JP2002512096A - Intracardiac lead system - Google Patents

Abstract

A heart with an elongated body having a first defibrillation coil electrode (40), a second defibrillation coil electrode (44) and a first pacing / sensing electrode (42). Inner lead (20). The first defibrillation coil electrode has a first end at or near the distal end of the elongated body and a second end longitudinally spaced from the distal end. The first pacing / sensing electrode (42) is longitudinally spaced from the second end of the first defibrillation coil electrode along the outer peripheral surface and includes It is arranged on a curved part. The second defibrillation coil electrode is longitudinally spaced from the first pacing / sensing electrode along the outer peripheral surface, thereby connecting the first defibrillation coil electrode to the right ventricle ( 50), the first pacing / sensing electrode is located in the right ventricle, and the second defibrillation coil electrode (44) is located in the right atrium (52). Or within the vena cava (54) leading to the right atrium.

Description

DETAILED DESCRIPTION OF THE INVENTION

TECHNICAL FIELD The present invention relates to medical devices, and more particularly, to implantable intracardiac catheters for use with medical devices.

BACKGROUND OF THE INVENTION [0002] Ventricular fibrillation of the heart is characterized by the fact that the ventricular muscles perform fine and fast fibrillation instead of the normal contraction of the heart. Pumping action (pu) during ventricular fibrillation
Since there is very little pinging action, a fatal situation would result if not immediately treated by a cardiac conversion. During conversion, the myocardial tissue of the heart is depolarized (d
The defibrillation level of electrical energy is applied to the heart so that it can be epolized to re-establish normal sinus rhythm.

[0003] One theory proposed to explain the mechanism of conversion by the application of a defibrillation current is based on the critical mass hypothesis.
is). The critical mass hypothesis is that it is not necessary to stop all defibrillation movements in performing defibrillation, and it is sufficient to stop only the "critical mass (about 75%)" of the ventricular myocardium. It suggests. In this theory, if all fibrillation is localized to an area smaller than the critical mass of the myocardium, the remaining fibrillation will not be able to maintain fibrillation and will disappear after one or two heartbeats, It is assumed that it will result in normal sinus rhythm.

[0004] Implantable cardioverter / defibrillators (ICDs) have been successfully used to treat patients who have experienced at least one hemodynamically significant ventricular tachycardia or ventricular fibrillation. It has been. The basic ICD consists of a main battery, electronic circuitry that controls both the sensing of the patient's heart signal and the delivery of an electric shock to the patient's heart, and a high voltage housed in a sealed titanium case. And a capacitor row. One or more catheter leads having defibrillation electrodes are then implanted within the patient's heart or on the epicardial surface of the patient's heart. In addition, the catheter lead is connected to the implantable housing and electronics of the ICD and used to deliver defibrillation-level electrical energy to the heart.

[0005] Effective cardiac defibrillation requires that defibrillation-level shocks generate a minimum and even (ie, the same in all parts of the ventricle) potential gradient. This potential gradient is influenced and determined by the voltage of the shock and the shape of the electrodes used. It has also been suggested that a maximum potential gradient exists, above which detrimental electrophysiological and physical effects such as new arrhythmias, myocardial necrosis, or contractile heart failure can occur. . Thus, how and where the defibrillation electrode is placed on and / or within the heart
Significantly affects whether critical mass of heart tissue is captured during a defibrillation attempt.

[0006] Intracardiac defibrillation catheters that do not require a thoracotomy on the heart offer significant advantages over epicardial lead systems due to reduced morbidity, mortality, and cost of the thoracotomy procedure. Having. However, a significant problem with these systems is the potential at a higher defibrillation threshold compared to systems using epicardial defibrillation electrodes. However, changing the waveform of the defibrillation shock and the combination of the intracardiac lead implanted in the patient and the current path used can provide the patient with an effective defibrillation therapy. become.

[0007] The easiest and most convenient approach to performing a full transvenous implantation uses a single intracardiac lead with both sensing and pacing and defibrillation features. That is. Such an intracardiac lead is an ENDOTAK
C (Cardiac Pacemaker, In, St. Paul, MN)
c. / Guidant Corporation). This intracardiac lead leads to the electrocardiographic velocity of the right ventricle in the heart.
Triode tinned featuring one porous tip electrode (located at the apex of the right ventricle) and two defibrillation coil electrodes that function as a cathode for sensing and pacing A) a lead wire, the distal defibrillation coil electrode serving as an anode for velocity detection and as a cathode for morphology detection and defibrillation, and a proximal side disposed in the superior vena cava Function as an anode for defibrillation.

[0008] However, it has been reported that a single intracardiac lead used for both defibrillation and speed sensing is technically inadequate because it puts the patient at great risk. I have. Also, the effects of the electrocardiogram obtained from the integrated lead for sensing / pacing and defibrillation after the application of a shock are seen, so that the intensity of the shock is such that the risk of arrhythmia recurrence (redetection) is at risk. Can be lowered. As already mentioned above, obtaining an adequate defibrillation threshold is a significant problem with non-thoracoscopic intracardiac lead systems. Thus, there is a need to design an intracardiac lead system that effectively lowers the defibrillation threshold and ensures detection and pacing after a defibrillation shock.

SUMMARY OF THE INVENTION The present invention is directed to a single intracardiac lead for lowering defibrillation thresholds and improving arrhythmia recurrence after defibrillation shock therapy, and an implantable device for using the same. provide. One aspect of these improvements resides in placing each electrode on an intracardiac lead. Electrode geometry on the intracardiac lead improves the potential gradient created by defibrillation-level shocks, which increases the effectiveness of cardioversion shock and reduces cardioversion compared to conventional intracardiac leads. Lowers fibrillation threshold. Also, the position of the pacing electrode relative to the defibrillation electrode provides a more reliable and accurate post-shock electrogram. In addition, the lower defibrillation threshold reduces the battery consumption of the implantable device,
It is possible to extend the life of the device as much as possible and / or reduce the size of the device as a whole.

[0010] The intracardiac lead of the present invention comprises an elongated body having an outer peripheral surface, a proximal end, and a distal end, and a first defibrillation coil electrode and a first pacing / sensing electrode on the outer peripheral surface. Have. The first defibrillation coil electrode is disposed on the intracardiac lead at or near a distal end of the elongated body. The first pacing /
The sensing electrode is longitudinally spaced along the outer circumference from the first defibrillation coil electrode, such that the first defibrillation coil and the first pacing / sensing electrode in the right ventricle of the heart. An arrangement is made for both. In one embodiment, the intracardiac lead is located in the right ventricle of the heart and the first defibrillation coil electrode is longitudinally positioned proximate the right ventricular septum. In an additional embodiment, the intracardiac lead is located in the right ventricle of the heart and the first defibrillation coil electrode is located directly in the apex of the ventricle, where the first defibrillation coil electrode is located. The fibrillation coil is longitudinally proximal to the apex of the right ventricle of the heart.

In an additional embodiment of the invention, the intracardiac lead further comprises a second defibrillation coil electrode on the outer peripheral surface. The second defibrillation coil electrode is longitudinally spaced from the first pacing / detection electrode along the outer peripheral surface;
This places the first defibrillation coil and the first pacing / sensing electrode in the right ventricle and places the second defibrillation coil in the upper ventricular region of the heart. In one embodiment, the second defibrillation coil electrode is placed in the right atrium or in the vena cava leading to the right atrium of the heart.

Various types and shapes of first pacing / sensing electrodes can be used with the intracardiac lead of the present invention. In one embodiment, the first pacing / sensing electrode is a holding element integrated with or located proximate to the first pacing / sensing electrode. Is provided.
The retention element is implanted within the tissue of the right ventricle of the heart, thereby securing the first pacing / sensing electrode and the elongated body of the intracardiac lead to the right ventricle of the heart. Become like In one embodiment, the retaining element is a helical wire used to secure the first pacing / sensing electrode to cardiac tissue of the ventricular septum.

