DEVICE AND METHOD FOR NEUROMODULATION

Abstract

The present invention relates to a preoperative test method, to an implantation system (20) and to an implantation method for implanting a neuroprosthesis in the area of the pubic bone (31), wherein implantation is ultimately simplified and made more effective directly or indirectly by the subject-matters of the invention.

Claims

1. A preoperative test method for implanting a neuroprosthesis comprising a pacemaker (21) and an electrode array for the most direct stimulation possible of nerves (19) in the genital area (12), the method comprising: placing removable, electrodes (30) on the body surface of a genital area of the patient; inducing in the patient a physical condition exhibiting symptoms to be treated with the neuroprosthesis; energizing the electrodes (30) with a test current recording change caused in the symptoms by energization of the electrodes (30)

2. The method according to claim 1, wherein the electrodes (30) are adhesive electrodes.

3. The method according to claim 1, wherein the electrodes (30) are energized with a test current with current pulses of 150 s to 250 s in length, preferably with a frequency of 10 Hz to 50 Hz, especially preferably with an amplitude of 5 mA to 60 mA.

4. The method according to claim 3, wherein the electrodes are energized with a frequency of 10 Hz to 50 Hz.

5. The method according to claim 3, wherein the electrodes are energized with an amplitude of 5 mA to 50 mA.

6. The method according to claim 1, wherein a first electrode (30.1) is placed in the area of the clitoris or of the root of the penis and a second electrode (30.2) is placed laterally offset at the same height, preferably at a distance of 2 to 3 cm from an outer labium or at a lateral offset of 2 to 3 cm from the root of the penis.

7. The method according to claim 6, wherein laterally offset placement of the second electrode (30.2) is performed successively on both sides of the body, and upon each placement, at least the method steps of inducing a physical condition exhibiting the symptoms to be treated with the neuroprosthesis, energizing the electrodes (30) with a test current and recording the change caused in the symptoms by the energization of the electrodes (30) are executed.

8. The method according to claim 6, wherein each laterally offset placement of the second electrode (30.2) is performed at a different height with respect to the first electrode (30.1), and upon each placement, at least the method steps of inducing a physical condition exhibiting the symptoms to be treated with the neuroprosthesis, energizing the electrodes (30) with a test current and recording the change caused in the symptoms by the energization of the electrodes (30) are executed.

9. The method according to claim 6, wherein a multiple electrode comprising a plurality of spatially adjacent and electrically separate and individually controllable individual electrodes is used as the second electrode (30.2) and the method is performed in such a manner that the different electrodes are energized in a temporal order.

10. The method according to claim 6, wherein the first electrode (30.1) is energized as a cathode and the second electrode (30.2) is energized as an anode, polarity preferably reversing during energization and the change caused in the symptoms by energization being recorded as a function of the polarity of the electrodes (30).

11. The method according to claim 1, wherein the physical symptoms comprise urinary incontinence, fecal incontinence and/or erectile dysfunction.

12. An implantation system (20) comprising a curved hollow needle applicator (1) which can accommodate a tip (4) in a shaft (6) surrounding a hollow needle channel, the tip (4) being comprised by the system and removable at a front end, or can accommodate a wire electrode means (8) at the front end, the wire electrode means (8) being comprised by the system, wherein the hollow needle applicator (1) comprises a measuring device (11) by means of which a user can determine how far the wire electrode means (8) has been introduced into the shaft (6) of the hollow needle applicator (1) at the front end.

13. The system according to claim 12, wherein the shaft (6) of the hollow needle applicator (1) is equipped with a window (10) is provided with a mark marking a minimum position or a minimum introduction depth of the wire electrode means (8) in(to) the shaft (6).

14. The system according to claim 13, wherein the window is provided with a mark marking a minimum position or a minimum introduction depth of the wire electrode means (8) in(to) the shaft (6).

15. The system according to claim 12, wherein the wire electrode means (8) has a fixing means on a contact portion (9), the fixing means allowing the wire electrode means (8) to be fixed to a cartilage and/or bone structure.

16. The system according to claim 29, wherein the wire electrode means (8) has a mobile fixing means in a shaft portion, the mobile fixing means allowing the wire electrode means (8) to be fixed to a cartilage and/or bone structure, the mobile fixing means preferably being configured in such a manner that it allows movement relative to the hollow needle applicator (1).

