DEVICES, SYSTEMS AND METHODS FOR PATIENT INFUSION

• US 20050171512A1
• Filed: 12/07/2004
• Published: 08/04/2005
• Est. Priority Date: 09/08/2000
• Status: Abandoned Application

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Flaherty, J. Christopher
• Application Number:
  US10/904,960
• Publication Number:
  US 20050171512A1
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• 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: G16H 20/17 delivered via infusion or injection

Abstract

A method for transcutaneously delivering fluid to a patient including providing at least one disposable infusion pump, wherein the pump includes a housing adapted to be mounted on a patient'"'"'s skin, a transcutaneous patient access tool for extending through the housing and providing transcutaneous access to the patient, a reservoir prefilled with a therapeutic fluid, a dispenser for causing fluid from the reservoir to flow to the transcutaneous patient access tool, a processor connected to the dispenser and programmed to cause a flow of fluid from the reservoir to the transcutaneous patient access tool based on flow instructions, and a wireless receiver connected to the processor for receiving flow instructions from a remote controller and for delivering the flow instructions to the processor.

Claims

1. A method for transcutaneously delivering fluid to a patient, comprising the steps of:

a) providing at least one disposable infusion pump including,

a housing adapted to be mounted on a patient'"'"'s skin,

a transcutaneous patient access tool for extending through the housing and providing transcutaneous access to the patient,

a reservoir prefilled with a therapeutic fluid,

a dispenser for causing fluid from the reservoir to flow to the transcutaneous patient access tool,

a processor connected to the dispenser and programmed to operate the dispenser so that fluid from the reservoir flows to the transcutaneous patient access tool based on flow instructions, and

a wireless receiver connected to the processor for receiving flow instructions from a remote controller and for delivering the flow instructions to the processor;

b) placing the disposable infusion pump on a patient'"'"'s skin;

c) receiving flow instructions from a remote controller through the wireless receiver of the infusion pump; and

d) delivering the flow instructions to the processor of the infusion pump, so that the processor causes fluid from the reservoir to flow to the transcutaneous patient access tool based on the flow instructions.

2. A method according to claim 1, wherein the reservoir is prefilled with a therapeutic fluid that comprises one of insulin, antibiotics, nutritional fluids, total parenteral nutrition or TPN, analgesics, morphine, hormones or hormonal drugs, gene therapy drugs, anticoagulants, analgesics, cardiovascular medications, AZT or chemotherapeutics.

3. A method according to claim 1, wherein the reservoir is prefilled with a therapeutic fluid for treating one of diabetes, cardiovascular disease, pain, chronic pain, cancer, AIDS, neurological diseases, Alzheimer'"'"'s Disease, ALS, Hepatitis, Parkinson'"'"'s Disease or spasticity.

4. A method according to claim 1, further comprising the step of adapting the prefilled reservoir so that the reservoir is not refillable.

5. A method according to claim 1, further comprising the step of providing each of the infusion pumps with an identification tag.

6. A method according to claim 5, further comprising the step of providing each of the identification tags with information regarding the therapeutic fluid contained in the prefilled reservoir, and wherein the information includes amount, type, concentration and an expiration date of the therapeutic fluid.

7. A method according to claim 6, wherein the identification tags comprise barcode labels.

8. A method according to claim 1, further comprising the step of providing the processor with memory containing information regarding the therapeutic fluid contained in the prefilled reservoir, and wherein the information includes amount, type, concentration and an expiration date of the therapeutic fluid.

9. A method according to claim 1, further comprising the step of providing a plurality of the infusion pumps in a single sterilized package.

10. A method according to claim 1, further comprising the step of providing the infusion pump with a non-replaceable power supply.

11. A method according to claim 1, further comprising the steps of providing the infusion pump with skin attachment adhesive, and attaching the infusion pump to the skin of a patient using the skin attachment adhesive prior to receiving the flow instructions.

12. A method according to claim 1, further comprising the step of freeing the housings, of each of the disposable infusion pumps, of user input components for supplying flow instructions to the processor.

13. A method according to claim 12, further comprising the steps of placing the infusion pump on the patient'"'"'s skin and extending the transcutaneous patient access tool from the housing such that the transcutaneous patient access tool penetrates the patient'"'"'s skin, prior to receiving the flow instructions.

