Sterile peritoneal dialysis transfer set

Abstract

A peritoneal dialysis ("PD") transfer set includes a base having at least one slot, a slider including an elongated tube extending into the base and configured to carry PD fluid, the elongated tube extending to a head of the slider, the head including at least one protrusion extending through the at least one slot and further including a connector for connecting to a mating patient line connector, and a shroud barrel including at least one spiral groove and extending around a portion of the base such that the at least one spiral groove receives the at least one protrusion, wherein a user can rotate the shroud barrel including the at least one spiral groove such that the at least one protrusion extends along the at least one spiral groove, and the at least one slot constrains movement of the at least one protrusion and the slider to be translational.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical fluid therapy, and more particularly to peritoneal dialysis ("PD") therapy. [Background technology]

[0002] Due to a variety of causes, a person's renal system can fail. Renal failure results in several physiological disorders: it is no longer possible to balance water and minerals or excrete the daily metabolic load. Toxic end products of metabolism, such as urea, creatinine, uric acid, and others, can accumulate in the patient's blood and tissues.

[0003]

[0003] Declining kidney function, particularly kidney failure, is treated using dialysis. Dialysis removes waste products, toxins, and excess water from the body that normally functioning kidneys would remove. Dialysis treatment for kidney function replacement is vital for many people because this treatment is lifesaving.

[0004] One type of renal failure therapy is hemodialysis ("HD"), which generally 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 dialysate, causing diffusion.

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

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

[0007] Most HD, HF, and HDF treatments occur in facilities. There is a trend today toward home hemodialysis ("HHD"), in part because HHD can be performed daily, offering therapeutic benefits over in-center hemodialysis treatments, which typically occur twice or three times a week. Research has shown that more frequent treatments remove more toxins and waste products and are less susceptible to interdialytic fluid overload than patients receiving less frequent but potentially longer treatments. Patients receiving more frequent treatments do not experience as much downcycling (fluid and toxin fluctuations) as in-center patients who accumulate two or three days' worth of toxins before treatment. In some areas, the nearest dialysis facility is many miles from a patient's home, which can cause door-to-door treatment times to consume a significant portion of a patient's day. Treatments at facilities closer to the patient's home can also consume a significant portion of a patient's day. HHD can be performed at night or during the day when the patient is relaxing, working, or productive.

[0008] Another type of renal failure therapy is peritoneal dialysis ("PD"), in which a dialysis solution, also called dialysate or PD fluid, is infused through a catheter into a patient's peritoneal cavity. The PD fluid contacts the peritoneal membrane within the patient's peritoneal cavity. Waste, toxins, and excess water enter the PD fluid from the patient's bloodstream through the peritoneal capillaries by diffusion and osmosis (i.e., an osmotic gradient is created across the membrane). An osmotic agent in the PD fluid provides the osmotic gradient. The spent PD fluid is pumped out of the patient, removing the waste, toxins, and excess water from the patient. This cycle can be 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 flow dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis treatment. In this, a 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 in communication with a bag of fresh PD fluid and infuses fresh PD fluid into the patient through the catheter. The patient disconnects the catheter from the bag of fresh PD fluid, allowing the PD fluid to dwell in the patient's peritoneal cavity, transporting waste, toxins, and excess water. After a dwell period, the patient repeats the manual dialysis procedure, for example, four times a day. Manual peritoneal dialysis requires significant patient time and effort and leaves significant room for improvement.

[0010] APD is similar to CAPD in that dialysis treatment involves drain, fill, and dwell cycles. However, APD devices perform these cycles automatically, usually while the patient sleeps. APD devices relieve patients of having to manually perform treatment cycles and transport supplies during the day. APD devices are fluidly connected to an implanted catheter, a source or bag of fresh PD fluid, and a fluid drain. The APD device pumps fresh PD fluid from the dialysate source through the catheter and into the patient's peritoneal cavity. APD devices also allow the PD fluid to dwell within the cavity, transporting waste, toxins, and excess water. The source may contain multiple liters of dialysate, including several solution bags.

[0011] APD devices pump spent PD fluid from the patient's peritoneal cavity and drain it through a catheter. Similar to the manual process, several drain, fill, and dwell cycles occur during dialysis. A "final fill" can occur at the end of an APD treatment. The final fill fluid may remain in the patient's peritoneal cavity until the start of the next treatment, or it may be manually emptied at some point during the day.

