SURGICAL METHOD AND DEVICE FOR TREATING URINARY

INCONTINENCE

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority under 35 U.S.C. § 119(e) to U.S.

Provisional Application No. 60/704,052, filed on July 29, 2005, entitled SURGICAL METHOD AND DEVICE FOR TREATING URINARY INCONTINENCE; the disclosure of which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

[0002] The present invention relates to a method and device for treating urinary incontinence. More specifically, the invention relates to a substantially noninvasive, tension- free sling technique used in such treatment. Description of the Related Art

[0003] Urinary incontinence is a condition that causes the afflicted to uncontrollably leak urine. This condition affects millions of Americans of all ages, but is more common in the elderly and in women. The condition negatively affects the quality of life of those afflicted by the condition because it can limit their activities, cause embarrassment and loss of self-esteem, and in extreme cases cause reliance on caregivers.

[0004] Urine is waste and water removed from the blood by the kidneys. Urine flows from the kidneys downward through a pair of tubes (the ureters) to the bladder. The bladder is a balloon-like container that stores urine. Urine leaves the body through another tube (the urethra) at the bottom of the bladder. Urination is controlled by muscles, called sphincters, located at the base of the bladder and in the wall of the urethra. These sphincters normally stop the flow of urine by closing off the neck of the bladder and the urethra. When the sphincters relax, they open the passage for urine. At the same time, the muscle of the bladder wall contracts (squeezes) and forces the urine out of the bladder. When you are finished urinating, the sphincters contract, and the bladder itself stops squeezing and relaxes.

[0005] Incontinence is classified by the symptoms or circumstances occurring at the time of the urine leakage. Stress incontinence may be due to poor bladder support by the pelvic muscles or to a weak or damaged sphincter. This condition allows urine to leak when the afflicted person does anything that strains or stresses the abdomen, such as coughing, sneezing, laughing, or even walking. Urge incontinence results when an overactive bladder contracts without the afflicted person wanting it to do so. Mixed incontinence is a combination of both stress and urge incontinence. Overflow incontinence occurs when the bladder is allowed to become so full that it simply overflows. This happens when bladder weakness or a blocked urethra prevents normal emptying. Environmental incontinence (sometimes called functional incontinence) occurs when people cannot get to the toilet or get a bedpan when they need it.

[0006] Stress incontinence is a particular problem for women and it is frequently treated by surgery. A common surgical method of treatment is a sling procedure. These surgeries generally involve methods of supporting either the neck of the bladder or the urethra. Sling procedures can be tension or tension free and can be done through the abdomen or through the vagina. Early methods utilized the patients own tissue (e.g., fascia lata), fascia and dermal tissue from cadavers, and tissue from non-human animals (e.g., porcine dermis). Most of the more recently developed techniques utilize a synthetic material, for example polyethylene and polypropylene.

[0007] Various methods of sling procedures are known in the art. Many modern techniques utilize a synthetic mesh as the sling material. This mesh can be made of various synthetic materials, but is primarily made of polypropylene. Various commercial versions of this mesh exist and are known to those of skill in the art.

[0008] One existing technique is the tension-free vaginal tape (TVT) procedure. The TVT method employs a synthetic mesh, generally polypropylene, to support the bladder or urethra. A surgeon can carry out the procedure through the abdomen or through the vagina.

[0009] In the TVT abdominal technique, the surgeon first makes a 1.5 to 2 cm incision in the vaginal epithelium over the mid-urethra. The surgeon then dissects channels which are sufficiently large to allow passage of the surgeon's finger. The dissected channels

are under the vaginal epithelium and toward the descending pubic rami. The surgeon then makes a small incision on either side of the patient's midline slightly above the symphysis pubis. The surgeon inserts a narrow needle through the midline incision and passes it under the descending pubic ramus until it touches the surgeon's finger inserted in the vagina. The surgeon uses his finger to guide the needle to the vaginal incision. The surgeon attaches the synthetic mesh to the needle and pulls it back through the midline incision. The surgeon adjusts the tension of the sling and removes the sheath from the tape. A second incision is made on the opposite side of the patient's midline and the surgeon repeats the above steps. The surgeon cuts the mesh extending out of the midline incisions so that it is flush with the patient's skin.

[0010] In the TVT vaginal technique, the surgeon makes a mid-urethral incision in the vagina. The surgeon next uses scissors to make channels on either side of the incision that extend toward the descending pubic rami. The needle passing device with the mesh attached to its distal end is inserted through the vaginal incision and into one of the two channels. The needle is then pushed toward the ipsilateral shoulder and firmly into the underside of the descending pubic ramus guided by the surgeon's finger in the vaginal incision. The needle is then used to penetrate the endopelvic fascia, abdominal wall fascia, and then the abdominal skin. After the needle penetrates the skin, the mesh that is attached to the needle is cut and the needle is removed leaving the mesh in place. The process is repeated for the opposite side of the patient. The surgeon adjusts the tension and closes the incisions.

[0011] Another example of a sling procedure is the transobturator tape (TOT) procedure. The TOT procedure is also a tension-free sling technique and also utilizes a synthetic mesh to support the bladder or urethra, hi the TOT technique, the surgeon makes an incision in the vaginal epithelium over the mid-urethra. The surgeon dissects a channel sufficiently large to allow passage of a finger to the underside of the iscliiopubic ramus by using both sharp and blunt dissection of tissue. The surgeon makes an incision at the genitofemoral fold between the labium majoris and the thigh. The surgeon places his index finger in the vaginal channel and inserts a narrow introducer needle through the incision at the genitofemoral fold. The surgeon uses the needle to penetrate the obturator membrane and

muscle and then rotates the needle under the pubic ramus. The surgeon guides the needle to the vaginal incision through, the channel created in the vagina with his index finger. The synthetic mesh tape is drawn through the vaginal incision until it penetrates the skin at the genitofemoral incision. The excess tape is cut at both incisions. The surgeon makes another incision at the genitofemoral fold on the opposite side of the initial incision and the process is repeated.

[0012] The TVT and TOT techniques, along with other techniques, are described in detail in Alfred E. Bent, "Sling and Bulking Agent Placement Procedures," Rev. Urol. 2004, 6(Suppl. 5). Importantly, both methods, along with other previously known methods, rely on vaginal dissection to pass the tape in the vagina. In addition, the known methods utilize small, narrow needles to pass the tape through the incisions and channels made during the procedure.

