JP2013162886A - Lead, and tissue stimulation system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a lead suppressed to a small outer diameter while suppressing the positional shift of the lead when the lead is introduced into a blood vessel.SOLUTION: A lead 10 includes a lead body 20 formed of a linear member having insulating properties, a pair of electrodes 25 and 26 provided to the lead body so as to be exposed to the outside and an electric wire 30 provided in the lead body to be electrically connected to an electrode and extended toward the base end of the lead body. The lead body has a tongue part 21 in which a central part 21a is formed into a curved shape and the linear member is formed so that end parts 21b and 21c are opposed to each other, the leading end arm 22 connected to one end part of the tongue part to extend, and a base end arm 23 connected to the other end part of the tongue part to extend. The distance L1 between the outsides of both end parts of the tongue part is ≥20 mm and ≤30 mm, and the leading end arm and the angle θ1 formed on the side opposite to a protruded direction in which the central part of the lead body is curved to become a protruded state by the leading end arm and the base end arm is ≥70° and ≤140°.

Description

  The present invention relates to a lead and tissue stimulation system used by being placed in a blood vessel.

  Conventionally, a tissue stimulation system is used to perform treatment by applying electrical stimulation to nerve tissue. The tissue stimulation system generally has a lead provided with an electrode, and applies electrical stimulation to nerve tissue through the electrode. Attaching the electrode directly to the patient's nerve tissue may make the procedure difficult, or may damage the nerve tissue by pressing it. For this reason, a method has been studied in which a lead is placed in a blood vessel and electrical stimulation is applied to nerve tissue in the vicinity of the blood vessel through the vessel wall of the blood vessel.

For example, the lead described in Patent Document 1 includes a lead body and a tip portion having an electrode. The lead body includes a proximal end that is connected to a pulse generator or other implantable medical device. The tip portion is arranged so that the first spiral body and the second spiral body form a so-called double spiral structure as a whole. Each spiral body is provided with the electrodes described above.
When the thus configured lead is placed in the blood vessel of the patient, the lead can be fixed to the blood vessel by the frictional engagement between the spiral body and the vessel wall of the blood vessel. The pulse generator can apply electrical stimulation to the nerve tissue via the electrodes and blood vessels.

Special table 2010-516384 gazette

  However, since the lead described in Patent Document 1 has a double helix structure at the tip, the outer diameter is large, and when the lead is introduced into the blood vessel, the blood vessel needs to be largely incised.

  The present invention has been made in view of such problems, and provides a lead having a reduced outer diameter while suppressing displacement when introduced into a blood vessel, and a tissue stimulation system including the lead. The purpose is to provide.

In order to solve the above problems, the present invention proposes the following means.
The lead of the present invention is a lead placed in a branch portion of a blood vessel, and is a lead body formed of a linear member having an insulating property, and a pair of electrodes provided to be exposed to the outside of the lead body And an electric wire portion that is provided in the lead body and is electrically connected to the electrode and extends to the base end side of the lead body, and the lead body has a shape with a curved central portion. A tongue-shaped portion formed with the linear member formed so that both ends thereof are opposed to each other, and a distal end that is connected to one end of the tongue-shaped portion and extends on the distal end side of the lead body An arm portion and a proximal arm portion that forms a proximal end side of the lead body and extends to be connected to the other end portion of the tongue-shaped portion, and between the outer sides of both ends of the tongue-shaped portion. The distance is 20 mm or more and 30 mm or less, and the distal arm portion and the proximal arm portion But wherein it is characterized in that the convex direction of the central portion of the lead body is a convex curved the angle formed on the opposite side it is less than 70 ° 140 ° or less.

  In addition, another lead of the present invention is a lead placed in a branch portion of a blood vessel, and is provided so as to be exposed to the outside from a lead body formed of a linear member having insulating properties. A pair of electrodes, and an electric wire portion provided in the lead body, electrically connected to the electrode and exposed to the proximal end side of the lead body, the lead body having a central portion Is formed in a curved shape and has a tongue-like portion on which the linear member is formed so that both end portions thereof are opposed to each other, and forms a distal end side of the lead body, and is connected to one end portion of the tongue-like portion A distal end arm portion that extends and a proximal end arm portion that forms a proximal end side of the lead body and is connected to the other end portion of the tongue-shaped portion, and has both end portions of the tongue-shaped portion The distance between the outsides is 14 mm or more and 20 mm or less. And the proximal arm portion, wherein it is characterized in that the said convex direction the central portion has a convex shape with the curvature of the lead body is the angle formed on the opposite side is less than 140 ° 90 ° or more.

In the above lead, it is more preferable that the pair of electrodes is provided on the outer surface of the one end portion of the tongue-like portion opposite to the other end portion.
Further, in the above lead, the cross section perpendicular to the axis of the lead main body in the portion where the electrode is provided has a direction perpendicular to the facing direction rather than the facing direction in which the end portions of the tongue-shaped portions face each other. It is more preferable that is set longer.
Further, in the above lead, the lead body has an arcuate body in which the linear member is formed in an arc shape at an end on the distal end side of the distal arm, and the outer diameter of the arcuate body is: More preferably, it is 10 mm or more and 20 mm or less.

Further, in the above lead, the tip arm portion is connected to the tongue-like portion and extends straightly, and the tip straight portion is connected to the opposite side of the tongue-like portion to the tip-like straight portion. A distal end curved portion that curves in a direction opposite to the convex direction with respect to the straight portion, and when viewed along the distal straight portion, the width of the distal arm portion is 10 mm or more and 20 mm or less. It is more preferable that
Further, in the above lead, the base end arm portion is connected to the tongue-like portion and extends linearly, and is connected to the base end straight portion, with respect to the base end straight portion. And a base end curved portion that curves so as to be convex on the opposite side to the convex direction, and the width of the base end arm portion is 10 mm when viewed along the base end straight portion. More preferably, it is 20 mm or less.
Further, in the above lead, it is more preferable that the base end arm portion is provided with an engaging portion formed so as to protrude from the outer surface of the base end arm portion.

