WO2015000561A1 - Device for the endoscopic application of self-closing medical clips - Google Patents

Abstract

The invention relates to a device for the endoscopic application of self-closing medical clips (3) in the body of a living being, in particular for stopping internal bleeding, comprising a catheter tube (1) having a distal end to be placed in the body and a proximal end associated with an operating apparatus and comprising an actuating apparatus (7, 9), which extends in the catheter tube (1) from the operating apparatus to the region of the distal end and by means of which a clip (3) to be applied can be moved out of the distal end and can be moved axially in the direction of the proximal end within an actuating sleeve (5) associated with the clip for the opening and closing of the legs (11) of the clip. If there are a plurality of clips (3) in the catheter tube (1), the clip to be applied can be pushed out of the catheter tube (1) by the clip (3) that follows the clip to be applied. The device is characterized in that a barrier apparatus (43, 47) is provided, which prevents clips (3) that follow one another in the catheter tube (1) from getting caught on each other.

Description

 Device for endoscopic application of closing medical clips.

The invention relates to a device for endoscopic application of closing medical clips in the body of a living being, in particular for the stabilization of internal bleeding, with a catheter tube having a distal end to be placed in the body and a proximal end assigned to an operator device and having a catheter tube of the operator device extending to the region of the distal end actuating means by means of which a clip to be applied from the distal end movable and for opening and closing its legs within an associated actuation sleeve axially in the direction of the proximal end is movable, wherein at a plurality of clips located in the catheter tube which can be pushed out of the catheter tube by the clip following it. Such a catheter tube is regularly part of an endoscope in practical use.

For the treatment of internal bleeding, for example in the upper or lower gastrointestinal tract, such as variceal bleeding, bleeding after polypectomy or ulcer bleeding, with the aid of flexible endoscopes, various methods are known. Examples include coagulation, sclerosis tion, ligature or the application of self-closing clips called. All of the known methods are disadvantageous in various respects, be it that the therapeutic success is not satisfactory or the application is complicated or very expensive. As relatively low-priced, ie with fewer disadvantages, the clip method has recently become established as a preferred method, partly because, as further applications of clips, it is also possible to apply markings for identifying diagnostic and X-ray areas as well as surgical treatments, for example the removal of polyps in the gastrointestinal tract.

In this related art, WO 2005/009254 AI a device of the type mentioned is disclosed. This known device provides for self-closing clips in each case an actuating sleeve belonging to the clip in which the clip can be moved axially, for example by means of a pull rope forming part of the actuating device, the legs of the clip being spread during a first section of the actuating travel and subsequently Closed course of the movement to perform by the clamping ends of the legs of the staple process. The known device also allows the setting of several clips, without removing the catheter tube from the body, whereby a shortened Behandlungsabiauf is achievable, which reduces the risk of the patient to be treated and the risk of incorrect placement in heavy bleeding.

Based on this prior art, the invention has the object to provide a device of the type considered available, which is characterized while maintaining the advantages of the mentioned known solution by improved application security. According to the invention this object is achieved by a device having the features of claim 1 in its entirety.

According to the characterizing part of claim 1, an essential feature of the invention is that a barrier device preventing mutual interlocking of clips following one another in the catheter tube is provided. As a result, the advantage of being able to set more than one clip without having to take the catheter tube out of the body and reinsert it without exploiting the risk of a malfunction when successive clips abut one another under the displacement force generated by the actuating device.

Advantageously, the barrier device can be effective between the actuation sleeve of respective clips and the legs of respectively subsequent clips.

With particular advantage, the actuating sleeve to form the barrier device on its side facing the subsequent clip end face have an opening whose free diameter is smaller than the transverse to the longitudinal axis of the catheter tube measured distance of the outer sides of the legs of the closed clip. The so small dimensioned diameter of the opening of the actuating sleeve forms an effective safeguard against engagement of the leg ends in the opening. In particular, an intervention could therefore lead to an entanglement, because the clips in question at their leg ends have hook-like, bent clip parts for the detection of body tissue. The opening size on the actuating sleeve may be reduced to a diameter which is sufficient for performing a Zugseilanordnung the actuator, but is less than the inner diameter of the actuating sleeve in other sections. With particular advantage, the arrangement may be such that the formation of the barrier means the respective leg of a clip at its free end a clamp member with at least two engagement claws has with corresponding trained engagement claws of the clamp member of the other leg of this clip at its closed State under investment of the adjacent engagement claws limit a circumferential space whose free cross-section at each point is smaller than the free diameter of the opening of the actuating sleeve of the preceding clip. The so small dimensioned space between the closed leg ends prevents snagging by overlapping an opening edge of the actuating sleeve.

