Source: http://www.google.com/patents/US20030163184?dq=5,675,808
Timestamp: 2017-12-15 20:32:44
Document Index: 660462264

Matched Legal Cases: ['art.\n1', 'art.\n3', 'art.\n4', 'art.\n6', 'art.\n16', 'art 402', 'art 402', 'art 402']

Patent US20030163184 - Single pass lead system - Google Patents
A single-pass endocardial lead electrode adapted for implantation in, on or about the heart and for connection to a system for monitoring or stimulating cardiac activity includes a lead body which is adapted for implantation within a single chamber of the heart, or multiple chambers of the heart. The...http://www.google.com/patents/US20030163184?utm_source=gb-gplus-sharePatent US20030163184 - Single pass lead system
Publication number US20030163184 A1
Application number US 10/337,208
Also published as US6212434, US6505082
Publication number 10337208, 337208, US 2003/0163184 A1, US 2003/163184 A1, US 20030163184 A1, US 20030163184A1, US 2003163184 A1, US 2003163184A1, US-A1-20030163184, US-A1-2003163184, US2003/0163184A1, US2003/163184A1, US20030163184 A1, US20030163184A1, US2003163184 A1, US2003163184A1
Inventors Avram Scheiner, William Hsu, David Flynn, Qingsheng Zhu, John Heil, Heil Ronald, Curtis Lindstrom, Booker Robert, Yayun Lin, Peter Kelley, Jay Warren, Gerrard Carlson, Carol Werlein, Aaron Janke, Mary Cole, Jeffrey Bartig, Gary Goebel, Douglas Heitkamp, Randall Peterfeso
Referenced by (92), Classifications (6)
US 20030163184 A1
A single-pass endocardial lead electrode adapted for implantation in, on or about the heart and for connection to a system for monitoring or stimulating cardiac activity includes a lead body which is adapted for implantation within a single chamber of the heart, or multiple chambers of the heart. The lead includes a first distal end electrode which has a first electrical conducting surface. The lead body also has a second electrode which has a second electrical conducting surface. The first and second electrodes are either passively or actively attached to the wall of the heart. The lead body also includes a curved portion which facilitates the positioning of the second electrode. The main lead body alternatively includes a recess into which an atrial lead body and an active fixation element attached to one end can travel from a recessed position to a position for fixation to the wall of the heart. The lead is attached to a pulse generator for producing pulses to the multiple sites within the heart.
1. An endocardial heart lead system, comprising:
an elongated generally flexible tubular housing having a proximal end for connection to a device and distal end for placement, in a use position, through the right atrium to the right ventricle of a heart;
a pair of ventricular electrodes respectively at and adjacent the distal end of the lead for contact in the ventricle and receiving ventricular signals of the heart;
an SVC electrode positioned on the tubular housing at a position spaced from the distal end for placement in the superior vena cava when the lead system is in the heart;
an atrial electrode positioned on the tubular housing at a position spaced from the distal end and from the SVC electrode for placement in the atrium when the lead system is in the heart;
the tubular housing including conductors therein connected to the electrodes and for connection to a device at the proximal end; and
said tubular housing having a curved portion, taking the form of a lateral protrusion along said tubular housing, in region of the atrial electrode to mechanically bias the atrial electrode into contact with the wall of the atrium of the heart when the lead system is in the use position.
2. A lead adapted for implantation in, on or about the heart and for connection to a system for monitoring or stimulating cardiac activity, said lead comprising:
a lead body having a curved portion at a selected distance from the distal end of the lead body;
a second electrode attached to the lead body, the second electrode positioned a distance from the first electrode on the curved portion of the lead body to facilitate attachment of the second electrode to a second chamber of the heart.
3. A single pass dual chamber lead adapted for endocardial implantation in, on or about the heart and for connection to a system for monitoring or stimulating cardiac activity, said system comprising:
a first electrode having an active fixation portion, said main lead body having a first recess therein housing the first electrode, the first electrode capable of moving between a first recessed position within said first recess and a second extended position outside the first recess so that the active fixation portion of the distal electrode can attach to the wall of the heart; and
a second electrode associated with the main lead body, the first electrode housed within a first chamber of the heart and the second electrode housed within a second chamber in the heart, the second electrode having an active fixation portion, said main lead body having a second recess therein housing the second electrode, the second electrode capable of moving between a first recessed position within said second recess and a second extended position outside the second recess so that the active fixation portion of the proximal electrode can attach to the wall of the heart.
4. A single pass dual chamber lead adapted for endocardial implantation in, on or about the heart and for connection to a system for monitoring or stimulating cardiac activity, said system comprising:
a second lead body attached to the main lead body, the second lead body having an active fixation portion for attachment to the wall of the heart; and
a first electrode attached to the main lead body; and
a second electrode attached to the second lead body near the active fixation portion.
5. A lead adapted for endocardial implantation in, on or about the heart and for connection to a system for monitoring or stimulating cardiac activity, said system comprising:
a second electrode attached to the lead body a selected distance away from the first electrode, the portion of said lead body between the first electrode and second electrode having a curve therein to facilitate positioning of the first electrode and the second electrode within the heart.
6. A system for detecting arrhythmias of the heart and for delivering signals to the heart, said system comprising:
a supplemental lead body carrying a first electrode, said supplemental lead body capable of being moved between a first position substantially within the first recess, and a second position substantially outside the first recess; and
a second electrode attached to the lead body.
a first leg having at least one pacing electrode; and
a second leg having at least one pacing electrode, said first and second leg for positioning within a chamber of the heart;
wherein the first leg is positioned at a first site within a single chamber of the heart and the second leg is positioned at a second site within the single chamber of the heart.
a lead body having a curved end portion;
a second leg having at least one pacing electrode, said first and second leg for positioning within a chamber of the heart; and
the first pacing electrode and the second pacing electrode positioned at two positions on the curved end portion of the lead body, said curved end portion being positioned within a single chamber of the heart so that the first pacing electrode is located at a first position within the single chamber and the second pacing electrode is located at a second position with the single chamber of the heart.
a first leg associated with the main lead body, the first leg including a first electrode having an active fixation portion, the first electrode removably disposed within the first recess; and
where the first recess receives the first electrode therein.
