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Design of Wearable Dialysis Unit

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 Design of Wearable Dialysis Unit

Neela Rajhans1, Vicky Sardar2, Atul Sajgure3

1
Professor, Department of Production Engineering and Industrial Management,
College of Engineering, Pune
2 Research Associate, Department of Production Engineering and Industrial Management

College of Engineering Pune

3 Nephrologist, Sahyadri Speciality Hospital,

Deccan Gymkhana, Pune

Abstract. Patients with kidney failure receives either surgery or dialysis from
machines so that their kidneys can function normally. The dialysis membrane
used, clears the blood of waste products such as urea, phosphorus and creatinine.
The device also helps in removal of excess salt and water from blood. In existing
hemodialysis machines about 120 litre of dialysate is needed for blood cleansing.
This makes the entire dialysis unit bulky and demands a constant supervision
from the experts. Portable hemodialysis allows a handy portable or wearable sys-
tem. The main focus of wearable dialysis unit is to reduce the size of the pump
so that it can be worn. Adsorption filtering is a promising alternative for blood
purification by use of sorption material and catalytic processes. The unit can be
used to provide constant dialysis throughout the day or at least for the whole night
so that the patient can himself be able to follow the dialysis at home. The unit
concentrates on reduction in pressure of the pump. Also there should be provision
of an excess storage with a capacity of 200-250 ml to filter out toxic waste from
body. The study aims to achieve handy home hemodialysis device to ensure an
increase in mobility and employability which will result in less nursing and re-
duced healthcare costs.

Keywords: Hemodialysis · Dialysate · Wearable

1 Introduction
The kidneys are a pair of organs, each about the size of a fist, located on either side of
the spine. They are mainly responsible for purifying blood by removing waste and ex-
cess fluid from our body. When the kidneys fail to work properly, dialysis is used to
perform the function of the kidneys. Dialysis is an artificial way of cleaning our blood
by a treatment that filters and purifies the blood using a machine. Dialysis has been
used since 1940 to treat people with kidney problems. Normally functioning kidneys
prevent accumulation of extra water, waste, and other impurities in the body. They also
help to control blood pressure and regulate the levels of chemicals such as sodium, or
salt, and potassium in the blood. They even activate a form of vitamin D that improves
the absorption of calcium. When kidneys cannot perform these functions due to disease
or injury, dialysis can help keep the body running as normally as possible. Without
dialysis, salts and other waste products will accumulate in the blood and are harmful to
the body. However, dialysis is not a cure for kidney disease or other problems affecting
the kidneys but it is a temporary solution. There are two different types of dialysis:

1.1 Hemodialysis

Hemodialysis is the most common type of dialysis. It uses an artificial kidney, known
as a hemodialyzer, to remove waste and chemicals from the blood. To get the blood to
flow to the artificial kidney, the doctor surgically creates a vascular access, or an en-
trance point, into the blood vessels. This vascular access allows a larger amount of
blood to flow through the body during hemodialysis treatment. This means more blood
can be filtered and purified.

Fig. 1. Working nomenclature of a Dialysis unit

In hemodialysis, the patient's blood is pumped through the blood compartment of a

dialyzer as shown in figure 1, exposing it to a partially permeable membrane. The dia-
lyzer is composed of thousands of tiny hollow synthetic fibers. The fiber wall acts as
the semipermeable membrane. Blood flows through the fibers, dialysis solution flows
around the fibers, and water and wastes move between these two solutions. The counter-
current flow of the blood and dialysate maximizes the concentration gradient of solutes
between the blood and dialysate, which helps to remove more urea and creatinine from
the blood. The concentrations of solutes (for example potassium, phosphorus, and urea)
are undesirably high in the blood, but low or absent in the dialysis solution, and constant
replacement of the dialysate ensures that the concentration of undesired solutes is kept
low on this side of the membrane. The dialysis solution has levels of minerals like po-
tassium and calcium that are similar to their natural concentration in healthy blood. For
another solute, bicarbonate, dialysis solution level is set at a slightly higher level than
in normal blood, to encourage diffusion of bicarbonate into the blood. It acts as a pH
buffer to neutralize the metabolic acidosis that is often present in patients. The levels
of the components of dialysate are typically prescribed by a nephrologist according to
the needs of the individual patient. The cleansed blood is then returned via the circuit
back to the body. Ultrafiltration occurs by increasing the hydrostatic pressure across the
dialyzer membrane. Hemodialysis treatments usually last three to five hours. The treat-
ment is typically needed three times per week. However, hemodialysis treatment can
also be done in shorter, more frequent sessions. Most hemodialysis treatments are done
at a hospital, doctor's office, or dialysis center. The length of treatment depends on your
body size and the amount of waste in your body.

