Dialysis assistance systems and methods

Abstract

The present disclosure relates to a magnet-based system for assisting peritoneal dialysis, such as continuous ambulatory peritoneal dialysis (CAPD), and methods of using the same.

Description

Technical Field

[0001] The present disclosure relates to a dialysis system, and more particularly, to a system or method for facilitating peritoneal dialysis, such as continuous ambulatory peritoneal dialysis (CAPD). Background Art

[0002] Peritoneal dialysis (PD) is a treatment for kidney failure that uses the peritoneum, the lining of the abdominal cavity, to filter a patient's blood to remove waste products and excess fluid. To perform PD, a permanent catheter is surgically implanted in the patient's abdominal cavity. In contrast to automated peritoneal dialysis, CAPD is a type of PD that is performed by hand without the use of a machine.

[0003] Due to the significantly higher costs associated with hemodialysis (HD) and the cost-effectiveness of PD, Hong Kong, China, introduced a "peritoneal dialysis first" (PD-first) policy in 1985. Under this policy, all patients requiring dialysis are treated first with PD unless medical contraindications exist. Choy et al. reported that under the PD-first policy, 72.9% of the dialysis population in Hong Kong, China, was treated with PD in 2012, the highest rate worldwide. Furthermore, Leung et al. reported a PD-to-HD ratio of 76.2% to 23.8%. Eighty-six percent of all PD patients received CAPD; the remaining 14% received automated peritoneal dialysis (Sustainability of the Peritoneal Dialysis-First Policy in Hong Kong, Choy A SM. Li P KT, Blood Purif 2015;40:320–325; A Global Overview of the Impact of Peritoneal Dialysis First or Favored Policies: An Opinion, Liu et al., Perit Dial Int. 2015 Jul-Aug; 35(4): 406–420; Renal registry in Hong Kong - the first 20 years, Leung et al., Kidney Int Suppl (2011). 2015 Jun; 5(1): 33-38). CAPD is the most common treatment modality for patients with end-stage renal failure in Hong Kong, China.

[0004] To perform PD, patients using CAPD have approximately 2 liters of dialysate dripped into the peritoneal cavity through a surgically implanted catheter. A peritoneal catheter, also known as a tube or Tenckhoff, is a flexible tube 50-60 cm long. A portion of the catheter is fixed to the outside of the body and connected to a connector that attaches to a short, interchangeable extension tube for connection to the tubing of the peritoneal dialysis fluid bag.

[0005] PD fluid, supplied in a bag typically suspended from a wheeled stand during use, is passed through a catheter into the patient's peritoneal cavity. The effluent, along with impurities from the blood and excess fluid, is typically drained after 6-8 hours. The peritoneal cavity is then refilled with a new bag of dialysate. Typically, patients will require three to five dialysate changes per day, with each dialysis treatment lasting approximately one hour.

[0006] Peritonitis is a major complication of PD and a common cause of death in PD patients (Risk Factors Associated with Peritoneal-Dialysis-Related Peritoniti, Kerschbaum et al., Int J Nephrol. 2012; 2012: 483250). Other common complications include inflammation at the exit site of the catheter and inflammation under the skin along the catheter. These infections can occur when contaminants, bacteria, and fungi come into contact with the surfaces of the PD kit, during the connection and disconnection of the PD dialysate bag and the patient's catheter, or when a new cap is connected to the patient's catheter after dialysis is completed. The risk of infection is particularly high because the PD procedure needs to be repeated within a day. Therefore, it is crucial that patients undergoing CAPD are able to maintain a sterile environment during the connection and disconnection procedures, for example, by maintaining good hand hygiene and reducing the number of times the tubing and catheter of the dialysis bag are opened.

[0007] In order to perform PD in a sterile manner that minimizes exposure to infection, patients who typically undergo CAPD at home will need to have good vision, manual function, eye-hand coordination, and cognition. However, a large proportion of patients requiring CAPD are elderly and may have impaired vision or poor hand function due to pre-existing conditions. For example, it was reported that in Hong Kong, China, 53% of all patients identified as requiring renal replacement therapy (RRT) in 2017 were also diagnosed with diabetes. Patients with diabetes often exhibit other complications, including diabetic retinopathy and diabetic peripheral neuropathy, which lead to poor vision and hand function, respectively.

[0008] Despite the benefits of home dialysis, such as patient control, self-esteem, improved survival, less exposure to hospital-acquired infections, and reduced burden on caregivers and medical staff, the ability of patients with end-stage renal disease (ESRD) to qualify for CAPD at home is significantly limited due to the increased risk of contamination. In other words, increasing the proportion of patients who are eligible for CAPD, especially among the subpopulation of patients with impaired vision and hand-eye coordination, is a clinical, social, and economic challenge.

[0009] US Pat. No. 5,611,506 by Berger et al. describes a dialysis assist device (e.g., EZ-Aide TM A device is commercially available that facilitates fluid exchange for PD patients, wherein a tray contains a keyhole-shaped aperture for tubing and a connector that supports a PD bag, enabling a patient with one-handed function to connect the patient's catheter to the tubing via the connector. However, it should be understood that such a device can be difficult to use for patients with poor vision, impaired eye-hand coordination, and hand tremors.

[0010] CN205339695U by Yu et al. proposes a device utilizing T-shaped rails mounted on a fixed plate to facilitate the connection of patient catheters and tubing to dialysis bags. The disclosed device relies on a platform secured by first and second rails and a metal bead slide system to prevent contamination and accurately position the peritoneal dialysis fluid connector and tubing. The multi-component assembly consumes space and increases contamination rates, and the metal bead slide system requires the use of lubricants, potentially leaving debris that could lead to infection.

