Abstract:
A circumcision clamp and surgical kit according to the present invention includes a rod, a base, and an actuating structure. The rod is elongated and includes a bell-shaped member as well as an engagement structure. The base of the device includes two arms hinged at their distal ends, and capable of reversible engagement at their proximal ends. When closed, the arms form at least two rimmed apertures, positioned in close proximity are arrayed recesses capable of engaging the actuating structure. The actuating structure includes two members hinged such that when their proximal ends are brought together, their distal ends are opposed. The device of the present invention offers enhanced safety, simplicity, ease of use, and cost effectiveness. The device according to this invention is also part of a pre-sterilized circumcision kit for use during the circumcision procedure.

Description:
TECHNICAL FIELD 
       [0001]    The present invention relates generally to surgical clamping devices, and more specifically to a circumcision surgical clamp useful for performing circumcision operations and related surgical kits. 
       BACKGROUND OF THE INVENTION 
       [0002]    The foreskin or prepuce is a retractable double-layered fold of skin and mucous membrane that covers the glans penis and protects the urinary meatus when the penis is not erect. Often, the foreskin of the penis is removed through a procedure called circumcision. 
         [0003]    Because of the widespread use and practice of circumcision, a variety of instruments and techniques have been employed to perform the operation over the years. These instruments and techniques achieve the goal of removing excess foreskin from the penis with reduced trauma, pain, blood loss, and discomfort. It is known in the art relating to circumcision operations to provide a device to securely hold the prepuce prior to, during, and after surgical removal thereof. Certain of these devices are members of a group of circumcision devices referred to as the “bloodless” type. They clamp and squeeze the prepuce to prevent blood flow to the tissue that is to be removed. Because blood flow to the prepuce is stopped, little to no bleeding occurs at the wound site formed by cutting the prepuce. However, these devices can be difficult to use. Many of these clamps require threading both layers of the foreskin through a fixed aperture or port. This technique is difficult to perform, especially for newly admitted physicians. Often only one of the folds is properly threaded through the port, which results in an uneven circumcision. 
         [0004]    One such “bloodless” circumcision clamp is disclosed in U.S. Pat. Ser. No. 3,392,728, which includes a base having a single port at the proximal end and a stud bolt positioned at the distal end, a rod-like member having a cross pin at an upper end and a bell shaped member at the lower end, and an arm member pivotally mounted to the base and adapted for engagement with the cross pin at the proximal end and slidably mounted to the stud bolt at the distal end. The majority of the rod-like member is able to pass through the single port, but the lip of the bell is formed large enough to prevent passage through the single port. As a consequence, when the smaller end of the bell member is inserted into the port and the member is drawn through as far as it will go, the lip of the bell presses tightly around the circumference of the port. The arm member is pivotally positioned on the base such that lowering the distal end raises the proximal end. The arm member is raised and lowered by tightening or loosening a nut along the stud bolt. Operation of the device includes determining which device to utilize by evaluating the size of the single port offered by each base, drawing the prepuce over the lip of the of the bell-shaped member, feeding the rod through the single port while keeping the prepuce along the outer portion of the bell, engaging the cross pin, and tightening the nut until the prepuce is sufficiently pinched against the rimmed single port. 
         [0005]    Current devices are deficient in several respects; first, the base member includes only a single port, which does not accommodate a wide variety of patients. Therefore the practitioner is required to purchase multiple devices for the range of potential patients. Second, it is often difficult for the practitioner to perform and painful for the subject to undergo the fitting of the prepuce through the single fixed port in the base member. Third, frequently only one of the two folds of the prepuce is correctly inserted through the port resulting in an uneven circumcision. Fourth, it can be awkward for a practitioner to effectively raise the bell member when clamping the prepuce, resulting in uneven clamping due to misalignment. Therefore there remains a need to develop improved devices for performing circumcisions. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention addresses the deficiencies inherent to current devices by providing an easier-to-use, more versatile clamp that will reduce the likelihood of uneven circumcisions. More specifically the present invention provides a base that can be closed around the foreskin for effective and precise clamping of the foreskin between the bell-shaped member and rimmed aperture. This configuration permits both folds of the prepuce to be easily clamped. Further, the lower manufacturing cost (when compared to current devices) of the present invention make it ideal for one-time use, especially as a component of a pre-sterilized kit. Alternatively, the simplicity of the design lends itself to re-use following sterilization. 
