Balloon expandable endoprosthesis

• US 10,299,948 B2
• Filed: 11/24/2015
• Issued: 05/28/2019
• Est. Priority Date: 11/26/2014
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Bohn, Jane K., Hartman, Cody L., Kanjickal, Deenu G., Kilgrow, Bret J., Koenig, Joseph B., Nickerson, James J., Triebes, Thomas G.
• Primary Examiner(s): Severson, Ryan J.
• Application Number:
  US14/950,165
• Publication Number:
  US 20160143759A1
• Time in Patent Office: 1,281 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2240/008 Means for testing implantable prostheses
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• 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 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• 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: A61M 25/104 used for angioplasty

Abstract

An improved medical device reduces the loss of longitudinal length during expansion of a stent-graft from a compressed state to an expanded state. For example, the stent-graft is placed over a cover that provides resistance to expansion of the balloon during inflation, which reduces longitudinal compressing forces exerted on the stent-graft.

Claims

1. A medical device, comprising:

a stent-graft defining a first free end, a second free end, and an intermediate portion between the first and second free ends, the stent-graft having an undeployed state with an undeployed diameter and an undeployed longitudinal length between the first free end and the second free end and a deployed state with a deployed diameter and a deployed longitudinal length between the first free end and the second free end, the stent-graft including a stent portion and a graft portion; and

a catheter assembly onto which the stent-graft is assembled in the undeployed state, the catheter assembly including,

a balloon, and

a cover including a middle portion situated between first and second end portions of the cover, the cover concentrically surrounding the balloon such that the first and second end portions of the cover impart a resistance to expansion of the balloon that exceeds a resistance to expansion imparted to the balloon by the middle portion of the cover, the stent-graft disposed about the cover and the balloon such that the intermediate portion of the stent-graft in combination with the cover imparts a resistance to expansion of the balloon at the intermediate portion of the stent-graft that exceeds the resistance imparted on the balloon by the first and second end portions of the cover, wherein a difference in an expansion rate of the balloon at the first and second free ends of the stent-graft is reduced relative to an expansion rate of the balloon at the intermediate portion of the stent-graft so as to reduce longitudinal compression of the stent-graft as the balloon expands the stent-graft from its undeployed state to its deployed state.

2. The medical device of claim 1, wherein the deployed longitudinal length of the stent-graft is at least 85% of the undeployed longitudinal length of the stent-graft.

3. The medical device of claim 1, wherein the first and second ends of the cover each include reinforcing portions configured to resist inflation of corresponding shoulder portions of the balloon so as to reduce longitudinal compression of the stent-graft as the balloon expands the stent-graft from its undeployed state to its deployed state.

4. The medical device of claim 1, wherein the stent portion of the stent graft includes a plurality of ring stent elements that are separate components connected by the graft portion of the stent-graft.

5. The medical device of claim 1, wherein the graft portion is configured to store longitudinal length of the stent-graft when the stent-graft is in the undeployed state.

6. The medical device of claim 1, wherein the graft portion of the stent-graft is formed of ePTFE.

7. A medical device, comprising:

a stent-graft defining a first free end, a second free end, and an intermediate portion between the first and second free ends, the stent-graft having an undeployed state with undeployed longitudinal length between the first free end and the second free end and a deployed state with a deployed longitudinal length between the first free end and the second free end, the stent-graft including,

a stent portion, and

a graft portion; and

a catheter assembly onto which the stent-graft is assembled in the undeployed state, the catheter assembly including,

a balloon, and

a cover including a middle portion situated between first and second end portions of the cover, the cover concentrically surrounding the balloon such that the first and second end portions of the cover impart a resistance to expansion of the balloon that exceeds a resistance imparted to the balloon by the middle portion of the cover, the stent-graft disposed about the cover and the balloon such that the intermediate portion of the stent-graft in combination with the cover imparts a resistance to expansion of the balloon at the intermediate portion of the stent-graft that exceeds the resistance to expansion imparted to the balloon by the first and second end portions of the cover, wherein the deployed longitudinal length of the stent-graft is at least 85% of the undeployed longitudinal length of the stent-graft.

