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WO2018220505A1 - Orthothèse de tronc active et son procédé de production - Google Patents

Orthothèse de tronc active et son procédé de production Download PDF

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Publication number
WO2018220505A1
WO2018220505A1 PCT/IB2018/053771 IB2018053771W WO2018220505A1 WO 2018220505 A1 WO2018220505 A1 WO 2018220505A1 IB 2018053771 W IB2018053771 W IB 2018053771W WO 2018220505 A1 WO2018220505 A1 WO 2018220505A1
Authority
WO
WIPO (PCT)
Prior art keywords
orthosis
pressure
trunk
trunk orthosis
pads
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.)
Ceased
Application number
PCT/IB2018/053771
Other languages
English (en)
Portuguese (pt)
Other versions
WO2018220505A4 (fr
Inventor
João Guerreiro
Mariana MAIA
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.)
Universidade do Algarve
Original Assignee
Universidade do Algarve
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
Application filed by Universidade do Algarve filed Critical Universidade do Algarve
Publication of WO2018220505A1 publication Critical patent/WO2018220505A1/fr
Publication of WO2018220505A4 publication Critical patent/WO2018220505A4/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/02—Orthopaedic corsets
    • 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
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/02—Orthopaedic corsets
    • A61F5/024—Orthopaedic corsets having pressure pads connected in a frame for reduction or correction of the curvature of the spine
    • 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
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/02—Orthopaedic corsets
    • A61F5/026—Back straightening devices with shoulder braces to force back the shoulder to obtain a correct curvature of the spine
    • 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
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/02—Orthopaedic corsets
    • A61F5/028—Braces for providing support to the lower back, e.g. lumbo sacral supports

