WO2013011474A2

WO2013011474A2 - Nerve stimulation system

Info

Publication number: WO2013011474A2
Application number: PCT/IB2012/053676
Authority: WO
Inventors: Jacob GREENSHPAN
Original assignee: Greenshpan Jacob
Priority date: 2011-07-19
Filing date: 2012-07-19
Publication date: 2013-01-24
Also published as: WO2013011474A3

Abstract

A system for stimulating a nerve, comprising: an implantable electrode structure having a base and a plurality of electrodes; an implantable controller having a stimulator, adapted to deliver electrical pulses to the electrodes, a transmitter adapted to transmit signals to other components of the system, a receiver adapted to receive signals from other components of the system, and a processor adapted to process the various activities executed by system; and an implantable power source adapted to provide electrical power to the implantable controller. The implantable electrode structure further comprises a plurality of non-conductive branches extending from the base, and at least one of the electrodes located on the branches, thereby producing a three dimensional array of electrodes.

Description

NERVE STIMULATION SYSTEM

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

[001] This application claims priority from provisional patent application US 61/509,455, entitled "Erection Facilitator Device and Other Nerve Stimulator", filed on July 19, 2011; and from provisional patent application US 61/555,317, entitled "Erection Facilitator Device and Other Nerve Stimulator", filed on November 3, 2011, the entire contents of which are incorporated herein by reference. FIELD OF THE INVENTION

[002] The present invention relates to medical devices and methods, in particular for nerve stimulation.

BACKGROUND OF THE INVENTION

[003] Nerves are part of the peripheral and central nervous systems of humans and animals. Nerves convey signals from the skin and organs to the central nervous system and vice versa. Nerves may suffer functional defects due to normal wear and tear, physical injuries, infection and failure of blood vessels surrounding the nerves. These functional defects may be accompanied by pain, numbness, weakness, and in some cases, paralysis.

[004] One functional defect associated with damaged nerves is impotence, or erectile dysfunction (ED). ED is a medical condition in which a male patient is incapable of obtaining penile erection spontaneously. ED exists in many segments of the adult male population, and may be a result of psychogenic, vasculogenic, hormonal or neurogenic causes. ED occurs in high incidence after radical prostatectomy, radical cystectomy and abdominoperineal resection. In addition, ED occurs occasionally after transurethral resection of a prostate, external sphincterotomy, internal urethrotomy and prostatic abscess. Mechanical, vascular, neurological and psychological etiologies have been suggested.

[005] One technique for overcoming the nerve problems involves stimulating those nerves having a functional defect with an electro-medical device that is positioned near a target nerve. One such electro-medical device is commonly referred to as an Implantable Pulse Generator (IPG). An IPG typically includes one or more electrodes, an electrical pulse generator, a battery and a housing. The electrical pulse generator generates a waveform capable of stimulating the target nerve. When the electrodes receive the waveform from the generator, they draw energy from the battery and generate an electric field of suitable strength to stimulate the target nerve.

[006] Lue et al. in US Patent No. 4,585,005, titled "Method and Pacemaker for Stimulating Penile Erection", the entire contents of which is incorporated herein by reference, discloses an electrode implanted closely adjacent to the cavernous nerve of a human male, adjacent to his prostate gland. Each electrode is electrically connected to a receiver, subcutaneously implanted in the patient. An external transmitter is utilized to electrically energize the receiver to transmit electrical energy to the electrode and the cavernous nerves to stimulate penile erection.

[007] A similar apparatus for treating impotence incorporating a pulse generator and a lead for carrying electrical pulses from the pulse generator to the cavernous nerve is disclosed by Ardito and Knoll in US Patent No. 5,938,584, titled "Cavernous Nerve Stimulation Device", the entire contents of which is incorporated herein by reference.

[008] Zappala, in US Patent No. 6,993,390, titled "Implantable Device and

Method for Managing Erectile Dysfunction", the entire contents of which is incorporated herein by reference, discloses an implantable device comprising: at least one power source member, at least one pulse generating member and at least one electrode that is adapted to be implanted at the suprapubic level of the patient's neurovascular bundle of the phallus, and adapted to electrically stimulate the neurovascular bundle upon selective activation by the patient. However, the disclosure notes that optimal lead placement to the phallic neurovascular bundle via the dorsal vein is critical to the operation and success of the device.

[009] Villa Sanz et al. in PCT Publication No. WO 01/89630, titled "Urination, Defecation and Erection Control System in Neuropathy Patients", the entire contents of which is incorporated herein by reference, discloses a system for controlling incontinence, urination, defecation and erection in neutopathy patients by electrical stimulation of the sacral roots, which control bowel, bladder and sexual functions. The system comprises an implantable stimulator, a battery, a microprocessor and a command, when communication of the stimulator with the programmer and the command is carried out by telemetry.

[010] Electrodes are used also for controlling the function of other organs. For example, DiUbaldi in US Patent Application No. US 2009/093,858, titled "Implantable Pulse Generators and Methods for Selective Nerve Stimulation", the entire contents of which is incorporated herein by reference, discloses an implantable pulse generator including a surgically implantable housing, a battery, a first waveform generator, a second waveform generator, a modulator and electrodes. This implantable pulse generator is adapted to stimulate a target nerve or a body part.

