Drug delivery device and methods therefor

• US 6,578,571 B1
• Filed: 04/19/1999
• Issued: 06/17/2003
• Est. Priority Date: 04/20/1998
• Status: Expired due to Term

• Current Assignee: Medical Developments International Ltd., Inc.
• Original Assignee: Infamed Limited
• Inventors: Watt, Paul M.
• Primary Examiner(s): Lewis, Aaron J.
• Assistant Examiner(s): MITCHELL, TEENA KAY
• Application Number:
  US09/294,759
• Time in Patent Office: 1,520 Days
• Field of Search: 128/200.14, 128/200.23, 128/204.21, 128/204.23, 128/205.23, 128/203.12, 128/203.28, 128/203.14, 128/205.13
• US Class Current: 128/200.14
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0016 located downstream of the dispenser, i.e. traversed by the product
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 2205/43 making noise when used correctly
• CPC Class Codes: A61M 2205/59 Aesthetic features, e.g. distraction means to prevent fears of child patients

Abstract

An incentive inhaler device includes an inhalation device, at least one incentive toy coupled to the inhalation device, and at least one separator. The inhalation device has a respiration device and a connector that is linkable to a delivery device. The delivery device can deliver drugs, aerosols, powder and gas. The incentive toy is respiration driven and has at least one of a visible characteristic and an audible characteristic. The separator decouples the toy from at least one component of the inhalation device to ensure directional flow of respirational air which drives the toy. The separator can include a valve, a filter, or a baffle.

Claims

1. An incentive inhaler device, comprising:

an inhalation device comprising a respiration device and a connector that is linkable to a drug delivery device such that there is a main inspiration flow of a medicament from said drug delivery device into said respiration device via said connector during inspiration by a subject through said respiration device;

at least one incentive toy coupled to the inhalation device, the toy being driven by inhaled or exhaled air passing over said toy or through said toy, wherein said toy has a visible characteristic or an audible characteristic; and

a separator element positioned so as to separate said toy from said main inspiration flow of a medicament and provide a separate air flow passage over or through said toy from or to outside said main inspiration flow, wherein said separator element includes an integer selected from the group consisting of;

a valve, a filter, and a baffle.

2. The incentive inhaler device of claim 1, wherein the separator includes at least one one-way valve.

3. The incentive inhaler device of claim 1, wherein the connector comprises:

an aperture at one end to sealably-engage the drug delivery device such that minimum leakage of the medicament occurs between the connector and the drug delivery device linked thereto; and

an end segment to releasably- and sealably-engage said connector to the respiration device.

4. The incentive inhaler device of claim 1, comprising at least one of an external visible incentive toy, an audible inhalation-driven incentive toy, and an audible exhalation-driven incentive toy.

5. The incentive inhaler device of claim 1, comprising an inhalation-driven incentive toy and an exhalation-driven incentive toy.

6. The incentive inhaler device of claim 1, comprising two incentive toys which are linked in series.

7. The incentive inhaler device of claim 1, wherein at least one incentive toy comprises a colored spinning disc.

8. The incentive inhaler device of claim 1, wherein at least one incentive toy comprises an acoustic device, the acoustic device being selected from a group consisting of a bi-directional siren, a bi-directional whistle, a uni-directional siren, and a uni-directional whistle.

9. The incentive inhaler device of claim 8, wherein the acoustic device is unidirectional and reversible attached such that in a first position sound is made upon inhalation and in a second position sound is made upon exhalation.

10. The incentive inhaler device of claim 1, wherein the valve is a one-way valve positioned within a conduit of the separator element that provides for an attachment of the incentive toy in sealable engagement with an interior wall of said conduit.

11. The incentive inhaler device of claim 10, wherein the conduit comprises at least three adaptor ends for connection of the respiration device, the connector and at least one incentive toy, and wherein at least one valve is positioned within the conduit in sealable engagement with the interior wall thereof at least one of said adaptor ends.