14. A method according to claim 13, further comprising providing each of the disposable infusion pumps with means for automatically deploying the transcutaneous patient access tool from the housing and into the patient'"'"'s skin.

15. A method according to claim 1, further comprising the step of remotely supplying flow instructions to each of the disposable infusion pumps through a reusable remote control device.

16. A method according to claim 15, further comprising the step of adapting the reusable remote control device to be successively used with the disposable infusion pumps.

17. A method according to claim 15, further comprising the step of providing the reusable remote control device with a replaceable power supply.

18. A method according to claim 15, further comprising the step of packaging one of the remote control devices and a plurality of the infusion pumps in a single sterilized package.

19. A method according to claim 15, further comprising the steps of providing the remote control device with a glucometer and using the glucometer to measure a level of sugar within the patient'"'"'s blood.

20. A method according to claim 16, further comprising the steps of providing each disposable infusion pump with a barcode label containing information regarding the therapeutic fluid contained in the prefilled reservoir, providing the remote control device with a barcode scanner, and reading each of the barcode labels using the barcode scanner.

21. A disposable infusion pump comprising:

a housing adapted to be mounted on a patient'"'"'s skin;

a transcutaneous patient access tool for extending through the housing and providing transcutaneous access to the patient;

a reservoir prefilled with a therapeutic fluid;

a dispenser for causing fluid from the reservoir to flow to the transcutaneous patient access tool;

a processor connected to the dispenser and programmed to operate the dispenser so that fluid from the reservoir flows to the transcutaneous patient access tool based on flow instructions; and

a wireless receiver connected to the processor for receiving flow instructions from a remote controller and for delivering the flow instructions to the processor.

22. A disposable infusion pump according to claim 21, wherein the reservoir is prefilled with a therapeutic fluid that comprises one of insulin, antibiotics, nutritional fluids, total parenteral nutrition or TPN, analgesics, morphine, hormones or hormonal drugs, gene therapy drugs, anticoagulants, analgesics, cardiovascular medications, AZT or chemotherapeutics.

23. A disposable infusion pump according to claim 21, wherein the reservoir is prefilled with a therapeutic fluid for treating one of diabetes, cardiovascular disease, pain, chronic pain, cancer, AIDS, neurological diseases, Alzheimer'"'"'s Disease, ALS, Hepatitis, Parkinson'"'"'s Disease or spasticity.

24. A disposable infusion pump according to claim 21, wherein the prefilled reservoir is non-refillable.

25. A disposable infusion pump according to claim 21, further comprising an identification tag.

26. A disposable infusion pump according to claim 25, wherein the identification tag includes information regarding the therapeutic fluid contained in the prefilled reservoir, and wherein the information includes amount, type, concentration and an expiration date of the therapeutic fluid.

27. A disposable infusion pump according to claim 26, wherein the identification tag comprises a barcode label.

28. A disposable infusion pump according to claim 21, wherein the processor includes memory containing information regarding the therapeutic fluid contained in the prefilled reservoir, and wherein the information includes amount, type, concentration and an expiration date of the therapeutic fluid.

29. A disposable infusion pump according to claim 21, further comprising a non-replaceable power supply contained in the housing and connected to the processor.

30. A disposable infusion pump according to claim 21, further comprising skin attachment adhesive on an exterior surface of the housing.

31. A disposable infusion pump according to claim 21, wherein the housing is free of user input components for supplying flow instructions to the processor.

32. A disposable infusion pump according to claim 21, wherein the transcutaneous patient access tool includes a sharpened tip for penetrating the patient'"'"'s skin, and the disposable infusion pump includes means for automatically deploying the transcutaneous patient access tool from the housing and into the patient'"'"'s skin.

33. A system including a disposable infusion pump according to claim 21, and further comprising a reusable remote control device for wirelessly providing flow instructions to the receiver of the disposable infusion pump.

34. A system according to claim 33, comprising one of the reusable remote control devices and a plurality of the disposable infusion pumps.

