Abstract: A method for separating and collecting cell-free plasma by finger stick that minimizes contamination with genomic DNA from a donor. The method comprising placing a tourniquet on one of the digits of the donor's finger to apply pressure, lancing the digit to create an incision in the digit, and collecting blood from the incision from the incision site. The collected blood is placed on a separation membrane wherein the separation membrane is in contact with a collection membrane and both the separation and collection membrane are inserted into a substrate configured to provide overlap between the membranes. A kit and instructions for carrying out the method is also provided.

Abstract: The present approach relates to the design and use of a functionally closed bioreactor designed to immobilize, culture, and mature tissue on a loading platform. The bioreactor may be equipped with sensors for tissue monitoring which in conjunction with stiffness data can provide closed-loop control of tissue maturation. Based on a relationship between cartilage stiffness and tissue maturity, measurements of stiffness can be acquired and used as a surrogate for cartilage maturity without the need for destructive tests.

Abstract: A disposable cell enrichment kit includes a crossflow filtration device configured to be disposed along a main loop pathway and to receive a process volume containing a biological sample and utilize crossflow filtration, via a micro-porous membrane, to retain a specific cell population in a retentate from the process volume and to remove a permeate including certain biological components from the process volume. The crossflow filtration device includes a laminated filtration unit that includes the micro-porous membrane, a first mating portion, a second mating portion, and a membrane support. The membrane support includes a first plurality of structural features that define a first plurality of openings, wherein the first plurality of structural features are coupled to the micro-porous membrane and provide support to the micro-porous membrane, and the first plurality of openings allow the permeate to flow through them after crossing the micro-porous membrane.

Abstract: An assistive sample collection and storage assembly for collecting, transferring and storing a biological sample includes a sample collection device having a first portion and a second portion. The first portion is configured to receive a sample collection member. The assembly includes a sample storage device comprising a sample substrate to receive at least a portion of the biological sample from the sample collection member. The assembly is configured to exist in a first and second state. The sample collection member is disposed at a determined distance from the sample substrate in the first state. At least a portion of the sample collection member is in physical contact with at least a portion of the sample substrate in the second state. The sample collection member is configured to apply a determined amount of contact force between the collection member and the sample substrate in the second state of the assembly.

Abstract: A semi-automated sampling assembly configured for aseptic sampling at one or more instances from a sample source having a biological inoculum is provided. The semi-automated sampling assembly includes a sampling conduit, a recovery conduit, one or more sampling kits, and a pumping device. The sampling conduit includes a first port and a second port, where the first port of the sampling conduit is configured to be operatively coupled to the sample source. Further, the recovery conduit includes a first port and a second port, where the first port of the recovery conduit is configured to be operatively coupled to the sample source. Also, the second port of the recovery conduit is operatively coupled to at least a portion of the sampling conduit. Moreover, the one or more sampling kits are operatively coupled to the sampling conduit, and the pumping device is operatively coupled to the sampling conduit.

Abstract: Disclosed herein is a cell harvesting instrument suitable for concentrating cells from a source suspension of cells and/or washing said cells, the instrument comprising: a housing for accommodating mechanical elements including at least one fluid pump, at least one valve; and a processing kit removably insertable into the housing, said kit including a generally flat frame having or supporting plural sealed fluid paths arranged in a generally flat plane and such that fluids in the paths do not contact said mechanical elements, wherein at least portions of the fluid paths comprise flexible tubes, the outer surfaces of which are manipulateable by the or each fluid pump, to provide fluid flow in one or more of the paths and/or by the or each valve to restrict fluid flow in one or more of the paths. In an embodiment, the kit comprises also a fluid processing reservoir and a filter suitable for separating cells from fluid in said paths.

Abstract: Disclosed herein is an instrument suitable for processing cells for example culturing, concentrating or washing said cells, the instrument comprising: a housing for accommodating mechanical elements including at least one fluid pump; and a disposable processing kit complementary to the mechanical elements within the housing and comprising a fluid circuit including a fluid reservoir and plural fluid paths capable of carrying fluid flow caused by said pump(s), the instrument further including a mechanism for determining the quantity, or change in quantity of the fluid in the reservoir resulting from said fluid flow, the instrument yet further comprising a controller operable to control at least the pump and operable to perform a fault determination process, which includes the steps of determining the expected flow rate of said pump(s) calculated from the speed of the pump(s) and comparing that expected flow with the change in quantity of the fluid in the reservoir as determined by said mechanism.

Abstract: An assistive sample collection and storage assembly for collecting, transferring and storing a biological sample includes a sample collection device having a first portion and a second portion. The first portion is configured to receive a sample collection member. The assembly includes a sample storage device comprising a sample substrate configured to receive at least a portion of the biological sample from the sample collection member. The assembly is configured to exist in a first state and a second state. The sample collection member is disposed at a determined distance from the sample substrate in the first state. At least a portion of the sample collection member is in physical contact with at least a portion of the sample substrate in the second state. The sample collection member is configured to apply a determined amount of contact force between the collection member and the sample substrate in the second state of the assembly.

Abstract: A bioreactor is provided. The bioreactor is a multi-scalable bioreactor, which comprises a culture vessel for seeding and culturing cells by adding a cell-culture media, wherein the culture vessel comprises at least a side wall and a bottom surface, a specific heat transfer area and a specific gas transfer area; wherein the culture vessel is configured to accommodate the cell-culture media volume up to 10 liters, and wherein the specific heat transfer area and the specific gas transfer area are independent of cell-culture media volume. A kit for culturing cells in a large scale is also provided which further comprises disposable tubings, culture bag or combinations thereof. A method for culturing cells is also provided.

