Redesigning theVaginal Speculum to Improve Practicality

and Patient Comfort: Design Brief

Victoria Hicks, Laura Riley, Rena Tchen, Caressa Watson

University of Pittsburgh, Undergraduate Department of Bioengineering

Problem

Cervical cancer once was the leading cause of deaths due to cancer for women in the United States. However, during the past 4 decades, the incidence and the number of deaths each year from cervical cancer have declined significantly, primarily because of the widespread use of the Papanicolaou (Pap) test to detect cervical abnormalities [1]. The Pap test is a gynecologic screening method for the detection of premalignant and malignant processes in the cervix. Because the Pap test is the primary contributor to the detection of such diseases as cervical cancer, pelvic exams are recommended by physicians annually for all women who are either sexually active or over the age of twenty-five [2]. A study performed by the University of Washington School of Medicine reports that ten percent of the women who had never had sex with men said they never had a Pap smear, while 23 percent had not had a Pap smear in three years or more [3].

Gynecological exams are routinely performed using the vaginal speculum which is inserted into the vagina in order to dilate it for examination of the vaginal walls and the cervix. A vaginal speculum consists of a hollow cylinder with a rounded end that is divided into two hinged valves.While the speculum is effective, it presents compromised visualization and cervical access to the physician. The current speculum design does not prevent caving of the vaginal walls which disruptsadequate visualization of the cervix, particularly problematic with women who have had multiple children. In addition, the speculum is very uncomfortable to the women receiving exams due to the pressure the device places on the bladder when opened during an exam. Many physicians attribute the unwillingness of many women to receive regular pelvic exams to the discomfort experienced during the exam. Thus, increasing practitioner visualization and cervical access and decreasing patient discomfort during the exam by modifying the design of the vaginal speculum could reduce the number of women who die each year from preventable causes like cervical cancer.

Potential Customer

The primary beneficiaries of this device would be women who receive pelvic exams and practitioners in the gynecologic field who must perform the exams. In addition to pelvic exams, the device is utilized in other gynecologic procedures that are performed less frequently, such as the colposcopy.

Technical Specifications

The device will need to be comparable in structure, function, efficacy and ease of use to the current specula utilized. Its dimensions will be comparable to the vaginal specula which are currently used in practice. Specifically, it will maintain the dimension of the Welch-Allyn bivalve speculum. The barrel length will be approximately 15.0 cm, the circumference of the valves will be about 1.5 cm and the length of the handle will be approximately 12.0 cm. The maximum diameter of the opened valves will be about 30.0 cm. Because our device should be able to be applied to women of all sizes, it must have a minimal insertion size, but be able to be scaled up for clinical needs. In addition, the device should be operable with one hand and be able to be temporarily locked into an open position in order to promote physician performance during a pelvic exam. The device will expand downward toward the rectum when opening in order to remove pressure from the bladder during an examination and thus improve patient comfort. While the opening mechanism of the device will be different than the specula currently utilized by clinicians, it should open in a way that is familiar and intuitive to clinicians. The device will also have a mechanism to allow for the vertical adjustment of the handle, creating a second degree of freedom. Further, the device should allow for maximum visibility of the cervix and vaginal walls.

References

  1. “Statistics.” Department of Health and Human Services: Centers for Disease Control and Prevention. (2007) <
  2. Abole, C. “Cervical cancer: Most Threatening, Most Preventable.” MedicalUniversity of South Carolina (2000). <
  3. Neary, W. “Women should have regular Pap smears regardless of sex partner's gender.”