OA19353A - Circumcision device - Google Patents

Abstract

A circumcision device is provided by the present invention. The device comprises two jaws configured to crush a foreskin between them along a crush region transverse to a foreskin and transverse to a general direction in which a penis being circumcised extends. The jaws are movable between an open inoperative position and a closed operative position in which a clamping and crushing force may be exerted to promote hemostasis within the crush region. The device includes a cutting assembly capable of traversing and severing a crushed foreskin within or adjacent the crush region. The invention extends to a glans penis protector comprising a handle separable from a transverse glans penis engaging cover so that the handle can be separated from the glans penis engaging cover during a circumcision procedure

Description

It should be mentioned at the outset that ail the components of the device and the glans pénis protector of this invention other than the blade which will generally be made of surgical steel and the connecting lever which will generally be made from sheet métal can, although not necessarily, be made as injection moulded plastic parts designed and made according to requirements.

In the embodiment of the invention illustrated in the drawings, a circumcision device comprises two jaws (1,2) configured to crush a foreskin between them along an elongated crush région that is transverse to a foreskin (3) and transverse to a general direction in which a pénis (4) (see Figure 5) being circumcised extends. The jaws (1,2) are movable about a hinged connection at one end région (5) thereof between a first open inoperative position illustrated in Figures 1 to 3 and a closed operative position in which a clamping and crushing force is exerted on a foreskin positioned between the jaws (1, 2) to promote hemostasis within the elongated crush région as illustrated in Figure 6.

The first jaw (1) with which a cutting assembly (6) is associated is in the form of ajaw assembly composed of an arm (7) supporting a carrier (8) that has attached to it a fiat surgical blade (9) (see Figure j). The blade (9) is guided for movement in its own plane between a guide surface (11) ofthe arm (7) and a parallel guide surface of an insert (12) received within the arm. A cutting edge of the blade (9), as shown in Figure 7, co-operates in the closed operative position with a crushing face (13) of the second jaw (2) within the elongated crush région such that the crushing face (13) serves as a cutting block for the blade (9).

The carrier (8) has, in this embodiment of the invention, a recess accommodating an outer edge of the arm (7) with two inwardly directed lips (14) located in grooves (15) extending along the length ofthe arm (7) to confine movement of the carrier (8) from a first end région ofthe arm to a second end région of the arm. A releasable hinged stop (16) maintains the carrier in a position corresponding to the first open inoperative position of the jaws (l, 2). The carrier (8) also has a catch component (17) in co-operating relationship with a complimentary co-operating catch formation (18) on the insert so that the carrier (8) becomes irreversibly locked in its terminal position at the second end région of the jaw assembly following a cutting action. This effectively prevents attempts at using the device for a subséquent circumcision, resulting in “use-once” functionality.

A mechanism interconnects the jaws (1,2) such that they are movable between their first open inoperative position in which one end of a gap (21) between the jaws is open to allow for the latéral introduction of a transverse foreskin to move along the jaws to a central région thereof that is clearly indicated by suitable markers (22) and the closed operative position. The mechanism includes the hinged interconnection that is provided at a first end région (5) of the jaws (1,2) wherein the hinged connection is configured so that it cannot be disengaged when the jaws (1, 2) are in their closed operative positions or second inoperative positions as described below.

As regards the second ends of the jaws, they are interconnected by a lever assembly that includes an opeiating lever (25) pivotally attached to a connecting lever (26) at one end and pivotally connected at an opposite end to the second end of one jaw, the first jaw (1) in this instance, with the operating lever having co-axial pivot lugs (27) that are receivable in co-operating receiving formations in the form of apertures (28) associated with spaced flanges of the second jaw (2). The arrangement is such that the operating lever (25) and connecting lever (26) can be used, when the pivot lugs (27) are engaged in their co-operating apertures (28), to obstruct a latéral opening to the gap between the second ends of the two jaws (1, 2) to prevent the subséquent introduction of a foreskin transversely between the jaws. The lever assembly is configured to lock the jaws (1, 2) in the closed operative position in releasable manner by means of an over19353

ΙΟ centre locking mechanism as will be apparent from Figure 6.

The pivot lugs (27) are receivable in the co-operating receiving formations in the form of apertures (28) associated with the second jaw in a substantially non-releasable manner in order to obscure and deter, or render substantially impossible, a second or subséquent use of the device. By so doing, a second open inoperative position is provided in which the connecting lever and the operating lever together obscure the entrance to the gap between the jaws (1, 2) in their released positions following a circumcision in a first use and substantially prevent the transverse introduction of a foreskin to a position between the jaws (1,2).

