WO2019159087A1

WO2019159087A1 - A circumcision device with removable parts

Info

Publication number: WO2019159087A1
Application number: PCT/IB2019/051180
Authority: WO
Inventors: Monir AL MANSOUR
Original assignee: Universita' Degli Studi Di Roma "La Sapienza"
Priority date: 2018-02-19
Filing date: 2019-02-14
Publication date: 2019-08-22
Also published as: IT201800002796A1

Abstract

Circumcision device, including a support (10), a rest part (20) comprising a stem (21) and a shearing template (23) arranged fastened on a distal end of the stem (21), which has a concave distal surface (23a) and a side surface (23b) tapered in the proximal direction, and a pair of arms (30, 30') each having a distal end provided with a semi-circular blade (32, 32'). Each arm is rotatable around an axis perpendicular (y, y') to the extension direction of the stem (21), between an open position and a shearing position wherein the semi- circular blades (32, 32') are closed to form a ring perpendicular to the extension axis of the stem (21) and have a cutting edge (33, 33') that engages the side surface (23b) of the shearing template (23). The rest part (20) is removably fastened to the support (10) and the semi-circular blades (32, 32') are removably fastened to their respective levers (30, 30'). Each lever (30, 30') is provided with a guide (31a, 31a') to determine the orientation of the respective semi-circular blade (32, 32').

Description

A circumcision device with removable parts

This invention generally refers to circumcision techniques.

Circumcision is a ritual procedure and from a religious point of view is respected and so deeply rooted that, at times, it is performed without the minimum requirements of safety or respect for the anatomy of the glans. Consequently, the damage resulting from the use of unsuitable procedures is considerable, both for the patient who must resort to plastic- reconstructive procedures, and for the national health service that must pay for them.

In some cases, circumcision is also required to correct certain pathologies of the male genital organ.

Circumcision operations are usually carried out with the aid of clips that stretch the foreskin to be removed using a scalpel.

From US2013/0079795 a circumcision device is known comprising

a support,

a rest part integral with the support and comprising a stem and a shearing template arranged at a distal end of the stem, said shearing template having a concave distal surface and a side surface at least partially tapered in the proximal direction, and

a pair of levers hinged to the support, each having a distal end provided with a semi-circular blade, each lever being rotatable about an axis perpendicular to the extension direction of the stem, between an open position and a shearing position wherein the semi- circular blades are closed to form a ring perpendicular to the extension axis of the stem and have a cutting edge that engages the side surface of the shearing template.

One of the objects of the present invention is to make available a circumcision device that is economically feasible and that allows one to operate in guaranteed hygienic conditions.

In view of such objects, the aim of the invention is a circumcision device of the type defined above, wherein the rest part is removably fastened to the support and the semi-circular blades are removably fastened to the respective levers, wherein each lever is provided with guide means adapted to determine, during fastening, the orientation of the respective semi circular blade relative to the rest part.

In the device according to the invention, the rest part and the semi-circular blades, in contact with the glans and the foreskin of the patient, may be made as disposable parts, while the rest of the device may be reused. In the case wherein the rest part and the blades are supplied in sterile conditions, this ensures that the operation is carried out with the utmost hygiene.

In addition, it is possible to produce the rest part and the semi-circular blades in different formats, which may be used selectively depending on the size of the glans on which the operation will be performed.

Due to the presence of the guide means on each lever, the fastening of each semi-circular blade to the respective lever may provide for a rotation movement of the semi-circular blade around a longitudinal axis of the lever, from a first position, wherein the cutting edge of the semi-circular blades faces away from the rest part, to a second position, wherein the cutting edge of the blades faces towards the rest part, and a translation movement of the semi-circular blade along the longitudinal axis of the lever. In this way it is possible to mount the blades during a preliminary step of the procedure, when the glans is already positioned on the rest part, with the foreskin resting on the outer side surface of the rest part. Such mounting occurs in a way that is safe for the patient, as the cutting edge of the blades does not face the penis during the initial mounting step.

Preferred embodiments of the invention are defined in the dependent claims, which are intended as an integral part of the present description.

