Patent Grant
8961590
1. Field of the Invention
The present invention relates to tissue-supporting medical devices and drug delivery systems, and more particularly to expandable devices that are implanted within a body lumen of a living animal or human to support the organ, maintain patency and/or deliver drugs or agents.
2. Summary of the Related Art
In the past, permanent or biodegradable devices have been developed for implantation within a body passageway to maintain patency of the passageway and/or locally deliver drug or agent. These devices are typically introduced percutaneously, and transported transluminally until positioned at a desired location. These devices are then expanded either mechanically, such as by the expansion of a mandrel or balloon positioned inside the device, or expand themselves by releasing stored energy upon actuation within the body. Once expanded within the lumen, these devices, typically referred to as stents, become encapsulated within the body tissue and remain a permanent implant.
Known stent designs include monofilament wire coil stents (U.S. Pat. No. 4,969,458); welded metal cages (U.S. Pat. Nos. 4,733,665 and 4,776,337); and, most prominently, thin-walled metal cylinders with axial slots formed around the circumference (U.S. Pat. Nos. 4,733,665, 4,739,762, and 4,776,337). Known construction materials for use in stents include polymers, organic fabrics and biocompatible metals, such as, stainless steel, gold, silver, tantalum, titanium, cobalt chromium and shape memory alloys such as Nitinol.
U.S. Pat. Nos. 4,733,665, 4,739,762, and 4,776,337 disclose expandable and deformable interluminal vascular grafts in the form of thin-walled tubular members with axial slots allowing the members to be expanded radially outwardly into contact with a body passageway. After insertion, the tubular members are mechanically expanded beyond their elastic limit and thus permanently fixed within the body. The force required to expand these tubular stents is proportional to the thickness of the wall material in a radial direction. To keep expansion forces within acceptable levels for use within the body (e.g., 5-10 atm), these designs must use very thin-walled materials (e.g., stainless steel tubing with 0.0025 inch thick walls). However, materials this thin are not visible on conventional fluoroscopic and x-ray equipment and it is therefore difficult to place the stents accurately or to find and retrieve stents that subsequently become dislodged and lost in the circulatory system.
Further, many of these thin-walled tubular stent designs employ networks of long, slender struts whose width in a circumferential direction is two or more times greater than their thickness in a radial direction. When expanded, these struts are frequently unstable, that is, they display a tendency to buckle, with individual struts twisting out of plane. Excessive protrusion of these twisted struts into the bloodstream has been observed to increase turbulence, and thus encourage thrombosis. Additional procedures have often been required to attempt to correct this problem of buckled struts. For example, after initial stent implantation is determined to have caused buckling of struts, a second, high-pressure balloon (e.g., 12 to 18 atm) would be used to attempt to drive the twisted struts further into the lumen wall. These secondary procedures can be dangerous to the patient due to the risk of collateral damage to the lumen wall.
In addition, many of the known stents display a large elastic recovery, known in the field as “recoil,” after expansion inside a lumen. Large recoil necessitates over-expansion of the stent during implantation to achieve the desired final diameter. Over-expansion is potentially destructive to the lumen tissue. Known stents of the type described above experience recoil of up to about 6 to 12% from maximum expansion.
Large recoil also makes it very difficult to securely crimp most known stents onto delivery catheter balloons. As a result, slippage of stents on balloons during interlumenal transportation, final positioning, and implantation has been an ongoing problem. Many ancillary stent securing devices and techniques have been advanced to attempt to compensate for this basic design problem. Some of the stent securing devices include collars and sleeves used to secure the stent onto the balloon.
Another problem with known stent designs is non-uniformity in the geometry of the expanded stent. Non-uniform expansion can lead to non-uniform coverage of the lumen wall creating gaps in coverage and inadequate lumen support. Further, over expansion in some regions or cells of the stent can lead to excessive material strain and even failure of stent features. This problem is potentially worse in low expansion force stents having smaller feature widths and thicknesses in which manufacturing variations become proportionately more significant. In addition, a typical delivery catheter for use in expanding a stent includes a balloon folded into a compact shape for catheter insertion. The balloon is expanded by fluid pressure to unfold the balloon and deploy the stent. This process of unfolding the balloon causes uneven stresses to be applied to the stent during expansion of the balloon due to the folds causing the problem non-uniform stent expansion.
It is desirable to provide flexibility in stents to facilitate introduction of the stent into vessels that are difficult to reach. Often, however, characteristics of the stent that provide longitudinal flexibility, which is desirable when introducing the stent into the vessel, can be disadvantageous in terms of keeping the stent in an expanded condition. For example, stents formed from interconnected rings with closed cell structures or generally diamond-shaped cells are typically less flexible than stents formed from one or more helices, but are usually more uniformly and consistently expandable than helical stents. It is desirable to provide a stent with substantial flexibility that is adapted to be expanded in a uniform and consistent fashion.
In WO 03/015664, which is incorporated by reference, a stent having interconnected struts with openings for drug delivery is disclosed. However, elements for bridging the struts are generally thinner and spaced further apart than the struts. Thus, for such drug-eluting stents, the bridging element can provide an area of reduced or less consistent drug delivery. It is desirable to provide a drug-eluting stent in which areas of reduced or less consistent drug delivery can be reduced.
The present invention relates to tissue-supporting medical devices and drug delivery systems, and more particularly to expandable, devices that are implanted within a body lumen of a living animal or human to support the organ, maintain patency and/or deliver drugs or agents.
