Dialysis transfer set

Abstract

A transfer set may include a tube and a cap assembly connected to the tube. The cap assembly includes a clamping member and a collar. The clamping member includes a clamp configured to engage the tube for enabling and disabling fluid flow through the tube. The collar is configured to move the clamp between a first position and a second position. When in the first position, the collar is configured to engage the clamp to disable fluid flow through the tube. When in the second position, the collar is configured to release the clamp to enable fluid flow through the tube. The cap assembly may further include a cap. The cap may be removably connected to the clamping member to protect the connector of the clamping member from foreign contaminants.

Description

Attorney Docket No. 218079.023201 (A0008816)DIALYSIS TRANSFER SETCROSS REFERENCE

[0001] This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 688,582, filed on August 29, 2024, and titled “DIALYSIS TRANSFER SET”, the entire content of which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to the field of dialysis systems. More particularly, this disclosure relates to transfer sets for dialysis systems.BACKGROUND

[0003] Renal failure can be caused due to disease, injury, or other causes. Renal failure can lead to toxic end products of nitrogen metabolism such as, for example, urea, creatinine, uric acid, and other waste products, to accumulate in the body. Renal failure and associated reduced kidney function and kidney failure can be treated with dialysis procedures to remove these toxic products from the body. Dialysis procedures include, for example, hemodialysis and peritoneal dialysis. Hemodialysis utilizes the patient’s blood to remove waste products from the patient’s body using a hemodialysis machine. Peritoneal dialysis utilizes a dialysis solution, or dialysate, which is infused into the peritoneal cavity through a catheter implanted into the cavity. The waste products diffuse from the patient’s bloodstream through the peritoneal membrane and into the dialysate, which is then drained from the cavity using the catheter after a suitable interval.SUMMARY

[0004] In some embodiments, a system includes a dialysis transfer set including a tube and a cap assembly connected to the tube, the cap assembly includes a clamping member, the clamping member includes a clamp configured to engage the tube for enabling and disabling fluid flow through the tube, and a collar configured to move the clamp between a first position and a second position. When in the first position, the collar is configured to engage the clamp to disable fluid flow through the tube. When in the second position, the collar is configured to release the clamp to enable fluid flow through the tube.Attorney Docket No. 218079.023201 (A0008816)

[0005] In some embodiments, the clamping member includes a first end and a second end opposite the first end, and the clamp is disposed at the second end of the clamping member.

[0006] In some embodiments, the clamping member further includes a connector, the connector distally extends from the second end and is connectable with the tube, and a flow channel, the flow channel extends from the first end of the clamping member to the connector.

[0007] In some embodiments, the clamping member further includes at least one groove, the at least one groove circumferentially extends around an outer surface of the clamping member; and the collar includes at least two pins, the at least two pins are circumferentially located around an inner surface of the collar, and the at least two pins are configured to engage the at least one groove to retain a position of the collar relative the clamping member.

[0008] In some embodiments, the at least one groove includes a first groove, the at least two pins are configured to engage the first groove to lock the clamp in the first position, and a second groove, the at least two pins are configured to engage the second groove to lock the clamping member in the second position, and the first groove circumferentially extends around the clamping member between the second groove and the clamp.

[0009] In some embodiments, the collar further includes one or more tab segments, the one or more tab segments are configured to enable the collar to be positioned relative the clamping member so that the at least two pins engage the at least one groove to retain the position of the collar relative the clamping member.

[0010] In some embodiments, the clamp includes a first wing and a second wing opposite the clamping member from the first wing, and the collar is configured to engage the first wing and the second wing to enable and disable the fluid flow through the tube.

[0011] In some embodiments, the collar includes a first portion, the first portion includes a first diameter, a second portion, the second portion includes a second diameter greater than the first diameter, and a third portion, the third portion is located between the first portion and the second portion, the third portion includes a sloped transition extending between the first portion and the second portion.

[0012] In some embodiments, at least one of the first portion and the third portion adjacent the first portion engages the clamp to disable fluid flow through the tube, and at least one of the second portion and the third portion adjacent the second portion engages the clamping member to enable fluid flow through the tube.Attorney Docket No. 218079.023201 (A0008816)

[0013] In some embodiments, the cap assembly further includes a cap, the cap is removably connected to the clamping member opposite the clamp, and the cap includes at least one first thread configured to engage at least one second thread located on the clamping member to connect the cap to the clamping member.

[0014] In some embodiments, a cap assembly for a dialysis transfer set, the cap assembly including a clamping member including a first end, a second end opposite the first end, a first groove, a second groove, and a clamp, the clamp is configured to engage a tube for enabling and disabling fluid flow through the tube; a collar configured to move the clamping member between a first position and a second position, when in the first position, the collar is configured to engage the clamp to disable fluid flow through the tube, and in the second position, the collar is configured to release the clamp to enable fluid flow through the tube, and a cap removably connected to the clamping member.

[0015] In some embodiments, the clamping member further including a first wing, the first wing is located at the first end, a second wing, the second wing is located at the first end opposite the first wing on the clamping member, a connector, the connector extends from the second end and is connectable with the tube, and a flow channel, the flow channel extends from the first end of the clamping member to the connector; the clamp includes the first wing and the second wing; and the collar is configured to engage the first wing and the second wing to enable and disable the fluid flow through the tube.

[0016] In some embodiments, the cap includes at least one first thread, the at least one first thread is located on an inner surface of the cap; and the clamping member further includes at least one second thread; the at least one first thread of the cap is configured to engage the at least one second thread of the clamping member to removably connect the cap to the clamping member.

[0017] In some embodiments, the collar includes at least two pins, the at least two pins are configured to act as a mechanical stop to prevent disassembly of the clamping member and the collar, the at least two pins are configured to engage the first groove to lock the clamp in the first position, and the at least two pins are configured to engage the second groove to lock the clamp in the second position.

[0018] In some embodiments, the collar further includes one or more tab segments, the one or more tab segments are configured to enable the collar to be positioned relative the clampingAttorney Docket No. 218079.023201 (A0008816) member so that the at least two pins engage one of the first groove and the second groove to retain the position of the collar relative the clamping member.

[0019] In some embodiments, the collar includes a first portion, the first portion includes a first diameter, a second portion including a retention ring, the retention ring includes an aperture configured to maintain an axial position of the tube in the retention ring, the second portion includes a second diameter greater than the first diameter, and a third portion, the third portion includes a sloped transition extending between the first portion and the second portion; the third portion adjacent the first portion engages the clamping member to disable fluid flow through the tube, and the third portion adjacent the second portion engages the clamping member to enable fluid flow through the tube.

[0020] In some embodiments, the cap includes at least one recess, the at least one recess longitudinally extends along an outer surface of the cap, the at least one recess is configured to be engageable by a user to facilitate removably connecting the cap to the clamping member.

[0021] In some embodiments, the cap includes a disinfectant solution configured to prevent contamination of the cap assembly.

[0022] In some embodiments, the clamping member further includes a valve, the valve is configured to enable and disable fluid flow through the tube.

[0023] In some embodiments, a transfer set assembly including a tube; a clamping member including a first end and a second end opposite the first end, the clamping member including a clamp, the clamp includes a plurality of wings, the plurality of wings being configured to engage the tube so as to control a fluid flow through the tube, and a connector, the connector is located between the plurality of wings, the tube being installed on the connector; and a collar including a circumferential inner surface, a portion of the inner surface includes a sloped transition having a tapered diameter, and a position of the collar is movable between a plurality of positions in an axial direction relative the clamping member, and, in response to moving the collar between the plurality of positions, the collar engages the plurality of wings so as to control the fluid flow through the tube.Attorney Docket No. 218079.023201 (A0008816)BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Some embodiments of the disclosure are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the embodiments shown are by way of example and for purposes of illustrative discussion of embodiments of the disclosure. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the disclosure may be practiced.

[0025] FIG. l is a schematic illustration of a system, according to some embodiments.

[0026] FIG. 2 is a graphical illustration of the system, according to some embodiments.

[0027] FIG. 3 is a perspective view of the transfer set, according to some embodiments.

[0028] FIG. 4 is an exploded view of the transfer set, according to some embodiments.

[0029] FIG. 5 is a sectional view of the transfer set, according to some embodiments.

[0030] FIG. 6 is another sectional view of a portion of the transfer set, according to some embodiments.

[0031] FIG. 7 is a perspective view of the transfer set, according to some embodiments.

[0032] FIGS. 8A-C are sectional views of a portion of the transfer set, according to some embodiments.

[0033] FIG. 9 is an exploded view of the transfer set, according to some embodiments.

[0034] FIG. 10 is a sectional view of the transfer set, according to some embodiments.

[0035] FIG. 11 is a sectional view of a portion of the transfer set, according to some embodiments.

[0036] FIG. 12 is a sectional view of a portion of the transfer set, according to some embodiments.

[0037] FIG. 13 is a sectional view of a portion of the transfer set, according to some embodiments.

[0038] Like reference numbers represent the same or similar parts throughout.DETAILED DESCRIPTION

[0039] Dialysis systems such as, but not limited to, hemodialysis, hemofiltration, hemodiafiltration, and peritoneal dialysis systems, can utilize flexible fluid conduits or tubing that includes an inner channel that longitudinally extends through the tubing. Medical devices can include this flexible tubing to facilitate the introduction and withdrawal of fluids to and from the body. For example, a catheter can be implanted into a body’s cavities, ducts, and vessels, to facilitate the introduction and withdrawal of fluidsAttorney Docket No. 218079.023201 (A0008816) to and from the body. The catheter includes a segment of flexible tubing that protrudes from the patient’s skin and a distal end of the flexible tubing can be connected to another medical device such as, but not limited to, transfer sets, intravenous drips, drain collectors, hemodialysis systems, and the like.

