WO2004002334A1

WO2004002334A1 - Surgical instrument

Info

Publication number: WO2004002334A1
Application number: PCT/EP2003/006779
Authority: WO
Inventors: Reinhard Juraschek; Axel Arnaud
Original assignee: Ethicon Gmbh
Priority date: 2002-06-28
Filing date: 2003-06-26
Publication date: 2004-01-08
Also published as: DE10229137A1; AU2003249885A1

Abstract

A surgical instrument (20), which in particular is suitable for the treatment of cysts, has a suction head (26) which has at least one suction opening (44) and is set up to fit tightly to bodily tissue. The suction opening (44) can be connected to a negative-pressure source via a negative-pressure duct (40).

Description

Surcrical instrument

The invention relates to a surgical instrument, in particular for the treatment of cysts .

When surgically removing a cyst, e.g. a cyst of the ovaries, there is in principle the risk that the cyst will be inadvertently opened during the surgery. This is problematic because cysts can potentially be malignant. In particular, laparoscopic procedures are not uncritical when using conventional endoscopic gripping or cutting instruments.

The object of the invention is to provide a surgical instrument which in particular simplifies and makes safer the treatment and removal of a cyst and which in principle is also suitable for endoscopic procedures .

This object is achieved by a surgical instrument with the features of claim 1. Advantageous designs of the invention result from the dependent claims .

The surgical instrument according to the invention, which is suitable in particular for the treatment of cysts, has a suction head which has at least one suction opening and is set up to fit tightly to bodily tissue. The suction opening can be connected to a negative-pressure source by a negative-pressure duct.

By means of the suction head of this surgical instrument, a cyst can be secured by suction. The shape of the suction head, which is set up to fit tightly to bodily tissue, ensures that the cyst is held securely. By means of the negative pressure which can preferably also be varied or reduced to atmospheric pressure (ventilation) , so that the cyst is released again, the cyst can be treated carefully and safely, e.g. during preparation and removal from the patient' s body. The risk of unintentionally opening the cyst in the process is considerably reduced in comparison with the use of a conventional gripping instrument. The cyst can be secured by suction, released again if necessary (e.g. for positioning) and secured again by suction and, e.g., it can be inserted into a bag by means of which it can be remo- ved from the inside of the patient' s body via a trocar.

The surgical instrument can be designed as an endoscopic or laparoscopic instrument (e.g. for the use of cannulas with an external diameter of 12 mm or 18 mm) , but also for open surgery. The removal of cysts has already been mentioned as an area of application. The surgical instrument can, however, also be useful in other surgeries, e.g. in the laparoscopic removal of the gall bladder.

The suction head is preferably arranged at the distal end of a shaft. A handle with operating elements, e.g. to control the negative pressure, can be provided in the proximal end region of the shaft.

In a preferred version of the invention the suction head widens in distal direction. The suction head can be flexible and/or foldable and in a compressed state can have a maximum diameter which at most is as great as the diameter in the distal end region of the shaft. The suction head is preferably self-expan- dable from the compressed state into its operating state. These properties can be achieved e.g. with a suction head made from elastic material (e.g. silicone) , which has the further advantage that such a material as a rule fits tightly without any problems to bodily tissue. Such designs enable the surgical instru- ment to be inserted into the inside of a patient' s body via a cannula, the internal diameter of which is adapted to the shaft diameter of the surgical instrument. The suction head then assumes a shape the width or diameter of which is greater than the shaft diameter. This enables the surgical instrument also to be used to treat cysts which are larger than the shaft diameter. Particularly suitable shapes of the suction head are frustum- or cup-shaped.

While the surgical instrument according to the invention can be designed as a pure suction instrument for gripping bodily tis- sue, e.g. a cyst, and for moving these, in a preferred version the shaft has at least one operating channel which has an opening at the suction head.

The operating channel is set up to receive a surgical tool, e.g. a hollow needle or a morcellator. Thus e.g. a small operating channel (typical internal diameter 3 mm) is sufficient for the use of a thin hollow needle suitable for the sucking up of fluids. Such fluids are present in most benign cysts of the ovaries . On the other hand, a larger needle or a morcellator is necessary to suck up viscous contents (e.g. in the case of der- oid cysts) , which is possible with a larger operating channel (typical internal diameter 10 mm) .

