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Hydrolytic degradation of devices based on poly(DL-lactic acid) size-dependence.

The hydrolytic degradation of aliphatic polyesters derived from lactic and glycolic acids (PLA/GA polymers) has been previously shown to proceed heterogeneously in the case of large size devices, the rate of degradation being greater inside than at the surface. A qualitative model based on diffusion-reaction phenomena was proposed which accounts for the formation of the more stable outer layer. However, this model also suggested that devices with dimensions smaller than the thickness of the outer layer should degrade less rapidly than larger ones. In an attempt to check this hypothesis, 15 x 10 x 2 mm compression moulded plates, millimetric beads and submillimetric microspheres and cast films, derived from the same batch of poly (DL-lactic acid) polymer were allowed to age comparatively in isoosmolar 0.13 M phosphate buffer, pH 7.4, at 37 degrees C. Ageing of the various devices was monitored by measuring water absorption, weight loss, L-lactic acid formation, pH and molar mass changes. As expected, large size plates and millimetric beads degraded heterogeneously and much faster than homogeneously degraded submillimetric films and particles.

Absorption↗

Shielding of augmented tendon--tendon repair.

Strength and function of autogenic and xenogenic reconstruction of digital extensor tendons was examined in an ovine model. In this study, tendon-graft junctions were formed by either suture augmented with a woven polyester tube (A), or augmented and shielded from surrounding tissues by chemically-treated bovine pericardium (S). By 12 wk, both A and S sheep had returned to full range of motion. Mechanical strength of both the autograft-host and xenograft-host repair sites was similar, with a pooled strength of 131 +/- 25 N (n = 15). Similarly, the mid-portion xenograft strengths were constant at approximately 366 +/- 97 N (n = 7). In contrast, mid-portion autograft strengths decreased from 380 +/- 110 N (N = 4) to 120 +/- 66 N (n = 4) if shielding was omitted. The loss in autograft strength was attributed to loss of function associated with adhesions. The use of the augmentation device coupled with an adhesion barrier gives higher initial reconstruction strength and improved function during the host repair period up to 12 wk.

Animals↗

Occurrence of poly-D(-)-3-hydroxyalkanoates in the genus Bacillus.

A range of Bacillus strains were examined for their ability to accumulate poly-D(-)-3-hydroxyalkanoates (poly-HAKs) which are naturally occurring materials that are optically active, biodegradable thermoplastics. The organisms could produce poly-D(-)-3-hydroxybutyrate (poly-HB) up to 50% of cell dry weight. The content of poly-HB in the cells varied with the growth conditions. The addition of propionate or valerate in the culture resulted in a synthesis of poly-D(-)-3-hydroxyvalerate (poly-HV). All the strains tested had the ability to synthesize the co-polyester poly-HB-co-HV.

Alcaligenes↗

The effect of inflammatory synovial fluid on the breaking strength of new "long lasting" absorbable sutures.

The effect of inflammatory synovial fluid upon several absorbable sutures potentially useful for arthroscopic procedures, e.g., meniscus repair and shoulder stabilization, was studied by implanting lengths of these sutures into unstable, arthritic rabbit knees and testing their breaking strength after varying time periods (up to 18 weeks). Polyglyconate (Maxon) sutures retained no significant strength at 6 weeks. Polydioxanone (PDS) sutures began to lose breaking strength at 3 weeks, retained only 40% of their original strength 6 weeks after implantation, and had no measurable strength at 9 weeks. Polycaprolactone (LTS) sutures showed a slow reduction in strength and retained approximately 90% of their original breaking strength after 18 weeks of implantation. Green braided polyester (Mersiline) sutures showed no loss of breaking strength over the testing period. Measurements of inherent viscosity were made to give an indirect indication of the decline in molecular weight of these sutures. These data paralleled the breaking strength decline in every case. The surgeon selecting an absorbable suture must consider the length of time the suture will hold the target tissue. This information should be helpful to surgeons considering an absorbable suture for procedures such as meniscus repair and shoulder stabilization.

Absorption↗

Medial patellofemoral ligament reconstruction for recurrent dislocation of the patella: a preliminary report.

We present a surgical technique for the treatment of recurring dislocation of the patella. The procedure, based on Galleazzi's tenodesis of the semitendinosus, uses minimal dissection and small incisions to improve cosmetic results and speed recovery. A polyester ligament is passed through a bone tunnel at the midline of the patella and fixed at the medial condyle, thus creating a medial patellofemoral neoligament. We have reviewed the results of 30 knees in 30 patients with an average follow-up of 39 months. Twenty-five patients (83.3%) showed significant improvement of their initial complaints.

