A containment system for morcellation

September 13, 2016

The system's design prevents leakage to ensure safety.

 

 

Dr Brown is Professor, Levine Cancer Institute, Carolinas Health Care System, Charlotte, North Carolina.

The benefits to the patient of minimally invasive surgery are widely known and accepted, and more than 60% of hysterectomies performed in the United States are now done laparoscopically or with the assistance of a robot.1 For decades, the process of removing a large fibroid uterus through a small outlet (port sites or the vagina) has been accomplished through morcellation, in which the uterus is removed in smaller segments.2

Morcellation has been performed either by hand with a scalpel or scissors or using a device with a rotating blade that removes cylinders of specimen through the port site, vagina, or abdominal incision (power morcellation).

Recently, the low but present risk of dissemination of undetected malignancy has limited use of power morcellation in patients undergoing hysterectomy. Consideration of this risk prompted the US Food and Drug Administration (FDA) to issue updated guidelines on use of the power morcellator in 2015, which cautioned against using the device in certain women with uterine fibroids and mandated informed patient consent.3 The recommendation was made by the AAGL, Society of Gynecologic Oncology, and other organizations to develop containment systems so that morcellation might safely be performed, allowing minimally invasive surgery without the risk of dissemination during fragmented removal through small incisions.4-7

Against this background, the PneumoLiner (Advanced Surgical Concepts Ltd, Wicklow, Ireland) was developed and FDA-approved as the first device to allow total containment of tissue, cells, and fluid during a laparoscopic power morcellation procedure (Class II device).8

 

 

What is the PneumoLiner?

The PneumoLiner is a total containment system indicated for use as a multiple-instrument port and tissue containment system during gynecologic laparoscopic surgery to enable isolation and containment of tissue considered benign that has been resected using power morcellation. The system consists of a laparoscopic multi-instrument port and contains: (1) a retractor introducer; (2) a retractor; (3) a multilumen port, or “boot assembly”; and (4) a tissue pouch, or PneumoLiner, with introducer shaft and plunger (Figure 1).

Photo courtesy of Advanced Surgical Concepts

Notable features include single-port technology, which allows the camera, laparoscopic instrument, and bag to be introduced through a single opening without risk of intraperitoneal spillage. The bag is sizable, measuring 30 cm with a wire ring at the opening to facilitate specimen placement within the bag. The key to using this device is that the bag insufflates, pushing intraperitoneal contents away from the specimen and maximizing the operative area. This keeps the specimen contents within the bag and limits the risk of injury to surrounding structures.

The system is compatible with bipolar or electromechanical laparoscopic power morcellators measuring between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length. The power morcellator should have an external component that allows for proper orientation of the laparoscope to perform a contained morcellation.

 

 

Is the device safe and effective?

Yes. The PneumoLiner has been reviewed by the FDA through the de novo application process for clearance to market. Because this device is unique, in that it allows laparoscopic power morcellation within a containment system providing vision and space, the FDA required assurance that the design, materials, mechanical properties, and usability of the PneumoLiner were sufficient to prevent any leakage of fluids, cells, or tissue.

Mechanical testing, filtration testing, and immersion testing demonstrated safety, efficacy, and impermeability with no leakage of fluids, cells, or tissue. Morcellation simulation testing and design validation were performed to determine if surgeons can be trained to use the device in a clinical setting without compromising the liner component of the device. Thirty-one surgeons participated in a dry laboratory and a porcine laboratory, and there were zero instances of loss of pneumoperitoneum, tissue loss, bag leakage, or bag compromise when tested at the completion of the procedure, thereby validating the design, materials, and mechanical properties of the PneumoLiner.

The device’s usability was validated through a “show, assist, do” training methodology using a PneumoLiner Training Rig. Components consisted of introduction and description; video and live demonstration; assisted device set-up and use; subject trial; and evaluation of training effectiveness. A validation questionnaire was completed by each study coordinator and study subject. Each of the 11 component steps was able to be successfully demonstrated by 100% of the participants. This confirmed the usability of the PneumoLiner.