[0040] In peritoneal dialysis systems, the catheter can be implanted into the peritoneal cavity of the patient. The catheter can then be connected to a transfer set to introduce a dialysis solution, or dialysate, using the catheter. After a suitable interval, the waste solution can be drained from the body to a drain collection device through the catheter and the transfer set. The transfer set can also include one or more segments of flexible tubing that can be connected to the catheter, dialysis solution supply, drain collector, or other like devices. The flexible tubing can also be referred to as a patient line and drain line.

[0041] Various embodiments of the present disclosure relate to systems, devices, and assemblies for a transfer set. The transfer set is configured to connect a length of flexible tubing to another length of flexible tubing to allow fluid to be transferred between the respective lengths of tubing through the transfer set. For example, one end of the transfer set may be connected to a catheter implanted into a person’s peritoneal cavity and the other end of the transfer set may be connected to an intravenous (“IV”) bag of dialysate solution to provide peritoneal dialysis therapy to the person. In some embodiments, the tube may be a flexible tube including an inner channel for fluid to pass therethrough. In some embodiments, the tube may be made of silicon, or some other similar material.

[0042] According to some embodiments, the transfer set may be configured to connect to flexible tubing. The transfer set may be referred to herein as a cap assembly. In some embodiments, the transfer set may include the flexible tubing connected to the transfer set (or cap assembly), as will be further described herein. The flexible tubing may be referred to herein as a flexible tube, tubing, tube, and the like. The cap assembly includes a clamping member and a collar.

[0043] The clamping member includes a first end and a second end opposite the first end. The clamping member may be referred to herein as a transfer set connector. The clamping member includes a clamp configured to engage the tube for enabling and disabling fluid flow through the tube. In some embodiments, the clamp may be disposed at the second endAttorney Docket No. 218079.023201 (A0008816) of the clamping member to enable the clamp to move between the first position and the second position in response to the respective position of the collar.

[0044] According to some embodiments, the clamp may include a first wing and a second wing distally extending from the second end of the clamping member. The first wing may be opposite the clamping member from the first wing in the latitudinal direction. That is, the first wing and the second wing may define respective arms that extend from the second end of the clamping member at opposite sides and towards a distal end of the clamping member. In some embodiments, the collar may be configured to engage each of the first wing and the second wing to enable and disable the fluid flow through the tube.

[0045] In some embodiments, the first wing of the clamp may further include a first member disposed at a distal end of the clamping member and the second wing of the clamp may further include a second member disposed at the distal end of the clamping member. The first member and the second member angularly extend from the first wing and the second wing such that the respective ends of the first member and the second member are configured to engage the tube for enabling and disabling fluid flow through the tube as the collar moves the clamp between the first position and the second position. In this regard, the ends of the first member and the second member formed at the respective ends of the first wing and the second wing opposite a body of the clamping member may be configured to clamp (or pinch) the tubing when the collar is in the first position to disable fluid flow through the tube, and may be configured to release the tubing when the collar is in the second position to enable the fluid flow through the tube.

[0046] The clamping member further includes a connector and a flow channel. The connecter may be referred to herein as a port, interface, male adapter, and the like. The connector may be connectable with the tube. That is, the tube may be positioned onto the connector assembly at the connector to connect the tube to the cap assembly. The connector may extend from the second end of the clamping member. In some embodiments, the connector may distally extend from the second end of the clamping member. In some embodiments, the connector may extend from the second end of the clamping member between the arms of the clamp. In some embodiments, the connector may include one or more barbs or angled ridges formed on the outside of the connector to retain the tube installed onto the connector. In other embodiments, the connector may include other features including the bards or ridges,Attorney Docket No. 218079.023201 (A0008816) such that the tube can be retained onto the connector as can be appreciated by those having ordinary skill in the art.

[0047] The clamping member may include the flow channel. The flow channel may extend from the first end of the clamping member to the connector and the flow channel may place the first end of the clamping member in fluid communication with the second end. In this regard, when the transfer set is connected between, for example, the catheter flexible tubing and a peritoneal cycler flexible tubing, the fluid (e.g., dialysate) from the peritoneal cycler may flow through the flow channel of the transfer set and through the catheter.

[0048] According to some embodiments, the clamping member includes a groove that circumferentially extend around an outer surface of the clamping member. In some embodiments, the clamping member may include at least one groove. In some embodiments, the at least one groove of the clamping member includes a first groove. In other embodiments, the at least one groove of the clamping member includes a first groove, and a second groove spaced a length apart from the first groove in the longitudinal direction of the clamping member. In yet other embodiments, the clamping member may include two or more grooves.

[0049] In some embodiments, the clamping member may include at least one thread located on an outer surface of the clamping member. The at least one thread of the clamping member may be configured to engage a cap, as will be further described herein.

[0050] The collar includes a body having a cylindrical shape. The collar may be referred to herein as a transfer set collar. The collar may be configured to be positioned around the second end of the clamping member and the collar may also be configured to move relative the clamping member to cause the clamp on the clamping member to disable and enable fluid flow through the tube, as will be further described herein. In some embodiments, the collar may be positioned relative the clamping member so that the collar is positioned around the clamp and the connector. That is, the collar may be positioned around the clamping member such that the clamp and the connector are positioned in the inner channel of the collar. In some embodiments, the collar may include at least one continuously formed sidewall that is configured to extend around the clamping member when the collar is installed onto the clamping member. In other embodiments, the at least one sidewall of the collar may not be continuously formed. That is, the collar may be formed such that theAttorney Docket No. 218079.023201 (A0008816) collar circumferentially extends around a portion or a substantial portion of the clamping member to enable the collar to move relative the clamping member.

[0051] The collar may include one or more circumferential portions between ends of the collar. In some embodiments, the collar may include a first portion and a second portion. The first portion may have a first diameter. The second portion may have a second diameter greater than the first diameter. In some embodiments, the first portion may be configured to engage the first wing and the second wing of the clamp to cause the clamp to clamp the tube and disable fluid flow through the tube. In addition, the second portion may be configured to disengage the first wing and the second wing of the clamp to cause the clamp to unclamp the tube and enable fluid flow through the tube. In some embodiments, the collar may include the first portion, the second portion, and a third portion. The third portion may be located between the first portion and the second portion. In some embodiments, the third portion may include a sloped transition extending between the first portion and the second portion. In some embodiments, the third portion may be configured to engage the first wing and the second wing as the collar is moved between the first position and the second position such that the clamp disable and enables fluid flow through the tube, respectively.

[0052] The collar may be configured to engage the clamping member and thereby move the clamp between a first position and a second position, as will be further described herein. In some embodiments, in the first position, the collar may be configured to engage the clamp to disable fluid flow through the tube. In some embodiments, in the second position, the collar may be configured to release the clamp to enable fluid flow through the tube.

[0053] In some embodiments, the collar may include pins located adjacent an end of the collar that receives the clamp and the second end of the clamping member. In addition, the pins may be located around an inner surface of the collar in a circumferential direction. In some embodiments, the pins may be spaced equidistant from each other on the inner surface of the collar. In other embodiments, the collar may include an elongate protrusion circumferentially extending around the inner surface, the protrusion having a size and shape configured to engage the grooves on the clamping member. In some embodiments, the protrusion may include one or more segments circumferentially spaced apart on the inner surface of the collar.Attorney Docket No. 218079.023201 (A0008816)

[0054] The pins are configured to engage the groove on the outside of the clamping member to retain a position of the collar relative the clamping member. In some embodiments, the collar may include a plurality of pins. For example, the collar may include two, three, four, five, six, seven, or eight or more pins. In other embodiments, the collar may include at least two pins spaced equidistant from each other on the inner surface of the collar. In some embodiments, the pins may be configured to act as a mechanical stop to prevent disassembly of the cap assembly. That is, the pins may prevent or restrict removal of the collar from the clamping member.

[0055] In some embodiments, the collar may further include tab segments at the end of the collar that receives the clamping member and at least some of the pins may be located on the tab segments. The tab segments are configured to provide the end of the collar with a certain amount of flexibility to enable the pins to engage and disengage the grooves of the clamping member. That is, the tab segments enable the collar to be moved between the first groove and the second grooves to clamp the tube. For example, in some embodiments, the collar may include a first tab segment and a second tab segment opposite the first tab segment and each of the first tab segment and the second tab segment may include a pin located thereon. In some embodiments, each tab segment located on the collar may include a pin. In other embodiments, the collar may further include one or more pins in between the tab segments.

[0056] In a non-limiting example, in some embodiments, the cap assembly includes a clamping member and a collar. The clamping member includes a first groove and second groove, and the collar may include at least two pins disposed on the inner surface. The collar may be positioned by a user relative the clamping member so that the at least two pins engage one of the first groove or the second groove. The at least two pins engage the first groove to disable fluid flow though the tube and the at least two pins engage the second groove to enable fluid flow through the tube. Moreover, by engaging the first groove or the second groove, the at least two pins may retain (or lock) the position of the collar relative the clamping member until the user changes the position of the collar to the other of the first position and second position, a position therebetween, or to some other position. Moreover, in the first position where the at least two pins engage the first groove, the inner surface of the collar engages the first wing and the second wing to cause the first wing and the secondAttorney Docket No. 218079.023201 (A0008816) wing to clamp onto the tube to disable fluid flow through the tube. In the second position where the at least two pins engage the second groove, the inner surface of the collar disengages the first wing and the second wing to enable the first wing and the second wing to unclamp the tube and to enable fluid flow through the tube.

[0057] According to some embodiments, the collar may further include a retention ring. In some embodiments, the retention ring may be located in the inner channel of the collar. In some embodiments, the retention ring may be located at the second portion of the collar in the inner channel of the collar. The retention ring includes an aperture extending therethrough. The tube may be arranged so that it extends through the aperture. The retention ring may be configured to maintain an axial position and a radial position of the tube in the retention ring. In this regard, the retention ring retains the position of the tube relative the cap assembly in both the axial and radial position to limit or reduce a likelihood of clamping problems and to reduce a likelihood of leakage caused by the tube becoming disconnected from the connector.

