Sterile peritoneal dialysis transfer kit

Abstract

A peritoneal dialysis ("PD") transfer kit includes: a base having at least one slot; a slider extending within the base and including an elongated tube configured to carry PD fluid, the elongated tube extending to a head of the slider, the head including at least one lug extending through the at least one slot, and further including a connector for connection to a mating patient line connector; and a shroud barrel comprising at least one helical groove and extending around a portion of the base such that the at least one helical groove receives the at least one lug, where a user may rotate the shroud barrel comprising the at least one helical groove such that the shroud barrel extends around a portion of the base such that the at least one helical groove receives the at least one lug. The at least one lug extends along the at least one helical groove, and the at least one groove constrains movement of the at least one lug and the slider as translational movement.

Description

Technical Field

[0001] The present disclosure relates generally to medical fluid therapy, and in particular to peritoneal dialysis ("PD") therapy. Background Art

[0002] Due to various reasons, a person's renal system may fail. Kidney failure produces several physiological disturbances. It is no longer possible to balance water and minerals or to discharge the daily metabolic load. Toxic metabolic end products such as urea, creatinine, uric acid, etc. may accumulate in the patient's blood and tissues.

[0003] Dialysis is used to treat decreased kidney function and, most importantly, kidney failure. Dialysis removes waste products, toxins, and excess water from the body that normally functioning kidneys would otherwise remove. Dialysis treatment to replace kidney function is vital for many people because the treatment is life-saving.

[0004] One type of renal failure therapy is hemodialysis ("HD"), which typically uses diffusion to remove waste products from a patient's blood. A diffusion gradient occurs across a semipermeable dialyzer between the blood and an electrolyte solution called dialysate or dialysis fluid to induce diffusion.

[0005] Hemofiltration ("HF") is an alternative renal replacement therapy that relies on the convective transport of toxins from the patient's blood. HF is achieved by adding replacement or substitution fluid to an extracorporeal circuit during treatment. The replacement fluid and the patient's accumulated fluid between treatments are ultrafiltered during HF treatment, providing a convective transport mechanism that is particularly advantageous for the removal of middle and large molecules.

[0006] Hemodiafiltration ("HDF") is a treatment modality that combines convective and diffusive clearance. HDF uses a dialysis fluid that flows through a dialyzer (similar to standard hemodialysis) to provide diffusive clearance. In addition, a replacement solution is provided directly to the extracorporeal circuit, thereby providing convective clearance.

[0007] Most HD, HF and HDF treatments occur in centers. There is currently a trend toward home hemodialysis ("HHD"), in part because HHD can be performed every day, thereby providing treatment benefits that are superior to hemodialysis treatments in centers, which are usually performed every two weeks or three weeks. Studies have shown that more frequent treatments remove more toxins and wastes, and overload the dialysis room fluid less than patients who receive less frequent but potentially longer treatments. Patients who receive more frequent treatments do not experience as many down cycles (fluctuations of fluids and toxins) as patients in centers who have accumulated two or three days' worth of toxins before treatment. In some areas, the nearest dialysis center may be many miles away from the patient's home, resulting in door-to-door treatment time consuming most of the day. Treatment in a center close to the patient's home may also consume most of the patient's day. HHD can be performed at night or during the day while the patient is relaxing, working or otherwise producing.

[0008] Another type of renal failure therapy is peritoneal dialysis ("PD"), which infuses a dialysis solution (also called dialysis fluid or PD fluid) into the patient's peritoneal compartment via a catheter. The PD fluid contacts the peritoneum in the patient's peritoneal compartment. Waste products, toxins, and excess water flow from the patient's blood through the capillaries in the peritoneum and enter the PD fluid due to diffusion and osmosis, that is, an osmotic gradient occurs across the membrane. An osmotic agent in the PD fluid provides the osmotic gradient. The spent PD fluid is drained from the patient, thereby removing waste products, toxins, and excess water from the patient. The cycle is repeated, for example, multiple times.

[0009] There are various types of peritoneal dialysis therapies, including continuous ambulatory peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), tidal dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis treatment. Here, the patient manually connects an implanted catheter to a drain to allow spent PD fluid to drain from the patient's peritoneal cavity. The patient then switches the fluid connection so that the patient's catheter is connected to a bag of fresh PD fluid to inject fresh PD fluid into the patient through the catheter. The patient disconnects the catheter from the bag of fresh PD fluid and allows the PD fluid to dwell in the patient's peritoneal cavity, where transfer of waste, toxins, and excess water occurs. After the dwell period, the patient repeats the manual dialysis procedure, for example, four times a day. Manual peritoneal dialysis requires a significant amount of time and effort from the patient, leaving ample room for improvement.

[0010] APD is similar to CAPD in that dialysis treatment includes a drain, fill, and dwell cycle. However, an APD machine typically performs the cycle automatically while the patient sleeps. An APD machine saves the patient from having to manually perform treatment cycles and from having to transport supplies during the day. The APD machine is fluidly connected to an implanted catheter, to a source or bag of fresh PD fluid, and to a fluid drain. The APD machine pumps fresh PD fluid from a dialysis fluid source through the catheter and into the patient's peritoneal compartment. The APD machine also allows the PD fluid to dwell within the chamber and allows the transfer of waste, toxins, and excess water to occur. The source may include multiple liters of dialysis fluid that include several bags of solution.

