US20110208288A1 - Stents and stent grafts - Google Patents
Stents and stent grafts Download PDFInfo
- Publication number
- US20110208288A1 US20110208288A1 US13/040,755 US201113040755A US2011208288A1 US 20110208288 A1 US20110208288 A1 US 20110208288A1 US 201113040755 A US201113040755 A US 201113040755A US 2011208288 A1 US2011208288 A1 US 2011208288A1
- Authority
- US
- United States
- Prior art keywords
- stent
- graft
- proximal
- mandrel
- wire
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
Images
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
- A61F2/852—Two or more distinct overlapping stents
-
- 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
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
-
- 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
-
- 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
- A61F2/82—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
- A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
-
- 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
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
-
- 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
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- 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
- A61F2002/828—Means for connecting a plurality of stents allowing flexibility of the whole structure
-
- 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
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
-
- 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
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
- A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
-
- 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
- A61F2002/9528—Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents
-
- 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
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
-
- 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
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
-
- 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
- A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
-
- 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
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49799—Providing transitory integral holding or handling portion
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T74/00—Machine element or mechanism
- Y10T74/18—Mechanical movements
- Y10T74/1836—Rotary to rotary
- Y10T74/18392—Crank, pitman, and crank
Definitions
- the invention lies in the field of endoluminal blood vessel repairs.
- the invention specifically relates to a method for making a non-circular stent, which can be used to endoluminally repair aneurysm and/or dissections of the thoracic transverse aortic arch, thoracic posterior aortic arch, and the descending thoracic portion of the aorta.
- a stent graft is an implantable device made of a tube-shaped surgical graft covering and an expanding or self-expanding frame.
- the stent graft is placed inside a blood vessel to bridge, for example, an aneurismal, dissected, or other diseased segment of the blood vessel, and, thereby, exclude the hemodynamic pressures of blood flow from the diseased segment of the blood vessel.
- a stent graft advantageously eliminates the need to perform open thoracic or abdominal surgical procedures to treat diseases of the aorta and eliminates the need for total aortic reconstruction.
- the patient has less trauma and experiences a decrease in hospitalization and recovery times.
- the time needed to insert a stent graft is substantially less than the typical anesthesia time required for open aortic bypass surgical repair, for example.
- vascular grafts Use of surgical and/or endovascular grafts have widespread use throughout the world in vascular surgery. There are many different kinds of vascular graft configurations. Some have supporting framework over their entirety, some have only two stents as a supporting framework, and others simply have the tube-shaped graft material with no additional supporting framework, an example that is not relevant to the present invention.
- Gianturco One of the most commonly known supporting stent graft frameworks is that disclosed in U.S. Pat. Nos. 5,282,824 and 5,507,771 to Gianturco (hereinafter collectively referred to as “Gianturco”). Gianturco describes a zig-zag-shaped, self-expanding stent commonly referred to as a z-stent.
- the stents are, preferably, made of nitinol, but also have been made from stainless steel and other biocompatible materials.
- the first significant feature is the tube of graft material.
- This tube is commonly referred to as the graft and forms the tubular shape that will, ultimately, take the place the diseased portion of the blood vessel.
- the graft is, preferably, made of a woven sheet (tube) of polyester or PTFE.
- the circumference of the graft tube is, typically, at least as large as the diameter and/or circumference of the vessel into which the graft will be inserted so that there is no possibility of blood flowing around the graft (also referred to as endoleak) to either displace the graft or to reapply hemodynamic pressure against the diseased portion of the blood vessel.
- self-expanding frameworks are attached typically to the graft material, whether on the interior or exterior thereof. Because blood flow within the lumen of the graft could be impaired if the framework was disposed on the interior wall of the graft, the framework is connected typically to the exterior wall of the graft.
- the ridges formed by such an exterior framework help to provide a better fit in the vessel by providing a sufficiently uneven outer surface that naturally grips the vessel where it contacts the vessel wall and also provides areas around which the vessel wall can endothelialize to further secure the stent graft in place.
- One type of prior art prosthetic device is a stent graft made of a self-expanding metallic framework.
- the stent graft is, first, radially compressed and loaded into an introducer system that will deliver the device to the target area.
- the introducer system holding the stent graft positioned in an appropriate location in the vessel and allowed to open the radial force imparted by the self-expanding framework is helpful, but, sometimes, not entirely sufficient, in endoluminally securing the stent graft within the vessel.
- Lenker discloses an example of a stein graft delivery system.
- Lenker discloses various embodiments in which a sheath is retractable proximally over a prosthesis to be released,
- Lenker names components 72 and 76 , respectively, as “sheath” and “prosthesis-containment sheath.”
- the latter is merely the catheter in which the prosthesis 74 and the sheath 72 are held.
- FIGS. 1 the catheter in which the prosthesis 74 and the sheath 72 are held.
- the sheath 82 has inner and outer layers 91 , 92 fluid-tightly connected to one another to form a ballooning structure around the prosthesis P.
- This ballooning structure inflates when liquid is inflated with, a non-compressible fluid medium and flares radially outward when inflated.
- Lenker discloses the “sheath” 120 , which is merely the delivery catheter, and an eversible membrane 126 that “folds back over itself (everts) as the sheath 120 is retracted so that there are always two layers of the membrane between the distal end of the sheath [ 120 ] and the prosthesis P.” Lenker at col. 9 , lines 63 to 66 .
- the Lenker delivery system shown in FIGS. 19A to 19D holds the prosthesis P at both ends 256 , 258 while an outer catheter 254 is retracted over the prosthesis P and the inner sheath 260 .
- the inner sheath 260 remains inside the outer catheter 254 before, during, and after retraction.
- FIGS. 23A and 23B Another structure for holding the prosthesis P at both ends is illustrated in FIGS. 23A and 23B .
- the proximal holder having resilient axial members 342 is connected to a proximal ring structure 346 .
- FIGS. 24A to 24C also show an embodiment for holding the prosthesis at both ends inside thin-walled tube 362 .
- proximal and/or distal stents that are not entirely covered by the graft material.
- these stents have the ability to expand further radially than those stents that are entirely covered by the graft material.
- the proximal/distal stent ends better secure to the interior wall of the vessel and, in doing so, press the extreme cross-sectional surface of the graft ends into the vessel wall to create a fixated blood-tight seal.
- the modular stent graft assembly therein has a three-part stent graft: a two-part graft having an aortic section 12 and an iliac section 14 (with four sizes for each) and a contralateral iliac occluder 80 .
- FIGS. 1 , 2 , and 4 to 6 show the attachment stent 32 . As illustrated in FIGS. 1 , 2 , and 4 , the attachment stent 32 , while rounded, is relatively sharp and, therefore, increases the probability of puncturing the vessel.
- Hoganson a second example of a prior art exposed stent can be found in U.S. Patent Publication 2003/0074049 to Hoganson et al. (hereinafter “Hoganson”), which discloses a covered stent 10 in which the elongated portions or sections 24 of the ends 20 a and 20 b extend beyond the marginal edges of the cover 22 . See Hoganson at FIGS. 1 , 3 , 9 , 11 a , 11 b , 12 a , 12 b , and 13 . However, these extending exposed edges are triangular, with sharp apices pointing both upstream and downstream with regard to a graft placement location.
- Hoganson teaches completely covering the extended stent and, therefore, the absence of a stent extending from the cover 22 . It is noted that the Hoganson stent is implanted by inflation of a balloon catheter.
- White I Another example of a prior art exposed stent can be found in U.S. Pat. No. 6,565,596 to White at al. (hereinafter “White I”), which uses a proximally extending stent to prevent twisting or kinking and to maintain graft against longitudinal movement.
- the extending stent is expanded by a balloon and has a sinusoidal amplitude greater than the next adjacent one or two sinusoidal wires.
- White I indicates that it is desirable to space wires adjacent upstream end of graft as close together as is possible.
- the stent wires of White I are actually woven into graft body by piercing the graft body at various locations. See White I at FIGS. 6 and 7 .
- the rips in the graft body can lead to the possibility of the exposed stent moving with respect to the graft and of the graft body ripping further.
- the graft body has apertures.
- FIGS. 1 and 2 of Hartley particularly disclose a proximal first stent 1 extending proximally from graft proximal end 4 with both the proximal and distal apices narrowing to pointed ends.
- Pinheiro I Yet another example of a prior art exposed stent can be found in U.S. Pat. No. 6,355,056 to Pinheiro (hereinafter “Pinheiro I”). Like the Hartley exposed stent, Pinheiro discloses exposed stents having triangular, sharp proximal apices.
- White II U.S. Pat. No. 6,099,558 to White et al.
- the White II exposed stent is similar to the exposed stent of White I and also uses a balloon to expand the stent.
- Pinheiro II An additional example of a prior art exposed stent can be found in U.S. Pat. No. 5,851,228 to Pinheiro (hereinafter “Pinheiro II”).
- the Pinheiro II exposed stents are similar to the exposed stents of Pinheiro I and, as such, have triangular, sharp, proximal apices.
- Lenker U.S. Pat. No. 5,824,041
- Lenker shows a squared-off end of the proximal and distal exposed band members 14 .
- a portion of the exposed members 14 that is attached to the graft material 18 , 20 is longitudinally larger than a portion of the exposed members 14 that is exposed and extends away from the graft material 18 , 20 , Lenker et al. does not describe the members 14 in any detail.
- a final example of a prior art exposed stent can be found in U.S. Pat. No. 5,755,778 to Kleshinski.
- the Kleshinski exposed stents each have two different shaped portions, a triangular base portion and a looped end portion.
- the totality of each exposed cycle resembles a castellation. Even though the end-most portion of the stent is curved, because it is relatively narrow, it still creates the possibility of piercing the vessel wall.
- a second of such devices is the placement of a relatively stiff longitudinal support member longitudinally extending along the entirety of the graft.
- the typical stent graft has a tubular body and a circumferential framework. This framework is not usually continuous. Rather, it typically takes the form of a series of rings along the tubular graft. Some stent grafts have only one or two of such rings at the proximal and/or distal ends and some have many stents tandemly placed along the entirety of the graft material. Thus, the overall stent graft has an “accordion” shape. During the systolic phase of each cardiac cycle, the hemodynamic pressure within the vessel is substantially parallel with the longitudinal plane of the stent graft.
- a device having unsecured sterns could behave like an accordion or concertina with each systolic pulsation, and may have a tendency to migrate downstream.
- a downstream migration to achieve forward motion, has a repetitive longitudinal compression and extension of its cylindrical body.
- Such movement is entirely undesirable.
- Connecting the stents with support along the longitudinal extent of the device thereof can prevent such movement.
- a second anti-migration device can be embodied as a relatively stiff longitudinal bar connected to the framework.
- a clear example of a longitudinal support bar can be found in Pinheiro I (U.S. Pat. No. 6,355,056) and Pinheiro II (U.S. Pat. No. 5,851,228).
- Each of these references discloses a plurality of longitudinally extending struts 40 extending between and directly interconnecting the proximal and distal exposed stents 20 a , 20 b .
- These struts 40 are designed to extend generally parallel with the inner lumen 15 of the graft 10 , in other words, they are straight.
- FIG. 3 Another example of a longitudinal support bar can be found in U.S. Pat. No. 6,464,719 to Jayaraman.
- the Jayaraman stent is formed from a graft tube 21 and a supporting sheet 1 made of nitinol. This sheet is best shown in FIG. 3 .
- the end pieces 11 , 13 of the sheet are directly connected to one another by wavy longitudinal connecting pieces 15 formed by cutting the sheet 1 .
- the sheet 1 is coiled with or around the cylindrical tube 21 . See FIGS. 1 and 4 .
- a plurality of connecting pieces 53 with holes at each end thereof can be attached to a cylindrical fabric tube 51 by stitching or sutures 57 , as shown in FIG. 8 .
- Jayaraman requires more than one of these serpentine shaped connecting pieces 53 to provide longitudinal support.
- United States Patent Publication 2002/0016627 and U.S. Pat. No. 6,312,458 to Golds each disclose a variation of a coiled securing member 20 .
- FIG. 8 of Lazarus illustrates the longitudinal support structures 38 attached to a distal structure 36 and extending almost all of the way to the proximal structure 36 .
- the longitudinal structures 38 , 84 , 94 can, be directly connected to the body 22 , 80 and can be telescopic 38 , 64 .
- Van Schie does not disclose a support bar. Rather, it discloses a curved stent graft using an elastic material 8 connected to stents at a proximal end 2 and at a distal end 3 (see FIGS. 1 , 2 ) thereof to create a curved stent graft. Because Van Schie needs to create a flexible curved graft, the elastic material 8 is made of silicone rubber or another similar material. Thus, the material 8 cannot provide support in the longitudinal extent of the stent graft. Accordingly, an alternative to the elastic support material 8 is a suture material 25 shown in FIGS. 3 to 6 .
- the invention provides a method of forming a non-circular stent that overcomes the hereinafore-mentioned disadvantages of the heretofore-known devices and methods of this general type and that provides a vessel repair device that implants/conforms more efficiently within the natural or diseased course of the aorta by aligning with the natural curve of the aorta, decreases the likelihood of vessel puncture, increases the blood-tight vascular connection, retains the intraluminal wall of the vessel position, is more resistant to migration, and delivers the stent graft into a curved vessel while minimizing intraluminal forces imparted during delivery and while minimizing the forces needed for a user to deliver the stent graft into a curved vessel.
- method for manufacturing a stent including the steps of providing a mandrel with an outer surface having a polygonal cross-sectional shape and a longitudinal axis, winding stent wire around the outer surface of the mandrel about the longitudinal axis into a desired final shape, the desired final shape being polygonal in an elevation orthogonal to the longitudinal axis, and forming a stent by setting the wound stent wire in the desired polygonal final shape.
- a method for manufacturing a stent including the steps of providing a mandrel with a multiple-sided outer surface and a longitudinal axis, winding a stent wire around the outer surface of the mandrel into a desired final shape substantially corresponding to a shape of the outer surface, and forming a stent by setting the wound stent wire into the desired final shape.
- the mandrel is provided with flat sections and rounded edge portions between the flat sections.
- the stent forming step is carried out by setting the stent wire to have rounded edges corresponding to the rounded edge portions of the mandrel and with flat sides corresponding to the flat sections of the mandrel.
- pins are placed on the outer surface of the mandrel longitudinally offset from one another and corresponding to desired Z-stent apex locations and Z-stent apices are formed by winding the stent wire around the pins.
- the pin placing step is carried out by placing the pins on the mandrel to protrude perpendicularly from the outside surface of the mandrel.
- pins are placed on at least some of the rounded edge portions of the mandrel longitudinally offset from one another and corresponding to desired Z-stent apex locations and Z-stent apices are formed by winding the stent wire around the pins.
- the pins are placed at each of the rounded edge portions of the mandrel and the setting step is carried out to form the stent with substantially linear struts lying flat against the flat sections of the mandrel.
- the mandrel is provided in a dodecahedron shape and the setting step is carried out on the mandrel to form a Z-stent having six proximal and six distal apices.
- two ends of the stent wire are fastened to one another to complete the stent.
- the stent wire is initially provided as a cold-drawn shape-memory wire and the setting step is carried out by heat-treatment.
- the heat-treatment step is carried out by exposing the shape-memory wire to a heat-setting temperature for a period of time with subsequent quenching as required to shape set the shape-memory wire to the then-existing shape of the wire on the mandrel and obtain superelastic mechanical characteristics of the shape-memory wire.
- the setting step by exposing the wire to a process that shapes the wire to the then-existing shape of the wire on the mandrel selected from at least one of the group consisting of a mechanical process, a thermal process, and a chemical process.
- the outer surface of the mandrel is provided with a polygonal cross-sectional shape.
- the desired final shape is polygonal in an elevation orthogonal to the longitudinal axis.
- the mandrel is provided with flat sections and rounded edge portions between the flat sections; and the stent forming step is carried out by setting the stent wire to have rounded edges corresponding to the rounded edge portions of the mandrel and with flat sides corresponding to the flat sections of the mandrel.
- FIG. 1 is a side elevational view of a stent graft according to the invention
- FIG. 2 is a side elevational view of a stent of the stent graft of FIG. 1 ;
- FIG. 3 is a cross-sectional view of the stent of FIG. 2 with different embodiments of protrusions;
- FIG. 4 is a perspective view of a prior art round mandrel for forming prior art stents
- FIG. 5 is a fragmentary, side elevational view of a prior art stent in a portion of a vessel
- FIG. 6 is a perspective view of a dodecahedral-shaped mandrel for forming stents in FIGS. 1 to 3 ;
- FIG. 7 is a fragmentary, side elevational view of the stent of FIGS. 1 to 3 in a portion of a vessel;
- FIG. 8 is a fragmentary, enlarged side elevational view of the proximal end of the stent graft of FIG. 1 illustrating movement of a gimbaled end;
- FIG. 9 is a side elevational view of a two-part stent graft according to the invention.
- FIG. 10 is a fragmentary, side elevational view of a delivery system according to the invention with a locking ring in a neutral position;
- FIG. 11 is a fragmentary, side elevational view of the delivery system of FIG. 10 with the locking ring in an advancement position and, as indicated by dashed lines, a distal handle and sheath assembly in an advanced position;
- FIG. 12 is a fragmentary, enlarged view of a sheath assembly of the delivery system of FIG. 10 ;
- FIG. 13 is a fragmentary, enlarged view of an apex capture device of the delivery system of FIG. 10 in a captured position;
- FIG. 14 is a fragmentary, enlarged view of the apex capture device of FIG. 13 in a released position
- FIG. 15 is a fragmentary, enlarged view of an apex release assembly of the delivery system of FIG. 10 in the captured position;
- FIG. 16 is a fragmentary, enlarged view of the apex release assembly of FIG. 15 in the captured position with an intermediate part removed;
- FIG. 17 is a fragmentary, enlarged view of the apex release assembly of FIG. 16 in the released position
- FIG. 18 is a fragmentary, side elevational view of the delivery system of FIG. 11 showing how a user deploys the prosthesis;
- FIG. 19 is a fragmentary cross-sectional view of human arteries including the aorta with the assembly of the present invention in a first step of a method for inserting the prosthesis according to the invention;
- FIG. 20 is a fragmentary cross-sectional view of the arteries of FIG. 19 with the assembly in a subsequent step of the method for inserting the prosthesis;
- FIG. 21 is a fragmentary cross-sectional view of the arteries of FIG. 20 with the assembly in a subsequent step of the method for inserting the prosthesis;
- FIG. 22 is a fragmentary cross-sectional view of the arteries of FIG. 21 with the assembly in a subsequent step of the method for inserting the prosthesis;
- FIG. 23 is a fragmentary cross-sectional view of the arteries of FIG. 22 with the assembly in a subsequent step of the method for inserting the prosthesis;
- FIG. 24 is a fragmentary cross-sectional view of the arteries of FIG. 23 with the assembly in a subsequent step of the method for inserting the prosthesis;
- FIG. 25 is a fragmentary, diagrammatic, perspective view of the coaxial relationship of delivery system lumen according to the invention.
- FIG. 26 is a fragmentary, cross-sectional view of the apex release assembly according to the invention.
- FIG. 27 is a fragmentary, side elevational view of the stent graft of FIG. 1 with various orientations of radiopaque markers according to the invention
- FIG. 28 is a fragmentary perspective view of the stent graft of FIG. 1 with various orientations of radiopaque markers according to the invention
- FIG. 29 is a perspective view of a distal apex head of the apex capture device of FIG. 13 ;
- FIG. 30 is a fragmentary side elevational view of the distal apex head of FIG. 29 and a proximal apex body of the apex capture device of FIG. 13 with portions of a bare stent in the captured position;
- FIG. 31 is a fragmentary, side elevational view of the distal apex head and proximal apex body of FIG. 30 with a portion of the proximal apex body cut away to illustrate the bare stent in the captured position;
- FIG. 32 is a fragmentary side elevational view of the distal apex head and proximal apex body of FIG. 30 in the released position;
- FIG. 33 is a fragmentary, cross-sectional view of an embodiment of handle assemblies according to the invention.
- FIG. 34 is a cross sectional view of pusher clasp rotator of the handle assembly of FIG. 33 ;
- FIG. 35 is a plan view of the pusher clasp rotator of FIG. 34 viewed along line C-C;
- FIG. 36 is a plan and partially hidden view of the pusher clasp rotator of FIG. 34 with a helix groove for a first embodiment of the handle assembly of FIGS. 10 , 11 , and 18 ;
- FIG. 37 is a cross-sectional view of the pusher clasp rotator of FIG. 36 along section line A-A;
- FIG. 38 is a plan and partially hidden view of the pusher clasp rotator of FIG. 36 ;
- FIG. 39 is a cross-sectional view of the pusher clasp rotator of FIG. 38 along section line B-B;
- FIG. 40 is a perspective view of a rotator body of the handle assembly of FIG. 33 ;
- FIG. 41 is an elevational and partially hidden side view of the rotator body of FIG. 40 ;
- FIG. 42 is a cross-sectional view of the rotator body of FIG. 41 along section line A-A;
- FIG. 43 is an elevational and partially hidden side view of the rotator body of FIG. 40 ;
- FIG. 44 is an elevational and partially hidden side view of a pusher clasp body of the handle assembly of FIG. 33 ;
- FIG. 45 is a cross-sectional view of the pusher clasp body of FIG. 44 along section line A-A;
- FIG. 46 is a cross-sectional view of the pusher clasp body of FIG. 44 along section line B-B;
- FIG. 47 is a fragmentary, side elevational view of a portion of the handle assembly of FIG. 33 with a sheath assembly according to the invention.
- FIG. 48 is an exploded side elevational view of a portion of the handle assembly of FIG. 47 ;
- FIG. 49 is a fragmentary elevational and partially hidden side view of a handle body of the handle assembly of FIG. 33 ;
- FIG. 50 is a fragmentary, exploded side elevational view of a portion of a second embodiment of the handle assembly according to the invention.
