Source: https://patents.google.com/patent/US20040176832
Timestamp: 2018-04-21 02:21:37
Document Index: 355366894

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60']

US20040176832A1 - Method and device for treating aortic dissection - Google Patents
US20040176832A1
US20040176832A1 US10726963 US72696303A US2004176832A1 US 20040176832 A1 US20040176832 A1 US 20040176832A1 US 10726963 US10726963 US 10726963 US 72696303 A US72696303 A US 72696303A US 2004176832 A1 US2004176832 A1 US 2004176832A1
US10726963
US9408731B2 (en )
A prosthesis adapted for inter-luminal placement by endovascular deployment for the treatment of vascular dissection, the prosthesis has a self expanding stents (38) connected together to define an elongate lumen wall engaging surface. At least one of the stents has a biocompatible graft material cover (36) to define a covered portion (25). The cover is adapted to close off a rupture (7) in the wall of the lumen (6) and the stents are adapted to provided pressure on the wall of the lumen adjacent to and extending away from the rupture.
This application claims priority of provisional application Serial No. 60/430,825, filed Dec. 4, 2002.
This invention relates to a method and a device for the treatment of aortic arch disease and more particularly to the treatment of a form of aortic aneurysm known as an aortic dissection.
Preferably the cover portion encompasses two or three stents and the cover is stitched or otherwise fastened to the stents in the covered portion.
Preferably the covered portion of the prosthesis is at the proximal end of the plurality of stents.
In one preferred embodiment of the invention there may be three covered stents each of the zig-zag type and constructed from stainless steel or nitinol and up to eight or ten uncovered stents formed from stainless steel or nitinol.
The uncovered stents may be of the Gianturco type zigzag stent and constructed so that in their expanded state they provide a low but useful radial force on the aorta wall.
Alternatively the uncovered portion may be in the form of a self expanding spiral of zig-zag configuration.
In a further form the invention may be said to reside in a prosthesis for treatment of an aortic dissection comprising a substantially cylindrical body in the expanded state having at least one self expanding stent covered by a bio-compatible graft material and a self expanding stent assembly extending from a distal end thereof.
There may be included barbs extending from the proximal end of the graft.
In one embodiment the self expanding stent assembly extending from a distal end of the biocompatible graft material may be formed from a biocompatible and biodegradable mesh material so that after it has performed its work of providing a radial pressure onto the wall of the aorta it can biodegrade in the bloodstream.
In a further form the invention may be said to reside in a deployment device and prosthesis for treatment of an aortic dissection, the prosthesis comprising a substantially cylindrical body in the expanded state having at least one self expanding stent covered by a bio-compatible graft material and a self expanding stent assembly extending from a distal end thereof, and the deployment device comprising an elongate catheter adapted to be deployed over a guide wire, a nose cone at the proximal end of the elongate catheter, a trigger wire arrangement adapted to retain a proximal end of the prosthesis in a retracted state, a sheath arrangement over the elongate catheter adapted to retain the prosthesis in a contracted state around the elongate catheter, means at the distal end of the elongate catheter to release the trigger wire arrangement and means to withdraw the sheath arrangement.
Preferably the elongate catheter includes means to supply an angiographic contrast medium at a distal end thereof through the catheter and the nose cone includes discharge ports for the angiographic contrast medium.
In an alternative form the invention is said to reside in a method of treatment of aortic dissection disease comprising the steps of loading a prosthesis onto a deployment device, the prosthesis comprising a plurality of self expanding stents together defining an elongate substantially cylindrical lumen wall engaging surface and at least one of the stents having a bio-compatible graft material cover whereby the cover is adapted to close off a rupture in the wall of the lumen, the deployment device including means to retain the proximal end of the prosthesis in a retracted state and a trigger wire arrangement to release the proximal end of the prosthesis, a sheath to retain the entire prosthesis in a retracted state and means to withdraw the sheath, endovascularly deploying the deployment device with the prosthesis loaded thereon to the site of the aortic dissection, checking by radiographic techniques that the covered stent or stents are at the site of the aortic dissection, withdrawing the sheath to expose the covered stent or stents of the prosthesis, releasing the proximal end of the prosthesis by means of releasing the trigger wire arrangement, withdrawing the sheath to deploy the other stents of the prosthesis along the wall of the lumen such that they provide pressure against the wall of the lumen, and withdrawing the deployment device.
Preferably the covered stent or stents are at the proximal end of the prosthesis.
