Surgically anastomosable transcutaneous vascular prothesis and set comprising the same

• US 6,036,723 A
• Filed: 06/03/1998
• Issued: 03/14/2000
• Est. Priority Date: 05/02/1996
• Status: Expired due to Fees

• Current Assignee: B. Braun Celsa
• Original Assignee: B. Braun Celsa
• Inventors: Chevillon, Gerard, Anidjar, Samy
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US08/983,261
• Time in Patent Office: 650 Days
• Field of Search: 623/1, 623/12
• US Class Current: 623/1.13
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A vascular prosthesis to be implanted by the percutaneous endoluminal route is provided according to an embodiment of the invention. The vascular prosthesis includes a flexible sleeve to channel blood therein, and a tubular armature (or stent) to which the sleeve is connected essentially coaxially, the armature being capable of having a first diameter or a second diameter larger than the first, so that the prosthesis is in the form of a single tube or bifurcated tube assuming a radially constricted state for its percutaneous vascular implantation, or a radially opened out state, once it is vascularly implanted, additionally including a vascularly anastomosable terminal portion of sleeve which extends, or is added onto, the flexible sleeve, beyond the armature, this portion being therefore suitable to be anastomosed, in particular by suture, to at least one vessel or vessel substitute.

Claims

1. Vascular prosthesis (10, 60, 70) arranged to be implanted by the percutaneous endoluminal route, comprising a flexible sleeve (27, 65, 79) to channel blood therein, and a tubular armature (or stent) (29, 67, 81) to which the sleeve is connected essentially coaxially, the armature being capable of having a first diameter or a second diameter larger than the first, so that the prosthesis is in the form of a single tube (10, 60) or bifurcated tube (1, 70) assuming a radially constricted state for its percutaneous vascular implantation, or a radially opened out state, once it is vascularly implanted, characterized in that it additionally comprises a vascularly anastomosable terminal portion of sleeve (27a, 63, 71, 73) which extends, or is added onto, the said flexible sleeve, beyond the armature, this portion configured to be anastomosed, in particular by suture, to at least one vessel or vessel substitute.

3. Prosthesis according to claim 1, characterized in that it is configured to be used as a prosthesis for revascularisation in the case of a primitive iliac aneurism spreading over the hypogastric and outer iliac arteries.

4. Prosthesis according to claim 1, characterized in that the prosthesis is a bifurcated prosthesis (70) for treatment of an aneurism, comprising a principal tubular section (75) connected to secondary tubular sections (71, 73) one of which ends at its free end in the said vascularly anastomosable terminal portion of sleeve.

5. Prosthesis according to claim 4, characterized in that the free end of the principal tubular section (79) is provided with vascular fixing hooks (23, 83), while the free end of the secondary tubular sections (71, 73) is devoid of them.

6. Vascular prosthesis according to claim 1, characterized in that:

the part of the sleeve located essentially facing the armature (29, 67,

     81) is radially extensible and/or assumes its radially open tubular form only under the action of the said armature which supports it, and then exhibits its second diameter,

the anastomosable terminal portion of sleeve (27a, 63, 71,

     75) is less radially extensible than the other portion (27, 65, 79,

     27) and/or naturally assumes by itself a radially open tubular form.

7. Prosthesis according to claim 6, characterized in that the constituent materials or textures and/or the thicknesses (e₁, e₂) of the said sleeve parts, respectively facing the armature and anastomosable, are different.

8. Vascular prosthesis according to claim 6, characterized in that the anastomosable sleeve section (63, 71, 73, 75) has a capacity for deformation along the axis of the tube.

9. Prosthesis according to claim 6, characterized in that the anastomosable sleeve section does not extend, or practically does not extend, facing the armature (67, 81, 11, 29).

10. Prosthesis according to claim 1, characterized in that the anastomosable sleeve section (63;

71, 73,

     75) extends over at least the greater part of the total length (L₃, L₆ of the sleeve.

11. Prosthesis according to claim 1, characterized in that it additionally comprises:

an annular support means (105) configured to be arranged around the anastomosable terminal portion of sleeve (27a;

63, 71, 73,

     75) in order to obtain a leaktight seal with respect to the blood between the said annular means and the terminal portion,

and a leaktight fixing means (107) in order thus to fix, round the support means, the cut vessel section (51) through which the anastomosable terminal portion is passed.

12. Assembly comprising:

the vascular prosthesis to be anastomosed, according to claim 1,

and equipment (33, 39, 41, 43,

     45) for endoluminal implantation of the said prosthesis by the percutaneous route, suitable for enclosing the prosthesis when its armature or stent exhibits its first, constricted diameter, for the purpose of its percutaneous implantation, the equipment comprising for that a sheath (39,

     41) to introduce vascularly the prosthesis thus enclosed, and also an inner tube (43) configured to be inserted into the said sheath in order to play out the prosthesis vascularly from the said equipment, at the end of implantation.

13. Assembly comprising:

the vascular prosthesis to be anastomosed according to claim 1, which is in the form of a single, non-bifurcated tube (10),

another vascular prosthesis (1) for treatment of an aneurism, configured to be implanted vascularly by the percutaneous endoluminal route, and being in the form of a bifurcated tube,

and equipment for implantation of the said prostheses (1, 10, 60,

     70) by the percutaneous endoluminal route.

