Dialysis machine tubing protection

Tubing protectors, systems including tubing protection, and methods for protecting tubing, are disclosed, such as for protecting tubing connected between a patient and a dialysis machine (e.g., peritoneal dialysis machine) during a dialysis treatment. A tubing protector may include a tubing sheath attachable to a patient. The sheath may include a first portion for receiving and protecting a length of tubing extendible in the sheath, such as to minimize collapse, kinking, blockage, or combinations thereof, along the length of the tubing. A second portion may comprise a flexible material and enclose the first portion. The first portion may comprise a resilient material, which allows for movement in the sheath and has a strength to allow for reorientation of the tubing, while withstanding deformation of the tubing along the length. The first portion may be a coil, a plurality of rings, a woven mesh, or a solid tube, or combinations thereof.

FIELD

The disclosure generally relates to tubing protectors, systems including tubing protection, and methods for protecting tubing, for example, as used with dialysis machines and systems, and more particularly to tubing protection for tubing extending between a patient and a peritoneal dialysis machine while performing a dialysis treatment.

BACKGROUND

Dialysis machines are known for use in the treatment of renal disease and for utilizing tubing connected between the machines and patients during treatments, which may require protection to prevent or minimize collapse, kinking and/or blockage, along a length of the tubing. The two principal dialysis methods are hemodialysis (HD) and peritoneal dialysis (PD). During hemodialysis, the patient's blood is passed through a dialyzer of a hemodialysis machine while also passing dialysate through the dialyzer. A semi-permeable membrane in the dialyzer separates the blood from the dialysate within the dialyzer and allows diffusion and osmosis exchanges to take place between the dialysate and the blood stream. During peritoneal dialysis, the patient's peritoneal cavity is periodically infused with dialysate or dialysis solution. The membranous lining of the patient's peritoneum acts as a natural semi-permeable membrane that allows diffusion and osmosis exchanges to take place between the solution and the blood stream. Automated peritoneal dialysis machines, called PD cyclers, are designed to control the entire peritoneal dialysis process so that it can be performed at home, usually overnight, without clinical staff in attendance.

A dialysis machine, such as a peritoneal dialysis machine, may include one or more containers (e.g., bags) containing a fluid, e.g., a dialysate, for patient infusion. In peritoneal dialysis machines, for example, tubing as one or more fluid lines are inserted into an abdomen of a patient for flowing fresh dialysate and removing used dialysate, waste, contaminants, and excess fluid. Treatments may require several batches of fresh and used dialysate to cycle in and out of the patient's abdomen over a several hour period, often overnight. The PD cyclers may therefore perform a dialysis treatment substantially automated and unsupervised while the patient sleeps. With such treatments, for example, circumstances of the location, posture, or movement, of patients may compromise the tubing connected to them, resulting in instances of collapse, pinching or kinking, and/or blockage, of the tubing, particularly at points close to where the tubing connects to the patients.

It is with respect to these and other considerations that the present improvements may be useful.

SUMMARY

In some embodiments of the present disclosure, a tubing protector may comprise a tubing sheath. The sheath may include a first portion. The first portion may be for receiving and protecting a length of tubing extendable therein, so as to minimize collapsing, kinking, or blockage, or combinations thereof, along the length of the tubing. The sheath may include a second portion enclosing the first portion, and the second portion may comprise a flexible material. The first portion may comprise a resilient material, and the resilient material may allow for movement in the sheath and may have a strength to allow for reorientation of the tubing, while withstanding deformation of the length of the tubing.

In the embodiments described and other embodiments of the present disclosure, the tubing may further comprise a belt connected to the tubing sheath and removably attachable to a patient. The first portion may be a coil, a plurality of rings, a woven mesh, or a solid tube, or combinations thereof, such that the first portion may be extendable along the length of the tubing. The second portion may be a cover over the first portion and may be extendable along the length of the tubing. The second portion may include a slot extending along the cover and the length of the tubing. The tubing may be connectable between a patient and a peritoneal dialysis machine, and the tubing sheath may be attachable to the patient with the belt for a dialysis treatment. A tubing protector may further comprise one or more sensors configured to detect a fluid temperature, a fluid flow rate, a fluid pressure, a kink, collapse or blockage of the tubing, or patient parameters, or combinations thereof. The tubing sheath, or the belt, or both, may further comprise a connectivity component for data transmission between one or more sensors and the peritoneal dialysis machine.

