Abstract:
A method of treating Peyronie&#39;s disease through implantation of a supporting structure in a penis suffering from a Peyronie&#39;s plaques affected area includes providing an incision in the penis and accessing the Peyronie&#39;s plaques affected area. The method includes excising plaque out of the Peyronie&#39;s plaque affected area and exposing exposed tissue of the penis, and placing an implant on the exposed tissue of the penis. The implant has a sheet component attached to a reinforcing component. The method includes positioning the implant allowing for tissue ingrowth into the sheet component and providing column strength to the exposed tissue of the penis with the reinforcing component of the implant, and securing the implant subcutaneously to the penis prior to closing the incision.

Description:
BACKGROUND 
     Peyronie&#39;s disease is manifested by an abnormal bend that occurs in the erect penis of the sufferer and can be associated with painful erection and/or painful intercourse. 
     Peyronie&#39;s disease is related to the development of scar tissue, or plaques, that form on tissues (e.g., tunica albuginea) inside the penis. One non-surgical approach for the treatment of Peyronie&#39;s disease includes injecting drugs into the plaques that lessen the compression applied by the plaques to the erect penis. The research and efficacy of this approach is limited. 
     Surgical treatments for Peyronie&#39;s disease include excising portions of the tunica albuginea from the penis opposite the plaque and closing the fenestrations with sutures. Access to the tunica albuginea is achieved by first degloving the penile skin away from the penis to expose the Buck&#39;s fascia and tunica albuginea along the length of the penis. Degloving the penile skin is painful and the recovery time for the patient can be several weeks. Although the long term results of this surgical approach are good, both short term (within 8 weeks) and long term failures can present with residual penile deformity. 
     Another surgical treatment includes corporal plication in which plication sutures are placed on the contralateral side of the plaque without excising the tunica albuginea or removing the plaque. Corporal plication is most commonly employed subsequent to a previous Peyronie&#39;s treatment surgery to correct small angles of residual penile deformity. 
     Patients and clinicians desire more effective treatments for Peyronie&#39;s disease. 
     SUMMARY 
     One aspect provides an implant that includes one or more sheet components attached to at least one reinforcing component. The at least one reinforcing component provides column strength to the implant and the one or more sheet components provides support for penile tissue. The implant is adapted to be positioned on a Peyronie&#39;s plaques affected area of a penis. The implant is configured to elongate during an erection of the penis and to contract when the penis returns to its flaccid state. 
     One aspect provides an implant for treatment of Peyronie&#39;s disease. The implant includes a skeletal framework having one or more sheet components attached to at least one reinforcing component to support penile tissue and to provide a flexible, yet strong and durable implant. The sheet components are at least partly made from a biocompatible material. The implant is placed subcutaneously on an affected area of the penis. The skeletal framework of the implant allows for elongation of the implant during erection of the penis and for contraction of the implant when the penis is returning to its flaccid state. To secure the implant to the penis, the skeletal framework includes at least one attachment mechanism. 
     One aspect provides an implant that includes a skeletal framework having one or more sheet components attached to a plurality of reinforcing components that provide column strength along a longitudinal direction of the implant and the sheet components provide support for penile tissue. The skeletal framework of the implant allows for elongation of the implant during erection of the penis and for contraction of the implant when the penis is returning to its flaccid state. 
     One aspect provides an implant that includes a skeletal framework having one or more sheet components attached to at least one reinforcing component that provide support for penile tissue and column strength to the implant, respectively. The implant is configured to be placed underneath the upper skin layer of the penis (e.g. on the tunica albuginea, T.A.) on an affected area of the penis and forms an arch describing 180 degrees or less. 
     One aspect provides an implant that includes a skeletal framework having one or more sheet components attached to a plurality of reinforcing components and at least one attachment mechanism including a suture line attached to the skeletal framework at one end and a hook-shaped needle for tissue penetration attached at a second end of the suture line and at least one anchor provided on the suture line for securing the implant to the penis. 
     One aspect provides a method of treating Peyronie&#39;s disease. The method includes implanting an implant including one or more sheet components attached to a reinforcing component. The method includes performing an incision to gain access to the penile tissue affected by the Peyronie&#39;s plaques and excising the scar tissue. The method includes providing the implant on the affected area. The method includes positioning the implant so as to provide for optimal tissue ingrowth and for optimizing column strength in the implant. The method includes securing the implant to the penis. The method includes closing the incision. 
