Stents and catheters having improved stent deployment

• US 10,226,370 B2
• Filed: 08/12/2016
• Issued: 03/12/2019
• Est. Priority Date: 09/10/2008
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Schneider, Lucas Tradd, Ladd, Bryan Matthew, Kusleika, Richard, Kravik, Richard, Vreeman, Sandra
• Primary Examiner(s): Prebilic, Paul B
• Application Number:
  US15/235,377
• Publication Number:
  US 20160361186A1
• Time in Patent Office: 942 Days
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0004 bioabsorbable

Abstract

An implant delivery system and method comprises an implant, for example, a stent, and a delivery catheter. The stent has a scaffold with a coating or a shell that retains the scaffold in a collapsed configuration. The coating or shell is made of a material that dissolves or biodegrades upon exposure to a dissolution or biodegradation media. The stent is used with an implant delivery system which has a catheter with a catheter, wherein the stent is mounted on the catheter shaft. The catheter shaft is configured to be withdrawn through the patient'"'"'s vessel when the scaffold is in its expanded configuration. Advantageously, the implant is thereby prevented from changing length during implant delivery and implant deployment.

Claims

1. An implant delivery system comprising:

a catheter shaft;

a stent mounted on the catheter shaft, the stent including a scaffold having a collapsed configuration and an expanded configuration;

a shell surrounding the scaffold, the shell being configured to retain the scaffold in the collapsed configuration, the shell comprising tubing into which the scaffold is inserted, the shell being formed of a material that dissolves upon exposure to a dissolution media, and the scaffold being expandable from the collapsed configuration to the expanded configuration through exposure of the shell to the dissolution media, wherein the shell comprises perforations configured to assist fracture of the shell upon expansion of the scaffold; and

a tubular sheath covering, and in contact with, the shell while the scaffold is in the collapsed configuration, the tubular sheath being movable to expose the shell and enable the scaffold to expand from the collapsed configuration to the expanded configuration after at least a portion of the shell dissolves upon exposure to the dissolution media.

2. The implant delivery system of claim 1, wherein the shell comprises at least one of preplaced slits or slots configured to assist fracture of the shell upon expansion of the scaffold.

3. The implant delivery system of claim 2, wherein the shell comprises the preplaced slits, and wherein at least one of the preplaced slits is a longitudinal slit.

4. The implant delivery system of claim 1, wherein the shell forms a smooth exterior surface over the scaffold.

5. The implant delivery system of claim 1, wherein the scaffold is self-expanding.

6. The implant delivery system of claim 5, wherein the scaffold is configured to self-expand to the expanded configuration as the shell dissolves.

7. The implant delivery system of claim 1, wherein the scaffold is balloon-expandable.

8. The implant delivery system of claim 7, further comprising a balloon interposed between the scaffold and the catheter shaft, wherein the balloon is configured to expand the scaffold to the expanded configuration as the shell dissolves.

9. The implant delivery system of claim 1, wherein the shell is configured to maintain the scaffold in the collapsed configuration, and wherein the scaffold has an unexpanded diameter and a fixed length in the collapsed configuration.

10. The implant delivery system of claim 1, wherein the tubular sheath is axially slidable relative to the stent.

11. The implant delivery system of claim 1, wherein the shell comprises one or more antirestenotic agents.

12. The implant delivery system of claim 1, wherein the shell comprises an anti-inflammatory agent.

13. The implant delivery system of claim 1, wherein the shell comprises an antiatheromatic agent.

14. The implant delivery system of claim 1, wherein the shell comprises an antioxidative agent.

15. The implant delivery system of claim 1, further comprising a sheath seal configured to prevent the dissolution media from contacting the shell until the tubular sheath is moved to expose the shell to the dissolution media.

16. An implant delivery system comprising:

a catheter shaft;

a stent mounted on the catheter shaft, the stent including a scaffold having a collapsed configuration and an expanded configuration;

a shell surrounding the scaffold, the shell being configured to retain the scaffold in the collapsed configuration, the shell comprising a film wrapped around the scaffold, the shell being formed of a material that dissolves upon exposure to a dissolution media, and the scaffold being expandable from the collapsed configuration to the expanded configuration through exposure of the shell to the dissolution media, wherein the shell comprises perforations configured to assist fracture of the shell upon expansion of the scaffold; and

a tubular sheath covering, and in contact with, the shell while the scaffold is in the collapsed configuration, the tubular sheath being movable to expose the shell and enable the scaffold to expand from the collapsed configuration to the expanded configuration after at least a portion of the shell dissolves upon exposure to the dissolution media.

17. The implant delivery system of claim 16, wherein the shell comprises at least one of preplaced slits or slots configured to assist fracture of the shell upon expansion of the scaffold.

18. The implant delivery system of claim 16, wherein the scaffold is self-expanding.

19. The implant delivery system of claim 16, wherein the scaffold is balloon-expandable.

20. The implant delivery system of claim 16, wherein the shell comprises at least one of:

an antirestenotic agent, an anti-inflammatory agent, an antiatheromatic agent, or an antioxidative agent.

21. The implant delivery system of claim 16, further comprising a sheath seal configured to prevent the dissolution media from contacting the shell until the tubular sheath is moved to expose the shell to the dissolution media.

22. An implant delivery system comprising:

a catheter shaft;

a stent mounted on the catheter shaft, the stent including a scaffold having a collapsed configuration and an expanded configuration;

a shell surrounding the scaffold, the shell being configured to retain the scaffold in the collapsed configuration, the shell comprising tubing into which the scaffold is inserted, the shell being formed of a material that dissolves upon exposure to a dissolution media, and the scaffold being expandable from the collapsed configuration to the expanded configuration through exposure of the shell to the dissolution media, wherein the shell comprises local thinning of a wall thickness that assists fracture of the shell upon expansion of the scaffold; and

a tubular sheath covering, and in contact with, the shell while the scaffold is in the collapsed configuration, the tubular sheath being movable to expose the shell and enable the scaffold to expand from the collapsed configuration to the expanded configuration after at least a portion of the shell dissolves upon exposure to the dissolution media.

23. The implant delivery system of claim 22, further comprising a sheath seal configured to prevent the dissolution media from contacting the shell until the tubular sheath is moved to expose the shell to the dissolution media.