DELIVERY SYSTEM ASSEMBLIES AND ASSOCIATED METHODS FOR IMPLANTABLE MEDICAL DEVICES

• US 20130131591A1
• Filed: 11/17/2011
• Published: 05/23/2013
• 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.
• Granted Patent: US 8,721,587 B2
• Time in Patent Office: Days
• US Class Current: 604/95.04
• 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 delivery system assembly facilitating deployment of an implantable medical device, the assembly comprising:

a handle including at least one control member;

an elongate outer tube extending distally from the handle and 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 outer tube, the proximal end of the outer tube being coupled to one of the at least one control member of the handle, the outer tube being longitudinally moveable relative to the handle, via the control member, and the outer tube including a distal-most portion having a length along which the lumen is sized to contain an entirety of the medical device therein, the distal opening of the lumen allowing passage of the medical device therethrough for the deployment;

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 being configured to conform to a proximal end of the implantable medical device and to engage within the distal-most portion of the outer tube at a location that allows the engaged distal end of the inner member and the entirety of the medical device to be contained within the distal-most portion together; and

an articulation sheath surrounding the outer tube in between the handle and the distal-most portion of the outer tube such that the outer tube is longitudinally moveable within the sheath, the sheath including a proximal end, located distal to the handle, a distal end, and a pull-wire member extending between the proximal and distal ends of the sheath, the pull-wire member including a proximal control end and a distal end, the distal end being anchored in proximity to the distal end of the sheath for deflection thereof, and the sheath having an inner diameter that is smaller than an outer diameter of the distal-most portion of the outer tube and an outer diameter of the handle;

wherein, when the distal end of the inner member is engaged within the distal-most portion of the outer tube, longitudinal movement of the outer tube, in a distal direction, relative to the articulation sheath, causes similar longitudinal movement of the inner member; and

when the outer tube is moved longitudinally in a proximal direction, relative to the handle, the distal end of the inner member is disengaged within the distal-most portion of the outer tube so that the movement of the outer tube is independent of the inner member.

2. The assembly of claim 1, wherein the length of the articulation sheath is between approximately 85 cm and approximately 95 cm.

3. The assembly of claim 1, wherein a maximum distance between the handle and the distal end of the outer tube is between approximately 95 cm and approximately 110 cm.

4. The assembly of claim 1, wherein, when the distal end of the articulation sheath is located within approximately 1 cm from the distal-most portion of the outer tube, the proximal end of the articulation sheath is located at a distance of approximately 10 cm distal to the handle

5. The assembly of claim 1, wherein a maximum travel for the one of the at least one control member along the handle moves the outer tube in the proximal direction over a distance of approximately 10 cm.

6. The assembly of claim 1, wherein the articulation sheath comprises a braid structure sandwiched between an inner polymer liner and a polymer outer jacket, the polymer outer jacket being divided into a proximal segment and a distal segment, the distal segment having a lower durometer than the proximal segment and extending over a length of approximately 3 cm.

7. The assembly of claim 1, wherein the inner member further includes a pull-wire extending between the proximal and distal ends thereof, a proximal end of the pull-wire of the inner member being coupled to another of the at least one control member and a distal end of the pull-wire being anchored in close proximity to the distal end thereof.

8. The assembly of claim 1, wherein:

the outer tube further includes an internal shoulder defining a proximal end of the distal-most portion of the outer tube; and

the distal end of the inner member engages within the lumen of the outer tube by abutting the internal shoulder.

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

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

a handle including at least one control member;

an elongate outer tube extending distally from the handle and 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 outer tube, the proximal end of the outer tube being coupled to one of the at least one control member of the handle, the outer tube being longitudinally moveable relative to the handle, via the control member, and the outer tube including a distal-most portion having a length along which the lumen is sized to contain an entirety of the medical device therein, the distal opening of the lumen allowing passage of the medical device therethrough for the deployment;

an elongate inner member extending within the lumen of the outer tube and forming an inner lumen that extends from a proximal opening thereof at a proximal end of the inner member to a distal opening thereof at a distal end of the inner member, the distal end of the inner member being configured to conform to a proximal end of the implantable medical device and to engage within the distal-most portion of the outer tube at a location that allows the engaged distal end of the inner member and the entirety of the medical device to be contained within the distal-most portion together;

an articulation sheath surrounding the outer tube in between the handle and the distal-most portion of the outer tube such that the outer tube is longitudinally moveable within the sheath, the sheath including a proximal end, located distal to the handle, and a distal segment having a pre-formed curvature, and the sheath having an inner diameter that is smaller than an outer diameter of the distal-most portion of the outer tube and an outer diameter of the handle; and

a straightening mandrel configured to slide within the inner lumen of the inner member and having a length sufficient to straighten the pre-formed curvature of the distal segment of the articulation sheath when the mandrel is fully inserted within the inner lumen of the inner member;

wherein, when the distal end of the inner member is engaged within the distal-most portion of the outer tube, the longitudinal movement of the outer tube, in a distal direction, relative to the articulation sheath, causes similar longitudinal movement of the inner member; and

when the outer tube is moved longitudinally in a proximal direction, relative to the handle, the distal end of the inner member is disengaged within the distal-most portion of the outer tube so that the movement of the outer tube is independent of the inner member.

11. The assembly of claim 10, wherein the length of the articulation sheath is between approximately 85 cm and approximately 95 cm.

12. The assembly of claim 10, wherein a maximum distance between the handle and the distal end of the outer tube, when the outer tube is in the proximal position, is between approximately 95 cm and approximately 110 cm.

13. The assembly of claim 10, wherein a maximum travel for the one of the at least one control member along the handle moves the outer tube in the proximal direction over a distance of approximately 10 cm.

14. The assembly of claim 10, wherein the articulation sheath comprises a braid structure sandwiched between an inner polymer liner and a polymer outer jacket, the polymer outer jacket being divided into a proximal segment and a distal segment, the distal segment having a lower durometer than the proximal segment and extending over a length of approximately 3 cm.

15. The assembly of claim 10, wherein the inner member further includes a pull-wire extending between the proximal and distal ends thereof, a proximal end of the pull-wire of the inner member being coupled to another of the at least one control member and a distal end of the pull-wire being anchored in close proximity to the distal end thereof.

16. The assembly of claim 10, wherein:

the outer tube further includes an internal shoulder defining a proximal end of the distal-most portion of the outer tube; and

the distal end of the inner member engages within the lumen of the outer tube by abutting the internal shoulder.

17. The assembly of claim 10, wherein the distal end of the inner member is radiopaque.

18. 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.

19. The method of claim 18, 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.

20. The method of claim 19, 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.

21. The method of claim 18, 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.

22. The method of claim 21, wherein releasing the distal segment comprises withdrawing a straightening mandrel from a position within a lumen of the inner member.

23. The method of claim 18, 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.

24. The method of claim 18, 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.

25. The method of claim 18, 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.