WO2011110316A1 - Dispositif médical pour extraire des concrétions présentes dans des organes corporels creux - Google Patents

Dispositif médical pour extraire des concrétions présentes dans des organes corporels creux Download PDF

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Publication number
WO2011110316A1
WO2011110316A1 PCT/EP2011/001085 EP2011001085W WO2011110316A1 WO 2011110316 A1 WO2011110316 A1 WO 2011110316A1 EP 2011001085 W EP2011001085 W EP 2011001085W WO 2011110316 A1 WO2011110316 A1 WO 2011110316A1
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WO
WIPO (PCT)
Prior art keywords
receiving element
transport channel
microcatheter
guide catheter
expanded state
Prior art date
Application number
PCT/EP2011/001085
Other languages
German (de)
English (en)
Inventor
Giorgio Cattaneo
Original Assignee
Acandis Gmbh & Co. Kg
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Acandis Gmbh & Co. Kg filed Critical Acandis Gmbh & Co. Kg
Publication of WO2011110316A1 publication Critical patent/WO2011110316A1/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
    • A61B17/22—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
    • A61B2017/22038—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 with a guide wire
    • 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
    • A61B2017/22079—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 with suction of debris
    • 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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting

Definitions

  • the invention relates to a medical device for removing concretions from hollow organs of the body according to the preamble of patent claim 1.
  • a medical device for removing concretions from hollow organs of the body according to the preamble of patent claim 1.
  • Such a medical device is known, for example, from WO 2006/031410 A2.
  • a variety of life-threatening, acute illnesses are caused by blood clots or thrombi that form in blood vessels and inhibit blood flow. Due to the blockage of the blood vessel or the impairment of blood flow through the blood clot, downstream tissue areas are no longer sufficiently supplied with nutrients, in particular oxygen. In the affected
  • thrombolysis for example with the help of drugs for thrombolysis, possible, wherein the thrombus or the concretion is generally resolved due to the biochemical reaction with the drug.
  • drug-based thrombolysis is limited to a relatively limited group of patients, since strict criteria must be adhered to for the safe use of this therapy.
  • an efficient drug therapy of blood clots is only in a time window of up to three hours after the occurrence of the event or after the beginning of the first
  • Allow blood clots or thrombi or general calculus by mechanical means Such a device is known for example from WO 2008/088920 A2.
  • a wire element is provided to advance a wire element through a catheter in the region of the vessel closure. The catheter is first pushed through the blood clot. The wire member is then held stationary while the catheter is withdrawn. Thereby, the distal end of the wire member comprising a shape memory material becomes exposed. Due to the shape memory properties, the wire element occupies a previously corkscrew-like shape set in the
  • Clot engages and essentially enters into a positive connection with the blood clot.
  • the blood clot fixed in this way to the wire element can then be pulled out of the blood vessel.
  • the drawback with the known device is that pulling the flared distal end connected to the blood clot of the
  • Wire element is at risk that vessel walls are damaged or injured by the distal end of the wire member. Furthermore, there is the risk that, when the catheter is pushed through the blood clot, particles will escape which will reach downstream blood vessels and other vascular occlusions
  • the known device comprises a receiving basket, which is guided in a compressed state within a supply and aspiration catheter to the treatment site.
  • the delivery and aspiration catheter is longitudinally displaceable in a guide catheter.
  • the guide catheter is guided as close as possible to the treatment area, the relatively large cross-sectional diameter of the guide catheter preventing the guide catheter from being introduced directly into the area of the blood clot.
  • the positioning of the receiving basket directly on the blood clot is therefore via the supply and aspiration catheter.
  • the supply and aspiration catheter is led to just before the blood clot and deployed the receiving basket in front of the blood clot.
  • the guide catheter has a balloon that expands prior to the generation of the negative pressure
  • Blood vessel proximal of the clot in particular in the flow direction before the Clot, temporarily closed fluid-tight.
  • This has the disadvantage that, during the treatment, ie during the removal of the blood clot, a blood flow into blood vessels which branch off in the vessel section between the balloon at the distal end of the guide catheter and the blood clot is prevented.
  • vascular occlusions are usually formed by thrombi in comparatively small and strongly curved blood vessels.
  • catheter diameter is a relatively small catheter diameter.
  • a relatively small catheter diameter makes it difficult to aspirate a blood clot. It is therefore known to shatter the blood clot to the comparatively small aspiration catheter that
  • the thrombus can also be pulled out of the blood vessel with the aid of the receiving basket. Analogous to the
  • Corkscrew-like device there is a risk of injury to the vessel walls.
  • the receiving basket or the wire element of the known devices rub during retraction, ie when removing the thrombus, on the vessel wall.
