Patent Publication Number: US-8529432-B1

Title: Penile implant for aiding achievement of a penile erection

Description:
TECHNICAL FIELD 
     The present invention, in some embodiments thereof, relates to the field of medical devices, and more specifically to medical devices for helping male subjects who experience erectile dysfunction achieve erection. 
     BACKGROUND OF THE INVENTION 
     Erectile dysfunction (ED) is sexual dysfunction characterized by the inability to develop or maintain firmness of the penis (an erection) during sexual performance. 
     A penile erection is the hydraulic effect of blood entering and being retained in sponge-like bodies within the penis. The process is often initiated as a result of sexual arousal, when signals are transmitted from the brain to nerves in the penis. Erectile dysfunction is indicated when an erection is difficult to produce. Endocrine, psychogenic, vascular, traumatic or iatrogenic origins are example of underlying causes of erectile dysfunction. 
     Erectile dysfunction is generally treated or managed via medication, external devices (e.g., penis pumps), or surgical implants. Surgical implants may be semi-rigid devices or inflatable devices. Semi-rigid devices range from permanently erect ones that cannot be altered to malleable ones that can be bent into position where appropriate. Some of the known implants consist of a pair of malleable rods surgically implanted within the erection chambers of the penis. With this type of implant the penis is always semi-rigid and merely needs to be lifted or adjusted into the desired position. Hydraulic, inflatable prosthesis also exist. These use fluid and are inflated or deflated on demand. Both inflatable and non-inflatable implants are implanted deep inside of penis corpus carvenosa. 
     BRIEF SUMMARY OF EMBODIMENTS OF THE INVENTION 
     Some semi-rigid devices generally keep the penis in a constant semi-rigid mode, even when erection is not required or desirable. Thus, semi-rigid devices may cause discomfort to the patient. Inflatable devices generally need to be filled with a fluid from an external source, in order to cause an erection. Moreover, the state-of-the-art implants (particularly the inflatable ones) are known to compress penile inner tissue and vasculature, resulting in atrophy and disfigurement of penis in significant proportion. Use of inflatable implants tends to diminish the likelihood of natural erection. Thus, a novel surgically implanted device is needed in the art. 
     The present invention aims to provide means assist a patient to maintain vaginal penetration during the course of intercourse and optionally to evoke natural erection, while incurring minimal surgical invasion to penis. A device of the present invention comprises at least two elongated rods which are configured for glide in and out penis shaft though lubricated sleeves implanted subcutaneously between deep and superficial penile fascia or just over the superficial fascia in each side. The rods are joined to an interconnecting structure which is joined to the rods to each other and stabilizes the rods within the penis shaft. When not deployed in the shaft, the rods may be retracted into the suprapubic or perineal region. 
     When moved into the penis shaft, the rods enable artificial erection and help preserve the firmness needed to perform and maintain vaginal penetration. In this manner, the patient can experience vaginal stimulation and obtain firm natural erection. The device of the present invention may also enable maintaining penetration after ejaculation. When maintaining the erection is no longer required, the rods are retracted from the penis shaft, enabling the penis to return to its flaccid state. 
     Because the rods are retractable, the device of the present invention enables attaining erection only when needed, without a need for external fluids to be inserted into the patient&#39;s body every time the device is to be used. Moreover, thanks to its size and structure, the device of the present invention causes minimal injury and invasion of penile tissue, and does not hinder the achievement of natural erection. 
     Thus, an aspect of some embodiments of the present invention relates to an implant for helping a male patient achieve a penile erection, the implant comprising a pair of substantially straight and substantially rigid rods and an interconnecting structure. The rods are configured for being implanted subcutaneously in the patient and are selectively movable from a retracted mode of the implant to a deployed mode of the implant. In the deployed mode the rods are within the penis shaft, while in the retracted mode at least a majority of each rod is out of the penis shaft. The interconnecting structure is implanted subcutaneously in the patient and joined to the rods, and is configured for stabilizing the rods within the penis shaft. 
     The interconnecting structure is may be configured for moving with the rods or for being substantially static. 
     In some embodiments of the present invention, device is provided for helping a male patient achieve a penile erection. The device comprises the above-described implant and a sealed, hollow, flexible sheath. The implant is in the form of a rod unit which comprises the rods and a substantially rigid curved section having a first and a second end, the curved section forming the interconnecting device and each rod being joined to a respective end of the curved section and extending away from the curved section at non-zero angle with a plane which includes the curved section. The rods extend away from the curved section in the same direction. The sheath is configured for enclosing the rod unit, and comprises a body portion, and two thin elongated legs extending away from one side the body portion. The body portion is configured for enclosing at least a majority of the rod unit when the rod unit is retracted within the body portion, and the legs are configured for enclosing the rods when the rod unit is deployed out of the body portion. The rod unit is selectively movable from a retracted mode thereof to a deployed mode thereof, where in the retracted mode at least a majority of the rod unit is within the sheath&#39;s body part, and in the deployed mode the rods are enclosed in the respective legs of the sheath. 
