WO2006034719A1

WO2006034719A1 - Vaginal stent for prevention and treatment of vaginal vault prolapse

Info

Publication number: WO2006034719A1
Application number: PCT/EG2004/000040
Authority: WO
Inventors: Sherif Mohammed Maher Ibrahim Negm; Rasha Ahmed Mostafa Kamel
Original assignee: Negm Sherif Mohammed Maher Ibr; Rasha Ahmed Mostafa Kamel
Priority date: 2004-09-28
Filing date: 2004-10-17
Publication date: 2006-04-06

Abstract

The stent is composed of an external rigid skeleton (1) shaped like an incurving rectangle made of the organically inert substance (Polypropylene). The area in the center or the inside area of the skeleton (1) is filled with a macroporous polypropylene mesh (2) (pores > 78 um). Fixed to each of the four corners of the stent is a surgical thread (3) made of Polydioxanone (PDS) number Zero (1-0) with a swaged on curved needle. The stent is of two different sizes to accommodate variations in vaginal capacity. The large measures: 9 cm in length (4), 5 cm in width (5) and 5 mm in thickness. The small measures: 7 cm in length (4), 3.5 cm in width (5) and 3.5 mm in thickness.

Description

Vaginal stent for prevention and treatment of vaginal vault prolapse

Technical Field

Vaginal vault prolapse is the descent of the upper vagina after hysterectomy. It could also be a part of congenital prolapse .Enterocoele is a subtype.

There are three degrees of vault prolapse : a minimal type where the upper third is everted , a moderate or partial type where the upper half of the vagina is everted and the vault would reach the vulva and a complete type where more than half of the vagina is everted and any part of the vagina is outside the vulva.

Background Art

The Prevention of vaginal vault prolapse after hysterectomy depends on the proper suspension of the vaginal vault to the cardinal & uterosacral ligaments. In -which case the strength of these ligaments is an effective factor.

The management of vaginal vault prolapse is by an abdominal or a vaginal approach :

Vaginally, the vault can be suspended by a suture to the sacrospinous ligament ( vaginal sacrospinous colpopexy) or alternatively the anterior and posterior vaginal walls can be sutured together effectively closing the vagina ( Colpocleisis ).

Abdominally, the vaginal vault can be suspended to the anterior wall of the periosteum of the sacrum by means of a mesh with one end sutured to the vault & the other to the periosteum of the sacrum ( Abdominal Sacro- colpopexy). Problems with prophylactic measures :

The problem with suspension of the vaginal vault to the Mackenrodt & uterosacral ligaments at the time of the vaginal surgery is that sometimes they are too weak due to obstetric trauma or postmenopausal atrophy and thus are unable to support the vault properly resulting in prolapse. Problems with curative measures :

The problem with ( vaginal sacrospinous colpopexy ) is that the operation demands great surgical skill as well as specific surgical instruments as it carries the risk of injury to the pudendal vessels and nerve as well as the rectum . Also it doesn't compensate for the weakness in the prerectal fascia which is the primary cause for the prolapse in most of the cases. Moreover this operation results in abnormal anatomical position and direction of the vagina which on its own has numerous complications . The problem with ( colpocleisis ) is that it closes the vagina thus making sexual intercourse impossible. The problem with abdominal sacrocolpopexy , whether laparoscopically or by laparotomy, is that it requires great surgical skill with the possibility of injuring the presacral blood vessels as they pass through the sacral foramina ( Foramina Mortis ) leading to severe bleeding that is impossible to control and is life threatening . Also this operation doesn't compensate for the weakness in the prerectal fascia and results in abnozrmal anatomical position and direction of the vagina. Disclosure of the Invention The vaginal stent gives a simple solution to the inadequacies of the prophylactic and curative surgeries for vaginal vault prolapse as it is placed between the anterior rectal wall and anal canal posteriorly and the posterior vaginal wall anteriorly. Its upper end is anchored with sutures to the vaginal vault and the underlying fascia while its lower end is anchored with sutures to the perineal body thus it replaces or reinforces the prerectal fascia and prevents vaginal prolapse.

The vaginal stent is composed of :

An external rigid skeleton shaped like an incurving rectangle made of the biologically inert substance Polypropylene. The area inside of the skeleton is filled with a coarse macroporous mesh

( pores >75 um ) made of Polypropylene.

Fixed to the four corners of the stent is a surgical swaged double suture made of Polydioxanone (PDS) number Zero (1-0) on a round bodied curved needle. The stent is of two different sizes to accommodate variations in vaginal capacity.

The large measures : 9 cm in length , 5 cm in width and 5mm in thickness.

The small measures : 7 cm in length , 3.5 cm in width and 3.5 mm in thickness.

Brief Description of the drawing The numbers on the diagram :

1- External skeleton made of Polypropylene.

2- Polypropylene coarse macroporous mesh ( pores > 75 um ). 3- ( PDS ) number zero suture swaged on a curved round bodied needle. 4- Length: large = 9cm , small = 7cm. 5- Width : large =5 cm, small = 3.5 cm.

Best Mode for Carrying Out the Invention

The stent is placed by vaginal surgery.The operation begins by dissecting the posterior wall of the vagina from the anterior rectal wall similar to posterior colporraphy.The dissection is carried upwards until the vaginal vault is reached and laterally the dissection is extended sufficiently to allow for the stent to be positioned. After adequate dissection the stent is put in place , positioned longitudinally in the dissected space between the vagina and the rectum. The stent is then anchored by the (PDS) sutures at its four corners .The upper ones are sutured to the vaginal vault and the underlining fascia. The lower ones are sutured to the perineal body.

Thus the. stent is placed in a fashion similar to the prerectal fascia, replacing it or reinforcing it. The vagina is then trimmed to remove any redundant tissue and is closed similar to closure of posterior colpoperineoraphy.

Industrial Applicability

The stent is not complicated in structure, therefore should be easy to manufacture. The material chosen for the stent is biologically inert.

It is not an expensive material. Also it is light which makes it tolerable for the women using it.

Claims

1 - The invention is a device called ( vaginal stent ) which is made of

Polypropylene. It represents a simple and new solution for the prevention and the treatment of vaginal vault prolapse.

2- Referring to the above claim, about the device named ( vaginal stent for the prevention and treatment of vaginal vault prolapse ) the stent is formed of a rigid skeleton made of Polypropylene shaped as an incurving rectangle. Its inside area is filled with a macroporous mesh made of the same material ( pores >75 um ). Attached to each of the four corners of the stent is a surgical swaged double suture made of Polydioxanone ( PDS ) number zero ( 1- 0 ) on a round bodied curved- needle. The vaginal stent comes in two different sizes to fit different vaginal capacities : The large stent measures 9 cm in length , 5 cm in width and 5 mm in thickness . The small stent measures 7 cm in length , 3.5 cm in width and 3.5 mm in thickness.

3- Referring to the previous claims, this stent is used to prevent and treat vaginal vault prolapse by placing it between the posterior vaginal wall anteriorly and the rectum and anal canal posteriorly where it is fixed, using the four attached sutures, in a fashion closely resembling the prerectal fascia. It is fixed in its place by suturing its upper end to the vaginal vault and the underlining fascia . Its loΛver end is sutured to the perineal body.