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Davinci robot and hernia surgery- cleared procedure?
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I’d mesh was implanted laparoscopically and has to be removed the same way the robotic da Vinci has some major advantages in experienced hands for mesh removal
1) 3D camera giving the surgeon superior visibility of all the structures which is extremely important when removing mesh
2)the robotic arms can rotate 360 degrees giving the surgeon the ability to perform certain tasks the human wrists just can’t do
3) prevents fatigue on the hands in long surgeries which mesh removal can be
I had my mesh removed with the robotic assisted lapro-by dr. Igor belhansky in MD as he specializes in this type of instrument and surgery.
most lapro surgeons are now turning to the da Vince for mesh removal (of it was implanted laparoscopically ) -
quote Davinciproblems:I am referencing handling and manipulating mesh
Ah yes, I see your point now. That is true… I think. It has not been cleared for implantation or explanation of a surgical mesh specifically. It is kind of assumed that it is OK… I think. But yes, it is not worded in the text. Perhaps [USER=”935″]drtowfigh[/USER] can tell you something about that?
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the issue :
“Within a short period (<10 seconds), sufficient heat from capacitance may
build up from the corona discharge at the interface of the active
electrode and nearby conductor to burn the insulation of the electrode,
resulting in direct contact(arcing, sparking, shorting) of the electrode
to the adjacent conductor. Each spark reaches temperatures of 700C
to1000C,
and sparks are delivered at 30,000 per second in the coagulation mode.
Undersparking conditions, therma linjuryto tissue is instantaneous,
inevitable, and severe. This is es-pecially true in hollow organs, such
as bowel, where a single spark can destroy the mucosa, which may lead to
delayed perforation 3 to 15 days post operatively.Our experimental data
show that 100% of the reusable ro- botic laparoscopic instruments used
with the da Vinci plat-form leak electricenergy at the end of their life
cycle.Previous studies have reported prevalence of insulation defects
in laparoscopic instruments at a lower rate of 19% to 39%”Stray Electrical Currents in Laparoscopic Instruments Used in da Vinci ®
Robot-Assisted Surgery: An In Vitro-http://www.academia.e…Mesh (polypropylene) has a melting point : [h=3]Thermal properties[/h]
The melting point of polypropylene occurs in a range, so the melting point is determined by finding the highest temperature of a differential scanning calorimetry chart. Perfectly isotactic PP has a melting point of 171 °C (340 °F). Commercial isotactic PP has a melting point that ranges from 160 to 166 °C (320 to 331 °F), depending on atactic material and crystallinity. Syndiotactic PP with a crystallinity of 30% has a melting point of 130 °C (266 °F).[8] Below 0 °C, PP becomes brittle.[9]The thermal expansion of polypropylene is very large
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I am referencing handling and manipulating mesh
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quote Davinciproblems:From my research, the instruments are cleared for handling soft tissue only. Do you have the clearances for handling other materials?
A hernia repair is a soft tissue repair. I’m not sure what you’re getting at?
From dvuro (da Vinci urology) website:
http://www.dvuro.com/technology.php“The PK Dissecting Forceps may only be used on soft tissue. Do not use it on cartilage, bone or hard objects. Doing so may damage the instrument or make it impossible to remove from the cannula.”
“The Harmonic ACE Curved Shears Instrument is designed to be used in conjunction with both the da Vinci System (S and Si models) and a compatible Ethicon Endo-Surgery Generator and Hand Piece. It is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. This instrument may only be used on soft tissue. Do not use it on cartilage, bone or hard objects. Doing so may damage the instrument or make it impossible to remove from the cannula.”
Again, this text passage describes how or when not to use the different instruments (of a certain da Vinci model) in urologic procedures.
“Each quarter this page will highlight the use of da Vinci advanced technology in different urologic procedures. The highlight will include an opinion from a surgeon currently using the system and technology. If you are looking for additional information on the use of the technology, please visit the da Vinci Online Community.”
