WO2025019488A1 - Stent with anti-occlusion system - Google Patents
Stent with anti-occlusion system Download PDFInfo
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- WO2025019488A1 WO2025019488A1 PCT/US2024/038197 US2024038197W WO2025019488A1 WO 2025019488 A1 WO2025019488 A1 WO 2025019488A1 US 2024038197 W US2024038197 W US 2024038197W WO 2025019488 A1 WO2025019488 A1 WO 2025019488A1
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- stent
- coating
- magnetic components
- magnetic
- tubular member
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Classifications
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- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2002/041—Bile ducts
-
- 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
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/001—Figure-8-shaped, e.g. hourglass-shaped
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0069—Three-dimensional shapes cylindrical
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
-
- 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
- A61F2250/0001—Means for transferring electromagnetic energy to implants
-
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
-
- 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
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/04—Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/08—Coatings comprising two or more layers
Definitions
- the present disclosure pertains to medical devices, methods for manufacturing medical devices, and uses thereof. More particularly, the present disclosure pertains to an anti-occlusion stent for implantation in a body lumen, and associated methods.
- Implantable stents are devices that are placed in a body lumen, such as the esophageal tract, the gastrointestinal tract (including the intestine, stomach and the colon), tracheobronchial tract, urinary tract, biliary tract, vascular system, etc. to provide support and to maintain the body lumen open.
- a body lumen such as the esophageal tract, the gastrointestinal tract (including the intestine, stomach and the colon), tracheobronchial tract, urinary tract, biliary tract, vascular system, etc.
- These stents are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods.
- stents delivery systems, and methods, each has certain advantages and disadvantages. For example, some stents may become occluded.
- Occlusive events can be a combination of local factors, such as, but not limited to inadequate stricture resolution and irregular bile properties and/or related to stent design, such as, but not limited to, coating tackiness and/or an interaction between the wire and bile.
- stent design such as, but not limited to, coating tackiness and/or an interaction between the wire and bile.
- a stent may comprise an elongated tubular member comprising at least one strut forming a tubular wall having a plurality of cells extending through a thickness of the tubular wall, the elongated tubular member configured to move between a radially collapsed configuration and a radially expanded configuration, a coating Atty. Docket No.2001.3238111 disposed on the elongated tubular member and spanning at least some of the plurality of cells, and one or more magnetic components disposed on or within the coating.
- the coating may comprise an inner layer and an outer layer.
- the one or more magnetic components may be disposed between the inner layer and the outer layer of the coating.
- the one or more magnetic components may be discrete elements disposed within at least some of the plurality of cells.
- the one or more magnetic components may be elongate strips extending over the at least one strut.
- the one or more magnetic components may be spaced along a length of the elongated tubular member.
- the one or more magnetic components may be spaced about a circumference of the elongated tubular member.
- the coating may form a pocket within at least some of the plurality of cells.
- the coating may extend from a proximal end to a distal end of the elongated tubular member.
- the coating may cover less than an entirety of the elongated tubular member.
- At least one of the one or more magnetic components may be positioned adjacent to a coating-free region of the elongated tubular member.
- the one or more magnetic components may comprise a silicone base and a magnetic material.
- the magnetic material may comprise carbonyl iron. Atty. Docket No.2001.3238111
- the one or more magnetic components in response to an applied magnetic field, may be configured to move radially inward and/or radially outward.
- the applied magnetic field may be a pulsed magnetic field or an alternating magnetic field.
- a stent may comprise an elongated tubular member comprising at least one strut forming a tubular wall having a plurality of cells extending through a thickness of the tubular wall, the elongated tubular member configured to move between a radially collapsed configuration and a radially expanded configuration, a coating disposed on the elongated tubular member and spanning at least some of the plurality of cells, and a plurality of magnetic components embedded within the coating, the plurality of magnetic components including a silicone base and carbonyl iron.
- a method for preventing occlusion of a stent may comprise delivering a stent to a target location within a body.
- the stent may comprise an elongated tubular member comprising at least one strut forming a tubular wall having a plurality of cells extending through a thickness of the tubular wall, the elongated tubular member configured to move between a radially collapsed configuration and a radially expanded configuration, a coating disposed on the elongated tubular member and spanning at least some of the plurality of cells, and one or more magnetic components disposed on or within the coating.
- the method may further comprise positioning a console configured to supply a magnetic field exterior to the body and adjacent to the target location and periodically activating the magnetic field.
- the one or more magnetic components may be configured to move radially inward and/or radially outward relative to the at least one strut.
- the magnetic field may be a pulsed magnetic field.
- the magnetic field may be an alternating magnetic field.
- the console may be configured to be releasably secured about the body.
- FIG.1 is a side view of an illustrative endoluminal implant or stent
- FIG.2A is a partial perspective view of the illustrative stent of FIG.1
- FIG.2B is a partial side view of the illustrative stent of FIG.1
- FIG.3 is a schematic cross-sectional view of the illustrative stent, taken at line 3-3 of FIG.2B
- FIGS.4A-4H are side views of the illustrative stent having magnetic components arranged in different regular or irregular arrangements
- FIG.5A is a partial side view of an illustrative stent including magnetic components prior to magnetization
- FIG.5B is a partial side view of the illustrative stent of FIG.5A including magnetic components after magnetization
- FIG.6 is a schematic view of the illustrative stent
- an endoluminal implant, or stent that can deliver luminal patency within the pancreaticobiliary tree of a patient.