  • the vessel wall can be injured, which can cause a stenosis or new blood clots.
  • the invention has for its object to provide a medical device for
  • the invention is based on the idea of a medical device for
  • Pickup element is convertible from a compressed state to an expanded state.
  • the receiving element In the expanded state, the receiving element has a distally arranged, axial inlet opening, which is adapted for introducing a concretion in the receiving element.
  • a negative pressure can be generated in order to at least partially store the concrement in the
  • the receiving element further has a
  • Transport channel which extends like a tube between the inlet opening and the micro-catheter in the expanded state of the receiving element and in the expanded state of the receiving element has a cross-sectional diameter which is greater than a diameter of the microcatheter.
  • the transport channel comprises a fluid-tight cover, which at a proximal end of
  • Transport channel at least such an opening, that the transport channel with the guide catheter is fluid-connectable.
  • the guide catheter is fluidly connected to a suction device or fluid-connected to the negative pressure in the
  • the invention is based on the idea, the receiving element with a
  • the transport channel is formed like a tube.
  • the transport channel forms in the expanded state, a flexible tube with a fluid-tight envelope, which is fluidly connected to the guide catheter.
  • the guide catheter is with a
  • Absaugvorraum connectable or connected, so that via the guide catheter through the at least one opening in the cover of the transport channel in the transport channel or generally in the receiving element, a negative pressure for sucking the concretion can be generated.
  • the microcatheter can have cross-sectional diameter, so that an efficient extraction performance is achieved.
  • the microcatheter can be a relatively small
  • the fluid-tight cover can also be dispensed with a temporary interruption of blood flow, for example by a balloon in the region of the distal end of the guide catheter.
  • the fluid-tight cover causes the negative pressure within the body cavity to be effective primarily between the inlet port and the calculus.
  • a distal end of the receiving element in the expanded state seals against a vessel wall of the body cavity.
  • the transport channel may advantageously comprise a cross-sectional diameter which is smaller than the cross-sectional diameter of the hollow body member, so that between the
  • Transport channel and the hollow body organ an annular space is formed, in which a body fluid can flow.
  • the transport channel has a cross-sectional diameter such that the
  • Transport channel rests against a vessel wall of the body hollow organ.
  • a further advantage of the device according to the invention is that during the aspiration or the aspiration detaching concretion particles are guided through the transport channel to the comparatively large-lumen guide catheter.
  • the calculus particles are thus reliably removed from the body cavity. Since the cross-sectional diameter of the entire suction line formed by the guide catheter and the receiving element is comparatively large, concretion particles are prevented from blocking the suction line. This ensures that the concretion in the body cavity constantly a negative pressure acts. Due to the constantly acting negative pressure, it is avoided that detaching concretion particles move into branching body cavities and lead there to further closures or blockages.
  • the transport channel thus bridges the distance between the guide catheter and the concretion, which is sucked through the transport channel into the guide catheter becomes.
  • the receiving element can therefore be kept stationary in the device according to the invention. Retraction of the receiving element to remove the calculus is not required. Appropriately, to remove the receiving element after treatment rather the microcatheter on the
  • Shucked receiving element to compress the receiving element or to convert in the compressed state. Therefore, a relative movement does not take place between the receiving element and the hollow body organ, but between the receiving element and the microcatheter. The risk of injuring the hollow body organ, in particular vessel walls of the hollow body organ, is thus reduced.
  • the Device is provided a guide wire which is connected to the proximal end of the receiving element.
  • the guidewire may be longitudinally displaceable within the microcatheter.
  • the guidewire facilitates handling of the receiving element. In particular, a user can do the
  • the guide wire allows the stationary fixation of the expanded receiving element, so that the receiving element is retractable by a relative movement between the guide wire and the microcatheter in the microcatheter.
  • the receiving element can be held stationary by means of the guide wire from outside the body to be treated, while the microcatheter is pushed in the distal direction over the receiving element.
  • the receiving element expanded in the body cavity can thus be converted into the compressed state and placed in the microcatheter.
  • the device is also advantageously used for the removal of concretions from relatively small hollow organs, such as cerebral blood vessels.
  • the receiving element may have a net-like support structure.
  • the reticulated support structure can advantageously ensure a radial stability of the receiving element, in particular of the transport channel, in the expanded state, so that the negative pressure acting within the receiving element does not lead to a collapse of the receiving element or the transport channel.
  • the reticulated grid structure advantageously comprises a wire mesh.
  • wire mesh or a braided grid structure or a mesh
  • sufficient radial stability of the receiving element is achieved and on the other hand, a comparatively high flexibility of the receiving element
  • the wire mesh preferably has a braiding angle which is at least 30 °, in particular at least 40 °, in particular at least 45 °, in particular at least 50 °, in particular at least 55 °, in particular at least 60 °.
