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WO2025136322A2 - An air-inflated spinal orthosis mechanism and operation method thereof - Google Patents

An air-inflated spinal orthosis mechanism and operation method thereof Download PDF

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Publication number
WO2025136322A2
WO2025136322A2 PCT/TR2024/051593 TR2024051593W WO2025136322A2 WO 2025136322 A2 WO2025136322 A2 WO 2025136322A2 TR 2024051593 W TR2024051593 W TR 2024051593W WO 2025136322 A2 WO2025136322 A2 WO 2025136322A2
Authority
WO
WIPO (PCT)
Prior art keywords
pocket
inner tube
air
spinal
spinal orthosis
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
PCT/TR2024/051593
Other languages
French (fr)
Other versions
WO2025136322A3 (en
Inventor
Sena OZDEMIR GORGU
Berkay KAYA
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.)
Istanbul Medipol Universitesi
Original Assignee
Istanbul Medipol Universitesi
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 TR2023/018160 external-priority patent/TR2023018160A2/en
Application filed by Istanbul Medipol Universitesi filed Critical Istanbul Medipol Universitesi
Publication of WO2025136322A2 publication Critical patent/WO2025136322A2/en
Publication of WO2025136322A3 publication Critical patent/WO2025136322A3/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/01Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/02Orthopaedic corsets
    • A61F5/024Orthopaedic corsets having pressure pads connected in a frame for reduction or correction of the curvature of the spine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/01Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/30Pressure pads
    • A61F5/34Pressure pads filled with air or liquid

Definitions

  • the present invention relates to a spinal orthosis mechanism suitable for use in children, adults, and geriatric individuals with spinal deformities (e.g. scoliosis, kyphosis) due to orthopedic, neurological, pediatric, rheumatological diseases, which applies a corrective force to at least one region of the user's spine with a certain air pressure, and operation method thereof.
  • spinal deformities e.g. scoliosis, kyphosis
  • spinal deformities are classified as structural and non-structural.
  • Structural deformities such as idiopathic scoliosis, Schuermann's kyphosis, congenital vertebral malformation, spinal osteomyelitis, and spondylolisthesis cause postural disorders.
  • Moderately mobile spinal deformities in which the patient can actively change his posture are defined as functional or non- structural spinal deformities.
  • Non-structural spinal deformities are functional scoliosis, lordosis, and kyphosis due to incorrect postural habits and/or decreased muscle strength. These deformities can be seen alone or together.
  • spinal orthosis is the most commonly used conservative treatment method in the conservative treatment of spinal deformity and/or scoliosis and provide effective results when applied correctly.
  • spinal orthosis treatment is a conservative treatment method whose effectiveness has been proven in stopping or reducing the progression of curvature in scoliosis.
  • spinal orthoses are designed according to different biomechanical principles, the 3- point principle forms the basis. These 3 points are formed by 3 compression forces; the first pressure is applied from the upper part of the deformity, the second pressure is applied from the lower part of the deformity, and the third pressure is applied from the apex of the curvature (in contrast to other forces) (The place where the curvature is most angled, that is, where the vertebrae that deviate the most from the vertical axis and move the most away from the middle spinal line are called the apex or peak).
  • the effectiveness of spinal orthosis treatment depends on factors such as the application of intra-orthosis correction force, bone maturation (development), degree of curvature and the individual's compatibility with the corset.
  • spinal orthosis designs are available, and the average daily usage times also vary from person to person. It is reported that the duration of spinal orthosis use, in which the best results are observed in the treatment of spinal orthosis, is 23 hours.
  • spinal orthosis types in the form of hard spinal orthoses (used 8-12 hours a day), soft spinal orthoses, part-time hard spinal orthoses (used 12-20 hours a day) and full-time hard spinal orthoses (used 20-24 hours a day).
  • Rigid spinal orthoses are made of plastazote, many metals and plastic materials. For example, metals are separated into ferrous and non-ferrous. Iron-containing (spring steels, low-added construction steels, stainless steels), non-ferrous (aluminum, duralumin, titanium), and plastics are thermoset plastics (epoxies, polyester, silicone, polyurethane foam) thermoplastics (high- temperature thermoplastics, low-temperature thermoplastics, other materials). The main issues affecting the hardness here are the type of material, the cooking temperature, the density of the material used, etc.
  • the object of the present invention is to realize a spinal orthosis mechanism comprising the material in which more stretchable fabrics are used compared to the spinal orthoses used in the state of the art, which does not cause sweating, pain, and any restriction in the motions of the user, does not visually disturb, and provides the elimination of posture disorders by applying an effective treatment to the spine with an air pressure of a predetermined value.
  • Figure 1 A representative side view of the positive pressure supply unit that provides air to the inner tube of the orthosis mechanism of the invention, together with the components it contains.
  • Figure 2 A representative side view of the positive pressure unit with the piston part moving.
  • Figure 3 A rear view of the orthosis dressed on the body.
  • Figure 4 A front view of the orthosis containing at least one inner tube, dressed on the body.
  • Figure 5 A representative top view of the second pocket in an enlarged form.
  • Figure 6 A representative top view of the inner tube before air is applied.
  • Figure 7 A representative inflated (aired) side view of the inner tube.
  • Figure 8 A representative top view of the inner tube placed in the second pocket.
  • Figure 9 An inflated representative side view of the inner tube placed in the second pocket.
  • FIG. 10 An enlarged representative perspective view of the Velcro tape used as the fastening unit in an embodiment of the invention.
  • Figure 11 A rear representative view of the entire orthosis mechanism in which a positive pressure unit is attached to at least one inner tube containing the orthosis and the orthosis is dressed on the body.
  • Figure 12 A view of the front inner part of the orthosis containing the second pocket with at least one inflated inner tube.
  • Figure 13 A representative view of the forces applied to the spine of an exemplary scoliosis patient with an orthosis.