[0011] The APD machine pumps used PD fluid from the patient's peritoneal cavity through a catheter to a drain. As with the manual process, several drain, fill, and dwell cycles occur during dialysis. The "last fill" may occur at the end of APD treatment. The final fill fluid may remain in the patient's peritoneal compartment until the next treatment begins, or may be manually emptied at some point during the day.

[0012] Both CAPD and APD patients are provided with a transfer set that is connected to the patient's indwelling catheter located within the patient's peritoneal cavity. The transfer set is connected to the patient's lines during treatment, which allows fresh PD fluid to be delivered to the patient and used PD fluid to be removed from the patient. Figure 1 1 shows a known transfer kit 110. The known transfer kit 110 includes a body 112 that is threadedly connected to a port adapter 114 at one end and threadedly connected to a sleeve 116 at an opposite end. The port adapter 114 is mated with a cap 118. The cap 118 is removed from the port adapter 114 to allow a patient line connector of a patient line (not shown) to be connected to the connecting end 114c of the port adapter 114 of the patient's transfer kit. The transfer kit line 120 extends from the hose barb end of the port adapter 114 to the patient's indwelling catheter (not shown).

[0013] The patient line connector is a male Luer connector, while the connection end 114c of the port adapter 114 as shown is a female Luer connector. The connection between the male Luer patient line connector and the female Luer connection end 114c is the main source of touch contamination. Touch contamination is one of the main causes of peritonitis. Peritonitis is the most common infection and cause of failure of PD technology. Peritonitis is the leading reason for PD patients to drop out in the first 90 to 120 days of treatment. Therefore, there is a need for an improved PD transfer kit that reduces the possibility of touch contamination (particularly at the connection interface between the male Luer patient line connector and the female Luer connection end 114c of the port adapter 114). Summary of the invention

[0014] The present disclosure describes an improved peritoneal dialysis ("PD") transfer kit. The PD transfer kit in one embodiment includes four components, namely a base, a slider, a shield tube, and a microcap. Any one or more or all of the components of the transfer kit can be formed (e.g., molded) from a thermoplastic such as polyetherimide ("PEI"), polyethersulfone ("PES"), polyamide / nylon ("PA"), acrylonitrile butadiene styrene ("ABS"), polycarbonate ("PC"), polyvinyl chloride ("PVC"), or polyetheretherketone ("PEEK").

[0015] The base includes a larger diameter cylindrical portion that is oriented toward the patient during use. In one embodiment, the larger diameter cylindrical portion is provided with serrations so that a user such as a patient grasps the cylindrical portion and manipulates the transfer kit. The larger diameter cylindrical portion is open at its outer end oriented toward the patient and allows a flexible conduit (e.g., a silicone conduit) to extend from the patient's indwelling catheter into the transfer kit. The larger diameter cylindrical portion includes a circular washer-shaped flange wall at its other end that extends inwardly from the larger diameter portion to a central hole or opening. A port having an inner diameter that is the same as or may be slightly larger than the diameter of the hole extends at least partially through the larger diameter portion and extends within the larger diameter portion. In one embodiment, the size of the port as shown herein is designed to receive an extension tube of a slider. The size of the outer diameter of the extension tube of the slider can be set so that a conduit (e.g., a silicone conduit) extending from the patient's indwelling catheter is sealed on the outside of the extension tube of the slider.

[0016] The base also includes a tubular portion extending from (e.g., formed together with) the larger diameter cylindrical portion. The tubular portion extends from the circular washer-shaped flange wall in a direction opposite to the port. In one embodiment, the tubular portion of the base is formed to have a smaller diameter than the larger diameter cylindrical portion and a larger diameter than the port. In one embodiment, the length of the tubular portion of the base is large enough to accept the sliding motion of the head of the slider. To this end, the tubular portion of the base is provided with at least one (and in one embodiment two) straight through slots extending straight through the wall of the tubular portion. The straight through slots are sized to receive lugs, e.g., one lug for each slot, wherein the lugs extend outwardly from the head of the slider. In one embodiment, the base including the tubular portion and the slider does not rotate during actuation. Instead, the slider including the lugs slides along the base, wherein the through slots provide a translational motion guide for the slider.

[0017] In addition to the through slots of the tubular portion, the ports of the base also serve as guides for the movement of the slider. The ports receive the elongated tube of the slider and radially constrain the elongated tube as it slides within the ports during actuation.

[0018] In one embodiment, the circulator end of the tubular portion of the base of the transfer kit is provided with female threads that threadably engage with the male threads of the micro-cap. The micro-cap seals the interior of the transfer kit during sterilization, transportation, and storage prior to use. In one embodiment, the micro-cap is removed and discarded to connect the transfer kit for treatment.

