WO2004112653A2 - Dispositifs et procedes pour l'apport et la formation in situ de structures d'endoprotheses individuelles et multiples - Google Patents

Dispositifs et procedes pour l'apport et la formation in situ de structures d'endoprotheses individuelles et multiples Download PDF

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Publication number
WO2004112653A2
WO2004112653A2 PCT/US2004/019517 US2004019517W WO2004112653A2 WO 2004112653 A2 WO2004112653 A2 WO 2004112653A2 US 2004019517 W US2004019517 W US 2004019517W WO 2004112653 A2 WO2004112653 A2 WO 2004112653A2
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WIPO (PCT)
Prior art keywords
stent precursor
stent
precursor
delivery structure
delivery
Prior art date
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PCT/US2004/019517
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English (en)
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WO2004112653A3 (fr
Inventor
Doron Marco
Tuvia Dror Kutscher
Original Assignee
D-Crown Ltd.
Wheelock, E., Thomas
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Priority claimed from US10/636,877 external-priority patent/US20040260380A1/en
Priority claimed from US10/636,927 external-priority patent/US20040260381A1/en
Application filed by D-Crown Ltd., Wheelock, E., Thomas filed Critical D-Crown Ltd.
Publication of WO2004112653A2 publication Critical patent/WO2004112653A2/fr
Publication of WO2004112653A3 publication Critical patent/WO2004112653A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body

Definitions

  • FIELD [0001] Described here are devices and methods for delivering, deploying, and forming prostheses having stenting properties within body lumens. More specifically, stent precursor structures, delivery assemblies, and methods for delivering and deploying stent precursor members to form stenting structures at a selected target site within a body lumen are described.
  • Stents are commonly used to maintain the patency of body lumens. For example, they are used in various arteries (e.g., coronary, peripheral, neck, and cerebral), in the veins, biliary ducts, urethras, ureters, fallopian tubes, bronchial tubes, tracheas, esophagi, and even prostrates. Stents are perhaps most often used in conjunction with angioplasty, to treat atherosclerosis, a cardiovascular disease characterized by the progressive narrowing and hardening ofthe arteries.
  • Angioplasty sometimes referred to as percutaneous coronary intervention (PCI), or percutaneous transluminal coronary angioplasty (PTCA) is a procedure in which a balloon (often placed on the distal tip of a catheter) is used to push back some ofthe plaque, which has built up on the artery wall.
  • PCI percutaneous coronary intervention
  • PTCA percutaneous transluminal coronary angioplasty
  • implanted stents help maintain the integrity of a lumen and prevent it from narrowing or closure. Because stents have provided continued lumen patency, and reduced rates of repeat revascularization, a number of different stent designs have emerged. Indeed, there are over 30 different stent designs currently in commercial use. These designs are often classified by their repeating pattern of metal construction (i.e., slotted tube, coil, or mesh), or by the nature of their delivery (i.e., self-expandable or balloon-expandable).
  • Exemplary commercial stents include the Palmaz-Schatz Crown stent, the NIR stent, the MultiLink Duet, the In-Flow GoldFlex stent, the Bestent, the Terumo stent, the Crossflex LC, the GFX stent, the Wallstent, and the Jostents (for bifurcated lesions).
  • a recurring problem with stenting in vascular sites is restenosis, or the re- narrowing ofthe stented artery lumen after stent implantation. About 40 percent of all patients having stent implantation suffer some degree of restenosis within six months ofthe implantation. Some believe restenosis to be caused by new vessel wall tissue growth triggered by injury occurring as a result ofthe angioplasty or stent implantation procedures. Vessels suffering from restenosis often require subsequent angioplasty or surgery.
  • stents eluting anti-proliferative or anti-inflammatory drugs have been developed. These stents appear to have reduced the rate of restenosis, however the long term effects ofthe eluted drugs on the body have not yet been determined.
  • these drug eluting stents were developed for use with traditional stents, such as those mentioned above, many of which, due to their size, shape, and method of deployment, remain undesirable for implantation in particular body lumens. Indeed, some ofthe above mentioned stents are of such a size, or are of such rigidity, that maneuvering them through tortuous vessels, or vessels having small circumferences is not only problematic, but virtually impossible. These issues are compounded when the vessels are in locations that are hard to access (e.g., intracranial vessels).
  • a major problem faced during stent implantation is maneuvering ofthe stent through the body's access passageways to a target site (e.g., a lesion) without causing injury.
  • a target site e.g., a lesion
  • the profile ofthe delivery assembly may approach the diameter ofthe stent itself.
  • the stent, folded or compressed to allow access through these passageways is quite stiff.
  • special care must be taken to minimize the possibility of dislodging plaque, which could potentially result in the formation of an embolism and hence a "vascular accident.”
  • the multiple stent precursor assembly may also comprise one or more clasps (e.g., an electrolytic clasp) releasably holding the stent precursor members so that they are not released from the bundle.
  • the stent precursor members may be configured to release a sequence of simultaneously released stent precursor members from the bundle.
  • the multiple stent precursor assembly comprises at least one stent precursor member that is self-forming into the stent structure.
  • the self-forming stent precursor member may comprises a super-elastic material, such as nickel-titanium alloys, copper-zinc alloys, and nickel-aluminum alloys. In some instances, the super-elastic material comprises nitinol.
  • the multiple stent precursor assembly comprises at least one stent precursor member that is self-expanding into the stent structure.
  • the self-expanding stent precursor member may comprise a super-elastic material, such as nickel-titanium alloys, copper-zinc alloys, and nickel-aluminum alloys.
  • the at least one stent precursor member comprises a plastic material and is of dimensions such that the at least one stent precursor member is plastically deformed upon forming the stent structure.
  • the plastic material may be those such as stainless steels, polyurethanes, ethers, acrylates, olefins, propylene, butenes, butadiene, styrene, and thermoplastic olefin elastomers, polydimethyl siloxane-based polymers, polyethyleneterephthalate, cross-linked polymers, non-cross linked polymers, rayon, cellulose, cellulose derivatives, nitrocellulose, natural rubbers, polyesters, lactides, glycolides, caprolactones and their copolymers and acid derivatives, hydroxybutyrate and polyhydroxyvalerate and their copolymers, polyether esters, anhydrides, hexadecandioic acid, and orthoesters.
