Project 2
Design a robotic surgery procedure to remove a healthy kidney from the donor using an AI-gu
The idea of robotic kidney transplantation surgery is that a healthy kidney is removed from a donor using a surgical robot.
Robotic Kidney Transplantation surgery from a living donor
- The field of robot-assisted kidney transplantation is recently been intrigued to reduce the incidence of open kidney transplantation
- It has overcome many limitations of the classical laparoscopy
- Complex technically demanding procedures such as
- Ureteral Anastomosis
- Vascular
- First, in 2010, this Robot-assisted kidney transplantation procedure has been performed with highly experienced robots and kidney transplantation centers around the world
- European Association of Urology and Robotic Urology Section(ERUS) Society in Europe created the Robot-assisted Kidney Transplantation working group in 2016
- The robot-assisted kidney transplantation surgery is
- Safe
- Reproducible in selected case
- Can yield excellent graft function with a very low complication rate
- The transplantation of robot-assisted kidneys can be divided into 3 types
- Robot-assisted kidney transplantation (RAKT)
- From living donor
- Robot-assisted kidney transplantation (RAKT)
- From deceased donor
- Robot-assisted kidney autotransplantation
Fig: Robot-assisted kidney transplantation
In this project, we will be discussing in detail designing the Robot-Assisted Kidney Transplantation from a living donor.
Robot-Assisted Kidney Transplantation: Living donor(RAKT)
History and Background:
- A researcher named Ratner wrote in his paper on " Introduction of Laparoscopy" in 1995 about the open donor nephrectomies which were carried out for 50 years until laparoscopy was introduced
- In 2001, the first robot-assisted laparoscopic donor nephrectomy was performed using the da Vinci surgical system which was reported by the Group of the University of Illinois in Chicago
Present scenario:
- Nowadays in USA 40% and in Europe, 20% of kidney transplantation around the world is performed with living donors
- Most of the kidney donors are currently family members or those who are close with the patient
The preferred case for living donor:
- For two equally functioning kidneys, the left kidney is preferable because the left renal vein is longer in comparison to the right renal vein.
- If both kidney function is different then less kidney function is used to limit the risk of the donor.
Specific requirements to employ robots in Kidney Transplantations:
The robot basically replicates the surgeon's hand movements and it is useful in operative care when there is a need for deep and narrow fine dissection with micro suturing.
The specific requirements to employ the RAKT are given below:
- The RAKT has low postoperative and intraoperative complications, especially for end-stage renal disease patients undergoing Kidney Transplantation
- Superlative vision could give a better result for vascular and ureteral Anastomosis
- This surgery is minimally and hence has various advantages such as
- Reduce pain
- Low amount of blood loss( Range from 10-1,500 ml)
- Fewer hospital stays (Range from 1-8 days)
- Less recovery time
- Surgical scars are not too deep and can be easily recovered
- Less operative time such as 103 minutes
The surgical robot used in the procedure
The da Vinci Surgical Robot
Manufacturer- Intuitive Surgical Inc. Sunnyvale, California
It is a robot-assist technology to Perform complicated surgical procedures through a small incision
- Tools include
- Endoscopic camera with magnifications
- Lighting and temperature control arm
Uses of Da Vinci surgical system for a complex and minimally invasive procedures such as
- Gynecology
- Urology
- General surgery
- Head and neck surgery
- Cardiothoracic surgery
Functions
- To stabilize motions and reduce physiological tremors
- Precision tasks assist by scaling motions
- Augmented surgeons senses
- Provide navigation assistance within the anatomy
- Anticipate and warns the user of critical events
- Automatically do surgical tasks or subtasks
Features
- The surgeon is in control
- Three primary components
- Viewing and controlling console
- Vision cart
- To hold the endoscopes and provides visual feedback
- Surgical robot manipulator
- Arm unit includes
- Three or four arms depending upon the model
- Sensors
- Optical encoders
- Hall sensors
- Magnetic encoders
- Infrared sensors
(Fig: 1)Master control console 2)The control unit 3)Second master control 4) This system allows the dual surgeon 4 hand procedures
Specific features of the robot useful for robot-assisted kidney transplantation
- 3D Vision- 3D endoscope used in the da Vinci system