  • a braiding angle which is at least 30 °, in particular at least 40 °, in particular at least 45 °, in particular at least 50 °, in particular at least 55 °, in particular at least 60 °.
  • the wire mesh may have a braiding angle which is at most 70 °, in particular at most 60 °, in particular at most 50 °, in particular at most 45 °, in particular at most 40 °, in particular at most 30 °, in particular at most 20 °.
  • Such braiding angles allow a high flexibility of the receiving element, so that the receiving element adapts well to vessel curvatures.
  • the receiving element can be used in this way in particularly highly curved vessel sections.
  • the effect of "foreshortening" ie the shortening of the lattice structure during expansion, is reduced with the aforementioned braiding angles, thus facilitating the accurate positioning of the receiving element.
  • the wire elements which overlap or intersect in intersection areas each have an axial direction with respect to one another
  • Receiving element extending lines at an acute angle.
  • the braiding angle in the context of the present application thus relates to the angle between a wire element and a projection of the axis of rotation of the hose-like receiving element in a wall plane in which the wire element extends.
  • the determination of the braiding angle takes place in the idle state or expanded state of the receiving element. Due to the geometric displacement of the wire elements upon compression of the receiving element, the angle between the axially extending straight line and the wire elements at the transition from the expanded to the compressed state changes.
  • the braiding angle refers to the angle provided during braiding of the wire mesh between the straight line extending in the axial direction and the wire elements.
  • the braiding angle therefore essentially corresponds to the angle between the straight line running in the axial direction and a wire element in the expanded state of the receiving element.
  • the receiving element in the expanded state comprises a radially expanded, in particular basket-like, suction, which is connected to the transport channel.
  • the suction section may have a fluid-tight cover.
  • the fluid-tight cover may extend into the suction section.
  • the suction section may be expandable such that the
  • Body hollow organ is formed, which is acted upon by the negative pressure.
  • the demarcated aspiration space is via the transport channel and the
  • the suction section comprises the axial inlet opening of the receiving element.
  • Aspiration section may be funnel-shaped. Specifically, the
  • Inlet opening have a cross-sectional diameter which is greater than a
  • Cross-sectional diameter of the transport channel is.
  • the suction section can form a flowing transition between the inlet opening and the transport channel. Due to the different cross-sectional diameter between the inlet opening and the transport channel ensures that on the one hand, the aspiration space between the inlet opening and the concretion is defined fluid-tight and On the other hand, a supply of nutrients or body fluids in hollow organs of the body, which branch off between the inlet opening and the guide catheter, is ensured. It is particularly provided that the transport channel a
  • Cross-sectional diameter which is smaller than the cross-sectional diameter of the hollow body organ, in which the transport channel is arranged in use. In this way, an annular space is formed between the hollow body organ and the transport channel, which allows the supply of body fluids, in particular blood, in branching body hollow organs.
  • the cover of the transport channel can seal in the expanded state of the receiving element against the inner surface of the guide catheter, so that a continuous fluid-tight suction line from the guide catheter to the
  • Inlet opening is provided in the expanded state of the receiving element.
  • the sealing of the cover of the transport channel with the inner surface of the guide catheter ensures that the negative pressure transmitted by the guide catheter from the suction device is conducted directly into the receiving element, in particular the transport channel. A pressure loss at the
  • the transport channel may have a length which is at least 4 times, in particular at least 6 times, in particular at least 8 times, in particular at least 10 times, in particular at least 15 times, in particular at least 20 times, in particular at least 25 times, in particular at least 30 times, in particular at least 40 times, in particular at least 50 times, in particular at least 70 times, in particular at least 100 times, an inner diameter of
  • the transport channel or the receiving element has an absolute length which is at least 5 cm, in particular at least 7 cm, in particular at least 10 cm, in particular at least 15 cm, in particular at least 20 cm.
  • the abovementioned values essentially correspond to the distance of the guide catheter from a concretion, in particular a thrombus in one Blood vessel, this distance being determined by the anatomy of the blood vessels.
  • a guide catheter can be due to the relatively large
  • the guide catheter may have an inner diameter which is at least 0.8 mm, in particular at least 1.0 mm, in particular at least 1.2 mm,
  • Guide catheter having an inside diameter which is at most 2.4 mm, in particular at most 2.2 mm, in particular at most 2.0 mm, in particular at most 1.8 mm, in particular at most 1.6 mm, in particular at most 1.4 mm, in particular at most 1 , 2 mm, in particular not more than 1.0 mm.
