WO2007109759A2

WO2007109759A2 - Female urinary incontinence treatment device and method

Info

Publication number: WO2007109759A2
Application number: PCT/US2007/064640
Authority: WO
Inventors: Doug Evans
Original assignee: C. R. Bard, Inc.
Priority date: 2006-03-22
Filing date: 2007-03-22
Publication date: 2007-09-27
Also published as: WO2007109759A3

Abstract

A method of treating female urinary incontinence comprising providing a surgical instrument having a needle, the needle having a connection end and a free end, and the free end of the needle having a curved portion . The handle receives the connection end of the needle such that the needle is coupled to the handle at the connection end There is provided an implant having an attachment portion provided on at least one end, and the needle is introduced through an incision provided in an anterior vaginal wall so that the free end of the needle is proximate to an ischiopubic ramus The handle is rotated such that the curved portion passes through an obturator foramen and is exposed at the incision An end of the implant is attached to the free end of the needie, and the handle is rotated such that the implant is retracted with the free end of the needle and pulled through the obturator foramen.

Description

FEMALE URINARY INCONTINENCE TREATMENT DEViCE AND METHOD

The present application claims benefit of priority of U.S. Provisional Application No 60/743,633, filed March 22, 2006, which is incorporated herein by reference in its entirety.

The present disclosure relates to a surgical instrument and method of use, such as a surgical instrument and method for treating female urinary incontinence

Urethral slings are increasingly being used for treating female urinary incontinence, such as stress urinary incontinence Generally, urethral slings are placed beneath a patient's urethra in order to provide support, thereby preventing, or at least minimizing, urinary incontinence, The sling member is normally implanted in the patient's tissue by using a surgical instrument to help position an implant

One known sung procedure involves placing a strip of an implant material (natural tissue or synthetic mesh) under the urethra and securing it to the rectus fascia or other portions of the patient's anatomy with sutures to hold the implant in position during the healing process

More recently, improved techniques have been developed that speed the implant process, by reducing the number of incisions made and altering the pathways by which the tissue implant is introduced into the body These improvements, which employ specialized instrumentation, help to reduce operative time and have made the procedure less invasive

Known techniques generally require that an implant be joined to an introducer needle The implant is inserted into, and pulled through the body Then, in a subsequent step, the implant is detached from the needle At least one deficiency with existing surgical instruments for treating urinary incontinence, however, is that they are typically unwieldy, awkward and time-consuming to attach and/or detach to an implant to or from a surgical instrument

Yet another potential deficiency with existing surgical procedures is that in addition to a midline vaginal incision, incisions must also be made to the groin and/or abdominal area to provide a needle introduction incision for the surgical instrument

Therefore, a need has arisen for a surgical instrument, system and method which allow for a less invasive surgical procedure to treat female urinary incontinence; and which the surgical instrument has a very simple and intuitive design SUMMARY OF THE INVENTION

A non-limiting embodiment of the present disclosure provides a surgical instrument for treating female urinary incontinence having a needle having a connection end and a free end, wherein the free end of the needle has a curved portion, and the surgical instrument has a handle that receives the connection end of the needle such that the needle is coupled to the handle at the connection end

Another feature includes the needle having a tip portion configured to attach to an end of an implant, and in a further feature, the surgical instrument is provided having a generally T-shape handle

According to an additional feature the needle body is provided having a straight shaft portion that extends between the handle and the curved portion Further, the curved portion may have a diameter between 0.5 and 1 5 inches.

In an additional feature, the surgical instrument comprises at least two surgical instruments having opposing needle orientations Another non-limiting embodiment of the present disclosure provides a method of using a surgical system comprising providing a surgical instrument having a needle having a connection end and a free end, wherein the free end of the needle has a curved portion, and the curved portion has a diameter of approximately 0 5 to approximately 1 25 inches Further, providing a handle that receives the connection end of the needle such that the needle is coupled to the handle at the connection end, providing an implant having first and second ends having an opening provided on at least one of the ends, and the opening being configured to receive an end of the curved portion. The method also includes introducing the needle through an incision provided in an anterior vaginal wall so that the free end of the needle is proximate to an ischiopubic ramus, rotating the handle such that the curved portion passes through an obturator foramen, inserting the implant through the incision provided in the anterior vaginal wall and attaching the implant to the free end of the needle, and rotating the handle such that the implant is retracted with the free end and pulled through the obturator foramen..