     Embodiments provide an implant that eliminates or reduces the physical effects of the Peyronie&#39;s disease. Embodiments of the implant described in this application have improved sustainability and durability and thus reduces or eliminates the potential for surgical revision and/or substitution of the implant. A further object is to provide a Peyronie&#39;s treatment implant that is easily manageable and has improved flexibility in order to improve patient perception and comfort. A further object is to provide an implant that supports and reinforces the affected penile tissue area where the plaques have been removed. A still further object is to provide an implant that is easily implantable and obviates the use of other tools to attach the implant to the penile tissue. A further objective is to provide another alternative to a medicament based treatment option for Peyronie&#39;s disease. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts. 
         FIG. 1A  is a top view of one embodiment of an implant. 
         FIG. 1B  is a top view of one embodiment of an implant. 
         FIG. 1C  is a perspective view of an erect penis afflicted by Peyronie&#39;s disease indicating where the implant of  FIG. 1B  is to be applied on the penis. 
         FIG. 1D  is a side schematic view of the penis illustrated in  FIG. 1C  in a flaccid state and including an implant attached to the tunica albuginea of the penis. 
         FIG. 1E  is a side schematic view of the penis illustrated in  FIG. 1D  in an erect state having reduced curvature as compared to the untreated penis illustrated in  FIG. 1C . 
         FIG. 2A  is a schematic top view of one embodiment of reinforcing components of a skeletal framework and an attachment mechanism of an implant. 
         FIG. 2B  is a schematic side view of the embodiment illustrated in  FIG. 2A . 
         FIG. 2C  is a schematic view of one embodiment of an implant. 
         FIG. 2D  is a schematic view of one embodiment of an implant. 
         FIG. 2E  is a schematic view of one embodiment of an implant. 
         FIG. 3A  is an enlarged, schematic cross-sectional view of one embodiment of a reinforcing component configured as a rectangular rod including a radially extending flange at an end. 
         FIG. 3B  is an enlarged, schematic cross-sectional view of one embodiment of a reinforcing component configured as a circular column including a radially extending flange at an end. 
         FIG. 4A  is a schematic top view of one embodiment of an implant including a skeletal framework having sheet components attached to reinforcing components. 
         FIG. 4B  is a schematic side view of the implant as illustrated in  FIG. 4A  including longitudinal rods of the reinforcing components configured as circular columns and sheet components enclosing the reinforcing components. 
         FIG. 4C  is a schematic side view of one embodiment of a sheet component configured as a porous support. 
         FIG. 4D  is a schematic top view of one embodiment of a sheet component configured as a mesh or mesh-like structure. 
         FIG. 5A  is a perspective view of one embodiment of an implant. 
         FIG. 5B  is a perspective view of one embodiment of an implant. 
         FIG. 5C  is a perspective view of one embodiment of an implant. 
         FIG. 6  is a schematic cross-sectional view of a penis with the implant illustrated in  FIG. 5A  positioned on the tunica albuginea of the penis. 
         FIG. 7  is a schematic top view of a penis showing a position and a configuration of the implant illustrated in  FIG. 5C  implanted in the penis. 
         FIG. 8  is a block diagram of one embodiment of a method of treating Peyronie&#39;s disease. 
     
    
    
     DETAILED DESCRIPTION 
     In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims. 
     It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise. 
     Tissue includes soft tissue, which includes dermal tissue, sub-dermal tissue, ligaments, tendons, or membranes. 
     Anterior means “forward” or “front,” and posterior means “rearward” or “back.” Relative to surfaces of an organ in the human body, an anterior surface is oriented forward toward the belly and a posterior surface is oriented rearward toward the spine. 
     The term “proximal” as employed in this application means that part that is situated next to or near the point of attachment or origin or a central point: as located toward a center of the human body. The term “distal” as employed in this application means that part that is situated away from the point of attachment or origin or the central point: as located away from the center of the human body. A distal end is the furthest endmost location of a distal portion of a thing being described, whereas a proximal end is the nearest endmost location of a proximal portion of the thing being described. For example, the glans penis is located distal and of the crus of the penis is located proximal relative to the male body such that a distal end of a corpora cavernosum of the patient extends about midway into the glans penis. 
