RU106841U1 - IMPLANTED DEVICE FOR STIMULATION OF THE SPINAL CORD - Google Patents

Abstract

 1. An implantable device for stimulating the spinal cord, containing a catheter having an output to an electric signal source and an electrode, and a fiber located inside the catheter with a core, an optical, protective sheath, with leads to electromagnetic radiation sources and with optical windows located near the distal end of the fiber occupying an area commensurate with the area of damage to the spinal cord, characterized in that it has a tube located coaxially with the catheter, configured to enter the catheter with about a fiber, longitudinal movement relative to them and having an output to an electric signal source and an electrode, while the optical windows are formed in the form of sections periodically repeating along the fiber that are not occupied by a protective and optical sheath and covered with an optical antireflective coating with the possibility of transmitting electromagnetic radiation of infrared, red, green and blue wavelength range. ! 2. The device according to claim 1, characterized in that the catheter is made relative to the tube protruding to a distance of about 5-15 cm

Description

The utility model relates to medical equipment, in particular to equipment for neurosurgery, and is intended to stimulate recovery processes in the area of damage to the spinal cord using such therapeutic factors as exposure to electric current and low-intensity electromagnetic radiation of the infrared, red, green, and blue wavelength ranges .

Exposure to electric current during electrical stimulation leads to a pronounced analgesic effect, activates the processes of regeneration of nerve tissue. At the same time, the activity of tissue enzymes increases, the metabolism of proteins and nucleic acids is normalized, the conduction function of the spinal cord is restored [Karepov G.V. Exercise therapy and physiotherapy in the system of rehabilitation of patients with traumatic spinal cord disease. - To: Health, 1991. S.10-12]

Exposure to low-intensity electromagnetic radiation in the infrared and visible wavelength ranges is manifested in the stimulation of regenerative and reparative processes of body tissues, the mechanisms of humoral and cellular immunity, the acceleration of healing of wounds and injuries, the increase in the effectiveness of antimicrobial protection and antitumor resistance of the body, the enhancement of vascular neoplasm processes, and the improvement of hemo- and lymphomicrocirculation, rheological properties of blood [Brill G.E., Gasparyan L.V. The mechanisms of therapeutic action of low-intensity laser radiation. Materials of the IV Congress of Photobiologists of Russia. Saratov, 2005. P.14].

It has been objectively established that low-intensity radiation of various wavelengths, that is, different light, has a different effect on the human body. Infrared radiation helps to reduce swelling in the focus of inflammation and enhance metabolic processes in irradiated tissues. Increased blood flow, protein and amino acid metabolism significantly weaken the activity of the inflammatory process and stimulate the proliferation of affected tissues. Red radiation activates catabolic processes and stimulates fibroblasts of connective tissue, which leads to increased reparative regeneration of affected tissues. This effect activates the microcirculation processes and stimulates trophic processes in the tissues, cellular and humoral immunity. Green radiation restores the activity of the sympathoadrenal system inhibited by the pathological process, significantly reduces the intensity of inflammation and autoimmune defects. Blue radiation enhances glycolysis and lipolysis in cells, has an antiseptic effect, and is indicated for use in diseases of the central and peripheral nervous system [Veselovsky A. et al. Development trends, development and research of physiotherapeutic equipment for photochromotherapy. Optical and Laser Technologies: Collection of articles / Ed. V.N. Vasilieva. SPb: SPb GITMO (TU), 2001. S.152-154; Builin V.A., Laryushin A.I., Nikitina M.V. Light laser therapy. A guide for doctors. Moscow, 2004. S.11-31].

A device is known that is used to stimulate the spinal cord, namely, local laser therapy in the surgical treatment of injuries and diseases of the spine [RU patent for invention No. 2289457]. It is a fiber with output to a laser source. Two to four fibers are implanted in the epidural space near the zone of the intended impact, while they are installed and fixed perpendicular to the dural sac. A low-intensity infrared laser with a wavelength of 780 nm and an output power of less than 2 mW is used as a laser source.