[0013] All existing techniques involve vaginal dissection using scissors or other sharp instruments to create a vaginal channel on both sides of the midline between the incision in the vaginal wall and undersurface of the pubic rami. These vaginal channels are wide enough to allow the introduction of the surgeon's finger in the channel to guide the needle between the pubuc rami and the incision in the vaginal mucosa.

SUMMARY OF THE INVENTION

[0014] The present invention provides noninvasive techniques for treating urinary incontinence. Novel instruments that are particularly adapted and useful for the techniques are also encompassed within this invention. The techniques and instruments are described below.

[0015] One embodiment of the present invention is a surgical method for treating female urinary incontinence, which includes the steps of: puncturing the vaginal wall over the mid-urethra; creating a tunnel on both sides of the patient's midline between the vaginal wall and the urethra by separating layers of tissue, wherein said tunnel is sized to receive a supporting material; puncturing the skin of the patient near the genitofemoral fold; advancing a needle through the puncture, the obturator fossa and through said tunnel until the tip of the needle exits through the puncture in the vaginal wall; attaching a support material to said needle; retracting said needle until it exits through the puncture in the skin; repeating the

puncturing, advancing, attaching and retracting steps on the other side of the patient's midline; and adjusting the tension of the support material to achieve continence in the patient. In some embodiments, creating a tunnel is done by first creating a narrow tunnel and then increasing the size of the tunnel until it is sized to receive a supporting material, hi some embodiments the increasing of the size of the tunnel is done by using sequentially larger tunneling instruments, hi some embodiments, the smallest tunneling instrument is about 1.5 mm wide, a first larger tunneling instrument is about 2.5 mm wide, a second larger tunneling instrument is about 5 mm wide, a third larger tunneling instrument is about 7.5 mm wide, and a fourth tunneling instrument is about 10 mm wide, hi some embodiments the support material is a synthetic mesh, hi some embodiments the guide/tunneler instrument is inserted into the created tunnel prior to puncturing the skin of the patient near the genitofemoral fold. In some embodiments, the guide/tunneler instrument remains in the tunnel until the needle exits through the puncture in the vaginal wall.

[0016] Another embodiment of the present invention is a surgical method for treating female urinary incontinence, that includes the steps of: puncturing the skin of the patient near the genitofemoral fold; creating a tunnel between the vaginal wall and the urethra by separating layers of tissue, wherein the separating layers of tissue occurs as a wide-tipped needle is advanced through the puncture and the obturator fossa, and wherein said tunnel is sized to receive a supporting material; attaching a support material to said needle; retracting said needle until it exits through the puncture in the skin; repeating the creating a tunnel, attaching, and retracting steps on the other side of the patient's midline; and adjusting the tension of the support material to achieve continence in the patient.

[0017] Another embodiment of the present invention is a surgical method for treating female urinary incontinence that includes the steps of: puncturing the skin of the patient near the genitofemoral fold; creating a tunnel between the vaginal wall and the urethra by separating layers of tissue, wherein the separating layers of tissue occurs as a wide-tipped needle is advanced through the puncture and the obturator fossa, and wherein said tunnel is sized to receive a supporting material; attaching a support material to said needle; retracting said needle until it exits through the puncture in the skin; repeating the creating a tunnel,

attaching, and retracting steps on the other side of the patient's midline; and adjusting the tension of the support material to achieve continence in the patient.

[0018] Another embodiment of the present invention is a surgical method for treating female urinary incontinence that includes the steps of: puncturing the skin of the patient near the genitofemoral fold; creating a tunnel between the vaginal wall and the urethra by separating layers of tissue, wherein the separating layers of tissue occurs as a wide-tipped needle is advanced through the puncture and the obturator fossa, and wherein said tunnel is sized to receive a supporting material; attaching a support material to said needle; retracting said needle until it exits through the puncture in the skin; repeating the creating a tunnel, attaching, and retracting steps on the other side of the patient's midline; and adjusting the tension of the support material to achieve continence in the patient.

[0019] Another embodiment of the present invention is a surgical method for treating female urinary incontinence that includes the steps of: puncturing the anterior vaginal wall in the midline over the bladder neck, proximal or mid-urethra; creating a runnel between the vaginal wall and the urethra by separating layers of tissue, wherein the separating layers of tissue occurs as a wide-tipped needle is advanced through the puncture and the obturator fossa, and wherein said tunnel is sized to receive a supporting material; advancing said wide- tipped needle until it punctures the skin of the patient near the genitofemoral fold; attaching a support material to said needle; retracting said needle until it exits through the puncture in the anterior vaginal wall; repeating the creating a tunnel, attaching, and retracting steps on the other side of the patient's midline; and adjusting the tension of the support material to achieve continence in the patient.

[0020] Another embodiment of the present invention is a surgical method for treating female urinary incontinence that includes the steps of: puncturing the anterior vaginal wall in the midline over the bladder neck, proximal or mid-urethra; creating a tunnel between the vaginal wall and the urethra by separating layers of tissue, wherein said tunnel is sized to receive a supporting material; puncturing the skin of the patient near the genitofemoral fold; attaching a support material to a needle and inserting a needle into said tunnel; advancing said needle until it exits through the puncture in the skin of the patient; repeating the creating a runnel, puncturing, attaching and advancing steps on the other side of the patient's midline;

and adjusting the tension of the support material to achieve continence in the patient, hi some embodiments, the tunnel is created by first creating a narrow tunnel and then increasing the size of the tunnel until it is sized to receive a supporting material, hi some embodiments, the size of the tunnel is increased by using sequentially larger tunneling instruments. In some embodiments, the smallest tunneling instrument is about 1.5 mm wide, a first larger tunneling instrument is about 2.5 mm wide, a second larger tunneling instrument is about 5 mm wide, a third larger tunneling instrument is about 7.5 mm wide, and a fourth tunneling instrument is about 10 mm wide, hi some embodiments the support material is a synthetic mesh.

