Graft for treating the distal aortic arch and descending aorta in type a patients
A prosthetic graft assembly ( 40, 120 ) is disclosed for placement of a patient's aortic arch and repair of the descending aorta in a procedure which requires only a sternotomy. The assembly includes a descending graft element ( 40 ) which includes an eversible cuff ( 52 ) which can be wrapped over a cut end ( 26 ) of the descending aorta ( 18 ). Distal perfusion can be re-established prior to aortic arch replacement. A second prosthetic element ( 120 ), optimised to the patient, is fitted with a replacement for the aortic arch and attached to the descending aorta graft ( 40 ). An introducer assembly ( 30 ) having a transparent or translucent sheath ( 70 ) enables the descending aortic graft element ( 40 ) to be deployed without the use of x-rays.
1. A graft assembly comprising:
a unitary tubular graft element having a length, a first end, a second end and an axis;
a plurality of stent elements extending along a majority of the length of the tubular graft element from the first end thereof, to provide a stented first portion of the tubular graft element:
the tubular graft element from an end of the first stented portion to the second end of the graft element being free of stents and forming a non-stented second portion at the second end of the tubular graft element;
wherein the non-stented second portion is a minor portion of the length of the tubular graft element;
the second portion having a circumference at least as large as a circumference of the first portion so that the second end of the tubular graft element is eversible over the first portion to form a coaxially overlapping cuff to the tubular graft.
2. A graft assembly according to claim 1 , wherein the second portion of the tubular graft element has a length at least one of 20 to 40 millimetres.
3. A graft assembly according to claim 1 , wherein the first portion of the tubular graft element has a length of 10 to 20 centimetres.
4. A graft assembly according to claim 1 , wherein the tubular graft element has a single lumen.
5. A graft assembly according to claim 1 , wherein the tubular graft element has a substantially cylindrical form.
6. A graft assembly according to claim 1 , wherein the first and second portions of the tubular graft element have substantially the same open diameter.
7. A graft assembly according to claim 1 , for use in the treatment of the descending aorta, wherein the second end of the tubular graft element is eversible over a transversally severed aorta wall.
8. A graft assembly according to claim 1 , including a second graft section configured to be sutured to the tubular graft element, wherein the second graft section is formed to fit to the aortic arch of a patient.
9. An introducer system comprising:
a medical device carrier, a graft assembly fitted on the device carrier in a radially compressed state, and a sheath fitted over the graft assembly;
wherein the graft assembly comprises a unitary tubular graft element having a length, a first end, a second end and an axis;
a plurality of stent elements extending along a majority of the length of the tubular graft element from the first end thereof, to provide a stented first portion of the tubular graft element;
the tubular graft element from an end of the first stented portion to the second end of the graft element being free of stents and forming a non-stented second portion at the second end of the tubular graft element;
wherein the non-stented second portion is a minor portion of the length of the tubular graft element;
the second portion having a circumference at least as large as a circumference of the first portion so that the second end of the tubular graft element is eversible over the first portion to form a coaxially overlapping cuff to the tubular graft; and
wherein at least a portion of the sheath overlying the graft assembly is transparent or translucent.
10. An introducer system according to claim 9 , wherein the medical device carrier includes a proximal end and a distal end, an introducer tip being present at the distal end; the graft assembly being carried on the device carrier with the stented first graft portion thereof disposed facing the distal end and the non-stented second portion being disposed proximally thereto.
11. An introducer system according to claim 9 , wherein the entire length of the sheath is transparent or translucent.
12. An introducer system according to claim 10 , wherein the sheath is made from a transparent or translucent plastics material.
13. An introducer system according to claim 12 , wherein the sheath is made from polytetrafluoroethylene.
14. An introducer system according to claim 9 , wherein the sheath is splittable.
15. An introducer system according to claim 13 , wherein the second portion of the tubular graft element has a length at least one of 20 to 40 millimetres.
16. An introducer system according to claim 15 , wherein the first portion of the tubular graft element has a length of 10 to 20 centimetres.
17. An introducer system according to claim 9 , wherein the tubular graft element has a single lumen.
18. An introducer system according to claim 9 , wherein the first and second portions of the tubular graft element have substantially the same open diameter.
19. An introducer system according to claim 9 , wherein the tubular graft element is formed of a fabric of polyethylene terephthalate, polytetrafluoroethylene (PTFE) or polyester.
20. A method of treating aortic disease including the steps of:
opening a patient's aorta at or proximate the aortic arch;
cutting transversally the descending aorta proximate the aortic arch;
disposing into the descending aorta a unitary tubular graft element having:
a length, a first end, a second end and an axis;
a plurality of stent elements extending along a majority of the length of the tubular graft element from the first end thereof, to provide a stented first portion of the tubular graft element;
the tubular graft element from an end of the first stented portion to the second end of the graft element being free of stents and forming a non-stented second portion at the second end of the tubular graft element;
wherein the non-stented second portion is a minor portion of the length of the tubular graft element;
the second portion having a circumference at least as large as a circumference of the first portion;
everting the second end of the tubular graft element over the transversally severed aorta wall, thereby to form a cuff to the tubular graft element, the cuff overlapping the aorta wall and the first portion of the tubular graft element; and
suturing a second graft element to the tubular graft element, wherein the second graft element is formed to fit to the aortic arch of a patient.