Tiny Pacemaker Can Be Installed Via Catheter

the_newsbeagle writes "About four million people around the world have pacemakers implanted in their bodies, and those devices all got there the same way: surgeons sliced open their patients' shoulders and inserted the pulse-generating devices in the flesh near the heart, then attached tiny wires to the heart muscle. ... A device that just received approval in the EU seems to solve those problems. This tiny pacemaker is the first that doesn't require wires to bring the electrical signal to the heart muscle, because it's implanted inside the heart itself, and is hooked onto the inner wall of one of the heart's chambers. This is possible because the cylindrical device can be inserted and attached using a steerable catheter that's snaked up through the femoral artery."

This is exciting..

[mulvane]

The things we can do now adays in medicine are shocking...

Re:Catheter?

[Russ1642]

Yes, it's a urinary catheter. To get to the heart. The two are directly connected, similar to your case where the brain is directly connected to the asshole.

Re:

[newcastlejon]

Should they call it a "pissmaker"?

They're probably saving that for the artificial kidney.

Re:

[Jeremiah Cornelius]

PissTake(tm) The artificial kidney and bladder system, that gives as good as it takes!

Believe me, urine for a treat!

Re:

[Anonymous Coward]

The things we can do now adays in medicine are shocking...

I had a technique similar to this done almost 8 years ago. It was a radio catheter ablation done to correct atrial fibrillation. They went up through my groin and burned scars around my exiting heart valves to stop "Stray Voltage" in my heart. My heart hasn't skipped a beat since, and I was out of the hospital in just a day or two. This seems like a very logical next step, I can't imagine how much pain this is saving the patients.

Re:

[Hognoxious]

The things we can do now adays in medicine are shocking...

Sadly there's no cure for junctural metanalysis [wikipedia.org]

Not as exciting as it used to be

[tlambert]

The things we can do now adays in medicine are shocking...

The article claims the thing can last "up to 13 years" before having to be replaced.

In the past, we used Pu-238 RTGs called "Plutonium cells", and the pacemakers never had to be replaced.

I guess this step backwards, towards treating pacemakers as a treatment, rather than a cure, guarantees a recurring revenue stream. One wonders, given the industry that surrounds it, whether we will ever get a cure for anything that started out with just a treatment, such as diabetes, when there's so much money tied up in

Re: Not as exciting as it used to be

[ColdWetDog]

Maybe, perhaps, it's easier to treat a discrete problem (fast / slow/ intermittent ) heart rate than to solve the rather difficult problem of aging.

Think about it. They're not really after you.

Re:

[joseph90]

The things we can do now adays in medicine are shocking...

The article claims the thing can last "up to 13 years" before having to be replaced.

In the past, we used Pu-238 RTGs called "Plutonium cells", and the pacemakers never had to be replaced.

I guess this step backwards, towards treating pacemakers as a treatment, rather than a cure, guarantees a recurring revenue stream. One wonders, given the industry that surrounds it, whether we will ever get a cure for anything that started out with just a treatment, such as diabetes, when there's so much money tied up in "recurring revenue streams" and so little in "pay for it once". The whole SAS field itself is based on it.

The problem with the plutonium cells was that when you died you had to be buried as nuclear waste (or so I was told).

Re:

[CastrTroy]

Why not just have the batteries removed after you're dead. It's not like the operation would kill you. You could probably get it done for free if you let med students do the task for you.

Whew!

[DaTroof]

Ah, through the femoral artery. My imagination went to a much more horrifying place when I read "catheter."

Re:

[Anonymous Coward]

I bet there's a market for electrostim prostate implants, though.

Re:

[Keith111]

I thought that science had finally proven that the path to a man's heart isn't through his stomach once and for all... :(

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[FatdogHaiku]

I thought that science had finally proven that the path to a man's heart isn't through his stomach once and for all... :(

Yes, that was an old wives tale started to deny and suppress the "Happy Penis, Happy Man" axiom...
Old Wives be bitches sometimes...

Re:

[mcgrew]

I thought that science had finally proven that the path to a man's heart isn't through his stomach once and for all... :(

That old canard is misunderstood. The best way to a man's heart is through his stomach if you're trying to stab him to death.

Re:

[david_thornley]

It's bad enough. Ever had a catheter go to your heart?

It starts out fine. In my case, it was to pull a clot out of a coronary artery, and the heart attack pain just stopped very abruptly. Great.

Then there was the staying still for ten hours. I really don't know why it was so bad, but after about seven it hurt more than the heart attack had. When I talked about it to the nurses, they said they'd heard that a lot.

If there is a next time, I'm asking for the painkillers earlier.

Re:MRI

[ChumpusRex2003]

Probably a lot less susceptible.

