The present invention relates to a device for assisting a doctor to perform a vasectomy procedure.

During many surgical procedures, it is necessary for the subject of the operation to be given an anaesthetic. It is common practice to give local anaesthetics for simple surgical procedures. However, with a vasectomy operation, although the actual procedure is very simple, due to the sensitive nature of the area of operation the administering of the anaesthetic requires a steady hand. Conventional methods use syringes with short needles, and careful application by the doctor. There is the risk of inaccurate application of the anaesthetic, and hence often slightly more anaesthetic than is actually required is voluntarily applied to ensure the effectiveness of the anaesthetic.

Once the anaesthetic has been administered, it becomes necessary to identify the two vas deferens, the tubes that carry sperm to the urethra, and then to cut and seal each vas deferens via at least one incision made in the skin of the scrotum. Finally, the incision in the scrotum is closed. The tasks of identifying the two vas deferens, incising the scrotum, cutting and sealing the vas deferens and closing the incision in the scrotum can take as little time as fifteen minutes. However the accuracy of each of the cuts is vitally important to ensure the quick recovery of the patient and to minimise scarring. The accuracy of the cuts can be improved by accurately holding the scrotum and vas deferens in a fixed position.

It is therefore the object of the present invention to provide a vasectomy aid that not only accurately applies a required amount of anaesthetic to the area of operation, but also holds the scrotum and at least one vas deferens in a fixed position.

According to the present invention there is provided a vasectomy aid comprising a clamp for holding both part of a scrotum and at least one vas deferens in position ready for surgery, and a needle arm swingably engageable with the clamp.

The needle arm may be removable from the clamp and advantageously comprises a syringe holding portion for holding at least one syringe. The syringe holding portion may be either incorporated into the needle arm, or could be removable. Alternatively, a needle block arrangement may be substituted for the syringe holding portion.

Preferably, the needle arm is adapted to hold three syringes, at least one of which is removable from the needle arm.

Alternatively, the needle arm is adapted to hold one syringe having three outlets. Preferably the single syringe is removable from the needle arm.

The needle arm may further comprise a spring loaded guard for preventing accidental contamination of needle tips of any syringes positioned within the needle arm.

During use of a preferred embodiment, the needle arm is swung towards the scrotum so that the needles are positioned against the scrotum. The needle arm is then pressed against the scrotum similar in action to a hole punch, thus depressing the spring loaded guard, causing the needle tips to become proud of the guard and to be inserted into the scrotum. The action of pressing the spring loaded guard against the needle arm can be used for simultaneously causing the syringes to apply the anaesthetic. In one such development, upon squeezing the guard against the needle arm, the guard depresses the at least one syringe against a

syringe plunger, thus ejecting the contents of the at least one syringe. However, in a more simple construction, the syringes are depressed manually and simultaneously with the action of depressing the spring loaded guard.

Preferably, the clamp comprises both a base piece and a worktable piece which are pivotably and advantageously removably engage able with each other for instance via engagement holes and corresponding engagement pins. The relative pivoting movement of the base piece and worktable piece is advantageously resisted by a spring.

The worktable piece preferably comprises a protruding working platform about which the scrotum and the at least one vas deferens can be positioned prior to closing the clamp onto the scrotum and vas deferens. To assist this positioning, the clamp preferably features at least one clip retaining means, which, in use, retains at least one clip, the clip being attached to a vas deferens and scrotum. In this way, the vas deferens will have been pre-identified, and accordingly, the positioning and orienting the vas deferens into the clamp. . The clips may be inserted into the clip retaining means so as to hold the vas deferens in position prior to clamping and administering anaesthetic.

The working platform may have two slots into either of which the vas deferens can be positioned, thus enabling both vas deferens to be held in position.

Preferably, the working platform on the worktable piece and two inwardly bent connecting arms on the base piece form jaws of the clamp.

A ratchet locking mechanism may be provided on the clamp for locking the two pieces of the clamp in a desired clamped position.

A vasectomy aid according to the present invention enables an anaesthetic to be administered in a specific position relative to the area of operation, and also provides efficient holding of part of the scrotum and of at least one vas deferens, thus permitting accurate application of anaesthetic and incision of the scrotum and an accurate cutting of the vas deferens.

