Device for the surgical treatment of female prolapse

Abstract

A device having a reticular or laminar structure to be surgically implanted in uro-gynaecological treatments, useful in particular for the surgical treatment of total or partial prolapse of the female pelvic organs or of prolapse of the vaginal vault.

1 - 30 . (canceled) 
     
     
         31 . An implantable device made of soft sheet material with a reticular structure insertable by vaginal surgery into a female pelvis for supporting female pelvic organs, comprising:
 (a) a central body having opposite anterior and posterior portions having anterior and posterior terminal edges respectively, and having opposite sides each with a terminal side edge, about a central longitudinal axis, said sides defining between them a width the maximum dimension of which is designated W,   (b) a pair of anterior arms extending symmetrically outward from said anterior portion transversely of said central vertical axis, said anterior arms having terminal ends spaced apart from each other a distance greater than W, and   (c) a pair of posterior arms extending symmetrically downward from said central body and diverging from each other and having terminal ends spaced apart from each other a distance greater than W.   
     
     
         32 . A device according to  claim 31  wherein said anterior arms extend generally coaxially. 
     
     
         33 . A device according to  claim 31  wherein said anterior arms extend generally perpendicularly to said central longitudinal axis. 
     
     
         34 . A device according to  claim 31  wherein each of said arms is elongated about an arm central axis, and each of said arms has a proximal portion adjacent said central body and a distal portion, and for each of said arms its proximal portion has breadth greater than the breadth of its distal portion. 
     
     
         35 . A device according to  claim 34  wherein each of said anterior and posterior arms is tapered along its length to have a smaller distal portion than its proximal portion. 
     
     
         36 . A device according to  claim 31  wherein said sheet material with a reticular structure has extending transversely through it holes having diameter in the range of 1 to 7 mm and spaced apart from each other a distance in the range of 0.05 to 0.10 cm. 
     
     
         37 . The device according to  claim 36 , wherein said material with a reticular structure is selected from the group consisting of materials of organic origin and materials of a synthetic nature. 
     
     
         38 . The device according to  claim 37 , wherein said material with a reticular structure is selected from the group consisting of membrane of bovine pericardium, human fascia lata, a cellular matrix of pig collagen and submucosa of pig's small intestine. 
     
     
         39 . The device according to  claim 38 , wherein material with a reticular structure comprises said membrane of bovine pericardium that is treated with glutaraldehyde and heparin. 
     
     
         40 . The device according to  claim 37 , wherein said material is a synthetic based on single-filament polypropylene. 
     
     
         41 . The device according to  claim 37 , wherein said material is of synthetic mixture of polypropylene and polyglactin. 
     
     
         42 . The device according to  claim 31 , wherein said central body has a generally trapezoidal shape with small and large bases generally parallel to each other, two opposite side edges, said central body comprising a anterior portion with a anterior edge that is said small base and a posterior portion with a posterior edge that is said large base,
 a pair of anterior arms extending symmetrically and generally coaxially outward from said anterior portion,   a pair of posterior arms extending symmetrically and downward from said central body's posterior portion and diverging from each other.   
     
     
         43 . The device according to  claim 42 , suitable for a female hysterectomized patient suffering a total prolapse, wherein,
 a) said anterior arms have opposite ends that are spaced apart from each other a distance designated a-a between 8 and 15 cm.,   b) said smaller base has length designated b-b between 2.5 and 6 cm.,   c) said device has total length designated d-z between 11 and 15 cm.,   d) said larger base has length designated h-h between 1.5 and 7 cm.,   e) said posterior arms have opposite ends spaced apart from each a distance designated i-i, between 4.5 and 10.5 cm;   f) said posterior arms has length designated h-I, between 2.5 and 6.5 cm.   
     
     
         44 . The device according to  claim 42 , suitable for a female non-hysterectomized patient suffering a partial prolapse, wherein,
 a) said anterior arms have opposite ends that are spaced apart from each other a distance designated a-a between 8 and 15 cm.,   b) said smaller base has length designated b-b between 2.5 and 6 cm.,   c) said device has total length designated d-z between 4 and 8 cm.,   d) said larger base has length designated h-h between 1.5 and 7 cm.,   e) said posterior arms have opposite ends spaced apart from each a distance designated i-i, between 4.5 and 10.5 cm;   f) said posterior arms has length designated h-I, between 1 and 3 cm.   
     
     
         45 . A method for surgically implanting the device according to  claim 31  in a female patient suffering a partial or total prolapse of pelvic organs into the vagina, comprising inserting the said device into the vaginal cavity of the patient by means vaginal surgery. 
     
     
         46 . A method for surgically implanting a device according to  claim 31  in a female hysterectomized patient suffering a total prolapse of pelvic organs into the vagina, comprising:
 (a) making two incisions, one in the anterior vaginal wall and one in the posterior vagina wall, 
 (b) bilaterally opening the pubo-cervical fascia, 
 (c) through the opening reaching the tendinous arch of the levator ani, 
 (d) inserting said anterior portion of said device through the vaginal cavity and positioning said anterior portion under the patient's bladder, 
 (e) fixing by stitches or staples the two anterior arms of said anterior portion of said device to the right and left tendinous arches, and 
 (f) positioning the posterior portion of the device under the intestine, 
 (g) bilaterally fixing by stitches or staples the posterior arms of said device to the right and left sacrospinous ligaments respectively. 
 
     
     
         47 . A method for surgically implanting a device according to  claim 31  in a female hysterectomized patient suffering a partial or total prolapse of pelvic organs into the vagina, comprising:
 (a) making two incisions, one in the anterior vaginal wall and one in the posterior vaginal wall, 
 (b) bilaterally fixing by stitches or staples the posterior arms of said device to the right and left sacrospinous ligaments respectively, 
 (c) positioning the posterior portion of the device under the intestine, 
 (d) bilaterally opening the pubo-cervical fascia, 
 (g) through the opening reaching the tendinous arch of the levator ani, 
 (h) inserting the anterior portion of the device through the vaginal cavity and positioning it under the bladder, and 
 (i) fixing by stitches or staples the two anterior arms of the said device respectively to the right and to the left tendinous arches. 
 
     
     
         48 . A method for surgically implanting a device according to  claim 31  in a female non-hysterectomized patient suffering a partial prolapse of pelvic organs into the vagina, comprising:
 (a) making two incisions, one in the anterior vaginal wall and one in the posterior vagina wall, 
 (b) bilaterally opening the pubo-cervical fascia, 
 (c) through the opening reaching the tendinous arch of the levator ani, 
 (d) inserting said anterior portion of said device through the vaginal cavity and positioning said anterior portion under the patient's bladder, 
 (e) fixing by stitches or staples the two anterior arms of said anterior portion of said device to the right and left tendinous arches, and 
 (f) bilaterally fixing by stitches or staples the posterior arms of said device to the right and left of the neck of the uterus.