[0019] In one embodiment, a slider of a transfer kit as described herein includes an elongated tube extending to the head of the slider. The diameter of the elongated tube is sized to fit relatively tightly within a port of the base of the transfer kit and sealingly mate within a flexible tubing extending from a patient's indwelling catheter. Although not shown, one end of the elongated tube may be formed with a connector, such as a Luer-type connector, that mates with a connector, such as a Luer-type connector, disposed at one end of the flexible tubing extending from the patient's indwelling catheter. The larger diameter cylindrical portion of the base is large enough to accommodate the mating connectors of the elongated tube and indwelling catheter tubing (if provided).

[0020] The head of the slider includes an inner portion having a female Luer connector including male threads and a tapered female inner wall. In one embodiment, the female Luer connector is sized to mate with a standard male Luer, which is a standard patient line connector located at one end of a patient line extending from, for example, a PD machine or circulator. The male Luer connector of the patient line connector includes female threads that mate with the male threads of the female Luer connector of the head of the slider. The male Luer connector also includes a tapered port that sealingly engages the tapered female inner wall of the female Luer connector of the head of the slider.

[0021] The head of the slider includes a transverse wall extending outwardly from an inner portion of the head. The transverse wall extends to an outer cylindrical wall of the slider head. In one embodiment, the transverse wall, cylindrical wall and inner portion of the slider head are formed (e.g., molded) as a single piece with the elongated tube of the slider. The radial length of the transverse wall and the outer diameter of the cylindrical wall are sized so that the cylindrical wall fits relatively tightly within the inner surface of the tubular portion of the base.

[0022] The one or more lugs (e.g., two lugs at 180° to each other) extend from the outer surface of the cylindrical wall of the head of the slider. The diameter of the at least one lug is sized to fit tightly within the straight through slot of the tubular portion of the base. The height of the at least one lug is sized to extend straight through the at least one straight through slot of the tubular portion of the base, sufficient to extend into at least one spiral groove of the shield barrel. As shown, the position of the transverse wall extending to the middle portion of the cylindrical wall of the head of the slider enables the cylindrical wall to flex. The flexure of the cylindrical wall enables the at least one lug to snap fit into the matching at least one through slot of the tubular portion of the base during manufacturing. After the at least one lug is snap-fitted into the matching at least one through slot, the slider is slidably constrained within the base of the transfer kit.

[0023] The shield tube as shown is positioned substantially around the outside of the tubular portion of the base. The shield tube is formed to define at least one impermeable spiral groove, and in one embodiment, the impermeable spiral groove extends at least twenty millimeters, such as twenty-four millimeters (about one inch) around the inner surface of the shield tube. One end of the at least one lug of the slider extends into the at least one impermeable spiral groove of the shield tube. In the illustrated embodiment, the spiral groove is impermeable and does not extend all the way through the wall of the shield tube, which allows the shield tube to better provide a sterile barrier against touch contamination. However, it should be understood that the at least one spiral groove does not have to be impermeable, and if the at least one spiral groove instead extends all the way through the wall of the shield tube, the movement of the slider during actuation will operate as described.

[0024] In one embodiment, the at least one non-penetrating spiral groove is oriented such that: when the user or patient rotates the shield barrel in a clockwise direction, the slider is translated forward so that the female Luer connector of the head of the slider extends toward the connection position with the male Luer connector of the patient line connector. Similarly, when the user or patient rotates the shield barrel in a counterclockwise direction, the slider is translated backward so that the female Luer connector of the head of the slider is retracted from the connection position. In an alternative embodiment, the orientation is reversed so that counterclockwise rotation causes the slider to translate toward the connection position, and clockwise rotation causes the slider to translate away from the connection position.

[0025] In one embodiment, the base of the transfer kit of the present disclosure does not move during activation (or reverse activation). The serrations of the larger diameter cylindrical portion of the base provide a convenient position for the user or patient to stably grasp and hold the transfer kit. The slider translates relative to the base during activation (or reverse activation). The shield tube is rotated relative to the base by the other hand of the user or patient. If the tubular portion of the base is not provided, the rotation of the shield tube will simply rotate the at least one engaged lug and the rest of the slider, and no translation will occur. However, as the at least one engaged lug moves through the at least one corresponding spiral groove of the rotation, the at least one straight through slot of the tubular portion of the base prevents the slider from rotating and instead forces the slider to translate.

[0026] In accordance with the disclosure set forth herein, and without limiting the disclosure in any way, in a first aspect of the disclosure, which may be combined with any other aspect or portion thereof, a peritoneal dialysis (“PD”) transfer kit comprises: a base comprising at least one slot; a slider extending within the base, the slider comprising an elongated tube configured to carry PD fluid, the elongated tube extending to a head of the slider, the head comprising at least one lug extending through the at least one slot, the head further comprising a connector for connecting to a matching patient line connector; and a shield barrel comprising at least one spiral groove, the shield barrel extending around a portion of the base such that the at least one spiral groove receives the at least one lug, wherein a user can rotate the shield barrel comprising the at least one spiral groove such that the at least one lug extends along the at least one spiral groove, the at least one groove constraining movement of the at least one lug and the slider to translational motion.

[0027] In a second aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the base includes a larger diameter cylindrical portion configured to be gripped by the user while the user rotates the shield tube, and the base also includes a tubular portion defining the at least one groove.

