DE8626340U1 - Instrument for breaking up concretions in hollow organs - Google Patents

Description

Instrument for breaking up concretions in hollow organs

The invention is based on the problem of breaking up concretions in hollow organs; in particular, it deals with endoscopic, retrograde lithotripsy of bile duct or urinary stones, for which various methods are already known.

The known methods have in common that a lithotriptor is brought closer to the calculus to be broken up in the opposite direction to its natural exit. For this purpose, the lithotriptor is usually introduced through an endoscope.

For example, to remove gallstones or bile duct stones that are stuck in the bile duct, a duodenoscope is pushed through the duodenal papilla, the junction of the main bile duct and the duodenum, to the bile duct stone that is to be crushed, which is then subjected to the action of the lithotriptor that is inserted through the instrument channel of the endo- or duodenoscope. The energy required for crushing is supplied to the calculus through an energy conductor that runs in the lithotriptor. After crushing, the fragments of the calculus usually have to be removed using mechanical means, such as baskets or grippers, which are part of the lithotriptor.

The most common method of lithotripsy that can be applied in this way is electrohydraulic lithotripsy, a transfer of any form of energy, such as mechanical (ultrasound,

ect,) and laser line energy via flexible energy filters.

?,'.: Another common method is 'mechanical' lithotripsy. The stone, which is also placed in a basket, is
by pulling on the basket wire and using an over-cut

3D spiral wire spring as abutment, cut from outside to inside.

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Very hard stones cannot be broken up with the mechanical lithotriptor, or can only be broken up with great effort. Only stones that can be caught with the basket can be broken up, as the concretion is broken up by cutting into the wire loops of the basket. However, it is not possible to catch the stone in all cases. Lithotripsy in an excretory duct cannot normally be carried out under vision, but can only be controlled indirectly using contrast medium in the X-ray image. The energy required for breaking up the stone must therefore be transferred to the stone without direct vision so reliably that damage to the surrounding tissue can be ruled out.

In electrohydraulic lithotripsy, the probe used is placed parallel to the basket that holds the stone. There is a risk that the energy will be applied tangentially past the stone onto the duct epithelium.

j If the duct mucosa is affected in this way,

) can cause demonstrable damage or even perforations.

I, 20 In addition, the probe required here is too large to be inserted directly through the channel of the endoscope, for example into the bile duct.

j -promote.

&iacgr; As a therapeutic approach that does not require major surgical intervention

requires, the percutaneous transhepatic irradiation of a gallstone with laser light from a continuous wave laser has become known - laser lithotripsy - in which the calculus

not addressed retrogradely, but directly. This mechanism

'· method has the disadvantage that an artificial access through the

The skin must be opened. The risk of tissue injury is high and the lithotomycosis effect is only unsatisfactory.

The invention is based on the task of improving the known lithotriptors in such a way that a safe, targeted and effective introduction of energy by endoscopic-retrograde means is possible even in the case of concretions which cannot be removed with a basket, e.g. in the case of impacted, lumen-filling stones, under X-ray control and also with

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Laser light is possible. This problem is solved according to the invention in an instrument according to the generic term of patent claim 1 by combining all features according to this patent claim*

The instrument according to the invention ensures a safe, targeted application of energy to the concretion because the energy conductor is inserted centrally into the basket or gripper and pushed forward and thus placed vertically on the stone. This makes it possible to

&Iacgr;° Ability to crush stones that cannot be approached with a mechanical lithotriptor* Through the central energy application, which is possible by fixing the stone with the basket or the gripper, which also allows lumen-filling concretions to be fixed

"'S, the surrounding tissue cannot be affected and the entire energy is transferred to the calculus. Consequently, a simple X-ray control is sufficient to carry out the method, even when using a light guide for the application of laser light, although only the metal basket or gripper, but not the glass fiber tip of the light guide, can be shown in the X-ray image. In addition to laser light, other types of energy, such as electrohydraulic or ultrasound energy, can also be transferred to a calculus in an advantageous manner using an instrument according to the invention according to the principle of central energy application. The path of endoscopic-retrograde laser lithotripsy opened up by the invention, which, in contrast to percutaneous-transhepatic laser therapy, spares the patient the opening of an access through the abdominal wall, is possible because the light guide required for this is stored within the instrument and is so flexible that it can be used with the help of the Albarran lever at the tip of the endoscope, especially the duodenoscope, which can be bent by 90° to allow a sharp change in direction, e.g. when passing from the duodenum into the common bile duct, without damaging the instrument

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or impair its function. This property and the dimensions of the laser lithotripter also allow it to be inserted through a standard endoscope.

