Device for nerve stimulation

Abstract

The invention relates to a device (10) for nerve stimulation having an electrically conductive stimulation wire (20) having a diameter (AD), a distal end (20a) and a proximal end (20b), the stimulation wire being arranged in an electrically insulating hose (40) having an inner diameter (IS), an outer diameter (AS), a distal end (40a) and a proximal end (40b), the inner diameter of the hose being greater than the diameter of the stimulation wire, so that a gap (46) for supplying a fluid is formed in the hose, a stimulation electrode (30) is arranged at the distal end of the stimulation wire in an electrically conductive manner, which stimulation electrode projects beyond the distal end of the hose, and wherein the proximal end of the stimulation wire projects beyond the proximal end of the hose and is guided to the outside of the hose in a curved manner about the proximal end of the hose, and wherein an electrically conductive stimulation cable (50) is electrically conductively connected to the proximal end of the stimulation wire, and wherein the stimulation electrode (30) is electrically conductively connected to the proximal end of the stimulation wire. An injection hose (60) is sectionally sleeved on the proximal end of the hose to form a seal.

Description

Technical Field

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

[0002] It is known to transmit current pulses, such as low-frequency alternating current, at low voltage by means of electrodes placed on the skin for pain relief or to relieve muscle tension, in order to stimulate nerves transcutaneously in this way. However, the skin is a relatively large transition resistor in this case. In addition, the stimulation is usually carried out over a large area. Summary of the invention

[0003] It is therefore an object of the present invention to provide an improved device for nerve stimulation which is particularly widely usable and with which preferably a more direct stimulation can be carried out.

[0004] The object of the invention is achieved by a device for nerve stimulation having the features of the invention.

[0005] Advantageous embodiments and developments of the invention are specified in the dependent claims.

[0006] According to the present invention, the device for nerve stimulation includes a conductive stimulation wire having a diameter, a distal end and a proximal end, wherein the conductive stimulation wire is arranged in an electrically insulating hose having an inner diameter, an outer diameter, a distal end and a proximal end, wherein the inner diameter of the hose is larger than the diameter of the stimulation wire, thereby forming a gap in the hose for supplying fluid, wherein a stimulation electrode is arranged in a conductive manner at the distal end of the stimulation wire, the stimulation electrode protrudes beyond the distal end of the hose, and wherein the proximal end of the stimulation wire protrudes beyond the proximal end of the hose and is guided to the outside of the hose in a curved manner around the proximal end of the hose, wherein a conductive stimulation cable is conductively connected at the proximal end of the stimulation wire, and wherein the injection hose is segmentally sleeved on the proximal end of the hose to form a seal.

[0007] The device according to the invention is suitable both for nerve stimulation and for supplying fluids, such as anesthetics. Since the stimulation line is arranged in the lumen of the hose, a particularly compact structure is produced according to the invention. The stimulation line bent at the proximal end of the hose enables simple attachment of the stimulation cable to the outside of the hose without having to guide the stimulation line through the wall of the hose, thereby avoiding possible leaks.

[0008] Due to the flexibility of the hose, a thin and flexible device can also be provided, which can be introduced into the body through a trocar or an indwelling trocar, and can also be introduced into the body through a natural body opening, such as the nose, bladder or vagina, without making an incision in the skin. In this way, nerve stimulation can also be performed, which is difficult or impossible to achieve with stimulation electrodes attached to the skin outside the body.

[0009] According to an advantageous improvement of the invention, the stimulation electrode has a rounded outer surface and is designed, for example, in a dome, sphere, ellipsoid, mushroom, pear or egg shape. The rounded design avoids damage to the patient's body. In addition, this design of the stimulation electrode simplifies the advancement of the device, in particular the advancement into the body opening.

[0010] A preferred embodiment of the invention provides that the stimulation electrode has an outer diameter that is greater than the outer diameter of the hose at least in one cross section. In other words, at least the maximum outer diameter of the stimulation electrode is greater than the outer diameter of the hose. This design allows the stimulation electrode to have as large a surface as possible, which improves the stimulation behavior of the stimulation electrode.

[0011] In principle, it is conceivable that the fluid can escape at the distal end of the hose between the stimulation electrode and the hose wall. Advantageously, the stimulation electrode is arranged in the distal end of the hose in a form-fitting manner with a fastening section, wherein the hose has at least one injection opening in its wall leading to the gap between the stimulation line and the hose, and / or the stimulation electrode has an axial through-opening. The form-fitting arrangement enables the distal end of the stimulation line to be stabilized within the hose. In addition, the form-fitting arrangement enables the closure of the distal end of the hose to prevent particles from entering the distal end of the hose and even to prevent a blockage of the distal end of the hose. In this embodiment, the fluid can escape laterally through at least one injection opening arranged in the hose wall and / or through the axial through-opening of the stimulation electrode.