The surgical tool received by the operating channel can prefera- bly be moved in the longitudinal direction of the operating channel. This makes possible operating techniques in which, e.g., a cyst is initially fixed by means of the suction head and then punctured by advancing a hollow needle and drained via the hollow needle. Even if fluid losses should occur around the insertion point of the hollow needle, the fluid cannot enter the lumen because the suction head fits tightly to the cyst tissue.

After the sucking up of the fluid or viscous content of the cyst by means of a hollow needle, the remains of the cyst can as a rule be directly sucked up by means of the suction head and thus removed, which is advantageous. The operating channel preferably has, in the region of the surgical instrument opposite the ope- ning relative to the longitudinal direction of the shaft, an inlet which is preferably provided with a seal.

In an advantageous design of the invention, there is provided at the suction head just one suction opening which is identical to the opening of the operating channel and preferably extends over at least 50% of the cross-section area, measured at the distal end of the suction head, of the suction head. The same pressure conditions preferably prevail in the operating channel and the negative-pressure duct, the negative-pressure duct preferably being formed by the internal space of the shaft and the operating channel being defined therein by a guide device. This guide device facilitates the insertion of the surgical tool and ensures a defined positioning of the surgical tool inside the ope- ning at the suction head. It should not limit the free cross- section of the shaft too much, in order that the suction action is not impaired and it is possible, e.g., to suck up the largely drained remains of a cyst via the relatively large opening at the suction head. The structure of the surgical instrument is very simple and economical in the case of such a design.

In principle, however, the operating channel can also be separated from the negative-pressure duct so that the same negative pressure does not automatically prevail in the operating channel as in the negative-pressure duct. Versions in which the operating channel can be supplied with negative pressure separately from the negative-pressure duct or the suction opening allocated to the negative-pressure duct are also conceivable.

In principle, there can also be several suction openings to which, e.g., a common or else separate negative-pressure ducts are allocated.

The surgical instrument preferably has a control device which is set up to control the negative pressure in the negative-pressure duct. The control device can be set up to either connect the negative-pressure duct to the negative-pressure source or to ventilate it (preferably using a filter) . The control device preferably has a valve control which, in an advantageous design, can be operated via a handle.

Thus e.g. two valves can be provided, each of which is closed by a spring when in the resting state. One of these valves is incorporated into the negative-pressure duct, while the other is arranged in a ventilation pipe for the negative-pressure duct. The operating element which can be reached via the handle has a neutral middle position in which both valves are closed. If the operating element is moved in one direction, the first valve is opened, while the second remains closed, and if the operating element is moved in the opposite direction, the first valve closes and the second valve opens. This allows a simple handling of the surgical instrument, wherein the negative pressure can be comfortably altered at the least at one suction opening, e.g. to manipulate a cyst.

The negative-pressure source is preferably an external apparatus which is not part of the surgical instrument. It can be coupled to the surgical instrument, e.g., via a hose.

In a further preferred version of the invention, the surgical instrument has a bag which can be present in a folded state and in an unfolded state. In the folded state the bag can be transported to the suction head via a transport passage, while the suction head can be received by the bag via the opening at the bag edge when the bag is unfolded. This version can be provided in variants of the surgical instrument with an operating channel and without an operating channel .

The bag is an additional safety feature because, e.g., it allows a freely prepared cyst to be enclosed or captured. If there is an operating channel and the cyst, as mentioned above, is to be drained by a hollow needle and its remains sucked up via the suction head, the cyst must initially be punctured by the hollow needle. As the suction force exerted by the suction head cannot be greater than the product of the pressure difference produced by suction and the cross-section area of the cyst which is secu- red by suction, it is advantageous in particular in the case of hard cysts if the cyst is also held by the bag during piercing. Furthermore, the bag ensures the drawing in of the remains of the cyst if the remains of the cyst are not small enough to be able to be completely sucked up by the suction head. Finally, the bag represents a further safety feature for capturing any fluid which has sprayed out of the cyst lumen.

