Flexor tendon healing within the tendon sheath using bioabsorbable poly-L/D-lactide 96/4 suture. A histological in vivo study with rabbits.

The bioabsorbable poly-L/D-lactide (PLDLA) 96/4 suture has good biomechanical and knot properties, and sufficient tensile strength half-life for flexor tendon repair. In the present study, the biocompatibility of PLDLA suture was compared with that of coated braided polyester suture in the rabbit flexor digitorum profundus tendon repaired within the tendon sheath. Postoperative unrestricted active mobilization was allowed. The tendons were studied histologically after 1-, 3-, 6-, 12-, 26-, and 52-week follow-ups. No differences were found in the biocompatibility between the suture materials, with only scattered multinuclear giant cells near the sutures in both groups from 6 weeks onwards. At 52 weeks, most of the PLDLA material was absorbed and the histological structure of the tendon appeared normal, whereas in the polyester repairs the suture knots filled the repair site, causing bulking of the tendon surface, and the collagen alignment appeared disoriented. The results suggest that the PLDLA 96/4 is a suitable suture material for flexor tendon repair.

Bioabsorbable poly-L/D-lactide (PLDLA) 96/4 triple-stranded bound suture in the modified Kessler repair: an ex vivo static and cyclic tensile testing study in a porcine extensor tendon model.

Previously the biomechanical properties of the bioabsorbable poly-L: /D: -lactide (PLDLA) 96/4 suture were found suitable for flexor tendon repair. In this study, three PLDLA suture strands were bound together parallel to each other side-by-side to form a triple-stranded bound suture and the modified Kessler tendon repair was performed. The biomechanical properties of the PLDLA repair in porcine extensor tendons ex vivo were investigated with static and cyclic tensile testing. In both biomechanical tests, the strength of the PLDLA repair achieved the estimated forces needed to withstand active mobilization.

Pull-out strength of multifunctional bioabsorbable ciprofloxacin-releasing polylactide-polyglycolide 80/20 tacks: an experimental study allograft cranial bone.

In this study, the pull-out forces of recently developed multifunctional bioabsorbable self-reinforced ciprofloxacin-releasing polylactide/polyglycolide (SR-PLGA+AB) 80/20 tacks were compared with plain SR-PLGA 80/20 tacks in human cadaver parietal bones. Pieces of parietal bone (approximately 6 x 20 cm) were harvested from 5 human cadavers (all were male, 29-77 years old). Fifty plain SR-PLGA tacks (diameter, 2.0 mm; length, 6.0 mm) and 50 ciprofloxacin-releasing SR-PLGA tacks of similar dimensions were applied to drill holes using a special tack shooter without tapping the drill holes. The force needed to pull the tacks from human parietal cadaver bones was measured using a universal tensile-testing machine, by tack pull-out speed of 10 mm/min. Means and SDs were calculated and analyzed using Student's t-test (SPSS version 10.0 for Windows). The pull-out forces of the ciprofloxacin-releasing and plain tacks were 147.0 +/- 5.94 and 141.4 +/- 8.97 N respectively (P = 0.14, statistically insignificant difference between the 2 groups). The cause of failure in all cases was barb breakage. Ciprofloxacin-releasing SR-PLGA 80/20 tacks seem to have a similar holding power to cranial bone as plain SR-PLGA (80/20) tacks but have additional advantage of ciprofloxacin release.

The use of biodegradable scaffold as an alternative to silicone implant arthroplasty for small joint reconstruction: an experimental study in minipigs.

Biodegradable poly-L/D-lactide (P(L/D)LA) 96/4 joint scaffold arthroplasty is a recently clinically introduced concept in the reconstruction of small joints, however its histology and function in vivo is unknown. In this experimental study on 11 minipigs the fifth metacarpophalangeal joints were reconstructed using a P(L/D)LA 96/4 joint scaffold or Swanson silicone implant. They were evaluated until 3 years. The P(L/D)LA 96/4 joint scaffold formed a porous interposition spacer, which maintained the arthroplasty space and induced fibrous tissue in-growth in situ. No differences were found in the range of motion or arthroplasty space width between the study groups. The P(L/D)LA 96/4 joint scaffold was initially filled with vascular, loose connective tissue. Along with degradation of the scaffold, the in-grown connective tissue matured and condensed turning into dense fibrous connective tissue. After 3 years, the P(L/D)LA 96/4 joint scaffold had almost completely degraded and been replaced by dense fibrous connective tissue. These findings indicate that P(L/D)LA 96/4 joint scaffold arthroplasty leads to the formation of a functional fibrous joint. The avoidance of permanent foreign material makes the biodegradable joint scaffold an attractive alternative for small joint arthroplasty.

