Fused Filament Fabrication of Prosthetic Components for Trans-Humeral Upper Limb Prosthetics

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Description
Presented below is the design and fabrication of prosthetic components consisting of an attachment, tactile sensing, and actuator systems with Fused Filament Fabrication (FFF) technique. The attachment system is a thermoplastic osseointegrated upper limb prosthesis for average adult trans-humeral amputation…

Presented below is the design and fabrication of prosthetic components consisting of an attachment, tactile sensing, and actuator systems with Fused Filament Fabrication (FFF) technique. The attachment system is a thermoplastic osseointegrated upper limb prosthesis for average adult trans-humeral amputation with mechanical properties greater than upper limb skeletal bone. The prosthetic designed has: a one-step surgical process, large cavities for bone tissue ingrowth, uses a material that has an elastic modulus less than skeletal bone, and can be fabricated on one system.

FFF osseointegration screw is an improvement upon the current two-part osseointegrated prosthetics that are composed of a fixture and abutment. The current prosthetic design requires two invasive surgeries for implantation and are made of titanium, which has an elastic modulus greater than bone. An elastic modulus greater than bone causes stress shielding and overtime can cause loosening of the prosthetic.

The tactile sensor is a thermoplastic piezo-resistive sensor for daily activities for a prosthetic’s feedback system. The tactile sensor is manufactured from a low elastic modulus composite comprising of a compressible thermoplastic elastomer and conductive carbon. Carbon is in graphite form and added in high filler ratios. The printed sensors were compared to sensors that were fabricated in a gravity mold to highlight the difference in FFF sensors to molded sensors. The 3D printed tactile sensor has a thickness and feel similar to human skin, has a simple fabrication technique, can detect forces needed for daily activities, and can be manufactured in to user specific geometries.

Lastly, a biomimicking skeletal muscle actuator for prosthetics was developed. The actuator developed is manufactured with Fuse Filament Fabrication using a shape memory polymer composite that has non-linear contractile and passive forces, contractile forces and strains comparable to mammalian skeletal muscle, reaction time under one second, low operating temperature, and has a low mass, volume, and material costs. The actuator improves upon current prosthetic actuators that provide rigid, linear force with high weight, cost, and noise.
Date Created
2017
Agent

Improving Health-Care Delivery in Low-Resource Settings With Nanotechnology: Challenges in Multiple Dimensions

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Description

In the two decades after 1990, the rates of child and maternal mortality dropped by over 40% and 47%, respectively. Despite these improvements, which are in part due to increased access to medical technologies, profound health disparities exist. In 2015,…

In the two decades after 1990, the rates of child and maternal mortality dropped by over 40% and 47%, respectively. Despite these improvements, which are in part due to increased access to medical technologies, profound health disparities exist. In 2015, a child born in a developing region is nearly eight times as likely to die before the age of 5 than one born in a developed region and developing regions accounted for nearly 99% of the maternal deaths. Recent developments in nanotechnology, however, have great potential to ameliorate these and other health disparities by providing new cost-effective solutions for diagnosis or treatment of a variety of medical conditions. Affordability is only one of the several challenges that will need to be met to translate new ideas into a medical product that addresses a global health need. This article aims to describe some of the other challenges that will be faced by nanotechnologists who seek to make an impact in low-resource settings across the globe.

Date Created
2017-03-29
Agent

Effects of Deep Brain Stimulation Amplitude on Motor Performance in Parkinson’s Disease

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Description

Background: The efficacy of deep brain stimulation (DBS) in Parkinson’s disease has been convincingly demonstrated in studies comparing motor performance with and without stimulation, but characterization of the stimulation dose-response curves has been limited.

Methods: In a series of case studies,…

Background: The efficacy of deep brain stimulation (DBS) in Parkinson’s disease has been convincingly demonstrated in studies comparing motor performance with and without stimulation, but characterization of the stimulation dose-response curves has been limited.

