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 sheets or tubes, e.g. perforated by laser cuts or etched holes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2/958—Inflatable balloons for placing stents or stent-grafts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
  • A61F2002/8483—Barbs
• • 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
  • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2220/0008—Fixation appliances for connecting prostheses to the body
  • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
• • 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
  • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
  • A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
• • 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
  • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
  • A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded

Definitions

• the invention relates to a medical device fixation anchor and in particular with an anchor that is suitable for use with a balloon expandable stent.
• Various medical devices require some form of fixation or anchoring to a targeted site.
• Common anchoring means include barbs, hooks, sutures, or other features used to attach a device to the surrounding anatomy.
• Some examples of devices requiring a means to anchor include vena-cava filters, stents, stent grafts, bile/urinary duct stents, intestinal/gastro stents and liners, occluders, electrophysiological leads, various monitors or diagnostic devices, central venous catheters, and other devices as commonly know in the art. Many of these devices incorporate a balloon expandable component that is expanded to bear against the surrounding anatomy, thus providing an anchoring means.
• the degree of positional anchoring of the medical device is normally dependent upon the degree of "over-expansion" of the balloon expandable component.
• the expandable portion When over-expanded, the expandable portion is aggressively forced against the surrounding anatomy, affecting a frictional or "interference-fit" means of anchoring. If the degree of over- expansion is excessive, the surrounding anatomy can be damaged. Conversely, if the degree of over-expansion is minimal, the device may dislodge due to poor anchoring.
• An improved means of anchoring a balloon expandable component incorporates expandable anchors or barbs. These expandable anchors eliminate the need for aggressive over-expansion and provide a degree of anchoring if the over-expansion is minimal.
• An improved, balloon expandable anchor can also improve the retention of the expandable component to the balloon.
• the improved balloon expandable anchors can be contained within the profile of the expandable device, so they do not interfere with the delivery of the device.
• An embodiment of the present invention includes a medical fixation device, comprising: a medical fixation device having a balloon expandable anchor with a device attachment portion, an expansion bearing portion and a barb portion; the anchor expansion bearing portion being positioned between the anchor device attachment portion and the anchor barb portion; the device attachment portion being coupled to an expandable medical device having a first compacted profile and a second expanded profile; the anchor barb portion positioned within the first compacted profile; and the anchor being deformed to extend the anchor barb portion outside the second expanded profile.
• Figure 1 A is a partial side view of a medical device prior to implantation.
• the medical device shown is a balloon expandable stent surrounding a balloon and a delivery catheter.
• Figure 1 B is a partial side view of a medical device that has been balloon expanded.
• Figures 2A and 2B are partial side views of an improved balloon expandable anchor showing the anchor barb contained within a first compacted device profile and shown outside of an expanded device profile.
• Figure 3 is a partial side view of a balloon expanded medical device having two anchor barbs extending outside of a device expanded profile.
• the invention is directed to a medical device anchoring or fixation means that enhances the ease of initial compaction and subsequent device deployment.
• Figures 1A and 1 B show a general example of a medical device delivery sequence. Shown in partial side view, Figure 1A is a compacted medical device 100. The specific medical device shown is a balloon expandable stent 102. The medical device is shown positioned within a lumen 104. The balloon expandable stent 102 is shown compacted onto a balloon (not shown) and delivery catheter 106.
• Figure 1 B is the medical device 100 in an expanded state. Shown are a balloon expandable stent 102 (shown in an expanded shape), an expanded balloon 108 and the delivery catheter 106. In a typical procedure, the internal balloon pressure expands a malleable stent (or other device), forcing the malleable stent into contact with the surrounding anatomy or lumen wall 104. The magnitude of balloon pressure normally dictates the outer profile of the stent and the degree of over-expansion or embedding into a vessel wall.
• FIGS 2A and 2B are partial side views of an improved balloon expandable anchor.
• the expandable medical device 200 is shown within a lumen 104 and surrounding an inflatable balloon 202.
• the medical device has an expandable anchor 204 having a device attachment portion 206 (used to couple the anchor to a medical device), an expansion bearing portion 208 and a barb portion 210.
• the medical device 200 is shown having a first compacted profile 212.
• the anchor barb portion 210 is contained within 214 the first compacted profile 212.
• An expansion bearing portion 208 can be configured in a variety of ways and may include curved, protruding, flat, or any other profile that will result in the barb portion 210 being contained within the first compacted profile 212.
• FIG. 3 Shown in Figure 3 is a partial side view of a balloon expandable medical device 300, surrounding an expanded balloon 108 and a delivery catheter 106.
• the expanded medical device 300 is shown having a second expanded profile 302 and two anchor barb portions 210.
• the two anchor barb portions 210 are shown extending outside 304 of the second expanded profile 302.
• the expandable anchors of the present invention may also be used with other means to expand, such as mechanical bow-arms, expandable "Chinese lanterns", expandable baskets, or other expanding devices or materials.
• Balloon expandable anchors can comprise commonly known materials (or combinations of materials) used in the manufacture of balloon expandable stents. Typical materials include 316L stainless steel, cobalt-chromium-nickel-molybdenum-iron alloy ("cobalt- chromium”), other cobalt alloys such as L605, tantalum, malleable Nitinol, or other bio-compatible malleable metals. Other suitable materials include specialized malleable polymers, malleable bio- absorbable materials, and the like.
• Typical methods used in the assembly of anchors to medical devices include commonly known techniques used to attach two or more components.
• permanent attachments include the use of glues, adhesives, welds, insert molding, heavy press-fits, one-way snap or lock features, pressed pins, heat staking, and rivets.
• semi-permanent attachments or those that require a tool to separate the components include screws, threaded fasteners, snap-rings, and snap- fits.
• Examples of releasable attachments or those that can be separated by hand without the use of an additional tool include snap-fits, twist lock features, push to release features, squeeze to release features, slide levers, latches, and light press-fits.
• Anchors can have various cross-sectional profiles such as circular, oval, rectangular, or other polygon shapes. Anchors can also incorporate external lubricious layers, lubricious coatings, or lubricious wrappings to minimize friction. Anchors can also incorporate therapeutic agents tailored for specific biological results. Anchors can also include radiopaque markers or radiopaque intensifiers.

Landscapes

• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Physics & Mathematics (AREA)
• Vascular Medicine (AREA)
• Optics & Photonics (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Materials For Medical Uses (AREA)
• Prostheses (AREA)
• Surgical Instruments (AREA)

Priority Applications (8)

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

Country Status (10)

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Citations (2)

Family Cites Families (17)

• 2010
  • 2010-06-17 US US12/817,234 patent/US9814609B2/en active Active
  • 2010-06-17 BR BRPI1016018-3A patent/BRPI1016018A2/pt not_active Application Discontinuation
  • 2010-06-17 CN CN201080031908.9A patent/CN102481198B/zh active Active
  • 2010-06-17 WO PCT/US2010/001748 patent/WO2010147658A1/en not_active Ceased
  • 2010-06-17 ES ES10728936T patent/ES2797524T3/es active Active
  • 2010-06-17 AU AU2010260540A patent/AU2010260540A1/en not_active Abandoned
  • 2010-06-17 EP EP10728936.5A patent/EP2442762B1/en active Active
  • 2010-06-17 RU RU2012101412/14A patent/RU2512816C2/ru active
  • 2010-06-17 CA CA2765906A patent/CA2765906C/en active Active
  • 2010-06-17 JP JP2012516063A patent/JP5746160B2/ja active Active

Patent Citations (2)

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