The protective circumcision device

Abstract

The protective circumcision device consists of three members that co-function together to perform circumcision: the protective tube (A), the clamping cage (B), and the traction nut cap (C).The protective tube (A), which is a hollow tube with two opened ends (1) and (2); the proximal end has a conical shape (6) and has a circumferential marginal flange (9).The distal part of the protective tube (3) has a circumferential threaded external surface (3'').the clamping cage (B) of the invention, which includes two circular plates (13) and (14) connected by two or three arms (17).The proximal circular plate (14) is angled in comparison to the distal circular plate (13).The traction nut cap has inside threads (24) and holes (25) in half of its width. Each hole has a facing hole and is located on a plane that represents the diameter of the nut circle.

Description

[0001] The Protective Circumcision Device

[0002] Technical Field:

[0003] This invention relates to a set of disposable surgical tools for circumcision.

[0004] Background Art:

[0005] Male circumcision is one of the oldest known surgical procedures. The procedure is carried out for a variety of reasons, including its traditional, cultural, or religious importance.

[0006] The word circumcision comes from the Latin "circumcidere" which means to cut around.

[0007] It entails partial or complete excision of the foreskin of the male penis.

[0008] The foreskin is a continuation of skin from the shaft of the penis, forming a fold that covers the glans penis and the urethral meatus.

[0009] Since the foreskin is a fold, the inner foreskin and the outer foreskin are continuous with each other and also freely mobile with respect to each other.

[0010] It is possible to remove unequal amounts of the two layers of foreskin. Understanding this is crucial to understanding of circumcision styles.

[0011] The foreskin is attached to the glans by the frenulum, which acts like a bridge between the glans and the inner skin of the foreskin fold. The frenulum is highly vascular and carries some of the blood supply to the glans.

[0012] The inner foreskin and glans require regular cleaning to ensure adequate penile hygiene, as they contain glands that secrete an oily substance called smegma. There is a potential for these secretions to accumulate between the inner foreskin and glans, forming a potential environment for proliferation of naturally found bacteria on the skin, resulting in a bad smell.

[0013] Difficulties in maintaining good penile hygiene may contribute to the risk of infection among uncircumcised men.

[0014] WHO published a paper concluding that male circumcision protects men from acquiring HIV.

[0015] Another paper concluded that circumcision would have a favorable cost-benefit ratio for boys at high risk of urinary tract infections. History:

[0016] Circumcision is the most common surgical procedure, and it involves the use of many instruments.

[0017] One of these instruments is described in US patent number 9,445,835B2 by Milad et al. The device has a proximal end, a distal end, an inner recess, and an outer surface. The inner recess opens from the proximal end and is designed to receive the glans of a penis. During use, the foreskin is pulled over the outer surface until it reaches a predetermined indicator, which provides a visual guide to the level of circumcision.

[0018] One of the device’s limitations is that it requires the frenulum to be cut as a preliminary step before the circumcision procedure. Another disadvantage of this device is that it necessitates two personnel to perform the circumcision procedure: one to pull the prepuce skin and the other to counteract by pushing the device. This device has another shortcoming in that it does not respect the normal inclination of the glans over the shaft.

[0019] In US Patent No. 3,072,126, P. M. Fenton describes a circumcision device that uses the circular edge of the bell-shaped member to cut and promote hemostasis. The device’s bellshaped member is painted with a pressure-sensitive and heat-resistant adhesive to withstand high temperatures and pressure from repeated sterilization. However, the device has some limitations: it is reusable and does not respect the normal anatomical inclination of the glans of the penis on the shafts. Additionally, premature cutting may occur before adequate compression of the skin of the prepuce, resulting in bleeding.

