Device for endoscopic removal of stones or calculi from the bile duct and pancreatic duct

Abstract

To provide a device for removing stones or calculi from a biliary tract and a pancreatic duct with an endoscope.SOLUTION: A device for endoscopically removing stones or calculi from a biliary tract and a pancreatic duct includes: a control wire being guided in a tube; a control element for axially moving the control wire in the tube, fixed to a proximal end of the control wire; and a catch basket composed of basket wires, fixed to a distal end of the control wire. The catch basket expands or contracts into a loop by axial movement of the control wire by the control element. The purpose thereof is to create advantageous possibilities for handling such a device, when lithotripsy is required. The control wire is separable from the control element and can be coupled to an actuating element for the lithotripsy of a stone contained by the catch basket, where the actuating element can be used to generate sufficient force on the catch basket.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] The present invention relates to a device for endoscopically removing stones or calculi from the biliary tract and pancreatic duct. The device has a control wire guided within a tube, a control element at its proximal end for axially moving the control wire within the tube, and a catch basket made of a basket wire fixed to its distal end. The catch basket is expanded or contracted into a loop shape by axially moving the control wire by the control element.

[0002] Furthermore, the present invention relates to a method for converting a device placed in the working channel of a medical endoscope, which can be performed after endoscopic retrograde cholangiopancreatography, for use in lithotripsy and removal of stones trapped by a catch basket, the device comprising a tube, a control wire guided within the tube, a catch basket distally connected to the control wire for accommodating the stone, and a control element engaging the tube and the control wire, the catch basket being expanded or contracted into a loop by axial movement of the control wire by the control element. [Background technology]

[0003] Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure used to visualize and examine a patient's bile and pancreatic ducts. A medical endoscope, equipped with a camera designed for side-viewing optics at its distal end, is inserted through the pharynx and into the patient's esophagus. The distal end of the endoscope passes through the stomach and into the duodenum. To further examine the patient's bile and pancreatic ducts and evaluate potential treatments, various endoscopic devices equipped with distal instruments are guided through the working channel of the medical endoscope into the area of ​​the bile and pancreatic duct to be treated. These devices can be used to open narrowed or blocked ducts, remove and / or crush gallstones as part of a lithotripsy procedure, perform biopsies, and possibly surgically remove tumors in the duct area or insert stents into the ducts. When using endoscopic retrograde cholangiopancreatography (ERCP) after a papillotomy, gallstones are typically removed using a catch basket. Catch baskets are also suitable for safely removing stone fragments from the bile duct.

[0004] A device for endoscopically removing stones or calculi from the bile duct and pancreatic duct, of the type referred to in the general terms of claim 1, is known from German Patent Application Publication No. 10 2009 031 209. The device includes a cable guided within a tube, a control element disposed at its proximal end for axially moving the cable within the tube, and a catch basket formed from at least four elastic basket wires disposed at its distal end. When the cable is axially moved by the control element, the catch basket is pulled into a loop or expanded as it is pulled toward the distal end of the tube and partially enters its lumen. This catch basket is used to capture gallstones released from the papilla and is constricted while being rotated to capture the gallstones. Gallstones captured between the basket wires are fixed within the catcher basket and can be removed from the bile duct and pancreatic duct.

[0005] A significant problem always arises when the size of a stone makes it impossible to extract and remove it through a bodily opening, such as the bile duct. Forcibly removing the stone would cause significant damage to the patient undergoing the procedure. The only options to address this problem are to apply force to the stone via a catch basket to perform lithotripsy, or to design a catch basket so that it can be actuated via an endoscopic device to release the stone, and the device can be removed from the bile duct after the catch basket has separated from the stone.

[0006] Furthermore, German Patent Application Publication No. 32 16 178 discloses a device for mechanical lithotripsy and removal of stones formed in the bile duct. This device consists of an extractor, which can be combined with a lithotripsy device if necessary. The extractor has a control device in the form of a handle, which is connected to a push rod and a sleeve that holds the push rod. The push rod is telescopically guided within the sleeve, and its end remote from the handle is fixed to a pull cable, which is connected to a stone retrieval basket. As a result, when the push rod moves axially within the sleeve, the stone retrieval basket opens or closes depending on the direction of movement. For example, stones present in the bile duct can be picked up by the stone retrieval basket and removed from the patient's body by moving the entire device proximally.

