Abstract:
A circumcision device ( 10 ) including a proximal end ( 16 ), a distal end ( 18 ), an inner recess ( 30 ) and an outer surface. The inner recess ( 30 ) opens from the proximal end ( 16 ) and is adapted to receive substantially all of a glans of a penis therein. The outer surface includes a plurality of indicators ( 26 ) spaced apart from the proximal end ( 16 ). In use, a foreskin is pulled over the outer surface until the foreskin reaches a predetermined one of the indicators ( 26 ), thereby providing a visual guide to the level of circumcision.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     This application is a National Stage of International Application No. PCT/AU2010/000966 filed Jul. 30, 2010, which claims the benefit of Australian Provisional Application No. 2009903801, filed Aug. 13, 2009, the disclosures of which are all incorporated herein by reference. 
     FIELD OF THE INVENTION 
     The present invention relates to a circumcision device and a method of circumcision. The circumcision device has been developed for use in circumcising male infants and children and will be described hereinafter with reference to this application. 
     BACKGROUND OF THE INVENTION 
     The most wide spread single use circumcision device currently in use is marketed under the trademark PLASTIBELL. The PLASTIBELL device has a domed plastic ring with a frangible handle, and is available in six sizes. To use the PLASTIBELL device, the adhesions between the glans and foreskin are divided with a probe and the foreskin is then cut longitudinally to allow it to be retracted to expose the glans. The appropriate sized PLASTIBELL device is then selected and the ring applied to the head of the penis. The ring is then covered over by the foreskin and a ligature is tied firmly around the foreskin, which crushes the skin against the ring. The excess skin protruding beyond the ring is then trimmed off. To end the circumcision procedure, the handle is broken off the ring. The ring typically falls off in three to seven days leaving a circumferential wound that heals over the following week. 
     The PLASTIBELL device has several disadvantages. Firstly, the glans is unprotected during the circumcision procedure. As the ligature which is used to secure the foreskin must be tight, any slippage can cause injury to the glans. 
     Secondly, once the PLASTIBELL device is in place and the foreskin is clamped thereto, it is extremely difficult, due to a lack of visibility, to determine where the ring begins and where the glans ends. This is due to the foreskin covering the majority of the ring. This makes it difficult for the surgeon to perform the circumcision as it leads to difficulty in locating the area in which to tie the ligature. This in turn may lead to injury such as urethrocutaneous fistulae, extensive skin loss, dysuria, or ischemic necrosis. 
     Thirdly, once the PLASTIBELL device is in place, it governs how much of the foreskin may be removed. This is because the glans is pressed up against the ring, which blocks the glans from moving through the ring any further. This can result in only a limited, often less than ideal, amount of foreskin being able to be removed. 
     OBJECT OF THE INVENTION 
     It is the object of the present invention to substantially overcome or at least ameliorate one or more of the above disadvantages. 
     SUMMARY OF THE INVENTION 
     Accordingly, in a first aspect, the present invention provides a circumcision device including: 
     a proximal end; 
     a distal end; 
     an inner recess opening from the proximal end and adapted to receive substantially all of a glans of a penis therein; and 
     an outer surface including a plurality of indicators spaced apart from the proximal end, 
     wherein, in use, a foreskin is pulled over the outer surface until the foreskin reaches a predetermined one of the indicators, thereby providing a visual guide to the level of circumcision. 
     The device preferably includes a first outwardly protruding peripheral flange about the proximal end. The device preferably also includes a second outwardly protruding peripheral flange about the distal end. The first flange is preferably larger in diameter than the second flange. 
     In a second aspect, the present invention provides a circumcision device including: 
     a proximal end; 
     a distal end; 
     an inner recess opening from the proximal end and adapted to receive substantially all of a glans of a penis therein; and 
     a first outwardly protruding peripheral flange about the proximal end. 
     The device preferably also includes a second outwardly protruding peripheral flange about the distal end. The first flange is preferably larger in diameter than the second flange. 
     The device preferably includes a generally cylindrical body, most preferably with a tapered part adjacent the distal end. The device preferably includes a handle, frangibly attached to the body, most preferably adjacent the distal end. 
     The indicators are preferably formed on the exterior of the body. 
     The recess is preferably formed within the body. The recess is preferably inwardly concave. 
     The indicators are preferably in the form of outwardly protruding peripheral ribs. The ribs are preferably longitudinally, most preferably equally, spaced apart. The device preferably includes four or five ribs. 