To extend the energy conductor and to influence the device for fixing the calculus in the direction of the energy conductor, metal wires and/or tensile hoses made of polytetrafluoroethylene or a material with comparable suitability are used in the instrument according to the invention. An essential development of the invention consists in the fact that adjustable stop devices are provided at the proximal end of the lithotriptor, by means of which the* scope for the operation of these wires or hoses can be limited in such a way that the energy conductor cannot pass through the calculus and be pushed further into the surrounding tissue in an uncontrolled manner, so that the energy application, which is particularly important for the effectiveness of laser lithotripsy, can be concentrated in the center of the stone and that when the energy conductor is returned, it is not accidentally pulled back into the lithotriptor and damaged by the release of energy. The precise adjustability associated with these adjustable stop devices is also another factor that makes X-ray control sufficient for the application of a laser lithotripter according to the invention.

The invention is explained below in the form of embodiments with reference to the schematic figures 1 to 12. In order not to burden the illustration with additional details, laser lithotriptors are assumed throughout as embodiments; the applicability of the principle of central energy application with the instrument according to the invention when using other types of fragmentation energy is not affected by this.
In detail

Fig. 1 shows the distal end of a laser lithotriptor with basket;

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Fig. 2 shows the distal end of a laserithotripter with noise reduction;

Fig. 3 shows a laser lithotripter that is to be inserted as a probe on a guide wire after preparation through an endoscope;

Fig. 4 to 8 show various ways of guiding the light guide and basket or gripper; Fig. 9 and 10 show the design of adjustable stop devices on the handle of a laser iithotriptor; Fig. 11 shows the design of a swivel joint for the pull wire attachment;

Fig.12 shows the procedure for inserting a probe according to Fig.3.

The laser lithotripter according to Fig. 1 is constructed similarly to a common stone catcher (Dormia basket). Like this, it consists of a handle (see Fig. 9) in which the pull wire 1a for the basket 12a is attached. The pull wire runs through an approximately 2m long outer tube 4a made of polytetrafluoroethylene or a material of comparable suitability, which has a maximum outer diameter of approximately 3.2mm. Four strands 11a made of elastic, pre-tensioned wire forming the basket 12a are soldered to the distal end of the pull wire 1a and to each other via a sleeve 2a. The basket 12a can be extended and unfolded from the tube 4a by operating the handle (see Fig. 9). At the distal end of the tube 4a, a guide sleeve 9a, preferably made of brass, is inserted into the tube 4a, which ensures that the light guide 7a exits safely into the center of the basket 12a. The approximately 9mm long sleeve 9a has an axial bore 5a of approximately 1mm diameter. At the front end, an M1 thread is cut into the bore 5a in order to screw on another, inner tube 3a made of polytetrafluoroethylene or a material of comparable suitability and thus fix it to the guide sleeve 9a. The light guide 7a thus runs through the thin tube 3a directly into the bore 5a.

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the guide sleeve 9a and further ⁴ into the center of the basket 12a.

Four grooves 6a, approximately 0.4 mm deep and offset by 90°, are milled into the surface of the sleeve 9a, which accommodate the strands 11a of the basket 12a and in which they can be pushed forwards*· and backwards*

The ¹ handle (Fig.9) consists of the following parts:
A small plastic piece 26 is connected to the stone catching handle 25, to which a connection piece 28 for water flushing or contrast medium injection and a plastic arm 20 with a hole for the introduction and holding of the light guide tube 29 are attached. The handle 25 is sealed against water by a silicone disk 22. A metal Y-pipe 30 is connected to the attachment piece 26. The leg 30a of this pipe closest to the handle contains the pull wire 21. The water for flushing is also guided into the adjoining outer hose 24 via this leg.
An inner tube 23 is drawn into the leg 30b of the Y-tube up to its conical end, which tube accommodates the light guide 27.

