Patent Grant
8702781
1. Field of the Invention
The present invention relates generally to medical devices and methods. More particularly, the present invention relates to apparatus and methods for independently delivering a plurality of luminal prostheses within a body lumen, such as a blood vessel.
Coronary artery disease is the leading cause of death and morbidity in the United States and Western society. In particular, atherosclerosis in the coronary arteries can cause myocardial infarction, commonly referred to as a heart attack, which can be immediately fatal or, even if survived, can cause damage to the heart which can incapacitate the patient.
While coronary artery bypass surgery can be an effective treatment for stenosed arteries resulting from atherosclerosis or other causes, it is a highly invasive, costly procedure, which typically requires substantial hospital and recovery time. Percutaneous transluminal coronary angioplasty, commonly referred to as balloon angioplasty, is less invasive, less traumatic, and significantly less expensive than bypass surgery. Heretofore, however, balloon angioplasty has not been considered as effective a treatment as bypass surgery. The effectiveness of balloon angioplasty, however, has improved significantly with the introduction of stenting which involves the placement of a scaffold structure within the artery which has been treated by balloon angioplasty. The stent inhibits abrupt reclosure of the artery and has some benefit in inhibiting subsequent restenosis resulting from hyperplasia. Recently, experimental trials have demonstrated that the coating of stents using anti-proliferative drugs, such as paclitaxel, can significantly reduce the occurrence of hyperplasia in angioplasty treated coronary arteries which have been stented with the coated stents.
While the combination of balloon angioplasty with drug-coated stents holds great promise, significant challenges still remain. Of particular interest to the present invention, the treatment of extended or disseminated disease within an artery remains problematic. Most stents have a fixed length, typically in the range from 10 mm to 30 mm, and the placement of multiple stents to treat disease over a longer length requires the suggestive use of balloon stent delivery catheters. Moreover, it can be difficult to stent an angioplasty-treated region of a blood vessel with the optimum stent length.
For these reasons, it would be desirable to provide improved stents, stent delivery systems, stenting methods, and the like, for the treatment of patients having coronary artery disease, as well as other occlusive diseases of the vasculature. In particular, it would be desirable to provide stents, delivery systems, and methods for the treatment of disseminated and variable length stenotic regions within the vasculature. For example, it would be desirable to provide a practical method which permits a physician to optimize the length of the treated vessel which is stented according to the nature of the disease. More specifically, it would be desirable to provide apparatus, systems, and methods for facilitating the delivery of multiple stents and other prostheses to blood vessels or other target body lumens. Such apparatus, systems, and methods should be suitable for delivery of individual stents or prostheses having very short lengths, typically as short as 3 mm or shorter, at multiple contiguous and non-contiguous locations within a body lumen for optimized treatment thereof. At least some of these objectives will be met by the inventions described hereinafter.
2. Description of the Background Art
U.S. Pat. No. 6,258,117 B1 describes a stent having multiple sections connected by separable or frangible connecting regions. Optionally, the connecting regions are severed after the stent structure has been implanted in the blood vessel. U.S. Pat. Nos. 5,571,086; 5,776,141; and 6,143,016 describe an expandable sleeve for placement over a balloon catheter for the delivery of one or two stent structures to the vasculature. U.S. Pat. No. 5,697,948 describes a catheter for delivering stents covered by a sheath.
The present invention provides methods and apparatus for prosthesis placement, such as stenting of body lumens, typically blood vessels, and more typically coronary arteries. The methods and systems will also find significant use in the peripheral vasculature, the cerebral vasculature, and in other ducts, such as the biliary duct, the fallopian tubes, and the like. The terms “stent” and “stenting” are defined to include any of the wide variety of expandable prostheses and scaffolds which are designed to be intraluminally introduced to a treatment site and expanded in situ to apply a radially outward force against the inner wall of the body lumen at that site. Stents and prostheses commonly comprise an open lattice structure, typically formed from a malleable or elastic metal. When formed from a malleable metal, the stents will typically be expanded by a balloon which causes plastic deformation of the lattice so that it remains opened after deployment. When formed from an elastic metal, including super elastic metals such as nickel-titanium alloys, the lattice structures will usually be radially constrained when delivered and deployed by releasing the structures from such radial constraint so that they “self-expand” at the target site. When the stent or lattice structures are covered with a fabric or polymeric membrane covering, they are commonly referred to as grafts. Grafts may be used for the treatment of aneurysms or other conditions which require placement of a non-permeable or semi-permeable barrier at the treatment site. The terms “prosthesis” and “prostheses” refer broadly to all radially expansible stents, grafts, and other scaffold-like structures which are intended for deployment within body lumens.
The stents and prostheses of the present invention may have any of a variety of common constructions, including helical structures, counterwound helical structures, expandable diamond structures, serpentine structures, or the like. Such conventional stent structures are well described in the patent and medical literature. Specific examples of suitable stent structures are described in the following U.S. patents, the full disclosures of which are incorporated herein by reference: U.S. Pat. Nos. 6,315,794; 5,980,552; 5,836,964; 5,527,354; 5,421,955; 4,886,062; and 4,776,337, the full disclosures of which are incorporated herein by reference. Preferred structures are described herein with reference to
According to the present invention, the stents which are deployed may have a length of 1 mm or greater, usually 2 mm or greater, and typically of 3 mm or greater, usually being in the range from 1 mm to 100 mm, typically from 2 mm to 50 mm, more typically from 2 mm to 25 mm, and usually from 3 mm to 20 mm. The use of such short stent lengths is advantageous since multiple stents are to be employed.
The methods and apparatus of the present invention will provide for the deployment of a plurality of stents or other prostheses, usually including at least two stents, from a common stent delivery catheter. Usually, the number of delivered stents will be in the range from 2 to 50, typically from 3 to 30, and most typically from 5 to 25. As more stents are placed on the delivery catheter, the individual stent length will often be somewhat less, although this is not necessarily the case in all instances. The multiple prostheses may be deployed individually or in groups of two or more at single or multiple spaced-apart locations in the body lumen or lumens.
In a first aspect of the present invention, a method for stenting an extending length of a body lumen comprises introducing a catheter carrying a plurality of, usually at least two, discrete stents to the body lumen. Usually, the introduction is percutaneous and, in the case of intravascular delivery, uses a conventional introduction technique, such as the Seldinger technique. After reaching a target location, at least a first stent is released from the catheter at that first location. The catheter is then repositioned to a second location, and at least a second stent is released from the catheter at the second location. The catheter is then repositioned to a third location, and at least a third stent is released from the catheter at the third location
In addition to deploying stents and other prostheses at spaced-apart locations within a blood vessel or other body lumen, the methods and apparatus in the present invention can be used for delivering one, two, three, or more discrete stents or other prosthesis segments contiguously at a single location within the body lumen. In this way, the length of the prosthesis which is implanted can be selected and modified to accommodate the length of the vessel to be treated. It will be appreciated that with systems which carry 10, 20, 30 or more quite short prostheses or prosthesis segments, the length of the lumen being treated can be tailored very closely from very short to very long with the selectable intervals depending on the length of the prosthesis or prosthesis segment.
The deployment steps can, of course, be repeated a sufficient number of times so that all or at least more of the stents carried by the delivery catheter are delivered to and deployed within the body lumen. A particular advantage of this delivery method is that the discrete stents may be distributed along extended lengths of the body lumen, typically in the range from 1 cm to 2 cm, often in the range from 1 cm to 5 cm, and in many instances even longer. Additionally, the stents may be delivered so as to avoid side branches or other regions where placement of the stent is undesirable. Moreover, with the use of drug-coated stents, it may be possible to place the stents apart by discrete distances, typically from one-half to one millimeter (mm), while still achieving vessel patency and hyperplasia inhibition.
Releasing of the stents from the catheter may be achieved using a balloon to cause balloon expansion of the stent. Alternatively, release of the stent may be achieved by radially constraining an elastic or self-expanding stent within a lumen of the delivery catheter and selectively advancing the stent from the catheter and/or retracting the catheter from over the stent. In one embodiment, a sheath over the stents includes a valve member, or “stent valve,” which allows stents to be separated so that a balloon can more accurately inflate deployed stents while other stents remain within the sheath.
In preferred embodiments, the stents are coated with at least one agent, such as an agent which inhibits hyperplasia. The agent may be biologically active or inert. Particular biologically active agents include anti-neoplastic drugs such as paclitaxel, methotrexate, and batimastal; antibiotics such as doxycycline, tetracycline, rapamycin, and actinomycin; immunosuppressant such as dexamethosone, methyl prednisolone, nitric oxide sources such as nitroprussides; estrogen; estradiols; and the like. Biologically inert agents include polyethylene glycol (PEG), collagen, polyglycolic acids (PGA), ceramic material, titanium, gold and the like.