       FIG. 1A  is a top view of one embodiment of an implant  20  for treating Peyronie&#39;s disease. The implant  20  includes at least one reinforcing component  22  attached to a sheet component  32 . In one embodiment, the implant  20  includes two or more sheet components  32 . The sheet component(s)  32  are fabricated to reduce the build-up of new scar tissue around the implant  20 , which promotes new tissue generation surrounding the implant  20  resulting in stronger and more durable regenerated tissue. The sheet component  32  is selected to be bio-compatible with implantation into a human body and is configured to be porous to allow tissue ingrowth throughout its structure and thus anchor the sheet component  32  in the body after implantation and healing. Suitable sheet component  32  include autograft material (the patient&#39;s own tissue), allograft material (tissue from a cadaver), xenograft material (tissue from another species), or synthetic materials such as woven fabrics, meshes, nonwoven fabrics, meshes, fibrillated fibers, or spun and fibrillated fibers that are provided with voids (pores) configured to allow tissue ingrowth into the sheet component  32 . The pores are generally larger, on average, than 75 μm. 
     The implant  20  is flexible laterally and longitudinally, e.g., in directions indicated by arrows FA 1  and FA 2  and thus configures to elongate during an erection of the penis and contract when the penis returns to its flaccid state. The implant  20  is adapted to be positioned on an area of a penis from where the Peyronie&#39;s plaques or scar tissue has been excised (see also  FIGS. 1C-1E ). The reinforcing component  22  provides column strength to the implant  20  and the sheet components  32  provides support for penile tissue. 
     The illustrated skeletal framework  21  includes an attachment mechanism  25  for securing the implant  20  to the penis. The attachment mechanism  25  includes a barbed line  25  and a needle  29 . The barbed line  25  is configured to glide smoothly and easily in an insertion direction into tissue (i.e., the barbed line  25  has low resistance going into the tissue). Conversely, the barbed line  25  is configured to resist movement of the attachment mechanism  25  in an extraction direction from this tissue. The needle  29  is provided to guide the barbed line  25  into the tissue, after which the needle  29  is removed, leaving the barbed line  25  secured within the tissue. The illustrated embodiment includes a skeletal framework  21  wherein the distal and/or the proximal ends of at least some of the reinforcing components  22  are defined by a radially extending flange  28 . This will be explained in more detail below. 
       FIG. 1B  is a top view of one embodiment of an implant  20 ′. The implant  20 ′ includes a skeletal framework  21  including one or more of the sheet components  32  described above attached to at least one reinforcing component  22 . The implant  20 ′ is flexible laterally and longitudinally, e.g., in directions indicated by arrows FA 1  and FA 2 . The sheet components  32  of the implant  20  include a biocompatible material which reduces the build-up of scar tissue around the implant  20  and promotes new tissue generation surrounding the implant  20  resulting in stronger and more durable regenerated tissue. The components  22  and  32  provide a biocompatible and flexible, but relatively strong and durable implant  20  that is implanted in the penis P after the excision of the Peyronie&#39;s plaques. The illustrated skeletal framework  21  includes an attachment mechanism  25  for securing the implant  20  to the penis. In  FIG. 1B , the distal and/or the proximal ends of at least some of the reinforcing components  22  are defined by a radially extending flange  28 . 
     Embodiments include reinforcing components  22  configured to include longitudinal rods  23  and transverse connectors  24 . 
       FIG. 1C  is a perspective view of an erect penis afflicted by Peyronie&#39;s disease,  FIG. 1D  is a side view of the flaccid penis treated with the implant  20 ′, and  FIG. 1E  is a side view of the erect penis supported by the implant  20 ′. Patients who suffer from Peyronie&#39;s disease develop a curvature in the erect penis often manifested in one side of the penis having an unaffected length and, generally, an opposite side of the penis having an affected length that is shorter than the unaffected length of the penis. The implant  20 ′ is configured to be implanted in the penis P to alleviate this condition. In embodiments, the skeletal framework  21  has a length that is selected to stretch between a first initial length in its position covering at least a portion of the excised plaques area between a base B of the penis P and a corona C of the penis when the penis is flaccid to a final length that is approximately equal to the plaque affected length of the penis. The skeletal framework  21  is thus configured to move with the penis P between its flaccid state and its erect state, and when the penis is erect, the implant  20 ′ is configured not only to support the penile tissue but also to straighten the penis P to an approximately symmetric shape/length ( FIG. 1E ). 