The main concern with MRI and pacemakers is not so much the magnetic field but the RF field. The magnetic field is not without problems as most pacemakers contain a reed switch which is used to activate "safe mode", where the pacemaker enters a special diagnostic mode. This is largely for historical purposes, as early pacemakers used this for battery level testing. The doctor would hold a magnet to the patient's chest. The pacemaker would enter diagnostic mode and would stimulate the heart to beat a rate dependent on battery voltage. The doc would feel the patient's pulse and could look up the estimated battery level in a table.

Modern pacemakers contain rather more sophisticated NFC capability, so much more useful readouts are available with a proper scan tool (battery voltage, stimulation mode, inputs from various sensors, lead impedances, stimulation voltages and currents, etc.) as well the ability to reconfigure various modes (e.g. vibration response - where the pacemaker increases rate in response to exercise induced vibration), whether the pacemaker can sense other heart parameters (so that different chambers of the heart contract synchronously), etc. In general, however, a magnet will switch the pacemaker into a basic mode of operation. (Defibrillators are different, as basic stimulation can be very dangerous in people with severe heart disease, as it can trigger ventricular fibrillation; therefore magnet mode in implantable defibrillators usually only just tweaks some parameters, rather than anything more dramatic).

The major issue with MRI is the RF field. MRI requires a very powerful RF pulse. A typical MRI power amplifier will take up 6U of rack space, and about 5 gallons per minute of cooling water and need a 3phase 480V power supply, while providing a peak RF power output of 35-70 kW.

A modern pacemaker will typically sense the ECG as well as stimulating. It will include a watchdog timer, and if a beat is not detected before the timer expires, it will trigger a stimulation pulse. One risk with the MRI environment is that the capability of the pacemaker to sense the 1 mV ECG signal may be degraded by the pulsed transmission from the 70 kW RF transmitter 6 inches away.

There are other issues with conventional pacemakers. Being implanted near the shoulder, the pacemaker connects to the heart muscle via leads approx 8-12 inches long. These typically form an arc in shape due to the anatomy. It just so happens that this wire loop forms quite a nice 1/4 wave loop antenna tuned to the scanner's RF frequency; it can absorb the RF energy and channel RF into the tissues around the pacemaker "box" and at the electrode tips. In minor cases, the RF pulses can act as pacemaker pulses on the cardiac muscle. Fine at 1 Hz scan rate. Not so good at 5 Hz scan rate. In extreme cases, the voltage build up across the pacemaker leads can cause RF burns to the cardiac muscle or damage the pacemaker circuitry. (There are MRI compatible pacemakers around which use various tricks - upgrading from normal coax cables to coax with heavy copper screens so rigid that they actually have to be articulated in order to bend + a liberal helping of ferrite beads; or dividing the leads up into 1" segments interconnected by small ferrite transformers)

The nanostim device doesn't have any exposed leads, so it is likely to be much less susceptible to RF problems. Due to size and location, it's also likely that it doesn't feature a conventional magnet mode, relying instead completely on NFC for control and communication. It also has the option of being completely removable. Conventional pacemakers often aren't, as the leads are generally not retrievable from where they screw into the heart muscle. Because it is RF pick-up in the leads that is the No 1 hazard with MRI, simply removing the pacemaker device, but leaving the leads isn't a safe option (it may actually make it worse, as the pacemaker itself often contains clamping and termination circuits to protect itself from EMI, and

Re: MRI

[ColdWetDog]

Best posting on the thread. Tx

Re:

[residents_parking]

Wow - thanks for the detail. I spent two years working on a Defib tester with an option on a Pacer tester and for an EE the details can take some learning, especially when your client is in marketing. Most of the two years was spent grappling with immature technology and on UI, though I did have a bit of fun with pulsed biphasic capture in the early days.

Have you ever considered contributing to Wikipedia?

Re:

[Anonymous Coward]

And, yet, it is our capitalist society which has managed to produce these amazing advances in such a short period of time. 60 years ago a pacemaker weighed 100 pounds and was worn externally. 10 years before that it didn't even exist except in theory. So, hate on capitalism if you want but I like it and wish we'd worry more about getting rid of some of the abuses than scrapping the whole system.

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[HiThere]

That's what patents are supposed to be. That's also what they usually aren't. I don't believe in patents not only because they are generally something obvious, but because they generally do *not* "make patent" the devices that they are claiming a patent on. This may be an exception (though I haven't read the patent, and don't intend to). It is clearly the kind of thing that patents are intended to cover. So if the description does "make patent" the device, i.e. reveal it in sufficient detail that those

Quickest way

[The_Star_Child]

The quickest way to a man's heart is through his catheter.

Anyone else see this and think....

[TheCarp]

"Well, there's a delicate corneal inversion procedure... a multi-opti-pupil-optomy. But, in order to keep from damaging the eye sockets, they've got to go in through the rectum. Ain't no man going to take that route with me! "

Sign me up!