In the tube leg 30c, the pull wire 21, water flush, inner tube 23 and light guide 27 are brought together at the distal end, to which the outer tube 24 of the laser lithotriptor is connected.

The light guide tube 29, which is held on the handle 25 via the plastic arm 20, contains a thinner tube 31 which is provided with an external thread. The tube 31 can be pushed back and forth within the range limited by the adjustment of the stop nuts 32a and 32b. This movement is followed by the light guide 27, which is fixed to the tube 31 via the clamping piece 33.
The laser lithotriptor is operated as follows:
- The concretion is first measured radiologically.

- To avoid extending the light guide further than the centre of the

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In order to advance the stone RS, a displacement range corresponding to half the diameter of the stone is now set using the nuts 32a and 32b on the movable part 31 of the light guide tube.

- The stop nut 32b is adjusted so that the tip 8a of the light guide 7a just ends with the distal end of the tube 4a.

- With the light guide 7a retracted, the laser lithotripter is inserted into the endoscope.

_ _Now the stone is caught as with a conventional stone catcher, gently pressed against the end of the hose 4a by pulling on the handle 25 through the basket 12a ff and thus fixed.

- The light guide 7a can now be advanced so that the stripped light guide tip 8a is perpendicular to the [

stone surface. J

- During the laser process, the glass fiber 8a is guided to the j

Stop pushed into the interior of the stone and after

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- Now you can use the laser lithotriptor like a normal §

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m The laser lithotriptor with gripper according to Fig.2 is similar in principle to |-

V zip the basket lithotriptor according to Fig.1. f

The pull wire 1a is replaced by a tensile-resistant hose 3b made of polytetrafluoroethylene or a material with comparable suitability, which also serves as the inner hose that guides the light guide 7b. A guide sleeve 9b with an internal thread is screwed onto the hose 3b so that approx. 15mm of the hose protrudes distally from the sleeve 9b. Three elastic, pre-tensioned flat wires are soldered onto the sleeve 9b as gripping wires 11b, each offset by 120°, the ends of which are bent into <;ü\n 12b. The flat wires are covered with shrink tubing 13b.

3S which protects the surrounding tissue from injury ,

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The light guide 7b can be pushed back and forth within the tube 3b; it emerges centrally between the gripper arms 11b. By pulling on the tube 3b, the gripper can be completely inserted into the outer tube 4b. The inner tube 43 is clamped in the associated handle 45 (Fig. 10) with the clamping piece 42. In order not to crush the tube, a sleeve 48 is provided at this point. The tube 46 connected to the handle 45 is provided with a stop device consisting of the clamping piece 53 with clamping screw 53a, the stop nut 52 and the tube 46. In the same way as with the handle 25 of the basket lithotriptor (Fig. 9), the light guide 47 can now be fixed with the clamping piece 53 and, after adjusting the stop nut 52, can only be pushed forward to a certain point.

,When the light guide is retracted, the stop occurs when the tube 49 is completely pulled out of the guide tube 46.

In Fig. 11, a swivel joint is shown for fixing the pull wire at the handle end of a basket lithotriptor according to Figs. 1 and 9, with which tensions are avoided or compensated for, which arise from twisting the pull wire within the outer tube of the lithotriptor. A torque of the pull wire la would cause the basket strands 11a to twist in front of and behind the guide sleeve 9a. If the strands 11a are twisted, the basket can no longer be extended and retracted properly.

To prevent this, an angle plate 34 is attached to the end ¹ of the handle tube 25 (see Fig. 9) by means of a screw 37, which is provided with a guide slot for receiving a metal button 35 for fixing the pull wire 27 by means of the clamping screw 36. The button 35 is mounted in the guide slot of the angle plate 34 so that it can rotate but cannot be moved axially, thus allowing a degree of freedom for the rotation of the pull wire 27.

