Abstract:
An apparatus for treating tissue, comprising a sheath defining a lumen sized and shaped to receive a treatment device therein, a guide member coupled to the sheath and extending a predetermined distance substantially parallel to a longitudinal axis of the sheath, and a stabilizer element for engaging an anchoring device coupled to tissue to stabilize the sheath and the treatment device, the stabilizing element being movably coupled to the guide member for movement therealong substantially parallel to the longitudinal axis of the sheath wherein, when in a proximal-most position, the stabilizer element is located proximally of a proximal end of the guide member.

Description:
PRIORITY CLAIM 
     This application claims priority to U.S. Provisional Application Ser. No. 60/971,409, entitled “Tenaculum Stabilizer Device,” filed Sep. 11, 2007. The entire disclosure of the above-identified application is incorporated herewith by reference into this application. 
    
    
     BACKGROUND INFORMATION 
     During procedures that require the insertion of a device through the cervix into the uterus, it may be necessary to seal the cervical opening to prevent fluids, gases etc. introduced into the uterus from escaping into the vagina. If such a device is prematurely withdrawn from the uterus (i.e., if a distal tip of the device is moved proximally beyond the cervical os), fluids and/or gases may be introduced into the vagina. Thus a tenaculum may be used to lock the device in place and prevent such premature withdrawal. 
     For example, if the lining of the uterus is to be ablated using heated fluids inserted into the uterus via a device inserted through the cervix, it is important to prevent the heated fluids from damaging vaginal tissue. An exemplary system for such treatment is the Hydro ThermAblator® system (HTA) manufactured by the Boston Scientific Corporation. 
     SUMMARY OF INVENTION 
     This application relates to an apparatus for treating tissue, comprising a sheath defining a lumen sized and shaped to receive a treatment device therein. A guide member is coupled to the sheath and extends a predetermined distance substantially parallel to a longitudinal axis of the sheath. A stabilizer element for engaging an anchoring device of the apparatus of the present invention is coupled to tissue to stabilize the sheath and the treatment device, the stabilizing element being movably coupled to the guide member for movement therealong substantially parallel to the longitudinal axis of the sheath wherein, when in a proximal-most position, the stabilizer element is located proximally of a proximal end of the guide member. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG. 1  shows a side view of a conventional tenaculum stabilizer; 
         FIG. 2  is a side view of a tenaculum stabilizer according to an embodiment of the present invention; 
         FIG. 3  is a detail view of a positive stop of the tenaculum stabilizer shown in  FIG. 2 ; 
         FIG. 4  shows a side view of a hydro thermal ablation system including a tenaculum stabilizer according to a further embodiment of the invention; 
         FIG. 5  shows a perspective view of a scope adapter for use with the system of  FIG. 4 ; 
         FIG. 6  shows a tenaculum stabilizer arrangement according to an alternate embodiment of the invention; 
         FIG. 7  shows a side view of the tenaculum stabilizer arrangement of  FIG. 6 ; 
         FIG. 8  shows a tenaculum stabilizer arrangement according to a further embodiment of the invention; 
         FIG. 9  shows a side view of the tenaculum stabilizer arrangement of  FIG. 8 ; 
         FIG. 10  shows a tenaculum stabilizer arrangement according to a still further embodiment of the invention; and 
         FIG. 11  shows a tenaculum stabilizer arrangement according to a still further embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention may be further understood with reference to the following description and to the appended drawings, wherein like elements are referred to with the same reference numerals. The present invention relates to devices for stabilizing surgical instruments and, more specifically, relates to devices for stabilizing a tenaculum during procedures within the uterus. 
     After the distal tip of a sheath of a system such as the HTA system has been inserted into the uterus via the cervix, one or more tenaculums may be employed to enhance the cervical seal to prevent heated liquids from leaking out of the uterus and damaging non-targeted tissue (e.g., vaginal tissue). A tenaculum stabilizer allows the tenaculum to be used to stabilize the sheath by countering forces applied thereto as instruments are inserted through the sheath. This reduces the likelihood that the sheath will be inadvertently pulled out of the cervix. According to the exemplary embodiments of the invention, a novel stabilizer for the tenaculum is provided to further aid in stabilizing the sheath within the cervix while minimizing interference between the stabilizer and the proximal end of a hysteroscope inserted through the sheath. 
