WO1999007323A1

WO1999007323A1 - Vasoregulation device

Info

Publication number: WO1999007323A1
Application number: PCT/NL1998/000449
Authority: WO
Inventors: Frederikus Johannes SCHRÖER
Original assignee: Three Tees International Business Center
Priority date: 1997-08-11
Filing date: 1998-08-04
Publication date: 1999-02-18
Also published as: NL1008685C2; AU8752298A

Abstract

Vasoregulation device for use during the phase prior to headache, in particular migraine, for applying pressure at least locally to one or more veins on the outside of the head, in order to restrict the flow of blood through the said veins, at least comprising pressure-exerting means (8, 9). The device is thus intended for preventative use at the onset of migraine.

Description

Short title: Vasoregulation device

The present invention relates to a vasoregulation device for use during the phase prior to headache, in particular migraine.

Migraine is a periodically recurring headache which generally involves a very localized headache. Approximately 10% of the population suffers from a more or less serious form of migraine.

There are numerous forms of migraine, but generally a migraine attack consists of two important, distinct phases. There is a first pre-headache phase, often without pain, but with specific pre-headache symptoms, such as for example visual disturbances, including seeing coloured bubbles, lines and the like, or other disturbances, for example in hearing or the sense of taste or smell. Often, a spot of light, known as the "aura", is seen. Numbness or tingling of parts of the body, such as fingers, hands, lips and the like, also occurs.

In the case of the classical migraine attack, this pre-headache phase is accompanied by so-called vasoconstriction, which is a constriction of veins in the head, leading to a local increase in blood pressure.

In most cases, the pre-headache phase lasts for 5 to 30 minutes and disappears slowly together with the other pre-headache symptoms. While these symptoms disappear slowly, they are replaced by the actual headache itself, which is often unbearable. This headache has a number of frequently occurring side-effects, such as nausea, increased sensitivity to light, noise or odour, visual disturbances, diarrhoea, yawning, sweating and the like. During this headache phase, a so-called vasodilatation occurs, namely a widening of blood vessels in the head, resulting in a reduction in blood pressure.

Numerous techniques and medicaments are known from the prior art for counteracting migraine, but these all act in the headache phase. Thus, it is known, for example, to arrange belts or the like with increased tension around the head, possibly with discs positioned between them, during the headache, as is disclosed in US-A-5, 419 , 758 , or to administer medicaments which counteract the vasodilatation. None of the abovementioned methods or medicaments actually suppresses pain to a satisfactory extent. Also, it is undesirable to carry out treatments to the head of a patient during the headache phase, owing to oversensitivity to all external stimuli during the headache.

Surprisingly, it has been found that if the flow of blood to the head is reduced during the phase prior to the actual headache, very little or no headache occurs during the subsequent headache phase .

The present invention therefore provides a vasoregulation device for use during the phase prior to headache, in particular migraine, for applying pressure at least locally to one or more veins on the outside of the head, in order to restrict the flow of blood through the said veins, at least comprising pressure-exerting means.

By using the device according to the invention, it is possible, by restricting the flow of blood in certain veins on the outside of the head (on the outside of the skull) during the pre-headache phase, to substantially avoid pain completely during the subsequent headache phase. An important advantage of the device according to the invention is that headache is prevented without the use of a medicament.

In the present description, a vein is intended to mean both a blood vessel and an artery.

Preferably, the pressure-exerting means are designed to completely stop the flow of blood through the vein in question.

In particular, the pressure-exerting means are designed to apply pressure to at least one temporal vein, and preferably to both temporal veins. Most preferably, the pressure-exerting means are designed to apply the pressure to the temporal vein just above the ear, before it branches off into two smaller veins .

The way in which pressure is applied to the vein(s) in question is in no way limited and may be carried out in a wide variety of ways .

In a particular embodiment, the pressure-exerting means comprise massaging means for allowing the pressure- exerting means to carry out a massaging movement.

In practice, it has been found that if, during the application of pressure, the pressure-exerting means carry out a massaging movement, which may comprise any known massaging movement, such as vibration, rotation, rolling and the like, a very effective action of the device is obtained.

Research has shown that the average pressure which is required to restrict or eliminate the flow of blood through the veins in question is approximately 5 N, with a low scatter. It is preferable for this pressure which is to be applied by the pressure-exerting means not to be made adjustable by the user, since users have a tendency to apply an unnecessarily high pressure.

In a particular embodiment of the device according to the invention, the pressure-exerting means comprise a bracket with one or more pressure-exerting elements. Naturally, a bracket of this kind may be of any form which is suitable for allowing the pressure-exerting elements to apply the desired pressure. In particular, the bracket element forms part of a pair of spectacles, a set of headphones or a component thereof. Apart from these forms, consideration could also be given to a component of a face mask, shoulder supports, etc.

The number of pressure-exerting elements is not limited and may vary from 1 to even up to 10 pressure- exerting elements. Preferably, however, the device comprises two pressure-exerting elements, which are suitable for applying pressure to both temporal veins. The form of the pressure-exerting surface of the pressure-exerting elements will vary as a function of the particular vein to which pressure is to be applied. In particular, the pressure-exerting elements comprise a rounded pressure-exerting surface with dimensions which are slightly greater than the diameter of the vein to which pressure is being applied.

