Reproductive System

Med Device Monday: Safer C-sections

Many medical conditions and complications can be and are diagnosed ahead of time, resulting in planned cesarean sections. Of course, emergencies still happen, and in fact, the National Institutes of Health reports that there has been a rise in the numbers of both elective/planned c-sections, and second stage c-sections in the past 20 years.  

The second stage of labor is the point in delivery when the cervix is fully dilated, and the baby is making its way through the vagina and out into the world. While only 1-3% of c-sections occur at this point in the process, they are, as you might imagine, more dangerous and potentially traumatic for mother and child. When the baby's head may already be in the birth canal and doctors have to reach farther into the body, risks are higher and include tears or damage to the cervix, vagina, and uterus, hemorrhage, and extended hospital stays. 

In fact, some reports are that up to 57% of mothers who have a second stage c-section experience some of these complications. 

Fetal pillow is a new medical device from Safe Obstetrics, and it aims to reduce these complications by getting the baby's head out of the birth canal prior to a second stage c-section.

Photo from safeobstetrics.com.

Photo from safeobstetrics.com.

Fetal pillow consists of a small inflatable device that is inserted into the vagina, and then moved down below the baby's head, between it and the coccyx to prevent injury. An attached tube is used to fill the "pillow" with saline and push the baby's head out of the birth canal and back into the uterus. 

When used correctly, this simple, Class II prophylactic device can result in safer, easier births with better patient outcomes for both mother and baby. It reduces complications and length of hospital stays, cuts down on blood loss, and reduces chance of injury to mother and child. 

I love seeing devices like this come into the marketplace! A true win for all in the form of a beautifully simple and effective solution.

 

Further reading:

Fetal pillow device classification

You can see actual footage (warning: this is not a cartoon) of the fetal pillow being used during a live c-section

Med Device Monday: Artificial Womb

Here at Med Device Monday, we explore a variety of topics. From specific medical devices to the role of technology to what FDA has been up to. Today we're talking about a device that's not yet on the market, but which certainly makes it seem like the future is now!

It wasn't that long ago that it was common for women and babies to die in childbirth. As American medicine advanced and healthcare improved along with our understanding of safe labor and delivery, women survived more and babies did too. As time has marched on, fetal viability has increased, while time necessary in the womb has decreased: fetuses can now sometimes survive after just 22 weeks in utero. It appears that time may only continue to shorten as we see the introduction of artificial wombs. 

Before we go further, let's be clear: the best place for a developing fetus is inside a healthy and willing mother. The ideal is for babies to stay inside and develop in their natural environment for as long as they need to, because the earlier a baby is born, the higher the risk for complications, lifelong medical problems, and death. But as we know, remaining in utero is not always possible. And if babies are or need to be born prematurely, technology and medicine continue to advance to save them

Photo from npr.org.

Photo from npr.org.

An article from NPR discusses the artificial womb seen above. While this technology is not yet ready for human fetuses, it has been successful in keeping lamb fetuses alive for about a month. As soon as babies take their first breath of air, their lungs cease developing, which has all kinds of long-ranging implications. The study explains the intent of the device quite nicely:

"In the United States, extreme prematurity is the leading cause of infant morbidity and mortality, with over one-third of all infant deaths and one-half of cerebral palsy attributed to prematurity. Advances in neonatal intensive care have improved survival and pushed the limits of viability to 22 to 23 weeks of gestation. However, survival has been achieved with high associated rates of chronic lung disease and other complications of organ immaturity, particularly in infants born before 28 weeks. In fact, with earlier limits of viability, there are actually more total patients with severe complications of prematurity than there were a decade ago. Respiratory failure represents the most common and challenging problem, as gas exchange in critically preterm neonates is impaired by structural and functional immaturity of the lungs. This condition, known as bronchopulmonary dysplasia, is now understood to be related to an arrest in lung development secondary to premature transition from liquid to gas ventilation, explaining why even minimally invasive modes of neonatal ventilation have not reduced the incidence of bronchopulmonary dysplasia. There is clearly an urgent need for a more physiologic approach to support the extreme premature infant."

The "womb" is a clear plastic bag in which the fetus is placed, along with artificial amniotic fluid. Outside of the bag, a machine attached to the umbilical cord functions as a placenta, a concept the study says has been the subject of research for 50 years. The "placenta" functions as an organic one does, furnishing nutrition and oxygen and taking away carbon dioxide. The fetus is monitored with ultra sounds, and it even gets to hear soothing recordings of a mother's heartbeat.

One thing that I think is extra cool about this device is that it may not only save lives, but will likely provide further insight into fetal development. Check out this little lamb in its artificial environment. It's truly something to behold.

As previously stated, actual approval and usage of a device like this for humans is a long way off. Not only are there obvious medical risks, but there's an ethical discussion to be had, too. The leaders of the study say they have no intentions of using a device like this to increase viability outside of the womb: they say they wouldn't use it on fetuses before 22 weeks. But of course, just the possibility of a device like this does open the door.  There are many factors worth considering for a potential device like this, but from a medical standpoint, it is pretty impressive. 

 

Further reading:

Study of artificial womb on lamb fetuses

NPR article

 

Med Device Monday: C-Section Retractor

When operating in the abdomen via direct incision (as opposed to laparoscopically), it can be a challenge to get adequate and clear access to the area being worked on. For C-sections in particular, the challenges of getting direct and clear access to the uterus are several. Some physicians prefer to move the uterus outside the incision to work on it exteriorly to ensure accessibility. Babies are often born this way, and the uterus is then sutured and returned into the abdominal cavity. This presents it's own challenges, such as nausea and vomiting in the patient.

