Patent Publication Number: US-2013245661-A1

Title: Vaginal Stent and Method of Insertion

Description:
FIELD OF THE INVENTION 
     The field relates to vaginal stents and associated methods of using vaginal stents for bodily orifices. 
     BACKGROUND OF THE INVENTION 
     Stents for use in gynecological examination are known in the art but have been plagued by difficulty of use due to their geometry and other factors. 
     The deceased inventor of this specification, in writing a chapter for a medical treatise, entitled, “Pediatric Adolescent and Young Adult Gynecology,” described such known problematic stents for dilating the vaginal canal. For example, the Counseller stent, now no longer available, was a hard, plastic, torpedo-shaped stent which included a knob for protrusion through the vaginal orifice. This stent had many problems such as its length, excessive weight, and pressure on the vault apex. Yet another stent, the Jonas stent, included a round cross-section and a slight bottle shape with a knob. Its bottle shape helped aided in preventing expulsion and is easier for patients to handle. However, its round cross-section causes the stent to press on the bladder and may cause discomfort as well as increasing the chance of urinary tract infection. Additionally, the round cross-section also caused the stent to press on the section behind it, causing discomfort and a sensation of having stool in the rectum even after defecation. Patients also had to hold the stent and thus, the stent&#39;s use was limited to a few minutes. Yet another stent, a British stent made by the Rocket of London company is a flat teardrop-shaped stent made of a clear, hard, plastic, but did not include a handle. Although this stent is easy-to-use and is self-retaining, it was difficult to remove without drilling a hole into the neck of the stent. The inventor, by using that method, subsequently was able to remove the stent. 
     In the aforementioned treatise, the inventor further mentions various features of a potential stent, but without illustration or sufficient verbal detail so as to leave such teaching insufficient in various respects. 
     There remains a need for an improved vaginal stent which is more effective, easier to use and one that reduces pain and physiological harm to a patient. 
     SUMMARY OF THE INVENTION 
     In one example, a vaginal stent having a top and a bottom and includes from a proximal end of the stent to a distal end of the stent, a knob portion, a neck portion which adjoins a body portion in a shoulder region, and a body with a top surface and a bottom surface. 
     In the foregoing stent, a periphery of a cross section of the body is taken midway along the body along a longitudinal axis of the body, in a direction from the proximal end to the distal end of the stent, defining a flattened shape having a major axis and a minor axis. 
     The foregoing stent fulfills the need for an improved vaginal stent which is more effective, easier to use and one that reduces pain and physiological harm to a patient. 
     In one example, an associated method of using the vaginal stent includes the steps of first inserting the distal end of the stent into the a vaginal orifice of a human female with said major axis of the stent body being sufficiently angled from an approximately linear orifice of an empty vagina such that the knob avoids pressing a female urethra; further moving the stent backwardly into the vaginal canal until the neck portion becomes positioned at the vaginal orifice and the stent extending for a length into the vaginal canal such that the stent becomes locked in place by having the shoulders of the neck portion being self-retained and supported by levator ani muscles and fascia of the vaginal canal; and further positioning the stent such that the stent is substantially horizontally aligned with the transverse area of the vaginal canal by rotating of the knob. 
     The foregoing method of insertion facilitates an exemplary manner of using the stent while avoiding discomfort to the user during the insertion process. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Other features and advantages of the invention will become apparent from reading the following description in conjunction with the following drawings, which are drawn to scale, and in which like reference numerals refer to like parts: 
         FIGS. 1 and 2  are top and side views of one example of the vaginal stent of the present invention. 
         FIG. 3  is a rotated view of the vaginal stent of  FIG. 2 . 
         FIG. 4  is a cross-sectional view of the vaginal stent of  FIGS. 1 and 2  and surrounding anatomy of a female person when the stent is fully and properly inserted. 
         FIG. 5  is front view of the stent of  FIGS. 1 and 2 . 
         FIG. 6  is a cross-sectional view of the periphery of the stent body of  FIG. 1 , taken at the arrows marked  FIG. 6  in  FIG. 1  mid-way along a longitudinal axis of the stent body. 
         FIG. 7  is a simplified side view of stent  10 , showing modifications to curvatures of the neck portion. 
         FIG. 8  is a cross-sectional of an empty vaginal canal and surrounding anatomy of a female person. 
         FIGS. 9-11  are schematic, partial cross-sections at the respective depths into a vaginal canal at the arrows marked  FIG. 9 ,  FIG. 10 , and  FIG. 11  in  FIG. 8 , with each of  FIGS. 9-11  showing on the left an empty vaginal canal and on the right a vaginal canal with a non-cross-sectioned stent at a typical orientation during the process of inserting the stent into the vaginal canal. 
         FIG. 12  is a view of a posterior cut surface of the female pelvis in the area of the vagina and the uterus taken at the arrows marked  FIG. 12  in  FIG. 8 . 
     
