WO2009116040A2 - Endoprothèse à dilatation progressive - Google Patents

Endoprothèse à dilatation progressive Download PDF

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Publication number
WO2009116040A2
WO2009116040A2 PCT/IL2009/000305 IL2009000305W WO2009116040A2 WO 2009116040 A2 WO2009116040 A2 WO 2009116040A2 IL 2009000305 W IL2009000305 W IL 2009000305W WO 2009116040 A2 WO2009116040 A2 WO 2009116040A2
Authority
WO
WIPO (PCT)
Prior art keywords
stent
elements
lumen
separately
shape memory
Prior art date
Application number
PCT/IL2009/000305
Other languages
English (en)
Other versions
WO2009116040A3 (fr
Inventor
Oded Jakov Salomon
Alon Wolf
Original Assignee
Technion Research & Development Foundation Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Technion Research & Development Foundation Ltd. filed Critical Technion Research & Development Foundation Ltd.
Publication of WO2009116040A2 publication Critical patent/WO2009116040A2/fr
Publication of WO2009116040A3 publication Critical patent/WO2009116040A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/009—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof magnetic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body

Definitions

  • the present invention relates to stents. More particularly, the present invention relates to a gradually expanding stent.
  • Stents are tubular shaped devices that are often placed, deployed, or implanted within passages, conduits, or lumens in the body as a treatment for various conditions in the lumens.
  • a stent may be implanted in a blood vessel for treatment of a stenosis, occlusion, stricture, or aneurysm in the vessel.
  • Other lumens within which stents may be implanted include, for example, various sections of the urinary tract and bile ducts.
  • the implanted stent may serve to reopen the lumen, or to reinforce or maintain the open state of the lumen.
  • a stent is designed with two states, with a different stent diameter associated with each state.
  • a stent may be inserted into a lumen while the stent is in an unexpanded, or contracted, state.
  • the diameter of the stent may be small enough to enable insertion via a catheter or other means into the lumen.
  • the diameter of the stent may be enlarged so that the stent is in an expanded, opened state.
  • the diameter of the stent may be sufficiently large so that the stent may provide a desired function, such as increasing the size of an opening in the lumen and maintaining the opening.
  • stents require use of a separate expanding device in order to mechanically apply a radially outward force on the walls of the stent so as to expand the stent to its expanded state.
  • the walls of the stent may include a collapsible and expandable wire mesh or coil.
  • An expanding device such as an inflatable balloon, may be initially inserted into the cavity of the stent in its contracted state. Pumping air or another fluid into the balloon may cause the balloon to expand. Expanding the balloon may then apply a radially outward force on the stent, thus enlarging the diameter of the stent.
  • a stent is described by, for example, Palmaz in US 4,733,665.
  • Other stents are designed to be self-expanding, without the need for a mechanical expanding device.
  • a stent may be constructed with elastic or resilient elements that tend to expand the stent.
  • a compressing force is applied in order to collapse the stent and maintain the stent in a contracted state. Removing the compressing force, for example, by removing a sheath that surrounds the stent, may enable a resilient element to expand the stent.
  • shape memory materials is employed in constructing the stent. A shape memory material may be deformed.
  • a triggering stimulus for example, heat or a magnetic field
  • the material reverts to its original shape.
  • a triggering stimulus for example, heat or a magnetic field
  • Dotter in US 4,503,569 describes a stent that is shaped in the form of a helically wound coil and is constructed out of a shape memory alloy.
  • the stent is initially fashioned in an expanded state. Prior to implantation, the coil is then wound more tightly in order to reduce its diameter.
  • the temperature of the stent is raised to a transition temperature of the shape memory alloy.
  • a heated fluid may be injected into a blood vessel into which the stent was implanted. Upon heating to the transition temperature, the shape memory alloy coil reverts to its original shape, with a larger diameter.
  • the stents described above may expand from their contracted states to their expanded states in a relatively short period of time, for example within a few seconds. Rapid expansion of a stent within a lumen such as a blood vessel may cause trauma to the lumen or to tissue surrounding the lumen. For example, smooth muscle cells lining a blood vessel in which a stent is rapidly expanding may tend to resist an abrupt enlargement of the blood vessel. Inability of the walls of the blood vessel to rapidly acclimatize to the rapidly expanding diameter of the vessel may lead to, or aggravate, damage to the wall of the vessel. Such damage may lead to, or accelerate, re-occlusion or restenosis of the blood vessel. Restenosis of the vessel may require performance of an additional invasive intervention in the treated area within a relatively short period of time.
  • an expandable stent that includes a generally tubular structure made of a plurality of separately expandable elements, the elements arranged such that expansion of an element of the separately expandable elements incrementally expands a transverse dimension of the stent.
  • an element of the separately expandable elements includes a resilient member and a biodegradable restrainer for restraining the resilient member in a bent state.
  • the biodegradable restrainer includes polymers of lactones.
  • an element of the separately expandable elements comprises shape memory alloy.
  • the shape memory alloy is temperature activated.
  • the shape memory alloy is magnetically activated.
  • an element of the separately expandable elements includes piezoelectric actuators.
  • an element of the separately expandable elements includes magnetic actuators.
  • the stent is drug eluting.
  • a method for enlarging a lumen includes providing an expandable stent with a generally tubular structure made of a plurality of separately expandable elements, the elements arranged such that expansion of an element of the separately expandable elements incrementally expands a transverse dimension of the stent.
  • the method further includes inserting the expandable stent in a contracted state into the lumen and delivering the expandable stent to a target location.
