WO2014189966A1 - Cathéter endoveineux sonique - Google Patents

Cathéter endoveineux sonique Download PDF

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Publication number
WO2014189966A1
WO2014189966A1 PCT/US2014/038836 US2014038836W WO2014189966A1 WO 2014189966 A1 WO2014189966 A1 WO 2014189966A1 US 2014038836 W US2014038836 W US 2014038836W WO 2014189966 A1 WO2014189966 A1 WO 2014189966A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
cannula
functional probe
probe
endoscopic
Prior art date
Application number
PCT/US2014/038836
Other languages
English (en)
Inventor
David R. Hennings
Craig Lindsay
David J. Fullmer
Eric B. Taylor
Robert A. Weiss
Original Assignee
New Star Lasers, Inc. A California Corporation
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
Priority claimed from US13/902,680 external-priority patent/US20130261437A1/en
Application filed by New Star Lasers, Inc. A California Corporation filed Critical New Star Lasers, Inc. A California Corporation
Publication of WO2014189966A1 publication Critical patent/WO2014189966A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided

Definitions

  • This device is related to imaging of catheter devices placed inside the body for the diagnosis or treatment of internal diseases. This device is also used to reduce the perceived pain of tumescent anesthesia injections and to induce vein spasm when treating venous disease to help drain the vessel of blood.
  • Ultrasound and ultrasonic imaging has made great advances in recent years do to improved transducers, computer analysis of the return signal and the incorporation of Doppler analysis of the image.
  • US equipment is standard equipment in all hospitals and many clinics.
  • the use of ultrasound is critical for locating catheters in veins during endovascular procedures. In most cases the resolution and gain of current equipment is sufficient to see the catheter and interpret the image, although it is common to use a specially trained technician to operate the device because it does require training and skill that few doctors have.
  • the Doppler mode on these ultrasound machines is typically used to show movement of blood in veins or arteries.
  • the Doppler frequency shift of sound that reflects of moving objects is displayed with a color on the ultrasound image that shows tissue or blood movement. The intensity and duration of this movement can be used to diagnose reflux in leg veins that are caused by incompetent valves and result in varicose veins.
  • Doppler is also used to image blood flowing in the heart to show efficiency and functionality of heart valves.
  • the target structure is very deep in tissue as when imaging veins in the thigh, it can be very hard to resolve the structure.
  • imaging the end of the catheter is considered to be one of the most difficult parts of an endovenous procedure such as varicose vein treatment.
  • the catheter is not imaged properly it is possible to treat the wrong section of the vein or even the wrong vein causing severe complications or even death. There is a great need to improve the ability to see inside the body. It would be advantageous to enhance the visibility of the location of catheters.
  • Pain management is a big part of the practice of many doctors, especially since more procedures are being done under local anesthesia in the doctor's office instead of in the hospital under general anesthesia. With the patient awake, the practice of certain procedures requires different techniques to prevent the patient from perceiving pain. It has been known that it is possible to distract patients from pain sensations and to stimulate nerves with a secondary sensation that blocks the transmission of a pain. Dentists commonly do this by pinching the cheek prior to injecting anesthesia and the vibrations from a motorized liposuction probe can mask the sensations of a needle penetrating the skin. The prior art fails to teach a way to do this inside the body in previously inaccessible locations by transmitting the distracting vibrations down a catheter or probe to the internal treatment site.
  • the acoustic density of glass or metal is close enough to that of blood or tissue that a piece of glass is very hard to image. In many cases introducing air into the tip of the catheter is not feasible. Air to tissue has a very large difference in acoustic density so that an air tissue interface reflects sound very well. Many prior art devices use air to enhance imaging.
  • the present invention improves the imaging of the position of devices inside the body.
  • the present invention uses an auxiliary sonic generator to transmit a relatively low frequency acoustic energy at typically 100 to 1000 Hz into the body.
  • the present invention also transmits the energy using transverse mechanical waves and not longitudinal sound waves as all prior ultrasound techniques have utilized.
