Abstract:
A self adjusting pressure applicator that can be used to retain tissue without causing injury to the tissue and that allows for repositioning of the retained tissue. Such a device can be used in conjunction with a circumcision clamp or other surgical instrument to ensure accurate positioning of the tissue prior to surgical manipulation. When used with a circumcision clamp such a device can ensure accurate removal of the desired amount of tissue resulting in improved surgical outcomes.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present invention claims benefit of U.S. Provisional Application Ser. No. 60/816,798, entitled “SELF-ADJUSTING PRESSURE APPLICATOR” filed on Jun. 26, 2006, which is incorporated herein. 
     
    
     FIELD OF THE INVENTION  
       [0002]     One embodiment of the present invention is related generally to the field of skin or tissue retention, and more particularly to a device for holding foreskin prior to the crushing and cutting associated with circumcision or other surgical procedures.  
       BACKGROUND OF THE INVENTION  
       [0003]     Newborn circumcision is the most commonly performed surgical procedure in the World with an estimated 5 million circumcisions performed annually. Adult circumcisions are also performed routinely around the world. Circumcision has been performed for centuries for both religious and medical reasons. Circumcision instruments should, among other characteristics, provide a repeatable and a consistent level of hemostasis to help control bleeding and provide a method to safely and accurately incise the desired amount of foreskin tissue.  
       SUMMARY OF THE INVENTION  
       [0004]     According to the invention, there is provided a self-adjusting pressure applicator, as defined in claims  1 - 19 .  
         [0005]     For a better understanding of the present invention, together with other and further objects thereof, reference is made to the accompanying drawings and detailed description. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0006]     The present invention is illustratively shown and described in reference to the accompanying drawings, in which:  
         [0007]      FIG. 1A  is a perspective view of one embodiment of the present invention shown in the up position or disengaged;  
         [0008]      FIG. 1B  is a perspective view of one embodiment of the present invention shown in the down or engaged position;  
         [0009]      FIG. 2  is a perspective view of an exemplary foreskin holder of the present invention of  FIG. 1 ;  
         [0010]     FIGS.  3 A-B are side views of the foreskin holder of  FIG. 2 ;  
         [0011]      FIG. 3C  is a bottom view of the foreskin holder of  FIG. 2 ;  
         [0012]     FIGS.  4 A-C illustrate the assembly of the foreskin holder of  FIG. 2  on to an exemplary embodiment of the ring component;  
         [0013]      FIGS. 5, 6 ,  7 , and  8  are pictorial views of the ring component being inserted into the foreskin of a penis;  
         [0014]     FIGS.  9 A-C illustrate the positioning of foreskin between the foreskin holder and the ring component of FIGS.  4 A-C;  
         [0015]      FIG. 10  are pictorial views illustrating use of the present invention with a clamping-cutting device;  
         [0016]      FIG. 11A  illustrates a cross section of the foreskin being held in position by the present invention prior to clamping and cutting by the clamping-cutting device of  FIG. 10 ;  
         [0017]      FIG. 11B  illustrates a cross section in the crushing and cutting position.  
         [0018]      FIG. 11C  demonstrates a bottom view of just the retractable arms in the open, neutral position.  
         [0019]      FIG. 11D  demonstrates a bottom view of just the retractable arms in the closed, clamping position.  
         [0020]      FIGS. 12A  is an illustration of the present invention of  FIG. 1  adapted for use with a conventional circumcision clamp; and  
         [0021]      FIG. 12B  is an illustration of the present invention of  FIG. 1  adapted for use with a conventional circumcision bell. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0022]     The following disclosure of the present invention illustrates the self-adjusting pressure applicator adapted for use with a circumcision tool. However, it is contemplated within the scope of the invention for uses on any tissue such as brain or neuron tissue or cardiac vessel, as well as foreskin. Therefore, the invention should not be limited to use with only a circumcision tool as disclosed.  
