Abstract:
A circumcision clamp system and related methods of use. The clamp system includes an inner ring that is placed under the foreskin proximate to the corona of the glans penis, and an outer ring that clamps the foreskin against the inner ring. In an embodiment suitable for necrotic circumcisions, the inner and outer rings include one or more break-off sections that enable a clinician to adjust the diameter of the clamp accordingly. The inner ring includes a key and lock arrangement that ensures the inner ring maintains a circular shape by denying all degrees of freedom to the joined sections thereof. The outer ring includes a plurality of clamping members extending radially inward from an inner surface thereof. In some embodiments, the outer ring includes castellations that work in cooperation with longitudinal grooves in the inner ring to aid in suture placement.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/490,679, filed on May 27, 2011, the entire contents of which are incorporated herein by reference. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure generally relates to the field of circumcision, and more particularly, the present disclosure relates to apparatus and methods for reducing hemorrhaging, improving suture placement, and improving surgical outcomes during male circumcision procedures. Fixed size and adjustable size apparatus are presented with related methods of use. 
     2. Background of Related Art 
     The foreskin, or prepuce, is the retractable sheath of skin that covers the head, or glans, of a penis. The outside of the foreskin is a continuation of the skin on the shaft of the penis, while the inner foreskin includes mucous membrane, similar to the inside of the eyelid. Male circumcision is a procedure whereby the foreskin is removed, typically for health, religious, or cultural reasons. 
     Conventional circumcision may be performed by applying a local anesthetic to the penis, applying an appropriately-sized clamp to the foreskin, removing the foreskin using a scalpel or scissors, and suturing the wound. Alternatively, the foreskin may be clamped in a necrosing device such as a Shang Ring, whereby the foreskin is drawn over a first ring, a second ring is positioned on the foreskin outside the first ring, and the foreskin is crushed between the two rings, which in about a week results in necrosis of the foreskin. In each case, the penis must first be measured, or sized, to determine which diameter clamp to use during the procedure. 
     Conventional circumcision techniques may have drawbacks. In one respect, conventional devices require the practitioner to have considerable skill in order to avoid complications such as excessive hemorrhaging, infection, and/or permanent insult to the penis. In another respect, a variety of clamp sizes need to be inventoried to accommodate differently-sized penises. This may create logistical challenges, particularly in rural or remote regions where access to supply chains are limited. In another respect, necrotic techniques and clamps typically require a follow-up visit to a medical facility so that the device may be removed. The need for follow-up visits can be problematic in rural or remote areas, where lack of transportation, harsh terrain, or long distances may hinder or preclude a patient from returning to the doctor. 
     SUMMARY 
     The present disclosure is directed to a circumcision system for surgically removing excess foreskin from a penis. In some embodiments, a circumcision clamp system in accordance with the present disclosure includes a ring clamp having an open position and a closed position, The ring clamp includes a first semicircular portion having a first clasp end, and a first hinge end. The ring clamp further includes a second semicircular portion having a second clasp end, and a second hinge end pivotably joined to the first hinge end of the first semicircular portion. The ring clamp includes one or more castellations radially disposed about a periphery of the ring clamp and projecting longitudinally therefrom, defining one or more slots therebetween. The disclosed circumcision clamp system includes a generally cylindrical collar having a distal end and a proximal end and having one or more longitudinal grooves defined on an outer surface thereof. The ring clamp and a distal end of the generally cylindrical collar are adapted to clamp tissue (e.g., male foreskin) therebetween. The circumcision clamp system in accordance with claim  1 , wherein the first clasp end includes an outer interlocking member having an outer pawl and the second clasp end includes an inner interlocking member having an inner pawl. A diameter of a proximal end of the collar may be greater than a diameter of a distal end of the collar. The outer surface of the distal end the collar may include a soft lining. The ratio of the number of longitudinal grooves of the collar to the number of castellations of the ring clamp may be about 5:1. 