  • the method further includes separately causing the elements to incrementally expand a transverse dimension of the stent.
  • an element of the separately expandable elements includes a resilient member and a biodegradable restrainer for restraining the resilient member in a bent state.
  • the biodegradable restrainer comprises polymers of lactones.
  • an element of the separately expandable elements comprises shape memory alloy.
  • the method further includes activating the shape memory alloy by heating the element.
  • the method further includes magnetically causing the element to expand.
  • the method further includes piezoelectrically causing the element to expand.
  • the stent is drug eluting.
  • FIG. 1 is a side view of a stent in a contracted state, in accordance with embodiments of the present invention.
  • Fig. 2 shows the stent shown in Fig. 1 after an initial expansion.
  • Fig. 3 shows the stent of Fig. 2 after degradation of biodegradable restraining elements.
  • Fig. 4 shows the stent of Fig. 3 after folded beams of shape memory alloy have reverted to their unfolded state.
  • Fig. 5 illustrates a method for enlarging a lumen in accordance with embodiments of the present invention.
  • a stent in accordance with embodiments of the present invention is designed to expand from a collapsed or contracted state to an expanded state in a gradual manner.
  • the stent includes a generally tubular structure. During expansion of the stent, the diameter or other transverse dimension of the stent is increased.
  • the stent while in a contracted state, may be inserted into a lumen of a patient's body, for example, the lumen of a blood vessel.
  • a contracted stent may be inserted into the lumen using a catheter.
  • the stent may be enlarged or expanded in stages to an expanded state. For example, expanding the stent within a lumen may restore an open pathway in a lumen of a body conduit, such as a blood vessel, in which stenosis or occlusion has occurred. When remaining in the lumen, the stent may assist in maintaining the opening of the lumen.
  • a body conduit such as a blood vessel
  • An initial expansion of the stent may be performed to enlarge the stent to a partially expanded state.
  • the initial expansion may be performed soon after insertion of the stent into a lumen in order to anchor the stent in place.
  • the stent may be provided with standard plastic or resilient elements.
  • the stent may be partially expanded by plastically deforming the elements using a conventional angioplasty balloon system. If, for example, the stent is provided with flexed resilient elements, the initial expansion may be performed by removing a restraining sheath from around the stent.
  • the stent may be gradually enlarged to an expanded state of the stent.
  • the stent may gradually release into the lumen a drug or other substance that had been adsorbed or otherwise incorporated into the stent, in a manner similar to drug eluting stents known in the art.
  • a stent in accordance with embodiments of the present invention is provided with structural elements that enable gradual expansion of the stent.
  • Each of the elements may be expanded individually, separately and independently of the other elements. Separate expansion of an individual element may cause incremental expansion of the stent.
  • the stent may be provided with elements that interact with an expected environment within a lumen so as to enable expansion of the stent.
  • the stent may be provided with one or more resilient structural elements.
  • Each resilient element may be held in a compressed state by a restraining device constructed using a biodegradable material. Exposure to an environment inside a lumen may cause the biodegradable restraining device to fully or partially dissolve or degrade. When the biodegradable restraining device degrades, the previously restrained resilient element may expand, thus further incrementally enlarging the size of the stent.
  • Several such sets of resilient elements and biodegradable restraining devices may be provided. Each restraining element may be designed to degrade at a rate that may vary from element to element. In this manner, each restrained resilient element may expand separately, thus enlarging the stent gradually.
  • the expansion may take place in response to exposure of a periodically applied trigger or stimulus.
  • An applied stimulus may include, for example, heat, electromagnetic fields or radiation, or ultrasonic waves.
  • the applied stimulus may interact with one or more components of the stent to cause controlled expansion of that component. Expansion of the component may enlarge the stent.
  • the interacting components may include, for example, components made of shape memory alloy, magnetic actuators, or piezoelectric actuators.
  • the application of the stimulus may be controlled so as to enlarge the stent at a sufficiently gradual rate so as to avoid or minimize damage to the wall of the lumen. For example, a period of time over with the expansion may take place may range from several hours to several months.
  • Gradual expansion of the stent may reduce or prevent trauma to the walls of a lumen inside which the stent was implanted. Gradual expansion of the stent, causing gradual enlargement of the lumen, may allow the walls of the lumen to gradually acclimatize to its slowly expanding diameter. Such gradual acclimatization may result in a reduced rate of re-occlusion or restenosis of the lumen.
  • Fig. 1 is a side view of a stent in a contracted state, in accordance with embodiments of the present invention.
  • Stent 10 may represent an entire stent or a longitudinal section of a longer stent.
  • Stent 10 includes one or more elastic assemblies 12.
  • stent 10 may optionally include one or more structural members 14 that may retain an approximately fixed shape during expansion of stent 10.
  • Fixed structural members 14 and elastic assemblies 12 are arranged about a hollow central cavity 16 surrounding, and possibly coaxial with, stent longitudinal axis 15.
  • Central cavity 16 may be approximately cylindrical in shape, with a circular, elliptical, or other suitably shaped cross section.
  • Central cavity 16 may be bent with a longitudinal curvature. As stent 10 expands from a contracted state to an expanded state, the diameter, or other suitable transverse dimension specifying the width of central cavity 16, is increased.
  • Each elastic assembly 12 may include one or more plastic or resilient deformable elements 18.
  • Plastic and resilient elements of stents are known in the art.
  • a plastic element may be deformed from one shape to another when a suitable force is applied.
  • a standard angioplasty balloon may be inflated inside central cavity 16 of stent 10. Inflating the balloon inside central cavity 16 may apply a radial outward force on elastic assembly 12.