The transport passage for the bag can be formed in the surgical instrument, e.g., inside the shaft. If the surgical instrument is inserted into a cannula, alternatively there is the possibility that the transport passage lies in the intermediate space beside the surgical instrument (e.g., the shaft) and the internal wall of the cannula.

The bag preferably has a loop (e.g. made of wire) with two free end sections by which loop the bag edge is guided. The free end sections of the loop can be set up to push the bag forward and pull it back in the transport passage. Advantageous is an auxiliary thread which grips the bag in the region of the bag edge and with the help of which the bag edge can be pulled over the suction head. This auxiliary thread can be guided in the transport passage as well .

In a preferred version of the invention, the surgical instrument is set up for use in the removal of cysts of the ovaries (e.g., adapted in terms of size and shape and/or provided with corresponding information and instruction leaflets) . The suction head is laparoscopically guided to a cyst, the cyst is secured and fixed by suction with the suction head, a hollow needle is ad- vanced towards the cyst in the operating channel which is present in this case, the wall of the cyst is penetrated by the tip of the hollow needle, the content of the cyst is sucked up via the hollow needle, and preferably the remains of the cyst are sucked up via the suction head.

The invention is explained in the following, using embodiments. The drawings show in

Figure 1 a schematic overall view of a version of the surgical instrument according to the invention,

Figure 2 an enlarged view of the suction head and of the distal region of the shaft of the surgical instrument from Figure 1,

Figure 3 a schematic longitudinal section through a particularly preferred version of the surgical instrument according to the invention,

Figure 4 an enlarged view of the suction head and of the distal region of the shaft of the surgical instrument from

Figure 3 ,

Figure 5 a representation as in Figure 3 , wherein a hollow needle is inserted into the surgical instrument,

Figure 6 in parts (a) to (c) schematic views of the use of a version of the surgical instrument according to the invention which has a bag as an additional component and Figure 7 in parts (a) to (i) schematic views of consecutive operation stages in the removal of a cyst by means of a version of the surgical instrument according to the invention which has an operating channel for pushing in a hollow needle. In Figure 1 a version of the surgical instrument 1 is shown in schematic view. The surgical instrument 1 has a handle 2 from which a shaft 4 extends . Located at the distal end of the shaft 4 is a suction head 6 which widens in distal direction. An ope- rating element 8 is arranged in the region of the handle 2. Coupled to the end of the handle 2, via a quick-release coupling not shown in Figure 1, is a hose 9 which leads to an external negative-pressure source (e.g. a negative-pressure blower or a vacuum- or negative-pressure pump) .

The operating element 8 is shown in Figure 1 in a neutral middle position. It can be moved in distal direction, i.e. towards the suction head 6, and in proximal direction, i.e. in the opposite direction. In the case of movement in proximal direction, a valve which is not illustrated in the Figures opens so that the suction opening (s) in the suction head 6 are connected to the negative-pressure source via (at least) one negative-pressure duct running in the shaft 4 and the external hose 9. If on the other hand the operating element 8 is moved in distal direction, a ventilation valve opens so that the negative pressure in the negative-pressure duct and at the suction opening or the suction openings is reduced. In the middle position both valves are closed. How such a valve control can be structured is explained further above and is familiar to a person skilled in the art. Other types of control device and other modes of operation for controlling the negative pressure■ in the negative-pressure duct are also conceivable.

In the embodiment, the shaft 4 has a length of 200 mm and the suction head 6 has a maximum external diameter of 30 mm. The shaft diameter 4 is approx. 10 mm, so that the shaft 4 can be guided through a standard cannula with a 12-mm external diameter when the suction head 6 is pressed together (see below) . In another version the shaft 4 has a greater diameter so that it still passes through a trocar with an 18-mm external diameter. Figure 2 shows the distal region of the shaft 4 with the suction head 6 of the surgical instrument 1 from Figure 1 in an enlarged view. The suction head 6 extends from the distal end 10 of the shaft 4 and widens frustum-like towards its distal end 12. In the embodiment a total of eight suction openings 14 are provided which surround a central opening 16. The opening 16 forms the end of an operating channel which runs in the internal space of the shaft 4 and into which a surgical tool can be inserted into the surgical instrument 1 from a further opening located at the opposite end of the operating channel in the proximity of the handle 2. The eight suction openings 14 form the distal end of a negative-pressure duct which runs in the internal space of the shaft 4 separated from the operating channel and which can be connected to the hose 9 via the valve control activated via the operating element 8.