  • the appropriate values for the inner diameter of the guide catheter are dependent on the particular location of the medical device and are of the
  • an inner diameter of about 1.5 mm of the guide catheter is sufficient, for example, to efficiently aspirate a thrombus with a cross-sectional diameter of about 3 mm.
  • the feedability of the guide catheter can be increased.
  • a distal holding element is provided, which can be converted from a compressed state to an expanded state.
  • the distal retaining element is retractable into the microcatheter.
  • the retaining element is in
  • the holding element can be advantageously used to
  • the distal holding element can be connected to the receiving element and / or the guide wire.
  • the distal holding element can be actuated by the guide wire.
  • the distal support member may be connected or connectable to a separate actuator.
  • the distal holding element can be used in this way to push a concretion mechanically into the receiving element. It is therefore possible that the holding element performs a dual function, namely on the one hand to retain peeling concretion particles and on the other hand to move the concretion mechanically into the receiving element. The mechanical movement of the
  • Receiving element may additionally or separately for suction through the
  • Holding element to be fluidly connected to the guide catheter or the suction device, so that in the region of the holding element, specifically between the holding element and the concretion a negative pressure can be generated.
  • an overpressure can be generated, which drives the concretion into the inlet opening of the receiving element.
  • the invention is based on the idea of a medical device for removing concretions from hollow organs of the body with a guide catheter, a longitudinally displaceably arranged microcatheter in the guide catheter and a retractable into the microcatheter
  • Specify receiving element which is convertible from a compressed state to an expanded state and in the expanded state has a distally disposed axial inlet opening.
  • the axial inlet opening is adapted to introduce a concretion in the receiving element.
  • Receiving element has a transport channel which in the expanded state of the receiving element like a tube between the inlet opening and the
  • Microcatheter extends and in the expanded state of the receiving element has a cross-sectional diameter which is greater than a diameter of the
  • the transport channel has at least one opening at a proximal end in such a way that the transport channel can be connected to the guide catheter.
  • a holding element is arranged, which is connected to an actuating element such that the holding element is movable relative to the receiving element in order to introduce a concretion in the axial inlet opening.
  • the retaining element is adapted to fix the concretion and to move into the inlet opening. In this case, the retaining element can grasp or fix the concrement both laterally, distally or proximally.
  • the holding means allows a mechanical movement of the concretion into the inlet opening of the receiving element.
  • a pressure in particular a fluid pressure, can be transmitted to the concretion via the holding element, which causes the movement of the concretion into the receiving element.
  • Actuator may be, for example, a guide wire.
  • Actuator preferably extends through the microcatheter or guide catheter.
  • the holding element can be retractable both in the microcatheter, so also in the guide catheter.
  • Encapsulation of the calculus takes place essentially by a movement of the retaining element. This reduces the risk of injury to the vessel walls.
  • Fig. 1 to 3 are each a side view of a medical invention
  • Fig. 4 is a side view of a medical device according to the invention according to a preferred embodiment in use.
  • pressure does not only mean positive pressures (overpressure), but explicitly also negative pressures (negative pressure).
  • overpressure is a pressure which is higher than the pressure prevailing in the vessel.
  • negative pressure is a pressure that is lower than the pressure prevailing in the vessel, in particular lower than a pressure within a vessel section, which is arranged distally of the concretion 40.
  • the invention is particularly suitable for removing clots or thrombi from blood vessels. Although the invention is described below using the example of the removal of thrombi, other uses of the invention
  • Distally arranged objects are accordingly arranged further away from the user or operator of the device with respect to a proximally arranged object.
  • FIG. 1 to 3 successive stages during the discharge of the receiving element 10 from the micro-catheter 20 are shown.
  • the receiving element 10 is disposed completely within the microcatheter 20 before discharge.
  • the receiving element 10 has the compressed state in the arrangement within the micro-catheter 20.
  • the following description of the structure of the medical device relates essentially to the at least partially expanded state of the receiving element 10, which occurs during the discharge of the receiving element 10 from the micro-catheter 20.
  • the receiving element 10 has an essentially rotationally symmetrical shape in the expanded state. In a distal end region of the receiving element
  • a suction portion 15 is formed, which has a substantially funnel-like shape.
  • the suction section 15 opens in the distal direction and delimits an axial inlet opening 11 of the receiving element 10.
  • the funnel shape of the suction section 15 is preferably adapted such that the inlet opening
  • the funnel-shaped suction section 15 seals against the vessel wall of the blood vessel 45.
  • the suction section 15 is followed by a transport channel 12 in the proximal direction.
  • the transport channel 12 is fixedly connected to the suction section 15.
  • the transport channel 12 is integrally formed with the intake section 15. The transition between the intake section 15 and the
  • Transport channel 12 may be formed substantially continuously or fluently.
