Abstract:
A system and related method for treating ED in a patient is provided. The system can include a small cuff or other selective restriction mechanism or device implanted at or along the existing veins of the penis to control blood flow out of the penis. As such, the system can utilize blood pressure from the heart to achieve and maintain an erection by restricting blood flow out of the penis.

Description:
PRIORITY CLAIM AND RELATED APPLICATION 
       [0001]    The present application claims the benefit of U.S. Provisional Application Ser. No. 61/423,795, filed Dec. 16, 2010, and entitled “SYSTEM AND METHOD FOR TREATING ERECTILE DYSFUNCTION” which is incorporated herein in its entirety by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention is generally related to implantable systems for the treatment of erectile dysfunction in men. More specifically, the present invention is directed to an implantable system that uses the existing circulatory system to create and maintain an erection in a patient. 
       BACKGROUND OF THE INVENTION 
       [0003]    Erectile dysfunction (“ED”) is believed to affect more than ninety million men in the United States and Europe, with seventeen million presenting with severe conditions that greatly interfere with the ability to initiate and maintain erections. ED may arise from a number of causes. Age brings on a lack of arterial elasticity in vessels supplying blood to erectile tissues. Damage to nerves necessary for initiating and sustaining erections brought on by chronic conditions (such as diabetes) or by injury can lead to dysfunction. A significant cause of nerve damage comes from injury that occurs during prostate surgeries, especially radical prostatectomies. Although new surgical procedures have been introduced that conserve the nerves in this region, a majority of men who undergo such procedures can still expect some degree of post-operative ED. 
         [0004]    A number of oral medications for treating ED have entered the marketplace in recent years, including VIAGRA, CIALIS and LEVITRA. These medications all provide significant relief to a large segment of men with ED. However, they each require that the medication be taken in advance of initiation of sexual activity and their effects may be delayed if ingested with food. Furthermore, the effectiveness of such drugs can vary greatly from patient to patient, and is even ineffective in a large cross-section of patients. 
         [0005]    Various treatments have also been tried in connection with ED, including a muscle constrictors or relaxers, such as Prostaglandin E1, administered by injection into the corpus cavernosum of the penis, positioning a suppository within the urethra and/or topically. These approaches allow for less advance preparation, but are neither consistently effective nor desirable applications across patient populations, especially radical prostatectomy patients. 
         [0006]    Implantable devices are also often used to address ED, especially when medications are ineffective or contraindicated. Typically, the implantable devices, such as implantable penile prosthetics, comprise at least one collapsible support that deploys to create an erection and retracts to conceal the support(s). However, these devices are often fully implanted within the patient&#39;s body, typically with a substantial portion of the device being implanted within the corpus cavernosum. As a result, the surgical procedure is often highly invasive often requiring positioning of multiple components throughout the pelvic region and reproductive organ. In addition, the implantation procedure can require a large incision and/or placement of temporary tubing to maintain the urology and reproductive functions of the penis following implantation and healing. Patients can become discouraged from pursuing this form of treatment by the extensive nature of the surgery. In addition, penile implants are an end stage treatment, and it is often desirable to provide treatment earlier in the disease state. Thus, there is a desire to obtain a minimally invasive yet effective and durable solution to treat ED that can be used with minimal to no side effects. 
       SUMMARY OF THE INVENTION 
       [0007]    The present invention is directed to treating ED by placing a constrictive cuff around at least one of the veins leaving one or both of corpus cavernosum of the penis. The constrictive cuff can be selectively tightened around the vein to reduce the inner diameter of the vein to create a back pressure within the corpus cavernosum to maintain the erection. The implantation of the cuff is minimally invasive and maintains the natural circulatory system of reproductive system. Unlike implantable devices where a support is positioned within the corpus cavernosum, the cuff assists in the normal operation of the penis without disrupting the urological or reproductive function of the penis. Similarly, in one aspect, the cuff is sized to maintain the flow of blood through the vein while creating the back pressure within the corpus cavernosum. The flow through the vein is maintained to prevent over pressuring of the corpus cavernosum. 