[0020] US Patent No. 119,180 by Goldstein et al. describes another circumcision clamp that consists of a plate, a metallic bell, an arm, and a nut. The compression of the prepuce is achieved by applying pressure between the bell and plate. The pressure is sustained for a while to achieve hemostasis before excision. This clamp has some shortcomings. One of them is that the bell is separate from the clamp, which makes it possible to use the wrong size bell with the wrong size clamp. Another shortcoming is that if the crushing action of the clamp is released prematurely, bleeding will occur, and suturing will be needed. This makes the device unsuitable for anyone with a bleeding tendency. Additionally, the crushing plane is perpendicular to the shaft of the penis and not angled to match the natural anatomical slant of the corona of the penis. International Patent Application No. WO 2011 / 007358 A2 describes a circumcision device that includes an inner ring with a circumferential groove, at least one capturing ring, and a hollow cylinder. First, the inner ring is fitted on the posterior end of the hollow cylinder, and the assembled inner ring, together with the hollow cylinder, is slid under the foreskin over the glans. The capturing ring is then placed over the foreskin, tightly fitting into the circumferential groove of the inner ring, thereby compressing the foreskin along the circumferential groove and restricting blood supply to the foreskin at the compressed site. The hollow cylinder is then removed, leaving the inner ring and the capturing ring on the penis. One of the drawbacks of this device is that misjudgment of the correct placement of the inner ring can cause either insufficient or excessive removal of the foreskin. Furthermore, this circumcision device does not have a feature that allows for holding and extending the foreskin during the circumcision procedure. It is almost impossible to keep the retractable foreskin in a static position to enable the correct placement of the capturing ring on the circumcision line. Another shortcoming is device displacement, which occurs when the device slips off the foreskin due to erection, manipulation, or improper placement. This can cause incomplete circumcision or the application of compression in the wrong place (as in the glans) and may require surgical completion.

[0021] Disclosure of the protective circumcision device: -

[0022] The objective of the invention is to provide an easy-to-use and reliable tool that produces a clean circumcision. The tool is designed to be easy to practice with, and it is intended to make the process of circumcision more accessible and less intimidating for both patients and practitioners.

[0023] - Another objective of the invention is to enable the performance of circumcision with visual protection of the glans penis.

[0024] - Another objective of the present invention is to apply clamping pressure on a desired circumferential area of the prepuce, allowing for a good bloodless circumcision.

[0025] - Another objective of the present invention is to provide a clean wound at the circumcised site without the need for dressing to be applied to it.

[0026] - Another objective of the present invention is to provide a simple, easy, and fast-to-Learn tool for performers, making it suitable for rural and remote areas with a deficiency of trained personnel. Another objective of the invention is to provide an innovative instrument that preserves and retains the frenulum, which is the bleeding point during a circumcision operation.

[0027] - The invention provides another object with an angled clamping part that helps the performer to anatomically align the Circumcision scar with the shaft of the penis, taking into account the anatomical position of the glans with a mild inclination on the shafts of the penis.

[0028] - Another objective of the present invention is to keep the cut ends of the circumcised Skin opposed together over the inner part of the device and stay in this Condition until healing with lesser Chance of formation of constriction ring to the glans after removal of the device.

[0029] - Another objective of the device that it is made of plastic or similar materials, which are cost- effective to produce. It is sterilized and packaged in sterile packaging for single-use and disposal purposes.

[0030] Detailed description of the invention regarding figures:

[0031] The protective circumcision device consists of three members that co-function together to perform circumcision: the protective tube (A), the clamping cage (B), and the traction nut cap (C), as shown in FIG. 1 in pre-engagement status.

[0032] As referred to in FIG. 2, the protective tube (A), which is a hollow tube with two opened ends (1) and (2); the proximal end has a conical shape (6) concerning the fact that the anterior side length is shorter than the posterior side length.

[0033] The proximal part of the protective tube (6) has a circumferential marginal flange (9) that appears in the side view as a circumferential angled flange.

[0034] The body of the protective angled tube (5) has at least two circumferential constrictions (5") on the surface of the tube.

[0035] The distal part of the protective tube (3) has a circumferential threaded external surface (3").

[0036] The distal threaded part (3) has a longitudinal cut (7) at the diameter of the tube, which is limited to the distal part and does not extend to the body (5) and divides the distal part into two equal parts.

[0037] At the junction of the body of the protective tube (5) and the distal threaded part (3), there is a circumferential flange (8) with a small projection (4) at the posterior circumference of this flange. As shown in Figures 3 and 4, the proximal conical-angled part (6) of the protective tube has a small downward extension from the body of the tube at the anterior sector of the circumference (10) below the circumference marginal flange (9).

[0038] The downward extension (10) smoothly decreases in length beyond the flange until it disappears. It is limited to the anterior half sector of the proximal end circumference and has a groove with a curved apex (11) located at the center,

[0039] As referred to in Figures 5, 6, and 14, the protective angled tube has four inside projections (12) at the junction of the proximal conical part (6) and the body of the tube (5), which are connected to form a central circle to prevent proximal migration of the device.

[0040] As referred to in Figures 7 and 8, it shows the clamping cage (B) of the invention, which includes two circular plates (13) and (14) connected by two or three arms (17).

[0041] The two circular plates have two center openings, the distal opening (15) and the proximal opening (16).

[0042] The anterior connecting arm is shorter than the posterior arms.

