DEVICE FOk CIRCUMCISION

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

[0001] This application claims priority from Provisional Application US Application 61/064,552, filed 3/11/2008, incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

[0002] The present disclosure relates generally to the field of devices and methods for circumcision. The disclosure more specifically relates to devices and methods for male circumcision.

[0003] Male circumcision (MC) is an operation to remove at least a part of the foreskin (prepuce) from a penis. Many devices and methods have been developed to conduct circumcision, though the most common methods currently used are over 50 years old.

[0004] The World Health Organization (WHO) has advocated MC as a viable tool to help reduce the HIV/ AIDS pandemic in Africa. Most male circumcisions (MC) in Africa are performed using a forceps guided method without a specialized circumcision device. This is a standard surgical approach that is typically accompanied by more profuse bleeding, requires more stitches, and requires more time for suturing than with other methods.

[0005] The three most common MC devices are the Gomco® clamp, the Mogen clamp, and the Plastibell®. The Gomco® and Mogen devices are "temporary clamps" placed on the foreskin to facilitate the operation and are removed once completed (typically less than 20 minutes). The Plastibell® device is a "necrosing clamp" that includes at least some part that remains on the foreskin after the surgical procedure while the tissue dies (or necroses) over a period of several days.

[0006] The Gomco® clamp requires suturing in adults, cutting the foreskin around the device requires manual skill, and many pieces are used in the clamp that are typically custom fitted and prone to wear. When using the Mogen clamp, the glans is typically not well protected; it is possible to capture the glans in the device. Additionally, the Mogen clamp does not remove as much inner foreskin as other devices and suturing is required in adults.

[0007] When using the Plastibell clamp, part of the device is worn for several days following the operation and the tie can slip off the bell and damage the glans or shaft of the penis. Many other necrosing clamps are currently available and they may be "horizontal" (e.g., including an internal ring) or "vertical" (e.g., including an internal tube). Horizontal clamps include the Plastibell, the Sunathrone™ clamp, the Kirve® Klamp, and the Zhenxi Circ-Ring™. Vertical clamps include the Tara KLamp®, the Smart Klamp®, the Ismail Clamp™, and the ALI'SKLAMP®.

[0008] Existing clamps are typically not well suited to address the African market because they do not offer adequate safety (e.g., during the operation, after the operation, etc.) and they require too much operator skill.

SUMMARY

[0009] One embodiment relates to a circumcision device for cutting the foreskin of a male. The circumcision device comprises a protection tube configured to be placed inside the foreskin, the tube including a main portion having a smooth outer surface and a protruding clamping ring located at a base of the tube. The circumcision device further comprises an inner clamp configured to clamp the foreskin between the clamping ring and the inner clamp; an exterior clamping device surrounding the inner clamp and including a mechanism for securing the exterior clamping device in a fixed position; and a cutting device for cutting the foreskin. The cutting device is configured to be mounted to the exterior clamping device. A cutting depth of the cutting device is adjustable. The circumcision device is configured so that after the foreskin is cut the exterior clamping device and the main portion of the protection

tube may be removed while the inner clamp and the clamping ring remain in position clamping the foreskin to the clamping ring.

[0010] Another embodiment relates to a circumcision device for cutting the foreskin of a male. The circumcision device comprises a protection tube configured to be placed inside the foreskin, the protection tube including a main portion having a smooth outer surface and a clamping ring located at a base of the tube. The circumcision device further includes an inner clamp configured to clamp the foreskin between the clamping ring and the inner clamp; an exterior clamping device surrounding the inner clamp and including a mechanism for securing the exterior clamping device in a fixed position; and a cutting device configured to be mounted to the exterior clamping device. The cutting device includes a blade for cutting the foreskin. The circumcision device is configured so that after the foreskin is cut by the cutting device the exterior clamping device and the main portion of the protection tube may be removed while the inner clamp and the clamping ring remain in position clamping the foreskin to the clamping ring.

