NERVE STIMULATION DEVICE

Description

[0001] The invention relates to a device for nerve stimulation.

[0002] It is known that electrical current pulses, such as low-frequency alternating current, are used to deliver low-voltage pulses to the skin via electrodes placed on the skin to stimulate the nerves transcutaneously. However, the skin presents a comparatively high contact resistance. Furthermore, the stimulation is usually applied over a large area.

[0003] Devices for nerve stimulation are known, for example, from WO 97 / 15347 A1, US 2011 / 054383 A1, US 2008 / 114432 A1 and US 4,824,433 A. DE 298 20 525 U1 discloses a device for nerve stimulation with the features of the preamble of claim 1.

[0004] It is therefore an object of the invention to provide an improved device for nerve stimulation, which is particularly versatile and with which more direct stimulation is preferably possible.

[0005] The object of the invention is solved by a device for nerve stimulation with the features of claim 1.

[0006] Advantageous embodiments and further developments of the invention are specified in the dependent claims.

[0007] The nerve stimulation device according to the invention comprises an electrically conductive stimulation wire with a diameter, a distal end and a proximal end, which is arranged in an electrically insulating tube with an inner diameter, an outer diameter, a distal end and a proximal end, wherein the inner diameter of the tube is larger than the diameter of the stimulation wire, so that a gap for supplying fluid into the tube is formed, wherein a stimulation electrode is arranged in an electrically conductive manner at the distal end of the stimulation wire, which projects beyond the distal end of the tube, and wherein the proximal end of the stimulation wire projects beyond the proximal end of the tube and is bent around the proximal end of the tube to the outside of the tube.wherein an electrically conductive stimulation cable is electrically connected to the proximal end of the stimulation wire and wherein an injection hose is sectionally and sealingly fitted over the proximal end of the hose.

[0008] The device according to the invention is suitable for both nerve stimulation and the administration of a fluid, for example, a liquid such as an anesthetic. Because the stimulation wire is arranged within the lumen of the tube, the invention results in a particularly compact design. The stimulation wire, bent at the proximal end of the tube, allows for easy connection of the stimulation cable to the outside of the tube without having to guide the stimulation wire through the tube wall, thus avoiding a potential leak point.

[0009] Due to the flexibility of the tube, a long, flexible device can be provided that can be inserted into the body either through cannulas or indwelling catheters, or through a natural body opening, such as the nose, bladder, or vagina, without the need for an incision. This allows for stimulation of nerves that are difficult or impossible to access using stimulation electrodes attached to the skin externally.

[0010] According to an advantageous embodiment of the invention, the stimulation electrode has a rounded outer surface and is, for example, dome-shaped, spherical, ellipsoidal, mushroom-shaped, pear-shaped, or egg-shaped. The rounded shape helps prevent injuries to the body of the person being treated. Furthermore, this design of the stimulation electrode can simplify the insertion of the device, particularly into the body orifice.

[0011] A preferred embodiment of the invention provides that the stimulation electrode has an outer diameter, at least in one cross-section, that is larger than the outer diameter of the tubing. In other words, at least the largest outer diameter of the stimulation electrode is larger than the outer diameter of the tubing. This design provides the largest possible surface area of ​​the stimulation electrode, which can improve its stimulation performance.

[0012] It is conceivable that fluid could leak from the distal end of the tubing between the stimulation electrode and the tubing wall. Advantageously, the stimulation electrode is positively integrated with a mounting section in the distal end of the tubing, with the tubing wall having at least one injection port opening into the gap between the stimulation wire and the tubing, and / or the stimulation electrode having an axial through-hole. This positive-locking arrangement stabilizes the distal end of the stimulation wire within the tubing. Furthermore, the positive-locking arrangement can seal the distal end of the tubing to prevent particles from entering or clogging it.In this embodiment, the fluid can exit laterally through the at least one injection opening arranged in the wall of the hose and / or through the axial through-opening of the stimulation electrode.

[0013] Preferably, the proximal end of the tube, including the connection points to the stimulation cable and the injection tube, is arranged in a housing, with the stimulation cable and the injection tube exiting the housing proximally, particularly parallel to the longitudinal axis of the tube. The proximal end of the tube, including the connections, can be inserted into the housing and additionally encapsulated with an adhesive or overmolded with a housing. In this way, the connections can be protected.

