CZ20023937A3 - Vaso-regulating device - Google Patents

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 where is said pressure-exerting means are designed to apply a pressure of 0,01 - 0,03 N/mm<2>. The device is thus intended for preventative use at the onset of migraine. <IMAGE>

Description

The invention relates to a vaso-regulating device for use during the pre-headache phase, in particular migraine, to apply pressure at least locally to one or more veins on the outside of the head to limit blood flow through these veins, the device at least comprising a pressure applying means.

Migraine is a periodically recurrent headache that usually means a highly localized headache. Approximately 10% of the population suffers from a more or less severe form of migraine.

There are many forms of migraine, but a migraine attack generally consists of two important distinct phases. It is the first phase before headache, which is often not accompanied by pain, but by specific symptoms before headache, such as visual disturbances, including the appearance of colored bubbles, lines and the like, or other disorders such as hearing or taste or smell. Often a light spot known as "aura." Also, numbness or burning of body parts such as fingers, hands, lips and the like is also made.

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

In most cases, this phase lasts 5 to 30 minutes before the headache and slowly disappears with the other symptoms before the headache.

Although these symptoms slowly disappear, they are replaced by their own real headache, which is often unbearable. This headache has a number of common side effects such as nausea, increased sensitivity to light, noise or odor, visual disturbances, diarrhea, yawning, sweating and the like. During this phase of headache, so-called vasodilatation occurs because the blood vessels in the head widen, resulting in lower blood pressure.

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2. Background Art

Numerous anti-migraine techniques and drugs are known in the art, but all work in the headache phase. For example, it is known to provide belts or the like between which platelets may be placed, with increasing tension around the head during headache, as disclosed in US-A-5,419,758, or the administration of drugs that counteract vasodilation.

Reference is also made in this regard to WO-A-9 907 323 of the Applicant, which discloses a vaso-regulating device using a clamp-shaped device with two arms as a pressure applying means.

SUMMARY OF THE INVENTION

The Applicant has surprisingly found that when the blood flow to the head decreases during the phase prior to the actual headache, there is very little or no headache during the subsequent headache phase. Indeed, no other means or medications have suppressed pain to a satisfactory degree. It is also undesirable to treat the patient's head during the headache phase, due to the hypersensitivity to all external stimuli during the headache.

The applicant has now found that the pressure exerted by the pressure applying means must be very specific.

To this end, it is an object of the present invention that said pressure applying means are designed to apply a pressure of 0.01 to 0.03 N / mm ² .

In a preferred embodiment, said compositions are utilized. pressure designed to apply a pressure in the range of 0.015 N to 0.025 N / mm ² and more preferably a pressure application of about 0.02 N / mm ² .

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By applying this specific, relatively high pressure, an optimum pain relief effect is obtained.

By using the device according to the invention with this specific pressure, it is possible to limit blood flow to certain veins on the outside of the head (the outside of the skull) during the pre-headache phase, thereby substantially preventing pain completely during the subsequent headache phase. An important advantage of the device according to the invention is that pain-free treatment is avoided.

In the present description, a vein means both a vessel and an artery.

The pressure applying means is preferably designed to stop blood flow through the respective vein.

The pressure applying means is preferably designed to apply pressure to at least one temporal vein, preferably both temporal veins.

In a most preferred embodiment, the pressure applying means is designed to exert pressure on the temporal vein just above the ear before it branches into two smaller veins.

The manner in which pressure is exerted on the respective vein or veins is not limited and can be performed in a wide variety of ways.

In a particular embodiment, the pressure applying means comprises massage means allowing the pressure applying means to perform massage movements.

In practice, it has been found that when the pressure applying means exerts massage movements, which may include any known massage movements such as vibration, rotation, rolling and the like, a very effective action of the device is achieved.

The device according to the invention may comprise a clamp with one or two pressure applying elements. The clamp of this type may of course be of any shape that is suitable for allowing the elements

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-4 the applied pressure exerted the desired pressure. Preferably, the clip element forms part of a pair of glasses, a headset, or a component thereof. Regardless of these shapes, face mask components, shoulder supports, etc. could also be considered.

