Timothy McKinney, MD

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“I’m  Harry Reich, Vice-President of the ISGE and we’re at the 12th annual meeting  of the ISGE. At this moment  I’m getting the chance to talk with Tim  McKinney, who is one of the leaders in laparoscopic pelvic support and other  pelvic support and urogynecological operations. So Tim, tell me about this new  procedure, the IVS Tunneller.”
  
  

 “Well, thanks for  having me here to talk about this, it’s pretty exciting actually, something  new that we’re able to add to the armamentarium of vaginal support. It’s  still rather novel in the States. There have only been about 100, maybe 100  plus, procedures done in the States; however, this is not a new procedure over  in Europe.”
  
  

 “What condition would  you use this for?”
  
  

 “It’s basically used  for any kind of significant apical prolapse of the vagina, high rectoceles and  enteroceles; it adds a little extra support in the posterior wall and it’s  kind of mimicking the TVT for the posterior wall.”
  
  

 “A simplified way in  which to do a vault suspension.”
  
  

 “So this would take the  place of a sacrocolpopexy -type procedure or not quite?”
  
  

 “It’s supposed to be  mimicking and handling where a sacrocolpopexy or sacrospinous fixation would  do, only it doesn’t get quite the apical support that those two procedures  would give, but gives a satisfactory result for those patients with some apical  support but with an enterocele or rectocele.”
  
  

 “I think the big  question here is, is it easy to do? Do you think most gynecologists would be  able to incorporate this into their surgical armamentarium?”
  
  

“Well, I tell you,  Harry, I was really nervous when I began with the procedure. I ended up having  to be convinced of the anatomy and where we were placing this was a safe  procedure and started doing it first on cadavers just to make sure for myself  and understand where we were passing these little tunnellers and we’re  actually coming about two centimetres lateral to the anal sphincter area at  about the 4 o’clock and 8 o’clock positions, we’re moving through the  pararectal fat space and coming up parallel to the iliococcygeus muscle and  then coming out just at or above, above meaning anterior, to the ischial spine. 

In looking at the anatomy there, we are avoiding most of the blood supply that we would be worried about where this thing is going. At the ischial spine, we have to worry that one centimetre below and lateral to the ischial spine, we have the pudendal nerve, artery, and vein. We’re above that by at least a centimetre.”
 
 

 “So like you said, this is a posterior TVT where instead of checking the bladder at the end, you check the rectum during the procedure and at the end.”
 
 

 “Now, let’s go back to the beginning. How do you work up a patient who has this potential problem?”
 
 

 “Essentially, the patient would come into the office, you do your usual physical exam, identify any of the defects that are going on, whether they are anterior compartment defects, posterior compartment defects, you do your entire procedure to identify where each of the hernias of the pelvic floor are and then at that point, we end up trying then to identify what we need to end up as our outcomes. 

What we’re trying to end up doing is mimicking what our results would be afterwards, so we have to look for occult problems that may develop after we repair the prolapse. The biggest one that I worry about is changing somebody’s quality of life by creating a severe incontinent problem post-operative. When you take the kinking out of all the tissue from the hernia, bring it all back to its own position, you can leak like crazy, and it would drop their quality of life substantially.”
 
 

 “So for many of these people, you would have to do some anterior work, also.”
 
 

 “You do anterior work at the same exact time. You also want to think about doing some form of diagnostic work-up, including urodynamics procedures, to be able to identify those patients with an incontinent problem, also urge and frequency. Peter Petros, who had brought this procedure into existence, has shown some promising data that there is actually a decrease in some of the urge and frequency that has developed in these. If you have ever worked in incontinence, when you work on the posterior wall, it affects the anterior functionality, as well.”
 
 

 “I see you have a little catheter here. What is that all about?”
 
 

 “Harry, I ended up through the years of doing urodynamics being rather frustrated with the technology that was out there and I was trying to come up with something that was a lot easier to use, that would enable the average physician that was out there who maybe doesn’t do ten to fifteen of these a week, maybe does a couple of these a month, to be able to have a plug and play technology. 