         [0023]     One embodiment of the present invention  10 , illustrated in  FIGS. 1A and 1B , includes ring component  12  and foreskin holder  14 .  FIGS. 1A and 1B  illustrate ring component  12  and foreskin holder  14  in the disengaged and engaged positions, respectively. Ring component  12  is a single, one-piece, solid member made from, for example, injection molding of a malleable, elastic material (such as plastic) with an open ring  16  mounted orthogonally to lower shaft  18  by curved member  20 , which allows manipulation of ring  16  within the foreskin. Ring component  12  includes a position adjustor  34  that delineates the lower shaft  18  from the upper shaft  36 . Ring  16  can include an opening or gap  30  large enough to allow the thickness of the foreskin to enter. Ring  16  can include an inner diameter  32  large enough to receive a predetermined sized glans and shield the glans or head of the penis from being clamped and/or cut. Lower Shaft  18  (not shown) and/or upper shaft  36  (shown) can include a plurality of diameters  22 A,  22 B to control the insertion of ring component  12  into a clamping-cutting device  200  (disclosed in PCT international application PCT/US2005/022404 and incorporated herein by reference). A shaft diameter change can be delineated by a notch or ledge or, as illustrated in  FIG. 1A , shoulder  24  that acts as a stop of ring component  12  into clamping-cutting device  200  (see  FIG. 10 ).  
         [0024]     Now turning to FIGS.  11 A-D, ring  16  includes a holding/cutting surface  26  on its top surface being adapted to act as a holding surface when foreskin holder  14  is engaged and a cutting surface when cutting edge  202  of blade  204  of clamping-cutting device  200  is pressed down against foreskin  15  interposed between holding/cutting surface  26  and cutting edge  202 . Ring  16  may also include grooved outer surface  28  adapted to engage with inward radial extension  206  of retractable arm  208  to hold ring component  12  in a stationary position relative to clamping-cutting device  200  (See  FIG. 11 ) during the clamping/cutting operation, such that the foreskin  15  is trapped between the grooved outer surface  28  and the radial extension  206  of the retractable arms  208  (See  FIG. 11 ). Grooved outer surface  28  will interact with inward radial extension  206  to crush the foreskin against grooved outer surface  28  and contemporaneously hold ring component  12  in position while circular blade  204  is delivered to make the incision in the foreskin.  
         [0025]     Now returning to  FIGS. 1A and 1B , one example of the present invention illustrates position adjustor  34  that cooperates with malleable, spring-like opposing arms  38  of foreskin holder  14  to apply a hands-free self-adjusting constant pressure force upon the foreskin disposed between lower surface  40  of foreskin holder  14  ( FIGS. 1A  and B) and holding/cutting surface  26  of ring component  12 . Malleable arms  38  and position adjustor  34  act as pressure force generators. This arrangement provides for flexibility in positioning the foreskin prior to cutting while maintaining a predetermined pressure force. One embodiment for the present invention applies a pressure force between 50 and 200 grams to the tissue when engaged. Another embodiment applies a pressure force of about 181 grams of force to the tissue when engaged. The pressure force is exerted along a common centerline of ring component  12  and foreskin holder  14 .  
         [0026]     One embodiment of the present invention is engaged only long enough to insert the present invention  10  into the clamp, activate the clamp or otherwise cut the foreskin, thereby removing the retained foreskin from the patient. For example, the present invention can be engaged ranging from about 30 seconds to about one minute, the foreskin can be positioned between the two components, the clamp applied, and the retained foreskin crushed and excised. The agility, flexibility, and simplicity of the present invention allows for repositioning of the foreskin to assure substantially full or entire circumferential retention of the foreskin or tissue. Such minor adjustments can be made with great precision within a short period of time and with no tissue damage. Providing full circumferential retention of the foreskin or tissue along the crushing and cutting surface results in an improvement of the surgical removal of the foreskin or tissue without the use of barbs, pins, clips, or hemostats.  
         [0027]     Another embodiment of the present invention applies the pressure force indefinitely to the tissue being retained allowing for prolonged surgical manipulation of that tissue without causing permanent injury.  