10. An implantable electrode with a helical tip comprising:
a helix disposed on said electrode, which helix is aligned along a radial axis of the electrode at said distal end; and
said implantable electrode having at least one feature selected from the group consisting of:
a) said helix having a coating of an insulating material on 5-95% of its surface,
b) said helix having at least part of its surface beyond said distal end of said electrode and said distal end of said electrode having a porous conductive surface,
c) a conductive porous surface at said distal end of said electrode, and
d) a porous conductive surface at the distal end of the electrode having an insulating coating covering from 5-95% of the surface of said porous conductive surface.
11. A distal tip electrode adapted for implantation in, on or about the heart and for connection to a system for monitoring or stimulating cardiac activity, said electrode comprising:
a porous conductive element disposed at a distal end of the electrode tip;
a surface area at the distal end of the electrode tip;
a helix disposed within said electrode, said helix comprising a conductor disposed in helical shape, wherein said helix travels along a radial axis of the electrode through said surface area; and
a helix guiding mechanism for directing movement of the helix during travel.
12. An electrode adapted for implantation in, on or about the heart and for connection to a system for monitoring or stimulating cardiac activity, said electrode comprising:
a lead body having a first end and a second end;
an electrode disposed proximate the first end of the lead body;
connector terminal disposed at said second end of the lead body, said connector terminal for connecting with a pulse generating unit;
an electrode tip disposed proximate one end of the electrode;
a surface at the distal end of the electrode tip, said surface further comprising an electrical conducting surface wherein said surface is comprised of a porous conductive element;
a helix disposed within said electrode, said helix comprising a conductor disposed in a helical shape, wherein said helix travels along a radial axis of the electrode through said surface thereby placing said helix in extension and retraction; and
a helix guiding groove for directing movement of the helix during extension and retraction of said helix.
13. A lead adapted for implantation in, on or about the heart and for connection to a system for monitoring or stimulating cardiac activity, said lead comprising:
an first electrode attached to the lead body;
a second electrode attached to one side of the curved portion of the lead body;
said first electrode disposed at the distal end of the lead body for contact with a first chamber of the heart; and
said second electrode positioned a distance from the first electrode on the curved portion of the lead body to facilitate attachment of the second electrode to a second chamber of the heart, where the second electrode protrudes outwardly from the lead body.
14. An electrode adapted for endocardial implantation in, on or about the heart and for connection to a system for monitoring or stimulating cardiac activity, said electrode comprising:
an electrode end;
a first electrically conducting surface at the distal end of the electrode end; and
a lead body having a circumferential outer surface, said lead body attached to said electrode end, said lead body having second electrical conduction surface protruding from a portion of the circumference of said lead body.
15. A bifurcated lead adapted for implantation in, on or about a heart, the lead comprising:
a main lead adapted to carry signals to and from the heart, the main lead body extending from a proximal end to a distal end, the distal end of the main lead body having a first electrode leg and a second electrode leg;
the first electrode leg including a first electrode assembly comprising a bipolar electrode having a first electrode and a second electrode, the first electrode assembly being adapted to be disposed within a first chamber of the heart; and
the second electrode leg including a second electrode assembly, the second electrode assembly comprising a bipolar electrode having a third electrode and a fourth electrode, the second electrode assembly being adapted to be disposed within a second chamber of the heart.
16. A lead adapted for implantation in, on or about a heart, the lead comprising:
a main lead body adapted to carry signals to and from the heart, the main lead body extending from a proximal end to a distal end, the distal end of the main lead body having at least one leg;
the at least one leg having an active fixation portion; and
a movement assembly operatively coupled with the active fixation portion of the at least one leg, the movement assembly configured to extend and retract the active fixation portion, the movement assembly comprising:
a housing having an internally threaded portion; and
an externally threaded collar engaged with the internally threaded housing.
This application is a continuation of U.S. patent application Ser. No. 09/643,125, filed on Aug. 21, 2000, which is a division of U.S. patent application Ser. No. 09/120,824, filed on Jul. 22, 1998, now issued as U.S. Pat. No. 6,212,434, the specifications of which are incorporated herein by reference.
This patent application is related to U.S. patent application Ser. No. 10/288,155, filed on Nov. 5, 2002 entitled: HIGH IMPEDANCE ELECTRODE TIP; U.S. patent application Ser. No. 09/121,020, filed on Jul. 22, 1998, entitled SINGLE PASS DEFIBRILLATION/PACING LEAD WITH PASSIVELY ATTACHED ELECTRODE FOR PACING AND SENSING; U.S. patent application Ser. No. 09/129,348, filed on Aug. 5, 1998, now issued as U.S. Pat. No. 6,119,043; U.S. patent application Ser. No. 09/661,531, filed on Sep. 14, 2000, now issued as U.S. Pat. No. 6,345,204; U.S. Pat. No. 09/121,288, filed on Jul. 22, 1998, now issued as U.S. Pat. No. 6,501,994; U.S. patent application Ser. No. 09/121,005, filed on Jul. 22, 1998, now issued as U.S. Pat. No. 6,141,594; U.S. patent application Ser. No. 09/121,019, filed on Jul. 22, 1998, now issued as U.S. Pat. No. 6,085,119; U.S. patent application Ser. No. 09/121,006, filed on Jul. 22, 1998, now issued as U.S. Pat. No. 6,152,954; U.S. patent application Ser. No. 09/121,018, filed on Jul. 22, 1998, now issued as U.S. Pat. No. 6,321,122; and U.S. patent application Ser. No. 08/996,355, filed on Dec. 22, 1997, now issued as U.S. Pat. No. 5,885,221, each of which is assigned to a common assignee. The related applications are incorporated herein by reference in their entirety.
