Survey for developing a device that minimizes clicking sound (follow-up to interviews in Spring)

[kreagen]

Hi all,

I'm Kaitlyn, a senior in biomedical engineering at Purdue University, and I had the pleasure of talking to many of you last spring about your experiences with the mechanical heart valves and the clicking sound they make. Your guys' input was super valuable for our project, and we are now moving on the the next stage of the project. My team and I are currently working on developing a device that will suppress the sound. We are currently throwing two ideas and we would love some patient feedback on which one you guys would prefer and have created a survey to gather some information. In addition, by getting your input on device type, we will be collecting demographic data on heart valve replacement patients. (Only demographic data, no identifying information is included). We hope that this data can help us understand why some patients don't hear the clicking and why for some, the clicking impedes their lives. The survey covers both demographic and device preferences. The survey does not need your name or any other identifiable data. It also does not require any contact information. All questions are optional, but any questions that are answered honestly will help us develop a device that fits everyone's needs. The survey will only take a few minutes.

The options are a wearable device or a subcutaneous implantable device. A wearable device will likely be much cheaper and user-friendly. It will also be much quicker to develop (fewer FDA approvals needed). But a wearable could be bulky and could be visible under clothing as it would have to be located on or near your chest. A subcutaneous device that is implanted under the skin will likely be more expensive, minimally invasive, and might be less user-friendly. However, it could be more comfortable, less bulky, and won't be visible under clothing. It also will take longer to develop as clinical trials would be required.

Survey: Demographic Questions

 

[Superman]

To lend a little credibility (for whatever goodwill I’ve built up here anyway). I was able to meet kreagan in person last year when I was on a college visit with my son at her University. The survey is legit. She’s a student and working on the project as indicated.

 

[pellicle]

The options are a wearable device or a subcutaneous implantable device. A wearable device will likely be much cheaper and user-friendly

could you even explain how this is even physically possible?

I mean its not like its a balancer shaft on an internal combustion motor, then there's propagation delays ... I'm genuinely struggling here.

 

[Unicusp]

Sounds like implantation of a piece of sound deadening insulation under the skin and over the valve area. Simple and possibly somewhat effective.

 

[Dana]

A wearable device that is a sound insulator may help attenuate clicking for the person sitting across the table from you but I doubt that it would diminish the sound the patient hears because that sound is likely transmitted through internal sound conduction pathways.
Last year I made a post, half-in-jest, about using noise cancellation ear buds for people whose sleep may be disturbed by the sound. But now that someone is actually working on possible techniques, this might be one to consider. It would need a microphone and maybe a bluetooth link from it to the earbuds which would cancel out the waveforms to the patient. Or one could wear a bluetooth speaker that emits the cancellation waveforms to the external environment. Or both.
What about people with pacemakers that have a natural sound insulator built-in, i.e., fat? If one tested a person with a thick layer of fat on the chest and measured the sound emitted externally and also what the patient hears internally, it would provide evidence on whether insulation works for internal noise, external noise or both. Wait, actually the PM is probably always inserted on top of any fat.
Anyway, just some thoughts... Good luck Kaitlyn. As far as the survey goes, where is it? Personally I just live with the sound.

 

[pellicle]

Simple and possibly somewhat effective.

Anything like that would he a harbour for infection

 

[pellicle]

Personally I just live with the sound.

Agreed

 

[Unicusp]

A wearable device that is a sound insulator may help attenuate clicking for the person sitting across the table from you but I doubt that it would diminish the sound the patient hears because that sound is likely transmitted through internal sound conduction pathways.
Last year I made a post, half-in-jest, about using noise cancellation ear buds for people whose sleep may be disturbed by the sound. But now that someone is actually working on possible techniques, this might be one to consider. It would need a microphone and maybe a bluetooth link from it to the earbuds which would cancel out the waveforms to the patient. Or one could wear a bluetooth speaker that emits the cancellation waveforms to the external environment. Or both.
What about people with pacemakers that have a natural sound insulator built-in, i.e., fat? If one tested a person with a thick layer of fat on the chest and measured the sound emitted externally and also what the patient hears internally, it would provide evidence on whether insulation works for internal noise, external noise or both. Wait, actually the PM is probably always inserted on top of any fat.
Anyway, just some thoughts... Good luck Kaitlyn. As far as the survey goes, where is it? Personally I just live with the sound.