     In a third aspect, the present invention provides a method of circumcision including the following steps: 
     inserting substantially all of a glans of a penis into an inner recess in a proximal end of a circumcision device; 
     pulling a foreskin over an outer surface of the circumcision device, until the foreskin reaches a predetermined one of a plurality of indicators, spaced from the proximal end, corresponding to a selected level of circumcision; and 
     tying a ligature around the foreskin adjacent the predetermined one of said indicators. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Preferred embodiments of the invention will now be described, by way of examples only, with reference to the accompanying drawings in which: 
         FIG. 1  is a perspective side view of a first embodiment of circumcision device; 
         FIG. 2  is a perspective rear view of the device shown in  FIG. 1 ; 
         FIG. 3  is a further perspective side view of the device shown in  FIG. 1 ; 
         FIG. 4  is a perspective front view of the device shown in  FIG. 1 ; 
         FIGS. 5 to 10  show sequentially the use of the device shown in shown in  FIG. 1  during a circumcision procedure; 
         FIG. 11  is a perspective rear view of a second embodiment of circumcision device; 
         FIG. 12  is a perspective rear view of a third embodiment of circumcision device; 
         FIG. 13  is a perspective side view of the circumcision device shown in  FIG. 12 ; and 
         FIG. 14  is a perspective rear view of a fourth embodiment of circumcision device. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       FIGS. 1 to 4  show a first embodiment of a single use circumcision device  10 . The device  10  includes a generally cylindrical body  12  to which is frangibly attached a handle  14 . The body  12  and handle  14  are moulded as a single component from a medical grade plastics material able to withstand sterilization. 
     The body  12  is generally cylindrical in shape and includes a proximal end  16  and a distal end  18 . The proximal end  16  includes a first outwardly protruding peripheral flange  20 . A second outwardly protruding peripheral flange  22  is provided adjacent to the distal end  18 . The first flange  20  has a larger diameter than the second flange  22 . 
     The body includes a cylindrical part  24  stemming from the first flange  20  which includes  4  outwardly protruding peripheral ribs  26 . The cylindrical part  24  is connected to the second flange  22  via a tapering part  28 . 
     As best shown in  FIGS. 3 and 4  the interior of the cylindrical part  24  and tapered part  28  form an inwardly concave recess  30 . 
     The device  10  is available in 9 sizes. In the device  10  shown in  FIGS. 1 to 4 , the recess  30  has an internal diameter of about 13 mm. The external diameter of the body  24  between the ribs  26  is about 14 mm. The cylindrical part  24  of the body  12  is about 16 mm in length. The handle  14  is approximately 35 mm in length. The first flange is about 2 mm thick, the second flange  22  is about 1.5 mm thick and the ribs  26  are about 1 mm thick. The ribs  26  are spaced apart by about 1 mm. It will be understood that these dimensions can be scaled up or down for other sizes of the device  10 . 
     The use of the device  10  in a circumcision procedure shall now be described with reference to  FIGS. 5 to 10 . The device  10  is supplied in a sterilized blister pack (not shown). As shown in  FIG. 5 , the appropriate size of device  10  is selected, to suit the size of a penis  40  to be circumcised, and removed from the blister pack. 
     As shown in  FIG. 6 , the adhesions between glans  42  and foreskin  44  are divided with a probe and the foreskin  44  is then cut longitudinally to allow it to be retracted to expose the glans  42 . 
     As shown in  FIG. 7 , the device  10  is then applied to the glans  42  of the penis, with the body  12  completely covering the glans  42 . Put another way, the glans is completely received within the recess  30 . The body  12  covers the entire glans  42 , which is inserted up to the coronal sulcus. This ensures that proximal migration is not possible as the flange  20  around the proximal opening is wedged between the coronal sulcus, the foreskin  44  and the ligature  48 . (as seen in  FIGS. 8, 9 and 10 ). 
     As shown in  FIG. 8 , the foreskin  44  is then send stretched over the exterior of the body  12  using clamps  46 . 
     As shown in  FIG. 9 , a ligature  48  is tightly tied around the foreskin  44  crushing it against the exterior of the body  12 . The body  12  covers the entire glans  42 , which is inserted into the recess  30  up to the coronal sulcus  50 . This ensures that proximal migration is not possible as the flange  20  around the proximal opening is wedged between the coronal sulcus  50 , the foreskin  44  and the ligature  48  (as seen in  FIGS. 8, 9 and 10 ). The surgeon is able to determine where to apply the ligature along the exterior of the body  12  by feeling the flange  20  and also the ribs  26  through the foreskin  44 . The positioning of the ligature  48  and thus the amount of the foreskin  44  being removed in the circumcision procedure can thus be accurately determined, allowing the surgeon to select o either what is termed a ‘tight’ circumcision (i.e. a relatively large amount of foreskin removal) or a ‘loose’ circumcision (i.e. a relatively small amount of foreskin removal) or some level therebetween. Once the ligature  48  has been securely tied the excess skin protruding beyond the ligature  48  is trimmed off and the handle  14  is broken away from the body  12 . The body  12  typically falls off in 3 to 7 days leaving a circumferential wound that heals over the following week. 
     The device  10  provides several advantages. Firstly, the glans of the penis is substantially completely covered (i.e. received within the recess  30 ), thereby protecting it from damage which may be caused by an incorrectly positioned ligature or a scalpel error. 
     Secondly, the position of the first flange  20  and thus the position of the body  12 , can be easily determined by the surgeon by feeling the flange  20  through the foreskin. This reduces the likelihood of the ligature slipping over and off the proximal end of the device  10  and injuring the glans or remainder of the penis. 
     Thirdly, the second flange  22  at the distal end of the body provides an easily recognisable guide to the surgeon as to the end of the body. This advantageously reduces the possibility of the ligature being positioned (incorrectly) at a position where it may slip distally. 
     Fourthly, the ribs  26  serve as indicators as to the distance from the first flange  22  allowing the surgeon to easily and accurately determine a preferred position for the ligature and therefore the preferred amount of circumcision. 
     Fifthly, the groove created between each adjacent pair of ribs  26  improves the security of the location of the fastened ligature. 
     Sixthly, once the device  10  is in positioned on the glans, there is no tension in the foreskin attempting to pull the device  10  proximally. This is in contrast to the PLASTIBELL device, which the foreskin has to be pulled towards, creating an elastic tension attempting to pull the PLASTIBELL device proximally. The device  10  needs no pulling of the foreskin, thus removing the possibility of proximal migration occurring and avoiding injury. 
     Finally, the device  10  is used in a generally similar manner to the PLASTIBELL device, and therefore requires only minimal training before use. 
     A second embodiment of circumcision device  10 ′ in shown in  FIG. 11 . The device  10 ′ is similar in construction and use to the device  10  previously described, except that it also includes two strips  60  across the opening within the second flange  22 . The strips  60  ensure that proximal migration of the penis through the device  10 ′ does not occur, by blocking the glans from sliding through the opening. 
     A third embodiment of circumcision device  10 ″ in shown in  FIGS. 12 and 13 . The device  10 ″ is similar in construction and use to the device  10  previously described, except that the tapering part  28  includes a chordal region  70 . The chordal region  70  provides locations, indicated by arrows  72 , in which pincers used to hold the foreskin can easily attach to, in comparison to having a tapering part with a circular cross section. This makes it easier for the surgeon to position the pincers during the circumcision procedure. 
     A fourth embodiment of circumcision device  10 ′″ in shown in  FIG. 14 . The device  10 ″′ is similar in construction and use to the device  10  previously described, except that the tapering part  28  is omitted, the body  12  is cylindrical and it has five of the ribs  26 . This tapering part  28  is omitted to eliminate the (minute) risk of this part causing any chance of ischemia to the glans  42 . The region where the handle  14  meets the cylindrical part is also designed to ensure the stress is concentrated where the handle meets the cylindrical part when the surgeon applied a force to break the handle off. This ensures a clean break, without sharp edges, when the handle  14  is to be broken off the body  12  post-circumcision. 
     Although the invention has been described with reference to preferred embodiments, it will be appreciated by those persons skilled in the art that the invention may be embodied in many other forms. For example, the device can include a third peripheral flange between the first and second flanges, which serves to act as a guide for a medium amount of skin removal. The length of the tapered part can also be increased to provide a narrower distal opening within the second flange. This will also prevent the glans from passing through the distal opening, whilst allowing urination. Alternatively, the tapered part can be deleted such that the cylindrical part extends between the first and second flanges. This ensures that, even if the glans does slide through the cylindrical part, there will be no harm to the glans.