  • Positive pressure supply unit 2.1. Battery unit
  • the spinal orthosis mechanism (10) of the invention comprises at least one spinal orthosis (1) to correct the deformity in more than one spinal region at the same time, at least one positive pressure supply unit (2) that generates a predetermined air pressure for the spinal orthosis (1) to correct the specified deformity, at least one connection pipe (3) that provides the connection between said spinal orthosis (1) and the positive pressure supply unit (2) and transmits the air pressure produced by the positive pressure supply unit (2) to the spinal orthosis (1).
  • Said spinal orthosis (1) comprises the following: at least one wearable material (1.1), at least one first pocket (1.2) positioned perpendicular to the ground, above the spine axis and parallel to the spine axis in the form of an hourglass of a predetermined size on the wearable material (1.1) and coinciding with at least one defective location in the spine on the back of the body, at least one second pocket (1.3) in a predetermined form located on the back of the body on at least one defective location in the spine, in the form of a predetermined hexagon of a predetermined size with two opposite sides of a predetermined length shorter than the other sides, and placed with the short side facing the spine axis, and at a predetermined distance from the axis to the right and/or left side of the spine axis, at least one bladder (1.4) of a predetermined size, which can be inflated and deflated by the air pressure generated for each first pocket (1.2) and/or second pocket (1.3), smaller than the first pocket (1.2) and/or second pocket (1.3
  • the first pressure sensing unit (1.2.1) is positioned in one of the triangular regions of the first pocket (1.2) in the form of an hourglass, preferably in the region above when worn on the body.
  • the second pocket (1.3) comprises at least one second pressure sensing unit (1.3.1) and at least one inner tube insertion part (1.3.2).
  • the second pressure sensing unit (1.3.1) is positioned parallel to one of the edges of the second pocket (1.3), which is in the form of a hexagon, relative to the other edges.
  • the inner tube (1.4) is suitable to be inserted from the inner tube insertion part
  • Said inner tube (1.4) comprises at least one air discharge valve (1.4.1) positioned to protrude from the first inner tube insertion part (1.2.2) and/or the second inner tube insertion part (1.3.2) when placed in the first pocket
  • connection pipe inlet positioned to connect the connection pipe (3) from the first inner tube insertion part (1.2.2) and/or the second inner tube insertion part (1.3.2). Thanks to the shape of the first pocket (1.2), air pressure is applied to a large part of the back, that is, the thoracic spine, to cover many spines longitudinally for kyphosis patients.
  • the spinal orthosis (1) comprises at least three fastening units (1.5) positioned to allow the spinal orthosis (1) to be closed by wearing the spinal orthosis (1) on each shoulder and the front of the body in order to fully comply with the body size.
  • the wearable material (1.1) comprises an inelastic material that has the property of stretching in the areas in contact with the body in the areas where the air pressure will affect but is a doublelayer soft nylon fabric with predetermined thin holes that is frequently woven in all remaining areas. This is to channel the pressure directly into that area. Nylon does not get wet because it does not retain water. Holes also allow the body to breathe. It does not stretch due to its double layer and frequent touch (The unperforated form of this fabric is used as a sleeve in sphygmomanometers).
  • the connection pipe (3) is made of a flexible material.
  • the fastening unit (1.5) is at least one Velcro tape in one embodiment of the invention.
  • the spinal orthosis (1) of the invention comprises six second pockets (1.3) positioned at a predetermined distance with each other and with the spinal axis in the preferred embodiment of the invention. This has the advantage that it is suitable for every user whose spine deformity is located in different places.
  • the positive pressure supply unit (2) comprises at least one battery unit (2.1) that provides electrical energy, at least one electric motor (2.2) that has connection with the batter unit (2.1) and converts the electrical energy received from the battery unit (2.1) into rotational motion, at least one switch (2.3) that enables the electric motor (2.2) to open and close, at least one rotational motion transfer unit (2.4) that carries the rotational motion received from the electric motor (2.2) from the horizontal axis to the vertical axis and vice versa, at least one perforated nut (2.5) that starts to rotate by taking the rotational motion from the rotational motion transfer unit (2.4), at least one motion transfer rod (2.6) that is attached to the hole of the perforated nut (2.5) and converts the rotational motion therein into a push-pull motion, and at least one piston container (2.7) that is airtight.
  • the piston container (2.7) comprises at least one piston (2.7.1) that receives the push-pull motion and generates air with this motion, at least one valve (2.7.2) that provides the one-way outlet of the air it receives from the piston (2.7.1) and prevents the air from escaping back, and at least one air outlet pipe (2.7.3) that transfers the air it receives from this valve (2.7.2) to the inner tube (1.4) contained in the spinal orthosis (1) through the connection Pipe (3).
  • Said rotational motion transfer unit (2.4) is at least two wheels in one embodiment.
  • the positive pressure supply unit (2) is at least one air pump in one embodiment.
  • the motion transfer rod (2.6) is made of iron material from one embodiment.
  • the inner tube (1.4) is connected to the air outlet pipe (2.7.3) of the positive pressure supply unit (2) by attaching the connection pipe (3) from the connection pipe inlet (1.4.2).
  • the air compressed from the positive pressure supply unit (2) exits the air outlet pipe (2.7.3) and reaches the inner tube (or inner tubes) (1.4) placed in the first pocket (1.2) from the first inner tube insertion part (1.2.2) and/or the second inner tube insertion part (1.3.2) in the second pocket (1.3) through the connection pipe (3) and inflates it.
  • the inner tube (1.4) inflates, the air pressure formed in it increases and the resulting air pressure exerts a corrective force on the relevant part of the spine.
  • the amount of the applied pressure is calculated by the first pressure sensing unit (1.2.1) included in the first pocket (1.2) and/or the second pressure sensing unit (1.3.1) included in the second pocket (1.3), the user can preferably display this calculated pressure value from at least one interface (A) (not shown in the figures) and the pressure amount can be increased or decreased according to the user's needs.