In another aspect, the present invention comprises catheters and apparatus for stenting extended lengths of a body lumen, particularly a blood vessel. The catheters comprise a catheter body having a proximal end and a distal end. At least two discrete stents are carried at or near a distal end of the catheter body. By “discrete,” it is meant that the stents are unconnected and can be deployed from the catheter in an unattached manner. (The delivery of attached prostheses is described below.) Deployment of such discrete stents permits the individual stents to be placed at spaced-apart target locations or immediately adjacently within the blood vessel or other body lumen. The catheters further comprise deployment means for deploying the individual stents from the catheter body. For example, the deployment means may comprise one or more balloons for placement and radial expansion of the stents. Alternatively, the deployment means may comprise a pusher or other device for advancing self-expanding stents from the distal end of the catheter body and/or a sheath for selectively retracting over the stents to permit self-expansion. In exemplary embodiments, the catheters will carry at least two discrete stents, at least five discrete stents, and as many as 10 discrete stents, or in some cases, as many as 30 or more discrete stents.
In a particular embodiment, the catheter comprises a single balloon which is reciprocatively mounted within the catheter body and adapted for receiving individual stents thereover. A pusher or other device for successively and controllably loading individual or multiple stents over the balloon is also provided. In this way, the catheter may carry multiple stents and employ the single balloon for positioning and expansion of the stents.
In further embodiments, the stents of the present invention are composed at least partly of a bioabsorbable material, such as polyethylene glycol (PEG), collagen, gelatin, polyglycolic acids (PGA), polylactic acids (PLA), and the like. Optionally, one or more bioactive substances are dispersed in the bioabsorbable material such that the bioactive substance will be released over time as the bioabsorbable material degrades. In a particular embodiment, the bioabsorbable material is formed on or within a scaffold composed on a non-bioabsorbable material, typically stainless steel, Nitinol™, or other conventional stent metal material. Other materials, such as gold (e.g., pure or nearly pure gold), platinum, or the like, may also be used.
In a further aspect of the present invention, a catheter for delivering a plurality of expansible prostheses to a body lumen comprises a catheter body, a sheath, and a plurality of radially expansible prostheses. The catheter body has a proximal end and a distal end, and the sheath is coaxially disposed over the catheter body with the prostheses positionable in an annular space between the inside of the sheath and the exterior of the catheter body. The sheath is preferably retractable relative to the catheter body so that the prostheses may be advanced beyond a distal end of the sheath. Usually, the catheter will further comprise a pusher tube disposed coaxially over the catheter body and within an interior lumen of the sheath. A distal end of the pusher tube will engage a proximal end of the proximal-most prosthesis so that the pusher tube can be distally advanced relative to the sheath to selectively push or deploy individual prostheses from the sheath. Often, such deployment is achieved by holding the pusher tube and prostheses substantially stationary relative to the body lumen while the sheath is retracted proximally to release or deploy the prostheses.
Usually, at least a distal portion of the sheath will have a greater column strength than that of a distal portion of the catheter body. Additionally or alternatively, the pusher tube may also have a greater column strength than a distal portion of a catheter body. By providing column strength in the outer most portion of the catheter, i.e., the sheath, and optionally the pusher tube, the overall column strength of the catheter can be increased with a minimum increase in its diameter or profile. It will be appreciated that low profile catheters are highly advantageous for accessing remote regions of the vasculature, particularly the small coronary and cerebral arteries. Using the preferred constructions of the present invention, catheters having diameters 2 mm or less, and in some instances as low as 1 mm or less, can be achieved. The constructions will, of course, also be suitable for larger diameter catheters for use in the peripheral and other larger blood vessels.
The catheter of the present invention will preferably carry at least two prostheses, more preferably carrying at least three prostheses, and often carrying a greater number of prostheses as set forth above in connection with other embodiments. The prostheses will typically be arranged in an end-to-end manner either with or without a physical linkage therebetween. The physical linkage may comprise a frangible component which must be mechanically broken or alternatively may comprise a pair of coupling elements which fit together and which may be separated without any material breakage. Frangible coupling elements will usually comprise a strut, bar, spring, or similar connecting link and will optionally be scored, notched, or otherwise adapted to break along a particular line when a suitable mechanical force is applied. Exemplary separable coupling elements include male and female elements, such as a rod and tube which may be axially separated, a tab and receptacle which may be radially separated, and the like.
In a specific embodiment of the catheter, the catheter body may comprise an expansion element, such as an inflatable balloon, near its distal end. The expansion element will be positionable distal to the retractable sheath so that it can be used to regularly expand one or more of the prostheses. For example, the inflatable balloon may carry multiple prostheses on its outer surface so that sheath retraction can expose one, two, three, or more of the prostheses. The remaining prostheses will continue to be covered by the sheath. When inflating the balloon, however, only that portion of the balloon and those prostheses carried on the exposed portion of the balloon will be inflated. The remaining (proximal) portion of the balloon will continue to be constrained by the sheath so that neither the balloon nor the prostheses covered by the sheath will be expanded. In this way, any preselected number of the individual prostheses may be expanded at one time, while the remaining prostheses are protected and unexpanded, remaining available for subsequent expansion using the balloon.
Alternatively or in addition to the balloon, the catheter body may comprise a heater for selectively heating prostheses which have been advanced distally beyond the sheath. For example, the catheter body may have a lumen for delivering a heated medium, such as heated saline, intravascularly to heat and expand stents or other prostheses formed from suitable heat memory alloys (as described in more detail below). Alternatively, a separate exterior guide catheter or other tube may be used for delivering such a heated medium to effect expansion of the prostheses. As a third alternative, a powered heating element, such as a radio frequency heater, electrical resistance heater, or laser-heated element, may be provided on the catheter body for directly heating the exposed prostheses.
For the delivery of individual prostheses or stents which are joined by frangible or breakable links, as discussed above, it will often be desirable to provide a shearing mechanism on the catheter. The shearing mechanism will usually be mechanical, but could also be electrolytic, ultrasonic, or chemical. In the exemplary embodiments, the shearing mechanism comprises a first shearing element on a distal region of the catheter body and a second or mating shearing element on a distal region of the sheath. The prostheses may be advanced from the sheath while the shearing mechanism on the catheter body is distally advanced (leaving a space or opening for prosthesis deployment). After a desired number of prostheses have been deployed, the catheter body may be retracted relative to the sheath in order to close the shearing elements to sever the link(s) between the advanced prostheses and those prostheses which remain within the sheath. In other cases, the shearing mechanism could be an electrode for inducing electrolytic breakage of the link, an ultrasonic transducer for mechanically degrading a susceptible link (i.e. a link having a resonant frequency which corresponds to the ultrasonic transducer), a luminal port for releasing a chemical agent selected to chemically degrade the link, or the like.
In a further alternative embodiment, a catheter constructed in accordance with the principles of the present invention comprises a pusher tube, a plurality of radially expansible prostheses arranged end-to-end and extending distally of the distal end of the pusher tube, and a sheath disposed coaxially over the pusher tube and the prostheses. Optionally, but not necessarily, this embodiment will include a catheter body disposed coaxially within the pusher tube and prostheses. By retracting the sheath proximally relative to the pusher tube, individual ones or groups of the prostheses will be exposed and deployed. The catheter body may be used in any of the ways described previously in order to effect or control deployment of the prostheses. Optionally, the pusher tube, the sheath, or both, may have a greater column strength than the catheter body when the catheter body is employed.
The present invention further provides methods for stenting extended lengths of the body lumen, where the methods comprise introducing a catheter carrying a plurality of radially expansible prostheses to a target site within the body lumen. The prostheses are arranged end-to-end and are covered by a sheath. The prostheses are then deployed by retracting the sheath relative to the prostheses by a first preselected distance to uncover a first predetermined number of the prostheses. After retraction of the sheath, a first predetermined number of prostheses, which may be anywhere from one up to the entire number of prostheses being carried, are radially expanded at the target site within the target site of the body lumen.
Prosthesis expansion may be achieved in a variety of ways. In a first instance, the prostheses are expanded by inflating a balloon within the particular prosthesis to be expanded. For example, a single balloon may be disposed under all the prostheses, with the sheath retracted to expose only those prostheses to be deployed. When the balloon is expanded, the balloon will expand the exposed prostheses, with expansion of the prostheses which remain covered being restrained by the sheath. By further retracting the sheath, the previously undeployed prostheses may then be deployed. Optionally, the prostheses are advanced (or at least axially restrained relative to the sheath) by a pusher tube which engages a proximal end of the proximal-most prosthesis.
As an alternative to balloon expansion, the uncovered prostheses may be expanded by exposure to heat. The heat may be applied by directing a heated medium to the prostheses, directing electrical energy through the prostheses, and/or energizing a heating element positioned adjacent to the uncovered prostheses.
In preferred aspects of the methods of the present invention, the body lumen will be a blood vessel, preferably a coronary artery, a cerebral artery, or other small artery. The prostheses will preferably be coated with biologically active or inert agent, such as an agent selected to inhibit hyperplasia, more specifically being any of the particular agents set forth hereinabove.
