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EP-3576672-B1 - PRE-STRAINED STENT ELEMENTS

EP3576672B1EP 3576672 B1EP3576672 B1EP 3576672B1EP-3576672-B1

Inventors

  • SILVERMAN, JAMES D.
  • BAYKOVA, Olga

Dates

Publication Date
20260506
Application Date
20180129

Claims (14)

  1. A self-expanding endoprosthesis having a reduced configuration and a deployed configuration, the self-expanding endoprosthesis comprising: a self-expanding stent element (402) having an enlarged diameter; the self-expanding stent being configured to exhibit plastic strain in response to being reduced to the reduced configuration and at the deployed diameter; and a graft component (404) attached to at least a portion of the self-expanding stent element and having an enlarged diameter less than the enlarged diameter of the self-expanding stent element in the deployed configuration; wherein in the deployed configuration, the self-expanding stent element (402) exerts a radially expansive force to the graft component (404); the graft component (404) having a yield strength greater than the radially expansive force and being configured to radially maintain the self-expanding stent element (402) at the enlarged diameter of the graft component upon application of a second radially expansive force greater than the radially expansive force of the self-expanding stent element (402) wherein the self-expanding stent element comprises a plurality of undulations formed by struts (414, 418) connecting apices (416, 420) wherein the apices (416, 420) include intradoses (422, 426) and extradoses (424, 428).
  2. The self-expanding endoprosthesis of claim 1, wherein the graft component is configured to resist plastic deformation upon application of the second radially expansive force.
  3. The self-expanding endoprosthesis of any one of claims 1-2, wherein the enlarged diameter of the self-expanding stent element is from 2% to 25% greater than the enlarged diameter of the graft component.
  4. The self-expanding endoprosthesis of any one of claims 1-3, wherein the graft component is a continuous structure attached to the self-expanding stent element forming a flow lumen of the self-expanding endoprosthesis.
  5. The self-expanding endoprosthesis of claim 1, wherein the graft component is configured to reduce tensile stress in the intradoses (422, 426) of the apices (416, 420).
  6. The self-expanding endoprosthesis of claim 1, wherein the graft component is configured to maintain compression of the intradoses (422, 426) of the apices (416, 420).
  7. The self-expanding endoprosthesis of claim 6, wherein the self-expanding stent element (402) and the graft component (404) are reduced to a reduced configuration, and the intradoses (422, 426) of the apices (416, 420) remain in compression after expansion to the deployed configuration.
  8. The self-expanding endoprosthesis of any one of claims 1-7, wherein the self-expanding stent element (402) is heat set to a manufactured diameter.
  9. The self-expanding endoprosthesis of claim 8, wherein the manufactured diameter of the self-expanding stent element (402) is from 15% to 20% greater than the enlarged diameter of the graft component (404).
  10. The self-expanding endoprosthesis of any one of claims 1-9, wherein the manufactured diameter of the self-expanding stent (402) element is from approximately 1 mm to 3 mm greater than the enlarged diameter of the graft component (404).
  11. The self-expanding endoprosthesis of any one of claims 1-10, wherein the self-expanding stent element (402) and the graft component (404) are configured to compress to a reduced diameter from 1.33 to 8.67 mm (4 French to 26 French).
  12. The self-expanding endoprosthesis of claim 11, wherein the enlarged diameter of the graft component (404) is from 2 mm to 53 mm.
  13. The self-expanding endoprosthesis of any one of claims 1-12, wherein the self-expanding stent element (402) with a manufactured diameter of from 7 mm to 32 mm and the graft component (404) has an expanded diameter of from 5 mm to 27 mm.
  14. The self-expanding endoprosthesis of claim 13, wherein the graft component is configured to resist a radially expansive force greater than an outward force from the self-expanding stent element (402) without expanding beyond the expanded diameter of the graft component (404), and the radially expansive force is between 304 kPa to 608 kPa (3 atm and 6 atmosphere atm).

