WO2001097717A1 - Dispositif de derivation de flux implantable - Google Patents

Dispositif de derivation de flux implantable Download PDF

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Publication number
WO2001097717A1
WO2001097717A1 PCT/US2000/017010 US0017010W WO0197717A1 WO 2001097717 A1 WO2001097717 A1 WO 2001097717A1 US 0017010 W US0017010 W US 0017010W WO 0197717 A1 WO0197717 A1 WO 0197717A1
Authority
WO
WIPO (PCT)
Prior art keywords
implantable device
side port
stent
lumen
flow
Prior art date
Application number
PCT/US2000/017010
Other languages
English (en)
Inventor
Howard R. Levin
David C. Lundmark
Original Assignee
Chf Solutions, Inc.
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 Chf Solutions, Inc. filed Critical Chf Solutions, Inc.
Priority to PCT/US2000/017010 priority Critical patent/WO2001097717A1/fr
Priority to AU2000260531A priority patent/AU2000260531A1/en
Publication of WO2001097717A1 publication Critical patent/WO2001097717A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/856—Single tubular stent with a side portal passage
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2476—Valves implantable in the body not otherwise provided for
    • 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
    • A61F2/94—Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
    • 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
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • 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
    • A61F2002/068—Modifying the blood flow model, e.g. by diffuser or deflector
    • 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
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2230/0067—Three-dimensional shapes conical

Definitions

  • the present invention relates to an intravascular expandable implant to maintain vascular patency in lumens of humans and animals while providing a construct for controlling and diverting flow to other body lumens.
  • Intravascular expandable implants such as stents and stent grafts have long been applied to maintain vascular patency.
  • Many intravascular stents are used in conjunction with balloon angioplasty wherein a balloon is inflated to expand a constricted vessel in order to restore proper blood flow. The intravascular stent is then positioned inside the expanded vessel to ensure the vessel maintains the enlarged diameter.
  • the loop of wire is compressed to form a series of straight segments and bends, the bends storing energy in the compressed state.
  • U.S. Patent No. 4,649,992 which describes a stent device in combination with a catheter.
  • the stent is a compression spring retained by a partially inflated balloon and an abutment immediately behind the balloon on the catheter shaft. The spring prosthesis is transported to the desired location and released by totally evacuating the balloon, thereby allowing the spring prosthesis to expand linearly.
  • U.S. Patent No. 4,768,507 which discloses a catheter comprising an outer cylinder and inner core.
  • the inner core has spiral grooves for holding a coil spring stent. Pliers are used to facilitate the loading of the coil spring into the grooves.
  • the outer cylinder Upon completion of the loading of the outer cylinder, it is placed over the inner core thereby retaining the coil in the compressed state until the coil is released.
  • U.S. Patents Nos. 4,690,684, and 4,720,176 each of which discloses a stent for aligning the ends of the vessel during anastomosis by thermal bonding.
  • the stent comprises an integral solid of biologically compatible material to align the vessel ends together during anastomosis. Upon completion of the anastomosis the stent fully melts into the fluid flowing through the vessel.
  • U.S. Patent No. 4,770,176 also discloses a method of anastomosing a vessel utilizing the stent described in U.S. Patent No. 4,690,684.
  • U.S. Patent No. 4,878,906 which describes a prosthesis coomprising a flexible thin-walled plastic sleeve for repairing damaged vessels.
  • the sleeve has sufficient length to cover the damaged area of the vessel by forming a sealed interface between its outer peripheral ends and the inner peripheral surface of the - vessel. A bridge is thereby provided to bypass the damaged area of the vessel.
  • U.S. Patent No. 4,830,003 which discloses a cylindrical stent comprising angled wires of bio- compatible metal.
  • the angled wires are connected obliquely at alternate ends to form a compressible ope ended tube.
  • U.S. Patent No. 4,866,062 which discloses a radially expandable coronary stent.
  • the stent comprises a flat expandable wire band which is preformed in a zigzag pattern to provide expansion capability.
  • the band is wound into a cylindrical shape and is inflated by means of a variable diameter device.
  • the band expands radially into a cylindrical shape with increasing diameter.
  • U.S. Patent No. 4,760,849 which discloses a planar blank which may be made into a helical coil spring stent.
  • U.S. Patent No. 4,665,918, which describes a system and method for implanting a generally tubular prosthesis member having an unobstructed central passageway into a blood vessel. The prosthesis member is positioned in a contracted condition between a delivery catheter and outer sheath, and expands outwardly in response to the removal of the sheath.