With particular advantage, it can be provided that, with the formation of the barrier device, the respective clamp part is bent with respect to the longitudinal extent of the leg in the direction of the clamp part of the other leg at an angle which is more than 90 °. Due to the fact that the staple parts are inclined backwards at an angle away from the preceding actuating sleeve, not only does the holding effect for gripped body tissue improve, but the recessed course of the staple parts also increases the security against snagging.

With particular advantage, the arrangement can be made such that, forming the barrier device, the inner passage of the actuating sleeve, starting from the opening on the front side facing the subsequent clip, widens in the direction of the other end face inner diameter, preferably in the form of a has at the opening adjoining cone. Regardless of the size of the frontal opening, therefore, the interior of the actuating sleeve may have an optimum for the operation of the respective clip diameter profile. With particular advantage, the actuating sleeve to form the barrier device on the subsequent clip facing end face have an outer diameter which is greater than the transverse to the longitudinal axis of the catheter tube measured distance of the outer sides of the legs of the closed clip, with particular advantage of the outer diameter in the region Opening can be approximated to the inner diameter of the catheter tube. A particularly secure protection against entanglement can be achieved in embodiments in which, forming the barrier device, each leg has at least in a central longitudinal section such a curved profile shape that a channel-like cavity is formed when the clip is closed between adjacent legs. Such a profile shape leads to a stiffening, which, even with slender legs, counteracts a bending out of the clamp members under load. In addition to the thus achieved increased security against snagging with a preceding actuating sleeve results in increased security of the clamping effect on the body tissue.

The invention with reference to an embodiment shown in the drawing is explained in detail. Show it:

Fig. 1 shows a relation to the natural size in an enlarged scale drawn longitudinal section only the distal end portion of a catheter tube as part of an embodiment of the device according to the invention; Fig. 1 a a greatly enlarged drawn partial longitudinal section of the designated in Fig. 1 with I area, wherein the Zugseilanordnung the actuator Wegge is; a perspective and in an even larger scale drawn oblique view of a closing medical clip for use in the device according to the invention;

3a and 3b are sectional views of a single clip with associated Betätigungs¬ sleeve, wherein a first operating state at the end of the opening and Schließzyklusseses of the clip is shown and in Fig. 3b, the sectional plane with respect to FIG. 3a rotated by 90 °, and Fig. 4a and 4b to

 FIGS. 8a and 8b are sectional views corresponding to FIGS. 3a and 3b, wherein successive operating states are shown at the end of the opening and closing cycle of the clip.

FIG. 1 shows the distal end section of a catheter tube 1 as part of the exemplary embodiment of the device according to the invention to be described. The catheter tube 1 is part of a flexible instrument, which may be of conventional type in medical technology and in an inner working space of an endoscope device including lighting and / or other purposes (for example, suction) can be inserted. The proximal end of the catheter tube 1 (not shown) is operatively connected to a handling and operating device located at the respective end. According to the light Width of the work spaces in flexible endoscopes, the outer diameter of the catheter tube 1 is 2.7 mm.

The device according to the invention is suitable for the application of closing medical clips 3 of a design, as can be seen most clearly from FIG. 2. Medical clips of this construction, which are formed from a material customary for medical purposes, such as stainless steel, are known from the already mentioned above document WO 2005/009254 A1. As explained in this document, can be actuated in the course of an opening and closing cycle pushed out of the front end of the catheter tube 1 Clip3 by axial displacement in its actuating sleeve 5. In the example shown here, a pull cable loop 7 is provided as part of the associated actuator for this axial movement. As a further component of the actuating device, a sliding tube 9, which is shown only in FIG. 1, is provided, by means of which the clip 3 to be applied can be pushed out of the catheter tube 1. As shown in FIG. 1, a plurality of clips 3 with associated actuating sleeve 5 are arranged one behind the other in the catheter tube 1 and pushed out successively for application. In Fig. 1, for example, two clips 3 are arranged with actuating sleeve 5 in the catheter tube 1. It is understood that more or less clips could be arranged for sequential application in the catheter tube 1.

