Aligning device for stent graft delivery system

• US 9,320,631 B2
• Filed: 01/31/2007
• Issued: 04/26/2016
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Moore, Michael, Arbefeuille, Samuel
• Primary Examiner(s): YABUT, DIANE D
• Application Number:
  US11/700,609
• Publication Number:
  US 20070135818A1
• Time in Patent Office: 3,373 Days
• Field of Search: 623/1.11, 623/1.12, 604/529
• US Class Current: 1/1
• 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) a prosthesis that is asymmetric about a major longitudinal axis;

b) a prosthesis delivery sheath in direct contact with and constraining the prosthesis for delivering the prosthesis to a treatment site; and

c) an alignment device connected to said prosthesis delivery sheath, each component of the alignment device appearing asymmetric relative to a respective axis running through a center of the component and transverse to the major longitudinal axis when viewed along the transverse axis, each component also being asymmetric relative to an axis parallel to a major longitudinal axis of the prosthesis delivery sheath, wherein said alignment device is visible to a user, thereby indicating a rotational and an axial position of the sheath with respect to the treatment site and said alignment device is a pair of markers, said markers having a contact diameter and being symmetrical about said contact diameter on opposing sides of said contact diameter.

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 2, wherein said markers are connected at opposing sides of said prosthesis delivery sheath.

4. The system according to claim 2, wherein said prosthesis delivery sheath has a proximate end and said markers are disposed at said proximate end on opposite sides thereof.

5. The system according to claim 2, wherein said markers are each hemispherical.

6. The system according to claim 5, wherein:

the contact diameter of each of said markers are on opposite sides of said prosthesis delivery sheath and aligned along respective major longitudinal axes at each of said opposite sides of said prosthesis delivery 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.

7. The system according to claim 2, wherein said markers are each D-shaped.

8. The system according to claim 7, wherein:

the contact diameters of said markers are on opposite sides of said prosthesis delivery sheath and aligned along respective major longitudinal axes at each of said opposite sides of said prosthesis delivery 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.

9. 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.

10. The system according to claim 1, further including:

a) a handle;

b) a sheath lumen slidably disposed in said handle between a retracted position and an extended position, said sheath lumen having a distal end at which said prosthesis delivery sheath is connected; and

c) an outer lumen that is stiff relative to the prosthesis delivery sheath and axially fixedly connected to said handle about said sheath lumen and said sheath.

11. The system according to claim 10, wherein:

said outer lumen has an inner diameter; and

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

12. The system according to claim 10, wherein:

said prosthesis delivery sheath has;

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

a distal prosthesis holding portion,

said tapered proximal portion guides entry of said prosthesis delivery sheath into said outer lumen when said tapered proximal portion is drawn inside an interior cavity of said 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.

13. The system according to claim 12, wherein:

said prosthesis delivery 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 prosthesis delivery sheath are formed to;

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

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

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

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

14. The system according to claim 10, wherein:

said handle has a handle axis; and

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

15. The system according to claim 14, wherein rotation of at least part of said handle about said handle axis causes a corresponding rotation of said prosthesis delivery sheath and said alignment device while said outer lumen remains substantially rotationally stable.

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

17. The system according to claim 1, wherein each one of the pair of markers is diametrically opposed.

18. The system of claim 1, wherein the prosthesis includes a longitudinal support member positioned asymmetrically about the major longitudinal axis of the prosthesis.

19. The system of claim 1, wherein the markers are D-shaped.

20. The system of claim 19, wherein the D-shaped alignment device is radiopaque.

21. A system for implanting a prosthesis, comprising:

a) a prosthesis that is asymmetric about a major longitudinal axis;

b) a prosthesis delivery sheath in direct contact with and constraining the prosthesis for delivering the prosthesis to a treatment site; and

c) an alignment device connected to said prosthesis delivery sheath, each component of the alignment device appearing asymmetric relative to a respective axis running through a center of the component and transverse to the major longitudinal axis when viewed along the transverse axis, each component also being asymmetric relative to an axis parallel to a major longitudinal axis of the prosthesis delivery sheath, wherein said alignment device is visible to a user, thereby indicating a rotational and an axial position of the sheath with respect to the treatment site and 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 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 prosthesis delivery 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. A delivery device for implanting a prosthesis, comprising:

a) a handle;

b) a prosthesis that is asymmetric about a major longitudinal axis;

c) a sheath lumen slidably disposed in said handle between a retracted position and an extended position, said sheath lumen having a distal end;

d) a prosthesis delivery sheath connected to said distal end of said sheath lumen and in direct contact with and constraining the prosthesis for delivery the prosthesis to an implantation site;

e) an outer lumen that is stiff relative to the prosthesis delivery sheath and axially fixedly connected to said handle about said sheath lumen and prosthesis delivery sheath; and

f) an alignment device connected to said prosthesis delivery sheath visible to a user, each component of the alignment device being asymmetric relative to an axis parallel to a major longitudinal axis of the prosthesis delivery sheath, each component of the alignment device also appearing asymmetric relative to a respective axis running through a center of the component and transverse to the major longitudinal axis when viewed along the transverse axis, wherein the alignment device is a pair of markers, said markers each having a contact diameter and being symmetrical about said contact diameter on opposing sides of said contact diameter, thereby indicating rotational and axial position of the prosthesis delivery sheath with respect to the implantation site.

29. The system of claim 28, wherein the prosthesis includes a longitudinal support member positioned asymmetrically about the major longitudinal axis of the prosthesis.

30. The delivery device of claim 28, wherein the markers are D-shaped.

31. The delivery device of claim 30, wherein the D-shaped alignment device is radiopaque.

32. A system for traversing a guidewire and implanting a prosthesis at an implantation site in a patient, comprising a prosthesis and a delivery device, wherein the delivery device includes:

a) a handle;

b) a prosthesis that is asymmetric about a major longitudinal axis; and

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

i) at least one guidewire lumen for slidably receiving therein the guidewire;

ii) an apex release lumen slidably disposed about said at least one guidewire lumen;

iii) a sheath lumen slidably disposed about said apex release lumen and having a distal end;

iv) a prosthesis delivery sheath that is flexible relative to the sheath lumen and connected to said distal end of said sheath lumen and disposed about said at least one guidewire lumen and said apex release lumen, said prosthesis delivery sheath in direct contact with and constraining said prosthesis therein at least prior to implantation of said prosthesis at the implantation site; and

v) an alignment device connected to said relatively flexible prosthesis delivery sheath, each component of the alignment device being asymmetric relative to an axis parallel to a major longitudinal axis of the prosthesis delivery sheath and, wherein the alignment device is visible to a user for aligning a prosthesis placed in said prosthesis delivery sheath with an implantation site both rotationally and axially, each component of the alignment device also appearing asymmetric relative to a respective axis running through a center of the component and transverse to the major longitudinal axis when viewed along the transverse axis, wherein said alignment device is a pair of markers, said markers having a contact diameter and being symmetrical about said contact diameter on opposing sides of said contact diameter; and

vi) an outer lumen that is stiff relative to the prosthesis delivery sheath and slidably disposed about said at least one guidewire lumen and said sheath lumen, and slidably disposed about said prosthesis delivery sheath when said prosthesis delivery 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.

33. The system of claim 32, wherein the prosthesis includes a longitudinal support member positioned asymmetrically about the major longitudinal axis of the prosthesis.

34. The delivery device of claim 32, wherein the markers are D-shaped.

35. The delivery device of claim 34, wherein the D-shaped alignment device is radiopaque.

36. A system for implanting a prosthesis, comprising:

a) a prosthesis that is asymmetric about a major longitudinal axis;

b) a prosthesis delivery sheath in direct contact with and constraining the prosthesis for delivering the prosthesis to a treatment site; and

c) an alignment device proximate to the prosthesis delivery sheath, each component of the alignment device being asymmetric relative to an axis parallel to a major longitudinal axis of the prosthesis delivery sheath, and wherein said alignment device is visible to a user, each component of the alignment device also appearing asymmetric relative to an axis running through a center of the component and transverse to the major longitudinal axis when viewed along the transverse axis, wherein said alignment device is a pair of markers, said markers having a contact diameter and being symmetrical about said contact diameter on opposing sides of said contact diameter, thereby indicating a rotational and an axial position of the sheath with respect to the treatment site.