WO2009091235A2

WO2009091235A2 - A non-reusable circumcision clamp

Info

Publication number: WO2009091235A2
Application number: PCT/MY2008/000195
Authority: WO
Inventors: Ismail Hj. Salleh, Md.
Original assignee: Individual
Current assignee: Individual
Priority date: 2008-01-16
Filing date: 2008-12-23
Publication date: 2009-07-23
Anticipated expiration: 2010-07-16
Also published as: MY152546A; WO2009091235A3

Abstract

The present invention provides a non-reusable circumcision clamp and a method of circumcision using the circumcision clamp. The circumcision clamp enables a relatively painless circumcision procedure.

Description

A NON-REUSABLE CIRCUMCISION CLAMP

FIELD OF INVENTION

The present invention relates to a non-reusable circumcision clamp.

BACKGROUND ART

Circumcision is one of the oldest surgical procedures in medicine, with the first circumcision procedure reported about 15,000 years ago. Although the origin of circumcision is still unknown, the earliest evidence of this practice dates from ancient Egypt 2300 BC.

Over the centuries, circumcision had assumed a religious significance. An initiatory rite of Judaism, circumcision is now being widely practiced by Muslims, for whom it is obligatory for every adult Muslim and it signifies spiritual and physical purification.

Currently, it is estimated that one in six males are circumcised, and every year there are about 15 million post-infancy circumcisions performed worldwide. This makes circumcision the most commonly performed elective surgical procedure. With the spread of HIV/AIDS and the awareness of the beneficial health effects of circumcision, the number of male circumcisions are expected to be on the rise.

Traditionally, circumcision was performed with the free hand technique whereby after excision of the foreskin, the wound edges were not stitched together. The main problem associated with this traditional method is the pain sensation. Other associated problems are excessive bleeding, infection and poor wound healing or healing by secondary intention.

Efforts were made to make circumcision safer with the protection of the glans penis and to minimize bleeding, as well as making it a faster procedure to perform. In 1920 Moskovich first envisioned bloodless circumcision when he invented the circumcision forceps. These forceps did not gain wide acceptance probably because of its poor cosmetic result.

Subsequently, circumcision clamps were invented. For one reason or another, most of the clamps were not popular and had become obsolete.

Non-reusable clamps then became more popular because they were relatively safer, the bleeding was minimal, the circumcision procedure was relatively faster and the cosmetic outcome was relatively better. With the use of the non-reusable circumcision clamps, individuals who underwent the circumcision procedure were not being confined and their normal activities were not compromised.

With the advent of aseptic technique, ATT, analgesia, sutures and antibiotics, circumcisions performed today are relatively safe and painless. However, there are problems such as accidental amputation of the glans penis, bleeding, infection and poor cosmetic results.

However all existing non-reusable clamps cause a substantial amount of pain during the removal process and post removal of clamp complication is common, particularly penis swelling, wound dehiscent and infection which invariably leads to poor and delayed wound healing. SUMMARY OF THE INVENTION

Accordingly, there is provided a circumcision clamp, wherein the clamp includes a first clamping mechanism, a second clamping mechanism and a third clamping mechanism characterized in that, the first clamping mechanism is inserted onto a glans penis, wherein the first clamping mechanism is a hollow structure that includes a lower portion, an intermediate portion and an upper portion, wherein the lower portion includes an opening with a protruding circular plate with a suitably constructed edge to accommodate the glans penis, the intermediate portion includes an anti-rotational mechanism and the upper portion includes an opening with an externally threaded portion, the second clamping mechanism holds the glans penis in anatomical position during circumcision procedure, wherein the second clamping mechanism includes a lower base plate, an upper base plate and a spacing structure, wherein the lower base plate includes an opening constructed suitably to rest on the protruding circular plate, the upper base plate includes an anti-rotational mechanism to engage the anti-rotational mechanism of the first clamping mechanism and an opening constructed suitably to accomodate the externally threaded portion of the first clamping mechanism, and the third clamping mechanism includes an internally threaded portion to engage the externally threaded portion of the first clamping mechanism.

One aspect of the present invention is to achieve a clean cut of the prepuce during the circumcision procedure with minimal pain and bleeding.

