AU622126B2 - A device for filling a solution into a nasal cavity - Google Patents

Description

l DECLARED at Lund, Sweden this 30th day f May A.D. 19 AKTIEBOLAGET DRACO Claes-Erik Wilhelmsson President l~ TO: The Commissioner of Patents OPI DATE 05/07/89 APPLN- ID 27181 88 PCT wo AOJP DATE 27/07/89 PCT MIJMBER PCT/SE88/00640 INTERNATIONAL APPLICf O UB SHE U NER T PATENT COOPERATION TREATY (PCT) (51) International Patent Classification 4 International Publication Number: WO 89/ 05163 A61M 11/00, A61H 33/04 Al (43) International Publication Date: 15 June 1989 (15.06.89) (21) International Application Number: PCT/SE88/00640 (74) Agents: HYTTING, Kerstin et al.; AB Astra, Patent and Trademark Department, S-151 85 Sadertlje (SE).

(22) International Filing Date: 24 November 1988 (24.11.88) (81) Designated States: AT, AT (European patent), AU, BB, BE (31) Priority Application Number: 8704768-4 (European patent), BG, BJ (OAPI patent), BR, CF (OAPI patent), CG (OAPI patent), CH, CH (European patent), CM (32) Priority Date: 30 November 1987 (30.11.87) (OAPI patent), DE, DE (European patent), DK, FI, FR (European patent), GA (OAPI patent), GB, GB (European pa- (33) Priority Country: SE tent), HU, IT (European patent), JP, KP, KR, LK, LU, LU (European patent), MC, MG, ML (OAPI patent), MR (OA- PI patent), MW, NL, NL (European patent), NO, RO, SD, (71) Applicant (for all designated States except USi: AKTIEBO- SE, SE (European patent), SN (OAPI patent), SU, TD (OA- LAGET DRACO [SE/SE]; Box 34, S-221 00 Lund PI patent), TG (OAPI patent), US.

(72) Inventors; and Inventors/Applicants (for US only) ANDERSSON, Jan, An- Published ders, Roland [SE/SE]; Lundavagen 5, S-240 17 S6dra Sand- With international search report.

by LINDAHL, Jan-Erik [SE/SE]; Neptunusgatan 4, S- With amended claims.

223 57 Lund LOFSTEDT, Sigmund, Johannes [SE/SE]; In English translation (filed in Swedish.

Ekgatan 7, S-564 00 Bankeryd NERBRINK, Ola [SE/ SE]; St. S6dergatan 44, S-223 54 Lund NILSSON, Nils, GOsta, Alvar [SE/SE]; R6nnb.rsgranden 14, S-223 56 Lund WETTERLIN, Kjell, Ingvar, Leopold [SE/SE]: VastervAng 19, S-240 17 S6dra Sandby (SE).

(54) Title: A DEVICE FOR FILLING A SOLUTION INTO A NASAL CAVITY (57) Abstract The invention relates to a device for filling a solution into a nasal cavity. The device comprises a prefilled container (10) which is connected to a nasal olive (12) which fits tightly in a nostril an angle setting device for setting an angle of inclination of the head being necessary for filling the nasal cavity and means for pressing the solution from the container into the nasal cavity The invention also relates to a use of the device for administering a medicament and for measuring the nasal volume as well as a method for filling a solution into the nasal cavity. 41 39 I ii 3 1 811 I; i WO 89/05163 PCT/SE8/00640 1 A device for filling a solution into a nasal cavity Field of the invention The present invention relates to a device intended for filling a nasal cavity with a solution. The invention also relates to the use of a device for filling a nasal cavity with a solution and a method for filling a nasal cavity with a solution.

Background of the invention The nose with its nasal cavities has a complicated anatomy due to the complicated pattern which is formed by the turbinates, behind which the osties, or the orifices to the sinus paranasales are hidden. Locally administered drugs which are introduced into the nostrils as drops, spray or powder, will mainly only reach those parts of the mucous membrane which face the openings of the nostrils.