  • the outward force applied to elastic assembly 12 may cause a plastic deformable element of elastic assembly 12 to alter its shape from a collapsed or folded configuration to an opened or unfolded configuration. Altering the shape of the plastic deformable element may cause stent 10 to partially expand.
  • a resilient deformable element in elastic assembly 12 may be in a compressed, bent, or folded stressed state when stent 10 is in its contracted state. Thus, removing a compressing restraint may enable the bent resilient deformable element to revert to an unstressed state.
  • the bent or folded elements may expand, partially expanding stent 10.
  • stent 10 may be initially inserted into a lumen while sheathed in a sleeve or sheath. The sheath may apply an inward force on stent 10 that resists the tendency of a resilient element to expand stent 10. After insertion of stent 10 into a lumen, the sheath may be withdrawn from around stent 19. Withdrawing the sheath may enable the resilient deformable element to revert to an unstressed state. Thus, withdrawing the sheath may enable stent 10 to partially expand.
  • Fig. 2 shows the stent shown in Fig. 1 after an initial expansion.
  • one or more of deformable elements 18 may include a plastic element that is unfolded during initial expansion by means of application of an outward force, such as by inflating a balloon in central cavity 16.
  • one or more of deformable elements 18 may include a resilient element that reverts to an unfolded state during initial expansion when a restraining element, such as a sheath, was removed from around stent 10.
  • gradual expansion elements 20 remain folded.
  • One or more of gradual expansion elements 20 may be designed to expand sequentially at a time after the initial expansion.
  • one or more of gradual expansion elements 20 may include a resilient element that is restrained from expanding by means of a restraining or encapsulating element, or restrainer, such as a thread, film, tape, sheath, or adhesive layer.
  • the restrainer is at partially constructed of a biodegradable material.
  • the material may preferably be biocompatible.
  • the biodegradable material is designed to dissolve, become absorbed, or otherwise degrade under long-term exposure to suitable conditions. Such conditions may include the conditions commonly found within a lumen within which stent 10 is implanted. Such materials are described by, for example, Pitt et al. in US 4,379,138 and Buscemi et al.
  • Fig. 3 shows the stent of Fig. 2 after degradation of biodegradable restraining elements. Gradual expansion elements 20 have been expanded.
  • one or more of gradual expansion elements 20, for example those labeled 20a may be at least partially constructed of shape memory alloy.
  • the shape memory alloy may preferably be biocompatible.
  • An example of a biocompatible shape memory alloy is nickel-titanium alloy.
  • each shape memory element 20a may have been folded when its temperature was below a transition temperature of the shape memory alloy. Activating a shape memory element 20a by heating it to its transition temperature may restore shape memory element 20a to its unfolded, expanded state. Selective activation of individual shape memory elements 20a may cause selective expansion of the heated shape memory elements 20a.
  • stent 10 may cause stent 10 to expand gradually at a controlled rate.
  • an individual shape memory element 20a may be heated by directing energy, such as focused electromagnetic radiation or ultrasound waves, on a single shape memory element 20a.
  • Fig. 4 shows the stent of Fig. 3 after folded beams of shape memory alloy have reverted to their unfolded state.
  • shape memory element 20a has reverted to a straightened shape that does not include any bends or folds.
  • Such a straightened shape may provide additional structural strength to stent 10.
  • additional structural strength provided by straightened shape memory element 20a may resist inward pressure exerted by walls of a lumen in which stent 10 is implanted.
  • shape memory elements 20a may include a magnetically activated material such as a shape memory alloy that reverts to its original shape when exposed to a magnetic field. Selective application of a suitable magnetic field to a magnetically activated shape memory element 20a may expand the element, causing controlled expansion of stent 10.
  • expansion elements may include piezoelectric actuators that move in response to an introduced or induced electric current. Selective induction or introduction of an appropriate electric current in the actuator may cause controlled expansion of the stent.
  • Complete expansion of all gradual expansion elements in the stent may expand the stent to its fully expanded state.
  • a stent intended for implantation in a blood vessel may expand from a diameter of about 1.6 mm in its contracted state, to a diameter of about 5 mm in its fully expanded state.
  • FIG. 5 illustrates a method for enlarging a lumen in accordance with embodiments of the present invention.
  • a lumen enlargement method in accordance with embodiments of the present invention includes implanting a gradually expandable stent into the lumen and gradually expanding the stent.
  • a gradually expandable stent may be inserted into a lumen, such as a blood vessel (step 30).
  • a lumen such as a blood vessel
  • an end of a catheter may be inserted into the lumen, and the stent may be inserted into the lumen via the catheter.
  • the stent may then be guided to a target location within the lumen (step 32).
  • Initial expansion of the stent may then be performed, in a manner depending on the structure of the stent (step 34).
  • a balloon may be inflated within the stent in order to perform the initial expansion, or a restraining element such as a sheath may be removed from the stent, enabling an elastic restoring force to initially expand the stent.
  • the stent may then remain within the lumen for an extended period of time. During this time, the stent is expanded gradually.
  • biodegradable restrainers may degrade and enable elastic restoring forces of elastic elements to gradually expand the stent.
  • a stimulus or other activation process may be applied selectively to individual sections of the stent, separately of other sections, at predetermined times.
  • electromagnetic radiation or ultrasound waves may be focused on a section of the stent to cause the section to enlarge the stent.
  • Selective sequential activation of individual sections of the stent at predetermined times may cause the stent to expand gradually. Gradual expansion of the stent may enlarge the lumen (step 36).

