Self-expandable biodegradable biliary stents in porcine model.

BACKGROUND: Treatment or prevention of a benign biliary tree stricture is an unresolved problem. A novel self-expandable biodegradable polydioxanon biliary stent in a porcine model was studied. MATERIALS AND METHODS: This new stent was used in 23 pigs. Feasibility and safety of surgical stenting, time of biodegradation, and histologic reaction in 2, 8, 13, and 20 wk of a follow-up were studied. All stents were inserted into a common bile duct through a duodenal papilla following small dilatation. After surgical evaluation of abdominal cavities, the pigs were sacrificed to remove common bile ducts with the stents. All bile ducts were assessed by macroscopic and histopathologic examination. RESULTS: Self-expansion was correct in all cases. Neither bile duct obstruction nor postsurgical complications were observed. Macroscopic evaluation indicated lightening of the stent color in 2 wk, a partial disintegration in 8 wk, and a complete absorption in 13 and 20 wk. Histologic evaluation in general substantiated a mild-to-moderate inflammatory reaction in the lamina propria during the whole follow up and had no clinical consequences. No cholangitis, necrosis, abscess, or excessive fibroplasia was found in a hepatoduodenal ligament. CONCLUSIONS: Our results suggest that polydioxanon biodegradable self-expanding stents seem to be useful for biliary system implantation, offer a good biocompatibility, and completely degrade within 13 wk.

Reconstruction of a quadriceps tendon tear using Polyvinylidene fluoride sutures and patellar screw fixation: A biomechanical study.

BACKGROUND: Acute quadriceps tendon tears are infrequent injuries requiring surgical treatment. Improved stability after surgical repair may allow for earlier weight-bearing and range of motion. Therefore, a new implant was tested and compared with the "gold standard", using transosseous sutures. METHODS: Quadriceps tendon tears were constructed using a cadaveric model of 12 fresh matched-pair specimens (aged 61-97; mean age: 82 years). The biomechanical testing compared non-absorbable suture anchors (Polyvinylidene fluoride) versus transosseous absorbable sutures (Polydioxanon). Following anatomic reconstruction, the repaired specimens were loaded until they failed (testing machine: Hounsfield H10KM, Redhill, United Kingdom; maximum force: 1000 N; load speed: 25 mm/min; maximum test length: 150 mm; pre-load: 5 N). Values for load until tear displacement, maximum load until complete failure of the construct (pullout or breakage of the sutures or anchors) and stiffness of the reconstruction were recorded. RESULTS: The stiffness found in the Polyvinylidene fluoride reconstruction (mean 9.83 N/mm) (standard deviation (SD) 7.75) showed a significant increase compared to the Polydioxanon reconstruction (mean 6.66 N/mm (SD 3.32); P=0.045). Transosseous fixation showed comparable results to the suture anchor system. There was no significant difference found in the maximum load to tear displacement (PVDF: 290.88 N (SD 106.01) vs. PDS: 266.75 N (SD 82.61); P=0.358). CONCLUSIONS: Using the Polyvinylidene fluoride thread showed comparable results to the established method in reconstruction of ruptured quadriceps tendon. Stiffness of the Polyvinylidene fluoride thread reconstruction was even greater than Polydioxanon thread. CLINICAL RELEVANCE: Improved stiffness may facilitate healing and is suggested as clinical relevance in reconstruction.

Role of tissue-engineered artificial tendon in healing of a large Achilles tendon defect model in rabbits.

BACKGROUND: Treatment of large Achilles tendon defects is technically demanding. Tissue engineering is an option. We constructed a collagen-based artificial tendon, covered it with a polydioxanon (PDS) sheath, and studied the role of this bioimplant on experimental tendon healing in vivo. STUDY DESIGN: A 2-cm tendon gap was created in the left Achilles tendon of rabbits (n = 120). The animals were randomly divided into 3 groups: control (no implant), treated with tridimensional-collagen, and treated with tridimensional-collagen-bidimensional-PDS implants. Each group was divided into 2 subgroups of 60 and 120 days postinjury (DPI). Another 50 pilot animals were used to study the host-implant interaction. Physical activity of the animals was scored and ultrasonographic and bioelectrical characteristics of the injured tendons were investigated weekly. After euthanasia, macro, micro, and nano morphologies and biophysical and biomechanical characteristics of the healing tendons were studied. RESULTS: Treatment improved function of the animals, time dependently. At 60 and 120 DPI, the treated tendons showed significantly higher maximum load, yield, stiffness, stress, and modulus of elasticity compared with controls. The collagen implant induced inflammation and absorbed the migrating fibroblasts in the defect area. By its unique architecture, it aligned the fibroblasts and guided their proliferation and collagen deposition along the stress line of the tendon and resulted in improved collagen density, micro-amp, micro-ohm, water uptake, and delivery of the regenerated tissue. The PDS-sheath covering amplified these characteristics. The implants were gradually absorbed and replaced by a new tendon. Minimum amounts of peritendinous adhesion, muscle atrophy, and fibrosis were observed in the treated groups. Some remnants of the implants were preserved and accepted as a part of the new tendon. CONCLUSIONS: The implants were cytocompatible, biocompatible, biodegradable, and effective in tendon healing and regeneration. This implant may be a valuable option in clinical practice.