Minerva

A device that revolutionizes gynecological care and procedures by replacing the tenaculum, maximizing comfort and minimizing pain.

The tenaculum is a device used in a variety of gynecological procedures and exams, including intrauterine device (IUD) insertions, endometrial biopsies, and more, by over 80 million around the world. Of women who have experienced these procedures, 89% have reported “moderate to severe pain” as a result of the device [1]. The tenaculum is a metal device that contains two sharp points at the end of a long rod that resembles the shape of scissors. These two sharp points puncture the cervical wall at the cervical os, or entrance, to stabilize the cervix and gently straighten the cervicouterine cavity [2]. This is necessary because the cervix and uterus move and rotate with little friction within the body, increasing the potential for uterine perforations. However, this comes at the cost of severe pain, pressure, and discomfort for the patient during these procedures and exams. 

One of the most notable areas of impact that the tenaculum has is with IUD insertions, especially in today’s world, with increasing awareness and recognition of effective contraception. 65% of US women aged 15 to 49 who are sexually active and not seeking pregnancy are using a contraceptive [3]. One of the most effective forms of contraception is an IUD, with a success rate of greater than 99% and useful life of up to 8 years [4], explored by 14% of these women who were using contraceptives [5]. Despite its efficacy, there exists a major fear and stress among biological females for the pain that IUD insertions can cause. Approximately 70% of people who have not given birth reported mild to moderate discomfort from the insertion, whereas 15.5% reported severe pain [6]. The pain felt by patients during the procedure is caused by the tenaculum. Furthermore, expectations of cervical bleeding and pain can cause psychological damage to individuals hoping to obtain an IUD.  Therefore, this necessitates a device that can replace the tenaculum and decrease pain, bleeding, and discomfort during a variety of gynecological procedures and exams, and improve patient experiences. 

[1] Tenaculum: For Over 100 Years Women Have Endured Pain in Gynecology.

[2] Practical advice for avoidance of pain associated with insertion of intrauterine contraceptives.

[3]  Current Contraceptive Status Among Women Aged 15–49: United States, 2015–2017.

[4] What is the Effectiveness of the IUD?

[5] Intrauterine Devices (IUDs): Access for Women in the U.S.

[6] Is IUD Insertion Painful? Expert Answers You Need to Know.

Minerva is a medical device that will replace the need for both a tenaculum as well as dilating rods. It will be inserted by the physician after speculum visualization, where the blunt tips will reach the cervical os. These blunt tips will be controlled through tension wire running through the device connected to a DC servo motor. When the tension is increased, the blunt tips will then expand, creating variable dilation for the cervix. This dilation will create an opening at the end of the device for a working channel, allowing the physician to insert gynecological tools through the cervix, such as an IUD applicator and a sound tool for uterine access. Dilation can be controlled through a potentiometer attached on the side of the grip. This, in conjunction with a custom PCB, controls the DC servo motor to modulate tension. Using this modulable dilation, physicians can work in response to patient feedback during gynecological procedures.

The odds are likely that at some point in their life, a woman will have to undergo a procedure in which the tenaculum is used. Whether it be through an IUD insertion because they want an effective method of contraception in a post-Roe world or an endometrial biopsy to determine if they have cervical or uterine cancer, women across the globe have endured and will endure the pain caused by the tenaculum. Furthermore, there is an incredible amount of fear and anxiety surrounding these gynecological health procedures. Regarding birth control, history has shown that the burden is on women to undergo a form of contraception and take full ownership of the consequences of reproductive health, from birth control pills, the injection, the arm implant, to even the IUD with its incredibly high efficacy. In the 21st century, women’s healthcare does not need to be associated with severe pain and discomfort, such that patients are avoiding certain procedures. They should have an equal opportunity to health without fear. 

By reducing the pain associated with tenaculum-based procedures, Minerva will be able to make the procedures an easier experience for the women who undergo them. This will hopefully reduce the stigma associated with these procedures, allowing for great accessibility for female reproductive health. Reductions in pain medication needed for these procedures and a better workflow for the physicians conducting the procedures will allow for a decreased burden on the OBGYN office and healthcare providers as a whole.

