Endoluminal device having enhanced affixation characteristics

• US 7,025,779 B2
• Filed: 02/26/2003
• Issued: 04/11/2006
• Est. Priority Date: 02/26/2003
• Status: Expired due to Fees

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Elliott, Christopher J.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US10/374,854
• Publication Number:
  US 20040167605A1
• Time in Patent Office: 1,140 Days
• Field of Search: 623 115- 122, 623/1.35, 623/1.3
• US Class Current: 623/1.35
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An endoluminal device for affixation to a wall of a body lumen having a neck region defined by a relatively narrow width and a shoulder region that diverges from the neck region to a relatively wider width. The device comprises a shoulder portion, which may be part of a bulbous portion, having a diameter profile that conforms to the shoulder region, and, in some embodiments, a plurality of affixation members in an area of the device that typically extends from a distal end of the device through the shoulder portion. In one embodiment, the device comprises an endograft for repair of an aneurysm, such as an abdominal aortic aneurysm (AAA). Methods of using the endograft to inhibit continued diametric expansion of the aneurysm and to inhibit endoleak formation and migration of the endograft are also described.

Claims

1. A method of inhibiting diametric expansion of an aneurysm having a lumen wall, the aneurysm having an aneurysm neck region at one end having a width and a shoulder region adjacent the neck region having a diverging width greater than the width of the aneurysm neck region, the method comprising deploying an endograft in the aneurysm, the endograft having an endograft neck with a diameter approximately equal to the width of the aneurysm neck region and a shoulder portion having a device diameter profile that conforms to a lumen diameter profile of the shoulder region of the aneurysm, wherein the shoulder portion comprises part of a bulbous portion, and the endograft neck is located adjacent the bulbous portion, wherein the bulbous portion has a length characterized by a diverging and converging diameter greater than the endograft neck diameter along the bulbous portion length, the endograft having a diameter profile in said converging diameter part of said bulbous portion length that does not conform to the body lumen diameter profile, the endograft neck and the shoulder portion comprising a plurality of affixation members for affixing to the lumen wall of the aneurysm.

2. A method of inhibiting endoleak formation and migration of an endograft deployed in a lumen having a lumen wall, a lumen neck region having a lumen neck width, and a lumen shoulder region adjacent the lumen neck region having a diverging width greater than the lumen neck region width, the method comprising:

providing the endograft with an endograft neck having a diameter approximately equal to the lumen neck region diameter and a shoulder portion adapted to match the diverging width of the lumen shoulder region, wherein the shoulder portion comprises part of a bulbous portion, and the endograft neck is located adjacent the bulbous portion, wherein the bulbous portion has a length characterized by a diverging and converging diameter greater than the endograft neck diameter along the bulbous portion length, the endograft having a diameter profile in said converging diameter part of said bulbous portion length that does not conform to the body lumen diameter profile.

3. The method of claim 2 further comprising providing the endograft neck and the shoulder portion with a plurality of affixation members for affixing to the lumen wall.

4. A method of repairing a body lumen having a lumen wall, a lumen neck region having a lumen neck width, and a lumen shoulder region proximal the lumen neck region having a diverging width greater than the lumen neck region width, the method comprising the steps of:

(a) providing an endograft having an expanded configuration and a compressed configuration, the endograft comprising in the expanded configuration an endograft neck with a diameter approximately equal to the lumen neck region width and a bulbous portion having a shoulder portion adapted to match the diverging width of the lumen shoulder region, wherein the bulbous portion has a length characterized by a diverging and converging diameter greater than the endograft neck diameter along the bulbous portion length, the endograft having a diameter profile in said converging diameter part of said bulbous portion length that does not conform to the body lumen diameter profile; and

the endograft comprising a plurality of affixation members for affixing to the lumen wall, the affixation members disposed along an axial region of the endograft including at least the endograft neck and the shoulder portion of the bulbous portion;

(b) constraining the endograft in the compressed configuration for introduction into the body lumen;

(c) advancing the endograft to a deployment location; and

(d) deploying the endograft so that the endograft shoulder portion is aligned with the lumen shoulder region and one or more of the affixation members in the endograft neck affix to the lumen neck region and one or more of the affixation members in the endograft shoulder portion affix to at least a portion of the lumen shoulder region.

5. The method of claim 4, wherein the method comprises repairing an aneurysm.

6. The method of claim 4, wherein the method comprises repairing an abdominal aortic aneurysm.

7. The method of claim 5, wherein the endograft comprises a self-expanding stent having at least a partial covering or lining of a graft material, the step of deploying the endograft comprising releasing the endograft from a radial constraint that confines it in the compressed configuration so that the self-expanding stent self-expands from the compressed configuration to the expanded configuration.

8. The method of claim 7, wherein, after deploying the stent, the stent exerts a radial expansion force against the lumen wall, wherein the radial expansion force exerted by the endograft neck is greater than the radial expansion force exerted by the bulbous portion.

9. The method of claim 7, wherein the endograft comprises a combination self-expanding/plastically-deformable stent and the step of deploying the endograft further comprising, after the self-expansion of the stent, modeling the stent the conform the stent to the lumen wall.

10. A method of repairing an abdominal aortic aneurysm (AAA) in a body lumen having a lumen wall, the body lumen having, at a distal end of the AAA, a renal neck region, defined by a relatively narrow width, and a renal shoulder region that diverges from the renal neck region;

and, at a proximal end of the AAA, one or more iliac neck regions defined by a relatively narrow width, and one or more iliac shoulder regions, each of which diverges from the corresponding iliac neck region, the method comprising the steps of;

(a) providing an endograft having an expanded configuration and a compressed configuration, the endograft comprising a modular device having a first modular component comprising a distal bulbous region and one or more additional modular components each comprising a proximal bulbous region, wherein, in the expanded configuration, the endograft comprises (i) a first endograft neck with a diameter approximately equal to the renal neck region width with the distal bulbous portion having at least a shoulder portion adapted to match the diverging width of the renal shoulder region, the distal bulbous portion having a length characterized by a diverging and converging diameter greater than the first endograft neck diameter along the bulbous portion length, the endograft having a diameter profile in said converging diameter part of said distal bulbous portion length that does not conform to the body lumen diameter profile, and (ii) an additional endograft neck with a diameter approximately equal to the iliac neck region width with the proximal bulbous portion having at least a shoulder portion adapted to match the diverging width of the iliac shoulder region, the proximal bulbous portion having a length characterized by a diverging and converging diameter greater than the additional endograft neck diameter along the bulbous portion length, the endograft having a diameter profile in said converging diameter part of said proximal bulbous portion length that does not conform to the body lumen diameter profile; and

the endograft comprises a plurality of affixation members for affixing to the lumen wall, the affixation members disposed along an axial region of the endograft including at least the first and additional endograft necks and the shoulder portion of the distal bulbous portion and the shoulder portion of the proximal bulbous portion;

(b) constraining the endograft in the compressed configuration for introduction into the body lumen;

(c) advancing the endograft to a deployment location;

(d) deploying the first modular component of the endograft so that the shoulder portion of the distal bulbous portion is aligned with the renal shoulder region and one or more of the affixation members in the first endograft neck affix to the renal neck region and one or more of the affixation members in the distal bulbous portion affix to at least a portion of the renal shoulder region; and

(e) then deploying the one or more additional modular components of the endograft so that the shoulder portion of each proximal bulbous portion is aligned with a corresponding iliac shoulder region and one or more of the affixation members in each additional endograft neck affix to the corresponding iliac neck region and one or more of the affixation members in each proximal bulbous portion affix to at least a portion of the corresponding iliac shoulder region, each of the one or more additional modular components mating with the first modular component such that a distal end of each additional modular component connects to a proximal end of the first modular component.

11. The method of claim 10, comprising reverse-deploying the one or more additional modular components.