I also wanted to have the most accurate type of a diagnostic tool for their hands and so I came up with a diagnostic tool: it’s the first urodynamic pressure catheter and is called a T-Doc Air Charged Catheter. It has a circumferential balloon that allows for pressure to be measured as an average pressure throughout the entire environment. This one in particular has two sensors, one that goes into the bladder, and one that stays in the urethra. We also carry one that will measure pressures in the rectal region. It’s plug and play. These hook into your standard urodynamic equipment, which can cost as little as $6,000 to $7,000 to get a system that can do all the functionality that you need to get the billing into your office.”
 
 

 “So this would be an office procedure?”
 
 

 “It takes about twenty minutes to a half an hour for the procedure. The beauty of it is reimbursements in the States are increasing on a yearly basis. One of the few rare things that is.”
 
 

 “It’s got to be one of the only procedures where that’s possible.”
 
 

 “It’s true because the government really wants to drive people to start doing work-ups for pelvic floor prolapse and incontinence because it is such a major epidemic problem. By the year 2030, there’s going to be 40 million patients with some form of prolapse which, right now, the statistics are 11% are needing operations. 11% means that you have 9 million operations, between re-operations and operations.”
 
 

 “We know there are all these problems with urinary stress and continence, but what about vault prolapse and the posterior wall? Is that also as common?”
 
 

 “That is the thing that we’re talking about, Harry. This is endemic for having larger babies delivering vaginally, we’re having people who aren’t tolerating living through life with everything hanging out, with quality of life going down the tubes, not having the sexual functionality that they’d like to have, so they’re addressing the problem more and more. This IVS Tunneller™ allows us a 15 to 20 minute procedure to augment the anterior or the posterior wall. You do have to repair all the other defects associated with the pelvic floor at the same time, but it gives you an anchoring point which is rather substantial so that it is not going to fall down past that.”
 
 

 “So if you have the TVT and this other procedure in your surgical armamentarium, you have a patient who needs work in both situations, approximately how long would that operation take, doing the anterior area and the posterior?”
 
 

 “If you were at specific sites that were taken care of and addressed just by the IVS Tunneller™ and then the TVT aspect, which this can actually be plugged in or a lot of people are using the same instrumentation for doing the TVT side of things, it would take under an hour to do the entire procedure. The easier part of the IVS system is that you can actually palpate the entire length of where this tunneller is going, so you can place your fingers in vaginally and you can march it right up to your finger at the ischial spine and pass it out and that is the positive aspect of it.”
 
 

 “Nice. Is there anything else that you would like your audience to know about both of these situations?”
 
 

 “Well, I think as far as the catheter situation and prolapse and incontinence, it shouldn’t just be a fact of whether or not you are going to incorporate these things into your practice. It’s how much you want them to be a part of your practice because with that many cases being out there, you have to be taking care of them and you better get it into your head that you want to do this in the most appropriate fashion. So work them up thoroughly and get hold of a urodynamics system. The reimbursements from Medicare alone are close to $800 per procedure. I get paid, in some instances, over $1,000 just for the urodynamics. But with the machinery out there under $7,000, it pays for itself quickly. A disposable catheter system like this makes it a plug and play situation, makes it easily incorporated into your practice, hook it up, toggle it, flip the switch forward and you’re measuring pressures. It’s as simple as that, no hanging of IV fluids and getting air bubbles out or microchips and antiseptics to end up sterilizing your equipment. So you can add this to your office armamentarium. It’s easy to learn, it’s not as complex as you may think and does get reimbursed at a very good rate and you can do a wonderful job for your patients at the same time in improving their quality of life.”
 
 

“It sounds like this is one of the directions many gynecologists listening in should be very interested in learning more about in the future, so thank you very, very much, Tim, for all that information.”
 
 

Articles

OBGYN.net Conference CoverageFrom the XII Annual Meeting of the International Association of Gynecological Endoscopists (ISGE)

Urodynamics and the IVS Tunneller™

  “Next to me is Professor Timothy McKinney who  is the Chief of Urogynecology at the University of New Jersey.   Professor McKinney, I understand you’re here to present the paper about a  special urethral catheter, what’s so special about this catheter?”
       