- the relatively narrow biliary tract ducts consist of a series of bifurcations linking the liver, gallbladder, and pancreas via the papilla to the duodenal space for the transportation of bile and related enzymic substances for many metabolic functions but most commonly the body’s ability to digest and absorb fats and vitamins D and K.
- blockages may occur in the pancreaticobiliary tree due to tumor related duct narrowing, stricture formation, infections, or stone and sludge generation among other etiologies.
- Endoscopic retrograde cholangiopancreatography is used to diagnose and treat these duct Atty. Docket No.2001.3238111 narrowings, regardless of the malignant or benign nature of the disease.
- SEMS self-expanding metal stent
- occlusions may occur within the stent after stent placement. Occlusive events can be a combination of local factors such as, but not limited to, inadequate stricture resolution and/or irregular bile properties.
- Occlusion can also be related to stent design components such as, but not limited to, coating tackiness and/or an interaction between the wire of the stent and bile (both causing drag and pooling of bile which accumulates over a time course). Due to the remote nature of a placed SEMS, the ability to diagnose and interact with a potential occlusive event is limited and typically can only be resolved through intervention at a stage when the occlusive event has demonstrated an exacerbation of a patient’s symptoms (e.g., jaundice, abdominal pain, etc.).
- Occlusion may result in increased procedural charges due to reintervention and stent replacement, patient discomfort even though the stent device itself may be functioning effectively as a scaffold, retarding of the vessel, and/or an unjustified reputation for particular device families as being less efficacious or brands spurned due to historical or anecdotal knowledge of occlusive or suggestive occlusive events.
- the present disclosure is directed towards alternative stent designs which offer opportunities for prophylactic or preventative intervention to delay occlusive events or potential occlusive sources without repeated surgical intervention increasing stent efficacy during the procedural timespan.
- FIG.1 illustrates a side view of an illustrative endoluminal implant 10, such as, but not limited to, a stent.
- the stent 10 may be formed from an elongated tubular member 12. While the stent 10 is described as generally tubular, it is contemplated that the stent 10 may take any cross-sectional shape desired.
- the stent 10 may have a first, or proximal end 14, a second, or distal end 16, and an intermediate region 18 disposed between the first end 14 and the second end 16.
- the stent 10 may include a lumen 32 extending from a first opening adjacent the first end 14 to a second opening adjacent to the second end 16 to allow for the passage of food, fluids, etc. Atty.
- the stent 10 may be expandable from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration. In some cases, the stent 10 may be deployed to a configuration between the collapsed configuration and a fully expanded configuration.
- the stent 10 may be structured to extend across a stricture and to apply a radially outward pressure to the stricture in a lumen to open the lumen and allow for the passage of substances.
- the proximal end 14 of the stent 10 may include a plurality of loops 38.
- the loops 38 may be configured to receive a retrieval tether or suture (not explicitly shown) interwoven therethrough, or otherwise passing through one or more of the loops 38.
- the retrieval suture may be used to collapse and retrieve the stent 10, if so desired.
- the retrieval suture may be pulled like a drawstring to radially collapse the proximal end 14 of the stent 10 to facilitate removal of the stent 10 from a body lumen.
- the stent 10 may have a woven structure, fabricated from a number of filaments or struts 36 forming a tubular wall.
- the stent 10 may be knitted or braided with a single filament or strut interwoven with itself and defining open cells 46 extending through the thickness of the tubular wall of the stent 10.
- the stent 10 may be braided with several filaments or struts interwoven together and defining open cells 46 extending along a length and around the circumference of the tubular wall of the stent 10.
- the open cells 46 may each define an opening from an outer surface of the tubular wall to an inner surface of the tubular wall (e.g., through a thickness thereof) that is free from the filaments or struts 36.
- Some exemplary stents including braided filaments include the WallFlex®, WALLSTENT®, and Polyflex® stents, made and distributed by Boston Scientific, Corporation.
- the stent 10 may be knitted, such as the UltraflexTM stents made by Boston Scientific, Corporation.
- the stent 10 may be of a knotted type, such the Precision ColonicTM stents made by Boston Scientific, Corporation.
- the stent 10 may be a laser cut tubular member, such as the EPICTM stents made by Boston Scientific, Corporation.
- a laser cut tubular member may have an open and/or closed cell geometry including one or more interconnected monolithic filaments or struts defining open cells 46 therebetween, with the open cells 46 extending along a length and around the circumference of the tubular wall.
- the open cells 46 may each define an opening from an outer surface of the tubular wall to an inner surface of the tubular wall (e.g., through a thickness thereof) that is free from the interconnected monolithic Atty.
- an inner and/or outer surface of the tubular wall of the stent 10 may be entirely, substantially, or partially, covered with a polymeric covering or coating 40, as will be described in more detail herein.
- the covering or coating 40 may extend across and/or occlude one or more, or a plurality of the cells 46 defined by the struts or filaments 36.
- the stent 10 may be a self-expanding stent (SES), although this is not required.
- the stent 10 in the radially expanded configuration, the stent 10 may include a first end region 20 proximate the proximal end 14 and a second end region 22 proximate the second end 16.