The invention further provides prosthesis delivery catheters and systems that include valve members to enable the selective deployment of a desired number of prostheses at a treatment site while retaining other prostheses within the device for deployment at other locations. In general, these catheters and systems will include a sheath having a proximal end, a distal end, an opening at the distal end, and a passage in communication with the opening adapted to contain a plurality of prostheses. A valve member is disposed near the distal end of the sheath adapted for selectively retaining at least one prosthesis within the passage.
The valve member may function either actively or passively. In passive configurations, the valve member prevents the prosthesis from exiting the passage under a first force and allows the prosthesis to exit the passage under a second force higher than the first force. In those embodiments for delivering balloon-expandable stents, an expandable member is slidably positioned in the sheath and the prostheses are positionable on the expandable member. Typically, the expandable member is an inflatable balloon mounted to an elongated catheter shaft. A pusher is preferably slidably mounted in the sheath and is adapted to exert a force on the prostheses to advance them distally through the sheath. In preferred embodiments, the valve member will be adapted to prevent the prostheses from being advanced out of the sheath unless sufficient force is exerted on the pusher. The distal movement of the expandable member relative to the prostheses in the sheath will not itself be sufficient to advance the prostheses past the valve member unless the pusher is also pushed against the prostheses. In this way, the desired number of prostheses can be advanced out of the sheath by pushing both the expandable member and the pusher together while holding the sheath in position (or by pulling the sheath back while maintaining the expandable member and the pusher in position). The expandable member and the prostheses to be deployed can then be advanced further relative to the sheath a desired distance without causing additional prostheses to move out of the sheath.
It should be understood that the movements of the sheath, expandable member, pusher tube and prostheses are relative and in most embodiments of the invention, either retracting the sheath proximally relative to the expandable member and pusher tube, or advancing the expandable member and pusher tube distally relative to the sheath, or a combination thereof, may be practiced without departing from the principles of the invention. Therefore, when the movement of one component relative to another component is described herein, it should be interpreted to mean holding one component in position while moving the other, or vice versa, or moving both components relative to each other.
The invention includes various exemplary embodiments of passive valve members. The valve member may comprise one or more pairs of lobes on opposing sides of the passage in the sheath and extending inwardly to engage the prostheses therein. Alternatively, one or more annular or helical ribs may be disposed on the inner wall of the sheath with an inner diameter suitable for engaging the prostheses in the passage. The invention further provides tubular valve elements, both straight and tapered, as well as valve members having a plurality of inwardly-extending projections such as bristles and flexible shafts. In alternative embodiments, the valve member may comprise a diaphragm, duckbill, or other deflectable structure, or may be a magnetic or suction-based mechanism. Multistage valves including pluralities and combinations of these elements axially spaced along the sheath are also provided.
In active embodiments, the valve member is selectively movable between a contracted configuration in which the valve member allows movement of prostheses out of the sheath, and an extended configuration in which the valve member inhibits movement of prostheses out of the sheath. In these embodiments, the valve member may comprise an inflatable member that can be selectively inflated and deflated, a movable pawl that can be extended into and retracted from the passage in the sheath, a hydraulic piston, or a heat-activated shape memory alloy wire that changes shape in response to temperature change. Further, an active valve member may comprise an enlarged portion of the sheath that has a larger outer diameter than the remainder of the sheath, wherein a tubular member is slidably disposed over the sheath and can be moved over the enlarged portion to urge the sheath into engagement with the prostheses.
The active valve member may alternatively comprise a switch having two engagement elements each movable between retracted and extended positions. The first engagement element is axially spaced apart from the second engagement element by a distance of at least about the length of one of the prostheses. The switch has two states: In one state, the first engagement element is in a retracted position and the second engagement element is in an extended position. In the second state, the first engagement element is in an extended position and the second engagement element is in a retracted position. Usually, the first engagement element is near the distal end of the sheath and the second engagement element is spaced proximally about the length of one prosthesis from the first engagement element. In this way, with the first engagement element retracted, the distal-most prosthesis can be deployed from the sheath while the second engagement element retains the remaining prostheses in the sheath. The switch can then be moved to its second state, wherein the second engagement element allows the prostheses to advance to the distal end of the sheath while the first engagement element prevents them from being deployed beyond the distal end.
In a further embodiment, the delivery catheters and systems of the invention include shuttle members for advancing selected numbers of prostheses a selected distance relative to the sheath. The shuttle member may comprise a tubular member slidably mounted over the sheath, the tubular member having an engagement element near its distal end extending inwardly to engage at least one prosthesis distally of the sheath. The shuttle member may alternatively comprise a pusher element slidably disposed within the sheath, the pusher element being configured to engage at least one of the prostheses. In one embodiment, the pusher element has an inner member slidably mounted to an outer member disposed in the sheath proximal to the plurality of prostheses. Preferably, the outer member is movable a preselected limited distance relative to the inner member, usually at least about the length of one of the prostheses. In another embodiment, the pusher element is disposed laterally of the prostheses and has a plurality of engagement elements that extend inwardly into the passage to engage the prostheses. The engagement elements are preferably axially spaced apart a distance of at least about the length of one of the prostheses. The pusher member is movable proximally relative to a selected number of prostheses in the sheath, and the pusher member is movable distally to advance the selected number of prostheses relative to the sheath. In this embodiment, the sheath will usually include engagement structures for maintaining the position of the prostheses as the pusher member moves proximally. The pusher member is configured to advance the selected number of prostheses distally of the valve member in the sheath.
The catheters of the present invention will comprise a number of coaxial components, such as sheaths, pusher tubes, catheter bodies, and the like. While it will often be described that stents or other prostheses are advanced distally from the sheath, such description will apply to sheaths which are retracted proximally relative to the prostheses to effect the release. Thus, all descriptions of direction are meant to be relative.
Referring now to
Catheter 10 will include a handle 18 at its proximal end 14. The handle may include a guidewire port 20 and a balloon inflation port 22, as well as a handle grip 24 which advances a pusher shaft whose distal end 26 is shown in
A plurality of stents 30 are carried in a lumen of the catheter body 12, as shown in
Referring now to
The balloon is then deflated, and retracted back into the distal end of the catheter 16, as illustrated in
Referring now to
Referring now to
As shown in
In
Referring now to
Axially separable coupling elements may also be provided, as illustrated in
A third approach for detachably coupling adjacent prostheses 80 is illustrated in
Referring now to
Catheter 100 of
Catheter 120 comprises a sheath 126, a pusher tube 128, and a catheter body 130 having a shearing element 132 at its distal end. Conveniently, the pusher tube 128 is coaxially received over a shaft 134 of the catheter body 130. In this way, the pusher tube may be used to axially advance each prosthesis 122 by pushing on the proximal end of the proximal-most prosthesis, as shown in
The catheter 120 is advanced over a guidewire GW to a desired target site in a blood vessel BV. After reaching the target site, at least a first prosthesis 122 is advanced from the distal end of the sheath so that it radially expands to engage an inner wall of the blood vessel. After the at least one prosthesis 122 is advanced sufficiently far, the frangible coupling elements 124 will reach a shearing element 136, typically a metal ring, disposed at the distal end of the sheath 126. By then axially retracting the catheter body 130, a chamfered surface 138 of the shearing element 132 is engaged against the shearing element 136 in order to shear the links 122, releasing the prosthesis 122, as illustrated in
Referring now to
The catheter 140 includes a sheath 144 and a pusher tube 146. The catheter 140 is advanced to a desired target site within the blood vessel BV over a guidewire GW in a conventional manner. After the distal-most prostheses 142 has been fully advanced from the sheath 144 (usually by retracting the sheath 144 while the prostheses are held stationary relative to the blood vessel BV using the pusher tube 146), as shown in
After the uncovered prostheses is properly positioned, a heated medium may be introduced through a lumen of the catheter body 148 so that it flows outwardly through the interior of the distal-most prosthesis 142. By properly selecting the temperature of the heated medium, the prosthesis to be deployed can be heated sufficiently to induce radial expansion, as illustrated in
As illustrated in
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
An alternative to the embodiment of
It should be understood that in either of the foregoing embodiments illustrated in
The embodiment of valve 185 shown in
Referring now to
In a preferred embodiment, projections 238 are configured to extend through spaces in the walls or along the edges of prostheses 182 to keep the prostheses spaced apart and rotationally oriented about the longitudinal axis of sheath 184. In an exemplary embodiment, as shown in
Referring now to
In a further embodiment, valve member 185 comprises, as shown in
Turning to
In
An alternative embodiment of an active valve member 185 is illustrated in
Referring to
In the embodiment of
A further embodiment of catheter 10 according to the invention is illustrated in
In an alternative method of using the embodiment of
In use, balloon 190 is positioned so that its distal end is within garage member 386. Inner tube 392 and outer tube 394 are both pushed distally relative to sheath 184 to advance prostheses 182 until the distal-most prosthesis 182′ engages valve member 185 at the distal end of sheath 184. Outer tube 394 is then pushed distally relative to inner tube 392 and sheath 184, pushing the distal-most prosthesis 182′ over balloon 190 into garage member 386. The engagement of pins 400 with the distal ends of slots 398 ensures that only one prosthesis 182′ is advanced past valve member 185. Balloon 190 along with prosthesis 182′ can then be moved distally out of chamber 388. If additional prostheses are to be deployed with prosthesis 182′, both parts of pusher tube 186 can be used to push prostheses 182 up to valve member 185, and the process then repeated to advance an additional prosthesis 182 into garage member 386 and onto balloon 190 behind prosthesis 182′.
In a further embodiment of catheter 10, shown in
The preferred embodiments of the invention are described above in detail for the purpose of setting forth a complete disclosure and for the sake of explanation and clarity. Those skilled in the art will envision other modifications within the scope and sprit of the present disclosure. For example, while the invention has been described as being useful for the deployment of balloon-expandable prostheses, it should be understood that the principles of the invention are equally applicable to other types of prostheses including self-expanding stents made of Nitinol or other resilient or shape memory materials. Further, the invention will find use not only for deployment of prostheses in the coronary arteries, but in other anatomical locations as well, including the carotid, femoral, and iliac arteries, and other arterial and venous locations. Therefore, the above description should not be taken to limit the scope of the invention, which is defined by the appended claims.
The present application is a continuation of U.S. patent application Ser. No. 11/538,904 filed Oct. 5, 2006, which is a divisional of U.S. patent application Ser. No. 10/412,714 filed Apr. 10, 2003, (now U.S. Pat. No. 7,137,993), which is a continuation-in-part of application Ser. No. 10/306,813, filed Nov. 27, 2002, which is a non-provisional of U.S. Patent Application Ser. Nos. 60/336,967 filed Dec. 3, 2001, and is also a non-provisional of U.S. Patent Application Ser. No. 60/364,389 filed on Mar. 13, 2002, the full disclosures of which are incorporated herein by reference.
| Number | Name | Date | Kind |
|---|---|---|---|
| 4069825 | Akiyama | Jan 1978 | A |
| 4468224 | Enzmann et al. | Aug 1984 | A |
| 4512338 | Balko | Apr 1985 | A |
| 4564014 | Fogarty et al. | Jan 1986 | A |
| 4580568 | Gianturco | Apr 1986 | A |
| 4681110 | Wiktor | Jul 1987 | A |
| 4690684 | McGreevy et al. | Sep 1987 | A |
| 4733665 | Palmaz | Mar 1988 | A |
| 4739762 | Palmaz | Apr 1988 | A |
| 4748982 | Horzewski et al. | Jun 1988 | A |
| 4762129 | Bonzel | Aug 1988 | A |
| 4770176 | McGreevy et al. | Sep 1988 | A |
| 4775337 | Van Wagener et al. | Oct 1988 | A |
| 4776337 | Palmaz | Oct 1988 | A |
| 4886062 | Wiktor | Dec 1989 | A |
| 4891225 | Langer et al. | Jan 1990 | A |
| 4950227 | Savin et al. | Aug 1990 | A |
| 4988356 | Crittenden et al. | Jan 1991 | A |
| 4994066 | Voss | Feb 1991 | A |
| 4994069 | Ritchart et al. | Feb 1991 | A |
| 4994298 | Yasuda | Feb 1991 | A |
| 5013318 | Spranza, III | May 1991 | A |
| 5035706 | Giantureo et al. | Jul 1991 | A |
| 5040548 | Yock | Aug 1991 | A |
| 5061273 | Yock | Oct 1991 | A |
| 5064435 | Porter | Nov 1991 | A |
| 5092877 | Pinchuk | Mar 1992 | A |
| 5102417 | Palmaz | Apr 1992 | A |
| 5104404 | Wolff | Apr 1992 | A |
| 5122154 | Rhodes | Jun 1992 | A |
| 5135535 | Kramer | Aug 1992 | A |
| 5158548 | Lau et al. | Oct 1992 | A |
| 5192297 | Hull | Mar 1993 | A |
| 5195984 | Schatz | Mar 1993 | A |
| 5201757 | Heyn et al. | Apr 1993 | A |
| 5217495 | Kaplan et al. | Jun 1993 | A |
| 5219355 | Parodi et al. | Jun 1993 | A |
| 5226913 | Pinchuk | Jul 1993 | A |
| 5246421 | Saab | Sep 1993 | A |
| 5261887 | Walker | Nov 1993 | A |
| 5273536 | Savas | Dec 1993 | A |
| 5282823 | Schwartz et al. | Feb 1994 | A |
| 5282824 | Gianturco | Feb 1994 | A |
| 5300085 | Yock | Apr 1994 | A |
| 5312415 | Palermo | May 1994 | A |
| 5328469 | Coletti | Jul 1994 | A |
| 5334187 | Fischell et al. | Aug 1994 | A |
| 5391172 | Williams et al. | Feb 1995 | A |
| 5421955 | Lau et al. | Jun 1995 | A |
| 5443498 | Fontaine | Aug 1995 | A |
| 5445646 | Euteneuer et al. | Aug 1995 | A |
| 5456713 | Chuter | Oct 1995 | A |
| 5458615 | Klemm et al. | Oct 1995 | A |
| 5470315 | Adams | Nov 1995 | A |
| 5478349 | Nicholas | Dec 1995 | A |
| 5484444 | Braunschweiler et al. | Jan 1996 | A |
| 5490837 | Blaeser et al. | Feb 1996 | A |
| 5496346 | Horzewski et al. | Mar 1996 | A |
| 5501227 | Yock | Mar 1996 | A |
| 5507768 | Lau et al. | Apr 1996 | A |
| 5507771 | Gianturco | Apr 1996 | A |
| 5514093 | Ellis et al. | May 1996 | A |
| 5514154 | Lau et al. | May 1996 | A |
| 5522882 | Gaterud et al. | Jun 1996 | A |
| 5527354 | Fontaine et al. | Jun 1996 | A |
| 5531735 | Thompson | Jul 1996 | A |
| 5533968 | Muni et al. | Jul 1996 | A |
| 5534007 | St. Germain et al. | Jul 1996 | A |
| 5545209 | Roberts et al. | Aug 1996 | A |
| 5549551 | Peacock, III et al. | Aug 1996 | A |
| 5549563 | Kronner | Aug 1996 | A |
| 5549635 | Solar | Aug 1996 | A |
| 5554181 | Das | Sep 1996 | A |
| 5562725 | Schmitt et al. | Oct 1996 | A |
| 5571086 | Kaplan et al. | Nov 1996 | A |
| 5591195 | Taheri et al. | Jan 1997 | A |
| 5593412 | Martinez et al. | Jan 1997 | A |
| 5607444 | Lam | Mar 1997 | A |
| 5607463 | Schwartz et al. | Mar 1997 | A |
| 5628755 | Heller et al. | May 1997 | A |
| 5628775 | Jackson et al. | May 1997 | A |
| 5634928 | Fischell et al. | Jun 1997 | A |
| 5639274 | Fischell et al. | Jun 1997 | A |
| 5662675 | Polanskyj Stockert et al. | Sep 1997 | A |
| 5662703 | Yurek et al. | Sep 1997 | A |
| 5670161 | Healy et al. | Sep 1997 | A |
| 5676654 | Ellis et al. | Oct 1997 | A |
| 5683451 | Lenker et al. | Nov 1997 | A |
| 5690644 | Yurek et al. | Nov 1997 | A |
| 5693085 | Buirge et al. | Dec 1997 | A |
| 5697948 | Marin et al. | Dec 1997 | A |
| 5697971 | Fischell et al. | Dec 1997 | A |
| 5702418 | Ravenscroft | Dec 1997 | A |
| 5702419 | Berry et al. | Dec 1997 | A |
| 5709701 | Parodi | Jan 1998 | A |
| 5716393 | Lindenberg et al. | Feb 1998 | A |
| 5722669 | Shimizu et al. | Mar 1998 | A |
| 5723003 | Winston et al. | Mar 1998 | A |
| 5735869 | Fernandez-Aceytuno | Apr 1998 | A |
| 5741323 | Pathak et al. | Apr 1998 | A |
| 5749848 | Jang et al. | May 1998 | A |
| 5749890 | Shaknovich | May 1998 | A |
| 5749921 | Lenker et al. | May 1998 | A |
| 5755697 | Jones et al. | May 1998 | A |
| 5755772 | Evans et al. | May 1998 | A |
| 5755776 | Al-Saadon | May 1998 | A |
| 5755781 | Jayaraman | May 1998 | A |
| 5769882 | Fogarty et al. | Jun 1998 | A |
| 5772669 | Vrba | Jun 1998 | A |
| 5776141 | Klein et al. | Jul 1998 | A |
| 5792144 | Fischell et al. | Aug 1998 | A |
| 5797951 | Mueller et al. | Aug 1998 | A |
| 5800519 | Sandock | Sep 1998 | A |
| 5807398 | Shaknovich | Sep 1998 | A |
| 5824040 | Cox et al. | Oct 1998 | A |
| 5824041 | Lenker et al. | Oct 1998 | A |
| 5833694 | Poncet | Nov 1998 | A |
| 5836964 | Richter et al. | Nov 1998 | A |
| 5843092 | Heller et al. | Dec 1998 | A |
| 5855563 | Kaplan et al. | Jan 1999 | A |
| 5858556 | Eckert et al. | Jan 1999 | A |
| 5870381 | Kawasaki et al. | Feb 1999 | A |
| 5879370 | Fischell et al. | Mar 1999 | A |
| 5891190 | Boneau | Apr 1999 | A |
| 5895398 | Wensel et al. | Apr 1999 | A |
| 5899935 | Ding | May 1999 | A |
| 5902332 | Schatz | May 1999 | A |
| 5919175 | Sirhan | Jul 1999 | A |
| 5921971 | Agro et al. | Jul 1999 | A |
| 5922020 | Klein et al. | Jul 1999 | A |
| 5941869 | Patterson et al. | Aug 1999 | A |
| 5951585 | Cathcart et al. | Sep 1999 | A |
| 5961536 | Mickley et al. | Oct 1999 | A |
| 5968069 | Dusbabek et al. | Oct 1999 | A |
| 5972027 | Johnson | Oct 1999 | A |
| 5976107 | Mertens et al. | Nov 1999 | A |
| 5976155 | Foreman et al. | Nov 1999 | A |
| 5980484 | Ressemann et al. | Nov 1999 | A |
| 5980486 | Enger | Nov 1999 | A |
| 5980514 | Kupiecki et al. | Nov 1999 | A |
| 5980552 | Pinchasik et al. | Nov 1999 | A |
| 5984957 | Laptewicz, Jr. et al. | Nov 1999 | A |
| 5989280 | Euteneuer et al. | Nov 1999 | A |
| 5993484 | Shmulewitz | Nov 1999 | A |
| 5997563 | Kretzers | Dec 1999 | A |
| 6004328 | Solar | Dec 1999 | A |
| 6007517 | Anderson | Dec 1999 | A |
| 6010530 | Goicoechea | Jan 2000 | A |
| 6022359 | Frantzen | Feb 2000 | A |
| 6022374 | Imran | Feb 2000 | A |
| 6027519 | Stanford | Feb 2000 | A |
| 6033434 | Borghi | Mar 2000 | A |
| 6036725 | Avellanet | Mar 2000 | A |
| 6039721 | Johnson et al. | Mar 2000 | A |
| 6042589 | Marianne | Mar 2000 | A |
| 6050999 | Paraschac et al. | Apr 2000 | A |
| 6056722 | Jayaraman | May 2000 | A |
| 6063111 | Hieshima et al. | May 2000 | A |
| 6066155 | Amann et al. | May 2000 | A |
| 6068655 | Seguin et al. | May 2000 | A |
| 6070589 | Keith et al. | Jun 2000 | A |
| 6090063 | Makower et al. | Jul 2000 | A |
| 6090136 | McDonald et al. | Jul 2000 | A |
| 6102942 | Ahari | Aug 2000 | A |
| 6106530 | Harada | Aug 2000 | A |
| RE36857 | Euteneuer et al. | Sep 2000 | E |
| 6120522 | Vrba et al. | Sep 2000 | A |
| 6123712 | Di Caprio et al. | Sep 2000 | A |
| 6123723 | Konya et al. | Sep 2000 | A |
| 6126685 | Lenker et al. | Oct 2000 | A |
| 6129756 | Kugler | Oct 2000 | A |
| 6132460 | Thompson | Oct 2000 | A |
| 6139572 | Campbell et al. | Oct 2000 | A |
| 6143016 | Bleam et al. | Nov 2000 | A |
| 6165167 | Delaloye | Dec 2000 | A |
| 6165210 | Lau et al. | Dec 2000 | A |
| 6171334 | Cox | Jan 2001 | B1 |
| 6179878 | Duering | Jan 2001 | B1 |
| 6183509 | Dibie | Feb 2001 | B1 |
| 6187034 | Frantzen | Feb 2001 | B1 |
| 6190402 | Horton et al. | Feb 2001 | B1 |
| 6196995 | Fagan | Mar 2001 | B1 |
| 6200337 | Moriuchi et al. | Mar 2001 | B1 |
| 6217585 | Houser et al. | Apr 2001 | B1 |
| 6238991 | Suzuki | May 2001 | B1 |
| 6241691 | Ferrera et al. | Jun 2001 | B1 |
| 6241758 | Cox | Jun 2001 | B1 |
| 6248122 | Klumb et al. | Jun 2001 | B1 |
| 6251132 | Ravenscroft et al. | Jun 2001 | B1 |
| 6251134 | Alt et al. | Jun 2001 | B1 |
| 6254612 | Hieshima | Jul 2001 | B1 |
| 6254628 | Wallace et al. | Jul 2001 | B1 |
| 6258117 | Camrud et al. | Jul 2001 | B1 |
| 6264688 | Herklotz et al. | Jul 2001 | B1 |
| 6267783 | Letendre et al. | Jul 2001 | B1 |
| 6270524 | Kim | Aug 2001 | B1 |
| 6273895 | Pinchuk et al. | Aug 2001 | B1 |
| 6273911 | Cox et al. | Aug 2001 | B1 |
| 6273913 | Wright et al. | Aug 2001 | B1 |
| 6287291 | Bigus et al. | Sep 2001 | B1 |
| 6312458 | Golds | Nov 2001 | B1 |
| 6315794 | Richter | Nov 2001 | B1 |
| 6319277 | Rudnick et al. | Nov 2001 | B1 |
| 6322586 | Monroe et al. | Nov 2001 | B1 |
| 6325823 | Horzewski et al. | Dec 2001 | B1 |
| 6334871 | Dor et al. | Jan 2002 | B1 |
| 6340366 | Wijay | Jan 2002 | B2 |
| 6344272 | Oldenburg et al. | Feb 2002 | B1 |
| 6348065 | Brown et al. | Feb 2002 | B1 |
| 6350252 | Ray et al. | Feb 2002 | B2 |
| 6350277 | Kocur | Feb 2002 | B1 |
| 6357104 | Myers | Mar 2002 | B1 |
| 6361558 | Hieshima et al. | Mar 2002 | B1 |
| 6375676 | Cox | Apr 2002 | B1 |
| 6379365 | Diaz | Apr 2002 | B1 |
| 6383171 | Gifford et al. | May 2002 | B1 |
| 6394995 | Solar et al. | May 2002 | B1 |
| 6409753 | Brown et al. | Jun 2002 | B1 |
| 6415696 | Erickeson et al. | Jul 2002 | B1 |
| 6416543 | Hilaire et al. | Jul 2002 | B1 |
| 6419693 | Fariabi | Jul 2002 | B1 |
| 6425898 | Wilson et al. | Jul 2002 | B1 |
| 6428811 | West et al. | Aug 2002 | B1 |
| 6451025 | Jervis | Sep 2002 | B1 |
| 6451050 | Rudakov et al. | Sep 2002 | B1 |
| 6464720 | Boatman et al. | Oct 2002 | B2 |
| 6468298 | Pelton | Oct 2002 | B1 |
| 6468299 | Stack et al. | Oct 2002 | B2 |
| 6485510 | Camrud et al. | Nov 2002 | B1 |
| 6488694 | Lau et al. | Dec 2002 | B1 |
| 6488702 | Besselink | Dec 2002 | B1 |
| 6511468 | Cragg et al. | Jan 2003 | B1 |
| 6520986 | Martin et al. | Feb 2003 | B2 |
| 6520987 | Plante | Feb 2003 | B1 |
| 6527789 | Lau et al. | Mar 2003 | B1 |
| 6527799 | Shanley | Mar 2003 | B2 |
| 6530944 | West et al. | Mar 2003 | B2 |
| 6540777 | Stenzel | Apr 2003 | B2 |
| 6551350 | Thornton et al. | Apr 2003 | B1 |
| 6555157 | Hossainy | Apr 2003 | B1 |
| 6558415 | Thompson | May 2003 | B2 |
| 6562067 | Mathis | May 2003 | B2 |
| 6565599 | Hong et al. | May 2003 | B1 |
| 6569180 | Sirhan et al. | May 2003 | B1 |
| 6575993 | Yock | Jun 2003 | B1 |
| 6579305 | Lashinski | Jun 2003 | B1 |
| 6579309 | Loos et al. | Jun 2003 | B1 |
| 6582394 | Reiss et al. | Jun 2003 | B1 |
| 6582460 | Cryer | Jun 2003 | B1 |
| 6585756 | Strecker | Jul 2003 | B1 |
| 6589273 | McDermott | Jul 2003 | B1 |
| 6592549 | Gerdts et al. | Jul 2003 | B2 |
| 6599296 | Gillick et al. | Jul 2003 | B1 |
| 6599314 | Mathis | Jul 2003 | B2 |
| 6602226 | Smith et al. | Aug 2003 | B1 |
| 6602282 | Yan | Aug 2003 | B1 |
| 6605062 | Hurley et al. | Aug 2003 | B1 |
| 6605109 | Fiedler | Aug 2003 | B2 |
| 6607553 | Healy et al. | Aug 2003 | B1 |
| 6613074 | Mitelberg et al. | Sep 2003 | B1 |
| 6629992 | Bigus et al. | Oct 2003 | B2 |
| 6645517 | West | Nov 2003 | B2 |
| 6645547 | Shekalim et al. | Nov 2003 | B1 |
| 6656212 | Ravenscroft et al. | Dec 2003 | B2 |
| 6660031 | Tran et al. | Dec 2003 | B2 |
| 6660381 | Halas et al. | Dec 2003 | B2 |
| 6663660 | Dusbabek et al. | Dec 2003 | B2 |
| 6666883 | Seguin et al. | Dec 2003 | B1 |
| 6676693 | Belding et al. | Jan 2004 | B1 |
| 6676695 | Solem | Jan 2004 | B2 |
| 6679909 | McIntosh et al. | Jan 2004 | B2 |
| 6685730 | West et al. | Feb 2004 | B2 |
| 6692465 | Kramer | Feb 2004 | B2 |
| 6699280 | Camrud et al. | Mar 2004 | B2 |
| 6699281 | Vallana et al. | Mar 2004 | B2 |
| 6699724 | West et al. | Mar 2004 | B1 |
| 6702843 | Brown | Mar 2004 | B1 |
| 6709379 | Brandau et al. | Mar 2004 | B1 |
| 6709440 | Callol et al. | Mar 2004 | B2 |
| 6712827 | Ellis et al. | Mar 2004 | B2 |
| 6712845 | Hossainy | Mar 2004 | B2 |
| 6723071 | Gerdts et al. | Apr 2004 | B2 |
| 6736842 | Healy et al. | May 2004 | B2 |
| 6743219 | Dwyer et al. | Jun 2004 | B1 |
| 6743251 | Eder | Jun 2004 | B1 |
| 6761734 | Suhr | Jul 2004 | B2 |
| 6776771 | van Moorlegem et al. | Aug 2004 | B2 |
| 6778316 | Halas et al. | Aug 2004 | B2 |
| 6790227 | Burgermeister | Sep 2004 | B2 |
| 6800065 | Duane et al. | Oct 2004 | B2 |
| 6825203 | Pasternak et al. | Nov 2004 | B2 |
| 6837901 | Rabkin et al. | Jan 2005 | B2 |
| 6849084 | Rabkin et al. | Feb 2005 | B2 |
| 6852252 | Halas et al. | Feb 2005 | B2 |
| 6855125 | Shanley | Feb 2005 | B2 |
| 6858034 | Hijlkema et al. | Feb 2005 | B1 |
| 6878161 | Lenker | Apr 2005 | B2 |
| 6884257 | Cox | Apr 2005 | B1 |
| 6893417 | Gribbons et al. | May 2005 | B2 |
| 6896695 | Mueller et al. | May 2005 | B2 |
| 6899728 | Phillips et al. | May 2005 | B1 |
| 6913619 | Brown et al. | Jul 2005 | B2 |
| 6918928 | Wolinsky et al. | Jul 2005 | B2 |
| 6939376 | Shulz et al. | Sep 2005 | B2 |
| 6945989 | Betelia et al. | Sep 2005 | B1 |
| 6945995 | Nicholas | Sep 2005 | B2 |
| 6951053 | Padilla et al. | Oct 2005 | B2 |
| 6962603 | Brown et al. | Nov 2005 | B1 |
| 6964676 | Gerberding et al. | Nov 2005 | B1 |
| 6991646 | Clerc et al. | Jan 2006 | B2 |
| 6994721 | Israel | Feb 2006 | B2 |
| 7005454 | Brocchini et al. | Feb 2006 | B2 |
| 7022132 | Kocur | Apr 2006 | B2 |
| 7029493 | Majercak et al. | Apr 2006 | B2 |
| 7037327 | Salmon et al. | May 2006 | B2 |
| 7090694 | Morris et al. | Aug 2006 | B1 |
| 7101840 | Brocchini et al. | Sep 2006 | B2 |
| 7131993 | Gregorich | Nov 2006 | B2 |
| 7137993 | Acosta et al. | Nov 2006 | B2 |
| 7141063 | White et al. | Nov 2006 | B2 |
| 7147655 | Chermoni | Dec 2006 | B2 |
| 7147656 | Andreas et al. | Dec 2006 | B2 |
| 7169172 | Levine et al. | Jan 2007 | B2 |
| 7169174 | Fischell et al. | Jan 2007 | B2 |
| 7172620 | Gilson | Feb 2007 | B2 |
| 7175654 | Bonsignore et al. | Feb 2007 | B2 |
| 7182779 | Acosta et al. | Feb 2007 | B2 |
| 7192440 | Andreas et al. | Mar 2007 | B2 |
| 7208001 | Coyle et al. | Apr 2007 | B2 |
| 7208002 | Shelso | Apr 2007 | B2 |
| 7220275 | Davidson et al. | May 2007 | B2 |
| 7220755 | Betts et al. | May 2007 | B2 |
| 7223283 | Chouinard | May 2007 | B2 |
| 7238197 | Sequin et al. | Jul 2007 | B2 |
| 7241308 | Andreas et al. | Jul 2007 | B2 |
| 7244336 | Fischer et al. | Jul 2007 | B2 |
| 7270668 | Andreas et al. | Sep 2007 | B2 |
| 7294146 | Chew et al. | Nov 2007 | B2 |
| 7300456 | Andreas et al. | Nov 2007 | B2 |
| 7309350 | Landreville et al. | Dec 2007 | B2 |
| 7314480 | Eidenschink et al. | Jan 2008 | B2 |
| 7320702 | Hammersmark et al. | Jan 2008 | B2 |
| 7323006 | Andreas et al. | Jan 2008 | B2 |
| 7326236 | Andreas et al. | Feb 2008 | B2 |
| 7351255 | Andreas | Apr 2008 | B2 |
| 7534449 | Saltzman et al. | May 2009 | B2 |
| 7699886 | Sugimoto | Apr 2010 | B2 |
| 7824439 | Toyokawa | Nov 2010 | B2 |
| 7918881 | Andreas et al. | Apr 2011 | B2 |
| 7993388 | Lee et al. | Aug 2011 | B2 |
| 8070794 | Issenmann | Dec 2011 | B2 |
| 8257427 | Andersen et al. | Sep 2012 | B2 |
| 8317850 | Kusleika | Nov 2012 | B2 |
| 20010001824 | Wu | May 2001 | A1 |
| 20010020154 | Bigus et al. | Sep 2001 | A1 |
| 20010020173 | Klumb et al. | Sep 2001 | A1 |
| 20010020181 | Layne | Sep 2001 | A1 |
| 20010035902 | Iddan et al. | Nov 2001 | A1 |
| 20010044595 | Reydel et al. | Nov 2001 | A1 |
| 20010044632 | Daniel et al. | Nov 2001 | A1 |
| 20010049547 | Moore | Dec 2001 | A1 |
| 20020007212 | Brown et al. | Jan 2002 | A1 |
| 20020032457 | Sirhan et al. | Mar 2002 | A1 |
| 20020037358 | Barry et al. | Mar 2002 | A1 |
| 20020045914 | Roberts et al. | Apr 2002 | A1 |
| 20020052642 | Cox et al. | May 2002 | A1 |
| 20020087186 | Shelso | Jul 2002 | A1 |
| 20020091439 | Baker et al. | Jul 2002 | A1 |
| 20020092536 | LaFontaine et al. | Jul 2002 | A1 |
| 20020107560 | Richter | Aug 2002 | A1 |
| 20020111671 | Stenzel | Aug 2002 | A1 |
| 20020123786 | Gittings et al. | Sep 2002 | A1 |
| 20020128706 | Osypka | Sep 2002 | A1 |
| 20020138132 | Brown | Sep 2002 | A1 |
| 20020151924 | Shiber | Oct 2002 | A1 |
| 20020151955 | Tran et al. | Oct 2002 | A1 |
| 20020156496 | Chermoni | Oct 2002 | A1 |
| 20020165599 | Nasralla | Nov 2002 | A1 |
| 20020168317 | Daighighian et al. | Nov 2002 | A1 |
| 20020177890 | Lenker | Nov 2002 | A1 |
| 20020183763 | Callol et al. | Dec 2002 | A1 |
| 20020188343 | Mathis | Dec 2002 | A1 |
| 20020188347 | Mathis | Dec 2002 | A1 |
| 20020193873 | Brucker et al. | Dec 2002 | A1 |
| 20030045923 | Bashiri et al. | Mar 2003 | A1 |
| 20030093143 | Zhao et al. | May 2003 | A1 |
| 20030097169 | Brucker et al. | May 2003 | A1 |
| 20030105511 | Welsh et al. | Jun 2003 | A1 |
| 20030114912 | Sequin et al. | Jun 2003 | A1 |
| 20030114919 | McQuiston et al. | Jun 2003 | A1 |
| 20030114922 | Iwasaka et al. | Jun 2003 | A1 |
| 20030125791 | Sequin et al. | Jul 2003 | A1 |
| 20030125800 | Shulze et al. | Jul 2003 | A1 |
| 20030125802 | Callol et al. | Jul 2003 | A1 |
| 20030135259 | Simso | Jul 2003 | A1 |
| 20030135266 | Chew et al. | Jul 2003 | A1 |
| 20030139796 | Sequin et al. | Jul 2003 | A1 |
| 20030139797 | Johnson et al. | Jul 2003 | A1 |
| 20030139798 | Brown et al. | Jul 2003 | A1 |
| 20030163085 | Tanner et al. | Aug 2003 | A1 |
| 20030163155 | Haverkost et al. | Aug 2003 | A1 |
| 20030176909 | Kusleika | Sep 2003 | A1 |
| 20030191516 | Weldon et al. | Oct 2003 | A1 |
| 20030195609 | Berenstein | Oct 2003 | A1 |
| 20030199821 | Gerdts et al. | Oct 2003 | A1 |
| 20030204238 | Tedeschi | Oct 2003 | A1 |
| 20030208223 | Kleiner | Nov 2003 | A1 |
| 20030212447 | Euteneuer | Nov 2003 | A1 |
| 20030225446 | Hartley | Dec 2003 | A1 |
| 20040015224 | Armstrong et al. | Jan 2004 | A1 |
| 20040024450 | Shulze et al. | Feb 2004 | A1 |
| 20040030380 | Shulze et al. | Feb 2004 | A1 |
| 20040044395 | Nelson | Mar 2004 | A1 |
| 20040073290 | Chouinard | Apr 2004 | A1 |
| 20040088044 | Brown et al. | May 2004 | A1 |
| 20040093061 | Acosta et al. | May 2004 | A1 |
| 20040093067 | Israel | May 2004 | A1 |
| 20040106979 | Goicoechea | Jun 2004 | A1 |
| 20040111145 | Serino et al. | Jun 2004 | A1 |
| 20040117008 | Wnendt et al. | Jun 2004 | A1 |
| 20040138737 | Davidson et al. | Jul 2004 | A1 |
| 20040143322 | Litvack et al. | Jul 2004 | A1 |
| 20040176832 | Hartley et al. | Sep 2004 | A1 |
| 20040181239 | Dorn et al. | Sep 2004 | A1 |
| 20040186551 | Kao et al. | Sep 2004 | A1 |
| 20040193245 | Deem et al. | Sep 2004 | A1 |
| 20040215165 | Coyle et al. | Oct 2004 | A1 |
| 20040215312 | Andreas | Oct 2004 | A1 |
| 20040215331 | Chew et al. | Oct 2004 | A1 |
| 20040230285 | Gifford, III et al. | Nov 2004 | A1 |
| 20040243217 | Andersen et al. | Dec 2004 | A1 |
| 20040249434 | Andreas et al. | Dec 2004 | A1 |
| 20040249439 | Richter et al. | Dec 2004 | A1 |
| 20050004657 | Burgermeister | Jan 2005 | A1 |
| 20050010276 | Acosta et al. | Jan 2005 | A1 |
| 20050038494 | Eidenschink | Feb 2005 | A1 |
| 20050038505 | Shulze et al. | Feb 2005 | A1 |
| 20050049673 | Andreas et al. | Mar 2005 | A1 |
| 20050055077 | Marco et al. | Mar 2005 | A1 |
| 20050075716 | Yan | Apr 2005 | A1 |
| 20050080474 | Andreas et al. | Apr 2005 | A1 |
| 20050080475 | Andreas et al. | Apr 2005 | A1 |
| 20050085897 | Bonsignore | Apr 2005 | A1 |
| 20050090846 | Pedersen et al. | Apr 2005 | A1 |
| 20050123451 | Nomura | Jun 2005 | A1 |
| 20050125051 | Eidenschink et al. | Jun 2005 | A1 |
| 20050131008 | Betts et al. | Jun 2005 | A1 |
| 20050137622 | Griffin | Jun 2005 | A1 |
| 20050143827 | Globerman et al. | Jun 2005 | A1 |
| 20050149168 | Gregorich | Jul 2005 | A1 |
| 20050165378 | Heinrich et al. | Jul 2005 | A1 |
| 20050171568 | Duffy | Aug 2005 | A1 |
| 20050182477 | White | Aug 2005 | A1 |
| 20050209674 | Kutscher et al. | Sep 2005 | A1 |
| 20050209676 | Kusleika | Sep 2005 | A1 |
| 20050209680 | Gale et al. | Sep 2005 | A1 |
| 20050222671 | Schaeffer et al. | Oct 2005 | A1 |
| 20050228477 | Grainger et al. | Oct 2005 | A1 |
| 20050245637 | Hossainy et al. | Nov 2005 | A1 |
| 20050249777 | Michal et al. | Nov 2005 | A1 |
| 20050278011 | Peckham | Dec 2005 | A1 |
| 20050288764 | Snow et al. | Dec 2005 | A1 |
| 20050288766 | Plain et al. | Dec 2005 | A1 |
| 20060069424 | Acosta et al. | Mar 2006 | A1 |
| 20060173529 | Blank | Aug 2006 | A1 |
| 20060177476 | Saffran | Aug 2006 | A1 |
| 20060200223 | Andreas et al. | Sep 2006 | A1 |
| 20060206190 | Chermoni | Sep 2006 | A1 |
| 20060229700 | Acosta et al. | Oct 2006 | A1 |
| 20060229706 | Shulze et al. | Oct 2006 | A1 |
| 20060271150 | Andreas et al. | Nov 2006 | A1 |
| 20060271151 | McGarry et al. | Nov 2006 | A1 |
| 20060282147 | Andreas et al. | Dec 2006 | A1 |
| 20060282149 | Kao | Dec 2006 | A1 |
| 20060282150 | Olson et al. | Dec 2006 | A1 |
| 20060287726 | Segal et al. | Dec 2006 | A1 |
| 20070010869 | Sano | Jan 2007 | A1 |
| 20070027521 | Andreas et al. | Feb 2007 | A1 |
| 20070043419 | Nikolchev et al. | Feb 2007 | A1 |
| 20070067012 | George et al. | Mar 2007 | A1 |
| 20070088368 | Acosta et al. | Apr 2007 | A1 |
| 20070088420 | Andreas et al. | Apr 2007 | A1 |
| 20070088422 | Chew et al. | Apr 2007 | A1 |
| 20070100423 | Acosta et al. | May 2007 | A1 |
| 20070100424 | Chew et al. | May 2007 | A1 |
| 20070106365 | Andreas et al. | May 2007 | A1 |
| 20070118202 | Chermoni | May 2007 | A1 |
| 20070118203 | Chermoni | May 2007 | A1 |
| 20070118204 | Chermoni | May 2007 | A1 |
| 20070129733 | Will et al. | Jun 2007 | A1 |
| 20070135906 | Badylak et al. | Jun 2007 | A1 |
| 20070156225 | George et al. | Jul 2007 | A1 |
| 20070156226 | Chew et al. | Jul 2007 | A1 |
| 20070179587 | Acosta et al. | Aug 2007 | A1 |
| 20070219612 | Andreas et al. | Sep 2007 | A1 |
| 20070219613 | Kao et al. | Sep 2007 | A1 |
| 20070265637 | Andreas et al. | Nov 2007 | A1 |
| 20070270936 | Andreas et al. | Nov 2007 | A1 |
| 20070276461 | Andreas et al. | Nov 2007 | A1 |
| 20070281117 | Kaplan et al. | Dec 2007 | A1 |
| 20070292518 | Ludwig | Dec 2007 | A1 |
| 20080004690 | Robaina | Jan 2008 | A1 |
| 20080046067 | Toyokawa | Feb 2008 | A1 |
| 20080071345 | Hammersmark et al. | Mar 2008 | A1 |
| 20080077229 | Andreas et al. | Mar 2008 | A1 |
| 20080091257 | Andreas et al. | Apr 2008 | A1 |
| 20080097299 | Andreas et al. | Apr 2008 | A1 |
| 20080097574 | Andreas et al. | Apr 2008 | A1 |
| 20080125850 | Andreas et al. | May 2008 | A1 |
| 20080132989 | Snow et al. | Jun 2008 | A1 |
| 20080147162 | Andreas et al. | Jun 2008 | A1 |
| 20080177369 | Will et al. | Jul 2008 | A1 |
| 20080199510 | Ruane et al. | Aug 2008 | A1 |
| 20080208311 | Kao et al. | Aug 2008 | A1 |
| 20080208318 | Kao et al. | Aug 2008 | A1 |
| 20080234795 | Snow et al. | Sep 2008 | A1 |
| 20080234798 | Chew et al. | Sep 2008 | A1 |
| 20080234799 | Acosta et al. | Sep 2008 | A1 |
| 20080243225 | Satasiya et al. | Oct 2008 | A1 |
| 20080249607 | Webster et al. | Oct 2008 | A1 |
| 20080269865 | Snow et al. | Oct 2008 | A1 |
| 20090076584 | Mao et al. | Mar 2009 | A1 |
| 20090105686 | Snow et al. | Apr 2009 | A1 |
| 20090149863 | Andreas et al. | Jun 2009 | A1 |
| 20090234428 | Snow et al. | Sep 2009 | A1 |
| 20090248137 | Andersen et al. | Oct 2009 | A1 |
