Abstract:
A vaginal delineator, capable of adjusting to varying lengths of the cervix and angles of the fornix is disclosed. A diaphragm for occluding the vagina, preventing leakage of carbon dioxide from the peritoneal cavity is attachable to the delineator. In an additional embodiment, the vaginal delineator comprises a cup to which a ring is pivotally attached. In this embodiment, the cup acts as the occlusion device.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     Not applicable.  
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
       [0002]     Not applicable.  
       REFERENCE TO MICROFICHE APPENDIX  
       [0003]     Not applicable.  
       BACKGROUND OF THE INVENTION  
       [0004]     1. Field of the Invention  
         [0005]     The present invention relates generally to a medical device. More particularly the present invention relates to a vaginal occlusion and self-adjusting delineation attachment for use in a uterine mobilizer.  
         [0006]     2. Background Art  
         [0007]     Conventional hysterectomy surgical procedures typically involve one of four approaches: vaginal hysterectomy, total abdominal hysterectomy (TAH), total laparoscopic hysterectomy (TLH), and laparoscopically assisted vaginal hysterectomy (LAVH). Vaginal, TLH and LAVH have become more popular among surgeons because these approaches are less invasive than TAH, with TLH being the least invasive approach. TLH is less invasive than LAVH because it avoids the trauma normally caused by the expansion induced to the vaginal area to permit access of the surgeons hands to the cervical area. Unless medical indications require TAH (such as in the case of tumor removal and the associated need to avoid cell spillage), vaginal, TLH and LAVH are usually viewed as more preferable because each is less invasive when compared to major abdominal surgery. Thus, TLH and LAVH approaches usually result in shorter hospitalization and recovery times.  
         [0008]     Difficulties arise in TLH and LAVH, however, in identification when the vagina is not well delineated. Another technicality is leakage of carbon dioxide from the peritoneal cavity when the vagina is opened laparoscopically.  
         [0009]     Another problem, not appropriately addressed in the prior art, is that human bodies vary considerably. Any vaginal insertion device for surgical procedures must, therefore, be adjustable. Such devices are, preferably, self-adjusting.  
         [0010]     There is therefore a need for a vaginal delineation device, attachable to a uterine mobilizer, that also provides occlusion to the vagina to disallow leakage of carbon dioxide. There is a further need for a vaginal delineation and occluding device that is adjustable, and as self-adjusting as possible.  
       BRIEF SUMMARY OF THE INVENTION  
       [0011]     An object of the present invention is to provide a vaginal delineator for use in female pelvic surgical procedures that attaches to a uterine mobilizer, such as the Valtchev Uterine Mobilizer, and is self adjusting to various lengths of cervixes and angles of fornices.  
         [0012]     The present invention is a device that inserts and locks into a uterine mobilizer, the device comprises a ring that adjusts in angle. The ring is made to bear against the vaginal fornix, conforming to its angle and providing delineation of that part of the vagina for identification thereof.  
         [0013]     In a second embodiment, the ring is also self-adjusting as to distance from the uterine mobilizer, to accommodate varying lengths of the cervix. This is effected by pivotally mounting the ring onto four telescopic rods or legs, all spring loaded.  
         [0014]     A third embodiment of the present invention is configured like a cup with a rigid ring, pivotally attached at the top of the cup. Again, the pivotal attachment provides accommodation for varying angles of the fornix.  
         [0015]     Another object is to provide an occluder to prevent leakage of carbon dioxide from the peritoneal cavity when the vagina is opened laparoscopically. An enlarged portion of an extension at the base of the vaginal delineator, said extension being inserted into the uterine mobilizer, is made to receive a diaphragm made of an elastic material such as plastic, silicon, nylon, etc. The diaphragm obstructs the vaginal cavity toward the outside of the vaginal delineator, preventing leakage of carbon dioxide from the peritoneal cavity.  
         [0016]     In the third embodiment of the invention, the cup is the occluding apparatus as well as the structure on which the variable-angle, rigid ring is mounted.  