  • the air compressed in the inner tube (1.4) can be reduced or completely discharged by the air discharge valve (1.4.1).
  • the inner tube (1.4) positioned in the first pocket (1.2) and/or the second pocket (1.3) in that region can be inflated where pressure needs to be applied.
  • the first pocket (1.2) and the body-contacting part of the second pocket (1.3) are flexible and made of Lycra fabric, and the outer part is made of rigid material. Thanks to the flexibility, the pressure of the first pocket (1.2) and the inner tube (1.4) in the second pocket (1.3) acts by channeling it completely into the body. Stiffness prevents the inflating inner tube (1.4) from curling from the outside, that is, from being seen from the outside. Thus, the person wearing the spinal orthosis (1) is prevented from being negatively affected socially.
  • connection of said unit (2) can be removed, it is better in terms of appearance and the patient is prevented from being affected in terms of weight. Since the user can take a shower, the electronic components will not be damaged. A dress worn on the orthosis will not look bad from the outside because it does not protrude on the body.
  • the outer structure is of an easy to wear material, for example, the wearable material (1.1) may be in a form such as a t-shirt, undershirt.
  • the part of the pockets that does not come into contact with the body is designed so as not to allow the inner tubes (1.4) to protrude from the outside.
  • the worn spinal orthosis (1) will not cause an unaesthetic appearance from the outside. Due to the thin structure of the spinal orthosis (1), other clothes can be worn easily, which will ensure that the product can be used for days without removing it. It is also an advantage that it can be washed easily.
  • the operation method (100) of the spinal orthosis mechanism of the invention comprises the following steps:
  • At least one inner tube (1.4) is placed in at least one first pocket
  • the positive pressure supply unit (2) is connected to the connection pipe inlet (1.4.2) of the inner tube (1.4.4) via the connection pipe (3),
  • air is pumped into the inner tube (1.4) via the positive pressure supply unit (2) to inflate the inner tube (1.4) positioned in the first pocket (1.2) and/or the second pocket (1.3), depending on the type of posture disorder in the body, i.e. where pressure needs to be applied,
  • the compressed air is checked with the first pressure sensing unit (1.2.1) and/or the second pressure sensing unit (1.3.1),
  • the positive pressure supply unit (2) continues to supply air
  • the necessary amount of air is discharged by the air discharge valve (1.4.1),
  • the wearable material (1.1) is worn by the user and adjusted and/or closed from the shoulders by means of the fastening unit (1.5).
  • the electric motor (2.2) is started by means of the switch (2.3) and the electric motor (2.2) starts to receive electrical energy from the battery unit (2.1),
  • the rotational motion transfer unit (2.4) transfers the rotational motion from the horizontal axis to the vertical axis or vice versa
  • the perforated nut (2.5) starts to rotate by taking the rotational motion from the rotational motion transfer unit (2.4),
  • the motion transfer rod (2.6) installed in the hole of the perforated nut (2.5) converts the rotational motion of the perforated nut (2.5) into a push-pull motion
  • the piston (2.7.1) receives the push-pull motion and generates air with this motion
  • the valve (2.7.2) receives the air produced by the piston (2.7.1) and delivers it unidirectionally to the air outlet pipe (2.7.3),
  • the air outlet pipe (2.7.3) transfers the air to the inner tube (1.4) in the spinal orthosis (1) through the connecting pipe (3) and inflates the inner tube.
  • the present invention relates to a spinal orthosis mechanism (10) suitable for use in children, adults, and geriatric individuals with spinal deformities (e.g. scoliosis, kyphosis) due to orthopedic, neurological, pediatric, rheumatological diseases, which applies a corrective force to the relevant areas of the user's spine with air pressure, and its operation method, and is applicable to the industry.
  • spinal deformities e.g. scoliosis, kyphosis

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Abstract

The present invention relates to a spinal orthosis mechanism (10) suitable for use in children, adults, and geriatric individuals with spinal deformities (e.g. scoliosis, kyphosis) due to orthopedic, neurological, pediatric, rheumatological diseases, which applies a corrective force to at least one region of the user's spine with a certain air pressure, and operation method (100) thereof.

Description

AN AIR-INFLATED SPINAL ORTHOSIS MECHANISM AND OPERATION METHOD THEREOF
Technical Field
The present invention relates to a spinal orthosis mechanism suitable for use in children, adults, and geriatric individuals with spinal deformities (e.g. scoliosis, kyphosis) due to orthopedic, neurological, pediatric, rheumatological diseases, which applies a corrective force to at least one region of the user's spine with a certain air pressure, and operation method thereof.
State of the Art
Clinically, spinal deformities are classified as structural and non-structural. Structural deformities such as idiopathic scoliosis, Schuermann's kyphosis, congenital vertebral malformation, spinal osteomyelitis, and spondylolisthesis cause postural disorders. Moderately mobile spinal deformities in which the patient can actively change his posture are defined as functional or non- structural spinal deformities. Non-structural spinal deformities are functional scoliosis, lordosis, and kyphosis due to incorrect postural habits and/or decreased muscle strength. These deformities can be seen alone or together.
Conservative treatment (surgical or non-invasive) in spinal deformities is divided into two titles as spinal orthosis (corset) and physiotherapy applications. Spinal orthoses are the most commonly used conservative treatment method in the conservative treatment of spinal deformity and/or scoliosis and provide effective results when applied correctly. In the literature, spinal orthosis treatment is a conservative treatment method whose effectiveness has been proven in stopping or reducing the progression of curvature in scoliosis.
Although spinal orthoses are designed according to different biomechanical principles, the 3- point principle forms the basis. These 3 points are formed by 3 compression forces; the first pressure is applied from the upper part of the deformity, the second pressure is applied from the lower part of the deformity, and the third pressure is applied from the apex of the curvature (in contrast to other forces) (The place where the curvature is most angled, that is, where the vertebrae that deviate the most from the vertical axis and move the most away from the middle spinal line are called the apex or peak). The effectiveness of spinal orthosis treatment depends on factors such as the application of intra-orthosis correction force, bone maturation (development), degree of curvature and the individual's compatibility with the corset.