[0012] Preferably, the proximal end of the hose is arranged in the housing with a connection point to the stimulation cable and a connection point to the injection hose, wherein the stimulation cable and the injection hose protrude from the housing at the proximal end, in particular parallel to the longitudinal axis of the hose. Here, the proximal end of the hose including the connection point can be inserted into the housing and additionally encapsulated with an adhesive or overmolded with the housing. In this way, the connection point can be arranged in a protected manner.

[0013] The diameter of the stimulation wire is preferably less than 0.3 mm, preferably about 0.2 mm. In this way, a thin and flexible stimulation wire may be provided which may be easily advanced into the body, in particular into a natural body opening.

[0014] Preferably, the stimulation wire is made of special steel, such as stainless steel. In this way, the required stability of the stimulation wire can be achieved, especially in the case of a length greater than 10 cm.

[0015] According to a particularly preferred embodiment of the invention, the outer diameter of the hose is less than 1.0 mm, preferably less than 0.9 mm. This allows a device for nerve stimulation to be dimensioned so that it can be easily introduced into the body, in particular into a natural body opening.

[0016] Preferably, the inner diameter of the hose is in the range of 0.4 mm to 0.7 mm, preferably in the range of 0.5 mm to 0.6 mm. This dimensioning achieves a sufficiently large gap between the inner wall of the hose and the stimulation wire to be able to guide fluid through the hose from the proximal end to the distal end.

[0017] According to a preferred improvement of the present invention, the length of the hose is greater than 10 cm, preferably greater than 15 cm, particularly preferably greater than 20 cm, for example 32.2 cm. Thus, sufficient length is provided so that the device for nerve stimulation can be pushed far enough into the body, for example into a natural body opening.

[0018] A preferred embodiment of the present invention provides that the hose is made of a synthetic material, such as plastic, such as polyamide. Such a material can achieve sufficient sealing, high flexibility and good biocompatibility.

[0019] Preferably, the hose has markings starting from the distal end, which allow the user to see how far the hose has been inserted into the body.

[0020] According to the invention, the device according to the invention is used for neurostimulation through natural body openings, such as the nose, bladder or vagina. For example, when inserted through the nose, the sphenopalatine ganglion can be neurostimulated, or when an anesthetic is injected, the sphenopalatine ganglion can also be blocked, so that facial pain and head pain in migraines can be treated, for example. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The present invention will be described in detail below with reference to the accompanying drawings. In the accompanying drawings:

[0022] Figure 1 is a side view of one embodiment of a device for neural stimulation according to the present invention;

[0023] Figure 2 is based on Figure 1 A detailed view of the distal end of the device;

[0024] Figure 3 is based on Figure 2 A longitudinal section of the distal end;

[0025] Figure 4 is based on Figure 1 A partial cross-sectional view of the device; and

[0026] Figure 5 yes Figure 4 Enlarged cross-section of . DETAILED DESCRIPTION

[0027] Figures 1 to 5Different views of one embodiment of a device 10 for neural stimulation are shown. For the sake of greater clarity, not all reference numerals are given in all figures.

[0028] The device 10 comprises a conductive stimulation wire 20 having 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 made of special steel, such as stainless steel. The diameter AD of the stimulation wire 20 may be less than 0.3 mm, preferably about 0.2 mm.

[0029] Furthermore, the device 10 comprises an electrically insulating hose 40 having an inner diameter IS, an outer diameter AS, a distal end 40a and a proximal end 40b. The hose 40 is in particular a flexible, sealed and biocompatible hose 40. The hose 40 may, for example, be made of a synthetic material, such as plastic, preferably polyamide. The outer diameter AS of the hose 40 is preferably less than 1.0 mm, particularly preferably less than 0.9 mm, and may, for example, be 0.87 mm. The inner diameter IS of the hose 40 is greater than the diameter AD of the stimulation wire 20, and may be in the range of 0.4 mm to 0.7 mm, preferably in the range of 0.5 mm to 0.6 mm, for example 0.54 mm. The length L of the hose 40 is greater than 10 cm, preferably greater than 15 cm, particularly preferably greater than 20 cm, for example 32.2 cm. Starting from the distal end 40a, the hose 40 may have a marking 44 (see Figure 1 and Figure 4 ), these markings 44 are particularly equidistantly arranged and can provide the user with information about how far the distal end 40a of the hose 40 has been introduced into the body.