Further, there is also provided a method of circumcision using a circumcision clamp that includes a first clamping mechanism, a second clamping mechanism and a third clamping mechanism characterized in that, the first clamping mechanism is inserted onto a glans penis, wherein the first clamping mechanism is a hollow structure that includes a lower portion, an intermediate portion and an upper portion, wherein the lower portion includes an opening with a protruding circular plate with a suitably constructed edge to accommodate the glans penis, the intermediate portion includes an anti-rotational mechanism and the upper portion includes an opening with an externally threaded portion, the second clamping mechanism holds the glans penis in anatomical position during circumcision procedure, wherein the second clamping mechanism includes a lower base plate, an upper base plate and a spacing structure, wherein the lower base plate includes an opening constructed suitably to rest on the protruding circular plate, the upper base plate includes an anti- rotational mechanism to engage the anti-rotational mechanism of the first clamping mechanism and an opening constructed suitably to accomodate the externally threaded portion of the first clamping mechanism, and the third clamping mechanism includes an internally threaded portion to engage the externally threaded portion of the first clamping mechanism, wherein, the method of circumcision includes inserting the first clamping mechanism into the glans penis through opening of the lower portion of the first clamping mechanism, then inserting the second clamping mechanism onto the first clamping mechanism through opening of the lower base plate of the second clamping mechanism such that the anti-rotational mechanism of the upper base plate engages into the anti- rotational mechanism of the first clamping mechanism, then engaging the third clamping mechanism onto the externally threaded portion of the first clamping mechanism, then removing a prepuce at a gap between the first clamping mechanism and second clamping mechanism and finally disengaging the third clamping mechanism, followed by removal of the second clamping mechanism and detachment of first clamping mechanism.

By use of this aspect of the present invention, the circumcision procedure that includes the insertion of the clamp, the circumcision of the penis and the removal of the clamp can be achieved in a systematic manner. The present invention consists of several novel features and a combination of parts hereinafter fully described and illustrated in the accompanying drawings, it being understood that various changes in the details may be made without departing from the scope of the invention or sacrificing any of the advantages of the present invention.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

For the purpose of facilitating and understanding of the present invention, there is illustrated in the accompanying drawings, from an inspection of which, when considered in connection with the following description, the invention, its construction and operation and many of its advantages would be readily understood and appreciated.

FIG. 1 is a perspective view of the circumcision clamp according to the preferred embodiment of the present invention.

FIG. 2 is a cross sectional diagram of the circumcision clamp.

FIG. 3 is a perspective view of the inner tube.

FIG. 4 is a cross sectional diagram of the inner tube across the line A-A in FIG. 3.

FIG. 5 is a perspective view of the clamp holder.

FIG. 6 is a cross sectional diagram of the clamp holder across the line B-B in FIG. 5.

FIG. 7 is a perspective view of the screw nut.

FIG. 8 illustrates the steps involved during the circumcision procedure using the circumcision clamp in FIG. 1.

FIG.9 is a perspective view of the measuring device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to a non-reusable circumcision clamp. Hereinafter, this specification will describe the present invention according to the preferred embodiments of the present invention. However, it is to be understood that limiting the description to the preferred embodiments of the invention is merely to facilitate discussion of the present invention and it is envisioned that those skilled in the art may devise various modifications and equivalents without departing from the scope of the appended claims.

The circumcision clamp of the present invention is provided with three clamping mechanisms that function to provide for a hygienic and less traumatic circumcision procedure. FIG. 1 illustrates a perspective view of the circumcision clamp. FIG. 2 is the cross sectional view of all three clamping mechanisms of the circumcision clamp in place.

The first clamping mechanism is an inner tube (1) as shown in FIG. 3. The inner tube (1) is a hollow tubular structure that has three main portions, namely a lower portion (33), an intermediate portion (34) and an upper portion (35). The inner tube (1) is inserted onto the glans penis to provide protection of the glans penis and the frenulum during the circumcision procedure.

The lower portion (33) of the inner tube (1) is a coned shaped structure that includes an opening (4) with a protruding circular plate (6). The circular plate (6) has a suitably constructed edge (5), preferably smooth and rounded to accommodate the glans penis. The intermediate portion (34) of the inner tube (1) is located between the lower portion (33) and the upper portion (35), preferably closer to the upper portion (35). The intermediate portion (34) includes an anti-rotational mechanism (8) that maintains the glans penis in its anatomical position and ensures that the glans penis does not rotate during circumcision procedure. The anti-rotational mechanism (8) is structured as a semi-circular dowel pin protruding from the surface of the intermediate portion (34). The intermediate portion (34) is either partially or completely surrouned by a set of external serrations (7) that serve a purpose of avoiding the clamp from being reused. During the circumcision procedure these serrations would be stained and it is difficult to wash off the stains from the serrations, making the circumcision clamp unhygenic and unable to be reused.

