Modern dialysis machines are highly computerized, equipped with a continuous monitoring system having safety-critical parameters and possess increased hydraulic permeability to aid portable hemofiltration designs.

Advances in nanotechnology manufacturing coupled with leap in electronics and miniaturization have resulted in a new generation of wearable and portable dialysis devices, which are now revolutionizing the treatment of chronic kidney disease. This is potentially a new dawn in the treatment of kidney diseases with the advent of the first generation of wearable and portable dialysis devices, which may well play a pivotal role in treatment and quality of life for patients with end-stage kidney disease. Wearable and portable dialysis devices could potentially improve lifestyle of patients by allowing them to continue with their daily activities while undergoing dialysis, as well as by loosening or removing dietary and fluid restrictions and reducing the pill burden.

The modern dialysis machines that are now available are highly computerized, equipped with a continuous monitoring system having safety-critical parameters, including blood and dialysate flow rates, dialysis solution conductivity, temperature, and pH, as well as analysis of the dialysate checking blood leakage or presence of air. In case of any problem and if the reading is out of the normal range, it triggers an audible alarm to alert the patient, as well as the technician who is monitoring the patient.

Market Dynamics

The rising incidence of renal disorders and related conditions among the ageing population has a significant impact on the overall demand for dialysis equipment. Government reimbursement policies for dialysis procedures and high incidence of diabetes and chronic kidney diseases are other factors that drive the global dialysis products and services market. The high incidence of kidney diseases can be attributed to inactive lifestyle, stress, smoking, and alcohol consumption. The global dialysis products and services market is expected to grow at a CAGR of 5.9 percent between 2014 and 2020 with a market value estimated at USD 115,474.9 million by 2020.

The pressing need to adopt sophisticated treatment for chronic kidney diseases and rising incidence of renal disorders stimulates the demand for hemodialysis (HD) machines. Within the segment for peritoneal dialysis products, dialysates/concentrates occupy the highest market share. Surging demand for peritoneal dialysis (PD) fuels the demand for dialysates. Expansion of the segment for in-center dialysis can be attributed to the convenience in administering the course of treatment by skilled dialysis specialists in a regularized schedule. One of the major drivers of the market is the increase in the end-stage renal disease (ESRD) patient population. The increase in the global prevalence over the years indicates a significant rise in the number of patients requiring care for ESRD as well as a gradual improvement in access to treatment.

Technology Trends

Advancement of ultrafiltration and hemofiltration. The advent of dialyzers with increased hydraulic permeability led to the development of wearable and portable hemofiltration designs. However, for hemofiltration to provide effective clearance, large ultrafiltration volumes with corresponding replacement fluid are required. These technical difficulties led to the abandonment of the first generation of wearable hemofiltration devices or resulted in devices being limited to providing low volume ultrafiltration for the treatment of refractory heart failure rather than for treatment of end-stage kidney disease. More recently, a new design based on passing a plasma ultra-filtrate through a silica-based nanoclay sorbent has been developed, with the majority of plasma ultra-filtrate being returned to the patient, but some expelled to control the fluid balance.

As yet, clinical trials of this prototype have been limited to large animal studies. More work is required to refine this design and to determine the capacity of the silica-based nanoclay sorbents.

Implantable artificial kidney. Artificial kidney is one of the revolutionary inventions giving hope to chronically ill kidney patients to lead a normal life. As conventional dialysis can be performed twice or thrice in a week and involves the patient to be admitted to hospital, it is very difficult for the patient to lead a normal life. Moreover, as the process of purifying blood happens only twice or thrice a week, there is always a chance of toxin build-up in the blood and the accompanying hazards with it. Wearable artificial kidney thereby helps the patient to avail the benefits of dialysis every day and throughout the day, thus the chance of emergency situation reduces considerably. Also the machine has a user-friendly interface through which it can send data reports for each dialysis to the patient's smartphone and the consulting doctor. This new-age technology will make it very easy for the doctor and the patient both to assess the situation on a minute basis and take steps accordingly.

Implantable artificial kidney (IAK) is technologically more advanced and involves ultra-modern biotechnology. IAK is 
basically a biologically programmed artificial mechanism that mimics the work pattern of an original kidney in a cellular level. IAK once implanted in the patient's body will require minimal maintenance and provide non-stop support to the patient. While the technology is still in the developmental phase and awaiting trials, the researchers and doctors are hopeful as this technology can change the fate of kidney treatment forever, providing a long-term treatment free from side-effects to save millions of lives.

Peritoneal dialysis. This is an effective renal replacement strategy for patients suffering from end-stage renal disease. PD offers patient survival comparable to or better than in-center hemodialysis while preserving residual kidney function, empowering patient autonomy, and reducing the financial burden. The majority of patients suffering from kidney failure are eligible for PD. In patients with cardiorenal syndrome and uncontrolled fluid status, PD is of particular benefit, minimizing hospitalization costs and duration.

A PD system that recycles dialysate would potentially be more eco-friendly, and fewer connections and disconnections could significantly reduce the risk of peritonitis, the commonest cause of PD technique failure. The peritoneal dialysis catheter sets up a foreign body reaction in the cavity and often becomes infected; new polymers are needed to minimize the resulting inflammation. New osmotic agents are needed to substitute for glucose that sets up a diabetic state in the cavity that leads to peritoneal sclerosis. The new wearable technology that provides continuous dialysis for patients on the move presents significant challenges to the design engineer.

Road Ahead

The market for wearable and portable dialysis devices would be limited to the more active and self-reliant patient, whereas an implantable device could potentially be made available to all dialysis patients. However, any implantable device not only has to have minimal risks for insertion but also has to operate effectively and not fail prematurely.

Currently there are no implantable devices undergoing trials, but research is underway to overcome the main hurdles faced by an implantable dialysis device. Implanting a device between the iliac arteries and veins has the advantage of not requiring a blood pump.

Although arterial grafts have been a major success in treating patients with arterial vascular disease, arterio-venous grafts have not been successful for HD access with an increased risk of graft thrombosis. The current generation of wearable dialysis devices has to overcome two important basic design problems - first to operate using powerful small light-weight battery-powered pumps and second to avoid reliance on fresh dialysate by developing sorbent technology to re-use spent dialysate. The renewed interest in wearable devices has resulted in innovations in sorbent technology that will hopefully lead to lighter weight devices that underpin their potential success. These new generation technologies look forward to the development of a newer generation of dialysis devices which could potentially improve quality of life of the patient with chronic kidney disease.


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