Today the cost to own and use endoscope equipment, as well as its ongoing maintenance often makes it challenging economically. There are unnecessary burdens for both office settings and hospital budgets. However, the limitations, for now, provide sensible guidance as to how new endoscope technology should be developed.
This article explores the development of minimally invasive surgical endoscopes that address the cost and durability concerns of both surgeons and hospitals everywhere, working in consultation with surgical experts from Howard University School of Medicine, Ohio Valley Medical Center and Harvard University Medical Center, to bring the latest endoscopic technology to hospitals, outpatient/ambulatory surgery centers, and in-office surgical clinics throughout the world. This includes both a specialized hysteroscope and a ureterscope, currently in development with regulatory clearance.
Hysteroscopy is a procedure where an endoscope known as a hysteroscope is introduced starting at the vaginal opening, passed through the cervix, and into the uterus. Most hysteroscopic procedures are diagnostic. In this case, the hysteroscope with the diagnostic sheath attached, allows for general visual inspection of the cervical canal and uterine cavity in identifying the source for abnormal uterine bleeding, unexplained pelvic pain, or infertility. A 60 cc syringe filled with saline solution (or lactated ringers solution) or an automated fluid pump is connected to the hysteroscope shaft (which has an integrated irrigation channel) to create distention of the highly muscular uterine cavity. High fluid pressure (mean arterial pressure typically 60–80 mmHg) is required. Once inside the uterus, a panoramic view is performed, followed by an inspection of the right and left tubal ostia, which necessitates an angled view (approximately 30°) either by physically manipulating the tip of the hysteroscope towards that targeted area or a rotation of a fixed 30° lens hysteroscope. Upon completion of the inspection of the tubal ostia, the hysteroscope is then gradually withdrawn and again, a panoramic view is performed of the uterine cavity. In total, the diagnostic procedure time is approximately two minutes.
However, there are circumstances where pathology had been previously identified through various imaging or cytology tests or during the diagnostic procedure, where treatment could be completed within the same procedural session. In this case, an operative hysteroscope would now be required where simultaneously, instruments can be introduced and uterine cavity distended through continuous fluid flow to maintain a continuously clear field of view. In an operative procedure, it is typically useful to employ a fluid pump where the procedures can range in length from 10–30 minutes. Instruments include graspers, scissors, biopsy forces, RF (radio frequency) energy hand instruments, injection needles, etc.
Based on our relationship with hundreds of surgeons, we have concluded that surgeons, hospitals and clinics who support them need one vendor when it comes to endoscopes. When it comes to acquiring, maintaining and reprocessing hysteroscopic equipment, for example, in most cases it is very costly and time-consuming. Many of the hysteroscopic setups require the cost of office suite space to position and store the equipment pre-, intra-, and post-operatively. Last, much of the equipment is a mix of interconnected components sourced from more than one vendor, which many times leads to inefficient process behavior in pre-operative preparation, intra-operative execution and post-operative equipment care. We believe surgeons should only have to deal with minimal components.
Trying to manage the purchase, storage, maintenance and repairs of all of this equipment is time-consuming and significantly limits productivity. We are currently researching and developing a hysteroscopic system in which there are few components to connect and that supply the required accessories and disposables, with very little preparation required. We have concluded that they must be intuitive and simplified from the standard design so that the operation of the equipment both enhances procedural efficiency and reduces potential errors and downtime during the procedure—problems that currently add to the overall procedural cost. This requires a minimalist design approach, so that repairs, maintenance and reprocessing are minimized.
In short, we are developing a hysteroscope with the essential technology necessary in performing a both successful diagnostic or therapeutic hysteroscopy. Therefore, valuable time devoted to purchasing and accounting for accessory equipment from multiple vendors will be essentially eliminated.
It would also be helpful to have a digital design that rids the need for a camera head and adapter assembly or add on light table, which has been seen to potentially interfere with scope manipulation.
The global flexible and semi-rigid ureteroscopy market is expected to reach $1.05 billion by 2023. Looking at past use, of the approximately 285,000 ureteroscopies performed in 2013, an estimated 150,000 used a flexible ureteroscope, compared to a semi-rigid design. It was estimated that 12,490 flexible ureteroscopes (both new and repair/exchange units) were sold that year, according to a 2013 Millennium Group Research report.
Kidney stone formation continues to be a growing global problem as eating and drinking habits, as well as overall health, exercising and conditioning deteriorates. There are two primary ways in treating kidney stones lodged in the kidneys and ureters: ESWL (extracorporeal shockwave lithotripsy) and retrograde flexible ureteroscopy (with laser fiber lithotripsy). Over the past few years, numerous studies have concluded that flexible ureteroscopy is a superior approach to achieving stone-free rates than ESWL.
Flexible ureteroscopy is performed in OR and ASC/outpatient settings. An operative cystoscope with inflow fluid (saline) flowing through the irrigation channel of the scope is introduced through the urethra and into the bladder. A metal or nitinol guide wire is then threaded through the working channel of the cystoscope and then advanced through the ureteral orifice and finally navigated up the ureter into the kidney. The placement of the guidewire is performed under intermittent fluoroscopy. Once the guidewire is placed, the operative cystoscope is removed and replaced by a flexible ureteroscope that is advanced (with inflow fluid running through the irrigation/working channel) over the guidewire (through the irrigation/working channel of the scope) and the scope tip is positioned just in front of the kidney stone. During this step, the surgeon is watching the positioning of the scope via a monitor. In addition, scope tip placement is confirmed through intermittent fluoroscopic imaging. The next step is to introduce a laser fiber, position the tip of the laser fiber in close approximation of the stone, and begin the lithotripsy procedure in breaking the stone into minute fragments that can then be easily passed during urination.
Current flexible ureteroscopes have a diameter of <9.5 Fr., are approximately 650 mm in working length, and have two-way active tip deflection of upwards of 275° in each direction (up/down). Until recently, all ureteroscopes were designed with a flexible optic image bundle, but newer designed scopes providing much better imaging incorporate a digital chip sensor supplanting the optic image bundle for the scope.
The primary usage of a flexible ureteroscope is for identifying and treating kidney stones located in the kidney or ureter. And the treatment typically involves using a laser fiber (powered by holmium laser energy) to breakup (into small, particle-sized fragments) or “dust” kidney stones. Due to the small scope diameter, long length, constant tip deflection, frequent torqueing of the scope’s shaft, and repeated laser fiber usage, these scopes break down anywhere from 3 to 30 uses—and that gets expensive. In addition, teaching/academic healthcare institutions typically experience a higher rate of damage since these are centers where teaching younger physicians is most prevalent.
There are many ways damage of the scopes can occur:
- Mishandling of the scope during the procedure
- Excessive tip deflection or torsion of the shaft
- Inadvertent introduction and puncturing of the scope’s working channel with a laser fiber while the scope tip is deflected
- Inadvertent fibring of the laser fiber while the tip of the laser fiber is retracted in the scope’s channel
- Laser fiber fatigue leading to a fiber breakage within the scope’s channel and subsequent puncturing of a hole in the scope’s channel due to stray energy
- Inappropriate hand instrument introduction into the working channel
- Mishandling during transportation, cleaning and/or reprocessing
Building a scope to withstand these commonly occurring problems over many uses is a significant challenge given the anatomy space constraints, scope functionality and size requirements, and the high purchase and repair costs. Our research has led us to develop a scope that maintains and enhances the functionality while minimizing scope downtime due to scope damage. We believe the solution consists of a flexible digital ureteroscope with a reusable control handle and a disposable shaft. Right now what you have are scopes that require an in-depth surgical reprocessing protocol that is time-consuming and potentially damaging to the scope.
Competitive flexible digital ureteroscopes are very costly to purchase (approximately $18,000) and extremely expensive to repair (approximately $7,500). It is widely known that one may only get 3–30 uses from a reusable flexible ureteroscope before a major repair is required, and it is not uncommon for a scope to be repaired 3–4 times in any one year. This issue does not take into account the cost of backup scopes needed for support, the downtime to prepare another scope, and the subsequent logistics and time to process a repair. It is conceivable that a single flexible ureteroscope may cost the hospital or outpatient facility approximately $30,000 in repairs alone (within one year), plus the additional costs that were stated above, nothwithstanding maintenance and reprocessing, plus the initial cost of the purchase of the new scope and most likely an additional purchase of at least one backup scope. All told, the total cost can be much less, saving our nation’s doctors, hospitals and patients significant revenue.
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