[0007] According to German Patent Application 32 16 178, in addition to the extractor, a separate lithotriptor is provided that can be attached to the operating element if necessary. This tensioning element has a radially extending bracket. After the lithotriptor is attached, the bracket engages with the handle of the first operating element on the one hand and with a headpiece connected to the sleeve on the other hand. If it is determined that the stone is too large to be easily removed, the lithotriptor attached to the operating element applies a strong tensile force to the cable, causing the stone in the quarry basket to break into several small fragments. These fragments can then be removed along with the quarry basket. Summary of the Invention [Problem to be solved by the invention]

[0008] The object of the present invention is to improve a device for endoscopic removal of stones or calculi from the bile and pancreatic ducts in such a way that more favorable possibilities arise with regard to the necessary lithotripsy. [Means for solving the problem]

[0009] This problem is solved on the basis of the general terms of the claim with the characteristic features. The claims dependent on claim 1 contain further embodiments of this solution according to the invention.

[0010] As a result, a device for endoscopic removal of stones or calculi from the bile duct and pancreatic duct is provided. The device includes a control wire guided within a tube. A control element for axially moving the control wire is attached to the proximal end of the control wire, which passes through the tube, while a catch basket made of a basket wire is attached to the distal end of the control wire. Axial movement of the control wire by the control element expands or contracts the catch basket in a loop shape. Thus, the control element can be used to perform precise movements to capture, safely contain, and remove the stone.

[0011] According to the present invention, the control wire should be separable from the control element and connectable to an actuation element capable of exerting sufficient force on the catch basket to perform lithotripsy on the stone contained by the catch basket. As already explained, if a stone picked up by the catch basket has dimensions that prevent its removal from the bile duct, the stone requires lithotripsy. This can be achieved by applying force to the catch basket holding the stone, which is partially retracted into the lumen of the tube via the control wire, thereby narrowing the catch basket. As a result, the stone fragmented by mechanical lithotripsy is broken into multiple stone fragments that remain in the catch basket.

[0012] The control element acting on the control wire preferably has a thumb ring and two finger rings as a slider for one-handed operation, but it is not possible to apply the necessary tension. In the solution according to the invention, the control element is replaced by an actuating element suitable for the following lithotripsy. For this purpose, the control element is separated from the control wire, which is then coupled to the actuating element.

[0013] In contrast, according to the general German published patent application 10 2009 031 209, an endoscopic device is intended for removing gallstones by means of a catch basket, but mechanical lithotripsy is not performed with this device, since the control element is only intended to effect movement to expand and contract the catch basket. Therefore, the control element provided on the device cannot be used to generate the tensile forces on the catch basket required for mechanical lithotripsy.

[0014] Further prior art, German Published Patent Application No. 32 16 178, provides another lithotriptor, which, if necessary, must be fixed to a control element, thereby enabling a sufficient tension force to be applied to the control wire. However, this lithotriptor is not suitable for combination with all types of control elements. In particular, this lithotriptor cannot be combined with conventional control elements that can be operated with one hand and have a thumb ring and two finger rings.

[0015] The actuating element should be designed and dimensioned to apply a maximum tensile force of 500 N for lithotripsy of stones collected by the catch basket. This high tensile force must generate enough force in the catch basket to crush the stones, but must not cause plastic deformation or embrittlement of the actuating element. A tensile force of 200 N is required to crush a gallstone approximately 1 cm in diameter.

[0016] In a further embodiment of the invention, the traction means extends from the actuation element and is connectable to the control wire by a form-fitting connection, so that the control wire, which is separated from the control element, is connected to the traction means in a form-fitting manner. The mating of the two components, the traction means and the control wire, creates a form-fitting connection that acts in the direction of the pulling force.

[0017] In a further embodiment of the invention, the form-fitting connection should be designed as a hook-and-eyelet connection, where a hook preferably formed on the control wire is hooked onto the distal eyelet of the traction means, thus transmitting the high tensile forces generated by the actuation element using simple means.

