Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N7/00—Ultrasound therapy
  • A61N7/02—Localised ultrasound hyperthermia
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
  • A61B2017/00238—Type of minimally invasive operation
  • A61B2017/00274—Prostate operation, e.g. prostatectomy, turp, bhp treatment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
  • A61B2018/00547—Prostate
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N7/00—Ultrasound therapy
  • A61N7/02—Localised ultrasound hyperthermia
  • A61N7/022—Localised ultrasound hyperthermia intracavitary

Definitions

• the present invention relates to an ultrasound location and treatment apparatus. It applies in particular to the treatment by focused ultrasound of myomas or of the other types of tumors presenting a pedicle. It also applies to the identification and treatment of blood vessels.
• Myomas are balls of muscle tissue attached to the uterus, in other words, are special fibroids. There are 3 types depending on their location:
• Myomectomy by laparotomy or laparoscopy has the disadvantage that the scar on the uterine wall remains fragile. Intervention by hysteroscopy poses the problem of limiting the operating time due to bleeding and the absorption of glycocol. This procedure therefore only applies to small myomas, i. e. from 3 to 4 mm. In addition, this procedure requires great operational skill, and can be dangerous.
• Myomas are visible on ultrasound, abdominal or transvaginal.
• transvaginal ultrasound the probe is placed along the axis of the vagina, perpendicular to the major axis of the uterus.
• abdominal ultrasound the probe is placed on the patient's abdomen.
• the hystero-ultrasound technique is advantageously used to locate the myoma. A little serum is instilled to loosen the two loops of the uterus, typically using a 2 mm catheter inserted vaginally. This technique is not painful due to the low pressure required to detach the curls from the uterus.
• mode B ultrasound The vascular supply around the fibroid which is irrigated by its periphery from a pedicle.
• ultrasound treatment and ultrasound localization probes have been proposed for the treatment of benign prostatic hyperplasia.
• These probes are suitable for treatment of the prostate, but do not have the geometric and ultrasonic characteristics used to treat myomas.
• these probes include ultrasound transducers used in mode A or in mode B.
• WO-A-93 17646 proposes an apparatus for treating the prostate by ultrasound; the device has an external therapy transducer.
• For imaging it is proposed on the one hand to use a rectal probe, and on the other hand to have an imaging probe in the center of the transducer. Again, nothing in this document suggests the treatment of myomas or pedicle tumors.
• US-A-5 882 302 describes an apparatus for the treatment of hemostasis.
• This device is designed to stop internal traumatic bleeding by focused ultrasound.
• the device is in the form of a probe capable of being inserted into a cavity, such as the vagina, the esophase, etc .; it has a transducer element, which is associated with an imaging probe; this uses Doppler imaging to produce an image of the area to be treated, and in particular of the blood flow. Doppler imagery can also be used to provide information about the areas being treated.
• Doppler imagery can also be used to provide information about the areas being treated.
• Nothing in this document suggests the treatment of myomas, or tumors by necrosis of the pedicle.
• this document does not indicate how the probe can be positioned using Doppler imaging.
• EP-A-0 734 742 describes an external ultrasound therapy apparatus, formed of an electronically focused therapy transducer, with an imaging probe. In one embodiment, it is proposed to use two-dimensional Doppler imaging. This document also does not suggest the treatment of myomas or tumors with a pedicle. No explanation is given as to the positioning of the probe.
• the invention allows the treatment of myomas, with all these advantages. It applies more particularly to the treatment of myomas located inside the uterine cavity but also to those located in the uterine wall or on the other side of it relative to the probe as far as they can be reached by the probe according to the invention, according to the focal length of the ultrasonic transducer used.
• the invention also enables simplified identification and treatment of blood vessels
• the invention provides an ultrasound location and treatment apparatus, comprising at least one therapy transducer and at least one imaging transducer, and a pulse generator exciting the therapy transducer and exciting the transducer.
