News Column

Patent Issued for Pre-Loaded Multiport Delivery Device

May 13, 2014



By a News Reporter-Staff News Editor at Journal of Technology -- From Alexandria, Virginia, VerticalNews journalists report that a patent by the inventors Greenberg, Roy K. (Bratenahl, OH); Ivancev, Krasnodar (London, GB); Hartley, David Ernest (Wannanup, AU); Ducke, Werner D. (Eight Mile Plains, AU); Rasmussen, Erik (Slagelse, DK), filed on June 6, 2011, was published online on April 29, 2014.

The patent's assignee for patent number 8709061 is Cook Medical Technologies LLC (Bloomington, IN).

News editors obtained the following quote from the background information supplied by the inventors: "It is known to introduce endovascular stent grafts into the vasculature of a patient to bridge an aneurism or damaged portion of the wall of the vasculature. Problems can occur, however, where the damage to the vasculature includes or is adjacent to a branch vessel from a main artery because occlusion of the branch vessel may cause permanent damage to the patient.

"Examples of such branch vessels are the renal and the mesenteric arteries extending from the aorta.

"Fenestrations in a stent graft have been proposed to allow access to the branch vessel from a main stent graft but it is often necessary to provide a side branch graft to maintain access into the branch vessel. Catheterisation of such a branch vessel from a delivery device through the fenestration enables deployment of a covered stent or uncovered stent into the side vessel. This invention provides an improved apparatus for catheterisation and deployment of side branch grafts.

"Throughout this specification the term distal with respect to a portion of the aorta, a delivery device or a prosthesis means the end of the aorta, delivery 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, delivery 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."

As a supplement to the background information on this patent, VerticalNews correspondents also obtained the inventors' summary information for this patent: "In one form the invention comprises a pre-loaded stent graft delivery device in combination with a stent graft, the stent graft delivery device comprising;

"a guide wire catheter having a guide wire lumen therethrough;

"a handle assembly at a distal end of the guide wire catheter, the handle including a multiport manifold; a nose cone dilator at the proximal end of the guide wire catheter, the nose cone dilator comprising a distal end and a distally facing capsule on the distal end of the nose cone dilator; a pusher catheter extending from the manifold towards the a nose cone dilator, the pusher catheter comprising a longitudinal pusher lumen therethrough and the guide wire catheter extending through the pusher lumen and the guide wire catheter able to move longitudinally and rotationally with respect to the pusher catheter, the pusher catheter comprising a proximal end spaced distally from the nose cone dilator and thereby defining between the proximal end of the pusher catheter and the nose cone dilator a stent graft retention region; the pusher catheter comprising at least one longitudinal auxiliary lumen extending from the manifold to the proximal end of the pusher catheter; a sheath hub on the pusher catheter and a sheath arrangement extending from the sheath hub to the nose cone dilator, the sheath arrangement being coaxial with and surrounding the guide wire catheter; the stent graft comprising a tubular body of a biocompatible graft material, the tubular body comprising a peripheral wall and defining a lumen therethrough, a proximal end, a distal end, at least one fenestration in the peripheral wall and a proximally extending exposed self expanding stent; the stent graft being received on the guide wire catheter in the stent graft retention region and within the sheath, the proximally extending exposed self expanding stent of the stent graft being releasably retained in the distally facing capsule on the distal end of the nose cone dilator; an indwelling access sheath within the or each auxiliary lumen, the indwelling access sheath extending through the manifold from external thereof and having a proximal end terminating distally of the stent graft; an indwelling guide wire within the or each access sheath; the indwelling guide wire extending proximally of the access sheath through the stent graft and exiting the at least one fenestration and extending proximally to the distally facing capsule; whereby upon deployment of the stent graft into the vasculature of a patient the indwelling guide wire can be used to facilitate cathertisation of a side branch or target vessel or be used to stabilise the access sheath during catheterisation, advancement of the access sheath into the target vessel and deployment of a covered or uncovered stent therein through the access sheath.

"Preferably a dilator extends through the or each access sheath and comprises a dilator tip at the proximal end of the or each access sheaths, the dilator being able to be withdrawn through the access sheath.

