Abstract: Macrocyclic gadolinium-based contrast agents (GCA) are synthesized by pathways characterized by the formation of a sequence of metastable complexes before obtaining the final stable complex. Commercial macrocyclic GCAs contain unstable metastable complexes. These metastable species quickly release free Gd3+ ions upon delivery into the body. Aqueous or dry/solid GCA with near zero metastable species content and methods of synthesizing the same are disclosed.

Abstract: Disclosed herein are complexes of gadolinium metal, ligand and meglumine that are substantially free of non-aqueous solvents. In particular, solvent-free complexes of 1) gadopentetate dimeglumine and 2) gadoterate meglumine are disclosed and methods of their preparation are disclosed. In addition, methods are disclosed for purifying reactants, monitoring and controlling pH, quantifying the free gadolinium content, quantifying the concentration of gadolinium-ligand complex in aqueous solution, and procedures for producing a drug product in one step. The one step process eliminates the need to dry the gadolinium-ligand complex, which is typically highly hygroscopic. The one step process includes purification steps that do not require the use of non-aqueous solvents.

Abstract: A bone adhesive application device has a pliable structure with an application surface upon which a bone adhesive may be applied. The application surface has a surface energy substantially equal to or less than a surface energy of the bone adhesive to reduce adhesion between the bone adhesive and the bone adhesive application device. The bone adhesive application device may be included in a kit for repairing bone defects having a bone adhesive formed from a reactive biocompatible polyurethane material. The bone adhesive may be applied to a bone defect by positioning the pliable structure over at least a portion of the bone defect, delivering the bone adhesive to the bone defect and removing the pliable structure from the bone adhesive.

Abstract: A method for closing a sternum separated into at least a first sternum portion and a second sternum portion includes preparing at least one cut surface of at least one of the first or second sternum portions to have an adhesive applied thereon. The adhesive is applied to at least a portion of the at least one cut surface. The at least one cut surface is approximated to a second cut surface of the other of the first sternum portion or second sternum portion. As the adhesive cures, it bonds with the first cut surface and the second cut surface. Preparing the at least one cut surface may remove contaminants that could inhibit adhesion of the adhesive. The adhesive may be applied through adhesive injection holes formed along an incision separating the first and second sternum portions. Devices for preparing the cut surfaces and applying the adhesive are also provided.

Abstract: A method for sternal closure of a separated sternum includes applying an adhesive to a portion of an incision between at least a first sternum portion and at least a second sternum portion and maintaining the first sternum portion proximate to the second sternum portion until the adhesive has bonded with the first sternum portion and the second sternum portion. The adhesive may be applied over substantially the entire length of the incision or may be applied in intervals. The method for sternal closure may also include compressing the first sternum portion and the second sternum portion together using one or more compression devices and introducing adhesive to contact regions where the compressive devices contact the sternum. The method may also include cutting an interface feature in the first and second sternum portions or spanning the incision between the first and second interface portions with a structural support.

Abstract: A bone defect filler for implantation in a bone defect of a patient includes a particulate polymer distributed within a polymeric binder. The particulate polymer includes a plurality of particles, which may have substantially the same material composition as the polymeric binder. The particles of the particulate polymer may be formed in a variety of shapes and/or sizes to provide the bone defect filler with improved pore interconnectivity, material expansion and contamination characteristics, while maintaining sufficient mechanical strength and handling characteristics for bone repair applications. The bone defect filler also provides the flexibility to be molded or shaped in situ to fill the bone defect.

Abstract: A bone repair apparatus includes a partially polymerized biocompatible adhesive provided in a state wherein polymerization of the biocompatible adhesive is substantially suspended. A method for repairing a bone defect includes preparing the biocompatible adhesive, suspending polymerization of the biocompatible adhesive prior to full cure, delivering the biocompatible adhesive to the bone defect while polymerization is substantially suspended and accelerating polymerization of the biocompatible adhesive to achieve full cure. The method provides an implanted biocompatible adhesive with a malleable osteoconductive structure without compromising the physical characteristics of the biocompatible adhesive, thereby improving handling and delivery of the bone adhesive.

Abstract: A bone adhesive application device has a pliable structure with an application surface upon which a bone adhesive may be applied. The application surface has a surface energy substantially equal to or less than a surface energy of the bone adhesive to reduce adhesion between the bone adhesive and the bone adhesive application device. The bone adhesive application device may be included in a kit for repairing bone defects having a bone adhesive formed from a reactive biocompatible polyurethane material. The bone adhesive may be applied to a bone defect by positioning the pliable structure over at least a portion of the bone defect, delivering the bone adhesive to the bone defect and removing the pliable structure from the bone adhesive.

Abstract: A bone defect filler for implantation in a bone defect of a patient includes a particulate polymer distributed within a polymeric binder. The particulate polymer includes a plurality of particles, which may have substantially the same material composition as the polymeric binder. The particles of the particulate polymer may be formed in a variety of shapes and/or sizes to provide the bone defect filler with improved pore interconnectivity, material expansion and contamination characteristics, while maintaining sufficient mechanical strength and handling characteristics for bone repair applications. The bone defect filler also provides the flexibility to be molded or shaped in situ to fill the bone defect.

Abstract: A bone defect filler for implantation in a bone defect of a patient includes a particulate polymer distributed within a polymeric binder. The particulate polymer includes a plurality of particles, which may have substantially the same material composition as the polymeric binder. The particles of the particulate polymer may be formed in a variety of shapes and/or sizes to provide the bone defect filler with improved pore interconnectivity, material expansion and contamination characteristics, while maintaining sufficient mechanical strength and handling characteristics for bone repair applications. The bone defect filler also provides the flexibility to be molded or shaped in situ to fill the bone defect.

