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WO2005058411A1 - Necessaire s'utilisant comme dispositif de stimulation des nerfs - Google Patents

Necessaire s'utilisant comme dispositif de stimulation des nerfs Download PDF

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Publication number
WO2005058411A1
WO2005058411A1 PCT/JP2004/017774 JP2004017774W WO2005058411A1 WO 2005058411 A1 WO2005058411 A1 WO 2005058411A1 JP 2004017774 W JP2004017774 W JP 2004017774W WO 2005058411 A1 WO2005058411 A1 WO 2005058411A1
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WO
WIPO (PCT)
Prior art keywords
nerve
guide tube
puncture needle
stimulating
electrode
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2004/017774
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English (en)
Japanese (ja)
Inventor
Osamu Ukimura
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kansai Technology Licensing Organization Co Ltd
Original Assignee
Kansai Technology Licensing Organization Co Ltd
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 Kansai Technology Licensing Organization Co Ltd filed Critical Kansai Technology Licensing Organization Co Ltd
Publication of WO2005058411A1 publication Critical patent/WO2005058411A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0507—Electrodes for the digestive system
    • A61N1/0512—Anal electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control

Definitions

  • the present invention relates to a kit of a device for stimulating a nerve (also referred to as a "nerve stimulating device") (that is, a set of members constituting such a device), for example, a device for stimulating an erectile nerve (or erectile nerve stimulation).
  • a nerve also referred to as a "nerve stimulating device”
  • a device for stimulating an erectile nerve or erectile nerve stimulation.
  • Device erectile nerve stimulation kits.
  • Such devices are used to electrically stimulate nerves running near a part of the body (eg the prostate) when operating on that part. Then, by monitoring the response of the nerve in response to the stimulus, the location of the nerve is specified, and as a result, it is possible to perform an operation without damaging the specified location when the nerve runs. .
  • Erectile dysfunction associated with surgery for prostate cancer is caused by the erectile nerve, which is a form of multiple fine erectile nerve fibers, being damaged by a scalpel or the like during surgery.
  • erectile nerve which is a form of multiple fine erectile nerve fibers, being damaged by a scalpel or the like during surgery.
  • Non-Patent Document 1 Although the size of the electrode is too large, it can be proved that the nerve should be present somewhere near the tip of the electrode, However, there was a problem that they did not have the ability to accurately identify
  • Patent Document 1 JP-A-2000-140132
  • Non-Patent Document 1 Laurence KLOTZ and Sender HERSCHORN, UROLOGY 52, pp 537-542, 1998
  • the problem to be solved by the present invention is to improve the identification of the location of a nerve running near the location to be treated in various medical procedures, for example, laparoscopic surgery. It is to provide means that can be implemented with high accuracy. In particular, it provides a means of identifying a nerve while avoiding damage to that nerve.
  • the electrical stimulation of the erectile nerve in the existing laparotomy is performed by arranging an electrode above a place where the nerve is expected to be present.
  • This stimulus is a stimulus that is applied in the immediate vicinity of the surgical site and that is applied to the external force (ie, from the outer surface of the membrane surrounding the neurovascular bundle), and consequently the running of the erectile nerve.
  • This stimulates a point relatively far from the point.
  • the erectile nerve is located inside the sheath of the neurovascular bundle, such electrical stimulation can be said to be indirect.
  • the nerve is a bundle of fine fibers, and it is difficult for the naked eye to distinguish it from other lymphatic vessels and thin blood vessels (similarly, bundles of fine fibers).
  • the method of stimulating the nerve in this way and specifying the running position of the nerve is as follows.
  • the specific accuracy is insufficient, and the inventor has examined this point.
  • the accuracy is insufficient because the thin film is interposed between the electrode and the nerve.
  • the place where the nerve is predicted to be running is visually observed from the outside, and based on it, it is only determined, and the presence of the nerve is not directly visible. It was decided that it was something to do.
  • an image forming apparatus is used to stimulate the erectile nerve with electrodes in prostate cancer surgery, particularly in laparoscopic surgery. Identify the location of the neurovascular bundle containing the erectile nerve, insert the tip of the electrode into the neurovascular bundle, preferably in direct contact with the erectile nerve, and then apply a current to the electrode to stimulate the erectile nerve. This led to the conclusion that the running location of the erectile nerve could be identified with high accuracy. This conclusion applies not only to the specific case of the erectile nerve running location, but also to the specific case of other nerve running locations.
  • the present invention provides a kit for a nerve stimulation device that can be suitably used for specifying a site where a medical treatment is to be performed, for example, a nerve running site near a surgical site.
  • a kit for a nerve stimulation device of the present invention includes a guide tube, a puncture needle inserted into the guide tube, and a stimulation electrode (or a nerve stimulation electrode) inserted into the guide tube.
  • these members can be slidably (or slidably) inserted into the guide tube upon insertion.
  • a site to be subjected to medical treatment refers to a medical treatment or diagnosis.
  • Means the part of the body that undergoes treatment (surgery, radiation therapy, high temperature therapy, laser therapy, tissue biopsy, nerve block, etc.).
  • the nerve stimulation device of the present invention is configured using the kit of the nerve stimulation device of the present invention.
  • This device is composed of a puncture needle inserted into a guide tube, and a stimulation electrode inserted into the guide tube instead of the puncture needle.
  • the puncture needle inserted into the guide tube is used first, and then the stimulating electrode inserted into the guide tube is used instead of the puncture needle.
