CA2996667A1

CA2996667A1 - Device for manipulating foreign bodies in hollow organs (variants)

Info

Publication number: CA2996667A1
Application number: CA2996667A
Authority: CA
Inventors: Vladimir Nikolaevich HACHIN; Stepan Vladimirovich HACHIN
Original assignee: Obschestvo S Ogranichennoy Otvetstvennostyu "smet"
Current assignee: Obschestvo S Ogranichennoy Otvetstvennostyu "smet"
Priority date: 2014-10-31
Filing date: 2015-10-30
Publication date: 2016-05-06
Also published as: WO2016068758A1; RU2014144355A; RU2625780C2; EP3219265B1; EP3219265A1; EP3219265A4

Abstract

The invention relates to medical technology, and more particularly to devices for manipulating foreign bodies in hollow organs. A device comprises a catheter, a guidewire and a foreign body trap, wherein the foreign body trap is connected to the catheter and/or the guidewire, and the guidewire is hollow or solid, and wherein at least one of the parts of the foreign body trap is provided with a mesh surface. In an alternative embodiment, a device for manipulating foreign bodies in hollow organs comprises a catheter, a guidewire and a foreign body trap, wherein the foreign body trap, the catheter and the guidewire are made from a single initial component, and the guidewire is hollow or solid, and wherein at least one of the parts of the foreign body trap is provided with a mesh surface. The invention makes it possible to manipulate foreign bodies more efficiently as a result of an improvement in the extraction properties of the foreign body trap and an increase in the functional capabilities of the device.

Description

=
= Atty. Docket No. 060738.0017 DEVICE FOR MANIPULATING FOREIGN BODIES
IN HOLLOW ORGANS (VARIANTS) FIELD OF THE INVENTION
[0001]
The invention relates to medicine, i.e., to medical instruments for endoscopic surgery, and may be used to extract foreign bodies from hollow and tubular organs, e.g., ureteral calculi, gall stones, thrombi, polyps, and for other manipulations with foreign objects.
BACKGROUND OF THE INVENTION

[0002]
There is known in the art a device for extracting foreign bodies from the body of a human or animal, e.g., ureteral calculi (US2943626, A61B17/22, 1960). The device is known as a Dormia extractor or basket and consists of a catheter (flexible tube) and guide inside the catheter with a basket or snare of elastic elements permanently attached to the distal end of the guide. The guide with basket/snare moves freely inside the catheter. When the basket is retracted into and protracted from the catheter, its radial dimensions decrease and increase accordingly, rendering the basket either in a collapsed transport mode for delivery to the foreign body or in an operating deployed state to capture and remove the foreign body.

[0003] The device has been well known among specialists for almost sixty years and has been used without significant changes in global clinical practice to date.

[0004]
The device's disadvantages are the poor extractive properties of the basket/snare, limited to only one surgical procedure ¨ lithoextraction.
The symmetric construction of the proximal and distal parts of the basket/snare do not provide for the reliable capture and retention of the foreign body during extraction.

= Atty. Docket No. 060738.0017

[0005] The device cannot be used for additional procedures frequently needed during lithoextraction at the surgical site of the foreign body:
drainage of the ureter and kidney, the administration of pain relievers and lubricants, basket lithotripsy, etc.

[0006] There have been numerous attempts to improve the extractive properties of the Dormia basket and to expand the device's surgical capabilities.

[0007] The original device for extracting foreign bodies from physiological channels or channels in the human body proposed by the same author includes two Dormia baskets, one inserted into the other (US4612931, A61B17/22, A61B17/221, 1986). In the inventor's opinion, the device is less injurious, but its extractive properties ¨ the ability to capture, especially a large object, in the inner basket, are even more problematic than in a single-basket snare. The device has no other competitive advantages except a lower injury rate.

[0008] There is known in the art a device for extracting foreign bodies consisting of the same elements: a catheter and guide with a basket/snare on the distal end (US5057114, A61B17/22, 1991). The device differs from the previous one in that there is no tip on the distal end of the basket/snare. The absence of a tip makes it possible to capture small stones at the inferior walls of urinary or gall bladders without damaging the inner walls of the hollow organ. The device, however, does not support the reliable capture of large stones or, if necessary, guaranteed liberation from the foreign body. Furthermore, the device's design does not provide for additional manipulations with the object inside the basket, e.g., lithotripsy of large stones.