- FIG. 51 is a fragmentary, side elevational view of the portion of FIG. 50 in a neutral position
- FIG. 52 is an exploded view of a first portion of the second embodiment of the handle assembly
- FIG. 53 is a fragmentary, exploded view of a larger portion of the second embodiment of the handle assembly as compared to FIG. 52 with the first portion and the sheath assembly;
- FIG. 54 is perspective view of a clasp body of the second embodiment of the handle assembly
- FIG. 55 is an elevational side view of the clasp body of FIG. 54 ;
- FIG. 56 is a cross-sectional view of the clasp body of FIG. 55 along section line A-A;
- FIG. 57 is a plan view of the clasp body of FIG. 54 ;
- FIG. 58 is a plan view of the clasp body of FIG. 57 viewed from section line B-B;
- FIG. 59 is a fragmentary and partially hidden side elevational view of a clasp sleeve of the second embodiment of the handle assembly
- FIG. 60 is a fragmentary, cross-sectional view of a portion the clasp sleeve of FIG. 59 along section line A;
- FIG. 61 is a fragmentary, cross-sectional view of the clasp sleeve of FIG. 59 along section line C-C;
- FIG. 62 is a fragmentary and partially hidden side elevational view of the clasp sleeve of FIG. 59 rotated with respect to FIG. 59 ;
- FIG. 63 is a fragmentary, cross-sectional view of the nose cone and sheath assemblies of FIG. 10 .
- the present invention provides a stent graft and delivery system that treats, in particular, thoracic aortic defects from the brachiocephalic level of the aortic arch distally to a level just superior to the celiac axis and provides an endovascular foundation for an anastomosis with the thoracic aorta, while providing an alternative method for partial/total thoracic aortic repair by excluding the vessel defect and making surgical repair of the aorta unnecessary.
- the stent graft of the present invention is not limited to use in the aorta. It can be endoluminally inserted in any accessible artery that could accommodate the stent graft's dimensions.
- the stent graft according to the present invention provides various features that, heretofore, have not been applied in the art and, thereby, provide a vessel repair device that implants/conforms more efficiently within the natural or diseased course of the aorta, decreases the likelihood of vessel puncture, and increases the blood-tight vascular connection, and decreases the probability of graft mobility.
- the stent graft is implanted endovascularly before or during or in place of an open repair of the vessel (i.e., an arch, in particular, the ascending and/or descending portion of the aorta) through a delivery system described in detail below.
- the typical defects treated by the stent graft are aortic aneurysms, aortic dissections, and other diseases such as penetrating aortic ulcer, coarctation, and patent ductus arteriosus, related to the aorta.
- the stent graft forms a seal in the vessel and automatically affixes itself to the vessel with resultant effacement of the pathological lesion.
- FIG. 1 there is shown an improved stent graft 1 having a graft sleeve 10 and a number of stents 20 .
- These stents 20 are, preferably, made of nitinol, an alloy having particularly special properties allowing it to rebound to a set configuration after compression, the rebounding property being based upon the temperature at which the alloy exists.
- nitinol and its application with regard to stents see, e.g., U.S. Pat. Nos. 4,665,906, 5,067,957, and 5,597,378 to Jervis and to Gianturco.
- the graft sleeve 10 is cylindrical in shape and is made of a woven graft material along its entire length.
- the graft material is, preferably, polyester, in particular, polyester referred to under the name DACRON® or other material types like Expanded Polytetrafluoroethylene (“EPTFE”), or other polymeric based coverings.
- the tubular graft sleeve 10 has a framework of individual lumen-supporting wires each referred to in the art as a stent 20 . Connection of each stent 20 is, preferably, performed by sewing a polymeric (nylon, polyester) thread around an entirety of the stent 20 and through the graft sleeve 10 .
- the stitch spacings are sufficiently close to prevent any edge of the stent 20 from extending substantially further from the outer circumference of the graft sleeve 10 than the diameter of the wire itself.
- the stitches Preferably, have a 0.5 mm to 5 mm spacing.
- the stents 20 are sewn either to the exterior or interior surfaces of the graft sleeve 10 .
- FIG. 1 illustrates all stents 20 , 30 on the exterior surface 16 of the graft sleeve 10 .
- the most proximal 23 and distal stents and a bare stent 30 are connected to the interior surface of the graft sleeve 10 and the remainder of the stents 20 are connected to the exterior surface 16 .
- Another possible non-illustrated embodiment alternates connection of the stents 20 , 30 to the graft sleeve 10 from the graft exterior surface to the graft interior surface, the alternation having any periodic sequence.
- a stent 20 when connected to the graft sleeve 10 , radially forces the graft sleeve 10 open to a predetermined diameter D.
- the released radial force creates a seal with the vessel wall and affixes the graft to the vessel wall when the graft is implanted in the vessel and is allowed to expand.
- the stents 20 are sized to fully expand to the diameter D of the fully expanded graft sleeve 10 .
- a characteristic of the present invention is that each of the stents 20 and 30 has a diameter larger than the diameter D of the fully expanded graft sleeve 10 .
- Such pre-compression is applied (1) to ensure that the graft covering is fully extended, (2) to ensure sufficient stent radial force to make sure sealing occurs, (3) to affix the stent graft and prevent it from kinking, and (4) to affix the stent graft and prevent migration.
- each of the stents 20 is formed with a single nitinol wire.
- biocompatible materials for example, stainless steel, biopolymers, cobalt chrome, and titanium alloys.
- each stent 20 corresponds to what is referred in the art as a Z-stent, see, e.g., Gianturco (although the shape of the stents 20 can be in any form that satisfies the functions of a self-expanding stent).
- the wire forming the stent 20 is a ring having a wavy or sinusoidal shape.
- an elevational view orthogonal to the center axis 21 of the stent 20 reveals a shape somewhere between a triangular wave and a sinusoidal wave as shown in FIG. 2 .
- the view of FIG. 2 shows that the stents 20 each have alternating proximal 22 and distal 24 apices.
- the apices have a radius r that does not present too great of a point towards a vessel wall to prevent any possibility of puncturing the vessel, regardless of the complete circumferential connection to the graft sleeve 10 .
- the radius r of curvature of the proximal 22 and distal 24 apices of the stent 20 are, preferably, equal.
- the radius of curvature r is between approximately 0.1 mm and approximately 3.0 mm, in particular, approximately 0.5 mm.
- Another advantageous feature of a stent lies in extending the longitudinal profile along which the stent contacts the inner wall of a vessel. This longitudinal profile can be explained with reference to FIGS. 3 to 7 .
- Prior art stents and stents according to the present invention are formed on mandrels 29 , 29 ′ by winding the wire around the mandrel 29 , 29 ′ and forming the apexes 22 , 24 , 32 , 34 by wrapping the wire over non-illustrated pins that protrude perpendicular from the axis of the mandrel. Such pins, if illustrated, would be located in the holes illustrated in the mandrels 29 , 29 ′ of FIGS. 4 and 6 .
- Prior art stents are formed on a round mandrel 29 (also referred to as a bar).
- a stent 20 ′ formed on a round mandrel 29 has a profile that is rounded (see FIG.
- the stent 20 ′ does not conform evenly against the inner wall of the vessel 2 in which it is inserted. This disadvantage is critical in the area of stent graft 1 seal zones—areas where the ends of the graft 10 need to be laid against the inner wall of the vessel 2 .
- Clinical experience reveals that stents 20 ′ formed with the round mandrel 29 do not lie against the vessel 2 ; instead, only a mid-section of the stent 20 ′ rests against the vessel 2 , as shown in FIG. 5 .
- the graft material flares away from the wall of the vessel 2 into the lumen—a condition that is to be avoided.
- An example of this flaring can be seen by comparing the upper and lower portions of the curved longitudinal profile of the stent 20 ′ in FIG. 5 with the linear longitudinal profile of the vessel 2 .
- stents 20 of the present invention are formed on a multiple-sided mandrel.
- the stents 20 are formed on a polygonal-shaped mandrel 29 ′.
- the mandrel 29 ′ does not have sharp edges. Instead, it has flat sections and rounded edge portions between the respective flat sections.
- a stent formed on the mandrel 29 ′ will have a cross-section that is somewhat round but polygonal, as shown in FIG. 3 .
- the cross-sectional view orthogonal to the center axis 21 of such a stent 20 will have beveled or rounded edges 31 (corresponding to the rounded edge portions of the mandrel 29 ′) disposed between flat sides or struts 33 (corresponding to the flat sections of the mandrel 29 ′).
- the apices remain on the circumference of the graft and do not bend into the graft interior like prior art stents—an undesirable condition as explained in the preceding paragraph.
- the struts of the stents so manufactured lie in the plane of the graft material when attached thereto as shown in FIG. 7 .
- substantially linear means that the struts are sufficiently straight and level to substantially prevent displacement of an apex (which lies between two adjacent struts) towards the interior of the graft material to which the struts and apices are attached.
- apexes of the stents 20 are formed by winding the wire over non-illustrated pins located on the rounded portions of the mandrel 29 ′.
- the struts 33 lying between the apexes 22 , 24 , 32 , 34 of the stents 20 lie flat against the flat sides of the mandrel 29 ′.
- the longitudinal profile is substantially less rounded than the profile of stent 20 ′ and, in practice, is substantially linear
- the stents 20 are formed on a dodecahedron-shaped mandrel 29 ′ (a mandrel having twelve sides), which mandrel 29 ′ is shown in FIG. 6 .
- a stent 20 fowled on such a mandrel 29 ′ will have the cross-section illustrated in FIG. 3 .
- the fourteen-apex stent 20 shown in FIG. 7 illustrates a stent 20 that has been formed on a fourteen-sided mandrel.
- the stent 20 in FIG. 7 is polygonal in cross-section (having fourteen sides) and, as shown in FIG. 7 , has a substantially linear longitudinal profile.
- the linear longitudinal profile improves the stent's 20 ability to conform to the vessel 2 and press the graft sleeve 10 outward in the sealing zones at the extremities of the individual stent 20 .
- Another way to improve the performance of the stent graft 1 is to provide the distal-most stent 25 on the graft 10 (i.e., downstream) with additional apices and to give it a longer longitudinal length (i.e., greater amplitude) and/or a longer circumferential length.
- the stent graft 1 will perform better clinically.
- the improvement, in part, is due to a need for the distal portion of the graft material 10 to be pressed firmly against the wall of the vessel.
- each of the stents 20 and 30 has a diameter larger than the diameter D of the fully expanded graft sleeve 10 .
- the distal stent 25 also has a diameter larger than the diameter D, it will impart a greater radial bias on all 360 degrees of the corresponding section of the graft than stents not having such an oversized configuration.
- a typical implanted stent graft 1 typically does not experience a lifting off at straight portions of a vessel because the radial bias of the stents acting upon the graft sleeve give adequate pressure to align the stent and graft sleeve with the vessel wall.
- a typical stent graft is implanted in a curved vessel (such as the aorta)
- the distal end of the stent graft 1 does experience a lift off from the vessel wall.
- the increased apposition and sealing of the stent graft 1 according to the present invention substantially decreases the probability of lift off because the added height and additional apices enhance the alignment of the stent graft perpendicular to the vessel wall as compared to prior art stent grafts (no lift off occurs).
- the number of total apices of a stent is dependent upon the diameter of the vessel in which the stent graft 1 is to be implanted. Vessels having a smaller diameter have a smaller total number of apices than a stent to be implanted in a vessel having a larger diameter. Table 1 below indicates preferred stent embodiments for vessels having different diameters.
- a preferred diameter of the graft sleeve 10 is 30 mm.
- the intermediate stents 20 will have 5 apices on each side (proximal and distal) for a total of 10 apices.
- the stent defines 5 periodic “waves.”
- the distal-most stent 25 in comparison, defines 6 periodic “waves” and, therefore, has 12 total apices. It is noted that the distal-most stent 25 in FIG. 1 does not have the additional apex. While Table 1 indicates preferred embodiments, these configurations can be adjusted or changed as needed.
- an exposed or bare stent 30 is provided on the stent graft 1 , preferably, only at the proximal end 12 of the graft sleeve 10 —proximal meaning that it is attached to the portion of the graft sleeve 10 from which the blood flows into the sleeve, i.e., blood flows from the bare stent 30 and through the sleeve 10 to the left of FIG. 1 .
- the bare stent 30 is not limited to being attached at the proximal end 12 .
- Another non-illustrated bare stent can be attached similarly to the distal end 14 of the graft sleeve 10 .
- the bare stent 30 is fixed to the graft sleeve 10 only at the distal apices 34 of the bare stent 30 .
- the bare stent 30 is partially free to extend the proximal apices 32 away from the proximal end of the graft sleeve 10 .
- the bare stent 30 has various properties, the primary one being to improve the apposition of the graft material to the contour of the vessel wall and to align the proximal portion of the graft covering in the lumen of the arch and provide a blood-tight closure of the proximal end 12 of the graft sleeve 10 so that blood does not pass between the vascular inside wall and outer surface 16 of the sleeve 10 (endoleak).
- the preferred configuration for the radius of curvature a of the distal apices 34 is substantially equal to the radius r of the proximal 22 and distal 24 apices of the stent 20 , in particular, it is equal at least to the radius of curvature r of the proximal apices of the stent 20 directly adjacent the bare stent 30 .
- a distance between the proximal apices 22 of the most proximal stent 23 and crossing points of the exposed portions of the bare stent 30 are substantially at a same distance from one another all the way around the circumference of the proximal end 12 of the graft sleeve 10 .
- this distance varies based upon the graft diameter. Accordingly, the sinusoidal portion of the distal apices 34 connected to the graft sleeve 10 traverse substantially the same path as that of the stent 23 closest to the bare stent 30 . Thus, the distance d between the stent 22 and all portions of the bare stent 30 connected to the graft sleeve 10 remain constant.
- Such a configuration is advantageous because it maintains the symmetry of radial force of the device about the circumference of the vessel and also aids in the synchronous, simultaneous expansion of the device, thus increasing apposition of the graft material to the vessel wall to induce a proximal seal—and substantially improve the proximal seal—due to increasing outward force members in contact with the vessel wall.
- Inter-positioning the stents 23 , 30 in phase with one another creates an overlap, i.e., the apices 34 of the bare stent 30 are positioned within the troughs of the stent 23 .
- a further advantage of such a configuration is that the overlap provides twice as many points of contact between the proximal opening of the graft 10 and the vessel in which the stent graft 1 is implanted. The additional apposition points keep the proximal opening of the graft sleeve 10 open against the vessel wall, which substantially reduces the potential for endoleaks.
- the overlap of the stents 23 , 30 increases the radial load or resistance to compression, which functionally increases fixation and reduces the potential for device migration.
- the radius of curvature ⁇ of the proximal apices 32 is significantly larger than the radius of curvature ⁇ of the distal apices 34 .
- a preferred configuration for the bare stent apices has a radius approximately equal, to 1.5 mm for the proximal apices 32 and approximately equal to 0.5 mm for the distal apices 34 .
- Such a configuration substantially prevents perforation of the blood vessel by the proximal apices 32 , or, at a minimum, makes is much less likely for the bare stent 30 to perforate the vessel because of the less-sharp curvature of the proximal apices 32 .
- the bare stent 30 also has an amplitude greater than the other stents 20 .
- the peak-to-peak amplitude of the stents 20 is approximately 1.3 cm to 1.5 cm, whereas the peak-to-peak amplitude of the bare stent 30 is approximately 2.5 cm to 4.0 cm. Accordingly, the force exerted by the bare stent 30 on the inner wall of the aorta (due to the bare stent 30 expanding to its native position) is spread over a larger surface area.
- the bare stent 30 of the present invention presents a less traumatic radial stress to the interior of the vessel wall—a characteristic that, while less per square rum than an individual one of the stents 20 would be, is sufficient, nonetheless, to retain the proximal end 12 in position.
- the taller configuration of the bare stent 30 guides the proximal opening of the stent graft in a more “squared-off” manner.
- the proximal opening of the stent graft is more aligned with the natural curvature of the vessel in the area of the proximal opening.
- any stent graft placed in the vessel has the natural tendency to migrate downstream. This is especially true when the stent graft 1 has graft sleeve segments 18 with lengths defined by the separation of the stents on either end of the segment 18 , giving the stent graft 1 an accordion, concertina, or caterpillar-like shape.
- the stent graft 1 has a tendency to migrate downstream in the vessel. It is desired to have such motion be entirely prohibited.
- prior art stent grafts have provided longitudinal rods extending in a straight line from one stent to another.
- the present invention provides a longitudinal, spiraling/helical support member 40 that, while extending relatively parallel to the longitudinal axis 11 of the graft sleeve 10 , is not aligned substantially parallel to a longitudinal extent of the entirety of the stent graft 1 as done in the prior art, “Relatively parallel” is referred to herein as an extent that is more along the longitudinal axis 11 of the stent graft 1 than along an axis perpendicular thereto.
- the longitudinal support member 40 has a somewhat S-turn shape, in that, a proximal portion 42 is relatively parallel to the axis 11 of the graft sleeve 10 at a first degree 41 (being defined as a degree of the 360 degrees of the circumference of the graft sleeve 10 ), and a distal portion 44 is, also, relatively parallel to the axis 11 of the tube graft, but at a different second degree 43 on the circumference of the graft sleeve 10 .
- the difference between the first and second degrees 41 , 43 is dependent upon the length L of the graft sleeve 10 . For an approximately 20 cm (approx.
- the second degree 43 is between 80 and 110 degrees away from the first degree 41 , in particular, approximately 90 degrees away. In comparison, for an approximately 9 cm (approx. 3.5′′) graft sleeve, the second degree 43 is between 30 and 60 degrees away from the first degree 41 , in particular, approximately 45 degrees away. As set forth below, the distance between the first and second degrees 41 , 43 is also dependent upon the curvature and the kind of curvature that the stent graft 1 will be exposed to when in vivo.
- the longitudinal support member 40 has a curved intermediate portion 46 between the proximal and distal portions 42 , 44 .
- portion it is not intended to mean that the rod is in three separate parts (of course, in a particular configuration, a multi-part embodiment is possible).
- a preferred embodiment of the longitudinal support member 40 is a single, one-piece rod made of stainless steel, cobalt chrome, nitinol, or polymeric material that is shaped as a fully curved helix 42 , 44 , 46 without any straight portion.
- the proximal and distal portions 42 , 44 can be substantially parallel to the axis 11 of the stent graft 1 and the central portion 46 can be helically curved.
- One way to describe the preferred curvature embodiment of the longitudinal support member 40 can be using an analogy of asymptotes. If there are two asymptotes extending parallel to the longitudinal axis 11 of the graft sleeve 10 at the first and second degrees 41 , 43 on the graft sleeve 10 , then the proximal portion 42 can be on the first degree 41 or extend approximately asymptotically to the first degree 41 and the distal portion 44 can be on the second degree 43 or extend approximately asymptotically to the second degree 43 . Because the longitudinal support member 40 is one piece in a preferred embodiment, the curved portion 46 follows the natural curve formed by placing the proximal and distal portions 42 , 44 as set forth herein.
- the curved longitudinal support member 40 has a centerline 45 (parallel to the longitudinal axis 11 of the graft sleeve 10 halfway between the first and second degrees 41 , 43 on the graft sleeve 10 ).
- the curved portion intersects the centerline 45 at approximately 20 to 40 degrees in magnitude, preferably at approximately 30 to 35 degrees.
- the portion of the longitudinal support member 40 between the first degree 41 and the centerline 45 is approximately a mirror image of the portion of the longitudinal support member 40 between the second degree 43 and the centerline 45 , but rotated 180 degrees around an axis orthogonal to the centerline 45 .
- Such symmetry can be referred to herein as “reverse-mirror symmetrical.”
- the longitudinal support member 40 is, preferably, sewn to the graft sleeve 10 in the same way as the stents 20 . However, the longitudinal support member 40 is not sewn directly to any of the stents 20 in the proximal portions of the graft. In other words, the longitudinal support member 40 is independent of the proximal skeleton formed by the stents 20 . Such a configuration is advantageous because an independent proximal end creates a gimbal that endows the stent graft with additional flexibility. Specifically, the gimbaled proximal end allows the proximal end to align better to the proximal point of apposition, thus reducing the chance for endoleak.
- the longitudinal support member 40 is pre-formed in the desired spiral/helical shape (counter-clockwise from proximal to distal), before being attached to the graft sleeve 10 .
- the curved shape of the longitudinal support member 40 eliminates at least a majority, or substantially all, of this disadvantage because the longitudinal support member's 40 natural shape is curved and, therefore, imparts less of a force, or none at all, to straighten the longitudinal support member 40 , and, thereby, move the implanted stent graft in an undesirable way.
- the curved longitudinal support member 40 negates the effect of the latent kinetic force residing in the aortic wall that is generated by the propagation of the pulse wave and systolic blood pressure in the cardiac cycle, which is, then, released during diastole.
- the longitudinal support member 40 can be curved in a patient-customized way to accommodate the anticipated curve of the actual vessel in which the graft will be implanted.
- the distance between the first and second degrees 41 , 43 will be dependent upon the curvature and the kind of curvature that the stent graft 1 will be exposed to when in vivo.
- the curved longitudinal support member 40 will, actually, exhibit an opposite force against any environment that would alter its conformance to the shape of its resident vessel's existing course(es).
- the support member 40 is sewn, in a similar manner as the stents 20 , on the outside surface 16 of the graft sleeve 10 .
- each end of the longitudinal support member 40 of the present invention does not end abruptly. Instead, each end of the longitudinal support member loops 47 back upon itself such that the end of the longitudinal support member along the axis of the stent graft is not sharp and, instead, presents an exterior of a circular or oval shape when viewed from the ends 12 , 14 of the graft sleeve 10 .
- Such a configuration substantially prevents the possibility of tearing the vessel wall and also provides additional longitudinal support at the oval shape by having two longitudinally extending sides of the oval 47 .
- the end of the longitudinal support member may be connected to the second proximal stent 28 and to the most distal stent. This configuration would allow the longitudinal support member to be affixed to stent 28 (see FIG. 1 ) and the most distal stent for support while still allowing for the gimbaled feature of the proximal end of the stent graft to be maintained.
- a significant feature of the longitudinal support member 40 is that the ends of the longitudinal support member 40 may not extend all the way to the two ends 12 , 14 of the graft sleeve 10 . Instead, the longitudinal support member 40 terminates at or prior to the second-to-last stent 28 at the proximal end 12 , and, if desired, prior to the second-to-last stent 28 ′ at the distal end 14 of the graft sleeve 10 .
- Such an ending configuration (whether proximal only or both proximal and distal) is chosen for a particular reason—when the longitudinal support member 40 ends before either of the planes defined by cross-sectional lines 52 , 52 ′, the sleeve 10 and the stents 20 connected thereto respectively form gimbaled portions 50 , 50 ′.
- the moving portions 50 , 50 ′ can be oriented at any angle ⁇ about the center of the circular opening in all directions (360 degrees), as shown in FIG. 8 .
- the natural gimbal thus, allows the ends 50 , 50 ′ to be inclined in any radial direction away from the longitudinal axis 11 .
- the gimbaled ends 50 , 50 ′ allow each end opening to dynamically align naturally to the curve of the vessel in which it is implanted.