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Laser lithotriptors according to Fig. 1 and 2 are operated with a flash lamp pulsed Nd-YAG laser, whereby the light guide must have direct contact with the calculus. In addition, according to the invention, lasers with resonator quality-controlled pulse generation or Q-switched lasers, in particular Nd-YAG lasers, can also be used with instruments of comparable construction. With these Q-switched lasers, lithotription is carried out without contact with the stone, ie it is not absolutely necessary to advance the light guide within the lithotriptor. Instead, a focusing optic must be attached to the tip of the light guide. Lithotriptors designed accordingly are described with reference to Fig. 3 to 8.
Fig.3 shows a Q-switched laser lithotripter in the form of a probe, which is used when the lithotripter cannot be inserted directly through an endoscope. The guide piece 9c, preferably made of brass, is firmly connected to the light guide 7c inserted into the bore 15c, and this is coupled within the guide piece to the focusing optics integrated in the latter, not shown in the figure. Two cannula tubes 6c lying opposite one another are soldered to the guide piece 9c; see the partial drawing in Fig.3 showing a cross-section through the instrument. The four wire strands forming the basket 12c are threaded in pairs through the tubes 6c and each connected to a pull wire 17c, which is guided in a hose 16c made of polytetrafluoroethylene or a material of comparable suitability that is connected to the respective tube; the tubes 16c and the pull wires 17c are only shown simply in the figure.

Two further tubes, 14c and 18c, are soldered to the guide piece 9c, offset by 90° from the tubes 6c. The latter is only visible in the cross-sectional drawing. The tube 18c is part of the water flush and as such is connected to the hose 19c, which is made of polytetrafluoroethylene or a material of comparable suitability and serves as a water supply line.

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serves. Flat grooves are milled into the guide piece 9c to accommodate the tubes 6c, 9c, 14c and 18c. The PVC hose 4c pulled onto the guide piece 9c accommodates the light guide 7c, the hoses 16c with the pull wires 17c and the water supply line 19c.

The introduction of the probe according to Fig.3 is shown in Fig.12 in the form of four phases of its course: Phase (1): A guide wire "~d" is inserted through the instrument channel ^{of the} endoscope En through the gastrointestinal passage MD to the duodenal papilla up to

the bile duct Gg with the stone St retained in it.

Phase (2): The endoscope is removed again, the guide wire Fd remains in place.

Phase (3): The guide wire Fd is threaded through the tube 14c (Fig.3) of the probe So, and the probe So is advanced along the guide wire Fd into the bile duct Gg.

Phase (4): The guide wire Fd is removed.

The probe is now fixed in situ by the tube 4c. The basket 12c is actuated via the pull wires 17c in the manner described in Fig. 1 and 9. Fig. 4 to 8 show further developments of the kinematics of the light guide and basket or gripper in Q-switched laser lithotripsy.

Fig.4 : A probe that can be inserted through an endoscope depending on its size, with a guide piece 9do that is firmly connected to the light guide 7d and in which a focusing optic is integrated. Four grooves 6d are milled into the guide piece 9do, in which the wire strands of the basket 12d are guided. The guide piece 9do is firmly connected to the hose 4d made of polytetrafluoroethylene or a material of comparable suitability that is pulled onto it. The basket 12d can be extended or retracted by pulling or pushing on the pull wire 1d.

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Fig. 5 i A probe which can be inserted through an endoscope depending on its circumference, with a guide piece 9e to which three or four basket supports 11e are soldered distributed over its circumference. The guide piece 9e is screwed to a tensile-resistant tube 18e made of polytetrafluoroethylene or a material of comparable suitability. The light guide 7e is firmly connected to the focusing optics 9e-o, which can be extended or retracted by means of the light guide 7e in relation to the tube 4e made of polytetrafluoroethylene or a material of comparable suitability. The guide piece 9e can be moved by means of the tube 18e in the front end of the tube 4e. When it emerges from the tube 4e, the basket 12e unfolds.
Fig.6 i A probe in a similar design to the probe in Fig.3. The focusing optics are integrated in the guide piece 9fo which is firmly connected to the light guide 7f. The stranded wires 11f of the basket 12f are guided in cannula tubes 6f. The guide piece 9fo is firmly connected to the hose 4f pulled onto it. The basket 12f can be extended or retracted by pulling or pushing the pull wire 1f. Fig.7 : A probe with a gripper which can be inserted through an endoscope depending on its circumference, the gripper arms 12h of which are soldered onto the guide piece 9ho. The guide piece 9ho, which is firmly connected to the light guide 7h and contains the focusing optics, can be moved in the outer hose 4h. The light guide 7h is located in a tensile-resistant hose 21h made of polytetrafluoroethylene or a material of comparable suitability, by means of which it can be extended and retracted together with the guide piece 9ho in relation to the hose 4h. When it is extended from the hose 4h, the gripper opens.

