Robotics: the Future of Minimally Invasive Heart Surgery

Introduction | Computer Motion

Recent Advances

Predicted Advances

Robotic References

 

Just imagine coronary bypass as an outpatient procedure. No more messy sternotomies, no more heart lung machine, rather a computerized, robotics team working through 4-6cm holes on a beating heart. On September 24th, 1999 these unfathomable advances in heart surgery became a reality, as Surgeons at London Health Sciences Centre's university campus performed the first robotic assisted closed chest bypass on a beating heart.
 

Robotic assisted bypass is a rapidly growing phenomenon in minimally invasive heart surgery, as coronary surgeries can now be performed by robot arms with the aid of a tiny video camera. In this operation, three pencil-sized ports are standard. Through one port a tiny high-powered, voice-operated camera or endoscope is inserted and held by a robotic arm. Two robotic arms that control the surgical equipment are inserted in the other ports. The physician's role is to maneuver the camera through voice-operated controls and to manipulate the surgical equipment using a hand held joystick. Thus the only surgical cut that a physician directly performs is the initial puncture of the chest. 

Besides the obvious advantages of keyhole punctures and the absence of a heart-lung machine, robotic assisted bypass eliminates errors involving human hand tremor and enables precise micro-movements beyond the scope of human vision. Robotics has enabled surgeons to perform cuts and operations beyond the scale of human ability.

By eliminating the often-intangible inaccuracies of human error, robotics has ushered in a technological, rather than physician dominated era of heart surgery. According to the Lancet (04/01/99) physicians were once wary of the time and training that robotics required, but recently, thanks to researchers at The John Hopkins Institute, a center has been established to train surgeons in the new technology. As more and more physicians began to adopt these methods, the need for companies to meet their demands becomes increasingly essential. Recently, Computer Motion has stepped up to meet the demands of this changing era in heart surgery.
 
View a robotic-assisted surgery video performed by Dr. Ralph Damiano 

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 Computer Motion     (www.computermotion.com)

Computer Motion of Santa Barbara California has become the leading producer of medical robotics. Products like  Aesop,  Hermes, and Zeus are the next generation of surgical equipment and are used together to create a highly networked and efficient OR. These products have increased Computer Motion's revenue by 71% in 1999. Revenues for Computer Motion reached $18.1 million in 1999 up from $10.6 million in 1998. With a patent that includes the techniques for robotic arm suturing Computer Motion seems to represent the future of robotic assisted technologies, yet emerging companies like Intuitive Surgical, Incorporated have devised their own technology to compete in the robot market. In actuality Computer Motion has a limited history and has not yet made a profit. Their products have not received significant market acceptance, nor has the FDA cleared all of their technologies. Given the rather lengthy and expensive procedure of FDA approval, computer motion often relies on third party payers to reimburse hospitals for the use of their product. Philanthropy is an unreliable source of funding given the existing alternatives to robotic technology, and the rapidly changing pace of the technological world. The fact remains that its products are untested and expensive. Ultimately, the success of computer motion will rely on receiving patents for their products and waiting for FDA approval. If the world market ultimately accepts the use of their technology in minimally invasive procedures, then computer motion will surely be the leader in medical robotics.

click on website for state of the company
(http://biz.yahoo.com/e/991112/rbot.html ; http://biz.yahoo.com/n/r/rbot.html )
 

 Aesop     (http://www.computermotion.com/aesop.html)

When the FDA cleared Aesop in 1994 it became the first robot to assist surgeons in the operating room. With its use in over 70,000 procedures (heart and all others) performed since that point, Aesop has become a reliable and often indispensable aid in the operating room. 

 Aesop's function is quite simple merely to maneuver a tiny video camera inside the patient according to voice controls provided by the surgeon. By doing so, Aesop has eliminated the need for a member of the surgical team to hold the endoscope in order for a surgeon to view his operative field in a closed chest procedure. This advance marked a major development in closed chest or port-access bypass techniques, as surgeons could now directly and precisely control their operative field of view. Today about 1/3 of all minimally invasive procedures use Aesop to control an endoscope. Considering each Aesop machine can handle 240 cases a year, only 17,000 machines are needed to handle all minimally invasive procedures a relatively small number considering the benefits of this technology. Aesop costs around $65,000 and has performed well in all the clinical trials that it has undergone. Ultimately, Aesop has the potential to dominate the minimally invasive market.