[0013] In an additional embodiment, the outer peripheral surface of the elongate body defines an electrode housing having an opening, which housing can cover the first pacing / sensing electrode and the holding element. The first pacing / sensing electrode and / or the retaining element extends through the housing to engage the right ventricle of the heart by extending from the outer peripheral surface. A stylet lumen may extend through the elongate body of the intracardiac lead to the first pacing / sensing electrode to receive the stylet, the stylet including the first stylet. The pacing / sensing electrode and the retaining element are used to extend and rotate the retaining element of the first pacing / sensing electrode into the right ventricle of the heart.

[0014] In another embodiment, the elongated body of the intracardiac lead further has a curved portion spaced from the proximal and distal ends. The curved portion has an outer diameter surface and an inner diameter surface, the outer diameter surface generally having a larger radius of curvature than the inner diameter surface. The electrode housing of the first pacing / sensing electrode is adapted to engage the heart tissue by extending the first pacing / sensing electrode beyond the outer peripheral surface of the elongate body. A pacing / sensing electrode is generally disposed on the outer diameter surface of the curved portion so as to be along an axis substantially parallel to the proximal longitudinal axis of the elongated body. In one embodiment, the curved portion forms an angle between about 45-60 degrees with respect to the distal longitudinal axis and the proximal longitudinal axis of the elongate body.

[0015] In another embodiment, the curved elongated body has a first pacing / sensing electrode that is a hemispherical porous woven mesh disposed on the outer peripheral surface of the elongated body. . The porous woven mesh, hemispherical first pacing / sensing electrode generally has a first defibrillation coil electrode that is positioned to the right when the intracardiac lead is implanted in the body. The first pacing / sensing electrode is positioned on the outer diameter surface of the curved portion such that the first pacing / sensing electrode is located at the apex of the ventricle and is in physical contact with the tissue of the right ventricle of the heart. In one embodiment, the first pacing / sensing electrode is located on the septum of the right ventricle of the heart.

In another embodiment, the first pacing / sensing electrode is an annular or semi-annular ring electrode, as is known to those of skill in the art, wherein the ring electrode generally comprises an intracardiac lead. The first defibrillation coil electrode is positioned at the apex of the right ventricle when implanted therein, and the first pacing / sensing electrode is in physical contact with right ventricular tissue of the heart. The curved portion is disposed on the outer diameter surface.

In the drawings, like numbers refer to like elements throughout the several views.

DETAILED DESCRIPTION In the following detailed description, reference is made to the accompanying drawings, which form a part hereof, and in which:
Reference will now be made to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. While these embodiments have been described in sufficient detail to enable those skilled in the art to make and use the invention, other embodiments may be utilized without departing from the spirit and scope of the invention. Clearly, changes may be made electrically, logically and structurally. Therefore, the following detailed description should not be construed in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents.

FIG. 1 illustrates one embodiment of a device 20 having a cardioverter / defibrillator 22 physically and electrically coupled to an intracardiac lead 24. The device 20 is the human body 2
Implanted within 6, a portion of intracardiac lead 24 is inserted into heart 28. This detects and analyzes the electrical heart signal generated by the heart 28, and under certain predetermined conditions to treat ventricular arrhythmias such as ventricular tachycardia and ventricular fibrillation of the heart 28. Electrical energy is provided to 28.

The intracardiac lead 24 includes an elongated body 32 having an outer peripheral surface 34, a proximal end 36, and a distal end 38. Further, the intracardiac lead 24 has one or more defibrillation coil electrodes and one or more pacing / sensing electrodes. In one embodiment, the intracardiac lead 24 includes a first defibrillation coil electrode 40 attached to the outer peripheral surface 34 of the elongated body 32, a first pacing / sensing electrode 42, and a second pacing / sensing electrode 42. Defibrillation coil electrode 44.

In one embodiment, first defibrillation coil electrode 40 and second defibrillation coil electrode 44 are helically wound spring electrodes as known to those skilled in the art. The surface area of the first defibrillation coil electrode 40 and the second defibrillation coil electrode 44 is between 200 and 1,000 square millimeters, and preferably the surface area of the first defibrillation coil electrode 40 is 500 square millimeters. And the second defibrillation coil electrode 44
Has a surface area of 800 square millimeters. In additional embodiments, the first defibrillation coil electrode 40 and the second defibrillation coil electrode 44 have a helical coil diameter of 2.5-4.0 millimeters and a length of 2-4 mm. 6 cm, 3-6 cm, 4-6 cm, 2-4 cm,
Suitable lengths range from 3 to 4 centimeters.

The first defibrillation coil electrode 40 further has a first end 46 and a second end 48. The first end 46 is at or near the distal end 38 of the elongate body 32 and the second end 48 is the first end 46 of the first defibrillation coil electrode 40 and the elongate body 32.
From the distal end 38 along the outer peripheral surface 34. In one embodiment, first end 46 of first defibrillation coil electrode 40 forms part of distal end 38 of elongate body 32. In another embodiment, the first end 46 of the first defibrillation coil electrode 40 is spaced longitudinally from the distal end 38 along the outer peripheral surface 34 by a distance of 0 to 7 millimeters.

The first pacing / sensing electrode 42 is longitudinally spaced from the second end 48 of the first defibrillation coil electrode 40 along the outer peripheral surface 34 by a distance of 1 to 10 centimeters; Preferably it is 1-3 cm. In one embodiment, separating the first defibrillation coil electrode 40 from the first pacing / sensing electrode 42 comprises:
The first defibrillation coil electrode 40 and the first pacing / sensing electrode 42 are
8 in the right ventricle 50. In one embodiment, the first defibrillation coil electrode 40 includes a first defibrillation coil electrode 40 disposed longitudinally adjacent the septum location of the right ventricle 50 of the heart 28 and Pacing / sensing electrode 4
2 is implanted at the distal end of the right ventricle 50 so that it physically contacts the septum of the right ventricle 50.

The second defibrillation coil electrode 44 is longitudinally spaced along the outer peripheral surface 34 from the first pacing / sensing electrode 42 by a distance of 8 to 15 centimeters. In one embodiment, the second defibrillation coil electrode 44 and the first defibrillation coil electrode 40
Separating the second defibrillation coil electrode 44 from the right atrium 52 when the first defibrillation coil electrode 40 and the first pacing / sensing electrode 42 are disposed in the right ventricle 50. Or in the vena cava 54 leading to the right atrium 52. In one embodiment, the vena cava 54 leading to the right atrium 52 of the heart is the superior vena cava.

Next, FIGS. 2 and 3 show one embodiment of the intracardiac lead 24 of the present invention. The first electrical conductor 56 extends from the first contact end 58 at the proximal end 36 to the elongated body 32.
And is electrically connected to the first defibrillation coil electrode 40. Further, a second electrical conductor 60 is shown extending longitudinally within the elongated body 32 from a second contact end 62 at the proximal end 36 and electrically connected to the first pacing / sensing electrode 42. Connected to. Finally, the third conductor 64 is
It is shown extending longitudinally within the elongated body 32 from a third contact end 66 at the proximal end 36 and is electrically connected to the second defibrillation coil electrode 44. In one embodiment, the first contact end 58, the second contact end 62, and the third contact end 6
Reference numeral 6 denotes a cylindrical or solid metal pin made of titanium, stainless steel or MP35N.