- a significant advantage of the gimbaled ends 50 , 50 ′ is that they limit propagation of the forces acting upon the separate parts. Specifically, a force that, previously, would act upon the entirety of the stent graft 1 , in other words, both the end portions 50 , 50 ′ and the middle portion of the stent graft 1 (i.e., between planes 52 , 52 ′), now principally acts upon the portion in which the force occurs.
- a force that acts only upon one of the end portions 50 , 50 ′ substantially does not propagate into the middle portion of the stent graft 1 (i.e., between planes 52 , 52 ′). More significantly, however, when a force acts upon the middle portion of the stent graft 1 (whether moving longitudinally, axially (dilation), or in a torqued manner), the ends 50 , 50 ′, because they are gimbaled, remain relatively completely aligned with the natural contours of the vessel surrounding the respective end 50 , 50 ′ and have virtually none of the force transferred thereto, which force could potentially cause the ends to grate, rub, or shift from their desired fixed position in the vessel. Accordingly, the stent graft ends 50 , 50 ′ remain fixed in the implanted position and extend the seating life of the stent graft 1 .
- the longitudinal support member 40 increases the columnar strength of the graft stent 1 .
- the material of the graft sleeve can be compressed easily along the longitudinal axis 11 , a property that remains true even with the presence of the stents 20 so long as the stents 20 are attached to the graft sleeve 10 with a spacing between the distal apices 24 of one stent 20 and the proximal apices 22 of the next adjacent stout 20 . This is especially true for the amount of force imparted by the flow of blood along the extent of the longitudinal axis 11 .
- longitudinal strength of the stent graft 1 increases to overcome the longitudinal forces imparted by blood flow.
- Another benefit imparted by having such increased longitudinal strength is that the stent graft 1 is further prevented from migrating in the vessel because the tube graft is not compressing and expanding in an accordion-like manner—movement that would, inherently, cause graft migration.
- a further measure for preventing migration of the stent graft 1 is to equip at least one of any of the individual stents 20 , 30 or the longitudinal support member 40 with protuberances 60 , such as barbs or hooks ( FIG. 3 ). See, e.g., United States Patent Publication 2002/0052660 to Greenhalgh.
- the stents 20 , 30 are secured to the outer circumferential surface 16 of the graft sleeve 10 . Accordingly, if the stents 20 (or connected portions of stent 30 ) have protuberances 60 protruding outwardly, then such features would catch the interior wall of the vessel and add to the prevention of stout graft 1 migration.
- Such an embodiment can be preferred for aneurysms but is not preferred for the fragile characteristics of dissections because such protuberances 60 can excoriate the inner layer(s) of the vessel and cause leaks between layers, for example.
- the stent graft 1 is not limited to a single graft sleeve 10 .
- the entire stent graft can be a first stent graft 100 having all of the features of the stent graft 1 described above and a second stent graft 200 that, instead of having a circular extreme proximal end 12 , as set forth above, has a proximal end 212 with a shape following the contour of the most proximal stent 220 and is slightly larger in circumference than the distal circumference of the first stent graft 100 .
- proximal end 212 of the second stent graft 200 into the distal end 114 of the first stent graft 100 results, in total, in a two-part stent graft.
- first stent graft 100 fit inside the second stent graft 200 to prevent blood from leaking out therebetween. This configuration can be achieved by implanting the devices in reverse order (first implant graft 200 and, then, implant graft 100 .
- Each of the stent grafts 100 , 200 can have its own longitudinal support member 40 as needed.
- the prior art includes many different systems for endoluminally delivering a prosthesis, in particular, a stent graft, to a vessel.
- Many of the delivery systems have similar parts and most are guided along a guidewire that is inserted, typically, through an insertion into the femoral artery near a patient's groin prior to use of the delivery system.
- the delivery system is coaxially connected to the guidewire and tracks the course of the guidewire up to the aorta.
- the parts of the delivery system that will track over the wire are, therefore, sized to have an outside diameter smaller than the inside diameter of the femoral artery of the patient.
- the delivery system components that track over the guidewire include the stent graft and are made of a series of coaxial lumens referred to as catheters and sheaths.
- the stent graft is constrained, typically, by an outer catheter, requiring the stent graft to be compressed to fit inside the outer catheter. Doing so makes the portion of the delivery system that constrains the stent graft very stiff, which, therefore, reduces that portion's flexibility and makes it difficult for the delivery system to track over the guidewire, especially along curved vessels such as the aortic arch.
- the process of deploying the stent graft by sliding the constraining catheter off of the stent graft requires a very high amount of force, typically referred to as a deployment force.
- the catheter has to be strong enough to constrain the graft, requiring it to be made of a rigid material. If the rigid material is bent, such as when tracking into the aortic arch, the rigid material tends to kink, making it difficult if not impossible to deploy the stent graft.
- vascular prosthesis delivery systems include a tapered nose cone fixedly connected to a guidewire lumen, which has an inner diameter substantially corresponding to an outer diameter of the guidewire such that the guidewire lumen slides easily over and along the guidewire.
- a removable, hollow catheter covers and holds a compressed prosthesis in its hollow and the catheter is fixedly connected to the guidewire lumen.
- the framework can expand to its native position, preferably, a position that has a diameter at least as great as the inner diameter of the vessel wall to, thereby, tightly affix the prosthesis in the vessel.
- the catheter is entirely withdrawn from the prosthesis and, thereby, allows the prosthesis to expand to the diameter of the vessel, the prosthesis is fully expanded and connected endoluminally to the vessel along the entire extent of the prosthesis, e.g., to treat a dissection.
- the prosthesis is in contact with the vessel's proximal and distal landing zones when completely released from the catheter. At such a point in the delivery, the delivery system can be withdrawn from the patient. The prosthesis, however, cannot be reloaded in the catheter if implantation is not optimal.
- the aorta usually has a relatively straight portion in the abdominal region and in a lower part of the thoracic region. However, in the upper part of the thoracic region, the aorta is curved substantially, traversing an upside-down U-shape from the back of the heart over to the front of the heart.
- prior art delivery systems are relatively hard and inflexible (the guidewire/catheter portion of the prior art delivery systems).
- the guidewire/catheter must traverse the curved portion of the aorta, it will kink as it is curved or it will press against the top portion of the aortic curve, possibly puncturing the aorta if the diseased portion is located where the guidewire/catheter is exerting its force. Such a situation must be avoided at all costs because the likelihood of patient mortality is high.
- the prior art does not provide any way for substantially reducing the stress on the curved portion of the aorta or for making the guidewire/catheter sufficiently flexible to traverse the curved portion without causing damage to the vessel.
- the present invention provides significant features not found in the prior art that assist in placing a stent graft in a curved portion of the aorta in a way that substantially reduces the stress on the curved portion of the aorta and substantially reduces the insertion forces needed to have the compressed graft traverse the curved portion of the aorta.
- the delivery system of the present invention also has a very simple to use handle assembly.
- the handle assembly takes advantage of the fact that the inside diameter of the aorta is substantially larger that the inside diameter of the femoral arteries.
- the present invention accordingly, uses a two-stage approach in which, after the device is inserted in through the femoral artery and tracks up into the abdominal area of the aorta (having a larger diameter (see FIG. 19 ) than the femoral artery), a second stage is deployed (see FIG. 20 ) allowing a small amount of expansion of the stent graft while still constrained in a sheath; but this sheath, made of fabric/woven polymer or similar flexible material, is very flexible.
- a sheath made of fabric/woven polymer or similar flexible material
- the method for operating the delivery assembly 600 will be described first in association with FIGS. 10 , 11 , and 12 . Thereafter, the individual components will be described to allow a better understanding of how each step in the process is effected for delivering the stent graft 1 to any portion of the aorta 700 (see FIGS. 19 to 24 ), in particular, the curved portion 710 of the aorta.
- the distal end 14 of the stent graft 1 is compressed and placed into a hollow, cup-shaped, or tubular-shaped graft holding device, in particular, the distal sleeve 644 (see, e.g., FIG. 25 ).
- the proximal direction of the delivery system is that portion closest to the user/physician employing the system and the distal direction corresponds to the portion farthest away from the user/physician, i.e., towards the distal-most nose cone 632 .
- the distal sleeve 644 is fixedly connected to the distal end of the graft push lumen 642 , which lumen 642 provides an end face for the distal end 14 of the stent graft 1 .
- the distal sleeve 644 can be removed entirely.
- the proximal taper of the inner sheath 652 can provide the measures for longitudinally holding the compressed distal end of the graft 1 .
- each apex 32 of the bare stent 30 is, then, loaded into the apex capture device 634 so that the stent graft 1 is held at both its proximal and distal ends.
- the loaded distal end 14 along with the distal sleeve 644 and the graft push lumen 642 , are, in turn, loaded into the inner sheath 652 , thus, further compressing the entirety of the stent graft 1 .
- the captured bare stent 30 along with the nose cone assembly 630 (including the apex capture device 634 ), is loaded until the proximal end of the nose cone 632 rests on the distal end of the inner sheath 652 .
- the entire nose cone assembly 630 and sheath assembly 650 is, then, loaded proximally into the rigid outer catheter 660 , further compressing the stent graft 1 (resting inside the inner sheath 652 ) to its fully compressed position for later insertion into a patient. See FIG. 63 .
- the stent graft 1 is, therefore, held both at its proximal and distal ends and, thereby, is both pushed and pulled when moving from a first position (shown in FIG. 19 and described below) to a second position (shown in FIG. 21 and described below). Specifically, pushing is accomplished by the non-illustrated interior end face of the hollow distal sleeve 644 (or the taper 653 of the inner sheath 652 ) and pulling is accomplished by the hold that the apex capture device 634 has on the apices 32 of the bare stent 30 .
- the assembly 600 tracks along a guidewire 610 already inserted in the patient and extending through the aorta and up to, but not into, the left ventricle of the heart 720 . Therefore, a guidewire 610 is inserted through the guidewire lumen 620 starting from the nose cone assembly 630 , through the sheath assembly 650 , through the handle assembly 670 , and through the apex release assembly 690 . The guidewire 610 extends out the proximal-most end of the assembly 600 .
- the guidewire lumen 620 is coaxial with the nose cone assembly 630 , the sheath assembly 650 , the handle assembly 670 , and the apex release assembly 690 and is the innermost lumen of the assembly 600 immediately surrounding the guidewire 610 .
- a liquid such as sterile U.S.P. saline
- saline is also injected through the luer fitting 612 of the lateral purge-port (see FIG. 11 ), which liquid fills the entire internal co-axial space of the delivery system assembly 600 . It may be necessary to manipulate the system to facilitate movement of the air to be purged to the highest point of the system.
- the system can be threaded onto the guidewire and inserted into the patient. Because the outer catheter 660 has a predetermined length, the fixed front handle 672 can be disposed relatively close to the entry port of the femoral artery. It is noted, however, that the length of the outer catheter 660 is sized such that it will not have the fixed proximal handle 672 directly contact the entry port of the femoral artery in a patient who has the longest distance between the entry port and the thoracic/abdominal junction 742 , 732 of the aorta expected in a patient (this distance is predetermined).
- the delivery assembly 600 of the present invention can be used with typical anatomy of the patient. Of course, the assembly 600 can be sized to any usable length.
- the nose cone assembly 630 is inserted into a patient's femoral artery and follows the guidewire 610 until the nose cone 632 reaches the first position at a level of the celiac axis.
- the first position is shown in FIG. 19 .
- the nose cone assembly 630 is radiopaque, whether wholly or partially, to enable the physician to determine fluoroscopically, for example, that the nose cone assembly 630 is in the first position.
- the nose cone 632 can have a radiopaque marker 631 anywhere thereon or the nose cone 632 can be entirely radiopaque.
- the locking ring 676 is placed from its neutral position N, shown in FIG. 10 , into its advancement position A, shown in FIG. 11 .
- placing the locking ring 676 into its advancement position A allows both the nose cone assembly 630 and the internal sheath assembly 650 to move as one when the proximal handle 678 is moved in either the proximal or distal directions because the locking ring 676 radially locks the graft push lumen 642 to the lumens of the apex release assembly 690 (including the guidewire lumen 620 and an apex release lumen 640 ).
- the locking ring 676 is fixedly connected to a sheath lumen 654 .
- the pusher clasp spring 298 shown in FIG. 48 and the proximal spring 606 shown in FIG. 52 are both disengaged. This allows free movement of the graft push lumen 642 with the guidewire lumen 620 and the apex release lumen 640 within the handle body 674 .
- the pusher clasp spring 298 shown in FIG. 48 is engaged and the proximal spring 606 shown in FIG. 52 is disengaged.
- the sheath lumen 654 (fixedly attached to the inner sheath 652 ) is, thereby, locked to the graft push lumen 642 (fixedly attached to the distal sleeve 644 ) so that, when the proximal handle 678 is moved toward the distal handle 672 , both the sheath lumen 654 and the graft push lumen 642 move as one.
- the graft push lumen 642 is also locked to both the guidewire lumen 620 and the apex release lumen 640 (which are locked to one another through the apex release assembly 690 as set forth in more detail below). Accordingly, as the proximal handle 678 is moved to the second position, shown with dashed lines in FIG. 11 , the sheath assembly 650 and the nose cone assembly 630 progress distally out of the outer catheter 660 as shown in FIGS. 20 and 21 and with dashed lines in FIG. 11 .
- the sheath lumen 654 needs to be withdrawn from the stent graft 1 to, thereby, expose the stent graft 1 from its proximal end 12 to its distal end 14 and, ultimately, entirely off of its distal end 14 . Therefore, movement of the locking ring 676 into the deployment position D will engage the proximal spring 606 shown in FIG. 52 and disengage the pusher clasp spring 298 shown in FIG. 48 . At this point, the graft push lumen 642 along with the guidewire lumen 620 and the apex release lumen 640 are locked to the handle body 674 so as not to move with respect to the handle body 674 .
- the sheath lumen 654 is unlocked from the graft push lumen 642 . Movement of the distal handle 678 back to the third position (proximally), therefore, pulls the sheath lumen 654 proximally, thus, proximally withdrawing the inner sheath 652 from the stent graft 1 .
- FIGS. 33 to 62 In order to explain how the locking and releasing of the lumen occur as set forth above, reference is made to FIGS. 33 to 62 .
- FIG. 33 is a cross-sectional view of the proximal handle 678 and the locking ring 676 .
- a pusher clasp rotator 292 is disposed between a clasp sleeve 614 and the graft push lumen 642 .
- a specific embodiment of the pusher clasp rotator 292 is illustrated in FIGS. 30 through 35 .
- Also disposed between the clasp rotator 292 and the graft push lumen 642 is a rotator body 294 , which is directly adjacent the graft push lumen 642 .
- a specific embodiment of the rotator body 294 is illustrated in FIGS. 40 through 43 .
- a pusher clasp body 296 Disposed between the rotator body 294 and the sheath lumen 654 is a pusher clasp body 296 , which is fixedly connected to the rotator body 294 and to the locking ring 676 .
- a specific embodiment of the pusher clasp body 296 is illustrated in FIGS. 44 through 46 .
- a pusher clasp spring 298 operatively connects the pusher clasp rotator 292 to the rotator body 294 (and, thereby, the pusher clasp body 296 ).
- FIG. 48 An exploded view of these components is presented in FIG. 48 , where an O-ring 293 is disposed between the rotator body 294 and the pusher clasp body 296 .
- a crimp ring 295 connects the sheath lumen 654 to the distal projection 297 of the pusher clasp body 296 .
- a hollow handle body 674 on which the proximal handle 678 and the locking ring 676 are slidably mounted, holds the pusher clasp rotator 292 , the rotator body 294 , the pusher clasp body 296 , and the pusher clasp spring 298 therein.
- This entire assembly is rotationally mounted to the distal handle 672 for rotating the stent graft 1 into position (see FIGS. 23 and 24 and the explanations thereof below).
- a specific embodiment of the handle body 674 is illustrated in FIG. 49 .
- a setscrew 679 extends from the proximal handle 678 to contact a longitudinally helixed groove in the pusher clasp rotator 292 (shown in FIGS. 36 and 38 ).
- the pusher clasp rotator 292 rotates clockwise or counter-clockwise.
- FIG. 50 et seq. An alternative embodiment of the locking ring 676 is shown in FIG. 50 et seq., which is the preferred embodiment because, instead of applying a longitudinal movement to rotate the pusher clasp spring 298 through the cam/follower feature of the proximal handle 678 and pusher clasp rotator 292 , a rotating locking knob 582 is located at the proximal end of the handle body 674 .
- the knob 582 has three positions that are clearly shown in FIG. 51 : a neutral position N, an advancement position A, and a deployment position D.
- the functions of these positions N, A, D correspond to the positions N, A, D of the locking ring 676 and the proximal handle 678 as set forth above.
- a setscrew 584 is threaded into the clasp sleeve 614 through a slot 675 in the handle body 674 and through a slot 583 in the knob 582 to engage the locking knob 582 . Because of the x-axis orientation of the slot 583 in the knob 582 and the y-axis orientation of the slot 675 in the handle body 674 , when the knob 582 is slid over the end of the handle body 674 and the setscrew 584 is screwed into the clasp sleeve 614 , the knob 582 is connected fixedly to the handle body 674 . When the locking knob 582 is, thereafter, rotated between the neutral N, advancement A, and deployment D positions, the clasp sleeve 614 rotates to actuate the spring lock (see FIGS. 48 and 52 ).
- a setscrew 586 engages a groove 605 in the proximal clasp assembly 604 to connect the proximal clasp assembly 604 to the clasp sleeve 614 but allows the clasp sleeve 614 to rotate around the clasp body 602 .
- the clasp sleeve 614 is shown in FIGS. 50 and 53 and, in particular, in FIGS. 59 to 62 .
- the proximal clasp assembly 604 of FIG. 53 is more clearly shown in the exploded view of FIG. 52 .
- the proximal clasp assembly 604 is made of the components including a proximal spring 606 , a locking washer 608 , a fastener 603 (in particular, a screw fitting into internal threads of the proximal clasp body 602 ), and a proximal clasp body 602 .
- the proximal clasp body 602 is shown, in particular, in FIGS. 54 through 58 .
- the proximal clasp assembly 604 is connected fixedly to the handle body 674 , preferably, with a screw 585 shown in FIG. 50 and hidden from view in FIG. 51 under knob 582 .
- the handle body 674 has a position pin 592 for engaging in position openings at the distal end of the locking knob 582 .
- the position pin 592 can be a setscrew that only engages the handle body 674 .
- the knob can be rotated clockwise or counter-clockwise to place the pin 592 into the position openings corresponding to the advancement A, neutral N, and deployment D positions.
- the user/physician grasps both the distal handle 672 and the proximal handle 678 and slides the proximal handle 678 towards the distal handle 672 in the direction indicated by arrow A.
- This movement as shown in FIGS. 19 to 21 , causes the flexible inner sheath 652 , holding the compressed stent graft 1 therein, to emerge progressively from inside the outer catheter 660 .
- Such a process allows the stent graft 1 , while constrained by the inner sheath 652 , to expand to a larger diameter as shown in FIG.
- the outer catheter 660 is made of a polymer (co-extrusions or teflons) and the inner sheath 652 is made of a material, such as a fabric/woven polymer or other similar material. Therefore, the inner sheath 652 is substantially more flexible than the outer catheter 660 .
- the inner sheath 652 contains a taper 653 at its proximal end, distal to the sheath's 652 connection to the sheath lumen 654 (at which the inner sheath 652 has a similar diameter to the distal sleeve 644 working in conjunction with the distal sleeve 644 to capture the distal end 14 of the stent graft 1 .
- the taper 653 provides a transition that substantially prevents any kinking of the outer catheter 660 when the stent graft 1 is loaded into the delivery assembly 600 (as in the position illustrated in FIGS. 10 and 11 ) and, also, when the outer catheter 660 is navigating through the femoral and iliac vessels.
- sheath lumen 654 has a length between approximately 35 and 37 inches, in particular, 36 inches, an outer diameter of between approximately 0.20 and 0.25 inches, in particular 0.238 inches, and an inner diameter between approximately, 0.18 and approximately 0.22 inches, in particular, 0.206 inches.
- the nose cone assembly 630 and the sheath assembly 650 move towards a second position where the sheath assembly 650 is entirely out of the outer catheter 660 as shown in FIGS. 20 and 21 .
- the nose cone assembly 630 and the sheath assembly 650 are emerging out of the outer catheter 660 , they are traversing the curved portion 710 of the descending aorta.
- the tracking is accomplished visually by viewing radiopaque markers on various portions of the delivery system and/or the stent graft 1 with fluoroscopic measures. Such markers will be described in further detail below.
- the delivery system can be made visible, for example, by the nose cone 630 being radiopaque or containing radiopaque materials.
- the nose cone assembly 630 and the sheath assembly 650 can be extended easily into the curved portion 710 of the aorta 700 with much less force on the handle than previously needed with prior art systems while, at the same time, imparting harmless forces to the intraluminal surface of the curved aorta 710 due to the flexibility of the inner sheath 652 .
- the user/physician uses fluoroscopic tracking of radiopaque markers (e.g., marker 631 ) on any portion of the nose cone or on the stent graft 1 and/or sheath assemblies 630 , 650 , for example, makes sure that the proximal end 112 of the stent graft 1 is in the correct longitudinal position proximal to the diseased portion 744 of the aorta 700 .
- radiopaque markers e.g., marker 631
- the physician can rotate the entire inserted assembly 630 , 650 clockwise or counterclockwise (indicated in FIG. 21 by arrow B) merely by rotating the proximal handle 678 in the desired direction.
- Such a feature is extremely advantageous because the non-rotation of the outer catheter 660 while the inner sheath 652 is rotating eliminates stress on the femoral and iliac arteries when the rotation of the inner sheath 652 is needed and performed.
- the stent graft 1 can be pre-aligned to place the stent graft 1 in the correct circumferential position—defined by placing the longitudinal support member 40 substantially at the superior longitudinal surface line of the curved aorta with respect to anatomical position).
- FIG. 23 illustrates the longitudinal support member 40 not in the correct superior position
- FIG. 24 illustrates the longitudinal support member 40 in the correct superior position.
- the superior surface position is, preferably, the longest superior longitudinal line along the circumference of the curved portion of the aorta as shown in FIGS. 23 and 24 .
- the longitudinal support member 40 when the longitudinal support member 40 extends along the superior longitudinal line of the curved aorta, the longitudinal support member 40 substantially eliminates any possibility of forming a kink in the inferior radial curve of the stent graft 1 during use and also allows transmission of longitudinal forces exerted along the inside lumen of the stent graft 1 to the entire longitudinal extent of the stent graft 1 , thereby allowing the entire outer surface of the stent graft 1 to resist longitudinal migration.