[0011] Still another embodiment relates to a circumcision device for cutting the foreskin of a male. The circumcision device comprises a protection tube configured to be placed inside the foreskin, the protection tube including a main portion having a smooth outer surface and a clamping portion located at a base of the tube. The circumcision device further comprises a clamping device configured to clamp the foreskin between the clamping portion and the clamping device so that the foreskin is secured in position to be cut using a cutting operation. The protection tube includes needle guides slots so that after the cutting operation is complete the remain portion of the foreskin may be stitched by passing a needle and suture through the guide slots.

[0012] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only, and are not restrictive of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The invention will become more fully understood from the following detailed description, taken in conjunction with the accompanying drawings, wherein like reference numerals refer to like elements, in which:

[0014] FIG. 1 is an isometric view of a circumcision device including a rotation scalpel and small clamping band according to an exemplary embodiment.

[0015] FIG. 2 is a side view of a protection tube for the circumcision device of FIG. 1 according to an exemplary embodiment.

[0016] FIG. 3 A is a top view of an inner clamp and clamping ring for the circumcision device of FIG. 1 after an operation according to an exemplary embodiment.

[0017] FIG. 3B is a side view of an inner clamp and clamping ring for the circumcision device of FIG. 1 after an operation according to an exemplary embodiment.

[0018] FIG. 4 is a schematic top view of a circumcision device according to an exemplary embodiment showing a range of cut diameters possible using the device.

[0019] FIG. 5 is an isometric view of a circumcision device according to another exemplary embodiment, including a garrote cutter.

[0020] FIG. 6 is a top view of a procedure platform for a circumcision device according to an exemplary embodiment.

[0021] FIG. 7 is a schematic top view of the circumcision device of FIG. 5 according to an exemplary embodiment showing a range of cut diameters possible using the device.

[0022] FIG. 8 is a top view of a clamp and cord positioning device for a circumcision device according to another exemplary embodiment.

[0023] FIG. 9 is a side view of a protection tube for the circumcision device of FIG. 1 according to an exemplary embodiment including a clamping ring with a groove.

[0024] FIG. 10 is a top view of a circumcision device according to another exemplary embodiment, including a plurality of blade in iris cutter arrangement.

[0025] FIG. 11 is a top view of a circumcision device according to another exemplary embodiment, including a plurality of rotating blades on pivoting arms.

[0026] FIG. 12 is a side view of a protection tube for a circumcision device including a plurality of weakened regions.

[0027] FIG. 13 is a side view of a protection tube for a circumcision device including guide slots for a suture.

[0028] FIG. 14 is a side view in partial cross-section of a circumcision device including a protection tube and clamping device, the clamping device is shown in cross-section.

[0029] FIG. 15A is a side view in partial cross-section of a circumcision device including a protection tube and clamping device, the clamping device is shown in cross-section.

[0030] FIG. 15b is a top view of a clamp for the circumcision device.

[0031] FIG. 16 is a side view of a protection tube for a circumcision device including guide slots for a suture.

DETAILED DESCRIPTION

[0032] According to various exemplary embodiments, a circumcision device may include a procedure platform that provides increased protection for the patient and security for the clinician when performing the circumcision. Part of a necrosing or temporary clamp may be removable allowing the procedure platform to be larger and more useful. The clamp may be smaller than with typical devices to provide a better

post-op experience. A larger base area or protective guard can shield the patient from cuts or other procedure problems and provide an area for clinician or device support (e.g., extra room for an interlock with a safety blade). In a necrosing device, part of the platform may remain behind for the necrosing period (e.g., a bikini clamp), but most is removed. The inner guard that protects the glans (e.g., a hard protective tube) can hold the removed foreskin for disposal after cutting. The amount of foreskin removed may be controlled to maximize the amount of HIV protection available via circumcision.

[0033] The circumcision device may include a rotational cutter as a simple alternative to a scalpel. A conventional device uses an open scalpel for cutting the foreskin, but using a rotational blade may simplify the cutting process and make it more repeatable. The blade or set of blades may include, for example, a rolling cutter or an enclosed garrote in a generally doughnut shape. Therefore, a scalpel or other sharp device may not be required. The device may provide more consistent results as it is not operator dependent (e.g., the first cut of the day may be the same as the last).