[0021] Another embodiment of the present invention is a surgical method for treating female miliary incontinence that includes the steps of: puncturing the skin of the patient in the supra-pubic region; creating a tunnel between the vaginal wall and the urethra by separating layers of tissue, wherein the separating layers of tissue occurs as a wide-tipped needle is advanced through the puncture, lateral to the midline and through the retropubic space behind the pubic bone and the medial margins of the eiidopelvic fascia, and wherein said tunnel is sized to receive a supporting material; puncturing the vaginal wall in the midline over the mid-urethra, proximal urethra, bladder neck, or anywhere in between those landmarks; attaching a support material to a needle; retracting said needle until it exits through the puncture in the skin of the patient; repeating the puncturing the skin, creating the tunnel, attaching, and retracting steps on the other side of the patient's midline; and adjusting the tension of the support material to achieve continence in the patient.

[0022] Another embodiment of the present invention is a surgical method for treating female urinary incontinence that includes the steps of: attaching a support material to a wide-tipped needle; puncturing the anterior vaginal wall in the midline over the bladder neck, proximal or mid-urethra; creating a tunnel between the vaginal wall and the urethra by separating layers of tissue, wherein the separating layers of tissue occurs as said wide-tipped needle is advanced through the puncture and lateral to the midline and through the retropubic space behind the pubic bone and the medial margins of the endopelvic fascia, and wherein said tunnel is sized to receive a supporting material; puncturing the skin of the patient in the supra-pubic region with said wide-tipped needle; repeating the creating a tunnel and

puncturing steps on the other side of the patient's midline; and adjusting the tension of the support material to achieve continence in the patient. <

[0023] The present invention also relates to novel instruments and instrument kits that can be used in the novel tension-free sling techniques described herein or in performing other surgical procedure similar techniques. Some embodiments of the instruments of the present invention can tunnel through tissue by pushing layers of tissue apart, rather than cutting or dissecting tissue. Some embodiments of the instruments of the present invention can create a tunnel just large enough to allow the sling material to pass through tissue and be placed in position to provide the needed support. Some embodiments of the instruments of the present invention are wide-tipped needles that can puncture a patient's skin and create the channel through which the support material will be placed, hi some embodiments the needle is curved. Some embodiments of the instruments of the present invention are tunneling or tunneling/guide instruments. Generally, these embodiments tunnel through tissue by pushing layers of tissue aside, rather than cutting or dissecting tissue.

[0024] Another embodiment of the present invention is a surgical tool kit comprising the novel instruments of the present invention, hi one embodiment, the tool kit includes a tunneling/guide instrument, wherein said tunneling guide instrument is substantially straight along its longest axis, has a generally concave surface, and a sharp, pointed tip; and a plurality of tunneling instruments, wherein each of said tunneling instruments is substantially straight along its longest axis, has a generally flat surface, and a sharp, pointed tip; and wherein each of said tunneling instruments has a different width, hi some embodiments the kit includes two tunneling instruments. In some embodiments the kit includes three tunneling instruments, hi some embodiments the kit includes four tunneling instruments, hi some embodiments the kit includes five tunneling instruments, hi some embodiments, the kit includes a tunneling/guide instrument that has a width of about 5 mm to about 15 mm and a tunneling instrument having a width of about 1.5 mm, a tunneling instrument having a width of about 2.5 mm, a tunneling instrument having a width of about 5 mm, a tunneling instrument having a width of about 7.5 mm, and a tunneling instrument having a width of about 10 mm. hi some embodiments the tool kit also includes a needle that has a sharp tip that has a width of about 20 mm to about 150 mm and a structure capable of

attaching a support material. In some embodiments the surgical tool kit includes a needle, that has a sharp tip that has a width of about 20 mm to about 150 mm and a structure capable of attaching a support material; and a plurality of tunneling instruments, wherein each of said tunneling instruments is substantially straight along its longest edges, a generally flat surface, and a pointed, sharp tip; and wherein each of said tunneling instruments has a different width.

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIGURES IA and IB are schematic views of an embodiment of the tunneler and/or tunneler/guide instruments of the invention.

[0026] FIGURE 2A is another schematic view of an embodiment of the tunneler and/or tunneler guide instruments of the invention.

[0027] FIGURE 2B is blow-up view of an embodiment of the gripping surface an on embodiment of the tunneler and/or tunneler/guide instruments of the invention.

[0028] FIGURES 3A-F show a schematic view of an embodiment of the tunneler/guide instrument and an embodiment of the tunneler instruments of the present invention (in various sizes).

[0029] FIGURES 4A and 4B show schematic views of an embodiment of the tunneler/guide instrument of the present invention.

[0030] FIGURES 5-9 show schematic views of an embodiment of the tunneler instruments of the present invention in 4 different widths.

[0031] FIGURES 10-13 demonstrate various steps of an embodiment of the surgical method of the invention, hi particular, the figures depict the method utilizing an embodiment of the curved needle of the invention.

[0032] FIGURE 14 shows the use of an embodiment of the tunneling instrument of the invention in creating a tunnel from the patient's sub-mucosal plane between the anterior vaginal wall and the urethra.

[0033] FIGURE 15 shows the use of an embodiment of an embodiment of the curved needle of the invention in another embodiment of the method of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Surgical Instruments

[0034] The present invention also relates to novel instruments and tool kits including these instruments, that can be used in the novel tension-free sling techniques described herein or in performing other surgical procedure similar techniques. Embodiments of these instruments are generally characterized by their ability to tunnel through tissue by pushing layers of tissue apart, rather than cutting or dissecting tissue. Embodiments of the instruments are also generally characterized by their ability to create a tunnel just large enough to allow the support material to pass through tissue and be placed in position to provide the needed support.

[0035] One instrument is a needle that can be used to puncture the patient's skin and to create the channel through which the sling will be placed. The needle of the present invention differs in certain substantial aspects from those known in the art. The needle of the present invention has a wide, sharp tip. In some embodiments the tip is from about 20 mm to about 150 mm wide. Preferably, the tip is at least about 1 cm wide. The tip must be sharp enough to puncture a patient's skin. This wide, sharp tip enables the needle to puncture the skin and create a channel in the skin by pushing layers of tissue aside. Importantly, this permits performance of the surgical method without cutting or dissecting the tissue. The needle is also able to attach to the support material (because it has an eyelet, clamp, or other structure capable of attaching the support material) and pull it through the created channel. The needle does so in a way that aids the sling material in lying flat against the tissue. The needle may also be curved in such a manner to facilitate its use in the novel procedures described herein.

