Expandable tissue supporting devices, such as balloon expandable stents, have been developed for implantation within a body passageway. Stents typically include columns of cells of interconnected struts, where each cell constitutes two adjacent struts joined to each other so that the struts rotate away from each other during stent deployment. The struts provide radial strength to a stent upon expansion. The stent struts and interconnections may also serve to contain pharmaceutical agents or bioactives, which are applied through known means, such as in a polymer coating, or housed in reservoirs within the struts or interconnections, to be released into the body following implantation.
As well known in the art, when a stent expands, such as by balloon expansion, the stent is subjected to various stresses and strains (hereinafter collectively “stresses”) that lead to plastic deformation of the stent components, such that upon balloon deflation the construct of the stent remains at a desired shape and size.
In addition, the deformation that occurs in certain regions of a stent to effect stent deployment has both an elastic component of strain and a plastic component of strain. Both the volume of stent material stressed, and the ratio of plastic deformation to elastic deformation in this material, largely governs the well-known phenomenon of recoil. It is, therefore, desirable to minimize the volume of material stressed and to maximize the ratio of plastic deformation to elastic deformation within this volume of material. To counter an expected large recoil, the stent often is over-expanded during implantation, which in turn can cause damage to or inflammation of the body passageway.
Stent design efforts have focused, and continue to focus, on addressing the above-mentioned undesirable phenomena associated with stent expansion. For example, stents have been designed to include stress concentration regions, for example, hinges, at selected points, which typically are small and well defined. Hinges are typically areas where the geometry has been reduced to provide that deformation occurs in that region. When a stent having stress concentration regions is expanded, the stresses are localized within these regions, which effectively lowers the volume of material stressed, thereby minimizing stresses in other regions of the stent.
One known stent design includes stress concentration regions, or hinges, at each end of a strut, such that a junction interconnecting adjacent struts includes two stress concentration regions or hinges. See, for example, U.S. Pat. No. 6,241,762 issued Jun. 5, 2001, incorporated by reference herein. Stent designs using known stainless steel or CoCr alloys typically utilize two stress concentration regions per strut, because of limitations in the stress capacity of the material. Both 316L and CoCr alloys typically used for stent manufacture possess an elongation of 40%-50% at break. If stresses during deployment of the stent are so excessive to cause a stent elongation exceeding the stent's elongation at break capacity, the stent is predisposed to cracking and failure. By allowing deformation to occur at either end of the strut, in other words, at the two hinge regions, the level of stress in each hinge region is maintained below the elongation at break capacity of the material. If a similar level of expansion between struts were attempted in only one hinge, the risk exists of exceeding the stress capacity of the material, unless the geometry of the hinge itself is increased sufficiently to reduce the stress levels in the hinge. Conversely, the amount of deformation between struts could be reduced to lower stress levels appropriate for these materials. More struts, however, would be needed to achieve the desired deployment diameter and, thus, more material would be implanted in the body, which is not necessarily desirable.
Hinge regions occupy volume within the stent structure and, consequently, decrease the volume of stent material available for the fabrication of struts, which provide the radial strength and drug delivery functionalities to the stent. Thus, the number of hinges in a column of cells within a stent impacts the geometry of the struts included within the column and, as a result, the strength and drug delivery capacity of the cell column and ultimately the stent itself.
Another stent design that has been developed includes a single stress concentration region, or hinge, within a strut. See, for example, U.S. Pat. No. 6,764,507, issued Jul. 20, 2004 and incorporated by reference herein in its entirety. In such single concentration region within a strut configuration, the material from which the hinge (concentration region) can be fabricated constitutes a limitation upon the amount of stress the hinge can absorb. Based on the materials presently known in the art for fabricating stents, the hinges of a stent having a single concentration region within a strut configuration can only withstand about the same level of stress as the hinges of prior art stents having a two stress concentration region per strut junction configuration. Therefore, to achieve the same expansion angle between struts, the axial length of hinges of prior art stents having a single concentration region within a strut configuration needs to be sufficiently increased, so as to limit higher levels of plastic deformation from the increased concentration of stresses at the single hinges during expansion from causing device failure. This increase in length causes the hinges in the prior art stents with a single concentration region within strut configuration to be longer in length than the hinges of stents having a two concentration region per strut junction configuration. The necessity to increase the axial length of the hinges in a stent, in turn, increases the volume of material used by hinges in a stent, which as discussed above is not desirable.
Accordingly, there exists a need for a balloon expandable tissue supporting device that concentrates stresses on a reduced volume of material in the device and avoids the application of stresses to regions in the device whose desired functionalities can become impaired when subjected to undue stresses.
USPTO Backgrounds
USPTO Backgrounds