WO2003041593A1

WO2003041593A1 - Blood flow stopping instrument for endoscopic surgery

Info

Publication number: WO2003041593A1
Application number: PCT/SE2002/002014
Authority: WO
Inventors: Staffan TERNSTRÖM
Original assignee: Stille Surgical AB
Current assignee: Stille Surgical AB
Priority date: 2001-11-14
Filing date: 2002-11-06
Publication date: 2003-05-22
Anticipated expiration: 2004-05-14
Also published as: SE520481C2; SE0103772L; SE0103772D0

Abstract

The present invention relates to a device for use in endoscopic operations, for example laparoscopic surgery, to stop or restrain internal bleedings. The device comprises a sleeve, whose distal end is adapted to be inserted through an opening in the patient's body, a blood flow stopping means comprising a structure surrounding a through-opening for mechanical compression of a blood vessel on each side of any injury to the vessel, and at least one actuator which extends through the sleeve and which at its distal end is connected to the blood flow stopping means, the actuator being movable relative to the sleeve for actuating the blood flow stopping means.

Description

BLOOD FLOW STOPPING INSTRUMENT FOR ENDOSCOPIC SURGERY

Field of the Invention

The present invention relates to a device for use in endoscopic operations, for example laparoscopic surgery, to stop or restrain internal bleedings . Background

Laparoscopic surgery, or so-called keyhole surgery, is becoming increasingly important in general surgery and gynaecological surgery. It presents many advantages compared to conventional surgery both to the patient and society. In laparascopic operations, small holes are made in the abdominal wall through which trocars (tubular sleeves) are introduced, and through these trocars the laparoscope and one or more working instruments are inserted. The abdomen is also filled with gas to create a larger space which allows for easier viewing and accessibility. The image of the operation site is transmitted to a monitor and the intervention can be performed by means of suitable working instruments which are inserted into the abdominal cavity via trocars. However, in endoscopic surgery bleedings sometimes occur that are hard to stop, for example, because they are difficult of access. Owing to this, open surgery may be necessary to stop the bleeding. Sometimes such bleedings must be stopped very quickly if the bleeding is massive and endangers the patient's safety. In case of a bleeding which is massive or difficult of access, the first step is to stop the flow of blood in the bleeding site, the second step is to identify the damaged vessels and make them accessible, and the third step is to repair the damage. In order to repair the vascular injury, the bleeding must be stopped, which can be done by compressing the vessel on each side of the injury. Therefore there is a need for a device which can be used in endoscopic surgery to stop or restrain bleedings.

Summary of the Invention The object of the present invention is to provide means for use in endoscopic operations to stop bleedings.

This object is achieved by means of a device according to the appended claims .

The invention relates to a device for stopping bleedings occurring in endoscopic surgery, comprising a sleeve, whose distal end is adapted to be inserted through an opening in the patient's body; a blood flow stopping means comprising a structure surrounding a through-opening for mechanical compression of a blood vessel on each side of an injury to the vessel; and at least one actuator which extends through the sleeve and which at its distal end is connected to the blood flow stopping means, the actuator being movable relative to the sleeve for actuating the blood flow stopping means. With the aid of the device according to the invention, the bleeding can be stopped via a small opening in the patient's body of the kind normally used in endoscopic interventions. The blood flow stopping means can be actuated from the distal end of the sleeve so as to be arranged over a bleeding site, thus stopping or restraining the blood flow. Owing to the through-opening of the blood flow stopping means, the treatment site is much easier to reach with other instruments, and diathermy equipment can, for example, be inserted into and ex- tracted from the treatment site, at the same time as the blood flow stopping means can be continuously kept in place and exert a blood flow stopping effect .

The device preferably comprises two actuators which extend through the sleeve and which at their distal ends are connected to the blood flow stopping means, at least one and preferably both actuators being movable relative to the sleeve. This further improves the capability of actuating the blood flow stopping means, and the device is much easier to use.

Furthermore, the blood flow stopping means can preferably assume a compressed position allowing insertion of the blood flow stopping means into the sleeve and an expanded position to stop a bleeding. This results in a blood flow stopping means having a contracted dimension allowing insertion into the sleeve while also having an expanded dimension offering a relatively large working space.

