Zachary Taub

My team and I started our Clinical Immersion experience in the Urology department. We spent each day rotating between clinic and the OR, watching how clinical procedures may escalate to surgery, and how various diagnoses may be uncovered, from nephrolithiasis to incontinence. The mode of visualization and screening primarily used both in OR and clinic was a cystoscope. The camera was used to visualize components of the urethra, the neck of the bladder near which the prostate sat (in men), and the bladder itself.

Based on the procedures and patients I saw, I noted that a form of good engineering used by the urology department involved the use of the use of the cystoscope to inject liquid into the bladder to test for additional incontinence and determine where the source of the leak occurs. The cystoscope has a small stream of water from the tip that allows it to be smoothly guided into the urethra, to swell the bladder to be able to fully examine the site, and to test for the primary source of dysfunction that induces leakage. For instance, whether incontinence can be prevented by striated muscle or if “holding your bladder” does not suffice.

A component of bad engineering I observed was the limitation of the cystoscope; that is, I only observed it being placed into the bladder and unable to pass into the ureters. If the ureters needed to be visualized, a massive CT was brought into the procedure room or OR and placed precisely to examine the proper field. This required an additional technician, ample space and time, and radiation to the patient. Furthermore, the use of CT without being able to visualize fully the ureter placement in a Hilium laser lithotripsy procedure may have been what caused the guide-wires to perforate the weakened ureter wall and cause a failure in surgery; a time-, money-, and energy-consuming process that will now have to be corrected with a percutaneous removal of the stone.

This week as we learned about storyboarding, I applied the step-by-step conceptualization to arguably the most intriguing surgery I have ever witnessed: a robotic-assisted laparoscopic prostatectomy (RALP) using a single-port Da Vinci. As the patient was being prepped in pre-op, the robot was being readied, including the five arms it would eventually use and the two monitors for the other surgeon and others in the room. Once the patient was brought in and anesthetized, the patient was placed in Trendelenburg position to use gravity to move the intestines proximally to expose the prostate. A small, 2cm incision was made just above the umbilicus and the base of the machine ports was placed in the abdomen. A camera, bipolar cautery, scissors, and forceps were the arms attached to the Da Vinci, while a tiny incision was made on the lateral portion of the abdomen to provide the surgeon not operating the robot a port to provide suction, sutures, and other aid to the robot arms.

A minimally invasive procedure such as this has surely evolved from having many pain points to having relatively few, though this operation was not without its flaws. For instance, while the surgeon was removing fascia and fatty tissue from his way to access the prostate, the camera that he used to see the surgical field had to be removed multiple times for manual cleaning. This process required all arms of the robot to be lifted out of the operating area so the camera could be detached, cleaned by hand with a towel, and then reinstalled. Not only did this consume time at multiple points during surgery, but the surgeon had to re-visualize where he was cutting and cauterizing rather than pick up exactly where he had left off. Another shortcoming of the surgery involved the number of times the surgeons had to re-scrub because the robot is not sterile, while the actual surgical field is. For the surgeon and the resident to switch places, whoever was leaving the robot had to re-scrub, making the process of teaching and providing guidance particularly difficult without risking having no surgeons scrubbed in to assist in case of emergency.

The ventral component of the prostate was first isolated, then the dorsal part of the prostate was cut to retract the prostate from the body. A catheter was required as the wall of the prostate is attached to the bladder neck, and during the closing of the bladder wall, the sutures became stuck on the catheter itself, due in no small part to the narrow field of vision and use of robotic arms that do not come with an extended sense of touch for the surgeon. Higher order concepts of laparoscopic surgery with robotic-assistance surely minimizes the risk of complications, small nuisances such as the one that required additional visualization of the catheter to untangle the sutures need to be considered so future surgeries can avoid any additional risk of harm for the patients. While everything was corrected (with some delay) without any harm whatsoever to the patient, a better method of suturing and visualization may have prevented this issue.

Ultimately, the arms of the robot were removed, along with the prostate, and one of the major benefits of a RALP was realized when closing the surgical field took mere minutes. The only two areas that needed closing totaled fewer than 3cm. The patient no longer had a prostate, and the suture area was no larger than if he had gotten a mole removed on his abdomen.

This week, we collected our observations from the past few weeks and reflected upon what might be a tangible solution to the various problems we saw. I decided to focus on how disorganized the surgical field appeared during the adult male circumcision I observed. In order to properly resect the foreskin, numerous clamps were used to keep the area taut and the skin was resected by hand while the other physician either held the resected skin or held the phallus to keep the skin taut. Regardless, the entire procedure seemed somewhat imprecise, particularly when considering the sensitive skin that was being uncovered. That had me thinking that there might be a better way to improve the entire procedure, from organization to precision. In the form of a needs statement, I addressed it as such:

• Reduce surgical field clutter and improve precision, and reduce duration of operation for adult circumcision.

I amended the statement for its second iteration by changing the “negative” inflected words to positive (i.e. reduce) so that the statement’s improvements all point to the same direction:

• Improve organization of tools, and overall precision efficiency of an adult circumcision.

Following this iteration, I realized that the statement doesn’t adequately reflect on the intended audience. While any and all reduction of complication risk will ultimately be bestowed on the patients, This improvement would be designed to improve physician experience. Thus, the statement was amended:

• Improve tool organization, overall efficiency, and precision for physicians performing adult circumcisions.

This week, we began conceptualization of the need we identified: a redesigned method for taking a prostate biopsy. We focused specifically on the shortcomings of the current method, which includes an ultrasound-guided transrectal prostate biopsy gun that requires two people to operate, only allows for one biopsy to be taken before having to remove the device and reload it, and produces a loud, startling sound upon use. We are trying to develop a solution that will reduce the time, improve the experience for both physician and patient, and not need two people to operate.

While brainstorming this idea, we have started to develop a concept of a design that could be feasible, and we have included the following product requirement definitions (PRDs):

1. The device shall be used for prostate biopsy.
2. The device shall be used in clinic for patients who have a measured PSA greater than 4.
3. The device shall collect one biopsy core at a time.
4. For each of the six collection regions (two biopsies per region), collection should take no more than one minute.
5. The device shall be fully operable by one physician.
6. The device shall fit within a 5000 cc volume.
7. The device shall be spring-loaded but may contain an electrical power source in the form of a battery.
8. If applicable, the electrical source shall last for at least 2 hours.
9. The body of the device shall be made from plastic and any needles shall be metal.
10. The device shall be no louder than 50 dB.
11. The device shall allow for concurrent use of a transrectal ultrasound

This week, we sought to develop our ideas to improve the method for obtaining a prostate biopsy. We thought of three “big picture” items that would enable us to redesign the device that collects biopsies that would improve patient satisfaction/experience, usability for the physician, and time of the procedure. We discussed making the current biopsy gun quieter, adding a pull lever to ready the device as opposed to the current twisting method, and a multi-vial containment unit within the device for immediate sample placement and quick removal. The latter two methods, unfortunately, are out of scope for our current program. We decided to test the sound the device makes when firing and conceive of ideas to make it softer. Ultimately, we determined that the plastic-on-plastic contact generated by the spring mechanism was producing the sound, and a foam pad reduces the sound by 10x. We also considered submerging the device in water, which produces a similar effect, though we are still discussing ways to incorporate this into the device.

To communicate this, we utilized simple concept cards to illustrate our ultimate goals. Our idea in conveying the sound reduction of the biopsy gun, in particular, is important because we believe that the current method may not have had the concern of the patient in mind when designing the product. Our design would help reduce the anxiety and discomfort surrounding the procedure, which would help with overall patient satisfaction and possibly even improve compliance with procedure. We also proved using a very inexpensive foam that this sound reduction can be achieved with negligible increases in price of production.