         [0017]     Other objects, advantages and novel features of the present invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS  
       [0018]      FIG. 1  is a side elevation view of a uterine mobilizer and a vaginal delineating and occluding device;  
         [0019]      FIG. 2   a  is a first side elevation view of the vaginal delineating and occluding device;  
         [0020]      FIG. 2   b  is a plan view from the top of the vaginal delineating and occluding device;  
         [0021]      FIG. 2   c  is a second side elevation view of the vaginal delineating and occluding device;  
         [0022]      FIG. 2   d  is a plan view from the bottom of the vaginal delineating and occluding device;  
         [0023]      FIG. 2   e  is a side elevation view of an arm for the vaginal delineating and occluding device;  
         [0024]      FIG. 3   a  is a plan view of a diaphragm for the vaginal delineating and occluding device;  
         [0025]      FIG. 3   b  is a top view of a diaphragm for the vaginal delineating and occluding device;  
         [0026]      FIG. 4   a  is a plan view from the top of a second embodiment of the vaginal delineating and occluding device;  
         [0027]      FIG. 4   b  is a side elevation view of the second embodiment of the vaginal delineating and occluding device;  
         [0028]      FIG. 4   c  is a plan view from the bottom of the second embodiment of the vaginal delineating and occluding device;  
         [0029]      FIG. 4   d  is a first side elevation view of an arm for the second embodiment vaginal delineating and occluding device;  
         [0030]      FIG. 4   e  is a second side elevation view of an arm for the second embodiment vaginal delineating and occluding device;  
         [0031]      FIG. 5   a  is a side elevation view of a third embodiment of the vaginal delineating and occluding device minus a solid ring to clearly show angles;  
         [0032]      FIG. 5   b  is a cutaway side elevation view of a third embodiment of the vaginal delineating and occluding device;  
         [0033]      FIG. 5   c  is a side elevation view of a third embodiment of the vaginal delineating and occluding device;  
         [0034]      FIG. 5   d  is a plan view from the top of a third embodiment of the vaginal delineating and occluding device; and  
         [0035]      FIG. 6  is a cutaway view of a female pelvis, the vaginal delineating and occluding device being mounted on a uterine mobilizer and inserted into the vagina.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0036]     A first, preferred embodiment of a vaginal delineating and occluding device  100  is shown in  FIG. 1  along with a uterine mobilizer  110  as disclosed in U.S. Pat. No. 5,562,679 which is hereby incorporated by reference. The vaginal delineating and occluding device  100  is attached to the head  120  of the uterine mobilizer  110 . The device shown in detail in  FIGS. 2   a - e  is a first embodiment of the vaginal delineating and occluding device  100  of the present invention. A base  205  has an extension  250  for insertion into the head  120  of the uterine mobilizer  110  and is locked therein. The proximal end  215  of the base  205  is for attaching obturators of various lengths. A solid metal ring  200  is attached to four legs  210 ,  230 . The distal ends of a first pair of solid legs  210  are firmly affixed to the base  205 . The proximal ends of the legs  210  are pivotally attached to the ring  200  via pins  220  about which the ring  200  may pivot. The ring  200  is permitted to pivot about 20° in both directions from a plane perpendicular to a longitudinal axis of the base  205 . This pivoting permits the accommodation of various angles of the vaginal fornix  620  (see  FIG. 6 ).  
         [0037]     The first pair of legs  210  are preferably of a single piece, solid throughout.  
         [0038]     The second pair of legs  230  are telescopic and comprise a plurality of parts as detailed in  FIG. 2   e . A distal end of a secure arm  255  is firmly affixed to the base  205 . The proximal end of the secure arm  255  engages a pin  280  to which an inner telescoping arm  265  is pivotally attached. The inner telescoping arm  265  slides into the distal end of an outer telescoping arm  260 . The outer telescoping arm  260  is pivotally attached to the ring  200  at its proximal end by a pin  270 . The outer telescoping arm  260  is a hollow tube to receive the proximal end of the inner telescoping arm  265 .  
         [0039]     A diaphragm  225  of elastic material such as plastic, nylon, silicon, etc. is shown in  FIGS. 3   a  and  3   b . Its use is to obstruct the vagina for the prevention of carbon dioxide leakage from the peritoneal cavity when the vagina is opened laparoscopically. The diaphragm  225  has a hole  300  in its center through which an enlarged portion  275  of the base  205  of the vaginal delineating and occluding device  100  passes and helps secure the diaphragm  225 . When the distal end of the base  205  is inserted in the uterine mobilizer  110 , the diaphragm  225  is held securely between the base  205  and the mobilizer  110 . Various sizes of diaphragms  225  may be supplied to fit a variety of patients. About the circumference of the diaphragm  225  is an enlarged portion  310 . A center annulus  320  is thicker than a center membrane  330 .  
         [0040]     A second embodiment of the vaginal delineating and occluding device  100  is shown in  FIGS. 4   a - e . In this embodiment, all the legs  410  are made as the telescoping legs  230 , described above. In addition, a spring  440  applies a force to separate the solid ring  200  away from the base  205 . The spring  440  may bear directly on the secure arm  255  and the outer telescoping arm  260  as shown in  FIG. 4   d ; or it may bear on the inner telescoping arm  265  and the solid ring  200  as shown in  FIG. 4   e . In this embodiment, the location of the solid ring  200  relative to the base  205  is adjustable to accommodate various lengths of the cervix.  
         [0041]     A third embodiment of the present invention is shown in  FIGS. 5   a - d . Here, a cup  500  is illustrated the rim of which has a slope in two opposite directions, the slope having an angle, θ, where θ is about 15°. This cup  500  is attached in the same way into the head  120  of the uterine mobilizer  110  via the extension  250 . Pivotally attached at the top if the cup  500  is a rigid ring  510 , preferably constructed of a metallic material. The rigid ring  510  is pivotally attached to pins  520  that permit the ring to tilt through the angle, θ, as far as the rim of the cup  500 , again, about 15°. The view in  FIG. 5   a  is intentionally without the ring  510  to show the angle θ. The ring  510  bears against the fornix  620 , while the cup  500  acts to occlude the vagina, replacing the diaphragm  225  of the previous embodiments.  
         [0042]     The vaginal delineating and occluding device  100  of the first embodiment is shown in use in  FIG. 6 . The vaginal delineating and occluding device  100  is inserted into a vagina  610  using the uterine mobilizer  110  until the ring  200  of the vaginal delineating and occluding device  100  rests against the vaginal fornix  620 .  
         [0043]     The above embodiments are the preferred embodiments, but this invention is not limited thereto. It is, therefore, apparent that many modifications and variations of the present invention are possible in light of the above teachings. It is, therefore, to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described.