I am lean with no fat, just muscle. Some nights when I go to bed, I can hear the clicking. I put a light blanket on my chest and no longer hear the noise. So, for me it's external noise thru the chest wall to my ears.

 

[LondonAndy]

I am in the fortunate group who, since day one, have hardly heard my mechanical valve. I am a fat guy, so not sure if that has helped, but also I am sure I remember reading somewhere that the size of the valve is relevant - a larger valve being quieter than a small one, presumably because a given volume of blood flowing through it is going slower than a small valve and so the opening and closing of the "leafs" is slower. Anyone else remember seeing that?

 

[tommyboy14]

Hi Kaitlyn,

I have my On-X for just over a year now and I hear it most of the time. Sometimes it can get loud, but I got used to it. It hasnt disrupted my sleep thus far.

A Germany company called Cardiosignal actually delevoped a Thrombocheck device, which is a device to check if the valve is about to throw a clot based on changes in the sound patterns of the valve. There is research to suggest that this is a reasonably good early indicator and some hospitals in Germany have intervened early and helped patients to prevent the stroke before it even happened.

http://www.cardiosignal.de/index_en.html
Could your prospective device be used to monitor the development of a clot on the valve?

I think it if it did that, you could sign me up for a pre-order.

Thank you for your research in this area.

Tommyboy

 

[JLmatus]

I've had my On-X valve for over 6 years now. I have a lean build. I honestly don't notice the noise at all. I did for the first month or so. But now I don't even know it's there, unless I think about it. Also, I would think that the noise is coming from more internal sources than external.

 

[Protimenow]

Hi all,

I'm Kaitlyn, a senior in biomedical engineering at Purdue University, and I had the pleasure of talking to many of you last spring about your experiences with the mechanical heart valves and the clicking sound they make. Your guys' input was super valuable for our project, and we are now moving on the the next stage of the project. My team and I are currently working on developing a device that will suppress the sound. We are currently throwing two ideas and we would love some patient feedback on which one you guys would prefer and have created a survey to gather some information. In addition, by getting your input on device type, we will be collecting demographic data on heart valve replacement patients. (Only demographic data, no identifying information is included). We hope that this data can help us understand why some patients don't hear the clicking and why for some, the clicking impedes their lives. The survey covers both demographic and device preferences. The survey does not need your name or any other identifiable data. It also does not require any contact information. All questions are optional, but any questions that are answered honestly will help us develop a device that fits everyone's needs. The survey will only take a few minutes.

The options are a wearable device or a subcutaneous implantable device. A wearable device will likely be much cheaper and user-friendly. It will also be much quicker to develop (fewer FDA approvals needed). But a wearable could be bulky and could be visible under clothing as it would have to be located on or near your chest. A subcutaneous device that is implanted under the skin will likely be more expensive, minimally invasive, and might be less user-friendly. However, it could be more comfortable, less bulky, and won't be visible under clothing. It also will take longer to develop as clinical trials would be required.

Survey: Demographic Questions

'You guys'? Really?
I suspect that if your draft report said 'you guys'' it would be sent for rewrite.

 

[Protimenow]

I don't think a device like this is worth the trouble developing. As others said, we just live with it.

A 'noise canceling' device couldn't work predictably - it would probably be based on a somewhat stable heart rate, or would sense the heart beat and 'cancel' the sound a few microseconds after it begins. Putting anything under the skin (if not embedding it a bit deeper) creates more risk of infection and would eventually need to have a battery replaced -- in terms of battery usage for a device like this, because it's probably generating some kind of signal, it probably uses much more current than, say, a pacemaker.

And I suspect that even deaf people hear the click (if they focus on it) through bone transmission.

I don't know how big a market there will be for a thing like this, or if it's even worth creating an actual product (other than as a Graduate project), and doubt that it could be commercially viable.

My clicking doesn't bother me enough to risk implanting a device, and I probably wouldn't wear something that suppresses or cancels the ticking of my device. And, FWIW, I monitor my heartbeats because I have arrhythmias, and having something audible to follow is an advantage, rather than a disadvantage.

