Michael Bello

The first week of CIP was interesting! I contacted my clinical mentors and prepared to learn the basics of the OR. It was a friendly, growing pain scrubbing up and navigating the OR hallways (even though I still get lost sometimes). My first time in the OR, I watched a cranioplasty surgery. This was followed by other reconstructive surgeries such as septoplasty, flap surgery, and maxillectomy.

Most notably, I made observations about a VP shunt revision combined with a duroplasty procedure. I first noticed the intricate setup the nurses made beforehand to ensure a smooth surgery start. Dr. Purnell explained the open-head surgery and what to expect, while RNs noted how many of us were shadowing. The next several hours were a series of observations as I witnessed the durability of the human body.

Ventriculoperitoneal (VP) Shunt Revision & Duroplasty:

Activities –

The purpose of the shunt revision surgery was to replace a previously broken shunt that had cracked at one end. The shunt prevents fluid buildup in the head by redirecting it through a tube to the stomach.

Environment –

The OR typically takes about 30 minutes to an hour to prepare tables, depending on the complexity of the surgery. A key emphasis in the setup is the designation of sterile areas using blue-draped cloths. Additionally, white gloves are used by the surgeons and nurses operating within the sterile area. Outside of that area, nurses and techs wear blue gloves.

Interactions –

During this surgery, a PGY8 resident opened the area to get to the shunt site. He frequently vacuumed excess fluids from the area and cauterized it to prevent infection/bleeding between their incisions. The shunt was installed into the patient’s head using a small motorized drill with screws.

Objects –

The cautery tool was used the most; tweezers and forceps were used to hold parts of the surgery site in place. The shunt, shunt tubing, and wire was used to install a new shunt mechanism and connect it to existing tube paths.

Users –

Dr. Purnell, a PGY8 resident, RNs, anesthesia, assistant surgeons, technicians, and scrub representatives for the shunt instillation kit were involved in the operation.

Good design:

• The shunt is not complicated to install, and the surgery can be replicated many times.

Bad design:

• Unable to track the flow of the shunt without being invasive.
• Shunts must be durable as fluid buildup in the head can lead to poor patient prognosis.
• Tubing must be connected in a series of chains when installing the shunt so the tube stays in the patient’s body.

In the second week of CIP, our team focused on identifying themes, problems, and patents related to the OR/clinic cases we shadowed. 7/2 was my first day in the UI Health clinic; consultations, follow-ups, and minor procedures such as acute keloid removals occurred. Below my journal are notes from various cases I observed throughout the week.

This week, I looked into surgeon experience as a theme and noticed tool distrust was a frequent pattern in many procedures. One specific example is the Zimmer dermatome. This motorized dermatome creates skin grafts by taking a thin layer of epidermis and dermis. My clinical mentor, Dr. Alkureishi, stated that the dermatome’s blade does not clamp evenly, creating an uneven blade distance. He attributed this to calibration and/or dial sensitivity.

• Actions: The skin graft functions by taking the epidermis and some dermis.
• Environment: The operation room’s temperature is set to 68 F to prevent the spread of bacteria. The room has a layout of sutures, plastic carts, and tables containing tools and equipment. The patient is positioned on the bed corresponding to the type of surgery and is covered by sterile draping while an anesthesia tube is connected to the patient’s nose.
• Interactions: The Zimmer dermatome’s blade is lubricated before surgical use, although some can arrive pre-lubricated. It’s then calibrated to the desired cut thickness. The surgeon angles the dermatome as it nears the patient’s skin, similar to an airplane landing. The sliced skin is then placed through a mesher that patterns it in a petri dish under Tefla gauze soaked with saline to prevent the skin from drying out.
• Objects: Zimmer dermatome, Scissors, forceps, blades, Mesher, Gauze, Saline, Petri Dish.
• User: Primary users of the dermatome are Plastic & Reconstructive surgeons, fellows, and residents.

Patent Search –

According to Zimmer, the primary purpose of dermatomes is to cut skin tissue to procure transplantable skin grafts. The tool’s structure has a head with a flat blade held together with a bottom plate. The blade oscillates side to side and is attached to a motor. A key emphasis of the patent is proper assembly to avoid variable cuts; the blade must match the width of the dermatome head.

Per usage instructions, putting the blade in the dermatome upside-down causes dulling/unaligned cuts because of incorrect positioning. Bar controls calibrate skin graft thickness by adjusting the blade depth. The blade won’t align properly if it is not mounted correctly.

Literature Search –

After researching the literature, I found that using incompatible/unlabeled blades caused the most common cause of deep-cut lacerations using motorized dermatomes. Common risk factors causing skin lacerations are improper dermatome assembly, donor site location, and harvesting techniques equipment (Egro et al). However, this article did not observe any significant correlation between skin lacerations and dermatome calibration, citing it as an uncommon issue.

