WO2011157362A1 - Dispositif et procédé pour éliminer les thrombus - Google Patents

Dispositif et procédé pour éliminer les thrombus Download PDF

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Publication number
WO2011157362A1
WO2011157362A1 PCT/EP2011/002744 EP2011002744W WO2011157362A1 WO 2011157362 A1 WO2011157362 A1 WO 2011157362A1 EP 2011002744 W EP2011002744 W EP 2011002744W WO 2011157362 A1 WO2011157362 A1 WO 2011157362A1
Authority
WO
WIPO (PCT)
Prior art keywords
ultrasonic
waveguide
ultrasonic waveguide
oscillating head
arrangement according
Prior art date
Application number
PCT/EP2011/002744
Other languages
German (de)
English (en)
Inventor
Helmut Roppelt
Original Assignee
Hpf Gmbh
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 Hpf Gmbh filed Critical Hpf Gmbh
Publication of WO2011157362A1 publication Critical patent/WO2011157362A1/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
    • A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00137—Details of operation mode
    • A61B2017/00154—Details of operation mode pulsed
    • A61B2017/00172—Pulse trains, bursts, intermittent continuous operation
    • 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
    • A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22014—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
    • A61B2017/22015—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0043—Ultrasound therapy intra-cavitary

Definitions

  • the invention relates to an arrangement and a method for the removal of thrombi from veins or blood vessels according to the preamble of claim 1.
  • a thrombus in a vein or a blood vessel of the human or animal body is removed by inserting a rod-shaped ultrasonic waveguide with a vibrating head arranged thereon into the vein or the blood vessel and bringing it into contact with the thrombus.
  • a rod-shaped ultrasonic waveguide with a vibrating head arranged thereon into the vein or the blood vessel and bringing it into contact with the thrombus.
  • the waveguide with ultrasonic pulses of a fixed predetermined frequency of the oscillating head is excited to transverse oscillations or bending oscillations, which lead to destruction of the thrombus.
  • the material removed from the thrombus is sucked out of the vein or the blood vessel via a catheter tube surrounding the waveguide.
  • the device described has the disadvantage that the removal of a thrombus takes a comparatively long time, since the resonance frequency, and thus the amplitude with which the oscillating head acts on the thrombus, is greatly influenced by the instantaneous curvature of the waveguide in the vein or the blood vessel which changes slightly during insertion and movement of the waveguide. For this reason, it is necessary with the aforementioned device a frequent control of the position of the oscillating head in the vein or the blood vessel by X-rays, which leads to a relatively high radiation exposure.
  • an arrangement for the removal of thrombi from veins or blood vessels of the human or animal body comprises a rod-shaped ultrasonic waveguide having at its first end a thrombus acting on the oscillating head or working head and which is coupled at its second end to an ultrasound generator , which sets the ultrasonic waveguide in mechanical longitudinal vibrations.
  • the inventive arrangement is characterized in that the ultrasonic waveguide consists of a resilient material and is acted upon by the ultrasonic generator with a series of ultrasonic pulses whose frequency in a range of 0.5% to 5% compared to the value of the respective mechanical natural frequency of Ultrasonic waveguide and oscillating head is varied.
  • the respective desired natural oscillation of the waveguide with the attached oscillating head can be stimulated very accurately even if the mechanical natural frequency due to one or more different radii of curvature of the waveguide within the vein or the blood vessel relative to the rectilinear extending waveguide changes.
  • This allows the number of angiographic cycles, i. the cycles in which the position of the oscillating head within the vein or the blood vessel must be monitored by X-ray recordings, advantageously reduce overall, whereby the radiation load of the patient decreases.
  • a passage opening is formed which has an opening width which is greater is as the outer diameter of a guidewire.
  • the through-bore which may for example have an inner diameter of about 0.5 mm, is hereby arranged according to a first embodiment of the invention substantially parallel to the longitudinal axis of the rod-shaped ultrasonic waveguide in the oscillating head, whereby the arrangement according to the invention, in particular in relatively straight running veins or blood vessels with a reduced force and reduced stress on the guidewire through the vein or blood vessel.
