Method and apparatus for correction of urinary and gynecological pathologies, including treatment of incontinence cystocele
View Patent ↗Surgical articles, implants and components suitable for female pelvic health procedures are described.
1. A surgical kit comprising an insertion tool and an implant for addressing incontinence and cystocele disorders, the implant comprising:
a cystocele repair portion adapted to be secured in the patient's vaginal region, comprising a major portion that is sized and shaped to afford repair of a cystocele without lifting the patient's bladder and without placing tension on the bladder, the major portion including a urethral support portion capable of being placed underneath the patient's urethra;
a first posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region toward a first incision in the patient's buttocks that is lateral to the patient's anus;
a second posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region, on a side of the patient's anus different than that of the first posterior securement appendage, toward a second incision in the patient's buttocks that is on a side of the patient's anus opposite the first incision;
a first sling appendage for securement on a first side of the patient's urethra; and
a second sling appendage for securement on a side of the patient's urethra generally opposite the first side of the urethra;
wherein one or more of the first posterior securement appendage, the second posterior securement appendage, the first sling appendage, and the second sling appendage, includes a connector configured to engage a distal end of an insertion needle;
the insertion tool comprising a proximal end and a distal end, a handle at the proximal end, and the distal end being configured to engage the connector; and
wherein the mesh material comprises bulk knitted polypropylene monofilaments, and bulk material from which the mesh is supplied has at least a Longitudinal Elongation Factor (LEF) of 0.06 under a ½ pound load.
2. A surgical kit comprising an insertion tool and an implant for addressing incontinence and cystocele disorders, the implant comprising:
a cystocele repair portion adapted to be secured in the patient's vaginal region,
a first posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region toward a first incision in the patient's buttocks that is lateral to the patient's anus;
a second posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region, on a side of the patient's anus different than that of the first posterior securement appendage, toward a second incision in the patient's buttocks that is on a side of the patient's anus opposite the first incision;
the implant including a urethral support portion capable of being placed underneath the patient's urethra;
a first sling appendage for securement on a first side of the patient's urethra; and
a second sling appendage for securement on a side of the patient's urethra generally opposite the first side of the urethra;
wherein one or more of the first posterior securement appendage, the second posterior securement appendage, the first sling appendage, and the second sling appendage, includes a connector configured to engage a distal end of an insertion needle;
the insertion tool comprising a proximal end and a distal end, a handle at the proximal end, and the distal end being configured to engage the connector; and
wherein bulk material from which the mesh is supplied has at least a Longitudinal Elongation Factor (LEF) of more than about 0.08 under a ½ pound load.
3. A surgical implant according to claim 2 wherein bulk material from which the mesh is supplied has at least a Longitudinal Elongation Factor (LEF) of more than about 0.15 under a ½ pound load.
4. A surgical kit comprising an insertion tool and an implant for addressing incontinence and cystocele disorders, the implant comprising:
a cystocele repair portion adapted to be secured in the patient's vaginal region;
a first posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region toward a first incision in the patient's buttocks that is lateral to the patient's anus;
a second posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region, on a side of the patient's anus different than that of the first posterior securement appendage, toward a second incision in the patient's buttocks that is on a side of the patient's anus opposite the first incision;
the implant including a urethral support portion capable of being placed underneath the patient's urethra;
a first sling appendage for securement on a first side of the patient's urethra; and
a second sling appendage for securement on a side of the patient's urethra generally opposite the first side of the urethra;
wherein one or more of the first posterior securement appendage, the second posterior securement appendage, the first sling appendage, and the second sling appendage, includes a connector configured to engage a distal end of an insertion needle;
the insertion tool comprising a proximal end and a distal end, a handle at the proximal end, and the distal end being configured to engage the connector;
bulk material from which the mesh is supplied has at least a Longitudinal Elongation Factor (LEF) of at least 0.06 under a ½ pound load; and
bulk material from which the mesh is supplied has a Longitudinal Elongation Factor (LEF) of more than about 0.08 under a 1 pound load.
5. A surgical implant according to claim 4 wherein bulk material from which the mesh is supplied has a Longitudinal Elongation Factor (LEF) of more than about 0.1 under a 1 pound load.
6. A surgical implant according to claim 5 wherein bulk material from which the mesh is supplied has a Longitudinal Elongation Factor (LEF) of more than about 0.2 under a 1 pound load.
7. A surgical kit comprising an insertion tool and an implant for addressing incontinence and cystocele disorders, the implant comprising:
a cystocele repair portion adapted to be secured in the patient's vaginal region;
a first posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region toward a first incision in the patient's buttocks that is lateral to the patient's anus;
a second posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region, on a side of the patient's anus different than that of the first posterior securement appendage, toward a second incision in the patient's buttocks that is on a side of the patient's anus opposite the first incision;
the implant including a urethral support portion capable of being placed underneath the patient's urethra;
a first sling appendage for securement on a first side of the patient's urethra; and
a second sling appendage for securement on a side of the patient's urethra generally opposite the first side of the urethra;
wherein one or more of the first posterior securement appendage, the second posterior securement appendage, the first sling appendage, and the second sling appendage, includes a connector configured to engage a distal end of an insertion needle;
the insertion tool comprising a proximal end and a distal end, a handle at the proximal end, the distal end being configured to engage the connector; and
wherein the connector is a dilating connector.
8. A surgical kit comprising an insertion tool and an assembly for addressing a female patient's pelvic health disorder, the assembly comprising:
a portion adapted to be secured in the patient's vaginal region;
a first posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region toward a first incision in the patient's buttocks that is lateral to the patient's anus;
a second posterior securement appendage that is sized, shaped and configured to extend from the patient's vaginal region, on a side of the patient's anus different than that of the first posterior securement appendage, toward a second incision in the patient's buttocks that is on a side of the patient's anus opposite the first incision;
the first and second posterior securement appendages including a connector for associating the first and second posterior securement appendages with a distal end of an insertion needle; and
the insertion tool comprising a handle and a needle, the needle comprising a proximal end extending from the handle and a distal end configured to engage a connector;
wherein the connector is a dilating connector.