FLUID INFUSION METHOD AND SYSTEM THEREFOR

• US 20050126304A1
• Filed: 11/23/2004
• Published: 06/16/2005
• Est. Priority Date: 11/24/2003
• Status: Abandoned Application

• Current Assignee: Integrated Sensing Systems Incorporated
• Original Assignee: Integrated Sensing Systems Incorporated
• Inventors: Goldner, Stephen Jeffrey, Najafi, Nader, Sparks, Douglas Ray
• Application Number:
  US10/904,690
• Publication Number:
  US 20050126304A1
• Time in Patent Office: Days
• US Class Current: 73/861.50
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/0294 Piezoelectric materials
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G01F 1/8445 micromachined flowmeters

Abstract

A system and method for delivering a precise amount of fluid, such as a fluid for medical treatment. The system is a compact, fully-integrated, assembly that includes a sheet configured to be secured to a patient so that a surface of the sheet is held in contact with the patient'"'"'s skin. The sheet carries a reservoir containing the fluid, a flow sensing device fluidically coupled to the reservoir, a device for initiating and interrupting flow of the fluid from the reservoir to the flow sensing device, a device for introducing the fluid into the patient'"'"'s body, electronic circuitry for controlling fluid flow based on the output of the flow sensing device, and a power source.

Claims

1. A system for delivering a fluid into the body of a patient, the system comprising:

a sheet having oppositely-disposed first and second surfaces;

means for securing the sheet to a surface of the body of the patient so that the first surface of the sheet is held in contact with the surface of the body;

a reservoir supported on the sheet and containing the fluid;

a flow sensing device supported on the sheet and fluidically coupled to the reservoir, the flow sensing device generating at least one output signal based on flow of the fluid through the flow sensing device;

means supported on the sheet for initiating and interrupting flow of the fluid from the reservoir and through the flow sensing device;

means supported on the sheet and fluidically coupled to the flow sensing device for introducing into the body through the surface thereof the fluid that flows from the reservoir and through the flow sensing device;

electronic circuitry supported on the sheet and having means for receiving the output signal from the flow sensing device and means for controlling the flow initiating and interrupting means; and

means supported on the sheet for powering the flow sensing device, the flow initiating and interrupting means, and the electronic circuitry.

2. The system according to claim 1, wherein the flow sensing device is configured to produce a first output signal corresponding to the density of the fluid flowing therethrough and produce a second output signal corresponding to the mass flow rate of the fluid flowing therethrough.

3. The system according to claim 1, wherein the electronic circuitry produces an electrical output based on the output signal of the flow sensing device, the system further comprises means supported on the sheet for communication between the electronic circuitry and at least one remote device that is not physically coupled to the system, and the communication means relays the electrical output to the remote device.

4. The system according to claim 3, wherein the output signal of the flow sensing device corresponds to a volumetric flow rate of the fluid flowing through the flow sensing device, the system further comprising means for measuring elapsed time during which the fluid has flowed through the flow sensing device.

5. The system according to claim 4, wherein the electronic circuitry is operable to cause the flow initiating and interrupting means to stop flow of the fluid through the flow sensing device in response to the elapsed time measured by the measuring means and the output signal of the flow sensing device.

6. The system according to claim 1, wherein the output signal of the flow sensing device corresponds to a volumetric flow rate of the fluid flowing through the flow sensing device.

7. The system according to claim 6, wherein the electronic circuitry is operable to cause the flow initiating and interrupting means to selectively increase and decrease flow of the fluid through the flow sensing device in response to the output signal of the flow sensing device.

8. The system according to claim 1, further comprising means supported on the sheet for communication between the electronic circuitry and at least one remote device that is not physically coupled to the system, wherein the electronic circuitry is operable to cause the flow initiating and interrupting means to selectively initiate, increase, decrease, and interrupt flow of the fluid through the flow sensing device in response to a signal received from the remote device via the communication means.

9. The system according to claim 1, wherein the flow sensing device is configured to operate on the basis of the Coriolis effect to measure the density and the mass flow rate of the fluid flowing therethrough.

10. The system according to claim 1, wherein the securing means is an adhesive on the first surface of the sheet.

11. The system according to claim 1, wherein the introducing means comprises means for injecting the fluid beneath the surface of the body.

12. The system according to claim 1, wherein the introducing means comprises a needle on the first surface of the sheet.

13. The system according to claim 1, wherein the introducing means comprises means for causing transdermal absorption of the fluid into the surface of the body.

14. The system according to claim 1, wherein the reservoir, the flow sensing device, the flow initiating and interrupting means, the electronic circuitry, and the powering means are supported on the second surface of the sheet.

15. The system according to claim 14, wherein the securing means is an adhesive on the first surface of the sheet.

16. The system according to claim 15, wherein the introducing means comprises means for injecting the fluid beneath the surface of the body.

17. The system according to claim 15, wherein the introducing means comprises means for causing transdermal absorption of the fluid into the surface of the body.