The intracardiac lead 24 has at least one stylet lumen extending longitudinally within the elongated body 32. In one embodiment, elongate body 32 has a first stylet lumen 68 and a second stylet lumen 70, and first stylet lumen 68 is a first stylet lumen 68 at proximal end 36. Extending from the inlet end 72 to the distal end 38 of the reticle. The first stylet lumen 68 is adapted to receive a guiding stylet for stiffening and shaping the intracardiac lead 24 during insertion of the intracardiac lead 24 into the heart 28. A second stylet lumen 70 extends from a second entry end 74 at the proximal end 36 to the first pacing / sensing electrode 42. In one embodiment, the second stylet lumen 70 is formed by a second conductor 60 having an elongated helical coil shape as is known to those skilled in the art.

In an additional embodiment, the first pacing / sensing electrode 42 includes a holding element 76
Which is suitable for being implanted in the right ventricle 50 of the heart 28.
Retention element 76 is designed to secure first pacing / sensing electrode 42 of intracardiac lead 24 and elongate body 32 to heart 28. In one embodiment,
Retention element 76 is adapted to secure first pacing / sensing electrode 42 of intracardiac lead 24 and elongate body 32 to an intracardiac location within right ventricle 50 of heart 28.

In one embodiment, retaining element 76 is a straight piece of wire. The straight wire segment has a proximal end and a distal end, the distal end being sharpened toward the point and having a retaining barb. The retaining barb protrudes toward the proximal end of the linear wire at its distal end, spaced from the outer periphery of the linear wire, and engages and is implanted in the heart tissue. I have. In an additional embodiment, the retaining element 76 is a wire shaped into a helical projection having a proximal end and a distal end. In one embodiment, the distal end of the retaining element 76 is sharpened toward a point suitable for engaging and implanting ventricular tissue of the heart. In an additional embodiment, the retaining element 76
Is fixed to the first pacing / sensing electrode by welding the proximal end to the first pacing / sensing electrode. In another embodiment, the proximal end of the retaining element 76 is adapted to frictionally engage the proximal end of the retaining element 76 with the first pacing / sensing electrode 42 to provide the first pacing / sensing electrode 42. Physically fixed to the electrode 42.

In a further embodiment, the retaining element 76 forms part of the first pacing / sensing electrode 42, wherein the wire element protrudes from the outer surface of the first pacing / sensing electrode 42. It extends in a direction away from this outer surface. In an additional embodiment, the helical wire of the retaining element 76 extends around the outer periphery of the first pacing / sensing electrode and extends away from the outer surface of the first pacing / sensing electrode. In another embodiment, the retaining element 76 is a hook-like projection having a sharpened distal end that engages the tissue of the right ventricle of the heart to engage the first pacing / sensing electrode 42 and the elongated body. Used to secure 32 to heart 28.

Referring now to FIGS. 4 and 5, additional embodiments of the intracardiac lead 24 are shown. Here, the elongated body 32 of the intracardiac lead 24 further comprises an arcuate end 80. In one embodiment, the arcuate end 80 curves away from the longitudinal axis of the elongate body 32 to create a “J-tip” at the distal end 38 of the intracardiac lead 24. In another embodiment, the arcuate end 80 curves away from the longitudinal axis of the elongate body 32 to create an "L-cusp" at the distal end 38 of the intracardiac lead 24, in which case the long end is elongated. The distal end 38 of the elongated body 32 is disposed perpendicular to the longitudinal axis of the elongated body 32. The arcuate end 80 is adapted to be located within the right ventricle 50 and adjacent the apex 82 of the right ventricle 50.

In one embodiment, the arcuate end 80 is spaced from the longitudinal axis of the proximal end 36 of the elongated body 32 in a direction opposite to the side on which the first pacing / sensing electrode 42 is located. To be curved. In one embodiment, this configuration of the intracardiac lead 24 allows the first pacing / sensing electrode 42 to be implanted or positioned along the septum 84 of the right ventricle 50. Long body 32 is right ventricle 50
When the elongated body 32 extends downwardly close to the septum 84, the arcuate end 80 begins to curve away from the septum 84 and begin to flex as the elongated body 32 extends downwardly. The arcuate end 80 is suitable for being located at the apex 82 of the right ventricle 50. As a result, the first defibrillation coil electrode 40 is positioned along the inner heart wall 86 at the vertex 82 of the right ventricle 50. Depending on the length of the first defibrillation coil electrode 40, some of this electrode
Extend along the inner heart wall 86 of the right ventricle 50 from the apex 82 of the right ventricle.

In another embodiment, arcuate end 80 is spaced from the longitudinal axis of proximal end 36 of elongated body 32 in a direction perpendicular to the side on which first pacing / sensing electrode 42 is located. To be curved. In an additional embodiment, the arcuate end 80 extends from the longitudinal axis of the proximal end 36 of the elongated body 32 to the side where the first pacing / sensing electrode 42 is disposed on the outer peripheral surface 34 of the elongated body 32. It is curved so as to be spaced in any direction between the opposite direction and the direction perpendicular to this side. In general, this configuration of the intracardiac lead 24 allows the first pacing / sensing electrode 42 to be implanted or positioned along the septum 84 of the right ventricle 50. As the elongate body 32 extends to the apex 82 of the right ventricle 50, the arcuate end 80 moves away from the longitudinal axis of the elongate body 32 along the septum 84 as the elongate body 32 extends downwardly adjacent the septum 84. Begin to bend and flex. The arcuate end 80 is adapted to be located at the apex 82 of the right ventricle 50 so that the first defibrillation coil electrode 40 is in the region of the apex 82 of the right ventricle 50 on both the inner heart wall 86 and the septum 84. Are arranged along. Depending on the length of the first defibrillation coil electrode 40, a portion of this electrode extends from the region of the apex 82 of the right ventricle 50 along the inner heart wall 86 of the right ventricle 50.

In one embodiment for generating the arcuate end 80 of the intracardiac lead 24, the first defibrillation coil electrode 40 has a mechanical bias on the electrode structure.
bias) is formed. In one embodiment, a mechanical bias is applied to the electrode while winding the electrode. In another embodiment, the mechanical bias is created by mechanically deforming the electrode after it has been wound. In another embodiment, the polymeric structure of the elongate body 32 is modified to create an arcuate end 80. In one embodiment, the arcuate end 80 is comprised of a polymeric material that has a high strength with respect to the remainder of the elongated body 32. In another embodiment, arcuate end 80 is molded into elongated body 32 during formation of elongated body 32.

In one embodiment, the curvature of the arcuate end 80 generally matches the curvature of the area of the vertex 82. The radius of this curvature causes the first defibrillation coil electrode 40 and right ventricle 50
Direct contact with the human intracardiac tissue is maximized. Since the shape of the diseased heart can vary considerably, the optimal radius of curvature is determined for each patient.

In one embodiment, the arcuate end 80 has a semicircular shape. In another embodiment, arcuate end 80 has a parabolic shape. In an additional embodiment, the arcuate end 8
0 has a small radius curvature that produces a sharp angular deflection in the elongated body 32 of the intracardiac lead 24. In one embodiment, the radius of curvature forms an angle of about 10-70 with respect to the longitudinal axis of distal end 38 and the longitudinal axis of proximal end 36 of elongate body 32. In another embodiment, the radius of curvature is 0.25-1 centimeter, 1- 1
It is 2 centimeters, 1 to 3 centimeters, preferably about 1 centimeter.

Referring now to FIGS. 6A-6C, additional embodiments of the intracardiac lead 24 are shown. In this case, the outer peripheral surface 34 of the elongated main body 32 further forms an electrode housing 100 having a wall defining a through opening. The electrode housing 100 has a first pacing /
Suitable for covering sensing electrode 42, first pacing / sensing electrode 42 extends through electrode housing 100 and engages right ventricle 50 of heart 28.

In one embodiment, the electrode housing 100 includes an outer peripheral surface 34 of the elongated body 32.
And protrudes away from the outer peripheral surface 34. The electrode housing 100 has a first wall 102, which has an outer periphery until the first wall 102 reaches an upper limit 104 that is parallel to the longitudinal axis of the elongated body 32. It protrudes in an arc shape so as to partially surround the surface 34 and separate from the outer peripheral surface 34. In one embodiment, the cross section of the electrode housing 100 at the upper end 104 of the first wall 102 is partially elliptical.