Adolescent↗

The in vivo histology of an absorbable suture anchor: a preliminary report.

Suture anchors are playing an increasingly important role in attaching tendons or ligaments to bone. Anchors are usually made of metallic or other nonbioabsorbable materials. The development of an absorbable suture anchor would provide a valuable tool for the surgeon; this characteristic would minimize the problems of anchor loosening, migration, interference with imaging studies, and the potential requirement for later implant removal. This study evaluated the in vivo histological response over time of the first generation Arthrex Expanding Suture Plug (ESP) (Arthrex Inc, Naples, FL). Suture anchors threaded with nonabsorbable No. 2 braided polyester sutures were implanted into ram femurs and removed at various intervals over a period of 12 weeks. After preparation, histological study showed a gradual healing response in the bone tract. There was no evidence of an inflammatory infiltrate or foreign-body reaction during the 12 weeks of implantation. A normal bone callus appeared at the insertion tunnel site consistent with a fracture-healing response. Later, a fibrous membrane appeared at the junction of the implant and the bone tunnel. Over the 12 week interval, there was a decrease in osteoblastic activity and the appearance of cavernous vascular spaces in the superficial portions of the membrane near the periosteum. The ESP anchor composed of poly-L-lactic acid was well tolerated in the in vivo setting. Throughout the study, no substantial acute, chronic, or foreign-body reaction was observed. These observations are consistent with the expected in vivo behavior of poly-L-lactic acid. There is no reason to believe that the ESP composed of poly-L-lactic acid should cause a foreign body reaction.

Animals↗

Sternal fixation with resorbable suture material.

The applicability of absorbable sutures for sternal closure was investigated. Heavy braided Polydioxanon (PDS Ethicon) sutures were tested in a routine fashion, as were steel wire and braided polyester. In a pilot study, 2 patients (20%) had a complete sternal dehiscence. These results forced us to abandon the project.

Bone Wires↗

Discretionary carotid patch angioplasty leads to good results.

BACKGROUND: This study evaluated the type and need for angioplasty in 253 consecutive carotid endarterectomies. METHODS: Polyester knitted gelatin sealed patch (DP) and polytetrafluoroethylene (PTFE) patches were used in, respectively, 159 and 29 patients, with 65 vessels closed primarily (no patch [NP]). RESULTS: Surgical results, estimated blood loss, and surgical time were similar in each group. Postoperative hematomas occurred in 6 DP and 3 NP patients. There were 3 strokes in the DP group. Long-term duplex evaluation was possible in 201 patients. The number of patients who had less than 15%, 15% to 50%, 50% to 79%, 80% to 99%, 100%, or an ungraded degree of narrowing were as follows for each group: DP, 117, 2, 5, 0, 1, and 2; PTFE, 18, 1, 1, 0, 0; and NP, 53, 0, 0, 0, 1. Statistical analysis failed to show any difference between groups postoperatively or in long-term follow-up evaluation. CONCLUSIONS: It appears that selective patching is safe and effective in male patients who undergo carotid endarterectomy. The type of patch material also is inconsequential. Patch type and its use should be at the surgeon's discretion.

Aged↗

A biomechanical comparison of the FasT-Fix meniscal repair suture system and the RapidLoc device in cadaver meniscus.