     The implant  20 ′ is attached subcutaneously to an exterior surface of the tunica albuginea TA at least on an affected area  40  of the penis P from which the Peyronie&#39;s plaque has been excised, and functions to support the exposed penile tissue and to keep the penis straight during an erection. The skeletal framework  21  is fabricated from materials that provide for the implant to be elongatable during an erection of the penis and correspondingly contractible when the penis returns to its flaccid state and are biocompatible. 
     Embodiments include materials having shape memory. The shape memory material has at least two stable states. This includes a first state corresponding to a flaccid state of the penis and another state when the penis is erect. When exposed to an external force such as heat or electricity, the material changes between its stable states. In other words, shape memory materials have the ability to return or recover to their original shape at the presence of the right stimulus, such as a heat or strain influence. One example of such a force in terms of heat could be when blood flows into the corpora cavernosum to create an erection of the penis. This blood flow causes the surrounding tissue of the penis to increase in temperature, which in turn changes the state of the shape memory material. This provides an implant that suitably configures to further support or sustain a straight erection of a penis. Configuring the shape memory material such that it changes state to a straight or stretched configuration when influenced by the warm blood flow of the erection provides an implant that supports a straight erection of the penis. 
     Suitable materials for fabricating the reinforcing components  22  of the implant  20  configured by the longitudinal rods  23  and the transverse connectors  24  include biocompatible materials such as Nitinol, a metal alloy of nickel and titanium also having shape memory and superelasticity characteristics, or a shape memory polymer, e.g. based on polyurethane. 
       FIG. 2A  is a top view of one embodiment of an implant  30 . The implant  30  includes reinforcing components  22  of a skeletal framework  21  and an attachment mechanism  25 . 
     The components  22  of the skeletal framework  21  are assembled to provide at least one substantially rectangular framework ABCD. “Substantially rectangular” means that the reinforcing components  22  of the implant  30 , including the longitudinal rods  23  and the transverse connectors  24 , are arranged at an angle α in a range of approximately 85-95 degrees in relation to each other. A first transverse connector  24   d  is attached to the distal ends of two neighbouring longitudinal rods  23  and a second transverse connector  24   p  is attached at the proximal, or opposite, ends of the neighbouring longitudinal rods  23 . 
     Embodiments include a skeletal framework  21  having further longitudinal rods  23  and transverse connectors  24  configuring, more than one rectangular framework. To accommodate differences in size of Peyronie&#39;s plaque affected areas of penile tissue on individual patients, the number of reinforcing components  22  suitably includes more than two longitudinal rods  23  and two transverse connectors  24 .  FIG. 2A  illustrates, as an example, three rectangular frameworks ABCD, EAFC and GEHF arranged in a side-by-side configuration. In  FIG. 2A , longitudinal rod  23  extending between positions A and C configures to be part of both rectangular framework ABCD and EAFC, or can be said to be shared between those rectangular frameworks. Similarly, longitudinal rod  23  extending between positions E and F is part of both rectangular frameworks EAFC and GEHF. Embodiments include a skeletal framework  21  wherein more than one, or all longitudinal rods  23  are attached to a single transverse connector  24   ds  at their distal ends and correspondingly to another single transverse connector  24   ps  at their proximal ends. 
       FIG. 2B  is a cross-sectional view of the implant  30  illustrating an embodiment in which the transverse connectors  24  include a link  26  that pivots to provide additional flexibility to the implant  30 .  FIG. 2B  also illustrates the attachment mechanism  25  attached to a longitudinal rod  23 . 
       FIG. 2C  is a top view of an embodiment of an implant  40  with the skeletal framework  21  assembled in two rhomboids R1,R2. The rhomboids R1,R2 are arranged with an angle β between rhomboid R1 and rhomboid R2. For example, the longitudinal rod  23  of one rhomboid R1 is at an angle β with a longitudinal rod  23  of a second rhomboid R2. This provides a flexible implant  40  having a larger width L 2  at one (e.g. proximal) end of the longitudinal rods  23  of the skeletal framework  21  and a shorter length L 1  at the opposing (e.g. distal) end. In embodiments, the rhomboids R1,R2 share the same single transverse connectors  24   ds ,  24   ps  at their distal and proximal ends, respectively. However, the rhomboids R1,R2 suitably each include individual transverse connectors  24  at their distal and proximal ends. 
