, and each node being in fluid communication with a corresponding section of said primary restrictor channel and capable of being closed, such that when a particular node is closed, fluid flowing from said reservoir toward said cannula may not pass through the node but rather must pass through the corresponding section of said primary restrictor channel;

said nodes being manipulable to select a flow rate.

2. A device as claimed in claim 1, wherein said reservoir comprises at least one spring element for pressurizing said fluid contained in said reservoir.

3. A device as claimed in claim 2, wherein said spring element is a Belleville spring.

4. A device as claimed in claim 1 wherein said primary restrictor and rate selector channels are formed into said housing.

5. A device as claimed in claim 4 wherein at least one wall of said flow channels is formed by a flexible membrane.

6. A device as claimed in claim 1, wherein said rate selector channel has a greater cross sectional area than said primary restrictor channel.

7. A device as claimed in claim 1 wherein said primary restrictor channel is formed in a serpentine pattern.

8. A device as claimed in claim 1 further having a resealable port in fluid communication with said delivery cannula for immediate delivery of additional fluid.

9. The device as claimed in claim 1 further comprising a self sealing needle port in fluid communication with said delivery cannula.

10. A method of injecting medication into a patient comprising the steps of:

providing a pressurized container of medicament in fluid communication with a proximal end of at least one of a primary restrictor channel and a rate selector channel, at least one of said primary restrictor channel and said rate selector channel having a distal end in fluid communication with a cannula, said rate selector channel comprising a plurality of series-connected sections separated by nodes, each section of said rate selector channel being arranged in parallel to a corresponding section of said primary restrictor channel, and each node being in fluid communication with a section of said primary restrictor channel, each of said nodes being constructed such that when said node is in a closed position, fluid is not able to flow through said node from said primary restrictor channel to said rate selector channel;

injecting said cannula into said patient;

manipulating said nodes to close a selected number of nodes; and

delivering said medicament to said patient through said flow channels and said cannula at a flow rate determined by said selected number of nodes.

11. The method of claim 10 wherein said providing step further comprises providing said pressurized container of medicament in a container comprising at least one flexible membrane sealed to a substantially flat surface.

12. The method of claim 11 further comprising pressurizing said medicament by flexing a spring against said container.

13. The method of claim 12 wherein said spring comprises a Belleville spring.

14. The method of claim 10, wherein said primary restrictor channel has a substantially longer length and smaller cross section than said rate selector channel.