         [0007]    In one aspect of the present invention a circumcision clamp is provided including a rod having a bell-shaped member at one end and a engagement structure at the opposing end, a base having two arms hinged at one end and forming at least two rimmed apertures when in the closed position, and an actuating structure including two elongated members including a handle at one end and at the opposing end one member adapted for engagement with the engagement structure for raising the rod and the other member adapted for placement in a recess or throughbore of the base for stabilizing the device. The bell-shaped member receives the prepuce and the base is capable of closing around the received prepuce for ease of use. The engagement structure engages the actuating structure such that the rod may be lifted when the handle of the actuating structure is squeezed. The actuating structure may be locked in the closed or squeezed position. 
         [0008]    The base of the device is bifurcated, with the two resulting arms hinged at one end and capable of reversible engagement to one another at the opposite end. When engaged the two arms are substantially parallel. The reversible-engagement capability of the arms provides a distinct advantage over current technology, as it allows the operator to manipulate the base around the patient, instead of, as is the current practice, drawing the patient through a single port of the base. The diameters of the rimmed apertures are different from one another, though the diameters of the rimmed apertures are in all cases smaller than the largest portion of the bell-shaped member or outer lip. This multiplicity of rimmed apertures enables the device to accommodate patients of various sizes, eliminating the need to provide several different bases, a requirement of previous devices. Positioned in close proximity of each rimmed aperture is a recess or throughbore capable of receiving the distal end of one of the elongated members that form the actuating structure. 
         [0009]    The actuating structure includes two members hinged near their midpoints or mid region. Each elongated member has a distal and proximal end, with the proximal ends forming a handle. The two members are constructed such that when the proximal ends are maximally proximate and substantially parallel, the distal ends are maximally opposed. One of the distal ends is formed for placement in the recess or throughbore of the base, and the other distal end is formed to engage the rod&#39;s engagement structure. The actuating structure is actuated by squeezing the handle. In some embodiments the actuating structure includes a locking means to lock the actuating structure in the closed or squeezed position. 
         [0010]    In another aspect of the present invention a circumcision kit is provided including a circumcision clamp and a medical instrument such as a scalpel. The kit may also include additional surgical instruments such as a hemostat and the like. The kit may be provided as a one time use device or a reusable kit. 
         [0011]    In another aspect of the present invention a method of performing a circumcision is provided including providing the circumcision clamp of the present invention, placing the head of a patient&#39;s penis in the bell-shaped member, pulling the foreskin over the outer portion of the bell-shaped member, closing the base around the bell-shaped member covered with the foreskin, inserting one of the distal ends of the actuating structure in the recess of the base and engaging the rod&#39;s engagement structure with the opposing distal end, squeezing the handle the actuating structure to raise the bell-shaped member and foreskin against the rimmed aperture, and cutting the foreskin above the base. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  is a side plan view of the circumcision surgical clamp  10  of the present invention showing the ability of the rod  12  and more specifically the bell-shaped member  14  to be raised and lowered by raising and lowering the engagement structure  16  using the actuating structure  18 .  FIG. 1A  is a lowered configuration showing the the bell-shaped member  14  substantially below the base  20 . In  FIG. 1B , the surgical clamp  10  is shown in a raised configuration. The proximal ends  22   a,b  of the actuating structure  18  are maximally proximate when the distal ends  24   a,b  are maximally opposed. In the raised configuration the bell-shaped member  14  is no longer substantially beneath the base  20 . 
           [0013]      FIG. 2  depicts various views of the preferred rod  12  of the present invention.  FIG. 2A  is a front plan view of the rod  12  depicted in  FIG. 1  showing the bell-shaped portion  14  at one end and the engagement structure  16  at the opposing end,  FIG. 2B  is a side elevational view of the rod depicted in  FIG. 1 ,  FIG. 2C  is back plan view of the rod depicted in  FIG. 1  turned on its side and  FIG. 2D  is a bottom plan view of the rod depicted in  FIG. 1  showing the inner region  15  of the bell-shaped member  14 , which is fabricated to receive the head of a penis. 
