JPH03501222A - A device that injects a solution into the nasal cavity - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] A device that injects a solution into the nasal cavity field of invention The present invention relates to a device intended for injecting solutions into the nasal cavity. Moreover, the present invention relates to the use of devices for injecting solutions into the nasal cavity and methods of injecting solutions into the nasal cavity. Ru.

E-milk Yui" The nose with nasal cavities is formed by the nasal turbinates that hide the small openings leading to the sinuses at the back. It has a complex anatomy due to its intricate pattern. Drops, spray Topically administered drugs that are introduced into the nostrils as powders or powders are primarily Reach only those parts of the mucous membrane facing the. From research on drug distribution, The agent is transported along the closest path from the application site to the pharynx by the action of mucociliaries. It has been found that the exhaled dose is not distributed throughout the nasal mucosa due to Ru. Deep nasal breathing also makes a small contribution to a better local effect on the mucous membranes. stomach. The reason for this is that when you inhale, the air forms a laminar flow, which mainly occurs in the lower part of the nose. It has been observed that only minutes pass. Diseases of the mucous membranes of the nose affect the entire area of \u200b\u200bthe mucous membranes. If the drug treatment does not reach the entire affected area, it will not be effective by itself. Pharmacological substances that have no clinical effect. For example, vasomotor rhinitis Topically administered drugs for allergic rhinitis and congestion of the nasal ostia The insufficient pharmacological effect of drugs is due to the fact that drugs are limited to limited areas of the mucosa and It is due to reaching .

In connection with diagnosis, treatment and research, it is necessary to measure the effect of treatments on mucosal hyperemia. There is a point. True force measurement, i.e., measurement of airflow through the nose, is a measure of the effectiveness of the treatment. This is the most widely used method for measuring This method is expensive Because it is difficult, clumsy and requires computer-assisted calculations , used only in large hospitals. Peak flow measurements through the nose are Another, simpler method for determining the be.

``The device, which is shaped like a duck, fits snugly into the nostril. For irrigating, cleaning and moistening with the nasal olive. It was asked about this. The patient places a finger in the hole in the container, thereby allowing air to enter the container. Adjust the flow of the cleaning fluid by adjusting. This device allows irrigation fluid to enter the pharynx. It has been found that patients experience discomfort when using the product because regurgitation occurs in the body. the Moreover, the cleaning fluid cannot reach the entire mucous membrane.

Therefore, the patient can apply pharmacological solutions or drugs to the entire mucous membrane within the nasal cavity without feeling any discomfort. or irrigation fluid to reach a high level of medicine or Irrigation cleaning and humidification. It is necessary to find simple methods that are effective. Also, changes in mucosal volume There is a need for a simple and effective method of measuring the volume of the nasal cavity. .

Summary of the invention It is an object of the present invention to substantially remove the solution from the nose without creating a risk of the solution flowing downward into the pharynx. To provide a device capable of injecting a solution throughout the cavity. The goal is to solve the following problems.

According to the invention, a device of the type described herein as a starting point fits tightly into the nostril. A solution with a matching olive-like member (nasal olive) is pre-injected. container and the angle of patient head tilt required to inject the solution into the nasal cavity. and a device for pushing the solution from the container into the nasal cavity. It is said that

The invention also includes the use of the above-described device and a method of injecting a solution into the nasal cavity.

Other advantageous features of the invention are found in the following description of embodiments of the invention and in the claims. It will be clear from the dependent claims.

The present invention improves the connection between the nasal cavity and the pharynx when the patient's head is tilted approximately 60" from an upright position. such that the level or border of the nasal septum is placed at a higher level than the medial end of the septum. Based on the nasal anatomy with morphology. the patient's head was held in this position Sometimes the solution is introduced through the fluid-tight nasal olive, and half of the nasal cavity is connected to the upper nasal conch. All but a small volume above the cavity is filled with solution. Solution inject in excess It then overflows from the medial end of the nasal septum and flows out through the side nostrils. Therefore, the solution does not flow down into the pharynx.

According to the invention, the angle setting device prevents the solution from entering the pharynx, which is extremely unpleasant for the patient. This allows the solution to be optimally injected into the nasal cavity without the risk of regurgitation. Control the position of the patient's head.

The present invention is useful for the administration of drugs, such as mucosal decongestants, or for irrigation and It can be preferably used for humidification purposes. Additional fields of application of this device is a so-called nasal cavity volume measurement in which the volume of the mucous membrane, e.g. change in thickness, is measured. Ru. Other fields of application are also possible within the scope of the invention.

