The assignee for this patent application is
Reporters obtained the following quote from the background information supplied by the inventors: "This invention relates to methods of treatment of blood vessels with polymeric medical devices, in particular, stent scaffolds.
"This invention relates to radially expandable endoprostheses, that are adapted to be implanted in a bodily lumen. An 'endoprosthesis' corresponds to an artificial device that is placed inside the body. A 'lumen' refers to a cavity of a tubular organ such as a blood vessel. A stent is an example of such an endoprosthesis. Stents are generally cylindrically shaped devices that function to hold open and sometimes expand a segment of a blood vessel or other anatomical lumen such as urinary tracts and bile ducts. Stents are often used in the treatment of atherosclerotic stenosis in blood vessels. 'Stenosis' refers to a narrowing or constriction of a bodily passage or orifice. In such treatments, stents reinforce body vessels and prevent restenosis following angioplasty in the vascular system. 'Restenosis' refers to the reoccurrence of stenosis in a blood vessel or heart valve after it has been treated (as by balloon angioplasty, stenting, or valvuloplasty) with apparent success.
"Stents are typically composed of scaffolding that includes a pattern or network of interconnecting structural elements or struts, formed from wires, tubes, or sheets of material rolled into a cylindrical shape. This scaffold or scaffolding gets its name because it physically holds open and, if desired, expands the wall of the passageway. Typically, stents are capable of being compressed or crimped onto a catheter so that they can be delivered to and deployed at a treatment site.
"Delivery includes inserting the stent through small lumens using a catheter and transporting it to the treatment site. Deployment includes expanding the stent to a larger diameter once it is at the desired location. Mechanical intervention with stents has reduced the rate of acute closure and restenosis as compared to balloon angioplasty.
"Stents are used not only for mechanical intervention but also as vehicles for providing biological therapy. Biological therapy uses medicated stents to locally administer a therapeutic substance. The therapeutic substance can also mitigate an adverse biological response to the presence of the stent. A medicated stent may be fabricated by coating the surface of either a metallic or polymeric scaffold with a bioresorbable polymeric carrier that includes an active or bioactive agent or drug. Polymeric scaffolding may also serve as a carrier of an active agent or drug by incorporating a drug throughout the scaffolding material.
"The stent must be able to satisfy a number of mechanical requirements. The stent must have sufficient radial strength so that it is capable of withstanding the structural loads, namely radial compressive forces, imposed on the stent as it supports the walls of a vessel. This structural load will change as a function of time as the vessel heals, undergoes positive remodeling, or adapts to the presence of the stent. Once expanded, the stent must adequately provide lumen support during a time required for treatment in spite of the various forces that may come to bear on it, including the cyclic loading induced by the beating heart. In addition, the stent must possess sufficient flexibility with a certain resistance to fracture.
"Stents implanted in coronary arteries are primarily subjected to radial loads, typically cyclic in nature, which are due to the periodic contraction and expansion of vessels as blood is pumped to and from a beating heart. Stents implanted in peripheral blood vessels, or blood vessels outside the coronary arteries, e.g., iliac, femoral, popliteal, renal and subclavian arteries, however, can undergo significant nonpulsatile forces and must be capable of sustaining both radial forces and crushing or pinching loads. These stent types are implanted in vessels that are closer to the surface of the body, and may be close to joints. Because these stents are close to the surface of the body, they are particularly vulnerable to crushing or pinching loads, which can partially or completely collapse the stent and thereby block fluid flow in the vessel.
"The superficial femoral artery (SFA), in particular, can subject a scaffold to various nonpulsatile forces, such as radial compression, torsion, flexion, and axial extension and compression, which place a high demand on the mechanical performance of implants.
"Thus, in addition to high radial strength, stents or scaffolds for peripheral vessels such as the SFA, require a high degree of crush recovery. The term 'crush recovery' is used to describe how the scaffold recovers from a pinch or crush load, while the term 'crush resistance' is used to describe the minimum force required to resist a permanent deformation of a scaffold.
