# Patent

## Title
Arterial graft device

## Abstract

An arterial graft device and a process for positioning the same, wherein the device provides a first part positioned by conventional techniques within the artery, and a second part which is positioned and fixed on the first part by a segment which is provided on the first part so as to prevent a catheter guidewire—whereby the second part is positioned in place—from deviating and damaging arterial walls.

## Background
This application is a continuation of U.S. application Ser. No. 08/822,858, filed Mar. 24, 1997, now U.S. Pat. No. 6,302,908.


FIELD OF THE INVENTION
This invention refers to techniques for the treatment of aneurysm and preferably to the endoluminal treatment thereof, and more particularly, this invention refers to an arterial graft device and a method for positioning the same. More specifically, this invention refers to an aortic bifurcated endoluminal graft device used in the treatment of infra-renal aortic aneurysm, as well as to a process for positioning such device within the infra-renal aorta and the corresponding iliac arteries.
BACKGROUND OF THE INVENTION
In the field of vascular therapies, the endoluminal treatment of aneurysm is being increasingly implemented, together with the treatment of other occlusive diseases and trauma of arteries. In the particular case of infra-renal aortic aneurysm, a bifurcated graft device is currently used, which comprises at least a stump of the kind comprising a deployable and expandable metal material which is disposed at the level of the infra-renal aorta, including both iliac common arteries. In order to carry out this treatment, a double-system graft device, which basically consists of two components or parts. The first part is an aortic main tubular body aimed at endoluminally covering the infra-renal aorta, and which goes through an extension or segment that is to be coupled to one of the iliac arteries. Once this first part or component of the graft device has been positioned by the already known catheterizing techniques, the second part of the device has to be connected, which is formed by a contralateral segment to be connected to a connecting opening of the first part of the device. The contralateral segment will be received within the connecting opening of the said first part of the device and will enter said connecting opening through the guidewire of a catheter directed from the femoral artery of the patient up to the aortic aneurysm cavity. Once there, the second component of the graft device will be carefully and properly connected to the connecting opening of the first component of the said graft device.
Inserting the guidewire and guiding it until the same enters the connecting opening of the graft first component is the most difficult step, since the end of the catheter guide, once inside the aneurysm cavity, lacks any guide leading it directly towards the said connecting opening. When the professional tries to find the connecting opening so as to introduce the distal end of the catheter wire, this end can possibly penetrate the aortic mural thrombus—present in the aneurysm cavity—and can eventually cause disruption of the thrombus and embolism of the visceral arteries and of the lower extremity arteries.
In order to prevent such accidents during a treatment of aneurysm consisting in positioning an endoluminal graft, the inventor has sought a solution through the possibility of safely directing the guidewire of the catheter up to the connecting opening of the graft first component, as well as directing the said second component and having it easily connected to the first component through the corresponding connecting opening.
SUMMARY OF THE INVENTION
Therefore, it is an object of the present invention to provide an arterial graft device, which is formed by two components safely coupled one to the other once the first component is positioned within the artery to be treated, said device comprising guiding means for a guidewire of a catheter and for the second component to be coupled to the connecting opening of the first component.
Further, it is an object of this invention to provide an arterial graft device of the type comprising two parts to be inserted one at a time within the artery to be repaired and which should be connected one to the other within the artery they enter by means of catheterizing techniques, wherein a first of said parts has a connecting opening where the second part is coupled, said first part comprising guiding means which form a funnel allowing entrance of the catheter guidewire and of the second part of said graft device.
It is yet a further object of this invention to provide a process for positioning an arterial graft device at the place where said first part of the device is inserted and positioned within the artery to be repaired, a catheter guidewire being then inserted therein and said second part of the graft device being thereby carried to the connecting opening so as to be connected to the first part of the graft device, wherein said guidewire is directed towards the artery to be repaired and, when reaching said artery, it is funneled through a coned passage that becomes narrower at the portion thereof near said connecting opening, wherein said second part of the graft device is carried along said guidewire and along said funnel until being connected to said connecting opening of the first part of the graft device.



