Two-part expanding stent graft delivery system

• US 20060129224A1
• Filed: 02/06/2006
• Published: 06/15/2006
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Ouellette, Gerry, Arbefeuille, Samuel, Berra, Humberto A.
• Granted Patent: US 8,308,790 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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 delivery system for endovascularly delivering a prosthesis along a guidewire to a curved implantation site includes a delivery device having control handle and an inner lumen slidably disposed in the handle between a retracted position and an extended position. The inner lumen has a distal end and a tip at the distal end of the inner lumen. An intermediate lumen is slidably disposed about the inner lumen and has a distal end. A relatively flexible prosthesis sheath is connected to the distal end of the intermediate lumen and a relatively stiff outer lumen is axially fixedly connected to the handle about the intermediate lumen. The outer lumen has a length only long enough to be inserted in a patient'"'"'s aorta no further than the patient'"'"'s celiac axis.

Claims

1. A system for implanting a prosthesis, comprising:

a delivery device having;

a handle;

an inner lumen slidably disposed in said handle between a retracted position and an extended position, said inner lumen having a distal end and a tip at said distal end of said inner lumen;

an intermediate lumen slidably disposed about said inner lumen and having a distal end;

a relatively flexible prosthesis sheath connected to said distal end of said intermediate lumen; and

a relatively stiff outer lumen axially fixedly connected to said handle about said intermediate lumen, said outer lumen having a length only long enough to be inserted in a patient'"'"'s aorta no further than the patient'"'"'s celiac axis.

2. The system according to claim 1, wherein:

said handle is a proximal control handle having;

a handle body defining a longitudinal axis; and

a prosthesis movement control assembly movably disposed at said handle body at least along said axis;

said outer lumen defines an interior cavity with a cavity diameter and has;

a proximal end connected to said handle body to axially fix said outer lumen with respect to said handle body; and

a distal end; and

a prosthesis delivery assembly is movably disposed in said interior cavity of said outer lumen, said prosthesis delivery assembly being operatively connected to said prosthesis movement control assembly to have at least portions of said prosthesis delivery assembly selectively move in said interior cavity with said prosthesis movement control assembly when said prosthesis movement control assembly is moved with respect to said handle body.

3. The system according to claim 2, wherein:

said prosthesis delivery assembly comprises said inner lumen, said intermediate lumen, and said sheath;

said intermediate lumen is two lumen comprising;

a hollow prosthesis lumen disposed about said inner lumen, said prosthesis lumen having a distal end; and

a hollow sheath lumen slidably disposed about said prosthesis lumen, said sheath lumen having a distal end; and

said sheath is disposed about said prosthesis lumen and has;

a tapered proximal portion fixedly connected to said distal end of said sheath lumen; and

a substantially cylindrical distal prosthesis holding portion having an inner diameter no less than said cavity diameter of said outer lumen for holding the prosthesis therein at least prior to implantation of the prosthesis at the implantation site.

4. The system according to claim 3, wherein:

said sheath lumen and at least one of said inner lumen and said prosthesis lumen extend distally from said distal end of said outer lumen to an extended position; and

said sheath lumen retracts proximally when said at least one of said inner lumen and said prosthesis lumen is in said extended position.

5. The system according to claim 3, wherein said prosthesis delivery assembly is selectively fixedly connected to said prosthesis movement control assembly.

6. The system according to claim 5, wherein said prosthesis movement control assembly has a releasable locking system selectively connecting at least one of said inner lumen, said prosthesis lumen, and said sheath lumen to said prosthesis movement control assembly.

7. The system according to claim 6, wherein said releasable locking system releasably and individually connects to at least one of said inner lumen, said prosthesis lumen, and said sheath lumen to independently move at least one of said inner lumen, said prosthesis lumen, and said sheath lumen with respect to at least one other of said inner lumen, said prosthesis lumen, and said sheath lumen.

8. The system according to claim 5, wherein at least portions of said prosthesis delivery assembly are rotatably connected and axially fixedly connected to said prosthesis movement control assembly.

9. The system according to claim 1, wherein:

said handle has;

a handle body defining a longitudinal axis; and

a forward handle rotatably connected to said handle body about said axis; and

said forward handle is axially fixedly connected to said outer lumen to, thereby, axially fixedly and rotatably connect said outer lumen to said handle body.

10. The system according to claim 1, wherein said outer lumen is rotatably mounted to said handle.

11. The system according to claim 1, wherein connection between said outer lumen and said handle permits rotation of at least one of said inner lumen, said intermediate lumen, and said prosthesis sheath when at least a portion of said handle is rotated about said axis.