The upper portion (35) of the inner tube (1) includes an opening (11) with an externally threaded portion (9). This opening (11) is for voiding of urine and is either partially or completely surrounded by a set of internal serrations (12) as shown in cross sectional view of FIG. 4 that serve the same purpose as the set of external serrations (7) of the intermediate portion (34).

The second clamping mechanism is a clamp holder (2) that_/holds the glans penis in its anatomical position during the circumcision procedure. The clamp holder (2) as shown in FIG. 5 includes a lower base plate (13), an upper base plate (20) and a spacing structure.

The lower base plate (13) of the clamp holder (2) includes an opening (14) constructed suitably to rest on the protruding circular plate (6) of the inner tube (1). The interior structure of the lower base plate (13) is relatively thin and flat medially and has an outward and downward slope laterally as shown in cross sectional view of FIG. 6. This minimizes thickness of residual necrotic tissue (only 1 mm) once the clamp holder (2) is inserted onto the inner tube (1) and this allows for easy, spontaneous and relatively painless removal of the circumcision clamp once circumcision procedure is complete.

The diameter of the opening (14) of the clamp holder (2) is smaller than that of the protruding circular plate (6) of the inner tube (1) such that during use of the circumcision clamp, there is a small area of contact (25) at site of between the inner tube (1) and the clamp holder (2) to ensure that the width of clamped prepuce is approximately 0.1 mm circumferentially.

Additionally, the diameter of the opening (14) of the clamp holder (2) is such that a gap (26) is present between the inner tube (1) and the clamp holder (2) to ensure that the tissue is not crushed once the circumcision procedure is complete.

The lower base plate (13) of the clamp holder (2) is either partially or completely surrounded by a set of external serrations (17) that serve the same purpose as the set of external serrations (7) of the inner tube (1).

The upper base plate (20) of the clamp holder (2) includes an anti-rotational mechanism (22) to engage the anti-rotational mechanism (8) of the inner tube (1). This anti-rotational mechanism (22) is structured as a recess on the upper base plate (20). The upper base plate (20) has an opening (21) constructed suitably to accomodate the externally threaded portion (9) of the inner tube (1).

The spacing structure between the lower base plate (13) and the upper base plate (20) of the clamp holder (2) is constructed with a set of spacing members (18, 19). The number of spacing members (18, 19) is dependent of the rigidity of material used for constructing the clamp holder (2). The third clamping mechanism is a screw nut (3) that includes an internally threaded portion (23) that is used to engage the externally threaded portion (9) of the inner tube (1). The screw nut (3) as shown in FIG. 7 provides adjustment of the circumcision clamp and prepuce prior to the cutting of prepuce during the circumcision procedure.

The internally threaded portion (23) of the screw nut (3) is either partially or completely surrounded by a set of external serrations (24) that serve the same purpose as the set of external serrations (7) of the inner tube (1). Additionally, these external serrations (24) provide a form of grip during engagement and disengagement of the screw nut (3) onto the externally threaded portion (9) of the inner tube (1). The engagement action maybe a clockwise rotation and where as the disengagement action maybe an anti-clockwise rotation.

Reference is now being made to FIGS. 3, 5 and 7. The semi-circular dowel pin of the anti- rotational mechanism (8) on the inner tube (1) and the recess of the anti-rotational mechanism (22) on the clamp holder (2) work in tandem to maintain the glans penis in its anatomical position during the engagement and disengagement of the screw nut (3) on the externally threaded portion (9) of the inner tube (1).

Reference is now being made to FIG. 8. The circumcision clamp is used as a non- reusable clamp during the circumcision procedure. The circumcision procedure is the order of insertion of clamp, execution of circumcision and removal of clamp. The insertion of clamp is in the order of insertion of the inner tube (1), followed by the clamp holder (2) and finally the screw nut (3). The execution of circumcision is the procedure of removing the prepuce of the penis. The removal of clamp is the reverse order of the insertion procedure. The insertion of the circumcision clamp is decribed in detail as firstly inserting the inner tube (1) onto the glans penis through opening (4) of the lower portion (33) of the inner tube (1). The insertion is done such that the anti-rotational mechanism (8), that is the semi-circular dowel pin protruding from the surface of the intermediate portion (34), points upwards towards patient's face.

This is followed by inserting the clamp holder (2) onto the inner tube (1) through opening (14) of the lower base plate (13) of the clamp holder (2) such that recess of the anti-rotational mechanism (22) on the upper base plate (20) engages into the semi-circular dowel pin of the anti-rotational mechanism (8) on the inner tube (1). This is achieved by pushing the clamp holder (2) down until the externally threaded portion (9) of the inner tube (1) passes through opening (21) of the upper base plate (20) of the clamp holder (2). A small area of contact (25) at site of between the inner tube (1) and clamp holder (2) ensures that the width of clamped prepuce tissue is approximately 0.1 mm circumferentially.