[0036] The present invention also encompasses other surgical instruments. Examples of embodiments of the surgical instruments of the present invention are depicted in Figures 1-9. hi the context of the procedures of the present invention, these instruments are used to create a channel in which the sling material will be placed. Generally, these instruments tunnel through tissue by pushing layers of tissue aside, rather than cutting or dissecting tissue. Embodiments of the instruments are also useful in that they can create a channel just big enough for the support material to be inserted. Embodiments create a channel that facilitates the sling material lying fiat against the tissue.

[0037] An embodiment of an instrument of the present invention is depicted in Figures 1-3. This embodiment has distal portion 100 and proximal portion 200. hi this embodiment distal portion 100 is the portion that enters the patient and proximal portion 200 is the portion used by the surgeon to grip and manipulate the instrument. Preferably, the proximal portion 200 is sized and shaped for comfortable and effective handling by the surgeon. More preferably, the proximal portion 200 is shaped as depicted in Figures 1-3. Preferably, the proximal portion 200 has a width 202 of about 2 cm to about 4 cm, a length 203 of about 2 cm to about 5 cm, and a thickness of about .25 cm to about 1 cm. The proximal portion 200 preferably has a gripping surface 201 to aid handling by the surgeon. One embodiment of gripping surface 201 is depicted in detail in Figure 3. Gripping surface 201 preferably has bumps or texture to enhance the grip of the surgeon on the device. Gripping surface 201 can be on one or both sides of the proximal portion 200 of the instrument and can cover all or part of surface 204. Preferably, gripping surface 201 covers only part of surface 204. hi other embodiments gripping surface 201 is a depression sized to aid handling by the surgeon, hi yet other embodiments, the proximal portion 200 does not have a gripping surface. Distal portion 100 can be configured in various ways, for example, as depicted in Figures 3-9. hi the particular embodiment depicted, proximal portion 100 comprises an embodiment of the tunneling/guide instrument of the present invention, such as that depicted in Figures 3F and 4.

[0038] In other embodiments, the instruments of the present invention do not have a specialized proximal portion for use in manipulating the instrument, hi such embodiments, the instruments would essentially be as depicted in Figures 4-9. In such embodiments, the instruments may have a greater length 106 or 306 (e.g., an additional 1-5 cms) to compensate for the lack of a proximal portion.

[0039] Figure 4 depicts an embodiment of the tunneling/guide instrument of the present invention. Preferably, this instrument is straight or substantially straight along its longest edges 101 and 104, and has a generally concave surface 102. Preferably, the distal portion of this embodiment has a length 106 of about 5 cm to about 15 cm — most preferably about 12.5 cm. Preferably, this embodiment has a width 105 of about 5 to about 15 mm. Preferably, this embodiment has a tapered tip 103, wherein width 105 decreases.

[0040] Figures 6-9 depict an embodiment (in different sizes) of the tunneling instruments of the present invention. Preferably the instruments are straight or substantially straight along its longest edges 304 and 307 and have a length 306 of about 5 cm to about 15 cm. hi the currently most preferred embodiment, the instruments have a length 306 of about 12.5 cm. Preferably, the instruments have a width 301 of about 1 mm to about 15 mm and a thickness 305 of about 1 to about 2 mm. Preferably, the instruments have a flat or substantially flat surface 300 on both sides of the instrument. Preferably the instruments have a tapered tip 302, wherein width 301 and thickness 305 decrease resulting in a wedge-like structure, hi some embodiments tapered tip 302 only decreases thickness 305.

[0041] Also encompassed within the present invention is a kit that includes a plurality of the surgical instruments of the present invention. Preferably, the kit includes a tunneling/guide instrument such as that depicted in Figures 1, 2, 3F, and 4, and a plurality of tunneling instruments (such as those in Figures 3A-3E and Figures 5-9) having varying widths, hi some embodiments, the ldt includes a tunneling/guide instrument and two tunneling instruments, each having a different width, hi some embodiments, the kit would include a tunneling/guide instrument and three tunneling instruments, each having a different width. In some embodiments, the kit includes a tunneling/guide instrument and four tunneling instruments, each having a different width, hi some embodiments, the kit includes a tunneling/guide instrument and five tunneling instruments, each having a different width. Most preferably, the kit includes a tunneling/guide instrument having a width of about 5 mm to about 15 mm and four tunneling instruments having widths of about 1.5 mm, about 2.5 mm, about 5 mm, about 7.5 mm, and about 10 mm. The kit may also include (in lieu of, or in addition to, the tunneling/guide instrument) a needle having a wide, sharp tip and a structure for attaching to the support material. Of course, various combinations of tunneling instruments of different widths and/or different embodiments may be included in the kits of the present invention.

[0042] The instruments and kits described herein are useful in the novel surgical procedures of the present invention. The instruments and ldts are also useful in other similar procedures or any surgical procedure that requires tunneling through tissue. Surgical Techniques

[0043] The present invention also relates to novel tension-free sling techniques for use in treating urinary incontinence. These methods utilize a support material such as a vaginal tape, mesh or sling (made of synthetic material, cadaveric tissue, the patient's own tissue, or a combination of any of these three).

[0044] The methods of the present invention are surgical techniques for the correction of stress urinary incontinence in female patients. The mainstay of the technique is the complete lack of any incision in the skin or the vaginal wall. Instead, the techniques rely upon punctures in the skin or vaginal wall. Further, the techniques utilize novel instruments that create tunnels in between layers of tissue. These techniques utilize these instruments to create tunnels by pushing tissue aside, rather than dissecting or cutting the tissue. Moreover, the techniques utilize the instruments to create a tunnel in the vaginal wall between the vaginal puncture (over the mid-urethral, proximal urethra or bladder neck) and the undersurface of the pubic rami (lateral to the urethra and the bladder neck) that is just big enough to allow the sling material to be inserted without the aid of the surgeons finger. In fact, the tunnels are generally smaller than the channels created in existing techniques and generally do not allow for the passage of the surgeon's finger. The use of the tunneling/guide instrument eliminates the need for the surgeon's finger guiding the needle in the vaginal channel. This technique of creation and sequential dilation of the vaginal tunnel by the tunnelers followed by the passage and guiding of the needle by the tunneler/guide instrument through the vaginal tunnel and ultimately the passage of the support material (such as sling mesh) and adjustment of the sling tension using the tunneler/guide instrument as a spacer between the sling mesh and the urethral tissue can be applied to the vaginal portion of all the techniques described in this invention.

