The patent's assignee for patent number 8632584 is
News editors obtained the following quote from the background information supplied by the inventors: "It is known to treat vascoconstriction (stenoses) with stents (vascular endoprostheses, vessel props) that are inserted into the stenotic area to keep the vessel lumen open. It is further known to use such stents for closing off vessel wall ballooning (aneurysms) or fistulae.
"For the foregoing purposes, balloon-dilatable stents are traditionally used. For placement, these stents are crimped over a non-expanded balloon in a non-dilated state, moved to the treatment location by means of a catheter system and then, by expanding the balloon, dilated and thus anchored within the vessel. As there is no need for sophisticated supporting and guiding sheaths when placing balloon-dilatable stents in position, these stents can also be inserted into very fine vessels. It is, however, problematic that on account of their plastic deformability these stents can easily be compressed when external pressure is exerted on them. Another disadvantage is encountered when anchoring such a stent, by applying high pressure, the stent has to be expanded initially beyond the circumferential size it will finally have. Such an expansion beyond the required circumferential size may involve the risk of a vessel injury that may entail the formation of a thrombus.
"Further, these traditional balloon-dilatable stents, due to their structure, cannot simply be introduced through an already laid micro-catheter and advanced to the implantation site but have to be arranged in the distal area of a specially designed micro-catheter in order to be moved to the implantation location by means of a so-called pusher. This process calls for a rather sophisticated catheter technology that is difficult to handle. Additionally, a stent, once placed in position, can only be relocated or retrieved with great difficulty, if at all. After a wrongly placed stent has been dilated it can neither be relocated nor removed as a rule.
"It is further known to apply self-expanding stents that are made of shape-memory materials. These stents possess a braid-like structure and are initially introduced and moved in a collapsed state through a catheter to the destination site where they expand either due to temperature changes (thermo-memory effect) or because the mechanical force exerted by the catheter (super-elasticity) is no longer effective. Such stents, as well, require mechanisms for their introduction that are relatively expensive and space-consuming. The known super-elastic expandable stent requires the use of a supporting and guiding sheath that results in a relatively large catheter size and, what is more, also makes it difficult to introduce such stents through an already laid catheter.
"For the introduction into small-lumen intra-cranial vessels, it is furthermore known to use stents made of shape-memory materials that initially are present in the form of an elongated filament. Not until the stent exits the catheter will it assume its tubular structure due to the change in temperature or because of the compression force no longer being exerted by the catheter.
"It is known to treat aneurysms and similar diseases by using a stent consisting of two stretched out filaments that due to the mechanical constraint of a strand, are kept, by tension, in the stretched out form until when pushed out of the catheter, said constraint is removed and the strands assume the actual form of a stent. This structure enables the use of stents having shape-memory properties in vessels of very small lumen such as the intra-cranial and cerebral vessel branches."
As a supplement to the background information on this patent, NewsRx correspondents also obtained the inventors' summary information for this patent: "The present invention is directed to implants that can be introduced through traditional micro-catheters into small-lumen intra-cranial vessels, that are well placeable and relocatable, that can be moved back into the micro-catheter in case of need, and that are suited to bridge vessel ballooning and fistulae in such a manner that these can be filled with occlusion agents. Furthermore, it is desirable to provide implants capable of adapting to the vessel caliber relatively freely, i.e., not tailored to a specific vessel caliber.
"According to the present invention, a medical implant that has the form of a longitudinally open tube with interconnected strings or filaments forming a mesh structure culminating, on one side, in a tapering structure at a connection point is provided.
"An implant according to the present invention consists of a flat object that, as a result of its impressed and superimposed structure, assumes the form of a slotted tube or hose with the free edges preferably overlapping. In its volume-reduced form it continues to be present in a curled-up condition, i.e., the diameter of the implant, in a volume-reduced state, is significantly reduced in comparison to that of the superimposed structure. After the implant has been released, it assumes the structure impressed on it and expands to such an extent that the vessel surrounding the implant allows. Such an expansion in the form of an expanding spiral spring shape leads to the implant automatically adapting to the vessel caliber or lumen in such a manner that it can be applied in vessels having different calibers. In the case of narrow vessels, this results in a relatively wide overlap of the two free edges, with wider vessels this overlap is smaller or even a free gap forms which, in the event of vessel branches, is a desirable trait.
"In one aspect of the present invention, the implant is a flat or two-dimensional structure that is rolled up to form a longitudinally open object capable of establishing close contact with the wall of the vessel into which it is introduced.