[0011] The inventors of the present disclosure previously disclosed a three-component PD assist device, which has been put into clinical practice in Hong Kong, China. The PD assist device includes a guide rail and two spoon-shaped components, each of which is configured to engage the end of a peritoneal catheter with the end of a dialysis solution line to facilitate coupling and uncoupling of the peritoneal catheter and the dialysis solution line. However, this device can still present some difficulties for patients with impaired vision and / or hand-eye coordination.

[0012] Hong Kong Short-term Patent Application No. 19129395.0 discloses a track-based dialysis assist device that involves connecting tubing to an open system. However, the use of the device is limited by the need for a flat surface.

[0013] It is an object of the present disclosure to provide an improved apparatus and method for facilitating fluid exchange occurring during peritoneal dialysis with reduced risk of contamination, and to address or ameliorate the deficiencies of prior art devices; particularly when used by patients suffering from additional medical conditions. Summary of the Invention

[0014] The features and advantages of the present disclosure will be set forth in the following description and in part will become apparent from the description or can be learned by practicing the principles disclosed herein. The features and advantages of the present disclosure can be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims.

[0015] According to a first aspect of the present disclosure, a dialysis assist system is provided, comprising: a first shell that is releasably engageable at least partially around a peritoneal catheter; and a second shell that is releasably engageable around a tubing inserted into the second shell, the tubing being in communication with a peritoneal dialysis solution reservoir; wherein the first shell comprises at least one first magnetic portion disposed in or on the first shell, and the second shell comprises at least one second magnetic portion disposed in or on the second shell, such that when the first shell and the second shell become close to each other, magnetic attraction between the first magnetic portion and the second magnetic portion causes the peritoneal catheter to align with the tubing to engage with the tubing so as to define a fluid pathway between the peritoneal catheter and the tubing.

[0016] According to a preferred embodiment of the present disclosure, the first magnetic portion includes a plurality of first magnetic members, and the second magnetic portion includes a plurality of second magnetic members. Preferably, one of the magnetic members is a permanent magnet, and another of the magnetic members is made of a ferromagnetic material that can be attracted to the other magnetic member when the ferromagnetic material is close to the other magnetic member.

[0017] According to a preferred embodiment of the present disclosure, the second housing is releasably engageable about a removable tube retainer to position the conduit in the second housing.

[0018] Advantageously, the tube holder is movable along a channel defined in the second housing and rotatable within the second housing such that the tubing and the peritoneal catheter threadably engage at their respective ends to define said fluid pathway.

[0019] According to another preferred embodiment of the present disclosure, the first housing includes complementary clamping portions that are hingedly attached to each other to receive the peritoneal catheter therebetween, and the second housing includes complementary clamping portions that are hingedly attached to each other, wherein a channel is defined in the complementary clamping portions to receive the tube holder.

[0020] Each of the complementary clamping parts of the first shell and the second shell may include at least one third magnetic part and a fourth magnetic part, and the at least one third magnetic part and the fourth magnetic part are arranged in or on the complementary clamping part, so that when the clamping parts become close to each other, the magnetic attraction between the third magnetic part and the fourth magnetic part pushes the clamping part into engagement around the conduit or the tube holder respectively received in the clamping part.

[0021] According to a preferred embodiment of the present disclosure, the third magnetic part includes a plurality of third magnetic components, and the fourth magnetic part includes a plurality of fourth magnetic components; and preferably, one of the magnetic components is a permanent magnet, and the other magnetic component of the magnetic components is made of ferromagnetic material, which can be attracted by the other magnetic component when approaching the other magnetic component.

[0022] In a preferred embodiment, the cross sections of the complementary clamping parts together define a ring when the cross sections of the complementary clamping parts are moved towards each other.

[0023] The dialysis auxiliary system of the present disclosure may further include a sealing device for reversibly sealing and unsealing the end of the peritoneal catheter, wherein the sealing device includes: a handle that can be engaged around the cover; a third shell that can be engaged around the handle; wherein the third shell includes at least one fifth magnetic part, and the at least one fifth magnetic part is arranged in or on the third shell, so that when the first shell and the third shell become close to each other, the magnetic attraction between the first magnetic part and the fifth magnetic part causes the peritoneal catheter to engage with the handle of the sealing device.

[0024] According to a preferred embodiment of the present disclosure, the first magnetic portion of the first housing includes a plurality of first magnetic members, and the fifth magnetic portion of the capping device includes a plurality of fifth magnetic members. Preferably, one of the magnetic members is a permanent magnet, and another of the magnetic members is made of a ferromagnetic material that is attracted to the other magnetic member when in proximity to the other magnetic member.

[0025] According to another preferred embodiment of the present disclosure, the third housing includes complementary clamping portions hingedly attached to each other, wherein a channel is defined in the complementary clamping portions to receive the handle of the capping device.

[0026] Each of the complementary clamping parts of the third shell can include at least one fourth magnetic part and a fifth magnetic part, and the at least one fourth magnetic part and the fifth magnetic part are arranged in or on the complementary clamping part, so that when the clamping parts become close to each other, the magnetic attraction between the fourth magnetic part and the fifth magnetic part pushes the clamping part into engagement around the handle received in the clamping part.

[0027] According to a preferred embodiment of the present disclosure, the fourth magnetic part includes a plurality of fourth magnetic components, and the fifth magnetic part includes a plurality of fifth magnetic components; and preferably, one of the magnetic components is a permanent magnet, and the other magnetic component of the magnetic components is made of ferromagnetic material, which can be attracted by the other magnetic component when approaching the other magnetic component.

