University of Washington

Joan E Sanders

Katheryn J Allyn

Timothy Myers

Brian Hafner

John Cagle

Ellen L Lee

Brian Otis

Kirk Watson Beach

Stuart B Mitchell

Michael R Severance

Daniel S Harrison

Daniel C Abrahamson

Santosh Zachariah

Joseph L Garbini

Thomas Neumann

George M Turkiyyah

Jake McLean

Jacob Brzostowski

Horace Wang

Samuel Bennett

Christian B Redd

Andrew Vamos

Ethan Weathersby

Elizabeth A Sorenson

Aaron B Baker

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.

Motorized adjustable socket for amputee prosthesis users and methods for use thereof

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.

System to evaluate prosthetic sockets

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.

Apparatus for controlled electrospinning

Parameters related to use of a prosthesis by a patient with a limb amputation are monitored using a tool that includes one or more piezoelectric force sensors. The resulting data are processed for use both in short and long term management of amputee patients. The sensor is a small modular unit that fits within or between traditional prosthetic components, e.g., below a prosthesis socket. The data produced by the tool are collected, processed, and stored. Optionally, the data are periodically communicated to a remote site via a network, e.g., over the Internet. The device and associated software used to process the data can be used to characterize activities conducted by a prosthesis user, to determine pistoning or threatening interface stress distributions between the limb and socket, mal-alignment of the socket, use of improper components, and other possibly undesired conditions that the amputee patient using the prosthesis may be experiencing.

Prosthetic limb monitoring system

A prosthetic sock monitoring system is disclosed. The sock monitoring system includes a storage device and a data collection unit. The data collection unit is operable to receive data from at least one sensor coupled to a prosthetic sock that is wearable by a patient, and store the received data in the storage device. A prosthetic sock is also disclosed. The sock comprises material shaped to fit over at least a portion of the residual limb of the patient and a thickness adapted for inserting the residual limb into the socket of the prosthesis while the sock is fitted over the residual limb. The sock also comprises one or more of a sock identification unit and a force sensing device.

Limb volume accommodation in people with limb amputation

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.

Measurement and use of in-socket residual limb volume change data for prosthetic fitting

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.

Computer aided design and manufacturing of transtibial prosthetic sockets

Method for controlled electrospinning

In one aspect the present invention provides medical devicesthat each include a plurality of fibers, substantially all of the plurality of fiberseach including a portion having a maximum diameter of at least five micrometers, wherein substantially all of fibersform a layer on at least one external surface of medical device. In another aspect, the present invention provides methods of manufacturing medical devices, the methods including the steps of: (a) applying a layer comprising a plurality of fibersto at least one surface of medical device; and (b) matching the value of the Young's modulus of the layer to +/&#x2212;35% (in some embodiments to +/&#x2212;20%) of the value of the Young's modulus of an animal tissue.

Medical devices comprising small fiber biomaterials, and methods of use

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.

Bioengineered tissue substitutes

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.

Structures and methods for promoting vascularization

In one aspect the present invention provides indented structures that each include (a) a body defining a plurality of indentations, substantially all of the plurality of indentations including a surface layer including a biologically active substance; and (b) a body surface, wherein each of the plurality of indentations opens onto the body surface through a plurality of openings, and wherein the biologically active substance is not substantially present on the body surface. Examples of structures of the present invention include medical devices, such as medical devices that are completely or partially implantable into a living body. The surface layer of the indentations (or at least some of the indentations) of the medical devices of the invention may include biologically active molecules, such as proteins, that promote the growth of cells into and/or within the indentations, thereby promoting the acceptance of the implanted device by the living body. In another aspect, the present invention provides methods for making indented structures.

Growing community of inventors

Sammamish, WA, United States of America

Joan E Sanders