JP2014184052A - Nerve stimulation device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a nerve stimulation device capable of more accurately acquiring an electrocardiographic signal.SOLUTION: A nerve stimulation device 1 which is indwelled in an organism and performs electric stimulation on a nerve comprises: a nerve stimulation electrode 20 including stimulation electrodes 33A, 33B for applying the electric stimulation to the nerve and a lead unit 21 whose one end part is connected to the stimulation electrode; a stimulation generation device 10 which is connected to the other end part of the lead unit and generates a nerve stimulation signal for the application of the electric stimulation; and two or more detection electrodes 24, 25, at least one of which is provided on the lead unit so as not to be separated from the lead unit.

Description

  The present invention relates to a nerve stimulation device, and more particularly to a nerve stimulation device including an electrode that is placed in a blood vessel and stimulates a nerve.

Conventionally, research on treatment methods by applying electrical stimulation to nerve tissue has been performed. As a nerve stimulating device used for such an application, it has been proposed to place an electrode in a blood vessel and stimulate the nerve adjacent to the blood vessel through the blood vessel wall by the electrode. Examples of the target nerve include the vagus nerve, and by stimulating this, a desired effect such as lowering the heart rate is brought about.
In the case of treatment that stimulates the vagus nerve, it is necessary to perform stimulation by detecting an event such as an increase in heart rate or tachycardia. For this reason, a mechanism for detecting biological information such as a heart rate and an electrocardiographic waveform is connected to the nerve stimulation device, and the input biological information is monitored.
In the nerve stimulation device described in Patent Document 1, an electrocardiogram signal is acquired by a plurality of bipolar leads placed in a blood vessel. This bipolar lead is configured to allow cardiac pacing in addition to the acquisition of an electrocardiographic signal.

Special table 2007-510467 gazette

In the nerve stimulation device described in Patent Document 1, an electrode that performs nerve stimulation and a bipolar lead that acquires an electrocardiogram signal are close to each other and are disposed in blood with low electrical impedance. If performed, the electrocardiogram signal may not be correctly detected due to the influence of the stimulation pulse.
When noise derived from a stimulation pulse is mixed in an electrocardiogram signal, there is a problem that it is difficult to correctly measure the heart rate.

  This invention is made | formed in view of the said situation, Comprising: It aims at providing the nerve stimulation apparatus which can acquire an electrocardiogram signal more correctly.

  The present invention relates to a nerve stimulation device that is placed in a living body and performs electrical stimulation on nerves, and includes a stimulation electrode that applies the electrical stimulation to nerves, and a lead portion having one end connected to the stimulation electrode. A nerve stimulation electrode having a nerve stimulation signal that is connected to the other end of the lead portion and generates a nerve stimulation signal for applying the electrical stimulation; and at least one of the leads is not separated from the lead portion. It comprises two or more biological information acquisition electrodes provided on the part.

  The biological information acquisition electrode provided on the lead part may have an adhesive part and be adhesively fixable on the surface of the biological body.

One of the biological information acquisition electrodes may be provided on the stimulus generator.
At this time, the biological information acquisition electrode provided on the stimulus generator may have an adhesive portion and can be adhesively fixed to the biological surface.

  Three or more biological information acquisition electrodes may be provided, one of which may be a reference electrode, and an electrocardiographic waveform may be acquired.

  According to the nerve stimulation electrode of the present invention, an electrocardiographic signal can be acquired more accurately.

It is a mimetic diagram showing the whole nerve stimulation device composition concerning a first embodiment of the present invention. It is a functional block diagram of the nerve stimulation apparatus. It is a figure which shows the state in which the same nerve stimulating device was detained in the patient. It is a schematic diagram which shows the whole structure of the modification of the same nerve stimulation apparatus. It is a schematic diagram which shows the whole structure of the modification of a nerve stimulation apparatus. It is a schematic diagram which shows the whole structure of the nerve stimulation apparatus which concerns on 2nd embodiment of this invention.

A first embodiment of the present invention will be described with reference to FIGS. 1 to 4B.
FIG. 1 is a schematic diagram showing an overall configuration of a nerve stimulation apparatus 1 of the present embodiment. The nerve stimulation device 1 includes a stimulation generator 10 that generates a nerve stimulation signal and a nerve stimulation electrode 20 that is placed in a blood vessel of a patient or the like.

