JPH10216243A - Electrode attaching/detaching device for in-organism implantation device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To drastically simplify an operation for mechanically fixing electrode reeds, to keep high reliability after fixing and also to positively prevent the damage of the electrode reeds by a misoperation at the time of operating. SOLUTION: This electrode attaching/detaching device for in--organism implantation device is provided with a connector part 11 which inserts/ejects the plural electrode reeds 2 connected to the in-living body planting device 10 so as to be freely attachable/detachable with an insertion hole 11a and also which executes holding in a liquid-tight state, a pressurizing member 6 which is provided so as to be freely rotatable aroung a shaft in parallel with the longitudinal direction of the electrode reeds 2 and which is moved to a first state with separation from the outer peripheral surfaces of the electrode reeds 2 and to the second state with pressurization and a holding member 5 which holds the pressurizing member 6 in one of the first and the second states.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an electrode attaching / detaching device for an implantable device in a living body, and more particularly to a device configured to perform electrical measurement or to stimulate a predetermined site by being implanted in a living body. The present invention relates to a device for removably fixing an electrode of an in-vivo implant device suitably used for an implantable treatment device such as a cardiac pacemaker or a defibrillator.

[0002]

2. Description of the Related Art A cardiac pacemaker and a defibrillator, which are implantable devices in a living body, have a main body in which an electronic circuit and a battery power supply are built in, and a main body for applying an electric stimulus and acquiring a sensing signal. And an electrode lead detachably provided to the main body to electrically connect to an appropriate part in the heart.

In general, according to such an implantable device in the living body, the electrode lead is first placed or fixed at a predetermined site in the heart, and then the electrode lead is inserted into the connector portion of the device body from the tip. Thus, it is mechanically fixed so as to establish electrical continuity to ensure a sealed state from body fluids.

Referring to the drawings, a description will be given of a conventional electrode attaching / detaching device for a connector portion on the main body side. FIG. 7 shows an electrode lead after being fixed in a connector housing 111 which is a connector portion provided on the main body 10. FIG. 2 is a cutaway view of a main part, which is a cutaway view of a cutting surface 102 along a longitudinal direction thereof.
FIG. 8 is a sectional view taken along the line AA of FIG.

[0007] First, in FIG. 7, a connector housing 111 having a shape as shown in the figure is provided in a part of the main body 10, and an electrode lead 102 provided with a ring-shaped body fluid seal 103 inside the connector housing 111. Are inserted as shown in the figure, and the two electrical connection terminal portions 151 formed on the electrode lead 102 are fixed.

[0007] To this end, referring to FIG. 7 and FIG. 8, each electric connection terminal 151 is arranged so as to pass through the through hole 105 a of the block 105 formed of a conductor. The electrical connection terminal section 151 is stopped by tightening the set screw 106 by rotating a set screw 106 screwed in a through screw hole 105b formed continuously in a direction orthogonal to the through hole 105a by a screwdriver or the like. Screw 106 and through hole 10 of block 105
5a, and then the sealing member 1
07 is used for sealing.

In order to remove each electrode lead 102 for exchanging the main unit 10, for example, the sealing member 1 is used.
After removing 07, loosen the set screw 106,
The connector is pulled out from the connector housing 111.

In this manner, the electrode lead 102
For electrical connection to the main body 10 and mechanical fixing can be simultaneously performed by rotating the set screw 106.

[0009]

However, according to the above-mentioned conventional system, the following problems have been pointed out.

That is, according to a general cardiac pacemaker using the electrode lead 102 fixed as described above, two blocks 105 are used for each electrode lead, and the electrode lead is used at two positions. The electrical contacts must be individually fixed. As a result, the set screw 1
Turning the 06 with a tool is at least 2 per lead
Since the fixing operation has to be performed a number of times, the fixing operation is very complicated, but one of them may be forgotten to be tightened.

Since the set screw 106 is not provided with a positive rotation restricting means, the set screw 106 and the electrode lead electrical contact portion 151 may be damaged due to excessive tightening.

If the set screw 106 is excessively loosened when removing the electrode lead 102, the block 1
05 may fall off.