[0012] Patients for both CAPD and APD are provided with a transfer set connected to the patient's indwelling catheter, which is located in the patient's peritoneal cavity. The transfer set connects to a patient line during treatment, allowing fresh PD fluid to be delivered to the patient and spent PD fluid to be removed from the patient. One known transfer set 110 is illustrated in Prior Art FIG. 1. The known transfer set 110 includes a body 112 that threads onto a port adapter 114 at one end and onto a sleeve 116 at the opposite end. The port adapter 114 is fitted with a cap 118. The cap 118 is removed from the port adapter 114 to allow a patient line connector (not shown) of a patient line to be connected to the connecting end 114c of the port adapter 114 on the patient's transfer set. A transfer set line 120 extends from the hose-barbed end of the port adapter 114 to the patient's indwelling catheter (not shown).

[0013] While the patient line connector is a male luer connector, the connection end 114c of the port adapter 114 as shown is a female luer connector. Connection of the male luer patient line connector to the female luer connection end 114c is a major source of contact contamination. Contact contamination is one of the leading causes of peritonitis, which is the most common infection and reason for procedural failure for PD. Peritonitis is the leading cause of PD patient dropout in the first 90 to 120 days of therapy. Therefore, a need exists for an improved PD transfer set that reduces the likelihood of contact 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 [Means for solving the problem]

[0014] The present disclosure describes an improved peritoneal dialysis ("PD") transfer set. In one embodiment, the PD transfer set includes four components: a base, a slider, a shroud barrel, and a mini-cap. Any one or more or all of the transfer set components may be formed, e.g., molded, from a thermoplastic material 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 faces the patient during use. In one embodiment, the larger-diameter cylindrical portion is provided with serrations for a user, such as a patient, to grasp the cylindrical portion and manipulate the transfer set. The larger-diameter cylindrical portion is open at its outer end facing the patient, allowing a flexible tube, such as a silicone tube, to extend from the patient's indwelling catheter into the transfer set. At its other end, the larger-diameter cylindrical portion includes a circular, washer-shaped flange wall that extends inward from the larger-diameter portion to a central hole or opening. A port, having an inner diameter the same as, or perhaps slightly larger than, the diameter of the hole, extends at least partway through the larger-diameter portion. The port illustrated herein, in one embodiment, is sized to receive the elongated tube of the slider. The outer diameter of the elongated tube of the slider can be sized so that a tube, such as a silicone tube, extending from the patient's indwelling catheter covers and seals against the outside of the elongated tube of the slider.

[0016] The base also includes a tubular portion extending from, e.g., formed therewith, the larger-diameter cylindrical portion. The tubular portion extends from the circular washer-shaped flange wall in a direction opposite the port. In one embodiment, the tubular portion of the base is formed with a diameter smaller than the larger-diameter cylindrical portion and larger than the port. In one embodiment, the length of the tubular portion of the base is large enough to accommodate sliding movement of the slider head. To that end, the tubular portion of the base is provided with at least one, and in one embodiment, two, linear through-slots extending completely through the wall of the tubular portion. The linear through-slots are sized to receive protrusions, e.g., protrusions in each slot, extending outward from the slider head. In one embodiment, the tubular portion and the base including the slider do not rotate during operation. Instead, the slider including the protrusions slides along the base, and the through-slots provide translational guidance for the slider.

[0017] In addition to the through slot in the tubular portion, the port in the base also functions as a guide for the movement of the slider. The port receives the elongated tube of the slider and, during operation, radially constrains the elongated tube as it slides within the port.

[0018] The cycler end of the tubular portion of the transfer set base, in one embodiment, is provided with internal threads that threadingly engage the external threads of the mini-cap. The mini-cap seals the interior of the transfer set during sterilization, shipping, and storage prior to use. The mini-cap, in one embodiment, is removed and discarded to connect the transfer set for treatment.

[0019] The transfer set slider referred to herein, in one embodiment, includes an elongated tube extending to the head of the slider. The diameter of the elongated tube is sized to fit relatively snugly within the port in the transfer set base and to fit sealingly within the flexible tubing extending from the patient's indwelling catheter. Although not shown, the end of the elongated tube may be formed with a connector, e.g., a Luer-type connector, that mates with a connector, e.g., a Luer-type connector, provided on the end of the flexible tubing extending from the patient's indwelling catheter. The larger diameter cylindrical portion of the base is large enough to receive the elongated tube (and the mating connector of the indwelling catheter tubing, if provided).

