Abstract
An implantable electrode lead having proximal and distal ends, comprising an electrode lead body and a pulling element. The pulling element has first and second ends. At the first end, the pulling element is connected to the distal end of the electrode lead or in the vicinity of the electrode lead distal end; referred to as the distal region of the electrode lead. Proceeding from the joining site between the first end of the pulling element and the electrode lead, the pulling element extends from the first end thereof toward the second end thereof to the proximal end of the electrode lead. The pulling element, proceeding from the joining site, extends outside the electrode lead body. A tensile force exerted onto the second end of the pulling element exerts a bending moment onto the electrode lead distal region. This bending moment results in bending of the electrode lead distal region.
Claims
1. An implantable extravascular electrode lead, comprising: an electrode lead body extending from a distal end of the electrode lead to a proximal end of the electrode lead; an elongated pulling element having a first end and a second end, the pulling element, with the first end thereof, being connected to the electrode lead body by means of a joining site at the distal end of the electrode lead body of the electrode lead or in the distal region of the electrode lead, the pulling element, in the elongated state of the electrode lead, extending from the joining site to the proximal end of the electrode lead and, at least in the distal region of the electrode lead, extending outside the electrode lead body, and a tensile force exerted onto the second end of the pulling element exerting a bending moment onto the distal region of the electrode lead, which results in bending of the distal region of the electrode lead.
2. The implantable extravascular electrode lead according to claim 1, wherein a guide element, by which the pulling element is guided on the electrode lead body or in the electrode lead body, is arranged on the electrode lead body.
3. The implantable extravascular electrode lead according to claim 2, wherein the guide element is the designed in the form of a ring, an eyelet or a sleeve.
4. The implantable extravascular electrode lead according to claim 2, wherein the guide element is designed in the form of a channel inside the electrode lead body, which extends at least along a portion of the electrode lead body.
5. An implantable extravascular electrode lead according to claim 2, wherein the distance between the guide element and the joining site along the electrode lead body is between 30 mm and 800 mm.
6. An implantable extravascular electrode lead according to claim 1, wherein an electrode pole in the form of a shock coil is arranged on the electrode lead body between the joining site and the guide element.
7. An implantable extravascular electrode lead according to claim 1, wherein an engagement device is arranged on the electrode lead body close to the guide element or as part of the guide element, and a mating piece for the engagement device is arranged at the distal end of the electrode lead or at the joining site, the mating piece for the engagement device being designed to engage in the engagement device during insertion of the same so as to establish a mechanical connection between the mating piece for the engagement device and the engagement device.
8. The implantable extravascular electrode lead according to claim 7, wherein, in addition to a mechanical connection, also an electrical connection is established as a result of the connection between the engagement device and the mating piece for the engagement device.
9. An implantable extravascular electrode lead according to claim 2, wherein a plurality of guide elements are arranged spaced apart from one another on the electrode lead body in such a way that pulling on the pulling element causes the electrode lead body to contract in a meander-shaped manner.
10. An implantable extravascular electrode lead according to claim 1, wherein the pulling element is designed in the form of a thread, a cable, a wire, a bar or a rod.
11. An implantable extravascular electrode lead according to claim 1, wherein the pulling element is designed as a bar or a rod is precurved.
12. An implantable extravascular electrode lead according to claim 1, wherein the pulling element is resorbable.
13. An implantable extravascular electrode lead according to claim 1, wherein a plug is arranged on the electrode lead body at the proximal end of the electrode lead, and the plug is configured with a locking unit in such a way that the pulling element can be locked on the plug.
14. A system for inserting an implantable extravascular electrode lead, comprising an electrode lead according to claim 1 and a catheter having a lumen, wherein the electrode lead and the pulling element are arranged in the lumen of the catheter.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] Further features, advantages and embodiments of the present invention shall be described hereafter with reference to the figures.