A device is also known for stimulating reparative processes in the focal point of spinal cord injury [V.V. Stupak, A.M. Zaydman, N.N. Serpeninova. Morphological substantiation of the use of low-intensity laser radiation in patients with foci of concussion of the spinal cord. Questions of neurosurgery, No. 4, 1998]. It is a polymer tube with a light guide inside, which has an output to a source of electromagnetic laser radiation. For stimulation, the device is conducted to the dura mater at the site of injury and its distal end is installed over the area of damage to the spinal cord. A low-intensity laser with a wavelength of 780 nm or 630 nm and an output power of about 4 mW is used as a laser radiation source.

However, the devices described above allow affecting the area of damage to the spinal cord with only one therapeutic factor - low-intensity optical radiation - and are not intended for complex exposure. In addition, the optical fibers used in the above devices have only one optical window at the distal end, i.e. their designs provide operation by impact from the front side.

Also known are electrical stimulation kits "1x8 standart lead kit" models 3777, 3778 and Pisces-Quad® lead kit models 3487, 3488 from Medtronic [Brochure "ITB Therapy ^SM and Chronic Pain Therapies", 2010, p.8-9]. They are catheter tubes with 4-8 electrodes in the distal part and an appropriate number of leads to the source of electrical signals.

However, these devices are designed to conduct electrical stimulation, and they do not provide structural elements for conducting optical stimulation of the area of damage to the spinal cord. The electrodes are fixedly mounted on the catheter tube, therefore, to stimulate the area of damage to the spinal cord, which has a longitudinal size greater than the distance between adjacent electrodes, it is necessary to reprogram the device for supplying voltage from one of these electrodes to another, which is not adjacent. However, it is not always possible to optimally position the active electrodes directly above and below the damage area.

A device for stimulation is also known [US application No. 2010174329 "Combined optical and electrical neural stimulation))], which is made in the form of a tube with electrodes and optical windows. These elements for stimulation are located near the distal end, occupying an area commensurate with the proposed exposure area. Each of its optical windows is a lens connected to the distal end of the optical fiber brought to the side surface in the form of an optical fiber.

This device is intended for use as a hearing stimulator, which is implanted in the cochlea, and is not intended to stimulate the spinal cord. For the manufacture of each optical window, a separate fiber is required, which significantly increases the diameter of the device, the consumption of materials and cost.

The closest analogue to the claimed utility model is a device for stimulation of the spinal cord [patent EP for invention No. 1502624 "Stimulation catheter with electrode and optical fiber"]. This device is a catheter in which several optical fibers in the form of optical fibers can be installed. The device contains electrodes, optical windows, which are the distal ends of the optical fibers brought to the surface of the device, and leads to sources of electrical signals and electromagnetic radiation.

This device has a drawback similar to Medtronic electrical stimulation kits, as its electrodes are fixedly mounted on the catheter and the optical windows are formed at the end of the device, therefore, when the electrodes are located above and below the spinal cord injury region, the optical windows are higher than the latter and, therefore, do not allow its stimulation using laser optical radiation without changing the position.

The objective of the claimed utility model is the creation of an implantable device for stimulating the spinal cord, which allows both electric current and low-intensity electromagnetic radiation of the infrared, red, green and blue wavelength ranges to affect the spinal cord damage region of any longitudinal size without changing the position of the device itself.

The essence of the claimed utility model lies in the fact that an implantable device for stimulating the spinal cord, containing a catheter having an output to an electric signal source and an electrode, and an optical fiber with a core, an optical, protective sheath, with conclusions to electromagnetic radiation sources and with optical fibers, located inside the catheter windows located near the distal end of the fiber, occupying on it a region commensurate with the area of damage to the spinal cord, has a tube located coaxially with the catheter, made with the possibility of entering into it a catheter with a light guide, longitudinal movement relative to them and having an output to a source of electrical signals and an electrode; the optical windows are formed in the form of sections periodically repeating along the fiber that are not occupied by the protective and optical cladding and covered with an optical antireflective coating with the possibility of transmitting electromagnetic radiation from the infrared, red, green, and blue wavelength ranges. In addition, a utility model with the above features is claimed, in which the catheter is made relative to the tube protruding at a distance of about 5-15 cm.