[0030] The stimulation wire 20 is arranged in the hose 40, in particular guided through the lumen of the hose 40. Since the inner diameter IS of the hose 40 is greater than the diameter AD of the stimulation wire 20, in this case, a gap 46 is formed in the hose 40, in particular in the form of an annular gap between the stimulation wire 20 and the inner wall of the hose 40, through which a fluid can be guided from the proximal end 40b of the hose 40 to the distal end 40a of the hose 40, as described in more detail below.

[0031] At the distal end 20a of the stimulation line 20, a stimulation electrode 30 is arranged in an electrically conductive manner, which protrudes beyond the distal end 40a of the hose 40. The stimulation electrode 30 can have a rounded outer surface 32 and be designed, for example, in a dome-shaped, spherical, ellipsoidal, mushroom-shaped, pear-shaped or egg-shaped or in any other spherical manner. Due to the convex design of the stimulation electrode 30, the stimulation electrode 30 has a maximum outer diameter AE in at least one cross section. This outer diameter AE of the stimulation electrode 30 is greater than the outer diameter AS of the hose 40 (see in particular Figure 2 and Figure 3 ).

[0032] The electrically conductive connection between the stimulation line 20 and the stimulation electrode 30 can be established, for example, in that the distal end 20a of the stimulation line 20 is introduced into a blind hole 38 arranged in the stimulation electrode 30 or in a fastening section 34 arranged in the stimulation electrode 30 or is fixed there by clamping or by welding (see Figure 3 ).

[0033] The stimulation electrode 30 can be arranged in a form-fitting manner in the distal end 40a of the hose 40, more precisely in the section 48 of the hose 40 starting from the distal end 40a, using the fastening section 34. The fastening section 34 can have one or more grooves 36 on its outer side, which improve the clamping fixation of the fastening section 34 in the section 48 of the hose 40. The stimulation electrode 30, in particular the fastening section 34, can thus close the distal end 40a of the hose 40. However, in order to enable the fluid arranged in the gap 46 to escape at the distal end of the device 10, the hose 40 can have at least one injection opening 42 in its wall that leads to the gap 46 between the stimulation line 20 and the hose 40 (see Figure 3 ), and / or the stimulation electrode 30 may have an axial through-opening (not shown).

[0034] The proximal end 20b of the stimulation wire 20 protrudes beyond the proximal end 40b of the hose 40 and is guided to the outside of the hose 40, in particular in a bend section 22, around the proximal end 40b of the hose 40, in particular in a bend of about 180°. The conductive stimulation cable 50, in particular the conductive cable core 52 of the stimulation cable 50, is conductively connected to the proximal end 20b of the stimulation wire 20, and the proximal end 20b rests on the outside of the hose 40, in particular by means of a return section 23 connected to the bend section 22. Thus, conductive contact of the stimulation wire 20 can be achieved outside the cavity of the hose 40, which is often filled with fluid during use, but without penetrating the wall of the hose 40. The stimulation cable 50, in particular the cable core 52 of the stimulation cable 50, can be conductively connected to the stimulation wire 20, in particular the return section 23, for example, by means of a crimping sleeve 25. As shown in FIG. Figure 1 and Figure 4 As shown, an electrical connector 54 for connecting a control device to a pulse generator may be arranged at the other end of the stimulation cable 50 .

[0035] The injection hose 60 can be placed in sections on the proximal end 40b of the hose 40 and in this case also in sections on the return section 23 of the stimulation line 20 located outside the hose 40, so as to form a seal. This can be achieved, for example, in the following way, that the inner diameter of the injection hose 60 corresponds approximately to the outer diameter AS of the hose 40. In particular, Figure 1 and Figure 4As shown, a syringe connector 64 can be arranged at the other end of the injection hose 60, through which a fluid, such as an anesthetic, can be injected into the injection hose 60 using a syringe, for example. The fluid enters the proximal end 40b of the hose 40 through the injection hose 60 and is discharged at the distal end 40a of the hose 40, especially through the injection opening 42.

[0036] The proximal end 40b of the hose 40 can be arranged in the housing 70 with a connection site to the stimulation cable 50 and a connection site to the injection hose 60, wherein the stimulation cable 50 and the injection hose 60 exit the housing 70 proximally, in particular parallel to the longitudinal axis of the hose 40. Here, the proximal end 40b of the hose 40 including the connection site can be inserted into the housing 70 and additionally encapsulated with an adhesive or alternatively overmolded with the housing 70. In this way, the connection site can be arranged in a protected manner. One or more gripping recesses 72 for resting the user's fingers to increase gripping safety can be arranged on the housing 70.