17. An implantation method for a wire electrode means (8) into the pelvic area of a body (13), the implantation method comprising the method steps of: producing a first temporary implantation channel (7) running from the genital area (12) behind the pubic bone (31) to the abdominal wall (5) for receiving the wire electrode means (8); introducing the wire electrode means (8) into the first implantation channel (7) from the abdominal wall (5) in such a manner that a contact portion (9) of the wire electrode means (8) protrudes from the body (13); producing a second temporary implantation channel (17) which runs under the pubic bone (31) in the genital area (12) and whose exit area (15) from the body (13) coincides with an entry area (16) of the first implantation channel (7) located in the genital area (12), the contact portion (9) of the wire electrode means (8) thus being introducible into the second implantation channel (17), transferring the contact portion (9) of the wire electrode means (8) protruding from the body (13) into the second implantation channel in such a manner that electrodes (24) disposed in the contact portion (9), are placed in the area of the roots of the nerves (19) in the genital area (12).

18. The method according to claim 17, wherein the introducing step is carried out in such a manner that the contact portion (9) protrudes from the first implantation channel (7), in the genital area.

19. The method according to claim 17, wherein the second temporary implantation channel (17) is produced in the area of the pelvic floor.

20. The method according to claim 17, wherein the electrodes (24) are circumferential electrode means.

21. The method according to claim 17, wherein the wire electrode means (8) is anchored to a cartilage and/or bone structure, preferably to the pubic bone (31).

22. The method according to claim 21, wherein the cartilage and/or bone structure is the pubic bone (31).

23. The method according to claim 21, wherein the wire electrode means (8) has a fixing means on the contact portion (9), the fixing means allowing the wire electrode means (8) to be fixed to the bone and/or cartilage structure.

24. The method according to claim 21, wherein the wire electrode means (8) has a mobile fixing means in a shaft portion, the mobile fixing means allowing the wire electrode means (8) to be fixed to the cartilage and/or bone structure.

25. The method according to claim 17, wherein the first and/or the second implantation channel (17) is/are produced using a curved hollow needle applicator (1) which comprises a hollow needle channel enclosed by a shaft (6) and forming the respective implantation channel.

26. The method according to claim 25, wherein, in the first and/or the second implantation channel (17), a tip (4) is disposed on and can be removed from the hollow needle applicator (1) at the front end, and wherein the tip (4) blocks access to the hollow needle channel and fills part of the hollow needle channel.

27. The method according to claim 26, wherein the tip (4) is extracorporeally removed from the hollow needle applicator (1) at the front end after production of the implantation channel.

28. The method according to claim 25, wherein in the production of the first implantation channel (7), a curved hollow needle applicator (1) is introduced while being in contact with the lower edge of the pubic ramus until it penetrates the urogenital diaphragm, the retropubic space and the abdominal wall (5), exit from the abdominal wall (5) being performed in such a manner that exit occurs above the pubic bone (31) and a shaft (6) of the hollow needle applicator (1) surrounding the hollow needle channel is in contact with the pubic bone (31).

29. The method according to claim 25, wherein after introduction of the wire electrode means (8) into the hollow needle channel, the hollow needle applicator (1) is removed from the body (13) by being retracted.

30. The method according to claim 29, wherein the hollow needle applicator (1) is retracted in the direction of a puncture or in the direction of an entry point.

31. The method according to claim 17, wherein producing the first implantation channel (7) comprises making an incision, the incision being made in the genital area (12) of the body (13), 0.5 cm to 1.5 cm below the external urethral meatus or 0.5 cm to 1.5 cm below the infrapubic parapenile.

32. The method according to claim 17, wherein producing the second implantation channel (17) comprises making a second incision, the second incision, on a median axis of the body, being made below the caudal border of the inferior pubic ramus, just above the root of the penis or the clitoral glands and laterally offset therefrom by 3 mm to 5 mm.

33. The method according to claim 17, wherein a connecting end of the wire electrode means (8) that faces away from the contact portion (9) is connected to a pacemaker (21) which is placed behind the pubic bone (31), opposite the contact portion (9) of the wire electrode means (8).