The technical result of the claimed utility model.

The use of a design feature new for stimulation of the spinal cord, namely, the location of the tube coaxially with the catheter with the optical fiber with the possibility of longitudinal movement relative to them, allows you to change the distance between the electrodes located on these tubes to place them above and below the area of damage to the spinal cord of any longitudinal size.

The formation of optical windows in the form of repeating sections along the fiber, that is, directly on the fiber allows you to use only one fiber, which reduces the diameter of the device and saves expensive consumables. The optical windows formed in this way appear upon implantation of the device directly opposite the area of damage to the spinal cord, which makes it possible to stimulate the nerve structures using low-intensity electromagnetic radiation without changing the position of the device or without installing additional devices. The indicated formation of optical windows is obtained using a mechanism for their manufacture, new for stimulation of the spinal cord. Optical windows are sections of a fiber that are not occupied by the protective and optical shells and are coated with an optical antireflection coating. The formation of optical windows in this way allows efficient dispersion of radiation to affect damage to the spinal cord, as when liberated from the protective and optical cladding, the fiber section begins to emit 10-20% of the radiation passing through it, and the use of the antireflective coating of the optical windows allows this percentage to be increased and it is possible to efficiently isolate the radiation from the infrared, red, green, and blue wavelength ranges, so and each range individually, namely infrared with a wavelength of 750-1300 nm, red with a wavelength of 610-690 nm, green with a wavelength of 510-550 nm and blue with a wavelength of 400-470 nm due to different coating thicknesses and materials a. Design features of the claimed device allow exposure to one of the corresponding sources of electromagnetic radiation or several sources at the same time, using their various combinations and sequences.

The execution of the catheter relative to the tube protruding at a distance of the order of 5-15 cm allows the neurosurgeon to effectively fix it with telescopic extension.

The utility model is illustrated using Fig.1-3, which depict:

- figure 1 is a longitudinal section of an implantable device for stimulation of the spinal cord;

- figure 2 is a transverse section of an implantable device for stimulation of the spinal cord in section AA Figure 1.

- figure 3 is a longitudinal section of a fiber with optical windows. In Fig. 1-3, positions 1-11 indicate:

1 - optical fiber;

2 - catheter;

3 - tube;

4 - core;

5 - optical cladding;

6 - a protective shell;

7 - optical window;

8 - optical antireflection coating;

9 - output to sources of electromagnetic radiation;

10 - output to a source of electrical signals;

11 - electrode.

The implantable device for stimulating the spinal cord contains coaxial cylindrical elongated located in each other in the direction from the central longitudinal axis to the periphery: fiber 1, catheter 2 and tube 3.

An optical fiber with a diameter of 0.1-0.4 mm with a core of 4, optical 5 and protective 6 claddings is used as a fiber. The optical windows 7 are formed in the form of sections periodically repeating along the optical fiber 1 that are not occupied by the optical 5 and protective 6 claddings and are coated with an optical antireflective coating 8 that transmits electromagnetic radiation from the infrared, red, green, and blue wavelength ranges. The most preferred form of the optical window 7 is a ring. The longitudinal size of the optical window 7 is of the order of 3-6 mm. The distance between the windows 7 is about 4-7 mm. The longitudinal size of the optical window 7 and the coating material 8, its thickness is selected so that approximately the same amount of electromagnetic radiation is emitted through each optical window 7. It is possible to fulfill all optical windows 7 of the same type for transmitting radiation of all the above wavelength ranges or to divide them into several types, each of which effectively passes only one specific range of the above. The latter is possible when using an optical antireflection coating 8 of different thicknesses or from various materials. At the distal end of the optical fiber 1, a metal mirror coating is applied by vacuum deposition to reflect electromagnetic radiation from it and increase the efficiency of radiation scattering through optical windows. In addition, the fiber 1 has conclusions on the sources of electromagnetic radiation 9.

