SHEATHS USED WITH POLYMER SCAFFOLDS

• US 20170151078A1
• Filed: 12/12/2016
• Published: 06/01/2017
• Est. Priority Date: 06/21/2011
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Speck, Marc L.
• Granted Patent: US 10,470,907 B2
• Time in Patent Office: Days
• 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

1-24. -24. (canceled)

25. An apparatus, comprising:

a catheter including a scaffold having a length, the scaffold comprises a polymer and the scaffold is crimped to a balloon of the catheter;

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

a shell forming a cylindrical protecting portion and a cylindrical handling portion, which surrounds the protecting portion, and

a compression portion located within a space between the protecting portion and the handling portion.

26. The apparatus of claim 25,

wherein the scaffold is crimped by way of plastic deformation of the scaffold to the balloon such that when the sheath is removed the scaffold retains substantially the same diameter it had when disposed within the sheath;

and

wherein the apparatus is configured into an implantable medical device only after the sheath is removed.

27. The apparatus of claim 25, wherein the sheath assembly further comprises a link connecting the protecting portion to the handling portion.

28. The apparatus of claim 27, wherein the scaffold has a length and the link extends over the length.

29. The apparatus of claim 28, wherein the compression portion includes a space extending over a length of the compression portion, and wherein the link occupies the compression portion space.

30. The apparatus of claim 25, wherein the protecting portion includes a slot extending along a length of the protecting portion.

31. The apparatus of claim 30, wherein the handling portion includes a slot extending along a length of the handling portion.

32. The apparatus of claim 25, wherein a length of the compression portion is longer than a length of the handling portion and a length of the protecting portion.

33. The apparatus of claim 32, wherein an end of the compression portion is flared, or includes a knob.

34. An apparatus, comprising:

a catheter including a scaffold having a length, the scaffold comprises a polymer and the scaffold is crimped to a balloon of the catheter;

a sheath disposed over the scaffold, the sheath comprising;

a first cylindrical member in contact with the scaffold,

a second cylindrical member applying a radially compressive force on the first cylindrical member, and

a third cylindrical member surrounding the first and second cylindrical members.

35. The apparatus of claim 34, wherein the sheath further comprises a link connecting the first and third cylindrical members.

36. The apparatus of claim 35, wherein the link extends over a length of the first and third cylindrical members.

37. The apparatus of claim 35, wherein the second cylindrical member is configured for being removed from the first cylindrical member while the third cylindrical member remains surrounding the first cylindrical member.

38. The apparatus of claim 35, wherein at least one of the first and third cylindrical members comprise a lengthwise space or slit extending over a length of the at least one of the first and third cylindrical members, the lengthwise space or slit defining half-cylinder portions of the at least one of the first and third cylindrical members.

39. The apparatus of claim 35, wherein the second cylindrical member comprises a space and the link extends through the space.

40. An apparatus, comprising:

a catheter including a scaffold having a length, the scaffold comprises a polymer and the scaffold is crimped to a balloon of the catheter;

a sheath disposed over the scaffold, the sheath including a handle that is gripped by a medical professional when the sheath is removed from the scaffold, the sheath comprising;

a first member in contact with the scaffold, the first member having a length,

a second member applying a radially compressive force on the first member, the second member including a space separating half-cylinder portions of the second member,

a link extending through the second member space and connecting the first member to the handle,

wherein the apparatus is configured into an implantable medical device only after the sheath is removed from the scaffold.

41. The apparatus of claim 40, wherein the sheath is configured for being removed from the scaffold using the following steps:

holding the handle, thereby preventing relative movement between the first member and the scaffold,

while holding the handle, removing the second member from the first member, and

after removing the second member, removing the first member from the scaffold.

42. The apparatus of claim 40, wherein the first member includes a space separating half-cylinder portions of the first member.

43. The apparatus of claim 42, wherein the first member has a first side and a second side, opposite the first side, wherein

the first member space is located on the first side, and

the second member space is distal the first side and proximal the second side.

44. The apparatus of claim 40, wherein a gap separates an outer surface of the second member from an inner surface of the handle.