[0043] The proximal circular plate (14) is angled in comparison to the distal circular plate (13).

[0044] The connecting arms have at least two constrictions (18).

[0045] The distance between the two circular plates at the front (anterior) half of the clamping cage is equal to the distance between the two flanges at the front (anterior) half of the protective tube.

[0046] The distance between the two circular plates at the back (posterior) half of the clamping cage is equal to the distance between the two flanges on the back (posterior half) of the protective tube.

[0047] The diameter of the opening at the center of the proximal circular plate (16) of the clamping cage is greater than the diameter of the conical part (6) of the protective tube but less than the diameter of the external circumferential flange (9).

[0048] The distal circular plate has a recess or notch (20) that faces the inside of the circular plate at the back (posterior) half of the circumference of the plate.

[0049] The anterior connecting arm is located in the center of the front (anterior) half of the clamping cage. There is a small indicator (19) of the anterior direction of the device located at the center of the anterior half circumference of the distal circular plate, in line with the anterior connecting arm.

[0050] As shown in FIG. 10, 11, and 12, it shows the traction nut cap (C) that is circular and open on two sides (22) and (23).

[0051] The traction nut cap has inside threads (24) and holes (25) in half of its width. Each hole has a facing hole and is located on a plane that represents the diameter of the nut circle.

[0052] As shown in FIG. 15, 16, and 17, it shows the three members of the invention in engagement status, with the locker rod (26) being fired into the coupled holes (25) in the traction nut cap (C) and through the cut (7) in the protective tube (A).

[0053] As shown in FIG. 18, there is a measuring guide with different diameter according to external circumference of penis at coronal sulcus.

[0054] As shown in Figure 19, there is a tying aid, which is a half-circular rod with a small hole at the end of one side. The thread can be attached through the hole and used to tie a ligature at the constriction around the stretched prepuce over the protective angled tube.

[0055] Summary Steps of Circumcision Using the Protective Circumcision Device:

[0056] Detection of the exact size of the used device by passing the uncircumcised penis head up to the coronal sulus through the holes of the measuring guide (FIG.18).

[0057] Open the sterile package of the device and make sure that the chosen size of the device is the same as the size of the selected measuring guide.

[0058] After cleaning the penis with removal of any smegma found and application of local anesthetic medication, dilatation of prepuce opening.

[0059] Repositioning the protective curved tube by putting the longest part of the tube on the back side and the shortest one on the front side, as well as the projection at the distal flange (4), is an indicator of the back side.

[0060] Retraction of the prepuce and insertion of the proximal conical angled part (6) to cover the glans through the opening of the proximal conical part (2) of the protective tube, with passage of the frenulum through the groove (11) in the tube. Positioning of the tube until the coronal sulcus, then stretching of the prepuce on the external surface of the protective tube.

[0061] - Hold the stretched prepuce in its position by many options:

[0062] -Tie a silk knot through the tying aid (27) on the stretched prepuce over the protractive tube at one of the constrictions (5") on the tube.

[0063] - By holding the stretched prepuce by the operator's hand.

[0064] By partial engagement of the second member of the device.

[0065] Inserting the clamping cage (B) gradually onto the protective curved tube (A) through the opening (16) of the proximal circular plate (14) with respect to the position indicated by the indicator (19) of the front side on the distal circular plate (13) until the projection (4) on the distal circumferential flange (8) of the protective tube engages into the notch (20) on the inside of the distal circular plate (13) of the clamping cage. This engagement prevents the rotational movement of the two parts.

[0066] Engagement of the traction nut cap (C) onto the external threaded part (3) of the protective tube.

[0067] Tight engagement of the cap will provide upward movement of the protective tube, which results in constricting the prepuce between the proximal circumferential flange (9) of the protective tube and the proximal circular plate (14) of the clamping cage.

[0068] Excision of the stretched prepuce over the tube in between the connecting arms.

[0069] Firing of the traction nut cap hole (25) by passing a locker rod (26) through one of the holes facing the cut (7) in the distal threaded part and passing it to the other coupled hole.

[0070] The device will fall by itself in about 7-10 days.

[0071] If it does not fall spontaneously or there are any circumstances that require the removal of the device, the reverse steps will be followed in the following order:

[0072] - Removal of the locker rod.

[0073] - Disengagement of the traction nut cap by anti-clock rotation.

[0074] - Then pull out the clamping cage with the release of the protective tube through the proximal and distal openings of the cage. - Then gradual detachment of the protective tube.

[0075] Brief descriptions of the drawings

[0076] FIG. 1 is a prospective three-dimensional side view of the three members of the invention.