     As will be described in more detail below, a tenaculum stabilizer  100  according to an exemplary embodiment of the invention is designed to work in conjunction with an HTA system or, as would be understood by those of skill in the art, any of a variety of different devices for a wide range of procedures. For example, a tenaculum stabilizer according to the present invention is useful for any procedure in which a device must be inserted into any body cavity and for which it is desired to prevent the premature withdrawal of the device therefrom. Such procedures include, among others, all ablation procedures such as cryogenic, thermal and chemical ablation systems. The tenaculum stabilizer  100  is compatible with currently used tenaculums and, in particular, with those having a length of between about 22.86 and 25.4 cm. as are commonly used in HTA system procedures. As described below, the stabilizer  100  may preferably be made compatible with a wide range of hysteroscopes such as those manufactured by Olympus, Wolfe, ACMI, Karl Storz, etc. which are of different lengths and diameters. As would be understood by those skilled in the art, when a scope is inserted to a desired position within the uterus, the length of the scope extending proximally from the sheath will vary depending on the total length of the scope. The shorter the scope is, the closer the proximal handle of the scope will be to the proximal end of the sheath. The position of the tenaculum stabilizer is then adjusted to lock it against a cross bar or within a thumb loop of the tenaculum to immobilize the sheath relative to the tenaculum. 
     In contrast,  FIG. 1  shows a conventional HTA system  10 , including an insertion sheath  12  extending from a proximal scope insertion end  14 , to a distal end (not shown) which is inserted into the uterus via the cervix. Those skilled in the art will understand that a cap  16  is removed from the scope insertion end  14  and a hysteroscope (not shown) is inserted through the sheath  12  until a distal end of the scope extends into the uterus for supply and withdraw ablation fluids. The HTA system  10  further includes an inflow/outflow tubing  18  and a tenaculum stabilizer arrangement  20  mounted thereon. The tenaculum stabilizer arrangement  20  includes a guide member  22  mounted on the sheath  12  adjacent to the inflow/outflow tubing  18  and a stabilizer element  24  slidably mounted on the guide member  22 . In this embodiment, the guide member  22  forms a track on which the stabilizer element  24  slides to allow for adjustments in the position of the stabilizer element  24  relative to a part of the tenaculum against which the stabilizer element  24  is to be locked to prevent the sheath  12  and the hysteroscope from being inadvertently withdrawn from the uterus. As would be understood by those skilled in the art, the stabilizer element  24  is slidable back and forth over guide member  22  to permit adjustment of the stabilizer arrangement  20  to allow for different tenaculum lengths and tensions. In order to account for the varying position of the feature of the tenaculum against which the stabilizer element  24  is to be locked and/or varying tensions to be applied thereto, the track of the guide member  22  is approximately 9.35 cm. long to allow for a total range of motion of the stabilizer element  24  of 3.38 cm. Thus, the entire range of motion of the stabilizer element  24  is accounted for by the length of the guide member  22 . However, as the length of the portion of the scope within the sheath  12  is constant, the portion of the scope extending from the proximal scope insertion end  14  of the sheath  12  varies depending on the length of the scope with control handles of shorter scopes remaining closer to the scope insertion end  14  than control handles of longer scopes. The control handle portions of these scopes are wider than the insertion portions, extending radially outward, in some cases, as far as a radially inner surface of the guide member  22 . Thus, for shorter scopes, the control handle will be closer to the scope insertion end  14  and, consequently, to the guide member  22 . This may result in the rotation of the scope being interfered with or prevented by the portion P of the guide member  22  extending proximally of the scope insertion end  14  of the sheath  12 . 
     As shown in  FIGS. 2-5 , a novel HTA system  100  includes a tenaculum stabilizer arrangement  102  according to the invention. The stabilizer arrangement  102  comprises a fin-shaped stabilizer element  104 . However, those skilled in the art will understand that other shapes may be used. For example, the stabilizer element  104  may be hook shaped or grooved, or may have any other shape that facilitates attachment to a cross bar, finger loop or body of a tenaculum. 
     For example, as shown in  FIGS. 6 and 7 , an alternative stabilizer arrangement  300  includes a pair of arms  304  extending outward from a portion of a sheath  306  extending distally from a proximal end including a scope adapter  307  (described in more detail below) to engage finger loops of a tenaculum. Each of the arms  304  is pivotally connected to the sheath  306  at a hinge  308  and biased toward the sheath  306  by a spring  310  so that, after the finger loops of the tenaculum have been passed over ends of the arms  304 , the bias of the springs  310  draws the arms  304  into engagement with corresponding braces  312  to lock the tenaculum to the sheath  306 .  FIGS. 8 and 9  show a stabilizer arrangement  400  according to a further embodiment of the invention including a plurality of projections  402  spaced from one another and extending along the body of a sheath  404  so that a cross bar  406  of a tenaculum  408  can be slid over a desired one of the projections  402  to lock the tenaculum in any of a plurality of desired positions—e.g., to achieve a desired tension. In addition,  FIG. 10  shows a stabilizer arrangement  500  according to a further embodiment of the invention including a Velcro strap  502  extending along a portion of the length of a sheath  504  for securing to the sheath a cross bar or other structure of a tenaculum in a desired position relative to the sheath. 
