US 7,930,040 B1Granted

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

Minimally invasive introducers and methods that can be used for rotationally securing devices within the human body. Introducers 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.

Claims45

Dependent claims

A device for rotating and inserting an electrode of a lead into body tissue to be stimulated, the device comprising:

a) a shaft having a length extending along a longitudinal axis from a proximal shaft portion to a distal shaft portion;
b) a rotatable tube disposed over at least the distal shaft portion and having a distal tube portion, wherein the tube is rotatable about the longitudinal axis of the shaft while the shaft remains relatively stationary;
c) a first distal member pivotally coupled to the distal shaft portion;
d) a second distal member rotatably coupled to the pivotable first distal member, wherein the second distal member is actuable for releasably engaging the lead electrode;
e) a first push/pull wire extending from the proximal shaft portion to the first distal member for effecting pivotable movement thereof relative to the shaft;
f) a second push/pull wire extending from the proximal shaft portion to the second distal member for effecting releasable engagement thereof with the lead electrode;
g) a drive member having a proximal drive portion in a contact relationship with the distal tube portion of the rotatable tube and having a distal drive portion in a contact relationship with the second distal member;
and
h) wherein the tube is rotatable to rotate the drive member and consequently the second distal member while the first distal member pivotally coupled to the shaft remains relatively stationary.

6 more elements

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:
a shaft having a length extending along a longitudinal axis from a proximal shaft portion to a distal shaft portion;
a rotatable tube disposed over at least the distal shaft portion and having a distal tube portion, wherein the tube is rotatable about the longitudinal axis of the shaft while the shaft remains relatively stationary;
a hinge pivotally coupled to the distal shaft portion;
a collet rotatably coupled to the hinge, wherein the collet is actuable for releasably engaging the lead electrode;
a first push/pull wire extending from the proximal shaft portion to the hinge for effecting pivotable movement thereof relative to the shaft;
a second push/pull wire extending from the proximal shaft portion to the collet for effecting releasable engagement thereof with the lead electrode;
a drive spring having a proximal drive portion in a contact relationship with the distal tube portion of the rotatable tube and having a distal drive portion in a contact relationship with the collet;
and wherein the tube is rotatable to rotate the drive spring and consequently the collet while the hinge pivotally coupled to the shaft remains relatively stationary;
b) manipulating the proximal portion of the second push/pull wire to cause the distal portion thereof to move the collet 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 first push/pull wire to pivot the hinge rotatably coupled to the collet relative to the shaft to thereby orient the collet and the lead electrode into a position for securing the electrode to the body tissue;
e) manipulating the rotatable tube to thereby rotate the drive spring and the collet 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 second push/pull wire to cause the collet to release from the lead electrode;
and
g) removing the device from the incision or body port.

13 more elements

Dependencies are inferred from the claim text.

Facts

Application: 12/478,301Filed 4 Jun 2009 · division
Priority: 6 May 2003
Granted: 19 Apr 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 7,930,040 B1This patent

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