WO2018118928A2

WO2018118928A2 - Systems and methods for the treatment of erectile dysfunction

Info

Publication number: WO2018118928A2
Application number: PCT/US2017/067326
Authority: WO
Inventors: Raul E. PEREZ; Bevil Hogg
Original assignee: Decurion LLC
Current assignee: Decurion LLC
Priority date: 2016-12-21
Filing date: 2017-12-19
Publication date: 2018-06-28
Anticipated expiration: 2019-06-21
Also published as: WO2018118928A3

Abstract

System and method focused on reversing the erectile dysfunction condition through a long term therapy is disclosed. The system comprises wirelessly controlled contact electrodes that are positioned in contact with the outer surface of the penis and/or the pelvic floor area to stimulate certain vital parts which have a significant role in enabling the erectile function of penis. Contact electrodes are powered through wireless transmission of energy. Regeneration of the smooth muscle mass in corpora cavernosa and the pelvic floor area is achieved through long term therapeutic treatment. The device can also be used in preventing reduction in the existing level of smooth muscle mass in penis.

Description

SYSTEMS AND METHODS FOR THE TREATMENT OF ERECTILE DYSFUNCTION

CROSS-REFERENCE

The present specification relies on, for priority, United States Patent Provisional Application Number 62/437,626, entitled "Systems and Methods for the Treatment of Erectile Dysfunction" and filed on December 21, 2016, which is herein incorporated by reference in its entirety.

FIELD

The present specification relates generally to treatment of erectile dysfunction and more particularly to a system for stimulating the penis and enhancing the smooth muscle mass in the penis and/or muscle strength in the pelvic floor area.

BACKGROUND

Erectile dysfunction (ED) is a sexual disorder characterized by an inability to develop or maintain an erection of the penis during sexual activity. Penile erection results from the hydraulic effect of blood entering and subsequently retained within the penis. Sexual arousal is typically the origination of penile erection, as signals are transmitted from the brain to nerves located in the penis. This is a complex process that involves the brain, hormones, nerves, muscles, blood vessels and emotions, whereby a deficiency in any of the foregoing can result in erectile dysfunction. The most common causes of erectile dysfunction are physiological factors such as cardiovascular diseases, diabetes, neurological problems, hormonal insufficiencies and drug side effects. Psychological factors such as stress, anxiety and mental health concerns can also cause or worsen an erectile dysfunction condition.

In a research study conducted on American men it was observed that ED affects about

20-30 million men older than 50 years. It was also estimated in this study that 5% of men in their 40s, 10% of men in their 60s, and 20% of men in their 70s will have complete erectile dysfunction. Another study conducted on a sample of 1709 men in a Boston suburban area reported that 52% of men aged 40-70 years had some degree of ED. Of these, 10% had complete ED, 25%) moderate and 17% minimal. The study also revealed that the prevalence of erectile dysfunction increases with age with the moderate and complete ED increasing most markedly. It was also observed that the percentages of erectile dysfunction were increased further by the addition of risk factors for ED especially those for vascular disease including history of cardiac disease, anti-hypertensive or vasoactive drug use and tobacco use.

The human penis is made up of several parts - nerves, blood vessels, fibrous tissue, smooth muscle, and three cylindrical chambers of tissue that fill with blood when the penis is erect. These three cylindrical chambers of spongy tissue comprise two chambers of corpora cavernosa that run along on the length of the penis on the dorsal side and a single chamber of corpus spongiosum, located between the two corpora cavernosa chambers that run along the length of the penis on the ventral side. The corpora cavernosa and the corpus spongiosum are primarily filled with soft tissue comprising smooth muscle fibers and connective tissue, together with sinusoids, which fill with blood during the erection. Any reduction in the smooth muscle mass of the corpora cavernosa and the corpus spongiosum impacts the erectile quality and a signification reduction in smooth muscle mass leads to complete erectile dysfunction. Impaired nitric oxide bioactivity is also a major cause of erectile dysfunction. Factors such as aging, inactivity, smoking, high cholesterol, fatty diets, and lack of healthy foods cause deficiency of nitric oxide in the body.

A portion of the pelvic floor muscles (PFM) such as ischiocavernosus (IC) muscles and bulbocavernosus (BC) muscles play a critical function in achieving penile erection. The IC and BC muscles surround the inner portions of the corpora cavernosa chambers and corpus spongiosum chamber, respectively. These pelvic muscles support the root of the penis and when they contract they push pressurized blood into the external penis, creating a stiff and rigid erection. Loss of strength in the pelvic floor muscles can seriously impact erectile function. PFM "dysfunction" is a common condition referring to when the PFMs are not functioning properly. The PFM can become weakened, flabby and as a result, function poorly functional due to various factors such as weight gain, a sedentary lifestyle, poor posture, injury, and sexual inactivity which lead to their loss of tone, texture and function. With aging, there is a decline in the bulk and contractility of the PFM, often resulting in PFM dysfunction.

Clinically, an erection is caused by an increase in blood pressure due to the relaxation of the smooth muscle fibers of the penis, while, conversely, loss of erection is primarily related to the contraction of smooth muscle in the penis. Sensory stimulation that causes erection can be physical or emotional, coming from either the body (skin and genitalia), or from the brain in the shape of fantasy, visual impacts, and/or smell. Regardless of the source of stimulation, the nerve signals pass along the spinal cord and through the nervi erigentes, nerves that contain preganglionic, parasympathetic motor fibers to the genitalia that are involved in innervation of and subsequent erection of the penis. These nerve cells release nitric oxide, which causes the smooth muscle fibers of the arteries and corporal bodies of the penis to relax. As these muscles relax, blood flow into the penis is promoted, and pressure increases, causing erection. Physiological factors such as diseases, drug use or age impacts the smooth muscle mass in the penis and leads to ED. Studies showed that young men have just over 50% smooth muscle mass in the penis, decreasing with age to 30% or even lower. Loss of erectile strength is also related to and is a direct effect of the loss of smooth muscle mass. A sufficient amount of smooth muscle mass is essential for optimal erectile quality.

Conventional treatment of erectile dysfunction often requires combinations of psychogenic and medical therapies. The first line of treatment comprises oral phosphodiesterase type 5 (PDE-5) inhibitors (such as Viagra), which has significantly enhanced erectile dysfunction treatment as patients have demonstrated high tolerability and success rates for improved erectile function. Penile tissue produces a nucleotide cGMP (Cyclic guanosine monophosphate) in response to the release of nitric oxide by the body. The erection is maintained by cGMP which is broken down by the enzyme PDE5. PDE5 inhibitor drugs prevent the breakdown of cGMP by PDE5 enzymes and help in maintaining erection quality and durability. In patients for whom the first-line therapy or changes in lifestyle fail to improve erectile function and who are motivated to continue with therapeutic alternatives, second-line therapy is available. This includes intracavernosal injection therapy, vacuum erection device therapy and intraurethral and topical medication administration.

However, the conventional treatments described above have achieved only moderate success and have significant limitations. PDE5 inhibitor drugs have several side effects and therefore cannot be used by every individual. For example, it is not recommended in men who have a history of stroke or myocardial infarction, significantly low blood pressure, uncontrolled high blood pressure, unstable angina, severe cardiac failure, and severe liver impairment among other conditions. In several cases, such as in the case of diabetics, PDE5 inhibitor drugs have very limited impact. Further, none of the conventional modes of treatment focuses on enhancing the natural erectile function by regenerating the smooth muscle mass in the corpora cavernosa and corpus spongiosum in the penis.

Physical exercises are recommended to enhance the strength of pelvic floor muscles, which include ischiocavernosus (IC) and bulbocavernosus (BC) muscles. However, this method requires a serious and conscious effort over a very long period of time to achieve a small improvement in pelvic floor muscle strength through physical conditioning. Currently, there is no reliable and convenient method available to enhance the strength of pelvic floor muscles within a definite period of time.