     Optionally, the body portion is configured for being subcutaneously implanted in the patient&#39;s pubic region above the patient&#39;s penis, and the legs are configured for being implanted along sides of a shaft of the patient&#39;s penis below a skin of the penis and above a deep or superficial fascia of the penis. The rod unit is selectively movable from the retracted mode thereof to the deployed mode thereof, where in the retracted mode the rod unit does not extend along the penis shaft, and in the deployed mode the curved section holds a base of the penis and stabilizes the rods while the rods are enclosed in the respective legs of the sheath and thus provide rigidity of the penis shaft. 
     In a variant, the non-zero angle between rods and the plane which includes the curved section is between about 60 degrees and 120 degrees. 
     In another variant, the curved section is somewhat flexible. 
     In yet another variant, the sheath comprises and encloses lubricant material. 
     In a further variant, the above device comprises at least one loop joined to an outer surface of at least one leg of the sheath. 
     In an additional variant, the curved section of the rod is configured for being located in a vicinity of a suspensory ligament of the penis, when the rod unit is in the deployed mode. 
     According to some embodiments of the present invention, the above device further comprises a hollow reservoir, a conduit, and perforated enclosure. The hollow reservoir is configured for being implanted in the patient&#39;s body, and for receiving and holding a fluid. The conduit has a first end in fluid communication with the hollow reservoir, and a second end. The perforated enclosure is joined to an outer surface of at least one leg and extends along a length of the at least one leg. The perforated enclosure is in fluid communication with the conduit&#39;s second end and has at least one opening configured for releasing the fluid delivered to the perforated enclosure from the reservoir via the conduit into the patient&#39;s body. 
     Optionally, the above device comprises a valve at a junction between the reservoir and the conduit, the valve being configured for enabling the fluid&#39;s flow from the reservoir to the conduit, when at least a predetermined pressure is exerted on the reservoir. 
     In a variant, the rod unit comprises two sections removably joinable to each other, the first section comprising a first portion of the curved section and a first one of the rods and the second section comprising a second portion of the curved section and a second one of the rods, such that the first portion of the curved section is removably joinable to the second portion of the curved section. 
     In another variant, the rod unit comprises plurality of rods substantially parallel to each other and joined to the curved section. 
     Optionally, the sheath comprises a plurality of legs, each leg being configured for enclosing a respective one of the rods. 
     According to some embodiments of the present invention, there is provided a device for being implanted in a body of the patient and for helping a male patient achieve a penile erection. The device includes the above-mentioned implant and two sealed flexible sleeves. The implant comprises the pair of rods, and the interconnecting structure comprises a curved base frame and two tubes. The curved base frame is substantially rigid and has two ends. Each tube is joined to the curved base frame near a respective end of the curved base frame, and extends away from the curved base frame, the tubes being at a non-zero angle with a plane which includes the curved base frame. Each tube is traversed by a respective one of the flexible sleeves. Each sleeve encloses a respective one of the rods. Each rod is selectively movable within the respective sleeve between a rear side of the curved base frame and a front side of the curved base frame. 
     Optionally, the curved base frame is configured for being implanted in a pubic region in a vicinity of a base of a penis of the patient, to encircle a portion a base of a penis of the patient, and for being implanted below a skin of the penis and above or within or below a suspensory ligament of the penis. Each tube is implanted below the skin in a vicinity of the penis base. The first portion of each sleeve on the rear side of the curved base frame is configured for being implanted along a root of the penis or below a skin on a pubic area of the patient. The second portion of each sleeve on the front side of the curved base frame is configured for being implanted along a shaft of the patient&#39;s penis. Each rod is selectively movable within the sleeve between the rear side of the curved base frame and the front side of the curved base frame, such that the rods provide rigidity to the penis shaft when located in the second portions of the respective sleeves. 
     In a variant, the curved base frame is somewhat flexible. 
     In another variant, at least one of the sleeves comprises and encloses lubricant material. 
     In yet another variant, the device includes at least one loop joined to an outer surface of at least sleeve on the front side of the curved base frame. 
     In a further variant, the device further comprises a hollow reservoir, a conduit, and a perforated enclosure. The hollow reservoir is configured for being implanted in the patient&#39;s body and for receiving and holding a fluid. The conduit has a first end in fluid communication with the hollow reservoir, and a second end. The perforated enclosure is joined to an outer surface of at least one sleeve and extending along at least part of a length of the at least one sleeve, the perforated enclosure being in fluid communication with the conduit&#39;s second end and having at least one opening configured for releasing the fluid delivered to the perforated enclosure from the reservoir via the conduit into the patient&#39;s body. 
     Optionally, the device comprises a valve at a junction between the reservoir and the conduit, the valve being configured for enabling the fluid&#39;s flow from the reservoir to the conduit, when at least a predetermined pressure is exerted on the reservoir. 
