EP3946181A1 - Appareil externe pour la tête, permettant de faire baisser le tonus des muscles de la mâchoire chez des patients atteints de bruxisme et/ou d'autres dysfonctionnements crânio-mandibulaires (dcm) - Google Patents

Appareil externe pour la tête, permettant de faire baisser le tonus des muscles de la mâchoire chez des patients atteints de bruxisme et/ou d'autres dysfonctionnements crânio-mandibulaires (dcm)

Info

Publication number
EP3946181A1
EP3946181A1 EP20714514.5A EP20714514A EP3946181A1 EP 3946181 A1 EP3946181 A1 EP 3946181A1 EP 20714514 A EP20714514 A EP 20714514A EP 3946181 A1 EP3946181 A1 EP 3946181A1
Authority
EP
European Patent Office
Prior art keywords
spring
head apparatus
hard wires
external head
bent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20714514.5A
Other languages
German (de)
English (en)
Inventor
Christoph SEIDENSTÜCKER
Amir Moazzen SAFAEI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Relaxbogen GmbH
Original Assignee
Relaxbogen GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE202019001429.2U external-priority patent/DE202019001429U1/de
Priority claimed from DE102019002200.9A external-priority patent/DE102019002200A1/de
Application filed by Relaxbogen GmbH filed Critical Relaxbogen GmbH
Publication of EP3946181A1 publication Critical patent/EP3946181A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H1/00—Apparatus for passive exercising; Vibrating apparatus; Chiropractic devices, e.g. body impacting devices, external devices for briefly extending or aligning unbroken bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H13/00—Gum massage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H39/00—Devices for locating or stimulating specific reflex points of the body for physical therapy, e.g. acupuncture
    • A61H39/04—Devices for pressing such points, e.g. Shiatsu or Acupressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A61F2005/563—Anti-bruxisme
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/02—Characteristics of apparatus not provided for in the preceding codes heated or cooled
    • A61H2201/0207—Characteristics of apparatus not provided for in the preceding codes heated or cooled heated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/1604—Head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/1604—Head
    • A61H2201/1607—Holding means therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/1645—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support contoured to fit the user
    • A61H2201/1647—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support contoured to fit the user the anatomy of a particular individual
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors

Definitions

  • the present invention relates to an improved external head apparatus for lowering the tone of the masticatory muscles in patients with bruxism and / or other craniomandibular dysfunctions (CMD) and a kit for producing corresponding external head apparatus.
  • CMD craniomandibular dysfunctions
  • CMD patients especially those who suffer from bruxism (grinding and / or clenching of teeth), often show pain in the area of the masticatory muscles and the temporomandibular joints.
  • CMD patients regularly have muscular imbalances in the jaw area due to increased muscle activity. This muscular hyperactivity exacerbates the symptoms of the patient, it increases the bruxism and thereby promotes greater abrasion of the teeth. Furthermore, the imbalances in the muscle chains can continue in the entire holding and movement apparatus and lead to secondary symptoms.
  • the standard therapy is usually first to make a bite splint. In addition to protecting the teeth, this also eliminates any movement patterns that may have arisen (slideways of the teeth during grinding movements). Since the conventional occlusal splint, which is used in the mouth, can usually only be worn at night, there is practically no effect on muscle tone during the day. In addition, due to the poor comfort of such a splint, there is often only a moderate level of acceptance among patients. There is therefore a continuing need to develop other approaches to the treatment of CMD patients that can supplement, support or replace the established therapy with the occlusal splint.
  • EP 0654981 B1; US 5586562 A; US 5553626 A; US 5490520 A; US 4989616 A; US 4976618 A; US5190051; US 5078153 A or US 4995404 A) are based, for example, on the principle that an electronic or electromechanical detector is inserted into the mouth between the upper and lower row of teeth, which is connected to another device which, in the event of grinding, generates an acoustic or other type of detector Sends out alarm signal.
  • corresponding external head devices have undergone constant further development, in particular to increase the effectiveness, comfort and durability, and to reduce production costs.
  • the state of the art in the area of the corresponding head appliances is best represented by the latest model of the corresponding head appliances that is currently available on the market.
  • a corresponding external head apparatus is disclosed, for example, in J. Lambers; Journal of Craniomandibular Function 2018; 10 (2): 147-159 and in J. Lambers et al .; Orthodontics News; Special print edition 6/15, June, 13th year and in J. Lambers et al .; Manual medicine; DOI 10.1007 / s00337-016-0169-9.
  • This prior art is also shown in FIG.
  • Such a head apparatus includes two bent, spring-hard wires with contact surfaces at the ends that are only connected by a single connecting element.
  • connection element in the configuration according to the prior art is subject to relatively high mechanical loads when putting on and taking off the head apparatus, which means that relatively high-quality and cost-intensive materials have to be used as connection element to ensure durability.
  • the present invention is thus based on the object of eliminating or at least alleviating the above-described after parts of known external head devices and to achieve the improvements sought.
  • Fig. 1 An external head apparatus according to the prior art.
  • the present invention relates in particular to an external head apparatus for lowering the tone of the masticatory muscles in patients with bruxism and / or other craniomandibular dysfunction (CMD), comprising
  • Hard wires are known to those skilled in the art.
  • a bent spring-hard wire is when the spring-hard wire is not straight, but rather has a curve.
  • a curved one Spring-hard wire within the meaning of the present invention can be curved, for example, into an open circle or an arc.
  • designs with two bent, spring-hard wires are usually particularly advantageous because of their high wearing comfort, specific head devices can also be used, which advantageously address additional muscle areas through the use of three or more bent, spring-hard wires or achieve increased stabilization through the additional wires .
  • the external head apparatus according to the invention comprises not less than two bent spring-hard wires, but an apparatus with a total of four bent spring-hard wires can also be according to the invention.
  • a separate connecting element in the sense of the present invention is any element by which two spring-hard wires can be firmly connected to one another, in particular such that a completely free movement of the two spring-hard wires relative to one another is hindered.
  • Corresponding separate connecting elements are known to the person skilled in the art, consist of commercially available materials and can be worked with established tools.
  • the separate connecting elements can be plastic elements, in which recesses are drilled with conventional tools for receiving the spring-hard wires, in which the spring-hard wires can be fixed.
  • these are separate, i.e. connecting elements that differ from each other and from the spring-hard wires must act.
  • a twisting, gluing or welding of the spring-hard wires would, for example, just as little a connection by separate connecting elements as a single connecting element which touches the spring-hard wires only at two separated areas.
  • the connecting elements are in contact with the spring-hard wires via connecting areas, the length dimensions of which can vary.
  • the distance between two separate connecting elements in relation to a spring-hard wire is the distance between the connecting area, i.e. Understood the contact area between the first separate connecting element and the spring-fixed wire and the connecting area between the second separate connecting element and the spring-fixed wire.
  • the bent, spring-hard wires each have a support at both ends.