In the above lead, the lead main body is connected between the tongue-shaped portion and the tip arm portion, and extends in a direction opposite to the convex direction, the tongue-shaped portion, A second straight portion connected between the base end arm portion and extending in a direction opposite to the convex direction, wherein three or more electrodes are provided, and the second straight portion It is more preferable that it is provided on the outer surface opposite to the first straight portion.
Further, in the above lead, the tip arm portion is connected to the tongue-like portion and extends straightly, and the tip straight portion is connected to the opposite side of the tongue-like portion to the tip-like straight portion. And a tip curved portion that curves so as to be convex on the opposite side to the convex direction with respect to the straight portion, and the pair of electrodes are outer surfaces on the opposite side to the convex direction in the tip curved portion. It is more preferable that the width of the tip arm portion is 6 mm or more and 10 mm or less when viewed along the tip straight portion.

Further, in the lead described above, the tip arm portion passes through the tip connection end portion connected to one end portion of the tongue-like portion, and the tip connection end portion with respect to a tip reference plane orthogonal to the convex direction. The free distal end on the opposite side is disposed on the opposite side to the convex direction, and the proximal arm part passes through the proximal connection end connected to the other end of the tongue-like part in the convex direction. It is more preferable that the base end free end on the opposite side to the base end connecting end with respect to the base end reference plane orthogonal to is disposed on the side opposite to the convex direction.
In addition, a tissue stimulation system according to the present invention includes the lead according to any one of the above, and a signal generator that is connected to a proximal end of the lead and applies electrical stimulation to the electric wire portion. .

  According to the lead and tissue stimulation system of the present invention, the outer diameter can be kept small while restraining displacement when introduced into the blood vessel.

1 is an overall view of a tissue stimulation system according to a first embodiment of the present invention. It is a side view of the lead | read | reed of the same tissue stimulation system. It is sectional drawing of cutting line A1-A1 in FIG. It is a figure explaining the state which incised the patient and formed the opening. It is a figure explaining the state which detained the lead in the branching part of the blood vessel. It is a figure which shows the state which indwelled the lead in the modification of 1st Embodiment of this invention in the branch part of the blood vessel. It is sectional drawing of cutting line A2-A2 in FIG. It is sectional drawing of the cutting line A3-A3 in FIG. It is sectional drawing of the principal part of the lead | read | reed in the modification of 1st Embodiment of this invention. It is a front view of the lead | read | reed in the modification of 1st Embodiment of this invention. It is a figure which shows the state which detained the lead in the branch part of the blood vessel. It is a front view of the lead | read | reed in the modification of 1st Embodiment of this invention. It is a figure which shows the state which detained the lead in the branch part of the blood vessel. It is a principal part enlarged view of the lead in the modification of 1st Embodiment of this invention. It is a figure which shows the state which indwelled the tissue stimulation system in the modification of 1st Embodiment of this invention in the branch part of the blood vessel. It is a figure which shows the state which indwelled the tissue stimulation system in the modification of 1st Embodiment of this invention in the branch part of the blood vessel. It is a front view of the lead | read | reed in the modification of 1st Embodiment of this invention. It is a cross-sectional view of a patient's neck. It is a figure which shows the state which detained the lead in the branch part of the blood vessel. It is a general view of the tissue stimulation system of 2nd Embodiment of this invention. It is a figure which shows the state which detained the lead | read | reed of the tissue stimulation system in the branch part of the blood vessel. It is a general view of the tissue stimulation system of 3rd Embodiment of this invention. It is a figure which shows the state which detained the lead | read | reed of the tissue stimulation system in the branch part of the blood vessel. It is a front view of the lead | read | reed in embodiment of the modification of this invention. It is a side view of the lead.

(First embodiment)
Hereinafter, a first embodiment of a tissue stimulation system according to the present invention will be described with reference to FIGS. This tissue stimulation system is a device that applies electrical stimulation to nerve tissue in the vicinity of a blood vessel through a vessel wall of the blood vessel from a lead placed at a branch portion of the blood vessel. In this example, the lead is placed at the bifurcation of the superior vena cava and the right subclavian vein.
As shown in FIG. 1, the tissue stimulation system 1 of the present embodiment includes a lead 10 of the present invention and a signal generator 40 that is connected to the proximal end of the lead 10 and applies electrical stimulation to a wire portion 30 described later. I have.

  As shown in FIGS. 1 and 2, the lead 10 includes a lead body 20 formed of a linear member having insulation and elasticity, and a pair of electrodes 25 provided to be exposed to the outside of the lead body 20. 26 and an electric wire portion 30 that is formed of an elastic material and is provided in the lead body 20 and is electrically connected to the electrodes 25 and 26.

As shown in FIG. 3, the linear member is formed of a shape memory alloy such as a nickel titanium alloy in a resin material 20A having biocompatibility and insulating properties such as silicon, polyurethane, and ETFE (polytetrafluoroethylene). What embedded the core material 20B made can be used suitably. In this example, the cross section of the lead main body 20 by a plane orthogonal to the axis is formed in a circular shape. The lead body 20 is configured so that the outer surface has an insulating property.
In the natural state shown in FIGS. 1 and 2, the lead main body 20 is formed in a curved shape in the central portion 21a and a tongue-like portion 21 in which linear members are formed so that both end portions 21b and 21c face each other. The lead arm 20 is formed on the distal end side of the lead body 20 and connected to the end 21b of the tongue-shaped portion 21 so as to extend, and the proximal end side of the lead body 20 is formed on the tongue-shaped portion 21. And a base end arm portion 23 formed so as to extend by being connected to the end portion 21c.
In the present embodiment, the tongue portion 21 is formed in an arc shape having a central angle θ1 of about 180 °. In this example, since the tongue-like portion 21 is placed in the superior vena cava, the distance L1 between the outer sides of both end portions 21b and 21c is set to 20 mm or more and 30 mm or less.

