SCAFFOLD LOADING AND DELIVERY SYSTEMS

• US 20170000634A1
• Filed: 06/29/2016
• Published: 01/05/2017
• Est. Priority Date: 06/29/2015
• Status: Active Grant

• Current Assignee: Lyra Therapeutics, Inc.
• Original Assignee: Lyra Therapeutics, Inc.
• Inventors: Helmick, Marc, Merlo, Jonathan, Pham, Quyhn, Prostrollo, Anthony, Paulson, Ross, Peterson, Danielle, Roggemann, Michele, Core, Lee, Prahl, Garrett, Beyreis, Randall
• Granted Patent: US 10,159,586 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/186 Nose parts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 describes, inter alia, materials, devices, kits and methods that may be used for loading scaffolds into delivery devices and delivery of scaffolds into the body of a patient, including delivery of scaffolds to the sinuses for the treatment of chronic sinusitis, among other purposes.

Claims

1. A delivery system comprising, (a) a first assembly comprising (i) a loading member that comprises a tapered loading lumen having a proximal loading lumen end and a distal loading lumen end, wherein the proximal loading lumen end has a first diameter and the distal loading lumen end has a second diameter that is smaller than the first diameter and (ii) a delivery sheath having a delivery sheath lumen that is connected to the loading lumen, and (b) a second assembly comprising (i) a self-expanding scaffold, said scaffold comprising a scaffold wall and having a scaffold lumen, a proximal scaffold end, a distal scaffold end, an inner luminal surface, and an outer abluminal surface, (ii) an elongate advancement member having a proximal end and a distal end, (iii) at least one filament linking an end of the elongate advancement member to the scaffold, and (iv) an elongate inner member having a proximal end and a distal end, wherein the elongate advancement member and elongate inner member may be the same or different, wherein the second assembly is configured to be inserted into the proximal loading lumen end of the loading member and advanced at least partially through the first assembly, such that the scaffold is moved through the loading lumen in a proximal-to-distal direction.

2. The delivery system of claim 1, wherein the first assembly further comprises a handle.

3. The delivery system of claim 2, wherein the loading member is in the form of a funnel and wherein either the funnel is detachable from the handle or wherein the funnel and handle are integrated into a single article.

4. The delivery system of claim 1, wherein the elongate inner member and the elongate advancement member are different, wherein the elongate advancement member is positioned distal to the elongate inner member, wherein at least one filament links the scaffold to the elongate advancement member.

5. The delivery system of claim 4, wherein the second assembly is configured to be advanced at least partially through the first assembly by applying force to either end of the elongate advancement member.

6. The delivery system of claim 5, wherein (a) the distal end of the elongate inner member is configured to engage the proximal end of the elongate advancement member or (b) the elongate inner member is hollow and has a lumen, and wherein the second assembly further comprises additional elongate member having a proximal end and a distal end that is configured to extend through the lumen of the inner elongate member and engage the proximal end of the elongate advancement member.

7. The delivery system of claim 6, wherein a receptacle is provided at a proximal end of the elongate advancement member that is configured to receive the distal end of the elongate inner member or to receive the distal end of the additional elongate member.

8. The delivery system of claim 5, wherein at least one filament is looped from the elongate advancement member, through at least one aperture in the scaffold wall, and back to the elongate advancement member.

9. The delivery system of claim 8, wherein both ends of the at least one filament are attached to the elongate advancement member.

10. The delivery system of claim 9, wherein the elongate advancement member comprises a groove and wherein one end of the at least one filament is positioned in the groove so that the one end can be cut and severed from the elongate advancement member.

11. The delivery system of claim 8, wherein the elongate advancement member comprises two portions that are configured to be reversibly joined.

12. The delivery system of claim 11, wherein the two portions are joined together, wherein one end of the at least one filament is attached to one of the two portions, and wherein an opposite end of the at least one filament is trapped between the two portions.