• Doppler ultrasound imaging It is particularly advantageous if the imaging transducer is fixed in the center of the therapy transducer.
• Doppler ultrasound can be used to locate the area to be treated, to position the therapy transducer, before or during therapy; it can also be used to signal the end of treatment.
• the pulse generator excites the pulsed Doppler ultrasound imaging transducer.
• the therapy transducer is carried by a probe, preferably a vaginal probe.
• the therapy transducer is preferably placed at the end of the probe, to allow the treatment of uterine tissue.
• the therapy transducer has a focal length suitable for the treatment of uterine myomas when the probe is introduced into the vagina of a patient.
• the imaging transducer is disposed on the probe. In this case, the imaging transducer and the therapy transducer may be confused.
• the apparatus has a second probe, preferably an external one, on which the imaging transducer is disposed. It is then possible to provide means for measuring the relative position of the probe carrying the therapy transducer and the probe carrying the imaging transducer.
• the invention also provides a method for positioning the therapy transducer of such an apparatus for the subsequent treatment of a pedicle tumor or a myoma, comprising a step of maximizing the Doppler signal from the imaging transducer.
• - Figure 1 a schematic representation of a probe according to the invention, in the treatment position;
• - Figure 2 a diagram explaining the principle of the pulsed emission Doppler flowmeter.
• the invention is described below in its application to the treatment of myomas; the device therefore includes a probe allowing access to myomas by the vaginal route.
• the invention is however not limited to this type of apparatus, and could be used for external treatment, in which case the therapy transducers are not necessarily carried by a probe, but can be placed on a sphere, or on a support to ensure geometric or electronic focusing.
• the invention proposes to use, for the treatment of myomas, focused ultrasound, emitted by a vaginal probe.
• the invention proposes to use Doppler ultrasound for the location of the area to be treated.
• an apparatus according to the invention allows the treatment of myomas, by vaginal route, for example with the following operating modes:
• the small necrotic myomas are expelled spontaneously.
• this operation is easier: it does not cause bleeding, and the mass to be removed is reduced; it is therefore possible, even for large myomas, to consider intervention by hysteroscopy.
• the invention also proposes to use Doppler ultrasound for the identification of myomas before or during treatment, and preferably Doppler ultrasound pulsed described with reference to Figure 2. We thus arrive at a simple and precise identification of myomas.
• FIG. 1 shows a schematic representation of a probe according to the invention, in the treatment position for a myoma.
• the probe 1 is a vaginal probe, which is introduced into the patient's vagina, so that the end of the probe is near the cervix 2.
• the longitudinal axis of the probe in the treatment position shown in the figure is substantially perpendicular to the major axis of the uterus, shown in the figure by the dashed line 3.
• Reference 4 designates a myoma to be treated, on the uterine wall.
• the probe has near its end a treatment transducer or therapy transducer 5, which emits ultrasound in a direction substantially perpendicular to the longitudinal axis of the probe.
• This transducer can be mounted fixed or movable in the body of the probe, depending in particular on the method of tracking chosen, and on the need to allow passage to an imaging transducer.
• the transducer is mobile in the probe so as to allow scanning of the region to be treated, without the probe moving. This solution avoids movements of the area to be treated caused by movements of the probe due to scanning.
• the transducer could also be mounted non-perpendicular, and for example at approximately 45 ° from the axis, in a configuration similar to that used for imaging transducers in so-called "vaginal" ultrasound probes.
• an intrauterine anchoring device Such a device is known per se.
• the device is advantageously fixed to the end of the probe to avoid any movement of the latter once it is in the treatment position.
• the therapy transducer may have a shape ensuring geometric focusing of the ultrasound, as shown in the figure; it is also possible to provide electronic focusing, with a plane or non-spherical transducer.
• a therapy transducer is understood to mean not only a transducer formed from a single ceramic of geometric shape adapted to focus the ultrasound, but also a transducer formed from a set of ceramics excited independently of each other to allow electronic focusing. .
