This invention generally relates to centrifugal systems used to separate and/or isolate substances based on their density, size, viscosity, or shape for use in a variety of applications. More specifically, the invention relates to portable centrifugal systems used to separate blood into its blood components, including platelet poor plasma (PPP), platelet rich plasma (PRP) and red blood cells (RBC), as well as other different types of tissues, such as stem cells and its stem cell derivatives.
Currently systems used to separate blood to produce or separate into specific blood components, such as platelet poor plasma (PPP), platelet rich plasma (PRP) and red blood cells (RBC) commonly involve a centrifuge. Traditional blood separation centrifuges are based on three basic rotor designs: 1) the swinging bucket centrifuge; 2) the fixed angle centrifuge; and 3) the vertical tube centrifuge, where blood is injected into test tubes and spun within a chamber to induce a stacked or “cake-tier” separations.
Problems exist with current commercially available or traditional centrifuges. First, the conventional centrifuges are difficult to sterilize with the electrical components, in particular circuitry and power components and prevent them from being used in-situ in sterile environments requiring pre-processing or post-processing of a patient's blood. Secondly, cell damage may occur due to excessive steps with handling of the blood. Thirdly, extraction of blood components after centrifugation becomes exceedingly difficult and requires skilled personnel. The centrifugation process positions the blood components within the test tube in a stacked or layered configuration and requires specialized tools to properly extract the blood components without cross-contamination. Finally, the separation of the blood components usually results in at least 3 specific stacked layers of PPP, PRP, and RBCs, and if optimization of the concentrations of these blood components are desired, it requires multiple centrifugation cycles and excessive time to acquire the ideal concentration of each blood component.
Thus, a need exists for a blood separation system and process that (1) can be used in a sterile and/or non-sterile environment; (2) minimizes the number of handling and processing steps; (3) greatly simplifies the extraction of the blood components; and (4) allows automatic separation of different concentrations of PRP, tissue and/or stem cells with a single centrifugation cycle and/or reduced centrifuge cycles.
The present disclosure is directed towards instruments, systems, and related methods for apheresis. The instruments, systems, and related methods may facilitate blood separation, bone marrow separation, or tissue separation while minimizing handling and exposure to non-sterile environments. The instrument, systems, and related methods include a portable centrifuge system with a self-contained power source.
In one aspect, a centrifuge is provided, having a base container having a rotational mechanism contained within. Included is a centrifuge container having a bottom plate and a top plate joined by a circumferential sidewall, and with a coiled spring connected to the bottom plate. The centrifuge further includes a sequester wheel having a plurality of concentric rings, forming at least one channel, connected to a hub. The sequester wheel is engaged with the bottom plate, the coiled spring positioned therebetween, with the hub centered with the bottom plate and the top plate within the centrifuge container, defining an axis. The sequester wheel engagement may comprise a permanent fixation (not removable) or temporary fixation (removably connected or engaged). The centrifuge container is engaged with the rotational mechanism and rotatable about the axis.
In another aspect, a centrifuge is provided having, a base container having a rotational mechanism contained within. The centrifuge may further comprise a sequester device having a first center, a circumferential outer ring concentric with a plurality of inner tiered concentric rings forming at least one channel, and a container. The sequester device is engaged with the base container defining an axis. The sequester device engagement may comprise a permanent fixation (not removable) or temporary fixation (removably connected or engaged). The centrifuge further includes a centrifuge cover having a top side with a second center and a circumferential sidewall. The centrifuge cover is connected to the sequester device and forming a cylindrical container having an internal space with an outer channel, with the cylindrical container coupled to the rotational mechanism and rotatable about an axis defined by the first center and the second center. Furthermore, the base container further comprises at least one light, an activation switch, and/or any combination thereof.
In yet another aspect, a centrifuge is provided having a base container having a rotational mechanism contained within. Also included is at lease on cap having a cylindrically shaped container having a top side with a first center, a bottom side with a second center, a sidewall, and an interior having an anti-coagulant and a thixotropic separation gel within, where the cylindrical container is coupled to the rotational mechanism and is rotatable about an axis defined by the first center and the second center.
In still another aspect, a centrifuge is provided having a base container having a rotational mechanism connected to an activation switch. Included is a cap assembly having a cap at a first end of an articulated arm, an activation tab at a second end, and an activation handle protruding from the articulated arm. The centrifuge further includes an activation armature, a conical first member positioned within a conical second member having a plurality of openings and positioned within a conical third member, and a base ring. The first member engages the base ring and the base container, the activation armature extends from the base ring to the activation switch within the base container. The second member engages the rotation mechanism above the first member and the third member is positioned above the second member to engage the first member, the second member being rotatable between the first member and the second member. The cap engages the third member, and the activation tab engages the activation armature, providing a connection between the activation handle and the activation switch for activation of the rotational mechanism.
In another embodiment, the portable centrifuge comprising a base, a sequester device, a container cover, at least one light, and a protective cover. The base comprising a rotational mechanism; the sequester device being disposed onto the base, the sequester device including a plurality of concentric rings that are spaced apart to form at least one channel and a central container; the container cover including at least one injection tube and at least one extraction region, the at least one extraction region including a plurality of extraction holes, the container cover being disposed over a portion of the sequester device; and a protective cover, the protective being disposed over the container cover. The at least one light may comprise a UV light. The UV light includes a wavelength emission within the UV-C wavelength range. At least a portion of the sequester device, at least a portion of the plurality of concentric rings, and/or at least a portion of the central container comprising a coating. The coating is selected from a group consisting of anticoagulants, preservatives, germicidal agents, sterilants, antiseptics, clot activators, separator gels. The germicidal agents comprise amotosalen or riboflavin. The UV-C wavelength range comprises a range of 200 to 280 nanometers.
In another embodiment, the portable centrifuge comprising a base, a sequester device, a container cover and a protective cover. The base comprising a rotational mechanism, a first light and a second light; the sequester device being disposed onto the base, the sequester device including a plurality of concentric rings that are spaced apart to form at least one channel and a central container; the container cover including at least one injection tube and at least one extraction region, the at least one extraction region including a plurality of extraction holes, the container cover being disposed over a portion of the sequester device; and a protective cover, the protective being disposed over the container cover. The first light or the second light may comprise a UV-A light. The UV light includes a wavelength emission with the UV-A wavelength range. At least a portion of the sequester device, at least a portion of the plurality of concentric rings, and/or at least a portion of the central container comprising a coating. The coating comprises a germicidal agent, the germicidal agent comprises amotosalen or riboflavin. The UV-A wavelength range comprises a range of 315 to 400 nanometers.
In another embodiment, a microfluidic portable centrifuge comprising a base, a sequester device, a container cover, a protective cover, and at least one coagulation module; the base comprising a rotational mechanism, the sequester device being disposed onto the base, the sequester device including a plurality of concentric rings that are spaced apart to form at least one channel and a central container. The container cover including at least one injection tube, at least one extraction region, the at least one extraction region including a plurality of extraction holes. The at least one coagulation module disposed onto the container cover, the at least one coagulation module comprising a top surface, a bottom surface, and a microfluidic mechanism, the microfluidic mechanism disposed between the top surface and the bottom surface, the bottom surface including a blood communication port, the container cover being disposed over a portion of the sequester device; and a protective cover, the protective being disposed over the container cover. The microfluidic mechanism comprises at least one serpentine microchannel or the microfluidic mechanism comprises a plurality of serpentine microchannels. The microfluidic mechanism comprises at least one serpentine microchannel and a metering mechanism. The microfluidic portable centrifuge further comprises a first light and a second light, the first light or second light comprises a UV light, the UV light comprises a wavelength emission within the UV-C wavelength range for a germicidal effect. The at least one serpentine microchannel comprises a coating.
In yet another aspect, a method is provided including removing a protective cover from a centrifuge, introducing blood into a centrifuge container, replacing the protective cover of the centrifuge, turning the protective cover to activate the centrifuge, separating the blood into constituent components by rotation of the centrifuge, removing the protective cover from the centrifuge, and removing the blood constituent components.
In another embodiment, a microfluidic coagulation centrifuge comprising: a centrifuge, the centrifuge comprises a longitudinal axis, the centrifuge adapted to receive a fluid; and at least one coagulation module, the at least one coagulation module disposed onto the centrifuge, the coagulation module comprising a fluid chamber, an inlet and an outlet, the inlet and outlet are in fluid communication with the fluid chamber, fluid being in fluid communication with the inlet of the coagulation module to allow the fluid to flow through the fluid chamber towards the outlet at a set time to measure a coagulation potential. The fluid chamber comprises a serpentine shape. The inlet is adjacent to the longitudinal axis and the outlet is away from the longitudinal axis. The at least one coagulation module comprises clotting indicators. The centrifuge is rotatable about the longitudinal axis to create a pressure differential. The flow of the fluid is directed by the pressure differential. The flow of the fluid that is directed by the pressure differential flows toward the longitudinal axis. The fluid is blood. The fluid chamber is planar. The at least coagulation module comprises a translucent material.
In another embodiment, the microfluidic coagulation centrifuge comprising: a centrifuge, the centrifuge comprising a longitudinal axis, the centrifuge is adapted to receive a fluid, centrifuge is rotatable about the central axis forcing the fluid to be movable from a first radial distance with a first centrifugal force to a second radial distance with a second centrifugal force to create a pressure differential therebetween and a first fluid flow direction; at least one coagulation module, the at least one coagulation module disposed onto the centrifuge, the coagulation module comprising a fluid chamber, an inlet and an outlet, the inlet and outlet are in fluid communication with the fluid chamber, the movable fluid being directed to the inlet through the fluid chamber towards the outlet in a second flow direction by the pressure differential of the centrifuge to measure a coagulation potential at a set time. The fluid chamber comprises a serpentine shape. The second centrifugal force is higher than the first centrifugal force. The inlet is adjacent to or within the second radial distance. The inlet and the outlet comprise an axially alignment. The at least one coagulation module comprises clotting indicators. The second fluid flow direction is towards the longitudinal axis of the centrifuge. The first fluid flow direction is opposite to the second fluid flow direction. The fluid chamber is planar. The at least coagulation module comprises a translucent material. The centrifuge further comprises a sequester wheel, the sequester wheel comprises a first ring that defines the inner container, and a second ring, the second ring is concentric with the first ring, the second ring is spaced apart from the first ring to create a channel.
In another embodiment, the portable centrifuge comprises: a base, the base comprises a rotational mechanism and a longitudinal axis; a sequester wheel, the sequester wheel disposed onto the base, the sequester wheel comprising a first ring, a second ring, a third ring, a first channel and a second channel, each of the first, second and third rings are concentric to each other, the first channel is disposed between a first ring and a second ring, the second channel is disposed between a second ring and a third ring, the first ring forms the inner container; a heating mechanism; one or more disaggregation elements; and a cover, the cover comprising an injection port, and at least one extraction region, the at least extraction region including one or more extraction openings, the one or more extraction openings are aligned with each of the first and second channels, the cover disposed over the sequester wheel. The heating mechanism comprises an electrical heater or a chemical heater. The heating mechanism is disposed onto the base or the sequester wheel. The first ring or second ring comprises a filtration ring, the filtration ring includes a filtration mesh size of at least 40 micrometers or greater. The one or more disaggregation elements disposed onto the third ring, the one or more disaggregation elements includes a plurality of facets that disaggregates different medium types. The cover further comprises at least one blister module, the at least one blister module comprises a chamber, a frangible base and a reagent, the chamber is movable from a first position that is uncompressed with the chamber filled with the at least one reagent to a second position that is compressed breaking the frangible base to dispense the at least one reagent into the sequester wheel. The at least one blister modules are removably connected to the cover. The portable centrifuge further comprises a filtration mechanism, the filtration mechanism coupled to the injection port of the cover, the filtration mechanism includes a filtration mesh size of at least 40 micrometer or greater. The inner container of the sequester wheel comprises a reagent, the reagent includes a separation gel. The first or second channel comprises a reagent, the reagent includes a separation gel.
In a further aspect, a method is provided including removing a protective cover, introducing blood into a centrifuge container, replacing the protective cover, turning the protective cover to activate the centrifuge, having the blood interact with a thixotropic separation gel and an anti-coagulant, separating the blood into constituent components by activation of the centrifuge, removing the protective cover, and removing the blood constituent components.
In another aspect, a method is provided including removing a protective cover from a centrifuge, introducing blood into a centrifuge container, replacing the protective cover on the centrifuge, turning the protective cover to activate the centrifuge, separating the blood into constituent components, removing the protective cover, and removing the blood constituent components.
In a yet another aspect, a method is provided including removing a cap assembly, introducing blood into test-tubes, replacing the cap assembly, pressing the activation handle to activate the centrifuge, separating the blood into constituent components by activation of the centrifuge, removing the cap assembly, and removing blood constituent components from the test-tubes.
These, and other objects, features and advantages of this invention will become apparent from the following detailed description of the various aspects of the invention taken in conjunction with the accompanying drawings.
The present invention will be understood more fully from the detailed description given hereinafter and from the accompanying drawings of certain embodiment of the present invention, which, however, should not be taken to limit the invention, but are for explanation and understanding only.
There is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary, or the following detailed description. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the inventive concepts defined in the appended claims. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting, unless the claims expressly state otherwise.
The following description references systems, methods, and apparatuses for a cordless centrifugal device, or one with an internal power source, for separating blood (e.g. venous blood) into mesenchymal stem cells (MSCs), blood plasma, platelet rich plasma (PRP), platelet poor plasma (PPP), and/or red blood cells (RBC). Other aspects of the invention include systems, method, and apparatuses for a centrifugal device with an internal power source for separating bone marrow into bone marrow aspirate concentrate (BMAC), separating stem cells and/or mononuclear cells, stromal vascular fraction and other components, hemopoetic cells from tissue (e.g. adipose ‘fat’ tissue, periosteum, muscles, synovial membrane, skin, bone or trabecular bone, etc.), bone marrow, and whole blood. Still other aspects of the invention include systems, methods, and apparatuses for a centrifugal device for use with animal blood, bone marrow, and tissue. The following description also references systems, methods, and apparatuses for a centrifugal device with an internal power source for blood, bone marrow, or tissue preparation without having to leave the surgical environment. However, those possessing an ordinary level of skill in the relevant art will appreciate that other fluids, mixtures, slurries, tissue preparations, and liquids are suitable for use with the foregoing systems, methods, and apparatuses. Furthermore, those possessing an ordinary level of skill in the relevant art will appreciate that this device may be used outside the surgical environment, in sterile and non-sterile environments, and in veterinary surgical environments. Likewise, the various figures, steps, procedures, and work-flows are presented only as an example and in no way limit the systems, methods or apparatuses described to perform their respective tasks and/or outcomes in different time-frames or orders. The teachings of the present invention may be applied to medical processes for viruses, cell cultures, proteins, nucleic acids, and polymers, and may be implemented in other processes that have similar separation considerations.
Aspects of the present disclosure and certain embodiment, features, advantages, and details thereof, are explained more fully below with reference to the non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known materials, fabrication tools, processing techniques, etc., are omitted so as not to unnecessarily obscure the relevant details. It should be understood, however, that the detailed description and the specific examples, while indicating aspects of the disclosure, are given by way of illustration only, and are not by way of limitation. Various substitutions, modifications, additions, and/or arrangements, within the spirit and/or scope of the underlying inventive concepts will be apparent to those skilled in the art from this disclosure.
Approximating language, as used herein throughout disclosure, may be applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as “about” or “substantially,” is not limited to the precise value specified. In some instances, the approximating language may correspond to the precision of an instrument for measuring the value.
Terminology used herein is for the purpose of describing particular examples only and is not intended to be limiting. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. Furthermore, references to “one embodiment” are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. Moreover, unless explicitly stated to the contrary, the terms “comprising” (and any form of “comprise,” such as “comprises” and “comprising”), “have” (and any form of “have,” such as “has” and “having”), “include” (and any form of “include,” such as “includes” and “including”), and “contain” (and any form of “contain,” such as “contains” and “containing”) are used as open-ended linking verbs. As a result, any embodiments that “comprises,” “has,” “includes” or “contains” one or more step or element possesses such one or more step or element, but is not limited to possessing only such one or more step or element. As used herein, the terms “may” and “may be” indicate a possibility of an occurrence within a set of circumstances; a possession of a specified property, characteristic or function; and/or qualify another verb by expressing one or more of an ability, capability, or possibility associated with the qualified verb. Accordingly, usage of “may” and “may be” indicates that a modified term is apparently appropriate, capable, or suitable for an indicated capacity, function, or usage, while taking into account that in some circumstances the modified term may sometimes not be appropriate, capable, or suitable. For example, in some circumstances, an event or capacity can be expected, while in other circumstances the event or capacity cannot occur—this distinction is captured by the terms “may” and “may be.”