As recognized during the FDA review of the product, identified risks to health include adverse tissue re action, infection, intraperitoneal tissue dissemination, traumatic injury to non-target tissue/organ, hernia through abdominal wall incision, and prolongation of procedure and exposure to anesthesia. These issues were mitigated by a number of measures, including biocompatibility, labeling, training, validation, and performance testing.

A press release issued by the FDA on April 7, 2016, stated, “The containment bag was found to be impermeable to substances that were similar in molecular size to tissues, cells and body fluids, and other testing determined that the inflated bag provided adequate space for surgeons to perform morcellation with good visualization. Stress testing to evaluate the bag’s mechanical strength demonstrated that the device could withstand forces in excess of those expected to occur in actual clinical use.” The PneumoLiner was given clearance to market on April 7, 2016.

 

 

Selecting patients and procedures

Patients are candidates for use of the PneumoLiner if they undergo minimally invasive surgery, either through a laparoscopic or robotic platform, and have a uterine specimen that is larger than the orifice used to remove the specimen. Typically this would be the case for a uterus with leiomyomata that cannot be extracted intact through the vagina following total hysterectomy, supracervical hysterectomy, or myomectomy.

The FDA warns against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. The contraindications recommended by the FDA include women who are perimenopausal or postmenopausal, or are candidates for en bloc tissue removal, or if the tissue to be morcellated is known or suspected to contain malignancy. Despite the demonstration that the PneumoLiner maintains its integrity through routine use, contraindications for use with perimenopausal patients have remained in place for contained power morcellation, even with the use of the PneumoLiner. According to communications from Advanced Surgical Concepts, the contraindication will be removed when sufficient clinical data have been generated that demonstrate the safety of the PneumoLiner, in particular for acute failure that might occur during surgery.

Therefore the PneumoLiner can be considered for use during a power morcellation procedure in appropriately screened, low-risk women undergoing a minimally invasive total or supracervical hysterectomy or myomectomy. Patients should not be perimenopausal or postmenopausal, and should have normal cervical and endometrial cytology.

 

 

How do I use the PneumoLiner?

Patients on whom the PneumoLiner is used should undergo informed consent preoperatively. Place a patient in the dorsal lithotomy position and prep and drape her abdominally and vaginally in the usual sterile fashion. Detach the specimen using the technique of your preference, which may be laparoscopic or robotic, and may include the uterus, cervix, tubes, and/or ovaries. The umbilical port may be as large or small as a surgeon prefers, but it will later be enlarged to place a multilumen port.

Once the specimen is detached, remove the umbilical port and enlarge the incision to approximately 2.0 cm to 2.5 cm. Place the retractor introducer through the umbilical incision into the peritoneal cavity. Introduce the plunger and deploy the retractor, delivering the distal ring on the retractor (Figure 2A). Remove the plunger, leaving the retractor with an intraperitoneal ring and an external ring; pull the retractor sheath externally to make the external ring taut against the skin (Figure 2B).

Pull the ribbon externally to retract the incision, allowing passage of laparoscopic instruments, providing a gas-tight seal between the device and the incision, and anchoring the multilumen port, or “boot assembly.” Trim the excess sheath plastic. Attach the boot assembly to the external ring of the retractor. This assembly consists of 2 insufflation ports (for distention and venting) and 2 instrument ports. The instrument ports consist of a large instrument valve port for introduc ion of the PneumoLiner pouch and power morcellator, and a 5-mm valve port that can accommodate a 5-mm instrument. Place the 5-mm zero-degree camera through the 5-mm opening in the boot assembly and then place the introducer with the preloaded PneumoLiner through the large opening in the multilumen port (boot assembly). Depress the plunger, thereby introducing the PneumoLiner into the peritoneal cavity. The wire will gently deploy intraperitoneally, opening the 30-cm bag for easy access. The bag should be open with the dependent portion of the bag in the pelvis (Figure 2C).

Images courtesy of Olympus America Inc.