Long-term bone tissue reaction to polyethylene oxide/polybutylene terephthalate copolymer (Polyactive) in metacarpophalangeal joint reconstruction.

The poly-L/D-lactide 96/4 joint scaffolds are used to engineer fibrous tissue joints in situ for the reconstruction of metacarpophalangeal joints. In this experimental study, a supplementary elastomeric stem made of Polyactive 1000PEO70PBT30 (a segmented block copolymer of polyethylene oxide and polybutylene terephtalate with 70/30 PEO/PBT ratio) was used to anchor the joint scaffold in the arthroplasty space. Eleven resected fifth metacarpophalangeal joints of minipig were reconstructed and evaluated radiologically and histologically for 3 years. Plain joint scaffold and Swanson silicone implant arthroplasties (11 of each) in metacarpophalangeal joints of minipig served as controls. Altogether fore limbs of eighteen minipigs were operated for the study. Deleterious tissue reaction with dramatic signs of osteolysis and inflammatory foreign-body reaction was observed around the Polyactive stems. The mean maximum diameter of the osteolytic stem cavity was statistically wider when compared to the mean maximum diameter of Swanson implant group during the first postoperative year. Numerous osteoclasts were found at the margins of the osteolytic areas. No direct bone contact could be seen. At 1 year osteoblastic regeneration and formation of new trabecular bone followed. Finally the foreign-body reaction settled, but the adjoining bones were at this stage highly sclerotic and composed of coarse trabeculae. In contrary to previous in vivo studies suggesting biocompatibility, osteoconductivity and capability to bond to bone, Polyactive 1000PEO70PBT30 stem in this setting caused massive osteolytic lesions and foreign-body reactions.

A new biodegradable braided self-expandable PLGA prostatic stent: an experimental study in the rabbit.

PURPOSE: The biodegradable PLGA (a copolymer of L-lactide and glycolide) urethral stent with a spiral configuration has been used clinically for the prevention of postoperative urinary retention after different types of thermal therapy for benign prostatic hyperplasia. A new braiding pattern for this stent has recently been developed by our group. The aim here was to investigate the in situ degradation and biocompatibility of the new braided stent in the rabbit urethra. MATERIALS AND METHODS: PLGA stents with a one-over-one braiding pattern and steel stents served as controls that were inserted into the posterior urethras of 24 male rabbits using a special delivery instrument. The animals were sacrificed after 1 week, 1 month, 2 months, or 4 months, and light microscopy and histologic analyses were performed. RESULTS: The delivery instrument worked well and cystoscopy was not needed in the insertion process. The braided PLGA stents degraded smoothly in 1 to 2 months. The metallic stents induced more epithelial hyperplasia and epithelial changes than the biodegradable stents at all time points analyzed. These differences increased during follow-up. CONCLUSION: The degradation process was well controlled and the biodegradable stents were more biocompatible than the metallic stents. The new stent can be inserted into the posterior urethra without cystoscopic aid.

Sustained release of ciprofloxacin from an osteoconductive poly(DL)-lactide implant.

BACKGROUND AND PURPOSE: Antibiotic-releasing bioresorbable implants are used for local treatment of bone infections, but most drug delivery systems release antibiotic for too short a time. METHODS: We used pellets (0.9 x 1.0 mm) made of bioabsorbable poly(DL) lactic acid matrix, ciprofloxacin (7.3 +/- 0.4 wt%), and bioactive glass microspheres of 90-125 microm (29.3 +/- 0.2 wt%). The ciprofloxacin release and antibacterial activity was measured in elution tests in vitro and local tissue concentrations were measured in rabbits. RESULTS: In elution tests in vitro, the therapeutic level (> 2 microg/mL) of ciprofloxacin was achieved within 6 h of the start of the test, and it was maintained for up to 300 days. The antibacterial activity of the antibiotic released from sterilized composites was similar to that of the unprocessed ciprofloxacin. In vivo measurements showed high local tissue concentrations (16-86 micrg/g of bone tissue) for 3 months. Compared to previous experiments on two-component polymeric matrices (PLGA or PDLLA) with ciprofloxacin alone, adding bioactive glass microspheres into the composite resulted in morphological changes that facilitated fluid intrusion into the microstructure and quickened ciprofloxacin release. INTERPRETATION: This type of composition of implant may fulfill the requirements of bone infection therapy, for sustained local release of the selected antibiotic over several months.