       

   “Basically, what we’re talking about is a technology for investigating  and understanding the pathophysiology behind incontinence and pelvic  floor dysfunction, and it’s called urodynamics.  In the process of  evaluating these patients for incontinence, we require certain catheters  to be able to monitor the pressures.  In the past there have really  been three main technical groups and potentially a fourth in which the  pressure transmission from the bladder and urethra are monitored.  Those  catheters that have been standardized out there were the microtip  transducers, the water-filled catheter type of technology, which has an  external transducer, as well as a fiberoptic technology.  There was a  fourth in there as far as water balloon technology with a transducer  down at the end.  Our problem with a lot of the present day standard  catheters that are out there are that they were point sensors, they  looked in one single direction.  That was fine and normal and easy to  use within large environments such as within the bladder.  However, when  you get in compliant spaces like the urethra, you are looking in one  point direction and can show variation in those catheters.”
       
       

   “So you were looking for a catheter used to measure the intrauterine  pressure and fetal monitoring yet they were too big for using in the  urethra.”
       
       

   “What you’re elucidating to is how do we come up with the technology for  this.  There’s a company called Clinical Innovations that made an  intrauterine pressure monitor system called the Koala.  This  intrauterine pressure monitor used air charged balloon technology and  between that technology and our resources from T-doc, we designed an  intrauterine pressure catheter to use for urodynamics.  We had to change  all the technologies and change all the patent ability around how this  worked, but we were able to bring it down to a 4-French technology as  well as down to as low as a 4-French to be able to do urodynamic  monitoring.  We wanted to make sure that we covered a full realm of  needs for urology as well as gynecology for the evaluation of the  incontinent patients so we needed to have the whole family of catheters.   Right at present, we have a dual sensor catheter for measuring both  intrauterine pressure, as well as intraurethral pressure, and filling  the bladder at the same time.  We have a single sensor with filling, we  have an abdominal pressure catheter, which is a single pressure  transducer, we have a 4-French, and we have radiopaque catheters.  The  beauty of this is that it’s a plug-and-play type of a catheter.  It’s  very easy to use, it is a disposable product so it rapidly turns over,  and you don’t have the problem of contamination that’s going on.”
       
       

  “You’re advertising your catheter at this moment very well but what are the figures on which you base your enthusiasm?”
       
       

   “My enthusiasm is based on the fact that we needed to evaluate urethra  pressures a little bit more carefully.  My fellow Sam Hessami and myself  just picked up the Urogynecology Award for Urogynecology from the  American College of Obstetrics and Gynecology this year.  We’re looking  at an objective index for the severity for incontinence and the object  data required a more specific intraurethral catheter for measuring  pressures.  The present day technology, as I can show you in a cadaveric  data on reproducibility of urethra pressures, was far from acceptable  for any kind of standardization.  We basically ran through with the  urodynamic different technologies on a set pressure system on a  cadaveric model.  Basically, we were looking at the reproducibility of  the data.  We found that for the water transmission catheters, we had a  standard deviation of approximately 15, which is demonstrated here.  For  the fiberoptics, we were at a pressure transmission standard deviation  that was about 13 ranging all the way from a number of intrauterine for  pressure which would register as something normal which was up at 42,  and normal being anything above 20 mm of water pressure all the way down  to zero pressure depending upon where that single sensor was ending up  directed.  The microtips were off by about a factor of 9-10, whereas we  ended up working with a circumferential catheter which was able to then  measure data points from all around in an average point and an area  point within the urethra, and we were able to get a reproducibility of 1  standard deviation from this catheter.  What that has enabled me to do  is be able to see some of the pathophysiology going on during the  process of urodynamic evaluation without having to have fancy video  urodynamics to actually see the urethra maybe giving out.  We’re  actually able to see some changes, and subtle changes in the urethra  that may revolutionize how we’re able to evaluate the incontinent  patient.  So it’s pretty exciting and this is what I based my excitement  over besides it being easy to use, its reproducibility and its  standardized aspect, and its ability to be dead on one time after  another for pressures.”
       
       

  “It’s almost so convincing that you tend to not believe it because it’s so small this…”
       
       

   “That standard deviation, correct.  It’s an exciting aspect, I think the  technology or the idea for the technology has been out there.  There  were balloon water transmission type of balloon catheters that measured  area and circumferential aspects, and they were known to be better at  detecting some of the urethra pressures.  But still a little bit more  difficult to use, and there were changes and drifting of it because with  the water transmission, the fact that the water heats up and as it  enters into the body there is changes that way.  There is also  gravitational pull so there is change in the pressure from the anterior  wall of the balloon to the posterior wall of the balloon giving it some  deviations that way.  Whereas with air, there was no change in the  pressures that way so from that standpoint this was an easier setup,  easier to use, and a simpler system with just air being utilized in the  catheter.  This is one study that I’m presenting at IUGA - the  International Urogynecology Society meeting in Rome, we’re also…”
       
       

   “In October around the 25th is when I think this paper is being  presented.  I’m reproducing the data from Dr. Harry Johnson’s  laboratory.  We’re doing another totally separate running of this just  to re-document and re-verify and get a little bit more technical with  the comparison study as well as an IRB study on human patients.  At this  point, I’d like to at least show you the catheter.”
       
       

  “Yes, of course, we can do that.”
       
       

   “Basically, this is one of the catheters.  It comes in just a little  sterile packet and essentially this opens up with the catheter coming  out.  This one’s been through the mill, however, it is color coordinated  for ease of use.  We have one, which will be the intraurethral pressure  and the other, which will be the intra-vesicle pressure, and they line  up to the cable that ends up coming into the computer for the  urodynamics machine.  The actual catheter ends up hooking in with a  laurel lock exchange, which just locks into place, and matching the  colors makes it pretty simple so that you can’t mess up.  We have a  little filling channel so that we can fill the bladder.  We end up  placing the catheter into the bladder.  At that point, we zero out the  machine for the pressures and then once we’re zeroed out, we just charge  the balloon so we end up pushing the lever forward which puts a  specific amount of air-gas that travels down to the little sensor and  blows up the balloon just enough to separate it off the catheter,  thereby creating a seal that transmits the exact pressure from up here  back into the microtransducer and back into the computer.  We have a  dual sensor so we can have both bladder and urethra pressures going at  once; so you can see instability within the urethra, and you can see  which gives out first.  I’ve had numerous patients that had what I  thought was just a straight out bladder instability or an overactive  bladder that it turned out it was a urethral instability.  The urethra  actually gave out before the bladder contraction began and it’s a  totally different pathophysiology that’s going on and treated totally  differently.  So seeing data like that is exciting and makes some  difference, I think.”
       
       

  “You can see it while you have two balloons at the same time?”
       
       

   “Right, basically, you have your computer screen and you can actually  see the pressures for the vesicle pressure lined up right on top of the  urethra pressure, right on top of the abdominal pressure.  Then you can  see the subtraction of the abdominal from the vesicle and the true  pressure so with that you’re able to see all kinds of variations.  I’ve  seen sinusoidal patterns within the urethra with this instability  finally ending up with you seeing the pressure start dropping below the  inter-vesicle pressure within a spike upwards of the bladder pressure  then giving the true instability and incontinence but really it was an  urethral problem that occurred and caused the whole problem.  So from  this standpoint, it’s simple; you take and you throw it away, throw it  in the garbage, hook up another one, and you’re ready to go for another  procedure if you need to.  From a standpoint of my research, it was  totally necessary that I had to have this to be able to proceed with any  kind of objective reproducible index for the severity for incontinence.   Hopefully you’ll start seeing that data coming out or at least the  pilot study will be done this year, and that’s what we got the grant  money from ACOG for.”
       
       

  “We’re looking forward to the results of that study.  Thank you very much.”
       
       

OBGYN.net Conference CoverageFrom FIGO Washington D.C., USA - September 2000

Timothy McKinney, MD

Articles

Urodynamics and the IVS Tunneller™

Urogynecology - New Catheters