In some embodiments of the present disclosure, a tubing protection system may comprise a tubing sheath surrounding a length of tubing extendable therein when connected to a patient. The sheath may be for minimizing collapsing, kinking, or blockage, or combinations thereof, along the length of the tubing. The tubing sheath may comprise a resilient material, and the resilient material may allow for movement in the sheath and may have a strength to allow for reorientation of the tubing, while withstanding deformation of the length of the tubing.

In the embodiments described and other embodiments of the present disclosure, the tubing sheath may include a coil, a plurality of rings, a woven mesh, or a solid tube, or combinations thereof. The tubing sheath may include a cover. A tubing protection system may further comprise a belt coupled to at least a portion of the tubing sheath. The belt may be removably attachable to the patient such that the tubing sheath may be positionable about the length of the tubing when attached to the patient. A tubing protection system may further comprise one or more sensors disposed on the tubing sheath, the cover, or the belt, or combinations thereof. The sensors may be configured to detect a fluid temperature, a fluid flow rate, a fluid pressure, a kink, collapse or blockage of the tubing, or patient parameters, or combinations thereof. The cover may include a slot extending along the length of the tubing. A tubing protection system may further comprise a connectivity component for data transmission to a remote device.

In some embodiments of the present disclosure, a method of protecting tubing connecting a patient to a peritoneal dialysis machine during a treatment may comprise receiving a length of the tubing closest to the patient in a tubing sheath. The sheath may be configured to minimize collapsing, kinking, or blockage, or combinations thereof, along the length of the tubing. The method may include connecting the tubing to the patient for performing the treatment with the peritoneal dialysis machine. The method may include attaching a belt around the patient to secure the tubing sheath and the length of the tubing received in the tubing sheath. The belt may be coupled to the tubing sheath, such that a substantially uninterrupted fluid flow may be provided through the length of the tubing between the peritoneal dialysis machine and the patient during the treatment.

In the embodiments described and other embodiments of the present disclosure, a method may further comprise detecting at least one of fluid temperature, a fluid flow rate, a fluid pressure, a kink, collapse or blockage of the tubing, or patient parameters, or combinations thereof, during the treatment. The tubing sheath may include a first portion. The first portion may comprise a resilient material and may have a strength to prevent deformation of the length of the tubing. The tubing sheath may include a second portion. The second portion may be formed of a flexible material and may enclose the first portion. The first portion may be a coil, a plurality of rings, a woven mesh, or a solid tube, or combinations thereof. The first portion may be extendable along the length of the tubing. The second portion may comprise a cover. The cover may include a slot extending along the length of the tubing.

DETAILED DESCRIPTION

The present embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which several exemplary embodiments are shown. The subject matter of the present disclosure, however, may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and willfully convey the scope of the subject matter to those skilled in the art. In the drawings, like numbers refer to like elements throughout.

As described above, in peritoneal dialysis operations, tubing is connected between a dialysis machine and a catheter in an abdomen of a patient for delivering fresh dialysate into the patient's peritoneal cavity and removing used dialysate and contaminants after a predetermined time. A patient may undergo several cycles of delivering a fresh batch of dialysate and removing the used dialysate and contaminants in a single treatment. In some embodiments, a peritoneal dialysis treatment may be performed at home, controlled by an automated peritoneal dialysis machine or cycler, and may occur overnight while a patient is sleeping, e.g., automated peritoneal dialysis (APD). In other embodiments, a peritoneal dialysis treatment may be performed manually, e.g., continuous ambulatory peritoneal dialysis (CAPD) procedures.

FIG. 1is a schematic100illustrating a patient undergoing an overnight treatment by a peritoneal dialysis system105. A dialysis machine, or PD cycler110, may monitor the fluid flow to and from a patient115. The patient115, as illustrated, may be sleeping in a substantially horizontal position. It is also understood that the patient115may be sitting up and awake during treatment. Tubing120, e.g., a patient fluid line, of the dialysis system105may extend between the PD cycler110and a catheter125extending from an abdomen (e.g., peritoneal cavity) of the patient115. One or more dialysate bags106may be connected to the PD cycler110, for providing fresh dialysate to the patient. The patient fluid line and the dialysate bags may be connected to each other and additional tubing via a cassette or cartridge. In embodiments, a patient line may be connected to the cartridge. The patient line may be connectable to the patient's abdomen (e.g., peritoneal cavity) via the catheter and the dialysis machine may be used to pass dialysate back and forth between the cartridge and the patient's peritoneal cavity during use with pump heads situated on the machine.