• the probe is connected to a pulse generator 7 which makes it possible to excite the therapy transducer.
• the generator delivers to the ceramic or ceramics which constitute the transducer electrical pulses of adjustable length and intensity, so as to apply via the therapy transducer therapy ultrasound.
• Ultrasound therapy means ultrasound having an intentional destructive effect or tissue necrosis, by heating or by cavitation. Such therapy ultrasound typically has an energy density greater than 1000 W / cm ⁇ .
• the device also has an imaging transducer, and a pulse generator making it possible to excite this transducer to locate the area to be treated and guide the shots.
• the pulse generator for the imaging transducer and for the therapy transducer do not provide pulses at the same powers; they can nevertheless be grouped in the same enclosure, and they will hereinafter be designated by the single expression "the pulse generator.
• the imaging transducer operates in Doppler ultrasound pulsed, and provides not only an indication of direction, but also of distance.
• the imaging transducer may be a single unit transducer, or may include multiple elements or ceramics, such as the therapy transducer.
• the imaging transducer can be integrated with the transvaginal probe in a similar arrangement to that used in the devices of the prior art mentioned above.
• the imaging transducer can make it possible to visualize the area to be treated, with or without relative movement of the imaging transducer relative to the therapy transducer.
• the imaging transducer can be attached to the center of the therapy transducer, as shown in reference 8 in the figure. Provision may be made for the therapy transducer to move apart to allow the imaging transducer to move to the localization position. You can also move the imaging transducer for imaging, and remove it for therapy. If the imaging transducer and the therapy transducer are fixed relative to each other, it is advantageous that they have the same focal point.
• the imaging transducer is independent of the therapy probe, and for example that the imaging transducer is included in a conventional ultrasound probe.
• the localization of myomas can be done by transabdominal ultrasound, over a distance of 7 to 8 cm after crossing the bladder.
• the relative movements of the imaging and therapy probes can be coordinated to allow the focal point of the therapy transducer to be brought into the desired position.
• One solution for coordinating the movements consists in mounting the probes on supports whose movement is measurable, for example an articulated arm whose movements are coded as in application EP-A-0 247 916; in this case, it is possible to introduce the therapy probe, then to acquire the relative position of the two probes, for example by pointing a given point of the therapy probe on the image provided by the probe imagery. It is enough, after this acquisition, to follow the movements of the therapy and imaging probes to know and of the imaging device.
• a single transducer is used for the treatment and for the identification of the blood vessels in pulsed Doppler mode
• the vessels can for example form part of the pedicle of the myoma
• only part of the transducer can be used for location tracking
• the advantage of this configuration is the space saving resulting from the absence of an additional image ⁇ e transducer
• the equipment can be simplified since it does not include mechanical scanning This is indeed mutile , when it comes to treating blood vessels, the diameter of which is generally of the order of magnitude of the focal zone of the firing transducer On p could have fired at the same place.
• the external probe can be used for location prior to ultrasound imaging, advantageously using the color Doppler mode if the practitioner wishes to treat the vessels, or the pedicle of 'a myoma; the vaginal probe is then introduced and manipulated by the operator so that the focal point of the transducer coincides with the pedicle
• This positioning can be done using the imaging transducer provided on the probe, which allows visualization of the myoma pedicle or myoma itself; indeed, the ultrasound in pulsed Doppler mode is directive and makes it possible to measure the distance, as explained with reference to FIG. 2
• the first or the second embodiment to use a therapy probe without scanning
• the operation of the device of the first embodiment of the invention is as follows
• the operator introduces the probe into the patient's vagina, and uses the imaging transducer to visualize the area to be treated, and position the delivery probe. so as to bring the focal spot of the therapy transducer in the vicinity of the area to be treated It is clearly advantageous in this case to use an imaging transducer operating in Doppler ultrasound, to also allow a measurement of distance.