Methods: In a series of case studies, eight subjects with Parkinson’s disease and bilateral DBS systems were evaluated at their clinically determined stimulation (CDS) and at three reduced amplitudes, ie, approximately 70%, 30%, and 0% of the CDS (MOD, LOW, and OFF, respectively). Performance was assessed using the motor section of the Unified Parkinson’s Disease Rating Scale (UPDRS-III), which includes subscores for tremor, bradykinesia, gait, posture, and tapping. Data at the reduced settings were analyzed to determine if individual subjects demonstrated a threshold-like response, which was defined as a dose-response curve in which one decrement in stimulation accounted for ≥70% of the maximum change observed. Day-to-day variability was assessed using the CDS data from the three different days.

Results: In the dose-response curves, two subjects exhibited a threshold-like response, four exhibited a graded change, and two did not exhibit substantial changes. For some subjects, variability in CDS performance across the three days exceeded the change observed when reducing amplitude to the MOD setting. Comparisons across this set of eight subjects demonstrated that the mean UPDRS-III and all but one subscore significantly increased (performance degraded) when amplitude was reduced from CDS to the LOW and OFF conditions, but there were no significant changes when amplitude was reduced from CDS to the MOD condition.

Conclusion: Individual differences in the DBS dose-response curves may provide opportunities to optimize clinical performance. Day-to-day variability in motor performance cautions against the use of a single UPDRS measurement in clinical selection of DBS settings.

Date Created
2012-12-11
Agent

3D printed glucose monitoring sensor

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Description
The American Diabetes Association reports that diabetes costs $322 billion annually and affects 29.1 million Americans. The high out-of-pocket cost of managing diabetes can lead to noncompliance causing serious and expensive complications. There is a large market potential for a…

The American Diabetes Association reports that diabetes costs $322 billion annually and affects 29.1 million Americans. The high out-of-pocket cost of managing diabetes can lead to noncompliance causing serious and expensive complications. There is a large market potential for a more cost-effective alternative to the current market standard of screen-printed self-monitoring blood glucose (SMBG) strips. Additive manufacturing, specifically 3D printing, is a developing field that is growing in popularity and functionality. 3D printers are now being used in a variety of applications from consumer goods to medical devices. Healthcare delivery will change as the availability of 3D printers expands into patient homes, which will create alternative and more cost-effective methods of monitoring and managing diseases, such as diabetes. 3D printing technology could transform this expensive industry. A 3D printed sensor was designed to have similar dimensions and features to the SMBG strips to comply with current manufacturing standards. To make the sensor electrically active, various conductive filaments were tested and the conductive graphene filament was determined to be the best material for the sensor. Experiments were conducted to determine the optimal print settings for printing this filament onto a mylar substrate, the industry standard. The reagents used include a mixture of a ferricyanide redox mediator and flavin adenine dinucleotide dependent glucose dehydrogenase. With these materials, each sensor only costs $0.40 to print and use. Before testing the 3D printed sensor, a suitable design, voltage range, and redox probe concentration were determined. Experiments demonstrated that this novel 3D printed sensor can accurately correlate current output to glucose concentration. It was verified that the sensor can accurately detect glucose levels from 25 mg/dL to 400 mg/dL, with an R2 correlation value as high as 0.97, which was critical as it covered hypoglycemic to hyperglycemic levels. This demonstrated that a 3D-printed sensor was created that had characteristics that are suitable for clinical use. This will allow diabetics to print their own test strips at home at a much lower cost compared to SMBG strips, which will reduce noncompliance due to the high cost of testing. In the future, this technology could be applied to additional biomarkers to measure and monitor other diseases.
Date Created
2017
Agent

Adaptive Control of Ventilation Using Electrical Stimulation in a Biomechanical Model

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Description

Cervical spinal cord injury (SCI) causes loss or impairment of control of respiratory muscles. Life-sustaining ventilation can be provided by mechanical ventilators (which have numerous side effects) or open-loop electrical stimulation respiratory pacing systems.