- the stent graft is, typically, provided with symmetrically-shaped radiopaque markers along one longitudinal line and at least one other symmetrically-shaped radiopaque marker disposed along another longitudinal line on the opposite side (180 degrees) of the stent graft.
- the only way to determine if the stent graft is in the correct rotational position is by having the user/physician rotate the stent graft in both directions until it is determined that the first longitudinal line is superior and the other longitudinal line is anterior. This required more work by the physician and is, therefore, undesirable.
- unique radiopaque markers 232 , 234 are positioned on the stent graft 1 to assist the user/physician in correctly positioning the longitudinal support member 40 in the correct aortic superior surface position with only one directional rotation that is also the minimal rotation needed to place the stent graft 1 in the rotationally correct position.
- the stent graft 1 is provided with a pair of symmetrically shaped but diametrically opposed markers 232 , 234 indicating to the user/physician which direction the stent graft 1 needs to be rotated to align the longitudinal support member 40 to the superior longitudinal line of the curved aorta (with respect to anatomical position).
- the markers 232 , 234 are placed at the proximate end 12 of the graft sleeve 10 on opposite sides (180 degrees) of the graft sleeve 10 .
- the angular position of the markers 232 , 234 on the graft sleeve 10 is determined by the position of the longitudinal support member 40 .
- the support member 40 is between the two markers 232 , 234 .
- the centerline 45 of the support member 40 is at a 90 degree position.
- an alternative position of the markers can place the marker 234 90 degrees away from the first degree 41 (see FIG. 1 ).
- Such a positioning is dependent somewhat upon the way in which the implantation is to be viewed by the user/physician and can be varied based on other factors.
- the position can be rotated in any beneficial way.
- Preferred ancillary equipment in endovascular placement of the stent graft 1 is a fluoroscope with a high-resolution image intensifier mounted on a freely angled C-arm.
- the C-arm can be portable, ceiling, or pedestal mounted. It is important that the C-arm have a complete range of motion to achieve AP to lateral projections without moving the patient or contaminating the sterile field. Capabilities of the C-arm should include: Digital Subtraction Angiography, High-resolution Angiography, and Roadmapping.
- the patient For introduction of the delivery system into the groin access arteries, the patient is, first, placed in a sterile field in a supine position. To determine the exact target area for placement of the stent graft 1 , the C-arm is rotated to project the patient image into a left anterior oblique projection, which opens the radial curve of the thoracic aortic arch for optimal visualization without superimposition of structures. The degree of patient rotation will vary, but is usually 40 to 50 degrees. At this point, the C-arm is placed over the patient with the central ray of the fluoroscopic beam exactly perpendicular to the target area. Such placement allows for the markers 232 , 234 to be positioned for correct placement of the stent graft 1 .
- the markers 232 , 234 are hemispherical, in other words, they have the approximate shape of a “D”. This shape is chosen because it provides special, easy-to-read indicators that instantly direct the user/physician to the correct placement position for the longitudinal support member 40 .
- FIG. 27 illustrates a plan view of the markers 232 , 234 when they are placed in the upper-most superior longitudinal line of the curved aorta, The correct position is indicated clearly because the two hemispheres have the flat diameters aligned on top of or immediately adjacent to one another such that a substantially complete circle is formed by the two hemispherically rounded portions of the markers 232 , 234 . This position is also indicated in the perspective view of FIG. 28 .
- FIGS. 27 and 28 have been provided with examples where the markers 232 , 234 are not aligned and, therefore, the stent graft 1 is not in the correct insertion position.
- two markers 232 ′, 234 ′ indicate a misaligned counter-clockwise-rotated stent graft 1 when viewed from the plane 236 at the right end of the stent graft 1 of FIG. 23 looking toward the left end thereof and down the axis 11 .
- the user/physician sees that the distance between the two flat diameters is closer than the distance between the highest points of the hemispherical curves. Therefore, it is known that the two flat diameters must be joined together by rotating the stent graft 1 clockwise.
- FIG. 28 has also been provided with two markers 232 ′′, 234 ′′ indicating a misaligned clockwise-rotated stent graft 1 when viewed from the plane 236 at the right end of the stent graft 1 of FIG. 27 looking toward the left end thereof and down the axis 11 .
- the user/physician sees that the distance between the highest points of the hemispherical curves is smaller than the distance between the two flat diameters.
- the two flat diameters must be joined together by rotating the stent graft 1 in the direction that the highest points of the hemispherical curves point; in other words, the stent graft 1 must be rotated counter-clockwise.
- a significant advantage provided by the diametrically opposed symmetric markers 232 , 234 is that they can be used for migration diagnosis throughout the remaining life of a patient after the stent graft 1 has been placed inside the patient's body. If fluoroscopic or radiographic techniques are used any time after the stent graft 1 is inserted in the patient's body, and if the stent graft 1 is viewed, from the same angle as it was viewed when placed therein, then the markers' 232 , 234 relative positions observed should give the examining individual a very clear and instantaneous determination as to whether or not the stent graft 1 has migrated in a rotational manner.
- the hemispherical shape of the markers 232 , 234 are only provided as an example shape.
- the markers 232 , 234 can be any shape that allows a user/physician to distinguish alignment and direction of rotation for alignment.
- the markers 232 , 234 can be triangular, in particular, an isosceles triangle having the single side be visibly longer or shorter than the two equal sides.
- the stent graft 1 When the stent graft 1 is in place both longitudinally and circumferentially ( FIG. 21 ), the stent graft 1 is ready to be removed from the inner sheath 652 and implanted in the vessel 700 . Because relative movement of the stent graft 1 with respect to the vessel is no longer desired, the inner sheath 652 needs to be retracted while the stent graft 1 remains in place, i.e., no longitudinal or circumferential movement. Such immovability of the stent graft 1 is insured by, first, the apex capture device 634 of the nose cone assembly 630 holding the front of the stent graft 1 by its bare stent 30 (see FIGS.
- the apex capture device 634 is holding each individual distal apex 32 of the bare stent 30 in a secure manner—both rotationally and longitudinally.
- the nose cone assembly 630 along with the apex capture device 634 , is securely attached to the guidewire lumen 620 (and the apex release lumen 640 at least until apex release occurs).
- the inner sheath 652 is securely attached to a sheath lumen 654 , which is coaxially disposed around the guidewire lumen 620 and fixedly attached to the proximal handle 678 .
- the stent graft 1 is also supported at its distal end by the graft push lumen 642 and the distal sleeve 644 or the taper 653 of the inner sheath 652 , (The entire coaxial relationship of the various lumen 610 , 620 , 640 , 642 , 654 , and 660 is illustrated for exemplary purposes only in FIG. 25 , and a portion of which can also be seen in the exploded view of the handle assembly in FIG. 50 ) Therefore, when the proximal handle 678 is moved proximally with the locking ring 676 in the deployment position D, the sheath lumen 654 moves proximally as shown in FIGS.
- the stent graft 1 is, now, ready to be finally affixed to the aorta 700 .
- the bare stent 30 must be released from the apex capture device 634 .
- the apex capture device 634 shown in FIGS. 13 , 14 , and 29 to 32 holds the proximal apices 32 of the bare stent 30 between the distal apex head 636 and the proximal apex body 638 .
- the distal apex head 636 is fixedly connected to the guidewire lumen 620 .
- the proximal apex body 638 is fixedly connected to the apex release lumen 640 , which is coaxial with both the guidewire lumen 620 and the sheath lumen 654 and disposed therebetween, as illustrated diagrammatically in FIG. 25 .
- the graft push lumen 642 is also fixedly connected to the apex release lumen 640 . Therefore, relative movement of the apex release lumen 640 and the guidewire lumen 620 separates the distal apex head 636 and a proximal apex body 638 from one another.
- the apex release assembly 690 has, in a preferred embodiment, three parts, a distal release part 692 , a proximal release part 694 , and an intermediate part 696 (which is shown in the form of a clip in FIGS. 16 and 26 ).
- the proximal release part 694 is formed with a distal surface 695
- the distal release part 692 is formed with a proximal surface 693
- the intermediate part 696 has proximal and distal surfaces corresponding to the surfaces 695 , 693 such that, when the intermediate part 696 is inserted removably between the distal surface 695 and the proximal surface 693 , the intermediate part 696 fastens the distal release part 692 and the proximal release part 694 with respect to one another in a form-locking connection.
- a form-locking connection is one that connects two elements together due to the shape of the elements themselves, as opposed to a force-locking connection, which locks the elements together by force external to the elements.
- the clip 696 surrounds a distal plunger 699 of the proximal release part 694 that is inserted slidably within a hollow 698 of the distal release part 692 .
- the plunger 699 of the proximal release part 694 can slide within the hollow 698 , but a stop 697 inside the hollow 698 prevents the distal plunger 699 from withdrawing from the hollow 698 more than the longitudinal span of the clip 696 .
- the intermediate part 696 is removed easily with one hand and, as shown from the position in FIG. 16 to the position in FIG. 17 , the distal release part 692 and the proximal release part 694 are moved axially towards one another (preferably, the former is moved towards the latter).
- Such movement separates the distal apex head 636 and the proximal apex body 638 as shown in FIG. 14 . Accordingly, the distal apices 32 of the bare stent 30 are free to expand to their natural position in which the bare stent 30 is released against the vessel 700 .
- the apex release assembly 690 can be formed with any kind of connector that moves the apex release lumen 640 and the guidewire lumen 620 relative to one another.
- the intermediate part 696 can be a selectable lever that is fixedly connected to either one of the distal release part 692 or the proximal release part 694 and has a length equal to the width of the clip 696 shown in FIG. 26 .
- the parts 692 , 694 when engaged by pivoting the lever between the distal release part 692 and the proximal release part 694 , for example, the parts 692 , 694 cannot move with respect to one another and, when disengaged by pivoting the lever out from between the parts 692 , 694 , the distal release part 692 and the proximal release part 694 are free to move towards one another.
- the apex clasp device is unique to the present invention in that it incorporates features that allow the longitudinal forces subjected on the stent graft 1 to be fully supported, through the bare stent 30 , by both the guidewire lumen 620 and apex release lumen 640 .
- Support occurs by providing the distal apex head 636 with a distal surface 639 supporting the proximal apices 32 of the bare stent 30 , which is particularly shown in the enlarged perspective view of the distal apex head 636 provided in FIG. 29 .
- the distal surface 639 rests on the proximal apex body 638 when in the closed position, as more clearly shown in FIGS. 30 and 31 .
- the longitudinal forces are fully transmitted to both the guidewire lumen 620 and apex release lumen 640 , making the assembly much stronger.
- Having the distal surface 639 be the load-bearing surface of the proximal apices 32 ensures expansion of the each one of the distal apices 32 from the apex release assembly 690 .
- the proximal surface 641 of the distal apex head 636 meets with the interior surfaces of the proximal apex body 638 to help carry the apex load because the apices of the bare stent 30 are captured therebetween when the apex capture device 634 is closed. Such capture can be clearly seen in the cut-away view of the proximal apex body 638 in FIG. 31 .
- the proximal apex body 638 moves to the left (with respect to FIG. 32 ). Because of friction occurring between the apices 32 and the “teeth” of the proximal apex body 638 when the apices 32 are captured, the apices 32 will also try to move to the left along with the proximal apex body 638 and, if allowed to do so, possibly would never clear the “teeth” to allow each apex 32 to expand. However, as the proximal apex body 638 disengages (moves in the direction of arrow C in FIG.
- tapers on the distal outer surfaces of the proximal apex body 638 further assist in the prevention of catching the proximal apices 32 of the bare stent 30 on any part of the apex capture device 634 .
- the apex capture device 634 provides support for load placed on the stent graft 1 during advancement A of the inner sheath 652 and during withdrawal of the inner sheath 652 (i.e., during deployment D).
- Such a configuration benefits the apposition of the bare stent 30 by releasing the bare stent 30 after the entire graft sleeve 10 has been deployed, thus reducing the potential for vessel perforation at the point of initial deployment.
- the proximal handle 678 is, then, substantially at or near the third position (deployment position) shown in FIG. 10 .
- the stent graft 1 is, now, securely placed within the vessel and the entire portion 630 , 650 , 660 of the assembly 600 may be removed from the patient.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Cardiology (AREA)
- Pulmonology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biophysics (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Prostheses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
Abstract
Elastic compressible stents have a plurality of proximal and distal apices joined by struts that are essentially straight. The stent can have a polygonal cross-sectional shape, such as a dodecahedron shape. Elastic compressible stents can be made by a method that includes winding stent wire around an outer surface of a longitudinal axis of a polygonal cross-sectional shaped mandrel into a desired shape that is polygonal in an elevation orthogonal to the longitudinal axis. The stent can be formed by setting the wound stent wire in the desired polygonal final shape. The polygonal cross-sectional shape mandrel can be a mandrel having a multi-sided outer surface. Stents can include graft material attached to the stent.
Description
- This application is a divisional of co-pending U.S. patent application Ser. No. 10/784,462, filed Feb. 23, 2004, which application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Applications Nos. 60/499,652, filed Sep. 3, 2003, and 60/500,155, filed Sep. 4, 2003, the complete disclosures of which are each hereby incorporated by reference herein in their entirety.
- 1. Field of the Invention
- The invention lies in the field of endoluminal blood vessel repairs. The invention specifically relates to a method for making a non-circular stent, which can be used to endoluminally repair aneurysm and/or dissections of the thoracic transverse aortic arch, thoracic posterior aortic arch, and the descending thoracic portion of the aorta.
- 2. Description of the Related Art
- A stent graft is an implantable device made of a tube-shaped surgical graft covering and an expanding or self-expanding frame. The stent graft is placed inside a blood vessel to bridge, for example, an aneurismal, dissected, or other diseased segment of the blood vessel, and, thereby, exclude the hemodynamic pressures of blood flow from the diseased segment of the blood vessel.
- In selected patients, a stent graft advantageously eliminates the need to perform open thoracic or abdominal surgical procedures to treat diseases of the aorta and eliminates the need for total aortic reconstruction. Thus, the patient has less trauma and experiences a decrease in hospitalization and recovery times. The time needed to insert a stent graft is substantially less than the typical anesthesia time required for open aortic bypass surgical repair, for example.
- Use of surgical and/or endovascular grafts have widespread use throughout the world in vascular surgery. There are many different kinds of vascular graft configurations. Some have supporting framework over their entirety, some have only two stents as a supporting framework, and others simply have the tube-shaped graft material with no additional supporting framework, an example that is not relevant to the present invention.
- One of the most commonly known supporting stent graft frameworks is that disclosed in U.S. Pat. Nos. 5,282,824 and 5,507,771 to Gianturco (hereinafter collectively referred to as “Gianturco”). Gianturco describes a zig-zag-shaped, self-expanding stent commonly referred to as a z-stent. The stents are, preferably, made of nitinol, but also have been made from stainless steel and other biocompatible materials.
- There are various features characterizing a stent graft. The first significant feature is the tube of graft material. This tube is commonly referred to as the graft and forms the tubular shape that will, ultimately, take the place the diseased portion of the blood vessel. The graft is, preferably, made of a woven sheet (tube) of polyester or PTFE. The circumference of the graft tube is, typically, at least as large as the diameter and/or circumference of the vessel into which the graft will be inserted so that there is no possibility of blood flowing around the graft (also referred to as endoleak) to either displace the graft or to reapply hemodynamic pressure against the diseased portion of the blood vessel. Accordingly, to so hold the graft, self-expanding frameworks are attached typically to the graft material, whether on the interior or exterior thereof. Because blood flow within the lumen of the graft could be impaired if the framework was disposed on the interior wall of the graft, the framework is connected typically to the exterior wall of the graft. The ridges formed by such an exterior framework help to provide a better fit in the vessel by providing a sufficiently uneven outer surface that naturally grips the vessel where it contacts the vessel wall and also provides areas around which the vessel wall can endothelialize to further secure the stent graft in place.
- One of the significant dangers in endovascular, graft technology is the possibility of the graft migrating from the desired position in which it is installed. Therefore, various devices have been created to assist in anchoring the graft to the vessel wall.
- One type of prior art prosthetic device is a stent graft made of a self-expanding metallic framework. For delivery, the stent graft is, first, radially compressed and loaded into an introducer system that will deliver the device to the target area. When the introducer system holding the stent graft positioned in an appropriate location in the vessel and allowed to open, the radial force imparted by the self-expanding framework is helpful, but, sometimes, not entirely sufficient, in endoluminally securing the stent graft within the vessel.
- U.S. Pat. No. 5,824,041 to Lenker et al. (hereinafter “Lenker”) discloses an example of a stein graft delivery system. Lenker discloses various embodiments in which a sheath is retractable proximally over a prosthesis to be released, With regard to
FIGS. 7 and 8 , Lenker names components 72 and 76, respectively, as “sheath” and “prosthesis-containment sheath.” However, the latter is merely the catheter in which the prosthesis 74 and the sheath 72 are held. With regard toFIGS. 9 and 10 , the sheath 82 has inner and outer layers 91, 92 fluid-tightly connected to one another to form a ballooning structure around the prosthesis P. This ballooning structure inflates when liquid is inflated with, a non-compressible fluid medium and flares radially outward when inflated. With regard toFIGS. 13 to 15 , Lenker discloses the “sheath” 120, which is merely the delivery catheter, and an eversible membrane 126 that “folds back over itself (everts) as the sheath 120 is retracted so that there are always two layers of the membrane between the distal end of the sheath [120] and the prosthesis P.” Lenker at col. 9, lines 63 to 66. The eversion (peeling back) is caused by direct connection of the distal end 130 to the sheath 120. The Lenker delivery system shown inFIGS. 19A to 19D holds the prosthesis P at both ends 256, 258 while an outer catheter 254 is retracted over the prosthesis P and the inner sheath 260. The inner sheath 260 remains inside the outer catheter 254 before, during, and after retraction. Another structure for holding the prosthesis P at both ends is illustrated inFIGS. 23A and 23B . Therein, the proximal holder having resilient axial members 342 is connected to a proximal ring structure 346.FIGS. 24A to 24C also show an embodiment for holding the prosthesis at both ends inside thin-walled tube 362. - To augment radial forces of stents, some prior art devices have added proximal and/or distal stents that are not entirely covered by the graft material. By not covering with graft material a portion of the proximal/distal ends of the stent, these stents have the ability to expand further radially than those stents that are entirely covered by the graft material. By expanding further, the proximal/distal stent ends better secure to the interior wall of the vessel and, in doing so, press the extreme cross-sectional surface of the graft ends into the vessel wall to create a fixated blood-tight seal.
- One example of such a prior art exposed stent can be found in United States Patent Publication US 2002/0198587 to Greenberg et al. The modular stent graft assembly therein has a three-part stent graft: a two-part graft having an
aortic section 12 and an iliac section 14 (with four sizes for each) and a contralateral iliac occluder 80.FIGS. 1 , 2, and 4 to 6 show theattachment stent 32. As illustrated inFIGS. 1 , 2, and 4, theattachment stent 32, while rounded, is relatively sharp and, therefore, increases the probability of puncturing the vessel. - A second example of a prior art exposed stent can be found in U.S. Patent Publication 2003/0074049 to Hoganson et al. (hereinafter “Hoganson”), which discloses a covered
stent 10 in which the elongated portions orsections 24 of the ends 20 a and 20 b extend beyond the marginal edges of thecover 22. See Hoganson atFIGS. 1 , 3, 9, 11 a, 11 b, 12 a, 12 b, and 13. However, these extending exposed edges are triangular, with sharp apices pointing both upstream and downstream with regard to a graft placement location. Such a configuration of the exposed stent 20 a, 20 b increases the possibility of puncturing the vessel. In various embodiments shown inFIGS. 6 a, 6 b, 6 c, 10, 14 a, Hoganson teaches completely covering the extended stent and, therefore, the absence of a stent extending from thecover 22. It is noted that the Hoganson stent is implanted by inflation of a balloon catheter. - Another example of a prior art exposed stent can be found in U.S. Pat. No. 6,565,596 to White at al. (hereinafter “White I”), which uses a proximally extending stent to prevent twisting or kinking and to maintain graft against longitudinal movement. The extending stent is expanded by a balloon and has a sinusoidal amplitude greater than the next adjacent one or two sinusoidal wires. White I indicates that it is desirable to space wires adjacent upstream end of graft as close together as is possible. The stent wires of White I are actually woven into graft body by piercing the graft body at various locations. See White I at
FIGS. 6 and 7 . Thus, the rips in the graft body can lead to the possibility of the exposed stent moving with respect to the graft and of the graft body ripping further. Between the portions of the extending stent 17, the graft body has apertures. - The stent configuration of U.S. Pat. No. 5,716,393 to Lindenberg et al. is similar to White I in that the outermost portion of the one-piece stent—made from a sheet that is cut/punched and then rolled into cylinder—has a front end with a greater amplitude than the remaining body of the stent
- A further example of a prior art exposed stent can be found in U.S. Pat. No. 6,524,335 to Hartley et al. (hereinafter “Hartley”).
FIGS. 1 and 2 of Hartley particularly disclose a proximal first stent 1 extending proximally from graftproximal end 4 with both the proximal and distal apices narrowing to pointed ends. - Yet another example of a prior art exposed stent can be found in U.S. Pat. No. 6,355,056 to Pinheiro (hereinafter “Pinheiro I”). Like the Hartley exposed stent, Pinheiro discloses exposed stents having triangular, sharp proximal apices.
- Still a further example of a prior art exposed stent can be found in U.S. Pat. No. 6,099,558 to White et al. (hereinafter “White II”). The White II exposed stent is similar to the exposed stent of White I and also uses a balloon to expand the stent.
- An added example of a prior art exposed stent can be found in U.S. Pat. No. 5,871,536 to Lazarus, which discloses two support members 68 longitudinally extending from proximal end to a rounded point. Such points, however, create a very significant possibility of piercing the vessel.
- An additional example of a prior art exposed stent can be found in U.S. Pat. No. 5,851,228 to Pinheiro (hereinafter “Pinheiro II”). The Pinheiro II exposed stents are similar to the exposed stents of Pinheiro I and, as such, have triangular, sharp, proximal apices.