Definitions

  • the present invention relates to a trunk orthosis comprising a rigid external structure with a pneumatic circuit which comprises a set of pressure sensors coupled to pneumatic pads, allowing the pressure exerted on the user's body to be made of gradually, actively and automatically.
  • This device can be used not only to promote support and immobilization of your wearer's spine but also for bedridden patients who can use it even for long periods due to the active pressure adjustment which promotes maintenance of the regular breathing cycle.
  • the present invention relates to the process of obtaining the active trunk orthosis.
  • the present invention falls within the technical field of orthoses, in particular trunk orthoses.
  • Palliative care seeks to improve the lives of patients and their families in the face of disease-related problems. end-of-life prevention through the prevention and alleviation of suffering through early identification, assessment and treatment of pain, physical, psychosocial and spiritual problems.
  • Cancer disease has a usually progressive course leading to a deterioration of the patient's condition which may lead to bone metastases and represent a highly prevalent complication of cancer with significant functional impact.
  • the spine is the site that suffers the most from metastases, as it can cause pain or metastatic compression of the spinal cord.
  • the trunk orthosis can be defined as an external device made of thermoplastic, with corrective forces applied to the trunk that allows to prevent progression, correct pathological lesions and prevent their collapse. Its design varies according to the pathology, but in most cases it has a simple, discrete, lightweight structure and is capable of correcting extension and elongation reflex deformations.
  • Trunk orthoses are mostly used in cases of idiopathic scoliosis for periods of 23 hours / day or 8 hours / day, presenting stable results and good adherence in the first months. However, constant difficulty in adhering and maintaining use for the recommended time periods is indicated due to discomfort caused by the rigid structure of the orthosis.
  • WO2005 / 122725 A2 discloses sagittal-coronally controlled thoracolumbosacral orthoses comprising two rigid plastic outer casings, an anterior casing and a posterior casing, which may comprise pressure pads, which are in contact with the patient's body. and can be customized, these pads are removable and air-inflated for support and stability.
  • US2016278964 A1 describes a stem orthosis comprising inflatable pads with check valves so that the pressure of these pads can be controlled by connecting the valve to a fluid supply source.
  • the pressure control exerted by the pads is not carried out with the necessary rigor, nor is there any possibility of gradual adjustment. Also this orthosis is not suitable for use in bedridden patients.
  • trunk orthoses such as the ones above, present the principles of promoting correct posture, balance of forces and action. creep and cage effect, without allowing a gradual regulation of orthosis pressure, which leads to factors that limit the use of trunk orthoses and which may lead to possible abandonment of the use of the device.
  • trunk orthoses Most of the limitations found with the use of trunk orthoses are associated with the number of hours the patient uses orthoses and the pressure performed by the devices.
  • the device of the present invention solves the problems cited and present in the prior art through a proposal of trunk orthotesis, with a pneumatic circuit that integrates a set of pneumatic pads and pressure sensors, which allows the pressure distribution between the regions. the anterior, posterior and lateral aspects of the body in a gradual, active and rigorous manner, providing its user with the common benefits of using a trunk orthosis, but still comfortable to use even after long periods of use.
  • Fig. 1 shows a schematic of the trunk orthosis according to the present invention in which:
  • (A) refers to the outer frame plates: A1 and A2 refer respectively to the front and rear plate and A3 and A4 to each side plate; (X) refers to pressure sensors: XI and X2 refer respectively to sensors controlling pads 11 and 14 and X3 and X4 to sensors controlling pads 12 and 13.
  • Fig. 2 shows a schematic of the pneumatic circuit B according to the present invention, wherein the reference numerals represent:
  • (B) refers to the pneumatic circuit which comprises:
  • 1 - Represents a compressor powered by 12 volt current
  • the present invention relates to an active trunk orthosis and method for obtaining it.
  • the active torso orthosis comprises a rigid external structure (A) of thermoplastic material comprising four plates (A1 to A4) surrounding the anterior (Al), posterior (A2) and lateral (A3 and A4) regions of the body and which are joined by four thermoplastic bands (Fig. 1).
  • a pneumatic circuit which comprises a set of pads (11 to 14), one for each plate (A) that makes up the orthosis, and sensor systems (XI to X4). ), with a first set of air inlet control valves (3 to 6), and a second set of air valves (7 to 10) responsible for controlling the air outlet of the respective air cushion (11 to 14).
  • the pneumatic pads 11 to 14 are preferably of waterproof, hypoallergenic material and resistant to pressure variations.
  • Sensors are devices that receive a signal and reciprocate with an electrical signal. Sensors are distinguished in assets, which directly generate an electrical signal in response to an external stimulus, and passive, which require an external power supply and / or an excitation signal.