PURPOSE: This biomechanical study compared the fixation characteristics of horizontally or vertically implanted FasT-Fix devices (Smith & Nephew, Endoscopy Division, Andover, MA) consisting of two 5-mm PLLA suture T-bar anchors with a pretied self-sliding knot (No. 0 nonabsorbable, USP, braided polyester suture material) and the RapidLoc device (Mitek Surgical Products, Westwood, MA) consisting of a PLLA T-bar anchor or "backstop," a connecting suture (No. 2 nonbiodegradable Ethibond; Ethicon, Somerville, NJ), and a PLLA grommet, for repairing posterior third lesions in human menisci. TYPE OF STUDY: Controlled laboratory biomechanical study. METHODS: After repair of a vertical longitudinal meniscus lesion with either vertically or horizontally implanted FasT-Fix devices or RapidLoc devices, 3 groups of 6 specimens underwent cyclic loading (5 mm/minute, cycling between 5 and 50 N at 1 Hz for 500 cycles) before load to failure testing on a servo hydraulic device. One-way analysis of variance and Tukey HSD post hoc tests were used to evaluate group differences (P < .05). RESULTS: The vertical FasT-Fix device group (3.2 +/- 0.49 mm) had less displacement after cyclic testing than either the horizontal FasT-Fix (4.4 +/- 0.73 mm, P = .003) or the RapidLoc (4.6 +/- 0.22 mm, P = .002) device groups. The vertical FasT-Fix device group had greater stiffness during cyclic testing (14.4 +/- 2.1 N/mm) than the horizontal FasT-Fix (10.4 +/- 1.6 N/mm, P = .0001) or the RapidLoc (9.7 +/- 0.44 N/mm, P = .0001) device groups. During load to failure testing, the vertical FasT-Fix group (125.3 +/- 39 N) had 28% greater strength than the horizontal FasT-Fix device group (89.7 +/- 14 N, P = .02) and 30% greater strength than the RapidLoc device group (87.1 +/- 13 N, P = .028), whereas displacement and stiffness did not show statistically significant group differences. CONCLUSIONS: The vertical FasT-Fix group had superior biomechanical characteristics for meniscal fixation during cyclic and load to failure testing compared with horizontal FasT-Fix or RapidLoc devices. CLINICAL RELEVANCE: Although the RapidLoc devices provided fixation characteristics comparable to horizontally implanted FasT-Fix devices, vertically implanted FasT-Fix devices may provide superior all-inside fixation.

Absorbable Implants↗

Sutures and suture anchors--update 2006.

PURPOSE: To evaluate recently introduced sutures and suture anchors for single pull load to failure strength and failure mode. METHODS: Suture anchors were tested in fresh porcine metaphyseal cortex and cancellous troughs with the use of an established protocol. An Instron machine applied tensile loads parallel to the axis of insertion at a rate of 12.5 mm/sec until failure, and mean anchor failure strengths were calculated. The mode of failure (anchor pull-out, suture eyelet cut-out, or suture failure) was recorded. Anchors tested included the BioRaptor 2.9, BioZip, Super Revo, Impact, Allograft cortical anchor, SpiraLok, Herculon, AxyaLoop titanium anchors 3, 5, and 6.5 mm, AxyaLoop bioabsorbable anchors 3, 5, and 6.5, ParaFix titanium anchors 3, 5, and 6.5, ParaSorb BioAnchors 3, 5.5, and 6.5, and Bio-Corkscrew FT. Sutures were also tested through an established protocol for load to failure. Sutures tested consisted of Orthocord, Ultrabraid (White and CoBraid), ForceFiber, Hi-Fi, MagnumWire, and Maxbraid Polyethylene Plus. RESULTS: Mean failure loads were as follows: BioRaptor 238 N, BioZip 366 N, double-loaded Super Revo 486 N, triple-loaded Super Revo 362 N, Impact 202 N, Allograft cortical anchor 240 N, SpiraLok 289 N, Herculon 819 N, AxyaLoop titanium anchors 3.0 (335 N), 5.0 (485 N), and 6.5 mm (465 N), AxyaLoop bioabsorbable anchors 3 (143 N), 5 (395 N), and 6.5 (369 N), ParaFix titanium anchors 3 (335 N), 5 (485 N), and 6.5 (465 N), ParaSorb BioAnchors 3 (143 N), 5.5 (395 N), and 6.5 (369 N), and Bio-Corkscrew FT (260 N). The sutures all broke at the mid point of their tested strands away from the grips. Mean suture strength for No. 2 Orthocord was 92 N; for No. 2 Ultrabraid CoBraid and White, strengths were 265 N and 280 N, respectively; strength for No. 2 Force Fiber was 289 N, for No. 2 Hi-Fi 250 N, for No. 2 MagnumWire 303 N, and for No. 2 Maxbraid Polyethylene Plus 256 N. CONCLUSIONS: Newer suture products showed significant improvements in load to failure values when compared with braided polyester sutures. Higher load to failure values continue to be seen in metal versus biodegradable anchors and in screw-type versus nonscrew designs. CLINICAL RELEVANCE: Surgeons who prefer stronger sutures now have several high-strength suture options from which to choose. Most of the new anchors tested performed very well.

Animals↗

Development of guided bone regeneration membrane composed of beta-tricalcium phosphate and poly (L-lactide-co-glycolide-co-epsilon-caprolactone) composites.