Currently, there is very little knowledge about how smooth muscle mass can be increased the penis. United States Patent Number 8,391,971, to Boston Scientific Scimed, describes "an apparatus for locally inhibiting smooth muscle tone to cause dilation of arterioles within an arterial bed, the apparatus comprising: a first electrode and a second electrode, wherein the first and second electrodes are configured to be inserted into an artery that feeds the arterial bed, wherein the artery and arterial bed includes arterial tissue and the arterial tissue includes smooth muscle tissue and an endothelium; a power supply; and an electronic controller configured to couple the power supply to the electrodes, wherein the controller is configured to use the electrodes to induce and maintain positive charges within the artery feeding the arterial bed to induce and maintain hyper polarization of the endothelium, locally inhibiting smooth muscle contraction to cause dilation of arterioles within the arterial bed".

A primary focus of the medical fraternity for treating ED has been on acute treatment of

ED with medications such as PDE5 inhibitors that causes instantaneous or one-off response. Therefore, there is a need for improved solutions to treat erectile dysfunction. Further there is a need for solutions which have little or no side effects that can be used by individuals who cannot use PDE5 inhibitor drugs or who do not show a positive response to PDE5 inhibitor drugs. Current treatments based on the PDE5 inhibitor or similar drugs mainly focus on achieving a momentary erection during the sexual activity and do not significantly enhance long-term erectile function. Therefore, there is a need for methods and systems that focus on significantly enhancing erectile function and reversing erectile dysfunction in the long term.

There is also a need to develop therapies and solutions that increase the percentage of smooth muscle mass in the corpora cavernosa and corpus spongiosum in the penis and therefore permanently reverse the erectile dysfunction condition. In addition, there is a need to provide solutions that can help in maintaining the amount of smooth muscle mass in the penis. Systems and methods are also required to improve the strength of pelvic floor muscles.

SUMMARY

In some embodiments, the present specification is directed toward a system for treating erectile dysfunction comprising: a plurality of electrodes to stimulate at least one of the cavernous nerve, arterial blood vessels, the corpus spongiosum, and the smooth muscle cells in the corpora cavernosa of the penis; and, a control unit for controlling the operation of said electrodes and providing energy to said electrodes.

In some embodiments, the present specification discloses a method for treating erectile dysfunction comprising: providing a plurality of electrodes to stimulate at least one of the cavernous nerve, arteries, arterioles or the smooth muscle cells in the corpora cavernosa of the penis; and controlling the operation of said electrodes and providing energy to said electrodes through wireless transmission.

In some embodiments, the present specification discloses a medical therapy for treating erectile dysfunction comprising: pre-defining a schedule for conducting the stimulation sessions for electrically stimulating at least one of the cavernous nerve, arterial blood vessels and the smooth muscle cells in the corpora cavernosa of the penis; placing a plurality of electrodes on the outer surface of the penis to provide electrical stimulation and transmitting energy to said electrodes through a wireless network; and controlling the operation of said electrodes to conduct the stimulation sessions in accordance with said pre defined schedule.

In some embodiments, the present specification discloses a system for treating erectile dysfunction in a patient, comprising: a plurality of electrodes arranged to deliver electrical stimulation to at least one of a cavernous nerve of a penis of the patient, arterial blood vessels of the penis of the patient, a corpus spongiosum of the penis of the patient, or smooth muscle cells in a corpora cavernosa of the penis of the patient by direct physical contact with an outer skin surface of the penis; and a control unit in electrical communication with the plurality of electrodes and configured to control an operation of said plurality of electrodes by providing energy to one or more of the plurality of electrodes to generate said electrical stimulation, wherein the electrical stimulation is provided for at least 30 minutes in a single treatment session and wherein an amperage of the electrical stimulation is less than 20 mA. Optionally, the control unit is configured to deliver energy to the plurality of electrodes through wireless transmission.

Optionally, the control unit is configured to power the plurality of electrodes using at least one of a wireless power transmitter, a resonant induction coupling method, or a radio frequency (RF) transmitter.

Optionally, the plurality of electrodes are coupled to a ring-shaped device configured to be worn over the penis.

Optionally, said ring shaped device is configured to be stretchable and expandable.

Optionally, said system further comprises an adjustable band and said plurality of electrodes are embedded in the adjustable band which is configured to be worn over the penis. Optionally, the adjustable band comprises Velcro.

Optionally, the plurality of electrodes are coupled to a condom-shaped wearable sheath configured to be worn over the penis.

Optionally, the plurality of electrodes are coupled to individual, adhesive patches which are configured to be attached to the outer skin surface of the penis.

Optionally, the electrical stimulation is configured such that, upon delivering the electrical stimulation, smooth muscle cells in the corpora cavernosa relax and thereby compress veins to stop an outflow of blood leading to penis erection.

Optionally, the electrical stimulation is configured such that, upon delivering the electrical stimulation, degeneration of smooth muscle mass in the penis is prevented and erectile quality is maintained.

Optionally, the electrical stimulation is configured such that, upon delivering the electrical stimulation, regeneration of smooth muscle mass in the penis is achieved and erectile quality is enhanced.

Optionally, the electrical stimulation comprises a current of 3mA and wherein the control unit is configured to apply the electrical stimulation for a period of time lasting at least 15 minutes and at least once per week over a period of one month.

Optionally, the control unit is configured to apply the electrical stimulation daily for a minimum of 30 minutes and with a current of at least 10mA. Optionally, control unit is configured to apply the electrical stimulation over a period of at least one month and over more than one session, wherein each of the more than one sessions has a pre-defined duration.

Optionally, the control unit is configured to apply the more than one session while the patient is asleep.

Optionally, the control unit is configured to be manually controlled by the patient through at least one of an activation of one of the plurality of electrodes, a deactivation of one of the plurality of electrodes, or a changing a level of electrical stimulation.

Optionally, the control unit is a hand-held device, which comprises programmatic instructions configured to control an operation of the control unit.

Optionally, the control unit provides a visual or auditory interface to guide the patient on how to titrate electrical stimulation based on an input from the patient.

Optionally, the control unit is configured to automatically adjust electrical stimulation parameters, wherein the electrical stimulation parameters comprise at least one of an electrical stimulation frequency, an electrical stimulation amplitude, an electrical stimulation duration, or an electrical stimulation vacation eligibility.

Optionally, the system further comprises an impedance measurement device or a strain gauge wherein the impedance measurement device or the strain gauge is coupled to the penis to record an effect of the electrical stimulation. Optionally, the impedance measurement device or the strain gauge is configured to measure changes in a dimension of the penis. Optionally, the impedance measurement device or the strain gauge is configured to detect tumescence by measuring changes in blood pressure and flow rate in the penis.

Optionally, the control unit is configured to receive data from the impedance device and analyze the data to determine a success level of the electrical stimulation.

Optionally, said control unit is coupled to a remote network and all information related to stimulation sessions is stored on a remote server connected to said remote network. Still optionally, a physician treating the user can access information related to stimulation sessions from said remote server and can program the stimulation sessions as a part of a long term treatment, wherein programming the stimulation sessions comprises defining timing, frequency, duration and degree of said stimulation sessions. In some embodiments, the present specification discloses a system for treating erectile dysfunction comprising: a plurality of electrodes arranged to deliver electrical stimulation at least one of a cavernous nerve of a penis of the patient, arterial blood vessels of the penis of the patient, a corpus spongiosum of the penis of the patient, or smooth muscle cells in a corpora cavernosa of the penis of the patient by being implanted proximate a base of the penis; and a control unit in electrical communication with the plurality of electrodes and configured to control an operation of said plurality of electrodes by providing energy to one or more of the plurality of electrodes to generate said electrical stimulation, wherein the electrical stimulation is provided for at least 30 minutes in a single treatment session and wherein an amperage of the electrical stimulation is less than 20 mA.