  • the plastic material comprises stainless steel. In other variations, the plastic material comprises a polymer.
  • the at least one stent precursor member includes at least a first portion comprising a super-elastic material and at least a second portion comprising a plastic material and having dimensions such that the at least the second portion is plastically deformed upon forming the stent structure.
  • the at least one stent precursor member contains a drug, for example, anti-proliferation agents, anti-inflammatory agents, antibiotics, or immunosuppressants.
  • a drug for example, anti-proliferation agents, anti-inflammatory agents, antibiotics, or immunosuppressants.
  • Specific drugs suitable for use with the described devices include paclitaxel, methotrexate, batimastal, doxycycline, tetracycline, rapamycin, actinomycin, dexamethosone, methyl prednisolone, nitroprussides, estrogen, and estradiols.
  • the multiple stent precursor assembly comprises at least one guide member and more than one elongated stent precursor members that are situated distal end to proximal end and are releasdeably adherent to the guide member.
  • Each stent precursor member may be configured to be formable into a stent structure in the body lumen by a longitudinal movement with respect to a cooperating delivery element.
  • each stent precursor member is wire-like.
  • the stent precursor members is adherent to the guide member substantially along the length of that at least one stent precursor member.
  • the stent precursor members may be configured to release sequentially from the guide member.
  • the multiple stent precursor assembly may comprise one or more clasps that releasably hold the stent precursor members to the bundle.
  • FIG. IA is an illustration of an exemplary delivery device useful for delivering the stent precursor members described herein.
  • FIG. IB provides an exploded view of an illustrative stent precursor structure described herein.
  • FIGS. 2A-2I provide illustrative cross sections of stent precursor member configurations.
  • FIGS. 3A-3C provide various side and cross-sectional views of some illustrative stent precursor members described herein.
  • FIGS. 4A-4E provide illustrative views of various stent precursor members detachably coupled to guide members.
  • FIGS. 5A-5E provide side and cross-sectional views of various shape forming members described herein.
  • FIGS. 6 A and 6B show an illustrative stent precursor structure having multiple stent precursor members.
  • FIGS. 7A-7D show one variation in which a clasp may be used to hold the multiple stent precursor members in place prior to deployment.
  • FIGS. 8A-8B depict a typical electrolytic joint and its operation in a clasp to selectively release multiple stent precursor members.
  • FIGS. 9A-9D illustrate the use of multiple stent precursor members with a single guide member to form multiple stenting structures during a single procedure.
  • FIG. 9E provides a longitudinal sectional view of FIG. 9D.
  • FIGS. 1 OA-l 0B show various configurations of stent precursor structures having multiple stent precursor members.
  • FIG. 11 depicts a bundle of stent precursor members and its use as a guidewire.
  • FIGS. 12A-12D show various configurations in which the stent precursor member may be extended distally from a delivery device while the guide member is returned proximally.
  • FIG. 13 shows one variation ofthe described device with a balloon catheter.
  • FIGS . 14 A- 14E illustrate a typical method of using the described device with a balloon catheter.
  • FIGS. 15A-15D illustrate a method in which a balloon catheter may be used to deliver and deploy a stent precursor member.
  • FIGS . 16 A- 16D provide an illustration of one method of delivering and deploying stent precursor members to form stenting structures as described herein.
  • FIG. 17 provides an illustration of a balloon device that may be used to secure the stenting structure described herein to a wall of a body lumen.
  • stent precursor members may be delivered and deployed, as desired, within a number of body lumens and at many desirable target sites.
  • the stent precursor members may be delivered and deployed within a body lumen ofthe arterial system, such as a body lumen within the coronary arteries, the peripheral arteries, and the cerebral arteries.
  • the stent precursor members may be delivered and deployed in the prostate via the prostatic urethra, the fallopian tube via its lumen, and any other suitable body lumen.
  • the stent precursor members may be delivered to more than one target site, and deployed within more than one body lumen.
  • the target site may be a site within the body lumen where it is desirable to form a stenting structure.
  • the target site may be a stenotic or other diseased region.
  • the target site may also be one which has previously been treated, for example, by conventional angioplasty procedures, artherectomy, laser angioplasty, ultrasonic ablation, or even one that has been previously stented.
  • the target site may also be one that is suspected of being diseased.
  • FIG. 1 A shows a delivery device or assembly (100) useful in the delivery of our stent precursor structures.
  • FIG. 1 A shows one variation of a suitable delivery device (100) for delivering the stent precursor members in situ, here exemplified with a stent precursor member (114) and a guide member (116) to support the stent precursor member during delivery. The variation shown in FIG.
  • FIG. 1 A depicts a delivery device (100), such as a catheter, a microcatheter, or other delivery device, having a Y-port (102) thereon.
  • a delivery device such as a catheter, a microcatheter, or other delivery device, having a Y-port (102) thereon.
  • the combination of stent precursor member (114) and a guide member (116) are inserted into the delivery device (100).
  • the choice of delivery device e.g., size, etc.
  • the delivery device (100) may include one or more radio-opaque bands (104) at or near its distal end.
  • the delivery device (100) may be inserted into an entry point in the patient's body at a location remote from the target site. For example, in the case where the target site is within the vasculature, one typical entry point is into the femoral artery ofthe groin. In essence, the delivery device (100) forms a passage way between the treating physician and the target site.
  • the stent precursor structure in this variation having a stent precursor member and a guide member
  • the stent precursor structure is advanced past the distal end ofthe delivery device (100), and past the target site.
  • FIG. IB provides an exploded view ofthe distal end of stent precursor structure (110).
  • Stent precursor structure (110) comprises a delivery element (112) having a stent precursor member (114) releasably attached thereto.
  • the delivery element (112) is non-caged.
  • non-caged means that the stent precursor member (114) maintains its shape by a support, or other member, which is not in the form of a tubular restraint, such as a catheter or a sheath.
  • the stent precursor member (114) is capable of being pushed distally past the target site in a deployable form, and may even contact the walls ofthe body lumen, without being deployed.
  • the stent precursor structure (110) may optionally be secured to at least one guide member (116) along at least a longititudinal portion ofthe delivery element (112).
  • the stent precursor member (114) becomes a coiled or helical stenting structure after detachment from the delivery element (112) or guide member (116), for example, by the methods discussed below.
  • the stenting structure formed from the precursor member (114) comprises at least one turn, but the axial length, diameter, number of turns, and distance between adjacent turns can be controlled. Each turn need not have the same pitch or diameter as the previous one.
  • the stenting structure may comprise any number of turns and comprise any number of shapes (e.g., circles, ovals, ellipses, etc), however shapes allowing the outer diameter ofthe stenting structure to easily conform to the wall ofthe body lumen may be , more desirable. It is this flexibility of operation that permits some variations of this device to conform to a varying lumen wall diameter with such ease.
  • the stent precursor member (114) may be made of a variety of suitable materials and be of any of a wide number of configurations. Indeed, in certain instances, it may be desirable to have the stent precursor member constructed in such a way, and of such a material, that it is substantially self-forming.
  • self-forming means that the stenting structure formed when the stent precursor member (114) is detached from the delivery element (112) is of a predetermined configuration. This predetermined configuration for example, is determined prior to introducing the stent precursor structure into the delivery device (100).
  • a self-forming stent precursor member would be one comprising a superelastic alloy, or the like.
  • a "self-expanding" stent precursor member (a subset of “self-forming” members) may expand in diameter upon release without further action by the user.
  • a helical or coiled stenting structure may be pre-formed prior to introducing the stent precursor structure into the delivery device.
  • the stent precursor member (114) may be made “semi self-forming.” That is, at least one section ofthe stent precursor member may comprise a material that is self-forming, while other sections ofthe stent precursor member are not.
  • the stent precursor member (114) may also be "plastic" in nature. That is, the stent precursor member may be of such a size and be made of such a material, that when it is deployed to form the stenting structure at the target site within the body lumen, the forces associated with the deployment steps described herein below, will create plastic deformation in the stent precursor member (114).
  • the number and types of stent precursor members is only limited by the desired design and its subsequent utility. Any number of configurations, or combinations of configurations may be used. A few illustrative stent precursor member cross-sectional configurations are provided in FIGS. 2A-2I.
  • the stent precursor member may have a rod-like or cylindrical figuration as shown in FIG. 2 A, or it may have a rectangular configuration as shown in FIG. 2B.
  • the stent precursor member may have an oval or elliptical type configuration as shown in FIG. 2C, or it may have a configuration having flattened top and bottom portions, with rounded sides, as shown in FIG. 2D.
  • FIG. 2E shows another variation ofthe stent precursor member having a first central portion surrounded by second outer portion, e.g., one or more coatings.
  • the stent precursor member may have a central portion, comprising a plastic or super- elastic metal or alloy, and then be coated with a composition containing a biologically active agent or the like.
  • the coating may be a polymeric material having significant flexibility or, if desirable, the coating may comprise a harder material, providing less flexibility. While shown here in FIG. 2E as having a rod-like or coaxial cylindrical configuration, any number of shapes may be used, which allow for the use of multiple materials. For example, FIG.
  • FIG. 2F shows one variation in which the stent precursor member has a first top portion, and a second bottom portion.
  • the top and bottom portions may comprise different materials.
  • FIG. 2F illustrates a stent precursor member having a first top portion and a second bottom portion in a rectangular configuration, any number of shapes may be used.
  • FIG. 2G shows yet another variation ofthe stent precursor member in which the stent precursor member is twisted. That is, it may have one or more bends or turns, giving it somewhat of a helical configuration.
  • FIG. 2H shows a variation ofthe stent precursor member having a cable-like configuration. As shown in FIG. 2H, the stent precursor member can have a first inner portion, and a second outer portion comprising a multiplicity of smaller cylindrical configurations. This type of configuration may be advantageous for instance, to facilitate drug delivery.
  • each smaller cylindrical configuration may comprise a biocompatible polymer having a drug thereon. In this way, controlled and/or sustained drug delivery may be facilitated. Any number of biocompatible polymers and drugs may be used as described in more detail below.
  • FIG. 21 shows yet another variation in which the stent precursor member is made of more than one material, for example, longitudinally along its length.
  • a combination of materials may be used to design a stent precursor member having a variety of desirable properties.
  • the materials may be a combination of alloys, a combination of super-elastic alloys, various plastics or polymers, or a mixture of any ofthe above.
  • the dissimilar materials could be those having different coefficients of thermal expansion, forming, for example, a bimetal strip or section.
  • the stent precursor member may be configured to form a given shape once the stent precursor member reaches a given temperature, or range of temperatures.
  • Such sections may also comprise pre-formed , sections of shape-memory metals or alloys that change shape upon entering the warmth ofthe human body. ., . - -. ⁇ • ,
  • FIGS. 3 Ar3C show various side and cross-sectional views of exemplary stent precursor members having bends or undulations perhaps useful in anchoring the resulting stent structures at the desired body site.
  • the stent precursor member (111) is wire and has a bend (117) in a single plane, in a single direction.
  • FIG. 3B and 3C provide additional variations in which the stent precursor member is configured to have various other bending configurations.
  • a stent precursor member (113) having bends (117) in a single plane in two different directions is shown in FIG. 3B.
  • a stent precursor member (115) having bends (117) in two planes and directions, generally orthogonal is shown in FIG.
  • the bends need not necessarily be orthogonal to each other, of course. These types of configurations may be accomplished, for instance, by pre-bending a formable or plastic alloy, metal or other material or by the incorporation of more than one material into the stent precursor member. For example, a bi-metal section, a super-elastic alloy section, or combination of alloys may be used, which provide the deployed external configurations shown in FIGS. 3A, 3B, and 3C upon activation.
  • the stent precursor member (114) may be made from a variety of materials, and need not be made ofthe same material as the delivery element (112) or optional guide member (116). For example, any biocompatible, non-toxic material imparting any ofthe desired properties discussed above, such as flexibility, etc., may be used.
  • the stent precursor member (114) may me made of metals, metal alloys such as stainless steel, alloys having superelastic properties, polymers, or any of these in combination.
  • Examples of a suitable superelastic alloys include nickel titanium alloys (e.g., 48-58 atomic % nickel and optionally containing modest amounts of iron); copper/zinc alloys (38-42 weight % zinc); copper/zinc alloys containing 1-10 weight % of beryllium, silicon, tin, aluminum, or gallium; or nickel/aluminum alloys (36-38 atomic % aluminum).