The operating channel has, e.g., an internal diameter of 3 mm which is sufficient for the use of a thin surgical tool such as e.g. a hollow needle, or of 10 mm, if thicker surgical tools are to be used. The respective surgical tool can be moved in longitudinal direction inside the operating channel. Preferably, the opening of the operating channel in the region of the handle 2 has a ring-shaped seal which fits to the surgical tool, in order that any excess pressure in the inside of the patient' s body, as is customary in the case of endoscopic operation techniques, cannot escape .

In the embodiment, the suction head 6 is made from an elastic silicone material. It can therefore be pressed together in a compressed state in which its maximum diameter is not greater than the shaft diameter 4. Therefore the surgical instrument 1 can be inserted through a cannula; the suction head 6 returns to its original shape (operating state) as soon as it emerges from the cannula in the inside of the patient. In Figure 3 a particularly preferred version of the surgical instrument is shown, here numbered 20, in a schematic longitudinal section.

Extending from a handle 22 is a shaft 24 at the distal end of which sits a suction head 26 which widens conically in distal direction. In the embodiment, the suction head 26 consists of an elastic silicone material and can be pressed together into a compressed state, as in the previously described version.

The surgical instrument 20 can be connected to a negative-pressure source via a hose connection 28. The hose connection 28 leads to a channel 30 in the handle 22. Located at the end of the channel 30 is an operating button 32 which is pre-tensioned by means of a coil spring 34 into the position shown in Figure 3. The end of the channel 30 is thereby closed. If the operating button 32 is pressed to the left against the. action of the coil spring 34, a ring-shaped recess 36 ensures a connection between the channel 30 and a channel section 38 which opens into the internal space 40 of the shaft 24. The entire internal space 40 of the shaft 24, which is not subdivided further in the embodiment, thereby acts as a negative-pressure duct. There can be located next to the operating button 32 a further operating button (not illustrated in Figure 3) , the internal space 40 of the shaft 24 being ventilated (preferably via a filter) when the further operating button is activated.

At the distal end 42 of the suction head 26 a single opening 44 is provided which simultaneously serves as suction opening and as distal opening of an operating channel, see also Figure 4. At the opposite end of the shaft 26 this operating channel has an inlet 46 which is formed in an elastic seal 48. The seal 48 is constructed so that in the position shown in Figure 3 the inlet 46 is closed. Located in the internal space 40 of the shaft 24 is a guide device 50 by means of which the operating channel is defined. The guide device 50 serves as a directing device so that a long surgical tool, which is inserted into the inlet 46, runs essen- tially along the longitudinal axis of the shaft 24 and can emerge from the central region of the opening 4 . In the embodiment the guide device 50 consists of four projections arranged in the manner of a funnel, of which two can be seen in the plane of Figure 3 ; the other two are arranged perpendicular thereto . Between these projections are large recesses so that the free cross-section of the internal space 40 is not significantly reduced and also larger tissue parts such as, e.g., remains of cysts can be sucked into the surgical instrument 20 via the opening 44. In principle the guide device 50 is dispensable, e.g. if more precise positioning of the surgical tool is not required; in this case the entire internal space 40 of the shaft 24 defines the operating channel.

Figure 5 shows how a hollow needle 52 serving as a surgical tool is inserted into the operating channel. Its bevelled tip 54 protrudes from the opening 44. In the internal space 40 of the shaft 24 the guide device 50 defines the position of the hollow needle 52. At the inlet 46 the seal 48 fits tightly to the hollow needle 52. The hollow needle 52 can be connected to a sepa- rate negative-pressure source via its proximal end 56.

