JP2012024281A - Electrode lead assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To make the outer surface of an electrode lead be remarkably hard to be abraded even when an installation operation using an introducer kit is performed in an electrode lead assembly.SOLUTION: In the constitution, the electrode lead assembly 1 includes: the electrode lead 2 which has a linear lead part 4 prepared by insulation coating of conductors 4a and 4b, an electrode part 3 connected electrically with the conductors 4a and 4b on one end side of the lead part 4 and a connector part 5 connected electrically with the conductors 4a and 4b on the other end side of the lead part 4; and a protective sheath 6 which has a hemostasis valve 6c engaged with the electrode lead 2 slidably along the lead part 4 in the longitudinal direction, and a tubular part 6a provided in a shape of jutting out radially outside the outer shape of the electrode part 3, on the side of the outer periphery of the hemostasis valve 6c.

Description

  The present invention relates to an electrode lead assembly.

Conventionally, for example, a cardiac pacemaker, an implantable defibrillator, a nerve stimulator, a pain relieving device, an epilepsy treatment device, a muscle stimulator, etc., directly or indirectly for electrical stimulation to living tissue such as heart, nerve tissue, muscle, etc. There is known an apparatus for performing treatment of living tissue by applying to the above.
These devices have a stimulus generator that has an internal power source and produces electrical stimuli, and is accompanied by an electrode lead that can be implanted in the body when in use.
Such an electrode lead includes an electrical connector for electrically connecting to a stimulus generator and at least one electrode unit for applying electrical stimulation to the biological tissue or detecting electrical excitation generated in the biological tissue. Connector portion) and a lead body (lead portion) for transmitting electrical stimulation between the electrode portion and the stimulus generator.
For example, many electrode leads for pacemakers are placed in contact with the inner wall of the coronary vein of the heart or the inner wall of the atrium or ventricle. In this case, in order to install the electrode lead on the heart, an introducer comprising a guide wire, a dilator, a sheath, etc. is provided from the patient's body surface side, for example, by providing an opening that punctures the subclavian vein and reaches the inside of the vein. Using the kit, surgery is performed by a technique that secures a passage to a desired electrode installation position.
Electrode leads installed in coronary veins, or in the atria and ventricles are required to have minimal thrombus generation due to contact with blood and fibrosis of living tissue in contact with the electrode leads.
For this reason, a resin material with excellent blood compatibility, such as polyurethane resin, is used for the insulation coating of the lead part of the electrode lead, and a drug that suppresses thrombus formation such as heparin is administered as needed during implantation. Often.
For example, Patent Document 1 includes a lead extending from a proximal end to a distal end, a cardiac electrode disposed along the lead, and a coating coupled to at least a portion of the electrode; A cardiac lead is described in which the coating comprises at least one of sulfonated polytetrafluoroethylene, poly (3,4-ethylenedioxythiophene) poly (styrene sulfonate), polypyrrole polystyrene sulfonate.
Patent Document 1 describes that effects such as anti-inflammation, antithrombosis, and immunosuppression can be obtained by applying a coating made of a drug and a hydrophilic polymer to the electrode lead surface.

Special table 2009-531140 gazette

However, the conventional electrode lead as described above has the following problems.
In order to introduce the electrode lead into the blood vessel or the heart, a technique using the above introducer kit is employed.
In this technique, a guide wire is inserted from the opening of the blood vessel wall by puncture to secure a route to the target electrode installation position, and then the opening of the blood vessel wall is passed through the guide wire through the dilator and sheath. Insert while magnifying with a lator. Then, the dilator is removed while leaving an elongated tubular sheath to secure a path from the body surface to the electrode installation position. Next, the electrode lead is inserted from the opening outside the body of the sheath, the electrode is placed at a desired site, and then the sheath is removed.
During the insertion operation using such an introducer kit, the outer surface of the electrode lead scrapes the inner wall of the sheath. For this reason, minute scratches are formed on the outer surface of the electrode lead.
In particular, since the introducer inserted into the blood vessel of a lying patient is often bent rather than straight, the outer surface of the electrode lead that passes through the bent portion is more strongly rubbed. In addition, since a rubber hemostasis valve is provided inside the sheath to prevent blood from leaking from the blood vessel, the surface of the electrode lead inserted into the sheath is strongly scratched even when passing through the hemostasis valve. Is done.
In this experiment, the outer surface of the electrode lead on which minute scratches are formed can form more thrombus than an intact, smooth surface even if the material is a polyurethane resin with excellent blood compatibility. Has been confirmed. For this reason, there is a problem that the blood compatibility inherent in the material is impaired.
In particular, the tip of the electrode lead has an electrode for applying an electric pulse or receiving an electric signal from a living body, a projection shape for localizing in the living body, etc. Strong stimulation to the living body. For this reason, the tip portion of the electrode lead is a site where inflammation, fibrosis, thrombus, etc. of the contacted tissue is likely to occur, and is also a site that is most strongly scratched when passing through the sheath.
Therefore, the electrode lead has a problem that fibrosis and thrombus are likely to occur due to scratches caused by scratching when passing through the sheath.
In order to reduce such abrasion, it is conceivable to coat the electrode lead as in Patent Document 1, but it is inevitable that the electrode lead scratches the sheath. there is a possibility. When the coating is peeled off, there is a problem that minute scratches are generated on the outer surface of the electrode lead to generate fibrosis or a thrombus, or the effect of the drug contained in the coating is reduced.

  The present invention has been made in view of the above problems, and provides an electrode lead assembly in which the outer surface of the electrode lead is much less likely to be scratched even when installation work using an introducer kit is performed. For the purpose.

  In order to solve the above-described problems, an electrode lead assembly according to the present invention includes a linear lead portion in which a conductive wire is insulated, an electrode portion electrically connected to the conductive wire on one end side of the lead portion, and the An electrode lead having a connector portion electrically connected to the lead wire on the other end side of the lead portion, a locking portion that is slidably locked to the electrode lead along the longitudinal direction of the lead portion, and And an electrode portion protection member having an outer shape regulating portion provided in a shape projecting radially outward from the outer shape of the electrode portion on the outer peripheral side of the locking portion.

  In the electrode lead assembly according to the present invention, the outer shape restricting portion may have an opening that discharges the electrode portion to the outside, and is provided in a cylindrical shape that covers at least a part of the electrode portion from the outer peripheral side. preferable.

  In the electrode lead assembly of the present invention, it is preferable that the outer shape restricting portion is provided in a cylindrical shape that covers the entire electrode portion from the outer peripheral side.

  Further, in the electrode lead assembly of the present invention, the electrode part is folded so as to expand outside when released from the opening, and the outer shape restricting part is at least one of the folded electrode parts. It is preferable that the tube is provided in a cylindrical shape that partially covers from the outer peripheral side.

  According to the electrode lead assembly of the present invention, since the electrode portion protection member having the outer shape regulating portion provided in a shape projecting radially outward from the outer shape of the electrode portion is locked to the electrode lead, the introducer Even if the installation work using the kit is performed, there is an effect that the outer surface of the electrode lead is much less easily scratched.

