Implants, methods of manufacturing the same, and devices and methods for delivering the implants to a vascular disorder of a patient

#In various embodiments, the present invention relates to devices and methods for providing non-invasive therapy to cerebral aneurysms and/or other similar vascular disorders in which an implant (e.g., an embolic micro-coil) is controllably delivered to a lesion and mechanically detached through actuation of a built-in detachment handle/cutting mechanism. In other embodiments, the invention relates to implantable assemblies and, specifically, to a junction connecting a polymeric stretch resistant member to an implantable device (e.g., an embolic micro-coil), as well as to methods of manufacture.

#A cerebral aneurysm (i.e., an acute subarachnoid hemorrhage) is a cerebrovascular swelling on the wall of an artery that develops because of a congenitally weak cerebral artery or due to arteriosclerosis, a bacterial infection, a head wound, brain syphilis, etc. The cerebral aneurysm may develop suddenly without initial symptoms, and can cause extreme pain. In general, in 15% of cerebral aneurysm cases, the patient dies suddenly upon development of the cerebral aneurysm. In another 15% of cerebral aneurysm cases, the patient dies under medical treatment; and in 30% of cerebral aneurysm cases, the patient survives after treatment but feels an acute aftereffect. As such, a cerebral aneurysm is a very concerning development.

#A cerebral aneurysm may be treated through either an invasive therapy or a non-invasive therapy. Of these, the non-invasive therapy typically fills the cerebral aneurysm with a micro-coil. Generally, filling the cerebral aneurysm with the micro-coil causes blood to clot, prevents an additional inflow of blood, and decreases the risk of a ruptured aneurysm (i.e., an embolization). Advantageously, the non-invasive therapy can ease the aftereffects of brain surgery and can shorten hospitalization time.

#In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which:

#FIG. 1 schematically illustrates various components at a distal portion of a delivery device in accordance with one embodiment of the invention;

#FIG. 2 schematically illustrates a portion of the delivery device's delivery pusher in accordance with one embodiment of the invention;

#In broad overview, embodiments of the present invention feature a device for delivering an implant (e.g., an embolic coil) to a vascular disorder of a patient, such as a cerebral aneurysm. The overall delivery device 100 is shown at the bottom of each of FIGS. 1-6. In addition, in each of FIGS. 1-6, a portion of the overall delivery device 100 is delineated in phantom, and that delineated portion is depicted in greater detail above the depiction of the overall delivery device 100.

#As shown in FIG. 1, an embolic coil 104 is attached to a delivery pusher 108 of the delivery device 100. The delivery pusher 108 contains, within a lumen thereof, a retractable release wire 112. As shown in FIGS. 7A-10B, in one embodiment the embolic coil 104 includes a primary coil (see FIGS. 7A-7B and 9A-9B) wound from metallic wire (preferably Platinum 8% Tungsten) that is heat set into a secondary coil shape (see FIGS. 8A-8B and 10A-10B). The embolic coil 104 is made stretch resistant by melting a ball 704 of polymer (preferably monofilament polypropylene) suture 708 at a distal end 712 of the coil 104 and threading the suture 708 through a proximal end 716 of the primary coil 104. The suture 708 is preferably sized so as to have a United States Pharmacopeia (“USP”) 9-0 suture designation, which means that the suture 708 typically has a diameter between 0.0012″ and 0.0017″. In other configurations, however, the suture 708 may be smaller or larger and/or be made of other polymers. As shown in FIGS. 9A-9B and 10A-10B, the suture 708 may be doubled through the inside diameter of the primary coil or, as shown in FIGS. 7A-7B and 8A-8B, only a single strand of the suture 708 may extend through the primary coil. The termination of the double suture configuration can be a knot 904 created between the two strands within the inside diameter of the primary coil. In either the single or double suture configuration, the preferred design is to have only a single strand exiting the primary coil inside diameter into the delivery pusher 108 as it is desirable to only sever a single strand during detachment actuation. Alternate designs for connecting the coil to the delivery pusher are discussed further below.

#The delivery pusher 108 includes a proximal shaft 304 (see FIGS. 3-6) and a flexible distal shaft 116 (see FIGS. 1-3). The proximal shaft 304 may be made from rigid, metal hypotube, preferably 300 series stainless steel with a wall thickness of about 0.002″ to provide good pushability during coil 104 delivery and stability during detachment actuation. The flexible distal shaft 116 includes a flexible inner shaft 120 made from a rigid thin-walled polymer (preferably PEEK with a wall thickness of about 0.001″), a flexible outer shaft 204 made from a rigid thin-walled polymer (preferably PEEK with a wall thickness of about 0.001″), and an anti-elongation component 208 (made preferably from 300 series stainless steel ribbon).