[0018] It is further contemplated that after separation from the control element, the proximal end of the control wire can be provided with a kink, with the kink extending generally parallel to the control wire, which acts as a hook for a form-fitting connection with the eyelet and can provide a means for preventing the hook from disengaging from the eyelet under high tensile forces.

[0019] Furthermore, means for fixing the kink should interact with the proximal end. These means prevent the kink from bending open under the high tensile forces transmitted to the kink by the eyelet. These means are preferably created by drawing the proximal end of the control wire, which is threaded through the eyelet of the traction means, into the lumen of the metallic helical tube, thereby reliably preventing the kink from bending open. The diameter of the lumen formed in the helical hose is dimensioned so that, on the one hand, the proximal part can be drawn in and moved within it, and, on the other hand, so that a radially acting tension acts on the bent proximal end that receives the eyelet, thereby making it possible to transmit high tensile forces through this connection.

[0020] The actuation element is also provided with a shaft extending in the same longitudinal direction as the traction means, on which a tensioning device extending transversely to the shaft is rotatably mounted, through which the proximal end of the traction means is threaded. The proximal end of the traction means, designed as a wire or cable, is wound around the tensioning device, designed as a spool, by the practitioner manually applying a rotational movement to the tensioning device.

[0021] In a further embodiment of the device according to the invention, the kink in the proximal end of the control wire can be produced by a tool with two tool parts that undergo angular movement relative to each other. According to a first embodiment, the tool can have two legs connected to each other via a hinge, and the control wire can be fixed to one of the legs. The legs are preferably designed as flat plastic parts connected to each other via a hinge at one end.

[0022] According to a second embodiment, the tool may also have an annular base having a holding grip within which the disc is rotatably guided, with the proximal end being inserted radially through an insertion opening in the base into both the base and the adjacent driver of the disc, such that when the disc is rotated relative to the base, the proximal end is deformed into a hook shape.

[0023] Additionally, a tool having hinged legs may have aligned grooves for receiving control wires, and at least one leg may have a clamp for securing the control wire.

[0024] Furthermore, the problem underlying the present invention is also solved in the context of a method for converting a device placed in the working channel of a medical endoscope and used after endoscopic retrograde cholangiopancreatography, which is used for lithotripsy and removal of stones trapped by a catch basket, and which comprises a tube, a control wire guided within the tube, a catch basket distally connected to the control wire for accommodating the stone, and a control element engaging the tube and the control wire, the catch basket being expanded or contracted into a loop by axial movement of the control wire by the control element.

[0025] According to the present invention, the following process steps are provided: severing a proximal portion of a control wire guided within a guide shaft of a control element; bending the proximal end of the control wire to form a hook-like configuration; - hooking the hook-shaped proximal end of the control wire onto the eyelet of the traction means of the actuation element used in lithotripsy; applying tension to the actuation element to longitudinally move the hooked end of the control wire and the eyelet of the traction means into the metal spiral hose; Applying additional tension to the actuation element to apply force to the catch basket and crush the stones picked up by the catch basket.

[0026] As part of this method, after the kinked end is hooked, the kinked end can first be manually pulled proximally until the eyelet contacts the distal end of the spiral hose. The proximal end of the traction means is then connected to a tensioning device arranged on the actuation element, and tension is applied to the traction means via the tensioning device, designed as a take-up spool, until the eyelet is forced into the spiral hose. Further actuation of the tensioning device then increases the tension transmitted to the control wire, retracting the catch basket until it moves to the distal end of the tube. Finally, further increasing the tension breaks down the stones trapped in the catch basket.

[0027] The present invention is not limited to the specified combinations of the features of independent claim 1 and the dependent claims and of process claim 9 and the dependent claim 10. Furthermore, there are further possibilities of combining individual features with one another, especially if these arise from the claims, the advantages stated in connection with them, the description of the embodiments below, or directly from the drawings. Furthermore, the reference in the claims to the drawings by the use of reference signs is in no way intended to limit the scope of protection of the claims to the example embodiments shown.