  • a support can, for example, be a mere thickening of the spring-hard wire or a separately arranged component, for example made of plastic, and serves to distribute the support intensity on the muscle. Preference is given to both ends the bent spring-hard wires arranged a separate support, the support being preferably made of plastic.
  • the bent, spring-hard wires are connected to one another by the two separate connecting elements in such a way that the external head apparatus can be fixed to a human head.
  • Corresponding fixation is achieved according to the invention by the relative arrangement of the two bent spring-hard wires to each other by the two separate connecting elements, so that the bent spring-hard wires and / or the supports arranged at the ends exert a slight pressure on the flanks of the head on both sides.
  • a further fixation of the head apparatus can also be supported by resting one of the spring-hard wires on the ears.
  • the supports lie in the facial area of the human being, whereas the spring-hard wires usually run in an arc behind the head.
  • the spring-hard wires connected to one another are shaped in such a way that, when the external head apparatus is fixed to a human head, pressure is exerted on trigger points and / or fascia of the two large masticatory muscles, the masseter and temporalis muscles, on the right-hand side and the left side of the human head is exercised, on which the basic therapeutic benefits of corresponding external head devices are based and which is described in more detail in the prior art (see, for example, DE102010033224 B4).
  • An external head apparatus has a plane of symmetry which intersects the two bent, spring-hard wires. By mirroring one side of the head apparatus at this level, it can be mapped onto the other side of the apparatus.
  • the corresponding plane of symmetry is shown in FIG.
  • the plane of symmetry preferably runs through the head apparatus in such a way that the spring-hard wires and the supports arranged at their ends are each half on one side and half on the other side of the plane of symmetry. If the head apparatus is on a human Chen head is fixed, ie in the worn state, the plane of symmetry of the external head apparatus preferably essentially coincides with the plane of symmetry of the head.
  • the plane of symmetry is particularly preferably perpendicular to the plane of symmetry.
  • the present invention also assumes the presence of a plane of symmetry if the ideal symmetry is slightly disturbed, i.e. a plane of symmetry is assumed according to the invention if the degree of coverage achieved by reflection on the plane of symmetry is greater than 95%, preferably greater than 98%, particularly preferably greater than 99%.
  • a plane of symmetry is assumed according to the invention if the degree of coverage achieved by reflection on the plane of symmetry is greater than 95%, preferably greater than 98%, particularly preferably greater than 99%.
  • Corresponding deviations from the ideal symmetry can be determined by a person skilled in the art using simple measurement techniques or the use of image processing software and can arise in practice, for example, from minor manufacturing errors or from individual adjustments to human heads that are not completely symmetrical.
  • the head apparatus it has also proven to be particularly favorable that by positioning two connecting elements that are moved away from the spine and closer to the ears relative to the prior art, it is particularly easy to select suitable connecting elements (especially with regard to the size) to increase the wearing comfort even for those patients whose anatomy in the ear area has led to adaptation problems in designs according to the prior art.
  • a flat slope can be better realized in the area of the ears without the effect of the external head appliance on the masticatory muscles being reduced.
  • An external head apparatus is preferred (preferably as referred to above as preferred), wherein the bent, spring-hard wires are made of stainless steel, and / or wherein the connecting elements are made of a material selected from the group consisting of engineering and high-performance plastics, is preferably selected from the group consisting of PEEK, PA, POM, PC and PEK, and / or wherein the conditions consist of a material which is selected from the group consisting of construction and high-performance plastics, preferably selected from the group consisting of PEEK, PA, POM, PC and PEK.
  • Correspondingly preferred external head apparatus are particularly advantageous because the materials listed for the production of the external head apparatus have particularly favorable processing properties, do not adversely affect the total weight of the external head apparatus and because in practice the corresponding materials are suitable for the specific load profile which an external head apparatus according to the invention experiences, have proven to be particularly resistant and durable.
  • an external head apparatus (preferably as referred to above as preferred), wherein when the external head apparatus is fixed to a human head, viewed from the frontal perspective, at least one of the bent spring-hard wires above the both on the right and on the left head side human ear and at least one of the bent, spring-hard wires is arranged under the human ear, and / or the plane of symmetry of the external head apparatus is essentially identical to the plane of symmetry running centrally through the human head,
  • the expression frontal perspective means that the human head is viewed from the front in the natural position, i.e. the eyes are facing forward at the viewer and the eyes are over the mouth.
  • the expression “essentially identical” means that, apart from small deviations, the planes of symmetry coincide (assuming an ideally symmetrical head). In other words, this means that the symmetry of the human head is not broken by the application of the external head apparatus.
  • the expression “when the external head apparatus is fixed to a human head means the intended self-supporting fixation as described above.
