System & method for application of medicament into the nasal passage

• US 20020017294A1
• Filed: 08/09/2001
• Published: 02/14/2002
• Est. Priority Date: 12/14/1999
• Status: Active Grant

• Current Assignee: Maej, LLC
• Original Assignee: Medical Instill Technologies Inc.
• Inventors: Py, Daniel
• Granted Patent: US 6,505,622 B2
• Time in Patent Office: Days
• US Class Current: 128/200.23
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/0025 with caps
• CPC Class Codes: A61M 15/0026 Hinged caps
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 2205/073 Syringe, piston type
• CPC Class Codes: A61M 2206/16 Rotating swirling helical flow, e.g. by tangential inflows
• CPC Class Codes: B05B 1/341 before discharging the liquid or other fluent material, e.g. in a swirl chamber upstream the spray outlet
• CPC Class Codes: B05B 1/3436 the interface being a plane perpendicular to the outlet axis
• CPC Class Codes: B05B 11/0038 Inner container disposed in an outer shell or outer casing
• CPC Class Codes: B05B 11/007 being opened by deformation of a sealing element made of resiliently deformable material, e.g. flaps, skirts, duck-bill valves
• CPC Class Codes: B05B 11/0072 A valve member forming part of an outlet opening
• CPC Class Codes: B05B 11/0075 Two outlet valves being placed in a delivery conduit, one downstream the other
• CPC Class Codes: B05B 11/026 Membranes separating the content remaining in the container from the atmospheric air to compensate underpressure inside the container
• CPC Class Codes: B05B 11/1001 Piston pumps B05B11/1087, B05B11/1088, B05B11/109 take precedence
• CPC Class Codes: B05B 11/1011 without substantial movement of the nozzle in the direction of the pressure stroke
• CPC Class Codes: B05B 11/1066 Pump inlet valves B05B11/1018, B05B11/1019, B05B11/1064 take precedence
• CPC Class Codes: B05B 11/1074 located outside pump chambers
• CPC Class Codes: B05B 11/1076 Traction springs, e.g. stretchable sleeve
• CPC Class Codes: B05B 11/1077 characterised by a particular shape or material B05B11/1076 takes precedence
• CPC Class Codes: B05B 11/109 : the dispensing stroke being affected by the stored energy of a spring B05B11/1088 takes precedence
• CPC Class Codes: B05B 11/1092 : automatically released from a loaded state at the end of the loading stroke
• CPC Class Codes: B05B 11/1095 : with movable suction side

Abstract

A pump-type dispenser for dispensing predetermined doses of medicament in droplets or in spray form to the nasal area incorporates a rigid vial for medicament, an expandable pouch located within the rigid vial, a nasal screen, a one-way actuation mechanism, a one-way valve mechanism in the nozzle area and a spring element, both the valve mechanism and the spring element being formed as integral portions of the pump body. The nasal screen aligns the dispenser nozzle with the nasal passage and also allows the user to discreetly hide the nasal area from public view. The one-way valve mechanism in the nozzle area ensures a one-way movement of medicament from the dispenser, thereby preserving substantially perfect sterility of the medicament in the dispenser regardless of the environment surrounding the dispenser, without requiring the use of preservatives. The one-way actuation mechanism enables the user to load and dispense a uniform quantity of medicament with a uniform actuation force and speed via a single continuous motion of the actuation mechanism upon application of a very small force on the actuation trigger mechanism by the user. By preventing the pump mechanism from being left in a loaded state for a prolonged period of time, the one-way actuation mechanism prevents the spring element from experiencing the “fatigue” phenomenon. The rigid vial/expandable-pouch combination facilitates improved long term use, as well as uniformity of dosage independent of the pump orientation.