1A is a schematic perspective partial sectional view showing a configuration of an electrode lead assembly according to a first embodiment of the present invention, and FIG. It is a typical front view showing an example of an introducer kit which introduces the electrode lead assembly concerning a 1st embodiment of the present invention into the living body. It is process explanatory drawing which shows the assembly process of the electrode lead assembly which concerns on the 1st Embodiment of this invention. It is process explanatory drawing explaining the installation method which installs the electrode lead assembly which concerns on the 1st Embodiment of this invention in a patient's body. It is process explanatory drawing explaining the process following FIG. 4 of the installation method which installs the electrode lead assembly which concerns on the 1st Embodiment of this invention in a patient's body. It is the typical perspective fragmentary sectional view which shows the structure of the electrode lead assembly which concerns on the modification of the 1st Embodiment of this invention, and the elements on larger scale which show the shape at the time of the expansion | deployment of an electrode part. It is a typical perspective fragmentary sectional view showing the composition of the electrode lead assembly concerning a 2nd embodiment of the present invention, and the perspective fragmentary sectional view of an electrode part protection member. It is the typical front view which shows an example of the introducer kit which introduces the electrode lead assembly which concerns on the 2nd Embodiment of this invention into a biological body, and the perspective fragmentary sectional view which shows the detailed structure of the C section. It is a typical perspective fragmentary sectional view showing the composition of the electrode lead assembly concerning a 3rd embodiment of the present invention, and the perspective fragmentary sectional view of an electrode part protection member. It is typical sectional drawing explaining the effect | action of the electrode part protection member in the 3rd Embodiment of this invention.

  Embodiments of the present invention will be described below with reference to the accompanying drawings. In all the drawings, even if the embodiments are different, the same or corresponding members are denoted by the same reference numerals, and common description is omitted.

[First Embodiment]
An electrode lead assembly according to a first embodiment of the present invention will be described.
FIG. 1A is a schematic perspective partial cross-sectional view showing the configuration of the electrode lead assembly according to the first embodiment of the present invention. FIG.1 (b) is a side view of the A view in Fig.1 (a). FIG. 2 is a schematic front view showing an example of an introducer kit for introducing the electrode lead assembly according to the first embodiment of the present invention into a living body. 3A, 3B, and 3C are process explanatory views showing an assembly process of the electrode lead assembly according to the first embodiment of the present invention.

The electrode lead assembly 1 of this embodiment shown in FIG. 1A is installed in a patient's body to apply electrical stimulation to the living tissue at the installation site, or to detect electrical excitation generated in the living tissue. It is used by being electrically connected to a stimulus generator (not shown).
When the electrode lead assembly 1 is installed in the patient's body, an introducer kit 100 (see FIG. 2) described later is used.
Examples of the stimulation generator to which the electrode lead assembly 1 is electrically connected include a cardiac pacemaker, an implantable defibrillator, a nerve stimulation device, a pain relief device, an epilepsy treatment device, and a muscle stimulation device. Can do.

First, the configuration of the introducer kit 100 will be described with reference to FIG.
The introducer kit 100 can employ the same configuration as that used to introduce a conventional electrode lead into a patient's body.
The introducer kit 100 includes an injection needle 102 that punctures a blood vessel into which the electrode lead assembly 1 is inserted, a syringe barrel 101 that is detachably provided on the injection needle 102, and a guide wire 105 that is inserted into the blood vessel through the injection needle 102. A dilator 104 that secures an insertion path along the guide wire 105 disposed in the blood vessel, a cylindrical tubular introducer sheath 103 installed in the blood vessel in a state of being fitted around the dilator 104, and an introducer And a slitter 106 that tears the introducer sheath 103 along the axial direction when the sheath 103 is removed from the body.
The introducer sheath 103, the tip side opening 103b of the inside diameter D ₀ is provided at the distal end side of the insertion direction into the body, the base end side in the insertion direction, the proximal opening 103a incorporating a hemostasis valve (not shown) Is provided.
In addition, a rod-shaped grasping portion 103c for an operator to grasp the introducer sheath 103 outside the body is provided on the outer peripheral portion of the proximal end side opening 103a.

  As shown in FIG. 1, the schematic configuration of the electrode lead assembly 1 includes an electrode lead 2 and a protective sheath 6 (electrode part protecting member).

The electrode lead 2 includes a linear lead portion 4 formed by insulatingly covering a plurality of conductive wires 4a and 4b, a first electrode 3a electrically connected to the conductive wires 4a and 4b on one end side of the lead portion 4, An electrode part 3 having two electrodes 3b and a connector part 5 electrically connected to the lead wire at the other end of the lead part 4 and thereby electrically connected to the first electrode 3a and the second electrode 3b, respectively. Prepare.
The conductive wires 4a and 4b are provided to have substantially the same length as the lead portion 4 between the electrode portion 3 and the connector portion 5, but only a part is shown in FIG. Yes.
Below, if there is no possibility of misunderstanding, in the lead portion 4, the end portion on the side where the electrode portion 3 is provided may be referred to as a distal end portion, and the end portion on the side where the connector portion 5 is provided may be referred to as a proximal end portion. .

The cross section of the lead portion 4 of the present embodiment is a circular shape having an outer diameter d ₀ , and a stylet insertion hole 4 c through which the stylet is inserted is formed at the center portion from the proximal end portion of the lead portion 4 to the vicinity of the distal end portion. Is provided. The stylet insertion hole 4c is also passed through the inside of the lead part 4 at the position where the connector part 5 is provided. In FIG. 1, the stylet insertion hole 4 c is illustrated only on the base end portion side, and the intermediate portion and the distal end portion side are not illustrated for ease of viewing.
The covering material of the lead portion 4 is made of, for example, a resin material that is excellent in blood compatibility, such as polyurethane resin, and can obtain good sliding characteristics in the blood vessel. The surface of the lead part 4 may be provided with a hydrophilic polymer for enhancing lubricity, or a coating for the purpose of anti-inflammation, anti-fibrosis, anti-thrombosis, immunosuppression and the like.

The first electrode 3a and the second electrode 3b of the electrode unit 3 are bipolar types for applying an electrical stimulus to a living tissue or detecting an electrical excitement occurring in the living tissue when placed in a living body. The electrode is comprised.
The first electrode 3 a is provided so as to be exposed at the distal end portion of the lead portion 4.
The second electrode 3 b is provided at a position spaced a certain distance from the first electrode 3 a to the base end side of the lead portion 4.
The shape of the exposed portion of the second electrode 3 b is an annular shape that goes around the outer peripheral portion of the lead portion 4. The outer diameter of the second electrode 3 b is substantially the same as the outer diameter of the lead portion 4.
Moreover, in the electrode part 3, between the 1st electrode 3a and the 2nd electrode 3b, two or more tines 3c which are protrusion parts for latching the electrode part 3 to the unevenness | corrugation on the surface of a biological tissue are provided. In the present embodiment, the tines 3c have a protruding shape having an inclination from the outer peripheral surface of the lead portion 4 toward the radially outer side as going from the first electrode 3a side of the lead portion 4 to the second electrode 3b side. The circumferential direction of 4 is projected radially at a position that divides it into four equal parts.
As shown in FIG. 1B, each of the tines 3c has the same amount of protrusion, and therefore, the tip in the protruding direction of each of the tines 3c has a diameter d _{1 that} is coaxial with the lead portion 4 (where d ₁ > d ₀ ) Is inscribed in the virtual cylinder.
Hereinafter, it referred to the diameter d ₁ of the circumscribed cylinder of such Taindo 3c to the outer diameter of Taindo 3c.
In the present embodiment, since the outer diameter of the tined 3c is larger than the outer diameter of the first electrode 3a and the second electrode 3b, the outer diameter of the tinted 3c defines the maximum outer diameter of the electrode portion 3. Yes. For this reason, it may be referred to as the maximum outer diameter of the electrode portion 3.

  The connector part 5 is a terminal part for electrically connecting the first electrode 3a and the second electrode 3b of the electrode lead 2 to the stimulus generator, and has a shape corresponding to the input / output terminal of the stimulus generator. For example, shapes such as an IS-1 connector (ISO 5841-3) and a DF-1 connector (ISO 11318: 2002) can be adopted as necessary.

