A NASAL DELIVERY SYSTEM

Abstract

A nasal delivery system comprising a nasal insertion tube and a fluid medium located in communication with the nasal insertion tube. The nasal insertion tube comprises a tubular wall forming an internal flow path from an inlet to an outlet. The outlet is configured to be arranged in a nostril of a person to thereby facilitate an upstream flow of air in a first flow path from an ambient space through the internal flow path to the respiratory tract of the person during inhaling and a downstream flow of air in a second flow path from the respiratory tract of the person outside the internal flow path to the ambient space during exhaling. The system further comprises a flow diverter structure configured for providing a first ratio between the flow resistance in the first flow path and the flow resistance in the second flow path during upstream flow and for providing a second ratio between the flow resistance in the first flow path and the flow resistance in the second flow path during downstream flow, where the second ratio is equal to or higher than the first ratio.

Claims

1.-23. (canceled)

24. A nasal delivery system comprising a nasal insertion tube and a fluid medium located in communication with the nasal insertion tube, the nasal insertion tube comprising a tubular wall forming an internal flow path from an inlet to an outlet, wherein the outlet is configured to be arranged in a nostril of a person to thereby facilitate an upstream flow of air in a first flow path from an ambient space through the internal flow path to the respiratory tract of the person during inhaling and a downstream flow of air in a second flow path from the respiratory tract of the person outside the internal flow path to the ambient space during exhaling, the system further comprising a flow diverter structure configured for providing a first ratio between the flow resistance in the first flow path and the flow resistance in the second flow path during upstream flow and for providing a second ratio between the flow resistance in the first flow path and the flow resistance in the second flow path during downstream flow, where the second ratio is equal to or higher than the first ratio.

25. The nasal delivery system according to claim 24, further comprising a container containing the fluid medium, and an entrance between the inlet and outlet, the entrance being in fluid communication with the container for establishing a fluid flow from the fluid container to the internal flow path.

26. The system according to claim 25, wherein the container is reversibly attachable to the nasal insertion tube.

27. The nasal delivery system according to claim 24, where the flow diverter structure is configured to provide a first flow resistance in the second flow path during exhaling and a second, increased, flow resistance in the second flow path during inhaling.

28. The nasal delivery system according to claim 24, where the flow diverter structure is configured to provide a first flow resistance in the first flow path during inhaling and a second, increased, flow resistance in the first flow path during exhaling.

29. The nasal delivery system according to claim 24, where the flow diverter structure is arranged at the outer surface of the tubular wall.

30. The system according to claim 24, wherein the flow diversion structure comprises a collar of an elastically deformable material arranged about the tubular wall and being configured to expand and contract by a change in pressure at the outer surface on opposite sides of the collar or by airflow in the second flow path.

31. The system according to claim 30, wherein the collar expands radially away from the tubular wall upon airflow towards the inlet.

32. The system according to claim 24, wherein the nasal insertion tube forms a U-shape whereby the flow path forms a first flow section from the inlet to one end of an intermediate flow section and a second flow section extending essentially parallel to the first flow section from another end of the intermediate flow section to the outlet, the intermediate flow section extending transverse to the first and second flow sections and forming the entrance.

33. The system according to claim 24, further comprising a flow control structure configured to control at least one of an air flow in the internal flow path or a flow of the fluid medium into the internal flow path, the control structure comprising a processor configured to control the flow based on a control signal.

34. The system according to claim 33, wherein the electrical signal is generated by a timer or by a sensor capable of sensing a bio-signal from a person.

35. The system according to claim 33, further comprising an actuator arranged to move the flow diverter structure.

36. The system according to claim 35, wherein the actuator moves the flow diverter structure in response to commands from the processor.

37. The system according to claim 24, further comprising a breathing sensor configured to determine a flow in the internal flow path.

38. The system according to claim 37, wherein the flow is determined by measuring an electrical signal generated by the flow.

39. The system according to claim 37, wherein the breathing sensor comprises at least one magnet movably arranged in the nasal insertion tube.

40. The system according to claim 39, wherein the breathing sensor further comprises a coil arranged around the nasal insertion tube.