Optionally, the control unit is configured to apply the electrical stimulation daily for a minimum of 30 minutes and with a current of at least 10mA.

Optionally, the control unit is configured to apply the electrical stimulation over a period of at least one month and over more than one session, wherein each of the more than one sessions has a pre-defined duration.

Optionally, the control unit is configured to apply the more than one session while the patient is asleep. Optionally, the control unit is configured to be manually controlled by the patient through at least one of an activation of one of the plurality of electrodes, a deactivation of one of the plurality of electrodes, or a changing a level of electrical stimulation.

Optionally, said control unit is a hand held device, which comprises programmatic instructions configured to control an operation of the control unit.

Optionally, said control unit provides a visual or auditory interface to guide the patient on how to titrate electrical stimulation based on an input from the patient.

Optionally, said control unit is configured to automatically adjust electrical stimulation parameters, wherein the electrical stimulation parameters comprises at least one of an electrical stimulation frequency, an electrical stimulation amplitude, an electrical stimulation duration, or an electrical stimulation vacation eligibility.

In some embodiments, the present specification discloses a therapy for treating erectile dysfunction in a patient, comprising: defining a schedule for applying a plurality of electrical stimulation sessions to a penis of the patient; placing a plurality of electrodes on an outer skin surface of the penis or the pelvic floor of the patient, wherein each of the plurality of electrodes is arranged to electrically stimulate at least one of a cavernous nerve of a penis of the patient, arterial blood vessels of the penis of the patient, a corpus spongiosum of the penis of the patient, smooth muscle cells in a corpora cavernosa of the penis of the patient, or ischiocavemosus muscles in a pelvic floor of the patient; controlling an operation of said plurality of electrodes to conduct the plurality of electrical stimulation sessions in accordance with the schedule, wherein each of the plurality of electrical stimulation sessions is applied through at least one of the plurality of electrodes; and transmitting energy to the plurality of electrodes through a wireless network, wherein each of the plurality of electrical stimulation sessions is provided for at least 30 minutes and with an amperage of less than 20 mA.

Optionally, at least some of the plurality of electrical stimulation sessions are controlled remotely by a healthcare professional.

Optionally, at least some of the plurality of electrical stimulation sessions are controlled by the patient through a control device.

Optionally, the plurality of electrical stimulations sessions are continuous.

Optionally, the plurality of electrical stimulations sessions are intermittent and separated by a time period. Optionally, the therapy further comprises pausing an application of the plurality of electrical stimulation sessions for a predefined period of time and resuming the application of the plurality of electrical stimulation sessions after the predefined period of time expires, wherein the predefined period of time is at least one day.

Optionally, the schedule applies each of the plurality of electrical stimulation sessions when the patient is asleep.

Optionally, the therapy further comprises acquiring data related to tumescence during each of the plurality of electrical stimulation sessions and using the data to evaluate a success of the therapy or to re-define the schedule.

Optionally, in a first session, at least one of the cavernous nerve, arterial blood vessels, the corpus spongiosum, or the smooth muscle cells in the corpora cavernosa is stimulated and, in a second session subsequent to, and in series with, the first session, the ischiocavernosus muscles of the pelvic floor area is stimulated.

Optionally, a time gap between the first session and second session is customized based on the patient.

Optionally, in a first series of electrical stimulation sessions, at least one of the cavernous nerve, arterial blood vessels, or the corpus spongiosum, the smooth muscle cells in the corpora cavernosa is stimulated through multiple sessions over a first period of time and, in a second series of electrical stimulations sessions subsequent to, and in series with, the first series of electrical stimulation sessions, the ischiocavernosus muscle of the pelvic floor area is stimulated through multiple sessions over a second period of time.

Optionally, the first period of time is longer than the second period of time.

Optionally, the first period of time is shorter than the second period of time.

Optionally, the therapy includes further prescribing, to the patient, predefined quantities of dietary antioxidants for consumption.

The aforementioned and other embodiments of the present shall be described in greater depth in the drawings and detailed description provided below.

BRIEF DESCRIPTION OF THE DRAWINGS These and other features and advantages of the present specification will be appreciated, as they become better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:

FIG. 1 A illustrates the anatomy of the penis and the mechanics of erectile function;

FIG. IB illustrates partial cross-sectional views of the penis in a flaccid and erect condition;

FIG. 1C illustrates the anatomy of a penis depicting pelvic floor muscles (ischiocavernosus muscles and bulbocavernosus muscles) supporting the base or root of a penis;

FIG. 2A illustrates a block diagram of a system for treatment of erectile dysfunction in accordance with an embodiment of the present specification;

FIG. 2B illustrates a block diagram of a system for treatment of erectile dysfunction in accordance with another embodiment of the present specification;

FIG. 3 illustrates a ring-shaped device in accordance with an embodiment of the present specification;

FIG. 4 illustrates a condom-shaped device in accordance with an embodiment of the present specification;

FIG. 5A illustrates a device comprising a plurality of patches in accordance with an embodiment of the present specification;

FIG. 5B illustrates a patient unit comprising a plurality of electrodes placed along the length of a penis on the dorsal side, in accordance with an embodiment of the present specification;

FIG. 6 is a flowchart depicting a method for treating erectile dysfunction in a patient in accordance with an embodiment; and,

FIG. 7 is a flowchart depicting exemplary steps for remote coordination of stimulation sessions in accordance with an embodiment of the present specification.

DETAILED DESCRIPTION

The present specification is directed towards systems and methods for treating erectile dysfunction including cavernous venous occlusion dysfunction. Erection and the loss of erection are events which are the result of changes in hydraulic pressure due to increased blood flow into the penis and reduced blood flow out of the penis. Clinically, an erection is caused by an increase in blood pressure due to the relaxation of the smooth muscle fibers of the penis, while, conversely, loss of erection is primarily related to the contraction of smooth muscle in the penis. Any reduction in the smooth muscle mass of the corpora cavernosa and the corpus spongiosum impacts erectile quality - a signification reduction in smooth muscle mass leads to complete erectile dysfunction. Weakening of certain PFM (pelvic floor muscles) also impacts the quality of erectile function.

In an embodiment, the present specification discloses a novel system comprising wirelessly controlled contact electrodes that are positioned in contact with the outer surface of the penis and stimulate certain vital portions of the penis which have a significant role in enabling erectile function. The system of the present specification is focused on the regeneration of the smooth muscle through regular electrical stimulation instead of simple blood flow control in prior art systems. In an embodiment, the treatment is intended to improve the production of nitric oxide (nitric oxide synthase) in the body which acts to promote regeneration of the smooth muscle tissues in the penis.

In embodiments, contact electrodes are positioned at locations that stimulate the cavernous nerve, arterial blood vessels, the smooth muscle of the corpora cavernosa within the penis, and/or the smooth muscle of the corpus spongiosum within the penis. In embodiments, the electrodes are also deployed to stimulate and enhance the strength of ischiocavernosus muscles located in the pelvic floor area of the patient.

In embodiments, the system is configured such that the contact electrodes are powered through a control unit that transmits the required power to operate these devices through a wireless network. In another embodiment, the control unit also provides several control functions to the user for operating the system.