Fig. 2. Vascular access by AV fistula

The two types of vascular access designed for long-term dialysis treatments are an ar-
teriovenous (AV) fistula, which connects an artery and a vein (figure 2) and an AV
graft, which is a looped tube (figure 3). For short-term use, a catheter may be inserted
into the large vein in your neck.

Fig. 2. Vascular access by AV Graft

Haemodialysis may be recommended for people who are unable to carry out peritoneal
dialysis themselves, such as those who are visually impaired, have dementia or are in a
poor state of health.

1.2 Peritoneal Dialysis

Peritoneal dialysis involves surgery to implant a catheter into the belly area. During
treatment, especially during sleeping time, a fluid called dialysate flows into the abdo-
men (figure 3).

Fig. 3. Peritoneal Dialysis process

As soon as the dialysate draws waste out of the bloodstream, it is drained from abdo-
men. There are different types of peritoneal dialysis, but the main ones are continuous
ambulatory peritoneal dialysis and continuous cycler-assisted peritoneal dialysis. In
continuous ambulatory peritoneal dialysis, abdomen is filled and drained multiple times
each day. Continuous cycler-assisted peritoneal dialysis, uses a machine to cycle the
fluid in and out of abdomen. Peritoneal dialysis may be recommended for children with
age two years or younger, people who still have some limited kidney function or adults
who don't have other serious health conditions, such as heart disease or cancer.

2 Literature Review
Studies suggests that sorbent systems contribute to the objective of a wearable artificial
kidney for chronic kidney disease [1]. Modern conventional dialysis has improved di-
alysis prescription and delivery but it promises little incremental survival benefit for
long-term dialysis patients [2]. The efficiency of Hemodialysis (HD) can be improved
by increasing blood and dialysate flowrates, the dialyzer size and surface area, and by
increasing the duration and frequency of dialysis sessions. Home HD, where short daily
or long slow nocturnal HD sessions can conveniently be performed, provides an excel-
lent choice for quality of life improvement and reduction in morbidity and mortality.
Recent advancements have resulted in efficient implementation of adsorption, diffusion
and/or convection principles using adsorption HD and hemofiltration aiming to achieve
optimum HD [3]. Water soluble middle molecule clearances can be increased by adding
convection to standard diffusion and switching from low-flux to high-flux dialyzer
membranes. Moving up to super flux membranes does not appear to add any further
clearance advantages. Increasing the complexity and cost of the extracorporeal circuit
by adding adsorbents helps in additional removal of organic and protein-bound toxins.
However, due to the bio-incompatibility of adsorption columns, these systems often
require separation of the cellular elements of blood to achieve the benefit of increased
protein bound toxin clearances or their use may be limited to regeneration of dialysate
and or ultrafiltrate [4]. In certain dialysis patient subpopulations, the results of random-
ized clinical trials suggest that use of dialyzer containing high-flux membranes provides
an added advantage over hemodialysis. The extent to which this advantage is achieved
might also depend on how the dialyzer is used, with application in convective therapies
such as hemodiafiltration. Hemodiafiltration proves superior to diffusive therapies such
as hemodialysis. This possibility is right now the subject of several large clinical trials
[5]. Although the risks from reprocessing dialyzers have yet to be fully explored, reuse
can be done safely if it is performed with full compliance to Association for the Ad-
vancement of Medical Instrumentation (AAMI) standards. An increase in dialyzer
waste volume with conversion to single use was observed. However, there was an on-
going initiative to improve the efficiency of medical waste disposal in hemodialysis
facilities during the period of converting to single use. The quality initiative minimized
the effect of additional medical waste from discarded dialyzers. Reprocessing of dia-
lyzers also has associated waste that can be avoided with single use [6]. In order to
remove toxic substances from the blood adsorbents such as charcoal/carbon can be used
effectively [7].

