WO1994007419A1

WO1994007419A1 - A device for collecting saliva from a patient

Info

Publication number: WO1994007419A1
Application number: PCT/SE1993/000792
Authority: WO
Inventors: Åke NORDLUND; Thorild Ericson
Original assignee: Nordlund Aake; Thorild Ericson
Priority date: 1992-10-02
Filing date: 1993-10-01
Publication date: 1994-04-14
Also published as: SE9202875D0; SE470476B; EP0664685A1; AU5123593A; SE9202875L

Abstract

A device for collecting saliva from the parotid glands of the mouth. In order to eliminate the need of subpressure or other auxiliaries to anchor known devices for the intended purpose, the inventive device includes a generally bulbous body (2) which has a greater extension in its longitudinal direction than in its transverse direction. The bulbous body is provided with a collecting chamber (4) which has an inlet opening (6) located on the upper side of the body. The largest cross section of the bulbous body is in a plane which passes through the opening (6), and the body includes three external surface regions (7, 8, 9). When seen from above, two (7, 9) of these surface regions are convexly curved while the third region (8) is concavely curved. The surface regions are intended respectively for coaction with the teeth (19) of the upper and the lower jaw, or the upper and the lower jawbone (20), masseter muscle and orbicular muscle of the mouth, in a manner to fixate and hold the device inserted in a patient's mouth in a correct position in relation to the gland.

Description

A DEVICE FOR COLLECTING SALIVA FROM A PATIENT
The present invention relates to a device for collecting saliva from the parotid glands in the mouth.

There are several examples by means of which it is possible to show and even to prove the potential significance of saliva in enabling oral risk states to be determined or ascertained by analyzing buffer systems, electrolytes, proteins, lipids, carbohydrates and important biologically active defense systems which protect mucous membrane from external attack, and of steroid hormones, among other things. Examples that can be mentioned include the analysis of immunoglobulins and other antibacterial substances in saliva, the analysis of saliva composition in various systemic diseases or illnesses, the analysis of medicine for dosage testing, etc.

The possibility of using saliva samples for diagnostic purposes is often based on the prerequisite that saliva can be collected directly from glands. There is without doubt a serious need to be able to take such saliva samples without contaminating the sample with the undefined mixture of secretion that normally occurs in the mouth. This secretion mixture will often contain food residues and at times blood emanating from the gums. The possibilities of using saliva analysis for diagnostic purposes for instance has been greatly limited, however, by the equipment and technology hitherto used for sampling saliva from individual saliva producing glands, for instance the parotid gland, this procedure being much too complicated technically even for the experienced person.

Naturally, one prerequisite is not to allow mixed secretion in the mouth to mix with the saliva sampan when wishing to study secretion from the parotid gland, for instance.

When practicing known methods, the collection of saliva from the parotid gland requires access to relatively complicated equipment, either for cannulation of the gland exit channel or to produce the vacuum, i.e. a subpressure, that is necessary in achieving tight sealing of the actual saliva-collecting body around the gland orifice. Examples of such bodies include the so-called "Lashely cup", (Lashely,
K.S.: Reflex Secretion of the Human Parotid Gland, J.

Exp. Psychol. 1:461-496, 1916), also referred to as the "Carlsson-Crittenden body", (Carlsson A.J. and
Crittenden A.L.: The Relation of Ptyalin Concentration to the Diet and to the Rate of Secretion of the
Saliva, Am. J. Physiol. 26:169-177, 1910). In order to be able to utilize this known equipment, which is not available commercially, in the manner intended, it has been found necessary in practice to establish or create saliva sampling stations which are provided with the requisite equipment and to which one is more or less referred in order to be able to take saliva samples from a patient.

This makes the task of taking saliva samples complicated and restricts the sampling of saliva to certain institutions, which is to some extent the reason why saliva samples are not taken to the extent that is actually desirable in view of the potential significance of saliva in prognosis and diagnosis in respect of health and illness (sickness).

Neither are these known methods suitable for epidemiological studies, since it is often necessary to carry out such studies in the field under primitive conditions.

