Apply HN: Infection Resistant Materials for Preventing Infections | Hacker News Reader

Apply HN: Infection Resistant Materials for Preventing Infections

27 pointsjonwachob9131 comments

--- What we do

Using the properties of nanostructures we can create low-cost polymer nanotextured surfaces that are anti-microbial, prevent biofilm formation, reduce protein absorption, and increase blood biocompatibility, leading to increased patient outcomes through reducing healthcare associated infections.

1 in 20 patients that receive a central line catheter get an infection because of the catheter, about 7000,000/year. 1 out of every 10 that get an infection will die, about 70,000/year - these are stats from the CDC. We are nanotexturing the interior of a catheter to prevent platelet adhesion and thus clotting and the exterior of the catheter to prevent bacteria from getting close the catheter site.

- How?

Nanostuctured topography creates mechanical stress on settling bacteria. Nanoforce gradients caused by the surface variations induces stress gradients within the lateral plane of the surface membrane of a settling microorganism during initial contact. This stress gradient disturbs normal cell functions, forcing the microorganism to provide energy to adjust its contact area on each topographical feature to equalize the stresses. This expenditure of energy is thermodynamically unfavorable to the settler, inducing it to search for a different surface to attach to.

TLDR; microorganisms can't find a surface to rest on.

In preliminary testing we found a reduction of platelet adhesion by 82.3% over the control and 84.9% over the positive control. Staph. E. observed an adhesion reduction of 68.6% over the control and 81.2% over the positive control. Staph. A. (also known as MRSA) had a reduction of 64.6% over the control and 83.7% over the positive control. E. Coli had an 84.1% reduction over control and 97.5% over the positive control.

- What's our Secret Sauce?

Not the technology... Nanostructure manufacturing has been around for decades using lasers, heat, and/or pressure to texture a surface. My startup has developed a new method for texturing a polymer surface without lasers, heat, or pressure. We developed the process (accidentally) while working in a material science lab at the University of Central Florida's Nanoscience Technology Center. We are currently patent pending (no publish). Traditional manufacturing processes often require a clean room and can cost over $300/sq in. Our process doesn't require a clean room and costs about $1/sq ft.

- Is our Secret Sauce repeatable and scalable?

We have textured hundreds of samples (by hand), and are working on designing an automated process that can replicate our process and eliminate human error.

- Funding to date?

After the accident that lead to the new process we applied to and have received funding from the National Science Foundation to continue research. We have applied to additional National Institute of Health and Center for Disease Control grants, but they aren't suitable for building a startup. Yesterday we submitted a grant worth $225K, but we won't even know if we get the grant until September, not exactly a system that is good for funding startups. They are great for alleviating costs for product R&D but that's about it.

- What's our team look like?

Brandon - He's the inventor of the process and the omniphobicity expert. Dr. T - Is our Science lead and material scientist. Myself - I play with data and do the business side.

We started with the idea of a self-cleaning film for solar panels, while the technology worked the finances didn't. Solar is an industry trying to drive costs down, not add another $20 to the price of a panel. It shocked me, but that was the general consensus from the industry (SunPower, SunTech, Solar City, and many more).

Questions?

1. Is there a limit on the material that can be used to make the pattern?

2. With your catheter can you use the same plastic that is being currently used so all you are changing is the surface structure?

Thank you for the questions!

I can answer both your questions at once. We are limited to polymer materials. HOWEVER, certain plastics have reactions that MAY have toxin issues. PVC catheters were phased out because new materials were developed that have better bio-compatibility. We can texture the PVC catheters and achieve similar results as what we've already seen.

*Polyethelene is a common material for catheters, and while we can texture it the material forces us to add heat to the equation. Removing heat is a critical step that we removed cause it's time intensive. WORST case scenario, our method with heat is still cheaper and faster then current nanotexturing methods.

I really like the idea, but I will caution you to not get overly confident that this process will be a permanent solution. I know a little something about infection control and biofilm. In a nutshell, when antibiotics were discovered, they announced it was the end of disease. Fast forward a few decades and the current reality is that we are dealing with scary super bugs that are antibiotic resistant.