What kind of surgery do you need? And what robot system and model do you plan on using?
What kind of da Vinci problem do you have Mr./Mrs. da Vinci problems? Are you a surgeon or a patient?
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“only be used on soft tissue. Do not use it on cartilage, bone or hard objects. Doing so may damage the instrument or make it impossible to remove from the cannula.”
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From my research, the instruments are cleared for handling soft tissue only. Do you have the clearances for handling other materials?
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On the same topic, “Intuitive Surgical wins FDA nod for inguinal hernia repairs with da Vinci Xi”
https://www.massdevice.com/intuitive…s-da-vinci-xi/
And here is the FDA document, dated 2017:
https://www.accessdata.fda.gov/cdrh_…17/K170713.pdf
Similarly, here is the indication for use:
“The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model lS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors,scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.”
Note how it says “urologic surgical procedures, general laparoscopic surgical procedures”. Well guess what? Hernia surgery falls under general surgical procedures. Also note that this document relates to model lS4000. So it may or may not be applicable to model SP999 indicated in the previous document. You be the judge of that.
Generally speaking though, I would not go for a laparoscopic operation of an inguinal hernia, be it robot assisted or traditional video laparoscopy. I rather put my trust in the hands of an experienced, traditional surgeon with a lot of experience, than hyped up high tech gadgets like surgical robots, plastic meshes and all that sort of thing. That’s just how I see things.
I see that there is a lot more interest in the business side of things than the medical side of things, you know in helping people get better. Which by the way should be the number one priority for any surgeon, physician or doctor. If I have a hernia, I need medical help, I need someone to help me treat it, someone who puts my well being at the front. I am not interested in filling someone’s pocket with money just for the sake of it. If you work in this field, or any kind of profession really, money should not be your first priority, you need to have passion for the job first and foremost and have people’s well being as your first priority. But in the society that we live in, that we have built, everyone is chasing the dollars, the yens, and the euros, etc. It’s a pretty cold, insensitive, unfair and unjust world that we live in. Everyone has only their own best interest in mind.
But to answer your question directly, yes, the da Vinci robotic system has been approved for general surgery procedures, including hernia surgeries. But apparently only certain models have been approved for that, as indicated in the document above. So it’s good that you do your own homework and make sure the robotic system that will be used in your operation has been approved for that type of procedure. You may also find that the same system has been approved by government or federal agencies in one part of the world but not in other parts of the world, just like with medicine. So while a system may not have been approved for one type of operation by the US regulatory agencies, it doesn’t necessarily mean it is not safe to use in that particular way. It may, or may not, have been approved in a different country, on a different continent, for the same type of operation. Regulatory approval may be under way in the US.
Don’t get too hanged up on the da Vinci. It is the best recognized and most widespread system, with about 4400 systems rolled out worldwide, and about 43000 trained surgeons. But there are many more competitors up and coming now. Some of the most notable are TransEnterix and CMR Surgical. Some of them may or may not be approved for hernia surgery. Some of them may be more or less beneficial for hernia surgery. Who knows?
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From the same document:
“Intuitive Surgical Endo Wrist® SpTM Instruments are controlled by the da Vinci® SpTMSurgical System, Model SP999, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery, and accessories for endoscopic manipulation of tissue, including grasping,cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single incision laparoscopic approach. The system is indicated for urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.”
It is indicated for urologic use only?
“The system is indicated for urologic surgical procedures that are appropriate for a single port approach.”
Should we all be concerned if the system is used for hernia surgery? Is that what you’re saying?
According to the manufacturer website, it can be used, and it is used for hernia surgeries as well.
http://www.davincisurgery.com/da-vinci-general-surgery/da-vinci-hernia-surgery.php
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https://www.accessdata.fda.gov/cdrh_docs/pdf13/K131962.pdf
i would review any/all davinci instruments that have been used in or are going to be used in any type of mesh surgery. It appears most of the endowrist instruments have only been cleared for use with soft tissue.
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