In regards to technological skills, each of the team members of Minerva are seniors studying bioengineering at the University of Pennsylvania, where we have taken extensive classes about computer aided design (CAD), electrical circuitry, and integrated product design. In particular, Jared has taken classes such as Biomechatronics (BE5700), where he has learned how to construct medical devices and mechatronics to serve medical patient needs. Moreover, Quinn was an intern at Johnson & Johnson, where he learned how to design effective tools that surgeons could use in the operating room. With these experiences, Jared and Quinn have ample experience in mechanical design and have led the fabrication process of Minerva.

Furthermore, Jerry’s mother was a cervical cancer patient, where she frequently was involved in procedures that involved the tenaculum. After speaking with her, Jerry was able to receive her opinions on how those procedures could be improved and what features would be necessary to make the procedure safer and less painful. Akshitha has also volunteered in an OB-GYN office at the University of Pennsylvania, where she was able to shadow a physician and observe multiple IUD insertion procedures. From those experiences, Akshitha was able to directly interact with numerous patients who experienced pain from the tenaculum and ask them for features that Minerva could implement in order to improve upon the tenaculum as a cervical dilator and stabilizer.

To understand the needs of the population that we want to serve, our team first set up interviews with over 10 physicians, nurses, and patients that were all involved in the OB-GYN field. We received ample feedback about the IUD insertion process, endometrial biopsies, and other procedures that involved the utilization of a tenaculum and dilating rods for stabilization and dilation purposes. From physicians and nurses, we learned that during a procedure that requires the dilation of the cervix, both a tenaculum and multiple dilation rods are necessary, cluttering the work space and elongating the duration of the procedure as the rods must be inserted one at a time. After conducting calls with IUD insertion patients, we learned that in their experiences, the gripping of the tenaculum is incredibly painful and dilation rods feel incredibly unpleasant in the cervical canal. Furthermore, we reached out to the University of Pennsylvania student community to learn more about the need for an updated cervical dilator. Through social media, we released a survey to individuals who have undergone a procedure that uses the tenaculum, and we asked those individuals to provide us with suggestions and areas of improvement that a device could implement to make future cervical dilation procedures safer and less painful.

Thus, these stories inspired the creation of Minerva. Throughout the design process, we have continued to iterate our product in response to feedback from our physicians, nurses, and patients. With them, we have conducted monthly calls to ask for critiques and improvements that we can make to the device so that physicians, nurses, and patients alike can provide their insights.

Currently, during gynecological procedures involving the tenaculum, a single-tooth tenaculum is used to puncture the cervix to stabilize it, after which dilating rods are used one after another in order to dilate the cervical os to provide uterine access. This is both a time-consuming as well as painful process for patients as a physician must insert rods one after another of varying sizes to increase dilation. Not just this, but they must hold the tenaculum steady on the other hand or they will pull on the cervix causing pain for patients as well. The entire process has the physician’s hands full throughout the procedure. Minerva solves all of these issues, attaching itself to the speculum to free up physician hands as well as stopping any pulling motions on the cervix that might create pain for patients. In addition, through the use of a vacuum, Minerva reduces pain for patients by removing the puncture of the cervical walls. By creating modulable tips, Minerva also allows for variable dilation during procedures. Physicians only need to insert once, causing the least discomfort for patients, and can work off of patient feedback as they increase dilation size during procedures. We expect all of these aspects to increase patient feedback to tenaculum based procedures as well as decrease procedure times. This has the potential to decrease patient hesitancy to procedures involving the single-tooth tenaculum. In addition, this variable dilation has the potential to be applied to not just to gynecological procedures such as IUD insertion, but could also be applied to larger scale dilation such as birth, where devices similar to Minerva, but perhaps on a larger scale, could help increase dilation in cervical oses to relieve patient pain. 

For the next year, we hope to partner with each gynecologist and OB-GYN office in the University of Pennsylvania and Jefferson Health sphere. We have already established a working partnership with Eileen Wang and Sarita Sonalkar at the University of Pennsylvania, and we have been in contact with numerous physicians at Jefferson Hospital. Through these partnerships, we will be able to assist individuals in the Philadelphia community obtain IUD’s and undergo cervical procedures with less pain. We also intend on partnering with other underrepresented communities in the West Philadelphia community, especially those who cannot afford expensive tenaculums, to assist them in gaining access to the Minerva product. Consequently, we can help Philadelphians, regardless of socioeconomic class, experience less pain during gynecological procedures and alleviate the fears of those who are hesitant to get an IUD.

