WO2013079077A1

WO2013079077A1 - The anatomical circumcision ring

Info

Publication number: WO2013079077A1
Application number: PCT/EG2011/000026
Authority: WO
Inventors: Sherif Hamdy Abdel-Maguid ABDEL-AZIZ
Original assignee: Abdel-Aziz Sherif Hamdy Abdel-Maguid
Priority date: 2011-11-30
Filing date: 2011-11-30
Publication date: 2013-06-06

Abstract

A disposable circumcision device includes a transparent supporting tube (1), an angled ring (2), and two clamps (16,17). The tube includes at least two circumferential grooves (3) on the outer periphery; with a circular protrusion (4) around the anterior end of the tube; includes two L- shaped slit (14) which are the female part of bayonet joint. The angled ring includes two pins (8) which are the male part of the joint. The angled ring includes circumferential groove (9); parallel to the angle formed groove. The ring includes an extension (13) from the posterior end; at the shorter side (2B) of the ring. This extension includes a notch. The device includes two clamps; one is a constricting which is applied around angled groove, other is fixing one; which is applied around one of the grooves of the supporting tube.

Description

The Anatomical Circumcision Ring

Field of the invention

This invention relates to a disposable surgical devices used in performing circumcision.

Background of the invention

Male circumcision is one of the oldest surgical procedures known, traditionally undertaken as a mark of cultural identity or religious importance.

Human males receive a circumcision at some points in their lives. It may occur from the neonatal period to the early twenties.

The foreskin is a continuation of skin from the shaft of the penis that covers the glans. The foreskin is attached to the glans by the frenulum, a highly vascularized tissue of the penis. The frenulum forms the interface between the outer and inner foreskin layers.

Circumcision is removal of some, or all, of the foreskin from the penis.

The perception of improved penile hygiene is one of the main determinants of circumcision. The inner foreskin and glans require regular cleaning to ensure adequate penile hygiene.

Difficulty in maintaining good penile hygiene may contribute to the risk of infections among uncircumcised men. WHO have published papers cited research which showed that the risk for infection of HIV is lowered by 44%- 71 % in circumcised men, one possible explanation of the results of such studies is that the inner mucosal surface of the foreskin is thinly keratinized, unlike the penile shaft and the outer surface-to-air of the foreskin, and may be more susceptible to minor trauma and abrasions that facilitate entry of the pathogens. There are different circumcision styles; style preference is undertaken according to many reasons: religious, cultural and medical reasons.

Over years, there are many instruments known for performing circumcision. The most commonly used circumcision clamp is described in U.S. Pat. No.1 19, 180 by A. A. Goldstein (Referred to herein as the Gomco). It consists of a plate, a metallic bell, an arm, and a nut (screw to tighten the clamp). The bell is introduced over the glans and the prepuce is drawn over it. The plate is then placed over the bell. The arm and the nut are used to apply a force between the clamp and the bell. The clamp is left on for few minutes to achieve homeostasis before excision.

One of the shortcomings of the Gomco is that the bell is separate from the clamp making it possible to use the wrong size bell with wrong size clamp.

Another shortcoming is that the bell has a closed end. The possibility for the coronal rim of the glans to be trapped in the clamp is high.

Another shortcoming is that if the crushing action of the clamp is released prematurely, bleeding will occur and suturing is needed. This makes the device is not suitable for anyone with bleeding tendency.

Another shortcoming is that the crushing plane is perpendicular to the shaft of penis and not angulated to match the natural anatomical slant of the corona of the penis. Thus it is impossible to remove the whole inner foreskin ventrally, even if it is fully removed dorsally.

Another commonly used circumcision devices are described in U.S. Patent

No.2, 272,072 by Ross and U.S. Patent No. 3, 056,407 by Kariher et al. and U.S. Patent No.2007/0060928 A1 by Dave et al. The principle of these devices is application of cone or bell shaped device over the glans and the prepuce is drawn over it. The prepuce is tied off with a string in the form of tourniquet. The remaining foreskin is trimmed with scissors.

There are many shortcomings to these devices: First: these devices are not providing glans protection with possibility of accidental injury to the penis.

Second: it is very difficult to engage and tie the ligature, and to be sure that the ligature from the presence of blood does not slipped with subsequent application of the ligature proximally resulting in injury to the shaft of penis. Third: its usage is assistant dependant, in which it is very difficult simultaneously to hold the ring in place, keep the foreskin together, and tie a knot at the precise position on the ring.

Fourth: surgical scissors are used to cut the foreskin. The trimming obtained is usually crude and rough.

Fifth: the ring may migrate proximally over the glans with protrusion of the glans through the distal end of the migrating ring causing constriction of penis which if not discovered early may lead to ischemic necrosis of the distal part of penis. Also, there is possibility of fistula formation.

