Aligning device for stent graft delivery system

• US 20070135818A1
• Filed: 01/31/2007
• Published: 06/14/2007
• 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 9,320,631 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• 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 prosthesis implanting system includes a delivery sheath for receiving the prosthesis and delivering it to the treatment site and an alignment device on the sheath visible to a user for indicating a rotational and an axial position of the sheath with respect to the treatment site. The alignment device is part of a delivery assembly slidably disposed in a handle. The delivery assembly has a hollow first lumen for slidably receiving therein a guidewire, a hollow second lumen slidably disposed about the first lumen, a hollow third lumen slidably disposed about the second lumen and having a distal end at which the sheath is connected and is disposed about the first and second lumen. The sheath holds the prosthesis therein prior to implantation and the alignment device is connected to the sheath. A relatively stiff outer lumen is slidably disposed about the third lumen and sheath.

Claims

1. A system for implanting a prosthesis, comprising:

a prosthesis delivery sheath for receiving the prosthesis and delivering the prosthesis to the treatment site, said sheath having an alignment device visible to a user for indicating at least one of a rotational and an axial position of the sheath with respect to the treatment site.

2. The system according to claim 1, wherein said alignment device is of a radiopaque material and is visible to the user when irradiated.

3. The system according to claim 1, wherein said alignment device is of an ultrasound-reflecting material and is visible to the user when exposed to ultrasound stimulation.

4. The system according to claim 1, further comprising:

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 at which said sheath is connected; and

a relatively stiff outer lumen axially fixedly connected to said handle about;

said inner lumen; and

said sheath when said sheath is retracted slidably inside said outer lumen.

5. The system according to claim 4, wherein:

said sheath is relatively flexible prosthesis sheath; and

said outer lumen is a relatively stiff outer lumen.

6. The system according to claim 1, further comprising a prosthesis releasably inserted in said sheath.

7. The system according to claim 1, wherein said sheath has a tapered proximal end and is tubular.

8. The system according to claim 5, wherein:

said outer lumen has an inner diameter; and

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

9. The system according to claim 5, wherein:

said outer lumen has a distal end and a length long enough to be inserted in a patient'"'"'s aorta up to a human'"'"'s celiac axis;

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

said inner lumen and said sheath distally extend away from said distal end of said outer lumen to an extended position sufficiently long enough to place said sheath in the thoracic aorta adjacent a heart.

10. The system according to claim 5, 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.

11. The system according to claim 5, wherein:

said sheath has;

a tapered proximal portion fixedly connected to said distal end of said inner 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.

12. The system according to claim 5, wherein:

said handle has a handle axis; and

connection between said outer lumen and said handle permits rotation of said inner lumen and said sheath when at least a portion of said handle is rotated about said handle axis.

13. The system according to claim 12, wherein rotation of at least part of said handle about said handle axis causes a corresponding rotation of said sheath and said alignment device while said outer lumen remains substantially rotationally stable.

14. The system according to claim 1, wherein said alignment device is a pair of radiopaque markers connected to said sheath, said markers each having a contact diameter and being symmetrical about said contact diameter on opposing sides of said contact diameter.

15. The system according to claim 14, wherein said markers are connected at opposing sides of said sheath.

16. The system according to claim 14, wherein said sheath has a proximate end and said markers are disposed at said proximate end on opposite sides thereof.

17. The system according to claim 14, wherein said markers are each hemispherical.

18. The system according to claim 17, wherein:

said markers are on opposite sides of said sheath along respective longitudinal axes of said sheath; and

an opposition of said hemispherical markers forms a complete circular shape when said markers are viewed from an orientation aligning said axes with one another.

19. The system according to claim 14, wherein said markers are each D-shaped.

20. The system according to claim 19, wherein:

said markers are on opposite sides of said sheath along respective longitudinal axes of said sheath; and

an opposition of said D-shaped markers forms a complete ovular shape with said markers when said markers are viewed from an orientation aligning said axes with one another.

21. The system according to claim 1, wherein said alignment device is a pair of radiopaque markers each having a first shape and being connected to opposing sides of said sheath, each of said first shapes including an alignment segment, and, in a plan view of one of said markers, said alignment segments aligning with one another to, together, define a second shape different from said first shape.

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

23. The system according to claim 21, wherein said sheath has a proximate end and said markers are disposed at said proximate end on opposite sides thereof.

24. The system according to claim 21, wherein said markers are each hemispherical.

25. The system according to claim 24, wherein:

said markers are on opposite sides of said sheath along respective longitudinal axes of said sheath; and

an opposition of said hemispherical markers forms a complete circular shape when said markers are viewed from an orientation aligning said axes with one another.

26. The system according to claim 21, wherein said markers are each D-shaped.

27. The system according to claim 26, wherein:

said markers are on opposite sides of said sheath along respective longitudinal axes of said sheath; and

an opposition of said D-shaped markers forms a complete ovular shape with said markers when said markers are viewed from an orientation aligning said axes with one another.

28. The system according to claim 1, wherein said alignment device is a pair of symmetrically shaped and diametrically opposed radiopaque markers connected to said sheath.

29. In a delivery system for implanting a prosthesis at a treatment site and having a sheath at the distal end of a lumen for receiving the prosthesis and delivering the prosthesis to the treatment site, an alignment device comprising:

a marker connected to the sheath and visible to a user for indicating at least one of a rotational and an axial position of the sheath with respect to the treatment site.

30. A delivery device for implanting a prosthesis, comprising:

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;

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

a relatively stiff outer lumen axially fixedly connected to said handle about;

said inner lumen; and

said sheath when said sheath is retracted slidably inside said outer lumen; and

an alignment device connected to said sheath and visible to a user for aligning a prosthesis placed in said sheath with respect to an implantation site at least one of rotationally and axially.

31. 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

an alignment device connected to said sheath and visible to a user for aligning a prosthesis placed in said sheath with respect to an implantation site at least one of rotationally and axially; and

a relatively stiff outer lumen;

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; and

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