  • U.S. Patent No. 5,855,597 which discloses a stent valve and stent graft for percutaneous surgery.
  • a star- shaped stent and replacement valve or replacement graft for use in repairing a damaged cardiac valve includes two to eight star-shaped members interconnected into a chain.
  • 5,676,697 discloses an intraluminal graft and method and apparatus for installing an intraluminal graft in relation to a bifurcation of a trunk vessel into two branch vessels to 5 bypass an aneurysm defect or injury, wherein the intraluminal graft is formed of two cooperating graft prostheses.
  • This invention is an implantable device for placement in a body lumen which generally comprises an 15 expandable stent and a sheet-like member coupled to the expandable stent in a configuration wherein a flow diversion side port is formed in the side of the construct.
  • the stent has a compressed delivery state and an expanded implantation state, and is preferably 2.0 configured for delivery using a catheter.
  • side ports may be formed in the device, although a substantially circular side port geometry is preferred.
  • the side port may have a relatively small area, such as 1/10 of the stent inlet 25 lumen area, or it may have a relatively large area, such as 1/2 of the stent inlet lumen area or greater.
  • the expandable stent has two ends, an upstream end and a downstream end, defining the flow input lumen and flow output lumen, respectively.
  • the inlet lumen remains 30 opened, or un-occluded, after expansion of the stent.
  • the outlet lumen remains opened, and in others it is closed to facilitate flow diversion through the side port.
  • At least a portion of the expandable stent is radio-opaque
  • radio-opaque markers are disposed around the perimeter of the side port to facilitate accurate delivery and orientation of the implantable device using a catheter or similar endolumenal device.
  • An annulus of the sheet-like member defining the side port may be reinforced, preferably by an additional folded-over layer of the sheet-like member.
  • radio-opaque markers may be encapsulated within the two layers comprising the reinforced annulus defining the side port.
  • a sew ring or expandable T-graft may be attached to the annulus to facilitate formation of an end-to-side anastomoses using stitching techniques, glues, or other end-to-end fastening techniques.
  • the T-graft may be delivered in a low-profile configuration, such as an accordion shape or folded and flattened elongate shape, and may be pulled into a roughly cylindrical expanded implantation shape configured to facilitate formation of an anastomoses between a graft member and said implantable device.
  • the sheet-like member may comprise a semi-permeable material such as ePTFE to allow for flow-based nutrition of tissues, such as endothelial tissues, adjacent to the implantable device, while directing the vast majority of the flow through the stent lumen and/or side port after the device has been installed.
  • the sheet-like member may be attached to the expandable stent using adhesive, stitching, weaving, encapsulation, or a combination thereof.
  • the implantable device may further comprise a flexible wall member which is coupled to the device and configured to form an end wall when the stent is in its expanded implantation state.
  • the end wall is configured to substantially block the flow of fluids through one end of the stent lumen, thus helping to divert flows through the side port in a flow diversion configuration.
  • the flexible wall member may be coupled to the expandable stent or sheet-like member using adhesives, stitching, weaving, encapsulation, or a combination thereof.
  • the flexible wall member may also comprise a portion of the sheet-like member.
  • the end wall is configured to form a relatively flat surface perpendicular to a longitudinal axis of the stent lumen.
  • the end wall may be configured to divert flow through the side port using a relatively flat end wall positioned at an angle such as 45 degrees.
  • the end wall may also be configured to divert flow through the side port using a curved end wall.
  • the curved end wall may have a substantially constant radius of curvature. Angled and curved end wall variations are configured to minimize flow turbulence and the possibility of zero-velocity dead spots within and near the implanted device.
  • the implantable device may further comprise a valve having an open position and a closed position, the valve being configured to controllably allow or prevent flow through a valve door in the sheet-like member.
  • the valve may be located upon an end wall, and may have a remote shut-off mechanism to permanently close the valve door.
  • the remote shut-off mechanism may comprise an electrolytically dissolvable mechanical link interfaced with the valve so that the valve door cannot be closed until the link has been controllably dissolved.
  • the device may further comprise a remote valve lock-down mechanism having a pin which is operational to lock the valve into its closed position after the shut-off mechanism has allowed the valve door to close.
  • the implantable device may also comprise more than one side port for multiple flow diversions.
  • Figures 1A and IB depict orthogonal and front views, respectively, of a variation of the inventive device.
  • Figure 2A depicts a partial side view of a variation of the inventive device having a reinforced side port.
