Design of extracorporeal circuits and columns for extracorporeal circuits

Abstract

Systems and methods for processing bodily fluids using a cartridge that can include, for example, a cartridge body configured to hold an adsorbent material and an end segment configured to cover a first end of the cartridge body. The end segment can include a circular surface having an outwardly truncated conical shape defining an interior conical space, a cylindrical wall joined to the periphery of the circular surface, and an inlet configured to provide communication with a source of bodily fluid. The inlet can be positioned tangentially in the cylindrical wall relative to the circular surface to direct bodily fluid entering the cartridge tangentially into the interior conical space to decelerate the bodily fluid in the interior conical space before contacting the adsorbent material disposed within the cartridge body.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 587,090, entitled “Extracorporeal Circuit and Column Design Therefore,” filed November 16, 2017 by Todd Goodrich et al., which is incorporated herein by reference as if reprinted in its entirety. [Background technology]

[0002] A body fluid is a liquid originating from within a living human body. Body fluids include both fluids present within the body as well as fluids excreted or secreted from the body. Body fluids act as reservoirs of molecules that function as disease vectors or disease-related toxins during pathophysiological events or in autoimmune disease situations. Attenuating activity with respect to such molecules, thus suppressing the resulting adverse events associated with levels of these molecules that are detrimental to the physiological well-being of a subject, has the potential to continue to develop into numerous therapeutic options.

[0003] Thus, there is a continuing need for systems, devices and methods for selectively removing such molecules from bodily fluids. Summary of the Invention

[0004] In one aspect, a cartridge for treatment of bodily fluids can comprise a cartridge body configured to hold an adsorbent material and an end segment configured to cover a first end of the cartridge body, the end segment having an outwardly truncated conical shape, a circular surface defining an interior conical space, a cylindrical wall joined to the periphery of the circular surface, and an inlet configured to provide communication with a source of bodily fluid, the inlet being positioned tangentially to the circular surface in the cylindrical wall to direct bodily fluid entering the cartridge tangentially into the interior conical space to decelerate the bodily fluid in the interior conical space prior to contacting the adsorbent material disposed within the cartridge body.

[0005] In one aspect, a method of removing one or more components present in a bodily fluid to produce a purified bodily fluid can include attaching a cartridge to an input of the bodily fluid, attaching the cartridge to an output of the purified bodily fluid from the cartridge, and passing the bodily fluid through the cartridge, the cartridge comprising a cartridge body configured to hold an adsorbent material and an end segment configured to cover a first end of the cartridge body, the end segment comprising an outwardly truncated conical shape and a circular surface defining an interior conical space, a cylindrical wall joined to a periphery of the circular surface, and an inlet configured to provide communication to a source of bodily fluid, the inlet being disposed tangentially in the cylindrical wall to direct the bodily fluid entering the cartridge tangentially into the interior conical space to decelerate the bodily fluid in the interior conical space prior to contacting the adsorbent material disposed within the cartridge body, and the method can further include filtering one or more substances from the bodily fluid to produce a purified bodily fluid.

[0006] In one aspect, a cartridge can include a cartridge body and an end segment configured to cover a first end of the cartridge body, the end segment having an outwardly truncated conical shape, a circular surface defining an interior conical space, a cylindrical wall joined to the periphery of the circular surface, and an inlet configured to provide communication with a source of bodily fluid, the inlet being disposed tangentially in the cylindrical wall to the circular surface to direct bodily fluid entering the cartridge tangentially into the interior conical space to decelerate the bodily fluid in the interior conical space prior to contacting an adsorbent material disposed within the cartridge body, and the cartridge can further include an adsorbent material retained within the cartridge body by at least one end segment.

[0007] For a more complete understanding of the present disclosure, reference is now made to the following brief description taken in conjunction with the accompanying drawings and detailed description, where like reference numerals represent like parts. [Brief description of the drawings]