- Still another example of a prior art exposed stent can be found in Lenker (U.S. Pat. No. 5,824,041), which shows a squared-off end of the proximal and distal exposed
band members 14. A portion of the exposedmembers 14 that is attached to thegraft material members 14 that is exposed and extends away from thegraft material members 14 in any detail. - Yet a further example of a prior art exposed stent can be found in U.S. Pat. No. 5,824,036 to Lauterjung, which, of all of the prior art embodiments described herein, shows the most pointed of exposed stents. Specifically, the proximal ends of the exposed stent are apices pointed like a minaret. The minaret points are so shaped intentionally to allow forks 300 (see Lauterjung at
FIG. 5 ) external to the stent 154 to pull the stent 154 from the sheath 302, as opposed to being pushed. - A final example of a prior art exposed stent can be found in U.S. Pat. No. 5,755,778 to Kleshinski. The Kleshinski exposed stents each have two different shaped portions, a triangular base portion and a looped end portion. The totality of each exposed cycle resembles a castellation. Even though the end-most portion of the stent is curved, because it is relatively narrow, it still creates the possibility of piercing the vessel wall.
- All of these prior art stents suffer from the disadvantageous characteristic that the relatively sharp proximal apices of the exposed stents have a shape that is likely to puncture the vessel wall.
- Devices other than exposed stents have been used to inhibit graft migration. A second of such devices is the placement of a relatively stiff longitudinal support member longitudinally extending along the entirety of the graft.
- The typical stent graft has a tubular body and a circumferential framework. This framework is not usually continuous. Rather, it typically takes the form of a series of rings along the tubular graft. Some stent grafts have only one or two of such rings at the proximal and/or distal ends and some have many stents tandemly placed along the entirety of the graft material. Thus, the overall stent graft has an “accordion” shape. During the systolic phase of each cardiac cycle, the hemodynamic pressure within the vessel is substantially parallel with the longitudinal plane of the stent graft. Therefore, a device having unsecured sterns, could behave like an accordion or concertina with each systolic pulsation, and may have a tendency to migrate downstream. (A downstream migration, to achieve forward motion, has a repetitive longitudinal compression and extension of its cylindrical body.) Such movement is entirely undesirable. Connecting the stents with support along the longitudinal extent of the device thereof can prevent such movement. To provide such support, a second anti-migration device can be embodied as a relatively stiff longitudinal bar connected to the framework.
- A clear example of a longitudinal support bar can be found in Pinheiro I (U.S. Pat. No. 6,355,056) and Pinheiro II (U.S. Pat. No. 5,851,228). Each of these references discloses a plurality of longitudinally extending
struts 40 extending between and directly interconnecting the proximal and distal exposed stents 20 a, 20 b. These struts 40 are designed to extend generally parallel with the inner lumen 15 of thegraft 10, in other words, they are straight. - Another example of a longitudinal support bar can be found in U.S. Pat. No. 6,464,719 to Jayaraman. The Jayaraman stent is formed from a graft tube 21 and a supporting sheet 1 made of nitinol. This sheet is best shown in
FIG. 3 . Theend pieces FIGS. 1 and 4 . Alternatively, a plurality of connecting pieces 53 with holes at each end thereof can be attached to a cylindrical fabric tube 51 by stitching or sutures 57, as shown inFIG. 8 . Jayaraman requires more than one of these serpentine shaped connecting pieces 53 to provide longitudinal support. - United States Patent Publication 2002/0016627 and U.S. Pat. No. 6,312,458 to Golds each disclose a variation of a coiled securing
member 20. - A different kind of supporting member is disclosed in FIG. 8 of U.S. Pat. No. 6,053,943 to Edwin et al.
- Like Jayaraman, U.S. Pat. No. 5,871,536 to Lazarus discloses a plurality of straight, longitudinal support structures 38 attached to the circumferential support structures 36, see
FIGS. 1 , 6, 7, 8, 10, 11, 12, 14.FIG. 8 of Lazarus illustrates the longitudinal support structures 38 attached to a distal structure 36 and extending almost all of the way to the proximal structure 36. The longitudinal structures 38, 84, 94 can, be directly connected to thebody 22, 80 and can be telescopic 38, 64. - United States Patent Publication 2003/0088305 to Van Schie et al. (hereinafter “Van Schie”) does not disclose a support bar. Rather, it discloses a curved stent graft using an elastic material 8 connected to stents at a proximal end 2 and at a distal end 3 (see
FIGS. 1 , 2) thereof to create a curved stent graft. Because Van Schie needs to create a flexible curved graft, the elastic material 8 is made of silicone rubber or another similar material. Thus, the material 8 cannot provide support in the longitudinal extent of the stent graft. Accordingly, an alternative to the elastic support material 8 is asuture material 25 shown inFIGS. 3 to 6 . - The invention provides a method of forming a non-circular stent that overcomes the hereinafore-mentioned disadvantages of the heretofore-known devices and methods of this general type and that provides a vessel repair device that implants/conforms more efficiently within the natural or diseased course of the aorta by aligning with the natural curve of the aorta, decreases the likelihood of vessel puncture, increases the blood-tight vascular connection, retains the intraluminal wall of the vessel position, is more resistant to migration, and delivers the stent graft into a curved vessel while minimizing intraluminal forces imparted during delivery and while minimizing the forces needed for a user to deliver the stent graft into a curved vessel.
- With the foregoing and other objects in view, there is provided, in accordance with the invention, method for manufacturing a stent, including the steps of providing a mandrel with an outer surface having a polygonal cross-sectional shape and a longitudinal axis, winding stent wire around the outer surface of the mandrel about the longitudinal axis into a desired final shape, the desired final shape being polygonal in an elevation orthogonal to the longitudinal axis, and forming a stent by setting the wound stent wire in the desired polygonal final shape.
- With the objects of the invention in view, there is also provided a method for manufacturing a stent, including the steps of providing a mandrel with a multiple-sided outer surface and a longitudinal axis, winding a stent wire around the outer surface of the mandrel into a desired final shape substantially corresponding to a shape of the outer surface, and forming a stent by setting the wound stent wire into the desired final shape.
- In accordance with another mode of the invention, the mandrel is provided with flat sections and rounded edge portions between the flat sections.
- With the objects of the invention in view, the stent forming step is carried out by setting the stent wire to have rounded edges corresponding to the rounded edge portions of the mandrel and with flat sides corresponding to the flat sections of the mandrel.
- With the objects of the invention in view, pins are placed on the outer surface of the mandrel longitudinally offset from one another and corresponding to desired Z-stent apex locations and Z-stent apices are formed by winding the stent wire around the pins.
- In accordance with a further mode of the invention, the pin placing step is carried out by placing the pins on the mandrel to protrude perpendicularly from the outside surface of the mandrel.
- In accordance with an added mode of the invention, pins are placed on at least some of the rounded edge portions of the mandrel longitudinally offset from one another and corresponding to desired Z-stent apex locations and Z-stent apices are formed by winding the stent wire around the pins.
- In accordance with an additional mode of the invention, the pins are placed at each of the rounded edge portions of the mandrel and the setting step is carried out to form the stent with substantially linear struts lying flat against the flat sections of the mandrel.
- In accordance with yet another mode of the invention, the mandrel is provided in a dodecahedron shape and the setting step is carried out on the mandrel to form a Z-stent having six proximal and six distal apices.
- In accordance with yet a further mode of the invention, two ends of the stent wire are fastened to one another to complete the stent.
- In accordance with yet an added mode of the invention, the stent wire is initially provided as a cold-drawn shape-memory wire and the setting step is carried out by heat-treatment. In one embodiment, the heat-treatment step is carried out by exposing the shape-memory wire to a heat-setting temperature for a period of time with subsequent quenching as required to shape set the shape-memory wire to the then-existing shape of the wire on the mandrel and obtain superelastic mechanical characteristics of the shape-memory wire.
- In accordance with yet an additional mode of the invention, the setting step by exposing the wire to a process that shapes the wire to the then-existing shape of the wire on the mandrel selected from at least one of the group consisting of a mechanical process, a thermal process, and a chemical process.
- In accordance with still a further mode of the invention, the outer surface of the mandrel is provided with a polygonal cross-sectional shape.
- In accordance with still an added mode of the invention, the desired final shape is polygonal in an elevation orthogonal to the longitudinal axis.
- In accordance with a concomitant mode of the invention, the mandrel is provided with flat sections and rounded edge portions between the flat sections; and the stent forming step is carried out by setting the stent wire to have rounded edges corresponding to the rounded edge portions of the mandrel and with flat sides corresponding to the flat sections of the mandrel.
- Other features that are considered as characteristic for the invention are set forth in the appended claims.
- Although the invention is illustrated and described herein as embodied in a method of forming a non-circular stent, it is, nevertheless, not intended to be limited to the details shown because various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims.
- The construction and method of operation of the invention, however, together with additional objects and advantages thereof, will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings.
- The features of the present invention, which are believed to be novel, are set forth with particularity in the appended claims. The invention, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify like elements, and in which:
-
FIG. 1 is a side elevational view of a stent graft according to the invention; -
FIG. 2 is a side elevational view of a stent of the stent graft ofFIG. 1 ; -
FIG. 3 is a cross-sectional view of the stent ofFIG. 2 with different embodiments of protrusions; -
FIG. 4 is a perspective view of a prior art round mandrel for forming prior art stents; -
FIG. 5 is a fragmentary, side elevational view of a prior art stent in a portion of a vessel; -
FIG. 6 is a perspective view of a dodecahedral-shaped mandrel for forming stents inFIGS. 1 to 3 ; -
FIG. 7 is a fragmentary, side elevational view of the stent ofFIGS. 1 to 3 in a portion of a vessel; -
FIG. 8 is a fragmentary, enlarged side elevational view of the proximal end of the stent graft ofFIG. 1 illustrating movement of a gimbaled end; -
FIG. 9 is a side elevational view of a two-part stent graft according to the invention; -
FIG. 10 is a fragmentary, side elevational view of a delivery system according to the invention with a locking ring in a neutral position; -
FIG. 11 is a fragmentary, side elevational view of the delivery system ofFIG. 10 with the locking ring in an advancement position and, as indicated by dashed lines, a distal handle and sheath assembly in an advanced position; -
FIG. 12 is a fragmentary, enlarged view of a sheath assembly of the delivery system ofFIG. 10 ; -
FIG. 13 is a fragmentary, enlarged view of an apex capture device of the delivery system ofFIG. 10 in a captured position; -
FIG. 14 is a fragmentary, enlarged view of the apex capture device ofFIG. 13 in a released position; -
FIG. 15 is a fragmentary, enlarged view of an apex release assembly of the delivery system ofFIG. 10 in the captured position; -
FIG. 16 is a fragmentary, enlarged view of the apex release assembly ofFIG. 15 in the captured position with an intermediate part removed; -
FIG. 17 is a fragmentary, enlarged view of the apex release assembly ofFIG. 16 in the released position; -
FIG. 18 is a fragmentary, side elevational view of the delivery system ofFIG. 11 showing how a user deploys the prosthesis; -
FIG. 19 is a fragmentary cross-sectional view of human arteries including the aorta with the assembly of the present invention in a first step of a method for inserting the prosthesis according to the invention; -
FIG. 20 is a fragmentary cross-sectional view of the arteries ofFIG. 19 with the assembly in a subsequent step of the method for inserting the prosthesis; -
FIG. 21 is a fragmentary cross-sectional view of the arteries ofFIG. 20 with the assembly in a subsequent step of the method for inserting the prosthesis; -
FIG. 22 is a fragmentary cross-sectional view of the arteries ofFIG. 21 with the assembly in a subsequent step of the method for inserting the prosthesis; -
FIG. 23 is a fragmentary cross-sectional view of the arteries ofFIG. 22 with the assembly in a subsequent step of the method for inserting the prosthesis; -
FIG. 24 is a fragmentary cross-sectional view of the arteries ofFIG. 23 with the assembly in a subsequent step of the method for inserting the prosthesis; -
FIG. 25 is a fragmentary, diagrammatic, perspective view of the coaxial relationship of delivery system lumen according to the invention; -
FIG. 26 is a fragmentary, cross-sectional view of the apex release assembly according to the invention; -
FIG. 27 is a fragmentary, side elevational view of the stent graft ofFIG. 1 with various orientations of radiopaque markers according to the invention; -
FIG. 28 is a fragmentary perspective view of the stent graft ofFIG. 1 with various orientations of radiopaque markers according to the invention; -
FIG. 29 is a perspective view of a distal apex head of the apex capture device ofFIG. 13 ; -
FIG. 30 is a fragmentary side elevational view of the distal apex head ofFIG. 29 and a proximal apex body of the apex capture device ofFIG. 13 with portions of a bare stent in the captured position; -
FIG. 31 is a fragmentary, side elevational view of the distal apex head and proximal apex body ofFIG. 30 with a portion of the proximal apex body cut away to illustrate the bare stent in the captured position; -
FIG. 32 is a fragmentary side elevational view of the distal apex head and proximal apex body ofFIG. 30 in the released position; -
FIG. 33 is a fragmentary, cross-sectional view of an embodiment of handle assemblies according to the invention; -
FIG. 34 is a cross sectional view of pusher clasp rotator of the handle assembly ofFIG. 33 ; -
FIG. 35 is a plan view of the pusher clasp rotator ofFIG. 34 viewed along line C-C; -
FIG. 36 is a plan and partially hidden view of the pusher clasp rotator ofFIG. 34 with a helix groove for a first embodiment of the handle assembly ofFIGS. 10 , 11, and 18; -
FIG. 37 is a cross-sectional view of the pusher clasp rotator ofFIG. 36 along section line A-A; -
FIG. 38 is a plan and partially hidden view of the pusher clasp rotator ofFIG. 36 ; -
FIG. 39 is a cross-sectional view of the pusher clasp rotator ofFIG. 38 along section line B-B; -
FIG. 40 is a perspective view of a rotator body of the handle assembly ofFIG. 33 ; -
FIG. 41 is an elevational and partially hidden side view of the rotator body ofFIG. 40 ; -
FIG. 42 is a cross-sectional view of the rotator body ofFIG. 41 along section line A-A; -
FIG. 43 is an elevational and partially hidden side view of the rotator body ofFIG. 40 ; -
FIG. 44 is an elevational and partially hidden side view of a pusher clasp body of the handle assembly ofFIG. 33 ; -
FIG. 45 is a cross-sectional view of the pusher clasp body ofFIG. 44 along section line A-A; -
FIG. 46 is a cross-sectional view of the pusher clasp body ofFIG. 44 along section line B-B; -
FIG. 47 is a fragmentary, side elevational view of a portion of the handle assembly ofFIG. 33 with a sheath assembly according to the invention; -
FIG. 48 is an exploded side elevational view of a portion of the handle assembly ofFIG. 47 ; -
FIG. 49 is a fragmentary elevational and partially hidden side view of a handle body of the handle assembly ofFIG. 33 ; -
FIG. 50 is a fragmentary, exploded side elevational view of a portion of a second embodiment of the handle assembly according to the invention; -
FIG. 51 is a fragmentary, side elevational view of the portion ofFIG. 50 in a neutral position; -
FIG. 52 is an exploded view of a first portion of the second embodiment of the handle assembly; -
FIG. 53 is a fragmentary, exploded view of a larger portion of the second embodiment of the handle assembly as compared toFIG. 52 with the first portion and the sheath assembly; -
FIG. 54 is perspective view of a clasp body of the second embodiment of the handle assembly; -
FIG. 55 is an elevational side view of the clasp body ofFIG. 54 ; -
FIG. 56 is a cross-sectional view of the clasp body ofFIG. 55 along section line A-A; -
FIG. 57 is a plan view of the clasp body ofFIG. 54 ; -
FIG. 58 is a plan view of the clasp body ofFIG. 57 viewed from section line B-B; -
FIG. 59 is a fragmentary and partially hidden side elevational view of a clasp sleeve of the second embodiment of the handle assembly; -
FIG. 60 is a fragmentary, cross-sectional view of a portion the clasp sleeve ofFIG. 59 along section line A; -
FIG. 61 is a fragmentary, cross-sectional view of the clasp sleeve ofFIG. 59 along section line C-C; -
FIG. 62 is a fragmentary and partially hidden side elevational view of the clasp sleeve ofFIG. 59 rotated with respect toFIG. 59 ; and -
FIG. 63 is a fragmentary, cross-sectional view of the nose cone and sheath assemblies ofFIG. 10 . - While the specification concludes with claims defining the features of the invention that are regarded as novel, it is believed that the invention will be better understood from a consideration of the following description in conjunction with the drawing figures, in which like reference numerals are carried forward.
- The present invention provides a stent graft and delivery system that treats, in particular, thoracic aortic defects from the brachiocephalic level of the aortic arch distally to a level just superior to the celiac axis and provides an endovascular foundation for an anastomosis with the thoracic aorta, while providing an alternative method for partial/total thoracic aortic repair by excluding the vessel defect and making surgical repair of the aorta unnecessary. The stent graft of the present invention, however, is not limited to use in the aorta. It can be endoluminally inserted in any accessible artery that could accommodate the stent graft's dimensions.
- Stent Graft
- The stent graft according to the present invention provides various features that, heretofore, have not been applied in the art and, thereby, provide a vessel repair device that implants/conforms more efficiently within the natural or diseased course of the aorta, decreases the likelihood of vessel puncture, and increases the blood-tight vascular connection, and decreases the probability of graft mobility.
- The stent graft is implanted endovascularly before or during or in place of an open repair of the vessel (i.e., an arch, in particular, the ascending and/or descending portion of the aorta) through a delivery system described in detail below. The typical defects treated by the stent graft are aortic aneurysms, aortic dissections, and other diseases such as penetrating aortic ulcer, coarctation, and patent ductus arteriosus, related to the aorta. When endovascularly placed in the aorta, the stent graft forms a seal in the vessel and automatically affixes itself to the vessel with resultant effacement of the pathological lesion.