As shown in FIG. 2, the known from the above-mentioned document clip 3 has two legs 1 1, which, without crossing over, are adjacent to each other and are bent towards each other at the free leg end 14. At the end opposite the leg end 14, the legs 1 1 are connected by an end web 19 with each other, which is traversed by two adjacent cable openings 1 5, through which one strand of the cable loop 7 is guided. Between the rope openings 1 5 is a bridge 1 7 greatly reduced material thickness, so that the Bridge 1 7 forms a predetermined breaking point, which allows the detachment of the pull cable loop 7 to release the clip 3 after the application. Outwardly, the cable openings 1 5 are covered by a terminal edge 31. Offset from the end bar 1 3 against the free leg end 14, each leg 1 1 has a first crease 19 bulged outward and, offset further against the leg end 14, a second crease 21, which together form a supporting point for the mutual abutment of the legs 1 1 form. Of the self-closing clip 3 with normally resilient legs 1 1, Fig. 2 shows a partially spread state of the legs 1 1, as it is caused by the action of the forces indicated in Fig. 2 with F, which are effective when the clip 3 is retracted into the associated actuating sleeve 5. From the respective second kink 21 of the legs 1 1 offset forward is a third bend 22 formed in the form of a further bulge to the outside. In the meantime, each leg 1 1 extends from the second kink 21 to the free end 14 of the respective leg 7, in particular in the region of the first fifth of the respective leg 1 1, calculated from the second kink point

21 on and in the direction of this second kink 21 to, the third kink

22, which, like the first kink 19, projects outward. While the first bend 19 is formed by tapering adjacent leg webs, the adjacent leg pieces for the third bend 22 have a flat slope course. As a result of the tarnishing of the limbs 11 to a region located between the second kink 21 and a slightly outwardly arched third kink 22 on a control surface formed by an opening cone 25 (FIGS. 3 to 8) of the receiving sleeve 5, the legs 1 begin 1 approach each other to reduce the closing angle.

As the enlarged view of Fig. 2 can be removed, each leg 1 1 at the leg end 14 a against the respective opposite leg 1 1 bent clamp member 44, at its free end Engagement claws 46 protrude for engagement in the body tissue to be clamped. The engagement claws 46 are formed by the tip ends of a V-shaped depression located in the clamping region 44. In abutting legs 1 1 is thus, as can be seen from Fig. 1 a, a free receiving space 48 formed between the clamp members 44.

Through this receiving space 48 extends (not shown in Fig. 1 a) Zugseilanordnung. 7

3a, 3b to 8a, 8b illustrate the sequence of the opening and closing cycle of the applied to be pushed out of the catheter tube 1 clip 3 with associated actuating sleeve 5. Fig. 3a, 3b show the state in which the clip 3 with his Knick 19 is already retracted after entering an opening cone 25 in the narrower cylinder part 23 of the actuating sleeve 5, so that the state of the complete opening of the legs 1 1 is reached. Fig. 4a, 4b show the state in which start by further retraction, the legs 1 1 at the opening cone 25, whereby the legs 1 1 are moved against each other, so that the closing operation begins. Fig. 5a, 5b show the progress of the closing movement of the legs 1 1 when pulled into the opening cone 25. Fig. 6a, 6b to 8a, 8b show the further course of the closing movement, wherein, as most clearly illustrates the Fig. 8b, the opening cone 25 as the control surface of the oncoming leg 1 1 causes the complete closing of the clip 3, wherein Fig. 8b shows the state shortly before the final closing of the legs 1 1. Upon further retraction and thereby caused closing movement by tarnishing the legs 1 1 on the control surface of the opening cone 25, the engagement of the leg ends 14 takes place at the treatment site and thereby the setting of the clip 3. To completely release the thus applied clip 3 and 3 at the application site leave, can now be removed from the end bar 1 3 of the clip 3 by increasing the tensile force on the cable loop 7, by breaking the predetermined breaking point formed by the bridge 1 7 (Fig. 2). Against this tensile force is the appli- clipped clip 3 by conditioning its actuating sleeve 5 on the sliding tube 9 (Fig. 1) supported.