[0028] In a preferred embodiment, the cross sections of the complementary clamping portions of the third housing together define a ring when the cross sections of the complementary clamping portions are moved towards each other.

[0029] Advantageously, the handle of the capping device is movable along a channel defined in the third housing and is rotatable within the third housing to cap or uncap the peritoneal catheter.

[0030] In a preferred embodiment, the handle comprises a cap engaging end and an end having a configuration for user engagement therewith.In yet another preferred embodiment, the first housing, the second housing and the third housing are provided in different colours.

[0031] According to a second aspect of the present disclosure, there is provided a method for providing assisted peritoneal dialysis using the dialysis assist system described above, the method comprising:

[0032] (a) engaging one end of a peritoneal catheter with the first housing;

[0033] (b) coupling the end of the tubing in communication with the peritoneal dialysis solution to the second housing;

[0034] (c) moving the first housing and the second housing toward and toward each other to couple the end of the peritoneal catheter with the end of the tubing for the peritoneal dialysis solution, thereby defining a fluid pathway between the peritoneal catheter and the tubing.

[0035] Advantageously, the method of the present disclosure further comprises, prior to step (a), removing the cap from the end of the peritoneal catheter by:

[0036] - coupling the first housing to the third housing of the capping device as described above; and

[0037] - rotating the handle of the capping device within the third housing to remove the cap.

[0038] The method of the present disclosure may further comprise the following steps:

[0039] - placing the new cap in the handle of the capping device, which is housed in the third housing described above;

[0040] - bringing the first housing and the third housing closer to each other;

[0041] - Rotating the handle of the capping device to attach the new cap to the end of the peritoneal catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] The preferred embodiments of the present disclosure will be further explained in detail below by way of examples and with reference to the accompanying drawings, in which:

[0043] Figure 1 An embodiment of a first housing is depicted connected to an embodiment of a second housing.

[0044] Figure 2A Depicts from Figure 1 00100 is a perspective view of an exemplary first housing in a closed state of the embodiment depicted in FIG.

[0045] Figure 2B Depicts Figure 2A A perspective view of an exemplary first housing in an open state.

[0046] Figure 2C Depicts catheter positioning to Figure 1 On the embodiment of the dialysis assist system depicted in .

[0047] Figure 3A An embodiment of the second housing is depicted in a closed state.

[0048] Figure 3B Depicts Figure 3A An embodiment of the second shell in an open state.

[0049] Figure 3C An embodiment of the tube holder is depicted in a closed state.

[0050] Figure 3D Depicts Figure 3C Embodiment of a tube holder in an open state.

[0051] Figure 3E Depicts Figure 3C An exemplary tube holder with Figure 3A Positioning of the exemplary second housing depicted in .

[0052] Figure 4 An embodiment of a first housing is depicted coupled to an embodiment of a capping assembly wherein a handle of the capping assembly is positioned within a channel of a third housing.

[0053] Figure 5A A perspective view of an embodiment of a third housing of a capping assembly is depicted in a closed state.

[0054] Figure 5B Describes how Figure 5A An exemplary third housing of the cover seal device depicted in FIG. 1 is in an open state.

[0055] Figure 5C An embodiment of a handle for a capping device is depicted.

[0056] Figure 5D Depicts an exemplary handle with Figure 5A Positioning of the exemplary third housing depicted in . DETAILED DESCRIPTION

[0057] In order to describe the manner in which the above and other advantages and features of the present disclosure can be obtained, a more particular description of the principles briefly described above will be presented by reference to specific embodiments thereof illustrated in the accompanying drawings. It should be understood that these drawings depict only exemplary embodiments of the present disclosure and are therefore not to be considered limiting of its scope. The principles herein are described and explained in more detail and detail through the use of the accompanying drawings.

[0058] definition

[0059] "Peritoneal dialysis," as described herein, refers to a dialysis treatment in which a dialysate is introduced into a patient's peritoneal cavity, and subsequently drained, to remove impurities and excess fluid from the blood.

[0060] As described herein, "CAPD" refers to peritoneal dialysis performed without a machine, typically at home by the patient or their caregiver. "CAPD-associated peritonitis" refers to an infection of the abdominal cavity that is a common, major complication in patients undergoing CAPD.

[0061] As used herein, a "peritoneal catheter" refers to an elongated tube, typically made of flexible plastic (e.g., silicon, Tenckhoff catheter), that is surgically inserted into the patient's abdominal cavity. As used herein, a peritoneal catheter also refers to any extension tubing, including any extension sleeve or extension line (e.g., transfer sleeve).

[0062] The "cap" described herein refers to the cap of the peritoneal catheter (or extension of the catheter), which is sometimes called the MiniCap, M cap, and is usually provided with povidone-iodine solution. Each CAPD treatment requires a new sterile cap, which is provided in a sealed sterile bag.

[0063] With reference to the accompanying drawings, Figure 1 An exemplary embodiment of a dialysis assist system according to the present disclosure is shown. The system includes a first housing (12) that can be releasably engaged at least partially around a peritoneal catheter (14), which can be a catheter or the end of an extension tubing connected to the catheter; and a second housing (16) that can be releasably engaged around tubing (18) inserted into the second housing. The tubing disposed in the second housing can be connected to a dialysis bag containing a peritoneal dialysis solution (not shown) for performing peritoneal dialysis.

[0064] As shown in Figures 2-3, the first shell (12) of the system may include at least one first magnetic part (20), which is disposed in or on the first shell, and the second shell (16) may include at least one second magnetic part (22), which is disposed in or on the second shell.