In various embodiments of the present specification, a group of contact electrodes is packaged in different shapes and sizes. In an embodiment, the electrodes are configured inside a ring that is worn over the penis and is positioned at the base of the penis. In another embodiment, the electrodes are configured in the form of patches that are attached to the penis at different locations. In another embodiment, the electrodes are embedded in a stretchable cover that may be configured in the shape of a condom, sock or similar structure and can be worn by the user to cover the entire penis or a part of the penis. In embodiments, along with various configurations described above, the ischiocavernosus muscle of the patient is stimulated by deploying patches comprising electrodes in the pelvic floor area of the patient. One of ordinary skill in the art would appreciate that the system comprising the contact electrodes can have multiple configurations with the prime consideration being that vital parts such as the cavernous nerve, arterial blood vessels, the smooth muscle of the corpora cavernosa within the penis, and/or the smooth muscle of the corpus spongiosum within the penis and/or ischiocavernosus muscle of the pelvic floor area are stimulated by such contact electrodes to cause an improvement in erectile function.

In an embodiment, the system comprises a feedback mechanism such that information related to the condition of the penis is communicated to the control unit that can activate, deactivate and control the contact electrodes attached to the penis over the wireless network. In an embodiment, the system comprises a strain gauge or an impedance measurement device (for example to measure a change in dimension, blood flow, or pressure) in order to receive information on nocturnal tumescence. In an embodiment, this information is used for measuring or gauging treatment results or for titrating therapy.

In an embodiment, the control unit is a computing device, comprising a computer readable medium and processor, can be any type of computing and communication device, including a computer, server, mobile smart phone, gateway, laptop, desktop computer, netbook, personal data assistant, remote control device or any other device capable of accessing a cellular, Internet, TCP/IP, Ethernet, Bluetooth, wired, or wireless network.

In an embodiment, the control unit includes a computer software application running on the control unit which enables the user to activate, deactivate and control the contact electrodes coupled to the penis to provide a plurality of stimulation therapies to the patient. In embodiments, where the control unit is a smart phone various additional features such as the option to increase/decrease the degree of stimulation or to preset the timing/frequency/pattern of stimulation are provided to users. In an embodiment, the smart device also stores the information related to results of previous sessions conducted by the system and provides analytical information to evaluate the impact of therapy on the user.

In an embodiment, a treatment application installed on a smart phone (which functions as the control unit) encourages patients to fill out questionnaires on a periodic basis. The information collected via the questionnaires is used to guide users to titrate their therapy accordingly. In another embodiment, the smart phone, via the treatment application, automatically adjusts therapy parameters for a user such as therapy frequency, amplitude or duration or defines therapy-free vacation eligibility for the user.

The wireless controlling of the system is very useful as it allows the user to use the device during intercourse. When wired, there may be embarrassment associated with use of a device. In embodiments, the system is configured such that the electrodes are powered through a control unit that transmits the required power to operate the devices wirelessly. In an embodiment, the electrodes are powered wirelessly and directly without the use of a power storage facility. For example, in embodiments, wireless powering is implemented via, but not limited to, any one of the following technologies: a wireless power transmitter, resonant induction coupling, and radio frequency (RF). Operating the contact electrodes using wirelessly transmitted power is advantageous as otherwise a battery coupled to the contact electrodes would make it bulky and inconvenient to use. In an alternate embodiment, however, power transmission within the system of the present specification is achieved via a small battery pack worn around the waist or strapped to the thigh (or other suitable location) with flexible leads running to the electrodes. In an embodiment, a wireless transmitter may be used to remotely charge the battery pack. In another embodiment, the control unit also provides certain control functions to the user for operating the system.

In embodiments, therapy or treatment using the methods and systems of the present specification is used chronically, such as over several months, to provide long-term electrical stimulation of the cavernous nerve, corpus spongiosum, corpora cavernosa, and arteries/arterioles of the penis (in electrical contact with them) in order to regenerate the smooth muscle mass and/or prevent further degeneration of smooth muscle mass of the penis. In some embodiments, the therapy or treatment also includes stimulating the ischiocavernosus muscle of the pelvic floor area. In some embodiments, the ischiocavernosus muscle is stimulated simultaneously along with the muscles and nerves in the penis. In some other embodiments, the ischiocavernosus muscle of the pelvic floor area is stimulated in a staggered manner, either before or after the stimulation of muscles in the penis. In some embodiments, the muscles in the penis are stimulated through multiple sessions spanning over a period of few days and subsequently, the muscles in the pelvic floor area are stimulated through multiple sessions spanning over a period of few days. In some embodiments, the therapy comprises alternate sessions wherein the muscles/nerves in the penis are stimulated in a first session and subsequently the ischiocavernosus muscles of the pelvic floor area are stimulated in a second session. The time period between the first and second session is customized based on the condition of the patient. In some embodiments, the first session and second sessions are conducted one after the other. In some embodiments, the first session and second session are conducted on alternate days.

In an embodiment, the patient is treated nocturnally via intermittent or continuous electrical stimulation using electrodes on/around the base (or along the length) of the penis, with electrical energy transmitted wirelessly. In an embodiment, electrical energy is transmitted from a pad, such as a mattress pad, over which the patient could sleep on, or a bedside black box (such as small radio or other electronic device) that acts as a wireless energy source to remotely power the electrodes while the patient is asleep or seated on a chair. In another embodiment, the energy is transmitted from a bedside energy transmitter, which also provides the controls to operate the system. In an embodiment, when the stimulation sessions are restricted to nighttime there is less disruption to the patient' s routine.

In an embodiment, the system of the present specification is used as a penile anti-aging device as it can control or curb the degeneration of smooth muscle mass in the erectile bodies of penis and/or the muscle mass in the pelvic floor area. It has been shown that destruction of the cavernous nerve results in very rapid degeneration of penile smooth muscle (probably due to non-availability of nitric oxide). Therefore, enhanced activity of the nerve through stimulation sessions stops the degeneration of smooth muscle mass.

In an embodiment, the long term therapy comprises providing stimulation sessions more than once weekly for more than one week. This may translate into several weeks or months of daytime and/or nighttime intermittent or continuous stimulation. In an embodiment, the stimulation sessions are conducted for at least 30 minutes each time with < 20 mA current in electrodes.

In embodiments, the therapy may be used in conjunction with medications such as PDE5 inhibitors for patients for whom these drugs alone are insufficient (e.g. patients with diabetes do not respond much to PDE5 inhibitors). The system of the present specification can also be used along with a nocturnal tumescence gauge such as RigiScan®. The tumescence strain or pressure gauge may be built into the device to automatically evaluate/titrate results. The therapy is directed at maintaining or improving erectile dysfunction over time by preventing the degeneration of smooth muscle and/or enhancing pelvic floor health through regeneration of new smooth muscle mass. In embodiments, the stimulation sessions are preset by medical personnel such as a physician, physiotherapist, trainer or coach or can also be possibly programmed by the patient. Further, the system allows for appropriate stimulation "vacations" in order to avoid habituation. In another embodiment, the stimulation therapy is increased during a one hour pre- coitus PDE5 inhibitor absorption window.

The present specification is directed towards multiple embodiments. The following disclosure is provided in order to enable a person having ordinary skill in the art to practice the invention. Language used in this specification should not be interpreted as a general disavowal of any one specific embodiment or used to limit the claims beyond the meaning of the terms used therein. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention. In the description and claims of the application, each of the words "comprise" "include" and "have", and forms thereof, are not necessarily limited to members in a list with which the words may be associated.

It should be noted herein that any feature or component described in association with a specific embodiment may be used and implemented with any other embodiment unless clearly indicated otherwise.

FIG. 1A illustrates the anatomy of the penis and the mechanics of erectile function. As shown in FIG. 1A, the penis 100 comprises a shaft 101 which terminates in the glans (head) 102 of the penis. The glans 102 is covered with a moist tissue called mucosa and, in turn, the glans is covered by the foreskin 103 of the penis 100. The shaft 101 comprises three cylindrical columns of tissue that fill with blood when the penis 100 is erect. These three cylindrical chambers of spongy tissue comprise two chambers of corpora cavernosa 104 that run along on the length of the penis on the dorsal side and a single chamber of corpus spongiosum 105 located between the two corpora cavernosa chambers and that runs along the length of the penis on the ventral side. In addition to its sexual function, the penis acts as a conduit for urine to leave the body through via a urethra 106, which runs through the corpus spongiosum 105 and aids in exiting the urine out of the body. The corpora cavernosa 104 and the corpus spongiosum 105 have the most important role in the erectile function of the penis. These chambers are primarily filled with soft tissue comprising smooth muscle fibers and connective tissue, together with sinusoids which fill with blood during the erection. Stimulation of the penile shaft 101 by the nervous system leads to the secretion of nitric oxide (NO), which causes the relaxation of the smooth muscles of the corpora cavernosa 104 (the main erectile tissue of penis), which subsequently causes a penile erection. The veins that provide an exit for blood flow out of the penis are compressed by the blood that fills the corpora cavernosa. Venous compression leads to retention of blood in the sinusoids within the corpora cavernosa which causes an erection.

FIG. IB is a detailed illustration showing partial cross-sections of a penis in both a flaccid and erect state. The partial cross-sectional views show the erectile chamber corpora cavernosa 104 which comprises sinusoids 109 that fill with blood when the penis is erect and veins 107 that provide an outlet for the blood flow out of the penis when the penis changes to a flaccid state from an erect state. The corpora cavernosa 104 also comprises a central artery 108 which facilitates blood flow into the penis. As can be seen from the FIG. IB, in a flaccid condition the sinusoids are not filled with blood and veins 107 are in an unrestricted, open position (larger diameter than when constricted). In a flaccid position, the smooth muscles in the corpora cavernosa 104 do not exert any pressure on the veins 107 and therefore blood can move freely out of the penis. Any stimulation of the penile shaft 101 by the nervous system leads to the secretion of nitric oxide (NO), which causes the relaxation of smooth muscles of corpora cavernosa 104. When in a relaxed position, the smooth muscles exert pressure on the veins 107 which become compressed and block the exit of the flow of blood from the penis. As the blood flow is blocked, the central artery 108 and sinusoids 109 are filled with blood and the chambers of the corpora cavernosa 104 and therefore, the penis become erect. As the smooth muscle expands, the diameter of the central artery 108 also increases which further increases the blood flow into the penis and enhances the level or extent of erection.

Loss of erectile strength is also related to and is a direct effect of the loss of smooth muscle mass. Any reduction in the smooth muscle mass of the corpora cavernosa significantly compromises the ability of these erectile bodies to compress veins and the ability to block the flow of blood from exiting the penis. A sufficient amount of smooth muscle mass is therefore essential for optimal erectile quality.

FIG. 1C illustrates the anatomy of a penis depicting pelvic floor muscles

(ischiocavernosus muscles and bulbocavernosus muscles) supporting the base of a penis. As described in FIG. 1A, the shaft 101 of the penis 100 comprises two corpora cavernosa chambers 104 and a single corpus spongiosum chamber 105. Pelvic floor muscles (PFM) such as ischiocavernosus muscles (IC) 110 and bulbocavernosus muscles (BC) 111 surround the inner aspects of the corpora cavernosa chambers and corpus spongiosum chamber, respectively. These pelvic muscles support the base or root of the penis. When the pelvic muscles contract, they push pressurized blood into the external penis, creating a stiff and rigid erection. The IC muscles 110 surround the inner, deeper portion of the corpora cavernosa chambers and help in maintaining penile erection. In its relaxed state, IC 110 stabilizes the erect penis and compresses the erectile bodies, decreasing the return of blood to push penile blood pressure within a hypertensive range that allows the penis to maintain strong rigidity. The BC 111 surrounds the inner, deeper portion of the urethra and covers and compresses the bulb of the penis. In its relaxed state, it acts as an internal strut that helps anchor the deepest, internal aspect of the penis. During sexual activity, it helps support the corpus spongiosum and glans. At the time of climax, this muscle is responsible for the expulsion of semen by virtue of its strong rhythmic contractions, allowing ejaculation to occur and contributing to orgasm. Loss of strength in the pelvic floor muscles can seriously impact the erectile function. PFM "dysfunction" is a common condition referring to when the PFM are not functioning properly. The PFM can become weakened, flabby and poorly functional due to various factors such as weight gain, a sedentary lifestyle, poor posture, injury, and sexual inactivity which lead to their loss of tone, texture and function. With aging there is a decline in the bulk and contractility of the PFM, often resulting in PFM dysfunction.

Muscular movement is caused by electrical impulses which are transmitted via the nerve cells from the brain to the muscles. These electrical signals are called electromyographic (EMG) signals. Regular activity induced by such EMG signals retains or strengthens the muscle mass. If the muscular mass in any part of the body is reduced, the corresponding organ does not respond well to EMG signals. Inactivity of such muscle tissues further reduces the muscle mass and aggravates the situation by causing muscle atrophy and paralysis. Muscular damage can be prevented through an induced muscle activity. Therefore, in an embodiment of the present specification, external electrically induced stimulation sessions are conducted to protect or even enhance the muscle mass in penis and the pelvic floor area. In an embodiment, the present specification also discloses wearable neuro-stimulation devices that provide stimulation to the cavernous nerve, arterial blood vessels and corpora cavernosa in the penis and/or ischiocavernosus muscles in the pelvic floor area and that also provide therapeutic feedback.

In an embodiment, the present specification discloses a novel system comprising wirelessly controlled contact electrodes that are positioned in contact with the outer surface of the penis and/or pelvic floor area to stimulate certain vital parts which have a role in enabling erectile function of the penis. In embodiments, these contact electrodes are positioned at locations that stimulate the cavernous nerve, arteries/arterioles and/or the smooth muscle of the corpora cavernosa inside the penis. As the smooth muscle tissues in the corpora cavernosa are stimulated, the smooth muscle tissues expand in size and compress the veins coupled to the sinusoids in the corpora cavernosa. Venous compression restricts and eventually blocks the out flow of blood from the penis.

FIG. 2A illustrates a block diagram of the system for treatment of erectile dysfunction in accordance with an embodiment of the present specification. As shown in FIG. 2A, the system 200 comprises a control unit 202 which is in data communication with a patient unit or device 201. In an embodiment, the control unit 202 is a hand held device such as a mobile phone or a tablet which runs or implements a computer application provided with the system 200 to control the operation of the system 200. In another embodiment, the control unit 202 is a separate device (either a stationary device or a mobile device) with processing capabilities which is provided as a part of the system 200. The patient unit 201 comprises a plurality of electrodes 210 which are put in contact with the outer surface of the penis to stimulate the cavernous nerve, arteries/arterioles, corpus spongiosum and/or the smooth muscle of the corpora cavernosa. In some embodiments, the ischiocavernosus muscle of the patient is stimulated by deploying electrodes coupled to the pelvic floor area of the patient. In an embodiment of the present specification, the contact electrodes 210 in the patient unit 201 are powered by transmission of energy from the control unit 201 over a wireless network. In embodiments, the control unit 202 can be any type of computing and/or communication device known to persons of ordinary skill in the art such as, but not limited to, a computer, server, mobile phone, gateway, laptop, desktop computer, netbook, Ultrabook®, personal data assistant, remote control device or any other device capable of accessing a cellular, Internet, Wi-Fi, TCP/IP, Ethernet, Bluetooth, wired, or wireless network. In embodiments, the control unit 202 comprises a computer readable medium and processor.