[0014] The diameter of the stimulation wire is preferably less than 0.3 mm, preferably about 0.2 mm. This allows for a thin, flexible stimulation wire that can be easily inserted into the body, particularly into natural body orifices.

[0015] Preferably, the stimulation wire is made of stainless steel. This ensures the necessary stability of the stimulation wire, especially at lengths exceeding 10 cm.

[0016] According to a particularly preferred embodiment of the invention, the outer diameter of the tube is less than 1.0 mm, preferably less than 0.9 mm. This allows for a dimensioning of the nerve stimulation device that enables easy insertion into the body, particularly into natural body orifices.

[0017] Preferably, the inner diameter of the tube is in the range of 0.4 mm to 0.7 mm, preferably in the range of 0.5 mm to 0.6 mm. Such dimensions allow a sufficiently large gap between the inner wall of the tube and the stimulation wire to allow fluid to flow through the tube from the proximal to the distal end.

[0018] According to a preferred embodiment of the invention, the length of the tube is more than 10 cm, preferably more than 15 cm, and particularly preferably more than 20 cm, for example 32.2 cm. This provides sufficient length to allow the nerve stimulation device to be inserted far enough into the body, for example into natural body orifices.

[0019] A preferred embodiment of the invention provides that the hose is made of plastic, for example a polyamide. Such a material can offer sufficient tightness, high flexibility, and good biocompatibility.

[0020] Preferably, the tube has markings starting from the distal end, which can visualize to a user the length by which the tube has already been inserted into the body.

[0021] A device according to the invention is used for nerve stimulation through a natural body opening, for example the nose, bladder, or vagina. For example, when inserted through the nose, nerve stimulation of the sphenopalatine ganglion can be performed, or when an anesthetic is injected, a blockade of the sphenopalatine ganglion can be performed, for example, to treat facial and headaches in migraine.

[0022] An embodiment of the invention is explained in detail with reference to the following figures. They show Fig. 1 a side view of an embodiment of a device according to the invention for nerve stimulation, Fig. 2 a detailed view of the distal end of the device according to Fig. 1 , Fig. 3 a longitudinal section of the distal end according to Fig. 2 , Fig. 4 a partially cutaway view of the device according to Fig. 1 and Fig. 5 a detail enlargement from Fig. 4 .

[0023] The Figures 1 to 5 The figures show various views of an embodiment of a device 10 for nerve stimulation. For clarity, not all reference numerals are shown in all figures.

[0024] The device 10 comprises an electrically conductive stimulation wire 20 with a diameter AD, a distal end 20a, and a proximal end 20b. The stimulation wire 20 is, in particular, a flexible, bendable wire. The stimulation wire 20 is, for example, made of stainless steel. The diameter AD of the stimulation wire 20 can be less than 0.3 mm, preferably about 0.2 mm.

[0025] The device 10 further comprises an electrically insulating tube 40 with an inner diameter IS, an outer diameter AS, a distal end 40a, and a proximal end 40b. The tube 40 is, in particular, a flexible, leak-proof, and biocompatible tube. The tube 40 can, for example, be made of plastic, preferably a polyamide. The outer diameter AS of the tube 40 is preferably less than 1.0 mm, particularly preferably less than 0.9 mm, and can, for example, be 0.87 mm. The inner diameter IS of the tube 40 is larger than the diameter AD of the stimulation wire 20 and can be in the range of 0.4 mm to 0.7 mm, preferably in the range of 0.5 mm to 0.6 mm, and can, for example, be 0.54 mm. The length L of the tube 40 is more than 10 cm, preferably more than 15 cm, particularly preferably more than 20 cm, for example, 32.2 cm.Starting from the distal end 40a, the tube 40 can have markings 44 (see . Figs. 1 and 4 ), which are in particular arranged equidistantly and can give the user information about the length by which the distal end 40a of the tube 40 has been inserted into a body.

[0026] The stimulation wire 20 is arranged in the tube 40, in particular guided through the lumen of the tube 40. Because the inner diameter IS of the tube 40 is larger than the diameter AD of the stimulation wire 20, a gap 46 is formed in the tube 40, in particular an annular gap between the stimulation wire 20 and the inner wall of the tube 40, through which fluid can be guided from the proximal end 40b of the tube 40 to the distal end 40a of the tube 40, as described in more detail below.