As used herein, the term “portion” is not limited to a single continuous body of material unless otherwise noted. A “portion” may include multiple sub-portions that may be the same or differing materials, and/or may include coatings, adhesives, and the like, and may be a separate and distinct component or may be an integral section, segment, or fragment of a larger component. As used herein, the term “coupled” is not limited to a direct coupling of two separate and distinct components. Two “coupled portions” may include indirectly coupled portions or directly coupled portions.
The systems, methods, and apparatus described are directed to a cordless and/or portable centrifugal device for use in a sterile and/or a non-sterile environment. The cordless and/or portable centrifugal device overcomes many of the disadvantages of the conventional centrifugal machines. The portable centrifuge (1) can be used in a sterile and/or non-sterile environment; (2) minimizes the number of handling and processing steps; (3) eliminates the need for test tubes and thus eliminates spills or breakage within the portable centrifuge; (4) greatly simplifies the extraction of the blood components; and (5) reduces or eliminates the need to balance the portable centrifuge with a “dummy” test tube(s); (6) allows automatic separation of different concentrations of PRP with a single centrifugation cycle; (7) fewer moving parts and fewer mechanical failures.
The portable centrifuge leverages the centrifugation principles to simplify extraction. The portable centrifuge is a device that is used to separate components of a mixture according to density, shape, viscosity, and/or particle size by depositing the separate components into their respective channels (see
The portable centrifuge can exhibit a wide range of centrifugal forces or G-forces than compared to traditional rotor centrifuges. The portable centrifuge system exhibits a G-force or centrifugal force that comprises substantially zero and/or zero gravitational forces (or G forces) at the axis of rotation 698 and/or proximate to the axis of rotation 698. Accordingly, the G-forces progressively increases linearly in the radial direction from the smallest radius 695 (e.g. potentially smallest ring) towards the largest radius or largest ring on the sequester wheel, radius 1 690, radius 2 692, and/or radius 3 695 within the sequester wheel. The portable centrifuge may comprise G-forces from 0 to 10,000 Gs. This is highly contrasted by the traditional rotor centrifuges, which the traditional rotor centrifuges will never reach substantially zero or zero G-forces at and/or proximate to the axis of rotation 698. Each of the traditional centrifuges have substantially greater G-force due its minimum radius 687 and maximum radius 689 based on its design, which may be 2000 Gs and greater.
The portable centrifuge may desirably reduce or eliminate mechanical failures. The portable centrifuge does not include swinging parts (e.g., swinging bucket), nor does it require balancing prior to centrifugation. This is highly contrasted by conventional or traditional centrifuges. Conventional rotor centrifuges require the mixture or whole blood be placed into test tubes (see
In one exemplary embodiment, the portable centrifuge may minimize the number of handling and processing steps compared to conventional centrifugation techniques. The portable centrifuge provides for reduced handling and transferring of blood because the steps may be performed in a single location, thus reducing potential cross-contamination to extracted blood components and ensuring chain of title or chain of custody of the patient's blood. The portable centrifuge may comprise the steps of withdrawing the blood from a patient; injecting blood into portable centrifuge; activating centrifuge; and extracting blood components from the portable centrifuge; and injecting the extracted blood components into the patient. This contrasts with conventional techniques. Some conventional techniques involve a blood draw in a non-sterile separate location, which the blood is stored in a treated or non-treated test tube. The test tube is sent to a different lab for centrifugation cycle to separate the patient's blood into its separate components and then the specific components must be extracted and stored in second container for use or injection (e.g. syringe). The extracted components are then injected into the patient subcutaneously in a non-sterile environment potentially using visual guidance (e.g. ultrasound or fluoroscopy imaging). This conventional process is a time-consuming process.
In another embodiment, the portable centrifuge may comprise immediate separation of different concentrations of PRP's with a single centrifugation cycle. The PRP can be used “as-is” or it can be further separated into concentration 1 PRP and/or concentration 2 PRP. The PRP may be separated further into leukocyte-rich PRP (LR-PRP), defined as having a neutrophil concentration above baseline, and leukocyte-poor (LP-PRP) preparations, defined as having a leukocyte (neutrophil) concentration below baseline. In one embodiment, the PRP may comprise PRP concentration 1 and PRP concentration 2, the concentration 1 and/or 2 may comprise PRP, LP-PRP, LR-PRP, and/or any combination thereof. Such separation of the different concentrations of the PRP allows physicians to have specific recommendations for each separate concentration (PRP, LR-PRP and/or LP-PRP) for each musculoskeletal indication. Accordingly, the portable centrifuge may comprise a first blood component, a second blood component, and a third blood component. Alternatively, the portable centrifuge may comprise a first blood, component, a second blood component, a third blood component, and a fourth blood component, and/or any combination thereof. The portable centrifuge may comprise a first blood, component, a second blood component, a third blood component, a fourth blood component, a fifth blood component and/or any combination thereof. The blood components may include PPP, PRP, LR PRP, LP-PRP, RBC, and/or any combination thereof.
Applications
In another exemplary embodiment, the portable centrifuge may be used as an in-situ preparation for PPP and/or PRP therapies for musculoskeletal injuries and/or inflammation. Platelet-rich plasma (PRP) is a preparation of autologous human plasma with an increased platelet concentration produced by centrifuging a larger volume of a patient's own blood. Platelets contain a plethora of growth factors and mediators in their alpha granules (TGF-β1, PDGF, bFGF, VEGF, EGF, IGF-1), which are concentrated through the centrifugation process to release supraphysiologic amounts of these growth factors and cytokines to an injury site and augment the natural healing process. Platelet-rich plasma (PRP) therapy requires an injection of a concentration of a patient's own “active” platelets (e.g., the platelets may be activated with the addition of calcium chromide or thrombin) into injured or diseased body tissue to accelerate the healing of injured or inflamed tendons, ligaments, muscles, and joints. Then, the PRP releases the growth factors that stimulate and increase the number of reparative cells that a patient's body produces. PRP therapy can reduce the need for the administration of anti-inflammatories or stronger medications like opioids. In addition, the side effects of PRP injections are very limited because the injections are created from the patient's own blood, and the patient's body will not reject or react negatively to them.
In another embodiment, the portable centrifuge may be used as an in-situ preparation for convalescent plasma therapy that treats a disease condition where the pathogenesis is linked or associated to a specific toxic biologic substance and/or an infectious disease. Convalescent plasma therapy or plasmapheresis is the removal, and the return or exchange of blood components that contain antibodies into the patient for treatment of infectious diseases (e.g. COVID-19) and/or other toxic biologic substances. It can be used as a current or reactive treatment modality and/or used prophylactically to prevent infection. The portable centrifuge may allow for autologous plasma therapy, plasma exchange (PE, PLEX or PEX) or plasma exchange therapy (PET), and/or by donation. The portable centrifuge may further allow for single use, discontinuous flow centrifugation, continuous flow centrifugation, and plasma filtration. Discontinuous flow centrifugation requires a venous catheter line, and removal of 300 ml of blood at a time and centrifuged to separate plasma from blood cells. Continuous flow centrifugation may require two venous lines and requires slightly less blood volume out of the body at any one time, as it is able to continuously spin out plasma. Plasma filtration may require two venous lines and the plasma is filtered using standard hemodialysis equipment. This continuous process requires that less than 100 ml of blood be outside the body at one time. Single-use process comprises an injection of autologous or non-autologous (e.g. donation) blood to be centrifuged, which the centrifuged blood components, namely plasma, will be extracted and administered directly to the patient.
In another embodiment, the portable centrifuge may be used for treatment of various ocular or ophthalmological disorders, including, but not limited to dry eye syndrome, persistent epithelial defects (PEDs), neurotropic ulcerations, limbal deficiency and/or corneal dystrophies. The use of blood derivatives or blood components is highly desirable as a therapeutic approach to stimulate and accelerate tissue healing within the eye. The coagulated or anticoagulated blood may be centrifuged to separate into its constituent blood components, including plasma or serum (30% to 55%) and formed elements (70% to 45%) (e.g., formed elements includes RBCs, platelets and WBCs). Plasma and/or serum may be further filtered using a standard filtration media and administered using a variety of eye dispensing mechanisms. The eye dispensing mechanisms may comprise a pipette, a syringe, an eye dropper, and eye dropper with integral filter, a mechanical dispenser, and/or any dispensing mechanisms known in the art. The serum or plasma eye drops may be used as a reactive treatment modality and/or be used prophylactically. The serum or plasma eye drops may comprise autologous or non-autologous blood components.
In another embodiment, the portable centrifuge may be used for rapid and accurate assessment of blood hemostasis via microfluidic technology in conjunction with centrifugation (e.g., separation of blood into its blood constituent components). Rapid, quantitative and accurate hemostasis monitoring is critical in many clinical settings (for example, surgery, trauma, sepsis, anticoagulation and anti-platelet therapies) to anticipate, avoid and direct the management of serious disorders due to bleeding or thrombosis. An increasing number of patients are diagnosed with COVID-19 require precise and personalized anticoagulation dose monitoring on as close to real-time basis as possible to maintain homeostasis in-vivo to prevent any serious health effects from COVID-19 coagulopathies. Therefore, the lack of managing anticoagulation dosage precisely and continuously is a common cause of catastrophic hemorrhage and mortality in patients. Moreover, the requirement for monitoring homeostasis reliably at the bedside using low blood volumes is even more critical in pediatric patients with acute coagulopathy (acquired or congenital), as they are more vulnerable than adults. As a result, the portable centrifuge may comprise a simple microfluidic device for real-time monitoring of hemostasis and platelet function that permits rapid determination of a clotting time for native whole blood as it is perfused through a network of channels. The network of channels may be configured in such a way to potentially mimic local physiologically relevant changes in hemodynamics flow conditions experienced in living stenosed arterioles.
In another embodiment, the portable centrifuge may be used for isolation of different types of stem cells from embryonic and/or adult tissues for use in stem cell therapies (e.g., regenerative medicine) and research. Stem cells are characterized as cells endowed with continuous self-renewal ability and pluri- or multipotentiality and could consequently give rise to a large panel of cell types. Isolation of a large volume of stem cells with purity and viability must be completed to be useful for treatment purposes, thus leading to the development of stem cell separation technologies. The portable centrifuge may offer isolation of embryonic or adult stem cells via density gradient and/or differential centrifugation techniques without the complexity of steps of standard techniques, thereby minimizing sample variability, meeting the purity and viability standards and delivering more efficient on-site isolation.
Portable Centrifuge
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Each of the plurality of rings having at least one surface, at least one surface comprising a coating. Accordingly, each of the plurality of rings having a first surface and a second surface, the first surface and second surface having a coating. Accordingly, each of the plurality of rings having a first surface, a second surface and a third surface, the first surface, second surface and third surface having a coating. The coating may comprise anticoagulants, preservatives, disinfectants or germicidal agents or pathogen reduction agents or pathogen inactivation agents, sterilants, antiseptics, clot activators, separator gels. The at least one first surface, first surface, second surface or third surface may be surface directly in contact with the patient's whole blood or its separated blood components.
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In other aspects of the centrifuge 100, the number of channels in a sequester wheel 105 may range from a single channel to five channels, with an inner ring and an outer ring having approximately the same dimensions to the first ring 114 and the third ring 116. In other aspects of the centrifuge 100, the centrifuge container 130 may be sized to, for example, hold ml of fluid and internal components (e.g. the spring 109 and the sequester wheel 105), with the internal diameter of the centrifuge container 130 remaining approximately 60 mm to 70 mm, but having a height to accommodate the greater volume. In still other aspects of the centrifuge 100 for holding 60 ml of fluid, the height of the sequester wheel 105 may range from, approximately 21 mm to 25 mm. In other aspects of the centrifuge 100, rotation of the centrifuge container 130 may be slowed by the presence of a brake button on the protective container 103 to frictionally slow the centrifuge container 130. In still other aspects, the solenoid armature 163 may remain extended and contacting the toggle switch 111, aiding with braking the centrifuge container 130.
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In another embodiment, the sequester device 405 comprises a central opening or inner container 420, a fourth ring 419, a third ring 418 and a second ring 417; the fourth ring 419, the third ring 418 and second ring 417 are spaced apart and aligned concentrically to create a first channel 440, and a second channel 441. The second ring 417 having a larger or taller height than the fourth ring 419. Each of the channels 440, 441 having a surface or a bottom surface 658, 660, 662 to hold blood products in a volume. At least a portion of the central opening or inner container 420 comprising a coating. The coating may comprise anticoagulants, preservatives, disinfectants or germicidal agents or pathogen reduction agents or pathogen inactivation agents, sterilants, antiseptics, clot activators, separator gels.
The first ring 416, the second ring 417, the third ring 418 are spaced apart from each other creating a first channel 440, a second channel 441, and a third channel 442. Each of the first channel 440, the second channel 441, and the third channel 442 comprising a bottom surface and/or connecting material 658, 660, 662. The bottom surface and/or connecting material 658, 660, 662 comprises a flat, planar surface or an angled and/or sloped surface. The angled or sloped surface includes an angle within the range of 1 degree to 10 degrees; or 1 degree to 5 degrees. The angle or sloping may be in a direction towards the central axis. The bottom surface or plurality of bottom surfaces 658,660,662 may be positioned at different heights 668,670, 672 from the bottom surface of the sequester wheel or device 405 resulting in a portion of the plurality of concentric rings 416, 417, 418, 419 having the same height as shown in
Alternatively, the plurality of concentric rings 416, 417, 418, 419 each have connecting material 658,660, 662 forming a plurality of channels, with, for example, the third ring 418 and the fourth ring 419 forming a first channel 440, the second ring 417 and the third ring 418 forming a second channel 441, and the first ring 416 and the second ring 417 forming a third channel 442. The first channel 440, second channel 441, and the third channel 442 may, for example, be sized to have a volume of 1 ml to 2 ml, and more specifically a volume of 1.5 ml. The outer surface of the first ring 416 extends away from the top of the first ring towards a bottom where a sequester device base ring or base ring 414, extends approximately perpendicular from the first ring 416 in a concentric formation with the plurality of rings. At an outer circumference, the base ring 414 has a rim or connection edge 415, with the rim 415 having a diameter of, for example, approximately 68 mm. The fourth ring 419 has a top and a bottom, with the bottom area of the fourth ring 419 being enclosed and forming an inner bowl or inner container 420, having for example, a diameter of approximately 36 mm to 38 mm, and more specifically a diameter of 38 mm. The inner container 420 may have, for example, a volume of approximately 20 ml. The inner container 420 may comprise a cylindrical or circular wall 659 and a bottom surface 660. The bottom surface 660 may comprise a flat, planar surface (see
With reference to
The inner container 420 of the at least one concentric ring 419 may be sized and configured to receive an eye dispenser mechanism 712, 716 and/or a filter 714. The eye dispenser mechanism 712 may comprise a pipette 716, a syringe, an eye dropper, and eye dropper with integral filter 720, a mechanical dispenser, and/or any dispensing mechanisms known in the art. For example, the filter 714 may comprise a blood serum filter, piston filter, a reagent filter and/or a pre-filter manufactured by POREX Filtration Group of Fairburn, GA. Alternatively, the filter 714 may comprise a HEMO-NATE blood filtration system manufactured by Utah Medical Products, Inc. of Midvale, UT and/or a standard cylindrical mesh with desired porosity or pore sizes (e.g. screen membranes). Such filters 714 removes small volumes of particulate debris to allow viable blood product to be extracted with ease. Accordingly, the pipette 716 and/or syringe may include a general-purpose transfer pipette or syringe for routine extraction of blood, blood components and/or any other biological fluids. The pipette 716 and/or syringe may hold different capacities or volumes (1 ml to 10 ml).
The at least one of the concentric rings 419 comprising a first end, and a second end. The second end adjacent to a surface or a bottom surface 658, the first end adjacent to the bottom surface 732 of the container cover 704. The first end comprising a tapered end or a drafted end, the tapered end or drafted end being a 0.5% to 3% tapering, and/or a 0.5% to 1.5% tapering. Desirably, the tapering produces a draft angle between 0.5 degrees to 5 degrees to facilitate easy release of molds during manufacturing, and also helps facilitation of the blood product during centrifugation to climb or scale the walls easily and deposit in the plurality of channels and/or cavity.