Abstract: A method for sternal closure of a separated sternum includes applying an adhesive to a portion of an incision between at least a first sternum portion and at least a second sternum portion and maintaining the first sternum portion proximate to the second sternum portion until the adhesive has bonded with the first sternum portion and the second sternum portion. The adhesive may be applied over substantially the entire length of the incision or may be applied in intervals. The method for sternal closure may also include compressing the first sternum portion and the second sternum portion together using one or more compression devices and introducing adhesive to contact regions where the compressive devices contact the sternum. The method may also include cutting an interface feature in the first and second sternum portions or spanning the incision between the first and second interface portions with a structural support.

Abstract: A method for closing a sternum separated into at least a first sternum portion and a second sternum portion includes preparing at least one cut surface of at least one of the first or second sternum portions to have an adhesive applied thereon. The adhesive is applied to at least a portion of the at least one cut surface. The at least one cut surface is approximated to a second cut surface of the other of the first sternum portion or second sternum portion. As the adhesive cures, it bonds with the first cut surface and the second cut surface. Preparing the at least one cut surface may remove contaminants that could inhibit adhesion of the adhesive. The adhesive may be applied through adhesive injection holes formed along an incision separating the first and second sternum portions. Devices for preparing the cut surfaces and applying the adhesive are also provided.

Abstract: A multi-density polymeric interbody spacer formed from biocompatible material for osteoconductivity includes multiple density regions of different porosity to provide both strength and osteoconductivity. An interface region is formed between the density regions to provide both direct adhesion and mechanical interlocking between the different density regions to increase the strength of the multi-density polymeric interbody spacer. A method for forming the multi-density polymeric interbody spacer includes curing a first density region to achieve a first target porosity. A second density region may then be molded to the first density region to achieve a second target porosity. A portion of the second density region partially flows into pores of the first density region, providing direct adhesion and mechanical interlocking between the first and second density regions.

Abstract: A multi-density polymeric interbody spacer formed from biocompatible material for osteoconductivity includes multiple density regions of different porosity to provide both strength and osteoconductivity. An interface region is formed between the density regions to provide both direct adhesion and mechanical interlocking between the different density regions to increase the strength of the multi-density polymeric interbody spacer. A method for forming the multi-density polymeric interbody spacer includes curing a first density region to achieve a first target porosity. A second density region may then be molded to the first density region to achieve a second target porosity. A portion of the second density region partially flows into pores of the first density region, providing direct adhesion and mechanical interlocking between the first and second density regions.

Abstract: Systems and techniques for fusing bone or bone fragments. In one aspect, an apparatus includes an interbody member holder comprising a connector and a channel arranged to form a flow connection between the interbody member holder and an interior channel of an interbody member held on the connector.

Abstract: An inflatable speculum adapted to be positioned within an orifice includes an inflatable bladder. In an embodiment, when the inflatable bladder is inflated, the inflatable bladder includes a baffle member. The baffle member includes a plurality of baffles, and each of the plurality of baffles has a substantially trapezoidal cross-sectional shape. The inflatable bladder also includes an opening formed between a first end of the inflatable bladder and a second end of the inflatable bladder for viewing an inside of the orifice. In another embodiment, when the inflatable bladder is inflated, the inflatable bladder includes the opening formed between the first end of the inflatable bladder and the second end of the inflatable bladder, a pump and inflation line for inflating the inflatable bladder, and an applicator.

Abstract: A stethoscope is described. The stethoscope includes a head assembly, an ear piece assembly, and a tubing assembly. The tubing assembly has a first end connected to the head assembly and a second end connected to the ear piece assembly. The tubing assembly includes a first acoustic chamber and three insulation chambers. The insulation chambers include a first material having a first density and are disposed around the first acoustic chamber. The tubing assembly also includes an outer layer, which includes a second material having a second density. Moreover, the outer layer is disposed around the insulation chambers. In another embodiment, the outer layer is substantially frictionless and the tubing assembly is flexible. In yet another embodiment, the stethoscope further includes a second acoustic chamber and the insulation chambers are disposed around a portion of the first acoustic chamber and a portion of the second acoustic chamber.

Abstract: In an exemplary embodiment of the present invention, a method of performing a medical procedure includes the step of applying a particular material to a portion of a bone of a mammal. The particular material includes at least one glyceride and stimulates bone growth. For example, cyclic adenosine monophosphate regulated lipases may metabolize the particular material after the particular material is applied to the bone. The at least one glyceride of the particular material and water within the mammal then may be converted into glycerol, fatty acid, and protons, which stimulates a conversion of osteoprogenitor cells into osteoblast cells. Subsequently, the glycerol and the fatty acid may be oxidized, and the oxidation may stimulate the conversion of adenosine diphosphate within the mammal into adenosine triphosphate. The osteoblast cells then may convert the adenosine triphosphate into adenosine diphosphate, such that energy is released.

Abstract: According to this invention an orthopedic screw having a first portion and a second portion is disclosed, wherein said first portion comprises a head having a substantially smooth exterior surface and further comprising a recessed portion, wherein said recessed portion comprises a polygonal shape and a deflection beam, such that said first portion receives a driver head within said recessed potion, and wherein said second portion comprises an elongated portion adapted for insertion into a substrate.

Abstract: An unrolling inflatable speculum comprising an insertion device, wherein said insertion device comprises a mandrel having a shaft portion and a head portion, a baffled bladder, wherein said baffled bladder comprises an open cell structure and an at least one such that access is permitted through the surface of said bladder through said opening, and an inflation mechanism, wherein said inflation mechanism is comprised of a handheld bulb-pump and an inflation line.