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

[0021] The slider head includes a transverse wall extending outward from an inner portion of the head. The transverse wall extends to an outer cylindrical wall of the slider head. The transverse wall, cylindrical wall, and inner portion of the slider head are, in one embodiment, integrally formed, e.g., molded, 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 snugly within the inner surface of the tubular portion of the base.

[0022] One or more protrusions, for example, two protrusions at 180° to each other, extend from the outer surface of the cylindrical wall of the slider head. The diameter of the at least one protrusion is sized to fit snugly within the linear through-slot of the tubular portion of the base. The height of the at least one protrusion is sized to extend completely through the at least one linear through-slot of the tubular portion of the base sufficiently to extend into the at least one helical groove of the shroud barrel. As shown, the position of the transverse wall extending to the middle portion of the cylindrical wall of the slider head allows the cylindrical wall to bend. The bending of the cylindrical wall allows the at least one protrusion to be snap-fit into the at least one mating through-slot of the tubular portion of the base during manufacturing. After snapping the at least one protrusion into the at least one mating through-slot, the slider is slidably constrained within the base of the transferset.

[0023] The shroud barrel as illustrated is generally located around the outside of the tubular portion of the base. The shroud barrel, in an embodiment, is formed to define at least one blind spiral groove that extends at least 20 millimeters, e.g., 24 millimeters (approximately 1 inch), around the inner surface of the shroud barrel. The end of the at least one protrusion of the slider extends into the at least one blind spiral groove of the shroud barrel. In the illustrated embodiment, the spiral groove is blind and does not extend completely through the wall of the shroud barrel, which allows the shroud barrel to better provide a sterility barrier against contact contamination. However, it should be understood that the at least one spiral groove need not be blind, and that if the at least one spiral groove instead extends completely through the wall of the shroud barrel, movement of the slider during operation will operate as described.

[0024] In one embodiment, the at least one dead-end spiral groove is oriented such that when a user or patient rotates the shroud barrel in a clockwise direction, the slider is translationally advanced so that the female luer connector on the head of the slider extends toward a connection position with the male luer connector of the patient line connector. Similarly, when a user or patient rotates the shroud barrel in a counterclockwise direction, the slider is translationally reversed so that the female luer connector on the head of the slider is retracted from the connection position. In an alternative embodiment, the orientation is reversed so that counterclockwise rotation causes slider translation toward the connection and clockwise rotation causes slider translation away from the connection.

[0025] In embodiments, the base of the disclosed transfer set does not move during actuation (or reverse actuation). The serrations on the larger-diameter cylindrical portion of the base provide a convenient location for the user or patient to steadily grasp and hold the transfer set. The slider translates relative to the base during actuation (or reverse actuation). The shroud barrel is rotated relative to the base by the user's or patient's other hand. Without the tubular portion of the base, rotation of the shroud barrel simply rotates the at least one engaged protrusion and the remainder of the slider, without translation. However, at least one linear through-slot in the tubular portion of the base prevents the slider from rotating and instead translates the slider as the at least one engaged protrusion moves through the at least one corresponding helical groove that rotates.

[0026] In light of the disclosure set forth herein, in a first aspect of the present disclosure, which may be combined with any other aspect or portion thereof without limiting the present disclosure in any way, a peritoneal dialysis ("PD") transfer set includes: a base including at least one slot; 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 protrusion extending through the at least one slot, the head further including a connector for connecting to a mating patient line connector; and a shroud barrel including at least one helical groove, the shroud barrel extending around a portion of the base such that the at least one helical groove receives the at least one protrusion, wherein a user can rotate the shroud barrel including the at least one helical groove such that the at least one protrusion extends along the at least one helical groove, and the at least one slot constrains movement of the at least one protrusion and the slider to be translational.

[0027] In a second aspect of the present disclosure that may be combined with any other aspect or portion thereof, the base includes a larger diameter cylindrical portion configured for a user to hold while the user rotates the shroud barrel, and the base further includes a tubular portion defining at least one slot.

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

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

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

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

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

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

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

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

[0036] In an eleventh aspect of the present disclosure that may be combined with any other aspect or portion thereof, the at least one spiral groove is at least one dead-end spiral groove.

