News Column

Patent Issued for Thoracic Deployment Device and Stent Graft

July 8, 2014



By a News Reporter-Staff News Editor at Life Science Weekly -- According to news reporting originating from Alexandria, Virginia, by NewsRx journalists, a patent by the inventors Greenberg, Roy K. (Bratenahl, OH); Hartley, David Ernest (Wannanup, AU); Lawrence-Brown, Michael (City Beach, AU), filed on September 22, 2011, was published online on June 24, 2014 (see also The Cleveland Clinic Foundation).

The assignee for this patent, patent number 8758425, is The Cleveland Clinic Foundation (Cleveland, OH).

Reporters obtained the following quote from the background information supplied by the inventors: "This invention will be generally discussed in relation to deployment of stent grafts into the aorta but it is not so limited and can be applied to other vasculature or other body lumens.

"The introduction of endovascular techniques for the placement of stent grafts into the vascular of human or animal patient has revolutionized the treatment of vascular diseases. As treatment techniques have improved there is a requirement for deployment devices which can provide a physician with more flexibility and control in placement of stent grafts.

"The object of this invention is to provide an introducer for a stent graft which will give a physician more control or at least provide the physician with a useful alternative.

"Throughout this specification the term 'distal' with respect to a portion of the aorta, a deployment device or a prosthesis is the end of the aorta, deployment device or prosthesis further away in the direction of blood flow away from the heart, and the term 'proximal' means the portion of the aorta, deployment device or end of the prosthesis nearer to the heart. When applied to other vessels similar terms such as caudal and cranial should be understood.

"Throughout this discussion the term 'stent graft' is intended to mean a device which has a tubular body of biocompatible graft material and at least one stent fastened to the tubular body to define a lumen through the stent graft. The stent graft may be bifurcated and have fenestrations, side arms or the like. Other arrangements of stent grafts are also within the scope of the invention."

In addition to obtaining background information on this patent, NewsRx editors also obtained the inventors' summary information for this patent: "In one form, the invention is said to reside in a stent graft introducer for intraluminal deployment of a stent graft, the introducer comprising a stent graft retention and release mechanism to allow selective release of each end of the stent graft when carried on the introducer, an indwelling catheter extending from a distal end of the introducer to a proximal end of the introducer and passing through the stent graft when retained on the introducer, whereby control of the stent graft can be maintained while allowing access into the lumen of the stent graft by use of the indwelling catheter.

"Preferably the release mechanism includes a fastening between the stent graft and introducer at both proximal and distal ends of a stent graft retained on the introducer.

"The stent graft introducer may have a sheath surrounding the deployment catheter and preferably the sheath is a highly flexible sheath.

"In a further form the invention is said to reside in a stent graft introducer for intraluminal deployment of a stent graft, an introducer having:

"a guide wire catheter extending from a proximal to a distal end,

"a nose cone dilator on the proximal end of the guide wire catheter, the nose cone dilator having a proximal end and a distal end and a longitudinal groove therein,

"a deployment catheter on the guide wire catheter, the guide wire catheter passing through a lumen in the deployment catheter and the deployment catheter being able to move longitudinally and rotationally with respect to the guide wire catheter,

"a first retention arrangement at the proximal end of the deployment catheter to retain the distal end of a stent graft thereon,

"a second retention arrangement at the distal end of the nose cone dilator to retain the proximal end of a stent graft thereon,

"a release arrangement associated with the handle to separately release the first retention arrangement and the second retention arrangement, and

"an indwelling catheter extending from the handle to the groove in the nose cone dilator.

"Preferably, each release arrangement includes a trigger wire extending from the retention arrangement to a respective trigger wire grip on the handle, and the trigger wire grips are arranged on the handle so that they can only be released in a selected order.

"In a preferred form of the invention the stent graft has a distally extending exposed stent and the first retention arrangement for the distal end of the stent graft includes a capsule covering the exposed stent and acting as the first retention arrangement and a trigger wire associated with the capsule which prevents the exposed stent from being released from the capsule until the trigger wire has been removed as discussed earlier.

"There can be further diameter reducing ties associated with the stent graft when retained on the introducer and the handle including a release arrangement for the diameter reducing ties. The diameter reducing ties comprise loops of suture or other thread material which extend around part of the periphery of the stent graft and are located by a trigger wire and are tightened to reduce the circumference of the stent graft. When released, the stent graft can expand to its full diameter.

