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Women's Health Surgical Device Design

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The Problem and Opportunity

Salpingectomies are required and elected by millions of women every year as the final surgical solution in range of reproduction and health issues. The laparoscopic procedure is plagued with pain points for both the surgeons and patients including complications maintaining hemostasis of uterine blood supply, disruption to ovarian hormones or blood flow (results in pain and mood changes), peritonitis, scarring, cramping, and spotting. There exists substantial need for a breakthrough device that reduces operator complexity and enables a truly minimally-invasive salpingectomy possible.

As the typical 3 laparoscopic ports (and tools) must be condensed into one hysteroscopic point of access a novel all-in-one manipulation and excision device is necessary.

Client

Hologic Inc

Services

product and market research, solutioning and prototyping

The Solution

My Intellectual Property is based on combining trans-vaginal laparoscopy (TvL) with a dexterous cautery implement and offers an alternative surgical access method to safely excise the Fallopian tubes via hysteroscopic trans-vaginal laparoscopy.

TvL offers an alternative to abdominal laparoscopy to access the tubes, ovaries and fossa ovarica in subfertile patients. The basis of the procedure is a laparoscopy performed with a
 specially developed needle-trocar system used to gain access to the abdominal cavity through a needle puncture of the posterior fornix. Performed under local anesthesia or sedation with the patient in a dorsal decubitus position and using prewarmed saline as a distension medium, TvL allows complete exploration of the tubo-ovarian structures without supplementary manipulation. The combination transvaginal endoscopy and dexterous cautery-tool permits the most complete exploration of the reproductive tract and can be used as a first-line investigation of female fertility in a one-stop infertility clinic. [However, in the absence of a panoramic view procedures will be limited to non-emergency interventions.]

Advantages over traditional laparoscopy in that it does not require abdominal incisions (reduced recovery time) and has the capability of being conducted in an outpatient office setting with local anesthesia. The use of saline solution as a distension medium affords better visibility to the surgeon (carbon dioxide causes organs to collapse with gravity) and, further, TvL has statistically similar accuracy to laparoscopy (96.1% concordance). Additionally, because the head down position is not required, and as the procedure is carried out entirely below the peritoneum; the risk of peritonitis if the bowel is inadvertently punctured is eliminated. 

The endoscope used for TvL is a 2.9-mm endoscope with a 30° angled optical lens. Fixed in the single flow outer trocar, the total diameter is 3.4 mm. The same 2.9-mm endoscope is used for operative procedures with an outer operative sheath of 5-mm diameter with one working channel, allowing the use of 5 Fr instruments such as scissors, biopsy and grasping forceps, bipolar needles and bipolar coagulation probes. Procedures are always started with the same spring-loaded needle system. A specially developed obturator allows easy exchange between the diagnostic and operative instruments. My specialized salpingectomy instrument eliminates the need for 5 instruments into 1 grasping and (bipolar current) cautery tool. The surgeon can carry out the procedure with a single hand, which can lead to savings in time and cost. 

User Research and Market Analysis

Who are the patients and what are they having the procedure:

  • Elective: preventive measure for ovarian cancer, to become sterile, to increase efficacy of IVF (in cases of hydrosalpinx), and as part of hysterectomy or oophorectomy (salpingo-oophorectomy

  • Non-Elective: treatment for tubal/ovarian/endometrial cancer, ectopic pregnancy, prolapsed tube, or hydrosalpinx

 

Who are the physicians and how often do they perform the procedure:

  • Obstetrics & Gynecology/54%

  • Surgery/29%

  • Colon & Rectal Surgery/8%

  • Gynecologic Oncology/4%
              

Patients' tolerance and acceptability:

  • In a randomized controlled study by Cicinelli et al. [2006] demonstrated that TvL under local anesthesia was well tolerated in outpatient setting. This confirms the observation of Gordts et al. that the mean pain score on an analogue pain scale (0–10) for TvL performed in an office setting under local anesthesia was 2.7 (SD ±1.5). Only five (8%) of the patients marked a score above 5 and 96% of the patients regarded a repeat procedure under the same circumstances as acceptable.

  • Moore and Cohen et al. reported pain scores for cannula insertion, mid procedure, and end procedure as 2.1, 1.4, and 0.5, respectively, in 17 patients who received conscious sedation.

  • Patients resumed their normal activity after 1–2 days.

Related and similar procedures that could benefit:

  • Fertility assessment and tubal patency testing 

  • Ovarian drilling procedure for Polycystic Ovarian Syndrome (PCOS)

Physician end user architypes:

  • "The Caregiver": provide a tool that will help perform a lower risk salpingectomy than laparoscopic surgery

  • "The Quality of Lifer": provide a tool that will reduce the chance of salpingectomy complications and adverse events

 

Why Hologic:

  • Strategically expand into new GYN health spaces and offer avenue for minimally invasive and reduced complexity salpingectomy procedure

  • No existing versatile and specialized salpingectomy devices on the market

  • Hologic has a strong brand presence within hysteroscopy and necessary KOL relationships

  • Collective buying power to bring affordable medical device to market and increasing accessiblity to phycisians who can perform procedure can grow the market

Barriers to entry:

  • Laparoscopy is a common procedure, and there are many trained and experienced physicians (accepted, low risk)

  • The wide field of view with laparoscopy is a strong advantage for the incumbent

  • Laparoscopy can be performed in the presence of vaginal deformity.

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Prototyping and Iteration

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