[0065] When the first shell and the second shell are placed in close proximity to each other, the two shells are connected due to the magnetic attraction between at least one first magnetic portion (20) of the first shell and at least one second magnetic portion (22) of the second shell, which in turn aligns the peritoneal catheter engaged in the first shell with the tubing engaged in the second shell.

[0066] When the catheter and tubing are properly aligned, the user can then easily and accurately connect the catheter and tubing by, for example, moving the tubing toward the catheter while rotating the tubing until a secure connection is established between the catheter and the tubing. The connected elements can be placed in the bag and elevated above the patient's body (e.g., above the user's neck) so that a fluid pathway is then created between the catheter and tubing by gravity, thereby allowing dialysate to move from the dialysis bag into and out of the patient's peritoneal cavity.

[0067] like Figures 2A-2B As shown in , the first magnetic portion (20) may include a plurality of first magnetic members (20a, 20b, 20c); and as Figures 3A-3B As shown in FIG, the second magnetic portion (22) may include a plurality of second magnetic members (22a, 22b, 22c). For example, 1-12 magnetic members, preferably 2-8 magnetic members, and more preferably 4-6 magnetic members may be provided on each housing; and optionally, as depicted, each of the magnetic members may be equally spaced from each other. The number and arrangement of the magnetic members are optimized to ensure a secure connection is formed and that the user can disconnect without excessive effort.

[0068] To provide an appropriate magnetic attraction force between the first shell and the second shell, one of the magnetic members is a permanent magnet, and the other of the magnetic members may include a ferromagnetic material that can be attracted by the other magnetic member when the two magnetic members approach each other.

[0069] In a preferred embodiment of the present disclosure, the system further comprises a removable tube holder (24) for positioning the tube within the second housing (16). The tube holder (24) is configured to secure the tube and fits within a channel within the second housing, such as Figure 3E Preferably, the tube holders can be respectively as shown in FIG. Figures 3C-3D The illustrated closed and open states provide a tube holder that may be provided with a male and a female connection element for securely locking a pipe within the tube holder in its closed state.

[0070] During use, tubing connected to a fresh dialysis bag is fitted by the user to the tubing holder (24) in its open state and is securely retained in the tubing holder when the tubing holder is closed. Alternatively, the tubing may be fitted covertly to the tubing holder, for example by forming an opening extending along the length of the holder.

[0071] When the second housing is opened (eg Figure 3B ), the user can then place the tube holder equipped with the pipeline in the second housing. When the second housing is closed, the user can move the tube holder along the channel defined in the second housing and can also manually rotate the tube holder at the same time.

[0072] Before connecting the catheter to the tubing of the dialysis bag, the pull-ring cap at the end of the tubing, which maintains sterility, can be manually removed while the tubing is retained by the tubing holder. This means that the unsealed sterile end of the tubing remains within the second housing, thereby avoiding any potential contamination by the user's hands or otherwise.

[0073] Upon connecting the first housing (containing the uncapped end of the peritoneal catheter) with the second housing (containing the uncapped end of the tubing of the dialysis bag retained in the tube holder), the user can then move the tube holder toward the end of the peritoneal catheter.

[0074] By rotating the tube holder, the end of the peritoneal catheter and the end of the tubing can be threadedly coupled to establish a fixed fluid pathway. It should be understood that the coupling occurs in a confined tunnel (cavity) that is protected from contaminants (due to contact contamination or otherwise) in preparation for dialysis.

[0075] like Figures 2A-2BAs depicted in FIG, the first housing (12) may be formed by two complementary clamping portions (28, 30) hingedly attached to each other. As depicted, the clamping portions may be opened to receive a peritoneal catheter (see FIG. Figure 2C ) and can be closed to secure the peritoneal catheter within the first housing. Figures 3A-3B As shown in , the second housing (16) can be formed by two complementary clamping parts hingedly attached to each other; the clamping parts can be opened to receive the pipe or tube holder and can be closed to secure the pipe or tube holder in the housing. Figures 3C-3D As further shown in , the tube holder (24) can also be formed by two complementary clamping parts hingedly attached to each other; the clamping parts can be opened to receive the tube and can be closed to secure the tube in the tube holder.

[0076] When the clamping portions of the first and second housings are closed toward each other, the portions retain the peritoneal catheter or tubing within the respective housings and assist in alignment and subsequent connection of the catheter to the tubing.

[0077] Preferably, each of the complementary clamping portions of the first shell and the second shell comprises at least one third magnetic portion (32) and a fourth magnetic portion (34), the at least one third magnetic portion and the fourth magnetic portion being arranged in or on the complementary clamping portion (see, for example, Figure 3B When the clamping parts are close to each other, the clamping parts (28, 30) are coupled by the magnetic attraction between the third magnetic part and the fourth magnetic part, thereby fixing the catheter or tube holder received in the housing.

[0078] Advantageously, the third magnetic portion (32) may include a plurality of third magnetic members (32a, 32b, 32c); and the fourth magnetic portion (34) may include a plurality of fourth magnetic members (34a, 34b, 34b). For example, 1-6 magnetic members, preferably 2-4 magnetic members, and more preferably 3 magnetic members may be provided on each clamping portion; and optionally, each of the magnetic members may be equally spaced from one another as depicted, but those skilled in the art will appreciate that the positions are not limited to the arrangement shown. The number and arrangement of the magnetic members may be optimized to ensure a secure connection is formed and that the user can disconnect without undue effort.

[0079] In order to provide appropriate magnetic attraction between the complementary clamping parts, one of the magnetic members located on the first clamping part is a permanent magnet, and the other magnetic member located on the second clamping part can be made of ferromagnetic material, which can be attracted by the other magnetic member when the two magnetic members approach each other.

