Positioning Device for a Surgical Instrument
The invention relates to a positioning device for a surgical instrument -
Frequently in surgical operations, the position of the surgical instrument used, and in particular of- its parts which are essential for the success of the surgery, is not precisely known. For example, a tip of a needle is not visible while the needle is being guided through tissue. However, in the case of instruments which serve to guide needles, exact guidance through the tissue is of great importance and an incorrect positioning of the needle can result in considerable damage to the tissue.
An example of a surgical process in which such a problem can arise is a process for the treatment of female stress incontinence in which a surgical instrument is used which is described in WO 96/06567 and in WO 97/13465. With this instrument, a strong bent surgical needle is secured to each of the two ends of a polypropylene tape, and guided using a detachable grip. The two needles are moved on opposite sides of the urethra of a patient via the vagina along the rear of the pubic bone to the outside of the abdominal wall. The tape comes to lie in a bend below the urethra. The two ends of the tape are pulled through the abdominal wall and cut off. In this method, the exact guidance of the needle by means of the respective grip is of great importance in order not to damage the vessels deep in the tissue which are hidden from view. Incorrect guidance of the needle can lead to injuries to the patient's large blood vessels which, although rare, are
dangerous, sometimes life-threatening and which requiϊ emergency treatment.
Although, in principle, it is possible to follow th current position of the surgical instrument used, i.e. i the above example the position of the needle tip, usin an imaging process (e.g. an X-ray process), in practice this is frequently associated with considerable expense.
The object of the invention is to provide a possibilit for determining the current position of a surgica instrument which is reliable and cheap and which does nc significantly change an established operationa procedure.
This object is achieved by a positioning device for surgical instrument with the features of claim 1 Advantageous versions of the invention emerge from th dependent claims .
The positioning device according to the invention for surgical instrument is attachable to an area of th surgical instrument which is located outside the tissυ of a patient when using the surgical instrument. It i also conceivable that the positioning device i permanently attached in such an area of the surgica instrument, e.g. if the positioning device i manufactured in one piece with the surgical instrument o parts of the surgical instrument. The positioning devic has a bearing mark and a bearing opening provided at distance from the bearing mark, through which the bearin mark is visible from the perspective of the operator whe the surgical instrument is correctly oriented.
For example, the positioning device can be adapted fc attachment to a grip which is provided for handling bent surgical needle, e.g. for the method outlined abo\ of treating stress incontinence. The positioning devic is adjusted at the grip such that the operator can deduc the correct rotational position and thus the position c the tip of the large bent surgical needle when he see the bearing mark through the bearing opening from hi perspective. If the grip is held incorrectly, the bearir mark is only partly visible, or no longer visible at all Through the invention, the operator is easily enable e.g. to position the needle in controlled and correc manner and to guide it in controlled manner. A latera ■"sliding" of the needle into the vicinity of larger bloc vessels can hereby be avoided.
As the positioning device according to the invention i preferably conceived as an add-on apparatus for a already existing surgical instrument, the positionin device can be used with already existing surgica instruments. Such instruments can therefore b supplemented with the positioning device, the positionin device being matched to the relevant surgical instrumen where appropriate. It is also conceivable to use th positioning device only if required; thus, e.g., a ver experienced operator can dispense with it.
In a preferred version, the positioning device accordin to the invention has a basic body, which has a slot th opening of which is arranged as a bearing opening at on external surface of the basic body and the base of whic lying opposite the bearing opening at a distance has bearing mark. The slot is preferably designed as rectilinear longitudinal slot. The cross-sectional shap
of the slot can broaden towards the base. Thus the slo can for example be shaped like a dovetailed notch. Wit such a design, the operator can easily recognize th bearing mark on the base of the slot through the bearin opening when he is holding the positioning device, an thus the surgical instrument correctly. He knows then e.g. ,. exactly in which direction the bent surgical needl taken as an example extends at that moment and ca immediately decide, from the side to which the bearin mark is moving from the bearing opening when he is no holding the instrument correctly, the direction an extent of a necessary correction. The handling of th positioning device is thus simple and exact.
Preferably, an external side of the basic body of th positioning device is matched to the shape of th surgical instrument provided for the use of th positioning device, e.g. by forming a curve. The basi body can be lockable to the surgical instrument provide for the use of the positioning device. With this design the securing of the positioning device to the surgica instrument is particularly easy and requires n additional means. The basic body preferably has a injection-moulded part, which is very cheap.
Various possibilities are conceivable for the design o the bearing mark. For example, the bearing mark can hav a coloured marking. The bearing mark is particularl noticeable when it contains a fluorescent paint. Anothe possibility for the bearing mark- is a light source, e.g a small fluorescent tube which is operated for example b a button cell housed in the positioning device or th surgical instrument.