The tongue-shaped portion 21, the distal arm portion 22, and the proximal arm portion 23 are formed on the same plane.
The distal arm portion 22 and the proximal arm portion 23 are formed in a substantially linear shape. Here, a convex direction D1 in which the central portion 21a of the lead body 20 is curved and convex and a concave direction D2 in the opposite direction to the convex direction D1 are defined. The tip arm portion 22 is opposite to the tip connection end portion 22a with respect to the tip reference plane S1 passing through the tip connection end portion 22a connected to the end portion 21b of the tongue-like portion 21 and perpendicular to the convex direction D1. The tip free end 22b located on the side is disposed on the concave direction D2 side. Similarly, the proximal end arm portion 23 passes through the proximal end connection end portion 23a connected to the end portion 21c of the tongue-like portion 21 and is proximally connected to the proximal end reference plane S2 orthogonal to the convex direction D1. A proximal free end 23b located on the side opposite to the end 23a is arranged on the concave direction D2 side.
An angle θ2 formed by the distal arm portion 22 and the proximal arm portion 23 on the concave direction D2 side is set to 70 ° or more and 140 ° or less.

The electrodes 25 and 26 can be formed of a biocompatible metal such as a platinum iridium alloy. The electrodes 25 and 26 are arranged on the outer surface of the end portion 21 b of the tongue-shaped portion 21 opposite to the end portion 21 c so as to be spaced apart from each other along the axis of the lead body 20.
The electric wire portion 30 is composed of a pair of electric wires 31 (see FIG. 3 for one electric wire 31). The distal end portion of one electrical wiring 31 is electrically connected to the electrode 25, and the distal end portion of the other electrical wiring 31 is electrically connected to the electrode 26. Each electrical wiring 31 is insulated from each other, extends in the lead body 20 toward the base end side, and is exposed to the outside at the base end free end 23 b of the lead body 20.
As the electrical wiring 31, a conductive and highly durable MP35N line or 35NTL line covered with an insulating material such as ETFE can be suitably used. Note that only the MP35N line or 35NTL line may be used as the electric wiring 31, and these may be embedded in the resin material 20A.

In the present embodiment, a known marker 35 formed of a radiopaque metal or the like is embedded in the vicinity of the distal end free end portion 22b of the distal arm portion 22.
The lead 10 configured as described above has elasticity as a whole, and is configured to return to a shape before deformation without being plastically deformed when deformed from a natural state.

  The signal generator 40 includes a connector 41 that can be attached to and detached from the proximal end free end 23b of the lead body 20, and an electrical stimulation supply unit (not shown). When the signal generator 40 is activated by connecting the base end free end 23 b to the connector 41, the electrical stimulation supply unit can supply electrical stimulation by a constant current system or a constant voltage system between the pair of electrical wirings 31. .

Next, a procedure using the tissue stimulation system 1 configured as described above will be described. In the initial state, the signal generator 40 is not connected to the lead 10.
As shown in FIG. 4, generally, the internal diameter of the superior vena cava P7 is 20 mm or less, and the angle θ3 formed by the right brachiocephalic vein P5 and the left brachiocephalic vein P6 on the opposite side of the heart P8 is 90 ° or less. . The right internal jugular vein P3 and the superior vena cava P7 are accompanied by the right vagus nerve P11, and the left internal jugular vein P4 is concurrently provided with the left vagus nerve P12.

First, the operator cuts out the patient P and forms an opening P16 that communicates with the left subclavian vein P2. A cannula (not shown) is attached to the opening P16.
While holding the proximal arm portion 23 with the curved tongue-shaped portion 21 extended substantially linearly, confirming the position of the marker 35 and the wire portion 30 under the X-ray, the lead 10 is placed on the distal arm portion 22 side. To the left subclavian vein P2 through the cannula. As shown in FIG. 5, while the lead 10 is appropriately rotated around the axis to change the direction of the distal arm portion 22, the distal arm portion 22 is introduced into the right subclavian vein P1 via the right brachial vein P5 and the tongue portion. 21 is introduced into a portion branched from the right brachiocephalic vein P5 to the superior vena cava P7.

At this time, since the distance L1 between the outer sides of both end portions 21b and 21c of the tongue-shaped portion 21 is set to be equal to or larger than the inner diameter of the superior vena cava P7, the elasticity of the tongue-shaped portion 21 and the tube wall of the superior vena cava P7 The tongue 21 is securely attached to the superior vena cava P7 by the frictional force acting between the tongue 21 and the tongue 21. The angle θ2 between the distal arm portion 22 and the proximal arm portion 23 is set to be equal to or larger than the angle θ3 between the right brachiocephalic vein P5 and the left brachiocephalic vein P6. The distal arm portion 22 is pressed against the tube wall of the vein P1, and the proximal arm portion 23 is pressed against the tube walls of the left brachiocephalic vein P6 and the left subclavian vein P2. Friction force acting between the tube wall of the right brachial vein P5 and the right subclavian vein P1 and the distal arm portion 22, and between the tube wall of the left brachiocephalic vein P6 and the left subclavian vein P2 and the proximal arm portion 23 The distal arm 22 is attached to the right brachial vein P5 and the right subclavian vein P1, and the proximal arm 23 is attached to the left brachial vein P6 and the left subclavian vein P2, respectively.
The connector 41 of the signal generator 40 is connected to the proximal end free end 23b of the lead 10 located outside the body of the patient P. When the signal generator 40 is activated, the electrical stimulation supplied by the electrical stimulation supply unit is applied between the electrodes 25 and 26 via the electric wire unit 30. This electrical stimulation acts on the vagus nerve P11 through the duct wall of the superior vena cava P7.
When electrical stimulation acts on the vagus nerve P11, the heart rate of the patient P decreases.

  After applying electrical stimulation for a certain period using the tissue stimulation system 1, the signal generator 40 is removed from the lead 10. When the lead 10 is pulled out from the cannula, the tongue 21 and the arms 22 and 23 are taken out of the patient P while deforming the shape along the subclavian veins P1 and P2. The cannula is removed, the opening P16 is sutured, and the series of procedures is completed.

As described above, according to the lead 10 and the tissue stimulation system 1 of the present embodiment, the tongue 21 is attached to the superior vena cava P7, and the distal arm 22 is attached to the right brachial vein P5 and the right subclavian vein P1. By attaching the proximal arm portion 23 to the head vein P6 and the left subclavian vein P2, the lead 10 is fixed to the branch portion of the superior vena cava P7 at three points. In this way, by supporting the blood vessel over almost the entire length of the lead 10 in the axial direction, the positional deviation of the lead 10 introduced into the superior vena cava P7 can be suppressed. The lead 10 of this embodiment is formed in a substantially V shape so as to be fixed to the branch portion at three points, and does not have a double helix structure like the lead described in Patent Document 1. For this reason, the outer diameter of the lead 10 can be kept small.
Then, the signal generator 40 is connected to the lead 10, an electrical stimulus is applied between the electrodes 25 and 26 by the signal generator 40, and this electrical stimulus is applied to the vagus nerve P <b> 11, thereby causing the heart rate of the patient P. Can be adjusted.

The electrodes 25 and 26 are provided on the outer surface of the end portion 21 b of the tongue-like portion 21 on the side opposite to the end portion 21 c. For this reason, the electrodes 25 and 26 are reliably brought into contact with the tube wall of the superior vena cava P7 by the elastic force of the tongue portion 21 and the electric wire portion 30, and the electrical stimulation applied between the electrodes 25 and 26 is applied to the vagus nerve P11. It can work effectively.
In the natural state, the distal end free end portion 22b is disposed on the concave direction D2 side with respect to the distal end reference plane S1, and the proximal end free end portion 23b is disposed on the recessed direction D2 side with respect to the proximal end reference plane S2. Yes. Therefore, the arm portions 22 and 23 are not disposed on the side of the tongue-shaped portion 21 with respect to the convex direction D1, and the tongue-shaped portion 21 can be more reliably attached to the superior vena cava P7.

Since the marker 35 is provided at the distal end portion of the lead body 20, the position of the distal end portion of the lead 10 can be easily confirmed under the X-ray.
Since the lead 10 is formed in a single line without branching, the lead 10 introduced into the body of the patient P is placed outside the patient P through the opening P16 as compared with the lead described in Patent Document 1. It can be easily taken out.

In the present embodiment, the configurations of the lead 10 and the tissue stimulation system 1 can be variously modified as described below.
6 and 7, in addition to the components of the lead 10 of the first embodiment, the lead main body 20C has a linear member formed in an arc shape at the free end portion 22b of the distal end arm portion 22. In addition, the cross section orthogonal to the axis C1 of the lead body 20C at the portion where the electrodes 25 and 26 of the lead 50 are provided is formed in an approximately elliptical shape (see FIG. 8).

The central angle of the arcuate body 52 is set to 180 ° or more and less than 360 °. The outer diameter of the arcuate body 52 in the natural state is set to 10 mm or more and 20 mm or less. The arcuate body 52 is arranged such that the axis C6 of the arcuate body 52 as a whole is substantially parallel to the axis C1 of the lead body 20. In general, the inner diameter of the right brachiocephalic vein P5 is 14 mm or less, and the inner diameter of the right subclavian vein P1 is 10 mm or less.
As shown in FIG. 8, the cross section perpendicular to the axis C <b> 1 in the portion where the electrode 25 of the lead 50 is provided is perpendicular to the facing direction E from the facing direction E where the end portions 21 b and 21 c of the tongue-shaped portion 21 are opposed. The orthogonal direction F is set longer.

By providing the arc-shaped body 52 on the lead 50, the arc-shaped body 52 is disposed in the right brachiocephalic vein P5 or the right subclavian vein P1 in a reduced diameter state. Therefore, the distal arm 22 is more securely attached to the right brachial vein P5 or the right subclavian vein P1 by the frictional force acting between the tube wall of the right brachial vein P5 or the right subclavian vein P1 and the arcuate body 52. be able to.
Further, by setting the aforementioned cross section to be longer in the orthogonal direction F than in the facing direction E, the surface of the electrode 25 exposed to the outside becomes flatter. Therefore, the electrode 25 can be contacted over a wide range by the tube wall of the superior vena cava P7, that is, the contact area of the electrode 25 can be increased.
By forming the tongue-like portion 21 long in the orthogonal direction F, it is possible to prevent blood from coming into contact with the electrode 25 in contact with the tube wall of the superior vena cava P7.

In the present modification, the cross section perpendicular to the axis C1 in the portion of the lead body 20C where the electrodes 25 and 26 are provided is formed in an approximately elliptical shape. However, it is not limited to the portion where the electrodes 25 and 26 are provided, but the cross section may be formed in a substantially elliptical shape over the entire length of the lead body 20C.
Further, in the present modification, as shown in FIG. 9, the above-described cross section may be formed in a rectangular shape having a longer corner in the orthogonal direction F and rounded corners. Even if comprised in this way, there can exist an effect similar to the said modification.

A lead 60 shown in FIGS. 10 and 11 includes a tip arm portion 62 instead of the tip arm portion 22 of the lead 10 of the first embodiment.
The distal end arm portion 62 is connected to the tongue-shaped portion 21 and extends straightly at the distal end straight portion 63, and is connected to the opposite end of the distal end straight portion 63 to the tongue-shaped portion 21. And a distal end bending portion 64 that curves toward the concave direction D2.
When viewed along the distal straight portion 63, the width L3 of the distal arm portion 62 is set to 10 mm or more and 20 mm or less.

