News Column

Researchers Submit Patent Application, "Embolic Implant and Method of Use", for Approval

June 19, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- From Washington, D.C., VerticalNews journalists report that a patent application by the inventors Strauss, Brian M. (Irvine, CA); Valko, Jeffrey J. (Irvine, CA); Lenker, Jay A. (Laguna Beach, CA); Pecor, Robert A. (Irvine, CA); Barker, Peter (Irvine, CA); Castaneda, Maricruz (Irvine, CA), filed on February 3, 2014, was made available online on June 5, 2014.

The patent's assignee is Reverse Medical Corporation.

News editors obtained the following quote from the background information supplied by the inventors: "The devices described below are intended for treatment of defects in the cerebral arteries and veins. Defects of the cerebral arteries include aneurysms, fusiform aneurysms, arteriovenous malformations, arteriovenous fistulas, cavernous fistulas and dissections and other hyper-vascular lesions (head and neck tumors, etc.). These defects cause of variety of symptoms, ranging from headache and vision loss to stroke and death. Preferably, these defects would be treated with devices and techniques that leave the associated parent artery or vein intact and patent so that it may continue to supply blood to regions of the brain which it naturally supplies. Such techniques include filling an aneurysm with occlusive polymers or occlusive coils, or inserting stents or covered stents, where feasible. In many cases, however, this is not advisable or possible because the artery vein segment in which the defect, or the defect itself, will not accommodate the devices, or because the patient's condition indicates that immediate cessation of blood flow is required.

"The alternate, when parent artery preservation is not advisable, is parent artery occlusion, or PAO. Parent artery occlusion is accomplished by quickly and securely closing off a length of a blood vessel near the defect, and preferably results in immediate and complete blockage of blood flow to the defect, and permanent isolation of the blood vessel segment near the defect. Parent artery occlusion is sometimes referred to more broadly as parent vessel occlusion, to encompass occlusion of both arteries and veins. Several endovascular devices and techniques have been developed to accomplish parent artery occlusion. Detachable balloons have previously been proposed and used for parent artery occlusion, but were not successful because the balloons to often leaked and deflated, leading to major embolic complications. (Giant Intracranial Aneurysms at 257 (Awad, Issam and Barrow, Daniel, eds., Thieme/AANS 1st ed., 1995)). Occlusive coils have been used to pack fusiform aneurysms and cavernous fistulas, but this is extremely expensive (it may require dozens of coils) and does not result in immediate occlusion. Thus, trickling blood flow, which occurs for several minutes while the patient's blood is coagulating around the mass of coils, may lead to creation and migration of thrombus from the mass of coils. Vascular plugs have been used to accomplish parent artery occlusion. Currently available plugs, such as the Amplatzer vascular plug, are used off-label in the neuro-vasculature, and are difficult to deploy. Ross, et al., The Vascular Plug: A New Device for Parent Artery Occlusion, 28 AJNR Am J Neuroradiology 385 (February 2007). Also, the open-mesh construction of these vascular plugs may result in dislodgement of thrombus as it is forming on the plug, leading to embolization downstream of the occluded artery."

As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventors' summary information for this patent application: "The devices and methods described below provide for expeditious embolization of arteries of the neuro-vasculature with an embolic implant, and suitable for use as a parent artery occlusion device within a cerebral artery (or within a cerebral vein). The devices may also be deposited in aneurysms. The embolic implant includes a self-expanding cage-like wire-frame structure, which may be elongate or spherical, or oblate or prolate spheroid, which is covered with a polymer membrane. The embolic device is releasably attached to the delivery catheter with mechanical attachment means such as detents, electrolytic detachment or other suitable detachment means. Upon release from the delivery catheter, the embolic device expands toward its unrestrained shape, to the extent allowed by the surrounding cerebral artery. Expansion of the cage like structure, and concurrent expansion of the membrane, results in immediate occlusion of the cerebral artery. In recent comparative studies, the embolic implant stopped blood flow in an artery in about 15 seconds, as compared to the Amplatzer.TM. vascular plug, which took 3 minutes to stop blood flow.

"Additionally these devices are used to perform pre-operative de-vascularization and test occlusions. Additional embolic implants are also disclosed, which include a cage-like bodies formed with struts and restraining bands. Though proposes for use within the cerebral vasculature, the devices may also be used to treat defects blood vessels throughout the body.

BRIEF DESCRIPTION OF THE DRAWINGS

"FIG. 1 is a schematic diagram of the vasculature of the brain showing a typical placement of an intra-cranial embolic device.

"FIG. 2 is schematic diagram of the vascular of the brain illustrating the circle of Willis and arteries supplying the circle of Willis.

"FIG. 3 illustrates an embolic implant with a oblong prolate wire-frame structure which is partially covered with a membrane.

"FIG. 4 illustrates the several segments of the parent artery occlusion device.

"FIG. 5 illustrates a side view of an embolic implant, comprising a plurality of longitudinal struts, in its unexpanded state.

"FIG. 6 illustrates a side view of an embolic implant of FIG. 5, which has been radially expanded by foreshortening the distance between its two ends.

