Abstract: A spacing device is provided for adjusting or measuring the spacing between adjacent vertebral bodies. The spacing device has a distal end with at least one distraction member adapted for insertion into an intervertebral disc space and movable between a low profile first configuration and a higher profile second configuration. Also provided is an actuator for moving the distraction member between the first configuration (for delivery of the distal end of the spacing device to a target disc space) and the second configuration (for manipulation or measurement of the space between adjacent vertebral bodies).

Abstract: A method for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid by using a device comprising at least one analyte quantification member and a sensor associated therewith, the method includes: applying a first sample to the analyte quantification member; and detecting the presence or absence of an adequate sample volume; wherein upon detection of the absence of an adequate sample volume, initiating a finite timed period, and signaling the user to introduce a second sample of body fluid to the analyte quantification member. Associated arrangements and devices are also disclosed.

Abstract: Disclosed are devices, arrangements and methods for quantifying the concentration of an analyte present in bodily fluid, including: an assay pad having at least one chemical reagent capable of producing a detectable signal in the form of a reaction spot upon reaction with the analyte; a light source; a detector array; a processor; and a memory in communication with the processor, the memory comprising: (a) at least one value indicative of one or more of: (i) the level of hematocrit contained in the sample; (ii) the volume of the sample applied to the assay pad; or (iii) imperfections present in the reaction spot; and (b) at least one algorithm for calculating the concentration of the analyte contained in the sample.

Abstract: Methods and apparatus are disclosed for distracting tissue. The devices and methods may include insertion of first and second elongated members into the space between two tissue layers, with an augmenting elongated member inserted therebetween to form a distraction device between the tissues to be distracted. The distraction device defines a generally annular configuration, with a locking member secured to one of the elongated members at a plurality of locations to maintain the distraction device in the generally annular configuration. The augmenting elongated member may be shorter than the first and second elongated members such that a window is defined between the proximal and distal ends of the augmenting elongated member when the distraction device and the first and second elongated members are in the generally annular configuration. Bone graft material or bone filler may be introduced into the interior of the distraction device through the window.

Abstract: An arrangement includes a housing, a plurality of sampling and analysis sites contained within the housing, each of the sampling and analysis sites having a skin-penetration member having a first end configured to pierce the skin, and an inner lumen in communication with the first end, an actuator operatively associated with the skin-penetration member, and an analyte quantification member in fluid communication with the inner lumen of the skin-penetration member. Integrated devices including such arrangements are also described.

Abstract: Methods and apparatus are disclosed for distracting tissue. The devices and methods may include insertion of first and second elongated members into the space between two tissue layers, with an augmenting elongated member inserted therebetween to form a distraction device between the tissues to be distracted. The distraction device defines a generally annular configuration, with a locking member secured to one of the elongated members at a plurality of locations to maintain the distraction device in the generally annular configuration. The augmenting elongated member may be shorter than the first and second elongated members such that a window is defined between the proximal and distal ends of the augmenting elongated member when the distraction device and the first and second elongated members are in the generally annular configuration. Bone graft material or bone filler may be introduced into the interior of the distraction device through the window.

Abstract: Devices and methods are provided for measuring and/or adjusting the distance between two opposing surfaces of a work space, such as two vertebral bodies separated by a disc space. A sizing device may include at least one distraction member, an actuator, and an actuator controller. The actuator controller is movable to move the actuator, with movement of the actuator changing the height dimension of the distraction member. The amount of movement of the actuator controller is generally linearly related to the change of the height dimension of the distraction member. The amount of expansion force applied by the distraction member is also generally linearly related to the amount of movement of the actuator controller.

Abstract: A graft material injector device and method are disclosed. The injector device includes an elongated injector tube and a side loading aperture for receiving graft material. A graft material loader and a cover for the side loading aperture may optionally be included.

Abstract: An arrangement includes a housing, a plurality of sampling and analysis sites contained within the housing, each of the sampling and analysis sites having a skin-penetration member having a first end configured to pierce the skin, and an inner lumen in communication with the first end, an actuator operatively associated with the skin-penetration member, and an analyte quantification member in fluid communication with the inner lumen of the skin-penetration member. Integrated devices including such arrangements are also described.

Abstract: Disclosed are devices, arrangements and methods for quantifying the concentration of an analyte present in bodily fluid, including: an assay pad having at least one chemical reagent capable of producing a detectable signal in the form of a reaction spot upon reaction with the analyte; a light source; a detector array; a processor; and a memory in communication with the processor, the memory comprising: (a) at least one value indicative of one or more of: (i) the level of hematocrit contained in the sample; (ii) the volume of the sample applied to the assay pad; or (iii) imperfections present in the reaction spot; and (b) at least one algorithm for calculating the concentration of the analyte contained in the sample.