  When the lead 60 configured in this way is placed at the branch portion of the superior vena cava P7, the width L3 of the distal arm 62 is set to be equal to or larger than the inner diameter of the right brachial vein P5 or the right subclavian vein P1, so that the distal arm The part 62 pushes the tube wall of the right brachiocephalic vein P5 or the right subclavian vein P1 radially from the inside. Thus, the distal arm portion 62 is more reliably attached to the right brachial vein P5 or the right subclavian vein P1 by the frictional force acting between the tube wall of the right brachial vein P5 or the right subclavian vein P1 and the distal arm portion 62. Can be attached.

A lead 70 shown in FIGS. 12 and 13 includes a base end arm portion 72 instead of the base end arm portion 23 of the lead 60 of the modified example.
The proximal end arm portion 72 is connected to the tongue-like portion 21 and extends linearly, and the proximal-end curved portion 74 connected to the opposite side of the proximal end straight portion 73 to the tongue-like portion 21. And a straight end portion 75 connected to the proximal end curved portion 74.
The base end straight portion 73 and the straight end portion 75 are arranged in the same straight line. The proximal end curved portion 74 is curved so as to protrude toward the concave direction D <b> 2 with respect to the proximal end straight portion 73. When viewed along the base end straight portion 73, the width L4 of the base end arm portion 72 is set to 10 mm or more and 20 mm or less. In general, the inner diameter of the left brachiocephalic vein P6 is 14 mm or less, and the inner diameter of the left subclavian vein P2 is 10 mm or less.
Further, the straight end portion 75 is provided with a groove portion (engagement portion) 76 that is recessed from the outer surface over the entire circumference of the straight end portion 75. The groove 76 is provided at a position outside the body of the patient P when the tongue-shaped portion 21 of the lead 70 is placed at the branch portion of the superior vena cava P7 of the patient P.

When the lead 70 configured in this way is placed at the branch portion of the superior vena cava P7, the width L4 of the proximal arm 72 is set to be equal to or larger than the inner diameter of the left brachiocephalic vein P6 or the left subclavian vein P2. The end arm portion 72 pushes the tube wall of the left brachiocephalic vein P6 or the left subclavian vein P2 radially from the inside. Accordingly, the proximal arm 72 is more securely attached to the left brachial vein P6 or the left subclavian vein P2 by the frictional force acting between the tube wall of the left brachial vein P6 or the left subclavian vein P2 and the proximal arm 72. Can be attached to.
Further, after the tongue-like portion 21 is placed at the branch portion of the superior vena cava P7, a suture thread (not shown) is engaged with the groove portion 76 and sutured to the epidermis of the patient P. Thereby, it can control that the base end side of lead 70 shifts to patient P.

In the present modification, a plurality of groove portions 76 may be provided apart from each other in the axial direction of the straight end portion 75.
In this modification, the engaging portion is formed so as to be immersed from the outer surface of the straight end portion 75. However, as shown in FIG. 14, the engaging portion may be formed like a plate-like member 77 protruding from the outer surface of the straight end portion 75. The plate-like member 77 is formed in a so-called wing shape that is widened as it is separated from the straight end portion 75, and a pair of plate members 77 are provided with the straight end portion 75 interposed therebetween. In this example, the plate-like member 77 is formed with a through hole 77a penetrating in the thickness direction.
By using the plate-like member 77 as the engaging portion, after placing the tongue-like portion 21 at the branch portion of the superior vena cava P7, the plate-like member 77 is attached to the epidermis of the patient P with a medical tape (not shown) or the like. The lead 70 can be prevented from being displaced by being attached to the skin or by stitching the skin through the through-hole 77a and passing through the skin of the patient P.

  The lead 80 of the tissue stimulation system 2 shown in FIG. 15 is set to be longer than the lead 10 of the first embodiment so that the distal arm 22 can be placed in the right internal jugular vein P3. 25 and 26 are provided in the vicinity of the distal end free end portion 22b of the distal end arm portion 22. As described later, in order to place the distal arm 22 in the right internal jugular vein P3, the length of the distal arm 22 is preferably set to 50 mm or more and 120 mm or less.

When the tissue stimulation system 2 configured as described above is placed, the lead arm is appropriately rotated around the axis while confirming the positions of the electrodes 25 and 26 and the electric wire portion 30 (not shown) under the X-ray, and the distal arm portion The tip arm portion 22 is introduced into the right internal jugular vein P3 through the right subclavian vein P1 while changing the direction of 22.
As described above, the vagus nerve P11 is running along the right internal jugular vein P3. For this reason, by supplying an electrical stimulus between the electrodes 25 and 26 from the signal generator 40 connected to the lead 80, this stimulus can be applied to the vagus nerve P11 through the tube wall of the right internal jugular vein P3. .

Moreover, in the said modification, you may comprise so that the signal generator 43 connected to the lead 90 and the base end of the lead 90 may be provided like the tissue stimulation system 3 shown in FIG.
The lead 90 includes electrodes 27 and 28 in addition to the components of the lead 80 of the modified example. In this example, the electric wire part 30 is comprised by the four electric wiring 31 (not shown), and each electric wiring 31 is electrically connected to the electrodes 25-28. Each electric wiring 31 extends to the base end side in a state of being insulated from each other, and is exposed to the outside at the base end free end portion 23 b of the base end arm portion 23.
The connector 44 of the signal generator 43 can be attached to and detached from the proximal end free end 23b. When the connector 44 is connected to the proximal free end 23b, the electrical stimulation supply unit (not shown) built in the signal generator 43 is electrically connected between the electrodes 25 and 26 and between the electrodes 27 and 28, respectively. Can provide stimuli.

  According to the lead 90 and the tissue stimulation system 3 of the present embodiment configured as described above, electrical stimulation can be more effectively applied to the vagus nerve P11 by the electrodes 25 to 28.