The core technology that defines Minerva is its variable tip dilation through tension wire as well as vacuum based lock. These expandable tips make use of simple hinge point tension expansion that allow for variable dilation in the cervical os. Standard FEM analysis was performed on these hinge points to ensure they could endure intensive load from the cervical muscle. By increasing tension in the wire running through Minerva, the tips of the device expand outward, which in our use case would push against the cervical os causing it to dilate. The vacuum based lock works in a similar method to a syringe, where suction is implemented through the creation of a vacuum against the cervical wall. This is done by manually pulling the syringe backing away. After which, the lock is twisted, holding the pump in place and creating a continuous vacuum force. This is used to stabilize the cervix. 

Currently, our project is at the prototype stage, so it does not serve anybody. At the peak of our device success, we hope that Minerva is a commonplace device in OB GYN offices across the country, assisting procedures like IUD insertions, endometrial biopsies, and more. To get there, next year, we plan to connect with our clinical mentor to instate Minerva into various OB GYN offices around the Hospital of University of Pennsylvania area. To estimate, we expect we could reach 10% of total patients receiving tenaculum-based procedures in the first year, with expected barriers being physician and health system pushback, device approval, and initial patient uncertainty. Given that there are a total of 23,700 appointments at the UPenn Hospital Center for Women, approximately 10.4% of US women receive an IUD (CDC), assume that 20% of women will receive an endometrial biopsy, and assume a 10% penetration into OB GYN offices next year, we expect to serve about 1,400 patients.

Due to the financial implications of this project so far, we have been working with a $600 budget and been primarily relying on free resources available to us through our school and community. In order to continue to develop our device, we will eventually need to secure additional funding to ensure we can keep progressing with this project. From a legal standpoint, we will need to ensure that this product complies with the Food & Drug Administration laws and keep this in mind during the iterative design process. Due to the sensitive nature of women’s health and healthcare, the team may face challenges as we continue to test and survey on the topic. Hopefully, by partnering with hospitals and healthcare settings, we can begin to accurately analyze the efficacy and opportunities for our device to succeed. Finally, we will face barriers to market entry due to existing competitors: the low-cost single tooth tenaculum and Aspivix, a vacuum based tenaculum technology. A full market analysis will be needed to accurately determine pricing of Minerva and best use case opportunities.

We are partnered with the University of Pennsylvania, the Stephenson Educational Laboratory & Bio-MakerSpace, and have a clinical mentor who is employed at the Hospital of University of Pennsylvania. Through these partnerships, we receive access to laboratory working space and tools, advising and mentorship, and funding opportunities. Furthermore, we have 3D printing and laser cutting facilities to assist the development and progression of our project. 

Our key customers are physicians and gynecologists who perform gynecological procedures that involve the tenaculum, and the beneficiaries are the patients who will experience less pain as a result of the replacement of the tenaculum with Minerva. We will provide the physicians with our device, Minerva, as well as disposable plastic covers to ensure sterility. These products will be sold on a per product basis. Because the Minerva costs approximately 40 dollars to produce, we will sell them at a price of 60 dollars, which is still highly competitive with current-day tenaculums, which can cost as much as 80 to 100 dollars. We anticipate that the Minerva will be in high demand as the tenaculum has not been updated in decades, and an alternative to cervical stabilization is heavily needed in order to reduce patient pain.

At this stage of development, Minerva is exploring funding opportunities through various grants offered by the University of Pennsylvania as well as funding from competitions. These include the Rice 360 competition, the University of Pennsylvania’s President’s Engagement and Innovation Prize, and more. As we progress the project and the prototype, we anticipate looking further into donations from friends and family, and exploring more grant funding. Additionally, UPenn is an excellent incubator for startups and we would utilize these resources. Past that, we would propose our idea to various venture capital (VC) firms. On Penn’s campus, there are quite a few VC competitions that happen throughout the year that we could submit our proposal to.