41. The system according to claim 37, wherein the breathing sensor comprises at least three elongated metal elements extending substantially parallel from a carrier, where two of the at least three metal elements are movably arranged to allow bending hereof.

42. The system according to claim 41, wherein the electrical signal generated by the flow is caused by contact between two of the at least three metal elements.

43. The system according to claim 42, wherein the breathing sensor is further configured to determine a direction of the flow based on the contact between two of the at least three metal elements.

44. A method of delivering a fluid medium in a nostril of a person by use of a system according to claim 24, the method comprising the step of inserting the nasal insertion tube in the nostril such that the outlet is arranged in the nostril, establishing an upstream flow of air in the first flow path by inhaling and thereby establishing a fluid flow of the fluid medium to the flow path, establishing a downstream fluid flow in the second flow path by exhaling and moving the flow diverter structure to increase the ratio between the flow resistance in the first flow path and the flow resistance in the second flow path.

45. The method according to claim 44, wherein the flow diverter structure is moved by use of the downstream fluid flow.

46. The method according to claim 44, wherein the flow diverter structure is moved by use of an actuator.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0057] Embodiments of the invention will now be further described with reference to the drawings, in which:

[0058] FIG. 1 illustrates a nasal delivery system according to the invention;

[0059] FIGS. 2A-2C illustrate the nasal delivery system in FIG. 1 when inserted into nostrils of a person;

[0060] FIGS. 3A-3C illustrate an embodiment of a nasal delivery system;

[0061] FIGS. 4-9 illustrate different flow situations obtained with a nasal delivery system according to the invention;

[0062] FIG. 10 illustrates an embodiment with multiple insertion tubes;

[0063] FIGS. 11-12 illustrate an embodiment with a container attached to a mounting surface;

[0064] FIG. 13 illustrates an embodiment with a box inserted between the insertion tube and the container;

[0065] FIG. 14 illustrates an embodiment where the box is utilised for connection of an external container;

[0066] FIG. 15 illustrates an embodiment of a nasal delivery system with an electrical sensor;

[0067] FIGS. 16-17 illustrate an embodiment where the exhalation is through an inner tube in the internal flow path;

[0068] FIGS. 18A and 18B illustrate an embodiment with a movable closing member;

[0069] FIG. 19 illustrates an embodiment coupled to an oxygen breathing apparatus;

[0070] FIGS. 20-23 illustrate embodiments comprising one more magnets;

[0071] FIG. 24 illustrates an embodiment comprising a sensor;

[0072] FIG. 25 illustrates details of the sensor illustrated in FIG. 24;

[0073] FIG. 26 illustrates an embodiment with a container and a sensor; and

[0074] FIG. 27 illustrates different views of the embodiment illustrated in FIG. 26.

DETAILED DESCRIPTION OF THE DRAWINGS

[0075] It should be understood that the detailed description and specific examples, while indicating embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.

[0076] FIG. 1 illustrates a nasal delivery system 1 comprising a nasal insertion tube 2 and a container 3. The container forms space for a fluid medium, e.g. a drug solution, and it is fixed to an outer surface of the insertion tube 2 such that the container and the tube forms one integrated component. In one embodiment, the container is releasablely attached to allow replacement of an empty container with a new container, and in another embodiment, the container is non-replaceable and the integrated component is to be disposed when the container is empty.

[0077] The nasal insertion tube comprises a tubular wall 4 forming an internal flow path from an inlet 5 to an outlet 6. Between the inlet and the outlet, the insertion tube comprises an entrance 7. The entrance allows the fluid medium from the container to enter the internal flow path.

[0078] In the illustrated embodiment, the nasal insertion tube is U-shaped and forms first and second legs 9, 10 connected by an intermediate leg 11. During use, the nasal insertion tube is inserted into the nostrils in the direction indicated by the arrow 8 such that each nostril receives one of the two legs 9, 10.

[0079] When the nasal insertion tube 2 is in place, the person can inhale and thereby establish an upstream flow of air through a first flow path. The first flow path extends from ambient space 12 through the internal flow path to the respiratory tract of the person.