[0037] In a twelfth aspect of the present disclosure that may be combined with any other aspect or portion thereof, at least one spiral groove is formed in 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 portion thereof, the at least one spiral groove extends at least 20 millimeters along the shroud barrel.

[0039] In a fourteenth aspect of the present disclosure that may be combined with any other aspect or portion thereof, the PD transfer set is configured to be positioned and arranged so that an end of at least one spiral groove allows the slider connector to meet the patient line connector, and further rotation of the shroud barrel screws the patient line connector into the slider connector.

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

[0041] In a sixteenth aspect of the present disclosure that may be combined with any other aspect or portion thereof, the PD transfer set is configured such that rotating the shroud barrel in a first direction translates the slider connector toward the patient line connector and rotating the shroud barrel in a second direction translates the slider connector away from the patient line connector.

[0042] In a seventeenth aspect of the present disclosure that may be combined with any other aspect or portion thereof, a peritoneal dialysis ("PD") transfer set includes: a base including at least one slot; a slider extending into the base, the slider configured to carry PD fluid, the slider including at least one protrusion extending through the at least one slot and a connector for connecting to a mating patient line connector; and a shroud barrel including at least one spiral groove, the at least one spiral groove extending through the at least one protrusion. The shroud barrel extends around a portion of the base to receive the slider, and a user can rotate the shroud barrel, which includes at least one spiral groove, so that the at least one protrusion extends along the at least one spiral groove, and the at least one slot constrains movement of the at least one protrusion and the slider to be translational, such that rotating the shroud barrel in a first direction translates the connector of the slider toward the patient line connector, and rotating the shroud 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 portion thereof, the at least one spiral groove includes at least one rounded protrusion positioned and arranged to provide a pause that releasably maintains the at least one projection and 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 portion thereof, a peritoneal dialysis ("PD") connection method includes providing a shroud barrel including at least one spiral groove; providing a tubular portion including at least one slot; providing a connector through which PD fluid flows, the connector including at least one protrusion extending through the at least one slot and into the at least one spiral groove; and allowing the shroud barrel to be rotated to rotate the at least one spiral groove and cause movement of the at least one protrusion and connector, the at least one slot constraining movement of the at least one protrusion and connector to be a translational movement of the connector toward a mating connector for connection or away from the mating connector after disconnection.

[0045] In a twentieth aspect of the present disclosure that may be combined with any other aspect or portion thereof, a PD connection method includes allowing a shroud barrel to be rotated in a first direction to translate the connector toward a mating connector for connection and 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 portion thereof, any of the features, functions, and alternatives described in connection with any one or more of Figures 2 to 11 may be combined with any of the features, functions, and alternatives described in connection with any other of Figures 2 to 11.

[0047] In light of the above aspects and the disclosure described herein, it is an advantage of the present disclosure to provide an improved peritoneal dialysis ("PD") transfer set.

[0048] Another advantage of the present disclosure is that it provides an improved PD transfer set that reduces touch contamination.

[0049] A further advantage of the present disclosure is that it provides an improved PD transfer set that reduces the risk of peritonitis.

[0050] Yet another advantage of the present disclosure is that it provides an improved PD transfer set that helps fluid transfer occur in a more sterile environment at the patient connection end of the transfer set, isolated from outside contamination.

[0051] Additional features and advantages are described in and apparent from the following detailed description and drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to those skilled in the art upon consideration of the drawings and description. No particular embodiment is required to have all of the advantages enumerated herein, and it is expressly contemplated that each advantageous embodiment may be separately claimed. Furthermore, it should be noted that the language used herein has been chosen primarily for purposes of readability and explanation, and not to limit the scope of the inventive subject matter. [Brief explanation of the drawings]

[0052] [Figure 1] FIG. 1 is a cross-sectional perspective view of a prior art peritoneal dialysis ("PD") transfer set.

[0053] [Figure 2] FIG. 2 is a cross-sectional elevation view of one embodiment of a PD transferset of the present disclosure with the slider retracted into the base and shroud barrel of the transferset.

[0054] [Figure 3] FIG. 3 is a cross-sectional perspective view of one embodiment of a PD transferset of the present disclosure with a slider extending into the base and shroud barrel of the transferset for connection to a patient line connector.

[0055] [Figure 4]FIG. 4 is a cross-sectional perspective view of one embodiment of a PD transferset of the present disclosure showing the protrusion of the slider extending through the slot in the base and into the groove in the shroud barrel.