[0008] [Figure 1] 1 illustrates a system including a cartridge for removing one or more components present in a bodily fluid to produce a purified bodily fluid according to one embodiment of the present disclosure. [Diagram 2] FIG. 1 illustrates a front view of a cartridge according to one aspect of the present disclosure. [Diagram 3] FIG. 1 illustrates a side view of a cartridge according to one aspect of the present disclosure. [Figure 4] 1 illustrates an exploded view of a cartridge according to one aspect of the present disclosure. [Diagram 5] 1 shows a cross-sectional view of a cartridge according to one aspect of the present disclosure. [Figure 6] 1 illustrates another cross-sectional view of a cartridge according to an aspect of the present disclosure. [Figure 7] 1 shows a perspective view of an end segment of a cartridge according to one aspect of the present disclosure. [Figure 8] 1 illustrates a side view of an end segment of a cartridge according to one aspect of the present disclosure. [Figure 9] FIG. 1 illustrates a top view of an end segment of a cartridge according to one aspect of the present disclosure. [Figure 10] 1 illustrates a cross-sectional view of an end segment of a cartridge according to one aspect of the present disclosure. [Figure 11] 13 illustrates another side view of an end segment of a cartridge according to one aspect of the present disclosure. [Figure 12] 13 illustrates another cross-sectional view of an end segment of a cartridge according to one aspect of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] Aspects of the present disclosure include systems, devices, and methods for contacting a subject's bodily fluid with a device configured to remove one or more components, such as toxins or other small molecules, present in the bodily fluid to generate a purified bodily fluid, and returning at least a portion of the purified bodily fluid to the subject. In some embodiments, the bodily fluid may be blood or a blood component, such as whole blood, red blood cells (i.e., erythrocytes), white blood cells (i.e., leukocytes), or a combination thereof. In one or more of the following embodiments, the systems, devices, and methods may be disclosed with respect to the processing of blood or blood components, but the systems, devices, and methods disclosed herein may be applicable to other bodily fluids in other embodiments as well. For example, in addition to or instead of blood or blood components, in various embodiments, the bodily fluid may include lymphatic fluid, cerebrospinal fluid, bile, peritoneal fluid, serous fluid, or a combination thereof.

[0010] One embodiment of a system suitable for removing one or more components from a bodily fluid is shown in FIG. 1. In the embodiment of FIG. 1, the system 100 comprises an inlet 102 that may be configured to receive blood flow from a subject (e.g., a patient). For example, the inlet 102 may be configured to access an artery of the subject to provide blood flow from the subject through the inlet 102. In various embodiments, access to the blood flow may be obtained through the subject's jugular, subclavian, or femoral vein, for example, by a two-lumen catheter, although other options for establishing blood flow from the subject include, for example, but are not limited to, existing vascular access, such as vascular access used in hemodialysis created by an initial surgical procedure, for example, a native arteriovenous fistula (native AVF), an arteriovenous shunt using graft material (AV graft), and a tunneled two-lumen catheter. As a safety measure, in some embodiments, the inlet 102 may include multiple electrodes (e.g., 2-4 electrodes) configured to sense and signal separation of the inlet 102. Another embodiment for detecting accidental separation is to use a conductive blanket below the inlet 102. In such an embodiment, the presence of blood changes the conductivity of the blanket, generating an alarm.

[0011] The inlet 102 may be in communication with the pump 155 via a conduit 190. The conduit 190 may include a sampling infusion port 104 that may be configured to regulate access and communication via the conduit 190. The pump 155 may regulate communication of the subject's blood to the remainder of the system 100. The conduit 190 may include any suitable type or configuration and may be constructed of materials suitable for use in the methods disclosed herein. The conduit 190 is fluidly connected to the pump 155 via a pump inlet port 106. Pressure at the pump inlet port 106 may be detected by an arterial pressure sensor 159 that may be selectively activated using a pinch clamp 157.

[0012] In some embodiments, blood exiting the pump 155 through the pump outlet port can be contacted with an effective amount of an anticoagulant, such as heparin, through a flow path connected to a source of the anticoagulant, shown as a heparin source 130, which can be selectively controlled by a pinch clamp 161. The heparinized blood can then be conveyed through the outlet port 108 to a level detector 110 that communicates a signal with the cartridge pressure sensor 140, and then enter the cartridge 112 through the first end segment 175. The cartridge 112 can contain a therapeutic compound that includes carbon for treatment (e.g., removal of components such as contaminants or toxins). The blood that has been contacted with the therapeutic compound present in the cartridge 112 then exits the cartridge in a specific flow direction 172. The blood exiting the cartridge 112 through an outlet regulated by the valve 114 can enter a conduit 195 that includes a venous return port 198. Conduit 195 is fluidly connected to a level detector 118 which communicates signals with a venous pressure detector 150 which can be selectively activated using a pinch clamp 163. An air detector 120 (along with a pinch clamp 122 and a transducer protector 126) can be placed in line with conduit 195, which can allow blood to flow back to the subject via return 124 and any suitable route, such as, but not limited to, the jugular, subclavian, or femoral veins, or other vascular system.

[0013] In various embodiments, system 100 can be generally configured such that the flow rate of bodily fluid (e.g., plasma, whole blood) through system 100 can be adjusted to effect some user and / or process goal. For example, the flow rate of blood through system 100 can range from about 1 mL / min to about 500 mL / min, or from about 25 mL / min to about 300 mL / min, or can be about 25 mL / min.