The nerve stimulation electrode 20 is placed in a blood vessel of a patient or the like, applies a nerve stimulation signal generated by the stimulation generator 10 to a living tissue, and performs electrical stimulation to the nerve.
The nerve stimulation electrode 20 includes an indwelling unit 30 that is held in a blood vessel, and a lead unit 21 that connects the indwelling unit 30 and the stimulation generator 10.

The indwelling unit 30 includes a plurality of urging members 31 and a pair of stimulation electrodes 33A and 33B attached to one of the urging members 31.
Each biasing member 31 has a rigidity that can maintain a certain shape against deformation of the indwelling blood vessel wall, and is preferably formed using, for example, a nickel-titanium superelastic wire or the like. be able to. The surface of each urging member 31 is covered with a biocompatible resin such as polyurethane (not shown) so that the blood vessel wall is hardly damaged. On the surface of the urging member 31, a coating or a medicine for preventing thrombus may be further disposed.

  As shown in FIG. 1, the proximal end side of each urging member 31 is connected to the distal end portion of the lead portion 21. As shown in FIG. 2, each urging member 31 is first radially outward of the lead portion 21 and distal to the distal end side of the lead portion 21 (hereinafter referred to as the “leading portion 21”) in a natural state where no external force acts. , Referred to as “front”), and then bundled close to the axis of the lead portion 21 while gently curving.

  The pair of stimulation electrodes 33 </ b> A and 33 </ b> B is disposed in one longitudinal direction intermediate portion of the plurality of biasing members 31, and the conductive electrode surface is exposed at least at a part of the outer peripheral surface. As a material of the stimulation electrodes 33A and 33B, a metal material excellent in biocompatibility is preferable, and examples thereof include a noble metal material such as a platinum iridium alloy. In the present embodiment, the stimulation electrode 33A on the distal end side is a negative electrode, and the other stimulation electrode 33B is a positive electrode, and each is connected to the stimulation generator 10 by wiring not shown. The number of stimulation electrodes is not limited to a pair, and a plurality of stimulation electrodes may be provided.

  The lead portion 21 has a known configuration including an insulating coating 22 and a connector 23, and is configured to be long and flexible. The wiring connected to the stimulation electrodes 33 </ b> A and 33 </ b> B passes through the coating provided on the biasing member 31 and the insulating coating 22 of the lead portion 21, and is connected to the stimulation generator 10 via the connector 23.

A pair of detection electrodes (biological information acquisition electrodes) 24 and 25 are attached to the lead portion 21 on the stimulus generator 10 side. The detection electrodes 24 and 25 have conductive electrode portions 24a and 25a and adhesive pads 24b and 25b, respectively. Each electrode part 24a, 25a is connected with the irritation | stimulation generator 10 via the wiring which is not shown in figure arrange | positioned in the lead part 21. FIG. The adhesive pads 24b and 25b are known ones that can be repeatedly adhered and peeled to the body surface of a patient or the like, and support the lead part 21 and the electrode parts 24a and 25a on the body surface by being adhered.
The pair of detection electrodes 24 and 25 are attached so as not to be separated from the lead portion 21 but always on the lead portion 21 so that the lead portion 21 can be suitably supported.

FIG. 2 is a block diagram of the stimulus generator 10. The stimulus generation device 10 includes a stimulus generation unit 11 that generates a nerve stimulation signal, a biological information acquisition unit 12 that acquires biological information such as a heart rate based on a potential change detected by the detection electrodes 24 and 25, and a stimulus generation device. And a control unit 13 that controls the entire system 10.
The biological information acquisition unit 12 acquires an electrocardiogram waveform based on the potential change of the living body detected by the detection electrodes 24 and 25, and acquires the heart rate of the patient or the like based on the RR interval or the like of the electrocardiogram waveform. To do.
The control unit 13 is connected to the stimulation generation unit 11 and the biological information acquisition unit 12, and generates a stimulation so as to generate a nerve stimulation signal when the heart rate received from the biological information acquisition unit 12 becomes a predetermined condition. The unit 11 is instructed. The mode of the neural stimulation signal may be set in advance in the form of a program or the like in the control unit 13 in advance, or an interface unit for input is provided in the stimulation generating device, and can be set by an operation input by a user, a doctor, or the like You may do it.
The stimulus generator 11 is connected to a power source (not shown) built in the stimulus generator 10 and generates a nerve stimulus signal in accordance with an instruction from the controller 13. The generated nerve stimulation signal is sent to the stimulation electrodes 33A and 33B through the lead portion 21 and applied to the living body.