Date Created
2015-12-18
Agent

Joint-Specific Changes in Locomotor Complexity in the Absence of Muscle Atrophy Following Incomplete Spinal Cord Injury

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Description

Background: Following incomplete spinal cord injury (iSCI), descending drive is impaired, possibly leading to a decrease in the complexity of gait. To test the hypothesis that iSCI impairs gait coordination and decreases locomotor complexity, we collected 3D joint angle kinematics and…

Background: Following incomplete spinal cord injury (iSCI), descending drive is impaired, possibly leading to a decrease in the complexity of gait. To test the hypothesis that iSCI impairs gait coordination and decreases locomotor complexity, we collected 3D joint angle kinematics and muscle parameters of rats with a sham or an incomplete spinal cord injury.

Methods: 12 adult, female, Long-Evans rats, 6 sham and 6 mild-moderate T8 iSCI, were tested 4 weeks following injury. The Basso Beattie Bresnahan locomotor score was used to verify injury severity. Animals had reflective markers placed on the bony prominences of their limb joints and were filmed in 3D while walking on a treadmill. Joint angles and segment motion were analyzed quantitatively, and complexity of joint angle trajectory and overall gait were calculated using permutation entropy and principal component analysis, respectively. Following treadmill testing, the animals were euthanized and hindlimb muscles removed. Excised muscles were tested for mass, density, fiber length, pennation angle, and relaxed sarcomere length.

Results: Muscle parameters were similar between groups with no evidence of muscle atrophy. The animals showed overextension of the ankle, which was compensated for by a decreased range of motion at the knee. Left-right coordination was altered, leading to left and right knee movements that are entirely out of phase, with one joint moving while the other is stationary. Movement patterns remained symmetric. Permutation entropy measures indicated changes in complexity on a joint specific basis, with the largest changes at the ankle. No significant difference was seen using principal component analysis. Rats were able to achieve stable weight bearing locomotion at reasonable speeds on the treadmill despite these deficiencies.

Conclusions: Decrease in supraspinal control following iSCI causes a loss of complexity of ankle kinematics. This loss can be entirely due to loss of supraspinal control in the absence of muscle atrophy and may be quantified using permutation entropy. Joint-specific differences in kinematic complexity may be attributed to different sources of motor control. This work indicates the importance of the ankle for rehabilitation interventions following spinal cord injury.

Date Created
2013-08-15
Agent

Neuromodulation of peripheral nerve excitability using ultrasound

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Description
The use of a non-invasive form of energy to modulate neural structures has gained wide spread attention because of its ability to remotely control neural excitation. This study investigates the ability of focused high frequency ultrasound to modulate the excitability…

The use of a non-invasive form of energy to modulate neural structures has gained wide spread attention because of its ability to remotely control neural excitation. This study investigates the ability of focused high frequency ultrasound to modulate the excitability the peripheral nerve of an amphibian. A 5MHz ultrasound transducer is used for the study with the pulse characteristics of 57msec long train burst and duty cycle of 8% followed by an interrogative electrical stimulus varying from 30μsecs to 2msecs in pulse duration. The nerve excitability is determined by the compound action potential (CAP) amplitude evoked by a constant electrical stimulus. We observe that ultrasound's immediate effect on axons is to reduce the electrically evoked CAP amplitude and thereby suppressive in effect. However, a subsequent time delayed increased excitability was observed as reflected in the CAP amplitude of the nerve several tens of milliseconds later. This subsequent change from ultrasound induced nerve inhibition to increased excitability as a function of delay from ultrasound pulse application is unexpected and not predicted by typical nerve ion channel kinetic models. The recruitment curve of the sciatic nerve modified by ultrasound suggests the possibility of a fiber specific response where the ultrasound inhibits the faster fibers more than the slower ones. Also, changes in the shape of the CAP waveform when the nerve is under the inhibitive effect of ultrasound was observed. It is postulated that these effects can be a result of activation of stretch activation channels, mechanical sensitivity of the nerve to acoustic radiation pressure and modulation of ion channels by ultrasound.