[0014] In some embodiments, the cartridge 112 can be configured to provide sufficient contact between the bodily fluid (e.g., blood) to be treated and suitable treatment materials contained in the cartridge. For example, with reference to Figures 2 and 3, one embodiment of a cartridge 200 suitable for use in the context of Figure 1 and in the methods disclosed herein is shown. In particular, Figure 2 shows a front view of the cartridge 200, and Figure 3 shows a side view of the cartridge 200.

[0015] 2 and 3, cartridge 200 comprises a first end segment 220, a second end segment 225, and a cartridge body 230. In various embodiments, one or more components forming cartridge 200, such as one or more of first end segment 220, second end segment 225, or cartridge body 230, can be any suitable material, for example, compatible with the process and composition in which cartridge 200 is intended to be used. Examples of such materials can include, but are not limited to, polycarbonates, such as high temperature polycarbonates, polysulfones, polyetherimides, autoclavable polypropylenes, polyethersulfones, and combinations thereof.

[0016] In some embodiments, the configurations of cartridge 200 disclosed herein, and more particularly the configurations of first end segment 220 disclosed herein, allow bodily fluids, such as blood, to enter cartridge body 230 in a manner such that the chaotic, turbulent nature of the bodily fluid flow is reduced before the bodily fluid interacts with processing materials disposed within cartridge body 230. In some embodiments, this reduction in chaotic, turbulent flow prior to interaction with processing materials (within cartridge body 230) can be effective to reduce deleterious effects associated with subjecting whole blood or plasma to a chromatographic cartridge, as disclosed herein.

[0017] In some embodiments, the cartridge body 230 generally comprises a hollow cylindrical structure. In various embodiments, the cartridge body 230 may comprise a single integral structure or may comprise two or more operably coupled components. The cartridge body 230 generally can define an interior space in which, for example, a processing material can be disposed, as disclosed herein. In some embodiments, the first end segment 220 and the second end segment 225 can substantially surround the cartridge body 230, for example, to form a substantially enclosed interior space. In some embodiments, the first end segment 220 and / or the second end segment 225 can comprise components that are separate from the cartridge body and configured to engage with the cartridge body 230. For example, in some embodiments, the first end segment 220 (e.g., a first cap or cover) and / or the second end segment 225 (e.g., a second cap or cover) can be configured to engage the cartridge body 230 via a threaded interface to secure the first end segment 220 and / or the second end segment 225 to the cartridge body 230. Additionally or alternatively, in some embodiments, the components of the cartridge 200 can be attached to one another by a suitable adhesive. For example, additionally or alternatively, the first end segment 220 and / or the second end segment 225 can be attached to the cartridge body 230 via one or more layers of adhesive. In other embodiments, two or more components of the cartridge 200 can be integral with one another. For example, in some embodiments, the first end segment 220 and / or the second end segment 225 can be integral with the cartridge body 230 (e.g., formed as part of the cartridge body 230).

[0018] In some embodiments, the cartridge 200 can include one or more screen assemblies, such as, for example, a first screen assembly 210, which can be disposed between the first end segment 220 and the cartridge body 230, and / or a second screen assembly 212, which can be disposed between the second end segment 225 and the cartridge body 230.

[0019] In some embodiments, the first end segment 220 comprises a first inlet 222 disposed therein and generally configured to direct the flow of bodily fluid into the cartridge 200, and in particular into the first end segment 220. In some embodiments, as disclosed herein, the first inlet 222 can be configured to direct the flow of fluid into the first end segment 220 in a direction generally tangential to the first end segment. In some embodiments, the first inlet 222 can be configured to engage a luer fitting 260, which may be configured to receive a luer plug 240, for example, to be fluidly connected to a conduit (e.g., conduit 190 in the context of FIG. 1).

[0020] In some embodiments, the first end segment 220 can further comprise a second inlet 223. The second inlet 223 can generally be configured to direct fluid into the first end segment 220 in a direction generally parallel to the longitudinal axis of the cartridge 200 (e.g., at the center of the first end segment 220). In some embodiments, the second inlet 223 can be configured to receive a luer fitting, such as a luer cap 280. In various embodiments, the second inlet 223 can provide an additional path for fluid flow into the first end segment 220 (e.g., to provide a therapeutic compound or a second bodily fluid), a path for fluid flow out of the first end segment 220 (e.g., to recirculate a portion of the fluid flow), or a port for monitoring or relieving pressure within the cartridge 200.

[0021] In some embodiments, the second end segment can include an outlet 226. The outlet 226 can be generally configured to direct fluid out of the cartridge 200. In some embodiments, the outlet 226 can be configured to engage a Luer return fitting 250, which can be configured to receive a Luer plug 270, for example, to be fluidly connected to a conduit (e.g., conduit 195 in the context of FIG. 1).

