Methods and apparatus for securing a urethral sling to a pubic bone
First Claim
Patent Images
1. A surgical kit comprising:
- a urethral sling having opposed sling sides and extending between a first sling end adapted to be coupled to a first pubic bone and a second sling end adapted to be coupled to a second pubic bone to fix the urethral sling in a sub-urethral location to support the urethra and alleviate incontinence, the urethral sling having or capable of having a sling opening formed through the sling adjacent the first and second sling ends;
at least one bone anchor comprising an anchor body having an anchor body axis and extending between a distal bone fixation mechanism adapted to be attached to pubic bone through an anchor neck having a neck dimension lateral to the anchor body axis to a proximal anchor head having a head dimension lateral to the anchor body axis exceeding the neck dimension, whereby the urethral sling is adapted to be applied against the anchor head to insert the anchor head through the sling opening and engage the sling with the anchor neck;
at least one sling retainer having a retainer dimension exceeding the head dimension adapted to be engaged by one of the anchor head and the anchor neck and applied against the urethral sling, the sling retainer comprising a retainer bore having a dimension smaller than the head dimension, the retainer comprising an elastic material and being capable of being stretched to pass the retainer bore over the anchor head to allow the sling retainer to be interposed between the urethral sling and the anchor head to retain the sling attached to the bone anchor; and
a sling retainer dispenser comprising;
an elongated dispenser a shaft axis and extending from a shaft proximal end to a shaft distal end, the shaft distal end engageable with the bone anchor head for axial alignment of the shaft axis with the anchor body axis; and
the at least one sling retainer supported along a length of the dispenser shaft with the retainer bore axially aligned with the shaft axis,wherein the at least one sling retainer is distally moveable along the shaft from the shaft distal end and over the bone anchor head engaged by the shaft distal end.
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Abstract
Surgical procedures, kits and implants for alleviating human incontinence, and particularly providing improved methods and apparatus to secure a urethral sling to pubic bone in a sub-urethral location to support the urethra and alleviate incontinence are disclosed. Bone anchors, e.g., bone screws, are driven into pubic bones with exposed bone anchor heads and necks configured to receive and support a urethral sling applied to the bone anchors with and without retainers applied against the urethral sling to retain portions of the urethral sling between the bone anchor heads and the pubic bones.
248 Citations
19 Claims
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1. A surgical kit comprising:
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a urethral sling having opposed sling sides and extending between a first sling end adapted to be coupled to a first pubic bone and a second sling end adapted to be coupled to a second pubic bone to fix the urethral sling in a sub-urethral location to support the urethra and alleviate incontinence, the urethral sling having or capable of having a sling opening formed through the sling adjacent the first and second sling ends; at least one bone anchor comprising an anchor body having an anchor body axis and extending between a distal bone fixation mechanism adapted to be attached to pubic bone through an anchor neck having a neck dimension lateral to the anchor body axis to a proximal anchor head having a head dimension lateral to the anchor body axis exceeding the neck dimension, whereby the urethral sling is adapted to be applied against the anchor head to insert the anchor head through the sling opening and engage the sling with the anchor neck; at least one sling retainer having a retainer dimension exceeding the head dimension adapted to be engaged by one of the anchor head and the anchor neck and applied against the urethral sling, the sling retainer comprising a retainer bore having a dimension smaller than the head dimension, the retainer comprising an elastic material and being capable of being stretched to pass the retainer bore over the anchor head to allow the sling retainer to be interposed between the urethral sling and the anchor head to retain the sling attached to the bone anchor; and a sling retainer dispenser comprising; an elongated dispenser a shaft axis and extending from a shaft proximal end to a shaft distal end, the shaft distal end engageable with the bone anchor head for axial alignment of the shaft axis with the anchor body axis; and the at least one sling retainer supported along a length of the dispenser shaft with the retainer bore axially aligned with the shaft axis, wherein the at least one sling retainer is distally moveable along the shaft from the shaft distal end and over the bone anchor head engaged by the shaft distal end. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A sling retention apparatus in combination with a sling retainer dispenser for securing a urethral sling at a plurality of locations to pubic bone to fix the urethral sling in a sub-urethral location to support the urethra and alleviate incontinence, the urethral sling having a sling opening, wherein the sling retention apparatus comprises:
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at least one bone anchor adapted to be attached to pubic bone, the at least one bone anchor comprising an anchor neck, an anchor head having a head dimension enabling passage through the sling opening, and an anchor body axis, and at least one sling retainer having a retainer dimension exceeding the head dimension and a neck receiving port, the neck receiving port having a dimension smaller than the head dimension, the retainer comprising an elastic material and being capable of being stretched to pass the receiving port over the anchor head, wherein the urethral sling is adapted to be applied against the anchor head to insert the anchor head through the sling opening and apply the sling against the anchor neck, and the sling retainer is adapted to be interposed between the sling and the anchor head with the anchor neck extending through the neck receiving port to retain the sling against the anchor neck and to inhibit passage of the sling over the anchor head; and
wherein the sling retainer dispenser comprises;an elongated dispenser shaft having a shaft axis and extending from a shaft proximal end to a shaft distal end, the shaft distal end shaped to engage the at least one anchor head for axial alignment of the shaft axis with the anchor body axis, wherein the at least one sling retainer is supported along the length of the dispenser shaft with the neck receiving ort axially aligned with the shaft axis, and wherein the at least one sling retainer is distally moveable along the dispenser shaft from the shaft distal end and over the bone anchor head engaged by the shaft distal end. - View Dependent Claims (13, 14, 15, 16, 17)
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18. A method of securing a urethral sling at a plurality of locations to pubic bone to fix the urethral sling in a sub-urethral location to support the urethra and alleviate incontinence, the urethral sling having a sling opening, the method comprising:
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providing a bone anchor having an anchor body with an anchor body axis and extending between a distal bone fixation mechanism adapted to be attached to pubic bone through an anchor neck having a neck dimension lateral to the anchor body axis to a proximal anchor head having a head dimension lateral to the anchor body axis exceeding the neck dimension, and a driver engagement element adapted to be engaged to drive the bone fixation mechanism into bone, providing a driver having a drive shaft and a driving element at a drive shaft distal end; engaging the driver engagement element with the driving element; operating the driver to drive the bone anchor into pubic bone, applying the opening of the urethral sling around the anchor neck; providing a sling retainer having a retainer dimension exceeding the head dimension and a neck receiving bore by supporting the sling retainer on a sling retainer dispenser; and after applying the opening of the urethral sling around the anchor neck, interposing the sling retainer between the sling and the anchor head with the anchor neck extending through the neck receiving bore to retain the sling against the anchor neck and to inhibit passage of the sling over the anchor head by aligning the sling retainer dispenser with the anchor head, dispensing the sling retainer from the sling retainer dispenser between the sling and the anchor head, and moving the sling retainer over the anchor head. - View Dependent Claims (19)
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Specification