WO2002087656A2 - Methods and apparatus for delivering, repositioning and/or retrieving self-expanding stents - Google Patents

Methods and apparatus for delivering, repositioning and/or retrieving self-expanding stents Download PDF

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Publication number
WO2002087656A2
WO2002087656A2 PCT/US2002/013619 US0213619W WO02087656A2 WO 2002087656 A2 WO2002087656 A2 WO 2002087656A2 US 0213619 W US0213619 W US 0213619W WO 02087656 A2 WO02087656 A2 WO 02087656A2
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WO
WIPO (PCT)
Prior art keywords
stent
catheter
balloon
thermal transfer
ofthe
Prior art date
Application number
PCT/US2002/013619
Other languages
French (fr)
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WO2002087656A3 (en
Inventor
Dmitry J. Rabkin
Eyal Morag
Ophir Perelson
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Intek Technology L.L.C.
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Publication date
Application filed by Intek Technology L.L.C. filed Critical Intek Technology L.L.C.
Priority to AU2002305289A priority Critical patent/AU2002305289A1/en
Priority to EP02734100A priority patent/EP1389977B1/en
Priority to DE60236725T priority patent/DE60236725D1/en
Priority to AT02734100T priority patent/ATE471128T1/en
Publication of WO2002087656A2 publication Critical patent/WO2002087656A2/en
Publication of WO2002087656A3 publication Critical patent/WO2002087656A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22035Gripping instruments, e.g. forceps, for removing or smashing calculi for retrieving or repositioning foreign objects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9528Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9534Instruments specially adapted for placement or removal of stents or stent-grafts for repositioning of stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0023Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply

Definitions

  • the present invention generally relates to advanced medical endoluminal devices and methods of minimally invasive treatment of blockages ofthe blood vessels and other tubular organs. More particularly, the present invention relates to methods and apparatus for delivering, repositioning and/or retrieving self-expanding stents for internal reinforcing of diseased tubular structure and/or for local delivery of pharmacological or radioactive agents having a beneficial advantage of reduction of re-stenosis.
  • a stent is a generally longitudinal cylindrical device formed of biocompatible material, such as a metal or plastic, which is used in the treatment of stenosis, strictures, or aneurysms in body blood vessels and other tubular body structures, such as the esophagus, bile ducts, urinary tract, intestines or tracheo-bronchial tree. References hereafter to blood vessels and vessels will be understood to refer to all such tubular body structures.
  • a stent is held in a reduced diameter state during its passage through a low profile catheter until delivered to the desired location in the blood vessel, whereupon the stent radially expands to an expanded diameter state in the larger diameter vessel to hold the vessel open.
  • radial expansion ofthe stent may be accomplished by an inflatable balloon attached to a catheter, or the stent may be ofthe self-expanding type that will radially expand
  • Intimal hyperplasia is part ofthe endothelialization process by which the stent becomes incorporated into the vessel wall as a result ofthe vessel's reaction to a foreign body, and is characterized by deposition of cell layers covering the stent. It eventually results in formation of a neointima, which coats the stent and buries it completely in the vessel wall.
  • Endothelialization generally improves patency rates and the more complete the apposition ofthe stent to the vessel wall, the more uniform and optimal is the degree of endothelialization.
  • a fundamental concern is that the stent be deployed in the correct desired location in the vessel as precisely as possible in the first place. This is important when delivering radiation or medication to a particular location using the stent.
  • a stent be deployed in the correct desired position in the blood vessel and, secondly that the stent be as completely apposed to the vessel wall as possible.
  • Stents fall into one of two categories based on their mechanism of deployment and radial expansion, namely, balloon-expandable stents and self-expanding stents.
  • Balloon-expandable stents are mounted in their reduced diameter state on nylon or polyethylene balloons, usually by manual crimping, while others are available pre-mounted.
  • BES Balloon-expandable stents
  • U.S. patent 4,733,665 to Palmaz One example of a BES is shown in U.S. patent 4,733,665 to Palmaz.
  • BES rely solely on balloon dilation to attain the desired expanded configuration or state. This enables BES to be deployed in a relatively controlled gradual manner.
  • BES in general have more strength than self-expanding stents and initially resist deformation as well as recoil. BES behave elastically but eventually yield and become irreversibly, i.e. plastically, deformed under external force.
  • BES are less flexible than self-expanding stents and are therefore less capable of being delivered through tortuous vessels and, when a BES is deployed in a tortuous vessel, it often straightens the vessel, forcing the vessel to conform to the shape of the stent rather than vice versa. This generally results in portions ofthe stent not being
  • BES can generally be deployed in a relatively precise manner at the correct desired location in the vessel since they can be deployed in a controlled gradual manner by gradually controlling the inflation ofthe balloon.
  • SES Self-expanding stents
  • shape-memory alloy such as nitinol
  • Nitinol is an alloy comprised of approximately 50% nickel and 50% titanium. Nitinol has properties of superelasticity and shape memory. Superelasticity refers to the enhanced ability of material to be deformed without irreversible change in shape. Shape memory is the ability of a material to regain its shape after deformation at a lower temperature. These physical properties of nitinol allow complex device configurations and high expansion ratios enabling percutaneous delivery through low profile access systems.
  • Superelasticity and shape memory are based on nitinol' s ability to exist in two distinctly different, reversible crystal phases in its solid state at clinically useful temperatures.
  • the alignment of crystals at the higher temperature is called the austenite (A) phase; the aligmnent of crystals at the lower temperature is called the martensite (M) phase.
  • A austenite
  • M martensite
  • In between is a temperature interval of gradual transition between the A and M phases.
  • the shape of a nitinol device can be greatly deformed without irreversible damage.
  • superelastic or shape memory effects prevail. In close vicinity to or above the temperature
  • the device retains its deformed shape even after the external force is removed as long as the temperature ofthe environment stays below the temperature of transition into A phase. Only during heating does the device resume its original shape.
  • shape recovery occurs only upon heating the alloy to a temperature defining transition to the full A phase, by subjecting the alloy itself to a biasing force, i.e. an internal stress formed by dislocations introduced by plastic deformation in the alloy, a two-way shape memory can be imparted to the alloy so that cooling the alloy will induce a shape change.
  • a biasing force i.e. an internal stress formed by dislocations introduced by plastic deformation in the alloy
  • One type of self-expanding stent is constructed of wire formed of a shape-memory alloy, such as nitinol, having a transition temperature of about body temperature, i.e. 37°C.
  • a shape-memory alloy such as nitinol
  • the one-way transition temperature is the temperature of transformation of a nitinol device from its collapsed state into a fully expanded configuration.
  • the stent is pre-loaded on a low profile catheter by crimping the stent at room temperature (at which it can be plastically deformed) onto the catheter.
  • An outer sheath covers the crimped stent and at least partially thermally insulates the stent as it is delivered to the desired location.
  • the sheath Upon reaching the desired location, the sheath is withdrawn and the stent is exposed to body temperature whereupon it is naturally warmed to body temperature and expands to its expanded diameter state in supporting contact with the vessel wall.
  • the stent In a fully expanded state within the human body, the stent is capable of exerting considerable radial force on the surrounding structures, which allows mechanical opening ofthe vessel lumen and maintaining its long-term patentcy for free passage of flow.
  • the SES must be heated after release into the body. If shape recovery occurs below body temperature, the device may be cooled during the delivery to prevent expansion inside the delivery catheter. If shape recovery occurs at body temperature, no heating or cooling is necessary during the delivery and deployment, provided delivery is relatively speedy. If, however, a tortuous iliac anatomy or other interference delays prompt deployment of a nitinol stent with these characteristics, premature warming to body temperature could cause expansion in the delivery sheath, increase friction, and interfere with delivery. In this instance, flushing with a cool solution has been suggested.
  • SES do not require any special preparation prior to deployment. SES behave elastically throughout their lifetime, and do not become irreversibly deformed. When deployed, the nominal diameter is purposely selected to be greater that the diameter ofthe vessel. Therefore, once deployed, an SES exerts continuous outward force on the vessel as it tries to expand to its original dimensions. The ability of an SES to continuously exert an outward force on the vessel coupled with the greater flexibility of SES, generally results in optimal wall apposition, thereby optimizing endothelialization and improving patency rates. Nitinol self-expanding stents have been designed having good radial and hoop strength.
  • a malpositioned stent often requires an additional stent placement to correct the mistake and acliieve the desired results.
  • the stents will remain in the vessel for the entire life
  • the stent will become the site of recurrent stenosis due to an aggressive neointimal proliferation.
  • These patients require repeated interventions, which often include balloon angioplasty and/or additional stent placement.
  • stents coated with a drug called rapamycin essentially eliminates re-stenosis.
  • Other medications such as nitric oxide and paclitaxel or similar compounds, also have a potential to prevent proliferation of scar tissue by killing such cells.
  • radioactive stents to prevent re-stenosis is an additional area of active research, since local radiation has been shown to inhibit the growth of neointima and halt the progression of atherosclerotic disease.
  • an optimal stent and associated delivery method should possess and combine all the positive traits mentioned so far in each ofthe stent categories.
  • the stent should be pre-loaded on the delivery apparatus and should not require special preparation. It should be flexible to enhance apposition to the vessel wall. It should provide a controlled gradual deployment without stent migration to ensure deployment ofthe stent in the correct location.
  • the system should have the option of enabling repositioning and/or retrieval ofthe stent.
  • SES can be preloaded on the delivery apparatus, do not require special preparation and are flexible.
  • no satisfactory method or apparatus is available for obtaining a controlled gradual deployment of an SES without stent migration, or for repositioning and/or retrieving a SES. While methods have been suggested in the prior art for
  • a method for delivering, repositioning and/or retrieving an SES formed of a two-way shape memory alloy capable of expansion or collapsing in the radial direction in accordance with changes in temperature is disclosed in U.S. patent 5,037,427 to Harada et al.
  • a stent is made of nitinol alloy trained to have two-way shape memory.
  • the stent is in an expanded diameter state at about body temperature and in a reduced diameter state at a temperature below body temperature.
  • the stent is mounted in the reduced diameter state at the distal end of a catheter over a portion ofthe catheter having a number of side ports.
  • Cooling water supplied through the catheter flows out from the side ports and is brought into contact with the stent during delivery to maintain the stent below body temperature and therefore in the reduced diameter state.
  • the supply ofthe cooling water is stopped and the stent is warmed by the heat ofthe body and expands into supporting engagement with the wall ofthe vessel.
  • the catheter is then withdrawn.
  • the distal end portion ofthe catheter is inserted into the expanded stent lumen and a cooling fluid is introduced into the catheter and discharged through the side ports at the distal end region into the vessel whereupon the stent is cooled and purportedly collapses onto the distal end
  • the stent is retrieved by withdrawing the catheter.
  • the patent suggests that the position ofthe stent can also be changed using this technique.
  • U.S. Pat. No. 5,746,765 to Kleshinski, Simon, and Rabkin also discloses a stent made from an alloy with two-way shape memory, which expands inside the vessel due to natural heating to body temperature.
  • the stent is covered with an elastic sleeve. When the metal frame is softened by decreased temperature, the sleeve overcomes its radial force and promotes its further contraction for easier retrieval.
  • U.S. Pat. No. 6,077,298 to Tu et al. discloses a retractable stent made from a one-way shape-memory alloy, such as nitinol, that can be deployed into the body by means of dilation with a balloon catheter.
  • a radio frequency current within the range of 50 to 2,000 kHz must be applied directly to the stent to provide partial collapse ofthe stent after it is heated to a temperature above 43°C to 90°C.
  • U.S. Pat. No. 5,961,547 to Razavi disclose temporary or retractable stents in the shape of a spiral coil or a double helix.
  • these stents are made of different materials, such as metal or plastic, and have differences in the techniques of their deployment (heat-activated, self-expanding or balloon expandable), as well as methods of their retrieval (mechanical straightening vs. softening by increasing temperature vs. latch retraction), all of them have one common feature.
  • the stents are connected with a wire extending outside the patient at all times and when they have to be removed, they are simply retracted back into the catheter with or without prior softening ofthe material.
  • U.S. Patent No. 5,941,895 to Myler et al. discloses a removable cardiovascular stent with engagement hooks extending perpendicular to the axis ofthe stent into the vessel lumen.
  • the stent retrieval technique requires introduction of an extraction catheter, which is adapted to grasp the engagement hooks ofthe stent with subsequent stent elongation in axial direction ' and reduction of its cross-sectional diameter.
  • This stent is designed for predominant use in the human urethra and is not suitable for cardiovascular applications due to very large metal surface that could be thrombogenic and increased size ofthe delivery system.
  • the stent can be removed from the body with the help of a cannula or pincer grips for grasping the edge of the stent. By rotating the pinched stent, the pincer or cannula causes the stent to telescopically coil into smaller diameter, which can then be retrieved from the urethra.
  • U.S. Patent No. 5,562,641 to Flomenblit et al. discloses a spiral or cylindrical stent made from alloy with two-way shape memory capabilities.
  • the stent expands inside the body by heating to the temperature of 50°C to 80°C with an electric current, injection of hot fluid, external radio frequency irradiation or use of radio frequency antenna inside the catheter.
  • the stent can be removed from the body after cooling to a temperature, ranging from -10°C to +20°C, at which the stent partially collapses in diameter and can be grasped with a catheter for retrieval.
  • Another object ofthe present invention is to provide new and improved methods and apparatus for delivering self-expanding stents to desired locations in body vessels by which the stent can be deployed in a controlled gradual manner to thereby enhance the accuracy of
  • Still another object ofthe present invention is to provide new and improved methods and apparatus for delivering self-expanding stents to desired locations in body vessels by which the stent can be deployed in a controlled gradual manner safely without infusing a cooling liquid directly into the vessel or otherwise affecting general body temperature or
  • Yet another object ofthe present invention is to provide new and improved methods and apparatus for delivering self-expanding stents to desired locations in body vessels which eliminate the possibility of migration ofthe stent during deployment.
  • a further object ofthe present invention is to provide new and improved methods and
  • apparatus for repositioning and/or retrieving self-expanding stents in and from a body vessel without infusing a cooling or heating liquid directly into the vessel or otherwise affecting general body temperature or causing systemic affects.
  • a still further object ofthe present invention is to provide new and improved methods and apparatus for repositioning and/or retrieving self-expanding stents which eliminates the possibility of migration ofthe stent during repositioning.
  • a still further object ofthe present invention is to provide new and improved methods and apparatus for providing supplemental balloon angioplasty after stent deployment with the same system, eliminating the need for exchanging catheters.
  • a method and apparatus for delivering a self-expanding stent formed of a shape memory alloy to a desired location in a body vessel by placing the stent in a collapsed condition in contact, or in other local heat transfer relationship, with a thermal transfer device coupled to a catheter assembly, and delivering the stent in its collapsed condition to the region ofthe desired location in the body vessel while in contact or other local heat transfer relationship with the thermal transfer device.
  • the temperature ofthe thermal transfer device can be controlled in a safe and non-invasive matter so that the expansion ofthe stent can be controlled (thereby enabling the precise positioning ofthe stent) by suitably varying the temperature ofthe thermal transfer device, and therefore the stent, during delivery and/or deployment.
  • the temperature ofthe thermal transfer device is maintained below body temperature during delivery ofthe stent and at the beginning of deployment to allow precise positioning, while in the case where the stent is made of a shape memory alloy having a transition temperature such that the stent obtains its expanded diameter state at a temperature greater than body temperature, the temperature ofthe thermal transfer device is increased to the higher temperature after the stent in its collapsed state has been precisely positioned at the desired location whereupon the stent expands to its expanded diameter state.
  • the thermal transfer device is constructed such that the temperature ofthe stent can be controlled quickly, precisely and non-invasively. Specifically, the temperature ofthe stent can be changed quickly since the stent is in local heat transfer relationship with the thermal transfer device.
  • local heat transfer relationship means either the stent contacts the thermal device or the stent and thermal transfer device are sufficiently close, so that heat is transferred between the stent and the thermal transfer device without materially affecting the temperature ofthe surrounding tissue.
  • the stent' s temperature can be controlled relatively precisely since the temperature ofthe stent, which has a low mass, will essentially correspond to the temperature ofthe thermal transfer device, which has a much higher mass. Moreover, no liquid or gas will be infused directly into the vessel during the entire procedure.
  • the thermal transfer device comprises an arrangement itself capable of controlled radial expansion to about the diameter of a stent in its expanded diameter state, and contraction to a collapsed state.
  • This feature in some of its embodiments, is not only advantageous with respect to the initial delivery of a self-expanding stent with an option of performing a balloon angioplasty at the same time, but, additionally, makes the arrangement particularly adapted for repositioning and/or retrieving stents formed of two-way shape memory alloys that have already been deployed in a vessel, such as in the repositioning of a misplaced stent, removal of a stent placed for temporary indications, or the removal of a stent that has completed the delivery of medication or radiation to a particular area.
  • the thermal transfer device is structured and arranged to be initially positioned in the lumen ofthe already deployed stent in a collapsed condition, out of contact or other local heat transfer relationship with the deployed stent, and then expanded into contact, or other local heat transfer relationship, with the stent.
  • the temperature ofthe heat transfer device is adjusted so that the temperature ofthe deployed stent is reduced to that at which the stent obtains a relaxed, flexible state whereupon it separates from the vessel wall.
  • the stent can then be drawn into the catheter assembly and either removed from the body or repositioned using the initial delivery process described above.
  • the thermal transfer device comprises an inflatable and expandable balloon member, formed of fluid impermeable or micro-porous material and the initial delivery of a stent formed of a shape memory alloy can be assisted in the manner of angioplasty by inflating the balloon to forcibly urge the stent against the vessel walls.
  • the catheter assembly includes a
  • the capturing device for releasably coupling the stent to the catheter assembly during deployment, as well as for grasping an already-deployed stent for purposes of retrieval and/or repositioning.
  • the capturing device prevents the stent from being carried away by the bloodstream or from migrating on the catheter, and is also structured and arranged to assist in drawing the stent in its flexible and pliable condition into the catheter assembly for repositioning and retrieval.
  • the thermal transfer device comprises a balloon member connected to a catheter assembly defining a contained chamber having an outer wall, at least a part of which constitutes a thermal transfer material.
  • the arrangement further includes apparatus for circulating a thermal transfer fluid from the proximal end region ofthe catheter assembly into the interior ofthe chamber and for providing an outflow ofthe thermal transfer fluid from the interior ofthe closed chamber to the proximal end region ofthe catheter assembly.
  • the term fluid refers to either a liquid or a gas.
  • the temperature of the circulating thermal transfer fluid is controlled either by heating or cooling means situated at the proximal end ofthe catheter assembly outside ofthe body, or by heating means situated within the chamber ofthe thermal transfer device, such as optic fibers for transmitting a laser beam to heat the fluid circulating within the thermal transfer device, an internal ultrasound probe situated within the thermal transfer device, or a spiral resistance heating wire which will be heated by induction of an electric current by applying the power source or magnetic field from an external source.
  • the surface ofthe balloon can be heated for direct heat transfer to the stent.
  • resistance heating wires may be situated on the outer surface of an expandable balloon, as can a spiral surface wire which can be heated by induction through the application of a power source or magnetic field from an external source, or externally situated optic fibers for transmitting a laser beam along and around the surface ofthe balloon.
  • the stent is in contact with the heat transfer surface during delivery and depending on the transition temperature ofthe alloy from which the stent is made, the stent is either cooled, heated, or left at ambient temperature through contact or other local heat transfer relationship.
  • the balloon in its collapsed condition is situated in the lumen ofthe already deployed stent, and then expanded into contact with the stent. Cooling liquid is circulated through the balloon which cools the stent causing it to separate from the vessel wall and to become flexible and pliable so that it can be drawn into the catheter assembly.
  • the thermal transfer device comprises an expandable frame formed from a plurality of conductive resistance wires.
  • the frame can be
  • the wires are heated by connection to an external source of electricity and are in direct contact heat transfer relationship with the stent.
  • FIG. 1 is a perspective view of a first embodiment of a catheter assembly, including a first version of a hook-type stent capturing device, and an associated sleeve-type thermal
  • FIG. 2 is a perspective view ofthe first embodiment with the thermal transfer device in a collapsed condition
  • FIG. 3 is a perspective view ofthe first embodiment, partially broken away to show the hook-type stent capturing device ofthe catheter assembly for use in accordance with the
  • FIG. 4 is a perspective view of a first version of a second embodiment of a catheter assembly and associated solid thermal transfer device in an expanded condition for use in accordance with the invention, with a first version of an arrangement for circulating thermal transfer fluid through the thermal transfer device, and a hook-type stent capturing device;
  • FIG. 5 is a perspective view of a first version ofthe second embodiment, partially broken away to show the first version ofthe circulation arrangement;
  • FIG. 5 a is a section view taken along line A-A of FIG. 5;
  • FIG. 5b is a section view taken along line B-B of FIG 5;
  • FIG. 6 is a transverse section view ofthe embodiment of FIG. 5 through the stent-receiving sheath;
  • FIG. 7 is a perspective view ofthe second embodiment with the thermal transfer device in a collapsed condition
  • FIG. 8 is a perspective view of a second version ofthe second embodiment, with a second version ofthe thermal transfer fluid circulating arrangement
  • FIG. 8a is perspective view of another version ofthe second embodiment, with a second version of a stent-capturing device
  • FIG. 8b is a perspective view of still another version ofthe second embodiment, with a third version of a stent-capturing device;
  • FIG. 8c is a perspective view of yet another version ofthe second embodiment which does not utilize a frame assembly
  • FIG. 8d is a perspective view of another version ofthe second embodiment with the second version ofthe thermal transfer fluid circulation arrangement, which incorporates an accordian-like balloon construction shown in its expanded condition.
  • FIG. 8e is a perspective view showing the embodiment of FIG. 8d in a collapsed condition
  • FIG. 9 is a perspective view ofthe second version ofthe second embodiment, partially broken away to show the second version ofthe circulation arrangement
  • FIG. 9a is a section view taken along line A-A of FIG. 9;
  • FIG. 9b is a section view taken along line B-B of FIG. 9;
  • FIG. 9c is a perspective view of a modification ofthe second version ofthe second embodiment, but partially broken away to show the modification ofthe second version ofthe circulation arrangement;
  • FIG. 9d is a section view taken along line D-D of FIG. 9c;
  • FIG. 9e is a section view taken along line E-E of FIG. 9c;
  • FIG. 10 is a perspective view ofthe second version ofthe second embodiment, with the thermal transfer device shown in a collapsed condition;
  • FIGS. 1 l(a)-l 1(g) are seven perspective views showing sequential steps of operation ofthe first and second versions ofthe second embodiment ofthe invention in connection with the deployment ofthe stent;
  • FIG. 1 lh shows two partial perspective views showing the sequence of withdrawal of the stent-receiving sheath from the conus
  • FIGS. 12(a)- 12(1) are twelve perspective views showing sequential steps of operation ofthe first and second versions ofthe second embodiment ofthe invention in connection with repositioning and/or retrieving an already positioned stent;
  • FIGS. 12(m)-(p) are perspective views showing the use of a stent-covering sleeve in
  • FIGS. 12(q) and 12(r) are perspective views ofthe second version ofthe second embodiment ofthe invention utilizing another version of a stent-capturing device specifically designed for use in repositioning the stent;
  • FIG. 13 is a perspective view of a first version of a third embodiment of a catheter assembly, including another version of a stent capturing device, and associated sectored thermal transfer device in its expanded position for use in accordance with the invention, with the first version of a thermal transfer fluid circulation arrangement;
  • FIG. 14 is a perspective view ofthe first version ofthe third embodiment, partially broken away to show the first version ofthe circulation arrangement
  • FIG. 14a is a section view taken along line A-A- FIG. 14;
  • FIG. 14b is a section view taken along line B-B of FIG. 14;
  • FIG. 15 is a longitudinal sectional view ofthe first version ofthe third embodiment
  • FIGS. 16a-c are three perspective views showing sequential steps ofthe collapse of the first version ofthe third embodiment ofthe thermal transfer device from its expanded diameter condition;
  • FIG. 17 is a perspective view ofthe second version ofthe third embodiment ofthe invention, with the second version ofthe thermal transfer fluid circulation arrangement;
  • FIG. 18 is a perspective view ofthe second version ofthe third embodiment, partially broken away to show the second version ofthe circulation arrangement.