Claims

1. A dispensing system for delivery of medicament to a nasal passage, which comprises:

a vial for holding a volume of medicament;

a pump having an outlet in a nozzle portion and an elastic, deformable body portion connected to said nozzle portion, said body portion containing a piston mechanism and a dosage cavity of a predetermined volume for collecting 8 medicament from said vial, said nozzle portion having a rigid shaft received therein and interfacing said outlet to form a first normally-closed valve;

a housing retaining said vial and said pump, said housing exposing said outlet, and said housing having a guide element for aligning, when in a first position, said outlet with said nasal passage and screening said nasal passage from view;

a trigger operationally coupled to said housing for actuating, by a single actuating motion of said trigger, said dispensing system to sequentially fill said dosage cavity with medicament from said vial and subsequently discharge said medicament from said dosage cavity;

a lever operationally coupled to said trigger and releasably engaging said deformable body portion when said body portion is in ambient position, said lever being movable to a first non-ambient position in concert with a first phase of said actuating motion of said trigger and deforming at least a portion of said deformable body portion to cause flow of medicament from said vial to said dosage cavity to fill said dosage cavity; and

a release arm internally positioned in the housing to oppose said lever at said first non-ambient position so as to disengage said lever from said deformable body portion upon continuation of said actuating motion into a second phase, wherein said elastic, deformable body portion returns to said ambient position upon disengagement from said lever to pressurize medicament in said dosage cavity and discharge said medicament through said outlet of said nozzle portion.

2. The system according to claim 1, wherein said elastic, deformable body portion comprises one of a bellows-shaped portion and a dome-shaped portion, and wherein said rigid shaft and interior of said nozzle portion define a swirling chamber for said medicament prior to expulsion via said outlet, and wherein said piston mechanism is operatively coupled to said deformable body portion to move along longitudinal axis of the pump in connection with deformation of the deformable body portion along its longitudinal axis, displacement of said piston mechanism corresponding to displacement of the lever between said ambient position and said first non-ambient position.

3. The system according to claim 2, wherein said guide element is pivotably coupled to said housing, said guide element, when in a second position, substantially covering said outlet, and wherein said nozzle portion has a wall thickness which decreases from a first point along a direction of elongated axis of symmetry of said nozzle portion toward a tip of the nozzle portion.

4. The system according to claim 3, wherein said trigger is actuated in the direction perpendicular to the longitudinal axis of said housing.

5. The system according to claim 4, wherein said trigger and said lever are integrally formed.

6. The system according to claim 5, wherein said medicament in said swirling chamber is expelled via said first normally-closed valve upon reaching a threshold pressure sufficient to radially deform said nozzle portion to open said first normally-closed valve.

7. The system according to claim 6, wherein said one of said bellows-shaped portion and said dome-shaped portion is made of thermoplastic material.

8. The system according to claim 7, wherein said housing is substantially rigid, said housing preventing deformation of said nozzle portion along said axial direction during expulsion of said medicament from said swirling chamber via said outlet.

9. The system according to claim 2, wherein said nozzle portion further comprises a fluid channel defining a portion of a fluid communication path between said dosage cavity and said swirling chamber, said channel inducing swirling action of medicament channeled to said swirling chamber.

10. The system according to claim 9, wherein said deformable body portion comprises at least one bellows-shaped portion made of thermoplastic material.

11. The system according to claim 10, wherein said guide element is pivotably coupled to said housing, said guide element, when in a second position, substantially covering said outlet.

12. The system according to claim 11, wherein said trigger is actuated in the direction perpendicular to the longitudinal axis of said housing.

13. The system according to claim 12, wherein said trigger and said lever are integrally formed.

14. The system according to claim 13, wherein said medicament in said swirling chamber is expelled via said first normally-closed valve upon reaching a threshold pressure sufficient to radially deform said nozzle portion to open said first normally-closed valve.

15. The system according to claim 14, wherein said bellows-shaped portion is made of Kraton™

.

16. The system according to claim 15, wherein said housing is substantially rigid, said housing preventing deformation of said nozzle portion along said axial direction during expulsion of said medicament from said swirling chamber via said outlet.

17. The system according to claim 9, wherein said fluid channel comprises a vertical portion extending along the radial edge of said nozzle portion.

18. The system according to claim 17, wherein said deformable body portion comprises at least one bellows-shaped portion made of thermoplastic material.

19. The system according to claim 18, wherein said guide element is pivotably coupled to said housing, said guide element, when in a second position, substantially covering said outlet.

20. The system according to claim 19, wherein said trigger is actuated in the direction perpendicular to the longitudinal axis of said housing.