Introduction of the pivot lugs is achieved in this instance by providing bevelled ends (31) (see Figure 10) to the pivot lugs that may be forced into a space between two spaced flanges (32) of the second jaw (2). The relevant région of the operating lever (25) may be bifurcated, as indicated by numéral (33), so that the natural “give” in the plastics materials allows the pivot lugs to be urged into position between the two spaced flanges and to snap into their final positions as illustrated in Figure 10. The arrangement is such that withdrawal of the lugs is resisted so as to prevent séparation of the operating lever from the second jaw.

The jaws (1,2) are thus interconnected at both ends to exert a crushing force on a foreskin within the elongated crush région when the jaws are in their closed operative positions.

The cutting assembly is of course movable from one end région (the first end région) of the jaws towards an opposite end région (the second end région) thereof relative to the elongated crush région so as to be capable of traversing and severing a crushed foreskin within the elongated crush région.

Turning now to the second aspect of the invention, a glans pénis protector for assisting in the avoidance of damage to a glans pénis during a surgical circumcision procedure is particularly illustrated in Figures 4, 5 and 11 to 15 and comprises a handle (41) having a proximal operating end région (42) and a transverse generally dise shaped glans pénis engaging cover (43) at its distal end. The attachment of the handle (41) to the glans pénis engaging cover (43) is capable of being parted so that the handle can be separated from the glans pénis engaging cover during a circumcision procedure.

H

In this embodiment of the second aspect of the invention the glans pénis protector is made of injection moulded plastics material and is formed intégral with the glans pénis engaging cover intégral with the handle. The attachment of the handle to a proximal surface (44) of the glans pénis engaging cover (43) is by way of a pair of laterally spaced necks (45) located immediately adjacent the bottom of spaced in recesses (46) the proximal surface so that the necks can break off below the proximal surface (44). The glans pénis engaging cover (43) is contoured in a direction transverse to the handle so as to co-operate with a distal end région of a glans pénis (47) in use (see Figure 5). The handle is generally fiat with one or more apertures (48) through it and with a width of the handle being orientated such that a distal end région thereof can be accommodated in a narrow gap between two crushing jaws of a circumcision device in the first open inoperative position described above.

The functionality of the protector may be enhanced by providing an axially extending probe (49) at the proximal end of the handle with the probe having a rounded end (51 ) for use in ensuring that the main function of the probe of the glans protector is to release adhesions safely. Normally a straight forceps that would typically be reusable is used to do this. This has the danger that it may be placed accidentally in the urethra. Adhesions are normal in infants and young children, where the foreskin has not yet been retracted. The release needs to happen before the circumcision.

Steel forceps can cause penetrating injury to the glans, the mucosa, and can accidentally be inserted into the urethra which can tear. The probe has sufficient length to reach the corona at the end of the glans. The design of the glans protector and probe as a single unit, has the benefit of safely releasing the adhesions, protecting the glans and reducing the chance of accidentai insertion into the urethra and still further complying with the single use requirement.

A method of carrying out a circumcision of a foreskin of a patient using the circumcision device and a glans pénis protector as described above thus comprises removal of any adhesions between the glans and the foreskin using the probe (49) on the back of the glans protector, and covering a glans pénis of a patient with a glans pénis engaging cover of a glans pénis protector as described above with the handle extending generally away from the pénis. The required portion of the foreskin (3) of the patient is located over the handle (41) and the foreskin (3) and handle (41) are moved transversely through an opening between corresponding ends of the jaws (1, 2) of a circumcision device as described above with the glans pénis engaging cover (43) immediately ¹² adjacent to the jaws (1, 2) and the handle (41) passing between the jaws (1, 2). The handle (41) can then be aligned with the markers (22). At that stage the handle (41) is broken away from the glans pénis engaging cover (43) to leave it on the side of the jaws opposite that on which the required portion of the foreskin to be removed is located.

The connecting lever (26) and operating lever (25) are moved into position to engage the pivot lugs (27) on the operating lever (25) with the co-operating receiving formations in the associated jaw. The mechanism is then operated to move the jaws (1,2) from their first open inoperative position to their closed operative position in order to crush the foreskin in an elongated crush 10 région between the jaws (1,2) and that the crushed condition is allowed to persist for a period of time that is typically of the order of 5 minutes to promote hemostasis and a condition favourable to the severing of the foreskin by means of the cutting assembly.

