Fenwal, Inc.

Other

Benjamin E Kusters

Kyungyoon Min

Christopher J Wegener

Richard I Brown

Daniel R Boggs

William Henry Cork, Iii

Daniel R Lynn

Mark Joseph Brierton

James Madsen

Katherine N Radwanski

Bryan Blickhan

Mark J Brierton

Marc N Weasler

Prakash Parayll Mathew

Ryan Murphey

Jeannette Wu

Matthew Fang

Daryl R Calhoun

William H Cork

Christopher J Wagener

A fluid separation system and method includes a durable hardware component including a pump station with plurality of pumps, a centrifuge mounting station and drive unit, a plurality of valves and clamps, and a controller. The system includes a single use fluid flow circuit having a separation chamber configured to be received by the centrifuge and the fluid flow circuit is engageable with the durable hardware component to control fluid flow within the fluid flow circuit. The fluid flow circuit having an air access component configured to selectively receive air and to provide the air into a conduit to induce plug flow between the separated fluid component and another separated fluid component, wherein the controller is configured to operate the system to perform one or more blood processing procedures to convey a fluid into the separation chamber and to remove a separated fluid component from the separation chamber.

Systems and methods for inducing plug flow during fluid separation using air

Systems and methods are provided for separating blood into two or more components for collection of red blood cells, plasma, or both red blood cells and plasma. A blood separation system includes a blood separation device and a fluid flow circuit configured to be mounted to the blood separation device. The blood separation device includes a centrifugal separator and a spinning membrane separator drive unit, with the blood being separated into its constituents by the centrifugal separator. Separated plasma may be collected following separation by the centrifugal separator or may first be conveyed from the centrifugal separator into the spinning membrane separator drive unit to separate cellular blood components from the plasma prior to collection of the filtered plasma. The cellular blood components filtered from the plasma may be retained in the circuit as a waste product or may be flushed out of the circuit to a recipient.

Centrifugal separation and collection of red blood cells and plasma

An optical sensor device configured for use in combination with a fluid flowing through a tubing, the optical sensor device includes a light source configured to emit a light, with at least a portion of the light being exposed to a fluid in the tubing and reflected, an optical sensor configured to receive at least a portion of the reflected light and analyze at least a portion of the received reflected light to determine a reflectance measurement, and a controller configured to correlate the reflectance measurement to an input particulate level and generate an output indicative of the fluid flow rate corresponding to the reflectance measurement. Also disclosed is a method of optically measuring fluid flow rate in a fluid processing system including optically monitoring fluid flow through a transparent portion of a tubing by measuring light reflectance of particles in the fluid.

Optical device and method for measuring flow rate

Fluid separation chambers are provided with a central hub, with generally annular low- and high-G walls extending about the hub to define therebetween a separation channel. A plurality of radial walls extend from the hub to the channel to define an inlet passage and two outlet passages. The low-G wall may include an air drain taper and/or a decreased radius adjacent to an associated outlet passage. The radius of the low-G wall and (optionally) the high-G wall may gradually decrease from an upstream end of the channel to a downstream end for improved separation. A ramp may extend across the channel, with a bottom end positioned adjacent to the bottom end of the channel, where the outlet passages open into the channel. The outlet passage associated with the high-G wall may open into the channel at an upstream end of the ramp or at the upstream end of the channel.

Continuous flow centrifugation chambers

A fluid processing device includes a detection assembly having a light source, an adjustment system, and a light detector. The light source is associated with a component of the fluid processing device, provided in an initial position with respect to said component of the fluid processing device, and configured to emit a light. The adjustment system is associated with the light source and configured to adjust the position of the light source. The light detector is configured to receive at least a portion of the light from the light source and generate a signal indicative of the amount of light received by the light detector. The fluid processing device further includes a controller configured to receive the signal from the light detector and control the adjustment system to move the light source to a monitoring position based at least in part on the signal.

Automated adjustment of the position of the light source of a detection assembly for increased light reception

An optical detection assembly for monitoring a biological fluid in a vessel includes two fluid-adjustment structures, which are spaced apart and configured to receive at least a portion of a biological fluid-containing vessel therebetween. A light source (which may be associated with one of the fluid-adjustment structures) is configured to emit light through a thickness of the biological fluid in the vessel, while a light detector (which may be associated with the other one of the fluid-adjustment structures) is configured to receive at least a portion of the light from the light source after it has passed through the biological fluid in the vessel. At least a portion of at least one of the fluid-adjustment structures is configured to move with respect to at least a portion of the other one so as to change the thickness of the biological fluid in the monitored portion of the vessel.

Adjustment of the thickness of a biological fluid being monitored by an optical detection assembly

A prismatic reflector is provided for incorporation into a centrifugal separation chamber. The prismatic reflector is formed of a light-transmissive material and includes inner and outer walls and first and second end walls. The inner wall is configured to receive light traveling along an initial path and transmit the light to the first end wall, with the first end wall receiving the light transmitted through the inner wall and directing the light toward the second end wall in a direction that is angled with respect to the initial path. The second end wall receives the light from the first end wall and transmits the light out of the prismatic reflector. The initial path of the light may be in a direction toward a rotational axis of the centrifugal separation chamber, with the prismatic reflector redirecting the light into a direction substantially parallel to the rotational axis.

Prismatic reflector for centrifugal separation chamber

Blood from a blood source is drawn into a fluid flow circuit. A mononuclear cell product is separated from the blood, followed by at least a portion of the mononuclear cell product being conveyed into an electroporation device without disconnecting the blood source from the fluid flow circuit. The electroporation device opens pores in a membrane of at least one of the cells of the mononuclear cell product to allow DNA material (which is added to the mononuclear cell product prior to electroporation) to enter and modify the genome of the cell. At least a portion of the modified mononuclear cell product is returned to the blood source. The mononuclear cell product may be washed prior to being conveyed into the electroporation device. The modified mononuclear cell product may be washed after exiting the electroporation device.

Collection, genome editing, and washing of T-cell lymphocytes

A fluid processing device includes a controller, a centrifuge configured to receive and rotate a continuous-flow centrifuge chamber, a pump system, an optical detection assembly, and a pressure sensor. The controller executes a priming procedure in which a priming fluid is conveyed into the centrifuge chamber while the chamber is being rotated by the centrifuge, which moves air out of the chamber via a low-g outlet conduit. Upon detecting priming fluid exiting the centrifuge chamber via the low-g outlet conduit, the chamber is rotated at a higher rate to attempt to move any remaining air out of the chamber via the low-g outlet conduit. The controller then determines, based on signals from the optical detection assembly and pressure sensor, whether there is any air remaining in the centrifuge chamber. If so, the rotational rate is alternately decreased and increased until all the air has been cleared from the centrifuge chamber.

Systems and methods for priming a continuous-flow centrifuge chamber

Systems and methods are provided for therapeutic red blood cell exchange and/or therapeutic plasma exchange. A blood separation device includes a centrifugal separator, a spinning membrane separator drive unit, a pump system, and a controller. Blood is conveyed through a fluid flow circuit into either the centrifugal separator or the spinning membrane separator, which separates out the target blood component (red blood cells, in the case of therapeutic red blood cell exchange, or plasma, in the case of therapeutic plasma exchange). The target blood component is retained in the circuit as a waste product, while a replacement fluid is added to the remaining blood component(s), which is then conveyed to a recipient. In addition to allowing for execution of an exchange procedure using either a centrifugal separator or a spinning membrane separator drive unit, the blood separation device also allows for the use of differently sized spinning membrane separators.

Systems enabling alternative approaches to therapeutic red blood cell exchange and/or therapeutic plasma exchange

An umbilicus-driven centrifuge includes a yoke configured to orbit a midsection of the umbilicus around a rotational axis at a first speed so as to cause a separation chamber associated with the umbilicus to rotate about the rotational axis at a second speed that is approximately double the first speed. An optical monitoring system directly monitors the separation chamber, with a light source oriented to emit light toward the separation chamber and a light detector oriented to receive at least a portion of the light after the light has passed through the separation chamber. A controller receives a plurality of signals from the light detector, then compares the period or frequency of the signals to an expected period or frequency. The controller determines that the umbilicus is experiencing an irregularity when the period or frequency is different from the expected period or frequency.

Predicting malfunction and failure of centrifuge umbilicus

Centrifugal separation and collection of red blood cells, plasma, or both red blood cells and plasma

A fluid separation device includes a centrifuge in which a fluid is separated into at least two components, with an interface therebetween. At least a portion of one of the separated fluid components is removed from the centrifuge and flows through a vessel. Light is reflected off of the separated fluid component in the vessel and received and analyzed to determine its main wavelength. If the main wavelength is higher than a maximum value, a target location of the interface is changed. If the main wavelength is less than the maximum value, then the location of the interface is compared to the target location. When the interface is sufficiently close to the target location, the optical density of the separated fluid component in the vessel is compared to a minimum value. If the optical density is less than the minimum value, the target location of the interface is changed.

Adjustment of target interface location between separated fluid components in a centrifuge

The present disclosure relates to systems and methods for the separation of blood into blood products and, more particularly, to systems and methods that permit automated recovery of white blood cells after producing a leukocyte-reduced blood product.

Systems and methods for automated recovery of white blood cells after producing a leuko-reduced blood product

Blood in a separation chamber is separated into a red blood cell layer, a plasma constituent, and a mononuclear cell-containing layer. A portion of the plasma constituent exits the chamber via a plasma outlet, while a first portion of the red blood cell layer exits via a red blood cell outlet. A second portion of the red blood cell layer exits the chamber via the red blood cell outlet and is collected. At least a portion of the collected red blood cell layer may then be conveyed to the chamber via the red blood cell outlet to convey at least a portion of the mononuclear cell-containing layer out of the chamber via the plasma outlet for collection. A second portion of the plasma constituent may be conveyed out of the chamber via the plasma outlet to more fully collect the mononuclear cell-containing layer without the use of collected plasma.

Growing community of inventors

Pleasant Prairie, WI, United States of America

Benjamin E Kusters