For physicians who may want some additional help with in situ (within the abdominal cavity) repair—or even because they want to avoid extra-abdominal uterine work—the Alexis C-section Retractor may be a useful tool.

Photo from appliedmedical.com.

Photo from appliedmedical.com.

Approved by FDA in 2006, the Alexis C-Section Retractor is a disposable, single-use medical device that helps facilitate in situ uterine procedures—specifically C-sections—by allowing the uterus to remain in the body and providing clear access to it by aiding in retraction. It comes in two sizes to accommodate different anatomies and incisions. One ring is inserted into the incision and placed around the uterus. The external ring is then rolled down to increase tension, retract the wound, and open up the area for surgical access.

This video illustrates it well (it does show a full C-section birth, so fair warning):

If you prefer a brief animated understanding, this video does not feature the Alexis retractor, but it gives a decent idea of how it's inserted:

It's worth noting that there are conflicting opinions about whether it is best to operate on the uterus in situ or extra-abdonminally (exteriorly). To that end, a 2008 NCBI randomized controlled trial determined that "there is no significant difference between extra-abdominal and intra-abdominal repair of the uterine incision at cesarean delivery, but the number of sutures is lower and surgical time is shorter with extra-abdominal repair, although moderate and severe pain at 6 hours is less frequent with in situ uterine repair".

Ultimately, the Alexis Retractor is a device that provides options. I imagine some surgeons will have their procedures comfortably down pat and don't feel they need an extra set of (proverbial) hands, while some will embrace the opportunity for the extra help.

 

Further reading:

Alexis wound retractor 510(k) summary

NCBI evaluation of the Alexis Retractor (An interesting read.)

Med Device Monday: Bacterial Vaginosis Detection

Bacterial Vaginosis is a relatively common condition in which an overabundance of certain bacteria upsets the balance in the vaginal environment, which can lead to unpleasant symptoms and discomfort. It's also known more generally as vaginitis or vaginosis: common symptoms can indicate a variety of conditions and causes (Bacterial Vaginosis (BV), Trichomoniasis (TV), and Vulvovaginal Candidiasis (VVC)–more commonly known as a yeast infection), making it difficult to know exactly what a patient is presenting with and thus how to treat it. While BV can be inconvenient and unpleasant, it can also lead to complications if left untreated: low birth weight, premature birth, miscarriage, and increased risk of contracting an sexually transmitted disease (STDs) are all potential complications.

It's not known exactly how BV's bacterial imbalance occurs. Although it affects sexually active women almost exclusively, it is not a sexually transmitted disease or infection (STD, STI) though it it is commonly perceived as such. (The CDC offers a "Fact Sheet" on BV with basic info, symptoms, etc., and interestingly, although the CDC website explicitly states that BV is not an STD, it is listed in the STD section of their site.)

Screenshot from molecular diagnostics.bd.com.

Screenshot from molecular diagnostics.bd.com.

BV, TV, and VVC are commonly treated with a single dose of oral antibiotics and/or vaginally inserted antibiotic creams. Because of the overlapping symptoms of these conditions, pinpointing the most effective antibiotics has, until recently, been difficult. Prescribing the wrong antibiotic to correct the balance can lead to prolonged symptoms and infection. 

Enter the BD MAX™.

Granted just last week via the de novo pathway, you can read FDA's approval letter here. This simple in-office vaginal panel pinpoints the exact bacterial levels present in the vagina, and thus allows doctors to prescribe the precise medicine needed to treat the infection.

This press release from BD sums up the difficulties with vaginal infections, their diagnosis, and the need for this device quite nicely. I recommend reading the whole thing but this bit in particular sums up the importance of this device:

""Vaginitis is highly prevalent, with large gaps in clinical management that improved diagnostics could help address," said Dr. Mark Martens, MD, FACOG, Shair, Dept. of Obstetrics and Gynecology Jersey Shore University Medical Center, part of the Hackensack Meridian Health. "Traditional methods used to detect vaginitis can be challenging due to the presence of many interfering substances in specimens, the large number of mixed infections, and the subjectivity of these methods. A multiplex micro biome-based real-time PCR assay has the potential to help clinicians improve patient management and help laboratories increase workflow efficiency."  

Vaginal infections result in more than 10 million office visits each year in the US, with up to 75 percent of women experiencing at least one case of Vaginitis (VVC, TV) or Vaginosis (BV) in their lifetime. As many as half the women who suffer from vaginal infections incorrectly assume it is a simple case of a yeast infection and attempt to self-treat with over-the-counter options before consulting a clinician. Additionally, inaccurate and inconsistent diagnosis of these conditions can leave up to 30 percent of women seeking treatment with the wrong diagnosis. This can lead to continued symptoms, repeat visits, inappropriate or missed treatment and unnecessary associated health care system costs. In addition to irritating symptoms that disrupt quality of life, these infections can have serious risks, including pre-term or low birth-weight babies, late term miscarriage, and increased risk of STI transmission or acquisition such as HIV and Pelvic Inflammatory Disease (PID)."

A personalized diagnosis that will allow for precise treatment and potentially avoid further complications, expense, and repeat treatments is certainly a victory for women and reproductive health!

 

Interested in further reading? I work exclusively with medical devices, but you can read FDA's guidance doc for developing antimicrobial BV drugs here.