  • Correspondingly preferred external head apparatuses are particularly advantageous because, despite a large number of conceivable alternative design options for designing an ex ternal head apparatus, the preferred embodiments have proven in practice to be the external head apparatus, in which the highest possible wearing comfort with the best possible Effect on the tone of the masticatory muscles can be linked.
  • the preferred embodiment makes it possible to achieve fixation on almost all possible head shapes with only a few basic sizes of the external head apparatus and at the same time to achieve the desired therapeutic effect. Since the symmetry of the facial area is regularly a main factor for the aesthetic perception of people, corresponding preferred configurations have regularly been rated in practice as visually appealing, which can significantly increase the end-user acceptance of wearing the external head apparatus.
  • An external head apparatus is preferred (preferably as referred to above as preferred), with the two separate connecting elements of the external head apparatus being arranged on the back of the head after the external head apparatus has been fixed to a human head.
  • Correspondingly preferred external head devices are particularly advantageous because in practice they are regularly assessed as being particularly visually appealing, as a result of which the end user acceptance for wearing the external head device can be significantly increased.
  • the preferred configuration of the external head apparatus enables the most advantageous power transmission through the bent, spring-hard wires.
  • the ability to fix the external head apparatus independently is most advantageous when the connecting elements are on the back of the head, which also means a certain basic distance from the supports on the muscles.
  • An external head apparatus is preferred (preferably as referred to above as preferred), the separate connecting elements being at a distance from one another that is greater than 5%, preferably greater than 10%, particularly preferably greater than 15, based on the longest bent, spring-hard wire %, is based on the length of the corresponding bent spring-hard wire and / or wherein the bent spring-hard wires in the area between the separate connecting elements run essentially parallel to one another.
  • Correspondingly preferred external head devices are particularly advantageous because they have proven to be particularly durable and resilient in practice. With appropriate designs, the advantages described above are particularly pronounced Validity.
  • the specified minimum distances alone or in combination with the parallel guidance of the bent, spring-hard wires between the two separate connecting elements on the back of the head have proven to be particularly pleasant in terms of wearing properties in our own tests.
  • Preferred embodiments with a parallel guide of the bent, spring-hard wires between the two separate connecting elements can also be produced in a particularly time-efficient manner, in particular from kits according to the invention, because the wires running between the separate connecting elements do not have to be rotated relative to one another in this area.
  • An external head apparatus according to the invention is preferred (preferably as described above as preferred), the distance between the separate connecting elements being different with respect to the two bent, spring-hard wires.
  • Correspondingly preferred external head apparatuses are particularly advantageous because a corresponding arrangement of the connecting elements creates a further possibility of influencing the application of pressure to the muscles by the supports arranged at the ends of the bent, spring-hard wires.
  • a corresponding arrangement of the connecting elements creates a further possibility of influencing the application of pressure to the muscles by the supports arranged at the ends of the bent, spring-hard wires.
  • two spring-hard wires of the same length that are identical in terms of their basic mechanical properties, a different mechanical behavior can be generated if two rigid connecting elements on one wire are close together and for the other wire are far apart, i.e. closer to the requirements.
  • an even more individual adaptation of the external head apparatus to the individual patient needs is possible.
  • An external head apparatus is preferred (preferably as referred to above as preferred), the separate connecting elements being set up to allow the distance between the two bent spring-hard wires to be changed, and / or where the separate connecting elements are connected to the bent spring-hard wires in this way are connected that a rotation of the connecting element around the bent federhar th wire is possible.
  • Correspondingly preferred external head appliances are particularly advantageous because they are particularly practical in everyday use and can be adapted particularly easily by the patient himself. Due to the possibility of changing the distance between the two bent, spring-hard wires by adjusting the connecting elements (e.g.
  • the patient has the particularly flexible option of changing the wearing properties adapt to his individual needs.
  • people with different head sizes and / or shapes can use a common external head apparatus, which can be particularly advantageous in hospitals when the patients are subject to a certain fluctuation and only a limited number of external head apparatus is available.
  • the possibility of rotating the connecting elements around the bent, spring-hard wire not only gives the entire head apparatus a certain flexibility and the ability to better absorb impacts, but also allows the entire external head apparatus to be folded flat and stored in a particularly space-saving manner.
  • An external head apparatus is preferred (preferably as referred to above as preferred), wherein the bent, spring-hard wires are coated with an organic or inorganic protective layer and / or where the bent, spring-hard wires are provided with a plastic coating.