Operation during use of the nerve stimulation apparatus 1 having the above configuration will be described.
The surgeon makes a small incision in the patient's blood vessel to form an opening, and inserts a cylindrical introducer or the like into the blood vessel. Then, each urging member 31 of the indwelling portion 30 is deformed into a linear shape along the axis of the lead portion 21 and then inserted into a tubular member such as a sheath, and the tubular member is inserted into an introducer or the like. When the distal end portion of the tubular member is moved to the indwelling site close to the stimulating nerve and the indwelling portion 30 is protruded from the distal end of the tubular member, each biasing member 31 returns or returns to the original shape, and the inner wall of the blood vessel The stimulation electrodes 33A and 33B are held in the blood vessel in contact with the blood vessel wall in contact with the blood vessel wall.

When the position of the indwelling portion 30 is determined, the operator removes the introducer by removing or tearing the introducer. Thereby, the indwelling part 20 is indwelled in the predetermined position in a patient's blood vessel. The tubular member may or may not be removed.
As shown in FIG. 3, the pair of detection electrodes 24 and 25 are provided on the lead portion 21 located outside the body in a state where the indwelling portion 30 is indwelled at the predetermined position. The operator arranges the lead part 21 outside the body so as to lie over the body surface, and attaches the adhesive pads 24b, 25b of the detection electrodes 24, 25 to the patient's skin. When the stimulus generator 10 is fixed to the patient's body surface, clothes, or the like with an adhesive tape or the like, the placement of the entire nerve stimulator 1 is completed.

  While the nerve stimulation electrode 20 is in place, the biological information acquisition unit 12 acquires and monitors the heart rate as needed based on the information detected by the detection electrodes 24 and 25. When the heart rate reaches a predetermined condition, a nerve stimulation signal is generated by the stimulation generation unit 11 according to an instruction from the control unit 13 and applied to the stimulation electrodes 33A and 33B. Treatment is performed by stimulating the target nerve through the blood vessel wall by electrical stimulation applied to the tissue from the stimulation electrodes 33A and 33B.

  According to the nerve stimulation apparatus 1 of the present embodiment, the detection electrodes 24 and 25 for detecting information for obtaining biological information are provided on the lead portion 21 located outside the body when the indwelling portion 30 is placed. A sufficient distance is maintained between the stimulation electrodes 33A and 33B for performing nerve stimulation. As a result, noise due to nerve stimulation is unlikely to enter the detection electrodes 24 and 25, and accurate biological information can be acquired and appropriate treatment can be performed.

  In addition, since the detection electrodes 24 and 25 are always provided on the lead portion 21, the wiring does not extend further from the lead portion, and the linear portion outside the body is substantially made only of the lead portion 21. It is possible to simplify the apparatus configuration and reduce the troublesomeness of the patient at the time of indwelling.

  Furthermore, since the detection electrodes 24 and 25 have adhesive pads 24b and 25b, the lead portion 21 can be fixed to the body surface by attaching the adhesive pad to the body surface such as skin. As a result, indwelling can be performed easily, and the position of the lead part outside the body after indwelling can also be stabilized. Since the deviation of the lead part outside the body causes the deviation of the indwelling part 30 in the body, it also contributes to the certainty of treatment by the nerve stimulation apparatus 1.

  In the present embodiment, an example in which both of the pair of detection electrodes are located outside the body when the indwelling unit 30 is placed in the body has been described. However, as shown in FIGS. You may arrange | position to the indwelling part 30, or may be arrange | positioned on the lead part 21 located in a body. However, the closer the electrode portion 24a is to the stimulation electrodes 33A and 33B, the higher the probability that noise will enter during nerve stimulation. Therefore, when placing the electrode portion 24a in the body, it is preferable to place it as far away from the stimulation electrode as possible. .

  Next, a second embodiment of the present invention will be described with reference to FIG. The difference between this embodiment and the first embodiment is that a reference electrode is further provided as a biological information acquisition electrode. In the following description, the same components as those already described are denoted by the same reference numerals and redundant description is omitted.

  FIG. 6 is a schematic diagram showing the configuration of the nerve stimulation device 51 of the present embodiment. A reference electrode 52 is provided on the outer surface of the stimulus generator 10. The reference electrode 52 has an electrode part 52a and an adhesive part 52b. The electrode unit 52a is connected to the biological information acquisition unit 12 of the stimulus generator. As the adhesive part 52b, the thing similar to the adhesive parts 24b and 25b can be used.