- Accelerate the learning curve for the non-laparoscopic surgeons
- 6 degrees of freedom
- Fully articulating instruments
- Magnified stereoscopic vision
Source: https://www.researchgate.net/publication/313222527_Medical_Robots_Davinci_system
Block diagram of the surgical robot- The da Vinci surgical system
Fig1: Simplified block diagram of the system architecture including the master surgical console and slave surgical robot which is connected through a communication layer with three options
Fig2: The block diagram includes the main parts of the da Vinci surgical system
- The control system- Master control
- The slave console - The passive and actuated arms and endo wrist
- The control unit and the motion mapping between the master and slave
Flowchart of the surgical process :
Fig1: Flowchart showing decision-making strategy for robot-assisted kidney transplantation for living donor
Fig2:Flowchart shows the process of development and operation of the robot-assisted surgery system
Fig3: Surgical procedure flowchart
- At first, a robot-assisted donor nephrectomy is performed
- A ureteral double j stent is placed in the graft(Kidney graft)
- Transplantation phase
- Trocar placement and patient monitoring
- Introduction of the kidney and ice through gel point device which is used for incision
- The graft that is introduced into the abdominal cavity
- Gel point cup is inserted and the abdomen is closed
- Venous anastomosis and arterial anastomosis performed
- Lich Gregoir technique of ureteroneocystostomy is performed
- Clipping and ligation of the suture
- All the trocars were removed
At first, a robot-assisted donor nephrectomy is performed.
- (A) Ureteral double j stent is placed in the graft(Kidney graft)
- (b) The graft is then wrapped in a gauze jacket filled with 300 cc ice slush
Transplantation phase :
Trocar placement and patient monitoring.
Fig:
- Introduction of the kidney and ice through gel point device which is used for incision.
- The graft that is introduced into the abdominal cavity.
- A Gel point cup is inserted and the abdomen is closed.
Venous anastomosis performed
Arterial anastomosis performed
Lich Gregoir technique - ''The dissection of the detrusor from the underlying mucosa is carried around the ureter circumferentially while maintaining the continuity between the ureter and the bladder. ''of ureteroneocystostomy is performed
- Clipping and ligation of the suture.
- All the trocars were removed.
Fig: Results of RAKT after 3 months
Tasks performed by the AI used in the robotic kidney transplantation
Patient and trocar positioning
- First, the patient is positioned in dorsal decubitus
- 20 to 30° Trendelenburg position recommended
- Required robotic instruments
- Monopolar scissors
- Potts scissors
- Bipolar forceps
- Prograsp forceps
- Large needle driver
- Black diamond micro forceps
- Bulldog clamps
- 12 mm camera list is inserted in the supra umbilical area
- Veres's needle puncture, Hasson technique, and optical trocar access are used for assessing the abdomen
Docking maneuver
- The robot is docked by placing three extra robotic 8 mm ports under the vision.
- Gel point device replace the camera trocar through 6 to 8 cm incision is performed.
- The assistant of a 12 mm trocar for suction irrigation, removal, and introduction of the suture materials and clip application was then placed.
- Standard instruments.
- Hot shears.
- Fenestrated bipolar forceps.
- Cadiere forceps.
- Large Suturecut needle driver(Endowrist).
Method 2
Right donor nephrectomy
- It is done in a similar manner for the left donor nephrectomy where the ascending colon was mobilized
- After that, it is displaced medically which allows access to the Gerota's fascia and perirenal fat
- In comparison to the left side renal vascular stalk, the right renal vein is shorter
- Clipping and ligation are used to close the inferior vena cava
- The kidney was then extracted in an endo bag after flushing it with 200 ml of heparinized ice-cold solution
- Method 3
Ureteroneocystostomy
- According to the Lich-Gregoire technique, ureteroneocystostomy is performed
- A suture is running between the ureter and bladder mucosa to construct a detrusor tunnel which can be used as an anti-reflux mechanism
- A ureteral stent is then interred to protect the Anastomosis which can be removed after 3 to 4 weeks
Trocars are removed under direct vision while evacuating the pneumoperitoneum
Sometimes depending on the surgeon's decision 12 Chr. Robinson drain was inserted into the wound bed
The operative steps to be taken for successful surgery
A methodological review of various techniques for robot-assisted kidney transplantation.