A preferred embodiment of the invention will now be described with reference to the accompanying drawings in which: Figure 1 is a perspective view of a complete vasectomy aid according to a preferred embodiment of the present invention; Figure 2 is an exploded perspective view of the component parts of the vasectomy aid of Figure 1; Figure 3 is a perspective view of the clamp of the vasectomy aid of Figure 1; Figure 4 shows a needle block arrangement; Figure 5 shows a three way syringe; and Figure 6 shows a working platform having two slots.

Referring to Figures 1, 2 and 3 there is shown a vasectomy aid (1) comprising a base piece (3), a worktable piece (5), and a removable needle arm (9). The base piece (3) and the worktable piece (5) together form a clamp (7) The removable needle arm (9) is approximately shaped like a capital "A" with the two legs (11) of the "A" forming a proximal end of the removable needle arm (9) and the top of the "A" forming a distal end (13). The face of the "A"

shown in Figure 2 will be referred to as the top face, with the underside being the opposite face.

The two legs (11) of the removable needle arm (9) have "C" shaped engagement clips (15) for engaging with corresponding non-circular engaging bars (17) on the worktable piece (5).

The engagement clips (15) are sized to allow the removable needle arm (9) to be engaged with the two engagement pins (17) of the worktable piece (5) only when the two pieces (5,9) are substantially perpendicular to each other. Each piece can then be rotated relative to each other about the common axes (19) of the two engaging bars (17). When the two pieces (5,9) are not substantially perpendicular, the two pieces (5,9) cannot be engaged or separated.

Alternative methods of joining the two pieces (5,9) together could be used. However, the needle arm (9) should be swingably attached, and be either removable, or capable of being swung away from the clamping face side of worktable piece, such as to the underside.

At the distal end (13) of the removable needle arm (9), there is a syringe holding portion (21), comprising a protrusion extending from the top face substantially perpendicularly away from underside of the "A" shape. This protrusion, in the preferred embodiment, comprises three holes (23) each sized to retain a removable syringe (not shown). Alternatively, the syringe holding portion (21) can be adapted to receive a three way syringe of the type shown in Figure 5.

In another alternative, the syringe holding portion (21) can be replaced by a three-way needle block of the type shown in Figure 4. The needle block (80) comprises a block of injection moulded rigid PVC having three parallel bores (81) extending parallel to one side of the block (80). A closed cross bore (82) extending perpendicularly to the parallel bore (81), is connected to the parallel bores (81).

A stainless steel needle (83) is bonded into each of the parallel bores (81) with the pointed ends of the needles (83) protruding beyond the face of the block (80).

Preferably one of the outer needles protrudes further beyond the face, by about 4mm, than the other two needles.

A plasticised PVC tube (84) is solvent bonded into the open end of the cross bore (82) so as to allow anaesthetic liquid to flow from a luer lock adapter (not shown) to the needles.

The needle block (80) may be removably mounted on the needle arm (9) in the same way that the syringe holding portion is.

Referring again to Figures 1 to 3, attached near a distal edge on the underside of the central crossbar (25) of the "A" shape and extending at an acute angle away from the top face and towards the distal end (13) of the removable needle arm (9) there is a spring-loaded guard (27). This guard (27) functions to protect protruding needle tips (29) of any removable syringes located in the holes of the syringe holding portion (21) or in the needle block (80). The guard (27) contains holes (not shown) through which the needle tips (29) can extend when the guard (27) is flattened against the removable needle arm (9). When the vasectomy aid (1) is in use, and the needle tips (29) are required to be inserted into the scrotum, the guard (27) is squeezed against the scrotum by applying a force between the clamp (7) and the removable needle arm (9), thus causing the guard (27) to become flattened against the underside of the removable needle arm (9). This in turn allows the needle tips (29) to protrude beyond the guard (27) through the holes in the guard (27) and into the scrotum for administering anaesthetic.

The base piece (3) comprises a flat substantially rectangular plate (31) with a proximal side (33), a distal

side (35), and two ends (37). As shown in figure 2, the top side of the base piece faces upwards. Two parallel connecting arms (39) extend distally from the ends (37) of the plate (31) substantially perpendicular to the distal side (35) of the plate (31). The ends (41) of each connecting arm (39) are upturned and bent inwards towards each other.

The base piece (3) further optionally comprises a leaf spring (43) attached to the upper side of the middle part of the distal side (35) of the plate (31) and is preferably angled at approximately 45" distally upwards. The leaf spring may be replaced by a coil spring or any other resilient mechanism.