Abstract: Devices and methods are provided for measuring and/or adjusting the distance between two opposing surfaces of a work space, such as two vertebral bodies separated by a disc space. A sizing device may include at least one distraction member, an actuator, and an actuator controller. The actuator controller is movable to move the actuator, with movement of the actuator changing the height dimension of the distraction member. The amount of movement of the actuator controller is generally linearly related to the change of the height dimension of the distraction member. The amount of expansion force applied by the distraction member is also generally linearly related to the amount of movement of the actuator controller.

Abstract: The present disclosure relates to devices and methods for creating channels within bone. One method for treating bone generally includes traversing an elongated member through cancellous bone of a vertebral body along a first generally non-linear path and then retracting the elongated member, thereby leaving a generally non-linear channel. The elongated member then is traversed through the cancellous bone along a second generally non-linear path, which second path does not completely coincide with the first path and then retracted along the second generally nonlinear path, thereby leaving a second generally non-linear channel. Optionally, bone filler material is deployed into the channels.

Abstract: An arrangement for producing a sample of body fluid from an opening created in a skin surface at a sampling site including a cartridge with a plurality of compartments and a plurality of sampling sites, and a detector assembly. Each sampling site includes a skin-penetration member having a first end configured to pierce the surface of the skin and an inner lumen in communication with the first end, a spring actuator operatively associated with the skin-penetration member, and a needle hub connecting the skin-penetration member and the spring actuator. The needle hub includes a reagent pad and the spring actuator is configured to drive the skin-penetration member to form the wound opening. Each compartment at least partially encloses the skin-penetration member, the spring actuator, and the needle hub of a respective sampling site.

Abstract: An apparatus for disrupting tissue in the intervertebral disc space that includes a barrier member having a first configuration for insertion into the disc space and a second configuration when deployed within the disc space. The second configuration of the barrier member is adapted to at least partially define a perimeter of a working region within the disc space. The apparatus also includes a tissue disruption tool configured for insertion into the working region.

Abstract: Discectomy or disc preparation system that includes a guide member that is changeable from a deployment configuration for insertion into an intervertebral disc space to a deployed configuration upon being deployed into the intervertebral disc. The system also includes at least one tissue manipulator, such as cutting, scraping and extraction elements, that can be moved or tracked longitudinally along the guide member into and through the intervertebral disc space.

Abstract: Disclosed are devices, arrangements and methods for quantifying the concentration of an analyte present in bodily fluid, including: an assay pad having at least one chemical reagent capable of producing a detectable signal in the form of a reaction spot upon reaction with the analyte; a light source; a detector array; a processor; and a memory in communication with the processor, the memory comprising: (a) at least one value indicative of one or more of: (i) the level of hematocrit contained in the sample; (ii) the volume of the sample applied to the assay pad; or (iii) imperfections present in the reaction spot; and (b) at least one algorithm for calculating the concentration of the analyte contained in the sample.

Abstract: An arrangement for producing a sample of body fluid from an opening created in a skin surface at a sampling site including a cartridge with a plurality of compartments and a plurality of sampling sites, and a detector assembly. Each sampling site includes a skin-penetration member having a first end configured to pierce the surface of the skin and an inner lumen in communication with the first end, a spring actuator operatively associated with the skin-penetration member, and a needle hub connecting the skin-penetration member and the spring actuator. The needle hub includes a reagent pad and the spring actuator is configured to drive the skin-penetration member to form the wound opening. Each compartment at least partially encloses the skin-penetration member, the spring actuator, and the needle hub of a respective sampling site.

Abstract: Disclosed are devices, arrangements and methods for quantifying the concentration of an analyte present in bodily fluid, including: an assay pad having at least one chemical reagent capable of producing a detectable signal in the form of a reaction spot upon reaction with the analyte; a light source; a detector array; a processor; and a memory in communication with the processor, the memory comprising: (a) at least one value indicative of one or more of: (i) the level of hematocrit contained in the sample; (ii) the volume of the sample applied to the assay pad; or (iii) imperfections present in the reaction spot; and (b) at least one algorithm for calculating the concentration of the analyte contained in the sample.

Abstract: The present disclosure relates to devices and methods for creating channels within bone. One method for treating bone generally includes traversing an elongated member through cancellous bone of a vertebral body along a first generally non-linear path and then retracting the elongated member, thereby leaving a generally non-linear channel. The elongated member then is traversed through the cancellous bone along a second generally non-linear path, which second path does not completely coincide with the first path and then retracted along the second generally nonlinear path, thereby leaving a second generally non-linear channel. Optionally, bone filler material is deployed into the channels.

Abstract: An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes at least one skin-penetration member having a first end configured to pierce the surface of the skin, and a inner lumen in communication with the first end; at least one actuator operatively associated with the at least one skin-penetration member; and at least one catalyst device configured to cause perfusion of body fluid at the sampling site; wherein the at least one actuator is configured to locate the at least one skin-penetration member so as to obstruct the wound opening while transporting body fluid through the inner lumen. Associated methods are also described.