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

• US 9,937,290 B2
• Filed: 07/07/2014
• Issued: 04/10/2018
• 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:
  US14/324,839
• Publication Number:
  US 20150011937A1
• Time in Patent Office: 1,373 Days
• 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;

an adjustable flow channel having a proximal end and a distal end and a selectable flow distance therebetween, said proximal end being in fluid communication with said reservoir; and

a delivery cannula in fluid communication with said distal end of said flow channel for delivering said fluid;

wherein said selectable flow distance is determined by opening and closing a plurality of valves, the plurality of valves comprising a plurality of detents rotatably alignable with a plurality of indentations with a flexible membrane therebetween, each valve being in fluid communication with a corresponding flow section of said flow channel, and each corresponding flow section of said flow channel is a portion of said selectable flow distance, thereby providing an adjustable flow rate through said flow channel by variation of said selectable flow distance of said flow channel.

2. A device as claimed in claim 1 wherein a portion of said flow channel is formed into said housing.

3. A device as claimed in claim 2 wherein at least one wall of said flow channel is formed by the flexible membrane.

4. A device as claimed in claim 3 wherein said valves are defined by indentations in said housing, said device further having a flow rate selection device movably connected to said housing, said flexible membrane disposed between said housing and said flow rate selection device, said flow rate selection device further having a plurality of detents adapted to match said indentations such that said detents may be moved into alignment with any number of said indentations causing the corresponding valves to be closed.

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

6. A device as claimed in claim 5, wherein said spring element is a disc spring.

7. 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.

8. A device as claimed in claim 7, wherein said flow channel further comprises a check valve adapted to prevent the flow of fluid toward said reservoir.

9. A device as claimed in claim 1, wherein a first flow section has a greater cross sectional area than a second flow section.

10. A device as claimed in claim 1 wherein said flow channel is formed in a serpentine pattern.

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

12. A device as claimed in claim 1, wherein said flow channel further comprises a check valve adapted to prevent the flow of fluid toward said reservoir.