RU2258497C2 - Vasculoregulating device - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: the present innovation is indicated to be applied during the phase being before the headache, migraine, in particular, due to applying the pressure, at least, locally onto one or more veins at external side of one's head to restrict circulation in veins. The device contains means for supplying the pressure designed with possibility to supply the pressure within the range of 0.01-0.03 N/sq. mm. The innovation provides accurate limits of impact to decrease circulation during the phase being before the headache.

EFFECT: higher efficiency.

10 cl, 11 dwg

Description

The invention relates to a vasoconstrictor device for use during the phase preceding a headache, in particular migraine, by applying pressure to at least one or more veins on the outside of the head to restrict blood flow to said veins containing at least means of applying pressure.

Migraine is a recurring headache, usually a very localized headache. About 10% of the population suffers from migraine in a more or less serious form.

There are many forms of migraine, but usually a migraine attack consists of two main distinct phases. The first phase precedes a headache, and is often not accompanied by severe pain, but has certain preceding headache symptoms, such as visual impairment, including the sight of colored bubbles, lines, etc., or other disorders, such as hearing impairment, or sensation taste or smell. Often seen a light spot, known as "auras". Numbness or tingling also appears in some parts of the body, such as fingers, hands, lips, etc.

In the case of a classic migraine attack, this preceding headache phase is accompanied by the so-called vasoconstriction (narrowing of blood vessels), which is a narrowing of the head veins, causing a local increase in blood pressure.

In most cases, the preceding headache phase lasts from 5 to 30 minutes and slowly disappears along with other symptoms preceding the headache.

As these symptoms slowly disappear, the headache itself occurs instead of them, sometimes intolerable. This headache has a number of frequently occurring side effects, such as nausea, hypersensitivity to light, noise or smell, visual impairment, diarrhea, yawning, sweating, etc. During this phase of headache, the so-called vasodilation (expansion of blood vessels), namely the expansion of blood vessels in the head, which leads to a decrease in blood pressure.

Many methods and drugs are known in the art for countering migraines, but all of them act during the headache phase. For example, it is known that belts or the like are arranged around the head, possibly with disks mounted between them, the tension of which increases during a headache, according to US-A-5419758; or medication is known to counteract the expansion of blood vessels.

In this regard, reference is made to document WO-A-9907323 in the name of the applicant of this vessel control device using a device in the form of a bracket with two arches acting as pressure application means.

The applicant found that if blood flow to the head was reduced during the phase preceding the actual headache, then during the subsequent phase of the headache it is very mild or does not occur at all. All other methods or medicines do not actually suppress pain to a satisfactory degree. It is also undesirable to treat the patient’s head during the headache phase due to hypersensitivity to all external stimuli during the headache.

The applicant has found that the pressure applied by the means of applying pressure must be very accurately determined.

To this end, the present invention is characterized in that said pressure application means is configured to apply pressure of 0.01-0.03 N / mm ² .

The pressure application means is preferably configured to apply a pressure of 0.015-0.025 N / mm ² , and more preferably about 0.02 N / mm ² .

By applying this determined relatively strong pressure, an optimal analgesic effect is achieved.

By using the device according to the invention with a certain pressure, it is possible to restrict blood flow in certain veins on the outside of the head (on the outside of the skull) during the preceding headache phase to substantially eliminate the occurrence of pain during the subsequent headache phase. An important advantage of the device according to this invention is that the occurrence of headache is prevented without the use of a drug.

As used herein, the term “vein” means both a blood vessel and an artery.

Means for applying pressure are preferably configured to completely stop blood flow through a vein.

In particular, the means for applying pressure are configured to apply pressure to at least one temporal vein, preferably both temporal veins.

More preferably, the pressure application means is configured to apply pressure to the temporal vein directly above the ear, before it branches into two smaller veins.

The possibilities of applying pressure to the vein (s) are in no way limited and can be varied.

According to a particular embodiment of the invention, the means for applying pressure comprise a massaging means that enables massaging movement by means of applying pressure.

In practice, it has been found that if, upon application of pressure, the means for applying pressure carry out a massage movement, which may include any known massage movement, such as vibration, circular motion, etc., then a very effective action of the device is ensured.