In one embodiment of the invention the flexible stent has proximal and distal end portions and a cylindrical shape, with luminal and abluminal surfaces and a thickness there between. The cylindrical shape defines a longitudinal axis. The stent further comprises a proximal helical section, a distal helical section and an intermediate ring section there between, each of the proximal and distal helical sections having of a plurality of longitudinally oriented strut members and a plurality of circumferentially oriented hinge members connecting circumferentially adjacent strut members to form a band, the band being wrapped about the longitudinal axis in a substantially helical manner to form a plurality of helical windings. The distal helical section is wound about the longitudinal axis in the opposite direction from the proximal helical section. The intermediate ring section includes a plurality of longitudinally oriented strut members and a plurality of circumferentially oriented hinge members connecting circumferentially adjacent strut members to form an endless ring. The intermediate ring section is attached to the distal end of the proximal helical section and the proximal end of the distal helical section by at least one connector members.
The stent of the present invention is very flexible and deliverable, while still providing sufficient radial strength to maintain vessel patency. The stent can be formed in any suitable manner, such as by laser cutting a tube made from a suitable material, including cobalt chromium alloys, stainless steel alloys or nickel titanium alloys. Although coronary flexible stents of the present invention are disclosed to illustrate one embodiment of the present invention, one of ordinary skill in the art would understand that the disclosed invention can be equally applied to other locations and lumens in the body, such as, for example, vascular, non-vascular and peripheral vessels, ducts, and the like.
In accordance with one aspect of the present invention, the flexible stent is designed to be crimped down to a reduced diameter and percutaneously delivered through a body lumen to a target site by a delivery catheter. The target site may be, for example, a cardiac artery. Once deployed the flexible stent functions to maintain vessel patency and, if desired, deliver controlled amounts of drug or agent.
Perspective views of a flexible stent 100 in the expanded (deployed), crimped, and “as cut” or manufactured state according to one embodiment of the present invention are illustrated in
The flexible stent 100 is cylindrical with a tubular configuration of structural elements having luminal and abluminal surfaces, 101, 102 respectively, and thickness (wall thickness) “T” there between. The cylindrical shape of the stent defines a longitudinal axis 103 and has proximal and distal ends portions 104, 105 respectively.
The terms proximal and distal are typically used to connote a direction or position relative to a human body. For example, the proximal end of a bone may be used to reference the end of the bone that is closer to the center of the body. Conversely, the term distal can be used to refer to the end of the bone farthest from the body. In the vasculature, proximal and distal are sometimes used to refer to the flow of blood to the heart, or away from the heart, respectively. Since the flexible stent described in this invention can be used in many different body lumens, including both the arterial and venous system, the use of the terms proximal and distal in this application are used to describe relative position in relation to the direction of delivery. For example, the use of the term distal end portion in the present application describes the end portion of the stent first introduced into the vasculature and farthest from the entry point into the body relative to the delivery path. Conversely, the use of the term proximal end portion is used to describe the back end portion of the stent that is closest to the entry point into the body relative to the delivery path.
The stent 100 architecture generally includes ring-like end sections 106, 107 along the proximal and distal ends, 104, 105 respectively, and a helical interior section 108 there between. The helical interior section 108 further includes a central zone 111 and proximal and distal transition zones 109, 110 respectively. The transition zones 109, 110 transition between the central zone 111 and the proximal and distal ring-like end sections 106, 107.
The stent 100 includes a plurality of longitudinally oriented struts 113 connected by a series of circumferentially oriented ductile hinges 114. Circumferentially adjacent struts 113 are connected at opposite ends by the hinges 114 in a substantially S or Z shaped sinusoidal-like pattern to form a band. Flexible connectors 112 are distributed throughout the stent 100 architecture for structural stability under a variety of loading conditions. The stent design illustrated in
The region in the stent 100 where the interior helical section 108 is first connected to the ring-like end sections 106, 107 is referred to as an anchor point, and the hinge 114 at that location is referred to as an “anchor hinge”. This “take off” point may vary based on design constraints. Additionally, the incident angle, strut thickness, strut width, hinge width, hinge length, depot position and size, and connection length may vary based on optimization and design constraints.
As used herein the terms longitudinally, circumferentially and radially oriented are known to denote a particular direction relative to the stent 100 and the longitudinal axis 103. A longitudinally oriented member is directed, end to end (along its axis), generally in the direction of the longitudinal axis 103. It is obvious after reviewing the figures that the longitudinal direction of the strut 113 is closer to being parallel to the longitudinal axis when the stent 100 is in the crimped state as illustrated in
The struts 113 may have one or more depots 117 for containing at least one agent. The depots 117 may be any form of recess, channel, hole or cavity capable of holding an agent, but are preferably through holes precisionly formed through the stent 100. In a preferred embodiment, the through hole passes through the strut from the luminal to abluminal surface. This preferred configuration may allow an agent or agents to be delivered both in a radially inward and outward direction along the luminal and abluminal sides of the stent 100. In addition, the depots 117 may be filled with a polymer inlay, either alone or containing one or more agents in solution or otherwise. Various depots 117 in the same stent may be filled with the same or different agents, and may have the same or different concentrations of agents. Any individual depot 117 may be filed with one or multiple agents, and the agents may be separated by a barrier layer. The barrier layer may be position in various configurations in the depot 117 as need to separate the agents. In a preferred embodiment, the barrier layer is oriented parallel to the luminal stent surface.