  • the puncture needle is placed inside the body with the puncture needle inserted into the guide tube, and then the puncture needle is pulled out of the guide tube with the guide tube left inside, and the stimulation electrode is used instead of the puncture needle.
  • the guide tube is composed of a puncture needle inserted into a guide tube, and a stimulation electrode inserted into the guide tube instead of the puncture needle.
  • the above-described arrangement of the guide tube into which the puncture needle is inserted in the body is performed by inserting the guide tube into which the puncture needle is inserted into the body.
  • Such insertion may be insertion into the body cavity at the first stage, but as described later, the distal end of the puncture needle ultimately forms an incision at a predetermined position in the human body. In this sense, “insertion” can be said to be “puncture (or puncture)”.
  • the distal tip portion of the guide tube, the puncture needle and the stimulation electrode protrudes from the distal end of the guide tube.
  • the distal tip of the puncture needle protrudes from the distal end of the guide tube and is positioned in close proximity to, or in direct contact with, the nerve to be stimulated.
  • the distal end of the stimulation electrode when protruding from the distal end of the guide tube.
  • the projection amount is substantially the same as the projection amount at which the puncture needle also projects the guide tube force.
  • the distal tip portion of the stimulation electrode preferably has a blunt end surface so as not to damage the nerve.
  • the end surface may be a curved surface such as a hemisphere, a dome, or the like.
  • the nerve stimulation device of the present invention preferably has additional means so that a current can flow through the stimulation electrode.
  • the nerve stimulation device has a current supply device, and the stimulation electrode is configured to be connectable to the current supply device.
  • the current supply device supplies a predetermined current to the stimulation electrode.
  • the nerve stimulation data of the present invention is used.
  • the vise is inserted into the guide tube with the distal end of the puncture needle inserted into the guide tube based on an image obtained by the image forming apparatus which is particularly preferable to be used in combination with the image forming apparatus. Or pierce and proceed.
  • the tip of the stimulation electrode can be moved in the body (usually slightly) based on the image obtained by the image forming apparatus, instead of the puncture needle.
  • the present invention provides a nerve stimulation system, which includes the nerve stimulation device and the image forming apparatus of the present invention, and preferably supplies a predetermined current to the stimulation electrode. It further comprises a supply device.
  • the present invention provides a guide tube, a puncture needle, and a stimulating electrode, which constitute a kit of the nerve stimulation device according to the first aspect.
  • the present invention provides, in the third aspect, the use of the image forming apparatus, the current supply apparatus, and the above-described nerve stimulation device of the present invention or the kit thereof, that is, the use of the nerve stimulation system of the present invention. To provide a way to stimulate the nerves.
  • the nerve stimulation method of the present invention uses the above-described nerve stimulation device or its kit,
  • the nerve stimulation method when a predetermined current is applied to provide electrical stimulation to a nerve running immediately or in the vicinity of the distal tip portion of the stimulation electrode, the nerve is stimulated.
  • Characteristic response caused by the stimulation of When it is remarkably recognized, it can be understood that the nerve is running immediately or near the distal tip portion of the stimulation electrode, that is, the running position of the nerve can be specified.
  • the nerve stimulation method of the present invention is a nerve running place confirmation method. For example, when electrical stimulation is applied to the erectile nerve, the response is the sponge pressure.
  • ⁇ muscles '' can be broadly divided into two types: ⁇ smooth muscles '' existing in the internal organs and ⁇ skeletal muscles '' existing in the limbs and the face. It measures mainly the change in intraluminal pressure due to contraction of the smooth muscle in the internal organs, and if the target is skeletal muscle, the movement itself is directly observed with the eyes.
  • the distal end of the stimulation electrode is used.
  • the nerve is not running immediately near or near the part.
  • An experienced physician can generally set the target location empirically to a location that is not too far from the nerve running spot, so that the nerve runs at a location that is not too far from the distal tip of the stimulation electrode.
  • the possibility of changing the position of the distal tip of the transstimulation electrode is small. In the case of such a slight displacement, the stimulation electrode may be moved by applying a small force.
  • the stimulating electrode may be inserted into the guide tube instead of the puncture needle, and a current may be supplied to stimulate the nerve.
  • step 4 a predetermined current is supplied to the stimulation electrode, and the response to the current of the nerve that may be running immediately near or near the distal tip portion of the stimulation electrode is observed, If there is no response or the response is insufficient, the tip of the stimulation electrode is moved to another location and the current is supplied again, and finally the nerve is displaced to a location where there is a nerve response and the nerve runs. Identify the location. That is, in step 4), a predetermined current is supplied to the stimulation electrode, and the response to the current of the nerve that may be running immediately near or near the distal tip portion of the stimulation electrode is observed, and the nerve is monitored. Identify the driving location.
  • the above-described nerve stimulation method is used in performing various medical treatments (or treatments, for example, laparoscopic surgery) to confirm a traveling position of a nerve, and to perform a medical treatment based on the confirmation.
  • This is effective for preventing damage to nerves located at the running location. That is, the nerve can be preserved by confirming the location where the nerve runs and performing medical treatment so as to avoid the location.
  • the present invention provides a medical treatment (or treatment) method for preserving nerves, in which a nerve running place is confirmed using the above-described nerve running place confirmation method of the present invention, and the place is identified. Implement medical procedures (or treatments) so as to avoid them, in particular, avoiding any parts that could damage the nerves running in the area near the area I do.