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

[0057] [Figure 6] FIG. 6 is a perspective view of one embodiment of a portion of a slider of a PD transferset of the present disclosure.

[0058] [Figure 7] 7 and 8 are perspective and cross-sectional perspective views, respectively, of one embodiment of a shroud barrel of a PD transferset of the present disclosure. [Figure 8] 7 and 8 are perspective and cross-sectional perspective views, respectively, of one embodiment of a shroud barrel of a PD transferset of the present disclosure.

[0059] [Figure 9] FIG. 9 is a cross-sectional elevation view of one embodiment of a PD transfer set of the present disclosure with a patient line connector connected to the transfer set.

[0060] [Figure 10] FIG. 10 is a cross-sectional elevation view of one embodiment of a PD transfer set of the present disclosure with PD fluid flowing through the transfer set between a PD device or cycler and a patient.

[0061] [Figure 11] FIG. 11 is a cross-sectional elevation view of one embodiment of a PD transferset of the present disclosure with the patient line connector removed from the transferset. DETAILED DESCRIPTION OF THE INVENTION

[0062] Referring again to the drawings, and particularly to Figures 2 through 11, an improved peritoneal dialysis ("PD") transfer set 10 is provided. In one embodiment, the PD transfer set 10 includes four components: a base 20, a slider 50, a shroud barrel 80, and a mini-cap 90. Any one or more or all of the components of the transfer set 10 may be formed, e.g., molded, from a thermoplastic material such as polyetherimide ("PEI"), polyethersulfone ("PES"), polyamide / nylon ("PA"), acrylonitrile butadiene styrene ("ABS"), polycarbonate ("PC"), polyvinyl chloride ("PVC"), or polyetheretherketone ("PEEK").

[0063] Figures 2, 3, 4, 5, and 9-11 illustrate the base 20. The base 20 includes a larger-diameter cylindrical portion 22 that faces the patient during use. The larger-diameter cylindrical portion 22 is provided with serrations 24, in one embodiment, for a user, such as a patient, to grasp the cylindrical portion 22 and manipulate the transfer set 10. The larger-diameter cylindrical portion 22 is open at its outer end 26 facing the patient, allowing a flexible tube, such as silicone tubing 12 (see Figure 10), to extend from the patient's indwelling catheter into the transfer set 10. At its other end 28, the larger-diameter cylindrical portion 22 includes a circular, washer-shaped flange wall 30 that extends inward from the larger-diameter portion to a central hole or opening 32. A port 34, having an inner diameter the same as, or perhaps slightly larger than, the diameter of the hole, extends at least partway through the larger-diameter portion 22. The port 34 illustrated herein, in one embodiment, is sized to receive the elongated tube 52 of the slider 50. The outer diameter of the elongated 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 fits over and seals against the outside of the elongated 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 with) the larger diameter cylindrical portion 22. The tubular portion 36 extends from the circular washer-shaped flange wall 30 in a direction opposite the port 34. In one embodiment, the tubular portion 36 of the base 20 is formed with a diameter smaller than the larger diameter cylindrical portion 22 and larger than the port 34. In one embodiment, the length of the tubular portion 36 of the base 20 is sufficient to accommodate the sliding movement of the head of the slider 50. To that end, the tubular portion 36 of the base 20 is provided with at least one (two, in one embodiment) linear through-slots 38 (FIGS. 2, 5, and 9-11) that extend completely through the wall of the tubular portion. The linear through-slots 38 are sized to receive protrusions 68 (FIGS. 4, 6), such as a protrusion for each slot, that extend outward from the head 54 of the slider 50. In one embodiment, the base 20, including the tubular portion 36, and the slider 50 do not rotate during operation. Instead, the slider 50, including the protrusions 68, slides along the base 20, with the through-slots 38 providing translational guidance for the slider 50.

[0065] In addition to the slot 38 in the tubular portion 36, the port 34 in 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 restrains the elongated tube as it slides within the port during operation.

[0066] The cycler end 40 of the tubular portion 36 of the base 20 of the transfer set 10 is provided with internal threads 42 that, in one embodiment, threadingly engage with the external threads 92 of the mini-cap 90. The mini-cap 90 seals the interior of the transfer set 10 during sterilization prior to use, transportation, and storage. The mini-cap 90, in one embodiment, is removed to connect the transfer set 10 for treatment and discarded. A new mini-cap 90 can be replaced after treatment when the patient line is disconnected, and the threads 92 of the new mini-cap are coated or covered with a disinfectant.