Sixth: it is suitable to achieve low circumcision until the frenulum is divided in an additional step. If the frenulum is not divided the ring will be seated distal than the desired position ventrally.

Another circumcision device is described in U.S. Patent No. 2010/0168757 A1 by David. The device is complex to operate, need a skilled physician to deal with it, and is not suitable for all users.

Another shortcoming of the device is that a gap in the ring and the foreskin is drawn over it. The clamping action will not result in crushing of the foreskin at the point opposite to the gap; the result cutting causes a bleeding at this point.

Another shortcoming is that there is a chance of trapping the lever arm and is not reaching the closed position, making the circumcision procedure is difficult and dangerous. Another shortcoming is that the circumcision style achieved by this device is loose and moderately but not completely low. The device is not suitable for other circumcision styles.

Disclosure of the invention

An object of the present invention is to avoid any necessity of dressing to be applied to the site of surgery.

Another object of the present invention is a safety procedure through providing glans penis protection.

Another object of the present invention is to provide a ring which has a notch to embrace the frenulum so there is not obligatory to cut the frenulum to achieve the desired circumcision style.

Another object of the present invention is to provide a device suitable for patients with bleeding tendency and hemophilia patients.

Another object of the present invention is to provide a device with an angled ring to match the natural slant of the coronal rim of the glans.

Another object of the invention is that the device is of a simple design so that it can be fitted and can be handled by both hands of a single person without effort and with easy and simple steps.

Another object of the present invention is to provide a device for performing circumcisions which is economical to manufacture.

In accordance with the previous objects of the present invention, the device includes a transparent supporting tube, an angled ring, and two clamps. The transparent supporting tube includes an open anterior end, an open posterior end and at least two grooves circumferentially defined around the outer periphery of the tube.

The anterior end of the transparent tube includes a circumferential protrusion which acts as a supporting handle of the device. In one embodiment of the present invention, the transparent supporting tube includes L-shaped slit which act as a female part of bayonet joint. The slits positions are at two peripheral points of one diameter.

In one embodiment of the present invention, the angled ring includes an open anterior end, and an open posterior end. The angled ring has one side is longer than the other side. This difference in length between the two sides will create an angle between the longitudinal axis of the device 2A and the base of the device 1 1 (the posterior end of the ring). The angle 2x is an acute angle; ranged from 55° to 70°. This angle matches the natural inclination of the glans penis on the axis of the shaft of the penis.

In one embodiment of the present invention, the angled ring includes at least two pins which act as the male part of the bayonet joint. The pins positions are at two peripheral points of one diameter.

In one embodiment of the present invention, the angled ring includes two circumferential flanges at the posterior end. This will form a groove in- between these two flanges. The clamping action of the foreskin is applied to this groove and is kept in place in-between the two flanges. The angled ring includes a circumferential groove around an outer periphery of the angled ring, with about 2-3 mm. lengths from the circumferential flange. This groove does not include flanges and is not protruded to the inside wall of the angled ring. The cutting action of the prepuce is applied to this groove to produce a well trimmed cut.

In another embodiment of the present invention, the angled ring includes an extension at one sector of the posterior end; this extension is about 2 mm. lengths from the edge of the angled ring; the lower flange.

This extension includes a notch to embrace the frenulum. This sector is at the shorter side of the angled ring. This extension is smoothly decreased in length, on both sides of the notch, till it completely disappear and meet the peripheral circumferential flange. The transparent supporting tube and the angled ring are locked together through the bayonet joint. The two pins of the angled ring are aligned with the vertical limp of the L-shaped part. The supporting tube and the ring are pushed together. Once the two pins reach the bottom of the vertical limp, the tube and the ring are turned in opposite directions to guide the pins across the transverse limp of L-shaped part of the joint.

The pins are preferred to be in the same plane of the notch.

In other embodiment of the present invention, there are two clamps by two mechanisms. One clamp is used as a fixing clamp to maintain the foreskin of the penis in a proximal position.

The other clamp is the constricting one which is applied over the angled groove in-between the two circumferential flanges at the posterior end of the angled ring. The foreskin tissue is compressed between the angled groove of the angled ring and the clamp. The foreskin tissue becomes necrotic above the constricting clamp and usually drop off, with the angled ring, by itself once healing is achieved. This usually takes about 3-5 days. The device is of a simple design, and the transparent tube and the angled ring are manufactured from a non- compressible, or minimally compressible plastic material such as, but not limited to, silicone, polyethylene, polyether and the like.

The inner surface of the angled ring which comes in contact with the glans should be soft to ease placement of the angled ring over the glans. This will decrease the pain and reduce friction during positioning of the angled ring. In other embodiment of the present invention, the clamp is selected from a group including a rubber, silk, linen, nylon and the like. Detailed Description of the invention

Referring to FIG.1 , transparent supporting tube 1 is shown which includes an open round anterior end 6 and an open round posterior end 7.

