Scaffold Loading and Delivery Systems

• US 20170189215A1
• Filed: 12/13/2016
• Published: 07/06/2017
• Est. Priority Date: 12/30/2015
• Status: Active Grant

• Current Assignee: Lyra Therapeutics, Inc.
• Original Assignee: Lyra Therapeutics, Inc.
• Inventors: Core, Lee, Merlo, Jon, Prahl, Garrett, White, Travis, Goh, Bryan, Beyreis, Randy
• Granted Patent: US 10,973,664 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

This disclosure pertains, inter alia, to scaffold loading and delivery devices, assemblies, systems and methods of using the same.

Claims

1. A loading assembly comprising:

(a) a funnel assembly comprising a tapered funnel structure having a distal end and a proximal end and comprising (i) a loading lumen having a loading axis, an open distal end, an open proximal end, and at least one tapered region having a distal end with a first diameter and a proximal end with a second diameter that is smaller than the first diameter and (ii) a slotted wall surrounding the loading lumen that has a plurality of longitudinal slots formed therein, the slots having an open distal end; and

(b) a loading aid assembly comprising (i) a receptacle comprising a receptacle wall, a receptacle lumen having a least one open receptacle lumen end and a receptacle axis, (ii) a scaffold comprising a scaffold wall and having a scaffold axis, a proximal scaffold end, a distal scaffold end, an inner luminal surface and an outer abluminal surface, (iii) a plurality of loading pins comprising loading pin shafts that extend from the receptacle wall, into the receptacle lumen and through the scaffold wall, said pins holding said scaffold within the receptacle lumen in a position wherein the scaffold axis is coaxial with the receptacle axis,

wherein the loading aid assembly is configured to receive the distal end of the tapered funnel structure within the receptacle lumen via the open receptacle lumen end, such that the scaffold is at least partially positioned in the loading lumen, such that at least a portion of the tapered funnel structure wall is positioned between the outer abluminal surface of the stent and the inner luminal surface of the receptacle wall, such that the loading pins are positioned within the longitudinal slots of the tapered funnel structure, and such that longitudinal movement of the loading aid assembly in a proximal direction relative to the funnel assembly results in proximal longitudinal movement of the loading pins within the slots of the tapered funnel structure and proximal longitudinal movement of at least the proximal scaffold end into the tapered region reducing at least a portion of the diameter of the scaffold.

2. The loading assembly of claim 1, wherein loading pins comprises a loading pin shaft that extends through an aperture in the receptacle wall and into the receptacle lumen and an enlarged portion positioned on a side of the receptacle wall opposite the receptacle lumen, the enlarged portion having a width that is greater than a width of the aperture.

3. The loading assembly of claim 1, wherein the loading aid assembly further comprises springs that bias the loading pins toward the receptacle axis.

4. The loading assembly of claim 1, wherein the receptacle comprises first and second walls separated by a gap and wherein the enlarged portions of the pins are positioned in the gap between the walls.

5. The loading assembly of claim 1, comprising a stop that limits the proximal longitudinal movement of the loading pin shafts within the slots of the tapered funnel structure.

6. The loading assembly of claim 5, wherein removal of the loading pin shafts from the scaffold wall and the slots allows additional longitudinal movement of the loading aid assembly in a proximal direction relative to the funnel assembly, and wherein the receptacle is configured to compress and close the slots of the tapered funnel structure upon said additional longitudinal movement.

7. The loading assembly of claim 6, comprising a pin lift having a radially tapered surface, such that relative longitudinal movement between the radially tapered surface of the pin lift and the loading pins engages the loading pins and moves the loading pins radially away from the receptacle axis.

8. The loading assembly of claim 7, wherein the pin lift is part of the funnel assembly and wherein distal longitudinal movement of the radially tapered surface of the pin lift relative to the loading pins engages the loading pins and moves the loading pins radially away from the receptacle axis.

9. The loading assembly of claim 7, wherein the loading pins comprise a loading pin shaft that extends through an aperture in the receptacle wall and into the receptacle lumen and an enlarged portion positioned on a side of the receptacle wall opposite the receptacle lumen and having a width that is greater than a width of the aperture, and wherein the distal longitudinal movement of the pin lift relative to the loading pins causes the tapered surface of the pin lift to engage the enlarged portions of the loading pins and move the loading pins radially away from the receptacle axis.

10. The loading assembly of claim 9, wherein the pin lift comprises a plurality of tapered projections each pair forming a slot therebetween which is configured to receive the loading pin shafts.

11. The loading assembly of claim 8, wherein the receptacle comprises first and second walls separated by a gap and wherein the pin lift and the receptacle are configured such that the receptacle receives the distal end of the pin lift within the gap.

12. The loading assembly of claim 1, wherein the funnel assembly further comprises a clamp for positioning a delivery sheath of a catheter in a position such that the delivery sheath is positioned to receive the scaffold from the loading lumen.