[0067] Figures 2, 3, 4, 6, and 9-11 illustrate a slider 50. The slider 50 of the transferset 10 referred to herein, in one embodiment, includes an elongated tube 52 that extends to a head 54 of the slider 50. The diameter of the elongated tube 52 is sized to fit relatively snugly within the port 34 of the base 20 of the transferset 10 and to fit sealingly within the flexible tubing 12 (Figure 10) extending from the patient's indwelling catheter. Although not shown, the end of the elongated tube 52 may be formed with a connector (e.g., a luer connector) that mates with a connector (e.g., a luer connector) provided on the 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 connector of the elongated tube 52 (and, if provided, of the indwelling catheter tubing 12).

[0068] The head 54 of the slider 50 includes an inner portion 56 (FIGS. 2, 3, 6) having a female luer connector 60, which includes external threads 62 and a tapered female inner wall 64. The female luer connector 60 is sized, in one embodiment, to mate with a standard male luer connector 18 (FIGS. 9-11), which is a standard patient line connector located, for example, on the end of a patient line 16 extending from a PD machine or cycler 14 (FIG. 10). The male luer connector 18 includes internal threads 18f that mate with the external threads 62 of the female luer connector 60 on the head 54 of the slider 50. The male luer connector 18 also includes a tapered port 18p that sealingly engages a tapered inner female wall 64 of the female luer connector 60 on the head 54 of the slider 50 to form a fluid-tight connection between the transferset 10 and the patient line connector 18. The connection between the transferset 10 and the patient line connector 18 in alternative embodiments may be 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 outward from an inner portion 56 of the head 54. The transverse wall 58 extends to an outer cylindrical wall 66 of the head 54 of the slider 50. The transverse wall 58, the cylindrical wall 66, and the inner portion of the head 54 of the slider 50, in one embodiment, are integrally formed, e.g., molded, with the elongated tube 52 of the slider 50. The radial length of the transverse wall 58 and the outer diameter of the cylindrical wall 66, in one embodiment, are sized so that the cylindrical wall 66 fits relatively snugly within the inner surface of the tubular portion 36 of the base 20.

[0070] One or more protrusions 68 ( FIGS. 4 and 6 ), for example, two protrusions 68 positioned 180° from one another, extend from the outer surface of the cylindrical wall 66 of the head 54 of the slider 50. The protrusions 68 may be formed with the cylindrical wall 66 or may be attached (e.g., threaded) to the cylindrical wall. The diameter of at least one protrusion 68 is sized to fit snugly within the linear through-slot 38 of the tubular portion 36 of the base 20. The height of the at least one protrusion 68 is sized so that it extends all the way through the at least one linear through-slot 38 of the tubular portion 36 of the base 20 (sufficiently so that it can extend into the at least one spiral groove 82 of the shroud barrel 80). As shown, the position of the transverse wall 58 extending to the intermediate portion 66 m of the cylindrical wall 66 of the head 54 of the slider 50 allows the cylindrical wall to flex. The curvature of the cylindrical wall 66 allows the at least one protrusion 68 to be snap-fit into the mating at least one through-slot 38 in the tubular portion 36 of the base 20 during manufacturing. After the at least one protrusion 68 is snap-fit into the mating at least one through-slot 38, the slider 50 is slidingly constrained within the base 20 of the transferset 10. The at least one protrusion 68, in one embodiment, is spring-loaded so that the at least one protrusion 68 is compressed during manufacturing and then snaps through the at least one slot 38 and / or the at least one helical groove 82.

[0071] 2, 3, 4, and 7-11 illustrate a shroud barrel 80. The shroud barrel 80 as illustrated is generally positioned around the outside of the tubular portion 36 of the base 20. The shroud barrel 80, in an embodiment, is formed to define at least one blind spiral groove 82 that extends at least 20 millimeters, e.g., 24 millimeters (approximately 1 inch), around the inner surface of the shroud barrel. An end of the at least one protrusion 68 of the slider 50 extends into the at least one blind spiral groove 82 of each of the shroud barrels 80. In the illustrated embodiment, the spiral groove 82 is blind and does not extend all the way through the wall of the shroud barrel 80, which allows the shroud barrel to better provide a sterility barrier against touch contamination. However, it should be understood that the at least one spiral groove 82 need not be a dead end, and that movement of the slider 50 during operation will operate as described if the at least one spiral groove instead extends all the way through the wall of the shroud barrel 80.