Finally the circumcision clamp is kept in place by engaging the screw nut (3) onto the inner tube (1). This is done by means of a clockwise rotation of the internally threaded portion (23) of the screw nut (3) onto the externally threaded portion (9) of the inner tube (1 ). Adjustment of the screw nut (3) provides adjustment of the circumcision clamp and the prepuce prior to the execution of circumcision.

The execution of circumcision is then carried out by removing a prepuce at gap (26) between the inner tube (1) and clamp holder (2) that is being kept in place by engagement of the screw nut (3). The prepuce is removed by way of cutting the prepuce distal to clamping at the gap (26) between the inner tube (1) and clamp holder (2). Once completed, the clamp is retained for a 7 day period to allow for complete recovery. At any stage of the circumcision procedure, the circumcision clamp may be removed should any complication develops.

The removal of the circumcision clamp begins by disengaging the screw nut (3) by means of an anti-clockwise rotation of the internally threaded portion (23) of the screw nut (3) from the externally threaded portion (9) of the inner tube (1 ). Then, the clamp holder (2) is removed by pulling it away from the inner tube (1) through opening (21) of the upper base plate (20) of the clamp holder (2). Finally the inner tube (1) is spontaneously detached from the penis by soaking the penis and the inner tube (1) in water or by taking a long shower. This detachemnt of the inner tube (1) will therefore be relatively painless. There is no need to use a separate apparatus to detach the circumcision clamp.

Serrations (7, 12, 17, 24) on the inner tube (1), clamp holder (2) and the screw nut (3) of the clamp make it difficult to wash off stains and unhygienic to reuse the clamp. This is to ensure that the circumcision clamp is not reused. These serrations are a set of external serrations (7) on the intermediate portion (34) and a set of internal serrations (12) on the upper portion (35) of the inner tube (1), a set of external serrations (17) on the lower base plate (13) of the clamp holder (2) and a set of external serrations (24) on the internally threaded portion (23) of the screw nut (3).

The circumcision clamp is provided in several sizes. The size represents the diameter of opening (4) of the inner tube (1) is that is catered for the various sizes of the glans penis from infants to adults. The size of the circumcision clamp is marked on the lower portion (33) of the inner tube (1). The determination the size of the clamp that is to be used for the circumcision procedure is either done based upon previous experience gained or by means of a measuring device. The use of the measuring device avoids unnecessary contamination of the circumcision clamp in the event of selecting the right size that is to be used.

Such a measuring device is as shown in FIG. 9. The measuring device (40) is a flat rectangular plate having various circular openings (41) arranged in a row. These circular openings (41) are of progressively increasing diameters representing the various sizes of the glans penis corresponding to the diameter of the opening (4) of the inner tube (1) of the circumcision clamp. The size label (42) of each circular opening (41) is marked above each circular opening (41).

Prior to commencing the circumcision procedure, attempts are made to pass the circular opening (41) over the exposed glans penis. The circular opening (41) that allows the glans penis to pass through it from the tip up to the base of the glans, just comfortably without compressing the glans penis, is selected as the appropriate size of circumcision clamp that is to be used for that particular individual.

Claims

1. A circumcision clamp including a. a first clamping mechanism (1) b. a second clamping mechanism (2) c. a third clamping mechanism (3) characterized in that, the first clamping mechanism (1) is a hollow structure that includes a lower portion (33), an intermediate portion (34) and an upper portion (35), wherein the lower portion (33) includes an opening (4) with a protruding circular plate (6) with a suitably constructed edge (5) to accommodate a glans penis, the intermediate portion (34) includes an anti-rotational mechanism (8) and the upper portion (35) includes an opening (11) with an externally threaded portion (9), the second clamping mechanism (2) that holds a glans penis in anatomical position during circumcision procedure, wherein the second clamping mechanism (2) includes a lower base plate (13), an upper base plate (20) and a spacing structure, wherein the lower base plate (13) includes an opening (14) constructed suitably to rest on the protruding circular plate (6), the upper base plate (20) includes an anti-rotational mechanism (22) to engage the anti-rotational mechanism (8) and an opening (21) constructed suitably to accomodate the externally threaded portion (9), and the third clamping mechanism (3) includes an internally threaded portion (23) to engage the externally threaded portion (9).

2. The circumcision clamp according to claim 1 , wherein the lower portion (33) of the first clamping mechanism (1 ) is a coned shaped structure.

