Abstract: The present disclosure provides a device configured to be positioned within a prosthetic socket. The device includes a tether having a first end and a second end opposite the first end. The first end of the tether is configured to be coupled to a prosthetic liner. The device also includes a spool fixed with respect to the prosthetic socket. The second end of the tether is coupled to the spool. The device also includes a motor and a battery configured to provide power to the motor. The device also includes a coupling mechanism configured to transition from a first position in which the spool is only able to rotate in a first direction to a second position in which the spool is able to rotate in the first direction and a second direction. The device also includes a release actuator positioned on an exterior of the prosthetic socket. Actuation of the release actuator causes the coupling mechanism to transition from the first position to the second position.

Abstract: The disclosure provides example apparatus and methods for automatically adjusting a socket size of a prosthesis. The apparatus includes (a) the prosthesis having a socket configured to receive a limb, (b) a first opening in a socket wall, (c) a first panel aligned with the first opening, (d) a first actuator coupled to the first panel and to the prosthesis, the first actuator is configured to advance and retract the first panel, (e) a first sensor coupled to the socket wall and configured to obtain limb-to-socket gap data, and (f) a processor coupled to the first actuator and the first sensor, wherein the processor is configured (i) to receive the limb-to-socket gap data, (ii) to determine a socket-size adjustment based on the limb-to-socket gap data and a predetermined socket-fit value, (iii) to generate and (iv) to send a command with the socket-size adjustment to the first actuator.

Abstract: Systems, methods, and software are provided for assessing manufacturing errors of a prosthetic socket to facilitate a clinical assessment of the socket. The embodiments disclosed herein may align and compare a manufactured socket shape to a desired socket shape to determine whether clinically significant errors are present in the manufactured socket. A mean radial error (MRE) may be calculated and compared to a set threshold. If the MRE falls below the threshold an interquartile range (IQR) may be calculated and compared to an IQR threshold. If the IQR falls below the IQR threshold, surface normal angle errors (SNAE) may be calculated and plotted to the surface model. If the SNAE plot does not include closed contour regions, the socket may proceed to patient fitting. If the MRE or IQR thresholds are exceeded, or if the SNAE plot indicates closed contour regions, the socket may be reshaped accordingly, prior to fitting.

Abstract: The present invention generally relates to prosthetic socket accommodation systems. In some embodiments a prosthetic socket accommodation system may be configured to automatically adjust the accommodation system in response to user activities. In some embodiments, a controller of the prosthetic socket accommodation system may be customized for a prosthetics user based on an activity volume profile of the prosthetics user. The activity volume profile may correspond to a residual limb fluid volume response to prosthetics user activity. In some embodiments, a controller of a socket accommodation system may be configured to control pistoning during prosthetic socket use. Some embodiments are related to sensors for identifying prosthetics user activity. In some embodiments a three-axis sensor may be used to identify prosthetics user activity. In some embodiments a socket proximity sensor comprising an infrared sensor may be used to detect socket donning and doffing by the prosthetics user.

Abstract: An electrospinning apparatus and methodology is described that produces medical devices, such as scaffolds that induce the formation of a natural fibrous structure (primarily collagen and elastin) in a tissue-engineered medical device. The apparatus uses collection surfaces designed to manipulate or change the electrostatic field so that the electrospun fibers are arranged in desirable patterns that are similar to or mimic the fibrillar structure of an animal tissue. The manipulation results in fibers that are preferentially oriented in a predefined pattern. In addition, the interfiber space between the fibers and the fiber diameter are consistently within a predefined range. Using these techniques in conjunction with controlling polymer properties enables the production of a scaffold that has the structural and mechanical characteristics similar to the native tissue.

Abstract: Changes in the volume of residual limbs on which prosthetic sockets are worn can be measured based on bioimpedance measurements along one or more segments of the limb. A current at an appropriate frequency (e.g., in the range from 1 kHz to 1 MHz) is injected at two current electrodes that contact the skin of the residual limb. The voltage at the voltage electrodes disposed between the current electrodes is measured and using an appropriate model, the change in the segmented volume of the limb can be determined during periods of different activity and at different times during the day. This information can be used for assessing the fit of the socket and can also provide a feedback signal for automatically controlling volume management devices, to ensure a more comfortable fit when the volume of the limb is changing.