In the following, the invention is explained in more detail using embodiments. The drawings show in
Figure 1 a schematic perspective view which shows how a positioning device according to the invention is fitted onto a grip for the guidance of a surgical needle,
Figure 2 a perspective view of a version of the positioning device according to the invention from the perspective of the operator when the surgical instrument with which the positioning device is used is incorrectly oriented,
Figure 3 a perspective view of the positioning device from Figure 2 from the perspective of the operator when the surgical instrument is correctly oriented and
Figure 4 a perspective view (similar to Figure 3) of a further version of the positioning device according to the invention.
In Figure 1, it is shown in schematic perspective view how a positioning device 1 is attached to a surgical instrument. In the embodiment, the surgical instrument has a grip 2 at the distal end 3 of which is fitted the shaft of a large bent surgical needle 4, which is provided with a tip 5. At its proximal end, the grip 2 has ■ a broader section 6; a knob 8 is located there. By turning the knob 8, a lock inside the grip 2 is released so that the needle 4 can be removed from the grip 2.
In the embodiment, the bent surgical needle 4 serves in the surgical technique mentioned at the outset to pull an implant tape, not shown in Figure 1, which is secured to the needle 4 in the proximal area of the shaft. As the needle 4 is of a considerable size, its use is made much easier by the grip 2. On guiding the needle 4 with the grip 2 , the tip 5 is initially located inside the tissue. The operator must be careful to orient the needle 4 correctly. The orientation of the broader section 6 of the grip 2 gives the operator an indication of the position of the tip 5 when he guides the needle 4 through the tissue. A considerably better assessment of the orientation of the needle 4 can be achieved, however, using the positioning device 1, as explained further below. When the tip 5 has completely pierced the tissue, the operator can loosen the locking of the needle 4 at the grip 2 by turning the knob 8 and remove the grip 2 so that the needle 4 can be pulled completely through the tissue with the tape secured to it.
The positioning device 1 is locked to the grip 2 in the embodiment, as indicated by the two arrows in Figure 1.
In Figure 2, the positioning device 1 is shown in perspective view. The positioning device 1 has a basic body 10 with a longitudinal slot 12 which starts from an external surface 14 of the basic body 10. The opening of the slot 12 on the external surface 14 is called bearing opening 16. The slot 12 extends to a base 18 into the inside of the basic body 10. The . width of the base 18 is greater than that of the bearing opening 16 so that the slot 12 is constructed like a dovetail in its cross- sectional shape. In the embodiment, the basic body 10 consists of an injection-moulded plastics part.
The base 18 has a bearing mark 20, which in the embodiment, is a rectilinear coloured strip running parallel to the bearing opening 16. The width of the coloured strip is less than that of the base 18.
In a . variant of this version, additional differently- coloured strips run parallel to the coloured strip.
The external face 22 opposite the bent external surface 14 of the basic body 10 is matched in its shape to the external side of the grip 2. The positioning device 1 can be secured to the grip 2 using lugs, which are not shown in the Figures. In principle, it is possible that only one single position is provided for securing the positioning device 1 to the grip 2. However, it is also conceivable to match the positioning device 1 and the grip 2 relative to each other such that, e.g., the positioning device 1 can be rotated on the grip 2. In the latter case, the operator has the possibility of adjusting the positioning device 1 into what is for him an optimum position. Means of safeguarding against unintentional movement or rotation of the positioning device 1 should be provided, e.g. in the form of sufficient frictional forces.
In Figure 2, the positioning device 1 is shown from a perspective of the operator, in which the grip 2 and thus the surgical needle 4 with the tip 5 are not optimally oriented. The operator can easily recognize this because he cannot see the complete length of the bearing mark 20 through the bearing opening 16. If the bearing mark 20 has strips of different colours (e.g. using fluorescent paint) , as outlined above, the operator can immedia-tely
determine, from the colour effect which he obtains from the bearing mark 20, the direction in which he must change the orientation of the grip 2 in order to correct the position of the needle 4.
When the grip 2 is correctly oriented with the positioning device 1, the operator from his perspective sees the full length of the bearing mark 20 through the bearing opening 16 of the slot 12. This is shown in Figure 3.
Figure 4 shows a further version of the positioning device, here numbered 1' . The positioning device 1' is designed similarly to the positioning device 1, for which reason the same reference numbers are used for the same parts.
In the positioning device 1' , a fluorescent tube, which extends along the base of the slot 12 and parallel to and at a distance from the bearing opening 16, serves as bearing mark 20 ' . The fluorescent tube 20' is operated via a button cell, not shown in Figure 4, housed inside the basic body 10. The fluorescent tube 20' can be very easily recognized when it is turned on, for which reason the positioning device 1 ' is particularly pleasant to handle.