NL1008685C2 - Vasoregulation device. - Google Patents

Description

Short designation: Vasoregulation device.

The present invention relates to a vasoregulatory device for use during the pre-headache phase, especially migraine.

Migraine is a periodically recurring headache that usually concerns a very localized headache. About 10% of the population suffers from a more or less severe form of migraine.

There are many forms of migraine, but often a migraine attack consists of two important distinguishable phases. A first pre-headache phase, often without pain, but with specific pre-headache symptoms, such as, for example, visual disturbances, including the detection of colored balls, stripes and the like, or other disturbances, for example in the hearing or the sense of touch or smell. A spot of light called "aura" is often observed. Numbness or tingling of parts of the body, such as fingers, hands, lips and the like, also occurs.

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

The pre-headache phase usually lasts 5-30 minutes and slowly disappears along with the other pre-headache symptoms.

While these symptoms are slowly disappearing, they are replaced by actual headaches, which are often intolerable. This headache has a number of frequently occurring side effects, such as nausea, excessive sensitivity to light, sound or smell, visual disturbances, diarrhea, yawning, sweating and the like. During this headache phase, a so-called vasodilation occurs, namely a widening of blood vessels in the head, which results in a drop in blood pressure.

Many techniques and medicaments are known in the art for combating migraine, but all of these act on the headache phase. For example, it is known to apply tapes or the like with increased tension around the head with any disks interposed during the headache, such as disclosed in US-A-5,419,758, or the administration of anti-vasodilatory drugs.

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Neither of the methods or medicines mentioned provides really satisfactory pain relief. It is also undesirable to perform actions on the head of a patient during the headache phase due to the hypersensitivity to all external stimuli during the headache.

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

The present invention therefore provides a vasoregulatory device for use during the pre-headache phase, especially migraine, for applying pressure at least locally to one or more veins on the outside of the head to reduce blood flow through said reduce veins 15, at least comprising pressing means.

By using the device according to the invention, by reducing the blood flow of certain veins on the outside of the head (on the outside of the skull) during the pre-headache phase, the pain during the subsequent headache phase can be substantially completely avoided. An important advantage of the device according to the invention is that headaches are prevented without the use of a medicine.

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

Preferably, the pressing means are arranged to substantially completely eliminate the blood flow through the respective vein.

In particular, the pressing means are adapted to apply pressure to at least one sleeping vein, and preferably to both sleeping veins.

Most preferably, the pressing means are arranged to apply the pressure just above the ear to the temporal branch vein into two smaller veins.

The manner of applying pressure to the relevant vein (s) 35 is by no means limited and can be carried out in many different ways.

In a special embodiment, the pressing means comprise massage means for having a massaging movement of the pressing means.

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It has been found in practice that when the pressure means are applied, the pressing means perform a massage movement, which can comprise any known massage movement, such as vibrating, rotating, rolling and the like, a very good operation of the device 5 is obtained.

Research has shown that the average contact pressure required to reduce or eliminate the blood flow through the veins in question is approximately 5 N, with a small spread. It is preferred not to make this pressure controllable by the pressing means user-controllable, as there is a tendency for users to apply unnecessarily high pressure.

In a special embodiment of the device according to the invention, the pressing means comprise a bracket with one or more pressing elements. Such a bracket can of course have any shape which is suitable for allowing the pressing elements to apply the desired pressure. In particular, the bracket element forms part of glasses, headphones or a part thereof. Apart from these shapes, a part of a face mask, shoulder supports etc. could also be envisaged.

The number of pressing elements is not limited and can vary from one to 10 pressing elements. Preferably, however, the device comprises two pressure elements, which are suitable for applying pressure to the two sleeping veins.

Depending on the respective vein to which pressure is to be applied, the shape of the pressing surface of the pressing elements will vary. In particular, the pressing elements comprise a rounded pressing surface with dimensions slightly larger than the diameter of the vein to which pressure is applied.

The material from which the pressing means are made is not very critical, but advantageously the part of the pressing means that comes into contact with the head at the location of the vein concerned is made of soft, slightly resilient plastic material.

A particular advantage is that part of the pressing means which comes into contact with the head at the location of the vein concerned, or the pressing elements are designed in such a way that they are self-aligning. . For this purpose, the pressing elements can for instance be hinged in several directions.