According to an additional feature, an implant comprised of mesh or tissue, or any other suitable material known to one of ordinary skill in the art, may be provided

Another feature includes providing the end of the curved portion with a tip portion configured to attach to an end of an implant, and in a further feature, the handle may be provided having a generally T-shape

Accordingly to an additional feature, the needle may be provided having a generally straight shaft portion extending between the handle and the curved portion.

In an additional feature the curved portion may be provided having a generally helical shape, In yet still another feature the curved portion may be provided so that the curved portion extends in a direction generally perpendicular to the generally straight shaft portion, and in a further feature, the curved portion may be provided having a generally U-shape.

A non-limiting embodiment of the present invention provides a method for treating female urinary incontinence comprising providing a surgical instrument having a needle including a connection end and a free end, wherein the free end of the needle body has a curved portion Further, there is a handle that receives the connection end of the needle to couple the needle to the handle at the connection end. Further, providing an implant having an opening provided on at least one end, introducing the needle proximate to an ischiopubic ramus, rotating the needle handle such that an end portion of the curved portion is proximate the opening provided on the at least one end of the implant, attaching the implant to the end portion of the needle, and rotating the handle such that the end portion of the implant is retracted with the needle and pulled through an foramen oburator

In a further embodiment, a second surgical instrument having a needle, the needle having a connection end and a free end, wherein the free end of the needle has a curved portion, may be provided The second surgical instrument may have a handle that receives the connection end of the needle such that the needle is coupled to the handle at the connection end Further, the needle of the second surgical instrument may be introduced through an incision provided in an anterior vaginal wall so that the free end of the needle is proximate to an opposite side of the ischiopubic ramus The handle of the second surgical instrument may be rotated such that the curved portion passes through an opposite side of the obturator foramen and is exposed at the incision, and attaching an opposite end of the implant to the free end of the needle Further, the handle of the second surgical instrument may be rotated so that the opposite end of the implant is retracted with the free end and pulled through an opposite side of the obturator foramen Further, the surgical instruments may be provided so that they are mirror images of one another

In an additional feature the free end of the needle is inserted through an incision, and in a further feature, the first and second ends of the implant are pulled out of the incision and trimmed

In yet still another feature, the curved portion may be provided at the free end of the needle in a direction extending generally perpendicular to the straight shaft portion.

Further, because the curved portion of the free end of the needle is configured to wrap around the ischiopubic ramus there is no need for an inside/outside approach

Other exemplary embodiments and advantages of the present invention may be ascertained by reviewing the present disclosure and the accompanying drawings, and the above description should not be considered to limit the scope of the present invention

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is further described in the detail description which follows, in reference to the noted plurality of drawings, by way of non-limiting examples of examplary embodiments of the present invention, in which like characters represent like elements throughout the several views of the drawings, and wherein:

Fig 1 is a perspective view of a pair of surgical instruments, having opposite needle orientations, and an implant according to an embodiment of the present invention;

Fig 2 is a perspective schematic view of a surgical instrument of an embodiment of the present invention entering through one side of an obturator foramen; Fig 3 is a perspective schematic view of the surgical instrument of Fig 1 through one side of the obturator foramen;

Fig 4 is a perspective schematic view of the surgical instrument positioned around an ischiopubic ramus according to an embodiment of the present invention;

Fig 5 is a perspective schematic view of attaching one end of the implant to the tip of the surgical instrument according to an embodiment of the present invention;