Infections are living organisms. Thus, keeping them at bay will always be an ongoing battle. And battles evolve. As each side learns new tactics, old tactics stop working.

So while new materials can play a role in that, I believe new processes will play a bigger role. I will suggest that, as you develop your products, you do so with an eye towards ease of use in terms of properly flushing them, cleaning them etc. If you can make it easier and more convenient for people to clean them, insert them in a manner that keeps them sterile and so on, this will have more lasting value in the battle against infection than merely upgrading the material.

But thank you for working on this vital area. I wish you nothing but good luck.

Hey, sorry for the late response, but I was fielding this question around the lab to get thoughts.

The general consensus is that because we aren't relying on biology to prevent the spread of infection but rather the physical chemistry the likely hood of the bacteria evolving is significantly lower.

Our goal isn't to prevent all bacteria to sticking to all surfaces (forcing them to evolve), but rather to control what areas they do stick to. We just want the bacteria to hang out away for areas that can lead to infections. If we coat a door handle in our polymer films, the bacteria will simply fall to the floor, it is really unlikely for the bacteria to make it's way from the floor to a nurses shoe to a patients vascular catheter, then the bacteria is killed during the daily mopping of the floor, so I've done my job of herding the bacteria until it can be killed.

Well, I think you have completely missed my point.

Whatever you do, let me suggest that you be incredibly careful to avoid implying that use of this new and improved material means you can slack off on other hygiene practices. If you market it as a means to not have to bother with cleaning as regularly and that sort of thing, or even if you fail to rebut this assumption that other people will almost certainly make (that they can clean less because it is germ resistant -- which a lot of people think means germ proof), you will be practically guaranteed to eventually grow a superbug.

And I hope you take that seriously. I am not trying to shoot down your product. I just know something about this stuff.

Best of luck.

How far would the YCF get you?

From you comments, it sounds like your immediate areas to look into are:

- Options for getting FDA approval

- Licensing vs self-Manufacturing

- Determine whether catheters are the right launch product

- Getting your ducks in a row so that you can do some sort of deal that gives you enough money to execute on the above (that is, start an FDA trial, build up a manufacturing capability, etc as needed)

Does $20k and 8 weeks get you to that point? Or are you planning to use the YCF time to tackle a different set of problems?

Or, to phrase it differently: Why is YFC the right next step for you?

Note: I like what you guys are doing, and I really like that answers you've provided so far. I'm mostly just asking questions to help you flesh out/present your ideas clearly.

Our immediate area to look at is do we have a business or a license? And what is the best product for us to invest in? A catheter may be the easiest, but funding may be more readily available for heart valves or stents.

That being said, we'd like to spend at least half the money on additional testing. Primarily how the structure size and pattern effect adhesion. Pillars w/ points vs pillars with flat tops, or any other geometry? 600nm vs 60nm? Whats the optimum gap spacing? And after all that how do the same tests we've already performed compare?

What are people already doing in this space?

Specifically, are there any technologies out there or in development that aim to reduce infection rates related to the use of medical devices?

What remediation processes are used to reduce infection rates, that are not technology based? What is the cost for these, and how does that compare to the cost of using your technology?

I really like the idea of improving outcomes by simply swapping out one piece of equipment for a better piece (especially as you are not making the process more complicated, it's a straight upgrade).

Thank you for the questions!

Sharklet developed a micron sized pattern for use on catheters, and has licensed the pattern to Cook Medical. But the transaction was completed a few years ago (2013) and nothing has come to market. There is no clear evidence why this is, but we do know they are using pressure stamping to texture the catheters, a process that is still expensive and time intensive. Their patent didn't cover manufacturing, just the texture pattern. Inaddition to our lower cost manufacturing, we can texture at the nano-scale. Bacteria tends to be 1-3 micron's in size, any surface bigger then them and they can rest and attach. Because Sharklet/Cook use a micron-scale pattern some bacteria can still adhere, you still get a deep reduction in bacteria adhesion but it's not better then what we can observe at the nano-scale.

