WO2015097251A2 - Dispositif médical vibrant pour procédures à effraction minimale - Google Patents

Dispositif médical vibrant pour procédures à effraction minimale Download PDF

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Publication number
WO2015097251A2
WO2015097251A2 PCT/EP2014/079250 EP2014079250W WO2015097251A2 WO 2015097251 A2 WO2015097251 A2 WO 2015097251A2 EP 2014079250 W EP2014079250 W EP 2014079250W WO 2015097251 A2 WO2015097251 A2 WO 2015097251A2
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Prior art keywords
medical device
optical
anyone
piezoelectric material
waves
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PCT/EP2014/079250
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English (en)
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WO2015097251A3 (fr
Inventor
Eric Chevalier
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Eric Chevalier
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Publication of WO2015097251A3 publication Critical patent/WO2015097251A3/fr

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    • 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
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/26—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
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    • A61C1/02—Dental machines for boring or cutting ; General features of dental machines or apparatus, e.g. hand-piece design characterised by the drive of the dental tools
    • A61C1/07—Dental machines for boring or cutting ; General features of dental machines or apparatus, e.g. hand-piece design characterised by the drive of the dental tools with vibratory drive, e.g. ultrasonic
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Definitions

  • the present invention relates to a method and device for minimally invasive procedures, and more specifically, it relates to the diagnosis, or cleaning, or removal of blockages in tubular tissues and organs.
  • the present invention relates to the ablation treatment in tubular tissues and organs.
  • the endodontic treatment comprises the steps of opening the carious cavity, cutting the enamel caries, removing the coronal pulp, enlarging the root canal orifice, exploring the root canal, extracting the radicular pulp, enlarging the root canal, and filling the root canal.
  • probe instruments will be employed to perform this treatment method, including cleansers, reamers, files, and filling tools.
  • Atherosclerosis is an intimal lesion that effects large and medium sized muscular arteries (such as coronary, iliac and femoral) and also large elastic arteries (such as aorta). It is a gradual chronic cardiovascular disease and is the most common cause of acute myocardial.
  • CTOs chronic total occlusions
  • One such approach involves the use of low frequency (20- 45 kHz) high power therapeutic ultrasonic energy delivered via small diameter wire waveguides. This form of energy develops a longitudinal standing wave in the wire waveguide and can result in distal-tip displacements up to 210 ⁇ peak - peak (p-p).
  • transducer is coupled to a transmission medium that passes within the catheter and transmits vibrations to a working tip at the distal end in close proximity to the occlusion.
  • the ultrasonic catheter devices all have a common configuration in which the source of the vibrations (the transducer) is external to the catheter.
  • the vibrational energy is coupled into the proximal end of the catheter and transmitted down the length of the catheter through a wire that can transmit the sound waves.
  • the devices are not small enough to be used for treatment of stroke and are difficult to scale to smaller sizes; it is difficult to assess or control dosimetry because of the unknown and varying coupling efficiency between the ultrasound generator and the distal end of the catheter.
  • U.S. Patent No. 5,380,273 attempts to improve on the prior art devices by incorporating advanced materials into the transmission member. Placement of the ultrasonic transducer itself at the distal end of the catheter has been impractical for a number of reasons including size and power requirements.
  • a related method for removing occlusions is laser angioplasty in which laser light is directed down an optical fiber to impinge directly on the occluding material. Laser angioplasty devices have been found to cause damage or destruction of the surrounding tissues. In some cases
  • United States Patent No. 6022309 A discloses a catheter-based device for generating an ultrasound excitation in biological tissue. Pulsed laser light is guided through an optical fiber to provide the energy for producing the acoustic vibrations. The optical energy is deposited in a water-based absorbing fluid, e.g. saline, thrombolytic agent, blood or thrombus, and generates an acoustic impulse in the fluid through thermoelastic and/or thermodynamic mechanisms. By pulsing the laser at a repetition rate (which may vary from 10 Hz to 100 kHz) an ultrasonic radiation field can be established locally in the medium.
  • a repetition rate which may vary from 10 Hz to 100 kHz
  • the limitation is a localized area of acoustic vibrations: indeed the laser energy is deposited in a volume of fluid comparable to the fiber dimension.
  • a device for removing occlusion such as a catheter or guide wire that permits generating ultrasound excitation directly in contact to occlusion without loss of energy along a small size catheter and in a large area around the distal part of the device.
  • Treatment of Ablation To provide effective diagnosis or therapy, it is frequently necessary to first map the zone to be treated with accuracy. Such mapping can be performed, for example, when it is desired to selectively ablate current pathways within a heart to treat atrial fibrillation. Once the topography of the vessel or organ is mapped, either the same or a different catheter can be employed to effect treatment.