[0058] According to some embodiments, the cap assembly may include a cap. The cap may be removably connected to the first end of the clamping member opposite the clamp. In some embodiments, the cap may include at least one thread configured to the engage at least one thread located on the clamping member. In some embodiments, the at least one thread of the cap may be located on an inner surface at the end of the cap and is configured to engage corresponding threads on the clamping member. In other embodiments, the at least one thread of the cap may be located on an outer surface at the end of the cap and is configured to engage corresponding threads on the clamping member. For example, in some embodiments, the cap may be a slide n° 3 female conical fitting threaded captive connection. In addition, in some embodiments, the cap may contain povidone iodine or other similar disinfectant solution in, for example, a sponge or in any other medium that can contain it, to prevent the contamination of the transfer set at any interruption of the therapy.

[0059] According to some embodiments, the transfer set may include a valve connected thereto. In some embodiments, the valve may be connected to the clamping assembly at the first end and the cap may be connected to the valve. The valve may be a secondary safety system configured to enable fluid to flow through the transfer set. In some embodiments, the valveAttorney Docket No. 218079.023201 (A0008816) may be a two-way valve configured to connect the transfer set to two or more other systems or devices. For example, in some embodiments, the transfer set tube may be connected to the catheter and the valve may be connected to a cycler of the peritoneal dialysis system. In yet another example, in some embodiments, the transfer set tube may be connected to the catheter and the valve may be a two-way valve that connects the transfer set to the cycler and a waste collector.

[0060] It is to be appreciated by those having ordinary skill in the art that the position of the threads on each of the cap and the clamping member are not intended to be limiting, and may be positioned on respective inner or outer surfaces to enable the cap to be removable connected to the clamping member and so that the cap can cover an interior portion of the clamping member to protect from outside contaminants from contacting the first end of the clamping member.

[0061] The embodiments of the transfer sets described herein provide one or more improvements over other transfer sets. One or more of the components of the transfer sets may be formed by injection molding. In some embodiments, one or more of the clamping member, collar, cap, valve, or any combinations thereof, may be formed by injection molding. In addition, once the components are formed, the transfer sets may be mechanically assembled without the use of any solvent.

[0062] The transfer sets described herein also provide one or more improvements related to its use over other transfer sets. The transfer sets simplify the opening and closing procedure for operating the transfer set to enable and disable the fluid flow therethrough by employing a push-pull mechanism rather other mechanisms utilized in the other transfer sets. By simplifying the mechanism for clamping and unclamping the tube, the transfer sets improve the manufacturing and assembly of the transfer sets, reduce manufacturing costs, improve the reliability of the clamping performance by the transfer sets, and reduces a likelihood of user error.

[0063] Among those benefits and improvements that have been disclosed, other objects and advantages of this disclosure will become apparent from the following description taken in conjunction with the accompanying figures. Detailed embodiments of the present disclosure are disclosed herein; however, it is to be understood that the disclosed embodiments are merely illustrative of the disclosure that may be embodied in variousAttorney Docket No. 218079.023201 (A0008816) forms. In addition, each of the examples given regarding the various embodiments of the disclosure which are intended to be illustrative, and not restrictive.

[0064] FIG. 1 is a schematic illustration of a system 100, according to some embodiments.

[0065] System 100 includes a transfer set 102. The transfer set 102 is configured to be place a catheter 108 in fluid communication with one or more other medical devices such as, for example, medical device 202 as shown in FIG. 1. The medical device 202 may be, for example, a peritoneal dialysis cycler.

[0066] The catheter 108 may be implanted in a body 206 of a patient. For example, as shown in FIG. 1, the catheter 108 may be implanted into body 206 so that the distal end 208 is in the peritoneal cavity 212 of body 206. The catheter 108 exits the body 206 at exit site 214 and is connected to transfer set 102 to facilitate the delivery and removal of fluids from body 206. In some embodiments, the catheter 108 may be implanted into another part of the body 206 such as, for example, a vein of body 206. In some embodiments, the system 100 may include catheter 108.

[0067] The transfer set 102 may include a tube 104 connected to the transfer set 102, as will be further described herein. The tube 104 may be connected to the catheter 108 and the opposite end of the transfer set 102 from the catheter 108 may be connected to the medical device 202. The distal end of tube 104 opposite the transfer set 102 may include any of a plurality of different connectors configured to removably connect the tube 104 to catheter 108 to enable fluid delivery through the fluid channel formed by the catheter 108 and the transfer set 102.

[0068] FIG. 2 is a graphical illustration of the system 100, according to some embodiments.

[0069] The transfer set 102 is configured to connect catheter 108 to one or more medical devices such as, for example, medical device 202 and medical device 204. In some embodiments, the transfer set 102 may place the catheter 108 in fluid connection with medical device 202 through flexible tube 112. In other embodiments, the transfer set 102 may place the catheter 108 in fluid connection with medical device 202 through flexible tube 112 and medical device 204 through flexible tube 114.

[0070] The transfer set 102 includes a cap assembly 120. The cap assembly 120 is configured to clamp tube 104 to occlude the flow channel of the tube 104 to enable or disable the fluid flow through the transfer set 102, thereby controlling fluid flow between the catheter 108Attorney Docket No. 218079.023201 (A0008816) and the medical device such as, for example, medical device 202, medical device 204, or both.

[0071] According to some embodiments, system 100 may include a valve 110. The valve 110 may be connected to the transfer set 102 opposite tube 104. That is, valve 110 may be connected to the first end 128 of clamping member 122, as shown in FIG. 3. The valve 110 may be a secondary safety system configured to direct fluid flow through the transfer set 102. In some embodiments, the valve 110 may be a two-way valve configured to connect the transfer set 102 to two or more other systems or devices such as medical device 202 and medical device 204. In some embodiments, the valve 110 may come pre-installed onto the transfer set 102. For example, the transfer set 102 may come packaged including valve 110 connected onto transfer set 102. In other embodiments, the valve 110 may be installed onto the end of the transfer set 102 by a user. For example, the transfer set 102 may come packaged with valve 110 as an individual component and the user may install the valve 110 onto the transfer set 102 based on need for the valve 110.

[0072] Valve 110 is configured to enable placing the transfer set 102 and catheter 108 in fluid connection with one or more other medical devices such as, for example, medical device 202, medical device 204, or both. In some embodiments, valve 110 may connect the transfer set 102 to medical device 202 through flexible tube 112. In other embodiments, valve 110 may connect the transfer set 102 to medical device 202 through flexible tube 112 and medical device 204 through flexible tube 114.

[0073] Valve 110 may include a first port for connecting to transfer set 102 and a second port for connecting to another conduit such as, for example, flexible tube 112 or flexible tube 114. In some embodiments, valve 110 may further include a third port for connecting to flexible tube 114. In this regard, for example, the valve 110 may be configured to provide three- way fluid flow between medical device 202, medical device 204, and body 206. In addition, in some embodiments, valve 110 may control a direction of fluid between body 206 and one of medical device 202 or medical device 204. For example, the valve may be a three- way valve and may be positioned to direct fluid flow between medical device 202 and body 206 to infuse dialysis solution into body 206. In another example, the three-way valve may be positioned to direct fluid flow between medical device 204 and body 206 to drain the waste dialysis solution from body 206.Attorney Docket No. 218079.023201 (A0008816)

[0074] According to some embodiments, in system 100, the tube 104 may include a connector 1 16 installed onto its end. In some embodiments, the connector 116 may be a male connector. In other embodiments, the connector 116 may be a female connector. For example, the connector 116 may be a male luer type connector. In some embodiments, the transfer set 102 may include the connector 116 located at a distal end of the tube 104.

[0075] According to various embodiments, the transfer set 102 may include a plurality of flexible tubes including tube 104. In addition, the flexible tubes may include a connector such as, for example, connector 116 installed onto the respective end of the flexible tube.

[0076] Referring to FIG. 1, the dashed lines represent components that can be connected together.

[0077] FIG. 3 is a perspective view of the transfer set 102, according to some embodiments.

[0078] The transfer set 102 includes a tube 104 and a cap assembly 120 connected to the tube 104.The cap assembly 120 includes a clamping member 122 and a collar 124. The clamping member 122 includes a clamp 126 (FIG. 4) configured to engage the tube 104 for enabling and disabling fluid flow through the tube 104. The collar 124 is configured to move the clamp 126 between a first position and a second position, as will be further described herein. In some embodiments, when in the first position, the collar 124 is configured to engage the clamp 126 to disable fluid flow through the tube 104. In addition, in some embodiments, when in the second position, the collar 124 is configured to release the clamp 126 to enable fluid flow through the tube 104.

[0079] In some embodiments, the clamping member 122 includes a first end 128 and a second end 130 opposite the first end 128. The clamp 126 is disposed at the second end of the clamping member 122. When the collar 124 is installed onto the second end 130 of the clamping member 122 such as, for example, shown in FIG. 3, the clamp 126 may be positioned in the inner channel formed by the collar 124.

[0080] Referring to FIG. 3, the cap assembly 120 further includes a cap 132. The cap 132 is configured to be installed onto the first end 128 of the clamping member 122. The cap 132 may be a protective cap configured to protect the cap assembly 120 of the transfer set 102, e.g., the first end 128 of the clamping member 122 as shown in FIG. 4, from coming into contact with foreign contaminants and to reduce a likelihood of contaminating the connection interface on the first end 128 from foreign contaminants.Attorney Docket No. 218079.023201 (A0008816)

[0081] The cap 132 may be pre-installed onto the transfer set 102 during the manufacturing and assembly stage. In some embodiments, the valve 110 may be installed onto the first end 128 of clamping member 122 on the transfer set 102 and each open port of valve 110 may include cap 132 installed thereon to protect the ports from contamination.