[0034] The circumcision device may include a safety blade or be manipulated by a set of methods intended to prevent accidents and reuse of sharp objects. For example, as a complement to the rotational cutter, the cutter housing may include interlocks that prevent blade deployment until the cutter is in proper position. Once removed from the procedure platform the interlocks may engage an auto-destruct mechanism, locking the sharp blade in the cutter housing. The auto-destruct mechanism may prevent or reduce the reuse of dirty blades and eliminate or reduce the sharp object hazard even in remote areas. The device may include an automatic cut mechanism that allows lower skilled staff to use the device in an effective manner.

[0035] The circumcision device may be configured to fit a vast majority or all of a population of patients (e.g., an adult population, a child population, the entire population, etc.) to help reduce supply line issues as conventional devices are typically sold in individual sizes. Parts for all sizes may be included in a single box or kit. For example, the part that remains behind on the bikini clamp may be included in

three sizes, while only one procedure platform may be needed. The internal glans protection tube could be a single tube scored to adjust to the different sizes required. The tube may be broken off at the scores for the different sizes. The device parts may be disposable so there is not a need to autoclave the device. The device may manipulated by a relatively simple operation, for example by placing, clamping, cutting, and removing.

[0036] The circumcision device may include a guided closure configured to provide assistance for a suturing step. With temporary clamps, the suturing process is typically the most time consuming and difficult part of the procedure. By having the temporary clamp remain engaged during the suture process the bleeding may be reduced (e.g., with the only blood from the foreskin)while simplifying the process. The clamp can include guide features for the suture needle, making the process simpler and easier to learn. The suture step may be moved from a clinician workload if assistants can be effectively trained. The closure may allow non-suture closures (e.g., glue or other adhesive) to be effective. The device may include a protective tube in place during suturing to provide protection for the patient from the needle. The guided closure may allow the operation to be completed at end of the visit with the cut and sutured closed. The guided closure may be disposable and/or durable (i.e., reusable) as desired by the clinician or staff.

[0037] The circumcision device may include interchangeable parts such as a durable clamp with tighter manufacturing tolerances. Conventional temporary clamps may be well made devices, but are typically not tightly toleranced and the parts cannot be used interchangeably. This is a particular issue where many sizes may be required, for example as with a Gomco clamp. The clamp of the device may include fully interchangeable parts. The parts may be durable (i.e., reusable) for areas that might have supply line issues

[0038] According to an exemplary embodiment, the procedure platform may include a three piece MC clamp. The MC clamp includes an internal sized glans protection tube, a small external sized clamp to engage with the protection tube, and

large external procedure platform to engage with the small external sized clamp. According to various exemplary embodiments, the three pieces may be used in a necrosing or temporary style clamp and may be in a vertical or horizontal clamp direction. The pieces may be sized for a full range of infants, adolescents, and/or adults. The protection tube may have a surface coated or treated to engage with and retain foreskin. The protection tube may be tapered to engage with and retain the foreskin. The small external sized clamp may be continuously adjustable (e.g., similar to a zip tie or cable tie).

[0039] According to an exemplary embodiment, the rotational cutter may include a cutting device for making circular cuts at variable diameters when rotated. The cutting may be performed by a straight blade or straight blades on pivots, by a set of straight blades arranged in an iris configuration, by a rotating blade or blades, by a thin wire (garrote), by a heated wire, by a laser, etc. The cutting area may be smooth or may include barbs. One end of the cutter may be fixed and one end moving as rotated. One end of the cutter may move clockwise and one end move counterclockwise as rotated. The cutting diameter may be set by a manual adjustment on the cutter (e.g., by a screw, lever, switch, etc.). The cutting diameter may alternatively be automatically set by loading the blades (e.g., by a spring, lever, etc.) to close down until resisted. A cutting force may be set or modified by a manual adjustment on the cutter (e.g., crew, lever, switch, etc.).

[0040] According to an exemplary embodiment, the safety blade may include a cutting device where the blade element is not exposed until a safety blade housing is engaged with an interlock. The safety blade may be a component in the rotational cutter (with a similar cutting method) and the engaging interlock may be in the procedure platform. Disengaging the interlock may prevent reuse of the safety blade after returning it to the not exposed position.