21. The system according to claim 20, wherein said trigger and said lever are integrally formed.

22. The system according to claim 21, wherein said medicament in said swirling chamber is expelled via said first normally-closed valve upon reaching a threshold pressure sufficient to radially deform said nozzle portion to open said first normally-closed valve.

23. The system according to claim 22, wherein said bellows-shaped portion is made of Kraton™

.

24. The system according to claim 23, wherein said housing is substantially rigid, said housing preventing deformation of said nozzle portion and said fluid channel along said axial direction during expulsion of said medicament from said swirling chamber via said outlet.

25. The system according to claim 1, wherein said vial has an opening at a neck region of said vial, which system further comprises:

a rigid ring for operatively engaging an interior surface of said neck region of said vial; and

a mechanical plug for operatively and simultaneously engaging an exterior surface of said neck region of said vial and said interior annular surface of said rigid ring, said mechanical plug having a leg extending substantially perpendicular to a bottom surface of the mechanical plug for operatively engaging a bottom surface of said rigid ring;

whereby said mechanical plug and said rigid ring provide a mechanical seal of said vial opening by simultaneously engaging at least a portion of said neck region of said vial.

26. The system according to claim 25, wherein said mechanical plug and said rigid ring provide a horizontal compression of said neck region of said vial to achieve a seal along the vertical dimension of the neck region.

27. The system according to claim 26, wherein said mechanical plug and said rigid ring provide a vertical compression of said neck region of said vial to achieve a seal along the horizontal dimension of the neck region.

28. The system according to claim 3, wherein said vial has an opening at a neck region of said vial, which system further comprises:

a rigid ring for operatively engaging an interior surface of said neck region of said vial; and

a mechanical plug for operatively and simultaneously engaging an exterior surface of said neck region of said vial and said interior annular surface of said rigid ring, said mechanical plug having a leg extending substantially perpendicular to a bottom surface of the mechanical plug for operatively engaging a bottom surface of said rigid ring;

whereby said mechanical plug and said rigid ring provide a mechanical seal of said vial opening by simultaneously engaging at least a portion of said neck region of said vial.

29. The system according to claim 9, wherein said vial has an opening at a neck region of said vial, which system further comprises:

a rigid ring for operatively engaging an interior surface of said neck region of said vial; and

a mechanical plug for operatively and simultaneously engaging an exterior surface of said neck region of said vial and said interior annular surface of said rigid ring, said mechanical plug having a leg extending substantially perpendicular to a bottom surface of the mechanical plug for operatively engaging a bottom surface of said rigid ring;

whereby said mechanical plug and said rigid ring provide a mechanical seal of said vial opening by simultaneously engaging at least a portion of said neck region of said vial.

30. The system according to claim 1, wherein said vial has an opening at a neck region of said vial, which system further comprises:

a mechanical plug; and

a crimping element repositionably coupled to the mechanical plug via a flange;

wherein the mechanical plug and the crimping element operatively interact with the neck region to seal the vial.

31. The system according to claim 30, wherein:

in a first configuration, the crimping element is coupled to the mechanical plug, and the mechanical plug detachably engages with an interior surface of the neck region of the vial to removably seal the opening of the vial;

and wherein, in a second configuration, the mechanical plug engages the interior surface of the neck region of the vial, and the crimping element is repositioned relative to the mechanical plug and engages an exterior surface of the neck region of the vial to seal the opening of the vial in conjunction with the mechanical plug.

32. The system according to claim 3, wherein said vial has an opening at a neck region of said vial, which system further comprises:

a mechanical plug; and

a crimping element repositionably coupled to the mechanical plug via a flange;

wherein the mechanical plug and the crimping element operatively interact with the neck region to seal the vial.

33. The system according to claim 32, wherein:

in a first configuration, the crimping element is coupled to the mechanical plug, and the mechanical plug detachably engages with an interior surface of the neck region of the vial to removably seal the opening of the vial;

and wherein, in a second configuration, the mechanical plug engages the interior surface of the neck region of the vial, and the crimping element is repositioned relative to the mechanical plug and engages an exterior surface of the neck region of the vial to seal the opening of the vial in conjunction with the mechanical plug.

34. The system according to claim 9, wherein said vial has an opening at a neck region of said vial, which system further comprises:

a mechanical plug; and

a crimping element repositionably coupled to the mechanical plug via a flange;

wherein the mechanical plug and the crimping element operatively interact with the neck region to seal the vial.

