WO2012110619A1 - Dispositif médical pour l'élimination de calculs, et système doté d'un tel dispositif médical - Google Patents

Dispositif médical pour l'élimination de calculs, et système doté d'un tel dispositif médical Download PDF

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Publication number
WO2012110619A1
WO2012110619A1 PCT/EP2012/052724 EP2012052724W WO2012110619A1 WO 2012110619 A1 WO2012110619 A1 WO 2012110619A1 EP 2012052724 W EP2012052724 W EP 2012052724W WO 2012110619 A1 WO2012110619 A1 WO 2012110619A1
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WO
WIPO (PCT)
Prior art keywords
individual segments
actuating means
thrombus
individual
axial
Prior art date
Application number
PCT/EP2012/052724
Other languages
German (de)
English (en)
Other versions
WO2012110619A9 (fr
Inventor
Kirsi SCHÜSSLER
Giorgio Cattaneo
Frank Nagl
Original Assignee
Acandis Gmbh & Co Kg
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Application filed by Acandis Gmbh & Co Kg filed Critical Acandis Gmbh & Co Kg
Publication of WO2012110619A1 publication Critical patent/WO2012110619A1/fr
Publication of WO2012110619A9 publication Critical patent/WO2012110619A9/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22034—Gripping instruments, e.g. forceps, for removing or smashing calculi for gripping the obstruction or the tissue part from inside
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A61B2017/32096—Incision instruments for slowly cutting through tissue, e.g. stent like temporary implants having sharp edges

Definitions

  • the invention relates to a medical device for removing concretions from hollow organs of the body and to a system with such a device.
  • a medical device with the features of the preamble of claim 1 is known for example from WO 2006/031410 A2.
  • thrombectomy system used so-called thrombectomy system. Here are on
  • the system known from the aforementioned WO 2006/031410 A2 is a mechanically acting device for the removal of thrombi or blood clots, which comprises a catheter which is used to supply a basket-like
  • the basket-like catching element comprises a compressible and expandable grid structure.
  • the catch element In the expanded state, the catch element is arranged distally of the catheter and has a rotationally symmetrical structure.
  • the capture element is guided through the catheter to the treatment site and released.
  • the expansion forms the basket-like structure of the catchment.
  • a catheter is further connected to a suction unit, so that a negative pressure in the region of the basket-like Fangelements can be generated, which pulls the thrombus in the catch element.
  • the lattice structure of the catching element rests against the vessel wall of the blood vessel to be treated.
  • the thrombus is encapsulated in the catching element and can then be drawn into the catheter together with the catching element.
  • the invention is therefore based on the object to provide a medical device for removing concretions from hollow organs of the body, the safety of use is improved with ease of use. It is another object of the invention to provide a system having such a medical device.
  • the invention is based on the idea of a medical device for
  • the catch elements are connected to an actuating means such that they are relatively movable with respect to a supply line of a supply system.
  • Catching elements form at least two member-like individual segments, which are arranged below the actuating means below and in each case separately with the
  • Actuating means are connected, wherein the individual segments are independently compressible and expandable.
  • the invention is based on a different concept than the thrombectomy system known from WO 2006/031410 A2, in which an aspiration device is absolutely necessary in order to suck the thrombus into the collecting basket resting against the vessel wall.
  • the catcher must be placed proximally from the thrombus.
  • the invention is adapted and provided for releasing the catch elements in the thrombus or at the level of the thrombus, ie, these
  • the catching elements abut against the inside of the thrombus if it does not completely block the blood vessel or the hollow body of the body, but is formed only on the vessel wall, or if the catching elements do not penetrate the thrombus during expansion, but laterally on the Press vessel wall. If at least one penetration of the thrombus by the capture elements takes place, a particularly secure adhesion between the thrombus and the device takes place, whereby the safety of use in the removal of the thrombus is improved.
  • the invention works but also if the Thrombus is only partially penetrated.
  • the thrombus can be supported by biomechanical mechanisms to grow the structure of the capture elements, thereby improving attachment. It is also possible that the thrombus and the catch elements do not penetrate or attachment in the sense of endothelialization takes place. In this case, the thrombus is arrested by the friction of the catching elements.
  • the compressible and expandable capture elements are adapted to hold the calculus or thrombus from the inside, so that the thrombus is located between the capture elements and the vessel wall during removal.
  • a direct contact of the catch elements with the vessel wall is characterized
  • the catch elements or, as a whole, the device according to the invention are adapted not to be arranged exclusively proximal to the concrement.