  • Figure 2B depicts a partial side view of a variation of the inventive device showing an attachment location for a sew ring or T-graft section.
  • Figure 2C depicts a top view of a variation of the device showing a T-graft section coupled to said device in an accordion delivery configuration.
  • Figure 2D depicts a top view of a variation of the device showing a T-graft section coupled to said device in a bent and flattened elongate delivery configuration.
  • Figure 3A depicts an orthogonal view of a variation of the inventive device.
  • Figure 3B is an orthogonal view of a variation of the sheet-like member.
  • Figure 4A depicts an orthogonal view of a variation of the inventive device having a long sheet-like member.
  • Figure 4B depicts an orthogonal view of a variation of the inventive device having a relatively small sheet- like member.
  • Figure 4C depicts an orthogonal view of a variation of the inventive device having a relatively small sheetlike member.
  • Figure 4D depicts an orthogonal view of a variation of the inventive device having an expanded T-graft section coupled to the sheet-like member.
  • Figure 5A depicts a sectional side view of a variation of the inventive device having an angled end wall .
  • Figure 5B depicts a sectional side view of a variation of the inventive device having a curved end wall .
  • Figure 5C depicts a side view of a variation of the inventive device having a perpendicular end wall.
  • Figure 5D depicts an orthogonal view of a dual-lumen variation of the inventive device.
  • Figure 5E depicts an orthogonal view of a venturi lumen variation of the inventive device.
  • Figure 5F depicts a sectional side view of a variation of the inventive device having a curved end wall and sensors .
  • Figure 6 depicts a sectional side view of a variation of the inventive device having an end wall with a valve .
  • Figure 7 depicts a sectional side view of a variation of the inventive device having an end wall with a valve .
  • Figure 8 depicts a sectional side view of a variation of the inventive device having an end wall with a valve .
  • Figure 9A depicts a sectional side view of a variation of the inventive device having an end wall with a valve .
  • Figure 9B depicts a close-up partial side view of a variation of the inventive device having an end wall with a valve .
  • Figure 9C depicts a close-up partial orthogonal view of a variation of the inventive device having an end wall with a valve.
  • Figure 9D depicts a close-up partial orthogonal view of a variation of the inventive device having an end wall with a valve.
  • Figure 9E depicts a close-up partial orthogonal view of a variation of the inventive device having an end wall with a valve.
  • Figure 9F depicts a close-up partial side view of a. variation of the inventive device having an end wall with a valve.
  • Figure 10 depicts a close-up partial bottom orthogonal view of a valve door and locking mechanism in a variation of the inventive device having an end wall with a valve.
  • Figure 11 depicts a close-up partial bottom orthogonal view of a valve door and locking mechanism in a variation of the inventive device having an end wall with a valve.
  • Figures 12A-12E depict a method for installing a variation of the inventive device.
  • This invention is an implantable device configured to facilitate the diversion of flows from one lumen to another.
  • FIGs 1A and IB an orthogonal view and front view of a variation of the inventive device (2) is depicted.
  • a substantially-cylindrical stent (3) is shown, having a collapsible structure which is preferably self-expanding.
  • the stent (3) is shown as it would appear when implanted into a body conduit with its diameter adjusted beyond the collapsed pre- implantation diameter.
  • the substantially cylindrical expanded shape defines an inner stent lumen (13) into which fluids may flow when the stent is in an implanted configuration.
  • stent shown is made from metal wire (15)
  • a polymeric stent or perforated sleeve having perforations of suitable shape, size, and quantity may be used.
  • Various suitable stents are described, .for instance, in U.S. Patent No. 4,776,337 to Palmaz and PCT US 92/03481 to Hess. These stents may be made from biocompatible implantable metals such as titanium, stainless steel, or Nitinol.
  • the stent (3) is preferably configured to have at least one region wherein a side port (4) for flow diversion, free of crossing stent structures, may be formed.
  • Stents with relatively loose structures are suitable, as are stents with structures designed for side port flow diversion. Stents may be made with such configurations using laser cutting and chemical etching procedures, such as those disclosed in U.S. Patents Nos. 5,879,370 and 5,855,597.
  • the stent is preferably at least partially radio-opaque or marked with radio-opaque markers to facilitate accurate delivery.
  • a sheet-like member (14) is shown coupled to the expandable stent (3) .
  • the sheet-like member (14) is configured to form a side port (4) through which flow may be diverted, while forming a localized barrier to flow for regions adjacent to the side port (4) .