The transparent supporting tube is conical in shape, with the posterior round end is larger than the anterior round end. The transparent supporting tube 1 can be cylindrical in shape. The transparent supporting tube 1 includes at least two grooves 3 circumferentially defined around an outer periphery of the supporting tube 1.

The size of the posterior end 7 is modified to receive different sizes of the angled ring 2. The size of the anterior end 6 is changed to match the change in size of the posterior end 7.

The supporting tube 1 is supported by circular protrusion 4 around the anterior round end 6 which acts as a handle of the device.

The inner diameter of the transparent supporting tube at the posterior end

7 is greater than the outer diameter of the angled ring, such that the transparent supporting tube may be fitted over the angled ring 2.

There is a circumferential ridge 5 at the inner side of the supporting tube 1 , which acts as limit for the angled ring 2.

Referring to FIG.2, Angled ring 2 is shown which includes an open anterior end 12 and an open posterior end 1 1. The angled ring 2 has one side 2A is longer than the other side 2B. This difference in length in between the 2 sides will create an angle 2x between the longitudinal axis of the ring and the base of the ring 2, which is an acute angle. This angle matches the natural posterior inclination of the glans penis on the longitudinal axis of the penis. The angled ring 2 includes at least two pins 8 on both sides as shown in the illustration which is the male side of bayonet connector or joint.

The angled ring 2 includes two circumferential flanges at the posterior end 11 , as shown in the illustration. This will form a groove in-between these two flanges 10.

The angled ring 2 includes a circumferential defined groove around an outer periphery of the angled ring, with about 2-3 mm. distances from the circumferential flange. This groove is parallel to the formed groove in- between the two circumferential flanges. This groove does not include flanges and is not protruded to the inside wall of the angled ring. The angled ring 2 further includes an extension at one sector of the posterior end 1 1 ; this extension is about 2 mm. lengths from the edge of the angled ring. The sector is at the shorter side 2B of the angled ring 2.

This extension includes a notch 14 (not shown) to embrace the frenulum. This extension is smoothly decreased, on both sides of the notch, till it disappear and meet the peripheral circumferential flange as illustrated 13. FIG.3 is sectional views of the two member of the invention, taken along line A-A in FIG.1.

FIG.4 is sectional views of the invention, taken along line A-A in FIG.1 , with the 2 members are locked.

FIG.5 is a sectional view of the upper member of the invention, taken along line B-B in FIG.5. This view shows the female side of bayonet joint 14. This part of the joint is L shaped and acting as a female receptor of the other matching male part of the bayonet joint 8.

To couple the two parts of the bayonet joint, the pins 8 are aligned with the vertical limp of the L shaped part and the two members of the invention; the transparent supporting tube 1 and the angled ring 2, are pushed together. Once the pins 8 reach the bottom of the vertical limp of L shaped part 14, the two member of the invention 1 and 2 are turned in opposite directions to guide the pins 8 across the transverse limp of L shaped part of the joint. The inside circumferential ridge 5 then helps holding the two members of the invention together.

FIG.6 is a sectional view of the lower member of the invention, taken along line B-B in FIG.5. The notch 14 appears clearly in this sectional view.

FIG.7 is sectional views of the invention, taken along line B-B in FIG.5, with the 2 members are unlocked.

FIG.8 is other sectional views of the invention, taken along line B-B, taken with the 2 members are locked. This view shows the male 8 and female 14 parts of bayonet joint, with the two parts locked together.

FIG.9 is a sectional view of the measuring guide. It is a flat, rectangular plate; other shapes are possible, having a number of circular openings which are arranged in two rows.

Theses circular openings 15 are of progressively increasing diameters. The edges of the openings are smoothly rounded. The size of each opening is marked beside it x1-x6. This measuring guide is used for determining the appropriate size of the ring to be used for circumcision. Each circular opening represents the different sizes of the angled ring 2. These circular openings can be collected in two measurement plates as child and adult ones. The measuring guide is packed separately in a sterile package therefore helps to avoid unnecessary opening and contamination of many sealed and sterile package of the main device to determine and select the right size for circumcision. It is used by inserting the flaccid penis through these circular openings. The smallest opening which the flaccid penis can be inserted through it easily represents the correct size of the angled ring to be used. FIG.10 shows the posterior inclination of the glans penis on the longitudinal axis of penis.

FIG.11 is sectional views of the penis and device, taken along plane C. Angle Xb is between the glans and the longitudinal axis of the shaft of the penis and angle Xc is between the longitudinal axis of the device and the posterior end of the angled ring.

Referring to FIG.12 (a) to FIG.12 (I) illustrate the steps of circumcision using the present invention.

FIG.12 (a) after measuring the diameter of the glans at the level of the corona, using the measuring guide provided. The two member of the device are locked together using bayonet joint.