  • the center of the throughbore is here preferably offset by 0.3 to 0.5 mm with respect to the longitudinal axis of the ultrasonic waveguide, resulting in an advantageous guidance of the head along the wire, in conjunction with the club-like oscillating head and the rod-shaped ultrasonic waveguide that the risk exists that the remaining material thickness between the outside of the oscillating head and the through hole is too small to ensure the necessary strength.
  • the unbalanced mass distribution produced by the introduction of the through-hole into the otherwise preferably rotationally symmetrical oscillating head supports the oscillatory behavior of the oscillating head in the transverse direction, ie. in the bending direction of the waveguide.
  • the through-hole is arranged at an angle inclined to the longitudinal axis of the ultrasonic waveguide, which is based on the longitudinal axis of the preferably solid rod-shaped ultrasonic waveguide in a range of 5 ° and 20 °.
  • the ultrasonic waveguide is preferably made of a solid rod-shaped material, in particular of stainless steel or titanium, and has a varying diameter over its length.
  • the diameter of the ultrasonic waveguide, starting from the ultrasound generator toward the center of the waveguide is reduced from a value of 1.6 mm to a value of 0.7 mm and then preferably once again to a value of only 0.5 mm before the diameter in the direction of the oscillating head then increases again up to 1, 6 mm in the area of the oscillating head.
  • a waveguide and oscillating head arrangement which is preferably still surrounded by a tubular section which extends to a distance of, for example, 1 cm from the oscillating head and serves to suck off the removed material, is inserted into a core or a blood vessel which is partially or completely occluded by a thrombus.
  • the method is characterized in that the ultrasound generator impinges on the ultrasonic waveguide during contact with the thrombus with a first and a second packet of ultrasonic pulses corresponding to a first and a second mechanical natural frequency of the ultrasonic waveguide and oscillating head, the first Natural frequency is chosen so that the oscillating head is placed in longitudinal oscillations.
  • the second natural frequency is chosen in such a way that the oscillating head performs a transverse oscillation, ie a bending oscillation.
  • the two vibration modes have in common that the frequency of the vibration transmitted from the ultrasonic generator to the ultrasonic waveguide is continuously changed in a range of, in particular, 0.5% to 5% of the value of the respective first and second natural frequencies around that value, to obtain a maximum oscillation amplitude of the oscillating head.
  • Fig. 1 is a schematic side view of the inventive arrangement within a vein before processing a thrombus, wherein in the vein is a guide wire along which the oscillating head is guided.
  • an inventive arrangement 1 for removing thrombi 2 from veins or blood vessels 4 of the human or animal body comprises a rod-shaped ultrasonic waveguide 6 having at its first end 8a a vibrating head 10, which on the thrombus 2 acts.
  • an ultrasonic wave generator 12 is mounted, which comprises an ultrasonic transducer 12a, for example, a piezoelectric crystal, which sets the ultrasonic waveguide 6 and the attached oscillating head 10 in longitudinal mechanical vibrations, the propagate from the ultrasonic wave generator 12 in the direction of the longitudinal axis of the ultrasonic waveguide 6 indicated by the reference numeral 14.
  • the ultrasonic transducer 12a is acted upon by an ultrasonic frequency generator 12b in a known manner with an electrical alternating voltage, for example a sine voltage having a predetermined frequency ⁇ , which corresponds to one of the numerous natural frequencies of the arrangement of ultrasonic waveguide 6 and oscillating head 10.
  • the frequency values ⁇ corresponding to the natural frequencies are preferably determined empirically beforehand and stored in a memory of the ultrasonic wave generator 12, which is not shown in greater detail.
  • the frequency ⁇ is in an ultrasonic waveguide 6 with a length of 1.6 m and a diameter in the range of 1.6 mm at the ends and 0.7 mm in the middle thereof in the range of eg 28 kHz.
  • the ultrasonic transducer 12a is not acted upon by the ultrasonic frequency generator 12b with a signal having a single fixed frequency ⁇ , but the ultrasonic frequency generator 12b supplies the ultrasonic transducer 12a with a series of electrical pulses whose frequency is within a range from 0.5% to 5% of the value of the associated natural frequency.