  • the present invention may not allow precise imaging of fine details on the internal device. It may only create a reflecting surface that is moving rapidly enough to be detected under a Doppler imaging device.
  • the main advantage of the present system is to generate a locating signal that has a very high signal to noise ratio. The movement potentially blurs out the fine details that are less than the amplitude of the oscillation.
  • the present invention is a method to enhance visibility of a catheter device during an endovascular treatment. The method includes the steps of vibrating a catheter device, cannula or probe and ultrasonically imaging the catheter device, a cannula, or probe.
  • the step of vibrating the catheter device, cannula or probe includes providing a rotational, translational or longitudinal movement thereto.
  • the catheter, cannula or probe is vibrated at a frequency of between about 10 Hz and about 3000 Hz.
  • the catheter, cannula or probe is vibrated at a frequency of between about 100 Hz and about 1000 Hz.
  • the catheter, cannula or probe is vibrated at a frequency of about 500 Hz.
  • the vibration frequency and intensity of vibration is adjusted and optimized for maximum visibility using Doppler capability of an ultrasound-imaging machine.
  • the method of sonic endovenous catheter of the present invention further includes the step of coupling the vibrating device catheter or probe outside the body such that the vibrations are transmitted along the catheter into the body.
  • the vibrating device is built into the catheter or probe and the vibrating is initiated from within the body.
  • the method of sonic endovenous catheter of the present invention further includes the step of removably coupling the catheter to be vibrated to a hand-piece that incorporates the vibrator.
  • the present invention is also a method for inducing vein spasm.
  • the method includes the step of vibrating a device inside a vein.
  • the present invention is also a method for forcing blood out of a vein during endovascular treatment.
  • the method includes the steps of vibrating a catheter or probe inside a vein and inducing vein spasm, such that the vein spasm temporarily reduces the diameter of the vein.
  • the present invention is also a method for reducing pain.
  • the method includes the step of vibrating a catheter, a cannula or other functional probe endoscopically placed inside a vein.
  • the method of sonic endovenous catheter of the present invention further includes the step of timing the vibrations to distract the patient and overwhelm the nerves in the area of treatment to reduce the sensation of pain in the area of treatment.
  • the method of sonic endovenous catheter of the present invention further includes the step timing the vibrations are timed to distract the patient and overwhelm nerves in the area of treatment and injecting local anesthesia or tumescent anesthesia.
  • the present invention is also a method for reducing pain associated with the endoscopic insertion and/or moving of a catheter, cannula or other functional probe.
  • the method includes the step of vibrating the catheter, cannula or other functional probe placed inside a vein.
  • the present invention is also a system for enhancing an endoscopic therapeutic treatment.
  • the system includes an endoscopic catheter, cannula or other functional probe having a
  • a vibration emitter for emitting transverse wave vibrations along the catheter, cannula or other functional probe, apparatus for coupling the vibration emitter to the catheter, cannula or other functional probe, wherein transverse waves are transmitted along the length thereof.
  • the amplitude of the vibrations emitted by the vibration emitter can be selected manually.
  • the amplitude of the vibrations emitted by the vibration emitter can be pre-programmed.
  • the frequency of the vibrations emitted by the vibration emitter can be selected manually.
  • the frequency of the vibrations emitted by the vibration emitter can be pre-programmed.
  • the vibration emitter operates at a rate of between about 10 and about 3000 Hz.
  • the vibration emitter operates at a rate of between about 100 and about 1000 Hz.
  • the vibration emitter operates at a rate of about 500 Hz.
  • the vibration emitter comprises a motor selected from the group consisting of oscillating motors, rotary and other stepper motors, galvanometers, linear motors and out of balance or eccentrically weighted motors.
  • the vibration emitter transmits linear motion to the catheter, cannula or other functional probe.
  • the vibration emitter transmits rotational motion to the catheter, cannula or other functional probe.
  • the vibration emitter transmits sinusoidal motion to the catheter, cannula or other functional probe.
  • the endoscopic catheter, cannula or other functional probe comprises an optical fiber having a diameter between about 100 um and about 1000 um.
  • FIG. 1 is a representative drawing of an oscillating motorized device 100 clipped to a catheter 200 to produce rotational vibrations and transverse waves 110 in the catheter 200 according to the devices and methods of the present invention.