• the image probe is moved if necessary to then proceed to therapy treatment. Between two treatment stages, you can view the treated area and check the effects of the treatment.
• the operation of the apparatus of the invention is as follows
• the operator places the therapy probe in the vagina of the patient to be treated, so that the therapy transducer would be substantially in the firing position In such a position, the transducer can be 2 or 3 centimeters from the area to be treated
• the operator locates the area to be treated, for example by ultrasound in B mode, or by Doppler ultrasound in pulsed mode, as stated above the operator fixes the relative position of the image transducer and the probe , as explained above After identification, the area to be treated is delimited, and treatment can begin.
• the therapy transducer emits power ultrasound towards the area to be treated, if necessary with a scanning of the area.
• the effect of ultrasound is to bring the area to be treated to a high temperature, typically to a temperature above 45 °, in as short a time as possible.
• the treatment can be carried out for myomas by coagulating the mass, for example by carrying out a timed scan of the area to be treated by the focal spot of the therapy transducer.
• We can also coagulate the pedicle, that is to say the blood vessels which compose it and which supply the fibroid. In this case the tissue mass will necrotize by ischemia.
• This coagulation of the vessels of the pedicle can be obtained as indicated in the article by Delon-Martin C. and others referenced above.
• Other treatment protocols for the pedicle can also be used.
• the coagulation of the vessels can be direct, by heating these vessels and the blood they contain. In this case the ultrasonic intensity is of relatively modest value, for example of the order of 1000 W / cm 2 .
• Coagulation of the vessels can also be indirect, the ultrasound being emitted at a high intensity, typically greater than 10,000 W / cm 2 , so that the walls of the vessels are damaged, thereby causing embolism.
• This treatment method applies not only to myomas, but also to other types of tumors with a pedicle or which are supplied by localized blood vessels.
• the 3rd embodiment of the invention is particularly advantageous for the destruction of blood vessels, such as those contained in the pedicle that form the basis of certain tumors, such as bladder or rectal polyps, or certain uterine myoma.
• the doctor proceeds as follows: he introduces the probe near the vessel to be destroyed, he places the probe in pulsed Doppler emission - reception mode and observes the signal.
• the imaging transducer can be used to check the effect of the application of ultrasound, and especially for guiding shots; it is advantageous to check the position of the area to be treated between each shot.
• automatic monitoring of the area to be treated can be provided by the therapy transducer, on the basis of the information provided by the imaging transducer.
• Pulsed emission doppler There is shown in the figure a transducer acting as a transceiver, a blood vessel with the measurement volume Vm, and, at the bottom of the figure, the ultrasound transmitted and received on the transducer.
• Doppler effect devices make it possible to detect the blood flows which are located opposite the ultrasound probe. We are used to distinguishing between Doppler flowmeters with continuous emission and Doppler flowmeters with pulsed emission. The first allow to know that, with regard to the probe there is or there is no blood flow but do not allow to locate at what depth is the blood flow. On the other hand, the second make it possible to determine not only the existence, but also the distance of a blood flow relative to the probe.
• the transducer periodically emits an ultrasonic wave train of duration ⁇ e ; this duration is typically of the order of a few periods, for example ten periods.
• Ultrasound is emitted at a frequency of 1 to 20 MHz depending on the depth of exploration. The greater the depth, the lower the frequency chosen. In the case of the treatment of myomas according to the invention, a frequency of 3 to 5 MHz is appropriate.
• the ultrasound is reflected by the various interfaces located in the direction of propagation of the ultrasound, and in particular by the walls of the vessel. They are also reflected by moving particles, with a different frequency due to the movement of the particles; the difference in frequency is called the "Doppler effect" and is used to determine the speed of the particles.
• the reflected ultrasound is collected by the same transducer which then plays the role of receiving transducer.
