SPINAL CORD STIMULATION SYSTEM

Abstract

The present invention refers to a spinal cord stimulation system for spinal cord stimulation (SCS) which comprises: a) An electrode (1), consisting essentially of a plurality of poles (2), configured to be inserted inside the intradural space (3) through the dura mater (4) via needle-puncture (5) of the skin; b) an unit (6), connected to the electrode, suitable for generating electric current and reading the impedance; and c) a computer comprising a processing unit (10).

Claims

1. Spinal cord stimulation system characterized by comprising: a. An electrode (1) with a diameter ≤1.3 mm, consisting essentially of a plurality of poles (2), suitable for being inserted inside the intradural space (3); b. Unit (6), connected to the electrode, configured to systematically read the impedance of the poles (2) when the electrode (1) is going through the dura matter (4), and to generate electric current; and. c. A computer comprising a processing unit (10) configured to: i. Receive, from the unit (6), continuous impedance readings of each pole when the electrode (1) is going through the dura matter (4), ii. Process the impedance readings received for finding a statistically significant variation or deviation of the impedance, and iii. Provide an output through a terminal, and/or give introductions to unit (6) to apply electric current, when a statistically significant reduction of the impedance of a specific pole (2) is identified, which indicates that the pole (2) has gone through the dura mater (4) and is placed in the intradural space at the inner part of the dura mater-arachnoid (8), wherein the electrical current is to be applied.

2. Spinal cord stimulation system, according to claim 1, further comprising an external fixation to the tissue (9) to fasten the electrode (1) once the pole is placed in the intradural space at the inner part of the dura mater-arachnoid (8), wherein the electrical current is to be applied.

3. Spinal cord stimulation system, according to any of the previous claims, wherein the processing unit (10) comprises at least a computer program comprising instructions to receive, from the unit (6), continuous impedance readings of each pole, process the impedance readings received for finding a statistically significant variation or deviation of the impedance, and provide an output through a terminal, and/or give introductions to unit (6) to apply electric current, when a statistically significant reduction of the impedance is identified.

4. Spinal cord stimulation system, according to any of the previous claims, wherein the electrode (1) with a diameter ≤1.3 mm, consisting essentially of a plurality of poles (2), is configured to be inserted inside the intradural space (3) through the dura mater (4) via needle-puncture (5) of the skin.

5. Spinal cord stimulation system, according any of the previous claims, wherein the electrode (1) has a diameter from 0.15 mm to 0.9 mm.

6. Spinal cord stimulation system, according any of the previous claims, wherein the electrode (1) is flexible in order to easily move throughout the intradural space to the desired metameric level for stimulation and avoid damages in the area.

7. Spinal cord stimulation system, according any of the previous claims, wherein the electrode (1) is covered with a cover (7) that prevents trauma, for example silicone rubber elastomer.

8. Spinal cord stimulation system, according to any of the previous claims, wherein the diameter of the needle (5) is ≤1.31 mm, preferably ≤0.91 mm.

9. Spinal cord stimulation system, according to any of the previous claims, wherein each pole can be programmed to be active or passive.

10. Computer implemented method for assessing whether an electrode pole (2) has gone through the dura mater (4) and it is placed in the intradural space at the inner part of the dura mater-arachnoid (8) which comprises: a) Systematically reading the impedance when the electrode (1) is going through the dura mater (4), and b) wherein the identification of a statistically significant reduction of the impedance of a specific pole (2) indicates that the pole has gone through the dura mater (4) and is placed in the intradural space at the inner part of the dura mater-arachnoid (8), wherein the electrical current is to be applied.

11. A computer program comprising instructions to cause the stimulation system of claims 1 to 9 to execute the steps of the methods of claim 10.

12. A computer-readable medium having stored thereon the computer program of claim 11.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0060] FIG. 1. It shows the electrode of the invention (1), which comprises a plurality of poles (2), and a cover (7).

[0061] FIG. 2. Is shows a sagittal plane illustrating the diameter of the electrode which is ≤1.3 mm, preferably between 0.15 mm to 0.9 mm, in order to be inserted inside the intradural space. The electrode cover (7) is also represented in this figure.

[0062] FIG. 3. It shows the electrode of the invention (1) inserted in the intradural space (3), (and not just in the epidural space), through the dura mater (4), preferably by means of a needle (5) which has a dimeter ≤1.31 mm. It is represented the position where the pole is placed in the intradural space at the inner part of the dura mater-arachnoid (8), wherein the electrical current is to be applied. The computer comprising a processing unit (10) is also represented.

[0063] FIG. 4. It shows a close view wherein a crucial aspect of the invention is illustrated. The electrode of the invention (1) inserted in the intradural space (3), (and not just in the epidural space), through the dura mater (4) and the pole is in the intradural space at the inner part of the dura mater-arachnoid (8), wherein the electrical current is to be applied.