 

[Gail in Ca]

I’m a thin woman, my Carbomedic top hat 25mm valve sounds like a basketball hitting the wood floor. It seems loud and forceful, yet it never keeps me from falling asleep. I’m more aware of it while playing soft passages in orchestra. The closest guy to me only thought it was someone’s watch. I feel it in my throat at times.
A few years ago I stayed at a beautiful condo right on the sand near Monterey Ca. The sound of the ocean’s crashing waves totally drowned out my annoying valve. I was in heaven! Unfortunately, I cannot afford to buy one of these beach homes, but I’ll always remember that stay.

 

[Superman]

Well done survey. Nice and brief and to the point. I think when considering any solution (assuming it’s a problem for some), one also has to consider whether or not the healthcare system would see it as enough of a problem that it would be a covered procedure. If it were covered, non-invasive or obtrusive, and guaranteed silence, I might be interested.

I’m not sure a wearable will do anything as others have pointed out. It’s really hard to explain the sound to someone who doesn’t have experience. But it’s inside you. I don’t hear a noise like a clock ticking. And plugging my ears changes the tone, but the sound is still there. Putting my hand over it just amplifies it. Like it echoes off my hand and sternum.

But I suppose my lack of imagination is why I do what I do and not engineering.

 

[pellicle]

It’s really hard to explain the sound to someone who doesn’t have experience. But it’s inside you. I don’t hear a noise like a clock ticking. And plugging my ears changes the tone, but the sound is still there.

indeed and I think that those who have it are still exploring the issue too.

Hearing is something so innate that few people actually consider it deeply. I recall (when I did a diploma in Audio Engineering) going into an Anechoic room at a University engineering department. It was quite an experience having no sound reaching you except from direct from a source (no reverb or room presence) and your own internal sounds. I noted instantly how I could hear my own breathing like when I was scuba diving.

Few people think about acoustics let alone study it. Here is a practical example:

 

[pellicle]

I’m more aware of it while playing soft passages in orchestra.

I bet the bloody thing isn't keeping the right time signature!!

 

[pellicle]

As others said, we just live with it.

I've noticed now that younger generations of adults are increasingly suffering from vanity, denial, entitled to be perfect and an expectation that they should grow old like the movie stars present themselves as doing. Perhaps its a function of my age, but I prefer to think of it as a function of "when I grew up".

My grandfather got his thumb very badly damaged (all but ripped off) in a motorcycle accident, this was in about the 1950's. The surgeon knew him well and made sure to save the thumb no matter how semi functional it was. I never heard him once remark about it nor be self conscious about it while whipping the arse of 30yo's on the tennis court. He was a grazier and of course a bit of a farmer too.

I know a local guy here who's a logger and saw mill operator, he just about got his arm torn off one day and managed to live. Likewise he doesn't moan about this but rather celebrates each and every day that he's alive instead.

This last point is seemingly downplayed today (that we are alive and well instead of dead).

A friend of mine took (and eye bleedingly) processed this image of me talking with the gentleman about engines (while holding the cylinder lining).

for the interested this engine has no "head" but has opposing pistons

Me, I'm one of those who jokes about my scar, and is just bloody happy to have had 3 surgeries that have kept me alive.

I call this being grateful for what society has given me and have accordingly done the best I can to enrich the lives of those around me as a vocation. That I continue to work on pragmatic things such as helping INR management is just one aspect of that.


Best Wishes

 

[Gail in Ca]

Yeah, generally it’s beating like crazy, thumping, like my body is moving because I still get nervous performing after so many years! So, we play a slow passage and my heart has its own thing going on especially in a-fib! So fascinating that I’m able to enjoy playing in this symphonic wind band with all that going on in my chest!! At the last dress rehearsal, I was late, which I’m never late.
So, the group is playing, sounding unbelievably beautiful while I’m quickly putting my clarinet together and unfolding my stand, getting music set up, etc. My heart valve is pounding, I’m taking deep breaths, trying to only hear the sounds around me. It mostly works. Then I’m ready to play and I’m in the zone with everyone else, my valve is no longer taking Center stage, yay!

 

[pellicle]

it’s beating like crazy, thumping, like my body is moving because I still get nervous performing after so many years!

well at least you have a good bio-feedback system to allow you to work on your "self calming".

I'm sure you know that performance is best done when calm.

I'm glad you're back into your music and the performance art that it is.

Best Wishes