  • Correspondingly preferred external head devices are particularly advantageous because the resistance of the bent, spring-hard wires to superficial oxidation is increased by the protective layer. Even if this oxidation usually does not have any negative effects on the durability of the external head equipment, in some cases it is interpreted by end users as damage or at least as an expression of poor processing quality, which leads to unnecessary complaints. Avoiding oxidation is therefore particularly advantageous. Coating with a plastic coating also has the advantage that it not only protects the wire, but also a purely cosmetic coating, for example a colored lacquer, which may be underlying it. In addition, many patients prefer the feeling of plastic against the skin over the feeling of metal.
  • An external head apparatus is preferred (preferably as referred to above as preferred), the pressure exerted on the masseter muscles by the supports when the external head apparatus is fixed to a human head is less than 60 kPa, preferably less than 30 kPa, particularly preferably less than 15 kPa.
  • Correspondingly preferred external head devices are particularly advantageous because, according to our own findings, the application of too high a pressure does not have an advantageous effect on the therapeutic benefit, but on the other hand could possibly be connected with other disadvantages.
  • the basic principle and recipe for success of the external head apparatus according to the invention is to lower the tone of the masticatory muscles through continuous gentle loading of the masticatory muscles without the use of high pressures, such as those required for massaging devices (see, for example, DE10201 1016505 A1). In this respect, corresponding preferred external head devices are particularly gentle on the patient.
  • An external head apparatus is preferred (preferably as referred to above as preferred), the supports arranged at the ends of the bent, spring-hard wires being provided with a macroscopically structured support surface, so that the supports along the longest when the external head apparatus is fixed to the human head Extension of the contact surface on the human head generate an uneven pressure profile, in particular with a macroscopically structured contact surface that has three or more elevations and two or more valleys in the axial section through the center of the support and / or wherein the supports with electrically operated functional elements are provided, preferably with heating elements and / or vibration elements and / or sensor elements and / or means for electrical stimulation of muscles.
  • Correspondingly preferred external head appliances are particularly advantageous because our own tests have shown that in certain patients who have been suffering from CMD symptoms for a relatively long time and who also have the proportional muscular stress on the two large masseter muscles, the masseter and temporalis muscles, deviates from the norm in the chewing movement, and the use of non-preferred head devices according to the invention can lead to an increased probability of headaches. A reduced headache tendency and an increased therapeutic efficacy were found for these patients.
  • the supports are provided with a macroscopically structured support surface.
  • a macroscopically structured support surface can be produced by attaching two concentric plastic rings with different diameters to the support.
  • the present invention also relates to a kit for producing an external head apparatus according to the invention, comprising
  • a one or more blanks comprising two spring-hard wires, wherein the spring-hard wires are connected to one another via two separate connecting elements, and
  • a kit according to the invention allows optimal and efficient distribution of the external head devices according to the invention and offers the greatest benefit for the patient.
  • the best results can be achieved with the external head apparatus according to the invention, according to the prevailing opinion, in those cases in which these are directly tailored to the needs of the patient by the attending physician or physiotherapist and are regularly adapted to changed circumstances in the course of therapy.
  • the manufacture of an external head apparatus according to the invention does not pose any particular difficulties for a person skilled in the art, for example manufacturing technology, in an average workshop, this manufacture, disadvantageously, cannot be fully transferred to an average practice, even if they have well-equipped laboratories.
  • the kit according to the invention comprises a blank in which the two spring-hard wires are already connected by two separate connecting elements and are each provided with supports at their ends.
  • the spring-hard wires in the blank must be bent into the final shape and / or cut to the correct length, depending on requirements.
  • This patient-dependent deformation of the blank i.e. the final adaptation to the individual patient
  • the doctor or physiotherapist uses the tool that is optimally adapted to the wire, which a specialist in manufacturing technology (especially if the manufacturer's information is available) can easily be selected .
  • the four or more supports for arrangement at the ends of the spring-hard wires in a kit according to the invention can also already be arranged on the ends of the spring-hard wires, especially if the doctor or physiotherapist only needs to bend them the blanks and no cutting to length.
  • kits according to the invention result from the above statements on preferred external head devices, the blank in each case being adapted accordingly.
  • the present invention also relates to a system comprising an external head apparatus according to the invention and at least one additional elastic or reclosable connecting element for connecting the two bent, spring-hard wires after the external head apparatus has been fixed to a human head, and / or a padded or unpadded cover made of fabric or leather to increase comfort.