"In a preferred form the stent graft has at least one fenestration such that when the stent graft is deployed in the body lumen such as an aorta fluid communication can occur between the lumen of the stent graft and a branch artery of the lumen. For instance in the case of a stent graft deployed in the aorta of a patient then the fenestration may allow access to the renal, mesenteric or coeliac axis arteries. In the case of a stent graft deployed into the descending aorta the fenestration may be at or adjacent the distal end of the stent graft to allow access to a branch artery. The indwelling catheter would allow access from the thoracic arch such as by a brachial or carotid access. Such a fenestration may be in the form of a scallop at the distal end of the stent graft or may be an aperture in the body of the stent graft. The aperture may be reinforced with a resilient wire ring around its periphery. When the stent graft has been at least partially released the resilient wire ring will cause the fenestration to open to assist with access through the fenestration.

"Preferably the introducer further comprises an indwelling catheter extending from a distal end of the introducer to a proximal end of the introducer and passing through the stent graft when retained on the introducer. Preferably the indwelling catheter extends through the deployment catheter to the nose cone dilator to be received in the groove therein. Preferably the indwelling catheter extends through the fenestration.

"In a further form the invention is said to reside in a stent graft introducer for intraluminal deployment of a stent graft, an introducer having:

"a guide wire catheter extending from a proximal to a distal end,

"a nose cone dilator on the proximal end of the guide wire catheter, the nose cone dilator having a proximal end and a distal end,

"a deployment catheter on the guide wire catheter, the guide wire catheter passing through a lumen in the deployment catheter and the deployment catheter being able to move longitudinally and rotationally with respect to the guide wire catheter,

"a distal retention arrangement a the proximal end of the deployment catheter to retain the distal end of a stent graft thereon and an associated distal release arrangement,

"a proximal retention arrangement at the distal end of the nose cone dilator to retain the proximal end of a stent graft thereon and an associated proximal release arrangement, the proximal retention arrangement including multiple fastenings between the stent graft and the release mechanism,

"a first release arrangement associated with the handle to release the distal retention arrangements,

"a second release arrangement associated with the handle to release the proximal fastenings,

"each release arrangement including a trigger wire extending from the respective retention arrangement to a trigger wire grip on the handle,

"the trigger wire grips being arranged on the handle so that they can only be released in a selected order.

"There can be further diameter reducing ties associated with the stent graft when retained on the introducer and the handle including a release arrangement for diameter reducing ties on the stent graft.

"In a preferred form of the invention the stent graft has a distally extending exposed stent and the distal retention arrangement includes a capsule to cover the exposed stent and the distal release arrangement includes means to withdraw the capsule from the exposed stent. There can be further included a capsule trigger wire associated with the capsule which engages with the exposed stent within the capsule and prevents the capsule from being removed from the exposed stent until the capsule trigger wire has been removed and there is a respective trigger wire grip on the handle.

"In a preferred form the stent graft has at least one fenestration at a distal end thereof such that when the stent graft is deployed in the body lumen, such as an aorta, fluid communication can occur between the lumen of the stent graft and a branch artery of the lumen. For instance, in the case of a stent graft deployed in the aorta of a patient then the fenestration may allow access to the renal, mesenteric or coeliac axis arteries.

"The fenestration may be an aperture through the wall of the stent graft or may be a cut out in an end of the stent graft.

"The stent graft may comprise a tubular body of a biocompatible graft material and a plurality of stents to define in use a lumen through the stent graft.

"In an alternative form the invention is said to reside in a stent graft introducer for intraluminal deployment of a stent graft, the introducer comprising a stent graft release mechanism to allow partial release of at least one end of the stent graft when carried on the introducer, whereby control of the stent graft can be maintained while allowing access into the lumen of the stent graft through the partially released at least one end of the stent graft.

"Preferably the release mechanism includes a fastening between the stent graft and introducer at both proximal and distal ends of a stent graft retained on the introducer and the partial release releases at least part of the fastening at either the proximal or distal end.

"Preferably the partial release is only a part of the total fastening at either the proximal or distal end and hence because there is still some retention at both the proximal and distal ends of the stent graft, control of the positioning of the stent graft within a body lumen is still possible.