[0022] In some embodiments, the cartridge body 230 can further comprise a plug 290, for example, to allow access to the interior of the cartridge body 230.

[0023] 4, an exploded view of the cartridge 200 is shown. In some embodiments, the components of the cartridge 200 can be engaged with one another by any suitable interface, such as, for example, a threaded connection, a compression interface, an adhesive, etc. For example, the screen assembly 210 can be held in place between the first end segment 220 and the cartridge body 230 by attachment of the first end segment 220 to the cartridge body 230 or one or more layers of adhesive. Similarly, the screen assembly 212 can be held in place between the second end segment 225 and the cartridge body 230 by attachment of the second end segment 225 to the cartridge body 230 or one or more layers of adhesive.

[0024] Referring to Figure 5, a cross-sectional view of cartridge 200 is shown. The flat cross-section of Figure 5 is a cross-section in a plane extending through the center of first inlet 222 of first end segment 220 (as well as luer plug 240 and luer fitting 260). In some embodiments, as shown in Figure 5, cartridge 200 can further include a treatment material, such as, for example, a sorbent material 235 retained within cartridge body 230 by one or more screen assemblies 210 and 212.

[0025] In some embodiments, the adsorbent material comprises synthetic carbon particles (SCPs), such as activated carbon (e.g., activated carbon beads, and / or medical grade carbon), containing micropores, mesopores, and / or macropores formed from porous phenolic resin. As used herein, the term "micropore" refers to a pore with a diameter of less than 2 nm as measured by nitrogen adsorption and mercury porosimetry and as defined by IUPAC. As used herein, the term "mesopore" refers to a pore with a diameter of about 2 nm to about 50 nm as measured by nitrogen adsorption and mercury porosimetry and as defined by IUPAC. As used herein, the term "micropore" refers to a pore with a diameter of more than 50 nm as measured by nitrogen adsorption and mercury porosimetry and as defined by IUPAC.

[0026] SCPs suitable for use in the present disclosure can have any shape that is compatible with the compositions and methods disclosed herein. For example, the shape of the SCP can be in the form of irregular granules, non-angular shapes, spheres (e.g., beads), pellets, miniliths, monoliths, and the like. For simplicity, the present disclosure may refer to the use of beads of the SCB, but it should be understood that the SCP can be in any suitable shape. The SCP can be formed using any suitable method to result in a material having the properties disclosed herein. In a typical method for forming the SCP, a precursor resin formulation is used that has a high ratio of pore former, for example, 250 parts ethylene glycol or other pore former to 100 parts resin forming components.

[0027] As used herein, mesoporous resins can be formed by condensing a nucleophilic component comprising a phenolic compound or a phenolic condensation prepolymer with at least one electrophilic crosslinker selected from formaldehyde, paraformaldehyde, furfural, and hexamethylenetetramine in the presence of a pore former selected from the group consisting of diols (e.g., ethylene glycol), diol ethers, cyclic esters, substituted cyclic esters, substituted linear amides, substituted cyclic amides, amino alcohols, and mixtures of any of the above with water to form a resin. The pore former is present in an amount effective to impart mesoporosity or macroporosity to the resin (e.g., at least 120 parts by weight of pore former is used to dissolve 100 parts by weight of the total resin-forming components, i.e., the sum of the nucleophilic and electrophilic components), and is removed from the condensed porous resin by cascade washing with water or vacuum drying. The resulting resin can be carbonized by heating to a temperature of at least 600°C in an inert atmosphere to result in a material with a bimodal distribution of pores, a pore structure estimated by nitrogen adsorption porosimetry that includes micropores as well as mesopores or macropores. The value of the derivative of pore volume with respect to the logarithm of pore radius (dV / d log R) for the mesopores is greater than 0.2 for at least some values ​​of pore size in the range of 20-500 Å. The BET surface area of ​​mesoporous carbon is between 250-800 m without activation. 2 The mesoporous carbon can be activated by heating at high temperatures in the presence of carbon dioxide, steam, or mixtures thereof, for example, above 800° C. in carbon dioxide, or by heating above 400° C. in air. In that case, the surface area can be, for example, 1,000-2,000 m 2 / g, up to 2,000m 2 / g or more. As used herein, the term "BET surface area" is determined by the Brunauer, Emmett, and Teller (BET) method according to ASTM D1993-91. See also ASTM D6556-04.