    
    
     DETAILED DESCRIPTION 
     The examples and drawings provided in the detailed description are merely examples, and should not be used to limit the scope of the claims in any claim construction or interpretation. 
       FIGS. 1 and 2  show top and bottom views of a vaginal stent  10 , which is intended to be inserted into a vaginal canal of a female person for the purpose of dilating the vaginal to increase its size, for purposes in treatment, among other uses. 
     Before detailing features of the stent  10  of  FIGS. 1 and 2 ,  FIG. 4  shows the stent  10  inserted into a vaginal canal  13 , and the relation of the inserted stent to anatomical features such as a urethra  16  adjacent a top surface of the stent and a rectum  19 . Other anatomical features in  FIG. 4  and their relation to stent  10  will be described below. 
     Referring to  FIGS. 1 and 2 , stent  10  includes from the left-shown end to the right-shown end, a knob portion  21 , a neck portion  23  and a body  28 . As used herein, the left-shown end of the stent is referred to as the proximal end of the stent, and the right-shown end is referred to as the distal end of the stent. 
     Preferably, a transition depression portion  22 , such as a groove, is provided between the knob portion  21  and the neck portion  23 . Neck portion  23  includes a pair of shoulder regions  25  and  26 . A stent end portion  38  is shown. 
     Stent  10  may be made of plastic, acrylic, or SILASTIC-brand material, and combinations thereof, for example. Other materials for stents will be routine to those of ordinary skill in the art based on the present specification. 
     Stent body  28  is shaped to accommodate a vaginal canal. For instance, in a preferred embodiment, the distal end of body  28  is curved to match an inner surface of the vaginal canal, and neck  23  gradually decreases in width from body  28  to knob  21  to match the circumference of a vaginal canal, which is reduced at a lesser depth. 
     Transition Depression Portion 
     The preferred transition depression portion  22  assists gripping of the stent  10  by a person, for instance during insertion or removal from a vaginal canal. It also preferably conveys to the person gripping the stent the orientation of the stent relative to a vaginal canal, such as in which direction to top of the stent faces. As used herein and with reference to  FIG. 3 , the “top” of the stent  10  means that the face of the stent  10  adjacent to the urethra  16 , when the stent is properly and fully inserted into the vaginal canal, and the “bottom” of the stent means an opposite face of the stent adjacent to the rectum  19 , when the stent is properly and fully inserted. References herein to the “side” of the stent  10  mean a side of the stent connecting the top and the bottom of the stent. 
     Various preferred features of transition depression portion  22  are as follows. Region  22  preferably extends over at least 80 percent of the top and sides of the stent, such as shown in  FIGS. 1 and 2 . However, as shown in  FIG. 2 , it is preferred that the bottom of stent  10  be substantially free of transition depression portion  22 , where “substantially free” means that no more than about 20 percent of the bottom has a transition depression portion. This also aids in conveying to a person inserting the stent  10  into a vaginal canal the orientation of the stent, such as in which direction the top of the stent faces. 
       FIG. 3  illustrates a tilted view of the stent of  FIG. 2 , showing a top surface  50  and a bottom surface  52  of the stent and a shoulder region  26  of the stent. 
       FIG. 5  illustrates other preferred features of knob portion  21 . Preferably, the knob portion  21  is elongated in the top-to-bottom direction. Thus, knob portion  21  preferably has a top-to-bottom axis  30 , intersecting an axis  29  of the body (best seen in  FIG. 2 ), which exceeds a side-to-side axis  32  taken midway from top to bottom of knob portion  21 , by 30 percent, and more preferably by 40 percent. Preferably, as shown in  FIG. 4 , the majority of each of the left- and right-shown sides  35  and  37  are approximately linear and are tapered towards each other in a direction from top to bottom, as shown by tapered phantom lines leading to an angle  77 , which exceeds at least 6 degrees and may typically extend up to approximately 15 degrees. The foregoing elongated feature of the knob portion  21  and the tapering of the sides of the knob portion assist the user in identifying orientation of the vaginal stent  10  relative to the vaginal canal. 
     Dimensions and Shaping of Body 
       FIG. 6  shows a cross-section of stent body  10  of  FIG. 1 , taken mid-way along longitudinal axis  29  of the body. The cross-section shown in  FIG. 5  defines a flatted shape having a major axis  40 , which is approximately the largest left-to-right dimension in  FIG. 5 , and a minor axis  42 , which is preferably taken midway along the major axis  40  and is orthogonal to the major axis. One advantage of the flattened shape as shown in  FIG. 5  is that the shape is suitable to accommodate a corresponding flat transverse area of the vaginal canal. Variations on sizing, for example those for the flattened shape and cross-sectional areas of the stent, will be routine to a person of ordinary skill in the art as may be necessary, for example, in consideration of specific anatomy of a patient. 
