Abstract: The invention includes a three-dimensional printing (3DP) machine that has at least one ultraviolet (UV) light source directed at powder or slurry being processed by the 3DP machine and/or directed at any of various surfaces or machine components, in a manner suitable to kill or damage microorganisms to a desired extent. The UV light sources may be either stationary or movable, and may be either pulsed or substantially continuous, and may operate in any desired sequence and timing with respect to other operations performed by the machine. The invention may include ultraviolet illumination in such a way as to interact with powder to sterilize or disinfect powder either while the powder is stationary or, alternatively, as powder is being moved from one place to another within the 3DP machine, or both. The invention also includes methods of performing three-dimensional printing using such illumination.

Abstract: The present invention includes controlled release dosage forms and methods of designing and manufacturing dosage forms to obtain specific release profiles, for example, zero-order release profiles, escalating release profiles or decreasing release profiles. The dosage forms of the present invention can include spatial variation of API concentration in the dosage form and can include nested regions. Dosage forms according to the present invention may be manufactured by any appropriate method for obtaining the internal structure as disclosed herein for producing zero-order release profiles and increasing or decreasing release profiles. The invention further includes methods of manufacturing such dosage forms, such as by three-dimensional printing, possibly also including compression of the dosage form after three-dimensional printing. The invention further includes methods of designing such dosage forms.

Abstract: The invention includes a heat transfer geometry having first and second flow channels in parallel with each other. The flow cross-sectional area of individual channels varies along the length of the flowpath, with one channel undergoing an expansion and the other undergoing a contraction. Different amounts of additional heat transfer surface are located within different regions. In at least some instances, contraction and expansion may occur as a result of a shift of both the left and right boundaries which principally define the channel, and may occur symmetrically with respect to a centerline of the individual channel. With a cell being a first channel and associated second channel, the overall exiting flow may be offset slightly from the overall entering flow. An array may be formed containing multiple cells, and cells at edges of the array may be atypical so that the overall array fits within a simple geometric envelope.

Abstract: The present invention includes controlled release dosage forms and methods of designing and manufacturing dosage forms to obtain specific release profiles, for example, zero-order release profiles, escalating release profiles or decreasing release profiles. The dosage forms of the present invention can include spatial variation of API concentration in the dosage form and can include nested regions. Dosage forms according to the present invention may be manufactured by any appropriate method for obtaining the internal structure as disclosed herein for producing zero-order release profiles and increasing or decreasing release profiles. The invention further includes methods of manufacturing such dosage forms, such as by three-dimensional printing, possibly also including compression of the dosage form after three-dimensional printing. The invention further includes methods of designing such dosage forms.

Abstract: The invention includes biostructures which may be characterized as having substantially all of the organic-solvent-soluble material in the form of a network of irregularly shaped perforated films. The biostructure may further include particles of a substantially-insoluble material, which may be a member of the calcium phosphate family. The biostructure may be osteoconductive. The biostructure may further contain an Active Pharmaceutical Ingredient or other bioactive substance. The API may be a substance which stimulates the production of bone morphogenetic protein, such as Lovastatin or related substances, thereby making the biostructure effectively osteoinductive. One or more of the polymers may have a resorption rate in the human body such as to control the release of the API. Methods of manufacture are also disclosed.

Abstract: Apparatus, systems and methods for use in three-dimensional printing are shown and described. Various embodiments of the invention allow for more precise and controlled delivery of heat to achieve interlayer drying; isolation of the working region from the outside for reasons of cleanliness and in connection with the vapors of organic solvents; better control of the temperature of the working region; better accuracy in the flowrates of binder fluid dispensed; matching of delivered flowrates for multiple dispensers; verification of delivered flowrate or drops; provision for easier changeover of the machine from one powder to another; cleanability; and other needs.