12. The incentive inhaler device of claim 11, wherein the one-way valve is positioned within the conduit in sealable engagement therewith and at an adaptor end that connects to the connector, such that a medicament can be drawn into the respiration device from the drug delivery device but not in an opposite direction.

13. The incentive inhaler device of claim 10, wherein the incentive toy is inhalation-driven, and the one-way valve is positioned within the conduit in sealable engagement therewith and at one end of said conduit that connects to said incentive toy, such that air can be drawn via said incentive toy and into the respiration device via the conduit but not in an opposite direction.

14. The incentive inhaler device of claim 10, wherein the incentive toy is exhalation-driven, and the one-way valve positioned within the conduit in sealable engagement therewith and at one end of said conduit that connects to said incentive toy, such that an exhaled air/medicament mixture can pass via said incentive toy from the respiration device but not in an opposite direction.

15. The incentive inhaler device of claim 10, further comprising at least one venturi comprising a frustoconical portion tapered at one end, said venturi being positioned:

(i) coaxially within the conduit such that a circumference of an outer wall of said venturi is in sealable engagement with a circumference of the interior wall of the conduit; and

(ii) sufficiently near to an end of said conduit that connects to the incentive toy such that a velocity of air is increased when it passes through said venturi thereby increasing a velocity of air passing from said venturi over or through said toy.

16. The incentive inhaler device of claim 10, further comprising a spacer unit positioned between the respiration device and the connector.

17. The incentive inhaler device of claim 1, wherein the separator element is positioned in sealable engagement with both the respiration device and the connector.

18. The incentive inhaler device of claim 17, wherein the connector comprises:

an aperture at one end to sealably-engage the drug delivery device thereby minimizing leakage of a medicament between the connector and the drug delivery device linked thereto; and

an end segment to releasably- and sealably-engage said connector to the separator element.

19. The incentive inhaler device of claim 18, wherein the end segment includes a snap-lock.

20. The incentive inhaler device of claim 1, further comprising a spacer unit positioned between the respiration device and the connector.

21. A connector for use with the incentive inhaler device of claim 1, comprising:

a drug delivery receiving means comprising an aperture at one end to sealably-engage the drug delivery device such that minimum leakage of a medicament occurs between the connector and the drug delivery device linked thereto; and

an end segment to releasably- and sealably-engage said connector to a respiration device with which said connector is associated in the incentive inhaler device.

22. The connector of claim 21, wherein the drug delivery receiving means is flexible in order to conform to fit a variety of drug delivery ports.

23. The incentive inhaler device of claim 1 wherein the separator element is connected to the respiration device.

24. The incentive inhaler device of claim 1 wherein the separator element is connected to the connector.

25. The incentive inhaler device of claim 1 wherein the respiration device is a mouthpiece or mask.

26. The incentive inhaler of claim 1 wherein the separator element directs inhaled air to said toy.

27. The incentive inhaler of claim 1 wherein the separator element directs exhaled air to said toy.

31. The incentive inhaler device of claim 23, wherein the incentive toy comprises an exhalation-driven whistle and an exhalation-driven spinning disc.

34. The method of claim 23 further comprising selecting an inhalable medicament from the group consisting of an anti-inflammatory compound, a natural steroid, a synthetic steroid, a bronchodilator, a vasodilator, a naturopathic medicine, a homeopathic medicine, an antihistamine, an antibiotic, a cough mixture, a tranquilizer, an anaesthetic, a therapeutic drug including at least one of nitrous oxide, oxygen, and air, an adrenergic receptor agonist, an adrenergic receptor antagonist, a beta-agonist, and a beta-blocker.