Remove previous ports from the patient to eliminate the risk of damage to the bag. A laparoscopic instrument can be used through the other umbilical port to move the tabs on the bag to allow optimal positioning for placing the specimen into the bag (Figure 2D). Place the specimen into the bag using the laparoscopic grasper through the 5-mm opening in the boot assembly (Figure 2E).

Exteriorize the collar section of the PneumoLiner by pulling on the attached tethering strings, leaving the specimen inside the bag. With the boot assembly uncapped and the periphery of the bag (2-3 cm) exteriorized, reattach the boot assembly within the plastic collar of the exteriorized PneumoLiner, thereby securing the plastic bag to the port (Figure 2F).

 

 

Attach the carbon dioxide inflow to the insufflation port on the boot assembly and insufflate the bag with carbon dioxide, effectively maximizing the operative space around the specimen inside the bag and pushing the intraperitoneal contents (eg, bowel) away from the specimen. The printed grid pattern allows for distinction between the tissue sample and the retracted viscera.

Introduce the power morcellator through the large opening in the boot assembly, grasp the specimen and extract it with the morcellator under direct visualization. Take care to keep the rotating blade in view of the camera and away from the bag (Figure 2G).

Once the bulk of the specimen has been removed, desufflate the PneumoLiner and remove the bag and port, leaving any residual pieces of the specimen within the bag. The bag can be tested for integrity at the completion of the case (Figure 2H). Pneumoperitoneum may be reestablished to inspect the peritoneal cavity for hemostasis and tissue integrity. The vaginal cuff can be closed by reinserting the other ports that were previously removed, or you may elect to close the vaginal cuff before removing the specimen.

Images courtesy of Olympus America Inc.

It may be advisable to place the camera into one of the other ports to view the umbilical port and ensure that the umbilical retractor sheath is free from any intestinal involvement.

Pull the ribbon to remove the retractor entirely (Figure 2I). Remove all ports, evacuate the gas, and close the fascia. Perform subcuticular closure and apply sterile dressings.

 

 

How do I learn to use the PneumoLiner?

Surgeons will have to pass a training program to be credentialed to use the PneumoLiner. Similar to the validation laboratory conducted in order to obtain FDA approval, surgeons will participate in a “show, assist, do” training methodology. Each of the 11 component steps will be demonstrated and performed, so that surgeons are trained to use the PneumoLiner safely and effectively while maintaining the integrity of the liner.

This training program will be conducted by representatives from Advanced Surgical Concepts and will be offered throughout the United States.

Reimbursement

No specific reimbursement is provided for containment devices, or for any other device. This is built into the surgical cost and would be billed by the hospital as a part of surgical procedure expense.

Patient counseling

According to the boxed warning recommended by the FDA, patients should be informed that the use of power morcellators during fibroid surgery may spread cancer and decrease long-term survival. This information is available on the FDA website.

Dr Brown has no conflicts of interest to report in respect to the content of this article.

 

References

Turner LC, Shepherd JP, Wang L, Bunker CH, Lowder JL. Hysterectomy surgical trends: a more accurate depiction of the last decade? Amer J Obstet Gynecol. 2013;208(4):277.e1-7.

Steiner RA, Wight E, Tadir Y, Haller U. Electrical cutting device for laparoscopic removal of tissue from the abdominal cavity. Obstet Gynecol. 1993;81(3):471–474.

Updated laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. Accessed June 11, 2016.

Brown J. AAGL Statement to the FDA on power morcellation. J Minim Invasive. Gynecol. 2014;21(6):970–971.

AAGL Practice Report: Morcellation during uterine tissue extraction. J Minim Invasive Gynecol. 2014;21(4):517–530.

Society of Gynecologic Oncology. Position statement on morcellation. https://www.sgo.org/newsroom/position-statements-2/morcellation/; December, 2013. Accessed June 11, 2016.

ACOG: Power morcellation and occult malignancy in gynecologic surgery: A special report. www.acog.org; May 2014. Accessed June 11, 2016.

FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494650.htm; April 2016. Accessed June 11, 2016.