"In a preferred embodiment retention of either the proximal or distal ends of the stent graft includes at least three fastenings between the stent graft and a release mechanism with the fastening spaced around the periphery of the stent graft and the partial release releases at one of these at least three fastenings thereby releasing part of the end of the stent graft to allow the access as discussed above.

"In a further form the invention is said to reside in a stent graft introducer for intraluminal deployment of a stent graft, the introducer having proximal and distal stent graft release mechanisms, the proximal release mechanism having at least two fastenings between the stent graft and at least two release mechanisms for the fastenings at the proximal end to allow partial release of part of the proximal end of the stent graft when carried on the introducer, whereby control of the stent graft can be maintained while allowing access into the lumen of the stent graft from the partially released proximal end of the stent graft.

"In a further form the invention is said to reside in a stent graft introducer for intraluminal deployment of a stent graft, an introducer comprising:

"a guide wire catheter extending from a proximal to a distal end,

"a nose cone dilator on the proximal end of the guide wire catheter, the nose cone dilator having a proximal end and a distal end,

"a deployment catheter on the guide wire catheter, the guide wire catheter passing through a lumen in the deployment catheter and the deployment catheter being able to move longitudinally and rotationally with respect to the guide wire catheter,

"a first retention arrangement at the proximal end of the deployment catheter to retain the distal end of a stent graft thereon,

"a second retention arrangement at the distal end of the nose cone dilator to retain the proximal end of a stent graft thereon,

"a release arrangement associated with the handle to separately release the first retention arrangement and the second retention arrangement,

"either the first or the second retention arrangement including multiple fastenings between the stent graft and the release mechanism and wherein one of the multiple fastenings can be released independently of the others of the multiple fastenings,

"a stent graft retained on the introducer, the stent graft comprising at least one fenestration whereby when the stent graft is deployed in a body lumen fluid communication can occur between the lumen of the stent graft and a branch artery of the lumen through the fenestration,

"an indwelling catheter extending from a distal end of the introducer through the deployment catheter to a proximal end of the stent graft when retained on the introducer,

"and the indwelling catheter extending through the fenestration.

"In one embodiment the fenestration comprises a scallop at the distal end of the stent graft. Alternatively the fenestration is an aperture in the body of the stent graft and being reinforced with a resilient wire ring around its periphery.

"The graft material may be a woven or non-woven fabric such as Dacron or may be a polymeric material such as expandable PTFE. The graft material may alternatively be a naturally occurring biomaterial, such as collagen, particularly a specially derived collagen material known as an extracellular collagen matrix (ECM), such as small intestinal submucosa (SIS) that causes remodelling of host tissue coming into contact therewith. Besides SIS, examples of ECM=s include pericardium, stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa, and dura mater.

"The plurality of stents may be self-expanding zig zag stents or may be balloon expandable stents or other forms of stent.

"U.S. Pat. No. 5,387,235 entitled 'Expandable Transluminal Graft Prosthesis For Repair Of Aneurysm' discloses apparatus and methods of retaining grafts onto deployment devices. These features and other features disclosed in U.S. Pat. No. 5,387,235 could be used with the present invention and the disclosure of U.S. Pat. No. 5,387,235 is herewith incorporated in its entirety into this specification.

"U.S. Pat. No. 5,720,776 entitled 'Barb and Expandable Transluminal Graft Prosthesis For Repair of Aneurysm' discloses improved barbs with various forms of mechanical attachment to a stent. These features and other features disclosed in U.S. Pat. No. 5,720,776 could be used with the present invention and the disclosure of U.S. Pat. No. 5,720,776 is herewith incorporated in its entirety into this specification.

"PCT Patent Publication No. WO 98/53761 entitled 'A Prosthesis And A Method And Means Of Deploying A Prosthesis' discloses an introducer for a prosthesis which retains the prosthesis so that each end can be moved independently. These features and other features disclosed in PCT Patent Publication No. WO 98/53761 could be used with the present invention and the disclosure of PCT Patent Publication No. WO 98/53761 is herewith incorporated in its entirety into this specification.

"U.S. Pat. No. 6,524,335 and PCT Patent Publication No. WO 99/29262 entitled 'Endoluminal Aortic Stents' disclose a fenestrated prosthesis for placement where there are intersecting arteries. This feature and other features disclosed in U.S. Pat. No. 6,524,335 and PCT Patent Publication No. WO 99/29262 could be used with the present invention and the disclosure of U.S. Pat. No. 6,524,335 and PCT Patent Publication No. WO 99/29262 is herewith incorporated in its entirety into this specification.

