device to assist ultrasound for neuraxial

[stephenpatrickd]

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Hello all,

I'm working on a device to assist with real-time ultrasound for neuraxial procedures.

Pls take a look if you have time.

biplanemedical.com

Would you try it?

I'm looking for a collaborator to do a noninvasive clinical trial, if you are interested pls reach out.

Any feedback appreciated.

Thanks!

 

[abolt18]

Real life? Haven't found a need for ultrasound for neuraxial... Used it a handful of times in residency with limited benefit.

 

[deleted87051]

How would you maintain sterility while using that device?

 

[Guillemot]

Curvilinear for finding midline in super obese can be helpful.

Otherwise there is a device called Accuro that supposedly does what you are proposing to do. My first job out of residency had it, but the only one who used it was an older anesthesiologist. He iked it, but he was pretty terrible all around. So hard to say if the device was good or if it just helped him put in epidurals that most people would not find technically challenging.

 

[stephenpatrickd]

Real life? Haven't found a need for ultrasound for neuraxial... Used it a handful of times in residency with limited benefit.

Thanks for your comment.

I agree that getting the catheter in isn't a problem for experienced providers.

I am imagining two advantages to motivate the hassle of an extra device.

1. One stick. Real-time ultrasound could turn a multi-stick procedure into a one-stick procedure, as it did for central lines. This could matter to certain patients.

2. Lower epidural failure rate when going from labor to c-section. This article cites a failure rate of about 10%. I would expect that going from centimeter precision to millimeter precision with respect to midline entry of epidural space would make a difference.

Bauer, M. E., et al. "Risk factors for failed conversion of labor epidural analgesia to cesarean delivery anesthesia: a systematic review and meta-analysis of observational trials." International journal of obstetric anesthesia 21.4 (2012): 294-309.

Thoughts welcome!

 

[stephenpatrickd]

How would you maintain sterility while using that device?

It would be sterile single use, like the other plastic needle guides that are on the market. It would have an integrated sterile sleeve to cover the probe and the probe cord.

 

[stephenpatrickd]

Curvilinear for finding midline in super obese can be helpful.

Otherwise there is a device called Accuro that supposedly does what you are proposing to do. My first job out of residency had it, but the only one who used it was an older anesthesiologist. He iked it, but he was pretty terrible all around. So hard to say if the device was good or if it just helped him put in epidurals that most people would not find technically challenging.

Thanks for your comment.

I've used the accuro and found it to be no better than the traditional curvilinear for prescan (non-realtime).

 

[UscGhost]

Real life? Haven't found a need for ultrasound for neuraxial... Used it a handful of times in residency with limited benefit.

Its one of those things that will slowly become more common.

I never did an art line with ultrasound until private practice. Do i NEED one? No. But of you are fast and efficient at using it, then it becomes a faster and more reliable way to place one

 

[deleted87051]

It would be sterile single use, like the other plastic needle guides that are on the market. It would have an integrated sterile sleeve to cover the probe and the probe cord.

How would workflow go?

Pre-scan, glove up, prep skin, attach/adhere device to skin, probe cover, scan, then needle insertion? No additional drape?

 

[stephenpatrickd]

How would workflow go?

Pre-scan, glove up, prep skin, attach/adhere device to skin, probe cover, scan, then needle insertion? No additional drape?

I don't envision a drape, just the usual sterile sheet on the bed behind the patient,

1. pre-scan with non-sterile curvilinear probe, axial to get midline, parasagittal to count from sacrum to identify L3-L4, make mental note of entry site on skin.

2. prep back widely, glove up, place sterile sheet on bed behind patient

3. open sterile container with biplane device, drop probe in, extend sterile sleeve

4. affix biplane device to patient's back

5. perform targeting as shown in the video at biplanemedical.com, advance needle


I do step 1. for all my patients currently, it takes about a minute. I would expect the other extra steps would add about 5 mins, but the net may be overall time saving if it enables one needle pass instead of the usual ~5 mins of redirecting with larger patients.

Thoughts/comments much appreciated.

 

[UscGhost]

I don't envision a drape, just the usual sterile sheet on the bed behind the patient,

1. pre-scan with non-sterile curvilinear probe, axial to get midline, parasagittal to count from sacrum to identify L3-L4, make mental note of entry site on skin.

2. prep back widely, glove up, place sterile sheet on bed behind patient

3. open sterile container with biplane device, drop probe in, extend sterile sleeve

4. affix biplane device to patient's back

5. perform targeting as shown in the video at biplanemedical.com, advance needle


I do step 1. for all my patients currently, it takes about a minute. I would expect the other extra steps would add about 5 mins, but the net may be overall time saving if it enables one needle pass instead of the usual ~5 mins of redirecting with larger patients.

Thoughts/comments much appreciated.

I think larger patients it would be useful.

For thin patients with reasonable landmarks.. probably not worth the trouble

 

[deleted87051]

I don't envision a drape, just the usual sterile sheet on the bed behind the patient,

1. pre-scan with non-sterile curvilinear probe, axial to get midline, parasagittal to count from sacrum to identify L3-L4, make mental note of entry site on skin.