  • the distal end portion of the puncture needle can be reliably placed at the intended target location.
  • the puncture needle thus reached is replaced with a stimulating electrode, and a current is supplied to observe the nerve response. It can be confirmed that the vehicle has reached the nearest point of travel. That is, the stimulation electrode extends to the inside of the sheath-like thin film surrounding the neurovascular bundle.
  • the distal end portion of the stimulation electrode can be located at an appropriate site in the neurovascular bundle, that is, at or near a target nerve running point such as erectile nerve. Therefore, in the vicinity of the tip of the stimulating electrode, which is located so that the nerve can be stimulated by supplying an electric current, it is component that the nerve is running. Great care can be taken in performing the procedure to avoid damaging the nerves.
  • the present invention provides a device that enables a surgeon to reliably recognize the location of the erectile nerve during surgery for the purpose of preventing postoperative erectile dysfunction in this prostate cancer operation.
  • FIG. 1 is a schematic perspective view of each element constituting a kit of a nerve stimulation device of the present invention
  • FIG. 1 (a) shows a guide tube
  • FIG. 1 (b) shows a puncture needle
  • Figure 1 (c) shows the stimulation electrode.
  • FIG. 2 is a schematic cross-sectional view of a nerve stimulating device of the present invention in a state where a puncture needle is inserted and an electrode is inserted.
  • FIG. 2 (a) shows a distal end portion of the puncture needle inserted into a guide tube.
  • FIG. 2B shows another embodiment of the distal tip of the stimulation electrode inserted into the guide tube, and
  • FIG. 2C shows another embodiment of the distal tip of the stimulation electrode inserted into the guide tube.
  • FIG. 3 shows a schematic diagram of an ultrasonic probe that can be used with the nerve stimulation device of the present invention.
  • FIG. 3 (a) is a perspective view of only the probe, and FIG. 3 (b) is equipped with a guide tube into which a puncture needle is inserted.
  • Fig. 3 (c) shows the appearance of the probe as viewed obliquely from above, and
  • Fig. 3 (b) shows the appearance of Fig. 3 (b) viewed from above.
  • FIG. 4 is a diagram schematically showing how the device of the present invention is used rectally. Explanation of symbols
  • reference numbers indicate the following elements: 10 ⁇ Guide tube, 12 ⁇ Puncture needle, 14 ⁇ Stimulation electrode, 16, 18 ⁇ Grip element, 20 ⁇ Tip, 24 ⁇ Conductor element, 26 ⁇ Insulation material, 28 Tip tip, 30 Grip element, 32 Proximal end of stimulation electrode, 33 Stimulation current supply device, 34 Ultrasonic probe, 36 Ultrasonic wave Irradiation part, 37 ⁇ ⁇ ⁇ through-hole, 38 ⁇ ⁇ ⁇ opening at the distal end, 39 ⁇ ⁇ ⁇ opening at the proximal end, 40 ⁇ ⁇ ⁇ ultrasound probe, 42 ... rectum, 44 ... prostate, 50 ... Proximal end, 52, 54 ... distal end, 58 ... lead wire, 60 ... irregularities.
  • the present invention includes In the case of surgery or other medical treatment of a site, the same can be used for stimulating nerves running near the site to specify the running site.
  • the guide tube has a structure in which the puncture needle can be inserted into the inside of the guide tube so that the distal end portion of the puncture needle projects.
  • the distal end of the puncture needle protrudes from the distal end of the guide tube, and when a neurovascular bundle including the erectile nerve, more specifically, the erectile nerve runs in or near the prostate.
  • Extracorporeal forces are also inserted into the body at the expected location (also called the “target location”).
  • the distal end of the puncture needle forms an incision in a predetermined part of the human body and enters the body, and in that sense, “insertion” means “puncture (puncture). Or piercing) ".
  • the first stage of insertion may be into a body cavity (eg, the rectum) without making an incision.
  • a body cavity eg, the rectum
  • the insertion of the guide tube is stopped and maintained.
  • Such insertion or puncture (or puncture) at the target site may be performed in any suitable manner.
  • distal refers to a person who operates the device when there are two corresponding locations (for example, the distal end portion). ! Used to indicate the location located on (or near) side.
  • the puncture needle has a structure such that when inserted into the guide tube, the distal tip portion can be in a state of protruding from the distal end portion of the guide tube.
  • the distal end of the puncture needle protruding from the distal end has a sharp end face, and is used for the neurovascular bundle running on the side of the prostate.
  • An incision can be made in the thin film.
  • the distal end of the puncture needle can enter the inside of the neurovascular bundle through the incision, so that the distal end of the distal end of the puncture needle can be located in close proximity to the erectile nerve. Can directly contact the erectile nerve.
  • the access path to the erectile nerve or its vicinity is secured by the tip of the puncture needle penetrating into the neurovascular bundle.
  • the stimulation electrode has a structure that can be inserted into a guide tube instead of a puncture needle, and a distal end portion thereof can protrude from the distal end of the guide tube as in the case of a puncture needle.
  • the puncture needle is removed while leaving the guide tube in the body as it is, and then stimulated into the guide tube maintained in that state.
  • the distal end of the distal end portion of the stimulation electrode projects from the distal end portion of the guide tube to reach the erectile nerve or its vicinity. In such a state, a current is supplied to the stimulation electrode and a current is supplied to the erectile nerve to stimulate the erectile nerve.
  • the kit for a nerve stimulation device of the present invention can constitute a nerve stimulation device including a guide tube, a puncture needle, and a stimulating electrode force.
