Conventional soft-tissue reclosure methods-sutures and staples-require substantial organized-collagen content. Some tissues lack extensive intrinsic collagenous content. Wound disruption consequences range from newly closed abdominal wounds bursting open, to post-cesarean wombs splitting at delivery, to heart valves loosening. Although sutures do approach the theoretical limit of normal force transfer-cross-sectional area times compressive strength, a different paradigm-shear force transfer across the far greater surface attainable by fine fibers parallel to the potential disruptive force could exceed that theoretical limit. Capacity is now the product of frictional coefficient, existing tissue pressure, and contact area. Using a device comprising bundles of poly(ethylene terephthalate) fibers through tissue, we previously coupled muscles to devices and bones. Here we tested an analogous device for reclosing fascia-stripped abdominal wall muscles. In 28 rabbits, fascia-deprived rectus abdominus muscles were reclosed, using the experimental device or conventional sutures. Testing muscles from the 21 three-week survivors, (with closure devices retained-the usual clinical practice) demonstrated experimental failure strength which exceeded that of controls by 58%. Histologically, solid tissue elements did in-grow between fibers for an extensive tissue-prosthetic interface. Both histology and mechanical performance suggest the fiber technology presented herein surpasses conventional sutures in closure of collagen-deficient tissues.

Although it is now understood that trained skeletal muscle can generate enough steady-state power to provide significant circulatory support, there are currently no means by which to tap this endogenous energy source to aid the failing heart. To that end, an implantable muscle energy converter (MEC) has been constructed and its function has been improved to optimize durability, anatomic fit, and mechanical efficiency. Bench tests show that MEC transmission losses average less than 10% of total work input and that about 85% of this muscle power is successfully transferred to the working fluid of the pump. Results from canine implant trials confirm excellent biocompatibility and demonstrate that contractile work of the latissimus dorsi muscle-measured to 290 mJ/stroke in one dog-can be transmitted within the body at levels consistent with cardiac assist requirements. These findings suggest that muscle-powered cardiac assist devices are feasible and that efforts to further develop this technology are warranted.

Skeletal muscles have been successfully linked to power mechanical support devices acutely. However, the required load bearing muscle to prosthetic interfaces have not been consistently durable. Tissue simply may not tolerate the repetitive pressure generated, ranging to 40,000 mm Hg, when necessary forces meet the crosssectional areas accessible by suture or clamp fixation. Dramatically increasing the force transfer surface by dispersing ultrafine polymer fibers in the distal muscle substance is the principle of a coupling device termed the MyoCoupler. Earlier, effective force transfer was computationally projected and confirmed in a pilot 30 day rabbit trial, with pull-out strength several times need. This investigation tested bonding strength after longer periods and examined the postulated fiber tissue integration. Devices and controls (buttressed suture fixation alone) were implanted contralaterally in the posterior tibial muscles of 28 rabbits for up to 90 days. Of the 28 rabbits, 21 were used for bond strength testing, and 3 were used for histology. Infection or procedural error disqualified 4 of the rabbits. Pull-out strength levels at 10-30 days (n = 7), 31-60 days (n = 10), 61-90 days (n=4), and all (n=21) were, respectively, 107.1 +/- 58.1, 111.4 +/- 42.7, 97.0 +/- 21.3, and 107.2 +/- 43.9 for MyoCouplers and 58.4 +/- 19.4, 52.3 +/- 34.7, 40.5 +/- 13.0, and 52.1 +/- 26.9 for the control animals. Differences were statistically significant (one-tailed t-test for paired data) and at progressively higher standards of probability for each successive period (p < 0.05 at 10-30 days, p < 0.01 at 31-60 days, p < 0.001 at 90 days, and p < 0.00001 for all). Histology showed fibrous tissue insinuation. Of 360 random fiber surface sites, 88% were closer to fibrous tissue structures than to other fibers. These findings support the aggressive pursuit of muscle powered mechanisms for artificial hearts, assist devices, and heart wall actuators.

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