         [0028]     One embodiment of position adjustor  34  is generally a circular body, having a tapered surface, and can be, for example, in the form of two unequal half spheres (similar to football halves) that create a shoulder or lip  42  when joined together. An upper half sphere  44  can have a diameter at the joining interface  48  larger then the mating diameter of lower half sphere  46 . Spheres  44 ,  46  each have a tapered surface to facilitate the upward and downward movement of malleable arms  38  on the spheres  44 ,  46 . The shoulder  42  formed at interface  48  acts as a malleable arm stop to inhibit the upward progress of malleable arms  38  as the foreskin is pulled upward to position it for crushing and cutting. The malleable arms  38  must be spread open to fit over shoulder  42  and into the disengaged position. The concave configuration of malleable arms  38  can be sized and shaped similar to spheres  44 ,  46  for containment of the foreskin holder  14  while in the disengaged position ( FIG. 1A ) and for spring-back properties while in the engaged position ( FIG. 1B ). The tapered surface of lower sphere  46  can be sized and shaped to provide the desired predetermined pressure force taking into consideration the spring-back force of malleable arms  38 . Malleable arms  38  must always be in contact with lower sphere  46  to maintain a constant predetermined pressure on to the foreskin when foreskin is disposed between lower surface  40  of foreskin holder  14  and holding/cutting surface  26  of the ring component  12 .  
         [0029]     In furtherance of the description to hold foreskin in a precise location, when the foreskin holder  14  is positioned in the down or engaged position, malleable arms  38  of the foreskin holder  14  interact with the lower tapered surface  46  of position adjustor  34  forming a spring-like mechanism to create a force in the direction towards holding/cutting surface  16  and away from position adjustor  34 . The spring-like mechanism exerts a force that holds foreskin holder  14  in place along the holding/cutting surface  26  of ring component  12 . The pressure force in turn holds the foreskin in place that is positioned between the holding/cutting surface  26  and the foreskin holder ring portion  56 . Ring portion  56  at the base of the foreskin holder  14  applies a 360° circumferential force to the holding/cutting surface  26  to achieve a substantially constant circumferential pressure or holding force. Shoulder  42  of the position adjustor  34  along interface  48  acts as a latch allowing for malleable arms  38  to move down lower shaft  18 , but prevents inadvertent movement of foreskin holder  14  back up into the disengaged position. Shoulder  42  ensures that malleable arms  38  and lower tapered surface  46  maintain in an axial position that generates the spring-like force holding the foreskin holder  14  in place relative to holding/cutting surface  26  of ring component  12 . Ring portion  56  of foreskin holder  14  is preferably supported by two support arms  58  (discussed in detail below) that allow for easy visibility and access to the foreskin that becomes retained within the cavity  61  of foreskin holder  14 .  
         [0030]     Now turning to  FIG. 2  for a complete discussion of foreskin holder  14 . One example of the foreskin holder  14  is a single, one-piece, injected molded, solid member constructed of malleable, elastic material (such as plastic). As mentioned above, foreskin holder  14  includes a ring portion  56 , a pair of support arms  58 , a C-shaped sleeve  60 , and a pair of malleable arms  38 . Ring portion  56  is configured to align juxtaposition to the holding/cutting surface  26  of ring  16  (see  FIG. 1A ) of the ring component  12 . Ring portion  56  is general circular with an inner diameter  32 , outer diameter  72 , a bottom surface  40 , and a top surface  64 . Bottom surface  40  is a pressure surface that contacts and applies pressure to the foreskin disposed between the holding/cutting surface  26  of the ring component  12 .  
         [0031]     As discussed above, malleable arms  38  will exert a downward force caused by its interaction with a position adjustor  34  on the modified ring component  12 . The spring coefficient of the malleable arms  38  can be derived by well known methods to accommodate the desired pressure force. The desired pressure force can be determined by knowing, among other characteristics, thickness of tissues including but not limited to foreskin, brain or neuron tissue, or cardiac vessel. The downward force is translated through C-shaped sleeve  60  to support arms  58 . Supports arms  58  applies the translated force to ring portion  56  at interconnect points  66 . The force will be substantially evenly distributed along lower surface  40  when lower surface  40  is in contact with foreskin disposed between lower surface  40  and holding/cutting surface  26  of the ring component  12 . The force or contact pressure distribution along to lower surface  40  is a function of width W of support arms  58  and the rigidity of ring portion  56 . For example, the wider the support arms  58 , the more ring portion surface area in the direct load path of the translated force. Ring portion  56  would bend less when the ring portion  56  is more rigid. Bending of ring portion  56  could cause a reduction of the contact pressure along lower surface  40  as a function of circumferential distance from the interconnect points  66 .  