- the first end region 20 and the second end region 22 may include retention features or anti-migration flared regions 24, 26 having enlarged diameters relative to the intermediate portion 18.
- the anti-migration flared regions 24, 26, which may be positioned adjacent to the first end 14 and the second end 16 of the stent 10, may be configured to engage an interior portion of the walls of the body lumen.
- the retention features, or flared regions 24, 26 may have a larger diameter than the cylindrical intermediate region 18 of the stent 10 to prevent the stent 10 from migrating once placed in the body lumen.
- the transition 28, 30 from the cross-sectional area of the intermediate region 18 to the retention features or flared regions 24, 26 may be gradual, sloped, or occur in an abrupt step-wise manner, as desired.
- the first anti-migration flared region 24 may have a first outer diameter and the second anti-migration flared region 26 may have a second outer diameter.
- the first and second outer diameters may be approximately the same, while in other instances, the first and second outer diameters may be different.
- the stent 10 may include only one or none of the anti-migration flared regions 24, 26.
- the first end region 20 may include an anti-migration flare 24 while the second end region 22 may have an outer diameter similar to the intermediate region 18.
- the second end region 22 may include an anti-migration flare 26 while the first end region 20 may have an outer diameter similar to an outer diameter of the intermediate region 18.
- the stent 10 may have a uniform outer diameter from the first end 14 to the second end 16. It is contemplated that the outer diameter of the stent 10 may be varied to suit the desired application.
- the elongated tubular member of the stent 10 can be made from a number of different materials such as, but not limited to, metals, metal alloys, Atty. Docket No.2001.3238111 shape memory alloys, and/or polymers, as desired, enabling the stent 10 to be expanded into shape when accurately positioned within the body.
- the material may be selected to enable the stent 10 to be removed with relative ease as well.
- the elongated tubular member of the stent 10 can be formed from alloys such as, but not limited to, nitinol and Elgiloy®.
- the stent 10 may be self-expanding or require an external force to expand the stent 10.
- composite filaments may be used to make the stent 10, which may include, for example, an outer shell or cladding made of nitinol and a core formed of platinum or other radiopaque material.
- the elongated tubular member of the stent 10 may be formed from polymers including, but not limited to, polyethylene terephthalate (PET).
- PET polyethylene terephthalate
- the filaments of the stent 10, or portions thereof may be bioabsorbable or biodegradable, while in other instances the filaments of the stent 10, or portions thereof, may be biostable.
- FIG.2A illustrates a partial perspective view of the illustrative stent 10 of FIG.1
- FIG.2B illustrates a partial side view of the illustrative stent 10 of FIG.1.
- the inner and/or outer surface of the tubular wall of the stent 10 may be entirely, substantially, or partially covered with a polymeric covering or coating 40.
- the coating 40 may be silicone, polyurethane, or other flexible polymeric material.
- the coating 40 may be applied such that there is an excess of material or a pocket of material 44 extending between the struts 36.
- the coating 40 may be loose and extend radially inward from the struts 36 for a radial distance or height 42 to form a void.
- the coating 40 may be generally taut and extend in the same plane as the struts 36. While FIGS.2A and 2B illustrate the pockets 44 as extending radially inward, it is contemplated that the pockets 44 may extend radially outward from the struts 36 for a radial distance or height.
- the pocket 44 may have a generally truncated pyramidal shape with four flat converging (e.g., angled) side walls 48a, 48b, 48c, 48d and a flat bottom or base wall 48e. While the pocket 44 is generally illustrated as having a cross-section in the shape of a rhombus similar to a diamond shape of the cells 46 formed by the struts 36, the pocket 44 may take any shape desired. For instance, in some instances the pocket 44 may have a base wall 48e having a generally arcuate shape, such as a generally spherical shape with a spherically concave radially outward facing surface and a spherically convex radially inwardly facing surface.
- the pocket 44 may form a void 50 between a radially outward surface (e.g., a base surface) of the pocket 44 and the Atty. Docket No.2001.3238111 circumference of the tubular wall of the stent 10 formed by the struts 36.
- the void 50 may be radially outward of the tubular wall of the stent 10.
- the pockets 44 may be formed using a mandrel and/or mold.
- a mandrel may be formed having protrusions or recesses of the desired size and shape of the pockets 44.
- the struts 36 may be wound, braided, woven, or otherwise disposed about the mandrel with the cells of the tubular wall aligned with the protrusions or recesses.
- a sleeve made of, for example, silicone or other polymer material may be disposed over the mandrel and struts 36. The sleeve may be heated or otherwise molded to the shape of the mandrel to form the coated stent 10 including the pockets 44 between the struts 36.
- a polymeric material may be spray or dip coated onto the mandrel and struts 36 such that the polymeric material flows over the protrusions and/or into the recesses of the mandrel.
- the pockets 44 may further include a magnetic component 52 such that the stent 10 includes at least one or more magnetic components 52.
- the magnetic components 52 may be secured to the coating, such as in the pockets 44, while the magnetic components 52 are spaced away from and /or not in direct contact with the struts 36 of the stent 10.
- the magnetic components 52 may be positioned which the cells 46 between adjacent filaments or struts 36 of the stent 10 while not directly contacting the filaments or struts 36 forming the scaffold structure of the stent 10.