[0028] In a third aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the base includes a port within the larger diameter cylindrical portion, the port being in fluid communication with the elongated tube, the port being positioned and arranged to be in fluid communication with a patient catheter tubing.

[0029] In a fourth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, one end of the tubular portion is provided with threads for matching with threads of a cap configured to seal the transfer kit prior to treatment.

[0030] In a fifth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, an inner diameter of the tubular portion is sized to fit closely around the head of the slider.

[0031] In a sixth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the tubular portion of the base and the shield barrel are positioned and arranged to prevent touch contamination of the connection between the slider connector and the patient line connector.

[0032] In a seventh aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the at least one groove is a straight groove.

[0033] In an eighth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the connector of the slider is a Luer connector.

[0034] In a ninth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the slider comprises an inner portion, a transverse wall extending from the inner portion to a cylindrical wall, the inner portion providing the connector, and the at least one lug extending from the cylindrical wall.

[0035] In a tenth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the shroud tube extends around a tubular portion of the base.

[0036] In an eleventh aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the at least one spiral groove is at least one spiral groove that does not penetrate.

[0037] In a twelfth aspect of the present disclosure which may be combined with any other aspect or a portion thereof, the at least one spiral groove is formed on an inner surface of the shroud barrel.

[0038] In a thirteenth aspect of the present disclosure that may be combined with any other aspect or a portion thereof, the at least one spiral groove extends at least twenty millimeters along the shroud barrel.

[0039] In a fourteenth aspect of the present disclosure that may be combined with any other aspect or a portion thereof, the PD transfer kit is configured such that one end of the at least one spiral groove is positioned and arranged to allow the connector of the slider to interface with the patient line connector, and wherein further rotation of the shield cylinder screws the patient line connector into the connector of the slider.

[0040] In the fifteenth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PD transfer kit is configured such that one end of the at least one spiral groove is positioned and arranged to allow the connector of the slider to connect with the patient line connector, and wherein rotating the patient line connector screws the patient line connector into the connector of the slider.

[0041] In a sixteenth aspect of the present disclosure that may be combined with any other aspect or a portion thereof, the PD transfer kit is configured such that: rotating the shield tube in a first direction causes the connector of the slider to translate toward the patient line connector, and rotating the shield tube in a second direction causes the connector of the slider to translate away from the patient line connector.

[0042] In a seventeenth aspect of the present disclosure that may be combined with any other aspect or a portion thereof, a peritoneal dialysis ("PD") transfer kit comprises: a base comprising at least one slot; a slider extending within the base, the slider being configured to carry PD fluid, the slider comprising at least one lug and a connector, the at least one lug extending through the at least one slot, the connector being used to connect to a matching patient line connector; and a shield barrel comprising at least one spiral groove, the shield barrel extending around a portion of the base such that the at least one spiral groove receives the at least one lug, wherein a user can rotate the shield barrel comprising the at least one spiral groove such that the at least one lug extends along the at least one spiral groove, the at least one groove constraining movement of the at least one lug and the slider to translational motion, and wherein rotating the shield barrel in a first direction translates the connector of the slider toward the patient line connector, and rotating the shield barrel in a second direction translates the connector of the slider away from the patient line connector.

[0043] In an eighteenth aspect of the present disclosure that may be combined with any other aspect or a portion thereof, the at least one spiral groove comprises at least one circular protrusion positioned and arranged to provide a temporary stop that releasably maintains the at least one lug and the slider in a position toward or away from the patient line connector.

[0044] In a nineteenth aspect of the present disclosure that may be combined with any other aspect or a portion thereof, a peritoneal dialysis ("PD") connection method includes: providing a shield barrel, the shield barrel comprising at least one spiral groove; providing a tubular portion, the tubular portion comprising at least one slot; providing a connector through which PD fluid flows, the connector comprising at least one lug, the at least one lug extending through the at least one slot and extending into the at least one spiral groove; and enabling the shield barrel to be rotated to rotate the at least one spiral groove so as to cause movement of the at least one lug and the connector, and wherein the at least one slot constrains the movement of the at least one lug and the connector to translational movement of the connector toward a mating connector for connection or away from the mating connector after disconnection.

[0045] In the twentieth aspect of the present disclosure, which may be combined with any other aspect or a portion thereof, the PD connection method includes enabling the shield tube to be: rotated in a first direction to translate the connector toward the mating connector for connection, and rotated in a second direction to translate the connector away from the mating connector after disconnection.

[0046] In a twenty-first aspect of the present disclosure that may be combined with any other aspect or a portion thereof, Figures 2 to 11 Any one or more of the features, functions and alternatives described in any one or more of the above may be combined with Figures 2 to 11 Any feature, function and alternative combination described in any other figure in the.

[0047]

[0013] In accordance with the above aspects and the disclosure set forth herein, an advantage of the present disclosure is to provide an improved peritoneal dialysis ("PD") transfer kit.

[0048] Another advantage of the present disclosure is to provide an improved PD transfer kit that reduces touch contamination.