"The strings or filaments taper on one side and culminate in a connection point that permits the implant to be connected to a guide wire to be easily retracted into a catheter in an event of an incorrect placement or inadequate adaptation to the implantation site so that it may be replaced by another implant or reimplanted after the catheter has been repositioned. As a result of its tapering structure, the implant entering the micro-catheter curls up more closely and again assumes its volume-reduced form with the pull force applied to the guide wire and the forces exerted via the catheter rim interacting.
"In the catheter itself, the implant is present in its volume-reduced form, resembling rolled-up wire netting. Through the action of the guide wire and when thrust forces are applied, an axial compression will be caused, and when released, the superimposed structure assumes a minor longitudinal contraction. Advantageously, the stent according to the present invention exhibits an insignificant longitudinal contraction when released in comparison to dilatable stents.
"A connection point of the medical implant situated at the end of the tapered structure serves, at the same time, as a fastening point for the guide wire, either directly or via a connecting element. In the event of a cut or expanded metal foil, this connection point represents the point where the strings of the implant converge. In the case of a mesh-like structure consisting of individual filaments, at least two filaments converge at this connection point and are connected with each other by welding or crimping.
"The connection point serves also as a connecting element or part thereof that remains attached to the implant after the guide wire has been detached from the implant. In one embodiment, this connection point is arranged within a platinum spiral or attached to it via a platinum spiral to a connecting element. The spiral may also serve as an X-ray reflecting marker for positioning purposes. In one embodiment, the connecting elements are electrolytically corrodible. Such connecting elements enable the implant, after it has been correctly positioned, to be detached from the guide wire by applying electrical energy for brief periods of time, 10 to 60 seconds, for example.
"Advantageously, the medical implant according to one embodiment of the invention does not incur a longitudinal contraction when adapting to the vessel. The longitudinally open structure, having a predetermined winding property, has no effect on the longitudinal expansion of the stent. The foil structures have been found to be remarkably true to size under the influence of thrust and tensile forces. The same applies to the warp-knitted structure and the mesh-like structure consisting of individual filaments interconnected by welding.
"In an embodiment where the superimposed structure cannot be impressed onto the implants with the help of the warp or weft knitting method or by braiding, material may be put to use that possesses shape-memory properties. For example, such materials consist of alloys containing titanium and nickel which are known by the name of Nitinol, as well as iron and copper based alloys. Shape-memory properties may be based on a stress-induced martensitic transformation or a temperature-induced martensitic transformation or may be the result of a combination of the two.
"The implants according to one embodiment of the present invention are also provided with X-ray reflecting markers that enable the positioning and implantation to be monitored. Such markers may have the form of spirals that are arranged proximally, for example, at the connection point of the strings or filaments. The X-ray reflecting markers can also be arranged at the distal end of the implant, in the form of platinum or platinum/iridium elements incorporated in or attached to the mesh structure. The meshes of the implant, according to one embodiment the invention, may, at the distal end, be provided with a lug or end in a lug that accommodates the marker element arranged levelly.
"Furthermore, the present invention operates in a combination of the implant with a guide wire that is linked to the distal end of the implant in a manner so as to be detachable. Such detachability is brought about by an element that, under the influence of electrical energy, is capable of corroding. The guide wire can be a known and applied guiding wire of suitable kind for pushing the implant through a catheter to the site of implantation and, should it have been improperly positioned, retract it into the catheter. It is clearly understood that the corrosion point may also be in the area of the guide wire or may be based on an otherwise known mechanical or thermal detachment technique.
"The invention also relates to a system to be used for the treatment of aneurysms or other vascular malformations. The system comprises a first micro-catheter, a first guide wire to bring the first micro-catheter into position, a second guide wire to move the implant through the first micro-catheter and place it in position and the implant arranged at the distal end of the second guide wire in a way so as to be detachable. Due to the curled up structure of the implant, and as a result of making use of the combination with the guide wire, it is possible, after having placed the first micro-catheter, to remove the first guide wire and introduce and handle the second guide wire which is provided with the implant.
"As per one embodiment, the system has additionally been provided with a second micro-catheter to accommodate the second guide wire with the implant in such a way that it is slidable within the second micro-catheter and can be moved through the first micro-catheter to the target site. Coatings of the second micro-catheter that enhance its slidability may facilitate handling."
For additional information on this patent, see: Henkes, Hans; Flesser, Achim; Kontek, Ronald; Speder, Jurgen; Bodenburg, Ralph. Medical Implant Having a Curlable Matrix Structure and Method of Use. U.S. Patent Number 8632584, filed
Keywords for this news article include: Aneurysm, Treatment,
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