The struts 113 may have symmetrically sized depots 117 as illustrated in
As the term is used herein, the agent can be any therapeutic or pharmaceutic agent or drug, including the following: antiproliferative/antimitotic agents including natural products such as vinca alkaloids (i.e. vinblastine, vincristine, and vinorelbine), paclitaxel, epidipodophyllotoxins (i.e. etoposide, teniposide), antibiotics (dactinomycin (actinomycin D) daunorubicin, doxorubicin and idarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin (mithramycin) and mitomycin, enzymes (L-asparaginase which systemically metabolizes L-asparagine and deprives cells which don't have the capacity to synthesize their own asparagine; antiproliferative/antimitotic alkylating agents such as nitrogen mustards (mechlorethamine, cyclophosphamide and analogs, melphalan, chlorambucil), ethylenimines and methylmelamines (hexamethylmelamine and thiotepa), alkyl sulfonates-busulfan, nitrosoureas (carmustine (BCNU) and analogs, streptozocin), trazenes—dacarbazinine (DTIC); antiproliferative/antimitotic antimetabolites such as folic acid analogs (methotrexate), pyrimidine analogs (fluorouracil, floxuridine, and cytarabine), purine analogs and related inhibitors (mercaptopurine, thioguanine, pentostatin and 2-chlorodeoxyadenosine {cladribine}); platinum coordination complexes (cisplatin, carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide; hormones (i.e. estrogen); Anticoagulants (heparin, synthetic heparin salts and other inhibitors of thrombin); fibrinolytic agents (such as tissue plasminogen activator, streptokinase and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab; antimigratory; antisecretory (breveldin); anti-inflammatory: such as adrenocortical steroids (cortisol, cortisone, fludrocortisone, prednisone, prednisolone, 6α-methylprednisolone, triamcinolone, betamethasone, and dexamethasone), non-steroidal agents (salicylic acid derivatives i.e. aspirin; para-aminophenol derivatives i.e. acetominophen; Indole and indene acetic acids (indomethacin, sulindac, and etodalac), heteroaryl acetic acids (tolmetin, diclofenac, and ketorolac), arylpropionic acids (ibuprofen and derivatives), anthranilic acids (mefenamic acid, and meclofenamic acid), enolic acids (piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone), nabumetone, gold compounds (auranofin, aurothioglucose, gold sodium thiomalate); immunosuppressive: (cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine, mycophenolate mofetil); angiogenic: vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF); nitric oxide donors; anti-sense oligo nucleotides and combinations thereof.
One or more agents may be distributed in one or more of the depots 117, along at least a portion of the luminal or abluminal stent 100 surfaces, or any combination of depots and/or stent surfaces. In a preferred embodiment, the agent is distributed in the depots 117 only, such that the exposed agent surface area is limited to the cross-sectional area of the depot opening in the stent 100 surface (luminal, abluminal or both). This design allows for agent delivery from the stent 100 having a surface area upon insertion into the patient that is substantially bare metal. In a preferred embodiment, the exposed bare metal surface area of the stent 100 is between 40 and 95 percent upon insertion of the stent 100 into a patient, and is most preferably approximately 75 percent bare metal upon insertion of the stent 100 into a patient. That is, the surface area of the stent 100 is approximately 25 percent agent and approximately 75 percent bare metal. As the agent is released, the stent 100 becomes a purely bare metal stent.
In a preferred embodiment, the depots 117 are distributed nearly uniformly throughout the strut pattern to provide a consistent agent dosage per unit surface area of the deployed stent 100 independent of the diameter or length of the stent used. The struts 113 may be of varying lengths, incident angle, depot configuration, and widths as needed to meet the product design.
Ductile hinges 114 are used as the connection element between two circumferentially adjacent struts 113. There are two types of ductile hinges 114 found in stent 100.
Generally speaking, the ductile hinges 114 are deformable elements that are substantially thinner in width than the surrounding struts 113. This allows the ductile hinges 114 to sustain plastic deformation while still remaining flexible in the deformed state. The struts 113 are therefore much stiffer than the ductile hinges 114, and thus do not experience any plastic deformation during stent expansion. The struts 113 essentially rotate as rigid bodies, while the ductile hinges 114 are designed to the bear the plastic strains associated with stent expansion. As a result, the depots 117 in the struts 113 are shielded from undue stress during expansion that may cause damage or dislodgement of the agents and/or polymer inlays. The depots 117 are ideally in a stress-free state throughout the stent deployment process.
In a preferred embodiment of the present invention, the ductile hinges 114 are optimized, through the use of width tapering, such that they offer sufficient radial stiffness to the stent 100 while simultaneously ensuring that peak plastic strains at full expansion do not exceed the strain carrying capability of the material. This width tapering is optimized, for each hinge 114 type, to achieve a smooth and uniform distribution of plastic strains along the length of the ductile hinge 114. By smoothing the strain distribution and thus eliminating strain concentrations in the ductile hinge 114, the width, and thereby stiffness, is maximized. Maximizing the stiffness of the ductile hinge 114 is advantageous in providing radial stiffness and fatigue durability for the stent 100.
In general the width of the tapered ductile hinge 114 gradually increases while approaching the root of the hinge 114, where the hinge 114 meets an abrupt transition into the wider strut 113 (or stiffer structure). This prevents plastic strains from concentrating at the roots of the hinges since the tapered hinge root is stiffer and therefore distributes plastic strain to the central portion of the hinge 114. The central portion of the ductile hinge 114, which encompasses the apex of the curve, generally has a uniform width. Turning again to
Between the ring-like end sections 106, 107 lies the interior helical section 108 of the stent 100, where the band of sinusoidally arranged struts 113 and hinges 114 follow a helical path. The helical band of the interior section 108 is achieved by arranging the struts 113 in a repeating pattern of alternating short and long lengths. The helical interior section 108 may be further divided into proximal and distal transition zone 109, 110 respectively, and a central zone 111.
The central zone 111 comprises strings (collections of elements) formed from groups of contiguous strut members 113 and hinge members 114 organized to form a string pattern. In one embodiment of the invention, contiguous strings have different string patterns and repeating strings are geometrically symmetric to form a repeating central pattern. In a preferred embodiment of the invention, the repeating central pattern consists of two different repeating strings. The central zone 111 therefore has a constant pitch and incident angle.