[0038]FIG. 1 is a schematic view of a single-pass lead with electrodes for pacing at multiple sites within a single chamber of the heart.
[0039]FIG. 2 is a schematic view of a single-pass lead with electrodes for pacing at multiple sites within a single chamber of the heart, positioned within the right ventricle of the heart.
[0040]FIG. 3 is a block diagram illustrating a system for delivering signals to the heart constructed in accordance with one embodiment of the present invention.
[0041]FIG. 4 is a first perspective view illustrating a single-pass lead constructed in accordance with one embodiment of the present invention.
[0042]FIG. 5 is a second perspective view illustrating a single-pass lead constructed in accordance with one embodiment of the present invention.
[0043]FIG. 6 is a cross-section view taken along 6-6 of FIG. 4 illustrating a single-pass lead constructed in accordance with another embodiment of the present invention.
[0044]FIG. 7 is a cross-section view illustrating a portion of a single-pass lead constructed in accordance with yet another embodiment of the present invention.
[0045]FIG. 8 is a cross-section view illustrating a portion of a single-pass lead constructed in accordance with one embodiment of the present invention.
[0046]FIG. 9 is a cross-section view illustrating a portion of a single-pass lead constructed in accordance with one embodiment of the present invention.
[0047]FIG. 10 is a cross-section view illustrating a portion of a single-pass lead constructed in accordance with one embodiment of the present invention.
[0048]FIG. 11 is a perspective view illustrating a single-pass lead constructed in accordance with one embodiment of the present invention.
[0049]FIG. 12 is a perspective view illustrating a single-pass lead constructed in accordance with one embodiment of the present invention.
[0050]FIG. 13 is a perspective view illustrating a single-pass lead constructed in accordance with another embodiment of the present invention.
[0051]FIG. 14 is a side view of the single-pass endocardial lead for sensing and electrically stimulating the heart, positioned within the right ventricle and right atrium of the heart, constructed in accordance with one embodiment of the present invention.
[0052]FIG. 15A is a side view of a single-pass lead for sensing and electrically stimulating the heart constructed in accordance with one embodiment of the present invention.
[0053]FIG. 15B is a side view of a single-pass lead for sensing and electrically stimulating the heart constructed in accordance with one embodiment of the present invention.
[0054]FIG. 16 is a side view of a single-pass endocardial lead for sensing and electrically stimulating the heart constructed in accordance with one embodiment of the present invention.
[0055]FIG. 17A is a side view of a single-pass endocardial lead for sensing and electrically stimulating the heart constructed in accordance with one embodiment of the present invention.
[0056]FIG. 17B is a side view of stylet for use with the endocardial lead.
[0057]FIG. 18 is a perspective view of the atrial electrode portion of the lead showing a passive attachment element for attachment to the atrial wall of the heart.
[0058]FIG. 19 is a perspective view of another embodiment of the electrode for passive attachment to the atrial wall of the heart.
[0059]FIG. 20 is a perspective view of another embodiment of the electrode for passive attachment to the atrial wall of the heart.
[0060]FIG. 21 is a perspective view of another embodiment of the electrode for passive attachment to the atrial wall of the heart.
[0061]FIG. 22 is a perspective view of another embodiment of the electrode for passive attachment to the atrial wall of the heart.
[0062]FIG. 23 is a perspective view of another embodiment of the electrode for passive attachment to the atrial wall of the heart.
[0063]FIG. 24 is a perspective view of another embodiment of the electrode for passive attachment to the atrial wall of the heart.
[0064]FIG. 25 is a side view of a portion of a lead body showing an electrode for passive attachment to the atrial wall of the heart.
[0065]FIG. 26 is a side view of a single-pass endocardial lead for electrically stimulating the heart constructed in accordance with another embodiment of the present invention.
[0066]FIG. 27 is a side view of a single-pass endocardial lead implanted within the heart constructed in accordance with another embodiment of the present invention.
[0067]FIG. 28 is a side view of a single-pass endocardial lead for multi-site pacing during insertion with a first atrial leg straight and one atrial leg withdrawn into the lead body constructed in accordance with one embodiment of the present invention.
[0068]FIG. 29 is a side view of a single-pass endocardial lead for multi-site pacing during insertion with a first atrial leg formed into atrial ‘J’ after withdrawal of stylet and one atrial leg withdrawn into the lead body constructed in accordance with one embodiment of the present invention.
[0069]FIG. 30 is a side view of a single-pass endocardial lead for multi-site pacing during insertion with both atrial legs formed into a ‘J’ constructed in accordance with one embodiment of the present invention.
[0070]FIG. 31 is a side view of a single-pass endocardial lead for multi-site pacing during insertion with one atrial leg formed into a ‘J’ and one leg straight constructed in accordance with one embodiment of the present invention.
[0071]FIG. 32 is a side view of a single-pass endocardial lead for multi-site pacing during insertion with two atrial legs formed into a ‘J’ and one leg straight constructed in accordance with one embodiment of the present invention.
[0072]FIG. 33 is a side view of a single-pass endocardial lead for multi-site pacing constructed in accordance with one embodiment of the present invention.
[0073]FIG. 34 is a side view of a single-pass endocardial lead for multi-site pacing constructed in accordance with one embodiment of the present invention.
[0074]FIG. 35 is a side view of a single-pass endocardial lead for multi-site pacing constructed in accordance with one embodiment of the present invention.
[0075]FIG. 36 is a side elevational view illustrating a single-pass lead constructed in accordance with another embodiment of the present invention.
[0076]FIG. 37 is a cross-section view illustrating a single-pass lead constructed in accordance with one embodiment of the present invention.
[0077]FIG. 38 is a cross-section view illustrating a single-pass lead constructed in accordance with one embodiment of the present invention.
[0078]FIG. 39 is a cross-section view illustrating a single-pass lead constructed in accordance with one embodiment of the present invention.
[0079]FIG. 40 is a perspective view illustrating a movement assembly of the lead constructed in accordance with one embodiment of the present invention.