[0082] The cap 132 may include a recess 192 formed on the outer surface of the cap 132. The recess 192 may longitudinally extend from an end of the cap 132 and towards the end configured to connect to the clamping member 122. The recess 192 is configured to be engaged by a user to improve gripping the cap 132 and to improve removing the cap 132 from the clamping member 122. That is, the recess 192 are configured to enable the user to securely grip the cap 132 to remove the cap 132 from the clamping member 122 and the cap assembly 120, thereby improving user operation and to reduce a likelihood of contaminating the first end 128 of the clamping member 122 with foreign contaminants. In some embodiments, the cap 132 may include one or more recess 192. Referring to FIG. 3, for example, the cap 132 includes four of the recess 192. In some embodiments, the cap 132 may include a disinfectant solution such as, for example, on a sponge at an area inside the cap 132 that connects to the clamping member 122. The disinfectant solution is configured to prevent contamination of the cap assembly 120.

[0083] One or more components of transfer set 102 may be made of a medical grade material. In some embodiments, clamping member 122, collar 124, cap 132, or any combinations thereof may be made of the medical grade material. In some embodiments, the medical grade material may include, but is not limited to, polyethylene, polypropylene, polystyrene, polyester, polycarbonate, polyvinyl chloride, acrylonitrile butadiene styrene, polyamide, polymethyl methacrylate, polyether ether Ketone, polysulfone, acetal, acrylic, low density plastics, other polymeric materials, or any combinations thereof. The materials used to form the components of the transfer set 102 may also include one or more coloring agents. For example, the components of the cap assembly 120 may be the same color or different colors.

[0084] The components of the cap assembly 120 may be formed using any of a plurality of manufacturing techniques for forming a polymeric body including, but not limited to, molding, injection molding, extrusion, casting, punching, drilling, other similarAttorney Docket No. 218079.023201 (A0008816) manufacturing techniques, or any combinations thereof. For example, each of the clamping member 122, collar 124, and cap 132 may be formed by injection molding.

[0085] The tube 104 may also be made of a medical grade material. In some embodiments, the medical grade material of the tube 104 may include, but is not limited to, polyurethane, silicone, polyvinyl chloride, latex rubber, polyethylene terephthalate, nylon, polytetrafluoroethylene, elastomers, other like flexible materials, or any combinations thereof.

[0086] FIG. 4 is an exploded view of the transfer set 102, according to some embodiments.

[0087] The transfer set 102 includes the cap assembly 120. The cap assembly 120 includes the clamping member 122, collar 124, and a cap 132. In some embodiments, the cap assembly 120 may also include a tube 104 such as shown in FIG. 3.

[0088] The clamping member 122 includes a cylindrical body having the first end 128 and the second end 130 opposite the first end 128. The clamping member 122 includes clamp 126 at the second end 130. The clamp 126 includes a first wing 134 and a second wing 136 opposite the clamping member 122 from the first wing 134. The collar 124 is configured to engage the first wing 134 and the second wing 136 to enable and disable the fluid flow through the tube 104.

[0089] The clamping member 122 further includes a connector 140 and a flow channel 142. The connector 140 distally extends from the second end 130 of the clamping member 122 and is connectable with the tube 104. The flow channel 142 extends from the first end 128 of the clamping member 122 to the connector 140. The flow channel 142 places the connector 140 in fluid communication with the first end 128 of the clamping member 122 to enable fluid to flow through the flow channel 142. For example, to supply a dialysate from a cycler to a catheter through the transfer set 102.

[0090] The clamping member 122 further includes grooves 144. The grooves 144 circumferentially extend around an outer surface 158 of the clamping member 122. In some embodiments, the clamping member 122 includes one groove 144. In other embodiments, the clamping member 122 includes two grooves 144. In yet other embodiments, the clamping member 122 includes more than two grooves 144.

[0091] The collar 124 includes pins 146. The pins 146 are circumferentially located around an inner surface 148 of the collar 124. The pins 146 are configured to engage the grooves 144Attorney Docket No. 218079.023201 (A0008816) to retain a position of the collar 124 relative the clamping member 122. In this regard, the size and dimensions of the at least two pins 146 may be dependent on the size and dimensions of the at least one groove 144 such that the pins 146 may engage the at least one groove 144 to retain the position of the collar 124 relative the clamping member 122 until a user changes the position of the collar 124 relative the clamping member 122. In some embodiments, the collar 124 includes at least two pins 146. In other embodiments, the collar 124 includes four pins 146. In yet other embodiments, the collar 124 includes four or more pins 146. In some embodiments, the pins 146 may be configured to act as a mechanical stop to prevent disassembly of the collar 124 from the clamping member 122.

[0092] Referring to FIG. 4, the viewable portion of collar 124 is shown including three pins 144 spaced equidistant part on the inner surface 148 of the collar 124. Referring again to FIG. 3, the at least one groove 144 includes a first groove 144a and second groove 144b, which may hereinafter also be referred to as grooves 144. The pins 146 are configured to engage the first groove 144a to lock the clamp in the first position, and the pins 146 are configured to engage the second groove 144b to lock the clamp 126 in the second position. In some embodiments, the first groove 144a circumferentially extends around the clamping member 122 between the second groove 144b and the clamp 126.

[0093] The collar 124 further includes tab segments 150. In some embodiments, the collar 124 includes one or more tab segments 150. The tab segments 150 are configured to enable the collar 124 to be positioned relative the clamping member 122 so that the pins 146 engage the grooves 144 to retain the position of the collar 124 relative the clamping member 122. One or more of the pins 146 may be located on each of the tab segments 150. For example, each tab segment 150 located on the collar 124 may include a pin 146 for engaging the grooves 144 on the clamping member 122. In some embodiments, the collar 124 may include four of the tab segment 150 circumferentially spaced equidistant from each other at the end of the collar 124, and each of the tab segments 150 may include one or more of the pins 146 located thereon for engaging the grooves 144 of the clamping member 122. Referring to FIG. 4, one of the pins 146 is shown to include the tab segments 150. However, it is to be appreciated by those having ordinary skill in the art that the collar 124 may include one or more of each of the grooves 144, pins 146, and tab segments 150 to enableAttorney Docket No. 218079.023201 (A0008816) the collar 124 to move relative the clamping member 122 to engage the clamp 126 into the first position, the second position, a position therebetween, or another position.

[0094] The cap assembly 120 further includes a cap 132. The cap 132 is configured to be removably connected to the clamping member 122 opposite the clamp 126. The cap 132 includes at least one first thread 154 configured to engage threads located on the first end 128 of the clamping member 122. That is, the clamping member 122 may further include at least one second thread 156 located on the first end 128 of the clamping member 122, and the at least one first thread 154 of the cap 132 may engage the at least one second thread 156 on the clamping member 122 to connect the cap 132 to the clamping member 122.

[0095] According to some embodiments, the cap 132 includes member 138 and member 160. The member 138 is located at one end of the cap 132 and the member 160 is located at the other end of the cap 132 opposite the member 138. In some embodiments, the member 160 may be a sidewall. The member 160 includes thread 154 formed on its surface. In some embodiments, the thread 154 may be one or more threads. In other embodiments, the cap 132 may include a plurality of threads 154 formed thereon. In some embodiments, the thread 154 may be formed on an inner surface of member 160. In other embodiments, the thread 154 may be formed on an outer surface of the member 160. The size, shape, and dimensions of the thread 154 on the member 160 may correspond to the size, shape, dimensions of the threads 156 on the clamping member 122. In some embodiments, the location of the thread 154 on member 160 may depend on the corresponding location of the thread 156 on the clamping member 122.

[0096] The clamping member 122 includes thread 156. In some embodiments, the thread 156 may be one or more threads. In other embodiments, the thread 156 may be a plurality of threads 156. In some embodiments, the thread 156 on clamping member 122 may be formed on an outer surface 158 of the clamping member 122. In other embodiments, the thread 156 may be formed on an inner surface of the clamping member 122 at the first end 128, as will be further described herein.

[0097] The cap 132 may be installed onto the clamping member 122 by the thread 154 engaging the thread 156 of clamping member 122 such as, for example, shown in FIG. 5. In other embodiments, the thread 154 may be formed on an outer surface of cap 132 and the threadAttorney Docket No. 218079.023201 (A0008816)156 may be formed on an inner surface of the clamping member 122 so that the thread 154 and thread 156 may engage each other to connect the cap 132 to clamping member 122.

[0098] FIG. 5 is a sectional view of the transfer set 102, according to some embodiments.

[0099] The collar 124 includes a body 170 having a cylindrical shape. The collar 124 includes a first portion 172 and a second portion 174. The first portion 172 includes a first diameter and the second portion 174 includes a second diameter greater than the first diameter. The collar 124 is configured to be installed onto the clamping member 122 at the second end 130. The collar 124 can move in an axial direction relative to clamping member 122 between the grooves 144a and the grooves 144b as shown by the dashed line in FIG. 5. In addition, the collar 124 may include a profile such that the inner surface 148 of the collar 124 engages the first wing 134 and the second wing 136 of the clamp 126 of the clamping member 122 to enable and disable fluid flow through the tube 104 installed onto the connector 140.

[0100] Referring to FIG. 5, the collar 124 may further include a third portion 176. The third portion 176 is located between the first portion 172 and the second portion 174. The third portion 176 includes a sloped transition extending between the first portion 172 and the second portion 174. In this regard, the third portion 176 includes a tapered diameter in that an inner diameter of the third portion 176 near the first portion 172 is less than an inner diameter of the third portion 176 near the second portion 174.