[0080] The person can exhale and establish a downstream flow of air through a second flow path extending from the respiratory tract of the person along an outer surface of the tubular wall. Due to the downstream flow, the flow diverter structure 13 at the outer surface 14 folds down and blocks the internal flow path 15. Accordingly, the flow diverter structure provides a first flow resistance in the second flow path during exhaling and a second, increased, flow resistance in the second flow path during inhaling.

[0081] FIG. 2 illustrates the nasal delivery system 1 inserted in the nostrils of a person.

[0082] FIG. 3 illustrates embodiments of the system. Illustration A shows one leg-part 9 of a nasal insertion tube with rings 16 of silicone or similar soft elastically rubber etc. The rings facilitate retaining of the nasal insertion tube in the nostril of a person.

[0083] Illustration B shows another embodiment where the rings of silicone are replaced by vanes 16 extending outwards from the leg-part 9 of the nasal insertion tube. The vanes are complemented by a holding member 17 fixed to the radial outer ends of each vane and facilitating compression of the vanes by the user gripping the leg-part and the holding member 17 between the thumb and forefinger. In illustration B, the holding member 17 and the vanes are compressed and the system is ready for insertion. In illustration C, the holding member is released and by the elasticity of the vanes, the system expands and thereby facilitates retention in the nostril of the person.

[0084] FIG. 4A illustrates with arrows, an upstream flow of air in a first flow path from an ambient space 12 through the internal flow path to the respiratory tract 18 of the person during inhaling. In the upstream flow, the flow diverter structure 13 folds out and guides the air through the internal flow path. Accordingly, the flow resistance in the first flow path is low which triggers a relatively large flow through the internal flow path.

[0085] FIG. 4B illustrates the version of FIG. 3, illustration B, C, including elastic vanes 16 and holding means for insertion into both nostrils of a person. Due to the elasticity, the holding means and the insertion tube expand the nostrils and can reduce snoring.

[0086] FIG. 5 illustrates schematically two tubes 2 in a mirrored mutual position. In this embodiment the nasal insertion tube forms a double tube with an additional flow path. As illustrated, each section of the flow path extends in parallel with the same section of the additional flow path. The two tubes of the double tube are joined e.g. by use of a resilient rubber of silicone connector (not illustrated).

[0087] In use, the outlet 6 of the flow path is placed in one nostril and the outlet 6 of the additional flow path is placed in the other nostril. The advantage of this embodiment is, that the breathing is allowed to follow a natural cycle in which one nostril is dominant for a few hours after which the other nostril takes over, vice versa. The double tube enables a more stable and homogenous intake of the fluid medium.

[0088] FIGS. 6-7 illustrate an embodiment where the flow diverter structure 13 is in the form of a movable valve element.

[0089] FIG. 6 illustrates the upstream flow of air, indicated by the arrow 8. The flow diverter structure 13 is moved to a position where it seals between the outer surface of the tubular wall 4 and the inner wall of the nostril into which the left leg is inserted. The flow diverter structure therefore blocks a flow between the outer wall and the wall of the nostril and thereby facilitates a flow in the first flow path during inhaling.

[0090] FIG. 7 illustrates that the flow diverter structure 13 forms an open valve during exhaling. The downstream flow of air is allowed to pass the insertion tube between the outer wall of the tube and the inner wall of the nostril, and there is no motivation for the air to flow through the internal flow path.

[0091] FIGS. 8-9 illustrate another embodiment where the flow diverter structure is arranged in another position relative to the inlet. The flow diverter structure is arranged such that a downstream flow of air reaches the inlet before reaching the flow diverter structure. In this way, the inhaling does not provide a flow through the internal flow path. In FIG. 8, the valve is open and in FIG. 9, the valve is closed thereby the air flow is forced through the internal flow path. This embodiment may be relevant in combination with drugs which must be released during exhaling.

[0092] FIG. 10A illustrates a side view of an alternative embodiment of the delivery system. The delivery system comprises three joined insertion tubes. There are therefore three internal flow paths in which air can flow. FIG. 10B illustrates three flow diverters 19 corresponding to each of the three insertion tubes to improve the air intake in the internal flow path.

[0093] To facilitate manufacturing, the U-shaped tubes and the container with the fluid medium, e.g. a liquid oil or medicine, is divided into two separate units 20, 21, as illustrated in FIG. 11. They may be assembled during manufacturing, or they may be delivered separately to be assembled by the user.

[0094] The figure shows the U-shaped tube which is made with a mounting surface 22 where the container 20 can be attached.

[0095] FIG. 12 illustrates an enlarged view of the mounting surface including a plurality of small pointed tubes 23. When the container 20 is pressed against the mounting surface 22 a foil layer of the container 20 is perforated and the fluid medium will flow through the pointed tubes 23 thereby constituting the entrance.

[0096] FIG. 13 illustrates an attachment box 24. The box may be configured for transport or to convert the content of the container to facilitate absorption in the nasal cavity. The box can be fitted to the mounting surface in the same way as the above described container 20. The box may have different functions. It may e.g. incorporate electrical control means, e.g. a processor and an electrically controlled valve for controlling release of the fluid medium e.g. based on a sensed bio-signal or based on temperature, or based on a clock/timer.

[0097] FIG. 14 illustrates a box 25 having the function of connecting a distal container 26 to the insertion tube via a connection pipe 27. This may allow placement of the container e.g. on the chest or on a table next to the bed.

[0098] The system may comprise a flow control structure including a sensor, e.g. a sensor which is active during the inhalation and which communicates with a processor which controls the release of the fluid medium from the container. This enables the release of the fluid medium based on a sensed property. The sensor may be located in the insertion tube, or in the box, or in the container, or in the pipe. Alternatively, the sensor may be located distant from the system, e.g. on the person. In that case, communication with the processor may be wireless or wired.

[0099] The flow control structure may e.g. effect fluid flow from the container only in response to different redefined events, e.g. at specific points in time, e.g. only during sleep, e.g. only during REM sleep.

[0100] The box can also be closed and only open if there is a sign of incipient seizure, e.g. upon detection of an incipient heart attack.

[0101] The fluid medium may be a drug substance contained as flowable powder or in liquid form. The system may include means enhancing evaporation, mixing and delivery of the substance, e.g. including a mixer, a blower fan, and heating means etc. Such elements may be placed in the box 24, in the container 3, in the pipe 27, or even in the insertion tube 2.

[0102] FIG. 15 illustrates an electronic module 28 inserted between the insertion tube 2 and the container 20. The electronic module 28 controls the flow of the fluid medium 29 from the container to the probe 30 and thus the delivery of the fluid medium in the internal flow path.

[0103] FIG. 16 illustrates an embodiment of the nasal delivery system in which the exhaust air does not flow along the outer surface of the tubular wall but rather in an inner tube 31 which extends in the internal flow path 32.

[0104] During inhaling, the air flows through the one-way valve 33 into the internal flow path 32 and into the nostrils 34. The valve 35 controls the flow of the liquid 36 from the container 37 into the internal flow path.

[0105] During exhaling, the air flows through the inner tubes 31 to the ambient space.

[0106] FIG. 17 illustrates the nasal delivery system from FIG. 16 seen from below the nostrils.

[0107] FIGS. 18A and 18B illustrate an embodiment of a nasal delivery system 1 comprising two U-shaped tubes 2A, 2B. At the intermediate leg 11, both tubes form an opening 40 whereby internal flow path of the two tubes are in communication with each other. In inner tube 2B comprises a movable closing member 41. During inhalation through the left nostril (illustrated by the arrow 8), the closing member 41 will move to the left due to the open upper end, whereby the left part of the inner tube 2B is blocked and the primary flow will be from the outer tube 2A to the inner tube 2B as indicated by the arrows. Thus, the flow will be toward the non-active nostril.

[0108] The nostril with the greatest flow through is typically where the mucosa is most shrunk whereby the absorption through the mucosa may be significantly reduced. Therefore, it may be an advantage to have the flow to the nostril that is least active. However, in other cases where the medicine should be absorbed through the odour organ, it may be easier to get the medicine if the mucosa is shrunk.

[0109] By use of the closing member, it is therefore possible to control the fluid flow of powder and/or medicine in the active nostrils or in the passive nostrils depending on which model is chosen.

