All Holmium Laser Fibers are the Same, Right? Part 9 August 02 2016

Summing up...

IQ is on a mission to advance the application of lasers in surgery for procedures with clinically superior outcomes; laser URS is one such procedure and fibers for laser URS have been the subject of this historical design review. We do not have control over any holmium laser design, at this time, but we do study others’ designs in far more detail than any other aftermarket fiber company. We have also filed a provisional patent application for an improvement to holmium lasers that we’re working on.

In fact, we have, have had, (and will likely always have), more models of holmium lasers in our R&D optics lab than any other holmium fiber company. In addition to numerous Nd:YAGs, KTP and myriad diode lasers, to date we have had over a dozen different holmium lasers (and a FREDDY) in-house at one time or another, including models from Lumenis, Coherent, Dornier, New Star, LISA, WOM, and DEKA. When we need access to a laser that we can’t beg, borrow or steal, we have good relationships with mobilizers who allow us to test our devices on their lasers from time to time. Right now, we have a Trimedyne Omnipulse™ (80W), a Dornier Medilas™ (12W), an AMS StoneLight™ (30W), and a Coherent VersaPulse™ (80W). We’re looking for a used MediLas™ H20 (20W), a Litho™ (30W) and an Odyessey™ (30W) to expand our menagerie.

InnovaQuartz Holmium Laser Menagerie

Why do we have so many holmium lasers in our labs? It’s really quite simple. Where other companies will happily sell you their fiber for your laser, as likely as not they’ve never tested their fiber on your laser model. They may have “experience” indicating that it should work, meaning they’ve sold the fiber to others and didn’t get a complaint (or at least not too many complaints), but not getting a complaint is far from the same thing as testing for compatibility and high performance under stressful conditions.

We at IQ will be the first to admit that it is possible to design a fiber for a laser, sight unseen; that’s how IQ designed the first true 200 micron fiber for Dornier’s Medilas in 1997 and the only true 200 micron fiber for Quanta’s Litho in 2012. The Dornier 200 fiber design happened to be as good as it could get at the time (later testing on Dornier lasers confirmed this), but it was pure serendipity and the bar for performance was pretty low in those days. In contrast, the first iteration of the Quanta 200 fiber was disappointing at  < 85% efficient (at 30W), but when we were supplied with minimal laser optics train data -- the diameter of the rod and focus lens f-number --  it became possible to improve performance to better than 90% (efficiency). Even still, once we got the Litho laser in our lab we were able to improve to 98% efficiency with extreme reliability in bending (1.6 cm bend diameter @ full power, p<0.001). In most cases a designer has to have the laser that s/he is designing for, in the lab, to produce an optimized fiber design. More importantly, any manufacturer should functionally test fibers directly off the production line, and test the design on all intended laser platforms, at least from time to time. InnovaQuartz is the only manufacturer that tests 100% of our production, at relevant laser power and upon real, FDA cleared holmium laser generators.

Others may test their fibers, but they typically use a HeNe laser, or low powered diode laser, not a real surgical holmium laser (justifying the substitution on the basis of stability of the output – but instability is what we need to design for). It is not just the low power of such lasers that fail to challenge the fibers, but as we saw in Part 7, holmium wavelength(s) are uniquely damaging to optical fiber, particularly in tight bends. In many cases we don’t need all laser models to test production fibers. We currently test the Litho fibers, for example, on our VersaPulse for lack of a Litho (it was a loaner). This is not ideal but it works because the VersaPulse challenges fibers more than the Litho. We have so many lasers around and we’re usually looking for more because we only accept valid functional testing.

ProFlex LLF

Designing devices using the actual laser platform and 100% functional testing do cost more, but it is worth the cost. IQ’s design and test methods inspire confidence that simply is not available elsewhere because we provide fibers that are not only designed for the particular model laser being used, but use that very laser model for design optimization and then validate each and every fiber made by firing it on a the real, FDA cleared surgical laser without modification of any kind.

That we can test hundreds of fibers a day on our surgical lasers without repairing our laser optics is also a testament to ProFlex LLF’s robust design. In fact, IQ originated the “built in blast shield” with the first FDA cleared BlackHole™ holmium fiber termination back in 1996. ProFlex’ Pulsar™ HPC has the latest incarnation of that fundamental and original concept and as we did with the original; we execute it better than anyone else.

Each ProFlex LLF fiber is shipped in an individual fiber carton for added protection and ease of shelf stocking, with essential inventory control information clearly presented to provide error-free pre-operative fiber selection:  product, lot and expiry information are on the carton edge and front with a full label on the rear that is quality sealed to insure the contents remain unmolested until needed.

