Bifurcated intraluminal prostheses construction and methods
First Claim
1. A branching endoluminal stent-graft comprising:
- a flexible liner having a main body with a common lumen, a first branch having a first branch lumen, and a second branch having a second branch lumen, the first and second branch lumens being in communication with the common lumen; and
a radially expandable frame disposed over at least a portion of the liner, the frame defining a frame lumen cross-section having a first lobe supporting the first branch, a second lobe supporting the second branch, and at least one isthmus therebetween.
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Abstract
The present invention provides modular bifurcated intraluminal tubular prostheses, particularly stents and stent-grafts, for the treatment of disease conditions, particularly aneurysms. Modular sections of the prostheses, or “prosthetic modules,” may be selectively assembled to form a prosthesis having characteristics which are tailored to the specific requirements of the patient, including branch angle and branch lumen sizes which match the patients vascular geometry. A Y-connector prosthetic module structure provides support and separation for each of the adjacent branching lumens. Radiopaque markers on the prostheses promote alignment between prosthetic modules and with the body lumen system.
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Citations
70 Claims
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1. A branching endoluminal stent-graft comprising:
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a flexible liner having a main body with a common lumen, a first branch having a first branch lumen, and a second branch having a second branch lumen, the first and second branch lumens being in communication with the common lumen; and
a radially expandable frame disposed over at least a portion of the liner, the frame defining a frame lumen cross-section having a first lobe supporting the first branch, a second lobe supporting the second branch, and at least one isthmus therebetween. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A branching endoluminal stent-graft comprising:
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a radially expandable tubular frame; and
a flexible, inelastic liner supported by the frame, the liner having a main body with a common lumen, a first branch having a first branch lumen, and a second branch having a second branch lumen, the first and second branches extending from the main body, the first and second branch lumens being in communication with the common lumen, and a perimeter of the common lumen being smaller than a sum of a perimeter of the first branch lumen and a perimeter of the second branch lumen. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 19, 20, 21, 22, 24, 25, 26, 27, 29, 30, 31, 32, 33, 34, 36, 37, 38, 39, 40, 41, 42)
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18. An angled branch endoluminal prosthesis comprising:
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a radially expandable tubular body main body having a common lumen;
a radially expandable tubular first branch extending from the main body, the first branch having a first branch lumen in fluid communication with the common lumen when the prosthesis is expanded; and
a radially expandable tubular second branch extending from the main body, the second branch having a second branch lumen in fluid communication with the common lumen when the prosthesis is expanded;
wherein the common lumen and the first branch lumen define a first open flow path having a preset first branch angle in the range between 15° and
90°
when the prosthesis is expanded.
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23. An angled prosthetic module comprising:
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a radially expandable tubular body portion having a bend and a lumen, the lumen providing an open flow path when the bend defines a preset angle in the range between 15 and 90; and
a standard interface disposed on an end of the body portion, the standard interface fittingly engagable with any of a plurality of standard interface ends of other endoluminal prosthetic modules having differing prosthetic characteristics.
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28. An endoluminal prosthesis system comprising:
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an expandable tubular Y-connector module having a common lumen, a first branch lumen, and a second branch lumen, the first and second branch lumens being in communication with the common lumen; and
a plurality of radially expandable prosthetic modules, each module having a tubular body portion and an end which fittingly engages at least one of the common lumen, the first branch lumen, and the second branch lumen;
wherein the plurality of body portions provide different selectable assembled endoluminal prosthetic characteristics.
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35. An endoluminal prosthetic Y-connector module comprising:
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a radially expandable body portion having a common lumen, a first branch lumen, and a second branch lumen, the first and second branch lumens being in communication with the common lumen; and
at least one standard interface end disposed on the body portion adjacent to at least one of the common lumen, the first branch lumen, and the second branch lumen, each standard interface end being fittingly engagable with any of an associated plurality of standard interface ends of other endoluminal prosthetic modules having differing prosthetic characteristics.