[0080] Alternatively, the clamping portion may have a mechanical buckle or similar arrangement that is easily operable by a coordination-impaired user to secure a peritoneal catheter or tube.

[0081] Preferably, the cross-sections of the complementary clamping parts together define a ring (ie an O-shape) when the complementary clamping parts are moved towards each other.

[0082] In one embodiment of the present disclosure, the dialysis assist system of the present disclosure may further include a capping device (70) for hygienically and reversibly capping and uncapping the end of the peritoneal catheter (or a transfer set or any other extension connected to the end of the catheter located outside the patient's body) before and / or after dialysis.

[0083] The capping device may include a handle (72) for engaging a cap to be removed from the end of the catheter before dialysis or a new cap to be placed on the catheter after dialysis; and a third shell (54) for engaging around the handle, for example, within a channel defined by the third shell in its closed state.

[0084] In one embodiment, the third housing includes at least one fifth magnetic portion (56) disposed in or on the third housing. When the first housing (12) and the third housing (54) are brought into proximity with each other, the two housings are coupled together by magnetic attraction between the first magnetic portion of the first housing and the fifth magnetic portion of the third housing, thereby allowing the handle of the capping device to engage with a peritoneal catheter engaged with the first housing.

[0085] Advantageously, the first magnetic portion of the first housing comprises a plurality of first magnetic members as described above, and the fifth magnetic portion (56) comprises a plurality of fifth magnetic members (56a, 56b, 56c), such as Figures 5A-5B As shown. For example, 1-12 magnetic members, preferably 2-8 magnetic members, and more preferably 4-6 magnetic members may be provided on the third housing; and optionally, each of the magnetic members may be equally spaced from one another as depicted, but those skilled in the art will appreciate that the positions are not limited to the arrangement shown. The number and arrangement of the magnetic members are optimized to ensure a secure connection while allowing the user to disconnect without undue effort.

[0086] In order to provide appropriate magnetic attraction between the first shell and the third shell, one of the magnetic members is a permanent magnet, and the other of the magnetic members is made of ferromagnetic material, which can be attracted by the other magnetic member when the two magnetic members approach each other.

[0087] like Figures 5A-5B As depicted in , the third housing (54) of the capping device may be formed by complementary clamping portions (58, 60) hingedly attached to each other. The clamping portions may be opened to receive a handle (see Figure 5B ), and can be closed to secure the handle in a channel formed in the third shell.

[0088] Preferably, each of the complementary clamping parts (58, 60) of the third housing includes at least one sixth magnetic part (62) and a seventh magnetic part (64), and the at least one sixth magnetic part and the seventh magnetic part are arranged in or on the complementary clamping part. When the clamping parts are close to each other, the clamping parts (58, 60) are coupled by the magnetic attraction between the sixth magnetic part and the seventh magnetic part, thereby fixing the handle received in the third housing.

[0089] Advantageously, the sixth magnetic portion (62) may include a plurality of sixth magnetic members (62a, 62b, 62c); and the seventh magnetic portion (64) may include a plurality of seventh magnetic members (64a, 64b, 64c). For example, 1-6 magnetic members, preferably 2-4 magnetic members, and more preferably 3 magnetic members may be provided on each clamping portion; and optionally, each of the magnetic members may be equally spaced from one another as depicted, but those skilled in the art will appreciate that the positions are not limited to the arrangement shown. The number and arrangement of the magnetic members are optimized to ensure a secure connection is formed and that the user can disconnect without undue effort.

[0090] In order to provide appropriate magnetic attraction between the complementary clamping parts, one of the magnetic members located on the first clamping part is a permanent magnet, and the other magnetic member located on the second clamping part is made of ferromagnetic material, which can be attracted by the other magnetic member when the two magnetic members approach each other.

[0091] Alternatively, the clamping portion may have a mechanical clasp or similar arrangement that is easily operable by a coordination-impaired user to secure the handle of the capping device.

[0092] Preferably, when the complementary clamping portions of the third housing are moved toward each other, the cross-sections of the complementary clamping portions together define a ring (i.e., an O-shape). Preferably, the handle (72) of the capping device (70) further includes a cap engaging end (74) and an end having a user-gripped configuration (76).

[0093] In preparation for dialysis, the user places the handle (72) of the cover device into the third housing when the third housing is arranged in its open state. Figure 5D When the third housing is closed, the user can move the handle (72) along the channel (53) defined in the third housing, and at the same time, can also manually rotate the handle (72) clockwise or counterclockwise.

[0094] During use, the first housing, which is equipped with the peritoneal catheter, and the third housing, which is engaged with the handle, are brought into proximity with each other and connected by magnetic force. By grasping the end of the handle having the engaged configuration, the user can move the handle of the capping device toward the peritoneal catheter until the cover is received in the cover engaging end (74) of the handle at the end of the peritoneal catheter. The user can then turn the handle, for example, by rotating the handle counterclockwise, to unscrew the used cover from the end of the peritoneal catheter. After this procedure, the uncapped sterile end of the catheter remains within the first housing, thereby preventing this uncapped sterile end from being accidentally touched by the user's hand or otherwise contaminated.

[0095] With the uncapped sterile end of the tubing secured within the first housing, the user has both hands free to attend to subsequent steps, such as attaching the tubing of the dialysis bag to the tubing holder / second housing, removing the pull-tab cap from the tubing of the dialysis bag, and connecting the second housing to the first housing. As described above, throughout the preparation steps, the sterile connection end remains in the sterile environment within the first and second housings.