34. The method according to claim 17, wherein the surgical method steps are performed under general anesthesia, spinal anesthesia or epidural anesthesia.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0058] Hereinafter, the invention will be illustrated based on schematic drawings.

[0059] FIGS. 1 to 9 illustrate different method steps for performing the implantation method for a wire electrode means of a neuroprosthesis;

[0060] FIGS. 10a to 10c are schematic illustrations showing an implantation system according to the invention; is an exemplary illustration in connection with a performance of the preoperative test method for an implantation of a neuroprosthesis; and

[0061] FIG. 11 is a further illustrates implantation methods according to the invention.

DETAILED DESCRIPTION

[0062] FIG. 1 shows a first method step for performing the implantation method. The exemplary illustration of the implantation method is described with reference to the body of a human female. However, the implantation method according to the invention can also be performed on male bodies and on bodies of mammals having an anatomy similar to that of the human body. In the first method step of FIG. 1, a paravulvar incision 2 or first incision 2 is made, which allows a hollow needle applicator 1 to be introduced into paravulvar incision 2. Alternatively, a first puncture can be made. The incision and path of hollow needle applicator 1 are selected such that hollow needle applicator 1 is introduced behind and in direct contact with the dorsal part of the pubic bone, the path of hollow needle applicator 1 preferably being controlled and/or monitored with two fingers 3 inserted into the vagina. Hollow needle applicator 1 is not directed at the center (lesion of the urethra), but at an angle to the center so as to be able to exit between the median plane of the body and the groin area on the same side of the body as the vulvar incision. In the process, abdominal wall 5 behind the pubic bone is transfixed by hollow needle applicator 1.

[0063] Paravulvar incision 2 or first incision 2, which serves to produce a first implantation channel 7, is preferably made 0.5 cm to 1.5 cm below the external urethral meatus or 0.5 cm to 1.5 cm below the infrapubic parapenile.

[0064] In the illustration of FIG. 2, the situation after completion of a first method step and during performance of a second method step is shown. Hollow needle applicator 1 including a tip 4 removable at the front end has emerged from abdominal wall 5, for which purpose curved hollow needle applicator 1 is guided while being in contact with the lower edge of the pubic ramus until it penetrates the urogenital diaphragm and the retropubic space and reaches the abdominal wall, the exit from abdominal wall 5 preferably being performed in such a manner that the exit happens above the pubic bone and a shaft 6 enclosing a hollow needle channel of hollow needle applicator 1 preferably is in partial contact with the pubic bone. The directional arrow in the illustration of FIG. 2 additionally indicates the retrograde removal of tip 4, which is removable from hollow needle applicator 1 and blocks access to the hollow needle channel, shaft 6 of hollow needle applicator 1, which surrounds the hollow needle channel, forming a first implantation channel 7 after removal of tip 4.

[0065] FIG. 3 illustrates once more the path of hollow needle applicator 1 during production of first implantation channel 7, for which purpose hollow needle applicator 1 is moved from behind pubic bone 31 through the avascular retropubic space.

[0066] FIG. 4 illustrates a subsequent method step in which a wire electrode means 8 is introduced with a contact portion 9 first into first implantation channel 7, which is formed by the hollow needle channel of hollow needle applicator 1 and limited by shaft 6 of hollow needle applicator 1. This means that after removal of tip 4 from the front end or retrograde end of hollow needle applicator 1, wire electrode means 8 is also retrogradely introduced into hollow needle applicator 1 starting with the end that comprises electrodes 24 or the contact portion. To ensure that wire electrode means 8 are introduced far enough, but not too far into the first implantation channel, the shaft of hollow needle applicator 1 has a window 10 having a scale or mark (not shown), window 10 together with the mark and/or scale serving as a measuring device 11 with which the user can determine how far wire electrode means 8 has been introduced into shaft 6 of hollow needle applicator 1 at the front end or retrograde end.

[0067] After introduction of wire electrode means 8 into shaft 6 of hollow needle applicator 1 and thus into first implantation channel 7, a sufficiently far, but not too far introduction being preferably ensured via measuring device 11 of hollow needle applicator 1 during introduction of wire electrode means 8, hollow needle applicator 1 is removed from the body in a method step not shown, hollow needle applicator 1 being removed by retraction of hollow needle applicator 1 in the direction of incision 2 or in the direction of the point of entry of hollow needle applicator 1.

