JPH09253220A - Lead implantable in vivo - Google Patents

Abstract

PROBLEM TO BE SOLVED: To enable accurately positioning and fixing of a lead body with a simple operation. SOLUTION: This lead includes a long-sized lead body 20 covered with a vitally compatible polymer, through which an electric conductor is inserted and a suturing sleeve 26 movable along the length of the lead body 20 on the circumference of at least a part in the longitudinal direction of the lead body 20. The suturing sleeve 26 at a natural position has an inner diameter thereof larger than the outer diameter of at least a part of the lead body 20 and is provided with a coil 50. The coil contracts down to the previously prescribed inner diameter by a feather touch operation to fix the suturing sleeve 26 by clamping a part of the lead body 20 by a specified stress.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to an in-vivo implantable lead for use with a cardiac pacemaker or an implantable defibrillator. The present invention relates to a lead that has a suture sleeve that is indirectly fixed and that minimizes movement of the lead due to biological movement.

[0002]

BACKGROUND OF THE INVENTION Many implantable leads are known in the prior art for use with cardiac pacemakers and implantable defibrillators. Generally, a lead includes at least one electrode for electrically stimulating the heart or sensing electrical excitation of the heart, and an electrical connector for making an electrical connection to a cardiac pacemaker or implantable defibrillator. A lead body that connects an electrode and an electrical connector by wrapping an electrical conductor for transmitting an electrical signal between the electrode and a cardiac pacemaker or implantable defibrillator with a biocompatible insulating coating. ing.
In particular, in transvenous leads, electrodes and parts of the lead body are inserted into the heart and veins, and the rest of the lead body that is not inserted into the veins and electrical connectors are placed outside the vein of a cardiac pacemaker or implantable device. Extends to the defibrillator connection housing. The electrodes of the transvenous lead need to be inserted and maintained in place within the heart in order to achieve full system performance. Therefore, generally, a transvenous lead is provided with a suture sleeve that is movable on the lead body along the longitudinal direction thereof, and the suture sleeve is suture-fixed to the living tissue together with the lead body in the vicinity of the blood vessel insertion portion of the lead body. However, it prevents the electrodes from being displaced or coming off. A conventional suture sleeve is a basically cylindrical molded product made of a biocompatible elastic polymer material such as silicone rubber. Two to four grooves are provided around the cylinder, and the groove is formed in the groove. The inner lead body is tightened by tying it along with a suture to achieve the fixation of the suture sleeve and the lead body.

[0003]

However, in such a conventional suture sleeve, since the material is flexible, when the outer peripheral portion of the suture sleeve is tied with the suture thread, the lead is provided through the suture sleeve. The stress applied to the body is difficult to relax, and the suture force is directly transmitted to the lead body. Therefore, when the outer peripheral portion of the suture sleeve is bound with an excessive tightening force, chronic stress is applied locally to the insulation coating of the lead body and the electric conductor that is generally formed in a coil shape, and due to body movement and the like. The tensile stress in the longitudinal direction of the lead acts to cause breakage or crack of the lead insulating coating or breakage of the electric conductor during the implantation period,
There is a problem that lead failure may occur.

Therefore, the present invention has been made in view of the above-mentioned problems, and an object thereof is a lead that can be implanted in a living body that enables reliable positioning and fixing of the lead body by a simple operation. To provide.

[0005]

In order to solve the above-mentioned problems and achieve the object, a lead implantable in a living body according to the present invention is made of a biocompatible polymer material having an electric conductor inserted therein. An elongated lead body that is covered and a suture sleeve that is movable around at least a portion of the lead body in the longitudinal direction along the longitudinal direction of the lead body, and the suture sleeve is in a natural state. In which the inner diameter of the lead body is larger than the outer diameter of at least a part of the lead body, and the lead body contracts to a predetermined inner diameter by one-touch operation, and a part of the lead body is tightened with a predetermined stress to secure the suture sleeve to the lead body. It is characterized in that it is provided with a locking means for fixing to.

In the lead implantable in a living body according to the present invention, the locking means includes a plate coil wound in a cylindrical shape, and the plate coil is at least one of the lead bodies in a natural state. The inner diameter is larger than the outer diameter of the portion.