     In a variant, the device comprises: a plurality of tubes joined to the curved base frame; a plurality of sleeves, each traversing a respective tube; and a plurality of rod, each enclosed within a respective sleeve. 
     Other features and aspects of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the features in accordance with embodiments of the invention. The summary is not intended to limit the scope of the invention, which is defined solely by the claims attached hereto. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention, in accordance with one or more various embodiments, is described in detail with reference to the following figures. The drawings are provided for purposes of illustration only and merely depict typical or example embodiments of the invention. These drawings are provided to facilitate the reader&#39;s understanding of the invention and shall not be considered limiting of the breadth, scope, or applicability of the invention. It should be noted that for clarity and ease of illustration these drawings are not necessarily made to scale. 
       Some of the figures included herein illustrate various embodiments of the invention from different viewing angles. Although the accompanying descriptive text may refer to such views as “top,” “bottom” or “side” views, such references are merely descriptive and do not imply or require that the invention be implemented or used in a particular spatial orientation unless explicitly stated otherwise. 
         FIGS. 1   a  and  1   b  are schematic drawings illustrating a device of the present invention, in its deployed mode and retracted mode; 
         FIGS. 2 and 3  are schematic drawings illustrating an embodiment of the present invention, in which the device of the present invention includes a rod unit which may be movable within a sheath; 
         FIGS. 4 ,  5   a , and  5   b  are schematic drawings illustrating the use of the device of  FIGS. 2 and 3  when implanted within a patient; 
         FIG. 6  is a perspective drawing illustrating a cutout of a penis in which the device of  FIGS. 2 and 3  is implanted; 
         FIG. 7  is a schematic drawing illustrating an embodiment of the present invention in which a perforated enclosure is joined to an outer surface of at least one of the legs of the sheath; 
         FIGS. 8 ,  9   a  and  9   b  are a drawings illustrating an embodiment of the present invention in which the rod unit includes two sections which are removably joinable to each other; 
         FIG. 10  is a perspective drawing illustrating an embodiment of the present invention in which the rod unit includes a plurality of rods; 
         FIG. 11  is a perspective drawing illustrating a device of the present invention which includes a curved base frame joined to at least two hollow tubes in the vicinity of the curved base frame&#39;s ends, each tube holding a sealed sleeve enclosing a rod which can be moved within the sleeve; 
         FIG. 12  is a detail drawing of an assembly formed by a tube, a sleeve, and rod in the device of  FIG. 11 ; 
         FIGS. 13 and 14  illustrate a use of the device of  FIG. 11 , in which one side of the sleeve is implanted in the root section of the penis while another side of the sleeve is implanted in the shaft of the penis; 
         FIGS. 15 and 16  illustrate a use of the device of  FIG. 11 , in which one side of the sleeve is implanted in the pubic region while another side of the sleeve is implanted in the shaft of the penis; 
         FIG. 17  is a schematic drawing illustrating an embodiment of the present invention, in which the device of  FIG. 11  includes a perforated enclosure joined to an outer surface of the portion of the sleeve implanted in the penis shaft and/or a plurality of loops joined to an outer surface of the portion of the sleeve implanted in the penis shaft; and 
         FIG. 18  is a schematic drawing illustrating an embodiment of the present invention, in which the device of  FIG. 11  includes at least three rods. 
     
    
    
     The figures are not intended to be exhaustive or to limit the invention to the precise form disclosed. It should be understood that the invention can be practiced with modification and alteration, and that the invention be limited only by the claims and the equivalents thereof. 
     DETAILED DESCRIPTION OF THE EMBODIMENTS OF THE INVENTION 
     From time-to-time, the present invention is described herein in terms of example environments. Description in terms of these environments is provided to allow the various features and embodiments of the invention to be portrayed in the context of an exemplary application. After reading this description, it will become apparent to one of ordinary skill in the art how the invention can be implemented in different and alternative environments. 
     Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which this invention belongs. All patents, applications, published applications and other publications referred to herein are incorporated by reference in their entirety. If a definition set forth in this section is contrary to or otherwise inconsistent with a definition set forth in applications, published applications and other publications that are herein incorporated by reference, the definition set forth in this document prevails over the definition that is incorporated herein by reference. 
     Referring now to the drawings,  FIGS. 1   a  and  1   b  are schematic drawings illustrating a device  10  of the present invention, in its deployed mode ( FIG. 1   a ) and retracted mode ( FIG. 1   b ). 
     The device  10  of the present invention includes a first rod  12 , a second rod  14 , and an interconnecting structure  16 . The rods  12  and  14  and the interconnecting structure  16  are configured for being implanted subcutaneously in a patient. In the device&#39;s deployed mode, the rods  12  and  14  are located in the penis shaft  202  under the skin  202   a  and provide rigidity to the penis during sexual intercourse. In the device&#39;s retracted mode, the rods  12  and  14  are retracted away from the penis shaft, and allow the penis to return to its flaccid state. When not deployed in the shaft, the rods may be retracted into the suprapubic or perineal region. 