[Oi l] Doggs II et al. in US Patent No. 7,047,078, titled "Methods for Stimulating

Components In, On, or Near The Pudendal Nerve or its Branches To Achieve Selective Physiologic Responses", the entire contents of which is incorporated herein by reference, discloses at least one electrode sized and configured to be located on, in, or near a targeted component of the pudendal nerve, that innervates the external genitalia as well as sphincters for the bladder and the rectum. The electrode is used for controlling physiological functions of the urinary tract.

[012] Skwarek et al. in US Patent No. 7,437,194, titled "Stimulating the Prostate

Gland", the entire contents of which is incorporated herein by reference, discloses techniques for providing electrical stimulation to the prostate gland of a patient, particularly for treating sexual dysfunction, benign prostatic hyperplasia, or other disorders. In addition, Tanagho et al. in US Patent No. 4,607,639, titled "Method and System for Controlling Bladder Evacuation", the entire contents of which is incorporated herein by reference, discloses a method for controlling the continence and evacuation of a bladder by positioning an electrode in close proximity to at least one nerve controlling at least one function of the bladder, and electrically energizing the electrode to simultaneously stimulate the nerve. Another system disclosed by Tanagho et al. in US Patent No. 4,771,779, titled "System for Controlling Bladder Evacuation", the entire contents of which is incorporated herein by reference, comprises first and second implanted stimulation systems having electrodes respectively positioned on nerves controlling external sphincter and bladder functions. Another implantable stimulator having at least two electrodes for delivering electrical stimulation to surrounding tissue, particularly for stimulating the prostate, is disclosed by Whitehurst et al. in US Patent No. 6,901,294, titled "Methods and Systems for Direct Electrical Current Stimulation as a Therapy for Prostatic Hypertrophy", the entire contents of which is incorporated herein by reference.

[013] One of the challenges in the stimulation of a nerve with an electrode is ensuring direct contact of the electrode with the nerve. In this respect, Tanagho et al. disclose in US Patent No. 4,940,065, titled "Surgically Implantable Nerve Electrode", the entire contents of which is incorporated herein by reference, an electrode adapted to be surgically implanted around a nerve bundle, comprising a biocompatible and dielectric carrier formable from a flattened, opened position to a closed position around the nerve bundle. Holsheimer and Struijk disclose in US Patent No. 5,643,330, titled "Multichannel Apparatus for Epidural Spinal Cord Stimulation", the entire contents of which is incorporated herein by reference, a multi-channel pulse generator driving a plurality of electrodes mounted near the distal end of a lead. The electrodes are positioned in a two dimensional array, and each electrode is wired and electrically stimulated separately. In addition, Boveja et al. in US Patent No. 7,330,762, titled "Method a System for Providing Pulsed Electrical Stimulation to Provide Therapy for Erectile/Sexual Dysfunction, Prostatitis, Prostatitis Pain, and Chronic Pelvic Pain", the entire contents of which is incorporated herein by reference, disclose a system for providing pulse electrical stimulation to various nerves, having a variety of different types of multiple electrodes at the distal end of a lead, including electrodes with an anchoring sleeve pulled back from the most proximal electrode, a paddle electrode, and electrodes wrapped around the nerve tissue to be stimulated. Gerber and Oleson also disclose in US Patent Application Publication No. US 2004/0049240, titled "Electrical and/or Magnetic Stimulation Therapy for the Treatment of Prostatitis and Prostatodynia", the entire contents of which is incorporated herein by reference, a variety of electrode types, including arrays of multiple electrodes, all of the electrodes in two-dimensional arrangements or cylindrical in shape, extending around the circumference of a lead body. This publication also discloses an external or internal drug pump that may be employed in conjunction with the electrical stimulation provided to the patient. SUMMARY OF THE INVENTION

[014] The present invention relates to a system and methods for stimulating a nerve. The system comprises a three-dimensionally configured structure of electrodes structure. The three dimensional configuration is a particular feature of the invention intended to provide a solution for the challenge of ensuring direct contact of an electrode with a nerve, in contrast to systems where electrodes are arranged in one or two- dimensions. The present system is suitable for stimulating any organ or body part that is controlled by the nervous system. [015] In some embodiments of the present invention the system is adapted to stimulate a nerve in the peripheral nervous system, the autonomous nervous system and the central nervous system, thus facilitating the enhancement of malfunctioning organs or body parts due to damaged nerves. For example, the system can be used to facilitate the control of the stomach by stimulating the appropriate nerves that control the various functions of the stomach; retrieving the ability of pineal erection for patients suffering from ED; or enhancing sexual stimulation by providing suitable electrical pulses to a nerve.

[016] In accordance with embodiments of one aspect of the present invention there is provided a system for stimulating a nerve, comprising: an implantable electrode structure having a base and a plurality of electrodes; an implantable controller having a stimulator, adapted to deliver electrical pulses to the electrodes, a transmitter adapted to transmit signals to other components of the system, a receiver adapted to receive signals from other components of the system, and a processor adapted to process the various activities executed by system; and an implantable power source adapted to provide electrical power to the implantable controller. The implantable electrode structure further comprises a plurality of non-conductive branches extending from the base, and at least one of the electrodes located on the branches, thereby producing a three dimensional array of electrodes.

[017] In accordance with embodiments of another aspect of the present invention there is provided, in combination with an implanted nerve stimulation system having at least one electrode which is both a transmitter and receiver, a method for determining which electrode is located near a nerve, comprising: transmitting an electrical signal from a first electrode; measuring electrical potential in the rest of the electrodes; determining in which electrode a higher electrical potential was measured; determining that the electrodes that measured a higher electrical potential are near the nerve that was stimulated by the first electrode; repeating the above cycle with all electrodes of the implantable electrode structure transmitting an electrical potential; and determining which electrodes are located near the same nerve.