  • the aspiration device is not absolutely necessary for the removal of the thrombus or concretion, but may additionally be provided in order to prevent parts of the thrombus which detach upon removal from entering the bloodstream but being sucked off by the aspiration device. The removal of the thrombus occurs in the
  • the anchored catch elements are also used to hold the dissolved calculus in the supply line when it is retracted.
  • the invention comprises compressible and expandable catch elements, which are anchored in the calculus, wherein the catch elements are connected to the actuating means such that they are relatively movable with respect to the supply line.
  • the medical device is disclosed and claimed in connection with the system comprising the medical device for removing concrements and a supply device with a supply line in which the
  • the Device is arranged, wherein the catching elements are movable by the actuating means relative to the supply line.
  • the catch elements can be at least partially, in particular completely discharged from the supply line and retracted together with the actuating means.
  • the inventive device further provides that the catch elements form at least two member-like individual segments, which are arranged below the actuating means below and each separately connected to the actuating means.
  • the individual segments are independently compressible and expandable. Due to the limb-like individual segments causes an axial elongation due to the retention force through the thrombus, which leads to a radial compression of the catch elements and thus to a reduction of the holding force, as far as possible avoided or at least greatly reduced.
  • FIG. 1 show a thrombectomy system which is formed without the individual segments according to the invention, but has a continuous lattice structure which is anchored to the calculus.
  • a rotationally symmetric expansion body whose wall is made of a lattice structure, brought into the region of the thrombus to be removed and expanded there, so that the lattice structure penetrates into the thrombus.
  • a part of the lattice structure is arranged distally (in FIG. 1 a to the left of the thrombus) and lies there directly against the vessel wall.
  • a force acting in the proximal direction is applied through the wire connected to the proximal end of the lattice structure. Due to the retention force of the thrombus, as in the lower part of fig. 1, the lattice structure extended in the axial direction. This results in a radial compression of the lattice structure, as also well visible in Fig. 1, whereby a decoupling, at least a partial decoupling of the lattice structure of the thrombus takes place. Thus, the dissolving force is concentrated on a smaller area of the thrombus, optionally, as shown in Fig. 1, also on the part of the
  • member-like individual segments prevents the radial compression along the entire device continues.
  • the radial compression is reduced.
  • the axial length of the individual NEN segments can be selectively controlled how much the radial compression is reduced. The shorter the individual segments, the lower the radial compression.
  • the applied by the actuating means axial tensile force is transmitted to the more distally arranged individual segments by the actuating means and not by the proximally arranged individual segments. This means that the axial extension of a distally arranged single segment does not lead to a stretching and thus not to a radial compression of the more proximal
  • the arranged individual segments leads.
  • the individual segments are thus substantially decoupled from each other, so that the transmission of the axial tensile forces is done separately only by the actuating means on each grid-like single segment.
  • the invention provides that the limb-like individual segments, which are formed from the catching elements, are arranged below the actuating means below.
  • the required total length of the device is adjusted to keep the concretion as complete as possible.
  • the length of the device is determined by the person skilled in the art by the length of the respective individual segments and / or the spacing of the individual segments
  • the individual segments are each separately connected to the actuating means, so that the above-described mode of action, namely the separate power transmission from
  • Actuating means is achieved on the individual segments.
  • the individual segments are independently compressible and expandable, so that a
  • a scale effect is achieved by the limb-like individual segments, by which the individual segments on the one hand adhere to the required length of the calculus to be removed and on the other hand, the individual segments in the axial direction or along the actuating means are decoupled from each other, so that a release force only on the actuating means and is not transferred to these via the individual segments.
  • the individual segments each have a proximal end and a distal end, the proximal end being connected to the actuating means and the distal end being radially movable for compressing and expanding the single segment.
  • the distance formed between the proximal and distal ends of the length of the single segment is determined, ie the length between the fixed to the actuating means and the freely movable end of the single segment.
  • the individual segments each have an axially tapering in the proximal direction axial portion, in particular first axial portion which is connected to the actuating means.
  • proximal means closer to the user.
  • distal means further away from the user. This definition applies to the entire application.
  • the individual segments each have at least one axial section, in particular second axial section, which is of cylindrical design at least in the expanded state and can be anchored to the calculus. Due to the cylindrical shape, an atraumatic configuration of the portion of the respective individual segments is achieved, which transfers the release force from the actuating means to the calculus. Moreover, the individual segments each have at least one axial section, in particular second axial section, which is of cylindrical design at least in the expanded state and can be anchored to the calculus. Due to the cylindrical shape, an atraumatic configuration of the portion of the respective individual segments is achieved, which transfers the release force from the actuating means to the calculus. Moreover, the
  • the total length of the single segment is relatively short.