     The interconnecting structure  16  is joined to the rods and stabilizes the rods within the penis shaft. The interconnecting structure may move with the rods, or may be substantially static while the rods move into and away from the penis shaft. 
       FIGS. 2 to 10  exemplify some embodiments of the present invention in which the interconnecting structure moves with the rods.  FIGS. 11 to 18  exemplify some embodiments of the present invention in which the interconnecting structure substantially does not move with the rods. 
     Referring now to  FIGS. 2 and 3 , schematic drawings illustrate an embodiment of the present invention, in which a device  100  of the present invention includes a rod unit  102  which may be movable within a sheath  104 . The device  100  is configured for being surgically implanted into a patient&#39;s body, and is configured to be manipulated by the patient, in order for the patient to achieve an erection. 
     The rod unit  102  includes a curved section  106  and two substantially straight rods  108  and  110 . The rod unit  102  is an example of the device  10  of  FIGS. 1   a  and  1   b . The rods  108  and  110  correspond to the rods  10  and  12  of the device  10 , whiles the curved section  106  is an example of interconnecting structure  16  of the device  10 . 
     The curved section has two ends and is therefore not a loop. The rods  108  and  110  are joined to respective ends of the curved section  106 . The rods  108  and  110  extend away from the curved section  106  and are at non-zero an angle β with a plane which includes the curved section  106 . The rods  108  and  110  extend away from the curved section  106  in the same direction. In some embodiments of the present invention, the angle β is between 60° and 120°. The curved section  106  has an open shape, as it is designed to surround a section of the base of the penis which does not include the ventral section on the penis&#39;s base. The curved section  106  may be shaped like a portion of a circle, for example like a semicircle. 
     The rod unit  102  may be cast as a single unit, or may be made of different units joined to each other by a locking mechanism (screw, adhesive, press-fit, etc.). The presence of the curved section and its linking to the rods limit the motion of the rods with respect to each other. Thus the curved section stabilizes the position and orientation of the rods with respect to each other and the penis. The rods are substantially rigid, as they are meant to impart rigidity to the penis to enable the penis to sustain vaginal penetration, when the rods are located along sides of the penis&#39;s shaft. Optionally, curved section  106  is rigid, yet flexible. This enables a user (patient) to bend the curved section  106 , in order to adjust the strength of the hold of the curved section  106  onto the base of the penis. The strength of the curved section&#39;s hold on the base of the penis may be increased by pushing the curved section inwards and thus tightening the curve. The strength of the curved section&#39;s hold on the base of the penis may be decreased by pulling the ends of the curved section outwards and thus stretching the curve. The latter may be performed in order to accommodate and penis that is enlarged during erection. 
     In a variant, the curved section  106  and the rods  108  and  110  are made of substantially rigid or copper with or without some tensile quality. In another variant, the curved section  106  and the rods  108  and  110  are made of a polymer plastic material. Rigid or semi-rigid flexible plastic material produced by mold extrusion, may be a fitting example, since this kind of plastic material can be manufactured to be durable and biocompatible. In yet another variant, the curved section  106  and the rods  108  and  110  are made of plastic-encased copper. 
     The sheath  104  is a hollow, closed (sealed) element configured for enclosing the rod unit  102 . The sheath  104  includes body portion  112  and two thin elongated legs  114  and  116  extending away from one side of the body portion. The sheath  104  is configured for being implanted subcutaneously in the patient&#39;s genital region, such that the body portion  112  is in the pubic region and legs  114  and  116  extend along each side of penis shaft underneath the skin. The legs  114  and  116  may be implanted either between the deep fascia and the superficial fascia, or above the superficial fascia and under the skin. The sheath  104  is flexible (elastic) and soft, while being durable. The body portion  112  is configured for being implanted in the pubic region of the patient, above the patient&#39;s penis. The body portion  112  is large enough to contain at least a majority of the rod unit, when the rod unit  102  is retracted in the pubic region (see  FIG. 2 ). The legs  114  and  116  extend away from the rod unit, are configured for being implanted along sides of the penis&#39; shaft. The legs  114  and  116  and are configured for receiving rods  108  and  110 , respectively, when the rod unit  102  is deployed to the penis shaft to provide rigidity to the penis (see  FIG. 3 ). In a variant, the sheath  104  is made of membranous silicon. Optionally, the membranous silicon or any other material forming the sheath is thicker in body part than in legs, so that the sheath is somewhat rigid (e.g. rubbery) while the legs are membranous and thin. 
     Optionally, the sheath  104  is at least partially filled with a lubricant (e.g. a biocompatible lubricant), to ease the movement of the rod unit  102  within the sheath  104 . In a variant, the device  100  includes a plurality of loops  120  joined to an outer surface of at least one leg of the sheath  104 . The loops  120  may be used to ease suturing the sheath to an internal tissue of the patient, such as fascia or ligament, for example. The suture may be needed in order to prevent undesirable displacement of the sheath. 