35. The system according to claim 34, wherein:

in a first configuration, the crimping element is coupled to the mechanical plug, and the mechanical plug detachably engages with an interior surface of the neck region of the vial to removably seal the opening of the vial;

and wherein, in a second configuration, the mechanical plug engages the interior surface of the neck region of the vial, and the crimping element is repositioned relative to the mechanical plug and engages an exterior surface of the neck region of the vial to seal the opening of the vial in conjunction with the mechanical plug.

36. The system according to claim 1, wherein said deformable body portion comprises an elastomeric material providing spring action which enables said deformable body portion to return to said ambient position from said first non-ambient position, and wherein said rigid shaft and interior of said nozzle portion define a swirling chamber for said medicament prior to expulsion via said outlet.

37. The system according to claim 36, wherein said deformable body portion comprises one of a bellows-shaped portion and a dome-shaped portion.

38. The system according to claim 36, wherein said deformable body portion is made of a thermoplastic material.

39. The system according to claim 36, wherein said nozzle portion further comprises at least one fluid channel defining a portion of a fluid communication path between said dosage cavity and said swirling chamber, said channel inducing swirling action of medicament channeled to said swirling chamber.

40. The system according to claim 39, wherein said fluid channel comprises a vertical portion extending along the radial edge of said nozzle portion.

41. The system according to claim 40, wherein said fluid channel further comprises horizontal portion extending from said vertical portion towards the radial center of said nozzle portion to connect with said swirling chamber.

42. The system according to claim 41, wherein said nozzle portion has a plurality of fluid channels each having a vertical portion and a horizontal portion, each of said horizontal portions being connected to said swirling chamber.

43. The system according to claim 42, wherein each horizontal portion of said fluid channels has a width that decreases in the direction from the radial edge of the nozzle portion towards said swirling chamber.

44. The system according to claim 42, wherein said swirling chamber is substantially circular and said horizontal portions of said fluid channels are connected to said swirling chamber tangentially.

45. The system according to claim 44, wherein a floor of a portion of said swirling chamber at which any one said horizontal portions converge with said swirling chamber is higher than a floor of the converging horizontal portion.

50. The dispensing system according to claim 49, wherein said body portion further contains a pump sleeve, said piston being at least partially and slidably positioned within said pump sleeve, and wherein said dispensing system further comprises at least one O-shaped ring on annular portion of said piston and slidably engaging said pump sleeve to provide a fluid-tight seal.

51. The dispensing system according to claim 49, wherein said vial portion has an opening region for facilitating medicament filling, which further comprises:

a mechanical plug for sealing said opening region of said vial portion, said mechanical plug having a U-shaped cross-section along its annular portion, said mechanical plug being adapted to securely engage said opening region by sliding over said opening region and radially clasping said opening region with said U-shaped annular portion, wherein said air-flow channel extends through said mechanical plug.

52. The dispensing system according to claim 49, wherein said vial portion is made of a rigid material, and wherein said elastic pouch is in collapsed condition when the vial is filled with medicament, and wherein said elastic pouch expands as the medicament contained in the vial is dispensed via said outlet.

46. A dispensing system for the delivery of medicament to nasal passage, which comprises:

a vial for holding a volume of medicament;

a pump having an outlet in a nozzle portion, an elastic, deformable body portion connected to said nozzle portion and containing a piston mechanism and a dosage cavity of a predetermined volume for collecting medicament from said vial, and a fluid inlet orifice in fluid communication with said vial and said dosage cavity, said piston mechanism being operatively coupled to said deformable body portion to move along longitudinal axis of the pump in connection with deformation of the deformable body portion along its longitudinal axis, said nozzle portion having a wall thickness which decreases from a first point along a direction of elongated axis of symmetry of said nozzle portion toward a tip of the nozzle portion, and said nozzle portion having a rigid shaft received therein and interfacing said outlet to form a first normally-closed valve, said rigid shaft and interior of said nozzle portion defining a swirling chamber for said medicament prior to expulsion via said outlet;

a housing retaining said vial and said pump, said housing exposing said outlet, and said housing having a guide element for aligning, when in a first position, said outlet with said nasal passage and screening said nasal passage from view;