[0096] Dialysis is then performed by connecting the first and second housings and subsequently coupling the peritoneal catheter to tubing connected to a dialysis bag.

[0097] After dialysis, a new cap is assembled to the cap engaging end (74) of the handle (72) and then placed in the third housing (50) of the capping device (70) so that the new cap remains in a sterile environment while the peritoneal catheter is separated from the tubing and the first and second housings are uncoupled.

[0098] The first housing, fitted with a peritoneal catheter with an uncapped end, and the third housing, with the handle engaged with the new cap, are brought close together and then magnetically connected. By grasping the contoured end of the handle, the user can move the handle of the capping device toward the peritoneal catheter until the cap engages the end of the peritoneal catheter and, by turning the handle clockwise, secure the new cap to the peritoneal catheter with minimal risk of contamination.

[0099] To allow users to easily identify and assemble the various components of the system, the first, second, and third housings can be provided in different colors. Advantageously, the first housing is provided in a first color, and the second housing and tube holder are provided in a second color different from the first color. Furthermore, the capping device, including the handle and third housing, can be provided in a third color different from the first and second colors.

[0100] Providing components in different colors in the manner described above is particularly helpful in assisting the user to more easily and quickly identify components required for initial assembly procedures, such as placing the tubing on the tube holder and subsequently in the second housing, and positioning the handle of the capping device in the third housing.

[0101] Furthermore, to further assist visually impaired individuals in using the dialysis assist system, various components of the system may be configured with surface features to indicate direction, prevent slipping, or facilitate gripping. The surface features of the components may include projections or depressions, for example, in the form of graphic symbols to indicate the orientation of the connection.

[0102] For example, tactile points or markers can be strategically placed on the device to provide tactile feedback and guide the user's hand movements. By feeling these points, the user can identify the correct connection and accurately perform the necessary steps of the CAPD procedure.

[0103] Each of the components of the dialysis assist system can be printed using 3-D printing technology, preferably using a durable resin. The selected material was found to meet specific requirements in terms of durability, sterility, and ease of cleaning.

[0104] The magnets to be employed in the systems disclosed herein can be selected from neodymium, samarium, alnico, and ceramic or ferrite magnets. Preferably, the magnets are neodymium iron boron (NdFeB) or samarium cobalt (SmCo) magnets. The first and second housings, the tube holder, and the capping device are sized to conform to standard catheters and dialysis tubing used in CAPD dialysis. In an exemplary embodiment, the longitudinal length of the first housing is 30-60 cm, and more preferably 40-50 cm; and the cross-sectional outer length is 40-65 cm, and more preferably 50-60 cm. The longitudinal length of the second and third housings can be 40-80 cm, and more preferably 50-70 cm; and the cross-sectional outer length can be 30-60 cm, and more preferably 40-50 cm. The longitudinal length of the tube holder can be preferably 90-125 cm, and more preferably 100-115 cm; and the cross-sectional outer length is 25-40 cm, and more preferably 30-35 cm. The longitudinal length of the handle of the capping device may be 90-125 cm, and more preferably 100-110 cm; and the cross-sectional outer length may be 25-40 cm, and more preferably 20-25 cm. The dimensions of the various components of the disclosed system may be modified and optimized as needed by one skilled in the art based on the target dialysis treatment.

[0105] The present disclosure further discloses a method for providing assisted peritoneal dialysis using the dialysis assist system described herein. The method includes the following steps: (a) engaging one end of a peritoneal catheter or the end of an extension connected to the peritoneal catheter with a first shell (12), the first shell comprising the first magnetic material described above; (b) engaging the end of the tubing connected to the peritoneal dialysis bag with a second shell (16), the second shell comprising the second magnetic material described above; and (c) moving the first shell (12) and the second shell (16) toward and toward each other so that the two shells are connected by the magnetic attraction between the first magnetic material and the second magnetic material. When the first shell and the second shell are connected, the end of the peritoneal catheter and the end of the tubing for the peritoneal dialysis solution can be easily and accurately connected in a guided manner, thereby providing a fluid pathway between the peritoneal catheter and the peritoneal dialysis bag.

[0106] Advantageously, the method of the present disclosure further includes removing the cap from the end of the peritoneal catheter prior to step (a). The cap removal step involves first coupling the first housing (12) to the third housing (54) of the capping device (50) described above. Due to the presence of magnetic material on both the first housing and the third housing, the two housings are connected by magnetic attraction when the first housing and the third housing are moved toward and toward each other. When the first housing and the third housing are connected, the handle (52) of the capping device is rotated within the third housing to remove the cap from the peritoneal catheter.

[0107] The method of the present disclosure further includes attaching a new cap to the peritoneal catheter upon completion of dialysis. Attaching the new cap includes placing the new cap in a handle of the capping device and then positioning the handle in the third housing. The first housing and the third housing are then brought toward and into contact with each other, such that the two housings are connected by magnetic attraction between the magnetic materials of the first and third housings. While the first and third housings are connected, the handle of the capping device is rotated within the third housing to attach the new cap to the peritoneal catheter.

[0108] As will be appreciated in light of this disclosure, the dialysis assist system offers numerous advantages in facilitating tubing connections through the use of magnet technology, allowing patients and caregivers to make accurate connections stress-free and hygienically.

[0109] It will be appreciated that patients suffering from renal failure often experience a loss of strength and dexterity. The task of removing the cap from the catheter, connecting the tubing, and attaching a new cap without contaminating the various components can be quite problematic.