BRIEF DESCRIPTION OF THE DRAWINGS [018] The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the appended drawings in which:

[019] Fig. 1 is a schematic view of an embodiment of a nerve stimulation system of the present invention;

[020] Fig. 2 is a perspective view of an exemplary implantable electrode structure of the nerve stimulation system of Fig. 1 ;

[021] Figs. 3a and 3b are perspective views of additional exemplary implantable electrode structures;

[022] Fig. 4 is a perspective view of the implantable electrode structure of Fig. 3b in the vicinity of a nerve;

[023] Fig. 5 is a schematic view of an implanted implantable electrode structure and an implantable electrode controller having a rechargeable battery being charged with an external battery charger;

[024] Fig. 6 is a schematic view of an implanted implantable electrode structure and an implantable electrode controller having a rechargeable battery that is connected to photo-galvanic cells and being charged by an external light source;

[025] Fig. 7 is a schematic view of an implantable electrode structure and an implantable electrode controller having a rechargeable battery that is connected to a transformer and charged by an external changing magnetic field;

[026] Fig. 8 is a perspective view of an embodiment of a remote controller;

[027] Fig. 9 is a side view of an embodiment of an injection device of an implantable controller and an implantable electrode structure;

[028] Fig. 10 is a cross-section side view of an exemplary implantable electrode structure having a branch with an inner tubule and openings;

[029] Fig. 11 is a side view of an exemplary implantable electrode structure adapted to produce an electrical potential in a specific site in a tissue; and

[030] Fig. 12 is a bottom sectional view of an exemplary implantable electrode structure in the vicinity of two nerves.

[031] The following detailed description of embodiments of the invention refers to the accompanying drawings referred to above. Dimensions of components and features shown in the figures are chosen for convenience or clarity of presentation and are not necessarily shown to scale. Wherever possible, the same reference numbers will be used throughout the drawings and the following description to refer to the same and like parts.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[032] Illustrative embodiments of the invention are described below. In the interest of clarity, not all features and components of an actual implementation are necessarily described.

[033] Fig. 1 shows an embodiment of a nerve stimulation system of the present invention, a portion of which is adapted to be implantable in a patient's body near the prostate. The nerve stimulation system comprises an implantable electrode structure 10, an implantable controller 20 and an implantable power source 30, all shown implanted in a patient's body; a remote controller 40; and a physician station 50.

[034] Fig. 2 shows details of implantable electrode structure 10 comprising a base

12 and a plurality of branches 14 extending from the base 12. The base 12 and branches 14 are made of a non-conductive material, and the tips 142 of the branches are typically sharp. At least one electrode 146 is placed on each branch 14, producing a three-dimensional array of electrodes. Electrodes 146 are made of a conductive material, e.g. a metal. In the embodiment shown in Fig. 2, branches 14 are generally cylindrical and electrodes 146 are ring-shaped and disposed at the perimeter (surface) of their respective branches. However, numerous other branch and electrode shapes can be used. Each electrode 146 is connected to a conductor such as wire 16, e.g. wire or conductor, adapted to transfer electrical stimulation to each electrode 146 separately and independently relative to the other electrodes 146. All the electrode wires 16 are connected to an electrode controller 18, adapted to transmit electrical pulses to the electrodes 146 via the electrode wires 16. The electrode controller 18 is disposed inside the base 12, and the electrode wires 16 that extend from the electrode controller 18, each electrode wire 16 directing to a single electrode 146is inside base 12 and branches 14. The electrode controller 18 is connected to the implantable controller 20, either wirelessly or via an electrode controller wire 182, enabling the implantable controller 20 to communicate with the electrode controller 18. In one embodiment, implantable controller 20 transmits commands to the electrode controller 18 (e.g. a command to activate a specific electrode 146; a command to activate several specific electrodes 146; and a command determining the parameters of electrical pulses transmitted via the electrodes 146, such as voltage, current, frequency of alternating current and pulse duration.

[035] The shape of the implantable electrode structure 10 is not limited to the rectangular shape shown in Fig. 2. Fig. 3a shows an embodiment of the implantable electrode structure 10 that is concave, and Fig 3b shows another embodiment, in which the implantable electrode structure 10 is convex. These embodiments should be considered as examples only. Thus, implantable electrode structure 10 is in a shape and dimensions adapted to fit the structure and dimensions of an implantation site in a patient's body and the patient's physiological needs. For example, the concave implantable electrode structure 10, shown in Fig. 3a, is adapted to treat medical conditions of rectal sphincter muscles due to damage to the cavernous nerve.

[036] Fig. 4 shows the way in which the three-dimensional arrangement of the electrodes 146 on the branches 14 of a concave implantable electrode structure 10 ensures stimulation of an adjacent nerve 900. Nerve 900 runs randomly inside a tissue, thus making it difficult to locate the nerve 900 and attach to it an electrode. The instant invention overcomes this problem by the three-dimensional arrangement of the electrodes 146 on the branches 14. In an embodiment shown in Fig. 4, implantable electrode structure 10 is placed in the vicinity of a nerve 900, while only electrodes 146a and 146b are in contact with the nerve 900 and allow transmission of electrical pulses to the nerve 900. On the other hand, the remaining electrodes 146 are not in contact with the nerve.