Distribution studies show that the discharged dose is not distributed to the whole nasal mucous membrane since the medicament will be brought the nearest way from the place of application towards the pharynx by means of the mucocillary function. Deep nasal breathing will only slightly contribute to a better local effect on the mucous membrane since the inhalation air has a laminar flow and has mainly been observed to pass only through the lower parts bf the nose.

Illnesses of the mucous membranes in the nose affect the whole mucous membrane area and a pharmacological substance, in itself efficient, will not be clinically effective if not the whole affected area is reached by the treatment.

Inadequate pharmacological effects of locally administered drugs at e.g. vasomothor rhinitis and allergic rhinitis as well as congestion of the osties are due to the fact that the drug WO 89/05163 PCT/SE88/00640 2 only reaches limited and "wrong" parts of the mucous membranes.

A need exists for measuring the effect of a treatment of mucous membrane congestion in connection with diagnosis, therapy and research. Rhinomanometry cr measurement of the airflow is the most used method for these measurements of the effect of a treatment. The method is expensive, clumsy and requires computer supported calculations and it is therefore only used in large hospitals. Nasal peak flow measurement is another and more simple method for these measurements, but this method has the disadvantage of being inexact.

A device formed as a "duck" has been developed for irrigation and moistening with a nasal olive which tightly fits into the nostril. The patient regulates the flow of the lavage fluid by applying a finger against a hole in the container, thereby regulating the introduction of air into the container. The device has proved unpleasant to use for the patient since the lavage fluid easily flows back into the pharynx. Furthermore, the whole mucous membrane cannot be reached by the lavage fluid.

Thus, a need exists for finding a simple way, without discomfort for the patient, of reaching the whole mucous membrane in the nasal cavity with a pharmacological solution or an lavage fluid to attain a high degree of effect of the drug or of the irrigation and moistening. A need also exists for a simple and efficient method for measuring changes in the volmne of the mucous membrane, the so-called nasal volumetry.

Summary of the invention The object of the present invention is to solve the above problems by providing a device enabling the filling of a solution into substantially the whole nasal cavity without risking that the solution flows down in the pharynx.

1 WO 89/05163 PCT/SE88/00640 3 According to the invention a device of the kind described by way of introduction is characterized in that it comprises a pre-filled container with a nasal olive which tightly fits into a nostril, an angle setting device for setting an angle of inclination of the head being necessary for the filling of the nasal cavity and means for pressing the solution from the container into the nasal caviLy.

The invention also comprises a use of the device described above and a method for filling a solution into a nasal cavity.

Other advantageous features of the invention will be apparent from the following description of embodiments of the invention and from the dependent claims.

The invention is based on the anatomy of the nose which has such a form that the level or the threshold of the connection between the nasal cavity and the pharynx is located at a higher level than the inner end of the nasal septum when the head is inclined about 600 from an upright position. When, in this position of the head, a solution is introduced via a tight nasal olive, one half of the nasal cavity will be filled with the solution apart from a small volume above the upper nasal turbinate. Excessive filling will cause the overflow to run over the inner end of the nasal septum and out through the lateral nostril. No solution will flow down into the pharynx.

According to the invention an angle setting device controls the position of the head in such a way that an optimal filling of the nasal cavity can be obtained without risking that the solution runs back into the pharynx, which would be very unpleasant for the patient.

The invention can preferably be used for administration of drugs, such as decongestant medicament, or for the WO 89/05163 PCT/SE88/006 4 0 4 purpose of irrigating and moistening. An additional field of application is so-called nasal volumetry where changes in the volume, e.g. the thickness, of the mucous membrane is measured. Other fields of application are also possible within the scope of the invention.

When the solution consists of a pharmacological solution, the ihidden parts of the nasal cavity, such as the osties, which could not be reached with prior methods, will be reached by the medicament and a satisfactory effect of the medicament can be achieved. The device, which comprises means for pressing the solution into the nasal cavity, has the advantage of keeping the solution in movement by pumping it back and forth resulting in an efficient irrigation of the mucous membranes. When the solution is a drug solution, the concentration of the drug and the time of exposure in the nasal cavity are decisive for the local effect on the mucous membrane as well as for the possible systemic absorption of the drug.