With continued reference to
With continued reference to
The plurality of rings 416, 417, 418, 419 and/or the at least one concentric ring 419 comprises a shape. The shape includes a circle. The shape can further include regular polygons, such as a triangle, a square, a pentagon, a hexagon, a septagon, an octagon and/or any other combination thereof. Alternatively, other shapes may include symmetrical polygons. The shape of the plurality of rings 416, 417, 418, 419 may be the same or it may be different. The shape of each of the plurality of rings 416, 417, 418, 419 may be the same or it may be different.
With reference to
With reference to
With continued reference to
It is contemplated that the sequester wheel 405 of the centrifuge 400 may have, for example, one channel to five channels.
With reference to
The entire portable centrifuge 600,700,738,744 can be completely sterile, and single use. If the entire portable centrifuge is single use, the entire portable centrifuge is used once and then disposed appropriately. Alternatively, a portion of the entire portable centrifuge 600,700,738,744600,700 can be sterile, and single use. If a portion of the portable centrifuge 600,700,738,744 is single use, a portion of the portable centrifuge 600,700 is used only once then discarded appropriately, and the remaining portion may be re-used again. In one embodiment, a portion of the portable centrifuge 600,700,738,744 comprises the sequester device 405,706 and the container cover 625,704,740,746 being single use, and the protective cover 601,702 and the base re-useable. In another embodiment, a portion of the portable centrifuge 600,700,738,744 comprises the sequester device 405,706, the container cover 625,704, 740,746 and protective cover 601,702 being single use, and the base re-useable.
The base 708,730,742 of the centrifuge 600,700,738,744 comprises a rotational mechanism 650 disposed on a baseplate 101 which is enclosed within base cover 102 as shown in
Referring to
Referring to
The protective cover 601,702 has an activation tab 608 extending from the bottom rim 623 as a freestanding member, configured (e.g. shaped and dimensioned) for insertion into the activation slot 107. The protective cover 601,702 is configured (e.g. shaped and dimensioned) to cover the centrifuge container 610 and/or the sequester wheel 405,706, while providing clearance between an interior surface of the protective cover 626 and the centrifuge container 610 and/or the sequester wheel 405,706, and with the activation tab 608 inserted into the activation slot 107. The protective cover 601,702 further has a brake 607, which is similar to brake 401 and having already been described above, for the sake of brevity, will be described to note additional embodiment elements. The brake 607 may have, for example, a brake pad 612 extending from the bottom surface 626. The brake pad may be, for example, wedge shaped and positioned between the center of the bottom surface 626 and the sidewall 617, thickening in the direction of the sidewall 617. The protective cover 601,702 may, for example, be fabricated from a clear plastic polymer material or a material through which blood separation columns and/or plurality of rings may be visible.
In another embodiment, the protective cover 601,702 may comprise at least one light or a plurality of lights (not shown). The at least one light or the plurality of lights comprises a fluorescent lamp (CFL), an incandescent bulb, a halogen bulb, a light emitting diode (LED) bulb, an ultra-violet (UV) light, and/or any combination thereof. Each of the plurality of lights may be the same or they may be different. The at least one light or the plurality of lights coupled or positioned adjacent to the top surface 615, a bottom surface or bottom side 626, internal circumference sidewall 618 and the circumferential sidewall 617 of the protective cover 601,702.
In other embodiments, a syringe connector may be connected to the tube or port 613, such as, for example, a female Luer Lock adaptor for engagement with a male Luer Lock syringe. With a Luer Lock connector, a seal 619 may, for example, not be required. Also, during centrifugation, the syringe with the male Luer Lock connector may, for example, remain connected to the female Luer Lock connector.
The protective cover 601,702 may further comprise an insertion barrier 619. The insertion barrier is positioned between the opening 609 and the insertion opening 630. In embodiments where the insertion barrier 619 covers the cavity 620, a sealed space may, for example, exist between the protective cover 601,702 and the container cover 625,704 when the protective cover 601,702 is engaged, with the activation tab 608 inserted into the activation slot 107. The insertion tube or port 613 of protective cover 601,702 may be, for example, aligned with the insertion tube or port 629 of the container cover 625,702.
Referring to
The conical shape of the top surface 631,724 may, for example, minimize the impact formation of an air pocket between the top of the sequester device 405,706 and the container cover 625,704. Such an air pocket may, for example, inhibit blood constituents from flowing out from the inner container 420 of the sequester ring 405,706, towards the channels (e.g. the first channel 440, the second channel 441, and the third channel 442). By having a conical top surface 631,724, an air pocket may, for example, form and be raised towards a region surrounding the insertion tube or port 629 and/or opening 710, with blood flow moving out from the central container 420 towards the channels (e.g. the first channel 440, the second channel 441, and the third channel 442) but below the air pocket.
The top surface 631,725 may further comprise an insertion tube or port 629 with an insertion opening 630 extending through the insertion tube 629 and into the interior of the centrifuge container 610. The insertion tube or port 629 may be centered and/or aligned over a longitudinal axis of the fourth ring 419 and/or disposed in the center. Alternatively, it may be offset from the longitudinal axis of the fourth 419 and/or offset from the center. The insertion tube or port 629 may be disposed between a one or more extraction regions 606; the insertion tube or port 629 may be disposed between the first extraction region and a second extraction region. At least a portion of the container cover 625,704 may comprise a coating. At least a portion of the internal circumferential sidewall 628,736 may comprise a coating. The coating may comprise anticoagulants, preservatives, disinfectants or germicidal agents or pathogen reduction agents or pathogen inactivation agents, sterilants, antiseptics, clot activators, separator gels.
The top surface 631,724 may comprise an opening 710. The opening 710 may be sized an configured to receive a serum or plasma filter 714, a pipette or eye dropper 716, and/or filtered eye dropper 718. The opening 710 may further comprise a lid (not shown) and/or a seal (not shown), the lid or seal may be fixed and/or removably connected. The opening 710 may extend through the top surface 631,724 through the bottom surface 633,732. The opening 710 may be centered on the top surface 631,724.
In another embodiment, the container cover or centrifuge cover 625,704 may comprise at least one light or a plurality of lights (not shown). The at least one light or the plurality of lights comprises a fluorescent lamp (CFL), an incandescent bulb, a halogen bulb, a light emitting diode (LED) bulb, an ultra-violet (UV) light, and/or any combination thereof. Each of the plurality of lights may be the same or they may be different. The at least one light or the plurality of lights coupled or positioned adjacent to the top surface 631,724, a bottom surface 633,732, an external circumferential sidewall 627,734 and/or an internal circumferential sidewall 628,736 of the container cover 625,704.
The top surface 631,724 comprise a circular shape with the insertion tube or port 629 approximately concentric or centered with the top surface 631,724. The top surface 631,724 and the insertion tube or port 629 are configured (e.g. shaped and dimensioned) for the protective cover 601,702 placement over the centrifugal container 610 and/or the sequester wheel 405,706 without inhibiting rotation of the centrifuge container 610 and/or the sequester wheel 405,706. The top surface 631,724 may further comprise one or more extraction regions 606, the one or more extraction regions 606 are spaced apart. The one or more extraction regions 606 may be spaced apart symmetrically or non-symmetrically around the circumference of the top surface 631,724. For example, the top surface 631,724 has a first extraction region and a second extraction region, the first extraction region and the second extraction region are spaced apart and/or diametrically opposed. The top surface 631,724 may, for example, have an external circumferential sidewall 627,734, with the sidewall 627,734 extending away from the top surface 631,724 and connected to an outer rim 415 of the sequester device 405, 706. The centrifuge cover 625,704 connected to the sequester device 405,706 may, for example, form a cylindrical structure. The sequester device 405,706 has already been described in detail, and for the sake of brevity, will not be further described.
The one or more extraction regions 606, the first extraction region and/or the second extraction region comprises one or more activity indicators 621. The top surface 631,734 may, for example, also include a plurality of extraction hole regions (e.g. multiple instances of the extraction region 606) surrounded by a plurality of activity indictors (e.g. multiple instances of the activity indicator 621). The one or more extraction regions 606, the first extraction region and/or the second extraction region may comprise a shape, the shape may include a circle, an oval, a regular polygon shape and/or any combination thereof. The activity indicator 621 is shown as a circular shaped ring surrounding the extraction region 606. The activity indicator 621 may comprise a visual indicator. The visual indicator may comprise a different colored material and/or at least one light (e.g., LED).
Alternatively, the one or more extraction regions 606, the first extraction region and/or the second extraction region may comprise a plurality of extraction holes 637. The plurality of extraction holes 637 and/or each of the plurality of extraction holes 637 may be spaced apart and disposed within the one or more extraction regions 606. The plurality of extraction holes 637 may be spaced apart and axially aligned. The plurality of extraction holes 637 may be spaced apart and offset. However, the activity indicator 621 may be, for example, shaped and colored to bring visual attention to the extraction region 606. During centrifugation, the centrifuge container 610 and/or the sequester wheel 405,706 spins, also spinning the activity indicator 621. The activity indicator 621 may, for example, provide a visual indication that the centrifuge is spinning and that the protective cover 601 should remain on until the centrifugation process is complete.
There may be more than two extraction regions 606. The multiple instances of extraction region 606, the extraction holes 637, and multiple instances of the activity indicator 621 may, for example, be positioned to minimize vibration and balance rotation of the centrifuge container. A plurality of extraction regions (e.g. multiple instances of extraction region 606) may be on the top surface 631 of the centrifuge cover 625 and, for example, radially approximately equally spaced and in approximately equal intervals on the top surface 631 to minimize vibration and to maintain balanced rotation of the centrifuge container 610.
The container cover 625,704 and/or the protective cover 601,702 comprises a material. The container cover 625,704 and/or the protective cover 601,702 may further comprise a coating. The material may be a polymer and/or a metal. The material may also include an opaque, clear, transparent, and/or translucent material. The material may further comprise a color. The colorant may be used to diffuse the luminescence of the at least one light and/or the plurality of lights. The coating may comprise anticoagulants, preservatives, disinfectants or germicidal agents or pathogen reduction agents or pathogen inactivation agents, sterilants, antiseptics, clot activators, separator gels. The pathogen reduction agents or germicidal agents may comprise alcohols, chlorine dioxide, chlorine mixtures, formaldehyde, glutaraldehyde, hydrogen peroxide, Iodophor mixtures, peracetic acid, phenolic mixtures, quaternary ammonium mixtures, amotosalen or riboflavin, and/or any combination thereof. The pathogen reduction agents may be used alone and/or with combination of a UV light for enhanced pathogen reduction. The pathogens in whole blood or its blood components are inactivated by adding pathogen reducing agent and irradiating with UV light over a period of time, the period of time ranging from 5 to 90 minutes. This method reduces the infection levels of disease-causing agents by releasing active oxygen which damages the cell membrane of the pathogens and prevents replication of the carrier pathogens that may be found in whole blood or blood components for safer injection or transfusion. Pathogens may include viruses, bacteria, parasites, and/or white blood cells.
For example, in one embodiment, at least a portion of the container cover 625,704 and/or at least a portion of the protective cover 601,702 comprises a coating and at least one light. The coating includes germicidal agent, the germicidal agent is riboflavin. The at least one light includes a UV light, the UV light having a wavelength. The wavelength may comprise a range of 222 to 280 nanometers for proper activation of riboflavin to act as a germicidal agent. In another embodiment, the container cover 625,704 and/or the protective cover 601,702 comprises at least one light. The at least one light may be disposed onto a portion of the container cover 625,704 and/or the protective cover 601,702, the at least one light may comprise a UV light, the UV light having a wavelength. The wavelength is a range of 250 to 400 nanometers to act as a germicidal agent alone and a coating may not be required.
Referring to
Referring to
With reference to
The portable centrifuge 600,700 comprises a base 708, 730, the base 708,730 may comprise a motor 154. The motor 154 may be held in position or secured by a motor support wall 654. The support wall 654 may, for example, extend away from the baseplate 101 in an approximately perpendicular direction. The motor 154 is shown on the baseplate with the armature 161 extending out from the motor 154. The motor 154 may be, for example, positioned between two opposing sections of the support wall 654, such that the motor 154 is supported on two opposing sides.
In one embodiment, the base 708,730 of the portable centrifuge 600 may comprise at least one light or a plurality of lights 655. A light 655 may be, for example, positioned near or adjacent to the motor 154. Light 655 may be a single light source or a plurality of light sources. The light 655 may comprise a compact fluorescent lamp (CFL), an incandescent bulb, a halogen bulb, a light emitting diode (LED) bulb and/or an ultra-violet (UV) light. The light may be used as a visual indicator to inform the user of a started or completed centrifugation cycle, used to illuminate or provide a back light to the separated blood products for easier constituent selection and extraction. The UV light may also be used as a chemical free, highly effective disinfectant against harmful microorganisms. UV light includes a specific range of wavelengths within the UV-A, UV-B, or UV-C range that are categorized as germicidal—meaning they are capable of inactivating microorganisms, such as bacteria, viruses and protozoa (see
Accordingly, the base 708,730 may comprise a first light and a second light. The first light is different than the second light. The first and/or second light may comprise different color lights, different wavelengths, different bulb watts or different bulb sizes or diameters, different bulb types, different bulb types, different bulb intensities. For example, the first light being a violet colored LED bulb for a first visual indicator for activating the centrifugation process, the second light being a while colored LED bulb for a second visual indicator when the centrifugation cycle is complete. Another example includes a first light being an LED bulb type and the second light being a UV bulb type. Alternatively, the base 708,730 may comprise a first light, a second light and a third light. Each of the first, second and third lights are different from each other.
In another embodiment, the protective cover 601,704 and/or the container cover 625,702 may comprise at least one light 655. The at least one light 655 may be disposed onto an internal circumference sidewall 618 of the protective cover 601, 704 and/or the external sidewall 627,734 of the container cover or activation cover 103, 625, 702. The at least one light 655 may be disposed onto the top surface of the protective cover 601, 704 and/or the container cover 103, 625,702. Alternatively, the Accordingly, the protective cover 601,704 and/or the container cover 103, 625 may comprise a first light and a second light. The first light is different than the second light. The first and/or second light may comprise different color lights, different wavelengths, different bulb watts or different bulb sizes or diameters, different bulb types, different bulb types, different bulb intensities. For example, the first light being a violet colored LED bulb for a first visual indicator for activating the centrifugation process, the second light being a while colored LED bulb for a second visual indicator when the centrifugation cycle is complete. Another example includes a first light being an LED bulb type and the second light being a UV bulb type. Alternatively, the protective cover 601,704 and/or the container cover 103,625,702 may comprise a first light, a second light and a third light. Each of the first, second and third lights are different from each other.
In still further embodiments, the base 708,730 may comprise a base cover 102. The base cover 102 may have supports to secure the light 655. The light 655 may be, for example, positioned to shine light through the base cover opening 657. The armature 161 may be, for example, engaged with the armature hub 422 of the sequester device 405, and positioning the light 655 close to the motor 154 provides for light transmission into the centrifuge container 610. The centrifuge cover 625,702 and the sequester device 405,706 may, for example, be fabricated from a clear polymer plastic material or a material through which blood separation columns may be visible and through which emissions from the light 655 may be visible. The light 655 may, for example, be connected to a timer on the circuit board 151 which activates the light 655 when the centrifugation process is complete. The light 655 may display as continuously (e.g., “always on”) and/or it may be flashing, which flashing delivers quick bursts of light over a period of time.
Continuing with
With reference to
The portable centrifuge 600,700 may comprise a base 708,730, the base comprises a lock 654. The lock 654 may, for example, prevent the centrifuge 600 from being reactivated while the centrifuge container 610 is still spinning. The centrifugation process is timed, and reactivation may cause delays or may damage blood cells through repeated centrifugation.
With reference to
The portable centrifuge 600,700 may comprise a base 708,730, the base 708,730 comprises a brake 607. The brake 607 may be, for example, engaged to stop rotation of centrifuge container 610 and/or the sequester wheel 405,706 after the rotational mechanism 650 has been turned off. The brake comprises a brake pad 612. The brake pad 612 wedge shape may be, for example, configured (e.g. shaped and dimensioned) to match the conical slope of the top surface 631. Depressing the brake button 607 may, for example, push brake pad 612 against the top surface 631, frictionally slowing the centrifugal container. The brake 607 is movable from a first position to a second position, the first position comprising the brake pad 612 having no contact with the sequester device, and a second position comprising the brake pad 612 contacting or engaging the sequester device to slow the revolutions per minute (RPM) to a complete stop via friction.