[0110] Currently, users use their hands to directly connect the catheter and the dialysis bag, a process that requires the user to have certain hand-eye coordination skills to accurately match the two ends of the catheter with the connecting tubing of the dialysis bag. These ends are small in size (approximately 1.5-2.5 cm in diameter) and therefore pose a significant challenge to patients who lack hand-eye coordination skills or who have partially or completely impaired vision. If the user fails to connect the ends on the first try, their hands may come into contact with the end of the catheter or the end of the tubing of the dialysis bag, resulting in contact contamination, which is one of the main causes of CAPD-related peritonitis.

[0111] The system's magnetic features not only allow users with visual impairments and / or motor deficiencies (e.g., hand tremors) to accurately and quickly align and connect the catheter and dialysis bag, but the connected first and second housings also form a confined cavity similar to a closed tunnel. Thus, once connected, the system operates within a closed tunnel system, and this design effectively prevents contamination from the environment, such as dust and pet hair, further reducing the risk of contamination-related peritonitis.

[0112] This closed cavity design serves multiple purposes. First, it prevents contamination by creating a barrier that separates the catheter from the external environment, thereby reducing the risk of infection or other forms of contamination. Second, it allows the catheter to move point-to-point in parallel with the closed cavity, allowing for smooth and controlled manipulation without the need to directly touch or handle the catheter itself. Thus, the dialysis assist system of the present invention maintains the integrity and sterility of the catheter during the CAPD procedure and enables patients with poor vision and hand-eye coordination who would otherwise be unable to connect the tubing using aseptic technique to perform CAPD independently in a safer manner with reduced risk of contamination.

[0113] The housing of the catheter receptacle securely holds the catheter in place, preventing it from becoming tangled or misplaced. This feature ensures that the user can easily locate and access the catheter during the procedure, even without visual cues. Using the disclosed system, tubing connections can be made with one hand with accurate and precise positioning, without touching the catheter.

[0114] The connection between the catheter and the pipe is guided by magnet assemblies embedded in each housing. The magnetic attraction between the different poles of these magnet assemblies allows the catheter housing to be connected to the pipe housing or the housing of the cover. If the user attempts an inaccurate combination of components (for example, coupling the second housing with the third housing of the cover), the magnets with the same polarity on these housings will repel each other. This mechanism minimizes the risk of error and acts as a safeguard against connecting inappropriate or incompatible components.

[0115] By providing a removable assistive handle within the capping device's housing, patients with limited dexterity or fine motor skills can use a less demanding twisting motion to attach and remove the cap. The handle also provides a comfortable grip and allows for easier manipulation of tubing and connectors during the CAPD procedure. The capping device features a user-friendly design for efficient and trouble-free manipulation of tubing and retainers using the tunnel system, while minimizing physical strain on the patient's hands and fingers.

[0116] It is envisioned that, as opposed to relying on machine-assisted dialysis, the use of the disclosed system will allow a greater number of patients to undergo CAPD at home, thereby reducing overall treatment costs and alleviating pressure on hospitals. Simultaneously, the system can also help peritoneal dialysis users (particularly those with end-stage renal disease) live independently and regain quality of life.

[0117] Furthermore, the disclosed system is versatile and can be used in any environment, without the need for a flat surface. Since the various components can be 3D-printed, the manufacturing cost is relatively low; furthermore, it is durable and requires minimal maintenance.

[0118] Examples

[0119] A study was conducted to evaluate the efficacy and safety of using the dialysis assist system of the present disclosure over a 2-year span. New CAPD patients using the Ultra bag Peritoneal Dialysis system and who achieved "high to moderate readiness" as assessed by an occupational therapist were invited to participate in the randomized controlled trial.

[0120] A total of 26 patients were recruited and randomly assigned to two groups: the intervention group (13 subjects) used the system in the form of a CAPD bag exchange, and the control group (13 subjects) used standard care, in which treatment was continued as usual without any auxiliary devices.

[0121] The number of peritonitis episodes was compared with the number of episodes in the entire hospital (QEH center). The results are shown in Table 1 below. Over a total duration of 327 patient months, the peritonitis rate in the intervention group was significantly lower than that in the control group (0.14 versus 0.56 per patient year) (P < 0.01). The peritonitis rate in the intervention group was also lower than the overall peritonitis rate in the hospital center during the same study period, which was 0.27 per patient year.

[0122] The study report found that episodes of peritonitis identified in the intervention group were due to patients not clamping the transfer set before disconnection during bag changes, rather than due to device safety issues.

[0123] Statistics of peritonitis and contamination

[0124] Group patient months Peritonitis attack Peritonitis rate during treatment month Annual peritonitis rate comparison 150.20 7 1 episode every 22.79 patient-months 0.56 / year QEH Center 8970.28 200 1 episode every 44.85 patient-months 0.27 / year intervention 176.60 2 1 episode every 78.15 patient-months 0.14 / year

[0125] Table 1

Claims

1. A dialysis assist system, comprising: a first housing releasably engageable at least partially around a peritoneal catheter; a second housing releasably engageable about tubing inserted therein, the tubing being communicable with a peritoneal dialysis solution reservoir; wherein the first shell includes at least one first magnetic portion disposed in or on the first shell, and the second shell includes at least one second magnetic portion disposed in or on the second shell, such that when the first shell and the second shell come into proximity with each other, magnetic attraction between the first magnetic portion and the second magnetic portion aligns the peritoneal catheter with the tubing to engage with the tubing so as to define a fluid pathway between the peritoneal catheter and the tubing.

2. The dialysis assisting system according to claim 1, wherein the first magnetic portion comprises a plurality of first magnetic members, and the second magnetic portion comprises a plurality of second magnetic members.