Abstract

Cette invention concerne une endoprothèse extensible comprenant une structure généralement tubulaire faite de plusieurs éléments séparément extensibles. Les éléments sont disposés de manière telle que la dilatation de l’un des éléments séparément extensibles dilate par palier une dimension transversale de l’endoprothèse.
PCT/IL2009/000305 2008-03-18 2009-03-18 Endoprothèse à dilatation progressive WO2009116040A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US6973008P 2008-03-18 2008-03-18
US61/069,730 2008-03-18

Publications (2)

Publication Number Publication Date
WO2009116040A2 true WO2009116040A2 (fr) 2009-09-24
WO2009116040A3 WO2009116040A3 (fr) 2010-03-11

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PCT/IL2009/000305 WO2009116040A2 (fr) 2008-03-18 2009-03-18 Endoprothèse à dilatation progressive

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021231364A1 (fr) * 2020-05-11 2021-11-18 Subroto Paul Stent amovible

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5545210A (en) * 1994-09-22 1996-08-13 Advanced Coronary Technology, Inc. Method of implanting a permanent shape memory alloy stent
US20070083258A1 (en) * 2005-10-06 2007-04-12 Robert Falotico Intraluminal device and therapeutic agent combination for treating aneurysmal disease
US20080004528A1 (en) * 2006-01-25 2008-01-03 Fitzsimons Thomas P Ultrasound medical system and methods

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5545210A (en) * 1994-09-22 1996-08-13 Advanced Coronary Technology, Inc. Method of implanting a permanent shape memory alloy stent
US20070083258A1 (en) * 2005-10-06 2007-04-12 Robert Falotico Intraluminal device and therapeutic agent combination for treating aneurysmal disease
US20080004528A1 (en) * 2006-01-25 2008-01-03 Fitzsimons Thomas P Ultrasound medical system and methods

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021231364A1 (fr) * 2020-05-11 2021-11-18 Subroto Paul Stent amovible

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