With reference to
For centrifuges 100, 400, 500, and 600, the positioning of extraction holes (e.g. 121, 407, and 637) and extraction barriers (e.g. 443 and 643) may be to, for example, minimize vibrations and help balance centrifuge container rotation. In addition, activity indicator 621 may be applied to centrifuges 100, 400, 500, and 600 around the extraction holes (e.g. 121, 407, and 637) to form an extraction region.
Referring to
With continued reference to
Referring to
With reference to
In other aspects of the centrifuges 300, 400, 500, the rotational mechanism 110 may be used instead of rotational mechanism 330. If rotational mechanism 110 is use with centrifuges 300, 400, and 500, the solenoid 153 and thus solenoid armature 163 may be used to provide braking by triggering and extending the solenoid armature 163 to make contact with the rotor 312 or centrifuge container 430 or 330.
The protective cover 103 for the centrifuges 100, 400, and 500 is shown as clockwise twistable in
With reference to
With reference to
With reference to
Microfluidic Portable Centrifuge
Hemostatic disorders are both complex and costly in relation to both their treatment and subsequent management. There is an ever-increasing drive to improve the diagnosis and prevention of hemostatic disorders because traditional diagnostic methods contain various disadvantages. Various tests and devices have been developed over many decades to assess blood clotting and platelet function in-vitro, including assays for bleeding time, activated clotting time (ACT), activated partial thromboplastin time (aPTT), thromboelastography and platelet aggregometry.
While these traditional tests provide useful information regarding coagulation status or platelet function, they are limited in terms of their ability to predict thrombotic or bleeding risk in clinical settings at least in part because they fail to incorporate many of the key contributors to hemostasis control that exist in-vivo. For example, a major limitation of these assays is that they require extraction of large or exact volumes of blood by venipuncture and measure clotting behavior under static (no flow) or irrelevant flow conditions, and thus, they fail to incorporate the effects of hemodynamic forces (pressure, flow and shear stress) and related cellular interactions that are known to significantly impact whole blood thrombosis in the living vasculature. Notably, flow acceleration and deceleration (fluid shear gradients) have been shown to initiate platelet aggregation during arterial thrombosis in-vivo and clotting in extracorporeal devices usually occurs at sites of sudden flow disturbances, stagnation points and stenosed sections of tubing. However, none of the routinely used hemostasis assays incorporate these physiological conditions in their assessment of blood coagulation, as well as require expert/experienced personnel to perform the process and interpret the results.
As a result, point-of-care (POC) or similarly named nearly-patient-testing (NPT) is playing more of an important role in hemostasis diagnostic settings. A need remains to create or manufacture a detection method and apparatus for POC and/or NPT clotting time determination. The detection method and apparatus may comprise smaller and/or unmeasured whole blood samples, in the microliter scale, for rapid determination of clot-time while the whole blood is being centrifuged into its constituent components. Furthermore, such a detection method and apparatus can be used to determine the relative clotting/coagulation potential at the time of use, prophylactic actions could be taken to adjust the patients' medical treatment(s) to improve their healing potential. This can also be used as a relative research tool because doctors usually do not know how active the platelets are and if they have this knowledge, they could adjust other surgical interventions knowing how viable the platelets were at the time of use.
In one embodiment, the portable centrifuge comprises a microfluidic mechanism for POC, NPT or real-time monitoring of hemostasis that permits rapid determination of clotting time for whole blood as its perfused through at least one fluid channel (hereinafter the “microfluidic centrifuge). In another embodiment, the portable centrifuge comprises a microfluidic mechanism for POC, NPT or real-time monitoring of hemostasis that permits rapid determination of clotting time for whole blood as its perfused through at least one fluid channel (hereinafter the “microfluidic centrifuge) and/or perform centrifugation of whole blood into its constituent components. The microfluidic centrifuge may further comprise a plurality of fluid channels that mimics local physiologic relevant changes in hemodynamic flow conditions experienced in living stenosed arterioles.
Microfluidic mechanisms offer several benefits over conventional detection methods. Microfluidic mechanisms exploit the physical and chemical properties of liquids and gases at a microscale, and allow the analysis and use of less volume of samples, chemicals and reagents reducing the global fees for analysis. Many microfluidic mechanisms can be executed at the same time due to their compact size, while shortening the time of experiment. They also offer an excellent data quality and substantial parameter control which allows process automation while preserving its performance. The microfluidic chip allows the user to generate multi-step analysis requiring low level of expertise and a lot of functionalities.
In another embodiment, the microfluidic centrifuge (or portable centrifuge with microfluidic mechanism) could determine coagulation by whole blood flowing into the at least one fluid channel via capillary action or flow pressure. Upon entry of the whole blood into the at least one channel would yield a relative clotting potential based on time and differential pressure induced by the portable centrifuge. The relative clotting/coagulation potential would be measured and/or calibrated against laboratory settings to initially determine its accuracy.
With reference to
In another embodiment, the portable centrifuge 738, 744 comprises a plurality of coagulation modules 760 (for spinning balance) to determine coagulation or clot-time as shown in
The entire portable centrifuge 738,744 can be completely sterile, and single use. If the entire portable centrifuge is single use, the entire portable centrifuge is used once and then disposed appropriately. Alternatively, a portion of the entire portable centrifuge, 738,744 can be sterile, and single use. If a portion of the portable centrifuge 738,744 is single use, a portion of the portable centrifuge 738,744 is used only once then discarded appropriately, and the remaining portion may be re-used again. In one embodiment, a portion of the portable centrifuge 738,744 comprises the sequester device and the container cover 740,746 being single use, and the protective cover and the base re-useable. In another embodiment, a portion of the portable centrifuge 738,744 comprises the sequester device 405,706, the container cover 740,746 and protective cover being single use, and the base re-useable.
Referring to
The top surface 748 may comprise a circular shape with the insertion tube or port 752 with an opening 754 approximately concentric or centered with the top surface 748. The top surface 748 and the insertion tube or port 752 are configured (e.g., shaped and dimensioned) to receive the protective cover without inhibiting rotation of the sequester device and/or the sequester wheel. The top surface 748 may further comprise one or more extraction regions 756, the one or more extraction regions 756 are spaced apart. The one or more extraction regions 756 may be spaced apart symmetrically or non-symmetrically around the circumference of the top surface 748. For example, the top surface 748 has a first extraction region and a second extraction region, the first extraction region and the second extraction region are spaced apart and/or diametrically opposed. The top surface 748 may, for example, have an external circumferential sidewall 750, with the sidewall 750 extending away from the top surface 748 or extending downward and connected or contacting an outer rim of the sequester device.
The one or more extraction regions 756, the first extraction region and/or the second extraction region may further comprise one or more activity indicators (not shown). The top surface 748 may also include a plurality of extraction hole regions (e.g., multiple instances of the extraction region 756) surrounded by a plurality of activity indictors (e.g., multiple instances of the activity indicators). The one or more extraction regions 756, the first extraction region and/or the second extraction region may comprise a shape, the shape may include a circle, an oval, a regular polygon shape and/or any combination thereof.
Alternatively, the one or more extraction regions 756, the first extraction region and/or the second extraction region may comprise a plurality of extraction holes 758. The plurality of extraction holes 758 and/or each of the plurality of extraction holes 758 may be spaced apart and disposed within the one or more extraction regions 756. Alternatively, the plurality of extraction holes 758 may be spaced apart and disposed onto the top surface 748 of the container cover 740. The plurality of extraction holes 758 may be spaced apart and axially aligned. The plurality of extraction holes 758 may be spaced apart and offset. Alternatively, each of the plurality of extraction holes 758 may be spaced apart and axially aligned, and/or each of the plurality of extraction holes 758 may be spaced apart and offset. However, the activity indicator may be, for example, shaped and colored to bring visual attention to the extraction region 756 and/or may be positioned adjacent to the extraction region 756 and/or the plurality of extraction holes 758. During centrifugation, the container cover 740 and/or the sequester wheel spins, also spinning the activity indicator. The activity indicator may, for example, provide a visual indication that the centrifuge is spinning and that the protective cover should remain on until the centrifugation process is complete.
The container cover 740,746 may further comprise one or more coagulation modules 760. The container cover 740,746 includes a top surface 748 and a bottom surface (not shown). The top surface 748 may further comprise one or more coagulation modules 760. The one or more coagulation modules 760 are spaced apart. The one or more coagulation modules 760 may be spaced apart symmetrically or non-symmetrically around the circumference of the top surface 748. For example, the top surface 748 has a first coagulation module and a second coagulation module, the first coagulation module and the second coagulation module are spaced apart and/or diametrically opposed. The one or more coagulation modules 760, the first coagulation module and/or the second coagulation modules 760 are disposed above and/or below the top surface 748 of the container cover 740, 746. At least a portion of the one or more coagulation modules 760, at least a portion of the first coagulation module and/or at least a portion of the second coagulation modules 760 are disposed above and below the top surface 748 of the container cover 740, 746. The one or more coagulation modules 760, the first coagulation module and/or the second coagulation modules 760 comprises at least one surface that is even and/or flush with the top surface 748 of the container cover 740, 746. At least a portion of the one or more coagulation modules 760, at least portion of the first coagulation module and/or at least a portion of the second coagulation modules 760 comprises at least one surface that extends above the top surface 748 of the container cover 740,746.
The one or more coagulation modules 760 comprise at least one microfluidic mechanism 762 and/or microfluidic chamber and/or one or more blood communication ports 766a, 766b. The coagulation modules 760 may further comprise at least one clotting potential region or clotting indicator 764a, 764b, 764c. The at least one microfluidic mechanism or microfluidic chamber 762 comprises a volume, shape and a configuration that would allow a fluid and/or whole blood into the at least one microfluidic mechanism or chamber 762 by capillary action and/or by flow induced by the differential pressure of the centrifuge. The one or more blood communication ports 766a, 766b may comprise an inlet 766a and an outlet 766b. In one embodiment, the one or more coagulation modules 760 may comprise a clotting potential action or a clotting driving force. Clotting potential, the clotting potential action and/or the clotting driving force of the one or more coagulation modules 760 may be provided by capillary action or differential pressure action. The capillary action may typically involve laminar flow, which the clotting potential is based the diffusion rate of the media. Clotting potential or clotting driving force based on flow induced by centrifugal forces is governed by a pressure differential caused by rotating the portable centrifuge at defined speeds resulting in centrifugal forces that are at different points within the portable centrifuge, including at a radii (point A) radii or different distances than at radii (point B) within the sequester wheel or device and/or container cover 740, 746. Thus, blood clotting time or a blood clotting potential can be measured by monitoring the change in viscosity of the fluid or blood over time.
Upon entry of the whole blood through one or more blood communication ports 766a, 766b into the at least one microfluidic mechanism or chamber 762 would yield a relative clotting potential based on time and differential pressure induced by the portable centrifuge. The relative clotting/coagulation potential would be measured and/or calibrated against laboratory settings to initially determine its accuracy. The relative clotting potential may be correlated to the at least one clotting region or clotting indicator 764a, 764b, 764c for easy visual determination of clot time. The at least one clotting region or clotting indicator 764a, 764b, 764c may comprise at least one indicator descriptor. The clotting time may be measured using at least one indicator descriptor, the at least one indicator descriptor may include a relative time, a clotting description, a color, and/or any combination thereof.
For example, the clotting descriptors may include numbers or words that describe a relative time. Using “1” may be perceived as high clotting potential that occurred at a lowest amount of time than expected or compared to clinical clotting times, “2” may be perceived as normal clotting potential that occurred at a normal expected time or a normal clinical clotting time, and/or “3” may be perceived at low clotting potential that occurred at a longer clotting time than expected or compared to clinical clotting times. Alternatively, region 1 may use the word “high clot time,” region 2, may be “average or normal clot time,” and region 3 may be “low clot time.”
The coagulation module 760 comprises a top surface 768, a bottom surface 770, and at least one microfluidic mechanism or chamber 762. The at least one microfluidic mechanism or chamber 762 disposed between the top surface 768 and the bottom surface 770. The at least one microfluidic mechanism or fluid chamber 762 is planar or substantially planar (meaning 0.25 to 10 degrees from planar). The at least one microfluidic mechanism or microfluid chamber 762 is parallel to the top surface 768 of the container cover. The bottom surface 770 comprises at least one blood communication port 766a, 766b. Alternatively, the bottom surface 770 comprises a first blood communication port 766a and a second blood communication port 766b. Accordingly, the bottom surface 770 comprises an inlet 766a and an outlet 766b. The first blood communication port 766b or outlet 766b is proximate to the center or central axis or longitudinal axis 830 of the centrifuge and the second blood communication port 766a or the inlet 766a is proximate to the outer channel or outer perimeter 750 of the container cover 740, 746 and/or the sequester wheel. The first blood communication port 766b and/or outlet 766b is in fluid communication with the at least one microfluidic chamber 762 allowing exit of blood or fluid. The second blood communication port 766a and/or the inlet 766a is in fluid communication with the at least one microfluidic chamber 762 allowing the entry of blood or fluid. The first blood communication port 766a is spaced apart from the second blood communication port 766b. The first blood communication port or outlet 766b is axially aligned 832 with the second blood communication port or inlet 766a. Alternatively, the first blood communication port or outlet 766b is not axially aligned 832 with the second blood communication port or inlet 766a.
The coagulation module 760, the top surface 768 and the bottom surface 770 comprises a material. The coagulation module 760, the top surface 768 and the bottom surface 770 may further comprise a coating. The material may be a glass/ceramic, polymer and/or a metal. The polymer materials may comprise polydimethylsiloxane (PDMS), polymethylmethacrylate (PMMA), polystyrene (PS), polycarbonate (PC), polyethylene terephthalate (PET), polytetrafluoroethylene ethylene (PTFE) and other materials known in the art for fabricating microfluidic channels or chambers 762.
The material may also include an opaque, clear, transparent, and/or translucent material. The material may further comprise a color. The colorant may be used to diffuse the luminescence of the at least one light and/or the plurality of lights. The top surface material of the coagulation module 670 may be the same as the bottom surface material of the coagulation module 770. The top surface material of the coagulation module 670 may be different as the bottom surface material of the coagulation module 770. The top surface 768 of the coagulation module 760 may comprise magnification.
The coating may comprise anticoagulants, preservatives, disinfectants or germicidal agents or pathogen reduction agents or pathogen inactivation agents, sterilants, antiseptics, clot activators, separator gels. The pathogen reduction agents or germicidal agents may comprise alcohols, chlorine dioxide, chlorine mixtures, formaldehyde, glutaraldehyde, hydrogen peroxide, Iodophor mixtures, peracetic acid, phenolic mixtures, quaternary ammonium mixtures, amotosalen or riboflavin, and/or any combination thereof. The pathogen reduction agents may be used alone and/or with combination of a UV light for enhanced pathogen reduction. The pathogens in whole blood or its blood components are inactivated by adding pathogen reducing agent and irradiating with UV light over a period of time, the period of time ranging from 5 to 90 minutes. This method reduces the infection levels of disease-causing agents by releasing active oxygen which damages the cell membrane of the pathogens and prevents replication of the carrier pathogens that may be found in whole blood or blood components for safer injection or transfusion. Pathogens may include viruses, bacteria, parasites, and/or white blood cells.
Referring to
Referring to
The channel cross-sectional shape 784 may comprise a rectangular or circular shape as described in
Referring to
Referring to
In one embodiment, the at least one microfluidic mechanism 780 further comprises one or more valves (not shown). The one or more valves may be integrated or removably attached. The one or more valves may be normally closed. The burst or opening of a normally closed passive valve is triggered by a centrifugal pressure, capillary forces, and/or the instability of a liquid/gas interface (hydrophobic barrier or a burstable seal). The valve may be movable from a first position to a second position, the first position comprises a “closed” position prevent fluid flow or blood flow, and the second position is the “open” position to allow fluid flow or blood flow. To pass or open the one or more valves, the forces or pressure has to exceed the counter pressure exhibited by the one or more valves. The one or more valves may be disposed at the inlet and/or the outlet. The one or more valves may be disposed between the inlet and the outlet, and/or the one or more valves may be disposed anywhere along the length of the at least microfluidic mechanism 780.