  • the transport channel 12 can be transferred as part of the receiving element 10 from a compressed state to an expanded state.
  • the transport channel 12 has a tube-like shape at least in the expanded state.
  • the transport channel 12 In the expanded state, the transport channel 12 has a cross-sectional diameter which is greater than a cross-sectional diameter in the compressed state, in particular greater than a cross-sectional diameter of the microcatheter 20.
  • the transport channel 12 in the expanded state has a cross-sectional diameter which is smaller than the inner diameter of the blood vessel 45. In this way, between the transport channel 12 and the blood vessel 45 or generally the
  • Body hollow organ an annulus kept, so that body fluid, especially blood, freely from proximal to distal at least to the area of
  • Suction section 15 can flow. A supply of branching vessels with blood or nutrients is thus ensured during the treatment, ie during the removal of the concretion or concretely a thrombus from a blood vessel.
  • the transport channel 12 extends to a proximal end of the
  • Receiving element 10 wherein the receiving element 10 forms a taper 16 which limits the receiving member 10 at the proximal end axially.
  • the taper 16 is connected to a guide wire 21 which extends through the microcatheter 20 and is axially displaceable within the microcatheter 20 ( Figure 5).
  • the connection between the receiving element 10, in particular the taper 16, and the guide wire 21 may be detachable.
  • the receiving element 10 may comprise a net-like support structure.
  • the support structure may be formed substantially stent-like.
  • the support structure may be a laser-cut lattice structure or a braided
  • the laser-cut lattice structure is preferably formed from a tubular raw material. It is also possible that the
  • laser-cut lattice structure is made of a flat raw material, which is transferred after structuring in a cylindrical or generally rotationally symmetrical shape, in particular bent, is.
  • Grid mesh for the receiving element 10. are one or more
  • Wire elements substantially helically about a common longitudinal axis, in particular the longitudinal axis of the rotationally symmetrical shape of the
  • Wire sections of a wire element are wound in opposite directions about the longitudinal axis and form at least one crossing point.
  • Wire elements intersect, with one wire element passing over the other.
  • a type of braid in which one wire element at a crossing point intersects another wire element is called a 1-over-1 weave. It is also possible for a wire element to cross over two further wire elements in a crossing point, so that an L-over-2 weave is formed.
  • Other possible lichens are
  • I-over-3 weave I-over-4 weave
  • 2-over-I weave 2-over-2 weave
  • 3-over-I weave 3-over-2 weave
  • 4-on-2-braiding I-over-3 weave, I-over-4 weave, 2-over-I weave, 2-over-2 weave, 3-over-I weave, 3-over-2 weave, or 4-on-2-braiding.
  • the braided wire mesh or mesh can both the suction section
  • the receiving element 10 may have a total of a support structure of a grid mesh. This means that the
  • Suction section 15, the transport channel 12 and the taper 16 have the grid mesh. It is also possible for the grid mesh or at least one or more wires of the grid mesh to form the guide wire 21.
  • the mesh may be at the proximal end of the receiving element 10, ie in the region of the taper
  • the guide wire 21 may be formed by at least one wire element, which also forms the grid of the receiving element 10.
  • At least the transport channel 12 of the receiving element 10 has a fluid-tight cover 13.
  • the transport channel 12 is provided in particular with a cover 13 or with a coating or a Covering, with the
  • Receiving element 10 may be formed integrally or in one piece.
  • the cover 13 forms a fluid-tight wall of the transport channel 12.
  • the cover 13 may be produced by sputtering or another coating method as a cantilevered support structure.
  • the cover 13 comprises a
  • the cover 13 may be fixedly connected to the net-like support structure or the mesh of the transport channel 12. In this case, the cover 13 can be arranged both on an inner surface of the transport channel 12, as well as on an outer surface or an outer periphery of the transport channel 12. The cover 13 may extend over the entire receiving element 10 or cover the receiving element 10 only partially, in particular in the region of the transport channel 12. Preferably, the transport channel 12 is completely provided with the cover 13.
  • the transport channel 12 forms, in particular, a flexible hose which is completely closed fluid-tight on the circumference.
  • the transport channel 12 has in the expanded state substantially one
  • the cover 13 is made of a fluid-tight material that is sufficiently tight to withstand a pressure difference between the inside and outside of the cover 13.
  • Receiving element 10 have a cup-like shape, which is completely covered fluid-tight.
  • the cup-like shape is in the region of the suction section 15
  • the suction section 15 thus fulfills a support function for the blood vessel 45.
  • the suction section 15 can provide an increased radial force, for example by a mesh with a comparatively large braiding angle .