  • the total length of the single segment is determined mainly by the length Li of the tapered first axial section.
  • the length Li runs on the
  • the different individual segments can be assigned different functions.
  • the different individual segments can be assigned different functions. For example, the
  • the maximum outer diameter of the individual segments decrease in the proximal direction.
  • the individual segments with a relatively large outer diameter are arranged distally and the individual segments with a relatively smaller outer diameter are arranged proximally.
  • the increased distal outer diameter achieves a protective function which prevents or reduces the risk that individual parts or even the entire concretion will be lost when the device is re-drawn into the catheter or when the object is recovered.
  • the distally arranged individual segments with the relatively larger outer diameters essentially act as filters. If at least three individual segments are provided, the proximal and distal outer segments may have a larger or smaller maximum outer diameter than the arranged between the outer individual segments inner single segment or as arranged between the outer individual segments inner individual segments.
  • the calculus can be clamped between the outer individual segments. If the individual segments are arranged with the larger maximum outer diameters inside, ie between the outer individual segments, a particularly large anchoring force can be set in the area of the calculus to be removed, while at the same time preserving the individual segments at the axial ends of the thrombus.
  • the individual segments each have a compressible and expandable, in particular self-expandable grid structure.
  • the self-expandable lattice structure has the advantage that the handling of the individual segments is simplified because they are released for deployment without further aids from the supply system and expand automatically.
  • the various individual segments may have different lattice structures. This also makes it possible to assign different functions to the different individual segments.
  • a simple production of the individual segments for example by laser cutting, can be achieved if at least a part of, in particular all individual segments, cells which are formed leaf-like at least in the expanded state and each have a longitudinal axis L z , wherein the longitudinal axis L z at least egg ner cell and the longitudinal axis L B of the currently arranged actuating means in the same plane.
  • a basket-like structure is provided, which has a relatively short length and is expandable or compressible.
  • x-ray markers are respectively arranged at the distal ends of the individual segments.
  • radiopaque regions are created along the device. Their expansion allows the user to evaluate the area of the thrombus, in particular an incomplete one
  • the individual segments may be arranged in the compressed state overlapping or non-overlapping.
  • the overlapping arrangement of the individual segments can be achieved by the axial elongation of the system, for example when compressing to the feed diameter. In this way, it is possible that the distance between two individual segments in the expanded state is minimized or even brought to zero.
  • the overlap is set to be in the compressed and expanded states. It is possible to overlap some individual segments and arrange some individual segments non-overlapping. If the individual segments in the compressed state, in particular in the catheter in the non-overlapped state are arranged one behind the other, these are spaced apart during expansion by the concomitant axial shortening. It is possible that individual identical or differently formed individual segments each have different distances to the correspondingly arranged in front of or behind these individual segments.
  • the length of the overall device on the one hand and the feed diameter on the other can be influenced.
  • FIG. 2 is a plan view of the individual segments of a device according to an embodiment of the invention.
  • FIG. 3 shows the device according to FIG. 2 in the blood vessel
  • FIG. 4 shows the device according to FIG. 2 with bent actuating means
  • FIG. 5 shows a further embodiment of the invention with individual segments whose outer diameter increases in the proximal direction
  • FIG. 6 shows a further embodiment of the invention with individual segments, the outer diameter of which decreases in the proximal direction;
  • Fig. 7 shows another embodiment with individual segments whose
  • FIG. 8a shows a further embodiment in which the proximal and distal outer individual segments have a larger outer diameter than the individual segments arranged therebetween;
  • FIG. 8b the device of FIG. 8a in the blood vessel anchored
  • FIG. 10 shows a device according to an embodiment of the invention with a modified grid structure in which cutting teeth and holding teeth are provided;
  • Fig. 11 shows a device according to another invention
  • FIG. 12 shows a device according to an embodiment of the invention with a modified lattice structure, in which the individual segments
  • Fig. 13 shows a device according to an embodiment of the invention, which represents a variant of the example according to FIG. 5;
  • Fig. 14 shows a further embodiment of the invention, which is a variant of
  • Embodiment of FIG. 6 represents
  • Fig. 15 shows a further embodiment of the invention, which is a variant of
  • Embodiment of FIG. 8a represents
  • Fig. 16 shows a further embodiment of the invention, which is a variant of
  • Embodiment of FIG. 2 represents
  • Fig. 17 anchored the device of FIG. 15 in the blood vessel
  • FIG. 18 shows a plan view of the insertion segments of a device according to a further embodiment of the invention.