35. A system according to claim 33, wherein the remote control device includes a glucometer.

36. A method for distributing therapeutic fluids to patients, comprising the steps of:

a) providing disposable infusion pumps to each patient, wherein the pumps each include,

a housing adapted to be mounted on a patient'"'"'s skin,

a transcutaneous patient access tool for extending through the housing and providing transcutaneous access for fluid to the patient,

a reservoir prefilled with a therapeutic fluid,

a dispenser for causing fluid from the reservoir to flow to the transcutaneous patient access tool,

a processor connected to the dispenser and programmed to operate the dispenser so that fluid from the reservoir flows to the transcutaneous patient access tool based on flow instructions, and

a wireless receiver connected to the processor for receiving flow instructions from a remote control device and for delivering the flow instructions to the processor,

wherein each infusion pump is adapted to be used only once for a predetermined period; and

b) providing a reusable remote control device to each patient, wherein the remote control device is adapted to be used with only one of the disposable infusion pumps at any one time, and wherein the remote control device is adapted to provide flow instructions to the wireless receiver of the disposable infusion pump.

37. A method according to claim 36, wherein the reservoirs of the disposable infusion pumps are prefilled with a therapeutic fluid that comprises one of insulin, antibiotics, nutritional fluids, total parenteral nutrition or TPN, analgesics, morphine, hormones or hormonal drugs, gene therapy drugs, anticoagulants, analgesics, cardiovascular medications, AZT or chemotherapeutics.

38. A method according to claim 36, wherein the reservoirs of the disposable infusion pumps are prefilled with a therapeutic fluid for treating one of diabetes, cardiovascular disease, pain, chronic pain, cancer, AIDS, neurological diseases, Alzheimer'"'"'s Disease, ALS, Hepatitis, Parkinson'"'"'s Disease or spasticity.

39. A method according to claim 36, further comprising the step of adapting the prefilled reservoirs of the disposable infusion pumps so that the reservoirs are not refillable.

40. A method according to claim 36, further comprising the step of providing each of the infusion pumps with an identification tag.

41. A method according to claim 40, further comprising the step of providing each of the identification tags with information regarding the therapeutic fluid contained in the prefilled reservoir, and wherein the information includes amount, type, concentration and an expiration date of the therapeutic fluid.

42. A method according to claim 41, wherein the identification tags comprise barcode labels.

43. A method according to claim 36, further comprising the step of providing the processors of the disposable infusion pumps with memory containing information regarding the therapeutic fluid contained in the prefilled reservoirs, and wherein the information includes amount, type, concentration and an expiration date of the therapeutic fluid.

44. A method according to claim 36, further comprising the step of providing a plurality of the infusion pumps in a single sterilized package for distribution to patients.

45. A method according to claim 36, further comprising the step of providing the infusion pumps with non-replaceable power supplies.

46. A method according to claim 36, further comprising the steps of providing the infusion pumps with skin attachment adhesive, so that the infusion pumps can be attached and secured to the skin of a patient using the skin attachment adhesive prior to receiving the flow instructions from the remote control device.

47. A method according to claim 36, further comprising the step of freeing the housings, of each of the disposable infusion pumps, of user input components for supplying flow instructions to the processor.

48. A method according to claim 47, further comprising the steps of:

providing the transcutaneous patient access tools of the infusion pumps with sharpened distal ends for penetrating the patient'"'"'s skin; and

extending the transcutaneous patient access tool from the housing upon placing the infusion pumps on the patient'"'"'s skin so that the transcutaneous patient access tool penetrates the patient'"'"'s skin, prior to receiving the flow instructions from the remote control device.

49. A method according to claim 48, further comprising the step of providing each of the disposable infusion pumps with means for automatically deploying the transcutaneous patient access tool from the housing and into the patient'"'"'s skin.

50. A method according to claim 36, further comprising the step of providing the reusable remote control device with a replaceable power supply.

51. A method according to claim 36, further comprising the step of packaging one of the remote control devices and a plurality of the infusion pumps in a single sterilized package for distribution to new patients.

52. A method according to claim 36, further comprising the step of providing the remote control device with a glucometer.

53. A method according to claim 36, further comprising the steps of providing each disposable infusion pump with a barcode label containing information regarding the therapeutic fluid contained in the prefilled reservoirs, and providing the remote control device with a barcode scanner.