Implantable lead for septal placement of electrode with fixation mechanism in the pulmonary artery

Abstract

A lead body includes an electrode coupled to an intermediate portion of the lead body. A distal end of the lead includes a pre-formed, biased shape adapted to passively fixate the distal end of the lead within a pulmonary artery with the electrode positioned in the right ventricle or ventricular outflow tract. The lead body can include a pre-formed J-shape, with the electrode coupled to the intermediate portion of the lead body and located distally from a bottom of the pre-formed J-shape. The lead body can include a section of the intermediate portion of the lead body being less stiff than adjacent sections of the lead body with the electrode coupled to the intermediate portion of the lead body and located distally from the less stiff section.

1 . A lead comprising: 
 a lead body extending from a proximal end to a distal end and having an intermediate portion; and    an electrode coupled to the intermediate portion of the lead;    wherein the distal end of the lead includes a pre-formed, biased shape adapted to passively fixate the pre-formed biased shape of the distal end of the lead within a pulmonary artery with the electrode positioned in the right ventricle or ventricular outflow tract; and    wherein the intermediate portion of the lead includes a lead configuration structure which configures the lead such that the electrode is moved towards a ventricular septum when the distal end of the lead is within the pulmonary artery and the electrode is positioned in the right ventricle or ventricular outflow tract.    
   
   
       2 . The lead of  claim 1 , wherein the pre-formed, biased shape includes an S-shaped configuration.  
   
   
       3 . The lead of  claim 1 , wherein the pre-formed, biased shape includes a C-shaped configuration.  
   
   
       4 . The lead of  claim 1 , wherein the pre-formed, biased shape includes a spiral configuration.  
   
   
       5 . The lead of  claim 1 , wherein the pre-formed, biased shape includes a J-shaped curve at a distal tip of the lead body.  
   
   
       6 . The lead of  claim 1 , wherein the pre-formed, biased shape includes at least two surfaces positioned to contact opposing walls of the pulmonary artery.  
   
   
       7 . The lead of  claim 1 , wherein the pre-formed, biased shape includes at least one curve in the lead body dimensioned such that at least two lead surfaces on the distal end of the lead contact at least two walls of the pulmonary artery.  
   
   
       8 . The lead of  claim 1 , wherein the lead configuration structure includes a pre-formed J-shape, wherein the electrode is located distally from a bottom of the pre-formed J-shape.  
   
   
       9 . The lead of  claim 1 , wherein the lead configuration structure includes a section of the intermediate portion of the lead body which is less stiff than adjacent sections of the lead body, the less stiff section located proximally from the electrode.  
   
   
       10 . The lead of  claim 1 , wherein electrode includes a defibrillation coil electrode.  
   
   
       11 . The lead of  claim 1 , further comprising a pacing/sensing electrode located distally from the electrode to sense or pace within the ventricular septum or the ventricular outflow tract.  
   
   
       12 . The lead of  claim 1 , wherein at least a portion of the lead includes an anti-thrombosis coating.  
   
   
       13 . The lead of  claim 1 , further comprising a sensor mounted to the distal end to monitor cardiac output through the pulmonary artery.  
   
   
       14 . A lead comprising: 
 a lead body extending from a proximal end to a distal end and having an intermediate portion;    an electrode coupled to the intermediate portion of the lead;    means for passively fixating the distal end of the lead within a pulmonary artery, wherein the distal end of the lead includes a pre-formed shape section to passively fixate the pre-formed shape section within the pulmonary artery; and    wherein the intermediate portion of the lead includes a lead configuration structure which configures the lead such that the electrode is moved towards a ventricular septum when the distal end of the lead is within the pulmonary artery and the electrode is positioned in the right ventricle or ventricular outflow tract.    
   
   
       15 . The lead of  claim 14 , wherein means for passively fixating include the distal end of the lead having an S-shaped configuration.  
   
   
       16 . The lead of  claim 14 , wherein means for passively fixating include the distal end of the lead having a C-shaped configuration.  
   
   
       17 . The lead of  claim 14 , wherein means for passively fixating include the distal end of the lead having a spiral configuration.  
   
   
       18 . The lead of  claim 14 , wherein means for passively fixating include the distal end of the lead having a J-shaped curve at a distal tip of the lead body.  
   
   
       19 . The lead of  claim 14 , wherein means for passively fixating include the distal end of the lead having at least two surfaces positioned to contact opposing walls of the pulmonary artery.  
   
   
       20 . The lead of  claim 14 , wherein means for passively fixating include the distal end of the lead having at least one curve in the lead body dimensioned such that at least two lead surfaces on the distal end of the lead contact at least two walls of the pulmonary artery.  
   
   
       21 . A lead comprising: 
 a lead body extending from a proximal end to a distal end and having an intermediate portion, wherein the lead body is configured into a pre-formed J-shape; and    an electrode coupled to the intermediate portion of the lead body and located distally from a bottom of the pre-formed J-shape, wherein the lead is adapted to be placed within a heart in a J-shaped configuration with the bottom of the J-shape within the right ventricle and the electrode positioned proximate a ventricular septum or a right ventricular outflow tract such that at least a portion of the distal end of the lead body is located within a pulmonary artery, wherein the distal end of the lead includes a pre-formed, biased shape adapted to fixate the distal end of the lead within the pulmonary artery when the pre-formed biased shape is within the pulmonary artery.    
   