If the solution consists of a pharmacological solution, hidden parts of the nasal cavity, e.g. The drug reaches small pores that solutions cannot reach with prior art methods, thus A fully satisfactory effect of the agent can be obtained. This device has a device that forces the solution into the nasal cavity. The system keeps the solution moving by pumping it back and forth. This has the advantage of effectively irrigating and cleaning the mucous membranes. If the solution is a drug solution drug concentration and intranasal solution exposure time to local effects on mucous membranes. It is crucial for the absorption of the drug by the body and the patient's whole body.

The device according to the invention is suitable for measuring changes in the thickness of the mucous membrane within the nasal passages. child These measurements are simple and painless for determining the effectiveness of mucosal decongestant treatments. It is also an inexpensive method. The nasal cavity is theoretically a hole with a rigid outer bony cartilaginous wall. can be compared. The internal volume of the cartilage wall is constant and two components, i.e., filled with mucous membranes and air. mucosal volume and air Volume-to-volume ratios influence body position and movement as well as allergic effects and vasomotor regulation. Continuously changing depending on the action. When measuring the effect by measuring nasal cavity volume, The difference in measured volume corresponds to a change in mucosal volume.

Other fields of application of the device according to the invention are for different types of cleaning purposes, e.g. Cytological, enzymatic and histamine evaluation in relation to therapy and specific cancer forms. This includes irrigation and irrigation of the nose. This equipment is also suitable for use by workers in dusty environments. It can also be used for irrigation cleaning purposes for workers and craftsmen.

In tests carried out to determine the limits of the patient's head tilt, inter alia: At what angle the solution flows back into the pharynx instead of flowing over the medial end of the nasal septum was tested. It was confirmed that the restricted angle is slightly different for men and women. Tess The medial end of the nasal septum is all lower than the connection between the nasal cavity and the pharynx in the test, so that the solution passes through the pharynx. It was found that there was no risk of overflow. The patient may also use some type of assistive device. It has also been found that it is difficult to estimate head inclination on your own without using it.

An embodiment of the device for injecting a solution into the nasal cavity according to the present invention and modified embodiments thereof are attached. The accompanying drawings will be described in detail below.

FIG. 1 shows a cross-sectional view of a nasal cavity injected with a solution and a first embodiment of the invention; Figures 2a and 2b are cross-sections of a second embodiment of the invention in two different angular positions. Show a side view, Figures 3a and 3b are cross-sections of a third embodiment of the invention in two different angular positions. Show a side view, 4a to 4d show another embodiment of the angle setting device, FIG. 5 shows an additional embodiment of the invention, and FIG. 6 shows an alternative embodiment of the container.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION FIG. 1 shows a nasal cavity (1) of a patient, and inside the nasal cavity (1) there is provided a first embodiment of the present invention. More solution (3) is being injected.

The patient's head is bent from an upright position to a specific angle of inclination (2) and the patient's head is angled It is held in a particular angular position by a device (4). The angle setting device (4) is located at the outer end. It is equipped with two horizontal holders (5) with suction cups (6) on the sides.

The suction cup (6) is adapted to be pressed against a vertical wall (7), for example a mirror. There is. In order to hold the patient's head in a predetermined angular position, three different impact surfaces (8) It is arranged and shaped to conform to the face. These different impact surfaces (8) impinges on the patient's forehead, upper lip and chin. Two side impact surfaces (9) (one of them (only shown in Figure 1) is in contact with the cheekbone and the patient's head is placed on the side. It is designed to be fixed from

In the compressible disposable container (IO), for the purpose of injecting the solution into the nasal cavity, The solution (3), e.g. physiological saline or pharmacological solution, is initially filled. Ru. The volume of the solution in the container (10) ranges from lO to 18IIlQ depending on the individual. Preferably, the volume is slightly larger than the volume of the nasal cavity, which varies within the nasal cavity. The container (10) is At its opening (11) it is provided with an intranasal olivary member (12). The above The rib-like member (12) is attached to the nose when inserted into different sized nostrils (3). It has a conical shape to fit tightly into the inner surface of the hole. of different sizes In order to achieve a sufficient sealing effect in the nostril, the base of the olive-shaped member (12) of the device is The diameter of the bottom should be between 15mm and 23mm, preferably 19m+++. while the smaller diameter at the top should preferably be approximately 7π thick. container In order to prevent the solution in (10) from being sprayed into the nasal cavity (1), meaning that the opening of the intranasal olivary member (12) has a diameter of at least 4!11211 It is essential to have sufficient size to

Figure 1 shows that the solution (3) has entered the nasal cavity (1) to the same level as the inner end of the nasal septum (14). The mode of injection with a pump is shown. As can be seen from Figure 1, this level At the angle of inclination (2) set by the degree setting device (4), the nasal cavity (1) and pharynx (1) 6) is lower than the level of the boundary (15) of the connection between. Additional solution is added to the nasal cavity (1 ), excess solution crosses the inner end of the nasal septum (14). into the other nostril, thereby avoiding extremely unpleasant overflow into the pharynx. . The solution is pumped into a flexible container CIO and then removed from the container (10). It can be kept in a moving state by sending it out from the ground.