- Referring now to the figures of the drawings in detail and first, particularly to
FIG. 1 thereof, there is shown an improved stent graft 1 having agraft sleeve 10 and a number ofstents 20. Thesestents 20 are, preferably, made of nitinol, an alloy having particularly special properties allowing it to rebound to a set configuration after compression, the rebounding property being based upon the temperature at which the alloy exists. For a detailed explanation of nitinol and its application with regard to stents, see, e.g., U.S. Pat. Nos. 4,665,906, 5,067,957, and 5,597,378 to Jervis and to Gianturco. - The
graft sleeve 10 is cylindrical in shape and is made of a woven graft material along its entire length. The graft material is, preferably, polyester, in particular, polyester referred to under the name DACRON® or other material types like Expanded Polytetrafluoroethylene (“EPTFE”), or other polymeric based coverings. Thetubular graft sleeve 10 has a framework of individual lumen-supporting wires each referred to in the art as astent 20. Connection of eachstent 20 is, preferably, performed by sewing a polymeric (nylon, polyester) thread around an entirety of thestent 20 and through thegraft sleeve 10. The stitch spacings are sufficiently close to prevent any edge of thestent 20 from extending substantially further from the outer circumference of thegraft sleeve 10 than the diameter of the wire itself. Preferably, the stitches have a 0.5 mm to 5 mm spacing. - The
stents 20 are sewn either to the exterior or interior surfaces of thegraft sleeve 10.FIG. 1 illustrates allstents exterior surface 16 of thegraft sleeve 10. In a preferred non-illustrated embodiment, the most proximal 23 and distal stents and abare stent 30 are connected to the interior surface of thegraft sleeve 10 and the remainder of thestents 20 are connected to theexterior surface 16. Another possible non-illustrated embodiment alternates connection of thestents graft sleeve 10 from the graft exterior surface to the graft interior surface, the alternation having any periodic sequence. - A
stent 20, when connected to thegraft sleeve 10, radially forces thegraft sleeve 10 open to a predetermined diameter D. The released radial force creates a seal with the vessel wall and affixes the graft to the vessel wall when the graft is implanted in the vessel and is allowed to expand. - Typically, the
stents 20 are sized to fully expand to the diameter D of the fully expandedgraft sleeve 10. However, a characteristic of the present invention is that each of thestents graft sleeve 10. Thus, when the stent graft 1 is fully expanded and resting on the internal surface of the vessel where it has been placed, eachstent 20 is imparting independently a radially directed force to thegraft sleeve 10. Such pre-compression, as it is referred to herein, is applied (1) to ensure that the graft covering is fully extended, (2) to ensure sufficient stent radial force to make sure sealing occurs, (3) to affix the stent graft and prevent it from kinking, and (4) to affix the stent graft and prevent migration. - Preferably, each of the
stents 20 is formed with a single nitinol wire. Of course other biocompatible materials can be used, for example, stainless steel, biopolymers, cobalt chrome, and titanium alloys. - The preferred shape of each
stent 20 corresponds to what is referred in the art as a Z-stent, see, e.g., Gianturco (although the shape of thestents 20 can be in any form that satisfies the functions of a self-expanding stent). Thus, the wire forming thestent 20 is a ring having a wavy or sinusoidal shape. In particular, an elevational view orthogonal to the center axis 21 of thestent 20 reveals a shape somewhere between a triangular wave and a sinusoidal wave as shown inFIG. 2 . In other words, the view ofFIG. 2 shows that thestents 20 each have alternating proximal 22 and distal 24 apices. Preferably, the apices have a radius r that does not present too great of a point towards a vessel wall to prevent any possibility of puncturing the vessel, regardless of the complete circumferential connection to thegraft sleeve 10. In particular, the radius r of curvature of the proximal 22 and distal 24 apices of thestent 20 are, preferably, equal. The radius of curvature r is between approximately 0.1 mm and approximately 3.0 mm, in particular, approximately 0.5 mm. - Another advantageous feature of a stent lies in extending the longitudinal profile along which the stent contacts the inner wall of a vessel. This longitudinal profile can be explained with reference to
FIGS. 3 to 7 . - Prior art stents and stents according to the present invention are formed on mandrels 29, 29′ by winding the wire around the mandrel 29, 29′ and forming the
apexes FIGS. 4 and 6 . Prior art stents are formed on a round mandrel 29 (also referred to as a bar). Astent 20′ formed on a round mandrel 29 has a profile that is rounded (seeFIG. 5 ). Because of the rounded profile, thestent 20′ does not conform evenly against the inner wall of the vessel 2 in which it is inserted. This disadvantage is critical in the area of stent graft 1 seal zones—areas where the ends of thegraft 10 need to be laid against the inner wall of the vessel 2. Clinical experience reveals thatstents 20′ formed with the round mandrel 29 do not lie against the vessel 2; instead, only a mid-section of thestent 20′ rests against the vessel 2, as shown inFIG. 5 . Accordingly, when such astent 20′ is present at either of the proximal 12 or distal 14 ends of the stent graft 1, the graft material flares away from the wall of the vessel 2 into the lumen—a condition that is to be avoided. An example of this flaring can be seen by comparing the upper and lower portions of the curved longitudinal profile of thestent 20′ inFIG. 5 with the linear longitudinal profile of the vessel 2. - To remedy this problem and ensure co-columnar apposition of the stent and vessel,
stents 20 of the present invention are formed on a multiple-sided mandrel. In particular, thestents 20 are formed on a polygonal-shaped mandrel 29′. The mandrel 29′ does not have sharp edges. Instead, it has flat sections and rounded edge portions between the respective flat sections. Thus, a stent formed on the mandrel 29′ will have a cross-section that is somewhat round but polygonal, as shown inFIG. 3 . The cross-sectional view orthogonal to the center axis 21 of such astent 20 will have beveled or rounded edges 31 (corresponding to the rounded edge portions of the mandrel 29′) disposed between flat sides or struts 33 (corresponding to the flat sections of the mandrel 29′). With stents manufactured in this way, the apices remain on the circumference of the graft and do not bend into the graft interior like prior art stents—an undesirable condition as explained in the preceding paragraph. Further, the struts of the stents so manufactured (the substantially linear portions of the stent between the apices) lie in the plane of the graft material when attached thereto as shown inFIG. 7 . In contrast, prior art struts are curved (seeFIG. 5 ) and, therefore, force the graft material inwards away from the vessel wall. As used herein, substantially linear means that the struts are sufficiently straight and level to substantially prevent displacement of an apex (which lies between two adjacent struts) towards the interior of the graft material to which the struts and apices are attached. - To manufacture the
stent 20, apexes of thestents 20 are formed by winding the wire over non-illustrated pins located on the rounded portions of the mandrel 29′. Thus, thestruts 33 lying between theapexes stents 20 lie flat against the flat sides of the mandrel 29′. When so formed on the inventive mandrel 29′, the longitudinal profile is substantially less rounded than the profile ofstent 20′ and, in practice, is substantially linear, - For
stents 20 having six proximal 22 and six distal 24 apices, thestents 20 are formed on a dodecahedron-shaped mandrel 29′ (a mandrel having twelve sides), which mandrel 29′ is shown inFIG. 6 . Astent 20 fowled on such a mandrel 29′ will have the cross-section illustrated inFIG. 3 . - The fourteen-
apex stent 20 shown inFIG. 7 illustrates astent 20 that has been formed on a fourteen-sided mandrel. Thestent 20 inFIG. 7 is polygonal in cross-section (having fourteen sides) and, as shown inFIG. 7 , has a substantially linear longitudinal profile. Clinically, the linear longitudinal profile improves the stent's 20 ability to conform to the vessel 2 and press thegraft sleeve 10 outward in the sealing zones at the extremities of theindividual stent 20. - Another way to improve the performance of the stent graft 1 is to provide the
distal-most stent 25 on the graft 10 (i.e., downstream) with additional apices and to give it a longer longitudinal length (i.e., greater amplitude) and/or a longer circumferential length. When astent 25 having a longer circumferential length is sewn to a graft, the stent graft 1 will perform better clinically. The improvement, in part, is due to a need for the distal portion of thegraft material 10 to be pressed firmly against the wall of the vessel. The additional apices result in additional points of contact between the stent graft 1 and vessel wall, thus ensuring better apposition to the wall of the vessel and better sealing of thegraft material 10 to the vessel. The increased apposition and sealing substantially improves the axial alignment of thedistal end 14 of the stent graft 1 to the vessel. As set forth above, each of thestents graft sleeve 10. Thus, if thedistal stent 25 also has a diameter larger than the diameter D, it will impart a greater radial bias on all 360 degrees of the corresponding section of the graft than stents not having such an oversized configuration. - A typical implanted stent graft 1 typically does not experience a lifting off at straight portions of a vessel because the radial bias of the stents acting upon the graft sleeve give adequate pressure to align the stent and graft sleeve with the vessel wall. However, when a typical stent graft is implanted in a curved vessel (such as the aorta), the distal end of the stent graft 1 does experience a lift off from the vessel wall. The increased apposition and sealing of the stent graft 1 according to the present invention substantially decreases the probability of lift off because the added height and additional apices enhance the alignment of the stent graft perpendicular to the vessel wall as compared to prior art stent grafts (no lift off occurs). The number of total apices of a stent is dependent upon the diameter of the vessel in which the stent graft 1 is to be implanted. Vessels having a smaller diameter have a smaller total number of apices than a stent to be implanted in a vessel having a larger diameter. Table 1 below indicates preferred stent embodiments for vessels having different diameters. For example, if a vessel has a 26 or 27 mm diameter, then a preferred diameter of the
graft sleeve 10 is 30 mm. For a 30 mm diameter graft sleeve, theintermediate stents 20 will have 5 apices on each side (proximal and distal) for a total of 10 apices. In other words, the stent defines 5 periodic “waves.” Thedistal-most stent 25, in comparison, defines 6 periodic “waves” and, therefore, has 12 total apices. It is noted that thedistal-most stent 25 inFIG. 1 does not have the additional apex. While Table 1 indicates preferred embodiments, these configurations can be adjusted or changed as needed. -
TABLE 1 Stent Apices/Side Vessel Diameter (mm) Graft Diameter (mm) (Distal-most Stent #) 19 22 5(5) 20-21 24 5(5) 22-23 26 5(5) 24-25 28 5(6) 26-27 30 5(6) 28-29 32 6(7) 30-31 34 6(7) 32-33 36 6(7) 34 38 6(7) 35-36 40 7(8) 37-38 42 7(8) 39-40 44 7(8) 41-42 46 7(8) - To increase the security of the stent graft 1 in a vessel, an exposed or
bare stent 30 is provided on the stent graft 1, preferably, only at theproximal end 12 of thegraft sleeve 10—proximal meaning that it is attached to the portion of thegraft sleeve 10 from which the blood flows into the sleeve, i.e., blood flows from thebare stent 30 and through thesleeve 10 to the left ofFIG. 1 . Thebare stent 30 is not limited to being attached at theproximal end 12. Another non-illustrated bare stent can be attached similarly to thedistal end 14 of thegraft sleeve 10. - Specifically, the
bare stent 30 is fixed to thegraft sleeve 10 only at thedistal apices 34 of thebare stent 30. Thus, thebare stent 30 is partially free to extend theproximal apices 32 away from the proximal end of thegraft sleeve 10. - The
bare stent 30 has various properties, the primary one being to improve the apposition of the graft material to the contour of the vessel wall and to align the proximal portion of the graft covering in the lumen of the arch and provide a blood-tight closure of theproximal end 12 of thegraft sleeve 10 so that blood does not pass between the vascular inside wall andouter surface 16 of the sleeve 10 (endoleak). - The preferred configuration for the radius of curvature a of the
distal apices 34 is substantially equal to the radius r of the proximal 22 and distal 24 apices of thestent 20, in particular, it is equal at least to the radius of curvature r of the proximal apices of thestent 20 directly adjacent thebare stent 30. Thus, as shown inFIG. 8 , a distance between theproximal apices 22 of the mostproximal stent 23 and crossing points of the exposed portions of thebare stent 30 are substantially at a same distance from one another all the way around the circumference of theproximal end 12 of thegraft sleeve 10. Preferably, this distance varies based upon the graft diameter. Accordingly, the sinusoidal portion of thedistal apices 34 connected to thegraft sleeve 10 traverse substantially the same path as that of thestent 23 closest to thebare stent 30. Thus, the distance d between thestent 22 and all portions of thebare stent 30 connected to thegraft sleeve 10 remain constant. Such a configuration is advantageous because it maintains the symmetry of radial force of the device about the circumference of the vessel and also aids in the synchronous, simultaneous expansion of the device, thus increasing apposition of the graft material to the vessel wall to induce a proximal seal—and substantially improve the proximal seal—due to increasing outward force members in contact with the vessel wall. - Inter-positioning the
stents apices 34 of thebare stent 30 are positioned within the troughs of thestent 23. A further advantage of such a configuration is that the overlap provides twice as many points of contact between the proximal opening of thegraft 10 and the vessel in which the stent graft 1 is implanted. The additional apposition points keep the proximal opening of thegraft sleeve 10 open against the vessel wall, which substantially reduces the potential for endoleaks. In addition, the overlap of thestents - In contrast to the
distal apices 34 of thebare stent 30, the radius of curvature β of the proximal apices 32 (those apices that are not sewn into the graft sleeve 10) is significantly larger than the radius of curvature α of thedistal apices 34. A preferred configuration for the bare stent apices has a radius approximately equal, to 1.5 mm for theproximal apices 32 and approximately equal to 0.5 mm for thedistal apices 34. Such a configuration, substantially prevents perforation of the blood vessel by theproximal apices 32, or, at a minimum, makes is much less likely for thebare stent 30 to perforate the vessel because of the less-sharp curvature of theproximal apices 32. - The
bare stent 30 also has an amplitude greater than theother stents 20. Preferably, the peak-to-peak amplitude of thestents 20 is approximately 1.3 cm to 1.5 cm, whereas the peak-to-peak amplitude of thebare stent 30 is approximately 2.5 cm to 4.0 cm. Accordingly, the force exerted by thebare stent 30 on the inner wall of the aorta (due to thebare stent 30 expanding to its native position) is spread over a larger surface area. Thus, thebare stent 30 of the present invention presents a less traumatic radial stress to the interior of the vessel wall—a characteristic that, while less per square rum than an individual one of thestents 20 would be, is sufficient, nonetheless, to retain theproximal end 12 in position. Simultaneously, the taller configuration of thebare stent 30 guides the proximal opening of the stent graft in a more “squared-off” manner. Thus, the proximal opening of the stent graft is more aligned with the natural curvature of the vessel in the area of the proximal opening. - As set forth above, because the vessel moves constantly, and due to the constantly changing pressure imparted by blood flow, any stent graft placed in the vessel has the natural tendency to migrate downstream. This is especially true when the stent graft 1 has
graft sleeve segments 18 with lengths defined by the separation of the stents on either end of thesegment 18, giving the stent graft 1 an accordion, concertina, or caterpillar-like shape. When such a shape is pulsating with the vessel and while hemodynamic pressure is imparted in a pulsating manner along the stent graft from theproximal end 12 to the downstreamdistal end 14, the stent graft 1 has a tendency to migrate downstream in the vessel. It is desired to have such motion be entirely prohibited. - Support along a longitudinal extent of the
graft sleeve 10 assists in preventing such movement. Accordingly, as set forth above, prior art stent grafts have provided longitudinal rods extending in a straight line from one stent to another. - The present invention, however, provides a longitudinal, spiraling/
helical support member 40 that, while extending relatively parallel to thelongitudinal axis 11 of thegraft sleeve 10, is not aligned substantially parallel to a longitudinal extent of the entirety of the stent graft 1 as done in the prior art, “Relatively parallel” is referred to herein as an extent that is more along thelongitudinal axis 11 of the stent graft 1 than along an axis perpendicular thereto. - Specifically, the
longitudinal support member 40 has a somewhat S-turn shape, in that, aproximal portion 42 is relatively parallel to theaxis 11 of thegraft sleeve 10 at a first degree 41 (being defined as a degree of the 360 degrees of the circumference of the graft sleeve 10), and adistal portion 44 is, also, relatively parallel to theaxis 11 of the tube graft, but at a differentsecond degree 43 on the circumference of thegraft sleeve 10. The difference between the first andsecond degrees graft sleeve 10. For an approximately 20 cm (approx. 8″) graft sleeve, for example, thesecond degree 43 is between 80 and 110 degrees away from thefirst degree 41, in particular, approximately 90 degrees away. In comparison, for an approximately 9 cm (approx. 3.5″) graft sleeve, thesecond degree 43 is between 30 and 60 degrees away from thefirst degree 41, in particular, approximately 45 degrees away. As set forth below, the distance between the first andsecond degrees - The
longitudinal support member 40 has a curvedintermediate portion 46 between the proximal anddistal portions longitudinal support member 40 is a single, one-piece rod made of stainless steel, cobalt chrome, nitinol, or polymeric material that is shaped as a fullycurved helix distal portions axis 11 of the stent graft 1 and thecentral portion 46 can be helically curved. - One way to describe the preferred curvature embodiment of the
longitudinal support member 40 can be using an analogy of asymptotes. If there are two asymptotes extending parallel to thelongitudinal axis 11 of thegraft sleeve 10 at the first andsecond degrees graft sleeve 10, then theproximal portion 42 can be on thefirst degree 41 or extend approximately asymptotically to thefirst degree 41 and thedistal portion 44 can be on thesecond degree 43 or extend approximately asymptotically to thesecond degree 43. Because thelongitudinal support member 40 is one piece in a preferred embodiment, thecurved portion 46 follows the natural curve formed by placing the proximal anddistal portions - In such a position, the curved
longitudinal support member 40 has a centerline 45 (parallel to thelongitudinal axis 11 of thegraft sleeve 10 halfway between the first andsecond degrees centerline 45 at approximately 20 to 40 degrees in magnitude, preferably at approximately 30 to 35 degrees. - Another way to describe the curvature of the longitudinal support member can be with respect to the
centerline 45. The portion of thelongitudinal support member 40 between thefirst degree 41 and thecenterline 45 is approximately a mirror image of the portion of thelongitudinal support member 40 between thesecond degree 43 and thecenterline 45, but rotated 180 degrees around an axis orthogonal to thecenterline 45. Such symmetry can be referred to herein as “reverse-mirror symmetrical.” - The
longitudinal support member 40 is, preferably, sewn to thegraft sleeve 10 in the same way as thestents 20. However, thelongitudinal support member 40 is not sewn directly to any of thestents 20 in the proximal portions of the graft. In other words, thelongitudinal support member 40 is independent of the proximal skeleton formed by thestents 20. Such a configuration is advantageous because an independent proximal end creates a gimbal that endows the stent graft with additional flexibility. Specifically, the gimbaled proximal end allows the proximal end to align better to the proximal point of apposition, thus reducing the chance for endoleak. The additional independence from the longitudinal support member allows the proximal fixation point to be independent from the distal section that is undergoing related motion due to the physiological motion of pulsutile flow of blood. Also in a preferred embodiment, thelongitudinal support member 40 is pre-formed in the desired spiral/helical shape (counter-clockwise from proximal to distal), before being attached to thegraft sleeve 10. - Because vessels receiving the stent graft 1 are not typically straight, the final implanted position of the stent graft 1 will, most likely, be curved in some way. In prior art stent grafts (which only provide longitudinally parallel support rods), there exist, inherently, a force that urges the rod, and, thereby, the entire stent graft, to the straightened, natural shape of the rod. This force is disadvantageous for stent grafts that are to be installed in an at least partly curved manner.
- The curved shape of the
longitudinal support member 40 according to the present invention eliminates at least a majority, or substantially all, of this disadvantage because the longitudinal support member's 40 natural shape is curved and, therefore, imparts less of a force, or none at all, to straighten thelongitudinal support member 40, and, thereby, move the implanted stent graft in an undesirable way. At the same time, the curvedlongitudinal support member 40 negates the effect of the latent kinetic force residing in the aortic wall that is generated by the propagation of the pulse wave and systolic blood pressure in the cardiac cycle, which is, then, released during diastole. - In a preferred embodiment, the
longitudinal support member 40 can be curved in a patient-customized way to accommodate the anticipated curve of the actual vessel in which the graft will be implanted. Thus, the distance between the first andsecond degrees longitudinal support member 40 will, actually, exhibit an opposite force against any environment that would alter its conformance to the shape of its resident vessel's existing course(es). - Preferably, the
support member 40 is sewn, in a similar manner as thestents 20, on theoutside surface 16 of thegraft sleeve 10. - In prior art support rods, the ends thereof are merely a terminating end of a steel or nitinol rod and are, therefore, sharp. Even though these ends are sewn to the tube graft in the prior art, the possibility of tearing the vessel wall still exists. It is, therefore, desirable to not provide the support rod with sharp ends that could puncture the vessel in which the stent graft is placed.
- The two ends of the longitudinal,
support member 40 of the present invention do not end abruptly. Instead, each end of the longitudinalsupport member loops 47 back upon itself such that the end of the longitudinal support member along the axis of the stent graft is not sharp and, instead, presents an exterior of a circular or oval shape when viewed from theends graft sleeve 10. Such a configuration substantially prevents the possibility of tearing the vessel wall and also provides additional longitudinal support at the oval shape by having two longitudinally extending sides of the oval 47. - In addition, in another embodiment, the end of the longitudinal support member may be connected to the second
proximal stent 28 and to the most distal stent. This configuration would allow the longitudinal support member to be affixed to stent 28 (seeFIG. 1 ) and the most distal stent for support while still allowing for the gimbaled feature of the proximal end of the stent graft to be maintained. - A significant feature of the
longitudinal support member 40 is that the ends of thelongitudinal support member 40 may not extend all the way to the two ends 12, 14 of thegraft sleeve 10. Instead, thelongitudinal support member 40 terminates at or prior to the second-to-last stent 28 at theproximal end 12, and, if desired, prior to the second-to-last stent 28′ at thedistal end 14 of thegraft sleeve 10. Such an ending configuration (whether proximal only or both proximal and distal) is chosen for a particular reason—when thelongitudinal support member 40 ends before either of the planes defined bycross-sectional lines sleeve 10 and thestents 20 connected thereto respectively formgimbaled portions graft sleeve 10 about thelongitudinal axis 11 starting from the planes defined by thecross-sectional lines portions FIG. 8 . The natural gimbal, thus, allows the ends 50, 50′ to be inclined in any radial direction away from thelongitudinal axis 11. - Among other things, the gimbaled ends 50, 50′ allow each end opening to dynamically align naturally to the curve of the vessel in which it is implanted. A significant advantage of the gimbaled ends 50, 50′ is that they limit propagation of the forces acting upon the separate parts. Specifically, a force that, previously, would act upon the entirety of the stent graft 1, in other words, both the
end portions planes end portions planes respective end - Another advantage of the
longitudinal support member 40 is that it increases the columnar strength of the graft stent 1. Specifically, the material of the graft sleeve can be compressed easily along thelongitudinal axis 11, a property that remains true even with the presence of thestents 20 so long as thestents 20 are attached to thegraft sleeve 10 with a spacing between thedistal apices 24 of onestent 20 and theproximal apices 22 of the nextadjacent stout 20. This is especially true for the amount of force imparted by the flow of blood along the extent of thelongitudinal axis 11. However, with thelongitudinal support member 40 attached according to the present invention, longitudinal strength of the stent graft 1 increases to overcome the longitudinal forces imparted by blood flow. - Another benefit imparted by having such increased longitudinal strength is that the stent graft 1 is further prevented from migrating in the vessel because the tube graft is not compressing and expanding in an accordion-like manner—movement that would, inherently, cause graft migration.
- A further measure for preventing migration of the stent graft 1 is to equip at least one of any of the
individual stents longitudinal support member 40 withprotuberances 60, such as barbs or hooks (FIG. 3 ). See, e.g., United States Patent Publication 2002/0052660 to Greenhalgh. In the preferred embodiment of the present invention, thestents circumferential surface 16 of thegraft sleeve 10. Accordingly, if the stents 20 (or connected portions of stent 30) haveprotuberances 60 protruding outwardly, then such features would catch the interior wall of the vessel and add to the prevention of stout graft 1 migration. Such an embodiment can be preferred for aneurysms but is not preferred for the fragile characteristics of dissections becausesuch protuberances 60 can excoriate the inner layer(s) of the vessel and cause leaks between layers, for example. - As shown in
FIG. 9 , the stent graft 1 is not limited to asingle graft sleeve 10. Instead, the entire stent graft can be afirst stent graft 100 having all of the features of the stent graft 1 described above and asecond stent graft 200 that, instead of having a circular extremeproximal end 12, as set forth above, has aproximal end 212 with a shape following the contour of the mostproximal stent 220 and is slightly larger in circumference than the distal circumference of thefirst stent graft 100. Therefore, an insertion of theproximal end 212 of thesecond stent graft 200 into thedistal end 114 of thefirst stent graft 100 results, in total, in a two-part stent graft. Because blood flows from theproximal end 112 of thefirst stent graft 100 to thedistal end 214 of thesecond stent graft 200, it is preferable to have thefirst stent graft 100 fit inside thesecond stent graft 200 to prevent blood from leaking out therebetween. This configuration can be achieved by implanting the devices in reverse order (first implant graft 200 and, then,implant graft 100. Each of thestent grafts longitudinal support member 40 as needed. - It is not significant if the stent apices of the distal-most stent of the
first stent graft 100 are not aligned with the stent apices of theproximal-most stent 220 of thesecond stent graft 200. What is important is the amount of junctional overlap between the twografts - Delivery System
- As set forth above, the prior art includes many different systems for endoluminally delivering a prosthesis, in particular, a stent graft, to a vessel. Many of the delivery systems have similar parts and most are guided along a guidewire that is inserted, typically, through an insertion into the femoral artery near a patient's groin prior to use of the delivery system. To prevent puncture of the arteries leading to and including the aorta, the delivery system is coaxially connected to the guidewire and tracks the course of the guidewire up to the aorta. The parts of the delivery system that will track over the wire are, therefore, sized to have an outside diameter smaller than the inside diameter of the femoral artery of the patient. The delivery system components that track over the guidewire include the stent graft and are made of a series of coaxial lumens referred to as catheters and sheaths. The stent graft is constrained, typically, by an outer catheter, requiring the stent graft to be compressed to fit inside the outer catheter. Doing so makes the portion of the delivery system that constrains the stent graft very stiff, which, therefore, reduces that portion's flexibility and makes it difficult for the delivery system to track over the guidewire, especially along curved vessels such as the aortic arch. In addition, because the stent graft exerts very high radial forces on the constraining catheter due to the amount that it must be compressed to fit inside the catheter, the process of deploying the stent graft by sliding the constraining catheter off of the stent graft requires a very high amount of force, typically referred to as a deployment force. Also, the catheter has to be strong enough to constrain the graft, requiring it to be made of a rigid material. If the rigid material is bent, such as when tracking into the aortic arch, the rigid material tends to kink, making it difficult if not impossible to deploy the stent graft.
