Lead delivery device and method

• US 9,849,279 B2
• Filed: 07/31/2008
• Issued: 12/26/2017
• Est. Priority Date: 06/27/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tobin, Lindsey Marie, Asleson, Andrea Jean, Waldhauser, Steven Lawrence, Hayden, Scott William, Yasger, Kendra, Drake, Ronald Alan
• Primary Examiner(s): Lee, Erica
• Application Number:
  US12/183,105
• Publication Number:
  US 20090326630A1
• Time in Patent Office: 3,435 Days
• Field of Search: 607122, 607125, 607127, 600381, 600585, 60410306
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A medical apparatus includes an electrically conductive lead for a medical device, the lead having an internal bore terminating at a distal lead opening, and a lead delivery device for delivering the distal end of the lead to a blood vessel during implantation of the lead. The lead delivery device includes a removably anchorable guidewire, and a fixator attached to a distal portion of the guidewire for anchoring the guidewire. The fixator is movable between a compact configuration and an expanded configuration. The fixator is capable of passing through the distal lead opening of the lead in the compact configuration. The fixator is capable of exerting a holding force in the range of about 0.89 to 4.45 N in the lumen of the blood vessel in the expanded configuration.

Claims

1. A medical method comprising:

providing an electrically conductive lead of a medical device comprising a distal tip portion and a lumen defined thereby terminating at a distal opening defined at the distal tip portion;

inserting a distal end of a cannulated catheter through cardiac tissue into a main cardiac vessel, wherein the distal end of the cannulated catheter terminates in a tip opening;

inserting a lead delivery device through the catheter and out the tip opening of the distal end thereof into the main cardiac vessel, the lead delivery device including a guidewire and a fixator coupled to the guidewire in proximity to a distal tip of the guidewire, wherein the fixator is configurable in a deployed expanded shape having a width greater than the tip opening of the distal end of the catheter and an undeployed compact shape having a width less than the tip opening of the distal end of the catheter and less than the distal opening defined at the distal tip portion of the electrically conductive lead;

advancing the inserted lead delivery device to a target site in a branching vessel with the fixator configured in the undeployed compact shape;

deploying the fixator, after the fixator in the undeployed compact shape has been advanced beyond the tip opening of the cannulated catheter, to the deployed expanded shape having multiple contact surfaces such that the multiple contact surfaces can press against an internal lumen of the branching vessel with a holding fixation force to temporarily anchor the guidewire of the advanced lead delivery device in the branching vessel, the holding fixation force being of an amount that allows the guidewire to be pulled in tension without being dislodged from the internal lumen of the branching vessel while the electrically conductive lead of the medical device is pushed over the guidewire, the contact surfaces of the deployed expanded shape being longitudinally offset from one another and on opposite sides of a longitudinal axis of the guidewire;

removing the catheter, as well as any and all other catheters, from around the anchored guidewire, prior to pulling and tensioning the anchored guidewire while pushing the electrically conductive lead of the medical device over the guidewire and to the target site;

pulling and tensioning the anchored guidewire while pushing the electrically conductive lead of the medical device over the guidewire and to the target site, after removing any and all catheters;

returning the fixator to the undeployed compact shape, after pushing the lead to the target site; and

retracting the fixator through the distal opening defined at the distal tip portion and through the lumen of the electrically conductive lead and alongside an internal conductive coil of the electrically conductive lead within the lumen, after returning the fixator to the undeployed compact shape, wherein the fixator is returned to the undeployed compact shape before the fixator in the undeployed compact shape is retracted through the distal opening defined at the distal tip portion of the electrically conductive lead.

2. The method of claim 1, wherein the holding fixation force is equal to or greater than about 2.24 N.

3. The method of claim 2, wherein pushing the lead over the guidewire comprises advancing the lead in a climbing manner.

4. The method of claim 1, wherein the deployed expanded shape of the fixator has a width of approximately 5 mm.

5. The method of claim 1, wherein returning the fixator to the undeployed compact shape comprises contracting the fixator to a compact width equal to or less than approximately 0.483 mm.

6. The method of claim 1, further comprising:

advancing the inserted lead delivery device to another site in the branching vessel outside of the lumen of the lead;

deploying the fixator to the deployed expanded shape having multiple contact surfaces to temporarily anchor the guidewire of the advanced delivery device to the another site in the branching vessel;

pulling and tensioning the anchored guidewire while pushing the electrically conductive lead of the medical device over the guidewire and to the another site in the branching vessel;

returning the fixator to an undeployed compact shape after pushing the electrically conductive lead to the another site in the branching vessel; and

retracting the fixator through the lumen of the electrically conductive lead and alongside an internal conductive coil of the electrically conductive lead within the lumen after pushing the electrically conductive lead to the another site in the branching vessel and returning the fixator to the undeployed compact shape.

7. The method of claim 1, further comprising advancing the electrically conductive lead of the medical device more distally in the branching vessel beyond the target site after removal of the guidewire.

8. The method of claim 1, wherein the multiple contact surfaces of the expanded shape of the fixator have a symmetrical profile.

9. The method of claim 1, wherein the multiple contact surfaces of the expanded shape of the fixator have a non-symmetrical profile.