Positioning of the tubing120during a treatment may be subject to how and where the patient may be sleeping and/or sitting. The tubing120may become kinked, or may collapse, or become otherwise blocked anywhere along the length of the tubing between the patient115and the PD cycler110. Specifically, tubing120may kink, collapse, and/or block near the patient115, e.g., at the catheter125, and/or where the tubing extends beyond a patient's sleeping area, e.g., off an edge of a bed, or chair, indicated at reference numeral130. The patient115may inadvertently kink, collapse, and/or otherwise block the tubing during normal shifting and/or movement while asleep.

In response to detecting a potential kink, collapse, and/or blockage of the tubing120, the PD cycler110may automatically alert, alarm, and/or abort a treatment if fluid cannot freely flow between the patient115and the PD cycler110. The PD cycler110may detect the kinked or collapsed tubing to provide warnings to the patient prior to stopping treatment, which may wake the patient so that the tubing can be checked and readjusted as needed to continue the treatment. However, these warnings in the form of alerts and alarms may result in a patient having a restless evening, negating the advantages of performing the dialysis treatment overnight.

Referring now toFIGS. 2A-2B, and 3, exemplary embodiments of a tubing protector200,300of the present disclosure are described, which may be utilized by a patient to minimize kinking, collapse, or blocking, or combinations thereof, during a treatment, such as a dialysis treatment with a peritoneal dialysis machine.

As shown inFIGS. 2A-2B, the tubing protector200may be attachable to a patient around a patient line or tubing, e.g., tubing120. The tubing protector200may include a tubing sheath205. The sheath205may include a proximal end205aand a distal end205band may be extendable a distance “Ds”. The distance Ds of the sheath205may be up to a length of the tubing120, which may include an entire length of the tubing, e.g., so that the patient line may be completely enclosed by the tubing protector200. In some embodiments, the distance Ds of the sheath205may be less than an entire length of the tubing120. The sheath205may be formed as a tube, e.g., having a hollow body to define a cavity210, so that the tubing120may be extendable through the cavity210from the patient at the proximal end205aof the sheath205and through the distal end205bof the sheath205to the PD cycler110. The sheath205may be substantially cylindrical, although it is envisioned that the sheath205may be any shape to enclose the tubing120.

In some embodiments, the proximal end205aof the sheath205may be a larger diameter than a diameter of the distal end205b. The proximal end205aof the sheath205may transition from a larger diameter to a smaller diameter, e.g., may be formed as a frustoconical portion. The frustoconical portion may extend a distance along the sheath away from the patient to accommodate the length of the catheter125extending from the abdomen (e.g., peritoneal cavity) of the patient115, although in other embodiments may be any distance to receive the tubing120and the catheter125. It may be advantageous to have a larger proximal end205ato accommodate any additional space needed around the catheter125extending out of the patient's abdomen. For example, the catheter125and/or the skin immediately surrounding the area of insertion may be sensitive and/or susceptible to infection. The larger proximal end205bmay minimize patient discomfort and/or infections by covering over the catheter125and tubing120, and the area of insertion, and tapering to a smaller diameter away from the catheter125. Additionally, and/or alternatively, the larger proximal end205amay be sized to accommodate a belt215.

In some embodiments, the sheath205may include a first portion220and a second portion225. The first portion220may be formed to protect the tubing120to minimize or prevent kinking, collapse, or blockage, or combinations thereof, along the length of the tubing. In some embodiments, the first portion220may comprise a resilient material; the material being strong enough so that when the tubing120is received in the cavity210, the tubing120may be sufficiently supported when a patient readjusts and/or moves while sleeping during a treatment, so that fluid flow (e.g., fresh dialysate, used dialysate, waste, contaminants, excess fluid, etc.) is uninterrupted or substantially uninterrupted. An uninterrupted or substantially uninterrupted fluid flow may minimize or eliminate alerts and/or alarms, so that the patient may not be woken up to attend to the alert and/or alarm. The resilient material of the first portion220may be of a material and configured within the sheath to accommodate movements of the patient, and consequential reorienting of the tubing, while still reinforcing the sheath to protect and/or minimize the tubing against deformation, such as blocking, kinking and/or collapse.