   
       22 . The lead of  claim 21 , wherein the distal end of the lead is adapted to be passively fixated within the pulmonary artery.  
   
   
       23 . The lead of  claim 21 , wherein the distal end of the lead is adapted to be actively fixated within the pulmonary artery.  
   
   
       24 . The lead of  claim 21 , further comprising a second electrode located proximally from the bottom of the J-shape and positioned to be located within a superior vena cava or right atrium when the distal end of the lead is within the pulmonary artery.  
   
   
       25 . The lead of  claim 21 , further comprising a pacing/sensing electrode located distally from the electrode to sense or pace within the ventricular septum or the ventricular outflow tract.  
   
   
       26 . The lead of  claim 21 , wherein at least a portion of the lead includes an anti-thrombosis coating.  
   
   
       27 . The lead of  claim 21 , further comprising a sensor mounted proximate the distal end of the lead body to monitor cardiac output through the pulmonary artery.  
   
   
       28 . A lead comprising: 
 a lead body extending from a proximal end to a distal end and having an intermediate section, the distal end being adapted for being fixated within a pulmonary artery; and    an electrode mounted to the intermediate section of the lead body;    wherein the lead body includes a pre-formed J-shape with a base of the J-shaped lead body being proximally located relative to the electrode such that the electrode contacts a ventricular septum when the lead is positioned in a heart with the intermediate section within the right ventricle and the distal end fixated within the pulmonary artery, wherein the distal end of the lead includes a pre-formed, biased shape adapted to passively fixate the distal end of the lead within the pulmonary artery when the pre-formed biased shape is within the pulmonary artery.    
   
   
       29 . The lead of  claim 28 , wherein the distal end of the lead includes an S-shaped configuration.  
   
   
       30 . The lead of  claim 28 , wherein the electrode includes a defibrillation coil electrode.  
   
   
       31 . The lead of  claim 28 , further comprising a pacing/sensing electrode located distally from the electrode to sense or pace within the ventricular septum or the ventricular outflow tract.  
   
   
       32 . A lead comprising: 
 a lead body extending from a proximal end to a distal end and having an intermediate portion, wherein a section of the intermediate portion of the lead body is less stiff than adjacent sections of the lead body; and    an electrode coupled to the intermediate portion of the lead body and located distally from the less stiff section, wherein the lead is adapted to be placed within a heart in a J-shaped configuration with the less stiff section near a bottom of the J-shape such that the electrode is positioned proximate a ventricular septum or a right ventricular outflow tract and at least a portion of the distal end of the lead body is located within a pulmonary artery.    
   
   
       33 . The lead of  claim 32 , wherein the less stiff section includes a different material than the adjacent sections.  
   
   
       34 . The lead of  claim 32 , wherein the less stiff section has a smaller diameter than the adjacent sections.  
   
   
       35 . The lead of  claim 32 , wherein the distal end of the lead is adapted to be passively fixated within the pulmonary artery.  
   
   
       36 . The lead of  claim 32 , wherein the distal end of the lead is adapted to be actively fixated within the pulmonary artery.  
   
   
       37 . The lead of  claim 32 , further comprising a second electrode located proximally from the less stiff section such that the second electrode is within the superior vena cava or right atrium when the distal end of the lead is within the pulmonary artery.  
   
   
       38 . The lead of  claim 32 , further comprising a pacing/sensing electrode located distally from the electrode to sense or pace within the ventricular septum or the ventricular outflow tract.  
   
   
       39 . The lead of  claim 32 , wherein at least a portion of the lead includes an anti-thrombosis coating.  
   
   
       40 . The lead of  claim 32 , further comprising a sensor mounted proximate the distal end of the lead body to monitor cardiac output through the pulmonary artery.  
   
   
       41 . A lead comprising: 
 a lead body extending from a proximal end to a distal end and having an intermediate section, the distal end being adapted for being fixated within a pulmonary artery; and    an electrode mounted to the intermediate section of the lead body;    wherein the intermediate section of the lead body includes a less stiff section relative to adjacent sections of the lead body, the less stiff section being proximally located relative to the electrode, such that the electrode contacts a ventricular septum when the lead is positioned in a heart with the intermediate section within the right ventricle and the distal end fixated within the pulmonary artery.    
   
   
       42 . The lead of  claim 41 , wherein the distal end of the lead includes a biased pre-formed shape adapted for passively fixating the distal end within a pulmonary artery.  
   
   
       43 . The lead of  claim 41 , wherein the electrode includes a defibrillation coil electrode.  
   
   
       44 . The lead of  claim 41 , further comprising a pacing/sensing electrode located distally from the electrode to sense or pace within the ventricular septum or the ventricular outflow tract.  
   
   
       45 . The lead of  claim 41 , wherein the less stiff section includes a different material than the adjacent sections.  
   
   
       46 . The lead of  claim 41 , wherein the less stiff section has a smaller diameter than the adjacent sections.