US 7,890,192 B1Granted

Method for inserting a lead electrode into body tissue using a rotatable lead introducer

AssigneeGreatbatch Ltd.

InventorsDaniel N. Kelsch, James L. Mellor, Kenneth P. Rundle, Roger B. Fell, Scott E. Jahns, Dave S. Erickson, Vincent A. Fischer, III, Kent D. Anderson

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Abstract

A method for inserting a lead electrode into body tissue using a rotatable lead introducer is described. The introducer can include a distal element for releasably engaging a lead head controllable from a proximal control located outside of the body. An inner stem can extend between a proximal portion and a distal portion, and be pivotally and rotatably coupled to the distal lead engagement mechanism. An outer tube can be rotatably disposed over the inner stem and be flexibly coupled over the pivot to rotationally drive the distal element. A helical epicardial-myocardial lead electrode can be secured and oriented straight ahead and introduced through a port or small incision with the introducer in a straight configuration. The introducer can then be bent and rotated to screw the helical electrode into the heart.

Claims23

Dependent claims

A method for inserting an electrode of a lead into a body tissue intended to be stimulated, comprising the steps of:

a) providing a device comprising:
an elongate shaft having a proximal portion and a distal portion;
a first distal member pivotally coupled to the elongate shaft distal portion;
a second distal member rotatably coupled to the first distal member, wherein the second distal member includes a portion for releasably engaging the electrode;
a rotatable tube having a proximal portion and a distal portion, the tube being disposed around the elongate shaft and rotatably flexibly coupled over the first distal member pivotal coupling to the second distal member;
a first elongate member having a distal region actuatably coupled to the second distal member portion for releasably engaging the electrode, and having a proximal portion actuable from the shaft proximal portion to release the electrode;
and a second elongate member having a distal region operably coupled to the first or the second distal member for causing the first distal member to pivot relative to the elongate shaft, and having a proximal portion actuable from the shaft proximal portion;
b) manipulating the proximal portion of the first elongate member to cause the distal portion thereof to move the second distal member into releasable engagement with a lead electrode;
c) advancing the device including the lead through an incision or port in a human body until the lead electrode is proximate the body tissue;
d) manipulating the proximal portion of the second elongate member to pivot the first distal member rotatably coupled to the second distal member relative to the shaft to thereby orient the second distal member and the lead electrode into a position for securing the electrode to the body tissue;
e) manipulating the rotatable tube to thereby rotate the first distal member rotatably coupled to the second distal member releasably engaged with the lead electrode to thereby cause the electrode to screw into the body tissue;
f) further manipulating the proximal portion of the first elongate member to cause the second distal member to release from the lead electrode;
and
g) removing the device from the incision or body port.

11 more elements

A method for inserting an electrode of a lead into body tissue to be stimulated, comprising the steps of:

a) providing a device comprising:
an elongate shaft having a proximal portion and a distal portion;
a hinge having a proximal portion coupled to the elongate shaft distal portion, and a distal portion;
a lead grasping member rotatably coupled to the hinge distal portion and including jaws configured and dimensioned to releasably grasp the lead, and an internal camming surface of the jaws;
a camming element disposed within the lead grasping member and biased to apply force to the camming surface to open the jaws;
a first elongate member having a distal region coupled to the camming element to reduce the bias when the first elongate member is proximally retracted, and a proximal portion actuatable from the device proximal portion;
a second elongate element having a distal region operably coupled to the hinge distal portion and a proximal region actuatable from the device proximal portion;
and a tube rotatably disposed over the elongate shaft and rotatably coupled to the lead grasping member over the hinge;
b) manipulating the proximal portion of the first elongate member to cause the distal portion thereof to cause the camming element disposed within the lead grasping element to apply a biasing force against the camming surface to open the jaws and then further manipulating the first elongate member to reduce the biasing force of the camming element against the camming surface to close the jaws on the lead electrode;
c) advancing the device including the lead through an incision or port in a human body until the lead electrode is proximate the body tissue;
d) manipulating the proximal portion of the second elongate member to pivot the hinge relative to the shaft to thereby orient the lead grasping member and the lead electrode into a position for securing the electrode to the body tissue;
e) manipulating the rotatable tube to thereby rotate the lead grasping element releasably engaged with the lead electrode relative to the shaft to thereby cause the electrode to screw into the body tissue;
f) further manipulating the proximal portion of the first elongate member to increase the biasing force of the camming element against the camming surface of the lead grasping member to thereby open the jaws and release the lead electrode from the lead grasping member;
and
g) removing the device from the incision or body port.

12 more elements

Dependencies are inferred from the claim text.

Facts

Application: 12/478,797Filed 5 Jun 2009 · division
Priority: 6 May 2003
Granted: 15 Feb 2011
Term ends: Not estimatedThe source records don’t support an estimate.

Classification13 codes

A61N 1/0587
For implantation or insertion into the body, e.g. heart electrode: epicardial electrode systems; Endocardial electrodes piercing the pericardium
A61B 17/8888
Holding the screw head: at its central region
B25B 27/143
For assembling objects other than by press fit or detaching same: for installing wire thread inserts or tubular threaded inserts
A61B 2017/00243
Type of minimally invasive operation: cardiac

Family

Application60/468,352Us provisional application · filed 6 May 2003
Application10/840,668Parent of this division · filed 6 May 2004
US 7,544,197 B2Parent of this division
US 2005/0004644 A1Published application
US 7,890,192 B1This patent

From the US filing history. Foreign family members aren’t listed.