[0101] By moving a position of the collar 124 in an axial direction relative the clamping member 122, the collar 124 may be positioned relative clamping member 122 so that the pins 146 are located in one of the grooves 144 located on an outer surface of the clamping member 122. In some embodiments, the clamping member 122 may include groove 144a and grove 144b, and the collar 124 may be adjustable by a user between the respective grooves 144a, 144b so that the pins 146 on collar 124 move between the groove 144a and groove 144b. In moving the collar 124 so that the pins 146 on the collar 124 move between groove 144a and groove 144b, the sloped transition of the third portion 176 engages or disengages, respectively, the first wing 134 and second wing 136 of the clamp 126 to disable or enable fluid flow through the tube 104 and the transfer set 102. In some embodiments, at least one of the first portion 172 and the third portion 176 adjacent the first portion 172 engages the clamp 126 to disable fluid flow through the tube 104. In addition, in some embodiments,Attorney Docket No. 218079.023201 (A0008816) at least one of the second portion 174 and the third portion 176 adjacent the second portion 174 engages the clamp 126 to enable fluid flow through the tube 104.

[0102] According to some embodiments, the clamping member 122 may include a plurality of grooves 144 that circumferentially extend around an outer surface of the clamping member 122. The plurality of grooves 144 being arranged along a longitudinal length of the clamping member 122 in the axial direction. That is, each of the plurality of grooves 144 may be spaced a distance apart between the first end 128 and the second end 130 of the clamping member 122. In addition, the collar 124 may be movably positioned relative the collar 124 in an axial direction so that the pins 146 on the collar 124 engages one of the plurality of grooves 144. By adjusting the position of the collar 124 relative the clamping member 122 so that the pins 146 on collar 124 are arranged in a respective one of the plurality of grooves 144 on the clamping member 122, the inner surface of the collar 124 may engage the clamp 126 (e.g., the first wing 134 and the second wing 136) so as to control or throttle the fluid flow through the tube 104.

[0103] In some embodiments, by positioning the collar 124 relative the clamping member 122 so that the pins 146 on collar 124 are arranged in a groove of the plurality of grooves 144 that is nearest to the second end 130 of clamping member 122, the inner surface of the collar 124 may engage the clamp 126 so as to stop the flow of fluid through the tube 104. In this regard, the diameter of the inner surface of collar 124 engaging the clamp 126 may be at its relative narrowest diameter. Accordingly, the relatively narrow inner diameter of the collar 124 causes the clamp 126 to engage, or pinch, the tube 104 so as to stop fluid flow through the tube 104. In some embodiments, when the pins 146 of collar 124 are in the respective groove of the plurality of grooves 144 nearest the second end 130, the collar 124 engages with the first wing 134 and second wing 136 to cause the first wing 134 and second wing 136 to pinch the tube 104 and stop the flow of fluid through the tube 104.

[0104] In some embodiments, by positioning the collar 124 relative the clamping member 122 so that the pins 146 on collar 124 are arranged in a respective groove of the plurality of grooves 144 that is nearest to the first end 128 of clamping member 122, the inner surface of the collar 124 may engage the clamp 126 so as to enable the full flow of fluid through the tube 104. In this regard, the diameter of the inner surface of collar 124 engaging the clamp 126 may be at its relative widest diameter (as compared to when the pins 146 areAttorney Docket No. 218079.023201 (A0008816) located in the groove nearest the second end 130). Accordingly, the relatively wider inner diameter of the collar 124 causes the clamp 126 to disengage, or unclamp, the tube 104 so as to enable the flow of fluid through the tube 104. In some embodiments, when the pins 146 on collar 124 are in the respective groove of the plurality of grooves 144 nearest the first end 128, the collar 124 disengages the first wing 134 and the second wing 136 to cause the first wing 134 and the second wing 136 to disengage the tube 104 and allow the flow of fluid through the tube 104.

[0105] In addition, in some embodiments, by positioning the collar 124 relative the clamping member 122 so that the pins 146 on the collar 124 are located in one of the grooves of the plurality of grooves 144 between the groove nearest the first end 128 and the groove nearest the second end 130, the fluid flow through the tube 104 may be controlled by using the collar 124 to adjust the clamping force applied to the tube 104. In some embodiments, as the position of the pins 146 on collar 124 are sequentially moved to a respective groove of the plurality of grooves 144 in the axial direction from the groove nearest the second end 130 to the groove nearest the first end 128, the fluid flow through the tube 104 may gradually increase. That is, as the position of the collar 124 moves towards the first end 128, the force being applied onto the tube 104 by the clamp 126 may gradually decrease so that the fluid flow through the tube 104 goes from being blocked to being fully open. Correspondingly, in some embodiments, as the position of the pins 146 on collar 124 are sequentially moved to a respective groove of the plurality of grooves 144 in the axial direction from the groove nearest the first end 128 to the groove nearest the second end 130, the fluid flow through the tube 104 may gradually decrease. That is, as the position of the collar 124 moves towards the second end 130, the force being applied onto the tube 104 by the clamp 126 may gradually increase so that the fluid flow through the tube 104 goes from being fully open to being blocked.

[0106] The clamping member 122 may include a member 178 located at the first end 128. The flow channel 142 of clamping member 122 may extend through the member 178, thereby placing the tube 104 in fluid communication with the first end 128 of the clamping member 122. In this regard, the member 178 may be configured to place the flow channel 142 of clamping member 122 in fluid connection with the fluid channel of another flexible tube connector assembly. When tube 104 is installed onto the connector 116 and the clampingAttorney Docket No. 218079.023201 (A0008816) member 122 is connected to the connector of the other flexible tube connector assembly at first end 128, the flow channel 142 extends from the tube 104 to the other connector through clamping member 122 and member 178, thereby placing tube 104 in fluid communication with the other connector. For example, the cycler may connect to the first end 128 of the clamping member 122, and the member 178 places the flow channel 142 in fluid communication with the cycler to enable the flow of fluid between tube 104 and the cycler to provide therapy.

[0107] The member 178 may protrude from the first end 128 of the clamping member 122, the flow channel 142 extending through the member 178 to a distal end thereof. In some embodiments, the member 178 may include a conical shape. In some embodiments, the diameter of the member 178 may be narrower at a distal end as compared to an end adj acent the first end 128 of clamping member 122.

[0108] The clamping member 122 may also include member 180 at the first end 128. The member 180 may include the at least one second thread 156 formed thereon to enable connecting the clamping member 122 to other components including, but not limited to, cap 132, catheters, fluid line connectors, medical devices, and the like. For example, a flexible tube connector assembly such as, for example, for a cycler may include threads configured to engage the at least one second thread 156 to attach the connector of the cycler to the clamping member 122 to enable the flow of fluid through the transfer set 102 between the cycler and tube 104. In some embodiments, the member 180 may be a sidewall extending away from the first end 128 of the clamping member 122. In some embodiments, the at least one second thread 156 may be formed on an outer surface of the member 180. In other embodiments, the at least one second thread 156 may be formed on an inner surface of the member 180.

[0109] According to some embodiments, the transfer set 102 includes cap 132. The cap 132 may include one or more features so as to enable installing the cap 132 onto the first end 128 of the clamping member 122. That is, the cap 132 may include one or more features including, but not limited to, protrusions, threads, sidewalls, and the like, that complement one or more features at the first end 128 of the clamping member 122 for installing the cap 132 onto the clamping member 122. In some embodiments, the one or more features of the cap 132 may be configured to seal the flow channel 142 opening at a distal end of the memberAttorney Docket No. 218079.023201 (A0008816)178. In some embodiments, the cap 132 may be configured to engage the at least one second thread 156 on the member 180. In some embodiments, the cap 132 may be installed onto the clamping member 122 to protect the first end 128 and the flow channel 142 from contamination. In some embodiments, the cap 132 may come pre-installed on the clamping member 122 during a manufacturing or assembly stage.

[0110] The cap 132 may include member 138, member 152, and member 160. In some embodiments, the cap 132 may be an integrally formed member. In some embodiments, the member 138, member 152, and the member 160 may be integrally formed together. In other embodiments, the cap 132 may include one or more members that may be connected together using one or more techniques including, but not limited to, friction fit, interference fit, welding, epoxy, glue, fasteners, resin, tape, other like techniques, or any combinations thereof.

[0111] The cap 132 may include a member 138. The member 138 may be configured to be engaged by a user for installing and / or removing the cap 132 from the clamping member 122. The member 138 may include a recess 192 formed on an outer surface of the member 138. In some embodiments, the member 138 may include a plurality of recesses 192 formed on the outer surface. In some embodiments, the recess 192 may longitudinally extend from a distal end of the cap 132 and towards the end that connects to and engages the clamping member 122 on the member 138. The recesses 192 may be configured to facilitate the user installing and / or removing the cap 132 from the clamping member 122. That is, the recess 192 is configured to facilitate the user’s ability to grip the cap 132 for removal or installation. Accordingly, the recess 192 on the member 138 facilitates engagement of the cap 132 by the user, improves user operation, and reduces a likelihood of contaminating the first end 128 of the clamping member 122 with foreign contaminants. In some embodiments, the member 138 may include a single recess 192. In other embodiments, the member 138 may include two recesses 192. In yet other embodiments, the member 138 may include three or more recesses 192.

[0112] The cap 132 may include a member 152. The member 152 may be located at an end of the cap 132 configured to engage the clamping member 122. In some embodiments, the member 152 may extend from the member 138. In some embodiments, the member 152 may be a protrusion. The member 152 may include a shape, size, and dimensions thatAttorney Docket No. 218079.023201 (A0008816) correspond to a shape, size, and dimensions of the member 178 to enable the cap 132 to seal the flow channel 142. In some embodiments, the member 152 may include a bore extending therethrough. In other embodiments, the member 152 may include a conical bore extending therethrough. In some embodiments, the bore may extend through the member 152 from a distal end to the member 138.

[0113] The cap 132 may include member 160. The member 160 may be located at the end of the cap 132 around the member 152. In some embodiments, the member 160 may circumferentially extend around the member 160. The member 160 may be configured to engage the clamping member 122. In some embodiments, the member 160 may extend from an end of the member 138. The member 160 may include a shape, size, and dimensions that correspond to a shape, size, and dimensions of the member 180 to enable the cap 132 to be installed onto and removed from the clamping member 122. In some embodiments, the member 160 may be a sidewall including threads that correspond to the at least one second thread 156 located on member 180 to enable connecting the cap 132 to the clamping member 122.