[Eggplant62]

Around Christmastime 2011, I developed paroxysmal non-nodal reentrant supraventricular tachycardia, likely stemming from my maternal grandmother's history of similar cardiac problems, and underwent radiofrequency catheter ablation of the bad conducting circuit in my atrial tissue. I'm left with no fast pacing circuit to increase my heart rate on demand when I'm exercising. I know people with implanted pacer/defibrillators, and I work as medical transcriptionist and have typed a zillion of those procedures, and the things they despise about it is the problems with tissue pocket infections and interval battery replacements, requiring the site to be reopened, the equipment removed and replaced, antibiotic washout, reclosure, etc. I'll be bugging my doc at next visit to research it and determine if I can get one of these.

monkey spunk

[Hognoxious]

surgeons sliced open their patients' shoulders

Shit. Under a local anesthetic?

Re:

[Impy the Impiuos Imp]

They knock you out -- they have to test the automstic defibrillator part and you don't want to be conscious.

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[joseph90]

surgeons sliced open their patients' shoulders

Shit. Under a local anesthetic?

Yup. If you ask they will give you a valium (or equivalent). It does not really hurt.

Re:

[demonlapin]

Usually not, although the description is not entirely accurate - the shoulder joint isn't touched. The device is put just under the skin next to the collar bone.

What if it gets loose?

[Tony Isaac]

If the pacemaker is in the heart, and it somehow got loose (maybe because of an imperfect installation), that could lead very quickly to a dead patient. Maybe they've tested for this, but the article doesn't say.

Re:What if it gets loose?

[jklovanc]

Considering it went through a medical approval process I bet all failure modes have been looked at. Just because an article does not enumerate every test done does not mean that they have not been done.

Re:

[tsotha]

Yep [discovermagazine.com]

Technical correction and comment by a cardiologist

[cecst]

The leadless pacemaker is indeed a real advance, but the summary needs a few corrections, and a comment can be made. I would not want a reader who needs a standard pacemaker to be frightened unnecessarily by the summary as written.
"surgeons sliced open their patients' shoulders and inserted the pulse-generating devices in the flesh near the heart, then attached tiny wires to the heart muscle ... through the femoral artery."

• 1. The incision is made in the skin, not a joint. The implant location is usually the left or right prepectoral region, which is an inch or two lower than the collar bone on the stated side. The pacemaker itself is placed in a "pocket" formed by separating the skin and its attached fat from the underlying muscle. If you have ever eaten chicken, you know that the skin and fat can be separated from muscle. In the uncooked human, of course, separation requires a bit of effort but not much, and a good surgeon will have the area complete numbed up so the patient doesn't feel anything. Thus, the pacemaker is not near the heart: it's outside the rib cage. There are variations on the implant location, but none of them is inside the rib cage.
• 2. The tiny wires (well, pretty tiny) are long, and extend from the area where the pacemaker is through a vein (not an artery, hopefully!) to the heart. The method by which the wires are put in the vein is simple but outside the scope of this post.
• 3. The access is always through a vein (femoral vein, in the case of the new device), not an artery. Blood clots (thrombi, when inside the body) will form on most foreign bodies. From the veins, they can spread only into the lungs, which is relatively safe. From the arteries, even tiny thrombi can cause trouble when they go the brain (strokes), heart (heart attack), gut (ischemic gut), limbs (ischemic arm, leg, etc). Not good.
• 4. The new device can still get infected and still can run out of battery power. What I haven't yet understood is how it can easily be extracted if it gets infected, which is necessary because life-threatening infection can (and usually does) result if an infected foreign body remains in the patient. I guess it's small enough that a new one can be inserted without removing the old one when the battery runs out. There are more technical limitations too that will likely be overcome as the technology improves.

Re:

[demonlapin]

The video clearly shows it's venous access. I don't imagine you're want to be screwing a metal object into an active LV.

Am I the only one?

[JTsyo]

I'm more comfortable thinking about surgery where my shoulders are opened than thinking about something snaking up through my blood vessels from my leg. Though if I was to choose, the benefits would probably overcome my reservations.

Re:

[Neil Boekend]

I had an aneurysm (brain hemorrhage) a couple of years back. I can't remember anything about the operation, but they did such a procedure to install a platinum wire in the ruptured blood vessel. I must say, the alternative (sawing a part of my skull open and having a scar there for the rest of my life) seems way worse. If there had been an alternative, because the center of the brain is difficult if not impossible to operate on from the out side. From the inside it's relatively easy and you don't have to cu

Prolly trough a vein

[Chewbacon]

I wouldn't want something implanted in my arterial system ready to shower clots in me. We don't put pacemaker leads in the arterial system, we put the leads through the venous system. Even a BiV pacer stunning the left ventricle does so through the venous coronary sinus.

Neat Stuff

[batteryman]

Can't wait to start working on this.