           [0014]      FIG. 3A  is a top plan view of the base  20  shown in  FIG. 1  in the closed position,  FIG. 3B  is a top plan view of the base  20  in the open position,  FIG. 3C  is a bottom plan view of the base  20  shown in  FIG. 3A  and  FIG. 3D  is an elevated side view of the base shown in  FIG. 3A . Three rimmed apertures  26   a,    26   b  and  26   c  are provided having different diameters from one another. The diameter of rimmed aperture  1   26   a  shown smaller than rimmed aperture  2   26   b,  which is shown smaller than rimmed aperture  3   26   c.  Equal sized recesses  28   a,b,c  in an arced configuration are also depicted. The base  20  includes two arms  19   a  and  19   b  hinged  30  at one end and able to reversibly engage one another  32  at the opposing end. As can be viewed in  FIG. 3C , the rimmed apertures  26  are tapered outward towards the bottom of the base  20 . 
           [0015]      FIG. 4  depicts the preferred configuration of the actuating structure  18  and parts thereof.  FIG. 3A  is a top plan view of the distal end  24   a  of the upper member  26   a,    FIG. 3B  is a top plan view of the distal end  24   b  of the lower member  34   b.    FIG. 4C  is a side elevational view of the actuating structure  18  depicted in  FIG. 1 . The actuating structure is shown in an open position in  FIG. 4C  and a closed or squeezed position in  FIG. 4D . The actuating structure  18  includes two elongated members  34   a  and  34   b  hinged  36  at about their midpoint The proximal end  22  includes a handle  36  and a locking means  38  for locking the upper  34   a  and lower  34   b  members in a closed configuration. The distal end  24   a  of the upper elongated member  34   a  is adapted for engagement with an engagement structure  16  by providing a hook-like configuration for hooking a cross pin. The distal end  24   b  of the lower elongated member  34   b  is adapted for placement in the recess  28 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0016]    In contrast to previous circumcision clamps, the present invention includes a device that more easily and accurately clamps the foreskin prior to performing a circumcision. As will be envisioned by one skilled the art to which the present invention belongs, the physician or user is able to clamp the foreskin more effectively by closing the arms of the base around the foreskin instead of relying on the user&#39;s ability to thread the foreskin through a fixed aperture. In addition the present invention&#39;s use of a hand-actuated mechanism requires less effort by the operator and induces less torsional stress on the device, thereby increasing the safety and efficiency of the operation. This safety and efficiency is further increased by adapting the actuating structure to securely engage both the rod and the base through the use of the rod&#39;s engagement structure and the base&#39;s recesses and/or throughbores. This invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this application will be thorough and complete, and will fully convey the true scope of the invention to those skilled in the art. 
         [0017]    Referring generally to  FIGS. 1-4 , the circumcision surgical clamp  10  of the present invention includes a rod  12  having at one end an engagement structure  16  and at the opposing end a bell-shaped member  14 , a base  20  including two arms  19   a  and  19   b  hinged  30  at one end and forming at least two apertures  26  when provided in a closed orientation, and an actuating structure  18  for raising the rod  12  such that the bell-shaped member  14  is raised towards the rim of the rimmed aperture  26 . The invention is normally used to perform circumcision operations. 
         [0018]    Referring to  FIG. 2 , at one end of the rod  12 , also referred to as the upper end, exists an engagement structure  16 . The engagement structure  16  allows the actuating structure  18  to engage the rod  12 . The engagement structure  16  may be provided in any configuration that is able to engage an actuating structure  18  such that the actuating structure  18  may exert mechanical force upon the engagement structure  16  and thereby exert such force upon the rod  12 , and thus raise the rod  12 . Engagement typically involves the mating of two complementary surfaces such as tongue and groove, hook and loop, hook and cross pin, rod and aperture and the like. One skilled the art would be able to develop additional engagement structures  16  using the guidance provided herein, which are also encompassed by the present invention. In the preferred embodiment the engagement structure  16  is in the form of a cross pin. The engagement structure  16  may be fabricated then joined to the rod  12  using conventional casting and joining techniques such as welding, gluing and the like. The engagement structure  16  may also be joined to the rod  12  by non-permanent means, such as by insertion of a pin through a hole or aperture traversing the rod  12 . Alternatively the engagement structure  16  may be cast as a single unit (e.g. injection moulded) in combination with the rod  12  using casting methods known to those skilled in the art to which the present invention belongs. 