3. A dialysis auxiliary system according to claim 2, wherein one of the magnetic components is a permanent magnet, and wherein the other magnetic component of the magnetic component is made of ferromagnetic material, and the ferromagnetic material can be attracted by the other magnetic component when it approaches the other magnetic component.

4. The dialysis auxiliary system of claim 1 , wherein the second housing is releasably engageable around a removable tube retainer to position the tubing in the second housing.

5. The dialysis auxiliary system according to claim 4, wherein the tube holder is movable along a channel defined in the second housing.

6. The dialysis auxiliary system according to claim 4 or claim 5, wherein the tube holder is rotatable in the second housing so that the tubing and the peritoneal catheter are threadably engaged at their respective ends to define the fluid pathway.

7. The dialysis auxiliary system of claim 1 , wherein the first housing comprises complementary clamping portions hingedly attached to one another for receiving the peritoneal catheter therebetween, and the second housing comprises complementary clamping portions hingedly attached to one another, wherein a channel is defined in the complementary clamping portions for receiving the tube holder.

8. The dialysis auxiliary system according to claim 7, wherein each of the complementary clamping portions of the first shell and the second shell includes at least one third magnetic portion and a fourth magnetic portion, and the at least one third magnetic portion and the fourth magnetic portion are arranged in or on the complementary clamping portions so that when the clamping portions become close to each other, the magnetic attraction between the third magnetic portion and the fourth magnetic portion pushes the clamping portions into engagement around the catheter or the tube holder respectively received in the clamping portions.

9. The dialysis assisting system according to claim 8, wherein the third magnetic portion comprises a plurality of third magnetic members, and the fourth magnetic portion comprises a plurality of fourth magnetic members.

10. The dialysis assisting system according to claim 9, wherein one of the magnetic members is a permanent magnet, and wherein the other magnetic member is made of a ferromagnetic material that can be attracted by the other magnetic member when the ferromagnetic material approaches the other magnetic member.

11. The dialysis aid system according to any one of claims 7 to 10, wherein cross-sections of the complementary clamping parts together define a ring when the complementary clamping parts are moved towards each other.

12. The dialysis assisting system according to claim 1 , further comprising a capping device for reversibly capping and uncapping the end of the peritoneal catheter, wherein the capping device comprises: a handle engageable about the lid; a third housing engageable about the handle; wherein the third housing includes at least one fifth magnetic portion disposed in or on the third housing such that when the first housing and the third housing come into proximity with each other, magnetic attraction between the first magnetic portion and the fifth magnetic portion causes the peritoneal catheter to engage with the handle of the capping device.

13. The dialysis assisting system according to claim 12, wherein the first magnetic portion comprises a plurality of first magnetic members, and the fifth magnetic portion comprises a plurality of fifth magnetic members.

14. The dialysis assisting system according to claim 13, wherein one of the magnetic members is a permanent magnet, and wherein the other magnetic member is made of a ferromagnetic material that can be attracted by the other magnetic member when the ferromagnetic material approaches the other magnetic member.

15. The dialysis auxiliary system of claim 12, wherein the third housing comprises complementary clamping portions hingedly attached to one another, wherein a channel is defined in the complementary clamping portions to receive the handle of the capping device.

16. The dialysis assisting system of claim 15 , wherein each of the complementary clamping portions of the third housing comprises at least one sixth magnetic portion and a seventh magnetic portion, the at least one sixth magnetic portion and the seventh magnetic portion being disposed in or on the complementary clamping portions such that when the clamping portions come into proximity with each other, the magnetic attraction between the sixth magnetic portion and the seventh magnetic portion pushes the clamping portions into engagement around the handle received in the clamping portions.

17. The dialysis assisting system according to claim 16, wherein the sixth magnetic portion comprises a plurality of sixth magnetic members, and the seventh magnetic portion comprises a plurality of seventh magnetic members.

18. The dialysis assisting system according to claim 17, wherein one of the magnetic members is a permanent magnet, and wherein the other magnetic member is made of a ferromagnetic material that can be attracted by the other magnetic member when the ferromagnetic material approaches the other magnetic member.

19. The dialysis auxiliary system according to any one of claims 15 to 18, wherein when the complementary clamping parts of the third housing are moved towards each other, cross-sections of the complementary clamping parts together define a ring.

20. The dialysis auxiliary system according to claim 12, wherein the handle of the covering device is movable along a channel in the third housing.

21. The dialysis assisting system according to claim 12, wherein the handle of the capping device is rotatable within the third housing to cap or uncapping the peritoneal catheter.

22. The dialysis assist system of claim 12, wherein the handle comprises a cap engaging end and an end having a configuration for user engagement therewith.

23. The dialysis assisting system according to claim 12, wherein the first shell, the second shell, and the third shell are provided in different colors.

24. A method of providing assisted peritoneal dialysis using the dialysis assist system of claim 1, the method comprising: (a) engaging one end of a peritoneal catheter with the first housing; (b) coupling the end of the tubing in communication with the peritoneal dialysis solution to the second housing; (c) moving the first housing and the second housing toward and toward each other to couple the end of the peritoneal catheter with the end of the tubing for the peritoneal dialysis solution, thereby defining a fluid pathway between the peritoneal catheter and the tubing.

25. The method of claim 24, further comprising, prior to step (a), removing a cap from the end of the peritoneal catheter by: - coupling said first housing to said third housing of said capping device of claim 12; and - rotating the handle of the capping device within the third housing to remove the cap.

26. The method of claim 24, further comprising: - placing a new cap in the handle of the capping device, the handle being housed in the third housing according to claim 12; - bringing the first housing and the third housing closer to each other; - Rotating the handle of the capping device to attach the new cap to the end of the peritoneal catheter.

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