On the proximal side (33) of the plate (31) extending upwardly, there is a first part (45) of a ratchet locking mechanism. Two engaging holes (47) are centrally and co- axially located in the two connecting arms (39).

The worktable piece (5) comprises a flat work surface (48) with a proximal end (49), a distal end (51) and two sides (53). Each side has an engaging hole (55) (one shown). The two holes (53) are aligned and positioned to be engageable with the engaging holes (47) in the base piece (3) by means of two pins (not shown). The proximal ends of each side (33) are cut back to fit between the two legs (11) of the needle arm (9). Adjacent the proximal end (49) of the work surface (48), one on each side (53), are the two engagement pins (17) onto which the "C" shape clips (15) of the removable needle arm (9) can be engaged.

At the central portion of the proximal end (49), a second part (46) of the ratchet locking mechanism is located. The two parts (45,46) of the ratchet locking mechanism are engage able with each other to provide variable locking positions for the clamp (7).

Towards the distal end (51) of the worktable piece (5), there is a holding platform (59) extending upwardly (as shown in all figures) from the flat work surface (48) of the piece (5). The holding platform (59) comprises a distal face (61), a proximal face (63), two sides, a step portion (65) and a top (67). The top preferably has three holes (69) positioned to receive the three needle tips (29) when the needle arm (9) is swung down and squeezed against the scrotum. The proximal face (63) is convexly curved to provide a comfortable surface for the scrotum. The step portion (65) is provided for positioning a vas deferens, once the vas deferens has initially been identified. Upon identifying the vas deferens, surgical clips (not shown) are attached to the vas deferens and scrotum. These clips are adapted to be connected to the vasectomy aid to initially position and orientate the vas deferens in the vasectomy aid. For connecting the clips to the vasectomy, grooves (50) in the worktable piece (5) are provided. However, any clip retaining means such as hooks, holes, or further clips may be provided.

If desired, the top (67) of the holding platform (59) may include two slots, as shown in figure 6. The slots (90) will be useful for further locating one or both of the vas deferens.

The clamp (7), i.e. the base piece (3), the worktable piece (5) and the needle arm (9) may be made of a polycarbonate resin. This would allow ethylene oxide, gamma irradiation or low temperature steam sterilisation to be repeatedly carried out without degrading the material. However, the syringes, the syringe holding portion, and the needle block are preferably made of a rigid PVC compound with needles made of stainless steel preferably bonded to the syringes or needle block with a medical grade cyanoacrylate ester adhesive. In embodiments where the needles are bonded to

the needle block, a plasticised PVC tube is preferably bonded to both the needle block and a luer lock connector.

Such a needle block construction would be capable of sterilisation using ethylene oxide or gamma irradiation techniques.

In use of the vasectomy aid (1), the needle arm (9) is removed and the base piece (3) and worktable piece (5) are pivotably joined together via the aligned engagement holes (55, 47) and two pins to form the clamp (7) (see figure 3).

The scrotum and vas deferens are prepared for surgery, which generally includes shaving, and the application of two clips to the vas deferens either side of the point at which the vas deferens is to be cut, and the clamp (7) is then offered to the scrotum. A vas deferens is positioned on the step portion (65) and held in place by connecting the clips to the grooves (50), whilst the scrotum is placed over the top of the holding platform (59) and down to the proximal face (63) of the holding platform (59). The clamp (7) is then squeezed shut and held shut by the interaction of the two parts (45, 46) of the ratchet locking mechanism. The scrotum and vas deferens are held in place by the inwardly bent ends (41) of the connecting arms (39) of the base piece (3) which contact with the scrotum, thus causing the scrotum to be located against the holding platform (59). Once the clamp (7) has been attached to the scrotum and the vas deferens is located on the step portion (65), the needle arm (9) can then be attached to the clamp (7). The needle arm (9) is then swung round so that the needle tips (29) are proximal to the scrotum. The needle arm (9) and clamp (7) are then squeezed together to administer the anaesthetic as previously described, and the needle arm (9) can then be removed from the clamp (7). The scrotum and vas deferens are now ready for the vasectomy operation itself. The worktable piece (5) provides a suitable surface for the surgeon to work on.

It will of course be understood that the present invention has been described purely by way of example, and modifications in detail can be made within the scope of the invention.