The tubing120may be connected to the catheter125and extend from the patient in any orientation, e.g., substantially perpendicular, or following along the abdomen of the patient in any direction. For example, sheath205is depicted inFIGS. 2A-2Bas being substantially straight, but may have one or more bends or twists, or the like, along the distance Ds, to orient the tubing as desired for comfort and accessibility, while still providing protection for the length of the tubing extending along and within the sheath. In embodiments following along the abdomen, the sheath may have a bend in close proximity to the connection of the tubing to the patient in order to orient the sheath in a configuration that is more parallel (i.e., presents a lower profile) to the torso of the patient. In some embodiments, the tubing120may be affixed to a stationary point a distance from the patient, e.g., a patient's bed or chair, to encourage a desired orientation of the tubing120. Throughout the treatment, the tubing120may reorient itself as the patient moves while asleep, and the first portion220may be resilient and strong enough to accommodate this reorientation based on patient movement, but may not direct the orientation of the tubing. For example, if the patient moves so that the tubing is situated underneath a body part, the first portion220may be resilient enough to allow for this patient movement, and may also be strong enough so as to not deform (e.g., kink, collapse, and/or block) under the patient's weight.

In embodiments, the first portion220may be formed of a coil, or a spring. The coil may extend from the proximal end205ato the distal end205bof the sheath205, and may define the cavity210. The coil may extend all the way to the proximal end205ato a surface of the proximal end205that is in proximity to or in contact with the patient abdomen and around the catheter125. The coil may reinforce, or further reinforce, the proximal end205in this regard. Alternatively, the coil may terminate in the sheath prior to reaching proximal end205and the first portion220may be continued from the termination of the coil to the proximal end205with a section of fabric, or other material, that is softer than the coil reinforced segment of the first portion, e.g., to provide a comfortable interface with the patient. If the coil extends to the proximal end205, the diameter of the coil at the proximal end205may be made larger, or made to gradually become larger, compared to the diameter along other segments of the first portion220. This may be done to accommodate a possible larger diameter of the catheter125at the proximal end205than, e.g., tubing120at other segments of the first portion. Alternatively, the coil diameter may be sized the same along all, or substantially all, of the length of the first portion in order to provide clearance for the largest diameter portion of the catheter and tubing along the first portion. In some embodiments, the first portion220may be a plurality of rings, extending from the proximal end205ato the distal end205bof the sheath205, to define the cavity210. A coil or a plurality of rings as the first portion may be made resilient by the material used (e.g., a memory material, such as nitinol) and how the material is configured (e.g., width and pitch of coil or rings) in the first portion of the sheath. The coil or rings may be configured for expanding and/or contracting from each other, in a direction along a longitudinal axis of the sheath and substantially parallel to the tubing120.

In some embodiments, the first portion may be a woven mesh, or a solid tube, or both, which is resilient. The resiliency of the mesh or solid tube, e.g., the degree of flexibility/rigidity of the mesh or tube across a range of values and measures, may be varied according to the requirements of the specific application of the tubing protector, as may be understood in the art, e.g., by varying the material, the weave, the pitch of coil, etc. The first portion220may be formed of metals, metal alloys, composites, or any material that maintains its shape, or combinations thereof. The woven mesh as the first portion may be a plurality of woven wires forming a pattern. The wires and formed pattern may allow for elastic bending or other movement, which may allow the sheath205to respond to patient movement during a treatment. Other reinforcing options are contemplated, as an alternative or complement to a mesh or coil. For example, in some embodiments, the first portion may be a linear hollow cylinder (e.g., balloon), which is inflatable along its length. The cylinder may be uniform along the length, or may include inflatable and non-inflatable chambers, so as to allow for areas of varying flexibility/rigidity.

In some embodiments, the second portion225may be formed as a cover to enclose the first portion220. The second portion225may be separate from the first portion220, although it is also envisioned that the first and second portions220,225may be integrally formed. For example, the first portion220may be embedded in the second portion225. It is understood that the second portion225(e.g., cover) may enclose the first portion by extending over the first portion220, by integrally including the first portion220, or both.

The second portion225may comprise a flexible material, such as a soft material, a fabric, or any washable material. It may be advantageous to use a soft material for the second portion225, particularly at the proximal end205aof the sheath205, which may directly contact the patient. A cover as the second portion225may be padded, e.g., may be softer, in some portions, such as the proximal end205a, so that contact with the patient may not disrupt a sleep cycle of the patient or irritate the skin the of the patient. For example, padding may be included so that the tubing protector200may be more “huggable” along the patient's abdomen.