[0049] Another advantage of the present disclosure is to provide an improved PD transfer kit that reduces the risk of peritonitis.

[0050] Yet another advantage of the present disclosure is to provide an improved PD transfer set that facilitates fluid transfer in a more sterile environment at the patient connection end of the transfer set that is isolated from external contaminants.

[0051] Additional features and advantages are described in and will be apparent from the following detailed description and accompanying drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the accompanying drawings and description. Moreover, it is not necessary for any particular embodiment to have all of the advantages listed herein, and it is expressly contemplated that each beneficial embodiment is separately claimed. Furthermore, it should be noted that the language used in this specification has been selected primarily for readability and instructional purposes, rather than to limit the scope of the subject matter of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Figure 1 is a cut-away perspective view of a prior art peritoneal dialysis ("PD") transfer kit.

[0053] Figure 2 is a cut-away elevation view of one embodiment of a PD transfer kit of the present disclosure with the slider retracted within the base and shroud barrel of the transfer kit.

[0054] Figure 3 is a cut-away perspective view of one embodiment of a PD transfer kit of the present disclosure with a slider extending within a base and shield barrel of the transfer kit for connection to a patient line connector.

[0055] Figure 4 is a cut-away perspective view of one embodiment of a PD transfer kit of the present disclosure showing the lugs of the slider extending through the slots of the base and into the grooves of the shield barrel.

[0056] Figure 5 is a perspective view of one embodiment of a base of a PD transfer kit of the present disclosure.

[0057] Figure 6 A perspective view of one embodiment of a portion of a slider of a PD transfer kit of the present disclosure.

[0058] Figure 7 and Figure 8 1 and 2 are a perspective view and a cutaway perspective view, respectively, of one embodiment of a shield cylinder of a PD transfer kit of the present disclosure.

[0059] Fig. 9 is a cut-away elevation view of one embodiment of a PD transfer kit of the present disclosure with a patient line connector connected to the transfer kit.

[0060] Fig.10 is a cut-away elevation view of one embodiment of a PD transfer set of the present disclosure, wherein PD fluid flows through the transfer set between a PD machine or cycler and a patient.

[0061] Fig.11is a cut-away elevation view of one embodiment of a PD transfer kit of the present disclosure with the patient line connector removed from the transfer kit. DETAILED DESCRIPTION

[0062] Referring again to the drawings, and in particular to Figures 2 to 11 , an improved peritoneal dialysis ("PD") transfer kit 10 is provided. The PD transfer kit 10 in one embodiment includes four components, namely a base 20, a slider 50, a shield cylinder 80, and a microcap 90. Any one or more or all of the components of the transfer kit 10 can be formed (e.g., molded) from a thermoplastic such as polyetherimide ("PEI"), polyethersulfone ("PES"), polyamide / nylon ("PA"), acrylonitrile butadiene styrene ("ABS"), polycarbonate ("PC"), polyvinyl chloride ("PVC"), or polyetheretherketone ("PEEK").

[0063] Figure 2 , Figure 3 , Figure 4 , Figure 5 and Figures 9 to 11 The base 20 is shown. The base 20 includes a larger diameter cylindrical portion 22 that is oriented toward the patient during use. In one embodiment, the larger diameter cylindrical portion 22 is provided with serrations 24 to facilitate a user, such as a patient, to grasp the cylindrical portion 22 and manipulate the transfer kit 10. The larger diameter cylindrical portion 22 is open at its outer end 26 that is oriented toward the patient and allows a flexible tubing, such as silicone tubing 12 (see FIG. 1 ). Fig.10 ) extends from the patient's indwelling catheter into the transfer kit 10. The larger diameter cylindrical portion 22 includes a circular washer-shaped flange wall 30 at its other end 28, which extends inwardly from the larger diameter portion to a central hole or opening 32. A port 34 having an inner diameter that is the same as or possibly slightly larger than the diameter of the hole extends at least partially through and within the larger diameter portion 22. In one embodiment, the port 34 as shown herein is sized to receive the extension tube 52 of the slider 50. The outer diameter of the extension tube 52 of the slider 50 can be sized so that the tubing 12 (e.g., silicone tubing) extending from the patient's indwelling catheter seals against the outside of the extension tube 52 of the slider 50 (see Fig.10 ).

[0064] The base 20 also includes a tubular portion 36 that extends from (e.g., is formed together with) the larger diameter cylindrical portion 22. The tubular portion 36 extends from the circular washer-shaped flange wall 30 in a direction opposite to the port 34. In one embodiment, the tubular portion 36 of the base 20 is formed to have a smaller diameter than the larger diameter cylindrical portion 22 and a larger diameter than the port 34. In one embodiment, the length of the tubular portion 36 of the base 20 is large enough to accept the sliding movement of the head of the slider 50. To this end, the tubular portion 36 of the base 20 is provided with at least one (and in one embodiment, two) straight through slots 38 ( Figure 2 , Figure 5 and Figures 9 to 11 ), the straight slot 38 extends all the way through the wall of the tubular portion. The straight slot 38 is sized to receive the lug 68 ( Figure 4 , Figure 6 ), for example, one lug for each slot, wherein lugs 68 extend outwardly from head 54 of slider 50. In one embodiment, base 20 including tubular portion 36 and slider 50 does not rotate during actuation. Instead, slider 50 including lugs 68 slides along base 20, wherein through slot 38 provides a translational motion guide for slider 50.

