Two-part expanding stent graft delivery system

• US 8,308,790 B2
• Filed: 02/06/2006
• Issued: 11/13/2012
• 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, Berra, Humberto A., Ouellette, Gerry
• Primary Examiner(s): DOWE, KATHERINE MARIE
• Application Number:
  US11/348,176
• Publication Number:
  US 20060129224A1
• Time in Patent Office: 2,472 Days
• Field of Search: 600/184, 623/1.11, 623/1.12, 623/1.23, 606/108
• US Class Current: 623/1.11
• 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 handle having a proximal portion and a distal portion;

a prosthesis delivery assembly including,

an guidewire catheter slidably disposed in said handle between a retracted position and an extended position, said guidewire catheter having a distal end and a tip at said distal end of said guidewire catheter,

a sheath catheter slidably disposed about said guidewire catheter and having a distal end, and

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

a relatively stiff outer catheter rotationally and longitudinally fixedly connected to a distal portion of said handle about said sheath catheter and having a proximal end and a distal end; and

a locking mechanism that selectively locks the guidewire catheter to the sheath catheter when the locking mechanism is in one position and the guidewire catheter to the outer catheter when the locking mechanism is in another position, whereby one of said sheath catheter and said outer catheter are retractable relative to the other catheter while said other catheter and said guidewire catheter remain essentially stationary relative to each other.

2. The system according to claim 1, wherein:

said handle further includes a proximal control handle having;

a handle body defining a longitudinal axis and a distal portion; and

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

said outer catheter defines an interior cavity with a cavity diameter and

the proximal end of the outer catheter is connected to said handle body to axially fix said outer catheter with respect to said distal portion of the handle body; and

wherein said prosthesis delivery assembly is movably disposed in said interior cavity of said outer catheter, 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 sheath has a tapered proximal portion fixedly connected to said distal end of said sheath catheter and a substantially cylindrical prosthesis holding portion at a distal end of said sheath.

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

5. The system according to claim 2, wherein connection between said outer catheter and said handle permits rotation of at least one of said guidewire catheter, said sheath catheter, and said prosthesis sheath when at least a portion of said handle is rotated about said axis.

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

7. The system according to claim 6, 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 catheter remains substantially rotationally stable.

8. The system according to claim 1, wherein:

said handle includes,

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 catheter to, thereby, axially fixedly and rotatably connect said outer catheter to said handle body.

9. The system according to claim 1, 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.

10. The system according to claim 1, wherein:

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

11. The system according to claim 1, wherein said sheath is tubular and is connected to said distal end of said sheath catheter about said guidewire catheter.

12. The system according to claim 1, wherein:

said guidewire catheter includes two catheters;

an inner first guidewire catheter; and

an outer second apex release catheter slidably disposed about said inner first guidewire catheter; and

said inner first guidewire catheter slidably receives therein a guidewire.

13. The system according to claim 1, wherein:

said sheath catheter has a distal opening in which said guidewire catheter is slidably disposed; and

a buttress is fixedly connected in said distal opening of said sheath catheter, said buttress;

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

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

14. The system according to claim 1, wherein:

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

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

said outer catheter 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 catheter;

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 catheter; and

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

a portion of the prosthesis disposed inside said outer catheter 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 catheter and inside said sheath being compressed to a diameter approximately equal to said sheath inner diameter.

15. The system according to claim 1, wherein said guidewire catheter is substantially stationary along said axis when said sheath and said sheath catheter are moving in a proximal direction along said axis to unsheath a prosthesis in said sheath.

16. The system according to claim 15, wherein said outer catheter is substantially stationary along said axis when said sheath and said sheath catheter are moving in a proximal direction along said axis while the prosthesis is being unsheathed.

17. The system according to claim 1, wherein:

said sheath is disposed about said guidewire catheter and has;

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

a distal prosthesis holding portion;

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

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

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

19. The system of claim 18, wherein said prosthesis is retained within said prosthesis delivery assembly slidably disposed in said handle between a retracted position and an extended position.

20. The system of claim 19, wherein said delivery system further includes:

a guidewire; and

a buttress.

21. The system according to claim 1, wherein said connection between said sheath catheter and said outer catheter permits entry of said sheath within said outer catheter.

22. The system according to claim 1, wherein said outer catheter has a length no greater than 65 cm.

23. The system of claim 22, wherein said outer catheter has a length no greater than 50 cm.

24. The system of claim 1, wherein said sheath catheter is retractable relative to said outer catheter while said outer catheter and said guidewire catheter are locked.

25. The system of claim 1, wherein said outer catheter is retractable relative to said sheath catheter while said sheath catheter and said guidewire catheter are locked.

26. The system of claim 1, wherein a distal end of the guidewire catheter is curved.

27. The system of claim 1, wherein the locking mechanism includes a locking ring.

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

a handle defining a longitudinal axis;

a prosthesis delivery assembly including a guidewire catheter slidably disposed in said handle between a retracted position and an extended position, said guidewire catheter having a distal end and a tip at said distal end of said guidewire catheter;

a sheath catheter slidably disposed about said guidewire catheter in said handle and having a distal end;

a relatively flexible prosthesis sheath connected to said distal end of said sheath catheter;

a relatively stiff outer catheter rotationally and longitudinally fixedly connected to a distal portion of said handle about said sheath catheter and said sheath; and

a locking mechanism that selectively locks the guidewire catheter to the sheath catheter when the locking mechanism is in one position and the guidewire catheter to the outer catheter when the locking mechanism is in another position, whereby one of said sheath catheter and said outer catheter are retractable relative to the other catheter while said other catheter and said guidewire catheter remain essentially stationary relative to each other;

said guidewire catheter, said sheath catheter and said sheath comprising a delivery assembly for positioning the prosthesis in the implantation site, whereby advancement or rotation of said sheath catheter and said guidewire catheter along said axis can cause rotational alignment of said sheath within a vessel to align said guidewire catheter with a portion of a vessel.

29. The system of claim 28, wherein the locking mechanism includes a locking ring.

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

a proximal control handle having,

a handle body including a proximal handle end and a distal handle end, the handle body including a major longitudinal axis,

a prosthesis movement control assembly movably disposed along the major longitudinal axis of the handle body, the prosthesis movement control assembly including a proximal handle that is restrained from rotation about the handle body, and

a distal handle at the distal handle end that is rotationally coupled to the handle body, the distal handle being restrained from axial movement along the handle body;

a prosthesis delivery assembly including,

a guidewire catheter selectively linked to the prosthesis movement control assembly and slidably disposed in said proximal control handle between a retracted position and an extended position, said guidewire catheter having a distal end and a tip at said distal end of said guidewire catheter,

a sheath catheter linked to the prosthesis movement control assembly and slidably disposed about said guidewire catheter in said proximal control handle and having a distal end, and

a relatively flexible prosthesis sheath connected to said distal end of said sheath catheter;

a relatively stiff outer catheter rotationally and longitudinally fixed to a distal portion of said distal handle and fixedly connected to said distal handle about said sheath catheter and said sheath, whereby the outer catheter rotates about the major longitudinal axis of the handle body by rotation of the distal handle about the major longitudinal axis of the handle body and whereby the prosthesis movement control assembly is rotatable within the outer catheter by rotation of the proximal handle relative to the distal handle;

a prosthesis disposed within the relatively flexible prosthesis sheath and linked to the prosthesis movement control assembly, whereby advancement or rotation of the prosthesis movement control assembly along the handle body relative to the distal handle can cause rotational alignment of the prosthesis within a vessel to align the prosthesis with an implantation site of the vessel; and

a locking mechanism that selectively locks the guidewire catheter to the sheath catheter when the locking mechanism is in one position and the guidewire catheter to the outer catheter when the locking mechanism is in another position,

wherein one of said sheath catheter and said outer catheter are retractable relative to the other catheter while said other catheter and said guidewire catheter remain essentially stationary relative to each other.

31. The system of claim 30, wherein the distal end of the guidewire catheter is curved, whereby advancement of the prosthesis movement control assembly along the handle body relative to the distal handle will cause rotational alignment of the prosthesis within a curved implantation site of the vessel to align the distal end of the guidewire catheter with the curved implantation site of the vessel.

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

a proximal control handle having a handle body including a proximal handle end and a distal handle end, the handle body including a major longitudinal axis,

a prosthesis movement control assembly movably disposed along the major longitudinal axis of the handle body, the prosthesis movement control assembly including a proximal handle that is restrained from rotation about the handle body, and

a distal handle at the distal handle end that is rotationally coupled to the handle body, the distal handle being restrained from axial movement along the handle body and having a distal portion;

a prosthesis delivery assembly including;

a guidewire catheter selectively linked to the prosthesis movement control assembly and slidably disposed in said proximal control handle between a retracted position and an extended position, said guidewire catheter having a distal end and a tip at said distal end of said guidewire catheter, and wherein the distal end of the guidewire catheter is curved,

a sheath catheter linked to the prosthesis movement control assembly and slidably disposed about said guidewire catheter in said proximal control handle and having a distal end, and

a relatively flexible prosthesis sheath connected to said distal end of said sheath catheter;

a relatively stiff outer catheter rotationally and longitudinally fixed to the distal portion said distal handle and fixedly connected to said distal handle about said sheath catheter and said sheath, whereby the outer catheter rotates about the major longitudinal axis of the handle body by rotation of the distal handle about the major longitudinal axis of the handle body and whereby advancement of the prosthesis movement assembly along the handle body relative to the distal handle will cause rotational alignment of the prosthesis within a curved implantation site of the vessel to align the distal end of the guidewire catheter with the curved implantation site of the vessel;

a prosthesis disposed within the relatively flexible prosthesis sheath and linked to the prosthesis movement control assembly, whereby advancement or rotation of the prosthesis movement control assembly along the handle body relative to the distal handle can cause rotational alignment of the prosthesis within a vessel to align the prosthesis with an implantation site of the vessel; and

a locking mechanism that selectively locks the guidewire catheter to the sheath catheter when the locking mechanism is in one position and the guidewire catheter to the outer catheter when the locking mechanism is in another position,

wherein one of said sheath catheter and said outer catheter are retractable relative to the other catheter while said other catheter and said guidewire catheter remain essentially stationary relative to each other.

33. A system for implanting a prosthesis, comprising:

a handle having a distal portion;

a prosthesis delivery assembly including;

a guidewire catheter slidably disposed in said handle between a retracted position and an extended position, said guidewire catheter having a distal end and a tip at said distal end of said guidewire catheter,

a sheath catheter slidably disposed about said guidewire catheter and having a distal end, and

a relatively flexible prosthesis sheath connected to said distal end of said guidewire catheter; and

a relatively stiff outer catheter rotationally and longitudinally fixedly connected to the distal portion of said handle about said sheath catheter and having an inner diameter smaller than a maximum outer diameter of the relatively flexible prosthesis sheath, and

a locking mechanism that selectively locks the guidewire catheter to the sheath catheter when the locking mechanism is in one position and the guidewire catheter to the outer catheter when the locking mechanism is in another position, whereby one of said sheath catheter and said outer catheter are retractable relative to the other catheter while said other catheter and said guidewire catheter remain essentially stationary relative to each other.