Controlled endoprosthesis balloon expansion

• US 10,568,752 B2
• Filed: 05/25/2016
• Issued: 02/25/2020
• Est. Priority Date: 05/25/2016
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Kovach, Larry J., Koenig, Joseph B.
• Primary Examiner(s): Aleman, Sarah W
• Application Number:
  US15/164,657
• Publication Number:
  US 20170340464A1
• Time in Patent Office: 1,371 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• 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 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0019 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• 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 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril

Abstract

A medical assembly includes a balloon expandable endoprosthesis comprising a plurality of ringed stent elements flexibly connected to each other via at least one flexible connector, the endoprosthesis being deployable from an undeployed state with an undeployed diameter to a deployed state with a deployed diameter. The medical assembly further includes a catheter assembly comprising a balloon, and a cover along the balloon. The endoprosthesis is coaxially located about the balloon and the cover. One or more portions of the balloon and the cover reach an intermediate diameter between the undeployed diameter and the deployed diameter in which the portions of the balloon and the cover are inflated by increasing an inflation pressure within the balloon and approximately maintained at about the intermediate diameter until the inflation pressure increases by at least 1 atmosphere to overcome a yield strength of the cover.

Claims

1. A medical assembly, comprising:

balloon expandable endoprosthesis having a first end and a second end, the endoprosthesis being deployable from an undeployed state with an undeployed diameter to a deployed state with a deployed diameter; and

a catheter assembly onto which the endoprosthesis is assembled, the catheter assembly comprising;

a balloon; and

a cover along the balloon, wherein the endoprosthesis is coaxially located about the balloon and the cover,

wherein an end portion of the balloon and the cover are configured to inflate to cause an end portion of the endoprosthesis to expand to an end portion intermediate diameter that is greater than the undeployed diameter and less than the deployed diameter, and a middle portion of the balloon and cover are configured to inflate to cause a middle portion of the endoprosthesis to expand to a middle portion intermediate diameter that is less than the end portion intermediate diameter, upon increasing an inflation pressure within the balloon to a first inflation pressure, the catheter assembly being configured such that the middle portion intermediate diameter and the end portion intermediate diameter can be maintained as the inflation pressure within the balloon is increased beyond the first inflation pressure and until the inflation pressure increases by at least 1 atmosphere to overcome a yield strength of the cover such that the cover plastically deforms, at least in part, such that the middle portion and the end portions of the balloon and the cover further inflate to cause the endoprosthesis to expand from the middle portion intermediate diameter and the end portion intermediate diameter to the deployed diameter such that the middle portion and the end portion have substantially equalized diameters in the deployed state.

2. The medical assembly of claim 1, wherein a profile of the medical assembly as measured about the endoprosthesis in the undeployed state is between about 5 to about 10 French.

3. The medical assembly of claim 2, wherein a thickness of the cover on the medical assembly in the undeployed state is between about 0.025 to about 0.051 millimeters.

4. The medical assembly of claim 1, wherein a radial strength of the cover provides resistance to inflation of the balloon and is configured to counteract variable resistance of the endoprosthesis to expansion of the balloon to mitigate uneven expansion of the endoprosthesis during expansion from the undeployed diameter to the deployed diameter.

5. The medical assembly of claim 1, wherein the cover concentrically surrounds the balloon about an entire length of the balloon.

6. The medical assembly of claim 1, wherein the cover provides a greater radial strength at one or both ends of the balloon as compared to a radial strength at a middle portion of the balloon.

7. The medical assembly of claim 1, wherein the cover comprises a frangible layer designed to rupture at the middle portion intermediate diameter or the end portion intermediate diameter with the ultimate strength of the frangible layer contributing to the yield strength of the cover to resist expansion beyond the middle portion intermediate diameter or the end portion intermediate diameter.

8. The medical assembly of claim 1, wherein the cover comprises a pre-stretched layer configured to provide increased resistance to expansion due to the yield strength of the cover to resist expansion beyond the middle portion intermediate diameter or the end portion intermediate diameter.

9. The medical assembly of claim 1, wherein the balloon includes a material selected from a group consisting of:

a compliant material;

a semi-compliant material; and

a noncompliant material.