  • the device has a puncture needle inserted into the guide tube.
  • the nerve can be stimulated by combining the inserted state of the puncture needle and the inserted state of the electrode for stimulation in the guide tube. Therefore, the present invention is configured using a guide tube, a puncture needle, and a stimulation electrode, and includes a puncture needle insertion state in which a puncture needle is inserted in the guide tube, and an electrode insertion state in which a stimulus electrode is inserted in the guide tube.
  • a configurable neural stimulation device is provided.
  • the target location and the target location are set by the image forming apparatus.
  • the target tube and the guide tube are visually inspected by visually observing the state of the guide tube which advances by force, particularly the distal end portion of the puncture needle protruding from the distal end of the guide tube. U, it is preferable to grasp the positional relationship with the puncture needle and bring the tip of the puncture needle closer to the target location.
  • Such insertion of the guide tube may be performed by any suitable method, but the former, which is preferably performed transrectally or transperineally, is particularly preferred.
  • the target portion is a neurovascular bundle including the erectile nerve, and the tip of the tip of the puncture needle approaches the neurovascular bundle. Or, after reaching, it is preferably a place where the erectile nerve is predicted to run. For example, at the time of puncture, such a location is predicted from the positional relationship between the blood vessel and the most advanced part (inside, outside, ventral, dorsal, etc. of the blood vessel) that can be confirmed by the image forming apparatus in the neurovascular bundle. You can do it.
  • the image forming apparatus used in combination with the nerve stimulation device of the present invention may be an image forming apparatus that is used in various treatments and diagnoses in the medical field, and that has an appropriate deviation.
  • an ultrasonic tomography apparatus a Doppler ultrasonic tomography apparatus, a three-dimensional image construction ultrasonic diagnostic apparatus, a radiographic imaging apparatus, and a computer-controlled tomography apparatus (so-called CT) can be exemplified.
  • CT computer-controlled tomography apparatus
  • an apparatus that forms an image using ultrasonic waves can be exemplified.
  • the nerve stimulating device of the present invention in combination with an image forming apparatus using an ultrasonic probe transluminally (e.g., rectally). While grasping the relationship between the target location and the tip of the puncture needle in the image displayed on the display, the guide tube with the distal end of the puncture needle protrudingly inserted or inserted into the target location.
  • an ultrasonic probe transluminally e.g., rectally
  • An image forming apparatus using such an ultrasonic probe may be used, for example, for prostate examination, diagnosis, surgery, and the like. Specific examples thereof include known ones used in transrectal ultrasonic transection, transrectal ultrasonic guided prostate biopsy, and the like. In particular, it is preferable to use an imaging technique for obtaining blood flow ultrasonic information using a ultrasonic Doppler method transrectally to draw a blood vessel.
  • Such an image forming apparatus currently used can specify a traveling position of a blood vessel, but cannot specify a traveling position of a fine V or nerve such as an erectile nerve.
  • the nerve stimulating device of the present invention is effective for specifying the location of a nerve such as the erectile nerve in detail.
  • the opening at the distal end of the through-hole provided at an angle to the longitudinal direction of the probe is located inside the rectum, and the opening at the proximal end is located outside the body.
  • the probe may be inserted into the rectum, and the insertion may be performed by inserting the guide tube into the through hole at the opening at the proximal end so that the opening at the distal end projects.
  • the protruding tip of the puncture needle is further advanced along with the guide tube to the rectal wall. Insert the guide tube and push the guide tube toward the target site, i.e., insert the guide tube transrectally, then puncture and finally target the distal end of the tip of the puncture needle. Reach the point.
  • an ultrasonic probe that can be fitted with a biopsy needle or a No Opti Opti gun is used. Attach the guide tube with the tip of the puncture needle protruding from the distal end of the guide tube to the probe, and insert and puncture the guide tube in the same manner as for biopsy sampling.
  • Probes that can be used in this way include those that can apply a biopsy needle to the prostate under the guidance of a transrectal ultrasound probe, specifically, a biopsy needle can be attached to the surface of the probe along its length. Examples include a type (see FIG. 4 described later) and a type that has a through hole that penetrates the probe diagonally in the transverse direction and allows a biopsy needle to be inserted into the through hole (see FIG. 3 described later).
  • the ultrasonic probe is inserted into the rectum, and the image forming apparatus grasps the guide tube transperinally while grasping the positional relationship between the target location and the protruding tip of the puncture needle. It can also be inserted directly and advanced to the target location.
  • a normal abdominal ultrasound probe In the case of a limb ⁇ face, a normal superficial-like ultrasonic probe can be used), the probe can be attached to the skin, and the probe can be operated and externally attached to each ultrasonic probe. Through the dollar guidance, it is better to insert this guide tube and advance toward the target site.
  • the puncture needle is pulled out from the guide tube while holding the inserted guide tube as it is. Thereafter, the stimulating electrode is inserted into the inserted guide tube so that the puncture needle is replaced by the stimulating electrode. Since the access path to the target site has already been formed by the puncture needle, simply inserting the stimulating electrode into the guide tube and proceeding, the distal end of the distal end of the stimulating electrode will become the guide tube. Protruding from the distal end of the target.
  • a current is supplied to the stimulation electrode that has reached the target location at the most distal end, and a current flows through the target location. Then, by monitoring the response caused by the stimulation of the nerve by the current, it is determined whether the nerve is running at or near the target location.