To create biodegradable and thermoplastic materials for guided bone regeneration, GBR, and guided tissue regeneration, GTR, membranes, composites of beta-tricalcium phosphate, TCP, and biodegradable polyesters, poly (L-lactide-co-glycolide-co-epsilon-caprolactone), PLGC, and poly (L-lactide-co-epsilon-caprolactone), PLCL, were prepared by a heat-kneading method. The composites maintained thermoplasticity and mechanical strength by formation of a chemical interaction between Ca on TCP and C=O on the lactide segment of PLGC or PLCL. The composites also indicated composite effects in pH auto-regulation property and elongation of biodegradation period, e.g., the composites maintained their mechanical strength up to 12 weeks after soaking in both physiological and phosphate-buffered saline, and the period was sufficient time to use for GBR and GTR membranes. Animal tests for GBR indicated that the present composite membrane successfully regenerated beagles' mandible defects 10 x 10 x 10 mm3 in size. These results suggested that the TCP/PLGC bioresorbable composites could be utilized for GBR and GTR therapy.

Animals↗

The application of polyhydroxyalkanoates as tissue engineering materials.

Polyhydoxyalkanoates (PHA) are polyesters produced by microorganisms under unbalanced growth conditions. They are generally biodegradable and thermoprocessable, making them attractive as biomaterials for applications in both conventional medical devices and tissue engineering. Over the past years, PHA, particularly poly 3-hydroxybutyrate (PHB), copolymers of 3-hydroxybutyrate and 3-hydroxyvalerate (PHBV), poly 4-hydroxybutyrate (P4HB), copolymers of 3-hydroxybutyrate and 3-hydroxyhexanoate (PHBHHx) and poly 3-hydroxyoctanoate (PHO) and its composites have been used to develop devices including sutures, repair devices, repair patches, slings, cardiovascular patches, orthopedic pins, adhesion barriers, stents, guided tissue repair/regeneration devices, articular cartilage repair devices, nerve guides, tendon repair devices, bone marrow scaffolds, and wound dressings. The changing PHA compositions also allow favorable mechanical properties, biocompatibility, and degradation times within desirable time frames under specific physiological conditions. This paper reviews what have been achieved in the PHA tissue engineering area and concluded that the PHA prospective will look very bright in the near future.

3-Hydroxybutyric Acid↗

The effect of epsilon-caproyl/D,L-lactyl unit composition on the hydrolytic degradation of poly(D,L-lactide-ran-epsilon-caprolactone)-poly(ethylene glycol)-poly(D,L-lactide-ran-epsilon-caprolactone).

The degradation of P(DLAX-ran-CLY)-b-PEG-b-P(DLAX-ran-CLY)s ( P(DLAX-ran-CLY): Poly(D,L-lactide-ran-epsilon-caprolactone), PEG: Poly(ethylene glycol), X: D,L-lactyl unit fraction, Y: epsilon-caproyl unit fraction) is investigated. The fraction of DLA in the both end blocks is varied while the overall molecular weight and molecular weight of PEG are kept constant. DSC, XRD and GPC are employed to track the degradation process up to 200 days. Also the change in the surface and cross-sectional morphology is provided by SEM micro-photographs. The result of water absorption and weight loss characterization reveals that the incorporation of DLA in the polyester block could be an effective tool to facilitate degradation as well as water absorption. By tracking the change of molecular weight and polydispersity, chain scission and transport or removal of degraded product from the specimen were found to play a complex role in overall degradation.

Absorption↗

Esophageal epithelium regeneration on fibronectin grafted poly(L-lactide-co-caprolactone) (PLLC) nanofiber scaffold.

In order to mimic normal epithelium regeneration on synthetic scaffold in vitro, biodegradable elastic poly(l-lactide-co-caprolactone) (PLLC) was processed into nanofibrous scaffold using electrospinning technology. An adhesive protein, fibronectin (Fn), was grafted onto the scaffold fiber surface via a two-step reaction: polyester aminolysis followed by Fn coupling via glutaraldehyde. Tensile testing was performed to measure the effect of aminolysis on the scaffold mechanical properties. The strain decreased but the tensile strength remained almost constant after aminolysis. However, no obvious difference of the nanofiber surface morphology was found after Fn grafting using scanning electron microscopy (SEM). Porcine esophageal epithelial cells were seeded on the Fn bonded scaffold to test the cell growth promotion against the control unmodified PLLC nanofiber scaffold using tissue culture polystyrene (TCPS) plate as a reference. Anti-cytokeratin AE1/AE3 was used as the primary antibody to confirm the esophageal epithelial phenotype. SEM observation, immunostaining and Western Blotting to compare the collagen type IV synthesis showed that the Fn grafted on PLLC scaffold greatly promotes epithelium regeneration. This modified scaffold is expected to be a good candidate for functional esophagus substitutes.