[0041] According to an exemplary embodiment, the circumcision device may be configured so that one circumcision kit may be used to perform an MC using a sized device including all possible sized elements, for example a full-market MC device

including infant, adolescent and adult sizes or including only adult sizes. The sized devices maybe either disposable or durable (reusable) devices.

[0042] According to an exemplary embodiment, the circumcision device may include a guided closure including features integrated into an MC clamp to facilitate wound closure. The winding may be closed by a set of individual sutures (e.g., dissolvable, conventional, etc.), a running suture (with or without individual sutures at the start or end point), surgical staples, surgical glue, etc. The features may be needle guides for suturing. The use of a guide may require a custom suture needle. The features may prevent the spreading of or may absorb excess surgical glue.

[0043] According to an exemplary embodiment, the circumcision device may include interchangeable parts including a durable clamp similar to the Gomco® design where the four pieces (base plate, bell, pivot, and nut) are interchangeable. The base plate and/or bell may be interchangeable with other components of a similar size. The pivot and/or nut may be interchangeable with other components of any size.

[0044] Referring to FIGS. 1-3, a circumcision device 10 may be a horizontal necrosing clamp according to an exemplary embodiment. The circumcision device includes a protection tube 20, an inner clamp 30, an exterior clamping device 40 that is generally concentric with the inner clamp 30, and a cutting device 50.

[0045] The protection tube or sleeve 20 is a hollow member that is disposed between the foreskin 14 and the glans 12. The tube 20 is configured to shield the glans 12 from cuts or other trauma and is therefore formed from a material such as a polymer that is resistant to being cut by the cutting device 50. The protection tube 20 includes a main portion 22 and a clamping ring 24 (e.g., clamp ring, clamping band, etc.) coupled to the base of the protection tube 20. As shown best in FIG. 2, the main portion 22 may have a tapering sidewall for a better fit and for increased comfort for the patient. A variety of different size protection tubes 20 may be provided to fit a complete range of patient sizes, from infant to adult. The main portion 22 has a generally smooth outer surface and provides a cutting surface for the cutting device 50. The clamping ring 24 provides a rigid body below the foreskin 14 around which

the inner clamp 30 is fastened, trapping the foreskin between the inner clamp 30 and the clamp ring 24.

[0046] After the procedure, the main portion 22 is configured to be removed while the clamp ring 24 remains on the patient during the necrosing period. To facilitate this separation, the main portion 22 and the clamp ring 24 may be formed as separate bodies and be removably coupled together, such as with a threaded connection or bayonet connection. According to other exemplary embodiments, the main portion 22 and the clamp ring 24 may be joined by a frangible weakened portion 28 (see FIG. 12). Such a weakened region 28 may be formed, for example, by scoring the protection tube 20 to locally reduce the thickness. The main portion 22 may be twisted relative to the clamp ring 24 to break the protection tube 20 at the weakened portion 28.

[0047] According to one exemplary embodiment, a single body may comprise a number of differently sized main portions 22 and clamping rings 24. Each of the main portion 22/clamping ring 24 pairs may coupled together with weakened portions 28. The protection tube 20 may be separated at these weakened portions 28 to break off the correct size main portion 22 and clamping ring 24 for each patient. The circumcision device 10 may include three clamping or glans protection tubes of different sizes (e.g., 17 mm, 25 mm, 32 mm, etc.). According to other exemplary embodiments, more or fewer than three tube sizes may be used.

[0048] A clamp is placed over the foreskin 14 and traps the foreskin against the clamp ring 24. According to an exemplary embodiment, the clamp includes a smaller inner clamp 30, and a larger exterior clamping device or outer clamp 40 that fits over the inner clamp 30. The exterior clamping device 40 provides a body allowing for easy handling of the circumcision device 10. As the larger exterior clamping device 40 is closed it tightens and locks the inner clamp 30. According to one exemplary embodiment, the exterior clamping device 40 and the inner clamp 30 may be formed as an integral device. According to other exemplary embodiments, the inner clamp 30

may be a separate body, as shown in FIG. 3 A. The inner clamp 30 may be continuously adjustable (e.g., similar to a zip tie or cable tie).

