Sheaths used with polymer scaffold

• US 8,852,257 B2
• Filed: 06/21/2011
• Issued: 10/07/2014
• Est. Priority Date: 06/21/2011
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Liu, Annie P., Phillips, Jason, Johnson, Mark C., Lord, Brenna Hearn, Beer, Jeremy, Yribarren, Travis, Saville, Steve, Speck, Marc L.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): DANG, ANH TIEU
• Application Number:
  US13/165,662
• Publication Number:
  US 20120324696A1
• Time in Patent Office: 1,204 Days
• Field of Search: 623/1.11, 623/1.12, 606/108, 606/200, 604/103.05, 604/160, 604/161
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or 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: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 29/49863 with prestressing of part

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 balloon catheter having a distal end and including a scaffold comprising a polymer crimped to a balloon of the catheter;

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

a protecting portion having a distal end,

a constraining portion having a distal end and being disposed over the protecting portion, wherein the constraining portion distal end is distal of the catheter distal end and the protecting portion distal end, and

a connector portion connecting the protecting portion and constraining portion,

wherein the protecting portion, constraining portion and connector portion comprise a unitary piece of flexible polymer material,

wherein the connector portion is deformed into, or shaped as a loop having one end at the constraining portion and the other end at the protecting portion such that the distal end of the protecting portion may be received within a proximal end of the constraining portion, and

wherein the apparatus is configured for being passed through the body of a patient only after the sheath is removed.

2. The apparatus of claim 1, wherein the constraining and protecting portions are configured so that the sheath is capable of being removed from the scaffold by the following steps:

pulling an extension of the constraining portion distally to withdraw only the constraining portion from the scaffold and protecting portion,

after the constraining portion has been displaced distally, continuing to pull the constraining portion distally to remove both the constraining portion and the protecting portion from the scaffold.

3. The apparatus of claim 1, wherein the protecting portion includes a first and second portion disposed over at least a substantial portion of the scaffold, the first and second portions configured for deflecting radially away from the scaffold when the constraining portion is removed from the scaffold.

4. The apparatus of claim 3, wherein the first portion is connected to a proximal end of the constraining portion.

5. The apparatus of claim 1, wherein the constraining portion includes a stepped down section.

6. An apparatus, comprising:

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

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

a protecting portion having a distal end,

a constraining portion disposed over the protecting portion, the constraining portion including a stepped down section and a distal end that is distal of the catheter distal end and the protecting portion distal end, and

a connector portion connecting the protecting portion and constraining portion,

wherein the protecting portion, constraining portion and connector portion comprise a unitary piece of flexible polymer material,

wherein the connector portion is deformed into, or shaped as a loop having one end at the constraining portion and the other end at the protecting portion such that the distal end of the protecting portion may be received within a proximal end of the constraining portion, and

wherein the apparatus is configured for being passed through the body of a patient only after the sheath is removed by pulling the constraining portion away from the catheter distal end.