  • a set of sensors (XI to X4) coupled to each of the pneumatic pads (11 to 14) which, when actuated, cause the pressure exerted on the user's body to be actively activated and thus be used to promote not only immobilization of the user's spine, but more importantly, the expansion of the rib cage through a slight deflation of the air cushion and vice versa, thereby maintaining normal breathing cycles.
  • pressure sensors should be placed between the rigid orthosis structure and the pneumatic pads to reduce the risk of pain, wounds or pressure ulcers, and the likelihood of mispositioning and incorrectly sensing forces. decreases .
  • the required pressure that the pressure sensors must measure when inflating the air cushions to the contact between the body surface and the air cushions, with no external load applied, is approximately 10 kPa to overcome volume changes due to edema and involuntary movements such as breathing.
  • Preferred pressure sensors are piezoresistive type and embedded in a fabric covering the semi-flexible structure.
  • the pneumatic pads allow adjustment of the patient's body surface, changing the initial pressure, stimulating the forces / tensions and providing high comfort and mobility of the spine to those who use it.
  • pressure sensors (X) have good results in the analysis of trunk areas most prone to pressure in the various bed positions.
  • Pressure can be observed through a pressure gauge (not shown in the figures) for each of the pads. Pressure is individually selected and preset for each pad via an automatic pressure controller (not shown in the figures). When a certain pressure is selected for each pad, the respective sensor (x) sends information to the electronic system (partially shown in the figures) of circuit (B), so that the adjustment can be made automatically, whether that pressure is involuntarily changed.
  • Circuit diagram (B) presents, in a first phase, 3 T-leads (2), which serve to create a parallel circuit and allow the compressor (1) to distribute air to the four portions of the orthosis. More specifically, said circuit (B) initially has 3 T-leads (2), two of which are connected to the air inlet solenoid valves (3 to 6).
  • circuit (B) has 4 further bypasses (2), one from each air inlet solenoid valve (3 to 6), each terminating in a single solenoid solenoid valve. air inlet and outlet control (7-10) in the respective pneumatic pad (11-14).
  • Pressure sensors are adjusted to maintain an average pressure in the circuit according to medical indication or user characteristics.
  • valves When the pressure detected in one of the sensors is above recommended, the valves (3, 4, 5 or 6) will open, depending on the respective sensor / valve (front, back, left side, right side).
  • valves When pressure at (11, 12,13 and / or 14) detected by the sensors is reached, the valves (3, 4, 5 and / or 6) close.
  • valves (7, 8, 9 or 10) When the pressure detected in one of the sensors is below the recommended, open the valves (7, 8, 9 or 10), depending on the respective sensor / valve (front, back, left side, right side).
  • the pneumatic circuit (B) may comprise a portable, 12-volt, battery-powered compressor (1) promoting the portability of the trunk orthosis of the present invention, and / or comprising a battery-powered compressor (1) mains electricity, thus allowing the compressor (1) to operate for a limited time even if mains electricity failure occurs.
  • the sensors are adjusted to maintain an average pressure in the circuit according to medical indication or user characteristics.
  • valves When the pressure detected in one of the sensors is higher than recommended, the valves (3, 4, 5 or 6) automatically open according to the respective sensor / valve (front, back, left side, right side), thanks to the information provided by the pressure sensors.
  • Each cushion should vary its pressure between 2KPa and 12 KPa.
  • a stop warning signal is activated.
  • the solenoid valves (3, 4, 5 and / or 6) close.
  • valves (7, 8, 9 or 10) open according to the respective sensor / valve (front, back, left side, right side).
  • a visual alarm system is also foreseen through the application of LED and audible alarm. These alarm systems are activated whenever there is a power outage resulting in loss of system functions (color 1), faulty system shutdown (color 2), overpressure detected in sensors (color 2), cushion pressure and current surge prevention (color 2). If excess pressure in the pads is detected, a compressor stop signal is given, all solenoid valves open and the system shuts down.
  • the outer structure (A) of the orthosis is made of a rigid, plastic material, preferably a thermoplastic material.
  • Suitable thermoplastic materials are, for example, polypropylene and low density polyethylene, or combinations of both, which allows for a flexible and adjustable structure.
  • polypropylene and low density polyethylene or combinations of both, which allows for a flexible and adjustable structure.
  • polypropylene and given its characteristics it allows to apply corrective forces, while the low density polyethylene makes it easier to place the device on the user due to its flexibility.
  • the limits of the design of the active device being below the anthropometric values, also facilitate the movements that users perform voluntarily or involuntarily, without preventing a correct stabilization of the pelvic girdle, such as breathing, peristaltic and other movements, which when Difficulty may cause difficulty breathing, digestion, urinary and fecal retention, and cardiac malaise.
  • the active trunk orthosis comprises a rigid external structure (A), a pneumatic circuit (B) comprising a set of sensors (X) coupled to pneumatic pads (11-14), and a compressor ( 1).
  • the production process of this orthosis comprises negative mold drawing, positive mold correction and thermoforming to obtain the final device.
