Abstract:
A tunneling device is provided to assist in passing a suture or tape into a body. The tunneling device includes an outer assembly and an inner member or stylet, having a light transmissive distal tip, positioned within the outer assembly. The outer assembly is provided with a light port or guide to transmit light towards the distal tip of the stylet. The disclosed illuminated tunneling device is particularly adapted for use in an Intravaginal Slingplasty procedure. The illuminated tunneling device can be provided with an external source of light or may include an integral self-contained source of light. Additionally, a light guide, or light tube, may be formed integral with the outer tubular member or may be provided as a separate element.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims the benefit of U.S. Patent Application Ser. No. 60/694,795 filed provisionally on Jun. 28, 2005, and titled, “Illuminated IVS Tunneling Device.” 
     
    
     BACKGROUND  
       [0002]     1. Technical Field  
         [0003]     The present disclosure relates to an apparatus and method for illuminating an Intravaginal Slingplasty (IVS) tunneling device. More particularly, the present disclosure relates to a method and apparatus for illuminating the tip of an IVS tunneling device to allow illumination of an incision within the vaginal canal and, more particularly, to provide an illuminated tip of an IVS tunneling device, the location of which can be viewed unassisted through the abdominal wall with the naked eye.  
         [0004]     2. Background of Related Art  
         [0005]     Recurrent female urinary incontinence, or the inability to control urination, is a major and debilitating problem affecting millions of women in the United States alone. A particular type of urinary incontinence that frequently occurs in women is “stress urinary incontinence,” which occurs during coughing, straining, or heavy lifting. A typical procedure to alleviate this problem is the insertion of a tape or a suture beneath the urethra to provide support and pressure on the urethra to avert unintentional discharge.  
         [0006]     Various devices have been designed to facilitate the insertion of the tape to provide support for the urethra. One particularly useful device employs a hollow tube or tunneling device and stylet to safely insert the tape without abrasion to surrounding tissues. An exemplary a device of this type is disclosed in U.S. Pat. No. 5,112,344 to Petros et al., the entire disclosure of which is incorporated herein by reference.  
         [0007]     A particular type of Intravaginal Slingplasty (IVS) procedure involves forming an incision in the midline of the vaginal wall and using the tunneling device to advance a first end of the suture or tape, adjacent one side of the urethra, to a position immediately beneath the abdominal wall. The tip of the tunneling device is located by palpating the tip through the abdominal wall and then making an incision at that point. The tape is then pulled through the incision and secured either external to the abdominal wall or subcutaneously. A similar procedure is performed to pass a second end of the tape around an opposing side of the urethra to a position adjacent a second location at the abdominal wall and similarly secured thereby forming a sling about the urethra.  
         [0008]     Occasionally, problems arise in identifying and locating the vaginal incision with the tip of the surgical instrument. Furthermore, in those patients having significant fatty deposits adjacent the abdominal wall, the usual method of locating the tip of the surgical instrument beneath the abdominal wall through palpation may not be possible.  
       SUMMARY  
       [0009]     The presently disclosed illuminated tunneling device generally includes an elongate tubular member and a stylet movably positioned within the elongate tubular member. At least a portion of the stylet is formed of a light transmissive material. In one embodiment, the entire stylet is formed of a light transmissive material. More particularly, at least a distal tip of the stylet is formed of a light transmissive material. In one particular embodiment, a portion of the distal tip is partially coated to block light transmission about a predetermined portion of the distal tip so as to facilitate the determination of the proper orientation of the surgical instrument within the body.  
         [0010]     The tunneling device is provided with a light guide for receipt of an external light source. The light guide communicates the external light source within interior of the elongate tubular member so as to illuminate the light transmissive distal tip of the stylet. In alternative embodiment, light be provided by a self-contained light source provided within a handle of the surgical instrument.  
         [0011]     The stylet generally includes a tip at the distal end which has a diameter greater than or equal to the inner diameter of the elongate tubular member. The stylet also includes a connection at its proximal end for receipt of a tape or suture. In one embodiment, the connection takes the form of a loop for receipt of the tape or suture. The loop is dimension to pass through the elongate tubular member so as to draw the tape through the elongate tubular member and thus through the body.  