ProFlex LLF Front and Side Label

 

ProFlex LLF Back Label and Quality Seal

Our smaller core ProFlex™ LLF (laser lithotripsy fibers @ 150μm, 200μm, 273μm, and 365μm, excepting Trimedyne compatible fibers) are made to considerably longer length than other fibers @ 3.6 meters. The extra length reduces the risk of unintended stresses being applied to the fiber, e.g. stretching it between the laser generator port and patient, a fairly common failure mode based upon reports in the FDA MAUDE database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm is the Manufacturer and User Facility Device Experience database). Our new ProFlex™ SPY models are 4.25 meters long to facilitate use in upper GI surgery via duodenoscope. ProFlex SPY also features a tiny, laser-formed spherical lens on the Smooth Passage™ working tip to insure both easy fiber loading and for minimization of energy losses to Moses bubble formation (see Part 8).

ProFlex™ SPY and Tiny Spherical Lens Working Tip

Keep an eye on our website (www.innovaquartz.com) under the IQ University radio button, or follow me on LinkedIn, for new blog entries as we review the results of our competitor fiber testing on various laser generators -- IQ’s trademark Fiber IQ Test™ -- and as we develop new metrics for comparing fibers, or as we release more of our advanced technology to the marketplace; products for getting the most out of your surgical laser (and our own BPH lasers, in 2017). Better yet, become an IQ customer and receive preferential and exclusive access to all of our upcoming improvements, as well as our new products.

Upcoming product improvements and releases include:

Lotus™ IQ packaging for our fibers -- a coiled tube housing for simplified aseptic payout of ProFlex LLF,

ProGuard™ -- a line of sapphire tipped, burn back resistant small core fibers (patent pending),

ProFlex™ LDD75 – a 250+ KJ, side fire fiber for 120W holmium and 200W+ thulium & diode),

ProFlex™ LDDE – the only ergonomically designed, easy to aim, side fire fiber (200W Tm and diode) and

ProFlex™ LDDER – IQ’s revolutionary, resposable side fire fiber for Ho, Tm and diode lasers to 750 KJ.

If any part of this series on holmium fiber design piqued your interest and you want to learn more, or if you have a bone to pick with any of my models, theories, concepts or suppositions, feel free to contact me directly. My e-mail address is steveg@innovaquartz.com. Reach me by phone @ 623-434-1895 x101.

Final thoughts at the close of this series

A personal note --

As you may have surmised by now, I have a unique passion for urological laser surgery and the fiber devices that make it possible. I can’t easily explain why this is, but I’ll try to color it in a bit. Finding that I was good at designing surgical fiber devices made me feel good about myself and then, when it became apparent that I was really, really good at it, I was hooked.

I founded the original company in 1991 and found Brian Barr, an excellent partner in 2002. In the IQ reboot of 2013, Brian and I surrounded ourselves with other professionals who display similar passions for their work, all with knowledge of what makes up quality and an appreciation for meaningful work.

I’d put our research, design and engineering teams up against anyone in the world, as I would our quality assurance and regulatory groups. It is good to know your strengths, but in order to improve and advance you also have to recognize your weaknesses. We are not great at marketing, having never actually hired anyone with that responsibility, and it is very possible that we never will as it’s just not a priority. We do well in sales and customer support, but I know that we can do better.  We welcome your comments, good and bad, in relation to any aspect of our work. Feedback is fundamental to growth.

-- Stephen Griffin

“The bitterness of poor quality remains long after the sweetness of low price is forgotten” – Ben Franklin

Among the dozen or so competitive fiber designs that we have evaluated in the past two years are some that appear to be quite good, but even these have consistency problems. For example, 39 of 40 will pass all of our tests but one fails miserably. The fibers may work perfectly on Lumenis  and/or Quanta lasers but regularly fail on Dornier and/or AMS/New Star or vice versa. I have tried to describe the root causes of these kinds of failures in this blog series, by discussing the pros and cons of various design strategies.

While this series has discussed some noteworthy fiber designs in some detail, I’ve avoided describing each and every manufactures’ design for a variety of reasons, e.g. a manufacturer may have more than one design on the market at one time, or the true manufacturer may be undisclosed. But the overarching reason for avoiding discussion of individual fiber designs is that this is the single most litigious business I have ever been involved in; a fact that I was warned of when first contemplating production of my first fiber. (I erroneously assumed the litigation in question was product liability, given the nature of the products, and that didn’t scare me a bit because I am extremely confident of my designs. The friendly warning turned out to be in reference to companies suing one other, with some corporate attorneys on hair triggers.) My goal is to improve laser URS, but I also need to stay in business.

While there is risk in exposing the flaws of competitive fiber designs, the fiber design is far from the sole determinant of quality. Holmium lasers are more diverse than other lasers for a variety of reasons, including, but not limited to, the simple fact that there are multiple crystals that can serve as the gain medium, e.g. Ho:YAG, CTH:YAG, Ho:YLF. Wavelengths range from about 2.06μm to 2.16μm and each has different advantages and disadvantages, e.g. susceptibilities to thermal lensing, maximum pulse repetition rate, and maximum instantaneous power. There is no “one ‘size’ fits all” fiber with anything approaching high performance on any console. In fact, considerable expertise is necessary for compromising performance just enough on one laser model to permit reasonable function upon another and, in doing so, production variations become the bane of one’s existence. It just is not possible to make a (small core) fiber that works on every holmium laser from Smart™ 2100 to VersaPulse™ PowerSuite™; at least not today.

 

“There is no such thing as a free lunch” – 2nd Law of Thermodynamics

InnovaQuartz was the first holmium fiber company to recognize that holmium laser properties were diverging as more models were cleared for surgical use. Even though our BlackHole™ was a fiber design more tolerant of laser differences than any other, IQ began producing separate fiber designs for different ‘families’ of lasers almost fifteen years ago. Other companies have opted to compromise their fiber design for ‘universality’  or at least broad compatibility, with the notable exception of Boston Scientific’s AccuMax™ and Flexiva™ (the former being designed for Dornier and New Star lasers and the latter being designated for Lumenis lasers).

Ironically, IQ’s fifth generation fiber after BlackHole™ -- ProFlex™ LLF with Pulsar™ HPC -- is the single most generally compatible fiber design we have ever produced, or that anyone has ever produced for that matter. But because we recognize the value of performance, we’re also the only company that makes 3 different small core fiber designs for three categories of holmium lasers (not including non-SMA terminations like Trimedyne compatible fibers). Specialized fiber designs simply perform better, but more importantly, they offer consistency of performance and reliability that is second to none.

Specialized designs do cost a bit more to produce and IQ’s exclusive (we invented some of the instruments) and 100% in-line production and quality control increases the ProFlex LLF price tag. But while performance and quality do cost more, they pay back many times over in the operating room.

 

“Caveat Emptor” – Ancient Roman Laser Salesman

There are fundamental real reasons why lower priced fibers are priced low. Without studying the fiber we may not be able to tell you, with certainty, what those specific reasons are, for that specific fiber. We can tell you that the principle cost for the raw material is energy; not matter, just energy. You see, the melting point of silica is 1800°C (>3200°F) and silica is melted over and over again in making AFS fiber while energy costs are about the same everywhere, for everyone. Material (sand) and labor are negligible components so everyone in this business starts on a very level playing field.

Regulatory and quality control costs are substantial, particularly for a start-up and when launching a new product, when done by the book. Some manufacturers find shortcuts to compliance, but remember what thermodynamics teaches us: ‘there is no such thing as a free lunch’. One typically must first fully comply with regulations before one truly comprehends what the required controls can actually accomplish, and why they work. If your supplier views FDA as an impediment, or bristles at ‘too much government control and regulations’, they don’t really understand what engaged compliance can do for the bottom line in the long term but are likely focused solely on short term profits. This should give the consumer pause…

“Bargain fibers” are exposed as far more costly in the larger scheme of things when one takes a full accounting of costs of laser URS – including operating room time and personnel, laser and scope maintenance and repair. The costs of fiber damage to ureteroscopes is so high, in fact, that several disposable scopes have come to market of late, e.g. Boston Scientific’s Litho-Vue™ single use ureteroscope. Cheap fibers gouge, cut and pierce channel liners. Even though cheap fibers also sometimes blow the scope to smithereens, the routine scratching and cutting damage is more than enough to justify using a higher price, premium fiber that does not damage the scope one iota.

While negative arguments are valid and should be sufficient rationale to at least accept our free sample fibers for evaluation, there are positive arguments that should be equally as compelling. ProFlex™ LLF’s Pulsar™ HPC delivers more laser energy to the working tip than bargain fibers do at the same laser output parameters, and ProFlex LLF fibers are rated at higher maximum average power than most competitive devices (and lower than none), e.g. ProFlex LLF 200 is rated to 30 watts in full deflection where SureFlex™ 200 is rated at just 12 watts.

The superior efficiency of ProFlex LLF does not end with the working tip because our Smooth Passage™ tip is not just about passing deflected scope channels under full deflection; it also shapes the fiber’s output beam profile to minimize the interaction between the irrigant and the laser energy (Part 8). So not only is there more energy emitted by the fiber, more of that energy actually does work. (Stone dusting and fragmentation are thermo-chemical processes. Making steam bubbles offer no benefit at the relatively long pulse widths of holmium lasers because there is no sonic shockwave effect. Those who claim that there is a sonic component simply do not understand lasers or are conveniently confusing short pulse lasers like alexandrite and FREDDY™ lasers with long pulse holmium lasers.)

 

Using a ‘bargain fiber’ in laser URS, instead of a ProFlex LLF, is akin to entering the Monaco Grand Prix with a Corvette versus an F1 racer: you’ll reach the finish line, but everyone else will be at the after party when you finally do.