Further, the electrode housing 100 has a second wall 106, and the second wall 106
Are arranged essentially orthogonal to the first wall 102, the second wall 106 protruding from the upper end 104 of the first wall 102 to a part of the outer peripheral surface 34 of the elongated body 32. . The second wall portion 106 defines an opening 108 that extends through the electrode housing 100, and the opening 108 is formed through the electrode housing 100 through the outer peripheral surface 34 of the elongated main body 32.
Is connected to the opening that passes through. The second conductor 60 extends through an opening in the elongated body 32 and extends into an opening 108 defined by a second wall 106 of the electrode housing 100. In one embodiment, the second wall 106 defines a cylindrical opening 108 through the electrode housing 100.

In one embodiment, the second conductor 60 is connected to the opening 1 of the electrode housing 100.
08 and is electrically connected to the movable element 110. The movable element 110 has an outer surface 112, an inner surface 114, and a peripheral surface 116, which is sealed to the second wall 106 of the opening 108.

In one embodiment, the movable element 110 is positioned in the first position within the opening 108 by a force applied to the inner surface of the sleeve by a guiding stylet inserted through the second stylet lumen 70. Or it is adapted to move longitudinally from a retracted position 118 to a second position or extended position 120 and to rotate on the peripheral surface 116. In this case, the second stylet lumen 70 is used to implant the retaining element 76 of the first pacing / sensing electrode 24 into the right ventricle 50 of the heart 28.
Suitable for receiving a stylet that extends and rotates the first pacing / sensing electrode 42.

The second conductive body 60 is provided at a predetermined position where the second conductive body 60 passes through an opening penetrating the outer peripheral surface 34 of the elongated main body 32 into an opening 108 penetrating the electrode housing 100. 32. In this case, the helical coil configuration of the second conductor 60 allows the conductor to extend like a spring as the movable element 110 moves between the first position 118 and the second position 120. Become like

In one embodiment, first pacing / sensing electrode 42 is movable element 110
Is connected to the outer surface 112. In a first position 118 of the movable element 110, the first pacing / sensing electrode 42 and the holding element 76 are housed in the opening 108 of the electrode housing 100. After the movable element 110 has been advanced to the second position 120, both the retaining element 76 and the first pacing / sensing electrode 42 are predetermined beyond the second wall 106 of the electrode housing 100. Extend for a given distance.
In one embodiment, the preferred predetermined distance is up to 3 centimeters. In one embodiment, the holding element 76 and the first pacing / sensing electrode 4
2 is the second wall 1 in a plane essentially parallel to the longitudinal axis of the elongated body 32.
Extends beyond 06. In another embodiment, the retaining element 76 and the first pacing /
The sensing electrode 42 extends beyond the second wall 106 in a plane that is at an acute angle (less than 90 °) to the longitudinal axis of the elongated body 32.

In an additional embodiment, the elongated body 32 further comprises a plurality of tines 78 at or near the distal end 38. The plurality of tines 78 are circumferentially separated from each other, and further project radially away from the outer peripheral surface 34 toward the base end 36 of the elongated main body 32. In one embodiment, the plurality of tines 78 are comprised of the same material used to make the elongated body 32 of the intracardiac lead 24.

In one embodiment, the elongated body 32 of the intracardiac lead 24 is implantable polyurethane, silicone rubber, or another implantable, flexible, biocompatible material. It is made by extrusion of a polymer material. Proximal end 36 and distal end 38
The length of the elongated body 32 of the intracardiac lead 24 between 60 and 120 centimeters. In an additional embodiment, the diameter of the elongated body 32 is no more than 4 millimeters. The conductors 56, 60 and 64 are made of MP35N nickel-cobalt alloy or other conductor materials known to those skilled in the art. The first defibrillation coil electrode 40, the second defibrillation coil electrode 44, the first pacing / sensing electrode 42, the movable element 110, and the holding element 76 are made of a platinum / iridium alloy, titanium Or made of an implantable metal known to those skilled in the art.

Experimental data has shown that the use of intracardiac leads 24 may reduce the required defibrillation intensity of the patient. That is, in a pig model and a dog model, an intracardiac lead 24 of the present invention and an ENDOTAK (Cardiac Pathmaker, Inc./Guidant Co., St. Paul, Minn.) Were used.
empirical tests were performed on the required defibrillation energy using both intracardiac leads commercially available under the trade name of R.P.R. It has been shown that the demand defibrillation energy supply is reduced by 26%. When the intracardiac lead 24 and the ENDOTAK lead were used in the same animal model, ENDOTAK was used.
22% when using intracardiac lead 24 compared to when using lead
It was shown that only the required average peak current was reduced.

An experimental intracardiac defibrillation system is the MINI II (Cardiac Pathmaker, Inc./Guidant Cor, St. Paul, Minn.).
implantable cardioverter defibrillator / defibrillator, commercially available under the trademark trademark of Cardiac Place, St. Paul, Minn.
maker, Inc. Either a single pass ENDOTAK with a shell electrode to form a defibrillation electrode system, commercially available under the registered trademark / Guidant Corporation, or the intracardiac lead 24 of the present invention. Things. Both leads are approximately 3.4 centimeters in length and 0.279 centimeters (0.110 inch) in diameter on the distal side and 6.8 centimeters in length and 0.279 in diameter on the proximal side. Centimeter (0.110 inc
h) comprised three-packed DBS spring-shock electrodes. END
The OTAK lead had a standard porous tip pacing / sensing electrode with a tip / shock electrode length of about 1.2 cm. Conversely, intracardiac lead 24 has a shock electrode located at the end of elongated body 32, and first pacing / sensing electrode 42 is proximally about 1.2 cm from the shock electrode. Was. In one embodiment, the first pacing / sensing electrode 42 consisted of a small electrode location within a helical coil wound around the outer diameter of the electrode. For the purpose of the experimental procedure, the elongate body 32 further comprises a curved portion, which is disposed between the proximal end 36 and the distal end 38 of the elongate body 32. The curved portion had an outer diameter surface and an inner diameter surface, the outer diameter surface generally having a larger radius of curvature than the inner diameter surface. Since the first pacing / sensing electrode 42 is disposed on the outer diameter surface of the curved portion, the first pacing / sensing electrode 42 is attached to the proximal end 36 of the elongated body 32.
Engaged with the tissue of the heart 28 by extending beyond the outer peripheral surface 34 of the elongate body 32 along an axis essentially parallel to the longitudinal axis of the heart. The curved portion of the intracardiac lead 24 is approximately 60 ° relative to the longitudinal axis of the distal end 38 and the longitudinal axis of the proximal end 36 of the elongated body 32.
The creation of the arc of facilitates partition placement and served as a platform for the first pacing / sensing electrode 42.

The pacing and sensing characteristics and required defibrillation intensity for each lead system were determined in six pigs. Under fluoroscopic guidance, both lead systems were deployed from the apex of the right ventricle to the left external jugular vein. When placed on the ventricular tip, each lead was advanced relative to the septum until the right ventricular shock electrode was placed in the ventral groove of the right ventricular outflow tract. The MINI II shell electrode was implanted subcutaneously in the left chest. The right ventricular shock electrode served as the cathode to attempt defibrillation.

The pacing threshold (0.5 ms pulse width), impedance and sensing characteristics (R-wave amplitude) were determined using a SEAMED external stimulator (Redmond, Washington) prior to the defibrillation trial. The required defibrillation strength (applied energy, peak voltage and peak current) for each lead system is LABVIE
W-directed current amplifiers (National Instrument, Austin, Texas)
ment) using an 80% fixed-gradient biphasic shock.
The defibrillation, pacing threshold and sensing characteristics of the two lead systems were compared using a paired t-test.