FIG.12 (b) the amount of the foreskin to be removed is marked by surgical marker. Local anesthesia is applied or injected at base of the penis. Free all adhesions and then cleaning of the glans penis thoroughly. Dilate the prepuce opening (not shown).

FIG.12(c) Insert the device between the foreskin and the glans; with the side of the notch directed to the ventral side of the penis to embrace the frenulum. Usage of anesthetic gel is possible to facilitate the device insertion (not shown). The foreskin is gently pulled and stretched over the transparent supporting tube.

FIG.12 (d) nylon tie or non returned clamp 16 is positioned over at least one circumferentially defined groove around the outer surface of the transparent supporting tube and before closing the clamp tight.

Adjust the position of the angled ring groove to be aligned with the marked position of the foreskin to be cut.

Then, tighten this clamp which maintains the foreskin in proximal position over the tube and to keep angled ring in proper position for clamping.

FIG.12 (e) another clamp 17 is applied over the groove of the angled ring 10 in-between the palpable two circumferential flanges. FIG.12 (f) cutting of the excess foreskin stretched over the transparent supporting tube is carried out using surgical blade over the circumferential groove 9 around the angled ring which is 2-3 mm from the clamping site. FIG.12 (g) Fixing the angled ring by one hand and slight anti-clockwise twist is applied to the transparent supporting tube; to unlock the bayonet joint. Therefore, the transparent supporting tube with the cut excess foreskin with overlying clamp is removed.

FIG.12 (h) illustrates the angled ring is fixed to the glans penis by clamping the remaining part of the foreskin.

FIG.12 (I) illustrates the end result of circumcision. The angled ring will drop off by itself once healing is achieved. This usually takes about 3-5 days.

FIG.13 steps to do a non return slip knot. S1 is the first half hitch. S2 is four round turns. S3 is a second half hitch.

FIG.14 shows the beaded nylon tie as a fixing clamp.

Brief descriptions of the drawings

FIG.1 is a sectional view of the upper member of the invention, taken along line A-A.

FIG.2 is a sectional view of the lower member of the invention, taken along line A-A in FIG.1.

FIG.3 is sectional views of the invention, taken along line A-A in FIG.1 , with the 2 members are unlocked.

FIG.5 is a sectional view of the upper member of the invention, taken along line B-B.

FIG.6 is sectional view of the invention, taken along line B-B in FIG.5.

FIG.8 is sectional views of the lower member of the invention, taken along line B-B in FIG.5, with the 2 members of the invention are locked.

FIG.9 is a sectional view of the measuring guide.

FIG.10 shows the posterior inclination of the glans penis.

FIG.11 is sectional views of the penis and device, taken along plane C.

FIG.12 (a) to FIG.12 (I) illustrate the steps of circumcision using the present invention.

FIG.13 steps to do a non return slip knot.

FIG.14 shows the beaded nylon tie as a fixing clamp.

Claims

1. A disposable device for circumcision by producing ischemic necrosis in the foreskin of a penis, said device includes:

a transparent supporting tube, an angled ring, and two clamps.

2. The device of claim 1 , wherein said transparent supporting tube is conical in shape, with the posterior end is larger than the anterior end.

The transparent supporting tube includes at least two grooves circumferentially defined around an outer periphery of the supporting tube.

3. The device of claim 2, wherein said the supporting tube is supported by circular protrusion around the anterior round end.

4. The device of claim 2, wherein said supporting tube includes a circumferential ridge at the inner side of the supporting tube, which acts as limit for the angled ring.

5. The device of claim 1 , wherein said angled ring includes an open anterior end and an open posterior end. The angled ring has one side is longer than the other side.

This difference in length between the two sides will create an angle between the longitudinal axis of the device and the base of the device (the posterior end of the ring). The angle is an acute angle; ranged from 55° to 70º.

6. The device of claim 5, wherein said angled ring includes two circumferential flanges at the posterior end. This will form a groove in- between these two flanges.

7. The device of claim 5, wherein said angled ring includes a circumferential defined groove around an outer periphery of the angled ring, with about 2-3 mm. distances from the circumferential flange. This groove is parallel to the formed groove in-between the two circumferential flanges. This groove does not include flanges and is not protruded to the inside wall of the angled ring.

8. The device of claim 5, wherein said angled ring includes an extension at one sector of the posterior end; this extension is about 2 mm. lengths from the edge of the angled ring. This extension is smoothly decreased, on both sides of the notch, till it disappear and meet the peripheral circumferential flange.

9. The device of claim 1 , wherein said angled ring and transparent supporting tube are connected together by bayonet joint with 2 pins at the angled ring and L-shaped receptor at the transparent tube.

10. The device of claim 1 , wherein said clamps are manufactured from silk, nylon, rubber, latex, and the like.