[0080]FIG. 41 is a first side elevational view illustrating a lead constructed in accordance with one embodiment of the present invention.
[0081]FIG. 42A is a cross-sectional view of an electrode tip of a lead for monitoring and stimulating the heart constructed in accordance with one embodiment of the present invention.
[0082]FIG. 42B is an end view of the electrode tip of the lead shown in FIG. 42A.
[0083]FIG. 43A is a cross-sectional view of an electrode tip of a lead for monitoring and stimulating the heart constructed in accordance with one embodiment of the present invention.
[0084]FIG. 43B is an end view of the electrode tip of the lead shown in FIG. 43A.
[0085]FIG. 44A is a cross-sectional view of an electrode tip of a lead for monitoring and stimulating the heart constructed in accordance with one embodiment of the present invention
[0086]FIG. 44B is an end view of the electrode tip of the lead shown in FIG. 44A.
[0087]FIG. 45A is a cross-sectional view of an electrode tip of a lead for monitoring and stimulating the heart constructed in accordance with one embodiment of the present invention
[0088]FIG. 45B is an end view of the electrode tip of the lead shown in FIG. 45A.
[0089]FIG. 46 shows a partially insulated helical tip constructed in accordance with one embodiment of the present invention.
[0091]FIG. 1 illustrates a schematic view of a system 100 for delivering electrical pulses or signals to stimulate and/or pace the heart. The system for delivering pulses 100 includes a pulse generator 102 and a lead 110, where the lead 110 includes a connector end or connector terminal 120 and extends to a distal end 130. The distal end 130 of the lead 110 includes at least two electrodes 132 and 134, which comprise either unipolar or bipolar type electrodes. For bipolar type electrodes, the electrode 132 would be part of a bipolar set including two electrodes. Similarly, the electrode 134, if bipolar, would be part of a set. The lead 110 includes a lead body 112 which, in one embodiment, is comprised of a tubing material formed of a biocompatible polymer suitable for implementation within the human body. Preferably, the tubing is made from a silicon rubber type polymer. The lead body 110 includes at least one lumen (not shown) which carries each electrical conductor from the connector terminal 120 to the electrodes 132 and 134. The electrical conductors carry current and pulses between the pulse generator 102 and the electrodes 132 and 134 located in the distal end 130 of the lead 110.
[0097]FIG. 2 is a schematic of a single-pass endocardial lead for electrically stimulating multiple sites within a single chamber of the heart which is positioned within the right ventricle of the heart, where the lead 110 is shown as having a distal end 130. The distal end 130 features includes a first electrode 132 and a second electrode 134. In FIG. 2, the distal end 130 of the lead body 110 passes through the right atrium and is positioned within the right ventricle 160 of the heart. Again, as before, the electrodes 132 and 134 may be unipolar or may be bipolar. In the instance when each of the electrodes 132 and 134 are bipolar, there is an additional electrode associated with each of the electrodes 132 and 134. Alternatively, in another embodiment, one of the electrodes 132 is unipolar and one of the electrodes 134 is bipolar.
[0099]FIG. 3 illustrates another embodiment of the present invention, showing a lead 170 adapted for delivering electrical pulses to stimulate the heart. The lead 170 has a lead body 172 extending from a proximal end 174, which is adapted to connect with equipment which supplies electrical pulses, to a distal end 176 which is adapted to be inserted into the heart. The lead body 172 includes an intermediate portion 178 which includes quad-lumen tubing as will be further discussed below. Proximate to the distal end 176 is a first electrode tip 180 including a first electrode assembly 182. A second electrode tip 184 is also provided, as discussed below, which includes a second electrode assembly 186.
[0103]FIG. 4 illustrates the lead of FIG. 3 in greater detail. The lead 200 extends from a proximal end 202 to a distal end 204 and includes a first and second connector terminal 280, 282 near the proximal end 202. The lead 200 also includes a lead body 220, a first electrode assembly 210, and a second electrode assembly 212, as will be further described below. The connector terminals 280, 282 electrically connect the various electrodes and conductors with the lead body to a pulse sensor and generator 190 (FIG. 3). The pulse sensor and generator 190 (FIG. 3) contain electronics to sense various pulses of the heart and also produce pulsing signals for delivery to the heart. The pulse sensor and generator 190 also contain electronics and software necessary to detect certain types of arrhythmias and to correct for them. Physicians are able to program the pulse sensor and generator to correct a particular arrhythmia that the patient may have. Numerous types of connector terminals which connect to a pulse sensing and generating unit can be used. In one embodiment, the connector terminals 280, 282 are designed to conform with International Standards.
[0111]FIG. 11 illustrates another embodiment showing a lead 300. The lead 300 extends from a proximal end 302 to a distal end 304 and comprises a first and second connector terminal 380, 382 near the proximal end 302. The lead 300 also includes a lead body 320, a first electrode assembly 310, and a second electrode assembly 312. Near the proximal end 302 of the lead body 320, the lead body 320 has at least two IS1 terminal legs, including a first terminal leg 330 and a second terminal leg 332.
The second electrode leg 354, in one embodiment, has a J-shape, which can have either passive or active fixation, as will be further discussed below. Using a straight stylet (not shown) to straighten the electrode leg 354 prior to implant, the second electrode leg 354 is positioned within the right atrium of the heart. As the stylet (not shown) is removed, the second electrode leg 354 re-assumes the J-shape and becomes positioned within the atrium of the heart. If a passive configuration is used, as further discussed below (for example, FIG. 36), the distal end 355 of the second electrode leg 354 becomes embedded within the wall of the heart as tissue in-growth begins. If an active fixation configuration is used, the distal end 355 of the second electrode leg 354 is positioned adjacent the wall of the heart. The fixation helix is advanced so that it screws into the wall of the heart and the second electrode leg 312 is engaged. The discussions of leads for multi-site pacing and/or passive and active fixation devices in related U.S. Pat. Nos. 6,141,594 and 6,085,119 are hereby incorporated by reference in their entirety.