The CDC, and hospitals, are primarily turning to better processes. Ensuring that central line catheters are routinely cleaned, no clots are forming, little things like that. Try and identify any clots early to give maximum time to get a new catheter. Conduct additional testing to look for infections and treat as early as possible. Those are all things that hospitals can easily do and have been doing quiet well, it's just not enough. Catheters are incredibly price sensitive, they are treated like a commodity and no one wants to pay any extra then they have too. Adding and additional few pennies to the overall cost would have hurt us a few years ago. But the Affordable Care Act is our friend, ANY infection that a patient can connect to a hospital (whether it's the hospitals fault or not) has to be treated and paid for by the hospital. All of a sudden a few extra pennies now can save a hospital tens of thousands later. Our financial story won't depend on an out-price cost comparison, but a reduction of later hospital expenses (not sure the correct finance term for that).

This sounds awesome

You mentioned that your process doesn't require a clean room. What are the regulations around getting a catheter "approved" for human use? Do you need to run some expensive trials or is this something that you can scoot around?

ie. If I wanted to use your catheters tomorrow, other than a repeatable manufacturing process whats stopping me from ordering a few thousand and putting them to use?

We know that it does need FDA approval and trials. What we are hoping is that we can file what is known as a 510(k). A 510(k) is a process where we tell the FDA "Hey look at these guys, we are doing pretty much the same thing" and we can skip most of the hard and expensive part. We don't know yet if we can file a 510(k) or if we need to go through the whole process.

I work in infection control and conduct CLABSI and SSI surveillance daily. Have you tested your application method on implants?

I'm assuming you mean stents and artificial heart valve type implants. The short answer is no, however we have identified those implants and want to research applications on them when we have the resources to do so.

If you mean something else can you clarify?

Thank you for the question!

Prosthetic joints and ortho hardware (pins, rods, screws).

We haven't explored an application for ortho hardware and I don't know that much about the space. But I'll certainly go out and learn more, and when I say me I mean I'll ask a guy who has been helping us who has his masters (w/thesis) in Orthopedic Biomedical Engineering. Hell maybe he can even us that as his topic for his Ph.D :D

It's a huge area. In 2011 there were nearly 1 million total joint replacement procedures in the US alone (that doesn't include many other type of procedures involving hardware)[1]. Rates of infection are around 1-2% depending on the joint. Many infections can be treated with antibiotics, but many need the joint replaced. Replacement means another procedure that carry risks and costs. Therefore, prevention of these infections is key. Most of these infections occur as a result of biofilm formation on the surface of the artificial joint. Seeding of these biofilms occurs either through break in sterile practice during the operative procedure or from a BSI or some other systemic infection. Either way, surface improvements could drop the SSI rate, and therefore drop associated costs.

1 - http://orthoinfo.aaos.org/topic.cfm?topic=a00233

Probably my favorite so far. What is the business model and how do you get your first customer?

Thank you for the vote of confidence :)

The first customer is our easy part. We've already signed up Florida Hospital, the nations largest hospital (3,282 beds at one campus) to agree to be our clinical trial partner when we are ready. Obviously that's a ways away, but they are on board. IF the trials are successful they'll be our first customer.

The business model is something we don't know about yet. Using the YC Fellowship money we want to go out and further understand where we fit in; can we license, do we need to do this ourselves, what is the most profitable business model, what is the lost cost to market model, etc. We haven't been on this for very long, it was over a year that we spent trying to figure out were we fit into the solar market (with no funding) before we learned it's not a good market just because a $20 price increase per panel. It was 2 months ago that we pivoted to infection resistant materials and wanted to find out if the science worked. Well it does and now we feel comfortable committing real cash into understanding our model.

My humble opinion, this is a license play. You don't want to get into manufacturing catheter's. Leave that to Bard et al and let them implement your process.

You may be correct, but playing this out. GE isn't in the catheter business, maybe they are willing to commit cash for an acquisition so that they can get into the catheter business. With a powerful strategic partner manufacturing may be the way to go.