The number of pressure applying elements is not limited and can vary from one to even ten pressure applying elements. However, the present invention preferably comprises two pressure acting elements which are suitable for applying pressure to both temporal veins. The shape of the surface of the pressure applying elements may vary as a function of the respective vein under which the pressure is applied. Preferably, the pressure applying elements comprise a circular surface having dimensions that are slightly larger than the diameter of the vein to which pressure is to be applied.

The material from which the pressure applying means is made is not particularly critical, but the portion of the pressure applying means coming in! in contact with the head in place of the respective vein, it is preferably made of a soft, slightly resilient plastic material.

In particular, it is advantageous that the pressure applying means section coming into contact with the head at the location of the respective vein, i.e. the pressure applying elements, is designed to be self-adjusting. For this purpose, the pressure applying elements can be fixed, for example, so that they can rotate in many directions.

In a special embodiment of the device according to the invention, the pressure applying means comprises two hinged arms, which are optionally directly connected to each other, and are provided with pressure applying elements, which allows the arms to interact with the spring means to provide the necessary pressure. This embodiment will be explained in more detail below with reference to the drawing. This relates to a headphone type device which can be fitted over the head, behind the head or under the chin.

The spring means preferably comprise so-called constant pressure springs. These are the springs that exert pressure under pressure • • • φ ♦ ·· • · · · · · · · · · · ·

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Approximately constant reaction force, in this case the force exerted by the means applying pressure to the respective veins. The reaction force (and hence the pressure) is defined by the spring force, the spring force arm, and the reaction arm arm, and can be maintained substantially the same for all practical spring displacements, ie for all practical sizes of a normal human head. spring due to pressure applying means.

In the device according to the invention, the constant pressure spring is preferably attached to one of the tilt arms at the first attachment point and to the other of the tilt arms at the second attachment point, the angle between the straight line connecting the pivot arm of the first tilt arm and the first attachment point and between the straight line connecting the pivoting pin of the second folding arm and the second securing point is greater than the angle between the line connecting the pivoting pin of the first folding arm and the means applying the pressure of the first folding arm and between the line connecting the pivoting pin of the second folding arm and the means applying the pressure of the second folding arm . This ensures that when the device is mounted on the human head, the pressure exerted on the head by the pressure applying means is substantially the same for all normal dimensions of the human head. In practice, a pressure difference of less than ± 1% can be achieved.

For example, assuming mirror symmetry, and that both hinged arms are attached to the same pivot pin, the spring attachment points are selected such that the line connecting each mounting point intersects the symmetry axis of the device at a greater angle than the line connecting the pressure applying means and the pivot pin . This has the effect that, for a varying angle between the hinged arms, and thus a changing displacement of the spring, the change of the spring sieve is compensated by the opposite change of the spring arm, so that its torque varies substantially in the same ratio as the reaction arm. Thus, the reaction force remains substantially constant.

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In a special embodiment, the constant force spring of the device comprises a spring with a low spring constant but relatively high preload. In this case, there will be only a relatively small change in spring force when the spring is displaced when adjusting the fitment device to a smaller or larger head.

The constant force spring according to the invention has preferably been biased to at least 20%, and in particular at least 50% of the maximum spring force than can be developed with the device when fitted to a normal human head size. This can be done by using a long helical spring that has been preloaded.

Preferably, each arm further comprises a proximal and distal arm portion which are pivotally connected to each other, wherein said pressure applying element is connected to said distal arm portion and the proximal arm portion is hingedly connected to the proximal portion of the other arm. This embodiment will also be explained in the description of the figure.

More preferably, said pressure applying element is attached to said distal arm portion at a point substantially opposite to the connection point between said distal arm portion and said proximal arm portion.

Preferably said device is substantially folded by rotating said distal arm portions to positions closely along said proximal arm portions. Thus, the device according to the invention can be stored, for example, in a case similar to the known spectacle case.

In a specific embodiment of the device according to the invention, these arms are further hingedly connected to said spring means. In this embodiment, both arms comprise hingedly connected distal and proximal portions forming said arms, said arms being hingedly connected to said spring means.