Further features and advantages of the device according to the invention will become more apparent in the following detailed description of an embodiment of the invention, made with reference to the accompanying drawings, provided purely to be illustrative and non- limiting, wherein:

- figures 1 and 2 are views in elevation of a circumcision device according to the present invention, respectively in the shearing position and in the open position;

- figure 3 is a view corresponding to figure 1, wherein some inner parts of the device are highlighted with dotted lines;

- figure 4 is a view corresponding to figure 1, wherein the device is represented in cross-section;

- figures 5a and 5b are respectively a front view and a view in cross-section of a rest part of the device in figures 1 and 2;

- figures 6a and 6b are respectively a front view and a view in cross-section of a first semi-circular blade of the device in figures 1 and 2;

- figures 7a and 7b are respectively a front view and a view in cross-section of a second semi-circular blade of the device in figures 1 and 2;

- figures 8a and 8b are respectively a view in elevation and a view in cross-section of a lever of the device in figures 1 and 2; and

- figures 9a and 9b are respectively a perspective view and a plan view of a support stem for the blades in figures 7a- 7b and 8a-8b.

With reference to the figures, a circumcision device is represented, indicated collectively at

1.

The device 1 comprises a support 10, which in the example illustrated comprises two plates 1 1 and 12, as well as a support block 13 which interconnects them and to which the plates 11 and 12 are fastened (visible in particular in figure 4).

The device 1 further comprises a rest part 20 integral with the support 10 and comprising a stem 21 and a shearing template 23 arranged on a distal end of the stem 21. The proximal end of the stem 21 is removably fastened in a seat 14 made in the support block 13. To this end, in the example shown, the first snap fastening means are provided on the support and are adapted to engage a corresponding groove made on the stem 21 of the rest part 20. In the example illustrated, such first snap fastening means comprise a snap-in set screw 25 mounted on a wall of the seat 14 and adapted to engage a groove 26 made on a side surface of the stem 21 (shown in figure 5b). The snap-in set screw 25 is of a type known per se, for example, of the type comprising a hollow body, having an outer side surface provided with a thread and containing a movable element (for example, a ball) partially emerging from one end of the hollow body, and a spring interposed between the movable element and the opposite end of the hollow body. Naturally, the invention is not limited to the use of a connecting set Screw; rather it is possible to use alternative means that still allow a snap fastening.

With particular reference to figures 5a and 5b, the shearing template 23 of the rest part 20 has substantially a bell shape and has a concave distal surface 23a and a side surface 23b at least partially tapered in the proximal direction. In particular, the side surface 23b of the shearing template 23 comprises two distinct areas in the extension direction of the stem 21 and has a different slope in the extension direction of the stem 21. Such two areas are separated from each other by a groove 23c made on the side surface 23b. An abutment ring element 23d is housed in the groove 23c. Such abutment ring element 23d is made of a material that is more yielding than the material of which the shearing template 23 is made. Generally, the shearing template 23 may be made of a metallic material, while the abutment ring element 23d may be made of plastic or an elastomeric material.

The device 1 further comprises a pair of levers, indicated at 30 and 30’, which are hinged to the support 10, and, in particular, to the pair of plates 11 and 12. In the figures, the rotation axes of the levers 30 and 30’ are indicated at y and y\ One of the levers, indicated at 30, has a pin 30a coupled with a slot 30a’ made in the other lever, 30’. At its proximal end, each lever 30, 30’ is provided with a ring, respectively indicated at 30b and 30b’. The rings 30 and 30b’ are adapted to be held by corresponding fingers of one hand to control the opening and closing of the levers 30 and 30’ of the device 1. The open position of the levers 30, 30’ is represented in figure 2, while the closed position, or shearing position, is represented in figures 1, 3 and 4.

At the distal end of each lever 30, 30’ a seat 31, 31’ is made extending along a longitudinal axis z, z’ of the respective lever. The seats 31, 3 G are used to fasten the respective blades of the circumcision device. At its distal end, each lever 30, 30’ is in effect provided with a semi-circular blade, respectively indicated at 32 and 32’. In the shearing position, the semi-circular blades 32, 32’ are closed to form a ring perpendicular to the extension axis of the stem 21 and have a cutting edge 33, 33’ that engages the side surface 23b of the shearing template 23, in particular, at the groove 23c made on such side surface 23b.

With reference to figures 6a-6b and 7a-7b, each semi-circular blade 32, 32’ has a main working surface 32a, 32a’ with a curved profile, tapered in the distal direction, whereon is arranged a curved cutting edge 33, 33’. Such cutting edge forms a closed curve when the blades 32, 32’ are in the shearing position. Such closed curve may be, for example, circular or elliptical.