  • An example of such a response is the pressure of the corpus cavernosum when stimulating the erectile nerve.
  • the target location is a location where the erectile nerve is predicted to be running, and whether or not the nerve is actually running at that location can be known only by applying a current. If no response due to electrical stimulation is observed even when current is applied, slightly change the position of the tip of the stimulation electrode. Since the path to the first target point has already been formed, such a change is made while looking at the display of the image forming apparatus. This can be done by manipulating the guide tube so that it is located at a suitable target location, and then applying a current again to observe the response. In this way, by repeatedly selecting a new target location, applying a current thereto, and confirming whether or not the stimulation has been performed, it is possible to ultimately specify the erectile nerve travel location.
  • the force changing the target portion while the inserted guide tube is still inserted is still inserted.
  • the inserted guide tube is removed together with the electrode, and the guide tube force is changed. Withdrawing the electrode, inserting the puncture needle, and inserting the guide tube with the tip of the puncture needle protruding as described above, and pushing the tip toward a new target location It is possible.
  • FIG. 1 is a perspective view schematically showing each component constituting a kit of the nerve stimulation device of the present invention.
  • FIG. 2 shows a puncture needle inserted into a guide tube and the distal end portion thereof is positioned at the distal end of the guide tube.
  • a cross-sectional view schematically illustrates a state in which the end force is protruding, and a state in which the stimulation electrode is inserted into the guide tube instead of the puncture needle, and the distal end of the electrode protrudes from the distal end of the guide tube.
  • the kit of the present invention comprises a guide tube 10 shown in FIG. 1 (a), a puncture needle 12 shown in FIG. 1 (b), and a stimulation electrode 14 in FIG. 1 (c).
  • FIG. 1 typical dimensions of the components constituting the kit are also described.
  • the guide tube 10 is, for example, a tubular member such as stainless steel, and the gripping element 16 is arranged at one end, that is, around the proximal end.
  • the gripping element 16 may have an appropriate V or deviation as long as the portion can be gripped with a finger to operate the guide tube.
  • the gripping element 16 is, for example, in the form of a ring of a ceramic material or a plastic material (for example, polytetrafluoroethylene (for example, Teflon), ethylene propylene resin, etc.) fitted around the guide tube as shown in the figure. Good.
  • the guide tube 10 has a hollow portion into which the puncture needle 12 or the stimulation electrode 14 is inserted.
  • the inner diameter of the hollow portion is such that the insertion of the puncture needle 12 or the stimulation electrode 14 is easy, and the puncture needle is located inside the hollow portion. Is slightly smaller than the outer diameter of the puncture needle 12 or the stimulating electrode 14 so as not to move largely in the radial direction. Usually, it is preferable that the puncture needle 12 or the stimulation electrode 14 be slidable or slidable in the guide tube 10. As an example, when using a stainless steel guide tube, a tube with an outer diameter of 18G (gauge) and an inner diameter of 20G can be used, in which case the outer diameter of the puncture needle and the stimulation electrode is substantially 20G. Eh.
  • the puncture needle 12 can be inserted into the guide tube 10 as described above, as long as it can puncture a predetermined part of the body widely used in the medical and diagnostic fields. .
  • the tip 20 is sharpened so that the tissue can be incised and pushed into it by pushing.
  • the tip portion 20 has fine irregularities on the surface so as to increase the reflection of ultrasonic waves. Such fine irregularities may be provided on the entire distal end portion 20 or on a part thereof, particularly on the most distal end portion thereof.
  • the puncture needle has a sharp end surface whose distal end portion can be punctured.
  • the puncture needle is preferably a solid metal (for example, stainless steel) needle.
  • the puncture needle becomes substantially only the force of such a needle and substantially eliminates other elements.
  • a puncture needle has no further electrodes for stimulating nerves, or does not have such a function.
  • the puncture needle may be formed from a thin tubular body called force-Yure.
  • a grasping element 18 is arranged around the proximal end of the puncture needle 12.
  • This gripping element 18 may be the same as the gripping element of the guide tube which may be any suitable one as long as the part can be pinched with a finger to operate the puncture needle.
  • the distal tip section 20 is configured to project a predetermined length from the distal end 22 of the guide tube.
  • the stimulation electrode 14 is composed of the conductor element 24 and the insulating material 26 arranged around the conductor element 24, and can be inserted into the guide tube 10 instead of the puncture needle 12 as described above.
  • the distal tip 28 of the stimulating electrode especially the tip at that time, is dull, so that even when the tip 28 moves inside the body, it does not damage surrounding objects (eg, tissues, blood vessels, nerves, etc.). It is composed of For example, the distal end portion has a dull end surface as described above, is formed into a curved surface (for example, a dome-shaped curved surface) as shown in the figure, and is preferably mirror-finished.
  • the distal tip portion 28 of the stimulating electrode is adapted to increase ultrasound reflection on its surface, or on a portion of the surface (especially the most distal portion), as in a puncture needle. It may have fine irregularities (see 60 in FIG. 1 (c)).
  • the unevenness provided on the tip of the puncture needle or the stimulation electrode may be in any suitable form, but for example, a regular concave portion such as a lattice-shaped (or cross-shaped) groove may be formed on the surface. Can be provided by forming it can. Various forms of depressions that are regularly or irregularly scattered may be provided on the surface.