But that's one of the things we need to learn - are there any big players not in the market that want in and will commit real money to do it?

I'd rather not lose money because we didn't do that work now. At the same time, what is a Cook Medical and a Bard looking for in a license? Where do we need to be at, what tests do they want data for? Are they looking to invest in the catheter space?

I've just spent almost three weeks in hospital.

I went in for routine elective surgery and a two night stay. I ended up in for around three weeks after post-operation infection. Fortunately, it wasn't MRSA and easily controlled with antibiotics (some of which I had a bad reaction to.... good times). At home now, but still having the dressings changed on open wounds.

This idea gets a big up vote from me. Reducing the risk of infection could have had a massive positive impact on my life over the last month.

Did the hospital tell you what the source of the infection was?

No, and I'm not sure they knew.

Basically, I had the operation, spent two nights in hospital and came home for two nights. The second night at home I had severe headache, elevated temperature, swelling around one of the wounds, redness and heat. Basically, the fun of an infection.

Back to hospital, they cut me open, cleaned me up, put me on IV antibiotics and kept me in for another two weeks.

I suppose the infection could have been something I picked up at home or could have been some instrument not properly sterilised. The surgeon said they have about one in 10,000 who get an infection after the type of operation I had. If it was poor sterilisation in the workflow somewhere, I could hope your startup might have been able to have reduced the risk there.

This sounds very promising to me, but I know almost nothing about this field.

How does the cost of one of your textured catheters compare to the cost of an existing catheter? Would the additional savings in antibiotics and deaths negate that cost?

Do you have an estimate of how many fewer infections would result from using your textured catheter? (I don't know if infections only happen if you cross some threshold on the number of bacteria.)

Do you have anything you can share with actual numbers and analysis? Has an outside lab reproduced your findings?

1. Ours does cost a few pennies more, which is a big deal for catheters. ANY increase is hurtful. HOWEVER the Affordable Healthcare Act works in our favor. Any infection that a patient develops and can connect to the hospital, regardless if it's the hospital's fault or not, has to be paid for by the hospital. This treatment can often cost tens of thousands of dollars. It's better to spend a few extra pennies now and avoid spending tens of thousands later.

2. Really god question that we aren't sure about yet. As we learn more we expect to be able to answer this.

3. https://www.dropbox.com/s/dqnl3d7dalj08yo/Preliminary%20Data... <- a quick 1.5 pager about how we did the testing. Remember these were preliminary tests. An outside lab has not tested to replicate our results, we are a little early for that, but we are actively looking for university research labs that we can do sponsored research through to help with a lot of the testing.

This sounds pretty great. The question I would have is whether the nano texture may or may not damage the inside of the body. Will it tear the tissue it's going through in a different manner than a non textured material. This could make the insertion harder and the healing process longer.

It shouldn't. The nanotexture pattern we used on the preliminary testing was super-hydrophobic, the texture pattern we are going begin testing in a few weeks should be ultra-hydrophobic. These high phobicity rates mean they are slick and minimize friction. Tissue should slide across the nanostructures with minimal friction and no damage.

Can you use the same technique to produce mold-resistant plastic for showers and baths?

YES!

But the grout has us a little confused. Ya know, because it's not plastic and what not. We could make a film to place on top of your grout, but we aren't sure about that yet. We are afraid that when we nanotexture the floor of a shower (or apply a polymer film on top of the tile) that the surface will become a hazard to someone trying to take a shower*.

I'd also like to see this on my toilet seat, so I can be lazy and not lift the seat up (lol). We did do contact angel testing and imaging of urine on the structures but left it out of our analysis since it didn't apply to catheters. The contact angel's were GREAT, and the images looked good, but again we didn't do a real analysis of the results.

EDIT: included the comment about nanotexturing the floor of a shower.

We are afraid that when we nanotexture the floor of a shower (or apply a polymer film on top of the tile) that the surface will become a hazard to someone trying to take a shower

You mean because it's slippery? If so, don't worry about it. My shower floor (plastic, not tile) has ~millimeter-sized bumps that make it not slippery at all.

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