  • FIG. 2 is a representative drawing of the catheter 200 image on an ultrasound machine with and without vibrations 110 according to the devices and methods of the present invention.
  • FIG. 3 are a representative drawings of the end view 152 of the motorized vibrating device 100 showing the clip 150 to the catheter 200 and three possible motions that will cause the entire catheter 200 to vibrate according to the devices and methods of the present invention.
  • FIG. 4 are representative drawings showing how three vibration generators 100 can work using a rotary stepper motor, a galvanometer, a linear motor and an out of balance weight according to the devices and methods of the present invention.
  • FIG. 5 is a representative top view of one embodiment of sterile disposable clip 150
  • FIG. 1 is a representative drawing of an oscillating motorized device 100 clipped to a catheter 200 to produce rotational vibrations and transverse waves 110 in the catheter 200 according to the devices and methods of the present invention.
  • FIG. 2 is a representative drawing of the catheter 200 image on an ultrasound machine with and without vibrations or transverse waves 110 according to the devices and methods of the present invention.
  • an embodiment of the present invention requires three parts:
  • a mechanical vibrating device 100 that moves the proximal end of the catheter a sufficient distance to generate vibrations or transverse waves 110 that propagate the length of the catheter 200.
  • An ultrasound-imaging machine 300 that has a Doppler mode to view the moving catheter 200 inside the body.
  • catheter 200 can be an electrical wire assembly that is used to transmit electrical or radio frequency current. The construction can use fine wires that are flexible enough to withstand repeated vibrations without breaking. In alternative embodiments, catheter 200 can also be made of optical quartz, silica or other transparent materials. In one embodiment, catheter 200 should be thin enough to vibrate readily without causing internal bending stresses and should have protective jacket material over the silica to add strength. Many fiber optic catheters 200 used to deliver laser energy are constructed in a manner that will survive such mechanical vibrations 110.
  • the probe can also be a hollow cannula such as a long needle or tube or a rigid shaft or mechanical device such as used for obtaining biopsy samples.
  • FIG. 3a, 3b, 3c and 3d are representative drawings of the end view 152 of the motorized vibrating device 100 showing the clip 150 to the catheter 200 and three possible motions that will cause the entire catheter 200 to vibrate according to the devices and methods of the present invention.
  • FIG. 4 are representative drawings showing how three vibration generators 100 can work using a rotary stepper motor, a galvanometer, a linear motor and an out of balance weight according to the devices and methods of the present invention.
  • FIG. 5 is a representative top view of one embodiment of sterile disposable clip 150 according to the devices and methods of the present invention.
  • Sterile disposable clip 150 has a proximal end 156 which couples to the oscillating motor 100, and a distal end groove 154 which clips the distal end 152 of the sterile disposable tip 150 to the catheter 200.
  • sterile disposable clip 150 further has one or more finger grip(s) 158 for conveniently connecting sterile disposable clip 150 to oscillating motor 100.
  • a transverse wave 110 is one in which the direction of displacement at each point of the medium is parallel to the wavefront, or a wave in which the vibration is moving in a direction perpendicular as that in which the wave is traveling.
  • the medium moves at right angles to the wave direction. For example: if a wave moves along the x-axis, its oscillations are in the y-z plane. In other words, it oscillates across the 2-dimensional plane that it is traveling in. It may oscillate either vertically or horizontally, and this refers to its polarity.
  • Water waves are an example of transverse waves.
  • Electromagnetic waves are also transverse waves.
  • the mechanical vibrating device 100 can operate in several modes to generate transverse wave motion 110 in the catheter 200.
  • a rotary motion E can be used to twist the catheter 200 back and forth through about plus or minus 15 degrees.
  • a rotary motion E can be generated by a stepper motor 102 such as available from AMCI or Danaher Motion which is stepped back and forth through one step.
  • An electronic galvanometer such as available from General Scanning can be used which has a shaft that is connected to electromagnets in a coil. When alternating current is applied to the coils the shaft will oscillate through a small angle in either a driven or a resonant fashion.