[0009] There is known in the art a device for extracting foreign bodies constructed on the same principles as those above and with a similar basket/snare in the form of equally large loops without a tip on the distal end of the guide . .
= Atty. Docket No. 060738.0017 (US5989266, A61B17/22, A61B17/221, 1999). The device is positioned as minimally invasive for capturing and removing uroliths, primarily from calyxes. The device's basket/snare is simple to manufacture and has enhanced radially rigidity (dilation), but has the disadvantages traditional for similar wire designs: unreliable capture and retention of a stone during extraction and the inability to use other instruments for surgical procedures with the foreign object.

[00010]
There is known in the art a surgical extractor, the basket/snare of which, as in all the previous equivalents, is permanently connected to the distal end of the guide, but includes a large number of wire elements in the distal section and a small number of wire elements in the proximal section (US6780193, A61B17/22, 2002). This basket/snare design facilitates the capture of an object through large windows in the proximal section and its reliable retention by a plurality of wire elements in the distal section of the basket/snare. The increased capturing effectiveness of this basket is, however, also its deficiency: it is hard to free the basket from the stone when the need arises. Furthermore, the device's design does not provide the ability to perform other additional procedures in the object's surgical site.

[00011]
There is also known in the art a surgical device for removing foreign objects from a body which has been popular in recent global clinical practice, has significant competitive advantages compared to the devices above and is the closest equivalent used as the prototype for the present invention (US7101380, A61B17/22, 2003). The device's design is traditional: a catheter and guide with basket/snare on the distal end. But the basket/snare of this device is fundamentally different and consists of a plurality of filaments that in the distal section contain loops that intersect, are interwoven so that they form a mesh structure that can retain even small objects, and in the proximal section are twisted to form a structure with large =
= Atty. Docket No. 060738.0017 holes through which even comparatively large objects pass into the basket easily. As a result, the extractive properties of the basket are fairly high.

[00012]
The device's disadvantages are inability to capture objects larger than the lateral holes, which is related to the fixed size of the lateral holes in the proximal section of the basket; the difficulty of releasing the captured object from the snare when the need arises, for example, if the ureter or bile duct has poor patency because of a structure on the stone's evacuation route; the inability to simultaneously perform other manipulations with an object when this is necessary, for example, basket lithotripsy combined with collection and removal of stone fragments, drainage of the kidney and ureter, the administration of pain relievers, lubricants and contrasting materials, the use of angiographic guides and other instruments and procedures at the operating site of the foreign object.
SUMMARY OF THE INVENTION

[00013]
The objective of the invention is to develop a device for the manipulation of foreign objects in hollow organs that would facilitate the capture, fragmentation and retention of the foreign object and its fragments during extraction, regardless of its dimensions and shape and, if necessary, liberation from the object at any stage of its manipulation.

[00014]
The technical result of the invention is an increase in the efficiency of manipulations with a foreign object through an improvement in the extractive properties of the foreign snare and the expanded functional capabilities of the device. This technical result is achieved by the fact that the first embodiment of the device for manipulations with foreign objects in hollow organs consists of a catheter, guide and snare which is connected with the catheter and/or guide, wherein . .
Atty. Docket No. 060738.0017 the guide is hollow or solid, wherein the snare has a mesh surface in at least one of the parts of the snare.

[00015] The snare may be connected to the catheter and/or guide through a detachable and/or nondetachable connection, wherein the detachable connection is made using, for example, a thread, catch, hook, or grip, and the nondetachable connection is made by, for example welding, soldering or gluing the common elements of the structure, the mating parts of the device.

[00016]
Furthermore, the snare, catheter and guide are made of metal, for example, nitinol, stainless steel, or radiopaque alloy; polymer materials, for example, polyamide, Capron, nylon; a composite material. Furthermore, the catheter is made: with double walls; with walls made movable relative to one another;
perforated. Furthermore, the guide is made: of at least two separate wires;
with a snare between the distal ends of the two wires; with wires that are movable relative to one another. The guide is placed: inside the catheter; outside the catheter;
between the catheter walls.

[00017]
This technical result is also achieved by the fact that, in the second embodiment, the device for manipulations with foreign objects in hollow organs consists of a catheter, guide and snare, wherein the snare, catheter and guide are made from one original part, and the guide is made hollow or solid, wherein the snare is made with a mesh surface in at least one of the parts of the snare.

[00018] The initial part may be, for example, a tube, wire, or band.
Furthermore, the initial part is made from: metal, for example, nitinol, stainless steel, or radiopaque alloy; polymer materials, for example, polyamide, Capron, nylon;
a composite material.