The protective sheath 6 protects the outer periphery of the electrode portion 3 and the lead portion 4 so that the surfaces of the electrode portion 3 and the lead portion 4 do not rub against the introducer kit 100 when the electrode lead 2 is inserted through the introducer kit 100. It is a member.
The protective sheath 6 includes a cylindrical portion 6 a (outer shape restricting portion) provided in a cylindrical shape that accommodates part of the electrode portion 3 and the lead portion 4.
One end of the cylindrical portion 6a is opened as the inner diameter D ₁ of the front end opening 6b (opening). A rod-shaped gripping portion 6d protruding in the radial direction is provided on the outer peripheral portion of the other end of the cylindrical portion 6a, and a hemostasis valve 6c (locking portion) is provided on the inner peripheral portion of the other end of the cylindrical portion 6a. It has been.

The cross-sectional shape of the cylindrical portion 6a is an annular shape composed of concentric circles having an inner diameter D ₁ and an outer diameter D ₂ . The inner diameter D ₁ is set to be larger than the maximum outer diameter d ₁ of the electrode part 3 in order to accommodate a part of the electrode part 3 and the lead part 4.
Outer diameter _{D 2} is set smaller in diameter than the inner diameter _{D 0} of the introducer sheath 103 (see FIG. 2).
Further, the length of the tubular portion 6 a is set to be longer than the introducer sheath 103 and longer than the lead portion 4 of the electrode lead 2.
In this embodiment, the cylindrical portion 6a and the gripping portion 6d are made of a resin material that can be introduced into the living body, like the introducer sheath 103, for example, polyamide resin, polyamide-based elastomer, FEP resin (tetrafluoroethylene / hexafluoro). Propylene), ETFE resin (tetrafluoroethylene / ethylene copolymer), polypropylene resin, polyurethane resin, or the like. Further, the thickness and shape of the cylindrical portion 6 a and the gripping portion 6 d can be cut along the axial direction using the slitter 106.

Since the cylindrical portion 6a is inserted into the introducer sheath 103 disposed in the blood vessel and used, it is immersed in blood but does not directly contact the blood vessel wall. The grip 6d is disposed outside the proximal end opening 103a of the introducer sheath 103 that extends outside the patient's body.
For this reason, the material and shape of the protective sheath 6 do not have to be a material or shape that takes into consideration contact with the living tissue and abrasion. Therefore, the material and shape of the protective sheath 6 may be different from the material and shape of the introducer sheath 103 in consideration of contact with the living tissue and abrasion.
Moreover, since the cylindrical part 6a is inserted and used inside the introducer sheath 103, it can be guided and moved along the inner wall of the introducer sheath 103. For this reason, the cylindrical part 6a may be more flexible than the introducer sheath 103, or may be more flexible.
When the electrode lead assembly 1 is inserted into the body through the introducer sheath 103 through the introducer sheath 103, the tubular portion 6 a is broken by the pressing force received in the radial direction from the electrode portion 3 or rubs against the inner wall of the introducer sheath 103. It only needs to be strong enough not to open holes.

The hemostasis valve 6c is in close contact with the outer peripheral portion of the lead portion 4 so as to be slidable in the axial direction, and maintains liquid tightness between the inside and the outside of the cylindrical portion 6a. It consists of an elastic member.
Further, the opening of the hemostasis valve 6c is provided substantially at the center of the cylindrical portion 6a, whereby the lead portion 4 is held at the approximate center position of the cylindrical portion 6a in the vicinity of the hemostasis valve 6c.

In the present embodiment, the hemostasis valve 6 c constitutes a locking portion that is slidably locked to the electrode lead 2 along the longitudinal direction (axial direction) of the lead portion 4 in the protective sheath 6.
Moreover, the cylindrical part 6a comprises the external shape control part provided in the shape which protrudes in the radial direction outer side from the external shape of the electrode part 3 in the outer peripheral side of the hemostatic valve 6c which is a latching part.
Moreover, the cylindrical part 6a is an example at the time of being provided in the cylinder shape which covers the whole electrode part 3 from the outer peripheral side.

Next, a method for assembling such an electrode lead assembly 1 will be described.
FIGS. 3A, 3B, and 3C are process explanatory views respectively showing the assembly process of the electrode lead assembly according to the first embodiment of the present invention.

In order to assemble the electrode lead assembly 1, as shown in FIG. 3A, a lead portion 4, a protective sheath 6, and a connector portion 5 in which the electrode portion 3 is formed on the distal end side are prepared.
The length of the lead part 4 and the protective sheath 6 is set to a necessary length according to the position in the body where the electrode part 3 is installed. Axial length of the electrode unit 3, i.e., the length from the tip of the first electrode 3a to the second electrode 3b and the length W _1.

First, the lead portion 4 on which the electrode portion 3 is formed is inserted into the distal end opening 6b of the protective sheath 6 from the end portion on the opposite side from where the electrode portion 3 is formed.
Since this insertion operation is performed in a state where the protective sheath 6 is outside the body, the insertion is performed in a state where the cylindrical portion 6a is straightly extended as illustrated. For this reason, if the lead part 4 is positioned so as to be positioned at the center of the cylindrical part 6a and is inserted straight, it is difficult for rubbing to occur.
Compared with the electrode part 3, the lead part 4 covered with a resin material having a smaller diameter and flexibility has less abrasion resistance even if it rubs against the cylindrical part 6a, so that scratches due to abrasion occur. Hateful.
However, when inserting the lead portion 4, the friction between the lead portion 4 and the inner peripheral surface of the tubular portion 6 a should be minimized, and the lead portion 4 should be slowly inserted so that even if the rubbing occurs, the rubbing does not cause scratches. It is preferable to go.
Although not shown in FIG. 3A, since the stylet insertion hole 4c (see FIG. 1) is provided in the lead portion 4, a straight wire may be inserted into the stylet insertion hole 4c. . Thereby, even if the lead part 4 is flexible and the shape is unstable, it becomes easy to maintain a straight posture.

  Then, the end portion of the inserted lead portion 4 is passed through the hemostasis valve 6 c and a part of the lead portion 4 is extended to the outside of the protective sheath 6. In this state, the electrode part 3 is positioned outside the protective sheath 6. When the stylet is inserted, pull out the stylet.

Next, as shown in FIG. 3B, the connector portion 5 is connected to the end portion of the lead portion 4 extending from the protective sheath 6. Thereby, the electrode lead 2 in a state where the proximal end side of the lead portion 4 is inserted through the hemostasis valve 6c is formed.
Next, as shown in FIG. 3C, the proximal end side of the lead portion 4 to which the connector portion 5 is connected is pulled, and the electrode portion 3 is inserted from the distal end opening 6b side. At this time, in the vicinity of the tip opening 6b, the electrode portion 3 may be inserted in a state of being aligned with the tip opening 6b by an appropriate holding jig or the like. Thereby, rubbing between the electrode part 3 and the cylindrical part 6a can be reduced.
When the tip portion of the electrode portion 3 moves to the inside of the tubular portion 6a from the tip opening 6b, the pulling of the lead portion 4 is stopped.
In this way, the electrode lead assembly 1 can be assembled in a state where the electrode portion 3 is accommodated in the cylindrical portion 6a in the vicinity of the tip opening 6b. In this assembled state, the lead portion 4 is inserted through the hemostasis valve 6c and is in close contact with the liquid tightness. For this reason, the protective sheath 6 is in a state of being locked to the lead portion 4 via the hemostasis valve 6c. For this reason, the position of the electrode lead 2 in the axial direction with respect to the protective sheath 6 is stable.
According to such an electrode lead assembly 1, the electrode part 3 and most of the lead parts 4 are covered and protected by the cylindrical part 6a.