  • FIG. 19 is a front view of a single segment of the device of FIG.
  • FIG. 20 is a plan view of the single segment of FIG. 19; FIG.
  • Fig. 21 is a plan view of a variant of the device according to FIG. 18 with modified connecting means.
  • FIG. 22 shows a front view of a single segment of the device according to FIG.
  • Fig. 2 shows schematically a plan view of a medical device for removing concretions from hollow organs of the body, which is used in practice in a thrombectomy system.
  • the device according to FIG. 2 is arranged in the supply line of a catheter and axially in the proximal and in the distal direction Sliding direction. The axial displaceability of the device in the
  • Supply line (not shown) serves on the one hand to transport the device in the region of the catheter tip.
  • the axial mobility serves to release the device placed in the region of the catheter tip from the supply line and, if necessary, to collect it again.
  • the medical device is therefore both intrinsically, i. disclosed and claimed without the supply line as well as in connection with the Thrombektomiesystem. In the latter case, the device is part of the system (thrombectomy system with a medical device for removing concrements) and axially displaceable in a supply line of the system.
  • the device according to FIG. 2 has compressible and expandable elements 10.
  • the catch elements 10 extend radially outward and form in the
  • the catch elements 10 are each connected to an actuating means 11, which may be for example a feed wire.
  • actuating means for example tubular components are possible.
  • the actuating means are flexible to allow the device to adapt to vessel bends.
  • the actuating means 11 is adapted to transmit forces in the proximal direction and in the distal direction, in particular the forces required to release and recover the calculus.
  • the catch elements 10 each form limb-like individual segments 12a, 12b, 12c, 12d.
  • the limb-like individual segments 12a, 12b, 12c, 12d are arranged along the actuating means 11.
  • the individual segments 12a, 12b, 12c, 12d are arranged below, ie lined up one behind the other.
  • the individual segments 12a, 12b, 12c, 12d are each spaced from each other. It is also possible that the individual segments are aligned directly, ie without spacing behind each other.
  • the longitudinal axis of the actuating means 11 at the same time forms the central axis of the member-like individual segments 12a, 12b, 12c, 12d.
  • the individual segments 12a, 12b, 12c, 12d are even Actuating means 11 arranged coaxially.
  • the individual segments 12a, 12b, 12c, 12d are rotationally symmetrical.
  • the individual segments 12a, 12b, 12c, 12d are each connected separately to the actuating means 11 and are independently compressible and expandable. Due to the separate connection of the individual segments 12a, 12b, 12c, 12d with the actuating means 11, the axial force transmitted by the actuating means 11 is introduced individually into each individual individual segment 12a, 12b, 12c, 12d. In addition, the individual segments 12a, 12b, 12c, 12d are independently compressible and expandable, so that the individual segments 12a, 12b, 12c, 12d are mechanically decoupled from each other.
  • the mechanical decoupling causes the forces transmitted by the actuating means 11 is not transmitted from a single segment 12a to the next single segment 12b, etc., but due to the separate attachment of the individual segments 12a, 12b, 12c, 12d with the actuating means 11 only by the actuating means 11th
  • the mechanical decoupling is achieved concretely in that the distal ends 13b of the individual segments 12a, 12b, 12c, 12d are not connected to the respective following individual segment 12a, 12b, 12c, 12d.
  • the distal ends 13b of the individual segments 12a, 12b, 12c, 12d are free.
  • connection of the respective individual segments 12a, 12b, 12c, 12d with the actuating means 11 takes place at the proximal end 13a of the respective individual segment 12a, 12b, 12c, 12d, in particular only at the proximal end 13a of the respective single segment 12a, 12b, 12c, 12d.
  • the free distal ends 13b are radially movable to compress and expand the respective single segment 12a, 12b, 12c, 12d.
  • the radial movement takes place by discharging the respective individual segment 12a, 12b, 12c, 12d from the supply line (not
  • each individual segment 12a, 12b, 12c, 12d has a first axial section 14a, which tapers in the proximal direction.
  • the smallest diameter of the first axial section 14a is located.
  • the single segment 12a, 12b, 12c, 12d is connected to the actuating means 11.
  • the first axial section 14a changes in the distal direction into a second axial section 14b, which is of cylindrical design.
  • the second axial section 14b ends in the region of the distal end 13b of the respective individual segment 12a, 12b, 12c, 12d and forms an atraumatic contact surface of the concretion.
  • the embodiment according to FIG. 2 specifically has a basket-like or basket-shaped grid structure 15.