• the time separating the emission and reception of the different echoes is a function of the distance between the transducer and the target which caused the reflection.
• the study of the received signal makes it possible to determine the speed in a determined volume and to know point by point the speed of the targets located along the axis zz 'of propagation of the ultrasound.
• the echoes of the walls have been represented, as well as the echoes coming from the moving targets (here essentially the red blood cells)
• the ultrasounds returned for example by the particles located in the measurement volume Vm are received on the receiver at the end of the duration ⁇ d .
• the size of the volume to be explored is defined by the duration ⁇ r during which the reflected signals are analyzed.
• the duration setting ⁇ d makes it possible to determine the distance to the target
• the duration setting ⁇ r makes it possible to determine the volume of the target.
• another transmission train is sent. Given the distance-frequency ambiguity, the repetition period is of the order of a few kHz to 20 kHz.
• ⁇ e the duration of a pulse train
• T R the duration between two pulse trains.
• the analysis of the signal makes it possible to identify the walls of the myoma or of the pedicle of the myoma.
• the duration ⁇ d and the duration ⁇ r can then be adjusted to measure the speed of the blood in the pedicle.
• the tissues to be treated are simply and efficiently located, and the focal spot of the therapy transducer can be brought to the area to be destroyed.
• the imaging transducer can verify the existence of blood flow after treatment. When the coagulation is complete, the Doppler signal is non-existent.
• Pulsed-type Doppler effect devices and devices resulting therefrom namely duplex systems and color Doppler imagers, are described in the publication "Doppler velocimetry Application in animal and clinical cardiovascular pharmacology” by Peronneau. INSERM editions.
• the treatment carried out using the invention can therefore comprise the following stages: placement or rough positioning of the therapy transducer, for example introduction of an intracavitary probe into a cavity of the patient; identification of the area to be treated by Doppler ultrasound, and in particular by pulsed Doppler ultrasound; positioning the therapy transducer for treatment; focused ultrasound treatment, with or without scanning.
• the positioning of the therapy transducer can be carried out by maximizing the Doppler signal received. We thus manage to precisely move the focal point of the therapy transducer on the pedicle of the myoma or tumor.
• the Doppler ultrasound is performed using an additional imaging transducer or using the therapy transducer itself, which in this case constitutes an imaging transducer.
• the imaging transducer can be on the same support as the therapy transducer, or on a separate support.
• a step of measuring or calculating the relative position of the transducers is preferably provided.
• the treatment protocol of the invention can include alternating cycles of localization and treatment; it is also possible to provide an adjustment of the treatment parameters as described in the patent application filed by the applicant on 05/13/98 under the number 98,06044, and entitled "Method for measuring the effect of a treatment on a fabric”.
• the device according to the invention can be advantageously used for the coagulation of blood vessels by focused ultrasound.
• the invention also applies to all types of tumors which are nourished by a pedicle, for example vesical or digestive polyps.
• a pedicle for example vesical or digestive polyps.
• the invention also allows effective treatment of the tumor, by necrosis of the vessels which supply it.
• the Doppler signal can also be used to control the cessation of treatment, when the blood circulation in the pedicle reaches a threshold. This threshold can be predefined, or can depend on the initial blood circulation in the pedicle.
• the invention presents a therapy transducer, an imaging transducer at the center of the therapy transducer and fixed relative thereto; the imaging transducer is connected to a pulse generator exciting it in Doppler mode.
• pulse generator means all of the devices which make it possible to excite the two transducers.

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• 1999
  • 1999-05-26 FR FR9906627A patent/FR2794018B1/fr not_active Expired - Lifetime
• 2000
  • 2000-05-26 WO PCT/FR2000/001440 patent/WO2000072919A1/fr not_active Ceased
  • 2000-05-26 JP JP2000621023A patent/JP2003500177A/ja active Pending
  • 2000-05-26 US US09/744,666 patent/US6676601B1/en not_active Expired - Lifetime
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