[0028] In some embodiments, the location of the first inlet 222 can be configured to direct the bodily fluid in a particular flow pattern, e.g., to control the flow rate and / or direction of the bodily fluid passing through the screen assembly 210 and into the cartridge body 230 prior to contacting the sorbent material 235. For example, FIG. 6 illustrates a cross-sectional view of an assembled cartridge 220, with the plane of the cross-section extending through the center of the port 290. FIG. 6 illustrates an assembled cartridge 220 (e.g., without the sorbent material disposed within the cartridge body 230). As shown in FIGS. 5 and 6 and disclosed in further detail with respect to the following figures, the first inlet 222 is located in the first end segment 220 such that bodily fluid received via the first inlet 222 is directed into the first end segment 220 in a tangential direction relative to the first end segment 220.

[0029] 7 and 8, the first end segment 220 includes a first inlet 222 disposed tangentially relative to a circular surface 320 of the first end segment 220. Additionally, the first end segment 220 may include a second inlet 223 disposed at a center (e.g., a cone point or apex) of the circular surface 320 of the first end segment 220. The second inlet 223 may extend generally perpendicular to an exterior of the first end segment 220.

[0030] The circular surface 320 of the first end segment 220 may comprise an outwardly truncated conical shape and may define an interior conical space. The circular surface 320 may be connected or joined to a cylindrical wall 330 that may extend generally parallel to a central longitudinal axis 300 of the first end segment 220. As shown, the first inlet 222 may be disposed in the cylindrical wall 330 tangentially to the circular surface 320 to tangentially direct the flow of bodily fluid entering the first end segment 220 via the first inlet 222 into the interior conical space.

[0031] Additionally, the first end segment 220 can include a ledge 340 joined to the cylindrical wall 330. The ledge 340 can extend in a plane generally perpendicular to the central axis 300 of the first end segment 220. The ledge 340 can be configured to fit over one or more elements of a cartridge to which the first end segment 220 is attached, such as, for example, a screen assembly (as previously shown) and / or a cartridge body. Additionally, the first end segment 220 can include a second cylindrical wall 350 joined to a periphery of the ledge 340, the second cylindrical wall 350 also extending generally parallel to the central axis 300 of the first end segment 220. In some embodiments, the second cylindrical wall 350 can include one or more attachment elements configured to attach the first end segment 220 to a cartridge, such as the cartridge body 230. In some embodiments, the cylindrical wall 350 can be configured to fit over a portion of the cartridge body 230. For example, the shelf 340 and / or the cylindrical wall 350 may be attached to the cartridge body 230 by an adhesive or a threaded interface.

[0032] 9 shows a top view of the first end segment 220, and FIG. 10 shows a cross-sectional view of the first end segment 220, the cross-section being taken through the second inlet 223 of the first end segment 220. In some embodiments, the second inlet 223 can comprise an inner surface or profile 312 configured to receive another element of the cartridge, such as, for example, a luer cap. The circular surface 320 can comprise an outer surface 321 and an inner surface 322. The first cylindrical wall 330 can comprise an outer surface 331 and an inner surface 332. The shelf 340 can comprise an outer surface 341 and an inner surface 342. The second cylindrical wall 350 can comprise an outer surface 351 and an inner surface 352. The circular surface 320 can further comprise a thickness 323.

[0033] In some embodiments, circular surface 320, first cylindrical wall 330, ledge 340, and second cylindrical wall 350 can cooperate to define an inner surface 360 ​​configured in whole or in part to direct fluid flow within first end segment 220. Inner surface 360 ​​can be defined by inner surface 322 of circular surface 320, inner surface 332 of first cylindrical wall 330, inner surface 342 of ledge 340, and / or inner surface 352 of second cylindrical wall 352.

[0034] In some embodiments, the inner surface 360 ​​may be defined by a curved surface 315 connecting the inner surface 312 of the second inlet 223 to the inner surface 322 of the circular surface 320. In some embodiments, the inner surface 360 ​​may include a curved surface 325 connecting the inner surface 322 of the circular surface 320 to the inner surface 332 of the first cylindrical wall 330. In some embodiments, the inner surface 360 ​​may be defined by a curved surface or protrusion 335 connecting the inner surface 332 of the first cylindrical wall 330 to the inner surface 342 of the ledge 340. In some embodiments, the inner surface 360 ​​may be defined by a curved surface 344 within the inner surface 342 of the ledge 340. In some embodiments, the inner surface 360 ​​may be defined by a curved surface 345 connecting the inner surface 342 of the ledge 340 to the inner surface 352 of the second cylindrical wall 350. In some embodiments, the second cylindrical wall 350 can include an end surface 355 that can define a base of the first end segment 220 perpendicular to the central axis 300 of the first end segment 220 .