[0027] A stimulation electrode 30 is electrically conductively arranged at the distal end 20a of the stimulation wire 20 and projects beyond the distal end 40a of the tube 40. The stimulation electrode 30 can have a rounded outer surface 32 and may be, for example, dome-shaped, spherical, ellipsoidal, mushroom-shaped, pear-shaped, egg-shaped, or otherwise convex. Due to the convex shape of the stimulation electrode 30, it has a maximum outer diameter AE in at least one cross-section. This outer diameter AE of the stimulation electrode 30 is larger than the outer diameter AS of the tube 40 (see in particular [reference]). Figs. 2 and 3 ).

[0028] The electrically conductive connection between the stimulation wire 20 and the stimulation electrode 30 can be formed, for example, by inserting the distal end 20a of the stimulation wire 20 into a blind hole 38 arranged in the stimulation electrode 30 or in a fastening section 34 arranged on the stimulation electrode 30 and fixing it there by clamping or by welding (see Figure 3 ).

[0029] The stimulation electrode 30 can be positively engaged with the fastening section 34 in the distal end 40a of the tube 40, more precisely in a section 48 of the tube 40 extending from the distal end 40a. The fastening section 34 can have one or more grooves 36 on its outer surface, which improve the clamping fixation of the fastening section 34 in the section 48 of the tube 40. The stimulation electrode 30, in particular the fastening section 34, can thereby close the distal end 40a of the tube 40. In order to nevertheless allow the escape of a fluid arranged in the gap 46 at the distal end of the device 10, the tube 40 can have at least one injection opening 42 in its wall, opening into the gap 46 between the stimulation wire 20 and the tube 40 (see Figure 1). Fig. 3 ) and / or the stimulation electrode 30 has an axial through-hole (not shown).

[0030] The proximal end 20b of the stimulation wire 20 projects beyond the proximal end 40b of the tube 40 and is bent around the proximal end 40b of the tube 40, particularly by about 180°, in a bending section 22, and guided to the outside of the tube 40. An electrically conductive stimulation cable 50, in particular an electrically conductive conductor 52 of the stimulation cable 50, is electrically connected to the proximal end 20b of the stimulation wire 20, which, in particular, with a return section 23 adjoining the bending section 22, lies on the outside of the tube 40. The electrically conductive contact of the stimulation wire 20 can thus take place outside the lumen of the tube 40, which is often filled with fluid during use, and without penetrating the wall of the tube 40.The stimulation cable 50, in particular the conductor 52 of the stimulation cable 50, can be electrically connected to the stimulation wire 20, in particular the returned section 23, for example by means of a crimp sleeve 25. As shown in the . Figures 1 and 4 As shown, an electrical connector 54 for connecting a control unit with pulse generator can be arranged at the other end of the stimulation cable 50.

[0031] An injection tube 60 is fitted section by section over the proximal end 40b of the tube 40, and in particular also section by section over the returned section 23 of the stimulation wire 20 located on the outside of the tube 40, sealingly. This can be achieved, for example, by ensuring that the inner diameter of the injection tube 60 corresponds approximately to the outer diameter AS of the tube 40. As shown in the Figures 1 and 4As shown, a syringe connection 64 can be arranged at the other end of the injection hose 60, via which, for example, a fluid, such as an anesthetic, can be injected into the injection hose 60 using a syringe, which enters the proximal end 40b of the hose 40 via the injection hose 60 and exits at the distal end 40a of the hose 40, in particular through the injection opening 42.

[0032] The proximal end 40b of the tube 40, with its connection to the stimulation cable 50 and the connection to the injection tube 60, can be arranged in a housing 70, wherein the stimulation cable 50 and the injection tube 60 exit the housing 70 proximally, in particular parallel to the longitudinal axis of the tube 40. The proximal end 40b of the tube 40, including the connection points, can be inserted into the housing 70 and additionally potted with an adhesive or alternatively overmolded with the housing 70. In this way, the connection points can be protected. One or more finger grips 72 can be arranged on the housing 70 for the insertion of a user's fingers to increase grip security.