Tube 3 and catheter 2 are used predominantly flexible, made of polymers, for example, polyurethane, polyethylene, fluoroplastic. The catheter 2 has an output to the source of electrical signals 10 and the electrode 11. On the tube 3 is also placed 9 on the source of the electrical signals and the electrode 11. The electrodes 11 are usually located at the distal ends of the catheter 2 and tube 3, respectively. The inner diameter of the catheter 2 is about 0.1- 0.4 mm; its outer diameter is 0.6-1.0 mm; the inner diameter of the tube 3 is approximately equal to the outer diameter of the catheter 2; its outer diameter is 0.3-0.5 mm larger than the inner; the length of the catheter 2 is 40-100 cm. The length of the tube 3 can be 5-15 cm shorter. To more accurately change the movement of the catheter 2 relative to the tube 3 and, accordingly, one electrode 11 relative to the other electrode 11, a millimeter scale deposited on the catheter tube can be used.

The above electrodes 11 are made in the form of rings of metallic conductive material, for example, medical steel, titanium, tantalum. Their longitudinal size is about 2-6 mm.

As a source of electrical signals, approved for use in medical practice stimulants, for example, domestic production, are stationary (UEI-1, ENS-01, ESU-2, Delta-102, Eliman-101) and portable (Delta-101, Eliman-206 , Mirabelle, Neuron-02).

As sources of electromagnetic radiation using portable semiconductor lasers or LEDs for the infrared, red, green and blue wavelength ranges. For the simultaneous connection of several sources, it is possible to carry out the corresponding number of pins 9.

The device operates as follows.

Using computed tomography studies, the level of the affected segments of the spinal cord relative to the spinal column and the longitudinal size of the lesion area are determined. Depending on the pathology and surgical treatment performed, the implantable device for stimulating the spinal cord is installed in an open way, for example, by means of microlaminectomy, or with local anesthesia by a puncture method in the epidural space of the spinal canal on the dura mater, while the catheter 2 electrode 11 is positioned above the damage area . After implantation, they begin to change the position of the electrode 11 of the tube 3. The neurosurgeon fixes the catheter 2, namely its proximal end closest to it, and begins to move the tube 3, thus changing the distance between the electrodes 11. The distance by which the tubes must be extended is determined by the longitudinal size damage to the spinal cord, which is determined using computed tomography studies, as described above. The second electrode 11 is located below the area of damage to the spinal cord. The optimal location is determined using test stimulation. After the above implantation, the optical windows 7 are directly above the area of damage to the spinal cord. The device is connected to sources of electrical signals and electromagnetic radiation through the corresponding conclusions 9 and 10.

Depending on the type of pathology and the condition of the patient, the neurosurgeon selects the necessary effect according to the modes and methods known from practice and literature. Any influence can be used as an option, for example, stimulation by electric pulses, electromagnetic radiation from the infrared, red, green and blue wavelength ranges. Perhaps a combination with drug therapy. In the case of positive results of the test period and the need for prolonged from a month to 2-3 years of electrical stimulation, subcutaneous implantation of sources of electrical signals and electromagnetic radiation is performed.

All external devices can be connected to a controller with a microprocessor, a control unit, memory devices and an analog-to-digital converter. Combined types of exposure can be stored as separate control programs in the RAM of the controller.

Example.

Patient L, 25 years old, was admitted to the neurosurgery clinic with a diagnosis of Compression-comminuted fracture of the L1 vertebral body with contusion and compression of the spinal cord with bone fragments. Lower paraparesis, partial dysfunction of the pelvic organs. "

Upon admission to the patient in neurological status, it was noted: impaired sensitivity in the form of hyperesthesia at the level of L2-L3 segments, hyperesthesia from the level of L4 segment, muscle strength in the proximal lower extremities reduced to 2 points, in the distal to 1 point, partial violation of the pelvic functions organs by type of delay. An X-ray examination revealed a compression-comminuted fracture of the vertebral body L1 with a wedge index of 0.4 and an angle of kyphotic deformation of 18.