[0115]FIG. 13 shows another embodiment of the invention. In this configuration, the atrial lead 390 and/or the ventricle lead 396 each have an active fixation element 394, as further described below, for fixating the leads 390, 396 to the endocardial wall of a heart. The active fixation element 394 is rotatable by terminal pins 398, and the active fixation element 394 is not retractable. Alternatively, the active fixation element 394 can be rotated using other manners, for example, a stylet. To protect the patient during implantation or to prevent snagging of the fixation element 394, the active fixation element 394 of the atrial lead 390 and/or the ventricle lead 396 is covered with a dissolvable coating 397, such as mannitol. The dissolvable coating 397 remains intact during insertion of the leads 390, 396 through the subclavian vein and into the heart. The dissolvable coating 397 prevents the active fixation element 394 from catching tissue in the vein during insertion. Once implanted, the coating 397 dissolves to expose active fixation element 394 and allow it to be turned into the atrial wall of the heart. The dissolvable coating 397 is depicted by a dotted line enclosure around the active fixation element 394.
[0118]FIG. 14 also shows the lead terminal connector 410 and its connection into the pulse generator 440. The lead terminal connector 410 makes electrical connection with a signal processing/therapy circuit 442 which in turn is electrically connected to a microcontroller 444. Within the microcontroller 444 is a synchronizer 446. The signal processing/therapy circuit 442 determines the type of therapy that should be delivered to the heart 402. The microcontroller 444 controls the delivery of the therapy to the heart 402 through the synchronizer 446. The synchronizer 446 times the delivery of the appropriate signal to the heart 402.
[0119]FIG. 15A shows the lead 400 in greater detail. The lead 400 includes a connector terminal 410, a distal end 430, and an intermediate portion 420 which interconnects the distal end 430 and the connector terminal 410, and include conductive wires (not shown) covered by a silicone rubber tubing which is biocompatible, to form the lead body 422. The connector terminal 410 electrically connects the various electrodes and conductors within the lead body 422 to the pulse generator 440 (discussed above). The distal end 430 is the portion of the lead 400 that includes electrodes and is positioned within the heart during implantation. The lead body 422 is a tubing material formed from a biocompatible polymer for implantation, and preferably tubing made from a silicone rubber polymer. The silicone rubber polymer tubing contains several electrical conductors (not shown). The electrical conductors are made of a highly conductive, highly corrosion resistant material.
[0123]FIG. 15B shows an alternative embodiment, which includes a fifth electrode 463 on the lead 400. The electrode 463 is positioned on the lead 400 adjacent the electrode 461 so that there are two sensing electrodes, 461 and 463 in the atrium of the heart to enhance the sensing capability of this lead. In one embodiment, the electrode 461 comprises a porous tip electrode, as will be further described below.
[0124]FIG. 16 shows a lead 500 used to treat a bradycardia condition. The reference numerals associated with the lead 400 shown in FIGS. 14 and 15 which describe similar parts have been used here for the purposes of simplicity. The lead 500 includes a distal or RV pace sense tip 454, an atrial sense electrode 461, and a ring electrode 510. The distal end 430 of the lead 500 includes a straight portion 460 and a curved portion 450. The atrial sense electrode 461 is positioned on the curved portion 450. The atrial sense electrode 461 can also be provided with a means for passive fixation to the wall of the heart. In this unipolar application, the distal tip electrode 454 serves as the negative pole and the pulse sensor and generator 440 serves as the positive pole when a pacing pulse is delivered to the right ventricle of the heart. It should be noted that this is not the only possible unipolar arrangement, but that other unipolar arrangements are possible. Furthermore, it should be noted that a bipolar arrangement may also be used.
[0127]FIG. 17A illustrates an alternative form of a lead 520. A conventional endocardial lead, having standard electrodes for the RV tip 522, RV coil 524, and SVC coil 526 on a generally flexible multi-lumen tubular body 530 is shown. Also included is an additional SVC sense ring 528, and a curved shape 532 to hold the sense ring into contact with the interior wall of the atrium or superior vena cava. The lead 520 includes a curved portion 532 which in one embodiment, comprises a semi-flexible, semi-rigid arch which is set in the lead to form a lateral protrusion. The curved portion 532 mechanically biases the atrial sense ring into contact with the inside wall of the atrium, or can be used to bias the lead 520 into contact with other parts of the heart wall. In one embodiment, the curved portion 532 is spaced from the distal tip 534 of the lead 520 so as to be placed in the atrium when the lead 520 is in its use position with the RV tip 522 is in the ventricle. In one embodiment, the atrial sense ring 528 is a small ring electrode paced around the lead at the curved portion 532, in a position where it will be in contact with the atrium when the lead is placed in the heart. In another embodiment, the axis of the sense ring 528 is aligned with the axis of the lead body 530. In yet another embodiment, the axis of the sense ring 528 is co-axial with the axis of the lead body 530. The advantage of the above embodiments is that the atrial sense ring 528 is held in direct contact with the atrial wall, which provides better signals for P wave discrimination, as compared with lead designs which do not ensure such direct contact.
The lead may be constructed generally according to known techniques for multi-lumen intravascular electrode leads, an example of which is shown and described in U.S. Pat. No. 4,603,705 to Speicher et al. The addition of atrial sense ring 528 will require an additional conductor inside the body of the lead. For this reason, the lead of FIG. 17A has four lumens 536, which are seen in the section 550 drawn at the top of the FIG. 17A. The four lumens 536 are the atrial ring lumen, the distal RV coil lumen, the proximal SVC coil lumen, and the lumen for the stylet coil 540 (FIG. 17B) which may also serve as the conductor for the tip electrode. A stylet coil 540, as illustrated in FIG. 17B, is normally found in multi-lumen intravascular electrode leads, consisting of a flexible metallic coil in one of the lumens serving to receive a stylet as is generally known for facilitating directional control of the lead during its placement in the heart. The double-bend portion or curved portion 542 of the stylet coil 540 which forms the curved portion 532 may preferably be formed by forming the bends in the stylet coil to take a ‘set’ in which the curved portion 532 is shaped as shown in FIG. 17A. The stylet coil 540 has sufficient flexibility to straighten, then return towards the set shape after removal of the stylet.
