DELIVERY SYSTEM ASSEMBLIES AND ASSOCIATED METHODS FOR IMPLANTABLE MEDICAL DEVICES

• US 20140249543A1
• Filed: 05/12/2014
• Published: 09/04/2014
• Est. Priority Date: 11/17/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Berthiaume, William A., Tran, Don H., Griswold, Erik, Locsin, Brent L., Steingisser, H. Allan
• Granted Patent: US 9,867,982 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

A delivery system assembly includes an elongate outer tube, an elongate inner member extending within a lumen of the outer tube, and an articulation sheath surrounding the outer tube between a handle of the assembly and a distal-most portion of the outer tube. The outer tube is longitudinally moveable within the sheath; and an inner diameter of the sheath is preferably smaller than that of the handle and the distal-most portion of the outer tube. Navigation of the assembly through a venous system, for deployment of an implantable medical device, is facilitated by deflection of the sheath, to orient a distal-most portion of the outer tube, within which an entirety of the medical device is contained/loaded, and by subsequent advancement of the distal-most portion, with respect to the sheath, to move the distal end of the inner member, along with the contained/loaded device into proximity with a target implant site.

Claims

1. A method for navigating a delivery system assembly through a venous system of a patient for deployment of an implantable medical device, the method comprising:

loading an entirety of the implantable medical device into a distal-most portion of an outer tube of a delivery system assembly such that a proximal end of the medical device abuts a distal end of an inner member of the delivery system assembly, the inner member extending within a lumen formed by the outer tube;

advancing the delivery system assembly within a venous system of a patient to locate the distal-most portion of the outer tube, with the medical device loaded therein, within a right atrium of the patient;

orienting the located distal-most portion of the outer tube toward a tricuspid valve of the patient by deflecting a distal end of a sheath of the delivery system assembly, the sheath extending around the outer tube such that the distal end of the sheath is positioned proximal to the distal-most portion of the outer tube; and

advancing, with respect to the deflected distal end of the sheath, the distal-most portion of the outer tube through the tricuspid valve and into a right ventricle of the patient to a target implant site, such that the distal-most portion of the outer tube abuts the target implant site, the advancing carrying the distal end of the inner member and the loaded medical device along with the distal-most portion, by means of an engagement of the distal end of the inner member within the lumen of the outer tube.

2. The method of claim 1, wherein orienting the located distal-most portion of the outer tube by deflecting the distal end of the sheath comprises actuating a pull-wire member of the sheath, the pull-wire member having a distal end anchored in proximity to the distal end of the sheath.

3. The method of claim 2, further comprising securing a locking member of the sheath after actuating the pull-wire member, the secured locking member holding a pulled tension in the actuated pull-wire member to maintain the deflection of the sheath while advancing the distal-most portion of the outer tube.

4. The method of claim 1, wherein orienting the located distal-most portion by deflecting the distal end of the articulation sheath comprises releasing a distal segment of the sheath from a straightened configuration to a pre-formed curvature.

5. The method of claim 4, wherein releasing the distal segment comprises withdrawing a straightening mandrel from a position within a lumen of the inner member.

6. The method of claim 1, wherein advancing the distal-most portion of the outer tube comprises using a handle of the delivery system assembly to push the outer tube in a distal direction relative to the sheath.

7. The method of claim 1, further comprising deflecting the inner member to further orient the distal-most portion of the outer tube, during or after advancing the distal-most portion into the right ventricle.

8. The method of claim 1, further comprising retracting the outer tube, relative to both the sheath and the inner member after the distal-most portion abuts the target implant site.