[0035] 11 shows another side view of the first end segment 220. In some embodiments, the inclination angle 304 of the circular surface 320 relative to a plane perpendicular to the longitudinal axis 300 of the cartridge (e.g., bottom surface 355) can be between about 5° and about 30°. In some embodiments, the inclination angle 304 of the circular surface 320 relative to a plane perpendicular to the longitudinal axis 300 of the cartridge (e.g., bottom surface 355) can be between about 7° and about 15°. In some embodiments, the cylindrical wall 330 can be joined to the circular surface 320 at an angle 306 of about 95° to about 120°.

[0036] 12 shows another cross-sectional view of the first end segment 220, the cross-section being through the first inlet 222. In some embodiments, the first inlet 222 can comprise a central axis 302 perpendicular to a longitudinal axis 300 of the first end segment 220. In some embodiments, the first inlet 222 can comprise an inner surface or inner profile 224 configured to receive, for example, a luer fitting and / or a luer plug (as described above). In some embodiments, the second cylindrical surface can comprise ridges or discontinuities and an inner concentric concave ridge surface 351 having the ridges or discontinuities that may be configured to seal the first end segment 220 to a cartridge (e.g., a cartridge body).

[0037] In some embodiments, the positioning of the first inlet 222 relative to the first end segment 220 results in a flow of bodily fluid into the first end segment 220 tangential to the first end segment, such that, for example, the bodily fluid flows radially (e.g., in a spiral pattern) as it enters the cartridge 200. Without intending to be bound by theory, this flow pattern can expose the bodily fluid to less chaotic turbulent behavior compared to axial flow, for example, by increasing the path length available in the first end segment before passing through the sorbent material 235. For example, the partial conical shape of the first end segment 220, in combination with the tangential positioning of the first inlet 222, can cause the incoming bodily fluid to slow down (e.g., reduce flow velocity) and lose energy before passing through the screen assembly 210 and into the sorbent material 235.

[0038] The first end segment 220 with the first inlet 222 can provide a smoother entry into the cartridge body 230 through radial flow dynamics. The flow dynamics created by the first end segment 220 can result in a gentler entry into the cartridge body 230 through the tangential inlet 222, which may be configured to more closely mimic laminar flow by aligning the incoming blood (or bodily fluid) with the radial flow dynamics present inside the first end segment 220 and cartridge body 230. The longer path created by this direction of bodily fluid flow can reduce the flow velocity and minimize turbulence of the fluid flow before passing through the screen assembly 210. In some embodiments, the first end segment 220 can be configured to slow the bodily fluid from its velocity at entry of the bodily fluid into the first inlet 222 by about 5% to 90% of this entry velocity. In some embodiments, the first end segment 220 may be configured to slow the bodily fluid from the velocity at which the bodily fluid entered the first inlet 222 by about 5% to 50% of the inlet velocity. In some embodiments, the first end segment 220 may be configured to slow the bodily fluid from the velocity at which the bodily fluid entered the first inlet 222 by about 5% to 25% of the inlet velocity.

[0039] Conversely, in a cartridge that does not have an end segment with a tangential inlet (e.g., first end segment 220 with first inlet 222 as disclosed herein), blood axially entering a closed space filled with adsorbent material trapped by a screen mesh barrier (e.g., cartridge body 230) may exhibit sufficient velocity and turbulence to cause platelet activation and / or fibrinogen adhesion to both the screen mesh and the trapped adsorbent material. Furthermore, the resulting increase in differential pressure may cause poor flow and adsorption kinetics and negative hematological changes. When blood is passed through cartridge 200 in the manner described above, platelet activation and fibrinogen adhesion can be significantly reduced.

[0040] Thus, in some embodiments, the cartridge 200 of the present disclosure can effectively mitigate problems associated with other cartridge designs when used in an extracorporeal circuit and can be extremely advantageously used when the bodily fluid is blood or a component of blood, for example, by providing a relative reduction in (i) platelet loss, (ii) leukocyte loss, (iii) platelet clumping, (iv) increased pressure across the cartridge during operation, (v) the occurrence of thrombocytopenia, (vi) the occurrence of leukopenia, (vii) microemboli, (viii) blood debris, or a combination thereof.

[0041] Some embodiments of the present disclosure can include a method for removing one or more components present in a bodily fluid to produce a purified bodily fluid. An exemplary method can include attaching a cartridge (e.g., cartridge 200 described above) to an input of the bodily fluid. In some embodiments, the input of the bodily fluid can be an arterial blood flow from a patient. The method can include attaching the cartridge to an output of the purified bodily fluid from the cartridge. In some embodiments, the output of the purified bodily fluid can include a venous blood flow to the patient. The method can include passing the bodily fluid through the cartridge, the cartridge comprising a cartridge body configured to hold a sorbent material and an end segment configured to cover a first end of the cartridge body. The cartridge end segment may comprise a circular face having an outwardly truncated conical shape defining an interior conical space, a cylindrical wall joined around the circular face, and an inlet configured to provide communication with a source of bodily fluid, the inlet being disposed tangentially in the cylindrical wall to the circular face to direct bodily fluid entering the cartridge tangentially into the interior conical space to decelerate the bodily fluid in the interior conical space prior to contacting an adsorbent material disposed within the cartridge body. The method may further include filtering one or more substances from the bodily fluid (e.g., by an adsorbent material contained within the cartridge) to produce a purified bodily fluid.