[0045] The methods of the present invention are advantageous in that they are minimally invasive. Thus, the methods result in a generally rapid recovery from the surgery. Further, the minimally invasive nature of the invention shortens the duration of the surgery, minimizes risk of substantial blood loss, reduces the need for anesthesia and pain medication, enhances the healing of the incision, and minimizes the risk of vaginal erosion or extrusion of the mesh. The use of the tunneler/guide instrument as a spacer between the support material (e.g., sling mesh) and the urethra allows for consistent space between the urethra and the

support material (e.g., sling mesh) thus reducing the risk of urethral obstruction and urinary retention - thereby further reducing the risk of the operation. The present methods thus reduce the overall cost of the surgery and the risks inherent in the surgery.

[0046] The following detailed descriptions are of specific exemplary embodiments of the present invention. Variations of each of these embodiments will be apparent to those of skill in the art and are within the contemplated scope of the present invention.

Transobturator Percutaneous Sling Technique Outside-In fTOPS-0)

[0047] This procedure is currently the most preferred of the procedures described herein. The procedure can be done under general, spinal, epidural, or local anesthesia and with or without sedation. The patient is positioned on the operating table in the lithotomy, or modified lithotomy, or extended lithotomy position. The lower abdomen, the groins, the proximal thigh, and the genital area including the vaginal canal are prepped and draped in the usual sterile fashion. After anesthesia is administered, a weighted vaginal speculum or other forms of vaginal retractors are placed to allow for exposure of the urethra and the bladder through the anterior vaginal wall.

[0048] A Foley catheter is placed in the bladder to drain the bladder. One or two Allis clamps (or other forms of retraction of the vaginal wall) are placed onto the vaginal wall over the mid urethra. A third clamp may be used onto the anterior vaginal wall overlying the bladder neck, proximal urethra or the bladder to aid in exposure of the anterior vaginal wall particularly the part of the vaginal wall between the urethra and the endopelvic fascia on either side of the midline. This will aid in the passage of the novel needle or tunneler in the plane of tissue between the vaginal wall and the urethra without disruption or puncture or injury of the urethral wall or the vaginal wall.

[0049] A solution such as normal saline, local anesthetic, vasoconstrictor or any combination of the above may be injected in the sub-mucosal plane extending from the urethral meatus caudally to the bladder neck or bladder base cephalad, and between the lateral margins of the anterior vaginal wall, or any area within the confines of this zone. This injection will aid in the development of the sub mucosal plane for the passage of the novel needle or tunneler underneath the mid or proximal urethra.

[0050] A puncture is created in the vaginal wall over the mid-urethra, proximal urethra or the bladder neck using the tip of the smallest tunneler. The tunneler is then advanced in a sub-mucosal plane between the vaginal wall and the urethra starting at the vaginal puncture site and advancing towards the endopelvic fascia (undersurface of the pubic ramus) at the junction of the anterior and lateral vaginal wall. Once this narrow tunnel is created, the small tunneler is removed and a larger tunneler is advanced in a similar fashion to widen the tunnel. This process is repeated using larger tumαelers until the tunnel is wide enough to allow the passage of the sling mesh. Tunnelers for use in this embodiment can be about 1 mm to about 15 mm wide. Preferably, the process begins with a tunneler that is approximately 1.5 mm wide and ends with a tunneler that is approximately 10 mm wide. More preferably, the process utilizes tunnelers that are approximately 1.5 mm, 2.5 mm, 5 mm, 7.5 mm, and 10 mm wide. The process is repeated on the opposite side of the vaginal wall using the same puncture through the vaginal wall.

[0051] Once the tunnels are created on both sides of the midline, a needle (for example, those used in known sling procedures) is then used. The needle is used to puncture the skin at the genitofemoral fold overlying the Obturator Fossa. The needle is then advanced through the Obturator Fossa transversing the adductor and obturator muscle group and the fascia and then rotating medially towards the tunnel previously created in the vaginal wall. The tip of the needle is guided in and advanced through the previously created vaginal tunnel until the tip of the needle exits through the puncture site in the vaginal wall.

[0052] Preferably, a tunneler/guide instrument with a generally concave surface may be placed in the vaginal tunnel to provide a landmark to guide the surgeon in inserting the needle and to aid the surgeon in guiding the needle into the vaginal tunnel. This tunneler/guide instrument also helps prevent penetration of the bladder and/or urethra by the needle.

[0053] Once the tip of the needle exits through the vaginal puncture site, one free end of the support material (e.g., sling mesh) is then threaded through the needle, and the needle is retracted pulling the support material (e.g., sling mesh) with it through the vaginal tunnel, obturator fascia and muscle and the adductor muscle group through the Obturator Fossa until it exits through the skin puncture site at the genitofemoral fold. The needle is

then removed leaving the support material (e.g., sling mesh) in place. This process is then repeated on the opposite side in a similar fashion. Once the sling mesh is in position over the mid-urethra, proximal urethra or the bladder neck, the tension of the sling mesh is adjusted to achieve continence. The tunneler/guide instalment can be used as a spacer to create the necessary space between the sling mesh and the urethral wall while the sling tension is being adjusted. This last step would ensure enough space between the urethra and the sling mesh to reduce the chance of postoperative urethral obstruction and urinary retention. Once the sling mesh tension is adjusted, the excess support material (e.g., sling mesh) is excised at the level of the skin in the puncture site at the genitofemoral folds. The puncture wounds in the vaginal wall and the genitofemoral folds are closed with skin adhesive or sutures.