A lead 100 shown in FIG. 17 includes a tip arm portion 102 instead of the tip arm portion 22 of the lead 80 of the modification.
The tip arm portion 102 has a straight tip portion 103 connected to the tongue portion 21 and extending linearly, and a tip bending portion 104 connected to the tip straight portion 103 on the opposite side of the tongue portion 21. ing.
The distal end bending portion 104 is curved so as to protrude toward the concave direction D <b> 2 with respect to the distal end straight portion 103. The electrodes 25 and 26 are provided on the outer surface of the distal end bending portion 104 on the concave direction D2 side. When viewed along the distal straight portion 103, the width L6 of the distal arm portion 102 is set to 6 mm or more and 10 mm or less.

  As shown in FIG. 18, generally, in the neck P21, the vagus nerve P11 runs along the left internal jugular vein P4 side of the right internal jugular vein P3. In general, the inner diameter of the right internal jugular vein P3 is 6 mm or less.

As shown in FIG. 19, when the tongue-like portion 21 of the lead 100 configured as described above is introduced into the branch portion of the superior vena cava P7 and the distal end side of the distal arm portion 102 is introduced into the right internal jugular vein P3, Since the width L6 of the distal arm 102 is set to be equal to or larger than the inner diameter of the right internal jugular vein P3, the right internal jugular vein is caused by the frictional force acting between the tube wall of the right internal jugular vein P3 and the distal arm 102. The distal arm portion 102 can be securely attached to P3.
Since the electrodes 25 and 26 are provided on the outer surface of the distal bending portion 104 on the concave direction D2 side, the electrodes 25 and 26 are arranged facing the vagus nerve P11 side in the right internal jugular vein P3. Therefore, the electrical stimulation applied between the electrodes 25 and 26 can be effectively applied to the vagus nerve P11 through the tube wall of the right internal jugular vein P3.

  The lead 100 may be introduced from the opening on the right subclavian vein P1 side and the distal curved portion 104 may be arranged in the left internal jugular vein P4. By introducing the lead 100 in this manner, electrical stimulation applied between the electrodes 25 and 26 can be applied to the vagus nerve P12 through the tube wall of the left internal jugular vein P4.

(Second Embodiment)
Next, a second embodiment of the present invention will be described with reference to FIGS. 20 and 21. However, the same parts as those of the above embodiment are denoted by the same reference numerals, and the description thereof will be omitted. Only differences will be described. explain.
As shown in FIG. 20, the tissue stimulation system 5 of this embodiment includes the lead 110 of the present invention and a signal generator 45 that supplies electrical stimulation to the lead 110.

The lead 110 includes a lead body 111 and two electrodes 27 and 28 instead of the lead body 20 of the lead 10 of the first embodiment.
The lead body 111 is connected between the tongue portion 21 and the distal arm portion 22 and connected between the first straight portion 112 extending in the concave direction D2 and between the tongue portion 21 and the proximal arm portion 23. And a second straight portion 113 extending in the concave direction D2.
The electrodes 25 to 28 are provided on the outer surface of the second straight part 113 opposite to the first straight part 112 along the axis of the second straight part 113.
In this example, the electric wire part 30 is comprised by the four electric wiring 31 (not shown), and each electric wiring 31 is electrically connected to the electrodes 25-28. Each electric wiring 31 extends to the base end side in a state of being insulated from each other, and is exposed to the outside at the base end free end portion 23 b of the base end arm portion 23.
The connector 44 of the signal generator 45 can be attached to and detached from the base end free end 23b. When the connector 44 is connected to the proximal free end 23b, an electrical stimulation supply unit (not shown) built in the signal generator 45 performs electrical stimulation between desired two of the electrodes 25 to 28. Can be supplied.
In the present embodiment, the outer diameter of the arcuate body 52 in the natural state is 10 mm or more and 20 mm or less.

Next, a procedure using the tissue stimulation system 5 configured as described above will be described.
First, the operator incises the patient P and forms an opening P17 communicating with the right subclavian vein P1, as shown in FIG. A cannula (not shown) is attached to the opening P17. The proximal arm portion 23 is gripped with the curved tongue-like portion 21 stretched substantially linearly, and the lead 110 is introduced from the distal arm portion 22 side through the cannula into the right subclavian vein P1.
While appropriately rotating the lead 110 around the axis to change the orientation of the distal arm portion 22, the distal arm portion 22 is introduced into the left subclavian vein P2 via the left brachiocephalic vein P6, and the tongue portion 21 and the straight portion 112, 113 is arranged at a portion branched from the right brachiocephalic vein P5 to the superior vena cava P7. At this time, the four electrodes 25 to 28 are arranged along the longitudinal direction of the superior vena cava P7.
Since the arcuate body 52 provided in the distal arm portion 22 is arranged in a reduced diameter in the left brachiocephalic vein P6 or the left subclavian vein P2, the distal arm portion is placed on the left brachial vein P6 or the left subclavian vein P2. 22 can be attached more reliably.

As described above, the vagus nerve P11 is juxtaposed to the superior vena cava P7. However, the longitudinal direction of the superior vena cava P7 is effective for applying electrical stimulation to the vagus nerve P11 through the tube wall of the superior vena cava P7. The location varies from patient to patient.
The surgeon connects the connector 44 to the proximal end free end 23b. Then, the heart rate of the patient P is measured while supplying electrical stimulation between two desired electrodes among the electrodes 25 to 28, and a pair of electrodes that can most reduce the heart rate of the patient P is selected. .

As described above, according to the lead 110 and the tissue stimulation system 5 of the present embodiment, the outer diameter can be suppressed small while suppressing the displacement when introduced into the blood vessel. Furthermore, electrical stimulation can be effectively applied according to the state of the vagus nerve P11 of the patient P by selecting an appropriate pair of electrodes from the four electrodes 25-28.
In the present embodiment, the four electrodes 25 to 28 are provided. However, the number of electrodes provided on the lead 110 is not limited as long as it is three or more.