[037] In one embodiment of the present invention, the implantable controller 20 comprises a stimulator, adapted to deliver electrical pulses to the electrodes 146; a transmitter, adapted to transmit signals to other components of the system; a receiver adapted to receive signals from other components of the system; and a processor adapted to process the various activities executed by the nerve stimulation system, including but not limited to: electrical power management and electrode stimulation pattern. In some embodiments, the processor processes the activities following activation by a signal from an implanted or external source; or an implanted or external switch. In yet other embodiments, the processor is pre-programmed to execute activities automatically.

[038] In one embodiment of the present invention, implantable power source 30 is integrated with the implantable controller 20, while in another embodiment implantable power source 30 is separated from the implantable controller 20. The implantable power source 30, e.g. a capacitor or a battery, which can be either rechargeable or replaceable, can be of any kind known in the art. In an embodiment in which the implantable power source 30 is a replaceable battery, when the replaceable battery 30 is out of power it is removed from the patient's body and replaced by a fresh replaceable battery by any mean for removing and implanting objects from/into a patient's body known in the art, e.g. surgery and injection.

[039] In an embodiment in which the replaceable battery 30 is integrated with the implantable controller 20, the implantable controller 20 is removed from the patient's body by any method known in the art, the used-up replaceable battery 30 is replaced by a fresh rechargeable battery 30 and the implantable controller 20 is implanted back in the patient's body by any method known in the art.

[040] Fig. 5 shows an embodiment in which an implantable controller 20 with an integrated rechargeable battery 30a is implanted in a patient's body near the prostate. In this embodiment the rechargeable battery 30a is charged by an external charger 600, connected to a charging catheter 602, having at least one charging connector (not shown) at its tip 604. In order to charge the rechargeable battery 30a, the charging catheter 602 is temporarily passed through the urethra until the at least one charging connector come in contact with the implantable controller 20 and charge the integrated rechargeable battery 30a.

[041] In another embodiment, shown in Fig. 6, an implantable controller 20 with an implantable rechargeable battery 30b is implanted in a patient's body near the prostate. In this embodiment the implantable rechargeable battery 30b is connected to implantable photo-galvanic cells 700, via a connecting means, e.g. a photo-galvanic cell wire 702. The implantable photo-galvanic cells 700 are adapted to convert light energy to electricity. An external light source 704 is adapted to shed light on the body area under which the photo- galvanic cells 700 are implanted. An example of a light source, suitable for lightening the implantable photo-galvanic cells 700 is "soft laser", which is able to penetrate live tissues without heating extensively the tissue or causing any other damage to the tissue. Typically, the maximum penetration depth of a "soft laser" light beam is in the range of 30-45 mm. Therefore, the implantable photo-galvanic cells 700 are implanted under the skin in an appropriate distance. Lightening the spot under which the implantable photo-galvanic cells 700 are implanted with a "soft laser" light beam causes the implantable photo-galvanic cells 700 to convert the light energy that reaches the implantable photo-galvanic cells 700 to electricity, and the electricity is transferred to the rechargeable battery through the photo-galvanic wire 702.

[042] In other embodiments of the present invention, there is provided a system for charging an implantable rechargeable battery, comprising: implantable photo-glavanic cells 700 connected to an implantable rechargeable battery 30 via a connecting means 702; and an external light source 704, e.g. soft laser light source. The system is adapted to recharge an implantable rechargeable battery 30 supplying electricity to any implantable system or device known in the art, e.g. implantable pacemakers and implantable pumps.

[043] Fig. 7 shows an embodiment of an implantable controller 20 with an integrated rechargeable battery 30c implanted in a patient's body near the prostate. The rechargeable battery 30c is connected by a transformer connector 802 to an implantable transformer 800 adapted to convert a changing magnetic field to electricity. In the embodiment shown in Fig. 7 the implantable transformer 800 comprises coils and a metal core. The rechargeable battery 30c is charged by using an external magnetic field generator 804 adapted to produce a changing magnetic field. The magnetic field generator 804 is placed in the vicinity of the place in the patient's body where the implantable transformer 800 is implanted. When the magnetic field generator 804 is turned on, a changing magnetic field is produced, and converted to electricity by the implantable transformer 800, and the electricity is transferred through the transformer connector 802 to the rechargeable battery 30c, which is recharged.

[044] In other embodiments of the present invention, there is provided a system for charging an implantable rechargeable battery 30, comprising: an implantable transformer 800 connected to an implantable rechargeable battery 30 via a transformer connector 802; and an external magnetic field generator 804. The system is adapted to recharge an implantable rechargeable battery 30b supplying electricity to any implantable system or device known in the art, e.g. implantable pacemakers and implantable pumps.

[045] In yet another embodiment implantable power source 30 is a crystal, e.g. a quartz crystal, known in the art as generating an electrical potential in a given voltage and frequency, in response to an electromagnetic or electric current in the vicinity of the crystal.