According to this assembly method, the electrode portions 3, only to only the relative movement distance inner peripheral surface having a length of about W ₁ of the electrode unit 3 with respect to the cylindrical portion 6a, the electrode unit 3 in the protective sheath 6 Can be accommodated. For this reason, compared with the case where the electrode part 3 is inserted from the hemostasis valve 6 c side and accommodated in the protective sheath 6, the friction between the electrode part 3 and the protective sheath 6 is reliably reduced by the short relative movement distance. can do.
That is, the electrode part 3 can be accommodated in the cylindrical part 6a in a state in which micro scratches due to abrasion with the protective sheath 6 hardly occur on the surface thereof.

  Next, the operation when the electrode lead assembly 1 is installed in the body will be described together with the method for installing the electrode lead assembly 1. 4 (a), (b), (c), (d), and (e) are steps for explaining an installation method for installing the electrode lead assembly according to the first embodiment of the present invention in a patient's body. It is explanatory drawing. FIGS. 5A and 5B are process explanatory views for explaining processes subsequent to FIG.

Hereinafter, as an example, a case where the electrode unit 3 is grounded in the heart of the patient P by the subclavian vein puncture method will be described.
First, as shown in FIG. 4A, an appropriate entry site is determined in a region B in the vicinity of the subclavian vein of the patient P.
Next, as shown in FIG. 4B, the injection tube 101 is attached to the injection needle 102 of the introducer kit 100, and the injection needle 102 is punctured from the puncture position S behind the upper end of the sternum toward the subclavian vein.
When the piston of the syringe barrel 101 is pulled and venous blood is inhaled, the syringe needle 101 is removed while maintaining the position of the syringe needle 102, and the hub of the syringe needle 102 is immediately removed with a finger to prevent air intrusion and excessive bleeding. Cover.

Next, as shown in FIG. 4C, the guide wire 105 is inserted through the hub of the injection needle 102, and the guide wire 105 is guided into the blood vessel through the injection needle 102. When the guide wire 105 is advanced to the superior vena cava, the injection needle 102 is pulled out and removed.
Next, as shown in FIG. 4D, the introducer sheath 103 with the dilator 104 inserted is used as one unit, and a guide wire 105 is inserted therethrough. Then, the dilator 104 and the introducer sheath 103 are inserted into the puncture position S along the guide wire 105 and further advanced along the guide wire 105 into the subclavian vein and the superior vena cava. In this example, when the proximal end side opening 103a of the introducer sheath 103 reaches the right atrium, the insertion is stopped.
At this time, the proximal end sides of the dilator 104 and the introducer sheath 103 are extended from the puncture position S to the outside of the patient P by about 6 cm to 8 cm.

  Next, as shown in FIG. 4 (e), the introducer sheath 103 is left in the body, the dilator 104 and the guide wire 105 are removed, and in order to prevent air intrusion and excessive bleeding, the intro The proximal end side opening 103a of the deducer sheath 103 is covered.

Next, as shown in FIG. 5A, the electrode lead assembly 1 is inserted from the distal opening 6 b side of the protective sheath 6 into the proximal opening 103 a of the introducer sheath 103. At this time, the electrode lead assembly 1 is prepared in a state where the stylet 27 is inserted into the stylet insertion hole 4c in advance.
The inserted protective sheath 6 is advanced into the introducer sheath 103.
At this time, a sterilized lubricant may be lightly coated on the outer peripheral surface of the protective sheath 6 so that the protective sheath 6 can easily pass through the introducer sheath 103.

When the distal end portion of the protective sheath 6 comes out of the distal opening 103b in the right atrium, the insertion of the protective sheath 6 is stopped, and the lead portion 4 is pushed out while the positions of the introducer sheath 103 and the protective sheath 6 are fixed. Thereby, the electrode part 3 is pushed out from the front-end | tip opening 6b, is discharge | released outside the protective sheath 6, and the electrode part 3 enters into the heart. Therefore, the tip opening 6b is an opening that discharges the electrode portion 3 to the outside.
While confirming the position of the electrode part 3, the lead part 4 is pushed forward, and the electrode part 3 is placed at an installation position such as the tip of the right ventricle.

When the arrangement of the electrode part 3 is completed, as shown in FIG. 5B, the slitter 106 of the introducer kit 100 is attached to the lead part 4 extended outside the body. Then, taking care not to damage the lead portion 4 with the blade of the slitter 106, the protective sheath 6 and the introducer sheath 103 are torn along the axial direction, and these are pulled out of the patient's P body.
In this way, the protective sheath 6 and the introducer sheath 103 are removed from the electrode lead assembly 1 outside the blood vessel. Only the electrode lead 2 remains in the patient P's body.
Thus, the installation of the electrode lead 2 using the electrode lead assembly 1 is completed.

Thus, according to the electrode lead assembly 1, the electrode portion 3 and most of the lead portions 4 are covered with the protective sheath 6 in the assembled state. Is protected from abrasion during transportation.
Further, when the electrode lead assembly 1 is used, the electrode portion 3 and the lead portion 4 in the introducer sheath 103 are covered with the protective sheath 6 while being inserted into the introducer sheath 103 and proceeding through the introducer sheath 103. ing. For this reason, when the electrode part 3 and the lead part 4 pass through the hemostasis valve of the introducer sheath 103 or advance in the introducer sheath 103, the electrode part 3 and the lead part 4 become the inner wall of the hemostasis valve or the introducer sheath 103. There is no rubbing.
As a result, it is possible to prevent the surface of the electrode portion 3 and the lead portion 4 from being scratched by scratching when proceeding through the introducer sheath 103 bent in the body of the patient P. Further, when a coating for the purpose of anti-inflammation, anti-fibrosis, anti-thrombosis, immunosuppression or the like is applied to the surface of the electrode part 3 or the lead part 4, it is possible to prevent the coating from peeling off.

The electrode part 3 is pushed out from the protective sheath 6 in the vicinity of the installation position, and at this time, there is a possibility that abrasion occurs between the electrode part 3 and the inner wall part of the cylindrical part 6a. However, if the rubbing length for the electrode unit 3 is the length W ₁ of about, which is inserted into the body while the electrode unit 3 and the lead portion 4 is rubbed on the inner wall of the introducer sheath 103 as in the prior art Compared with, the scratch length is remarkably reduced.
Therefore, even if the electrode lead assembly 1 of this embodiment performs the installation operation using the introducer kit 100, the outer surface of the electrode lead 2 is not easily scratched.
For this reason, the micro flaw which generate | occur | produces on the outer surface of the electrode part 3 or the lead part 4 is reduced, and generation | occurrence | production of the fibrosis and thrombus which generate | occur | produces due to such a micro flaw can be reduced markedly. Moreover, since the peeling of the coating applied for the purpose of anti-inflammation, anti-fibrosis, anti-thrombosis, immunosuppression, etc. is reduced, the life of the electrode lead 2 can be improved.

[Modification]
An electrode lead assembly according to a modification of the first embodiment of the present invention will be described.
FIG. 6A is a schematic perspective partial cross-sectional view showing a configuration of an electrode lead assembly according to a modification of the first embodiment of the present invention. FIG. 6B is a partially enlarged view showing the shape of the electrode portion when unfolded.

  As shown in FIGS. 6 (a) and 6 (b), the electrode lead assembly 11 of the present modification is replaced with the electrode lead 2 and the protective sheath 6 of the electrode lead assembly 1 of the first embodiment, respectively. The electrode lead 12 and the protective sheath 6A (electrode part protecting member) are provided. Hereinafter, a description will be given centering on differences from the first embodiment.

The electrode lead 12 includes a patch electrode portion 13 (electrode portion) instead of the electrode portion 3 of the electrode lead 2 of the first embodiment.
The patch electrode unit 13 is installed so as to cover the biological tissue, and can apply electrical stimulation to the biological tissue or detect electrical excitation generated in the biological tissue in a state of being in close contact with the surface of the biological tissue. Is.
For this reason, as shown in FIG. 6 (b), the patch electrode portion 13 is formed of a film-like insulating base material 13b formed of a silicone material having elasticity, flexibility, insulation and biocompatibility. And an electrode 13a provided so that at least a part thereof is exposed on one surface of the insulating base 13b.

The electrode 13a is electrically connected to the lead wire 4a by extending the lead wire 4a in the lead portion 4 into the insulating base 13b.
In the present modification, the insulating base material 13 b is connected in a state of being eccentric to one side with respect to the central axis of the lead portion 4 at the tip portion of the lead portion 4.
The electrode 13a is formed in a film shape or a line shape that can be easily deformed with the deformation of the insulating base material 13b.
Therefore, the patch electrode 13, as shown in FIG. 6 (a), around the lead portion 4, wound spirally, the maximum outer diameter can be fold in D ₁ or less cylindrical. However, since the patch electrode portion 13 has elasticity, when the external force that maintains this folded state is released, the patch electrode portion 13 is developed by the elastic restoring force of the insulating base 13b as shown in FIG. Then, the shape before being folded is restored.
In this modification, the length along the axial direction of the lead portion 4 when the patch electrode 13 is collapsed is W _2.

The shape before the insulating base material 13b is folded is depicted in FIG. 6B as a circular shape along a plane as an example. However, the shape is not limited to this and depends on the living tissue at the installation position. Thus, an appropriate shape can be adopted. For example, it can be formed into an appropriate shape such as an elliptical shape, a rectangular shape, or a polygonal shape. Moreover, not only the shape along a plane but the shape along appropriate curved surfaces, such as cylindrical surface shape, may be sufficient.
In addition, the shape of the electrode 13a is illustrated as a disk-shaped monopolar type as an example in FIG. 6B, but is not limited thereto, and may be a linear pattern made of straight lines, curves, or the like. Further, the linear pattern may be arranged in a lattice shape, a net shape, a concentric circle shape, or the like.
The electrode 13a is not limited to the monopolar type, and may be a bipolar type. Three or more electrodes 13a may be provided in the insulating base material 13b.

The protective sheath 6A is located radially inward from the distal end opening 6b at a distance W ₃ (W ₃ ≧ W ₂ ) on the inner peripheral surface of the cylindrical portion 6a of the protective sheath 6 of the first embodiment. A protruding stopper 6e is added.
The shape of the stopper 6e, in the cylindrical portion 6a, and regulate the axial position of the state of the patch electrode portion 13 is folded, the patch electrode portions 13 of the cylindrical portion 6a of the front end portion of the length W ₂ There is no particular limitation as long as it is a protrusion that stops within the range. In this modification, as one example, it is projected so as to form an annular when viewed from the inner peripheral surface of the cylindrical portion 6a from the axial direction, at the center thereof, an inner diameter larger than the outer diameter d ₀ of the lead portion 4 A shape in which a through hole smaller than the maximum outer diameter of the patch electrode portion 13 in a folded state is formed is employed.

The electrode lead assembly 11 of this modification can be assembled in the same manner as the electrode lead assembly 1 of the first embodiment.
However, when the connector part 5 is connected to the end part of the lead part 4 and the patch electrode part 13 is accommodated in the protective sheath 6, it can be inserted into the tip opening 6b by winding and folding the patch electrode part 13 A cylindrical shape is used, and this cylindrical state is held by an assembler's hand or an appropriate holding jig. Then, while holding the patch electrode portion 13 in a folded state, the lead portion 4 is pulled to the proximal end side, and the patch electrode portion 13 is inserted into the cylindrical portion 6a.
Since the patch electrode portion 13 inserted into the cylindrical portion 6a and released from holding on the outside is to be expanded by the elastic restoring force, the diameter thereof is expanded within the range of the inner diameter of the cylindrical portion 6a, and the elastic restoring force is determined. To press the inner wall. However, the pressing force in this state is so large that the relative movement in the axial direction between the patch electrode portion 13 and the tubular portion 6a is not hindered when the electrode lead 12 is pushed out by the stylet 27. Set it.
For this reason, in the electrode lead 12, as in the first embodiment, the proximal end side of the lead portion 4 is slidably locked along the longitudinal direction of the lead portion 4 by the hemostasis valve 6c. The outer peripheral portion of the folded patch electrode portion 13 is slidably locked along the longitudinal direction of the lead portion 4 (the axial direction of the tubular portion 6a) by the inner wall of the shape portion 6a.

In this modification, since the stopper 6e is provided, the patch electrode part 13 cannot move to the base end side rather than the stopper 6e. Therefore, it is possible to assemble the patch electrode portion 13 in a state where the patch electrode portion 13 is reliably disposed in the space between the tip opening 6b and the stopper 6e.
Moreover, it does not push too much into the base end side. For this reason, when the patch electrode part 13 is extruded, the distance which scrapes with the cylindrical part 6a can be reduced.

The electrode lead assembly 11 assembled in this way can be installed in the body of the patient P in the same manner as the electrode lead assembly 1 of the first embodiment using the introducer kit 100.
However, in this modification, when the patch electrode part 13 pushed out from the cylindrical part 6a moves to the outside of the cylindrical part 6a, an elastic restoring force acts to try to expand in the living body.
For this reason, the patch electrode portion 13 needs to be pushed out in a place where it can move to the installation position even after deployment, or if it cannot be easily moved after deployment, it needs to be pushed out in the vicinity of the installation position.

Moreover, in this modification, by pushing out the patch electrode part 13 in a place where it cannot be expanded to the shape before being folded, it is possible to fix the position of the pushed patch electrode part 13 in the living body using its elastic restoring force. It becomes.
For example, in order to install the patch electrode unit 13 along the inner wall of a blood vessel such as the superior vena cava, the development length of the patch electrode unit 13 is set to be larger than ½ of the peripheral length of the inner wall of the blood vessel to be installed. Then, the patch electrode unit 13 is pushed out into the blood vessel at the installation position. Thereby, the patch electrode part 13 will expand | deploy in the C shape curved rather than the state before folding in the blood vessel, and will be in the state which presses the inner wall of the blood vessel with an elastic restoring force. For this reason, the patch electrode part 13 is installed in close contact with the inner wall of the blood vessel in the vicinity of the pushed-out position.

[Second Embodiment]
An electrode lead assembly according to a second embodiment of the present invention will be described.
FIG. 7A is a schematic perspective partial cross-sectional view showing a configuration of an electrode lead assembly according to the second embodiment of the present invention. FIG. 7B is a perspective partial cross-sectional view of the electrode portion protection member of the electrode lead assembly according to the second embodiment of the present invention. FIG. 8A is a schematic front view showing an example of an introducer kit for introducing the electrode lead assembly according to the second embodiment of the present invention into a living body. FIG. 8B is a perspective partial sectional view showing a detailed configuration of a portion C in FIG.

As shown in FIGS. 7A and 7B, the electrode lead assembly 21 of the present embodiment is replaced with a protective cap 26 (electrode) instead of the protective sheath 6 of the electrode lead assembly 1 of the first embodiment. Part protection member).
In this embodiment, when the electrode lead assembly 21 is inserted into the living body, the introducer kit 110 shown in FIG. 8A is used in place of the introducer kit 100 of the first embodiment.
In the electrode lead assembly 21 according to the present embodiment, the electrode part 3 in which the fibrosis or thrombus is likely to occur in the electrode lead 2 is more complicated in shape than the lead part 4 and is always in direct contact with a living body. In particular, by reducing minute scratches generated in the electrode part 3, fibrosis and thrombus generation can be efficiently reduced.
Hereinafter, a description will be given centering on differences from the first embodiment.

The protective cap 26 is a member that protects the outer peripheral portion of the electrode portion 3 so that the surface of the electrode portion 3 does not rub against the introducer kit 110 when the electrode lead 2 is inserted through the introducer kit 110.
The protective cap 26 includes a cylindrical portion 26 </ b> A (outer shape restricting portion) provided in a cylindrical shape that accommodates the electrode portion 3.
One end of the cylindrical portion 26A is opened as the distal end opening 26b of the inner diameter _{D 4} (opening). The other end portion of the cylindrical portion 26A is provided with a locking portion 26B that slidably locks the cylindrical portion 26A along the longitudinal direction (axial direction) of the lead portion 4 of the electrode lead 2.

The cross-sectional shape of the cylindrical portion 26A is an annular shape composed of concentric circles having an inner diameter of D ₄ and an outer diameter of D ₅ . The inner diameter D ₄ is set to be larger than the outer diameter d ₁ of the electrode part 3 in order to accommodate the electrode part 3.
Outer diameter D ₅ is set below the internal diameter D ₀ of the introducer sheath 103A which will be described later, there is a insertable size hemostasis valve provided on the proximal side opening 103a.
Further, the length of the cylindrical portion 26 </ b> A is set to a length W ₄ slightly longer than the length W ₁ of the electrode portion 3.

The locking portion 26B is in the center of the cylinder block having the same outer diameter as the cylindrical portion 26A, greater than the diameter d _0, in which the insertion hole 26a is provided having an inner diameter smaller than the diameter d _1. For this reason, the insertion hole 26a is a hole through which the lead portion 4 can be inserted and the electrode portion 3 cannot pass through. The insertion hole 26 a has a smooth surface so that the lead portion 4 is not damaged even when sliding with the lead portion 4.
An O-ring 26d that is slidably adhered to the outer peripheral portion of the lead portion 4 in the axial direction is installed at an intermediate portion of the insertion hole 26a.
The length of the locking portion 26B in the axial direction is sufficient as long as at least the O-ring 26d can be provided, and is shorter than the length of the cylindrical portion 26A.
By such a locking portion 26B, a stopper portion 26c is formed on the other end side of the cylindrical portion 26A so as to protrude inward from the inner diameter of the cylindrical portion 26A.

Since the locking portion 26B has the insertion hole 26a and the O-ring 26d, the locking portion that locks the electrode lead 2 slidably along the longitudinal direction (axial direction) of the lead portion 4 in the protective cap 26. Is configured.
Further, the cylindrical portion 26A constitutes an outer shape restricting portion provided in a shape projecting radially outward from the outer shape of the electrode portion 3 on the outer peripheral side of the locking portion 26B.
The material of the protective cap 26 can be the same material as that of the protective sheath 6 of the first embodiment.

Next, the structure of the introducer kit 110 used for inserting the electrode lead assembly 21 into the living body will be described.
The introducer kit 110 includes an introducer sheath 103A in place of the introducer sheath 103 of the introducer kit 100 of the first embodiment.
As shown in FIG. 8B, the introducer sheath 103A includes a distal end side opening 103b having a diameter smaller than that of the proximal end side opening 103a, instead of the proximal end side opening 103a of the introducer sheath 103. In the present embodiment, the distal end side opening 103b is an annular shape having an inner diameter D ₃ (d ₁ <D ₃ <D ₅ ) protruding radially inward at the position of the proximal end opening 103a of the introducer sheath 103. A stopper 103d is provided, and an opening formed by the inner periphery is a tip side opening 103b.

The electrode lead assembly 21 of this embodiment can be assembled in the same manner as the electrode lead assembly 1 of the first embodiment.
In this assembled state, the outer peripheral part of the electrode part 3 is assembled in a positional relationship covered from the side by the cylindrical part 26A.

  The electrode lead assembly 21 of the present embodiment can be installed in the body of the patient P using the introducer kit 110 in substantially the same manner as the electrode lead assembly 1 of the first embodiment. Hereinafter, a description will be given centering on differences from the first embodiment.

Until the introducer sheath 103A is inserted into the blood vessel of the patient P using the syringe barrel 101, the injection needle 102, the guide wire 105, and the dilator 104, the introducer sheath 103 of the first embodiment is introduced. Except for the replacement with the sheath 103A, it is exactly the same.
However, in the present embodiment, when the protective cap 26 is inserted into the introducer sheath 103A, only the lead portion 4 having a smaller diameter than the protective cap 26 passes through the hemostasis valve of the proximal end side opening 103a. Therefore, the sliding resistance with the hemostasis valve is reduced compared to the first embodiment.

After removing the dilator 104 and the guide wire 105, the electrode lead assembly 21 is moved from the distal end opening 26b side of the protective cap 26 to the proximal end side opening 103a of the introducer sheath 103A as shown in FIG. Insert and advance protective cap 26 into introducer sheath 103A. At this time, the stylet 27 is inserted into the stylet insertion hole 4c of the electrode lead assembly 21 in advance.
Since the protective cap 26 of the electrode lead assembly 21 is locked to the lead portion 4 by an O-ring 26d and there is a gap with the introducer sheath 103A, when the stylet 27 is pushed in, together with the electrode portion 3 The protective cap 26 locked to the lead portion 4 also advances into the introducer sheath 103A. For this reason, the outer peripheral part of the electrode part 3 is protected by the cylindrical part 26A, and the electrode part 3 and the inner wall of the introducer sheath 103A do not contact.
Further, similarly to the protective sheath 6 of the first embodiment, the outer periphery of the protective cap 26 may be lightly coated with a sterilized lubricant.

Further, when the protective cap 26 is pushed in, the front end portion of the protective cap 26 abuts against the stopper 103d. Thereafter, the surgeon holds the introducer sheath 103A so as not to move, and further pushes the stylet 27. When a force greater than the static frictional force between the O-ring 26d and the lead part 4 is applied by the stylet 27, the lead part 4 starts to slide with respect to the O-ring 26d, and the electrode part 3 and the tip opening 26b of the protective cap 26 and the intro It is discharged to the outside of the protective cap 26 through the distal end side opening 103b of the deducer sheath 103A. Thereby, the electrode part 3 is pushed out into the blood vessel of the patient P, and the electrode part 3 enters into the heart.
Further, while confirming the position of the electrode part 3, the lead part 4 is pushed forward, and the electrode part 3 is disposed at an installation position such as the tip of the right ventricle.

When the placement of the electrode unit 3 is completed, the introducer sheath 103A is torn along the axial direction using the slitter 106 of the introducer kit 100 and is pulled out of the patient P, as in the first embodiment. To go. However, in this embodiment, until the protective cap 26 appears, only the introducer sheath 103A needs to be torn, which is a simple operation compared to the first embodiment.
Since the protective cap 26 is locked to the stopper 103d while the introducer sheath 103A is pulled out, the protective cap 26 is pulled out of the body together with the introducer sheath 103A.
When the protective cap 26 appears at the operator's hand, the protective cap 26 is also torn off by the slitter 106 and removed.
In this way, the protective cap 26 is removed from the electrode lead assembly 21, and the introducer sheath 103A is also removed outside the blood vessel. Only the electrode lead 2 remains in the patient P's body.
Thus, the installation of the electrode lead 2 using the electrode lead assembly 21 is completed.

Thus, according to the electrode lead assembly 21, in the assembled state, the electrode part 3 is covered by the protective cap 26, and the electrode part 3 is protected from abrasion during transportation.
Further, when the electrode lead assembly 21 is used, the electrode portion 3 in the introducer sheath 103 A is covered with the protective cap 26 while being inserted into the introducer sheath 103A and proceeding through the introducer sheath 103A. For this reason, when the electrode portion 3 passes through the hemostasis valve of the introducer sheath 103A or advances through the introducer sheath 103A, the electrode portion 3 does not rub against the hemostasis valve or the inner wall of the introducer sheath 103A.
For this reason, it is possible to prevent the surface of the electrode portion 3 from being scratched by rubbing when proceeding through the introducer sheath 103 bent in the body of the patient P. Moreover, when the coating for the purpose of anti-inflammatory, anti-fibrosis, anti-thrombosis, immunosuppression, etc. is given to the surface of the electrode part 3, it can prevent that a coating peels.