Abstract: Systems, methods, and software are provided for modifying a prosthetic socket to better fit a residual limb of a patient. The embodiments disclosed herein may align and compare a first shape corresponding to an interior surface of the prosthetic socket or a residual limb shape to a second shape corresponding to a desired socket shape or a rectified residual limb shape. A socket insert or pad may be manufactured per the comparison. The socket insert or pad may be configured to be affixable within the patient's prosthetic socket to modify the interior surface of the prosthetic socket such that the modified prosthetic socket provides a better fit to the residual limb of the patient.

Abstract: For use in connection with evaluating prosthetic sockets (and other objects) designed and fabricated with computer aided design and manufacturing software, the shape of a socket is accurately scanned and digitized. The scanned data are then compared to either an electronic shape data file, or to the shape of another socket, a positive model of a residual limb (or socket), or a residual limb. Differences detected during the comparison can then be applied to revise the design or fabrication of the socket, to more accurately achieve a desired shape that properly fits the residual limb of a patient and can be used to solve the inverse problem by correcting for observed errors of a specific fabricator before a socket is produced. The digitizing process is implemented using a stylus ball that contacts a surface of the socket to produce data indicating the three-dimensional shape of the socket.

Abstract: Changes in the volume of residual limbs on which prosthetic sockets are worn can be measured based on bioimpedance measurements along one or more segments of the limb. A current at an appropriate frequency (e.g., in the range from 1 kHz to 1 MHz) is injected at two current electrodes that contact the skin of the residual limb. The voltage at the voltage electrodes disposed between the current electrodes is measured and using an appropriate model, the change in the segmented volume of the limb can be determined during periods of different activity and at different times during the day. This information can be used for assessing the fit of the socket and can also provide a feedback signal for automatically controlling volume management devices, to ensure a more comfortable fit when the volume of the limb is changing.

Abstract: Changes in the volume of residual limbs on which prosthetic sockets are worn can be measured based on bioimpedance measurements along one or more segments of the limb. A current at an appropriate frequency (e.g., in the range from 1 kHz to 1 MHz) is injected at two current electrodes that contact the skin of the residual limb. The voltage at the voltage electrodes disposed between the current electrodes is measured and using an appropriate model, the change in the segmented volume of the limb can be determined during periods of different activity and at different times during the day. This information can be used for assessing the fit of the socket and can also provide a feedback signal for automatically controlling volume management devices, to ensure a more comfortable fit when the volume of the limb is changing.

Abstract: An electrospinning apparatus and methodology is described that produces medical devices, such as scaffolds that induce the formation of a natural fibrous structure (primarily collagen and elastin) in a tissue-engineered medical device. The apparatus uses collection surfaces designed to manipulate or change the electrostatic field so that the electrospun fibers are arranged in desirable patterns that are similar to or mimic the fibrillar structure of an animal tissue. The manipulation results in fibers that are preferentially oriented in a predefined pattern. In addition, the interfiber space between the fibers and the fiber diameter are consistently within a predefined range. Using these techniques in conjunction with controlling polymer properties enables the production of a scaffold that has the structural and mechanical characteristics similar to the native tissue.

Abstract: An electrospinning apparatus and methodology is described that produces medical devices, such as scaffolds that induce the formation of a natural fibrous structure (primarily collagen and elastin) in a tissue-engineered medical device. The apparatus uses collection surfaces designed to manipulate or change the electrostatic field so that the electrospun fibers are arranged in desirable patterns that are similar to or mimic the fibrillar structure of an animal tissue. The manipulation results in fibers that are preferentially oriented in a predefined pattern. In addition, the interfiber space between the fibers and the fiber diameter are consistently within a predefined range. Using these techniques in conjunction with controlling polymer properties enables the production of a scaffold that has the structural and mechanical characteristics similar to the native tissue.

Abstract: In one aspect the present invention provides medical devices 10 that each include a plurality of fibers 22, substantially all of the plurality of fibers 22 each including a portion having a maximum diameter of at least five micrometers, wherein substantially all of fibers 22 form a layer on at least one external surface of medical device 10. In another aspect, the present invention provides methods of manufacturing medical devices 10, the methods including the steps of: (a) applying a layer comprising a plurality of fibers 22 to at least one surface of medical device 10; and (b) matching the value of the Young's modulus of the layer to +/?35% (in some embodiments to +/?20%) of the value of the Young's modulus of an animal tissue.