28. An incentive inhaler device for administering an anaesthetic, comprising:

a mask;

a drug delivery tube that is linkable to a drug delivery device such that during inspiration there is a main inspiration flow of anaesthetic from the drug delivery device to the mask via said drug delivery tube;

at least one incentive toy driven by exhaled air passing over said toy or through said toy wherein said toy has a visible characteristic or an audible characteristic; and

a separator element comprising a conduit, wherein said conduit comprises three adaptor ends that are connected separately to said mask, said drug delivery tube and said incentive toy, and wherein said conduit comprises a one-way valve in sealing engagement with an interior wall of an adaptor end juxtaposed to the incentive toy to prevent a flow of inhaled air from the incentive toy to the mask and to separate said toy from said main inspiration flow of anaesthetic.

29. The incentive inhaler device of claim 28, further comprising a second one-way valve in sealing engagement with an interior wall of an adaptor juxtaposed to the drug delivery tube to prevent flow of exhaled air to the drug delivery tube.

30. The incentive inhaler device of claim 28, further comprising at least one venturi comprising a frustoconical portion tapered at one end, said venturi being positioned:

(i) coaxially within the conduit such that a circumference of an outer wall of said venturi is in sealable engagement with a circumference of the interior wall of the adaptor end of the conduit juxtaposed the incentive toy; and

(ii) sufficiently near to the incentive toy such that a velocity of air passing through said venturi is increased thereby increasing a velocity of air passing from said venturi over or through said toy.

32. The incentive inhaler device of claim 28, further comprising a scavenger pipe in engagement with the exhalation-driven incentive toy, such that exhaled air passing via said incentive toy is collected in a scavenger system comprising the scavenger pipe.

33. A method of operating an incentive inhaler device to administer an inhalable medicament to a child, comprising:

(a) providing an incentive inhaler device comprising;

(i) an inhalation device comprising a respiration device and a connector that is linkable to a drug delivery device such that there is a main inspiration flow of a medicament from said drug delivery device into said respiration device via said connector during inspiration by a child;

(ii) at least one incentive toy coupled to the inhalation device, being driven by inhaled or exhaled air passing over said toy or through said toy, wherein said toy has a visible characteristic or an audible characteristic; and

(iii) at least one separator element positioned so as to separate said toy from said main inspiration flow of a medicament and provide a separate air flow passage over or through said toy from or to outside said main inspiration flow wherein said separator element includes an integer selected from the group consisting of;

a valve, a filter and a baffle;

(b) bringing the respiration device in contact with a child'"'"'s face; and

(c) causing a child to inhale through the respiration device or exhale into the respiration device thereby activating said toy.

35. A method of operating an incentive inhaler device to administer an anaesthetic to a child comprising:

(a) providing an incentive inhaler device comprising;

(i) a mask;

(ii) a drug delivery tube that is linkable to a drug delivery device such that during inspiration there is a main inspiration flow of anaesthetic from the drug delivery device to the mask via said drug delivery tube;

(iii) at least one incentive toy driven by exhaled air passing over said toy or through said toy, wherein said toy has a visible characteristic or an audible characteristic; and

(iv) a separator element comprising a conduit, wherein said conduit comprises three adaptor ends that are connected separately to said mask, said drug delivery tube and said incentive toy and wherein said conduit comprises a one-way valve in sealing engagement with an interior wall of adaptor end juxtaposed to said incentive toy to prevent a flow of inhaled air from the incentive toy to the mask and to separate said toy from said main inspiration flow of anaesthetic;

(b) bringing the mask in contact with a child'"'"'s face;

(c) causing said child to exhale into the mask thereby activating the incentive toy; and

(d) optionally, exhausting the exhaled air into a scavenger system.