         [0012]     In an alternative embodiment, the illuminated tunneling device includes a light pipe positioned between an interior of the-elongate tubular member and the stylet. The light pipe may be formed integral with the elongated tubular member or may be provided as a separate component.  
         [0013]     There is also disclosed a method of guiding a tunneling device through a body including the steps of providing a tunneling device having an elongate tubular member, a stylet movably positioned within the elongate tubular member, wherein at least the distal tip of the stylet is formed of light transmissive material, and a source of light for illuminating the distal tip of the stylet. The procedure further includes the steps of inserting the tunneling device through an incision formed in the vaginal wall and passing a distal end of the tunneling device into the body. The distal tip of the tunneling device is subsequently positioned adjacent an inner surface of the abdominal wall wherein the illuminated distal tip of the tunneling device is visible to the unassisted naked eye through the abdominal wall. Subsequent steps are taken to perform a conventional Intravaginal Slingplasty (IVS) tunneling procedure as disclosed in the U.S. Pat. No. 5,112,344. 
     
    
     DESCRIPTION OF THE DRAWINGS  
       [0014]     Various embodiments of the presently disclosed IVS tunneling device are disclosed herein with reference to the drawings, wherein:  
         [0015]      FIG. 1  is a perspective view of the presently disclosed IVS tunneling device;  
         [0016]      FIG. 2  is a perspective view of the tunneling device with the stylet separated from the remainder of the device;  
         [0017]      FIG. 3  is a partial view of the proximal end of one embodiment of the tunneling device illustrating a light guide port for the receipt of a light source;  
         [0018]      FIG. 4  is a partial view of the proximal end of another embodiment of the tunneling device containing a self powered light source;  
         [0019]      FIG. 5  is a cross-sectional view illustrating the light guide portion of the tunneling device for illuminating the stylet;  
         [0020]      FIG. 6  is a cross-sectional view of an alternative embodiment of the light guide portion of the tunneling device including a separate light pipe;  
         [0021]      FIG. 7  is a perspective view, partially shown in section, of the illuminated tip of the tunneling device illuminating, and being inserted through, an incision in the vaginal wall; and  
         [0022]      FIG. 8  is a perspective view, partially shown in section, with illuminated distal tip of the tunneling device being visible through the abdominal wall. 
     
    
     DETAILED DESCRIPTION  
       [0023]     Embodiments of the presently disclosed Intravaginal Slingplasty (IVS) tunneling device will now be described in detail with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views. As is common in the art, the term proximal refers to that part or component closer to the user or operator, i.e. surgeon or physician, while the term distal refers to that part or component further away from the user.  
         [0024]     Referring now to  FIG. 1 , there is disclosed one embodiment of an illuminated Intravaginal Slingplasty (IVS) Tunneling device  10  for use in inserting a tape or suture within the body of a patient. Tunneling device  10  generally includes an outer assembly  12  and a stylet  14  movably positioned within outer assembly  12 . At least a portion of stylet  14  is formed of a light transmissive material. Outer assembly  12  includes an elongate tubular member  16  and a handle  18  formed adjacent a proximal end  20  of elongate tubular member  16 . Handle  18  can take various shapes. In one embodiment, handle  18  is formed with a Delta wing shape.  
         [0025]     In the illustrated embodiment, a distal tip  22  of stylet  14  extends from a distal end  24  of elongate tubular member  16  and is formed of a light transmissive material. Distal tip  22  has a diameter that is greater than, or equal to, the inner diameter of elongate tubular member  16  such that distal tip  22  cannot be retracted within elongate tubular member  16 . A proximal end  26  of stylet  14  extends out of proximal end  20  of elongate tubular member  16 . In one embodiment, a loop  28  is formed at proximal end  26  of stylet  14  for receipt of a tape or suture. Loop  28  is dimensioned to be freely movable through elongate tubular member  16 .  