Additionally, a machine-washable material may allow for the tubing sheath205to be cleaned between uses so that the tubing protector200may be reusable and minimize potential infections through reuse. In other embodiments, the tubing protector200, or portions of the tubing protector200, may be single-use, and disposable after each treatment.

In some embodiments, the sheath205may include a slot230, extending the distance Ds from the proximal end205ato the distal end205bof the sheath205and along a length of the tubing. The slot230may be an opening of the sheath205, e.g., an opening in a cover extending along the longitudinal axis of the sheath, so that the catheter125and the tubing120may be quickly and easily inserted in the cavity210of the sheath205without having to thread the sheath205along the entire tubing120for positioning in proximity to the patient. It is understood that the slot230may be optional, and that in some embodiments, the tubing protector200may slide over the tubing120for positioning in proximity to the patient. The slot230may optionally be closable by sealing mechanisms, such as clips, buttons, snaps, Velcro®, or combinations thereof, for repeatable opening and closing of the slot230. The slot230may also optionally be overlapping edges of the second portion, so that the tubing120may be slid between the edges into the cavity210. It may be advantageous to be able to close the slot230so that the tubing230may be retained in the cavity210of the sheath205.

The sheath205may be coupled to a belt215, to removably attach the tubing protector200to a patient for use during a treatment. The belt215may extend from the proximal end205aof the sheath205. In some embodiments, a first side215aof the belt215may extend from a first side235of the proximal end205aof the sheath205to an end245. A second side215bof the belt215may extend from a second side240of the proximal end205bof the sheath205to an end250. In other embodiments, the belt215may extend from one side235,240, and attach directly to the other side235,240of the proximal end205bof the sheath205. The belt215may hold the sheath205of the tubing protector200in place in proximity to the patient's abdomen, so that fluid flow in the tubing120may be uninterrupted or substantially uninterrupted. The belt215may be wide enough to comfortably extend around the patient's abdomen and lower back without shifting while a patient is asleep. In embodiments, the belt215may be formed of a washable, soft, flexible material, and/or may be at least partially elastic, to comfortably accommodate various sizes and positioning of patients.

The first and second ends250may include attachment mechanisms255. The belt215may extend around the patient and secure to the patient by the attachment mechanisms255. The attachment mechanisms255may be any securement mechanism, including but not limited to Velcro® fasteners, snaps, buttons, ties, hook and eyes, and the like. The attachment mechanisms255may be selected for patient comfort, e.g., so that the patient may comfortably wear the tubing protector200while sleeping and/or sitting, for long periods of time. Additionally, the attachment mechanisms255may be spaced apart to accommodate different-sized patients, to secure the tubing protector against the patient's abdomen.

Referring now toFIG. 3, another exemplary embodiment of a tubing protector300in accordance with the present disclosure is shown. Similar to the tubing protector200, a sheath205having a proximal end205aand a distal end205bmay be coupled to a belt215, so that the tubing protector300may be removably attachable to a patient115. Tubing120may extend through the cavity210of the sheath205and out the distal end205bfor connection into a treatment system, such as a PD cycler (e.g., via a cassette, cartridge, and/or warmer pouch).

Optionally, the tubing protector300may further include one or more sensors360, and may be any of a temperature sensor, a fluid pressure sensor, a flow rate sensor, a conductivity sensor, a tubing kink and/or collapse sensor, a blockage sensor, a weight sensor, a video sensor, an air sensor, an air bubble sensor, a thermal imaging sensor, an electroencephalogram sensor, a motion sensor, an audio sensor, an accelerometer, or a capacitance sensor, or any combinations thereof. The sensors may be configured to detect fluid parameters, patient parameters, or both. It is appreciated that the sensors360may include sensors with varying sampling rates, including wireless sensors. Sensors360may include any type and/or design in the sheath205, and the sheath205may include any number “n” of sensors, e.g.,360a,360b, . . .360n. Enhanced monitoring of patient parameters and/or fluid flow parameters may provide notification to the patient and/or a medical professional of the progress, efficacy, and/or efficiency of the treatment performed. In some embodiments, sensors360may be disposed in the cavity210of the sheath205and/or may be disposed anywhere along the distance Ds from the proximal end205ato the distal end205bin proximity of the tubing120. The sensors360may be disposed on the first portion220and/or the second portion225of the sheath205. Sensors360may additionally and/or alternatively be disposed on the belt215.