[046] Fig. 8 shows an embodiment of an external remote controller 40, used outside the patient's body, and adapted to control the implantable controller 20 by transmitting information to and receiving information from the implantable controller 20. In one embodiment, shown in Fig. 8, the remote controller 40 comprises a display 44; at least one key 42; a communication module and a storage and processing unit (not shown as these components are inside the remote controller 40). The display 44 is adapted to display information regarding the function of the implantable controller 20. The at least one key 42 is adapted to be pressed by the user and trigger a function by the implantable controller 20. Examples of keys 42 include an "ON" key, which triggers the implantable controller 20 to start stimulating a nerve; an "OFF" key for stopping a stimulation of a nerve by the implantable controller 20; and a "CHECK" key for checking various aspects of the function of the implantable controller 20 and the remote controller 40, e.g. implantable power source 30 life. The communication module is adapted to enable a coded communication of the remote controller 40 with the implantable controller 20 and the physician station 50. In one embodiment the storage and processing unit comprises a micro-processor for storing and processing data, and is adapted to enable operations, e.g. processing the number and duration of functions stimulated by the implantable controller 20, like erection; blocking too frequent stimuli; monitoring and displaying implantable controller 20 status; and regulating the function of the remote controller 40. In another embodiment the display 44 is a touch screen adapted to display information and serve as a key.

[047] In one embodiment, as shown in Fig. 1, the nerve stimulation system includes a physician station 50, adapted to control various aspects of the function of the system. Examples of functions that are controlled by the physician station 50 include: display of function parameters; testing the performance of the system; calibrating the system; charging of a rechargeable battery 30a-c; emergency procedures when un-desired pulses are delivered to a patient's nerve; and supporting any procedure performed by a physician. In one embodiment the physician station 50 comprises a processor, e.g. a computer or a portable computer. In one embodiment the physician station 50 communicates wirelessly with the implantable controller 20. In another embodiment the physician station 50 is connected either wirelessly or by a wire with the remote controller.

[048] The implantable controller 20 and implantable electrode structure 10 are implanted in a patient's body using any suitable procedure, e.g. surgery and injection. The surgery procedure involves a placement of the implantable controller 20 and implantable electrode structure 10 in a patient's body using any surgery procedure known in the art, including but not limited to traditional, robotic and laparoscopic surgery technique. In one embodiment the transplant of the implantable controller 20 and implantable electrode structure 10 is conducted during a prostatectomy operation in cases neural erection malfunction is expected.

[049] Fig. 9 shows an embodiment of an injection device used during the injection procedure of the implantable controller 20 and implantable electrode structure 10. The implantable controller 20 and the implantable electrode structure 10 are placed inside the injection device 60 and then injected into a desired location in a patient's body. In one embodiment the injection of the implantable controller 20 and the implantable electrode structure 10 is accompanied by an imaging procedure, e.g. magnetic resonance imaging, computed tomography and ultra-sound scanning.

[050] Fig. 10 shows an embodiment of two branches 14a and 14b and an injecting branch 15 of an implantable electrode structure 10, of which injecting branch 15 is adapted to inject a fluid or a suspension into the vicinity of injecting branch 15 in a patient's body, e.g. a tissue or a nerve. Branches 14a and 14b have each at least one electrode 146. Injecting branch 15 has in its inner part at least one tubule 150, and at least one opening 152 along the injecting branch 15, the at least one opening 152 is a continuation of the tubule 150 in one side, and is open towards the surrounding space of the injecting branch 15. The at least one opening 152 is adapted to transfer a fluid or a suspension from the tubule 150 into the surrounding of injecting branch 15, e.g. a tissue or a nerve near injecting branch 15. The at least one tubule 150, is a continuation of a feeding tube 154, adapted to conduct a liquid or a suspension from a reservoir (not shown) into the at least one tubule 150. In another embodiment of the present invention, an implantable electrode structure 10 comprises at least one injecting branch 15 having at least one tubule 150 having at least one opening 152 and a feeding tube 154, as disclosed above. In yet another embodiment, injecting branch 15 further comprises at least one electrode 146. The injecting branch 15 having at least one electrode 146 is adapted to either inject a fluid or a suspension into the vicinity of the injecting branch 15, or to produce an electrical potential in a tissue near the electrode 146, or both simultaneously.

[051] In one embodiment a fluid is conducted through a feeding tube 154 into an at least one tubule 150 inside an injecting branch 15, and then injected through an at least one opening 152 into the surrounding of the injecting branch 15. Any type of fluid known in the art that is needed to be injected into a patient's tissue or on a nerve is injected, e.g.: a medication for curing a tissue or a nerve; a material, which upon injection onto a damaged area of a nerve hardens to a conductive material for supporting pulse conduction through the damaged area of the nerve.

[052] In yet another embodiment, a suspension is conducted through a feeding tube 154 into an at least one tubule 150 inside an injecting branch 15, and then injected through an at least one opening 152 into the surrounding of the branch 14. Any type of suspension known in the art that is needed to be injected into a patient's tissue or on a nerve is injected. An example of such a suspension is a suspension of stem cells to be injected onto or near a damaged area of a nerve. The injected stem cells adhere to the damaged nerve tissue and transform to a fresh nerve tissue, thus curing the damaged area of the nerve.

[053] In one embodiment of the present invention the three-dimensional arrangement of the electrodes 146 is adapted to produce an electrical potential in a specific site in a tissue, while abolishing or reducing the electrical potential in another site. To demonstrate this method, Fig. 11 shows an implantable electrode structure with electrode 146e between electrodes 146d and 146f and adjacent to them. Electrode 146e transmits an electrical signal. However this electrical signal might induce un-desired electrical signals in the adjacent electrodes 146d and 146f. In order to reduce or abolish the electrical potential in the area near electrode 146d, for example, electrode 146d transmits an electrical signal, which is in a phase 180° opposite relative to the phase of the electrical signal transmitted from electrode 146e. As a result of interference between the electrical signals transmitted from electrodes 146e and 146d, the electrical signal near electrode 146d is abolished or getting lower than the electrical potential near electrode 146e. This method is applicable also in embodiments in which it is desired to reduce or abolish the electrical potential near more than one electrode, e.g. reducing or abolishing the electrical potential near electrodes 146d and 146f when electrode 146e transmits an electrical signal. In this embodiment, both electrodes 146d and 146f transmit an electrical signal, which is in a phase 180° opposite relative to the phase of the electrical signal transmitted from electrode 146e.