Since the electrical connection and the mechanical fixing mechanism are configured in the same way, conduction failure occurs when body fluid enters the screw portion 105b of the block 105. From this,
It is necessary to separately provide a dedicated sealing member 107 shown in the figure.

At least four problems have been pointed out.

Therefore, the present invention has been made in view of the above-mentioned problems, and a plurality of electrode leads which are detachably connected to a connector portion of a living body implanting device are provided.
By fixing the electrode lead immovably at a position closer to the insertion port side of the connector part than the sealing mechanism for body fluid provided as standard on the electrode lead, An object of the present invention is to provide an electrode attaching / detaching device of an in-vivo implanting device, which can greatly simplify an attaching / detaching operation.

More specifically, a mechanism composed of a pressing member, a holding member, and a block member, which are interlocked with each other, is disconnected from a mechanism for electrical connection and mechanical fixing, and a unit provided as a standard on an electrode lead. By arranging it at a position closer to the electrode lead insertion opening of the connector part than the installation position of the seal, it is possible to mechanically securely fix a plurality of electrode leads in one operation, and to prevent the holding member from coming off, It is intended to provide a mechanism for preventing overtightening.

[0017]

Means for Solving the Problems The above-mentioned problems are solved,
In order to achieve the object, according to the electrode attaching / detaching device of the in-vivo implanting device of the present invention, a connector for holding a plurality of electrode leads detachably connected to the in-vivo implanting device in a liquid-tight state. A pusher provided rotatably about an axis parallel to the longitudinal direction of the electrode lead, and moved between a first state for pressing the outer peripheral surface of the electrode lead and a second state separated from the outer peripheral surface. It is characterized by comprising a member and a holding member for holding the pressing member in one of the first state and the second state.

Also, preferably, there is provided an electrode attaching / detaching device for a living body implanting device, wherein the connector portion holds a plurality of electrode leads detachably connected to the living body implanting device in a liquid-tight state; A pressing member rotatably provided around an axis parallel to the longitudinal direction of the lead and moved between a first state for pressing the outer peripheral surface of the electrode lead and a second state separated from the outer peripheral surface; A holding member for holding the pressing member in one of the first state and the second state, and a through-hole portion through which the pressing member, the holding member, and the electrode lead are inserted. And a block member inserted and fixed through an opening formed in the connector portion.

[0019]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments according to the present invention will be described below in detail with reference to the accompanying drawings. FIG. 1 is an external perspective view of the connector portion 11 of the in-vivo implant device 1 as viewed obliquely from above, and FIG. 2 is an external perspective view of the connector portion 11 as viewed obliquely from above after fixing the electrode leads. In both figures, the mounting state of the electrode lead fixing mechanism 20 is shown.

First, in FIG. 1, an electrode lead fixing mechanism 20 is provided with an arrow D2 shown in the figure against an opening 11b on a side surface of a connector portion 11 provided on the body 10 of, for example, a cardiac pacemaker device which is the living body implanting device 1. It is separately configured so that it can be inserted in any direction.

On the other hand, two electrode lead insertion holes 11a, which are formed obliquely as shown in the figure, are formed in the left side portion of the connector portion 11, and the electrode leads 2 are inserted in the direction of arrow D1 in the figure. Each of the electrode leads 2 is configured to be inserted and electrically connected to a body fluid provided as a standard on the electrode lead 2 by a member (not shown) on the distal end side of the seal portion 3. That is, the electrode lead fixing mechanism 20 is provided for mechanically fixing the electrode lead 2 at a position closer to the insertion hole 11a side of the connector portion 11 so that the electrode lead 2 does not move.

The fixing mechanism 20 includes a block member 4, a plate member 6 as a pressing member, and a screw member 5 as a holding member.
And three components.

