DELIVERY SYSTEM ASSEMBLIES AND ASSOCIATED METHODS FOR IMPLANTABLE MEDICAL DEVICES

• US 20130103047A1
• Filed: 10/24/2011
• Published: 04/25/2013
• Est. Priority Date: 10/24/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Steingisser, H. Allan, Berthiaume, William A., Locsin, Brent L., Tran, Don H.
• Granted Patent: US 8,945,146 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• 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 outer tube, an inner member, extending within a lumen of the outer tube, and a deflectable shaft, extending within the outer tube lumen and around the inner member; the tube and inner member are longitudinally moveable with respect to the shaft, and a distal end of the inner member is located distal to the shaft within the tube lumen. A medical device can be loaded into the tube lumen, along a distal-most portion of the tube, and contained between the inner member and a distal opening of the tube lumen. Deflecting the shaft orients the distal-most portion for navigation of the assembly, and, when the distal end of the inner member is engaged within the tube lumen, distal movement of the tube, with respect to the shaft, causes similar distal movement of the inner member and the loaded medical device toward an implant site.

Claims

1. A delivery system assembly facilitating deployment of an implantable medical device, the assembly comprising:

a handle including a first control member and a second control member;

an elongate shaft extending distally from the handle, the shaft including a proximal end fixed within the handle, a deflectable distal end, a lumen extending from a proximal opening thereof at the proximal end to a distal opening thereof at the distal end, and a pull wire, the pull wire including a proximal end coupled to the first control member of the handle and a distal end anchored to the deflectable distal end of the shaft, the first control member for deflecting the shaft via the pull wire;

an elongate inner member including an enlarged distal end, the inner member extending within the lumen of the shaft and distally from the distal opening of the shaft lumen to the enlarged distal end, the inner member being longitudinally moveable with respect to the shaft, and the enlarged distal end of the inner member being configured to conform to a proximal end of the medical device; and

an elongate outer tube extending distally from the handle and forming a lumen in which the shaft and the inner member extend such that an entirety of the outer tube is longitudinally moveable with respect to the shaft by means of the second control member of the handle, which is coupled to the outer tube, the outer tube including an internal shoulder and a distal-most portion that has a length, along which the lumen of the outer tube extends from the internal shoulder to a distal opening of the lumen, and the lumen of the outer tube, along the length of the distal-most portion, being sized to contain both the enlarged distal end of the inner member and an entirety of the implantable medical device; and

wherein, when the enlarged distal end of the inner member is contained within the lumen of the outer tube, along the length of the distal-most portion, and abuts the internal shoulder of the outer tube, and the outer tube is moved longitudinally in a distal direction, the inner member is also moved longitudinally in the distal direction with respect to the shaft.

2. The assembly of claim 1, wherein the configuration of the lumen along the length of the distal-most portion of the outer tube allows longitudinal movement of the outer tube with respect to the inner member, so that the enlarged distal end of the inner member can be located outside the lumen of the outer tube, distal to the distal opening of the lumen of the outer tube.

3. The assembly of claim 2, wherein the inner member is longitudinally moveable with respect to the outer tube.

4. The assembly of claim 1, wherein a maximum distance over which the outer tube is longitudinally moveable in the distal direction is approximately 10 cm.

5. The assembly of claim 1, wherein the handle further includes a third control member, the inner member further includes a proximal end coupled to the third control member, and the inner member is longitudinally moveable with respect to the outer tube by means of the control member.

6. The assembly of claim 1, wherein the outer tube is rotatable with respect to the handle, about a central longitudinal axis thereof.

7. The assembly of claim 1, wherein the enlarged distal end of the inner member is radiopaque.

8. The assembly of claim 1, wherein:

the handle further includes a third control member; and

the inner member further includes a pull wire, the inner member being deflectable, in proximity to the enlarged distal end thereof, by means of the pull wire thereof, the pull wire of the inner member having a proximal end coupled to the third control member of the handle and a distal end anchored in proximity to the enlarged distal end of the inner member.

9. The assembly of claim 1, further comprising a tether;

and wherein;

the inner member includes a proximal end and a lumen that extends from a proximal opening thereof at the proximal end of the inner member to a distal opening thereof at the enlarged distal end of the inner member; and

the tether extends within the lumen of the inner member from the proximal opening to the distal opening thereof, the tether being configured for removable attachment to the medical device in proximity to the distal opening of the lumen of the inner member.

10. The assembly of claim 1, further comprising an overlay surrounding the outer tube in proximity to the handle, the overlay being slidable over the outer tube for repositioning of the overlay with respect to the handle.