To measure changes in the volume of the nasal mucosa, the container (10) is compressed to remove all the solution. The fluid (3) is forced into the nasal cavity (1). Excess solution flows out through the other nostril do. Any solution still remaining in the nasal cavity (1) can be sucked back into the container (10). The volume of solution removed and retained is measured by weight. This is a container (10) This can be easily done by providing an indicator scale. Affects mucous membrane hyperemia. After 5ffii with a locally active pharmacological solution, the measurement procedure is Repeated. The difference between the two volumes is a measure of the efficiency of the pharmacological treatment.

゛ Figures 2a and 2b show that the angle setting device (4) and container (lO) are in one A second embodiment of the present invention configured as a composite device is shown. Figure 2a is in the upright position. The device is shown and Figure 2b shows the patient's head bent forward at approximately 60° in position I; This shows the equipment used. Position the composite device to match the device inclination to the patient’s head inclination. The position must be fixed in relation to the position of the patient's head. This fixation allows the container to be This can be done with a fixation device (not shown) that keeps it fixed on the head of the patient. another In embodiments, the outer model surface (17) is positioned relative to the patient's face to fix the position of the composite device. The contact surface can be configured as follows.

A compressible container (10) is inserted into the nasal cavity via a rigid conduit (18) within the composite device. It is connected to the tab-shaped member (12). A valve between the container (10) and the conduit (18) 19) is a valve body (20) having a bottom portion (21) sloping toward the connection with the pipe; It consists of

The connection of the pipe to the valve body (21) constitutes the valve seat of the ball valve (22). In Figure 2 In this position, the bottom (21) has an angle of inclination of about 50'' with respect to the horizontal plane. There is.

The container (lO) prefilled with solution is placed in its first position (see Figure 2a). , closed by valve (19). The intranasal olivary member (12) is connected to the patient's nostril. (13) When the composite device is introduced into the patient's head and the composite device is secured to the patient's head, the patient Bend the head forward until the device assumes the position shown in Figure 2b. Inclination angle in this case is approximately 60°. At this angle, the valve seat (22) will move due to the action of gravity. (21) rolls out from its position within the vessel (lO) and the intranasal olivary region. The connection between the material (12) is opened. In this condition, the patient may experience problems when the solution enters the pharynx. Certain drugs can prevent reflux and fill virtually the entire nasal cavity with solution. As long as the tilt angle is maintained, the solution is pumped between the container (10) and the nasal cavity (12). It can be sent freely for any purpose.

The variant embodiment of FIGS. 2a and 2b is connected to a visible container and includes an intermediate valve. It has an intranasal olive-like member. In this case, the container should be placed with the opening facing upward. It is placed below the valve body with the One or more conduits connect to the opening of the container. connected to the valve body, extending to and around the valve body and communicating with the valve body from above. tied. This valve is the same as the valve shown in Figures 2a and 2b, i.e. , this valve has a heavy earthenware and a valve body with a sloped bottom. valve tilt The bottom part is connected by a curved tube to an intranasal olivary member placed above the valve. It is connected. Therefore, when the container is compressed, the solution will flow past the valve body. Flows upward through the conduit and downward into the valve towards the sloping bottom . When the composite device is in the upright position, the dotan closes the connection with the pipe, while the composite device When the dotan is at an inclined position that matches the desired angle of inclination, the dotan will move due to the action of gravity. It rolls out of the closed position thereby opening the connection with the intranasal olivary member.

Figures 3a and 3b show that the angle setting device (4) and the container (lO) are connected to the combined device. Another example of the configured device is shown. The apparatus is shown in FIGS. 2a and 2b. and a device (not shown) for immobilization with respect to the patient's head in the same manner as the embodiment by They are meant to be combined.

A compressible container (lO) prefilled with solution is connected via two conduits (23, 24). and is connected to the intranasal olivary member (12). One of the conduits (23, 24) (23) is formed large. Inside the large conduit (23) there is a floating Dotan (25) is placed.