Each blade 32, 32’ furthermore has a pair of secondary working surfaces 32b, 32c; 32b’, 32c’, arranged on diametrically opposite sides of the main working surface 32a, 32a’ of the respective blade 32, 32’. The pair of secondary working surfaces 32b’, 32c’ of one of the blades, 32’, is provided with a secondary cutting edge 34’. The other pair of secondary working surfaces 32b, 32c is substantially flat and is adapted to receive the secondary cutting edge 34’ when the blades 32, 32’ are in the shearing position. With reference to figures 8a-8b and 9a-9b, the semi-circular blades 32, 32’ are removably fastened to the respective levers 30, 30’. For this purpose, each semi-circular blade 32, 32’ is made integral to a stem 35 (represented by itself in figure 9a), at a distal end 35a thereof. Each stem 35 extends substantially orthogonally to a plane defined by the cutting edge 33, 33’ of the respective blade 32, 32’. Moreover, in the example illustrated, there are second snap fastening means arranged on each lever 30, 30’ and adapted to engage a corresponding groove made on the stem 35 of the respective semi-circular blade 32, 32’. In the example illustrated, such second snap fastening means comprise a snap-in set screw 36, 36’ mounted on a wall of the seat 31 , 3 G of each lever 30, 30’, and adapted to engage a groove 37 made on a side surface of the stem 35 (shown in figure 9a) of the respective semi-circular blade 32, 32’. The snap-in set screws 36, 36’ are of a type known per se, for example, of the type comprising a hollow body, having an outer lateral surface provided with a thread and containing a movable element (for example, a ball), partially emerging from one end of the hollow body, and a spring interposed between the movable element and the opposite end of the hollow body. Naturally, the invention is not limited to the use of a connecting set screw; rather it is possible to use alternative means that still allow a snap fastening.

Each lever 30, 30’ is further provided with guide means adapted to determine, during fastening, the orientation of the respective semi-circular blade 32, 32’ relative to the rest part 20. To this end, in the example illustrated, the stem 35 of each semi-circular blade 32, 32’ comprises (in the extension direction of the stem) a first length 38 with a circular cross- section adjacent to the groove 37, and a second length 39 with a non-circular cross-section away from the groove 37. As may be seen in the example in figure 9b, the second length 39 has a flat-shaped cross-section, delimited by two opposing circumferential arcs and two opposing straight segments. The distance between the straight segments is equal to the diameter of the first length 38 with circular cross-section, and smaller than the diameter of the circumference defined by the two opposing arcs. The second length 39 of each stem 35 is adapted to form a prismatic pair with an inner surface of the seat 31, 3 G of the respective lever 30, 30’. In the example illustrated, in effect, each seat 31, 3 G has at the distal part thereof a straight slot 3 la, 3 la’ having a width equal to the distance between the straight segments of the second length 39 of the stem 35.

Due to the arrangement described above, it is possible to insert the first length 38 of the stem 35 of each semi-circular blade 32, 32’ into the seat 31, 3 G of the respective lever 30, 30’, until the second length 39 rests against the distal end of the lever 30, 30’, and thus rotates the semi-circular blade 32, 32’ about the respective axis z, z’ until the straight segments of the second length 39 are aligned with the respective slot 3 la, 3 la’. Once such alignment has been obtained, it is possible to push each blade 32, 32’ in the direction of the respective axis z, z’, until it engages with the respective lever 30, 30’.

In other words, the fastening of each semi-circular blade 32, 32’ to the respective lever 30, 30’ may provide for a rotation movement of the semi-circular blade 32, 32’ about the longitudinal axis z, z’ of the lever 30, 30’, from a first position, wherein the cutting edge 33, 33’ of the semi-circular blades 32, 32’ is facing away from the rest part 20, to a second position, wherein the cutting edge 33, 33’ of the blades is facing toward the rest part 20, and, in any event, provides for a translation movement of the semi-circular blade 32, 32’ along the longitudinal axis z, z’ of the lever. Preferably, the device described above further comprises a locking member that may be actuated to lock the levers 30, 30’ relative to the support 10, when the levers 30, 30’ are in the closed position. For example, in the embodiment illustrated, the locking member consists of a knob 40 mounted rotatably on the support 10, which may be actuated in such a way as to directly lock one of the levers 30’, and indirectly the other lever 30 due to the connection between the pin 30a and the groove 30a’. Naturally, other locking means may also be used to achieve the same function. For example, it is possible to equip each lever, in proximity of the rings 30b and 30b’, with a rack or pinion adapted to engage a corresponding rack or pinion made on the other lever. The operation begins with a local anesthesia, via injection or ointment, or sedation. Operatively, the surgeon inserts the concave distal surface 23a of the shearing template 23 onto the tip of the glans for the protection thereof and slides the foreskin onto the outer surface 23 b of the same, while the device is in the open position. At this point the semi-circular blades 32, 32’ are carried on the respective levers 30, 30’, initially holding them with the respective cutting edges 33, 33’ facing away from the penis. They are then fastened to the levers, this fastening providing for the rotation of the blades and the subsequent coupling in the manner described above. At this point the two layers of the foreskin are exposed against the two semi-circular blades. When levers 30, 30’ are actuated, such blades close synchronously, making a cut and a compression on the portion of the foreskin positioned on the end part of the side surface 23b of the bell-shaped template, at the abutment ring element 23d. Once the section is made, the device is kept closed for a certain period of time, after which the two blades are reopened, and the excess foreskin is removed. In this way the foreskin is reshaped.