[0028] Further features of the invention will become apparent from the following description and from the drawings, in which simplified embodiments of the invention are shown. [Brief explanation of the drawings]

[0029] [Figure 1] 1 shows a perspective side view of the control elements of a device for endoscopic removal of stones or calculi from the bile and pancreatic ducts, with only a portion of the tubing visible. [Figure 2] 10 shows a side view of the distal end of a control wire with a catch basket attached. [Figure 3] This shows how, during a medical endoscopic procedure on a patient, it was determined that a stone picked up by the catch basket needed to be lithotripted with considerable force, and then the control element was separated from the control wire using a side cutter. [Figure 4] 10 shows the proximal end of the control wire inserted into a tool used to bend the end of the control wire into a hook shape. [Figure 5] 10 shows the proximal end of the control wire bent into a hook. [Figure 6] The drawing shows a towing means disposed within a metal spiral hose, with an eyelet formed at its distal end and coupled to a hook via the eyelet. [Figure 7] 1 shows a lithotripsy working element to which the proximal end of the traction means is attached. [Figure 8] 5 shows the tool used in accordance with FIG. 4 to bend the proximal end of the control wire, ready for insertion of the control wire. [Figure 9] The tool of FIG. 8 is shown in a closed position with bending of the control wires being performed. [Figure 10] 10 shows another embodiment of a tool for bending control wires. [Figure 11] The actuation elements used are shown in FIG. DETAILED DESCRIPTION OF THE INVENTION

[0030] In Figure 1, 1 denotes a control element from which extends a tube 2 and a control wire 3. The control wire 3 extends within the lumen of the tube 2, not shown in detail, and can be seen in Figure 2. The control element 1 has a slider 4, which is connected to the proximal end of the control wire 3 and is guided within a longitudinal slot of a guide shaft 5, not shown in detail. This guide shaft 5 is further rigidly connected to the tube 2, such that relative movement of the slider 4 with respect to the guide shaft 5 allows the control wire 3 to be moved back and forth within the tube 2. To achieve these movements, the guide shaft 5 is provided with a thumb ring 6, and the slider has two finger rings 7.

[0031] 2 shows the distal end of the control wire 3 when not covered by the tube 2, with a catch basket 8 fixed to this distal end. The basket wire 9 of this catch basket 8, which is in an open state in the figure, is bound at one end to the end of the control wire 3 and at the other end to a cartridge-like guide element 10 which forms the distal end of the catch basket 8.

[0032] The tube 2, together with the control wire 3 and catch basket 8, is preferably inserted into a working channel (not shown) of a medical endoscope that extends through the patient's pharynx, esophagus, and stomach to the area of ​​the patient's bile duct and pancreatic duct. Here, the catch basket 8 is initially in a closed position, in which it is completely contained by the tube 2. A guide wire, preferably inserted into the second lumen of the tube 2 via a guide wire, is inserted into a body opening and extended under endoscopic or radiographic observation to the area where the stone is present. This allows the tube 2, containing the guide wire 3 and catch basket 8, to be guided to the area.

[0033] Next, the catch basket 8 is actuated via the control element 1 to the open state shown in FIG. 2, which is due to the inherent tension of the catch basket 8. In this open position, the open catch basket 8, positioned by the control element 1, can pick up the stone. Preferably, the catch basket 8 undergoes a rotational movement during stone pick-up and subsequent closing by the control element 1, during which the catch basket 8 is supported at the distal end of the tube 2, facilitating stone pick-up. During the subsequent pulling movement of the control wire 3, which is moved relative to the tube 2, the catch basket 8 contracts tightly around and surrounds the stone, so that it can be passed through the corresponding body opening, supported within the catch basket 8 by the control wire 3 and the tube 2, for safe removal.

[0034] However, a serious problem arises when the stone is too large to be extracted through a bodily opening such as a bile duct. Forcibly extracting the stone would cause significant trauma to the patient undergoing the procedure. However, even with the control element 1, which is primarily suited to locating and picking up stones, it is not possible to transmit sufficient traction force to the catch basket 8 via the control wire 3 to crush the stone. Therefore, the only option left is to release the stone by opening the catch basket 8 via a release device provided on the catch basket 8. However, in order to pick up the stone in the basket of another lithotriptor, the aforementioned process must be repeated.