     The exemplary tenaculum stabilizer arrangement  102  may be connected to a device to be inserted through the cervix in various ways. For example, the stabilizer arrangement  102  may be permanently connected to a sheath handle  110  of the HTA system  100  as an integral component of the HTA system  100  or, alternatively, may be formed as a separate device connected to the sheath handle  110  during preparation for an ablation procedure. 
     In the exemplary embodiment, the tenaculum stabilizer arrangement  102  is mounted on the sheath handle  110  of the HTA system  100  via a stabilizer track  105  attached to the sheath handle  10  with a sheath  108  extending distally from the handle  110 . A stabilizer element  104  includes an elongated rail  106  sliding along the stabilizer track  105  which is significantly shorter than the guide member  22  of the system  10  shown in  FIG. 1 . The lengths of the rail  106  and the track  105  are selected to, in combination, provide a desired range of motion necessary to accommodate various models of hysteroscope including any accessories such as light and fiber optic bundles of the scope. For example, the distance between the tip of the sheath  120  and the distal end of the stabilizer arrangement  102 , or more precisely, a distal end  107  of the stabilizer track  105 , is a known constant value short enough to accommodate the shortest scope anticipated. For example, it may be desired to select the lengths of the track  105  and the rail  106  so that, when in a fully extended position, the proximal extension P′ of the rail  106  from the handle  110  may be approximately equal to the proximal extension of the guide member  22  of the system  10  of  FIG. 1 . However, when the stabilizer element  104  and the rail  106  are moved distally from this position, the proximal extension of the rail  106  is reduced compared to that of the guide member  22 . Thus, depending on the position of the feature of the tenaculum against which the stabilizer element  104  is to be locked, the extension of the rail  106  may be reduced to permit free rotation of the control handle of even shorter scopes which would be interfered with by the guide member  22  of the system  10  of  FIG. 1 . Thus, the stabilizer element  104  can be cantilevered out proximally from the proximal end of the rail  106  so that, when the stabilizer element  104  is not in the proximal-most position, the proximal end of the rail  106  does not extend as far proximally as the guide member  22  of the conventional system. As would be understood by those skilled in the art, the track  105  may alternatively be shortened and coupled to a stabilizer element extending proximally therefrom—i.e., with the stabilizer element located proximally of the proximal end of the track  105 . 
     In addition, the stabilizer arrangement  102  may include a mechanism ensuring that the stabilizer element  104  is not inadvertently removed from the track  105 . For example, in this embodiment a positive stop  112  formed as a catch protruding from the rail  106  and abutting one or more corresponding abutting features  114 ,  116  of the track  105 . Those skilled in the art will understand that the features  114 ,  116  may comprise protrusions, detents or other discontinuities in the stabilizer track  105  which engage the positive stop  112  when a desired maximum travel of the stabilizer element  104  in a given direction has been reached. The location of the positive stop  112  is preferably selected to accommodate tenaculums of various dimensions and to permit a desired range of tensioning thereof. 
     The tenaculum stabilizer arrangement  102  may be manufactured from any of a variety of flexible plastic materials or combinations of such materials. For example, the device may be made of ABS, polyethylene or delrin. In addition, the stabilizer element  104  and/or the stabilizer track  105  may be coated with a low friction material, to ease the sliding movement of the rail  106  on the stabilizer track  105 . Those of skill in the art will understand that various other plastic and non-plastic materials may be used in the manufacture of the tenaculum stabilizer device according to the invention. 
     As shown in  FIGS. 4 and 5 , an HTA system  200  according to a further embodiment of the invention includes a handle  210  coupled to a proximal end of an HTA sheath  212  with a scope adapter  214  telescoping in and out of a proximal end of the handle  210 . The telescoping scope adapter  214  accommodates scopes of various sizes and designs, as described above by extending proximally as needed to support the control handle of the scope and accommodating closely the diameter of the scope. That is, for longer scopes, a significant portion of the length may extend out of the proximal end of the handle  210  and, if left unsupported, this extending portion of the scope may move about in an undesired manner. To prevent this, a user depresses a scope adapter button  216  releasing the adapter  214  from a frame  218  of the handle  210  and slides the adapter  214  until a proximal end of the adapter  214  is separated from the proximal tip of the sheath  212  by a distance selected to enclose a desired portion of the length of the scope. The button  216  is then released to pop outward (e.g., under spring bias) into one of a plurality of locking holes  220 , preventing the adapter from moving relative to the handle  210 . When in a desired position, the adapter  214  supports the extending portion of the scope (e.g., up to a distal end of the control handle). Furthermore, a scope adapter locking ring  222  may then be rotated to cinch an inner lumen of the adapter  214  around the scope to prevent liquid from passing through the handle  210  and out the proximal end thereof. 