The device according to this invention may contain a bracket with one or more pressure application elements. Of course, the bracket of this type can be of any shape suitable for the pressure application elements to apply the desired pressure. In particular, the staple element forms part of a pair of glasses, headphones, or a part thereof. In addition to these forms, you can also consider the detail of the mask, shoulder pads, etc.

The number of pressure application elements is not limited, and 1 to 10 pressure application elements may be provided. But it is preferable that the device contains two pressure application elements configured to apply pressure to both temporal veins.

The shape of the pressure applying surface of the pressure application elements may vary depending on the particular vein to which pressure is applied. In particular, the pressure application members comprise a rounded pressure-applying surface, the dimensions of which slightly exceed the diameter of the vein to which pressure is applied.

The material from which the means of applying pressure is made is not of particular importance for the present invention, but it is advisable that the part of the means of applying pressure that contacts the head at the location of the vein should be made of soft, somewhat elastic plastic.

It is particularly advisable that the part of the means of applying pressure that contacts the head at the location of the vein, i.e. pressure application elements were made with the possibility of self-centering. For this, pressure application elements can, for example, be mounted rotatably in several directions.

According to a particular embodiment of the device of the present invention, the pressure application means comprise two hinged arms, which, as an option, are directly connected to each other, have pressure application elements and are adapted to interact with the spring means to provide the necessary pressure. This embodiment is explained in the following more detailed description with reference to the drawings. This embodiment provides a headphone device that can be worn on the head, behind the head or under the chin.

The spring tool preferably contains the so-called constant force spring. These are springs that, under load, create an approximately constant counteracting force; in this case, the force exerted by means of applying pressure on the corresponding veins. The counteracting force (and therefore the pressure) is determined by the spring force, the buckle of the spring force and the bow of the opposing force, and it can be maintained substantially the same for all practical spring displacements, i.e. for all practical head sizes. This can be achieved by selecting the attachment points for the spring relative to the means of applying pressure.

In the device according to the invention, the constant-force spring is preferably attached to one of the hinge arms at the first attachment point and to the other hinge arm at the second attachment point; wherein the angle between the line connecting the center of rotation of the first articulated arch and the first attachment point, and the line connecting the center of rotation of the second articulated arch and the second attachment point, exceeds the angle between the line connecting the center of rotation of the first articulated arch and the means of applying pressure of the first articulated arch, and a line connecting the center of rotation of the second articulated arch and means for applying pressure of the second articulated arch. Due to this, they ensure compliance of the device with the head; and the pressure applied to the head by means of applying pressure is essentially equal for all heads of normal sizes. In practice, a pressure difference of less than ± 1% can be achieved.

For example, on the basis of mirror symmetry and the fastening of both hinged arches in the same center of rotation, the spring attachment points are chosen so that the line connecting each attachment point and the rotation center crosses the symmetry line of the device at a greater angle than the line connecting the means pressure applications and center of rotation. As a result of this, in order to change the angle between the hinge arms and therefore change the spring displacement, the change in the spring force is compensated by the opposite change in the spring force arm, as a result of which its torque changes essentially to the same extent as the arm of the opposing force. This opposing force remains essentially constant.

According to a particular embodiment, the constant-force spring of the device comprises a spring with a low spring constant, but with a relatively high prestress. In this case, only a relatively small change in the spring force will occur when the spring is displaced, when the device is adjusted for a smaller or larger head.

The constant-force spring of the device is preferably prestressed by at least 20% and more preferably at least 50% of the maximum spring force that can be applied when the device is mounted on a normal-sized head. This can be done using a prestressed coil spring.

It is advisable that each arc has a near part of the arc and the distal part of the arc, rotatably connected to each other, while this pressure application element is connected to the specified distal part of the arc, and the near part of the arc is pivotally connected to the proximal part of the other arc. This embodiment is illustrated in the accompanying drawings.

More suitably, the pressure application member is connected to the distal portion of the arch at a point substantially opposite the connection point between the distal portion of the arch and the proximal portion of the arch.

In particular, said device is substantially collapsible by rotation of the distal parts of the arch to a position along the proximal parts of the arch. Thus, the device according to this invention can be stored, for example, in a case similar to the well-known case for glasses.