[0049] According to one exemplary embodiment, the inner clamp 30 may be a lockable nylon clamp configured to interlock with the exterior clamping device 40. The circumcision device 10 may include various size clamps 30 to fit the diameters required (e.g., one size, two sizes, three sizes, etc.).

[0050] The cutting device 50 is coupled to the exterior clamping device 40 and if configured to be rotated around the exterior clamping device 40 to cut the foreskin 14 above the exterior clamping device 40. According to one exemplary embodiment, the cutting device 50 comprises a holder 52 that is mounted to the external clamping device 40 and a blade or scalpel 54 that is coupled to the holder 52 and moveable from a first position in which it is not touching the foreskin 14 (e.g., an unexposed position, retracted in the holder 52) and a second position in which it can cut the foreskin 14 (see FIG. 1). The first position is indicated in FIG. 1 with dashed lines. As shown in FIG. 4, the blade 54 may be pivoted with a lever 56 to move it from the first position to the second position. The pivoting blade 54 is able to perform a procedure on a number of different sized patients, from a minimum diameter 57 to a maximum diameter 59. As the lever 56 is pressed forward, the blade 54 advances, cutting the foreskin 14, and stops when the blade 54 engages the glans protection tube 20. Sizes can be marked on the circular cutter to indicate the travel of the lever 56. According to one exemplary embodiment, the blade 54 is spring loaded and returns to the first position after cutting. A breakaway tab or similar part may be removed when the cutting device 50 interlocks with the external clamping device 40 in order to prevent reuse (e.g., an auto-destruct feature).

[0051] According to an exemplary method, the clinician or staff locates the correct size glans protection tube 20 and fits the foreskin 14 over the protection tube 20 such that the protection tube 20 is disposed over the glans 12. The clinician secures the internal clamp 30 around the foreskin 14 and tube 20 (e.g., proximate to the clamp ring 24). The external clamping device 40 is added over the internal clamp 30 and the

scalpel holder 52 is snapped on to the external clamp 40. The scalpel blade 54 is pivoted to a correct setting for the protection tube 20 size and the clinician performs the cutting operation. The blade 54 is sheathed (e.g., retracted into the holder 52) and holder 52, the external clamping device 40, and the main portion 22 of the protection tube 20 are removed. The clamping ring portion 24 of the tube 20 and the internal clamp 30 remain on the patient for later removal.

[0052] After the procedure is complete the larger outer clamp 40 is removed leaving the smaller inner clamp 30 on the patient until the skin dies and falls off. The circumcision device 10 is configured to leave the patient with a relatively small clamping band 24 and inner clamp 30.

[0053] Referring to FIG. 5-7, according to another exemplary embodiment, the circumcision device 110 may be a horizontal necrosing clamp including a garrote (wire) cutter 150. Similar to the previously described device, the circumcision device 110 includes a protection tube 120, an inner clamp 130, an exterior clamping device 140 that is generally concentric with the inner clamp 130, and a cutting device 150.

[0054] The cutting device 150, as shown best in FIG. 7, is a garrote cutter that is configured to vary the depth of the cut depending on the protection tube 120 used while leaving only a small clamping band 124 after the procedure. The garrote cutter 150 comprises a length of wire 154 (e.g., a cutter) with a first end 153 that is held stationary by the external clamping device 140 and a second end 155 that is coupled to a lever 156 or other device moveable by the operator. The wire 154 initially is slack and forms a diameter larger than the diameter of the glans 12 and foreskin 14. When the lever 156 is engaged it draws the second end 155 of the cutter 154 about the periphery of the external clamping device 140, tightening the garrote 150 and reducing the diameter formed by the wire cutter 154. As the garrote 150 is tightened, it cuts the foreskin 14. The garrote cutter 150 allows the circumcision device 110 to have a relatively compact profile. Tension of the garrote cutter 150 can be controlled to enhance performance and control the depth of the cut.

[0055] As shown best in FIG. 6, the exterior clamping device 140 may extend outward to form a procedure platform for the circumcision device 110. The exterior clamping device 140 facilitates the installation and positioning of the inner clamp 130.