     Referring to  FIGS. 2 and 6 , the length of stent  10 , along longitudinal axis  29  of the body, may be about twice as large as the major axis, or width  40  ( FIG. 5 ) of the stent. The minor axis  42  ( FIG. 5 ) of the stent may typically be from ⅛ to ½ of the length of the stent (i.e., left-to-right dimension in  FIG. 2 ). Selection of other dimension will be routine to persons of ordinary skill in the art based on the present specification. 
     In  FIG. 6 , the flatness of the illustrated cross-sectional shape of the body  21  is preferably defined by a top edge  45  of the body and a bottom edge  47  of the body, each centered about longitudinal axis  29  of the body and each having the length of the minor axis  42 , being linear to within 0.5 mm or, alternatively, within 1 mm of a straight line. 
     Additionally, as shown in  FIG. 2 , the majority of the top surface  50  of the stent body  28  along the direction of longitudinal axis  29  may be approximately linear, and the bottom surface  52  of the stent body  28  in the same direction may be relatively more convexly curved as shown. Of course, the top and bottom surfaces  50  and  52  of the stent body  28  may be modified to fit the vaginal canal of a person. 
     Persons of ordinary skill in the will find it routine to modify the stent described herein to properly fit a person&#39;s vaginal canal. Such modifications may include altering the shape, size, curvature, dimensions, and materials of all parts of the invention, and may also include providing a user with variously sized and shaped stents, for&#39;appropriate therapeutic relief. 
     Stent Accommodations of Anatomy 
     Various configurations of the stent  10  accommodate anatomical features, as now explained. Thus,  FIG. 2  shows the top surface of the neck portion  23  tapering from the body  28 , in a direction from the distal (or right-shown end) to the proximal (or left-shown end) of the stent  10 , towards the longitudinal axis  29  of the body. Such tapering avoids undue pressure on the urethra  16  ( FIG. 4 ) when the stent if properly and fully inserted into a vaginal canal. 
     As also shown in  FIG. 2 , the bottom surface of the neck portion  21  preferably tapers, in a direction from the proximal (or left-shown) end of the stent  10  to the distal (or right-shown) end of the stent, towards said longitudinal axis to avoid undue pressure on the rectum ( 19 ,  FIG. 4 ) when the stent is properly and fully inserted into a vaginal canal. 
       FIG. 7  shows a stent  10  with modifications to the curvature described in the foregoing three paragraphs, in which the numeral  60  shows an alternative upper neck contour, and numeral  62  shows an alternative lower neck contour. These alternative contours are among many alternative contours that may be used, as will be routine to persons of ordinary skill in the art depending on such factors as person anatomy, comfort, and ease of insertion. 
     Stents that lack the curvature described in the foregoing two paragraphs may result in undue pressure to the urethra and rectum as described. Such undue pressure causes discomfort to a person, and will likely reduce a person&#39;s willingness to continue treatment with the stent. Stents lacking the curvature described in the foregoing two paragraphs may also result in undue pressure to the urethra or rectum or both during the process of insertion and removal of the stent from a vaginal canal. 
     The curvature of neck portion  21  may be further modified as will be routine to a person of ordinary skill in the art as necessary, for example, in consideration of specific anatomy of a patient. 
     Insertion and Removal of Vaginal Stent 
     Aspects of the present invention also extend to methods of insertion and removal of the vaginal stents described above. To better understand these methods,  FIGS. 7-10  help explain preferred methods of insertion of a stent into a vaginal canal. 
     In particular,  FIG. 8  shows a vaginal canal  13  and adjacent anatomic organs, such as a urethra  16  and associated urinary bladder  17  above the vaginal canal  13 , and a rectum  19  below the vaginal canal. In  FIG. 8 , the arrows marked  FIG. 9 ,  FIG. 10  and  FIG. 11  show progressively different depths into the vaginal canal, which are respectively illustrated in  FIGS. 8-10 . 
     Thus,  FIG. 9  shows on the left a vaginal canal  13 , from outside the vaginal canal and the relative positions of the urethra  16  and the rectum  19 . The empty vaginal canal is shown closed, and is typically closed for the first in the first 2 cm of depth in a mature female person. The orifice, or opening, of the vaginal canal is shown with a generally linear orifice, which is vertically oriented in  FIG. 9 . Such generally linear orifice is referred to herein as an approximately linear opening. 
     The right side of  FIG. 9  shows the knob portion  21  of the stent inserted into vaginal canal  13  with its major axis ( 40 ,  FIG. 6 ) at a typical angle of 45 degrees from the approximately linear opening of the vaginal canal  13  as shown on the left of  FIG. 9 . This is to prevent undue pressure from the stent pressing on the urethra  16  during insertion or removal of the stent. Instead of the foregoing angle of 45 degrees, other angles, and preferably angles between 30 and 60 degrees, and more preferably angles between 40 and 50 degrees, can avoid undue pressure on the urethra. Thus, a first step of a preferred method of inserting a vaginal stent is to pass the distal end of a stent into the vaginal orifice at an angle according to the foregoing description. 