  • FIG. 18a is a section view taken along line A-A of FIG. 18;
  • FIG. 18b is a section view taken along line B-B of FIG. 18;
  • FIG. 19 is a longitudinal section view of the second version ofthe third embodiment.
  • FIGS. 20a-20c are three perspective views showing sequential steps ofthe collapse of the second version ofthe third embodiment ofthe thermal transfer device from its expanded diameter condition;
  • FIG. 20d is a perspective view of a modification ofthe second version ofthe third embodiment, partially broken away to show the modification ofthe second version ofthe circulation arrangement;
  • FIGS. 20e and 20f are section views of a modification ofthe second version ofthe third embodiment taken along lines E-E and F-F respectively in FIG. 20d;
  • FIGS. 21a-21f are six perspective views showing sequential steps ofthe operation of the second version ofthe third embodiment ofthe invention in connection with deploying a stent, and also illustrating the corresponding operation ofthe catheter assembly at its
  • FIGS. 22a-22g are seven perspective views showing sequential steps ofthe operation ofthe second version ofthe third embodiment ofthe invention in connection with retrieving the stent, and also illustrating the corresponding operation ofthe catheter assembly at its proximal end;
  • FIG. 23 is a perspective view ofthe first embodiment for use in the invention with the thermal transfer device in a collapsed condition and including a snare-type stent capturing device;
  • FIG. 24a is an elevation view of the entire third embodiment of the catheter assembly and associated sectored thermal transfer device
  • FIG. 24b is a perspective view ofthe third embodiment ofthe invention with a stent
  • FIG. 25 is a perspective view ofthe proximal end ofthe catheter assembly ofthe first version ofthe third embodiment ofthe invention.
  • FIG. 26 is a perspective view ofthe proximal end ofthe catheter assembly ofthe second version ofthe third embodiment ofthe invention.
  • FIG. 27 is a perspective view of a fourth embodiment ofthe catheter assembly and associated thermal transfer device for use in accordance with the invention.
  • FIG. 28 is a perspective view of a fifth embodiment of a catheter assembly and associated thermal transfer device for use in accordance with the invention.
  • FIG. 29 is a perspective view of a sixth embodiment of a catheter assembly and associated thermal transfer device for use in accordance with the invention.
  • FIG. 30 is a perspective view of a seventh embodiment of a catheter assembly and associated thermal transfer device for use in accordance with the invention.
  • FIG. 31 is a perspective view of an eighth embodiment of a catheter assembly and associated thermal transfer device for use in accordance with the invention.
  • FIG. 32 is a perspective view of a ninth embodiment of a catheter assembly and associated thermal transfer device for use in accordance with the invention.
  • Fig.33 is perspective view of a modified second embodiment of a catheter assembly with a balloon made of a microporous material, allowing diffusion of a thermal fluid to the
  • Fig.34 is a perspective view of a second version ofthe second embodiment of a balloon assembly with the first version ofthe thermal fluid circulation arrangement.
  • the stent may be formed of a shape memory material having either a one-way shape memory or a two-way shape memory.
  • the stent must be formed of a two-way shape memory alloy.
  • the stent to be delivered, retrieved and/or repositioned is formed of a two-way shape memory material having or trained to have a second cold memory.
  • the stent expands and recovers its previously imprinted intended functional shape at or below body temperature.
  • the stent In a fully expanded state within the human body, the stent is capable of exerting considerable radial force on the surrounding structures, which allows mechanical opening ofthe vessel lumen and maintaining its long-term patency for free passage of flow.
  • the fully expanded stent When the fully expanded stent is cooled to a temperature in the range of -10°C to +35°C , it becomes compliant, has a reduced stress state, and can be compressed into a reduced diameter, small enough to fit within a low profile delivery system for percutaneous insertion.
  • the stent is constructed of a single continuous thermal shape memory wire, can be cut with laser technology, or formed with a photoetching technique from thermal shape memory tubing to create a mesh-like configuration.
  • the expansive force and the stiffness along the length ofthe stent can be modulated by changes in the dimensions ofthe cell geometry. There are no open or sharp edges at either end ofthe device. This prevents injury to the wall while improving the ability to position, reposition or retrieve the device. Because the wire never overlaps itself, the stent wall thickness is never greater than the wire diameter and both surfaces are smooth.
  • the cells ofthe stent create an open mesh, which is favorable for maintaining the patency of side branches, and also minimizes the length changes, which occur between the collapsed and expanded forms ofthe device.
  • an intraluminal medical device may include a permanent or temporary implantable stent or stent-graft, a permanent or temporary device impregnated with medications or radioactivity for local therapy, or a temporary retrievable/repositionable device.
  • the stent can be covered w th a graft material or coating.
  • the graft material is anchored at each end to an exposed section ofthe metallic scaffold ofthe stent.
  • the design ofthe device is such that length changes that occur during delivery can be largely limited to the short uncovered stent segments at either end ofthe device.
  • the stents can also be impregnated with certain medications or provided with a radioactive coating, for local delivery of drugs or radiation to the diseased vessel.
  • a first embodiment of apparatus in accordance with the invention comprises a catheter assembly 50 A (only the distal end region of which is shown), a thermal transfer device 60A connected to catheter assembly 50A and an associated stent capturing device 70A.
  • Catheter assembly 50A comprises a low profile outer core catheter 8, having an inner movable core catheter 3, an inner stent-capturing sheath 19 situated over the outer core catheter 8, and an outer stent-receiving sheath 11.
  • the thermal transfer device 60A comprises a frame assembly 62 to which an expandable balloon 4 is connected.
  • Balloon 4 has a sleeve-type configuration, i.e., the balloon 4 has an annular cross-section along its entire length. As discussed below, this shape is advantageous since the flow of blood or other body
  • the balloon is formed of material having suitable thermal transfer characteristics, i.e. relatively good heat conductivity.
  • the frame assembly 62 includes a plurality of scaffolding wires 5, each wire 5 having a distal end molded into a conus 2, which has a tapered configuration for easy percutaneous insertion, and a proximal end 9 molded into the outer core catheter 8.
  • the scaffolding wires are preferably formed of a material that exhibits superelastic properties.
  • the outer core catheter 8 has a distal end which is situated proximally to the distal end ofthe inner core catheter 3 so that a projecting portion ofthe inner core catheter 3 extends beyond the distal end ofthe outer core catheter 8.
  • Each ofthe scaffolding wires has one end fixed to the distal end ofthe projecting portion ofthe inner core catheter 3 at conus 2, another end fixed to the distal end ofthe outer core catheter 8, and a central region attached to the
  • the frame assembly can be formed in other manners, such as by the use of elongate plastic members similarly affixed to the inner and outer core catheters.
  • the sleeve-type balloon 4 is formed of a thin elastic sheet material ofthe type used for
  • the balloon In expanded condition the balloon has an outer cylindrical wall 4a, an inner cylindrical wall 4b, and top and bottom walls 4c and 4d, together defining an interior chamber.
  • the central regions of each ofthe six scaffolding wires 5 pass through narrow passages 5a formed in the outer surface ofthe outer wall 4a of balloon 4, to couple the frame assembly 62 to the balloon 4 as seen i FIG. 1 and as noted above, the frame 5 can be stretched and collapsed by advancing the movable inner core 3 forward while the outer core catheter 8 is fixed thereby radially collapsing balloon 4.
  • the inner core catheter 3 has inflow and outflow fluid channels, formed in its wall extending from the proximal end ofthe catheter assembly to the distal end thereof. Inflow and outflow channels are fluidly connected at their distal ends to the interior chamber of balloon 4 by connecting inflow and outflow tubes 7 and 6 respectively.
  • infusion apparatus (not shown) is situated at the proximal end ofthe catheter assembly for circulating a thermal transfer fluid, such as a cold or hot saline liquid or gas (i.e. a fluid) at a temperature sufficient to achieve the transition temperature ofthe stent, into the chamber of balloon 4 through inflow fluid channel and inflow tube 7 to fill the chamber, and then out from the balloon chamber through outflow tube 6 and outflow fluid channel.
  • a thermal transfer fluid such as a cold or hot saline liquid or gas (i.e. a fluid) at a temperature sufficient to achieve the transition temperature ofthe stent
  • a thermal transfer fluid such as a cold or hot saline liquid or gas (i.e. a fluid) at a temperature sufficient to achieve the transition temperature ofthe stent
  • the inflow channel can be connected to a pressurized canister filled with a gas or liquid, hereinafter referred to as a thermal fluid, at a suitable temperature.
  • a thermal fluid can also be injected by a syringe or by means of a pressure bag. Thermal fluid fills the balloon chamber and before this liquid or gas warms up inside the balloon, escapes into the outflow chamiel through outflow tube 6 and then to outside the patient at the other end ofthe system, where it may be collected in a bag (see FIG. 24a). This allows persistent local maintenance of a desired temperature ofthe outer wall 4a of balloon 4 which constitutes a thermal transfer wall ofthe thermal transfer device .
  • the stent-capturing device 70 A comprises a plurality of resilient stent-capturing hooks 17 having hook portions 17a and shank portions 17b, molded into the wall ofthe stent capturing sheath 19 moveably situated over the outer core catheter 8.
  • the hook portions 17A are normally spring biased outwardly to the positions shown in FIG. 1.
  • the resilient portions ofthe hooks 17 can be at least partially covered with a thin membrane 95 to facilitate safe and accurate capturing and holding ofthe stents as described below.
  • stent-receiving sheath 11 in its retracted position as seen in Figs. 1 and 2 has a flared end region 10.
  • the hooks 17 can be opened or closed, i.e., the hook portions 17a moved radially outwardly or inwardly during deployment, retrieval or repositioning of an already deployed stent by advancing or withdrawing, respectively, the stent-receiving sheath 11 whereby the hook portions 17a are controllably engaged by the flared end region 10.
  • the end region ofthe stent-receiving sheath 19 is in a closed condition in sealing engagement within a groove 2a formed in the conus 2.
  • the tip assumes its flared configuration for facilitating the reception and subsequent removal ofthe collapsed stent (FIG. 1 lh).
  • the system is introduced into the body with the frame assembly 62 and balloon 4 of thermal transfer device 60 A in their collapsed condition and covered by the stent-receiving sheath 11.
  • the inner core catheter 3 has a central lumen for receiving a guidewire 1 and two radiopaque markers 15 are provided on the moveable inner core catheter for precise positioning and operation under fluoroscopic guidance.
  • FIG. 4-7 A first version of a second embodiment ofthe invention is illustrated in Figs. 4-7.
  • This embodiment is similar to the embodiment of Figs. 1-3 in that it includes a catheter assembly 50B, a thermal transfer device 60B and a stent-capturing device 70B operationally connected thereto.
  • the second embodiment differs from the first embodiment mainly in that the thermal transfer device 60B comprises a solid-type balloon 12 rather than the sleeve-type balloon 4 ofthe first embodiment.
  • the thermal transfer device 60B comprises a solid-type balloon 12 rather than the sleeve-type balloon 4 ofthe first embodiment.
  • a transverse cross-section ofthe sleeve-type balloon 4 is an annulus
  • the solid balloon has a circular disk-shaped transverse cross-section.
  • the distal end of balloon 12 is sealingly connected to the introducing conus 2 or to the distal end ofthe inner core catheter 3, while the proximal end of balloon 12 is sealed to the more proximal aspect ofthe inner core catheter at 18 thereby defining a chamber.
  • the balloon 12 is made ofthe same type of material as in the case ofthe first embodiment.
  • the thermal transfer device also includes a frame assembly 62A comprising a plurality of scaffolding wires 5, the distal ends of which are molded in the conus 2 fixed to the distal end ofthe inner core catheter 3, the proximal ends of which are molded to the outer core catheter 8, and central regions of which extend through passages 5a formed in the outer surface ofthe balloon 12.
  • the second embodiment ofthe invention shown in Figs. 4-7 also incorporates apparatus for circulating a thermal transfer fluid into and from the interior chamber of balloon
  • channels 13 and 14 are provided in the inner core 3.
  • Channels 13 and 14 extend from the proximal end ofthe inner core catheter 3 and open at respective ports 13a and 14a situated within the chamber of balloon 12.
  • Channel 14 is used for infusion of a thermal fluid into the chamber of balloon 12 while channel 13 is used as an outflow channel.
  • a constant circulation ofthe thermal transfer fluid through the balloon 12 is achieved.
  • the thermal fluid can recirculate through a closed circuit pump system.
  • Inflow channel 14 and outflow channel 13 can be interchanged so that channel 14 is used for outflow while channel 13 is used for inflow.
  • the thermal transfer device 60B can be collapsed in the same manner as thermal transfer device 60A by advancing the moveable core catheter 3 forwardly while holding the outer core 8 fixed.
  • the thermal transfer device 60B can be collapsed by fixing the inner core catheter 3 in place and withdrawing the outer core catheter 8.
  • the stent-capturing device 70B essentially corresponds to the stent-capturing device 70A.
  • a second version ofthe second (solid balloon) embodiment is illustrated in Figs. 8, 9 and 10.
  • This version essentially differs from the first version ofthe second embodiment in the construction ofthe thermal transfer fluid circulation system.
  • the proximal end of balloon 12 is sealingly attached to the outer core catheter 8 at 18a and the space between the outer core catheter 8 and the inner movable core catheter 3 functions as an inflow channel for thermal fluid 25 which opens into the chamber defined by balloon 12.
  • An outflow chaimel 13 is formed in inner core catheter 3 which terminates at a port 13a communicating with the balloon chamber. In this manner, one ofthe two channels in the inner core catheter 3 required in the first version ofthe second embodiment can be eliminated.
  • FIG. 8a A modification of the second version of the second embodiment is shown in FIG. 8a.
  • the capturing wires 96 stay open and do not follow the collapsing balloon until the angled portion ofthe capturing wires become engaged with the bridging bars 98, which will facilitate closing of the capturing wires over the balloon.
  • FIG. 8b demonstrates another modification ofthe second version ofthe second embodiment.
  • the balloon and frame are similar to the second version ofthe second embodiment, but the stent-capturing mechanism consists of four capturing wires 96 which are molded to the inner core catheter at the base ofthe conus 2.
  • the capturing wires 96 extend parallel to the frame wires 5, but outside the balloon 12 and pass through the rings 97 attached to the central portions ofthe frame wires 5.
  • the mechanism of opening and closing ofthe capturing wires 96 is similar to the one described in FIG. 8 a with the only difference being that the capturing wires 96 pass through the rings 97 on the frame instead of extending under the bridging bars 98 between the parallel paired wires in FIG. 8a.
  • FIG. 8c Yet another modification ofthe second version ofthe second embodiment is illustrated in FIG. 8c, where the solid type balloon does not have any metallic frame, but has an inflow channel 25 and an outflow channel 13, and can be expanded and collapsed by relative motion ofthe inner movable core 3 along the outer core catheter 8 in conjunction with injection ofthe thermal fluid under pressure.
  • the embodiment shown in Figs. 8d and 8e is similar to the embodiment shown in Fig. 8c in that it incorporates a frameless balloon 12 that is expanded to the condition shown in FIG. 8d, and collapsed to the condition shown in FIG. 8e, through the relative motion ofthe inner movable core catheter within the outer core catheter in conjunction with controlling the circulation ofthe thermal transfer fluid.
  • the stent capturing device e.g. hooks 17, which may be ofthe type shown in FIG. 8c.
  • the embodiment of FIG. 8d includes a balloon 12 formed with an accordion-like wall construction.
  • the balloon 12 of the embodiment of FIG. 8d is formed with a wall 5 having a pleated or folded configuration.
  • An accordion-like constraction ofthe balloon reduces the stretching force required to collapse the balloon to the condition shown in Fig. 8e.
  • This stretching force is generally large in the case where the balloon is formed of a minimally stretchable polymer material, such as PET.
  • An accordion-like balloon structure therefore provides the flexibility of utilizing a wide range of materials for the balloon including stretchable polymers, such as polyurethanes, as well as minimally elastic polymers, such as PET. Additionally, the accordian-like structure increases the total thermal transfer area ofthe balloon.
  • this type balloon can be provided with a frame for secure holding, capturing and repositioning/retrieval ofthe stents, similar to Fig. 8a and 8b. Other stent-capturing devices may be utilized.
  • the thermal transfer device 60B comprises a balloon 12 having an outer wall 12a and an inner wall 40 attached to the inner surface ofthe outer wall 12a ofthe balloon at equally spaced locations, preferably at the wire sleeves 5 a receiving the frame wires 5, as best seen in Fig 9d.
  • the inner wall 40 and outer wall 12a ofthe balloon define an outer chamber 42 between them while the inner wall 40 defines an inner chamber 44.
  • the inflow of a thermal fluid into the outer chamber 42 is provided through channel 32.
  • the thermal fluid escapes into the inner chamber 44 ofthe balloon after being transiently trapped between the inner and outer layers ofthe balloon for more efficient thermal fransfer through the outer balloon wall 12a.
  • the thermal fluid then escapes into the space between the outer core catheter 8 and the movable core catlieter 33 and is collected into an attached bag at the proximal end ofthe catheter assembly outside the patient. All other components ofthe system and mechanisms of its delivery/retrieval and operation remain the
  • the systems comprising the sleeve type balloon (FIGS. 1-3) and the solid type balloons (FIGS. 4-10), provided with the stent-capturing hooks 17, are beneficial for primary delivery, repositioning or removal of stents including stent-graft devices or covered/coated
  • a clinical scenario of primary stent delivery and deployment into a focal narrowing 80a of a vessel 80 is shown in stages.
  • the stent is formed in accordance with the method ofthe invention of either a one-way or two-way shape memory alloy having a first transition temperature at or below the body temperature.
  • a stent is initially mounted on the thermal transfer
  • the system is provided to the operator in a closed configuration (seen in FIG.1 lb) in which the stent-receiving sheath 11 is in a forward position covering the collapsed stent 90, which has already been preloaded or mounted (such as by crimping) in contacting engagement over the collapsed balloon 12 and with the stent capturing hooks 17 secured to it.
  • the closed configuration the distal end 11a ofthe stent-receiving sheath 11 is received in a groove 2a of conus 2 to seal the space within sheath 11 from the entry of blood or other body fluids in vessel 80 during delivery.
  • the system is introduced into the vessel and positioned under direct fluoroscopic guidance (with the assistance of positioning markers 15) such that the position l ib ofthe delivery system with the premounted stent 90 is situated in the area of narrowing 80a of vessel 80 (FIG.1 lb).
  • the stent-receiving sheath 11 at least partially thermally insulates the collapsed stent 90 from body heat thereby maintaining the temperature ofthe stent 90 below body temperature.
  • deployment of stent 90 begins when the operator retracts or withdraws the stent-receiving sheath 11 exposing the collapsed stent 90 mounted on the collapsed balloon 12 to the vessel interior and to body heat (see FIG. 24b).
  • a cold liquid or gas through the chamber of balloon 12 is started at about the same time as the sheath 11 is withdrawn.
  • a cool saline solution is infused from the proximal end ofthe catheter assembly 50A through inflow channel 14 into the balloon chamber through port 14a and recirculates back through port 13a and outflow channel 13.
  • the temperature ofthe stent 90 is thereby maintained below the transition temperature preventing premature expansion ofthe stent by the local transfer of thermal energy through the wall of the balloon 12 into the thermal transfer fluid.
  • the balloon 12 remains in its collapsed position at this time by maintaining the outflow channel 13 open.
  • a precise positioning of stent 90 is enabled by controlling the expansion of stent 90 through the circulation of cooling thermal fluid even after the sheath 11 is retracted and the stent is exposed to body temperature.
  • the stent-capturing hooks 17 are
  • stent 90 opened and discomiected from stent 90 by further withdrawing ofthe stent-receiving sheath 11 with respect to the stent-capturing sheath 19, and the infusion ofthe cooling thermal fluid is stopped.
  • the opened hooks are withdrawn toward the stent- receiving sheath before the stent expands to avoid interference with the stent as it expands.
  • the stent 90 then warms naturally to body temperature through contact with surrounding blood or other body fluids or gas, and expands towards its original predetermined shape (FIG.1 Id). The stent is thus deployed into supporting engagement with the wall of vessel 80 and exerts an outward force against the wall to open the focal narrowing 80a of vessel 80.
  • Balloon angioplasty ofthe deployed stent can then be performed if clinically indicated. This can be achieved by closing the outflow channel 13 with a provided stop-cock.
  • the balloon is expanded by expansion ofthe frame assembly 62 and infusion of a contrast material diluted in normal saline through the infusion port 14a, which allows visualization of the balloon under real time radiological control (FIG.l le).
  • Opening the frame assembly 62 is achieved by moving the outer core catheter 8 forward relative to inner core catheter 3 which helps expansion ofthe balloon 12.
  • High pressure can be achieved inside the balloon 12, which is regulated and controlled by a pressure manometer connected to the inflow channel outside the patient.
  • Angioplasty (FIG.l le) can be performed sequentially several times if so desired clinically.
  • the balloon 12 is then deflated by opening the outflow channel 13 and the frame
  • this system can be used for deployment of stents exhibiting one-way or two-way memory.
  • stents which are formed of shape-memory alloys that have a transition temperature greater than body temperature and which therefore expand to their predetermined configurations at temperatures higher than body temperature.
  • a stent is delivered in the area of interest in the collapsed state covered with the outer sheath 11 and then exposed by moving the sheath 11 backwards. No infusion of cold thermal transfer fluid is needed to keep the stent in its collapsed state since the temperature ofthe stent will only rise to body temperature which is below the transition temperature.
  • the stent therefore remains mounted on the collapsed balloon 12 secured to the catlieter assembly by stent-capturing hooks.
  • the device is adjusted and the desired location ofthe stent is confirmed, the stent-capturing hooks 17 are opened by further withdrawing ofthe stent-receiving sheath 11, releasing the stent 90 and the infusion of a warm solution at least at the transition temperature which is
  • the frame assembly 62 is opened by moving the outer core catheter 8 forward. These maneuvers allow expansion ofthe mounted stent inside the area of stenosis providing high radial force on the walls ofthe vessel due to its heating to the transformation or transition temperature. If clinically indicated a primary stent placement can be supplemented with a balloon angioplasty with the help of the same delivery system. This can be achieved by closing the outflow channel and infusion of a diluted contrast material through the inflow channel in the manner described above.
  • the stent 90 is formed of a two-way shape memory alloy.
  • the alloy may have a first transition temperature equal to or below body temperature, and a second lower transition temperature in the range of between -10°C to +35°C.
  • the system is introduced with the balloon 12 in a collapsed state and covered with the stent-receiving outer sheath 11 (FIG.12b) and positioned at the desired location such that the collapsed balloon 12 is situated within the lumen of stent 90 that is intended to be retrieved or repositioned.
  • the outer sheath 11 is withdrawn, the distal end 11a obtaining a flared configuration, thereby exposing the frame assembly 62A and the collapsed balloon 12 (FIG.12c).
  • the metallic frame assembly is opened and the outer core catheter 8 advanced while the movable inner core catheter 3 is fixed in place (FIG.12d).
  • Expansion of the frame assembly 62A brings the outer wall of balloon 12 into close contact with the stent.
  • the infusion of a cold thermal fluid into the chamber of balloon 12 is started through the inflow channel 14 and the balloon 12 is inflated without creating high internal pressure within it due to an open outflow channel 13.
  • the diameter of he open wire frame 62A matches the internal diameter ofthe stent and the cold balloon 12 moves into direct contact with the stent, causing its local cooling to the temperature at or below the second transition temperature, e.g. in the range of -10°C to 35°C, through the thermal transfer wall forming balloon 12.
  • the stent becomes soft and pliable at this temperature and reduces at least somewhat in diameter to separate from the wall of vessel 80.
  • the next step includes slowly stretching the wire frame 62 to a smaller diameter by moving the outer core catheter 8 backwards and keeping the movable core catheter 3 ofthe system in the same position. This maneuver causes a slow collapse ofthe frame assembly (FIG.12e).
  • the infusion of cold thermal transfer fluid continues, but the balloon 12 moves away from the wall ofthe vessel 80 or other tubular structure due to stretching ofthe wire frame.