[0065] In addition to the slot 38 of the tubular portion 36, the port 34 of the base 20 also serves as a guide for the movement of the slider 50. The port 34 receives the elongated tube 52 of the slider 50 and radially constrains the elongated tube as it slides within the port during actuation.

[0066] In one embodiment, the circulator end 40 of the tubular portion 36 of the base 20 of the transfer kit 10 is provided with a female thread 42 that is threadedly engaged with the male thread 92 of the microcap 90. The microcap 90 seals the interior of the transfer kit 10 during sterilization, transportation, and storage prior to use. In one embodiment, the microcap 90 is removed and discarded to connect the transfer kit 10 for treatment. When the patient line is removed, a new microcap 90 can be replaced after treatment, wherein the threads 92 of the new microcap are coated or covered with a disinfectant.

[0067] Figure 2 , Figure 3 , Figure 4 , Figure 6 and Figures 9 to 11 Slider 50 is shown. In one embodiment, slider 50 of transfer kit 10 as described herein includes an elongated tube 52 extending to a head 54 of slider 50. The diameter of elongated tube 52 is sized to fit relatively tightly within port 34 of base 20 of transfer kit 10 and to sealingly fit within flexible tubing 12 ( Fig.10). Although not shown, one end of the extension tube 52 may be formed with a connector, such as a Luer-type connector, which mates with a connector, such as a Luer-type connector, provided at one end of the flexible tubing 12 extending from the patient's indwelling catheter. The larger diameter cylindrical portion 22 of the base 20 as shown is large enough to receive the mating connectors of the extension tube 52 and the indwelling catheter tubing 12 (if provided).

[0068] The head 54 of the slider 50 includes an inner portion 56 having a female Luer connector 60 including male threads 62 and a tapered female inner wall 64 ( Figure 2 , Figure 3 , Figure 6 In one embodiment, the female Luer connector 60 is sized to fit the standard male Luer connector 18 ( Figures 9 to 11 ) mating, a standard male Luer connector 18 is located, for example, from a PD machine or circulator 14 ( Fig.10 ) at one end of a patient line 16 extending from the transfer kit 10. The male Luer connector 18 includes female threads 18f that mate with the male threads 62 of the female Luer connector 60 of the head 54 of the slider 50. The male Luer connector 18 also includes a tapered port 18p that sealingly engages a tapered female inner wall 64 of the female Luer connector 60 of the head 54 of the slider 50 to create a fluid-tight connection between the transfer kit 10 and the patient line connector 18. In alternative embodiments, the connection between the transfer kit 10 and the patient line connector 18 may be a connection other than a Luer connection, such as a different type of threaded connection, and / or may involve the use of a compressible gasket.

[0069] The head 54 of the slider 50 includes a transverse wall 58 extending outwardly from the inner portion 56 of the head 54. The transverse wall 58 extends to the outer cylindrical wall 66 of the head 54 of the slider 50. In one embodiment, the transverse wall 58, the cylindrical wall 66 and the inner portion of the head 54 of the slider 50 are formed (e.g., molded) as a single piece with the elongated tube 52 of the slider 50. In one embodiment, the radial length of the transverse wall 58 and the outer diameter of the cylindrical wall 66 are sized so that the cylindrical wall 66 fits relatively tightly within the inner surface of the tubular portion 36 of the base 20.

[0070] The one or more lugs 68 ( Figure 4 and Figure 6) (e.g., two lugs 68 positioned 180° from each other) extend from the outer surface of the cylindrical wall 66 of the head 54 of the slider 50. The lugs 68 may be formed with the cylindrical wall 66 or attached to the cylindrical wall 66, such as being threadedly connected to the cylindrical wall 66. The diameter of the at least one lug 68 is sized to fit tightly within the straight through slot 38 of the tubular portion 36 of the base 20. The height of the at least one lug 68 is sized to extend all the way through the at least one straight through slot 38 of the tubular portion 36 of the base 20, sufficient to extend into the at least one spiral groove 82 of the shield barrel 80. As shown, the position of the transverse wall 58 extending to the middle portion 66m of the cylindrical wall 66 of the head 54 of the slider 50 enables the cylindrical wall to flex. The flexure of the cylindrical wall 66 enables the at least one lug 68 to snap fit within the matching at least one through slot 38 of the tubular portion 36 of the base 20 during manufacturing. After snap-fitting the at least one lug 68 into the matching at least one through slot 38, the slider 50 is slidingly restrained within the base 20 of the transfer kit 10. In one embodiment, the at least one lug 68 is spring-loaded so that it can be compressed during manufacturing and then snapped through the at least one slot 38 and / or the at least one spiral groove 82.