"Stents made from biostable or non-bioerodible materials, such as metals, have become the standard of care for percutaneous coronary intervention (PCI) as well as in peripheral applications, such as the superficial femoral artery (SFA), since such stents have been shown to be capable of preventing early and late recoil and restenosis. In the SFA, where the artery undergoes extensive movement, self expanding stents made from materials such as Nitinol are the standard of care.
"However, in many treatment applications, the presence of a stent in a body is necessary for a limited period of time until its intended function of, for example, maintaining vascular patency and/or drug delivery is accomplished. Moreover, it is believed that biodegradable scaffolds allow for improved healing of the anatomical lumen since they allow the vessel to return to its natural state as compared to metal stents, which may lead to a reduced incidence of late stage thrombosis. In these cases, there is a desire to treat a vessel using a polymer scaffold, in particular a bioerodible polymer scaffold, as opposed to a metal stent, so that the prosthesis's presence in the vessel is for a limited duration.
"There are numerous challenges to overcome when developing a polymer scaffold, particularly in peripheral blood vessels, or blood vessels outside the coronary arteries in which a stent is subjected to both radial forces and nonpulsatile forces. One way of addressing the adverse effects of nonpulsatile forces is to implant stents as a series of disconnected segments. In this way, the transmission of nonpulsatile forces along the stent are reduced or eliminated."
In addition to obtaining background information on this patent application, VerticalNews editors also obtained the inventors' summary information for this patent application: "Embodiments of the present invention include a segmented scaffold comprising: two or more radially expandable disconnected scaffold segments arranged end to end, wherein each segment includes two or more undulating cylindrical rings composed of struts, and wherein rings at an end of each segment comprise peak undulations projecting longitudinally outward from the end of the segment and comprise valley undulations extending longitudinally toward the segment, and wherein the peak and valley undulations of adjacent rings overlap.
"Embodiments of the present invention include a method of delivering a scaffold: providing a segmented scaffold crimped over a delivery balloon, the segmented scaffold comprising two or more radially expandable disconnected scaffold segments arranged end to end, wherein each end of the segments comprises undulating cylindrical rings composed of struts and wherein undulations of adjacent segments overlap; and expanding the scaffold segments to a deployment diameter, wherein the undulations of the adjacent segments overlap at the deployed diameter.
"Embodiments of the present invention include a radially expandable scaffold segment comprising: two or more connected undulating cylindrical rings composed of struts, wherein the undulating rings of each segment form a plurality of diamond-shaped cells with two pairs of opposing vertices, one pair being longitudinally aligned and one pair being circumferentially aligned, and wherein alternating diamonds around at least one end ring are omitted to form peak and valley undulations along the at least one end ring with a longitudinal length that is a longitudinal length of the diamond-shaped cells.
"Embodiments of the present invention include a scaffold comprising: a plurality of scaffold segments in a crimped reduced configuration; and at least one discontinuous linking element between adjacent segments comprising a discontinuity located between the adjacent segments.
"Embodiments of the present invention include a method of modifying a scaffold comprising: providing a scaffold in a crimped reduced configuration, wherein the scaffold comprises longitudinal scaffold segments and linking elements connecting adjacent scaffold segments; and creating a discontinuity in at least one linking element between at least one set of adjacent segments."
For more information, see this patent application: Papp, John E.; Hossainy,
Keywords for this news article include: Surgery, Therapy, Treatment, Cardiology, Restenosis, Heart Disease, Risk and Prevention, Surgical Technology,
Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC
Most Popular Stories
- Dmytro Firtash, Ukrainian Billionaire, Arrested in Vienna
- Obama, Ukraine Discuss Russian Incursion in Crimea
- Koch Brothers Step up Anti-Obamacare Campaign
- Obama's Overtime Initiative Praised, Condemned
- FDIC Sues Big Banks Over Rate Manipulation
- Liberty Media Drops Sirius Bid
- Republicans Warn Obama on Immigration
- Uli Hoeness, Bayern Munich President, Gets Prison for Tax Evasion
- West Readies Harsh Sanctions Against Russia
- Calumet Photo Files for Bankruptcy