  • the first axial section 14a which tapers in the proximal direction and at which the individual segments 12a, 12b, 12c, 12d are respectively connected to the actuating means 11, has a conical shape.
  • the conical region merges into the cylindrical region of the second axial section 14b.
  • the cells of the lattice structure of the respective individual segment 12a, 12b, 12c, 12d are sheet-like and extend outwardly at an increasing opening angle.
  • the cells 16 are each formed from at least four webs 23, which have an approximately diamond-shaped basic shape in the plan view or projection.
  • the distal tip 24 of the respective cell 16 is rounded and acts thereby
  • the opening of the basket-like structure faces in the distal direction.
  • the second axial section 14b or the distal end 13b of the respective individual segment 12a, 12b, 12c, 12d can protrude radially inwards, whereby the risk of injury is further reduced.
  • the distal end 13b may also project radially outward. This allows a better grip of the thrombus.
  • the distal ends 13b may project vertically outwardly or inwardly and / or may be inclined in the distal and / or proximal directions.
  • the distal end 13b may also be located on the cylindrical lateral surface.
  • the individual member-like individual segments 12a, 12b, 12c, 12d are adapted in such a way that they can be retracted into a delivery catheter. Therefore, for example, the open bridge tips are usually directed in the feed direction, ie they point in the distal direction, so that they do not tilt with the inlet opening of the supply line. In addition, this leads to an improved atraumatic behavior of the device with respect to the vessel wall. It is also conceivable, as described above, that the distal ends 13b protrude perpendicularly outwardly and / or are inclined in the proximal direction, so that they act like a barb.
  • the ends should be anchored in the thrombus so that they are embedded in the material of the thrombus and thus not with the edge of the thrombus Feed line collide. It is also possible to provide for single segments with different diameters only the individual segments with dress ner diameter with barb-shaped ends 13 b, which can be easily retracted, since the diameter of the supply line is greater than that
  • the connecting means 22 may be formed as a third axial section 14c of the respective individual segment 12a, 12b, 12c, 12d.
  • the third axial section 14 c is cylindrical and has an outer diameter that approximately corresponds to the minimum outer diameter of the first axial section 14 a.
  • the first axial section 14a merges into the third axial section 14c.
  • the inner diameter of the third axial section 14 c is dimensioned such that the
  • Actuator 11 passes through and can be connected to this or is connected.
  • the third axial section 14c is either a separate component, for example a sleeve, which is connected to the first axial section 14a, for example by material bonding by welding.
  • the first axial section 14a for example by material bonding by welding.
  • Axial portion 14a and the third axial portion 14c to be integrally formed. This can be achieved by the third axial section 14c or the
  • Connecting means 22 and the catch elements 10 are made of the same pipe material in one piece, for example by laser cutting.
  • a tube is structured such that individual sections are expanded more, which then form the catch elements 10, as other sections, which then form the connecting elements 22. Concretely, it is possible not to expand the connecting elements 22 and / or not to structure, so that the original pipe diameter is maintained.
  • connection of the connecting means 22 and the third axial portion 14c are particularly suitable crimping or welding.
  • the thrombus is acted on by the radial force of the catch elements 10 arranged in the region of the thrombus.
  • To remove the thrombus is pulled on the actuating means 11 until the thrombus dissolves from the vessel wall. Due to the radial force of
  • Capture elements 10 of the thrombus adhere to these and can be retracted into the catheter or the catheter line.
  • the individual segments 12a, 12b, 12c, 12d are successively compressed by the tapered first portion 14a until they reach the feed diameter or crimp diameter and fit into the feed line.
  • the stuck between the individual segments 12a, 12b, 12c, 12d thrombus is taken along and also introduced into the supply line. Then the thrombus can be retrieved from the body together with the catching elements 10 now located in the supply line.
  • link-like individual segments 12a, 12b, 12c, 12d The advantage of the link-like individual segments 12a, 12b, 12c, 12d is that the pulling force does not set any elongation of the individual segments or at least no significant elongation and no associated radial compression, so that the of the individual segments 12a, 12b, 12c, 12d on the thrombus
  • a further advantage of the device according to FIG. 2 is that the individual segments 12a, 12b, 12c, 12d are connected to one another in an articulated manner by the actuating means 11, so that the individual segments 12a, 12b, 12c, 12d are connected to vessel segments. Adjust curvature without being flexible or flexible in itself. This is shown in FIG. 4 to recognize.
  • the flexibility that can be achieved on account of the articulated arrangement of the individual segments 12a, 12b, 12c, 12d is promoted by a construction having a relatively large number of individual segments 12a, 12b, 12c, 12d.