[0042] In some embodiments, the method can include establishing a fluid connection between a pump and at least one of an input or an output of the cartridge. In some embodiments, the method can include pumping the bodily fluid through the cartridge with a pump. In some embodiments, the method can include measuring the pressure of the cartridge with a level detector. In some embodiments, the method can include withdrawing bodily fluid from the subject (e.g., via an arterial access flow path) and allowing the purified bodily fluid to flow back into the subject (e.g., via a venous return flow path).

[0043] Although various apparatus and methods have been described herein, exemplary aspects or embodiments may include, but are not limited to, the following.

[0044] In a first aspect, a cartridge for treatment of bodily fluids can comprise a cartridge body configured to hold an adsorbent material and an end segment configured to cover a first end of the cartridge body, the end segment having an outwardly truncated conical shape, a circular surface defining an interior conical space, a cylindrical wall joined to the periphery of the circular surface, and an inlet configured to provide communication with a source of bodily fluid, the inlet being positioned tangentially to the circular surface in the cylindrical wall to direct bodily fluid entering the cartridge tangentially into the interior conical space to decelerate the bodily fluid in the interior conical space before contacting the adsorbent material disposed within the cartridge body.

[0045] A second embodiment may include the cartridge of the first embodiment, further comprising an inlet luer fitting affixed to the inlet and configured to connect the cartridge to a source of bodily fluid.

[0046] A third embodiment may include the cartridge of the first or second embodiment, wherein the end segment comprises a cap configured for attachment to the cartridge body.

[0047] A fourth embodiment may include the cartridge of the third embodiment, further including an adhesive configured to attach and seal the at least one cap to the cartridge body.

[0048] A fifth embodiment may include the cartridge of any of the first to fourth embodiments, further comprising one or more screen assemblies disposed between the end segments and the cartridge body.

[0049] A sixth embodiment may include the cartridge of any of the first to fifth embodiments, wherein the end segment further comprises an inlet located at the axis of the circular surface.

[0050] A seventh embodiment may include the cartridge of any of the first to sixth embodiments, wherein the circular surface has an inclination angle of about 5° to about 30° with respect to a plane perpendicular to the longitudinal axis of the cartridge.

[0051] An eighth embodiment may include the cartridge of any of the first to seventh embodiments, wherein the circular surface has an inclination angle of about 7° to about 15° with respect to a plane perpendicular to the longitudinal axis of the cartridge.

[0052] A ninth embodiment may include the cartridge of any of the first to eighth embodiments, wherein the cylindrical wall is joined to the circular surface at an angle of from about 95° to about 120°.

[0053] In a tenth aspect, a method of removing one or more components present in a bodily fluid to produce a purified bodily fluid may include attaching a cartridge to an input of the bodily fluid, attaching the cartridge to an output of the purified bodily fluid from the cartridge, and passing the bodily fluid through the cartridge, the cartridge comprising a cartridge body configured to hold an adsorbent material and an end segment configured to cover a first end of the cartridge body, the end segment comprising an outwardly truncated conical shape and a circular surface defining an interior conical space, a cylindrical wall joined to a periphery of the circular surface, and an inlet configured to provide communication to a source of bodily fluid, the inlet being disposed tangentially in the cylindrical wall to the circular surface to direct the bodily fluid entering the cartridge tangentially into the interior conical space to decelerate the bodily fluid in the interior conical space prior to contacting the adsorbent material disposed within the cartridge body, and the method may further comprise filtering one or more substances from the bodily fluid to produce a purified bodily fluid.

[0054] An eleventh aspect may include the method of the tenth aspect, further including the step of establishing a fluid connection between the pump and at least one of the input or output of the cartridge.

[0055] A twelfth aspect may include the method of the eleventh aspect, further including pumping the bodily fluid through the cartridge with a pump.

[0056] A thirteenth aspect may include the method of any of the tenth to twelfth aspects, further including the step of measuring the pressure in the cartridge with a level detector.

[0057] A fourteenth aspect may include any of the methods of the tenth to thirteenth aspects, further including the steps of withdrawing bodily fluid from the subject and allowing the purified bodily fluid to flow again into the subject.