Represented in Figure 6 is the distal region of a surgical instrument 20' which is inserted into a cannula 60. The surgical instrument 20' is constructed like the surgical instrument 20 described with reference to Figures 3 and 4 (which is why otherwise the same reference numbers are used as in Figures 3 and 4) , but has a bag 62 as an additional component.

Figure 6 shows in part (a) how the bag 62 in a folded state can be advanced through a transport passage alongside the shaft 24 in the internal space of the cannula 60 (arrow A) . The bag edge 63 is guided and held by a loop 64, see Figure 6 part (b) . In the embodiment, the loop 64 is made from a thin elastic wire. The loop 64 has two free end sections 66 and 67 which run essentially in a straight line and allow the bag 62 to be pushed forward and pulled back via the cannula 60. In the embodiment the two end sections 66 and 67 each carry a piece of hose. The distal ends of these two pieces of hose are located on the bag edge 63 (positions F) , while the proximal ends are accessible to the operator. When the bag 62 has been advanced far enough in distal direction, the elastic action of the loop 64 ensures that the bag unfolds and opens so that the state shown in Figure 6 part (b) is achieved. If the bag edge 63 is now held at the positions F by means of the two pieces of hose, while the two end sections 66 and 67 of the loop 64 (i.e. the wires guided inside the pieces of hose) are pulled in the direction of the arrows B and C, the bag 62 closes. An auxiliary thread 68, which is illustrated in Figure 6 part (b) , can be used to guide the bag edge 63. To this end, the auxiliary thread 68 is pulled in the direction of arrow D, also in proximal direction, as a re- suit of which the bag edge 63 swivels in the direction of the arrow E until the suction head 26 is received by the bag 62. Figure 6 part (c) shows this state.

The bag 62 ensures an additional fixing, e.g. of a cyst, at the suction head 26 and furthermore protects the patient from contaminations through content sprayed out of the cyst. In the state according to Figure 6 part (c) , the surgical instrument 20' including the bag 62 can be pulled in proximal direction through the cannula 60 and thus be removed from the inside of the pa- tient.

Figure 7 schematically illustrates in parts (a) to (i) consecutive operation stages in the removal of a cyst, e.g. a cyst of the ovaries. A surgical instrument of the type described using Figures 3 to 5 is used. The cyst is numbered 70. A cannula 74 is inserted into the body wall 72. Part (a) shows how the shaft of the surgical instrument, here numbered 80, is advanced in the cannula 74 in distal direction (i.e. in the direction of the arrow shown). The suction head 82 of the surgical instrument is still in the compressed state in part (a) .

The suction head 82 moves into its operating state when it has completely emerged from the cannula 74, part (b) .

The shaft 80 is advanced until the suction head 82 fits to the cyst 70, part (c) . Now the suction opening in the suction head 82 is connected to the negative-pressure source via the negative-pressure duct. The cyst 70 is thereby secured by suction and held firmly. The cyst 70 is sucked somewhat into the suction head 82 where the suction head 82 engages the cyst, part (d) .

In the next step, which is represented in part (e) , the operator advances a hollow needle 84 through the operating channel of the shaft 80 in distal direction until the tip 86 of the hollow needle 84 has penetrated the wall of the cyst 70 and projects into the internal space of the cyst 70, part (f) .

The content of the cyst 70 is now sucked up via the hollow need- le 84, for which purpose the proximal end of the hollow needle 84 is preferably connected to a separate negative-pressure source. The cyst 70 becomes smaller and smaller, parts (f) and (g) .

Finally, the remains of the cyst 70 are so small that they can be completely sucked up by the suction head 82 or at least pass through the cannula 74. The shaft 80 can therefore be drawn back in proximal direction, wherein the suction head 82 is folded in its compressed state, parts (h) and (i) .

Claims

1. Surgical instrument, in particular for the treatment of cysts, with a suction head (6; 26) which has at least one suction opening (14; 44) and is set up to fit tightly to bodily tissue, wherein the suction opening (14; 44) is connectable to a negative-pressure source via a negative- pressure duct (40) .

2. Surgical instrument according to claim 1, characterized in that the suction head (6; 26) is arranged at the distal end (10) of a shaft (4; 24) .