Various spinal orthosis designs are available, and the average daily usage times also vary from person to person. It is reported that the duration of spinal orthosis use, in which the best results are observed in the treatment of spinal orthosis, is 23 hours. In the literature, there are spinal orthosis types in the form of hard spinal orthoses (used 8-12 hours a day), soft spinal orthoses, part-time hard spinal orthoses (used 12-20 hours a day) and full-time hard spinal orthoses (used 20-24 hours a day).
Rigid spinal orthoses are made of plastazote, many metals and plastic materials. For example, metals are separated into ferrous and non-ferrous. Iron-containing (spring steels, low-added construction steels, stainless steels), non-ferrous (aluminum, duralumin, titanium), and plastics are thermoset plastics (epoxies, polyester, silicone, polyurethane foam) thermoplastics (high- temperature thermoplastics, low-temperature thermoplastics, other materials). The main issues affecting the hardness here are the type of material, the cooking temperature, the density of the material used, etc.
In the state of the art, a bone orthosis arch that swells with air and is used for foot treatment is given in the link "https://tr.dhgate.com/product/inflatable-air-compression-hallux- valgus/560679072.html". The product is used only for foot treatment and the orthosis is inflated by generating positive pressure with a flexible manual pump with a manual squeeze-release motion. Manual inflation of the orthosis is both ineffective and exhausting. Its use only for the foot is also a disadvantage. In addition, there is no sensor in which the amount of pressure is calculated. The inability to calculate the pressure prevents its use in academic studies because it will not provide an objective evaluation. Since the apparatus that provides inflation cannot be removed, it cannot be used outside the house.
The link “https://tr.aliexpress.eom/i/1005002812790386.html”, which is another state of the art, also gives an air-inflated shoulder-supported spinal scoliosis posture corrector belt. In addition to having similar disadvantages to the above product, this product also has disadvantages such as not applying regional pressure, applying pressure to the entire back and waist region (thoracic and lumbar region) in an irreplaceable way, not being able to provide the 3 -point principle as a result of the effect of air pressure only on the areas that will correct the posture, inflating only a single region from a single entrance, since the pressures in the scoliosis orthoses are usually given from the sides of the body, not the back and chest region, and since the product in the link applies pressure from the back, it only works in posture disorders such as kyphosis, and has no effectiveness in scoliosis.
Although the effectiveness of the corset treatment applied in the current situation in individuals with scoliosis/spine deformity has been proven, it can cause individuals to face various difficulties in their daily life. One of these difficulties is that the psychological, social, and school life of individuals is negatively affected and causes stress. The long-term use of the corset and its physical characteristics, that is, its appearance, as well as the questions and/or attitudes of the social environment of the individuals about the corset, can have a negative effect on the individuals using the corset. Another disadvantage is that a corrective force is applied to the area of curvature (convex side) with the use of hard and airtight materials called metal and plastazote in rigid-hard spinal orthoses applied in the current situation, which causes complaints in terms of sweating, skin irritation, restriction of chest motions, pain and visuality and reduces the duration of use of the orthosis. Since these orthoses are molded and rigid due to their plastic structure, they are difficult to wear, and it is reported in the studies that they have negative effects on walking and balance. The orthoses used in the treatment of posture disorders should also be used for a long time in order to benefit the patient. However, these negative factors cause patients to refuse orthosis treatment. In the treatment of corset, the use of corset at the specified times and the effectiveness of the treatment are directly related. Therefore, in order to increase the effectiveness of the treatment, there is a need for spinal orthosis designs that individuals with scoliosis or spine deformity can use more comfortably and have a corrective effect on the deformity, as well as not be visually disturbing. On the other hand, there is a need for an orthosis that can be subjected to different diseases in more than one region at the same time, can be adjusted at the desired hardness (hard, medium-hard, soft) and is easy to use.
Brief Description of the Invention
The object of the present invention is to realize a spinal orthosis mechanism comprising the material in which more stretchable fabrics are used compared to the spinal orthoses used in the state of the art, which does not cause sweating, pain, and any restriction in the motions of the user, does not visually disturb, and provides the elimination of posture disorders by applying an effective treatment to the spine with an air pressure of a predetermined value.
With this invention, a more effective treatment will be applied with the air pressure applied and measured in the right directions by increasing user satisfaction, especially since the disadvantages of hard orthoses are eliminated. In particular, the daily orthosis usage time and the amount of pressure (force) applied can be monitored through the pressure sensing units in the present invention. In addition, individually adjustable forces (through air pressure) will be applied. On the other hand, an orthosis mechanism that has a corrective effect in more than one region at the same time and is easy to use and its operation method is provided by the invention.
Descriptions of the Figures
Figure 1: A representative side view of the positive pressure supply unit that provides air to the inner tube of the orthosis mechanism of the invention, together with the components it contains. Figure 2: A representative side view of the positive pressure unit with the piston part moving. Figure 3: A rear view of the orthosis dressed on the body.
Figure 4: A front view of the orthosis containing at least one inner tube, dressed on the body. Figure 5: A representative top view of the second pocket in an enlarged form.
Figure 6: A representative top view of the inner tube before air is applied.
Figure 7: A representative inflated (aired) side view of the inner tube.
Figure 8: A representative top view of the inner tube placed in the second pocket.
Figure 9: An inflated representative side view of the inner tube placed in the second pocket.
Figure 10: An enlarged representative perspective view of the Velcro tape used as the fastening unit in an embodiment of the invention.
Figure 11: A rear representative view of the entire orthosis mechanism in which a positive pressure unit is attached to at least one inner tube containing the orthosis and the orthosis is dressed on the body.
Figure 12: A view of the front inner part of the orthosis containing the second pocket with at least one inflated inner tube.