14. Assembly comprising:

as the first prosthesis, the vascular prosthesis according to claim 1,

and a second vascular prosthesis (1) for treatment of an aneurism, the second prosthesis, which is in the form of a bifurcated tube, itself comprising a sleeve (9) for channelling the blood and at least one tubular stent or armature (11) for its sleeve, the stent or armature being present (at 11a;

11b, 11c) at least at the two axial ends of the prosthesis (1) and having a first diameter or a second diameter larger than the first, in such a way that the second prosthesis is arranged to be implanted by the endoluminal percutaneous route,

the said two prostheses (1, 10;

60,

     70) configured to be arranged for connection between the said bifurcated second vascular prosthesis (1,

     70) and the opposite end of the said first prosthesis from that provided with the said terminal section to be anastomosed.

15. Assembly according to claim 14, characterized in that the said first and second prostheses are configured to be connected to each other by engagement with support of the armature or stent (29) of the first prosthesis inside the armature or stent (11) in question of the second prosthesis (1).

2. Vascular prosthesis for aneurism, that can be implanted by the percutaneous endoluminal route, comprising a flexible sleeve (27, 65, 79) and at least one tubular structure (29, 67, 81) forming an essentially coaxial stent or armature for the sleeve, in order to define a single or bifurcated tube, the said stent or armature assuming a first, constricted diameter for implantation by the percutaneous endoluminal route, by means of appropriate implantation equipment (33, 39, 41, 43, 45), or a second diameter larger than the first, when the prosthesis is already vascularly implanted, the prosthesis configured to be used as a prosthesis for the treatment of the spread of the said aneurism over a plurality of vessels (55, 51, 51a, 51b;

53), by vascular surgery, with anastomosis, of a vascularly anastomosable terminal portion of sleeve (27a, 63, 71,

     73) extending, or added onto, the said flexible sleeve (27, 65,

     79) with vessels or vessel substitutes.

16. An endoluminal vascular stent graft adapted to be implanted in a vascular zone of a human or animal body, the stent graft comprising:

a tubular flexible sleeve for circulating blood therein, and

at least one radially expandable tubular framework bound to the flexible sleeve and having a distal end, the framework being adapted to have a first diameter when in a radially restricted state for implanting the stent graft, and a second diameter, larger than the first diameter when the stent graft is implanted,

the flexible sleeve comprising a first portion and an extension, the extension extending beyond the distal end on the tubular framework, and having a free end that is unsupported by said tubular framework,

wherein, said extension extends sufficiently beyond the distal end on the framework to permit manipulation of the extension such that it can be chirurgically anastomosed to a wall of the vascular zone and/or a vessel substitute, by means of connecting means passing through said extension and the wall of said vascular zone and/or said vessel substitute,

and wherein the first portion of the sleeve is made of a first material and the extension is made of a second material.

17. An endoluminal vascular stent graft adapted to be implanted in a vascular zone of a human or animal body, the stent graft comprising:

a tubular flexible sleeve for circulating blood therein, and

at least one radially expandable tubular framework bound to the flexible sleeve and having a distal end, the framework being adapted to have a first diameter when in a radially restricted state for implanting the stent graft, and a second diameter, larger than the first diameter when the stent graft is implanted,

the flexible sleeve comprising an extension extending beyond the distal end on the tubular framework, said extension having a free end that is unsupported by said tubular framework and said extension extending sufficiently beyond the distal end on the framework to permit manipulation of the extension such that it can be chirurgically anastomosed to a wall of the vascular zone and/or a vessel substitute, after the tubular framework is radially expanded, by means of connecting means passing through said extension and the wall of said vascular zone and/or said vessel substitute,

an annular support means adapted to engage the sleeve extension close to the free end thereof, inside the vascular zone in which said sleeve extension is disposed, and

a leaktight fixing means for clamping the vascular zone around the annular support means without substantially crushing the sleeve extension.

18. An endoluminal vascular assembly adapted to allow a control circulation of blood in a blood vessel and configured especially for treating an aneurism, the vascular assembly comprising:

1) a first branching expandable tubular stent graft comprising;

a) a branching tubular flexible sleeve having a main portion and first and second branching portions, each portion having a free end, the first branching portion being shorter than the second branching portion, and

b) at least one expandable, tubular stent bound to the flexible sleeve, said at least one stent extending at the free ends of the main portion and of the first branching portion of the flexible sleeve, respectively,

wherein the second branching portion has a terminal length at the free end thereof, said free end and said terminal length of the second branching portion being unsupported by said at least one stent, and the terminal length being sufficiently long to permit manipulation of said terminal length of the sleeve such that it can be chirurgically anastomosed to the vascular zone and/or a vessel substitute, by means of connecting means,

2) a second expandable tubular stent graft having a first free end and a second free end, and comprising;

a) a tubular flexible sleeve adapted for circulating blood therein, and

b) at least one tubular expandable stent bound to said flexible sleeve, said at least one tubular stent being adapted to have a first diameter when in a radially restricted state for implanting the second stent graft and a second diameter, larger and the first diameter, when the second stent graft is implanted,

the flexible sleeve having a terminal length located at the first free end of the second stent graft, said terminal length and said free end that is unsupported by said at least one stent and said terminal length of the sleeve extending sufficiently beyond said at least one stent of the second stent graft to permit manipulation of the terminal length of the sleeve such that it can be chirurgically anastomosed to the vascular zone and/or a vessel substitute, by means of connecting means,

the free end of the first branching portion of the first stent graft and a second free end of the second stent graft located opposite said first free end thereof being adapted to be mutually engaged for assembling the second stent graft to the first stent graft.

19. The prosthesis assembly according to claim 18, wherein the second stent graft further comprises fixing hooks disposed at the second free end thereof.

20. The prosthesis assembly according to claim 18 wherein the connecting means comprise a suturing means passing through the terminal length of the sleeve and a wall of the vascular zone and/or the vessel substitute.

21. The prosthesis assembly according to claim 18 wherein said at least one expandable tubular stent of the first branching expandable tubular stent graft is branched.