2.1 Problems associated with existing Dialysis Unit

• Dialysis patients have to spend hours tethered to a machine, which is strenuous
and painful.
• The procedure usually involves using a dialysis machine three times a week,
with each session usually lasting about four hours. This calls for planning daily
activities around these sessions.
• The sessions are often carried out in a dialysis clinic, so patients may need to
travel regularly for treatment.
• Diet and the amount of fluid to drink needs to be restricted. Many people re-
ceiving haemodialysis have to avoid certain foods and are usually advised not
to drink more than a couple of cups of fluid a day.
• With long-term dialysis treatments there is a risk of developing other medical
conditions, including amyloidosis. This disease can occur when amyloid pro-
teins produced in bone marrow build up in the kidneys, liver, heart, and other
organs. This usually causes joint pain, stiffness, and swelling.
• Existing dialysis unit utilizes 120 liters of dialysate for blood cleansing. This
makes the unit bulky and the process becomes extremely complicate to moni-
tor.
 • Major disadvantage of peritoneal dialysis is that there is a risk of developing
peritonitis (infection of the thin membrane that lines the abdomen).
• Dialysis fluid used in Peritoneal dialysis can cause a reduction in protein lev-
els, which may lead to a lack of energy and, in some cases, malnutrition.

Thus, there is a need to develop a miniature kidney unit that can efficiently perform the
function of existing dialysis unit with reduction in complexity of processes and ease of
operations involved.

3 Methodology
Current hemodialysis machines utilize about 120 liter of dialysate for blood cleansing.
This increases the complexity for miniaturization. A normal patient's water volume is
around 40 liters. In the standard hemodialysis, the dialysate volume is 3 times the pa-
tient’s water volume. In sorbent dialysis, the sorbent side dialysate volume is generally
6 liters or less. Sorbent compounds are chemicals that absorb other chemicals. With the
use of sorbent column regeneration of dialysate is possible. It helps in removing uremic
toxins from dialysate, while replenishing other beneficial chemicals. Using sorbents for
continuous regeneration of dialysate, a miniature artificial kidney unit can be devel-
oped. With the application of nanosorbents only 100 ml of dialysate is needed. Thus,
the sorbent system can be very small allowing a handy portable or wearable system.
Sorbent dialysis is an innovative technology that has been used for over 35 years and is
safe. Sorbent dialysis therapy has evolved greatly through the years. Many trials of
simple-to-use sorbent system for home hemodialysis has been developed. With the
proven significance of sorbent compounds in dialysis, combinations of sorbent technol-
ogy with a pressure restricted blood pump have been developed. Based on the same
principle, the Allient Sorbent Hemodialysis System (Renal Solutions Inc; Warrendale,
Pennsylvania) was developed.
Fig. 4. Sorbent column by Allient Sorbent Hemodialysis System (Renal Solutions Inc; Warren-
dale, Pennsyl-vania)

Activated carbon and purification layer (figure 4) removes organic compounds, middle
molecules, uric acids, creatinine, chloramine oxidants, and heavy metals. Studies have
indicated that all organic uremic toxins are removed by the activated carbon, with the
exception of urea. Any carbon column which binds creatinine effectively in the state of
urea will certainly bind all of these other drugs or uremic substances, such as uric acid.
The urease layer actually binds nothing but converts urea to ammonium and carbonate.
In the next layer, zirconium phosphate is loaded with hydrogen and sodium, and these
are released in exchange for binding of ammonium, calcium, magnesium, potassium,
and other metals. The hydrogen binds with the carbonate, producing CO2. The final
layer of zirconium oxide and zirconium carbonate binds phosphate, fluoride, and heavy
metals and releases acetate and bicarbonate. In the newer sorbent cartridges developed
by Renal Solutions for the Allient system, the output is principally bicarbonate rather
than acetate [8]. The design of sorbent cartridges should consider following parameters:
• Duration of treatments specially in the case of Patients with low Blood Urea
Nitrogen (BUN) level.
• Range of Urea Nitrogen Binding in grams.
• Dialysate flow rate in ml/min.
• The amount of sodium release, which is governed by- Volume or size of pa-
tient and BUN levels in the patient. Studies indicates that higher the volume
of the patient greater the sodium release and with higher BUN levels there is
less sodium release.