Figure 13: A representative view of the forces applied to the spine of an exemplary scoliosis patient with an orthosis.
Description of References in Figures
10. Spinal orthosis mechanism
1. Spinal orthosis
1.1. Wearable material
1.2. First pocket
1.2.1. First pressure sensing unit
1.2.2. First inner tube insertion part
1.3. Second pocket
1.3.1. Second pressure sensing unit
1.3.2. Second inner tube insertion part
1.4. Inner tube
1.4.1. Air discharge valve
1.4.2. Connection pipe inlet
1.5. Fastening unit
2. Positive pressure supply unit 2.1. Battery unit
2.2. Electric motor
2.3. Switch
2.4. Rotational motion transfer unit
2.5. Perforated nut
2.6. Motion transfer rod
2.7. Piston container
2.7.1. Piston
2.7.2. Valve
2.7.3. Air outlet pipe
3. Connection pipe
A. Interface
100. Method
Detailed Description of the Invention
The spinal orthosis mechanism (10) of the invention comprises at least one spinal orthosis (1) to correct the deformity in more than one spinal region at the same time, at least one positive pressure supply unit (2) that generates a predetermined air pressure for the spinal orthosis (1) to correct the specified deformity, at least one connection pipe (3) that provides the connection between said spinal orthosis (1) and the positive pressure supply unit (2) and transmits the air pressure produced by the positive pressure supply unit (2) to the spinal orthosis (1).
Said spinal orthosis (1) comprises the following: at least one wearable material (1.1), at least one first pocket (1.2) positioned perpendicular to the ground, above the spine axis and parallel to the spine axis in the form of an hourglass of a predetermined size on the wearable material (1.1) and coinciding with at least one defective location in the spine on the back of the body, at least one second pocket (1.3) in a predetermined form located on the back of the body on at least one defective location in the spine, in the form of a predetermined hexagon of a predetermined size with two opposite sides of a predetermined length shorter than the other sides, and placed with the short side facing the spine axis, and at a predetermined distance from the axis to the right and/or left side of the spine axis, at least one bladder (1.4) of a predetermined size, which can be inflated and deflated by the air pressure generated for each first pocket (1.2) and/or second pocket (1.3), smaller than the first pocket (1.2) and/or second pocket (1.3), and which can be displaced by sliding within the first pocket (1.2) and/or second pocket (1.3), and at least one fastening unit (1.5) that allows the spinal orthosis (1) to be closed after wearing. Said first pocket (1.2) comprises at least one first pressure sensing unit (1.2.1) and at least one inner tube insertion part
(1.2.2). The first pressure sensing unit (1.2.1) is positioned in one of the triangular regions of the first pocket (1.2) in the form of an hourglass, preferably in the region above when worn on the body. The second pocket (1.3) comprises at least one second pressure sensing unit (1.3.1) and at least one inner tube insertion part (1.3.2). The second pressure sensing unit (1.3.1) is positioned parallel to one of the edges of the second pocket (1.3), which is in the form of a hexagon, relative to the other edges. The inner tube (1.4) is suitable to be inserted from the inner tube insertion part
(1.2.2) into the first pocket (1.2) and/or the second pocket (1.3). Said inner tube (1.4) comprises at least one air discharge valve (1.4.1) positioned to protrude from the first inner tube insertion part (1.2.2) and/or the second inner tube insertion part (1.3.2) when placed in the first pocket
(1.2) and/or the second pocket (1.3), and at least one connection pipe inlet (1.4.2) positioned to connect the connection pipe (3) from the first inner tube insertion part (1.2.2) and/or the second inner tube insertion part (1.3.2). Thanks to the shape of the first pocket (1.2), air pressure is applied to a large part of the back, that is, the thoracic spine, to cover many spines longitudinally for kyphosis patients.
In one embodiment, the spinal orthosis (1) comprises at least three fastening units (1.5) positioned to allow the spinal orthosis (1) to be closed by wearing the spinal orthosis (1) on each shoulder and the front of the body in order to fully comply with the body size.
The wearable material (1.1) comprises an inelastic material that has the property of stretching in the areas in contact with the body in the areas where the air pressure will affect but is a doublelayer soft nylon fabric with predetermined thin holes that is frequently woven in all remaining areas. This is to channel the pressure directly into that area. Nylon does not get wet because it does not retain water. Holes also allow the body to breathe. It does not stretch due to its double layer and frequent touch (The unperforated form of this fabric is used as a sleeve in sphygmomanometers). The connection pipe (3) is made of a flexible material.
The fastening unit (1.5) is at least one Velcro tape in one embodiment of the invention.
The spinal orthosis (1) of the invention comprises six second pockets (1.3) positioned at a predetermined distance with each other and with the spinal axis in the preferred embodiment of the invention. This has the advantage that it is suitable for every user whose spine deformity is located in different places.
The positive pressure supply unit (2) comprises at least one battery unit (2.1) that provides electrical energy, at least one electric motor (2.2) that has connection with the batter unit (2.1) and converts the electrical energy received from the battery unit (2.1) into rotational motion, at least one switch (2.3) that enables the electric motor (2.2) to open and close, at least one rotational motion transfer unit (2.4) that carries the rotational motion received from the electric motor (2.2) from the horizontal axis to the vertical axis and vice versa, at least one perforated nut (2.5) that starts to rotate by taking the rotational motion from the rotational motion transfer unit (2.4), at least one motion transfer rod (2.6) that is attached to the hole of the perforated nut (2.5) and converts the rotational motion therein into a push-pull motion, and at least one piston container (2.7) that is airtight. The piston container (2.7) comprises at least one piston (2.7.1) that receives the push-pull motion and generates air with this motion, at least one valve (2.7.2) that provides the one-way outlet of the air it receives from the piston (2.7.1) and prevents the air from escaping back, and at least one air outlet pipe (2.7.3) that transfers the air it receives from this valve (2.7.2) to the inner tube (1.4) contained in the spinal orthosis (1) through the connection Pipe (3).