2. prep back widely, glove up, place sterile sheet on bed behind patient

3. open sterile container with biplane device, drop probe in, extend sterile sleeve

4. affix biplane device to patient's back

5. perform targeting as shown in the video at biplanemedical.com, advance needle


I do step 1. for all my patients currently, it takes about a minute. I would expect the other extra steps would add about 5 mins, but the net may be overall time saving if it enables one needle pass instead of the usual ~5 mins of redirecting with larger patients.

Thoughts/comments much appreciated.

Does the biplane device have allowance to change interspaces? Since it is fixed to the back, it seems like it would be unwieldy if that becomes necessary. So the initial prescan becomes very important.

 

[stephenpatrickd]

Does the biplane device have allowance to change interspaces? Since it is fixed to the back, it seems like it would be unwieldy if that becomes necessary. So the initial prescan becomes very important.

Good question.

The biplane device could be made large enough in the vertical direction to allow translation between interspaces, with the drawback that the device is a bit bigger.

For young patients without osteophytes etc, I would expect that real-time visualization of the bones and the ligament would prevent the need to move to another space. So I expect that the ability to move to another space won't be worth the extra size. But this would have to be worked out in real usage.

 

[stephenpatrickd]

I think larger patients it would be useful.

For thin patients with reasonable landmarks.. probably not worth the trouble

I agree. My guess is the threshold for it being worth the real-time will be around a ligament depth of about 6cm (or bmi ~35 according to the paper below).

I do believe that all patients deserve a prescan however, since even thin people can have scoliosis.

Clinkscales, C. P., et al. "An observational study of the relationship between lumbar epidural space depth and body mass index in Michigan parturients." International journal of obstetric anesthesia 16.4 (2007): 323-327.

 

[DocVapor]

How much needle length are you losing to use this? Am I breaking out the harpoon every time? That also begs the question - on the obese patients where this *could* be helpful - i.e. the needle is tenting into the skin - would we even be able to reach?

Not to mention - is the needle guide at a locked angle? If the angle is set to reach the target at 4 cm - how do you adjust the needle angle when the expected loss is at 10cm so you don't overshoot and end up off to the side?

How do you keep these patients still enough that this device won't actually get in the way or even just straight up fall off?

I don't mean to be harsh but I'm just trying to visualize how I could use this when after I spend time getting all these fiddly adjustments set only for the patient to have a contraction or sneeze and have everything get thrown off.

 

[linkin06]

I feel like the challenge in fluffy patients is finding midline, which can be identified by any basic ultrasound. No need for a separate device

 

[stephenpatrickd]

How much needle length are you losing to use this? Am I breaking out the harpoon every time? That also begs the question - on the obese patients where this *could* be helpful - i.e. the needle is tenting into the skin - would we even be able to reach?

Not to mention - is the needle guide at a locked angle? If the angle is set to reach the target at 4 cm - how do you adjust the needle angle when the expected loss is at 10cm so you don't overshoot and end up off to the side?

How do you keep these patients still enough that this device won't actually get in the way or even just straight up fall off?

I don't mean to be harsh but I'm just trying to visualize how I could use this when after I spend time getting all these fiddly adjustments set only for the patient to have a contraction or sneeze and have everything get thrown off.

These are all valid concerns.

The needle guide would require at least 2cm extra needle length, so the big patients with 10cm loss would definitely require the 15cm needle if not longer.

Yes, the needle guide is at a locked angle, but it is quite parallel to the probe. The idea is that you make a specific lateral adjustment based on the ligament depth to ensure the needle path crosses the ligament at midline.

Keeping the patient still for the requisite time may be an issue. Typically, when I am engaged with the ligament I ask the patient to be very still since I know I'll be done in a minute or two. I think the measurement and adjustment with the biplane could be under a minute, even down to 5 or 10 seconds, so I don't think asking them to be still for that time is a dealbreaker. Eventually, this could be automated with machine vision and servo actuators and be even faster.

The feedback is much appreciated!

 

[stephenpatrickd]

I feel like the challenge in fluffy patients is finding midline, which can be identified by any basic ultrasound. No need for a separate device

Thanks for your comment.

It seems a shame to have the ultrasound at the procedure and not have the gold-standard care (real-time guidance).

 

[abolt18]

Thanks for your comment.

It seems a shame to have the ultrasound at the procedure and not have the gold-standard care (real-time guidance).

Just because you call it the gold standard, does not make it so...

 

[Aether2000]

It could be useful as a teaching tool in university programs. I use a paramedian approach for both epidural blocks/catheters and SAB so it would not be helpful to me personally, but I also do one stick subclavian vein catheter placement without ultrasound preferentially over IJ placement.

 

[stephenpatrickd]

Just because you call it the gold standard, does not make it so...

I was hoping no one would spot that loophole.