3.1 Performance Considerations for Selecting a Dialyzer [9]

3.1.1 Solute Removal

Solute removal in hemodialysis occurs through a combination of diffusion, convection,

and adsorption. The uremic solutes removed by hemodialysis are divided into three
main categories: 1) small water-soluble compounds such as urea with an upper molec-
ular weight of < 500 Da that can be removed with any dialysis membrane by diffusion,
2) the larger middle molecular weight molecules (500 – 15,000 Da) which can only be
removed through dialyzer membranes with enhanced transport capacity and large
enough pores (high flux), and 3) protein-bound molecules, mostly with a molecular
weight of 500 Da, but larger and more difficult to remove because of being bound to
proteins. Convective separation of solutes and low molecular weight proteins from
large serum proteins and blood elements is achieved with high flux dialyzers through
increased porosity and efficiency of mass transfer. A moderate level of protein adsorp-
tion combined with the ability to bind protein-bound uremic toxins appears to be rec-
ommended features in a membrane.

3.1.2 Clearance
Clearance may be considered the most important characteristic of a dialyzer because it
is a critical factor in determining the dialysis prescription. Urea clearance is the most
commonly used measure, since it is used to calculate the dialysis dose. Phosphate clear-
ance and uric acid clearances are not always reported but can be helpful when treating
significantly high phosphate or uric acid levels. Phosphate being an intracellular ion,
using a dialyzer with a high phosphate clearance can cause the plasma value to decrease
rapidly without a major impact on its total removal.

3.1.3 Back filtration

Back filtration almost never occurs in low flux dialysis, and its occurrence during high
flux treatments depends on the transmembrane pressure used. This is a crucial safety
concern because any contamination of dialysate or wash-out from the membrane can
reach the blood side. Forward and backfiltration coefficients are different in vitro and
even more so in vivo because of the protein layer in the blood compartment and the
structure of the membrane. Additionally, correcting an inter-dialytic weight gain of
more than 5 kg within a dialysis session of less than 3 hours with high flux dialysis
could lead to a significant increase in the risk for hypotension, especially in patients
with poor cardiac function or autonomic neuropathy.

3.1.4 Dialyzer size and blood flow rate

Research suggests using basic principles of kinetic modeling while incorporating any
needed adjustments to improve clearance, such as extending treatment time, increasing
dialysate flow rate, increasing blood flow rate, or moving to a larger dialyzer.

3.1.5 Membranes and pore size of fibers

High Performance Membranes (HPM) have been developed for advanced level of per-
formance. The HPM should be biocompatible, should have effective clearance of target
solutes and the pore size must be larger than conventional hemodialysis membranes,
thus providing the removal of protein-bound uremic toxins and middle to large molec-
ular-weight solutes.

3.2 Design constraints for Wearable Dialysis Unit

Studies lists out the benefits of synthetic high-flux membranes, but individual patient
needs should be factored into dialyzer selection. With performance parameters in mind,
one should always consider the optimal dialyzer based on:
• the patient’s physique
• years on dialysis
• tolerance to treatment time
• tolerance to blood and dialysate flow rates residual renal function
• sufficiency of vascular access
With the development of smaller, more compact dialyzers, the provider can save space
and storage costs, while producing less waste and creating less of a burden on the user
and environment. The manufacture of smaller dialyzers requires the use of less petro-
leum which is better for the environment, along with the use of plastics from degradable
polymers instead of conventional oil-based polymers such as polycarbonate, thus con-
tributing to cleaner waste disposal. The elimination of toxic materials in dialyzers leads
to safer hemodialysis waste disposal.
The focus now should be on designing a dialysis unit that can fit on a belt which hangs
around the torso or can be carried around like a backpack.

