Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H35/00—Baths for specific parts of the body
  • A61H35/04—Baths for specific parts of the body for the nose

Definitions

• 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.
• the nose with its nasal cavities has a complicated anatomy due to the complicated pattern which is formed by the turbinates, behind which the ostie ⁇ , or the orifices to the sinus paranasale ⁇ 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 ostie ⁇ are due to the fact that the drug only reaches limited and "wrong" parts of the mucous membranes.
• Rhinomanometry or 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.
• 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.
• 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 cavity.
• the invention also comprises a use of the device described above and a method for filling a solution into a nasal cavity.
• 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 60° from an upright position.
• 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.
• 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 purpose of irrigating and moistening.
• drugs such as decongestant medicament
• 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.
• the solution consists of a pharmacological solution
• the hidden 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.
• 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.
• lavage-purposes such as cytologic, enzymic and histaminic evaluations as well as 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.
• 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
• Fig. 5 shows an additional embodiment of the invention
• Fig. 6 shows an alternative embodiment of the container.
• Fig. 1 shows the nasal cavity (1) of a patient where the cavity is being filled with a solution (3) by means of a first embodiment of the invention.
• the head of the patient is bent at a specific angle of inclination (2) from an upright position and the head is held in that specific angular position by an angle setting device (4).
• the angle setting device (4) is provided with two horizontal holders (5) with suction cups (6) at their outer ends, which are intended to be pressed against a vertical wall (7), such as a mirror.
• three different abutting faces (8) are arranged and shaped to conform to the face.
• the different abutting faces (8) abut the forehead, upper lip and chin of the patient.
• Two lateral abutting faces (9) (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 a solution (3) 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 (10) isequipped with a nasal olive (12) at its opening (11), 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.
• the base diameter of the nasal olive (12) should be between 15 and 23 mm, preferably 19 mm, while the smaller top diameter preferably should be about 7 mm.
• 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 (3) has been pumped up into the nasal cavity (1) 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 (1) and the pharynx (16) at the angle of inclination (2) which has been set by the angular setting device (4).
• 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 (10).
• the container (10) is compressed to press all solution (3) up to the nasal cavity (1).
• the excess solution will run out through the other nostril.
• the solution that still remains in the nasal cavity (1) 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.
• 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 (4) and the container form one composite unit.
• Fig. 2 a shows the device in an upright position
• Fig. 2 b shows the device in a position where the head of the patient is bent forward about 60°.
• 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.
• 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 (22).
• the bottom part (21) has an angle of inclination from the horizontal plane of about 50°.
• the- prefilied container (10) In its first position (see Fig. 2a), the- prefilied container (10) is closed by the valve (19).
• 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 (2) is here also about 60°.
• 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.
• 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 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.
• valve ball 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 (4) 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 (23).
• a floating valve ball (25) is arranged in the enlarged conduit (23).
• the upper branches of the two conduits have an inclination of about 45° 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 (12).
• a knee (29) is arranged in the enlarged conduit (23) where the conduit bends into the upper branch.
• FIG. 4 a 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 (35).
• Figs. 4 b-d The use of the modified spectacles according to Fig. 4 a is shown in Figs. 4 b-d.
• an index point I (36) is fixedly observed with eye I through the central slit (32) in the covered lens (31).
• Fig. 4 c shows how eye II finds an index point II (37) through the lower edge slit (35) of the covered lens (33).
• 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 (33). At this point 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.
• the uncovered eye is fixed on an index point I at eye level when the head is in its upright position.
• the index point I is fixedly devised 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.
• FIG. 5 An alternative embodiment of a angle setting device (4) which indicates the specific angle of inclination (2) 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 (12).
• the angle setting device (4) 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 (4) comprises an angular support (39) which at one end ends with the yoke (38) and at the other end has an abutting face (40), 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 (2) and the arm consequently forms an inclinometer.
• the outer end of the arm (41) is provided with a marking (42), such as a colour marking.
• a pendulum (43) is pivotally connected to the inner end of the arm (41) on an axis (44), said pendulum (43) forming a plumbline indicator.
• the outer end of the pendulum (43) is provided with a marking (45) corresponding to the marking (42) of the arm.
• the yoke (38) 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 (40) 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 (10) can be compressed and the solution can be pumped into the nasal cavity.
• 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 (2) has been attained.
• the angle of inclination (2) 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 (46).
• the container is connected to the nasal olive (12) via a flexible tube (47).
• the container (10) In order to pump the solution up to the nasal cavity, the container (10) is held above the level of the nasal cavity so that when air is introduced through the vent aperture (46) the solution is able to flow from the higher positioned container (10) through the tube (47) and the nasal olive (12) and further up to the nasal cavity (1).
• 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.

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• Health & Medical Sciences (AREA)
• Otolaryngology (AREA)
• Epidemiology (AREA)
• Pain & Pain Management (AREA)
• Physical Education & Sports Medicine (AREA)
• Rehabilitation Therapy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)

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• 1987
  • 1987-11-30 SE SE8704768A patent/SE459713B/sv not_active IP Right Cessation
• 1988
  • 1988-11-24 WO PCT/SE1988/000640 patent/WO1989005163A1/en not_active Application Discontinuation
  • 1988-11-24 EP EP88910424A patent/EP0397666A1/en not_active Withdrawn
  • 1988-11-24 JP JP63509490A patent/JPH03501222A/ja active Pending
• 1990
  • 1990-05-29 FI FI902680A patent/FI902680A0/fi not_active IP Right Cessation
  • 1990-05-30 DK DK133790A patent/DK133790A/da unknown

Non-Patent Citations (1)

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