TOUCHSTONE SISO STAPLER: A New Era In Safe And Efficient Circumcision

Circumcision, the surgical removal of the foreskin, is performed worldwide for medical, cultural, and religious reasons, addressing conditions like phimosis or reducing the risk of HIV and other sexually transmitted infections by 50–60%. Traditionally, circumcision relied on conventional surgical techniques involving scalpels and sutures, which, while effective, often required skilled practitioners and carried risks of prolonged procedures and complications. The advent of assisted circumcision devices revolutionized the field, offering safer, faster, and more standardized alternatives.
The revolution began with the Shang Ring, introduced in 2005 in China and later adopted in high-HIV-prevalence regions like South Africa. This disposable, sutureless device used two concentric rings to clamp and excise the foreskin, achieving procedure times as low as 3–5 minutes and complication rates comparable to conventional methods (e.g., 0.4% minor interventions). Its success in resource-limited settings, particularly for HIV prevention, spurred further innovation in assisted circumcision devices.

Building on the “in situ” compression principle of the Shang Ring circumcision, stapler circumcision devices emerged as a significant advancement. Inspired by bowel anastomosis staplers, first developed by Hümér Hültl in 1908 for gastrointestinal surgery, these devices combine cutting and suturing in one step. The first circumcision-specific stapler, the Circular Cutter with Stapled Anastomosis for Circumcision (CCSAC), was introduced in clinical practice around 2012 in China. A study from that year reported an average procedure time of 7.7 minutes and a low complication rate of 4.8%, outperforming traditional methods in speed while maintaining safety.

Since then, the field has seen rapid innovation, with companies developing advanced stapler devices to enhance patient comfort, minimize complications, and improve cosmetic outcomes. Notable examples include the CircCurer (LangHe) and ZSR Stapler, introduced around 2019, which offer streamlined procedures and high patient satisfaction. The latest entrant, the Touchstone SISO Circumcision Stapler, represents a new pinnacle in this evolution, promising cutting-edge design and enhanced performance for both medical and elective circumcisions.

TOUCHSTONE SISO CIRCUMCISION STAPLER

History of Touchstone International Medical Science Co., Ltd.

Touchstone International Medical Science Co., Ltd., headquartered in Suzhou, China, was founded in August 2003 as a high-tech enterprise dedicated to advancing surgical stapling technology. Established during a surge in demand for minimally invasive surgical tools, Touchstone aimed to integrate cutting-edge engineering with clinical excellence to enhance patient outcomes and minimize surgical risks. The company quickly emerged as a leader in China’s medical device industry, specializing in staplers for thoracic, gastrointestinal, hepatobiliary, splenic, pancreatic, urological, and general surgeries. Its early product portfolio included intraluminal staplers, endoscopic linear cutters, linear cutting staplers, auto purse string clamps, and linear staplers, reflecting a commitment to innovation across diverse surgical applications.

In the 2010s, Touchstone expanded its reach globally, exporting products to the United States, Europe, Japan, Russia, Brazil, Canada, and Australia. Its focus on rigorous quality control, evidenced by certifications like ISO 13485, CE Mark, and FDA 510(k) clearance, ensured its devices met international standards. A landmark achievement came in September 2020 when Touchstone became the first Chinese stapling company to list on the Shanghai Stock Exchange (SHA:688013), bolstering its capacity for research and development. This milestone facilitated the company’s pursuit of innovative solutions, including its entry into the circumcision device market, driven by the global need for safe, efficient circumcision methods for medical and public health purposes, such as HIV prevention.

Building on the success of earlier circumcision staplers like the Circular Cutter with Stapled Anastomosis for Circumcision (CCSAC), introduced in 2012, Touchstone leveraged its expertise in stapling technology to develop the SISO Circumcision Stapler in 2021. This patented device, designed to surpass older models like the ZSR Stapler, represents a significant advancement in circumcision technology. The SISO (Smooth In, Smooth Out) Stapler enhances surgical precision, patient comfort, and cosmetic outcomes through features like mega-windows for visual control, a segregated gasket for optimized hemostasis, a discharging channel to reduce edema, B-shape staples for uniform wound closure, and a safety lock to prevent misfiring. Registered with Australia’s Therapeutic Goods Administration (TGA) on June 9, 2021, as a Class IIa medical device and approved by Singapore’s Health Sciences Authority, the SISO Stapler is tailored for outpatient procedures under local anesthesia, taking approximately 10 minutes with recovery times of 4–5 days for return to daily activities.

