Abstract:
A transilluminating rod used in laparoscopic hysterectomy has a cylindrical body made of light transmitting material like clear acrylic resin, substantially spherically shaped at the proximal end. An end terminal of predetermined shape and size to match an output connector of an external light source is disposed at the distal end of the rod. When inserted into the vaginal tract of a patient and firmly pressed against vaginal end wall the transilluminating rod brings into prominence a transilluminated and marked out fornix observed from inside of the body cavity through an endoscope. This allows for an easy identification of a cervico-vaginal junction enhancing prospects of safe dissection of a uterus.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims the benefit of PPA Ser. No. 60/578,358 filed Jun. 25, 2004 by Michael C. Hibner 
     
    
     FEDERALLY SPONSORED RESEARCH  
       [0002]     Not applicable  
       SEQUENCE LISTING  
       [0003]     None  
       FIELD OF THE INVENTION  
       [0004]     This invention relates to instruments used in laparoscopic surgery, specifically to instruments used to identify a cervico-vaginal junction of a patient during a total laparoscopic hysterectomy.  
       BACKGROUNG OF THE INVENTION  
       [0005]     In recent years, laparoscopy has become one of the foremost procedures in abdominal surgery, resulting decreased blood loss, infection rates as well as aesthetically pleasing effects. Also, the time for healing and consequently the length of patient&#39;s hospitalization is greatly reduced. Laparoscopy facilitates performance of a variety of surgical procedures of the abdomen, such as cholecystectomies, appendectomies, hernia repairs, hysterectomies and the like without requiring large incisions or the invasive procedures of conventional surgical techniques.  
         [0006]     The present invention is aimed specifically at providing an instrument to facilitate the technique of a total hysterectomy which is removal of the uterus. The main problem associated with that kind of laparoscopic surgical procedure is a reliable identification of the fornix as seen from inside of the body cavity.  
         [0007]     Many attempts were made to design and build instruments which would serve that purpose yet those instruments are not very common; in fact, there is not a single one that would be universally adopted and used by the surgeons. However, some inventions in this field might be considered as a related art to the present invention and will be briefly discussed.  
         [0008]     U.S. Pat. No. 6,572,631 discloses a transvaginal tube, which can be used at laparoscopic hysterectomy or other laparoscopic surgery involving insertion of the tube into vaginal tract of a patient. The proximal end of the tube is beveled and also angled to receive the cervix. The tube can be made of a transparent material to expose the vaginal epithelium through its walls. There is also a system of sealed ports and valves at the distal end of the tube to secure the pneumoperitoneum inside the body cavity. Among other purposes, an intra-abdominal tissue can be removed through these ports.  
         [0009]     U.S. Pat. No. 6,174,317 discloses an instrument for use in uterine laparoscopic surgery. Again, the body of the instrument has a form of an open tube; the proximal end of which is shaped to support against the top wall of the vagina. The instrument includes end closure means detachably fastened to the distal end of the tube; also, the inventors provided incisions at this end to anchor the suture. To maintain the pneumoperitoneum a sealing ring is provided between the tube and the wall of the vagina.  
         [0010]     U.S. Pat. No. 5,840,077 discloses an instrument with which a uterus can be manipulated during the laparoscopic hysterectomy. It includes an elongated shaft with a handle, an inflatable sleeve in the middle part which after being filled with air helps to maintain the pneumoperitoneum in the abdomen, an articulated joint, and finally close to the distal end there is a vaginal extender with a cup engaging patient&#39;s vaginal cervix to provide an anatomical landmark and backstop for making an incision at the fornix.  
         [0011]     U.S. Pat. No. 5,746,750 discloses an instrument specifically designed for manipulation of the uterus, in particular for laparoscopic complete hysterectomy. It comprises a handle at the proximal end of an elongated shank at distal end of which there is a manipulator probe and a claw to grip the cervix. Manipulation is done by tilting the probe around the pivot of the joint by means of an actuating screw. Also means are provided to seal the vagina in order to maintain the pneumoperitoneum.  
         [0012]     U.S. Pat. No. 5,394,863 discloses a light transmitting instrument made of an acrylic resin, used to transilluminate the vaginal fornix during the laparoscopic surgery. The body of the instrument has an elongated stem with a cup at the proximal end to engage the cervix. A light source is attached to the distal end of the instrument by means of a light cable. An additional aperture in the elongated body of the instrument can be connected to a suction pump to remove blood or to introduce a catheter when the instrument is used for hydrotubation.  