  • the stent, or its proximal end in the case where the stent is designed to operate as such, begins to collapse inwardly hugging the outer wall of balloon 12 and the frame.
  • the stent-capturing hooks 17 are maneuvered to close over the collapsed proximal end ofthe stent by suitable manipulation ofthe stent-capturing sheath 19 (FIG.12f). This causes secure fixation ofthe softened cooled stent to the catheter assembly.
  • the stent is then drawn into the stent-receiving sheath 11 with a flared tip 11a and infusion ofthe cold solution/gas into the balloon 12 is terminated (FIG.12g). Collapse ofthe proximal end ofthe stent prevents migration ofthe device and slippage over the balloon due to persistent contact ofthe distal two thirds ofthe stent with the vessel wall, even though the entire stent becomes very soft.
  • the stent can be then completely removed from the body or repositioned into the proper location (FIG.12h) while inside the stent-receiving sheath 11. In this latter case, the stent is then unsheathed (FIG.12i), warms to body temperature and then expands into the original shape and diameter after the stent-capturing hooks are released (FIG.12J and FIG.12k). The reposition and retrieval system is then removed from the body and the repositioned stent remains in place (FIG.121).
  • Stent retrieval is beneficial in patients where the indication for primary stent placement is an acute intimal dissection, where the stents are used as the vehicle for local delivery of medications or radioactive substances, or in the situations when repositioning of misplaced stent is required.
  • the catheter assembly may be provided with a sleeve 110 formed, for example, of polymer material, which is advanced over the collapsed stent to cover the stent whereupon the entire system, i.e. the collapsed stent situated over the collapsed balloon, is pulled into the stent-receiving sheath 11.
  • the sleeve 110 enables a smooth retraction ofthe stent and balloon into the sheath avoiding the possibility that the edges ofthe stent may catch on the wall ofthe stent receiving sheath 11.
  • the sleeve 110 is supported by a stiff wire 112 that extends from the proximal end ofthe catheter assembly through the wall of sleeve 110 and which terminates at a circular snare 114
  • the wire 112 is advanced to project the sleeve 110 from the position shown in FIG. 12m to that shown in FIG. 12n where the mouth of sleeve 110 is widened through appropriate manipulation ofthe wire 112 so that the mouth encircles the proximal end ofthe stent, and then to the position shown in FIG. 12o in which the sleeve 110 completely covers the stent and balloon.
  • the entire system is then smoothly pulled into the stent-receiving sheath as shown in FIG. 12p.
  • This technique provides smooth transition and gradual reduction in diameter of a captured stent. It ensures easier retraction ofthe entire system into the relatively low profile receiving sheath, avoiding possible capturing ofthe edges of a bare stent struts at the entry opening ofthe receiving sheath.
  • the stent capturing device 70 comprises several hook members 120 connected to the frame wires 5 at each ofthe distal and proximal ends ofthe balloon.
  • the hooks at the proximal end ofthe balloon extend in the proximal direction while the hooks at the distal end ofthe balloon extend in the distal direction.
  • the catheter assembly is positioned at the location ofthe deployed stent and the frame expanded to bring the outer wall of balloon 12 into close contact with the stent.
  • Cold thermal transfer fluid is infused into the chamber of balloon 12 causing the stent to cool to a temperature at or below the second transition temperature.
  • the hooks 120 capture the stent as seen in FIG. 12q.
  • the balloon and stent, captured by hooks 120 continue to collapse until reaching the condition shown in FIG. 12r. Since the stent is captured by the hooks at both its distal and proximal ends, the stent and balloon need not be withdrawn into the stent receiving sheath but can then be repositioned to the precise desired location in the condition shown in FIG. 12r.
  • the flow of cold thermal fluid is discontinued allowing the stent to warm to body temperature and expand fully after releasing the holding hooks..
  • the diameter ofthe stent can be reduced enough for safe repositioning, but the stent does not have to be collapsed completely because it does not have to be withdrawn into a small profile receiving sheath, like it is done for complete retrieval of the device. It is important to note that the stent can be initially delivered using a standard commercially available, modified or specifically designed delivery system used for the regular self-expanding stents.
  • the same system can be used for retrieval or repositioning of a stent made from two-way shape memory alloy having a first transition temperature greater than body temperature and therefore a stent expanding to its original shape at higher than body temperature.
  • These stents require cooling to a temperature below 37°C in order to exhibit second way memory and partially collapse for safe retrieval, with all other steps similar to the ones described in connection with FIG. 12. If repositioning of such a stent is required after it has been recovered into the outer sheath, the position ofthe closed system is adjusted under direct fluoroscopic guidance. The mounted captured stent is unsheathed and stays in the collapsed state without infusion of a cold solution since the first transition temperature is greater than body temperature.
  • the stent-capturing hooks are opened by completely withdrawing the stent-receiving sheath 11 , releasing the stent.
  • a warm solution is infused into the balloon chamber through the infusion port 14a and the metallic frame 62 is opened by moving the outer core catheter forward along the fixed movable core.
  • the steps of repositioning of such a stent are the same as for the primary delivery ofthe stent with the temperature of transformation, i.e. the transition temperature, higher than body temperature, which is described above and can be supplemented with an angioplasty in the same fashion if so desired clinically.
  • the temperature of transformation i.e. the transition temperature, higher than body temperature
  • the thermal transfer device 60C comprises an inflatable and collapsible balloon 20 formed ofthe same type of material as that from which balloons 4 and 12 are made.
  • the balloon 20 has a cloverleaf configuration in the cross sectional view (FIG.14a).
  • Balloon sectors 20 r 20 4 merge with each other at the proximal and distal ends ofthe balloon (FIG.14 and FIG.15) and in the center of the balloon define radial spaces 20 ⁇ 4 , 20 ⁇ , 20 2 . 3 and 20 3 . 4 between them (FIG.14a).
  • Each of the radial spaces are formed by a pair of opposed radially and axially extending wall members 94 extending between the outer wall of balloon 20 and the inner core catheter 3.
  • the distal end ofthe balloon is attached to the inner core catheter 3 at the attachment ofthe cone 2 and the proximal end ofthe balloon is molded to the more proximal portion ofthe inner core catheter 3 at point 18.
  • the thermal transfer device 60C further includes a frame assembly 62C comprising four pairs of scaffolding wires 21, each wire having one end attached to the introducing conus 2, another end molded into the outer core catheter 8 at point 9 and a central region connected to balloon 20 by extending through passages 5a.
  • the stent-capturing device 70C comprises capturing wire fingers 23 situated in
  • each capturing wire finger 23 will be engaged by the bridging member 22a to automatically close the. capturing wire finger.
  • each capturing wire finger 23 will be engaged by a bridging member 22b to automatically open the capturing wire
  • inflow and outflow channels 14 and 13 are formed in the inner core catheter 3 having inflow and outflow ports 14a and 13 a.
  • FIG. 25 shows the proximal end ofthe system ofthe first version ofthe third embodiment shown in FIGS. 13-16 outside the patient, where the stent receiving sheath 11
  • the outer core catheter 8 has a side port 28 for flushing of heparinized saline to prevent thrombus formation in the space between the stent receiving sheath 11 and the outer core catheter 8.
  • the outer core catheter 8 has a side port 28 for flushing of heparinized saline to prevent thrombus formation between the outer core catheter 8 and the inner movable core catheter 3, which itself has two side ports: one port 29 for inflow of solution/gas into the inflow channel 14 of balloon 20 and the other port 26 for outflow of a solution/gas from the outflow channel 13, which is connected to the bag (not shown).
  • the proximal end ofthe cloverleaf balloon 20 is attached to the outer core catheter 8 at point 18a.
  • a second version ofthe third embodiment ofthe invention is illustrated wherein the space between the outer core catheter 8
  • the movable core catheter 3 is used as an inflow channel 25 for infusion of a thermal solution or gas into the balloon.
  • the movable core 3 has a central lumen for the guidewire 1 and channel 13 for outflow of circulating thermal solution or gas. The rest ofthe design of this system is identical to the system of FIGS. 13-16.
  • FIGS. 20D-F illustrate a modification ofthe system wherein both inflow and outflow channels 25 and 31 are provided through the space defined between the outer core catheter 8 and the movable core catheter 3.
  • the channels are separated by two dividing partitions that
  • FIG. 26 illustrates the proximal end ofthe system shown in FIGS. 17-20 outside the patient, where the stent receiving sheath 11 has a side arm port 28 for flushing of heparinized saline to prevent thrombus formation in the space between the stent receiving sheath 11 and the outer core catheter 8.
  • the outer core catheter 8 has a side arm port 27 for infusion of a thermal fluid into the cloverleaf type balloon.
  • the movable core catheter 3 has an opening of an outflow channel 26 from the balloon and is connected to the collecting bag (not shown). A stop-cock is placed on the outflow channel 26 and is closed in cases of performing a balloon angioplasty.
  • FIG. 21 a clinical scenario of primary stent deployment using the cloverleaf balloon system of FIGS. 17-20 is shown for deploying a stent made of a shape memory allow having a transition temperature at or below body temperature.
  • stent covered with the outer sheath is positioned inside the area of focal narrowing ofthe vessel under fluoroscopic guidance (FIG.21a).
  • the sheath is then withdrawn exposing the collapsed mounted stent and the infusion of a cold solution or gas is started immediately to control expansion ofthe stent (FIG.21b).
  • the collapsed stent is secured with the capturing wires or fingers , which together with the local cooling prevent premature expansion ofthe device.
  • the infusion of a cold thermal fluid is stopped and the metallic frame assembly is expanded by moving forward the outer core catheter along the fixed movable core (FIG.21c).
  • the primary stent deployment can be supplemented with a balloon angioplasty under high pressure, which is achieved by closing the outflow channel 13 and infusion of a diluted contrast material via the inflow channel (FIG.21d).
  • the pressure inside the balloon is regulated by the manometer attached to the inflow port outside the patient.
  • the balloon is then deflated by stopping the infusion ofthe contrast material and opening the outflow channel , as well as collapsing the metallic frame by moving the movable core catheter forward along the fixed outer core catheter (FIG.21e).
  • This maneuver also causes the stent-capturing fingers or wires to slide out ofthe cellular spaces in the stent, releasing the stent from the physical restraint (FIG.21e).
  • the collapsed metallic frame and deflated balloon are then withdrawn back into the sheath and the entire system is removed from the body, leaving the stent in place (FIG.21f).
  • the same system can be used for primary deployment of stents having a temperature of transformation higher than body temperature.
  • stent is mounted on the balloon and delivered into the desired location inside the body covered with an outer sheath. It is then unsheathed, but does not expand until infusion of a warm solution at higher than body temperature is started via the inflow channel.
  • the frame is then opened and the stent expands to its original shape and diameter, which it maintains after discontinuation ofthe infusion of a warm solution.
  • the primary stent deployment can be supplemented with a balloon angioplasty in the same fashion as described above.
  • the frame is then collapsed by moving the movable core forward along the fixed outer catheter, which provides sliding ofthe capturing wires out ofthe stent.
  • the stent stays in place, exhibiting persistent radial force on the walls ofthe vessel or other tubular organ.
  • the delivery system is then safely removed from the body.
  • cloverleaf balloon design are shown.
  • the closed system is introduced and positioned inside the stent, which has to be removed (FIG.22a).
  • the outer sheath is then withdrawn back and assumes a flared configuration after detaching from the introducing conus (FIG.22b).
  • the metallic frame opens by advancing the outer core catheter along the fixed movable core and the cold thermal transfer fluid is infused into the balloon to cool the stent to the desired temperature, which is lower for stents with the first transition temperature at or below body temperature and higher (but still lower than body temperature) for stents with the first transition temperature above body temperature (FIG.22c).
  • the outer core catheter 8 is then moved back wlrier the movable core catheter 3 remains fixed in the same position, stretching the frame and collapsing the balloon.
  • the stent, or at least its proximal end collapses with reduction in diameter ofthe frame 62c, wlender the stent-capturing wires 23 stay open nearly touching the vessel wall (FIG.22d).
  • the stent, or at least its proximal end collapses over the stent capturing wires 23, which protrude through the cells ofthe stent.
  • the stent capturing wires 23 remain open until they meet the cross bars 22 bridging the spaces between the sectors 2 ⁇ ! -20 4 of balloon 20.
  • the above described methods prevent any motion ofthe delivery system during deployment.
  • the entire stent uniformly expands at the same time inside the area of narrowing, exerting radial force on the diseased wall ofthe vessel and restoring the normal lumen and flow.
  • All current self-expanding stents have to be unsheathed gradually, exposing immediately expanding small segments ofthe device at a time. Persistent pulling back ofthe sheath during opening ofthe stent inside the vessel can cause slight forward or backward motion ofthe device, potentially leading to misplacement ofthe stent proximal or distal to the area of interest. This problem is eliminated by the system described above.
  • FIG. 23 another device 70D for capturing the stent is illustrated.
  • the stent As the stent is cooled by the thermal transfer device 60, and partially collapses, it is grabbed on the balloon by a snare loop 30.
  • the loose snare loop 30 is advanced around the partially collapsed stent and then tightens into a smaller loop by sliding the thin catheter over it. This maneuver securely fixes the stent to the framed balloon and promotes further mechanical collapse ofthe stent for easy insertion into the outer sheath 11.
  • the material ofthe balloon can be microporous as shown on Fig.33.
  • the balloon 5 may be formed of any suitable material, such as PET sheet material, in which micropores 200 are formed, such as by a laser. The size and number ofthe micropores
  • a microporous balloon wall allows the cooling fluid to diffuse in very small quantities from inside the chamber to the outer surface ofthe balloon, providing more efficient transfer of temperature to the stent. This diffusion of the cooling fluid will not have any detectable systemic effect, but can promote fast and safe control ofthe stent temperature, regulating the crystal state of shape memory material. It is
  • any ofthe balloons described above can be constructed of microporous material.
  • the balloon 5 is attached to the inner core catheter 3 at the distal end and to the outer catheter 8 at the proximal end, with three channels provided inside the inner core catheter 3, i.e, one for a guide wire 1 and two for circulation ofthe thermal transfer fluid, providing inflow and outflow passages 14a, 13 a.
  • This embodiment can be utilized with any of the frame and stent- capturing arrangements described above.
  • the thermal transfer device may comprise means for directly heating the heat fransfer surface ofthe device.
  • FIG. 27 illustrates a solid balloon system with multiple heating electrical resistance wires 34 provided on the surface ofthe balloon 12 to provide direct heating ofthe stent when
  • the wires 34 are connected to an electrical source outside the patient. This system can be beneficial for the deployment of stents having
  • the outer surface ofthe solid balloon 12 is provided with an electromagnetic coil 48, which is heated by generation of an electrical current from application of an external magnetic field.
  • the electromagnetic balloon can be used for deployment of stents having transition temperatures higher than body temperature by direct heating ofthe stent or by heating fluid injected into the balloon.
  • the same system can be used for retrieval or repositioning ofthe stents with transformation temperatures greater than body temperature by infusing a cooling solution/gas into the balloon.
  • first, second and third embodiments ofthe invention described above utilize thermal transfer fluid which is heated or cooled at the proximal end ofthe catheter assembly outside the body, other techniques for heating the thermal fluid may be employed.
  • FIG. 29 illustrates a solid balloon system with an electromagnetic coil 49 inside the balloon (as opposed to outside the balloon as shown in FIG. 28) to provide heating ofthe fluid in the balloon chamber after application of an external magnetic field. It is applicable for the deployment, repositioning or retrieval ofthe stents with first transformation temperatures higher than body temperature.
  • FIG. 30 illustrates a thermal transfer device provided with multiple optic fibers 47 inside the balloon for heating ofthe circulating fluid by a laser beam, which is connected to a
  • the source generator system on the proximal end outside the patient.
  • the system can be used for the deployment, repositioning or retrieval of stents with first transformation temperatures
  • optic fibers 46 are situated on the outer surface ofthe balloon and can be used for direct heating ofthe mounted stent or for heating of fluid circulating inside the balloon.
  • the system can be used for the deployment, repositioning or retrieval of the stents with transition temperature higher than body temperature.
  • FIG. 32 demonstrates another system with an ultrasound probe 51 inside the balloon, which provides fast heating ofthe circulating fluid for the deployment of stents with transition temperatures higher than body temperature.
  • An ultrasound generator is connected to the system on the proximal end outside the patient.
  • the system can be also used for repositioning or retrieval ofthe same stents by circulation of cooling thermal fluid inside the
  • All currently available and all future stents and stent-grafts made from Nitinol or other materials with shape memory capabilities can be delivered with the above described systems and after training or heat/mechanical treatment can demonstrate second way memory effect, and can be retrieved from the body or repositioned into the desired location by using the systems that are described in this patent.

Abstract

Method and apparatus (70B) for delivery and deploying a stent (90) formed of a shape memory alloy to a desired position in a tubular area of the body (80), and/or for repositioning and/or retrieving a stent (90) formed of a two-way shape memory alloy. An arrangement is provided by which the temperature of the stent (90) is locally adjusted during delivery, repositioning and/or retrieval in a safe and controlled manner by engagement with an expandable and collapsible thermal transfer member situated on a catheter assembly (50B).

Description

METHODS AND APPARATUS FOR DELIVERING, REPOSITIONING AND/OR RETRIEVING SELF-EXPANDING STENTS
FIELD OF THE INVENTION
The present invention generally relates to advanced medical endoluminal devices and methods of minimally invasive treatment of blockages ofthe blood vessels and other tubular organs. More particularly, the present invention relates to methods and apparatus for delivering, repositioning and/or retrieving self-expanding stents for internal reinforcing of diseased tubular structure and/or for local delivery of pharmacological or radioactive agents having a beneficial advantage of reduction of re-stenosis.
BACKGROUND OF THE INVENTION A stent is a generally longitudinal cylindrical device formed of biocompatible material, such as a metal or plastic, which is used in the treatment of stenosis, strictures, or aneurysms in body blood vessels and other tubular body structures, such as the esophagus, bile ducts, urinary tract, intestines or tracheo-bronchial tree. References hereafter to blood vessels and vessels will be understood to refer to all such tubular body structures. A stent is held in a reduced diameter state during its passage through a low profile catheter until delivered to the desired location in the blood vessel, whereupon the stent radially expands to an expanded diameter state in the larger diameter vessel to hold the vessel open. As discussed below, radial expansion ofthe stent may be accomplished by an inflatable balloon attached to a catheter, or the stent may be ofthe self-expanding type that will radially expand
once deployed fiom the end portion of a delivery catheter.
Non-diseased vessels that are stented have a tendency to develop more aggressive intimal hyperplasia than diseased vessels. Intimal hyperplasia is part ofthe endothelialization process by which the stent becomes incorporated into the vessel wall as a result ofthe vessel's reaction to a foreign body, and is characterized by deposition of cell layers covering the stent. It eventually results in formation of a neointima, which coats the stent and buries it completely in the vessel wall.
Endothelialization generally improves patency rates and the more complete the apposition ofthe stent to the vessel wall, the more uniform and optimal is the degree of endothelialization. Of course, a fundamental concern is that the stent be deployed in the correct desired location in the vessel as precisely as possible in the first place. This is important when delivering radiation or medication to a particular location using the stent.
Therefore, firstly, it is important that a stent be deployed in the correct desired position in the blood vessel and, secondly that the stent be as completely apposed to the vessel wall as possible.
Stents fall into one of two categories based on their mechanism of deployment and radial expansion, namely, balloon-expandable stents and self-expanding stents.
Balloon-expandable stents (BES) are mounted in their reduced diameter state on nylon or polyethylene balloons, usually by manual crimping, while others are available pre-mounted. One example of a BES is shown in U.S. patent 4,733,665 to Palmaz. BES rely solely on balloon dilation to attain the desired expanded configuration or state. This enables BES to be deployed in a relatively controlled gradual manner. BES in general have more strength than self-expanding stents and initially resist deformation as well as recoil. BES behave elastically but eventually yield and become irreversibly, i.e. plastically, deformed under external force. Most BES are less flexible than self-expanding stents and are therefore less capable of being delivered through tortuous vessels and, when a BES is deployed in a tortuous vessel, it often straightens the vessel, forcing the vessel to conform to the shape of the stent rather than vice versa. This generally results in portions ofthe stent not being
completely apposed to the vessel wall which in turn affects endothelialization and overall patency rate.
On the other hand, BES can generally be deployed in a relatively precise manner at the correct desired location in the vessel since they can be deployed in a controlled gradual manner by gradually controlling the inflation ofthe balloon. This ability to gradually control the expansion ofthe stent, along with the fact that BES rarely change their position on the balloon during inflation, enable fine adjustments to be made by the operator in the position of the stent within the vessel prior to stent deployment.
Self-expanding stents (SES) are formed of braided stainless steel wire or shape-memory alloy such as nitinol and are generally delivered to desired locations in the body in a reduced diameter state in a low profile catheter while covered by an outer sheath which partially insulates the SES from body temperature and mechanically restrains them.
Nitinol is an alloy comprised of approximately 50% nickel and 50% titanium. Nitinol has properties of superelasticity and shape memory. Superelasticity refers to the enhanced ability of material to be deformed without irreversible change in shape. Shape memory is the ability of a material to regain its shape after deformation at a lower temperature. These physical properties of nitinol allow complex device configurations and high expansion ratios enabling percutaneous delivery through low profile access systems.
Superelasticity and shape memory are based on nitinol' s ability to exist in two distinctly different, reversible crystal phases in its solid state at clinically useful temperatures. The alignment of crystals at the higher temperature is called the austenite (A) phase; the aligmnent of crystals at the lower temperature is called the martensite (M) phase. In between is a temperature interval of gradual transition between the A and M phases. Under external force, the shape of a nitinol device can be greatly deformed without irreversible damage. Depending on the temperature at which this external force is applied, superelastic or shape memory effects prevail. In close vicinity to or above the temperature
defining transition into the full A state, superelasticity results: as soon as the deforming force is released, the device immediately assumes it original shape. When nitinol is deformed at or
below the lower temperature ofthe complete M transition, the shape memory effect can be exploited. The device retains its deformed shape even after the external force is removed as long as the temperature ofthe environment stays below the temperature of transition into A phase. Only during heating does the device resume its original shape.
While the shape memory effect is essentially a one-way type phenomena in which
shape recovery occurs only upon heating the alloy to a temperature defining transition to the full A phase, by subjecting the alloy itself to a biasing force, i.e. an internal stress formed by dislocations introduced by plastic deformation in the alloy, a two-way shape memory can be imparted to the alloy so that cooling the alloy will induce a shape change.
One type of self-expanding stent is constructed of wire formed of a shape-memory alloy, such as nitinol, having a transition temperature of about body temperature, i.e. 37°C. For example, reference is made to U.S. patent 5,746,765 to Kleshinski et al. The one-way transition temperature is the temperature of transformation of a nitinol device from its collapsed state into a fully expanded configuration. The stent is pre-loaded on a low profile catheter by crimping the stent at room temperature (at which it can be plastically deformed) onto the catheter. An outer sheath covers the crimped stent and at least partially thermally insulates the stent as it is delivered to the desired location. Upon reaching the desired location, the sheath is withdrawn and the stent is exposed to body temperature whereupon it is naturally warmed to body temperature and expands to its expanded diameter state in supporting contact with the vessel wall. In a fully expanded state within the human body, the stent is capable of exerting considerable radial force on the surrounding structures, which allows mechanical opening ofthe vessel lumen and maintaining its long-term patentcy for free passage of flow.
If an alloy is used for which shape recovery occurs above body temperature, the SES must be heated after release into the body. If shape recovery occurs below body temperature, the device may be cooled during the delivery to prevent expansion inside the delivery catheter. If shape recovery occurs at body temperature, no heating or cooling is necessary during the delivery and deployment, provided delivery is relatively speedy. If, however, a tortuous iliac anatomy or other interference delays prompt deployment of a nitinol stent with these characteristics, premature warming to body temperature could cause expansion in the delivery sheath, increase friction, and interfere with delivery. In this instance, flushing with a cool solution has been suggested.