Abstract: An electrospinning apparatus and methodology is described that produces medical devices, such as scaffolds that induce the formation of a natural fibrous structure (primarily collagen and elastin) in a tissue-engineered medical device. The apparatus uses collection surfaces designed to manipulate or change the electrostatic field so that the electrospun fibers are arranged in desirable patterns that are similar to or mimic the fibrillar structure of an animal tissue. The manipulation results in fibers that are preferentially oriented in a predefined pattern. In addition, the interfiber space between the fibers and the fiber diameter are consistently within a predefined range. Using these techniques in conjunction with controlling polymer properties enables the production of a scaffold that has the structural and mechanical characteristics similar to the native tissue.

Abstract: Changes in the volume of residual limbs on which prosthetic sockets are worn can be measured based on bioimpedance measurements along one or more segments of the limb. A current at an appropriate frequency (e.g., in the range from 1 kHz to 1 MHz) is injected at two current electrodes that contact the skin of the residual limb. The voltage at the voltage electrodes disposed between the current electrodes is measured and using an appropriate model, the change in the segmented volume of the limb can be determined during periods of different activity and at different times during the day. This information can be used for assessing the fit of the socket and can also provide a feedback signal for automatically controlling volume management devices, to ensure a more comfortable fit when the volume of the limb is changing.

Abstract: An approach is described for identifying sites of imminent skin breakdown in amputee prosthesis users. Thermal recovery time (TRT) for a limb is optically determined using an infrared camera. TRT is the time interval for the temperature of the skin to achieve 70% of its maximum value during a 10-minute recovery period after a subject has completed a standing/walk-in-place procedure. A limb tolerance map is produced in which 5×5 pixel squares are colored to indicate their TRT and labeled to indicate a temperature vs. time curve (indicative of blood flow characteristics) for the square. TRT data can also be used for prosthetic fitting and socket replacement, by locating tolerant/intolerant regions on a limb and providing a visual “limb tolerance map” for a proposed socket design and applied to other areas, such as the design of shoes for patients with insensate feet, cushions for wheelchair users, and mattresses for bedridden patients.

Abstract: For use in connection with evaluating prosthetic sockets (and other objects) designed and fabricated with computer aided design and manufacturing software, the shape of a socket is accurately scanned and digitized. The scanned data are then compared to either an electronic shape data file, or to the shape of another socket, a positive model of a residual limb (or socket), or a residual limb. Differences detected during the comparison can then be applied to revise the design or fabrication of the socket, to more accurately achieve a desired shape that properly fits the residual limb of a patient and can be used to solve the inverse problem by correcting for observed errors of a specific fabricator before a socket is produced. The digitizing process is implemented using a stylus ball that contacts a surface of the socket to produce data indicating the three-dimensional shape of the socket.

Abstract: In one aspect, the invention provides methods for forming a target tissue substitute. The methods of the invention comprise the following steps: (a) providing a scaffold comprising one or more layers of one or more arrays of microfibers, wherein one or more of the arrays of microfibers is designed to mimic the configuration of one or more structural elements in a target tissue; and (b) culturing cells on the scaffold to form a target tissue substitute. In another aspect, the invention provides implantable medical devices. The implantable medical devices of the invention comprise a scaffold comprising one or more layers of one or more arrays of microfibers, wherein one or more of the arrays of microfibers is arranged to mimic the configuration of one or more structural elements in a target tissue. Typically, cells are cultured on the scaffold to form a target tissue substitute.

Abstract: In one aspect, the invention provides methods for forming a target tissue substitute. The methods of the invention comprise the following steps: (a) providing a scaffold comprising one or more layers of one or more arrays of microfibers, wherein one or more of the arrays of microfibers is designed to mimic the configuration of one or more structural elements in a target tissue; and (b) culturing cells on the scaffold to form a target tissue substitute. In another aspect, the invention provides implantable medical devices. The implantable medical devices of the invention comprise a scaffold comprising one or more layers of one or more arrays of microfibers, wherein one or more of the arrays of microfibers is arranged to mimic the configuration of one or more structural elements in a target tissue. Typically, cells are cultured on the scaffold to form a target tissue substitute.

Abstract: One aspect of the present invention provides implantable medical devices that comprise: (a) a device body; and (b) a surface layer attached to at least a portion of the device body, the surface layer comprising: (1) a surface layer body that defines an internal surface attached to the device body, and an external surface; and (2) a multiplicity of blood vessels disposed within the surface layer body, the blood vessels opening onto the external face of the surface layer body. The present invention also provides synthetic biocompatible materials, methods for making synthetic biocompatible materials, and methods for making implantable medical devices.