  • the ultrasonic transducer 12a can be repeatedly supplied with a train of pulses for a duration of, for example, 0.1 s, starting at 50 kHz each at 28.0 kHz-650 kHz is increased and ends at 28.0 kHz + 650 Hz.
  • the desired mechanical natural frequency ⁇ of, for example, 28.0 kHz is reliably excited even when the natural frequency of the ultrasonic waveguide 6 constantly changes as a result of a mechanical deformation thereof during the processing of the thrombus 2.
  • the ultrasonic waveguide 6 may be surrounded in the region of its second end 8b by an elastic plastic tube or a plastic sleeve 16 which, on the one hand, directly contacts the ultrasonic waveguide 6 in the region outside the oscillating head 10 prevented, and is sucked through which through a suction device not shown in detail in the drawing from the vibrating head 10 shredded thrombus material from the vein or the blood vessel 4.
  • the oscillating head 10 has a club-like shape, which is preferably rounded off in the region of the region assigned to the thrombus 2, in order, in particular, during insertion of the oscillating head 10 into the vein or blood vessel 4, to avoid any injuries To cause the inner wall of the same.
  • the electromechanical ultrasonic transducer 12a of a first frequency value ⁇ which corresponds to a first natural frequency ⁇
  • the oscillating head 10 executes exclusively mechanical oscillations in the direction of the longitudinal axis 14, to act on a second frequency value cc> 2, which corresponds to a second natural frequency at which the oscillating head 10 to a transversely bending vibration is excited, ie to a vibration in a plane which is substantially perpendicular to the longitudinal axis 14.
  • the ultrasonic waveguide 6 and the oscillating head 10 is acted upon by the ultrasonic wave generator 12 with a series of ultrasonic pulses whose frequency in the manner described above in the range of 0.5% to 5 % is varied around the respective value of the natural frequency ⁇ or ⁇ 2.
  • the oscillating head By switching between a first natural frequency ol, which leads only to a longitudinal mechanical vibration of the oscillating head 10, and a second, preferably stored in a memory natural frequency cc> 2, which causes a transverse bending vibration of the oscillating head 10, the oscillating head can under To create a narrow opening first in the direction of the longitudinal axis 14 are driven into the thrombus material in order thereafter to radially expand the opening thus created in the thrombus by utilizing the bending-oscillating movement of the vibrating head 10 without damaging the surrounding tissue ,
  • the frequency of the ultrasonic wave generator 12 is always modulated in the aforementioned manner.
  • a through hole 18 located in the oscillating head 10 is preferably a through hole 18 which is inclined at an angle to the longitudinal axis 14 and which has an opening width which is slightly larger than the outer diameter of a guidewire not shown in detail.
  • the guide wire is in the case of a not completely closed thrombus 2, as shown in Fig. 1, previously drawn into the vein or the blood vessel 4, to precise guidance of the oscillating head 10 in its movement toward the thrombus 2 out and during the removal of thrombus material.
  • the passage opening 18, for example, a clear width of 0.3 to 0.5 mm.
  • a stent can be introduced via the guide wire in a known manner into the location of the vein or of the blood vessel 4, which was previously closed by the thrombus 2, in order to counteract reocclusion of the vessel at this location.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un procédé et un dispositif (1) pour éliminer les thrombus (2) dans les veines ou les vaisseaux sanguins (4) du corps humain ou animal. Ledit dispositif comporte un guide d'ondes ultrasonores (6) en forme de tige qui est pourvu, au niveau de sa première extrémité (8a), d'une tête oscillante (10) agissant sur un thrombus (2) et qui, au niveau de sa deuxième extrémité (8b), est soumis à des vibrations longitudinales mécaniques générées par un générateur d'ondes ultrasonores (12). Selon l'invention, le guide d'ondes ultrasonores (6) est réalisé dans un matériau flexible et élastique et est sollicité par le générateur d'ondes ultrasonores (12) par un train d'impulsions ultrasonores dont la fréquence varie dans une plage allant de 0,5 % à 5 % par rapport à la valeur de la fréquence mécanique propre respective du guide d'ondes ultrasonores (6) et de la tête oscillante (10).
PCT/EP2011/002744 2010-06-16 2011-06-03 Dispositif et procédé pour éliminer les thrombus WO2011157362A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102010023910.0 2010-06-16
DE201010023910 DE102010023910A1 (de) 2010-06-16 2010-06-16 Vorrichtung und Verfahren zur Entfernung von Thromben