The releasable hinged stop (16) is then disengaged and the carrier (8) moved along the arm (7) to 15 cause the blade (9) to sever the foreskin by co-operation with the crushing face of the other jaw.

The face of the other jaw thereby acts as a cutting block for the blade. The cutting assembly is thus moved from its initial position in one end région of the arm (7) and jaws (1, 2) to an opposite end région to effect severing ofthe foreskin crushed between the jaws (1,2). At the end of its travel along the arm (7) the carrier (8) becomes locked in its terminal position by virtue of 20 the catch component (17) moving into co-operating relationship with the complimentary cooperating catch formation (18) on the arm so that the carrier (8) becomes irreversibly locked in its terminal position as described above.

Release ofthe mechanism to the second open inoperative position is then carried out so that the 25 jaws (1, 2) move apart sufficiently to permit withdrawal of the attached foreskin from the circumcision device. The glans pénis engaging cover can then be removed from the pénis.

Numerous variations to the embodiments ofthe two aspects ofthe invention described above are possible within the scope in the invention. Indeed the glans pénis protector need not be used at 30 ail as the circumcision device may be used on its own. The glans pénis protector may also be used on its own, and in particular in combination with existing circumcision devices where its functionality m protecting the glans pénis during a eut of foreskin performed by a blade may be particularly valuable. Devices such as, for example, a Mogen clamp or Mogen clamp-type devices which include a pair of opposing jaws usable to clamp a foreskin to be severed therebetween so as to promote hemostasis as is known in the art. However, it will be appreciated that it may be used with any device or instrument that crushes a patient’s foreskin, including a classical forceps guided circumcision. During use of any such device, the glans pénis protector may reduce the risk of the head of the glans being crushed or eut by protecting the head and 5 uréthral opening of the pénis. The gland pénis protector may also be used with the Gomco clamp, Accucirc, any tissue forceps (whether serrated, toothed, fiat or smooth) or the like which in use ciushes the foreskin and/or mucosa of a patient and/or release adhesions prior to performing the required surgical procedure.

Devices such as a Gomco clamp, Accucirc, tissue forceps or any similar or related device may also be used with the glans pénis protector, where it may shield the glans pénis from accidentai interaction with a blade performing a eut of the foreskin. While use of the glans pénis protector separately will not provide a single use circumcision device, it will provide a single-use glans pénis protecting device if the handle is severed from the engaging cover as described above 15 during use.

Use of the glans pénis protector together with other a known Morgen clamp-type circumcision device may therefore involve the release of adhesions to a glans pénis of a patient as may be required, covering the glans pénis with the glans pénis engaging cover of the glans pénis 20 protector, locating a portion of the foreskin of the patient to be severed over the handle of the glans pénis protector, moving the foreskin and glans pénis protector transversely through an opening between corresponding ends of jaws of the Morgen clamp-type circumcision device, with the glans pénis engaging cover immediately adjacent to the jaws on a proximal side thereof and the handle passing between the jaws, and parting the handle from the glans pénis engaging 25 cover to leave it on the proximal side of the jaws opposite said required portion ofthe foreskin to be severed. The jaws of the Morgen clamp-type circumcision device may then be closed as normal so that the foreskin of the patient is crushed therebetween. The device may further be used as normal, by for example allowing the crushed foreskin to remain in that condition for a time period selected to promote hemostasis. The foreskin may then be eut using the known 30 method for that device, for example by a normal scalpel in a transverse direction across the foreskin. The jaws may then be opened as known to permit withdrawal ofthe attached foreskin from the circumcision device. The glans pénis engaging cover may then be removed and discarded.

It will be appreciated that the glans pénis protector may be produced in a number of different sizes to accommodate a variety of glans pénis sizes. This may at least partially allow for the device to be used for different âge groups.

In use with other circumcision devices that are not Morgen clamp-type devices, it will be apparent that the procedure will be different, as required for the spécifie type of device.

The circumcision device provided by this invention has many features that are considered to be advantageous in that it may be configured as a single use device and does not require a longduration on the body

The device may be used to eliminate the use of separate sharp objects such as a scalpel and thereby protect patients and medical staff from risks of accidentai wounds with the possibility of exposure to blood and infection.

The device may be designed to be inexpensive to manufacture.