[054] In one embodiment of the present invention, each electrode 146 is adapted to functions either as a transmitter or a receiver, or both. As a receiver, the electrode 146 is adapted to sense electrical potential or conductivity in its vicinity. As a transmitter the electrode 146 is adapted to electrically stimulate a nerve or tissue in its vicinity. In yet another embodiment at least one receiver electrode 146 is adapted to measure the electrical potential or conductivity of a tissue in response to an electrical stimulation by at least one another electrode 146.

[055] Fig. 12 is an embodiment of a bottom view of an implantable electrode structure 10 in the vicinity of two nerves 900a and 900b. A method for locating a nerve and determine which electrode 146 is near the nerve, using transmitter and receiver electrodes 146, is as follows. Since Fig. 12 is a bottom view of an implantable electrode structure 10, showing tips of branches 14, the disclosure will refer to electrodes 146 on the branches 14, even though the electrodes 146 are not seen in Fig. 12. A transmitter electrode 146, located on branch 14d, transmits an electrical stimulus. If branch 14d is located near nerve 900a, as shown in Fig. 12, then a receiver electrode 146 located on branch 14e, measures an electrical potential higher or similar to the electrical potential stimulated by electrode 146 on branch 14d, because both electrodes 146 are located near nerve 900a. On the other hand, a receiver electrodes located on branch 14f, which is not near a nerve, and a receiver electrode 146 located on branch 14g, which is located near nerve 900b, do not measure any increase in electric potential, because nerve 900a was stimulated by transmitter electrode 146 located on branch 14d. It should be noted that the method described using Fig. 12 is for locating a nerve two-dimensionally. However, since in one embodiment more than one electrode 146 is located on a branch 14, then the allocation of an electrode 146 near a nerve is conducted three-dimensionally.

[056] In one embodiment of the present invention, an implantable electrode structure 10, in which each electrode 146 is a transmitter and receiver all together, is implanted in a patient's body. A method for determining which electrode 146 is located near a nerve, in order to know which electrode 146 is to be used to stimulate the nerve, comprises: transmitting an electrical signal from a first electrode 146; measuring electrical potential in the rest of the electrodes 146; determining in which electrode 146 a higher electrical potential was measured; repeating the above cycle with all electrodes 146 on the implantable electrode structure 10 transmitting an electrical potential; determining which electrodes 146 are located near the same nerve. This method is adapted to determine which electrodes 146 are near the same nerve also when the implantable electrode structure 10 is planted near more than one nerve.

[057] In one embodiment of the present invention the nerve stimulation system is adapted to stimulate a nerve in order to activate a target organ in a patient's body. A more optimal activation of the target organ is achieved when the nerve innervating the target organ is stimulated in an as more distant point from the target organ. Thus, the method for determining which electrode 146 is located near a nerve is applied, in combination with an observation of the activity of the target organ. When the electrodes 146 that activate the target organ are determined, the organ is activated by stimulating the nerve innervating the target organ by the most distant electrode from the target organ.

[058] In yet another embodiment of the present invention the nerve stimulation system is adapted to cure a damaged nerve by an electrical stimulation at the damaged area of the nerve. Hao J. et al., in an article titled "Electric acupuncture treatment of peripheral nerve injury", published in the Journal of Traditional Chinese Medicine, Vol. 15(2), pp. 114-117, 1995, the entire contents of which are incorporated herein by reference, describe a method of curing a damaged nerve by electrical acupuncture. A method of curing a damaged nerve by an electrical stimulation at the damaged area of the nerve, comprises: implanting the implantable electrode structure 10 into a patient's body near a damaged nerve; allocating a damaged area of the nerve by employing the method for determining which electrode 146 is located near a nerve; and stimulating at least one electrode 146, which is near the damaged area of the nerve.

[059] In one embodiment of the present invention the nerve stimulation system is adapted to cure a damaged nerve by injecting an appropriate liquid or suspension near the damaged area of the nerve. A method of curing a damaged nerve by injecting a fluid or a suspension, comprises: implanting the implantable electrode structure 10 into a patient's body near a nerve suspected to be damaged; allocating a damaged area of the nerve by employing the method for determining which electrode 146 is located near a nerve; and injecting an appropriate liquid or suspension from an at least one injecting branch 15, which is near the damaged area of the nerve.

[060] In another embodiment of the present invention the nerve stimulation system is adapted to be part of a method of curing a damaged nerve using stem cells, by destroying stem cells that are not in the vicinity of the damaged nerve. This method is important in the sense that extra stem cells, not actively participating in the cure process of the damaged nerve, might spread in a patient's body and increase the chance for cancer and other ailments. This method is applicable when the damaged nerve is still partially active. The method comprises: implanting the implantable electrode structure 10 into a patient's body near a nerve suspected to be damaged; applying stem cells to the area of the damaged nerve; determining which electrode 146 is located near the nerve by employing the method for determining which electrode 146 is located near a nerve; and stimulating at least one electrode 146 that is not near the nerve with a high electrical potential, thereby destroying unnecessary stem cells that are not in the vicinity of the nerve.