Fig 6 is a perspective schematic view of rotating the handle of the surgical instrument so that an end of the implant is retracted, with the free end of the surgical instrument, through the obturator foramen;

Fig 7 is a perspective schematic view of one end of the implant positioned on the ischiopubic romus, and the other end of the implant positioned outside the incision;

Fig 8 is a perspective schematic view of a surgical instrument having an opposite needle orientation from the surgical instrument of Fig 2, and passing through an opposite side of the obturator foramen;

Fig 9 is a perspective schematic view of attaching an opposite end of the implant to the tip of the surgical instrument according to an embodiment of the present invention;

Fig 10 is a perspective schematic view of rotating the handle of the surgical instrument so that the opposite end of the implant is retracted, with the free end of the surgical instrument, through the obturator foramen; and

Fig 11 is a perspective schematic view of the implant passing through opposite sides of the obturator foramen, and position on the ischiopubic romus beneath the uterus

The particulars shown herein are by way of example and for purposes of illustrative discussion of the embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the present invention In this regard, no attempt is made to show structural details of the present invention in more detail than is necessary for the fundamental understanding of the present invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the present invention may be embodied in practice

Referring to the drawings, wherein like characters represent ϋke elements, Fig 1 shows a perspective view of surgical instruments (or introducer needles) 10 and 10', respectively, having a needle 12 according to embodiments of the present invention The needle 12 has a generally straight shaft portion 13 that extends between a handle 11 and a free end 14 of the needle 12 Opposite the free end 14, there is a connection end 15 that connects the needle to the handle 11 The needle 12 is shown having a curved portion 14a at its free end 14 The handle 11 is provided having a generally T-shape In addition, the curved portion 14a at the free end 14 of the needle 12 may have a diameter between approximately 0 5 and approximately 1 5 inches Therefore, by utilizing a surgical instrument 10 having a relatively small diameter when compared to that of a widely used conventional surgical instrument, a less invasive surgery can be performed According to various embodiments, the shaft of the needle may be constructed of any suitable biocompatible material, such as stainless steel The handle can be comprised of a polymeric material

In addition, the curved portion may have a generally U-shape The configuration of the shaft portion 13 and the free end 14 provides the surgical instrument 10 with a minimally invasive structure The generally straight shaft portion 13 has a length sufficient to keep the handle 11 outside of the working area during a surgical procedure, e g , from about 5 to about 20 cm, such as from about 6 to about 15 cm, or from about 7 to about 12 cm, or from about 8 to about 10 cm The generally T-shape handle 11 provides the surgical instrument 10 with maximum torque capabilities.

The curved portion at the free end 14 is provided with a relatively small diameter to further reduce invasiveness of the surgical instrument 10 during a surgical procedure Further, the needle 12 is provided with a length sufficiently small so that it is not long enough to reach the lateral aspects of an obturator foramen B, thereby further reducing the invasiveness of the surgical procedure, and preventing accidental injury to the obturator foramen Further, an implant 20 for supporting a uterus is shown having ends 20a and 20 b which have a smaller width than the central portion 20c of the implant The implant can comprise mesh and/or tissue, with a length ranging from about 5 cm to about 25 cm. The mesh can be comprised of a polypropylene mesh According to various embodiments, the mesh can be at least partially enclosed by a sheath Suitable non-limiting examples of implants, and methods and devices for attaching the implants to the needles, can be found in Patent Application Publication Nos. US 2004/0144395, published July 29, 2004, and US 2006/0015069, published January 19, 2006, (the disclosures of which are each incorporated herein by reference in their entirety),

As shown in Fig, 8, a surgical instrument 10 may be provided with an opposing needle 12' (as illustrated in Fig. 1) orientation, La., the surgical instrument 10' may be configured to pass and wrap around a side of the obturator foramen B that is generally diametrically opposite to a side that the surgical instrument 10 of Fig 2 is configured to pass and wrap around.

