Infusion System for the Controlled Delivery of Therapeutic Agents

• US 20140276587A1
• Filed: 03/13/2014
• Published: 09/18/2014
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: InCube Labs LLC. (In-Cube, Inc.)
• Original Assignee: InCube Labs LLC. (In-Cube, Inc.)
• Inventors: Imran, Mir
• Granted Patent: US 9,597,449 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure

Abstract

Embodiments of the invention provide infusion systems for the intravenous or other delivery of drugs and other therapeutic agents to a patient including a human or mammal. The therapeutic agents may be dissolved in solution or comprise the solution itself. Embodiments of the systems can utilize a chemical reaction to predictably drive a flow of drug(s) through a catheter or other flow path and into the patient. More specifically, the reaction may include an acid-base reaction or any other reaction that produces a gaseous substance. The gas is produced and contained in an expandable drive balloon when the acid-base reactants are combined with a liquid. As the gas is produced, the drive balloon expands to exert pressure on a separately-contained drug reservoir which, in turn, pushes drug(s) from the reservoir into the flow path where the drug is ultimately delivered to the patient in a controlled and predetermined manner.

Claims

1. A system for delivering a therapeutic agent to a patient, the system comprising:

a reservoir configured to contain a solution comprising the therapeutic agent;

a non-compliant housing containing the reservoir,

a flow path having a first end and a second end, the first end coupled to the reservoir;

an expandable drive balloon disposed within the rigid housing in at least a partially non-expanded state;

wherein the drive balloon includes a first section and a second section, each section separated by a releasable seal;

wherein the first section includes a liquid and the second section includes at least one reactant configured to chemically react with the liquid to produce a gas which expands the drive balloon;

wherein when the seal is released, the liquid from the first section mixes with the reactant(s) in the second section to produce the gas which expands the drive balloon to exert a pressure on the reservoir to push the therapeutic agent solution into the flow path;

a delivery body having a proximal portion and a distal portion, the proximal portion coupled to the second end of the flow path and the distal portion configured to deliver the therapeutic agent to the patient; and

wherein a fluidic resistance of the flow path and the pressure exerted on the reservoir are configured to deliver the therapeutic agent to the patient at a flow rate within a pre-determined range during use.

2. The system of claim 1, wherein the reactants include an acid and a base in a ratio of about 1:

2, respectively.

3. The system of claim 2, wherein the acid is citric acid or acetic acid and the base is sodium bicarbonate or sodium hydroxide.

4. The system of claim 1, wherein the liquid is water.

5. The system of claim 1, wherein the gas is carbon dioxide.

6. The system of claim 1, wherein the flow rate is between about 10 cc/min and 500 cc/min.

7. The system of claim 1, wherein the flow rate is between about 0.5 cc/min and 20 cc/min.

8. The system of claim 1, wherein the therapeutic agent solution has a usable quantity and wherein the therapeutic agent solution is delivered to the patient at a flow rate that remains within the predetermined range substantially throughout the delivery of the useable quantity of the therapeutic agent.

9. The system of claim 1, wherein the delivery body is a hollow needle for intravenous or subcutaneous administration of the therapeutic agent to the patient.

10. The system of claim 9, wherein a fluidic resistance of the hollow needle is configured to control the flow rate of the therapeutic agent solution.

11. The system of claim 1, wherein the delivery body is a patch for transdermal administration of the therapeutic agent to the patient.

12. The system of claim 1, wherein the flow path is a catheter.

13. The system of claim 1, wherein the housing is rigid and wherein the housing includes a transparent window for viewing the reservoir and drive balloon.

14. The system of claim 13, further comprising a marker viewably positioned in the transparent window between the reservoir and the drive balloon, the marker configured to indicate a relative amount of therapeutic agent solution remaining in the reservoir.

15. The system of claim 1, wherein the housing is disposed at a height equal to or above the patient.

16. The system of claim 1, wherein the releasable seal is a pinch valve, collar valve, weak-weld seal, pressure seal, pull tab or adhesive seal.

17. The system of claim 1, further comprising the therapeutic agent solution.

18. The system of claim 17, wherein the therapeutic agent solution comprises a chemotherapy drug, anesthetic, analgesic, insulin, growth hormone, biological material or a contrast dye.