8. The medical device of claim 7, wherein the graft portion of the stent-graft is formed of ePTFE.

9. A medical device comprising:

a stent-graft including;

an inner ePTFE graft element,

an outer ePTFE graft element, and

a multiplicity of ringed stent elements positioned between the inner ePTFE graft element and the outer ePTFE graft element,

the stent-graft having an undeployed state with a undeployed diameter and a deployed state with a deployed diameter greater than the undeployed diameter; and

a catheter assembly including a balloon concentrically surrounded by a cover, the cover including a middle portion situated between reinforcing portions, the reinforcing portions being configured to resist inflation of corresponding shoulder portions of the balloon, wherein the reinforcing portions of the cover impart a resistance to expansion of the corresponding shoulder portions of the balloon that exceeds a resistance to expansion imparted to the balloon by the middle portion of the cover, wherein the stent-graft is disposed about a portion of the cover such that a resistance to expansion of the balloon along the stent-graft exceeds the resistance to expansion of the corresponding shoulder portions imparted to the balloon by the reinforcing portions of the cover so as to reduce longitudinal compression of the stent-graft as the balloon expands the stent-graft from its undeployed state to its deployed state.

10. The medical device of claim 9, wherein the reinforcing portions of the cover maintain an expansion profile of the balloon that diminishes an amount of radial expansion of the shoulder portions of the balloon relative to a middle portion of the balloon as the balloon is inflated.

11. The medical device of claim 9, wherein the multiplicity of ringed stent elements are configured to store longitudinal length when the stent-graft is in the undeployed state.

12. The medical device of claim 9, wherein the stent-graft has an undeployed length in the undeployed state and a deployed length in the deployed state, wherein the deployed length is between 85% and 99% of the undeployed length.

13. The medical device of claim 9, wherein the multiplicity of ringed stent elements comprise interconnected wire frames.

14. The medical device of claim 9, wherein the multiplicity of ringed stent elements comprise a single row of interconnected diamond shaped wire frames.

15. The medical device of claim 9, wherein an apex of a first ringed stent element is out of phase with an adjacent apex of a second ringed stent element along a longitudinal axis.

16. A medical device, comprising:

a stent-graft having an undeployed state with an undeployed diameter and an undeployed length, and a deployed state with a deployed diameter and a deployed length, the stent-graft including;

an inner graft element;

an outer graft element; and

a plurality of ringed stent elements positioned between and attached to the inner graft element and the outer graft element; and

a catheter assembly including;

a balloon having a cone-shaped end;

a cover concentrically surrounding the balloon, the cover having a middle portion and a reinforcing portion, the reinforcing portion concentrically surrounding the cone-shaped end of the balloon, the reinforcing portion of the cover having a higher density than a density of the middle portion of the cover such that the reinforcing portion of the cover imparts a greater resistance to expansion of the cone-shaped end of the balloon relative to a resistance to expansion imparted to the balloon by the middle portion of the cover, wherein the stent-graft is disposed about a portion of the cover such that a resistance to expansion imparted to the balloon along the stent-graft exceeds the resistance to expansion imparted to the cone-shaped end of the balloon by the reinforcing portion of the cover in order to maintain an expansion profile that reduces longitudinal compression of the graft-stent.

17. The medical device of claim 16, wherein a spacing of at least some of the plurality of ringed stent elements when the stent-graft is in its undeployed state stores longitudinal length that is recovered by the stent-graft in its deployed state.

18. The medical device of claim 16, wherein the deployed length exhibits less than 1% foreshortening compared to the undeployed length.

19. The medical device of claim 16, wherein the reinforcing portion of the cover has a radial strength that is greater than a radial strength of the middle portion.

20. The medical device of claim 16, wherein the reinforcing portion of the cover restricts expansion of the cone-shaped end of the balloon during inflation of the balloon.

21. The medical device of claim 16, wherein the reinforcing portion of the cover includes an axially compressed portion of the cover.

22. The medical device of claim 16, wherein the reinforcing portion of the cover includes a pleated portion of the cover.

23. The medical device of claim 22, wherein pleatings in the pleated portion of the cover correspond to pleatings in a pleated portion of the balloon.