     The left side shown of  FIG. 10 , showing cross sections of  FIG. 8  at a greater depth into the vaginal canal  13  than the above-discussed  FIG. 9 , shows the vaginal canal  13  neither as linear in the illustrated vertical direction nor as linear in the illustrated horizontal direction, but more like a general circular shape that can assume different orientations when the vaginal stent is inserted into the vaginal canal, for instance. 
     On the right side of  FIG. 10 , the stent is shown in a typically further rotated position, in which the stent is at an angle of 60 degrees, for instance, from the illustrated vertical direction. The stent&#39;s rotation from the position shown in  FIG. 9  to the position shown in  FIG. 10  may be due to manipulation by a user, or at least partly or fully by self-rotation due to anatomical features such as the presence of the levator ani muscles of the pelvic floor, located in the vicinity of the stippled region  70 , more inwardly in the vaginal canal  13  than the cross section of  FIG. 10 . 
     On the left side of the progressively deeper cross section of  FIG. 8  shown in  FIG. 11 , the vaginal canal  13  is oriented mostly linearly in the illustrated horizontal direction. On the right side of  FIG. 11 , the stent is shown with the major axis ( 50 ,  FIG. 4 ) aligned with the illustrated horizontal direction. In this position, shoulders  25  and  26  of the stent are self-retained in the vaginal canal  13  due to support provided by pelvic floor muscles such as the levator ani muscles in region  70  ( FIG. 8 ) and associated fascia (not shown). 
       FIG. 12  further shows the levator ani muscles  71  and associated superior and inferior pelvic diaphragmatic fascia  73 , which supports the vaginal canal  13 , shown extending from a vaginal orifice at the bottom of the figure to a uterus  75 . As mentioned, it is the levator ani muscles  71  that retain the shoulders  25  and  26  ( FIG. 11 ) of the stent in position within the vaginal canal  13 . 
     Preferably, the stent is sized so that, when the shoulders  25  and  26  ( FIG. 10 ) of the stent are retained by the levator ani muscles  71  ( FIG. 7 ), approximately only the neck portion  21  and the transition depression portion ( 22 ,  FIGS. 1 and 2 ) protrude from the orifice of the vaginal canal  13 . For an adult female, this will mean that a typical length of about 8-10 cm of the stent protrudes into the vaginal canal  13 . This is a helpful guide for determining how deeply the stent should be inserted into the vaginal canal. 
     The shoulders of the stent help allow the stent to be self-retaining for several hours, in one example. 
     Without bound by theory, the vagina is attached laterally to the arcus tendineus fascia pelvis and to the levator ani muscle, which comprises three muscles, iliococcygygeus, puborectalis and pubococcygeus muscles. 
     Rotation of the stent from the position shown on the right of  FIG. 10  to the right of  FIG. 11  may occur by manipulation by a person or may occur at least partially or fully by self-rotation owing to the forces places on the stent by, for instance, the levator ani muscles  71  ( FIG. 12 ) located in region  70  of  FIG. 8 . 
     Removal of a stent from a vaginal canal occurs in one example (not illustrated), by placing an index finger and thumb around the knob portion with part of the finger and thumb preferably entering a transition depression portion, and then rotating the knob portion to dislodge the shoulders of the stent from the support given by the levator ani muscles and associated fascia, and pulling the stent out of the vaginal canal at preferably the same angles discussed above for insertion of the stent. 
     Benefits of Use of Vaginal Stent 
     The above-described stent is particularly useful for post-menopausal women who experience decreases in width and depth of the vaginal canal, and more particularly post-menopausal women who never had children. 
     The stent is also useful in dilating the vaginal canals of woman who undergo radiation treatment for cancer and who therefore need to use vaginal dilators regularly. 
     The stent may also be particularly helpful for women with congenital disorders. For example, women of all ages, who have congenital abnormalities in the formation of the vaginal canals, such as I-Rokitansky syndrome (MRKH syndrome) may use the stent in order to develop a vagina. If later surgery is required, the patient may use the vaginal stent post-operatively to maintain a state of the vaginal canal being open and to avoid secondary stricture. 
     The stent may also be used as vaginal dilators for women who have abnormally small vaginal canals, so as to avoid the need for surgery. 
     The stent is useful in reducing the spasms of women with vaginismus, and who experience severe pain and spasm of the vagina due to intense anxiety. 
     The stent can be used in gradually increasing sizes to help dilate the vagina and to avoid dyspareunia, or painful sexual intercourse. 
     The following is a list of reference numerals and associated parts as used in this specification and drawings: 
     