BRIEF DESCRIPTION OF THE DRAWINGS
For the sake of more clearly understanding the object of this invention, the same has been illustrated by several figures, which represent some of the preferred embodiments of said object, as an example, and, wherein:
FIG. 1 is a schematic view of the aorta wherein, and by means of conventional techniques, a first component of a graft device has been positioned, said first component having a main part disposed at the infra-renal aortic area and a lower segment inserted within one of the iliac arteries.
FIG. 2 is a view similar to that of FIG. 1, which shows the end of a guidewire damaging the aortic wall when trying to insert such guidewire within the connecting opening of the first component of said graft device.
FIG. 3 is an illustration similar to that of FIGS. 1 and 2, which shows the second component of the graft device already connected to the first component of the said device, which is also carried out by a conventional process.
FIG. 4 is a view similar to that of FIGS. 1 to 3 , which further shows the first component of the arterial graft including the guiding means, according to the present invention, in the position illustrated in FIG. 1.
FIG. 5 is similar to FIG. 2, which further shows the guiding means allowing the catheter guidewire to easily enter the connecting opening of the first component of the graft device.
FIG. 6 is a more detailed illustration of the second component being positioned within the connecting opening of the said first component of the device.
FIG. 7 is an schematic illustration of the first component and the coned vertex being undeployed within a catheter sheath, and
FIG. 8 shows the first component of the graft device with the coned vertex once deployed.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
FIG. 1 shows a cross-section view of an abdominal aortic aneurysm being repaired according to a conventional graft device. Aorta 1 shows a mural aneurysm 2, as well as iliac arteries 3 and 4. The graft device 5 comprises a first part or component 6 retained by conventional techniques and an expandable stump device 7 oil the artery wall. In this particular case, body 6 endoluminally covering aorta 1 is inserted by segment 8 within the iliac artery 3. The first component 6 contains a connecting opening 9 aimed at being connected to a second component 10 of the graft device 5 (see FIG. 3) so as to form a bifurcated endoluminal aortic device which covers both the infra-renal aortic level and the two iliac arteries 3 and 4.
As shown in FIGS. 1 to 3, conventional techniques for assembling an aortic device of this type comprise inserting the first component or part 6 and positioning the same as illustrated in FIG. 1. Once the first component 6 of the aortic device is positioned in place, a catheter is introduced by a guidewire 11 intended to locate connecting opening 9 of the first component 5 of the aortic device. Such as illustrated in FIG. 2, the guidewire cannot be easily inserted within wire 9 and end 12 of the wire can possibly perforate the aortic mural thrombus and cause disruption of the latter, as well as embolism of visceral arteries and low extremity arteries.
According to this invention, the second component 10 of the graft device is positioned by a novel process and by a graft device that prevents guidewire 11—and subsequently end 12 thereof—from perforating the aortic wall or damaging any arterial wall. According to this invention, the first component or part 13 of the graft device, as illustrated in FIGS. 4 to 8, comprises a vertex or segment 14 which can be folded together with the first component 13 so as to be introduced within a catheter sheath (see FIG. 7) and be directed therein in a conventional manner. Said segment or vertex 14 is, when deployed, slightly cone- or trumpet-shaped, such as more clearly illustrated in FIG. 8, so that when the first component 13 is mounted within the aortic endoluminal cavity, deployed vertex 14 forms a coned passage which guides the catheter guidewire 11 which, as coming from iliac artery 4, easily enters towards connecting opening 16, equivalent to connecting opening 9 of a conventional graft device. As shown by the different sequences of FIGS. 4, 5 and 6, end 12 of the catheter wire 11 easily enters connecting opening 16 and thus allows the second component 10 to enter along guidewire 11 in order to be connected to connecting opening of the first component 13.
The material used for making vertex 14 can be the same material used for component 13 and second component 10 of the graft device. This material can be a plastic material, a compound material, a metallic material and, in general, it can comprise any expansion mechanism, such as balloon expansion, thermal memory, spring loaded elasticity or auto expansion. In general, the preferred material is nitinol, which forms a dacron covered structure, either inside or outside the device. The material can be covered or coated by polyurethane or polytetrafluorocetylene.
It should be clear from the foregoing description that the steps of the process for inserting an aortic graft device such as that of this invention are safer and simpler than the steps of a conventional process, allow the complete assembly of the device in a prompt manner and further prevent any damage to arterial walls, such as caused by conventional processes.