[061] In one embodiment of the present invention the nerve stimulation system is adapted to enhance orgasm during sexual intercourse. In this embodiment an implantable electrode structure 10 is implanted near the pudendal nerve, which is responsible for much of the genitals sense. Then the electrodes 146 located near the pudendal nerve are determined by the method for determining which electrode 146 is located near a nerve as described above, and the pudendal nerve is stimulated during sexual intercourse to enhance orgasm, by stimulating the electrodes 146 that were determined as being near the pudendal nerve. In yet another embodiment a key 42 for controlling the stimulation of orgasm is included in the remote controller 40.

[062] A method for controlling the maximum number of erections per given time period, comprises: 1. pre-determining a maximal number of erections per given time period, e.g. a day, allowed for a given patient; 2. counting the number of erections stimulated by the nerve stimulation system during the given time period; 3. if the number of stimulated erections during the given time period equals the pre-determined maximal number of erections per the given time period, disabling an additional request for an erection; 4. Sending an order to the remote controller 40 to display a message to the patient regarding the disabling of the request for erection; 5. when the given time period is over, zeroing the counted number of erections per the given time period and starting over again from step 2; 6. If the condition of the given patient requires a change of the maximal number of erections per the given time period, starting over from step 1.

[063] A method for controlling the maximum duration of an erection comprises: 1. pre-determining a maximal duration of an erection allowed for a given patient; 2. measuring the duration of an erection stimulated by the nerve stimulation system; 3. if the duration of a stimulated erection equals the pre-determined maximal duration of erection, disabling the erection by terminating the electrical stimulation; 4. Sending an order to the remote controller 40 to display a message to the patient regarding the termination of the erection; 5. If the condition of the given patient requires a change of the maximal duration of an erection, starting over from step 1.

[064] Other methods that are employed when the nerve stimulation system is used for stimulating an erection, including but not limited to: a method for controlling a minimal interval between erections; a method for controlling time or frequency parameters of erections; and a method for blocking the function of the nerve stimulation system in cases when the system is over-used.

[065] Additional exemplary methods applied by the nerve stimulation system include, but are not limited to: a method for optimizing power consumption by minimizing voltage and current of the electrical pulse to optimal levels; a method for determining the minimal number of electrodes to stimulate a nerve; and a method for using effective electrodes in a rotational manner.

[066] Examples of media adapted to store algorithms that execute the various methods described above and others include, but not limited to: electrode controller 18 which is part of implantable electrode structure 10; a processor in implantable controller 20; remote controller 40; physician station 50; or a combination thereof.

[067] It should be understood that the above description is merely exemplary and that there are various embodiments of the present invention that may be devised, mutatis mutandis, and that the features described in the above-described embodiments, and those not described herein, may be used separately or in any suitable combination; and the invention can be devised in accordance with embodiments not necessarily described above.

Claims

1. A nerve stimulation system, comprising:

an implantable electrode structure having a base and a plurality of electrodes;

an implantable controller having a stimulator, adapted to deliver electrical pulses to the electrodes, a transmitter adapted to transmit signals to other components of the system, a receiver adapted to receive signals from other components of the system, and a processor adapted to process the various activities executed by the system; and

an implantable power source adapted to provide electrical power to the implantable controller,

wherein the implantable electrode structure further comprises a plurality of non-conductive branches extending from the base, and at least one of the electrodes located on the branches, thereby producing a three dimensional array of electrodes.

2. The system of claim 1, further comprising a remote controller adapted to receive and transmit information from and to other components of the system, thereby remotely controlling the implantable controller.

3. The system of claim 1, further comprising a physician station, adapted to receive and transmit information from and to other components of the system, thereby controlling the other components of the system.

4. The system of claim 1, wherein the implantable electrode structure is in a shape and dimensions adapted to fit the structure and dimensions of an implantation site in a patient's body and the patient's physiological needs.

5. The system of claim 1, wherein each electrode is controlled separately and independently.

6. The system of claim 1, wherein the at least one electrode is a transmitter, adapted to electrically stimulate a nerve or a tissue in its vicinity.

7. The system of claim 1, wherein the at least one electrode is a receiver, adapted to sense electrical potential or conductivity in its vicinity.

8. The system of claim 1, wherein the at least one electrode is both a transmitter and a receiver.

9. The system of claim 1, wherein the implantable electrode structure further comprises at least one injecting branch adapted to inject a fluid or a suspension into the vicinity of the injecting branch, wherein the injecting branch further comprises at least one tubule which is a continuation of a feeding tube, and at least one opening which is a continuation of the tubule.

10. The system of claim 9, wherein the injecting branch further comprising at least one electrode.

11. The system of claim 1, wherein the implantable power source is a rechargeable battery, and the system further comprises an external charger, connected to a charging catheter having at least one charging connector, whereby the external charger is adapted to charge the rechargeable battery by passing the charging catheter into a patient's body until the at least one charging connector come in contact with the implantable controller and charge the rechargeable battery.

12. The system of claim 1, wherein the implantable power source is a crystal, adapted to generate an electrical potential in response to an electromagnetic or electric current in the vicinity of the crystal.