         [0008]    An implantable system for treating ED, according to an aspect of the present invention, comprises a constrictive cuff and an inflation system for controlling the tightening of the constrictive cuff. The constrictive cuff can further comprise a supportive backing and at least one inflatable chamber. In one aspect, the supportive backing can be positioned around the vein such that the inflatable chambers are positioned against the vein. The supportive back can be inelastic such that inflating the chambers tightens the chambers against the vein and reduces the effective inner diameter of the vein to create back pressure within the corpus cavernosum. Similarly, deflating the chambers allows the vein to re-expand and allow normal flow of the blood through the vein. In one aspect, the inflatable chamber or chambers can be sized and spaced along the backing such that inflation of the chambers presses the chambers against all sides of the vein to prevent crimping of the vein wall. In one aspect, the chamber or chambers can be shaped to bend the walls of the vein such that the inner diameter of the vein narrows to at least one choke point when the chambers are inflated. Alternatively, the chambers can be shaped to compress the walls evenly to maintain an constant inner diameter through the cuff. 
         [0009]    In one aspect, the supportive backing can comprise a flexible strap that can be wrapped around the vein. Alternatively, the supportive backing can comprise at least one rigid panel having a hinge portion for positioning the rigid panel to follow the contour of the wall of the vein. In either configuration, the supportive backing is non-elastic such that the inflation of the chamber or chambers does not cause the supportive backing to stretch and instead forces the chamber or chambers to expand against the walls of the vein to compress the vein. 
         [0010]    In one aspect, the chamber can comprise at least one predefined fold line defining a hinge portion for bending or folding the chamber to position the chamber around the vein. In this configuration, the chamber can be folded along the fold lines to define a plurality of faces, which contact the rounded wall of the vein to apply pressure to the vein to reduce the inner diameter of the vein. In another aspect, the chamber can further comprise a plurality of grooves that define a plurality of creases to define a continuous surface for contacting the wall of the vein. Similarly, each chamber can comprise at least one expansion groove positioned at the edges of the chamber or chambers. The expansion groove allow the chamber to expand when inflated to press against the vein and fold tightly against the supportive backing when the chamber is deflated to allow the vein to fully expand. 
         [0011]    A method for treating ED, according to an aspect of the present invention, comprises positioning a cuff around at least one vein exiting from the corpus cavernosum, wherein the cuff comprises at least one inflatable chamber positioned against a wall of the vein. The method further comprises positioning a supportive cuff around the exterior of each chamber to prevent outward expansion of the chamber during inflation. The method also comprises inflating each chamber to apply pressure to the wall of the vein to decrease the inner diameter of the vein so as to create back pressure within the corpus cavernosum to inflate and maintain the corpus cavernosum at a predetermined pressure. The method also comprises deflating each chamber to remove the pressure on the wall of the vein to allow the inner diameter of the vein to return to the normal size and lower the pressure of the blood within the corpus cavernosum. 
         [0012]    The above summary of the invention is not intended to describe each illustrated embodiment or every implementation of the present invention. The Figures and the Detailed Description that follow more particularly exemplify these embodiments. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    The invention can be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which: 
           [0014]      FIG. 1  is a schematic view of a representative circulatory system of a male reproductive system for use with the present invention. 
           [0015]      FIG. 2  is a schematic view of the representative circulatory system depicted in  FIG. 1  with a constrictive cuff, according to an embodiment of the present invention, positioned around a vein of the circulatory system. 
           [0016]      FIG. 2A  is an enlarged partial cross-sectional view of the constrictive cuff depicted in  FIG. 2 . 
           [0017]      FIG. 3  is a perspective view of a constrictive cuff according to an embodiment of the present invention in a rolled configuration. 
           [0018]      FIG. 4  is a front view of a constrictive cuff according to an embodiment of the present invention in an unrolled configuration. 
           [0019]      FIG. 5  is a front view of a constrictive cuff, according to an embodiment of the present invention, positioned around a representative vein. 
           [0020]      FIG. 6  is a front view of the constrictive cuff depicted in  FIG. 5  removed from the representative vein and in an unrolled configuration. 
           [0021]      FIG. 7  is a front view of a constrictive cuff according to an embodiment of the present invention. 
           [0022]      FIG. 8  is a front view of a constrictive cuff, according to an embodiment of the present invention, positioned around a representative vein. 
           [0023]      FIG. 9  is a front view of the constrictive cuff depicted in  FIG. 8  removed from the representative vein and in an unrolled configuration. 
           [0024]      FIG. 10  is a top view of a constrictive cuff, according to an embodiment of the present invention. 