Thus, the surgical instruments 10 and 10', shown in Fig 1 , are usable together to facilitate placement of both ends 20a and 20b of the implant 20 on the ischiopubic ramus A, thereby positioning a central portion 20c of the implant beneath the urethra U to provide support,

Referring again to Fig. 1 , an implant is shown having a generally elongated shape The first and second ends 20a and 20b, respectively, of the implant are configured to pass through the obturator foramen B and wrap around the ischiopubic ramus A ( as illustrated in Fig. 10) In addition, the implant 20 may be a mesh or tissue implant, and may have a self anchoring design it should also be appreciated by those skilled in the art that the implant may be comprised of any other suitable material.

As illustrated in Figs 2-11 , there is a surgical instrument 10, a method of using a surgical system and a surgical method for treating female urinary incontinence according to an embodiment of the invention Fig. 2 shows the surgical instrument 10 positioned proximate an ischiopubic ramus A. Accordingly, an appropriate incision N may be provided in an area that allows for the free end 14 (as illustrated in Fig 1) of the needle 12 to be positioned proximate the ischiopubic ramus A In this regard, the incision N is illustrated, in accordance with an embodiment of the invention, to indicate a general procedure The location of the incision as shown in the drawings is provided for conceptual understanding and is not limited to the shape or location illustrated, Thus, after inserting the surgical instrument through the incision, the handle 11 of the surgical instrument 10 is rotated such that a tip (/ e , a free end) of the needle 12 provided at the free end 14 of the needle 12 passes through the obturator foramen B, and the curved portion of the free end 14 is configured to wrap around (but not necessarily come into contact with) the ischiopubic ramus A. The needle's 12 size, shape and diameter also allows the surgeon to keep the tip of the needle 12 away from the bladder, bowel and vessels (all not shown), and close to the ischiopubic ramus A; further preventing accidental injury to a patient Thus, the curved portion of the needle 12 makes it possible to easily position the free end 14 of the needle 12 proximate to a single incision N provided, e g , in an anterior vaginal wall Thus, the implant 10 may be implanted in the patient through only this single vaginal incision N , In addition, a lateral extending dissection may be provided approximate the ischiopubic ramus A to allow passage of the needle 12 Further, the curved portion also facilitates the attachment of the needle 12 to the implant 20 because by rotating the handle 11 to pivot the needle 12, the tip of the curved portion is positioned proximate an incision and a first end 20a of the implant 20.

Thus, by rotating the handle 11 of the surgical instrument 10 in an opposite direction, the needle 12 is retracted through the obturator foramen B along with a first end 20a of the implant 20 (as iilustrated in Fig, 6). The first end 20a of the implant 20 may be positioned on the ischiopubic ramus A through a dissection (not shown) provided adjacent a bone of the ischiopubic ramus A

Further, as discussed above, a surgical instrument 10' having an opposite needle 12 orientation (/ e , it is a mirror image) from that of the aforementioned surgical instrument, (as illustrated in Fig. 1), may be used to position the second end 20b of the implant 20 on a side of the ischiopubic ramus A facing opposite the first end 20a of the implant 20 (i.e., the second end 20b is implanted at the ischiopubic ramus A' that is at the opposite side of the patient (the left side of the patient in Figs 8-10)).. Accordingly, the second end 20a of the implant can be connect to the free end 14' of the needle 12' (as illustrated in Fig 9)

Therefore, by rotating the handle 11 of the surgical instrument 10 in an opposite direction, the needle 12¹ is retracted through the obturator foramen B' (that is at the opposite side of the patient (the left side of the patient in Figs 8-10)) along with a second end 20b of the implant 20 The second end 20b of the implant 20 may be positioned on the ischiopubic ramus A' through a dissection provided adjacent a bone of the ischiopubic ramus A' Thus, the first and second ends 20a and 20b of the implant 10 are positioned on the ischiopubic ramus A, A' such that a central portion 20c of the impiant 20 forms a sling to support a urethra (as illustrated in Fig. 11).

