Method and apparatus for fixating a pacing lead of an implantable medical device

Abstract

A method and apparatus for dynamically fixating and removing a lead in a vasculature of a body. At least one segmenting means such as a collar is disposed at a distal end of the lead forming a deployable actuable segment adapted to dynamically assume an engaging and retracted position. In an engaging position, the actuable segment dynamically and varyingly adapts into a shape or shapes to engage a vessel. In a retracted position the shape or shapes collapse thus maintaining the original geometry of the lead in the vasculature. The actuable segment assumes a deployed or retracted position based on the flexural condition of the segment, respectively.

What is claimed:  
     
         1 . An apparatus for fixating a lead disposed within a vessel, comprising: 
 a segment at a distal end of the lead;    at least one deployable lobe situated at the segment, the deployable lobe adapted to assume a retracted position and an engaging position, the engaging position engaging the at least one deployable lobe with the vessel; and    wherein the at least one deployable lobe assumes the engaging position in response to the segment being compressed and assumes the retracted position when the fixation segment is not compressed.    
     
     
         2 . The apparatus of  claim 1 , wherein the at least one deployable lobe is formed between a pair of elongated, substantially parallel slits in the segment.  
     
     
         3 . The apparatus of  claim 1 , wherein the compression of the segment causes the deployable lobe to extend outwardly from an outer surface of the segment.  
     
     
         4 . The apparatus of  claim 1 , wherein by not compressing the segment causes the deployable lobe to retract and become substantially parallel to an outer surface of the fixation segment.  
     
     
         5 . The apparatus of  claim 3 , wherein compression of the segment causes the deployable lobe to extend outwardly from the outer surface of the fixation segment and form an angular shape having an apex.  
     
     
         6 . The apparatus of  claim 5 , wherein the apex of the angular shape formed by the deployable lobe engages the vessel, thereby substantially fixating the lead within the vessel.  
     
     
         7 . The apparatus of  claim 1 , further comprising: 
 push tubing surrounding the lead and secured to the segment at one end thereof; and    an anchor member for securing an opposite end of the segment to the lead; and    wherein pushing of the push tubing toward the segment causes compression of the segment against the anchor member.    
     
     
         8 . An apparatus for fixating a lead disposed within a vessel, comprising: 
 at least one deployable lobe situated on a distal portion of the lead, the deployable lobe adapted to assume a retracted position and an engaging position, the engaging position engaging the at least one deployable lobe with the vessel;    a flexible material covering a portion of an outer surface of the lead; and    wherein the at least one deployable lobe assumes the engaging position by deforming of the flexible material a segment from the lead at the portion of the outer surface and assumes the retracted position by rectifying said deforming of the segment.    
     
     
         9 . The apparatus of  claim 8 , wherein the at least one deployable lobe comprises an expandable spring within the lead, and wherein the spring stretches the flexible material outwardly from the lead when the spring assumes the engaging position.  
     
     
         10 . The apparatus of  claim 9 , wherein the expandable spring is expanded to stretch the flexible material by rotating a conductor that is disposed within the lead.  
     
     
         11 . The apparatus of  claim 9 , wherein the expandable spring and flexible material engage the vessel when assuming the engaging position, thereby substantially fixating the lead within the vessel.  
     
     
         12 . The apparatus of  claim 8 , wherein the flexible material comprises at least one of polyisoprene, polyurethane, and silicone.  
     
     
         13 . The apparatus of  claim 8 , wherein the at least one deployable lobe comprises a stent within the lead, and wherein the stent stretches the flexible material outwardly from the lead when the stent assumes the engaging position.  
     
     
         14 . The apparatus of  claim 13 , wherein the stent and flexible material engage the vessel when assuming the engaging position, thereby substantially fixating the lead within the vessel.  
     
     
         15 . The apparatus of  claim 13 , wherein the stent is expanded to stretch the flexible material by rotating a conductor that is disposed within the lead.  
     
     
         16 . The apparatus of  claim 8 , wherein the at least one deployable lobe comprises a flange within the lead, and wherein the flange bends to form an angular shape that stretches the flexible material outwardly from the lead when the flange assumes the engaging position.  
     
     
         17 . The apparatus of  claim 16 , wherein the flange bends to form the angular shape by pushing a wire attached to one end thereof.  
     
     
         18 . The apparatus of  claim 16 , wherein the flange and flexible material engage the vessel when assuming the engaging position, thereby substantially fixating the lead within the vessel.  
     
     
         19 . The apparatus of  claim 8 , wherein the at least one deployable lobe comprises a flange that is attached to the lead at one end thereof by a hinge member, and wherein the flange rotates outwardly about the hinge member and stretches the flexible material outwardly from the lead when the flange assumes the engaging position.  
     
     
         20 . The apparatus of  claim 19 , wherein the flange rotates outwardly about the hinge member by pushing an outer tubing that surrounds the lead underneath the flange.  
     
     
         21 . The apparatus of  claim 20 , wherein an inner edge of the flange is sloped to facilitate the outward rotation of the flange when the outer tubing is engaged therewith.  
     