[0033] A device 10 can be used for nerve stimulation through a natural body opening, for example the nose, the bladder owhich can be used in the vagina. For example, when inserted through the nose, nerve stimulation of the sphenopalatine ganglion can be performed with the stimulation electrode 30, or, for example, by applying low-frequency alternating current to the stimulation wire 20, or by injecting an anesthetic through the injection tube 60 and the tube 40, a blockage of the sphenopalatine ganglion can be performed in order to treat, for example, facial and headaches in migraine. Reference symbol list

[0034] 10 Device 20 Stimulation wire 20 distal end 20b proximal end 22 Bend section 23 Returned section 25 Crimp sleeve 30 Stimulation electrode 32 Outer surface 34 Mounting section 36 Groove 38 Blind hole 40 Tube 40 distal end 40b proximal end 42 Injection port 44 Mark 46 Gap 48 Section 50 Stimulation cable 52 Wire 54 Electrical connector 60 Injection tube 64 Syringe connection 70 Housing 72 Grip recess AD Diameter of stimulation wire AS Outer diameter of tube IS Inner diameter of tube AE Outer diameter of stimulation electrode L Length

Claims

1. Device (10) for nerve stimulation with an electrically conductive stimulation wire (20) with a diameter (AD), a distal end (20a) and a proximal end (20b), which is arranged in an electrically insulating tube (40) having an inside diameter (IS), an outside diameter (AS), a distal end (40a) and a proximal end (40b), wherein the inside diameter (IS) of the tube (40) is larger than the diameter (AD) of the stimulation wire (20), such that a gap (46) is formed for supplying fluid into the tube (40), characterised in that a stimulation electrode (30) is electrically conductively arranged at the distal end (20a) of the stimulation wire (20), which electrode protrudes beyond the distal (40a) end of the tube (40), and wherein the proximal end (20b) of the stimulation wire (20) protrudes beyond the proximal end (40b) of the tube (40) and is guided around the proximal end (40b) of the tube in a manner bent around onto the outside of the tube (40), wherein an electrically conductive stimulation electrode (50) is electrically conductively connected to the proximal end (20b) of the stimulation wire (20) and wherein an injection tube (60) is pulled in a sealing manner in portions over the proximal end (40b) of the tube (40).

2. Device according to any of the preceding claims, characterised in that the stimulation electrode (30) has a rounded outer surface (32) and is configured to be for example dome-shaped, spherical, ellipsoidal, mushroom-shaped, pear-shaped or egg-shaped.

3. Device according to either of the preceding claims, characterised in that the stimulation electrode (30) has an outside diameter (AE), at least in a cross-section, that is larger than the outside diameter (AS) of the tube (40).

4. Device according to any of the preceding claims, characterised in that the stimulation electrode (30) is arranged in a form-fitting manner, with a fastening portion (34), in the distal end (40a) of the tube (40), wherein the tube (40) comprises, in its wall, at least one injection opening (42) that leads into the gap (46) between the stimulation wire (20) and tube (40), and / or the stimulation electrode (30) comprises an axial through-opening.

5. Device according to any of the preceding claims, characterised in that the proximal end (40b) of the tube (40) is arranged with the connection point to the stimulation cable (50) and the connection point to the injection tube (60) in a housing (70), wherein the stimulation cable (50) and the injection tube (60) are guided out of the housing (70) proximally, in particular in parallel with the longitudinal axis of the tube (40).

6. Device according to any of the preceding claims, characterised in that the diameter (AD) of the stimulation wire (20) is less than 0.3 mm, preferably approximately 0.2 mm.

7. Device according to any of the preceding claims, characterised in that the stimulation wire (20) is produced from stainless steel.

8. Device according to any of the preceding claims, characterised in that the outside diameter (AS) of the tube (40) is less than 1.0 mm, preferably less than 0.9 mm.

9. Device according to any of the preceding claims, characterised in that the inside diameter (IS) of the tube (40) is in the range of 0.4 mm to 0.7 mm, preferably in the range of 0.5 mm to 0.6 mm.

10. Device according to any of the preceding claims, characterised in that the length (L) of the tube (40) is more than 10 cm, preferably more than 15 cm, particularly preferably more than 20 cm.

11. Device according to any of the preceding claims, characterised in that the tube (40) is produced from plastics material, for example a polyamide.

12. Device according to any of the preceding claims, characterised in that the tube (40) comprises markings (44) proceeding from the distal end (40a).

13. Device according to any of the preceding claims, characterised in that the device is suitable for nerve stimulation through a natural body opening.