WO2011015586A1 - Electrophysiological neurostimulating ultrasonic aspirator, particularly for removing pathological tissue in neurosurgery - Google Patents

Electrophysiological neurostimulating ultrasonic aspirator, particularly for removing pathological tissue in neurosurgery Download PDF

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Publication number
WO2011015586A1
WO2011015586A1 PCT/EP2010/061302 EP2010061302W WO2011015586A1 WO 2011015586 A1 WO2011015586 A1 WO 2011015586A1 EP 2010061302 W EP2010061302 W EP 2010061302W WO 2011015586 A1 WO2011015586 A1 WO 2011015586A1
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WO
WIPO (PCT)
Prior art keywords
aspirating
tissue
protected
cannula
aspirator
Prior art date
Application number
PCT/EP2010/061302
Other languages
French (fr)
Inventor
Marco Cenzato
Original Assignee
Marco Cenzato
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Marco Cenzato filed Critical Marco Cenzato
Publication of WO2011015586A1 publication Critical patent/WO2011015586A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0808Detecting organic movements or changes, e.g. tumours, cysts, swellings for diagnosis of the brain
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes

Definitions

  • the present invention relates to an electrophysiological neurostimulating ultrasonic aspirator, particularly for removing pathological tissue in neurosurgery.
  • Ultrasonic aspirators are currently known which are used particularly in the medical field in the surgical and neurosurgical sectors.
  • the vibration frequency of the tip is usually set so as to be absorbed by the elastic tissues that lie in the vicinity of the biological tissue to be removed, for example such as the arteries, which are thus protected.
  • aspirators are currently used in the field of neurosurgery during the removal of tumors and other pathological tissues at the level of the cranium, of the brain, of the spinal cord and of the cranial nerves.
  • known types of aspirators are not devoid of drawbacks, which include the fact that if the removal of the biological tissue to be removed occurs in extremely delicate areas, such as for example proximate to the brain areas assigned to controlling body movements or to producing speech, known types of aspirators are used with a continuous alternation with electrostimulating devices that are suitable to stimulate the nervous structures in the surgical context or in the vicinity of the biological tissue to be removed, in order to detect the position of the nervous structures with respect to the surgical field.
  • Another drawback of known types of aspirators used together with stimulation at intervals consists in that due to the alternation of the removal of pathological tissue and verification by neurostimulation, if the nervous structures to be protected are so altered by the tumors to be removed that they cannot be recognized visibly, said nervous structures risk being damaged prior to the subsequent verification.
  • the aim of the present invention is to provide an electrophysiological neurostimulating ultrasonic aspirator, particularly for removing pathological tissue in neurosurgery, that solves the drawbacks of the background art.
  • an object of the present invention is to provide an aspirator with a high degree of reliability, which allows to protect, as much as possible, the nervous tissue that lies close to the tissue to be removed against accidental removals and/or damage.
  • Another object of the present invention is to provide an aspirator that is extremely versatile and economically competitive if compared with the background art currently used to perform the same surgical and neurosurgical operations.
  • an electrophysiological neurostimulating ultrasonic aspirator particularly for removing pathological tissue in neurosurgery, comprising at least one aspirating cannula, which can be arranged proximate to a biological tissue to be removed and is functionally connected to aspirating means and to vibrating means for vibrating the tip of said at least one aspirating cannula at a preset frequency and for aspirating the cells of said biological tissue to be removed, fragmented by the vibration of said tip, characterized in that it comprises means for generating electrical pulses and means for detecting electrical responses, which are functionally connected to said at least one aspirating cannula and to the nervous tissue to be protected that lies adjacent to said biological tissue to be removed, respectively, for the electrophysiological stimulation of said nervous tissue to be protected and for detection of the neurophysiological response generated by said nervous tissue to be protected which is stimulated electrophysiologically, said at least one aspirating cannula being made of
  • the electrophysiological neurostimulating ultrasonic aspirator particularly for removing pathological tissue in neurosurgery, generally designated by the reference numeral 1, comprises at least one aspirating cannula 2, which is made of an electrically conducting material, such as for example a metallic material, and can be arranged proximate to the biological tissue 3 to be removed, which can be for example a tumor mass, particularly of the neurological type.
  • an electrically conducting material such as for example a metallic material
  • the aspirating cannula 2 is functionally associated with at least one control handpiece 4, which can be gripped by the operator and is functionally associated with vibrating means and with aspirating means, which can be arranged respectively inside the control handpiece 4 and outside the control handpiece 4.
  • the aspirating cannula 2 is functionally connected to the aspirating means by way of flexible tubes 5 and to the vibrating means by way of devices which are per se known and are therefore not described in detail.
  • the tip 6 of the aspirating cannula 2 can vibrate at a preset frequency, for example an ultrasonic frequency, which is set so as not to damage the biological tissues that are not to be removed, such as arteries and the like, and aspirates the cells of the biological tissue 3 to be removed, fragmented by the vibration of said tip 6.
  • a preset frequency for example an ultrasonic frequency, which is set so as not to damage the biological tissues that are not to be removed, such as arteries and the like, and aspirates the cells of the biological tissue 3 to be removed, fragmented by the vibration of said tip 6.
  • the aspirator 1 comprises means 7 for generating electrical pulses which are functionally connected to the aspirating cannula 2 and are suitable to stimulate the nervous tissue 13 to be protected, which is adjacent to the biological tissue 3 to be removed, and means 8 for detecting electrical responses by means of electrodes.
  • the generator means 7 have, for example, a first electrode 10, which can be connected to the patient acting as the ground, and the second electrode 9, which is connected to the aspirating cannula 2, providing a neurophysiological stimulation of the monopolar type.
  • the detection means 8 can comprise two or more electrodes 11 and 12, which can be connected to a plurality of muscle groups which are innervated by the nervous tissue 13 to be protected.
  • the electrodes 11 and 12 can comprise a pair of electrodes that can be connected to the muscles that close the eyelid and a pair of electrodes that can be connected to the muscles of the mouth; whereas if one is working proximately to the nervous fibers that control the movement of the body, up to four pairs of electrodes to be connected to the muscles of the arms and legs may be necessary.
  • the electrical pulse generated by the generator means 7 is controlled by the operator by way of means for controlling the intensity, duration and waveform of the electrical stimulus carried to the tip 6 and functionally associated with the generator means 7.
  • Operation of the electrophysiological neurostimulating ultrasonic aspirator 1, particularly for removing pathological tissue in neurosurgery, particularly for removing tumor masses and the like, is as follows.
  • the tip 6 of the aspirating cannula 2 is arranged proximate to the tumor mass to be removed or, more generically, to the biological tissue 3 to be removed.
  • the tip 6 fragments the cells of the biological tissue 3 to be removed, which are aspirated within the aspirating cannula 2 and then removed from the surgical field.
  • the electrical stimulation is carried to the tip 6 of the aspirating cannula 2 and maintains a constant neurophysiological stimulation during removal of the biological tissue 3 to be removed.
  • the nervous tissue 13 to be protected which for example can be a nerve or one or more brain structures, any lesions of the nervous tissue 13 to be protected can be easily avoided.
  • the aspirator 1 can be used:
  • the electrophysiological neurostimulating ultrasonic aspirator particularly for removing pathological tissue in neurosurgery, according to the present invention, fully achieves the intended aim and objects, since it allows to remove pathological tissue continuously while reducing significantly the times of the operation and protecting neighboring tissues from any lesions during the neurosurgical operation.
  • Another advantage of the aspirator according to the present invention consists in that it has distinctly higher safety margins than the background art constituted by continuous detection, instead of at intervals, performed therefore during the removal of the tumor mass itself, of the distance between the tip of the aspirating cannula and the nervous tissues to be protected.
  • a further advantage of the aspirator according to the present invention consists in that it is possible to extend, in view of the higher safety margins ensured by the continuous feedback provided by neurostimulation, the surgical indications for pathological lesions that today are considered unfeasible due to the high risk of postoperative neurological lesions.
  • Another advantage of the aspirator according to the present invention consists in that it is extremely versatile and economically competitive, if compared with the background art currently used to perform the same surgical and neurosurgical operations, since it provides for the use of a single device instead of two distinct devices.
  • the materials used may be any according to requirements and to the state of the art.

Abstract

An electrophysiological neurostimulating ultrasonic aspirator (1), particularly for removing pathological tissue in neurosurgery, comprising at least one aspirating cannula (2), which can be arranged proximate to a biological tissue (3) to be removed and is functionally connected to aspirating means and to vibrating means for vibrating the tip (6) of said at least one aspirating cannula (2) at a preset frequency and for aspirating the cells of the biological tissue (3) to be removed, fragmented by the vibration of the tip (6), the aspirator further comprising means (7) for generating electrical pulses and means (8) for detecting electrical responses, which are functionally connected to the aspirating cannula (2) and to the nervous tissue (13) to be protected that lies adjacent to the biological tissue (3) to be removed, respectively, for the electrophysiological stimulation of the nervous tissue (13) to be protected and for detection of the neurophysiological response generated by the nervous tissue (13) to be protected which is electrophysiologically stimulated.

Description

ELECTROPHYSIOLOGICAL NEUROSTIMULATING ULTRASONIC ASPIRATOR, PARTICULARLY FOR REMOVING PATHOLOGICAL TISSUE IN NEUROSURGERY
Technical field
The present invention relates to an electrophysiological neurostimulating ultrasonic aspirator, particularly for removing pathological tissue in neurosurgery.
Background art
Ultrasonic aspirators are currently known which are used particularly in the medical field in the surgical and neurosurgical sectors.
These known types of devices comprise an aspirating cannula, the tip of which vibrates with an ultrasonic frequency so as to act as a small hammer that fragments the cells of the biological tissue to be removed, which are simultaneously aspirated by said aspirating cannula, removing them from the surgical field.
The vibration frequency of the tip is usually set so as to be absorbed by the elastic tissues that lie in the vicinity of the biological tissue to be removed, for example such as the arteries, which are thus protected.
By using these known types of aspirators it is therefore possible to remove progressively biological tissues such as tumors and other pathological tissues, sparing the arteries inside or proximate to the tumor.
In particular, these known types of aspirators are currently used in the field of neurosurgery during the removal of tumors and other pathological tissues at the level of the cranium, of the brain, of the spinal cord and of the cranial nerves.
However, known types of aspirators are not devoid of drawbacks, which include the fact that if the removal of the biological tissue to be removed occurs in extremely delicate areas, such as for example proximate to the brain areas assigned to controlling body movements or to producing speech, known types of aspirators are used with a continuous alternation with electrostimulating devices that are suitable to stimulate the nervous structures in the surgical context or in the vicinity of the biological tissue to be removed, in order to detect the position of the nervous structures with respect to the surgical field.
In fact the electrical stimulation of nerves and areas of the nervous system during neurosurgical procedures is used to identify said nervous structures to be preserved during the removal of the biological tissue to be removed.
This way of proceeding leads to prolonged surgical times needed in order to perform the neurosurgical operation.
Another drawback of known types of aspirators used together with stimulation at intervals consists in that due to the alternation of the removal of pathological tissue and verification by neurostimulation, if the nervous structures to be protected are so altered by the tumors to be removed that they cannot be recognized visibly, said nervous structures risk being damaged prior to the subsequent verification.
Disclosure of the invention
The aim of the present invention is to provide an electrophysiological neurostimulating ultrasonic aspirator, particularly for removing pathological tissue in neurosurgery, that solves the drawbacks of the background art.
Within this aim, an object of the present invention is to provide an aspirator with a high degree of reliability, which allows to protect, as much as possible, the nervous tissue that lies close to the tissue to be removed against accidental removals and/or damage.
Another object of the present invention is to provide an aspirator that is extremely versatile and economically competitive if compared with the background art currently used to perform the same surgical and neurosurgical operations.
This aim, as well as these and other objects that will become better apparent hereinafter, are achieved by an electrophysiological neurostimulating ultrasonic aspirator, particularly for removing pathological tissue in neurosurgery, comprising at least one aspirating cannula, which can be arranged proximate to a biological tissue to be removed and is functionally connected to aspirating means and to vibrating means for vibrating the tip of said at least one aspirating cannula at a preset frequency and for aspirating the cells of said biological tissue to be removed, fragmented by the vibration of said tip, characterized in that it comprises means for generating electrical pulses and means for detecting electrical responses, which are functionally connected to said at least one aspirating cannula and to the nervous tissue to be protected that lies adjacent to said biological tissue to be removed, respectively, for the electrophysiological stimulation of said nervous tissue to be protected and for detection of the neurophysiological response generated by said nervous tissue to be protected which is stimulated electrophysiologically, said at least one aspirating cannula being made of an electrically conducting material.
Brief description of the drawings
Further characteristics and advantages of the present invention will become apparent from the description of a preferred but not exclusive embodiment of an electrophysiological neurostimulating ultrasonic aspirator, particularly for removing pathological tissue in neurosurgery, according to the invention, illustrated by way of non-limiting example in the accompanying drawing, wherein the sole figure is a schematic view of the aspirator according to the invention.
Ways of carrying out the invention
With reference to the figure, the electrophysiological neurostimulating ultrasonic aspirator, particularly for removing pathological tissue in neurosurgery, generally designated by the reference numeral 1, comprises at least one aspirating cannula 2, which is made of an electrically conducting material, such as for example a metallic material, and can be arranged proximate to the biological tissue 3 to be removed, which can be for example a tumor mass, particularly of the neurological type.
More particularly, the aspirating cannula 2 is functionally associated with at least one control handpiece 4, which can be gripped by the operator and is functionally associated with vibrating means and with aspirating means, which can be arranged respectively inside the control handpiece 4 and outside the control handpiece 4.
The aspirating cannula 2 is functionally connected to the aspirating means by way of flexible tubes 5 and to the vibrating means by way of devices which are per se known and are therefore not described in detail.
In this manner, the tip 6 of the aspirating cannula 2 can vibrate at a preset frequency, for example an ultrasonic frequency, which is set so as not to damage the biological tissues that are not to be removed, such as arteries and the like, and aspirates the cells of the biological tissue 3 to be removed, fragmented by the vibration of said tip 6.
According to the invention, the aspirator 1 comprises means 7 for generating electrical pulses which are functionally connected to the aspirating cannula 2 and are suitable to stimulate the nervous tissue 13 to be protected, which is adjacent to the biological tissue 3 to be removed, and means 8 for detecting electrical responses by means of electrodes.
More precisely, the generator means 7 have, for example, a first electrode 10, which can be connected to the patient acting as the ground, and the second electrode 9, which is connected to the aspirating cannula 2, providing a neurophysiological stimulation of the monopolar type.
As regards the detection means 8, they can comprise two or more electrodes 11 and 12, which can be connected to a plurality of muscle groups which are innervated by the nervous tissue 13 to be protected.
For example, if the facial nerve is to be protected, the electrodes 11 and 12 can comprise a pair of electrodes that can be connected to the muscles that close the eyelid and a pair of electrodes that can be connected to the muscles of the mouth; whereas if one is working proximately to the nervous fibers that control the movement of the body, up to four pairs of electrodes to be connected to the muscles of the arms and legs may be necessary.
In this manner it is possible to stimulate electrophysiological^ the nervous tissue 13 to be protected and it is possible to detect the neurophysiological response generated by the nervous tissue 13 to be protected which is stimulated electrophysiologically.
Advantageously, the electrical pulse generated by the generator means 7 is controlled by the operator by way of means for controlling the intensity, duration and waveform of the electrical stimulus carried to the tip 6 and functionally associated with the generator means 7.
Operation of the electrophysiological neurostimulating ultrasonic aspirator 1, particularly for removing pathological tissue in neurosurgery, particularly for removing tumor masses and the like, is as follows.
The tip 6 of the aspirating cannula 2 is arranged proximate to the tumor mass to be removed or, more generically, to the biological tissue 3 to be removed.
By operating both the aspirating means and the vibrating means, the tip 6 fragments the cells of the biological tissue 3 to be removed, which are aspirated within the aspirating cannula 2 and then removed from the surgical field.
Concurrently, by way of the electrical conductivity of the aspirating cannula 2, the electrical stimulation is carried to the tip 6 of the aspirating cannula 2 and maintains a constant neurophysiological stimulation during removal of the biological tissue 3 to be removed.
In this manner it is possible to have continuous detection of the neurophysiological response of the nervous tissue 13 to be protected, which, being reproduced graphically or otherwise, for example acoustically, can be easily monitored by the operator.
Since this neurophysiological response is closely correlated to the distance of the tip 6 of the aspirating cannula 2 with respect to the nervous tissue 13 to be protected, which for example can be a nerve or one or more brain structures, any lesions of the nervous tissue 13 to be protected can be easily avoided.
Advantageously, the aspirator 1 can be used:
- in neurosurgery of tumors or other pathological tissue of cranial nerves,
- in neurosurgery of deep encephalic tumors, such as for example in the case of deep tumors that reach the vicinity of functionally relevant nervous fibers
- in the removal of pathological tissue proximate to extremely delicate brain areas, such as for example proximate to the brain areas assigned to controlling body movements or the production of speech, which are known in the technical jargon as "eloquent",
- in the removal of pathological tissue in the brain stem
- in the removal of tumors of the spinal cord, where it is fundamental to protect the healthy part of the cord,
- in view of the possibility of certain tips of the ultrasonic aspirator to fragment and remove bone tissue, in the removal of bone regions of the cranial base, inside which cranial nerves pass,
- whenever it is necessary to remove pathological tissue while functionally protecting relevant contiguous nervous tissue, such as for example in the surgery of spinal dysraphism.
In practice it has been found that the electrophysiological neurostimulating ultrasonic aspirator, particularly for removing pathological tissue in neurosurgery, according to the present invention, fully achieves the intended aim and objects, since it allows to remove pathological tissue continuously while reducing significantly the times of the operation and protecting neighboring tissues from any lesions during the neurosurgical operation. Another advantage of the aspirator according to the present invention consists in that it has distinctly higher safety margins than the background art constituted by continuous detection, instead of at intervals, performed therefore during the removal of the tumor mass itself, of the distance between the tip of the aspirating cannula and the nervous tissues to be protected.
A further advantage of the aspirator according to the present invention consists in that it is possible to extend, in view of the higher safety margins ensured by the continuous feedback provided by neurostimulation, the surgical indications for pathological lesions that today are considered unfeasible due to the high risk of postoperative neurological lesions.
Another advantage of the aspirator according to the present invention consists in that it is extremely versatile and economically competitive, if compared with the background art currently used to perform the same surgical and neurosurgical operations, since it provides for the use of a single device instead of two distinct devices.
The electrophysiological neurostimulating ultrasonic aspirator, particularly for removing pathological tissue in neurosurgery, thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the appended claims.
All the details may further be replaced with other technically equivalent elements.
In practice, the materials used, as long as they are compatible with the specific use, as well as the contingent shapes and dimensions, may be any according to requirements and to the state of the art.
The disclosures in Italian Patent Application No. MI2009A001442 from which this application claims priority are incorporated herein by reference.
Where technical features mentioned in any claim are followed by reference signs, those reference signs have been included for the sole purpose of increasing the intelligibility of the claims and accordingly, such reference signs do not have any limiting effect on the interpretation of each element identified by way of example by such reference signs.

Claims

1. An aspirator, particularly for removing pathological tissue in neurosurgery, comprising at least one aspirating cannula (2), which can be arranged proximate to a biological tissue (3) to be removed and is functionally connected to aspirating means and to vibrating means for vibrating the tip (6) of said at least one aspirating cannula (2) at a preset frequency and for aspirating the cells of said biological tissue (3) to be removed, fragmented by the vibration of said tip (6), characterized in that it comprises means (7) for generating electrical pulses and means (8) for detecting electrical responses, which are functionally connected to said at least one aspirating cannula (2) and to the nervous tissue (13) to be protected that lies adjacent to said biological tissue (3) to be removed, respectively, for the electrophysiological stimulation of said nervous tissue (13) to be protected and for detection of the neurophysiological response generated by said nervous tissue (13) to be protected which is stimulated electrophysiologically, said at least one aspirating cannula (2) being made of an electrically conducting material.
2. The aspirator according to claim 1, characterized in that said preset frequency is ultrasonic.
3. The aspirator according to claim 1, characterized in that said at least one aspirating cannula (2) is made of a metallic material.
4. The aspirator according to claim 1, characterized in that it comprises means for controlling the intensity, duration and waveform of the electrical stimulus carried on said tip (6) and functionally associated with said generator means (7).
5. The aspirator according to one or more of the preceding claims, characterized in that it comprises at least one control handpiece (4), which can be gripped by the operator and is functionally associated with said at least one aspirating cannula (2), with said vibrating means and with said aspirating means.
PCT/EP2010/061302 2009-08-07 2010-08-03 Electrophysiological neurostimulating ultrasonic aspirator, particularly for removing pathological tissue in neurosurgery WO2011015586A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI2009A001442 2009-08-07
IT001442A ITMI20091442A1 (en) 2009-08-07 2009-08-07 ULTRASONIC VACUUM DEVICE ELECTROPHYSIOLOGICAL NEUROSTIMULATOR, PARTICULARLY FOR THE REMOVAL OF PATHOLOGICAL FABRIC IN NEURO SURGICAL AREA.

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WO2011015586A1 true WO2011015586A1 (en) 2011-02-10

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WO2013154876A1 (en) * 2012-04-09 2013-10-17 Ethicon Endo-Surgery, Inc. Surgical instrument with nerve detection feature

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