The blood flow stopping means preferably also comprises an at least partially elastically resilient material adapted to substantially automatically move the blood flow stopping means to the expanded position when it is positioned outside the sleeve. Owing to this, the instrument is easier to handle, since the blood flow stopping means already assumes a suitable form when extracted from the sleeve, thus being ready for use immediately. Moreover, the actuator is preferably made of a flexible material so as to be at least somewhat flexible, or comprises at least one joint. This increases the possibility of actuating the actuator and its accessibility. Preferably, the blood flow stopping means comprises a thin, circumferential structure, preferably a ring. In this connection, the expression ring not only refers to a circular shape, but also to other shapes offering an at least partially enclosed, open treatment site, such as an elliptic, rectangular or triangular shape. It is also preferable for the sleeve to comprise a through-opening for insertion of a surgical instrument, and at least one guiding means for guiding an actuator. Owing to this, the same sleeve and the same opening in the patient's body can be used for both the blood flow stopping instrument and other instruments for repairing the injury or the like. Brief Description of the Drawings

The invention will now be described in more detail by way of embodiments and with reference to the accompanying drawings, in which Fig. 1 is a perspective view of a device according to an embodiment of the invention, in which the device is in an active position;

Fig. 2 shows the device in Fig. 1 in a passive position for insertion, Fig. 2A being a perspective side view, Fig. 2B a cross-sectional view transversely to the axial direction and Fig. 2C a cross-sectional view along the axial direction;

Figs 3A and 3B show a first and a second embodiment, respectively, of a blood flow stopping means according to the invention;

Fig. 4 is a perspective view of a device according to an alternative embodiment of the invention; and

Fig. 5 shows an example of a working instrument which can be used together with the device according to the invention.

Description of Preferred Embodiments

The invention relates to a surgical instrument for stopping internal bleedings occurring in endoscopic sur- gery by temporary mechanical compression of a blood vessel on each side of an injury to the vessel, as shown in Fig. 1. The instrument comprises a sleeve 1, whose distal end 11 is adapted to be inserted through an opening in the patient's body, a blood flow stopping means 2 cora- prising a structure 21 surrounding a through-opening 22 for mechanical compression of a blood vessel on each side of an injury to the vessel and at least one actuator 3 which extends through the sleeve and which at its distal end 31 is connected to the blood flow stopping means 2. The actuator 3 is movable relative to the sleeve 1 for actuating the blood flow stopping means. Preferably, use is made of at least two actuators 3 , 3 ' , which consider- ably increases the distal control and the capability of actuating the blood flow stopping means.

The blood flow stopping means 2 comprises a surrounding structure 21, which at least partially surrounds a through-opening forming an open treatment site 22. The blood flow stopping means is preferably formed as an open ring, as shown in Fig. 3A. It will, however, be appreciated that many variants of rings are conceivable, such as circular, triangular, etc, as long as they clearly de- fine a partially surrounded, internal treatment site. The blood flow stopping means can be converted between a compressed and an expanded state. The compressed position allows the instrument to be inserted through an opening in the patient's body intended for this pur- pose, and in this state the blood flow stopping means can preferably be inserted into the sleeve. In the expanded position, the enclosed opening 22 is enlarged to facilitate application over a bleeding. In the compressed position, the blood flow stopping means can, for example, have an elongate, elliptic shape, whereas in the expanded position it assumes a more circular shape. In the expanded position, the blood flow stopping means can be passed down to a position over the bleeding site and pressed against the surrounding tissue, especially the bleeding vessel, so as to cause haemostasis.

The blood flow stopping means can be made of metal, plastic or other suitable materials. Preferably, the blood flow stopping means is made of an at least partially elastic material with at least some shape memory effect, resulting in the means automatically striving to assume a predetermined position. Most preferably, the blood flow stopping means strives towards the expanded position and assumes this position automatically when extracted from the sleeve. The blood flow stopping means, and in particular the enclosed opening, can be made in different sizes to fit various types of operations, different patients, different types of bleeding, etc.