(Third embodiment)
Next, a third embodiment of the present invention will be described with reference to FIGS. 22 and 23. The same reference numerals are given to the same parts as those in the above-described embodiment, and the description thereof will be omitted. Only differences will be described. explain.
As shown in FIG. 22, the tissue stimulation system 6 of the present embodiment includes the lead 120 of the present invention and the signal generator 40 described above.
In the lead 120, the distance L8 between the outer sides of both end portions 21b and 21c of the tongue-shaped portion 21 and the distal arm portion 22 and the proximal arm portion 23 are in the concave direction D2 side with respect to the lead 10 of the first embodiment. The angle θ5 and the positions where the electrodes 25 and 26 are provided are different.
In this example, the distance L8 is set to 14 mm or more and 20 mm or less, and the angle θ5 is set to 90 ° or more and 140 ° or less. The electrodes 25 and 26 are provided on the outer surface of the distal arm 22 on the side away from the proximal arm 23.

Next, a procedure using the tissue stimulation system 6 configured as described above will be described.
In general, the angle θ6 (see FIG. 4) formed by the right subclavian vein P1 and the right internal jugular vein P3 on the opposite side of the heart P8 is 90 ° or less.
First, as shown in FIG. 23, the operator forms an opening P17 that communicates with the right subclavian vein P1, holds the proximal arm 23 in a state in which the tongue 21 extends substantially linearly, The lead 120 is introduced into the right subclavian vein P1 from the distal arm portion 22 side.
The lead arm 22 is introduced into the right internal jugular vein P3 while the lead 120 is appropriately rotated around the axis to change the orientation of the distal arm portion 22, and the tongue 21 is disposed in the right brachial vein P5. That is, the lead 120 is placed at the branch portion between the right subclavian vein P1 and the right internal jugular vein P3.

At this time, the distance L8 between the outer sides of both end portions 21b and 21c of the tongue-like portion 21 is set to be equal to or larger than the inner diameter of the right brachiocephalic vein P5, so that the elasticity of the tongue-like portion 21 and the tube of the right subclavian vein P1 By the frictional force acting between the wall and the tongue portion 21, the tongue portion 21 is securely attached to the right brachiocephalic vein P5. Since the angle θ5 between the distal arm portion 22 and the proximal arm portion 23 is set to an angle θ6 or more between the right subclavian vein P1 and the right internal jugular vein P3, the elastic force of the lead 120 causes the right subclavian vein P1 to The proximal arm portion 23 is pressed against the tube wall, and the distal arm portion 22 is pressed against the tube wall of the right internal jugular vein P3. The proximal arm of the right subclavian vein P1 is caused by frictional force acting between the tube wall of the right subclavian vein P1 and the proximal arm 23 and between the tube wall of the right internal jugular vein P3 and the distal arm 22. The distal end arm portion 22 is attached to the right internal jugular vein P3.
Since the electrodes 25 and 26 are disposed on the vagus nerve P11 side in the right internal jugular vein P3, electrical stimulation applied between the electrodes 25 and 26 can be effectively applied to the vagus nerve P11.

  As described above, according to the lead 120 and the tissue stimulation system 6 of the present embodiment, the outer diameter can be suppressed small while suppressing the displacement when introduced into the blood vessel. Furthermore, the lead 120 can be reliably placed at the branch portion between the right subclavian vein P1 and the right internal jugular vein P3.

The first to third embodiments of the present invention have been described in detail with reference to the drawings. However, the specific configuration is not limited to this embodiment, and the configuration does not depart from the gist of the present invention. Changes are also included. Furthermore, it goes without saying that the configurations shown in the embodiments can be used in appropriate combinations.
For example, in the first to third embodiments, the tongue portion 21, the distal arm portion, and the proximal arm portion are formed on the same plane. However, like the lead 130 shown in FIGS. 24 and 25, the tongue portion 21, the distal arm portion 22, and the proximal arm portion 23 do not have to be formed on the same plane. In this example, the distal arm portion 22 and the proximal arm portion 23 of the lead 130 extend so as to intersect with the arrangement plane S4 on which the tongue-like portion 21 is arranged.

In the first to third embodiments, when the electric wire portion 30 is provided so as to extend to the leading end portion of the lead, the marker 35 may not be provided on the lead.
In the first to third embodiments, the vagus nerve is stimulated by placing the lead at the branch of the superior vena cava P7 or the right internal jugular vein P3. However, the branch of the blood vessel where the lead is placed and the nerve that acts on the electrical stimulation are not limited to this. For example, the lead is placed at the branch of the popliteal vein to electrically stimulate the nerve such as the radial nerve. Can act.

In the lead 10 of the first embodiment, the distal end free end 22b is arranged on the convex direction D1 side with respect to the distal end reference plane S1, and the proximal free end 23b is projected with respect to the proximal reference plane S2. It may be arranged on the direction D1 side. This is because even with this configuration, the lead 10 can be elastically deformed into a desired shape when the lead 10 is introduced into the blood vessel.
In the first to third embodiments, the signal generator is provided with a connector, and the end of the lead body can be attached to and detached from the connector. However, this connector may be provided only at the end of the lead body so that the connector of the lead body and the signal generator can be attached or detached, or the connector is provided at both the end of the lead body and the signal generator. May be configured to be removable.

In the procedure using the tissue stimulation system according to the first to third embodiments, after the lead is introduced into the branch of the blood vessel and the signal generator is connected to the lead, the lead and the signal generator are connected to the chest. It may be placed in the body of the patient P such as under the skin. By performing such a procedure, the tissue stimulation system 1 can continue to apply electrical stimulation to the patient P for a longer period of time.
In addition to the electrodes 25 and 26, detection electrodes may be arranged on the lead body so as to be exposed to the outside. The detection electrode is connected to an electrocardiogram measuring device or the like via an electrical wiring. By comprising in this way, the state of the patient P which applied the electrical stimulus by the electrodes 25 and 26 can be measured with a detection electrode.