Abstract: The invention is directed to a bone putty composition comprising a carrier formulation comprising water and a carrier substance, and granules wherein said bone putty composition exhibits gel-like Theological properties throughout the temperature range between about body temperature and temperatures approaching about 0° C. The bone putty composition further exhibits reverse phase Theological behavior in at least a portion of the same temperature range. The granules may comprise tricalcium phosphate (hereinafter “TCP”) or other calcium phosphates, they may be porous, and they are suspended in the carrier formulation. In one embodiment of the invention, the bone putty composition withstands exposure to certain temperatures below about room temperature without precipitation of the granules from suspension.

Abstract: The present invention is directed to a biostructure comprising an osteoconductive member and an osteoinductive material. The osteoinductive material may be located within a cavity in the osteoconductive material. In one aspect of the invention the osteoinductive material is demineralized bone matrix and the osteoconductive member comprises tricalcium phosphate.

Abstract: A device for controlling or altering the temperature of a liquid at the point of dispensing. A temperature-altering device is thermally coupled to a dispensing device to compensate for heat dissipated into the liquid as it passes through the dispensing device during dispensing. The dispensing device may be for example, a miniature solenoid valve (microvalve), a piezoelectric printhead, or the like. According to aspects of the invention, a temperature-altering device provides or reduces heat at the point of dispensing in order to alter, control or maintain a constant temperature of the dispensed liquid. As a result, improvement is obtained in the consistency of the fluid regime of the dispensed droplet stream. The temperature-altering device may be a thermoelectric device capable of moving heat either from or to the dispensing structure, or may be a heater.

Abstract: A spinal cage insert for a spinal cage is provided. The spinal cage insert has a shape suitable to be inserted into and fit closely in an interior of the spinal cage. The insert may comprise a member of the calcium phosphate family. The spinal cage insert may be made to a desired shape of porous ceramic, and it may include channels and/or surface features. Various shapes of filler pieces are also provided, wherein the filler pieces may be suitable to augment external regions of vertebrae which have been fused to each other so as to promote build-up of bone. The spinal cage insert and/or the filler pieces may be osteoconductive and may also contain osteoinductive substances or material. The articles may also contain cavities suitable for containing particles of demineralized bone matrix (DBM). Methods of use and methods of manufacturing the spinal cage insert and filler pieces are also provided.

Abstract: A method of cleaning surfaces using a mixed phase cleaning mixture of an aqueous solution and a flow of gas sufficient to produce droplets of the liquid which are entrained by the gas for a time sufficient to clean tubing of various lengths and geometries and porous membranes to remove biofilm, debris and contaminants.

Abstract: The invention is directed to shaped bone void filler pieces having defined porosity. In embodiments of the invention, the shaped bone void filler pieces are presented substantially as wedges, wafers, and axisymmetric bone void filler pieces. The bone void filler pieces further comprise surface and internal features such as recesses, channels, and/or voids. The bone void filler pieces optionally comprise demineralized bone matrix. The invention further is directed to methods of making and methods of using the bone void filler pieces. In another embodiment of the invention, the bone void filler pieces are produced using three dimensional printing methods. In yet another embodiment of the invention, the bone void filler pieces are manufactured with selected porogens integrated therein, which optionally are decomposed following production through a heat-mediated decomposition process, resulting in voids in the bone void filler spaces previously occupied by the porogen(s).

Abstract: The invention includes a three-dimensional printing (3DP) machine that has at least one ultraviolet (UV) light source directed at powder or slurry being processed by the 3DP machine and/or directed at any of various surfaces or machine components, in a manner suitable to kill or damage microorganisms to a desired extent. The UV light sources may be either stationary or movable, and may be either pulsed or substantially continuous, and may operate in any desired sequence and timing with respect to other operations performed by the machine. The invention may include ultraviolet illumination in such a way as to interact with powder to sterilize or disinfect powder either while the powder is stationary or, alternatively, as powder is being moved from one place to another within the 3DP machine, or both. The invention also includes methods of performing three-dimensional printing using such illumination.