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Overview of the drawings

BRIEF DESCRIPTION OF THE DRAWINGS The invention will be explained in more detail with reference to the accompanying drawing, in which: Figure 1 is a schematic representation of a human head showing typical relative positions of the temporal vessels; Figure 2 is a front view of an apparatus according to one embodiment; Fig. 2 in a partially collapsed position; Fig. 4 shows the device of Fig. 2 in a fully collapsed position; Fig. 5 shows the device of Fig. 2 with the arms slightly spaced apart as ready for use by the user; Fig. 6 shows the device in a partially folded configuration suitable for deployment to the user; Fig. 7 shows the device of Fig. 2 in an exploded view; Fig. 8 shows a front view of one way in which the user can deploy the device Fig. 2, Fig. 9 is a front elevational view of a second way in which the device of Fig. 2 can be deployed; Fig. 10 is a perspective view a third way of deploying the device of FIG. 2 is shown, and FIG. 11 is a flow chart illustrating a method of using the device of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The invention will now be described more fully with reference to the accompanying drawing, in which preferred embodiments of the invention are shown. However, the present invention may be embodied in a number of different shapes, and it should be understood that it is limited to the embodiments shown herein. These illustrated embodiments are designed so that the subject matter of the disclosure will be thorough and complete, and will fully disclose the scope of the invention to those skilled in the art. The same reference numerals refer throughout the description to like elements and the first notation when used refers to like elements in alternative embodiments.

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Figure 1 schematically depicts a typical human head showing the relative positions of extracranial vessels passing through the head region of the head. The vessel 21 typically extends forward toward the ear and splits into two smaller vessels 22 and 23 above the ear where the smaller vessels extend forward and backward on the head, respectively, as shown. One skilled in the art will appreciate that this description primarily relates to the use of the invention via the temporal vessel 21. However, the invention may equally apply to vessels lying just below the skin, somewhere else in the body. Therefore, the term "vessel" when used herein may be applied to one or many vessels lying along the sleep regions or along other regions of the body.

The invention shown in Figures 2 to 10 includes a vaso-regulating device 20 for promoting compression of a blood vessel 21 lying just below the skin. The invention comprises spring means known in the art, preferably a spring 25, and in particular a biased helical spring for exerting a substantially constant force, an arm 27 coupled to a force transmission spring 25 and a pressure member 29 coupled to the arm for applying a force to the The device 20 may further preferably comprise a plurality of arms 27 attached to the spring 25, as shown in Figures 2 to 10, for transmitting force in more than one direction. In addition, the invention may also include a plurality of pressure elements 29 for applying force as a pressure to more than one point on the skin, as shown, for example, in Fig. 2.

The pressure may preferably be exerted by the device 20 by means of movements which thereby create a substantially massage action. Those skilled in the art will recognize that pressure can be exerted in a variety of ways, including, for example, vibration force, rotational force, pressure alternation and release, or a combination thereof. One of ordinary skill in the art will also readily appreciate that known means, such as small bikes, may be included in the device to create massage movements.

In addition, the spring means or spring 25 in this device preferably generates a substantially constant force and transmits this force to exert a substantially constant pressure to support the compression of the vessel 21. Those skilled in the art will recognize that the biasing member (spring means) that a substantially constant force, and in particular a constant force spring, can be produced by known manufacturing methods. For example, a constant force spring exerts a substantially constant force, regardless of displacement. Thus, the force exerted by the device 20, and consequently the pressure, remains constant, regardless of the size of the user's head. In addition, the application of a substantially constant force creates the advantage that no manual adjustment is required by the user, which could result in either insufficient pressure or excessive exerted pressure.

Referring now to FIG. 5, the torque (force multiplied by the force arm) of the spring force 28 about the hinge 39 must be counterbalanced by the same but opposite torque force exerted by the vein pressure applying elements 29. For the sake of symmetry, only the right side of the equipment is considered. As shown in Fig. 5, the torque of the spring force depends on the angle α between its arm II and the symmetry axis I of the device

20. The torque of this force which causes pressure in the pressure applying device depends on the angle β between its arm and the axis I of the symmetry of the device.

