CLIP SHEATH FOR A POLYMER SCAFFOLD

• US 20150088240A1
• Filed: 09/25/2013
• Published: 03/26/2015
• Est. Priority Date: 09/25/2013
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Lam, Stan, Anderson-Bolden, Erika Danielle
• Granted Patent: US 10,098,771 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 2/958 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: Y10T 156/1002 with permanent bending or reshaping or surface deformation of self sustaining lamina
• CPC Class Codes: Y10T 29/49822 by applying force

Abstract

A sheath is placed over a crimped scaffold 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 has an opening spanning the length of the sheath. The opening spans an arc length of about 90 degrees with respect to the circumference of the scaffold or balloon. The sheath may be removed from the scaffold by pinching the sheath between a thumb and forefinger, or bending or peeling back the sheath from the edges of the opening using fingertips.

Claims

1. An apparatus, comprising:

a catheter including a scaffold comprising a polymer, the scaffold being crimped to a balloon; and

a constraining sheath disposed over the scaffold, the sheath comprising two edges defining an opening, the edges being circumferentially spaced from each other by between 5 Degrees and 150 Degrees;

wherein the catheter is capable of being introduced into a body only after the sheath is removed from the scaffold.

2. The apparatus of claim 1, wherein each of the two edges extend over the entire length of the sheath.

3. The apparatus of claim 2, wherein the between 50 Degrees and 150 Degrees circumferential spacing is about constant over the entire length.

4. The apparatus of claim 2, wherein the sheath has a non-circular outer surface.

5. The apparatus of claim 4, wherein the sheath has a notch and the sheath is symmetric about an axis passing through the notch and a longitudinal axis of the scaffold.

6. The apparatus of claim 4, wherein the sheath outer surface comprises a concave surface or the sheath outer surface comprises at least two longitudinally-extending ridges.

7. The apparatus of claim 1, further comprising,

a protecting sheath disposed over the scaffold,

wherein the protecting sheath is in direct contact with the scaffold and inside the constraining sheath.

8. The apparatus of claim 7, wherein the protecting sheath is a one or two piece sheath comprising halves or separate portions, respectively, wherein when the protecting sheath is disposed over the scaffold, edges of adjacent halves or portions are brought together to form a tubular body.

9. The apparatus of claim 8, wherein the edges of adjacent halves or portions are not within the opening defined by the constraining sheath edges.

10. The apparatus of claim 8, wherein the protecting sheath thickness is about 50% of the constraining sheath thickness.

11. The apparatus of claim 1, wherein the sheath is configured for being removed from the scaffold by pinching the two edges together, or by peeling the two edges away from each other as the sheath is lifted off the scaffold.

12. The apparatus of claim 11, wherein the sheath is not configured for being moved longitudinally relative to the scaffold when the sheath is being removed from the scaffold.

13. A tube comprising the apparatus of claim 1 contained within a lumen of the tube.

15. The method of claim 13, further comprising:

crimping the medical device to a balloon;

placing a temporary sheath over the medical device;

removing the temporary sheath from the medical device; and

placing the constraining sheath over the medical device after the temporary sheath is removed.

19. The apparatus of claim 1, wherein the edges are circumferentially spaced from each other by between 5 to 20 Degrees or 50 to 150 Degrees.

20. The apparatus of claim 1, wherein the edges are circumferentially spaced from each other by between 5 to 20 Degrees or 50 to 150 Degrees.

14. A method of making a medical device, comprising the steps of:

crimping the medical device to a balloon; and

placing a constraining sheath over the crimped medical device, the constraining sheath comprising two edges defining an opening, when placed over the crimped medical device the edges are circumferentially spaced from each other by between 5 Degrees and 150 Degrees;

wherein the medical device is capable of being implanted within a body only after the constraining sheath has been removed from the medical device.

16. A tubular medical device, comprising:

a sheath disposed over the medical device, wherein the medical device is configured for being radially expanded;

the sheath circumscribing at most between about 70% to 98% of the medical device;

wherein the medical device is capable of being introduced into a body only after the sheath is removed from the medical device.

17. The medical device of claim 16, wherein the medical device is a stent or a scaffold.

18. A method for removing a sheath from a crimped scaffold, comprising:

applying pressure to opposite sides of the sheath; and

pinching together, or peeling away edges of the sheath from the scaffold to remove the sheath from the scaffold.