  • at least 2, in particular at least 3, at least 4, at least 5, at least 6 individual segments are provided.
  • the upper limit can be, for example, a maximum of 20 individual segments. The upper limit may vary according to different purposes.
  • relatively short individual segments 12a, 12b, 12c, 12d are advantageous, for example, a maximum length of 1.5, in particular of at most 1, in particular at most 0.8, in particular at most 0.6, in particular at most 0.4 cm per single segment 12a , 12b, 12c, 12d.
  • FIGS. 5 to 8 b show various exemplary embodiments in which the individual segments 12 a, 12 b, 12 c, 12 d have different maximum outer diameters. This applies to the expanded state.
  • the maximum outer diameter of a single segment is determined by that portion of the single segment which protrudes furthest in the radial direction or the largest distance to the
  • the maximum outer diameter of a single segment 12a, 12b, 12c, 12d corresponds to the outer diameter of the cylindrical second axial section or generally the distal outer section of a single segment which bounds the distal-facing opening of the single segment in the radial direction.
  • the radial outer diameter of a single segment corresponds approximately to the maximum opening diameter plus the wall thickness of the single segment.
  • Embodiment of FIG. 5 takes the maximum outer diameter of
  • the device according to FIG. 5 has the advantage that by the reduction of the outer diameter in the distal direction (or the increase of the outer diameter in the proximal direction), an improved adaptation of the device to the usually decreasing
  • Diameter of distal vessels is adjusted. This will increase the effectiveness of
  • the change in the maximum outside diameter is reversed as in the embodiment according to FIG. 5.
  • the maximum outside diameter decreases in the proximal direction or increases in the distal direction.
  • the ratio between the maximum outer diameter of the smallest single segment and the largest single segment is at most 0.8, in particular at most 0.6, in particular at most 0.4. This applies to both embodiments according to FIG. 5 and 6 and for all other embodiments in which
  • FIGS. 7 to 8b Further exemplary embodiments, in which the individual segments 12a, 12b, 12c, 12d have different maximum outer diameters, are shown in FIGS. 7 to 8b shown. In both embodiments, several individual segments
  • At least two, in particular at least 3, in particular at least 4, in particular at least 5, in particular at least 6 individual segments with the smaller maximum outer diameter are arranged directly one behind the other.
  • the individual segments with the smaller maximum outer diameter are intended to expand in the area of the thrombus.
  • maximum outside diameter limits the radial force acting on the thrombus, which enables a particularly vessel-friendly detachment of the calculus. In both embodiments according to FIGS. 7 and 8a, it is distal to the individual segments with the smaller maximum outside diameter
  • This combination of the individual segments having the smaller maximum outside diameters and the larger maximum outside diameters means that in addition to the adhesion due to the radial force of the individual segments having the smaller maximum outside diameters, an axial force can act on the concretion from the distally disposed single segments having the larger maximum outside diameter is exercised when pulling on the actuating means 11.
  • a first group of individual segments 12c, 12d with a small maximum outside diameter and a second group of individual segments 12a, 12b with a larger maximum outside diameter are provided, wherein the second group is arranged distally of the first group. Proximally from the first group no catch elements are provided.
  • FIG. 8a differs from the embodiment of FIG. 7b characterized in that the first group of the individual segments 12b, 12c is arranged with the smaller maximum outer diameter between two individual segments 12a, 12d with a larger maximum outer diameter. Instead of the two outer individual segments 12a, 12d, the distal and proximal of the inner or
  • middle individual segments 12b, 12c are arranged with the smaller maximum outer diameter, analogous to the embodiment of FIG. 7 groups of Single segments with greater maximum outer diameter may be provided, which are arranged both proximally and distally of the first middle group.
  • FIG. 8b the device of FIG. 8a is shown in use, wherein the catch elements 10 of the respective individual segments 12a, 12b, 12c, 12d with a
  • Fig. 8b can be further seen that a portion of the concretion in the region of the distal outer segment 12a penetrates through the lattice cells 16 of the lattice structure and is held in the region of the tip 14 of jewei time cell. This results in the desired axial anchoring of the calculus.
  • the tip 14 is located approximately at the level of the transition from the conical first portion 14a to the cylindrical second axial portion.
  • the web pairs 23, which are brought together in the area of the tip 24, are inclined relative to a plane running through the central axis or the actuating means 11 which is arranged straight, and form the conical shape of the first axial section tapering in the proximal direction.