"Preferably the manifold comprises at least one port and a haemostatic seal assembly in the or each port and the access sheath extending through the haemostatic seal assembly. More preferably the manifold comprises two side ports and a through bore, the two side ports extending distally at an angle from the through bore, the pusher catheter comprising two auxiliary lumens and two side apertures at its distal end and the two side apertures opening respectively into the two auxiliary lumens, the pusher catheter being received into the through bore of the manifold such that the two side apertures open respectively into the two side ports thereby providing a path for the access catheters.

"Preferably pusher catheter comprises two longitudinal auxiliary lumens and the proximal end of the pusher catheter comprises an attachment boss and a scalloped end to provide exit ports for the auxiliary lumens.

"Preferably the handle assembly comprises a proximal handle portion and a distal handle portion, the distal handle portion being movable longitudinally with respect to the proximal handle portion, the guide wire catheter extending through each of the distal handle portion and the proximal handle portion, the guide wire catheter being releasably affixed at a distal end to the distal handle portion, the nose cone dilator and the distal handle portion being movable longitudinally with respect to the proximal handle portion whereby the nose cone dilator can be retracted independently of the manifold and pusher catheter.

"Preferably the pre-loaded stent graft delivery device comprises a distal retrieval taper device in the distally facing capsule, the distal retrieval taper device being mounted onto the guide wire catheter and movable longitudinally with respect to the guide wire catheter, a distal retrieval catheter coaxially on the guide wire catheter and movable longitudinally with respect to the guide wire catheter, the distal retrieval catheter being fixed to the distal retrieval taper device at a proximal end and to the distal handle portion at a distal end, whereby movement of the guide wire catheter in a proximal direction with respect to the distal handle portion moves the distally facing capsule with respect to the distal retrieval taper device such that the distally facing capsule can move over the distal retrieval taper device to allow the distal retrieval taper device to extend from the capsule whereby to provide a smooth transition from the otherwise distal opening of the capsule to enable retraction of the nose cone dilator through a deployed stent graft.

"Preferably the proximal handle portion is releasably fastened to the distal handle portion.

"The stent graft can include diameter reducing ties and the delivery device further includes a release arrangement on the handle assembly for the diameter reducing ties, the release arrangement for the diameter reducing ties comprising a first release grip on the handle and a release wire extending from the first release grip to the diameter reducing ties.

"There can be further included a retention arrangement for the distal end of the stent graft comprising a second release grip on the handle assembly and at least one trigger wire extending from the second release grip through the longitudinal pusher lumen and exiting the pusher lumen at the attachment boss and engaging the distal end of the stent graft.

"The indwelling guide wire extending through the stent graft and exiting the at least one fenestration and extending proximally within the main sheath can comprise a releasable fastening whereby the indwelling guide wire is releasably fastened to the peripheral wall of the stent graft proximally of the fenestration to stabilise the indwelling guide wire during advancement of the dilator and access sheath and catheterisation of the branch vessel. The releasable fastening of the indwelling guide wire can comprise a release wire stitched in to peripheral wall of the stent graft proximally of the fenestration, an engagement protrusion of the indwelling guide wire and a thread engaged around the release wire and the indwelling guide wire distally of the engagement protrusion whereby upon retraction of the release wire the suture is released from engagement with the indwelling guide wire.

"It will be seen that by the various embodiments of the invention there is provided a device where the pusher catheter and the sheaths for each of the side branch catheterisation devices are included within the main sheath of the stent graft with each of the components being able to be manipulated separately. During deployment and before final placement of the covered or uncovered side branch stents the nose cone dilator can be retracted to distal of the fenestrations by movement of the distal handle portion.

"This then generally describes the invention but to assist with understanding reference will now be made the accompanying drawings which show preferred embodiments of the invention."

For additional information on this patent, see: Greenberg, Roy K.; Ivancev, Krasnodar; Hartley, David Ernest; Ducke, Werner D.; Rasmussen, Erik. Pre-Loaded Multiport Delivery Device. U.S. Patent Number 8709061, filed June 6, 2011, and published online on April 29, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=103&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=5150&f=G&l=50&co1=AND&d=PTXT&s1=20140429.PD.&OS=ISD/20140429&RS=ISD/20140429

Keywords for this news article include: Technology.

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Source: Journal of Technology


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