  • a stepper motor 102 where an internal rotor containing permanent magnets is controlled by a set of external magnets that are switched electronically.
  • a stepper motor 102 is a cross between a DC electric motor and a solenoid.
  • a stepper motor 102 is a type of electric motor which is used when something has to be positioned very precisely or rotated by an exact angle. Simple stepper motors 102 "cog" to a limited number of positions, but proportionally controlled stepper motors can rotate extremely smoothly.
  • Computer controlled stepper motors 102 are one of the most versatile forms of positioning systems, particularly when part of a digital servo-controlled system. In a stepper motor 102, an internal rotor containing permanent magnets is controlled by a set of stationary electromagnets that are switched electronically.
  • Stepper motors 102 do not use brushes and commutators. Stepper motors 102 have a fixed number of magnetic poles that determine the number of steps per revolution. Most common stepper motors 102 have 200 full steps/revolution, meaning it takes 200 full steps to turn one revolution. Advanced stepper motor 102 controllers can utilize pulse-width modulation to perform microsteps, achieving higher position resolution and smoother operation. Some microstepping controllers can increase the step resolution from 200 steps/rev to 50,000 microsteps/rev. Stepper motors 102 are rated by the torque they produce. A unique feature of steppers is their ability to provide position holding torque while not in motion.
  • a linear motion F can be produced by a linear motor 104.
  • a linear motor 104 is essentially an electric motor that has been "unrolled” so that instead of producing a torque (rotation), it produces a linear force along its length by setting up a traveling electromagnetic field.
  • Linear motors 104 are most commonly induction motors or stepper motors. You can find a linear motor in a magnetic-levitation or maglev (Transrapid) train, where the train "flies" over the ground.
  • a up and down motion G can be produced by an out of balance arc motor 106.
  • FIG. 2 is a representative drawing of the catheter 200 image on an ultrasound machine with and without vibrations 110 according to the devices and methods of the present invention.
  • An embodiment of an imaging procedure is as follows:
  • the Ultrasound Imaging device such as made by GE, or others is placed over the section of body of interest.
  • the transducer head of the ultrasound device could be placed to image the sapheno femoral junction (SFJ).
  • the intensity of the color Doppler pattern 206 may be adjusted by changing the external vibration 110 frequency or intensity. It is advantageous to not overwhelm the image of the vein at the same time but to adjust the signal strength so that the tip of the catheter 208 and the vein are both visible at the same time.
  • a branched vessel phantom made by Advanced Medical Technologies, Select Series Branched 4 Vessel Vascular Access Phantom by Blue Phantom PN BPBVl 10, filled with water was used to simulate a vein inside the body.
  • a 600 um endovenous ablation catheter was placed in one of the vein lumens through a silicone tube to simulate vein transmission.
  • a Diasonics Spectra Plus ultrasound-imaging machine with a 5 MHZ linear array coupled with gel was used to image the catheter in the phantom. After the vein was located in the phantom under ultrasound, the catheter was inserted to the desired location. The gain on the ultrasound was reduced until the catheter was no longer visible to simulate imaging deep within the body. An oscillating motor was attached to the catheter about 24 inches from the imaging site.
  • the motor rotated through 30degrees of movement at about 500 Hz causing the catheter to vibrate in large standing waves that had about 5mm of amplitude outside the phantom.
  • the catheter moved approximately lmm in a transverse vibration. Under ultrasound with the Doppler mode, this movement was seen as a large colored area that had a distinct end point to it. After the gain of the ultrasound was reduced, it was possible to see exactly where the catheter was located. The end of the catheter signal moved in and out clearly with catheter movement from outside.
  • the catheter was "life tested" to determine the fatigue that the vibrations may impose on the catheter.
  • the catheter a 600 um quartz endovenous probe, was vibrated for an additional one hour without any signs of degradation.
  • the vibration time in vivo should be a minute or less.
  • the simulated life test was considered successful, and further testing will determine mean time before failure, usable life expectancy, etc. Tests also show that the 365 um fiber works better inside the leg than the thicker 600 um fiber.
  • the sonic handle may turn off by itself in about 1 minute. Simply press the light green button to re start it. The handle may also pause occasionally but re-start by itself.
  • the fiber clip may be reused.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