     In embodiments, the skeletal framework  21  configures as at least one rhomboid in which the longitudinal rods  23  and transverse connectors  24  are arranged at angles being less than 85 and more than 95 degrees. 
       FIG. 2D  is a top view of one embodiment of an implant  50  and  FIG. 2E   2 D is a top view of one embodiment of an implant  60 . These implants  50 ,  60  likewise include a skeletal framework including an uneven number of longitudinal rods  23  and transverse connectors  24 . This includes configuring different polygon shapes of the implants  50 ,  60  such as, but not limited to, triangles and pentagons. In  FIG. 2D , the plurality of reinforcing components  22  of the skeletal framework of the implant  50  has at least three reinforcing components including two longitudinal rods  23  and one transverse connector  24  so as to provide a triangular configuration of the implant  50 . Embodiments include one or more longitudinal rods coupled with one or more transverse connectors. In some embodiments, the transverse connectors  24  include one or more pivotable links  26  ( FIG. 2B ) between and/or at their opposing ends, thereby providing additional flexibility to the implant  20 . 
     As further illustrated in  FIGS. 1A, 1B, 2A and 2B , embodiments include a skeletal framework  21  wherein the distal and/or the proximal ends of the longitudinal rods  23  are defined by a radially extending flange  28 . This is further illustrated in the schematic cross-sectional view of  FIG. 3A . The flange  28 , or flanges, if both the distal and the proximal ends of the longitudinal rods  23  are configured to include a flange, has a total extent in a crosswise direction of the longitudinal rod  23  of 1.25-4 times the width w of the longitudinal rod  23 . Embodiments also include a skeletal framework  21 ′ having longitudinal rods  23  configured as circular columns  27  as indicated in  FIG. 3B . The columns  27  include diameters in the range of 0.01-1.0 mm. 
     In the case of longitudinal rods  23  configured as circular columns  27  the width w corresponds to the diameter of the column  27 . 
     Embodiments also include a skeletal framework  21  wherein the reinforcing components  22  are injection molded. Configurations wherein some of the reinforcing components  22  are injection molded and some are fabricated otherwise, such as by casting or extrusion, are also included. Embodiments include a skeletal framework  21  wherein the reinforcing components  22  are injection molded as an integrated frame ABCDEFGH ( FIG. 2A ). Material examples for injection molded reinforcing components  22  include thermoplastics such as polyethylenes or polypropylenes. 
     Embodiments include a skeletal framework  21  wherein the transverse connectors  24  are attachable to the radially extending flange  28 , or flanges, of the longitudinal rods  23  and/or vice versa. Attaching the transverse connectors  24  and the longitudinal rods  23  at the radially extending flanges  28  provides a flexible, yet stable and strong skeletal framework  21  for reinforcement of the implant  20 . In embodiments, the reinforcing components  22  of the skeletal framework  21  are attached to each other by a suitable type of welding, gluing or other type of mechanical connection. As illustrated in several figures, embodiments include an implant  20  wherein an attachment mechanism  25  is provided on the skeletal framework  21  to attach the implant  20  to the penis P. In contrast to providing a separate needle and suture for attachment of the implant to the tissue, embodiments provide an implant  20  including such attachment means that provides the surgeon with a more flexible choice in regard to positioning the implant  20  on the penile tissue. Embodiments provide an implant  20  that can be attached to whatever portion of the penile tissue that is desired. Furthermore, this reduces the need for additional surgical equipment and also reduces the need for assistance for the surgeon. Embodiments include an attachment mechanism  25  having a first end  25   a  being fixedly connected to a first longitudinal rod  23  and a second end  25   b . This includes embodiments wherein the implant  20  is attached to the penis P without penetrating tissue instead the attachment mechanism  25  attaches onto the implant  20  itself such as, but not exclusively, in a cylindrical configuration of the implant  20  as illustrated in  FIG. 5B . 