SES do not require any special preparation prior to deployment. SES behave elastically throughout their lifetime, and do not become irreversibly deformed. When deployed, the nominal diameter is purposely selected to be greater that the diameter ofthe vessel. Therefore, once deployed, an SES exerts continuous outward force on the vessel as it tries to expand to its original dimensions. The ability of an SES to continuously exert an outward force on the vessel coupled with the greater flexibility of SES, generally results in optimal wall apposition, thereby optimizing endothelialization and improving patency rates. Nitinol self-expanding stents have been designed having good radial and hoop strength.
However, while SES are preferable relative to BES in many applications with respect to achieving optimized endothelialization and increased patency rates, currently available methods for delivering and deploying SES are not entirely satisfactory. It has generally not been possible to deploy SES in the correct desired location in a vessel as precisely as in the case of BES with currently available delivery arrangements for the reason that the temperature ofthe SES rapidly increases to body temperature upon withdrawal ofthe outer sheath and therefore the stent quickly expands into engagement with the vessel wall. Consequently, there is not always enough time to finely adjust the position ofthe SES as it quickly expands, and it is not uncommon for the distal end of an SES, which is exposed to body temperature first, and which therefore expands before the rest ofthe SES, to engage and become attached to the vessel wall in the wrong position and in turn inhibit or prevent further adjustments in the position ofthe SES in the vessel.
Another drawback in conventional methods for delivering and deploying SES, as
compared to BES, is that during deployment while BES are advantageously pressed against the vessel wall with a relatively large outward force by the dilating balloon in the manner of an angioplasty to insure attachment ofthe BES to the vessel wall, SES must rely solely on the outward force exerted by the expanding SES to provide initial attachment. It is common to supplement the SES placement with a subsequent balloon angioplasty, which requires exchange ofthe stent delivery system after completion of stent deployment for a balloon catheter.
Still another drawback in conventional methods for delivering and deploying SES is
the possibility that when delivery is protracted, the SES is exposed to body temperature inside the delivery system. The deployment process can then become more difficult the device may open abruptly after being freed from the system and may jump beyond the target as the SE expands during deployment. BES cannot be repositioned or retrieved after deployment and while arrangements have been proposed for enabling the repositioning and/or retrieval of SES formed of two-way shape memory material, no practical workable arrangement has been developed.
A malpositioned stent often requires an additional stent placement to correct the mistake and acliieve the desired results. The stents will remain in the vessel for the entire life
ofthe patient. In a high percentage of patients, the stent will become the site of recurrent stenosis due to an aggressive neointimal proliferation. These patients require repeated interventions, which often include balloon angioplasty and/or additional stent placement.
The most striking illustration of these problems is seen in cardiac patients. Stents and balloon angioplasty transformed the care of patients with heart disease. Each year, about
700,000 patients in the U.S. undergo angioplasty, in which a balloon is used to clear an obstruction in a coronary artery and a stent is deployed to keep it open. Yet a disturbingly
high 15% to 20% ofthe procedures fail within six months, due to the aggressive neointimal proliferation. These patients will often undergo further major treatments, which might be
repeated several times.
The need to be able to reposition and/or retrieve stents from a vessel also arises from the fact that heart researchers and stent manufacturers are developing a new generation of stents that not only prop open the vessel, but which deliver drags to the site ofthe blockage in an effort to minimize or eliminate neointimal proliferation and keep the vessel open for long periods of time. Studies have shown that stents coated with a drug called rapamycin, essentially eliminates re-stenosis. Other medications, such as nitric oxide and paclitaxel or similar compounds, also have a potential to prevent proliferation of scar tissue by killing such cells. One concern is whether the drugs might work too well, inhibiting not only re-stenosis, but also the necessary growth ofthe thin layer of neointima. As previously described, this thin layer of cells, which grows over the stent, smoothes its surface (similar to a layer of Teflon), so blood cells can flow over it without damaging themselves. A damaged blood cell initiates a chemical cascade, which results in clot formation. Therefore an exposed bare metallic stent carries a risk of inducing thrombus formation within it.
The potential of radioactive stents to prevent re-stenosis is an additional area of active research, since local radiation has been shown to inhibit the growth of neointima and halt the progression of atherosclerotic disease.
One can therefore appreciate the benefit of being able to retrieve a stent used for local drug delivery or radiation treatment, after it has achieved its desired effect. This would eliminate potential risk of thrombus formation at the site ofthe exposed bare stent.
In summary, ideally an optimal stent and associated delivery method should possess and combine all the positive traits mentioned so far in each ofthe stent categories. The stent should be pre-loaded on the delivery apparatus and should not require special preparation. It should be flexible to enhance apposition to the vessel wall. It should provide a controlled gradual deployment without stent migration to ensure deployment ofthe stent in the correct location. Lastly, in case of a malpositioned stent, or stent which is deployed for the purpose of its temporary effect, such as for local drug delivery, the system should have the option of enabling repositioning and/or retrieval ofthe stent.
SES can be preloaded on the delivery apparatus, do not require special preparation and are flexible. However, to date, no satisfactory method or apparatus is available for obtaining a controlled gradual deployment of an SES without stent migration, or for repositioning and/or retrieving a SES. While methods have been suggested in the prior art for
delivering SES to a correct location in a precise manner and for repositioning and retrieving SES formed of two-way shape memory material, these prior art arrangements all have drawbacks and have not been adopted in practice.
A method for delivering, repositioning and/or retrieving an SES formed of a two-way shape memory alloy capable of expansion or collapsing in the radial direction in accordance with changes in temperature is disclosed in U.S. patent 5,037,427 to Harada et al. According to Harada et al., a stent is made of nitinol alloy trained to have two-way shape memory. The stent is in an expanded diameter state at about body temperature and in a reduced diameter state at a temperature below body temperature. In delivering the stent, the stent is mounted in the reduced diameter state at the distal end of a catheter over a portion ofthe catheter having a number of side ports. Cooling water supplied through the catheter flows out from the side ports and is brought into contact with the stent during delivery to maintain the stent below body temperature and therefore in the reduced diameter state. When the SES is positioned at the desired location, the supply ofthe cooling water is stopped and the stent is warmed by the heat ofthe body and expands into supporting engagement with the wall ofthe vessel. The catheter is then withdrawn. In retrieving an already-positioned SES using this system, the distal end portion ofthe catheter is inserted into the expanded stent lumen and a cooling fluid is introduced into the catheter and discharged through the side ports at the distal end region into the vessel whereupon the stent is cooled and purportedly collapses onto the distal end
portion ofthe catheter. The stent is retrieved by withdrawing the catheter. The patent suggests that the position ofthe stent can also be changed using this technique.
U.S. Pat. No. 5,746,765 to Kleshinski, Simon, and Rabkin also discloses a stent made from an alloy with two-way shape memory, which expands inside the vessel due to natural heating to body temperature. The stent is covered with an elastic sleeve. When the metal frame is softened by decreased temperature, the sleeve overcomes its radial force and promotes its further contraction for easier retrieval.
U.S. Pat. No. 6,077,298 to Tu et al. discloses a retractable stent made from a one-way shape-memory alloy, such as nitinol, that can be deployed into the body by means of dilation with a balloon catheter. For the stent retrieval, a radio frequency current within the range of 50 to 2,000 kHz must be applied directly to the stent to provide partial collapse ofthe stent after it is heated to a temperature above 43°C to 90°C.
U.S. Pat. No. 5,961,547 to Razavi, U.S. Pat. No. 5,716,410 to Wang et al., U.S. Pat. No. 5,449,372 to Schwaltz et al. and U.S. Pat. No. 5,411,549 to Peters disclose temporary or retractable stents in the shape of a spiral coil or a double helix. Although these stents are made of different materials, such as metal or plastic, and have differences in the techniques of their deployment (heat-activated, self-expanding or balloon expandable), as well as methods of their retrieval (mechanical straightening vs. softening by increasing temperature vs. latch retraction), all of them have one common feature. The stents are connected with a wire extending outside the patient at all times and when they have to be removed, they are simply retracted back into the catheter with or without prior softening ofthe material.
U.S. Patent No. 5,941,895 to Myler et al. discloses a removable cardiovascular stent with engagement hooks extending perpendicular to the axis ofthe stent into the vessel lumen. The stent retrieval technique requires introduction of an extraction catheter, which is adapted to grasp the engagement hooks ofthe stent with subsequent stent elongation in axial direction' and reduction of its cross-sectional diameter.
U.S. Patent No. 5,833,707 to Mclntyre et al. discloses a stent formed from a thin sheet
of metal that has been wound around itself into a general cylindrical tight roll and expands inside the body by heating to body temperature. This stent is designed for predominant use in the human urethra and is not suitable for cardiovascular applications due to very large metal surface that could be thrombogenic and increased size ofthe delivery system. The stent can be removed from the body with the help of a cannula or pincer grips for grasping the edge of the stent. By rotating the pinched stent, the pincer or cannula causes the stent to telescopically coil into smaller diameter, which can then be retrieved from the urethra.
U.S. Patent No. 5,562,641 to Flomenblit et al. discloses a spiral or cylindrical stent made from alloy with two-way shape memory capabilities. The stent expands inside the body by heating to the temperature of 50°C to 80°C with an electric current, injection of hot fluid, external radio frequency irradiation or use of radio frequency antenna inside the catheter. The stent can be removed from the body after cooling to a temperature, ranging from -10°C to +20°C, at which the stent partially collapses in diameter and can be grasped with a catheter for retrieval.
SUMMARY OF THE INVENTION
Accordingly, it is an object ofthe present invention to provide new and improved methods and apparatus for delivering stents to desired locations in blood vessels and other tubular body structures.
Another object ofthe present invention is to provide new and improved methods and apparatus for delivering self-expanding stents to desired locations in body vessels by which the stent can be deployed in a controlled gradual manner to thereby enhance the accuracy of
positioning.
Still another object ofthe present invention is to provide new and improved methods and apparatus for delivering self-expanding stents to desired locations in body vessels by which the stent can be deployed in a controlled gradual manner safely without infusing a cooling liquid directly into the vessel or otherwise affecting general body temperature or
causing systemic affects.
Yet another object ofthe present invention is to provide new and improved methods and apparatus for delivering self-expanding stents to desired locations in body vessels which eliminate the possibility of migration ofthe stent during deployment.
A further object ofthe present invention is to provide new and improved methods and
apparatus for repositioning and/or retrieving self-expanding stents in and from a body vessel without infusing a cooling or heating liquid directly into the vessel or otherwise affecting general body temperature or causing systemic affects.
A still further object ofthe present invention is to provide new and improved methods and apparatus for repositioning and/or retrieving self-expanding stents which eliminates the possibility of migration ofthe stent during repositioning.
A still further object ofthe present invention is to provide new and improved methods and apparatus for providing supplemental balloon angioplasty after stent deployment with the same system, eliminating the need for exchanging catheters.
Briefly, in accordance with one aspect ofthe present invention, these and other objects are attained by providing a method and apparatus for delivering a self-expanding stent formed of a shape memory alloy to a desired location in a body vessel by placing the stent in a collapsed condition in contact, or in other local heat transfer relationship, with a thermal transfer device coupled to a catheter assembly, and delivering the stent in its collapsed condition to the region ofthe desired location in the body vessel while in contact or other local heat transfer relationship with the thermal transfer device. According to the invention, the temperature ofthe thermal transfer device can be controlled in a safe and non-invasive matter so that the expansion ofthe stent can be controlled (thereby enabling the precise positioning ofthe stent) by suitably varying the temperature ofthe thermal transfer device, and therefore the stent, during delivery and/or deployment.
For example, in the case where the stent is made of a shape memory alloy having a transition temperature such that the stent from which it is formed is in its expanded diameter state at or slightly below body temperature (37°C), the temperature ofthe thermal transfer device is maintained below body temperature during delivery ofthe stent and at the beginning of deployment to allow precise positioning, while in the case where the stent is made of a shape memory alloy having a transition temperature such that the stent obtains its expanded diameter state at a temperature greater than body temperature, the temperature ofthe thermal transfer device is increased to the higher temperature after the stent in its collapsed state has been precisely positioned at the desired location whereupon the stent expands to its expanded diameter state.
The thermal transfer device is constructed such that the temperature ofthe stent can be controlled quickly, precisely and non-invasively. Specifically, the temperature ofthe stent can be changed quickly since the stent is in local heat transfer relationship with the thermal transfer device. For present purposes, local heat transfer relationship means either the stent contacts the thermal device or the stent and thermal transfer device are sufficiently close, so that heat is transferred between the stent and the thermal transfer device without materially affecting the temperature ofthe surrounding tissue. The stent' s temperature can be controlled relatively precisely since the temperature ofthe stent, which has a low mass, will essentially correspond to the temperature ofthe thermal transfer device, which has a much higher mass. Moreover, no liquid or gas will be infused directly into the vessel during the entire procedure. h preferred embodiments ofthe invention, the thermal transfer device comprises an arrangement itself capable of controlled radial expansion to about the diameter of a stent in its expanded diameter state, and contraction to a collapsed state. This feature, in some of its embodiments, is not only advantageous with respect to the initial delivery of a self-expanding stent with an option of performing a balloon angioplasty at the same time, but, additionally, makes the arrangement particularly adapted for repositioning and/or retrieving stents formed of two-way shape memory alloys that have already been deployed in a vessel, such as in the repositioning of a misplaced stent, removal of a stent placed for temporary indications, or the removal of a stent that has completed the delivery of medication or radiation to a particular area. Specifically, for removal and/or repositioning ofthe stent, the thermal transfer device is structured and arranged to be initially positioned in the lumen ofthe already deployed stent in a collapsed condition, out of contact or other local heat transfer relationship with the deployed stent, and then expanded into contact, or other local heat transfer relationship, with the stent. The temperature ofthe heat transfer device is adjusted so that the temperature ofthe deployed stent is reduced to that at which the stent obtains a relaxed, flexible state whereupon it separates from the vessel wall. The stent can then be drawn into the catheter assembly and either removed from the body or repositioned using the initial delivery process described above.
In one embodiment, the thermal transfer device comprises an inflatable and expandable balloon member, formed of fluid impermeable or micro-porous material and the initial delivery of a stent formed of a shape memory alloy can be assisted in the manner of angioplasty by inflating the balloon to forcibly urge the stent against the vessel walls.
In accordance with another aspect ofthe invention, the catheter assembly includes a
capturing device for releasably coupling the stent to the catheter assembly during deployment, as well as for grasping an already-deployed stent for purposes of retrieval and/or repositioning. The capturing device prevents the stent from being carried away by the bloodstream or from migrating on the catheter, and is also structured and arranged to assist in drawing the stent in its flexible and pliable condition into the catheter assembly for repositioning and retrieval.
In a preferred embodiment, the thermal transfer device comprises a balloon member connected to a catheter assembly defining a contained chamber having an outer wall, at least a part of which constitutes a thermal transfer material. The arrangement further includes apparatus for circulating a thermal transfer fluid from the proximal end region ofthe catheter assembly into the interior ofthe chamber and for providing an outflow ofthe thermal transfer fluid from the interior ofthe closed chamber to the proximal end region ofthe catheter assembly. As used herein, the term fluid refers to either a liquid or a gas. The temperature of the circulating thermal transfer fluid is controlled either by heating or cooling means situated at the proximal end ofthe catheter assembly outside ofthe body, or by heating means situated within the chamber ofthe thermal transfer device, such as optic fibers for transmitting a laser beam to heat the fluid circulating within the thermal transfer device, an internal ultrasound probe situated within the thermal transfer device, or a spiral resistance heating wire which will be heated by induction of an electric current by applying the power source or magnetic field from an external source. Alternatively, the surface ofthe balloon can be heated for direct heat transfer to the stent. For example, resistance heating wires may be situated on the outer surface of an expandable balloon, as can a spiral surface wire which can be heated by induction through the application of a power source or magnetic field from an external source, or externally situated optic fibers for transmitting a laser beam along and around the surface ofthe balloon. The stent is in contact with the heat transfer surface during delivery and depending on the transition temperature ofthe alloy from which the stent is made, the stent is either cooled, heated, or left at ambient temperature through contact or other local heat transfer relationship. In capturing an already deployed stent, the balloon in its collapsed condition is situated in the lumen ofthe already deployed stent, and then expanded into contact with the stent. Cooling liquid is circulated through the balloon which cools the stent causing it to separate from the vessel wall and to become flexible and pliable so that it can be drawn into the catheter assembly.
In another preferred embodiment, the thermal transfer device comprises an expandable frame formed from a plurality of conductive resistance wires. The frame can be
expanded by suitable adjustment ofthe catheter assembly to bow the resistance wires radially outwardly into contact with the stent. The wires are heated by connection to an external source of electricity and are in direct contact heat transfer relationship with the stent.
DESCRIPTION OF THE DRAWINGS
A more complete appreciation ofthe present invention and many ofthe attendant advantages thereof will be readily understood by reference to the following detailed description when considered in connection with the accompanying drawings in which:
FIG. 1 is a perspective view of a first embodiment of a catheter assembly, including a first version of a hook-type stent capturing device, and an associated sleeve-type thermal
transfer device in accordance with the invention, with the thermal transfer device shown in expanded condition;
FIG. 2 is a perspective view ofthe first embodiment with the thermal transfer device in a collapsed condition;
FIG. 3 is a perspective view ofthe first embodiment, partially broken away to show the hook-type stent capturing device ofthe catheter assembly for use in accordance with the
invention;
FIG. 4 is a perspective view of a first version of a second embodiment of a catheter assembly and associated solid thermal transfer device in an expanded condition for use in accordance with the invention, with a first version of an arrangement for circulating thermal transfer fluid through the thermal transfer device, and a hook-type stent capturing device; FIG. 5 is a perspective view of a first version ofthe second embodiment, partially broken away to show the first version ofthe circulation arrangement;
FIG. 5 a is a section view taken along line A-A of FIG. 5;
FIG. 5b is a section view taken along line B-B of FIG 5;
FIG. 6 is a transverse section view ofthe embodiment of FIG. 5 through the stent-receiving sheath;
FIG. 7 is a perspective view ofthe second embodiment with the thermal transfer device in a collapsed condition;
FIG. 8 is a perspective view of a second version ofthe second embodiment, with a second version ofthe thermal transfer fluid circulating arrangement;
FIG. 8a is perspective view of another version ofthe second embodiment, with a second version of a stent-capturing device;
FIG. 8b is a perspective view of still another version ofthe second embodiment, with a third version of a stent-capturing device;
FIG. 8c is a perspective view of yet another version ofthe second embodiment which does not utilize a frame assembly;
FIG. 8d is a perspective view of another version ofthe second embodiment with the second version ofthe thermal transfer fluid circulation arrangement, which incorporates an accordian-like balloon construction shown in its expanded condition.
FIG. 8e is a perspective view showing the embodiment of FIG. 8d in a collapsed condition;
FIG. 9 is a perspective view ofthe second version ofthe second embodiment, partially broken away to show the second version ofthe circulation arrangement;
FIG. 9a is a section view taken along line A-A of FIG. 9; FIG. 9b is a section view taken along line B-B of FIG. 9;
FIG. 9c is a perspective view of a modification ofthe second version ofthe second embodiment, but partially broken away to show the modification ofthe second version ofthe circulation arrangement;
FIG. 9d is a section view taken along line D-D of FIG. 9c;
FIG. 9e is a section view taken along line E-E of FIG. 9c;
FIG. 10 is a perspective view ofthe second version ofthe second embodiment, with the thermal transfer device shown in a collapsed condition;
FIGS. 1 l(a)-l 1(g) are seven perspective views showing sequential steps of operation ofthe first and second versions ofthe second embodiment ofthe invention in connection with the deployment ofthe stent;
FIG. 1 lh shows two partial perspective views showing the sequence of withdrawal of the stent-receiving sheath from the conus;
FIGS. 12(a)- 12(1) are twelve perspective views showing sequential steps of operation ofthe first and second versions ofthe second embodiment ofthe invention in connection with repositioning and/or retrieving an already positioned stent;
FIGS. 12(m)-(p) are perspective views showing the use of a stent-covering sleeve in
connection with the retraction of a collapsed stent into a stent-receiving sheath;
FIGS. 12(q) and 12(r) are perspective views ofthe second version ofthe second embodiment ofthe invention utilizing another version of a stent-capturing device specifically designed for use in repositioning the stent;
FIG. 13 is a perspective view of a first version of a third embodiment of a catheter assembly, including another version of a stent capturing device, and associated sectored thermal transfer device in its expanded position for use in accordance with the invention, with the first version of a thermal transfer fluid circulation arrangement;
FIG. 14 is a perspective view ofthe first version ofthe third embodiment, partially broken away to show the first version ofthe circulation arrangement;
FIG. 14a is a section view taken along line A-A- FIG. 14;
FIG. 14b is a section view taken along line B-B of FIG. 14;
FIG. 15 is a longitudinal sectional view ofthe first version ofthe third embodiment;
FIGS. 16a-c are three perspective views showing sequential steps ofthe collapse of the first version ofthe third embodiment ofthe thermal transfer device from its expanded diameter condition;
FIG. 17 is a perspective view ofthe second version ofthe third embodiment ofthe invention, with the second version ofthe thermal transfer fluid circulation arrangement;
FIG. 18 is a perspective view ofthe second version ofthe third embodiment, partially broken away to show the second version ofthe circulation arrangement.
FIG. 18a is a section view taken along line A-A of FIG. 18;
FIG. 18b is a section view taken along line B-B of FIG. 18;
FIG. 19 is a longitudinal section view ofthe second version ofthe third embodiment;
FIGS. 20a-20c are three perspective views showing sequential steps ofthe collapse of the second version ofthe third embodiment ofthe thermal transfer device from its expanded diameter condition;
FIG. 20d is a perspective view of a modification ofthe second version ofthe third embodiment, partially broken away to show the modification ofthe second version ofthe circulation arrangement;
FIGS. 20e and 20f are section views of a modification ofthe second version ofthe third embodiment taken along lines E-E and F-F respectively in FIG. 20d; FIGS. 21a-21f are six perspective views showing sequential steps ofthe operation of the second version ofthe third embodiment ofthe invention in connection with deploying a stent, and also illustrating the corresponding operation ofthe catheter assembly at its
proximal end;
FIGS. 22a-22g are seven perspective views showing sequential steps ofthe operation ofthe second version ofthe third embodiment ofthe invention in connection with retrieving the stent, and also illustrating the corresponding operation ofthe catheter assembly at its proximal end;
FIG. 23 is a perspective view ofthe first embodiment for use in the invention with the thermal transfer device in a collapsed condition and including a snare-type stent capturing device;
FIG. 24a is an elevation view ofthe entire third embodiment ofthe catheter assembly and associated sectored thermal transfer device;
FIG. 24b is a perspective view ofthe third embodiment ofthe invention with a stent
pre-mounted on the collapsed thermal transfer device;
FIG. 25 is a perspective view ofthe proximal end ofthe catheter assembly ofthe first version ofthe third embodiment ofthe invention;
FIG. 26 is a perspective view ofthe proximal end ofthe catheter assembly ofthe second version ofthe third embodiment ofthe invention;
FIG. 27 is a perspective view of a fourth embodiment ofthe catheter assembly and associated thermal transfer device for use in accordance with the invention;
FIG. 28 is a perspective view of a fifth embodiment of a catheter assembly and associated thermal transfer device for use in accordance with the invention;
FIG. 29 is a perspective view of a sixth embodiment of a catheter assembly and associated thermal transfer device for use in accordance with the invention;
FIG. 30 is a perspective view of a seventh embodiment of a catheter assembly and associated thermal transfer device for use in accordance with the invention;
FIG. 31 is a perspective view of an eighth embodiment of a catheter assembly and associated thermal transfer device for use in accordance with the invention;
FIG. 32 is a perspective view of a ninth embodiment of a catheter assembly and associated thermal transfer device for use in accordance with the invention;
Fig.33 is perspective view of a modified second embodiment of a catheter assembly with a balloon made of a microporous material, allowing diffusion of a thermal fluid to the
outer surface ofthe balloon;
Fig.34 is a perspective view of a second version ofthe second embodiment of a balloon assembly with the first version ofthe thermal fluid circulation arrangement.
DESCRIPTION OF THE PREFERRED EMBODIMENTS Various embodiments of apparatus and methods for delivering a self-expanding stent and/or for retrieving and repositioning an already-positioned self-expanding stent in accordance with the invention are described herein. In all cases, where the apparatus is to be used for delivering a stent, the stent may be formed of a shape memory material having either a one-way shape memory or a two-way shape memory. However, in the case where the apparatus is to be used for retrieving and/or repositioning a stent that is already in place, the stent must be formed of a two-way shape memory alloy.
For purposes of describing the invention, except where noted, the stent to be delivered, retrieved and/or repositioned is formed of a two-way shape memory material having or trained to have a second cold memory. When released into the vessel or other tubular structure and naturally warmed to first transition temperature at or below body
temperature of 37°C, the stent expands and recovers its previously imprinted intended functional shape at or below body temperature. In a fully expanded state within the human body, the stent is capable of exerting considerable radial force on the surrounding structures, which allows mechanical opening ofthe vessel lumen and maintaining its long-term patency for free passage of flow. When the fully expanded stent is cooled to a temperature in the range of -10°C to +35°C , it becomes compliant, has a reduced stress state, and can be compressed into a reduced diameter, small enough to fit within a low profile delivery system for percutaneous insertion.
The stent is constructed of a single continuous thermal shape memory wire, can be cut with laser technology, or formed with a photoetching technique from thermal shape memory tubing to create a mesh-like configuration. The expansive force and the stiffness along the length ofthe stent can be modulated by changes in the dimensions ofthe cell geometry. There are no open or sharp edges at either end ofthe device. This prevents injury to the wall while improving the ability to position, reposition or retrieve the device. Because the wire never overlaps itself, the stent wall thickness is never greater than the wire diameter and both surfaces are smooth. The cells ofthe stent create an open mesh, which is favorable for maintaining the patency of side branches, and also minimizes the length changes, which occur between the collapsed and expanded forms ofthe device. The shortening ofthe stent during its expansion depends on the cell geometry, but usually does not exceed 10% ofthe length of the stent in its completely expanded state. In a preferred embodiment, an intraluminal medical device may include a permanent or temporary implantable stent or stent-graft, a permanent or temporary device impregnated with medications or radioactivity for local therapy, or a temporary retrievable/repositionable device. For the purpose of non-surgical treatment of vascular aneurysms, acutely bleeding vessels, or other perforated tubular organs (GI tract, bile ducts, tracheo-bronchial tree etc.), the stent can be covered w th a graft material or coating. The graft material is anchored at each end to an exposed section ofthe metallic scaffold ofthe stent. The design ofthe device is such that length changes that occur during delivery can be largely limited to the short uncovered stent segments at either end ofthe device. The stents can also be impregnated with certain medications or provided with a radioactive coating, for local delivery of drugs or radiation to the diseased vessel.
Referring now to the drawings in which like reference characters designate identical or corresponding parts throughout the several views, and more particularly to Figs. 1-3, a first embodiment of apparatus in accordance with the invention comprises a catheter assembly 50 A (only the distal end region of which is shown), a thermal transfer device 60A connected to catheter assembly 50A and an associated stent capturing device 70A. Catheter assembly 50A comprises a low profile outer core catheter 8, having an inner movable core catheter 3, an inner stent-capturing sheath 19 situated over the outer core catheter 8, and an outer stent-receiving sheath 11. In this embodiment, the thermal transfer device 60A comprises a frame assembly 62 to which an expandable balloon 4 is connected. Balloon 4 has a sleeve-type configuration, i.e., the balloon 4 has an annular cross-section along its entire length. As discussed below, this shape is advantageous since the flow of blood or other body
fluid which normally occurs in the vessel will be maintained during inflation ofthe balloon through the opening 16 in the center ofthe balloon 4. As described below, the balloon is formed of material having suitable thermal transfer characteristics, i.e. relatively good heat conductivity.
The frame assembly 62 includes a plurality of scaffolding wires 5, each wire 5 having a distal end molded into a conus 2, which has a tapered configuration for easy percutaneous insertion, and a proximal end 9 molded into the outer core catheter 8. The scaffolding wires are preferably formed of a material that exhibits superelastic properties.
The outer core catheter 8 has a distal end which is situated proximally to the distal end ofthe inner core catheter 3 so that a projecting portion ofthe inner core catheter 3 extends beyond the distal end ofthe outer core catheter 8. Each ofthe scaffolding wires has one end fixed to the distal end ofthe projecting portion ofthe inner core catheter 3 at conus 2, another end fixed to the distal end ofthe outer core catheter 8, and a central region attached to the
balloon 4.
It will be seen that by relative movement ofthe inner and outer core catheters to shorten the projecting portion ofthe inner core, the wires 5 will bow or bend and therefore expand the balloon to its expanded condition shown in FIG. 1. On the other hand, relative movement ofthe inner and outer core catheters to lengthen the projecting portion ofthe inner core straightens the wires and collapses the balloon to its collapsed condition as seen in FIG. 2. The frame assembly can be formed in other manners, such as by the use of elongate plastic members similarly affixed to the inner and outer core catheters.
The sleeve-type balloon 4 is formed of a thin elastic sheet material ofthe type used for
conventional balloon angioplasty catheters, such as polyethylene or other polymer film for example, having a thickness of about .001 inches, or other thin flexible biocompatible material having thermal transfer properties, sufficient for the present purpose. In expanded condition the balloon has an outer cylindrical wall 4a, an inner cylindrical wall 4b, and top and bottom walls 4c and 4d, together defining an interior chamber. The central regions of each ofthe six scaffolding wires 5 pass through narrow passages 5a formed in the outer surface ofthe outer wall 4a of balloon 4, to couple the frame assembly 62 to the balloon 4 as seen i FIG. 1 and as noted above, the frame 5 can be stretched and collapsed by advancing the movable inner core 3 forward while the outer core catheter 8 is fixed thereby radially collapsing balloon 4.
The inner core catheter 3 has inflow and outflow fluid channels, formed in its wall extending from the proximal end ofthe catheter assembly to the distal end thereof. Inflow and outflow channels are fluidly connected at their distal ends to the interior chamber of balloon 4 by connecting inflow and outflow tubes 7 and 6 respectively. A pump or an
infusion apparatus (not shown) is situated at the proximal end ofthe catheter assembly for circulating a thermal transfer fluid, such as a cold or hot saline liquid or gas (i.e. a fluid) at a temperature sufficient to achieve the transition temperature ofthe stent, into the chamber of balloon 4 through inflow fluid channel and inflow tube 7 to fill the chamber, and then out from the balloon chamber through outflow tube 6 and outflow fluid channel. The term fluid is used herein in its broad sense and comprises both liquids and gases.
Alternatively, the inflow channel can be connected to a pressurized canister filled with a gas or liquid, hereinafter referred to as a thermal fluid, at a suitable temperature. Thermal fluid can also be injected by a syringe or by means of a pressure bag. Thermal fluid fills the balloon chamber and before this liquid or gas warms up inside the balloon, escapes into the outflow chamiel through outflow tube 6 and then to outside the patient at the other end ofthe system, where it may be collected in a bag (see FIG. 24a). This allows persistent local maintenance of a desired temperature ofthe outer wall 4a of balloon 4 which constitutes a thermal transfer wall ofthe thermal transfer device .
As seen in FIGS.1-3, the stent-capturing device 70 A comprises a plurality of resilient stent-capturing hooks 17 having hook portions 17a and shank portions 17b, molded into the wall ofthe stent capturing sheath 19 moveably situated over the outer core catheter 8. The hook portions 17A are normally spring biased outwardly to the positions shown in FIG. 1. The resilient portions ofthe hooks 17 can be at least partially covered with a thin membrane 95 to facilitate safe and accurate capturing and holding ofthe stents as described below. The
stent-receiving sheath 11 in its retracted position as seen in Figs. 1 and 2 has a flared end region 10. The hooks 17 can be opened or closed, i.e., the hook portions 17a moved radially outwardly or inwardly during deployment, retrieval or repositioning of an already deployed stent by advancing or withdrawing, respectively, the stent-receiving sheath 11 whereby the hook portions 17a are controllably engaged by the flared end region 10.
As seen in FIGS. 1 lb and 1 lh, when the catheter assembly is introduced into the body, the end region ofthe stent-receiving sheath 19 is in a closed condition in sealing engagement within a groove 2a formed in the conus 2. When the stent-receiving sheath is withdrawn to expose a preloaded stent or balloon, the tip assumes its flared configuration for facilitating the reception and subsequent removal ofthe collapsed stent (FIG. 1 lh).
As described below in connection with Figs. 11 and 12, the system is introduced into the body with the frame assembly 62 and balloon 4 of thermal transfer device 60 A in their collapsed condition and covered by the stent-receiving sheath 11. As seen in FIGS. 1-3 the inner core catheter 3 has a central lumen for receiving a guidewire 1 and two radiopaque markers 15 are provided on the moveable inner core catheter for precise positioning and operation under fluoroscopic guidance.
A first version of a second embodiment ofthe invention is illustrated in Figs. 4-7. This embodiment is similar to the embodiment of Figs. 1-3 in that it includes a catheter assembly 50B, a thermal transfer device 60B and a stent-capturing device 70B operationally connected thereto. The second embodiment differs from the first embodiment mainly in that the thermal transfer device 60B comprises a solid-type balloon 12 rather than the sleeve-type balloon 4 ofthe first embodiment. In other words, while a transverse cross-section ofthe sleeve-type balloon 4 is an annulus, the solid balloon has a circular disk-shaped transverse cross-section. The distal end of balloon 12 is sealingly connected to the introducing conus 2 or to the distal end ofthe inner core catheter 3, while the proximal end of balloon 12 is sealed to the more proximal aspect ofthe inner core catheter at 18 thereby defining a chamber. The balloon 12 is made ofthe same type of material as in the case ofthe first embodiment. The
central region 12a ofthe balloon constitutes a thermal transfer wall as discussed below. Like the first embodiment, the thermal transfer device also includes a frame assembly 62A comprising a plurality of scaffolding wires 5, the distal ends of which are molded in the conus 2 fixed to the distal end ofthe inner core catheter 3, the proximal ends of which are molded to the outer core catheter 8, and central regions of which extend through passages 5a formed in the outer surface ofthe balloon 12.
The second embodiment ofthe invention shown in Figs. 4-7 also incorporates apparatus for circulating a thermal transfer fluid into and from the interior chamber of balloon
12. While the inner moveable core 3 has a central lumen for the guidewire 1 in the same manner as in the first embodiment, two continuous channels 13 and 14 are provided in the inner core 3. Channels 13 and 14 extend from the proximal end ofthe inner core catheter 3 and open at respective ports 13a and 14a situated within the chamber of balloon 12. Channel 14 is used for infusion of a thermal fluid into the chamber of balloon 12 while channel 13 is used as an outflow channel. By suitably connecting the proximal end of channel 14 to a pump, or other source of infusion of thermal fluid, and by suitably connecting the proximal end of channel 13 to a collecting container, a constant circulation ofthe thermal transfer fluid through the balloon 12 is achieved. Alternatively, the thermal fluid can recirculate through a closed circuit pump system. Inflow channel 14 and outflow channel 13 can be interchanged so that channel 14 is used for outflow while channel 13 is used for inflow.
Referring to FIG. 7, as described below in connection with Figs. 11 and 12, the thermal transfer device 60B can be collapsed in the same manner as thermal transfer device 60A by advancing the moveable core catheter 3 forwardly while holding the outer core 8 fixed. Alternatively, the thermal transfer device 60B can be collapsed by fixing the inner core catheter 3 in place and withdrawing the outer core catheter 8. The stent-capturing device 70B essentially corresponds to the stent-capturing device 70A.
A second version ofthe second (solid balloon) embodiment is illustrated in Figs. 8, 9 and 10. This version essentially differs from the first version ofthe second embodiment in the construction ofthe thermal transfer fluid circulation system. The proximal end of balloon 12 is sealingly attached to the outer core catheter 8 at 18a and the space between the outer core catheter 8 and the inner movable core catheter 3 functions as an inflow channel for thermal fluid 25 which opens into the chamber defined by balloon 12. An outflow chaimel 13 is formed in inner core catheter 3 which terminates at a port 13a communicating with the balloon chamber. In this manner, one ofthe two channels in the inner core catheter 3 required in the first version ofthe second embodiment can be eliminated.
A modification ofthe second version ofthe second embodiment is shown in FIG. 8a,
where the frame wires 5 are paired and interconnected with a single bridging bar 98 in their central portions. The stent-capturing sheath 19 with the capturing hooks are eliminated in this modification. Instead, there are at least four capturing wires 96, which are molded to the inner core catheter 3 at the base of conus 2. The capturing wires 96 extend parallel to the frame wires 5, but outside the balloon 12 and pass under the bridging bars 98 between the central portions ofthe paired frame wires 5. The relative motion ofthe movable core 3 and the outer core catheter 8 promotes opening and closing ofthe capturing wires 96. When the balloon 12 is expanded, capturing wires 96 open with it. When the balloon is slowly deflated, the capturing wires 96 stay open and do not follow the collapsing balloon until the angled portion ofthe capturing wires become engaged with the bridging bars 98, which will facilitate closing of the capturing wires over the balloon.
FIG. 8b demonstrates another modification ofthe second version ofthe second embodiment. The balloon and frame are similar to the second version ofthe second embodiment, but the stent-capturing mechanism consists of four capturing wires 96 which are molded to the inner core catheter at the base ofthe conus 2. The capturing wires 96 extend parallel to the frame wires 5, but outside the balloon 12 and pass through the rings 97 attached to the central portions ofthe frame wires 5. The mechanism of opening and closing ofthe capturing wires 96 is similar to the one described in FIG. 8 a with the only difference being that the capturing wires 96 pass through the rings 97 on the frame instead of extending under the bridging bars 98 between the parallel paired wires in FIG. 8a.
Yet another modification ofthe second version ofthe second embodiment is illustrated in FIG. 8c, where the solid type balloon does not have any metallic frame, but has an inflow channel 25 and an outflow channel 13, and can be expanded and collapsed by relative motion ofthe inner movable core 3 along the outer core catheter 8 in conjunction with injection ofthe thermal fluid under pressure.
The embodiment shown in Figs. 8d and 8e is similar to the embodiment shown in Fig. 8c in that it incorporates a frameless balloon 12 that is expanded to the condition shown in FIG. 8d, and collapsed to the condition shown in FIG. 8e, through the relative motion ofthe inner movable core catheter within the outer core catheter in conjunction with controlling the circulation ofthe thermal transfer fluid. Not shown for purposes of clarity is the stent capturing device, e.g. hooks 17, which may be ofthe type shown in FIG. 8c. Unlike the smooth- walled balloon 12 ofthe embodiment of FIG. 8c, the embodiment of FIG. 8d includes a balloon 12 formed with an accordion-like wall construction. Specifically, the balloon 12 of the embodiment of FIG. 8d is formed with a wall 5 having a pleated or folded configuration.
An accordion-like constraction ofthe balloon reduces the stretching force required to collapse the balloon to the condition shown in Fig. 8e. This stretching force is generally large in the case where the balloon is formed of a minimally stretchable polymer material, such as PET. An accordion-like balloon structure therefore provides the flexibility of utilizing a wide range of materials for the balloon including stretchable polymers, such as polyurethanes, as well as minimally elastic polymers, such as PET. Additionally, the accordian-like structure increases the total thermal transfer area ofthe balloon. Alternatively this type balloon can be provided with a frame for secure holding, capturing and repositioning/retrieval ofthe stents, similar to Fig. 8a and 8b. Other stent-capturing devices may be utilized. The design ofthe accordion- shaped balloon is advantageous since it significantly decreases the forces required to stretch and collapse a balloon. Referring to Figs. 9c-9e, a modification ofthe second solid balloon embodiment ofthe invention is illustrated. In this embodiment, the thermal transfer device 60B comprises a balloon 12 having an outer wall 12a and an inner wall 40 attached to the inner surface ofthe outer wall 12a ofthe balloon at equally spaced locations, preferably at the wire sleeves 5 a receiving the frame wires 5, as best seen in Fig 9d. The inner wall 40 and outer wall 12a ofthe balloon define an outer chamber 42 between them while the inner wall 40 defines an inner chamber 44. The inflow of a thermal fluid into the outer chamber 42 is provided through channel 32. There are multiple perforations in the im er wall 40 ofthe balloon, and the thermal fluid escapes into the inner chamber 44 ofthe balloon after being transiently trapped between the inner and outer layers ofthe balloon for more efficient thermal fransfer through the outer balloon wall 12a. The thermal fluid then escapes into the space between the outer core catheter 8 and the movable core catlieter 33 and is collected into an attached bag at the proximal end ofthe catheter assembly outside the patient. All other components ofthe system and mechanisms of its delivery/retrieval and operation remain the
same as described above in the embodiments of FIGS. 4, 5, 6 and 7.
The systems comprising the sleeve type balloon (FIGS. 1-3) and the solid type balloons (FIGS. 4-10), provided with the stent-capturing hooks 17, are beneficial for primary delivery, repositioning or removal of stents including stent-graft devices or covered/coated
stents.
Referring to FIG. 11, a clinical scenario of primary stent delivery and deployment into a focal narrowing 80a of a vessel 80 is shown in stages. The stent is formed in accordance with the method ofthe invention of either a one-way or two-way shape memory alloy having a first transition temperature at or below the body temperature. In utilizing the apparatus described above for primary stent delivery, a stent is initially mounted on the thermal transfer
device in its collapsed condition and so that the stent is in thermal transfer relationship with the collapsed thermal transfer device. Preferably, the system is provided to the operator in a closed configuration (seen in FIG.1 lb) in which the stent-receiving sheath 11 is in a forward position covering the collapsed stent 90, which has already been preloaded or mounted (such as by crimping) in contacting engagement over the collapsed balloon 12 and with the stent capturing hooks 17 secured to it. In the closed configuration, the distal end 11a ofthe stent-receiving sheath 11 is received in a groove 2a of conus 2 to seal the space within sheath 11 from the entry of blood or other body fluids in vessel 80 during delivery.
The system is introduced into the vessel and positioned under direct fluoroscopic guidance (with the assistance of positioning markers 15) such that the position l ib ofthe delivery system with the premounted stent 90 is situated in the area of narrowing 80a of vessel 80 (FIG.1 lb). During this delivery, the stent-receiving sheath 11 at least partially thermally insulates the collapsed stent 90 from body heat thereby maintaining the temperature ofthe stent 90 below body temperature.
Referring to FIG. lie, deployment of stent 90 begins when the operator retracts or withdraws the stent-receiving sheath 11 exposing the collapsed stent 90 mounted on the collapsed balloon 12 to the vessel interior and to body heat (see FIG. 24b). The circulation
of a cold liquid or gas through the chamber of balloon 12 is started at about the same time as the sheath 11 is withdrawn. For example a cool saline solution is infused from the proximal end ofthe catheter assembly 50A through inflow channel 14 into the balloon chamber through port 14a and recirculates back through port 13a and outflow channel 13. The temperature ofthe stent 90 is thereby maintained below the transition temperature preventing premature expansion ofthe stent by the local transfer of thermal energy through the wall of the balloon 12 into the thermal transfer fluid. The balloon 12 remains in its collapsed position at this time by maintaining the outflow channel 13 open. A precise positioning of stent 90 is enabled by controlling the expansion of stent 90 through the circulation of cooling thermal fluid even after the sheath 11 is retracted and the stent is exposed to body temperature. When the operator is satisfied that the stent 90 is precisely positioned in the desired location 80a ofthe focal narrowing of vessel 80, the stent-capturing hooks 17 are
opened and discomiected from stent 90 by further withdrawing ofthe stent-receiving sheath 11 with respect to the stent-capturing sheath 19, and the infusion ofthe cooling thermal fluid is stopped. The opened hooks are withdrawn toward the stent- receiving sheath before the stent expands to avoid interference with the stent as it expands. The stent 90 then warms naturally to body temperature through contact with surrounding blood or other body fluids or gas, and expands towards its original predetermined shape (FIG.1 Id). The stent is thus deployed into supporting engagement with the wall of vessel 80 and exerts an outward force against the wall to open the focal narrowing 80a of vessel 80.
Balloon angioplasty ofthe deployed stent can then be performed if clinically indicated. This can be achieved by closing the outflow channel 13 with a provided stop-cock. The balloon is expanded by expansion ofthe frame assembly 62 and infusion of a contrast material diluted in normal saline through the infusion port 14a, which allows visualization of the balloon under real time radiological control (FIG.l le). Opening the frame assembly 62 is achieved by moving the outer core catheter 8 forward relative to inner core catheter 3 which helps expansion ofthe balloon 12. High pressure can be achieved inside the balloon 12, which is regulated and controlled by a pressure manometer connected to the inflow channel outside the patient. Angioplasty (FIG.l le) can be performed sequentially several times if so desired clinically.
The balloon 12 is then deflated by opening the outflow channel 13 and the frame
assembly 62 collapsed by moving the outer catheter 8 back (FIG.l lf). The collapsed balloon is then withdrawn back into the stent-receiving sheath 11 whereupon the system can be removed from the body, leaving the stent in place (FIG.l lg). As noted above, this system can be used for deployment of stents exhibiting one-way or two-way memory.
The same system can be used for delivery and precise positioning of stents which are formed of shape-memory alloys that have a transition temperature greater than body temperature and which therefore expand to their predetermined configurations at temperatures higher than body temperature. Such a stent is delivered in the area of interest in the collapsed state covered with the outer sheath 11 and then exposed by moving the sheath 11 backwards. No infusion of cold thermal transfer fluid is needed to keep the stent in its collapsed state since the temperature ofthe stent will only rise to body temperature which is below the transition temperature. The stent therefore remains mounted on the collapsed balloon 12 secured to the catlieter assembly by stent-capturing hooks. When the position of
the device is adjusted and the desired location ofthe stent is confirmed, the stent-capturing hooks 17 are opened by further withdrawing ofthe stent-receiving sheath 11, releasing the stent 90 and the infusion of a warm solution at least at the transition temperature which is
higher than body temperature is started through the inflow chamiel 14. The frame assembly 62 is opened by moving the outer core catheter 8 forward. These maneuvers allow expansion ofthe mounted stent inside the area of stenosis providing high radial force on the walls ofthe vessel due to its heating to the transformation or transition temperature. If clinically indicated a primary stent placement can be supplemented with a balloon angioplasty with the help of the same delivery system. This can be achieved by closing the outflow channel and infusion of a diluted contrast material through the inflow channel in the manner described above.
Referring to FIG. 12, a clinical scenario is given when the stent 90 has been
malpositioned inside the vessel only partially covering the area of stenosis (FIG.12a) and it is desired to reposition the stent. In this case, the stent 90 is formed of a two-way shape memory alloy. For example, the alloy may have a first transition temperature equal to or below body temperature, and a second lower transition temperature in the range of between -10°C to +35°C. The system is introduced with the balloon 12 in a collapsed state and covered with the stent-receiving outer sheath 11 (FIG.12b) and positioned at the desired location such that the collapsed balloon 12 is situated within the lumen of stent 90 that is intended to be retrieved or repositioned. The outer sheath 11 is withdrawn, the distal end 11a obtaining a flared configuration, thereby exposing the frame assembly 62A and the collapsed balloon 12 (FIG.12c). The metallic frame assembly is opened and the outer core catheter 8 advanced while the movable inner core catheter 3 is fixed in place (FIG.12d). Expansion of the frame assembly 62A brings the outer wall of balloon 12 into close contact with the stent. At this time the infusion of a cold thermal fluid into the chamber of balloon 12 is started through the inflow channel 14 and the balloon 12 is inflated without creating high internal pressure within it due to an open outflow channel 13. The diameter of he open wire frame 62A matches the internal diameter ofthe stent and the cold balloon 12 moves into direct contact with the stent, causing its local cooling to the temperature at or below the second transition temperature, e.g. in the range of -10°C to 35°C, through the thermal transfer wall forming balloon 12. The stent becomes soft and pliable at this temperature and reduces at least somewhat in diameter to separate from the wall of vessel 80. The next step includes slowly stretching the wire frame 62 to a smaller diameter by moving the outer core catheter 8 backwards and keeping the movable core catheter 3 ofthe system in the same position. This maneuver causes a slow collapse ofthe frame assembly (FIG.12e). The infusion of cold thermal transfer fluid continues, but the balloon 12 moves away from the wall ofthe vessel 80 or other tubular structure due to stretching ofthe wire frame. The stent, or its proximal end in the case where the stent is designed to operate as such, begins to collapse inwardly hugging the outer wall of balloon 12 and the frame. At this time the stent-capturing hooks 17 are maneuvered to close over the collapsed proximal end ofthe stent by suitable manipulation ofthe stent-capturing sheath 19 (FIG.12f). This causes secure fixation ofthe softened cooled stent to the catheter assembly. The stent is then drawn into the stent-receiving sheath 11 with a flared tip 11a and infusion ofthe cold solution/gas into the balloon 12 is terminated (FIG.12g). Collapse ofthe proximal end ofthe stent prevents migration ofthe device and slippage over the balloon due to persistent contact ofthe distal two thirds ofthe stent with the vessel wall, even though the entire stent becomes very soft.