Drainage and antireflux characteristics of a biodegradable self-reinforced, self-expanding X-ray-positive poly-L,D-lactide spiral partial ureteral stent: an experimental study.

PURPOSE: To evaluate the drainage and antireflux characteristics of a new self-expandable self-reinforced poly-L,D-lactide partial ureteral stent (SR-PLA 96) in an experimental model. MATERIALS AND METHODS: Twelve dogs were used as experimental animals. A low-midline laparotomy and cystotomy were performed on all animals. In group A (six animals), 50-mm long SR-PLA 96 ureteral stents with a double-helical spiral design were inserted into both ureters, leaving the lower ends 2 cm above the ureterovesical junction. In group B (six animals), both ureters were stented with traditional pigtail stents (C-Flex) Double-J; Cook Urological), which were removed 8 weeks after surgery. Renal function and ureteral patency were evaluated by dynamic kidney imaging and urography examinations at 6 and 12 weeks postoperatively. The degrees of vesicoureteral reflux at two levels of the ureters and at the level of the renal pelvis were evaluated by nuclear voiding cystograms at 6 weeks. RESULTS: The partial SR-PLA 96 stent design showed more favorable antireflux properties that the Double-J stent design. The degree of vesicoureteral reflux, reflected in an increase of nuclear enhancement at 6 weeks, was lower in the distal (7.9% +/- 14.7% v 63.2% +/- 17.3%; P < 0.05) and middle (6.1% +/- 8.1% v. 45.5% +/- 19.5%; P = 0.15) levels of the ureters as well as at the level of the renal pelvis (-3.4% +/- 3.6% v 6.2% +/- 3.9%; P = 0.65) than in the Double-J-stented ureters. No significant differences in renal function or ureteral patency were observed at 12 weeks after the Double-J stents had been removed and the SR-PLA 96 stents had fragmented. CONCLUSION: A self-expandable, self-reinforced SR-PLA 96 partial ureteral stent showed more favorable antireflux properties than a Double-J stent.

In vitro and in vivo testing of bioabsorbable antibiotic containing bone filler for osteomyelitis treatment.

The use of local antibiotics from a biodegradable implant is appealing concept for treatment of chronic osteomyelitis. Our aim was to develop a new drug delivery system based on controlled ciprofloxacin release from poly(D/L-lactide). Cylindrical composite pellets (1.0 x 0.9 mm) were manufactured from bioabsorbable poly(D/L-lactide) matrix and ciprofloxacin (7.4 wt %). In vitro studies were carried out to delineate the release profile of the antibiotic and to verify its antimicrobial activity by means of MIC testing. A long-term study in rabbits was performed to validate the release of ciprofloxacin from the composite in vivo. Therapeutic level of ciprofloxacin (>2 microg/mL) was maintained between 60 and 300 days and the concentration remained below the potentially detrimental level of 20 microg/mL in vitro. The released ciprofloxacin had retained its antimicrobial properties against common pathogens. In an exploratory long-term in vivo study with three rabbits, ciprofloxacin could not be detected from the serum after moderate filling (160 mg) of the tibia (follow-up 168 days), whereas after high dosing (a total dose of 1,000 mg in both tibias) ciprofloxacin was found temporarily at low serum concentrations (14-34 ng/mL) during the follow-up of 300 days. The bone concentrations of ciprofloxacin could be measured in all samples at 168 and 300 days. The tested copolylactide matrix seems to be a promising option in selection of resorbable carriers for sustained release of antibiotics, but the composite needs modifications to promote ciprofloxacin release during the first 60 days of implantation.

Fibre reinforced bioresorbable composites for spinal surgery.

