Hubertus Feussner - Department of Surgery, Klinikum rechts der Isar, Technical University Munich, Germany
Dirk Wilhelm - Department of Surgery, Klinikum rechts der Isar, Technical University Munich, Germany
Future developments in surgery are not only interesting for surgeons but also an issue for biomedical engineers and computer scientists in order to focus their own work and energy to areas which most probably become relevant. Surgery of the next decade may be described best by the keyword “surgery 4.0”.
The term and its meaning are as yet even unfamiliar to most surgeons and most probably even less known by engineers. We coined it in 2016 [Feußner 2016] to describe a vital development in surgery, which could conceivably become as disruptive in interventional medicine as the current trend toward economic and industrial digitalization. To make the parallels and contrasts more evident, a reflection on the Fourth Industrial Revolution is helpful. The global economy is assumed to move forward to the Fourth Industrial Revolution. Commonly, the mechanization of production using water and steam power is considered to have driven the First Industrial Revolution. The next “revolutionary” impact on industrial productivity came from mass production facilitated by the availability of electrical energy and improved workflow organization (assembly line, etc.). This was followed by the Third Industrial Revolution, which is characterized by the use of information technology (IT) and robots to automate production. Today, a systematic transformation of industrial production is under way, which can be grossly defined as the comprehensive computerization of manufacturing. The vision is some type of self-organizing or autonomous production: the factory with its production lines “understands” what has to be produced and autonomously carries out all necessary steps and adjustments. This strategy, originally propagated by the German Government as the Industry 4.0 initiative, is evidenced in the customization of products under the condition of highly flexibilized production. This highly automated technology is enabled by the introduction of methods of self-optimization, self-configuration, self-diagnosis, cognition and intelligent support of the few human beings who are still required to master this complex process. The main pillars are as follows: 1. Interoperability: The ability of machines, devices, sensors, and people to connect and communicate with each other via the Internet of Things (IoT) or the Internet of People (IoP).
2. Information transparency: The ability of information systems to create a virtual copy of a physical world by digital models with sensor data. The very dense net of information is available for all stakeholders. A huge amount of raw data have to be collected and interpreted in a higher context. 3. Technical assistance: Decision-making has to be facilitated by preparing all necessary information. Humans have to decide all necessary preconditions (information) that have already been provided. 4. Decentralized decisions: The ability of lowerlevel systems to make decisions on their own and to perform their tasks as autonomously as possible. Only in the case of exceptions and/or conflicting goals are tasks to be escalated to a higher level.
Autonomous decision-making by mechatronic support devices is the real disruptive element of Industry 4.0. Humans will need to be confident that machines are able to act and react reasonably, reliably, and as fast and as safely as a human worker. There are, however, some necessary preconditions for this vision to become reality.
1. The IoT must support direct communication or dialogue with the technical equipment. If one device alters its functionality, the whole technical environment is informed.
2. Data/information must be provided wherever it is needed in real-time and by a high-quality, reliable service (5G telecommunication).
End-stage heart failure (HF) is a major cause of mortality, morbidity and disability worldwide. Nowadays, a surgical and medical treatment of HF has a positive trend. But heart transplantation remains an optimal treatment of endstage HF. A shortage of donor organs has made this therapy available only for limited number of patients (1). This problem required a development of ventricular assist devices (VADs) for critically ilium patients. The first devices had large dimension, but by the aid of engineering and technology developers have the opportunity to reduce the dimensions of VADs (2, 3). This feature allows the use of VADs for treatment of patients with small body surface area. However, the miniaturization of pump components may lead to a high hemolysis level (4, 5). Thrombus formation remains a serious problem of axial and centrifugal ventricular assist devices (6-8).
A typical construction of axial VAD consists of a flow straightener, an inlet bearing, an impeller, an outlet bearing and a diffuser in series, and a stator (9, 10). Mechanical friction between the pump components in such devices is accompanied by heat generation, which depends on the pump design (11).
Conversion of electrical energy to thermal energy is inherent for any motor under normal operation mode (12). Heat dissipation occurs due to thermal emissions from pump housing and heat transmission of blood moving through a device. Herewith excessive heat generation can adversely affect the blood hemolysis level and the protein denaturation increasing the probability of thrombus formation (13). As a result the pump failure probability increases. This problem can be solved only by emergency surgery with full replacement of implanted VAD (14, 15). Currently, the influence of thrombosis on a rotary blood pump heat generation is not fully investigated. Therefore, in vitro tests were conducted in hydraulic closed loop using the rotary blood pump of the Sputnik VAD to determine the nature of heat generation for different conditions which are typical for implantable systems. Since 2012 the Sputnik VAD successfully used to replace of left ventricular function for patients with HF. This VAD is the axial and continuous flow pump.
- Arnold D, Wilson T. What doctor? Why AI and robotics will define new health. 2017. Available at: https://www.pwc.de/de/gesundheitswesen-und-pharma/as- sets/30597_healthcare_aI_ipad_interactive_v10.pdf. Ac- cessed 16 August 2017.
- Feußner H, Wilhelm D. Minimally invasive surgery and ro- botic surgery: surgery 4.0? Chirurg 2016;87:189–94.
- Maier-Hein L, Vedula S, Speidel S, Navab N, Kikinis R, Park A, Eisenmann M, Feussner H, Forestier G, Giannarou S, Hashizume M, Katic D, Kenngott H, Kranzfelder M, Malpani A, März K, Neumuth T, Padoy N, Pugh C, Schoch N, Stoyanov D, Taylor R, Wagner M, Hager GD, Jannin P. Surgical Data Science: Enabling next-generation surgery. arXiv:1701.06482, 2017
- Neumuth T. Surgical process modeling. Innov Surg Sci 2017;2:123–37.