         [0026]     As shown in  FIG. 1 , elongate tubular member  16  includes a relatively straight proximal portion  30 , a distal portion  32 , and an arcuate portion  34 . The radius of arcuate portion  34  can be constant or variable depending upon the application of tunneling device  10 . Distal portion  32  can be either straight or arcuate. Furthermore, the plane defined by proximal portion  30 , distal portion  32  and arcuate portion  34  can be oriented at various angles relative to the plane defined by handle  18 .  
         [0027]     Referring now to  FIG. 2 , stylet  14  includes a relatively straight proximal portion  36 , a distal portion  38  and an intermediate portion  40 . Stylet  14  is formed of a flexible material and, as noted above, at least a portion of stylet  14 , including distal tip  22  is formed of a light transmissive material. In one embodiment, a portion  46  of distal tip  22  may be coated to block the transmission of light through coated portion  46  of distal tip  22 . In a particular embodiment, coated portion  46  is formed on the surface of distal tip  22  facing the outside arc of curvature of stylet  14 . By coating portion  46  of distal tip  22 , the orientation of tunneling instrument  10  within the body can be verified by observing the intensity of the light through the abdominal wall. For example, if tunneling instrument  10  is not in the proper orientation, coated portion  46  will block the transmission of light and will give the operator immediate visual feedback that tunneling instrument  10  is not properly oriented within the body and maybe traversing an undesired path through the body. By observing the intensity of the light emitted through tip portion  22 , the operator can reorient tunneling instrument  10  to its proper position.  
         [0028]     Stylet  14  can be formed such that intermediate portion  40  has an arcuate configuration. However, stylet  14  is sufficiently flexible such that it will pass through arcuate portion  34  of elongate tubular member  16  even if formed entirely straight.  
         [0029]     To assemble outer assembly  12  and stylet  14 , proximal end  26  of stylet  14  is inserted through an opening  42  in distal end  24  of elongate tubular member  16  and advanced through elongate tubular member  16  until proximal end  26  exits an opening  44  in proximal end  20  of elongate tubular member  16 . As noted above, the diameter of distal tip  22  of stylet  14  is equal to or greater than the inner diameter of elongate tubular member  16  such that tip  22  abuts distal end  24 .  
         [0030]     Referring now to  FIGS. 3 and 5 , a port or light guide  48  extends through handle  18  and elongate tubular member  16 . Light guide  48  is provided to receive an external source of light and communicate that light through handle  18  and into an interior of elongate tubular member  16 , such that the light thus transmitted is directed to stylet  14  to illuminate distal tip  22  of stylet  14 . In one embodiment, light guide  48  is formed as an integral part of elongate tubular member  16 . In this embodiment, it would be advantageous to form all of stylet  14  of a light transmissive material.  
         [0031]     Referring now to  FIG. 6 , there is disclosed an alternative light guide  50 . Light guide  50  generally includes a port  52 , similar to light guide  48 , and an inner tubular member  54  that is dimensioned to be positioned within elongate tubular member  16 . Further, inner tubular member  54  is also dimensioned to freely receive stylet  14  there through. Light guide  50  can be formed as an integral part of tunneling device  10  or can be configured to be removable. Port  52  is in optical communication with the interior of inner tubular member  54 . Inner tubular member  54  includes a distal portion  56  that extends partially or wholly to opening  42  of elongate tubular member  16 . Inner tubular member  54  further includes a proximal portion  58  that extends proximally to opening  44  of elongate tubular member  16 . In order to illuminate stylet  16  positioned within light guide  50 , an external source of light may be provided to port  52  or a proximal end of proximal portion  58 . In this embodiment, all or part of stylet  14  can be formed of a light transmissive material. However, it is desirable that at least distal tip  22  be formed of a light transmissive material.  