  • Corresponding systems offer an even greater level of comfort.
  • the additional elastic or reclosable connecting element for example a rubber band or a tape with Velcro, for connecting the two bent, spring-hard wires is used after the external head apparatus has been fixed to a human head to fix the external head apparatus particularly firmly on the head.
  • the external head apparatus can also be used in phases of high stress, e.g. when sleeping or exercising, because the external head apparatus can no longer or at least less easily slip.
  • a padded or unpadded cover made of fabric or leather can be pulled over the external head apparatus. Surveys have shown that patients regularly prefer the feeling of fabric or leather on the skin over the feeling of metal or plastic. The wearing comfort is particularly increased if the cover is also padded.
  • FIG. 1 shows an external head apparatus according to the prior art, in which two bent, spring-hard wires (1, 2) are connected to one another with only a single separate connecting element (3), with supports (5) at both ends of the bent spring-hard wires. are arranged.
  • Figures 2 and 3 show an embodiment of an inventive external head apparatus in which two bent spring-hard wires (1, 2) are connected according to the invention with two separate connecting elements (3, 4), again at both ends of the bent spring-hard wires Conditions (5) are arranged.
  • the bent, spring-hard wires (1, 2) are connected to one another by the separate connecting elements (3, 4) in such a way that the external head apparatus can be fixed to a human head.
  • Aspect 1 relates to an external head apparatus for lowering the tone of the masticatory muscles in patients with bruxism and / or other craniomandibular dysfunction (CMD), comprising two bent, spring-hard wires that are connected to one another by two separate connecting elements, with the curved one at both ends
  • Spring-hard wires supports are arranged, the spring-hard wires have a length of 25 to 48 cm, preferably 28 to 44 cm, the separate connecting elements have a length of 4 to 10 cm, preferably 5 to 8 cm, the distance of the supports at the two ends of a bent spring-hard wire to each other is 5 to 11 cm, preferably 7 to 9 cm, with the two separate connecting elements at a distance of 3 to 8 cm, preferably 4 to 6 cm, from each other, the external head apparatus has a plane of symmetry that intersects the two bent spring-hard wires.
  • Aspect 2 relates to an external head apparatus according to aspect 1, wherein the bent, spring-hard wires consist of a stainless steel, and / or wherein the connecting elements consist of a material selected from the group consisting of engineering and high-performance plastics, preferably selected from the group consisting of PEEK, PA, POM, PC and PEK, and / or where the pads consist of a material which is selected from the group consisting of engineering and high-performance plastics, preferably selected from the group consisting of PEEK, PA, POM, PC and PEK.
  • Aspect 3 relates to an external head apparatus according to one of aspects 1 or 2, the two separate connecting elements being at a distance of 8 to 22 cm, preferably 10 to 20 cm, to the closest support relative to each of the two bent, spring-hard wires.
  • Aspect 4 relates to an external head apparatus according to one of aspects 1 to 3, the bent, spring-hard wires running essentially parallel to one another in the area between the separate connecting elements.
  • Aspect 5 relates to an external head apparatus according to one of aspects 1 to 4, the stand being different between the separate connecting elements with respect to the two bent, spring-hard wires.
  • Aspect 6 relates to an external head apparatus according to one of aspects 1 to 5, wherein the separate connecting elements are set up to allow a change in the distance between the two bent, spring-hard wires and / or wherein the separate connecting elements are so connected to the bent, spring-hard wires Wires are connected that a rotation of the connecting element around the bent spring-hard wire is possible.
  • Aspect 7 relates to an external head apparatus according to one of aspects 1 to 6, wherein the bent spring-hard wires are coated with an organic or inorganic protective layer and / or wherein the bent spring-hard wires are provided with a plastic coating.
  • Aspect 8 relates to an external head apparatus according to one of aspects 1 to 7, wherein the supports arranged at the ends of the bent, spring-hard wires are provided with a macroscopically structured support surface, in particular with a macroscopically structured support surface which, in an axial section through the center of the support has three or more elevations and two or more valleys and / or wherein the pads are provided with electrically operated functional elements, preferably with heating elements and / or vibration elements and / or sensor elements and / or means for electrical stimulation of muscles.
  • Aspect 9 relates to a kit for producing an external head apparatus according to one of aspects 1 to 8, comprising A one or more blanks, comprising two spring-hard wires, the spring-hard wires being connected to one another via two separate connecting elements, and B four or more supports for arrangement at the ends of the spring-hard wires, and C a bending tool for shaping the spring-hard wires and / or a cutting tool for cutting the spring-hard wires to length, and optionally D a work instruction for shaping and / o cutting the spring-hard wires to length.
  • Aspect 10 relates to a system comprising an external head apparatus according to one of aspects 1 to 8 and at least one additional elastic or reclosable connec tion element for connecting the two bent, spring-hard wires after the external head apparatus has been fixed to a human head, and / or a padded or unsealed head - padded cover made of fabric or leather for increased comfort.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Rehabilitation Therapy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Epidemiology (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