Composites containing different amounts of beta-tricalcium phosphate (beta-TCP) embedded in a poly-lactide (PLA70) matrix with and without poly-lactide (PLA96) fibre reinforcement were studied and the feasibility of using these composites in spinal fusion implants was examined. Compressive yield strength was measured in two directions: parallel to (83-97 MPa) and perpendicular to (108-123 MPa) the laminated structure of the composites. In the parallel direction, the addition of beta-TCP decreased compressive yield strength while in the perpendicular direction this was increased when compared to plain specimens (p<0.05). Fibre reinforcement had no significant effect on compressive yield strength (p<0.05), but did increase impact strength by 127-216% for notched specimens (parallel direction) and by about 65% for un-notched specimens (perpendicular direction) (p<0.05). A 24 week in vitro analysis of implant prototypes in simulated body fluid revealed a decrease in compressive yield strength, which was greater for the samples containing 50 wt.% beta-TCP than for those containing 25 wt.% beta-TCP. After 12 weeks incubation the composites retained 66-99% of their initial compressive strength, depending on composition. After 24 weeks incubation the lowest compressive strength was 51% (56 MPa: 50/50) and the highest was 94% (90 MPa: 75/25) of the initial value. Calcium phosphate precipitation on the surfaces of the materials in vitro was also observed. The initial compressive strengths of the studied composites were comparable to materials used in spinal fusion applications, but adequate strength retention behaviour needs to be confirmed before undertaking clinical experiments.

Ciprofloxacin-releasing bioabsorbable polymer is superior to titanium in preventing Staphylococcus epidermidis attachment and biofilm formation in vitro.

Antibiotic coating systems have been successfully used to prevent bacterial attachment and biofilm formation. Our purpose was to evaluate whether bioabsorbable polylactide-co-glycolide (PLGA) 80/20 on its own, and PLGA together with ciprofloxacin (PLGA+C) have any advantages over titanium in preventing Staphylococcus epidermidis attachment and biofilm formation in vitro. Cylindrical specimens of titanium, PLGA, and PLGA+C in triplicate were examined for S. epidermidis ATCC 35989 attachment and biofilm formation after incubation with a bacterial suspension of about 10(5) cfu/mL for 1, 3, 7, 14, and 21 days, using scanning electron microscopy. Growth inhibition properties of PLGA and PLGA+C cylinders were tested on agar plates. On days 1, 3, and 21, no bacterial attachment was seen in 19.5, 9.2, and 41.4% of the titanium specimens; in 18.4, 28.7, and 34.5% of the PLGA specimens; and in 57.5, 62.1, and 57.5% of the PLGA+C specimens, respectively. During the whole study period, no biofilm was observed on 74-93% of the titanium specimens, 58-78% of the PLGA specimens, and 93-100% of the PLGA+C specimens. PLGA+C showed clear bacterial growth inhibition on agar plates, while PLGA and titanium did not show any inhibition. PLGA+C bioabsorbable material was superior to titanium in preventing bacterial attachment and biofilm formation and may have clinical applicability, for example, in prevention of infection in trauma surgery or in the treatment of chronic osteomyelitis.

Fixation of distal femoral osteotomies with self-reinforced polymer/bioactive glass rods: an experimental study on rabbits.

Two self-reinforced poly(desamino tyrosyl-tyrosine ethyl ester carbonate), poly(DTE carbonate) or self-reinforced poly(DTE carbonate)/bioactive glass rods, (2 mm by 40 mm) were implanted into the dorsal subcutaneous tissue and osteotomies of the distal femur were fixed with these rods (2 mm by 26 mm) in 36 rabbits. The follow-up times varied from three to 100 weeks. After sacrifice, three-point bending and shear tests and molecular weight measurements were performed for subcutaneously placed rods. Radiological, histological, histomorphometrical, microradiographic, and oxytetracycline-fluorescence studies of the osteotomized and intact control femora were performed. The initial mechanical properties were higher with the SR-poly(DTE carbonate) rods, but the SR-poly(DTE carbonate)/bioactive glass rods lost their mechanical properties slower. At 100 weeks the bending strength had decreased to 21% of the initial value with the SR-poly(DTE carbonate) rods and to 49% with the SR-poly(DTE carbonate)/bioactive glass rods. The shear strength had decreased to 10% with the SR-poly(DTE carbonate) rods and to 23% of the initial value with the SR-poly(DTE carbonate)/bioactive glass rods. Two slight displacements and one delayed union and one failure of fixation were seen in the SR-poly(DTE carbonate) group. In the SR-poly(DTE carbonate)/bioactive glass group five delayed unions and seven slight displacements were seen. No signs of osteolysis or foreign body reactions were observed. Signs of resorption of the implants were seen at 100 weeks in the SR-poly(DTE carbonate)/bioactive glass group. The present investigation showed that the mechanical strength and fixation properties of SR-poly(DTE carbonate) and SR-poly(DTE carbonate)/bioactive glass rods are suitable for fixation of cancellous bone osteotomies in rabbits.