     In a non-limiting example, the rod unit  102  may be configured as follows: a diameter of the rods and of the wire defining the curved section is about ⅛ to ¼ inches; a length of each rod is about 4-5 inches; a width of the curved section (i.e. the distance between the two rods) is about 1.5 to 2 inches; a depth of curved section (i.e., the maximal size along an axis perpendicular to the width of the curved section) is about 2 inches. It should be noted that the dimensions of the rod unit may vary according to the patient&#39;s individual need, as determined by a physician. Moreover, the physician may be able manufacture a rod unit  102  of desired dimensions, if stocks of the curved section  106  and rods  108  and  110 , as well as tools to join the rods to the curved section are supplied. 
     Reference in now made to  FIGS. 4 ,  5   a - 5   b , which are schematic drawings illustrating the use of the device of  FIGS. 2 and 3  when implanted within a patient. In  FIG. 4 , the rod unit  102  is retracted within the body portion of the sheath  104 . In  FIG. 5   a , the penis is rotated to deploy the rod unit into the legs of the sheath  104 , in order to lend some rigidity to the penis. In  FIG. 5   b , the penis is released while the rod unit is deployed. 
     As mentioned above, the body section  112  of the sheath  104  is implanted below the skin of the pubic region  200 , while the legs (of which only the leg  114  is shown) are implanted to extend along the shaft  202  of the penis. When the device  100  is not in use, the rod unit  102  is retracted within the sheath&#39;s body section in the pubic region (see  FIG. 3 ). With the body section  112 , the rods of the rod unit  102  are substantially vertical. Because under normal circumstances the penis is not vertical, the legs of the sheath are at an angle with the rods of the rod unit. This prevents the rod unit  102  to slide within the legs of the sheath. 
     When the patient wants to achieve an erection, he rotates or bends the penis shaft  202 , so that the penis shaft assumes a vertical orientation (see  FIG. 5   a ), enabling deployment of the rod unit  102 . Following the penis&#39; rotation, the legs of the sheath  104  extend vertically, and are aligned with the rods of the rod unit  102 . Thus, the rod unit  102  slips downward and the rods of the rod unit  102  are held by the legs of the sheath  104 . The curved section of the rod unit surrounds a portion on the base of the penis (except for the ventral section). 
     In  FIG. 5   b , the penis is released and returns to its natural orientation, while the rod unit is still in the deployed mode. It can be seen that the rod unit  102  is no longer vertical and is thus prevented from slipping back into the sheath&#39;s body section. 
     After completion of the sexual intercourse, the rod unit  102  may be guided back to the body section of the sheath  104 . For this purpose, the penis is to be rotated or bent to assume vertical orientation, the rods of the rod unit are pushed up, until the rod unit is back within the body section of the sheath  104 . The penis is then released to and returns to its natural orientation. 
     It should be noted that because the device is implanted in the soft tissue underneath the skin, the patient can easily handle the rod unit from outside: for example, the patient may push the rods upwards in order to cause the rod unit to retract, the patient may press on both ends of the curved section to strengthen the curved section&#39;s hold on the penis, and the patient may pull the ends of the curved section to weaken the curved section&#39;s hold on the penis. 
     Reference in now made to  FIG. 6 , which is a perspective drawing illustrating a cutout of a penis in which the device of  FIGS. 1 and 2  is engaged to provide rigidity to the penis. 
     As mentioned above, the device  100  is configured for being implanted under the patient&#39;s skin. In the penis shaft, the legs of the sheath  104  are under the patient&#39;s skin  202   a  and above the fascia  202   b . As mentioned above, the fascia  202   b  may be the superficial fascia or the deep fascia. Thus, when the rod unit is deployed, the curved section of the rod unit  102  slides in the region of the suspensory ligament  202   c  at the base of the penis. Optionally, the curved section of the rod unit  102  holds the suspensory ligament  202   c  at the base of the penis. 
     Reference in now made to  FIG. 7 , which is a schematic drawing illustrating an embodiment of the present invention in which a perforated enclosure is joined to an outer surface of at least one of the legs of the sheath. 
     According to some embodiments of the present invention, the device  100  includes a perforated enclosure  304  joined to an outer surface of at least one leg of the sheath  104 , and extending along the length of the leg. The perforated enclosure  304  has one or more openings  306 . The perforated enclosure is in fluid communication with a hollow reservoir  300  via a conduit  302 . Optionally, the reservoir  300  is implanted remotely in the patient&#39;s body, for example in lower abdominal area preferably. 
     The hollow reservoir  300  is configured for to receiving a fluid (e.g. a reagent and/or drug) from outside the patient&#39;s body (for example via an injection), and has an outlet  301  connected to conduit  308  for transferring the fluid to the perforated enclosure  304  via the conduit  308 . In this manner, the fluid can be released into the patient&#39;s body through the openings  306 , according to the patient&#39;s need. Preferably, the reservoir  300  includes a check valve at the outlet  301 . The valve is configured for letting the fluid flow from the reservoir  300  to the conduit  308  when at least a predetermined pressure is exerted on the reservoir  300  (e.g., by a user pressing on the reservoir  300 ). The reservoir  300  may be made of resilient rubbery material, so as to be substantially self-sealing when punctured to receive the fluid. 