     With reference to  FIGS. 2A and 2B , the attachment mechanism  25  is configured by a suture line  25   c  having a detachable needle  29  at a second end  25   b  so as to attach the implant  20  to the penis P by suturing it on to the penile tissue. In embodiments, the detachable needle  29  includes a hook-shaped surgical needle. The needle  29  is configured to penetrate a targeted tissue to be able to pull the suture line  25   c  through penetrated tissue. The needle  29  is suitably attached to the suture line  25   c  at the first end  25   a  by tying a knot or in other suitable ways. In embodiments, the needle  29  is detached by cutting the suture line  25   c  or untying the knot at the first end  25   a . In embodiments, one or more anchoring barbs  31  are configured along the suture line  25   c  between the first and second ends  25   a , 25   b . The anchoring barbs  31  include several single-side tapered protrusions extending radially from the suture line  25   c  to provide stopping surfaces to prevent the anchoring barbs  31  (and thus the suture line  25   c ) from slipping backwards once having been pulled through the penetrated tissue. In embodiments, the anchoring barbs  31  are provided as one or more separate elements attachable to the suture line  25   c . In embodiments, the anchoring barbs  31  are made integral with the suture line  25   c . In embodiments, the second end  25   b  of the attachment mechanism is configured by a second end of the suture line  25   c  that is attachable to another, or different, component of the implant. Embodiments include an attachment mechanism at least partly made from one or more biocompatible material which may also be absorbable in the body. 
       FIG. 4A  is a schematic top view of an embodiment of the implants  20 ′/ 30 .  FIG. 4B  is a schematic cross-sectional view of the implants  20 ′/ 30 . The figures include an illustration of the sheet components  32  of the implant  20  that are at least partly made from a fibrous and porous biocompatible material which reduces the build-up of fibrosis tissue around the implant  20  and promotes new tissue generation by improved re-epithalization of cells surrounding the implant  20  resulting in stronger and more durable regenerated tissue.  FIG. 4B  illustrates sheet components  32  surrounding or enclosing the reinforcing components configured by longitudinal rods  23  and transverse connectors  24 . In embodiments, the sheet components  32  are configured as a single individual sheet. In other embodiments, the one or more sheet components is/are configured as at least one sheath. This sheath configures an envelope for at least partly enclosing the reinforcing components  22 . 
     In embodiments, the sheath components  32  of the implant  20  include porous supports  33 . Porous supports  33  include sheet components  32  including a material that is capable of supporting penile tissue while still being at least partly open pored or having wholly or partly through-going pores to provide for ingrowth of penile tissue into and/or through the sheet components  32  as shown in  FIG. 4C . Spanning the implant  20  by means of the skeletal framework  21  having the sheet components  32  configured between the reinforcing components  22  to support the penile tissue provides for a very flexible, yet durable and strong implant  20  that facilitates and/or improves potential ingrowth of regenerated tissue and reduces bulkiness of the implant and improves patient comfort. In embodiments, the reinforcing components  22  of the skeletal framework  21  are covered by the porous supports  33 , either partly or wholly such as by enclosing the reinforcing components  22  between two layers of porous support  33  or by enveloping the reinforcing components  22  in the porous supports  33 . In embodiments, the porous supports  33  include pericardium tissue. The pericardium tissue may be chosen from a variety of sources including human or bovine pericardium tissues. Alternatively, the porous supports  33  include artificially grown tissues and/or fabricated mesh-like structures  34  ( FIG. 4D ). Fabricated mesh-like structures  34  include materials such as polyethylenes or other biocompatible material components. Suitable materials for the mesh-like structures include high-density polyethylene fiber substrates such as TYVEK® available from DuPont™ or TUTOPLAST® processed pericardium available from Coloplast Corp., Minneapolis. In embodiments including a rhomboid configuration of the skeletal framework  21  of the implant  20 , the angular space spanned by the angle β between neighbouring longitudinal rods  23  of the rhomboids R1,R2 ( FIG. 2C ) suitably additionally include one or more sheet components  32 , such as a porous support  33 . 
     In embodiments, the sheet components  32  and/or the reinforcing components  22  of the implant include materials that are absorbable in the human body over an approximate pre-determined time. One suitable implant  20  is fabricated wholly or in part from absorbable components. Suitable materials for the sheet components  32  and/or for the reinforcing components  22  of the implant  20  include materials that provide for a permanent and stable implant in order to sustain the effect of the implant  20  for as long as desired. In some embodiments, the sheet components  32  of the implant  20  suitably are configured to be exchangeable while the reinforcing components  22  are configured to be maintained or re-used with the exchanged sheet components  32 . 