12. The system according to claim 2, wherein connection between said outer lumen and said handle permits rotation of said delivery assembly when at least a portion of said handle is rotated about said axis.

13. The system according to claim 12, wherein, when said delivery assembly positions the prosthesis in the implantation site, rotation of said control assembly about said axis causes a corresponding rotation of said delivery assembly in the implantation site while said outer lumen remains substantially rotationally stable.

14. The system according to claim 1, wherein said outer lumen has length no greater than a distance from the patient'"'"'s femoral arterial access site to the patient'"'"'s celiac axis.

15. The system according to claim 1, wherein:

said outer lumen has a distal end;

the implantation site is a curved portion of a human thoracic aorta; and

said inner lumen, said intermediate lumen, and said sheath distally extend away from said distal end of said outer lumen to a position in the thoracic aorta adjacent a heart.

16. The system according to claim 2, wherein:

the implantation site is a curved portion of a human thoracic aorta; and

at least portions of said prosthesis delivery assembly distally extend away from said distal end of said outer lumen to a position in the thoracic aorta adjacent a heart.

17. The system according to claim 16, wherein at least said portions of said prosthesis delivery assembly move along said axis with a corresponding movement of said control assembly along said axis when said control assembly is moved along said axis with respect to said handle body.

18. The system according to claim 1, wherein:

said inner lumen has a distal end; and

a prosthesis control device is fixedly connected to said distal end of said inner lumen and is to be releasably attached to the prosthesis when the prosthesis is loaded into said sheath.

19. The system according to claim 1, wherein said sheath is tubular and is connected to said distal end of said intermediate lumen about said inner lumen.

20. The system according to claim 1, wherein:

said outer lumen has an inner diameter; and

said sheath has a prosthesis holding diameter no less than said inner diameter.

21. The system according to claim 1, wherein:

said inner lumen is two lumen including;

an inner first lumen; and

an outer second lumen slidably disposed about said inner first lumen; and

said inner first lumen slidably receives therein a guidewire.

22. The system according to claim 21, wherein said intermediate lumen and said inner first lumen are axially fixed with respect to one another and said outer second lumen is slidably disposed between said intermediate lumen and said inner first lumen.

23. The system according to claim 1, wherein:

said intermediate lumen has a distal opening in which said inner lumen is slidably disposed; and

a buttress is fixedly connected in said distal opening of said intermediate lumen, said buttress;

defining an inner bore in which said inner lumen is slidably disposed; and

forming a proximal stop for the prosthesis when the prosthesis is compressed inside said sheath and said outer lumen.

24. The system according to claim 1, wherein:

said sheath defines a sheath interior with a sheath inner diameter;

said outer lumen defines an interior cavity with a cavity diameter; and

said outer lumen and said sheath are formed to;

compress the prosthesis inside said sheath to a first diameter approximately equal to said cavity diameter and smaller than said sheath inner diameter when said sheath is inside said outer lumen;

compress the prosthesis inside said sheath to approximately said sheath inner diameter when the prosthesis holding portion of said sheath is outside said interior cavity of said outer lumen; and

compress the prosthesis in two ways when the prosthesis holding portion of said sheath is partially inside said outer lumen;

a portion of the prosthesis disposed inside said outer lumen and said sheath being compressed to a diameter approximately equal to said cavity diameter; and

a portion of the prosthesis disposed outside said interior cavity of said outer lumen and inside said sheath being compressed to a diameter approximately equal to said sheath inner diameter.

25. The system according to claim 3, wherein the prosthesis lumen is substantially stationary along said axis when said sheath and said sheath lumen are moving in a proximal direction along said axis to unsheath a prosthesis in said sheath.

26. The system according to claim 1, wherein said inner lumen is substantially stationary along said axis when said sheath and said intermediate lumen are moving in a proximal direction along said axis to unsheath a prosthesis in said sheath.

27. The system according to claim 26, wherein said outer lumen is substantially stationary along said axis when said sheath and said intermediate lumen are moving in a proximal direction along said axis while the prosthesis is being unsheathed.

28. The system according to claim 3, wherein the prosthesis lumen, said inner lumen, and said outer lumen are substantially stationary along said axis when said sheath and said sheath lumen are moving in a proximal direction along said axis to unsheath a prosthesis in said sheath.

29. The system according to claim 1, wherein:

said sheath is disposed about said inner lumen and has;

a tapered proximal portion fixedly connected to said distal end of said intermediate lumen; and

a distal prosthesis holding portion;

said tapered proximal portion guides entry of said sheath into said outer lumen when said tapered proximal portion is drawn inside said interior cavity of said hollow outer lumen; and

said outer lumen radially collapses said distal prosthesis holding portion when said distal prosthesis holding portion is drawn inside said outer lumen.

30. The system according to claim 1, further comprising a prosthesis.

31. The system according to claim 1, wherein said connection between said intermediate lumen and said outer lumen permits entry of said sheath within said outer lumen.

32. The system according to claim 1, wherein said outer lumen has a length no greater than a distance from a patient'"'"'s femoral arterial access site to the patient'"'"'s celiac axis.

33. A system for implanting a prosthesis in a patient at an implantation site, comprising:

a delivery device having;

a handle defining a longitudinal axis;

an inner lumen slidably disposed in said handle between a retracted position and an extended position, said inner lumen having a distal end and a tip at said distal end of said inner lumen;

an intermediate lumen slidably disposed about said inner lumen in said handle and having a distal end;

a relatively flexible prosthesis sheath connected to said distal end of said intermediate lumen; and

a relatively stiff outer lumen axially fixedly connected to said handle about said intermediate lumen and said sheath, said outer lumen having a length only long enough to be inserted in the patient'"'"'s aorta no further than the patient'"'"'s celiac axis;

said inner lumen, said intermediate lumen and said sheath comprising a delivery assembly for positioning the prosthesis in the implantation site; and

when said delivery assembly positions the prosthesis in the implantation site, rotation of a portion of said handle about said longitudinal axis causes a corresponding rotation of said delivery assembly in the implantation site while said outer lumen remains substantially rotationally stable.

34. A system for traversing a guidewire and implanting a prosthesis at an implantation site in a patient, comprising:

a prosthesis; and

a delivery device having;

a handle;

a prosthesis delivery assembly slidably disposed in said handle between a retracted position and an extended position, said delivery assembly having;

at least one hollow first lumen for slidably receiving therein the guidewire;

a hollow second lumen slidably disposed about said at least one first lumen;

a hollow third lumen slidably disposed about said second lumen and having a distal end;

a relatively flexible hollow prosthesis sheath connected to said distal end of said third lumen and disposed about said at least one first lumen and said second lumen, said sheath holding said prosthesis therein at least prior to implantation of said prosthesis at the implantation site; and

a relatively stiff outer lumen;

having a length only long enough to be inserted in a patient'"'"'s aorta no further than the patient'"'"'s celiac axis;

slidably disposed about said at least one first lumen, and said third lumen and slidably disposed about said sheath when said sheath is at least partially inside said outer lumen;

having a proximal end connected to said handle to axially fix said outer lumen with respect to said control handle.

35. The system according to claim 34, wherein:

said outer lumen has a distal end; and

said prosthesis delivery assembly is releasably connected to said handle to have at least portions of said prosthesis delivery assembly selectively extend distally out of and back into said outer lumen where;

said third lumen and at least one of said first lumen and said second lumen extend distally from said distal end of said outer lumen to an extended position; and

said third lumen retracts proximally when said at least one of said first lumen and said second lumen is in said extended position.

36. A prosthesis implantation system, comprising:

a prosthesis; and

a delivery device having;

a handle;

an inner lumen slidably disposed in said handle between a retracted position and an extended position, said inner lumen having a distal end and a tip at said distal end of said inner lumen;

an intermediate lumen slidably disposed about said inner lumen in said handle and having a distal end;

a relatively flexible prosthesis sheath connected to said distal end of said intermediate lumen; and

a relatively stiff outer lumen axially fixedly connected to said handle about said intermediate lumen, said outer lumen having a length no greater than 65 cm.

37. A system for implanting a prosthesis, comprising:

a delivery device having;

a handle;

at least one inner lumen slidably disposed in said handle between a retracted position and an extended position, said inner lumen having a distal end and a tip at said distal end of said inner lumen;

at least one intermediate lumen slidably disposed about said inner lumen in said handle and having a distal end;

a relatively flexible prosthesis sheath connected to said distal end of said intermediate lumen; and

a relatively stiff outer lumen axially fixedly connected to said handle about said intermediate lumen, said outer lumen having a length only long enough to be inserted in a patient'"'"'s aorta no further than the patient'"'"'s celiac axis;

said sheath lumen, said inner lumen, and said prosthesis lumen extend distally from said distal end of said outer lumen to an extended position; and

said sheath lumen retracts proximally when at least one of said inner lumen and said intermediate lumen is in said extended position.

38. The system according to claim 37, wherein:

said at least one inner lumen is two inner lumen; and

said at least one intermediate lumen is two lumen comprising;

a hollow prosthesis lumen disposed about said inner lumen, said prosthesis lumen having a distal end; and

a hollow sheath lumen slidably disposed about said prosthesis lumen, said sheath lumen having a distal end.