     In another embodiment in accordance with the present disclosure, a circumcision clamp system includes an elongate inner support member having a first end and a second end. The first end and the second end are configured to operably engage to form an inner ring. A portion of the inner support member is selectively removable to change the diameter of the inner ring. In some embodiments, a portion of second end of the inner support member may be broken away to shorten the inner support member, which, in turn, decreases the diameter of the inner ring formed therefrom. The inner support member may include one or more scored portions to facilitate breaking off a section thereof. The disclosed circumcision clamp system includes an outer support member having a first end and a second end. The first end and the second end of the outer support member are configured to operably engage to form an outer ring. A portion of the outer support member is selectively removable to change the diameter of the outer ring. In some embodiments, a portion of second end of the outer support member may be broken away to shorten the outer support member, which, in turn, decreases the diameter of the outer ring formed therefrom. The outer support member may include one or more scored portions to facilitate breaking off a section thereof. The outer ring includes a plurality of clamping elements extending radially inward from an inner surface thereof. The inner ring and plurality of clamping elements are adapted to clamp tissue, e.g., male foreskin, therebetween. The outer support member may include a plurality of clamping segments. The clamping segments may be joined by a living hinge. A clamping segment may include a clamping element. 
     A disclosed circumcision clamp system may include a clasp assembly configured to join the first end and the second end of the outer support member. The clasp assembly may include an outer interlocking member having an outer pawl, and an inner interlocking member having an inner pawl. The outer interlocking member may be associated with a first end of an inner support member or an outer support member. The inner interlocking member may be associated with a second end of an inner support member or an outer support member. 
     A circumcision clamp system in accordance with the present disclosure may include an inner support that further includes a generally semicircular key having a coupling end and a base and extending from the first end of the inner support. One or more undercuts may be defined at the base of the key. The undercuts are configured to operably engage a corresponding lock included in a second end of the inner support. The inner support may include one or more walls extending from an outer surface of the inner support partially enclosing the one or more undercuts. 
     A circumcision clamp system in accordance with the present disclosure may include an inner support that further includes a generally semicircular lock defined in a second end thereof that includes one or more lobes configured to operably engage a corresponding undercut defined in the first end of the inner support. 
     Also disclosed herein is a method of performing male circumcision. In some embodiments, the disclosed method includes the steps of determining penis size within a set of standard penis sizes. A circumcision clamp is selected in accordance with the determined penis size. A generally cylindrical collar having a distal end and a proximal end and having one or more longitudinal grooves defined in an outer surface thereof is positioned around the corona of the glans penis. A small coaxial incision is made in the foreskin around the corona of the glans penis. The foreskin is rolled proximally toward a distal end of the cylindrical collar. A ring clamp in an open position is positioned around the foreskin. The ring clamp is closed around the foreskin to clamp the foreskin between the cylindrical collar and the ring clamp. The excess foreskin is removed, e.g., using scalpel or scissors. The open foreskin tissue is sutured, and the ring clamp and the cylindrical collar are removed from the penis. The provided ring clamp may include a first semicircular portion having a first clasp end and a first hinge end, and a second portion having a second clasp end and a second hinge end pivotably joined to the first hinge end of the first semicircular portion. The provided ring clamp may include one or more castellations radially disposed about a periphery of the ring clamp and projecting proximally therefrom and defining one or more slots therebetween. The disclosed method may additionally include passing a suturing needle through a slot, passing the suturing needle through open foreskin tissue, and guiding the suturing needle in cooperation with a longitudinal groove defined in an outer surface of the cylindrical collar. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein: 
         FIG. 1  is a perspective view of an embodiment of a circumcision clamp system in accordance with the present disclosure showing a clamp in an open position; 
         FIG. 2  is a perspective view of the circumcision clamp system shown in  FIG. 1  showing the clamp in a closed position; 
         FIG. 3  is a perspective view of the circumcision clamp system shown in  FIG. 1  showing a relationship between a ring and a suturing needle; 
         FIG. 4  is a detail perspective view of the circumcision clamp system shown in  FIG. 1  showing a relationship between a ring and a suturing needle; 
         FIG. 5  is a perspective view of an alternative embodiment of the presently disclosed circumcision clamp system including an adjustable circumcision ring and an adjustable circumcision clamp in accordance with the present disclosure; 
         FIG. 6  is a perspective view of the adjustable circumcision ring shown in  FIG. 5 ; 
         FIG. 6A  is a detail perspective view of a portion of the adjustable circumcision ring shown in  FIG. 5 ; and 
         FIG. 7  is a perspective view of the adjustable circumcision clamp shown in  FIG. 5 . 