     In embodiments, the sheet components  32  include one or more tissue-ingrowth promoters TIP. In embodiments, the tissue-ingrowth promoters TIP are coated onto the sheet components  32 . The tissue-ingrowth promoters TIP are included to support or enhance the re-epithalization of cells to help regenerate and reinforce penile tissue and/or reduce the length of the rehabilitation period after surgery. One example of a tissue-ingrowth promoter TIP includes platelet-rich plasma. 
       FIG. 5A  illustrates one embodiment where an individual one of the implants  20 ,  20 ′,  30 ,  40 ,  50 ,  60  described above form an arch  45  describing 180 degrees or less. The implants  20 ,  20 ′,  30 ,  40 ,  50 , or  60  includes the attachment mechanism  25 . The implant  20  is suitably partly or wholly configured to follow at least a part of a circumferential curvature of the exposed penile tissue. 
       FIG. 5B  is a schematic illustration of an embodiment where an individual one of the implants  20 ,  20 ′,  30 ,  40 ,  50 , or  60  described above is provided in a cylindrical configuration. Some patients may require substantial removal of Peyronie&#39;s plaques over a tissue area of more than half the circumference of the penis for which a cylindrical implant of the embodiment of  FIG. 5B  is appropriate. 
       FIG. 5C  illustrates a perspective view of an embodiment where an individual one of the implants  20 ,  20 ′,  30 ,  40 ,  50 , or  60  described above are formed to provide a semi-circular or arch configuration  45  of the implant  20  of  FIG. 5A  combined with the disclosed rhomboid configuration of the skeletal framework  21  ( FIG. 2C ) providing a flexible implant  20  having a larger width at one (e.g. proximal) end of the longitudinal rods  23  of the skeletal framework  21  and a shorter length at the opposing (e.g. distal) end thereof. This provides an additional flexibility in regard to choice of size and positioning of the implant  20 , particularly if the plaques affected area of the penile tissue is irregularly shaped or has been irregularly excised and is following at least some circumferential curvature of the penile tissue. 
       FIG. 6  is a schematic cross-sectional view of a penis P including the tunica albuginea TA located around the corpora cavernosa CC of the penis P. The implant  20  is illustrated schematically and includes any of the devices described above suitably placed on the tunica albuginea TA on a side of one of the corpora cavernosa CC of the penis. The implant  20  has a semi-circular configuration  45  and/or provides a curved or crescent-shaped support for the penile tissue. Attachment mechanisms  25  attaching the implant  20  to the penis P are also shown. 
       FIG. 7  is a top view illustrating the combined rhomboid/semi-circular configuration of the embodiment of  FIG. 5C  placed on an area of one of the corpora cavernosa CC of the penis P where the Peyronie&#39;s plaques has been removed from. 
     As further illustrated in  FIG. 7 , embodiments include an implant  20  that covers at least 25% of the area of the affected side  40  of the penis P. In case not all of the area from which the Peyronie&#39;s plaque has been removed needs to be covered or supported by the implant  20 , the implant  20  suitably is configured to have a size of less than that area of excised tissue, however no less than 25% of that area. Due to the flexibility and strength of the implant  20 , the penile tissue is supported sufficiently and effectively by a less bulky implant and thereby an implant of a size less than the affected area may suffice in some cases. 
     In an aspect, the application relates to a method of treating Peyronie&#39;s disease by providing an implant in the affected penis. 
     With additional reference to  FIG. 1C , the erect penis P has a pair of corpora cavernosa CC that extend from a proximal location internal to the body up to a mid-location of the glans penis. The illustrated erect penis P includes plaques that have formed on an affected area on one side  40  of the penis P that cause the erect penis P to have an affected length La. The penis P has an unaffected side  42  that is generally opposite the affected side  40  of the penis. The unaffected side  42  of the penis P has an unaffected length of Lu. The affected side  40  of the erect penis is generally shorter than the unaffected side  42  of the erect penis such that the erect penis P presents with an undesirable curvature.  FIG. 1C  also illustrates an implant  20  to be used in the treatment of the penis P. 