It is also conceivable for the blood flow stopping means to be made of strips which are put together, and in that case a more rigid material can be used, such as metals with shape memory effect. This embodiment is shown in Fig. 3B. In this case, the connection to the actuators is advantageously located in the area where the strips are joined together. The device can comprise one, two or more actuators. Preferably, two actuators are used. The actuators 3, 3' are preferably designed in substantially the same way and arranged in the same way in the sleeve, although not necessarily. The actuators are axially movable relative to the sleeve and preferably also relative to each other. The actuators comprise a distal end 31, a proximal end 32 and a shank part 33, which interconnects the two ends. At the proximal end 32 of the actuators, a grip 34, handle or similar means is arranged to make the actuators com- fortable and easy to actuate. It would also be conceivable to arrange a common grip or handle to actuate several actuators .

The actuators are connected to the blood flow stopping means in the distal area. When several actuators are used, the distal ends are preferably connected to the blood flow stopping means at a certain distance from each other, preferably as far as possible from each other. In addition, the actuators are preferably movably connected to the blood flow stopping means, which allows a change of the angle between the blood flow stopping means and the actuators. Such a movable interconnection can consist of one or more joints, such as hinges or ball joints. It is also possible to interconnect the actuators by means of spacers made of a flexible material, such as threads or the like. When the actuators are movably connected to the blood flow stopping means, the latter can be applied against bleeding tissue within a large angular range. In principle, the blood flow stopping means can be arranged anywhere between a position substantially parallel to the axial direction of the sleeve and a position substantially perpendicular to said axial direction, and at all angles therebetween. However, if only one actuator is used, it is preferably fixedly connected to the blood flow stopping means.

In order to offer good actuating possibilities, it is also preferable for the actuators to be movable side- ways. This can be obtained by using elastic and flexible materials in the actuators, and/or by using one or more joints, such as hinges or ball joints, arranged somewhere along the actuators .

The actuators can, as mentioned above, be used to control the position of the blood flow stopping means, for example, to apply the same against a bleeding. But the actuators can also be used to re-shape the blood flow stopping means, for example, to make it more oval or round. Furthermore, one or more of the actuators can be lockable relative to each other or relative to the sleeve. For this purpose, locking means 35 can be provided, such as locking screws or other mechanical clamping means, hooks or the like. The locking means 35 can be arranged directly in the sleeve 1, as shown in the embodiment in

Fig. 1. Alternatively, they can be arranged in a separate part, such as a locking and actuating ring 36. This embodiment is shown in Fig. 4.

The sleeve 1 is preferably tubular and comprises at least one through-duct 13, a so-called lumen, which ends at a distal and a proximal end. The shape of the sleeve is preferably substantially round or elliptic in cross- section transversely to its axial direction. The distal end 11 is intended to be passed through an opening in the patient's body, while the proximal end 12 is intended to remain outside said opening in the body. The sleeve can also be designed to provide the opening in the body that is to be used, i.e. to make an incision through the wall surrounding the opening in the body, for example, the abdominal wall in laparascopic surgery, or thorax in thoracoscopic surgery. As an alternative, the sleeve can be inserted through another sleeve or trocar already inserted. The extension of the sleeve in its transverse direction is preferably much smaller than the extension of the blood flow stopping means in its expanded state. The sleeve preferably comprises a guiding means 14 for guiding the actuators 3. These guiding means can be cuts, grooves, slots or the like. Preferably, the guiding means comprise channels 14 arranged in the wall of the sleeve, as shown in Figs 2B and 2C. These channels can advantageously comprise slit openings or the like to permit insertion of the blood flow stopping means into the lumen of the sleeve. In this embodiment, the guiding means and the actuators will thus not interfere with the through-duct when the blood flow stopping means has been inserted. As a result, also other working instruments can be inserted through this duct, such as irrigator, aspirator, tongs, diathermy instruments and other conventional instruments for endoscopic surgery. Consequently, the working instruments can be inserted directly into the bleeding site. Fig. 5 shows an example of a working instrument 4 which can be used together with the device according to the invention. This working instrument is a diathermy instrument comprising a distal, active part 41, a proximal actuating part 42 and a shank part which is to be inserted into the sleeve 1. In Fig. 1, the same in- strument is shown in an active, inserted position.