         [0019]    A bell-shaped member  14  is provided at the end opposite the engagement structure  16 , also referred to as the lower end of the rod  12 . The inner portion  15  of the bell-shaped member  14  accepts the tip of the penis, which allows the foreskin or prepuce to be drawn along the outer portion of the bell-shaped member  14 . The bell-shaped member  14  may be fabricated then joined to the rod  12  or may be cast a single piece using methods known to those skilled in the art to which the device  10  of the present invention belongs. 
         [0020]    Referring to  FIG. 3 , the base  20  includes two arms  19   a  and  19   b  joined at their distal ends by a hinge  30 , which allows the base  20  to reversibly open and close. In some embodiments the base  20  is transparent allowing the practitioner to visually monitor the safety or comfort of the patient or the progress of the procedure. The base  20  provides the primary support for operation of the device  10  and should therefore be constructed from a rigid material. The base arms  19   a  and  19   b  may be constructed from metal, metal alloy such as stainless steel or aluminum, plastic, transparent plastic or any other suitable material. The base arms  19  are then hinged  30  at one end using conventional manufacturing techniques such that the base arms  19  are generally planar. The surface of the base  20  may be continuous or discontinuous and may include a variety of surface features such as recesses  28 , throughbores, raised planes and the like. In alternative embodiments the hinge  30  is replaced by a pivot pin or a rotatable surface. 
         [0021]    When in the closed position, the arms  19  form at least two rimmed apertures  26  having unequal diameters, though the diameters of the rimmed apertures  26  are in all cases greater than the diameter of the elongated portion of the rod  12 , and smaller than the largest portion or outer lip of the bell-shaped member  14 . Alternative embodiments utilize greater numbers of rimmed apertures  26  such as three, four or more, each having a different diameter, though the diameters of the rimmed apertures are in all cases greater than the diameter of the elongated portion of the rod  12 , and smaller than the largest portion of the bell-shaped member  14  of the rod  12 . The variation in size of rimmed apertures  26  allows the device to be used with a wide variety of penis sizes, as the variations in diameter size allows the operator to select the most appropriate aperture  26   a,    26   b  or  26   c  through which to clamp the foreskin, and thus allow a single base  20  to accommodate a multitude of patients. The diameters of the apertures  26  may range from about ¼ inch or about ⅛ inch to about one, two or three inches, with diameters smaller and larger also being encompassed by the present invention. The diameters are preferably different sizes from one another. The rimmed apertures  26  are preferably tapered outwards toward the bottom of the base  20  to at least partially complement a portion of the bell-shaped member  14 . 
         [0022]    The proximal ends of each of the two base members  19  reversibly engage  32  and may reversibly lock. The reversible engagement  32  or locking may be performed using complementary engaging surfaces or reversibly locking surfaces. As shown in  FIG. 3 , in one embodiment a locking means is provided having complementary locking angled teeth. In this embodiment the angled teeth allow the proximal ends to be joined by pushing one set of complementary angled teeth over the corresponding second. Release may occur by twisting or lifting one of the arms  19   a  or  19   b  generally upwards or downwards relative to the other in order to unlock the teeth, then pulling the proximal ends away from one another. The reversible engagement  32  or locking of the base members  19  ensures a stable surface upon which the bell-shaped member  14  of the rod  12  may exert force by pressing against the base  20  as the actuating structure  18  raises the rod  12  through the aperture  20 . 
         [0023]    Around or in the vicinity of the rimmed apertures  26  are recesses  28  or throughbores for insertion of the actuating structure  18  (e.g. the distal end  24   b  of the lower elongated member  34   b ). Recesses  28  are arranged in the vicinity of the rimmed apertures  26 . The recesses  22  may be curved or arced, and may follow a portion of the perimeter of the rimmed aperture  26 . In another alternative embodiment, the recesses  28  comprise a single, continuous groove surrounding the rimmed apertures  26 . In another alternative embodiment, the recesses  28  are non-linear, such as circular or rectangular. The recesses  28  may be provided in any configuration that is able to receive an actuating structure  18  such that the actuating structure  18  may be securely positioned on the base  20  to raise the rod  12  through the aperture  26 . Recesses  28  may be formed by drilling or milling into the base  20  to form a desired shape or depth, or alternatively the base  20  may be cast or injection-molded such that the recesses  28  are thereby created. 