As shown in Fig 11 , the ends 20a and 20b of the implant 10 may be pulled out through an incision, e.g., the single incision N made in the anterior vaginal wall Accordingly, first and second ends 20a and 20b, respectively, of the implant 10 may be trimmed and the incision may be closed.

Further, it should be appreciated that the needle 12' size, shape and diameter of the surgical instrument 10' having an opposing needle 12' orientation, also allows the surgeon to keep the tip of the needle 12' away from the bladder, bowel and vessels (not shown), and to close the ischiopubic ramus A', further reducing the risk of accidental injury to a patient

In addition to providing a minimally-invasive surgical instrument 10, the present invention also allows a surgeon to use his/her fingers to initially position the needle 12 easily Also, there is an added benefit of palpation from the start to the end of passing the needle 12 through the obturator foramen B, B'.

Also, the curved portion of the needle 12 may be provided with a helical shape geometry to further facilitate passage of the needle 12 Accordingly, the curved portion may be provided at the free end 14 of the needle 12 in a direction extending generally perpendicular to the straight shaft portion 13, Thus, the free end 14 of the needle 12 is configured to pass through the obturator foramen B, B¹ such that the needle 12 is positioned close to the ischiopubic ramus A, A' Thus, alternatively and by way of non- limiting example, the curved portion may be provided with a generally U-shape in order to facilitate passage of the needle 12 through the obturator foramen B, B'

Further, because the implant 20 wraps around the ischiopubic ramus A, A', and because the implant may be implanted in the patient through only a single vaginal incision, there is no need to pass the implant through the thigh fold or movement area (not shown) Thus, there is little resulting pain or discomfort caused in patients from moving their legs. In addition, no sutures, buttons or tying are required

Further, positioning the implant on the ischiopubic ramus A, A¹ makes it possible to reduce the overall geometry of the implant 20, thereby saving cost In this regard, the end portions 20a and 20b may be narrowed to a width of approximately 0 5 to approximately 10 mm; whereas the central section 20c of the implant 10, responsible for supporting the urethra U, may remain the same, e.g., a width of approximately 1 to approximately 1 ,5 cm Thus, significant cost savings may be realized by the reduction in material.

It should further be appreciated that the present invention may also allow for a low- cost kit comprising two surgical instruments 10 having opposing needle 12 orientations, and an appropriate implant 20.

It is further noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention While the present invention has been described with reference to a preferred embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims

Claims

WHAT IS CLAIMED IS:

1. A surgical instrument comprising: a needle having a connection end and a free end, wherein said free end of said needle has a curved portion, wherein said curved portion has a diameter of approximately 0 5 to approximately 1 25 inches; and a handle that receives said connection end of said needle such that said needle is coupled to said handle at said connection end,

2. The surgical instrument according to claim 1 , wherein said needle has a tip portion configured to attach to an end of an implant.

3 The surgical instrument according to claim 2, wherein the handle has a generally T- shape.

4 The surgical instrument according to claim 1 , wherein said needle comprises a generally straight shaft portion extending between said handle and said curved portion.

5 The surgical instrument according to claim 1 , wherein said surgical instrument comprises at least two surgical instruments having opposing needle orientations

6. The surgical instrument according to claim 1 , wherein said curved portion has a generally helical shape

7 The surgical instrument according to claim 4, wherein said curved portion extends in a direction generally perpendicular to said generally straight shaft portion.