Strength retention properties of self-reinforced poly L-lactide (SR-PLLA) sutures compared with polyglyconate (Maxon) and polydioxanone (PDS) sutures. An in vitro study.

Recent developments in manufacturing techniques have led to the development of strong bioabsorbable materials such as self-reinforced poly L-lactide (SR-PLLA) sutures. The aim of the study was to investigate the mechanical properties of SR-PLLA sutures in comparison with polyglyconate (Maxon) and polydioxanone (PDS) sutures in vitro. Sutures made of SR-PLLA (0.3, 0.5 and 0.7 mm diameter), Maxon (0.3 and 0.5 mm diameter) and PDS (0.3 and 0.5 mm diameter) were studied by immersion in phosphate-buffered distilled water (pH 7.4) at 37 degrees C for 40 weeks. The breaking force of straight sutures and suture knots was measured. Tensile strength and percentage elongation were calculated. Means, standard deviations, differences between means, and confidence intervals for differences between means were evaluated. SR-PLLA, PDS and Maxon sutures of 0.3 and 0.5 mm diameter were of comparable initial tensile strength. Initial knot tensile strength values were lower than those of their counterpart straight sutures. Maxon sutures had lost their tensile strength by 12 weeks; PDS sutures by 20 weeks. SR-PLLA sutures of 0.3 mm diameter had a strength of 161.6 MPa and those of 0.5 mm diameter had a strength of 134 MPa at 40 weeks. The highest percentage elongation of straight sutures (62.8% and 62%) was exhibited by PDS; the lowest by SR-PLLA (35.6% and 35%). In loop tests, PDS showed the highest percentage elongation (43.7% and 58.1%) and SR-PLLA had the lowest values (19.7% and 33%). SR-PLLA sutures had the most prolonged strength retention in vitro, but the lowest elongation (elasticity). Compared with straight sutures, knots had lower tensile strength and elongation values. SR-PLLA sutures can be applied to the closure of wounds that need prolonged support, such as bone.

The effect of transforming growth factor-beta1, released from a bioabsorbable self-reinforced polylactide pin, on a bone defect.

Transforming growth factor-beta 1 (TGF-beta1)is a polypeptide growth factor which has been shown to increase bone formation in experimental studies. In this study it was combined to a bioabsorbable self-reinforced poly-LD-lactic acid fracture fixation pin. To assess the effect of TGF-beta1 on the healing of a bone defect, the pins were implanted in the rat distal femur next to a bone defect filled with a viscose cellulose sponge. The pins used in the study group (13 rats) contained 50 microg of TGF-beta1, whereas in the control group of nine rats an identical pin without the growth factor was used. In the histologic examination at 1, 3 and 6 weeks no difference was detected in the amount of bone inside the viscose cellulose sponge between the rats treated with TGF-beta1 and those with no added growth factor. At 3 weeks there was more fibroblast-rich mesenchymal tissue inside the viscose cellulose sponge in the rats treated with TGF-beta1. In the radiographic examination at 3 weeks there was an increase in the amount of new periosteal bone on the bone defect in the TGF-beta1-treated rats.

The effects of low-intensity pulsed ultrasound on bioabsorbable self-reinforced poly L-lactide screws.

The effects of low-intensity pulsed ultrasound on the mechanical and molecular properties of self-reinforced poly L-lactide (SR-PLLA) screws were studied in vitro. SR-PLLA screws of 4.5 mm diameter were exposed on low-intensity ultrasound for 1, 3. 6, 9, and 12 weeks. After exposure, the bending strength, shear strength, and molecular weight were investigated. There were no differences in the investigated properties between the ultrasound exposure and control groups. We found no evidence that low-intensity ultrasound has any effect on the mechanical or molecular properties of SR-PLLA screws in vitro. The present results suggest that biodegradable SR-PLLA fixation devices are compatible with low-intensity ultrasound in vitro.