SIS is particularly useful, and can be made in the fashion described in Badylak et al., U.S. Pat. No. 4,902,508; Intestinal Collagen Layer described in U.S. Pat. No. 5,733,337 to Carr and in 17 Nature Biotechnology 1083 (Nov. 1999); Cooket al., WIPO Publication WO 98/22158, dated 28 May 1998, which is the published application of PCT/US97/14855. Irrespective of the origin of the material (synthetic versus naturally occurring), the material can be made thicker by making multilaminate constructs, for example SIS constructs as described in U.S. Pat. Nos. 5,968,096; 5,955,110; 5,885,619; and 5,711,969. Animal data show that the SIS used in grafts can be replaced by native tissue in as little as a month's time. In addition to xenogenic biomaterials, such as SIS, autologous tissue can be harvested as well. Additionally Elastin or Elastin-Like Polypetides (ELPs) and the like offer potential as a material to fabricate the graft to form a device with exceptional biocompatibility. Another alternative would be to use allographs such as harvested native tissue. Such tissue is commercially available in a cryopreserved state.
U.S. Provisional Patent Application No. 60/392,667, now Ser. Nos. 10/609,846 filed Jun. 30, 2003, and PCT Patent Application No. PCT/US03/204963 filed Jun. 30, 2003, entitled “Thoracic Deployment Device” discloses introducer devices adapted for deployment of stent grafts particularly in the thoracic arch. This feature and other features disclosed in U.S. Provisional Patent Application No. 60/392,667 could be used with the present invention and the disclosure of U.S. Provisional Patent Application No. 60/392,667 is herewith incorporated in its entirety into this specification.
U.S. Provisional Patent Application No. 60/391,737, now Ser. Nos. 10/602,930, filed Jun. 24, 2003, and PCT Patent Application No. PCT/US03/19997, filed Jun. 24, 2003, entitled “Stent-Graft Fastening Arrangement” discloses arrangements for fastening stents onto grafts particularly for exposed stents. This feature and other features disclosed in U.S. Provisional Patent Application No. 60/391,737 could be used with the present invention and the disclosure of U.S. Provisional Patent Application No. 60/391,737 is herewith incorporated in its entirety into this specification.
U.S. Utility patent application Ser. No. 10/647,642 entitled “Asymmetric Stent Graft Attachment” discloses retention arrangements for retaining onto and releasing prostheses from introducer devices. This feature and other features disclosed in U.S. Utility patent application Ser. No. 10/647,642 could be used with the present invention and the disclosure of U.S. Utility patent application Ser. No. 10/647,642 is herewith incorporated in its entirety into this specification.
This then generally describes the invention but to assist with understanding reference will now be made to the drawings which show a preferred embodiment of the invention.
[0036]FIG. 1 shows a schematic view of an aorta with an aortic dissection;
[0037]FIG. 2 shows the aorta shown in FIG. 1 with a deployment device inserted therein;
[0038]FIG. 3 shows the first stage of deployment of the prosthesis;
[0039]FIG. 4 shows the fully deployed prosthesis;
[0040]FIG. 5 shows a prosthesis according to one embodiment of this invention;
[0041]FIG. 6 shows an alternative embodiment of the prosthesis according to the invention; and
[0042]FIG. 7 shows a still further embodiment of the prosthesis according to the invention.
As can be seen in FIG. 2 a deployment device 15 with a nose cone 16 has been advanced over a guide wire 17 through the true lumen 18 of the descending aorta 6. Preferably the deployment device is inserted through a femoral artery and up through the iliac arteries into the aorta.
Once the deployment device is in substantially the correct place angiographic fluids may be supplied through a hollow elongate catheter 20 in the deployment device to exit through apertures 22 in the nose cone so that with the angiographic contrast medium the region can be visualised by radiographic techniques.
When the deployment device is found to be in the correct position the sheath 24 of the deployment device is withdrawn to the position as shown in FIG. 3 at which stage the covered portion 25 of the prosthesis is exposed except that the proximal end 27 is retained by a trigger wire mechanism to the central catheter 20. The sheath is withdrawn until the first of the uncovered stents 29 of the prosthesis are exposed. At this stage the pressure of blood flow from the heart will still tend to cause blood flow around the prosthesis.
Next the trigger wire mechanism is released so that the proximal end 27 of the prosthesis 25 is allowed to open as shown in FIG. 4 and the barbs 30 on the proximal end of 27 of the prosthesis engage against the wall of the aorta to securely fix the covered portion 25 of the prosthesis in the upper end of the descending aorta with the covered portion 25 of the prosthesis covering the rupture 7 and essentially closing it off so that blood can no longer flow into the false lumen 10. Blood can then flow through the covered portion of the prosthesis and exit out the end of the covered portion at the first stent 29 and then as the sheath 23 is continued to be withdrawn the remaining self expanding stents are allowed to engage against the wall of the true lumen 18 and provide pressure onto the wall particularly where the false lumen occurs to gradually deflate and close off the false lumen as finally shown in FIG. 4. At this stage the sheath 23 is advanced to the nose cone 16 and the deployment device is withdrawn.