- the magnetic component 52 may be encapsulated between an inner layer 40a and an outer layer 40b of the coating 40. However, this is not required. In some cases, the magnetic component 52 may be on an inner surface of the inner layer 40a or an outer surface of the outer layer 40b of the coating 40.
- an inner and/or outer surface of the scaffold structure of the stent 10 may be entirely, substantially or partially, covered with a polymeric covering or layer 40.
- a covering or coating 40 may extend across the open cells 46 of the scaffold structure to prevent tissue ingrowth into the lumen of the stent 10.
- one or both of the polymeric coverings 40a, 40b may be omitted.
- the stent 10 may include only the outer polymeric covering 40b on an outer surface of the scaffold structure.
- the stent 10 may include only the inner polymeric covering 40a on an inner surface of the scaffold structure.
- the inner layer 40a and the outer layer 40b may be formed as a single unitary structure. In other embodiments, the inner layer 40a and the outer layer 40b may be formed as separate layers.
- the longitudinal arrays may be evenly or eccentrically spaced about a circumference of the stent 10 and may be spaced about an entirety of the circumference or less than an entirety of the circumference of the stent 10. Further, the stent 10 may include only a single array or more than one array of magnetic components 52, as desired.
- the longitudinally extending arrays may extend Atty. Docket No.2001.3238111 along an entirety of a length of the stent 10 or less than an entirety of the length of the stent 10, as desired.
- the longitudinal arrays need not extend continuously along a length of the stent 10. For example, the arrays may include a gap or space therein. Further, in some embodiments, the magnetic components 52 may not be confined to being positioned within the openings 46.
- the magnetic components 52 may be positioned over and/or under one or more struts 36.
- the magnetic components 52 may be arranged as one or more longitudinally extending magnetic components 52, as shown in FIG.4C.
- the longitudinally extending magnetic components 52 may be evenly or eccentrically spaced about a circumference of the stent 10 and may be spaced about an entirety of the circumference or less than an entirety of the circumference of the stent 10.
- the stent 10 may include only a single longitudinally extending magnetic component 52 or more than one longitudinally extending magnetic components 52, as desired.
- the longitudinally extending magnetic components 52 may extend along an entirety of a length of the stent 10 or less than an entirety of the length of the stent 10, as desired.
- the longitudinally extending magnetic components 52 need not extend continuously along a length of the stent 10.
- the longitudinally extending magnetic components 52 may include gaps or spaces therein.
- the magnetic components 52 may be arranged in one or more circumferential arrays, as shown in FIG.4D.
- the circumferential arrays may be evenly or eccentrically spaced about a length of the stent 10 and may be spaced about an entirety of the length or less than an entirety of the length of the stent 10.
- the stent 10 may include only a single array or more than one array of magnetic components 52, as desired.
- the circumferentially extending arrays may extend about an entirety of a circumference of the stent 10 or less than an entirety of the circumference of the stent 10, as desired.
- the circumferentially extending arrays need not extend continuously along a circumference of the stent 10.
- the circumferentially extending arrays may include gaps or spaces therein.
- the magnetic components 52 may be arranged as one or more circumferentially extending magnetic components 52, as shown in FIG.4E.
- the circumferentially extending magnetic components 52 may be evenly or eccentrically spaced about a length of the stent 10 and may be spaced about an entirety of the length or less than an entirety of the length of the stent 10.
- the stent 10 may include only a single circumferentially extending magnetic component 52 or more than one circumferentially extending magnetic components 52, as desired.
- the circumferentially extending magnetic components 52 may extend about an entirety of a circumference of Atty. Docket No.2001.3238111 the stent 10 or less than an entirety of the circumference of the stent 10, as desired.
- the circumferentially extending magnetic components 52 need not extend continuously along a circumference of the stent 10.
- the circumferentially extending magnetic components 52 may include gaps or spaces therein.
- the magnetic components 52 may be arranged in one or more helical arrays, as shown in FIG.4F.
- the helical arrays may be evenly or eccentrically spaced about a length of the stent 10 and may be spaced or extend along an entirety of the length and/or circumference or less than an entirety of the length and/or circumference of the stent 10.
- the stent 10 may include only a single array or more than one array of magnetic components 52, as desired.
- the helically extending arrays need not extend continuously along a length and/or circumference of the stent 10.
- the helically extending arrays may include gaps or spaces therein.
- the magnetic components 52 may be arranged as one or more helically extending magnetic components 52, as shown in FIG.4G.
- the helically extending magnetic component 52 may be evenly or eccentrically spaced about a length of the stent 10 and may be spaced or extend along an entirety of the length and/or circumference or less than an entirety of the length and/or circumference of the stent 10. Further, the stent 10 may include only a single helically extending magnetic component 52 or more than one helically extending magnetic components 52, as desired. The helically extending magnetic components 52 need not extend continuously along a length and/or circumference of the stent 10. For example, the helically extending magnetic components 52 may include gaps or spaces therein.
- the magnetic components 52 may be clustered at the proximal end 14 of the stent 10 and/or at the distal end 16 of the stent 10 while the intermediate region 18 is free from magnetic components 52, as shown in FIG.4H.
- the intermediate region 18 may include magnetic components 52 while the proximal end 14 and/or distal end 16 of the stent 10 are free from magnetic components 52.
- the magnetic components 52 may be arranged in any arrangement, regular or irregular, as desired.