As used herein the term pitch is understood to mean the number of sinusoidal turns over a given area. This is similar nomenclature to the diametral pitch of a gear. The greater the pitch, the greater the number of sinusoidal turns, i.e. the greater number of struts 113 and ductile hinges 114, will be found per wrap as the sinusoidal band winds about the longitudinal axis 103. This creates a very dense pattern of struts 113 and hinges 114. Conversely, the smaller the pitch, the smaller number of sinusoidal turns, and thus the smaller number of struts 113 and hinges 114 will be found per wrap as the sinusoidal band winds about the longitudinal axis 103. The term incident angle refers specifically to the helical winding section of the stent 100 and is understood to mean the angle at which the sinusoidal band makes (wraps) with the longitudinal axis.
The proximal and distal transition zones 109, 110 are sections of variable pitch, and in which there is no repeatability or symmetry. The proximal and distal transition zones 109, 110 are constructed so as to afford a gradual decrease in pitch in transitioning between the central zone 111 and the proximal and distal ring-like end sections 105, 107. The proximal and distal transition zones 109, 110 are connected to the proximal and distal ring-like end section 106, 107, respectively, by a connecting geometry called an anchor hinge.
The stent 100 designs depicted in the aforementioned figures are known as an open cell design, meaning that connectors between longitudinally adjacent windings of sinusoidal elements occur only intermittently through the structure rather than spanning every longitudinally adjacent hinge 114 or strut 113. A design in which every longitudinally adjacent hinge or strut is connected is known as a closed cell design. An open-celled architecture is generally more flexible than a closed-cell architecture.
As previously described, the general architecture of the stent 100 includes a helical interior section 108 with ring-like end sections 106, 107 at each end, and connectors 112 distributed through the architecture for structural stability under a variety of loading conditions. The helical interior section 108 may be further separated into a central zone 111 having a constant pitch and incident angle, and proximal and distal transition zones 109, 110 respectively. This general architecture remains the same for various stents of different sizes; however, the geometry and pattern of the elements (struts, hinges and flex connectors) may change as need to adapt to various desired stent diameters.
Each stent pattern design is customized to target optimal results based on the treatment of the stent's intended target vessel.
The current embodiment for an extra small stent includes sinusoidal proximal and distal ring-like end sections 206, 207 comprised of ten struts 213 in each ring-like end sections 206, 207. Between the ring-like end sections 206, 207 lies the interior helical section 208 of the stent 200, where the sinusoidal arrangement of struts 213 and hinges 214 follow a helical path. The helical path of the interior section 208 is achieved by arranging the struts 213 in a repeating pattern of alternating short and long lengths to form a band. There are nine struts 213 per winding in each the interior bands. The fewer number of struts allows for increased stent performance while maintaining critical processing parameters. The helical interior section 208 may be further divided into proximal and distal transition zones 209, 210 respectively and a central zone 211 as illustrated in
The central zone 211 consists of repeating strut strings, or collections of struts, which are geometrically symmetric to form a repeating pattern in the band. The central zone 211 therefore has a constant pitch and incident angle. The repeating interior pattern is comprised of two 3-strut patterns that alternate to form the 9-strut repeating interior pattern.
The current embodiment for a medium sized stent includes sinusoidal proximal and distal ring-like end sections 306, 307 comprised of twelve strut 313 end rings. Between the ring-like end sections 306, 307 lies the interior helical section 308 of the stent 300, where the sinusoidal arrangement of struts 313 and hinges 314 in the band follow a helical path. The helical path of the interior section 308 is achieved by arranging the struts 313 in a repeating pattern of alternating short and long lengths to form the band. There are thirteen struts 313 per band winding in the interior helical section 308. The increased number of struts allows for increased stent performance while maintaining critical processing parameters. The helical interior section 308 may be further divided into proximal and distal transition zones 309, 310 respectively and a central zone 311 as illustrated in
The central zone 311 consists of repeating strut strings, or collections of struts, which are geometrically symmetric to form a repeating pattern. The central zone 311 therefore has a constant pitch and incident angle. The repeating interior pattern is comprised of one 3-strut pattern and one 5-strut pattern that alternate to form the 13-strut repeating interior pattern.
The present invention also contemplates the use of solid struts in similar strut/hinge orientations as those disclosed in
Stents 100 through 500 previously depicted and described have helical interior sections 108, 208, 308, 408 and 508 respectively, of repeating longitudinally oriented struts connected by a series of circumferentially oriented ductile hinges in a substantially S or Z shaped sinusoidal-like pattern. As previously described, the helical interior section is formed by the band of sinusoidally arranged struts and hinges that follow a helical path. The helical band of the interior section 108, 208, 308, 408 and 508 is achieved by arranging the struts in a repeating pattern of alternating short and long lengths. The helical interior section 108, 208, 308, 408 and 508 may be further divided into proximal and distal transition zones and a central zone 111, 211, 311, 411, 511 respectively.
The central zones comprise strings (collections of elements) formed from groups of contiguous strut members and hinge members organized to form a string pattern. In one embodiment of the invention, contiguous strings have different string patterns and repeating strings are geometrically symmetric to form a repeating central pattern. In a preferred embodiment of the invention, the repeating central pattern consists of two different repeating strings. The central zone therefore may have a constant pitch and incident angle. Complimentary elements forming the strings and string patterns, i.e. struts and hinges in like strings, are generally uniform in size and shape.
Another inventive stent design may have one or more structural features along the intermediate section of the helical interior section to effectively interrupt the repeating central pattern in the interior section, particularly the central zone, to create a central zone with two separate helical subsections of repeating patterns, one before and one after the structural feature.
