Rigi10™ Malleable Penile Prosthesis
Also Known As
Fourth layer, Reinforced cylinder layer (descriptive, not official synonyms)
Definition
The Proprietary 4th Layer is an integral design feature of the cylinders in Rigicon’s Infla10® series of inflatable penile prostheses, including the Infla10® AX (Anatomical eXpansion) model.¹ It refers to an additional, distinct layer incorporated into the construction of the inflatable cylinders. This layer is designed to enhance the cylinders’ overall durability and structural integrity.¹ The primary purpose of this 4th layer is to reinforce the cylinder surface, which may contribute to increased resistance against wear and tear, and potentially reduce the likelihood of material fatigue or failure over time.¹ By improving the robustness of the cylinders, the Proprietary 4th Layer aims to contribute to the long-term performance and reliability of the penile prosthesis.¹ This feature is part of Rigicon’s broader engineering efforts to provide a durable and effective solution for men with erectile dysfunction who opt for a penile implant.¹
Clinical Context
The Proprietary 4th Layer is a component of the Rigicon Infla10® series inflatable penile prostheses, which are used in the treatment of erectile dysfunction (ED) that is chronic, organic, and has not responded to less invasive treatments.¹ These prostheses are indicated for men suitable candidates for penile prosthesis implantation.¹
Patient selection criteria typically involve a thorough urological evaluation, including medical history, physical examination, and discussion of treatment options, risks, and benefits. Candidates are generally men with ED due to conditions such as diabetes, vascular disease, prostatectomy complications, or Peyronie’s disease, for whom other therapies have failed or are contraindicated.¹ The decision to implant a penile prosthesis is made in consultation with a urologist experienced in such procedures.¹
The surgical procedure for implanting an Infla10® device, which includes cylinders with the Proprietary 4th Layer, involves placing the inflatable cylinders within the corpora cavernosa of the penis, a pump in the scrotum, and a reservoir in the abdominal space (typically in the space of Retzius).¹ The surgeon determines the specific surgical approach (e.g., penoscrotal or infrapubic) based on patient anatomy and preference.¹ The Proprietary 4th Layer, by enhancing cylinder durability, is intended to contribute to the implant’s overall longevity and mechanical reliability.¹
Expected outcomes following successful implantation include the ability to achieve a firm erection suitable for intercourse by manually operating the pump.¹ The Infla10® AX model, which features this layer, is also designed for anatomical expansion, aiming for girth and length enhancement (up to 25%) to provide a more natural feel when erect and flaccid.¹ Recovery involves a period of healing and adjustment, with specific post-operative care instructions provided by the surgeon. Success rates for inflatable penile prostheses are generally high regarding mechanical reliability and patient satisfaction, though individual results can vary and potential complications exist, as with any surgical procedure.¹ The enhanced durability offered by features like the 4th layer aims to support these positive long-term outcomes.¹