[0068] This results in a situation as schematically illustrated in FIG. 5. After removal of hollow needle applicator 1, wire electrode means 8 is accommodated in first implantation channel 7 from the direction of the abdominal wall in such a way that a contact portion 9 of wire electrode means 8 protrudes from body 13 in genital area 12, the contact portion of wire electrode means 8 protruding from the first incision or paravulvar incision 2.

[0069] Another method step is outlined in FIG. 6. In the course of the next method step, hollow needle applicator 1 with reinserted tip 4 is introduced from the top to the bottom as deeply as possible through a second median supravulvar incision or second incision 14 and exits again through first incision 2 or paravulvar incision 2. Hollow needle applicator 1 is guided ventral of the pubic bone, but as closely as possible along the pubic bone so as to ensure that wire electrode means 8, in particular contact portion 9, is placed as deeply within the body as possible. The reintroduction of hollow needle applicator 1, starting from second incision 14 and exiting from first incision 2 as illustrated in FIG. 6, produces a second temporary implantation channel in the genital area, in particular in the area of the pelvic floor below the pubic bone, whose exit area from body 13 coincides with an entry area 16 of first implantation channel 7 in genital area 12. In this way, second implantation channel 17 is produced between second incision 14 and first incision 2 via shaft 6 of hollow needle applicator 1.

[0070] Following the production of second implantation channel 17, removable tip 4 is again removed from hollow needle applicator 1 at the retrograde end or front end. After removal of tip 4, wire electrode means 8 is introduced into shaft 6 of hollow needle applicator 1 from the retrograde end or front end with contact portion 9 first, shaft 6 again providing and maintaining the second implantation channel, as outlined in FIG. 7.

[0071] FIG. 8 shows a subsequent state of the implantation method, in which, after removal of hollow needle applicator 1, the wire electrode means, in particular contact portion 9, have reached their final position. Preferably, a fixing means provided in contact portion 9 may be used to fix the wire electrode means to, for example, the pubic bone by means of non-absorbable suture material in order to prevent migration of wire electrode means 8, in particular of contact portion 9. Also, both incisions 2 and 14 are closed, for which absorbable suture material can preferably be used. In another method step (not shown), a pacemaker is fixed or installed behind the pubic bone through a minilaparotomy. Once the pacemaker has been fixed behind the pubic bone, a connecting end or connection portion 18 of wire electrode means 8 is connected to the pacemaker so as to be able to transmit electrical impulses to the nerves in the genital area via the electrodes in contact portion 9.

[0072] FIG. 9 once more illustrates the advantages of the implantation method described above, in which contact portion 9 of implanted wire electrode means 8 is placed and fixed in direct proximity to nerves 19 to be stimulated while the guiding of the wire electrode means behind pubic bone 31 and around pubic bone 31 ensures a particularly good prevention of a shift or migration of wire electrode means 8 following implantation. The pacemaker, which is not shown in FIG. 9 and which is preferably also installed behind pubic bone 31, is ideally protected against external trauma by being placed there. Overall, the method described above leads to a very reliable and robust implantation of the neuroprosthesis for stimulating the nerves in the genital area as directly as possible.

[0073] FIGS. 10a-10c show an example of an embodiment of an implantation system 20 according to the invention comprising a hollow needle applicator 1 including a tip 4 insertable into and removable from shaft 6 of hollow needle applicator 1, wire electrode means 8, and a pacemaker 21 along with pacemaker fixing means 22. Pacemaker 21 and pacemaker fixing means are optional components of system 20. As is apparent from the two different side vies of pacemaker 21 and wire electrode means 8, at a front end or distal end 23 on which contact portion 9 with electrodes 24 are also disposed, the wire electrode means have a first fixing means 25 with which the end of wire electrode means 8 can be fixed or attached. Preferably, fixing means 25 is used to fix wire electrode means 8 to a cartilage and/or a bone. To this end, non-absorbable suture means (not shown in FIGS. 10a-10c) can be used in addition to fixing means 25. Furthermore, wire electrode means 8 comprises, in a shaft portion 26, a second fixing means 27 which is mobile so as to be movable along wire electrode means 8. Second fixing means 27, too, can be used to additionally fix wire electrode means 8, preferably to the pubic bone. To this end, in the implanted state of wire electrode means 8, mobile second fixing means 27 along wire electrode means 8 can be moved into a position that allows fixation as ideal as possible and protection of wire electrode means 8 against migration.