The stent can be then completely removed from the body or repositioned into the proper location (FIG.12h) while inside the stent-receiving sheath 11. In this latter case, the stent is then unsheathed (FIG.12i), warms to body temperature and then expands into the original shape and diameter after the stent-capturing hooks are released (FIG.12J and FIG.12k). The reposition and retrieval system is then removed from the body and the repositioned stent remains in place (FIG.121). Stent retrieval is beneficial in patients where the indication for primary stent placement is an acute intimal dissection, where the stents are used as the vehicle for local delivery of medications or radioactive substances, or in the situations when repositioning of misplaced stent is required.
Referring to FIGS. 12m - 12p, in order to facilitate drawing the collapsed stent in the
configuration shown in FIG. 12f into the stent-receiving sheath 11, the catheter assembly may be provided with a sleeve 110 formed, for example, of polymer material, which is advanced over the collapsed stent to cover the stent whereupon the entire system, i.e. the collapsed stent situated over the collapsed balloon, is pulled into the stent-receiving sheath 11. The sleeve 110 enables a smooth retraction ofthe stent and balloon into the sheath avoiding the possibility that the edges ofthe stent may catch on the wall ofthe stent receiving sheath 11.
The sleeve 110 is supported by a stiff wire 112 that extends from the proximal end ofthe catheter assembly through the wall of sleeve 110 and which terminates at a circular snare 114
passing through and forming the open mouth of sleeve 110. After the stent is collapsed to the position shown in FIG. 12f, and is captured by stent-capturing hooks 17, the wire 112 is advanced to project the sleeve 110 from the position shown in FIG. 12m to that shown in FIG. 12n where the mouth of sleeve 110 is widened through appropriate manipulation ofthe wire 112 so that the mouth encircles the proximal end ofthe stent, and then to the position shown in FIG. 12o in which the sleeve 110 completely covers the stent and balloon. The entire system is then smoothly pulled into the stent-receiving sheath as shown in FIG. 12p. The above described method allows fast and easy covering of a captured and partially collapsed stent with a thin sleeve, preventing it potential re-expansion due to warming up by
surrounding blood flow. This technique provides smooth transition and gradual reduction in diameter of a captured stent. It ensures easier retraction ofthe entire system into the relatively low profile receiving sheath, avoiding possible capturing ofthe edges of a bare stent struts at the entry opening ofthe receiving sheath.
Referring to FIGS. 12q and 12r, a modification ofthe second solid balloon embodiment including a frame formed from scaffolding wires 5 and a fluid circulation system according to the second version ofthe type shown in FIGS. 4-7 is illustrated which is specifically designed to simplify repositioning of a previously deployed stent. In this embodiment, the stent capturing device 70 comprises several hook members 120 connected to the frame wires 5 at each ofthe distal and proximal ends ofthe balloon. The hooks at the proximal end ofthe balloon extend in the proximal direction while the hooks at the distal end ofthe balloon extend in the distal direction. The catheter assembly is positioned at the location ofthe deployed stent and the frame expanded to bring the outer wall of balloon 12 into close contact with the stent. Cold thermal transfer fluid is infused into the chamber of balloon 12 causing the stent to cool to a temperature at or below the second transition temperature. As the stent is cooled, it gradually collapses over the retracting balloon and as it contracts, the hooks 120 capture the stent as seen in FIG. 12q. The balloon and stent, captured by hooks 120, continue to collapse until reaching the condition shown in FIG. 12r. Since the stent is captured by the hooks at both its distal and proximal ends, the stent and balloon need not be withdrawn into the stent receiving sheath but can then be repositioned to the precise desired location in the condition shown in FIG. 12r. When the stent has been repositioned, the flow of cold thermal fluid is discontinued allowing the stent to warm to body temperature and expand fully after releasing the holding hooks..
With this apparatus the diameter ofthe stent can be reduced enough for safe repositioning, but the stent does not have to be collapsed completely because it does not have to be withdrawn into a small profile receiving sheath, like it is done for complete retrieval of the device. It is important to note that the stent can be initially delivered using a standard commercially available, modified or specifically designed delivery system used for the regular self-expanding stents.
The same system can be used for retrieval or repositioning of a stent made from two-way shape memory alloy having a first transition temperature greater than body temperature and therefore a stent expanding to its original shape at higher than body temperature. These stents require cooling to a temperature below 37°C in order to exhibit second way memory and partially collapse for safe retrieval, with all other steps similar to the ones described in connection with FIG. 12. If repositioning of such a stent is required after it has been recovered into the outer sheath, the position ofthe closed system is adjusted under direct fluoroscopic guidance. The mounted captured stent is unsheathed and stays in the collapsed state without infusion of a cold solution since the first transition temperature is greater than body temperature. After the stent is precisely positioned at the desired location, the stent-capturing hooks are opened by completely withdrawing the stent-receiving sheath 11 , releasing the stent. A warm solution is infused into the balloon chamber through the infusion port 14a and the metallic frame 62 is opened by moving the outer core catheter forward along the fixed movable core. The steps of repositioning of such a stent are the same as for the primary delivery ofthe stent with the temperature of transformation, i.e. the transition temperature, higher than body temperature, which is described above and can be supplemented with an angioplasty in the same fashion if so desired clinically. Referring to FIGS.13- 16, a first version of a third embodiment of apparatus in
accordance with the invention comprises a thermal transfer device 60C associated with a catheter assembly 50C and including a stent capturing device 70C. The thermal transfer device 60C comprises an inflatable and collapsible balloon 20 formed ofthe same type of material as that from which balloons 4 and 12 are made. The balloon 20 has a cloverleaf configuration in the cross sectional view (FIG.14a). Balloon sectors 20r204 merge with each other at the proximal and distal ends ofthe balloon (FIG.14 and FIG.15) and in the center of the balloon define radial spaces 20^4, 20^, 202.3 and 203.4 between them (FIG.14a). Each of the radial spaces are formed by a pair of opposed radially and axially extending wall members 94 extending between the outer wall of balloon 20 and the inner core catheter 3. The distal end ofthe balloon is attached to the inner core catheter 3 at the attachment ofthe cone 2 and the proximal end ofthe balloon is molded to the more proximal portion ofthe inner core catheter 3 at point 18.
The thermal transfer device 60C further includes a frame assembly 62C comprising four pairs of scaffolding wires 21, each wire having one end attached to the introducing conus 2, another end molded into the outer core catheter 8 at point 9 and a central region connected to balloon 20 by extending through passages 5a.
The stent-capturing device 70C comprises capturing wire fingers 23 situated in
respective radial spaces 20M, 20^2, 202.3 and 203 , each of which has one end attached to inner core catheter 3 and extends at an angle from the core catheter 3 between adjacent pairs of radial sectors 20r204. A pair of connecting bars or bridging members 22a, 22b extend between each pair ofthe opposed walls 94 and captures a respective one ofthe capturing wires between them. As seen in FIG. 16, when the balloon 20 is collapsed, each capturing wire finger 23 will be engaged by the bridging member 22a to automatically close the. capturing wire finger. On the other hand, when the balloon is expanded, each capturing wire finger 23 will be engaged by a bridging member 22b to automatically open the capturing wire
finger.
In order to circulate thermal transfer fluid through the chamber of balloon 20 in the first version ofthe third embodiment shown in FIGS. 13-16, inflow and outflow channels 14 and 13 are formed in the inner core catheter 3 having inflow and outflow ports 14a and 13 a.
FIG. 25 shows the proximal end ofthe system ofthe first version ofthe third embodiment shown in FIGS. 13-16 outside the patient, where the stent receiving sheath 11
has a side arm port 28 for flushing of heparinized saline to prevent thrombus formation in the space between the stent receiving sheath 11 and the outer core catheter 8. The outer core catheter 8 has a side port 28 for flushing of heparinized saline to prevent thrombus formation between the outer core catheter 8 and the inner movable core catheter 3, which itself has two side ports: one port 29 for inflow of solution/gas into the inflow channel 14 of balloon 20 and the other port 26 for outflow of a solution/gas from the outflow channel 13, which is connected to the bag (not shown).
Referring to FIG. 17, FIG. 18, FIG. 19 and FIG. 20, the proximal end ofthe cloverleaf balloon 20 is attached to the outer core catheter 8 at point 18a. A second version ofthe third embodiment ofthe invention is illustrated wherein the space between the outer core catheter 8
and the movable core catheter 3 is used as an inflow channel 25 for infusion of a thermal solution or gas into the balloon. The movable core 3 has a central lumen for the guidewire 1 and channel 13 for outflow of circulating thermal solution or gas. The rest ofthe design of this system is identical to the system of FIGS. 13-16.
FIGS. 20D-F illustrate a modification ofthe system wherein both inflow and outflow channels 25 and 31 are provided through the space defined between the outer core catheter 8 and the movable core catheter 3. The channels are separated by two dividing partitions that
extend along the entire length ofthe catheter.
FIG. 26 illustrates the proximal end ofthe system shown in FIGS. 17-20 outside the patient, where the stent receiving sheath 11 has a side arm port 28 for flushing of heparinized saline to prevent thrombus formation in the space between the stent receiving sheath 11 and the outer core catheter 8. The outer core catheter 8 has a side arm port 27 for infusion of a thermal fluid into the cloverleaf type balloon. The movable core catheter 3 has an opening of an outflow channel 26 from the balloon and is connected to the collecting bag (not shown). A stop-cock is placed on the outflow channel 26 and is closed in cases of performing a balloon angioplasty.
Referring to FIG. 21 a clinical scenario of primary stent deployment using the cloverleaf balloon system of FIGS. 17-20 is shown for deploying a stent made of a shape memory allow having a transition temperature at or below body temperature. The collapsed
stent covered with the outer sheath is positioned inside the area of focal narrowing ofthe vessel under fluoroscopic guidance (FIG.21a). The sheath is then withdrawn exposing the collapsed mounted stent and the infusion of a cold solution or gas is started immediately to control expansion ofthe stent (FIG.21b). The collapsed stent is secured with the capturing wires or fingers , which together with the local cooling prevent premature expansion ofthe device. When the position ofthe system is precisely adjusted to the desired location under fluoroscopic guidance, the infusion of a cold thermal fluid is stopped and the metallic frame assembly is expanded by moving forward the outer core catheter along the fixed movable core (FIG.21c). This allows natural heating ofthe stent to body temperature and its expansion to the original shape and diameter inside the area of stenosis, providing high radial force on the walls ofthe vessel and opening the narrowed region ofthe vessel. The primary stent deployment can be supplemented with a balloon angioplasty under high pressure, which is achieved by closing the outflow channel 13 and infusion of a diluted contrast material via the inflow channel (FIG.21d). The pressure inside the balloon is regulated by the manometer attached to the inflow port outside the patient. The balloon is then deflated by stopping the infusion ofthe contrast material and opening the outflow channel , as well as collapsing the metallic frame by moving the movable core catheter forward along the fixed outer core catheter (FIG.21e). This maneuver also causes the stent-capturing fingers or wires to slide out ofthe cellular spaces in the stent, releasing the stent from the physical restraint (FIG.21e). The collapsed metallic frame and deflated balloon are then withdrawn back into the sheath and the entire system is removed from the body, leaving the stent in place (FIG.21f).
The same system can be used for primary deployment of stents having a temperature of transformation higher than body temperature. Such stent is mounted on the balloon and delivered into the desired location inside the body covered with an outer sheath. It is then unsheathed, but does not expand until infusion of a warm solution at higher than body temperature is started via the inflow channel. The frame is then opened and the stent expands to its original shape and diameter, which it maintains after discontinuation ofthe infusion of a warm solution. The primary stent deployment can be supplemented with a balloon angioplasty in the same fashion as described above. The frame is then collapsed by moving the movable core forward along the fixed outer catheter, which provides sliding ofthe capturing wires out ofthe stent. The stent stays in place, exhibiting persistent radial force on the walls ofthe vessel or other tubular organ. The delivery system is then safely removed from the body.
Referring to FIG. 22 the steps of 2-way shape memory stent retrieval with the
cloverleaf balloon design are shown. The closed system is introduced and positioned inside the stent, which has to be removed (FIG.22a). The outer sheath is then withdrawn back and assumes a flared configuration after detaching from the introducing conus (FIG.22b). The metallic frame opens by advancing the outer core catheter along the fixed movable core and the cold thermal transfer fluid is infused into the balloon to cool the stent to the desired temperature, which is lower for stents with the first transition temperature at or below body temperature and higher (but still lower than body temperature) for stents with the first transition temperature above body temperature (FIG.22c). The outer core catheter 8 is then moved back wliile the movable core catheter 3 remains fixed in the same position, stretching the frame and collapsing the balloon. The stent, or at least its proximal end, collapses with reduction in diameter ofthe frame 62c, wliile the stent-capturing wires 23 stay open nearly touching the vessel wall (FIG.22d). The stent, or at least its proximal end, collapses over the stent capturing wires 23, which protrude through the cells ofthe stent. The stent capturing wires 23 remain open until they meet the cross bars 22 bridging the spaces between the sectors 2θ!-204 of balloon 20. Further stretching ofthe frame 62C causes closure ofthe capturing wires 23 over the balloon 20 with the stent, or its proximal portion, caught between the capturing wires 23 and the balloon 20 (FIG.22e). At this point the stent is easily drawn into the receiving sheath (FIG.22f). The next step is complete removal ofthe recovered stent from the body (FIG.22g) or adjustment of its position while the stent is still in the collapsed state within the sheath with subsequent re-deployment into the desired location, using the same sequence ofthe steps for primary stent deployment described above.
The above described methods prevent any motion ofthe delivery system during deployment. The entire stent uniformly expands at the same time inside the area of narrowing, exerting radial force on the diseased wall ofthe vessel and restoring the normal lumen and flow. All current self-expanding stents have to be unsheathed gradually, exposing immediately expanding small segments ofthe device at a time. Persistent pulling back ofthe sheath during opening ofthe stent inside the vessel can cause slight forward or backward motion ofthe device, potentially leading to misplacement ofthe stent proximal or distal to the area of interest. This problem is eliminated by the system described above.
Referring to FIG. 23, another device 70D for capturing the stent is illustrated. As the stent is cooled by the thermal transfer device 60, and partially collapses, it is grabbed on the balloon by a snare loop 30. The loose snare loop 30 is advanced around the partially collapsed stent and then tightens into a smaller loop by sliding the thin catheter over it. This maneuver securely fixes the stent to the framed balloon and promotes further mechanical collapse ofthe stent for easy insertion into the outer sheath 11.
Referring to Fig. 33, the material ofthe balloon can be microporous as shown on Fig.33. For example, the balloon 5 may be formed of any suitable material, such as PET sheet material, in which micropores 200 are formed, such as by a laser. The size and number ofthe micropores
can vary depending on the desired diffusion rate. A microporous balloon wall allows the cooling fluid to diffuse in very small quantities from inside the chamber to the outer surface ofthe balloon, providing more efficient transfer of temperature to the stent. This diffusion of the cooling fluid will not have any detectable systemic effect, but can promote fast and safe control ofthe stent temperature, regulating the crystal state of shape memory material. It is
understood that any ofthe balloons described above can be constructed of microporous material.
The catheter assembly in any ofthe above-described embodiments can include a
balloon and circulation system ofthe type shown in Fig. 34. In the embodiment of Fig. 34, the balloon 5 is attached to the inner core catheter 3 at the distal end and to the outer catheter 8 at the proximal end, with three channels provided inside the inner core catheter 3, i.e, one for a guide wire 1 and two for circulation ofthe thermal transfer fluid, providing inflow and outflow passages 14a, 13 a. This embodiment can be utilized with any of the frame and stent- capturing arrangements described above.
While the embodiments ofthe invention described above all utilize heated or cooled fluid circulating through the balloon chamber to transfer heat to or from the stent, the thermal transfer device may comprise means for directly heating the heat fransfer surface ofthe device.
FIG. 27 illustrates a solid balloon system with multiple heating electrical resistance wires 34 provided on the surface ofthe balloon 12 to provide direct heating ofthe stent when
an electrical current is passed through the wires. The wires 34 are connected to an electrical source outside the patient. This system can be beneficial for the deployment of stents having
transition temperatures above body temperature.
Referring to FIG. 28, the outer surface ofthe solid balloon 12 is provided with an electromagnetic coil 48, which is heated by generation of an electrical current from application of an external magnetic field. The electromagnetic balloon can be used for deployment of stents having transition temperatures higher than body temperature by direct heating ofthe stent or by heating fluid injected into the balloon. The same system can be used for retrieval or repositioning ofthe stents with transformation temperatures greater than body temperature by infusing a cooling solution/gas into the balloon.
While the first, second and third embodiments ofthe invention described above utilize thermal transfer fluid which is heated or cooled at the proximal end ofthe catheter assembly outside the body, other techniques for heating the thermal fluid may be employed.
FIG. 29 illustrates a solid balloon system with an electromagnetic coil 49 inside the balloon (as opposed to outside the balloon as shown in FIG. 28) to provide heating ofthe fluid in the balloon chamber after application of an external magnetic field. It is applicable for the deployment, repositioning or retrieval ofthe stents with first transformation temperatures higher than body temperature.
FIG. 30 illustrates a thermal transfer device provided with multiple optic fibers 47 inside the balloon for heating ofthe circulating fluid by a laser beam, which is connected to a
source generator system on the proximal end outside the patient. The system can be used for the deployment, repositioning or retrieval of stents with first transformation temperatures
higher than body temperature.
Referring to FIG. 31, optic fibers 46 are situated on the outer surface ofthe balloon and can be used for direct heating ofthe mounted stent or for heating of fluid circulating inside the balloon. The system can be used for the deployment, repositioning or retrieval of the stents with transition temperature higher than body temperature.
FIG. 32 demonstrates another system with an ultrasound probe 51 inside the balloon, which provides fast heating ofthe circulating fluid for the deployment of stents with transition temperatures higher than body temperature. An ultrasound generator is connected to the system on the proximal end outside the patient. The system can be also used for repositioning or retrieval ofthe same stents by circulation of cooling thermal fluid inside the
balloon.
All currently available and all future stents and stent-grafts made from Nitinol or other materials with shape memory capabilities can be delivered with the above described systems and after training or heat/mechanical treatment can demonstrate second way memory effect, and can be retrieved from the body or repositioned into the desired location by using the systems that are described in this patent.
Obviously, numerous variations ofthe present invention are possible within the scope ofthe claims appended hereto. Accordingly, the invention may be practiced otherwise than as specifically described herein.

Claims

CLAIMSWE CLAIM:
1. A method of delivering a shape memory stent having a transition temperature at or below body temperature to, and deploying the stent at a diseased tubular area in the body, comprising the steps of: mounting the shape memory stent in a collapsed condition on a thermal transfer device coupled to a catlieter assembly, said thermal transfer device including a chamber having an outer transfer themial wall, such that the heat transfer wall is in local heat transfer relationship with the stent; delivering the stent in said collapsed condition on said thermal transfer device to a region ofthe diseased tubular area in the body;' infusing a flow of cooling thermal fluid into said chamber, commencing at least as early as the time the stent in its collapsed condition on the thermal transfer device has been delivered to a region ofthe diseased tubular area; if necessary, adjusting the position ofthe stent in said collapsed condition on said thermal transfer device in said narrowing tubular area; controlling the expansion of said stent into supporting engagement with the wall of the diseased tubular area by adjusting the temperature and/or rate of the inflow of cooling thermal fluid into said chamber.
2. The method of claim 1 further including the steps of, during said delivery step, shielding the collapsed stent on the thermal transfer device to at least partially inhibit the heating ofthe stent to body temperature by the surrounding body tissue during said delivery step; and exposing the collapsed stent to the body upon substantial completion of said delivery
step; and wherein said infusing step commences upon substantial completion of said delivery step and upon exposing ofthe collapsed stent to the body.
3. The method of claim 2 wherein said shielding step comprises covering said collapsed stent on the thermal transfer device with a movable outer sheath situated in a forward position and forming part of said catheter assembly during delivery, and said exposing step comprises withdrawal of said outer sheath to a retracted position.
4. The method of claim 1 wherein said infusing step commences at the substantial commencement of said delivery step.
5. The method of claim 1 including the further steps of, releaseably capturing said stent to said catheter assembly at the time of said mounting
step; maintaining said capture of said stent to said catheter assembly during said delivery step; maintaining said capture of said stent to said catheter assembly during at least a part of said deploying step; and releasing said stent from capture to said catheter assembly after completion of at least a part of said deploying step.
6. The method of claim 5 wherein said step of releasing said stent from capture to said catlieter assembly commences substantially upon completion of said deploying step.
7. The method of claim 5 wherein said catheter assembly comprises a stent-capturing sheath having a distal end; at least one hook member affixed to said distal end of said stent-capturing sheath; and an outer sheath having a distal end movably positioned over said stent-capturing
sheath; and wherein said releasing step comprises moving said outer sheath with respect to said stent-capturing sheath whereupon said distal end of said outer sheath cooperates with said at least one hook member to move the same to release said stent.
8. The method of claim 5 wherein said thermal transfer device comprises a balloon expandable and collapsible between expanded and collapsed conditions.
9. The method of claim 8 wherein subsequent to the step of deploying said stent into supporting engagement with the wall ofthe diseased tubular area, performing a balloon
angioplasty by expanding said balloon to engage said deployed stent and forcefully urge said stent against the wall ofthe diseased tubular area.
10. The method of claim 9 wherein said catheter assembly comprises inflow passage means through which cooling thermal fluid is infused into said chamber during said infusing step and outflow passage means for providing a controllable outflow of cooling thermal fluid from said chamber, and wherein said step of performing an angioplasty by expanding the balloon comprises expanding the balloon by inflation under pressure by infusing fluid under pressure into said chamber and
controlling the outflow ofthe fluid from said chamber to inflatingly expand said balloon under internal pressure into an expanded condition to engage said deployed stent and
forcefully urge said stent against the wall ofthe narrowing tubular area.
11. The method of claim 10 wherein said step of performing an angioplasty further comprises, in conjunction with said inflation ofthe balloon, actuating mechanical means coupled to said balloon for mechanically expanding the balloon into an expanded condition to engage said deployed stent and forcefully urge said stent against the wall ofthe diseased tubular area.
12. The method of claim 8 wherein said releasing step comprises releasing said stent from capture to said catheter assembly by means activated by expansion of said balloon.
13. The method of claim 11 wherein said catheter assembly comprises an inner core catheter and a relatively movable outer core catheter situated over said inner core catheter, said outer core catheter having a distal end which is situated proximally ofthe distal end of said inner core catheter so that projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter, and a wire frame comprising a plurality of wires, each wire having one end affixed to a distal end of said projecting portion of said inner core catheter, another end affixed to the distal end of said outer core catheter, and a mid-region attached to said expandable balloon; and wherein said actuating step comprises moving said inner and outer core catheters with respect
to each other to bend said wires in an outward direction and thereby expand said balloon.
14. A method of delivering a shape memory stent having a transition temperature at or
below body temperature to, and deploying the stent at, a diseased tubular area within the body, comprising the steps of: mounting the shape memory stent in a collapsed condition on an inflatable balloon in a collapsed condition coupled to a catheter assembly, said balloon having a chamber and having an outer heat transfer wall, such that the heat transfer wall is in local heat transfer relationship with the stent; delivering the stent in said collapsed condition on said collapsed balloon to a region of the diseased tubular area in the body; commencing a circulating flow into and from said chamber of said balloon at least as early as the time the stent in its collapsed condition on the collapsed balloon has been delivered to a region ofthe diseased tubular area; said circulating flow comprising infusing a flow of cooling thermal fluid from a proximal end ofthe catheter assembly into said chamber of said balloon, and withdrawing a flow of cooling thermal fluid from said chamber of said balloon to the proximal end ofthe catheter assembly; if necessary, adjusting the position ofthe stent in said collapsed condition on said collapsed balloon in said diseased tubular area; controlling the expansion of said stent into supporting the engagement ofthe wall of the diseased tubular area by adjusting the temperature and/or rate ofthe inflow of cooling thermal fluid into said chamber.
15. The method of claim 14 wherein subsequent to the step of deploying said stent into supporting engagement with the wall ofthe diseased tubular area, performing a balloon angioplasty by expanding said balloon into an expanded condition to engage said deployed stent, and forcefully urging said stent against the wall ofthe diseased tubular area;
and wherein said catheter assembly comprises inflow passage means through which cooling thermal fluid is infused into said chamber during said infusing step and outflow passage means for providing a controllable outflow of cooling thermal fluid from said chamber, and wherein said step of performing an angioplasty by expanding the balloon comprises expanding the balloon by inflation under pressure by infusing fluid under pressure into said chamber and controlling the outflow ofthe fluid from said chamber to inflatingly expand said balloon under internal pressure into an expanded condition to engage said deployed stent and forcefully urge said stent against the wall ofthe narrowing tubular area.
16. The method of claim 15 wherein said step of performing an angioplasty further comprises, in conjunction with said inflatingly expanding the balloon, actuating mechanical means coupled to said balloon for mechanically expanding the balloon into an expanded condition to engage said deployed stent and forcefully urge said stent against the wall ofthe diseased tubular area.
17. The method of claim 16 wherein said catheter assembly comprises an inner core catheter and relatively movable outer core catheter situated over said inner core catheter, said outer core catheter having a distal end which is situated proximally ofthe distal end of said inner core catheter so that projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter, and a wire frame comprising a plurality of wires, each wire having one end affixed to a distal end of said projecting portion of said inner core catheter, another end affixed to the distal end of said outer core catheter, and a central region attached to said expandable balloon; and wherein said actuating step comprises moving said inner and outer core catheters with respect to each other to bend said wires in an outward direction and thereby expand said balloon.
18. The method of claim 14 including the further steps of, releasably capturing said stent to said catheter assembly at the time of said mounting
step; maintaining said capture of said stent to said catheter assembly during said
delivery step; maintaining said capture of said stent to said catheter assembly during at least a part of said deploying step; and releasing said stent from capture to said catheter assembly after completion of at least part of the deployment step.
19. The method of claim 18 wherein said releasing step comprises releasing said stent from capture to said catheter assembly by means activated by expansion of said balloon.
20. The method of claim 18 wherein said step of releasing said stent from capture to said catheter assembly commences substantially upon completion of said deploying step.
21. The method of claim 18 wherein said catheter assembly comprises a stent-capturing sheath having a distal end; at least one hook member affixed to said distal end of said stent-capturing sheath; and an outer sheath having a distal end movably positioned over said
stent-capturing sheath; and wherein said releasing step comprises moving said outer sheath with respect to said stent-capturing sheath whereupon said distal end of said outer sheath cooperates with said at least one hook member to move the same to release said sheath.
22. A method of delivering a shape memory stent having a transition temperature greater than body temperature to, and deploying the stent at, a diseased tubular area within the body, comprising the steps of: mounting the shape memory stent in a collapsed condition on a thermal transfer device coupled to a catheter assembly, said thermal transfer device including a chamber having thermal transfer wall, such that the heat transfer wall is in local heat transfer relationship with the stent; delivering the stent is said collapsed condition on said thermal transfer device to a region ofthe diseased tubular area in the body; controlling the expansion of said stent into supporting engagement with the wall of the diseased tubular area by infusing a flow of heating thermal fluid into said chamber, commencing only after the time the stent in the collapsed position on the thermal transfer device has been delivered to a region ofthe diseased tubular area.
23. A method of delivering a shape memory stent having a transition temperature at or below body temperature to, and deploying the stent at, a diseased tubular area in the body comprising the steps of: mounting the shape memory stent in a collapsed condition on an inflatable balloon in a collapsed condition coupled to a catheter assembly, said balloon having a chamber having
an outer thermal transfer wall, such that the thermal transfer wall is in local heat transfer relationship with the stent; delivering the stent in said collapsed condition on said collapsed balloon to a region of the narrowing tubular area in the body; commencing a circulating flow into and from said balloon at least as early as the time the stent in its collapsed condition on the collapsed balloon has been delivered to a region of the diseased tubular area, said circulating flow comprising an inflow of cooling thermal fluid from a proximal end ofthe catheter assembly into said chamber of said balloon, and an outflow from the chamber of said balloon to the proximal end ofthe catheter assembly; if necessary, adjusting the position ofthe stent in said collapsed condition on said balloon in said diseased tubular area; controlling the expansion ofthe stent into supporting engagement with the wall ofthe diseased tubular area by adjusting the rate and/or the temperature of the inflow of cooling thermal fluid into said chamber; and during said controlled expansion step, at least partially expanding the balloon.
24. The method of claim 23 wherein said step of expanding the balloon comprises controlling a circulating flow of fluid to and from the chamber of said balloon.
25. The method of claim 24 wherein said step of controlling the circulating flow comprises controllably occluding said outflow from said chamber.
26. The method of claim 24 wherein said expansion fluid comprises said thermal transfer
fluid.
27. The method of claim 24 wherein said step of expanding the balloon comprises expanding a frame assembly on said catheter assembly and to which said balloon is attached.
28. The method of claim 27 wherein the catheter assembly comprises an inner core catheter and a relatively moveable outer core catheter situated over said inner core catheter, said outer core catheter having a distal end which is situated proximally ofthe distal end of said inner core catheter so that a projecting portion of said inner core catheter extends beyond said distal end region of said outer core catheter, and wherein said frame assembly comprises a plurality of wires, each wire having one end fixed to a distal end of said projecting portion of said inner core catheter, another end fixed to the distal end of said outer core catheter, and a central region attached to said expandable balloon.
29. The method of claim 23 wherein subsequent to the step of deploying said stent into supporting engagement with the wall ofthe narrow tubular area, performing a balloon angioplasty by expanding said balloon into an expanded condition to engage said deployed stent and forcefully urge said stent against the wall of a
narrow tubular area.
30. The method of claim 29 wherein said step of performing an angioplasty by expanding the balloon comprises expanding the balloon by inflation under pressure by infusing a fluid under pressure into said chamber of said balloon and restricting the outflow ofthe fluid from said chamber.
31. The method of claim 30 wherein said catheter assembly comprises an expandable frame assembly to which said balloon is attached to said catheter assembly, and wherein said step of performing an angioplasty further includes expanding said frame assembly on the catheter assembly.
32. The method of claim 23 wherein during said mounting step, releaseably capturing said stent in said collapsed condition to said catheter assembly by capturing means moveably affixed to said catheter assembly and coupled to said balloon; and wherein said step of expanding the balloon during deployment causes movement of said capturing means to maintain connection between said catheter assembly and said stent as said stent expands; and wherein subsequent to deployment, releasing said capturing means from said stent by
collapsing said balloon.
33. A method of delivering a shape memory stent to, and deploying the stent at, a diseased tubular area in the body, comprising the steps of: mounting a stent in a collapsed condition on a thermal transfer device coupled to a
catheter assembly, said thermal transfer device including a thermal transfer surface such that the thermal transfer surface is in local heat transfer relationship with the stent; delivering the stent in its collapsed condition on the thermal transfer device to a region ofthe diseased tubular area in the body; after delivery, adjusting the temperature ofthe thermal transfer surface to adjust the temperature ofthe stent in local thermal transfer relationship to control the expansion of said stent to an expanded condition whereupon the stent is deployed.
34. The method of claim 33 wherein the shape memory stent has a transition temperature at or below body temperature, and wherein said temperature adjusting step comprises raising the temperature ofthe thermal transfer surface from a temperature below body temperature to allow the temperature ofthe stent to warm naturally to body temperature.
35. The method of claim 33 wherein the shape memory stent has a transition temperature above body temperature, and wherein said temperature adjusting step comprises raising the temperature ofthe thermal transfer surface from body temperature to heat the stent to at least
the transition temperature.
36. The method of claim 33 wherein said temperature adjusting step comprises adjusting the temperature and/or rate of inflow of cooling thermal fluid into a chamber of said thermal transfer device.
37. The method of claim 36 wherein said transfer device includes electrical heating wires in the chamber and said temperature adjusting step comprises adjusting the current flow
through the heating wires.
38. The method of claim 36 wherein said temperature adjusting step comprises directing ultrasonic energy into the chamber.
39. The method of claim 36 wherein said temperature adjusting step comprises directing laser energy into the chamber.
40. The method of claim 33 wherein said temperature adjusting step comprises directly controlling the temperature ofthe thermal transfer surface.
41. The method of claim 40 wherein the thermal transfer surface includes conductive heating wires and wherein said step of directly controlling the temperature ofthe thermal transfer surface comprises adjusting the current flowing through said heating wires.
42. The method of claim 40 said step of directly controlling the temperature of the thermal fransfer surface comprises directing laser energy onto said thermal transfer surface.
43. The method of claim 36 wherein said inflow of thermal fluid comprises circulating thermal fluid from the proximal end ofthe catheter assembly into the chamber and from the chamber to the proximal end ofthe catheter assembly.
44. The method of claim 33 including the further step of capturing the stent to the catheter assembly during delivery, and releasing the stent from the catheter assembly during expansion or upon completion of expansion.
45. The method of claim 33 wherein at least as early as completion of delivery and prior to the deployment, said step of adjusting the temperature ofthe thermal transfer surfaces comprises cooling the thermal transfer surface.
46. A method of capturing a two-way shape memory stent having first and second transition temperatures which is already deployed in supporting engagement with a vessel wall at a first position for repositioning or retrieval comprising the steps of: providing an expandable and collapsible thermal transfer device in a collapsed condition on a catheter assembly, said expandable thermal transfer device including a chamber having a thermal transfer wall; introducing said expandable thermal transfer device in its collapsed condition on said catheter assembly into the lumen ofthe deployed stent; expanding the expandable thermal transfer device until its thermal transfer wall is in local thermal transfer relationship with the deployed stent;
circulating a cooling thermal fluid from a proximal end region of said catheter assembly into said chamber of said expandable thermal transfer device and from said chamber of said thermal fransfer device to said proximal end region of said catheter assembly to thereby cool said deployed stent in local thermal transfer relationship with said thermal fransfer wall to cause the temperature ofthe stent to decrease to or below the second
transition temperature to thereby become at least partially collapsed, soft and pliable; capturing said at least partially collapsed and softened stent by stent-capturing means to capture the stent to the catheter assembly.
47. The method of claim 46 wherein said expandable and collapsible thermal transfer device comprises a balloon.
48. The method of claim 46 wherein said step of expanding said thermal transfer device comprises actuating a mechanical frame assembly at said distal end of said catheter assembly coupled to said thermal transfer device until said heat transfer wall of said thermal transfer device is in local thermal transfer relationship with said deployed stent.
49. The method of claim 48 wherein said catheter assembly comprises an inner core catheter and a relatively movable outer core catheter situated over said inner core catheter, said outer core catheter having a distal end which is situated proximally ofthe distal end of said inner core catheter so that a projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter, and a wire frame comprising a plurality of wires,
each wire having one end affixed to a distal end of said projecting portion of said inner core catheter, another end affixed to the distal end of said outer core catheter, and a central region attached to said expandable balloon; and wherein
said actuating step comprises moving said inner and outer core catheters with respect to each other to bend said wires in an outward direction and thereby expand said balloon.
50. The method of claim 46 including the further step of partially collapsing said thermal transfer device after said softened stent has been captured by said stent capturing means and wherein said stent remains in constant local thermal transfer relationship with said thermal transfer wall of said thermal transfer device.
51. The method of claim 50 wherein said catheter assembly comprises an inner core catheter and a relatively movable outer core catheter situated over said inner core catheter, said outer core catheter having a distal end which is situated proximally ofthe distal end of said inner core catheter so that projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter, and a wire frame comprising a plurality of wires, each wire having one end affixed to a distal end of said projecting portion of said inner core catheter, another end affixed to the distal end of said outer core catheter, and a central region attached to said expandable balloon; and wherein
said actuating step comprises moving said inner and outer core catheters with respect to each other to bend said wires in an outward direction and thereby expand said thermal transfer device. ,
52. The method of claim 48 wherein said thermal fluid circulating step occurs at a low pressure during said balloon expansion step.
53. The method of claim 46 wherein said step of cooling said deployed stent is conducted to cause one portion ofthe stent to collapse before collapse ofthe entire stent.
54. The method of claim 46 comprising the further step of, after capturing the stent,
retrieving the stent from the body.
55. The method of claim 54 wherein said catheter assembly includes a stent-receiving sheath, and wherein said step of retrieving said stent from the body comprises the steps of: fully collapsing said thermal transfer device; positioning the softened stent into said stent-receiving sheath; and withdrawing the catheter assembly from the body.
56. The method of claim 46 comprising the further step of, after capturing the stent, repositioning the stent in a supporting engagement with a vessel wall at a second position.
57. The method of claim 56 wherein said catheter assembly includes a stent-receiving sheath, said two-way shape memory stent has a first transition temperature at or below room temperature and wherein said step of repositioning said stent at a second position comprises the steps of: fully collapsing said thermal transfer device; positioning the softened stent into said stent-receiving sheath into local thermal transfer relationship with said thermal transfer wall of said thermal transfer device; repositioning the catheter assembly in the body so that said stent, situated in said stent-receiving sheath, is repositioned at said second position; and exposing the stent from within the stent-receiving sheath to expose the stent to body temperature, whereupon said stent is heated by the body and expands into supporting engagement with the vessel wall at said second position.
58. The method of claim 56 wherein said step of repositioning said stent at a second position comprises, while maintaining circulation of said cooling thermal fluid, repositioning the catheter assembly in the body so that the stent is repositioned at said second positioning, and terminating the circulation ofthe cooling thermal fluid.
59. The method of claim 57 wherein said step of repositioning said stent comprises the further step of after exposing the stent from the stent-receiving sheath, releasing the stent from the stent-capturing means to free the stent from the catheter assembly.
60. The method of claim 56 wherein said catheter assembly includes a stent-receiving sheath, said two-way shape memory stent has a first transition temperature greater than body temperature, and wherein said step of repositioning the stent at a second position comprises the steps of: fully collapsing said thermal transfer device; drawing the softened stent into said stent-receiving sheath by said stent-capturing means into local thermal transfer relationship with said thermal transfer wall of said thermal transfer device; repositioning the catheter assembly in the body so that said stent situated in said stent-receiving sheath is repositioned at said second position; exposing the stent from the stent- receiving sheath; if necessary adjusting the position ofthe system within the diseased area; circulating a heating thermal fluid from a proximal end region of said catheter
assembly into said chamber of said thermal transfer device and from said chamber of said proximal end region of said catheter assembly to thereby heat said stent in local thermal transfer relationship with said thermal transfer wall to cause the temperature ofthe stent to increase to the first transition temperature to thereby expand into supporting engagement with the vessel wall at the second position; and releasing the stent from said capturing means,
61. A method of capturing a two-way shape memory stent which is already deployed in supporting engagement with a vessel wall, for repositioning or retrieval comprising the steps of: providing a thermal transfer device on a catheter assembly, said thermal transfer device having a thermal transfer surface; introducing the thermal transfer device into the lumen ofthe deployed stent; positioning the thermal transfer device until the thermal transfer surface is in local thermal transfer relationship with the deployed stent;
reducing the temperature ofthe thermal transfer device to thereby cool said deployed stent in local heat transfer relationship with said thermal transfer surface to cause the temperature ofthe stent to decrease to or below the second transition temperature to thereby become at least partially collapsed, soft and pliable, and separate from the vessel wall and; capturing the at least partially collapsed and softened stent by stent-capturing means to capture the stent to the catheter assembly.
62. The method of claim 61 wherein said thermal transfer device is expandable and collapsible, and wherein said thermal transfer device is introduced into the lumen ofthe deployed stent in its collapsed condition, and wherein said positioning step comprises expanding the thermal transfer device.
63. The method of claim 61 including the additional step of positioning the captured stent into an outer sheath.
64. The method of claim 63 including the further step of removing the outer sheath
containing the stent from the body to retrieve the stent.
65. The method of claim 63 including the further step of repositioning the outer sheath containing the stent at a new location in the vessel and deploying the stent at said new position.
66. Apparatus for deploying and/or retrieving and/or repositioning a stent having a shape
memory, comprising: an elongate catheter assembly having a proximal end region and a distal end region; a thermal fransfer device situated on said catheter assembly defining a chamber having a thermal transfer wall; and means for providing an inflow of thermal transfer fluid into said chamber from said proximal end region of said catheter assembly for transferring thermal energy to said stent through said thermal fransfer wall, to adjust the temperature ofthe stent.
67. Apparatus as recited in claim 66 wherein said thermal transfer device comprises an expandable member structured and arranged to expand and collapse between an expanded condition and a collapsed condition.
68. Apparatus as recited in claim 67 wherein said thermal transfer device includes an adjustable wire frame for expanding and collapsing said expandable member.
69. Apparatus as recited in claim 68 wherein said catheter assembly comprises an inner core catheter and a relatively movable outer core catheter situated over said inner core catheter, said outer core catheter having a distal end which is situated proximally ofthe distal end of said inner core catheter so that a projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter and wherein said wire frame comprises a plurality of wires, each wire having one end fixed to a distal end of said projecting portion of said inner core catheter, another end fixed to the distal end of said outer core catheter, and a central region attached to said expandable members; whereby relative movement of said inner and outer core catheters to shorten the projecting portion of said inner core bends said wires and expands said expandable member to its expanded condition while relative movement of said inner and outer core catheters to lengthen the projecting portion of said inner core straightens said wires and collapses said thermal transfer device to its collapsed
condition.
70. Apparatus as recited in claim 69 wherein said expandable member comprises an
inflatable balloon.
71. Apparatus as recited in claim 70 wherein said thermal transfer material forming said chamber comprises flexible sheet material.
72. Apparatus as recited in claim 71 wherein said thermal transfer material comprises a
polymer material.
73. Apparatus as recited in claim 67 wherein said expandable member includes a balloon formed at least in part of said thermal transfer wall of said chamber.
74. Apparatus as recited in claim 73 wherein said means for providing inflow of thermal transfer fluid into said chamber comprises means for inflating said balloon member.
75. Apparatus as recited in claim 73 wherein said catheter assembly includes means for expanding and collapsing said balloon.
76. Apparatus as recited in claim 66 wherein said means for providing an inflow of
thermal transfer fluid into said chamber comprise passages formed at least in part in said elongate catheter assembly.
77. Apparatus as recited in claim 76 wherein said passages open from said catheter assembly into the interior of said chamber of said thermal transfer device.
78. Apparatus as recited in claim 77 wherein said elongate catheter assembly comprises an inner core catheter and a relatively movable outer core catheter situated over said iimer core catheter, and wherein said opening of said passage comprises an axially facing annular opening defined between a distal end of said outer core catheter and said inner core catheter.
79. Apparatus as recited in claim 77 wherein said catheter assembly comprises an inner core catheter, and wherein said opening of said passage comprises a radially facing opening constituting a port formed in a side wall of said inner core catheter.
80. Apparatus as recited in claim 76 wherein said passage opens at said catheter assembly at a port situated at the exterior of said chamber, and wherein said inflow providing means further comprises separate conduit means fluidly communicating said port and said chamber interior.
81. Apparatus for deploying, retrieving and/or repositioning a stent having a shape memory, comprising: an elongate catheter assembly having proximal and distal end regions;
a thermal transfer device including a balloon member operatively connected to said catheter assembly defining a chamber having a thermal fransfer wall, at least a part of which constitutes a thermal transfer material; and circulation means for providing an inflow of thermal transfer fluid into the interior of said chamber for transferring thermal energy to a stent through said outer thermal transfer wall to adjust the temperature ofthe stent, and for providing an outflow of thermal transfer fluid from the interior of said chamber to said proximal end region of said catheter assembly.
82. Apparatus as recited in claim 81 wherein said balloon member comprises a
sleeve-type balloon expandable to an expanded condition and collapsible to a collapsed position, said balloon member comprising a chamber which in its expanded condition has an annular cross-section and defines an axially extending through-passage.
83. Apparatus as recited in claim 82 wherein said catheter assembly comprises at least one core catheter; and wherein said circulation means includes an inflow lumen formed in said core catheter, an inflow tube fluidly interconnecting the distal end ofthe inflow lumen and the interior of said chamber, an outflow lumen formed in said core catheter between said proximal and distal end regions; and an outflow tube fluidly interconnecting the distal end of said outflow lumen and said interior of said chamber.
84. Apparatus as recited in claim 82 wherein said thermal fransfer device further comprises an adjustable wire frame operatively associated with said catheter assembly for expanding and collapsing said balloon member.
85. Apparatus as recited in claim 84 wherein said catheter assembly comprises an im er core catheter and an outer core catheter situated over said inner core catheter, said outer core catheter having a distal end which is situated proximally ofthe distal end of said inner core catheter so that a projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter; and wherein said wire frame comprises a plurality of wires, each wire having one end fixed to a distal end of said projecting portion of said inner core catheter, another end fixed to the distal end of said outer core catheter and a central region attached to said balloon member, whereby relative movement of said iimer and outer core catheters to shorten the projecting portion of said inner core bends said wires and expands said balloon member while relative movement of said inner and outer core catheters to lengthen the projecting portion of said inner core catheter straightens said wires and collapses said balloon member.
86. Apparatus as recited in claim 81 wherein said catheter assembly comprises at least one core catheter, and wherein said balloon member has a distal end sealed in fluid sealing relationship around the circumference of said core catheter and a proximal end also sealed in fluid sealing relationship around the circumference of said core catheter.
87. Apparatus as recited in claim 86 wherein said circulation means comprise at least one pair of inflow and outflow lumens formed in said core catheter substantially between said proximal and distal end regions of said catheter assembly; said lumens having distal ends opening at ports into the interior of said chamber.
88. Apparatus as recited in claim 87 wherein said balloon member comprises a solid- type balloon expandable to an expanded condition and collapsible to a collapsed condition, said balloon member comprising a chamber which in its expanded condition has a disk-like cross section.
89. Apparatus as recited in claim 88 wherein said catheter assembly further includes an outer core catheter situated over said inner core catheter so as to be relatively movable with respect thereto, said outer core catheter having a distal end which is situated proximally of the distal end of said imier core catheter, so that a projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter.
90. Apparatus as recited in claim 89 wherein thermal transfer device includes an adjustable wire frame for expanding and collapsing said balloon member.
91. Apparatus as recited in claim 90 wherein said adjustable wire frame comprises a plurality of wires, each wire having one end fixed to a distal end of said projecting portion of said imier core catheter, another end fixed to the distal end of said outer core catheter and a central region attached to said balloon member, whereby relative movement of said imier and outer core catheters to shorten the projecting portion of said inner core bends said wires and expands said balloon member while relative movement of said inner and outer core catheters to lengthen the projecting portion of said inner core catheter straightens said wires and collapses said balloon member.
92. Apparatus as recited in claim 87 wherein said balloon member comprises a balloon having at least one longitudinal fold attached to the inner core catheter along its axis and expandable to an expanded condition, and collapsible to a collapsed condition, said balloon member comprising a chamber which in its expanded condition, has at least one radial groove
in cross-section.
93. Apparatus as recited in claim 92 wherein said catheter assembly further includes an outer core catheter situated over said inner core catheter so as to be relatively movable with
respect thereto, said outer core catheter having a distal end which is situated proximally of the distal end of said inner core catheter, so that a projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter.
94. Apparatus as recited in claim 93 wherein said thermal transfer device includes an adjustable wire frame for expanding and contracting said balloon member.
95. Apparatus as recited in claim 94 wherein said adjustable wire frame comprises a plurality of wires, each wire having one end fixed to a distal end of said projecting portion of said inner core catheter, another end fixed to the distal end of said outer core catheter and a central region attached to said balloon member, whereby relative movement of said inner and outer core catheters to shorten the projecting portion of said inner core bends said wires and expands said balloon member while relative movement of said inner and outer core catheters
to lengthen the projecting portion of said inner core catheter straightens said wires and collapses said balloon member.
96. Apparatus as recited in claim 81 wherein said catheter assembly comprises an inner core catheter and an outer core catheter situated over said inner core catheter and relatively movable with respect thereto, said outer core catheter having a distal end which is situated proximally ofthe distal end of said inner core catheter, so that a projecting portion of said imier core catheter extends beyond said distal end of said outer core catheter; and wherein said balloon member has a distal end sealed in fluid sealed relationship around the circumference of a distal end region of said inner core catheter, and said balloon member has a proximal end sealed in fluid sealed relationship around the circumference of a distal end region of said outer core catheter.
97. Apparatus as recited in claim 96 wherein said circulation means include at least one of an inflow and outflow passage comprising passage means formed in said catheter assembly extending from the proximal end region thereof and opening at said distal end region thereof at an axially facing annular opening defined between the inner core catheter and the distal end of said outer core catheter.
98. Apparatus as recited in claim 96 wherein said balloon member is expandable to an expanded condition and collapsible to a collapsed condition, said balloon member comprising a chamber which in its expanded condition has a disk-like cross-section.
99. Apparatus as recited in claim 98 wherein said thermal transfer device includes an adjustable wire frame for expanding and collapsing said balloon member.
100. Apparatus as recited in claim 99 wherein said wire frame assembly comprises a plurality of wires, each wire having one end fixed to a distal end of said projecting portion of said imier core catheter, another end fixed to the distal end of said outer core catheter and a central region attached to said balloon member, whereby relative movement of said inner and outer core catheters to shorten the projecting portion of said inner core bends said wires and expand said balloon while relative movement of said inner and outer core catheters to lengthen the projecting portion of said inner core catheter straightens said wire and collapses said balloon member.
101. Apparatus as recited in claim 96 wherein said balloon member comprises a balloon having at least one longitudinal fold attached to the inner core catheter along its axis and expandable to an expanded condition, and collapsible to a collapsed condition, said balloon member comprising a chamber which in its expanded condition, has at least one groove in cross section defining space between them.
102. Apparatus as recited in claim 101 wherein said thermal transfer device includes an adjustable wire frame for expanding and collapsing said balloon member.
103. Apparatus as recited in claim 102 wherein said wire frame assembly comprises a plurality of wires, each wire having one end fixed to a distal end of said projecting portion of said imier core catheter, another end fixed to the distal end of said outer core catheter and a central region attached to said balloon member, whereby relative movement of said iimer and outer core catheters to shorten the projecting portion of said inner core bends said wires and expands said balloon member while relative movement of said iimer and outer core catheters to lengthen the projecting portion of said inner core catheter straightens said wires and collapses said balloon member.
104. Apparatus as recited in claim 81 wherein said chamber of said balloon member comprises an outer chamber portion at least partially defined by said outer wall and an inner chamber portion in fluid communication with said outer chamber portion, and wherein said circulation means comprise means for providing an inflow of thermal transfer fluid from the proximal end region of said catheter assembly into the interior of said outer chamber portion and means for providing an outflow of thermal transfer fluid from said inner chamber portion to the proximal end region ofthe catheter assembly.
105. Apparatus as recited in claim 81 wherein said catheter assembly includes an iimer core catheter and a relatively movable outer core catheter situated over the inner core catheter, said outer core catheter comprising a concentric fluid passage divided into at least two sub-passages; and wherein said circulation means comprise means for providing one of an inflow and outflow of thermal transfer fluid from the proximal end region of said catheter assembly into the interior of said chamber through the concentric walled fluid passage of said outer core catlieter; and the other of said inflow and outflow of heat transfer fluid from the proximal end
region of said catheter assembly into the interior of said chamber through an annular catheter space defined between the other of said sub-passages.
106. Apparatus for deploying, retrieving and/or repositioning a stent having a shape memory, comprising: an elongate catheter assembly having proximal and distal end regions;
a thermal transfer device comprising an expandable member situated on said catheter assembly defining a chamber having a thermal transfer wall, at least a portion of which constitutes a heat transfer material, said expandable member being expandable and collapsible between expanded and collapsed conditions;
circulation means for providing an inflow of thermal transfer fluid from the proximal end region of said catheter assembly into the interior of said chamber and for providing an outflow of thermal transfer fluid from the interior of said chamber to the proximal end region of said catheter assembly; and a stent-capturing device situated on said catheter assembly for releasably holding a stent situated at said expandable member during deployment, and releasably grasping said stent during its retrieving and/or repositioning.
107. Apparatus as recited in claim 106 wherein said stent capturing device comprise hook members situated in the region of said expandable member and structured and arranged to hold the stent during delivery, and/or grab the stent during retrieval and/or repositioning.
108. Apparatus as recited in claim 107 wherein said hook members are structured and arranged to capture the stent in a collapsed condition and to continue to capture the stent as it expands radially from said collapsed condition during deployment.
109. Apparatus as recited in claim 106 wherein said catheter assembly comprises at least one core catheter and wherein said stent-capturing device includes a plurality of stent-capturing members and a stent-capturing sheath positioned over said core catheter and moveable with respect thereto, said stent-capturing members being connected to a distal end of said stent-capturing sheath.
110. Apparatus as recited in claim 109 wherem said catheter assembly further comprises a stent-receiving sheath positioned over said stent-capturing sheath to be moveable with respect thereto, said stent-receiving sheath structured and arranged to engage said stent-capturing members upon movement of said stent-capturing and stent-receiving sheaths with respect to each other to thereby cause or permit said stent-capturing members to move in a radial direction.
111. Apparatus as recited in claim 106 wherein said expandable member of said thermal transfer device comprises a balloon member, and wherein said catheter assembly includes a core catheter over a distal end region of which said balloon member is situated; and said balloon member in its expanded condition includes at least one pair of radially and axially extending opposed wall members extending longitudinally between said outer wall of said balloon member and said core catheter, said opposed wall members at least in part forming said chamber and defining a radial space external of said chamber therebetween; said stent-capturing means including at least one hook member, situated in said radial space, one end of said at least one hook member being coupled to said core catheter.
112. Apparatus as recited in claim 111 wherein said balloon member further includes means situated in said radial space for engaging said at least one hook member upon expansion of said balloon member to its expanded condition to move the hook member and for engaging said at least one hook member upon collapse of said balloon member to its collapsed condition to move the hook member.
113. Apparatus as recited in claim 106 wherein said expandable member of said thermal transfer device comprises a balloon member; and wherein said stent capturing device comprises at least one wire finger, each wire finger having a first end secured to said catheter assembly and a body portion slidably secured to said balloon member to open upon expansion of said balloon member and close upon collapse of said balloon member.
114. Apparatus as recited in claim 113 further comprising an adjustable wire frame operatively associated with said catheter assembly for expanding and collapsing said balloon
member, said wire frame including at least one pair of wires coupled to said balloon having a bridging member; and wherein said body portion of said wire finger engages said bridging member to slidably secure said wire finger to said balloon member.
115. Apparatus as recited in claim 113 further comprising an adjustable wire frame
operatively associated with said catheter assembly for expanding and collapsing said balloon member, said wire frame including at least one wire coupled to said balloon; a guide affixed to said wire; and wherein said body portion of said wire finger passes through said guide to slidably secure said wire finger to said balloon member.
116. Apparatus for deploying, repositioning and/or retrieving a stent, comprising: an elongate catheter assembly having a proximal end region and a distal end region; a thermal transfer device comprising a collapsible sleeve-type balloon member comprising a chamber which in its expanded condition has an annular cross-section, said balloon being situated at said distal end of said catheter assembly, said balloon member having an outer wall formed at least in part of heat transfer material; mechanical means for selectively expanding and collapsing said balloon member operable from said proximal end region of said catheter assembly; thermal transfer fluid circulating means for circulating a thermal transfer fluid from the proximal end of said catheter assembly into said chamber of said balloon member and back to said proximal end region of said catheter assembly; and stent-capturing means situated at said distal end region of said catheter assembly for releasably holding said stent during deployment, and grasping said stent during retrieval and/or repositioning.
117. Apparatus as recited in claim 116 wherein said catheter assembly comprises an inner core catheter and a relatively movable outer core catheter situated over said imier core catheter, said outer core catheter having a distal end which is situated proximally ofthe distal end of said inner core catheter, so that a projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter; and wherein said mechanical means for expanding and collapsing said balloon member comprises a frame assembly comprising a plurality of wires, each wire having one end fixed
to a distal end of said projecting portion of said inner core catheter, another end fixed to the distal end of said outer core catheter and a central region attached to said balloon member, whereby relative movement of said imier and outer core catheters to shorten the projecting portion of said inner core bends said wires and expands said balloon member while relative movement of said inner and outer core catheters to lengthen the projecting portion of said inner core catheter straightens said wires and collapses said balloon member.
118. Apparatus as recited in claim 116 wherein said stent-capturing means comprise a relatively movable stent-capturing sheath situated over said outer core catheter and a relatively moveable stent-receiving sheath situated over said stent capturing sheath; and hook members affixed to a distal end of said stent-capturing sheath which engage said stent-receiving sheath to move in a radial direction in response to relative movement between said stent-capturing sheath and said stent-receiving sheath.
119. Apparatus for deploying, repositioning and/or retrieving a stent, comprising: a catheter assembly having a proximal end region and a distal end region; a thermal transfer device comprising an expandable member comprising a chamber which in its expanded condition has a circular disk shape transverse cross- section, said expandable member having an outer wall formed at least in part of heat transfer material; mechanical means for selectively expanding and collapsing said expandable member operable from said proximal end region of said catheter assembly; thermal fluid circulating means for circulating a thermal transfer fluid from the proximal end region of said catheter assembly into said chamber of said expandable member and back to said proximal end region of said catheter assembly; and
stent-capturing means situated at said distal end region of said catheter assembly for releasably capturing said stent during deployment, retrieval and/or repositioning.
120. Apparatus as recited in claim 119, comprising: an inner core catheter and a relatively movable outer core catheter situated over said iimer core catheter, said outer core catheter having a distal end which is situated
proximally ofthe distal end of said iimer core catheter, so that a projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter; and wherein said mechanical means for expanding and collapsing said expandable member comprises a frame assembly comprising a plurality of wires, each wire having one end fixed to a distal end of said projecting portion of said inner core catheter, another end fixed to the distal end of said outer core catheter and a central region attached to said expandable member, whereby relative movement of said inner and outer core catheters to shorten the projecting portion of said imier core bends said wires and expands said expandable member while relative movement of said imier and outer core catheters to lengthen the projecting portion of said inner core catheter straightens said wires and collapses said balloon member.
121. Apparatus as recited in claim 119 wherein said stent-capturing means comprise a stent-capturing sheath situated over said outer core catheter and a stent-receiving sheath situated over said stent-capturing sheath; and stent-capturing hooks affixed to a distal end of said stent-capturing sheath which engage said stent- receiving sheath to move in a radial direction in response to relative movement between said stent-capturing sheath and said stent-receiving sheath.
122. Apparatus for deploying, retrieving and/or repositioning a stent, comprising: a catheter assembly having proximal and distal end regions; a thermal transfer device comprising a collapsible balloon member comprising a chamber which in its expanded condition includes at least one pair of radially and axially extending opposed wall members extending longitudinally between said outer wall of said balloon member and said catheter assembly, said pair of opposed wall members at least in part forming said chamber and defining a radial space external of said chamber therebetween; mechanical means for selectively expanding and collapsing said balloon member operable from said proximal end region of said catheter assembly; thermal transfer fluid circulating means for circulating a thermal fluid from said proximal end of said catheter assembly into said chamber of said balloon member and back to said proximal end region of said catheter assembly; and stent-capturing means situated at said catheter assembly for releasably capturing said stent during deployment, retrieval and/or repositioning.
123. Apparatus as recited in claim 122 wherein said catheter assembly comprises an inner core catheter and a relatively movable outer core catheter situated over said inner core catheter, said outer core catheter having a distal end which is situated proximally ofthe distal
end of said inner core catheter, so that a projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter; and
wherein said mechanical means for expanding and collapsing said balloon comprises a frame assembly including a plurality of wires, each wire having one end fixed to a distal end of said projecting portion of said inner core catheter, another end fixed to the distal end of
said outer core catheter and a central region attached to said balloon member, whereby relative movement of said inner and outer core catheters to shorten the projecting portion of said iimer core bends said wires and expands said balloon member while relative movement of said inner and outer core catheter to lengthen the projecting portion of said inner core catheter straightens said wires and collapses said balloon member.
124. Apparatus as recited in claim 122 wherein said stent-capturing means comprise at least one hook member situated in said radial space defined by said opposed radial wall members of said balloon member.
125. Apparatus as recited in claim 122 wherein said catheter assembly comprises at least one core catheter; and wherein said circulating means comprise lumens extending between
said proximal and distal end regions of said core catheter and opening into the interior of said chamber of said balloon member.
•126. Apparatus as recited in claim 122 wherein said catheter assembly comprises an inner core catheter and a relatively moveable outer core catheter situated over said inner core catheter, said outer core catheter having a distal end which is situated proximally ofthe distal end of said inner core catheter, so that a projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter; and wherein said balloon has a distal end sealingly fixed to said projecting portion of said inner core catheter and a proximal end in sealingly engagement with the distal end of said outer core catheter; and wherein said circulating means comprises a lumen formed between the inner and outer core catheters.
127. Apparatus for deploying, retrieving and/or repositioning a stent, comprising: an elongate catheter assembly having proximal and distal end regions; a thermal transfer device operatively connected to said catheter assembly, said thermal transfer device comprising a collapsible balloon comprising a chamber which in its expanded condition comprises an outer chamber portion having an outer wall formed at least in part of heat transfer material, and an inner chamber portion in fluid communication with said outer chamber portion; mechanical means for selectively expanding and collapsing said balloon operable from said proximal end region of said catheter assembly; thermal fluid circulating means for circulating a thermal fluid from the proximal end of said catheter assembly into said outer chamber portion of said balloon and back to said proximal end region of said catheter assembly from said inner chamber portion of said balloon; and stent-capturing means situated at said distal end region of said catheter assembly for releasably capturing said stent during deployment, retrieval and/or repositioning.
128. Apparatus as recited in claim 127 wherein said catheter assembly comprises an iimer core catheter and a relatively movable outer core catheter situated over said inner core catheter, said outer core catheter having a distal end which is situated proximally ofthe distal end of said inner core catheter, so that a projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter; and wherein said mechanical means for expanding and collapsing said balloon member comprises a frame assembly comprising a plurality of wires, each wire having one end fixed to the distal end of said projecting portion of said inner core catheter, another end fixed to the distal end of said outer core catheter and a mid-region attached to said balloon member, whereby relative movement of said inner and outer core catheters to shorten
theprojecting portion of said inner core bends said wires and expands said balloon member while relative movement of said inner and outer core catheter to lengthen the projecting
portion of said inner core catheter straightens said wires and collapses said balloon member.
129. Apparatus as recited in claim 127 wherein said stent-capturing means comprise a relatively movable stent-capturing sheath situated over said outer core catheter and a relatively moveable stent-receiving sheath situated over said stent-capturing sheath; and hook members affixed to a distal end of said stent-capturing sheath which engage said stent receiving sheath to move in a radial direction in response to relative movement between said stent-capturing sheath and said stent-receiving sheath.
130. Apparatus as recited in claim 127 wherein said catheter assembly comprises an inner core catheter and a relatively moveable outer core catlieter situated over said inner core catheter, said outer core catheter having a distal end which is situated proximally ofthe distal end of said imier core catheter, so that a projecting portion of said inner core catheter extends beyond said distal end of said outer core catheter; and where said balloon has a distal end sealingly fixed to said projecting portion of said inner core catheter and a proximal end in sealing engagement with the distal end of said outer core catheter, and wherein said circulating means comprise a lumen formed between the inner and outer core catheter.
131. Apparatus for deploying and/or retrieving and/or repositioning a stent having a
shape memory, comprising an elongate catheter assembly having a proximal end region and a distal end region; and a thermal transfer device operatively associated with said catheter assembly,
said thermal transfer device comprising means for effecting local heat transfer with a stent being deployed, retrieved and/or repositioned by said apparatus to control the temperature ofthe stent.
132. Apparatus as recited in claim 131 further including a stent-capturing device operatively associated with said catheter assembly, said stent-capturing device comprising means for releasably holding a stent during its deployment and/or grabbing during repositioning and/or retrieving.
133 Apparatus as recited in clam 131 wherein said thermal transfer device includes a thermal transfer surface, and means for positioning said thermal transfer surface in local tliermal transfer relationship with a stent during its deployment, retrieval and/or repositioning.
134. Apparatus as recited in claim 133 wherein said thermal transfer device includes a chamber defined at least in part by a thermal transfer wall having said thermal transfer surface.
135. Apparatus as recited in claim 131 wherein said thermal transfer device includes an adjustable member structured and arranged to expand and collapse between an expanded condition and a collapsed condition.
136. Apparatus as recited in claim 134 wherein said thermal transfer device further includes means for circulating a thermal transfer fluid through said chamber for transferring thermal energy between said fluid and the stent through said thermal transfer wall when said thermal transfer wall is in local thermal transfer relationship with the stent, and means for adjusting the temperature ofthe thermal transfer fluid.
137. Apparatus as recited in claim 136 wherein said means for adjusting the temperature ofthe thermal transfer fluid are situated at the proximal end ofthe catheter assembly.
138. Apparatus as recited in claim 136 wherem said means for adjusting the temperature ofthe thermal transfer fluid comprises at least one optic fiber, extending from the proximal end of said catheter assembly and terminating in said chamber of said thermal transfer device, for transmitting a laser beam into said chamber to adjust the temperature ofthe thermal transfer fluid.
139. Apparatus as recited in claim 136 wherein said means for adjusting the temperature ofthe thermal transfer fluid comprises an ultrasound probe situated in said chamber for communication with an ultrasonic generator for transmitting ultrasonic waves into the thermal transfer fluid to adjust the temperature ofthe thermal transfer fluid.
140. Apparatus as recited in claim 136 wherein said means for adjusting the temperature ofthe thermal transfer fluid comprises an electrical conductor situated in said chamber for coupling to means for generating a current in said conductor to adjust the temperature ofthe thermal transfer fluid.
141. Apparatus as recited in claim 140 wherein said electrical conductor is coiled, and wherein said current generating means comprise means for applying a magnetic field from an external source to said electrical conductor.
142. Apparatus as recited in claim 133 wherein said thermal transfer device further includes means for adjusting the temperature ofthe thermal transfer surface.
143. Apparatus as recited in claim 142 wherein said means for adjusting the temperature ofthe thermal transfer surface comprises at least one electrical conductor coupled to said thermal transfer surface for connection to current generating means.
144. Apparatus as recited in claim 143 wherein said electrical conductor is formed in a spiral-shape on said thermal transfer surface, and wherein said current generating means comprise means for applying a magnetic field to said electrical conductor.
145. Apparatus as recited in claim 142 wherein said means for adjusting the temperature ofthe thermal transfer device comprises at least one optic fiber, extending from the proximal end of said catheter assembly and terminating on said thermal transfer surface, for transmitting a laser beam along and around said thermal transfer surface.
146. Apparatus as recited in claim 131 wherein said thermal transfer device comprises at least one conductive wire surface situated on said thermal transfer surface.
147. Apparatus as recited in claim 95 further including a stent-capturing device situated in said at least one longitudinal fold for releasably holding a stent situated on said expandable member during deployment, and releasably grasping said stent during its retrieving and/or
repositioning.
148. Apparatus as recited in claim 101 further including a stent-capturing device situated in said at least one longitudinal fold for releasably holding a stent situated on said expandable
member during deployment, and releasably grasping said stent during its retrieving and/or repositioning.
149. Apparatus as recited in claim 112, wherein said engaging means comprise bridging means extending across said radial space between said opposed pair of radially extending walls.
150. Apparatus as recited in claim 122 wherein said balloon member further includes means situated within said radial space for engaging said stent-capturing means upon expansion of said balloon member to its expanded condition and to move said capturing means upon collapse of said balloon member to its collapsed condition.
151. Apparatus as recited in claim 135 wherein said adjustable member comprises an adjustable wire frame including a plurality of wires formed from electrically conductive material, and further including means for passing an electrical current through said wires to
heat the same.
152. The method of claim 56 wherein said repositioning step comprises: reducing the diameter ofthe collapsed, softened stent uniformly along its length by applying inwardly directed forces at least at the end regions ofthe stent; maintaining the reduced diameter ofthe stent, and
repositioning the stent.
153. The method of claim 152 wherein said inwardly directed forces are applied by hook members affixed to at least the end regions ofthe balloon.
154. The method of claim 46 wherein said catheter assembly includes a stent-receiving sheath, and a sleeve situated in said stent-receiving sheath movable between a retracted position within said sheath, and an advanced position outside said sheath; and further comprising the steps of: advancing the sleeve from the retracted position to the advanced position to enclose said at least partially collapsed, soft stent; and retracting the sleeve enclosing the stent into said stent-receiving sheath.
155. Apparatus as recited in claim 70 wherein said balloon is formed of fluid-impermeable material.
156. Apparatus as recited in claim 70 wherein said balloon is formed of microporous material.
157. Apparatus as recited in claim 70 wherein said balloon has an accordion-shaped configuration in its expanded condition.
158. Apparatus for repositioning a stent with two way shape memory, which has already been deployed, comprising: an elongate catheter assembly having a proximal end region and a distal end region; a thermal transfer device situated on said catheter assembly having a thermal wall for effecting local heat transfer to the already deployed stent to cause the stent to become at least partially collapsed, soft and pliable; and means for reducing the diameter ofthe collapsed, softened stent uniformly along its length by applying inwardly directed forces at least at the end regions ofthe stent.
159. The apparatus of claim 158 wherein said diameter reducing means comprise hook members affixed to at least the end regions ofthe balloon.
160. Apparatus for deploying, retrieving and/or repositioning a stent having a shape memory, comprising:
an elongate catheter assembly having proximal and distal end regions; a thermal transfer device comprising an expandable member situated on said catheter assembly having a thermal transfer wall, at least a portion of which constitutes a heat fransfer material, said expandable member being expandable and collapsible between expanded and collapsed conditions;
a stent-capturing device situated on said catheter assembly for grasping said stent during its retrieval and/or repositioning; a stent-receiving sheath; and a sleeve situated in said stent-receiving sheath movable between a retracted position within said sheath, and an advanced position outside said sheath.
PCT/US2002/013619 2001-04-27 2002-04-29 Methods and apparatus for delivering, repositioning and/or retrieving self-expanding stents WO2002087656A2 (en)

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EP02734100A EP1389977B1 (en) 2001-04-27 2002-04-29 Apparatus for delivering, repositioning and/or retrieving self-expanding stents
DE60236725T DE60236725D1 (en) 2001-04-27 2002-04-29 DEVICE FOR STORING, REPOSITIONING AND / OR REMOVING SELF-EXPANDING STENTS
AT02734100T ATE471128T1 (en) 2001-04-27 2002-04-29 DEVICE FOR DEPLOYING, REPOSITIONING AND/OR REMOVAL OF SELF-EXPANDING STENTS

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US20040210298A1 (en) 2004-10-21
US20020161427A1 (en) 2002-10-31
EP1389977A4 (en) 2006-09-27
EP1389977B1 (en) 2010-06-16
US6676692B2 (en) 2004-01-13
US6837901B2 (en) 2005-01-04
DE60236725D1 (en) 2010-07-29
AU2002305289A1 (en) 2002-11-11
EP1389977A2 (en) 2004-02-25
US20020161377A1 (en) 2002-10-31
WO2002087656A3 (en) 2003-05-08
US20040147939A1 (en) 2004-07-29
ATE471128T1 (en) 2010-07-15
US7258696B2 (en) 2007-08-21

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