3.3 Components of Wearable Dialysis Unit

Fig. 5. Schematic Diagram of Wearable Dialysis Unit

3.3.1 Peristaltic Pump

In peristaltic pump design, the tubing is the only material in contact with the medium
to be pumped and can be quickly changed in preparation for new fluids. Pump will be
with minimal shearing forces. The flow rate of pump ranges from 50 to 250 ml/min and
a maximum differential pressure of 2 bar. Pump in consideration, incorporates a spring
loaded rotor. The spring loaded rotor prevents high pressure from occurring in the tub-
ing. The pump can be integrated into the dialysis control system through an interface
or analog signal interface to achieve automatic intelligent dialysis solution without hu-
man intervention. When the blood pressure is too high, the pump will relieve the pres-
sure automatically. Disposable tubing can be used for dialysate perfusion, drainage and
blood pumping in order to prevent the cross-infection.

3.3.2 Ultra-Filtrate
This chamber incorporates a hemodiafiltration technique which uses a paired filtration
dialysis-charcoal to regenerate the ultrafiltrate. This ultrafiltrate is used as the replace-
ment fluid. Charcoal regenerates the ultrafiltrate and transforms it into a physiological
solution. This solution will have a normal electrolyte composition, calcium, bicar-
bonate, and glucose. The majority of both middle and large molecule uremic toxins are
eliminated. The regeneration will be done in such a way that replacement fluid is bac-
teria and endotoxin free.

3.3.3 Hemofilter
Solute movement with hemofiltration is governed by convection rather than by diffu-
sion. Hence in hemofiltration, dialysate is not required. Thus the size of the unit can be
reduced. With the Hemofilter in application, a positive hydrostatic pressure drives wa-
ter and solutes across the filter membrane from the blood compartment to the filtrate
compartment, from which it is drained. Solutes, both small and large, get dragged
through the membrane at a similar rate by the flow of water that has been engendered
by the hydrostatic pressure. Thus convection overcomes the reduced removal rate of
larger solutes (due to their slow speed of diffusion) seen in hemodialysis.

3.3.4 Storage bag

An excess storage bag is provided with a capacity of 200-250 ml to filter out toxic waste
from body.

3.4 Working Principle

In this design (figure 5) the concentration is on blood flow via a peristaltic pump and
two filtrates. Blood flow to the filter is achieved via a peristaltic pump. The first filter
will be parallel to the design used in standard dialyzer (ultra filtrate). The second filtrate
will purely serve the adsorption purpose (hemofilter) containing high-flux membranes.
To avoid the constant addition of purified water to the device a filtration unit can be
incorporated with the design. Thus the water can be cleansed and recirculated into the
machine.
The unit reproduces the ultrafiltrate and due to convection there is no need of dialysate.
The main objective of this unit to reduce the size of the pump so that it can be wearable
is thus accomplished. With this design, dialysis procedure can be carried out for the
whole night and with less complications. With this unit the patient can himself carry
out the dialysis at home.

4 Conclusion
Handy portable home hemodialysis device with traditional vascular access makes dial-
ysis easy to carry out anywhere, allowing use for longer periods. The unit can be min-
iaturized by reducing the size of peristaltic pump and absorption filter. Use of convec-
tion for solute movement results in dialysate free design. Use of nanosorbents can help
in reducing the ultrafiltrate size. With wearable dialysis unit, blood cleansing can be
achieved while being mobile, at home or at work. Thus, less nursing and medical care
will be needed thereby reducing healthcare costs. The design promotes better health
condition and life expectancy.
 5 Future scope
Safety measures can be achieved by use of built in sensors for monitoring and auto-
mated control. Use of Internet of Things (IoT) can provide remote monitoring via web
or mobile devices.

6 References
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and End-Stage Renal Disease in the United States, Bethesda, National Institutes of Health,
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9. A Clinical Update on Dialyzer Membranes, https://www.kidney.org/sites/default/files/02-10-
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