[0049]FIG. 5 shows a prosthesis for use with the method of the present invention. The prosthesis has three stents 35 under a biocompatible graft material cover 36 which provides the covered portion 25 of the prosthesis and a number of uncovered stents 38 each of which are linked to the next stent up or down by flexible links 37. The covered portion is joined to the uncovered portion by links. The flexible links enable each stent to expand separately as the false lumen is deflated which may occur over a period of several days or weeks. The stents provide gradual pressure on the wall of the lumen to close the false lumen and open up the true lumen.
It will be realised that different numbers of covered stents and uncovered stents may be used depending upon the nature of the aortic dissection and the length of aorta to be opened and the dimensions of the rupture in the wall of the aorta.
[0055]FIG. 6 shows a further embodiment of a prosthesis according to the present invention.
In this embodiment the covered portion is the same as in the previous embodiment shown in FIG. 5 but the uncovered self expanding stents 40 are linked by means of a fibre or thread 42 such as a suture so that each self expanding stent can act independently of its neighbours. Where each fibre or suture 42 passes a bend 41 of a stent there may be a knot 43 such as a clove hitch to assist with the controlled linking of adjacent stents. Threads or sutures 44 join the proximal uncovered stents 40 to the covered portion 25 of the prosthesis.
[0057]FIG. 7 shows a still further embodiment of the prosthesis of the invention.
In this embodiment the covered portion is the same as in the previous embodiment shown in FIG. 5 but the uncovered portion is formed from a continuous spiral of zig-zag stent 45 with again loops in adjacent spirals joined by a thread 47 such as a suture. Again suitable knots may be used to assist with the controlled linking of adjacent portions of the spiral stent. Threads or sutures 49 join the uncovered spiral stent 45 with the covered portion 25 of the prosthesis.
1. A prosthesis adapted for inter-luminal placement by endovascular deployment, the prosthesis comprising a plurality of self expanding stents together defining an elongate substantially cylindrical lumen wall engaging surface and at least one of the stents having a biocompatible graft material cover defining a covered portion, whereby the cover is adapted to close off a rupture in the wall of the lumen and the stents are adapted to provided pressure on the wall of the lumen adjacent to and extending away from the rupture.
15. A method of treatment of aortic dissection disease comprising the steps of
a) loading a prosthesis onto a deployment device, the prosthesis comprising a plurality of self expanding stents together defining an elongate substantially cylindrical lumen wall engaging surface and at least one of the stents having a bio-compatible graft material cover, whereby the cover is adapted to close off a rupture in the wall of the lumen, the deployment device including means to retain a proximal end of the prosthesis in a retracted state and a trigger wire arrangement to release the proximal end of the prosthesis, a sheath to retain the entire the prosthesis in a retracted state and means to withdraw the sheath,
b) endovascularly deploying the deployment device with the prosthesis loaded thereon to the site of the aortic dissection,
c) checking by radiographic techniques that the covered stent or stents are at the site of the aortic dissection,
d) withdrawing the sheath to expose the covered stent or stents of the prosthesis,
e) releasing the proximal end of the prosthesis by means of releasing the trigger wire arrangement,
f) withdrawing the sheath to deploy the other stents of the prosthesis along the wall of the lumen such that they provide pressure against the wall of the lumen, and
g) withdrawing the deployment device.
US10726963 2002-12-04 2003-12-03 Method and device for treating aortic dissection Active 2030-09-20 US9408731B2 (en)
US43082502 true 2002-12-04 2002-12-04
US10726963 US9408731B2 (en) 2002-12-04 2003-12-03 Method and device for treating aortic dissection
US20040176832A1 true true US20040176832A1 (en) 2004-09-09
US9408731B2 US9408731B2 (en) 2016-08-09
US10726963 Active 2030-09-20 US9408731B2 (en) 2002-12-04 2003-12-03 Method and device for treating aortic dissection
JP2007135627A (en) * 2005-11-14 2007-06-07 Jms Co Ltd Treatment instrument for aortic dissection
EP1567093A1 (en) 2005-08-31 application
DK1567093T3 (en) 2009-04-06 grant
DE60326000D1 (en) 2009-03-12 grant
WO2004049978A1 (en) 2004-06-17 application
EP1567093B1 (en) 2009-01-21 grant
US9408731B2 (en) 2016-08-09 grant
CA2506423C (en) 2011-04-19 grant
CA2506423A1 (en) 2004-06-17 application
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HARTLEY, DAVID ERNEST;NIXON, IAN;MOSSOP, PETER JOHN;SIGNING DATES FROM 20020920 TO 20020923;REEL/FRAME:026074/0712
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:COOK INCORPORATED;REEL/FRAME:026231/0065
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:WILLIAM A. COOK AUSTRALIA PTY. LTD.;REEL/FRAME:038758/0904