13. A loading system comprising the loading assembly of claim 1 and a catheter that comprises:

(a) an outer sheath comprising an outer sheath lumen and having a proximal outer sheath end and a distal outer sheath end and (b) an inner member having an inner member proximal end and an inner member distal end and comprising an elongate shaft and an enlarged diameter portion near the inner member distal end, at least a portion of said elongate inner member being disposed within the outer sheath.

14. The loading system of claim 13, wherein the outer sheath and the inner member are positioned relative to the tapered funnel structure such that the distal end of the outer sheath lumen is in communication with the loading lumen and such that the elongate inner member extends beyond the distal end of the outer sheath and at least partially though the tapered region of the loading lumen.

15. The loading system of claim 14, wherein proximal longitudinal movement of the loading aid assembly relative to the funnel assembly to a point where the loading pins reach a stop results a reduction in diameter of at least a proximal portion of the scaffold and results in the scaffold being disposed around the enlarged diameter portion of the inner elongate member.

16. The loading system of claim 15, wherein removal of the loading pin shafts from the slots and further proximal longitudinal movement of the loading aid assembly beyond the point where the loading pins reach a stop causes compression of the tapered funnel structure such that the slots close, such that the inner diameter of the tapered region is reduced, and such that proximal movement of the inner elongate member causes the enlarged diameter portion of the inner elongate member to engage the scaffold and draw the scaffold into outer sheath.

17. The loading system of claim 16, wherein an inner luminal surface of the receptacle wall is tapered such that the slots close and the diameter of the tapered region is reduced upon said further proximal longitudinal movement of the loading aid assembly.

18. The loading system of claim 16 comprising a handle that independently proximally retracts the inner elongate member and outer sheath.

22. A method of crimping a tubular self-expanding scaffold using the loading assembly of claim 1, the method comprising:

joining said loading aid assembly with said funnel assembly such that the distal end of the tapered funnel structure is positioned within the receptacle lumen, such that the scaffold is at least partially positioned in the loading lumen, such that at least a portion of the tapered funnel structure wall is positioned between the outer abluminal surface of the stent and the inner luminal surface of the receptacle wall, and such that the loading pins are positioned within the longitudinal slots of the tapered funnel structure; and

generating longitudinal movement of the loading aid assembly in a proximal direction relative to the funnel assembly such that the loading pins undergo proximal longitudinal movement within the slots of the tapered funnel structure and such that at least the proximal scaffold end undergoes proximal longitudinal movement into the tapered region, thereby reducing at least a portion of the diameter of the scaffold.

23. The method of claim 22, further comprising removing the loading pin shafts from the scaffold wall and the slots.

24. The method of claim 23, further comprising generating further longitudinal movement of the loading aid assembly in a proximal direction relative to the funnel assembly and wherein an inner luminal surface of the receptacle wall is tapered such that the receptacle compresses and closes the slots of the tapered funnel structure as a result of the further longitudinal movement.

25. The method of claim 22, wherein the funnel assembly is attached to a delivery sheath of a catheter such that the delivery sheath is positioned to receive the scaffold from the loading lumen.

26. The method of claim 22,

wherein the funnel assembly is attached to a catheter that comprises (a) an outer sheath comprising an outer sheath lumen and having a proximal outer sheath end and a distal outer sheath end and (b) an inner member having an inner member proximal end and an inner member distal end and comprising an elongate shaft and an enlarged diameter portion near the inner member distal end, at least a portion of said elongate inner member being disposed within the outer sheath,

wherein the outer sheath and the inner member are positioned relative to the tapered funnel structure such that the distal end of the outer sheath lumen is in communication with the loading lumen and such that the elongate inner member extends beyond the distal end of the outer sheath and at least partially though the tapered region of the loading lumen, and

wherein the longitudinal movement of the loading aid assembly in a proximal direction relative to the funnel assembly causes the scaffold to be disposed around the enlarged diameter portion of the inner elongate member and reduces at least a portion of the diameter of the scaffold that is disposed around the enlarged diameter portion of the inner elongate member into engagement with the enlarged diameter portion of the inner elongate member.

27. The method of claim 26, further comprising proximally moving the inner elongate member relative to the outer sheath, thereby drawing the scaffold into the outer sheath lumen.

19. A catheter that comprises:

(a) an outer sheath comprising an outer sheath lumen and having a proximal outer sheath end and a distal outer sheath end and (b) an inner member having an inner member proximal end and an inner member distal end and comprising an elongate shaft and an enlarged diameter portion near the inner member distal end that comprises a hub and a plurality of radial projections extending from the hub, said inner member being disposable within the outer sheath.

20. The catheter of claim 19, wherein the inner member further comprises a braid reinforced tube, a wound wire coil and a tapered distal tip.

21. The catheter of claim 19, wherein the outer sheath comprises a proximal shaft and an outer distal capsule.