         [0032]     Though a pair of independently deflectable malleable arms have been used to illustrate a spring-like mechanism to apply a pressure force, it should be appreciated that there are many suitable combinations of arm (deflectable or rigid) or spring-like mechanisms incorporated into the body of the position adjustor  34  that will achieve the desired results. The invention should not be limited to only the embodiments disclosed in this application.  
         [0033]     Now turning in FIGS.  3 A-C, one embodiment of a support arm  58  can include one or more sections. Shown as an example is support arm  58  having two sections  58 A,  58 B. Two support arms  58  provides for easier visibility and access to the foreskin that becomes retained within the foreskin holder  14 . Section  58 A is attached at one of its ends  58 C to either top surface  64  or to the inner diameter  33  ( FIG. 3C ) or to the outer diameter  72 . One embodiment of Section  58 A can be oriented orthogonal to ring portion  56 . However any angle α ( FIG. 3B ) that applies evenly distributed forces along lower surface  40  of ring portion  56  is acceptable. Section  58 B is attached at a predetermined angle Ø at one of its ends  58 E to the other end  58 D of section  58 A, and at its other end  58 F to C-shaped sleeve  60  at its end  60 A at a predetermined angle β. The angular relationships between sections  58 A and  58 B and C-shaped sleeve  60  create an inward taper of support arms  58 . The predetermined angles α, Ø, and β, and therefore the support arm taper, can be variable to accommodate the independent optimization of ring portion  56  and C-shaped sleeve  60 , and/or to optimize the contact pressure along lower surface  40 . In the case where Ø is 180°, there will only be one section  58 . Though the preferred number of support arms is two, any number of support arms is acceptable and within the contemplation of the invention.  
         [0034]     Continuing with the embodiment illustrated in  FIG. 3B , each malleable arm  38  is attached at one of its ends  38 A to end  60 B of C-shaped sleeve  60  and its other end  38 B is free to independently flex or deflect (X) and form a gap (Y) at rest. Free ends  38 B can deflect to predetermined distance X under predetermined load or force conditions (discussed in detail below). The flexed or deflected malleable arms act like a spring storing energy to produce a spring back force, which is a function of the deflection distance X. The larger the deflection distance X, the more spring-back force will be created. Since the spring back force is also a function of the materials property, for example the modulus of elasticity, material selection is also important in determining the desired spring back force. It will become apparent later in this application that the spring back force will act upon a position adjustor  34  of ring component  12  to result in a downward movement of foreskin holder  14  that applies the pressure force to the foreskin disposed between lower surface  40  and holding/cutting surface  26  of ring component  12 . Malleable arms  38  can be of any configuration that results in the desired spring back force working in conjunction with position adjustor  34  of ring component  12 . For example, malleable arms  38  can have a concave surface  54  and be opposingly oriented to each other. As discussed above, the type of materials, dimensions (thickness, width, length) of malleable arms  38 , and/or shape of malleable arms  38  (concave or convex) are derivable from the desired pressure force to be applied to a target tissue, such as foreskin, brain or neuro tissue, or cardiac vessel.  