In embodiments, the electrical stimulation methods and systems of the present specification may be used for achieving a one-off erection prior to intercourse or may be used for providing long-term therapy, which comprises multiple stimulation sessions during the course of the therapy for restoring erectile function over time. In an embodiment, a minimum of one stimulation session at a setting of 3mA lasting greater than or equal to 15 minutes is provided each week over a period of one month. In another embodiment, daily stimulations sessions at a setting of 10mA or more are provided for a minimum of 30 minutes each. Such daily sessions may prove a method for obtaining faster and more effective results. Using daily therapy, some patients were able to obtain a 10% improvement on the International Index of Erectile Function (IIEF) scale, which is a standardized patient questionnaire. In addition, by using daily therapy, some patients were able to see a 10% improvement in penile Doppler ultrasound measurement of cavernosal arterial flow performance (including cavernosa peak systolic velocity measured in a flaccid penis).

In an embodiment the stimulation sessions are continuous and in another embodiment, the stimulation sessions are intermittent. In an embodiment, the stimulation sessions may be preprogrammed. In an embodiment, the system of the present specification may be programmed to allow for appropriate stimulation "vacations" in order to avoid habituation. In embodiments, patients are encouraged to cease obtaining stimulations for periods approximating 25% of the time during which they have received stimulations. For example, after a minimum of one month of stimulation, the patient may cease stimulation for at least one week (which is 25% of one month). Similarly, two weeks of vacation after eight weeks of treatment and three weeks of vacation after 12 weeks of treatment may be advisable.

In an embodiment, the patient unit or device 201 also comprises a corresponding computer application which is capable of receiving instructions transmitted by the control unit 201 and subsequently implementing the instructions. In an embodiment of the present specification, the patient unit 201 comprises a miniature computing unit comprising a processing unit and a memory unit. In some embodiments, the computer application in the control unit 202 is programmed by the user to deliver stimulation therapy automatically in accordance with a predefined schedule. The control unit 202 automatically starts the stimulation session at the pre- defined time(s) and stops such sessions after a pre-defined duration. In embodiments, the level or degree of stimulation is also variable and can be defined by the user.

In an embodiment, the system 200 also comprises a feedback mechanism such that the information related to the condition of the penis may be communicated to the control unit 202 which can activate, deactivate and control the contact electrodes attached to the penis over the wireless network. In an embodiment, the system comprises a strain gauge or an impedance measurement device (for example to measure the dimensional change or blood flow or pressure) in order to receive information on nocturnal tumescence and this information may be used for measuring the treatment results or for titrating the therapy.

In an embodiment, the system 200 is used for preventative purposes wherein the regular stimulation sessions by the system 200 helps slow or curb the degeneration of smooth muscle mass. Men of high risk, such as those showing early stage or low level erectile dysfunction due to age or those with diseases such as diabetes and/or cardiovascular disease may benefit from the use of the system 200 as a preventative means to regularly stimulate the smooth muscle mass of the penis and/or pelvic floor area and maintain the erectile function and quality of the penis.

In another embodiment, the system 200 is used for treating total or high level erectile dysfunction. In this case, regular stimulation sessions in the form of a pre-defined therapy regimen are used to enhance the smooth muscle mass in the penis and/or the pelvic floor area. In embodiments the therapy is designed to be used in conjunction with medications such as PDE5 inhibitors for patients for whom these compounds are insufficient (e.g. patients with diabetes do not respond much to PDE5 inhibitors).

In embodiments of the present specification, patient unit or device 201 may be configured in different shapes and sizes. In an embodiment, the patient unit or device is a simple ring-shaped structure in which the contact electrodes 210 are embedded. In an embodiment, the ring-shaped structure is an expandable stretchable unit that can be worn by the user and positioned near the base of the penis. The contact electrodes 210 in the ring shaped structure are then powered wirelessly by transmission of energy from the control unit 202. In another embodiment, the patient unit or device 201 is in the form of simple patches, comprising contact electrodes, which can be attached or affixed to the penis and/or the pelvic floor area through adhesives or any other such means.

In another embodiment, the electrodes are embedded in a stretchable patient unit or device 201 which may be configured in the shape of a condom and can be worn by the user to cover the entire penis or a part of the penis. One of ordinary skill in the art would appreciate that the system comprising the contact electrodes can have multiple configurations with the prime consideration being that vital parts such as the ischiocavernosus muscles of the pelvic floor area and/or the cavernous nerve, arterial blood vessels, the smooth muscle of the corpora cavernosa within the penis, and/or the smooth muscle of the corpus spongiosum within the penis are stimulated by such contact electrodes to cause an improvement in erectile function.

FIG. 2B illustrates a block diagram of the system for the treatment of erectile dysfunction in accordance with another embodiment of the present specification. As shown in FIG. 2A, the system 200 comprises an external control unit 202 which is in data communication with a patient unit or device 201. The patient unit or device 201 comprises electrodes 210 which are in contact with or electrical communication with the outer skin of the penis to stimulate the cavernous nerve, arteries and the smooth muscle of the corpora cavernosa and/or the pelvic floor area to stimulate the ischiocavernosus muscles. The control unit 202 and the patient unit or device 201 are similar to those described in FIG. 2A. In an embodiment, the system described in the present specification allows healthcare professionals such as physicians, physiotherapists to remotely coordinate the stimulation therapy and evaluate the results of such therapy. In some embodiments, the system 200 comprises a remote network such as a cloud network 203 on which the information recorded by the control unit is stored. The physician or clinician, through another device such as a mobile unit 204, can operate the control unit 202 through the cloud network 203. All information recorded by the control unit 202 is stored on the cloud network 203 such that the physician can see such information through his device 204 to monitor the impact of the therapy and can modify the schedule of the therapy if required. In another embodiment, the mobile unit 204 communicates directly with the control unit 202 and there is no cloud network in the system 200.

FIG. 3 illustrates a ring shaped patient unit or device in accordance with an embodiment of the present specification. As shown in FIG. 3, the ring shaped patient unit 300 comprises an outer surface 301 and an inner surface 302. The patient unit 300 is a wearable system such that the patient can slide it over the penis until it reaches the base of the penis. In embodiments, the ring shaped unit 300 is stretchable and expandable and when worn, takes the shape of the outer surface of the penis. The stretchable structure of the unit 300 also accommodates the change in size of the penis from a flaccid condition to an erect condition. The patient unit 300 comprises a plurality of contact electrodes 310 coupled to its inner surface 302 such that when the patient unit 300 is worn by the patient the contact electrodes 310 establish a contact with the outer surface of the penis. In an embodiment, the patient unit 300 comprises a Velcro band with electrodes embedded within the band so that adjustments for size can easily be made when the band is worn around the patient's penis. The number and exact position of contact electrodes can vary in embodiments of the present specification.

The ring shaped unit 300 also comprises a system to communicate with an external control unit. In an embodiment, the external control unit is a device (either mobile or stationary) which is used only for controlling the patient unit 300 and is provided along with the system. In another embodiment, the external control unit is a hand held unit such as a mobile phone or a tablet which is configured with a computer application provided with the system that can establish a communication link with the patient unit 300. In an embodiment, the ring shaped unit 300 comprises a miniature computing device embedded in it which can take instructions from the external wireless unit and allow the stimulation sessions to be controlled by the wireless unit.

In an embodiment, when the stimulation session is started, the contact electrodes 310 stimulate vital parts such as the cavernous nerve, arteries/arterioles and the smooth muscle of the corpora cavernosa. On stimulation, the smooth muscle cells expand and blocks the blood flow out of the penis which causes erection.

In an embodiment, the contact electrodes 310 in the ring shaped structure are powered wirelessly by transmission of energy from the external control unit.

FIG. 4 illustrates a condom shaped patient unit in accordance with an embodiment of the present specification. As shown in FIG. 4, the condom shaped patient unit 400 comprises a proximal portion 401b and a distal portion 401a. The distal portion 401a is closed and covers the glans of the penis and the proximal portion 401b comprises an opening through which the patient can wear the unit 400 over the penis shaft. In embodiments of the present specification, the length of the unit 400 varies such that it may cover the entire length or a portion of the penis shaft. In embodiments, the condom shaped unit 400 is stretchable and when worn, it takes the shape of the outer surface of the penis. The patient unit 400 comprises a plurality of contact electrodes 410 on its inner surface such that such that when the unit 400 is worn by the patient the contact electrodes 410 establish a contact with the outer surface of the penis. The number and exact position of contact electrodes can vary in embodiments of the present specification. In an embodiment, the contact electrodes 410 are powered wirelessly by transmission of energy from an external control unit.

FIG. 5A illustrates a patient unit comprising a plurality of patches in accordance with an embodiment of the present specification. As shown in FIG. 5A, the patient unit 500 comprises a plurality of patches 501 which can be attached to the outer portion of the penis and/or the pelvic floor area to target the ischiocavernosus muscles. In embodiments of the present specification, the number of patches in a patient unit can vary.

In embodiments, the patches 501 can be attached through an adhesive that is already present on the inner side of the patch 501. Each patch 501 patient comprises one or more contact electrodes 510 such that as the patch 501 is attached to the penis, the contact electrode 510 in the patch establishes a contact with the outer surface of the penis. Subsequently, as the stimulation session is started with the help of an external control unit, the contact electrodes 510 stimulates the vital parts such as the cavernous nerve, arteries/arterioles and the smooth muscle of the corpora cavernosa. On stimulation, the smooth muscle cells expand and blocks the blood flow out of the penis which causes erection. In embodiments, one or more patches 510 are deployed over the pelvic area of the patient to stimulate the ischiocavernosus muscles. Regular stimulation sessions increase the strength of the ischiocavernosus muscles and enhance the capability of the penis to sustain erection. In an embodiment, the contact electrodes 510 are powered wirelessly by transmission of energy from the external control unit. The wireless energy transmission to the device also allows the user to use the device during intercourse and avoid the embarrassment of having to deal with wires.

In an embodiment, electrode patches are placed on the dorsal aspect of the penis, along the longitudinal length of the penis. FIG. 5B illustrates a patient unit comprising a plurality of electrodes placed along the length of a penis on the dorsal side, in accordance with an embodiment of the present specification. As shown in FIG. 5B, the patient unit comprises a plurality of electrodes 510 placed on a dorsal aspect 515 and along the longitudinal length of the penis 520. In another embodiment, the electrodes may be placed similarly (on the dorsal aspect) along the length of the penis 520 on the ventral side.

In an embodiment, the patient unit is configured in the form of an implantable miniaturized device placed on the portion of the penis and/or the pelvic floor area which is embedded inside the body. The implantable device receives energy wirelessly through an external control unit. The advantage of this approach is that as the device is out of the sight of the patient thus removing any mental pressure or association for the patient. Further, it is convenient to use as the patient does not have to wear the electrode system every time for therapeutic stimulation sessions or for the sexual activity. In an embodiment, the device can be delivered to the penis through interventional operation. In an embodiment, the device is delivered through a needle.

FIG. 6 is a flow chart depicting a method for treating erectile dysfunction in a patient in accordance with an embodiment. At step 602, a plurality of electrodes are provided to stimulate at least one of the cavernous nerve, arterial blood vessels, the corpus spongiosum, the smooth muscle cells in the corpora cavernosa of a penis, and ischiocavernosus muscles of the pelvic floor area of the patient. In various embodiments, the electrodes are provided in a plurality of wearable forms such as, but not limited to, those described with reference to Figs. 3, 4 and 5 above, so that the electrodes can be placed in contact with predefined portions of the penis of the patient. At step 604 the electrodes are energized periodically based on a predetermined therapy protocol, for providing electrical stimulation, where the energizing current and stimulation periods are controlled remotely.

FIG. 7 illustrates a flowchart depicting the exemplary steps for remote coordination of stimulation sessions in accordance with an embodiment. As shown in FIG. 7, at step 701, the healthcare professional such as a physician creates a schedule for the stimulation sessions as a part of a long-term therapy. In an embodiment, the physician defines the schedules through a remote device such as the device 204 shown in FIG. 2B. The schedule defined by the physician is accessible to the patient or an attendance through the control unit such as the mobile phone of patient (device 202 shown in FIG. 2B). At step 702, the mobile application installed in the mobile phone of the patient automatically checks the stimulation session schedule and in case there is an impending stimulation session, the mobile application triggers a reminder for the patient. At step 703, the patient wears the electrode system such as the patient unit shown in FIG. 2B and switches on the stimulation session from the mobile phone. In another embodiment, the device is configured such that the session automatically start based on the instructions received from the remote device of patient and the patient has to just wear the electrode system. In an embodiment, at step 704, the stimulation session is conducted for a predefined duration with a predefined current in the electrodes. In an embodiment, the stimulation sessions are conducted for a minimum of half an hour and with a minimum electrode current of 20 raA. In an embodiment, the sessions are continuous and in another embodiment, the sessions are intermittent. At step 705, information from the feedback device such as an impedance measurement device or strain gauge is received by the mobile phone of the patient and further transmitted to the physician. At step 706, the physician reviews the feedback information to evaluate the success of the therapy and if required, may modify the schedule.

As is known, common causes of ED include arterial insufficiency and veno-occlusive dysfunction in the penis. The system and therapeutic method of the present specification addresses both of these causes as electrical stimulation improves arterial blood flow in the penis and also regenerates cavernous smooth muscle over time, which, in turn, improves venous blood retention by better occluding vessels and inhibiting leakage. Further both arterial insufficiency and veno-occlusive dysfunction in the penis can be indirectly measured using penile Doppler ultrasound, which is used to image blood flow in and out of the penis. An improvement in the patient undergoing the electrical stimulations therapy may be determined by comparing scores of the patient on the International Index of Erectile Function (IIEF) scale before and after the treatment.

Patients suffering from ED usually do not respond to sildenafil citrate (Viagra®) and/or other phosphodiesterase (PDE) inhibitors. It has been observed that patients undergoing the electrical stimulation therapy of the present specification typically begin responding to PDE inhibitors, such as but not limited to Viagra®. For example, a patient receiving said electrical stimulations daily for 30 days and who was non -responsive to lOOmg of Viagra® prior to commencement of the stimulation therapy, may become responsive to said dosage of Viagra®. Further, the stimulation therapy may make a patient who is only responsive to lOOmg of Viagra® (but not to 50mg) become responsive to 50mg of Viagra®. Therefore, with the improvement in penile functionality using the electrical stimulation of the present specification, a patient may be able to use therapies that were not otherwise effective or available to the patient. The use of dietary antioxidants improve intracavernosal blood flow, erectile activity, and promotes smooth muscle relaxation. In an embodiment, a patient suffering from ED is treated with electrical stimulations as described above along with consumption of dietary antioxidants, (such as but not limited to, pomegranate juice or blueberry extract). The improvement in patient condition can be measured via the patient's response to IIEF questionnaires, penile Doppler ultrasound, or increased responsiveness to PDE inhibitors such as sildenafil citrate. A smart phone may be used for controlling, monitoring and titrating the patient's therapy parameters based on the measured improvement. In another embodiment, the smart phone adjusts therapy parameters for a user such as therapy frequency, amplitude or duration and/or defines therapy- free vacation eligibility for the user by using the patient's response to IIEF questionnaires, penile Doppler ultrasound, or increased responsiveness to PDE inhibitors such as sildenafil citrate as feedback.