- FIGS.4A-4H generally illustrate the magnetic components 52 as discrete elements within the openings 46 between struts 36 or as elongate strips, in some cases, the magnetic components 52 may be incorporated into an entirety of the coating 40 or selected regions thereof. It is further contemplated that the stent 10 may include the magnetic components 52 as any Atty. Docket No.2001.3238111 combination of discrete elements within the openings 46, elongate strips extending over at least one strut 36, and/or incorporated into an entirety or region of the coating 40.
- the magnetic components 52 may be a colloid, such as, but not limited to, a silicone base having a quantity of ferromagnetic material, or other magnetic material, mixed therein.
- the ferromagnetic material may be carbonyl iron powder.
- Other ferromagnetic materials may include, but are not limited to, iron, cobalt nickel, rare-earth metals, and/or alloys or compounds thereof. It is contemplated that other types of magnetic materials may also be used, such as, but not limited to, ferrimagnetic, etc.
- the colloid may be combined using a standard mixing process. Carbonyl iron powder is available with filings of different lengths and densities which can be added to the silicone base to tailor the magnetic properties of the magnetic components 52. It is contemplated that the colloid coating may be applied via dip coating, spray coating, or can be manually applied in a sleeve form.
- the variety of coating techniques may allow the magnetic components 52 to be applied to very specific areas of the stent 10 in any pattern desired to achieve a desired effect. It is further contemplated that the mechanical properties of the stent 10 may be tailored or customized by using coating materials having different or varying mechanical attributes (such as, but not limited to, various silicones) to achieve a desired effect. In one illustrative example, a silicone with higher elasticity and greater flexibility may be used for stents indicted for use in a more tortuous region of the body. This is just one example. Generally, upon the application of a magnetic field, the magnetic components 52 may be moved radially outward or radially inward relative to the stent framework (e.g., struts 36).
- the stent framework e.g., struts 36
- each magnetic component 52 may be localized within the cell spaces 46, if provided as discrete elements within the openings 46.
- the magnetic components 52 may move radially inward and/or outward but may not move circumferentially and/or longitudinally.
- Atty. Docket No.2001.3238111 The magnetic components 52 may be selectively exposed to a magnetic field to move the coating 40 of the stent 10.
- a localized magnetic field may be generated by a bespoke or custom mobile console configured to be positioned exterior to the patient. The console may create an alternating magnetic field which generates an oscillating attraction and repulsion of the magnetic components 52 embedded in the coating 40 of the stent 10.
- FIGS.5A illustrates a partial side view of an illustrative stent 10 including magnetic components 52 prior to magnetization
- FIG.5B illustrates a partial side view of the illustrative stent 10 of FIG.5A including magnetic components 52 after magnetization.
- the magnetic components 52 have been applied to specific areas of the stent 10. For example, the magnetic components 52 do not cover or extend over an entirety of the stent 10.
- magnetization causes to the magnetic components 52 and the coating 40 to move radially outward from the plane of the struts 36 while maintaining each magnetic component 52 within a specific cell region 46. It is contemplated that in the absence of magnetization, the resiliency of the coating 40 may cause the coating 40 to return to the configuration in which the coating 40 is generally in the plane of the struts 36. Alternatively, or additionally, the resiliency of the coating 40 may cause the coating 40 to extend radially inward into the lumen 32 of the stent 10, at least temporarily.
- FIG.6 depicts a schematic view of the illustrative stent 10 deployed within the biliary tree.
- the stent 10 is positioned within a biliary duct 100 and is positioned across a stricture 102.
- the distal end 16 of the stent 10 extends past the papillary mass 104, through the duodenal wall 106 and into the duodenum 108.
- the stent 10 may be positioned within the biliary tree via endoscopic retrograde cholangiopancreatography (ERCP). For example, the stent 10 may be guided to the biliary location and subsequently deployed, as shown in FIG.6.
- the patient may be Atty. Docket No.2001.3238111 discharged with the stent 10 in-situ.
- the patient may be guided through a non-invasive treatment option.
- the stent 10 may be periodically subjected to a magnetic field to cause the magnetic components 52, and the coating 40, to move and dislodge or prevent occlusions within the lumen 32 of the stent 10.
- a magnetic field may vary depending on whether or not the patient is symptomatic (e.g., showing signs of an occlusion) among other factors. In some cases, the time period between applications of the magnetic field may be in the range of minutes, hours, days, weeks, or months. It is further contemplated that the magnetic field may be applied at an outpatient facility, at a step-down facility, or as a home care option with the correct instructions.
- FIG.7 illustrates a schematic view of the illustrative placement of a console 200 for generating a magnetic field relative to the body of the patient 202.
- the console 200 is positioned exterior to the patient 202 adjacent to the desired treatment region.
- the console 200 is positioned adjacent to the biliary tree. It is contemplated that the console 200 may be positioned at any location of the patient 202 to achieve the desired treatment, including, but not limited to the, the anterior side, the posterior side, the left side, or the right side, etc.
- FIG.8 illustrates a perspective view of an illustrative console system 204.
- the console system 204 may be portable and/or wearable such that the user may apply the magnetic field in a clinical setting, at home, or while going about their daily life.
- the console system 204 may include a body portion 206 defining a pocket or recess 208.
- the pocket 208 may be sized and shaped to receive the console 200 therein.