The structural feature may add more structure to the stent while retraining overall stent flexibility. When a balloon is used to mechanically expand the stent, the feature may also provide additional securement of the stent on the balloon, and reduce the risk of fore lengthening—the unintentional axial stretching the open cell design as a result of deployment. The condition is particularly prevalent if the balloon moves or pulls one end of the stent.
The structural feature may be centered along the helical section length, effectively bisecting the intermediate section into two equal subsections. Centering the structural feature offers the opportunity for symmetry of the stent, simplifying design and modeling, and allowing stent properties to remain more uniform. However, the structural feature does not need to be centrally located with the intermediate helical section, and this design should not unnecessarily limit the scope of this invention.
Various embodiments of the present invention having a structural feature are illustrated in the following figures. Like reference numerals are used to indicate similar features and elements between the featured stent and stents 100 through 500 previously described. For example, strut 113 in stent 100 is similar to strut 1113 in stent 1100.
A structural feature 1120 is located along the interior section 1108, functionally interrupting the helical pattern and effectively segregating the helical interior section 1108 into two separate subsections 1108A and 1108B. In the illustrated embodiment, the structural feature 1120 includes a helical band element 1120 having wider elements at coincident points along the element profile than the remainder of the helical section 1108. A coincident point would be the same relative point on a similar element. For example, the strut width measurement at the midpoint along the longitudinal length of a 3 depot strut in the helical band element 1120 would be wider than the strut width measurement at the midpoint along the longitudinal length of a 3 depot strut that is not in the helical band element 1120. In particular, the illustrated embodiment shows a helical band element 1120 having wider hinges 1114 and struts 1113, however, a helical band 1120 having only wider hinges 1114 or struts 1113 is also contemplated by the present invention. This helical band 1120 is stiffer, changing the expansion and flexibility characteristics of the stent. The width, size and shape of the members can be altered to “tune” the stent and achieve the desired characteristics.
The first subsection 1108A is located between the proximal ring like section 1106 and the widened helical band element 1120. The second helical subsection 1108B is located between the distal ring-like end section 1107 and the widened helical band element 1120. The helical interior section 1108 may further include a central zone 1111 and proximal and distal transition zones 1109, 1110 respectively. The transition zones 1109, 1110 transition between the central zones 1111 and the proximal and distal ring-like end sections 1106, 1107 respectively.
The central zone 1111 may include strings (collections of elements) formed from groups of contiguous strut members 1113 and hinge members 1114 organized to form a string pattern. In one embodiment of the invention, contiguous strings have different string patterns and repeating strings, and the elements that make up the string, are geometrically symmetric to form a repeating central pattern. In a preferred embodiment of the invention, the repeating central pattern consists of two different repeating strings. The central zone 1111 also includes the widened helical band element 1120. The structural feature 1120 interrupts the repeating pattern in the central zone 1111, while the remaining repeating pattern of struts and hinges continues before and after the widened helical band element 1120.
Another inventive embodiment of a structural feature that interrupts the repeating pattern in the central zone includes a section having additional connectors between adjacent helical windings.
Similar to the stents previously disclosed, there are two types of ductile hinges 1214 found in stent 1200. As described earlier,
The structural feature 1220 is located along the interior section 1208, functionally and structurally interrupting the helical pattern and effectively segregating the helical interior section 1208 into two separate subsections 1208A and 1208B. In the illustrated embodiment, the structural feature 1220 includes a helical band element having a greater number of flexible connectors 1212, i.e. a greater number of circular hinge regions 1218, than the remainder of the interior helical section 1208. That is to say the number and spacing between hinge regions 1218 is greater in the structural feature 1220 region than in the remainder of the stent. For clarity, the helical band element forming the structural feature 1220 having the denser flex connect geometry has been shaded. In particular, the illustrated embodiment shows a structural feature 1220 having flex connectors 1212 connected between hinge regions 1218 at every other circumferentially adjacent strut pair. The additional flex connectors 1212 make the structural feature 1220 stiffer than the remainder of the stent 1200, changing the expansion and flexibility characteristics of the stent. The number and spacing of the flexible connectors 1212 can be altered to “tune” the stent and achieve the desired characteristics. For example, the stent could also have a structural element 1220 where the flex connectors 1212 are connected between every longitudinally adjacent strut pair.
Referring again to
The central zone 1211 may include strings (collections of elements) formed from groups of contiguous strut members 1213 and hinge members 1214 organized to form a string pattern. In one embodiment of the invention, contiguous strings have different string patterns and repeating strings, and the elements that make up the strings, are geometrically symmetric to form a repeating central pattern. In a preferred embodiment of the invention, the repeating central pattern consists of two different repeating strings. The central zone 1211 also includes the structural feature 1220 having the denser circular hinge regions 1218. The structural feature 1220 interrupts the repeating pattern in the central zone 1211, such that the repeating pattern of struts and hinges reside before and after the structural feature 1220.
The embodiment illustrated in
Another embodiment of the invention contemplates alternating the direction of the connectors 1212 in some pattern.
In addition, the stent 1300 has a structural feature 1320, shaded for clarity, which includes additional connectors between adjacent helical windings in the central zone 1311. However, unlike the dense band of connectors 1212 forming structural feature 1220 in stent 1200, where all connectors 1212 are oriented in the same direction, the band 1320 of connectors 1312 in stent 1300 have an alternating orientation. That is circumferentially adjacent connectors 1312 alternate between forming an acute angle with the longitudinal axis to obtuse angle with the longitudinal axis. Having connectors 1312 with opposite orientations provides addition shear strengthening when needed.
Another inventive embodiment of a structural feature that interrupts the repeating pattern in the central zone includes a structural feature in the form of a ring-like central section, similar to the ring-like end sections previously described.