[0056] During the procedure, a protective sleeve may be provided that is formed from a resilient material such as silicone. The protective sleeve is stretched over the foreskin 14 and attached to the circumcision device 110. The sleeve is positioned such that it tensions the foreskin 14 away from the clamp so when the foreskin 14 is cut, the detached portion will separate from the portion retained by the clamping ring 124 and the inner clamp 130. The additional separation provides the operator with visual feedback that the cut was successful and glans protection tube 120 and the foreskin 14 can now be removed. The silicone sleeve also adds additional safety protection by covering the area during cutting.

[0057] Referring now to FIG. 8, according to one exemplary embodiment, the inner clamp 130 may include a lasso-type clamping mechanism. The inner clamp 130 includes a flexible member 132 (e.g. band, belt, cord, cable, etc.) and a locking mechanism 134 (e.g., locking block, locking member). A first end of the flexible member 132 is anchored to the locking member 134. The flexible member 132 is then looped twice around the foreskin 14 and the protection tube 120. The second, free end of the flexible member 132 passes through the locking member 134. The locking member 134 is configured such that the flexible member 132 may only travel through the locking member 134 in one direction. The operator therefore passes the second end of the flexible member 132 through the locking member 134 and pulls to tighten and lock the inner clamp 130. The lasso clamp is configured to control tension and placement of the flexible member 132 and automatically secure the flexible member 132 while leaving the patient with a smaller clamping ring 124.

[0058] As shown in FIG. 9, the clamping ring 124 may include a peripheral groove or indentation 126 that is configured to receive a flexible member 132 such as a cord for a lasso-type inner clamp 130.

[0059] Referring now to FIG. 10, according to another exemplary embodiment, the cutting device for a circumcision device 110 may be an iris cutter 250 that comprises a plurality of knives or blades 254 that emerge from the exterior clamping device 140 similar to the shutter of a camera iris. When the exterior clamping device 140 (e.g. rotated in a clockwise direction, as indicated in FIG. 10), the blades 254 advance, contacting and cutting the foreskin 14. The advance of the blades 254 is stopped by the glans protection tube 120. According to one exemplary embodiment, the blades 254 are prevented from advancing until the external clamping device 140 is engaged with the inner clamp 130. After the blades 254 have advances and contacted the foreskin 14, the circumcision device 110 is rotated a short distance to ensure more complete cutting of the foreskin 14. The circumcision device is spring loaded and the blades 254 return and lock into place within the exterior clamping device 140 after cutting (e.g., so the circumcision device is intended for a one time use). The circumcision device 110 and the foreskin 14 can then be removed.

[0060] Referring now to FIG. 11, according to another exemplary embodiment, the cutting device for the circumcision device 110 may be a cutting device 350 comprising one or more roller cutting wheels 354. The roller cutting wheel (or circular cutting blade) 354 is mounted to a pivoting arm 352. When the exterior clamping device 140 (e.g. rotated in a clockwise direction, as indicated in FIG. 11), the blades 354 are advanced by the pivoting arms 352, contacting and cutting the foreskin 14. The advance of the blades 354 is stopped by the glans protection tube 120. According to one exemplary embodiment, the blades 354 are prevented from advancing until the external clamping device 140 is engaged with the inner clamp 130. After the blades 354 have advances and contacted the foreskin 14, the circumcision device 110 is rotated a short distance to ensure more complete cutting of the foreskin 14. The circumcision device is spring loaded and the blades 354 return and lock into place within the exterior clamping device 140 after cutting (e.g., so the circumcision device is intended for a one time use). The circumcision device 110 and the foreskin 14 can then be removed. According to one exemplary embodiment, a three wheel arrangement may be used, with each blade engaging and cutting a 120 degree path, as illustrated in FIG. 11. According to another exemplary embodiment,

the circumcision device 110 may only include a single circular cutting blade 354 that engages and cuts a 360 degree path. According to still other exemplary embodiments, any number of circular cutting blades 354 may be provided.

