Scaffold loading and delivery systems
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.
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 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.
7. The delivery system of claim 6 , wherein a receptacle is provided at the proximal end of the elongate advancement member that is configured to receive the distal end of the elongate inner member.
8. The delivery system of claim 5 , wherein said 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 said 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 said 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. The delivery system of claim 5 , wherein the elongate inner member is hollow and has a lumen, and wherein the second assembly further comprises an 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.