         [0024]      FIG. 4  depicts the preferred embodiment of the actuating structure  18 . The actuating structure  18  includes two elongated members  34   a  and  34   b  hinged  36  near their midpoints or mid sections. The term “near their midpoints or mid sections” as used herein refers to the portion of the elongated members  34  that is between the distal end  24  and proximal end  22 . The members  34  are arranged such that when the proximal ends  22  are maximally proximate and substantially parallel, the distal ends  24  are maximally opposed. The actuating structure  18  may be constructed using methods and materials known in the medical arts such as those used in the construction of hemostats and handheld retractors. As non-limiting examples, the actuating structure  18  may be constructed from metal, metal alloy such as stainless steel or aluminum, plastic and the like. 
         [0025]    The proximal ends  22  form a handle  36  allowing the user to squeeze the proximal ends  22  together to raise the rod  12 . Each proximal end  22  may be contoured for placement of a finger or thumb such as incorporating a finger loop. The proximal end  22  may further include a locking structure  38  allowing the actuating structure  18  to be locked in the closed or squeezed position such that the distal end  24   a  of the upper elongated member  34   a  raises the rod  12 . Such locking structures  38  are known in the medical arts, for example those incorporated on hemostats, hand held retractors and the like, which are incorporated by reference and encompassed within the present invention. 
         [0026]    One of the members (also referred to as the lower member)  34   b  is adapted at its distal end  24   b  for insertion into a recess  28  or throughbore in the base arm(s)  19 . The distal end  24   b  of the lower member  34   b  stabilizes the actuating structure  18 . The adaptation may be provided in a variety of configurations such as having a downward protrusion or a generally arced configuration as provided in  FIG. 4  or any other configuration that ensures a secure engagement between the distal end  24   b  and the recesses  28 . The configuration of the lower member&#39;s distal end  24   b  depends on the configuration of the corresponding recess  28  or throughbore. The configuration should be generally complementary. One skilled in the art to which the present invention belongs would recognize that the distal end  24   b  of the lower member  34   b  may include a single end for insertion into a single recess  28  or throughbore or a forked end having one or more forks for insertion into two or more recesses  28  or throughbores. The present invention includes a distal end  24   b  including one or more portions for insertion into one or more recesses  28  or throughbores for stabilization of the present invention. In the preferred embodiment the distal end  24   b  has an arc-like configuration that is complementary to a recess  28  having an arc-like configuration. In the preferred embodiment the actuating structure  18  is positioned approximately perpendicular to the base  20 . Also preferred is a distal end  24   b  and complementary recess  28  that affect both arms  19  of the base  20  such that the distal end  24   b  applies force against each of the two arms  19 . 
         [0027]    The other member (also referred to as the upper member)  34   a  is adapted at its distal end  24   a  to engage the engagement structure  16  and thereby manipulate the rod  12  through one of the at least two rimmed apertures  26 . The distal end  24   a  of the upper member  34   a  is provided in a configuration that is capable of the engagement with the engagement structure  16  such as having a complementary surface. In the preferred embodiments, the upper member  24   a  is adapted for placement under the engagement structure  16  such as a two pronged hook positionable under a cross pin or under a spherical engagement structure and the like. Therefore in the preferred embodiments the distal end  24   a  of the upper member  34   a  is actuated such that it lifts the rod  12  upwards however the present invention also includes embodiments where the upper member  34   a  is positioned above the rod  12  and pulls the rod  12  upwards. In further embodiments, the actuating structure  18  may include additional features such as an upward protrusion on the lower member to assist in pulling back the foreskin or prepuce for placement around the bell-shaped member. 
         [0028]    In another aspect of the present invention a circumcision kit is disclosed including the circumcision clamp  10  of the present invention and one or more surgical tools such as a scalpel, a hemostat, forceps, a dressing, disinfectant, and the like. The kit may be provided as a one time use kit or may be sterilized such as by autoclave one or more times for routine use. 
         [0029]    In another aspect of the present invention a method of performing a circumcision is provided including providing the circumcision clamp of the present invention, placing the head of a patient&#39;s penis in the bell-shaped member, pulling the foreskin over the outer portion of the bell-shaped member, closing the base around the bell-shaped member covered with the foreskin, inserting one of the distal ends of the actuating structure in the recess of the base and the engaging the rod&#39;s engagement structure with the opposing distal end, squeezing the handle the actuating structure to raise the bell-shaped member against the rimmed aperture, and cutting the foreskin above the base.