11. A delivery system assembly facilitating deployment of an implantable medical device, the assembly comprising:

an elongate outer tube forming a lumen that extends from a proximal opening thereof at a proximal end of the outer tube to a distal opening thereof at a distal end of the tube, the lumen being sized to contain an entirety of the medical device therein in proximity to the distal opening thereof;

an elongate inner member extending within the lumen of the outer tube, the inner member including a proximal end and a distal end, the distal end of the inner member being configured to conform to a proximal end of the medical device and to engage within the lumen of the outer tube in proximity to the distal opening thereof at a location allowing the entirety of the medical device to fit between the distal end of the inner member and the distal opening of the lumen of the outer tube; and

an elongate deflectable shaft extending within the lumen of the outer tube and around the inner member, the deflectable shaft including a distal end located proximal to the distal end of the inner member;

wherein the outer tube and the inner member are longitudinally moveable, with respect to the deflectable shaft, and, when the distal end of the inner member is engaged within the lumen of the outer tube, longitudinal movement of the outer tube, in a distal direction, causes similar distal movement of the distal end of the inner member.

12. The assembly of claim 11, wherein the distal end of the inner member is disengaged from within the lumen of the outer tube when the outer tube is moved longitudinally, in a proximal direction.

13. The assembly of claim 11, wherein the outer tube is also moveable with respect to the inner member.

14. The assembly of claim 11, wherein the inner member is also moveable with respect to the outer tube.

15. The assembly of claim 11, further comprising a tether;

and wherein;

the inner member includes a lumen that extends from a proximal opening thereof at the proximal end of the inner member to a distal opening thereof at the distal end of the inner member; and

the tether extends within the lumen of the inner member from the proximal to the distal opening thereof, the tether being configured for removable attachment to the medical device in proximity to the distal opening of the lumen of the inner member.

16. A method for deploying an implantable cardiac 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 shaft of the delivery system assembly, the shaft extending within the lumen of the outer tube and around the inner member such that the distal end of the shaft is positioned proximal to the distal end of the inner member;

advancing, with respect to the deflected distal end of the shaft, 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 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; and

retracting the outer tube with respect to the distal end of the inner member and the shaft to expose a fixation member of the medical device for engagement of tissue at the implant site.

17. The method of claim 16, further comprising:

attaching a tether to the proximal end of the implantable medical device when loading the device into the distal-most portion of the delivery system assembly;

threading the tether through a lumen of the inner member such that terminal ends of the tether are accessible at a proximal end of the delivery system assembly;

withdrawing the inner member along the tether and away from the medical device, after retracting the outer tube; and

tugging on the tether to test engagement of the fixation member of the medical device, after withdrawing the inner member.

18. The method of claim 17, further comprising:

evaluating a function of the medical device, after tugging on the proximal portion of the tether and if the tugging indicates engagement of the fixation member of the device; and

if the evaluated function is not acceptable, re-loading the device into the distal-most portion of the outer tube of the delivery system assembly by;

advancing the inner member back toward the medical device so that the proximal end of the device abuts the distal end of the inner member while pulling on the proximal portion of the tether to remove any slack in the tether; and

advancing the outer tube over the shaft and the inner member until both the distal end of the inner member and an entirety of the medical device are contained within the distal-most portion of the outer tube; and

repositioning the delivery system assembly and the re-loaded medical device such that the distal-most portion of the outer tube abuts another target implant site.

19. The method of claim 18, wherein the repositioning comprises re-orienting the distal-most portion of the outer tube of the delivery system assembly by adjusting the deflection of the shaft of the delivery system assembly.

20. The method of claim 18, further comprising deflecting the inner member, in proximity to the distal end thereof, the deflecting of the inner member to further orient the distal-most portion of the outer tube prior to, or in conjunction with, advancing the distal-most portion to the target implant site or to the other target implant site.

21. The method of claim 18, further comprising rotating the outer tube to further orient the distal-most portion of the outer tube prior to, or in conjunction with, advancing the distal-most portion to the target implant site or to the other target implant site.

22. The method of claim 16, further comprising deflecting the inner member, in proximity to the distal end thereof, the deflecting of the inner member to further orient the distal-most portion of the outer tube prior to, or in conjunction with, advancing the distal-most portion to the target implant site.

23. The method of claim 16, further comprising rotating the outer tube to further orient the distal-most portion of the outer tube prior to, or in conjunction with, advancing the distal-most portion to the target implant site.

24. The method of claim 16, further comprising positioning an overlay of the delivery system to coincide with a valve of an introducer sheath through which the delivery system assembly is advanced, after advancing the delivery system assembly within the venous system and prior to advancing the distal-most portion of the outer tube through the tricuspid valve, the overlay being slideable over the outer tube and, when positioned, providing an enhanced interface between the valve of the introducer sheath and the delivery system assembly.