     
    
    
     DETAILED DESCRIPTION 
     Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions and repetitive matter are not described in detail to avoid obscuring the present disclosure in unnecessary or redundant detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. In this description, as well as in the drawings, like-referenced numbers represent elements which may perform the same, similar, or equivalent functions. 
     In the drawings and in the descriptions that follow, terms referencing orientation, e.g., “top”, “bottom”, “up”, “down”, “left”, “right”, and the like, are used for illustrative purposes with reference to the figures and features shown therein. Embodiments in accordance with the present disclosure may be practiced in any orientation without limitation. 
     Referring to  FIG. 1 , a circumcision clamp system  100  is presented. The circumcision clamp system  100  includes a hinged clamp  110  and a generally cylindrical collar  120 . Hinged clamp  110  includes a first semicircular portion  112  having a clasp end  131  and a hinged end  132 , and a second semicircular portion  114  having a clasp end  133  and a hinged end  134 . First semicircular portion  112  and second semicircular portion  114  are joined at the respective hinged ends  132 ,  134  thereof by a hinge  111  that enables the semicircular portions  112 ,  114  of clamp  110  to move between an open position as exemplified in  FIG. 1 , and a closed position as shown in  FIG. 2 . 
     The respective clasp ends  131  and  133  of first semicircular portion  112  and second semicircular portion  114 , respectively, include a cooperatively interlocking clasp  115  ( FIG. 2 ) that is configured to retain first semicircular portion  112  and second semicircular portion  114  in the closed position during use. At a clasp end  131  thereof, semicircular portion  112  includes an outer interlocking member  116  having an outer pawl  136  ( FIG. 2 ). Outer pawl  136  is configured to operably engage a mating inner pawl  135  of inner interlocking member  117  that is disposed at a clasp end  133  of semicircular portion  114 . In some embodiments, semicircular portion  112  and semicircular portion  114  are formed from material that enables outer interlocking member  116  and inner interlocking member  117  to radially deflect when first semicircular portion  112  and second semicircular portion  114  are moved between a closed position and an open position, e.g., enabling outer interlocking member  116  to ride over inner interlocking member  117  to facilitate the cooperative engagement and/or disengagement thereof. An inner clamping portion  113  projects radially inward from first semicircular portion  112  and second semicircular portion  114 . When first semicircular portion  112  and second semicircular portion  114  are in the closed position, inner clamping portion  113  cooperates with one end  122  of collar  120  to grasp foreskin tissue therebetween during a circumcision procedure. Advantageously, the diameter of clamping portion  113  is slightly larger than end  122  of collar  120 , such that during a circumcision procedure, tissue may be clamped sufficiently between inner clamping portion  113  and collar  120  to minimize bleeding and to promote hemostasis, without crushing the tissue. In some embodiments, the clearance between clamping portion  113  and end  122  of collar  120  is in a range of about 0.025″ to 0.050″. 
     As best seen in  FIGS. 3 and 4 , clamp  110  includes a plurality of radially-arranged castellations  118  projecting laterally and proximally from a proximal edge of clamp  110 . A plurality of slots  119  are defined between the castellations  118 . During use, one or more of the slots  119  may be used as a suture guide, which may assist a surgeon to evenly suture a wound, using a sufficient number of sutures. 
