A head model for testing of inhalation drugs

Abstract

A head model (1) for testing of inhalation drugs, said head model (1) comprising a model mouth (5)with a mouth opening (5a), a model nose (9) with two nose openings (9a) and a model trachea (13) reaching from a trachea first end (13a) to a trachea second end (13b), wherein said trachea first end (13a) is configured for connection to an external device. Said head model further comprising an anatomically realistic nose flow path (15) fluidly connected to the trachea second end (13b) and reaching between the nose openings (9a) and the trachea second (end (13b) and an anatomically realistic mouth flow path (19) fluidly connected to the trachea second end (13b) and reaching between the mouth opening (5a) and the trachea second end (13b). Siad head model further comprising an adjustable restrictor (21) positioned in connection with the nose flow path (15) and arranged such that it can be adjusted to allow different amounts of flow through the nose flow path (15).

Description

[0001] A head model for testing of inhalation drugs

[0002] TECHNICAL FIELD OF THE INVENTION

[0003] The present invention relates to a head model for testing of inhalation drugs.

[0004] BACKGROUND

[0005] Testing of inhalation drugs are today performed in for example different types of throat and nasal models. Typically, either inhalation via mouth or nose is tested and different models are used for the different tests. In EP2284822B1 a model face is described which is used for evaluation of medication delivery in which a seal between the delivery apparatus and test apparatus is achieved by simulating a bone structure, a trachea, soft tissue and an epidermal skin layer. There is still a need for more versatile and realistic head models for the testing of inhalation drugs.

[0006] SUMMARY

[0007] An object of the invention is to provide a more versatile inhalation testing model.

[0008] This is achieved in a head model according to claim 1.

[0009] According to one aspect of the invention a head model for testing of inhalation drugs is provided. Said head model comprising: a model mouth with a mouth opening; a model nose with two nose openings; a model trachea reaching from a trachea first end to a trachea second end, wherein said trachea first end is configured for connection to an external device; an anatomically realistic nose flow path fluidly connected to the trachea second end and reaching between the nose openings and the trachea second end; an anatomically realistic mouth flow path fluidly connected to the trachea second end and reaching between the mouth opening and the trachea second end; and an adjustable restrictor positioned in connection with the nose flow path and arranged such that it can be adjusted to allow different amounts of flow through the nose flow path.

[0010] Hereby a head model for testing of inhalation drugs is achieved which is more versatile, i.e. it can be used for different types of testing. Both inhalation via nose and mouth can be investigated, either simultaneously or only via mouth by adjustment of the adjustable restrictor for the nose flow. The adjustable restrictor can be adjusted such that the flow via the nose is fully or partly restricted or fully open. The control of the restrictor may be stepless, whereby a more functionally realistic head model is achieved. The adjustable restrictor can mimic the function of the soft palate whereby inhalation for different situations, such as partly obstructed nose or for different body positions such as lying in a bed can be tested. The head model according to the invention can be used for both inhalators and face masks whereby different devices can be tested and compared using the same head model.

[0011] In one embodiment of the invention the adjustable restrictor is provided in a position in the head model to simulate a flow regulation function of a soft palate provided between the nose flow path and the mouth flow path. Hereby a functionally realistic head model is provided.

[0012] In one embodiment of the invention the adjustable restrictor comprises a movable plate which can be controlled to change position inside the head model from outside the head model and which can be positioned in at least an open position where the plate is positioned outside the nose flow path and a closed position where the plate is blocking the nose flow path.

[0013] In one embodiment of the invention a position of the adjustable restrictor can be regulated steplessly such that it can block a flow through the nose flow path to different amounts. Hereby different conditions, such as partly obstruction of the nose and nose flow path can be simulated and used for testing of inhalation drugs. Hereby a versatile and functionally realistic head model is achieved.

[0014] In one embodiment of the invention the head model further comprises at least one flow detection arrangement comprising a measuring passage reaching from a connection end on an outside surface of the head model to an inner measuring position provided inside the head model in connection with the mouth flow path or the nose flow path, whereby a flow rate at the measuring position can be measured via said measuring passage. Hereby a flow rate via the mouth flow path and the nose flow path can be measured and monitored and the adjustable restrictor can be controlled in dependence of the measured flow rate.

[0015] In one embodiment of the invention the head model comprises at least two flow detection arrangements where the inner measuring positions of the at least two flow detection arrangements are positioned in at least two different positions chosen from: in connection with the mouth flow path, in connection with the nose flow path and in connection with the model trachea.

[0016] In one embodiment of the invention said head model further comprises at least one sensor arranged for measuring flow rate or pressure, said sensor being positioned in connection with at least one of the mouth flow path and the nose flow path.