         [0013]     U.S. Pat. No. 5,131,380 discloses an illuminating instrument comprising a transparent semi stiff outer tube with a flexible light conductor inserted into said tube. The combination is intended to illuminate the body&#39;s cavities but was not specifically designated for laparoscopic surgery at uterus.  
         [0014]     The listed above inventions are cited here as most representative examples only and by no means exhaust the whole lot of instruments patented with the purpose of facilitating the total laparoscopic hysterectomy on mind.  
         [0015]     As already mentioned, the main problem associated with laparoscopic hysterectomy is an exact and reliable identification of the fornix and its surroundings as seen from above, that is from the direction of the body cavity. Surgeons skilled in the art of laparoscopic procedures at uterus and particularly the hysterectomy are very well aware of the problems that are awaiting them mainly the danger to cause damage to the bladder or other organs surrounding the uterus.  
         [0016]     An instrument or a tool designated to facilitate the hysterectomy should exhibit some few important features.  
         [0017]     First of all, it should be so built that when inserted into the patient&#39;s vagina it should help to mark out, seen as a kind of a bulge, an exact position of the fornix as observed from the inside of the body cavity through an endoscope. At the same time it should provide enough stretch to the tissues surrounding the cervix in order to make them thinner and to obtain more distance between the uterus and the organs surrounding it. The first two patents listed above that is U.S. Pat. No. 6,572,631 and U.S. Pat. No. 6,174,317 have a tubular shape beveled at the distal end to receive the cervix. When rotated, the tip of the tube is intended to exert pressure on the fornix and produce an imprint observed through an endoscope by the surgeon. U.S. Pat. No. 5,840,077 and U.S. Pat. No. 5,394,863 envelop the cervix with some kind of a cup what means that the pressure on the cervix is uniformly distributed. It should be appreciated, however, that the differences in women&#39;s anatomy both as regards the shape and the size of the generative organs preclude using one instrument that would fit all patients in all cases.  
         [0018]     Secondly, since the aforementioned feature is not fully sufficient to reliably define the outline of the cervico-vaginal junction some additional means should be employed. As it seems, the easiest and most reliable one is to additionally transilluminate the fornix. This should be facilitated by the fact that the instrument is capable of stretching the fornix so that it becomes more pliable to the penetration of light through it. Out of the above listed and briefly discussed patents only one that is U.S. Pat. No. 5,394,863 is specifically designed to transilluminate the fornix during the procedure of hysterectomy. Yet, as mentioned before, it has a fixed size cup at its distal end what precludes exerting a thrust on a particular part of the fornix. Since an instrument built around this idea has not yet been introduced to the market its usefulness cannot be evaluated.  
         [0019]     Also, when the instrument is inserted inside the vagina a proper level of pneumoperitoneum must be maintained during the surgical procedure. Some instruments disclosed in the above mentioned patents do not fulfill that condition in particular the instrument according to U.S. Pat. No. 5,398,863. Some instruments, discerned in other patents, are employing some kind of ports and valves for this purpose.  
         [0020]     There are, of course, other considerations that might be taken into account when discussing desirable features of the instrument like, for example, ease of sterilization, ease of handling, cost, etc.  
         [0021]     An idea for the invention had been borne in my mind during my fellowship in the Department of Gynecologic Surgery at Mayo Clinic, Scottsdale. There, in some surgical procedures like laparoscopic hysterectomy or colorectal procedures clear acrylic rods, colloquially referred to as Lucite rods (produced by Seelye Plastics), are used. These rods have a common length of 240 mm and different diameters. The biggest diameter is approx. 32 mm and the smallest approx 16 mm. Proximal, by what I mean closer to the patient&#39;s body, ends of these rods are shaped like a sphere, distal ends are flat. Inserted into the vagina during the laparoscopic surgery they were meant to stretch and define the position of the fornix during procedures like hysterectomy when decisions had to be made where to cut to dissect the cervix. When the thought to use light to transilluminate the fornix came to my mind I constructed an attachment to the rod comprising a sleeve and a strong flashlight with a four xenon LED light bulbs. The results were astonishingly good and the reliability as well as an ease of hysterectomy procedures I performed using the instrument considerably increased. Despite great improvement there were some drawbacks as well, one that the instrument was % a bit cumbersome as regards sterilization and a special method had to be applied to solve the problem. Also, the power of light source sometimes was not sufficient to contrast with the strong light from an endoscope which had to be switched off during the moment the incision was made.  