  • the side port is preferably of an approximately circular geometry when viewed from the end, although other geometries, such as approximately rectangular side port shapes when viewed from the end, may be useful depending upon other componentry which may interface with the side port.
  • the diameter (5) of the side port (4) may vary, depending upon the particular application. For small side port flow rates, a diameter as small as 1/10 the size of the stent lumen (13) diameter (7) is preferred.
  • Figure 2A depicts a close-up partial side view of a variation of the inventive device wherein an approximately circular side port (4) is formed in the sheet-like member (14) .
  • This variation has a reinforced annulus (8) which defines the side port (4), the reinforced annulus (8) having higher stiffness than the other portions of the sheet-like member (14) to facilitate load bearing which may accompany anastomosis formation at the location of the side port (4) , depending upon what componentry is coupled to the device and how such componentry is coupled.
  • the reinforced annulus (8) may be formed by a folded-over layer of the sheet-like member (14) which is attached to the substrate layer using stitches, adhesives, thermal bonding, chemical bonding, or other known methods of coupling two relatively flexible flat surfaces.
  • the depicted variation comprises a folded-over layer of the sheet-like member (14) fastened to the substrate layer using a biocompatible polymeric adhesive such as those disclosed in U.S. Patent No. 5,810,870.
  • the depicted variation also comprises several radio- opaque markers (6) positioned around the perimeter of the side port (4) to facilitate imaging and accurate placement of the device (2) . These markers (6) may be encapsulated between layers forming a reinforced annulus (8), as in the depicted variation, or they may be attached by adhesives or other means.
  • Figure 2B depicts a similar variation of the inventive device in close-up partial side view further comprising a sew ring (10) coupled to the portions of the sheet-like member (14) which define the side port.
  • a T- graft section (18) may be coupled to the device in the same location as the sew ring (10) in the depicted variation.
  • a sew ring (10) or T-graft (18) may be incorporated to facilitate formation of an anastomoses at the site of the side port (4) .
  • Figures 2C and 2D depict top views of variations of the inventive device comprising T-graft sections (18) having T-graft lumens (19) .
  • an expandable T-graft section (18) is shown in a low-profile accordion compressed configuration (12) which facilitates catheter based delivery.
  • Figure 2D shows a T-graft section (18) against the device in a bent and flattened configuration (23) which also facilitates catheter based delivery.
  • the T-graft section Upon deployment of the device (2) , the T-graft section, either accordion compressed (12) or bent and flattened (23), may be pulled by a surgical grasping tool into an generally cylindrical extended configuration having a T- graft lumen (19) , as shown in Figure 4D.
  • the sheet-like member (14) may comprise various geometric configurations in relation to the generally cylindrical deployed stent (3) .
  • Figures 3A and 3B depict orthogonal views of a generally cylindrical sheet-like member (14) configuration, Figure 3A showing an apparatus (2) comprising a stent (3) and sheet-like member (14) with side port (4) .
  • Figure 3B depicts the sheet-like member of Figure 3A in isolation without the stent to which it is preferably coupled.
  • Figure 4A depicts a variation wherein the sheet-like member (14) extends the length of the expandable stent • (3) and forms a partial cylindrical surface defined by an angle of coverage (16) .
  • the depicted variation has an angle of coverage of approximately 90 degrees.
  • the preferred angle of coverage necessary to facilitate diversion of flows through the side port (4) without significant flow leakage in the region between the sheetlike member (14) and the tissue (64) forming the main lumen (1) varies from 10 degrees to 360 degrees depending upon factors such as endolu enal pressure, endolu enal flow rate, side port (4) diameter, stent lumen (13) diameter, the thrombogenicity of the materials comprising the stent (3) and sheet-like member (14), and the type of junction to be formed between the device and a diversion graft member (not shown) at the side port (4) location.
  • Patent application for "Anastomosis Device and Method” (attorney docket number 3659-8) is employed, or a T-graft or sew ring used to form an anastomoses between the tissue forming the main lumen and the material forming the diversion graft member, then it is desirable to minimize leakage between the sheet-like member and main lumen tissue since such leakage would not be contained by the main lumen or flow diversion graft lumen.
  • a larger sheet-like member (14) surface area is desired around the side port (4) .
  • the sheet-like member (14) extends away from the side port (4) by at least one side port diameter (5) in each direction. In other words, the sheet-like member extends away from the circumference of the side port (4) in each direction a distance equal to at least one times the diameter (5) of the side port (4) .