In vitro and in vivo behavior of self-reinforced bioabsorbable polymer and self-reinforced bioabsorbable polymer/bioactive glass composites.

The aim of this study was to investigate the in vitro and in vivo properties and degradation of (1) self-reinforced (SR) lactide copolymer, P(L/DL)LA 70:30, and (2) SR composites of the same polylactide and bioactive glass 13-93. The following three polymer and polymer-bioactive glass samples were studied: SR-PLA70, SR-PLA70 + BaG15s, and SR-PLA70 + BaG20c. In vitro behavior was studied in a phosphate-buffered saline for 87 weeks at 37 degrees +/- 1 degrees C and a pH of 7.4 +/- 0.2. In vivo behavior was studied by implanting the rods in the dorsal subcutaneous tissue of rats (SR-PLA70 + BaG20c) or rabbits (SR-PLA70 and SR-PLA70 + BaG15s) for 48 weeks. The degradation of the specimens was evaluated by measuring the changes in mechanical properties, crystallinity and molecular weight of polymer, water absorption, weight loss, and structural changes. Results showed that the addition of bioactive glass filler modified the degradation kinetics and material morphology.

Platelet responses and coagulation activation on polylactide and heparin-polycaprolactone-L-lactide-coated polylactide stent struts.

Despite modern stent technology and effective antiplatelet therapy, metallic stents carry the risk of (sub)acute thrombosis. Our aim was to examine short-term differences in platelet deposition and coagulation activation between biodegradable polylactide (PLA), heparin-polycaprolactone-L-lactide-coated polylactide (hepa-P(CL95/L-LA5)-PLA), and stainless steel (SS) stent struts. Gel-filtered platelets (GFP) and platelet-rich plasma (PRP) were labeled with 10 nM (3)H-serotonin. Platelet deposition was measured after incubation of the stent struts in human serum albumin-coated wells at 37 degrees C in either GFP or PRP. Platelet morphology was studied by scanning electron microscopy (SEM). For coagulation activation, the stent struts were incubated in either PRP or platelet-poor plasma (PPP), anticoagulated with D-phenylalanyl-L-prolyl-L-arginine chloromethyl ketone (PPACK), followed by measurement of fibrinogen, thrombin time (TT), prothrombin fragment 1+2 (F1+2), and thrombin-antithrombin complex (TAT). SS showed adherence of larger amounts of GFPs than did PLA at a platelet density of 300 x 10(6)/mL (p < 0.05). Furthermore, representative SEM studies showed more platelet spreading on SS than on PLA stent struts. Between PLA and SS, coagulation activity did not differ at any assessment. Based on prolonged TT values in plasma, the heparin coating strongly inhibited coagulation (p < 0.05). The values of soluble TAT and F1+2 for PLA were similar to those of controls, i.e., to incubated suspensions without a stent strut. In conclusion, when compared with stainless steel, both PLA and hepa-P(CL95/L-LA5)-PLA appear hemocompatible as intravascular stent materials.

Bioabsorbable SR-PLGA horn stent after antegrade endopyelotomy: a case report.

PURPOSE: To evaluate the suitability of a bioabsorbable stent as a partial internal catheter after percutaneous endopyelotomy in ureteropelvic junction (UPJ) obstruction therapy. PATIENT AND METHODS: The material for the helical spiral stents was a copolymer of polylactide and glycolide (PLGA; L:G ratio 80/20). The self-reinforcement (SR) was accomplished by heating and drawing by Bionx Implants Ltd, Tampere, Finland. The stents were horn shaped, with an initial outside diameter 6 to 3.0 mm +/- 0.2 mm and a length of 90 mm. The stent was partially degraded before insertion so it would degrade faster from the distal end, proceeding gradually to the proximal end. According to in vitro estimation, the degradation time of the material was 2 to 2.5 months. The railroaded cold-knife technique was used for antegrade endopyelotomy. After relief of the UPJ obstruction, the stent was pushed to the upper ureter. RESULTS: The 37-year-old male patient had under open pyeloplasty 5 years previously. He had a pelvic stone 32 mm in diameter and tight restenosis of the UPJ. Percutaneous lithotripsy, incision of the stenosis, and application of the SR-PLGA helical horn-shaped spiral stent was without early or late complications. Eighteen months after the operation, retrograde pyelography showed the UPJ to be totally unobstructed. CONCLUSIONS: The bioabsorbable horn-shaped SR-PLGA helical spiral stent proved a suitable alternative for stenting of the UPJ after antegrade endopyelotomy, bringing a reduced need for postoperative percutaneous kidney drainage and no need for subsequent stent removal. The bioabsorbable helical stent works as a partial catheter, which prevents vesicoureteral reflux and reduces the risk of postoperative renal infection.