The required defibrillation intensity for the intracardiac lead 24 was lower than with the ENDOTAK system. ENDOTAK when applied to TRIAD system
According to the intracardiac lead 24 as compared to the TRIAD system, the applied energy,
The required peak voltage and required peak current are 32%, 17% and 25%, respectively (
p <0.01). Although not statistically significant according to the paired t-test, the pacing and sensing characteristics of the intracardiac lead 24 were different from the ENDOTAK system. The sensed R-wave amplitude, according to intracardiac lead 24, is EN
14% (p> 0.05) lower than the DOTAK system. Pacing
The threshold is 38% (0.3 V, p> 0.05) according to the ENDOTAK passive electrode compared to the small contractible fixed fixed electrode of the intracardiac lead 24 system.
Only low. The impedance of the test lead system for the intracardiac lead 24 was 12% higher than the ENDOTAK system.

FIG. 7 shows an electronic block diagram of the defibrillator / defibrillator 22. The defibrillator / defibrillator 22 includes an electronic control circuit 200,
00 receives a cardiac signal from the heart 28 and applies electrical energy to the heart 28. In one embodiment, the electronic control circuit 200 includes a first defibrillation coil electrode 40, a first pacing / sensing electrode 42, and a second defibrillation electrode mounted on the surface of the intracardiac lead 24. Terminals 202, 204, 20 connected to the coil electrode 44
6 and 208.

The electronic control circuit 200 of the defibrillator / defibrillator 22 is housed and sealed in a housing 210 (FIGS. 1 and 5) suitable for implantation in the human body 26. . In one embodiment, titanium is used for the housing 210, but other biocompatible housing materials known to those skilled in the art may be used. An additional connector block 212 (FIGS. 1 and 5) is attached to the housing 210 of the defibrillator / defibrillator 22 so that the intracardiac lead 24 and the electrodes are electrically defibrillated. It can be physically and electrically attached to the defibrillator / defibrillator 22 and the contained electronic control circuit 200.

The electronic control circuit 200 of the defibrillator / defibrillator 22 includes a programmable microprocessor with a microprocessor 214 and a memory circuit 216.
System. The memory circuit 216 has parameters for various pacing and sensing modes, and further stores data indicative of the cardiac signals received by the electronic control circuit 200. Electronic control circuit 200 and microprocessor 21
A transmission circuit 218 is additionally connected to 4 so that the defibrillator / defibrillator 22 can communicate with the external control unit 220. In one embodiment, the transmission circuit 218 and the external control unit 220 transmit and receive signals and data between the external control unit 220 and the electronic control circuit 200.
For example, a wire loop antenna 222 and a radio frequency remote link known to those skilled in the art may be used. In this manner, program commands and instructions are transferred to the microprocessor 214 of the defibrillator / defibrillator 22 after implantation, and
Cardiac data stored regarding the detected arrhythmia in the heart 28 and the resulting treatment applied to correct the detected arrhythmia is sent from the cardioverter / defibrillator 22 to the external control unit 220. Will be transferred.

In the defibrillator / defibrillator 22 of FIG. 7, the first defibrillation coil electrode 40 and the first pacing / detection electrode 42 are connected to a sense amplifier 224. The output is connected to the R wave detector 226. These components are used to sense and amplify the QRS wave of the heart and provide a signal representing the QRS wave to the microprocessor 214. In particular, microprocessor 214 responds to R-wave detector 226 by providing a pacing signal to pace output circuit 228 when required by the programmed pacing mode. Pace output circuit 228 provides an output pacing signal to terminals 202 and 204, which are connected to first pacing / sensing electrode 42 and first defibrillation coil electrode 40 for bipolar cardiac pacing. You. In another embodiment, pace output circuit 228 includes terminals 202 of defibrillator / defibrillator 22 and housing 21.
0 to provide the output pacing signal, thereby providing a unipolar
ar) Both sensing and unipolar pacing of the heart 28 are provided.

The first defibrillation coil electrode 40 and the second defibrillation coil electrode 44 are connected to a sense amplifier 230 whose output is a cardiac morphology detector (cardi).
ac morphology detector 232. These components are used to sense and amplify the heart rate QRS wave from the ventricular region of the heart 28 and provide a signal representing the QRS wave to the microprocessor 214.
In one embodiment, cardiac morphology detector 232 includes an analog filter that filters the noise of the cardiac signal detected by each electrode. The cardiac signal is then A / D converted to a digital signal before being received by the microprocessor 214.

In particular, the microprocessor 214 provides a pacing signal to the pace output circuit 228 when required by the programmed pacing mode, thereby providing a pacing signal from the sense amplifier 230 utilized by the morphology detector 232. Respond to the QRS wave of the detected heartbeat. Pace output circuit 228 provides an output pacing signal to terminals 202 and 204, which provide first pacing / sensing electrode 42 and first defibrillation coil electrode 40 for bipolar pacing. Or to the first pacing / sensing electrode 42 and the housing 210 for unipolar pacing as described above.

The microprocessor 214 also provides a signal to the defibrillation / defibrillation output circuit 234 in response to the nature of the arrhythmia detected by the defibrillator / defibrillator 22, and By providing the heart 28 with cardioversion or defibrillation electrical energy, it responds to cardiac signals sensed within the heart 28 using intracardiac leads 24. . The power to the defibrillator / defibrillator 22 is
Supplied by an electrochemical battery 236 housed within the defibrillator 22.

In one embodiment, the defibrillation or defibrillation electrical energy pulses applied to the heart 28 may be a monophasic pulse, a biphasic pulse, as is known to those skilled in the art. Or the electrical energy of the polyphasic pulse.
In additional embodiments, the heart is provided with more than one pulse of cardioversion or defibrillation electrical energy, each pulse being applied simultaneously or sequentially. In one embodiment, defibrillation electrical energy is transmitted between first defibrillation coil electrode 40 and second defibrillation coil electrode 44 and housing 210 of defibrillator / defibrillator 22. Is given in between. In a further embodiment, first defibrillation coil electrode 40 is a cathode terminal and second defibrillation coil electrode 44 and housing 210 are anode terminals. In another embodiment, cardioversion or defibrillation electrical energy is applied between a first defibrillation coil electrode 40 and a second defibrillation coil electrode 44, wherein In one embodiment, the first defibrillation coil electrode 40 is a cathode terminal and the second defibrillation coil electrode 44 is an anode terminal. In another embodiment, additional defibrillation electrodes, such as subcutaneous patch electrodes, epicardial defibrillation electrodes, etc., are incorporated into the cardioversion / defibrillator 22 and are thereby added. A path for defibrillation electrical energy is created.

Referring now to FIG. 8, an additional embodiment of the intracardiac lead 24 is shown. Here, the elongated body 32 of the intracardiac lead 24 includes a curved portion 300. The curved portion 300 is disposed between the proximal end 36 and the distal end 38 of the elongated body 32. In one embodiment, curved portion 300 has an outer surface 310 and an inner surface 320, where outer surface 310 has a generally larger radius of curvature than inner surface 320. In an additional embodiment, the electrode housing 100 generally has an outer diameter surface 31 of the curved portion 300.
0. With this configuration, the first pacing / sensing electrode 42 causes the elongated body 3 to extend along an axis that is essentially parallel to the longitudinal axis of the proximal end 36 of the elongated body 32.
The outer peripheral surface 34 extends beyond the outer peripheral surface 34 so that it can engage tissue of the heart 28. In another embodiment, the first pacing / sensing electrode 42 has an outer periphery of the elongate body 32 along an axis having an obtuse angle (greater than 90 °) to the longitudinal axis of the proximal end 36 of the elongate body 32. It extends beyond the surface 34 so that it can engage tissue of the heart 28.