[0035] According to the present invention, when lithotripsy of a stone too large for normal removal is required, the tube 2 and control wire 3 are proximally separated from the control element 1 by side cutters 11, as shown in Figure 3. The control wire 3 is separated so that its proximal end 13 protrudes axially beyond the proximal end of the tube 2. As can be seen in Figure 4, this protruding end 13 of the control wire 3 is inserted into a tool 12 and secured to this tool 12, as will be described in more detail below in connection with Figure 8. The proximal end 13, shown in Figure 5, is bent into the shape of a hook using the tool 12, thereby forming a kink 13a in the proximal end 13.

[0036] As shown in Figure 6, the hooked end 13 is provided on the distal side of the traction means 14, which is designed as a wire or cable, and is hooked onto an eyelet 15 having a diamond-shaped outer contour. The traction means 14 extends into the lumen 16 of a metallic spiral tube 17, which is arranged inside a tube 18. The diamond-shaped outer contour of the eyelet 15 ensures that the hooked end of the control wire 3 hooked onto the eyelet 15 is caught in the sharp angled region 19 on the distal side of the eyelet 15, and that the eyelet wire 20 is pulled radially when the eyelet 15 is retracted into the lumen 16.

[0037] 7, the traction means 14 is manually pulled in the proximal direction and hooked onto the tensioning device 21 of the actuation element 22. The tensioning device 21 extends perpendicularly to the handle part 23 of the actuation element 22 and is rotatably attached to the actuation element 22. In this way, when the tensioning device 21 is manually actuated so as to perform a rotational movement relative to the handle part 23, this causes the traction means 14 to be wound up on a corresponding design part of the tensioning device 21.

[0038] As a result, the eyelet 15 protruding from the distal end of the tube 18, together with the proximal end 13 of the control wire 3 hooked to the eyelet 15, is pulled into the lumen 16 of the helical tube 17, as shown in Figure 6. This causes an increase in tensile force in both the traction means 14 and the control wire 3 connected to the traction means 14, and this force is transmitted to the catch basket 8 for lithotripsy of the corresponding stone.

[0039] The other figures 8 and 9 show different perspective views of the tool 12 used to bend the control wire 3, the function of which has already been explained in relation to figure 4. The tool 12 consists of two legs 24 and 25 which are guided pivotally relative to one another and connected to one another via hinges 26 and 27. In figure 8, the tool 12 is in an open state and surfaces 28 and 29 of the two legs 24 and 25 are visible, which are guided along the hinges 26 and 27 and moved towards one another when the control wire 3 is bent.

[0040] Surfaces 28 and 29 of legs 24 and 25 have aligned grooves 30 and 31 into which control wire 3 is inserted prior to the bending process. Control wire 3 is then held in position in the two grooves 30 and 31 by spring plate 32 on leg 24 and clamp 33 located on leg 25. Tool 12 is then folded as shown in FIG. 9, and proximal end 13 of control wire 3 housed by tool 12 is deformed into the hook-like configuration shown in FIG. 5.

[0041] 10 shows another embodiment of a tool 34, consisting of an annular base 36 provided with a handle 35 and a disk 37 rotatably guided therein. In this case, the proximal end 13 shown in FIG. 4 is inserted through an insertion opening 38 in the base 36 and into adjacent channels (not shown in detail) in the disk 37.

[0042] This is done with the disc 37 in the position indicated by the arrow 39 pointing to the "Start" mark relative to the base 36. The actuating lever 40 on the disc 37 is then used to rotate it clockwise from this position to the end position defined by the end stops 41 and 42. This causes a bend in the inserted control wire 3 that is guided between the base 36 and the disc 37.