  • nickel titanium alloys e.g., 48-58 atomic % nickel and optionally containing modest amounts of iron
  • copper/zinc alloys 38-42 weight % zinc
  • nickel/aluminum alloys 36-38 atomic % aluminum.
  • Widely used NiTi alloys, generally known as "nitinol,” are those described in U.S. Pat. Nos. 3,174,851 ; 3,351,463; and 3,753,700, each of
  • the stent precursor member (114), delivery element (112), and optional guide member (116) may also comprise or include a wide variety of synthetic and natural polymers, such as polyurethanes (including copolymers with soft segments containing esters, ethers and carbonates), ethers, acrylates (including cyanoacrylates), olefins (including polymers and copolymers of ethylene, propylene, butenes, butadiene, styrene, and thermoplastic olefin elastomers), polydimethyl siloxane-based polymers, polyethyleneterephthalate, cross-linked polymers, non-cross linked polymers, rayon, cellulose, cellulose derivatives such nitrocellulose, natural rubbers, polyesters such as lactides, glycolides, caprolactones and their copolymers and acid derivatives, hydroxybutyrate and polyhydroxyvalerate and their copolymers, polyether esters such as polydioxinone, anhydrides such as polymers
  • photoactivatable crosslinkable groups succinimidyl azido salicylate, succinimidyl-azidobenzoate, succinimidyl dithio acetate, azidoiodobenzene, fluoro nitrophenylazide, salicylate azides, benzophenone-maleimide, and the like may be used as photoactivatable crosslinking reagents.
  • the activatable material may also consist of a thin coating which can be activated by external forces such as laser, radio-frequency, ultrasound or the like, with the same hardening result taking place. These materials would allow for normal tissue ingrowth to take place.
  • the stent precursor member (114) may be coated, loaded, contacted with, or otherwise made to release a biologically active agent.
  • stent precursor member (114) may be coated with anti-proliferation agents, anti-inflammatory agents, antibiotics, immunosuppresants, as well as others, each of which may be used alone, or in combination with other active agents.
  • suitable active agent include paclitaxel, methotrexate, batimastal, doxycycline, tetracycline, rapamycin, actinomycin, dexamethosone, methyl prednisolone, nitroprussides, estrogen, estradiols, and the like.
  • the stent precursor member (114) and delivery element (112) may also include one or more radio-opaque materials, in order to help facilitate delivery and deployment ofthe stent precursor member to form a stenting structure.
  • radio-opaque materials include platinum, rhodium, palladium, rhenium, as tungsten, gold, silver, tantalum, or any alloys of these metals. Selection of an appropriate radio-opaque material, or combination of radio-opaque materials, may be made based on the degree of flexibility or stiffness desired.
  • the diameter ofthe precursor member used to form the stenting structure may be in the range of 0.0001 and 0.05 inches.
  • the stent precursor member is formed from a stainless steel or nitinol wire, which is to be additionally coated (e.g., with a radio-opaque material)
  • the diameter ofthe wire may be in the range of 0.001 to 0.02 inches.
  • the stenting structure may than have outer diameters ranging between 0.005 and 0.025 inches.
  • the diameter ofthe stenting structure formed in situ should be of an appropriate and sufficient size so that the stenting structure is held in place within the chosen lumen typically without substantially, or inappropriately, distending the lumen walls. In cases where the stenting structure is to be placed within the vasculature, it should be of a sufficient diameter to withstand the repetitive pulsing of the vascular system. However, as noted above, the diameter ofthe stenting structure need not be uniform along its length, it may be variable.
  • the stent precursor member (114) may be made detachable from the delivery element (112) and/or optional guide member (116) by a number of different mechanisms.
  • the stent precursor member, delivery element, or guide member may include a sufficient amount of one or more electrically conductive materials at a desirable point of detachment. In this way an electrolytic joint is formed and the stent precursor member (114) is made detachable from the delivery element or guide member, and a pre-selected length of stenting structure is achieved.
  • stent precursor member (114) may also be made sufficiently long so that it may be divided into a number of individual stenting structure, for example in the range of 2-5, or more.
  • Other suitable mechanisms of detaching the stent precursor member include the use of ultrasound, radio- frequency, screw-type connections, hydraulic detachment mechanisms, heat-activated thermoplastic containig joints, and mechanical detachment mechanisms, for example, those described in U.S. Pat. No. 5,234,437, to Sepetka, U.S. Pat. Nos. 5,250,071 and 5,312,415, to Palermo, U.S. Pat. No. 5,261,916, to Engelson, and U.S. Pat. No. 5,304,195, to Twyford et al.
  • FIG. 4A shows a structure (118) comprising stent precursor member (120) and a guide member (122).
  • a seam of adhesive or glue (124) is shown causing adherence between the stent precursor member (120) and the guide member (122).
  • the line of adhesive (124) is shown to be reasonably continuous, it may be either semi-continuous or at intervals along the length ofthe two members (120, 122). ,
  • the stent precursor member (120) is peeled away from its attendant guide member (120). This "peeling" may be done, for example, by using a catheter tip, perhaps with a forming member (as discussed in more detail below).
  • the adhering material be chosen with an eye towards maintaining the unseparated adhering material on the guide member (122). In this way, the guide member (122) will retain the adhering material thereon until later removal, so that the adhering material will not be released into the body lumen where the stenting structure is to be formed. This in turn minimizes the risk of creating embolisms.
  • Chemical treatments to modify the adherence of glues and other binding agents to substrates are well known, and may be used to enhance or lessen the adherence ofthe adhering material to the stent precursor member (120) or guide member (122).
  • FIG. 4B shows another combination (126) of a guide member (128) and stent precursor member (130).
  • the two elements (128, 130) are not joined together by an additional material, but, are instead, pieces that are separable from a single element having a separation or "tear" line (132) between the two sections.
  • a frangible joint is easier to provide for using readily moldable materials, such as thermoplastics.
  • such a section may be formed by rolling and punching a metallic pre-form (e.g., a wire or ribbon), despite the normally modest size ofthe stent precursor structure to be formed.
  • FIG. 4C shows still another variation (134) in which the stent precursor member (136) is functionally attached to the guide member (138) using a covering (140) of material designed to be left at the target site.
  • a covering (140) of material designed to be left at the target site.
  • the guide member (138) transporting and translating the stent precursor member is returned into the delivery device or delivery system once it releases the stent precursor member.
  • the arrangement shown in FIG. 4C is suitable for such variations, wherein the guide member (138) would typically be comparatively fairly flexible.
  • the covering (140) may be used to carry anti-restenosis drugs or the like or may be produced from biocompatible and body-fluid-soluble glue such as one comprising fibrin. Such materials may provide a pharmaceutical benefit, may help maintain the position ofthe resulting stenting structure within the body, or may simply be dissolved over time without causing particular harm.
  • FIGS. 4D and 4E show additional variations ofthe described guide-stent precursor member, which use either modest mechanical clamping action by the guide members respectively (142 and 144), or which utilize small amounts of an adhesive or positioning material (146) in slots or grooves (148) provided along the exterior surface ofthe guide member (142, 144).
  • the slots or grooves (148) are configured to allow placement ofthe stent precursor member (150) in each ofthe slots.
  • FIG. 4D shows a variation in which the slot is cut in a helical fashion around the outer edge of guide member (142). It should be apparent that this helical slot (148) aids in the delivery ofthe stent precursor member (150) as it forms the stenting structure at the target site within a body lumen.
  • a shape forming member may be used to provide curvature to the stent precursor member as it is being delivered. As described in more detailed below, as the stent precursor member is pulled across the shape forming member, the precursor bends, providing a curve or turn in the stent precursor member. In this way, the stent precursor member is formed into a shaped, e.g., coiled or helical, stenting structure.
  • the shape ofthe shape forming member is designed or selected depending on the desired shape ofthe stenting structure to be formed.
  • the shape forming member may be a wedge type of structure positioned on the outer surface of a delivery device, at or near its distal end.
  • the wedge type structure may have at least one slanted surface and at least one horizontal surface joined thereto. The joinder ofthe two surfaces defines an angle, the degree of which may be selected so as to impart a desired final diameter to the stenting structure to be formed.
  • FIGS. 5A- E Other suitable variations ofthe shape forming member are shown in FIGS. 5A- E.
  • the shape forming member is positioned at the distal end of a delivery device, such as a catheter.
  • Side, cross-sectional and top views are shown.
  • the shape forming members depicted in these variations may be formed, for example, by providing a shaped slot of sorts, which extends from the lumen ofthe catheter to its outer surface as shown in the cross-sectional views.
  • the shape forming member imparts at least one curve or bend to the stent precursor member in a given direction.
  • the shape forming member may be reversed to impart shape when the stent precursor is moved distally to the shape forming member.
  • the shape forming member (160) may be configured to provide a radial or tangential bend or direction to the stent precursor member pulled thereover.
  • the shape forming member (161) may be configured to provide a proximal bend or direction to the stent precursor member as depicted in FIG. 5B.
  • FIG. 5C provides another variation in which the shape forming member (163) has a keyhole-like configuration, having an initial slot that extends into a wider structure, in this variation, shown as a circle (164).
  • the circular structure (164) acts to capture the stent precursor member, and may therefore be designed to have dimensions that provide the final shape ofthe stenting structure desired to be formed.
  • FIG. 5D shows another variation, similar to that of FIG. 5 A, in which the shape forming member (165) provides a more radial or curved direction to the stent precursor member.
  • FIG. 5E shows yet another variation ofthe shape forming member, in which the angle imparted to the stent precursor member by the shape forming member may be made variable in situ during a stent forming procedure. As shown in FIG. 5E the shape forming member on the catheter has two portions, a distal portion (166) and a proximal portion (167).
  • the proximal portion ofthe shape forming member (167) is positioned on the distal portion (166) and, in this depicted variation, includes a funnel-like area that intercepts the stent precursor and directs it to a forming or contact surface on the proximal portion.
  • a contact surface Positioned along the proximal portion (167) is a contact surface, here shown as a series of ramps (169). In this variation, each ramp is shown to have a different angle such that when the stent precursor member contacts the ramp surface, a given angle of deflection (and hence, forming) is given to the stent precursor transforming it into a stent structure.
  • the proximal portion (176) ofthe catheter may be rotated or turned with respect to the distal section (166) as desired to facilitate contact ofthe stent precursor member with the desired ramp surface (169). In this way, the angle ofthe stent precursor member deflection may be adjusted in situ during the procedure. This permits adjustment ofthe size, pitch, etc. ofthe resultant stent structure without removal of the forming device from the body. , , . . .
  • One advantage of this variation ofthe described device is that multiple stenting structures may be formed in situ simultaneously or sequentially, without removing the stent precursor structure from the delivery system.
  • the device may form multiple stenting structures using any ofthe above described stent precursor structures, including those utilizing a guide member.
  • one device suitable for forming multiple stenting structures is depicted in FIGS. 6A and 6B.
  • the device (170) shown in FIG. 6 A comprises a guide member (172) and a number of stent precursor members (174, 176, 178).
  • the device (170) is designed to allow the simultaneous deployment of multiple precursor stent members (174, 176, 178) during a single deployment movement. That is to say, that multiple stent precursor structures are placed in the deployment device and then advanced distally within the selected body lumen. Those stent precursors are substantially parallel for at least a portion of their overall length.
  • stent precursors may be considered in some variations to be “wire-like.”
  • wire-like we mean that the in the central regions ofthe precursors, where the stent precursors are in general contact, the largest effective diameter (measurement across the broadest dimension ofthe stent precursor cross-section, e.g., as shown in FIGS. 2A to 2H) is less than about 0.200 inches, preferably less than about 0.100 inches.
  • the stent precursor members to be deployed are then deployed as they are pulled proximally past the target site in the body lumen to be treated. For instance, if the surgeon using the device shown in FIG.
  • each stent precursor member could have a dedicated shape forming member configured to contact the engagement region of its corresponding stent precursor member.
  • the assemblage (170) shown in FIG. 6A is simply, a multiplicity of a stent precursor members adherent to a guide member (172).
  • the distal ends of the multiple stent precursor members may be positioned to terminate at the same place (184) as is shown in FIG. 6A, or the distal ends of those stent precursor members may be staggered or, at least, not terminate at the same location on the guide member (172).
  • FIG. 6B is a cross-sectional view of the assemblage shown in FIG. 6A.
  • FIG. 7A shows an assembly (190) of multiple stent precursor members (192, 194, and 196) (192 is not shown in FIG. 7A, but visible in FIG. 7C and FIG. 7D).
  • the variation ofthe assembly shown in FIG. 7A has a number of bands, each holding one less stent precursor member than the clasp or band proximal to it. This allows the deployment ofthe outer most stent precursor member, reintroduction ofthe partially depleted assembly (190) to allow deployment of a second stent precursor member (194) after its associated clasp or band (200) has been opened, and finally deployment ofthe final stent precursor member (192) after its clasp or band (204) has been opened.
  • This sequence of events is shown in FIGS. 7A, 7B, and 7C, respectively.
  • FIG. 7D shows a cross-section ofthe initially introduced device as found in FIG. 7 A. Shown in FIG. 7D, are the guide member (202), clasp (204), clasp (200), and the three stent precursor members (192, 194, 196). Severing or opening clasps (200 and 204) may be readily performed using separate electrolytic joints, such as those described in detail below and shown in FIGS. 8 A and 8B.
  • FIGS. 8 A and 8B show how an electrolytic joint may be used in conjunction with the above described clasps.
  • the clasp (205) has an electrolytic joint (206).
  • An electrically conductive wire (208) is used to transfer electricity from an external power supply (+V) to the electrolytic joint.
  • the wire (208) may be constructed of a material so that it is insulated from the electrolytic joint itself.
  • FIGS. 9A-9D illustrate how multiple stent precursor members may be used with a single guide member to form multiple stenting structures during a single procedure, using for example, electrolytic clasps ofthe type described above.
  • stent precursor members 250, 252, and 254 are releasably attached to guide member (256) using for example, one or more electrolytic clasps (258) as described above.
  • the assembly (259) of multiple stent precursor members (250, 252, 254) and guide member (256) is then advanced distally into the lumen (262) of a delivery device (260).
  • the lumen (262) is configured to accept three corresponding stent precursor members, however, the lumen may be designed so as to accept more or less, for example, from 2-5 stent precursor members.
  • the delivery device (260) has one or more ports (264) or openings thereon for receiving at least one stent precursor member therethrough.
  • the stent precursor member (250) exits port (264).
  • the assembly (259) is then withdrawn proximally and the electrolytic clasp (258) is dissolved, releasing stent precursor member (250) to form a stenting structure in situ.
  • the guide member (256) in this variation acts as an indexing medium between the delivery device (260) and the assembly (259).
  • the assembly (261), having one less stent precursor member, may then be advanced distally, to delivery and deploy a second stent precursor member (252).
  • Stent precursor member (252) is advanced distally where it exits port (266).
  • the stent precursor member (252) is deployed and begins to form a stenting structure.
  • the electrolytic clasp is then dissolved.
  • the assembly (263), having only one remaining stent precursor member (254) may be advanced distally to deliver and deploy stent precursor member (254). As the assembly is withdrawn proximally, stent precursor member (254) is deployed. The last electrolytic clasp is then dissolved, releasing stent precursor member (254) and allowing it to form a stenting structure in situ. While the variations shown in FIGS. 9A-9D illustrate three different ports (264, 266, 268) for receiving three different stent precursor members (250, 252, and 254 respectively), this need not be so. For example, a single port may be used to receive each ofthe stent precursor members employed.
  • FIG. 9E provides a longitudinal sectional view of FIG. 9D; " ,
  • FIGS. 10A and 10B show additional variations ofthe described device configured to release multiple stent precursor members.
  • FIG. 10A shows an assemblage (210) having a guide member (212) and a first stent precursor member (214).
  • Second stent precursor member (216) is shown to be separated from the distal end (218) ofthe first stent precursor member (214). This configuration allows the user to fully deploy stent precursor member (214) completely before beginning deployment of stent precursor member (216).
  • the stent precursors may be ofthe normal columnar configurations, e.g., tubular in form and constructed of wire, tubes, or rolled and welded, and delivered as shown.
  • tubular stent precursors specifically as tubular stent precursors.
  • FIG. 10B similarly shows in schematic fashion, a guide member (212), a first stent precursor member (220), a second stent precursor member (222), and an additional stent precursor member (224).
  • the next-trailing stent overlaps the proximal end ofthe leading stent by a certain distance, to allow the user to begin deploying the following stent after the more leading stent is finished with its deployment.
  • FIG. 11 shows an assembly (230) in which a bundle (232) of stent precursor members (234) are bound together, in a way similar to those discussed elsewhere here, which may achieve the function of a guide wire.
  • a guide member (235) is shown to support the bundle (232) of stent precursor members. This variation allows access ofthe device into areas having modest, perhaps minimal clearance, as might be found in the neural vasculature.
  • the structure (230) shown in FIG. 11 includes the bundle (232) of multiple stent precursor members (234) bound together as discussed above. Additionally, a sleeve (240) with an attendant handle (242) is shown. The sleeve (240) may slide over the proximal end of the assembly (232) of multiple stent precursor members (234). Catheter (244) designed to approach a lesion or other target site within a body lumen is shown with the distal portion (246) of bundle (232) emanating from its distal end. A pair of radio-opaque bands (248) may be placed at or near the distal end of catheter (244) to allow a user to determine where the distal end may be during a selected procedure, via fluoroscopy.
  • FIGS. 12A-12D show a variation ofthe described device in which the stent precursor member is extended distally from a delivery device of some kind, while the support or guide member is returned proximally from the point where (or, at least near) the stent precursor member is separated from the guide member.
  • This arrangement has certain benefits, the major one of which may be, that the stent precursor structure or any of its components, need not be advanced significantly past the target site.
  • the delivery element or the guide member may pass the target site for a significant distance before deployment ofthe stent precursor member at that site.
  • FIG. 12A shows one variation ofthe disclosed device (300) in which the delivery member (302) is shown to be a catheter, or the like, having a separator wall (304) near its distal end. Separator wall (304) allows the guide member (306) to separate from the stent precursor member (308) and to pass back to the proximal end ofthe delivery device. The guide member or delivery element (306) is pulled in a proximal direction (310) allowing a separation or a release ofthe precursor stent element (308).
  • FIG. 12B shows a similar assembly (312) in which the guide member (314) passes around a circular turning post (316) to provide separation between the guide member (314) and the stent precursor member (318).
  • the turning post (316) may be of any convenient shape allowing such a separation and lowering the overall friction ofthe turning operation. If convenient, the mrning post (316) may rotate.
  • the distal end ofthe delivery member (320) is shown to have a directing member (322) located distally, to direct the stent precursor member (318) to the target site.
  • the directing member (322) may be of any convenient size or direction allowing or enhancing movement ofthe stent precursor member towards the wall ofthe target site.
  • FIG. 12C shows another assembly (326) in which the delivery device comprises a catheter body (328).
  • the guide member (330) is returned to the operator without the tubular member. Again, pulling the guide member (330) in a proximal direction (332) permits the stent precursor member (334) to exit the delivery device in a proximal direction (336).
  • the guide members in the variations discussed in regard to FIGS. 12A-12D may be significantly more flexible than other ofthe guide members discussed herein.
  • the guide member provides significant independent support to the stent precursor member.
  • the support member in this variation desirably has significant shear strength when pulled from one end to the other, but may not have, for example, significant inherent stiffness. - .
  • FIG. 12D shows a structure (350) that is comparably stiff in some ways to a typical cardiovascular or neurovascular guide or catheter.
  • the proximal portion (352) ofthe assembly (350) desirably has internal walls (354) supporting an interior tubular portion (356) through which the stent precursor member (358) and the attached guide member pass.
  • the variation shown in FIG. 12D includes an extension (356) that extends through the central passageway.
  • Such a structure, with its low diameter nose piece (356) extending distally from the larger and stiffer main body section (352), may provide several advantages.
  • the low diameter extension (356) may be extended into, and even distally of, a lesion or target site and may provide stiffness when the guide member (360) is pulled proximally to detach the stent precursor member.
  • FIG. 13 shows a device (400) made up of a balloon catheter (420) and a tubular member (422) that is able to slide and to rotate within the inner bore of balloon catheter (420).
  • the stent precursor member (424) and the guide member (426) are also shown.
  • This variation may have a number of advantages that could be quite useful depending upon the circumstances of use. For instance, if the diameter ofthe lumen selected for treatment is quite variable, this variation includes a small balloon catheter that may be used to tailor or to size the stenting structure deployed at the target site.
  • the inner tubular area (422), in addition to being used as a delivery element for separating the stent precursor member from the guide member, may also be used, in the manner of a guide "wire” and the deflated balloon catheter (420) may follow it into the region where the stenting structure was formed. The balloon may then be used to tailor the diameter ofthe resulting stenting structure, if desired.
  • FIG. 14A depicts a lumen varying body organ such as an artery.
  • a lesion (430) is shown interior to the artery.
  • the stent precursor member (428) is shown to be introduced distally past lesion (430).
  • Attached guide member (426) is also shown.
  • the inner tubular catheter member (422) that serves, in this instance, as the delivery element has been extended distally past the target site (430) as well.
  • Deflated balloon catheter (420) is shown proximal ofthe target site (430). In this variation, the balloon catheter (420) may be inflated to provide a specific amount of proximal/distal immobility to the resulting device.
  • the tubular member (422) is drawn proximally, towards the operator, and the guide member (426) is similarly drawn proximally so that the stent precursor member (428) is cleaved from the guide member (426) and forms a stenting structure within the artery lumen. As shown in FIG. 14C, the guide member (426) and the inner tubular member (422) are withdrawn proximally as well. Since support is no longer needed, the balloon catheter (420) is deflated. Stent precursor member (428) has become a stenting structure. .
  • the inner tubular member may be used as a guide (as shown in FIG.. 14D) for balloon catheter (420).
  • the balloon catheter (420) is inflated to reform the shape ofthe stenting structure.
  • FIG. 14E shows the modified stenting structure (428)..
  • the balloon catheter (420) and the tubular member (422) are then withdrawn from the target site.
  • This variation provides significant operational flexibility in that the small tubular member may be introduced through the treatment area for aiding in the longitudinal placement ofthe stenting structure.
  • the central tubular member may also be used to provide a good passageway and direction for the balloon "clean up," should one be needed.
  • FIGS. 15A-D illustrate additional methods in which a balloon catheter may be used to deliver and deploy stent precursor members.
  • a delivery device (432) (e.g., a catheter) having an expandable balloon (434) thereon may be advanced distally through a body lumen toward a target site (436) for treatment.
  • the balloon (434) is in a collapsed, deflated configuration.
  • a guide member (438) having a stent precursor member (440) releasably attached thereto is advanced distally through the lumen of delivery device (432).
  • the stent precursor member (440) is advanced within the delivery device (432) until its engagement region (442) engages an opening or port within the delivery device, which allows it to exit the device near the proximal end ofthe deflated balloon (434).
  • the guide member (438) is pulled proximally causing the engagement region (442) to contact a shape forming member (444) positioned near the proximal end ofthe deflated balloon (434).
  • the stent precursor member (440) contacts the shape forming member (444) which provides curves or bends in the stent precursor member (440), thereby forming a helical or coiled structure that surrounds the collapsed balloon (434) as it is formed.
  • the delivery device having the collapsed balloon with the surrounding coiled structure thereon is then advanced distally toward the target site (436). Once the balloon is positioned across the target site (436), the balloon may then be expanded as shown in FIG. 15C. Appropriate positioning ofthe balloon may be accomplished by any ofthe fluoroscopy-aided techniques discussed elsewhere.
  • the inflation ofthe balloon expands the lumen ofthe stenting structure (446) until its outer circumference gently contacts the walls ofthe target site.
  • Suitable techniques for balloon inflation are well known in the art, and any such suitable techniques (e.g., use of pressured saline, etc.) may be used with the methods described here.
  • the balloon can be collapsed to fts first non-expanded configuration as shown in FIG. 15D.
  • the delivery device (432) may then be removed from the patient by withdrawing the device proximally.
  • FIG. 15 A shows one variation in which the stent precursor member exits an opening or port ofthe delivery device
  • the stent precursor member need not begin forming a stenting structure in this fashion.
  • the stent precursor member may be advanced distally past the distal end ofthe delivery device (432) as shown by the dashed lines in FIG. 15 A.
  • the engagement region ofthe stent precursor member contacts a shape forming member (not shown in this drawing) located perhaps at the distal-most portion of catheter (432) or between the distal end of the catheter and the balloon (434) and begins to form a stenting structure, in a proximal direction.
  • FIGS. 16A-D illustrate additional variations of delivering and deploying the stent precursor members described herein.
  • the target site (500) may be reached using a delivery device (502) having one or more radio-opaque markers (504) positioned on or near its distal end.
  • catheters e.g., microcatheters, neurovascular catheters, etc.
  • guides may optionally be used to effectuate the procedure.
  • the length and diameter of these optional catheters and guides is chosen based upon the location and size ofthe target site selected for treatment.
  • the catheter may have a length between 50-300 cm, and a diameter ranging between 8- 30 mils or more.
  • the optional catheter may have one or more lumens for the introduction or delivery of heated fluids (e.giller to induce expansion of shape memory alloys) and may be made of any suitable biocompatible material.
  • suitable materials include extruded polymeric materials, such as polyolefins, particularly the polyethylenes, and including other polymers including polyethyleneterephthalate, polyamides, polyesters, polyurethanes, polyvinylchlorides, and the like. Catheters meeting these specifications are well known in the art and are commercially available.
  • suitable guidewires for use with such catheters are commercially available.
  • These guides generally comprise an elongate wire having a tapered, wire-wound distal end region adapted to be advanced through a tortuous path.
  • the entry point for delivery may be the femoral artery in the groin.
  • other entry points for example, the neck, are known in the art are also suitable.
  • the stent precursor structure may than be inserted through its lumen.
  • the stent precursor structure may be of a selected desirable length, and may be selected for example, based upon the length ofthe stent precursor structure required to reach the target site, and the length of stent precursor member required to form a stenting structure of a desirable size.
  • the stent precursor structure (506) is then advanced distally down the lumen ofthe delivery device, toward the target site (500) as shown in FIG. 16A.
  • the method of forming a stenting structure in situ generally comprises the steps of advancing the stent precursor member (508) distally past the target site (500) and releasing it to form a stenting structure (510) at the target site (500) .
  • angioplasty may optionally be employed prior to the delivery and deployment ofthe one or more stent precursor members. In this way, the body lumen may be widened prior to the formation of a stenting structure at the target site.
  • the stent precursor structure (506) is advanced distally past the target site (500).
  • the delivery device (502) may be pulled proximally as illustrated in FIG. 16B.
  • Proper positioning ofthe stent precursor member (508) may be accomplished by the use of a radio-opaque material, such as those described in detail above.
  • a radio-opaque material such as those described in detail above.
  • the stent precursor member (508) is detached from the optional guide member (512) by any ofthe detachment means discussed above, leaving the stenting structure (510) situated across the target site (500), as shown in FIG. 16D.
  • the delivery device (502) can be configured to transmit an electrical impulse to detach the stent precursor member (508) from the optional guide member (512).
  • the stenting structure (510) can.be formed so as to have a variable diameter, such that each turn is in contact with, a portion ofthe target site, helping to maintain the patency ofthe body lumen. ⁇ > . ,. ⁇
  • a balloon (520) may optionally be used to ensure the stenting structure (522) is adequately secured to the walls ofthe target site.
  • the balloon is inserted (e.g., on the tip of a balloon catheter) through the lumen ofthe stenting structure (522), and then expanded (e.g., using pressurized saline, etc.).
  • the balloon expands to contact the walls of stenting structure (522) and provides a gentle force on the stenting structure walls. This in turn helps anchor the stenting structure (522) to the walls ofthe target site, within the body lumen.
  • any number of stent precursor members may be delivered and deployed in using the methods described herein to provide any number of stenting structures.
  • multiple stenting structures may be delivered on top of one other, in order to strengthen the walls ofthe body lumen.
  • multiple stenting structures may be formed adjacent to one another, across the length of a single target site or lesion.
  • multiple stent precursor structures having multiple stent precursor members may be used to form multiple stenting structures as described above.
  • the stenting structures formed from the multiple stent precursor structures may be formed simultaneously, but need not be. As in the case when a single stent precursor structure is used, the stenting structures formed from multiple stent precursor structures may be delivered to the same or to different target sites.
  • stent precursor structures, stenting structures, and delivery systems described herein may also be used as a kit with other implantable devices. Modifications and variations ofthe device and methods described herein will be apparent to those having skill in the art, and are intended to be within the scope ofthe claims that follow.

Abstract

L'invention concerne des dispositifs et des procédés pour l'apport et le déploiement, dans des lumières corporelles, de prothèses, généralement de prothèses multiples, qui possèdent des propriétés d'endoprothèse. Plus spécifiquement, l'invention concerne des structures précurseurs d'endoprothèse, des ensembles et des procédés d'apport et de déploiement d'éléments précurseurs d'endoprothèse permettant de former in situ, dans une lumière corporelle, des structures d'endoprothèse en un site sélectionné. Dans certaines variantes, les éléments précurseurs d'endoprothèse sont faits de matières superélastiques, et dans d'autres variantes, de matières plastiques. L'élément précurseur d'endoprothèse peut éventuellement être chargé ou revêtu d'un agent biologiquement actif, ou permettre d'une autre manière la libération d'un tel agent. La structure précurseur d'endoprothèse peut éventuellement comprendre un élément guide qui soutient les éléments précurseurs d'endoprothèse. Dans certaines variantes, l'élément guide est fait de matières superélastiques ou de matières plastiques. L'invention concerne aussi des dispositifs et des procédés d'apport d'éléments précurseurs d'endoprothèse multiple permettant de former de manière séquentielle et simultanée des structures d'endoprothèse multiple.
PCT/US2004/019517 2003-06-18 2004-06-18 Dispositifs et procedes pour l'apport et la formation in situ de structures d'endoprotheses individuelles et multiples WO2004112653A2 (fr)

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US48069003P 2003-06-18 2003-06-18
US60/480,690 2003-06-18
US48609603P 2003-07-07 2003-07-07
US60/486,096 2003-07-07
US49124303P 2003-07-31 2003-07-31
US60/491,243 2003-07-31
US10/636,877 2003-08-06
US10/636,877 US20040260380A1 (en) 2003-06-18 2003-08-06 Devices for delivering multiple stenting structures in situ
US10/636,927 2003-08-06
US10/636,927 US20040260381A1 (en) 2003-06-18 2003-08-06 Devices and methods for forming stenting structures in situ

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