The electrode portion 3 is pushed out from the protective cap 26 in the vicinity of the installation position, and at this time, scratching occurs between the electrode portion 3 and the inner wall portion of the cylindrical portion 26A, but the scratch length is the same as in the first embodiment. as with forms, since the length W ₁ of about electrode portions 3, abrasion length in the same manner it is greatly reduced.
Therefore, in the electrode lead assembly 21 of the present embodiment, the outer surface of the electrode portion 3 is smaller than when the electrode lead 2 is directly passed through the introducer sheath 103A even when the installation work using the introducer kit 110 is performed. It is much harder to be abraded.
Therefore, the micro flaw which generate | occur | produces on the outer surface of the electrode part 3 is reduced, and generation | occurrence | production of the fibrosis and thrombus which generate | occur | produces due to such a micro flaw can be reduced markedly. Moreover, since the peeling of the coating applied for the purpose of anti-inflammation, anti-fibrosis, anti-thrombosis, immunosuppression, etc. is reduced, the life of the electrode lead 2 can be improved.

  Further, since the protective cap 26 is a member that covers the outer peripheral side of the electrode portion 3 from the side, the protective cap 26 can be manufactured with a dimension corresponding to the shape of the electrode portion 3 and does not depend on the length of the lead portion 4. For this reason, the number of types of shapes can be reduced, and cost reduction can be achieved.

[Third Embodiment]
An electrode lead assembly according to a third embodiment of the present invention will be described.
FIG. 9A is a schematic perspective partial cross-sectional view showing the configuration of the electrode lead assembly according to the third embodiment of the present invention. FIG. 9B is a perspective partial cross-sectional view of the electrode portion protection member of the electrode lead assembly according to the second embodiment of the present invention. FIG. 10: is typical sectional drawing explaining the effect | action of the electrode part protection member in the 3rd Embodiment of this invention.

As shown in FIGS. 9A and 9B, the electrode lead assembly 31 of the present embodiment is replaced with a protective ring 36 (electrode) instead of the protective cap 26 of the electrode lead assembly 21 of the second embodiment. Part protection member).
Hereinafter, a description will be given focusing on differences from the second embodiment.

When the electrode lead 2 is inserted through the introducer kit 110, the protective ring 36 regulates the insertion position of the electrode unit 3 so that the surface of the electrode unit 3 does not rub against the introducer kit 110. It is the member which protects the part.
The protective ring 36 is a member obtained by deleting the cylindrical portion 26A of the protective cap 26 of the second embodiment and changing the outer dimension of the locking portion 26B.
That is, as shown in FIG. 9B, the protective ring 36 has an insertion hole 26a formed at the center of a cylindrical block having a cylindrical outer peripheral surface 36a having an outer diameter D ₆ and a length W ₅ . It is a member. An O-ring 26d is provided at the intermediate portion of the insertion hole 26a as in the second embodiment.
The protection ring 36 is assembled in a state of being locked to the lead portion 4 by the insertion hole 26a and the O-ring 26d at a position adjacent to the proximal end side of the electrode portion 3.

The outer diameter D ₆ and the length W ₅ of the outer peripheral surface 36 a are such that the outer diameter D ₆ satisfies the condition of at least d ₁ <D ₆ ≦ D ₀ and is inserted into the protector ring 36 when inserted into the introducer sheath 103. The dimensions are set such that the electrode portions 3 arranged adjacent to each other do not come into contact with the protective ring 36.
That is, as shown in FIG. 10, when the protective ring 36 is most inclined with respect to the central axis of the introducer sheath 103A within the gap between the inner wall of the introducer sheath 103A and the outer diameter of the electrode portion 3 However, the dimension may be such that it does not contact the inner wall of the introducer sheath 103A. For simplicity, FIG. 10 shows an example in which the introducer sheath 103A is not bent. However, since the introducer sheath 103A is curved in the blood vessel, it is actually designed with a margin in consideration of this curved portion. To do.
Specifically, first, the length W ₅ of the protective ring 36, introducer sheath 103A is set to a width that can be passed along the curved be maximally bent in the vessel. Next, an allowable inclination amount of the protective ring 36 is obtained in consideration of a margin due to bending. The inclination of the protective ring 36 in the introducer sheath 103A when the length W ₅ calculates the outer diameter D ₆ such that less than the allowable amount of tilt.

The insertion hole 26a and the O-ring 26d of the protection ring 36 constitute an engaging portion that is slidably engaged with the electrode lead 2 along the longitudinal direction (axial direction) of the lead portion 4.
Further, the outer peripheral surface 36a of the protective ring 36 constitutes an outer shape restricting portion provided in a shape projecting radially outward from the outer shape of the electrode portion 3 on the outer peripheral side of the locking portion 26B.

  The electrode lead assembly 31 of this embodiment can be assembled in the same manner as the electrode lead assembly 21 of the second embodiment.

  The electrode lead assembly 31 of this embodiment can be installed in the body of the patient P in substantially the same manner as the electrode lead assembly 21 of the second embodiment using the introducer kit 110. Hereinafter, a description will be given focusing on differences from the second embodiment.

In the present embodiment, until the electrode lead assembly 31 is pushed into the introducer sheath 103A, the electrode portion 3 rubs against the hemostasis valve when passing through the hemostasis valve at the proximal end opening 103a, except for the above. This is the same as in the second embodiment.
In the present embodiment, when the electrode unit 3 is pushed into the introducer sheath 103 </ b> A disposed in the blood vessel of the patient P, the protective ring 36 does not cover the outer periphery of the electrode unit 3. However, by setting the protective ring 36 as described above, there is a gap between the electrode portion 3 and the inner wall of the introducer sheath 103A, no matter how it moves in the introducer sheath 103A. Can keep. For this reason, rubbing between the electrode portion 3 and the introducer sheath 103A does not occur.
When the electrode portion 3 and the protective ring 36 reach the distal end portion of the introducer sheath 103A, the electrode portion 3 is pushed forward in a state of being locked to the central portion of the protective ring 36, so that it contacts the inner wall of the introducer sheath 103A. Without doing so, the electrode portion 3 passes through the distal end side opening 103b and enters the blood vessel. Thereafter, the protection ring 36 is locked to the stopper 103d, and the movement of the protection ring 36 is stopped.

Further, when the stylet 27 is pushed in and a force greater than the static frictional force between the O-ring 26d and the lead part 4 is applied through the stylet 27, the lead part 4 starts to slide against the O-ring 26d, and the electrode part 3 further moves. Then, it moves in the blood vessel of the patient P. As a result, the electrode portion 3 exits from the distal end opening 6b and enters the heart.
Further, while confirming the position of the electrode part 3, the lead part 4 is pushed forward, and the electrode part 3 is disposed at an installation position such as the tip of the right ventricle.

When the placement of the electrode unit 3 is completed, the introducer sheath 103A is removed in the same manner as in the second embodiment. Further, when the protective ring 36 appears at the operator's hand, the protective ring 36 is also cut and removed by the slitter 106.
In this manner, the protective ring 36 is removed from the electrode lead assembly 31 and the introducer sheath 103A is also removed from the blood vessel, so that only the electrode lead 2 remains in the body of the patient P.
Thus, the installation of the electrode lead 2 using the electrode lead assembly 31 is completed.