     With additional reference to  FIG. 1D , the penis P includes the implant  20  subcutaneously attached to penile tissue, e.g. the tunica albuginea TA, on the affected side  40  of the penis P. The implant  20  supports the penile tissue during the erection and provides for new tissue ingrowth in the implant. 
     In one embodiment, the implant  20  is attached subcutaneously to the tunica albuginea TA of a flaccid penis P. For example, the implant  20  is provided in a variety of sizes that allows the surgeon to select an implant  20  having the appropriate size based on pre-treatment measurements, and knowing these measurements, the surgeon selects the appropriately sized implant  20  for attachment to the flaccid penis P. 
     With additional reference to  FIG. 1E , the erect penis P includes an implant  20  attached subcutaneously to the tunica albuginea on the affected side  40  of the Peyronie&#39;s afflicted penis to provide support for the penile tissue in an area from where the Peyronie&#39;s plaques has been excised, thereby straightening the penis P by obtaining an approximate equal length of both the affected and unaffected sides  40  and  42  of the penis P. Further, the flexible implant  20  allows for renewed tissue ingrowth so the penis P sustains repeated erections at a reduced risk of developing new Peyronie&#39;s plaques. 
       FIG. 8  is a block diagram  70  of one embodiment of a method of treating Peyronie&#39;s disease. The method of treatment includes at  72  evaluating the size of the Peyronie&#39;s plaques affected area of a penis. The method of treatment includes at  74  selecting an implant  20  having reinforcing components  22  providing column strength to the implant  20  and sheet components supporting the penile tissue and promoting new tissue ingrowth. The method of treatment includes at  76  subcutaneously attaching the implant to the tunica albuginea in an area of the penis where the Peyronie&#39;s plaques has been excised thereby supporting the exposed penile tissue and avoiding the curvature of the penis P. The provides at  78  supporting the penile tissue where the Peyronie&#39;s plaques have been removed. 
     EXAMPLE 
     The following example illustrates, with reference to  FIGS. 1C-1E , the surgical placement of one of the implants described above. 
     The patient is anesthetized and surgically draped to define a sterile operating field in an appropriate manner. 
     The surgeon forms a circumcoronal incision adjacent to the glans penis and a penoscrotal incision adjacent to the base of the penis P. The dartos fascia is reflected to expose the Buck&#39;s fascia, and the Buck&#39;s fascia is incised down to the tunica albuginea. 
     The surgeon excises the Peyronie&#39;s plaques, or scar tissue, from the affected area of the penis P. 
     After having evaluated and picked the required size and shape of the implant  20 , the surgeon proceeds to attach one of the above-described Peyronie&#39;s treatment implants to an exterior surface of the tunica albuginea on an affected area of the penis on which the Peyronie&#39;s plaques have been excised. 
     In one embodiment, an artificial erection is imparted to the penis P with an intracavernous injection of saline solution before attaching the implant  20  to the penis P. In other embodiments, the implant  20  is attached to the penis P while the penis is its flaccid state. 
     As a result of the excision of the Peyronie&#39;s plaques, the curvature in the penis P on the plaque&#39;s affected side is reduced or eliminated. In order to maintain the penis P in this straightened condition, the implantation and attachment of the implant  20  to the penis P, provides support to the penile tissue in at least some of the area where the plaque&#39;s have been excised and provides flexibility and strengthens the column strength of the implant  20  in a direction parallel to, or along, the penis P. In this manner, the Peyronie&#39;s treatment implant provides support and strength to the penile tissue so that the corrected curvature of the penis P can be maintained. 
     The Peyronie&#39;s treatment implant provides an implant  20  that reduces or eliminates the formation of fibrosis tissue, or Peyronie&#39;s plaque. The implant is providing a biocompatible implant that has a high degree of flexibility and increased strength. The implant does not need subsequent surgical removal or substitution because it is accepted by the user&#39;s body and furthermore has improved strength, sustainability and durability. 
     This provides an implant that allows for tissue reconstruction and is less bulky and consequently less strenuous on the surrounding tissue of the penis once implanted. The implant eliminates or reduces the physical effects of the Peyronie&#39;s disease and improves patient perception and comfort. 
     Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of medical devices as discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.