[0072] The at least one dead-end spiral groove 82 is oriented, in one embodiment, such that when a user or patient rotates the shroud barrel 80 in a clockwise direction, the slider 50 is translationally advanced, thereby extending the female luer connector 60 on the head 54 of the slider 50 toward a connection position with the male luer connector 18 (which is the patient line connector). Similarly, when a user or patient rotates the shroud barrel 80 in a counterclockwise direction, the slider 50 is translated in the opposite direction, thereby retracting the female luer connector 60 on the head 54 of the slider 50 from the connection position. In an alternative embodiment, the orientation is reversed, such that a counterclockwise rotation causes slider translation toward the connection and a clockwise rotation causes slider translation away from the connection.

[0073] 8 further illustrates that each dead-end spiral groove 82 can include or define at least one bump or semicircular protrusion 82b that extends inward into the spiral groove. The at least one bump or rounded protrusion 82b helps initiate translational movement of the corresponding protrusion 68 and provides a smooth ramp / fillet for the protrusion. The at least one bump or semicircular protrusion 82b located at each end of the spiral groove 82 also functions as a pause or locking feature to releasably maintain the corresponding protrusion 68 and slider 50 in the fully extended and fully retracted positions, discussed below.

[0074] In an embodiment, the base 20 of the transferset 10 of the present disclosure does not move during actuation (or reverse actuation). The serrations 24 on the larger-diameter cylindrical portion 22 of the base 20 provide a convenient location for the user or patient to firmly grasp and hold the transferset 10. The slider 50 translates relative to the base 20 during actuation (or reverse actuation). The shroud barrel 80 is rotated relative to the base 20 by the user's or patient's other hand. Without the tubular portion 36 of the base 20, rotation of the shroud barrel 80 would simply rotate the at least one engaged protrusion 68 and the remainder of the slider 50, without translation. The at least one linear through-slot 38 in the tubular portion 36 of the base 20, however, prevents the slider 50 from rotating and instead allows the slider 50 to translate as the at least one engaged protrusion 68 moves through the at least one corresponding spiral groove 82 that rotates.

[0075] FIG. 2 illustrates a first connection step, in which a user or patient removes (e.g., unscrews) the mini-cap 90 (or other cap) from the internal threads 42 of the base 20. In FIG. 2, the slider 50 is in a fully retracted position. FIG. 9 illustrates a second connection step, in which a user or patient turns (or rotates) the shroud barrel 80 (e.g., clockwise), moving the at least one protrusion 68 and slider 50 along the at least one helical groove 82, with the linear slot 38 in the base constraining the slider 50 to sliding or translational movement. In FIG. 9, the slider has been translated to the fully extended end of the at least one helical groove 82 and can mate with the patient connector 18. Now, the user may (i) continue to rotate the shroud barrel 80 to thread the male Luer connector 18 into the female Luer connector 60 of the slider 50, (ii) rotate the male Luer connector 18 to thread the male Luer connector 18 into the female Luer connector 60 of the slider 50, or (iii) rotate both the shroud barrel 80 and the male Luer connector 18 to thread the male Luer connector 18 into the female Luer connector 60 of the slider 50. In either case, in FIG. 10 , once the male Luer connector 18 is fully sealed onto the female Luer connector 60, treatment may proceed with fresh and spent PD fluid moving back and forth through the transfer set 10 between the PD device 14 and the patient. 11, after treatment, the user or patient removes (unscrews) the male luer connector 18 from the female luer connector 60 of the slider 50 and rotates the shroud barrel 80 in the opposite direction (e.g., counterclockwise) to return the slider to the fully retracted position of FIG. 2. The user or patient can then thread a new mini-cap with antiseptic onto the threads 42 of the base 20.

[0076] It should be appreciated that during the above connecting and disconnecting steps, the mating surfaces of male luer connector 18 and female luer connector 60 are protected from contact contamination by both tubular portion 36 of base 20 and shroud barrel 80. Female luer connector 60 is maintained within tubular portion 36 of base 20 and shroud barrel 80 at all times.

