Devices, systems, and methods for prosthesis delivery and implantation, including a prosthesis assembly

• US 7,828,838 B2
• Filed: 10/20/2005
• Issued: 11/09/2010
• Est. Priority Date: 11/28/2001
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Aptus Endosystems Inc. (Medtronic Plc)
• Inventors: Bolduc, Lee, Chiang, Andrew L.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US11/254,444
• Publication Number:
  US 20060095116A1
• Time in Patent Office: 1,846 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.13, 623/1.16, 623/1.23, 623/1.35, 623/1.36
• US Class Current: 623/1.36
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/0688 Packages or dispensers for surgical staplers
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 50/20 Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2/9517 handle assemblies therefor
• 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 2002/067 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10T 29/49947 : by applying separate fastener

Abstract

Devices, systems, and methods for implanting radially expandable prostheses in the body lumens rely on tacking or anchoring the prostheses with separately introduced fasteners. The prostheses may be self-expanding or balloon expandable, and may include a single lumen or more than one lumen. After initial placement, a fastener applier system is introduced within the expanded prostheses to deploy a plurality of fasteners to at least one prosthesis end. The fasteners are usually helical fasteners which are releasably restrained on the fastener driver, and are delivered by rotation of the fastener driver. The fasteners may be applied singly, typically in circumferentially spaced-apart patterns about the interior of at least one end of the prosthesis. A lumen extension or lumens may be coupled to the prosthesis to extend the reach of the prosthesis within the implantation site. Fasteners may also be applied to the lumen extensions.

Claims

1. A prosthesis assembly for a blood vessel or hollow body organ comprising

a main body component having a cephalad portion and a caudal portion and including a prosthetic material, the prosthetic material having an interior and comprising a main body lumen,

a main body lumen caudal stent,

a lumen extension including a prosthetic material having an interior and at least one lumen extension stent, the lumen extension being sized and configured to be telescopically fitted within the main body lumen and to increase the length of the main body lumen, and

at least one of the main body lumen caudal stent and the lumen extension stent including at least a portion having a bend extending away from the stent, the at least one bent portion engaging the other of the at least one of the main body lumen caudal stent and the lumen extension stent to prevent longitudinal migration of the lumen extension with respect to the main body component.

2. An apparatus according to claim 1

wherein the bent portion is an apex of the at least one of the main body lumen caudal stent and the lumen extension stent.

3. An apparatus according to claim 1

wherein the main body lumen caudal stent includes at least a portion having a bend extending away from the main body lumen caudal stent and the lumen extension stent includes at least a portion having a bend extending away from the lumen extension stent, the at least one bent portion of the main body lumen caudal stent engaging the at least one bent portion of the lumen extension stent to prevent longitudinal migration of the lumen extension with respect to the man body component.

4. An apparatus according to claim 1

wherein the main body component further includes a seam joining opposing surfaces of the prosthetic material together to form an internal septum extending at least a portion of the interior to form a multi-lumen flow channel, the multi-lumen flow channel comprising at least a first main body lumen and a second main body lumen, the first main body lumen and the second main body lumen sharing a portion of the internal septum.

5. An apparatus according to claim 4

further including a second main body lumen caudal stent, and

a second lumen extension including a prosthetic material having an interior and at least one second lumen extension stent, the second lumen extension being sized and configured to be telescopically fitted within the second main body lumen and to increase the length of the first main body lumen.

25. A method for deploying a prosthesis comprising

introducing a prosthesis assembly as defined in claim 1 into a targeted site comprising a blood vessel or hollow body organ,

locating the main body component of the prosthesis assembly in relation to body tissue at the targeted site,

telescopically fitting the first lumen extension of the prosthesis assembly within the first main body lumen of the main body component, and

telescopically fitting the second lumen extension of the prosthesis assembly within the second main body lumen of the main body component.

26. A method according to claim 25

further including releasing at least one main body suture loop allowing the main body component to expand at the targeted site.

27. A method according to claim 25

further including releasing at least one first lumen extension suture loop after the step of telescopically fitting the first lumen extension of the prosthesis assembly within the first main body lumen of the main body component, and

releasing at least one second lumen extension suture loop after the step of telescopically fitting the second lumen extension of the prosthesis assembly within the second main body lumen of the main body component.

28. A method according to claim 27

further including fastening the prosthesis assembly to body tissue at the targeted site.

29. A method according to claim 28

wherein fastening includes a helical fastener to fasten the prosthesis assembly to body tissue at the targeted site.