According to a particular embodiment of the invention, the arms are also pivotally connected to spring means. In this embodiment, both arches comprise the distal and proximal rotatably connected parts that form the arches, said arches being pivotally connected to the spring means.

The invention is further explained in more detail with reference to the accompanying drawings, in which:

Figure 1 is a schematic illustration of a human head indicating a typical relative position of the temporal blood vessels;

Figure 2 is a front view of a device according to an embodiment of the present invention;

Figure 3 - the device depicted in figure 2, in a partially folded position;

Figure 4 - the device depicted in figure 2, in the fully folded position;

Figure 5 - the device depicted in Figure 2, with slightly retracted arches, in preparation for use by the user;

6 is a partially folded configuration of the device, ready to be worn;

Fig.7 is an image with a spatial separation of the parts of the device depicted in Fig.2;

Fig. 8 is a front view illustrating one view in which a user can put on the device of Fig. 2;

Fig.9 is a front view showing a second view in which the user can put on the device shown in Fig.2;

Figure 10 is a perspective view of a third view in which the user can put on the device depicted in Figure 2;

11 is a diagram of a method of using the device according to this invention.

The invention will now be described in more detail with reference to the accompanying drawings, in which preferred embodiments of the invention are shown, but this invention may be embodied in various forms and should not be construed as being limited by the illustrated embodiments set forth below. The illustrated embodiments are presented for completeness of disclosure, and fully reflect the scope of the invention for specialists in this field of technology. Like numbers refer to the same elements throughout the specification, and the first reference indicates the same elements in alternative embodiments.

Figure 1 schematically depicts a head with a mutual arrangement of intracranial blood vessels passing through the temporal region of the head. The blood vessel 21 usually passes in front of the ear, is divided into two smaller blood vessels 22 and 23, respectively, diverging forward and backward along the head, according to the image. One skilled in the art will understand that this description primarily relates to the application of the invention, generally, to the temporal blood vessel 21. But the invention may equally be applicable to blood vessels adjacent to the surface of the skin on any part of the body. Therefore, the term “blood vessel” as used herein can be applied to one or more blood vessels in the temporal region or in other parts of the body.

2-10, the invention includes a vasodilator 20 designed to facilitate compression of a blood vessel 21 located close to the skin. The device comprises a spring means known from the prior art, preferably a spring 25, and in particular a prestressed coil spring, for generating a substantially constant force, an arm 27 connected to the spring 25 for transmitting force, a pressure member 29 connected to the arm, for applying force - in the form of pressure - to the skin in order to compress the blood vessel 21. The device 20 may also preferably comprise several arches 27 connected to a spring 25, according to FIGS. 2-10, for transmitting force in more than one direction lion. Moreover, the device 20 may also contain several pressure elements 29 for applying force in the form of pressure to more than one point on the skin, for example, as shown in FIG.

It is advisable that the pressure can be applied by the device 20 simultaneously with the movement, in order to provide a substantially massaging effect. Those skilled in the art will appreciate that pressure can be applied in a variety of ways, including, for example, in the form of a vibrating force, rotational force, alternating application of pressure, or a combination thereof. One skilled in the art will also appreciate that known means such as microelectric motors can be provided in a device for performing this massaging movement.

In addition, in the device 20, the spring means or spring 25 preferably generates a substantially constant force and transmits a force to apply a substantially constant pressure to compress the blood vessel 21. It will be understood by those skilled in the art that the biasing element (spring means) producing a substantially constant force, in particular a constant-force spring, can be performed by known technological methods. For example, a constant-force spring exerts a substantially constant force regardless of displacement. Thus, the force exerted by the device 20, and therefore the pressure, remains constant regardless of the size of the user's head. Moreover, the application of essentially constant force provides the advantage of eliminating the need for manual adjustment by the user, which can lead either to insufficient pressure or to the application of excessive pressure.