Said rotational motion transfer unit (2.4) is at least two wheels in one embodiment.
The positive pressure supply unit (2) is at least one air pump in one embodiment.
The motion transfer rod (2.6) is made of iron material from one embodiment. The inner tube (1.4) is connected to the air outlet pipe (2.7.3) of the positive pressure supply unit (2) by attaching the connection pipe (3) from the connection pipe inlet (1.4.2). Thus, the air compressed from the positive pressure supply unit (2) exits the air outlet pipe (2.7.3) and reaches the inner tube (or inner tubes) (1.4) placed in the first pocket (1.2) from the first inner tube insertion part (1.2.2) and/or the second inner tube insertion part (1.3.2) in the second pocket (1.3) through the connection pipe (3) and inflates it. As the inner tube (1.4) inflates, the air pressure formed in it increases and the resulting air pressure exerts a corrective force on the relevant part of the spine. The amount of the applied pressure is calculated by the first pressure sensing unit (1.2.1) included in the first pocket (1.2) and/or the second pressure sensing unit (1.3.1) included in the second pocket (1.3), the user can preferably display this calculated pressure value from at least one interface (A) (not shown in the figures) and the pressure amount can be increased or decreased according to the user's needs. When the pressure amount is desired to be reduced or after use, the air compressed in the inner tube (1.4) can be reduced or completely discharged by the air discharge valve (1.4.1). Depending on the type of posture disorder in the body, the inner tube (1.4) positioned in the first pocket (1.2) and/or the second pocket (1.3) in that region can be inflated where pressure needs to be applied.
On the other hand, the first pocket (1.2) and the body-contacting part of the second pocket (1.3) are flexible and made of Lycra fabric, and the outer part is made of rigid material. Thanks to the flexibility, the pressure of the first pocket (1.2) and the inner tube (1.4) in the second pocket (1.3) acts by channeling it completely into the body. Stiffness prevents the inflating inner tube (1.4) from curling from the outside, that is, from being seen from the outside. Thus, the person wearing the spinal orthosis (1) is prevented from being negatively affected socially.
In short, the working principle of the spinal orthosis mechanism (10) is as follows:
The above-mentioned 3 -point principle is applied. This principle is provided by the movable inner tubes (1.4) by adjusting them according to the curvature type of the user. For example, the air placed in the apex will be applied from the pressure point, while the other two opposing forces will be applied from the lower and upper points of the curve. The forces applied will be provided through pockets that can be changed. In the scoliosis patient shown as an example in Figure 13, the A and C forces are applied up and down the apex part, and the B force is applied from the full apex part. The force B is equal to the sum of the forces A and C. In standard hard orthoses, these forces are provided by plastazote-hard pads, while in the spinal orthosis mechanism (10) of the invention, these forces are provided by air pressure.
In summary, the innovations, and advantages of the spinal orthosis mechanism (10) of the invention compared to other orthoses are as follows:
• It is primarily designed to meet all types of orthoses used in the treatment of scoliosis. It can be adjusted according to the need (soft orthosis-moderate orthosis-hard orthosis). As the angle of scoliosis decreases, it will completely eliminate making a new orthosis continuously. All that needs to be done is to reduce the pressure.
• Another advantage is that the pressure zones applied according to the region of the scoliosis can be changed. The desired adjustment can be made according to the region in which the pressure needs to be applied, not a fixed region.
• Thanks to the first and second pressure sensing units (1.2.1, 1.3.1), the development of the patient can be monitored thanks to the adjustment of the pressure amount. These values will ensure that this orthosis is preferred in scientific studies.
• It is practical to inflate the inner tubes (1.4) contained in the spinal orthosis (1) with the positive pressure supply unit (2).
• At the same time, thanks to the fact that the connection of said unit (2) can be removed, it is better in terms of appearance and the patient is prevented from being affected in terms of weight. Since the user can take a shower, the electronic components will not be damaged. A dress worn on the orthosis will not look bad from the outside because it does not protrude on the body.
• It is not only used in scoliosis patients, but also protects people who spend hours at the desk against kyphosis thanks to the air pressure applied from the shoulder and back. It treats people with kyphosis.
• The outer structure is of an easy to wear material, for example, the wearable material (1.1) may be in a form such as a t-shirt, undershirt. The part of the pockets that does not come into contact with the body is designed so as not to allow the inner tubes (1.4) to protrude from the outside. For this reason, the worn spinal orthosis (1) will not cause an unaesthetic appearance from the outside. Due to the thin structure of the spinal orthosis (1), other clothes can be worn easily, which will ensure that the product can be used for days without removing it. It is also an advantage that it can be washed easily.
• It does not cause sweating like plastic and metal orthoses.
• Since the air pressure will affect the areas that come into contact with the body, it will not cause discomfort such as plastic and metal orthoses.
• A single spinal orthosis (1) can be used in the treatment of many posture problems, which will save money economically.
• It is much lighter than metal and plastic orthoses due to the material used.
• The spinal orthosis mechanism (10) of the invention will be useful not only to eliminate posture disorders, but also to prevent posture disorders by using it in healthy individuals such as people with genetic predisposition or who may have an occupational disease.
• If the user has scoliosis, the duration of use may vary according to the scoliosis angle of the user, but since the present invention is softer than other orthoses, the duration of use may be up to 24 hours compared to other spinal orthoses. It is even suitable for bathing.