- Common features of vascular prosthesis delivery systems include a tapered nose cone fixedly connected to a guidewire lumen, which has an inner diameter substantially corresponding to an outer diameter of the guidewire such that the guidewire lumen slides easily over and along the guidewire. A removable, hollow catheter covers and holds a compressed prosthesis in its hollow and the catheter is fixedly connected to the guidewire lumen. Thus, when the prosthesis is in a correct position for implantation, the physician withdraws the hollow catheter to gradually expose the self-expanding prosthesis from its proximal end towards its distal end. When the catheter has withdrawn a sufficient distance from each portion of the expanding framework of the prosthesis, the framework can expand to its native position, preferably, a position that has a diameter at least as great as the inner diameter of the vessel wall to, thereby, tightly affix the prosthesis in the vessel. When the catheter is entirely withdrawn from the prosthesis and, thereby, allows the prosthesis to expand to the diameter of the vessel, the prosthesis is fully expanded and connected endoluminally to the vessel along the entire extent of the prosthesis, e.g., to treat a dissection. When treating an aneurysm, for example, the prosthesis is in contact with the vessel's proximal and distal landing zones when completely released from the catheter. At such a point in the delivery, the delivery system can be withdrawn from the patient. The prosthesis, however, cannot be reloaded in the catheter if implantation is not optimal.
- The aorta usually has a relatively straight portion in the abdominal region and in a lower part of the thoracic region. However, in the upper part of the thoracic region, the aorta is curved substantially, traversing an upside-down U-shape from the back of the heart over to the front of the heart. As explained above, prior art delivery systems are relatively hard and inflexible (the guidewire/catheter portion of the prior art delivery systems). Therefore, if the guidewire/catheter must traverse the curved portion of the aorta, it will kink as it is curved or it will press against the top portion of the aortic curve, possibly puncturing the aorta if the diseased portion is located where the guidewire/catheter is exerting its force. Such a situation must be avoided at all costs because the likelihood of patient mortality is high. The prior art does not provide any way for substantially reducing the stress on the curved portion of the aorta or for making the guidewire/catheter sufficiently flexible to traverse the curved portion without causing damage to the vessel.
- The present invention, however, provides significant features not found in the prior art that assist in placing a stent graft in a curved portion of the aorta in a way that substantially reduces the stress on the curved portion of the aorta and substantially reduces the insertion forces needed to have the compressed graft traverse the curved portion of the aorta. The delivery system of the present invention also has a very simple to use handle assembly. The handle assembly takes advantage of the fact that the inside diameter of the aorta is substantially larger that the inside diameter of the femoral arteries. The present invention, accordingly, uses a two-stage approach in which, after the device is inserted in through the femoral artery and tracks up into the abdominal area of the aorta (having a larger diameter (see
FIG. 19 ) than the femoral artery), a second stage is deployed (seeFIG. 20 ) allowing a small amount of expansion of the stent graft while still constrained in a sheath; but this sheath, made of fabric/woven polymer or similar flexible material, is very flexible. Such a configuration gives the delivery system greater flexibility for tracking, reduces deployment forces because of the larger sheath diameter, and easily overcome kinks because the sheath is made of fabric. - To describe the delivery system of the present invention, the method for operating the
delivery assembly 600 will be described first in association withFIGS. 10 , 11, and 12. Thereafter, the individual components will be described to allow a better understanding of how each step in the process is effected for delivering the stent graft 1 to any portion of the aorta 700 (seeFIGS. 19 to 24 ), in particular, thecurved portion 710 of the aorta. - Initially, the
distal end 14 of the stent graft 1 is compressed and placed into a hollow, cup-shaped, or tubular-shaped graft holding device, in particular, the distal sleeve 644 (see, e.g.,FIG. 25 ). At this point, it is noted that the convention for indicating direction with respect to delivery systems is opposite that of the convention for indicating direction with respect to stent grafts. Therefore, the proximal direction of the delivery system is that portion closest to the user/physician employing the system and the distal direction corresponds to the portion farthest away from the user/physician, i.e., towards thedistal-most nose cone 632. - The
distal sleeve 644 is fixedly connected to the distal end of thegraft push lumen 642, which lumen 642 provides an end face for thedistal end 14 of the stent graft 1. Alternatively, thedistal sleeve 644 can be removed entirely. In such a configuration, as shown inFIG. 12 , for example, the proximal taper of theinner sheath 652 can provide the measures for longitudinally holding the compressed distal end of the graft 1. As set forth in more detail below, each apex 32 of thebare stent 30 is, then, loaded into theapex capture device 634 so that the stent graft 1 is held at both its proximal and distal ends. The loadeddistal end 14, along with thedistal sleeve 644 and thegraft push lumen 642, are, in turn, loaded into theinner sheath 652, thus, further compressing the entirety of the stent graft 1. The capturedbare stent 30, along with the nose cone assembly 630 (including the apex capture device 634), is loaded until the proximal end of thenose cone 632 rests on the distal end of theinner sheath 652. The entirenose cone assembly 630 andsheath assembly 650 is, then, loaded proximally into the rigidouter catheter 660, further compressing the stent graft 1 (resting inside the inner sheath 652) to its fully compressed position for later insertion into a patient. SeeFIG. 63 . - The stent graft 1 is, therefore, held both at its proximal and distal ends and, thereby, is both pushed and pulled when moving from a first position (shown in
FIG. 19 and described below) to a second position (shown inFIG. 21 and described below). Specifically, pushing is accomplished by the non-illustrated interior end face of the hollow distal sleeve 644 (or thetaper 653 of the inner sheath 652) and pulling is accomplished by the hold that theapex capture device 634 has on theapices 32 of thebare stent 30. - The
assembly 600 according to the present invention tracks along aguidewire 610 already inserted in the patient and extending through the aorta and up to, but not into, the left ventricle of theheart 720. Therefore, aguidewire 610 is inserted through theguidewire lumen 620 starting from thenose cone assembly 630, through thesheath assembly 650, through thehandle assembly 670, and through theapex release assembly 690. Theguidewire 610 extends out the proximal-most end of theassembly 600. Theguidewire lumen 620 is coaxial with thenose cone assembly 630, thesheath assembly 650, thehandle assembly 670, and theapex release assembly 690 and is the innermost lumen of theassembly 600 immediately surrounding theguidewire 610. - Before using the
delivery system assembly 600, all air must be purged from inside theassembly 600. Therefore, a liquid, such as sterile U.S.P. saline, is injected through a non-illustrated tapered luer fitting to flush the guidewire lumen at a non-illustrated purge port located near a proximal end of the guidewire lumen. Second, saline is also injected through the luer fitting 612 of the lateral purge-port (seeFIG. 11 ), which liquid fills the entire internal co-axial space of thedelivery system assembly 600. It may be necessary to manipulate the system to facilitate movement of the air to be purged to the highest point of the system. - After purging all air, the system can be threaded onto the guidewire and inserted into the patient. Because the
outer catheter 660 has a predetermined length, the fixed front handle 672 can be disposed relatively close to the entry port of the femoral artery. It is noted, however, that the length of theouter catheter 660 is sized such that it will not have the fixedproximal handle 672 directly contact the entry port of the femoral artery in a patient who has the longest distance between the entry port and the thoracic/abdominal junction delivery assembly 600 of the present invention can be used with typical anatomy of the patient. Of course, theassembly 600 can be sized to any usable length. - The
nose cone assembly 630 is inserted into a patient's femoral artery and follows theguidewire 610 until thenose cone 632 reaches the first position at a level of the celiac axis. The first position is shown inFIG. 19 . Thenose cone assembly 630 is radiopaque, whether wholly or partially, to enable the physician to determine fluoroscopically, for example, that thenose cone assembly 630 is in the first position. For example, thenose cone 632 can have aradiopaque marker 631 anywhere thereon or thenose cone 632 can be entirely radiopaque. - After the
nose cone assembly 630 is in the first position shown inFIG. 19 , thelocking ring 676 is placed from its neutral position N, shown inFIG. 10 , into its advancement position A, shown inFIG. 11 . As will be described below, placing thelocking ring 676 into its advancement position A allows both thenose cone assembly 630 and theinternal sheath assembly 650 to move as one when theproximal handle 678 is moved in either the proximal or distal directions because thelocking ring 676 radially locks thegraft push lumen 642 to the lumens of the apex release assembly 690 (including theguidewire lumen 620 and an apex release lumen 640). Thelocking ring 676 is fixedly connected to asheath lumen 654. - Before describing how various embodiments of the
handle assembly 670 function, a summary of the multi-lumen connectivity relationships, throughout the neutral N, advancement A, and deployment D positions, is described. - When the locking ring is in the neutral position N shown in
FIG. 10 , thepusher clasp spring 298 shown inFIG. 48 and theproximal spring 606 shown inFIG. 52 are both disengaged. This allows free movement of thegraft push lumen 642 with theguidewire lumen 620 and theapex release lumen 640 within thehandle body 674. - When the
locking ring 676 is moved into the advancement position A, shown inFIG. 11 , thepusher clasp spring 298 shown inFIG. 48 is engaged and theproximal spring 606 shown inFIG. 52 is disengaged. The sheath lumen 654 (fixedly attached to the inner sheath 652) is, thereby, locked to the graft push lumen 642 (fixedly attached to the distal sleeve 644) so that, when theproximal handle 678 is moved toward thedistal handle 672, both thesheath lumen 654 and thegraft push lumen 642 move as one. At this point, thegraft push lumen 642 is also locked to both theguidewire lumen 620 and the apex release lumen 640 (which are locked to one another through theapex release assembly 690 as set forth in more detail below). Accordingly, as theproximal handle 678 is moved to the second position, shown with dashed lines inFIG. 11 , thesheath assembly 650 and thenose cone assembly 630 progress distally out of theouter catheter 660 as shown inFIGS. 20 and 21 and with dashed lines inFIG. 11 . - At this point, the
sheath lumen 654 needs to be withdrawn from the stent graft 1 to, thereby, expose the stent graft 1 from itsproximal end 12 to itsdistal end 14 and, ultimately, entirely off of itsdistal end 14. Therefore, movement of thelocking ring 676 into the deployment position D will engage theproximal spring 606 shown inFIG. 52 and disengage thepusher clasp spring 298 shown inFIG. 48 . At this point, thegraft push lumen 642 along with theguidewire lumen 620 and theapex release lumen 640 are locked to thehandle body 674 so as not to move with respect to thehandle body 674. Thesheath lumen 654 is unlocked from thegraft push lumen 642. Movement of thedistal handle 678 back to the third position (proximally), therefore, pulls thesheath lumen 654 proximally, thus, proximally withdrawing theinner sheath 652 from the stent graft 1. - At this point, only the
bare stent 30 of the stent graft 1 is held by thedelivery assembly 600. Therefore, final release of the stent graft 1 occurs by releasing thebare stent 30 from thenose cone assembly 630, which is accomplished using theapex release assembly 690 as set forth below. - In order to explain how the locking and releasing of the lumen occur as set forth above, reference is made to
FIGS. 33 to 62 . -
FIG. 33 is a cross-sectional view of theproximal handle 678 and thelocking ring 676. Apusher clasp rotator 292 is disposed between aclasp sleeve 614 and thegraft push lumen 642. A specific embodiment of thepusher clasp rotator 292 is illustrated inFIGS. 30 through 35 . Also disposed between theclasp rotator 292 and thegraft push lumen 642 is arotator body 294, which is directly adjacent thegraft push lumen 642. A specific embodiment of therotator body 294 is illustrated inFIGS. 40 through 43 . Disposed between therotator body 294 and thesheath lumen 654 is apusher clasp body 296, which is fixedly connected to therotator body 294 and to thelocking ring 676. A specific embodiment of thepusher clasp body 296 is illustrated inFIGS. 44 through 46 . Apusher clasp spring 298 operatively connects thepusher clasp rotator 292 to the rotator body 294 (and, thereby, the pusher clasp body 296). - An exploded view of these components is presented in
FIG. 48 , where an O-ring 293 is disposed between therotator body 294 and thepusher clasp body 296. As shown in the plan view ofFIG. 47 , acrimp ring 295 connects thesheath lumen 654 to thedistal projection 297 of thepusher clasp body 296. Ahollow handle body 674, on which theproximal handle 678 and thelocking ring 676 are slidably mounted, holds thepusher clasp rotator 292, therotator body 294, thepusher clasp body 296, and thepusher clasp spring 298 therein. This entire assembly is rotationally mounted to thedistal handle 672 for rotating the stent graft 1 into position (seeFIGS. 23 and 24 and the explanations thereof below). A specific embodiment of thehandle body 674 is illustrated inFIG. 49 . - A
setscrew 679 extends from theproximal handle 678 to contact a longitudinally helixed groove in the pusher clasp rotator 292 (shown inFIGS. 36 and 38 ). Thus, when moving theproximal handle 678 proximally or distally, thepusher clasp rotator 292 rotates clockwise or counter-clockwise. - An alternative embodiment of the
locking ring 676 is shown inFIG. 50 et seq., which is the preferred embodiment because, instead of applying a longitudinal movement to rotate thepusher clasp spring 298 through the cam/follower feature of theproximal handle 678 andpusher clasp rotator 292, arotating locking knob 582 is located at the proximal end of thehandle body 674. Theknob 582 has three positions that are clearly shown inFIG. 51 : a neutral position N, an advancement position A, and a deployment position D. The functions of these positions N, A, D correspond to the positions N, A, D of thelocking ring 676 and theproximal handle 678 as set forth above. - In the alternative embodiment, a
setscrew 584 is threaded into theclasp sleeve 614 through aslot 675 in thehandle body 674 and through aslot 583 in theknob 582 to engage the lockingknob 582. Because of the x-axis orientation of theslot 583 in theknob 582 and the y-axis orientation of theslot 675 in thehandle body 674, when theknob 582 is slid over the end of thehandle body 674 and thesetscrew 584 is screwed into theclasp sleeve 614, theknob 582 is connected fixedly to thehandle body 674. When the lockingknob 582 is, thereafter, rotated between the neutral N, advancement A, and deployment D positions, theclasp sleeve 614 rotates to actuate the spring lock (seeFIGS. 48 and 52 ). - A
setscrew 586, shown inFIG. 53 , engages agroove 605 in theproximal clasp assembly 604 to connect theproximal clasp assembly 604 to theclasp sleeve 614 but allows theclasp sleeve 614 to rotate around theclasp body 602. Theclasp sleeve 614 is shown inFIGS. 50 and 53 and, in particular, inFIGS. 59 to 62 . Theproximal clasp assembly 604 ofFIG. 53 is more clearly shown in the exploded view ofFIG. 52 . Theproximal clasp assembly 604 is made of the components including aproximal spring 606, a lockingwasher 608, a fastener 603 (in particular, a screw fitting into internal threads of the proximal clasp body 602), and aproximal clasp body 602. Theproximal clasp body 602 is shown, in particular, inFIGS. 54 through 58 . Theproximal clasp assembly 604 is connected fixedly to thehandle body 674, preferably, with ascrew 585 shown inFIG. 50 and hidden from view inFIG. 51 underknob 582. - The
handle body 674 has aposition pin 592 for engaging in position openings at the distal end of the lockingknob 582. Theposition pin 592 can be a setscrew that only engages thehandle body 674. When the lockingknob 582 is pulled slightly proximally, therefore, the knob can be rotated clockwise or counter-clockwise to place thepin 592 into the position openings corresponding to the advancement A, neutral N, and deployment D positions. - As shown in
FIG. 18 , to begin deployment of the stent graft 1, the user/physician grasps both thedistal handle 672 and theproximal handle 678 and slides theproximal handle 678 towards thedistal handle 672 in the direction indicated by arrow A. This movement, as shown inFIGS. 19 to 21 , causes the flexibleinner sheath 652, holding the compressed stent graft 1 therein, to emerge progressively from inside theouter catheter 660. Such a process allows the stent graft 1, while constrained by theinner sheath 652, to expand to a larger diameter as shown inFIG. 12 , this diameter being substantially larger than the inner diameter of theouter catheter 660 but smaller than the inner diameter of the vessel in which it is to be inserted. Preferably, theouter catheter 660 is made of a polymer (co-extrusions or teflons) and theinner sheath 652 is made of a material, such as a fabric/woven polymer or other similar material. Therefore, theinner sheath 652 is substantially more flexible than theouter catheter 660. - It is noted, at this point, that the
inner sheath 652 contains ataper 653 at its proximal end, distal to the sheath's 652 connection to the sheath lumen 654 (at which theinner sheath 652 has a similar diameter to thedistal sleeve 644 working in conjunction with thedistal sleeve 644 to capture thedistal end 14 of the stent graft 1. Thetaper 653 provides a transition that substantially prevents any kinking of theouter catheter 660 when the stent graft 1 is loaded into the delivery assembly 600 (as in the position illustrated inFIGS. 10 and 11 ) and, also, when theouter catheter 660 is navigating through the femoral and iliac vessels. One specific embodiment of thesheath lumen 654 has a length between approximately 35 and 37 inches, in particular, 36 inches, an outer diameter of between approximately 0.20 and 0.25 inches, in particular 0.238 inches, and an inner diameter between approximately, 0.18 and approximately 0.22 inches, in particular, 0.206 inches. - When the
proximal handle 678 is moved towards its distal position, shown by the dashed lines inFIG. 11 , thenose cone assembly 630 and thesheath assembly 650 move towards a second position where thesheath assembly 650 is entirely out of theouter catheter 660 as shown inFIGS. 20 and 21 . As can be seen most particularly inFIGS. 20 and 21 , as thenose cone assembly 630 and thesheath assembly 650 are emerging out of theouter catheter 660, they are traversing thecurved portion 710 of the descending aorta. The tracking is accomplished visually by viewing radiopaque markers on various portions of the delivery system and/or the stent graft 1 with fluoroscopic measures. Such markers will be described in further detail below. The delivery system can be made visible, for example, by thenose cone 630 being radiopaque or containing radiopaque materials. - It is noted that if the harder
outer catheter 660 was to have been moved through thecurved portion 710 of theaorta 700, there is a great risk of puncturing theaorta 700, and, particularly, adiseased portion 744 of the proximal descendingaorta 710 because theouter catheter 660 is not as flexible as theinner sheath 652. But, because theinner sheath 652 is so flexible, thenose cone assembly 630 and thesheath assembly 650 can be extended easily into thecurved portion 710 of theaorta 700 with much less force on the handle than previously needed with prior art systems while, at the same time, imparting harmless forces to the intraluminal surface of thecurved aorta 710 due to the flexibility of theinner sheath 652. - At the second position shown in
FIG. 21 , the user/physician, using fluoroscopic tracking of radiopaque markers (e.g., marker 631) on any portion of the nose cone or on the stent graft 1 and/orsheath assemblies proximal end 112 of the stent graft 1 is in the correct longitudinal position proximal to thediseased portion 744 of theaorta 700. Because the entire insertedassembly aorta 700 is still rotationally connected to the portion of thehandle assembly 670 except distal handle 672 (distal handle 672 is connected with theouter sheath 660 and rotates independently of the remainder of the handle assembly 670), the physician can rotate the entire insertedassembly FIG. 21 by arrow B) merely by rotating theproximal handle 678 in the desired direction. Such a feature is extremely advantageous because the non-rotation of theouter catheter 660 while theinner sheath 652 is rotating eliminates stress on the femoral and iliac arteries when the rotation of theinner sheath 652 is needed and performed. - Accordingly, the stent graft 1 can be pre-aligned to place the stent graft 1 in the correct circumferential position—defined by placing the
longitudinal support member 40 substantially at the superior longitudinal surface line of the curved aorta with respect to anatomical position).FIG. 23 illustrates thelongitudinal support member 40 not in the correct superior position andFIG. 24 illustrates thelongitudinal support member 40 in the correct superior position. The superior surface position is, preferably, the longest superior longitudinal line along the circumference of the curved portion of the aorta as shown inFIGS. 23 and 24 . As set forth above, when thelongitudinal support member 40 extends along the superior longitudinal line of the curved aorta, thelongitudinal support member 40 substantially eliminates any possibility of forming a kink in the inferior radial curve of the stent graft 1 during use and also allows transmission of longitudinal forces exerted along the inside lumen of the stent graft 1 to the entire longitudinal extent of the stent graft 1, thereby allowing the entire outer surface of the stent graft 1 to resist longitudinal migration. - In prior art stent grafts and stent graft delivery systems, the stent graft is, typically, provided with symmetrically-shaped radiopaque markers along one longitudinal line and at least one other symmetrically-shaped radiopaque marker disposed along another longitudinal line on the opposite side (180 degrees) of the stent graft. Thus, using two-dimensional fluoroscopic techniques, the only way to determine if the stent graft is in the correct rotational position is by having the user/physician rotate the stent graft in both directions until it is determined that the first longitudinal line is superior and the other longitudinal line is anterior. This required more work by the physician and is, therefore, undesirable.
- According to a preferred embodiment of the invention illustrated in
FIGS. 27 and 28 , uniqueradiopaque markers longitudinal support member 40 in the correct aortic superior surface position with only one directional rotation that is also the minimal rotation needed to place the stent graft 1 in the rotationally correct position. - Specifically, the stent graft 1 is provided with a pair of symmetrically shaped but diametrically
opposed markers longitudinal support member 40 to the superior longitudinal line of the curved aorta (with respect to anatomical position). Preferably, themarkers proximate end 12 of thegraft sleeve 10 on opposite sides (180 degrees) of thegraft sleeve 10. - The angular position of the
markers graft sleeve 10 is determined by the position of thelongitudinal support member 40. In a preferred embodiment, thesupport member 40 is between the twomarkers marker 232 is at a 0 degree position on thegraft sleeve 10 and themarker 234 is at a 180 degree position, then thecenterline 45 of thesupport member 40 is at a 90 degree position. However, an alternative position of the markers can place themarker 234 90 degrees away from the first degree 41 (seeFIG. 1 ). Such a positioning is dependent somewhat upon the way in which the implantation is to be viewed by the user/physician and can be varied based on other factors. Thus, the position can be rotated in any beneficial way. - Preferred ancillary equipment in endovascular placement of the stent graft 1 is a fluoroscope with a high-resolution image intensifier mounted on a freely angled C-arm. The C-arm can be portable, ceiling, or pedestal mounted. It is important that the C-arm have a complete range of motion to achieve AP to lateral projections without moving the patient or contaminating the sterile field. Capabilities of the C-arm should include: Digital Subtraction Angiography, High-resolution Angiography, and Roadmapping.