13. A system for charging an implantable rechargeable battery, comprising:

an implantable rechargeable battery;

implantable photo-galvanic cells; and

an external light source,

the implantable rechargeable battery is connected to the implantable photo-galvanic cells via a connecting means, wherein the external light source is adapted to light the area of a patient's body under which the implantable photo-galvanic cells are implanted, and the implantable photo-galvanic cells are adapted to convert the light to electricity which is transferred to the implantable rechargeable battery via the connecting means.

14. The system of claim 13, wherein the external light source is a soft laser light source.

15. The system of claim 1, wherein the implantable power source is a rechargeable battery, and the system further comprises an external light source, and implantable photo- galvanic cells connected to the rechargeable battery via a connecting means, whereby the external light source is adapted to light the area of a patient's body under which the implantable photo-galvanic cells are implanted, and the implantable photo-galvanic cells adapted to convert the light to electricity which is transferred to the rechargeable battery via the connecting means.

16. The system of claim 15, wherein the external light source is a soft laser light source.

17. A system for charging an implantable rechargeable battery, comprising:

an implantable rechargeable battery;

an implantable transformer; and

an external magnetic field generator, the implantable rechargeable battery is connected to the implantable transformer via a transformer connector, wherein the external magnetic field generator is adapted to produce a changing magnetic field near the area of a patient's body under which the implantable transformer is implanted, and the implantable transformer is adapted to convert the changing magnetic field to electricity which is transferred to the rechargeable battery via the transformer connector.

18. The system of claim 1, wherein the implantable power source is a rechargeable battery, and the system further comprises an external magnetic field generator, and an implantable transformer connected to the rechargeable battery via a transformer connector, whereby the external magnetic field generator is adapted to produce a changing magnetic field near the area of a patient's body under which the implantable transformer is implanted, and the implantable transformer is adapted to convert the changing magnetic field to electricity which is transferred to the rechargeable battery via the transformer connector.

19. A method using a nerve stimulation system for producing an electrical potential in a specific site in a tissue, while abolishing or reducing the electrical potential in another site, comprising:

transmitting an electrical signal from a first electrode;

transmitting an electrical signal from a second electrode, which is in a phase 180° opposite relative to the phase of the electrical signal transmitted from the first electrode, thereby reducing or abolishing the electrical potential in the area near the second electrode.

20. A method using a nerve stimulation system for determining which electrode is located near a nerve, using an implantable electrode structure having electrodes which are both transmitters and receivers, comprising:

transmitting an electrical signal from a first electrode;

measuring electrical potential in the rest of the electrodes;

determining in which electrode a higher electrical potential was measured;

determining that the electrodes that measured a higher electrical potential are near the nerve that was stimulated by the first electrode;

repeating the above cycle with all electrodes of the implantable electrode structure transmitting an electrical potential; and

determining which electrodes are located near the same nerve.

21. A method of claim 20, for determining the most distant point of a nerve innervating an organ, further comprising: observing the activity of a target organ while transmitting an electrical signal from an electrode; and

determining the most distant electrode from the target organ still triggering activity of the organ.

22. A method of claim 20, for curing a damaged nerve by an electrical stimulation at the damaged area of the nerve, further comprising:

allocating a damaged area of the nerve according to the results of the method of claim

20; and

stimulating at least one electrode, which is near the damaged area of the nerve.

23. A method of claim 20, for curing a damaged nerve by injecting a fluid or a suspension near the damaged area of the nerve, further comprising:

Implanting an implantable electrode structure, having electrodes which are both transmitters and receivers and at least one injecting branch, near a nerve suspected to be damaged;

20; and

injecting an appropriate liquid or suspension from an at least one injecting branch, which is near the damaged area of the nerve.

24. The method of claim 20, for curing a damaged nerve by applying stem cells near the damaged area of the nerve and destroying the stem cells that are not near the damaged area of the nerve, further comprising:

applying stem cells to the area of a damaged nerve;

determining which electrodes are located near the nerve of claim 20; and

stimulating at least one electrode that is not near the nerve with a high electrical potential, thereby destroying unnecessary stem cells that are not in the vicinity of the nerve.

25. A method of claim 20, for enhancing orgasm during sexual intercourse, comprising:

Implanting an implantable electrode structure near the pudendal nerve;

determining which electrode is located near the pudendal nerve of claim 20; and stimulating the electrodes that were allocated near the pudendal nerve.

26. A method for controlling the maximum number of erections per given time period, using a nerve stimulation system implanted near a nerve controlling erection, the method comprising:

a. pre-determining a maximal number of erections per given time period; b. counting the number of erections stimulated by the nerve stimulation system during the given time period;

c. if the number of stimulated erections during the given time period equals the predetermined maximal number of erections per the given time period, disabling an additional erection;

d. when the given time period is over, zeroing the counted number of erections per the given time period and starting over again from step b;

e. changing the maximal number of erections per given time period, by starting over from step a.

27. The method of claim 26, further comprising sending an order to a remote controller to display a message regarding the disabling of the erection, after step c.

28. A method for controlling the maximal duration of an erection, using a nerve stimulation system implanted near a nerve controlling erection, the method comprising:

a. pre-determining a maximal duration of an erection;

b. measuring the duration of an erection stimulated by the nerve stimulation system; c. if the duration of a stimulated erection equals the pre-determined maximal duration of erection, disabling the erection by terminating the electrical stimulation;

d. changing of the maximal duration of an erection, starting over from step a.

29. The method of claim 28, further comprising sending an order to a remote controller to display a message regarding the termination of the erection, after step c.