Method for aligning a stent graft delivery system

• US 8,062,349 B2
• Filed: 01/31/2007
• Issued: 11/22/2011
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Moore, Michael, Arbefeuille, Samuel
• Primary Examiner(s): Jackson; Gary
• Assistant Examiner(s): EVERAGE, KEVIN D
• Application Number:
  US11/700,510
• Publication Number:
  US 20070142894A1
• Time in Patent Office: 1,756 Days
• Field of Search: None
• US Class Current: 623/1.34
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: Y10T 29/49799 Providing transitory integral holding or handling portion
• CPC Class Codes: Y10T 74/18392 Crank, pitman, and crank

Abstract

A method of implanting a prosthesis in a patient at a treatment site includes the steps of providing a prosthesis delivery sheath with an alignment device, loading a prosthesis into the sheath, advancing the sheath in a patient up to the treatment site, and viewing at least one of a rotational and an axial position of the alignment device at the treatment site and, if the sheath is not in a desired position, moving the sheath to the desired position based upon the position of the alignment device. The alignment device can be a pair of markers on opposing sides of a longitudinal axis of the sheath such that, when viewed from a side of the sheath, the pair forms a given shape that communicates to a user a direction in which the sheath needs to rotate minimally to align the markers and form the given shape.

Claims

1. A method of implanting a prosthesis in a patient at a treatment site, comprising the steps of:

(a) loading a prosthesis into a prosthesis delivery sheath, the prosthesis delivery sheath including an alignment device having a pair of hemispherical-shaped radiopaque markers, each marker having a contact diameter and being symmetrical about the contact diameter on opposing sides of the contact diameter, wherein the hemispherical shaped radiopaque markers are on opposite sides of the prosthesis delivery sheath along respective longitudinal axes of the prosthesis delivery sheath; and

(b) advancing the prosthesis delivery sheath in a patient to the treatment site, whereby the hemispherical-shaped radiopaque markers align to form a complete circular shape when the markers are viewed along an axis orthogonal to a major axis of the treatment site where the radiopaque markers are to be located.

2. The method according to claim 1, further comprising the step of retracting the prosthesis delivery sheath to at least partially implant the prosthesis at the treatment site.

3. The method according to claim 2, wherein the prosthesis is loaded into the prosthesis delivery system by partially compressing the prosthesis in the prosthesis delivery sheath.

4. The method according to claim 3, further comprising the steps of:

(c) providing the prosthesis delivery sheath as an inner sheath;

(d) slidably disposing the inner sheath in an outer sheath to further compress the prosthesis while the inner sheath is within the outer sheath;

(e) advancing the outer sheath containing the inner sheath in a patient towards the treatment site up to a given position at a distance from the treatment site; and

(f) while retaining the outer sheath in the given position, advancing the inner sheath out from the outer sheath to the treatment site to permit expansion of the prosthesis to the partially compressed state.

5. The method according to claim 4, further comprising the step of retracting the inner sheath to at least partially implant the prosthesis at the treatment site.

6. The method according to claim 5, further comprising the step of, upon completion of prosthesis implantation, retracting both of the inner and outer sheaths from the patient.

7. The method according to claim 6, further comprising the step of carrying out the inner and outer sheath retracting step by:

retracting the inner sheath into the outer sheath; and

subsequently retracting the outer sheath containing the inner sheath from the patient.

8. The method according to claim 4, further comprising the step of providing the inner sheath as a relatively flexible inner sheath and the outer sheath as a relatively stiff outer sheath.

9. The method according to claim 4, further comprising the step of carrying out the advancing step by advancing the outer sheath towards the treatment site only up to a point at a distance from the treatment site greater than a longitudinal length of the prosthesis.

10. The method according to claim 4, further comprising the step of carrying out the advancing step by advancing the outer sheath in vasculature of a patient towards a vascular treatment site.

11. The method according to claim 10, further comprising the step of carrying out the advancing step by advancing the outer sheath in aortic vasculature of the patient no closer to the heart than a celiac axis of the patient.

12. The method according to claim 4, further comprising the step of providing the outer sheath with a length sufficient to reach only up to a celiac axis of a patient.

13. The method according to claim 4, further comprising the step of providing the inner sheath with a prosthesis holding inner diameter at least as great as an inner diameter of the outer sheath.

14. A method of implanting a prosthesis in a patient at a treatment site, comprising the steps of:

(a) loading a prosthesis into a prosthesis delivery sheath, the prosthesis delivery sheath including an alignment device having a pair of D-shaped radiopaque markers, each marker having a contact diameter and being symmetrical about the contact diameter on opposing sides of the contact diameter, wherein the D-shaped radiopaque markers are located on opposite sides of the prosthesis delivery sheath along respective longitudinal axes of the prosthesis delivery sheath; and

(b) loading a prosthesis into the prosthesis delivery sheath;

(c) advancing the prosthesis delivery sheath in a patient to the treatment site, whereby the D-shaped markers align to form a complete ovular shape with the markers when the markers are viewed along an axis orthogonal to a major axis of the treatment site where the radiopaque markers are to be located.

15. A method of implanting a prosthesis in a patient at a treatment site, comprising the steps of:

(a) loading a prosthesis into a prosthesis delivery sheath, the prosthesis delivery sheath including an alignment device having a pair of radiopaque markers, each marker having a first shape and being connected to opposing sides of the prosthesis delivery sheath, each of the first shapes including an alignment segment, and, in a plan view of one of the markers, the alignment segments aligning with one another to, together, define a second shape different from the first shape, wherein each of the radiopaque markers has a shape selected from the group consisting of a hemisphere, a D-shape, a triangle, and an isosceles triangle; and

(b) advancing the prosthesis delivery sheath in a patient to the treatment site, whereby the radiopaque markers align to substantially form the second shape when viewed along an axis orthogonal to a major axis of the treatment site where the radiopaque markers are to be located.

16. A method of implanting a prosthesis in a patient at a treatment site, comprising the steps of:

a) loading a prosthesis into a prosthesis delivery sheath, the prosthesis delivery sheath including an alignment device having a pair of radiopaque markers on opposing sides of a longitudinal axis of the prosthesis delivery sheath, wherein the radiopaque markers each have a first shape selected from the group consisting of a hemispherical shape, a D-shape, and a triangular shape when viewed along an axis orthogonal to a major axis of the prosthesis delivery sheath;

b) advancing the prosthesis delivery sheath in the patient to the treatment site in a blood vessel; and

c) rotating the prosthesis delivery sheath until the markers substantially form a second shape when viewed along an axis orthogonal to a major axis of the treatment site where the radiopaque markers are to be located, and wherein the markers form the second shape that is a composite of two of the first shapes along complimentary sides of the first shape when the prosthesis is aligned in the blood vessel.

17. A method of implanting a prosthesis in a patient at a treatment site, comprising the steps of:

a) loading a prosthesis into a prosthesis delivery sheath, the prosthesis delivery sheath including an alignment device having a pair of radiopaque markers on opposing sides of a longitudinal axis of the prosthesis delivery sheath, wherein the radiopaque markers have a shape selected from the group consisting of;

a circle, a diamond, and an oval when viewed along an axis orthogonal to a major axis of the prosthesis delivery sheath;

b) advancing the prosthesis delivery sheath in the patient to the treatment site in a blood vessel; and

c) rotating the prosthesis delivery sheath until the markers substantially form the shape when viewed along an axis orthogonal to a major axis of the treatment site where the radiopaque markers are to be located, and wherein the markers form the shape when the prosthesis is aligned in the blood vessel.