The coagulation modules 760 may be manufactured by standard methods known in the art. Such methods may include photolithography, soft lithography, thermoforming, casting, injection molding, embossing, and imprinting techniques, wet and dry etching methods, laser-based micromachining techniques, 3D printing and/or any combination thereof. In addition, other methods may be contemplated, such as solid wax and inkjet printing.
Stem Cell Isolation
The portable centrifuge 896, 934 may be used and/or adapted to isolate different types of stem cells and/or cell types from mesenchymal stem cells (MSC), mononuclear cells (MNCs) and/or stromal vascular fraction (SVF) from different types of tissues for on-site or same day therapeutic and/or regenerative treatment purposes. MSCs or stromal cells can be isolated from different tissues, which include adipose tissue, tendons, periodontal ligament, synovial membranes, trabecular bone, bone marrow, embryonic tissue, the nervous system, skin, periosteum, muscle, peripheral blood, and/or any combination thereof. Accordingly, MNCs can be isolated from tissues, including bone marrow, umbilical cord, peripheral blood, and/or spleen. Furthermore, SVF is a heterogenous mixture of cells isolated by enzymatic or non-enzymatic dissociation of the lipoaspirate obtained from liposuction of excess adipose tissue that contains a large population of adipose derived stem cells (ADSCs), and other types of cells (e.g., endothelial cells, erythrocytes, fibroblasts, lymphocytes, monocytes, pericytes, etc.).
In another embodiment, the portable centrifuge 896, 934 can isolate peripheral blood mononuclear cells (PBMCs) from peripheral blood and/or isolate stem cells from PBMCs. PBMCs are blood cells with round nuclei that encompass a heterogeneous cell population comprising various amounts of lymphocytes (T cells, B cells, and NK cells), dendritic cells, and monocytes. These cells are critical components of the innate and adaptive immune system which defends the body against viral, bacterial, and parasitic infection and destroys tumor cells and foreign substances. PBMCs can be isolated by density gradient centrifugation, as different components of the blood have different densities and can be separated accordingly allowing the portable centrifuge to operate at a constant rotational speed for set time based on the organelles sedimentation rate. Further processing known in the art may be used with the portable centrifuge and/or other techniques to facilitate isolation of stem cells, MSC's from the isolated MNCs.
In another embodiment, the portable centrifuge 896, 934 can isolate SVF from adipose tissue using enzymatic and/or non-enzymatic techniques and/or isolate stem cells from SVF. As described herein, SVF cells are obtained through liposuction and contain multiple cell types, including adipose-derived stem cells (ADSCs) with potential tissue regenerative activity. Upon isolation and processing, the adipose-derived SVF cells can differentiate into different tissue types, support neovascularization, replace cells and repair injured issue. Further processing known in the art may be used with the portable centrifuge and/or other techniques to facilitate isolation of stem cells, other cell types, and/or MSC's from the SVF.
In another embodiment, the portable centrifuge 896, 934 can isolate mononuclear cells (MNCs) and mesenchymal stem cells (MSCs) from bone marrow and/or stem cells from MNCs or MSCs. BM-MSC isolation procedures may use density centrifugation with a density medium to separate the mononuclear cell (MNC) fraction from the other marrow constituents (i.e., red blood cells, plasma, lipids). This MNC fraction contains an enriched population of T-cells, B-cells, monocytes, hemopoetic stem cells (HSCs), endothelial progenitor cells and MSCs. The BM-MSCs are further isolated via plating onto tissue culture flasks. BM-MSCs are an attractive therapeutic tool due to their potential to be differentiated into a variety of cell types and their immunosuppressive properties. Their application is being explored in cell transplantation, regenerative therapy, correcting genetic disorders, diseases, and tissue engineering. Further processing known in the art may be used with the portable centrifuge and/or other techniques to facilitate isolation of stem cells and/or other cell types.
In one embodiment, the portable centrifuge 896, 934 comprises: a protective cover (not shown), a container cover 898, 940, a sequester wheel or sequester device 838, 900 and a base 904. The base 904 comprises a rotational mechanism (not shown). The base 904 may further comprise a base plate (not shown), and a base cover (not shown). The portable centrifuge 896, 934 may further comprise at least one or more of: a disaggregating mechanism 866, 868, 870, 872, disaggregating elements 874a, 874b, 876, 878, 880, an agitation mechanism (not shown), an incubator 940, 942, 944, 952, a filtration ring 902, one or more blister modules 906a, 906b, at least one reagent 938 and/or any combination thereof. The protective cover, the container cover 898, 940, the sequester device 838, 900, the base 904, rotational mechanism, base plate, the base cover and/or many other features have already been described in detail in the above paragraphs, and for the sake of brevity, those features will not be further described, unless new features are identified below.
In one embodiment, the portable centrifuge 896, 934 comprises a container cover 898, 940. The container cover 898, 940 may further comprise at least one blister module 906a, 906b. The container cover 898, 940 may be disposed over a portion of a sequester device 838, 900. The container cover 898, 940 comprises a top surface 901, a bottom surface (not shown), an external circumferential sidewall 903 that creates an opening or recess. The container cover 898, 940 may further comprise an internal circumferential sidewall (not shown). The container cover 898, 940 may comprise a top surface 901 that comprises a flat or planar, domed or conical shape. The container cover 898, 940 comprises a circular cross-sectional shape and/or it has a cylindrical shape. The top surface 904 and the insertion tube or port 910 are configured (e.g., shaped and dimensioned) to receive the protective cover without inhibiting rotation of the sequester device and/or the sequester wheel.
With reference to
The container cover 898, 940 may further comprise one or more blister modules 908a, 908b as shown in
The chamber 917 and/or container 912 is movable from a first position that is uncompressed with the chamber 917 filled with the at least one reagent 916 to a second position that is compressed breaking the frangible base 914 and/or and the at least one reagent 916 is in fluid communication with an opening (not shown) disposed onto the centrifuge container cover 898, 940 to dispense the at least one reagent 916 into the sequester device 838, 900. The at least one opening disposed on the centrifuge container cover 898, 940 comprises a seal (not shown), the seal should self-seal after being in fluid communication with the at least one reagent 916 and/or the at least one reagent forces or pushes the seal to open to allow the at least one reagent 916 to be dispensed into the sequester device 838, 900. Compressing the chamber 917 and the container 912 filled with the at least one reagent 916 should comprise sufficient pressure to overcome the seal to allow the at least one reagent 916 to be in fluid communication with the opening and the sequester device 838, 900. Alternatively, the at least one blister module 906a, 906b is movable from a undispensed position with the at least one blister module 906a, 906b filled with at least one reagent 916, and a dispensed position with the blister module 906a, 906b unfilled or empty after the at least one blister module 906a, 906b is compressed or depressed. The blister container 912 may comprise a material known in the art for dispensing a liquid or a solid. The blister module 906a, 906b and/or container 912 may comprise and/or be filled with at least one or more reagents 916.
The at least one reagent 916 may comprise solids and/or liquids. The liquids may include any pharmaceutical, chemical, solution, reagents and/or any combination thereof. The one or more reagents 916 may include saline; phosphate buffered saline (PBS); digestion enzyme, erythrolysis buffer, thixotropic gels, anticoagulants, density gradient media, buffer, dilution media and/or any combination thereof. The digestion enzyme comprises collagenase Type I-IV, dipase, trypase and/or any combination thereof. The density gradient media comprises FICOLL-PAQUE, PANCOLL, PERCOLL, LYMPHOPREP, a polyester thixotropic gel, separation gel, and/or any combination thereof. Anticoagulants comprises sodium citrate, sodium heparin, and ACD-A.
With reference to
In another embodiment, the sequester device 838, 900 comprises a first concentric ring 840, 918 including a first height 850 and first diameter, a second concentric ring 842, 920 including a second height 852 and a second diameter, and a third concentric ring 844, 922 having a third height 854 and a third diameter. The first concentric ring 840, 918 forms the central container 848, 926. The third diameter is larger than the second diameter and the second diameter is larger than the first diameter; each of the concentric rings 840, 842, 844, 918, 920, 922 are tiered 860. Each of the first, second and third concentric rings 840, 842, 844, 918, 920, 922 are spaced apart from each other, the spacing forming a plurality of channels 858a, 858b, 858c, 928, 930, 932. Tiering 860 may comprise a 15 degree to 60 degree angle; it may comprise a 15 degree to 45 degree angle; or a 15 degree to 30 degree angle; or a 30 degree to 45 degree angle. In another embodiment, the sequester device 838, 900 comprises a first concentric ring 840, 918 including a first height 850 and first diameter, a second concentric ring 842, 920 including a second height 852 and a second diameter. The first concentric ring 840, 918 forms the central container 848, 926. The second diameter is larger than the first diameter; each of the concentric rings 840, 842 are tiered 860. In another embodiment, the sequester device 838, 940 comprises a first concentric ring 840, 918, a second concentric ring 842, 920, a third concentric ring 844, 922, and a fourth concentric ring 846, 924. The fourth concentric ring 846, 924 is larger than the third concentric ring 844, 922, the third concentric ring 844, 922 is larger than the second concentric ring 842, 920, and the second concentric ring 842, 920 is larger than the first concentric ring 840, 918. Each of the first, second, third and fourth concentric rings 840, 842, 844, 846, 918, 920, 922, 924 are concentric to each other, and they are tiered 860. The fourth concentric ring 846, 924 includes a fourth diameter and a fourth height 856.
In another embodiment, at least one or more of the first 840, 918 the second 842, 920 third concentric ring 844, 922 and/or fourth concentric ring 846, 924 may comprise one or more filtration rings 902 as shown in
In another embodiment, the spacing and/or channels 858a, 858b, 858c, 928, 930, 932 disposed between at least one of the first 840, 918, second 842, 920 and/or third concentric rings 844, 922 may comprise one or more reagents 938 as shown in
With reference to
The central element comprises a shape, the shape is a straight cylinder or a frustum shaped cylinder. The one or more central elements may comprise a plurality of cylinders stacked on top of each other as shown in
The disaggregating features 874a, 874b, 876, 878, 880 may comprise at least one cutting disc 874a, 874b, and/or a plurality of teeth or facets 876, 878, 880 that extend obliquely from the outer diameter of the central element and/or extend away from the outer diameter or external surface of the central element and/or disaggregating mechanism 866. The disaggregating features 874a, 874b, 876, 878, 880 may further comprise sharp edges that extend along a length of the central element and/or the disaggregating mechanism 866. The disaggregating features 874a, 874b, 876, 878, 880 may further comprise sharp edges that extend along at least a portion of the central element and/or disaggregating mechanism 866. The sharp edges may be straight or in a non-straight pattern as shown in
In another embodiment, at least a portion of the at least one of the concentric rings 840, 842, 844, 846, 918, 920, 922, 924 comprises disaggregating features disposed 874a, 874b, 876, 878, 880. The disaggregating features 874a, 874b, 876, 878, 880 onto at least a portion of at least one of a top surface, an inner diameter and/or an outer diameter of at least one of the concentric rings 840, 842, 844, 846, 918, 920, 922, 924 within the sequester device (not shown) 838, 900. The disaggregating features 874a, 874b, 876, 878, 880 may comprise at least one cutting disc 874a, 874b, and/or a plurality of teeth or facets 876, 878, 8880 that extend obliquely from the inner diameter and/or outer diameter of the central element and/or extend away from the at least one of a top surface, the inner diameter, the outer diameter of the concentric rings. The disaggregating features 874a, 874b, 876, 878, 880 may comprise sharp edges that extend away and/or extend obliquely from the at least one of the top surface, the inner diameter and/or outer diameter. The sharp edges may be straight or in a non-straight pattern as shown in
The disaggregation mechanism 866 may comprise a nanofat emulsifier 886 to grind, mince, cut, emulsify the lipoaspirate. The nanofat emulsifier 886 may be integrated within portable centrifuge 896, 934 and/or a modular mechanism that can be removably connected. Alternatively, it can be a separate nano-fat emulsifier provided as part of a kit, such as the Autologous Cellular Matrix Device (ACM) manufactured by Tulip Medical Systems, San Diego, CA for Healean Medical, Newport Beach, CA or the Tulip GEMS by Tulip Medical Systems, San Diego, CA. The lipoaspirate may be transferred to one or more luered syringes 890a, 890b to engage in standard protocol for one or more emulsification of adipose tissue by shifting of fat between two luered syringes 890a, 890b connected to each other by a transfer connector 888, mini transfer connectors 892a, 892b, 892c and/or filtration cartridges 894. The mini transfer connectors 892a, 892b, 892c includes sizes of a 1.2 mm, a 1.4 mm and/or a 2.4 mm. The lipoaspirate is manually transferred between the two syringes 890a, 890b through the first transfer connector 888 at least 30 times. Then manually transferred between the two syringes through a second transfer connector 892a, 892b, 892c at least 30 times. The second transfer connector may comprise a smaller filtration mesh than the first transfer connector.
The disaggregation mechanism 866 may comprise a nanofat emulsifier 886 that may be coupled to the portable centrifuge 896, 934. The nanofat emulsifier may further include a luer port connector. The luer port connector may be disposed onto the luer port and/or insertion hole of the container cover 898, 940 of the portable centrifuge 896, 934. The luer port connector allows the transfer connector 888 and/or the mini transfer connectors 892a, 892b, 892c to be coupled together to dispense and/or inject the lipoaspirate through the transfer connectors 888, 892a, 892b, 892c into the luer port and/or insertion hole to fill the central container 848, 926 with the emulsified lipoaspirate.
The portable centrifuge 896, 934 may further comprise an agitation mechanism (not shown). The agitation mechanism may facilitate the washing step and/or the digestion step once the enzyme is introduced. The agitation mechanism may provide at least one action, which includes shaking, vortexing, sonication, vibration and/or any combination thereof. The agitation mechanism may allow for a set frequency and a set time. The agitation mechanism may be integral with the portable centrifuge or a separate mechanism. The agitation mechanism may be disposed within the base. Alternatively, the washing step and/or the digestion step may be further completed by the rotational mechanism at a set speed (rpm) and/or a set time.
The portable centrifuge 896, 934 may further comprise one or more incubators and/or heaters 940, 942, 944, 952. The one or more incubator or heaters 940, 942, 944, 952 may comprise electrical heaters 944, hydroponic heaters, radiator heaters, oil-based heaters, chemical heaters 940, 942 and/or any combination thereof. Electrical heaters may comprise a light bulb (e.g., incandescent, fluorescent or halogen) (not shown), a 5 W ceramic resistor (not shown), electrical heating elements (coils or wires or plates) 944 and/or any combination thereof. The chemical heater may comprise magnesium and/or magnesium-iron, air-activated heater (zinc with activated carbon and other solvents), and/or hydrogen-free ration heater (HRH). The magnesium-iron heater activates with an exothermic reaction as soon as it comes in contact with water. The water dissolves the sodium chloride into an electrolyte solution causing magnesium and iron to function as an anode and cathode, respectively. The incubator and/or heater 940, 942, 944, 952 may further comprise thermometer. In another embodiment, the incubator and/or heater 940, 942, 944, 952 may further comprise at least one or more of a thermometer, a heater control dial, and a temperature display. The incubator and/or heater 940, 942, 944, 952 may be disposed within the base. Accordingly, the incubator and/or heater 940, 942, 944, 952 may be disposed on the top of the base, the incubator and/or heater 940, 942, 944, 952 between the base 904 and the sequester device 838, 900. Alternatively, the incubator and/or heater 940, 942, 944, 952 may be disposed within the container cover 898, 940 and/or the protective cover. The incubator and/or heater 940, 942, 944, 952 may be disposed onto at least one surface of the container cover 898, 940 and/or the protective cover. The incubator and/or heater 940, 942, 944, 952 may be disposed on top of the sequester device 838, 900, which is between the sequester device 838 and the container cover 898, 940.
