Delivery system assemblies and associated methods for implantable medical devices

• US 9,867,982 B2
• Filed: 05/12/2014
• Issued: 01/16/2018
• 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, Steingisser, H Allan, Tran, Don H, Griswold, Erik, Locsin, Brent L
• Primary Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US14/275,270
• Publication Number:
  US 20140249543A1
• Time in Patent Office: 1,345 Days
• Field of Search: 604528, 604532, 6048911, 606108, 606129, 606194, 623 111, 623 123, 623 211
• 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;

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; and

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.

3. 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.

4. 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.

5. 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.

2. 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;

wherein orienting the located distal-most portion by deflecting the distal end of the sheath comprises releasing a distal segment of the sheath from a straightened configuration to a pre-formed curvature; and

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 2, 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 2, 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 2, 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.