The curved portion 300 of the intracardiac lead 24 forms an angle of about 45-60 ° with the longitudinal axis of the distal end 38 of the elongated body 32 and the longitudinal axis of the proximal end 36. In one embodiment, the curved portion 300 of the elongated body 32 is created by a mechanical bias on one or more of the first conductor 56, the second conductor 60, or the third conductor 64. In an additional embodiment, the polymeric structure of the elongate body 32 is modified to create a curved portion 300. In one embodiment, curved portion 300 is comprised of a polymeric material that has a high strength with respect to the remainder of elongated body 32. In another embodiment, curved portion 300 is molded into elongated body 32 during formation of elongated body 32.

Referring now to FIG. 9, an additional embodiment of the intracardiac lead 24 of the present invention is shown. Intracardiac lead 24 includes an elongated body 32 having an elongated body 32, an outer peripheral surface 34, a proximal end 36, and a distal end 38. Further, intracardiac lead 24 includes one or more defibrillation coil electrodes and one or more pacing / sensing electrodes. In one embodiment, the intracardiac lead 24 includes a first defibrillation coil electrode 40 attached to the outer peripheral surface 34 of the elongated body 32, a first pacing / sensing electrode 400, and a second pacing / sensing electrode 400. Defibrillation coil electrode 44.

In one embodiment, the first defibrillation coil electrode 40 and the second defibrillation coil electrode 44 are helically wound spring electrodes as known to those skilled in the art. First defibrillation coil electrode 40 further includes a first end 46 and a second end 48. The first end 46 is at or near the distal end 38 of the elongate body 32 and the second end 48 is the first end 46 of the first defibrillation coil electrode 40 and the elongate body 3.
The second end 38 is longitudinally spaced along the outer peripheral surface 34. In one embodiment, the first end 46 of the first defibrillation coil electrode 40 is the distal end 38 of the elongated body 32.
Form part of In another embodiment, the first end 4 of the first coil electrode 40
6 is spaced longitudinally from distal end 38 along outer peripheral surface 34 by a distance of 0-7 millimeters.

The first pacing / sensing electrode 400 is longitudinally spaced from the second end 48 of the first defibrillation coil electrode 40 along the outer peripheral surface 34 by a distance of 1 to 10 cm, Preferably it is 1-3 cm. In one embodiment, separating the first defibrillation coil electrode 40 and the first pacing / sensing electrode 400 comprises the first defibrillating coil electrode 40 and the first pacing / sensing electrode. 400 to be placed in the right ventricle 50 of the heart 28. In one embodiment, the first defibrillation coil electrode 40 includes a first defibrillation coil electrode 40 disposed longitudinally proximate a septum location of the right ventricle 50 of the heart 28 and Of the right ventricle 50 is implanted so that the pacing / sensing electrode 400 of FIG. In one embodiment, the pacing electrode is positioned to contact the ventricular septum of the heart. In another embodiment, the first defibrillation coil electrode 40 is positioned such that the first defibrillation coil electrode 40 is longitudinally positioned proximate the apex of the right ventricle 50 of the heart 28 and Of the right ventricle 50
Is implanted directly along the vertex position of the right ventricle 50 so as to make physical contact with the wall of the right ventricle. In one embodiment, the pacing electrode is positioned to contact the ventricular septum of the heart.

The second defibrillation coil electrode 44 is longitudinally spaced along the outer peripheral surface 34 from the first pacing / sensing electrode 400 by a distance of 8 to 15 cm. In one embodiment, the second defibrillation coil electrode 44 and the first defibrillation coil electrode 4
Separating the first defibrillation coil electrode 44 from the right atrium 52 when the first defibrillation coil electrode 40 and the first pacing / sensing electrode 400 are disposed in the right ventricle 50. For placement within the vena cava 54 leading to the right atrium 52.
In one embodiment, the vena cava leading to the right atrium 52 of the heart is the superior vena cava.

FIG. 9 illustrates one embodiment in which the elongated body 32 of the intracardiac lead 24 comprises a curved portion 300. The curved portion 300 is disposed between the proximal end 36 and the distal end 38 of the elongated body 32. The curved portion 300 allows the intracardiac lead 24 to be implanted within the heart 28 and the first pacing / sensing electrode 400
And the intracardiac lead 24, such as the first defibrillation coil electrode 40.
Is located proximate the inner wall of the heart of the right ventricle, where the first defibrillation coil electrode 40 is at the apex of the right ventricle.

The curved portion 300 of the intracardiac lead 24 forms an angle of about 45-60 ° with the longitudinal axis of the distal end 38 of the elongated body 32 and the longitudinal axis of the proximal end 36. In one embodiment, the curved portion 300 of the elongated body 32 is created by a mechanical bias on one or more of the first conductor 56, the second conductor 60, or the third conductor 64. In an additional embodiment, the polymeric structure of the elongate body 32 is modified to create a curved portion 300. In one embodiment, curved portion 300 is comprised of a polymeric material that has a high strength with respect to the remainder of elongated body 32. In another embodiment, curved portion 300 is molded into elongated body 32 during formation of elongated body 32.

In one embodiment, curved portion 300 has an outer surface 310 and an inner surface 320, where outer surface 310 has a generally larger radius of curvature than inner surface 320. The first defibrillation coil electrode 40 generally has an outer diameter surface 3 of the curved portion 300.
10 are arranged. With this configuration, the first pacing / sensing electrode 400 causes the outer peripheral surface 3 of the elongated body 32 to move when the intracardiac lead 24 is positioned within the heart 28.
4 to allow it to engage the tissue of the heart 28. In one embodiment, the first pacing / sensing electrode 400 and the first defibrillation coil electrode 40 include both the first pacing / sensing electrode 400 and the first defibrillation coil electrode 40. The first defibrillation coil electrode 40 is located in the right ventricle and is implanted in the heart such that the first pacing / sensing electrode 400 is located on the apex of the right ventricle and the first pacing / sensing electrode 400 is located on the ventricular septum of the heart. Be included.

In one embodiment, the first pacing / sensing electrode 400 is a porous woven mesh on the outer circumference of the elongated body, as shown in FIG. The porous woven mesh is made of platinum / iridium alloy, titanium, or another implantable metal wire known to those skilled in the art. In one embodiment, the porous woven mesh has a hemispherical shape and is disposed on an outer peripheral surface of the elongated body. In another embodiment, the first pacing / sensing electrode is annular and surrounds the outer periphery of the elongated body. In an additional embodiment, the first pacing / sensing electrode is semi-annular and partially surrounds the outer periphery of the elongated body.

In an additional embodiment, the elongate body further comprises a plurality of tines 78 at or near the distal end 38. The plurality of tines 78 are circumferentially spaced from one another,
Further, it protrudes toward the base end 36 of the elongated main body 32 while being radially separated from the outer peripheral surface 34. In one embodiment, the plurality of tines 78 are connected to the intracardiac lead 2.
It is made of the same material as that used to make the long body 32. In another embodiment, the elongate body 32 of the intracardiac lead 24 includes the tissue ingrowth (i.
Physically or chemically treated to promote n-growth). The in-growth of the tissue ensures that the intracardiac lead 24 is stabilized and retained after being implanted in the heart 28. In one embodiment, a microstructure is formed on the surface of the elongated body 32 by chemical or physical treatment to allow tissue ingrowth.