Simpler devices for collecting or sampling saliva are known to the art. These devices could well be suited for use when sampling saliva, if it were not for the fact that these devices are unable to seal effectively around the gland orifice, resulting unfailingly in contamination with the mixed secretion normally present in the mouth. One such known device is described in U.S. Patent Specification 4,114,605 and is made of a plastic material and includes a flat, circular part having a relatively large base surface and a domed part which is connected sealingly thereto. The flat part and the domed part together enclose a saliva-collecting chamber, and there is provided in the upper half of the flat part of said device an inlet opening which is intended to be placed over the orifice of the gland from which saliva shall be collected.

The domed part can be compressed slightly with the intention of creating a subpressure in the salivacollecting chamber and its input opening, so as to suck the device firmly around the gland exit channel of the gland. Because of the relatively large base surface of the device, this surface functioning as an abutment surface with the cheek area around the gland exit channel, it is difficult to achieve with this known device sealing abutment around the inlet opening, therefore creating a high degree of uncertainty when using the device and creating a high risk of contamination with the mixed secretion present in the mouth.

Accordingly, it is an object of the present invention to provide a device for collecting saliva from parotid glands that has none of the aforesaid drawbacks of known devices and which is so constructed as not to require auxiliaries in the form of vacuums, clamps or other means for holding the device firmly in position and which, nevertheless, will seal tightly around the gland orifice so that saliva collected from the gland in the device will be prevented from mixing with mixed secretion present in the mouth. Another object is to provide a device that can be readily handled and applied, so that in principle anyone will be able to apply the device and so that the device will always be brought to a correct position in relation to the gland orifice when the patient closes his/her mouth and also into sealing engagement around the gland orifice at the same time.

These and other objects of the invention are achieved with a device having the characteristic features set forth in the following Claims.

The invention will now be described in more detail with reference to the accompanying drawings, in which
Fig. 1 illustrates a preferred embodiment of an inventive device from above and shows the device generally in the position that the device should take when inserted into the mouth of a patient for collecting secretion from the right-hand parotid gland; Fig.2 is a sectional view taken on the line I-I in Fig. 1;
Fig. 3 is a sectional view taken on the line II-II in
Fig. 1; Fig. 4 is a front sectional view through a cheek part at the first molar on the right-hand side;
Fig. 5 is a sectional view similar to the view of Fig.

4, but with the collecting device shown in the section shown in Fig. 3 and inserted into position for collecting saliva from the parotid gland; Fig. 6 illustrates the position of the collecting device 2 in the mouth of a patient; Fig. 7 illustrates the regional muscles and the action of these muscles; and Fig.8 is a horizontal sectional view of the device in relation to the regional muscles.

The inventive device includes a body 1, which is preferably solid but not necessarily so, as illustrated in the drawings. The body 1 has the form of a vessel 2 having an irregular, rounded and slightly extended bulbous configuration 2a. Although not necessary, the vessel 2 may include a part 2b which is extended from the vessel part 2a and which narrows to form a grip 3 which facilitates insertion and removal of the device into and out of the mouth of a patient.

In the illustrated case, the narrowing grip 3 has the added function of increasing the stability of the device when inserted into the mouth of the patient in a saliva-collecting position, and for this reason it is more beneficial to provide the device with such a grip 3 than not to include the grip. The configuration of the grip is also significant to the function of the device as a saliva-sampling or saliva-collecting device, and the position of the grip in relation to the bulbous part 2 and extension in relation to the section plane I-I will preferably be that illustrated in Fig. 1.

The bulbous part 2a of the device includes a normally conical saliva-collecting chamber 4 having an inlet opening 6 located in the upwardly facing surface 5 of said part 2a. The opening is made sufficiently large to surround positively the orifice 15 (see Figs. 4 and 5) of the gland from which saliva is to be collected.

For instance, the chamber inlet opening 6 may have a diameter of 9-17 mm and preferably about 13 mm. The inlet opening 6 and the inwardly lying chamber 4 are placed in the broadest part of the bulbous vessel 2a, as seen in a projection to the plane of the drawing in
Fig. 1. The chamber 4 may have any desired shape, including a cylindrical shape, inwardly of the inlet opening 6, and the section lines or section planes I-I and Il-Il in Fig. 1 will mutually intersect in the centre of said opening 6.