[0077] FIG. 2 represents a three-dimensional side view of the protective tube (A).

[0078] FIG. 3 represents another three-dimensional side view of the protective tube (A).

[0079] FIG. 4 is a side view of the protective tube (A).

[0080] Fig. 5 represents the top view of the protective tube (A).

[0081] FIG. 6 represents a cross-sectional view of the protective tube at plane A-A shown in Fig.5.

[0082] FIG. 7 is a prospective three-dimensional side view of the clamping cage member (B) of the invention.

[0083] FIG. 8 is a side view of the clamping cage member (B) of the invention.

[0084] FIG. 9 is a top view of the clamping cage member (B) of the invention.

[0085] FIG. 10 is a prospective three-dimensional side view of the traction nut cap (C) of the invention.

[0086] FIG. 11 is a top view of the traction nut cap (C) of the invention.

[0087] FIG. 12 represents a cross-sectional view of the traction nut cap (C) at plane X-X shown in Fig. U.

[0088] FIG. 13 is a prospective three-dimensional side view of the three members of the invention in pre-engagement status.

[0089] FIG. 14 represents a three-dimensional oblique view of the three members of the invention in pre-cngagement status, as shown in FIG. 13.

[0090] Fig. 15 represents a three-dimensional side view of the three members of the invention in locked status.

[0091] FIG. 16 represents a three-dimensional oblique top view of the three members of the invention in locked status.

[0092] FIG. 17 represents a three-dimensional side view of the three members of the invention before firing the locker into the holes of the traction nut cap of the invention. FIG. 18 represents a measurement guide.

[0093] FIG. 19 represents a tying aid.

Claims

AMENDED CLAIMS received by the International Bureau on 20 March 2024 (20.03.2024)1. (amended) a protective circumcision device, wherein said device includes a protective angled tube, a clamping cage, a traction nut cap, and a locker rod, wherein the protective angled tube, the clamping cage, the traction nut cap, and the locker rod work together to perform safe circumcision of people with unknow bleeding disorders, wherein more preferred for circumcision of people with known bleeding disorders after preparations.

2. (new) a protective circumcision device of claim 1, wherein the protective circumcision device is preferred for people with bleeding disorders, wherein bleeding disorders includes hemophilia, von Willebrand disease, and coagulation factors deficiency, lichen sclerosus.2.3 (amended)The protective circumcision device of claim 1, wherein the protective angled tube has two open ends, a proximal conical part, a body, and a distal threaded part.2.