[0054] In an alternative embodiment, the novel needle of the invention is used to create a puncture at the genital-femoral crease. The needle is inserted so as to traverse the patient's obturator fossa, muscles and fascia. Once the needle traverses the obturator, it is rotated toward the vaginal canal so as to create a tunnel through which the sling material can be inserted. When the tip of the needle meets the vaginal canal at the junction of the lateral and anterior walls, the needle is advanced in the sub-mucosal tunnel as the surgeon's finger on the outside of the vaginal wall guides it and prevents the tip of the needle from penetrating the vaginal wall. The support material (e.g., sling mesh) and post-surgical steps are substantially similar to those described in the PTVT techniques.

[0055] TMs technique of creation and sequential dilation of the vaginal tunnel by the tunneler instruments followed by the passage and guiding of the needle by the tunneler/guide instrument through the vaginal tunnel and ultimately the passage of the support material (e.g., sling mesh) and adjustment of the sling tension using the tunneler/guide instrument as a spacer between the sling mesh and the urethral tissue can be applied to the vaginal portion of all the techniques described in this invention. Transobturator Percutaneous Sling Technique hi-Out (TOPS D

[0056] This procedure is currently the second-most preferred procedure of those described herein. The procedure can be done under general, spinal, epidural, local anesthesia, and with or without sedation. The patient is positioned on the operating table in the lithotomy, or modified lithotomy, or extended lithotomy position. The lower abdomen, the

groins, the proximal thigh, and the genital area including the vaginal canal are prepped and draped in the usual sterile fashion. After anesthesia is administered, a weighted vaginal speculum or other forms of vaginal retractors are placed to allow for exposure of the urethra and the bladder through the anterior vaginal wall.

[0057] A Foley catheter is placed in the bladder to drain the bladder. One or two Allis clamps (or other forms of retraction of the vaginal wall) are placed onto the vaginal wall over the mid-urethra. A third clamp may be used onto the anterior vaginal wall overlying the bladder neck, proximal urethra or the bladder to aid in exposure of the anterior vaginal wall particularly the part of the vaginal wall between the urethra and the endopelvic fascia on either side of the midline. This will aid in the passage of the novel needle or tunneler in the plane of tissue between the vaginal wall and the urethra without disruption or puncture or injury of the urethral wall or the vaginal wall.

[0058] A solution such as normal saline, local anesthetic, vasoconstrictor or any combination of the above may be injected in the sub mucosal plane extending from the urethral meatus caudally to the bladder neck or bladder base cephalad, and between the lateral margins of the anterior vaginal wall, or any area within the confines of this zone. This injection will aid in the development of the sub mucosal plane for the passage of the novel needle or tunneler underneath the mid or proximal urethra.

[0059] The novel needle of the invention is used to create a puncture in the anterior vaginal wall in the midline over the bladder neck, proximal or mid-urethra. The needle is advanced in the sub-mucosal tunnel as the surgeon's finger guides it so as to create a channel through which the sling material can be inserted. The needle is then rotated so as to traverse the patient's obturator. Once the needle traverses the obturator, it is further rotated toward the genital-femoral crease. When the tip of the needle is rotated until it creates a puncture at the patient's genital-femoral crease. The support material and postsurgical steps are substantially similar to those described in the PTVT techniques.

[0060] In an alternative embodiment, a puncture is created in the vaginal wall over the mid-urethra, proximal urethra or the bladder neck using the sharp tip of the smallest tunneler. The tunneler is then advanced in a sub-mucosal plane between the vaginal wall and the urethra starting at the vaginal puncture site and advancing towards the endopelvic fascia

(undersurface of the pubic ramus) at the junction of the anterior and lateral vaginal wall. Once this narrow tunnel is created, the smallest tunneler is removed and a larger tunneler is advanced in a similar fashion to widen the tunnel. This process is repeated using larger tunnelers until the tunnel is wide enough to allow the passage of the sling mesh. Tunnelers for use in this embodiment can be about 1 mm to about 15 mm wide. Preferably, the process begins with a tunneler that is approximately 1.5 mm wide and ends with a tunneler that is approximately 10 mm wide. More preferably, the process utilizes tunnelers that are approximately 1.5 mm, 2.5 mm, 5 mm, 7.5 mm, and 10 mm wide. The process is repeated on the opposite side of the vaginal wall using the same puncture through the vaginal wall. Once the tunnels are created on both side of the midline, a standard needle (such as those used in known sling procedures) is then used in a fashion similar to the use of the novel needle described above. The remainder of the procedure is also done as described above (in the TOPS-O embodiment).

Out-hi Percutaneous TVT (PTVT-O)

[0061] This is a minimally invasive TVT technique. The procedure can be done under general, spinal, epidural, or local anesthesia, and with or without sedation. The patient is positioned on the operating table in the lithotomy, or modified lithotomy, or extended lithotomy position. The lower abdomen, the groins, the proximal thigh, and the genital area including the vaginal canal are prepped and draped in the usual sterile fashion. After anesthesia is administered, a weighted vaginal speculum or other forms of vaginal retractors are placed to allow for exposure of the urethra and the bladder through the anterior vaginal wall.

[0062] A Foley catheter is placed in the bladder to drain the bladder. One or two Allis clamps (or other forms of retraction of the vaginal wall) are placed onto the vaginal wall over the mid-urethra. A third clamp may be used onto the anterior vaginal wall overlying the bladder neck, proximal urethra or the bladder to aid in exposure of the anterior vaginal wall particularly the part of the vaginal wall between the urethra and the endopelvic fascia on either side of the midline. This will aid in the passage of the novel needle or tunneler in the plane of tissue between the vaginal wall and the urethra without disruption or puncture or injury of the urethral wall or the vaginal wall.

[0063] A solution such as normal saline, local anesthetic, vasoconstrictor or any combination of the above may be injected in the sub mucosal plane extending from the urethral meatus caudally to the bladder neck or bladder base cephalad, and between the lateral margins of the anterior vaginal wall, or any area within the confines of this zone. This injection will aid in the development of the sub-mucosal plane for the passage of the special needle or dilator underneath, the mid or proximal urethra.