=
=
. .
= Atty. Docket No. 060738.0017

[00019]
In the proposed invention, a detachable connection is defined as a connection that at any point in time may be separated, in contrast to a nondetachable connection. The nondetachable connection may be made by welding, soldering .or gluing the common elements of the structure, the mating parts of the device, or by any other method known to the specialist, and the detachable connection may be made using a catch, thread, hook, or grip or any other method known to the specialist.

[00020]
The catheter is a tube made of metal, polymer or composite materials, for example, nitinol, stainless steel, radiopaque alloy, polyamide or their composites.

[00021] The hollow guide is a guide with a clear space inside, i.e., a channel of any form, and may be made of metal, polymer or composite materials, for example, nitinol, stainless steel, polyamide or nitinol-reinforced polyamide.
The solid guide does not have a clear space inside, wherein the solid guide may be metal, non-metal, composite, single-strand, or multi-strand.

[00022] The sum total of distinguishing features presumes different embodiments and competitive advantages of the proposed device to ensure a wide range of additional capabilities and thereby increasing the efficiency of manipulations at the operating site of the foreign object.

[00023]
For example, the connection of the snare simultaneously (at one time) with the catheter and guide or with two wires of the guide ensures: the capture of an object of almost any size, since the area of the snare grab is adjusted only by moving the guide related to the catheter or two wires of the guide relative to one another, and there is nothing to limit the extent of this movement; the reliable retention of the foreign object during extraction, regardless of its dimensions and shape is guaranteed by the mesh surface of the snare and the ability to place it distally = =
Atty. Docket No. 060738.0017 (behind) the object; guaranteed liberation of the foreign body from the snare is accomplished by simply moving the mesh surface of the snare from the "back"
position to the "side" position relative to the object.

[00024]
In the embodiment with hollow guide, after a foreign object is caught in the snare, the device makes it possible to additionally target the object, for example, a ureteral calculus, feed a lithotripter probe through the guide channel, perform contact fragmentation of the stone held inside the snare, collect and remove its fragments without damaging internal organs; to continuously drain the kidney and ureter, preventing complications from the impairment of urine drainage; to administer pain relievers, contrasting agent to determine the position of the stone, lubricants to facilitation the traction of the stone and its fragments; to use angiographic guides; to move the device toward the foreign body and visualize the position of the snare; and to use other instruments and substances at the surgical site of the foreign object. The catheter's perforation improves the drainage of a hollow organ.
BRIEF DESCRIPTION OF THE DRAWINGS

[00025]
The concept of the invention and certain embodiments of the device are explained by the drawings. The drawings are schematic to highlight the distinguishing features of the different embodiments of the device.

[00026]
Figure 1 depicts embodiments of the device with the nondetachable connection of mating parts through welding, soldering or gluing at the points of connection (4): a - snare (3) with catheter (1) and guide (2) made hollow; b -snare (3) with catheter (1) and guide (2) made solid; c - snare (3) drawn by guide (2) into catheter (1) and the device in transport mode for delivery to the foreign object.

[00027]
Figure 2 depicts the embodiment of the device: a ¨
nondetachable connection (4) of snare (3) with catheter (1) using design elements Atty. Docket No. 060738.0017 common to both, for example, common wires to reinforce catheter (1) and forming snare (3) and solid guide (2); b ¨ detachable connection of solid guide (2) with snare (3) for example, a grip or catch from within with element (5) on the distal end of the snare; snare (3) is twisted by guide (2) into transport mode for delivery to the object.
The guide is inside the catheter.

[00028] Figure 3 depicts the embodiment of the device where: a ¨
nondetachable connection (4) of snare (3) with catheter (1) using design elements common to both, for example, common wires to reinforce catheter (1) and forming snare (3) with element (5) for external stopping of guide (2) in it; b ¨
detachable connection of hollow guide (2) with snare (3) using, for example, the catch in element (5) on the distal end of the snare; snare (3) is folded inside guide (2) in transport mode for delivery to the object; the guide is outside the catheter.

[00029] Figure 4 depicts the embodiment of the device where: a -nondetachable connection (4) of snare (3) with two guides (2), located between the catheter's walls (1); b ¨ snare (3) is drawn by guide (2) between the catheter's walls (1) and the device is put in transport mode for delivery to the object; c -snare (3) is folded within the outer walls of catheter (1) in transport mode for delivery to the object; the guide is between the catheter's walls.

[00030] Figure 5 depicts: a - snare (3) formed from the distal end of catheter (1) and guide (2); b - snare (3) and guide (2), formed from the common wires of catheter (1).