In another embodiment, the one or more incubator and/or heaters 940, 942, 944, 952 may comprise one or more pads (not shown) that attaches and/or surrounds at least a portion the perimeter and/or at least a portion of the outside diameter of the sequester device 838, 900 as shown as
In another embodiment, the incubator and/or heater 940, 942, 944, 952 may further comprise one or more sleeves 952 that surrounds the perimeter and/or outside diameter of the sequester device 838, 900 as shown in
The portable centrifuge may further comprise modular filters. The modular filters may be disposed and/or coupled onto the central luer port on the container cover, a syringe, a pipette, and/or any combination thereof. The modular filters may comprise cannulas or needles with filters, cell strainers (e.g., FALCON cell strainer from Corning Inc. in Corning, NY), pipette tips with filters (e.g., FLOWMI cell strainer tips from Bel-Art-SP Scienceware in Wayne, NJ), syringe filters (e.g., TITAN, TARGET or CHOICE syringe filters from ThermoFisher Scientific in Waltham, MA). The modular filter may comprise a filter size, the filter size includes a 40 micrometer to 100 micrometer filter; a 40 micrometer to 90 micrometer filter; a 60 micrometer to 80 micrometer filter; a 70 micrometer to 80 micrometer filter. In an exemplary embodiment, the modular filter comprises a 70 micrometer filter.
Methods
In one embodiment, a method of separating blood into blood components comprises the steps of: removing a protective cover from a portable centrifuge, the protective cover having an activation tab, the portable centrifuge comprising a rotational mechanism, an activation switch, and a timer; injecting whole blood through an injection tube disposed onto a container cover into a central container within the portable centrifuge; activating the portable centrifuge by replacing the protective cover over the container cover and the activation tab of the protective cover contacting the activation switch to trigger rotation of the rotation mechanism and the timer; separating the blood into constituent components into a plurality of channels; removing the protective cover after the rotation ceases; and extracting the blood constituent components through the container cover.
In an alternate embodiment, a method of separating blood into blood components comprises the steps of: injecting whole blood through an injection tube disposed onto a container cover and/or a protective cover into a central container of the sequester wheel; disposing a protective cover over a portion of the sequester wheel to activate the rotation mechanism and the timer; separating the blood into constituent components into a plurality of channels; removing the protective cover after the rotation ceases; and extracting the blood constituent components from one or more extraction regions through the container cover.
In an alternate embodiment, a method of separating blood into blood components for treatment of ocular disorders comprises the steps of: injecting whole blood through an injection tube disposed onto a container cover and/or a protective cover into a central container of a sequester wheel; disposing a protective cover over a portion of the sequester wheel to activate the rotation mechanism and the timer; separating the blood into constituent components into the central container and at least one channel; removing the protective cover after the rotation ceases; inserting a serum filter through the opening of the container cover to filter the blood constituent component deposited within the central container and extracting the blood constituent components through the opening of the container cover for ocular application. Extracting may include a pipette, eye dropper, a syringe, and/or any mechanical or non-mechanical eye dispensing mechanisms known in the art.
In an alternate embodiment, a method of separating blood into blood components for treatment of ocular disorders comprises the steps of: injecting whole blood through an injection tube disposed onto a container cover and/or a protective cover into a central container of a sequester wheel; disposing a protective cover over a portion of the sequester wheel to activate the rotation mechanism and the timer; separating the blood into constituent components into the central container and at least one channel; removing the protective cover after the rotation ceases; inserting a eye dispenser comprising an integral serum filter through the opening of the container cover to filter and extract the blood constituent component deposited within the central container and removing the eye dispenser mechanism comprising an integral serum filter through the opening of the container cover for ocular application.
In an alternate embodiment, a method of separating blood into blood components and reducing pathogens comprises the steps of: injecting whole blood through an injection tube disposed onto a container cover and/or a protective cover into a central container of a sequester wheel; activating the portable centrifuge by positioning the protective cover over the container cover to activate the rotation of the rotation mechanism, the timer and the UV light; separating the blood into constituent components into a plurality of channels; disinfecting the blood constituent components during rotation by using the irradiation of the UV light; removing the protective cover after the rotation ceases; and extracting the disinfected blood constituent components through at least one of the extraction regions on the container cover.
In another embodiment, a method of separating blood into blood components and reducing pathogens comprises the steps of: injecting whole blood through an injection tube disposed onto a container cover and/or protective cover into a central container within the portable centrifuge; activating the portable centrifuge by positioning the protective cover over the container cover to activate the rotation of the rotation mechanism, the timer and a UV light; separating the blood into constituent components into a plurality of channels and the central container; disinfecting the constituent components during rotation using the irradiation of the UV light to activate a pathogen reduction coating deposited on at least one surface of the central container and a plurality of channels; removing the protective cover after the rotation ceases; and extracting the disinfected blood constituent components through at least one of the extraction regions on the container cover.
In another embodiment, a method of separating blood into blood components and reducing pathogens for treatment of ocular disorders comprises the steps of: injecting whole blood through an injection tube disposed onto a container cover and/or protective cover into a central container within the portable centrifuge; activating the portable centrifuge by positioning the protective cover over the container cover to activate the rotation of the rotation mechanism, the timer and a UV light; separating the blood into constituent components into the central container; disinfecting the constituent components during rotation using the irradiation of the UV light to activate a pathogen reduction coating deposited on at least one surface of the central container; removing the protective cover after the rotation ceases; inserting a serum filter through the opening of the container cover to filter the blood constituent component deposited within the central container; and extracting the disinfected and filtered blood constituent components through the container cover.
In another embodiment, a method of separating blood into blood components and reducing pathogens for treatment of ocular disorders comprises the steps of: injecting whole blood through an injection tube disposed onto a container cover and/or protective cover into a central container within the portable centrifuge; activating the portable centrifuge by positioning the protective cover over the container cover to activate the rotation of the rotation mechanism, the timer and a UV light; separating the blood into constituent components into the central container; disinfecting the constituent components during rotation using the irradiation of the UV light to activate a pathogen reduction coating deposited on at least one surface of the central container; removing the protective cover after the rotation ceases; and inserting an eye dispensing mechanism with an integral filter through the opening of the container cover to filter and extract the disinfected and filtered blood constituent component deposited within the central container.
In another embodiment, a method of separating blood into blood components and reducing pathogens for treatment of ocular disorders comprises the steps of: injecting whole blood through an injection tube disposed onto a container cover and/or protective cover into a central container within the portable centrifuge; activating the portable centrifuge by positioning the protective cover over the container cover to activate the rotation of the rotation mechanism, the timer and a UV light; separating the blood into constituent components into the central container; disinfecting the constituent components during rotation using the irradiation of the UV light to activate a pathogen reduction coating deposited on at least one surface of the central container; removing the protective cover after the rotation ceases; inserting a serum filter through the opening of the container cover to filter the blood constituent component deposited within the central container; and extracting the disinfected and filtered blood constituent components through the container cover.
In another embodiment, a method of calculating a specific volume of PRP/RBCs prior to separation of blood into blood components comprises the steps of: acquiring hematocrit (HCT) from a patient (i.e., HCT measures the volume of packed red blood cells (RBC) relative to the whole blood); selecting a total volume of blood to inject into the portable centrifuge; calculating PRP/RBC volume by multiplying the total volume of blood with HCT and calculating plasma volume by subtracting the total volume of blood from the PRP/RBC volume; removing a protective cover from a portable centrifuge, the protective cover having an activation tab, the portable centrifuge comprising a rotational mechanism, an activation switch, and a timer; injecting the selected total volume of whole blood through an injection tube disposed onto a container cover into a central container within the portable centrifuge; activating the portable centrifuge by replacing the protective cover over the container cover and the activation tab of the protective cover contacting the activation switch to trigger rotation of the rotation mechanism and the timer; separating the whole blood into constituent components into a plurality of channels; removing the protective cover after the rotation ceases; and extracting the calculated blood constituent components through the container cover. Using HCT to calculate the necessary volume of blood to be drawn from a patient would help the practitioner understand the resulting volume of PRP/RBCs that will used for injection or transfusion, and can help the practitioner modify the drawn blood to reach the resulting volume of PRP/RBC's needed. The total volume of blood may comprise 100 cc to 1000 cc; or 200 cc to 400 cc. For example, a patient having a 45% HCT and 200 cc of whole blood drawn yields 90 cc (0.45×200 cc) of PRP/RBC and 110 cc (200 cc minus 90 cc) of Plasma. Hematocrit may be acquired by standard procedures known in the art, including fingerstick, heelstick, venipuncture and/or any combination thereof.
In another embodiment, a method of calculating total whole blood volume to yield specific volume of PRP/RBCs prior to separation of blood into blood components comprises the steps of: acquiring hematocrit (HCT) from a patient (i.e., HCT measures the volume of packed red blood cells (RBC) relative to the whole blood); selecting a desired volume of PRP/RBC that will yield after centrifugation using the portable centrifuge; calculating total whole blood volume by dividing the desired volume of PRP/RBC by the HCT and calculating plasma volume by subtracting the calculated total whole blood volume minus the desired volume of PRP/RBC; drawing the calculated total whole blood volume; removing a protective cover from a portable centrifuge, the protective cover having an activation tab, the portable centrifuge comprising a rotational mechanism, an activation switch, and a timer; injecting the calculated total volume of whole blood through an injection tube disposed onto a container cover into a central container within the portable centrifuge; activating the portable centrifuge by replacing the protective cover over the container cover and the activation tab of the protective cover contacting the activation switch to trigger rotation of the rotation mechanism and the timer; separating the calculated whole blood volume into constituent components into a plurality of channels; removing the protective cover after the rotation ceases; and extracting the calculated blood constituent components through the container cover, calculated blood constituent components comprise the desired volume of PRP/RBCs and calculated plasma. Using HCT to calculate the whole blood to be drawn from a patient would help the practitioner understand the desired volume of PRP/RBCs that will used for injection or transfusion, and can help the practitioner modify the drawn blood volume to prevent waste or unnecessary multiple blood drawings to reach the desired volume of PRP/RBC's needed. The total volume of blood may comprise 100 cc to 1000 cc or 200 cc to 400 cc. For example, a patient having a 55% HCT and selecting a desired 90 cc of PRP/RBCs yields 164 cc (90 cc divided by 0.55) of total whole blood volume and 74 cc (164 cc minus 90 cc) of Plasma.
In another embodiment, a method of acquiring blood clotting time comprises the steps of: injecting whole blood through an injection tube disposed onto a container cover into a central container of the sequester wheel; disposing a protective cover over a portion of the sequester wheel to activate the rotation mechanism and the timer; separating the blood into constituent components into a plurality of channels and propelling a portion of the blood to enter a first blood communication port of a coagulation module; transporting blood through the at least one microchannel via centrifugal forces and/or a pressure differential to evaluate for clot time; removing the protective cover after the rotation ceases; analyzing clot time from the coagulation module; and extracting the blood constituent components from one or more extraction regions through the container cover.
In another embodiment, a method of acquiring blood clotting time comprises the steps of: injecting whole blood through an injection tube disposed onto a container cover into a central container of the sequester wheel; disposing a protective cover over a portion of the sequester wheel to activate the rotation mechanism and the timer; propelling a portion of the blood to enter a first blood communication port of a coagulation module; removing the protective cover after the rotation ceases; transporting blood through the at least one microchannel to evaluate for clot time using capillary action; and analyzing clot time from the coagulation module.
In another embodiment,
In another embodiment,
In another embodiment,
In another embodiment,
In another embodiment,
In another embodiment,
In another embodiment,
Blood is used in conjunction with the devices and methods described however, the devices and methods are applicable for use with bone marrow or other human and/or animal tissue, and/or any colloidal or suspension mixtures.
Claim 1. A centrifuge comprising: a base container having a rotational mechanism contained therein; a centrifuge container having a bottom plate and a top plate joined by a circumferential sidewall, and a coiled spring connected to the bottom plate; a sequester wheel comprising a plurality of concentric rings, forming at least one channel, connected to a hub; wherein the sequester wheel is engaged with the bottom plate, the coiled spring positioned therebetween, the hub centered with the bottom plate and the top plate within the centrifuge container, defining an axis; and wherein the centrifuge container is engaged with the rotational mechanism and rotatable about the axis.
Claim 2. The centrifuge of claim 1, further having a toggle switch pivotally engaged with the bottom plate and extending from a bottom side to a top side of the bottom plate and extending through the sequester wheel.
Claim 3. The centrifuge of claim 2, wherein the bottom plate is further comprising tabs for engaging the sequester wheel;
Claim 4. The centrifuge as in any of claims 1-3 wherein, the rotational mechanism comprises: a circuit having an internal power supply connected to a switch; wherein the switch is connected to an electrical motor and a solenoid.
Claim 5. The centrifuge of claim 4, wherein the circuit is further comprising a circuit board having a timer connected to a relay; and wherein the switch is connected to the electrical motor and the solenoid through the circuit board.
Claim 6. A centrifuge comprising: a base container having a rotational mechanism contained therein; a sequester device having a first center, a circumferential outer ring concentric with a plurality of inner tiered concentric rings forming at least one channel, and a container; a centrifuge cover having a top side with a second center and a circumferential sidewall; wherein the centrifuge cover is connected to the sequester device and forming a cylindrical container having an internal space with an outer channel; wherein the cylindrical container is coupled to the rotational mechanism and is rotatable about an axis defined by the first center and the second center.
Claim 7. The centrifuge of claim 6 wherein, the rotational mechanism comprises: a circuit having an internal power supply; wherein the power supply is connected to a switch and an electrical motor.
Claim 8. The centrifuge of claim 7, wherein the circuit further comprises a circuit board with a timer connected to a relay.
Claim 9. The centrifuge of claim 6, wherein the top side is conical.
Claim 10. The centrifuge of claim 6, further comprising: a protective cover having a top side with a first insertion hole around a third center and a circumferential sidewall extending to a sidewall rim; and an activation tab extending from the sidewall rim away from the top side; wherein the protective cover is engaged with the base container and the rotational mechanism, covering without contacting the centrifuge container.
Claim 11. The centrifuge of claim 10, wherein the top side of the centrifuge cover has a second insertion hole around the second center, extending through the centrifuge cover; and wherein the first insertion hole and the second insertion hole are aligned.
Claim 12. The centrifuge of claim 11, wherein the first insertion hole is covered by a membrane.
Claim 13. The centrifuge of claim 10, wherein the base container further comprises an activation slot through which the activation tab is insertable; and wherein the rotational mechanism further comprises an activation mechanism to which the activation tab is engaged.
Claim 14. The centrifuge of claim 13, wherein the activation slot comprises a locking protrusion; and wherein the locking protrusion provides for activation tab motion in a single direction.
Claim 15. The centrifuge container of claim 10, wherein the rotational mechanism comprises at least one light source; wherein the cylindrical container further comprises a transparent material; wherein the protective cover further comprises a transparent material; and wherein the light source is visible through the cylindrical container and the protective cover.
Claim 16. The centrifuge of claim 15, wherein the cylindrical container further comprises: a plurality of extraction holes through the top side into the cylindrical container and a visual marker on the top side adjacent to the extraction holes.
Claim 17. The centrifuge of claim 10, wherein the visual marker is visible through the protective cover.
Claim 18. A centrifuge comprising: a base container having a rotational mechanism contained therein; a cylindrical container having a top side with a first center, a bottom side with a second center, a sidewall, and an interior having an anti-coagulant and a thixotropic separation gel therein; wherein the cylindrical container is coupled to the rotational mechanism and is rotatable about an axis defined by the first center and the second center.
Claim 19. A centrifuge comprising: a base container having a rotational mechanism connected to an activation switch; a cap assembly having a cap at a first end of an articulated arm, an activation tab at a second end, and an activation handle protruding from the articulated arm; an activation armature; a conical first member positioned within a conical second member having a plurality of openings and positioned within a conical third member; and a base ring; wherein the first member engages the base ring and the base container, the activation armature extends from the base ring to the activation switch within the base container; wherein the second member engages the rotation mechanism above the first member and the third member is positioned above the second member to engage the first member, the second member being rotatable between the first member and the second member; and wherein the cap engages the third member, and the activation tab engages the activation armature, providing a connection between the activation handle and the activation switch for activation of the rotational mechanism.
Claim 20. A portable centrifuge comprising: a base, the base comprising a rotational mechanism and at least one light; a sequester device, the sequester device being disposed onto the base, the sequester device including a plurality of concentric rings that are spaced apart to form at least one channel; a container cover, the container cover including at least one injection tube and at least one extraction region, the at least one extraction region including a plurality of extraction holes, the container cover being disposed over the sequester device; and a protective cover, the protective being disposed over the container cover.
Claim 21. The portable centrifuge of claim 20, wherein the at least one light is a UV light.
Claim 22. The portable centrifuge of claim 21, wherein the UV light comprises emission of wavelengths within the UV-C wavelength for a germicidal effect.