Elevating Circumcision: How the Touchstone SISO Stapler Sets a New Benchmark

The Touchstone SISO (Smooth In, Smooth Out) Circumcision Stapler represents a pinnacle of innovation in circumcision technology, delivering superior outcomes compared to traditional surgical methods and earlier stapler devices like the ZSR or CircCurer. Introduced in 2021 by Touchstone International Medical Science Co., Ltd., this patented, disposable device streamlines the circumcision process, reducing procedure times to approximately 10 minutes under local anesthesia while enhancing patient comfort, safety, and cosmetic results. Its advanced design, registered with Australia’s Therapeutic Goods Administration (TGA) and Singapore’s Health Sciences Authority, addresses common challenges of circumcision, such as postoperative complications and prolonged recovery. The SISO Stapler’s unique components work synergistically to optimize surgical precision and patient experience.

Mega-Window for Precision: The SISO Stapler features a mega-window design that provides clear visualization of the foreskin during the procedure. This window allows surgeons to precisely adjust the foreskin under direct visual control, ensuring accurate alignment and excision. Unlike traditional methods, which rely heavily on the surgeon’s experience to avoid uneven cuts, the mega-window minimizes errors, resulting in consistent, aesthetically pleasing outcomes.
Segregated Gasket for Enhanced Healing: The segregated gasket is a critical innovation that improves hemostasis and accelerates wound healing. By self-adjusting to the foreskin’s thickness, it ensures optimal compression, reducing intraoperative bleeding and postoperative complications like hematoma (reported at less than 5% in stapler studies). The gasket’s design also facilitates clean separation from the foreskin, minimizing tissue trauma and patient discomfort. This leads to faster recovery times, with patients typically resuming daily activities within 4–5 days, compared to 7–10 days for conventional circumcision.

SISO System for Comfort: The Smooth In, Smooth Out (SISO) system is engineered to reduce discomfort during device placement. The metal concave seat is gently positioned under the foreskin and over the glans penis, minimizing tissue manipulation and patient pain. This contrasts with earlier staplers, where insertion could cause discomfort due to less refined designs. The SISO system’s ergonomic approach enhances patient tolerance, making it ideal for outpatient settings and improving overall satisfaction rates, which studies report as exceeding 95% for stapler-based circumcisions.
Discharging Channel to Reduce Edema: Postoperative edema, a common issue in circumcision, is significantly mitigated by the SISO Stapler’s discharging channel. This feature promotes fluid drainage, reducing swelling that can delay healing or cause discomfort. Compared to traditional methods, where edema affects up to 10% of patients, the SISO Stapler’s design lowers this risk, contributing to a smoother recovery and fewer follow-up visits. Patients experience less postoperative pain, enhancing the device’s appeal for both medical and elective procedures.

B-Shape Staple for Optimal Closure: The B-shape staple design ensures precise firing and uniform staple formation, creating a secure, even wound closure. This reduces the risk of wound dehiscence (reported at 1–2% in stapler studies) and enhances cosmetic outcomes by minimizing scarring.

Safety Lock for Reliability: The inclusion of a safety lock prevents misfiring, a potential issue in earlier stapler models. This mechanism ensures the device activates only when correctly positioned, safeguarding against procedural errors that could lead to complications like incomplete excision or tissue damage.

Together, these features make the Touchstone SISO Circumcision Stapler a superior choice, offering unmatched precision, reduced complications, and faster recovery, setting a new standard in circumcision technology.

Consultation for Touchstone SISO Circumcision Stapler Procedure

Your circumcision journey begins with a focused consultation to ensure a safe, tailored procedure using the Touchstone SISO Stapler. Our doctor will review your medical history and discuss indications for circumcision, such as phimosis, infections, or elective reasons. A physical examination will confirm the diagnosis and check for contraindications, like severe scarring. Precise measurements will be taken to select the optimal SISO Stapler size, minimizing discomfort and complications while promoting a smooth 4–5 day recovery. This 15-minute consultation includes preoperative guidance and addresses your questions, ensuring confidence in the procedure’s safety and cosmetic outcomes.

Pre-Procedure Preparation for Touchstone SISO Circumcision Stapler

To ensure maximum comfort during the Touchstone SISO Circumcision Stapler procedure, we employ a dual anesthesia approach. First, a numbing cream is applied to the foreskin and left for 15–20 minutes to take effect, then gently removed. Next, local anesthesia is administered via a dorsal penile nerve block and a ring block, targeting the treatment area to minimize discomfort. This combined technique effectively reduces pain, allowing you to remain awake and comfortable throughout the 10–15-minute outpatient procedure. You’ll be informed at each step to ensure a relaxed experience, with the SISO Stapler’s design further enhancing precision and ease.