[00031] Figure 6 diagrams the production of the device from one part ¨
the catheter: a ¨ the intermediate step in the production of the device where, from the initial part, a differently sized catheter, in which the diameter of left part (6) is greater than the diameter of right part (7), a segment is cut out in its middle part (8), from =
. = .
= =
Atty. Docket No. 060738.0017 which the snare will be formed. b ¨ the assembled device. Snare (3) has been formed from the middle part of the initial piece, and the right part of the initial piece (7) becomes hollow guide (2) and is inserted into the left part of the initial part (6), which becomes catheter (1) of the device. The mesh surface of snare (3) is shown in view A.

[00032] Figure 7 diagrams the production of the device from one single-strand wire: a - the intermediate step in the production of the device; a single-strand wire is wound onto a template to form left catheter (6), and then, through interval (8), from which snare (3) will be formed, a second catheter (7) with a diameter smaller than the diameter of catheter (6) is formed; b ¨ the assembled device; the sequence of actions to assemble the device and number the elements and parts of the initial part on the drawing are the same as those shown in figure 6b.

[00033]
Figure 8 diagrams the production of the device from one multi-strand wire; the procedure for producing the device and numbering its elements and parts is the same as in figure 7; mesh surface 15 of snare (3) is depicted in view A.

[00034] Figure 9 diagrams the production of the device from one multi-strand wire; the procedure for producing the device and numbering its elements and parts is the same as in figures 7 and 8, the mesh surface of snare (3) is depicted in view A.

[00035]
Figure 10 diagrams a variant of the device's operation showing:
hollow organ (ureter) (9) and foreign objects: ureteral calculus (10), probe (11) and stone fragments (12).

[00036]
Figure 11 diagrams a variant of the device's operation showing:
catheter (1), snare (3) and probe (13).
DETAILED DESCRIPTION OF THE INVENTION

= .
= =
Atty. Docket No. 060738.0017

[00037]
The device for manipulations with foreign objects in hollow organs in the first embodiment consists of catheter 1, guide 2 and snare 3 with mesh surface. The snare may be connected with the catheter and/or guide permanently at connection point 4 (1 a-c) and/or detachably at connection points 5 (fig. 2a, b; 3a, b), while the guide is made hollow (fig. la) or solid (fig. lb), wherein a mesh surface is made on at least one of the parts of snare 3 (fig. la, b; 2a; 3a; 5a, b, 6b;
8b; 9b).

[00038]
The device for manipulations with foreign objects in hollow organs in the second embodiment consists of catheter 1, guide 2 and snare 3 with mesh surface. Snare 3, catheter 1, and guide 2 are made from one initial part, for example, a tube with different diameters in parts 6 and 7 (fig. 6a), and single-strand (fig. 7) or multi-strand (fig. 8, 9) wires, wherein the mesh surfaces is made in at least one of the parts of the snare (fig. 8b, 9b).

[00039] An attribute of the embodiment of the device depicted in fig. 1 is the ability to place the mesh surface in different parts of the loop-shaped snare (3) by retracting guide (2) into catheter (1) or protracting guide (2) from catheter (1). An attribute of the embodiment of the device depicted in fig. 2 is that, after the object is captured by open snare (3) (fig. 2a) it is possible to remove guide (2) from catheter (1) and thereby fully free the clear space of catheter (1) for the operation of another instrument.

[00040] An attribute of the embodiment of the device depicted in fig.
3a, is that, after the object is in snare (3), it is possible for it to be rigidly fixed in three dimensions in snare (3) by advancing guide (2) onto snare (3) with the object.

[00041] An attribute of the embodiment of the device depicted in fig. 4 is the ability to independently change the size of the snare and the location of the =
. .
= Atty. Docket No. 060738.0017 =
mesh surface on it (snare) by changing the longitudinal arrangement of the two wires of guide (2) relative to one another.

[00042] An attribute of the embodiment of the device depicted in fig. 5 is the demonstration of the ability to produce snare (3) and catheter (1) (fig. 5a) and snare (3) and solid guide (2) (fig. 5b), respectively from one catheter and the same wires.

[00043] An attribute of the embodiment of the device depicted in fig. 6 is the simplicity of its production from one part (tube) and the "absolute"
reliability of the connection of all parts of the device ¨ snare (3), catheter (1), and guide (2), which constitute a single whole.

[00044] An attribute of the embodiment of the device depicted in fig. 7 is the production of the device from one elementary part ¨ a single-strand wire ¨ and the "absolute" reliability of the connection of all its parts ¨ snare (3), catheter (1), and guide (2), which constitute a single whole.

[00045] An attribute of the embodiment of the device depicted in fig. 8 is that multi-strand middle part (8) (fig. 8a) may be used to form snare (3) with a mesh surface, which is depicted in view A (fig. 8b).

