Sleeve for medical device assembly
The present disclosure describes a medical device assembly comprising an expandable medical device wrapped with an improved constraining sleeve. The sleeve in accordance with various embodiments of the present disclosure is thin walled and translucent, having reduced edge sharpness. The sleeve in accordance with the present disclosure exhibits resistance to ripping and delamination. Various embodiments of the present disclosure provide methods of making sheet material usable for constraining sleeves from flattened film tubes. Methods for making improved constraining sleeves and medical device assemblies that comprise an improved constraining sleeve are also disclosed herein.
1 . A constraining sleeve configured to constrain a self-expanding implantable device, the constraining sleeve comprising:
at least one layer of expanded polytetrafluoroethylene film; and
at least one reinforcing fiber encased by the expanded polytetrafluoroethylene film of the at least one layer and positioned parallel to a longitudinal axis of the self-expandable implantable device; and
an elongated coupling member woven through openings in the opposing ends of the expanded polytetrafluoroethylene film to define a releasable seam,
wherein the sleeve has a burst strength of equal to or greater than 400 psi and a wall thickness of less than about 0.12 mm.
2 . The constraining sleeve of claim 1 , wherein the sleeve is tubular, having a longitudinal axis, and wherein the at least one reinforcing fiber is embedded between layers of the sleeve, disposed substantially parallel to the longitudinal axis.
3 . The constraining sleeve of claim 1 , further comprising two reinforcing fibers.
4 . The constraining sleeve of claim 1 , having a wall thickness of less than about 0.10 mm.
5 . The constraining sleeve of claim 1 , having a wall thickness of from about 0.08 mm to about 0.10 mm.
6 . The constraining sleeve of claim 1 , having a visible light transmission of about 80% or greater.
7 . The constraining sleeve of claim 1 , having a visible light transmission of about 90% or greater.
8 . The constraining sleeve of claim 1 , having a visible light transmission of about 95% or greater.
9 . The constraining sleeve of claim 1 , wherein the at least one reinforcing fiber includes a tensile strength ranging from about 0.5 Gpa to about 2.5 Gpa or higher.
10 . The constraining sleeve of claim 1 , wherein the at least one reinforcing fiber includes an elongation to break of less than about 5%.
11 . The constraining sleeve of claim 1 , wherein the at least one reinforcing fiber includes at least one of a polyethylene fiber, a polyimide fiber, a ePTFE fiber, a polyether fiber such as polyethylene terephthalate, a polyacrylamide fiber, a liquid crystal polymer fiber, and a metal fiber.
12 . The constraining sleeve of claim 1 , wherein the at least one reinforcing fiber includes a circular cross-section with a diameter ranging from about 0.0001 mm to about 1 mm.
13 . The constraining sleeve of claim 1 , wherein the at least one reinforcing fiber extends along at least one of opposing ends of the expanded polytetrafluoroethylene film.
14 . The constraining sleeve of claim 13 , wherein the at least one reinforcing fiber is disposed within the at least one layer of expanded polytetrafluoroethylene film at the opposing ends of the expanded polytetrafluoroethylene film.
15 . The constraining sleeve of claim 14 , further comprising an elongated coupling member woven through openings in the opposing ends of the expanded polytetrafluoroethylene film to define a releasable seam.
16 . The constraining sleeve of claim 15 , wherein the at least one reinforcing fiber is disposed between the opening and an edge of the expanded polytetrafluoroethylene film.