Penile sleeve devices and penile stocking insert and methods of making the same

Abstract

A penile sleeve device (PSD) that is an implantable subcutaneous penile shaft silicone rubber apparatus which has several functions such as to elongate, thicken, harden, straighten and custom shape a penis. The PSD has an elongated main component of stretchable elastic silicone elastomer into which an inner component of a much higher durometer silicone rubber material is positioned to provide the PSD with some rigidity. The main component is the only portion in contact with the penile shaft since the inner component resides within a pocket of the main component that is formed by two layers therein. The outside surface of these layers may include folds to assist in enhancing penile girth and lengthening. A penile stocking insert is also provided for increasing the length of the penis it is flaccid or erect state using an elongated tubular body constructed from an elastic material which applies a compressive force around the penile shaft, thus elongating the length of the penis.

What is claimed is: 
     
         1 . A method for enhancing penis shape or to correct penis shape dysfunction by implanting a penile sleeve device in the subcutaneous space of a patient's penis, said method comprising:
 (a) degloving the penis by surgically exposing the subcutaneous space of the patient's penis by cutting the penile shaft skin at the circumcision line, revealing the penile shaft;   (b) obtaining measurements of the penile shaft during an induced erect penile state and well as during a flaccid state to form “penile measurements”;   (c) forming a first elongated tubular section comprising a flexible elastomer based on said penile measurements for maintaining the penis outstretched in a flaccid or erect state, said first elongated tubular section comprising a longitudinal pocket formed between an inner layer and an outer layer of said elongated tubular member and wherein said first elongated tubular section also comprises a first plurality of suture slits;   (d) forming an elongated open-tubular section, based on said penile measurements, comprising a high durometer silicone rubber material or a metal malleable alloy for providing hardness feature to said penile sleeve device, said elongated open-tubular section having a second plurality of suture holes that are configured to align with said first plurality of suture holes when said elongated open-tubular section is inserted within said longitudinal pocket to form said penile sleeve device;   (e) inserting a working end of a delivery device into an aperture within a dorsal side of said elongated open-tubular device, said aperture being accessible via a dorsal mid-line slit in said outer layer;   (f) positioning a glans gripper device through a tubular tunnel in said penile sleeve device;   (g) orienting a first end of said penile sleeve device to be aligned with the penis glans and manipulating said glans gripper device to grasp the penis glans;   (h) sliding said penile sleeve device onto and over the penis glans using said delivery device which is driven towards the pubic area while said glans gripper device pulls the penis glans in the opposite direction, until a proximal end flange of said penile sleeve device is positioned in the pubic pocket space near the pubic bone/ligament area and a tapered distal end of said penile sleeve device is positioned adjacent the coronal rim of the penis glans, at which time said delivery device is disengaged and removed and said glans gripper device releases the penis glans;   (i) inserting a marking instrument through said aligned plurality of suture slits to mark on the penile tissue the location of suture points;   (j) rolling back said tapered end of said penile sleeve device and then inserting sutures through said plurality of suture slits in said penile sleeve device and into the Tunica Albuginea and up through said plurality of slits;   (k) unrolling said tapered end of said penile sleeve device and tying said sutures to secure said penile sleeve device to the penis;   (l) regloving the penis by restoring the penile shaft skin along the penis shaft and connecting the skin at the circumcision line using sutures.   
     
     
         2 . The method of  claim 1  wherein said delivery device comprises a T-shaped device wherein said working end is at one end of a handle and is transversely positioned with respect to said handle. 
     
     
         3 . The method of  claim 2  wherein said aperture within said dorsal side of said elongated open-tubular device is a curved slit and wherein said working end comprises a member that is also curved for engaging one side of said curved slit. 
     
     
         4 . The method of  claim 3  wherein said curved member comprises a pair of curved walls that form a channel for engaging said one side of said curved slit therein. 
     
     
         5 . The method of  claim 4  wherein said handle is angled in a vertical plane with respect to said working end for permitting a user to engage said curved member against said one side of said curved slit and to slide said penile sleeve device over the penis glans and towards the pubic area and then to disengage said curved member from said curved slit once said penile sleeve device is positioned in the pubic pocket space near the pubic bone/ligament area and said tapered distal end of said penile sleeve device is positioned adjacent the coronal rim of the penis glans. 
     
     
         6 . The method of  claim 1  wherein said step of inserting sutures through said plurality of suture slits in said penile sleeve device comprises inserting a suture clip for a pair of suture slits, said suture slip straddling said pair of suture slits and against which the suture is positioned and knotted. 
     
     
         7 . The method of  claim 6  wherein said suture clip is U-shaped in cross-section having sidewalls that pass through respective ones of said pair of suture slits. 
     
     
         8 . The method of  claim 1  wherein said outer layer of said first elongated tubular section comprises distal lateral line slits, said distal lateral line slits provide access to said plurality of suture slits. 
     
     
         9 . The method of  claim 1  wherein said each of distal lateral line slits comprises a closure, said closure formed by a slit tongue element on one side of said distal lateral line slit that is received within a slit groove formed on an opposite side of said distal lateral line slit. 
     
     
         10 . The method of  claim 1  further comprising the step of placing permanent filler material around said penile sleeve device to increase penile girth.