[0131]FIG. 19 shows another passive fixation electrode. FIG. 19 shows a conductive ring 560 made of a highly corrosion-resistant material such as an alloy of platinum and iridium, and in one embodiment is electrically insulated from body fluids. The ring includes two small porous tip electrodes 556 and 558, which are electrically active and in contact with body fluids. The active porous tip electrodes 556 and 558 each include a screen of porous conductive material made of the highly corrosion-resistant alloy of platinum and iridium. Tissue encapsulation grows into the screen on the tips 556 and 558 to attach the electrode to the endocardial wall of the heart.
[0132]FIG. 20 shows another passive fixation element associated with the curved portion of the lead. A conductive ring 562 made of a highly corrosion-resistant material such as an alloy of platinum and iridium, and in one embodiment is electrically insulated from body fluids. The ring 562 includes a porous tip electrode 564, which is electrically active and in contact with body fluids. The porous tip 564 in FIG. 20 is larger than the porous tip 554 shown in FIG. 18, where the porous tip 564 extends across a substantial amount of the tip 564. In one embodiment, the porous tip 564 is made of corrosion-resistant material and comprises a screen. When the porous tip 564 rests against the endocardial wall of the heart, the tissue of the heart encapsulates and grows into the screen to passively attach the electrode to the heart.
[0133]FIG. 21 illustrates a variation of the electrode shown in FIG. 20, where the conductive ring 570 includes a first porous tip 572 and a second porous tip 574. The ring 570 is electrically insulated from body fluids, and the first and second porous tips 572 and 574 are electrically active and in contact with body fluids. The porous tips 572, 574 are also made of highly corrosion-resistant material. Like the previous conductive rings shown, the tissue of the heart encapsulates and grows into the porous screen in order to provide passive attachment of the electrode to the endocardial wall of the heart.
[0134]FIG. 22 shows that a smooth ring 578 can also be used as the main element of the electrode in the curved portion of the lead. The smooth ring 578 is made of a corrosion-resistant material that is highly conductive. All of the ring 578 can be exposed or a portion of it can be masked or insulated, so that a portion is nonconductive.
[0135]FIG. 23 shows another variation and includes a ring 580. A surface 582 of the ring 580 is comprised of layers of conductive mesh or other porous materials attached to the ring 580. The layers of conductive mesh or porous materials create an active surface for pacing and sensing and a layer for enhanced tissue ingrowth. Alternatively, texturization or other surface treatment could be applied directly to the ring 580 to enhance tissue ingrowth.
[0136]FIG. 24 illustrates another embodiment of an electrode for use with the curved portion of the lead. A ring 584, made of highly conductive material insulated from body fluids includes a modified raised ridge 586. In one embodiment, layers of conductive porous material are deposited on an electrically conductive thin band 587 rather than across the entire width of the ring. In another embodiment, all of the ring 584 can be exposed or a portion of it can be masked or insulated so that a portion is nonconductive.
[0137]FIG. 25 shows an portion of a lead 590 including a porous tip type of electrode 594 (similar to the porous tip shown in FIGS. 18 and 19) which is not mounted on a ring. The porous tip electrode 594 is placed in either a straight or curved portion of the lead. In one embodiment, the porous tip electrode 594 is placed directly into the surface of the lead 590, and an electrical conductor 596 is attached to the electrode. In another embodiment, the surface of the lead 590 near the electrode 594 may be textured to enhance the ability of the lead 590 to become passively fixed to the wall of the heart. It should be noted that the above described electrodes illustrated in FIGS. 18-25 can be used along any curved or straight portion of a lead, and can be disposed in the various positions described above. The pacing and sensing tip points out in the direction of the bias or, alternatively, is on the portion of the lead body that is closest to the wall of the heart.
[0138]FIG. 26 is a side view of one type of lead 600 for delivering electrical pulses to stimulate the heart. The lead 600 is comprised of a connector terminal 610 and a lead body 620. The lead 600 attaches to a pulse sensor and generator 640. The lead body has a number of electrodes in the distal end 630 which is implanted within, on, or about the heart (FIG. 27). The distal end 130 of the lead body 120 includes a curved or bias portion 150 and a straight portion 160. The connector terminal 610 electrically connects the various electrodes and conductors within the lead body to the pulse sensor and generator 640. The pulse sensor and generator 640 contains electronics to sense various pulses of the heart and also produce pulsing signals for delivery to the heart. The pulse sensor and generator 640 also contains electronics and software necessary to detect certain types of arrhythmias and to correct for them. Physicians are able to program the pulse sensor and generator to correct a particular arrhythmia that the patient may have. It should be noted that there are numerous types of connector terminals which connect to a pulse sensing and generating unit 640. The lead terminal connector 610 provides for the electrical connection between the electrodes on the lead 100 and pulse generator 640. The connector terminal end 610 shown is designed to international IS-1 Standard ISO 5841-3(E).
The discussions of leads having a curved portion in related U.S. patent application Ser. No. 09/121,020, filed on Jul. 22, 1998 entitled SINGLE PASS DEFIBRILLATION/PACING LEAD WITH PASSIVELY ATTACHED ELECTRODE FOR PACING AND SENSING, and related U.S. Pat. Nos. 6,152,954, 6,321,122 and 5,885,221, all of which are hereby incorporated by reference in their entirety. The above described leads, including but not limited to multi-site pacing leads for one or more chambers of the heart, as well as bifurcated leads can also be combined with the embodiments relating to the leads having a curved portion.
