Product parameter (specification)
|
Model |
Anastomotic Nail (pcs) |
Outer Diameter (mm) |
Nail Width (mm) |
Nail Height (mm) |
|
TRW-PPH-32 |
32 |
32 |
3.8 |
3.8 |
|
TRW-PPH-34 |
34 |
34 |
3.8 |
3.8 |
|
TRW-PPH-36 |
36 |
36 |
3.8 |
3.8 |
Product introduction
Strategic Manufacturing Partnership (ODM & OEM)
We provide comprehensive ODM and OEM solutions for an extensive range of PPH (Procedure for Prolapse and Hemorrhoids) systems. Our fully integrated, one-stop service spans from initial conceptual design and precision mold engineering to large-scale production and sterile packaging. By delivering bespoke, high-performance surgical instruments, we empower global partners to enhance their brand equity and market competitiveness.
Clinical Indications & Scope
Intended Use:
The Single-Use Anorectal Stapler and its dedicated accessory suite are specifically engineered for advanced surgical interventions. The primary indication is the selective circumferential resection of redundant rectal mucosa proximal to the dentate line.
Clinical Mechanism: The PPH Procedure
The PPH technique represents a paradigm shift in proctological care. Based on the modern pathophysiological understanding of hemorrhoidal disease-which identifies the primary cause as the pathological displacement and fragmentation of the anal cushions-this procedure focuses on:
Mucosal Fixation: Re-suspending the prolapsed tissue to its anatomical position.
Vascular De-vascularization: Reducing arterial inflow to the hemorrhoidal plexus to promote natural shrinkage.
Product feature and application
Technical Specifications & Quality Standards
Staple Integrity: Staples must remain securely seated within the cartridge without structural deformity. Upon actuation, staples shall remain flush and not prematurely expose on the cartridge surface.
Safety Mechanism: The integrated safety interlock must demonstrate fluid engagement and disengagement, ensuring reliable lockout and release during the firing sequence.
Spring Kinematics: The heavy-duty return spring is calibrated for optimal elasticity, ensuring instantaneous handle reset upon release for rapid multi-step operation.
Anastomotic Performance: Engineered for precision cutting and stapling. Post-firing, staples must consistently form a perfect "B-shape" for optimal hemostasis. The annular blade must remain intact, resisting edge-rolling or chipping.
Pressure Integrity: Post-anastomosis, the stapled site must withstand an internal pressure of ≥3.6 kPa. Leakage rate is strictly controlled to ≤10 drops within a 15-second diagnostic window.
Structural Rigidity: The dilator/expander component is designed to withstand a compressive load of ≥35N without mechanical failure.
Blade Precision: The high-performance circular blade is sharpened to a medical-grade edge, with an ultra-low cutting force of ≤0.8N to minimize tissue trauma.
Material Tensile Strength: Staples are fabricated from specialized alloys with a certified tensile strength of ≥240 MPa to ensure secure tissue fixation.
Clinical Indications & Pathophysiological Basis
Application Area:
This Single-Use Anorectal Stapler system is indicated for advanced proctological interventions, specifically the selective circumferential resection of redundant rectal mucosa proximal to the dentate line.
Clinical Rationale (The PPH Technique):
Modern proctology identifies the pathological displacement of the anal cushions as a primary driver of hemorrhoidal disease. The PPH (Procedure for Prolapse and Hemorrhoids)-often referred to as Stapled Hemorrhoidopexy-addresses this through:
Anatomical Re-positioning: Lifting and securing prolapsed tissue back to its physiological position.
Ischemic De-vascularization: Interrupting the arterial flow to the hemorrhoidal plexus to facilitate natural shrinkage and symptom resolution.
Production details
Product qualification
Service
We are pleased to provide comprehensive SKD (Semi-Knocked Down) solutions, which include the supply of high-quality components as well as full-range professional technical support on your side. Our support covers detailed assembly guidance, standardized production SOPs, and professional QC protocols, all designed to assist your team in successfully establishing and implementing your own manufacturing processes in a smooth manner.
FAQ
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