Endolumenal prothesis and method of use in bifurcation regions of body lumens

• US 7,018,400 B2
• Filed: 02/17/2003
• Issued: 03/28/2006
• Est. Priority Date: 09/24/1997
• Status: Expired due to Fees

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Birdsall, Matthew J., Lashinski, Robert D., Brooks, Dennis L., Haarstad, Philip J., Peacock, James C. III, Colombo, Antonio
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US10/369,352
• Publication Number:
  US 20030167083A1
• Time in Patent Office: 1,135 Days
• Field of Search: 623/1.35, 623/1.27, 623/1.11, 623/1.16, 606/194, 606/195
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An endolumenal medical device assembly is provided for use in a bifurcation region of a body lumen. An expandable prosthesis, preferably an endolumenal support device such as a stent, is included in the assembly and is adjustable from a radially collapsed condition to a radially expanded condition. The expandable prosthesis further includes a prosthesis passageway and a side port through which the prosthesis passageway communicates externally of the prosthesis. A dilator or an access device is engaged within the prosthesis passageway and also through the side port while the expandable prosthesis is in the radially collapsed condition. By coupling a guidewire to an access device engaged within the side port and positioning the guidewire therein, the expandable prosthesis may be positioned in the bifurcation region such that its distal end portion is in a first branch lumen extending from the bifurcation, its proximal end portion is in a common proximal lumen of the bifurcation region, and the side port is aligned with an entrance zone to a second branch lumen extending from the bifurcation. When the expandable prosthesis is positioned at the bifurcation region in this orientation, the access device maintains percutaneous translumenal access to the second branch lumen through the prosthesis passageway and the side port while the expandable prosthesis is adjusted from the radially collapsed condition to the radially expanded condition. In addition, a dilator when engaged within the side port is adapted to expand the bore formed by the side port from an initial inner diameter to a larger expanded inner diameter. A second, lateral expandable prosthesis can also be coupled to the first expandable prosthesis at a location adjacent to the side port such that the dilator or access device extending through the side port is engaged within a lateral prosthesis lumen, extending through the lateral expandable prosthesis.

Claims

1. An endolumenal medical device assembly for engaging an interior surface of a body lumen wall at a bifurcation region of a body lumen, the bifurcation region including at least a first and a second branch lumen each having an entrance zone extending from a common branch lumen, comprising:

an expandable prosthesis having an elongate prosthesis body with a proximal end portion, a distal end portion, a length along a longitudinal axis extending between the proximal and distal end portions, the length defined by a plurality of generally circular members, each formed of a plurality of substantially straight segments connected at axial bends, the circular members oriented adjacent each other such that at least one axial bend of one ring is directly connected to an axial bend of an adjacent ring and a plurality of side ports defined where the axial bend of one ring is spaced from the axial bend of an adjacent ring;

a lateral expandable side port positioned along the length and defined by at least one of the generally circular members, the expandable prosthesis further being adjustable from a radially collapsed outer diameter, to a radially expanded outer diameter which is larger than the collapsed outer diameter;

a delivery member having a proximal end portion and a distal end portion which is coupled to the expandable prosthesis, the delivery member being adapted to deliver the expandable prosthesis to the bifurcation region;

an expansion member with a proximal end portion and a distal end portion which is removably engaged with the elongate prosthesis body, the distal end portion of the expansion member further being adapted to adjust the expandable prosthesis from the radially collapsed condition to the radially expanded condition when the elongate prosthesis body is engaged with the expansion member and is positioned at the bifurcation region;

a dilator with a proximal end portion and a distal end portion which is engaged within the prosthesis passageway and also within the side port when the expandable prosthesis is in the radially collapsed condition, wherein the distal end portion of the dilator is adjustable from a first dilator position, wherein the side port has an initial inner diameter, to a second dilator position, wherein the side port is dilated to an expanded inner diameter which is larger than the initial inner diameter;

a lateral expandable prosthesis having a lateral elongate prosthesis body with a proximal end portion, a distal end portion, and a lateral prosthesis lumen extending between a proximal end port located along the proximal end portion of the lateral elongate prosthesis body and a distal end port located along the distal end portion of the lateral elongate prosthesis body and a portion of the proximal end portion of the lateral expandable prosthesis is coupled to an axial bend the generally circular member defining the lateral expandable side port,

the lateral expandable prosthesis being adjustable from a second radially collapsed condition, wherein the lateral elongate prosthesis body has a second collapsed outer diameter, to a second radially expanded condition, wherein the lateral elongate prosthesis body has a second expanded outer diameter,

the proximal end portion of the lateral elongate prosthesis body being coupled to the elongate prosthesis body at a location adjacent to the side port, and

wherein the distal end portion of the dilator is engaged within the lateral prosthesis lumen such that when the dilator is adjusted from the first dilator position to the second dilator position the lateral expandable prosthesis is expanded from the second radially collapsed condition to the second radially expanded condition.

2. The endolumenal medical device assembly of claim 1, wherein the dilator further comprises:

a dilator inflation lumen extending between the proximal and distal end portions of the dilator, the distal end portion of the dilator further including an expandable balloon which is fluidly coupled to the dilator inflation lumen and which is also engaged within the side port and also within the lateral prosthesis lumen, the proximal end portion of the dilator further including a fluid coupler which is in fluid communication with the dilator inflation lumen and which is adapted to couple with a pressurizeable fluid source,

whereby coupling a pressurizeable fluid source to the fluid coupler and pressurizing the expandable balloon with fluid, the expandable balloon may be inflated from a non-expanded condition, which characterizes the first dilator position, to an expanded condition, which characterizes the second dilator position.

3. The endolumenal medical device assembly of claim 1, wherein the expanded inner diameter and the second expanded outer diameter are each within the range of 1.0 to 5.0 millimeters when the distal end portion of the dilator is adjusted from the first dilator position to the second dilator position.