 (43)

 

Hermes     (http://www.computermotion.com/hermes.html)
  

 Unlike Aesop and Zeus, Hermes does not use robot arms to make the Operating Room more efficient. Rather Hermes is platform designed to network the OR, integrating surgical devices, which can be, controlled by simple voice commands. Many pieces of surgical equipment are outside the range of sterility for the surgeon and must be manipulated by a surgical staff while Hermes enables all needed equipment to be directly under the surgeon's control. Hermes can integrate tables, lights, video cameras and surgical equipment decreasing the time and cost of surgery. Ultimately Hermes decreases the need for a large surgical staff and facilitates the establishment of a networked, highly organized OR. Ultimately Computer Motion is working to bring Hermes into 84,000 operating rooms worldwide 
 

 Zeus     (http://www.computermotion.com/zeus.html)

 Meet Zeus the youngest and most technically advanced robotic aid. Zeus contains robotic arms that mimic conventional surgical equipment and a viewing monitor that gives the surgeon a view of his operative field. More importantly, Zeus enables a surgeon to operate on a patient using joystick like handles which translate the surgeon's hand movements into precise micro-movements inside the patient. For example a 1-cm movement by a surgeon's hand is translated into a .1 cm movement of the surgical tip held by a robotic arm. Zeus also has the unique capability of reducing human hand tremor and greatly increasing the dexterity of the surgeon. "ZEUS allows surgeons to go beyond the limits of MIS enabling a new class of delicate procedures currently impossible to perform." Now all computer motion needs is FDA approval to begin clinical trials in the US on their wonder-robot. The ZEUS System is currently under an FDA-approved Phase I Investigational Device Exemption (IDE) study and is CE Marked for commercial sale in the European Community. Computer Motion has partnered with Medtronic to co-market ZEUS," which runs at around 1 million dollars per robot.
 

Minimally invasive procedures 
for these surgeries in yellow; ZEUS  
has potential to assist in over 15,000 
operations

Zeus Robotics System

 

Benefits of Zeus

- no sternectomy necessary, pencil-sized incisions reduce patient pain and result in shorter hospital stays
- operation on beating-heart removes complications of a heart-lung machine
- Zeus eliminates human hand tremor improving surgeon precision and dexterity
- tiny high, powered endoscope improves visualization in 2-D or 3-D field
- robotic arms don't fatigue
 
 Drawbacks of Zeus

- virtually untested technology
- machine costs around 1 million dollars
- FDA approval is pending
- physicians require additional training (http://www.computermotion.com/course.html)
 
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da Vinci Surgical Station

If Zeus is going to grab a hold of the robot surgery market it needs to compete with a similar robot named da Vinci, which is produced by Intuitive Surgical, Incorporated. da Vinci has already had some success in the worldwide market participating in around 300 cardiac procedures worldwide since 1998. da Vinci has performed CABG as well as heart valve repair and replacement and atrial-septal defect repair procedures. Like Zeus, da Vinci costs around 1 million dollars. 

Click on website (http://www.osu.edu/units/research/archive/surgpics.htm) to view a North American cardiac procedure using da Vinci at the OSU Medical Center.
 
(47,48,49,50,51)
 
 

Recent advances in Robotic Technology

September 24th 1999- the first robotics assisted closed chest bypass on a beating heart was performed at the London Health Sciences Centre on 60-year-old dairy farmer John Penner. Cardiac surgeon Dr. Douglas Boyd controlled the operation at the Ontario clinic that had bought its Computer Motion technology with the help of a 2 million-dollar gift from London philanthropists Richard and Beryl Ivey. Penner was discharged after four days instead of a week, claiming that he never felt better.
 
 November 22, 1999 - the first closed-chest beating heart cardiac hybrid revascularization procedure is performed at the London Health Sciences Centre (London, Ontario). In the first step of a two step procedure Dr. Douglas Boyd used Zeus to perform an endoscopic, single-vessel heart bypass surgery on a 55 year-old male patient's left anterior descending artery. In the next step of the procedure William Kostuk, MD, Professor of Cardiology of the University of Western Ontario, completed an angioplasty revascularization on the patient's second occluded coronary vessel. This multi-step procedure marked one of the first integrative approaches to treating coronary disease.
 
 December 9th 1999- Dr. Ralph Damiano, Jr., chief of cardiothoracic surgery at the Milton S. Hershey Medical Center at Penn State College of Medicine in Hershey performed the first robotic assisted beating heart bypass in the United States. Damiano used the Zeus Robotical Surgical System to perform the one of three bypass grafts on a 70 year old woman as part of 10 experimental procedures that will take place at the center. Eventually the center hopes to perform an entire bypass operation with Zeus.

January 26th 2000 - Multiple cardiac centers in Europe announced the successful completion of several totally Endoscopic Coronary Artery Bypass (TECAB) procedures using da Vinci surgical systems.

March 13, 2000- Francois Laborde, MD, Ph.D., Chief of Cardiac Surgery at L'Institut Mutualiste Montsouris Chiosy (Paris, France) used Computer Motion's ZEUS™ Robotic Surgical System to perform seven fully endoscopic closures of the patent ductus arteriosis (PDA). This marked the first time pediatric cardiac procedures had been performed using robotic assistance. All seven of the young patients experienced reduced scarring, recovery time and pain thanks to the procedure.
 
click on websites for press releases
(http://www.computermotion.com/press00.html ; http://www.computermotion.com/press99.html )

(52,53)

 

Predicted advances in Robotic Technology
 
 When assessing the future of robotic assisted minimally invasive heart surgery it is important to reflect on the relative success rates in clinical trials designed to test the efficacy of these techniques. Although Computer Motion has received FDA approval to pursue clinical trails for Hermes and AESOP, Zeus has yet to be granted regulatory clearance in the United States. Thus, trials on Zeus must be limited to overseas clients. The FDA has some concerns about robot assisted surgeries.

"While medical robots may make some surgical procedures easier or help the surgeon perform an operation more precisely, the Food and Drug Administration, which regulates these new devices, has several concerns. One concern is software. Today's robotics devices typically have a computer software component that controls the moving, mechanical parts of the device as it acts on something in its environment. FDA reviewers evaluate the software components of such devices because the software is "command central" for the device's operation. When evaluating the devices, FDA looks to see if the company is following good software engineering practices in writing and designing the software. These practices often include establishing device requirements, writing good specifications, evaluating the software and device, analyzing the device's potential hazards, and implementing controls that specifically address those hazards. Other concerns include the safety and effectiveness of the hardware component of the device." [58]

In the case of AESOP, Computer Motion has recently concluded three separate minimally invasive valve surgery trials using this technology. All 300 surgeries were safely performed and resulted in a 20% decrease in operative time, as well as nearly a 25% decrease in perfusion time and cardiac arrest when compared to surgeries performed with manually manipulated cameras. The major question that remains is when Zeus will receive clinical approval and whether it will perform well in clinical trials. Recent isolated surgeries using this machine have been successful yet a full-on trial cannot yet be attempted. If Computer Motion receives the financial backing and approval that it needs to survive, the future of robotic-assisted minimally invasive heart surgery looks bright. Moreover, if the medical community accepts robotic surgery it has the potential to dominate the OR. Although the surgery is now performed only as a single bypass, Dr. Douglas Boyd predicts that it will be used for multiple bypass, heart valve repairs and pediatric surgeries. For now overseas hospitals and medical communities seem to be embracing the possibilities of a mechanical OR. The London Center in Ontario claims that they will increase the number of robotic assisted bypass surgeries from about five per cent to 30 percent of the 1700 of these operations that they perform in a year.

(54,55,56,57,58)

                                                                                                                            5/03/2000


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