Scar tissue – a (im)possible complication?
The spermatic duct consists of living tissue. Tissue grows, heals and forms scars after injuries. What happens with the Bimek SLV? Do the spermatic duct and valve grow together with time? Let’s find out:
Please note; a man’s spermatic duct consists of 2 elongated muscles, between these lies a traversing muscle. The spermatic duct is not “dead tissue”, but a living part of the body.
Often you’ll observe a phenomenon with implant surgeries; within the year after the implant the surrounding tissue grows together with the implanted object. The tissue damaged by the implant surgery heals and binds together with the foreign object during the healing process, forming a fixed scar tissue.
Can this also be expected from the Bimek SLV? Yes.
Will it impair the function of the valve? No.
Is it dangerous for the wearer? No.
Does it damage the valve? No.
Searching for the right size
In retrospect – in the year 2004 Clemens Bimek began searching for medical technology companies. His research lead him to MEDICA Düsseldorf, where the who’s who of medical technology gather. Aside from numerous manufacturers, like the ones he was looking for, he also saw gruesome videos from the OR. For some it’s hard to believe just how brutal surgeons handle vessels and organs during a heart valve implant surgery.
And that’s supposed to work? When it’s so brutal? Then there’s the problem with implant rejection and scarring with the danger of a blocked artery. Apparently, it’s not an issue…. Otherwise a ¼ million stents wouldn’t be implanted in Germany every year. Right?
Every beginning is hard – but that just makes every product even better
Clemens Bimek had implanted 3 different prototypes of his valve throughout its development period. Of course the explanted pieces at the time did not find their way into the waste, instead they travelled under the microscope. And – yes – the first valves resulted in scarring in the area around the connecting tubes, as these weren’t yet available in different sizes. Connectors that were too big had caused tissue damage, which lead to scar tissue.
However the scarring did not cause a blockage of the opening for passing sperm cells.
The SLV 4.0
To this day Clemens Bimek wears the SLV 3.0. Participants taking part in the clinical trials will be dealing with the SLV 4.0, a further developed model. The 4th generation has connectors in different sizes, from XS to XL. Each of the 5 inner and outer sizes allow for 25 different size combinations – and the right size for all 4 spermatic duct ends.
This plays an important role if the SLV is being implanted in someone who has already had a vasectomy. During a vasectomy the spermatic ducts are firmly sealed, which leads to a congestion of sperm cells and widening of vessels on the end coming from the testicles. This means each end of the spermatic duct is a different size. This presents no problem for the SLV. The valve entrance is simply fitted with an XL connector and the exit with an XS.
With a “normal” implantation of the SLV, the spermatic ducts are kept intact up to the last millimeter. Thanks to the new connectors the tissue is so slightly affected and the spermatic ducts burdened so slightly that the scar tissue remains minimal, preventing a case of sperm cells overrunning the duct. It really couldn’t be less traumatic.
The Worst Case Scenario
Of course we’re also prepared if the worst case scenario should occur. So what happens if the passageways actually become clogged? If this should happen, the ducts would be cleared during an outpatient surgery using specially manufactured tools, without having the valve removed or dismantled.
We definitely do not expect this to happen, though we’re still prepared for it, if it does.