4. (canceled) the protective circumcision device of claim 2, wherein the proximal conical part of the protective angled tube has a circumferential marginal flange.4.5 (canceled) the protective circumcision device of claim 2, wherein the proximal conical part has a small downward extension from the body of the protective angled tube at an anterior sector of the circumference below the circumferential marginal flange, wherein the downward extension smoothly decreases in length beyond the circumferential marginal flange until the downward extension disappears, wherein the downward extension is limited to an anterior half of a proximal end circumference.5.6 (amended) the protective circumcision device of claim 2 (new number 3), wherein the proximal conical part of the protective angled tube has a circumferential marginal flange, wherein the protective angled tube has a downward extension from body of a protective angled tube at an anterior sector of a circumference below the circumferential marginal flange, wherein the downwardextension is preferred 5 mm from body of protective angled tube , wherein the downward extension is more preferred 6 mm from body of protective angled tube, wherein the downward extension has a groove with a curved apex located at a center, wherein a groove depth is equal to length of a downward extension.6.7 (amended) the protective circumcision device of claim 2(new number 3), wherein the protective angled tube has four inside projections at a junction of the proximal conical part and the body of the protective angled tube, wherein the four inside projections are connected to form a central circle.7.8 (amended) the protective circumcision device of claim 2(new number 3), wherein the body has at least two circumferential constrictions on a surface of the protective angled tube.5.9 (canceled) the protective circumcision device of claim 2, wherein the distal part of the protective angled tube has a circumferential threaded external surface.9.10 (amended)the protective circumcision device of claim 2(new number 3), wherein the distal part of the protective angled tube has a circumferential threaded external surface, wherein the distal threaded part has a longitudinal cut at a diameter of the protective angled tube, wherein the longitudinal cut is limited to the distal threaded part and does not extend to the body of the protective angled tube and divides the distal threaded part into two equal parts.4-9.11 (amended) the protective circumcision device of claim 2(new number 3), wherein at a junction of the body of the protective angled tube and the distal threaded part, there is a circumferential flange with a small projection with wide base at a posterior circumference of the circumferential flange, wherein a length of a small projection is equal to thickness of circumferential flange.4-4-.12 (amended) the protective circumcision device of claim 2(new number 3), wherein a length between a circumferential marginal flange at a junction of body of the protective angled tube with distal threaded part and the circumferential marginal flange at a proximal conical part is shorter on an anterior part of a protective angled tube than a posterior side length, wherein the circumferential marginal flange is an angled flange and a protective angled tube is created.4-2.13 (amended) the protective circumcision device of claim 1, wherein the clamping cage comprises two circular plates with a distal opening and a proximal opening, wherein the clamping cage is connected by two or three arms, wherein an anterior connecting arm is shorter than posterior arms, wherein a proximal circular plate is angled with respect to a distal circular plate, wherein the anterior connecting arm is located in a center of an anterior half of the clamping cage, wherein an anterior connecting arm is an indicator of tightness of engagement status of the protective circumcision device.4-3-.14 (canceled) the protective circumcision device of claim 12, wherein an anterior connecting arm is shorter than posterior arms, wherein a proximal circular plate is angled with respect to a distal circular plate.4-4.15 (canceled) the protective circumcision device of claim 13, wherein the anterior connecting arm is located in a center of an anterior half of the clamping cage.4-5.16 (canceled) the protective circumcision device of claim 13, wherein the clamping cage includes a small indicator of an anterior direction of the protective circumcision device located at a center of an anterior half circumference of the distal circular plate, in line with the anterior connecting arm.46.17 (amended) the protective circumcision device of claims (new 11 and 13), wherein the distal circular plate has a recess or notch that faces an inside of the distal circular plate at a posterior half of a circumference of the distal circular plate, wherein a length of a notch is equal to length of a projection on circumferential flange of a protective angled tube.4-7.18 (canceled) The protective circumcision device of claim 1 , wherein a distance between two circular plates at an anterior half of the clamping cage is equal to a distance between two flanges at an anterior half of the protecting angled tube.4-8.19 (canceled) The protective circumcision device of claim 1 , wherein a distance between two circular plates at a posterior half of the clamping cage isequal to a distance between two flanges on a posterior half of the protecting angled tube.4-9.20 (canceled) The protective circumcision device of claim 1 , wherein a diameter of an opening at a center of a proximal circular plate of the clamping cage is greater than a diameter of a conical part of the protecting angled tube but less than a diameter of an external circumferential flange.20.21 (original)the protective circumcision device of claim 1, wherein the traction nut cap is circular, open on two sides, and includes internal threads and holes.24-.22 (original) The protective circumcision device of claim 21, wherein the holes are located at half of a width of the traction nut cap, wherein each hole has a facing hole located on a circumference of a traction nut cap, wherein every two facing holes represent a diameter of the traction nut cap.22.23 (amended)The protective circumcision device of claim 1 includes a locker rod, wherein the locker rod is a plastic rod has a blunt end and a head, wherein the head is wider than a hole of a traction nut cap, wherein the diameter of the locker rod is suitable to pass through holes of the traction nut cap and a cut in the protective angled tube to lock the protective tube, the clamping cage, and the traction nut cap of the protective circumcision device during engagement status.

24. (new) the protective circumcision device of claim 23, wherein the locker rod is used as a separator of glans penis from attached prepuce if present.

25. (new) the protective circumcision device of claims 1, 13, and 21, wherein the distal surface of traction nut cap has green, yellow, and red sectors scale, wherein sector represents 15 - 20 of circumference of the traction nut cap, wherein green sector represents a safe engagement status of the protective circumcision device, wherein a safe engagement status represents tight engagement of the protective circumcision device, wherein yellow sector signifies an acceptable engagement status of the protective circumcision device, wherein an acceptable engagement status represents potentially tight engagement of the protective circumcision device, wherein red sector signifies a dangerous engagement status of the protective circumcision device, wherein dangerous engagement status representsloose engagement of the protective circumcision device, wherein green, yellow, and red sector scale aligns with the anterior arm of the clamping cage.23.26 (amended)The protective circumcision device of claim 1 and 3, wherein when the protective circumcision device is in an engaged status, a constriction on a body of the protective angled tube faces a constriction on arms of the clamping cage, making it easy to detect the constrictions and tie a ligature on the constrictions if needed to hold a prepuce in place.24.27 (canceled) The protective circumcision device of claim 1 , wherein the protective circumcision device is manufactured from a lightweight material suitable for medical use and is designed to be disposable.

Images