  Further, in the procedure using the tissue stimulation system, when the tongue portion of the lead body is introduced into the superior vena cava P7, the introduction position of the lead into the blood vessel is the right subclavian vein P1 or the left subclavian vein P2. . However, the introduction position of the lead into the blood vessel is not limited to this, and the lead may be introduced into the blood vessel from the right internal jugular vein or the left internal jugular vein. Even if the lead is introduced in this way, the same effect as the above-described procedure can be obtained.

1, 2, 3, 5, 6 Tissue stimulation system 10, 50, 60, 70, 80, 90, 100, 110, 120, 130 Lead 20, 20C, 111 Lead body 21 Tongue 21a Center 21b, 21c End Part 22, 62, 102 Tip arm part 23, 72 Base arm part 25, 26, 27, 28 Electrode 30 Electric wire part 40, 43, 45 Signal generator 52 Arc-shaped body 63, 103 Tip straight part 64, 104 Tip curve Part 73 Base end straight part 74 Base end curved part 76 Groove part (engagement part)
77 Plate member (engagement part)
112 1st straight part 113 2nd straight part D1 Convex direction E Opposite direction L1 Distance

Claims (12)

A lead indwelled at a bifurcation of a blood vessel,
A lead body formed of a linear member having insulating properties;
A pair of electrodes provided on the lead body so as to be exposed to the outside;
An electric wire portion provided in the lead body, electrically connected to the electrode and extending to the proximal end side of the lead body and exposed,
The lead body is
A tongue-like portion in which the linear member is formed so that the center portion is formed in a curved shape and both end portions are opposed to each other;
A distal arm portion that forms the distal end side of the lead body and extends while being connected to one end portion of the tongue-shaped portion;
A proximal end of the lead body, and a proximal arm extending to be connected to the other end of the tongue,
The distance between the outer sides of both ends of the tongue-shaped portion is 20 mm or more and 30 mm or less,
An angle formed between the distal arm portion and the proximal arm portion on a side opposite to a convex direction in which the central portion of the lead body is curved and convex is 70 ° or more and 140 ° or less. Lead. A lead indwelled at a bifurcation of a blood vessel,
A lead body formed of a linear member having insulating properties;
A pair of electrodes provided on the lead body so as to be exposed to the outside;
An electric wire portion provided in the lead body, electrically connected to the electrode and extending to the proximal end side of the lead body and exposed,
The lead body is
A tongue-like portion in which the linear member is formed so that the center portion is formed in a curved shape and both end portions are opposed to each other;
A distal arm portion that forms the distal end side of the lead body and extends while being connected to one end portion of the tongue-shaped portion;
A proximal end of the lead body, and a proximal arm extending to be connected to the other end of the tongue,
The distance between the outer sides of both ends of the tongue is 14 mm or more and 20 mm or less,
An angle formed between the distal arm portion and the proximal arm portion on a side opposite to a convex direction in which the central portion of the lead body is curved and convex is 90 ° or more and 140 ° or less. Lead.   3. The lead according to claim 1, wherein the pair of electrodes are provided on an outer surface of one end portion of the tongue-like portion opposite to the other end portion.   The cross section perpendicular to the axis of the lead body in the portion where the electrode is provided is set to be longer in the direction perpendicular to the facing direction than in the facing direction in which the ends of the tongue-shaped parts face each other. The lead according to claim 3, wherein the lead is provided. The lead body has an arcuate body in which the linear member is formed in an arc shape at an end portion on a distal end side of the distal arm portion,
The lead according to claim 1, wherein an outer diameter of the isolated body is 10 mm or more and 20 mm or less. The tip arm is
A straight end portion connected to the tongue-like portion and extending linearly;
A tip bending portion that is connected to the opposite side of the tongue-like portion in the tip straight portion and curves to the opposite side of the convex direction with respect to the tip straight portion;
Have
The lead according to claim 1, wherein the width of the tip arm portion is 10 mm or more and 20 mm or less when viewed along the tip straight portion. The proximal arm is
A proximal straight portion connected to the tongue and extending linearly;
A proximal curved portion that is connected to the proximal straight portion and curves so as to protrude toward the opposite side of the convex direction with respect to the proximal straight portion;
Have
The lead according to claim 1, wherein the width of the base end arm portion is 10 mm or more and 20 mm or less when viewed along the base end straight portion.   The lead according to claim 1, wherein the proximal end arm portion is provided with an engaging portion formed so as to protrude from an outer surface of the proximal end arm portion. The lead body is
A first straight portion connected between the tongue portion and the tip arm portion and extending in a direction opposite to the convex direction;
A second straight portion connected between the tongue portion and the proximal arm portion and extending in a direction opposite to the convex direction;
The lead according to claim 1, wherein three or more electrodes are provided and provided on an outer surface of the second straight portion opposite to the first straight portion. The tip arm is
A straight end portion connected to the tongue-like portion and extending linearly;
A tip bending portion that is connected to the opposite side of the tongue-like portion in the tip straight portion and curves so as to be convex to the opposite side of the convex direction with respect to the tip straight portion;
Have
The pair of electrodes are provided on an outer surface opposite to the convex direction in the tip bending portion,
2. The lead according to claim 1, wherein when viewed along the distal straight portion, the width of the distal arm portion is 6 mm or more and 10 mm or less. The tip arm portion passes through a tip connection end connected to one end of the tongue-like portion, and a tip free end opposite to the tip connection end with respect to a tip reference plane orthogonal to the convex direction Part is arranged on the opposite side to the convex direction,
The base end arm portion is opposite to the base end connection end portion with respect to a base end reference plane that passes through the base end connection end portion connected to the other end portion of the tongue-like portion and is orthogonal to the convex direction. The lead according to claim 1, wherein a base end free end of the lead is disposed on a side opposite to the convex direction. The lead according to claim 1 or 2,
A signal generator connected to the proximal end of the lead and applying electrical stimulation to the wire portion;
A tissue stimulation system comprising: