Endoprosthesis and delivery system for delivering the endoprosthesis within a vessel of a patient

• US 8,608,792 B2
• Filed: 03/22/2011
• Issued: 12/17/2013
• Est. Priority Date: 11/30/2007
• Status: Active Grant

• Current Assignee: Scitech Produtos Medicos Ltda.
• Original Assignee: Scitech Produtos Medicos Ltda.
• Inventors: Curado, Luciano Almeida Fleury, Cordeiro, Eduardo Jose, Silveira, Pierre G., Dezanet, Luana Beatriz Prtile, Pires, Thiago Semo, da Silva, Douglas Jos
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US13/069,184
• Publication Number:
  US 20110224774A1
• Time in Patent Office: 1,001 Days
• Field of Search: 623/1.11, 623/1.13, 623/1.15, 623/1.16, 623/1.2, 623/1.23, 623/1.35, 606/108, 606/191, 606/194, 606/198, 606/200
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

An endoprosthesis is disclosed for implantation at a bifurcation between a main vessel and at least two secondary vessels. The endoprosthesis includes first and second bodies. Each body includes a self-expanding and flexible structure having a proximal region, an intermediate region, and a distal region. The distal region terminates at a free end. The flexible structure defines a leg and a support member adjacent to the leg. The leg terminates at the free end of the distal region. The second body is positioned within the first body. The proximal region of the first body includes a free end configured for positioning within the main vessel. The leg of the first body is configured for positioning within a first secondary vessel. The leg of the second body is configured for positioning within a second secondary vessel.

Claims

1. An endoprosthesis delivery system for implantation of an endoprosthesis at a bifurcation between a main vessel and at least two secondary vessels comprising:

an endoprosthesis, comprising;

first and second bodies, each comprising;

a self-expanding and flexible structure,

the flexible structure including a proximal region, an intermediate region, and a distal region, the distal region terminating at a free end, and

the flexible structure defining a leg and an endoprosthesis support member, the endoprosthesis support member being adjacent to and spaced apart entirely from the leg, the leg terminating at the free end of the distal region,

the second body being configured for positioning within the first body,

the proximal region of the first body including a free end configured for positioning within the main vessel, the leg of the first body being configured for positioning within a first secondary vessel, the leg of the second body being configured for positioning within a second secondary vessel; and

a delivery system, comprising;

a catheter including a proximal end and a distal end, the distal end being adapted for insertion into a vessel, the first body being positioned within the distal end of the catheter in a reduced cross-sectional condition;

a first tube, a second tube, and a third tube extending from the proximal end towards the distal end of the catheter;

a first support member and a second support member connected to the first tube, the free end of the proximal region of the first body being releasably connected to the first support member and the free end of the distal region of the first body being releasably connected to the second support member;

an outer sleeve movable along the catheter from a first position overlying the endoprosthesis to a second position spaced from the first body;

a first inner sleeve connected to the second tube for selectively covering the free end of the proximal region of the first body;

a first trigger mechanism coupled to the second tube for releasing the free end of the proximal region of the first body of the endoprosthesis from the first support member;

a second inner sleeve connected to the third tube for selectively covering the free end of the distal region of the first body; and

a second trigger mechanism coupled to the third tube to pull the second inner sleeve away from the second support member for releasing the free end of the distal region of the first body from the second support member, the first and second trigger mechanisms being movable in different directions along the catheter to release the free ends of the proximal and distal regions of the first body from the first and second support members; and

wherein the first trigger mechanism is configured to be rotated relative to the catheter to push the first inner sleeve away from the first support member to release the free end of the proximal region of the first body from the first support member.

2. The endoprosthesis delivery system recited in claim 1, wherein the second body is configured to be positioned within the first body such that the proximal region of the second body is positioned within the proximal portion of the first body, the leg of the second body extending through the endoprosthesis support member of the first body, the endoprosthesis support member of the second body extending into the leg of the first body.

3. The endoprosthesis delivery system recited in claim 2, wherein when the second body is configured to be positioned within the first body such that the free end of the proximal region of the first body is configured for attachment to a wall of the main vessel, with the proximal region of the second body cooperating with the proximal region of the first body to increase outward support within the wall of the main vessel, the leg of the first body being configured for attachment to a wall of the first secondary vessel, the leg of the second body being configured for attachment to a wall of the second secondary vessel.

4. The endoprosthesis delivery system recited in claim 1, wherein the flexible structure that forms the proximal region and the intermediate region of the first body are separate and axially spaced apart from each other to provide an unsupported portion there between in the first body, the flexible structure of the proximal region of the second body being configured to axially align with the unsupported portion of the first body when the second body is inserted in the first body.

5. The endoprosthesis delivery system recited in claim 1, wherein the proximal region of the second body includes at least one attachment member for securing the proximal region of the second body to the proximal region of the first body.

6. The endoprosthesis delivery system recited in claim 1, further comprising a lining attached to the intermediate regions of each of the first and second bodies, the free end of the proximal region of the first body and the free end of the distal region of each of the first and second bodies being free of the lining.

7. The endoprosthesis delivery system recited in claim 6, wherein the proximal region of the second body includes at least one attachment member for securing the proximal region of the second body to the proximal region of the first body.

8. The endoprosthesis delivery system recited in claim 6, wherein a portion of the lining on the first body between the proximal region and the intermediate region is unsupported by the flexible structure of the first body, the second body including a reinforcing member that is axially aligned with the unsupported portion of the lining for reinforcing the unsupported portion of the lining when the second body is positioned within the first body.

9. The endoprosthesis delivery system recited in claim 1, wherein the free end of the proximal region of the first body is larger in axial cross-section than the free end of the distal region of the first body.

10. The endoprosthesis delivery system recited in claim 1, the delivery system further comprising a locking mechanism connected to the outer sleeve and configured to move the outer sleeve from the first position to the second position.

11. The endoprosthesis delivery system recited in claim 1, the delivery system further comprising a threaded rod through which the first inner sleeve and the second inner sleeve extend, the first trigger mechanism being rotatable about the threaded rod to push the first inner sleeve away from the first support member to release the proximal region of the first body from the first support member, the second trigger mechanism being rotatable about the threaded rod to pull the second inner sleeve away from the second support member to release the distal region of the first body from the second support member.

12. An endoprosthesis delivery system for implantation of an endoprosthesis at a bifurcation between a main vessel and at least two secondary vessels comprising:

an endoprosthesis, comprising;

a first body, comprising;

a self-expanding and flexible structure, the flexible structure including a proximal region, an intermediate region, and a distal region, the proximal region terminating at a first free end;

a lining connected with and extending along the proximal region, the intermediate region, and the distal region of the flexible structure, the first free end of the flexible structure being free of the lining,

the distal region terminating at a second free end that is free of the lining, the second free end including one or more attachment loops,

the flexible structure not extending along the entire length of the lining, and

the flexible structure being configured to define a leg and an endoprosthesis support member adjacent to the leg, the leg terminating at the second free end of the distal region, the leg configured for positioning within a first secondary vessel,

a second body, comprising;

a self-expanding and flexible structure, the flexible structure of the second body including a proximal region, an intermediate region, and a distal region, the proximal region terminating at a third free end;

a lining connected with and extending along the proximal region, the intermediate region, and the distal region of the flexible structure, the third free end of the flexible structure being free of the lining,

the distal region terminating at a fourth free end that is free of the lining, and

the flexible structure configured to define a leg and an endoprosthesis support member to the leg, the leg terminating at the fourth free end of the distal region,

the second body being configured to be positioned within the first body such that the proximal region of the second body is positioned within the proximal region of the first body, the leg of the second body extending through the endoprosthesis support member of the first body and the endoprosthesis support member of the second body being aligned with and opening into the leg of the first body; and

a delivery system, comprising;

a catheter including a proximal end and a distal end, the distal end being adapted for insertion into a vessel, the first body being positioned within the distal end of the catheter in a reduced cross-sectional condition;

a first tube, a second tube, and a third tube extending from the proximal end towards the distal end of the catheter;

a first support member and a second support member connected to the first tube, the free end of the proximal region of the first body being releasably connected to the first support member, the attachment loops at the free end of the distal region of the first body being releasably received in corresponding openings in the second support member;

an outer sleeve movable along the catheter from a first position overlying the endoprosthesis to a second position spaced from the first body;

a first inner sleeve connected to the third tube for selectively covering the attachment loops at the free end of the distal region of the first body;

a first trigger mechanism coupled to the third tube for releasing the free end of the distal region of the first body of the endoprosthesis from the second support member;

wherein the first trigger mechanism is configured to be rotated relative to the catheter to pull the first inner sleeve away from the second support member to release the free end of the distal region of the first body from the second support member;

a second inner sleeve connected to the second tube for selectively covering the free end of the proximal region of the first body;

a second trigger mechanism coupled to the second inner sleeve for releasing the free end of the proximal region of the first body from the first support member; and

a threaded rod through which the first inner sleeve and the second inner sleeve extend, the first trigger mechanism being rotatable about the threaded rod to pull the first inner sleeve away from the second support member to release the distal region of the first body from the second support member, the second trigger mechanism being rotatable about the threaded rod to push the second inner sleeve away from the first support member to release the proximal region of the first body from the first support member.

13. The endoprosthesis delivery system recited in claim 12, wherein a portion of the lining on the first body between the proximal region and the intermediate region is unsupported by the flexible structure of the first body, the second body including a reinforcing member of the flexible structure that is configured for axial alignment with the unsupported portion of the lining of the first body for reinforcing the unsupported portion of the lining.

14. The endoprosthesis delivery system recited in claim 12, the delivery system further comprising a snap-in lock for releasably engaging the catheter to prevent movement of the first and second trigger mechanisms.