18. The system according to claim 1, wherein the fluid within the reservoir is at a pressure above atmospheric pressure.

19. The system according to claim 1, further comprising means supported on the sheet for communication between the electronic circuitry and at least one remote device that is not physically coupled to the system, wherein the output signal of the flow sensing device corresponds to a volumetric flow rate of the fluid flowing through the flow sensing device, the communication means relays an input signal from the remote device to the electronic circuitry, and the electronic circuitry is operable to cause the flow initiating and interrupting means to selectively initiate, increase, decrease, and interrupt flow of the fluid through the flow sensing device in response to the output signal of the flow sensing device and the input signal of the remote device.

20. The system according to claim 19, wherein the input signal received from the remote device corresponds to a parameter of the body of the patient sensed by the remote device.

21. The system according to claim 1, further comprising at least a second reservoir supported on the sheet and containing a second fluid.

22. The system according to claim 21, wherein the system is operative to mix the fluid and the second fluid before the fluid and the second fluid are introduced into the body by the introducing means.

23. The system according to claim 21, wherein the system is operative to separately introduce the fluid and the second fluid into the body through the surface thereof.

24. A method for delivering a fluid into the body of a patient, the method comprising:

providing a sheet have a fluid infusion system thereon, the fluid infusion system comprising a reservoir containing the fluid, a flow sensing device fluidically coupled to the reservoir, and electronic circuitry;

applying the sheet to a surface of the body of the patient so that a first surface of the sheet is held in contact with the surface of the body;

operating the electronic circuitry to initiate flow of the fluid from the reservoir and through the flow sensing means, and to receive from the flow sensing device an output signal based on flow of the fluid through the flow sensing device; and

introducing through the surface of the body the fluid that has flowed from the reservoir and through the flow sensing device.

25. The method according to claim 24, wherein the flow sensing device produces a first output signal corresponding to the density of the fluid flowing therethrough and produces a second output signal corresponding to the mass flow rate of the fluid flowing therethrough.

26. The method according to claim 24, wherein the electronic circuitry produces an electrical output based on the output signal of the flow sensing device, and the electrical output is relayed to at least one remote device.

27. The method according to claim 26, wherein the output signal of the flow sensing device corresponds to a volumetric flow rate of the fluid flowing through the flow sensing device, the method further comprising measuring elapsed time during which the fluid has flowed through the flow sensing device.

28. The method according to claim 27, further comprising the step of stopping flow of the fluid through the flow sensing device in response to the elapsed time and the output signal of the flow sensing device.

29. The method according to claim 24, wherein the output signal of the flow sensing device corresponds to a volumetric flow rate of the fluid flowing through the flow sensing device, the method further comprising the steps of selectively increasing and decreasing flow of the fluid through the flow sensing device in response to the output signal of the flow sensing device.

30. The method according to claim 24, wherein the first surface of the sheet is held in contact with the surface of the body by an adhesive on the first surface of the sheet.

31. The method according to claim 24, wherein the introducing step comprises injecting the fluid beneath the surface of the body.

32. The method according to claim 24, wherein the introducing step comprises transdermal absorption of the fluid into the surface of the body.

33. The method according to claim 24, further comprising the steps of selectively initiating, increasing, decreasing, and interrupting flow of the fluid through the flow sensing device in response to a signal received from at least one remote device.

34. The method according to claim 24, wherein the output signal of the flow sensing device corresponds to a volumetric flow rate of the fluid flowing through the flow sensing device, the method further comprises the steps of relaying an input signal from at least one remote device to the electronic circuitry, and the electronic circuitry selectively initiates, increases, decreases, and interrupts flow of the fluid through the flow sensing device in response to the output signal of the flow sensing device and the input signal of the remote device.

35. The method according to claim 34, wherein the input signal received from the remote device corresponds to a parameter of the body of the patient sensed by the remote device.

36. The method according to claim 24, wherein the fluid infusion system comprises a second reservoir containing a second fluid and a second flow sensing device fluidically coupled to the second reservoir, and the electronic circuitry controls delivery of the second fluid from the second reservoir, through the second flow sensing means, and through the surface of the body.

37. The method according to claim 36, wherein the electronic circuitry causes the second fluid to be delivered from the second reservoir, through the second flow sensing means, and through the surface of the body simultaneously with the delivery of the fluid from the reservoir, through the flow sensing means, and through the surface of the body.

38. The method according to claim 24, wherein the fluid infusion system comprises a second reservoir containing a second fluid, and the electronic circuitry controls delivery of the second fluid from the second reservoir and mixing of the second fluid with the fluid from the reservoir prior to introducing the fluid and the second fluid through the surface of the body.

39. The method according to claim 24, further comprising the step of removing the sheet and its fluid infusion system from the surface of the body and discarding the sheet and its fluid infusion system.

40. The method according to claim 24, further comprising the step of removing the sheet and its fluid infusion system from the surface of the body and discarding at least one of the reservoir and the flow sensing device.