     Circumcision clamp system  100  includes an annular collar  120  having an end  122  having a first diameter and an end  124  having a second diameter that is greater than the first diameter of end  122 . In some embodiments, the diameter of collar  120  increases from the first diameter to the second diameter in a flared (e.g., exponential) manner, as depicted in  FIGS. 1-4 . In some embodiments, the diameter of collar  120  may increase from the first diameter to the second diameter in a linear (e.g., straight) manner. An outer surface  126  of collar  120  includes a plurality of longitudinal grooves  125  defined therein. Each longitudinal groove  125  is configured to accommodate the width of a suturing needle used during circumcision procedures. For example, and without limitation, longitudinal groove  125  is dimensioned to accommodate a Surgipro CV-24½ circle, 20 mm needle. During use, a longitudinal groove may further assist a surgeon to neatly and evenly suture an incision by enabling the suturing needle to capture both layers of the skin, and/or keeping the suturing needle oriented longitudinally as the sutures are stitched into tissue. 
     Collar  120  may include a lining  123  formed about end  122  thereof. Lining  123  may be formed from an elastomeric or resilient material, such as, silicone, rubber, or the like. Alternatively, the use of other known resilient materials is envisioned. In some embodiments, lining  123  may be joined to collar  120  by overmolding. 
     During use of circumcision clamp  100 , a surgeon may administer antiseptic and local anesthesia to the penis. The penis is then sized to determine clamp system size. It is envisioned that circumcision clamp system  100  be provided in one or more sizes, e.g., diameters, to accommodate use with penises of differing girths. The desired clamp size is selected, and end  122  of collar  120  is positioned around the corolla of the glans penis. Next, a small coaxial incision is made in the foreskin. The foreskin is then rolled over itself, generally proximally and over end  122  of collar  120 . Hand instruments may be used to manipulate the foreskin into position over collar  120 . Hinged clamp  110  in its open position is then positioned around the foreskin and end  122  of collar  120 , and the clamp  110  is closed, e.g., clasp  115  is engaged, thereby clamping the foreskin between clamping portion  113  and distal end  122  of collar  120 . The excess foreskin is then removed using any suitable manner of resection, including without limitation using scissors or a scalpel. The wound is then stitched by passing a suturing needle through a slot  119  and through the open foreskin tissue. Advantageously, the collar  120  protects the corona and glans penis from accidental puncture by the needle, while slots  119  assist in placing the stitches uniformly about the penis. Lateral grooves  125  in collar  120  help to guide the needle under the edge of the skin, to capture both edges of the foreskin during suturing, and may further assist the surgeon in placing the stitches uniformly. After closing the wound (e.g., all stitches have been placed), the clasp  115  of hinged clamp  110  is released, and clamp  110  and collar  120  are removed from the penis. The wound is then dressed in accordance with standard medical practice. 
     Referring now to  FIGS. 5-8 , another embodiment of a circumcision clamp system  200  in accordance with the present disclosure is shown. The disclosed universal adjustable clamp system  200  may be used for necrotic circumcision procedures and includes an adjustable outer ring  210  ( FIG. 7 ) and an adjustable inner ring  250  ( FIG. 6 ). Inner ring  250  and outer ring  210  include one or more removable segments  256 ,  218 , respectively, that may be broken off to enable clamp system  200  to be configured for use with penises of different size. 
     Inner ring  250  includes body portion  250   a  and one ore more removable segments  256 . Ring  250  defines an inner surface  253  which, during use, is positioned generally towards the glans penis and an outer surface  252  which is positioned generally toward the inner foreskin membrane. Body portion  250   a  includes a key end  257  and a lock end  262  which may be selectively coupled to form the ring, or uncoupled to enable sizing as described below. Each removable segment  256  also includes a lock end  262  which may be selectively coupled to key end  257  to form ring  250 . 
     With particular reference to  FIG. 6A , key end  257  includes a key  258  extending therefrom having a generally semicircular shape. One or more undercuts  260  are defined in the base of key  258  that correspond in shape to lock ends  262  of body portion  250   a  and removable segments  256 . Each lock end  262  has a generally semicircular shape corresponding to key  258  and includes one or more lobes  261  that are configured to mate with corresponding undercuts  260  of key end  257 , enabling key  258  to fixedly “snap” into lock end  262  to couple the mating ends to form inner ring  250 . A portion of the outer surface  252  of inner ring  250  extends beyond undercuts  260  to form two pairs of walls  259 , one on each side of key  258 . When a lock end  262  is secured to key  258 , walls  259  confine lobes  261  within undercuts  261  thereby imparting rigidity to the structure of inner ring  250 . In some embodiments, walls  259  and undercuts  260  cooperate to deny some or all degrees of freedom to the joined ends of inner ring  250 . Inner ring  250  may be formed from any suitable biocompatible material that promotes even curvature and is capable of assuming a circular shape when inner ring  250  is in a coupled configuration. In some embodiments, inner ring  250  may be formed from polymeric material, including without limitation, polypropylene, polyethylene, polyvinyl chloride, nylon, ABS, and/or Radel® polyphenylsulfone (PPSU) manufactured by Solvay Plastics of Brussels, Belgium. 
     Removable segments  256  may be selectively removed, or “snapped off” body portion  250   a  along one or more scored break lines  255  to facilitate sizing of inner ring  250 . For example, one removable segment may be removed from body portion  250   a  to decrease the diameter of inner ring  250  to a first extent, or two removable segments  256  may be removed from body portion  250   a  to reduce the diameter of inner ring  250  to a second extent. Inner ring  250  may include one or more identification numbers  254  that correspond to standard penis sizes. During use, a clinician may size a patient&#39;s penis using a standardized gauge. If necessary, the clinician may then uncouple the inner ring  250 , break off the unwanted removable segments  256 , and re-couple the inner ring  250 . The one or more break lines  255  are configured to enable facile separation of the removable segments  256  and to leave a clean, newly-exposed lock end  262  that, in turn, may be coupled to key  258  as previously described. Although two removable segments  256  are shown in the figures, inner ring  250  may include one or more removable segments  256 , e.g., four. 
     Adjustable outer ring  210  includes a plurality of clamping segments  220  having a first end  226  and a second end  227 . Outer ring  210  may be arranged in a generally circular configuration, e.g., a closed position, wherein a clasp assembly  225  joins first end  226  and a second end  227  of outer ring  210 . Alternatively, outer ring  210  may be configured in an open position wherein first end  226  and a second end  227  are not joined. Clasp  225  includes an outer interlocking member  227  having an outer pawl  217  and an inner interlocking member  228  having an inner pawl  216 . Outer pawl  217  and inner pawl  216  are designed to selectively and releasably engage one another to join first end  226  and second end  227  of outer ring  210 . Each of the plurality of clamping segments  220  are joined to at least one adjacent clamping segment  220  by a living hinge  214  that enables outer ring  210  to flex between an open position and a closed position. 
     Adjustable outer ring  210  includes one or more removable segments  222  that may be selectively removed, or “snapped off”, along one or more scored break lines  221  to facilitate the sizing of outer ring  250 . Each of the one or more removable segments  222  includes an inner interlocking member  228  an inner pawl  216  associated therewith to facilitate clamping when another removable segment  222  has been removed. The one or more removable segments  222  include one or more identification numbers  218  that correspond to standard penis sizes. During use, similarly-numbered sections of inner ring  250  and outer ring  210  may be broken off to enable mutually cooperative sizing of inner ring  250  and outer ring  210  for use. Advantageously, this disclosed arrangement provides a controlled gap  263  between an outer surface  252  of inner ring  250  and the one or more clamping faces  219  of outer ring  210 , as described in detail below. The controlled gap  263  is configured to clamp foreskin tissue with sufficient force to ensure hemostasis with sufficient pressure to promote necrosis but without excessive pressure that will cause the tissue to break. In this manner, improved circumcision outcomes may be attained while minimizing complications or undue discomfort. 
     A clamping element  223  extends radially inward from an inner surface  212  of one or more clamping segments  220  and/or removable segments  222 . In the illustrated embodiment, clamping element  223  has a generally open trapezoidal shape and includes a clamping face  219  that is joined to an inner surface  212  of clamping segment  220  by a pair of posts  213  defining generally trapezoidal opening  224 . Alternatively, clamping elements  223  may be secured or formed on an inner surface of clamping segments  223  in a variety of different manners using a variety of different techniques. Posts  213  may be resilient, e.g., may flex slightly to promote even distribution of a clamping force. In some embodiments, clamping element  223  may have a closed trapezoidal shape (e.g., having no opening  224 ), or any other suitable shape. The one or more clamping elements  223  are arranged in a staggered configuration to facilitate overlapping of the adjacent surfaces of neighboring clamping elements  223  when the clamp  200  is in use. This overlapping arrangement ensures an effectively continuous clamping surface is provided by the plurality of clamping faces  219  when the outer ring  210  is positioned around the foreskin. 
     Outer ring  210  may be formed from any suitable biocompatible material that promotes operation of living hinges  214  and is capable of generating sufficient clamping force for clamping element  223 . In some embodiments, outer ring  210  may be formed from polymeric material, including without limitation, polypropylene, and polyethylene. 
     During use, a surgeon may administer antiseptic and local anesthesia to the penis. The penis is then sized to determine which, if any, inner ring  250  removable segments  256  and outer ring  210  removable segments  222  need to be removed. 
     If sizing indicates that one or more segments need to be removed, inner ring  250  and outer ring  210  are re-sized by removing one or more segments  256  and  222  from the inner and outer rings  250  and  210 , respectively. To remove a segment  256  from inner ring  250 , key end  257  and lock end  262  of inner ring  250  are uncoupled, the desired removable segments  256  are broken off, and the key end  257  and newly-exposed lock end  262  are coupled to re-form inner ring  250 . 
     To remove a segment  222  from outer ring  210 , clasp assembly  225  of outer ring  210  is opened, freeing first end  226  and second end  227 , and one or more removable segments  222  of outer ring  210  are broken off as required. 
     Inner ring  250  is positioned around the glans penis underneath the foreskin. The foreskin may optionally be retracted distally to expose the glans penis, facilitating placement of inner ring  250  therearound, and the foreskin may be slid proximally, over inner ring  250 . 
     The outer ring  210 , in an open configuration, is positioned around the foreskin concentric to inner ring  250 . The first end  226  and second end  227  of outer ring  210  are brought together and clasp  225  is engaged, thereby causing the one ore more clamping faces  219  to clamp foreskin tissue against outer surface  252  of inner ring  250  and, in turn, to cause hemostasis of the foreskin proximal of the clamp (e.g., cut off the foreskin blood supply) and, ultimately, necrosis of the foreskin proximal of the clamp. Antiseptic and/or dressing may be applied to the clamped tissue and/or surrounding tissue. The clamping system  200  is left in place on the penis for a predetermined period of time. In some embodiments, clamping system  200  is left in place for about a week. Prior to the expiration of the predetermined time period, the necrotic foreskin may become detached without further intervention. After the period of time has elapsed, the necrotic foreskin (if still attached) is removed. Clasp  225  of outer ring  210  is disengaged, allowing outer ring  210  to be opened and removed form the operative site. Inner ring  250  is removed form the penis. In some embodiments, clamping system  200  may be disposable, therefore inner ring  250  and outer ring  210  may be discarded. 
     It is to be understood that various modifications may be made to the embodiments disclosed herein. Further variations of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems, devices, and applications without departing from the spirit and scope of the present disclosure. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art, which are also intended to be encompassed by the following claims.