Further, in the lead implantable in a living body according to the present invention, the plate-shaped coil is wound up by the one-touch operation so that the inner diameter is contracted, and the lead body is tightened.

Further, in the lead implantable in the living body according to the present invention, the one-touch operation is a rotation operation about the longitudinal axis of the suture sleeve.

Further, in the lead implantable in the living body according to the present invention, the plate coil is made of any one of stainless steel, cobalt chrome alloy, tantalum, titanium and titanium alloy. I am trying.

Further, in the lead implantable in the living body according to the present invention, the plate coil is formed of a biocompatible polymer material.

The lead implantable in a living body according to the present invention includes an elongated lead body having an electric conductor inserted therein and covered with a biocompatible polymer material, and a longitudinal direction of the lead body. A suture sleeve movable around at least a part of the lead body along the longitudinal direction of the lead body, the suture sleeve tightening at least a part of the lead body in a natural state with a predetermined stress to perform a one-touch operation. Is provided with a lock releasing means for expanding the diameter to a predetermined inner diameter so as to move the suture sleeve with respect to the lead body.

Further, in the lead implantable in a living body according to the present invention, the lock releasing means includes a plate coil wound in a cylindrical shape, and the plate coil is at least the lead body in a natural state. It is characterized by having an inner diameter smaller than a part of the outer diameter.

Further, in the lead implantable in a living body according to the present invention, the plate-shaped coil is loosened by the one-touch operation so that the inner diameter is enlarged and the tightening of the lead body is released. There is.

Further, in the lead implantable in a living body according to the present invention, the one-touch operation is a rotation operation centering on a longitudinal axis of the suture sleeve.

Further, in the lead implantable in a living body according to the present invention, the plate coil is made of any one of stainless steel, cobalt chrome alloy, tantalum, titanium and titanium alloy. I am trying.

Further, in the lead implantable in the living body according to the present invention, the plate coil is formed of a biocompatible polymer material.

According to the above construction, not only the lead body can be surely positioned and fixed by a simple operation, but also the one-touch locking means is adopted.
The risk of overloading the lead body that exceeds a pre-specified stress can be avoided, and the stress on the lead body can be dispersed over a relatively wide range, improving local concentration of stress. It is possible to avoid the occurrence of lead failure in.

[0018]

Preferred embodiments of the present invention will be described below in detail with reference to the accompanying drawings.

(First Embodiment) FIG. 1 shows a first embodiment of the present invention.
FIG. 2 is a plan view of a lead implantable in a living body according to the embodiment of FIG. 2, FIG. 2 is a longitudinal sectional view showing the structure of the suture sleeve, and FIGS. 3 to 5 are views showing how to use the suture sleeve.

In this embodiment, the suture sleeve 26
As shown in FIG. 2, the first inner cylinder member 32, the first outer cylinder member 34, the second inner cylinder member 36, the second outer cylinder member 38, the cylindrical member 40, The coil 50 is formed by winding a plate-shaped wire into a coil.

The coil 50 is preferably 0.2-10 m
It is a coil of a thin sheet of high-elasticity alloy with a width of m.
Generally 0.1 to 0.1 inserted in the lead body 20.
In order to prevent the metal wire having a diameter of 0.2 mm from biting into the wire gap of the electric conductor wound in close contact with the coil, the width is sufficiently larger than the coil pitch of the electric conductor. The end surface of the thin plate which is the wire of the coil 50 is chamfered so as not to damage the lead body 20. As shown in FIG. 3, which is a cross-sectional view taken along the line AA of FIG. 2, the initial inner diameter of the coil 50 is larger than the outer diameter of the lead body 20, and the lead body 20 is free when the lead body 20 is inserted into the coil 50. It is set to be movable.