13. A delivery system comprising (a) an elongate inner member, (b) a loading member that comprises a loading lumen having a loading lumen axis and a plurality of longitudinal pathways adjacent to the loading lumen, said loading lumen comprising a tapered lumen region having a proximal tapered lumen end with a first diameter and a distal tapered lumen end with a second diameter that is smaller than the first diameter, (c) a self-expanding scaffold disposed around the elongate inner member within the loading lumen, said scaffold comprising a scaffold wall and having a scaffold lumen, a proximal scaffold end, a distal scaffold end, an inner luminal surface, an outer abluminal surface, (d) a plurality of loading pins configured for engagement with the scaffold wall and for longitudinal movement along the longitudinal pathways, such that longitudinal movement of the loading pins along the longitudinal pathways is accompanied by longitudinal movement of the scaffold, and (e) optionally, a delivery sheath comprising a delivery lumen in communication with the loading lumen, said delivery lumen having a delivery lumen diameter.

14. The delivery system of claim 13, wherein the longitudinal pathways comprise slots.

15. The delivery system of claim 13, wherein the plurality of loading pins extend through the scaffold wall and into the elongate inner member, and wherein the delivery system is configured such that the longitudinal movement of the loading pins along the longitudinal pathways results in longitudinal movement of the elongate inner member and the scaffold.

16. The delivery system of claim 15, wherein the plurality of loading pins extend through a first aperture in the scaffold wall, through the elongate inner member and through a second aperture in the scaffold wall opposite the first aperture the scaffold wall.

17. The delivery system of claim 13, further comprising a removable packaging feature that engages the loading pins and the loading member such that the loading pins are held in place within the loading member.

18. The delivery system of claim 13, wherein the delivery system comprises a loading pin engagement member that is configured to reversibly engage and distally advance the loading pins.

19. The delivery system of claim 18, wherein the loading pin engagement member is a ring-shaped member.

20. The delivery system of claim 13, wherein the loading pins are configured to be disengaged manually from the scaffold.

21. A delivery system comprising, (a) a loading member that comprises a loading lumen having a lumen axis and a luminal surface, a plurality of longitudinal pathways being formed in the luminal surface of the loading member adjacent to the loading lumen, said loading lumen comprising a tapered lumen region having a proximal tapered lumen end with a first diameter and a distal tapered lumen end with a second diameter that is smaller than the first diameter, (b) a self-expanding scaffold disposed within the loading lumen, said scaffold comprising a scaffold wall and having a scaffold lumen, a proximal scaffold end, a distal scaffold end, an inner luminal surface, an outer abluminal surface, (c) an engagement device comprising an engagement device axis and a plurality of elongate members, which taper radially outward from the engagement device axis, which have a shape memory that allows the elongate members to be radially compressed and to self-expand after upon removal of radial compression, and which terminate in an engagement feature, wherein the engagement device is at least partially positioned within the scaffold lumen and loading lumen such that each engagement feature extends through the scaffold wall and into one of the longitudinal pathways and such that longitudinal movement of the engagement device is accompanied by longitudinal movement of the scaffold within the loading lumen.

22. The delivery system of claim 21, wherein the longitudinal pathways comprise grooves.

23. The delivery system of claim 21, further comprising a delivery sheath comprising a delivery lumen in communication with the loading lumen, said delivery lumen having a delivery lumen diameter.

24. The delivery system of claim 23, further comprising an elongate inner member, wherein the elongate inner member and engagement device are configured such that elongate inner member engages and pushes the engagement device through the loading lumen and at least a portion of the delivery sheath.

25. The delivery system of claim 21, wherein the engagement device further comprises an elongate shaft and wherein the plurality of elongate members extend from and taper radially outward from an end of the elongate shaft.

26. The delivery system of claim 25, wherein the elongate shaft is an elongate tubular shaft having a proximal end, a distal end, and a tubular shaft lumen, and wherein the plurality of elongate members extend through at least a portion of the tubular shaft lumen and taper radially outward from the proximal end of the elongate tubular shaft.