[0017] In one embodiment of the invention the model mouth is provided in an exchangeable mouth insert part of the head model. Hereby different model mouths having different shapes can be inserted into the head model and hereby the model mouth can be adapted for different types of inhalators or face masks. Also a closed model mouth can be provided in an exchangeable mouth insert part whereby inhalation via only the nose flow path can be tested.

[0018] In one embodiment of the invention said head model comprises at least two different exchangeable mouth insert parts which are simulating different mouth positions.

[0019] In one embodiment of the invention the head model comprises at least a part of a face comprising the model mouth and the model nose which is anatomically realistic. Hereby for example a face mask can be attached to the head model in a realistic way for testing of inhalation drugs.

[0020] BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure l is a perspective view of a head model according to one embodiment of the invention. Figure 2 is a perspective view of a model trachea, a nose flow path and a mouth flow path separated from the head model.

[0022] Figure 3 is a cross section of the head model shown in Figure 1.

[0023] Figures 4a and 4b show two perspective views of the head model shown in Figure 1 with details of the adjustable restrictor.

[0024] Figures 5a-c are cross sections of the head model shown in Figure 1 in which the adjustable restrictor is provided in three different positions.

[0025] Figure 6 is a cross section of the head model shown in Figure 1 in which three flow detection arrangements are marked.

[0026] Figures 7a-c are perspective views of three different mouth insert parts of a head model according to one embodiment of the invention.

[0027] DETAILED DESCRIPTION OF EMBODIMENTS

[0028] According to the invention a head model for testing of inhalation drugs is provided. A head model 1 according to one embodiment of the invention is shown in different views in Figures 1, 3, 4, 5 and 6. In Figure 2 a perspective view of a model trachea 13, a nose flow path 15 and a mouth flow path 19 separated from the head model 1 is shown and in Figures 7a-c three different mouth insert parts 81a-c of a head model 1 according to one embodiment of the invention are shown which will be further described below. With reference to all the Figures 1-7 the head model 1 according to the invention will now be described. Only one embodiment of the head model 1 is illustrated however different alternatives for different parts of the head model 1 will be discussed below and hereby covered by the invention.

[0029] The head model 1 comprises a model mouth 5 with a mouth opening 5a and a model nose 9 with two nose openings 9a, i.e. two nostrils. The head model 1 comprises in this embodiment also a realistic model face 8 comprising said model mouth 5 and said model nose 9. Suitably at least a part of the model face 8 is anatomically realistic. Suitably a part of the model face comprising the model nose 9, the model mouth 5 and parts of cheeks is realistic in order to fit together with inhalators and / or masks for inhalation to be tested. The head model 1 comprises furthermore a model trachea 13 reaching from a trachea first end 13a to a trachea second end 13b, wherein said trachea first end 13a is configured for connection to an external device. The external device can be an inhalation testing equipment comprising devices for mimicking breathing or inhalation and devices for detection of particles. For example an artificial lung, a bellow or a pump for mimicking breathing or inhalation can be connected to the trachea first end 13a and one or more filters and / or particle counting devices for detection of particles can be connected to the trachea first end 13a whereby and number and possibly sizes of particles can be determined.

[0030] The head model 1 comprises also an anatomically realistic nose flow path 15 fluidly connected to the trachea second end 13b and reaching between the nose openings 9a and the trachea second end 13b and an anatomically realistic mouth flow path 19 fluidly connected to the trachea second end 13b and reaching between the mouth opening 5a and the trachea second end 13b. An anatomically realistic nose flow path 15 and an anatomically realistic mouth flow path 19 may be achieved from CT-scans from people of different ages. The head model 1 according to the invention can be provided in different sizes, i.e. as a head model mimicking people of different ages, every age between newborn to old. In Figure 2 a perspective view of a model trachea 13, a nose flow path 15 and a mouth flow path 19 which are separated from the head model 1 is shown. This is only for illustration purpose and this structure correspond to the open passages being the model trachea 13, the nose flow path 15 and the mouth flow path 19 inside the head model 1. In Figures 3, 5 and 6 different cross sections of the head model 1 are shown. Because of the complicated structure of especially the nose flow path 15 it is hard to get a cross section in which both the whole mouth flow path 19 and the whole nose flow path 15 are visible. In Figures 5 and 6 a part of the nose flow path 15 is illustrated schematically by dotted lines.