For this, I have selected 3 researcher's techniques for further review in their respective techniques
- At first researcher, Giulianotti's paper from Chicago is selected in which the first full RAKT report was written
- The second researcher Boggi is the first one from Europe to perform RAKT. His research paper is selected for further evaluation
- An Indian researcher Menon from Detroit collaborated with Ahlawat in Gurgaon and Modi in Ahmedabad where the two kidney transplant programs in India were established. The research paper written by him on his work is discussed in the reviewing techniques
The operative steps to be taken for successful surgery
Preoperative steps
- The patient should follow some basic rules before the operation.
- Stop drinking or smoking.
- Lose any excess weight.
- Regular exercise.
- Dialysis before the transplantation.
- Vaccinations advised.
- To obtain necessary lab tests.
- CT or MRI angiography performed.
- Preoperative steps for the robot system.
- To ensure whether all the function of the robotic system is performing well or not.
Perioperative steps
- The patient is lying on the bed in the Trendelenburg position.
- Anesthesia and required medication are given before the surgery to operate the procedure.
- A small incision of about 7 cm is made with the assisted robotic system and another 4 or 5 small incisions are made to insert the instruments into the abdomen.
- The high magnified 3D camera was inserted into the abdomen through one of the keyholes.
- The diseased kidney is removed and the living donor kidney is inserted into the abdomen.
- The robotic arms do the clipping and ligation of the blood vessels and the ureter.
- The surgeon uses the console to perform this minimally invasive surgery.
Postoperative steps
- After the robotic surgery, the patient should take a semi-reclining position
- The healthcare provider should give analgesics for any respiratory depression if occurs
- If the ureteral stent is inserted for urine drainage then it can be removed after 3 to 4 weeks
- Some complications might occur after the robot-assisted surgery such as
- Damage to surrounding structures
- Twisting of the kidney after the transplant
- Development of a hernia from small incisions by the instruments known as port site hernia
- Scarring affects the bowel
- Trapping of CO2 used during the surgery of the abdomen
- Nerve compression
- Healthcare has to take care of all these situations by observing the warning signs to give immediate assistance for the complications
- If no complicated situation occurs, the patient is given release from the hospital within 5 to 7 days depending upon the recovery of the patient
- Exercise and rehabilitation care of the patient
Post-operative cleaning for the robotic system
- After any procedure is complete, the device was cleaned and sterilized before reusing it on another patient and disposables must be discarded to avoid communicable diseases.
Ethical concerns and regulations of a kidney transplantation procedure
Ethical concerns of healthcare AI kidney transplantation procedures
- Data collection
- Automation
- Bias
Data collection
- Poses patient privacy concerns.
- The scarcity of real, accessible patient data hinders the training of effective AI algorithms.
- A manual and tedious process.
- Probe to human errors.
- Bad data equals to ineffective systems.
Automation
- Cab replace jobs, especially those menial jobs involving digital information, radiology, pathology.
- AI can assist healthcare workers in their jobs.
- Tackle cognitive overload.
- Reduce healthcare worker's burnout.
- Improve the quality of care, autonomy, and better communication.
Bias
- AI algorithms depend on data.
- Inherent socioeconomic biases in data can reflect in unfair AI algorithms.
- Accurate representation of minorities required
- White males are overly represented in medical datasets
- Collected data is not uniform in quality, which can result in biased results
Regulations
- Many institutions have an Institutional Review Board(IRB) that applies research ethics to the biomedical research conducted in the institute and its members
- In India, medical devices are regulated according to Medical Device Rules,2017, by the Ministry of Health and Family Welfare
- The device classification according to the medical rule is discussed below
List of international regulations
US Health Insurance Portability and Accountability Act(HIPAA)
- A federal law that is required to create national standard products to protect sensitive patient health information from being disclosed without the patient's consent or knowledge .
European General Data Protection Regulation(GDPR)
- The legal framework which sets guidelines for the collection and processing of personal information from individuals who live in the European Union.
