Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
  • A61B5/316—Modalities, i.e. specific diagnostic methods
  • A61B5/389—Electromyography [EMG]
  • A61B5/395—Details of stimulation, e.g. nerve stimulation to elicit EMG response
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/3604—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation for correcting spinal deformities, e.g. scoliosis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/372—Arrangements in connection with the implantation of stimulators
  • A61N1/37211—Means for communicating with stimulators
  • A61N1/37235—Aspects of the external programmer
  • A61N1/37247—User interfaces, e.g. input or presentation means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
  • A61B5/0031—Implanted circuitry

Definitions

• the main object of the present invention is a system for the treatment of idiopathic scoliosis characterized by being able to treat deep rotator muscles thanks to electrodes based on the data collected by sensors implanted both subcutaneously in a programmable subcutaneous device .
• AIS adolescent idiopathic scoliosis
• Idiopathic scoliosis has remained unknown for years, however, there is growing evidence that spinal deformation is a musculoskeletal expression of central nervous system disorder.
• Some clinical studies have shown abnormalities in the control of balance and proprioception in patients with scoliosis, compared to other healthy patients of the same age and sex.
• the disorder interferes with the interspinous or deep paraspinal musculature, inducing an imbalance of forces that acts on the different vertebral segments.
• the involvement of interspinous muscles or deep rotators in the imbalance of rotational forces explains the asymmetry in the development of scoliotic curves. This imbalance of forces during the period of growth could lead to the development of a scoliosis, with the rotation of the vertebral bodies towards the convex side, due to the tonic predominance of the rotating muscles of the opposite side.
• the system consists of an implantable pulse generator connected to a stimulation electrode system.
• the device is implanted under the skin and its activity is programmed externally by RF, once implanted. It is not provided that the device incorporates any feedback system based on the detection of electromyographic signals from the patient itself, since three electrodes (two positive and one negative) are described, so the device does not incorporate any sensor system for this purpose. , as it incorporates the system object of the present invention.
• the device defined in the article is prepared to act as a pure stimulator and only at night, being implanted in the twelfth rib. While the device recommended here will be located in an area that does not cause discomfort to the patient in the back subcutaneously or submuscularly. Based on the article cited above, some inventions have been developed aimed at implantable devices for the stimulation of the back muscles in order to treat various ailments, including scoliosis, such as, for example, US patent US4026301.
• the treatment cited in said American patent is based on the fact that the impulses are developed by an RF transmitter during the patient's sleep periods, while in the device described herein it is designed so that the implanted device itself transmits the impulses by means of the stimulators until the paraspinal muscle point, continuously depending on the sensing both day and night.
• the system for the treatment of idiopathic scoliosis is presented, object of the present report, which is characterized by being a minimally invasive system, which is permanently implanted as a muscle simulator for a effective treatment of idiopathic scoliosis.
• the system consists of a programmable subcutaneous device, capable of detecting and stimulating the muscles that play the most predominant role in scoliosis (interspinous or deep paraspinal muscles), thanks to a series of stimulators that together with a plurality of sensors (programmed with a software based on a feedback loop algorithm for fine tuning of automatic stimulation) effectively treat spine deformity.
• Its implantation is a simple procedure, which provides superior comfort for patients, to those obtained thanks to current solutions, while allowing a better treatment against idiopathic scoliosis through the use of a minimally invasive surgical technique with the making of an incision of less than 50 mm in length, approximately.
• the system itself will consist of a plurality of sensors and stimulators, which will be implanted under the skin integrated into a device, which will have the mission, on the one hand, of sensing the side whose muscle tone is correct, and stimulating the pathological side in sensing function, to achieve high efficiency in correcting the tone lost in the most predominant muscle in scoliosis. All this is regulated by software based on an optimal stimulation protocol, taking into account the behavior of the musculoskeletal model implemented, through a multiple feedback input loop, at different levels in the curved spine.
• the system is based on the concept of trying to correct scoliosis through the stimulus generated following a multiple feedback loop input (thanks to a plurality of sensors and stimulators, placed on either side of the spine), which allows the use of a personalized stimulation protocol and applied clinically in the key muscle in scoliosis.