In a special embodiment of the device according to the invention, the pressing means comprise two hinged legs, which may or may not be directly coupled together, with pressing elements, the legs being able to cooperate with spring means in order to provide the required pressing force. This embodiment will be explained in more detail below with reference to the drawing. This is a headphone-type device that can be worn over the head, behind the head, or under the chin.

Preferably the legs are hingedly coupled to a connecting strut and the spring means comprise one or more springs. These springs are particularly preferably so-called constant-15 force springs. These are springs that provide approximately constant resilience under load. This can be accomplished by using a relatively long coil spring with a large number of turns. The legs can be coupled together via a spring, but can also each be coupled to the connecting support via a spring.

The invention will now be further elucidated with reference to the annexed drawing. In it shows:

Fig. 1 is a schematic view of a human head showing the position of the sleep vein; 25 - FIG. 2 shows a first embodiment of the device according to the invention in headphone form;

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

Fig. 4 yet another embodiment of the device 30 according to the invention in a spectacle shape;

Fig. 5a-c three embodiments of the pressing elements;

Fig. 6a shows a partly cut-away embodiment of the device according to the invention with two legs and a connecting strut; 35 - Fig. 6b is a bottom view of the connecting strut of FIG. 6a; and

Fig. 6c is a side view of the connecting strut according to FIG. 6a.

In Figure 1, a human head is shown with a sleep vein 1 on the left side of the head. This vein is also called '10 086 85 5 the temporal vein. This vein runs along the front of the ear and splits above the ear into two smaller veins 2 and 3 running to the front and back of the head, respectively. The device according to the invention is preferably designed and is preferably applied in such a way that it reduces the blood flow of the sleeping vein 1 at the location of 4. According to the invention, this blood flow reduction (vasoregulation) takes place during the so-called pre-headache phase, which is also referred to as the vasoconstriction phase in classic migraine. During this vasoconstriction phase there is an increase in blood pressure and it has surprisingly been found that by an additional reduction in the blood flow through the sleep vein, the pain during the subsequent headache phase is considerably reduced and often does not occur at all. Fig. 2 shows a first embodiment of the device according to the invention schematically. This device comprises two bracket elements 5 and 6 which are hingedly connected to each other at 7. Both bracket elements 5 and 6 comprise pressing elements 8 and 9, which can be moved over the respective brackets 5 and 6 in order to ensure an accurate positioning of the pressing elements 8 and 9 and to be able to adjust the device depending on the dimensions of the head of the user, or the position of the respective veins, whose blood flow should be reduced. The pushing elements 8, 9 can for instance be positioned on the bracket elements 5, 6 by means of snap-on rails.

Reference numeral 10 denotes a set screw which is freely rotatably coupled to a portion 11 of the bracket member 6 and cooperates with the portion 12 of the bracket member 5, which has an internal screw thread, while the screw 10 has an external screw thread. With this adjusting screw 10, the pressing force of the bracket elements 5 and 6 on the head or the respective vein (s) can be adjusted. The material of the bracket elements 5 and 6 is not critical, but is preferably a somewhat resilient material such as, for example, plastic. The pressing elements 8 and 9 comprise rounded ends, which are preferably manufactured from a soft, somewhat resilient plastic.

Fig. 3 shows a modified embodiment of the device 40 according to the invention with a handle 13. The handle 13 is 1 n! . 86 8 5 6 an extension of the part 12 of bracket element 5. The presence of the handle 13 offers the advantage that the device is not placed over the head, as in the embodiment according to Fig. 2, but under the head. By grasping the handle 13, the user can move the device during use and thereby act massaging the veins with the pressing elements 8 and 9, which improves the operation of the device, and thus the result of the prevention of headaches.

The massage means can also be designed in other ways. This may include vibrating elements, whether or not directly driven by a motor or the like. Also, by suitable means, the pressing elements can rotate, move back and forth automatically, optionally with adjustable speed, etc.

Fig. 4 shows an embodiment of the device 15 in a so-called spectacle shape with a frame 14 with two legs 15 and 16. The pressing elements 8 and 9 are attached to the legs 15 and 16 and are preferably movable over the legs, so that these can be positioned appropriately. Optionally, in order to control the pressing force of the pressing elements 8, 20, the legs 15 and 16 could be connected to each other at the location of 17 and 18 (mounting behind the ears) by, for example, an adjustable strap or the like.