[0071] Figure 2 , Figure 3 , Figure 4 and Figures 7 to 11 Shown is a shield tube 80. The shield tube 80 as shown is positioned substantially around the outside of the tubular portion 36 of the base 20. The shield tube 80 is formed to define at least one impermeable spiral groove 82, and in one embodiment, the impermeable spiral groove 82 extends at least twenty millimeters, such as twenty-four millimeters (about one inch) around the inner surface of the shield tube. One end of at least one lug 68 of the slider 50 extends into the corresponding at least one impermeable spiral groove 82 of the shield tube 80. In the illustrated embodiment, the spiral groove 82 is impermeable and does not extend through the wall of the shield tube 80, which allows the shield tube to better provide a sterile barrier against touch contamination. However, it should be understood that at least one spiral groove 82 does not have to be impermeable, and if the at least one spiral groove instead extends through the wall of the shield tube 80, the movement of the slider 50 during actuation will operate as described.

[0072] In one embodiment, the at least one non-penetrating spiral groove 82 is oriented such that: when the user or patient rotates the shield barrel 80 in a clockwise direction, the slider 50 is translated forward, so that the female Luer connector 60 of the head 54 of the slider 50 extends toward a connection position with the male Luer connector 18 as a patient line connector. Likewise, when the user or patient rotates the shield barrel 80 in a counterclockwise direction, the slider 50 is translated backward, so that the female Luer connector 60 of the head 54 of the slider 50 is retracted from the connection position. In an alternative embodiment, the orientation is reversed so that counterclockwise rotation causes the slider to translate toward the connection position, and clockwise rotation causes the slider to translate away from the connection position.

[0073] Figure 8 It is also shown that each non-penetrating spiral groove 82 may include or define at least one ridge or semicircular protrusion 82b that extends inwardly into the spiral groove. The at least one ridge or semicircular protrusion 82b helps initiate the translational movement of the corresponding lug 68 and provides a smooth slope / rounded corner for the lug. The at least one ridge or semicircular protrusion 82b located at each end of the spiral groove 82 also serves as a temporary stop or locking feature to releasably maintain the corresponding lug 68 and the slider 50 in the fully extended and fully retracted positions discussed below.

[0074] In one embodiment, the base 20 of the transfer kit 10 of the present disclosure does not move during activation (or deactivation). The serrations 24 of the larger diameter cylindrical portion 22 of the base 20 provide a convenient location for the user or patient to stably grasp and hold the transfer kit 10. The slider 50 translates relative to the base 20 during activation (or deactivation). The shield barrel 80 is rotated relative to the base 20 by the other hand of the user or patient. If the tubular portion 36 of the base 20 is not provided, the rotation of the shield barrel 80 will simply rotate the at least one engaged lug 68 and the rest of the slider 50, and no translation will occur. However, as the at least one engaged lug 68 moves through the at least one corresponding spiral groove 82 of the rotation, the at least one straight through slot 38 of the tubular portion 36 of the base 20 prevents the slider 50 from rotating and instead forces the slider 50 to translate.

[0075] Figure 2 A first connection step is shown in which a user or patient removes (e.g., loosens) the micro cap 90 (or other cap) from the female threads 42 of the base 20. Figure 2 , the slider 50 is in the fully retracted position. Fig. 9A second connection step is shown in which the user or patient turns or rotates the shield barrel 80 (e.g., in a clockwise direction), thereby moving the at least one lug 68 and slider 50 along the at least one helical groove 82, wherein the straight groove 38 of the base constrains the movement of the slider 50 to sliding or translational movement. Fig. 9 , the slider is translated to the fully extended end of at least one spiral groove 82, where it is able to mate with the patient connector 18. Here, the user can (i) continue to rotate the shield barrel 80 to screw the male luer connector 18 onto the female luer connector 60 of the slider 50; (ii) rotate the male luer connector 18 to screw the male luer connector 18 onto the female luer connector 60 of the slider 50; or (iii) rotate both the shield barrel 80 and the male luer connector 18 to screw the male luer connector 18 onto the female luer connector 60 of the slider 50. In any case, in Fig.10 When the male Luer connector 18 is fully sealed to the female Luer connector 60, treatment can be performed with fresh and used PD fluid traveling back and forth between the PD machine 14 and the patient via the transfer kit 10. Fig.11 In the disconnection step in FIG. 1 , after treatment, the user or patient removes (loosens) the male Luer connector 18 from the female Luer connector 60 of the slider 50 and rotates the shield cylinder 80 in the opposite direction (e.g., counterclockwise) to return the slider to the Figure 2 The user or patient can then screw a new micro-cap with disinfectant into the threads 42 of the base 20 .

[0076] It should be understood that during the above-described connection and disconnection steps, the mating surfaces of the male and female luer connectors 18, 60 are protected from touch contamination by both the tubular portion 36 of the base 20 and the shield barrel 80. The female luer connector 60 is constantly maintained within the tubular portion 36 of the base 20 and the shield barrel 80.

[0077] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. It is therefore intended that any or all such changes and modifications may be covered by the appended claims. For example, while a transfer kit 10 is shown that shows the slider 50 having a female Luer connector 60 and the patient connector 18 being a male Luer connector, the opposite may alternatively be provided, wherein the slider 50 provides a male Luer connector and the patient connector 18 is a female Luer connector. Furthermore, the cap 90 may be any suitable cap and need not be a micro cap.