  • a sheet-like member (14) is shown coupled to an expandable stent (3) in a configuration extending the length of the expandable stent (3) and having an angle of coverage (16) of approximately 90 degrees, resulting in approximately one side port diameter (5) of surface coverage in each direction.
  • Figure 4B is an orthogonal view of a variation of the device in which the sheet-like member (14) has an approximately rectangular shape when viewed from the side.
  • Figure 4C depicts an orthogonal view of a variation of the device in which the sheet-like member (14) has an approximately circular shape when viewed from the side.
  • Figure 4D depicts the variation shown in Figure 4C further comprising a T-graft (18) which is coupled thereto, in this case depicted in an expanded T- graft configuration.
  • the sheet-like member (14) may be coupled to the expandable stent (3) using sutures, a biocompatible adhesive such as those disclosed in U.S. Patent No. 5,810,870, a woven coupling configuration such as that described in U.S. Patent No. 5,876,432, partial encapsulation of the stent (3) by the sheet-like member (14) , or other known methods for attaching a flexible sheet-like member to an expandable structure, such as those which are employed in the manufacture of stent- grafts .
  • the sheet-like member (14) is comprised of a flexible material, preferably a biocompatible polymer such as PTFE, expanded PTFE, polyethylene, polyethylene terepthalate, or polyurethane.
  • FIG. 5A a sectional side view of a variation of the inventive device is depicted, the inventive device having a flexible wall member (25) coupled across the stent lumen (13) to form an end wall (20) positioned at an end wall angle (22) .
  • the angled end wall of this variation is designed to divert flow in a flow path (58) through the side port (4) while minimizing flow turbulence in the stent (13) and associated lumens when the device (2) is in an implanted configuration.
  • the end wall angle (22) is preferably approximately 45 degrees for the depicted variation. To prevent the likelihood of zero-velocity or eddy regions, the distance (21) between the edge of the side port and end wall (20) is minimized.
  • This distance (21) may not be entirely eliminated in many cases due to the geometric constraints of certain anastomotic techniques and devices.
  • the anastomosis device (65) depicted in Figures 12D and 12E, for example, may require a small amount of such space (21) to accommodate radial extensions (67) .
  • the end wall (20) may be approximately flat when the expandable stent (3) is expanded, or it may form a partial cylindrical shape (69) as in the depicted variation.
  • the phrase "partial cylindrical shape" is meant to describe a gutter-like shape having a substantially straight end wall (20) spine. Variations having an angled end wall (20) with a partial cylindrical shape are believed to best minimize the occurrence of zero-velocity points or eddies within the stent lumen (13) .
  • Figure 5B depicts a similar variation of the inventive device in sectional side view in which a flexible wall member (25) forms a curved end wall (20) having an approximately constant radius of curvature (26) .
  • the curvature of the end wall (20) is designed to minimize flow turbulence and channel flows along a flow path (58) directly out of the side port (4) .
  • the curved end wall (20) may be configured to have an additional radius of curvature perpendicular to that of the wall's (20) spine, resulting in a curved gutter-like shape (also described as a shape similar to that of a jai-ali paddle or inverted saddle) , or it may not have a curvature in such perpendicular direction so the resultant shape resembles a concave loading ramp rather than an a curved gutter.
  • the preferred shape for minimizing flow turbulence, as depicted in the figure, is the curved gutter shape (70) .
  • Figure 5C depicts a side view of a variation of the inventive device wherein a relatively flat end wall (20) is formed by a flexible wall member (25) across one end of the stent lumen (13) .
  • a relatively flat end wall (20) is formed by a flexible wall member (25) across one end of the stent lumen (13) .
  • a pump lumen (74) contains an implantable fluid pumping mechanism (77) such as that disclosed in U.S. Patent No. 5,707,218.
  • a bypass lumen (75) is configured to allow flow to bypass the pump lumen (74) during installation of the device.
  • one end of the bypass lumen (74) has a valve (76) configured to controllably occlude the bypass lumen (74) when the pumping mechanism (77) has been made operational.
  • a control lead (71) configured to place the pumping mechanism (77) in electrical connection with a power source (not shown) and control system (not shown) is depicted extending from the device (78). Also depicted is a controllable valve (78) configured to connect with the control system and be remotely closeable over the opening of the bypass lumen (74), effectively selecting the pump lumen (75) as the only path for flow past the device (78). Remotely-operable valves are further discussed below.
