Improved Surgical Treatment of Pelvic Organ Prolapse

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43HD060352-01A1
Agency Tracking Number: HD060352
Amount: $172,017.00
Phase: Phase I
Program: SBIR
Awards Year: 2009
Solicitation Year: 2009
Solicitation Topic Code: N/A
Solicitation Number: PHS2009-2
Small Business Information
40 EAST CROSS STREET, BALTIMORE, MD, 21230
DUNS: 007429504
HUBZone Owned: Y
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 KEITH LIPFORD
 () -
Business Contact
 BRIAN LIPFORD
Phone: (410) 385-0200
Email: jregan@keytechinc.com
Research Institution
N/A
Abstract
DESCRIPTION (provided by applicant): The overall objective of this research and development project is to improve treatment of vaginal prolapse, a disorder of the female pelvic floor. Each year, approximately 200,000 women undergo inpatient procedures related to pelvic organ prolapse in the United States and it is expected that this number will rise with the aging population. For patients with loss of apical support (vaginal vault or uterine prolapse), restorative surgery is typically performed to repair and prevent vaginal descent. This has been done in a variety of ways, with the best long-term success rates being obtained with an abdominal procedure known as sacral colpopexy. This procedure is typically performed via laparotomy in which a relatively large abdominal incision is made to access the area in a manner similar to that performed for a cesarean section or abdominal hysterectomy. This procedure has a high success rate but entails the pain and morbidity associated with a large abdominal incision. A small number of surgeons are attempting to perform the sacral colpopexy via laparoscopy or robot- assisted laparoscopic surgery. Although feasible, the current laparoscopic equipment has deficiencies, which makes this procedure difficult and limits its practice to those with advanced laparoscopic skills who are willing to undergo a steep learning curve. The specific aim of this project is to develop an improved laparoscopic approach and instruments that will allow a more efficient performance of the sacral colpopexy procedure. If this operation can be rendered more efficient, i.e., less time consuming, and with a shorter learning curve, it could be transformed into one that is done primarily laparoscopically, similar to what occurred with cholecystectomy (removal of the gallbladder). As with cholecystectomy, transforming sacral colpopexy to a laparoscopic-based operation will decrease operative morbidity, shorten hospital stays, and reduce recovery time. Dr. von Pechmann, a board certified Obstetrician and Gynecologist, and Fellowship trained Urogynecologist, has developed a concept that will facilitate this procedure using novel laparoscopic tools and procedures. A project team of design engineers and practicing surgeons, including Dr. von Pechmann, propose to join together to develop and implement these concepts. Prototype tools and procedures for the laparoscopic sacral colpopexy will be created, focused on functionality, sufficient to demonstrate the feasibility of this procedure. An anatomical physical mockup intended to demonstrate the novel laparoscopic technique and instruments will be designed and constructed to simulate the physical constraints and conditions of the sacral colpopexy. In addition, an outside panel of medical peers will be formed to assess the viability of the approach and tooling, and to provide feedback for improvements. PUBLIC HEALTH RELEVANCE:Each year, approximately 200,000 women undergo inpatient procedures related to pelvic organ prolapse in the United States and it is expected that this number will rise with the aging population. A current surgical repair procedure (known as sacral colpopexy ) is typically performed via laparotomy in which a relatively large abdominal incision is made to access the pelvic area in a manner similar to that performed for a cesarean section or abdominal hysterectomy. The specific aim of this project is to develop an improved laparoscopic approach that will allow a more efficient performance of the sacral colpopexy, which is expected to decrease operative morbidity, shorten hospital stays, and reduce recovery time.

* Information listed above is at the time of submission. *

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