The block member 4 forming the outer shape of the fixing mechanism 20 includes a side opening 11b formed in the connector portion 11.
The block member 4 is integrally formed with a projection 48 corresponding to the side opening 11c of the connector 11 shown in FIG. 2 on a one-to-one basis. The plurality of through holes 41 and 43 provided in the block member 4 and the connector
The side electrode lead insertion holes 11a are coaxial with each other. In this way, the fixing mechanism 20 can be easily arranged in the connector section 11 so that the assembling work is facilitated. Further, when the block member 4, the plate member 6, and the screw body 5 are manufactured using a mold, an under part is not formed, so that an inexpensive mold can be used.

FIG. 3 is a three-dimensional exploded view of the fixing mechanism 20 as viewed obliquely from below. In the drawing, the block member 4
Are formed with through-holes 42 and 44 coaxial with the through-holes 41 and 43 described above. The block member 4 is provided with an opening 49 for rotatably mounting the plate member 6, and the plate member 6 provided with hinges 62 and 63 to be fitted in U-shaped linear grooves 45 and 46 at the bottom. It is configured to set in the direction of arrow D3 in the figure.

A screw hole 47 continuously formed so as to open from the side surface of the block member 4 to the above-described opening 49.
The screw body 5 is screwed using a wrench 100.

Next, FIG. 4 is an external perspective view of the screw member 5 and FIG. 5 is an external perspective view of the plate member 6. Referring to FIG. 3 and FIGS. 4 and 5, a screw portion 51 screwed into the screw hole portion 47 is formed on an outer peripheral surface of the screw body 5.
Are formed. On the left side of the screw portion 51, the neck portion 52 shaped to fit into the cutout portion 64 of the plate member 6 and the continuously formed flange portion 53 have an outer diameter smaller than the root diameter of the screw portion 51. So that they are integrally formed.

A hexagonal hole 5 is provided on the right side of the screw portion 51.
A hexagonal wrench 100 is inserted into the inside and rotated so that it can be screwed into the block member 4.

Referring to FIG. 5, the same components as those already described are denoted by the same reference numerals, description thereof will be omitted, and the non-explained portions will be described. The plate member 6 is formed in the shape as shown. A counterbore 65 is formed around the notch 64 of the plate member 6 so that the flange 53 of the screw body 5 can be positioned. In order to assemble the plate member 6 and the screw member 5 having the above-described configuration to the block member 4, first, the screw member 5 is screwed into the screw hole 47 of the block member 4, and then the plate member is inserted from the bottom of the block member 4. 6 in the direction of arrow D3 so that the U-shaped linear grooves 45 and 46 of the block member 4 and the hinge portions 62 and 63 of the plate member 6 are rotatably fitted, and the neck portion of the screw body 5 is formed. 52 is in a state of infiltrating into the notch 64 of the plate member 6.

Thereafter, as shown in FIG.
Place at 1. As described above, since the fixing mechanism 20 itself can be handled as one unit, the assembly of the connector portion can be performed very easily.

Next, FIG. 6A is a cross-sectional view showing the state of the first state in which the fixing mechanism 20 is in the open state.
(B) is a cross-sectional view showing a state of the second state in which the fixing mechanism 20 is in a pressed state.

First, in FIG. 6A, in the open state, which is the first state, the plate member 6 has the through hole 41,
42, 43, and 44 are formed so as not to be blocked.
More specifically, referring to FIG. 5, a concave portion 68 is formed at the lower portion of plate member 6 and an inclined surface portion 67 is formed at the upper portion, and in this open state, electrode lead 2 can be freely inserted and removed. I can do it. In this state, the screw 5 is unscrewed more than necessary to
Even if it is turned with a wrench so as to remove it from the plate member 7, the surface portion 55 formed between the neck 52 and the flange 53 of the screw body 5 with respect to the counterbore portion 65 provided around the notch portion 64 of the plate member 6. The contact can prevent further rotation of the screw body 5. For this reason, there is no possibility that the screw body 5 is excessively loosened and accidentally pulled out.