  • an aperture may be surgically created in the associated tissue wall (not shown) , the control lead (71) pulled through the aperture, and the aperture sealed around the protruding control lead (71) using a purse- string suture or other standard technique or device.
  • FIG. 5E a variation of the inventive device is shown in orthogonal view having a relatively- small side port (4) and a venturi lumen (81) having tapered entrance (82) and exit (83) surfaces and a venturi throat (84) .
  • the venturi throat (84) is configured to provide high velocity flow and associated low pressure at the entrance region (85) of the side port (4) , thus providing a pressure gradient which may be operable to augment the flow of fluids into the venturi lumen (81) through the side port (4), depending upon other associated pressures as well as the viscosity of the fluids and other geometric factors .
  • FIG. 5F a variation of the inventive device similar to that of Figure 5B is depicted in sectional side view, this variation also having sensors or sensor portions (86) coupled thereto in a configuration where they are operable to monitor fluids flowing through the device (80).
  • sensors or sensor portions (86) coupled thereto in a configuration where they are operable to monitor fluids flowing through the device (80).
  • devices are disclosed having sensors similarly coupled thereto for similar functionality.
  • a control lead (71) extending from the device (80) and configured to establish communication between the sensors (86) and an associated control system (not shown) .
  • the flexible wall members (25) of Figures 5A-5F may be coupled to the stents (3) or sheet-like members (14) or both in the depicted variations using adhesives, stitching, weaving, encapsulation, a combination thereof, or other known coupling techniques.
  • the flexible wall member (25) is comprised of a flexible material, preferably a biocompatible polymer such as PTFE, expanded PTFE, polyethylene, or polyurethane .
  • Figure 6 depicts a sectional side view of a variation of the inventive device wherein a curved end wall (20) comprises a valve (28) having open and closed positions. When the valve door (30) is in an open position, a bifurcated flow path (58) results when flows exit the side port (4) .
  • a reed-type valve (28) is depicted, having a valve opening (36) , a valve door (30) which is rotatable about a valve door hinge point (32), and a valve door retainer (34) which is configured to hold the valve door (30) in open position.
  • the valve door retainer (34) preferably comprises an electrolytically erodable junction (54) like those used in other electrolytic release mechanisms. Examples of such release mechanisms are described in references such as U.S. Patents Nos. 5,122,136, 5,354,295, 5,891,128, and 5,624,449.
  • valve door (30) remains open until the erodable junction (54) has been eroded (56) , at which point the valve door (30) may close.
  • the valve door (30) may be biased to stay closed by fluid pressures within the stent lumen (13) or other associated lumens, or forces developed by a valve door closer member (38), such as that which is depicted in Figure 7 in sectional side view.
  • the valve door (30) closer member (38) preferably applies a spring-generated tension force to the valve door (30), operating to pull the valve door (30) shut when said erodable junction (54) has been eroded.
  • the valve door (30) boundary (46) shown in Figures 6-8 is configured to meet the valve door (30) when it is closed.
  • Figure 8 depicts a variation similar to that depicted in Figure 7, however the variation of Figure 8 has an end wall (20) with valve (28) located across one end of the stent lumen (13) , the valve door (30) being associated with a valve closer member (38) .
  • Figure 9A depicts in sectional side view a device similar to that shown in Figure 6, with the exception that the erodable junction (54) has been eroded (65) and the valve door (30) is shut against the valve door boundary (46) .
  • Figure 9B depicts a variation of the valve door (30) in shut configuration in a close-up partial side view.
  • the depicted reed-type valve (28) variation has a valve door (30) hinge (32), and a lock member aperture (45) which is designed to protrude through and beyond the portion of the end wall (20) with which it interfaces via a valve door lock member slot (48) in the end wall (20) .
  • the valve door (30) extends beyond the valve door boundary point (46), thus producing an overlap region (47) .
  • Figure 9C depicts a close-up partial orthogonal view of a variation of the inventive device having a locking pin (50) configured to side through a protruding lock member aperture (45) when the valve (28) is in a closed configuration, the locking pin (50) being operational to lock the valve door (30) into a closed position.
  • Figure 9D depicts a more magnified close-up partial orthogonal view of the device depicted in Figure 9C, this view illustrating the interface between the valve door (30) lock member (44) and the valve door (30) lock member slot (48) in the overlap region (47) of the end wall (not shown) .
  • Figures 9E and 9F are additional close-up partial orthogonal and partial side views, respectively, of the device depicted in Figure 9D which illustrate the configuration and operation of the valve door lock member (44) of this variation.