The pressing elements can be designed in many ways. Preferably, these pressing elements are movable where they come into contact with the vein to be influenced. The pressing elements 8 and 9, as indicated in the figure, can therefore, for example, take the form of a ballpoint shape, wherein a ball-shaped part can move freely in a cup. It is not necessary that two press-on parts are always used, it is also possible to use the device with only one part or several parts. All this will depend on the wishes of the user.

5a-c show different embodiments of the shape of the pressing elements, these pressing elements being designed as free-rotating wheels with a central axis.

In Fig. 5a, the pressure element comprises a ball-shaped wheel 19 with a central shaft 20.

In Fig. 5b, the pressing element comprises a flattened wheel 21 40 with a shaft 20.

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Fig. 5c shows an embodiment of the pressing element with a shaft 20 and two smaller spherical wheels 22. Many other embodiments of the pressing 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 legs 23 and 24 with pressing elements 8 and 9, which pressing elements comprise foam rubber caps which are hinged in different directions to fastening parts 25 and 26. These parts 10, 25 and 26 are in turn coupled to the legs 23 and 24, respectively.

The device according to Fig. 6a further comprises a sleeve-shaped connecting support 27 in which two hinge caps 28 and 29 are accommodated, which are mutually coupled by means of a constant force spring 30.

The hinge caps 28 and 29 each comprise a mounting sleeve 31, 32, respectively, in which the legs 23 and 24 are detachably attached.

The hinge caps 28 and 29 further comprise a stop collar 20, 33 and 34, respectively, which co-acts with the respective opening of the connecting support 27. Furthermore, in each hinge cap a coupling pin 35 is present, one of which is visible in the hinge cap 29, for coupling with the spring 30 .

Fig. 6d shows a bottom view and in Fig. 6c a side view 25 of the connecting support 27.

In Fig. 6a, a force is applied to the legs 23 and 24 in the direction indicated by the arrows, as a result of which the hinge caps 28 and 29 are tilted slightly under tension of the spring 30. This spring 30 preferably has the state of rest of the device already has a small bias.

It may be advantageous to place the attachment point 35 of the spring 30 on the hinge caps 28 and 29 on the other side of the respective legs. As a result, any occurring torque change and associated tension change during use can be minimized. All this falls within the reach of the average skilled person. It is preferred to design the spring and the coupling of the spring with the hinge caps in such a way that for different dimensions of human heads a substantially constant pressing force is obtained when using the device.

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

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Claims (12)

1. Vasoregulation device for use during the pre-headache phase, in particular migraine, for applying pressure at least locally to one or more veins on the outside of the head, in order to reduce blood flow through said veins, at least comprising pressing means. 2. Device as claimed in claim 1, characterized in that the pressing means are designed to substantially eliminate the blood flow through the veins concerned. Device according to claim 1 or 2, characterized in that the one or more veins comprise a sleep vein (1). Device according to claim 3, characterized in that the one or more veins comprise both temporal veins (1). Device according to claim 3 or 4, characterized in that the pressing means are arranged to apply pressure to the relevant sleeping vein (1) just above the ear for branching it into two smaller veins (2, 3). Device according to one or more of the preceding claims, characterized in that the pressing means comprise massage means for causing a massing movement of the pressing means (8, 9). Device according to one or more of the preceding claims, characterized in that the pressing means comprise a bracket (5, 6; 14) with one or more pressing elements (8, 9). 8. Device according to claim 7, characterized in that the bracket (5, 6; 14) forms part of glasses, headphones or a part thereof. Device according to claim 7 or 8, characterized in that the pressing elements (8, 9) have a rounded pressing surface <8 8 d 5 with dimensions slightly larger than the diameter of the vein on which pressure is applied. Device according to one or more of the preceding claims, characterized in that the pressing means comprise two hinged legs (23, 24), which may or may not be directly coupled to each other, with pressing elements (8, 9), the legs having spring means can cooperate to provide the necessary contact force. Device according to claim 10, characterized in that the legs (23, 24) are hingedly coupled to a connecting support (27) and the spring means comprise one or more springs (30). 15 Device according to claim 11, characterized in that the springs are so-called constant force springs (30). 1008685