 

[stephenpatrickd]

It could be useful as a teaching tool in university programs. I use a paramedian approach for both epidural blocks/catheters and SAB so it would not be helpful to me personally, but I also do one stick subclavian vein catheter placement without ultrasound preferentially over IJ placement.

Thanks for the comment.

The device actually is designed to guide the needle in a paramedian approach (approx 15 degrees tilt to the left and 15 degrees cephalad). I chose this approach (over midline) since it seems to offer the largest window and thus the least chance of hitting os.

 

[coffeebythelake]

I find the most difficult part of doing neuraxial in morbid obese patients is marking midline when everythjng feels fluffy and no landmarks are palpable. I have a handheld ultrasound that I use. Takes me 10 seconds to scan and mark spinous processes. Then it's all just a matter of 1 axis of redirection. No need to do a full ultrasound evaluation for neuraxial. Just transverse

 

[buddababa]

Hello all,

I'm working on a device to assist with real-time ultrasound for neuraxial procedures.

Pls take a look if you have time.

biplanemedical.com

Would you try it?

I'm looking for a collaborator to do a noninvasive clinical trial, if you are interested pls reach out.

Any feedback appreciated.

Thanks!

nice idea, would slow me down too much for me to even consider it, maybe good for training programs

 

[pgg]

If the geometry of this thing could be adapted for paramedian approaches for thoracic epidurals, I think it might be useful for those, particularly in low-volume places, where even experienced anesthesiologists tend to be a bit rusty.

The difficult OB epidurals are always all about obesity. The difficult thoracic epidurals are usually all about anatomy and getting the right insertion point and angle to slip. I routinely use the local anesthetic needle as a finder to probe bony landmarks. Ultrasound might be better.

Compared to OB, you can count on a lot less patient movement. And a lot more patience from the patient. 🙂

I don't see much upside to ultrasound, beyond perhaps a scouting scan, in OB. And I'm a believer and advocate for ultrasound elsewhere - I think people who don't use ultrasound for their first stick, every time, when doing art lines, are dinosaurs.

It is quite OFTEN that I will decide the radial artery is too torturous, calcified, or small to even bother sticking once, and move immediately to the other side or brachial. Ultrasound is never going to give me a reason to look for another spine though.

Ultimately I think this thing is too bulky and convoluted and dial/setting-heavy to get routine use.

 

[Drwine]

If the geometry of this thing could be adapted for paramedian approaches for thoracic epidurals, I think it might be useful for those, particularly in low-volume places, where even experienced anesthesiologists tend to be a bit rusty.

The difficult OB epidurals are always all about obesity. The difficult thoracic epidurals are usually all about anatomy and getting the right insertion point and angle to slip. I routinely use the local anesthetic needle as a finder to probe bony landmarks. Ultrasound might be better.

Compared to OB, you can count on a lot less patient movement. And a lot more patience from the patient. 🙂

I don't see much upside to ultrasound, beyond perhaps a scouting scan, in OB. And I'm a believer and advocate for ultrasound elsewhere - I think people who don't use ultrasound for their first stick, every time, when doing art lines, are dinosaurs.

It is quite OFTEN that I will decide the radial artery is too torturous, calcified, or small to even bother sticking ones, and move immediately to the other side or brachial. Ultrasound is never going to give me a reason to look for another spine though.

Ultimately I think this thing is too bulky and convoluted and dial/setting-heavy to get routine use.

I agree with you. When doing epidurals, I joke that my probing for bony landmarks with my local needle is my poor man's ultrasound device. 😉

 

[Maverikk]

@stephenpatrickd I appreciate your work. Anesthesia is not like ortho where having new equipment can change outcomes. Yes ultrasound for blocks/lines was the last the big change. What I would say is does the technology change the workflow, most of my spinals/epidurals are less than 10 minutes, yes redirection happens. In my first year out I had one where I called for help, another partner hubbed the harpoon to get it and it worked great, that dude I learned from. Although I will say if you can prove your device works 99% of the time it may sell to a lot of smaller hospitals who want assurance and are willing to invest, other than that it’s hard to think of a day-to-day application. That being said it is nice work, it may improve people’s use of ultrasound on OB which tbh I need to get better at

 

[ranvier]

Spinal Navigation Technology - Rivanna Medical

Clinical evidence collected from around the world enlisting more than 600 subjects

rivannamedical.com

 

[coffeebythelake]

I agree with you. When doing epidurals, I joke that my probing for bony landmarks with my local needle is my poor man's ultrasound device. 😉

Hard to do on a bmi 50 whale. Needle doesn't reach that far

 

[coffeebythelake]

Spinal Navigation Technology - Rivanna Medical

Clinical evidence collected from around the world enlisting more than 600 subjects

rivannamedical.com

I've have a rivanna and i prefer my ge vscan. Less gimmicky better quality.

 

[pgg]

Hard to do on a bmi 50 whale. Needle doesn't reach that far

LAW #6

There is no body cavity that cannot be reached with a #14G needle and a good strong arm.



17g Tuohy "finder" will get there too. 🙂