As shown in FIG. 2, both ends of the coil 50 are fixed to the first inner cylinder member 32 and the second inner cylinder member 36. First inner cylinder member 32 and second inner cylinder member 36
Examples of the material for forming the resin include hard resin such as PTFE. First inner cylinder member 32 and second inner cylinder member 3
A cylindrical member 40 is fitted at an intermediate position on the outer circumference of 6. The cylindrical member 40 includes a first inner cylindrical member 32, a first inner cylindrical member 32, and a first inner cylindrical member 32.
The outer cylinder member 34, the second inner cylinder member 36, and the second outer cylinder member 38 are slidable in the rotational direction. Examples of the material forming the cylindrical member 40 include biocompatible materials such as silicone and polyurethane. Furthermore, the first inner cylinder member 3
The outer circumference of 2 is covered by the first outer cylinder member 34, and the outer circumference of the second inner cylinder member 36 is covered by the second outer cylinder member 38.
Strongly adhered or mechanically bonded to each other. First
Examples of the material forming the outer cylinder member 34 and the second outer cylinder member 38 include biocompatible materials such as silicone and polyurethane.

As shown in FIG. 4, which is a sectional view taken along the line AA of FIG. 2, the first outer cylinder member 34 is fixed and the second outer cylinder member 3 is fixed.
By rotating 8 (not shown) in the direction of arrow B,
At the same time, with respect to the first inner cylinder member 32, the second inner cylinder member 36
Since the coil (not shown) rotates in the direction of arrow B, the coil 5
The inner diameter of 0 contracts and the lead body 20 is tightened on the entire inner surface of the coil 50.
Fixed to 0. A wing portion 80 is formed on the outer peripheral portion of the second outer tubular member 38 to facilitate rotation of the second outer tubular member 38. Also, as shown in FIG.
Saw-shaped irregularities 70 that mesh with each other are formed at the joint portion of the first inner cylinder member 32 and the second inner cylinder member 36, and the suture sleeve 26 is tightened with a tightening stress that is defined in advance by the meshing pitch. It is fixed to the lead body 20, and the fixed position is held by engagement.

As a clinical application example, the electrode 22, the lead body 20 is cut from the incision of the blood vessel exposed by the incision method.
Insert The suture sleeve 26 has grooves 60, 62 on the outer circumference.
Is inserted until it is located inside the blood vessel, and is sewn together with the blood vessel along the grooves 60, 62 on the outer circumference. At this point, the outer groove 6
Since the first inner cylinder member 32 formed of a hard member is located on the inner surfaces of the lead wires 0 and 62, the movement of the lead body 20 is not hindered by the strong suture, and the stimulation threshold value and the sensing sensitivity are obtained. It is possible to position the electrode optimally for good positioning. At the optimum electrode position, the first
The outer sleeve member 34 is supported and the second outer sleeve member 38 is rotated in the direction in which the coil 50 is tightened, whereby the suture sleeve 26 is fixed to the lead body 20. again,
When the electrode position is adjusted, the suture sleeve 26 is supported by supporting the first outer cylinder member 34, temporarily pulling the second outer cylinder member 38 in the longitudinal direction, and then rotating the coil 50 in the loosening direction. The lead body 20 is again movable inside the inside. Then, after adjusting the electrode position, the suture sleeve 26 is again rotated by rotating the lead body 20.
Then, the surrounding tissue and the suture sleeve 26 are finally sutured along the grooves 64 and 66 on the outer circumference, whereby the lead body 20, the suture sleeve 26 and the surrounding tissue are securely fixed.

(Second Embodiment) FIG. 6 shows a second embodiment of the present invention.
FIG. 9 is a plan view of a lead implantable in a living body according to the embodiment of FIG. 7, FIG. 7 is a longitudinal sectional view showing the structure of the suture sleeve, and FIGS. 8 to 10 are views showing a method of using the suture sleeve.

In this embodiment, the suture sleeve 27 is used.
As shown in FIG. 7, a first inner cylinder member 31, a first outer cylinder member 33, a second inner cylinder member 35, a second outer cylinder member 37, a cylindrical member 41, The coil 51 is formed by winding a plate-shaped element wire in a coil shape.

The coil 51 is preferably 0.2 to 10 m
It is a coil of a thin sheet of high-elasticity alloy with a width of m.
Generally 0.1 to 0.1 inserted in the lead body 20.
In order to prevent the metal wire having a diameter of 0.2 mm from biting into the wire gap of the electric conductor wound in close contact with the coil, the width is sufficiently larger than the coil pitch of the electric conductor. The end surface of the thin plate, which is the strand of the coil 51, is chamfered so as not to damage the lead body 20. As shown in FIG. 8 which is a sectional view taken along line CC of FIG. 7, the initial inner diameter of the coil 51 is fixed to the lead body 20 with the suture sleeve 27 in a state where the lead body 20 is inserted inside the suture sleeve 27. Is set.