When the nerve stimulating device 51 is placed, if the adhesive portion 52b is affixed to the body surface, the stimulus generator 10 is fixed to the body surface together with the electrode portion 52a.
After indwelling, an electrocardiographic waveform is acquired based on tripolar information obtained by adding the reference electrode 52 to the detection electrodes 24 and 25.

Also in the nerve stimulation apparatus 51 of the present embodiment, accurate biological information can be acquired and appropriate treatment can be performed in the same manner as the nerve stimulation apparatus 1 of the first embodiment.

In addition, since the reference electrode 52 is provided, an electrocardiographic waveform can be acquired from three poles. As a result, it is possible to reduce the influence of the fluctuation of the signal baseline due to noise or body movement mixed in the electrocardiogram signal by using a known correction method, and it is possible to further improve the accuracy of the acquired biological information.
Furthermore, since the reference electrode 52 is provided on the stimulus generator 10, the stimulus generator can be fixed by fixing the reference electrode, and the placement operation can be simplified.

  In the present embodiment, the example in which the reference electrode is provided on the stimulus generator has been described. Although the effect of simplifying the indwelling operation described above is lost, the position where the reference electrode is indwelled is not limited to this, and may be provided on the lead part 21 or the indwelling part 30. In general, since the bipolar electrode is installed at a position sandwiching from the upper right to the lower left with the heart as the center, a large signal level can be obtained, which is advantageous for heart rate measurement. In this case, it is desirable that the reference electrode is positioned at an equal distance from the other two poles on the upper left or lower right with respect to the heart. However, the effect of noise reduction can be expected even when the lead wires are not routed at all at equal intervals.

  The embodiments of the present invention have been described above. However, the technical scope of the present invention is not limited to the above-described embodiments, and the combinations of the components or the components may be changed without departing from the spirit of the present invention. It is possible to make various changes to or delete them.

  For example, in the second embodiment described above, the example in which the reference electrode is provided on the stimulus generator has been described, but instead of this, one of the detection electrodes may be provided in the stimulus generator. If it does in this way, even if it is composition which is not provided with a reference electrode, an electrode fixed to a body surface and a stimulus generating device can be fixed by the same operation.

  Further, the detection electrode and the reference electrode may be configured to be detachable from the lead portion by using a known snap button mechanism or the like. At this time, if a plurality of snap button mechanisms such as detection electrodes or more are provided on the lead portion, the attachment position of the detection electrodes can be adjusted according to the patient or the like. Furthermore, if an adhesive pad that does not have an electrode portion is attached to a snap button mechanism to which a detection electrode or the like is not attached, the lead portion can be fixed to the body surface in a more stable state.

DESCRIPTION OF SYMBOLS 1, 51 Neural stimulation apparatus 10 Stimulation generating apparatus 20 Neural stimulation electrode 21 Lead | read | reed parts 24 and 25 Detection electrode (biological information acquisition electrode)
24b, 25b, 52b Adhesive portions 33A, 33B Stimulation electrode 52 Reference electrode (biological information acquisition electrode)

Claims (5)

A nerve stimulation device that is placed in a living body and electrically stimulates nerves,
A nerve stimulation electrode having a stimulation electrode for applying the electrical stimulation to a nerve, and a lead portion having one end connected to the stimulation electrode;
A stimulation generator that is connected to the other end of the lead portion and generates a nerve stimulation signal for applying the electrical stimulation;
Two or more biological information acquisition electrodes provided on the lead portion so that at least one is not separated from the lead portion;
A nerve stimulation device comprising:   The nerve stimulation apparatus according to claim 1, wherein the biological information acquisition electrode provided on the lead portion has an adhesive portion and can be adhesively fixed to the surface of the biological body.   The nerve stimulation electrode according to claim 1, wherein one of the biological information acquisition electrodes is provided on the stimulation generator.   The nerve stimulation apparatus according to claim 3, wherein the biological information acquisition electrode provided on the stimulation generator has an adhesive portion and can be adhesively fixed to the surface of the biological body.   5. The nerve stimulation apparatus according to claim 1, wherein three or more biological information acquisition electrodes are provided, one of which is used as a reference electrode to acquire an electrocardiogram waveform. 6.

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