The inventive device is intended for collecting saliva from a parotid gland, the orifice 15 of which normally discharges in the cheek 16, between the covering folds 17, 18 and closer to the upper fold 17 than the lower fold 18 (see Fig. 4), and is intended to be placed in the mouth of a patient between the rows of teeth 19 in the upper and lower jaw, or if the patient has no teeth between the upper and lower jawbones 20.

In order to ensure that the collecting device will always be positioned correctly in relation to the parotid gland orifice 15 when inserted into the mouth of a patient, the vessel part 2a of the device is provided with a first surface region 7 for coaction with the teeth 19 or the jawbones 20, a second surface region 8 for coaction with the rear edge of the orbicular mouth muscle (5 in Figs. 7, 8) and a third surface region 9 for coaction with the front edge of masseter muscle (2 in Figs. 7, 8) and with a buccinator muscle (4 in
Figs. 7, 8).

In the projection illustrated in Fig. 1, the surface region 7 of the vessel part is convex arcuate or rounded, and to some extent also in a vertical direction (Figs. 3 and 5), although less pronounced, and when seen in Fig. 1 includes an angle of up to 75-800 covering the angular range approximately from the section line II-II in Fig. 1 in a direction towards the grip 3 with an increasing radial distance in said latter direction from the intersection point 25 of the section lines shown in Fig. 1, this point of intersection being located in the centre of the opening 6 as before mentioned.

When seen vertically, the surface region 7 includes surfaces 10 and 11 which are inclined or slope relative to one another and relative to the section plane I-I and which also define an obtuse angle therebetween, wherein the surface 10 is intended for coaction with the tooth row 19 or the jawbone 20 of the upper jaw and the surface 11 is intended for coaction with the tooth row 19 or the jawbone 20 of the lower jaw.

When seen in the projection shown in Fig. 1, the surface region 8 of the vessel part has a concave, inwardly swung form and is convexly rounded when seen vertically. The surface region 8 extends from the broadest part of the vessel part in a direction towards the grip 3 and covers an angular range which is smaller than an angle of 900, e.g. 750, and increases in radial distance in a direction towards the grip, wherein the largest radial distance of this surface region, seen in Fig. 1, from said intersection point 25 may be roughly the same as the corresponding distance of the surface region 7 from said intersection point 25, whereas its smallest radial distance is much shorter than the corresponding distance of the surface region 7 from said intersection point 25.

Thus, in the view shown in Fig. 1 the surface region 8 has the form of a support pocket for coaction with the rear edge of the orbicular muscle of the mouth (5 in Figs. 7, 8).

The third surface region 9 of the vessel part is located at the end part of said vessel distal from the grip 3 and extends on both sides of the section line
I-I in Fig. 1. The region 9 is arcuately convex both in the projection shown in Fig. 1 and also in a vertical direction, and covers an angular area within an angle of about 85-90 and has a radially increasing distance to the intersection point 25 from that outer edge of the surface region which is located nearest the surface region 8, and in a direction towards its other outer edge, wherein the radial distance to the intersection point 25 increases to a much lesser extent for the surface region 9 than for the two other surface regions 7 and 8.

The smallest radial distance of the surface region 9 from the intersection point 25 is approximately the same as the corresponding distance of the surface region 8, and its largest radial distance to said intersection point 25 is approximately the same as or possibly slightly smaller than the smallest radial distance of the surface region 7 to the intersection point 25, as seen in the projection shown in Fig. 1. That part of the surface region 9 which is located on the same side of the section plane
I-I as the surface region 7 is smaller than that part which is located on the other side of said section plane, i.e. on the same side of the plane as the surface region 8.

Fig. 1 illustrates the position that the inventive collecting device should have when inserted manually into the mouth of a patient and held by the grip 3 in the patient's open mouth, between the cheek and the teeth 19 of the lower and upper jaws so as to reach the forward edge of the masseter muscle (2 in Figs. 7, 8) which constitutes the rear limit position of the collecting device in the patient's mouth. The forward limit position of the collecting device in the patient's mouth is formed by the rear edge of the orbicular muscle of the mouth (5 in Figs. 7, 8) with which the support pocket formed in the surface region 8 of the collecting device is intended to coact.