The sleeve can also comprise a valve or the like, which prevents gas from leaking out of the opening in the patient's body if gas is used in the operation.

The insertion sleeve can be made of plastic and be disposable or intended for multiple use, but it is preferably made of a metal material, such as stainless steel. When inserting and extracting the sleeve, the blood flow stopping means can assume its compressed state and be at least partially inserted into the sleeve, as shown in Fig. 2A. When the actuators are pressed down, the blood flow stopping means is moved out of the distal opening of the sleeve and expands due to its tendency to assume an expanded form. Simultaneously, the actuators deviate from the axis of the sleeve. By moving the actuators relative to each other, the degree of opening and the inclination (relative to a plane through the distal aperture of the sleeve) of the blood flow stopping means can be adjusted. By inclining and rotating the sleeve, and by passing the actuators down more or less through the sleeve, the plane through the aperture/working open- ing of the blood flow stopping means can be adjusted so as to correspond to every topographic condition of the body cavity. The blood flow stopping means is then placed with its opening over the bleeding site and a suitable pressure is applied via the actuators to stop the bleed- ing.

Subsequently, when the bleeding has been stopped, the surgeon can relatively calmly irrigate/aspirate in the treatment site within the blood flow stopping means, and then repair the injury, for example, by diathermy (coagulate vessels and tissue) with the aid of other instruments .

The device according to the invention is suitable for laparoscopic surgery in the abdominal wall and abdominal cavity, but can also be used, in applicable parts, for the chest wall and chest cavity as well as for any body cavity which can undergo endoscopic surgery and which may involve similar problems when stopping bleedings .

The invention has now been described by way of em- bodiments. It will, however, be understood that many other variants are conceivable. The blood flow stopping means can, for example, be designed in a number of dif- ferent ways, the guidance of the actuators can be provided in different ways, etc. The device according to the invention can also be made of many different materials and in different sizes. Such variants and other obvious variants of the invention must be considered to fall within the scope of the invention as defined by the appended claims.

Claims

1. A device for stopping internal bleedings occur- ring in endoscopic surgery, comprising: a sleeve, whose distal end is adapted to be inserted through an opening in the patient's body; a blood flow stopping means comprising a structure surrounding a through-opening for mechanical compression of a blood vessel on each side of an injury to the vessel ; and at least one actuator which extends through the sleeve and which at its distal end is connected to the blood flow stopping means, the actuator being movable relative to the sleeve for actuating the blood flow stopping means .

2. A device as claimed in claim 1, comprising two actuators which extend through the sleeve and which at their distal ends are connected to the blood flow stop- ping means, at least one and preferably both actuators being movable relative to the sleeve.

3. A device as claimed in claim 2, wherein the actuators are movable relative to each other.

4. A device as claimed in any one of the preceding claims, wherein the blood flow stopping means can assume a compressed position allowing insertion of the blood flow stopping means into the sleeve and an expanded position to stop a bleeding.

5. A device as claimed in claim 4, wherein the blood flow stopping means comprises a structure surrounding the through-opening, which in the expanded position is substantially circular.

6. A device as claimed in claim 4, wherein the blood flow stopping means comprises a structure surrounding the through-opening and having two substantially symmetrically arcuate parts, which are interconnected at their ends .

7. A device as claimed in any one of claims 4-6, wherein the blood flow stopping means comprises an at least partially elastically resilient material adapted to substantially automatically move the blood flow stopping means to the expanded position when it is positioned outside the sleeve.

8. A device as claimed in any one of the preceding claims, wherein the actuator is made of a flexible material so as to be at least somewhat flexible .

9. A device as claimed in any one of the preceding claims, wherein the actuator comprises at least one joint .

10. A device as claimed in any one of the preceding claims, wherein the blood flow stopping means comprises a thin, circumferential structure, preferably a ring.

11. A device as claimed in any one of the preceding claims, wherein the blood flow stopping means comprises a threadlike or bandlike structure surrounding the through- opening.

12. A device as claimed in any one of the preceding claims, wherein the sleeve comprises a through-opening for insertion of a surgical instrument, and at least one guiding means for guiding an actuator.

13. A device as claimed in claim 11, wherein the guiding means comprises a channel for at least partially encasing the actuator.