The stent 1400 architecture generally includes proximal and distal ring-like end sections 1406, 1407 along the proximal and distal ends 1404, 1405, respectively, and a ring-like central section 1420 located there between. The ring-like sections 1406, 1407 and 1420 are closed hoop structures in axial alignment and define the longitudinal axis. While the illustrated embodiment shows one ring-like structure at each location, the number and relative spacing between the ring-like sections should not be construed a limited factor in the present stent design.
The stent 1400 further includes at least two helical sections between the ring-like sections. In the illustrated embodiment, a first helical section 1408A is located between the proximal ring like end section 1406 and the central ring-like section 1420. A second helical section 1408B is located between the distal ring-like end section 1407 and the central ring-like section 1420. The helical interior sections 1408A, 1408B may each further include a central zone and proximal and distal transition zones.
The stent 1400 includes a plurality of longitudinally oriented struts 1413 connected by a series of circumferentially oriented ductile hinges 1414. Circumferentially adjacent struts 1413 are connected at opposite ends by the hinges 1414 in a substantially S or Z shaped sinusoidal-like pattern to form a band. The band forming the ring-like end sections 1406, 1407 and structural feature 1420 are closed rings. The bands forming the central helical sections 1408A,B are wound about the longitudinal axis in a spiral or helical fashion. Flexible connectors 1412 are distributed throughout the stent 1400 architecture for structural stability under a variety of loading conditions. The stent design illustrated in
The central zones 1411A,B may include strings (collections of elements) formed from groups of contiguous strut members 1413 and hinge members 1414 organized to form a string pattern. In one embodiment of the invention, contiguous strings have different string patterns and repeating strings, and the elements that make up the strings, are geometrically symmetric to form a repeating central pattern. In a preferred embodiment of the invention, the repeating central pattern consists of two different repeating strings.
The closed ring forming structural feature 1420 provides a more rigid central area, which allows the stent to be more securely crimped to the expansion balloon. This will improve stent deployment. The design will also reduce the risk of forelengthening during deployment, which will reduce unintended strain to the stent, create greater fracture resistance, and general aid in stent placement by maintaining the stent intended length.
Stent 1400 generally illustrates a stent architecture having a helical section 1408 wound in a distal counter-clockwise direction. That is to say when looking in a distal direction from the proximal end, the helical band is wrapped counter-clockwise around the longitudinal axis in a substantially helical manner from the proximal end 1404 of the stent towards the distal end 1405 of the stent. Another inventive stent design may have one or more helical sections wound in both a distal counter-clockwise and a distal clockwise direction.
The stent 1500 architecture generally includes proximal and distal ring-like end sections 1506, 1507 along the proximal and distal ends 1504, 1505, respectively, and a ring-like central section 1520 located there between. The ring-like sections 1506, 1507 and 1520 are closed hoop structures in axial alignment and define the longitudinal axis. While the illustrated embodiment shows one ring-like structure at each location, the number and relative spacing between the ring-like sections should not be construed a limited factor in the present stent design.
The stent 1500 further includes at least two helical sections between the ring-like sections. In the illustrated embodiment, a first helical section 1508A is located between the proximal ring like end section 1506 and the central ring-like section 1520. A second helical section 1508B is located between the distal ring-like end section 1507 and the central ring-like section 1520. As can be seen in
The helical interior sections 1508A, 1508B may each further include a central zone and proximal and distal transition zones.
The stent 1500 includes a plurality of longitudinally oriented struts 1513 connected by a series of circumferentially oriented ductile hinges 1514. Circumferentially adjacent struts 1513 are connected at opposite ends by the hinges 1514 in a substantially S or Z shaped sinusoidal-like pattern to form a band. The band forming the ring-like end sections 1506, 1507 and structural feature 1520 are closed rings. The bands forming the central helical sections 1508A,B are wound about the longitudinal axis in a spiral or helical fashion. Flexible connectors 1512 are distributed throughout the stent 1500 architecture for structural stability under a variety of loading conditions. The stent design illustrated in
The central zones 1511A,B may include strings (collections of elements) formed from groups of contiguous strut members 1513 and hinge members 1514 organized to form a string pattern. In one embodiment of the invention, contiguous strings have different string patterns and repeating strings, and the elements that make up the strings, are geometrically symmetric to form a repeating central pattern. In a preferred embodiment of the invention, the repeating central pattern consists of two different repeating strings.
This opposing helix design illustrated in the present invention improves stent retention at the ends, as well as at the center of the stent, by dampening axial and torsional deformation modes intrinsic in helical stent designs when subject to compressive load. Such axial compression of the stent is typically encountered when crossing the stent into a tight lesion, or pulling the stent back into the guide catheter.
As can be seen in
In addition, the closed ring forming structural feature 1520 provides a more rigid central area, which allows the stent to be more securely crimped to the expansion balloon. This will improve stent deployment. The design will also reduce the risk of forelengthening during deployment, which will reduce unintended strain to the stent, create greater fracture resistance, and general aid in stent placement by maintaining the stent intended length.