  • the tip By providing the tip with irregularities in this manner, for example, during an operation, when an operator observes the position of the tip of the puncture needle or the stimulation electrode while viewing the image with an ultrasonic image forming apparatus, the position of the tip is changed. Since it can be confirmed on the display of the image forming apparatus, it is possible to accurately identify the nerve running location.
  • a gripping element 30 is arranged around the proximal end portion of the stimulation electrode 14.
  • This grasping element 30 may be the same as the grasping element 18 of the puncture needle, which may be any suitable one as long as the part can be grasped with a finger to operate the stimulation electrode.
  • the distal tip portion 28 of the electrode 14 is configured to project a predetermined length from the distal end 22 of the guide tube, preferably substantially the same length as the tip portion of the puncture needle.
  • the conductor element 24 is made of a material having good conductivity with respect to electric current, and may be generally in the form of a rod. As described in the Background Art section, materials generally used for electrodes for stimulating nerves can be used. Generally, metals (eg, copper, stainless steel, gold, platinum, etc.) are preferred. As shown in FIG. 1 (c), a lead 58 (electric wire, electric cable, etc.) is connected to the proximal end 32 of the stimulation electrode so that current can be supplied from the current supply device 33 to the stimulation electrode. Is configured.
  • the conductor element 24 may be in any form as long as it can supply a current to the target portion.In one preferred embodiment, as shown, the tip portion 28 is formed to be blunt, and large. However, the tip portion and other portions may have substantially the same diameter.
  • the insulating material 26 surrounding the periphery of the conductor element 24 may be made of any suitable material, as described in the Background Art section, as described in the Background Art section. Materials and materials commonly used for insulating electric wires can be used. In general, it is preferable to use an electrically insulating material such as a ceramic material or a plastic material (for example, silicone rubber, polytetrafluoroethylene (for example, Teflon), ethylene-propylene resin, polyethylene, or polyimide). Such an electrically insulating material is preferably in the form of a coating around the conductor element!
  • the stimulating electrode 14 as described above, except for the feature that it can be inserted into the guide tube 10 and, when inserted, its distal end 28 projects from the distal end 22 of the guide tube, It has the same structure as the electrodes used to stimulate nerves as described in the technology section.
  • the kit is constructed such that the distance from the distal end 22 of the guide tube to the distal end of the tip is substantially the same.
  • the tip of the stimulation electrode inserted in place of the puncture needle can reach substantially the same location as the target location where the tip of the puncture needle inserted into the guide tube is located.
  • the target area can be electrically stimulated.
  • FIG. 2 (c) Another embodiment of the stimulation electrode 14 is schematically shown in cross section in Fig. 2 (c).
  • the electrode 14 is composed of two conductive elements 24 and an insulating material 26 that electrically insulates them from each other and is located around the conductive elements and between the conductive elements. It is exposed at the tip 28 of the electrode 14 for use.
  • Such a stimulating electrode is similar to the stimulating electrode described above in that, after the tip 28 reaches the target location, a voltage is applied between one conductor element and the other conductor element. Electric current flows between the two conductor elements through the location, and as a result, nerves running in the immediate vicinity of the target location can be stimulated.
  • the target portion through which the current flows becomes extremely local, so that the accuracy of specifying the running location of the nerve is improved and the current passing path is limited to the local portion.
  • the two conductor elements extend in parallel in the stimulation electrode, as shown, so that one conductor element is surrounded by the other conductor element (e.g., a central conductor). Two concentric conductors composed of a tubular conductor force around it) There may be two conductor elements.
  • the stimulation electrode using a single conductor element 24 as shown in FIG. 2 (b) it is necessary to connect the counter electrode to a part of the body.
  • the puncture needle 12 is inserted into the guide tube 10, and its distal end portion 20 projects from the distal end portion 22 of the guide tube as shown in FIG. 2 (a).
  • a transrectal ultrasound probe is prepared.
  • the probe may be a probe that is commonly used for obtaining a biopsy sample rectal rectally.
  • FIG. 3 schematically shows such an ultrasonic probe 34 in a perspective view.
  • FIG. 4 schematically shows a state in which another type of probe 40 is inserted into the rectum.
  • the probe 34 shown in FIG. 3 has an ultrasonic irradiation unit 36 for emitting an ultrasonic wave toward a target site in order to form an image of the target site at a distal portion of the probe. It has a through hole 37 that passes through the probe at an angle to the direction.
  • the through hole 37 has an opening 38 and an opening 39 at its distal end and its proximal end.
  • the probe 34 is inserted into the rectum such that the opening 38 at the distal end is inside the rectum and the opening 39 at the proximal end is outside the body.
  • the guide tube into which the puncture needle has been inserted through the opening 39 at the end is inserted into the through hole 37 and protrudes from the opening 38 at the distal end.
  • FIG. 3 (b) a state where the lateral force is also seen
  • FIG. 3 (c) a state where the upward force is seen
  • the through holes provided inside the probe are schematically indicated by broken lines.
  • the ultrasonic irradiation section 36 of the ultrasonic probe is inserted into the rectum so that the opening 38 is located inside the rectum and the opening 39 is located outside the body.
  • the guide tube 10 into which the puncture needle 12 is inserted is inserted through the proximal opening 39 provided in the ultrasonic probe, the guide tube into which the puncture needle 12 is inserted passes through the through hole inside the probe. Then, as shown in FIG. 3 (b), it protrudes from the opening 38 on the distal side, and then advances toward the target portion.
