Polymer scaffold sheaths

• US 8,414,528 B2
• Filed: 05/27/2011
• Issued: 04/09/2013
• Est. Priority Date: 05/27/2011
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Liu, Annie P., Phillips, Jason, Johnson, Mark C., McNiven, Sean
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US13/118,311
• Publication Number:
  US 20120302955A1
• Time in Patent Office: 683 Days
• Field of Search: 604/103.05, 604/160, 604/161, 623/1.11, 623/1.12
• US Class Current: 604/103.05
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1036 Making parts for balloon catheter systems, e.g. shafts or distal ends A61M25/1029 takes precedence
• CPC Class Codes: Y10T 29/49865 by temperature differential [e.g., shrink fit]
• CPC Class Codes: Y10T 29/49913 by constricting outer annulus

Abstract

A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath pair is placed over the crimped scaffold after crimping to reduce recoil of the crimped polymer scaffold and maintain scaffold-balloon engagement relied on to hold the scaffold to the balloon when the scaffold is being delivered to a target in a body. The sheath pair is removed by a health professional before placing the scaffold within the body.

Claims

1. An apparatus, comprising:

a catheter assembly having a distal end and including a scaffold comprising a polymer crimped to a balloon, the scaffold having a length;

a protecting sheath disposed over the scaffold, extending distally of the distal end, and having a total length that is a sum of a first length and a second length, wherein the first length is about the scaffold length, the second length is equal to or greater than the first length, and the second length is about equal to an amount that the protecting sheath extends distally of the distal end; and

a constraining sheath disposed over the protecting sheath and the scaffold to limit recoil of the scaffold by applying an inwardly directed radial force on the scaffold;

wherein the apparatus is configured for being passed through a body only after the constraining and protecting sheaths are removed.

2. The apparatus of claim 1, wherein the protecting sheath includes a first and second separable half forming a proximal portion of the protecting sheath.

3. The apparatus of claim 1, wherein the protecting sheath includes a first protecting sheath portion and a second protecting sheath portion spanning the first length and the second length, respectively,

wherein the first protecting sheath portion comprises a cut forming halves of the protecting sheath, and

wherein the second protecting sheath portion is substantially devoid of the cut.

4. The apparatus of claim 3, wherein the second protecting sheath portion includes a raised portion located distally and proximally of the first protecting sheath portion.

5. An apparatus, comprising:

a catheter assembly having a distal end and including a scaffold comprising a polymer crimped to a balloon, the scaffold having a length;

a sheath disposed over the scaffold and extending distally of the catheter distal end by about a length equal to the scaffold length;

the sheath including a protecting sheath disposed over the scaffold and a constraining sheath disposed over the protecting sheath and the scaffold to limit recoil of the scaffold by applying an inwardly directed radial force on the scaffold, wherein the protecting sheath includes an abutment having an extent capable of preventing the constraining sheath from being disposed proximally of a proximal end of the scaffold and balloon; and

wherein the apparatus is configured for being passed through a body only after the constraining and protecting sheaths are removed.

6. The apparatus of claim 5, wherein the abutment comprises a crimped portion of the protecting sheath.

7. An apparatus, comprising:

a scaffold crimped to a balloon of a catheter, the catheter having a distal end and the scaffold being crimped to the balloon proximally of the distal end;

a first sheath disposed over the scaffold, the first sheath including an extension that is disposed distally of the catheter distal end; and

a second sheath disposed over the scaffold;

wherein the first sheath and second sheath are arranged relative to each other such that the apparatus is capable of being configured into a medical device suitable for being introduced into a patient by (a) pulling the second sheath distally along the first sheath outer surface such that the second sheath is displaced to a location substantially distal of the scaffold or the catheter distal end, and (b) after the first sheath has been moved to the substantially distal location, removing the first sheath from the scaffold by pulling the second sheath against the first sheath extension, thereby displacing the first sheath distally with the second sheath.

8. The apparatus of claim 7, the catheter having a shaft and the shaft having a lumen, further including

a mandrel disposed within the shaft lumen;

wherein the mandrel, first sheath and second sheath are arranged relative to each other such that the apparatus is capable of being configured into a medical device suitable for being introduced into a patient by simultaneously removing the mandrel from the lumen and the first sheath from the scaffold by pulling the second sheath against the first sheath extension while gripping the mandrel, thereby displacing the first sheath distally with the second sheath and removing the mandrel from the catheter shaft lumen.

9. The apparatus of claim 7, wherein the first sheath extension has a length about equal to the length of the second sheath.

10. The apparatus of claim 9, wherein the first sheath extension includes an abutment preventing removal of the second sheath from the first sheath extension when the second sheath is displaced to the location substantially distal of the scaffold or the catheter distal end.

11. An apparatus, comprising:

a scaffold crimped to a balloon of a catheter, the catheter having a distal end and the scaffold being crimped to the balloon proximally of the distal end;

a first sheath disposed over the scaffold, the first sheath including a distal extension disposed distally of the catheter distal end and a notched portion disposed proximally of the scaffold; and

a second sheath disposed over the scaffold and first sheath, the second sheath applying a preload to the scaffold and the first sheath to maintain contact between the first sheath and scaffold;

wherein the first sheath is removable from the scaffold only after the second sheath has been moved to the distal extension such that the notched portion is capable of deflecting away from the scaffold only when the second sheath is removed from the scaffold; and

wherein the apparatus is configured as a medical device suitable for being introduced into a patient when the first and second sheaths are removed from the catheter.

12. The apparatus of claim 11, wherein the first sheath includes an upper and lower half which together form the notched portion.

13. The apparatus of claim 12, wherein the first sheath includes a raised portion disposed proximally of the notched portion.

14. An apparatus, comprising:

a catheter assembly having a distal end and including a scaffold comprising a polymer crimped to a balloon, the scaffold having a length;

a sheath disposed over the scaffold and applying a radial inward force on the scaffold to limit recoil of the scaffold;

the sheath comprises a protecting sheath and a constraining sheath disposed on the protecting sheath, wherein the sheath extends distally of the catheter distal end by about a length equal to the length of the scaffold; and

the protecting sheath includes a first and second separable half forming a proximal portion of the protecting sheath, wherein the first and second separable halves terminate at about the catheter distal end or a scaffold distal end and form a living hinge, and wherein the first and second separable halves separate from each other when the constraining sheath is disposed on the protecting sheath and substantially distal of the living hinge;

wherein the apparatus is configured for being passed through a body only after the constraining and protecting sheaths are removed.

15. The apparatus of claim 14, wherein the protecting sheath is at least twice the length of the constraining sheath.

16. The apparatus of claim 14, wherein the protecting sheath extends distally of the distal end by at least the scaffold length.

17. The apparatus of claim 16, wherein the protecting sheath extends distally of the distal end by more than the scaffold length.

18. The apparatus of claim 14, wherein the protecting sheath includes an interfering ledge preventing removal of the protecting sheath when the constraining sheath is disposed over the scaffold.

19. The apparatus of claim 18, wherein a first and second portion of the interfering ledge are separated from each other by a radial force applied by the constraining sheath on the protecting sheath when the constraining sheath is substantially distal of the living hinge.