As may be appreciated, once closed, the semi-circular blades correspond in a geometrically perfect way with the outer surface of the shearing template and make a circular-shaped cut in a section thereof, with an area near to the cut compressed and consolidated. The result is a minimally invasive procedure, that is safe, quick and easy-to-use. The procedure does not require more than a few minutes of operation. Once the operation is finished, unlike other devices, the patient only has to wear a small circular gauze dressing for about two days.

Claims

1. Circumcision device (1) including

a support (10),

a rest part (20) integral with the support (10) and comprising a stem (21) and a shearing template (23) arranged at a distal end of the stem (21), said shearing template having a concave distal surface (23a) and a side surface (23b) at least partially tapered in the proximal direction.

a pair of levers (30, 30’) hinged to the support (10), each lever having a distal end provided with a semi-circular blade (32, 32’), each lever (30, 30’) being rotatable about an axis perpendicular (y, y’) to the extension direction of the stem (21), between an open position and a shearing position wherein the semi-circular blades (32, 32’) are closed to form a ring perpendicular to the extension axis of the stem (21) and have a cutting edge (33, 33’) that engages the side surface (23b) of the shearing template (23),

characterized in that

the rest part (20) is removably fastened to the support (10) and the semi-circular blades (32, 32’) are removably fastened to the respective levers (30, 30’), wherein each lever (30, 30’) is provided with guide means (3la, 3la’) adapted to determine, during fastening, the orientation of the respective semi-circular blade (32, 32’) relative to the rest part (20).

2. Device according to claim 1, further comprising first snap fastening means (25) arranged on the support (10) and adapted to engage a corresponding groove (26) made on the stem (21) of said rest part.

3. Device according to claim 2, wherein a seat (14) adapted to receive the stem (21) of the rest part (20) is made in the support (10), said first snap fastening means being arranged on a wall of said seat.

4. Device according to any one of the preceding claims, further comprising second snap fastening means (36, 36’) arranged on each lever (30, 30’) and adapted to engage a corresponding groove (37) made on a stem (35) of the respective semi-circular blade (32, 32’).

5. Device according to claim 4, wherein a seat (31 , 3 G) adapted to receive the stem (35) of the respective semi-circular blade (32, 32’) is made in each lever (30, 30’), said second snap fastening means being arranged on a wall of said seat.

6. Device according to claim 4 or 5, wherein the stem (35) of the semi-circular blade

(32, 32’) comprises a first length (38) with circular cross-section adjacent to the groove (37), and a second length (39) with non-circular cross-section far from the groove (37), said second length being adapted to form a prismatic pair with an inner surface (3 la, 3 l a’) of said seat.

7. Device according to any one of the preceding claims, wherein in the shearing position the cutting edge (33, 33’) of the semi-circular blades (32, 32’) engages the side surface (23b) of the shearing template (23) at an abutment ring element (23d) arranged between zones of the side surface (23b) having different slopes in the extension direction of the stem (21), said abutment ring element being made of a softer material than the shearing template (23).

8. Device according to any one of the preceding claims, wherein each semi-circular blade (32, 32’) has a main working surface (32a, 32a’) having a curved profile and being tapered in the distal direction, on which a curved cutting edge (33, 33’) is arranged, said cutting edge forming a closed curve when the blades (32, 32’) are in the shearing position.

9. Device according to claim 8, wherein each blade (32, 32’) has a pair of secondary working surfaces (32b, 32c; 32b’, 32c’) arranged on diametrically opposite sides of the main working surface (32a, 32a’) of the respective blade (32, 32’), the secondary working surfaces (32b, 32c) of one of the blades engaging the secondary working surfaces (32b’, 32c’) of the other blade when the blades are in the shearing position.

10. Device according to claim 9, wherein the pair of secondary working surfaces (32b’_; 32c’) of one of the blades is provided with a secondary cutting edge (34’), the other pair of secondary working surfaces (32b, 32c) being adapted to receive the secondary cutting edge (34^‘) when the blades are in the shearing position.