Protective sheath assembly for a polymer scaffold

Abstract

A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath 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 is removed by a health professional either by removing the sheath directly or using a tube containing the catheter.

1 . An apparatus, comprising:
 a catheter comprising a scaffold crimped to a balloon of the catheter and a sheath comprising a protecting portion and a constraining portion disposed over the scaffold, wherein the protecting portion is located between the constraining portion and the scaffold;   a tube containing at least a portion of the catheter, the tube comprising a member disposed within the tube and configured to abut the constraining portion when the catheter is withdrawn from the tube, such that the member abutting the constraining portion displaces the constraining portion away from the scaffold as the catheter is withdrawn from the tube; and   wherein the catheter is configured for being introduced into a body only after the sheath is removed from the scaffold.   
     
     
         2 - 20 . (canceled) 
     
     
         21 . The apparatus of  claim 1 , wherein the member comprises a clip, rim or flange attached to the tube, or the member is a portion of the tube. 
     
     
         22 . The apparatus of  claim 1 , wherein
 the member is a clip attached to an exterior surface of the tube,   the clip comprises a protrusion that penetrates the bore of the tube, and   the constraining portion abuts the protrusion as the catheter is withdrawn from the tube.   
     
     
         23 . The apparatus of  claim 22 , wherein the clip includes
 two halves connected to each other by a living hinge, each half forming a protrusion received in respective through holes when the clip is attached to the exterior surface, and both protrusions penetrate the bore of the tube   
     
     
         24 . The apparatus of  claim 1 , wherein the member is a tube portion or a rim formed in the tube, wherein the constraining portion abuts the tube portion as the catheter is being withdrawn from the tube. 
     
     
         25 . The apparatus of  claim 1 , wherein the member is a neck of the tube, wherein the constraining portion abuts the neck as the catheter is withdrawn from the tube. 
     
     
         26 . The apparatus of  claim 25 , wherein the neck is located at a proximal end of the tube and adjacent a hub or handle portion of the catheter. 
     
     
         27 . The apparatus of  claim 1 , wherein the sheath is a one-piece sheath or a two-piece sheath. 
     
     
         28 . The apparatus of  claim 1 , wherein
 the tube is a two-piece tube comprising a first tube configured to contain the scaffold and the sheath therein, and   a second tube configured for mating with the first tube and comprising the member.   
     
     
         29 . An apparatus, comprising:
 a catheter comprising a scaffold crimped to a balloon of the catheter, and a sheath comprising a protecting portion and a constraining portion disposed over the scaffold, wherein the protecting portion is located between the constraining portion and the scaffold;   a tube containing a substantial portion of the catheter and comprising means for removing the constraining portion from the scaffold when the catheter is removed from the tube;   wherein the catheter is configured for being introduced into a body only after the sheath is removed from the scaffold.   
     
     
         30 . The apparatus of  claim 29 , wherein a proximal end of the tube is adjacent a hub or handle portion of the catheter. 
     
     
         31 . An apparatus, comprising:
 a catheter and a scaffold crimped to a balloon of the catheter;   a sheath covering the scaffold and configured for being removed therefrom before the catheter is introduced into a body;   a tube containing the catheter within a lumen defined by a first tube portion and a second tube portion attached to the first tube portion;   the first tube portion comprising a first clearance and a second clearance portions of walls of the first tube portion lumen, wherein a length of the second clearance is less than a length of the first clearance;   the scaffold and the sheath is contained in the second tube portion; and   the sheath is configured for being removed from the tube by the second clearance interfering with the sheath as the catheter is removed from the tube.   
     
     
         32 . The apparatus of  claim 31 , wherein the second clearance portion is located at an end of the first tube portion and the apparatus is configured such that the catheter is removed from the end of the first tube portion, thereby causing removal of the sheath from the catheter when the catheter is removed from the end of the first tube portion. 
     
     
         33 . The apparatus of  claim 31 , wherein
 the catheter comprises a hub or handle portion, and   the first tube portion has a first end and a second end, wherein
 the first end is adjacent the catheter hub or handle portion, 
 the first end comprises the second diameter clearance portion, and 
 the second tube portion is connected to the first tube portion at the second end. 
   
     
     
         34 . The apparatus of  claim 31 , wherein a majority of the catheter is contained within the second tube portion. 
     
     
         35 . The apparatus of  claim 31 , wherein the sheath comprises a protecting portion and a constraining portion disposed over the scaffold, wherein the protecting portion is located between the constraining portion and the scaffold. 
     
     
         36 . The apparatus of  claim 35 , wherein the sheath is a one-piece sheath. 
     
     
         37 . The apparatus of  claim 35 , wherein the sheath is a two-piece sheath comprising a first sheath and a second sheath disposed over the first sheath, wherein the first sheath is the protecting portion and the second sheath is the constraining portion. 
     
     
         38 . The apparatus of  claim 31 , wherein the first tube portion and the second tube portion are separate tubes that are attached and held together by any combination of a sleeve, tape and clip.