[0031] The head model 1 comprises furthermore an adjustable restrictor 21 positioned in connection with the nose flow path 15 and arranged such that it can be adjusted to allow different amounts of flow through the nose flow path 15. The adjustable restrictor 21 is arranged to open or close the nose flow path 15 for flow to different amounts. In one embodiment of the invention (as shown in Figures 1-6) the adjustable restrictor 21 is provided in a position in the head model 1 to simulate a flow regulation function of a soft palate 22 provided between the nose flow path 15 and the mouth flow path 19. The adjustable restrictor 21 is positioned within the head model 1 close to the soft palate 22 such that the adjustments of the position of the restrictor mimics a movement of the soft palate in a real human being.

[0032] The adjustable restrictor 21 can be embodied in different ways. One example is shown in the head model 1 as shown in Figures 1-6 wherein the adjustable restrictor 21 comprises a movable plate 23 which can be controlled to change position inside the head model 1 from outside the head model 1 and which can be positioned in at least an open position where the plate 23 is positioned outside the nose flow path 15 and a closed position where the plate 23 is blocking the nose flow path 15. A stepless control of the position of the movable plate 23 of the adjustable restrictor is suitably provided whereby a flow through the nose flow path can be adjusted to correspond to different conditions for different testing. In the embodiment shown in Figures 1-6 the movable plate 23 of the adjustable restrictor 21 is inserted to the nose flow path 15 from a neck 10 of the head model 1. Two screws 24 are used for adjusting the position of the movable plate 23 in this embodiment. However, other alternatives for adjusting the position of the movable plate 23 are of course possible. In other embodiments the adjustable restrictor 21 can be designed and positioned differently in the head model 1. The adjustable restrictor 21 can be positioned anywhere along the nose flow path 15 or also outside the model nose 9 for blocking the nose openings 9 to different degrees. In one embodiment of the invention the adjustable restrictor 21 is provided as adjustable inserts to be inserted into the two nose openings 9.

[0033] Suitably the adjustable restrictor 21 can be regulated steplessly, i.e. by continuous control. Hereby different amounts of obstruction via the nose can be simulated. For example blocking and partly blocking of the nose flow path 15 during a cold or partly blocking of the nose flow path during certain body positions, for example lying on the back or side, can be simulated and used for inhalation testing.

[0034] In some embodiments of the invention and as especially illustrated in Figure 6, the head model 1 further comprises at least one flow detection arrangement 31, 41, 51. Each flow detection arrangement 31, 41, 51 comprises a measuring passage 31a, 41a, 51a reaching from a connection end 31b, 41b, 51b on an outside surface of the head model 1 to an inner measuring position 31c, 41c, 51c provided inside the head model in connection with the mouth flow path 19, the nose flow path 15 or the model trachea 13, whereby a flow rate at the measuring position can be measured via said measuring passage 31a, 41a, 51a. In Figure 6 three flow detection arrangements 31, 41, 51 are schematically illustrated: one nose flow detection arrangement 31 having an inner measuring position 31c in connection with the nose flow path 15, one mouth flow detection arrangement 41 having an inner measuring position 41c in connection with the mouth flow path 19 and one trachea flow detection arrangement 51 having an inner measuring position 51c in connection with the model trachea 13 are shown. The connection ends 31b, 41b, 51b of the flow detection arrangements 31, 41, 51 can be seen in for example Figure 1. The measuring passages 31a, 41a, 51a are provided as channels through the head model 1 and are schematically illustrated in Figure 6. The measuring passage 31a of the nose flow detection arrangement 31 is illustrated by dotted lines. Said flow detection arrangements 31, 41, 51 allow pressure sensors to be connected to the connection ends 31b, 41b, 51b for measuring a pressure at the measuring position 31c, 41c, 51c. Alternatively a flow or pressure sensor can be inserted via the measuring passages 31a, 41a, 51a to the inner measuring positions 31c, 41c, 51c. Hereby, from pressure measurements fluid flow rates can be determined at different positions within the head model 1. The adjustable restrictor 21 can be adjusted based on the measured pressure / flow whereby the flow through the nose flow path 15 can be controlled with good precision. Different flow rates may cause turbulence and hereby affect the fluid flow distribution between the nose flow path 15 and the mouth flow path 19. According to this embodiment of the invention the flow rates can be monitored and controlled whereby a better control and evaluation of the testing of inhalation drugs can be provided.

[0035] In some embodiments of the invention the head model comprises at least two flow detection arrangements 31, 41, 51 where the inner measuring positions 31c, 41c, 51c of the at least two flow detection arrangements 31, 41, 51 are positioned in at least two different positions chosen from: in connection with the mouth flow path 19, in connection with the nose flow path 15 and in connection with the model trachea 13.