Throughout the spécification and claims unless the contents requires otherwise the word ‘comprise’ or variations such as ‘comprises’ or ‘comprising’ will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

Claims (11)

1. L A circumcision device comprising two jaws configured to crush a foreskin between them along an elongated crush région that is transverse to a foreskin and transverse to a general direction in which a pénis being circumcised extends, the jaws being movable between a first open inoperative position and a closed operative position in which a clamping and crushing force is in use exerted on a foreskin positioned between the jaws to promote hemostasis within the elongated crush région, a mechanism interconnecting the jaws such that they are movable between the first open inoperative position in which one end of a gap between the jaws is open to allow for introduction of a transverse foreskin to move along the jaws to a central région thereof and the closed operative position in which the mechanism interconnects the jaws at both ends thereof and the jaws exert, in use, a crushing force on foreskin within the elongated crush région, the circumcision device being characterized in that it includes a cutting assembly movable from one end région of the jaws towards an opposite end région thereof relative to the elongated crush région so as to be capable of traversing and severing a crushed foreskin within or adjacent the elongated crush région and wherein the cutting assembly includes a carrier movable along a length of one of the jaws from a first end région thereof to a second end région thereof.
2. 2. The circumcision device as claimed in claim l, wherein the carrier includes a releasable stop maintaining it in a position corresponding to the first open inoperative position of the jaws.
3. 3. The circumcision device as claimed in claim l or claim 2 wherein the jaw with which the cutting assembly is associated is in the form of a jaw assembly composed of an arm supporting the carrier and a fiat surgical blade attached to the carrier with the blade being guided for movement between a guide surface of the arm and a guide surface of an insert leceived within the arm with a cutting edge of the blade co-operating in the closed opeiative position with a face of the other jaw within the elongated crush région so that the face serves as a cutting block for the blade.
4. 4. The circumcision device as claimed in any one of the preceding claims wherein the carrier has a catch component in co-operating relationship with a complimentary co-

   I6 operating catch formation on an associated jaw assembly so that the carrier becomes irreversibly locked in its terminal position at the second end région of the jaws following a cutting action to thereby inhibit attempts at using the device for a subséquent circumcision.
5. 5. The circumcision device as claimed in any one of the preceding claims wherein the mechanism includes formations providing a hinged interconnection at a first end of the jaws wherein the hinged connection cannot be disengaged when the jaws are in their first or second inoperative positions or their closed operative positions.
6. 6. The circumcision device as claimed in claim 5 wherein second ends of the jaws are interconnected by a lever assembly including an operating lever and a pivotally attached connecting lever connected at an opposite end to the second end of one jaw with the operating lever having pivot lugs that are receivable in co-operating receiving formations associated with the other jaw so that the operating lever and connecting lever can be used by engaging the pivot lugs in the co-operating receiving formations associated with the other jaw to close an opening between the ends of the two jaws after introduction of a foreskin transversely between the jaws and to move the jaws together into the closed operative position.

   7· The circumcision device as claimed in claim 6 wherein the levers are configured to lock the jaws in their closed operative positions in releasable manner by means of an overcentre locking mechanism.
7. 8. The circumcision device as claimed in claim 6 or 7 wherein the pivot lugs are receivable in the co-operating receiving formations associated with the other jaw in a non-releasable manner in order to deter a second or subséquent use of the device by providing a second open inopeiative position in which the connecting lever and the operating lever substantially inhibit the introduction of a foreskin to a position between the jaws.

   λ A glans pénis protector comprising a handle having a distal operating end région and a transverse glans pénis engaging cover at its proximal end wherein an attachment of the handle to the glans pénis engaging cover is capable of being parted so that the handle can be separated from the glans pénis engaging cover during a circumcision procedure and wherein the attachment of the handle to a distal surface of the glans pénis engaging cover is located in a recess in the distal surface.
8. 10. The glans pénis protector as claimed in claim 9 wherein the attachment ofthe handle to the glans pénis engaging cover is formed intégral with the glans pénis protector and the attachment of the handle to the glans pénis engaging cover is frangible.
9. 11. The glans pénis protector as claimed in claim 9 or claim 10 wherein the attachment ofthe handle to a distal surface of the glans pénis engaging cover is located in spaced recesses in the distal surface by way of a pair of spaced necks immediately adjacent the distal surface.
10. 12. The glans pénis protector as claimed in any one of claims 9 to 11 wherein the handle is generally fiat and with a width of the handle being orientated such that a proximal end région thereof can be temporarily accommodated in an narrow gap between two crushing jaws of a circumcision device having a pair of jaws between which a foreskin may be crushed adjacent a glans pénis preparatory to circumcision.
11. 13. The glans pénis protector as claimed in any one of claims 9 to 12 wherein an axially extending probe is provided at the proximal end of the handle with the probe having a rounded end for use in releasing adhesions to the glans pénis.