"U.S. patent application Ser. No. 10/280,486, filed Oct. 25, 2002 and published on May 8, 2003 as U.S. Patent Application Publication No. US-2003-0088305-A1 and PCT Patent Publication No. WO 03/034948 entitled 'Prostheses For Curved Lumens' discloses prostheses with arrangements for bending the prosthesis for placement into curved lumens. This feature and other features disclosed in U.S. patent application Ser. No. 10/280,486, and U.S. Patent Application Publication No. US-2003-0088305-A1 and PCT Patent Publication No. WO 03/034948 could be used with the present invention and the disclosure of U.S. patent application Ser. No. 10/280,486, and U.S. Patent Application Publication No. US-2003-0088305-A1 and PCT Patent Publication No. WO 03/034948 is herewith incorporated in its entirety into this specification.

"U.S. Pat. No. 6,206,931 entitled 'Graft Prosthesis Materials' discloses graft prosthesis materials and a method for implanting, transplanting replacing and repairing a part of a patient and particularly the manufacture and use of a purified, collagen based matrix structure removed from a submucosa tissue source. These features and other features disclosed in U.S. Pat. No. 6,206,931 could be used with the present invention and the disclosure of U.S. Pat. No. 6,206,931 is herewith incorporated in its entirety into this specification.

"U.S. Provisional Patent Application Ser. No. 60/392,682, filed Jun. 28, 2002, U.S. patent application Ser. No. 10/447,406, filed May 29, 2003, and Published on Dec. 18, 2003, as U.S. Patent Application Publication No. US-2003-0233140-A1, and PCT Patent Publication No. WO 03/101518 entitled 'Trigger Wires' disclose release wire systems for the release of stent grafts retained on introducer devices. This feature and other features disclosed in U.S. Provisional Patent Application Ser. No. 60/392,682, U.S. patent application Ser. No. 10/447,406, and U.S. Patent Application Publication No. US-2003-0233140-A1, and PCT Patent Publication No. WO 03/101518 could be used with the present invention and the disclosure of U.S. Provisional Patent Application Ser. No. 60/392,682, U.S. patent application Ser. No. 10/447,406, and U.S. Patent Application Publication No. US-2003-0233140-A1, and PCT Patent Publication No. WO 03/101518 is herewith incorporated in its entirety into this specification.

"U.S. Provisional Patent Application Ser. No. 60/392,667, filed Jun. 28, 2002, and U.S. patent application Ser. No. 10/609,846, filed Jun. 30, 2003, and Published on May 20, 2004, as US Patent Application Publication No. US-2004-0098079-A1, and PCT Patent Publication No. WO 2004/028399 entitled 'Thoracic Deployment Device' disclose 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 Ser. No. 60/392,667, U.S. patent application Ser. No. 10/609,846, and US Patent Application Publication No. US-2004-0098079-A1, and PCT Patent Publication No. WO 2004/028399 could be used with the present invention and the disclosure of U.S. Provisional Patent Application Ser. No. 60/392,667, U.S. patent application Ser. No. 10/609,846, and US Patent Application Publication No. US-2004-0098079-A1, and PCT Patent Publication No. WO 2004/028399 is herewith incorporated in its entirety into this specification.

"U.S. Provisional Patent Application Ser. No. 60/392,599, filed Jun. 28, 2002, and U.S. patent application Ser. No. 10/609,835, filed Jun. 30, 2003, entitled 'Thoracic Aortic Aneurysm Stent Graft' disclose stent grafts that are useful in treating aortic aneurysms particularly in the thoracic arch. This feature and other features disclosed in U.S. Provisional Patent Application Ser. No. 60/392,599 and U.S. patent application Ser. No. 10/609,835, filed Jun. 30, 2003 could be used with the present invention, and the disclosure are herewith incorporated in their entirety into this specification.