         [0022]     Later on I improved on the design and adapted the rod so, that an external light source could be directly connected to it. This second prototype is still under tests but preliminary results surpassed my expectations and I find its usefulness invaluable.  
         [0023]     Based on experience gathered during testing of my prototypes the objective of the present invention is to provide an instrument which would accomplish the following: 
        a) afford possibilities for stretching and marking out of the fornix for the purpose of clearly outlying position of the cervico-vaginal junction as well as securing more space between the uterus and the organs surrounding it,     b) ensure strong transillumination of the fornix from outside to make it distinctly seen from inside of the of the patient&#39;s body cavity even in a presence of light from an endoscope,     c) make use of commercially available endoscopic light sources,     d) ensure that the pneumoperitoneum is maintained during the surgical procedure,     e) enable easy sterilization and maintenance,     f) make handling of the instrument easy and the price affordable.        
 
       SUMMARY OF THE INVENTION  
       [0030]     In accordance with the present invention light from an auxiliary external source is provided to the distal end of cylindrically shaped transparent acrylic rod in order to identify and mark out position of a cervico-vaginal junction of a patient by the way of stretching and transilluminating a vaginal fornix during the laparoscopic total hysterectomy. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINS  
       [0031]      FIG. 1  is an oblique view of a clear acrylic rod used at Mayo Clinic being a Prior Art to the invention  FIG. 2  is an oblique view of a first prototype of the instrument produced by the inventor.  
         [0032]      FIGS. 3 and 4  are oblique views of transilluminating rods with integral end terminals.  
         [0033]      FIGS. 5 and 6  are oblique views of transilluminating rods with detachable end connectors.  
         [0034]      FIG. 7  is an oblique view of an instrument with opaque main body.  
         [0035]      FIG. 8  is an oblique view of a transilluminating rod with slide-over handle attached.  
         [0036]      FIG. 9  is an oblique view of a transilluminating rod with a screw-on handle attached.  
         [0037]      FIG. 10  is an oblique view of another embodiment of a transilluminating rod with a screw-on handle attached.  
         [0038]      FIGS. 11, 12  and  13  are oblique views of possible alternative shapes of proximal ends of the rods.  
         [0039]      FIG. 14  is a plan view of yet another embodiment of the transilluminating rod.  
         [0040]      FIG. 15  is a simplified side elevation sectional view of a woman&#39;s body showing the instrument in situ. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0041]      FIG. 1  shows an original rod  10  used at Mayo Clinic. It is made of transparent acrylic resin LUCITE with cylindrical body  11  spherically ended at proximal end  12  and as a flat plane at distal end  13 . There are four grooves  14  close to the distal end to obtain a more secure grip on the rod.  
         [0042]      FIG. 2  shows the first prototype of the transilluminating rod I built. It comprises rod  10  depicted in  FIG. 1 ., sleeve  21  and commercially available power torch  30  with four xenon light emitting diodes  32 . Sleeve  21  was made from an adapted PVC plumbing socket. There is a transition fit between the outer diameter of rod  10  and inside diameter  22  of sleeve  21  and the same kind of fit between inside diameter  23  of the sleeve and head  31  of flashlight  30 .  
         [0043]      FIGS. 3, 4 ,  5  and  6  show four concepts of feeding light from an auxiliary endoscope light source to the distal ends of transilluminating rods. All rods shown in the drawings are made of clear acrylic resin LUCITE, have cylindrical bodies like the original rod  10  and are spherically shaped at their proximal ends. Preferably, they also have a plurality of grooves at the distal end. It will be apparent, however, from drawings  11 ,  12  and  13  that proximal ends of the rods do not necessarily have to follow spherical shapes but can assume other forms as well. All transilluminating rods of my invention will have lengths in the range 300 to 450 mm, preferably 400 mm and diameters from 18 to 45 mm, preferably 35 mm.  
         [0044]      FIG. 3  shows a transilluminating rod  40  to which light from an endoscope cable will be fed to the distal end of the rod through end terminal  42  manufactured as one piece with cylindrical main body  41 . Terminal  42  has a form of a stud whose diameter, length and eventually position of groove  43 , if any, is such that it will match the type of a light cable output connector attached to it. End face  44  of stud  42  will be cleaved and polished. In the example shown the light cable output connector would be a DYONICS CLIP used, among others, in a STRYKER endoscope cable. This is a simplest form of a transilluminating rod, yet it has some drawbacks as well. One is that the stud can easily be broken off by careless handling. Besides, there are some types of endoscope cables with screw-on-terminals like for example a socket with an internal thread met, among others, in OLYMPUS endoscopes. To cut a fine pitch thread on a stud in a comparatively soft and brittle material would not be practicable if not impossible.  
