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Improved Surgical Treatment of Pelvic Organ Prolapse

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
93881
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
HD060352
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
KEY TECHNOLOGIES, INC.
40 EAST CROSS STREET BALTIMORE, MD 21230-
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2009
Title: Improved Surgical Treatment of Pelvic Organ Prolapse
Agency: HHS
Contract: 1R43HD060352-01A1
Award Amount: $172,017.00
 

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 rela ted 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 an d 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 lar ge 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 pr actice 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 (r emoval 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 G ynecologist, 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 mo ckup 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 ass ess 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 th at 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 operat ive morbidity, shorten hospital stays, and reduce recovery time.

Principal Investigator:

Keith W. Lipford

Business Contact:

Brian Lipford
jregan@keytechinc.com
Small Business Information at Submission:

KEY TECHNOLOGIES, INC.
40 EAST CROSS STREET BALTIMORE, MD 21230

EIN/Tax ID: 522079319
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No