       
         
           
               
               
             
               
                   
               
               
                 Reference Numeral 
                 Part 
               
               
                   
               
             
            
               
                 10 
                 Stent 
               
               
                 13 
                 Vaginal canal 
               
               
                 16 
                 Urethra 
               
               
                 17 
                 Urinary bladder 
               
               
                 19 
                 Rectum 
               
               
                 21 
                 Knob portion 
               
               
                 22 
                 Transition depression portion 
               
               
                 23 
                 Neck portion 
               
               
                 25 
                 Shoulder region 
               
               
                 26 
                 Shoulder region 
               
               
                 28 
                 Body 
               
               
                 30 
                 Top-to-bottom axis 
               
               
                 32 
                 Side-to-side axis 
               
               
                 35 
                 Side 
               
               
                 37 
                 Side 
               
               
                 38 
                 Stent end 
               
               
                 40 
                 Major axis 
               
               
                 42 
                 Minor axis 
               
               
                 45 
                 Top edge 
               
               
                 47 
                 Bottom edge 
               
               
                 50 
                 Top surface 
               
               
                 52 
                 Bottom surface 
               
               
                 60 
                 Alternative upper neck contour 
               
               
                 62 
                 Alternative lower neck contour 
               
               
                 70 
                 Region of levator ani muscles 
               
               
                 71 
                 Levator ani muscles 
               
               
                 73 
                 Fascia 
               
               
                 75 
                 Uterus 
               
               
                 77 
                 Angle 
               
               
                   
               
            
           
         
       
     
     While the invention has been described with respect to specific embodiments by way of illustration, many modifications and changes will occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true scope and spirit of the invention.