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Boston Scientific : Patent Issued for Method for Treating Prolapse and Incontinence (USPTO 9414902)

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08/25/2016 | 10:20pm CEST

By a News Reporter-Staff News Editor at Biotech Business Week -- From Alexandria, Virginia, NewsRx journalists report that a patent by the inventor Miller, Dennis (Whitefish Bay, WI), filed on November 4, 2010, was published online on August 16, 2016 (see also Biotechnology Companies).

The patent's assignee for patent number 9414902 is Boston Scientific Scimed, Inc. (Maple Grove, MN).

News editors obtained the following quote from the background information supplied by the inventors: "The present invention relates in general to a system and method in the field of prolapse treatment. More particularly, the present invention relates to a system with multiple components, and a method for surgically correcting tissue wall prolapse using the same. Specifically, a preferred embodiment of the present invention is a kit that has the following components: a pre-cut shaped mesh graft and a graft delivery device.

"As is known to those skilled in the art, the treatment of vaginal wall prolapse has been hampered by high failure rates. The main reasons for failure have been the inherent weakness of the tissue being re-approximated and the inability of the repaired tissue to withstand the forces applied by the abdominal cavity bearing down from above. In the last decade, one major advance has been the addition of grafts to reinforce those repairs. While this phenomenon has been gaining widespread acceptance, there lacks a consensus regarding how to affix the graft under the vaginal wall to best maintain durability and vaginal caliber.

"A number of prior art patents and publications are directed to various methods of treating and preventing recurring vaginal wall prolapse. For instance, U.S. Pat. No. 6,102,921 (the ''921 patent'), incorporated herein by reference, discloses a mesh graft material for treating vaginal prolapse. Further, U.S. Pat. No. 6,638,284 discloses an apparatus configured for delivering a mesh graft like that of the '921 patent for treating vaginal wall prolapse.

"The most commonly accepted procedure for surgical treatment of pelvic organ prolapse is an abdominal sacrocolopopexy (ASC). The procedure was originally described as being performed through an open incision, i.e., laparotomy, wherein one end of a wide graft was attached to the vagina with multiple sutures and the other end attached to the sacral promontory after opening the enclosing tissue layer known as the peritoneum. The procedure has been refined over the years and has multiple subtle variations. It is acknowledged that the procedure, as described, has several limitations and, as such, the procedure is not utilized by all surgeons despite its overall level of success as compared to other treatments. For example, opening the peritoneum and sewing within the retroperitoneal space requires special skill and there is significant risk of bleeding. In addition, it is particularly challenging to apply the correct amount of tension to the graft needed to elevate the vagina and then fixate the graft at that tension.

"Further, this approach has been associated with an increased risk of serious bowel complications, including potentially life threatening bowel obstruction. To avoid these complications, some surgeons have begun to attempt this procedure laparoscopically, at times employing known robotic techniques. However, this also creates a number of technical challenges as laparoscopic knot tying is a skill possessed by only a limited number of surgeons.

"One alternative treatment approach for prolapse has been to introduce the mesh transvaginally. The evolution of transvaginal mesh procedures has produced several deployment devices to increase safety and make the procedures accessible to more surgeons. One procedure includes the use of a Pinnacle.RTM. device, made by Boston Scientific Corporation, having a dilator for bringing the mesh into place along with a limited access suture capture device (known commercially as a Capio.RTM., made by Boston Scientific Corporation). However, some surgeons prefer to not introduce the mesh directly through the vagina due to potential inherent infectious and sexual complications associated with transvaginal introduction. PCT publication WO/2007/109508 discloses a method and system for treating vaginal wall prolapse by transvaginal insertion of a mesh graft, and is herein incorporated by reference.

"Accordingly, it has been desired to provide a device and method of treating vaginal prolapse that combines the ease of use of the transvaginal meshes, and in particular, leveraging a suture capture device and Pinnacle.RTM.-like dilators to employ the mesh laparoscopically, with the known advantages of the ASC procedure, i.e., ease of reaching internal structures necessary for implementing the mesh. Enhancements to the shape of the graft and the method of attachment to both the vagina and the sacrum provide increased safety and ease of use. The present invention eliminates the need to suture the graft to the sacrum. These enhancements thereby allow a greater number of patients to be treated using a minimally invasive prolapse treatment."

As a supplement to the background information on this patent, NewsRx correspondents also obtained the inventor's summary information for this patent: "The present invention is directed to a system and method for preventing recurring prolapse. The system preferably includes a multiple component kit comprising a graft delivery device that is modified for use with the method of the present invention. For example, a Capio.RTM. device, or similar such device, may be utilized in practicing the method of the present invention. The kit further includes a mesh graft having a narrow extension and a body configured to cover both the anterior and posterior wall of the vagina. The precut mesh may be a single joined piece composed of an anterior body and a posterior body connected in the extension or may be two separate meshes, both with narrow extensions. The novel advantage of the two separate meshes is to provide independent adjustment of the anterior and posterior walls. With a wide body mesh, it would be impractical to have two separate pieces lying over each other and having increased mesh load. The narrow extensions make it possible to have two independent pieces and still have low mesh load and avoid overlap. One configuration of the mesh pieces is to have a slightly wider top of the extension for suturing to the sacrum if the self-affixing dilator is not included. The body of the mesh may include fixation tips configured for attachment to the vagina. The narrow extension portion of the mesh graft includes a dilator configured to adjustably couple the mesh graft to the sacrum without requiring the surgeon to tie down the sutures. The dilator preferably has a suture leader at one end thereof. One object of the invention is to provide a method for treating recurring prolapse that is predictable and reproducible, thereby increasing success rates and decreasing pain, variance, recovery time, and costs. Another object of the invention is to provide a method that has one or more of the characteristics discussed above but which is relatively simple to set up and perform.

"The method of the present invention is preferably directed to a laparoscopic method of employing a mesh graft for treating and preventing recurring vaginal prolapse. Alternatively, the method of employing the mesh graft according to the present invention could be done through an incision.

"These and other aspects and objects of the present invention will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following description, while indicating preferred embodiments of the present invention, is given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the present invention without departing from the spirit thereof, and the invention includes all such modifications."

For additional information on this patent, see: Miller, Dennis. Method for Treating Prolapse and Incontinence. U.S. Patent Number 9414902, filed November 4, 2010, and published online on August 16, 2016. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9414902.PN.&OS=PN/9414902RS=PN/9414902

Keywords for this news article include: Urology, Incontinence, Gastroenterology, Risk and Prevention, Biotechnology Companies, Boston Scientific Scimed Inc..

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2016, NewsRx LLC

(c) 2016 NewsRx LLC, source Health Newsletters

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Financials ($)
Sales 2016 8 312 M
EBIT 2016 1 756 M
Net income 2016 595 M
Debt 2016 4 054 M
Yield 2016 -
P/E ratio 2016 49,25
P/E ratio 2017 24,73
EV / Sales 2016 4,41x
EV / Sales 2017 4,01x
Capitalization 32 617 M
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Number of Analysts 27
Average target price 27,3 $
Spread / Average Target 14%
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Michael F. Mahoney Chairman, President & Chief Executive Officer
Edward Mackey Executive Vice President-Operations
Daniel J. Brennan Chief Financial Officer & Executive Vice President
Keith D. Dawkins Global Chief Medical Officer & Executive VP
Nelda J. Connors Independent Director
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