  • FIGS. 5 to 8b are based on individual segments 12a, 12b, 12c, 12d, which have a sheet-like lattice structure, wherein each individual segment consists of a single row of cells 16, which on the circumference of the respective single segment 12a, 12b, 12c , 12d are arranged.
  • This basic structure applies to all individual segments 12a, 12b, 12c, 12d of the aforementioned embodiments.
  • the elements in the conical area can therefore be single cells (like leaves). This means that no further cell is arranged downstream in the radial and axial direction. These single cells may have a curved shape. A single cell forms both the conical and the cylindrical portion of the segment.
  • the individual segments 12a, 12b, 12c, 12d may have a lattice structure of a plurality of cell rows.
  • several cells may be arranged downstream in the radial and axial directions. It may be that only in the conical region two or more cells are arranged downstream.
  • the limb-like structure of the overall device is maintained, as for example, from the embodiment of FIG. 9 and from the embodiments of FIG. 10 to 12 can be seen.
  • the middle individual segment 12b is formed with closed cutting cells 18 which surround open holding cells 19 with flexible tongues 20.
  • the flexible tongues 20 are deflected during expansion by the contact with the concretion radially inwardly.
  • the structure of the middle single segment 12b is in the applicant
  • the basic structure of the middle single segment 12b according to FIG. 9 follows in connection with the individual segments according to FIGS. 1 to 8 explained basic construction and has a conical or in the proximal direction tapering first axial portion 14a and a subsequent to the first axial portion second cylindrical axial portion 14b.
  • the cylindrical second axial portion is formed longer, so that a total of a larger contact area between the
  • the central single segment 12b is therefore predominantly cylindrical and can be represented or realized as a stent-like structure with a conical end section (first axial section 14a).
  • the ratio of the length of the conical first axial section 14a to the total length (length of the first and second axial section) is at most 0.5, in particular at most 0.4, in particular at most 0.3, in particular at most 0.2, in particular at most 0, 1.
  • the conical first axial section has arm-shaped extensions, which are continued from the stent-like structure and bent inwards. The extensions 25 are connected to the actuating means 11.
  • the cylindrical area of a catchment is limited in length.
  • the cylindrical region may have at most 3 cells, in particular at most 2 cells, in particular 1 cell.
  • the cylindrical area is preferably at most 1.3 cm, in particular at most 0.8 cm, in particular at most 0.6 cm, in particular at most 0.3 cm long.
  • Lower limit can be set to a length of 0.1 cm.
  • the total length of a single segment 12a, 12b, 12c, 12d may be at most 1.5 cm, in particular at most 1.0 cm, in particular at most 0.8 cm, in particular at most 0.5 cm.
  • the lower limit can be set to a length of 0.3 cm.
  • the X-ray markers 26 provided at the distal ends 13b facilitate the location of the device.
  • the individual segments 12a, 12b, 12c, 12d can be connected to the actuating means 11 by welding, riveting, gluing, soldering, crimping, etc.
  • the proximal ends of the respective individual segments can be connected directly to the actuating means 11.
  • connecting elements such as sleeves, may be provided.
  • Single cells 16, from which the catch elements 10 are constructed are the same, in particular identical, for each individual segment 12a, 12b, 12c, 12d.
  • the length L of the respective cells 16 projected onto the actuation means 11 arranged in the straight state is the same (see, for example, FIG.
  • Single cells 16 are located in a plane, in particular in the same plane which intersects the actuating means 11 orthogonally in the straight state of the actuating means 11.
  • the shape of the cells 16 is the same. Specifically, the individual cells 16 jewei ls on a diamond-shaped basic shape. In the exemplary embodiments provided according to FIG. 13-16 four individual cells 16 are provided per single segment 12a, 12b, 12c, 12d, which form the basket-like catch elements 10 like a leaf. The individual cells 16 are on the circumference of each individual element 12a, 12b, 12c, 12d to the actuating means 11 arranged around. Otherwise, those shown in FIGS. 13-16 and in Figs. 5-8a and 2 illustrated embodiments, so that all in connection with FIGS. 5a, 6, 7, 8a and 2 disclosed features also in connection with the devices of FIG. 13, 14, 15 and 16 are disclosed.
  • the device has four outer single cells 16a and four inner single cells 16b.
  • the inner single cells 16b are inscribed in the outer single cells 16a.
  • the outer and inner single cells 16a, 16b have the same shape, and the inner single cells 16b are smaller than the outer single cells 16a.
  • the outer single cells 16a form a sheet-like structure that widens distally.
  • the distal end 13b of the structure is exposed, as clearly seen in FIG.
