Method for aligning a stent graft delivery system

• US 20070142894A1
• Filed: 01/31/2007
• Published: 06/21/2007
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Arbefeuille, Samuel, Moore, Michael
• Granted Patent: US 8,062,349 B2
• Time in Patent Office: Days
• US Class Current: 623/1.120
• 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, which comprises:

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.

2. The method according to claim 1, which further comprises retracting the sheath to at least partially implant the prosthesis at the treatment site.

3. The method according to claim 2, which further comprises carrying out the loading step by partially compressing the prosthesis in the sheath.

4. The method according to claim 3, which further comprises:

providing the prosthesis delivery sheath as an inner sheath;

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

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

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, which further comprises retracting the inner sheath to at least partially implant the prosthesis at the treatment site.

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

7. The method according to claim 4, which further comprises providing the inner sheath as a relatively flexible inner sheath and the outer sheath as a relatively stiff outer sheath.

8. The method according to claim 4, which further comprises 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.

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

10. The method according to claim 9, which further comprises 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.

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

12. The method according to claim 6, which further comprises 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.

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

14. The method according to claim 1, which further comprises providing the alignment device as a pair of radiopaque markers each having a contact diameter and being symmetrical about the contact diameter on opposing sides of the contact diameter.

15. The method according to claim 14, which further comprises connecting the markers at opposing sides of the sheath.

16. The method according to claim 14, which further comprises:

providing the sheath as a tubular sheath having a proximate end; and

placing the markers at the proximate end on opposite sides thereof.

17. The method according to claim 14, which further comprises providing the markers in a hemispherical shape.

18. The method according to claim 17, which further comprises placing the markers on opposite sides of the sheath along respective longitudinal axes of the sheath, opposition of the hemispherical markers forming a complete circular shape when the markers are viewed from an orientation aligning the axes with one another.

19. The method according to claim 14, wherein the markers are each D-shaped.

20. The method according to claim 19, which further comprises placing the markers on opposite sides of the sheath along respective longitudinal axes of the sheath, opposition of the D-shaped markers forming a complete ovular shape with the markers when the markers are viewed from an orientation aligning the axes with one another.

21. The method according to claim 1, which further comprises providing the alignment device as a pair of radiopaque markers each having a first shape and being connected to opposing sides of the 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.

22. The method according to claim 21, wherein the second shape is symmetrical about the alignment segment.

23. The method according to claim 21, wherein the markers each have a shape selected from the group consisting of a hemisphere, a D-shape, a triangle, and an isosceles triangle.

24. The method according to claim 1, which further comprises providing the alignment device as a pair of symmetrically shaped and diametrically opposed radiopaque markers connected to the sheath.

25. The method according to claim 1, which further comprises:

providing the alignment device as a pair of radiopaque markers on opposing sides of a longitudinal axis of the sheath such that, when viewed from a side of the sheath, the markers together form a given shape;

carrying out the advancing step by advancing the sheath in a blood vessel while viewing the alignment device; and

aligning the sheath in a given orientation by rotating the sheath along the longitudinal axis until the viewed markers substantially form the given shape.

26. The method according to claim 25, which further comprises forming the markers each with a shape having a contact segment, the shape being symmetrical, when the two contact segments are aligned with one another, about the aligned contact segments.

27. The method according to claim 25, which further comprises:

shaping each of the markers with an alignment segment; and

aligning the alignment segments with one another to form the given shape when viewed in a plan view of one of the markers.

28. The method according to claim 25, which further comprises selecting the given shape to communicate to a user a direction in which the sheath needs to rotate minimally to align the markers in the given shape.

29. The method according to claim 28, which further comprises:

providing each of the markers with a shape selected from the group consisting of a hemispherical shape, a D-shape, and a triangular shape; and

indicating the direction for minimal rotation with two flat diameters of the shape and two highest points of opposing curves of the shape.

30. The method according to claim 25, wherein the given shape is one of a circle, a diamond, and an oval.

31. The method according to claim 25, which further comprises providing each of the markers in a shape selected from at least one a group consisting of a hemisphere, a D-shape, a triangle, and an isosceles triangle.

32. A method of implanting a prosthesis in a patient at a treatment site, which comprises:

providing a prosthesis delivery sheath having an alignment device;

loading a prosthesis into the sheath;

advancing the sheath in a patient up to the treatment site; and

viewing the rotational position of the alignment device at the treatment site and, if the sheath is not in a rotationally desired position, rotating the sheath to the desired position.

33. The method according to claim 32, which further comprises viewing the axial position of the alignment device at the treatment site and, if the sheath is not in an axially desired position, one of extending and retracting the sheath to the desired axial position.

34. The method according to claim 32, which further comprises:

providing the alignment device as 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 of markers together form 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;

carrying out the advancing step by advancing the sheath while viewing the alignment device; and

aligning the sheath in a given orientation by rotating the sheath along the longitudinal axis until the viewed markers substantially form the given shape.

35. A method of implanting a prosthesis in a patient at a treatment site, which comprises:

providing a prosthesis delivery sheath having an alignment device;

loading a prosthesis into the sheath;

advancing the sheath in a patient up to the treatment site; and

viewing the axial position of the alignment device at the treatment site and, if the sheath is not in an axially desired position, one of extending and retracting the sheath to the desired axial position.

36. The method according to claim 35, which further comprises viewing the rotational position of the alignment device at the treatment site and, if the sheath is not in a rotationally desired position, rotating the sheath to the desired position.

37. The method according to claim 35, which further comprises:

providing the alignment device as 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 of markers together form 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;

carrying out the advancing step by advancing the sheath while viewing the alignment device; and

aligning the sheath in a given orientation by rotating the sheath along the longitudinal axis until the viewed markers substantially form the given shape.

38. A method of implanting a prosthesis in a patient at a treatment site, which comprises:

providing a prosthesis delivery system with a relatively flexible inner sheath and a relatively stiff outer sheath;

providing the inner sheath with an alignment device;

loading a prosthesis inside the inner sheath;

loading the inner sheath containing the prosthesis within the outer sheath;

advancing the outer sheath in a patient towards the treatment site up to a given position at a distance from the treatment site;

while retaining the outer sheath in the given position;

advancing the inner sheath out from the outer sheath to the treatment site;

viewing the axially position of the alignment device at the treatment site and, if the inner sheath is not in an axially desired position, one of advancing and retracting the inner sheath to the desired position;

viewing the rotational position of the alignment device at the treatment site and, if the inner sheath is not in a rotationally desired position, rotating the inner sheath to the desired position; and

retracting the inner sheath to at least partially implant the prosthesis at the treatment site; and

upon completion of prosthesis implantation, retracting both of the inner and outer sheaths from the patient.

39. The method according to claim 38, which further comprises:

carrying out the first advancing step by threading the inner and outer sheaths onto a guidewire and into a patient to place the outer sheath into an aorta of the patient only up to a point at a distance from the treatment site greater than a length of the prosthesis; and

carrying out the second advancing step by advancing the inner sheath distally out of the outer catheter in the aorta towards the patient'"'"'s heart to transport the prosthesis further upstream into the aorta.

40. The method according to claim 39, which further comprises carrying out the advancing step by advancing the inner sheath distally out of the outer sheath and into a curved thoracic aorta.

41. The method according to claim 38, which further comprises:

providing the alignment device as a pair of markers on opposing sides of a longitudinal axis of the inner sheath such that, when viewed from a side of the inner sheath, the pair of markers together form a given shape that communicates to a user a direction in which the inner sheath needs to rotate minimally to align the markers and form the given shape;

carrying out the inner sheath advancing step by advancing the inner sheath while viewing the alignment device; and

carrying out the inner sheath rotating step by viewing the rotational position of the alignment device at the treatment site and, if the inner sheath is not in a rotationally desired position,

rotating the inner sheath along the longitudinal axis until the viewed markers substantially form the given shape.