Thus, when inserted in the mouth, the surface region 7 of the vessel part will face towards the teeth 19 in the lower and upper jaw, or if the patient has no teeth towards respective jawbones 20, and its surface region 9 will face the rear edge of the orbicular muscle of the mouth (5 in Figs. 7, 8), and the surface region 9 of the vessel part will face towards the forward edge of the masseter muscle (2 in Figs. 7, 8), wherein the grip 3 faces out towards the mouth opening and the opening 6 of the saliva-collecting chamber will be so inclined relative to the horizontal plane that its highest part will face towards the surface region 7 of said vessel part.

Subsequent to inserting the device, the mouth is closed by biting on the surface 10 of the vessel part with the teeth 19 or jawbone 20, and slightly later by biting on the surface 11 with the teeth 19 or the jawbone 20 of the lower jaw, so that the collecting device is rotated slightly in the direction of the arrow 24 in Fig. 3 to approximately the position shown in Fig. 5, primarily by the teeth 19 in the upper jaw. In the final stage of closing the teeth or jaw-bones, the collecting device is pressed against the cheek 16 by coaction of the teeth 19 or jawbone 20 of the upper and the lower jaw with the surfaces 10, 11, such as to cause the cheek to embrace the collecting device and position the gland orifice 15 over the opening 6 of the saliva-collecting chamber.

At the same time, the front edge of masseter muscle 2 (Figs. 7, 8) will come into active engagement with the surface region 9 of the vessel part and the rear edge of the orbicular mouth muscle (5 in Figs. 7, 8) will be brought into active engagement with the surface region 8 of the vessel part so as to fix and hold the collecting device, embraced by the cheek 16, in its intended position inside the mouth in cooperation with the teeth 19 or jawbone 20, provided that the mouth is held closed.

The inventive saliva-collecting device is thus held in position solely with the aid of the muscle groups in the mouth and thus without any form of artificial help, for instance help in the form of subpressure as has been usual with all known types of saliva-collecting devices, and is nevertheless held positively and securely in its intended position pressed against the region around the gland orifice 15 by said muscle groups (2, 5 in Figs. 7, 8) and also to some extent by the buccinator muscle (4 in Figs. 7, 8), as a result of its coaction with the surface regions 9 and 8 of the inventive device, the outer configuration of which is smoothly rounded in all directions, and has no sharp corners or edges that could be felt to be uncomfortable.

As a result of its shape, the inventive saliva-collecting device can be used generally, without needing to take particularly into account any variations in the teeth settings of an individual, for instance.

The surfaces 5 of the vessel part which face towards and conform to the chamber opening 6 are configured so as to form a relatively pronounced circumferential edge 12 which as the teeth are clenched around the device is pressed slightly into the flesh of the cheek around the orifice 15 of the parotid gland and which is thereby caused to seal highly effectively around the gland orifice 15 and the inlet opening 6 of the collecting chamber. This effectively prevents saliva from the gland being contaminated with mixed secretion from the mouth, thereby keeping the gland saliva collected in the chamber 4 pure.

For anatomical reasons, the inventive device is produced in two mirror-image versions, one for the right side and one for the left side, the illustrated version being intended for the right side, and each version is produced in two sizes, one for children and one for adults. This latter version is larger than the child's version, due to the greater distance between the covering folds 17, 18 in the upper and the lower jaw.

According to the invention, the device may also be provided with a drain which extends from the lower part of the collecting chamber 4 to the surface region 8, as indicated by broken lines 26 in Fig. 1. By connecting a plastic hose to the drain, larger volumes of saliva can be collected in a collecting tube connected to the end of the hose that lies outside the patient's mouth. Furthermore, a removable insert can be applied in the collecting chamber 4 for collecting saliva from a patient.