- One or more straps 210a, 210b may extend from the body portion 206.
- the one or more straps 210a, 210b may be configured to be secured about the body of the patient 202 to allow the patient 202 hands free operation of the console 200.
- the length of the straps 210a, 210b may be adjustable to accommodate different body locations and/or different body types.
- the one or more straps 210a, 210b may each include a fastening mechanism 212a, 212b adjacent to the free ends 214a, 214b thereof.
- the fastening mechanisms 212a, 212b may be releasably coupled to one another allow the straps 210a, 210b to be releasably secured about the patient 202.
- Some illustrative fastening mechanisms 212a, 212b may include, but are not limited to, hook and loop fasteners, snap mechanisms, buttons, zippers, etc. Atty. Docket No.2001.3238111 When activated, the console 200 generates a localized magnetic field which may attract and/repel the magnetic components 52 in the stent 10.
- the console 200 may generate an alternating magnetic field which may generate an oscillating attraction and repulsion of the magnetic components 52 embedded in the coating 40 of the stent 10 in a cyclical manner thus causing the coating 40 to move radially outwards and inwards and encouraging sludge material to remain in motion. It is contemplated that the frequency of the oscillations may be adjusted to achieve the desired effect. In another example, a pulsed attractive-to-neutral cyclical field may be applied. In this instance, the magnetic components 52 may not necessarily be magnetically charged in their own aspect.
- the magnetic field may attract the magnetic components 52 in the coating 40 towards the applied source via the console 200 and when the source is removed the magnetic components 52 bounce back into position due to the elasticity of the coating 40, causing the magnetic components 52 and/or coating 40 to overshoot and protrude temporarily into the lumen 32 of the stent 10, thus causing a disruption of the coating 40 and encouraging sludge material to remain in motion.
- the magnetic field oscillating frequency in either the alternating magnetic field or the pulsed magnetic field may be controlled and adjusted via the console 200. For example, the frequency may be increased for a more vigorous movement of the coating 40 of the stent 10 and the frequency may be decreased for a gentler movement of the coating 40 of the stent 10.
- increasing the frequency may increase the radial distance by which the coating 40 of the stent 10 is displaced.
- the movement or vibration of the coating 40 of the stent 10 may encourage internal material, such as, but not limited to, sludge, bile, stone debris, etc., to be keep moving through the lumen 32 of the stent 10 thus preventing or minimizing stagnation and occlusion.
- the movement of the coating 40 may inhibit occlusive precursor materials such as biofilm from gaining adhesion to the surface of the stent 10. It is contemplated that if sludge, bile, stone debris, biofilm, etc., are left undisturbed they may cause early occlusion or other malfunctioning of the stent 10.
- the magnetic field may be selectively applied along the length of the stent 10.
- FIGS.9A-9C illustrate a partial cross-sectional view of the stent 10 as a magnetic field is selectively applied.
- the stent 10 is in an initial state with no magnetic field being applied.
- the inner layer of coating 40a, the outer layer of coating 40b, and the magnetic components 52 each lie within a same plane or generally parallel to a plane of the struts 36.
- a magnetic field has been applied Atty. Docket No.2001.3238111 to a first region 60 of the stent 10 while there is zero or no magnetic field applied to a second region 62 of the stent 10.
- the magnetic components 52 in the first region 60 are drawn radially outward from the initial configuration, as shown in FIG.9B while the magnetic components 52 in the second region 62 remain stationary.
- FIG.9C the magnetic field has been removed from the first region 60 and applied to the second region 62.
- the resiliency of the inner layer 40a and the outer layer 40b may cause the coating 40 and the magnetic components 52 to snap or move radially inwards within the lumen 32 of the stent 10, at least temporarily, as shown in FIG.9C.
- the magnetic components 52 in the second region 62 are drawn radially outward from the initial configuration.
- the magnetic components 52 thereof may move radially inwards.
- the selective activation of the magnetic field over specific region of the stent 10 may allow the coating of the stent 10 to undulate in a wave-like pattern along a length thereof.
- an alternating magnetic field may be used to create a wave like movement along a length of the stent 10.
- an entirety of the stent 10 may be exposed to the magnetic field at a same time.
- the magnetic field may be applied to a region of the stent 10 adjacent to the stricture 102 or other diseased site to pulse the stent 10 at the stricture 102 and thus manipulate the stricture.
- the magnetic components 52 may be distributed about the length and/or circumference of the stent 10 in a number of different arrangements.
- the magnetic components may be arranged to suit a particular condition under treatment or the perceived location of potential occlusion. For example, if an occlusion is predicted to potentially occur higher in the biliary duct (e.g., potentially due to stones, debris, etc.), the magnetic components 52 may be located closer to the proximal end 14 of the stent 10.
- the coating 40 and the magnetic components 52 may cause the tissue ingrowth to be separated from any holes in the coating 40 and allow for easier stent removal.
- a program of magnetic exposure prior to intervention may cause easier stent extraction.
- the magnetic field may be strategically applied to perform remote extraction of the stent 10 with the stent 10 passing through the natural vessel, without inserting additional medical devices into the body.
- the inclusion of a coating 40 including magnetic components 52 with a partially covered (PC) stent may allow for efficient extraction of the stent 10 even given that the partially coated stent is designed for tissue ingrowth.
