DELIVERY SYSTEM ASSEMBLIES FOR IMPLANTABLE MEDICAL DEVICES

• US 20130131693A1
• 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., Allan, James C.
• Granted Patent: US 9,216,293 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 2560/066 catheters therefor
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• 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

Abstract

An inner subassembly of a delivery system assembly extends within a lumen of an elongate outer tube of the assembly, and includes a flared distal end, which is preferably configured to conform to a proximal end of an implantable medical device; a distal-most portion of the outer tube is sized to contain both the flared distal end and an entirety of the medical device. The inner subassembly includes a core, an elongate pull-wire, extending along the core, and a sheath surrounding the pull-wire and the core; the sheath includes a slot opening that allows the pull-wire to pass laterally therethrough. The assembly preferably has a pre-formed curvature along a length of the sheath, and the slot opening extends along the pre-formed curvature. The outer tube is longitudinally moveable relative to the inner subassembly, for example, to deploy the medical device.

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 core extending from a proximal end thereof to a flared distal end thereof, the proximal end being fixed within the handle, and the flared distal end being configured to conform to a proximal end of the medical device;

an elongate outer tube forming a lumen in which the core extends, the outer tube including a proximal end, a distal end and a distal-most portion extending proximally from the distal end of the outer tube, the lumen having a proximal opening at the proximal end of the outer tube and a distal opening at the distal end of the outer tube, the proximal end of the outer tube being coupled to the first control member of the handle, the outer tube being longitudinally moveable, with respect to the handle and the core, between first and second positions, by means of the first control member, the flared distal end of the core being located within the distal-most portion, when the outer tube is in the first position, and the lumen of the outer tube, along a length of the distal-most portion, being sized to contain both the flared distal end of the core and an entirety of the medical device, together, within the distal-most portion, when the outer tube is in the first position;

an elongate pull-wire extending along the core and within the lumen of the outer tube, the pull-wire including a proximal end and a distal end, the proximal end of the pull-wire being coupled to the second control member of the handle and the distal end of the pull-wire being anchored to the core in close proximity to the flared distal end thereof; and

a sheath extending around the pull-wire and the core and within the lumen of the outer tube, the sheath including a distal end, a proximal end and a slot opening located therebetween, the distal end of the sheath being coupled to the core in close proximity to the anchored distal end of the pull-wire, the proximal end of the sheath being located within the lumen of the outer tube and spaced apart, distally, from the handle, and the slot opening being located and sized to allow the pull-wire to pass laterally therethrough;

wherein, when the outer tube is in the second position, the flared distal end of the core is located in proximity to the distal end of the outer tube.

2. The assembly of claim 1, wherein a length of the slot opening of the sheath is between approximately 2.5 cm and approximately 3 cm.

3. The assembly of claim 1, wherein the sheath has a length of between approximately 12 cm and approximately 18 cm, and the proximal end of the sheath is spaced distally apart from the handle by a longitudinal distance of between approximately 90 cm and approximately 100 cm.

4. The assembly of claim 1, wherein the elongate core is formed from a braid reinforced polymer comprising a polyether block amide and a polyamide;

and the sheath is formed from a polyether block amide having a hardness in a range of approximately 50 to approximately 55 on a shore D scale.

5. The assembly of claim 1, wherein the assembly has a pre-formed curvature along a length of the sheath, the curvature extending about a radius of between approximately 9 cm and approximately 13 cm, and the slot opening of the sheath extending along a length of the curvature.

6. The assembly of claim 1, wherein the flared distal end of the core is radiopaque.

7. The assembly of claim 1, wherein a longitudinal distance between the handle and the distal end of the outer tube, when the outer tube is in the first position, is between approximately 103 cm and approximately 107 cm.

8. The assembly of claim 1, wherein a longitudinal distance between the first position and the second position of the outer tube ranges from approximately 2 cm to approximately 6 cm.

9. The assembly of claim 1, further comprising a valve interface 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.

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

an elongate outer tube extending from a proximal end thereof to a distal-most portion thereof, the outer tube forming a lumen that extends from a proximal opening thereof at the proximal end of the outer tube to a distal opening thereof that terminates the distal-most portion of the outer tube, the distal-most portion being sized to contain an entirety of the implantable medical device therein;

an inner subassembly extending within the lumen formed by the outer tube, the inner subassembly including an elongate core, a pull-wire and a sheath that extends around the pull-wire and the core, the core including a proximal end, positioned proximal to the proximal end of the outer tube, and a flared distal end being configured to conform to a proximal end of the medical device such that the distal end of the core fits, along with the entirety of the medical device, within the distal-most portion of the outer tube, the pull-wire extending along the core and including a distal end anchored to the core in close proximity to the flared distal end thereof, and the sheath extending from a proximal end thereof to a distal end thereof, the proximal end of the sheath being spaced apart, distally, from the proximal end of the outer tube, and the distal end coupled to the core in close proximity to the anchored distal end of the pull-wire, the sheath including a slot opening formed therein, and the slot opening being sized to allow the pull-wire to pass laterally therethrough;

wherein the assembly has a pre-formed curvature, along a length of the sheath, and the slot opening of the sheath extends along the pre-formed curvature; and

the outer tube is longitudinally moveable relative to the inner subassembly.

11. The assembly of claim 10, wherein the pre-formed curvature extends about a radius of between approximately 9 cm and approximately 13 cm, and the distal-most portion of the outer tube is oriented, by the curvature, at an angle of approximately 120 degrees with respect to a length of the assembly that extends proximal to the pre-formed curvature.

12. The assembly of claim 10, wherein a length of the slot opening of the sheath of the inner subassembly is between approximately 2.5 cm and approximately 3 cm.

13. The assembly of claim 10, wherein the sheath of the inner subassembly has a length of between approximately 12 cm and approximately 18 cm, and the proximal end of the sheath is spaced distally apart from the proximal end of the outer tube by a longitudinal distance of between approximately 90 cm and approximately 100 cm.

14. The assembly of claim 10, wherein the elongate core of the inner subassembly is formed from a braid reinforced polymer comprising a polyether block amide and a polyamide;

and the sheath is formed from a polyether block amide having a hardness in a range of approximately 50 to approximately 55 on a shore D scale.

15. The assembly of claim 10, wherein the flared distal end of the core of the inner subassembly is radiopaque.