36. An incentive inhaler device comprising:

(i) an inhalation device comprising a respiration device and a connector that is linkable to a drug delivery device such that there is a main inspiration flow of a medicament from said drug delivery device into said respiration device via said connector during inhalation by a subject through said respiration device;

(ii) two incentive toys coupled to the inhalation device, the toys having an audible characteristic or a visible characteristic, wherein said toys are driven by inhaled air and/or exhaled air passing over them or through them; and

(iii) a separator element consisting of a three-way conduit comprising;

(a) an adaptor end for operable attachment of the incentive toys to the inhalation device;

(b) a venturi comprising a frustoconical portion tapered at one end, said venturi being positioned;

(i) coaxially within the conduit such that a circumference of an outer wall of said venturi is in sealable engagement with a circumference of an interior wall of said separator element; and

(ii) sufficiently near to said adaptor end such that a velocity of air passing through said venturi is increased thereby increasing a velocity of air passing from said venturi over or through said incentive toys attached to said adaptor end; and

(c) a one-way valve in sealing engagement with an interior wall of an adaptor end juxtaposed said drug delivery device or said connector to ensure a directional flow of air, wherein said separator element is positioned so as to separate said toys from said main inspiration flow of a medicament.

37. The incentive inhaler device of claim 36 wherein the separator element is connected to the respiration device.

38. The incentive inhaler device of claim 36 wherein the separator element is connected to the connector.

39. The incentive inhaler device of claim 36 further comprising a spacer positioned between the respiration device and the connector.

40. The incentive inhaler device of claim 36 wherein the incentive toys consist of a whistle and a spinning disc.

41. The incentive inhaler device of claim 36 wherein the respiration device is a mouthpiece or mask.

42. A method of operating an incentive inhaler device for administering a medicament to a child comprising:

(a) providing an incentive inhaler device comprising;

(i) an inhalation device comprising a respiration device and a connector that is linkable to a drug delivery device such that there is a main inspiration flow of a medicament from said drug delivery device into said respiration device via said connector during inhalation by a child through said respiration device;

(ii) two incentive toys coupled to the inhalation device, the toys having an audible characteristic or a visible characteristic, wherein said toys are driven by inhaled air and/or exhaled air passing over them or through them;

(iii) a separator element consisting of a three-way conduit comprising;

(a) an adaptor end for operable attachment of the incentive toys to the inhalation device;

(b) a venturi comprising a frustoconical portion tapered at one end, said venturi being positioned;

(i) coaxially within said conduit such that a circumference of an outer wall of said venturi is in sealable engagement with a circumference of an interior wall of said separator element; and

(ii) sufficiently near to said adaptor end such that a velocity of air passing through said venturi is increased thereby increasing a velocity of air passing from said venturi over or through said incentive toys attached to said adaptor end; and

(c) a one-way valve in sealing engagement with an interior wall of an adaptor end juxtaposed said drug delivery device or said connector to ensure a directional flow of air, wherein said separator element is positioned so as to separate said toys from said main inspiration flow of a medicament;

(b) bringing the respiration device in contact with a child'"'"'s face; and

(c) causing said child to inhale and exhale into the respiration device thereby activating said toys.

43. The method of claim 42 further comprising selecting an inhalable medicament from the group consisting of an anti-inflammatory compound, a natural steroid, a synthetic steroid, a bronchodilator, a vasodilator, a naturopathic medicine, a homeopathic medicine, an antihistamine, an antibiotic, a cough mixture, a tranquilizer, an anaesthetic, a therapeutic drug including at least one of nitrous oxide, oxygen, and air, an adrenergic receptor agonist, an adrenergic receptor antagonist, a beta-agonist, and a beta-blocker.

44. An incentive inhaler device comprising:

(i) an inhalation device comprising a respiration device and a connector that is linkable to a drug delivery device such that there is a main inspiration flow of a medicament from said drug delivery device into said respiration device via said connector during inhalation by a subject through said respiration device;

(ii) a toy unit comprising two incentive toys coupled to said inhalation device wherein one toy has an audible characteristic activated by air passing over or through it and wherein one toy has a visible characteristic activated by air passing over or through it;

(iii) a separator element comprising a three-way conduit operably connected at one end to said respiration device and at another end to said connector, said conduit including an adaptor end for operable attachment of the toy unit to the inhalation device, said adaptor end including a one-way valve in sealing engagement with an interior wall of said adaptor end juxtaposed to the toy unit to ensure a directional flow of inhaled or exhaled air over or through said toy unit, said separator element positioned so as to separate said toy unit from said main inspiration flow of a medicament.