[0064] A puncture in the skin in the supra-pubic region (0-3 inches above the symphysis pubis and 0-3 inches lateral to the midline then created on the right or the left side of the patient using a curved needle with a 1 cm (l-4cm) wide sharp tip. The curved needle is then advanced in a controlled fashion through the skin and subcutaneous tissue passing lateral to the midline through the rectus muscle and the retropubic space behind the pubic bone and through the medial margins of the endopelvic fascia. As the needle passes through the endopelvic fascia, it is rotated medially towards the mid-urethra. As the needle approaches the crease between the lateral and the anterior vaginal wall, a finger in the vaginal canal identify the needle and guides it into a sub-mucosal plane at the level of the mid urethra, proximal urethra, or bladder neck without puncturing the vaginal wall, urethral wall, or bladder wall.

[0065] Once the needle reaches the sub-mucosal plane of the vagina it is then guided by a finger in the vaginal canal to pass in the sub mucosal plane between vaginal wall and the urethral wall. The needle is guided towards the midline over the mid-urethra, proximal urethra, or bladder neck. This step of the procedure may be aided by the application of gentle traction on the clamps previously applied to the vaginal wall. Once the needle tip is over the midline the tip of the needle is used to puncture the vaginal wall in the midline over the mid urethra or proximal urethra or bladder neck or any area in-between these landmarks. The tip of the needle is then advanced through the puncture in the vaginal wall until the eye of the needle is clearly visible and accessible through the vaginal canal.

[0066] A support material such as a vaginal tape, mesh or sling (made of synthetic material, cadaveric tissue, the patient's own tissue, or a combination of any of the these three) is then threaded through the needle or secured to the needle, the needle is retracted back all the way until it is pulled out through the puncture site previously created in the skin pulling

the tape, sling or mesh with it. At this point the needle is completely removed from the patient body, and the vaginal sling, tape or mesh is in place with one end exiting through the puncture site in the vaginal wall over the mid urethra, proximal urethra or bladder neck (or any area between these landmarks), and the other end of the sling, tape or mesh exiting through the skin puncture site (previously created) in the supra-pubic region. The sling, mesh, or tape is in a sub-mucosal plane lateral to the urethra passing through the endopelvic fascia, retropubic space, rectus muscle and exiting through the subcutaneous tissue and skin through the puncture site previously created.

[0067] The procedure of skin puncture and passage of the curved needle is repeated on the opposite side of the midline (left or right i.e. the opposite side of the first puncture site) in a similar fashion until the tip of the wide sharp tip curved needle exits through the same puncture site (previously created) in the anterior vaginal wall in the midline over the mid urethra, proximal urethra, or bladder neck (or any area between these landmarks) where the sling, tape, or mesh is already placed. Once the tip of the needle exits the puncture site in the anterior vaginal wall in the midline, the free end of the sling, tape or mesh in the vagina is threaded through the eye of the needle or secured to the needle and the needle is retracted back all the way until it exits through the skin puncture site on through which it first passed. At this point the needle is outside the body of the patient.

[0068] The vaginal sling, tape, or mesh is passing through the skin puncture site on one side of the patient and the subcutaneous tissue, passing through the rectus muscle then through the retropubic space, and endopelvic fascia, and then passing crossing the vaginal canal in a sub-mucosal tunnel in the plane between the vaginal wall and the urethral wall on one side of the patient (right or left), crossing the midline underneath (below) the urethra (at the level of mid urethra, proximal urethra, or bladder neck or any area between these landmarks) and continuing on the opposite side of the patient (left or right) in a tunnel in the sub mucosal plane between the urethra and the vaginal wall, and continuing below through the endopelvic fascia, retropubic space, rectus muscle and then through the subcutaneous tissue and the skin in the supra-pubic region (exits through the skin puncture site previously created on the opposite side of the patient).

[0069] The position and tension of the sling, tape, or mesh over the mid urethra, proximal urethra or bladder neck is then checked through the puncture site in the anterior vaginal wall and the tension of the sling, tape, or mesh is adjusted using the two free ends of the sling, tape, or mesh to achieve the desired effect to achieve continence (minimal or no tension). A spacer or other device may be used to create the desired space between the sling, tape, or mesh on one side and the urethra on the other to achieve the desired effect for continence. Also the position is checked to make sure the sling, tape or mesh is not rolled or folded over the urethra or bladder neck.

[0070] At this point cystoscopy may be done to check the tape position relative to the urethra and/or to rule out urethral or bladder injury. After completion of cystoscopy (if the surgeon chooses to do it), the patient (if awake) may be asked to cough or valsalva to check for the status of continence of the patient with the bladder full of liquid. The two free ends of the tape are then cut at or below the level of the skin puncture sites on both side of the patient. The excess sling, tape, or mesh is discarded. The three puncture sites (two in the skin and one in the anterior vaginal wall) may be irrigated with antibiotic solution or other solution as deemed necessary by the surgeon. The three puncture sites are then closed using a skin sealant such as Dermabond (or other sealant) or otherwise closed with fine suture. Dressing may be applied as needed.

[0071] In an alternative embodiment a puncture is created in the vaginal wall over the mid urethra, proximal urethra or the bladder neck using the sharp tip of the smallest tunneler. The tunneler is then advanced in a sub-mucosal plane between the vaginal wall and the urethra starting at the vaginal puncture site and advancing towards the endopelvic fascia (undersurface of the pubic ramus) at the junction of the anterior and lateral vaginal wall. Once this narrow tunnel is created, the small tunneler is removed and a larger tunneler is advanced in a similar fashion to widen the tunnel. This process is repeated using larger tunnelers until the tunnel is wide enough to allow the passage of the sling mesh. Tunnelers for use in this embodiment can be about 1 mm to about 15 mm wide. Preferably, the process begins with a tunneler that is approximately 1.5 mm wide and ends with a tunneler that is approximately 10 mm wide. More preferably, the process utilizes tunnelers that are approximately 1.5 mm, 2.5 mm, 5 mm, 7.5 mm, and 10 mm wide. The process is repeated

on the opposite side of the vaginal wall using the same puncture through the vaginal wall. Once the tunnels are created on both side of the midline, a standard needle (such as those used in known sling procedures) is then used in a fashion similar to the use of the novel needle described above. The remainder of the procedure is also done as described above (in the TOPS-O embodiment).

[0072] In another alternative technique, the two needles (whether they be the novel needles of the invention or the standard needles used in conjunction with the novel tunneler) may be passed first one needle from each side of the midline as previously described all the way through the vaginal puncture site and once both needles are in the vagina, the free ends of the sling, tape, or mesh are threaded or secured, one to the end of each needle before the needles are retracted simultaneously or in sequence as described above to achieve similar results.