[0110] The movable closing member may be used in combination with a timer, whereby the nasal delivery system may be inactive until it is activated by the timer. Thus, the movable closing member 41 can be activated at the first inhalation, block the flow path with the highest flow, after which the flow will be sent in the opposite direction.

[0111] FIG. 19 illustrates an embodiment of a nasal delivery system 1 coupled to an oxygen breathing apparatus 42. During oxygen treatment the mucosa in the nose may dry out and may even chap. However, this may be avoided by moistening the oxygen to be inhaled. In one embodiment, the nasal delivery system 1 comprise two U-shaped tubes, a tube 2 comprising salt water 43 being coupled to a U-shaped tube 44 which is coupled to an oxygen delivery system 45. The two tubes are attached to each other, without communication there between. The tube 2 will emit moisture to the nostril which is active and to thereby avoid drying, while oxygen is delivered through the tube 44. The double U-shaped tube may be replaced every day to avoid infections and avoid drying while delivering oxygen into the nostril that is active.

[0112] FIGS. 20-23 illustrate embodiments of a nasal delivery system comprising one or more magnets 46. In FIG. 20, a single magnet 46 is arranged in the internal flow path 15. During breathing the magnet 46 will move with the flow caused by breathing. In FIG. 21, a coil 47 is arranged around the nasal insertion tube 2, whereby it is possible to measure movement of the magnet 46 and thereby monitor the breathing. To facilitate monitoring an amplifier A is used. The electrical signal generated by movement of the magnet 46 in the coil 46 is measured by the sensor 48A.

[0113] FIG. 22 illustrates that monitoring of breathing can be unreliable if the person is lying at one side (indicated by the direction of the U-shaped tube 2), as the magnet 46 will move towards the bottom in this situation. Breathing will in most situations not be able to counteract gravity, and monitoring will impossible, or at least unreliable.

[0114] If a magnet 46 is fixed at opposite ends of the intermediate leg 11, as illustrated in FIG. 23, the middle magnet 46 will move in a magnetic field whereby gravity can be neglected. If a coil is arranged around the tube as illustrated in FIG. 21, movement of the magnet 46 can be measured thereby allowing monitoring and measuring of the breathing.

[0115] FIG. 24 illustrates an embodiment of a nasal delivery system 1 comprising a measuring sensor 48B. The sensor 48B is arranged partly in the internal flow path 15 and is configured for measuring of the breathing. The sensor 48B comprises three metal elements 49A, 49B, 49C, where 49A and 49B are movably attached to the isolating back plate 50. The isolating back plate 50 ensures that the three metal elements are isolated from each other.

[0116] In FIG. 24A the sensor 48 is seen form above, whereas FIGS. 24B and 24C are side view from different angles.

[0117] FIG. 25 illustrates details of the measuring sensor 48B of FIG. 24. In the left part of FIG. 25, the flow is toward the right side (indicated by the arrow 8). Consequently, the movable plates 49A and 39B will bend to the right. Due to contact between the element 49A and the non-movable element 49B, an electrical signal can be measured. This can be measured by the sensor 51. The right part of FIG. 25 illustrates the opposite situation where the flow is toward the left side (indicated by the arrow 8).

[0118] FIG. 26 illustrates an embodiment with a container 3 and a sensor 48. The left part of FIG. 26 illustrates a nasal delivery system 1 comprising a container 3 (as described above), whereas the right part of FIG. 26 illustrates a nasal delivery system 1 comprising a sensor 48B configured to monitor/measure breathing (as described above). The + indicates that the two embodiments may be combined.

[0119] Thus, medicine may be supplied from a container 3. The flow may be directed to nostril with the highest flow, e.g. by use of the movable closing member 41 as illustrated in FIGS. 18A and 18B. However, by using the information from the sensor 48B which measures the breathing it will be possible to direct the medicine into the nostril with the highest flow in or in the nostril with the lowest.

[0120] It may be possible to release the medicine at the end of the tube, e.g. via a nebulizer or by a pump.

[0121] FIG. 27 illustrates different views of the embodiment illustrated in FIG. 26. The upper left part illustrates the integrated nasal delivery system 1 from above, whereas the upper right part is a front view, and the lower part is a side view.