"FIG. 7 illustrates a side view of the unexpanded embolic implant of FIG. 6 releasably affixed to the distal end of a delivery catheter and further inserted through the lumen of a guide catheter along with a guidewire.

"FIG. 8 illustrates a side view of the embolic implant of FIG. 6 releasably affixed to the distal end of the delivery catheter and advanced out the distal end of the guide catheter along with the guidewire, allowing the implant to expand radially.

"FIG. 9 illustrates the expanded embolic implant of FIG. 2B wherein the guidewire has been withdrawn so that the distal end of the guidewire is proximal to the proximal end of the implant such that the implant is released from the delivery catheter.

"FIG. 10 illustrates the embolic implant of FIG. 9 wherein the delivery catheter has been withdrawn proximally away from the released embolic implant.

"FIG. 11 illustrates the embolic implant of FIG. 7, rotated 90 degrees, in a side partial breakaway view such that the releasable locking mechanism is illustrated.

"FIG. 12 illustrates the embolic implant of FIG. 11 in partial breakaway view with the guidewire having been withdrawn and the locking mechanism released from the embolic implant.

"FIG. 13 illustrates a side view of an embolic implant comprising a plurality of radially expandable struts over which a membrane has been affixed.

"FIG. 14 illustrates a side view of an embolic implant comprising a porous mesh disposed over, and affixed to, the expandable struts.

"FIG. 15 illustrates a side view of an embolic implant comprising a plurality of struts affixed to a cylindrical proximal end and coming together at the distal end such that substantially nothing projects distally of the struts.

"FIG. 16 illustrates an end view of the embolic implant of FIG. 8A showing how the struts come together at the distal end.

"FIG. 17 illustrates a side view of an expanded embolic implant still connected to its delivery catheter, with its delivery sheath partially retracted and shown in cross-section, wherein the implant comprises a plurality of longitudinally disposed struts or bars connected together at the proximal and distal end and further including a thin, polymeric membrane surrounding the proximal portion of the implant.

"FIG. 18 illustrates a side view of an expanded embolic implant still connected to its delivery catheter but with the delivery sheath retracted out of the illustration, wherein the embolic implant comprises a plurality of longitudinally disposed struts interdigitated with a plurality of partial longitudinal struts and further partially covered with a membrane.

"FIG. 19 illustrates a side view of a collapsed embolic implant attached to its delivery catheter and disposed within its delivery sheath, wherein the implant comprises a mesh.

"FIG. 20 illustrates a side view of the embolic implant of FIG. 19 wherein the sheath has been withdrawn to expose the implant allowing it to expand diametrically.

"FIG. 21 illustrates a side view of an embolic implant totally separated from its delivery catheter and sheath wherein the embolic implant comprises a plurality of longitudinal struts further comprising a plurality of serpentine segments in the center region of the longitudinal struts.

"FIG. 22 illustrates a side view of an embolic implant totally separated from its delivery catheter and sheath, wherein the implant comprises a plurality of longitudinally disposed struts in its proximal central region and a mesh in its distal central region.

"FIG. 23 illustrates a side view of an embolic implant comprising a plurality of longitudinal struts that each divide into three struts with the division point being in the central region of the implant.

"FIG. 24 illustrates a side view of an embolic implant comprising a plurality of longitudinal struts formed to generate two bulbs connected near the center of the implant in a smaller diameter region.

"FIG. 25 illustrates a side view of an embolic implant comprising a plurality of longitudinal struts interdigitated with flower petal structures formed in outline by bent struts affixed to the distal end of the implant.

"FIG. 26 illustrates a side view of an embolic implant comprising a plurality of longitudinal struts interconnected in the central region by laterally disposed bars.

"FIG. 27 illustrates a side view of an embolic implant comprising a plurality of longitudinal struts connecting a central mesh structure to the proximal and distal ends of the implant.

"FIG. 28 illustrates a side, partial breakaway, view of an embolic implant coupled to a delivery catheter by means of a threaded, releasable linkage.

"FIG. 29 illustrates a side, partial breakaway, view of an embolic implant coupled to a delivery catheter by means of a meltable linkage.

"FIG. 30 illustrates a side, partial breakaway, view of an embolic implant coupled to a delivery catheter by means of a pressurized release system.

"FIG. 31 illustrates a side, partial breakaway, view of an embolic implant coupled to a delivery catheter by means of an expandable coupler that can be decoupled by application of a vacuum within the coupler to shrink its diameter.

"FIG. 32 illustrates a side view of an embolic implant, in partial breakaway view, showing a pusher system to detach and deploy the implant."

For additional information on this patent application, see: Strauss, Brian M.; Valko, Jeffrey J.; Lenker, Jay A.; Pecor, Robert A.; Barker, Peter; Castaneda, Maricruz. Embolic Implant and Method of Use. Filed February 3, 2014 and posted June 5, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1311&p=27&f=G&l=50&d=PG01&S1=20140529.PD.&OS=PD/20140529&RS=PD/20140529

Keywords for this news article include: Reverse Medical Corporation.

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Source: Politics & Government Week


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