The stent 1500 depicted in
This application claims the benefit of U.S. Provisional Application Ser. No. 61/369,969 filed Aug. 2, 2010, which is incorporated by reference herein.
| Number | Name | Date | Kind |
|---|---|---|---|
| 4733665 | Palmaz | Mar 1988 | A |
| 4739762 | Palmaz | Apr 1988 | A |
| 4776337 | Palmaz | Oct 1988 | A |
| 4969458 | Wiktor | Nov 1990 | A |
| 5061275 | Wallsten et al. | Oct 1991 | A |
| 5102417 | Palmaz | Apr 1992 | A |
| 5741333 | Frid | Apr 1998 | A |
| 5800456 | Maeda et al. | Sep 1998 | A |
| 5807404 | Richter | Sep 1998 | A |
| 5810872 | Kanesaka et al. | Sep 1998 | A |
| 5911754 | Kanesaka et al. | Jun 1999 | A |
| 5913897 | Corso, Jr. et al. | Jun 1999 | A |
| 5922021 | Jang | Jul 1999 | A |
| 5938697 | Killion et al. | Aug 1999 | A |
| 6013854 | Moriuchi | Jan 2000 | A |
| 6033433 | Ehr et al. | Mar 2000 | A |
| 6042597 | Kveen et al. | Mar 2000 | A |
| 6059822 | Kanesaka et al. | May 2000 | A |
| 6066169 | McGuinness | May 2000 | A |
| 6096072 | Kanesaka et al. | Aug 2000 | A |
| 6106548 | Roubin et al. | Aug 2000 | A |
| 6162244 | Braun et al. | Dec 2000 | A |
| 6287336 | Globerman et al. | Sep 2001 | B1 |
| 6352552 | Levinson et al. | Mar 2002 | B1 |
| 6423091 | Hojeibane | Jul 2002 | B1 |
| 6475236 | Roubin et al. | Nov 2002 | B1 |
| 6488703 | Kveen et al. | Dec 2002 | B1 |
| 6488706 | Solymar | Dec 2002 | B1 |
| 6503270 | Richter et al. | Jan 2003 | B1 |
| 6517570 | Lau et al. | Feb 2003 | B1 |
| 6551351 | Smith et al. | Apr 2003 | B2 |
| 6569193 | Cox et al. | May 2003 | B1 |
| 6610086 | Kock et al. | Aug 2003 | B1 |
| 6652576 | Stalker | Nov 2003 | B1 |
| 6656162 | Santini, Jr. et al. | Dec 2003 | B2 |
| 6730116 | Wolinsky et al. | May 2004 | B1 |
| 6736844 | Glatt et al. | May 2004 | B1 |
| 6746479 | Ehr et al. | Jun 2004 | B2 |
| 6764506 | Roubin et al. | Jul 2004 | B2 |
| 6764507 | Shanley et al. | Jul 2004 | B2 |
| 6770088 | Jang | Aug 2004 | B1 |
| 6783543 | Jang | Aug 2004 | B2 |
| 6796999 | Pinchasik | Sep 2004 | B2 |
| 6821292 | Pazienza et al. | Nov 2004 | B2 |
| 6878162 | Bales et al. | Apr 2005 | B2 |
| 6916336 | Patel et al. | Jul 2005 | B2 |
| 6949120 | Kveen et al. | Sep 2005 | B2 |
| 7041130 | Santini, Jr. et al. | May 2006 | B2 |
| 7070590 | Santini, Jr. et al. | Jul 2006 | B1 |
| 7131993 | Gregorich | Nov 2006 | B2 |
| 7160321 | Shanley | Jan 2007 | B2 |
| 7163555 | Dinh | Jan 2007 | B2 |
| 7169175 | Cottone et al. | Jan 2007 | B2 |
| 7169179 | Shanley et al. | Jan 2007 | B2 |
| 7179289 | Shanley | Feb 2007 | B2 |
| 7264633 | Bonsignore | Sep 2007 | B2 |
| 7279664 | Weber | Oct 2007 | B2 |
| 7326241 | Jang | Feb 2008 | B2 |
| 7329276 | Smith et al. | Feb 2008 | B2 |
| 7329277 | Addonizio et al. | Feb 2008 | B2 |
| 7381217 | Tischler | Jun 2008 | B2 |
| 7442203 | Ehr et al. | Oct 2008 | B2 |
| 7540881 | Meyer et al. | Jun 2009 | B2 |
| 7556644 | Burpee et al. | Jul 2009 | B2 |
| 7637939 | Tischler | Dec 2009 | B2 |
| 7666223 | Santos et al. | Feb 2010 | B2 |
| 7682384 | Addonizio et al. | Mar 2010 | B2 |
| 7686843 | Moore | Mar 2010 | B2 |
| 7722661 | Lenz et al. | May 2010 | B2 |
| 7763067 | Bales et al. | Jul 2010 | B2 |
| 7766960 | Alexander et al. | Aug 2010 | B2 |
| 7780721 | Bales et al. | Aug 2010 | B2 |
| 7812290 | Weber | Oct 2010 | B2 |
| 7820229 | Santos et al. | Oct 2010 | B2 |
| 7824439 | Toyokawa | Nov 2010 | B2 |
| 7842083 | Shanley et al. | Nov 2010 | B2 |
| 7846198 | Hogendijk | Dec 2010 | B2 |
| 7850728 | Shanley | Dec 2010 | B2 |
| 7862607 | McDermott et al. | Jan 2011 | B2 |
| 7862608 | Hogendijk et al. | Jan 2011 | B2 |
| 7909865 | Shanley | Mar 2011 | B2 |
| 7913371 | Klocke et al. | Mar 2011 | B2 |
| 7914570 | Brown | Mar 2011 | B2 |
| 7963990 | Johnson | Jun 2011 | B2 |
| 7988723 | Beach et al. | Aug 2011 | B2 |
| 8038707 | Bales et al. | Oct 2011 | B2 |
| 8119184 | Hossainy et al. | Feb 2012 | B2 |
| 8128679 | Casey | Mar 2012 | B2 |
| 8152842 | Schlun | Apr 2012 | B2 |
| 8157858 | Goto | Apr 2012 | B2 |