Fig.8: A probe that can be inserted through an endoscope with a focusing optic 9i-o that is separate from the guide piece 9i and independent of it. The guide piece 9i with the gripper arms 12i soldered to it at a 120° angle can be moved by means of the tensile-resistant hose 21i that is firmly connected to it, and the fo-

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optics 9i-o can be extended and retracted in relation to the outer tube 4i by means of the light guide 7i firmly connected to it. When the guide piece 9i is extended from the tube 4i, the gripper opens.

Claims (12)

&bgr;&phgr; a · · I lit* ■ 1 «n · · · ■ ti ' ' ·· 86/19974 in s &rgr; r u c_ h e 1. instrument for breaking up concretions in the gallstones, in particular lithotriptor for* erythroscopic, retrograde lithotripsy of bile duct or urinary stones,
characterized by an axially extendable conductor for the crushing energy (energy conductor, Fig. 1:7a; Fig. 2:7b) aimed at the center of the concretion to be crushed and by a device (basket, Fig.1:12a; gripper, i| Fig.2:12b) for fixing the concretion in the target direction of the energy conductor (7a;7b). 2. Instrument according to claim 1, characterized by an energy conductor in the form of a light guide for laser light pulses. 3. Instrument according to one of the claims 1 and 2,
characterized by a basket (Dormia basket, 12a) made of pre-tensioned elastic wire strands (11a) that can be extended from the lithotriptor coaxially to the energy conductor (7a) and unfolds and encloses the concretion (Fig.1) y, 4. Instrument according to one of the_Ea±J3-FHÖ§mSprüche 1 u/id 2, ■«- characterized by a coaxially extending from the lithotriptor to the energy conductor (7b) extendable and expanding gripper (12b) made of pre-tensioned elastic wires L (gripper wires, 11b), whose free ends rest on the calculus p are to be supported (Fig.2). tr - 2 - 86/19974 5. Instrument according to one of claims 2 to 4, characterized by a guide piece (9a; 9b) for guiding the wire strands (11a) or the gripper wires (11b) and the energy conductor (7a; 7b) at the distal end of a tube (4a; 4b) made of polytetrafluoroethylene to be introduced into the endoscope. ethylene or a material of comparable suitability (Fig.1;Fig.2). \ 6. Instrument according to claim 5, i' characterized in that the guide piece (9a) is firmly connected to the L-tube (4a) and the wire strands (11a) ^;: are slidably mounted on the guide piece (Fig.1). \ 7. Instrument according to claim 5, characterized in that the guide piece (9b; 9e; 9i) is displaceable in the hose (4b; 4e; 4i) and the gripper wires (11b; 12i) or the wire strands (11e) are attached to the guide piece (9b; 9e; 9i) (Fig.2; Fig.5; Fig.8). 8. Instrument according to one of claims 2 to 7, characterized in that the light guide (7a; 7b; 7e; 7i) is displaceable in the guide piece (9a; 9b; 9e; 9i) (Fig.1; ''■ Fig.2; Fig.5; Fig.8). 9. Instrument according to one of claims 2 to 8, characterized in that the light guide (7c; 7d; 7e; 7h; 7i) is provided with a focusing optic (9c; 9do; 9e-o; 9fo; 9ho; 9i-o) (Fig.3; Fig.4; Fig.5; Fig.6; Fig.7; Fig.8), 10. Instrument according to one of claims 2 to 9, characterized in that the focusing optics are integrated into the guide piece (Fig.3:9c; Fig.4:9do; Fig.6:9fo; Fig.7:9h0) . It M tt * * till i * KtI If* ·* ' H t I 1 1**1 * # # · t 11 IIJ · 4·4*«&iacgr; *» The MII i* I* * &diams; 86/19974 11. Instrument according to one of claims 2 to 9,
characterized in that the focusing optics (9e-o; 9i-o) and the guide piece (9e; 9i) are displaceable independently of one another (Fig.5; Fig.8). 12. Instrument according to one of claims 1 and 2,
characterized by adjustable stops (32a, 32b) at the handle end of the lithotriptor for limiting the axial displacement of the energy conductor (27; 47) (Fig.9; Fig.10).