         [0045]      FIG. 4  shows transilluminating rod  50 , which is my preferred embodiment and an idea of which was realized in my second prototype. The end terminal has a form of metal ferrule  60 , preferably produced of stainless steel. The ferrule is placed on stud  52  being an integral part with main body  51  of the rod, and secured in place with adhesive  55 . Stud  52  has an increased diameter  53  closer to main body  51  to match enlarged diameter of hub  61  of the ferrule. This makes the end terminal more robust and less pliable to breaking off. Different types of sleeves can be applied depending on the type of endoscope light sources available. In the example shown, ferrule  60  would match the STRYKER light cable output connector. Face  54  of the terminal is cleaved and polished.  FIG. 5  shows transilluminating rod  70  with detachable end connector  80 . Recessed hole  72  with an inner thread is made at the distal end of main body  71  of the rod. End connector  80  has a form of sleeve  81  with hole  82  passing through its length. Light guide  83  is inserted and secured inside hole  82  with an adhesive. Light guide  83  can be either made as a solid rod from the clear acrylic resin or, alternatively, a standard light conducting fiberoptic bundle can be used. Thread  84  on one end of sleeve  81  is made to match corresponding thread in recess hole  72 . The second end of sleeve  81  is an end terminal to receive an appropriate light cable output connector. The drawing shows thread  85  at the end of sleeve  81  matching, for example, an OLYMPUS endoscope cable. Both ends  86  and  87  of light guide  83  are cleaved and polished. Also, the bottom face  73  of hole  72  will be finished in the same way. Hole  72  will preferably be made deeper to accommodate filter  75 . Changed color of transilluminating light, for example to blue, will contrast with a bright white light coming out from a viewing endoscope and greatly enhance the process of identification of internal organs. Making an end terminal on the tool detachable has certain advantages. 
        (i) end connectors of different types can be used interchangeably with the same main body of the transilluminating rod.     (ii) when, after few times of being used, inevitable scratches and burns appear, only the main body has to be replaced what may be cheaper than replacing the whole tool.     (iii) a color filter can be easily applied.          
         [0049]      FIG. 6  shows transilluminating rod  90  with end connector  100 , based on the same principle as depicted in  FIG. 5 . The difference lays in the method of attaching end connector  100  to main body  91  of the rod. Recessed hole  92 , shaped like cone on part of its length, is made at the distal end of main body  91  of the rod. Sleeve  101  of end connector  100  also includes cone  102  matching the cone in hole  92 . Angles on the cones are such that the connection is self-locking. To disconnect the main body of the rod from the end terminal a special wedge-like prizing tool will be used. Filter  93  can also be placed at the bottom of hole  92 . Apart from the method of coupling, end connector  100  is made exactly in the same way as end connector  80  of  FIG. 5 . An advantage of this method can be that a smooth conical hole may be easier to produce and maintain than the threaded one.  
         [0050]     All transilluminating rods depicted so far had main bodies made of transparent acrylic resin. Transilluminating rod  110  shown in  FIG. 7  has main body  111  made of some kind of a medical grade opaque material. Insert  112  made of quartz glass or some other kind of hard light conducting material is embedded into main body  111  of the rod at the proximal end. Hole  113  with inner thread  114  at the distal end of body  111  is provided. End connector  120  is similar in built to end connector  80  shown in  FIG. 5 . It has a form of sleeve  121  with thread  123  by which it is connected to body  111 . The difference is in the length since sleeve  121  is extended with stem  122  transferring light through the entire length of the rod to the vicinity of end face  115  of insert  112 . Light guide  123  is composed of a fiberoptic bundle and has the length depending on the type of end terminal  120 . Both ends  125  and  126  of the light guide will be cleaved and polished. The end connector is also depicted here as one using thread  127  but as already mentioned it can be of any type depending on the type of light source being used. There are certain advantages to this embodiment, one, that a cheaper material can be used for the main body of the rod, two, that the tip at the proximal end of the rod is made of a much harder material what extends a life span of the tool.  
         [0051]     It has been found out that due to the slippery nature of the rod, even in the presence of grooves like  14  shown in  FIG. 1 , manipulating the tool in a patient&#39;s vagina is sometimes hampered and some kind of a handle would be of assistance.  