[0061] Referring now to FIGS. 13-14, according to other exemplary embodiments, a circumcision device 410 may include a durable (e.g., reusable) temporary clamp 430 and a glans protection tube 420 with a guided closure system. Similar to the tubes described above, the glans protection tube 420 includes a main portion 422 and a clamp ring 424. However, the clamp ring 424 is not configured to remain on the patient after the procedure. Instead, sutures 18, surgical glue, or other known methods are used to close the skin during the procedure, after which, the clamp ring 424 is removed. To facilitate the suturing of the skin, the protection tube 420 comprises a multitude of needle guide slots 426 (e.g., grooves, contours, depressions, etc.) about the base of the main portion 422, proximate to the clamp ring 424. The slots 426 are configured to guide the needle 16 used by the clinician to facilitate consistent, good quality sutures. According to one exemplary embodiment, the needle guide slots 426 are provided on the protection tube 420. According to other exemplary embodiments, guide slots may also be included in the side of the clamp 430 to further assist the clinician.

[0062] In practice, the glans protection tube 420 is inserted over the glans and the foreskin 14 is pulled forward and positioned over the protection tube 420. The reusable clamp 430 is placed over the foreskin 14 and the protection tube 420 and is temporarily tightened down. The foreskin 14 is then cut using a conventional disposable scalpel, a garrote cutter similar to the cutter described above, or any other suitable cutting device. A guide may be provided on the protection tube 420 to ensure a more consistent cut for a conventional scalpel. The foreskin 14 is then removed from protection tube 420 and the clinician sutures (e.g., with a whip stitch) the skin with the help of needle guide slots 426. Once the suturing is completed the clamp 430 is slowly released to verify no bleeding and the clamp 430 is then completely removed.

[0063] Referring now to FIGS. 15A- 16, according to other exemplary embodiments, a circumcision device 510 may include a disposable clamp temporary clamp 530 (e.g., similar to the inner clamp described above) and a glans protection tube 520 with a guided closure system. Similar to the tubes described above, the glans protection tube 520 includes a main portion 522 and a clamp ring 524. However, the clamp ring 524 is not configured to remain on the patient after the procedure. Instead, sutures 18, surgical glue, or other known methods are used to close the skin during the procedure, after which, the clamp ring 524 is removed. To facilitate the suturing of the skin, the protection tube 520 comprises a multitude of needle guide slots 526 (e.g., grooves, contours, depressions, etc.) about the base of the main portion 522, proximate to the clamp ring 524. The slots 526 are configured to guide the needle 16 used by the operator to facilitate consistent, good quality sutures. According to one exemplary embodiment, the needle guide slots 526 are provided on the protection tube 520. According to other exemplary embodiments, guide slots may also be included in the side of the clamp to further assist the clinician.

[0064] In practice, the glans protection tube 520 is inserted over the glans and the foreskin 14 is pulled forward and positioned over the protection tube 520. A one-time use disposable clamp is placed over the foreskin 14 and the protection tube 520 and is temporarily tightened down. The foreskin 14 is then cut using a conventional disposable scalpel, a garrote cutter similar to the cutter described above, or any other suitable cutting device. A guide may be provided on the protection tube 520 to ensure a more consistent cut. The foreskin 14 is then removed from protection tube 520 and the clinician sutures (e.g., with a whip stitch) the skin with the help of needle guide slots 526. Once the suturing is completed the clamp 530 is slowly released to verify no bleeding and the clamp 530 is then completely removed.

[0065] The main portion 522 and the clamping ring 544 may separate and can be two pieces that interlock with a twist and lock method. The circumcision device may include three clamping or glans protection tubes of different sizes (e.g., 17 mm, 25 mm, 32 mm, etc.). According to other exemplary embodiments, more or fewer than three tube sizes may be used.

[0066] It is important to note that the construction and arrangement of the circumcision device as shown in the various exemplary embodiments is illustrative only. Although only a few embodiments have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter disclosure herein. For example, elements shown as integrally formed may be constructed of multiple parts or elements, the position of elements may be reversed or otherwise varied, and the nature or number of discrete elements or positions may be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present application. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes and omissions may be made in the design, operating conditions and arrangement of the exemplary embodiments.