• the word "comprises” and its variants are not intended to exclude other technical characteristics, additives, components or steps.
• other objects, advantages and features of the invention will be derived partly from the description and partly from the practice of the invention.
• the following examples and drawings are provided by way of illustration, and are not intended to be limiting of the present invention.
• the present invention covers all possible combinations of particular and preferred embodiments indicated herein.
• FIG. 1 shows a schematic view of the method of work of the system for the treatment of idiopathic scoliosis, where FIG. 1A shows communication during device programming; FIG. 1 B shows how the signal is acquired by the sensors; FIG. 1 C shows electrostimulation; and FIG. 4D schematically shows communication during system maintenance and control.
• FIG. 2 shows a view of a practical embodiment of the implantable subcutaneous device, as part of the system for the treatment of idiopathic scoliosis. PREFERRED EMBODIMENT OF THE INVENTION
• the system for the treatment of idiopathic scoliosis is characterized in that it comprises a programmable subcutaneous device (1) that works in a maximum sensing range of ⁇ 5 mV, consisting essentially of a housing (1 a).
• Attached to said device (1) are a plurality of sensors (2) for recording electromyographic signals; and a variety of stimulators (3) responsible for stimulating the pathological part of the deep paraspinal musculature; both connected by wiring (5) to said subcutaneous device (1).
• the muscle stimulation through the stimulators (3), is controlled by a control software based on a feedback loop algorithm for the adjustment of the stimulation based on the results obtained from the sensors (2), according to a musculoskeletal model, in order to generate a suitable stimulus approximately within 5 * 10 "1 seconds from the acquisition of the electromyographic signals.
• a control software based on a feedback loop algorithm for the adjustment of the stimulation based on the results obtained from the sensors (2), according to a musculoskeletal model, in order to generate a suitable stimulus approximately within 5 * 10 "1 seconds from the acquisition of the electromyographic signals.
• a small energy source according to the system power requirements (minimum control circuit voltage: 2.2 V, pulse range from 15 to 40 J).
• an external console (4) designed on the basis of RFID operation or other wireless data transmission system and whose function is to program the subcutaneous device (1) and collect the patient's bioelectrical data.
• the RFID tag which works in 125 kHz ranges
• the external console (4) will always be in charge of the doctors in charge of supervising the treatment and will be accessible through a completely intuitive user interface.
• the sensors (2) are configured to be able to measure the responses between 20 Hz and 5 kHz, with an amplifier sensitivity of 50 ⁇ , and with a scan duration of approximately 10 ms.
• the stimulators (3) are configured to provide the adjustable pulse force for the stimulation of the paravertebral deep rotator muscles, with a variable stimulus of 1 to 50 Hz for 1 s, and an adjustable intensity between 0.2 and 50 mA, for a single phase stimulation pulse.
• Both the number of sensors (2) and stimulators (3) will vary depending on the levels of spine affected by the pathology of idiopathic scoliosis.
• the device (1) will be introduced into the patient through the use of minimally invasive surgery for implantation of the subcutaneous device in the anatomical location through a skin incision of less than 50 mm in length and for the connection of the electrodes to the key muscles through incisions less than 5 mm in diameter.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• General Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Biomedical Technology (AREA)
• Public Health (AREA)
• Animal Behavior & Ethology (AREA)
• Radiology & Medical Imaging (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Medical Informatics (AREA)
• Physics & Mathematics (AREA)
• Biophysics (AREA)
• Pathology (AREA)
• Heart & Thoracic Surgery (AREA)
• Molecular Biology (AREA)
• Surgery (AREA)
• Physical Education & Sports Medicine (AREA)
• Neurology (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Human Computer Interaction (AREA)
• Electrotherapy Devices (AREA)

Priority Applications (6)

Applications Claiming Priority (2)

Publications (1)

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Citations (5)

Family Cites Families (5)

• 2012
  • 2012-01-24 ES ES201230093A patent/ES2421055B1/es active Active
• 2013
  • 2013-01-11 JP JP2014553770A patent/JP6005178B2/ja not_active Expired - Fee Related
  • 2013-01-11 EP EP13740736.7A patent/EP2808055A4/en not_active Withdrawn
  • 2013-01-11 AU AU2013213494A patent/AU2013213494A1/en not_active Abandoned
  • 2013-01-11 CA CA2862547A patent/CA2862547A1/en not_active Abandoned
  • 2013-01-11 US US14/373,834 patent/US20150032185A1/en not_active Abandoned
  • 2013-01-11 HK HK15100685.3A patent/HK1200131A1/en unknown
  • 2013-01-11 WO PCT/ES2013/070004 patent/WO2013110835A1/es not_active Ceased

Patent Citations (5)

Non-Patent Citations (1)

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