Rigi10™ Malleable Penile Prosthesis
Also Known As
Inflatable Penile Prosthesis (IPP), Three-piece Inflatable Penile Prosthesis, Penile Implant
Definition
A Dynamic Inflatable Penile Prosthesis (DIPP) is an advanced type of three-piece inflatable penile prosthesis (IPP) designed to treat erectile dysfunction (ED), particularly in cases refractory to medical management 1. The term DIPP is associated explicitly with technologically enhanced devices, such as the Rigicon Infla10® series, which aim to provide a more natural feel and simulate bodily functions for an authentic erectile experience 1, 2.
The DIPP system typically consists of three main components: two inflatable cylinders implanted within the corpora cavernosa of the penis, a fluid-filled reservoir usually placed in the abdomen (e.g., submuscularly 2), and a pump discreetly positioned in the scrotum 2, 4, 6. To achieve an erection, the patient manually squeezes the pump, which transfers sterile saline fluid from the reservoir to the cylinders, causing them to inflate and become rigid. Deflation occurs via a one-touch mechanism or similar patient-friendly pump design, returning the fluid to the reservoir and the penis to a flaccid state 1, 4.
Key technological advancements incorporated into DIPPs, such as the Rigicon Infla10®, include improved, patient-friendly pumps with strain relief features to prevent tubing breakage, wider girth cylinders for enhanced rigidity and a more natural appearance, and lengthening cylinders that maintain rigidity even in more extended sizes 1. Some models, like the Infla10® Pulse™ AX, offer anatomical expansion features for both girth (up to 46 mm) and length (up to 25% relative to original length, depending on anatomy) 2. Other innovations in modern IPPs (which DIPP represents an evolution of) include flat reservoirs for improved discreteness, optimized tubing length, narrow-base cylinders, specific 0° angle designs between cylinders and tubing to aid placement, and soft molding cylinder tip redesigns that better mimic human anatomy 4. Anti-infective coatings or hydrophilic surfaces that absorb antibiotic/antifungal solutions are also crucial to reducing infection rates 4, 6.
The primary purpose of a DIPP is to provide a reliable and long-term solution for men to achieve satisfactory erections, enabling them to engage in sexual activity and improving their overall quality of life 6. These devices are designed to be invisible to observers when not in use and to provide powerful rigidity when inflated 1.
Clinical Context
- Medical History: It is crucial to thoroughly assess the patient’s symptoms (e.g., using the International Index of Erectile Function—IIEF-5), previous ED treatments, and any history of conditions like priapism (which can cause corporal fibrosis, potentially complicating surgery) or Peyronie’s disease 3.
- Surgical History: Prior major pelvic surgeries (e.g., radical prostatectomy, radical cystectomy, colorectal surgery, renal transplantation) can affect incision choices and reservoir placement strategies 3.
- Comorbidities: ED can be associated with underlying conditions like advanced cardiovascular disease, diabetes, and obesity 3. Cardiac risk stratification and medical clearance may be necessary. For diabetic patients, optimal glycemic control (e.g., HbA1c <8.5%) is important to minimize postoperative infection risk 3. Smoking cessation is also encouraged to improve wound healing 3.
- Patient Expectations: Surgeons must provide thorough counseling, emphasizing that the prosthesis aims to provide a functional erection but will not increase penile length (and may result in slight perceived shortening compared to previous natural erections). The stretched penile length preoperatively is often considered a realistic goal for postoperative erectile length 3. Discussing potential risks, benefits, and the possibility of future surgical revisions is essential for informed consent and managing expectations, significantly contributing to postoperative satisfaction 3.
- Manual Dexterity and Cognitive Ability: Patients must understand how to operate the device and have the necessary manual dexterity to manipulate the pump User Instruction Implied.
- Infection Prevention: This is paramount. Measures include preoperative parenteral antibiotics (e.g., an aminoglycoside plus a cephalosporin or vancomycin, with some recent discussions about adding antifungal prophylaxis), chlorhexidine-based skin preparation, double gloving, and the use of antibiotic-impregnated or hydrophilic-coated implants that absorb antibiotic solutions 3, 4. The “no-touch” technique may also be employed to minimize skin contact with the device 3.
- Surgical Approach: Common approaches are the penoscrotal or the infrapubic incision. The choice depends on the surgeon’s preference and the patient’s anatomy. The infrapubic approach allows for direct visualization during reservoir placement 3.
- Component Placement:
- Cylinders: After making corporotomy incisions in the tunica albuginea, the corpora cavernosa are dilated proximally to the crus and distally to the mid-glans. Care is taken to avoid urethral injury or corporal crossover. Specialized dilators may be used in cases of corporal fibrosis 3. The inflatable cylinders are then inserted into these spaces.
- Reservoir: The fluid reservoir is typically placed in the space of Retzius (preperitoneal) or, increasingly, in an ectopic submuscular location in the abdominal wall, a technique that may reduce risks of bowel or bladder injury 3. Adaptive® silicone reservoirs in some DIPP models permit underfilling to facilitate such ectopic placements 1.
- Pump: The pump mechanism is placed in a subcutaneous pocket within the scrotum for easy patient access 2, 3.
- Tubing Connections: The tubing from the cylinders, reservoir, and pump is connected, ensuring no kinks or leaks.
- Closure: Incisions are closed in layers.
- Restoration of Erectile Function: DIPPs are designed to provide reliable, patient-controlled erections, enabling satisfactory sexual intercourse 1, 3. Modern devices aim for a natural feel and appearance when flaccid and erect 1, 2.
- High Patient Satisfaction: When patients are appropriately selected and counseled, IPP surgery generally has high rates of patient and partner satisfaction 3, 4. Factors like improved pump ergonomics, better concealability, and enhanced rigidity contribute to this 1, 4.
- Durability: While mechanical failure and the need for revision surgery can occur over the long term, modern IPPs are generally durable medical devices 1, 3.
- Complications: Potential complications include infection (the most serious), pain, mechanical failure of the device, erosion of components through the skin, device malfunction, hematoma, and injury to adjacent structures like the urethra or bladder (rare) 3. Advances in device coatings and surgical techniques have aimed to minimize these risks 3, 4.
- Evolution of Technology: IPP technology, including DIPPs, continues to evolve, focusing on improving functional outcomes, ease of use, patient safety, and minimizing postoperative complications 1, 4. This includes specific designs for challenging cases like corporal fibrosis or neophallus construction in transgender patients 4.