  • anthropometric measurements according to the user's dimensions are used. Plaster bandages are then used to delimit the regions of interest and allow to dry to give the negative cast. After drying, the negative mold is cut through pre-demarcated auxiliary lines so that it can be removed from the subject and closed with plaster bandages.
  • the roughness of the mold should be removed and roughened in the abdominal area so that a suspension zone can be exerted on the trunk orthosis and the iliac groove region.
  • pressure-relieving plaster is placed in the regions of the iliac crest, great trochanter and in the posterior region of the mold to create a plane of symmetry.
  • the mold is smoothed, for example, with a water network to eliminate any roughness and a wet plaster bandage layer is applied to the entire mold.
  • thermoplastic material preferably polypropylene
  • the side plates are bonded with thermoplastic material, preferably with low density polyethylene, along the length of the orthosis.
  • the mold is roughened by the design boundary to remove excess material and round the edges of the trunk orthosis to obtain the external structure of the trunk orthosis.
  • the pressure electrodes preferably piezoresistive type, are embedded in a fabric covering the outer frame and finally the pneumatic pad, and the pressure sensors must be placed between the rigid orthosis frame and the pneumatic pads to decrease the risk of pain, wounds or pressure sores, and the likelihood of being misplaced and incorrectly detecting forces decreases, as noted above.
  • Pubic symphysis, anterosuperior iliac spine, posterosuperior iliac spine, iliac crest, iliac grooves, great trochanter, subclavicular fossa, xiphoid appendage, lower angle of shoulder blade, coccyx, and C7 cervical vertebra were marked.
  • anthropometric measurements Tables 1 and 2).
  • the molding was performed according to common orthoprotective practices and five bandages were unrolled around the user's body sequentially from the anterior and posterior region. From the most prominent area of the buttocks to the axillary area. Strips were cut into the plaster bandages and placed in the shoulder area to cover the subclavicular fossa. Horizontal and downward pressure was exerted above the iliac crests to delimit the region. The negative mold was allowed to dry and, with the aid of a dermatographic pencil, was demarcated in the area of the metal bar and in the shoulder area.
  • the negative mold was cut into these auxiliary cutting lines in order to remove it from the participant.
  • the mold was removed from the subject and closed with plaster bandages.
  • the existing roughness in the mold was removed and about 2 CM was thinned in the abdominal area, in order to exert a suspension zone in the trunk orthosis and in the iliac groove region.
  • Pressure relief plaster was placed in the regions of the iliac crest, great trochanter and in the posterior part of the mold to create a plane of symmetry.
  • the mold was smoothed with sandpaper to remove any roughness and a wet plaster bandage layer was applied over the entire mold.
  • a pneumatic circuit is coupled to the trunk orthosis which is powered by a 12 volt compressor.
  • the system has four branches that end in a solenoid valve. After each of the solenoid valves there is a branch of the circuit for a pad and a second solenoid valve.
  • the pads are applied to the anterior, lateral and posterior part of the trunk orthosis, thus obtaining a personalized active trunk orthosis, which allows the pressure distribution between the anterior, posterior and lateral regions of the body, thus conferring comfort to its user beyond its primary function.
  • an active stem orthosis comprising a rigid external support structure composed of 4 pieces of 5MM polypropylene, connected by low density polyethylene, according to the dimensions shown in Table 3 below:
  • the two lateral pieces have been designed with progressively increasing width to ensure pressure in the iliac grooves, and the length is intended to slightly relieve the axillary and hip region.
  • the anterior part covers the xiphoid appendage and slightly above the upper edge of the pubic symphysis, and is designed to progressively increase the width from the xiphoid appendage region to above the upper edge of the pubic symphysis.
  • the rear part has larger dimensions than the front part to promote the bowl backwards. Its width has also been designed to progressively increase from the shoulder blades to above the gluteal region.
  • the structure is also composed of 4 flexible 3MM low density polyethylene (PELD) pieces, with 7CM width and 45 CM length.
  • PELD low density polyethylene
  • these pieces were drilled holes with a distance of 3CM from the margin and 5CM between each hole, and were riveted between the side and back pieces, the excess material was chopped so as to face the rigid structure.
  • the remaining 2 flexible pieces were riveted to the previous one only.
  • two holes were drilled on each side of the rigid structure, both at 5CM but side margins of the part, the closest to the upper edge of the pubic symphysis 5CM from the lower margin and the other 15CM from it.
  • In the anterior piece was riveted velcro, and in the set of lateral and posterior parts was riveted, with skin, the buckle.
  • Bedridden patients are in the same position for a long time, changing the position between the dorsal, right lateral and left lateral positions over the hours. As such, as the decubitus will occur, greater pressure will occur on the posterior region of the orthosis or on the sides. In this way, the pressure can be adjusted to the decubitus position up to the limit of 18KPa and the pressure on the remaining pads can be reduced, maintaining a sum of 72KPa on the 4 sensors.
  • the pressure range is regulated by the pressure gauge.