         [0035]     Now turning to  FIG. 3C , C-shaped sleeve  60  in generally cylindrical in shape and hollow having an outer diameter  60 C, an inner diameter  60 D, and two circumferential ends  60 E, which form slot  60 F with gap  60 G. Gap  60 G is less than inner diameter  60 D of C-shaped sleeve  60  and less than the outer diameter  76  of lower shaft  18  of ring component  12  ( FIG. 1A ). C-shape sleeve  60  has sufficient elastic properties such that gap  60 G will open as lower shaft  18  is inserted through slot  60 F and gap  60 G will close or return to its original gap distance  60 G after insertion of lower shaft  18  into slot  60 F. Once lower shaft  18  is inserted through slot  60 F, it is trapped or entrained within C-shaped sleeve  60  and only permitted to move along in a longitudinal path within C-shape sleeve  60  because outer diameter  76  is smaller than inner diameter  60 D to allow for lower shaft  18  to move longitudinally within inner diameter  60 D. Ends  60 E can be rounded to facilitate easier insertion of lower shaft  18  through slot  60 F. FIGS.  4 A-C illustrate foreskin holder  14  (female component) being positioned on ring component  12  (male component) ( FIG. 4A ), alignment of slot  60 F of foreskin holder  14  with lower shaft  18  of ring component  12  prior to insertion ( FIG. 4B ), and foreskin holder  14  slidably connected with ring component  12  after insertion of lower shaft  18  through slot  60 F ( FIG. 4C ).  
         [0036]     One embodiment of outer diameter  60 C can include finger grips  60 H to facilitate a better grip for raising and lowering foreskin holder  14  relative to ring component  12 . Finger grips  60 H can be one or more projections. As shown in  FIGS. 3A and 3B , three projections  60 H are circumferentially oriented parallel to each other along outer diameter  60 C. Any cluster or grouping of projections are acceptable as well as any surface treatment that creates a frictional condition between the user&#39;s fingers and outer diameter  60 C.  
         [0037]      FIGS. 5, 6 ,  7 , and  8  demonstrate an example of the insertion of ring  16  into the foreskin  15 . As discussed above, gap  30  allows entry of ring  16  into foreskin  15 . Foreskin  15  is held by an atraumatic forceps  13  while gap  30  is positioned to enter foreskin  15 . With a pair of non-traumatic forceps, the foreskin is gently grasped and foreskin  15  is guided into the gap  30  of ring  16 . With a screw-like motion of lower shaft  18  of ring component  12 , the ring  16  is advanced in, down, and around the inner aspect of the foreskin  15 . The gap  30  in ring  16  allows the ring  16  to be advanced into the foreskin with a smooth, non traumatic fluid screwing motion. Once ring  16  is fully inserted and resides just beneath foreskin  15 , it can be pushed down slowly toward the glans to free any adhesions but to be surrounded by foreskin  15 . Inside foreskin  15 , gap  30  is closed by the elastic nature of the foreskin  15  attempting to return to its state after being stretched during the insertion of ring  16 . The closed ring  16 , inside the foreskin of the penis, residing just above the glans or tip of the penis, is then used as the compressive surface for any number of clamps, such as inward radial extension  206  ( FIG. 11A ), and its top surface  26  acts as a combination glans shield, cutting surface for blade  204  as it cuts the foreskin, and foreskin holder when cooperating with foreskin holder  14 .  
         [0038]     FIGS.  9 A-C illustrate the operation of foreskin holder  14  after foreskin is positioned on the ring  16  of ring component  12  (hidden beneath foreskin  15 ). The operator pinches or grips finger grips  60 H of foreskin holder  14  and pushes foreskin holder  14  down towards holding/cutting surface  26  (hidden beneath foreskin  15 ) ( FIG. 9A ). The dashed line represents the desired circular foreskin cutting circumference. Malleable arms  38  automatically open as malleable arms  3   8  move down upper sphere  44  and then automatically close as malleable arms  38  transition to move down lower sphere  46 . The operator uses forceps  13  to grab the foreskin  15  for initial positioning for a substantially circular cut, shown as a dashed line ( FIG. 9B ). After initial positioning, the operator pulls the foreskin  15  substantially upwards (FIG.  9 C). Foreskin holder  14  may advance upward on to lower sphere  46 . As foreskin holder  14  advances upward the spring back force of malleable arms  38  increases and the downward pressure increases to counter the upward pull on the foreskin and to maintain a substantially constant circumferential pressure force onto the foreskin. Repositioning of the forceps may be necessary to assure the foreskin is evenly distributed around holding/cutting surface  26  of ring component  12  (hidden beneath foreskin  15 ) for a substantially circular cut (dashed line).  