     
         22 . An apparatus for fixating a lead disposed within a vessel, comprising: 
 at least one deployable lobe situated on a distal portion of the lead, the deployable lobe adapted to assume a retracted position and an engaging position, the engaging position engaging the at least one deployable lobe with the vessel;    a lumen coupled to the deployable lobe, and adapted to extend the deployable lobe to the engaging position; and    wherein the at least one deployable lobe assumes the engaging position by extending outwardly from an outer surface of the lead.    
     
     
         23 . The apparatus of  claim 22 , wherein the deployable lobe takes the form of a balloon-like material.  
     
     
         24 . The apparatus of  claim 22 , wherein the deployable lobe is extended outwardly from the outer surface of the lead by inflation of the lobe via the lumen.  
     
     
         25 . The apparatus of  claim 24 , wherein the deployable lobe is extended outwardly from the outer surface of the lead by inflation of the lobe by injecting a gas or liquid into the lumen.  
     
     
         26 . The apparatus of  claim 22 , wherein the deployable lobe engages the vessel when assuming the engaging position, thereby substantially fixating the lead within the vessel.  
     
     
         27 . An apparatus for fixating a lead disposed within a vessel, the lead including an electrical conductor surrounded by a conductor tubing and an outer tubing that is slideably received over the conductor tubing, the apparatus comprising: 
 at least one deployable lobe situated on a distal portion of an outer surface of the conductor tubing of the lead, the deployable lobe adapted to assume a retracted position and an engaging position, the engaging position engaging the at least one deployable lobe with the vessel;    a recessed slot formed lengthwise within an inner surface of the outer tubing; and    wherein the at least one deployable lobe assumes the retracted position when the recessed slot formed within the outer tubing is in alignment with the deployable lobe and is slideably received within the recessed slot, and assumes an engaging position by extending outwardly from the outer surface of the conductor tubing when the deployable lobe is not in alignment with the recessed slot.    
     
     
         28 . The apparatus of  claim 27 , wherein the deployable lobe comprises a flexible strip, and wherein each end of the flexible strip is fixedly attached to the outer surface of the conductor tubing.  
     
     
         29 . The apparatus of  claim 27 , wherein the electrical conductor is rotated within the outer tubing to align or unalign the deployable lobe with the recessed slot formed lengthwise within the inner surface of the outer tubing.  
     
     
         30 . The apparatus of  claim 27 , wherein the engaging position of the deployable lobe is achieved by pushing the electrical conductor out from the outer tubing until the deployable lobe is exposed from the recessed slot, and rotating the electrical conductor until the deployable lobe is not in alignment with the recessed slot formed within the outer tubing.  
     
     
         31 . The apparatus of  claim 27 , wherein the retracted position of the deployable lobe is achieved by rotating the electrical conductor until the deployable lobe is in alignment with the recessed slot formed within the outer tubing and the deployable lobe is slideably received within the recessed slot.  
     
     
         32 . A method for fixating a lead disposed within a vessel, comprising: 
 providing a fixation segment surrounding the lead at a distal end thereof;    providing at least one deployable lobe situated on the fixation segment, the deployable lobe adapted to assume a retracted position and an engaging position, the engaging position engaging the at least one deployable lobe with the vessel; and    compressing the fixation segment to have the at least one deployable lobe assume the engaging position.    
     
     
         33 . A method for fixating a lead disposed within a vessel, comprising: 
 providing at least one deployable lobe situated on a distal portion of the lead, the deployable lobe adapted to assume a retracted position and an engaging position, the engaging position engaging the at least one deployable lobe with the vessel;    providing a flexible material covering a portion of an outer surface of the lead; and    extending the flexible material outwardly from the lead at the portion of the outer surface when the at least one deployable lobe assumes the engaging position.    
     
     
         34 . A method for fixating a lead disposed within a vessel, comprising: 
 providing at least one deployable lobe situated on a distal portion of the lead, the deployable lobe adapted to assume a retracted position and an engaging position, the engaging position engaging the at least one deployable lobe with the vessel; and    providing a lumen coupled to the deployable lobe, and adapted to extend the deployable lobe to the engaging position by extending outwardly from an outer surface of the lead.    
     
     
         35 . A method for fixating a lead disposed within a vessel, the lead including an electrical conductor surrounded by a conductor tubing and an outer tubing that is slideably received over the conductor tubing, the method comprising: 
 providing at least one deployable lobe situated on a distal portion of an outer surface of the conductor tubing of the lead, the deployable lobe adapted to assume a retracted position and an engaging position, the engaging position engaging the at least one deployable lobe with the vessel;    forming a recessed slot lengthwise within an inner surface of the outer tubing; and    retracting the deployable lobe when the recessed slot formed within the outer tubing is in alignment with the deployable lobe and is slideably received within the recessed slot, thereby assuming the retracted position; and    extending the deployable lobe outwardly from the outer surface of the conductor tubing when the deployable lobe is not in alignment with the recessed slot and is withdrawn therefrom, thereby assuming the engaging position.    
     
     
         36 . The method of  claim 35  wherein a slip anti-coagulant (heparin) coating is used on the conductor tubing.  
     
     
         37 . The method of  claim 35  wherein the lobes are annealed to enable deployment in an engaging position.