           [0025]      FIG. 11  is a front view of the constrictive cuff depicted in  FIG. 10  in an unrolled configuration. 
           [0026]      FIG. 12  is a top view of a constrictive cuff, according to an embodiment of the present invention. 
           [0027]      FIG. 13  is a front view of the constrictive cuff depicted in  FIG. 10  in an unrolled configuration. 
           [0028]      FIG. 14  is a front view of a constrictive cuff, according to an embodiment of the present invention in a rolled configuration. 
           [0029]      FIG. 15  is a front view of the constrictive cuff depicted in  FIG. 8  and in an unrolled configuration. 
           [0030]      FIG. 16  is a side view of a constrictive cuff, according to an embodiment of the present invention in an unrolled configuration. 
           [0031]      FIG. 17  is a cross-sectional side view of the constrictive cuff depicted in  FIG. 16 . 
           [0032]      FIG. 18  is a schematic view of the representative circulatory system depicted in  FIG. 1  with a valve device, according to an embodiment of the present invention, positioned around an artery and a vein of the circulatory system. 
       
    
    
       [0033]    While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims. 
       DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0034]    As shown in  FIG. 1 , a representative circulatory system  20  for a male reproductive system generally comprises a heart  22 , an artery  24 , two corpus cavernosum  26  within the penis  28  and a vein  30 . Typically, the heart  22  operates to pump blood through the artery  24  into the corpus cavernosum  26  to inflate the corpus cavernosum  26  to create an erection. The artery  24  can further comprise a plurality of arterial branches  32  within the corpus cavernosum  26  for evenly distributing the blood. Similarly, the vein  30  can also comprise a plurality of vein branches  34  for collecting blood within the corpus cavernosum  26  to return the blood to the heart. During an erection, blood is still circulated into the corpus cavernosum  26  from the artery  24  and out of the corpus cavernosum  26  through vein  30 . The description of the circulatory system  20  is not intended to be limiting, but is provided simply to assist in the description of the present invention. 
         [0035]    As shown in  FIG. 2 , an implantable ED treatment device  40 , according to an embodiment of the present invention, comprises at least one constrictive cuff  42  and an inflation system  44 . As shown in  FIGS. 3 to 4 , each constrictive cuff  42  further comprises a supportive backing  46  and at least one inflatable chamber  48 . In one aspect, each cuff  42  can comprise multiple inflatable chambers  48  positioned along the length of the supportive backing  46  as shown in  FIG. 3 . Alternatively, each cuff  42  can comprise a single inflatable chamber  48  extending along the length of the supportive backing  46  as shown in  FIG. 4 . In one aspect, the inflation system  44  can be operably linked to the constrictive cuff  42  by kink resistant tubing  50  such that the inflation system  44  can inflate each chamber  48  with a working gas or fluid. 
         [0036]    As shown in  FIGS. 2 ,  2 A and  3 - 4 , the cuff  42  is foldable between a rolled configuration and an unrolled configuration. In the rolled configuration, the cuff  42  can be positioned around the vein  30  such that each inflatable chamber  48  is positioned against the vein  30 . As shown in  FIG. 2A , each inflatable chamber  48  can be inflated to compress against the vein  30  to reduce the inner diameter of the vein  30 . The expansion of the inflatable chamber  48  limited to reduce the inner diameter of the vein  30  without fully closing off the vein  30  preventing over pressuring of the corpus cavernosum  26 . In one aspect, the cuff  42  can comprise stops, sensors, and other limiting mechanisms or techniques can be employed to ensure that the blood flow is monitored and/or not completely stopped. The supportive backing  46  is non-elastic such that each inflatable chamber  48  only expands inward toward the vein  30 . The reduced inner diameter of the vein  30  increases the pressure within the corpus cavernosum  26  to create an erection. Similarly, each inflatable chamber  48  can be deflated to allow the vein  30  to return to the normal diameter and allow the corpus cavernosum  26  to return to the normal pressure. 
         [0037]    A method for treating ED according to an aspect of the present invention comprises positioning the cuff  42  having the at least one inflatable chamber  48  around the vein  30  such that the inflatable chamber  48  is positioned against the vein  30 . The method further comprises inflating each inflatable cylinder  48  to constrict the vein  30  creating back pressure within the corpus cavernosum  26 . Finally, the method comprises deflating each chamber  48  such that the vein  30  returns to its original diameter. 
