Transobturator surgical articles and methods

Abstract

A surgical instrument for treating incontinence includes a handle portion elongate along a handle axis and a needle portion connected to the handle portion. The needle portion has a spacer portion along the handle axis, and has a distal end. The needle portion includes a substantially helical portion that is a variable spiral portion, extending from the straight spacer portion. The variable spiral portion is sized and shaped to extend from an incision substantially adjacent the patient's obturator foramen through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus. The needle portion has a structure near the distal end that associates the instrument with an implantable material configured to treat incontinence.

1 . A surgical instrument for treating incontinence, the instrument comprising:
 a handle portion elongate along a handle axis and having a cross section orthogonal to the axis, the cross section having a width and a thickness, wherein the width is greater than the thickness; and   a needle portion connected to said handle portion, having a spacer portion along the handle axis, and having a distal end, the needle portion having a substantially helical portion extending from the spacer portion, wherein the helical portion is sized and shaped to extend from an incision substantially adjacent a patient's obturator foramen through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus;   wherein the needle portion has a structure near the distal end that associates the instrument with an implantable material configured to treat incontinence.   
     
     
         2 . The instrument of  claim 1 , wherein the helical portion has a tissue clearance depth of greater than about 1.5 inches and less than 2.5 inches. 
     
     
         3 . The instrument of  claim 1 , wherein the helical portion has a maximum width of greater than about 1.25 inches and less than about three inches. 
     
     
         4 . The instrument of  claim 1 , wherein the structure comprises an eyelet. 
     
     
         5 . The instrument of  claim 1 , wherein the distal end of the needle portion includes a distal tip situated substantially near an extension of the mid plane that is spaced from the handle portion. 
     
     
         6 . The instrument of  claim 1 , wherein the needle portion includes a substantially circular cross-sectional shape with a diameter less than about 4 mm. 
     
     
         7 - 11 . (canceled) 
     
     
         12 . The instrument of  claim 1 , wherein the needle comprises a distal
 end having a securement surface to enable a snap fit of the instrument to another surgical component used to treat the incontinence, wherein the snap fit provides the secure attachment between the instrument and the other surgical component.   
     
     
         13 . The instrument of  claim 12 , wherein the other surgical component comprises a dilator of a sling assembly configured to treat incontinence. 
     
     
         14 . The instrument of  claim 13 , wherein the instrument and the dilator have complementary engagement surfaces to resist separation of the instrument from the dilator upon being snap fit together. 
     
     
         15 - 17 . (canceled) 
     
     
         18 . A surgical assembly for treating incontinence comprising:
 a surgical instrument having a handle portion elongate along a handle axis, and having a cross section orthogonal to the axis, the cross section having a width and a thickness, wherein the width is greater than the thickness;   a needle portion connected to said handle portion, said needle portion having a distal end and having a first portion that is sized and shaped to extend between an incision substantially adjacent an obturator foramen of a patient through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus;   an implantable synthetic material; and   the needle portion having structure near the distal end to associate the surgical instrument with the implantable synthetic material.   
     
     
         19 . The surgical assembly of  claim 18 , wherein the implantable synthetic material comprises a dilator wherein the dilator has an overall length of less than about 0.7 inches. 
     
     
         20 . (canceled) 
     
     
         21 . The surgical assembly of  claim 18 , wherein the implantable synthetic material comprises a dilator with an engagement surface to connect the dilator to the surgical instrument, the dilator operatively associate with the implantable synthetic material, wherein the structure of the needle portion near the distal end that associates the surgical instrument with the implantable synthetic material includes a surface complementary with the engagement surface of the dilator. 
     
     
         22 . The surgical assembly of  claim 18 , wherein the needle portion is sized and shaped for a predetermined side of the patient, and the handle portion includes indicia indicating the predetermined side of the patient. 
     
     
         23 - 28 . (canceled) 
     
     
         29 . A surgical instrument for treating incontinence, comprising:
 a handle portion elongate along a handle axis and having a cross section orthogonal to the axis, the cross section having a width and a thickness, wherein the width is greater than the thickness   a needle extending from the handle, the needle sized and shaped to either: (a) initially extend through an incision substantially adjacent an obturator foramen of a patient and then through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus; or (b) initially extend through a region between the superior pubic ramus and the inferior pubic ramus and then through an incision substantially adjacent an obturator foramen of a patient.   
     
     
         30 - 31 . (canceled) 
     
     
         32 . The surgical instrument of  claim 29 , wherein the handle comprises
 a proximal end and a distal end with the length therebetween, the distal end connected to the needle,   two opposing sides extending between the proximal end and the distal end in the length and thickness directions,   two opposing elongate surfaces extending between the two opposing sides, in the length and width directions, and   a thumb surface at a distal end of one of the two opposing elongate surfaces.   
     
     
         33 . The surgical instrument of  claim 1 , wherein the handle comprises
 a proximal end and a distal end with the length therebetween, the distal end connected to the needle,   two opposing sides extending between the proximal end and the distal end in the length and thickness directions,   two opposing elongate surfaces extending between the two opposing sides, in the length and width directions, and   a thumb surface at a distal end of one of the two opposing elongate surfaces.   
     
     
         34 . A surgical assembly for treating incontinence, the assembly comprising
 the surgical instrument according to  claim 1 , wherein the surgical instrument is for use on a right side of the patient, and   a second surgical instrument for use on a left side of the patient, the second instrument comprising
 a second handle portion elongate along a handle axis and having a cross section orthogonal to the axis, the cross section having a width and a thickness, wherein the width is greater than the thickness; and 
 a second needle portion connected to said second handle portion, having a spacer portion along the handle axis, and having a distal end, the second needle portion having a substantially helical portion extending from the spacer portion, wherein the helical portion is sized and shaped to extend from an incision substantially adjacent the patient's obturator foramen through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus, 
   wherein the needle portion has a structure near the distal end that associates the instrument with an implantable material configured to treat incontinence.   
     
     
         35 . The surgical assembly according to  claim 18 , further comprising a second surgical instrument, the second surgical instrument having a second handle portion elongate along a handle axis, and having a cross section orthogonal to the axis, the cross section having a width and a thickness, wherein the width is greater than the thickness; and
 a second needle portion connected to said second handle portion, said second needle portion having a distal end and having a first portion that is sized and shaped to extend between an incision substantially adjacent an obturator foramen of a patient through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus,   wherein the surgical instrument is configured for use on a side of the patient, and the second surgical instrument is configured for use on an opposing side of the patient.   
     
     
         36 . The surgical assembly of  claim 18 , wherein the implantable synthetic material is sized and shaped to extend from the obturator foramen, under a midurethra, and to an opposing obturator foramen to support a urethra. 
     
     
         37 . The surgical assembly of  claim 34  further comprising an implantable material is sized and shaped to extend from the obturator foramen, under a midurethra, and to an opposing obturator foramen to support a urethra.