The sheath205may include an optical sensor360afor visual detection of a fluid. In some embodiments, a light emission source365(e.g., light emitting diode (LED)), may be disposed with the optical sensor360a. The light emission source365may illuminate the fluid flowing through the tubing120for the optical sensor360ato observe fluid flowing through the tubing120, the rate of flow through the tubing, and/or to detect any changes in clarity of the fluid. For example, patients with an infection may have used dialysate fluid of a different (e.g., cloudier) clarity and/or particles in the fluid than patients without an infection, which may indicate peritonitis in the patient. More than one optical sensor360aand/or light emission source365may be placed along the length of the sheath205to detect various of the above or other conditions. The optical sensor360aand light emission source365may provide a more reliable and/or repeatable option for detecting changes in fluid. In some embodiments, the light emission source365may include a photodetector and circuitry such that upon detection of a change in clarity of fluid, the optical sensor360amay signal to the patient or medical provider, or both.

The sheath205may include a flow rate sensor360bfor detecting a rate of flow in the fluid (e.g., fresh dialysate, used dialysate, waste, contaminants, excess fluid, etc.) flowing between the patient and the treatment system (e.g., PD cycler). The flow sensor360bmay detect an obstruction, or blockage, which may change the rate of flow of the fluid through the tubing120. The flow rate sensor360bmay, e.g., detect when a fluid flow rate changes a predetermined amount, at a single point or over a predetermined sampling interval, in which case a signal may be issued to indicate a potential blockage to the patient.

A temperature sensor360cmay be disposed in or on the sheath205, which may monitor a temperature of fresh dialysate prior to flowing into the patient. Although dialysate temperature may be regulated and monitored at the PD cycler, detecting the dialysate temperature closer to entering the patient may be advantageous for temperature regulation for patient comfort and safety, and/or as a redundant check on the temperature regulation at the PD cycler.

A conductivity sensor360dmay be disposed in the sheath205to detect and/or measure a conductivity of the fluid flowing between the patient and the PD cycler, including but not limited to fresh dialysate, used dialysate, waste, contaminants, excess fluids, etc. Conductivity levels may indicate if a fluid is acceptable. For example, fresh dialysate may be monitored to ensure it is within an acceptable predetermined conductivity range prior to being delivered to the patient, to ensure it has not been contaminated or otherwise become unsuitable for patient use. Conductivity levels of used dialysate, waste, contaminants, or other excess fluids flowing out the patient may be monitored for detecting patient health. The conductivity sensor360dmay detect a change in conductivity of fluid flowing out the patient, at a single point or over a timed interval, which may indicate a potential infection, illness, or other patient parameter. A signal may be issued to indicate to the patient and/or medical professional for further evaluation.

The sensors360a,360b, . . .360nmay signal to the patient or medical provider in the form of a notification, warning, alert, and/or alarm. In some embodiments, the notification may be at the treatment system, such as the PD cycler, e.g., on a display, in a warning light, a print out, or any other visual, audible, and/or haptic signal. In some embodiments, the notification may be at the sheath205, e.g., as a visual, audible, and/or haptic signal. For example, a flow rate sensor360bmay be advantageous for manual peritoneal dialysis treatments, e.g., to provide feedback to a patient receiving treatment without a cycler by signaling to the patient via the tubing protector200,300. A temperature sensor360cmay be similarly advantageous for manual peritoneal dialysis treatments, e.g., to provide feedback to a patient not otherwise available. The patient may adjust a treatment to achieve a desired temperature including adjusting storage of dialysate bags and/or changing the location of the dialysis treatment.

In embodiments, dialysate may be stored in containers, e.g., a flexible bag, that may be formed of a Biofine™ material and/or a polyvinyl chloride (PVC) material. Although the term “bag” is used throughout, it should be understood that a dialysate bag may be any type of container capable of holding a fluid, e.g., a dialysate. In some embodiments, a fluid container may include a container in which dry concentrates are mixed with water to generate dialysate suitable for a dialysis treatment.