References –

Salisbury, C. M. (2011). Dermatome blade assembly (US Patent No. 8002779B2). U.S. Patent and Trademark Office. Retrieved from https://patents.google.com/patent/US8002779B2

Egro, F. M., Saliu, O. T., Zhu, X., Corcos, A. C., & Ziembicki, J. A. (2020). Dermatome-induced lacerations: An unspoken problem in burn surgery. Journal of Surgical Research, 245, 45-50. https://doi.org/10.1016/j.jss.2019.07.022

In place of Dr. Alkureishi, I shadowed Dr. Patel on Tuesday in OR Room 5. He was performing a maxillectomy on a patient with a Le Fort Type 1 fracture. Even though this was a 4.5-hour operation, Dr. Patel subsequently finished operating in 2.5 hours. The patient’s mouth was held open using a frame that was placed right below the anesthesia tube connected to his nose.

 Dr. Patel is very facilitative with his residents, directing and offering constructive feedback as he performs cautery, irrigation, and vacuuming of excess debris. Dr. Patel performed the drilling, which was later held up by limited screws and motor issues. Upon talking to the scrub representative from Stryker, I learned this stems from incorrect sterilization techniques, which ultimately cause wear damage to the motor over time. This issue fell under the social engineering theme and would be too complex to define as a feasible/viable need. 

A Bovie electrosurgery pencil is commonly used to access the maxilla and surgery sites for reconstructive procedures. Moreover, Dr. Patel detailed his frustrations with the electrocautery device he used– the Stryker SafeAir Smoke Evacuation Pencil. Upon interview post-operation, he recommended performing a secondary literature review of the history of electrocautery patents to provide a proper assessment of the need. 

• A – maxilla surgery, Le Fort I, occlusal guides.
• E – Operation Room with electrocautery and drill setups; anesthesia through the nose
• I – Dr. Patel instructs residents on incision and drainage; Dr. Patel does drilling while the resident vacuums debris. Saline is periodically used to rinse and prevent drill friction.
• O – scalpel, blade, drill, drill bits, drainage tube, mouth gag frame, forceps, hooks, electrocautery tool, saline pump, screws.
• U – Dr. Patel, Residents.

Needs statement Attempt 1 : 

The Bovie is a type of medical device that is used to cut and coagulate biological tissues. It is used primarily in electrosurgery procedures. Dr. Patel confirmed that hemostasis control has been a significant issue in surgery since the initial development of electrocautery tools. There are also needs regarding efficient smoke evacuation, debris buildup on the cautery pencil tip, and the pencil’s user interface. He encouraged me to research problems related to electrocautery, such as infection, hemorrhage, and nerve/tissue damage.

• Population
• Opportunity
• Outcome

Surgeons performing electrosurgery with Stryker Bovies need an enhanced impedance system to minimize delayed bleeding.

Secondary Literature:

Articles:

• https://www.sciencedirect.com/science/article/pii/S0039606096801371
• https://pubmed.ncbi.nlm.nih.gov/31481290/

Patents/supporting patents:

• US9283023B2 
• A hand-held cautery device with a disposable design to aiming to avert accidental activation and difficulty in battery removal.  This patent was filed by Bovie Medical Corp. in 2011. It features an electrical circuit with a detachable power source, an actuator, and coupling component to secure the power supply temporarily.
• US10314642B2 
  • An electrocautery method and apparatus patent includes a system for varying the output intensity of energy applied to an electrosurgical probe. It presents the options for pre-determined profiles and user-selected settings. Sensors measure the voltage, current, impedance, phase angle, temperature, angle, and frequency. Module 108 had multiple power supplies that can conduct automated operations; it can also target specific tissue regions by selectively limiting power to the electrodes.
  • User interface setting, impedance compensation, and advanced features such as dielectric coating are also employed in the apparatus.
• US8672934B2 
  • A patent includes a method for adjusting source impedance and maximizing output by RF generator.

General patent for isolation circuit: 

• US8784415B2: A powered surgical tool with an isolation circuit 
• Commercial solutions
  • Medtronic
  • Ethicon Megadyne 

Market- cost analysis (TAM):

• Poor market viability 
• TBD

Needs statement Attempt 2 : 

Secondary Literature:

• Population
• Opportunity
• Outcome

Needs Statement: Surgeons performing electrosurgery with cautery tools need an enhanced apparatus system to minimize delayed bleeding to prevent post-surgical complications.

Articles:

• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6484569/

Patents:

• SafeAir Smoke Evacuation Pencil
  • Patent for a smoke evacuation system for minimally invasive procedures – WO1999031954A2. 
  • The system includes a filter with a site side, an outlet side, and a fluid conduit.
  • Multipurpose, reduces exposure to the surgical plume’s viral, bacterial, mutagenic, and carcinogenic hazards.

Supporting patents: 

Market- cost analyis (TAM):

IDEO: 

Desirability

• High concern among patients and clinicians about infection risks.
• Porous polyethylene implants favored for their biocompatibility but pose infection risks.

Feasibility

• Challenges in implementing effective infection prevention measures.
• Commercial solutions like surface treatments and coatings.

Viability

• Need for cost-effective, scalable solutions.
• TAM analysis.

New NS: Surgeons and healthcare providers need a reliable method to minimize the risk of infection associated with porous polyethylene implants to promote proper epithelialization and expedite wound healing.

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