[0114] The cap 132 may include a disinfectant solution such as, for example, applied onto a sponge 186. The sponge 186 and the disinfectant solution may be located in the cap 132 where the cap 132 is configured to contact the clamping member 122 near the flow channel 142 opening. In some embodiments, the sponge 186 may be installed into a bottom of the bore extending through the member 152. Accordingly, when the cap 132 is installed onto clamping member 122, the disinfectant solution may be applied onto the surfaces in the cap 132 and the surfaces of the member 178 to prevent or limit contamination at the first end 128 of the clamping member 122.

[0115] FIG. 6 is another sectional view of a portion of the transfer set 102, according to some embodiments.

[0116] The clamping member 122 may further include a retention ring 182. The retention ring 182 may include an aperture 184 extending therethrough. The retention ring 182 is configured to maintain an axial position of the tube 104 in the retention ring 182. In some embodiments, the retention ring 182 is configured to also maintain a radial position of the tube 104 in the retention ring 182. The retention ring 182 is configured to retain the position of the tube 104 relative the cap assembly 120 in both the axial and radial position to limit or reduce aAttorney Docket No. 218079.023201 (A0008816) likelihood of clamping problems such as, for example, the tube 104 becoming occluded or blocked due to collapsing on itself or due to unintentionally becoming pinched by part of the cap assembly 120. In addition, the retention ring 182 is configured to reduce a likelihood of leakage such as, for example, from the tube 104 becoming disconnected from the connector 140.

[0117] In some embodiments, the first wing 134 of the clamp 126 may further include a first member 188 disposed at a distal end of the clamping member 122 and the second wing 136 of the clamp 126 may further include a second member 190 disposed at the distal end of the clamping member 122. The first member 188 and the second member 190 angularly extend from the respective first wing 134 and the second wing 136 such that the first member 188 and the second member 190 are configured to engage the tube 104 for enabling and disabling fluid flow through the tube 104 as the collar 124 moves the clamp 126 between the first position and the second position. In this regard, the ends of the first member 188 and the second member 190 formed at the respective ends of the first wing 134 and the second wing 136 opposite a body of the clamping member 122 and may be configured to clamp (or pinch) the tube 104 when the collar 124 is in the first position (i.e., pins 146 in groove 144a) to disable fluid flow through the tube 104, and may be configured to release the tube 104 when the collar 124 is in the second position (i.e., pins 146 in groove 144b) to enable the fluid flow through the tube 104. In some embodiments, the first member 188 and the second member 190 may extend from the respective first wing 134 and second wing 136 in a direction substantially perpendicular to the direction of the first wing 134 and second wing 136.

[0118] Turning to FIG. 7, an embodiment of a transfer set 700 having a rotatable collar 706 to permit fluid flow or prevent fluid flow is shown. The transfer set 700 is the same or similar to the transfer set 102 in certain aspects and that some of the differences between the transfer set 700 and the transfer set 102 are discussed. Parts shared between the transfer set 700 and the transfer set 102 may not be redescribed, for brevity. However, it will be appreciated that other differences may exist without departing from the scope of this disclosure.

[0119] In some embodiments, the transfer set 700 can include a removable cap assembly 702 which prevents the components at one end of the transfer set 700 from being contaminated,Attorney Docket No. 218079.023201 (A0008816) while not in use. In some embodiments, the transfer set 700 can include a transfer set body and clamp assembly 704 that defines at least a portion of a fluid path 1012 through the transfer set 700. In some embodiments, the transfer set 700 can include a collar assembly 706 which can be rotated about an axis defined by the fluid path 1012 through the transfer set 700 from a closed position, thereby occluding the flow path through the transfer set 700, and an open position, which permits fluid flow through the flow path. In some embodiments, the transfer set 700 can include a tube assembly 708 connectable to the rotatable collar 706 and includes a tube flow path that permits fluid to travel through the tube assembly 708. In some embodiments, the transfer set 700 can include an end connector assembly 710 that is configured to connect to the tube assembly 708 at one end and connect to another assembly at a second end. For example, the end connector assembly 710 can connect to the tube assembly 708 and the catheter 108 to allow the fluid to flow from the transfer set 700 to the body 206.

[0120] In some embodiments, the transfer set 700 can include a removable cap assembly 702 which keeps the components at that end of the transfer set 700 from being contaminated while not in use. The removable cap assembly 702 can include, in some embodiments, a plurality of recesses 712 formed on the outer surface of a cap 714 which can permit a user to grip the removable cap assembly 702. In some embodiments, the removable cap assembly 702 can include the cap 714, which can serve as the rigid body of the removable cap assembly 702. In use, when the removable cap assembly 702 is attached to the transfer set 700, the patient or user can rotate the removable cap assembly 702 to disengage, or engage, the removable cap assembly 702 from the transfer set 700. For example, while the transfer set 700 is idle, in transit to the place of care, in between dialysis therapy sessions, is disconnected from the medical device 202, or any combination thereof, having the removable cap assembly 702 attached to the clamp assembly 704 can prevent entry of any foreign contaminates onto, or into, the clamp assembly 704. When the patient or user goes to the use the transfer set 700, a simple rotation of the removable cap assembly 702 can be executed to remove the removable cap assembly 702 from the transfer set 700, permitting its use.

[0121] The removable cap assembly 702 can include, in some embodiments, a plurality of recesses 712 formed on the outer surface of a cap 714. The plurality of recesses 712 canAttorney Docket No. 218079.023201 (A0008816) longitudinally extend from an end of the cap 714 and towards the end configured to connect to the clamp assembly 704. The plurality of recesses 712 is configured to be engaged by a user to improve gripping the cap 714 and to improve removing the cap 714 from the clamp assembly 704. That is, the plurality of recesses 712 are configured to enable the user to securely grip the cap 714 to remove the cap 714 from the clamp assembly 704, thereby improving user operation and to reduce a likelihood of contaminating a first end of the clamp assembly 704 with foreign contaminants. In some embodiments, the cap 714 may include one or more plurality of recesses 712. Referring to FIG. 7, for example, the cap 714 includes up to eight individual recesses of the plurality of recesses 712. In some embodiments, the cap 714 includes eight individual recesses of the plurality of recesses 712. In some embodiments, the cap 714 includes at least six individual recesses of the plurality of recesses 712.

[0122] In some embodiments, the removable cap assembly 702 can include the cap 714, which can serve as the rigid body of the removable cap assembly 702. In some embodiments, the cap 714 can include a disinfectant solution such as, for example, on a sponge at an area inside the cap 714 that connects to the clamp assembly 704. The disinfectant solution is configured to prevent contamination of the removable cap assembly 702.

[0123] In some embodiments, the transfer set 700 can include a transfer set body and clamp assembly 704 that defines at least a portion of a flow path through the transfer set 700. The clamp assembly 704 can include a body portion 716 that interfaces with the rotatable collar 706 of the transfer set 700.

[0124] In some embodiments, the body portion 716 can include an open indicator 718 and a closed indicator 720. When the user rotates the rotatable collar 706, the user can align a setting indicator 722 with either the open indicator 718 or the closed indicator 720 disposed on the body portion 716. When the setting indicator 722 on the rotatable collar 706 aligns with the closed indicator 720 on the body portion 716, the clamp (see FIG. 10), will occlude the flow path and prevent flow through the transfer set 700. When the setting indicator 722 on the rotatable collar 706 aligns with the open indicator 718, the clamp will have disengaged from the flow path to permit fluid flow through the 700. For example, the user can visually discern, through use of the open indicator 718, the closed indicator 720 and the setting indicator 722, whether fluid can flow through the transfer set 700. In some embodiments,Attorney Docket No. 218079.023201 (A0008816) the user can determine if the transfer set 700 is off or on, based on the open indicator 718, the closed indicator 720 and the setting indicator 722. In some embodiments, the closed indicator 720 and the open indicator 718 are separated by about a 90-degree angle. In some embodiments, the closed indicator 720 and the open indicator 718 are separated by greater than about a 90-degree angle. In some embodiments, the closed indicator 720 and the open indicator 718 are separated by about a 180-degree angle.

[0125] In some embodiments, the transfer set 700 can include a rotatable collar assembly 706 which can be rotated about an axis defined by the flow path through the transfer set 700. In some embodiments, the rotatable collar 706 can include the setting indicator 722. The rotatable collar 706 can be configured to rotate clockwise, counterclockwise, both, or any combination thereof. When in the closed position, the rotatable collar 706 is configured to act on a clamp 1006, pushing the clamp 1006 inwards. In some embodiments, a tube 724 can be inserted into the rotatable collar 706 to fluidly connect the tube assembly 708 and the body and clamp assembly 704. When the tube 724 is connected and the transfer set 700 is in the closed position, the clamp will act on the tube 724 to occlude the tube 724, preventing fluid from flowing past the clamp 1006.

[0126] In some embodiments, the transfer set 700 can include a tube assembly 708 connectable to the rotatable collar 706 and includes a tube flow path that permits fluid to travel through the tube assembly 708. The tube assembly 708 can include the tube 724 which is connectable to the body portion 716 and the end connector assembly 710, permitting fluid communication between the body portion 716 and the end connector assembly 710. In some embodiments, the tube 724 is inserted through an aperture in the rotatable collar 706.

[0127] In some embodiments, the tube assembly 708 can include a cuff 726. The cuff 726 is configured to provide the user an ergonomic surface to hold and manipulate the tube assembly 708. In some embodiments, the cuff 726 can provide structural support for the connection between the tube assembly 708 and the end connector assembly 710.