[00046] A
feature of the device depicted in fig. 9, is that it shows how not a hollow, but a solid, guide (2) is formed.

[00047] The device operates as follows. The device with closed snare (3) is introduced through the instrument channel of an endoscope into ureter (9) (fig.
10a) and manipulations with a foreign object, for example, ureteral calculus (10) are performed. Contrasting agent is administered through the clear space of the hollow guide to determine the position of the stone if necessary. Protracting the guide from catheter (1) moves snare (3) to the open working position (fig. 10a) and lowers the . = .
= Atty. Docket No. 060738.0017 snare (3) until the stone is capture in the snare loop. Then, drawing guide (2) into catheter (1) places the mesh surface of the snare distally (behind) relative to the stone (fig. 10b). The stone captured in the snare and the device are removed. If the large size or complex shape of the stone makes it impossible to remove it by one-time traction, then a lithotripter probe (11) is introduced into the clear space of the hollow guide until it stops at stone (10) (fig. 10b) and contact basket lithotripsy is performed until fragments of the stone are formed (fig. 10c). Stone fragments (12) gathered into snare (3) are removed. Objects not as hard as ureteral calculi may be disintegrated by mechanical fragmentation by the wires of the snare (gall stones) or vacuum suction (thrombi, blood clots).

[00048]
The proposed device may be used to remove not only foreign objects of "natural" origin such as stones, thrombi, polyps, tumors, etc., but also "human factor" objects such as coins, marbles, nuts, fragments of catheters, wires, etc.

[00049]
The proposed device may be used to install and, if necessary, subsequently remove artificial foreign objects, for example, stents in tubular organs (not shown on the drawings), and also to move a foreign object, for example, a probe (13) from one part of a hollow organ to another (fig. 11 a, b).

[00050]
The ability to use detachable and nondetachable connections between the snare and catheter and/or guide, hollow and solid, single- and multi-strand guides, and different types of snares enables the operator to select the optimum embodiment of the device depending on the specific surgical environment.

[00051]
These examples do no limit the industrial design, materials or process for producing the parts and entire device. When the proposed invention is implemented in practice within the scope of the sum total of the claimed attributes and when specific embodiments of the device are produced, all materials and methods of , Atty. Docket No. 060738.0017 production of catheters, snares, guides and their connections known to specialists may be used. The claimed device in both embodiments may be widely used to extract foreign bodies from hollow and tubular organs, for example, kidney and gall stones, thrombi, and polyps, and for other manipulations with foreign object.

Claims

1. A device for manipulations with foreign bodies in hollow organs, comprising;
a catheter, a hollow guide and a snare with a mesh surface connected to the guide, and the snare is additionally connected to the catheter and is made so that the mesh surface is placed in different parts of the snare

2. The device in claim 1, wherein the guide is solid.

3. The device in claim 1, wherein the snare is connected with the catheter and guide through a detachable or nondetachable connection, the detachable connection being made with the help of, for example, a thread, hook, or grip, and the nondetachable connection being made, for example, by welding, soldering or gluing the common elements of the structure, the mating parts of the device.

4. The device in claim 1, wherein the snare, catheter, and guide are made of metal, for example nitinol, stainless steel, or radiopaque alloy.

5. The device in claim 1, wherein the snare, catheter and guide are made of polymer material, for example polyamide, Capron or nylon.

6. The device in claim 1, wherein the snare, catheter and guide are made of composite material.

7. The device in claim 1, wherein the catheter has double walls.

8. The device in claim 7, wherein the catheter walls are made to be mobile relative to one another.

9. The device in claim 1, wherein the guide contains at least two wires, between the distal ends of which the snare is situated.

10. The device in claim 1, wherein the wires are made to be mobile relative to one another.

11. The device in claim 1, wherein the guide is placed inside the catheter.

12. The device in claim 1, wherein the guide is placed outside the catheter.

13. The device in claim 1, wherein the guide is placed between the catheter's walls.

14. The device in claim 1, wherein the catheter is perforated.

15. A device for manipulating foreign bodies in hollow organs including;
a catheter, a guide and a snare, wherein the snare, the catheter and the guide are made from one initial part, while the guide is hollow or solid, and the snare has a mesh surface in at least one of the parts of the snare.

16. The device in claim 15, wherein the initial part is at least one of a tube, a wire, and a band.

17. The device in claim 15, wherein the initial part is made of at least one of a metal, a nitinol, a stainless steel, and a radiopaque alloy.

18. The device in claim 15, wherein the initial part is made of polymer material, a polyamide, Capron or nylon.