8 The surgical instrument according to claim 1 , wherein said curved portion has a generally semi-circular shape

9 A method of using a surgical system comprising: providing a surgical instrument having a needle having a connection end and a free end, wherein the free end of the needle has a curved portion, and the curved portion has a diameter of approximately 0 5 to approximately 1.25 inches; providing a handle that receives the connection end of the needle such that the needle is coupled to the handle at the connection end; providing an implant having first and second ends having an opening provided on at least one of the ends, the opening being configured to receive an end of the curved portion; introducing the needle through an incision provided in an anterior vaginal wall so that the free end of the needle is proximate to an ischiopubic ramus; rotating the handle such that the curved portion passes through an obturator foramen; inserting the implant through the incision provided in the anterior vaginal wall and attaching the implant to the free end of the needle; and rotating the handle such that the implant is retracted with the free end and pulled through the obturator foramen

10 The method of using a surgical system according to claim 9, wherein the implant is a mesh implant or tissue implant

11 The method of using a surgical system according to claim 9, further comprising providing the end of the curved portion with a tip portion configured to attach to an end of an implant,

12. The method of using a surgicai system according to claim 9, further comprising providing the handle with a generally T-shape

13 The method of using a surgical system according to claim 9, further comprising providing the needle having a generally straight shaft portion extending between the handle and the curved portion

14 The surgical instrument according to claim 9, wherein the surgical instrument comprises at least two surgical instruments having opposing needle orientations,

15 The method of using a surgical system according to claim 9, further comprising providing the curved portion having a generally helical shape

16 The method of using a surgical system according to claim 15, further comprising providing the curved portion so that the curved portion extends in a direction generally perpendicular to the generally straight shaft portion,

17 The method of using a surgical system according to claim 9, further comprising providing the curved portion with a generally semi-circular shape,

18 A method of treating female urinary incontinence using a surgical instrument having a needle, the needle having a connection end and a free end, wherein the free end of the needle has a curved portion, wherein a handle receives the connection end of the needle such that the needle is coupled to the handle at the connection end, the method comprising: introducing the needle through an incision provided in an anterior vaginal wall so that the free end of the needle is proximate to an ischiopubic ramus; rotating the handle such that the curved portion passes through an obturator foramen and the free end is exposed at the incision; attaching an end of an implant to the free end of the needle; and rotating the handle such that the implant is retracted with the free end and pulled through the obturator foramen,

19 The method of treating female urinary incontinence according to claim 18, wherein the surgical instrument is a first surgical instrument, and wherein the method further comprises: providing a second surgical instrument having a second needle, the second needle having a connection end and a free end, wherein the free end of the second needle has a curved portion, wherein a second handle receives the connection end of the second needle such that the second needle is coupled to the second handle at the connection end of the second surgical instrument; introducing the second needle through the incision so that the free end of the second needle is proximate to an opposite ischiopubic ramus; rotating the second handle such that the curved portion of the second surgical instrument passes through an opposite obturator foramen and the free end of the curved portion of the second needle is exposed at the incision; attaching an opposite end of the implant to the free end of the second needle; and rotating the second handle such that the opposite end of the implant is retracted with the free end and pulled through the opposite obturator foramen

20 The method of treating female urinary incontinence according to claim 19, further comprising attaching the implant to the free end of at least one of the first and second surgical instruments by a hole provided on at least one end of the implant

21 The method of treating female urinary incontinence according to claim 19, further comprising: pulling out the first and second ends of the implant through the incision; and trimming the first and second ends of the implant

22 The method of treating female urinary incontinence according to claim 19, wherein the implant has a self-anchoring design.

23. The method of treating female urinary incontinence according to claim 19, wherein the first and second needle are each provided with a generally straight shaft portion extending between the handle and the curved portion

24. The method of treating female urinary incontinence according to claim 23, wherein the curved portion of the respective first and second surgical instruments are provided extending in a direction generally perpendicular to the generally straight shaft portion

25 The method of treating female urinary incontinence according to claim 19, wherein the curved portion of the respective first and second surgical instruments are provided having a generally U-shape

26. The method of treating female urinary incontinence according to claim 19, wherein the curved portion of the respective first and second surgical instruments are provided having a generally helical shape

27 The method of treating female urinary incontinence according to claim 19, wherein the curved portion of the respective first and second surgical instruments are provided having a generally halo shape

28. The method of treating female urinary incontinence according to claim 19, wherein the entire procedure is performed through a single incision provided in the anterior vaginal wall