Turning to FIG. 5, the torque (the force multiplied by the arm of the force) of the spring force of the spring 28 around the hinge 39 must be balanced by the equal but opposite torque of the force exerted by the pressure application elements 29 on the vein. For symmetry purposes, only the right side of the device is considered. According to FIG. 5, the torque of the spring force depends on the angle α between its arm II and the line of symmetry I of the device 20. The torque of the force causing pressure in the pressure application means depends on the angle β between its arm III and the line of symmetry I of the device.

The angles α and β change when the hinge arms 33 are rotated to adjust the head device 20, smaller or larger. In this case, the spring force depends on the length of the spring 25 and therefore also on α. This additional angular dependence can be compensated by making the angle α larger than β. In the device depicted in Figure 5, α-β is about 40 ^about . In this case, when the articulated arms are rotated, both α and β change to the same extent. The spring force increases with increasing α, but its arm II decreases faster than arm III (approximately cosα compared to cosβ, with α greater than β). The end result of this circumstance is that the force and therefore the pressure exerted by the pressure applying members 29 remains substantially the same for all the usual head sizes. In particular, the difference in applied pressure, which is normal for a normal-sized head, can be maintained within less than 1%.

The pressure applied by the device 20 is preferably in the range of 0.01 to 0.03 N / mm ² . More preferably, the pressure has an approximate range of 0.015 to 0.025 N / mm ² , and most preferably about 0.02 N / mm ² . To apply this pressure, the applicator 29 preferably has a surface area of about 200 mm ² , although it is known to those skilled in the art that the surface area of the applicator may have other values.

According to a preferred embodiment of the present invention, the pressure application device comprises two temples 27 connected to a spring 25 to transmit a substantially constant force, and a pressure member 29 connected to each arch 27 to apply pressure as pressure to the skin to compress blood vessel 21. A device having two temples 27, each of which has a pressure applicator 29, allows the user to install the device 20 so as to apply pressure to both temporal regions simultaneously but according to FIGS. 2-10.

The pressure application device 20 has a folding embodiment, as shown in FIGS. 2-10, in which each temple 27 comprises a near arc portion 31, articulated to a spring 25, a distant arc portion 33, rotatably connected to the near arc portion 31, and a pressure member 29 connected to the back of the bow. The rotation mechanism connecting the near and far parts of the bow also includes a plate 34 of the latch of the axis of rotation of the far bow, as shown in Fig.7, which allows the far part 33 of the bow to rotate around the axis with certain increments, or clicks. The proximal portion 31 of the bow also preferably comprises a cap 32 of the proximal portion of the bow, as shown in FIG. In this embodiment, the pressure member 29 is preferably connected to the back of the bow 33 at a point substantially opposite the connection point between the back of the bow and the proximal bow 31, as shown in FIG. 7. The arms 27 of the device 20 are preferably pivotally connected to each other, as shown in FIGS. 2-10. The device according to this embodiment can also preferably be placed with the possibility of applying pressure in conjunction with the implementation of the movement, thereby thereby providing a substantially massaging effect.

According to another preferred embodiment, the pressure application device 20 for compressing an extracranial blood vessel comprises spring means, for example a spring 25, for generating force, and two elongated curved arms 27 connected to the deflecting element for transmitting force. The connected curved arches define an essentially elliptical curve having spring means, preferably located along the main axis of the elliptical curve, as shown in FIGS. 2 and 5. A pressure member 29 is connected to each curved arch to exert pressure - in the form of pressure - on the skin for compression blood vessel. A person skilled in the art will understand that the intracranial blood vessel of the head is located outside the skull itself and is located close to the skin, i.e. between the skin and the skull.