[0144]FIG. 28 illustrates a side view of a single-pass endocardial lead 700 for multi-site pacing within a single chamber of the heart. During insertion, a stylet or wire is placed down a lumen within the lead 700. This makes for a stiffened lead body 700 which can be pushed through the body into the appropriate chamber of the heart. The lead 700 includes a connector end 720 which, in one embodiment, has a yoke 710 and extends to a distal end 730. The lead 700 also includes a first leg 740 and a second leg 750, which each include at least one electrode.
[0146]FIG. 29 illustrates another side view of the lead 700 after the stylet (not shown) which extends down the body of the lead 700 and into the first leg 740 has been removed. When the stylet is removed, the first leg 740 is allowed to return to its natural state. In this particular case, the first leg 740 of the lead 700 includes a curve therein, for example, a J-shaped curve. The radius of the curve and the length of the leg 740 are or may be varied in order to accomplish placement of the lead 732 at various positions within a particular single chamber of the heart. It should be noted that FIG. 29 illustrates the second leg 750 still housed within the recess 712 in the body of the lead 700.
[0148]FIG. 31 shows a variation of a single-pass endocardial lead 760 for multi-site pacing from the ones shown in FIGS. 28-30. The lead 760 shown in FIG. 31 includes many of the same elements of the lead shown in FIGS. 28, 29, and 30. Rather than repeat all the same elements or similar elements between the lead 760 and the lead 700 shown in FIGS. 28, 29, and 30, only the differences will be touched upon or described in the following paragraph.
[0150]FIG. 32 shows yet another embodiment of a single-pass endocardial lead 770 for multi-site pacing within a single chamber of the heart. The lead 770 includes a connector end 774 and a distal end 776 having a first leg 778, a second leg 780 and a third leg 782. The lead 700 has a recess which is capable of holding a second leg 780, and a third leg 760. The first leg 778 is, in one embodiment, J-shaped or, alternatively, curved and includes an electrode 784. The electrode 784, in another embodiment, is used as part of an active fix element 786. The first leg 778 also includes a set of tines 788 which enables or allows active fixation of the electrode 778 to an endocardial wall of the heart. The second leg 780 is a straight leg having an electrode 792 and an active fix portion 794. The third leg 782 includes an electrode 796 and an active fix portion 798.
[0152]FIGS. 33, 34, and 35 show several other embodiments of the invention. FIG. 33 is a side view of a lead 800 which includes an active fixation element 832 for attachment to the atrial wall of the heart. The lead 800 includes a main lead body 802, an atrial lead body 805 (FIGS. 34 and 35) and a ventricle lead body 804. The main lead body 802 is attached to a yoke 806. The yoke 806 acts as a strain reliever and also has a series of terminal pins 808, 810 and 812 attached to the yoke/strain reliever 806. The terminal pins 808, 810, and 812 are attached to the pulse generator (not shown). The main lead body 802 is longer than as shown; a break has been put into the main lead body 802 to illustrate that the main lead body 802 is longer than that shown in FIG. 33.
[0154]FIG. 34 is a side view of the embodiment of a lead 800 shown in FIG. 33. FIG. 34 has a J-shaped atrial lead body 807 which emerges from the recess 814 in the main body 802 of the lead 820. On the end of the atrial lead 807 is an active fixation element 832. The active fixation element 832, in one embodiment, includes a helically shaped hook for screwing into the atrium of the heart. The J-shape of the lead facilitates positioning of the end of the electrode having the active fixation element 832 to a desired position within the atrium. The J-shape eases positioning within the atrium of the heart when certain portions of the atrium are the target for connection of the active fixation element 832. Once properly positioned, a surgeon can turn and/or advance the active fixation element 832 causing it to hook the tissue in the inner wall of the heart. The atrial lead 807, in one embodiment, is moved with respect to the recess 814 by pushing the respective terminal pin 810 toward the yoke 806. By moving the terminal pin 810 toward the yoke 806, a conductor, which connects the terminal pin 810 and the active fixation element 832, moves with respect to the main body 802 of the lead 820. Alternatively, the terminal pin 810 can be moved longitudinally with respect to the main body 802. This movement causes the atrial lead body 807 to emerge or pass through or pass out of the recess 814 in the main body 802. The terminal pin 810 and the active fixation element 832 attached to it, in one embodiment, move independently of the lead body 820. Twisting the terminal pin causes the active fixation element 832 on the atrial lead body 807 to turn and affix itself to the atrial wall of the heart. This additional degree of freedom allows for movement of the lead body relative to the fixed atrial electrode without unscrewing (or over-screwing) the electrode from the endocaridal tissue. A locking mechanism may be provided to prevent the active fixation element 832 from “backing out” after it has been affixed to the wall. The atrial lead 807, in another embodiment, is prestressed so that it will take the J-shape upon leaving or coming out of the recess 814.
[0155]FIG. 35 is a side view of another embodiment of the lead shown in FIG. 33. In this particular embodiment, the lead 830 has a straight atrial lead body 840 which comes out of the recess 814 in the main lead body 802. The position of the atrial lead body 840 is controlled by movement of the terminal pin 810 with respect to the yoke 806. Moving the terminal pin 810 with respect to the yoke 806 causes the atrial lead 840 to come out of the recess 814. An active fixation element 832 is positioned on the end of the atrial lead 840. Once the surgeon positions the atrial lead 840 and the active fixation element 832 at the end of the atrial lead 840 in a proper position or desired position, the active fixation element 832 is used to attach the proximal electrode to the endocardial wall of the atrium.
[0158]FIG. 38 shows the electrode 861 extended from the lead body 860. The electrode 161 and active fixation screw 863 move independent of the lead body 860. This relative movement allows the electrode to come in contact with the wall without manipulation of the lead body 860. The electrode 861 can then be fixed by rotating the electrode 861 and attached fixation screw 863. The fixation screw 863 of the electrode 861 can be advanced and retracted independent of rotation of the lead body 860. The active fixation screw and attached electrode, in one embodiment, are controlled from the terminal end, as discussed above.