10. The medical assembly of claim 1, wherein the deployed diameter is at least 11 millimeters.

11. The medical assembly of claim 1, wherein the endoprosthesis further comprises a plurality of ringed stent elements flexibly connected to each other via at least one flexible connector, with ringed stent elements proximate the first end and the second end.

12. The medical assembly of claim 11, wherein the middle portion and the end portion of the balloon and the cover that reach the middle portion intermediate diameter and the end portion intermediate diameter until the inflation pressure increases by at least 1 atmosphere to overcome a yield strength of the cover includes substantially all portions of the balloon and the cover adjacent to the endoprosthesis such that each of the plurality of ringed stent elements approximately reach the middle portion intermediate diameter and the end portion intermediate diameter until the inflation pressure increases by the at least 1 atmosphere to overcome a yield strength of the cover.

13. The medical assembly of claim 11,

wherein the endoprosthesis includes a stent-graft,

wherein the flexible connector includes a graft material, and

wherein the plurality of ringed stent elements are connected to one another only via nonmetallic materials including the flexible connector.

14. The medical assembly of claim 11, wherein the flexible connector includes flexible longitudinal connectors.

15. The medical assembly of claim 11, wherein the cover is configured to limit uneven expansion of adjacent ringed stent elements during deployment to prevent a foreshortening force due to uneven expansion of adjacent ringed stent elements from exceeding a frictional force between the cover and the endoprosthesis, and

wherein due to the limited uneven expansion of adjacent ringed stent elements, the endoprosthesis does not foreshorten during expansion from the undeployed diameter to the deployed diameter.

16. A method of implanting endoprosthesis comprising:

inserting a distal end of a medical assembly into a vasculature of a patient, wherein the medical assembly comprises;

a balloon expandable endoprosthesis having a first end and a second end, the endoprosthesis being deployable from an undeployed state with an undeployed diameter to a deployed state with a deployed diameter; and

a catheter assembly onto which the endoprosthesis is assembled, the catheter assembly comprising;

a balloon; and

a cover along the balloon, wherein the endoprosthesis is coaxially located about the balloon and the cover,

wherein an end portion of the balloon and the cover are configured to inflate to cause an end portion of the endoprosthesis to expand to an end portion intermediate diameter that is greater than the undeployed diameter and less than the deployed diameter and a middle portion of the balloon and cover are configured to inflate to cause a middle portion of the endoprosthesis to expand to a middle portion intermediate diameter that is less than the end portion intermediate diameter, upon increasing an inflation pressure within the balloon to a first inflation pressure,

the catheter assembly being configured such that the middle portion intermediate diameter and the end portion intermediate diameter can be maintained as the inflation pressure within the balloon is increased beyond the first inflation pressure and until the inflation pressure increases by at least 1 atmosphere to overcome a yield strength of the cover such that the cover plastically deforms, at least in part, such that the middle portion and the end portions of the balloon and the cover further inflate to cause the endoprosthesis to expand from the middle portion intermediate diameter and the end portion intermediate diameter to the deployed diameter such that the middle portion and the end portion have substantially equalized diameters in the deployed state,

the method further comprising, delivering, with the medical assembly, the endoprosthesis mounted over the balloon to a treatment site within the vasculature of the patient or another vasculature of the patient; and

remotely inflating the balloon to expand the endoprosthesis from the undeployed diameter to the deployed diameter.

17. The method of claim 16, wherein remotely inflating the balloon comprises:

inflating the balloon to a first inflation pressure to cause the end portion of the endoprosthesis to expand to the end portion intermediate diameter and the middle portion of the endoprosthesis to expand to the middle portion;

increasing the inflation pressure within the balloon from the first inflation pressure to less than 1 atmosphere above the first inflation pressure without causing the diameter of the endoprosthesis to increase from the end portion intermediate diameter and the middle portion intermediate diameter; and

increasing inflation pressure by at least 1 atmosphere above the first inflation pressure to cause the cover to yield such that the middle portion and the end portion of the balloon and the cover further inflate to cause the endoprosthesis to expand from the middle portion intermediate diameter and the end portion intermediate diameter to the deployed diameter.