Next, in FIG. 6B, the hexagon wrench 100 is inserted into the hexagonal hole 54 provided in the screw body 5 and rotated from the state shown in FIG. As the screw is turned in the tightening direction, the surface portion 54 formed by the neck portion 52 and the screw portion 51 of the screw body 5 (FIG. 4)
(Shown in (a)) pushes the upper part 69 of the plate member 6 backward. As a result, the plate member 6 rotates about the hinges 62 and 63 serving as the pivot portions as the rotation centers, and thereby the through holes 41, 42, 43 and 44 of the block member 4.
The two electrode leads 2 inserted in the
The electrode lead 2 is fixed in a stationary state so as to be sandwiched between the block member and the through hole.

At this time, the width dimension S of the neck portion 52 of the screw body 5 is set to the thickness dimension of the notch portion 64 of the plate member so that the plate member 6 can be rotated by an angle for tightening the electrode lead 2 with an appropriate force. It is slightly larger than T.

With the above configuration, if the screw body 5 is to be tightened more than necessary, the face part 55 formed by the neck part 52 and the flange part 53 of the plate member 6 is formed on the flange part 53 of the screw body 5. The plate member 6 can be brought into contact with the countersunk portion 65, and further rotation of the plate member 6 is restricted.

As a result, excessive rotation of the screw body 5 is prevented, and the electrode lead 2 and the fixing mechanism 2 due to excessive tightening are prevented.
0 itself is prevented from being damaged.

The position where the fixing mechanism 20 tightens the electrode lead 2 is closer to the electrode lead insertion opening 11a of the connector portion 11 than the sealing mechanism 3 for body fluid which is provided in the electrode lead 2 as standard. Since the position where the electrode lead 2 is tightened is usually a portion where an insulating coating layer such as silicone or polyurethane is provided, even if a body fluid enters the portion, a special sealing mechanism is required. There is no need to provide

Again, in FIG. 1, the plate member is provided with a projection 61, and this projection 61 is
0 protrudes from the outer surface of the block member 4 when it is moving to the open state of the first state, while it is the same as the outer surface of the block member 4 when it is in the fixed state of the second state. It has a substantially wedge-shaped shape. With this configuration, it is possible to know the state of the fixing mechanism only by glance from the outside, and it is possible to reduce a sense of discomfort after implantation in the living body.

The block member 4, plate member 6, and screw member 5 need to be made of a material having high biocompatibility such as stainless steel or titanium in order to directly contact the living tissue as described above. . In addition, the structure of the electrode lead 2 in the above-described fixing portion has a strong structure in which a metal tube is usually disposed inside the insulating coating layer, and can withstand a tightening force. However, considering that the insulating coating layer at the fixing portion of the electrode lead 2 is damaged for an unexpected reason, there is a possibility that an electrical short circuit may occur if the plate member 6 is formed of a conductive material.

Therefore, assuming such a situation, at least the plate member 6, preferably the block member 4, and the screw member 5 have high biocompatibility such as parylene on each surface and have electrical insulation. The material may be coated, or all of these members may be formed of a non-conductor, so as to enhance safety.

Further, as shown in FIG. 1, the two electrode lead insertion openings 11a of the connector portion 11 are arranged so that the insertion openings are obliquely shifted with respect to the vertical direction. With this configuration, the outer shape of the connector portion 11 can be reduced in size, and at the same time, the two electrode leads 2 when the plate member 6 rotates due to the mutual positional relationship with the inclined surface 67 of the plate member 6 can be reduced. The amount of tightening, which is the pressing force, can be made equal.

According to the above embodiment, the fixing mechanism 2
0 has been described as being configured separately from the connector portion 11, but is not limited thereto. For example, a shape portion corresponding to a block member is integrally formed with the connector portion 11, and a plate member, It goes without saying that the above-described operation can be realized even when the screw body is configured to be assembled.

As described above, the fixing mechanism 2 is located at a position closer to the electrode lead connector insertion opening 11a of the connector portion 11 than the position of the liquid seal 3 provided as standard on the electrode lead.
By setting 0, a plurality of electrode leads 2 can be securely fixed mechanically by one operation,
It is possible to provide a positive prevention mechanism for preventing the screw body 5 from coming off or overtightening, and it is not necessary to separately provide a seal mechanism for infiltration of body fluid. Therefore, by applying the electrode attaching / detaching device of the implantable device to the electrode lead of the cardiac pacemaker, the fixing operation can be simplified and highly reliable, and the operation time can be greatly reduced.