[0043] Finally, Figure 11 shows the actuation element 22 already described in relation to Figure 7, with the tensioning device 21 to which the traction means 14 is attached. When a knurled handle 43 formed on the tensioning device 21 and extending at a right angle to the shaft 44 is rotated, this causes the traction means 14 to move proximally within the tube 18, with the result that the eyelet 15 protruding beyond the distal end of the tube is retracted into the helical tube 17 arranged within the tube 18. [Explanation of symbols]

[0044] 1. Control Elements 2 tubes 3 control wires 4 Slider from 1 5 Guide shaft from 1 Thumb ring from 6 1 7 Finger Rings from 1 8 Catch Basket Basket wire from 9 8 Cartridge-like guide elements from 10 8 11 Side cutter 12 Tools Proximal end of 133 13a 13 Kink 14 Traction means 15 eyelets 16 lumen 17 Spiral Hose 18 tubes 19 15 distal acute angle area 20 Eyelet Wire 21 Tensioning device 22 Actuating Elements 23 Handle 24, 25 legs 26, 27 Hinge 28 24 Regions 29 5th Area 30 28 grooves 31 29 groove 32 Spring Plate 33 Clamp 34 Tools 35 Handle 36 Base 37 discs 38 Insertion port 39 Arrow 40 Operating lever End stop on 41 37 42 36 top end stop 43 Handle part from 21 Shaft from 44 22

Claims

1. An apparatus for endoscopic removal of stones or calculi from the biliary tract and pancreatic duct, comprising: a control wire (3) guided within a tube (2), a control element (1) for axially moving the control wire (3) within the tube (2) at a proximal end of the control wire (3), a catch basket (8) made of a basket wire (9) fixed to a distal end of the control wire (3), the catch basket (8) being expanded or contracted in a loop shape by the axial movement of the control wire (3) by the control element (1), the control wire (3) being separable from the control element (1) and connectable to an actuating element (22) for lithotripsy of the stone contained in the catch basket (8), and the actuating element (22) being capable of generating a sufficient force on the catch basket (8); a traction means (14) extending from said actuation element (22) and connectable to said control wire (3) by a form-fitting connection; and characterised in that the form-fitting connection is designed as a hook (13)-eyelet (15) connection; A device for endoscopic removal of stones or calculi from the biliary and pancreatic ducts.

2. 2. The device according to claim 1, characterized in that after separation from the control element (1), a kink (13a) is provided at the proximal end (13) of the control wire (3), and the bent proximal end (13) extends at an acute angle or parallel to the control wire (3).

3. 3. A device according to claim 2, characterized in that the means for fixing the kink (13a) interact with the proximal end (13).

4. The device according to claim 2, characterized in that the proximal end (13) of the control wire (3), which is hung on the eyelet (15) of the traction means (14), is pulled together with the eyelet (15) into the inner cavity (16) of a metallic spiral tube (17), and functions as a fixing means for the kink (13a).

5. An apparatus for removing stones or calculi from the biliary tract and pancreatic duct by endoscopy, comprising: a control wire (3) guided within a tube (2), a control element (1) for axially moving the control wire (3) within the tube (2) at a proximal end of the control wire (3), a catch basket (8) made of a basket wire (9) fixed to a distal end of the control wire (3), the catch basket (8) being expanded or contracted in a loop shape by the axial movement of the control wire (3) by the control element (1), the control wire (3) being separable from the control element (1) and connectable to an actuating element (22) for lithotripsy of the stone contained in the catch basket (8), and the actuating element (22) being capable of generating a sufficient force on the catch basket (8); a traction means (14) extending from said actuation element (22) and connectable to said control wire (3) by a form-fitting connection; and the actuating element (22) has a shaft (44) extending in the same longitudinal direction as the traction means (14), and a tensioning device (21) extending transversely to the shaft (44) and rotatably mounted thereon, the proximal end of the traction means (14) being able to be hooked into the tensioning device (21), A device for endoscopic removal of stones or calculi from the biliary and pancreatic ducts.

6. 3. The device according to claim 2, characterized in that the kink (13a) of the proximal end (13) of the control wire (3) can be made by a tool (12, 34) having two tool parts (24 and 25, 36 and 37) that undergo angular movement relative to each other.

7. 7. The device according to claim 6, characterized in that the tool part is designed as two legs (24 and 25) connected to each other via a hinge, and the control wire (3) can be fixed to one of the legs (24).

8. 8. The device according to claim 7, wherein the legs (24 and 25) have aligned grooves (30 and 31) for accommodating the control wire (3), and at least one of the legs (30, 31) is provided with a clamp (32, 33) for securing the control wire (3).

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