Claim 23. The portable centrifuge of claim 22, wherein the UV-C wavelength comprises range of 200 to 300 nanometers.
Claim 24. The portable centrifuge of claim 20, wherein the sequester device comprises a coating, the coating is selected from a group consisting of anticoagulants, preservatives, germicidal agents, sterilants, antiseptics, clot activators, separator gels.
Claim 25. The portable centrifuge of claim 24, wherein the germicidal agents comprises amotosalen or riboflavin.
Claim 26. The portable centrifuge of claim 20, wherein the plurality of concentric rings spaced apart forming at least one channel comprises a coating, the coating is selected from a group consisting of anticoagulants, preservatives, disinfectants, germicidal agents, clot activators, separator gels, pathogen reduction agents or pathogen inactivation agents.
Claim 27. The portable centrifuge of claim 20, wherein the sequester device comprises a material, the material is a polymer.
Claim 28. The portable centrifuge of claim 26, wherein the polymer is clear or translucent.
Claim 29. The portable centrifuge of claim 20, wherein the plurality of extraction holes is aligned with the at least one channel.
Claim 30. A portable centrifuge comprising: a base, the base comprising a rotational mechanism, a first light and a second light; a sequester device, the sequester device being disposed onto the base, the sequester device including a plurality of concentric rings that are spaced apart to form at least one channel and a central container; a container cover, the container cover including at least one injection tube and at least one extraction region, the at least one extraction region including a plurality of extraction holes, the container cover being disposed over a portion of the sequester device; and a protective cover, the protective being disposed over the container cover.
Claim 31. The portable centrifuge of claim 30, wherein the container cover or the protective cover comprising a third light, the third light coupled to a portion of the container cover or the protective cover.
Claim 32. The portable centrifuge of claim 30, wherein the first light or second light comprises a UV light.
Claim 33. The portable centrifuge of claim 32, wherein the UV light comprises a wavelength emission within the UV-C wavelength range for a germicidal effect.
Claim 34. The portable centrifuge of claim 30, wherein at least a portion of the central container comprising a coating.
Claim 35. The portable centrifuge of claim 30, wherein at least a portion of the plurality of concentric rings comprising a coating.
Claim 36. The portable centrifuge of claim 30, wherein at least a portion of the plurality of concentric rings and at least a portion of the central container comprising a coating.
Claim 37. The portable centrifuge of claims 34, 35 and 36, the coating is selected from a group consisting of anticoagulants, preservatives, germicidal agents, sterilants, antiseptics, clot activators, separator gels.
Claim 38. The portable centrifuge of claim 37, wherein the germicidal agents comprises amotosalen or riboflavin.
Claim 39. The portable centrifuge of claim 30, wherein the first light or second light comprises a UV light, and at least a portion of the central container comprising a coating.
Claim 40. The portable centrifuge of claim 30, wherein the first light or second light comprises a UV light and at least a portion of the plurality of concentric rings comprising a coating.
Claim 41. The portable centrifuge of claim 30, wherein the first light or second light comprises a UV light, at least a portion of the central container comprising a coating and at least a portion of the plurality of rings comprising a coating.
Claim 42. The portable centrifuge of claims 39, 40 and 41, wherein the UV light comprises a wavelength emission within the UV-A wavelength range.
Claim 43. The portable centrifuge of claims 39, 40 and 41, wherein the coating comprises a germicidal agent, the germicidal agent is riboflavin or amotosalen.
Claim 44. The portable centrifuge of claim 31, wherein the third light comprises a UV light.
Claim 45. The portable centrifuge of claim 40, wherein the UV light comprises a wavelength emission within the UV-C wavelength range for a germicidal effect.
Claim 46. The portable centrifuge of claim 30, wherein the third light comprises a UV light, and at least a portion of the central container comprising a coating.
Claim 47. The portable centrifuge of claim 30, wherein the third light comprises a UV light and at least a portion of the plurality of concentric rings comprising a coating.
Claim 48. The portable centrifuge of claim 30, wherein the third light comprises a UV light, at least a portion of the central container comprising a coating and at least a portion of the plurality of rings comprising a coating.
Claim 49. The portable centrifuge of claims 46, 47 and 48, wherein the UV light comprises a wavelength emission within the UV-A wavelength range.
Claim 50. The portable centrifuge of claims 46, 47 and 48, wherein the coating comprises a germicidal agent, the germicidal agent is riboflavin or amotosalen.
Claim 51. The portable centrifuge of claim 30, wherein the first light or second light comprises a UV light, and the third light comprises a UV light.
Claim 52. The portable centrifuge of claim 51, wherein the UV light of the first or second light and the UV light of the third light is the same UV wavelength or different UV wavelengths.
Claim 53. The portable centrifuge of claim 51, wherein the UV light of the first or second light and the UV light of the third light comprises a wavelength emission within the UV-C wavelength range for a germicidal effect.
Claim 54. The portable centrifuge of claim wherein the first light or second light comprises a UV light, the third light comprises a UV light, and at least a portion of the central container comprising a coating.
Claim 55. The portable centrifuge of claim wherein the first light or second light comprises a UV light, the third light comprises a UV light, and at least a portion of the plurality of concentric rings comprising a coating.
Claim 56. The portable centrifuge of claim wherein the first light or second light comprises a UV light, the third light comprises a UV light, at least a portion of the plurality of concentric rings comprising a coating and at least a portion of the central container comprising a coating.
Claim 57. The portable centrifuge of claims 54, 55 and 56, wherein the UV light comprises a wavelength emission within the UV-A wavelength range.
Claim 58. The portable centrifuge of claims 54, 55 and 56, wherein the coating comprises a germicidal agent, the germicidal agent is riboflavin or amotosalen.
Claim 59. A method comprising: removing a protective cover from a centrifuge; introducing blood into a centrifuge container; replacing the protective cover of the centrifuge; turning the protective cover to activate the centrifuge; separating the blood into constituent components by rotation of the centrifuge; removing the protective cover from the centrifuge; and removing the blood constituent components.
Claim 60. A method comprising: removing a protective cover; introducing blood into a centrifuge container; replacing the protective cover; turning the protective cover to activate the centrifuge; having the blood interact with a thixotropic separation gel and an anti-coagulant; separating the blood into constituent components by activation of the centrifuge; removing the protective cover; and removing the blood constituent components.
Claim 61. A method comprising: removing a protective cover from a centrifuge; introducing blood into a centrifuge container; replacing the protective cover on the centrifuge; turning the protective cover to activate the centrifuge; separating the blood into constituent components; removing the protective cover; and removing the blood constituent components.
Claim 62. A method comprising: removing a cap assembly; introducing blood into test-tubes; replacing the cap assembly; pressing the activation handle to activate the centrifuge; separating the blood into constituent components by activation of the centrifuge; removing the cap assembly; and removing blood constituent components from the test-tubes.
Claim 63. A method of pathogen reduction during a centrifugation cycle comprising the steps of: Preparing a portable centrifuge for a centrifugation cycle, the portable centrifuge comprising at least one UV light, a rotational mechanism, a sequester device and a protective cover; injecting whole blood within at least a portion of the sequester device; activating the rotational mechanism and the at least one UV light by placing the protective cover over at portion of the sequester device; irradiating the whole blood with the at least one UV light while the portable centrifuge is separating the whole blood into constituent components into a plurality of channels within the sequester device; removing the protective cover; and extracting the blood constituent components from the sequester device.
Claim 64. A method of pathogen reduction during a centrifugation cycle comprising the steps of: Preparing a portable centrifuge for a centrifugation cycle, the portable centrifuge comprising at least one UV light, a rotational mechanism, a sequester device and a protective cover, at least a portion of the sequester device comprising a coating; injecting whole blood within at least a portion of the sequester device; activating the rotational mechanism and the at least one UV light by placing the protective cover over at portion of the sequester device; irradiating the whole blood with the at least one UV light while the portable centrifuge is separating the whole blood into constituent components into a plurality of channels within the sequester device; removing the protective cover; and extracting the blood constituent components from the sequester device.
Claim 65. A method of pathogen reduction during a centrifugation cycle of claim 63 or 64, the at least one UV light comprises a wavelength emission within the UV-C wavelength range for a germicidal effect.
Claim 66. A method of pathogen reduction during a centrifugation cycle of claim 64, the at least one UV light comprises a wavelength emission within the UV-A wavelength range for a germicidal effect.
Claim 67. A method of pathogen reduction during a centrifugation cycle of claim 64, the coating is selected from a group consisting of anticoagulants, preservatives, germicidal agents, sterilants, antiseptics, clot activators, separator gels.
Claim 68. The portable centrifuge of claim 67, wherein the germicidal agents comprises amotosalen or riboflavin.
Claim 69. A method of pathogen reduction during a centrifugation cycle of claim 64, the at least one UV light comprises a wavelength emission within the UV-A wavelength range for a germicidal effect and the coating comprises a germicidal agent, the germicidal agent is amotosalen or riboflavin.
Claim 70. A convalescent plasma therapy centrifuge comprising: a base, the base comprising a rotational mechanism, a first light and a second light; a sequester device, the sequester device being disposed onto the base, the sequester device including a first concentric ring and a second concentric that are spaced apart to form at least one channel and a central container; a container cover, the container cover including at least one injection tube and at least one extraction region, the at least one extraction region including a plurality of extraction holes, the container cover being disposed over a portion of the sequester device; and a protective cover, the protective being disposed over the container cover.
Claim 71. A microfluidic portable centrifuge comprising: a base, the base comprising a rotational mechanism; a sequester device, the sequester device being disposed onto the base, the sequester device including a plurality of concentric rings that are spaced apart to form at least one channel and a central container; a container cover, the container cover including at least one injection tube, at least one extraction region and at least one coagulation module, the at least one extraction region including a plurality of extraction holes, the at least one coagulation module comprising a top surface, a bottom surface, and a microfluidic mechanism, the microfluidic mechanism disposed between the top surface and the bottom surface, the bottom surface including a blood communication port, the container cover being disposed over a portion of the sequester device; and a protective cover, the protective being disposed over the container cover.
Claim 72. The microfluidic portable centrifuge of claim 71, wherein the microfluidic mechanism comprises at least one serpentine microchannel.
Claim 73. The microfluidic portable centrifuge of claim 71, wherein the microfluidic mechanism comprises a plurality of serpentine microchannels.
Claim 74. The microfluidic portable centrifuge of claim 71, wherein the microfluidic mechanism comprises at least one serpentine microchannel and a metering mechanism.
Claim 76. The microfluidic portable centrifuge of claim 71, wherein the microfluidic portable centrifuge further comprises a first light and a second light.
Claim 77. The microfluidic portable centrifuge of claim 75, wherein the first light or second light comprises a UV light.
Claim 78. The microfluidic portable centrifuge of claim 76, wherein the UV light comprises a wavelength emission within the UV-C wavelength range for a germicidal effect.
Claim 79. The microfluidic portable centrifuge of claim 72, wherein the at least one serpentine microchannel comprises a coating.
Claim 80. A portable centrifuge comprising: a base, the base comprising a rotational mechanism; a sequester device, the sequester device being disposed onto the base, the sequester device comprises a plurality of concentric rings that are spaced apart and tiered to form at least one channel and a central container; and a centrifuge cover, the centrifuge cover disposed over the sequester device to create a liquid impermeable seal.
Claim 81. The portable centrifuge of claim 80, wherein the portable centrifuge further comprises at least one light.
Claim 82. The portable centrifuge of claim 81, wherein the at least one light comprises a UV light.
Claim 83. The portable centrifuge of claim 80, wherein at least a portion of the sequester device comprises a coating.
Claim 84. The portable centrifuge of claim 80, wherein the portable centrifuge further comprises at least one UV light and at least a portion of the sequester device comprises a germicidal agent coating.
Claim 85. The portable centrifuge of claim 82, 83 or 84, wherein the UV light comprises a wavelength emission within the UV-C wavelength range for a germicidal effect.
Claim 86. The portable centrifuge of claim 83, the coating is selected from a group consisting of anticoagulants, preservatives, germicidal agents, sterilants, antiseptics, clot activators, separator gels.
Claim 87. The portable centrifuge of claim 84 or 86, wherein the germicidal agent comprises amotosalen or riboflavin.
Claim 88. The portable centrifuge of claim 80, wherein the central container comprises a first volume and the at least one channel comprises a second volume, the first volume is larger than the second volume.
Claim 89. The portable centrifuge of claim 80, wherein the central container comprises a first volume and the at least one channel comprises a second volume, the first volume and the second volume equals the total volume of extracted blood from a patient, the second volume substantially matches a portion of the total volume determined by multiplying hematocrit with the total volume of extracted blood.
Claim 90. The portable centrifuge of claim 80, wherein the at least one cover further comprises an injection port and at least one extraction region.
Claim 91. The portable centrifuge of claim 90, wherein the injection port is concentrically aligned with the central container, the at least one extraction region is adjacent to the insertion port, the at least one extraction region comprises at least one extraction hole, the at least one extraction hole aligns with the at least one channel.
Claim 92. The portable centrifuge of claim 80, wherein the at least one cover further comprises an opening, the opening is concentrically aligned with the central container, the opening is sized and configured to receive a filter or an eye dispensing mechanism.
Claim 93. The portable centrifuge of claim 80, wherein the portable centrifuge further comprises a protective cover, the protective cover is disposed over the centrifuge cover and rotatable from an unlocked position, which the rotational mechanism is not engaged to a locked position that engages the rotational mechanism to initiate rotation.
Claim 94. A portable centrifuge for plasma therapy comprising: a base, the base comprising a rotational mechanism; a sequester device, the sequester device being disposed onto the base, the sequester device including a first concentric ring and a second concentric ring that are spaced apart and tiered to form at least one channel and a central container; and a centrifuge cover, the centrifuge cover including an injection port and at least one extraction region, the at least one extraction region including at least one extraction hole, the container cover being disposed over a portion of the sequester device to create a liquid impermeable seal.
Claim 95. The portable centrifuge of claim 94, wherein at least a portion of the portable centrifuge is sterilized.
Claim 96. The portable centrifuge of claim 94, wherein the portable centrifuge further comprises at least one light.
Claim 97. The portable centrifuge of claim 96, wherein the at least one light comprises a UV light.
Claim 98. The portable centrifuge of claim 94, wherein at least a portion of the sequester device comprises a coating.
Claim 99. The portable centrifuge of claim 94, wherein the portable centrifuge further comprises at least one UV light and at least a portion of the sequester device comprises a germicidal agent coating.
Claim 100. The portable centrifuge of claim 97 or 99, wherein the UV light comprises a wavelength emission within the UV-C wavelength range for a germicidal effect.
Claim 101. The portable centrifuge of claim 98, the coating is selected from a group consisting of anticoagulants, preservatives, germicidal agents, sterilants, antiseptics, clot activators, separator gels.
Claim 102. The portable centrifuge of claim 94, wherein the central container comprises a first volume and the at least one channel comprises a second volume, the first volume is larger than the second volume.
Claim 103. The portable centrifuge of claim 94, wherein the central container comprises a first volume and the at least one channel comprises a second volume, the first volume and the second volume equals the total volume of extracted blood from a patient, the second volume substantially matches a portion of the total volume determined by multiplying hematocrit with the total volume of extracted blood.
Claim 104. The portable centrifuge of claim 94, wherein the injection port is concentrically aligned with the central container and the at least one extraction hole aligns with the at least one channel.
Claim 105. The portable centrifuge of claim 94, wherein the portable centrifuge further comprises a protective cover, the protective cover is disposed over the centrifuge cover and rotatable from an unlocked position, which the rotational mechanism is not engaged to a locked position that engages the rotational mechanism to initiate rotation.
Claim 106. A portable centrifuge for ocular disorder therapy comprising: a base, the base comprising a rotational mechanism; a sequester device, the sequester device being disposed onto the base, the sequester device comprises at least one concentric ring that forms a central container and a channel; and a centrifuge cover, the centrifuge cover including an opening that concentrically aligns with the central container of the sequester device, the centrifuge cover disposed over the sequester device to create a liquid impermeable seal.
Claim 107. The portable centrifuge of claim 106, wherein the portable centrifuge further comprises at least one light.
Claim 108. The portable centrifuge of claim 107, wherein the at least one light comprises a UV light.
Claim 109. The portable centrifuge of claim 106, wherein at least a portion of the sequester device comprises a coating.