Interstitial laser coagulation and biodegradable self-expandable, self-reinforced poly-L-lactic and poly-L-glycolic copolymer spiral stent in the treatment of benign prostatic enlargement.

BACKGROUND AND PURPOSE: Interstitial laser coagulation of the prostate (ILCP) induces necrosis, edema, and an increased risk of postoperative urinary retention. The object here was to evaluate the efficacy, safety, and utility of a new self-expandable self-reinforced (SR) PLGA copolymer(lactic:glycolic ratio 80/20) spiral stent inserted after ILCP to promote voiding. The SR-PLGA stent has a degradation time of 2 to 2.5 months. PATIENTS AND METHODS: Fifty men with a mean age of 70.5 years (range 52-85 years), suffering from lower urinary tract symptoms secondary to benign prostatic enlargement underwent ILCP. A suprapubic catheter was inserted, ILCP performed, and an SR-PLGA 80/20 spiral stent inserted on completion of the operation. The suprapubic catheter was removed when voiding commenced. As prophylactic antibiotic, ciprofloxacin was used in a single dose before ILCP, followed by trimethoprim or nitrofurantoin for 2 weeks. RESULTS: All except three patients started to void on the first postoperative day. In two of the three cases, the stent had moved proximally and had to be relocated, whereafter voiding succeeded. The mean maximum and average flow rates increased, while DAN-PSS-1 symptom score and post voiding residual urine volume decreased statistically significantly. At 2 months, the stent was still intact in the urethra in all except three patients. At 4 months, it had been degraded into small fragments, and at 6 months, it had been completely eliminated. The only exceptions were three patients with an uncalcified piece of the stent in the bladder. Half of the patients had irritative symptoms caused at least partly by ILCP itself; 10% had asymptomatic urinary infection postoperatively. CONCLUSIONS: The self-expandable SR-PLGA copolymer stent is safe and highly biocompatible. It ensures voiding in the case of temporary obstruction caused by prostatic edema. The degradation time is long enough in all patients to cover the need for postprocedure urinary drainage.

Self-reinforced polylactide/polyglycolide 80/20 screws take more than 1(1/2) years to resorb in rabbit cranial bone.

The aim of this study was to assess tissue reactions to bioabsorbable self-reinforced polylactide/polyglycolide (SR-PLGA) 80/20 miniscrews in rabbit cranial bone. One PLGA screw was implanted on one side and one titanium screw on the other side of the sagittal suture (n = 21). Three animals were sacrificed after 2, 4, 8, 16, 24, 54, and 72 weeks. In histological examination the numbers of macrophages, giant cells, active osteoblasts, and fibrous tissue layers were assessed and degradation of the bioabsorbable screws was evaluated. After 2 weeks, macrophages were seen near the heads of both screws. After 4 and 8 weeks, the bioabsorbable screws were surrounded by fibrous tissue. Osteoblastic activity and groups of several giant cells were seen. After 24 weeks, a significant change in the morphology of the PLGA screws had occurred. Osteoblastic activity and the amount of giant cells had decreased. After 1 year, some PLGA biomaterial was still present. PLGA screws had been replaced by adipose tissue, fibrous tissue, and "foamy macrophages" that had PLGA particles inside them. After 1(1/2) years, the amount of biomaterial remaining had decreased remarkably. The particles of biomaterial were inside foamy macrophages. SR-PLGA 80/20 screws are biocompatible and have no clinically manifested complications when used in the cranial bone of rabbits. No contraindications as regards their clinical use in craniofacial surgery was found when these screws were studied in the cranial bones of rabbits.