Performing the Touchstone SISO Stapler Circumcision

Once the anesthesia has taken effect, the Touchstone SISO Circumcision Stapler procedure begins. This streamlined, 10–15-minute outpatient process leverages the device’s advanced design to ensure precision, minimal discomfort, and optimal cosmetic outcomes. The steps are as follows:

• Preparation: The foreskin is gently retracted to expose the glans penis, allowing clear access to the treatment area. The surgical site is cleaned and sterilized to maintain a hygienic environment, reducing the risk of infection.
• Dorsal Slit (if needed): In cases where the foreskin is tight or cannot be fully retracted, a small dorsal slit is made to facilitate placement of the device.
• Placement of Concave Seat: The metal concave seat, a protective component of the SISO system, is carefully placed over the glans penis. This shields the glans from unintended injury during the procedure, enhancing safety and patient comfort.
• Foreskin Positioning: The foreskin is repositioned over the concave seat and secured in place. The mega-window allows the surgeon to visually confirm proper alignment, ensuring the foreskin is evenly distributed for a precise cut and optimal cosmetic result.
• Stapler Placement: The SISO Stapler is positioned over the concave seat, with its safety lock engaged to prevent misfiring.
• Cutting and Stapling: Upon activation, the stapler simultaneously excises the foreskin and applies a circular row of B-shaped staples to seal the wound edges. This single-step process, completed in seconds, minimizes bleeding and ensures uniform closure, reducing complications like wound dehiscence (reported at 1–2% in stapler studies).

Aftercare for Touchstone SISO Circumcision Stapler Procedure

After the Touchstone SISO Circumcision Stapler procedure, a sterile bandage is applied to protect the surgical site and reduce infection. Patients are monitored for 10–15 minutes before discharge with concise aftercare instructions. Light activities can resume within 1–2 days, with normal routines, like work or school, possible in 4–5 days. Avoid strenuous activities for 4–6 weeks. Staples would start to fall off naturally within 10–14 days; some require removal at a follow-up visit. Full healing occurs in 4–6 weeks.

Post-Procedure Care for Touchstone SISO Circumcision Stapler

To ensure optimal healing after the Touchstone SISO Circumcision Stapler procedure, patients can resume light daily activities, such as walking or desk work, on the same day with minor restrictions. To keep the sterile bandage clean and dry, avoid showering for the first 3 days, as a soaked or soiled dressing increases infection risk (less than 5% incidence). If the bandage detaches before the scheduled day-3 follow-up, patients should return to the clinic promptly for reapplication. Normal showering can resume after the bandage is removed on day 3, but the wound must be gently patted dry after showering or urination to minimize infection risk.
Strenuous activities, including exercise and heavy lifting, and sexual intercourse should be avoided for 4–6 weeks to prevent staple disruption and support complete healing. Most patients achieve full recovery with minimal scarring within this period.

Potential Complications of the Touchstone SISO Circumcision Stapler

The Touchstone SISO Circumcision Stapler is engineered to reduce complications, offering a safer and faster alternative to traditional circumcision methods. However, as with any surgical procedure, there are potential risks. Below, complications are categorized based on their likelihood, informed by studies on circumcision staplers (e.g., 4.8% complication rate in 2012 CCSAC study) and the SISO Stapler’s design, which minimizes issues like bleeding and edema.

Likely to Happen (5-10% of Cases)

These complications are relatively common but typically mild and manageable with proper care or minor intervention.

• Postoperative Edema (Swelling): Temporary swelling around the surgical site is common due to tissue manipulation. The SISO Stapler’s discharging channel reduces edema compared to traditional methods, but mild swelling may persist for 3–7 days, resolving with rest and proper wound care.
• Mild Pain or Discomfort: Patients may experience mild pain at the incision site, particularly in the first 1–3 days. This is effectively managed with over-the-counter analgesics, as the SISO system minimizes tissue trauma.

Rarely Happen (Less than 1% of Cases)

These complications are uncommon, occurring in a small percentage of patients, and are typically resolved with medical intervention or follow-up care.

• Wound Dehiscence: Partial separation of the wound edges (1% incidence in stapler studies) may occur if staples are dislodged early due to physical strain. The SISO Stapler’s B-shape staples and uniform closure reduce this risk, but patients must avoid strenuous activities for 4–6 weeks.
• Infection: Infection at the surgical site is rare (<1%) with proper hygiene and sterile technique. Keeping the bandage dry and cleaning the wound as instructed minimizes this risk.
• Hematoma: Localized bleeding under the skin (<1%) may occur.
• Delayed Staple Removal: In rare cases (<1%), some staples may not fall off naturally by 4 weeks, requiring manual removal at a follow-up visit. This is typically painless and straightforward.
• Cosmetic Irregularities: Uneven scarring or slight asymmetry (<1%) may occur, though the mega-window and precise staple placement of the SISO Stapler minimize aesthetic issues compared to traditional circumcision.
• Device Misfiring or Malfunction: Extremely rare (<0.5%) due to the safety lock, which prevents improper activation. Any malfunction would be addressed immediately during the procedure. Patients are advised to follow aftercare instructions, attend follow-up visits (typically on day 3 and month 1), and report unusual symptoms like severe pain or excessive swelling. The Touchstone SISO Stapler’s design significantly reduces complication rates, ensuring a safer procedure with high patient satisfaction (>95% in stapler studies).