19. A system for the intravenous delivery of a drug to a patient, the drug delivered at a flow rate within a predetermined range, the system comprising:

a reservoir configured to contain a solution comprising the drug;

a rigid housing containing the reservoir,

a catheter having a first end and a second end;

wherein the first end is connected to the reservoir;

an expandable drive balloon disposed within the rigid housing in at least a partially non-expanded state;

wherein the drive balloon includes a first section and a second section, each section separated by a releasable valve;

wherein the first section includes a liquid and the second section includes at least one reactant configured to chemically react with the liquid to produce a gas which expands the drive balloon, wherein when the valve is released, the liquid from the first section mixes with the reactants(s) in the second section to produce the gas which expands the drive balloon to exert a pressure from the drive balloon to the reservoir to push the drug solution into the catheter, and

a hollow needle having a proximal end and a distal tip;

wherein the proximal end is coupled to the second end of the catheter and the distal tip is configured to deliver the drug solution to a blood vessel of the patient; and

wherein the pressure exerted on the reservoir and a fluidic resistance of at least one of the catheter or the hollow needle are configured to deliver the drug solution to the patient at a flow rate within the pre-determined range.

20. The system of claim 19, wherein the system is self-priming.

21. The system of claim 19, wherein a fluidic resistance of the hollow needle is configured to control the flow rate of the therapeutic agent solution.

22. The system of claim 19, wherein the flow rate is between about 10 cc/min and 500 cc/min.

23. The system of claim 19, wherein the flow rate is between about 0.5 cc/min and 20 cc/min.

24. A kit for the intravenous delivery of a drug to a patient, the kit comprising:

the system of claim 19; and

a drug solution disposed in the reservoir.

25. The kit of claim 24, wherein the therapeutic agent solution comprises a chemotherapy drug, anesthetic, analgesic, insulin, growth hormone, biological material or a contrast dye.

26. The kit of claim 24, further comprising a sterile package holding the housing, catheter and needle.

27. The kit of claim 24, further comprising a computing means for computing a flow rate through the catheter and needle.

50. The method of claim 28, wherein the system comprises the system of claim 19.

28. A method for delivering a therapeutic agent to a patient at a flow rate within a predetermined range, the method comprising:

providing a system for delivering a therapeutic agent solution to the patient, the system having a flow path for flow of the therapeutic agent solution to the patient, the flow path having a selected fluidic resistance, the system configured to generate a pressure for driving the therapeutic agent solution through the flow path wherein the generated pressure and the fluidic resistance are configured to deliver the therapeutic agent solution to the patient at the flow rate within the pre-determined range; and

using the system to deliver the therapeutic agent solution to the patient at the flow rate within the pre-determined range.

29. The method of claim 28, wherein the system includes a reservoir of therapeutic agent solution coupled to the flow path.

30. The method of claim 28, wherein the flow path comprises a tube or a catheter.

31. The method of claim 28, wherein the flow path includes a hollow needle at a distal end of the flow path.

32. The method of claim 31, wherein the fluidic resistance of the hollow needle controls the flow rate of the therapeutic agent solution.

33. The method of claim 28, wherein the pressure is generated by a chemical reaction within the system, the method further comprising:

reacting chemical reactants within the system to generate a gas which provides the pressure to drive the therapeutic agent solution into the flow path.

34. The method of claim 33, wherein the chemical reaction is an acid base reaction.

35. The method of claim 33, wherein at least one of the chemical reaction and the generated gas is contained in an expandable balloon which when expanded, applies pressure to the therapeutic agent solution.

36. The method of claim 35, wherein the expandable balloon includes a first and second section separated by a releasable seal, each section including a chemical reactant, the method further comprising:

releasing the seal to mix the chemical reactants; and

reacting the chemical reactants to generate the gas.

37. The method of claim 36, wherein the seal is released by means of a pullable tab or pin coupled to the seal.

38. The method of claim 28, wherein the flow rate is between about 10 cc/min. and 500 cc/min.

39. The method of claim 28, wherein the flow rate is between about 0.5 cc/min. and 20 cc/min.

40. The method of claim 28, wherein the therapeutic agent solution is delivered intravenously to the patient.

41. The method of claim 40, wherein a distal portion of the flow path includes a hollow needle which is inserted into the patient.

42. The method of claim 28, wherein the flow rate remains substantially constant over a period of delivery of therapeutic agent solution to the patient.

43. The method of claim 42, wherein the delivery period comprises a period in which substantially all of a quantity of therapeutic agent solution contained in the system is delivered to the patient.

44. The method of claim 28, wherein the flow rate varies over a period of delivery of therapeutic agent solution to the patient.

45. The method of claim 44, wherein the flow rate is varied by means of a control valve.

46. The method of claim 44, wherein the delivery period includes a first portion having a higher flow rate and a second portion having a lower flow rate.

47. The method of claim 46, wherein a bolus dose of therapeutic agent is delivered during the first portion of the delivery period and a maintenance dose is delivered during the second portion.

48. The method of claim 46, wherein the first portion of the delivery period is up to about two minutes in duration.

49. The method of claim 28, wherein the system comprises the system of claim 0.