La présente invention concerne un appareil externe amélioré pour la tête, permettant de faire baisser le tonus des muscles de la mâchoire chez des patients atteints de bruxisme et/ou d'autres dysfonctionnements crânio-mandibulaires (DCM), l'appareil comprenant deux fils élastiques incurvés et deux éléments de liaison séparés, l'appareil externe pour la tête présentant un plan de symétrie qui passe au milieu des fils élastiques incurvés, et les deux éléments de liaison séparés étant disposés sur des côtés différents du plan de symétrie.
EP20714514.5A 2019-03-27 2020-03-23 Appareil externe pour la tête, permettant de faire baisser le tonus des muscles de la mâchoire chez des patients atteints de bruxisme et/ou d'autres dysfonctionnements crânio-mandibulaires (dcm) Pending EP3946181A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE202019001429.2U DE202019001429U1 (de) 2019-03-27 2019-03-27 Externe Kopfapparatur zur Senkung des Tonus der Kaumuskulatur bei Patienten mit Bruxismus und/oder anderen craniomandibulären Dysfunktionen (CMD)
DE102019002200.9A DE102019002200A1 (de) 2019-03-27 2019-03-27 Externe Kopfapparatur zur Senkung des Tonus der Kaumuskulatur bei Patienten mit Bruxismus und/oder anderen craniomandibulären Dysfunktionen (CMD)
PCT/EP2020/057948 WO2020193465A1 (fr) 2019-03-27 2020-03-23 Appareil externe pour la tête, permettant de faire baisser le tonus des muscles de la mâchoire chez des patients atteints de bruxisme et/ou d'autres dysfonctionnements crânio-mandibulaires (dcm)

Publications (1)

Publication Number Publication Date
EP3946181A1 true EP3946181A1 (fr) 2022-02-09

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EP20714514.5A Pending EP3946181A1 (fr) 2019-03-27 2020-03-23 Appareil externe pour la tête, permettant de faire baisser le tonus des muscles de la mâchoire chez des patients atteints de bruxisme et/ou d'autres dysfonctionnements crânio-mandibulaires (dcm)

Country Status (3)

Country Link
US (1) US20220151818A1 (fr)
EP (1) EP3946181A1 (fr)
WO (1) WO2020193465A1 (fr)

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WO2020193465A1 (fr) 2020-10-01
US20220151818A1 (en) 2022-05-19

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