[0031] In the drawings:
[0032] FIGS. 1A and 1B show an electrode lead comprising an externally guided pulling cable;
[0033] FIG. 2 shows an electrode lead comprising an engagement device;
[0034] FIG. 3A to 3E show an electrode lead comprising multiple guide elements, which can form a meander;
[0035] FIGS. 4A and 4B show an electrode lead comprising two separate distal regions;
[0036] FIGS. 5A and 5B show an electrode lead comprising an introducer sheath; and
[0037] FIG. 6 shows an introducer sheath having a special design distally.
DETAILED DESCRIPTION
[0038] FIG. 1A shows an electrode lead 1 having a proximal end 2 and a distal end 3, wherein a plug 40 for connecting the electrode lead to an active implantable device (not shown) is provided at the proximal end 2. An electrode pole in the form of a coil 30 is arranged in the distal region 5 of the illustrated electrode lead 1. In this case, the coil 30 is provided in the form of a shock coil or in the form of a large-area electrode pole serving as a base electrode or ground. The electrode lead 1 further comprises a pulling element 20, which is attached on the joining site 25 at the distal end 3 of the electrode lead 1. In this exemplary embodiment, the pulling element 20 is designed as a thread or cable. Proceeding from the distal end 3 of the electrode lead 1, the pulling element 20 is received by the guide element 60. In this embodiment, the guide element 60 is provided in the form of a channel inside the electrode lead body 10.
[0039] In FIG. 1B, a tensile force 21 is exerted onto the pulling element 20 of the electrode lead 1 in the direction of the arrow. The distal region 5 of the electrode lead 1 is bent into a loop 80 by this tensile force 21. The circular shape of the loop 80 is achieved by the guide element 60. Without the distal guide element 60, it would not be possible without further aids to bring the distal end 3 of the electrode lead 1 to the electrode lead body 10. Moreover, the guide element 60 makes it possible that the exact direction of the tensile force 21 exerted onto the pulling element 20 does not matter for the mechanism to function. Rather, only the portion of the pulling element 20 that is pulled out of the guide element 60 at the proximal end 2 of the electrode lead 1 as a result of the force application 21 must be increased.
[0040] FIG. 2 shows the section of the electrode lead body 10 of the electrode lead 1 on which the pulling element 20 enters the guide element 60. An engagement device 50, in which the mating piece for the engagement device 51 arranged at the distal end 3 of the electrode lead 1 can engage, is present at the entry site into the guide element 60. In this way, the distal end 3 of the electrode lead 1 is mechanically connected to the electrode lead body 10 after being brought close by the pulling element 20. Moreover, the engagement device 50 and the mating piece for the engagement device 51 can be designed in such a way that, in addition to the mechanical connection, also an electrical contact is established between the distal end 3 of the electrode lead and the engagement device 60. In this way, for example, the electrode coil 30 can be electrically connected in two points so as to reduce the voltage drop along the coil 30.
[0041] In particular with subcutaneous defibrillators, it is essential that the voltage causing the shock forms a stimulation vector that preferably runs through the heart of the patient. Since it is difficult to optimally place the housing electrode given the large volume of the housing, as an alternative another electrode lead can be used as a counter pole to the stimulation or shock electrode pole. As large an effective electrode surface as possible is advantageous for such electrode leads. The electrode lead 1 shown in FIG. 1B offers an option for increasing the effective electrode surface of an electrode lead 1 by the formation of a loop 80. Another option for increasing the effective electrode surface is implemented by the formation of a meander.
[0042] FIGS. 3A to 3E show electrode leads 1 by which a meander can be formed. For this purpose, the electrode lead 1 shown in FIG. 3A comprises multiple guide elements 60 arranged along the electrode lead body 10 thereof. The pulling element 20, which, in turn, is connected at the distal end 3 by the joining site 25 to the electrode lead 1, is inserted into the guide elements 60 so as to extend alternately on both sides of the electrode lead body 10. When a tensile force 21 is now exerted onto the pulling element 20, a meander-shaped region of the electrode lead 1 is formed, as shown in FIG. 3B. The meander-shaped portion of the electrode lead advantageously comprises a coil 30, serving as the electrode pole.