6. A prosthesis assembly for a blood vessel or hollow body organ comprising

a main body component having a cephalad portion and a caudal portion and including a prosthetic material, the prosthetic material having an interior and including a seam joining opposing surfaces of the prosthetic material together to form an internal septum extending at least a portion of the interior to form a multi-lumen flow channel, the multi-lumen flow channel comprising at least a first main body lumen and a second main body lumen with the first main body lumen extending beyond the second main body lumen, the first main body lumen and the second main body lumen sharing a portion of the internal septum,

a first main body lumen caudal stent and a second main body lumen caudal stent being staggered in position with respect to each other such that the stent in the first main body lumen do not overlap or align with the stent in the second main body lumen,

a first lumen extension including a prosthetic material and at least one first lumen extension stent, the first lumen extension being sized and configured to be telescopically fitted within the first main body lumen and to increase the length of the first main body lumen,

a second lumen extension including a prosthetic material and at least one second lumen extension stent, the second lumen extension being sized and configured to be telescopically fitted within the second main body lumen and to increase the length of the second main body lumen, and

means for coupling the first lumen extension to the first main body lumen and the second lumen extension to the second main body lumen, the means for coupling preventing longitudinal migration of the first and second lumen extensions with respect to the man body component.

7. A prosthesis assembly according to claim 6

wherein the first main body lumen includes a region that is joined by the septum to the second main body lumen and another region that is not joined by the septum to the second main body lumen and that extends beyond the second main body lumen.

8. A prosthesis assembly according to claim 6

wherein the internal septum is formed by stitching at a cephalad end of the septum and stitching at a caudal end of the septum and weaving at least a portion of the septum in-between the stitching at the cephalad end of the septum and the stitching at the caudal end of the septum.

9. A prosthesis assembly according to claim 6

wherein the means for coupling the first lumen extension to the first main body lumen and the second lumen extension to the second main body lumen comprises at least one inwardly curved cephalad apex positioned on the first main body lumen caudal stent and at least one inwardly curved cephalad apex positioned on the second main body lumen caudal stent, each inwardly curved apex engaging the related first lumen extension stent and second lumen extension stent.

10. A prosthesis assembly according to claim 6

wherein the means for coupling the first lumen extension to the first main body lumen and the second lumen extension to the second main body lumen comprises at least one outwardly curved caudal apex positioned on the first lumen extension stent and at least one outwardly curved caudal apex positioned on the second lumen extension stent, each outwardly curved apex engaging the related first main body lumen caudal stent and the second main body lumen caudal stent.

11. A prosthesis assembly according to claim 6

wherein a region of the main body component is sized and configured to receive at least one fastening element to secure the main body component to body tissue.

12. A prosthesis assembly according to claim 6

wherein the at least one first lumen extension stent includes a self-expanding stent and the second lumen extension stent includes a self-expanding stent.

13. A prosthesis assembly according to claim 6

wherein the at least one first lumen extension stent includes a spaced apart stent and the second lumen extension stent includes a spaced apart stent.

14. A prosthesis assembly according to claim 6

wherein the main body component extends along an axis, and

wherein the internal septum comprises a seam formed along the axis of the main body component.

15. A prosthesis assembly according to claim 6

wherein the main body component includes at least one suture loop coupled to the main body component, the suture loop being sized and configured to restrain the main body component during delivery to a targeted site.

16. A prosthesis assembly according to claim 6

wherein the main body component includes at least one suture loop coupled to the main body component at or near the cephalad portion and at least one suture loop coupled to the main body component at or near the caudal portion, the suture loop being sized and configured to restrain the main body component during delivery to a targeted site.

17. A prosthesis assembly according to claim 6

wherein the first lumen extension includes at least one first lumen extension suture loop coupled to the first lumen extension,

the second lumen extension includes at least one second lumen extension suture loop coupled to the second lumen extension, and

the first lumen extension suture loop being sized and configured to restrain the first lumen extension during delivery to a targeted site and the second lumen extension suture loop being sized and configured to restrain the second lumen extension during delivery to the targeted site.

18. A prosthesis assembly according to claim 6

wherein the septum is sized to be more than 5 mm in length.

19. A prosthesis assembly according to claim 6

wherein the septum is sized to be more than 10 mm in length.

20. A prosthesis assembly according to claim 6

further including at least one main body stent coupled to the prosthetic material at or near the cephalad portion of the main body.

21. A prosthesis assembly according to claim 20

wherein the at least one main body stent includes a self-expanding stent.

22. A prosthesis assembly according to claim 20

wherein the at least one main body stent includes a balloon expandable stent.

23. A prosthesis assembly according to claim 20

wherein the at least one main body stent includes spaced apart stent structures.

24. A prosthesis assembly according to claim 20

wherein the at least one main body stent includes spaced apart stents.