The details of the barrier device, which prevents mutual hooking of successive clips 3 in the movement effected by the actuating device by means of the sliding tube 9, are more clearly shown in the enlarged view of FIG. 1a. As shown, the outer diameter of the actuating sleeve 5 is greater in the region 42 adjacent to the proximal end 49 than in the adjoining distal end region 54. In addition, the opening 43 at the proximal end 49 of the inner passage 41 of the actuating sleeve 5 has a Diameter d, which is smaller than the measured transverse to the longitudinal axis 46 distance A between the closed legs 1 first Thus, between the outer diameter of the actuating sleeve 5 at the proximal end 49 a large, to the vicinity of the inner wall of the catheter tube 1 reaching contact surface 47 is available, so that overreaching of the end 49 of the actuating sleeve 5 is avoided by the clamp members 44 at the leg ends 14 , By compared to the distance A of the legs 1 1 reduced diameter d of the opening 43 and a hooking by engagement of the clamp members 14 in the inner passage 41 of the actuating sleeve 5 is prevented. As shown in Fig. 1 a also shows, the formed with closed legs 1 1 between the engagement claws 46 of the clamp members 44 receiving space 48 is smaller than the free diameter of the opening 43. Notwithstanding the illustration of Fig. 1 a, the opening 43 in diameter still be further reduced to a size sufficient for the passage of the cable loop 7 of the actuator. For example, the diameter may be selected to correspond to the width of the receiving space 48 formed between the staple portions 44 of the leg ends 14. As FIG. 1a further shows, the clip parts 44 are bent in such a way that they form an angle α with the adjoining leg webs which is smaller than 90 °. As a result, the parenthesis parts 44 one of the contact surface 47 of the preceding actuating sleeve 5 receding course.

Claims

Patent claim Device for the endoscopic application of closing medical clips (3) in the body of a living being, in particular for the stabilization of internal bleeding, with a catheter tube (1) having a distal end to be placed in the body and a proximal end associated with an operator device and having a Catheter tube (1) of the operator device to the region of the distal end extending actuator (7, 9), by means of which a clip to be applied (3) from the distal end movable and for opening and closing its legs (11) within him associated actuating sleeve (5) is axially movable in the direction of the proximal end, wherein at several in the catheter tube (1) located clips (3) of the catheter to be applied by the next clip (3) from the catheter tube (1) can be pushed, characterized in that a mutual entanglement of in the catheter tube (1) successive n Clips (3) preventing barrier means (43, 47) is provided. Apparatus according to claim 1, characterized in that the barrier means (43, 47) between the actuating sleeve (5) of respective clips (3) and the legs (11) of each subsequent clips (3) is effective. Apparatus according to claim 1 or 2, characterized in that the formation of the barrier means (43, 47), the actuating sleeve (5) on its the subsequent clip (3) facing end face an opening (43) whose free diameter (d) is smaller as the distance (A) measured transversely to the longitudinal axis (46) of the catheter tube (1) of the outer sides of the legs (11) of the closed clip (3). Device according to one of the preceding claims, characterized in that under Bi tion of the barrier device (43, 47) of jewei age leg (1 1) of a Cl ip (3) at its free end (14) a Klammertei l (44) Has at least two engagement claws (46), which with corresponding ausgebi ldeten engagement claws (46) of Klammertei ls (44) of the other leg (1 1) of this Cl ip (3) in the closed state under the adjacent engagement claws (46) a Limiting receiving space (48) for grasped tissue whose free cross-section at each Stel le is smaller than the free diameter of the opening (43) of the actuating sleeve (5) of the preceding clip (3), as long as the clip (3) as a whole in the catheter tube ( 1) is included. Device according to one of the preceding claims, characterized in that to form the barrier means (43, 47) the jewei time Klammertei l (44) relative to the longitudinal extension of the leg (1 1) in the direction of the clamp member (44) of the other leg (1 1) is bent at an angle (a) which is less than 90 °. Device according to one of the preceding claims, characterized in that under Bi tion of the barrier device (43, 47) of the inner passage (41) of the actuating sleeve (5), starting from the opening (43) facing the subsequent Cl ip (3) End face, extending in the direction of the other end face inner diameter, preferably in the form of a to the opening (43) adjoining cone (55). Device according to one of the preceding claims, characterized in that under Bi tion of the barrier device (43, 47), the actuating sleeve (5) on the the subsequent Cl ip (3) facing Sti rnseite has an outer diameter which is larger as the transversely to the longitudinal axis (46) of the catheter tube (1) measured distance (A) of the outer sides of the legs (1 1) of the closed Cl ip (3). Device according to one of the preceding claims, characterized in that forming the barrier means (43, 47) the outer diameter of the actuating sleeve (5) in the region (42) of the opening (43) on the cl ip the next cl (3) facing Sti rnseite the inner diameter of the catheter tube (1) is approximated. Device according to one of the preceding claims, characterized in that, forming the barrier device (43, 47), each limb (11) has such a convex profiled shape at least in a central longitudinal section that, when the Cl is closed, (3) between adjacent limbs ( 1 1) a channel-like cavity (57) is gebi LED.