Abstract: A method of cleaning surfaces using a mixed phase cleaning mixture of an aqueous solution and a flow of gas sufficient to produce droplets of the liquid which are entrained by the gas for a time sufficient to clean tubing of various lengths and geometries and porous membranes to remove biofilm, debris and contaminants.

Abstract: A bone graft that is made at least partially of synthetic material or demineralized bone matrix and is of a suitable shape to fill a lower portion of a patient's maxillary sinus. The graft may be manufactured to patient-unique dimensions that may be determined radiographically prior to surgery and prior to manufacturing of the bone graft. Other aspects of the invention are a method of manufacture of the bone graft, and methods of installing the bone graft. The installation may make use of patient-unique templates to guide certain cutting operations. Another aspect of the invention is a kit comprising the bone graft, tools for its installation, templates and possibly other surgical items.

Abstract: A bone graft that is made at least partially of synthetic material and is of a suitable shape to fill a recess around the base of an ailing/failing endosseous implant. The bone graft may be pre-manufactured in the suitable shape. The invention also comprises a method of installing either such a bone graft or any other type of filler. The invention also comprises various types of bone graft profiler tools suitable for preparing the recess, and optionally an alignment post to assist in the use of the bone graft profiler tool(s). The dimensions of the bone graft profiler tool(s) and the dimensions of the bone graft and the dimensions of the alignment post may be chosen to have defined geometric relationships with respect to each other, with respect to the dimensions of the existing implant base, and with respect to the extent of bone deterioration at a particular implant site in a particular patient.

Abstract: A composition having an electrical conductivity sufficient to enable droplets to be easily charged when printing through a continuous jet with deflection printhead. The composition may include a halogenated hydrocarbon solvent, a co-solvent that is miscible with the halogenated hydrocarbon solvent, and a conductivity enhancing substance. The halogenated hydrocarbon solvent may be chloroform, and the co-solvent may be an alcohol, such as methanol or ethanol. The conductivity enhancing substance may be a salt that dissociates upon dissolution to form ions, or may be an acid or a polymer. The conductivity enhancing substance may be chosen to be benign if left in a printed product. The conductivity enhancing substance may be chosen to be volatile so as to be able to evaporate from whatever it is printed upon, and specifically may be chosen to be a liquid at room temperature.

Abstract: The rapid design and manufacture of biomedical devices such as implants, oral dosage pills and implantable pharmaceuticals employs electronic data and modeling transmissions via a computer network. Patient information and patient-specific radiological data is captured and transmitted via a computer network to a design and/or manufacturing site. A multi-dimensional digital model is created based on the radiological data and patient information. Communications interchanges between a clinical/diagnostic site and a design/manufacturing site permit modification of the digital model until approved. The approved digital model is converted into machine instructions to construct the biomedical device. Alternatively, the digital model is employed in a best fit selection of a biomedical device from a pre-existing set of biomedical devices or machine-instructions. Transmittal of data over computer networks is further directed to the use of a Website to perform various client-interaction and follow-up tasks.

Abstract: Various elements and alloys selected to achieve both biocompatibility and low melting point for use in infiltrating a porous matrix. The infiltrated porous matrix may be made of ceramic, metal, bioglass, or other suitable material. The infiltrated matrix may be used as a biomedical implant, such as for bone repair and regeneration. The matrix may be manufactured using solid free form fabrication techniques such as three-dimensional printing.

Abstract: The rapid design and manufacture of biomedical devices such as implants, oral dosage pills and implantable pharmaceuticals employs electronic data and modeling transmissions via a computer network. Patient information and patient-specific radiological data is captured and transmitted via a computer network to a design and/or manufacturing site. A multi-dimensional digital model is created based on the radiological data and patient information. Communications interchanges between a clinical/diagnostic site and a design/manufacturing site permit modification of the digital model until approved. The approved digital model is converted into machine instructions to construct the biomedical device. Alternatively, the digital model is employed in a best fit selection of a biomedical device from a pre-existing set of biomedical devices or machine-instructions. Transmittal of data over computer networks is further directed to the use of a Website to perform various client-interaction and follow-up tasks.