| 8192483 | Nakano | Jun 2012 | B2 |
| 8202313 | Shanley et al. | Jun 2012 | B2 |
| 8221496 | Zhao | Jul 2012 | B2 |
| 8292945 | Welsh et al. | Oct 2012 | B2 |
| 8328865 | Bales et al. | Dec 2012 | B2 |
| 8333799 | Bales et al. | Dec 2012 | B2 |
| 20010007955 | Drasler et al. | Jul 2001 | A1 |
| 20020038145 | Jang | Mar 2002 | A1 |
| 20020045935 | Jang | Apr 2002 | A1 |
| 20020058990 | Jang | May 2002 | A1 |
| 20020095206 | Addonizio et al. | Jul 2002 | A1 |
| 20020116044 | Cottone et al. | Aug 2002 | A1 |
| 20030055490 | Roubin et al. | Mar 2003 | A1 |
| 20030149469 | Wolinsky et al. | Aug 2003 | A1 |
| 20030199970 | Shanley | Oct 2003 | A1 |
| 20040044400 | Cheng et al. | Mar 2004 | A1 |
| 20040054399 | Roth | Mar 2004 | A1 |
| 20040088043 | Klein | May 2004 | A1 |
| 20040088044 | Brown et al. | May 2004 | A1 |
| 20040093071 | Jang | May 2004 | A1 |
| 20040106985 | Jang | Jun 2004 | A1 |
| 20040133271 | Jang | Jul 2004 | A1 |
| 20040148012 | Jang | Jul 2004 | A9 |
| 20040149294 | Gianchandani et al. | Aug 2004 | A1 |
| 20040172123 | Lootz et al. | Sep 2004 | A1 |
| 20040225347 | Lang | Nov 2004 | A1 |
| 20040230296 | Brown et al. | Nov 2004 | A1 |
| 20040249446 | Patel et al. | Dec 2004 | A1 |
| 20040249449 | Shanley et al. | Dec 2004 | A1 |
| 20040267350 | Roubin et al. | Dec 2004 | A1 |
| 20050021130 | Kveen et al. | Jan 2005 | A1 |
| 20050033410 | Hogendijk et al. | Feb 2005 | A1 |
| 20050159807 | Bales et al. | Jul 2005 | A1 |
| 20060030934 | Hogendijk et al. | Feb 2006 | A1 |
| 20060265050 | Morris et al. | Nov 2006 | A1 |
| 20060276880 | Neuss et al. | Dec 2006 | A1 |
| 20070005126 | Tischler | Jan 2007 | A1 |
| 20070129786 | Beach et al. | Jun 2007 | A1 |
| 20080097582 | Shanley et al. | Apr 2008 | A1 |
| 20080147159 | Cottone et al. | Jun 2008 | A1 |
| 20080300674 | Jang | Dec 2008 | A1 |
| 20090254173 | Jang | Oct 2009 | A1 |
| 20090306766 | McDermott et al. | Dec 2009 | A1 |
| 20100004725 | Zipse et al. | Jan 2010 | A1 |
| 20100131046 | Santos et al. | May 2010 | A1 |
| 20100145433 | Anukhin et al. | Jun 2010 | A1 |
| 20100211161 | Dreher | Aug 2010 | A1 |
| 20100217380 | Donovan et al. | Aug 2010 | A1 |
| 20100222868 | Lenz et al. | Sep 2010 | A1 |
| 20100234936 | Schlun | Sep 2010 | A1 |
| 20100292777 | Meyer et al. | Nov 2010 | A1 |
| 20100331961 | Goetzen et al. | Dec 2010 | A1 |
| 20110153003 | Shanley et al. | Jun 2011 | A1 |
| 20110184507 | Fischer, Jr. et al. | Jul 2011 | A1 |
| 20110190873 | Lenz et al. | Aug 2011 | A1 |
| 20120004719 | Gregorich et al. | Jan 2012 | A1 |
| 20120016462 | Gregorich et al. | Jan 2012 | A1 |
| 20120029620 | Schroeder | Feb 2012 | A1 |
| 20120029621 | Schroeder | Feb 2012 | A1 |
| 20120029622 | Baillargeon et al. | Feb 2012 | A1 |
| 20120226346 | Boismier et al. | Sep 2012 | A1 |
| 20120303112 | Armstrong et al. | Nov 2012 | A1 |
| 20120323308 | Zhou | Dec 2012 | A1 |
| 20130035753 | Chen et al. | Feb 2013 | A1 |
| Number | Date | Country |
|---|---|---|
| 60122525 | Dec 2006 | DE |
| 1155664 | Nov 2001 | EP |
| 1296615 | Apr 2003 | EP |
| 1318768 | Jun 2003 | EP |
| 1155664 | Jul 2003 | EP |
| 1397091 | Mar 2004 | EP |
| 1296615 | Aug 2006 | EP |
| 1772114 | Apr 2007 | EP |
| 1155664 | Nov 2007 | EP |
| 1318768 | Dec 2008 | EP |
| 2111829 | Oct 2009 | EP |
| 2003534870 | Nov 2003 | JP |
| 2004508880 | Mar 2004 | JP |
| 2004528928 | Sep 2004 | JP |
| WO 0189421 | Nov 2001 | WO |
| WO 0193781 | Dec 2001 | WO |
| WO 0224109 | Mar 2002 | WO |
| WO 0189421 | Apr 2002 | WO |
| WO 0193781 | Apr 2002 | WO |
| WO 02024109 | Dec 2002 | WO |
| WO 02098326 | Dec 2002 | WO |
| WO 03015664 | Feb 2003 | WO |
| WO 03017870 | Mar 2003 | WO |
| WO 2004058100 | Jul 2004 | WO |
| WO 2008049045 | Apr 2008 | WO |
| Entry |
|---|
| International Searching Authority, Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, Oct. 4, 2011. |
| Number | Date | Country | |
|---|---|---|---|
| 20120029622 A1 | Feb 2012 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61369969 | Aug 2010 | US |