Referring now to FIGS. 10 and 11, an additional embodiment of the intracardiac lead 24 of the present invention is shown. A first electrical conductor 56 is shown extending longitudinally within the elongated body 32 from a first contact end 58 at the proximal end 36 and a first defibrillation coil electrode 40.
Is electrically connected to Further, a second electrical conductor 60 is shown extending longitudinally within the elongated body 32 from a second contact end 62 at the proximal end 36 and electrically connected to the first pacing / sensing electrode 42. Connected to. Further, the third conductor 64
Is shown extending longitudinally within elongated body 32 from third contact end 66 at proximal end 36 and is electrically connected to second defibrillation coil electrode 44. Finally, the fourth conductor 420 extends longitudinally within the elongated body 32 from the fourth contact end 422 at the base end 36 and is electrically connected to the second pacing electrode 424. In one embodiment, the first contact end 58, the second contact end 62, the third contact end 66, and the fourth contact end 422 are made of titanium, stainless steel or MP3.
It is a cylindrical or solid metal pin made of 5N.

The intracardiac lead 24 has at least one stylet lumen extending longitudinally within the elongated body 32. In one embodiment, elongate body 32 has a first stylet lumen 68 and a second stylet lumen 70, and first stylet lumen 68 is a first stylet lumen 68 at proximal end 36. Extending from the inlet end 72 to the distal end 38 of the reticle. The first stylet lumen 68 is adapted to receive a guiding stylet for stiffening and shaping the intracardiac lead 24 during insertion of the intracardiac lead 24 into the heart 28. In one embodiment, the first stylet lumen 68
Is a fourth conductor 420 having a long spiral coil shape known to those skilled in the art.
Formed by In one embodiment, such an elongated helical coil shape extends longitudinally through elongated body 32 to a point immediately adjacent or proximate to second pacing electrode 424. In this case, the fourth conductor 420 is connected to the second pacing electrode 424. A second stylet lumen 70 extends from a second entry end 74 at the proximal end 36 to the first pacing / sensing electrode 42. The second stylet lumen 70 is formed by a second conductor 60 having a long spiral coil shape as is known to those skilled in the art.

In additional embodiments, first pacing / sensing electrode 42 and second pacing electrode 424 provide bipolar sensing and pacing of heart 28.
In one embodiment, second pacing electrode 424 is an annular ring electrode that extends around the entire outer peripheral surface 34 of elongated body 32. In another embodiment, second pacing electrode 424 is a semi-annular ring that extends only partially around outer circumferential surface 34 of elongate body 32.

Referring now to FIG. 12, a device comprising a defibrillator / defibrillator 22 physically and electrically connected to an intracardiac lead 24 and a second intracardiac lead 450. Twenty additional embodiments have been shown. Device 20 is implanted within human body 26 and portions of intracardiac lead 24 and second intracardiac lead 450 are inserted into heart 28. This detects and analyzes the electrical heart signal generated by the heart 28, and under certain predetermined conditions to treat ventricular arrhythmias such as ventricular tachycardia and ventricular fibrillation of the heart 28. Electrical energy is provided to 28.

The second intracardiac lead 450 has an outer peripheral surface 454, a proximal end 456, and a distal end 458.
And a long main body 452 having the following. Further, second intracardiac lead 450 includes one or more pacing / sensing electrodes. The second intracardiac lead 450 is adapted to be removably attached to the connector block 212 such that the pacing / sensing electrode attached to the outer peripheral surface 454 of the second intracardiac lead 450 is
Housing 210 of Electronic Defibrillator / Defibrillator 22 and Electronic Control Circuit 200
Can be physically and electrically connected to the

In one embodiment, the second intracardiac lead 450 has a distal pacing / sensing electrode 460 attached to the outer peripheral surface 454 of the elongate body 452. In one embodiment, distal pacing / sensing electrode 460 is connected to distal end 45 of elongated body 452.
8 along the outer peripheral surface 454 by a distance of 0-2 cm in the longitudinal direction, preferably 0-1 cm. In one embodiment, distal pacing / sensing electrode 460 is an annular or semi-annular ring electrode disposed on elongated body 452 of second intracardiac lead 450. In another embodiment, distal pacing / sensing electrode 460 is a pointed electrode positioned on distal end 458 of second intracardiac lead 450. Distal pacing / sensing electrode 460 has a contact end located at proximal end 456 that is connected to a first distal electrode conductor that extends longitudinally within elongated body 452 of second intracardiac lead 450. Electronic control circuit 2 via
00 is electrically connected.

In one embodiment, the second intracardiac lead 450 is the left ventricular epicardial surface 4.
It is located on or near 62. In one embodiment, the second intracardiac lead 450 is a coronary sinus vein.
) 464 via the great coronary vein 46
Introduced into six apical branches, the coronary vein 466
To a location within or into the branch vein of the coronary vein 466, thereby placing the distal pacing / sensing electrode 460 on or near the left ventricular epicardial surface 462.

In one embodiment, the distal pacing / sensing electrode 460 disposed on or near the left ventricular epicardial surface 462 and the housing 210 provide unipolar pacing and sensing of each ventricle of the heart. Used to provide. In another embodiment, distal pacing / sensing electrode 460 and first pacing / sensing electrode 42 provide bipolar pacing and sensing of each ventricle of the heart. In additional embodiments, a second distal pacing / sensing electrode is added to the outer periphery of the second intracardiac lead 450 to provide bipolar sensing and pacing of each ventricle of the heart.

In an additional embodiment, elongate body 452 further includes a plurality of tines 468 at or near distal end 458. The tines 468 are circumferentially spaced from one another and project radially away from the outer peripheral surface 454 toward the proximal end 456 of the elongated body 452. In one embodiment, the plurality of tines are comprised of the same material used to make elongated body 452 of second intracardiac lead 450.

The aspects of the invention set forth herein have application to implantable cardioverter defibrillators / defibrillators with multiple pacing modes, as known to those skilled in the art. As described. However, the intracardiac lead of the present invention may also be used in any number of implantable medical devices or external medical devices such as external defibrillator / monitor devices. Further, the intracardiac lead of the present invention may have additional or fewer defibrillation coil electrodes and / or pacing / sensing electrodes. For example, the intracardiac lead could have only the first defibrillation coil electrode 40 and the first pacing / sensing electrode 42, in which case cardiac sensing would be electrically connected to the first pacing / sensing electrode 42. This is done by unipolar detection between the defibrillator / defibrillator 22 and the housing 210. Further, between the first defibrillation coil electrode 40 and the housing 210 of the defibrillator / defibrillator 22, unipolar defibrillation electrical energy is supplied to the heart.

[Brief description of the drawings]

FIG. 1 is a schematic illustration of an implantable cardioverter defibrillator / defibrillator with one embodiment of an intracardiac lead implanted in the heart, with the intracardiac lead shown to show details. Line fragments were removed.

FIG. 2 is a schematic diagram of one embodiment of the intracardiac lead of the present invention.

FIG. 3 is a cross-sectional view of the embodiment of the intracardiac lead of FIG. 2, taken along line 3-3.

FIG. 4 is a schematic diagram of one embodiment of the intracardiac lead of the present invention.

FIG. 5 is a schematic illustration of an implantable cardioverter defibrillator / defibrillator with one embodiment of an intracardiac lead implanted in the heart, with the intracardiac lead shown to show details. Line fragments were removed.

6A-6C are partial enlarged views of one embodiment of the electrode housing on the intracardiac lead of the present invention.

FIG. 7 is a block diagram of an implantable cardioverter defibrillator / defibrillator of the present invention.

FIG. 8 is a schematic diagram of an embodiment of the intracardiac lead of the present invention.

FIG. 9 is a schematic diagram of an embodiment of the intracardiac lead of the present invention.

FIG. 10 is a schematic diagram of an embodiment of the intracardiac lead of the present invention.

FIG. 11 is a cross-sectional view of the embodiment of the intracardiac lead of FIG. 10 taken along line 11-11.

FIG. 12 is a schematic illustration of an implantable cardioverter defibrillator / defibrillator with one embodiment of an intracardiac lead implanted in the heart, with the intracardiac lead shown to show details. Line fragments were removed.

[Procedural Amendment] Submission of translation of Article 34 Amendment of the Patent Cooperation Treaty

[Submission date] May 15, 2000 (2000.5.15)

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Claims

[Correction method] Change

[Correction contents]

[Claims]

[Procedure amendment 2]

[Document name to be amended] Statement

[Correction target item name] 0004

[Correction method] Change

[Correction contents]

[0004] Implantable cardioverter / defibrillators (ICDs) have been successfully used to treat patients who have experienced at least one hemodynamically significant ventricular tachycardia or ventricular fibrillation. It has been. The basic ICD consists of a main battery, electronic circuitry that controls both the sensing of the patient's heart signal and the delivery of an electric shock to the patient's heart, and a high voltage housed in a sealed titanium case. And a capacitor row. One or more catheter leads having defibrillation electrodes are then implanted within the patient's heart or on the epicardial surface of the patient's heart. In addition, the catheter lead is connected to the implantable housing and electronics of the ICD and used to deliver defibrillation-level electrical energy to the heart. Examples of catheter leads include U.S. Patent Nos. 5,683,447, 5,534,022, 4,497,326 and European Patent Application 0812886.

[Procedure amendment 3]

[Document name to be amended] Statement

[Correction target item name] 0009

[Correction method] Change

[Correction contents]

SUMMARY OF THE INVENTION The present invention provides a single intracardiac lead that lowers the defibrillation threshold and improves arrhythmic recurrence after defibrillation shock treatment. One aspect of these improvements resides in placing each electrode on an intracardiac lead. The electrode shape on the intracardiac lead improves the potential gradient created by defibrillation level shocks,
This increases the effectiveness of cardiac defibrillation shock and lowers the defibrillation threshold as compared to conventional intracardiac leads. Also, the position of the pacing electrode relative to the defibrillation electrode provides a more reliable and accurate post-shock electrogram. Furthermore, because the defibrillation threshold is reduced, the battery consumption of the implantable device is reduced, and the life of the device can be extended as much as possible and / or the size of the device can be reduced overall. Become like

[Procedure amendment 4]

[Document name to be amended] Statement

[Correction target item name] 0018

[Correction method] Change

[Correction contents]

DETAILED DESCRIPTION In the following detailed description, reference is made to the accompanying drawings, which form a part hereof, and in which:
Reference will now be made to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. While these embodiments have been described in sufficient detail to enable those skilled in the art to make and use the invention, other embodiments may be utilized without departing from the scope of the invention. Obviously, electrical, logical and structural changes may be made. Therefore, the following detailed description should not be construed in a limiting sense, and the scope of the present invention is defined by the appended claims.

[Procedure amendment 5]

[Document name to be amended] Statement

[Correction target item name] Brief description of drawings

[Correction method] Change

[Correction contents]

[Brief description of the drawings]

FIG. 1 is a schematic illustration of an implantable cardioverter defibrillator / defibrillator with one embodiment of an intracardiac lead implanted in the heart, with the intracardiac lead shown to show details. Line fragments were removed.

FIG. 2 is a schematic diagram of one embodiment of the intracardiac lead of the present invention.

FIG. 3 is a cross-sectional view of the embodiment of the intracardiac lead of FIG. 2, taken along line 3-3.

FIG. 4 is a schematic diagram of one embodiment of the intracardiac lead of the present invention.

FIG. 5 is a schematic illustration of an implantable cardioverter defibrillator / defibrillator with one embodiment of an intracardiac lead implanted in the heart, with the intracardiac lead shown to show details. Line fragments were removed.

6A-6C are partial enlarged views of one embodiment of the electrode housing on the intracardiac lead of the present invention.

FIG. 7 is a block diagram of an implantable cardioverter defibrillator / defibrillator.

FIG. 8 is a schematic diagram of an embodiment of the intracardiac lead of the present invention.

FIG. 9 is a schematic diagram of an embodiment of the intracardiac lead of the present invention.

FIG. 10 is a schematic diagram of an embodiment of the intracardiac lead of the present invention.

FIG. 11 is a cross-sectional view of the embodiment of the intracardiac lead of FIG. 10 taken along line 11-11.

FIG. 12 is a schematic illustration of an implantable cardioverter defibrillator / defibrillator with one embodiment of an intracardiac lead implanted in the heart, with the intracardiac lead shown to show details. Line fragments were removed.

──────────────────────────────────────────────────の Continuation of front page (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE ), CA, JP (72) Inventor: Heil, Ronald W .; United States, Minnesota 55113, Roseville, Western Avenue North 2312 (72) Inventor Shiner, Abram United States of America, Minnesota 55127, Bud Nace Heights, Meadowwood Circle 4403 (72) Inventor Lin, Yayun United States of America, Minnesota 55113, Cent Paul, Freon Avenue 1866 (72) Inventor Bi, Lyre A. United States, Minnesota 55014, Reno Lakes, Vicky Lane 775 (72) Inventor Utuka, Jay. John United Kingdom, Sally Katy 13 Zero UEX, Weybridge, Cadon Way 44 F-term (reference) 4C053 CC02

Claims (20)

[Claims] 1. A lead body extending from a proximal end to a distal end, the proximal end having electrical connections to a pacing electrode and a defibrillation electrode, wherein the defibrillation electrode is a distal end of the lead body. Wherein the pacing electrode is disposed on the lead wire main body between the base end and the defibrillation electrode. 2. The lead according to claim 1, wherein said defibrillation electrode is arc-shaped. 3. The lead of claim 1, wherein said defibrillation electrode and said pacing electrode are located within 3 centimeters of each other. 4. The lead wire according to claim 1, wherein the defibrillation electrode has an arc shape. 5. The lead according to claim 1, further comprising a second defibrillation electrode disposed on the lead wire main body between the base end and the pacing electrode. line. 6. The lead of claim 5, wherein the pacing electrode and the second electrode are located within 8 centimeters of each other. 7. The lead of claim 5, wherein the pacing electrode and the second electrode are located within 15 centimeters of each other. 8. The lead according to claim 1, wherein the pacing electrode has a holding element. 9. The lead according to claim 8, wherein said retaining element comprises a helical screw. 10. The lead wire according to claim 1, wherein the lead wire body further has an outer sheath for the pacing electrode, and the pacing electrode can extend from inside the outer sheath. . 11. The lead body is defined by a first longitudinal axis, the pacing electrode is extendable along a second longitudinal axis, and the first longitudinal axis is defined by the second longitudinal axis. 11. The lead according to claim 10, wherein the lead is parallel to. 12. The distal end of the lead body defines a first longitudinal axis, the pacing electrode is extendable along a second longitudinal axis, and wherein the pacing electrode is extendable along a second longitudinal axis. 11. The lead according to claim 10, wherein the angle with respect to the longitudinal axis is less than 90 [deg.]. 13. The lead according to claim 1, wherein the lead body is J-shaped. 14. The lead of claim 13, wherein the pacing electrode is disposed on a first side of the lead body, and wherein the J-shape curves away from the first side of the lead body. . 15. The lead of claim 13, wherein the J-shape has a radius of curvature of about 1 to 3 centimeters. 16. The distal end is defined by a first longitudinal axis, the proximal end is defined by a second longitudinal axis, and the first longitudinal axis is at 45 ° to the second longitudinal axis. The lead wire according to any one of claims 1 to 12, wherein the lead wire is disposed at an angle of up to 60 °. 17. The pacing electrode according to claim 1, comprising a porous mesh.
16. The lead according to any one of 16 above. 18. The lead according to claim 1, wherein the pacing electrode has a hemispherical shape. 19. The lead according to claim 1, further comprising a second pacing electrode, wherein the second pacing electrode is disposed between the proximal end and the pacing electrode. One of the lead wires. 20. The lead wire according to claim 1, further comprising a plurality of tines disposed around the defibrillation electrode.