     The fluid contained within/injected to the reservoir  300  may, for example, include one or more of the following: a biological lubricant for reducing the skin&#39;s resistance to the movement of the rods, an anesthetic agent to reduce pain, an antibiotic to locally control infection, phentolamine to reduce ischemic tissue damage, a locally-acting biopharmalogical agent to help with erection or repair anatomical defect, and stem cells, neurotrophine etc if medically appropriate. 
     Optionally, live tissue may be wrapped around the sheath&#39;s legs along penis shaft. The live tissue blocks the direct contact of penile tissue with non-biological synthetic material of legs (even if this material is biocompatible), and thus minimizes the possibility of the penile tissue&#39;s reaction to a foreign body. Live tissue wrapped around the legs increases the volume of the legs any may thus help keep the implant firm and stable, since a larger legs may have an increased resistance to motion. The live tissue may include peritoneum and/or tissue from the user&#39;s genital region. 
     Reference in now made to  FIGS. 8 ,  9   a  and  9   b , which are drawings illustrating an embodiment of the present invention in which the rod unit  102  includes two sections which are removably joinable to each other.  FIG. 8  is a perspective view of the rod unit  102 .  FIGS. 9   a  and  9   b  are top views of the rod unit  102  in its open mode and closed mode, respectively. 
     In this embodiment, the curved section  106  is formed by a first portion  106   a  having a first end  320  and a second portion  106   b  having a second end  322 . The locking mechanism between the first portion  106   a  and the second portion  106   b  may be formed by a male member at the first end  320  and female member located at the second end  322 . 
     When the rod unit  102  is stored in the sheath&#39;s body portion, the two sections may be separated and the first portion  106   a  and second portion  106   a  are slid one over the other (see  FIG. 9   b ). In this manner, the space required to store the rod unit in the sheath&#39;s body is reduced. When the rod unit is deployed in the sheath&#39;s legs, the two sections may be rejoined to each other. 
     Reference in now made to  FIG. 10 , which is a perspective drawing illustrating an embodiment of the present invention in which the rod unit includes a plurality of rods. 
     So far, the device  100  has been described having two rods in the rod device and two legs in the sheath. The present invention is not limited to this case. If fact, the rod device may include any number of substantially parallel rods (two, three, four, or more) joined to the curved section, and the sheath may include a corresponding number of legs, each leg being configured for accommodating a respective rod. By way of example,  FIG. 10  illustrates a rod unit  102  having four rods  114 ,  115 ,  116 , and  117 . 
     Reference in now made to  FIGS. 11 and 12 , which are perspective drawings illustrating a device  400  of the present invention which includes a curved base frame  402  joined to two hollow tubes  406 , each tube holding a sealed sleeve  408  enclosing a rod  410  which can be moved within the respective sleeve through the aperture of the base. The device  400  is an example of the device  10  of  FIGS. 1   a  and  1   b . The rods  410  correspond to the rods  10  and  12  of the device  10 , while the assembly formed by the curved base frame  402  and the tubes  406  is an example of interconnecting structure  16  of the device  10 . 
       FIG. 11  shows an example of the device  400 , in which the curved base frame  402  is a curved wire having two ends, each end being joined to a respective hollow tube.  FIG. 12  is a blown-up drawing illustrating the arrangements of a tube, a sleeve, and a rod. 
     The device  400  includes a curved base frame  402 , at least two tubes  406 , at least two sealed sleeves  408 , and at least two rods  410 . The curved base frame  402  is configured for being surgically implanted at the base of a patient&#39;s penis, below the skin and above or within or below the suspensory ligament, while not invading to penile fascia. When implanted, the curved base frame  402  is configured for being located in the pubic region in the vicinity of the base of the penis, to encircle a portion of the penis, while leaving the ventral section of the penis free. The curved base frame is substantially rigid, but may be somewhat flexible, in order to enable the patient to control the strength by which the curved base frame holds the penis via the rods. The curved base frame may be made of semi-rigid and/or semi-flexible metal and/or plastic materials. 
     The curved base frame has two ends. Two hollow tubes  406  are joined to the curved base frame in the vicinity of the respective ends of the curved base frame  402 . Each tube  406  extends away from the curved base frame, and is at an angle with a plane which includes the curved base frame. The tubes may be perpendicular to the plane of the curved base frame. When the device  400  is implanted in the penis, each tube  406  is located near or at the base of the penis, and extends toward the shaft of the penis. The tube  406  is traversed by a sealed sleeve  408  having a first portion  408   a  and a second portion  408   b . The first portion  408   a  is on a first (rear) side of the base  402  and extends away from the penis shaft, along the penis root or in the pubic region. The second portion  408   b  is on a second (front) side of the base  402  and is configured for being implanted to extend along the penis shaft. The sleeve is flexible (elastic) and soft, while being durable. Each sleeve  408  encloses a respective rigid rod. The rod is movable within the sleeve. 