     Similarly to the embodiments described above, the HTA system  200  includes a tenaculum stabilizer arrangement  230  including a stabilizer element  236  slidably mounted on the handle  210  of the HTA system  200  via a stabilizer track  232  attached to the handle  210 . The stabilizer element  236  includes an elongated rail  234  sliding along the stabilizer track  232  which, similar to that of the device of  FIGS. 2 and 3 , is significantly shorter than the guide member  22  of the system  10  shown in  FIG. 1 . As with the previously described embodiment, the lengths of the rail  234  and the track  232  are selected to, in combination, provide a desired range of motion necessary to accommodate various models of hysteroscope including any accessories such as light and fiber optic bundles of the scope. For example, the distance between the tip of the sheath  212  and the distal end of the stabilizer arrangement  230 , or more precisely, a distal end  238  of the stabilizer track  232 , is a known constant value short enough to accommodate the shortest scope anticipated. For example, it may be desired to select lengths of the track  232  and the rail  234  so that, when in a fully extended position, the proximal extension of the rail  234  from the handle  210  may be approximately equal to the proximal extension of the guide member  22  of the system  10  of  FIG. 1 . However, when the stabilizer element  236  and the rail  234  are moved distally from this position, the proximal extension of the rail  234  is reduced compared to that of the guide member  22 . Thus, depending on the position of the feature of the tenaculum against which the stabilizer element  104  is to be locked, the extension of the rail  234  may be reduced to permit free rotation of the control handle of even shorter scopes which would be interfered with by the guide member  22  of the system  10  of  FIG. 1 . 
     In addition, the sheath  212  includes, at a distal end thereof, a cervical seal  240  which is formed, for example, as a mesh  242  covered by a sheath of flexible material with a proximal end of the mesh abutting a sleeve  244  which is movable axially within the sheath  212 . For example, the sleeve  244  of this embodiment is coupled to a seal actuator  246  which, when rotated relative to the sheath  212  in a first direction moves the sleeve distally to axially compress the mesh  242  and, when rotated in the opposite direction, moves the sleeve proximally. When axially compressed (e.g., between the sleeve  244  and the distal end of the sheath  212 ), the mesh  242  expands radially away from the sheath  212  to form an expanded distal end of the sheath  212  which may be drawn proximally against the cervical os to enhance the seal of the uterus. 
       FIG. 11  shows another exemplary embodiment of an HTA system  600  according to the present invention. Similarly to the system  200  described above, the HTA system  600  includes a tenaculum stabilizer arrangement  230  including a stabilizer element  236  slidably mounted on a handle  210  via a stabilizer track  232 . The stabilizer element  236  includes an elongated rail  234  sliding along the stabilizer track  232  which, similar to that of the device of  FIGS. 2 and 3 , is significantly shorter than the guide member  22  of the system  10  shown in  FIG. 1 . The stabilizer element  236  may be moved along the track  232  by pulling the element  236  proximally allowing a ratcheting surface  270  of the stabilizer element  236  to slide over angled teeth  280  disposed along the track  232 . As would be understood by those skilled in the art, distal surfaces of the ratcheting surface  270  and the teeth  280  are preferably both angled substantially parallel to one another extending proximally in a direction away from the track  232  so that the ratcheting surface  270  rides up and over the teeth  280  as the stabilizer element  236  is moved proximally. Distal surfaces of the ratcheting surface  270  and the teeth  280  are preferably substantially perpendicular to a longitudinal axis of the track  232  so that distal movement of the stabilizer element  236  over the track  232  is prevented by contact between the ratcheting surface  270  and the teeth  280 . The stabilizer element  236  may be moved distally over the track  232  by bending the stabilizer element  236  proximally, rotating the ratcheting surface  270  out of engagement with the teeth  280 . The HTA system  600  also differs from the previously described embodiments in that one or more positive stops (not shown) are located within an internal surface of the rail  234 , rather than externally as with the stop  112 . The internal positive stop prevents the rail  234  from being removed from the track  232  and similarly to the stop  112 , forms a catch which abuts a protruding feature (not shown) located at a proximal and/or a distal end of the track  232  such that movement of the stabilizer element  236  is confined to sliding between the proximal and distal ends of the track  232 . 
     The present invention has been described with reference to specific exemplary embodiments. Those skilled in the art will understand that changes may be made in details, particularly in matters of shape, size, material and arrangement of parts. Accordingly, various modifications and changes may be made to the embodiments. For example, the exemplary devices described may be used to perform ablations of the lining in other bodily cavities or hollow organs other than the uterus. The specifications and drawings are, therefore, to be regarded in an illustrative rather than a restrictive sense.