The operation method (100) of the spinal orthosis mechanism of the invention comprises the following steps:
In the first step, at least one inner tube (1.4) is placed in at least one first pocket
(1.2) and/or at least one second pocket (1.3) by sliding in the pockets when necessary, so that the air discharge valve (1.4.1) and the connection pipe inlet
(1.4.2) are excluded from the first inner tube insertion part (1.2.2) and/or the second inner tube insertion part (1.3.2),
In the second step, the positive pressure supply unit (2) is connected to the connection pipe inlet (1.4.2) of the inner tube (1.4.4) via the connection pipe (3), In the third step, air is pumped into the inner tube (1.4) via the positive pressure supply unit (2) to inflate the inner tube (1.4) positioned in the first pocket (1.2) and/or the second pocket (1.3), depending on the type of posture disorder in the body, i.e. where pressure needs to be applied,
In the fourth step, the compressed air is checked with the first pressure sensing unit (1.2.1) and/or the second pressure sensing unit (1.3.1),
In the fifth step, if the pressure amount is less than a predetermined value, the positive pressure supply unit (2) continues to supply air,
In the sixth step, if the pressure amount is more than a predetermined value, the necessary amount of air is discharged by the air discharge valve (1.4.1),
In the seventh step, the wearable material (1.1) is worn by the user and adjusted and/or closed from the shoulders by means of the fastening unit (1.5).
The third step comprises the following sub-steps in one embodiment:
- The electric motor (2.2) is started by means of the switch (2.3) and the electric motor (2.2) starts to receive electrical energy from the battery unit (2.1),
- Electric motor (2.2) converts the electrical energy it receives into rotational motion,
- The rotational motion transfer unit (2.4) transfers the rotational motion from the horizontal axis to the vertical axis or vice versa,
- The perforated nut (2.5) starts to rotate by taking the rotational motion from the rotational motion transfer unit (2.4),
- The motion transfer rod (2.6) installed in the hole of the perforated nut (2.5) converts the rotational motion of the perforated nut (2.5) into a push-pull motion,
- The piston (2.7.1) receives the push-pull motion and generates air with this motion,
- The valve (2.7.2) receives the air produced by the piston (2.7.1) and delivers it unidirectionally to the air outlet pipe (2.7.3),
- The air outlet pipe (2.7.3) transfers the air to the inner tube (1.4) in the spinal orthosis (1) through the connecting pipe (3) and inflates the inner tube. The order of these method steps and sub steps is not as specified, and the order may vary according to the situation.
Industrial
Figure imgf000014_0001
The present invention relates to a spinal orthosis mechanism (10) suitable for use in children, adults, and geriatric individuals with spinal deformities (e.g. scoliosis, kyphosis) due to orthopedic, neurological, pediatric, rheumatological diseases, which applies a corrective force to the relevant areas of the user's spine with air pressure, and its operation method, and is applicable to the industry.
The invention is not limited to the above explanations; however, a person skilled in the art can easily present different embodiments of the invention. They must be assessed within the scope of the protection claimed by the claims of the invention.

Claims

1. A spinal orthosis mechanism (10), comprising, for correction of a deformity in more than one spinal region of the wearer at the same time, at least one spinal orthosis (1), including at least one fastening unit (1.5) that allows closure after wearing, at least one positive pressure supply unit (2) that generates a predetermined air pressure so that said spinal orthosis (1) can correct the specified deformity, at least one connection pipe (3) providing the connection between said spinal orthosis (1) and the positive pressure supply unit (2) and transmitting the air pressure generated by the positive pressure supply unit (2) to the spinal orthosis (1), characterized in that it comprises said spinal orthosis (1) comprising at least one wearable material (1.1), at least one first pocket (1.2) in the form of an hourglass of a predetermined size, perpendicular to the ground, above and parallel to the spinal axis, positioned on said wearable material (1.1) and coincident with at least one defective location in the spine on the back of the body, comprising at least one first pressure sensing unit (1.2.1) and at least one inner tube insertion part (1.2.2) that calculates the amount of pressure applied, at least one second pocket (1.3) comprising at least one second pressure sensing unit (1.3.1) and at least one inner tube insertion part
(1.3.2) which calculates the amount of pressure applied, in a predetermined form, at a predetermined distance from the axis to the right and/or left of the axis of the spine, again located on the back of the body, coinciding with at least one defective location on the spine, at least one air release valve (1.4.1), positioned so that when inserted in the first pocket (1.2) and/or the second pocket (1.3) it protrudes from the first inner tube insertion part (1.2.2) and/or the second inner tube insertion part (1.3.2), which can reduce or completely release the compressed air when the amount of pressure is to be reduced or after use, at least one inner tube (1.4) of a predetermined size, smaller than the first pocket
(1.2) and/or the second pocket (1.3), which is interchangeable by sliding within the first pocket (1.2) and/or the second pocket (1.3) and including at least one connection pipe inlet (1.4.2) positioned so that a connection pipe (3) can be connected from the first inner tube insertion part (1.2.2) and/or the second inner tube insertion part (1.3.2), suitable for insertion into the first pocket (1.2) from the first inner tube insertion part (1.2.2) and/or into the second pocket (1.3.2) from the second inner tube insertion part (1.3.2), which can be inflated and deflated by the air pressure generated for each first pocket (1.2) and second pocket (1.3), thus exerting a corrective force on the corresponding part of the spine.
2. A spinal orthosis mechanism (10) according to claim 1, characterized in that it comprises a spinal orthosis (1) containing a first pocket (1.2) and a second pocket (1.3), the part in contact with the body made of Lycra fabric to ensure that the pressure of the inflating inner tube (1.4) is completely channeled to the body, and the outer part made of rigid material to prevent the inner tube (1.4) from bulging from the outside, that is, from being seen from the outside
3. A spinal orthosis mechanism (10) according to claim 2, characterized in that it comprises a spinal orthosis (1) containing a first pocket (1.2) comprising a first pressure sensing unit (1.2.1) positioned in one of the triangular regions of the hourglass-shaped first pocket (1.2), preferably in the above region when worn on the body, and a second pocket (1.3) comprising a second pressure sensing unit (1.3.1) positioned parallel to that edge, next to one of the other edges of the second pocket (1.3) in hexagonal form.
4. A spinal orthosis mechanism (10) according to claim 3, characterized in that it comprises a spinal orthosis (1) comprising six second pockets (1.3) positioned at a predetermined distance from each other and from the spinal axis.