Claims

1. A peritoneal dialysis ("PD") transfer kit comprising: a base, the base comprising at least one groove; a slider extending within the base, the slider including an elongated tube configured to carry PD fluid, the elongated tube extending to a head of the slider, the head including at least one lug extending through the at least one slot, the head further including a connector for connecting to a mating patient line connector; and A shield cylinder comprising at least one spiral groove, the shield cylinder extending around a portion of the base so that the at least one spiral groove receives the at least one lug, wherein a user is able to rotate the shield cylinder comprising the at least one spiral groove so that the at least one lug extends along the at least one spiral groove, and the at least one groove constrains the movement of the at least one lug and the slider to a translational movement.

2. The PD transfer kit according to claim 1, wherein: The base includes a larger diameter cylindrical portion configured for gripping by a user while the user rotates the shield cylinder, and a tubular portion defining the at least one slot.

3. The PD transfer kit according to claim 2, wherein: The base includes a port within the larger diameter cylindrical portion, the port being in fluid communication with the elongated tube, the port being positioned and arranged to be in fluid communication with a patient catheter conduit.

4. The PD transfer kit according to claim 2, wherein: One end of the tubular portion is provided with threads for mating with threads of a cap configured to seal the transfer kit prior to treatment.

5. The PD transfer kit according to claim 2, wherein: The inner diameter of the tubular portion is sized to fit closely around the head of the slider.

6. The PD transfer kit according to claim 2, wherein: The tubular portion of the base and the shroud barrel are positioned and arranged to prevent touch contamination of the connection between the slider connector and the patient line connector.

7. The PD transfer kit according to claim 1, wherein: The at least one slot is a straight slot.

8. The PD transfer kit according to claim 1, wherein: The connector of the slider is a Luer connector.

9. The PD transfer kit according to claim 1, wherein: The slider comprises an inner portion providing the connector, a transverse wall extending from the inner portion to a cylindrical wall from which the at least one lug extends.

10. The PD transfer kit according to claim 1, wherein: The shroud tube extends around the tubular portion of the base.

11. The PD transfer kit according to claim 1, wherein: The at least one spiral groove is at least one spiral groove that does not penetrate.

12. The PD transfer kit according to claim 1, wherein: The at least one helical groove is formed on an inner surface of the shroud barrel.

13. The PD transfer kit according to claim 1, wherein: The at least one spiral groove extends at least twenty millimeters along the shroud barrel.

14. The PD transfer kit of claim 1, the PD transfer kit being configured such that one end of the at least one spiral groove is positioned and arranged to allow the connector of the slider to interface with the patient line connector, and wherein, Further rotation of the shield barrel threads the patient line connector into the connector of the slider.

15. The PD transfer kit of claim 1, the PD transfer kit being configured such that one end of the at least one spiral groove is positioned and arranged to allow the connector of the slider to interface with the patient line connector, and wherein, Rotating the patient line connector threads the patient line connector into the connector of the slider.

16. The PD transfer kit of claim 1, wherein the PD transfer kit is configured such that: rotating the shield tube in a first direction causes the connector of the slider to translate toward the patient line connector, and rotating the shield tube in a second direction causes the connector of the slider to translate away from the patient line connector.

17. A peritoneal dialysis ("PD") transfer kit comprising: a base, the base comprising at least one groove; a slider extending within the base, the slider being configured to carry PD fluid, the slider comprising at least one lug extending through the at least one slot and a connector for connecting to a mating patient line connector; and A shield cylinder comprising at least one spiral groove, the shield cylinder extending around a portion of the base so that the at least one spiral groove receives the at least one lug, wherein a user is able to rotate the shield cylinder comprising the at least one spiral groove so that the at least one lug extends along the at least one spiral groove, the at least one groove constrains movement of the at least one lug and the slider to translational movement, and wherein rotating the shield cylinder in a first direction translates the connector of the slider toward the patient line connector, and rotating the shield cylinder in a second direction translates the connector of the slider away from the patient line connector.

18. The PD transfer kit according to claim 17, wherein: The at least one helical groove includes at least one circular protrusion positioned and arranged to provide a temporary stop that releasably maintains the at least one lug and slider in a position toward or away from the patient line connector.

19. A peritoneal dialysis ("PD") connection method, comprising: providing a shield barrel, the shield barrel comprising at least one spiral groove; providing a tubular portion, the tubular portion comprising at least one slot; providing a connector, wherein PD fluid flows through the connector, the connector comprising at least one lug extending through the at least one slot and into the at least one spiral groove; and The shield barrel is enabled to be rotated to rotate the at least one spiral groove to cause movement of the at least one lug and the connector, and wherein the at least one groove constrains the movement of the at least one lug and the connector to translational movement of the connector toward a mating connector for connection or away from the mating connector after disconnection.

20. The PD connection method of claim 19, comprising enabling the shield cylinder to be rotated in a first direction to translate the connector toward a mating connector for connection and rotated in a second direction to translate the connector away from the mating connector after disconnection.

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