[0058] In a fifteenth aspect, a cartridge may comprise a cartridge body and an end segment configured to cover a first end of the cartridge body, the end segment having an outwardly truncated conical shape, a circular surface defining an interior conical space, a cylindrical wall joined to the periphery of the circular surface, and an inlet configured to provide communication with a source of bodily fluid, the inlet being positioned tangentially to the circular surface in the cylindrical wall to direct bodily fluid entering the cartridge tangentially into the interior conical space to decelerate the bodily fluid in the interior conical space before contacting the adsorbent material disposed within the cartridge body, and the cartridge may further comprise an adsorbent material retained within the cartridge body by at least one end segment.

[0059] A sixteenth embodiment may include the cartridge of the fifteenth embodiment, further comprising at least one inlet port centrally disposed in the at least one end segment and extending perpendicularly outwardly of the at least one end segment.

[0060] A seventeenth embodiment may include the cartridge of the fifteenth or sixteenth embodiments, further comprising an inlet luer fitting affixed to the inlet and configured to connect the cartridge to a source of bodily fluid.

[0061] An eighteenth embodiment may include the cartridge of the seventeenth embodiment, further comprising a luer plug configured to be attached to the inlet luer fitting.

[0062] A nineteenth aspect may include the cartridge of any of the fifteenth to eighteenth aspects, wherein the end segment comprises a cap configured for attachment to the cartridge body.

[0063] A twentieth embodiment may include the cartridge of the nineteenth embodiment, further including an adhesive configured to attach and seal the at least one cap to the cartridge body.

Claims

1. A cartridge for the treatment of a body fluid, comprising: a cartridge body configured to hold an adsorbent material; an end segment configured to cover a first end of the cartridge body; It is equipped with The end segments are a circular surface having an outwardly facing truncated conical shape and defining an interior conical space; a cylindrical wall joined to the periphery of the circular surface; a first inlet configured to provide communication with a source of the bodily fluid, the first inlet has a central axis perpendicular to a longitudinal axis of the end segment; The first inlet includes: (1) a first inlet disposed tangentially to the circular surface in the cylindrical wall to tangentially direct at least a portion of the bodily fluid entering the cartridge into the interior conical space to decelerate at least a portion of the bodily fluid in the interior conical space prior to contacting the adsorbent material disposed within the cartridge body; a second inlet disposed at an axial center of the circular surface, the second inlet configured to provide an additional path for fluid flow to the end segment.

2. The cartridge of claim 1 , further comprising an inlet luer fitting affixed to the first inlet and configured to connect the cartridge to a source of bodily fluid.

3. The cartridge of claim 1 , wherein the end segment comprises a cap configured for attachment to the cartridge body.

4. The cartridge of claim 3 , further comprising an adhesive configured to attach and seal the at least one cap to the cartridge body.

5. The cartridge of claim 1 , further comprising one or more screen assemblies disposed between the end segments and the cartridge body.

6. The cartridge of claim 1 , wherein the circular surface has an inclination angle of about 5° to about 30° with respect to a plane perpendicular to a longitudinal axis of the cartridge.

7. The cartridge of claim 1 , wherein the circular surface has an inclination angle of about 7° to about 15° with respect to a plane perpendicular to a longitudinal axis of the cartridge.

8. The cartridge of claim 1 , wherein the cylindrical wall is joined to the circular surface at an angle of from about 95° to about 120°.

9. A cartridge comprising: A cartridge body; an end segment configured to cover a first end of the cartridge body; The end segments are a circular surface having an outwardly facing truncated conical shape and defining an interior conical space; a cylindrical wall joined to the periphery of the circular surface; a first inlet configured to provide communication with a source of bodily fluid, the first inlet has a central axis perpendicular to a longitudinal axis of the end segment; The first inlet includes: (1) a first inlet disposed tangentially in the cylindrical wall relative to the circular surface to tangentially direct at least a portion of the bodily fluid entering the cartridge into the interior conical space to decelerate the at least a portion of the bodily fluid in the interior conical space prior to contacting an adsorbent material disposed within the cartridge body; a second inlet disposed at an axial center of the circular surface, the second inlet configured to provide an additional path for fluid flow to the end segment; and the sorbent material retained within the cartridge body by the at least one end segment.

10. 10. The cartridge of claim 9, further comprising an inlet luer fitting affixed to the first inlet and configured to connect the cartridge to a source of bodily fluid.

11. 11. The cartridge of claim 10, further comprising a luer plug configured to be attached to the inlet luer fitting.

12. The cartridge of claim 9 , wherein the end segment comprises a cap configured for attachment to the cartridge body.

13. The cartridge of claim 12, further comprising an adhesive configured to attach and seal the at least one cap to the cartridge body.

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