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  • Health & Medical Sciences (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

La présente invention concerne une orthothèse de tronc pouvant être utilisée pour assurer un support et une immobilisation de la colonne vertébrale d'un patient, y compris de patients alités. Le dispositif de la présente invention comprend une structure rigide en plastique pour servir de support au tronc ainsi qu'un circuit pneumatique, intégrant un système électronique avec un ensemble de capteurs de pression et un régulateur de pression, et des coussins pneumatiques permettant de gonfler et de vider graduellement, activement et automatiquement chacun des coussins pneumatiques de manière indépendante, régulant ainsi la pression appliquée à l'orthothèse. Le procédé de mise au point de l'orthothèse de tronc consiste en un tirage de moule négatif, une correction de moule positif et un thermomoulage final du dispositif. Par conséquent, la présente relève du domaine technique des dispositifs orthopédiques, notamment ceux destinés au tronc.
PCT/IB2018/053771 2017-05-29 2018-05-28 Orthothèse de tronc active et son procédé de production Ceased WO2018220505A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PT11011017A PT110110A (pt) 2017-05-29 2017-05-29 Ortótese de tronco activa e processo para a sua produção
PT110110 2017-05-29

Publications (2)

Publication Number Publication Date
WO2018220505A1 true WO2018220505A1 (fr) 2018-12-06
WO2018220505A4 WO2018220505A4 (fr) 2019-02-21

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PCT/IB2018/053771 Ceased WO2018220505A1 (fr) 2017-05-29 2018-05-28 Orthothèse de tronc active et son procédé de production

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PT (1) PT110110A (fr)
WO (1) WO2018220505A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE1029271B1 (fr) * 2022-08-18 2023-08-21 The First Affiliated Hospital Of Jinzhou Medical Univ Une compression par airbag combinée à un appareil orthopédique pour scoliose imprimé en 3D

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110301519A1 (en) * 2010-06-03 2011-12-08 Hon Hai Precision Industry Co., Ltd. Orthopedic adjustment device
US20140039371A1 (en) * 2012-08-02 2014-02-06 The Regents Of The University Of Michigan Active exoskeletal spinal orthosis and method of orthotic treatment
WO2015164814A2 (fr) * 2014-04-25 2015-10-29 The Trustees Of Columbia University In The City Of New York Dispositifs, procédés et systèmes de traitement du rachis

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110301519A1 (en) * 2010-06-03 2011-12-08 Hon Hai Precision Industry Co., Ltd. Orthopedic adjustment device
US20140039371A1 (en) * 2012-08-02 2014-02-06 The Regents Of The University Of Michigan Active exoskeletal spinal orthosis and method of orthotic treatment
WO2015164814A2 (fr) * 2014-04-25 2015-10-29 The Trustees Of Columbia University In The City Of New York Dispositifs, procédés et systèmes de traitement du rachis

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE1029271B1 (fr) * 2022-08-18 2023-08-21 The First Affiliated Hospital Of Jinzhou Medical Univ Une compression par airbag combinée à un appareil orthopédique pour scoliose imprimé en 3D

Also Published As

Publication number Publication date
WO2018220505A4 (fr) 2019-02-21
PT110110A (pt) 2018-11-29

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