US2017333698A1PendingUtilityA1

Introduction of medical lead into patient

Assignee: MEDTRONIC INCPriority: Jan 29, 2010Filed: Aug 4, 2017Published: Nov 23, 2017
Est. expiryJan 29, 2030(~3.5 yrs left)· nominal 20-yr term from priority
A61N 1/0573A61N 1/0551A61N 1/0531A61N 1/0558A61N 1/048A61N 1/372A61N 1/05A61B 17/3468A61N 1/0587A61N 1/0592A61N 1/056A61B 17/00
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Claims

Abstract

Introducers for implanting a lead having a fixation element distal to an electrode include a window, electrode, or conductive member alignable with the electrode of the lead while maintaining the fixation element in a retracted configuration. The window, electrode or conductive member of the introducer provide a mechanism for applying test stimulation signals to determine whether the lead is properly positioned in a patient without deploying the fixation element.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A system comprising:
 a lead having a self-deployable fixation element and a first electrode for delivering an electrical signal to a patient,   wherein the fixation element is located on the lead distal to the first electrode; and   an introducer having a body member defining a lumen extending from a proximal end of the body member to a distal end of the body member, and a first opening in the body member in communication with the lumen,   wherein the lead is slidably disposable in the lumen of the body member and positionable in the lumen such that the first electrode is aligned with the first opening while the fixation element is retained in a retracted configuration by a portion of the body member distal the first opening.   
     
     
         2 . The system of  claim 1 , wherein the lead further comprises a second electrode, wherein the first electrode is located distally on the electrode relative to the second electrode. 
     
     
         3 . The system of  claim 2 , wherein the lead is positionable in the lumen such that the first and second electrodes are aligned with the first opening. 
     
     
         4 . The system of  claim 2 , wherein the introducer further comprises a second opening in the body member in communication with the lumen, wherein the lead is positionable in the lumen such that the first electrode is aligned with the first opening and the second electrode is aligned with the second opening while the fixation element is retained in a retracted configuration by a portion of the body member distal the first opening. 
     
     
         5 . A method for implanting a lead having an electrode and a fixation element distal the electrode, comprising:
 inserting a distal portion of an introducer into a tissue of a patient, the introducer having a tubular body member defining a lumen and a window in the body member in communication with the lumen;   advancing the lead in the lumen of the introducer until the electrode is aligned with the lead; and   withdrawing the introducer over the lead to deploy the fixation element of the lead, leaving the lead implanted in the patient.   
     
     
         6 . The method of  claim 5 , further comprising:
 applying a test electrical signal to the tissue via the electrode through the window; and   determining whether the electrode is in the desired location based on the test signal.   
     
     
         7 . The method of  claim 6 , further comprising moving the position of the introducer and the lead in the patient if the electrode is determined to be in an undesired location based on the test signal. 
     
     
         8 . A system comprising:
 a lead having a fixation element and a first electrode for delivering an electrical signal to a patient,   wherein the fixation element is located on the lead distal to the first electrode; and   an introducer having (i) a body member defining a lumen extending from a proximal end of the body member to a distal end of the body member, and (ii) a first introducer electrode located between the proximal and distal ends of the body member,   wherein the lead is slidably disposable in the lumen of the body member and positionable in the lumen such that the first electrode of the lead is aligned with the first introducer electrode while the fixation element is retained in a retracted configuration by a portion of the body member distal the first introducer electrode.   
     
     
         9 . The system of  claim 8 , wherein the lead further comprises a second electrode, wherein the first electrode is located distally on the electrode relative to the second electrode, wherein the introducer further comprises a second electrode disposed between the proximal and distal ends of the body member, and wherein the lead is positionable in the lumen such that when the first electrode of the lead is aligned with the first introducer electrode, the second electrode of the lead is aligned with the second electrode of the introducer. 
     
     
         10 . A method for implanting a lead having an electrode and a fixation element distal to the electrode, comprising:
 inserting a distal portion of an introducer into a tissue of a patient, the introducer having (i) a tubular body member having a proximal end and a distal end and defining a lumen extending from the proximal end to the distal end, and (ii) an electrode between proximal and distal ends of the body member;   advancing the lead in the lumen of the introducer until the electrode is aligned with the electrode of the introducer; and   withdrawing the introducer over the lead to deploy the fixation element of the lead, leaving the lead implanted in the patient.   
     
     
         11 . The method of  claim 10 , further comprising:
 applying a test electrical signal to the tissue via the electrode of the introducer; and   determining whether the electrode of the introducer is in the desired location based on the test signal.   
     
     
         12 . The method of  claim 11 , further comprising moving the position of the introducer and the lead in the patient if the electrode is determined to be in an undesired location based on the test signal. 
     
     
         13 . An introducer for implanting a lead having an electrode and a fixation element distal to the electrode, comprising:
 a body member defining a lumen extending from a proximal end of the body member to a distal end of the body member, and   an introducer electrode located between the proximal and distal ends of the body member,   wherein the introducer is configured to slidably receive the lead in the lumen and is configured such that the lead is positionable in the lumen at a location where the electrode of the lead is aligned with the introducer electrode while the fixation element is retained in a retracted configuration by a portion of the body member distal the introducer electrode, and   wherein the introducer is configured such that the tubular body member may be withdrawn over the lead to deploy the fixation element.

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