[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. Accordingly, it is intended that any or all such changes and modifications may be covered by the appended claims. For example, while transfer set 10 is illustrated showing slider 50 having a female luer connector 60 and patient connector 18 being a male luer connector, alternatively, slider 50 may be provided with a male luer connector and patient connector 18 may be provided with a female luer connector, or vice versa. Also, cap 90 may be any suitable cap and need not be a mini-cap.

Claims

1. 1. A peritoneal dialysis ("PD") transfer set, the PD transfer set comprising: a base including at least one slot; 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 protrusion extending through the at least one slot, the head further including a connector for connecting to a mating patient line connector; a shroud barrel including at least one spiral groove; Equipped with A PD transfer set, wherein the shroud barrel extends around a portion of the base such that the at least one spiral groove receives the at least one protrusion, and a user rotates the shroud barrel including the at least one spiral groove, whereby the at least one protrusion extends along the at least one spiral groove, and the at least one slot constrains movement of the at least one protrusion and the slider to translational movement.

2. 2. The PD transfer set of claim 1, wherein the base includes a larger diameter cylindrical portion configured for the user to hold while the user rotates the shroud barrel, and the base further includes a tubular portion that defines the at least one slot.

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

4. 3. The PD transfer set of claim 2, wherein an end of the tubular portion is provided with threads for mating with threads of a cap configured to seal the transfer set prior to treatment.

5. 3. The PD transferset of claim 2, wherein the inner diameter of the tubular portion is sized to fit snugly around the head of the slider.

6. 3. The PD transfer set of claim 2, wherein the tubular portion of the base and the shroud barrel are positioned and arranged to inhibit contact contamination of the connection between the slider connector and the patient line connector.

7. The PD transferset of claim 1 , wherein the at least one slot is a straight slot.

8. The PD transfer set of claim 1 , wherein the connector of the slider is a luer connector.

9. 2. The PD transfer set of claim 1, wherein the slider includes an inner portion providing the connector, a transverse wall extending from the inner portion to a cylindrical wall, and the at least one protrusion extending from the cylindrical wall.

10. The PD transferset of claim 1 , wherein the shroud barrel extends around the tubular portion of the base.

11. The PD transferset of claim 1 , wherein the at least one spiral channel is at least one dead-end spiral channel.

12. The PD transferset of claim 1 , wherein the at least one spiral groove is formed in an interior surface of a shroud barrel.

13. The PD transferset of claim 1 , wherein the at least one spiral groove extends at least 20 millimeters along the shroud barrel.

14. 2. The PD transfer set of claim 1, wherein an end of the at least one spiral groove is positioned and configured to allow the connector of the slider to meet the patient line connector, and further rotation of the shroud barrel threads the patient line connector into the connector of the slider.

15. 2. The PD transfer set of claim 1, wherein an end of the at least one spiral groove is positioned and configured to allow the connector of the slider to meet the patient line connector, and wherein rotating the patient line connector threads the patient line connector into the connector of the slider.

16. 10. The PD transfer set of claim 1, wherein rotating the shroud barrel in a first direction translates the connector of the slider toward the patient line connector and rotating the shroud barrel in a second direction translates the connector of the slider away from the patient line connector.

17. 1. A peritoneal dialysis ("PD") transfer set, the PD transfer set comprising: a base including at least one slot; a slider extending within the base, the slider configured to carry PD fluid, the slider including at least one protrusion extending through the at least one slot and a connector for connecting to a mating patient line connector; a shroud barrel including at least one spiral groove; Equipped with the shroud barrel extends around a portion of the base such that the at least one helical groove receives the at least one protrusion, a user rotates the shroud barrel including the at least one helical groove, whereby the at least one protrusion extends along the at least one helical groove, the at least one slot constrains movement of the at least one protrusion and the slider to translational movement, wherein rotating the shroud barrel in a first direction translates the connector of the slider toward the patient line connector and rotating the shroud barrel in a second direction translates the connector of the slider away from the patient line connector.

18. 18. The PD transfer set of claim 17, wherein the at least one spiral groove includes at least one rounded protrusion positioned and arranged to provide a pause, the at least one rounded protrusion releasably maintaining the at least one protrusion and slider in a position toward or away from the patient line connector.

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

20. 20. The PD connection method of claim 19, including allowing the shroud barrel to be rotated in a first direction to translate the connector toward the mating connector for connection and in a second direction to translate the connector away from the mating connector after disconnection.

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