Publications (1)

Publication Number Publication Date
WO2011157362A1 true WO2011157362A1 (fr) 2011-12-22

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2011/002744 WO2011157362A1 (fr) 2010-06-16 2011-06-03 Dispositif et procédé pour éliminer les thrombus

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DE (1) DE102010023910A1 (fr)
WO (1) WO2011157362A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013084227A1 (fr) * 2011-12-04 2013-06-13 Asymmetric Medical Ltd. Dispositif et procédés de traitement de lésions

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4750488A (en) * 1986-05-19 1988-06-14 Sonomed Technology, Inc. Vibration apparatus preferably for endoscopic ultrasonic aspirator
EP0316796A2 (fr) * 1987-11-13 1989-05-24 DON MICHAEL, T., Anthony Sonde ultrasonique pour cathéter intravasculaire pour traiter un blockage intravasculaire
WO1995009572A1 (fr) * 1993-10-04 1995-04-13 Baxter International Inc. Systeme de catheter a ultrasons possedant une sortie modulee a regulation par reaction
EP0835644A2 (fr) * 1991-01-11 1998-04-15 Baxter International Inc. Dispositif ultrasonique d'angioplastie comprenant un élément de transmission et une sonde d'ablation
DE10146011A1 (de) 2001-09-19 2003-04-03 Klaus Zimmermann Verfahren und Anordnung zur Thrombektomie
WO2003039381A1 (fr) * 2001-10-11 2003-05-15 Omnisonics Medical Technologies, Inc. Sonde echographique a desadaptation d'impedance, equipee d'un systeme de montage/demontage rapide
EP2177169A1 (fr) * 2008-10-16 2010-04-21 Lain Electronic S.r.L. Dispositif vibrant pour le traitement de tissu adipeux

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4750488A (en) * 1986-05-19 1988-06-14 Sonomed Technology, Inc. Vibration apparatus preferably for endoscopic ultrasonic aspirator
EP0316796A2 (fr) * 1987-11-13 1989-05-24 DON MICHAEL, T., Anthony Sonde ultrasonique pour cathéter intravasculaire pour traiter un blockage intravasculaire
EP0835644A2 (fr) * 1991-01-11 1998-04-15 Baxter International Inc. Dispositif ultrasonique d'angioplastie comprenant un élément de transmission et une sonde d'ablation
WO1995009572A1 (fr) * 1993-10-04 1995-04-13 Baxter International Inc. Systeme de catheter a ultrasons possedant une sortie modulee a regulation par reaction
DE10146011A1 (de) 2001-09-19 2003-04-03 Klaus Zimmermann Verfahren und Anordnung zur Thrombektomie
WO2003039381A1 (fr) * 2001-10-11 2003-05-15 Omnisonics Medical Technologies, Inc. Sonde echographique a desadaptation d'impedance, equipee d'un systeme de montage/demontage rapide
EP2177169A1 (fr) * 2008-10-16 2010-04-21 Lain Electronic S.r.L. Dispositif vibrant pour le traitement de tissu adipeux

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013084227A1 (fr) * 2011-12-04 2013-06-13 Asymmetric Medical Ltd. Dispositif et procédés de traitement de lésions

Also Published As

Publication number Publication date
DE102010023910A1 (de) 2011-12-22

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