In some embodiments, the sheath205may include a haptic communication component370, which may apply a force, vibration, or motion, or combinations thereof, to a patient, in response to a sensor360a,360b, . . .360ndetecting a condition that may necessitate immediately notifying the patient. For example, a sensor360may detect kinking or collapse of the tubing, or a risk of kinking or collapse. The haptic communication component370may be disposed at the proximal end205aof sheath205, so that the patient may feel a movement (e.g., force, vibration, or motion) of the haptic communication370. Haptic signals may allow the patient to readjust position, e.g., sleep position, with respect to the tubing120, and/or to readjust the position of the tubing120or the tubing sheath205, in order to minimize, resolve and/or avoid an audible alarm from the PD cycler. The ability of the patient to self-correct may advantageously improve a patient's sleep cycle during overnight treatments, as well as the sleep cycle of other persons in a vicinity of a patient receiving an overnight treatment. Alternatively, and/or additionally, haptic signals may be more reliable for alerting patients with hearing loss.

In some embodiments, the sheath205or belt215, or both, may include a connectivity component375for transmission of sensor data from the tubing protector200,300to one or more remote devices, including but not limited to a PD cycler, other dialysis machine or system, healthcare databases, mobile devices, and the like. The connectivity component375may be Bluetooth® enabled, and may include any circuitry, microprocessor, microcomputer, or other components for transmitting sensor signals and/or notifications, warnings, alerts, or alarms, or combinations thereof, between the tubing protector200,300and remote device.

While the systems and techniques described herein have been largely explained with reference to a dialysis machine, in particular, a peritoneal dialysis machine, a tubing protector may be used in connection with other types of medical treatment systems and/or machines, including any other medical treatment devices involving medical fluids such as continuous positive airway pressure (CPAP) machines. In some implementations, the machine may be configured for use in a patient's home (e.g., a home dialysis machine, home CPAP machine). The home machine may take the form of a peritoneal dialysis machine.

An exemplary method of protecting tubing connecting a patient to a treatment system, e.g., a peritoneal dialysis machine, in accordance with the present disclosure may include a tubing protector. A length of tubing, e.g., a portion of, or the entirety of, a line extending from the treatment system to a patient, may be received in a tubing sheath of the tubing protector. The portion may be closest to the patient to accommodate the tubing, and any connection of the tubing to a catheter, at an insertion point into the abdomen of the patient. The tubing sheath may be configured to minimize collapse, kinking, or blockage, or combinations thereof, along the length of the tubing received within the sheath. The tubing may be connected to the patient, e.g., via a catheter extending out of the patient's abdomen. The tubing may be connected between the treatment system (e.g., a peritoneal dialysis machine such as a PD cycler) and the patient for performing the treatment.

A belt may be attached to the patient. The belt may be coupled to the tubing sheath and may be attached to the patient by connecting around the patient (e.g., around the patient's abdomen) to secure the tubing sheath and the length of the tubing received in the tubing sheath. The tubing sheath may protect the tubing such that an uninterrupted or substantially uninterrupted fluid flow may be provided through the length of tubing in the sheath, between the treatment system and the patient, during the treatment. The tubing sheath may include a first portion comprising a resilient material. The resilient material may be of a material and formed within the sheath to accommodate movements of the patient, and consequential reorienting of the tubing, while reinforcing the sheath to protect and/or minimize against tubing deformation, such as blocking, kinking and/or collapse, or combinations thereof, along the length of the tubing. A second portion of the sheath may comprise a flexible material and enclose the first portion. In embodiments, the first portion may be a coil, a plurality of rings, a woven mesh, or a solid tube, or combinations thereof, such that the first portion is extendable along the tubing. The second portion may include a slot extending along the tubing sheath.

At least one of a fluid temperature, a fluid flow rate, a fluid pressure, a kink, collapse or blockage of the tubing, or patient parameters, or combinations thereof, may be detected during the treatment. Sensors may be disposed in the tubing sheath and/or belt for detection of desired parameters. In response to detecting a change in a desired parameter, a signal may indicate its status to the patient and/or medical professional. For example, a signal may notify, warn, alert, and/or alarm, via the tubing protector and/or the treatment system, which may indicate to the patient a need to adjust the tubing and/or other parameters for further evaluation.

As used herein, an element or operation recited in the singular and proceeded with the word “a” or “an” should be understood as not excluding plural elements or operations, unless such exclusion is explicitly recited. To the extent used in this description and in the claims, a recitation in the general form of “at least one of [a] and [b]” should be construed as disjunctive. For example, a recitation of “at least one of [a], [b], and [c]” would include [a] alone, [b] alone, [c] alone, or any combination of [a], [b], and [c].

Furthermore, references to “one embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features.