The device according to the invention is suitable for measuring changes of the thickness of the mucous membrane in a nostril. These measurements are a simple, painless and inexpensive way to measure the effect of decongestant treatment of the mucous membrane. The nasal cavity can theoretically be compared to a tunnel with rigid outer bone gristle walls. The volume within said walls is invariable and is filled by two components, mucous membrane and air. The ratio between the mucous membrane volume and the air volume changes continuously in dependance of the position of the body and the activity as well as allergic and vasomothoric actions. When measuring the effect by nasal volumetry, the measured difference in the volume is equivalent to the change in volume of the mucous membrane.

Other fields of application of the device according to the invention are different types of lavage-purposes such as cytologic, enzymic and histaminic evaluations as well as -F WO 89/05163 PCT/SE88/00640 irrigation of noses in connection with radiotherapy and specific cancer forms. The device can also be used for irrigation purposes for workers and craftsmen in a dusty environment.

In tests which have been carried out in order to find limit values for the angle of inclination of the head, it has been tested, among other things, at which angle the solution will flow back into the pharynx instead of over the inner end of the nasal septum. It has been established that the limit angle differs to some extent between men and women. The tests have shown that at an angle of inclination within the interval 55*-90', the inner end of the nasal septum is in all tests lower than the connection between the nasal cavity and the pharynx and consequently no risk for an overflow into the pharynx exists. It has also been found that the patient will have difficulties in estimating the angle of inclination of the head by himself without any means of assistance.

Brief description of the drawings An embodiment of a device for filling a solution into a nasal cavity according to the present invention and modifications thereof will be described in detail below with reference to the accompanying drawings, where Fig. 1 shows a sectional view of the nasal cavity filled with a solution and a first embodiment of the invention, Figs. 2 a-b show a sectional view of a second embodiment of the invention in two different angular positions, Figs. 3 a-b show a sectional view of a third embodiment of the invention in two different angular positions, Figs. 4 a-d show an alternative embodiment of the angle setting device, WO 89/05163 PCT/SE88/00640 6 Fig. 5 shows an additional embodiment of the invention, Fig. 6 shows an alternative embodiment of the container.

Detailed description of preferred embodiments of the invention Fig. 1 shows the nasal cavity of a patient where the cavity is being filled with a solution by means of a first embodiment of the invention. The head of the patient is bent at a specific angle of inclination from an upright position and the head is held in that specific angular position by an angle setting device The angle setting device is provided with two horizontal holders with suction cups at their outer ends, which are intended to be pressed against a vertical wall such as a mirror. In order to hold the head of the patient in a predetermined angle position, three different abutting faces are arranged and shaped to conform to the face. The different abutting faces abut the forehead, upper lip and chin of the patient. Two lateral abutting faces (only one is shown in Fig. 1) are adapted for abutting the cheek bones and are intended for the lateral fixation of the head.

A compressible disposable container (10) is initially filled with asolution such as a physiological salt solution or a pharmacological solution, depending on the purpose for filling the nasal cavity with a solution. The volume of the solution in the container (10) is preferably somewhat larger than the volume of the nasal cavity which varies between 10-18 ml from individual to individual. The container isequipped with a nasal olive (12) at its opening said olive (12) having a conical shape in order to fit tightly into the inner surfaces of the nostril when it is inserted into nostrils (13) of different sizes. To provide a satisfactory sealing action in different nostrils, the base diameter of the nasal olive (12) should be between 15 and 23 mm, preferably 19 mm, while the smaller top diameter WO 89/05163 PCT/SE88/00640 7 preferably should be about 7 mm. To prevent the solution in the container from being sprayed into the nasal cavity it is essential that the opening of the nasal olive (12) has a sufficient extent, which means a diameter of at least 4 mm.

Fig. 1 shows how the solution has been pumped up into the nasal cavity to be level with the inner end (14) of the nasal septum. As can be seen in Fig. 1 this level is lower than the level of the threshold (15) of the connection between the nasal cavity and the pharynx (16) at the angle of inclination which has been set by the angular setting device When additional solution is pumped into the nasal cavity the excess solution will flow over the inner end (14) of the nasal septum into the other nostril and the extremely unpleasant overflow into the pharynx is avoided. The solution can be kept in motion by pumping the solution into and out from the flexible container To measure the changes in the mucous membrane volume in the nose the container (10) is compressed to press all solution up to the nasal cavity The excess solution will run out through the other nostril. The solution that still remains in the nasal cavity will be drawn back into the container (10) and the volume or the weight of the regained solution is measured. This can easily be done by providing the container with an indicating scale. After treatment with a locally active pharmacological solution affecting the congestion of the mucous membrane, the measuring procedure as above is repeated. The difference between said two volumes is a measure of the efficiency of the pharmacological treatment.

Figs. 2 a-b show a second embodiment of the invention where the angle setting device and the container form one composite unit. Fig. 2 a shows the device in an upright position and Fig. 2 b shows the device in a position where the head of the patient is bent forward about 60'. In order to achieve that the inclination of the device corresponds to WO 89/05163 PCT/SE88/0064O 8 the inclination of the head, the position of the composite unit must be fixed in relation to the position of the patient's head. This fixation can be achieved by means of a fixing device (not shown in the Figure) on the container which keeps the container fixed to the head of the patient.

As an alternative, an outer modelled surface (17) may constitute an abutting face for the face of the patient, fixing the position of the composite unit.

A compressible container (10) is connected to a nasal olive(12) via a rigid conduit (18) in the unit. A valve (19) between the container (10) and the conduit (18) consists of a valve body (20) with a bottom part (21) which is inclined towards the connection to the tube. The connection of the tube to the valve body forms a valve seat for a valve ball In the position according to Fig. 2 a the bottom part (21) has an angle of inclination from the horizontal plane of about 500.

In its first position (see Fig. 2a), the prefilled container is closed by the valve When the nasal olive has been introduced into the patient's nostril (13) and the device has been fixed to the head, the patient bends his head forward until the device has the position shown in Fig. 2 b.

The angle of inclination is here also about 600. At this angle the ball valve (22) rolls out of its position in the valve seat (21) by means of the gravitational force and the connection between container (10) and nasal olive (12) is being opened. At this point the solution can freely be pumped between container (10) and nasal cavity (12) as long as the patient keeps the specific angle of inclination which prevents the solution from flowing back into the pharynx and which permits substantially the whole nasal cavity to be filled with a solution.

A modification of the device according to Figs. 2 a-b comprises a nasal olive connected to a flexible container and which includes an intermediate valve. The container is WO 89/05163 PCT/SE88/00640 9 here located below the valve body with the opening directed upward. One or several conduits are connected to the opening -of the container, extending to and around the valve body and joining said body from above. The valve is identical with the valve shown in Figs. 2 a-b, i.e. the valve comprises a heavy valve ball and a valve body with an inclined bottom part. The inclined bottom part of the valve is connected to the nasal olive, which is located above the valve, by means of a curved tube. Thus, when the container is compressed, the solution will flow up through the conduits past the valve body and down into the valve towards the inclined bottom part. When the device is in an upright position, the valve ball closes the connection to the tube, while in the inclined position of the device corresponding to the desired angle of inclination, the valve ball rolls away from its closing position by means of the gravitational force, thus opening the connection to the nasal olive.

Figs. 3 a-b show an alternative embodiment of a device where the angle setting device and the container form a composite unit. The device is to be combined with a unit (not shown) for fixation of said device in relation to the patient's head in the same way as in the embodiment according to Figs. 2 a-b.

The prefilled compressible container (10) is connected to the nasal olive (12) via two conduits (23,24), one of which is enlarged A floating valve ball (25) is arranged in the enlarged conduit (23).

The upper branches of the two conduits have an inclination of about 450 in relation to the longitudinal axis of the device, the branches then being united and continuing in a neck (28) ending in the nasal olive A knee (29) is arranged in the enlarged conduit (23) where the conduit bends into the upper branch.

WO 89/05163 PCT/SE88/006 4 0 When the container (10) is compressed in its upright position according to Fig. 3 a, (shown in dashed lines in Fig. 3 a), the ball (25) floats on the rising liquid surface and is stopped against the constriction of the neck (28) and closes the connection to the nasal olive When the container is compressed in its inclined position according to Fig. 3 b (angle of inclination about 600), the solution flows past the angled part of the channel (24) and the ball (25) is carried away from the constriction in the neck (28) by the flow and is pressed against the knee (29) by the rising liquid level, so that the connection between the container (10) and the nasal olive (12) is opened. and is kept open as long as the required angle of inclination is maintained.

An angle setting device adapted for indication of the specific angle is shown in Fig. 4 a. The device is based on the knowledge that the line between the upper part of the ear and the root of the nose is horizontal when the head is in an upright position and that the distance between the upper part of the ears and the root of the nose is substantially constant for different individuals. The device consists of a pair of spectacles (30) which are modified in such a way that both lenses are covered except for certain thin slits. From Fig. 4 a it can be seen that one lens is provided with a narrow central slit (32) and the other lens is provided with one upper edge (34) and one lower edge slit The use of the modified spectacles according to Fig. 4 a is shown in Figs. 4 b-d. To find an initial position the patient looks fixedly at an object at eye level without spectacles so that the head is in an upright position. With the spectacles firmly on, an index point I (36) is fixedly observed with eye I through the central slit (32) in the covered lens (31).

(See Fig. 4 Fig. 4 c shows how eye II finds an index point II (37) through the lower edge slit (35) of the covered lens In Fig. 4 b it can be seen how the head then is bent until the index point II (37) is observed in the upper edge slit (34) in the covered lens At this point WO 89/05163 PCT/SE88/00640 11 the head has the angle of inclination which is necessary for obtaining an optimal effect for filling a liquid into the nasal cavity.

A simpler form of the modified spectacles is obtained when only one lens is covered and is formed with an upper edge slit and a lower edge slit, the distance between the two slits being slightly less than the distance in Fig. 4 a.

First, the uncovered eye is fixed on an index point I at eye level when the head is in its upright position. Then the index point I is fixedly oberserved through the upper edge slit and simultaneously another index point II is fixedly observed through the lower edge slit. The head is then bent further until the index point II can be fixedly observed through the upper edge slit. The required angle of inclination has now been attained.

An alternative embodiment of a angle setting device which indicates the specific angle of inclination is shown in Fig. 5. The device is here shown in a position wherein the specific angle of inclination has not yet been attained.

The device comprises an angle setting device which is fixedly attached to the neck between the compressible container (10) and the nasal olive The angle setting device is fixedly attached to the container by means of a resilient yoke (38) which can be attached to and removed from the neck of the container.

The angle setting device comprises an angular support (39) which at one end ends with the yoke (38) and at the other end has an abutting face shaped to conform with the forehead. An arm (41) is rigidly connected to said other end. The arm (41) forms an angle with the vertical plane of the head (in its upright position) which corresponds to the angle of inclination and the arm consequently forms an inclinometer. The outer end of the arm (41) is provided with a marking such as a colour marking. A pendulum (43) is WO 89/05163 P CT/S;E88/0040 12 pivotally connected to the inner end of the arm (41) on an axis said pendulum (43) forming a plumbline indicator.

The outer end of the pendulum (43) is provided with a marking corresponding to the marking (42) of the arm.

When using the device according to Fig. 5, the yoke (38) is pressed around the neck of the container, the nasal olive(12) is inserted into the nostril (13) and the abutting face abuts the patient's forehead. The patient bends his head forward until the marking (45) of the pendulum coincides with the marking (42) of the arm. In this position the container can be compressed and the solution can be pumped into the nasal cavity.

However, other types of angle setting indicators are conceivable within the scope of the invention. For example, a pivotable plumbline indicator can display different colour markings depending on the specific angle of inclination and can for example display a green marking when the required angle of inclination has been attained. The angle of inclination can also be indicated by a sound signal or a light signal by battery.

Fig. 6 shows an embodiment of a non-compressible container (10) with a vent aperture The container is connected to the nasal olive (12) via a flexible tube In order to pump the solution up to the nasal cavity, the container is held above the level of the nasal cavity so that when air is introduced through the vent aperture (46) the solution Jis able to flow from the higher positioned container through the tube (47) and the nasal olive (12) and further up to the nasal cavity To get the solution back into the container, said container is lowered below the level of the nasal cavity so that the solution flows back into the container and the air flows out through the vent aperture.

Claims (12)

1. A device for filling a nasal cavity with a solution, characterized in that the device comprises a container (10) prefilled with said solution and ;with a nasal olive (12) which tightly fits a nostril, an angle setting device for setting an angle of inclination of the head which is necessary for the filling of the nasal cavity and means for pressing the solution from the container (10) into the nasal cavity

2. A device according to claim 1, characterized in that the prefilled container (10) is compressible, preferably in the shape of bellows, in order to enable the solution to be pumped from the container (10) into the nasal cavity

3. A device according to claim 1, characterized in that the prefilled container (10) is rigid and has a vent aperture. (46) and is connected to the nasal olive (12) via a flexible tube which enables the container (10) to be elevated above the level of the nasal cavity in order to force the solution from the container (10) into the nasal cavity

4. A device according to claim 1, 2 or 3, characterized in that the angle setting device can be fixedly attached to the head and is arranged to indicate the necessary angle of inclination of the head for the filling of the nasal cavity A device according to claim 4, characterized in that the angle setting device can be fixedly attached to the container (10) by means of a connecting device (38) and to the head by means of an abutting face said connecting device (38) and said abutting face (40) each being arranged on a respective end of an angular support (39).

6. incli said pivot neces

7. that abutt 10 attac head neces

8. 15 angle betwe valve said valve 20 incli cavit

9. angle 25 (31, one 1 (33) 30 angle the n

11. 35 in th admin >1 r-r cv Q AnAA(I W J A 0 89f0U5163 T- r7LLOO'.. 6. A device according to claim 5, characterized in that an inclinometer (41) is attached to the angular support (39), said inclinometer (41) coinciding with a pendulum (43) being pivotally connected to the inclinometer when the necessary angle of inclination of the head is attained. 7. A device according to claim i, 2 or 3, characterized in that the angle setting device consists of a stand having abutting faces 9) for the head and which can be fixedly attached onto a rigid surface said stand enabling the head to be fixed in an angle of inclination being necessary for the filling of the nasal cavity. 8. A device according to claim 2, characterized in that the angle setting device comprises a valve (19; 25, 28) between the container (10) and the nasal olive(12), said valve being opened at a predetermined angle of inclination, said container being fixed to the head in such a way that the valve is opened when the head is bent to the angle of inclination being necessary for the filling of the nasal cavity 9. A device according to claim 4, characterized in that the angle setting device comprises spectacles having lenses (31, 33) being covered except for thin slits (32, 34, one lens (31) having a central slit (32) and the other lens (33) having slits at the upper and at the lower edge (34, 10. A device according to claim i, characterized in that the angle of inclination being necessary for the filling of the nasal cavity is between 550 and 900, preferably 600. 11. Use of a device according to claims 1-10, characterized in that said solution is a pharmacological solution being administered into the nasal cavity. IR: i1

12. A method for filling a solution into a nasal cavity, by means of a device according to any one of claims 1 to 10, characterized in that the head is bent forward between 55° 90°, preferably 60°, from an upright position, thereby keeping the wall between the two nasal cavities at a lower level than the level of the connection between the nasal cavity and the pharynx, whereupon the nasal olive (12) of said device is fitted into a nostril and the solution is pressed or pumped into the nasal cavity .0 from the container (10) of said device via the nasal olive (12) fitting into the nostril. 1 4 e

13. A method according to claim 12, characterized in that all the solution in the container (10) is pressed into the nasal cavity so that an excessive amount of solution will overflow to the lateral nostril, whereupon the remaining solution is drawn back into the container (10) for measuring the inner volume of the cavity.

14. A method according to claim 13, characterized in that subsequent measurements are carried out for measuring volume changes of the mucous membrane in the nasal cavity