- FIG.10 illustrates a side view of another illustrative endoluminal implant 300, such as, but not limited to, a stent.
- the stent 300 may be similar in form and function to the stent 10 described herein.
- the stent 300 may be formed from an elongated tubular member 302. While the stent 300 is described as generally tubular, it is contemplated that the stent 300 may take any cross-sectional shape desired.
- the stent 300 may have a first, or proximal end 304, a second, or distal end 306, and an intermediate region 308 disposed between the first end 304 and the second end 306.
- the stent 300 may include a lumen 310 extending from a first opening adjacent the first end 304 to a second opening adjacent to the second end 306 to allow for the passage of food, fluids, etc.
- the stent 300 may be expandable from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration. In some cases, the stent 300 may be deployed to a configuration between the collapsed configuration and a fully Atty. Docket No.2001.3238111 expanded configuration.
- the stent 300 may be structured to extend across a stricture and to apply a radially outward pressure to the stricture in a lumen to open the lumen and allow for the passage of substances.
- the proximal end 304 of the stent 300 may include a plurality of loops 312.
- the loops 312 may be configured to receive a retrieval tether or suture (not explicitly shown) interwoven therethrough, or otherwise passing through one or more of the loops 312.
- the retrieval suture may be used to collapse and retrieve the stent 300, if so desired.
- the retrieval suture may be pulled like a drawstring to radially collapse the proximal end 304 of the stent 300 to facilitate removal of the stent 300 from a body lumen.
- the stent 300 may have a woven structure, fabricated from a number of filaments or struts 314 forming a tubular wall.
- the stent 300 may be knitted or braided with a single filament or strut interwoven with itself and defining open cells 316 extending through the thickness of the tubular wall of the stent 300.
- the stent 300 may be braided with several filaments or struts interwoven together and defining open cells 316 extending along a length and around the circumference of the tubular wall of the stent 300.
- the open cells 316 may each define an opening from an outer surface of the tubular wall to an inner surface of the tubular wall (e.g., through a thickness thereof) that is free from the filaments or struts 314.
- the stent 300 may be knitted.
- the stent 300 may be of a knotted type.
- the stent 300 may be a laser cut tubular member.
- a laser cut tubular member may have an open and/or closed cell geometry including one or more interconnected monolithic filaments or struts defining open cells 316 therebetween, with the open cells 316 extending along a length and around the circumference of the tubular wall.
- the open cells 316 may each define an opening from an outer surface of the tubular wall to an inner surface of the tubular wall (e.g., through a thickness thereof) that is free from the interconnected monolithic filaments or struts.
- an inner and/or outer surface of the tubular wall of the stent 300 may be partially, covered with a polymeric covering or coating 318.
- the covering or coating 318 may extend across and/or occlude one or more, or a plurality of the cells 316 defined by the struts or filaments 314.
- the coating 318 may include more than one layer and may be similar in form and function to the coating 40 described herein.
- the stent 300 may be a self-expanding stent (SES), although this is not required.
- SES self-expanding stent
- the coating 318 may partially cover the open cells 316 while leaving some cells 316 or circumferential regions 320a, 320b free from the coating 318.
- the regions 320a, 320b free from the coating 318 may allow for tissue in-growth in selective areas of the stent 300.
- the stent 300 includes two regions 320a, 320b generally or mostly free from the coating 318.
- a first region 320a may be proximate to and longitudinally spaced from the proximal end 304 and the second region 320b may be proximate to and longitudinally spaced from the distal end 306.
- the mostly coating-free regions 320a, 320b may start at or extend to the proximal end 304 or distal end 306, respectively.
- Other configurations of the mostly coating-free regions 320a, 320b may be used as desired.
- the stent 300 may include only a single coating-free region or may include more than two coating-free regions.
- the stent 300 may include a first end region 322 proximate the proximal end 304 and a second end region 324 proximate the second end 306.
- the first end region 322 and the second end region 324 may include retention features or anti-migration flared regions 326, 328 having enlarged diameters relative to the intermediate portion 308.
- the anti- migration flared regions 326, 328 which may be positioned adjacent to the first end 304 and the second end 306 of the stent 300, may be configured to engage an interior portion of the walls of the body lumen.
- the retention features, or flared regions 326, 328 may have a larger diameter than the cylindrical intermediate region 308 of the stent 300 to prevent the stent 300 from migrating once placed in the body lumen. It is contemplated that the transition 330, 332 from the cross-sectional area of the intermediate region 308 to the retention features or flared regions 326, 328 may be gradual, sloped, or occur in an abrupt step-wise manner, as desired.
- the first anti-migration flared region 326 may have a first outer diameter and the second anti-migration flared region 328 may have a second outer diameter. In some instances, the first and second outer diameters may be approximately the same, while in other instances, the first and second outer diameters may be different.
- the stent 300 may include only one or none of the anti-migration flared regions 326, 328.
- the first end region 322 may include an anti- migration flare 326 while the second end region 324 may have an outer diameter similar to the intermediate region 308.
- the second end region 324 may include an anti-migration flare 328 while the first end region 322 may have an outer Atty. Docket No.2001.3238111 diameter similar to an outer diameter of the intermediate region 308.
- the stent 300 may have a uniform outer diameter from the first end 304 to the second end 306. It is contemplated that the outer diameter of the stent 300 may be varied to suit the desired application.