Description

BACKGROUND Medical stents, grafts, and stent-grafts have a variety of uses including to expand a body lumen, such as a blood vessel, which has contracted in diameter. The blood vessels may be diseased, contracted or otherwise damaged due to, for example, the effects of lesions called atheroma or the occurrence of cancerous tumors. Atheroma refers to lesions within arteries that include plaque accumulations that can obstruct blood flow through the vessel. Over time, the plaque can increase in size and thickness and can eventually lead to clinically significant narrowing of the artery, or even complete occlusion. When expanded against the body lumen, which has contracted in diameter, the medical stents provide a tube-like support structure inside the body lumen. Additional, non-limiting examples of stent, graft and/or stent-graft applications include the endovascular repair of aneurysms, an abnormal widening or ballooning of a portion of a body lumen which can be related to weakness in the wall of the body lumen. US 6110198 describes a modular intraluminal tubular prostheses, particularly stents and stent-grafts for the treatment of disease conditions, particularly aneurysms. Modular selections of the prosthesis, or "prosthetic modules" may be selectively combined to form a composite prosthesis having characteristics which are tailored to the specific requirements of the patient. Each prosthetic module preferably includes one or more standard interface ends for engaging another module, the module/module interface typically comprising ends which overlap and/or lock within a predetermined axial range. Advantageously, the axial length, cross section, perimeter, resilient expansive force, axial flexibility, linear permeability, liner extensibility, radial conformability, liner/tubal wall sealing and anchoring, and other prosthetic characteristics may be varied along the axis of the composite prosthesis, and also along the axis of each prosthetic module. SUMMARY Various aspects of the present disclosure are directed toward self-expanding endoprosthesis having a reduced configuration and a deployed configuration. The self-expanding endoprosthesis may include a self-expanding stent element having an enlarged diameter and a graft component attached to at least a portion of the self-expanding stent element and having an enlarged diameter less than the enlarged diameter of the self-expanding stent element in the deployed configuration. In addition and in the deployed configuration, the self-expanding stent element may exert a radially expansive force to the graft component. The graft component may have a yield strength greater than the radially expansive force and being configured to radially maintain the self-expanding stent element at the enlarged diameter of the graft component upon application of a second radially expansive force greater than the radially expansive force of the self-expanding stent element. Aspects of the disclosure are also directed toward a self-expanding endoprosthesis having a self-expanding stent element with a manufactured diameter of from 7 mm to 32 mm and a graft component with an expanded diameter of from 5 mm to 27 mm. The self-expanding stent element may include a self-deployed diameter of is at least from 2% to 25% greater than the expanded diameter of the graft component. In addition, the expanding stent element may be attached at least in part to the graft component. Further, when the self-expanding endoprosthesis is fully deployed, the self-expanding stent element may continue to apply outward force against the graft component without expanding beyond the expanded diameter of the graft component. Various aspects of the present disclosure are also directed toward a self-expanding endoprosthesis that include a self-expanding stent element having a neutral diameter of from 22 mm to 58 mm and a graft component with an expanded diameter of from 20 mm to 53 mm and attached to the self-expanding stent element. The self-expanding stent element and the graft component may be configured to reduce to a delivery configuration from a fully-deployed configuration for introduction into a patient. In addition, a self-deployed diameter of the self-expanding stent element may be at least from 2% to 25% greater than the expanded diameter of the graft component with the graft component being configured to maintain the self-expanding stent element at the expanded diameter of the graft component. Aspects of the present disclosure are further directed toward a self-expanding endoprosthesis having a reduced configuration and a deployed configuration. The self-expanding endoprosthesis may include a self-expanding stent element having an enlarged diameter and a diametric constraint coupled to at least a portion of the self-expanding stent element. The diametric constraint may be configured to constrain the portion of the self-expanding stent to an enlarged diameter less than the enlarged diameter of the self-