The neuromodulatory capabilities of ultrasound in tandem with electrical stimulation has a significant potential for development of neural interfaces to peripheral nerve.
Date Created
2016
Agent

Interconnects and packaging to enable autonomous movable MEMS microelectrodes to record and stimulate neurons in deep brain structures

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Description
Long-term monitoring of deep brain structures using microelectrode implants is critical for the success of emerging clinical applications including cortical neural prostheses, deep brain stimulation and other neurobiology studies such as progression of disease states, learning and memory, brain mapping…

Long-term monitoring of deep brain structures using microelectrode implants is critical for the success of emerging clinical applications including cortical neural prostheses, deep brain stimulation and other neurobiology studies such as progression of disease states, learning and memory, brain mapping etc. However, current microelectrode technologies are not capable enough of reaching those clinical milestones given their inconsistency in performance and reliability in long-term studies. In all the aforementioned applications, it is important to understand the limitations & demands posed by technology as well as biological processes. Recent advances in implantable Micro Electro Mechanical Systems (MEMS) technology have tremendous potential and opens a plethora of opportunities for long term studies which were not possible before. The overall goal of the project is to develop large scale autonomous, movable, micro-scale interfaces which can seek and monitor/stimulate large ensembles of precisely targeted neurons and neuronal networks that can be applied for brain mapping in behaving animals. However, there are serious technical (fabrication) challenges related to packaging and interconnects, examples of which include: lack of current industry standards in chip-scale packaging techniques for silicon chips with movable microstructures, incompatible micro-bonding techniques to elongate current micro-electrode length to reach deep brain structures, inability to achieve hermetic isolation of implantable devices from biological tissue and fluids (i.e. cerebrospinal fluid (CSF), blood, etc.). The specific aims are to: 1) optimize & automate chip scale packaging of MEMS devices with unique requirements not amenable to conventional industry standards with respect to bonding, process temperature and pressure in order to achieve scalability 2) develop a novel micro-bonding technique to extend the length of current polysilicon micro-electrodes to reach and monitor deep brain structures 3) design & develop high throughput packaging mechanism for constructing a dense array of movable microelectrodes. Using a combination of unique micro-bonding technique which involves conductive thermosetting epoxy’s with hermetically sealed support structures and a highly optimized, semi-automated, 90-minute flip-chip packaging process, I have now extended the repertoire of previously reported movable microelectrode arrays to bond conventional stainless steel and Pt/Ir microelectrode arrays of desired lengths to steerable polysilicon shafts. I tested scalable prototypes in rigorous bench top tests including Impedance measurements, accelerated aging and non-destructive testing to assess electrical and mechanical stability of micro-bonds under long-term implantation. I propose a 3D printed packaging method allows a wide variety of electrode configurations to be realized such as a rectangular or circular array configuration or other arbitrary geometries optimal for specific regions of the brain with inter-electrode distance as low as 25 um with an unprecedented capability of seeking and recording/stimulating targeted single neurons in deep brain structures up to 10 mm deep (with 6 μm displacement resolution). The advantage of this computer controlled moveable deep brain electrodes facilitates potential capabilities of moving past glial sheath surrounding microelectrodes to restore neural connection, counter the variabilities in signal amplitudes, and enable simultaneous recording/stimulation at precisely targeted layers of brain.
Date Created
2016
Agent

Biomechanical evaluation of a cervical intervertebral disc degeneration model

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Description
Introduction. Intervertebral disc degeneration (DD) is one of the most common diagnoses in patients with neck pain and contributes to worldwide disability. Despite the advances in diagnostic imaging today, little is known about functional status of cervical DD.…