a trigger operationally coupled to said housing for actuating, by a single actuating motion of said trigger, said dispensing system to sequentially fill said dosage cavity with medicament from said vial and subsequently discharge said medicament from said dosage cavity;

a lever operationally coupled to said trigger and releasably engaging said deformable body portion when said body portion is in ambient position, said lever being movable to a first non-ambient position in concert with a first phase of said actuating motion of said trigger and deforming at least a portion of said deformable body portion, and in concert moving said piston mechanism, along the longitudinal axis towards the posterior end of said housing, displacement of said piston mechanism corresponding to displacement of the lever between said ambient position and said first non-ambient position causing flow of medicament from said vial to said dosage cavity to fill said dosage cavity; and

a release arm internally positioned in the housing to oppose said lever at said first non-ambient position so as to disengage said lever from said deformable body portion upon continuation of said actuating motion into a second phase, wherein said deformable body portion returns to said ambient position upon disengagement from said lever and said piston mechanism moves in concert with said deformable body portion towards said nozzle portion to pressurize medicament in said dosage cavity and discharge said medicament through said outlet of said nozzle portion.

47. A method of delivering medicament to nasal passage by means of a medicament dispensing system having a medicament vial;

a pump with an outlet defined by a first normally-closed valve, a swirling chamber in a nozzle portion, and an elastic, deformable body portion connected to said nozzle portion, said body portion containing a piston mechanism and a dosage cavity of a predetermined volume for collecting medicament from said vial, and a fluid channel between said dosage cavity and said swirling chamber;

a housing retaining said vial and said pump;

a trigger operationally coupled to said housing for actuating said dispensing system;

a lever operationally coupled to said trigger and releasably engaging said deformable body portion; and

a release arm internally positioned in the housing;

which method comprises;

channeling medicament from said vial to said dosage cavity by actuating said trigger through a first phase of a single continuous actuating motion whereby said lever is moved from an ambient position to a first non-ambient position in concert with said first phase of said single continuous actuating motion and deforms at least a portion of said elastic, deformable body portion;

actuating said trigger through a second phase of said single continuous actuating motion whereby said lever is opposed by said release arm at said first non-ambient position so as to disengage said lever from said deformable body portion;

pressurizing said medicament in said dosage cavity to create medicament flow to said swirling chamber via said fluid channel by means of initiating a return movement of said elastic, deformable body portion to said ambient position upon disengagement from said lever;

generating swirling of said medicament within said swirling chamber by means of tangential connection of said fluid channel to said swirling chamber; and

discharging said medicament from said swirling chamber through said first normally-closed valve by means of completing said return movement of said deformable body portion to said ambient position and pressurizing said medicament to reach a threshold pressure sufficient to open said first normally-closed valve.

48. A pump mechanism for use in a medicament-dispensing system having a vial for holding a volume of medicament, a deformable body portion for providing spring action to said pump mechanism, and a nozzle portion through which said medicament is emitted, which comprises:

a pump sleeve positioned within said deformable body portion, said sleeve having a dosage cavity of a predetermined volume for collecting medicament from said vial, said dosage cavity being connected to said nozzle portion, said sleeve also having a fluid-inlet orifice for channeling said medicament into said dosage cavity; and

a piston at least partially and slidably positioned within said pump sleeve for emitting said medicament from said dosage cavity via said nozzle portion, said piston being operationally coupled to said deformable body portion; and

at least one O-shaped ring on annular portion of said piston and slidably engaging said pump sleeve, wherein said O-shaped ring provides a fluid-tight seal.

49. A dispensing system for delivery of medicament, which comprises:

a vial portion for holding a volume of medicament;

a pump having an outlet in a nozzle portion and an elastic, deformable body portion connected to said nozzle portion, said body portion containing a piston mechanism and a dosage cavity of a predetermined volume for collecting medicament from said vial, said nozzle portion having a rigid shaft received therein and interfacing said outlet to form a normally-closed valve; and

an elastic pouch positioned within said vial, interior of said elastic pouch containing varying amounts of air, said air in said elastic pouch being in communication with external ambient air via an air-flow channel, and the volume of said elastic pouch being variably altered as a function of the volume of medicament contained in the vial.