         [0032]     Referring to  FIG. 4 , in a further embodiment, tunneling device  10  is formed with a self-contained light source  60 . Light source  60  generally includes a source of power, such as, for example, a battery  62  and a source of light  64  (not explicitly shown) that is configured to illuminate the inside of elongate tubular member  16  and, therefore, distal tip  22  of stylet  14 . Light source  64  can take various forms, such as, for example, a conventional bulb, an LED light source, etc.  
         [0033]     Referring to  FIGS. 7 and 8 , the use of illuminated tunneling device  10  to perform a Intravaginal Slingplasty (IVS) procedure will now be described. Tunneling device  10  is prepared as described hereinabove with stylet  14  inserted into elongate tubular member  16 . A first free end of a tape or suture (not explicitly shown) is inserted through loop  28  at a proximal end of stylet  14 . An external source of light is connected to light guide port  48  or port  52  and turned on to illuminate the interior of the elongate tubular member  16 . In the various manners described hereinabove, this illuminates distal tip  22 . Alternatively, where tunneling device  10  is provided with a self-contained light source  60 , light source  60  will be turned on prior to insertion in the body.  
         [0034]     Initially, an incision (IV) is formed through the vaginal wall. Distal tip  22  of tunneling device  10  is inserted into the vaginal cavity such that distal tip  22  is positioned adjacent the incision. Notably, the supplied light illuminates distal tip  22  such that the light emitted therefrom can be used to identify the location of the vaginal incision. This significantly improves the ability of the operator to insert tunneling device  10  through the vaginal incision quickly and efficiently. Once distal tip  22  has passed through the vaginal incision, tunneling device  10  is manipulated to pass along one side of the urethra (U) and into the abdominal space. Once in position, distal tip  22  can be moved along the surface of the pubic bone (PB) such that the pubic bone (PB) acts as a guide to advance tunneling device  10  adjacent the abdominal wall (AW).  
         [0035]     Referring now to  FIG. 8 , as distal tip  22  is advanced toward the abdominal wall (AW), the light emitted by distal tip  22  will be visible to an unaided naked eye of the user. By being able to view the light emitted by distal tip  22  from external of the abdominal wall, the proper location for the abdominal incision can be determined. This is particularly significant in patients with significant fat deposits in the abdominal wall, which preclude the location of distal tip  22  by the usual palpation means. Further, depending upon the intensity of the light emitted by distal tip  22 , the entire path of distal tip  22  from the vaginal incision, through the retropubic space, and to a position located beneath the abdominal wall can be tracked.  
         [0036]     In the particular embodiment where a portion of distal tip  22  is coated to block light, the proper orientation of tunneling device  10 , as it is being passed through the body, can be maintained in a manner described hereinabove.  
         [0037]     Once the abdominal incision has been made, distal tip  22  is grasped and stylet  14  is pulled through elongate tubular member  16  to draw the tape attached to loop  28  through elongate tubular member  16  and out through the abdominal incision. Thereafter, outer assembly  12  is removed back through the intravaginal incision leaving the second free end of the tape extending through the vaginal canal.  
         [0038]     Tunneling device  10  is then used in a second procedure to loop the tape about the urethra (U) such that the second free end of the tape passes through a second abdominal incision (not shown). This procedure may be accomplished in one of several ways as best described in U.S. Pat. No. 5,112,344. The proper tension of the tape may be adjusted while the patient attempts to void. The tape may thereafter be secured subcutaneously and the abdominal incisions closed. Additionally, the vaginal incision is also suture closed. The tape may be left implanted in the body or may be removed after a sufficient period of time has elapsed allowing scar tissue to aid in supporting the urethra (U).  
         [0039]     Various modifications may be made to the embodiments disclosed herein. For example, the distal end of the elongate tubular member may be provided with a light transmissive portion or coating to facilitate placement of the tunneling device within the body. Further, the sources of light, and the manner in which the light is conducted to the distal tip of the stylet, can assume other configurations other than a single light port at a distal end of the instrument. Additionally, be disclosed illuminated tunneling device may be used in procedures other than Intravaginal Slingplasty procedures, including those where it would be advantageous to illuminate the entrance of the device into the body and monitor the passage of the device through the body. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.