     Optionally, the sleeves and rods are implanted before the curved base frame and tubes. The sleeves may be implanted either from perineal region (penis root) or from lower abdominal pubic region to the penis shaft. If the sleeves are preimplanted, the sleeves are to be inserted inside the respective tubes before implanation is completed. For this purpose, each tube may be somewhat elastic and may have a slit. In this manner, the each sleeve may be inserted in the corresponding tube via the slit, while requiring a minimal external force to force the tube open for insertion. The elasticity of the tubes will cause the tubes the close after the insertion of the sleeves is completed. 
     In a preferred embodiment of the present invention, each tube is a rigid member having dimensions selected for allowing the respective rod to move along the tube&#39;s central axis, while limiting the movement of the respective rod in other directions. Thus, the assembly formed by the curved base frame  402  and the tubes  406  (the interconnecting structure) stabilizes the rods when the rods are in the penis shaft, by limiting changes in position and orientation of the rods. 
     Optionally, a diameter of the second portion  408   b  of the sleeve is larger than the diameter of the sleeve&#39;s first portion  408   a , so that circumferential pressure exerted on the rod by the second portion  408   b  is lower than the circumferential pressure exerted on the rod by the first portion  408   a . In this manner, the rod is less likely to retract from sleeve&#39;s first portion  408   a  into the second portion  408   b.    
     The sleeve  408  may contain a lubricant to ease the rod&#39;s movement between the first portion and the second portion of the sleeve. 
     According to a non-limiting example, a length of the rod  410  may be about 4 to 5 inches, and a length of the tube  406  may be about 0.5 to 1 inches. The diameter of the rod is about ¼ to ⅛ of an inch. The dimensions of the curved base frame may be similar to the dimensions of the curved section of  FIGS. 2 to 10 . 
     In some embodiments of the present invention, the portion of the device  400  formed by the curved base frame  402  and the tubes  406  may be made of a single piece of material and manufactured via injection mold. 
     Reference in now made to  FIGS. 13 and 14 , which illustrate a use of the device of  FIG. 11 , in which one side of each sleeve is implanted in the root section of the penis while another side of the sleeve is implanted in the shaft of the penis. In  FIG. 13 , each rod is retracted in the root section of the penis. In  FIG. 14 , each rod is deployed in the shaft of the penis, to increase the rigidity of the shaft of the penis. 
     In the example of  FIGS. 13 and 14 , the base  402  holds the base of the penis, below the skin  202   a  and above or within or below the suspensory ligament  202   c , without exposing the fascia  202   b . The first portion  408   a  of the sleeve is implanted to extend along the root  203  of the penis. The second portion  408   b  of the sleeve is implanted in the penis shaft, below the skin  202   a  and above the fascia  202   b . As mentioned above, the fascia  202   b  may be the superficial fascia or the deep fascia. 
     When an erection is not needed, each rod is retracted in the first portion  408   a  of the sleeve ( FIG. 13 ). When an erection is not needed, the rod does not slide from the first portion  408   a  to the second portion  408   b  of the sleeve, since the first portion is at a non-zero angle with the second portion. 
     In order to deploy the rod  410  to the penis shaft, the penis is rotated so that the second portion  408   b  is aligned with the first portion  408   a  of the sleeve ( FIG. 14 ). The user pulls the rod  410  to the second portion  408   b  of the sleeve. Then, the penis is released, so that the first portion  408   a  and the second portion  408   b  of the sleeve are again at an angle. Thus, when the rod is deployed in the penis shaft, the rod may not freely slip into the first portion  408   a , because of the non-zero angle between the first and second portion. 
     Optionally, a ring  420  may be placed on the exterior of the penis shaft to apply pressure on the rods, in order to ensure that the rods do not slide back into the first portion  408   a  during sexual intercourse. In a variant the ring  420  has elastic properties, so that it constricts the penis when placed upon the penis. 
     Reference in now made to  FIGS. 15 and 16 , which illustrate a use of the device of  FIG. 11 , in which one side of the sleeve is implanted in the pubic and low abdominal region while another side of the sleeve is implanted in the shaft of the penis. In  FIG. 15 , each rod is retracted in the pubic abdominal region. In  FIG. 16 , each rod is deployed in the shaft of the penis, to increase the rigidity of the shaft of the penis. 
     The arrangement of  FIGS. 15 and 16  is similar to that of  FIGS. 13 and 14 . The only difference lies in the fact that in  FIGS. 15 and 16 , the first portion  408   a  of the sleeve is implanted in the pubic and low abdominal region and extends substantially vertically. The penis&#39; natural orientation is not vertical, thus when the penis is in its natural orientation, the rod  410  may not slide between the first and second portions of the sleeve. This helps maintain the rod retracted or deployed, as needed. 
     In order to deploy the rod to the penis shaft, the penis is rotated to assume a vertical orientation. In this manner the second portion  408   b  is aligned with the first portion  408   a , and the rod  410  slips through the tube to the second portion  408   b . In order to retract the rod back into pubic region, the penis is again rotate to assume a vertical orientation, and the rod can be pushed upward. 
     It should be noted that the patient&#39;s ability to manipulate and move the rod is brought about by the fact that the second portion  408   b  of the sleeve is well lubricated and implanted under the skin and above the deep or superficial fascia. 
     Reference in now made to  FIG. 17 , which is a schematic drawing illustrating an embodiment of the present invention, in which the device  400  of  FIG. 11  includes a perforated enclosure  304  joined to an outer surface of the portion of the sleeve implanted in the penis shaft and/or a plurality of loops  120  joined to an outer surface of the portion of the sleeve implanted in the penis shaft. The perforated enclosure  304 , as well as the reservoir  300  and conduit  308  associated therewith have been described in  FIG. 6 . The loops  120  have been described in  FIG. 2 . The loops  120  are configured for tying the device  400  to a suture, if needed. 
     In a variant, the perforated enclosure  304  is joined to the sleeve  408  on both sides of the curved base frame. The perforated enclosure  304  is fusedly connected to the sleeve  408 , and thus traverses the tube  406 . Optionally, the conduit  308  is joined to the perforated enclosure  304  in the vicinity of the tube  406  (thus, near the base of the penis). Thus, it is possible to deliver the fluid from the reservoir  300  to a section of the perforated enclosure  304  joined to the first portion  408   a  (and thereby to the penis root in the example of  FIGS. 13 and 14 ), to a section of the perforated enclosure  304  joined to the second portion  408   b  (and thereby to the penis shaft in the example of  FIGS. 13 and 14 ), or to both sections of the perforated enclosure  304 . This can be done by tilting the second portion  408   b  (the penis shaft) upward, downward, or horizontally to direct the incoming fluid to the desired location(s). Also, pressing on the section of the perforated enclosure  304  joined to the second portion  408   b  can be used to decrease or eliminate the flow of the fluid to the section of the perforated enclosure  304  joined to the second portion  408   b , and direct most of the fluid to the section of the perforated enclosure  304  joined to the first portion  408   a.    
     Reference in now made to  FIG. 18 , which is a schematic drawing illustrating an embodiments of the present invention, in which the device  400  of  FIG. 11  includes at least three rods. 
     In  FIG. 18 , an additional tube-sleeve-rod assembly as described above is joined to the wire-like curved base frame along the curve delineated by the wire-like curved base frame. 
     While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not of limitation. Likewise, the various diagrams may depict an example architectural or other configuration for the invention, which is done to aid in understanding the features and functionality that can be included in the invention. The invention is not restricted to the illustrated example architectures or configurations, but the desired features can be implemented using a variety of alternative architectures and configurations. Indeed, it will be apparent to one of skill in the art how alternative functional, logical or physical partitioning and configurations can be implemented to implement the desired features of the present invention. Also, a multitude of different constituent module names other than those depicted herein can be applied to the various partitions. Additionally, with regard to flow diagrams, operational descriptions and method claims, the order in which the steps are presented herein shall not mandate that various embodiments be implemented to perform the recited functionality in the same order unless the context dictates otherwise. 
     Although the invention is described above in terms of various exemplary embodiments and implementations, it should be understood that the various features, aspects and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which they are described, but instead can be applied, alone or in various combinations, to one or more of the other embodiments of the invention, whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment. Thus the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments. 
     Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as meaning “including, without limitation” or the like; the term “example” is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; the terms “a” or “an” should be read as meaning “at least one,” “one or more” or the like; and adjectives such as “conventional,” “traditional,” “normal,” “standard,” “known” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Likewise, where this document refers to technologies that would be apparent or known to one of ordinary skill in the art, such technologies encompass those apparent or known to the skilled artisan now or at any time in the future. 
     A group of items linked with the conjunction “and” should not be read as requiring that each and every one of those items be present in the grouping, but rather should be read as “and/or” unless expressly stated otherwise. Similarly, a group of items linked with the conjunction “or” should not be read as requiring mutual exclusivity among that group, but rather should also be read as “and/or” unless expressly stated otherwise. Furthermore, although items, elements or components of the invention may be described or claimed in the singular, the plural is contemplated to be within the scope thereof unless limitation to the singular is explicitly stated. 
     The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent. The use of the term “module” does not imply that the components or functionality described or claimed as part of the module are all configured in a common package. Indeed, any or all of the various components of a module, whether control logic or other components, can be combined in a single package or separately maintained and can further be distributed across multiple locations. 
     It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements. 
     Additionally, the various embodiments set forth herein are described in terms of exemplary block diagrams, flow charts and other illustrations. As will become apparent to one of ordinary skill in the art after reading this document, the illustrated embodiments and their various alternatives can be implemented without confinement to the illustrated examples. For example, block diagrams and their accompanying description should not be construed as mandating a particular architecture or configuration.