  • the proximal end 13 a of the structure is connected to the actuating means 11.
  • the connection with the actuating means 11 can be done, for example by gluing or welding, so generally cohesively. Alternatively, by reducing the diameter, the proximal end may be mechanically connected to the actuating means 11, for example by crimping.
  • the device has four cross-shaped main webs 23a.
  • the main webs 23a have a greater width than the other webs.
  • the side webs 23b, 23c of the outer cells 16a set.
  • Two side webs 23b, 23c together with two main webs 23a form an outer single cell 16a.
  • the side webs 23b, 23c are in turn connected to each other and form the cell tip 24.
  • the side webs 23b, 23c engage the distal end of the main webs 23a.
  • the remaining outer individual cells 16a are constructed accordingly.
  • the inner individual cells 16b have side webs 23d, 23e, which also engage the main webs 23a.
  • the side bars 23d, 23e of the inner single cells 16b are connected to each other and form a tip 24.
  • the side bars 23d, 23e engage in the embodiment of FIG. 19 at about halfway up the main webs 23a.
  • a different size distribution between the outer and inner single cells 16a, 16b is possible.
  • more than four outer single cells 16a and corresponding inner single cells 16b may be provided. This also changes the arrangement and number of main webs 23a accordingly.
  • the side bars 23d, 23e may also be referred to as brackets
  • FIG. 19 The side contour of the single segment according to FIG. 19 can be clearly seen in FIG. There, it can be seen that the first axial section 14a, which forms the part of the single segment conically tapering in the proximal direction, is formed by the main webs 23a. In the proximal direction, the first axial section 14a goes into the third axial section 14c via which the connecting means 22 for connecting the
  • first axial section 14a merges into a modified second axial section 24b 'which, in contrast to the preceding embodiments, widens conically outwards with a greater angle of inclination.
  • second axial section 24b which, in contrast to the preceding embodiments, widens conically outwards with a greater angle of inclination.
  • Expansion angle wherein in the region of the second axial portion 14b ', the cone-shaped basic shape of the single segment is maintained.
  • the widening angle is greater in the region of the second axial section 14b 'than in the region of the first
  • Axial section 14a corresponds to the point where the side webs 23b, 23c engage the main web 23a.
  • the first axial section 14a extends substantially rectilinearly.
  • the second axial section 14b ' is curved.
  • the inner single cells 16b protrude radially outwardly beyond the main webs 23a.
  • the side webs 23d, 23e of the inner individual cells 16b protrude beyond the main webs 23a, so that the widening angle in the region of the side webs 23d, 23c is greater than that
  • the side webs 23b, 23c of the outer single cells 16a form a serrated crown with round tips 24 which touches on the conically outwardly extending main webs 23a.
  • FIG. 20 In the embodiment according to FIG. 18, three individual segments 12a, 12b, 12c are provided, each of which is constructed accordingly.
  • the shape of the single segment as shown in FIG. 20 can be combined with the different arrangements of the individual segments, as shown in FIGS. 2-8a or in FIGS. 13-16.
  • FIGS. 21 and 22 show a variant of the exemplary embodiment according to FIG. 18, in which the third axial portion 14c or the connecting means 22 is alternatively configured.
  • the third axial portion 14c and the connecting means 22 is slotted.
  • two diametrically opposed inner individual cells 16b are designed as open cells.
  • the respective other, offset by 90 ° inner single cells 16b are, as in the embodiment of FIG. 18, designed as closed cells.
  • the juxtaposed main webs 23a are connected by a connecting web 23f.
  • the connecting web 23f forms the closed side of the closed inner single cells 16b.

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Abstract

L'invention concerne un dispositif médical pour l'élimination des calculs provenant d'organes de corps creux, au moyen d'éléments de capture compressibles et expansibles (10), pouvant s'ancrer dans un calcul, les éléments de capture (10) étant reliés avec un moyen d'actionnement (11), de façon que ceux-ci soient mobiles par rapport à un conduit d'amenée. Le dispositif est caractérisé en ce que les éléments de capture (10) forment au moins deux segments individuels (12a, 12b, 12c, 12d) articulés, qui sont disposés l'un à la suite de l'autre, le long du moyen d'actionnement (11), et qui sont liés chacun avec le moyen d'actionnement (11), et en ce que les segments individuels (12a, 12b, 12c, 12d) sont compressibles et expansibles indépendamment l'un de l'autre.
PCT/EP2012/052724 2011-02-17 2012-02-16 Dispositif médical pour l'élimination de calculs, et système doté d'un tel dispositif médical WO2012110619A1 (fr)

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