  • the suction portion 15 comprises the cover 13, so that the suction portion 13 against the vessel wall of the
  • the suction section 15 may have a free grid structure.
  • fluids in the context of the present application refers not only to liquids, but also to gases.
  • the cover 13 has at least one opening 14.
  • the opening 14 may extend substantially axially. This means that the cover 13 forms a terminal edge, which extends in the region of the taper 16 in the circumferential direction around the receiving element 10.
  • the axial opening 14 may be the opening of the hollow cylindrical shape of the transport channel 12 at the proximal end of the
  • Transportabkanals 12 and at the distal end of the taper 16 correspond. This means that the cover 13 can extend over the transport channel 12 as far as the taper 16. At least in sections, taper 16 has no cover 13. Rather, at least part of the taper 16 comprises a free one
  • Grid structure in particular a free grid mesh.
  • Cover 13 extend in the region of the taper 16, wherein the cover 13 has at least one opening 14 which extends along the circumference of the
  • the opening 14 may be aligned laterally or radially.
  • the taper 16 may have a substantially hollow cone-like shape.
  • the opening 14 may be formed in the conical surface, which is covered by the cover 13 and covered.
  • the conical surface can also be interrupted at least in sections so that a frustoconical recess or opening 14 is formed in the region of the taper 16.
  • a circumferential strip of the cover 14 may be left open in the region of the taper 16, so that at least in sections the support structure of the
  • Rejuvenation 16 and generally the receiving element 10 is exposed and thus
  • Openings 14 are provided.
  • Guide catheter 30 is arranged.
  • the receiving element 10 is partially disposed in the discharged state within and partially outside of the guide catheter 30.
  • the suction section 15 and the transport channel 12 are arranged outside of the guide catheter 30.
  • the taper 16, however, is disposed within the guide catheter 30.
  • the cover 13 extends at least partially into the region of the taper 16 and fluid-tightly seals with a distal axial end of the guide catheter 30, as shown in detail in FIG.
  • the opening 14 or the plurality of openings 14 in the region of the taper 16 establish a fluid connection between the guide catheter 30 and the transport channel 12 or generally the receiving element 10.
  • the guide catheter 30 has substantially a cross-sectional diameter sufficient to permit efficient aspiration, i. Extraction, a concretion 40, in particular thrombus allow.
  • the guide catheter 30 includes a larger cross-sectional diameter than the microcatheter 20 that is longitudinally slidable within the guide catheter 30. Within the micro-catheter 20, the guide wire 21 is guided longitudinally displaceable.
  • the receiving element 10 is also disposed within the microcatheter 20 in the compressed state.
  • the receiving element 10 may at least one in the region of the taper 16
  • Separating element 17 include, as indicated in Fig. 5.
  • the separating element 17 may be formed, for example, by at least one wire element of the grid mesh.
  • the separating element 17 is preferably formed between two openings 14 or intersects an opening 14 in the cover 13.
  • the separating element 17 may comprise a cutting area.
  • the separating element 17 may have a cutting edge, which is aligned substantially in the direction of the transport channel 12.
  • the separating element 17 is adapted such that a concretion 40 or a
  • Thrombus which is sucked or aspirated via the transport channel 12 into the guide catheter 30, is cut or separated in the region of the taper 16. In this way the aspiration performance is increased.
  • the separator 17 may extend substantially in the circumferential plane of the taper 16. Alternatively it can be provided that in the region of the taper 16 radially inwardly directed separating elements 17 are arranged.
  • the separating elements 17 may be aligned in a cross shape. For example, the separating elements 17 in one
  • Cross-sectional plane of the taper 16 may be arranged like a wheel spoke.
  • the medical device additionally has a holding element 50, which is arranged distally distanced from the inlet opening 11 of the receiving element 10.
  • Retaining member 50 has a cap-like shape with a tip 51 extending in the distal direction.
  • the holding element 50 is provided with a
  • Actuator 52 is connected.
  • the actuator may extend through the receiving member 10 and the microcatheter 20 and be operable from outside the body or extracorporeal.
  • that can Actuator be slidable in the axial direction, so that the distance of the holding member 50 is adjustable from the inlet opening 11.
  • the expanded holding element 50 can be pulled in the proximal direction, so that a between the receiving element 10 and the
  • Holding element 50 arranged concretion 40 is mechanically pulled into the receiving portion 10. The mechanical inclusion of the concretion 40 in the
  • Receiving element 10 can be supported by the aspiration, ie the negative pressure which is generated in the extracorporeal suction device and acts on the concretion 40 proximally via the guide catheter 30 and the receiving element 10.
  • the holding element 50 can also be connected to the receiving element 10, in particular the intake section 15.