18. The method of claim 16, the endoprosthesis further comprising a plurality of ringed stent elements flexibly connected to each other via at least one flexible connector, with ringed stent elements proximate the first end and the second end.

19. A method of making a deployment system comprises assembling balloon expandable endoprosthesis having a first end and a second end to a catheter assembly comprising an expandable balloon and a cover such that the endoprosthesis is mounted over the balloon and the cover with the endoprosthesis being deployable via expansion of the balloon, the endoprosthesis providing an balloon undeployed diameter and a balloon deployed diameter,

the endoprosthesis being deployable from an undeployed state with an endoprosthesis undeployed diameter to a deployed state with an endoprosthesis deployed diameter,

wherein an end portion of the balloon and the cover reach an end portion intermediate diameter between the balloon undeployed diameter and the balloon deployed diameter,

and a middle portion of the balloon and the cover reach a middle portion intermediate diameter that is less than the end portion intermediate diameter, in response to an inflation pressure within the balloon increasing to a first inflation pressure,

and wherein the balloon is configured such that the balloon can be maintained at approximately the middle portion intermediate diameter and the end portion intermediate diameter as the inflation pressure within the balloon is increased beyond the first inflation pressure and until the inflation pressure increases by at least 1 atmosphere to overcome a yield strength of the cover at which point the cover is configured to yield such that the middle portion and the end portion of the balloon and the cover further inflate to the balloon deployed diameter such that the middle portion and the end portion have substantially equalized diameters in the deployed state to cause the endoprosthesis to expand to the endoprosthesis deployed diameter.

20. The method of claim 19, further comprising, prior to assembling the endoprosthesis to the catheter assembly, pre-stretching the cover by inflating the balloon and the cover to the middle portion intermediate diameter or the end portion intermediate diameter.

21. The method of claim 19, wherein the endoprosthesis comprises a plurality of ringed stent elements flexibly connected to each other via at least one flexible connector, with ringed stent elements proximate the first end and the second end.

22. A medical assembly, comprising:

A balloon expandable endoprosthesis having a first end and a second end, the endoprosthesis being deployable from an undeployed state with an undeployed diameter to a deployed state with a deployed diameter; and

a catheter assembly onto which the endoprosthesis is assembled, the catheter assembly comprising;

a balloon; and

a cover coupled to the balloon, wherein the endoprosthesis is coaxially located about the balloon and the cover,

wherein the deployed diameter is at least 11 millimeters,

and wherein an end portion of the balloon and the cover are configured to cause an end portion of the endoprosthesis to expand to an end portion intermediate diameter between the undeployed diameter and the deployed diameter,

and a middle portion of the balloon and the cover are configured to inflate to cause a middle portion of the endoprosthesis to expand to a middle portion intermediate diameter that is less than the end portion intermediate diameter, in response to an inflation pressure within the balloon increasing to a first inflation pressure,

and wherein the balloon is configured such that the balloon can be maintained at approximately the middle portion intermediate diameter and the end portion intermediate diameter until the inflation pressure increases by at least 1 atmosphere to overcome a yield strength of the cover at which point the cover is configured to yield such that the balloon is operable to expand the endoprosthesis to the deployed diameter such that the middle portion and the end portion have substantially equalized diameters in the deployed state.

23. The medical assembly of claim 22, the endoprosthesis further comprising a plurality of ringed stent elements flexibly connected to each other via at least one flexible connector, with ringed stent elements proximate the first end and the second end,

wherein the cover is configured to limit uneven expansion of adjacent ringed stent elements during deployment to prevent a foreshortening force due to uneven expansion of adjacent ringed stent elements from exceeding a frictional force between the cover and the endoprosthesis, and

wherein due to the limited uneven expansion of adjacent ringed stent elements, the endoprosthesis does not foreshorten during expansion from the undeployed diameter to the deployed diameter.

24. The medical assembly of claim 23, wherein the limited uneven expansion of adjacent ringed stent elements results in an angle of no greater than 35 degrees relative to a longitudinal axis of the endoprosthesis.