20 May

The angles α and β change as the tilting arms 33 rotate to adapt the device 20 to a smaller or larger head. Furthermore, the spring force depends on the length of the spring 25 and hence also on the angle α. This particular angular dependence can be compensated by making the angle α greater than the angle β. In the apparatus shown in Figure 5, α - β is about 40 °. In this case, when the tilting arms rotate, both angle α and angle β change in the same ratio. Spring force increases with increasing angle α, but its arm II decreases faster than arm III (roughly cos a, compared to cos β,

with an angle α greater than β). The net effect is that the force and hence the pressure exerted by the pressure applying elements 29 remains substantially the same for all normal human head sizes. In particular, the difference in pressure exerted in the normal size of the human head can be kept below 1%.

The pressure exerted by the device 20 is preferably in the range of about 0.01 N to about 0.03 N per mm ² . In a more preferred embodiment, the pressure is in the range of about 0.015 to about 0.025 N per mm ^2, and most preferably the pressure is about 0.02 N per mm ² . To exert such pressure, the applicator 29 preferably has a surface area of about 200 mm ² , although one skilled in the art will recognize that the surface area of the applicator may have a different dimension.

In a preferred embodiment of the invention, the pressure applying device comprises two arms 27 attached to the spring 25 for transmitting a substantially constant force, and a pressure element 29 coupled to each arm 27 to apply a force to the skin in the form of pressure to promote compression blood vessels

A device having two arms 27, each having a pressure applicator 29, preferably allows the user to position the device 20 and thus apply pressure to both sleep areas simultaneously, as shown in Figures 2 to 10.

2 to 10, each arm 27 further comprising a proximal arm portion 31 hingedly attached to the spring 25, an arm distal portion 33 pivotally attached to the arm proximal portion 31, and a pressurized device 20; an element 29 coupled to the distal portion 33 of the arm. The pivot mechanism connecting the proximal and distal portion of the arm also includes a pivot latch plate 34 of the distal portion 33 of the arm shown in Fig. 7, which acts to allow the distal portion of the arm portion 33 to rotate in defined increments or act as a latch. The proximal arm portion 31 also preferably includes a cover 32 of the proximal arm portion, as shown in Fig. 7.

7 attached to the arm distal portion 33, substantially at an opposite point to the junction point between the arm distal portion 33 and the arm proximal portion 31, as seen in Fig. 7. The arms 27 of the device 20 are preferably also hingedly connected to each other, as shown in FIGS. 2 to 10. This embodiment of the device may preferably be arranged to exert pressure with movement and thereby to create a substantially massage action.

In yet another preferred embodiment, the pressure applying device for assisting the compression of the extracranial vessels comprises spring elements, such as a spring 25, to exert a force, and two elongated curved arms 27 connected to the biasing means for transmitting the force. The connected curved arms define a substantially elliptical curve, with the spring elements preferably disposed along a major axis of the elliptical curve, as seen in Figs. 2 and 5. The pressure element 29 is attached to each curved arm to apply force to the skin, in the form of pressure; thereby promoting vascular compression. One of ordinary skill in the art will know that the extracranial vessel of the head lies outside the skull itself and lies just below the skin so that it is positioned between the skin and the skull.

This embodiment of the invention also preferably comprises folding curved arms 27 as shown in Figures 3, 4 and 6, each arm further comprising a proximal arm portion 31 hingedly attached to the spring means (biasing member) or the spring 25 and the distal portion 33 an arm pivotally connected to the arm proximal portion 31, and wherein the pressure member 29 is attached to the arm distal portion 33. A preferred hinged coupling mechanism is shown in Fig. 7 and comprises a spring 25 located in the sleeve 35 and two pins 37 connecting the spring 25 to the arms 27, preferably to the proximal arm portion 31 as shown. The spring 25 exerts a force to hold the arms 27 together, i.e. a force that acts as a pressure when the invention is properly fitted to the head by the user, as shown in Figures 8 to 10. As shown in Figures 4 to 10, the arms 27 • ·