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43. A position-indicating stent-graft comprising:
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a radially expandable tubular frame;
a flexible liner supported by the frame;
an attachment mechanism which holds the liner on the frame; and
markers disposed on at least one of the frame, the liner, and the attachment mechanism, the markers visible under imaging to indicate at least one of axial and rotational position of the stent-graft. - View Dependent Claims (44, 45, 46, 47, 48, 49)
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50. A stent-graft placement method comprising:
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inserting a branching stent-graft into a patient body and positioning the branching stent-graft at a target location within a body lumen;
expanding the branching stent-graft at the target location, the branching stent-graft comprising a tubular frame and a flexible liner;
supporting the liner with the frame at a first cross-section so that the frame holds a common lumen open;
supporting the liner with the frame at a second cross-section so that a first lobe of the frame holds a first lumen of the liner open, and a second lobe of the frame holds a second lumen of the liner open; and
separating the first lumen from the second lumen with an isthmus of the frame disposed between the first lobe and the second lobe. - View Dependent Claims (51, 52, 53, 54)
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55. A branching endoluminal stent-graft placement method comprising;
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inserting a branching stent-graft into a patient body and positioning the branching stent-graft at a target location within a body lumen;
expanding the branching stent-graft at the target location, the branching stent-graft comprising a tubular frame and an inelastic liner; and
holding the liner in an open configuration with the frame so that a perimeter of a common lumen of the liner is smaller than a sum of a perimeter of a first branch lumen of the liner and a perimeter of a second branch lumen of the liner. - View Dependent Claims (56, 57, 59, 60, 61, 62)
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58. A method for treating a bent target region of a body lumen comprising:
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inserting an endoluminal prosthesis into the body lumen in a radially compressed configuration, the prosthesis having a bend defining a preset angle when in an expanded configuration;
positioning the prosthesis at the bent target region;
rotationally aligning the preset angle of the prosthesis with the bent target region; and
expanding the aligned prosthesis at the bent target region.
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63. A method for producing a branching stent-graft comprising:
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producing a flexible tubular liner having a main body, a first branch extending from the main body and a second branch extending from the main body;
selectively shrinking at least a portion of the main body relative to at least one of the first branch and the second branch;
attaching a radially compressible frame to the tubular liner. - View Dependent Claims (64)
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65. A method for producing a branching endoluminal prosthesis, the method comprising:
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fabricating a resilient tubular frame;
expanding the frame to an expanded configuration;
heat-treating the expanded frame while restraining the expanded frame so that a cross-section of the frame defines two lobes separated by at least one indentation;
attaching a flexible liner to a first lobe and an adjacent portion of the at least one indentation so that a first lumen of the liner is held open by the frame.
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66. A modular endoluminal prosthesis placement method comprising:
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inserting a Y-connector prosthetic module within a body lumen system;
positioning a main body of the Y-connector prosthetic module at a target location of a body lumen, the target location adjacent to first and second branch lumens of the body lumen system;
radially expanding the first prosthetic module at the target location;
selecting a preferred first branch prosthetic module from a plurality of alternative branch prosthetic modules having differing prosthetic characteristics; and
positioning an end of the preferred first branch prosthetic module within the first branch of the body lumen system and radially expanding the preferred first branch prosthetic module, the expanded preferred first branch prosthetic module engaging the Y-connector prosthetic module. - View Dependent Claims (68, 69)
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67. A method for assembling endoluminal prosthetic modules within a body lumen, the method comprising:
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deploying a first tubular prosthetic module within the body lumen;
inserting a second tubular prosthetic module into the body lumen in a radially compressed configuration;
aligning an image of markings disposed on at least one of the first prosthetic module and the second prosthetic module with an image of the other of the first prosthetic module and the second prosthetic module; and
expanding an end of the aligned second prosthetic module to engage an end of the first prosthetic module.
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70. A method for positioning endoluminal prosthetic modules within a body lumen, the method comprising:
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inserting a tubular prosthesis into the body lumen in a radially compressed configuration;
imaging markings disposed on the inserted prosthetic module;
rotationally orienting an asymmetric marker element and bringing together the image of marker disposed at different radial locations about the prosthesis to align the prosthesis; and
expanding the aligned prosthesis within the body lumen.
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Specification