In-Out Percutaneous TVT (PTVT-D

[0073] This is another minimally invasive TVT technique. The procedure can be done under general, spinal, epidural, or local anesthesia, and with or without sedation. The patient is positioned on the operating table in the lithotomy, or modified lithotomy, or extended lithotomy position. The lower abdomen, the groins, the proximal thigh, and the genital area including the vaginal canal are prepped and draped in the usual sterile fashion. After anesthesia is administered, a weighted vaginal speculum or other forms of vaginal retractors are placed to allow for exposure of the urethra and the bladder through the anterior vaginal wall.

[0074] A Foley catheter is placed in the bladder to drain the bladder. One or two Allis clamps (or other forms of retraction of the vaginal wall) are placed onto the vaginal wall over the mid urethra. A third clamp may be used onto the anterior vaginal wall overlying the bladder neck, proximal urethra or the bladder to aid in exposure of the anterior vaginal wall particularly the part of the vaginal wall between the urethra and the endopelvic fascia on either side of the midline. This will aid in the passage of the novel needle or tunneler in the plane of tissue between the vaginal wall and the urethra without disruption or puncture or injury of the urethral wall or the vaginal wall.

[0075] A solution such as normal saline, local anesthetic, vasoconstrictor or any combination of the above may be injected in the sub-mucosal plane extending from the urethral meatus caudally to the bladder neck or bladder base cephalad, and between the lateral margins of the anterior vaginal wall, or any area within the confines of this zone. This injection will aid in the development of the sub-mucosal plane for the passage of the novel needle or tunneler underneath the mid or proximal urethra.

[0076] A puncture in the anterior vaginal wall in the midline over bladder neck, proximal or mid-urethra is created using the wide-tip sharp needle (with the tape, mesh, or sling attached to it), and the needle is advanced to create a tunnel in the sub-mucosal plane between the anterior vaginal wall and the urethra. The needle is advanced in this plane towards the crease at the junction of the anterior vaginal wall and the lateral vaginal wall at the level of bladder neck, proximal, or mid-urethra. The path of the tip of the needle may be aided by a finger on the outside of the anterior vaginal wall to avoid inadvertent puncture of the anterior vaginal wall. Once the needle reaches the endopelvic fascia it is then rotated towards the rectus muscle and advanced through the endopelvic fascia, retropubic space, and then through the rectus muscle, subcutaneous tissue and finally through the skin at the suprapubic region where the tip of the needle punctures the skin.

[0077] As the needle is pulled through the skin puncture, the attached tape, mesh, or sling is pulled with it. The procedure is repeated on the opposite side in a similar fashion entering the vaginal wall through the same puncture site previously created and exiting the skin in the supra-pubic region on the opposite side of the first skin puncture site.

[0078] At this point the needle is outside the body of the patient. The vaginal sling, tape, or mesh is passing through the skin puncture site on one side of the patient and the subcutaneous tissue, passing through the rectus muscle then through the retropubic space, and endopelvic fascia, and then passing crossing the vaginal canal in a sub mucosal tunnel in the plane between the vaginal wall and the urethral wall on one side of the patient (right or left), crossing the midline underneath (below) the urethra (at the level of mid urethra, proximal urethra, or bladder neck or any area between these landmarks) and continuing on the opposite side of the patient (left or right) in a tunnel in the sub-mucosal plane between the urethra and the vaginal wall, and continuing below through the endopelvic fascia, retropubic

space, rectus muscle and then through the subcutaneous tissue and the skin in the supra-pubic region (exits through the skin puncture site previously created on the opposite side of the patient).

[0079] The position and tension of the sling, tape, or mesh over the mid-urethra, proximal urethra or bladder neck is then checked through the puncture site in the anterior vaginal wall and the tension of the sling, tape, or mesh is adjusted using the two free ends of the sling, tape, or mesh to achieve the desired effect to achieve continence (minimal or no tension). A spacer or other device may be used to create the desired space between the sling, tape, or mesh on one side and the urethra on the other to achieve the desired effect for continence. Also the position is checked to make sure the sling, tape or mesh is not rolled or folded over the urethra or bladder neck.

[0080] At this point cystoscopy may be done to check the tape position relative to the urethra and/or to rule out urethral or bladder injury. After completion of cystoscopy (if the surgeon chooses to do it), the patient (if awake) may be asked to cough or valsalva to check for the status of continence of the patient with the bladder full of liquid. The two ends of the tape are then cut at or below the level of the skin puncture sites on both side of the patient. The needles and the excess sling, tape, or mesh is discarded. The three puncture sites (two in the skin and one in the anterior vaginal wall) may be irrigated with antibiotic solution or other solution as deemed necessary by the surgeon. The three puncture sites are then closed using a skin sealant such as Dermabond (or other sealant) or otherwise closed with fine suture. Dressing may be applied as needed.

[0081] In an alternative embodiment, the novel needle of the invention is not used. Instead, a puncture is created in the vaginal wall over the mid-urethra, proximal urethra or the bladder neck using the sharp tip of the smallest tunneler. The tunneler is then advanced in a sub-mucosal plane between the vaginal wall and the urethra starting at the vaginal puncture site and advancing towards the endopelvic fascia (undersurface of the pubic ramus) at the junction of the anterior and lateral vaginal wall. Once this narrow tunnel is created, the small tunneler is removed and larger tunneler is advanced in a similar fashion to widen the tunnel. This process is repeated using larger tumielers until the tunnel is wide enough to allow the passage of the sling mesh. Tumielers for use in this embodiment can be about 1

mm to about 15 mm wide. Preferably, the process begins with a tunneler that is approximately 1.5 mm wide and ends with a tunneler that is approximately 10 mm wide. More preferably, the process utilizes tunnel ers that are approximately 1.5 mm, 2.5 mm, 5 mm, 7.5 mm, and 10 mm wide. The process is repeated on the opposite side of the vaginal wall using the same puncture through the vaginal wall. Once the tunnels are created on both side of the midline, a standard needle (such as those used in known sling procedures) is then used in a fashion similar to the use of the novel needle described above. The remainder of the procedure is also done as described above.