Accepted Manuscripts

Aimee Sakes, Kevin Hovland, Gerwin Smit, Jo Geraedts and Paul Breedveld
J. Med. Devices   doi: 10.1115/1.4038561
In current bipolar electrosurgical instruments, a high frequency electrical sinusoidal wave is passed through the patient's body from an active electrode to the return electrode to cut, coagulate, or desiccate tissues. Even though current bipolar electrosurgical instruments have proven effective in minimizing blood loss, advancement is needed to allow for improved dexterity and adaptability. With current advances in 3D-print processes and its integration in the medical field it has become possible to manufacture patient- and operation-specific instruments. In this study we introduce the first 3D-printed steerable bipolar grasper (? 5 mm) for use in minimal invasive surgery. The grasper significantly improves dexterity by the addition of two planar joints allowing for ±65° for sideways and ±85° for up- and downwards movement. The joints enable a significantly higher bending stiffness, 4.0 N/mm for joint 1 and 4.4 N/mm for joint 2, than that of currently available steerable instruments. The tip consists of two metallic movable jaws that can be opened and closed with angles up to 170° and allows for grasping and coagulating of tissues; reaching tissue temperatures of over 75 °C for an activation time of ~5 s, respectively. In order to actuate the joint, tip, and electrosurgical system, as well as to tension the steering cables, a ring handle was designed. In summary, the 3D-printed steerable bipolar grasper provides the surgeon with electrosurgical capabilities, improved dexterity, improved stiffness, and the versatility that is needed to provide patient- and operation-specific care.
TOPICS: Surgery, Design, Additive manufacturing, Instrumentation, Biological tissues, Stiffness, Electrodes, Grasping, Tension, Biomedicine, Blood, Temperature, Cables, Waves
Design Innovation Paper  
F. Mark Payne, Tony Connell and Jacob Rice
J. Med. Devices   doi: 10.1115/1.4030812
Background: Tissue expanders are used in breast reconstruction after mastectomy to create a space for placement of permanent breast implants. The AeroForm™ Tissue Expander, developed by AirXpanders™ Inc., utilizes carbon dioxide released from an internal reservoir to inflate the expander. The released gas is contained within a high barrier material pre-formed into a breast shaped shell of the desired volume. During patient travel to higher altitude, a partially inflated expander will increase in volume proportionately to the gas fill volume. At volume levels near full, expansion is governed by the compliance of the inner gas barrier and silicone shell. Therefore, the assessment of the expander performance at altitude consists of the analysis of two operating regimes. The first regime is fill levels < 70% full where the implant, when exposed to cabin pressure, expands without significantly stressing the inner gas barrier. The second is fill levels ~>70% where the response of the inner gas barrier is important, both in terms of structural capability and determination of the volume increase. We assessed the impact of pressurized flight on expander performance in both operating regimes. Findings: The volume increase associated with altitude increase to 8000 feet (maximum cabin altitude per FAA) is typically within the range administered during post-operative fills of saline expanders. Although assessment must be conducted by a clinician, a patient can be typically expected to tolerate the increased volume with some minor discomfort, such as a feeling of tightness. At higher fill levels, the structural capability of shell has been demonstrated to withstand the additional pressure loading. At these fill levels, the expander does not expand as much, due to the structural restraint of the shell. To date, 7 subjects have flown with the expander in situ during clinical trials. All subjects were required to temporarily cease dosing up to two weeks prior. Flight travel was completed uneventfully and they reported discomfort levels ranging from none to moderate. The recommendation to cease dosing two weeks prior to flying was made to allow the expected 1 cc per day of CO2 permeation to occur, which will result in slight deflation to accommodate for the expansion of the CO2 when flying. As expected, subjects reported a sensation of pressure upon ascent which subsided on descent.
TOPICS: Biological tissues, Carbon dioxide, Shells, Pressure, Flight, Reservoirs, Silicones

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