As described above, in the assembled state, the electrode lead assembly 31 is only rubbed against the hemostasis valve when passing through the introducer sheath 103A even if the electrode portion 3 is not covered. In this example, the electrode portion 3 can be disposed in the blood vessel without rubbing the inner wall of 103A.
For this reason, compared to the second embodiment, there is a possibility that the electrode part 3 may be scratched in that it is scratched by the hemostasis valve, but the tip side opening 103b passes through without being scratched reliably. In this respect, the occurrence of scratches can be suppressed more than in the second embodiment.
For this reason, when advancing through the introducer sheath 103 disposed in the body of the patient P, it is possible to more reliably prevent the surface of the electrode unit 3 from being scratched by scratching. Moreover, when the coating for the purpose of anti-inflammatory, anti-fibrosis, anti-thrombosis, immunosuppression, etc. is given to the surface of the electrode part 3, it can prevent that a coating peels.
As described above, the electrode lead assembly 31 according to the present embodiment has an outer portion of the electrode portion 3 that is more than the case where the electrode lead 2 is directly passed through the introducer sheath 103A even when the introducer kit 110 is used. The surface is much less likely to be scratched.
Therefore, the micro flaw which generate | occur | produces on the outer surface of the electrode part 3 is reduced, and generation | occurrence | production of the fibrosis and thrombus which generate | occur | produces due to such a micro flaw can be reduced markedly. Moreover, since the peeling of the coating applied for the purpose of anti-inflammation, anti-fibrosis, anti-thrombosis, immunosuppression, etc. is reduced, the life of the electrode lead 2 can be improved.

In the description of the first embodiment, its modification, and the second embodiment, the protective sheaths 6, 16, and 26 are provided so that the abrasion of the electrode portion 3 or the patch electrode portion 13 can be reliably reduced. The case where the tip portion of the electrode portion 3 or the patch electrode portion 13 is not exposed is described as being covered with the tip portion. However, even if a part of the electrode part 3 or the patch electrode part 13 is exposed from the protective sheath 6, 16, 26, the exposure amount is small, and the electrode part 3 or the patch electrode part exposed inside the introducer sheath 103, 103A. If 13 does not rub against the inner walls of the introducer sheaths 103 and 103A, it may be left exposed.
That is, the outer shape restricting portion may be provided in a cylindrical shape that covers at least a part of the electrode portion from the outer peripheral side.

Further, in the description of the operation of the second embodiment, it has been described that when the electrode portion 3 is pushed out from the protective cap 26, rubbing occurs between the cylindrical portion 26A and the electrode portion 3, but this is an example. In the second embodiment, rubbing does not always occur.
For example, the outer diameter d ₁ of the electrode unit 3, if somewhat smaller than the inner diameter D ₄ of the cylindrical portion 26A, the center portion of the electrode unit 3 when extruding by inserting the stylet 27 the cylindrical portion 26A Therefore, it is possible to prevent the electrode portion 3 and the cylindrical portion 26A from rubbing at all.

In the above description, the protective sheaths 6 and 6A, the protective cap 26, and the protective ring 36 are described as examples in the case of a closed shape in the circumferential direction such as a tubular shape or an annular shape. As long as the electrode part 3 can be protected from scratching when moving in the deducer sheaths 103 and 103A, it does not have to be closed in the circumferential direction. For example, slits may be provided in advance in the respective axial directions, and the openings may be provided in a shape having a C-shaped cross section.
In this case, when the protective sheaths 6 and 6A, the protective cap 26, and the protective ring 36 are assembled to the electrode lead 2, the C-shaped opening can be opened and assembled from the side of the electrode lead 2; In addition, it is possible to further reduce abrasion during assembly with the lead portion 4.
Further, when removing the protective sheath 6, 6 </ b> A, the protective cap 26, and the protective ring 36, it can be easily removed without being cut by the slitter 106.

In the description of the modification of the first embodiment, the patch electrode unit 13 is described as an example in which the patch electrode unit 13 is wound in a roll shape and is folded. However, such a folding method is an example. For example, it may be folded, stretched and folded, compressed and folded, or folded in a twisted state.
Moreover, although the patch electrode part 13 was demonstrated as what is expand | deployed by the elasticity of the insulating base material 13b, for example, a super elastic alloy wire etc. is incorporated in the inside of the insulating base material 13b, and is expand | deployed by this elastic restoring force. You may do it.
Moreover, the electrode part folded so that it may expand | deploy outside when it discharge | releases from opening is not limited to the patch electrode part which touches a biological body planarly. For example, it may be an electrode portion having a wire frame structure that restores the developed shape.

  In the description of the second and third embodiments, an example in which one O-ring 26d is provided in the insertion hole 26a has been described. However, two O-rings 26d are spaced from each other in the insertion hole 26a. May be installed. In this case, the lead portion 4 to be locked can be more easily aligned with the central axis of the protective cap 26 and the protective ring 36, so that the electrode portion 3 is held along the central axis of the protective cap 26 and the protective ring 36. Easy to do. For this reason, it becomes easy to make the clearance gap between the electrode part 3 and the inner wall of 26 A of cylindrical parts, or introducer sheath 103A.

Moreover, in said 2nd, 3rd embodiment, it demonstrated by the example in the case of inserting using not the introducer kit 100 but the introducer kit 110. FIG. In this case, since the introducer kit 110 has the stopper 103d, the discharge of the electrode portion 3 from the protective cap 26 and the protective ring 36 and the recovery of the protective cap 26 and the protective ring 36 are facilitated.
However, if the positions of the protective cap 26 and the protective ring 36 can be fixed when the electrode portion 3 is pushed out, and the protective cap 26 and the protective ring 36 can be recovered outside the blood vessel, the introducer kit 100 without the stopper 103d. May be used. For example, if the protective cap 26 and the protective ring 36 are provided with a wire extending to the base end side, the positions of the protective cap 26 and the protective ring 36 are fixed when the electrode unit 3 is pushed out by pulling the wire. Then, after the end of the extrusion, it can be pulled back to the base end side and recovered.

  In addition, all the components described in the above embodiments and modifications can be implemented by appropriately combining, deleting, or replacing them within the scope of the technical idea of the present invention.

1, 11, 21, 31 Electrode lead assembly 2, 12 Electrode lead 3 Electrode part 3c Tind 4 Lead part 4a, 4b Conductor 5 Connector part 6, 6A Protective sheath (electrode part protective member)
6a Tubular part (outer shape restricting part)
6b, 26b Tip opening (opening)
6c hemostatic valve (locking part)
6e Stopper 13 Patch electrode part (electrode part)
26 Protection cap (electrode part protection member)
26A Tubular part (outer shape restricting part)
26B Locking part 26a Insertion hole 26a
26c Stopper part 26d O-ring 36 Protection ring (electrode part protection member)
36a Outer peripheral surface (outer shape restricting part)
100, 110 Introducer kit 103, 103A Introducer sheath P Patient

Claims (4)

A wire-like lead portion in which a conductive wire is insulated, an electrode portion electrically connected to the lead wire at one end side of the lead portion, and a connector portion electrically connected to the lead wire at the other end side of the lead portion An electrode lead having
The electrode lead is provided with a locking portion that is slidably locked along the longitudinal direction of the lead portion, and a shape that protrudes radially outward from the outer shape of the electrode portion on the outer peripheral side of the locking portion. An electrode part protection member having an outer shape regulating part,
An electrode lead assembly comprising: The outer shape restricting part is
2. The electrode lead assembly according to claim 1, wherein the electrode lead assembly has an opening that discharges the electrode part to the outside, and is provided in a cylindrical shape that covers at least a part of the electrode part from the outer peripheral side. The outer shape restricting part is
The electrode lead assembly according to claim 2, wherein the electrode lead assembly is provided in a cylindrical shape covering the entire electrode portion from the outer peripheral side. The electrode part is
When released from the opening, it is folded to expand outside,
The outer shape restricting part is
The electrode lead assembly according to claim 2, wherein the electrode lead assembly is provided in a cylindrical shape covering at least a part of the electrode portion in a folded state from the outer peripheral side.

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