         [0038]    As shown in  FIGS. 5 to 7 , according to an aspect, the cuff  42  can further comprise at least one rigid panel  52  positioned on the supportive backing  46  for maintaining the shape of the cuff  42 . In one aspect, the rigid panels  52  can be positioned on the exterior of the supportive backing  46  as shown in  FIGS. 5 to 6 . In another aspect, the rigid panels  52  can be positioned between the chamber  48  and the supportive backing  46  as shown in  FIG. 7 . In either configuration, the supportive backing  46  comprises a flexible material. 
         [0039]    As shown in  FIGS. 8 to 9 , in one aspect, the supportive backing  46  can comprise a plurality of rigid sections  54  and flexible section  56 . The rigid sections  54  and flexible sections  56  are alternated such that the flexible sections  56  can be bent such that the rigid sections  54  define the sides of a polygonal shape. The rigid sections  54  support the cuff  42  to maintain the shape of the cuff  42  when the cuff  42  is positioned around the vein  30 . Similarly, as shown in  FIGS. 14 to 15 , in one aspect, the supportive backing  46  can comprise at least one fold line  62  defining a hinge portion along which the supportive backing  46  can be folded. In this configuration, the supportive backing  46  can comprise a rigid material to maintain the shape of the cuff  42  once wrapped around vein  30 . 
         [0040]    As shown in  FIGS. 10 to 11 , in one aspect, the inflatable cushion  48  can comprise at least one fold line  58  to form a crease in the inflatable cushion  48  when cuff  42  is positioned around a vein  30 . The inflatable cushion  48  can often crease when the cuff  42  is wrapped around the vein  30 . The creases can be formed too close together such that the cushion  48  does not evenly press against the vein  30  as the cushion  48  is inflated. The fold line  58  forms predefined creases such that the creases are evenly spaced around the vein  30 . Similarly, as shown in  FIGS. 12 to 13 , in one aspect, the inflatable cushion  48  can comprise a plurality of grooves  60  defined along the entire surface of the cushion  48 . The grooves  60  are positioned such that the inflatable cushion  48  provides continuous contact to the inflatable cushion  48  to prevent damage to the vein  30 . 
         [0041]    As shown in  FIGS. 16 to 17 , the inflatable cushion  48  can further comprise at least one expansion crease  64  defined at the edges of the inflatable cushion  48 . The creases  64  are adapted to open when the cushion  48  is inflated to allow the cushion  48  to expand. Similarly, the creases  64  are adapted to reform when the cushion  48  is deflated to allow the vein  30  to fully re-expand. 
         [0042]    In one aspect, the cuff  42  can further comprise actuation devices, automated sensors and like devices to control the restriction level and timing of the cuff  42 . The relative constriction of the vein  30  controls the pressure within the corpus cavernosum  26 . The constriction of the cuff  42  can be adjusted such that the relative pressure within the corpus cavernosum  26  can be increased or decreased depending on the patient&#39;s preference. Similarly, the constriction of the cuff  42  can be adjusted to adapt the operation of the cuff  42  for each patient&#39;s unique physiology allowing for consistent performance across multiple patients. 
         [0043]    As shown in  FIG. 18 , in one aspect, the present invention can include a valve  70  or other regulation device in combination with or in lieu of the micro cuff  42 . The valve device  70  can regulate and direct flow through the artery into the corpus cavernosum  26 . The valve device  70  can also control the flow from the vein from the corpus cavernosum. During an erection, the valve device  70  can close off or limit blood flow out of the penis, as shown in  FIG. 2 . In a non-erect or flaccid condition, the valve device  70  can remains open to enable blood to freely flow out of the corpus cavernosum  26 . In one aspect, the valve  70  can also constrict the artery  24  to control the flow of the blood into the corpus cavernosum  26  to maintain the cavernosum  26  at a predetermined pressure. 
         [0044]    A variety of materials may be used to form portions or components of the present invention, including nitinol, polymers, elastomers, thermoplastic elastomers, metals, ceramics, springs, wires, plastic tubing, and the like. 
         [0045]    All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated, and include those references incorporated within the identified patents, patent applications and publications. Obviously, numerous modifications and variations of the present invention are possible in light of the teachings herein. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced other than as specifically described herein.