In yet another embodiment, the lead, as described above and below, has an increased impedance or a high impedance which can act to extend the life of the battery. The discussion of leads having a curved portion in related U.S. Pat. No. 6,501,994 is hereby incorporated by reference in its entirety. It should be noted that, in an alternative embodiment, the below discussed high impedance embodiments can also be combined with the above described lead embodiments including, but not limited to multi-site pacing for one or more chambers of the heart, bifurcated leads, and leads having curved portions. There are a number of ways in which increased impedance may be effected for mechanically fastened electrode connections in atrial/ventricular implantable catheters (AVIC) systems. These include at least the following: 1) a fully insulated tissue engaging tip (at least with respect to all surfaces that are in electrical contact or electrically active physical relationship to heart muscles so that a pace would be effective if discharged at that portion of the tip), 2) a partially insulated (only a portion of the surface area of the engaging tip being insulated, preferably there is sufficient coating so that at there is at least 5%, or at least 10%, or at least 20 or 30%, or at least 40, 50 or 60%, or at least 70, 75, 80 or 90% of the surface area of the tip which can discharge to heart muscle [or as percentages of the entire tip or as percentages of the entire tip that extends physically beyond the end plane of the catheter and which may therefore penetrate tissue or muscle]), 3) a porous, electrically conductive element, such as a mesh or screen of material at the proximal end of the helix or the distal end of the lead (excluding the helix), at the base of an extended engaging tip, 4) the selection of materials in the composition of the mesh and/or tip which provide higher impedance, 5) the partial insulative coating of a porous conductive element, such as the mesh or screen to increase its impedance, and 6) combinations of any of these features. There may be various constructions to effect the increased or high impedance, including the use of helical tips with smaller surface areas (e.g., somewhat shorter or thinner tips). There may also be other elements associated with the catheter and/or leads, such as a sheath of material inert to body materials and fluids, circuitry, microcatheters, and at least one conductor extending through the lead body.
In yet another embodiment, a partially insulated fixation helix is used to provide a relatively high impedance electrode design. Leads comprising a distal or electrode end and a proximal or connector end may be used. A “miniature” wire-in-basket porous electrode may be sintered upon the distal end of a metallic pin, provided with a blind hole. Circumferential to this subassembly, a sharpened wire fixation helix may be positioned and attached at a general location proximal to the electrode by any convenient means which allows electrical continuity. This attachment includes, but is not limited to, crimping, spot welding, laser welding, the use of grooves upon the surface of the pin, the use of thin metallic overband (also not shown) or any combination thereof. A portion of this fixation helix is provided with an extremely thin layer of a biostable, biocompatible polymer, which, inter alia, provides electrical insulation between the fixation helix and the cardiac tissue. In one embodiment, the insulated portion is the majority of the fixation helix, leaving a relatively small uninsulated region of fixation helix. This approach offers increased impedance to reduce energy dissipation in pulsing functions, such as pacing functions. Other varying embodiments include, but are not limited to, a portion which is approximately or substantially equal to half of the fixation helix, and a portion which is approximately or substantially equal to a minority of the fixation helix. Such embodiments provide different amounts of uninsulated region and different amounts of impedance. The thin coating of electrically insulating coating must usually be at least 1 micron in thickness to provide a significant insulating effect, depending upon its insulating ability and properties. The thickness of the coating is limited primarily by physical limitations on the system. The coating can not be so thick as to interfere with the fastening ability of the helix or to in crease the size of the helix beyond that which is tolerable for the use of the helix and the patient. Typically, the coating is at least one micron up to about 100 microns, more typically the coating is between 1 and 30 microns, preferably between 1.5 and 20 microns, more preferably between 1.5 and 15 microns, and most preferably between 2 and 10 microns. The material used for the coating should, of course, be biocompatible and even more preferably non-thrombogenic. Materials such as Parylene TM, polyurethanes, polyacrylates (including polymethacrylates), polyesters, polyamides, polyethers, polysiloxanes, polyepoxide resins and the like can be used. Crosslinked polymers within these classes may be preferred for their resistance to breakdown and their physical durability. As the coating is to be maintained within the body of a recipient, the coating composition should not be water-soluble or aqueous soluble within the parameters and environment encountered within animal bodies (e.g., it should not be soluble within blood, serum or other body fluids with which it might come into contact).
To the proximal end of this pin, a metallic conductor coil may be conveniently attached to provide electrical connection to the implantable pacemaker (not shown) by means of a connector. In one embodiment, local (e.g., steroid or other medicinal) therapy is provided by a (e.g., circumferential) steroid/polymer matrix positioned immediately proximal to the porous electrode. In one embodiment, the circumferential steroid/polymer matrix is provided with a distal taper. Other embodiments include other distal configurations, including, but not limited to, non-tapered or “inflated” configurations. In one embodiment, an internalized, medicinal or biologically active (e.g., steroid) releasing matrix is used. Proximal to this biologically active (e.g., steroid) eluting matrix, a generally cylindrical polymeric tubing (this is the preferred shape, but the shape is a matter of choice) 1820 is used to provide electrical insulation of this entire assembly. In one embodiment the lead is “unipolar.” In one embodiment an ablative protective covering positioned over the entirety of distal end 520 is used (not shown). One example of such a covering is the mannitol “Sweet Tip”TM electrode of Cardiac Pacemaker, Inc. CPI/Guidant. In one embodiment, a “bipolar” lead is provided with the distal electrode features described.
[0214]FIG. 46 shows a high impedance catheter tip 1800 with a partially insulated tip 1802 and a partially insulated mesh 1808. The partially insulated tip (or helix) 1802 comprises one fully insulated section 1804 and one uninsulated section 1806. The partially insulated mesh 1808 comprises a first area 1810 of the mesh 1808 which is insulated and second are 1812 of the mesh 1808 which is not insulated. The impedance of the catheter tip can be readily controlled by the amount of surface area of the helical tip itself and the area of the mesh (if present) which is insulated. With a fixed conductivity in the tip and the mesh (if present), the impedance can be increased by increasing the percentage of the surface area of the tip or mesh which is insulated.
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