This embodiment also preferably comprises foldable curved arms 27, as shown in FIGS. 3, 4 and 6; wherein each handle also contains the middle part 31 of the arc, pivotally connected to the spring means (biasing element), or spring 25, the distal part 33 of the arc connected to the near part of the arc rotatably, and the pressure element 29 is connected to the far part of the arc . A preferred articulated joint mechanism is depicted in FIG. 7 and comprises a spring 25 mounted in the sleeve 35 and two studs 37 connecting the spring to the arms 27, preferably to the proximal portions 31 of the temple. The spring 25 creates a force bringing together the arms 27, a force that is applied as a pressure when the device is correctly worn on the user's head, as shown in Figs. 8-10. As shown in Figs. 4-10, the arms 27 are also pivotally connected to each other with another, preferably using a hinge 39 containing an elastic plastic material such as polypropylene. The pressure element 29, which is preferably connected to the rear part of the temple at a point substantially opposite the connection point between the far part of the temple and the near part 31 of the temple, as shown in FIG. 2, also preferably comprises a cover 41. The cover 41 may have a slightly elastic design to provide some pressure distribution over the temporal region of the user. Case 41 can also be easily replaced for sanitary purposes if the device 20 is used by different users. The device is designed as folding due to rotation around the axis of the distant parts 33 of the temple in a position along the proximal parts 31 of the temple, as shown in FIGS. 3 and 4. This folding is also facilitated by the arms 27, pivotally connected to each other, as shown in Figure 4, to provide more compact folding. As in other embodiments, the device 20 can preferably apply pressure in conjunction with movement to thereby provide a massaging effect.

The invention also includes a portable system for compressing an extracranial blood vessel under the scalp. This system includes any of the folding embodiments of the pressure application device 20 and an essentially pocket case in which the user can conveniently carry the folded pressure application device with him, this case resembling a case for glasses.

The method according to which the device according to this invention can be used to compress an extracranial blood vessel is depicted in FIG. 11, in which, starting from the start in block 51, includes the step of creating a substantially constant force (block 53) in the mechanical device using coil spring constant force. This is followed by the step of applying a constant force (block 55) to the temporal blood vessel by placing a mechanical device near it in order to apply force with essentially constant pressure. According to this method, the preferred pressure is a substantially constant pressure of approximately 0.02 N / mm ² .

In the same way, the increase in headache during migraine can essentially be stopped, which is also illustrated in Fig. 11. The method, starting from the start-up (block 51), involves the use of a biasing element in a mechanical device to create a substantially constant force of about 0.02 N / mm ² , after which the step of applying a substantially constant force (block 55) to the temporal blood to the vessel during the migraine stage preceding the headache (block 57) by placing a mechanical device near the temporal blood vessel to apply substantially constant pressure to it. They continue to apply pressure until the phase preceding the headache ceases; the method ends at block 59.

Claims (11)

1. A method of limiting blood flow during the phase preceding the headache, comprising the steps of: providing a vasodilating device for use during the phase preceding the headache, in particular migraine, to apply pressure at least locally to one or more veins on the outer side of the head to limit blood flow through these veins, at least containing a means of applying pressure, characterized in that the means of applying pressure exerts a pressure in the range of 0.01-0.03 N / mm ² . 2. The method according to claim 1, characterized in that the means of applying pressure exerts a pressure in the range of 0.015-0.025 N / mm ² . 3. The method according to claim 2, characterized in that the means of applying pressure exerts a pressure of about 0.02 N / mm ² . 4. The method according to claim 1, characterized in that the pressure is applied by means of applying pressure to the temporal vein (21) immediately above the ear before it branches into two smaller veins (22, 23). 5. The method according to claim 1, characterized in that the massaging movement is carried out by means of a pressure application containing means for massaging. 6. The method according to claim 1, characterized in that they use a means of applying pressure, containing two hinged arches (27), which are not necessarily directly connected to each other, and having elements (29) of applying pressure, while the arches (27) interact with spring means (25) to provide the necessary pressure. 7. The method according to claim 6, characterized in that they use spring means (25) containing a constant-force spring. 8. The method according to claim 6 or 7, characterized in that each temple (27) also contains the near part (31) of the temple and the far part (33) of the temple, which are connected to each other with the possibility of rotation, while the element (29) applications of pressure are connected to the rear part (33) of the temple, and the near part (31) of the temple are pivotally connected to the near part (31) of the temple of another temple (27). 9. The method according to claim 8, characterized in that the pressure applying element (29) is connected to the rear part (31) of the temple at a point substantially opposite the connection point between the far part (33) of the temple and the near part (31) of the temple. 10. The method according to claim 8 or 9, characterized in that the device is performed essentially folding by turning around the axis of the distant parts (33) of the temple in a position along the proximal parts (31) of the temple. 11. The method according to claim 6, characterized in that the arms (27) are pivotally connected to the spring means.

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