         [0039]      FIG. 10  illustrates one embodiment of the present invention  10  adapted for use with a circumcision clamping-cutting device  200  (disclosed in PCT international application PCT/US2005/022404 and incorporated herein by reference) adapted to cooperate with each other. Step A: Ring  16  (hidden beneath foreskin) of ring component  12  is inserted into the foreskin  15  of the penis, as discussed above. Step B: Clamping-cutting device  200  is set in the open position with lever arm  212  rotated up and retractable arms  208  extending fully through the bottom of housing  210  and sleeve  214 . Step C: Clamping-cutting device  200  is inserted onto upper shaft  36  of ring component  12 . Downward movement of clamping-cutting device  200  and housing  210  onto upper shaft  36  is stopped when shoulder  24  contacts bottom face of an internal thru hole (not shown). Step D: Lever arm  212  is activated downward to advance sleeve  214  downward over retractable arms  208  causing the clamping force and delivering the internal circular blade  2 O 4  ( FIG. 11A ) to the foreskin  15 . Sleeve  214  moves downwardly over retractable arms  208  causing retractable arms  208  to radially close on to and to exert lateral compressive force against the foreskin  15 . Turning to  FIGS. 10 and 11 A and B, retractable arms  208  exert sufficient lateral compressive force or clamping such that inward radial extensions  206  ( FIG. 11A ) of retractable arms  208  forces the foreskin  15  into grooved outer surface  28  of ring  16 , thereby clamping the foreskin  15 . As sleeve  214  is advanced even further over the ring  16 , blade  204  is delivered to the top surface  64  of ring  16  and creates the circular incision into the foreskin  15  when ring  16  is positioned within clamping-cutting device  200  ( FIG. 11B ). Using the top surface  64  of ring  16  as the cutting surface that is held in place by the closed retractable arms  208 , blade  204  makes a single, clean, circumferential incision on top surface  64  of ring  16 , removing the excess foreskin  15 . The clamp is left in place for a period of time ensuring adequate crushing and hemostasis. Step E ( FIG. 10 ): Lever arm  212  is lifted upward and retractable arms  208  release ring component  12 , lifting sleeve  214  of the clamping-cutting device  200  and lifting blade  204  back up into housing  210  and releasing ring  16 . Ring component  12  with severed foreskin is permanently locked within housing (not shown)  210  to prevent inadvertent reuse of any of the components of the device. All components and byproducts of the operation are thrown away, thereby completing the circumcision.  
         [0040]      FIGS. 11C and 11D  show a bottom view of the clamping arms  208  with radial extensions  206  by themselves in the open, neutral position and the closed, clamping position, respectively.  
         [0041]      FIG. 12A  illustrates the present invention  10  and a conventional type clamp  300 , which includes plate  302 , nut  304 , yolk  306 , and bell/stud  308 , adapted to cooperate with each other.  
         [0042]      FIG. 12B  illustrates the present invention  10  and a conventional type bell  400  adapted to cooperate with each other  
         [0043]     Further embodiments of the above disclosed components are disclosed U.S. patent application Ser. No. 11/571,120 filed on Dec. 21, 2006, “Atraumatic Circumcision Device and Method to Use”, by David R. Tomlinson, which is a U.S. national phase entry of Patent Cooperation Treaty international application serial number PCT/US2005/022404 filed on Jun. 23, 2005, “Atraumatic Circumcision Device and Method to Use”, by David R. Tomlinson, which claims priority to U.S. provisional application Ser. No. 60/583,259 filed on Jun. 25, 2004, “Atraumatic Circumcision Ring and Method”, by David R. Tomlinson, whereby all above listed applications are herein incorporated by reference.  
         [0044]     While the disclosure has been described in detail and with reference to specific embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the embodiments. Thus, it is intended that the present disclosure cover the modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents.