Electrode cable for attachement to a vessel wall

0001The invention relates to a vascular electrode lead for a pacemaker.

0002In the treatment of various chronic arrhythmias have long been implanted pacemaker in conjunction with intracardiac on a arranged electrode catheter and positioned at the inner heart wall Stimulation electrodes in use, on the energized the excitable heart tissue and by a defect in the body's cardiac impulse-forming and -leitungssystems is balanced.

0003The design of the electrode lines has been continuously improved. With the aim of a long-term guarantee good contact between the or the stimulation electrode (s) and the heart tissue in the interests of both energy-saving and safe stimulation are numerous technical solutions for Anchoring the electrode leads to the heart wall - both in the ventricle been found and actually - (ventricle) and in the atrium (Atrium) substantial practical improvements succeeded.

0004There are also electrode lines - especially for implantable defibrillators - been proposed, which are inserted into large heart near vessels and Add defibrillation to the vessel wall.

0005EP 0601338 A1 describes such an electrode system for an implanted Defibrillator, at least two - without special anchoring alone because of their size held stationary - intravascular placed coil electrodes (Spiral electrodes) comprises. One of these large paddles may be specially arranged in the superior vena cava, a further in the coronary sinus.

0006The US 5,571,159 describes a temporarily usable catheter for atrial Defibrillation, the positioned adjacent a first, in the atrium spiral Electrode portion a second, placed in the pulmonary artery electrode portion and at the distal end of an inflatable balloon for positioning the having electrodes.

0007EP 0566652 B2 describes a shaped in the manner of a stent and by means of a Dilation balloon expandable electrode configuration for use as a defibrillating in a blood vessel, especially in coronary sinus.

0008For certain applications - such as the so-called bi-atrial or multisite Stimulation - can also be a placement of pacemaker stimulation or Sensing electrodes in a close to the heart vessel, especially in the coronary sinus, appropriate be because an electrode implantation is especially in the left atrium problematic. For this purpose, the known large-area defibrillation electrodes are in principle not.

0009The invention is therefore based on the object, one for the pacemaker stimulation or sensing of cardiac activity suitable vessel electrode line of the aforementioned type specify.

0010This object is achieved by a vessel electrode line with the characteristics of Claim 1.

0011The invention includes the idea of ​​a vessel electrode line with at least one small-area electrode and adapted to the vessel configuration to realize fixatives, with in an efficient manner and with exact

0012transmitted positioning pacing pulses to the vessel wall or Cardiac action potentials can be tapped.

0013To implement this idea, the proposed electrode line comprises an electrode or electrodes, the effective diameter (as of intracardiac Elektrdoenanordnungen known) is approximately equal to the diameter of The body is not acting as an electrode (in particular an insulating Surface having) fixing means for fixed positioning of the electrode or electrodes with respect to the vessel wall.

0014The fixation means of the proposed vessel electrode line differ of which to be anchored intracardiac electrode lines in the figure, but at least the dimensions, as they are not a fixing by anchoring used in relatively thick muscle tissue or the trabecular meshwork of the ventricle. Rather, the fixing based against either an elastic strain the vessel wall or alternatively the engagement in the wall or branches an addition vessel.

0015According to the first alternative, the fixing means comprise an in substantially coplanar with sinusoidal or on the lateral surface of a cylinder elliptical base helically elastically pre-cut portion of the Body. This has (in the relaxed state) preferably a lateral Extension from two to five times the Durchmesssers the base body and is matched to the elasticity of the vessel wall Elastitizät. He has one Longitudinal extent that in the interest of safe positioning avoidance high local stress on the vessel wall expediently more than one Sine period or more than a full cylinder jacket-circulation includes.

0016In the execution of the second alternative are at the distal end of the body flexible fixing means for fixing the said side tube (especially the Coronary sinus) with matched to the diameter of the lateral extension attached, and the body is highly flexible in this area carried out to allow easy bending in the side vessel into it.

0017As such a fixing agent is preferably a distal end of the body surrounding plastic worm thread section with one or more Turns, in particular from the material of the base body, is provided with which the electrode line in a smaller venous side of the coronary vessel can be actively fixed. This is the "screwing" of the electrode line Although largely closed, to the resultant congestion is at a but Page vessel tolerable.

0018As an alternative to the latter embodiment, the base body, a plurality of compared to its longitudinal axis towards the proximal end resiliently inclined carry plastic fins, with which the vessel electrode line in branches the near the heart vasculature can be passively anchored. The dimensions of the Finns or "fins" are larger in coordination with the other bodies around than in similar arrangements anchored in the trabecular meshwork of the ventricle will.

0019Further provide for the introduction of stretchable elastic filament or an expandable stent in the form of a tube or after the introduction of annular suitable hollow body adapted to the final dimensions of vessel diameter Fixative represents.

0020Here, it is advantageous if the electrically active surface is relatively small. Do this by either at least partially isolating the surface or at least partial execution of a non-conductive material or by minimum dimensions of the entire fixing element can be achieved. The electrodes may be placed on the line that (unipolar at a Line) or the electrode (at a bi- or multipolar line) the most distal of a plurality of electrodes a distance between 30 and 80 mm from the distal end of the The basic body has, so that in conjunction with a tuned on this distance Curvature of the base body in the implanted state, a stable Orientation of the electrode (s) is ensured relative to the vessel wall. correspondingly is in a bipolar lead, the distance of the electrodes between 30 and 80 mm. The use of a tip electrode is - alone or in combination with a ring electrode - possible.

0021The first and / or second stimulation electrode preferably has a geometric Surface area in the range between 10 and about 25 mm² and in particular a fractal Surface microstructure to enlarge the electrically active surface by a factor of at least 10² on.

0022Also preferred is a waxing positively influencing drug coating provided, such as a collagen or fibronectin coating.

0023Particularly advantageous embodiments result from the realization that in the Practice for fixing the line most appropriate place not in solid Positional relationship to the appropriate location for the stimulation of the best Vessel is. This leads to the consideration, the electrically active part of the An order requesting the measures provided for mechanical fixing part in to make certain limits freely positionable. This is expediently by the provision of separate support for the electrodes on the one hand and the one or more to realize attachment means on the other hand, that of during placement Electrode line are movable relative to each and their position according to Determining the optimal position for the fixation means and the electrodes is set.

0024Setting, for example, by crimping or by a collet similar Means at plugs happen.

0025Advantageous further developments of the invention are, moreover, in the dependent claims be in or below together with the description of the preferred embodiment of the invention based on the figures in more detail. It show:<ul><li>Figures 1, 1a, 1b are schematic illustrations of a vessel electrode line according to a first embodiment of the invention in Side view and front views of the distal end in two modifications,</li><li>Figure 2 is a schematic representation of a vessel electrode line according to a second embodiment in side view,</li><li>Figure 3 is a schematic representation of a vessel electrode line according to a third embodiment,</li><li>Figure 4 is a schematic representation of a vessel electrode line according to a fourth embodiment,</li><li>Figures 5, 5a is a schematic representation of a vessel electrode line according to a fifth embodiment,</li><li>Figures 6, 6a is a schematic representation of a vessel electrode line according to a sixth embodiment,</li><li>Figure 7 is a schematic representation of a vessel electrode line according to a seventh embodiment and</li><li>Figures 8a to 8d are schematic illustrations of different embodiments of a detail in the vessel of the electrode lines in Fig. 5 to 7 type shown.</li></ul>

0026Fig. 1, 1a and 1b show a vessel 10 having an electrode line (not shown) electrode leads receiving body 11, a plug 12 and two ring electrodes 13, 14. The front (more distal) ring electrode 13 has a Distance of about 25 mm from the distal end of the line, to which a X-ray marker portion PtIr 15 is provided, a diameter of 2 mm, and a length of 2 mm. The rear (proximal of) electrode 14 of the front electrode has a distance between 60 and 80 mm, a diameter of 2.4 mm and a Length of 3 mm.

0027The distal portion 11a of the base body 1 1 has made a means of soul tempered steel MP35N elastically pre-embossed, approximately sinusoidal or S-shaped Curvature and at the same time an elliptical coiling, which in Figure 1a or 1b it can be seen (in two variants of the course). The maximum lateral extent the electrode line is in this area in coordination with the diameter of the predetermined area of ​​use provided vessel and is for a coronary sinus electrode line about 8 mm. The elasticity of the line by appropriate Choice of strength and material handling conditions of the steel core in such a way predetermined to by used in the implantation guidewire can be stretched easily and after removal of the guide wire in configuring a sufficient for position fixing pressure shown the vascular wall exert, without this significantly expand.

0028Fig. 2 shows another vessel line electrode 20 with a main body 21, a plug 22 and a tip electrode 23 and a ring electrode 24, the a distance of about 30 mm from each other. Again, the distal Area 21a of the conduit 20, which extends over a length of about 60 mm, a sinusoidal curve and coiling impressed that close to the tip electrode a gentle curve shows and only near the position of the ring electrode assumes higher gradient. The curved portion here comprises approximately two Sine periods and rounds on the mantle of the coiling of descriptive elliptical cylinder.

0029A stretched in the distal end portion of the vessel electrode line 30 with a The base body 31 and a plug 32 is shown in Fig. 3. The line 30 comprises two ring electrodes 33 and 34 having diameters of 2 mm or 2.4 and Lengths of 2 or 3 mm. The nearer to the distal end of the line Electrode 43 has at the end a distance of 75 mm, and the distance between two electrodes is 25 mm.

0030At the distal end is connected to the base body 31 is a made of a silicone polymer Screw spiral formed 35 added of about 5 mm length with two turns, which increases the overall diameter of the pipe in this area to approximately 3 mm. The conduit is guided during the implantation, that the "thread" at the top enters the mouth of a vessel side, and then they will be there by means of corresponding rotation of the guide wire screwed. by virtue of the pronounced bending elasticity of the line clamped to the end after fixing an arc of the vessel mouth of the side vessel from the opposite wall of the main vessel (such as the coronary sinus), so that the Electrodes communicate with the wall in contact without too much of a local Pressure is exerted on the vessel wall.

0031Another vessel electrode lead 40 from the plug 42 to the distal end continuously stretched course of the chassis 41 is shown in Fig. 4. The Line 30 comprises two ring electrodes 43 and 44 having diameters of 2 or 2.4 mm and a length of 3 mm each. The closer to the distal end of the line preferred electrode 43 has to end at a distance of 50 to 60 mm, and the Distance between two electrodes is from 30 to 40 mm.

0032At the distal end are at the base plastic fins or -Widerhaken 45 (Which is preferably made of the material of the base body, that is, a normally are silicone polymers formed) formed. The fins 45 are pronounced acute and longer than similar anchoring elements of intracardiac Electrode lines, but carried pliable. The line is by means of Guidewire guided so that the Finns themselves or in a vessel bifurcation caught the mouth of a vessel side and so the electrodes appropriately Position relative to the wall of the vessel intended for the attachment, especially the coronary sinus, fix.

0033FIGS. 5a and 5a show schematically a further vessel electrode line 50.

0034Regarding the arrangement of the base body 51 of the plug 52 and the Electrodes 53, 54 like this the arrangements of Fig. 3 or 4, so that insofar as the description is not repeated. However, here is the basic body 51 carried out so that he in axialverschieblicher way one against the Body by a few centimeters longer fixing member support body 56 receives. At its distal end is a highly elastic filament 55 from biocompatible metal (such as a NiTi alloy) or plastic attached. Also the carrier body 56 is hollow so that a guide wire 58 is inserted into it, to its proximal end a two-piece handle 57 is attached.

0035The guide wire 58 engages in a correspondingly formed end of the elastic Helix 55, so that these opposite by advancing the guidewire 58 the fixing element carrier body 56 can be stretched, as in the Illustration of the detail A of Fig. 5 can be seen in Figure 5a.

0036This allows easy insertion of the line 50 with a stretched filament 55. will achieve the desired placement location during withdrawal of Guidewire relieves Wendel and assumes its pre-stamped form in which it such a matched to the Innenabmwessungen the vessel Durchmesserhat, that it abuts against the wall under light pressure.

0037By axial displacement of the base body 51 on the thus fixed fixing member support body 56 by means of the second part of the handle 57 can then the optimum positioning of the electrodes 53, 54 in a relatively large adjustment to be made. After positioning is Finally (on, described below manner) the position of Body fixed relative to the fixing member support body and over the pin 52 if necessary. still projecting proximal end of the support body 56 separated, so that the implantation of the lead ends 50th

0038FIGS. 6 and 6a, a structure and function of the line described above of FIG. 5 similar vessel electrode line 60, but in which, instead of a resilient helical expandable one after the introduction in the manner of a stent tubular fixing element 65 is provided from a Ti alloy. Of the Handle 67 is used here only for moving the fixing member support body 66 relative to the base 61. It additionally has a luer lock connector 67a for connecting to a (not shown) fluid source for expanding the Fixing element 65 required by balloon dilatation in a conventional manner becomes. The expanded state showing the view of detail A in FIG. 6a.

0039Fig. 7 shows the embodiment of FIG. 3 similar vessel electrode line 70, but in which - as in the arrangements of Figures 5 and 6 -. for the screw-like Einschraubwendel 75 a recorded in-line main body 71 and this opposite axially displaceable support body 76 is provided, at its proximal end a handle 77 for displacing the carrier body 76 and the Screwing the screw flight 76 is mounted.

0040Fig. 8a to 8d show in schematic diagrams of different embodiments of an essential Details in vascular electrode lines of the kind shown in Figs. 5 to 7, namely the means for determining the position of the fixing means carrier body relative to Body. In Fig. 8a is for this purpose in the plug 52 'on the a Fixative carrier body 56 engaging set screw 52a provided in Fig. 8b, the inner pin 52.1 "of a modified connector 52" of two in the manner of a collet cooperating parts 52.1a "and 52.1b" formed, As best seen in the cross-sectional view of the detail A from FIG. 8b in Fig. 8c can be seen.

0041In the embodiment of Fig. 8d finally the fixing member support body 52 '' distal to the plug 52 '' with a - branched electrode leads to known per se - branch element 59 '' is provided, in which the fixing means carrier body 56 '' (and with this, the guide wire 58) laterally into the base body 51 '' is threaded. The setting after positioning is done here by means of a ligature.

0042The invention is not limited in its embodiment to the above specified preferred embodiments. Rather, a number of Variants are possible which gearteter of the solution presented in different make exemplary use.

0043Thus, the embodiments shown in FIGS. 1 and 2 can be modified to be that the distal end no coiling, but a substantially coplanar or spanned in two mutually orthogonal planes sinusoidal or having meandering preforming. Even the shape of a screw tip or can of barbs in the kind remarks by 3 or 4 -. in compliance the specifics of the application sites be varied in numerous ways - s.