Claim 110. The portable centrifuge of claim 106, wherein the portable centrifuge further comprises at least one UV light and at least a portion of the sequester device comprises a germicidal agent coating.
Claim 111. The portable centrifuge of claim 108 or 110, wherein the UV light comprises a wavelength emission within the UV-C wavelength range for a germicidal effect.
Claim 112. The portable centrifuge of claim 109, the coating is selected from a group consisting of anticoagulants, preservatives, germicidal agents, sterilants, antiseptics, clot activators, separator gels.
Claim 113. The portable centrifuge of claim 110 or 112, wherein the germicidal agent comprises amotosalen or riboflavin.
Claim 114. The portable centrifuge of claim 106, wherein the central container comprises a first volume and the channel comprises a second volume, the first volume is larger than the second volume.
Claim 115. The portable centrifuge of claim 106, wherein the central container comprises a first volume and the at least one channel comprises a second volume, the first volume and the second volume equals the total volume of extracted blood from a patient, the second volume substantially matches a portion of the total volume determined by multiplying hematocrit with the total volume of extracted blood.
Claim 116. The portable centrifuge of claim 106, wherein the central container and the opening is sized and configured to receive a filter or an eye dispensing mechanism.
Claim 117. The portable centrifuge of claim 106, wherein the portable centrifuge further comprises a protective cover, the protective cover is disposed over the centrifuge cover and rotatable from an unlocked position, which the rotational mechanism is not engaged to a locked position that engages the rotational mechanism to initiate rotation.
Claim 118. The portable centrifuge for isolation of MNC's from peripheral blood comprises: a base, the base comprising a rotational mechanism; a sequester device, the sequester device being disposed onto the base, the sequester device comprises at least one channel, a first cylinder having a first inner diameter and a first outer diameter, and a second cylinder having a second inner diameter, the first inner diameter forms a central container, the first cylinder is disposed within the second inner diameter of the second cylinder, the first cylinder is concentric and tiered to the second cylinder, the at least one channel positioned between the first outer diameter of the first cylinder and the second inner diameter of the second cylinder; a centrifuge cover, the centrifuge cover including a port extending from a top surface of the centrifuge cover, the centrifuge cover disposed over the sequester device to create a liquid impermeable seal; and one or more reagents; the one or more reagents is disposed within the sequester device.
Claim 119. The portable centrifuge for isolation of MNC's from peripheral blood comprises: a base, the base comprising a rotational mechanism; a sequester device, the sequester device being disposed onto the base, the sequester device comprises at least one channel, a first ring including an inner diameter that forms a central container, a second ring, the first ring is disposed within the second ring, the first ring is separated from the second ring by the at least one channel, the second ring is concentric and tiered from the first ring; a centrifuge cover, the centrifuge cover including a luer port the centrifuge cover disposed over a portion of the sequester device to create a liquid impermeable seal; and one or more reagents; the one or more reagents is disposed within the sequester device.
Claim 120. The portable centrifuge of claim 118 or 119, wherein the portable centrifuge further comprises a protective cover, the protective cover is disposed over the centrifuge cover.
Claim 121. The portable centrifuge of claim 118 or 119, wherein the one or more reagents comprises a density gradient media.
Claim 122. The portable centrifuge of claim 118 or 119, wherein the one or more reagents comprises a density gradient media and an anticoagulant.
Claim 123. The portable centrifuge of claim 121 or 122, wherein density gradient media is disposed within the sequester device comprises being disposed into at least one channel of the sequester device.
Claim 124. The portable centrifuge of claim 118 or 119, wherein the portable centrifuge further comprises at least one light.
Claim 125. The portable centrifuge of claim 124, wherein the at least one light comprises a UV light.
Claim 126. The portable centrifuge of claim 118 or 119, wherein at least a portion of the sequester device comprises a coating.
Claim 127. The portable centrifuge of claim 125, wherein the UV light comprises a wavelength emission within the UV-C wavelength range for a germicidal effect.
Claim 128. The portable centrifuge of claim 126, wherein the coating is selected from a group consisting of anticoagulants, preservatives, germicidal agents, sterilants, antiseptics, clot activators, separator gels.
Claim 129. The portable centrifuge of claim 118 or 119, wherein the luer port is centrally located on a top surface of the centrifuge cover.
Claim 130. The portable centrifuge of claim 118 or 119, wherein the centrifuge cover further comprises a at least one extraction region, the at least one extraction region includes at least one extraction hole.
Claim 131. The portable centrifuge of claim 130, wherein the centrifuge cover further comprises a second extraction region, the second extraction region comprises at least one extraction hole, the second extraction region is diametrically opposite to the at least one extraction region or spaced 180 degrees apart.
Claim 132. The portable centrifuge of claim 130 or 131, wherein the at least one extraction hole aligns with the at least one channel.
Claim 133. The portable centrifuge for isolation of MNC's from bone marrow comprises: a base, the base comprising a rotational mechanism; a sequester device, the sequester device being disposed onto the base, the sequester device comprises a first channel, a second channel, a first cylinder, a second cylinder and a third cylinder, the first cylinder having a first inner diameter and a first outer diameter, the first inner diameter forms a central container, the second cylinder having a second inner diameter and second outer diameter, and the third cylinder having a third inner diameter and third outer diameter, the second cylinder is disposed within the third inner diameter of the third cylinder, the second channel is positioned between the third inner diameter of the third cylinder and the second outer diameter of the second cylinder, the first cylinder is disposed within the second inner diameter of the second cylinder, the first channel is positioned between the second inner diameter of the second cylinder and the first outer diameter of the first cylinder, the first, second and third cylinder are concentric to each other and tiered; a centrifuge cover, the centrifuge cover including a luer port and at least one opening, the centrifuge cover disposed over the sequester device to create a liquid impermeable seal; and one or more blister modules, the one or more blister modules removably connected to the to the centrifuge cover, the one or more blister modules comprise a frangible base and a chamber, the chamber includes at least one reagent, the chamber is movable from a first position that is uncompressed and filled with the at least one reagent to a second position, which the chamber is compressed to break the frangible base allowing the at least one reagent to be in fluid communication with the at least one opening and dispense the at least one reagent into the sequester device.
Claim 134. The portable centrifuge for isolation of MNC's from bone marrow comprises: a base, the base comprising a rotational mechanism; a sequester device, the sequester device being disposed onto the base, the sequester device comprises a first channel, a second channel, a first ring, a second ring, and a third ring, the second ring is disposed within the third ring and separated by the second channel, the first ring is disposed within the second ring and separated by the first channel, the first ring including an inner diameter that forms a central container, the first, second and third ring are concentric and tiered; a centrifuge cover, the centrifuge cover including a luer port and at least one opening, the centrifuge cover disposed over a portion of the sequester device to create a liquid impermeable seal; and one or more blister modules, the one or more blister modules removably connected to the to the centrifuge cover, the one or more blister modules comprise a frangible base and a chamber, the chamber includes at least one reagent, the chamber is movable from a first position that is uncompressed and filled with the at least one reagent to a second position, which the chamber is compressed to break the frangible base allowing the at least one reagent to be in fluid communication with the at least one opening of the centrifuge cover and dispense the at least one reagent into the sequester device.
Claim 135. The portable centrifuge of claim 133 or 134, wherein the portable centrifuge further comprises a protective cover, the protective cover is disposed over the centrifuge cover.
Claim 136. The portable centrifuge of claim 133 or 134, wherein each of the one or more blister modules are adjacent to the luer port and positioned diametrically opposite and/or spaced 180 degrees apart.
Claim 137. The portable centrifuge of claim 133 or 134, wherein the at least one reagent comprises at least one of a density gradient media, anticoagulant, thixotropic gel, buffer, dilution media, and/or any combination thereof.
Claim 138. The portable centrifuge of claim 133 or 134, wherein the at least one reagent is dispensed into the sequester device comprises dispensing into the central container of the first ring of the sequester device.
Claim 139. The portable centrifuge of claim 133 or 134, wherein the portable centrifuge further comprises at least one light.
Claim 140. The portable centrifuge of claim 139, wherein the at least one light comprises a UV light.
Claim 141. The portable centrifuge of claim 133 or 134, wherein at least a portion of the sequester device comprises a coating.
Claim 142. The portable centrifuge of claim 140, wherein the UV light comprises a wavelength emission within the UV-C wavelength range for a germicidal effect.
Claim 143. The portable centrifuge of claim 141, wherein the coating is selected from a group consisting of anticoagulants, preservatives, germicidal agents, sterilants, antiseptics, clot activators, separator gels.
Claim 144. The portable centrifuge of claim 133 or 134, wherein the luer port is centrally located on the top surface of the centrifuge cover.
Claim 145. The portable centrifuge of claim 133 or 134, wherein the centrifuge cover further comprises at least one extraction region, the at least one extraction region includes at least one extraction hole.
Claim 146. The portable centrifuge of claim 145, wherein the centrifuge cover further comprises a second extraction region, the second extraction region comprises at least one extraction hole, the second extraction region is diametrically opposite to the at least one extraction region or spaced 180 degrees apart.
Claim 147. The portable centrifuge of claim 145 or 146, wherein the at least one extraction hole aligns with the at least one channel.
Claim 148. The portable centrifuge for isolation of SVF from adipose tissue comprises: a base, the base comprising a rotational mechanism; a sequester device, the sequester device being disposed onto the base, the sequester device comprises a first channel, a second channel, a first ring, a second ring, and a third ring, the second ring is disposed within the third ring and separated by the second channel, the first ring is disposed within the second ring and separated by the first channel, the first ring including an inner diameter that forms a central container, the first, second and third ring are concentric and tiered; a centrifuge cover, the centrifuge cover including a luer port, the centrifuge cover disposed over a portion of the sequester device to create a liquid impermeable seal; and a disaggregation mechanism, the disaggregation mechanism includes a central member, the central member comprises a plurality of facets extending away from an external surface, each of the plurality of facets having a portion of sharp edges.
Claim 149. The portable centrifuge of claim 148, wherein the disaggregation mechanism is stationary relative to the sequester device while the rotation mechanism is activated.
Claim 150. The portable centrifuge of claim 148, wherein the portable centrifuge further comprises an incubator.
Claim 151. The portable centrifuge of claim 148, wherein the portable centrifuge further comprises a one or more blister modules, the one or more blister modules removably connected to the to the centrifuge cover, the one or more blister modules comprise a frangible base and a chamber, the chamber includes at least one reagent, the chamber is movable from a first position that is uncompressed and filled with the at least one reagent to a second position, which the chamber is compressed to break the frangible base allowing the at least one reagent to be in fluid communication with an at least one opening disposed on the centrifuge cover and dispense the at least one reagent into the sequester device.
Claim 152. The portable centrifuge of claim 148, wherein the portable centrifuge further comprises an agitation mechanism.
Claim 153. The portable centrifuge of claim 148, wherein the portable centrifuge further comprises an incubator and an agitation mechanism.
Claim 154. The portable centrifuge of claim 148, wherein the portable centrifuge further comprises an incubator, an agitation mechanism, and one or more blister modules.
Claim 155. The portable centrifuge of claim 150, 153, or 154, wherein the incubator comprises a chemical or electrical incubator.
Claim 156. The portable centrifuge of claim 152, 153 or 154, wherein the agitation mechanism comprises an oscillation or shaking action.
Claim 157. The portable centrifuge of claim 154, wherein the one or more blister modules removably connected to the to the centrifuge cover, the one or more blister modules comprise a frangible base and a chamber, the chamber includes at least one reagent, the chamber is movable from a first position that is uncompressed and filled with the at least one reagent to a second position, which the chamber is compressed to break the frangible base allowing the at least one reagent to be in fluid communication with an at least one opening disposed on the centrifuge cover and dispense the at least one reagent into the sequester device.
Claim 158. The portable centrifuge of claim 148, wherein the portable centrifuge further comprises a protective cover, the protective cover is disposed over the centrifuge cover.
Claim 159. The portable centrifuge of claim 151 or 157, wherein each of the one or more blister modules are adjacent to the luer port and positioned diametrically opposite and/or spaced 180 degrees apart.
Claim 160. The portable centrifuge of claim 151 or 157, wherein the at least one reagent comprises at least one of a density gradient media, anticoagulant, thixotropic gel, buffer, dilution media, and/or any combination thereof.
Claim 161. The portable centrifuge of claim 151 or 157, wherein the at least one reagent is dispensed into the sequester device comprises dispensing into the central container of the first ring of the sequester device.
Claim 162. The portable centrifuge of claim 148, wherein the portable centrifuge further comprises at least one light.
Claim 163. The portable centrifuge of claim 162, wherein the at least one light comprises a UV light.
Claim 164. The portable centrifuge of claim 148, wherein at least a portion of the sequester device comprises a coating.
Claim 165. The portable centrifuge of claim 163, wherein the UV light comprises a wavelength emission within the UV-C wavelength range for a germicidal effect.
Claim 166. The portable centrifuge of claim 164, wherein the coating is selected from a group consisting of anticoagulants, preservatives, germicidal agents, sterilants, antiseptics, clot activators, separator gels.
Claim 167. The portable centrifuge of claim 148, wherein the luer port is centrally located on the top surface of the centrifuge cover.
Claim 168. The portable centrifuge of claim 148, wherein the centrifuge cover further comprises a at least one extraction region, the at least one extraction region includes at least one extraction hole.
Claim 169. The portable centrifuge of claim 168, wherein the centrifuge cover further comprises a second extraction region, the second extraction region comprises at least one extraction hole, the second extraction region is diametrically opposite to the at least one extraction region or spaced 180 degrees apart.
Claim 170. The portable centrifuge of claim 168 or 169, wherein the at least one extraction hole aligns with the at least one channel.
Claim 171. The portable centrifuge of claim 148, wherein at least one of the first ring, second ring and third ring comprise a filtration cylinder, the filtration cylinder including a mesh size, the mesh size is at least 70 micrometers.
Claim 172. The portable centrifuge of claim 134 or 148, wherein at least the first cylinder/ring or second cylinder/ring comprises a filtration cylinder/ring, the filtration cylinder/ring including a mesh size, the mesh size is at least 70 micrometers.
This application is a continuation of PCT Appl. No. PCT/US22/15937, entitled “Portable Centrifuge Apparatus & Methods,” filed on Feb. 10, 2022, which claims benefit to Prov. Appl. No. 63/147,908, filed on Feb. 10, 2021 entitled “Microfluidic Centrifuge Device and Method of Use”, and Prov. Appl. No. 63/237,039, filed on Aug. 25, 2021, entitled “Isolation of Stem Cells Using Portable Centrifuge,” which are incorporated herein by reference in their entireties. This application is a continuation-in-part of U.S. application Ser. No. 17/695,650, entitled “Centrifuge Device and Method of Use,” filed on Mar. 15, 2022, which is a continuation application of PCT Appl. No. PCT/US2020/050014, filed Sep. 9, 2020, entitled “Centrifuge Device and Method of Use,” which claims priority to U.S. patent application Ser. No. 16/815,430, filed on Mar. 11, 2020, entitled “Centrifuge and Method of Use,” and claims benefit to Prov. Appl. No. 62/904,896, filed on Sep. 24, 2019, entitled “Centrifuge Device and Method of Use”, and Prov. Appl. No. 63/026,624, filed on May 18, 2020, entitled “Centrifuge Device and Method of Use,” which are all incorporated herein by reference in their entireties. This application is a continuation-in-part of U.S. patent application Ser. No. 16/815,430, filed on Mar. 11, 2020, entitled “Centrifuge and Method of Use,” which claims benefit to Prov. Appl. No. 62/816,873, filed on Mar. 11, 2019, entitled “PRP Centrifuge and Method of Use, which are all incorporated herein by reference in their entireties.
Number | Date | Country | |
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63237039 | Aug 2021 | US | |
63147908 | Feb 2021 | US | |
63026624 | May 2020 | US | |
62904896 | Sep 2019 | US | |
62816873 | Mar 2019 | US |
Number | Date | Country | |
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Parent | PCT/US20/50014 | Sep 2020 | US |
Child | 17695650 | US | |
Parent | PCT/US22/15937 | Feb 2022 | US |
Child | 16815430 | US |
Number | Date | Country | |
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Parent | 17695650 | Mar 2022 | US |
Child | 18231941 | US | |
Parent | 16815430 | Mar 2020 | US |
Child | PCT/US20/50014 | US | |
Parent | 16815430 | Mar 2020 | US |
Child | 16815430 | US |