  • the ultrasonic irradiation section 36 of the ultrasonic probe is irradiated with ultrasonic waves toward the prostate, and the guide tube 10 into which the puncture needle 12 is inserted advances.
  • Puncture with a protruding distal end of the guide tube The appearance of the tip of the needle tip reaching the target site near the prostate 44 is schematically shown in FIG.
  • an ultrasonic probe 40 of a type in which a guide tube is inserted into the rectum along the outside of the probe is inserted into the rectum 42, You.
  • Figs. 3 and 4 the tip of the puncture needle is not shown for simplicity, and the guide tube and the puncture needle are shown integrally.
  • the operation of inserting the guide tube toward the target site in this manner can be generally performed by utilizing the needle-guidance for needle biopsy using a transrectal ultrasonic diagnostic apparatus.
  • each can be worn externally using the appropriate ultrasound probe.
  • the guide tube stops moving, and then guides the puncture needle 12 while holding the guide tube as it is. Remove the tube from the tube 10 and leave the guide tube inside the body.
  • the stimulation electrode 14 is inserted into the guide tube, and the stimulation electrode is advanced until the gripping element 30 contacts the gripping element 16 of the guide tube.
  • the stimulating electrode tip 28 extends a predetermined length from the distal end 22 of the guide tube.
  • the tip of the stimulating electrode 14 is located at the position where the tip of the puncture needle 12 is located. That is, the tip of the stimulation electrode is located at the target location. In this state, when a current is supplied to the stimulation electrode, a current can be supplied to a target location. If a nerve is located at or near the target location, the nerve is stimulated.
  • the nerve When a nerve is stimulated by an electric current, the nerve shows some response. When the erectile nerve is stimulated, the response is to increase the corpus cavernosum pressure. Therefore, when a current is applied to the stimulating electrode while monitoring the cavernous body pressure and an increase in the pressure is observed, it is understood that there is a place where the erectile nerve runs near the tip of the stimulating electrode.
  • the location where the nerve runs is specified.
  • the current value to be supplied may be any appropriate value, but usually a current of 0.1 to 30 mA is supplied. Preferably, a current of 120 mA is supplied.
  • the stream is provided with a pulse duration of, for example, 800 milliseconds, which is preferably provided in a pulsed manner.
  • the waveform of the current to be stimulated may be of any type, for example, a sine wave, a rectangular wave, a triangular wave, a pulse wave, or the like. Except for special cases, the frequency of the stimulating current should be a low frequency.
  • the current value to be supplied preferably uses a current of 8 to 18 mA.
  • the stimulation electrode 14 may be moved slightly together with the guide tube 10, and then the current may be supplied again to monitor the response.
  • the stimulation electrode 14 is pulled out of the body together with the guide tube 10, the puncture needle 12 is inserted into the guide tube 10 and puncture is directed to another target portion, and then puncture is performed in the same manner as above.
  • the needle 12 may be replaced with the stimulating electrode 14 so that the tip of the stimulating electrode reaches another target location, and an electric current may be applied to try to identify the location of the nerve.
  • the location of the tip of the stimulation electrode is determined using an image forming apparatus using an ultrasonic probe as described above. In addition to identifying the location where the laparoscopic scalpel is running, it is possible to check the position of the laparoscopic scalpel and take care that the laparoscopic scalpel does not unnecessarily approach the tip of the stimulation electrode.
  • the use of the device of the present invention makes it possible to specify the location where the erectile nerve runs near the prostate. If such a location of the erectile nerve is used in laparoscopic prostate cancer surgery, which is developing with the needs of the times, it is not intended because the position of the laparoscopic scalpel and the erectile nerve can be grasped. Since the possibility of preventing erectile nerve damage is increased, the outcome of this operation can be improved from the viewpoint of reducing erectile dysfunction, which is a complication of surgery.
  • a radioactive substance for example, eodo 125
  • the nerve stimulation device of the present invention specifies the nerve transit location in advance, and implants the radioactive substance away from the nerve translocation point to obtain a neuropathy. Can be avoided.
  • the present invention can be used in the following cases:
  • pelvic cancer e.g., prostate cancer, bladder cancer, rectal cancer, etc.
  • pelvic cancer e.g., prostate cancer, bladder cancer, rectal cancer, etc.
  • increased cavernous pressure smooth muscle contraction to erect the penis
  • increased bladder pressure smooth muscle contraction to urinate
  • sphincter contraction The smooth muscle contraction reaction that prevents leakage of urine and stool is observed as a response.
  • the internal pressure of the bladder increases as a response to nerve stimulation (urination
  • the response is to observe the contractile response of the smooth muscle to perform the contraction and the contraction pressure of the sphincter muscle (the contraction response of the smooth muscle to prevent leakage of urine and stool).
  • the present invention can also be used in a medical treatment called “nerve block”, which is mainly performed for the purpose of blocking nerves related to pain, paralysis and convulsions in various parts of the body and reducing the accompanying suffering.
  • nerve block a medical treatment
  • the spastic contraction of the skeletal meat of the face is directly observed with the eyes as a response, and the local pain in each part of the limb
  • the spastic contraction of skeletal muscle in the same area as the painful area is directly visually observed as a response.
  • drugs required for nerve block It can be selectively administered and acted on.
  • the pain associated with herniated discs in the lower back and neck can also be used to pinpoint the nerves running out of the spinal cord and to perform a medical procedure called “nerve block”.
  • the present invention can also be used to identify plexuses (portions where various nerves intersect in a mesh pattern) and ganglia (thickness, peripheral nerves, and narrow and peripheral nerves are branched and connected).