5. A spinal orthosis mechanism (10) according to claim 4, characterized in that it comprises a spinal orthosis (1) comprising a wearable material (1.1) containing a non- stretchable material, which is a Lycra fabric with the ability to stretch in areas in contact with the body in areas where air pressure will act, but a double-layered soft nylon fabric with holes of predetermined fineness, tightly woven in all remaining areas.
6. A spinal orthosis mechanism (10) according to claim 5, characterized in that it comprises a positive pressure supply unit (2) containing at least one battery unit providing electrical energy (2.1), at least one electric motor (2.2) connected to the battery unit (2.1) and converting the electrical energy received from the battery unit (2.1) into rotational motion, at least one switch (2.3) for switching the electric motor (2.2) on and off, at least one rotational motion transfer unit (2.4) that transfers the rotational motion received from the electric motor (2.2) from the horizontal axis to the vertical axis or vice versa, at least one perforated nut (2.5) which starts to rotate by receiving the rotational motion from the rotational motion transfer unit (2.4), at least one motion transfer rod (2.6), which is installed in the bore of the perforated nut (2.5) and converts the rotational motion there into a push-pull motion, at least one piston (2.7.1), which receives the push-pull motion in question and generates air by this motion, at least one valve (2.7.2) providing a one-way outlet of the air received from the piston (2.7.1) and preventing the air from escaping backwards, and at least one air outlet pipe (2.7.3) transferring the air received from said valve (2.7.2) to the inner tube (1.4) of the spinal orthosis (1) via said connection pipe (3), at least one piston container (2.7) that is airtight.
7. A spinal orthosis mechanism (10) according to claim 6, characterized in that it comprises the spinal orthosis (1) containing the inner tube (1.4) positioned in the first pocket (1.2) and/or the second pocket (1.3) in the area where the pressure needs to be applied, i.e. where the pressure is supported according to the type of posture disorder in the body, which is connected to the air outlet pipe (2.7.3) of the positive pressure supply unit (2) by connecting the connection pipe (3) from the connection pipe inlet (1.4.2), so that the air pressed from the positive pressure supply unit (2) exits the air outlet pipe (2.7.3), reaches and inflates through the connection pipe (3).
8. A spinal orthosis mechanism (10) as in claim 7, characterized in that it comprises a spinal orthosis (1) containing at least three fastener units positioned on each shoulder and on the front of the body to allow the spinal orthosis (1) to be worn and closed, so that the spinal orthosis (1) conforms to the size of the body
9. A spinal orthosis mechanism (10) as in claim 8, characterized in that it comprises a spinal orthosis (1) containing a second pocket (1.3) in the form of a hexagon of predetermined size, with two opposite sides of predetermined length shorter than the other sides, and placed with the shorter side facing the spinal axis.
10. A method (100) of operating a spinal orthosis mechanism, characterized in that the user comprises the following steps for operating a spinal orthosis mechanism (10) according to any one of claims 1 to 9 to correct a deformity in more than one spinal region of the user simultaneously:
In the first step, at least one inner tube (1.4) is placed in at least one first pocket
(1.2) and/or at least one second pocket (1.3) by sliding in the pockets when necessary, so that the air discharge valve (1.4.1) and the connection pipe inlet
(1.4.2) are excluded from the first inner tube insertion part (1.2.2) and/or the second inner tube insertion part (1.3.2),
In the second step, the positive pressure supply unit (2) is connected to the connection pipe inlet (1.4.2) of the inner tube (1.4.4) via the connection pipe (3), In the third step, air is pumped into the inner tube (1.4) via the positive pressure supply unit (2) to inflate the inner tube (1.4) positioned in the first pocket (1.2) and/or the second pocket (1.3), depending on the type of posture disorder in the body, i.e. where pressure needs to be applied,
In the fourth step, the compressed air is checked with the first pressure sensing unit (1.2.1) and/or the second pressure sensing unit (1.3.1),
In the fifth step, if the pressure amount is less than a predetermined value, the positive pressure supply unit (2) continues to supply air,
In the sixth step, if the pressure amount is more than a predetermined value, the necessary amount of air is discharged by the air discharge valve (1.4.1),
In the seventh step, the wearable material (1.1) is worn by the user and adjusted and/or closed from the shoulders by means of the fastening unit (1.5).
11. A method (100) of operating a spinal orthosis mechanism according to in claim 10, characterized in that the third step comprises the following sub-steps, - The electric motor (2.2) is started by means of the switch (2.3) and the electric motor (2.2) starts to receive electrical energy from the battery unit (2.1),
- Electric motor (2.2) converts the electrical energy it receives into rotational motion, - The rotational motion transfer unit (2.4) transfers the rotational motion from the horizontal axis to the vertical axis or vice versa,
- The perforated nut (2.5) starts to rotate by taking the rotational motion from the rotational motion transfer unit (2.4),
- The motion transfer rod (2.6) installed in the hole of the perforated nut (2.5) converts the rotational motion of the perforated nut (2.5) into a push-pull motion,
- The piston (2.7.1) receives the push-pull motion and generates air with this motion,
- The valve (2.7.2) receives the air produced by the piston (2.7.1) and delivers it unidirectionally to the air outlet pipe (2.7.3), - The air outlet pipe (2.7.3) transfers the air to the inner tube (1.4) in the spinal orthosis (1) through the connecting pipe (3) and inflates the inner tube.
PCT/TR2024/051593 2023-12-22 2024-12-16 An air-inflated spinal orthosis mechanism and operation method thereof Pending WO2025136322A2 (en)

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CN107137170A (en) * 2017-06-30 2017-09-08 国家康复辅具研究中心 Scoliosis orthopedic device, system and long-distance monitoring method
CN209342139U (en) * 2018-11-26 2019-09-03 昆明医科大学 An orthotic wearing monitoring device
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