As shown in FIG. 7, both ends of the coil 51 are fixed to the first inner cylinder member 31 and the second inner cylinder member 35. First inner cylinder member 31 and second inner cylinder member 35
Examples of the material for forming the resin include hard resin such as PTFE. First inner cylinder member 31 and second inner cylinder member 3
A cylindrical member 41 is fitted at an intermediate position on the outer circumference of 5. The cylindrical member 41 includes the first inner cylinder member 31, the first inner cylinder member 31,
The outer cylinder member 33, the second inner cylinder member 35, and the second outer cylinder member 37 are slidable in the rotational direction. Examples of the material forming the cylindrical member 41 include biocompatible materials such as silicone and polyurethane. Furthermore, the first inner cylinder member 3
The outer circumference of 1 is covered with the first outer cylinder member 33, and the outer circumference of the second inner cylinder member 35 is covered with the second outer cylinder member 37.
Strongly adhered or mechanically bonded to each other. First
Examples of the material for forming the outer cylinder member 33 and the second outer cylinder member 37 include biocompatible materials such as silicone and polyurethane.

As shown in FIG. 9 which is a sectional view taken along line CC of FIG. 7, the first outer cylinder member 33 is fixed and the second outer cylinder member 3 is fixed.
By rotating 7 (not shown) in the direction of arrow D,
At the same time, with respect to the first inner cylinder member 31, the second inner cylinder member 35
Since the coil (not shown) rotates in the direction of arrow D, the coil 5
The inner diameter of 1 is expanded, and the lead body 20 is movable inside the suture sleeve 27. A wing portion 81 is formed on the outer peripheral portion of the second outer cylinder member 37 so that the second outer cylinder member 37 can be easily rotated. Further, as shown in FIG. 10, saw-toothed concavities and convexities 71 that engage with each other are formed at the joint portion of the first inner tubular member 31 and the second inner tubular member 35, and the inner side of the suture sleeve 27 is engaged by the engagement. The lead body 20 is kept movable.

As a clinical application example, from the incision of the blood vessel exposed by the incision method to the electrode 22 and the lead body 20.
Insert The suture sleeve 27 needs to hold the inside of the suture sleeve 27 in advance so that the lead body 20 can move. The suture sleeve 27 is inserted until the outer circumferential grooves 61 and 63 are located inside the blood vessel, and is stitched together with the blood vessel along the outer circumferential grooves 61 and 63. At this point, since the first inner cylinder member 31 formed of a hard member is located on the inner surfaces of the outer peripheral grooves 61 and 63, the movement of the lead body 20 is not hindered by the strong stitching. Therefore, it is possible to perform optimal electrode positioning that provides good stimulation threshold and sensing sensitivity. At the optimum electrode position, the first outer cylinder member 33 is supported, and once the second outer cylinder member 37 is pulled in the longitudinal direction, the lock due to the saw-toothed concavo-convex shape 71 is released, and the coil 51 becomes the initial inner diameter. The suture sleeve 27 is fixed to the lead body 20 by the action of the returning force. When the electrode position is adjusted again, the lead body 20 becomes movable again inside the suture sleeve 27 by supporting the first outer cylinder member 33 and rotating the coil 51 in the loosening direction. . Then, after adjusting the electrode position, the lock by engagement is released again to fix the suture sleeve 27 to the lead body 20, and finally the surrounding tissue and the suture sleeve 27 are sutured along the grooves 65 and 67 on the outer circumference. The lead body 20, the suture sleeve 27, and the surrounding tissue are securely fixed.

The present invention can be applied to a modified or modified version of the above embodiment without departing from the spirit of the invention.

For example, in the above embodiment, the coils 50,
Although a metal material is used for 51, it goes without saying that a biocompatible polymer material may be used.