 

“Just one more thing, before I forget” -- Columbo

We’ve tilted at one particular windmill for some twenty years with nothing to show for it but a broken jousting lance. Like “the Man of la Mancha”, I choose to tilt on herein, but we could really use some help (We’re running out of lances and our horses are tired and hungry).

Some companies continue to label their 242μm and 272μm products as 200μm when they are clearly not 200μm core fibers. These days most of these companies will call out the true core as well, but they hide it deeply within the IFU. In the past these companies have argued that the fibers were so named when there was no true 200μm fiber. That may be so, for one company, or maybe two companies if you stretch it a bit, but 200μm fibers that really are 200μm were introduced twenty years ago (by IQ in 1996).

If IQ had our way, all companies would get together and harmonize our labeling to call out the glass diameter (cladding rather than the core, since that is directly proportional to stiffness) and the buffer diameter (this total diameter is directly proportion to irrigant flow occlusion and, given in French, indicates working channel compatibility). The core diameter is only of interest to the urologist if s/he’s has read my Part 8.

Doesn’t the continued practice of mislabeling these products seem just a teensy bit dishonest? There is, after all, a substantial difference between 242/272μm fibers and 200μm -- ~25% flexibility in fact – the difference between retention of full deflection and loss of some 20 or more degrees of movement. I don’t know about you, but when I find someone misrepresenting the truth once, “I worry. I mean, little things bother me. I'm a worrier. I mean, little insignificant details…” – Columbo

...and while we fully understand that there may be a price to be paid in changing a product name, and we certainly don’t intend to besmirch any otherwise ethical manufacturers’ reputations, it has been our experience that, when one gets down in the dirt with others, one tends to adopt their odor fairly quickly. This may be a quixotic opinion, but if you happen to agree, the consumer has the most power to affect change.

Let’s further resolve to keep laser URS free of counterfeits and shoddy products

Call us naive, but we like to think that the majority of holmium fiber manufacturers are similar to IQ in their dedication to producing safe, efficacious and quality products, at fair prices. When the occasional rotten apple does turn up, we are hopeful that the forces of the free market will cull them from the barrel before the rot spreads. In the past, perfectly viable surgical techniques have lost favor and essentially disappeared due to bad actors flooding the market with shoddy products to make a quick buck.

I’ve made reference to ‘garage made’ fibers in the past, and believe me; they do exist, even to this day. As one who exposes himself freely and as broadly as I can to spread the word on quality (yes, even to my competitors), I get e-mail and calls from surgeons all the world over, asking for advice or for my diagnosis regarding a particular failure mode. Al large proportion of these calls describe such fibers.

For example, an East Coast urologist recently e-mailed about a ‘milky and gelatinous substance’ oozing over the face of his new fiber connectors, even before using them.  (The stuff burned to brown-black when he used the first few without noticing the goo.) This was most likely a ‘garage made’ fiber where a cold-flowing adhesive had been used inappropriately. If I had had the fiber to examine personally, I could have provided a full forensic report in support of obtaining a refund, or even a civil action, if warranted.

I am an analytical chemist (you know, the kind of scientist those actors in forensics dramas pretend to be, but I can actually pronounce the instrumental techniques correctly). I have also served as an expert witness for US District Courts (in surgical fiber optics design for patent disputes) and as a forensic chemist in wrongful death cases. If you find what you suspect to be a garage fiber, send it to me with the original packaging (if you’ve got it, and preferably sealed/sterile in the original packaging); I’ll analyze its construction in detail, verify its provenance/legal status and send you a full report, if you’ll agree to allow me to publish my findings. You can opt for anonymity and I’ll respect your wishes. Testimony in civil actions is also available, but this service is necessarily billable.

Anecdotal reports of suspect counterfeits or unusually shoddy products are also welcome.

Thank you for reading,

Sephen

 steveg@innovaquartz.com                                       main phone: 623-434-1895, lab x101

Omnipulse™ is a trademark of Trimedyne, Medilas™ & MediLas™ H20 are trademarks of Dornier, StoneLight™and BlackHole™ are trademarks of Laserscope/AMS/Boston Scientific), Litho-Vue™, AccuMax™ and Flexiva™ are trademarks of Boston Scientific, VersaPulse™ and PowerSuite™ are trademarks of Lumenis, Litho™ is a trademark of El. En./Quanta and Odyessey™ is a trademark of Convergent while FREDDY® is a trademark of World of Medicine. ProFlex™, ProFlex™ LDD75, ProFlex™ LDDE, ProFlex LDDER, ProGard™, Lotus™, ProFlex™ SPY, Pulsar™ HPC, Smooth Passage™ and Fiber IQ Test™ are trademarks of InnovaQuartz LLC. © 2016, InnovaQuartz.