The material of which the pressure-exerting means are made is not particularly critical, but advantageously that section of the pressure-exerting means which comes into contact with the head at the location of the vein in question is made of soft, slightly resilient plastic material .

Particularly advantageously, that section of the pressure-exerting means which comes into contact with the head at the location of the vein in question, i.e. the pressure-exerting elements, are designed in such a manner that they are self-aligning. To this end, the pressure- exerting elements may, for example, be attached such that they can pivot in a number of directions. In a particular embodiment of the device according to the invention, the pressure-exerting means comprise two hinged arms, which are optionally directly coupled to one another, having pressure-exerting elements, it being possible for the arms to interact with spring means in order to provide the necessary pressure. This embodiment will be explained in more detail below with reference to the drawing. This concerns a headphone-type device which can be worn over the head, behind the head or under the chin. Preferably, the arms are hingedly coupled to a connecting support and the spring means comprise one or more springs. Particularly preferably, these springs are so-called constant-force springs. These are springs which, under load, create an approximately constant spring force. This can be realized by using a relatively long coil spring with a large number of turns . The arms may be coupled together with a spring between them, but may also each be coupled to the connecting support via a spring.

The invention will now be explained in more detail with reference to the appended drawing, in which:

Fig. 1 shows a diagrammatic view of a human head, showing the position of the temporal vein;

Fig. 2 shows a first embodiment of the device according to the invention, designed in the form of a set of headphones ;

Fig. 3 shows another embodiment of the device according to the invention, with a handle;

Fig. 4 shows yet another embodiment of the device according to the invention in the form of a pair of spectacles;

Figs. 5a-c show three embodiments of the pressure- exerting elements;

Fig. 6a shows a partially cut-away embodiment of the device according to the invention with two arms and a connecting support;

Fig. 6b shows a bottom view of the connecting support in accordance with Fig. 6a; and

Fig. 6c shows a side view of the connecting support in accordance with Fig. 6a.

Fig. 1 shows a human head with a temporal vein 1 on the left-hand side of the head. This vein runs past the front of the ear and, above the ear, splits up into two smaller veins 2 and 3, which respectively run towards the front and the rear of the head. The device according to the invention is preferably designed in such a way and is preferably used in such a way that it restricts the flow of blood in the temporal vein 1 at the location of 4. This restriction in the flow of blood (vasoregulation) according to the invention takes place during the so-called pre-headache phase, which in classical migraine is also known as the vasoconstriction phase. During this vasoconstriction phase, the blood pressure increases and, surprisingly, it has been found that an additional restriction in the flow of blood through the temporal vein considerably reduces the pain during the subsequent headache phase and often this pain does not occur at all. Fig. 2 diagrammatically shows a first embodiment of the device according to the invention. This device comprises two bracket elements 5 and 6, which are hingedly connected to one another at 7. Both bracket elements 5 and 6 comprise pressure-exerting elements 8 and 9, which can be displaced over the associated brackets 5 and 6 in order to ensure accurate positioning of the pressure-exerting elements 8 and 9 and in order to allow the device to be adapted as a function of the dimensions of the head of the user and the position of the relevant veins in which the flow of blood is to be restricted. The pressure-exerting elements 8, 9 may, for example, be positioned by means of clip-in notches on the bracket elements 5, 6.

10 denotes an adjustment screw which is coupled in a freely rotatable manner to a section 11 of the bracket component 6 and interacts with the section 12 of the bracket component 5, which has an internal screw thread, while the screw 10 has an external screw thread. This adjustment screw 10 can be used to adjust the pressure which the bracket elements 5 and 6 exert on the head and/or the vein(s) in question. The material of which the bracket elements 5 and 6 are made is not critical, but is preferably a slightly resilient material, such as for example plastic. The pressure-exerting elements 8 and 9 comprise rounded ends which are preferably made from a soft, slightly resilient plastic. Fig. 3 shows an amended embodiment of the device according to the invention with a handle 13. The handle 13 is an extension of the section 12 of bracket element 5. The presence of the handle 13 offers the advantage that the device is arranged not over the head, as in the embodiment in accordance with Fig. 2, but under the head. By taking hold of the handle 13, the user can move the device during use, thus exerting a massaging effect on the veins by means of the pressure-exerting elements 8 and 9, which improves the action of the device and thus the success in preventing headache.

The massage means may also be designed in other ways. Consideration may be given to vibrating elements, which are optionally directly driven by a motor or the like. Also, suitable means can be used to rotate the pressure-exerting elements or move them to and fro automatically, optionally at an adjustable speed.

Fig. 4 shows an embodiment of the device in the form of a pair of spectacles with a frame 14 and two arms 15 and 16. The pressure-exerting elements 8 and 9 are attached to the arms 15 and 16 and can preferably be displaced along the arms, so that they can be suitably positioned. If appropriate, the arms 15 and 16 could be connected to one another at the location of 17 and 18 (attachment behind the ears) , for example by means of an adjustable belt or the like, in order to regulate the pressure applied by the pressure-exerting elements 8 and 9.