[0037] The device 10 can be used for neurostimulation through a natural body opening, such as the nose, bladder, or vagina. For example, when inserted through the nose, the sphenopalatine ganglion can be neurostimulated with the stimulation electrode 30 when, for example, a low-frequency alternating current is applied to the stimulation wire 20, or the sphenopalatine ganglion can be blocked when an anesthetic is injected through the injection hose 60 and the hose 40, so that facial pain and head pain during migraine can be treated, for example.

[0038] Description of reference numerals:

[0039] 10. Installation

[0040] 20 Stimulation Line

[0041] 20a Distal

[0042] 20b Proximal

[0043] 22 Bend Section

[0044] 23 Return section

[0045] 25 Crimp sleeve

[0046] 30 Stimulation electrodes

[0047] 32 External surface

[0048] 34 Fastening section

[0049] 36 Grooves

[0050] 38 Blind hole

[0051] 40 Hose

[0052] 40a Distal

[0053] 40b Proximal

[0054] 42 Injection opening

[0055] 44 Marks

[0056] 46 Gap

[0057] 48 sections

[0058] 50 Stimulation Cable

[0059] 52 Cable core

[0060] 54 Electrical connectors

[0061] 60 Injection hose

[0062] 64 Syringe connector

[0063] 70 Shell

[0064] 72 Grip recess

[0065] Diameter of AD stimulation wire

[0066] AS hose outer diameter

[0067] IS hose inner diameter

[0068] AE stimulation electrode outer diameter

[0069] L Length

Claims

1. A device (10) for nerve stimulation, comprising a conductive stimulation wire (20), the conductive stimulation wire (20) having a diameter (AD), a distal end (20a) and a proximal end (20b), the conductive stimulation wire (20) being arranged in an electrically insulating hose (40) having an inner diameter (IS), an outer diameter (AS), a distal end (40a) and a proximal end (40b), wherein: The inner diameter (IS) of the hose (40) is larger than the diameter (AD) of the stimulation wire (20), thereby forming a gap (46) in the hose (40) for supplying fluid, wherein a stimulation electrode (30) is arranged in a conductive manner at the distal end (20a) of the stimulation wire (20), and the stimulation electrode (30) protrudes beyond the distal end (40a) of the hose (40), and wherein the proximal end (20b) of the stimulation wire (20) protrudes beyond the proximal end (40b) of the hose (40) and is guided to the outside of the hose (40) in a curved manner around the proximal end (40b) of the hose (40), wherein a conductive stimulation cable (50) is conductively connected to the proximal end (20b) of the stimulation wire (20), and wherein an injection hose (60) is segmentally sleeved on the proximal end (40b) of the hose (40) to form a seal.

2. The device according to any one of the preceding claims, characterized in that The stimulation electrode (30) has a rounded outer surface (32) and is designed, for example, in a dome-shaped, spherical, ellipsoidal, mushroom-shaped, pear-shaped or egg-shaped form.

3. The device according to any one of the preceding claims, characterized in that The stimulation electrode (30) has, at least in one cross section, an outer diameter (AE) which is greater than the outer diameter (AS) of the hose (40).

4. A device according to any one of the preceding claims, characterised in that The stimulation electrode (30) is arranged in the distal end (40a) of the hose (40) in a form-fitting manner using a fastening section (34), wherein the hose (40) has at least one injection opening (42) in its wall leading to the gap (46) between the stimulation line (20) and the hose (40), and / or the stimulation electrode (30) has an axial through-opening.

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

6. A device according to any one of the preceding claims, characterised in that The diameter (AD) of the stimulation wire (20) is less than 0.3 mm, preferably about 0.2 mm.

7. A device according to any one of the preceding claims, characterised in that The stimulation wire (20) is made of special steel.

8. A device according to any one of the preceding claims, characterised in that The outer diameter (AS) of the hose (40) is smaller than 1.0 mm, preferably smaller than 0.9 mm.

9. A device according to any one of the preceding claims, characterised in that The inner diameter (IS) of the hose (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. The device according to any one of the preceding claims, characterized in that The length (L) of the hose (40) is greater than 10 cm, preferably greater than 15 cm, particularly preferably greater than 20 cm.

11. The device according to any one of the preceding claims, characterized in that The hose (40) is made of a synthetic material, such as polyamide.

12. A device according to any one of the preceding claims, characterised in that The hose (40) has a marking (44) starting from the distal end (40a).

13. Use of a device (20) according to any of the preceding claims for nerve stimulation through a natural body opening.

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