[0074] The illustrations of FIGS. 10a-10c also shows that hollow needle applicator 1 comprise a handle 28 and a measuring device 11 in the area of shaft 6, measuring device 11 being realized in the form of a window 10 provided with a scale 29 or mark, for example. In an alternative embodiment, too, measuring device 11 allows the user to determine how far wire electrode means 8 have been introduced into hollow needle applicator 1. Particularly preferably, the measuring device can be set or individualized so as to be adjustable to a body or patient, preferably based on the records of the preoperative test method.

[0075] FIG. 11 shows a schematic illustration in connection with the performance of the preoperative test method according to the invention. A placement of two removable, preferably adhesive electrodes 30 in genital area 12 of a body 13 is shown. Once electrodes 30 have been placed, a physical condition that exhibits certain symptoms to be treated is induced in the preoperative test method. After or during induction of the physical condition, electrodes 30 are fed or energized with a test current. The test current can preferably have current pulses of 150 to 250 s in length and preferably with a frequency of 10 to 50 Hz, particularly preferably an amplitude of 5 to 60 mA. A first electrode 30.1 is placed in the area of the clitoris or in the area of the root of the penis, whereas second electrode 30.2 is placed at about the same height, but at a lateral distance of 2 to 3 cm from an outer labium or laterally offset by 2 to 3 cm from the root of the penis. Preferably, the lateral placement of electrode 30.2 can be performed successively on both sides or halves of the body. Likewise, the laterally offset placement of second electrode 30.2 can also be performed at different heights in addition to a placement at about the same height as first electrode 30.1. In both instances, i.e. placement of second electrode 30.2 on different sides or halves of the body and placement of second electrode 30.2 at different heights, the physical condition exhibiting symptoms to be treated is preferably induced or maintained and the electrodes are energized with a test current in order to record or register the changes in the physical symptoms. Instead of a change of the lateral distance between the two electrodes 30.1 and 30.2 and alternatively to a change of the height of second electrode 30.2 relative to first electrode 30.1 a multiple electrode which has multiple individual electrodes that are spatially adjacent and electrically separated from one another and which can be controlled individually can be used to reproduce or replace the lateral variation. Preferably, first electrode 30.1 is energized as a cathode and second electrode 30.2 is energized as an anode. Advantageously, polarity can reverse, in which case the change in the physical symptoms is also recorded as a function of the respective polarity.

[0076] The preoperative test method and the record of the change in the physical symptoms form the basis for the later determination regarding a therapeutic outcome to be expected after final implantation of a neuroprosthesis and for optimal performance of an implantation method because the records obtained on the changes in symptoms can also be used to draw conclusions as to an ideal implantation site for the electrodes, in particular for the contact portion of the wire electrode means, and the implantation method can be performed optimally.

REFERENCE SIGNS

[0077] 1 hollow needle applicator [0078] 2 paravulvar incision, first incision [0079] 3 finger [0080] 4 tip [0081] 5 abdominal wall [0082] 6 shaft [0083] 7 first implantation channel [0084] 8 wire electrode means [0085] 9 contact portion [0086] 10 window [0087] 11 measuring device [0088] 12 genital area [0089] 13 body [0090] 14 supravulvar incision, second incision [0091] 15 exit area [0092] 16 entry area [0093] 17 second implantation channel [0094] 18 connecting portion [0095] 19 nerves [0096] 20 implantation system [0097] 21 pacemaker [0098] 22 pacemaker fixing means [0099] 23 front end or distal end [0100] 24 electrodes [0101] 25 first fixing means [0102] 26 shaft portion [0103] 27 second fixing means [0104] 28 handle [0105] 29 scale [0106] 30 electrodes [0107] 30.1 First electrode [0108] 30.2 second electrode [0109] 31 pubic bone