[0033]

As described above, according to the present invention, not only the lead can be surely positioned and fixed by a simple operation, but also the one-touch locking means is adopted, so that the overload exceeding the predetermined stress can be achieved. The risk of being added to the lead body can be avoided, and the local concentration of stress is improved by distributing the stress to the lead body in a relatively wide range, so that lead failure at the suture sleeve part can be avoided. Becomes

[0034]

[Brief description of drawings]

FIG. 1 is a plan view of a lead implantable in a living body according to a first embodiment of the present invention.

FIG. 2 is a longitudinal sectional view showing the structure of a suture sleeve.

FIG. 3 is a view showing a method of using the suture sleeve.

FIG. 4 is a view showing a method of using the suture sleeve.

FIG. 5 is a view showing a method of using the suture sleeve.

FIG. 6 is a plan view of a lead implantable in a living body according to the second embodiment of the present invention.

FIG. 7 is a longitudinal sectional view showing the structure of the suture sleeve.

FIG. 8 is a view showing a method of using the suture sleeve.

FIG. 9 is a view showing a method of using the suture sleeve.

FIG. 10 is a view showing a method of using the suture sleeve.

[Explanation of symbols]

 20 lead body 22 electrode 24 connector 26, 27 stitching sleeve 31, 32 first inner cylinder member 33, 34 first outer cylinder member 35, 36 second inner cylinder member 37, 38 second outer cylinder member 40, 41 cylindrical member 50, 51 coil 60, 61, 62, 63, 64, 65, 66, 67 groove 70, 71 unevenness

Claims (12)

[Claims] 1. A long lead body having an electric conductor inserted therein and covered with a biocompatible polymer material, and a longitudinal direction of the lead body around at least a part of the lead body in the longitudinal direction. A sewn sleeve movable along the sewn sleeve, the sewn sleeve having an inner diameter larger than an outer diameter of at least a part of the lead body in a natural state, and contracted to a predetermined inner diameter by one-touch operation,
A lead implantable in a living body, comprising locking means for fastening a part of the lead body with a predetermined stress to fix the suture sleeve to the lead body. 2. The locking means includes a plate coil wound in a cylindrical shape, and the plate coil has an inner diameter larger than an outer diameter of at least a part of the lead body in a natural state. The lead implantable in the living body according to claim 1. 3. The lead implantable in a living body according to claim 2, wherein the plate-shaped coil is wound up by the one-touch operation and the inner diameter is contracted to tighten the lead body. 4. The lead implantable in a living body according to claim 3, wherein the one-touch operation is a rotation operation centering on a longitudinal axis of the suture sleeve. 5. The implantable body according to claim 2, wherein the plate-shaped coil is made of a metal material selected from stainless steel, a cobalt chromium alloy, tantalum, titanium, and a titanium alloy. Good lead. 6. The lead implantable in a living body according to claim 2, wherein the plate-shaped coil is made of a biocompatible polymer material. 7. An elongated lead body having an electric conductor inserted therein and covered with a biocompatible polymer material, and a longitudinal direction of the lead body around at least part of the longitudinal direction of the lead body. And a suture sleeve movable along the suture sleeve. The suture sleeve tightens at least a part of the lead body in a natural state with a predetermined stress, expands the inner diameter to a predetermined inner diameter by one-touch operation, and A lead implantable in a living body, comprising lock releasing means for moving a sleeve with respect to the lead body. 8. The unlocking means comprises a plate coil wound in a cylindrical shape, and the plate coil has an inner diameter smaller than an outer diameter of at least a part of the lead body in a natural state. The lead which can be implanted in a living body according to claim 7. 9. The implantable body according to claim 8, wherein the one-touch operation loosens the winding of the plate-shaped coil to increase the inner diameter thereof, thereby releasing the tightening of the lead body. Reed. 10. The lead implantable in a living body according to claim 9, wherein the one-touch operation is a rotation operation centering on a longitudinal axis of the suture sleeve. 11. The implantable body according to claim 8, wherein the plate-shaped coil is made of a metal material of any one of stainless steel, cobalt chrome alloy, tantalum, titanium, and titanium alloy. Good lead. 12. The lead implantable in a living body according to claim 8, wherein the plate-shaped coil is made of a biocompatible polymer material.