The upper branches of the two conduits (23, 24) are approximately 56 inclined. These branch pipes are then joined and connected to the neck (28). There is. The neck (28) terminates in the intranasal olivary member (12). large formation The curved conduit (23) is curved to join the upper branch pipe, and the conduit has a bent portion (29). ) is formed.

The container (10) is in the upright position according to Figure 3a (indicated by dashed lines in Figure 3a). When compressed, Dotan (25) floats with the rising liquid level and forms an intranasal olli. Close the connection with the tab-shaped member (12). The container (10) is tilted according to FIG. 3b. position (approximately 60° in the slope); The flow flows beyond the shape part, and the dotan (25) flows from the constriction of the neck (28). carried away and pressed against the bend (29) by the rising liquid level, thereby The connection between the container (10) and the filling olive (12) is opened and the required angle of inclination is will remain open as long as the

An angle setting device adapted to indicate a particular angle is shown in Figure 4a. this The angle setting device adjusts the angle between the upper part of the ear and the base of the nose when the patient's head is in an upright position. The line between them is horizontal and the distance between the upper part of the ear and the base of the nose is different. It is based on the recognition that it is essentially constant for people. Both angle setting devices Consists of glasses modified to be shielded except for a thin slit in which the lens of ing. From Figure 4a it can be seen that one lens has a narrow central slit (32) and the other One lens has one upper edge slit (34) and one lower edge slit (35). Understand that you are prepared.

How to use the glasses modified according to Figure 4a is shown in Figures 4b to 4d. Ru. The patient should not wear glasses when the head is in an upright position to adjust to the initial position. Stare at objects at eye level. occluded by eye I when wearing glasses Through the center of the lens (31) and the lift (32), focus on the index point I (36). (See Figure 4b). Figure 4C is below the lens (33) shielded by the eye The method of inserting the index point I+ (37) through the edge slit (35) is shown. Figure 4b , the index point II is located within the upper edge slit (34) of the shielded lens (33). You can see how the patient's head is bent until (37) is visible. child position, the patient's head is positioned for optimal effect for injecting fluid into the nasal cavity. The angle of inclination is maintained at the required angle.

If only one lens is shielded and an upper edge slit and a lower edge slit are formed. The distance between these two slits is slightly smaller than that in Figure 4a. In this case, a variant embodiment of the spectacles with a simpler form is obtained.

First, measure eye level with the patient's unoccluded eye when the patient's head is in an upright position. Fix it so that you can see the indicator work. Then, insert the index dot through the upper edge slit. At the same time, look at another index point ■ through the slit at the bottom edge.

The patient can then stare at the index point through the upper rim slit. Bend your head until it looks like this. The required angle of inclination is then obtained.

Another embodiment of the angle setting device (4) for indicating a specific angle of inclination (2) is shown in FIG. It is. This angle setting device is used in this case if a specific angle of inclination has not yet been obtained. It is shown in the correct position.

This device is fixed to the neck between the compressible container (10) and the wedge olive (12). It is equipped with an angle setting device. The angle setting difference R(4) is the elastic yaw It is fixedly attached to the container by a hook (38). The yoke (38) is a container ( 10) can be attached to and removed from the neck.

The angle setting device (4) includes a chevron-shaped support member (39).

The chevron-shaped support member (39) has a yoke (38) at one end and a shock at the other end. It has a contact surface (40). The impact surface (40) is formed in a shape that matches the face. Ru. An arm (4]) is fixedly connected to said other end. Arm (4 1) in the vertical plane of the patient's head (in its upright position) consistent with the inclination angle (2) As a result, the arm (41) constitutes an inclinometer. a The outer end of the arm (41) is provided with an indicator (42), for example a color indicator. arm A pendulum (43) is pivotally connected to the axis (44) at the inner end of (41). There is. The pendulum (43) constitutes a vertical line indicator.

The outer end of the pendulum (43) has a mark (45) corresponding to the mark (42) on the arm (41). ).

When using the device according to Figure 5, the yoke (38) is pushed around the neck of the container. The olive (12) is inserted into the nostril (13) and the abutment surface (40) collides with the patient's forehead.

The patient matches the mark (45) on the pendulum (43) with the mark (42) on the arm (41). Bend your head forward until. In this position, the container (10) can be compressed. And the solution can be pumped into the nasal cavity (1).

However, other types of angle setting devices are also contemplated within the scope of the invention. example For example, a pivotable plumb line indicator displays different colored indicators depending on the particular tilt angle. and display a green sign, for example, when the required angle of inclination (2) is reached. can be shown. The angle of inclination (2) is also determined by the sound signal generated by the battery or can be instructed by an optical signal.

