COMPOUND-SHAPED STYLET FOR TORQUE TRANSMISSION

• US 20140058405A1
• Filed: 03/18/2013
• Published: 02/27/2014
• Est. Priority Date: 08/27/2012
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Foster, Arthur J.
• Granted Patent: US 9,550,058 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0592 Introducing the lead through the pericardium with a needle
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

A medical stylet for guiding a lead includes a first elongate member for attachment of the lead to the target tissue, a second elongate member to reshape the lead. The first elongate member of the medical stylet includes a proximal end portion, and a distal end portion wherein the distal end portion of the first elongate member includes a tip feature configured to engage the lead on application of torque externally. The second elongate member defines a lumen along its length. The lumen of the second elongate member can be configured to enclose at least a portion of the first elongate member. The second elongate member can have a pre defined shape. The pre defined shape of the second elongate member allows the lead to be reshaped when inserted into the lead, this reshaped lead now can be guided to an anatomical pass way.

Claims

1. A medical stylet for use in delivering and anchoring an implantable medical lead to a desired location near or in a patient'"'"'s heart, the medical stylet comprising:

an inner member, having a distal end portion and a proximal end portion, wherein the distal end portion includes a tip feature, the tip feature configured to rotationally engage a coupling feature at or near a distal end of the implantable medical lead, the coupling feature rotationally coupled to an anchoring mechanism including a fixation feature; and

an outer member defining a lumen along its length, the lumen configured to accept and allow rotation of at least a portion of inner member, the outer member having a predetermined shape and having sufficient stiffness to impart the shape upon the lead, the shape selected to assist in delivery of the lead to the desired implant location;

wherein the inner member has sufficient torsional stiffness to transmit a torque from the proximal end portion to the coupling feature, so as to rotate the anchoring mechanism.

2. The medical stylet of claim 1, further comprising an actuating mechanism and wherein the proximal end portion of the inner member is configured to be rotated by the actuating mechanism.

3. The medical stylet of claim 2, wherein the tip feature is configured to be manipulated by the actuating mechanism to engage with the coupling feature of the implantable medical lead.

4. The medical stylet of claim 1, wherein the inner member is made from at least one of steel, titanium, nickel, and a polymer.

5. The medical stylet of claim 1, wherein the tip feature of the inner member defines a non-circular shape.

6. The medical stylet of claim 1, wherein the predetermined shape of the outer member is a J-shape and the desired location in an atrium of the heart.

7. The medical stylet of claim 1, wherein the predetermined shape of the outer member is an L-shape and the desired location is a His bundle of the heart.

8. The medical stylet of claim 1, wherein the predetermined shape is a multi-planar shape.

9. The medical stylet of claim 1, wherein the outer member is made from at least one of a stainless steel and a nickel-cobalt alloy.

10. The medical stylet of claim 1, wherein the inner member has a torsional stiffness sufficient to deliver a torque to the coupling feature, with less than 360 degrees rotation along its length, in an amount between about 20 and about 100 micronewton-meters.

11. A cardiac lead assembly comprising:

an implantable medical lead including a lead body having a lead proximal end and a lead distal end and a lead lumen extending therethrough, the lead further including an anchoring mechanism disposed at or near the lead distal end, the anchoring mechanism having a coupling feature and a fixation feature;

a stylet for use in guiding the implantable lead to a desired implant site, the stylet comprising;

an inner member, having a distal end portion and a proximal end portion, wherein the distal end portion includes a tip feature, the tip feature configured to rotationally engage the coupling feature at or near the distal end of the implantable medical lead; and

an outer member defining a stylet lumen along its length, the stylet lumen configured to accept and allow rotation of at least a portion of inner member, the outer member having a predetermined shape and having sufficient stiffness to at least partially impart the shape upon the lead, the shape selected to assist in delivery of the desired implant site;

wherein the inner member has sufficient torsional stiffness to transmit a torque from the proximal end portion to the coupling feature, so as to rotate the anchoring mechanism.

12. The cardiac lead assembly of claim 11, wherein the inner member is made from at least one of steel, titanium, nickel, and a polymer.

13. The cardiac lead assembly of claim 11, wherein the tip feature of the inner member defines a non-circular shape.

14. The cardiac lead assembly of claim 11, wherein the anchoring mechanism includes a helix configured for engaging and anchoring with tissue in or near a patient'"'"'s heart.

15. The cardiac lead assembly of claim 11, wherein the predetermined shape is a multi-planar shape.

16. The cardiac lead assembly of claim 11, wherein the outer member is made from at least one of a stainless steel and a nickel-cobalt alloy.

17. The cardiac lead assembly of claim 11, wherein the inner member has a torsional stiffness sufficient to deliver a torque to the coupling feature, with less than 360 degrees rotation along its length, in an amount between about 20 and about 100 micronewton-meters.

18. The cardiac lead assembly of claim 11, wherein the fixation feature is a fixation helix.

19. A method of placing a lead in an anatomical location, using a medical stylet, the method comprising:

inserting the medical stylet into a lumen defined by the lead, the medical stylet including an inner member, and an outer member at least partially surrounding the inner member, the outer member configured for providing a shape to the lead in accordance with an anatomical passageway;

wherein the lead includes an anchoring mechanism having a coupling feature;

guiding the stylet along the anatomical passageway to the anatomical location; and

rotating the medical stylet so as to cause the inner member to impart torque upon the coupling feature thereby causing the anchoring mechanism to rotate and engage tissue to anchor the lead at the anatomical location.

20. The method of claim 19, further comprising retracting the medical stylet after anchoring the lead at the anatomical location.