3. Surgical instrument according to claim 2, characterized in that the suction head (6; 26) widens in distal direction.

4. Surgical instrument according to claim 3, characterized in that the suction head (6; 26) is flexible and/or foldable and, in a compressed state, has a maximum diameter which at most is as great as the diameter in the distal end region of the shaft (4; 24) .

5. Surgical instrument according to claim 4, characterized in that the suction head (6; 26) is self-expandable from the compressed state into its operation state.

6. Surgical instrument according to one of claims 2 to 5, characterized in that the shaft (4; 24) has at least one operating channel (40, 50) which has an opening (16; 44) at the suction head (6; 26) , the operating channel (40, 50) being set up to receive a surgical tool, preferably a hol- low needle (52) or a morcellator.

7. Surgical instrument according to claim 6, characterized in that the surgical tool (52) received by the operating chan- nel (40, 50) can be moved in the longitudinal direction of the operating channel (40, 50) .

Surgical instrument according to claim 7, characterized in that the operating channel (40, 50) has, in the region of the surgical instrument (20) opposite the opening (44) relative to the longitudinal direction of the shaft (24) , an inlet (46) which is preferably provided with a seal (48).

9. Surgical instrument according to one of claims 6 to 8, characterized in that there is provided at the suction head (26) just one suction opening (44) which is identical to the opening (44) of the operating channel (40, 50) and preferably extends over at least 50% of the cross-section area, measured at the distal end (42) of the suction head (26) , of the suction head (26) .

10. Surgical instrument according to claim 9, characterized in that the operating channel (40, 50) and the negative-pressure duct (40) are connected to each other with regard to pressure equalization, wherein, preferably, the negative- pressure duct is formed by the internal space (40) of the shaft (24) and the operating channel therein is defined by a guide device (50) .

11. Surgical instrument according to one of claims 1 to 10, characterized by a control device (8; 32, 36) which is set up to control the negative pressure in the negative-pressu- re duct (40) .

12. Surgical instrument according to claim 11, characterized in that the control device (8) is set up alternatively to connect the negative-pressure duct to the negative-pressure source or to ventilate it.

13. Surgical instrument according to claim 11 or 12, characterized in that the control device (8; 32, 36) has a valve control which preferably can be operated from a handle (2; 22) .

1 . Surgical instrument according to one of claims 1 to 13 , characterized by a bag (62) which has a folded state and an unfolded state, the bag (62) when in the folded state being transportable to the suction head (26) via a transport passage, and the suction head (26) being receivable by the bag (62) via the opening at the bag edge (63) when the bag (62) is unfolded.

15. Surgical instrument according to claim 14, characterized in that the bag (62) has a loop (64) , preferably made of wire, with two free end sections (66, 67) by which loop the bag edge (63) is guided.

16. Surgical instrument according to claim 15, characterized in that the free end sections (66, 67) of the loop (64) are set up to push the bag (62) forward and pull it back in the transport passage.

17. Surgical instrument according to one of claims 14 to 16, characterized in that the transport passage is provided in the surgical instrument.

18. Surgical instrument according to one of claims 14 to 16, characterized in that the transport passage is provided alongside the surgical instrument (20' ) when the surgical instrument (20' ) is inserted into a cannula (60) .

19. Surgical instrument according to one of claims 14 to 18, characterized by an auxiliary thread (68) which grasps the bag (62) in the region of the bag edge (63) and with the help of which the bag edge (63) can be pulled over the suction head (26) .

20. Surgical instrument according to one of claims 1 to 19, characterized in that the surgical instrument (1; 20; 20' ) is designed as an endoscopic or a laparoscopic instrument.

21. Surgical instrument according to claim 7, characterized in that the surgical instrument is set up for use in the remo- val of cysts (70) of the ovaries, wherein the suction head

(82) is laparoscopically guided to a cyst (70) , the cyst

(70) is secured and fixed by suction with the suction head

(82) , a hollow needle (84) in the operating channel is pushed towards the cyst (70) , the wall of the cyst (70) is penetrated by the tip (86) of the hollow needle (84) , the content of the cyst (70) is sucked up via the hollow needle (84) and the remains of the cyst (70) are preferably sucked up via the suction head (82) .