| 20090248140 | Gerberding | Oct 2009 | A1 |
| 20090264979 | Kao et al. | Oct 2009 | A1 |
| 20090276030 | Kusleika | Nov 2009 | A1 |
| 20100004729 | Chew et al. | Jan 2010 | A1 |
| Number | Date | Country |
|---|---|---|
| 1 953 1659 | Mar 1997 | DE |
| 1 963 0469 | Jan 1998 | DE |
| 199 50 756 | Aug 2000 | DE |
| 101 03 000 | Aug 2002 | DE |
| 0 203 945 | Dec 1986 | EP |
| 0 274 129 | Jul 1988 | EP |
| 0 282 143 | Sep 1988 | EP |
| 0 364 787 | Apr 1990 | EP |
| 0 505 686 | Sep 1992 | EP |
| 0 533 960 | Mar 1993 | EP |
| 0 596 145 | May 1994 | EP |
| 0 696 447 | Feb 1996 | EP |
| 0 714 640 | Jun 1996 | EP |
| 0 797 963 | Oct 1997 | EP |
| 0 947 180 | Oct 1999 | EP |
| 1 254 644 | Nov 2002 | EP |
| 1 258 230 | Nov 2002 | EP |
| 1 266 638 | Dec 2002 | EP |
| 1 277 449 | Jan 2003 | EP |
| 1 290 987 | Mar 2003 | EP |
| 1 318 765 | Jun 2003 | EP |
| 1 470 834 | Oct 2004 | EP |
| 1 523 959 | Apr 2005 | EP |
| 1 523 960 | Apr 2005 | EP |
| 2277875 | Nov 1994 | GB |
| 03-133446 | Jun 1991 | JP |
| 07-132148 | May 1995 | JP |
| 10-503663 | Apr 1998 | JP |
| 10-295823 | Nov 1998 | JP |
| 11-503056 | Mar 1999 | JP |
| 2935561 | Aug 1999 | JP |
| 2001-190687 | Jul 2001 | JP |
| 2002-538932 | Nov 2002 | JP |
| 2004-121343 | Apr 2004 | JP |
| 9427667 | Dec 1994 | WO |
| 9526695 | Oct 1995 | WO |
| 9529647 | Nov 1995 | WO |
| 9626689 | Sep 1996 | WO |
| 9633677 | Oct 1996 | WO |
| 9637167 | Nov 1996 | WO |
| 9639077 | Dec 1996 | WO |
| 9710778 | Mar 1997 | WO |
| 9746174 | Dec 1997 | WO |
| 9748351 | Dec 1997 | WO |
| 9820810 | May 1998 | WO |
| 9837833 | Sep 1998 | WO |
| 9858600 | Dec 1998 | WO |
| 9901087 | Jan 1999 | WO |
| 9965421 | Dec 1999 | WO |
| 0012832 | Mar 2000 | WO |
| 0015151 | Mar 2000 | WO |
| 0025841 | May 2000 | WO |
| 0032136 | Jun 2000 | WO |
| 0041649 | Jul 2000 | WO |
| 0050116 | Aug 2000 | WO |
| 0051525 | Sep 2000 | WO |
| 0056237 | Sep 2000 | WO |
| 0062708 | Oct 2000 | WO |
| 0072780 | Dec 2000 | WO |
| 0126707 | Apr 2001 | WO |
| 0134063 | May 2001 | WO |
| 0170297 | Sep 2001 | WO |
| 0191918 | Dec 2001 | WO |
| 02071975 | Sep 2002 | WO |
| 02085253 | Oct 2002 | WO |
| 02098326 | Dec 2002 | WO |
| 03022178 | Mar 2003 | WO |
| 03047651 | Jun 2003 | WO |
| 03051425 | Jun 2003 | WO |
| 03075797 | Sep 2003 | WO |
| 2004017865 | Mar 2004 | WO |
| 2004043299 | May 2004 | WO |
| 2004043301 | May 2004 | WO |
| 2004043510 | May 2004 | WO |
| 2004052237 | Jun 2004 | WO |
| 2004087006 | Oct 2004 | WO |
| 2004091441 | Oct 2004 | WO |
| 2005009295 | Feb 2005 | WO |
| 2005013853 | Feb 2005 | WO |
| 2005023153 | Mar 2005 | WO |
| 2006036939 | Apr 2006 | WO |
| 2006047520 | May 2006 | WO |
| 2007035805 | Mar 2007 | WO |
| 2007053187 | May 2007 | WO |
| 2007146411 | Dec 2007 | WO |
| 2008005111 | Jan 2008 | WO |
| Entry |
|---|
| Supplementary European Search Report of EP Patent Application No. 05727731.1, dated Mar. 25, 2008, 2 pages total. |
| Supplementary European Search Report of EP Patent Application No. 05744136, dated Mar. 26, 2008, 3 pages total. |
| U.S. Appl. No. 60/336,607, filed Dec. 3, 2001, first named inventor: Bernard Andreas. |
| U.S. Appl. No. 60/336,767, filed Dec. 3, 2001, first named inventor: Bernard Andreas. |
| U.S. Appl. No. 60/336,967, filed Dec. 3, 2001, first named inventor: Sunmi Chew. |
| U.S. Appl. No. 60/364,389, filed Mar. 13, 2002, first named inventor: Sunmi Chew. |
| U.S. Appl. No. 60/440,839, filed Jan. 17, 2003, first named inventor: Bernard Andreas. |
| U.S. Appl. No. 60/561,041, filed Apr. 9, 2004, first named inventor: Jeffry Grainger. |
| U.S. Appl. No. 60/784,309, filed Mar. 20, 2006, first named inventor: Bernard Andreas. |
| U.S. Appl. No. 60/810,522, filed Jun. 2, 2006, first named inventor: Stephen Kaplan. |
| U.S. Appl. No. 60/890,703, filed Feb. 20, 2007, first named inventor: Patrick Ruane. |
| Supplementary European Search Report of EP Patent Application No. 07758831, dated Dec. 14, 2009. |
| Chu et al., “Preparation of Thermo-Responsive Core-Shell Microcapsules with a Porous Membrane and Poly(N-isopropylacrylamide) Gates,” J Membrane Sci, Oct. 15, 2001; 192(1-2):27-39. |
| Colombo, “The Invatec Bifurcation Stent Solution” Bifurcation Stents: Novel Solutions, TCT 2003, Washington: Sep. 15-19, 2003, 24 pages total. |
| Cooley et al., “Applications of Ink-Jet Printing Technology to BioMEMs and Microfluidic Systems,” Proceedings, SPIE Conference on Microfluidics and BioMEMs, (Oct. 2001). |
| “Drug Delivery Stent With Holes Located on Neutral Axis” Research Disclosure, Kenneth Mason Publications, Hampshire, CB, No. 429, Jan. 2000, p. 13. |
| Evans Analytical Group, “Functional Sites on Non-polymeric Materials: Gas Plasma Treatment and Surface Analysis,” http://www.eaglabs.com. |
| Joung et al., “Estrogen Release from Metallic Stent Surface for the Prevention of Restenosis,” J Control Release. Sep. 19, 2003;92(1-2):83-91. |
| Lefevre et al. “Approach to Coronary Bifurcation Stenting in 2003,” Euro PCR, (May 2003) 28 pages total. |
| “Stent”. Definitions from Dictionary.com. Unabridged 9v1.01). Retrieved Sep. 22, 2006, from Dictionary.com website: <http://dictionary.reference.com/search?q=stent>. |
| Stimpson et al., “Parallel Production of Oligonucleotide Arrays Using Membranes and Reagent Jet Printing,” BioTechniques 25:886-890 (Nov. 1998). |
| Tilley , “Biolimus A9-Eluting Stent Shows Promise,” Medscape Medical News, Oct. 5, 2004; retrieved from the internet: <http://www.medscape.com/viewarticle/490621>, 2 pages total. |
| Weir et al., “Degradation of poly-L-lactide. Part 2: increased temperature accelerated degradation,” Proc Inst Mech Eng H. 2004;218(5):321-30. |
| Number | Date | Country | |
|---|---|---|---|
| 20110152996 A1 | Jun 2011 | US |
| Number | Date | Country | |
|---|---|---|---|
| 60364389 | Mar 2002 | US | |
| 60336967 | Dec 2001 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10412714 | Apr 2003 | US |
| Child | 11538904 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11538904 | Oct 2006 | US |
| Child | 13037140 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10306813 | Nov 2002 | US |
| Child | 10412714 | US |