they are hingedly connected to each other, preferably by means of a hinge 39 which comprises a resilient plastic material such as polypropylene. The pressure member 29, which is preferably connected to the arm distal portion 33 at a point substantially opposite the connection point between the arm distal portion 33 and the proximal arm portion 31, as seen in Fig. 2, also preferably includes a cover 41. The housing 41 may be somewhat resilient, to create a certain pressure distribution across the sleep area of the user. The housing 41 may also be easily displaceable, for sanitary purposes if the device 20 is shared by different users. The device 20 is thus foldable by rotating the distal leg portions 33 closely along the proximal leg portions 31 as shown in Figs. 3 and 4. This folding is further supported by the arms 27 being hingedly connected to each other as shown in Fig. 4. to allow more compact folding. As in other embodiments, the device 20 may preferably apply pressure by motion, thereby creating a massage action.

The invention further includes a portable system for compressing the extracranial vessels of the head lying under the skin on the head of the user. The system includes any collapsible embodiment of the pressure applying device 20, and a substantially portable pocket sized housing, wherein the user may conveniently carry the collapsed pressure applying device 20, which housing is approximately similar to the spectacle housing.

The method by which the device according to the invention can be used to compress extracranial vessels is illustrated in Fig. 11, which from the beginning comprises at block 51 a step of exerting a substantially constant force at block 53 in a mechanical device by a constant-force helical spring. The method further proceeds by applying a constant force in the block 55 to the temporal vessels, positioning the mechanical device close to these vessels, and thus to apply this force as a constant pressure. The preferred pressure in this method is a substantially constant pressure of about 0.02 N / mm ² .

In the same way, the development of migraine can be essentially stopped

The headache method, which is also shown in FIG. 11, comprises from the beginning in block 51 the use of a biasing member in a mechanical device to generate a substantially constant pressure of about 0.02 N / mm ² , followed by a substantially constant block force. 55 on the temporal vessels, during the pre-headache stage due to migraine in block 57, by positioning the mechanical device close to the temporal vessels, and thus to apply a force as a substantially constant pressure to these vessels. The pressure treatment is continued until the pre-headache phase is complete, and the process is then terminated in block 59.

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- 14PATENT CLAIMS

Claims (11)

PATENT CLAIMS 1. A vasocontrol 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, for limiting blood flow through these veins, the device at least comprising a pressure applying means, characterized in that wherein said pressure applying means is designed to apply a pressure of 0.01 to 0.03 N / mm ² . Device according to claim 1, characterized in that the pressure applying means are designed to apply a pressure of 0.015 N to 0.025 N / mm ² . The device of claim 2, wherein the pressure applying means is designed to apply a pressure of about 0.02 N / mm ² . Device according to claims 1 to 3, characterized in that the pressure applying means are designed to apply pressure to the temporal vein (21) just above the ear before it branches into two smaller veins (22, 23). Apparatus according to claims 1 to 4, characterized in that the pressure applying means comprises massage means which allow the massage movements to be carried out by the pressure applying means. Device according to claims 1 to 5, characterized in that the pressure applying means comprise two hinged arms (27) which are optionally directly connected to each other and are provided with pressure applying elements (29) to allow the arms (27) to interact with the spring arms. slings (25) for • ·· -15 to provide the necessary pressure. Device according to claim 6, characterized in that the spring means (25) comprise so-called constant pressure springs. The apparatus of claim 6 or 7, wherein each arm (27) further comprises a proximal arm portion (31) and a distal arm portion (33) that are pivotally connected to each other, wherein said pressure applying element (29) is connected to said distal arm portion (33) and the proximal arm portion (31) is hingedly connected to the second arm proximal portion (31). Device according to claim 8, characterized in that: characterized in that said pressure applying element (29) is connected to said arm distal portion (33) at a point substantially opposite to the connection point between said arm distal portion (33) and said arm proximal portion (31). Device according to claim 8 or 9, characterized in that said device is designed essentially as collapsible by rotating said distal arm portions (33) to positions closely along said proximal arm portions (31). Device according to claims 6 to 11, characterized in that the arms (27) are further hingedly connected to said spring means.