[0043] So as to stabilize the meanders shown in FIG. 3B, spacers 70 in the form of sleeves can additionally be threaded onto the pulling element 20 (see FIG. 3C). These sleeves 70 cause a specific, predefined distance to be maintained between the individual branches of the meander (see FIG. 3D) when a tensile force 21 is exerted onto the pulling element 20. If the spacers 70 are dispensed with, the individual branches of the meanders contract, as shown in FIG. 3E, when, proceeding from the situation shown in FIG. 3B, an additional tensile force 21 is exerted onto the pulling element.
[0044] Both final configurations (FIGS. 3D and 3E) are advantageous to use as counter poles for a subcutaneous defibrillator.
[0045] FIG. 4A shows an electrode lead 1 on which two electrode poles are arranged in the form of a coil 30 in the distal region 5. This principle is not limited to two parallel coiled electrode poles 30 in the distal region 5 of the electrode lead 1. The electrode lead 1 shown in FIG. 4A furthermore comprises two pulling elements 20, so that the two distal regions 5 (“fingers”) are curved individually—analogously to FIG. 1A/1B—to form a loop 80 when a tensile force 21 is exerted on the respective pulling element 20 (see FIG. 4B).
[0046] As is shown in FIG. 5A, as an alternative to the guide elements 60 arranged on the electrode lead body 10 of the electrode lead 1, it is also possible to use systems comprising an electrode lead 1 and an introducer sheath 100. In the system shown in FIG. 5A, the electrode lead 1 is inserted into an introducer sheath 100. At the distal end 103 of the introducer sheath 100, the pulling element 20 of the electrode lead 1 enters the inner lumen of the introducer sheath 100 simultaneously with the electrode lead 1. During the joint insertion of the sheath 100 together with the electrode lead 1 into the body, the electrode lead 1 can be pulled back into the sheath 100. So as to allow the introducer sheath 100 to move better, the sheath comprises a handle 110 at the proximal end 102 thereof. When the introducer sheath 100 is pulled back in relation to the electrode lead 1, as is shown in FIG. 5A, the distal section 5 of the electrode lead 1 likewise forms a loop 80, analogously to FIG. 1B, as soon as a tensile force 21 is exerted onto the pulling element 20.
[0047] FIG. 5B shows a system comprising an introducer sheath 100 and an electrode lead 1 by which the coiled electrode pole 30 can be brought into a U shape or an elongated loop 80. For this purpose, the introducer sheath 100 additionally comprises an inner catheter 120, which is arranged inside the lumen of the sheath 100. To provide better maneuverability of the two catheters 100 and 120 arranged inside one another, a handle 110 is provided on the introducer sheath 100, and a handle 130 is also provided on the inner catheter 120. As a result of the handles 110 and 130, it is possible to move the two catheters 100 and 120 relative to one another. The electrode lead 1, in turn, is arranged inside the lumen of the inner catheter 120. At the distal end 103 of the introducer sheath 100, the pulling element 20 of the electrode lead 1 enters the inner lumen of the introducer sheath 100 simultaneously with the inner catheter 120.
[0048] Proceeding from the configuration of the two catheters 100 and 120 with respect to one another shown in FIG. 5B, a U is created, and ultimately an elongated loop, when—as is shown in FIG. 1B—a tensile force 21 is exerted onto the pulling element 20. The length of the U or of the elongated loop 80 is dependent on the distance by which the catheters 100 and 120 were displaced relative to one another. The longer the distal end 123 of the inner catheter 120 which protrudes at the distal end 103 of the introducer sheath 100 is selected, the longer the U or the elongated loop will be.
[0049] FIG. 6 shows the distal end 123 of the catheter 120 together with the lumen 121 extending on the inside thereof. Moreover, this catheter comprises a guiding aid 140. The guiding aid is designed in the form of a half shell or trough. It supports the formation of a clean curve, and consequently a clean formation of a loop 80 or a clean U shape. Furthermore, the guiding aid 140 helps to maintain the formation of the curve in the desired plane.
[0050] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.