[0043]

As described above, according to the electrode attaching / detaching device of the in-vivo implanting device according to the present invention, the operation for mechanically fixing the electrode lead can be greatly simplified, and the reliability after fixing is improved. Thus, there is an effect that the electrode lead can be maintained at a high level and the electrode lead can be positively prevented from being damaged due to an erroneous operation during operation.

[0044]

[Brief description of the drawings]

FIG. 1 is an external perspective view of a connector section 11 of an in-vivo implant device 1 as viewed obliquely from above.

FIG. 2 is an external perspective view seen from obliquely rearward above after fixing electrode leads.

FIG. 3 is a three-dimensional exploded view of the fixing mechanism viewed from obliquely below.

FIG. 4 is an external perspective view of a screw member 5 of a holding member which is a main component.

FIG. 5 shows a plate member 6 of a pressing member which is a main component.
It is an external appearance perspective view of.

6A is a cross-sectional view showing a state of a first state in which the fixing mechanism 20 is in an open state, and FIG.
FIG. 9 is a cross-sectional view showing a second state where 0 is a pressed state.

FIG. 7 is a fragmentary sectional view showing a conventional fixing mechanism.

8 is a sectional view taken along the line AA of FIG. 7;

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Whole apparatus 2 Electrode lead 3 Body fluid seal part 4 Block member 5 Screw body (holding member) 6 Plate member (pressing member) 10 Device 11 Connector part 11a Insertion hole part 20 Fixing mechanism

Claims (6)

[Claims] 1. An electrode attaching / detaching device for a living body implanting device, wherein a plurality of electrode leads detachably connected to the living body implanting device are inserted / removed through insertion holes and held in a liquid-tight state. A connector that is rotatably provided around an axis parallel to a longitudinal direction of the electrode lead, and simultaneously presses the plurality of electrode leads in a first state separated from an outer peripheral surface of the plurality of electrode leads. A living body implanting device comprising: a pressing member that is moved to a second state; and a holding member that holds the pressing member in one of the first state and the second state. Electrode attachment / detachment device. 2. An electrode attaching / detaching device for a living body implanting device, wherein a plurality of electrode leads detachably connected to the living body implanting device are inserted / removed through insertion holes and held in a liquid-tight state. A connector that is rotatably provided around an axis parallel to a longitudinal direction of the electrode lead, and simultaneously presses the plurality of electrode leads in a first state separated from an outer peripheral surface of the plurality of electrode leads. A pressing member that is moved to a second state, a holding member that holds the pressing member in one of the first state and the second state, and a through-hole that penetrates the electrode lead. With
An electrode attaching / detaching device for a living body implanting device, comprising: a block member that incorporates the pressing member and the holding member and is fixed to the connector portion. 3. The liquid crystal device according to claim 1, wherein the pressing member is disposed at a position closer to the insertion hole side than a position of a liquid seal portion disposed to bring the electrode lead into the liquid-tight state. An electrode attachment / detachment device for the in-vivo implant device according to claim 1. 4. The block member includes a plurality of through holes for individually inserting and removing the electrode leads, and a screw hole penetrating outward in a direction substantially orthogonal to an inner diameter surface of the through hole.
And a bearing portion for pivotally supporting the pressing member in the opening portion, wherein the holding member is screwed into the screw hole portion,
A neck portion sunk into a notch portion formed in the pressing member and a flange portion continuously formed from the neck portion; and a thickness dimension of the notch portion of the pressing member is set to the neck. 4. The electrode attaching / detaching device for an implantable living body according to claim 2, wherein the width is set to be larger than the width of the part by a predetermined amount. 5. The electrode according to claim 1, wherein the pressing member has a protruding portion that protrudes outside from the opening of the block member. apparatus. . 6. Any or all of the block member, the pressing member, and the holding member are formed of an electrical insulator, or are surface-coated with an electrical insulator and are electrically non-conductive. The electrode attaching / detaching device of the in-vivo implanting device according to claim 2, wherein the device is configured.