L'invention concerne un dispositif et un procédé pour améliorer la visibilité ultrasonore d'un cathéter positionné à l'intérieur du corps. Un dispositif de moteur externe fait vibrer le cathéter de manière sonique, lequel dispositif de moteur externe transmet la vibration acoustique en bas du cathéter et à l'intérieur du corps. Un transducteur ultrasonore est utilisé pour capturer directement les vibrations ultrasonores ou détecte les vibrations soniques à l'aide d'une machine ultrasonore en mode Doppler.
PCT/US2014/038836 2013-05-24 2014-05-20 Cathéter endoveineux sonique WO2014189966A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US13/902,680 US20130261437A1 (en) 2006-11-02 2013-05-24 Sonic Endovenous Catheter
US13/902,670 2013-05-24
US13/902,654 2013-05-24
US13/902,670 US20130261454A1 (en) 2006-11-02 2013-05-24 Sonic Endovenous Catheter
US13/902,680 2013-05-24
US13/902,654 US20130261436A1 (en) 2006-11-02 2013-05-24 Sonic Endovenous Catheter

Publications (1)

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WO2014189966A1 true WO2014189966A1 (fr) 2014-11-27

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PCT/US2014/038836 WO2014189966A1 (fr) 2013-05-24 2014-05-20 Cathéter endoveineux sonique

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WO (1) WO2014189966A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019066888A1 (fr) * 2017-09-29 2019-04-04 C.R. Bard, Inc. Appareil et procédé pour suivre un objet ultrasonore médical
CN114159638A (zh) * 2021-12-16 2022-03-11 武汉大学中南医院 一种解决血液净化引血不畅的自动化装置
US12121306B2 (en) 2023-05-12 2024-10-22 C.R. Bard, Inc. Apparatus and method for tracking a medical ultrasonic object

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070161945A1 (en) * 2002-08-02 2007-07-12 Flowcardia, Inc. Therapeutic ultrasound system
US20080275380A1 (en) * 2006-11-02 2008-11-06 Cooltouch Incorporated Sonic endovenous catheter
WO2012052925A1 (fr) * 2010-10-18 2012-04-26 CardioSonic Ltd. Emetteur-récepteur d'ultrasons et maîtrise d'un processus d'endommagement thermique
US20120215099A1 (en) * 2009-10-06 2012-08-23 Wallace Michael P Methods and Apparatus for Endovascular Ultrasound Delivery
US8328726B2 (en) * 2009-04-01 2012-12-11 Tomy Varghese Method and apparatus for monitoring tissue ablation

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070161945A1 (en) * 2002-08-02 2007-07-12 Flowcardia, Inc. Therapeutic ultrasound system
US20080275380A1 (en) * 2006-11-02 2008-11-06 Cooltouch Incorporated Sonic endovenous catheter
US8328726B2 (en) * 2009-04-01 2012-12-11 Tomy Varghese Method and apparatus for monitoring tissue ablation
US20120215099A1 (en) * 2009-10-06 2012-08-23 Wallace Michael P Methods and Apparatus for Endovascular Ultrasound Delivery
WO2012052925A1 (fr) * 2010-10-18 2012-04-26 CardioSonic Ltd. Emetteur-récepteur d'ultrasons et maîtrise d'un processus d'endommagement thermique

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019066888A1 (fr) * 2017-09-29 2019-04-04 C.R. Bard, Inc. Appareil et procédé pour suivre un objet ultrasonore médical
KR20200067153A (ko) * 2017-09-29 2020-06-11 씨. 알. 바드, 인크. 의료용 초음파 물체를 추적하는 장치 및 방법
CN111315300A (zh) * 2017-09-29 2020-06-19 巴德股份有限公司 用于跟踪医疗超声对象的装置和方法
KR102474278B1 (ko) 2017-09-29 2022-12-05 씨. 알. 바드, 인크. 의료용 초음파 물체를 추적하는 장치 및 방법
US11801096B2 (en) 2017-09-29 2023-10-31 C.R. Bard, Inc. Apparatus and method for tracking a medical ultrasonic object
CN114159638A (zh) * 2021-12-16 2022-03-11 武汉大学中南医院 一种解决血液净化引血不畅的自动化装置
CN114159638B (zh) * 2021-12-16 2023-10-24 武汉大学中南医院 一种解决血液净化引血不畅的自动化装置
US12121306B2 (en) 2023-05-12 2024-10-22 C.R. Bard, Inc. Apparatus and method for tracking a medical ultrasonic object

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