The collecting device will preferably be made of a material, for instance a soft plastic material, which is resistant to mouth liquids and which will withstand cleaning in at least 70% ethyl alcohol. It can be mentioned by way of example that the device has a length of between 3 and 5 cm, preferably between 3.5 and 4.5 cm, and a height between 1.5 and 3.5 cm, preferably between 2 and 3 cm. The broadest crosssection of the perimeter or circumference of the device, this broadest cross-section coinciding approximately with the section plane II-II in Fig. 1, will lie roughly between 11-7 cm, preferably between 10-8 cm, and the inlet diameter of the collecting chamber may be about 17-9 mm, preferably 13 mm.

It will be understood that the present invention is not restricted to the aforedescribed and illustrated embodiment and that changes and modifications can be made within the scope of the inventive concept defined in the following Claims.

Claims

1. A device for collecting secretion (saliva) from the parotid gland in the mouth, characterized by an essentially bulbous body (2) which has a greater extension longitudinally than transversely and in which there is formed a collecting chamber (4) which has an inlet opening (6) located on the upper side of said body, in that the body has its largest crosssection in a plane that extends through said opening (6) and includes three external surface regions (7, 8, 9), of which two surface regions (7, 9) are curved convexly when seen from above, and the third surface region (8) is curved concavely for coaction with the teeth (19) or the jawbone (20) of the upper and lower jaw, masseter muscles (2 in Fig. 7) and orbicular muscle of the mouth (5 in Fig.

7) respectively in a manner to fixate and retain the device inserted in a patient's mouth in the correct position in relation to said gland.

2. A device according to Claim 1, characterized in that the surface region (7) intended for coaction with the teeth (19) is configured as a convex double-curve and is located on one side of the bulbous body, and in that the surface region (8) intended for coaction with the orbicular muscle of the mouth (5 in Fig. 7) is arcuately concave when seen in a first direction and is arcuately convex when seen in a second projection at right angles to said first projection and is located on the other side of the bulbous body; and in that the surface region (9) intended for coaction with masseter muscles (2 in Fig. 7) has a convex doublecurve configuration and is located on the forward end part of the device as seen in the direction in which the device is inserted into the mouth.

3. A device according to Claim 1 or 2, characterized in that the surface regions (7, 8) intended respectively for coaction with the teeth (19) and the orbicular muscle of the mouth (5 in Fig. 7) and formed on the sides of the bulbous body have the greater part of their extension in a longitudinal direction after the largest cross-section of the bulbous body as seen in the direction of insertion of the device.

4. A device according to Claim 1, 2 or 3, characterized in that the surface region (7) intended for coaction with the teeth (19) in the upper and the lower jaw of a patient have vertically mutually inclined upper and lower surfaces (10, 11) which define an obtuse angle therebetween; and in that the upper surface (10) is intended to coact with the teeth (19) of the upper jaw or with the jawbone (20), and the lower surface (11) is intended to coact with the teeth (19) of the lower jaw or the lower jawbone (20).

5. A device according to any one of the preceding Claims, characterized in that the bulbous body tapers to form a grip (3) in a direction away from the surface regions (7, 8) that are intended to coact with the teeth (19) and the orbicular muscle of the mouth.

6. A device according to any one of the preceding Claims, characterized in that in that in said first projection, in which the inlet opening (6) to the collecting chamber (4) is slightly inclined to a horizontal plane so that the highest point of the opening faces towards the surface region (7) intended for coaction with the top and bottom teeth (19), the smallest radial distance of the latter surface region (7) to the centre of the inlet opening (6) is greater than the smallest distance of the two other surface regions (8, 9) to said centre.

7. A device according to Claim 6, characterized in that the smallest distance of the two last-mentioned surface regions to the centre of the inlet opening are approximately the same.

8. A device according to Claim 6 or 7, characterized in that, seen in said projection, each of the three surface regions (7, 8, 9) is included in an angular range with an angle of approximately 900 or less, departing from the centre of said opening (6).

9. A device according to any one of the preceding Claims, characterized in that the surfaces (5) of the bulbous body adjacent the chamber inlet opening form in the vicinity of said opening (6) a relatively pronounced circumferential edge (12).

10. A device according to any one of the preceding Claims, characterized by an outlet channel (26) which extends from the collecting chamber (4) to the surface region (8) intended for coaction with the orbicular muscle of the mouth (5) and which functions to remove saliva from a device seated in the mouth.