A CT scan shows a displacement of bone fragments into the lumen of the spinal canal with compression of the dural sac. Deficiency of the lumen of the spinal canal is 60%. An MRI scan shows signs of spinal cord bruises in the area up to 2 cm at the L1 level of the vertebra, impaired cerebrospinal fluid dynamics, spinal cord edema extending above and below the site of spinal cord damage by 3 and 1 cm, respectively. The patient underwent osteoplastic laminectomy of TH12-L1 vertebrae, impaction of bone fragments, correction of spinal deformity and its fixation at the level of TH12-L2 segments by the transpedicular system. During a myelographic study with the introduction of 15 ml of Omnipack contrast agent, the patency of the subarachnoid spaces was restored as a result of surgical intervention, and the deformation of the spinal canal was eliminated. A spinal cord stimulation device was installed epidurally on the surface of the spinal cord in the spinal canal. Then, taking into account the data of an MRI study: the focus of the spinal cord injury is up to 2 cm and the length of its edema is 3 cm higher and 1 cm below the focus, the telescopic tube of the device was 6 cm apart so as to capture areas of edema and contusion in the laser exposure zone spinal cord. A catheter tube with a light guide is removed through an additional puncture of the muscle and skin to the surface and is fixed to the skin 5 cm lateral from the surgical wound. Then, against the background of drug therapy, 12 hours after the operation, the light guide electrode was connected to the electromagnetic radiation generator, and laser stimulation was started on the spinal cord in such a way that electromagnetic radiation of the blue wavelength range was supplied to the spinal cord edema, and to the bruised area - infrared range. The exposure was carried out for 3 minutes with a frequency of 8 hours for 5 days. After this, an MRI scan was performed again, in which a significant decrease in spinal cord edema was noted. Then, to stimulate microcirculation and reparative processes in the spinal cord, from the 6th day, exposure to electromagnetic radiation of the red wavelength range was started with an exposure duration of 3 minutes and a frequency of 8 hours for 7 days, after which the spinal cord was electrostimulated for 10 minutes with a current amplitude 20 μA, frequency 65 Hz, pulse duration 0.3 ms. From the 14th day after the operation, electromagnetic radiation of the red range was replaced by the green range for immunomodulating exposure and was carried out for 10 days. After each laser treatment session, the spinal cord was stimulated with a green wavelength range of 15 minutes. As a result of the electro-laser stimulation effect on the spinal cord when observing the neurological status of the patient, a restoration of the function of the pelvic organs on the 6th day after the start of the stimulation effect, an increase in the muscle strength of the proximal lower extremities to 3 points, and in the distal sections to 1 point. By the end of the course of electro-laser stimulation of the spinal cord, an improvement in sensitivity and an increase in muscle strength in the lower extremities to 3-4 points in the proximal sections and 2-3 points in the distal sections were noted. The patient began to move without external support and was discharged for outpatient treatment. The patient was recommended to undergo a repeated course of electro-laser stimulation after 6 months.

Claims (2)

1. An implantable device for stimulating the spinal cord, containing a catheter having an output to an electric signal source and an electrode, and a fiber located inside the catheter with a core, an optical, protective sheath, with leads to electromagnetic radiation sources and with optical windows located near the distal end of the fiber occupying an area commensurate with the area of damage to the spinal cord, characterized in that it has a tube located coaxially with the catheter, configured to enter the catheter with about a fiber, longitudinal movement relative to them and having an output to an electric signal source and an electrode, while the optical windows are formed in the form of sections periodically repeating along the fiber that are not occupied by a protective and optical sheath and covered with an optical antireflective coating with the possibility of transmitting electromagnetic radiation of infrared, red, green and blue wavelength range. 2. The device according to claim 1, characterized in that the catheter is made relative to the tube protruding to a distance of about 5-15 cm