         [0052]      FIG. 8  shows transilluminating rod  40  with an auxiliary slide-over handle  130  attached. Body  131  of handle  130  will be preferably made of some kind of a cheaper grade plastic material. Screw  132  locks the handle on the tool. Other types of handles of known art can be used, specifically, universal handles capable of engaging rods of different diameters.  
         [0053]      FIG. 9  shows transilluminating rod  140  with an auxiliary screw-on handle  150  attached. Threaded cylinder  142  is provided at the distal end of the main body  141  of the rod just before end terminal  143 . It will be appreciated that end terminal  143  not necessarily has to be of the type shown in the drawing but can be any of the types described before and shown in drawings  FIGS. 3, 4 ,  5 ,  6  and  7 . Handle  150 , preferably made from stainless steel, has threaded hole  151  to match thread on cylinder  142 . Threaded cylinder  142  will have the same size in rods of different diameters so that the same handle can be used for all. Transilluminating rod  140  can be also used independently that is with handle  150  detached.  
         [0054]      FIG. 10  shows transilluminating rod  160  being my second preferred embodiment. Handle  170  is detachable but is an integral part of the tool. Threaded cylinder  162  is provided, similarly as in transilluminating rod depicted in  FIG. 9 , at the distal end of main body  161 . Cylinder  162  will be preferably recessed on face  163  to accommodate filter  164 . Handle  170  made preferably of stainless steel includes hub  171  with two coaxially displaced and mutually connected threaded holes  172  and  173 . Thread inside the first of these two holes matches the thread on cylinder  162  by which handle  170  is attached to main body  161 . Second threaded hole  173  serves as housing for detachable end connector. Shown in the drawing is connector  80  depicted in  FIG. 5 . The most important advantage to this embodiment is that all component parts of the tool are interchangeable.  
         [0055]     It has to be noted that methods of connections of parts in some embodiments are shown as exemplifications only and should not be construed as limitations to the scope and specificities of these embodiments. Any known in the art of engineering methods of fastening or coupling can be equally applied.  
         [0056]     Proximal ends of all transilluminating rods depicted so far had one feature in common namely that they were shaped like a regular sphere. Although this will be a preferred configuration, it will be appreciated that in some instances, depending on anatomical conditions of a patient, type of an operation, etc. other shapes of proximal ends of transilluminating rods can be of advantage.  
         [0057]      FIG. 11  shows the two-stepped transilluminating rod with main body  181  reduced in size to cylinder  182  of smaller diameter and ended like a sphere at proximal end  183 . There is transition surface  184  between these two which may assume shape of a straight or concave cone.  
         [0058]      FIG. 12  shows the proximal end of a transilluminating rod with main body  191  flaring out to form an enlarged head with spherically shaped proximal end  192 . Again, the transition surface  193  between these two may assume a conical shape of any type.  
         [0059]     In  FIG. 13  another possible form of the proximal end of a transilluminating rod is shown. Main body  201  of the rod makes a transition through surfaces  202  on the outside and a concave surface  203  on the inside to a bean-shaped proximal end  204 .  
         [0060]      FIG. 14  shows a different concept of transilluminating rod  210  in which light is not supplied from an external source but is generated inside the tool. It is envisaged that all constituent parts of the tool will be contained inside completely sealed body  211  made from some kind of medical grade material. The tool comprises laser diode  215 , electronic circuit  216 , rechargeable battery  217  and proximal switch  218  enabling the light to be switched on and off; Terminals  219  sealed in distal end  214  of the rod will be used to recharge the battery. Light conducting plate  212  is hermetically closing the interior of the tool close to the proximal end. Insert  213  made from some kind of light transmitting material like quartz glass can be made detachably fixed at the tip of proximal end of the tool.  
         [0061]      FIG. 15  shows a simplified cross-section through woman&#39;s body with tool  220  in situ, comprising transilluminating rod  50  with handle  130  attached. Light is delivered to end connector  60  at the distal end of the rod through output connector  231  of light cable  230 . Another end of the light cable is connected to an auxiliary endoscope light source not shown in the drawing. Tool  220  is inserted into patient&#39;s vagina then pressed firmly against fornix  221  and transilluminated by beam of light  222  coming out from the proximal end of rod  50 . Position of cervix  223  is revealed clearly showing the surgeon where to make an incision with schematically marked tool  224 . Also, schematically marked is the end of endoscope  225  illuminating the body cavity from inside.