[0036] Instead of the flow detection arrangements 31, 41, 51 the head model 1' according to another embodiment of the invention comprises at least one sensor 73 arranged for measuring flow rate or pressure, said sensor 73 being positioned in connection with at least one of the mouth flow path 19 and the nose flow path 15. Such sensors 73 are schematically illustrated in Figure 3 where they are positioned in the same position as the inner measuring positions 31s, 41c, 51c. Such sensors 73 can for example communicate wirelessly to a control unit and / or display unit outside the head model 1' whereby the adjustable restrictor 21 can be controlled based on such measurements.

[0037] In one embodiment of the invention the model mouth 5 is provided in an exchangeable mouth insert part 81a, 81b, 81c of the head model 1. Three alternatives for mouth insert parts 81a, 81b, 81c are shown in Figures 7a-7c. The three mouth insert parts 81a, 81b, 81c simulate different mouth positions, where the mouth insert part 81a as shown in Figure 71 may be adapted for example for an inhalator, a pacifier type of inhalator or a face mask and the mouth insert part 81b as shown in Figures 7b may be adapted for another type of inhalator or pacifier type of inhalator and the mouth insert 81c as shown in Figure 7c simulate a closed mouth. A closed mouth can be used when inhalation only via the nose flow path 15 should be tested.

[0038] In some embodiments said head model 1 comprises at least two different exchangeable mouth insert parts 81a, 81b, 81c which are simulating different mouth positions. At least one of the mouth insert parts 81a, 81b may be configured for attachment to an inhalator or a pacifier type of inhalator and one mouth insert part 81c may simulate a closed mouth. Hereby different mouth insert parts 81a, 81b, 81c can be used for different inhalation testing whereby the head model 1 according to this embodiment of the invention is versatile and usable for testing of many different types of inhalation devices.

Claims

CLAIMS1. A head model (1) for testing of inhalation drugs, said head model (1) comprising: a model mouth (5) with a mouth opening (5a); a model nose (9) with two nose openings (9a); a model trachea (13) reaching from a trachea first end (13a) to a trachea second end (13b), wherein said trachea first end (13a) is configured for connection to an external device; an anatomically realistic nose flow path (15) fluidly connected to the trachea second end (13b) and reaching between the nose openings (9a) and the trachea second end (13b); an anatomically realistic mouth flow path (19) fluidly connected to the trachea second end (13b) and reaching between the mouth opening (5a) and the trachea second end (13b); and an adjustable restrictor (21) positioned in connection with the nose flow path (15) and arranged such that it can be adjusted to allow different amounts of flow through the nose flow path (15).

2. Head model according to claim 1, wherein the adjustable restrictor (21) is provided in a position in the head model to simulate a flow regulation function of a soft palate (22) provided between the nose flow path (15) and the mouth flow path (19).

3. Head model according to claim 1 or 2, wherein the adjustable restrictor (21) comprises a movable plate (23) which can be controlled to change position inside the head model (1) from outside the head model (1) and which can be positioned in at least an open position where the plate (23) is positioned outside the nose flow path (15) and a closed position where the plate (23) is blocking the nose flow path (15).

4. Head model according to any one of the preceding claims, wherein a position of the adjustable restrictor (21) can be regulated steplessly such that it can block a flow through the nose flow path (15) to different amounts.

5. Head model according to any one of the preceding claims, further comprising at least one flow detection arrangement (31, 41) comprising a measuring passage (31a, 41a) reaching from a connection end (31b, 41b) on an outside surface of the head model (1) to an inner measuring position (31c, 41c) provided inside the head model in connection with the mouth flow path (19) or the nose flow path (15), whereby a flow rate at the measuring position can be measured via said measuring passage (31a, 41a).

6. Head model according to claim 5, wherein the head model comprises at least two flow detection arrangements (31, 41, 51) where the inner measuring positions (31c, 41c, 51c) of the at least two flow detection arrangements (31, 41, 51) are positioned in at least two different positions chosen from: in connection with the mouth flow path (19) , in connection with the nose flow path (15) and in connection with the model trachea (13).

7. Head model according to any one of the claims 1-4, wherein said head model further comprises at least one sensor (73) arranged for measuring flow rate or pressure, said sensor (73) being positioned in connection with at least one of the mouth flow path (19) and the nose flow path (15).

8. Head model according to any one of the preceding claims, wherein the model mouth (5) is provided in an exchangeable mouth insert part (81a, 81b, 81c) of the head model (1).

9. Head model according to claim 8, wherein said head model (1) comprises at least two different exchangeable mouth insert parts (81a, 81b, 81c) which are simulating different mouth positions.

10. Head model according to any one of the preceding claims, wherein the head model comprises at least a part of a face comprising the model mouth (5) and the model nose (9) which is anatomically realistic.

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