The pressure-exerting elements may be designed in a very large number of ways. Preferably, these pressure- exerting elements are designed to be movable where they come into contact with the vein which is to be influenced. The pressure-exerting elements 8 and 9, as indicated in the figure, may therefore be designed, for example, in ballpoint form, in which case a spherical component can move freely in a bowl . It is not always necessary to use two pressure-exerting components, but rather it is also possible to use the device with only one component or with a plurality of components. This will depend on the wishes of the user. Figs. 5a-c show different embodiments of the shape of the pressure-exerting elements, these pressure-exerting elements being designed as small, freely rotating wheels with a central axle.

In Fig. 5a, the pressure-exerting element comprises a spherical wheel 19 with a central axle 20.

In Fig. 5b, the pressure-exerting element comprises a flattened wheel 21 with an axle 20.

Fig. 5c shows an embodiment of the pressure-exerting element with an axle 20 and two smaller spherical wheels 22. Numerous other designs of the pressure-exerting elements are conceivable and suitable for use in the device according to the invention.

Fig. 6a shows an embodiment of the device according to the invention comprising two arms 23 and 24 with pressure- exerting elements 8 and 9, which pressure-exerting elements comprise foam rubber caps which are connected to attachment components 25 and 26 such that they can pivot in various directions. These components 25 and 26 are in turn coupled to the arms 23 and 24, respectively. The device in accordance with Fig. 6a also comprises a sleeve-like connecting support 27, in which two pivot caps 28 and 29 are accommodated, which are coupled together by means of a constant-force spring 30. The pivot caps 28 and 29 each comprise an attachment sleeve 31 and 32, respectively, in which the arms 23 and 24, respectively, are releasably attached.

The pivot caps 28 and 29 furthermore comprise a stop collar 33 and 34, respectively, which interacts with the relevant opening of the connecting support 27. Furthermore, a coupling pin 35, one of which can be seen in the pivot cap 29, for coupling to the spring 30 is present in each pivot cap.

Fig. 6b shows a bottom view and Fig. 6c shows a side view of the connecting support 27.

In Fig. 6a, a force is applied to the arms 23 and 24 in the direction indicated by the arrows, with the result that the pivot caps 28 and 29 are tilted slightly under stress from the spring 30. Preferably, this spring 30 already has a slight prestressing in the at-rest position of the device.

It may be advantageous to place the attachment point 35 between the spring 30 and the pivot caps 28 and 29 on the other side of the arms in question. This allows any change in couple and associated clamping force which may occur to be minimized. All this lies within the scope of the average person skilled in the art. It is preferable to design the spring and the coupling between the spring and the pivot caps in such a manner that a substantially constant pressure is obtained when the device is used on different dimensions of human heads.

By designing the device according to the invention as shown in Fig. 6a, it can be stored in a spectacles case, since the arms 23 and 24 can be removed from the connecting sleeves 32 and 31.

Claims

1. Vasoregulation device for use during the phase prior to headache, in particular migraine, for applying pressure at least locally to one or more veins on the outside of the head, in order to restrict the flow of blood through the said veins, at least comprising pressure-exerting means.

2. Device according to claim 1, characterized in that the pressure-exerting means are designed to completely stop the flow of blood through the veins in question.

3. Device according to claim 1 or 2 , characterized in that the one or more veins comprise a temporal vein (1) .

4. Device according to claim 3, characterized in that the one or more veins comprise both temporal veins (1) .

5. Device according to claim 3 or 4 , characterized in that the pressure-exerting means are designed to apply pressure to the temporal vein (1) in question just above the ear, before it branches off into two smaller veins (2, 3) .

6. Device according to one or more of the preceding claims, characterized in that the pressure-exerting means comprise massage means for allowing the pressure-exerting means (8, 9) to carry out a massaging movement.

7. Device according to one or more of the preceding claims, characterized in that the pressure-exerting means comprise a bracket (5, 6; 14) with one or more pressure- exerting elements (8, 9).

8. Device according to claim 7, characterized in that the bracket (5, 6; 14) forms part of a pair of spectacles, a set of headphones or a component thereof .

9. Device according to claim 7 or 8 , characterized in that the pressure-exerting elements (8, 9) comprise a rounded pressure-exerting surface with dimensions which are slightly greater than the diameter of the vein to which pressure is being applied.

10. Device according to one or more of the preceding claims, characterized in that the pressure-exerting means comprise two hinged arms (23, 24), which are optionally directly coupled to one another, having pressure-exerting elements (8, 9), it being possible for the arms to interact with spring means in order to provide the necessary pressure .

11. Device according to claim 10, characterized in that the arms (23, 24) are hingedly coupled to a connecting support (27) and the spring means comprise one or more springs (30) .

12. Device according to claim 11, characterized in that the springs are so-called constant- force springs (30) .