Animals↗

New polymers for drug delivery systems in orthopaedics: in vivo biocompatibility evaluation.

The use of biodegradable polymers for drug delivery systems excluded the need for a second operation to remove the carrier. However, the development of an avascular fibrous capsule, reducing drug release, has raised concern about these polymers in terms of tissue-implant reaction. Five novel polymers were evaluated in vivo after implantation in the rat dorsal subcutis and compared to the reference polycaprolactone (PCL). Poly(cyclohexyl-sebacate) (PCS), poly(L-lactide-b-1,5-dioxepan-2-one-b-L-lactide) (PLLA-PDXO-PLLA), two 3-hydroxybutyrate-co-3-hydroxyvalerate copolymers (D400G and D600G), and a poly(organo)phosphazene (POS-PheOEt:Imidazole) specimens were histologically evaluated in terms of the inflammatory tissue thickness and vascular density at 4 and 12 weeks from surgery. The highest values of inflammatory tissue thickness were observed in D600G (P < 0.01), PCS (P < 0.001) and PLLA-PDXO-PLLA (P < 0.001) at 4 weeks, while POP-PheOEt:Imidazole showed the lowest value of inflammatory tissue thickness (P < 0.05) at 12 weeks. D400G, D600G, PLLA-PDXO-PPLA and POP-PheOEt:Imidazole showed higher (P < 0.001) values of vascular density near the implants in comparison to PCL at 4 weeks. Finally, D400G and D600G increased their vessel densities while POP-PheOEt:Imidazole and the synthetic polyester PLLA-PDXO-PLLA presented similar vessel density values during experimental times. These different behaviours to improve neoangiogenesis without severe inflammatory tissue-responses could be further investigated with drugs in order to obtain time-programmable drug delivery systems for musculoskeletal therapy.

Animals↗

The production of polyhydroxyalkanoates in recombinant Escherichia coli.

Polyhydroxyalkanoates, the natural polyester that many microorganisms accumulate to store carbon and reducing equivalents, have been considered as a future alternative of traditional plastic due to their special properties. In Escherichia coli, a previous non-polyhydroxyalkanoates producer, pathway engineering has been developed as a very powerful approach to set up microbial production process through the introduction of direct genetic changes by recombinant DNA technology. Various metabolic pathways leading to the polyhydroxyalkanoates accumulation with desirable properties at low-cost and high-productivity have been developed. At the same time, high density fermentation technology of E. coli provides an efficient polyhydroxyalkanoates production strategy. This review focused on metabolic engineering, fermentation and downstream process aiming to polyhydroxyalkanoates production in E. coli.

Escherichia coli↗

Biotechnological approaches for the production of polyhydroxyalkanoates in microorganisms and plants - a review.

The increasing effect of non-degradable plastic wastes is a growing concern. Polyhydroxyalkanoates (PHAs), macromolecule-polyesters naturally produced by many species of microorganisms, are being considered as a replacement for conventional plastics. Unlike petroleum-derived plastics that take several decades to degrade, PHAs can be completely bio-degraded within a year by a variety of microorganisms. This biodegradation results in carbon dioxide and water, which return to the environment. Attempts based on various methods have been undertaken for mass production of PHAs. Promising strategies involve genetic engineering of microorganisms and plants to introduce production pathways. This challenge requires the expression of several genes along with optimization of PHA synthesis in the host. Although excellent progress has been made in recombinant hosts, the barriers to obtaining high quantities of PHA at low cost still remain to be solved. The commercially viable production of PHA in crops, however, appears to be a realistic goal for the future.

Alkanes↗

Synthesis of a novel ester analog of nucleic acids bearing a serine backbone.

A novel analog of nucleic acids bearing an optically active serine ester backbone, serine-based nucleobase-linked polyester (SNE), was synthesized. Monomers containing a thymine base were synthesized from L- and D-serines. Furthermore, reaction conditions were thoroughly examined for the ester bond formation by using a new phosphonium-type condensing reagent on a solid support without racemization. The release of the dimer from the resin was also investigated using a new type of linker, which could be cleaved under neutral conditions.

Chromatography, High Pressure Liquid↗