45. The incentive inhaler device of claim 44 wherein the toys are driven by exhaled air.

46. The incentive inhaler device of claim 44 wherein the toys are driven by inhaled air.

47. The incentive inhaler device of claim 44 wherein the separator element is connected to the respiration device.

48. The incentive inhaler device of claim 44 wherein the separator element is connected to the connector.

49. The incentive inhaler device of claim 44 further comprising a spacer positioned between the respiration device and the connector.

50. The incentive inhaler device according to claim 44 further comprising at least one venturi comprising a frustoconical portion tapered at one end, said venturi being positioned:

(i) coaxially within the conduit such that a circumference of an outer wall of said venturi is in sealable engagement with a circumference of an interior wall of said conduit; and

(ii) sufficiently near to said adaptor end of said conduit such that a velocity of air passing through said venturi is increased thereby increasing a velocity of air passing from said venturi over or through said incentive toys attached to said adaptor end.

51. The incentive inhaler device of claim 44 wherein the incentive toys consist of a whistle and a spinning disc.

52. The incentive inhaler device of claim 44 wherein the respiration device is a mouthpiece or mask.

53. A method of operating an incentive inhaler device for administering a medicament to a child comprising:

(a) providing an incentive inhaler device comprising;

(i) an inhalation device comprising a respiration device and a connector that is linkable to a drug delivery device such that there is a main inspiration flow of a medicament from said drug delivery device into said respiration device via said connector during inhalation by a child through said respiration device;

(ii) a toy unit comprising two incentive toys coupled to said inhalation device wherein one toy has an audible characteristic activated by air passing over or through it and wherein one toy has a visible characteristic activated by air passing over or through it;

(iii) a separator element comprising a three-way conduit operably connected at one end to said respiration device and at another end to said connector, said conduit including an adaptor end for operable attachment of the toy unit to the inhalation device, said adaptor end including a one-way valve in sealing engagement with an interior wall of said adaptor end juxtaposed to the toy unit to ensure a directional flow of inhaled or exhaled air over or through said toy unit, said separator element positioned so as to separate said toy unit from said main inspiration flow of a medicament;

(b) bringing the respiration device in contact with a child'"'"'s face; and

(c) causing a child to inhale or exhale to thereby activate said toys.

54. The method of claim 53 further comprising selecting an inhalable medicament from the group consisting of an anti-inflammatory compound, a natural steroid, a synthetic steroid, a bronchodilator, a vasodilator, a naturopathic medicine, a homeopathic medicine, an antihistamine, an antibiotic, a cough mixture, a tranquilizer, an anaesthetic, a therapeutic drug including at least one of nitrous oxide, oxygen, and air, an adrenergic receptor agonist, an adrenergic receptor antagonist, a beta-agonist, and a beta-blocker.

55. A separator element for connecting an incentive toy to an inhalation device having a respiration device and a connector that is linkable to a drug delivery device such that there is a main inspiration flow of a medicament from said drug delivery device into said respiration device via said connector during inspiration by a subject through said respiration device, the toy being driven by inhaled or exhaled air passing over said toy or through said toy, said separator element comprising a three-way conduit having a first end for connection to said respiration device, a second end for connection to said connector and an adaptor end for connection to said incentive toy, said separator element including a one-way valve in sealable engagement with an interior wall thereof to ensure a directional flow of inhaled or exhaled air over or through said toy, said separator element separating said toy from said main inspiration flow of a medicament.

56. The separator element as claimed in claim 55 wherein said one-way valve is position in said adaptor in sealing engagement with an interior wall of said adaptor end.