Introduction. Intervertebral disc degeneration (DD) is one of the most common diagnoses in patients with neck pain and contributes to worldwide disability. Despite the advances in diagnostic imaging today, little is known about functional status of cervical DD. The purpose of this research was to 1) develop and validate an ovine model of cervical spine DD, 2) to quantify and compare the effect of disc lesions on dynamic spinal stiffness, and 3) study the effect of disc lesions on spinal accelerations and displacements during two types of spinal manipulative therapy (SMT). Methods. Fifteen sheep received surgically induced disc injury to the mid-cervical spine via scalpel wound a minimum of five months earlier and 15 sheep served as controls. All animals were biomechanically assessed at the level of the lesion using swept-sine mechanical loads from 0-20 Hz under load control to quantify dynamic dorsoventral (DV) spine stiffness (load/deformation, N/mm). The effect of disc lesion on stiffness was assessed using a one-factor repeated measures ANOVA comparing 32 mechanical excitation frequencies. Tri-axial accelerometers rigidly attached to adjacent vertebrae across the target level further evaluated the effect of disc lesion on spinal motion response during two types of SMTs. A 2x6x2 repeated measures ANOVA examined the effect of disc lesion and SMT force-time profile on spine motion response. Postmortem histological analysis graded specimens at the target site and comparison was made with descriptive statistics. Results. Annular disc tears were only observed in the disc lesion group and the mild degeneration identified was localized to the injured annular tissue that did not progress to affect other areas of the disc. No difference in overall DD grading was found among the groups. DV stiffness was significantly increased in the disc lesion group by approximately 34% at 31 of 32 frequencies examined (p<.05). SMTs resulted in decreased displacements in the disc lesion group (p<.05), and SMT type significantly influenced spinal accelerations for both the DV and axial planes. Conclusion. Disc lesions in the ovine cervical spine produce localized annular degenerative changes that increase the cervical spine dynamic stiffness and reduce its spinal motion response during manual examination and treatment that is further augmented by the force-time profile administered by the clinician.
Date Created
2015
Agent

Development and validation of a novel biomechanical testing setup and procedure for olecranon fracture fixation assessment

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Description
Olecranon fractures account for approximately 10% of upper extremity fractures and 95% of them require surgical fixation. Most of the clinical, retrospective and biomechanical studies have supported plate fixation over other surgical fixation techniques since plates have demonstrated low incidence…

Olecranon fractures account for approximately 10% of upper extremity fractures and 95% of them require surgical fixation. Most of the clinical, retrospective and biomechanical studies have supported plate fixation over other surgical fixation techniques since plates have demonstrated low incidence of reoperation, high fixation stability and resumption of activities of daily living (ADL) earlier. Thus far, biomechanical studies have been helpful in evaluating and comparing different plate fixation constructs based on fracture stability. However, they have not provided information that can be used to design rehabilitation protocols such as information that relates load at the hand with tendon tension or load at the interface between the plate and the bone. The set-ups used in biomechanical studies have included simple mechanical testing machines that either measured construct stiffness by cyclic loading the specimens or construct strength by performing ramp load until failure. Some biomechanical studies attempted to simulate tendon tension but the in-vivo tension applied to the tendon remains unknown. In this study, a novel procedure to test the olecranon fracture fixation using modern olecranon plates was developed to improve the biomechanical understanding of failures and to help determine the weights that can be safely lifted and the range of motion (ROM) that should be performed during rehabilitation procedures.

Design objectives were defined based on surgeon's feedback and analysis of unmet needs in the area of biomechanical testing. Four pilot cadaveric specimens were prepared to run on an upper extremity feedback controller and the set-up was validated based on the design objectives. Cadaveric specimen preparation included a series of steps such as dissection, suturing and potting that were standardized and improved iteratively after pilot testing. Additionally, a fracture and plating protocol was developed and fixture lengths were standardized based on anthropometric data. Results from the early pilot studies indicated shortcomings in the design, which was then iteratively refined for the subsequent studies. The final pilot study demonstrated that all of the design objectives were met. This system is planned for use in future studies that will assess olecranon fracture fixation and that will investigate the safety of rehabilitation protocols.
Date Created
2015
Agent
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