## Claims

1. An arterial graft device for reinforcing bifurcated arteries having a distal main artery portion and two proximal legs extending from a bifurcation, the arterial graft device comprising a body adapted for at least partial placement in the main artery portion and a separate elongated segment, the body including: (a) an integral elongated segment extending proximally from a bifurcated juncture to a first of the two legs to internally connect the main artery portion with the first leg; and (b) a second segment extending proximally from the bifurcated juncture towards the second leg and comprising:
(i) a first diameter at said bifurcated juncture 
(ii) a connecting portion comprising a second diameter, smaller than said first diameter, proximal said first diameter and adapted to mate with said separate elongated segment, and 
(iii) a guide wire and second segment receiving portion, proximal said connecting portion and of larger diameter than said connecting portion, and a conical transition section between said connecting portion and said larger diameter.

2. The graft device of claim 1 further comprising an expandable retaining device to affix the body to the main artery portion.

3. The graft device of claim 1, wherein the separate elongated segment further comprises an axially extended and entirely circumferentially extended outer connecting surface adapted to bear upon the connecting portion of the body.

4. The graft device of claim 1, wherein the second segment is formed by a foldable structure, which can be compressed and expanded and inserted together with the body within a catheter sheath.

5. The graft device of claim 1, wherein the second segment and the body comprise a unitary structure of the same material.

6. The graft device according to claim 5, wherein the material is selected from the group comprising plastic and metal and the device is expandable by any of the following mechanisms: balloon expansion, thermal memory, elasticity, spring-loaded elasticity, and autoexpansion.

7. The graft device according to claim 5, wherein the material is polyethylene or polytetrafluoroethylene.

8. The graft device according to claim 1, wherein the graft device forms a bifurcated aortic endoluminal graft adapted for being disposed within the infra-renal aorta and the iliac arteries, the integral elongated segment extending into a first iliac artery and the second segment extending in the aorta towards a second iliac artery.

9. An arterial graft device for reinforcing bifurcated arteries having a distal main artery portion and two proximal legs extending from a bifurcation, the arterial graft device comprising a body adapted for at least partial placement in the main artery portion and a separate elongated segment, the body including: (a) an integral elongated segment extending proximally from a bifurcated juncture to a first of the two legs to internally connect the main artery portion with the first leg; and (b) a second segment having a connecting opening and extending towards the second leg and having a connecting surface of distally increasing diameter as the second segment extends from the connecting opening towards the bifurcated juncture and of proximally increasing diameter as the second segment extends from the connecting opening towards the second leg for receiving and guiding a catheter guidewire inserted along the second leg and for guiding the separate elongated segment of the graft device for connection with the second segment.

10. The graft device of claim 9 further comprising an expandable retaining device to affix the body to the main artery portion.

11. The graft device of claim 9, wherein the separate elongated segment further comprises an axially extended and entirely circumferentially extended outer connecting surface adapted to bear upon the connecting surface of the body.

12. The graft device of claim 9, wherein the second segment is formed by a foldable structure, which can be compressed and expanded and inserted together with the body within a catheter sheath.

13. The graft device of claim 9, wherein the second segment and the body comprise a unitary structure of the same material.

14. The graft device according to claim 13, wherein the material is selected from the group comprising plastic and metal and the device is expandable by any of the following mechanisms: balloon expansion, thermal memory, elasticity, spring-loaded elasticity, and autoexpansion.

15. The graft device according to claim 13, wherein the material is polyethylene or polytetrafluoroethylene.

16. The graft device according to claim 9, wherein the graft device forms a bifurcated aortic endoluminal graft adapted for being disposed within the infra-renal aorta and the iliac arteries, the integral elongated segment extending into a first iliac artery and the second segment extending in the aorta towards a second iliac artery.