The above examples are merely illustrative of the many applications of the system of present invention. Although only a few embodiments of the present invention have been described herein, it should be understood that the present invention might be embodied in many other specific forms without departing from the spirit or scope of the invention. Therefore, the present examples and embodiments are to be considered as illustrative and not restrictive, and the invention may be modified within the scope of the appended claims.

Claims

CLAIMS We claim:

1. A system for treating erectile dysfunction in a patient, comprising:

a plurality of electrodes arranged to deliver electrical stimulation to at least one of a cavernous nerve of a penis of the patient, arterial blood vessels of the penis of the patient, a corpus spongiosum of the penis of the patient, or smooth muscle cells in a corpora cavernosa of the penis of the patient by direct physical contact with an outer skin surface of the penis; and

a control unit in electrical communication with the plurality of electrodes and configured to control an operation of said plurality of electrodes by providing energy to one or more of the plurality of electrodes to generate said electrical stimulation, wherein the electrical stimulation is provided for at least 30 minutes in a single treatment session and wherein an amperage of the electrical stimulation is less than 20 mA.

2. The system of claim 1 wherein the control unit is configured to deliver energy to the plurality of electrodes through wireless transmission.

3. The system of claim 2 wherein the control unit is configured to power the plurality of electrodes using at least one of a wireless power transmitter, a resonant induction coupling method, or a radio frequency (RF) transmitter.

4. The system of claim 1, wherein the plurality of electrodes are coupled to a ring-shaped device configured to be worn over the penis.

5. The system of claim 4, wherein said ring-shaped device is configured to be stretchable and expandable.

6. The system of claim 1, further comprising an adjustable band, wherein said plurality of electrodes are embedded in the adjustable band which is configured to be worn over the penis.

7. The system of claim 6, wherein the adjustable band comprises Velcro.

8. The system of claim 1, wherein the plurality of electrodes are coupled to a condom-shaped wearable sheath configured to be worn over the penis.

9. The system of claim 1, wherein the plurality of electrodes are coupled to individual, adhesive patches which are configured to be attached to the outer skin surface of the penis.

10. The system of claim 1, wherein the electrical stimulation is configured such that, upon delivering the electrical stimulation, smooth muscle cells in the corpora cavernosa relax and thereby compress veins to stop an outflow of blood leading to penis erection.

11. The system of claim 1, wherein the electrical stimulation is configured such that, upon delivering the electrical stimulation, degeneration of smooth muscle mass in the penis is prevented and erectile quality is maintained.

12. The system of claim 1, wherein the electrical stimulation is configured such that, upon delivering the electrical stimulation, regeneration of smooth muscle mass in the penis is achieved and erectile quality is enhanced.

13. The system of claim 1, wherein the electrical stimulation comprises a current of 3mA and wherein the control unit is configured to apply the electrical stimulation for a period of time lasting at least 15 minutes and at least once per week over a period of one month.

14. The system of claim 1, wherein the control unit is configured to apply the electrical stimulation daily for a minimum of 30 minutes and with a current of at least 10mA.

15. The system of claim 1, wherein the control unit is configured to apply the electrical stimulation over a period of at least one month and over more than one session, wherein each of the more than one sessions has a pre-defined duration.

16. The system of claim 15, wherein the control unit is configured to apply the more than one session while the patient is asleep.

17. The system of claim 1, wherein the control unit is configured to be manually controlled by the patient through at least one of an activation of one of the plurality of electrodes, a deactivation of one of the plurality of electrodes, or a changing a level of electrical stimulation.

18. The system of claim 1, wherein said control unit is a hand held device, which comprises programmatic instructions configured to control an operation of the control unit.

19. The system of claim 18, wherein said control unit provides a visual or auditory interface to guide the patient on how to titrate electrical stimulation based on an input from the patient.

20. The system of claim 19, wherein said control unit is configured to automatically adjust electrical stimulation parameters, wherein the electrical stimulation parameters comprises at least one of an electrical stimulation frequency, an electrical stimulation amplitude, an electrical stimulation duration, or an electrical stimulation vacation eligibility.

21. The system of claim 1, further comprising an impedance measurement device or a strain gauge wherein the impedance measurement device or the strain gauge is coupled to the penis to record an effect of the electrical stimulation.

22. The system of claim 21, wherein the impedance measurement device or the strain gauge is configured to measure changes in a dimension of the penis.

23. The system of claim 21, wherein the impedance measurement device or the strain gauge is configured to detect tumescence by measuring changes in blood pressure and flow rate in the penis.

24. The system of claim 22, wherein the control unit is configured to receive data from the impedance device and analyze the data to determine a success level of the electrical stimulation.

25. A therapy for treating erectile dysfunction in a patient, comprising:

defining a schedule for applying a plurality of electrical stimulation sessions to a penis of the patient;

placing a plurality of electrodes on an outer skin surface of the penis or the pelvic floor of the patient, wherein each of the plurality of electrodes is arranged to electrically stimulate at least one of a cavernous nerve of a penis of the patient, arterial blood vessels of the penis of the patient, a corpus spongiosum of the penis of the patient, smooth muscle cells in a corpora cavernosa of the penis of the patient, or ischiocavernosus muscles in a pelvic floor of the patient;

controlling an operation of said plurality of electrodes to conduct the plurality of electrical stimulation sessions in accordance with the schedule, wherein each of the plurality of electrical stimulation sessions is applied through at least one of the plurality of electrodes; and

transmitting energy to the plurality of electrodes through a wireless network, wherein each of the plurality of electrical stimulation sessions is provided for at least 30 minutes and with an amperage of less than 20 mA

26. The therapy of claim 25, wherein at least some of the plurality of electrical stimulation sessions are controlled remotely by a healthcare professional.

27. The therapy of claim 25, wherein at least some of the plurality of electrical stimulation sessions are controlled by the patient through a control device.

28. The therapy of claim 25, wherein the plurality of electrical stimulations sessions are continuous.

29. The therapy of claim 25, wherein the plurality of electrical stimulations sessions are intermittent and separated by a time period.

30. The therapy of claim 25 further comprising pausing an application of the plurality of electrical stimulation sessions for a predefined period of time and resuming the application of the plurality of electrical stimulation sessions after the predefined period of time expires, wherein the predefined period of time is at least one day.

31. The therapy of claim 25, wherein the schedule applies each of the plurality of electrical stimulation sessions when the patient is asleep.

32. The therapy of claim 25, further comprising acquiring data related to tumescence during each of the plurality of electrical stimulation sessions and using the data to evaluate a success of the therapy or to re-define the schedule.

33. The therapy of claim 25, wherein, in a first session, at least one of the cavernous nerve, arterial blood vessels, the corpus spongiosum, or the smooth muscle cells in the corpora cavernosa is stimulated and, in a second session subsequent to, and in series with, the first session, the ischiocavernosus muscles of the pelvic floor area is stimulated.

34. The therapy of claim 33, wherein a time gap between the first session and second session is customized based on the patient.

35. The therapy of claim 25, wherein, in a first series of electrical stimulation sessions, at least one of the cavernous nerve, arterial blood vessels, or the corpus spongiosum, the smooth muscle cells in the corpora cavernosa is stimulated through multiple sessions over a first period of time and, in a second series of electrical stimulations sessions subsequent to, and in series with, the first series of electrical stimulation sessions, the ischiocavernosus muscle of the pelvic floor area is stimulated through multiple sessions over a second period of time.

36. The therapy of claim 35, wherein the first period of time is longer than the second period of time.

37. The therapy of claim 35, wherein the first period of time is shorter than the second period of time.

38. The therapy of claim 25 further prescribing, to the patient, predefined quantities of dietary antioxidants for consumption.