  • ganglia thinness, peripheral nerves, and narrow and peripheral nerves are branched and connected.
  • the resulting stimulus response can be recognized at multiple places at the same time, so that it is possible to identify the presence of stimulating electrodes in the neural complex. It can also be used to perform medical procedures on the site.
  • the stimulation electrode is removed from the guide tube while the guide tube is left in the body as it is, and the guide tube is removed.
  • a predetermined drug or the like may be injected into the body via the body.
  • injection of a fluid such as a drug through the guide tube allows the drug to be applied to the target location and the nerve traveling at or near Z. Etc. can be supplied.
  • the drug examples include an anesthetic, an analgesic, various markers (eg, a stain such as ink), and a therapeutic drug (eg, a nerve growth factor or a steroid hormone as a drug for suppressing perineural inflammation).
  • a therapeutic drug eg, a nerve growth factor or a steroid hormone as a drug for suppressing perineural inflammation.
  • neurotoxins such as ethanol, formalin, and botulinum toxin may be used in special situations in which nerve function should no longer be preserved in order to completely eliminate pain.
  • injecting fluids such as drugs attach the end of the syringe to the proximal end of the guide tube, either directly or through an appropriate connector or connector tube as needed, and use the syringe to transfer the fluid. Can be injected.
  • the fluid may be a liquid, a gas or a mixture thereof, including a solid content as necessary.
  • the present invention provides a method for supplying a predetermined fluid (for example, a liquid such as a drug) to a target site, using the above-described nerve stimulation device or kit thereof.
  • a predetermined fluid for example, a liquid such as a drug
  • the fluid injection method of the present invention further includes adding the fluid via the guide tube after performing the nerve running point confirmation method.
  • the fluid is necessary at the target site and is not particularly limited as long as it can be transported through the guide tube.
  • the supply method of the present invention is suitable for supplying a drug as described above. More specifically, it can be used to supply a drug to a given nerve to block, ie, block, the function of that nerve. For example, it can be used in a pain clinic for peripheral nerve blocks, ganglion blocks, and the like. Cross-reference of related applications

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Abstract

Un nécessaire qui constitue un dispositif de stimulation des nerfs comprenant un tube guide, une aiguille d'acupuncture à introduire dans le tube guide, et une électrode de stimulation à insérer dans le tube guide. Ce nécessaire peut s'utiliser pour un procédé de stimulation des nerfs, un procédé de traitement médical utilisant ce procédé, et un procédé d'apport de médicaments.
PCT/JP2004/017774 2003-12-02 2004-11-30 Necessaire s'utilisant comme dispositif de stimulation des nerfs Ceased WO2005058411A1 (fr)

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JP2003403365 2003-12-02
JP2003-403365 2003-12-02

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WO2005058411A1 true WO2005058411A1 (fr) 2005-06-30

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112041020A (zh) * 2018-02-22 2020-12-04 首尔大学医院 在手术中绘制海绵体神经
CN112426621A (zh) * 2020-12-16 2021-03-02 常州瑞神安医疗器械有限公司 一种电极导引装置
CN114177517A (zh) * 2022-02-15 2022-03-15 杭州神络医疗科技有限公司 一种神经刺激电极以及神经刺激装置
CN114938979A (zh) * 2022-04-02 2022-08-26 伊索曼(中山)医疗器械有限公司 减压件植入套件及其使用方法

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Publication number Priority date Publication date Assignee Title
JPS55156753U (fr) * 1979-04-26 1980-11-11
JPH0652831U (ja) * 1992-12-28 1994-07-19 コーア株式会社 針治療器
JPH11506956A (ja) * 1995-06-07 1999-06-22 ユーロムド コーポレイション 神経を探知する装置および方法
JP2002522167A (ja) * 1998-08-17 2002-07-23 メドトロニック・インコーポレーテッド エコー生成コーティングを備えた医療装置

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS55156753U (fr) * 1979-04-26 1980-11-11
JPH0652831U (ja) * 1992-12-28 1994-07-19 コーア株式会社 針治療器
JPH11506956A (ja) * 1995-06-07 1999-06-22 ユーロムド コーポレイション 神経を探知する装置および方法
JP2002522167A (ja) * 1998-08-17 2002-07-23 メドトロニック・インコーポレーテッド エコー生成コーティングを備えた医療装置

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112041020A (zh) * 2018-02-22 2020-12-04 首尔大学医院 在手术中绘制海绵体神经
JP2021517849A (ja) * 2018-02-22 2021-07-29 ソウル ナショナル ユニバーシティ ホスピタル 手術中における海綿体神経のマッピング
JP7247229B2 (ja) 2018-02-22 2023-03-28 ソウル ナショナル ユニバーシティ ホスピタル 手術中における海綿体神経のマッピング
JP2023088951A (ja) * 2018-02-22 2023-06-27 ソウル ナショナル ユニバーシティ ホスピタル 臓器付近の海綿体神経をマッピングするシステム
CN112426621A (zh) * 2020-12-16 2021-03-02 常州瑞神安医疗器械有限公司 一种电极导引装置
CN114177517A (zh) * 2022-02-15 2022-03-15 杭州神络医疗科技有限公司 一种神经刺激电极以及神经刺激装置
CN114938979A (zh) * 2022-04-02 2022-08-26 伊索曼(中山)医疗器械有限公司 减压件植入套件及其使用方法

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