"U.S. Provisional Patent Application Ser. No. 60/392,599, filed Jun. 28, 2002, and U.S. patent application Ser. No. 10/609,835, filed Jun. 30, 2003, and published on Jun. 3, 2004, as U.S. Patent Application Publication No. US-2004-0106978-A1, and PCT Patent Publication No. WO 2004/002370 entitled 'Thoracic Aortic Aneurysm Stent Graft' disclose stent grafts that are useful in treating aortic aneurysms particularly in the thoracic arch. This feature and other features disclosed in U.S. Provisional Patent Application Ser. No. 60/392,599, U.S. patent application Ser. No. 10/609,835, and U.S. Patent Application Publication No. US-2004-0106978-A1, and PCT Patent Publication No. WO 2004/002370 could be used with the present invention, and the disclosure of U.S. Provisional Patent Application Ser. No. 60/392,599, U.S. patent application Ser. No. 10/609,835, and U.S. Patent Application Publication No. US-2004-0106978-A1, and PCT Patent Publication No. WO 2004/002370 is herewith incorporated in its entirety into this specification.

"U.S. Provisional Patent Application Ser. No. 60/405,367, filed Aug. 23, 2002, U.S. patent application Ser. No. 10/647,642, filed Aug. 25, 2003, and published on Apr. 15, 2004, as U.S. Patent Application Publication No. US-2004-0073289-A1, and PCT Patent Publication No. WO 2004/017868 entitled 'Asymmetric Stent Graft Attachment' disclose retention arrangements for retaining onto and releasing prostheses from introducer devices. This feature and other features disclosed in U.S. Provisional Patent Application Ser. No. 60/405,367, filed Aug. 23, 2002, U.S. patent application Ser. No. 10/647,642, filed Aug. 25, 2003, and U.S. Patent Application Publication No. US-2004-0073289-A1, and PCT Patent Publication No. WO 2004/017868 could be used with the present invention and the disclosure of U.S. Provisional Patent Application Ser. No. 60/405,367, filed Aug. 23, 2002, U.S. patent application Ser. No. 10/647,642, filed Aug. 25, 2003, and U.S. Patent Application Publication No. US-2004-0073289-A1, and PCT Patent Publication No. WO 2004/017868 is herewith incorporated in its entirety into this specification.

"U.S. patent application Ser. No. 10/322,862, filed Dec. 18, 2002 and published as U.S. Patent Application Publication No. US2003-0120332, and PCT Patent Publication No. WO 03/053287 entitled 'Stent Graft With Improved Adhesion' disclose arrangements on stent grafts for enhancing the adhesion of such stent grafts into walls of vessels in which they are deployed. This feature and other features disclosed in U.S. patent application Ser. No. 10/322,862, filed Dec. 18, 2002 and published as U.S. Patent Application Publication No. US2003-0120332, and PCT Patent Publication No. WO 03/053287 could be used with the present invention and the disclosure of U.S. patent application Ser. No. 10/322,862, filed Dec. 18, 2002 and published as U.S. Patent Application Publication No. US2003-0120332, and PCT Patent Publication No. WO 03/053287 is herewith incorporated in its entirety into this specification.

"U.S. Provisional Patent Application Ser. No. 60/405,769, filed Aug. 23, 2002, U.S. patent application Ser. No. 10/645,095, filed Aug. 23, 2003, and published on Apr. 29, 2004, as U.S. Patent Application Publication No. US-2004-0082990-A1, and PCT Patent Publication No. WO 2004/017867 entitled 'Composite Prostheses' discloses prostheses or stent grafts suitable for endoluminal deployment. These prostheses and other features disclosed in U.S. Provisional Patent Application Ser. No. 60/405,769, U.S. Patent Application Ser. No. 10/645,095, and U.S. Patent Application Publication No. US-2004-0082990-A1, and PCT Patent Publication No. WO 2004/017867 could be used with the present invention and the disclosure of U.S. Provisional Patent Application Ser. No. 60/405,769, U.S. patent application Ser. No. 10/645,095, and U.S. Patent Application Publication No. US-2004-0082990-A1, and PCT Patent Publication No. WO 2004/017867 is herewith incorporated in its entirety into this specification."

For more information, see this patent: Greenberg, Roy K.; Hartley, David Ernest; Lawrence-Brown, Michael. Thoracic Deployment Device and Stent Graft. U.S. Patent Number 8758425, filed September 22, 2011, and published online on June 24, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8758425.PN.&OS=PN/8758425RS=PN/8758425

Keywords for this news article include: Patents, Extracellular Matrix Proteins, The Cleveland Clinic Foundation.

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