  • the receiving element 10 and the holding element 50 are preferably positioned such that the strand 52 is arranged at the level of the thrombus or concretion 40.
  • the retaining element 50 has a support structure, which may comprise a wire mesh.
  • the support structure may also comprise a laser-cut lattice structure analogously to the construction of the receiving element 10.
  • the holding element 50 may also have a cover 13.
  • the cover 13 of the holding member 50 may be a
  • the holding element 50 may be designed like a sieve. In general, the holding element 50 in such a way
  • the holding member 50 can flow through and on the other hand concretion particles are retained.
  • the receiving element 10 and / or the holding element 50 may have marker elements.
  • the marker elements preferably comprise a radiopaque material, so that the position of the receiving element 10 or of the holding element 50 can be controlled under X-ray control. This applies to all embodiments.
  • Guide catheter 30 may have a stop.
  • the receiving element 10 at the proximal end in particular in the region of the taper 16 or between the taper 16 and the transport channel 12 or at a proximal end of the transport channel 12, a stop, so that the Receiving element 10 is prevented from completely emerge from the guide catheter 30.
  • the taper 16 is held within the guide catheter 30.
  • the microcatheter 20 may also include a stop which cooperates with a stop mating member within the guide catheter 30 to limit the displaceability of the microcatheter 20 within the guide catheter 30. In this way, it is ensured that the taper 16 between the distal axial end of the guide catheter and the distal axial end of the
  • Microcatheter be arranged and the transport channel 12 with the guide catheter 30 fluidly connected.
  • the guide catheter 30 is first guided, preferably with the aid of a guide wire 21, into a vessel section of the body cavity or blood vessel 45 to be treated, which is arranged away from the concretion 40.
  • the flow area of the vessel portion in which the guide catheter 30 is placed is usually larger than the flow area of the vessel portion closed by the calculus 40.
  • the relatively large cross-sectional diameter of the guide catheter 30 prevents advancement of the guide catheter 30 into the relatively small blood vessel 45 occluded by the concretion 40.
  • the guide catheter 30 is positioned farther away from the calculus 40 in a vessel section having a larger cross-sectional diameter than the guide catheter 30. Due to the anatomical conditions of the catheter
  • the guide catheter 30 is preferably positioned about 5 cm to 20 cm in front of the concretion 40 and proximal to the concretion 40.
  • the guide catheter 30 then guides the microcatheter 20 to the proximal end of the concretion 40 or thrombus. It can be a
  • Guide aids (not shown), in particular an additional guide wire, are used, wherein the guide means first by the
  • Guide catheter 30 is pushed to the calculus 40.
  • Guide aid is pushed to the microcatheter 20 to the calculus 40 and the guide aid is then removed. In a next step that will be
  • Receiving element 10 is guided to the distal tip of the micro catheter 20.
  • the receiving element 10 by the guide wire 21, with the Receiving element 10 is connected, pushed through the micro-catheter 20.
  • the receiving member 10 Once the receiving member 10 has reached the tip of the microcatheter 20 and the proximal end of the concretion 40, the microcatheter 20 is pulled back in the proximal direction.
  • the receiving element 10 is held stationary at the same time by an extracorporeal fixation of the guide wire 21. It is also possible the
  • Microcatheter 20 will dismiss the receiving element 10. This means that the receiving element 10 successively transitions from the compressed state to the expanded state.
  • the suction section 15, including the inlet opening 11 (FIG. 1) first unfolds or expands.
  • the suction section 15 seals against the vessel wall of the blood vessel 45.
  • the suction section 15 preferably has a fluid-tight cover 13
  • the suction section 15 sealing against the vessel wall forms a closed aspiration space with the concretion 40 closing the blood vessel 45.
  • the transport channel 12 of the receiving element 10 is released, as shown in FIG.
  • the transport channel 12 is transferred to the expanded state. Due to the net-like
  • the transport channel 12 has a high flexibility and adapts to the course of the body hollow organ or blood vessel 45.
  • the receiving element 10 in particular the transport channel 12, the micro catheter 20 and the guide catheter 30 in
  • Microcatheter 20 is retracted until the taper 16 is located between the distal end of the microcatheter and the distal axial end of the guide catheter, with the opening 14 in the taper 16 providing fluid communication between the guide catheter 30 and the transport channel 12.
  • the aspiration is accomplished by the guide catheter 30.
  • the thrombus or concretion 40 is aspirated by the receiving element 10 and then passes into the guide catheter 30.
  • the guide catheter 30 is connected or connectable to a suction device at a proximal end, in particular extracorporeally.