Figure 6 shows an embodiment of an incompressible container (10) with ventilation 1:) (46) . This container (10) is connected to the intranasal olivary member (12) via a flexible tube (47). is connected to. A container (lO) for pumping the solution into the nasal cavity (1) is held above the level of the nasal cavity (1) so that air can pass through the vent (46). The solution is placed in a higher position when introduced into the tube (10) from the container (10). 47) and the utensil olive (12), and further flows to the nasal cavity (1) . To return the solution into the container (10), place said container (10) at the level of the nasal cavity. downwardly, thereby causing the solution to flow back into the container (10) and allowing air to pass through the vent (10). 46) into the outside air.

FIG 2b JF self) α1 Submission of translation of written amendment (Article 184-7, Paragraph 1 of the Patent Act) May 29, 1990

Claims (14)

[Claims] 1. a container (10) prefilled with a solution and fitting tightly within the nasal cavity; an angle setting device for setting the tilt angle (2) of the patient's head necessary for injecting the solution; and a device for pushing the solution from the container (10) into the nasal cavity (1). A device that injects a solution into the nasal cavity. 2. A container (10) pre-filled with a solution transfers the solution from the container (10) into the nasal cavity (1). preferably in the form of a bellows to enable pumping into the Device according to claim 1, characterized in that it is compressible. 3. The container (10) prefilled with the solution is rigid and has a vent (46). and is connected to the intranasal olivary member via a flexible tube (47) to allow the solution to flow Place the container (10) into the nasal cavity (1) in order to push it from the container (10) into the nasal cavity (1). Claim 1 characterized in that it can be lifted higher than the bell. The device described. 4. The angle setting device (4) can be fixedly attached to the patient's head and the angle setting device (4) can be fixedly attached to the patient's head and The setting device indicates the required tilt angle (2) of the patient's head for injecting the solution into the nasal cavity. According to any one of claims 1, 2 or 3, characterized in that: The device described. 5. The angle setting device (4) is connected to the container (10) by means of a coupling device (38) and to the impact surface ( 40) can be fixedly attached to the patient's head, said coupling device (38) and each of said abutting surfaces (40) on a respective end of the chevron-shaped support member (39). 5. A device according to claim 4, characterized in that: 6. An inclinometer (41) is attached to the chevron support member (39) and the patient's head is positioned at the required position. said inclinometer (41) is pivotable to said inclinometer when tilted to an angle of inclination (2); 6. Device according to claim 5, characterized in that it is matched with a connected pendulum (43). 7. The angle setting device (4) has an impact surface (8, 9) against the patient's head and is rigid. It consists of a stand that can be fixedly attached to a surface (7), said stand to fix the patient's head at the required angle of inclination (2) to inject the solution into the nasal cavity. 4. A device according to claim 1, 2 or 3, characterized in that it is capable of: 8. An angle setting device (4) is located between the container (10) and the intranasal olivary member (12). a valve (19; 25, 28), the valve is opened at a predetermined angle of inclination, and the container is The person's head is bent to the angle of inclination (2) necessary to inject the solution into the nasal cavity (1). Claim 2, wherein the valve is fixed to the patient's head so as to be opened when the valve is opened. The device described in. 9. The angle setting device (4) is shielded except for the thin slits (32, 34, 35). glasses having lenses (31, 33), one lens (31) having a central slit; (32) and the other lens (33) has an upper edge (34) and a lower edge (35). 5. Device according to claim 4, characterized in that it has a slit in ). 10. The angle of inclination required to inject the solution into the nasal cavity is in the range of 55° to 90°. 2. Device according to claim 1, characterized in that the angle is within 60[deg.]. 11. A pharmacological solution in which a container (10) prefilled with the solution is administered intranasally. According to any one of claims 1 to 10, the container contains a Use of equipment. 12. Push all the solution in the container (10) into the nasal cavity (1) thereby removing excess A volume of solution is allowed to overflow into the lateral nostrils, and then the remaining amount is used to measure the intranasal volume. Claim 1 characterized in that the solution is sucked back into the container (10). Use of a device according to any one of claims 1 to 10. 13. Subsequent measurements are used to measure changes in the volume of the mucous membrane within the nasal cavity (1). 13. The device according to claim 12, characterized in that: 14. The patient's head is within a range of 55° to 90°, preferably 60° from an upright position. ° Bend forward so that the wall between the two nasal cavities forms the connection between the nasal cavity and the pharynx. intranasal olivary shape that holds the solution below the level and then fits the solution into the nostril Pushed into the nasal cavity (1) from the container (10) with the member (12), i.e. the port A method for injecting a solution into the nasal cavity, which is characterized by delivering the solution by pumping action.