[0128] In some embodiments, the transfer set 700 can include an end connector assembly 710 that is configured to connect to the tube assembly 708 at one end and connect to another assembly at a second end. For example, the end connector assembly 710 can connect to the valve 110, the flexible tube 112 directly to the medical device 202, the catheter 108, or any combination thereof.Attorney Docket No. 218079.023201 (A0008816)

[0129] In reference to FIGS. 8A-C, the rotation to open or block fluid flow through the transfer set 700 is shown, according to some embodiments. In some embodiments, the transfer set 700 can include a rotatable collar 706 that can be twisted, rotated, adjusted, or any combination thereof, from a closed position, shown in FIG. 8A, to an open position, shown in FIG. 8C. To transition from the closed position to the open position of the transfer set 700, the user rotates the rotatable collar 706 until the setting indicator 722 moves from being aligned with the closed indicator 720 to being aligned with the open indicator 718. In some embodiments, the rotatable collar 706 is rotatable in the direction 802. In some embodiments, the rotatable collar 706 is rotatable in the direction 802, a direction opposite to the direction 802, both, or any c combination thereof. When in the closed position, shown in FIG. 8A, fluid cannot flow through the transfer set 700. For example, the tube 724 can be occluded in the closed position. When in the open position, shown in FIG. 8C, fluid is permitted to flow through the transfer set 700 as the tube 724 is no loner being occluded because of the rotation of the rotatable collar 706.

[0130] Turning to FIG. 9, an exploded view of the transfer set 700 is shown, according to some embodiments. In some embodiments, the clamp assembly 704 can include an integrated clamp portion 912. The integrated clamp portion 912 can, in some embodiments, be welded to the body portion 716 of the clamp assembly 704. The integrated clamp portion 912 can extend from a proximal connector 910 to a clamp 1006 (see FIG. 10). The integrated clamp portion 912 can include a distal connector 902 configured to connect to the tube 724 and the proximal connector 910 configured to fluidly connect to the medical device 202, the valve 110, or any combination thereof, to permit fluid to flow through the transfer set 700 when the transfer set 700 is in the open position.

[0131] In some embodiments, the clamp assembly 704 can include a proximal ring 904 and a distal ring 906, which can be manufactured with a different material from the integrated clamp portion 912 to enhance a seal between the clamp assembly 704 and a connection to the valve 110, the flexible tube 112, the medical device 202, or any combination thereof. In some embodiments, the proximal ring 904 and the distal ring 906 are a softer material than the integrated clamp portion 912. In some embodiments, the proximal ring 904 and the distal ring 906 are thicker but can have a lower hardness than the integrated clamp portion 912, to enhance a seal at the locations of the distal ring 906 and the proximal ring 904. ForAttorney Docket No. 218079.023201 (A0008816) example, the proximal ring 904 and the distal ring 906 can be made from a material with a lower Young’s Modulus than the material of integrated clamp portion 912, such as the material of the threading 908. In some embodiments, the proximal ring 904 and the distal ring 906 can be created by over molding a softer material on the integrated clamp portion 912 to enhance sealing with the clamp assembly 704. In some embodiments, because of the distal ring 906 and the proximal ring 904 the seal created can be an hermetic seal, thereby preventing foreign contaminants, including airborne contaminates.

[0132] In some embodiments, the clamp assembly 704 can include a threading 908 on a proximal portion of the clamp assembly 704. The thread 908 can engage a complimentary threading on a connecting component to increase the surface area between the proximal portion of the clamp assembly 704 and the connecting component, thereby securing the connecting component to the clamp assembly 704. For example, the removable cap assembly 702 can include a complimentary threading 1002 on an interior of the cap 714 that engages with the threading 908 on the clamp assembly 704. This can prevent inadvertent removal of the removable cap assembly 702 from the clamp assembly 704. In some embodiments, the threading 908 can be standard ISO 80369-7 and compatible with similarly threaded medical equipment.

[0133] In reference to FIG. 10, a cross-section of the transfer set 700, according to some embodiments, is shown. The removable cap assembly 702 can include the complimentary threading 1002 on the interior wall 1004 of the cap 714. The complimentary threading 1002 can be configured to mate with the threading 908 on the body portion 716 of the clamp assembly 704. The thread 908 and the complimentary threading 1002 mate to keep the removable cap assembly 702 attached to the clamp assembly 704. In some embodiments, the proximal ring 904 and the distal ring 906 can exert an outward force onto the interior wall 1004 to maintain the attachment of the removable cap assembly 702 to the clamp assembly 704. For example, in some embodiments, the distal ring 906 and proximal ring 904 are a softer material than the integrated clamp portion 912, including the threading 908 of the integrated clamp portion 912, and are compressed when the removable cap assembly 702 is screwed onto the clamp assembly 704. In some embodiments, the removable cap assembly 702 can be pushed onto the clamp assembly 704, where the threading 908 andAttorney Docket No. 218079.023201 (A0008816) the complimentary threading 1002 align, after the initial force, to maintain the attachment of the removable cap assembly 702 to the clamp assembly 704.

[0134] In some embodiments, the 716 can be attached to the integrated clamp portion 912 at an attachment region 1008. In some embodiments, the body portion 716 can be welded to the integrated clamp portion 912 at the attachment region 1008. For example, in some embodiments, the body portion 716 can be ultrasonically welded to the integrated clamp portion 912 at the attachment region 1008. In some embodiments, the body portion 716 can be adhered to the integrated clamp portion 912 through an adhesive at the attachment region 1008. In some embodiments, the body portion 716 can be heat- welded to the integrated clamp portion 912 at the attachment region 1008. In some embodiments, the body portion 716 is attached to the integrated clamp portion 912 at various regions, which can include the attachment region 1008.

[0135] In some embodiments, as discussed above, the integrated clamp portion 912 can include the distal connector 902. The distal connector 902 can be at a distal region of the clamp assembly 704. The distal connector 902 can, in some embodiments, fluidly connect the clamp assembly 704 to the patient through the tube 724. In some embodiments, the distal connector 902 can include at least one barb 1010. The at least one barb 1010 can create a fluid seal between the distal connector 902 and the tube 724, when the tube 724 is connected to the distal connector 902. For example, when the tube 724 is attached to the distal connector 902, the at least one barb 1010 can be compressed by the tube 724, thereby creating the seal between the distal connector 902 and the tube 724. The seal between the 902 and the tube 724 prevents fluid leaks. In some embodiments, the at least one barb can be about 3.5 mm by 5.5 mm in size.

[0136] Still in reference to FIG. 10, the clamp assembly 704 can include, or define, a fluid path 1012 through which a fluid can travel. For example, a dialysis fluid can pass through the 1012. In some embodiments, the fluid path 1012 in the clamp assembly 704 extends from the proximal connector 910 to the distal connector 902. In some embodiments, the fluid path 1012 can include a first region 1013 of the fluid path 1012 and a second region 1014 of the fluid path 1012. The first region 1013 of the fluid path 1012 can have a conical shape, having the largest radius at the proximal end of the proximal connector 910 and a smaller radius at the distal end of the proximal connector 910. The conical shape can, in someAttorney Docket No. 218079.023201 (A0008816) embodiments, smooth the fluid flow entering the fluid path 1012 through the proximal connector 910, reducing the turbulence of the fluid flow therethrough. In some embodiments, the conical shape can act to increase the speed of the fluid flow. In some embodiments, the second region 1014 of the fluid path 1012 can have a cylindrical shape with a constant radius.

[0137] In some embodiments, the clamp assembly 704 can include the clamp 1006 that extends away from the distal connector 902. The clamp 1006 can be configured to occlude the tube 724, when the tube 724 is connected to the distal connector 902 and while the rotatable collar 706 is in the closed position. The clamp 1006 can include a first clamp member 1016 and a second clamp member 1018 provide an occlusion force on the tube 724 disposed between the first clamp member 1016 and the second clamp member 1018. As shown in FIG. 10, the tube 724 is not connected to the distal connector 902 allowing the clamp 1006 to be fully closed, with the first clamp member 1016 and the second clamp member 1018 directly interfacing with each other. For example, if the tube 724 was connected to the distal connector 902, the tube 724 would be occluded by being pinched in-between the first clamp member 1016 and the second clamp member 1018. If the rotatable collar 706 was rotated to an open position, as seen in FIGS 8A-8C, the first clamp member 1016 and the second clamp member 1018 would have a distance between them, such that a fluid could flow through the connected tube 724.

[0138] The rotatable collar 706 can, in some embodiments, include a mechanical stop 1104 that will prevent the rotatable collar 706 from rotating past the mechanical stop 1104. For example, when the rotatable collar 706 is rotated until the mechanical stop 1104 is hit, the rotatable collar 706 will not be able to be rotated any further. The mechanical stop 1104 is positioned along a shelf 1106 on the interior of the rotatable collar 706. In some embodiments, the body portion 716 can include a complimentary mechanical stop that will impact the mechanical stop 1104 on the rotatable collar 706 to prevent further rotation of the rotatable collar 706. In some embodiments, the rotatable collar 706 does not include a mechanical stop 1104 and is configured to rotate in either direction, a full 360-degree rotation. In some embodiments, the rotatable collar 706 is only permitted to rotated 90- degrees, in between the closed position and the open position, which are separated by a 90-Attorney Docket No. 218079.023201 (A0008816) degree rotation. To prevent further rotation, the mechanical stop 1104 can be included on the rotatable collar 706.

[0139] In some embodiments, the clamp assembly 704 can include a protrusion 1020 extending radially outward on the distal portion of the body portion 716. The protrusion 1020 is configured to, in some embodiments, mate with a complimentary cavity 1022 on the inner portion of the rotatable collar 706. The protrusion 1020 and the complimentary cavity 1022 can serve, in some embodiments, as the attachment mechanism to secure the clamp assembly 704 with the rotatable collar 706. When the protrusion 1020 of the clamp assembly 704 slides into the complimentary cavity 1022 on the rotatable collar 706, the clamp assembly 704 and rotatable collar 706 can be assembled. Because of the geometry of the complimentary cavity 1022 and the protrusion 1020, removing the clamp assembly 704 from the rotatable collar 706 can take a sufficient amount of force such that it would be difficult to separate the clamp assembly 704 from the rotatable collar 706 inadvertently.