3. The circumcision clamp according to claim 1 , wherein the intermediate portion (34) of the first clamping mechanism (1) is either partially or completely surrounded by a set of external serrations (7).

S 4. The circumcision clamp according to claim 1 , wherein the anti-rotational mechanism

(8) on the intermediate portion (34) of the first clamping mechanism (1) is a position pin.

5. The circumcision clamp according to claim 1 , wherein the upper portion (35) of the first clamping mechanism (1) is either partially or completely surrounded by a set of internal serrations (12).

6. The circumcision clamp according to claim 1 , wherein the spacing structure of the second clamping mechanism (2) is constructed with at least one spacing member (18).

7. The circumcision clamp according to claim 1, wherein the opening (14) of the lower base plate (13) of the second clamping mechanism (2) has a diameter such that a minimal area of contact (25) is present at site between the first clamping mechanism (1) and second clamping mechanism (2) to ensure that the width of clamped prepuce tissue is approximately 0.1 mm circumferentially.

8. The circumcision clamp according to claim 1, wherein the opening (14) of the lower base plate (13) of the second clamping mechanism (2) has a diameter such that a gap (26) is present between the first clamping mechanism (1) and second clamping mechanism (2).

9. The circumcision clamp according to claim 1 , wherein the lower base plate (13) of the second clamping mechanism (2) has an interior structure that is relatively thin and flat medially and has an outward and downward slope laterally.

10. The circumcision clamp according to claim 1, wherein the lower base plate (13) of the second clamping mechanism (2) is either partially or completely surrounded by a set of external serrations (17).

11. The circumcision clamp according to claim 1, wherein the anti-rotational mechanism

(22) on the upper base plate (20) of the second clamping mechanism (2) is a recess.

12. The circumcision clamp according to claim 1 , wherein the internally threaded portion

(23) of the thrid clamping mechanism (3) is either partially or completely surrounded by a set of external serrations (24).

13. The circumcision clamp according to claim 1 , wherein a measuring device (40) is provided to measure the size of the glans penis before the circumcision procedure is conducted.

14. A method of circumcision using a circumcision clamp, wherein the circumcision clamp includes a. a first clamping mechanism (1) b. a second clamping mechanism (2) c. a third clamping mechanism (3) characterized in that, the first clamping mechanism (1) is a hollow structure that includes a lower portion (33), an intermediate portion (34) and an upper portion (35), wherein the lower portion (33) includes an opening (4) with a protruding circular plate (6) with a suitably constructed edge (5) to accommodate a glans penis, the intermediate portion (34) includes an anti-rotational mechanism (8) and the upper portion (35) includes an opening (11) with an externally threaded portion (9), the second clamping mechanism (2) that holds a glans penis in anatomical position during circumcision procedure, wherein the second clamping mechanism (2) includes a lower base plate (13), an upper base plate (20) and a spacing structure, wherein the lower base plate (13) includes an opening (14) constructed suitably to rest on the protruding circular plate (6), the upper base plate (20) includes an anti-rotational mechanism (22) to engage the anti-rotational mechanism (8) and an opening (21) constructed suitably to accomodate the externally threaded portion (9), and the third clamping mechanism (3) includes an internally threaded portion (23) to engage the externally threaded portion (9), wherein the method of circumcision includes

(a) inserting the first clamping mechanism (1) into the glans penis through opening (4) of the lower portion (33) of the first clamping mechanism (1),

(b) inserting the second clamping mechanism (2) onto the first clamping mechanism (1) through opening (14) of the lower base plate (13) of the second clamping mechanism (2) such that the anti-rotational mechanism (22) of the upper base plate (20) engages into the anti-rotational mechanism (8) of the first clamping mechanism (1),

(c) engaging the third clamping mechanism (3) onto the externally threaded portion (9) of the first clamping mechanism (1 ), (d) removing a prepuce at a gap (26) between the first clamping mechanism (1) and second clamping mechanism (2),

(e) disengaging the third clamping mechanism (3), followed by removal of the second clamping mechanism (2) and detachment of first clamping mechanism (1).

15. The method of circumcision according to claim 14, wherein the disengaging of the third clamping mechanism can be done at any time during the circumcision procedure.

16. The method of circumcision according to claim 14, wherein the disengaging the third clamping mechanism is done on the 7^th day calculated from the completion of the circumcision procedure.

17. The method of circumcision according to claim 14, wherein the circumcision clamp is a non-reusable circumcision clamp.

18. The method of circumcision according to claim 14, wherein a measuring device (40) is provided to measure the size of the glans penis before step (a).