  • a spring member (52) and an erodable junction (54) are attached in parallel between an end wall (20) attachment base (51) and a locking pin (50) .
  • Figure 9F illustrates that when the erodable junction is eroded (56), the spring member (52) urges the locking pin (50) through the valve door lock member aperture (45), thus locking the valve door (30) into a shut configuration.
  • FIGS 10 and 11 depict close-up partial bottom orthogonal views of further variations of the inventive device wherein a valve door locking member (44) is configured to receive one or more locking pins (50) after an erodable junction (54) has been eroded (56) .
  • a valve door locking member (44) is configured to receive one or more locking pins (50) after an erodable junction (54) has been eroded (56) .
  • the valve (28) must be mounted upon a relatively stiff portion (31) of the end wall (20) .
  • Figure 10 depict such a stiff portion (31) , which preferably comprises a layer of a relatively stiff polymeric material such as PET, PETE, or polyethylene coupled to or forming a portion of the end wall (20) using an adhesive or encapsulation. Since this portion (31) is relatively stiff, it generally may not be compressed to a smaller size during delivery, and thus presents a geometric constraint which may prevent catheter-based delivery of devices which contain end walls (20) having relatively- large valves (28) and thus relatively-large stiff portions (31) .
  • a stiff portion (31) which preferably comprises a layer of a relatively stiff polymeric material such as PET, PETE, or polyethylene coupled to or forming a portion of the end wall (20) using an adhesive or encapsulation. Since this portion (31) is relatively stiff, it generally may not be compressed to a smaller size during delivery, and thus presents a geometric constraint which may prevent catheter-based delivery of devices which contain end walls (20) having relatively- large valves (28) and thus relatively-large stiff portions (31) .
  • Figures 12A-12E depict a method for installing a variation of the inventive device.
  • the preferred method of delivery requires a delivery catheter
  • non-catheter-based delivery techniques known in the art may also be suitable for installing the inventive device, depending upon the particular application.
  • a variation of the inventive device can be installed by surgically creating an arteriotomy and placing the device therethrough into an artery or other vessel, then suturing the arteriotomy closed.
  • Figure 12A depicts a catheter-based delivery of the device (2) wherein the device (2) is delivered to a desired location in compressed form within the catheter (60) and is then pushed out the end of the catheter (60) where it may expand to an implanted configuration, as shown in Figure 12B.
  • the depicted variation of the device (2) has an end wall (20) with a valve (28), the valve door (30) being in open position upon delivery, as shown in Figures 12B-12D.
  • a trocar (62) may be used to create a hole in the tissue wall (64) at the location of the side port (4) .
  • an anastomosis device (66) may then be placed through the tissue hole and side port (4) where it is locked into a final configuration, as is shown in Figures 12D and 12E.
  • the valve door (30) in the end wall (20) may be closed to facilitate flow diversion through the anastomoses device (66) .
  • stabilizing sutures (87) may also be installed to provide additional fastening stability to the implanted construct.
  • a control lead (71) for providing current to electrolytically erodable junctions (54) is also shown in Figures 12A-12E.
  • the control lead (71) trails behind the implant within the bounds of the tissue wall (64) .
  • a small aperture (72) may be surgically created through the tissue wall (64), through which the control lead (71) may be pulled.
  • the aperture (72) is then closed around the protruding control lead (72) using a purse-string suture (not shown) or other known closure technique or device.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un dispositif implantable généralement destiné à dévier au moins partiellement des flux de liquides dans une lumière anatomique vers une autre lumière définie par un greffon. Ce dispositif est composé d'un stent, souvent opaque à la radio, et d'un élément de type enveloppe couplé à ce stent et agencé de façon à former un orifice latéral à travers lequel des liquides peuvent être déviés. Ce dispositif peut comprendre divers agencements de parois d'extrémité qui sont agencées de façon à oblitérer au moins partiellement la lumière principale du stent. Ce dispositif peut aussi comprendre un anneau à coudre ou un greffon en T expansible agencé de façon à faciliter la formation d'une anastomose termino-latérale entre les vaisseaux contenant ce dispositif et un greffon au niveau de l'orifice latéral.
PCT/US2000/017010 2000-06-20 2000-06-20 Dispositif de derivation de flux implantable WO2001097717A1 (fr)

Priority Applications (2)

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PCT/US2000/017010 WO2001097717A1 (fr) 2000-06-20 2000-06-20 Dispositif de derivation de flux implantable
AU2000260531A AU2000260531A1 (en) 2000-06-20 2000-06-20 Implantable flow diversion device

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007027201A1 (fr) * 2005-08-29 2007-03-08 Boston Scientific Limited Stent a geometrie de branche laterale extensible
WO2007052279A2 (fr) * 2005-11-07 2007-05-10 Design & Performance - Cyprus Limited Ensemble greffon-endoprothese
US7914503B2 (en) 2002-09-20 2011-03-29 Angio Dynamics Method and apparatus for selective material delivery via an intra-renal catheter
US8518011B2 (en) 2004-03-04 2013-08-27 Angiodynamics, Inc. Sheath for use in peripheral interventions
US8585678B2 (en) 2002-09-20 2013-11-19 Angiodynamics, Inc. Method and apparatus for intra-aortic substance delivery to a branch vessel
WO2018220589A1 (fr) * 2017-06-02 2018-12-06 HemoDynamx Technologies, Ltd. Modification d'écoulement dans des lumières corporelles
CN113597291A (zh) * 2018-11-26 2021-11-02 内弗罗尼公司 体腔中的流动调节装置
US11324619B1 (en) 2020-05-28 2022-05-10 Nephronyx Ltd. Acute and chronic devices for modifying flow in body lumens and methods of use thereof
US11944337B2 (en) 2015-08-28 2024-04-02 Distalmotion Sa Surgical instrument with increased actuation force

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WO2000053118A1 (fr) * 1999-03-11 2000-09-14 Mindguard Ltd. Dispositif implantable de prevention des ictus

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US3868956A (en) 1972-06-05 1975-03-04 Ralph J Alfidi Vessel implantable appliance and method of implanting it
US4553545A (en) 1981-09-16 1985-11-19 Medinvent S.A. Device for application in blood vessels or other difficultly accessible locations and its use
US4503569A (en) 1983-03-03 1985-03-12 Dotter Charles T Transluminally placed expandable graft prosthesis
US4580568A (en) 1984-10-01 1986-04-08 Cook, Incorporated Percutaneous endovascular stent and method for insertion thereof
US4649992A (en) 1984-10-05 1987-03-17 Plessey Overseas Limited Diamond heatsink assemblies
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WO2000053118A1 (fr) * 1999-03-11 2000-09-14 Mindguard Ltd. Dispositif implantable de prevention des ictus

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7914503B2 (en) 2002-09-20 2011-03-29 Angio Dynamics Method and apparatus for selective material delivery via an intra-renal catheter
US8585678B2 (en) 2002-09-20 2013-11-19 Angiodynamics, Inc. Method and apparatus for intra-aortic substance delivery to a branch vessel
US8518011B2 (en) 2004-03-04 2013-08-27 Angiodynamics, Inc. Sheath for use in peripheral interventions
WO2007027201A1 (fr) * 2005-08-29 2007-03-08 Boston Scientific Limited Stent a geometrie de branche laterale extensible
WO2007052279A2 (fr) * 2005-11-07 2007-05-10 Design & Performance - Cyprus Limited Ensemble greffon-endoprothese
WO2007052279A3 (fr) * 2005-11-07 2007-07-19 Design & Performance Cyprus Lt Ensemble greffon-endoprothese
US11944337B2 (en) 2015-08-28 2024-04-02 Distalmotion Sa Surgical instrument with increased actuation force
WO2018220589A1 (fr) * 2017-06-02 2018-12-06 HemoDynamx Technologies, Ltd. Modification d'écoulement dans des lumières corporelles
CN110891522A (zh) * 2017-06-02 2020-03-17 内弗罗尼公司 体腔中的流动调节
US20200138560A1 (en) * 2017-06-02 2020-05-07 Nephronyx Ltd. Flow modification in body lumens
CN110891522B (zh) * 2017-06-02 2021-12-14 内弗罗尼公司 体腔中的流动调节
US11607532B2 (en) 2017-06-02 2023-03-21 Nephronyx Ltd. Flow modification in body lumens
US10195406B2 (en) 2017-06-02 2019-02-05 HemoDynamx Technologies, Ltd. Flow modification in body lumens
CN113597291A (zh) * 2018-11-26 2021-11-02 内弗罗尼公司 体腔中的流动调节装置
US11324619B1 (en) 2020-05-28 2022-05-10 Nephronyx Ltd. Acute and chronic devices for modifying flow in body lumens and methods of use thereof

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