[0140] Turning to FIG. 11, a portion of the rotatable collar 706 is shown. The rotatable collar 706 can, in some embodiments, include at least one socket 1102 configured to catch a complimentary rib 1202 extending from the body portion 716 of the clamp assembly 704. In some embodiments, the rotatable collar 706 can include four of the at least one socket 1102 to catch a position, i.e., the closed or open position, as the rotatable collar 706 is rotated. When a position is reached, the complimentary rib 1202 extending from the body portion 716 will flex into the at least one socket 1102, causing an audible noise. For example, the audible noise can be a ‘click’ type noise, which can alert the user that the rotation was successful in reaching the desired position. In some embodiments, the rotatable collar 706 can include a pair of bulges 1103 that are positioned on either side of each of the at least one socket 1102. The bulges 1103 function to prevent the rotatable collar 706 from rotating out of position inadvertently. For example, rotating the rotatable collar 706 out of the at least one socket 1102 requires the user to exert sufficient rotational force on the rotatable collar 706 to overcome the bulges 1103 that are on either side of the at least one socket 1102. The bulges 1103, then, function to maintain the position of the rotatable collar 706 relative to the clamp assembly 704. For example, when in a closed position, the bulges 1103 will prevent the rotatable collar 706 from rotating out of the closed position until the user exerts a sufficient force to overcome the bulges 1103.Attorney Docket No. 218079.023201 (A0008816)

[0141] In reference to FIG. 12, a portion of the clamp assembly 704 showing a portion of the body portion 716 is illustrated. As discussed above, as the rotatable collar 706 is rotated to a desired position, the at least one socket 1102 will, upon sufficient revolution, accept the complimentary rib 1202 disposed on the body portion 716. The body portion 716 can include a plurality of the complimentary rib 1202 or ribs, disposed on the exterior of the body portion 716. The complimentary rib 1202 can be configured to flex around the bulges 1103 and slide into place into the at least one socket 1102, as a user rotates the rotatable collar 706.

[0142] For example, as shown in FIG. 13, the complimentary rib 1202 are disposed within each of the at least one socket 1102. The clamp 1006 is shown in the open position, with a distance 1302 between the second clamp member 1018 and the first clamp member 1016 is sufficiently large to permit fluid flow through the tube 724 (not shown in FIG 13), which would be disposed between the first clamp member 1016 and the second clamp member 1018. In some embodiments, when in the closed position, the distance 1302 between the 1018 and the 1016 approaches 0. In some embodiments, when in the closed position, the distance 1302 between the 1018 and the 1016 approaches the thickness of the tube 724 disposed therebetween.

[0143] All prior patents and publications referenced herein are incorporated by reference in their entireties.

[0144] Throughout the specification and claims, the following terms take the meanings explicitly associated herein, unless the context clearly dictates otherwise. The phrases "in one embodiment," “in an embodiment,” and "in some embodiments" as used herein do not necessarily refer to the same embodiment(s), though it may. Furthermore, the phrases "in another embodiment" and "in some other embodiments" as used herein do not necessarily refer to a different embodiment, although it may. All embodiments of the disclosure are intended to be combinable without departing from the scope or spirit of the disclosure.

[0145] As used herein, the term "based on" is not exclusive and allows for being based on additional factors not described, unless the context clearly dictates otherwise. In addition, throughout the specification, the meaning of "a," "an," and "the" include plural references. The meaning of "in" includes "in" and "on."Attorney Docket No. 218079.023201 (A0008816)

[0146] As used herein, the term “between” does not necessarily require being disposed directly next to other elements. Generally, this term means a configuration where something is sandwiched by two or more other things. At the same time, the term “between” can describe something that is directly next to two opposing things. Accordingly, in any one or more of the embodiments disclosed herein, a particular structural component being disposed between two other structural elements can be: disposed directly between both of the two other structural elements such that the particular structural component is in direct contact with both of the two other structural elements; disposed directly next to only one of the two other structural elements such that the particular structural component is in direct contact with only one of the two other structural elements; disposed indirectly next to only one of the two other structural elements such that the particular structural component is not in direct contact with only one of the two other structural elements, and there is another element which juxtaposes the particular structural component and the one of the two other structural elements; disposed indirectly between both of the two other structural elements such that the particular structural component is not in direct contact with both of the two other structural elements, and other features can be disposed therebetween; or any combination(s) thereof.

Claims

Attorney Docket No. 218079.023201 (A0008816)CLAIMSWhat is claimed is:

1. A system comprising: a dialysis transfer set comprising: a tube; and a cap assembly connected to the tube, wherein the cap assembly comprises: a clamping member, wherein the clamping member comprises a clamp configured to engage the tube for enabling and disabling fluid flow through the tube; and a collar configured to move the clamp between a first position and a second position, wherein, when in the first position, the collar is configured to engage the clamp to disable fluid flow through the tube; wherein, when in the second position, the collar is configured to release the clamp to enable fluid flow through the tube.

2. The system of claim 1, wherein the clamping member comprises a first end and a second end opposite the first end; wherein the clamp is disposed at the second end of the clamping member.

3. The system of claim 2, wherein the clamping member further comprises: a connector,Attorney Docket No. 218079.023201 (A0008816) wherein the connector distally extends from the second end and is connectable with the tube, and a flow channel, wherein the flow channel extends from the first end of the clamping member to the connector.

4. The system of claim 1, wherein the clamping member further comprises: at least one groove, wherein the at least one groove circumferentially extends around an outer surface of the clamping member; and wherein the collar comprises: at least two pins, wherein the at least two pins are circumferentially located around an inner surface of the collar; wherein the at least two pins are configured to engage the at least one groove to retain a position of the collar relative the clamping member.

5. The system of claim 4, wherein the at least one groove comprises: a first groove, wherein the at least two pins are configured to engage the first groove to lock the clamp in the first position, and a second groove; wherein the at least two pins are configured to engage the second groove to lock the clamping member in the second position; wherein the first groove circumferentially extends around the clamping member between the second groove and the clamp.Attorney Docket No. 218079.023201 (A0008816)6. The system of claim 4, wherein the collar further comprises: one or more tab segments, wherein the one or more tab segments are configured to enable the collar to be positioned relative the clamping member so that the at least two pins engage the at least one groove to retain the position of the collar relative the clamping member.

7. The system of claim 1, wherein the clamp comprises: a first wing, and a second wing opposite the clamping member from the first wing, wherein the collar is configured to engage the first wing and the second wing to enable and disable the fluid flow through the tube.

8. The system of claim 1, wherein the collar comprises: a first portion, wherein the first portion comprises a first diameter, a second portion, wherein the second portion comprises a second diameter greater than the first diameter, and a third portion, wherein the third portion is located between the first portion and the second portion, wherein the third portion comprises a sloped transition extending between the first portion and the second portion.

9. The system of claim 8, wherein at least one of the first portion and the third portion adjacent the first portion engages the clamp to disable fluid flow through the tube;Attorney Docket No. 218079.023201 (A0008816) wherein at least one of the second portion and the third portion adjacent the second portion engages the clamping member to enable fluid flow through the tube.

10. The system of claim 1, wherein the cap assembly further comprises: a cap, wherein the cap is removably connected to the clamping member opposite the clamp, wherein the cap comprises at least one first thread configured to engage at least one second thread located on the clamping member to connect the cap to the clamping member.

11. A cap assembly for a dialysis transfer set, the cap assembly comprising: a clamping member comprising: a first end, a second end opposite the first end, a first groove, a second groove, and a clamp, wherein the clamp is configured to engage a tube for enabling and disabling fluid flow through the tube; a collar configured to move the clamping member between a first position and a second position, wherein, when in the first position, the collar is configured to engage the clamp to disable fluid flow through the tube; wherein, in the second position, the collar is configured to release the clamp to enable fluid flow through the tube; andAttorney Docket No. 218079.023201 (A0008816) a cap removably connected to the clamping member.

12. The cap assembly of claim 11, wherein the clamping member further comprising: a first wing, wherein the first wing is located at the first end, a second wing, wherein the second wing is located at the first end opposite the first wing on the clamping member, a connector, wherein the connector extends from the second end and is connectable with the tube, and a flow channel, wherein the flow channel extends from the first end of the clamping member to the connector; wherein the clamp comprises the first wing and the second wing; and wherein the collar is configured to engage the first wing and the second wing to enable and disable the fluid flow through the tube.

13. The cap assembly of claim 11, wherein the cap comprises: at least one first thread, wherein the at least one first thread is located on an inner surface of the cap; and wherein the clamping member further comprises: at least one second thread;Attorney Docket No. 218079.023201 (A0008816) wherein the at least one first thread of the cap is configured to engage the at least one second thread of the clamping member to removably connect the cap to the clamping member.

14. The cap assembly of claim 11, wherein the cap comprises: at least one recess, wherein the at least one recess longitudinally extends along an outer surface of the cap, wherein the at least one recess is configured to be engageable by a user to facilitate removably connecting the cap to the clamping member.

15. A transfer set assembly comprising: a tube; a clamping member including a first end and a second end opposite the first end, the clamping member comprising: a clamp, wherein the clamp comprises a plurality of wings, the plurality of wings being configured to engage the tube so as to control a fluid flow through the tube, and a connector, wherein the connector is located between the plurality of wings, the tube being installed on the connector; and a collar comprising: a circumferential inner surface, wherein a portion of the inner surface comprises a sloped transition having a tapered diameter, andAttorney Docket No. 218079.023201 (A0008816) wherein a position of the collar is movable between a plurality of positions in a circumferential direction relative the clamping member, and, in response to moving the collar between the plurality of positions, the collar engages the plurality of wings so as to control the fluid flow through the tube.

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