  • a negative pressure is generated by the guide catheter 30, the opening 14 in the taper 16, the transport channel 12 and the suction section 15 to act in the aspiration space, which is formed between the expanded suction portion 15 and the concretion 40.
  • the concretion 40 is drawn into the intake section 15.
  • the aspirated concretion 40 is then sucked over the transport channel 12 to the guide catheter 30, which is fluidly connected via the opening 14 in the cover 13 with the transport channel 12.
  • the concretion 40 is removed from the body via the guide catheter 30. This process will continue until the
  • the receiving element 10 is in the fully released state, i. in use, shown.
  • the receiving element 10 In the use state, which is described in the context of the application as a fully released state, the receiving element 10 is disposed completely outside of the micro-catheter 20.
  • the distal end of the microcatheter 20 and thus also the proximal end of the receiving element 10, in particular the taper 16, are arranged within the guide catheter 30.
  • the cover 13 of the transport channel 12 seals against an inner surface of the guide catheter 30, so that a fluid channel is formed which extends from the extracorporeally arranged suction device via the guide catheter 30 and the transport channel 12 into the suction section 15 or to the concretion 40 ,
  • the fluid connection between transport channel 12 and guide catheter 30 can be clearly seen in FIG.
  • the receiving element 10 is retracted into the microcatheter 20, wherein the
  • Receiving element 10 again assumes the compressed state.
  • the construction of the receiving element 10 allows the microcatheter 20 to be pushed over the receiving element 10 in the distal direction. A movement of the receiving element 10 in the proximal direction, which can lead to injuries of the vessel wall is thus avoided.
  • the microcatheter 20 may be both centered and decentered within the guide catheter 30.
  • the microcatheter 20 may slide laterally along an inner surface of the guide catheter 30.
  • the medical device offers the following advantages:
  • the entire thrombus is aspirated, even if the thrombus consists of several areas.
  • a distal embolism ie a vascular occlusion of distal body organs, is avoided.
  • the receiving element 10 is not pulled along the vessel wall, but the microcatheter 20 is placed over it, so that the risk of injury to vessel walls is reduced.
  • Receiving element 10 and the holding member 50 may by sputtering and
  • materials for the thin-film technique as well as wire materials are nickel-titanium alloys, chromium-cobalt alloys such as Phynox, Elgiloy, stainless steels (e.g., 316 LVM), platinum and / or
  • Platinum alloys in particular platinum-iridium alloys, magnesium and / or magnesium alloys and tungsten or tungsten alloys, in particular titanium-tungsten alloys or tungsten-rhenium alloys in question.
  • materials such as magnesium, iron or tungsten and their alloys can be used, which have bioadsorbable properties. It is also possible to use plastic filaments such as Dynema to form the support structure.
  • the thin-walled functional elements described can also be made of other plastics, in particular polyurethane or bioresorbable plastics.

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Abstract

L'invention concerne un dispositif médical pour extraire des concrétions (40) présentes dans des organes corporels creux, comprenant un cathéter de guidage (30), un micro-cathéter (20) disposé dans le cathéter de guidage (30) de manière à pouvoir se déplacer longitudinalement et un élément de réception (10) qui peut être inséré dans le micro-cathéter (20), qui peut passer d'un état comprimé à un état dilaté, et qui présente, à l'état dilaté, une ouverture d'entrée axiale (11) agencée de manière distale et adaptée pour l'introduction d'une concrétion (40) dans l'élément de réception (10), une dépression pouvant être produite dans la zone de l'élément de réception (10) afin de déplacer au moins partiellement la concrétion (40) dans l'élément de réception (10). L'invention est caractérisée en ce que l'élément de réception (10) présente un tube de transport (12) qui, lorsque l'élément de réception (10) est à l'état dilaté, s'étend à la manière d'un tuyau flexible entre l'ouverture d'entrée axiale (11) et le micro-cathéter (20), et présente un diamètre de section transversale supérieur au diamètre du micro-cathéter (20). Le tube de transport (12) comporte un élément de recouvrement (13) étanche aux fluides dans lequel est ménagée au moins une ouverture (14) à une extrémité proximale du tube de transport (12), de sorte que le tube de transport (12) peut être en communication fluidique avec le cathéter de guidage (30), le cathéter de guidage (30) étant ou pouvant être en communication fluidique avec un dispositif d'aspiration afin de produire une dépression dans la zone de l'élément de réception (10).
PCT/EP2011/001085 2010-03-10 2011-03-04 Dispositif médical pour extraire des concrétions présentes dans des organes corporels creux WO2011110316A1 (fr)

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DE201010010848 DE102010010848A1 (de) 2010-03-10 2010-03-10 Medizinische Vorrichtung zum Entfernen von Konkrementen aus Körperhohlorganen

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