ITU-HO Focus Group on Artificial Intelligence for Health (FG-A14H)
- It is in inter collaboration with WHO and created benchmarking framework for assessing the accuracy of AI in health
- The data protection
Medical device classification
Needs
- Medical device designers and manufacturers need to consider the guidelines and classification systems while developing products.
- This ensures efficient devices, quick review and approval, and low time to market.
- Also ensures customer retainment, profits, and brand building.
Medical devices are classified into
- Based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness
- To prevent misrepresentation of a medical device and its performance
- Each country and region has its own metric of classification
- Additionally, there are a few standards adopted globally, like FDA and WHO
Indian standards
- The National Medical Device Authority in India classified medical devices into 4 classes
- Class A(Low risk)
- Eg: Thermometers
- Class B(Low moderate risk)
- Eg: Hypodermic needles
- Class C (Moderate high risk)
- Eg: Lung ventilators
- Class D(High risk)
- Eg: Heart valves
FDA standards:
- FDA categorizes medical devices into 3 classes:
- Class I(low risk)
- Eg: Crutches
- Class II( Medium risk)
- Eg: Pregnancy Test Kits
- Class III (High risk)
- Eg: Pacemakers
EU standards
- According to MDR, devices are classified as:
- Class I
- Provided non-sterile or do not have a measuring function for example : Wheelchairs
- Class I
- Provided sterile and/or have a measuring function(low/medium risk)
- Class IIa(medium risk)
- Example Hearing Aids
- Class IIb(medium/high risk)
- Example: Infusion pumps
- Class III(high risk)
- Example: Prosthetic joints
IEC 60601 standards applied to the equipment :
- A set of technical specifications for the safety and performance of medical electrical equipment
- Maintained and published by International Electrotechnical Commission (IEC)
- As of 2011, it consists of
- General standard
- 10 collateral standards
- 80 particular standards
IEC 60601 general standard
- IEC 60601-I
- Medical Electrical Equipment -Part I: General requirements for basic safety and essential performance
- Compliance with IEC-60601-I is required for most markets
- IEC 60601-I The use of this standard does not assure the efficacy of the medical device
- Evidence of effectiveness is further required by regulating bodies in the form of Premarket Approvals
IEC 60601 collateral standards
- It defines the requirements of certain aspects of the safety and performance
- For example
- Electromagnetic compatibility (IEC 60601-1-2 )
- IEC 60601-1-3 Protection for diagnostics use of the X-rays
IEC 60601 particular standards
- Define the requirements of specific products like specific measurements which are built into the products
- For example
- MR scanners (IEC 60601-2-33)
- Electroencephalograms(IEC 60601-2-26)
Conclusion :
- The procedure of RAKT has been proven to be an advanced application for kidney transplantation
- The technique is nowadays standardized and surgical data shows that the RAKT data obtained are safe and feasible for kidney transplant surgery. All the rules and regulations are obeyed by the healthcare sector for the kidney transplantation surgery
- In the field of grafting from living donors, most experience is gained
- The RAKT technique is useful where complex renal, vascular or ureteral pathology couldn't be treated with the conventional open surgery method
- To summarise the detailed study I would like to conclude with the fact that to advance the field of these robotic techniques; proctoring and training are the key to safely introducing the advanced form of robotic techniques which can finally give the patient population a good advantage with minimally invasive approaches for the kidney transplant.
Source:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186662/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6193442/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4120216/
https://www.researchgate.net/publication/343113626_Robotic_in_the_field_of_kidney_Transplant_Surgery
https://www.cdc.gov/phlp/publications/topic/hipaa.html
https://www.emergobyul.com/sites/default/files/india-medical-devices-rules-2017.pdf
https://www.itu.int/en/ITU-T/focusgroups/ai4h/Pages/default.aspx
https://www.frontiersin.org/articles/10.3389/fsurg.2022.862322/full
https://josr-online.biomedcentral.com/articles/10.1186/s13018-020-02003-y
Image source
https://www.intechopen.com/chapters/70819
https://images.app.goo.gl/i8vZk6fUv7uxGVkb8
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