- the elongated tubular member of the stent 300 can be made from a number of different materials such as, but not limited to, metals, metal alloys, shape memory alloys, and/or polymers, as desired, enabling the stent 300 to be expanded into shape when accurately positioned within the body.
- the material may be selected to enable the stent 300 to be removed with relative ease as well.
- the elongated tubular member of the stent 300 can be formed from alloys such as, but not limited to, nitinol and Elgiloy®.
- the stent 300 may be self-expanding or require an external force to expand the stent 300.
- composite filaments may be used to make the stent 300, which may include, for example, an outer shell or cladding made of nitinol and a core formed of platinum or other radiopaque material. It is further contemplated the elongated tubular member of the stent 300 may be formed from polymers including, but not limited to, polyethylene terephthalate (PET). In some instances, the filaments of the stent 300, or portions thereof, may be bioabsorbable or biodegradable, while in other instances the filaments of the stent 300, or portions thereof, may be biostable.
- the stent 300 may include one or more magnetic components 334.
- the one or more magnetic components 334 may be similar in form and function the magnetic components 52 described herein.
- the magnetic components 334 may be encapsulated between an inner layer and an outer layer of the coating 318. However, this is not required. In some cases, the magnetic component 334 may be on an inner surface of the inner layer or an outer surface of the outer layer of the coating 318.
- the one or more magnetic components 334 may be a colloid, such as, but not limited to, a silicone base having a quantity of ferromagnetic material, or other magnetic material, mixed therein.
- the magnetic components 334 may be positioned adjacent to or may even extend into the mostly coating-free regions 320a, 320b.
- the magnetic components 334 may be arranged in any uniform or non-uniform arrangement, as desired.
- the magnetic components 334 may be discrete elements disposed within the cells 316. In other cases, the magnetic components 334 may be elongated bars or strips. In yet other cases, the magnetic components 334 may substantially cover a portion of the stent 300. In some embodiments, “islands” or regions of coating 318 including one or more magnetic Atty. Docket No.2001.3238111 components 334 may extend into the generally coating-free regions 320a, 320b. This may allow for areas of tissue in-growth while also allowing the movement of the magnetic components 334 in response to an applied magnetic field to move the mostly coating-free regions 320a, 320b which may encourage tissue dislodgement.
- the stents, delivery systems, and the various components thereof may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material.
- suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear- elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium- molybdenum alloys, nickel-copper alloys, nickel-cobalt-chromium-molybdenum alloys, nickel-molybdenum alloys, other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium alloys
- suitable polymers for the stents or delivery systems may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBA
- stents or delivery systems may also be doped with, made of, or otherwise include a radiopaque material.
- Radiopaque materials are generally understood to be materials which are opaque to RF energy in the wavelength range spanning x-ray to gamma-ray (at thicknesses of ⁇ 0.005”). These materials are capable of producing a relatively dark image on a fluoroscopy screen relative to the light image that non-radiopaque materials such as tissue produce. This relatively bright image aids the user of the stents or delivery systems in determining its location.
- Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like.
- radiopaque marker bands and/or coils may also be incorporated into the design of the stents or delivery systems to achieve the same result. It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The scope of the disclosure is, of course, defined in the language in which the appended claims are expressed.
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Abstract
Description
Claims
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202480058165.6A CN121866027A (en) | 2023-07-17 | 2024-07-16 | Stent with anti-occlusion system |
| KR1020267004637A KR20260040048A (en) | 2023-07-17 | 2024-07-16 | Stent equipped with an occlusion prevention system |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202363514024P | 2023-07-17 | 2023-07-17 | |
| US63/514,024 | 2023-07-17 |
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| Publication Number | Publication Date |
|---|---|
| WO2025019488A1 true WO2025019488A1 (en) | 2025-01-23 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2024/038197 Pending WO2025019488A1 (en) | 2023-07-17 | 2024-07-16 | Stent with anti-occlusion system |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US20250025281A1 (en) |
| KR (1) | KR20260040048A (en) |
| CN (1) | CN121866027A (en) |
| WO (1) | WO2025019488A1 (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070093744A1 (en) * | 2004-01-20 | 2007-04-26 | Massachusetts General Hospital | Permanent thrombus filtering stent |
| US20140180392A1 (en) * | 2011-03-28 | 2014-06-26 | Technion Research & Developement Foundation Ltd. | Stent for restenosis prevention |
-
2024
- 2024-07-16 KR KR1020267004637A patent/KR20260040048A/en active Pending
- 2024-07-16 CN CN202480058165.6A patent/CN121866027A/en active Pending
- 2024-07-16 US US18/774,348 patent/US20250025281A1/en active Pending
- 2024-07-16 WO PCT/US2024/038197 patent/WO2025019488A1/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070093744A1 (en) * | 2004-01-20 | 2007-04-26 | Massachusetts General Hospital | Permanent thrombus filtering stent |
| US20140180392A1 (en) * | 2011-03-28 | 2014-06-26 | Technion Research & Developement Foundation Ltd. | Stent for restenosis prevention |
Also Published As
| Publication number | Publication date |
|---|---|
| KR20260040048A (en) | 2026-03-23 |
| CN121866027A (en) | 2026-04-14 |
| US20250025281A1 (en) | 2025-01-23 |
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