Abstract: An assistive sample collection and storage assembly for collecting, transferring and storing a biological sample includes a sample collection device having a first portion and a second portion. The first portion is configured to receive a sample collection member. The assembly includes a sample storage device comprising a sample substrate configured to receive at least a portion of the biological sample from the sample collection member. The assembly is configured to exist in a first state and a second state. The sample collection member is disposed at a determined distance from the sample substrate in the first state. At least a portion of the sample collection member is in physical contact with at least a portion of the sample substrate in the second state. The sample collection member is configured to apply a determined amount of contact force between the collection member and the sample substrate in the second state of the assembly.

Abstract: A high-throughput system for processing biological material that comprises: a tray that supports a functionally-closed fluid path subsystem comprising, a vessel for containing and enabling the biological material to separate into two or more distinct submaterials; one or more receptacles to receive one or more of the submaterials from the vessel; a filtration device; a conduit through which one or more submaterials are transported between at least the vessel and the filtration device; and a first engagement structure; a processing unit comprising, a pumping device for moving one or more of the submaterials between at least the vessel and the filtration device via the conduit; a second engagement structure corresponding to the first engagement structure; a locking mechanism for at least temporarily holding the tray in a fixed position relative to the processing unit; a control device that automatically starts and stops the pumping device in response to one or more commands.

Abstract: A substrate for positioning a separation membrane and a collection membrane for separating and collecting plasma is disclosed. The substrate includes an inner flexure disposed proximate to a first peripheral portion of the substrate and an outer flexure disposed surrounding at least a portion of the inner flexure. The inner flexure is formed from a plurality of first slots in the substrate and the outer flexure is formed from a plurality of second slots in the substrate.

Abstract: An ultrasound scan probe and support mechanism are provided for use in a multi-modality mammography imaging system, such as a combined tomosynthesis and ultrasound imaging system. In one embodiment, the ultrasound components may be positioned and configured so as not to interfere with the tomosynthesis imaging operation, such as to remain out of the X-ray beam path. Further, the ultrasound probe and associated components may be configured to as to move and scan the breast tissue under compression, such as under the compression provided by one or more paddles used in the tomosynthesis imaging operation.

Abstract: The present approach relates to the design and use of a functionally closed bioreactor designed to immobilize, culture, and mature tissue on a loading platform. The bioreactor may be equipped with sensors for tissue monitoring which in conjunction with stiffness data can provide closed-loop control of tissue maturation. Based on a relationship between cartilage stiffness and tissue maturity, measurements of stiffness can be acquired and used as a surrogate for cartilage maturity without the need for destructive tests.

Abstract: The present invention is directed to a squeegee apparatus which includes a main housing including an inlet end and an outlet end, the outlet end including an extrusion face and a protruding lip member, the inlet end including an inlet opening and the extrusion face including at least one outlet opening, wherein the inlet opening and the at least one outlet opening are in fluid communication with each other within the main housing. The present invention is also directed to a method for repairing a thermal barrier coating with a squeegee apparatus including supplying a repair composition into the inlet opening of the squeegee apparatus and depositing the repair composition from the at least one outlet opening onto the damaged region and concurrently traversing the squeegee apparatus over the damaged region while contacting a thermal barrier coating adjacent to the damaged region with the lip member.

Abstract: The present disclosure relates to the manufacture and use of a non-rigid breast compression paddle, such as a compression paddle having a mesh material forming the primary interface with patient tissue. In certain implementations, an automatic feedback driven approach may be used in conjunction with such a compression paddle for compressing breast tissue.

Abstract: A heating assembly for a bioreactor is disclosed. The heating assembly includes a holder having a plurality of segments coupled to each other to define a unitary structure and a heating component coupled to at least one segment of the plurality of segments. The unitary structure includes a top end, a bottom end, and a side wall. The side wall extends between the top end and the bottom end and along a circumferential direction of the heating assembly to define a cavity. At least a portion of the unitary structure has a gradually varied perimeter along a direction perpendicular to a plane which intersects the side wall and is parallel to the top end and the bottom end.

Abstract: A sampling assembly configured to be coupled to a sample source and facilitate aseptic sampling at one or more instances in time is provided. Further, the sampling assembly includes a first conduit having first and second ports, where the first port is configured to be coupled to the sample source. The sampling assembly also includes a plurality of sub-conduits having corresponding sub-ports, where each of the plurality of sub-conduits is operatively coupled to the first conduit at respective connector junctions. Also, each of the sub-ports is in fluidic communication with the first conduit. The sampling assembly also includes a plurality of sampling kits and one or more pumping devices. Further, each sampling kit is operatively coupled to a respective sub-port of a corresponding sub-conduit. Moreover, the one or more pumping devices are operatively and aseptically coupled to the second port of the first conduit.

Abstract: An imaging catheter assembly is presented. The imaging catheter assembly includes an imaging catheter which includes an imaging catheter tip. Further, the imaging catheter assembly includes a fluid reservoir connected to the imaging catheter and configured to deliver fluid through a proximal end of the imaging catheter tip. The imaging catheter assembly also includes a release mechanism configured to cause delivery of the fluid to the imaging catheter tip when activated.

Abstract: A bioreactor is provided. The bioreactor is a multi-scalable bioreactor, which comprises a culture vessel for seeding and culturing cells by adding a cell-culture media, wherein the culture vessel comprises at least a side wall and a bottom surface, a specific heat transfer area and a specific gas transfer area; wherein the culture vessel is configured to accommodate the cell-culture media volume upto 10 liters, and wherein the specific heat transfer area and the specific gas transfer area are independent of cell-culture media volume. A kit for culturing cells in a large scale is also provided which further comprises disposable tubings, culture bag or combinations thereof. A method for culturing cells is also provided.