  • WO2007/01 5139 discloses a device and method for resolving a force vector (magnitude and direction) applied to the distal end of a catheter. It discloses the use of fiber optic strain elements in a catheter that maintains essentially the same profile as with catheters that do not sense touching forces and is substantially immune to electromagnetic interference.
  • United States Patent No. 8,075,498, discloses a force sensing catheter system that utilizes the deformation of fiber Bragg grating strain sensors to infer the force incident upon the tip of the catheter.
  • US2009/0287092 discloses a fiber optic touch sensing catheter that incorporates multiple temperature sensors for active compensation of the effects caused by temperature changes, including a calibration technique for reducing thermally induced errors.
  • United States Patent No. 8,1 57,789 discloses a fiber optic touch sensing catheter that utilizes an interferometric principle to detect structural deformations of a strain sensing assembly to infer forces.
  • US201 161475384 discloses an ablation catheter system configured with a compact force sensor at a distal end for detection of contact forces exerted on an end effector. The force sensor includes fiber optics
  • the optical fibers and reflecting members cooperate with the deformable structure to provide a variable gap interferometer for sensing deformation of the structural member due to contact force.
  • diagnostic and treatment apparatus such as a catheter or guide wire
  • diagnostic and treatment apparatus that permits sensing of loads applied to a distal extremity of the apparatus, but which do not substantially increase the insertion profile of the apparatus.
  • diagnostic and treatment apparatus such as a catheter and guide wire
  • a fiber optic touch mapping catheter that combines compactness, high sensitivity and relative insensitivity to temperature change, all while being relatively easy to fabricate, would be a welcome advance in the field of minimally invasive procedure.
  • Lithotripsy is a medical procedure involving the physical destruction of hardened masses like kidney stones (also known as a renal calculus)., or gallstones (also called cholelithiasis).
  • kidney stones also known as a renal calculus
  • gallstones also called cholelithiasis
  • Three technologies and associated devices are widely used: external lithotripsy with pneumatic shock wave generator, Holmium Laser and ultrasound generator. The last two technologies are minimally invasive procedures.
  • the systems require high energy input in order to use enough energy at the distal part of the probe (such as a wave guide for ultrasound and an optical fiber for Holmium Laser) to fragment the calculi or stones. It would be a welcome to generate directly at the distal part of the probe limited energy to efficiently perform lithotripsy procedures.
  • a catheter be equipped with a surface acoustic wave sensor for detecting, measuring and/or determining a three dimensional contact force vector acting upon the catheter tip and wherein it is possible to determine the tip electrode contact area in relation to the heart wall and thus calculate the tip electrode contact pressure.
  • catheter type devices define in this application any medical or dental device.
  • a catheter type device is preferably a medical or dental device with an elongated member configured to be inserted in a body, e.g. a tooth, a vein, a body channel, any body cavity.
  • a catheter type device comprises preferably one of a therapeutic catheter, a diagnostic catheter, a guidewire, an elongated and flexible probe, a needle or a dental tip or any combination of them.
  • these aims are achieved by a catheter type device according to the independent claims.
  • the energy needed for creating the acoustic waves needed for ultrasonic treatment is transferred to the desired place in the catheter type device or medical device by light or by radio waves. Therefore, the transmission losses are minimized and the acoustic waves are generated only at the desired location.
  • the energy source and the place of ultrasonic excitation is connected by an optical conductor.
  • the energy source is preferably a light source and the ultrasonic excitation means is realized by a piezoelectric material transforming at least one wavelength of the light source in mechanical movement, in particular in ultrasonic vibrations.
  • Optical conductors like fibres can be fabricated to small dimensions, yet are highly transparent and capable of delivering substantial optical power densities from the source to the delivery site with little or no attenuation. This reduces energy loss and heat development between the desired place of ultrasonic excitation and the energy source.
  • Optical fibers are also flexible enough to navigate all vessels of interest. The method may also incorporate an optical feedback
  • these airms are achieved by a catheter type device for minimally invasive procedure comprising at least one optical fiber wherein at least one area of the optical fiber is covered by at least one piezoelectric film such that a light propagating into the optical fiber is in interaction with the piezoelectric film and the piezoelectric film is then actuated and generates mechanical waves.
  • these aims are achieved by a method with the following steps: inserting at least one fiber optic with at least one coated piezoelectric material into said vasculature; actuating said piezoelectric material by light energy, generating ultrasonic radiation field by the emission from the piezoelectric material of mechanical waves; controlling said light energy such that the maximum size of a cavitation bubble is approximately the same as the fiber diameter; and pulsing said light energy at a repetition rate such that multiple cycles of this process generates an acoustic radiation field in the surrounding fluid
  • a catheter type device adapted for mapping and/or ablation comprising: a tube means adapted for passage through a vessel in a patient's body; at least one electrode distal the tubing, the electrode configured for contact with body tissue for mapping or ablation; at least one part of the tubing is coated with a piezoelectric material; and mechanical wave generation means propagating mechanical waves into or onto the piezoelectric part
  • these aims are achieved by a method, comprising: providing a pressure and/or flowrate sensing catheter type device that includes: an elongate tubular member having a proximal portion and an opposing distal portion; a flexible element coupled to the distal portion of the elongate tubular member, the flexible element having an increased flexibility compared to the elongate tubular member; at least one surface acoustic wave sensor comprising at least one piezoelectric material coated onto the flexible element, at least one surface acoustic wave emission means linked to the coated piezoelectric material, and at least one propagating surface acoustic wave area defining the sensing area; a reader sending an interrogating signal to the sensor, generating surface acoustic wave from said emission means, and receiving response from the sensor; and inserting at least a distal portion of the pressure and/or flowrate sensing catheter type device into a vessel having a stenosis;
  • a catheter type device for endodontic procedure having at least one elongated structure with a proximal part and a distal part, wherein the distal part of the structure comprises at least one piezoelectric material coated onto the distal part such that the piezoelectric material can be actuated by at least one energy source.
  • these aims are achieved by a method for root canal therapy or endodontics using a catheter type device integrating an elongated structure comprising at its distal part at least one coated piezoelectric material actuated by at least one energy source;
  • a catheter type device comprising an elongated structure have a distal part and a proximal part, wherein at least one part is coated by at least one piezoelectric material; at least one interdigital transducer is in contact with said piezoelectric material; and at least one reader communicating with the transducer such as the reader send at least one signal to the transducer which generates surface acoustic wave on the piezoelectric material.
  • these aims are achieved by a method using a tip or file for dental procedure such as root canal therapy integrating a coated piezoelectric material structure; comprising the steps of: Inserting into root canal the tip or file; Switching on the radiation which propagates into the structure such that the radiation wavelength is specific to the nature of the piezoelectric material; Actuating the piezoelectric material; Performing cleaning of the root canal or relevant step procedure for root canal therapy.
  • said optical fiber is for use in optical coherent tomography, said optical coherent tomography integrating a plurality of light sources.
  • a surface of the piezoelectric film is chemically functionalized.
  • the functionalized piezoelectric film further integrates at least one active agent for controlled release.
  • said fiber optic is located within a catheter, said device further comprising injecting through said catheter into liquid ambient medium a thrombolytic drug to emulsify occlusion.
  • the magnitude of the acoustic vibrations induced in the tissue is monitored and controlled through a feedback mechanism.
  • said mechanical waves generates acoustic radiation field in a liquid ambient medium for the removal of an intravascular occlusion in a blood vessel or stone as part of urology procedures.
  • a laser light is used as a signal source for producing acoustic images of structures in body tissues.
  • said light source comprises a tunable wavelength.
  • said catheter type device further comprises means for resolving a force vector from said at least one strain sensing area.
  • said catheter type device further comprises temperature compensation means.
  • said mechanical wave generation/emission means are interdigited transducers.
  • the surface acoustic wave sensor has a (surface acoustic wave) resonator type design or a delay line type design a combination of the both design.
  • the surface acoustic wave sensor is operating wirelessly.
  • the senor or the catheter type device further comprises at least one (thin) membrane. This membrane is preferably linked to the piezoelectric material.
  • At least one guiding layer is linked to the piezoelectric material and/or to the sensor.
  • the senor integrates at least one shear horizontal surface acoustic wave emission means
  • the catheter type device is suitable for endodontic procedure, wherein the structure is an optical fiber and said energy source is a radiation. Preferably this energy source is an electrical energy.
  • the catheter type device comprises at least one irrigation channel.
  • the catheter type device is connected to or comprises a handpiece.
  • the handpiece integrates the energy source
  • the catheter type device is connected to an optical coherence tomography platform.
  • the structure is integrated in a tubular element.
  • the piezoelectric material has a thickness gradient. [0061] In one embodiment, the piezoelectric material further comprising at least one dopant specie.
  • the surface acoustic wave is in contact with tissue to perform measurements.
  • the piezoelectric material is removable from the device.
  • the light has an ultraviolet wavelength.
  • the catheter type device comprises a force sensing area at a distal end for detection and mapping of contact forces.
  • the present invention provides means for in situ cleaning in endodontic treatment, or for dissolution of a vascular occlusion by generating directly ultrasonic excitation in the fluids inside the root canal, or in close proximity or, according to the case, directly inside a vascular occlusion to further its fragmentation.
  • Figure 1 shows a view of an optical fiber with a deposited piezoelectric material actuating when absorbing light guided by the fiber;
  • Figure 2 shows a representation of an Endodontic tip or file integrating a coated piezoelectric material structure
  • Fig 3 shows a schematic representation Endodontic tip with irrigation channel
  • Fig 4 shows a schematic representation endodontic tip wherein a coated piezoelectric material structure is integrating in a tubular element
  • Figure 5 shows a schematic representation of an optical coherence tomography integrating an optical fiber where a part of it is coated by a piezoelectric material actuating by lighting through the fiber;
  • Figure 6 shows a part of a catheter type device with a design integrating a surface acoustic wave technology
  • Figure 7 shows a part of a catheter type device integrating coated interdigited electrode onto a piezoelectric film deposited onto the device.
  • a delay line design comprises a plurality of reflectors
  • Figure 8 shows a part of a catheter type device integrating a plurality of Surface acoustic wave generation means
  • Figure 9 shows a view of a SAW technology embedded in a catheter type device comprising a guiding layer
  • Figure 10 shows a top view schematic representation of a Catheter type device with haptic functionality in the distal part
  • Figure 1 1 shows a schematic representation of a Catheter type device with haptic functionality when a force is applied on the distal part of the device;
  • Figure 12 shows a SAW resonator design integrated onto a catheter type device
  • Figure 13 shows a SAW Delay line Design integrated onto a catheter type device.
  • the Figure 1 shows the basic principal of one embodiment of the catheter type device.
  • the catheter type device comprises an optical conductor 1 and a material 2.
  • the material 2 is configured to transform optical waves received over the optical conductor 1 into a mechanical movement of the material 2.
  • the material 2 absorbs optical waves and transforms the absorbed energy of the optical waves in mechanical movement of the material 2.
  • An example for such a material 2 is a material configured to perform
  • the material 2 is arranged at the desired position for the mechanical movement.
  • the movement of the material 2 is a vibration, i.e. a periodic movement of the material 2.
  • it is an ultrasound vibration.
  • the periodic movement leads normally to a surface acoustic wave (SAW) on the conductor 1 .
  • the material 2 has at least one activation wavelength for which the material 2 absorbs optical waves and transforms those optical waves of the activation wavelength into the mechanical movement.
  • the activation wavelength is in the ultraviolet range, but other optical wavelengths are possible.
  • the material 2 is arranged at the distal end of the conductor 1. In one embodiment, the material 2 is coated at the circumference of the optical conductor 1 . In one embodiment, an
  • the intermediate substrate is arranged between the material 2 and the optical conductor 1 to increase bonding between the optical conductor 1 and the material 2.
  • the substrate should be configured to transfer the optical energy of the optical waves at the activation energy.
  • the material 2 is a piezoelectric material.
  • the piezoelectric material 2 may be a Zinc oxide (ZnO), or
  • AIN Aluminium nitride
  • LiNbO Lithium Niobium Oxide
  • other piezoelectric materials 2 might be possible. If the piezoelectric material is ZnO, the wavelength of the radiation is about 360nm because the ZnO absorbance is max. Other parameters such as piezoelectric material porosity or dopant concentration in the material 2 could be taken into account in order to improve the radiation absorbance and/or the material adherence onto the fiber.
  • a catheter type device integrates the piezoelectric material further comprising at least one dopant species.
  • the material 2 could be also arranged at the distal end of the optical conductor in continuation of the optical conductor. In this case, the material 2 is arranged at the distal end of the optical conductor 1 in the conducting axis of the conductor.
  • the conductor 1 forms at the distal end a contact surface, preferably in the form of the bottom of a cylinder, which contacts to the material 2.
  • the outer dimensions and/or form of a cross-section through the material 2 is (substantially) the same as those of a cross-section of the conductor 1 .
  • both cross-sections are aligned.
  • This embodiment has the advantage that the material 2 is arranged where the light exits the conductor 1 anyway and the material 2 can absorb a maximal energy from the conducted light.
  • the thickness of the material 2 influences the frequency of the created mechanical vibration. Therefore, the thickness can be used in order to define the frequency or the frequency spectrum of the created
  • the thickness of the material 2 is constant. In one embodiment, the thickness of the material 2 is constant.
  • the material 2 has a plurality of thicknesses in order to create a plurality of frequencies. This could be realized e.g. by a thickness gradient in order to create a frequency spectrum. In one embodiment, there is a plurality of materials 2 with different thicknesses for creating multiple frequency vibrations. Those different materials 2 could be made of the same substance. In an alternative embodiment, the different materials 2 could be made of different substances such that the creation of the different frequencies could be activated by different activation
  • the different materials 2 could be activated individually and independently
  • each of the different materials 2 are connected by its own optical conductor 1 .
  • the optical conductor 1 is configured to transfer the optical waves to the material 2.
  • the optical conductor 1 is configured to conduct at least one activation wavelength of the material 2.
  • the optical conductor 1 is an optical fiber. However, any other optical conductors 1 might be used.
  • the optical conductor 1 is flexible, even though the invention would also work with rigid optical conductors 1 .
  • the optical conductor 1 in the boundary surface with the material 2 allows the penetration of the optical waves, in particular of the activation wavelength.
  • the catheter type device may further show an optional optical source (not shown in Fig. 1 ).
  • the optical source is configured to create optical waves with at least one activation wavelength of the material 2. Obviously, if the material 2 has a plurality or a range of activation wavelengths, the light source could use only one, a subset or all of those activation wavelengths to activate the material 2. It is also possible that the optical source 2 is configured to create optical waves comprising
  • the optical source is arranged at the proximal end of the conductor 1 .
  • the catheter type device may not incorporate an optical source, but may show only an interface at a proximal end of the optical conductor 1 configured to be connected to a suitable optical source.
  • the catheter type device according to this embodiment has the advantage that optical waves are used to transfer energy over the optical conductor 1 to the desired position for mechanical vibrations.
  • a catheter type device could be used in many medical and dental fields.
  • the material 2 could generate locally concentrated vibrations in the fluid.
  • the local vibrations could produce collapsing cavitation bubble in the fluid which is an advantage for specific minimally invasive procedures such as intracorporeal lithotripsy.
  • the conductor 1 could inserted in the desired vessel such that the vibrations are created only in the vessel and not along the conductor 1 .
  • Figure 2 shows an embodiment of the catheter type device as described in Fig. 1 .
  • the catheter type device is an endodontic tip or file
  • the elongated member comprises the optical conductor 1 and the material 2 coated on the surface of the elongated member.
  • the elongated member could be consituted directly by the optical conductor 1 such as an optical fibre or could provide a tube structure including therein the optical conductor 1 .
  • the elongated member and thus the conductor 1 could be integrally formed with the handpiece 3' or could be attachable with the proximal end of the
  • the handpiece 3' may comprise the optical source, e.g. a LED.
  • the handpiece 3' may be provided with the optical waves by a further optical conductor.
  • Figure 3 shows a variation of the endodontic tip or file 3 of Fig. 2 further comprising an irrigation channel 4 .
  • the irrigation channel 4 is connected on one side with a reservoir for the irrigation fluid or with a connector for connecting the irrigation channel 4 to such a reservoir.
  • the irrigation channel 4 opens on the handpiece 3' in vicinity of the elongated member in order to irrigate an irrigation fluid in the root canal.
  • Such tip or file 3 can be used also for prophylaxis
  • Figure 4 shows a variation of the endodontic tip or file 3 of Fig. 2, wherein the elongated member or the conductor 1 is integrated in a tubular element 5.
  • the tubular element 5 may be formed such as a drill.
  • the advantage of this embodiment is that the practitioner can not only use the piezo functionality, thanks to said vibrations he can perform efficient cleaning into the root canal, but he can also actuate the tubular element 5 to prepare the canal for the next step of the procedure which is the filling by cement type material such as gutta percha.
  • a method using a tip or file 3 for dental procedure e.g. a root canal therapy, integrating an elongated member coated with a material 2; comprising the steps of: Inserting into root canal the elongated member or the conductor 1 (at least a part of the material 2 should be inserted in the root canal); Switching on a light radiation with at least one activation wavelength which propagates into the conductor 1 ; as a consequence, the piezoelectric material 2 starts actuating/vibrating; Performing cleaning of the root canal or relevant step procedure for root canal therapy.
  • a catheter type device according to Fig.
  • optical detector 1 comprising additionally an optical detector configured to detect optical waves captured at the distal end of the optical conductor 1 and transmitted via the conductor 1 to the optical detector.
  • An example for such an optical detector is an optical coherence tomography system as shown in Fig. 5.
  • the advantageous configuration allows on one hand the use of optical fiber for tomography and on the other hand, without changing the conductor 1 during the minimally invasive procedure, to perform vibration actuation by lighting the piezoelectric material.
  • the optical detection mode and the mechanical wave generation mode could be controlled independently by using a optical waves for the detection mode with another wavelength or other wavelengths than the activation frequencies of the material 2.
  • the detection mode could be performed without the activation of the material 2. It is also possible to perform detection and activation at the same time by inserting detection optical waves and activation optical waves at the same time in the conductor 1 . However, preferably the detection is performed in another time window than the activation in order to deteriorate the measurements in the detection mode. In another embodiment, the same optical waves are used for detection and activation. However, this has the disadvantage that the detection can only be performed at the same time with the activation. Accordingly, the same or different optical sources can be used for the detection and the activation mode. In the case the same optical source is used, the optical source may be controllable to emit optical waves with different wavelengths. Preferably, the optical source is a laser.
  • the device produces an ultrasonic radiation field in a fluid by: (i) depositing e.g. optical energy transferred by the material 2 in acoustic energy in a volume of fluid.
  • the volume of the fluid is comparable to the fiber dimension.
  • the time scale of duration of the optical wave pulse is less than the acoustic transit time across this dimension (as controlled by choice of laser wavelength and absorbing fluid as the case may be), (ii) The laser energy is controlled such that the maximum size of the cavitation bubble is approximately the same as that of the fiber diameter, (iii) The laser is pulsed at a repetition rate such that multiple cycles of this process generates an acoustic radiation field in the surrounding fluid; resonant operation may be achieved by synchronizing the laser pulse repetition rate with the cavity lifetime.
  • the bubble expansion and collapse couples acoustic energy into the fluid.
  • Subsequent laser pulses are delivered to repeat or continue this cycle and generate an ultrasonic radiation field at a frequency or frequencies determined by the laser pulse frequency. Similar to the first mode, a resonant operation may be achieved by matching the laser pulse period to the lifetime of the cavitation bubble.
  • a device where the fiber optic is located within a catheter said device further comprising injecting through said catheter into liquid ambient medium a thrombolytic drug to emulsify occlusion.
  • a catheter type device wherein said fiber optic is located within a catheter, said device further comprising injecting through said catheter into liquid ambient medium a radiographic contrast agent to facilitate visualization.
  • the energy transmission to the material 2 is replaced by a wireless radio signal.
  • Fig. 6 to 1 1 shows such
  • Fig. 6 shows a medical device, preferably a catheter type medical device, comprising a tubular element 50, a piezoelectric material 52, an interdigital transducer 53 (also called interdigited electrode) and a signal input.
  • a medical device preferably a catheter type medical device, comprising a tubular element 50, a piezoelectric material 52, an interdigital transducer 53 (also called interdigited electrode) and a signal input.
  • the tubular element 50 is preferably adapted to be inserted or implanted in body cavities, like vessels, veins and other body cavities.
  • the cross-section of the tubular element 50 is preferably circular, but can have any other form like ellipsoid, rectangular, etc.
  • the piezoelectric material 52 is preferably arranged on the curved surface area of the tubular element 50. In one embodiment, the piezoelectric material 52 is arranged on the complete circumference of the tubular element 51 (at least over a certain distance along the longitudinal axis of the tubular element 51). However, it is also possible that the piezoelectric material 52 does not cover the complete circumference.
  • the tubular element might be an optical conductor according to Fig.
  • the piezoelectric material 2 may be a Zinc oxide (ZnO), or Aluminium nitride (AIN), or a Lithium
  • Niobium Oxide LiNbO
  • other piezoelectric materials 2 might be possible.
  • the interdigital transducer 53 is arranged on the piezoelectric material 52.
  • the interdigital transducer 53 is configured to induce a surface acoustic wave based on a certain input signal.
  • the interdigital transducer 53 comprises preferably two interlocking electrodes, e.g. comb-shaped arrays of electrodes.
  • the interdigital transducer 53 is preferably arranged such that the principal direction of distribution of the surface acoustic wave is the direction of the longitudinal axis of the tubular element 51 . This could be achieved by arranging the electrode fingers of the two comb- shaped arrays along the circumferential of the tubular element 51 and rectangular to the longitudinal axis of the tubular element 51 .
  • the interdigital transducer 53 is configured to create a surface acoustic wave with at least one wavelength.
  • the wavelength could be influenced by the distance between the fingers of the two interdigital electrodes and by the dimensions, especially in direction of the longitudinal axis of the tubular element 51 .
  • the surface acoustic wavelength comprises a plurality of wavelengths.
  • the signal input is here realized as an antenna 54 which is connected to at least one electrode of the interdigital transducer 53, here to both electrodes. This allows to receive a radio signal at the antenna 54 which induces a surface acoustic wave by the interdigital transducer 53 on the piezoelectric material 52.
  • the antenna 54 could be realized as a coil. However, other signal inputs might be also possible like an electric conductor.
  • the medical device comprises a second interdigital transducer 53' and a second antenna 54'.
  • the second interdigital transducer 53' is configured to receive the surface acoustic wave transmitted by the first interdigital transducer 53, to transfer it to an electric signal and to send this electric signal back over the second antenna 54' as a feedback signal.
  • This feedback signal could have a number of functions. In one embodiment, it could be used to control the induced surface acoustic wave on the basis of the feedback signal by varying the input signal. In one embodiment, it could be used to measure a stain or deformation of the tubular element. In one embodiment, it could be used to sense qualitative or quantitative information relevant for said medical procedure.
  • a controller being part of or being external to the medical device. This allows to measure a force and/or position of a touching point, where the tubular element might touch something, e.g. a cavity, a vessel or a vein of the body.
  • the second antenna 54' could be replaced by other output means like e.g. an electric conductor.
  • the second interdigital transducer 53' is arranged like the first interdigital transducer 53 such that the principal direction for receiving surface acoustic waves is parallel to the longitudinal axis of the tubular element 51.
  • the interdigital transducer 53' is arranged so on the circumference of the tubular element 51 that the projection of the first interdigital transducer 53 in the direction of the longitudinal axis of the tubular element 51 corresponds to the second interdigital transducer 53'.
  • the interdigital transducer 53' compared to the first interdigital transducer 53 is possible.
  • the catheter type device may comprises a coated and chemically functionalized piezoelectric material 52.
  • the surface acoustic waves may act as trigger for drug release function interacting with liposomes fixed to the piezoelectric function wherein active agents are embedded into the liposomes.
  • Fig. 7 shows a further embodiment of the medical device described in Fig. 6.
  • the medical device replaces here the second transducer 53' and the second antenna 54' by at least one reflector 56, 57, 58.
  • the surface acoustic wave induced by the interdigital transducer 53 is reflected by each of the at least one reflector 56, 57 and 58.
  • the reflected signal(s) received at the interdigital transducer 53 is sent back as a feedback signal.
  • the feedback signal can have the same functions as in the first embodiment of Fig. 6. Another function would be the identification of the tubular element by the at least one delay times or their relative time differences. In this embodiment, only one of the two electrodes of the interdigital transducer 53 is connected to the antenna, while the other is connected to earth.
  • a medical device comprising a second antenna 64, a second interdigital transducer 63 and a second at least one reflector 66, 67 and 68.
  • the first interdigital transducer 53 - reflector 56, 57, 58 - arrangement might have another function than the second interdigital transducer 63 - reflector 66, 67, 68 - arrangement.
  • Each transducer could have an independent design of the other, e.g. one with a reflector 56, the other with a second interdigital transducer 53'.
  • Such a reflector could be superfluous, if the tubular element 51 provides natural reflections.
  • interdigital transducers In general a plurality of interdigital transducers might be arranged on the tubular element 51 .
  • the interdigital transducers might have each another function. They might be arranged on one or a plurality of coated piezoelectric materials or on the same coated piezoelectric materials.
  • Figure 9 shows longitudinal cross-section of the coating on the tubular element 51 of the embodiment of Fig. 6.
  • the piezoelectric material 52 is coated on a substrate 71 .
  • interdigital transducer 53' is (at least in the line of sight) the same
  • the piezoelectric material 52 such that there are no reflecting bounderies for the surface acoustic wave between the two interdigital transducers 53 and 53'.
  • the material 72 could be also different to the piezoelectric material 52.
  • the piezoelectric material 52 and/or the material 72 can be covered by a cover layer 73. In one embodiment, this layer is isolating in order to isolate the electrodes of the transducers. In one embodiment, the layer 73 has some special chemical or biological effects. In one
  • the layer is configured to slow down the velocity of the surface acoustic wave at the border surface between the piezoelectric material 52 and the layer 73.
  • the layer 73 guides the surface acoustic wave to the second transducer 53' or to a reflector 56, 57, 58.
  • the effect of the guiding layer 73 is to trap the acoustic energy near a sensing surface, reducing propagation velocity and increasing the sensitivity to surface perturbations.
  • the sensing surface could be for example the surface where a touch could be detected or quantified.
  • the sensing surface could be a chemically or biologically functionalized region, where the surface acoustic wave passes. Depending on the chemically or biologically bonded material to this functionalized region, the surface acoustic wave in this region changes. Therefore, biological or chemical measurements could be performed on the basis of the feedback signal.
  • the piezoelectric material could be covered by a layer 73.
  • the surface acoustic waves become bulk acoustic waves.
  • Figure 10 shows a figurative top view of the tip of the tubular element 51.
  • the tip of the tubular element 51 is round to be configured for continuous acoustic surface wave propagation.
  • the tip or the cylindrical side wall of the tubular element or both could comprise the first interdigital transducer 53 as described in the figures before.
  • interdigital transducers measure the surface acoustic waves in order to locate the place and/or force (amplitude and/or direction) of a touch of the tubular element in more detail.
  • the interdigital transducers could be used as sender and as receivers or there could be interdigital transducers used only for sending and ones only for receiving.
  • a haptic function of the medical device can be realized. With a plurality of interdigital transducers on the tubular element 51 , a real time mapping of acoustic wave propagation could be realized leading to the mapping of forces interacting with the piezo parts.
  • a haptic function catheter type device 1 10 for use in a medical procedure device is depicted wherein the distal part is covered/coated by at least one layer of a piezoelectric material 1 13 and at least one interdigited electrode 1 12 which generates surface acoustic waves (SAW) 1 1 1 on the piezoelectric material when energy is provided (wirelessly or not) to the electrode by an input signal.
  • SAW surface acoustic waves
  • the haptic function catheter type device further comprising means for Radiofrequency (RF) ablation procedure.
  • RF Radiofrequency
  • a method using an haptic function catheter type device for medical procedure wherein surface acoustic waves propagates on at least one piezoelectric part of the device generated by at least one interdigited electrodes actuated by an input signal; un force or a contact is applied on the piezoelectric part modifying the SAW propagation; and characterizing the output signal from the electrode to a controller; the output signal leads to quantitative information about the force such as amplitude and orientation(vector).
  • a plurality of piezoelectric parts may give quantitative information on a mapping in real time of force or contact applied to the parts.
  • the catheter type device may comprise any of a number of haptic function, such as but not limited to RF ablation electrodes, rotary or scissor action cutting heads, laser ablation, injection or sewing needles, fluid conveyance systems, forceps, manipulators, mapping electrodes, endoscopic vision systems and therapeutic delivery systems such as genetic
  • Figure 12 shows a representation of a surface acoustic wave delay line design integrated onto a catheter type device.
  • a resonator is composed of an interdigital transducer in the center of the structure and reflecting gratings or electrodes on both sides of the interdigital transducer.
  • the interdigital transducer is a bi-directional structure, it means the energy propagates on both sides at the same intensity.
  • the reflecting gratings or electrodes reflect the energy produces by the interdigital transducer.
  • a resonant cavity is obtained and characterized by its resonant frequency. Advantages: high quality factor, low insertion losses. Such an arrangement could also be used in the embodiments shown before.
  • Figure 13 shows a representation of a surface acoustic wave delay line design integrated onto a catheter type device.
  • a delay line is composed of an interdigital transducer at one side of the device and reflecting gratings or electrodes (reflector) at the other side.
  • the interdigital transducer generates an impulse wave which propagates to the electrodes.
  • the impulse wave is reflected by the electrodes or reflecting gratings to the interdigital transducer.
  • the electrodes are deposited on a piezoelectric material which is coated on the catheter type device. At least one intermediate layer of a specific material between the piezoelectric material or film and the catheter type device can be deposited to enhance the adherence of the piezoelectric layer on the catheter type device.
  • the catheter type device/medical device can be used for to generate an acoustic radiation field in a liquid ambient medium for the removal of an intravascular occlusion in a blood vessel or stone as part of urology procedures.
  • the catheter type device could be used for root canal therapy or endodontics using.
  • Such a catheter type device is often also called endodontic tip or file 3.
  • the conductor 1 or a tube containing the conductor 1 is inserted in a root canal and cleaning and/or treatment of said root canal is performed by actuating the piezoelectric material by the optical waves.
  • Applications envisioned for this invention include any method or procedure whereby localized ultrasonic excitations from a piezoelectric material deposited onto an optical fiber and actuating by a radiation are to be produced in the body's tissues through application of a probe.
  • the invention may be used in (i) endovascular treatment of vascular occlusions that lead to ischemic stroke, (ii) endovascular treatment of cerebral vasospasm (This technology can relax vaso-constriction leading to
  • the piezoelectric material 2, 52 or film 73 , deposited onto the catheter type device is chemically functionalized for improving the interaction of the device with its environment such as hemocompatibility of the device.
  • the functionalized piezoelectric film further integrating at least one active agent for controlled release of the agent into a body.
  • the piezoelectric material is removable from the catheter type device; advantageously the piezoelectric material is integrated into a chip which is placed in the catheter type device.
  • the piezoelectric material is coated on the tubular element. This has the advantage of providing a better connection of the piezoelectric material 2/52 to the tubular element 1/51 , optionally with a substrate in between than a simple chip which is than e.g. glued on the tubular element. In addition, for many applications this improves the quality of the results or makes certain function possible.
  • the piezoelectric element in a chip could not detect the changes in surface acoustic waves with the same quality as a coated piezoelectric material 52, because of the number of border surfaces the acoustic wave has to pass. Therefore, it is advantageous that this embodiment make the use of a chip superfluous.

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Abstract

L'invention concerne un dispositif du type cathéter comprenant : un conducteur optique (1) pourvu d'une extrémité proximale et d'une extrémité distale et conçu pour conduire des ondes optiques; et un matériau (2) destiné à transformer les ondes optiques conduites par le conducteur optique (1) en ondes mécaniques.
PCT/EP2014/079250 2013-12-23 2014-12-23 Dispositif médical vibrant pour procédures à effraction minimale WO2015097251A2 (fr)

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