In Vivo Efficacy of a Novel, Sutureless Coaptation Device for Repairing Peripheral Nerve Defects.

Although microsuture neurorrhaphy is the accepted clinical standard treatment for severed peripheral nerves, this technique requires microsurgical proficiency and still often fails to provide adequate nerve approximation for effective regeneration. Entubulation utilizing commercially available conduits may enhance the technical quality of the nerve coaptation and potentially provide a proregenerative microenvironment, but still requires precise suture placement. We developed a sutureless nerve coaptation device, Nerve Tape®, that utilizes Nitinol microhooks embedded within a porcine small intestinal submucosa backing. These tiny microhooks engage the outer epineurium of the nerve, while the backing wraps the coaptation to provide a stable, entubulated repair. In this study, we examine the impact of Nerve Tape on nerve tissue and axonal regeneration, compared with repairs performed with commercially available conduit-assisted or microsuture-only repairs. Eighteen male New Zealand white rabbits underwent a tibial nerve transection, immediately repaired with (1) Nerve Tape, (2) conduit plus anchoring sutures, or (3) four 9-0 nylon epineurial microsutures. At 16 weeks postinjury, the nerves were re-exposed to test sensory and motor nerve conduction, measure target muscle weight and girth, and perform nerve tissue histology. Nerve conduction velocities in the Nerve Tape group were significantly better than both the microsuture and conduit groups, while nerve compound action potential amplitudes in the Nerve Tape group were significantly better than the conduit group only. Gross morphology, muscle characteristics, and axon histomorphometry were not statistically different between the three repair groups. In the rabbit tibial nerve repair model, Nerve Tape offers similar regeneration efficacy compared with conduit-assisted and microsuture-only repairs, suggesting minimal impact of microhooks on nerve tissue.

Thermo-mechanical behavior and structure of melt blown shape-memory polyurethane nonwovens.

New processing methods for shape-memory polymers allow for tailoring material properties for numerous applications. Shape-memory nonwovens have been previously electrospun, but melt blow processing has yet to be evaluated. In order to determine the process parameters affecting shape-memory behavior, this study examined the effect of air pressure and collector speed on the mechanical behavior and shape-recovery of shape-memory polyurethane nonwovens. Mechanical behavior was measured by dynamic mechanical analysis and tensile testing, and shape-recovery was measured by unconstrained and constrained recovery. Microstructure changes throughout the shape-memory cycle were also investigated by micro-computed tomography. It was found that increasing collector speed increases elastic modulus, ultimate strength and recovery stress of the nonwoven, but collector speed does not affect the failure strain or unconstrained recovery. Increasing air pressure decreases the failure strain and increases rubbery modulus and unconstrained recovery, but air pressure does not influence recovery stress. It was also found that during the shape-memory cycle, the connectivity density of the fibers upon recovery does not fully return to the initial values, accounting for the incomplete shape-recovery seen in shape-memory nonwovens. With these parameter to property relationships identified, shape-memory nonwovens can be more easily manufactured and tailored for specific applications.

Anterior cruciate ligament fixation: is radial force a predictor of the pullout strength of soft-tissue interference devices?

BACKGROUND: In anterior cruciate ligament (ACL) reconstruction, an interference device achieves soft-tissue graft fixation by radially compressing the graft against the bone. PURPOSE: The objective of this study was to measure the radial force generated by different interference devices and evaluate the effect of this radial force on the pullout strength of graft-device constructs. STUDY DESIGN: Controlled laboratory study. METHODS: A resultant force (F(R)) was used as a representative measure of the total radial force generated. Bovine tendons were fixated in either synthetic bone or porcine tibia using one of following devices: (1) RCI titanium screw, (2) PEEK screw, (3) IntraFix sheath-and-screw device, and (4) ExoShape sheath-and-insert device. F(R) was measured while each device was inserted into synthetic bone mounted on a test machine (n=5 for each device). In a subsequent test series, graft-device constructs were loaded to failure at 50mm/min. The pullout strength was measured as the ultimate load before failure (n=10 for each device). RESULTS: The F(R) values generated during insertion into synthetic bone were 777 ± 86N, 865 ± 140N, 1313 ± 198N, and 1780 ± 255N for the RCI screw, PEEK screw, IntraFix, and ExoShape, respectively. The pullout strengths in synthetic bone for the RCI screw, PEEK screw, IntraFix and ExoShape were 883 ± 125N, 716 ± 249N, 1147 ± 142N, and 1233 ± 190N, respectively. CONCLUSIONS: These results suggest that the F(R) generated during interference fixation affects the pullout strength with sheath-based devices providing superior F(R) compared with interference screws. The use of synthetic bone was validated by comparing the pullout strengths to those when tested in porcine tibia. CLINICAL RELEVANCE: These results could be valuable to a surgeon when determining the best fixation device to use in the clinical setting.

Bearing area: a new indication for suture anchor pullout strength?

Studies performed to quantify the pullout strength of suture anchors have not adequately defined the basic device parameters that control monotonic pullout. The bearing area of a suture anchor can be used to understand and predict anchor pullout strength in a soft-bone model. First, conical-shaped test samples were varied in size and shape and tested for pullout in 5, 8, and 10 pcf sawbone models. Next, bearing area and pullout strength relationships developed from the test samples were validated against nine commercially available suture anchors, including the Mitek QuickAnchor and SpiraLok, Opus Magnum(2), ArthroCare ParaSorb, and Arthrex BioCorkscrew. The samples showed a direct correlation between bearing area and pullout strength. Increased insertion depth was a secondary condition that also increased pullout strength. The pullout strength for the suture anchors followed the predicted trends of conical devices based on their individual bearing areas. For the 5 and 8 pcf models, only two and three devices, respectively, fell outside the predicted pullout strength range by more than a standard deviation. The use of a synthetic sawbone model was validated against the pullout strength of an Arthrex Corkscrew in five fresh-frozen cadaver humeral heads. The bearing area of a suture anchor can be used to predict the pullout strength independent of design in a soft-bone model. This work helps provide a foundation to understand the principles that affect the pullout strength of suture anchors.