- For introduction of the delivery system into the groin access arteries, the patient is, first, placed in a sterile field in a supine position. To determine the exact target area for placement of the stent graft 1, the C-arm is rotated to project the patient image into a left anterior oblique projection, which opens the radial curve of the thoracic aortic arch for optimal visualization without superimposition of structures. The degree of patient rotation will vary, but is usually 40 to 50 degrees. At this point, the C-arm is placed over the patient with the central ray of the fluoroscopic beam exactly perpendicular to the target area. Such placement allows for the
markers - In a preferred embodiment, the
markers longitudinal support member 40.FIG. 27 , for example, illustrates a plan view of themarkers markers FIG. 28 . - Each of
FIGS. 27 and 28 have been provided with examples where themarkers FIG. 27 , twomarkers 232′, 234′ indicate a misaligned counter-clockwise-rotated stent graft 1 when viewed from theplane 236 at the right end of the stent graft 1 ofFIG. 23 looking toward the left end thereof and down theaxis 11. Thus, to align themarkers 232′, 234′ in the most efficient way possible (the shortest rotation), the user/physician sees that the distance between the two flat diameters is closer than the distance between the highest points of the hemispherical curves. Therefore, it is known that the two flat diameters must be joined together by rotating the stent graft 1 clockwise. -
FIG. 28 has also been provided with twomarkers 232″, 234″ indicating a misaligned clockwise-rotated stent graft 1 when viewed from theplane 236 at the right end of the stent graft 1 ofFIG. 27 looking toward the left end thereof and down theaxis 11. Thus, to align themarkers 232″, 234″ in the most efficient way possible (the shortest rotation), the user/physician sees that the distance between the highest points of the hemispherical curves is smaller than the distance between the two flat diameters. Therefore, it is known that the two flat diameters must be joined together by rotating the stent graft 1 in the direction that the highest points of the hemispherical curves point; in other words, the stent graft 1 must be rotated counter-clockwise. - A significant advantage provided by the diametrically opposed
symmetric markers - The hemispherical shape of the
markers markers markers - When the stent graft 1 is in place both longitudinally and circumferentially (
FIG. 21 ), the stent graft 1 is ready to be removed from theinner sheath 652 and implanted in thevessel 700. Because relative movement of the stent graft 1 with respect to the vessel is no longer desired, theinner sheath 652 needs to be retracted while the stent graft 1 remains in place, i.e., no longitudinal or circumferential movement. Such immovability of the stent graft 1 is insured by, first, theapex capture device 634 of thenose cone assembly 630 holding the front of the stent graft 1 by its bare stent 30 (seeFIGS. 13 , 22, and 23) and, second, by unlocking thelocking ring 676/placing the locking ring/knob in the D position—which allows thesheath lumen 654 to move independently from theguidewire lumen 620,apex release lumen 640, andgraft push lumen 642. Theapex capture device 634, as shown inFIGS. 13 , 14, 30 and 311 (and as will be described in more detail below), is holding each individualdistal apex 32 of thebare stent 30 in a secure manner—both rotationally and longitudinally. - The
nose cone assembly 630, along with theapex capture device 634, is securely attached to the guidewire lumen 620 (and theapex release lumen 640 at least until apex release occurs). Theinner sheath 652 is securely attached to asheath lumen 654, which is coaxially disposed around theguidewire lumen 620 and fixedly attached to theproximal handle 678. The stent graft 1 is also supported at its distal end by thegraft push lumen 642 and thedistal sleeve 644 or thetaper 653 of theinner sheath 652, (The entire coaxial relationship of thevarious lumen FIG. 25 , and a portion of which can also be seen in the exploded view of the handle assembly inFIG. 50 ) Therefore, when theproximal handle 678 is moved proximally with thelocking ring 676 in the deployment position D, thesheath lumen 654 moves proximally as shown inFIGS. 13 , 22, and 23, taking thesheath 652 proximally along with it while theguidewire lumen 620, theapex release lumen 640, thegraft push lumen 642, and thedistal sleeve 644 remain substantially motionless and, therefore, the stent graft 1 remains both rotationally and longitudinally steady. - The stent graft 1 is, now, ready to be finally affixed to the
aorta 700. To perform the implantation, thebare stent 30 must be released from theapex capture device 634. As will be described in more detail below, theapex capture device 634 shown inFIGS. 13 , 14, and 29 to 32, holds theproximal apices 32 of thebare stent 30 between thedistal apex head 636 and the proximalapex body 638. Thedistal apex head 636 is fixedly connected to theguidewire lumen 620. The proximalapex body 638, however, is fixedly connected to theapex release lumen 640, which is coaxial with both theguidewire lumen 620 and thesheath lumen 654 and disposed therebetween, as illustrated diagrammatically inFIG. 25 . (As will be described in more detail below, thegraft push lumen 642 is also fixedly connected to theapex release lumen 640.) Therefore, relative movement of theapex release lumen 640 and theguidewire lumen 620 separates thedistal apex head 636 and a proximalapex body 638 from one another. - To cause such relative movement, the
apex release assembly 690 has, in a preferred embodiment, three parts, adistal release part 692, aproximal release part 694, and an intermediate part 696 (which is shown in the form of a clip inFIGS. 16 and 26 ). To insure that thedistal apex head 636 and the proximalapex body 638 always remain fixed with respect to one another until thebare stent 30 is ready to be released, theproximal release part 694 is formed with adistal surface 695, thedistal release part 692 is formed with aproximal surface 693, and theintermediate part 696 has proximal and distal surfaces corresponding to thesurfaces intermediate part 696 is inserted removably between thedistal surface 695 and theproximal surface 693, theintermediate part 696 fastens thedistal release part 692 and theproximal release part 694 with respect to one another in a form-locking connection. A form-locking connection is one that connects two elements together due to the shape of the elements themselves, as opposed to a force-locking connection, which locks the elements together by force external to the elements. Specifically, as shown inFIG. 26 , theclip 696 surrounds adistal plunger 699 of theproximal release part 694 that is inserted slidably within a hollow 698 of thedistal release part 692. Theplunger 699 of theproximal release part 694 can slide within the hollow 698, but astop 697 inside the hollow 698 prevents thedistal plunger 699 from withdrawing from the hollow 698 more than the longitudinal span of theclip 696. - To allow relative movement between the
distal apex head 636 and the proximalapex body 638, theintermediate part 696 is removed easily with one hand and, as shown from the position inFIG. 16 to the position inFIG. 17 , thedistal release part 692 and theproximal release part 694 are moved axially towards one another (preferably, the former is moved towards the latter). Such movement separates thedistal apex head 636 and the proximalapex body 638 as shown inFIG. 14 . Accordingly, thedistal apices 32 of thebare stent 30 are free to expand to their natural position in which thebare stent 30 is released against thevessel 700. - Of course, the
apex release assembly 690 can be formed with any kind of connector that moves theapex release lumen 640 and theguidewire lumen 620 relative to one another. In a preferred alternative embodiment, for example, theintermediate part 696 can be a selectable lever that is fixedly connected to either one of thedistal release part 692 or theproximal release part 694 and has a length equal to the width of theclip 696 shown inFIG. 26 . Thus, when engaged by pivoting the lever between thedistal release part 692 and theproximal release part 694, for example, theparts parts distal release part 692 and theproximal release part 694 are free to move towards one another. - The apex clasp device is unique to the present invention in that it incorporates features that allow the longitudinal forces subjected on the stent graft 1 to be fully supported, through the
bare stent 30, by both theguidewire lumen 620 andapex release lumen 640. Support occurs by providing thedistal apex head 636 with adistal surface 639 supporting theproximal apices 32 of thebare stent 30, which is particularly shown in the enlarged perspective view of thedistal apex head 636 provided inFIG. 29 . Thedistal surface 639, in turn, rests on the proximalapex body 638 when in the closed position, as more clearly shown inFIGS. 30 and 31 . Thus, the longitudinal forces are fully transmitted to both theguidewire lumen 620 andapex release lumen 640, making the assembly much stronger. - Having the
distal surface 639 be the load-bearing surface of theproximal apices 32 ensures expansion of the each one of thedistal apices 32 from theapex release assembly 690. Theproximal surface 641 of thedistal apex head 636 meets with the interior surfaces of the proximalapex body 638 to help carry the apex load because the apices of thebare stent 30 are captured therebetween when theapex capture device 634 is closed. Such capture can be clearly seen in the cut-away view of the proximalapex body 638 inFIG. 31 . For release of theapices 32 of thebare stent 30, the proximalapex body 638 moves to the left (with respect toFIG. 32 ). Because of friction occurring between theapices 32 and the “teeth” of the proximalapex body 638 when theapices 32 are captured, theapices 32 will also try to move to the left along with the proximalapex body 638 and, if allowed to do so, possibly would never clear the “teeth” to allow each apex 32 to expand. However, as the proximalapex body 638 disengages (moves in the direction of arrow C inFIG. 31 ), direct contact with thedistal surface 639 entirely prevents theapices 32 from sliding in the direction of arrow C along with the proximalapex body 638 to ensure automatic release of every capturedapex 32 of thebare stent 30. Because the proximalapex body 638 continues to move to the left, eventually the “teeth” will clear their respective capture of theapices 32 and thebare stent 30 will, therefore, expand entirely. The release position of thedistal apex head 636 and the proximalapex body 638 is shown inFIG. 32 , and corresponds to the position of theapex release assembly 690 inFIG. 17 . As can be seen, tapers on the distal outer surfaces of the proximalapex body 638 further assist in the prevention of catching theproximal apices 32 of thebare stent 30 on any part of theapex capture device 634. - Simply put, the
apex capture device 634 provides support for load placed on the stent graft 1 during advancement A of theinner sheath 652 and during withdrawal of the inner sheath 652 (i.e., during deployment D). Such a configuration benefits the apposition of thebare stent 30 by releasing thebare stent 30 after theentire graft sleeve 10 has been deployed, thus reducing the potential for vessel perforation at the point of initial deployment. - When the stent graft 1 is entirely free from the
inner sheath 652 as shown inFIG. 23 , theproximal handle 678 is, then, substantially at or near the third position (deployment position) shown inFIG. 10 . - The stent graft 1 is, now, securely placed within the vessel and the
entire portion assembly 600 may be removed from the patient. - While the preferred embodiments of the invention have been illustrated and described, it will be clear that the invention is not so limited. Numerous modifications, changes, variations, substitutions, and equivalents will occur to those skilled in the art without departing from the spirit and scope of the present invention as defined by the appended claims.
Claims (26)
1.-22. (canceled)
23. An elastic compressible stent having a plurality of proximal and distal apices joined by struts that are essentially straight.
24. The stent of claim 23 , wherein the stent has a polygonal cross-sectional shape.
25. The stent of claim 24 , wherein the polygonal cross-sectional shape is a dodecahedron shape.
26. The stent of claim 23 , wherein the stent includes at least five, six, seven or eight proximal apices and at least five, six, seven or eight distal apices.
27. The stent of claim 1, wherein the stent will be in essentially co-columnar apposition with a blood vessel in which the stent is implanted.
28. The stent of claim 23 , wherein the stent has a multiple-sided outer surface.
29. The stent of claim 28 , wherein the stent will be in essentially co-columnar apposition with a blood vessel in which the stent is implanted.
30. The stent of claim 1, further including graft material, wherein the graft material is attached to the stent.
31. An elastic compressible stent having a plurality of proximal and distal apices joined by struts are essentially straight, made by a method, comprising the steps of:
a) winding stent wire around an outer surface of a longitudinal axis of a polygonal cross-sectional shaped mandrel into a desired final shape that is polygonal in an elevation orthogonal to the longitudinal axis; and
forming a stent by setting the wound stent wire in the desired polygonal final shape.
32. The stent of claim 31 , wherein the stent will be in essentially co-columnar apposition with a blood vessel in which the stent is implanted.
33. The stent of claim 31 , wherein the mandrel further includes flat sections and rounded edge portions between the flat sections.
34. The stent of claim 31 , wherein the method further includes the step of forming Z-stent apices by winding the stent wire around pins on the outer surface of the mandrel longitudinally offset from one another and corresponding to desired Z-stent apex locations.
35. The stent of claim 34 , wherein the stent is a Z-stent that includes at least five, six, seven or eight proximal apices and at least five, six, seven or eight distal apices.
36. The stent of claim 31 , wherein the mandrel has a dodecahedron shape.
37. The stent of claim 31 , wherein the method further includes the step of fastening two ends of the stent wire to one another to complete the stent.
38. The stent of claim 31 , wherein the stent wire is initially wound around the outer surface of the longitudinal axis of the mandrel as a cold-drawn shape-memory wire and formed by heat-treatment.
39. The stent of claim 38 , wherein the heat-treatment includes exposing the shape-memory wire to a heat-setting temperature for a period of time with subsequent quenching as required to shape set the shape-memory wire to the then-existing shape of the wire on the mandrel and obtain superelastic mechanical characteristics of the shape-memory wire.
40. The stent of claim 31 , wherein the stent wire is exposed to at least one of the group consisting of a mechanical process, a thermal process and a chemical process that shapes the wire to desired final shape on the mandrel.
41. An elastic compressible stent having a plurality of proximal and distal apices joined by struts that are essentially straight, made by a method comprising the steps of:
a) winding a stent wire around an outer surface of a longitudinal axis of a mandrel having a multiple-sided outer surface into a desired final shape substantially corresponding to a shape of the outer surface; and
b) forming a stent by setting the wound stent wire into the desired final shape.
42. The stent of claim 41 , wherein the mandrel includes flat sections and rounded edge portions between the flat sections and the stent is formed by setting the stent wire to have rounded edges corresponding to the rounded edge portions of the mandrel and with flat sides corresponding to the flat sections of the mandrel.
43. The stent of claim 41 , wherein the method further includes the steps of:
c) placing pins on the outer surface of the mandrel protruding perpendicularly therefrom and being longitudinally offset from one another to correspond with desired Z-stent apex locations; and
d) forming Z-stent apices of the stent by winding the stent wire around the pins.
44. The stent of claim 43 , wherein the pins are placed on each of the rounded edge portions of the mandrel.
45. The stent of claim 41 , wherein the method further includes the step of fastening two ends of the stent wire to one another to complete the stent.
46. The stent of claim 41 , wherein the stent wire is initially wound around the outer surface of the longitudinal axis of the mandrel as a cold-drawn shape-memory wire and the stent is formed by heat-treatment.
47. The stent of claim 41 , wherein the stent is formed by exposing the stent wire to at least one of the group consisting of a mechanical process, a thermal process, and a chemical process that shapes the wire to the desired final shape on the mandrel.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/040,755 US20110208288A1 (en) | 2003-09-03 | 2011-03-04 | Stents and stent grafts |
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US49965203P | 2003-09-03 | 2003-09-03 | |
US50015503P | 2003-09-04 | 2003-09-04 | |
US10/784,462 US8292943B2 (en) | 2003-09-03 | 2004-02-23 | Stent graft with longitudinal support member |
US11/699,701 US8007605B2 (en) | 2003-09-03 | 2007-01-30 | Method of forming a non-circular stent |
US13/040,755 US20110208288A1 (en) | 2003-09-03 | 2011-03-04 | Stents and stent grafts |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/699,701 Continuation US8007605B2 (en) | 2003-09-03 | 2007-01-30 | Method of forming a non-circular stent |
Publications (1)
Publication Number | Publication Date |
---|---|
US20110208288A1 true US20110208288A1 (en) | 2011-08-25 |
Family
ID=34222399
Family Applications (15)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/784,462 Expired - Lifetime US8292943B2 (en) | 2003-09-03 | 2004-02-23 | Stent graft with longitudinal support member |
US11/348,176 Active 2028-05-22 US8308790B2 (en) | 2003-09-03 | 2006-02-06 | Two-part expanding stent graft delivery system |
US11/449,337 Active 2027-08-26 US8740963B2 (en) | 2003-09-03 | 2006-06-08 | Methods of implanting a prosthesis and treating an aneurysm |
US11/699,700 Abandoned US20070203566A1 (en) | 2003-09-03 | 2007-01-30 | Non-circular stent |
US11/699,701 Active 2027-01-24 US8007605B2 (en) | 2003-09-03 | 2007-01-30 | Method of forming a non-circular stent |
US11/700,609 Active 2028-04-08 US9320631B2 (en) | 2003-09-03 | 2007-01-31 | Aligning device for stent graft delivery system |
US11/700,510 Active 2027-07-02 US8062349B2 (en) | 2003-09-03 | 2007-01-31 | Method for aligning a stent graft delivery system |
US13/040,755 Abandoned US20110208288A1 (en) | 2003-09-03 | 2011-03-04 | Stents and stent grafts |
US13/566,412 Expired - Lifetime US8636788B2 (en) | 2003-09-03 | 2012-08-03 | Methods of implanting a prosthesis |
US14/105,751 Expired - Lifetime US9408734B2 (en) | 2003-09-03 | 2013-12-13 | Methods of implanting a prosthesis |
US14/157,194 Expired - Lifetime US9408735B2 (en) | 2003-09-03 | 2014-01-16 | Methods of implanting a prosthesis and treating an aneurysm |
US15/099,974 Expired - Lifetime US10182930B2 (en) | 2003-09-03 | 2016-04-15 | Aligning device for stent graft delivery system |
US15/217,464 Expired - Lifetime US9925080B2 (en) | 2003-09-03 | 2016-07-22 | Methods of implanting a prosthesis |
US15/217,486 Expired - Lifetime US9913743B2 (en) | 2003-09-03 | 2016-07-22 | Methods of implanting a prosthesis and treating an aneurysm |
US16/222,820 Expired - Lifetime US10918509B2 (en) | 2003-09-03 | 2018-12-17 | Aligning device for stent graft delivery system |
Family Applications Before (7)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/784,462 Expired - Lifetime US8292943B2 (en) | 2003-09-03 | 2004-02-23 | Stent graft with longitudinal support member |
US11/348,176 Active 2028-05-22 US8308790B2 (en) | 2003-09-03 | 2006-02-06 | Two-part expanding stent graft delivery system |
US11/449,337 Active 2027-08-26 US8740963B2 (en) | 2003-09-03 | 2006-06-08 | Methods of implanting a prosthesis and treating an aneurysm |
US11/699,700 Abandoned US20070203566A1 (en) | 2003-09-03 | 2007-01-30 | Non-circular stent |
US11/699,701 Active 2027-01-24 US8007605B2 (en) | 2003-09-03 | 2007-01-30 | Method of forming a non-circular stent |
US11/700,609 Active 2028-04-08 US9320631B2 (en) | 2003-09-03 | 2007-01-31 | Aligning device for stent graft delivery system |
US11/700,510 Active 2027-07-02 US8062349B2 (en) | 2003-09-03 | 2007-01-31 | Method for aligning a stent graft delivery system |
Family Applications After (7)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US13/566,412 Expired - Lifetime US8636788B2 (en) | 2003-09-03 | 2012-08-03 | Methods of implanting a prosthesis |
US14/105,751 Expired - Lifetime US9408734B2 (en) | 2003-09-03 | 2013-12-13 | Methods of implanting a prosthesis |
US14/157,194 Expired - Lifetime US9408735B2 (en) | 2003-09-03 | 2014-01-16 | Methods of implanting a prosthesis and treating an aneurysm |
US15/099,974 Expired - Lifetime US10182930B2 (en) | 2003-09-03 | 2016-04-15 | Aligning device for stent graft delivery system |
US15/217,464 Expired - Lifetime US9925080B2 (en) | 2003-09-03 | 2016-07-22 | Methods of implanting a prosthesis |
US15/217,486 Expired - Lifetime US9913743B2 (en) | 2003-09-03 | 2016-07-22 | Methods of implanting a prosthesis and treating an aneurysm |
US16/222,820 Expired - Lifetime US10918509B2 (en) | 2003-09-03 | 2018-12-17 | Aligning device for stent graft delivery system |
Country Status (11)
Country | Link |
---|---|
US (15) | US8292943B2 (en) |
EP (1) | EP1673033B1 (en) |
KR (1) | KR101260518B1 (en) |
AT (1) | ATE430536T1 (en) |
AU (1) | AU2004270186B2 (en) |
BR (1) | BRPI0414109B8 (en) |
DE (1) | DE602004021041D1 (en) |
DK (1) | DK1776938T3 (en) |
ES (1) | ES2327150T3 (en) |
IL (1) | IL174066A (en) |
WO (1) | WO2005023149A2 (en) |
Cited By (24)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080077226A1 (en) * | 2003-09-03 | 2008-03-27 | Bolton Medical, Inc. | Stent Graft Delivery System Handle |
US20080264102A1 (en) * | 2004-02-23 | 2008-10-30 | Bolton Medical, Inc. | Sheath Capture Device for Stent Graft Delivery System and Method for Operating Same |
US20100030255A1 (en) * | 2008-06-30 | 2010-02-04 | Humberto Berra | Abdominal aortic aneurysms: systems and methods of use |
US20100274350A1 (en) * | 2009-04-22 | 2010-10-28 | Medinol Ltd. | Helical hybrid stent |
US8062349B2 (en) | 2003-09-03 | 2011-11-22 | Bolton Medical, Inc. | Method for aligning a stent graft delivery system |
US20120197376A1 (en) * | 2011-02-01 | 2012-08-02 | Aga Medical Corporation | Vascular delivery system and method |
US8500792B2 (en) | 2003-09-03 | 2013-08-06 | Bolton Medical, Inc. | Dual capture device for stent graft delivery system and method for capturing a stent graft |
US20140257362A1 (en) * | 2013-03-07 | 2014-09-11 | St. Jude Medical, Cardiology Division, Inc. | Filtering and removing particulates from bloodstream |
US8998970B2 (en) | 2012-04-12 | 2015-04-07 | Bolton Medical, Inc. | Vascular prosthetic delivery device and method of use |
US9101506B2 (en) | 2009-03-13 | 2015-08-11 | Bolton Medical, Inc. | System and method for deploying an endoluminal prosthesis at a surgical site |
US9173755B2 (en) | 2003-09-03 | 2015-11-03 | Bolton Medical, Inc. | Vascular repair devices |
US9439751B2 (en) | 2013-03-15 | 2016-09-13 | Bolton Medical, Inc. | Hemostasis valve and delivery systems |
US9456910B2 (en) | 2003-06-27 | 2016-10-04 | Medinol Ltd. | Helical hybrid stent |
US9592112B2 (en) | 2011-11-16 | 2017-03-14 | Bolton Medical, Inc. | Device and method for aortic branched vessel repair |
US9907640B2 (en) | 2013-06-21 | 2018-03-06 | Boston Scientific Scimed, Inc. | Stent with deflecting connector |
US9956320B2 (en) | 2003-06-27 | 2018-05-01 | Zuli Holdings Ltd. | Amorphous metal alloy medical devices |
US10390932B2 (en) | 2016-04-05 | 2019-08-27 | Bolton Medical, Inc. | Stent graft with internal tunnels and fenestrations and methods of use |
CN110520082A (en) * | 2017-03-06 | 2019-11-29 | 心血管实验室股份公司和布雷维蒙特 Cv 实验室股份公司 | Multilayer endoluminal prosthesis component and its manufacturing method |
US10524893B2 (en) | 2014-09-23 | 2020-01-07 | Bolton Medical, Inc. | Vascular repair devices and methods of use |
US10646365B2 (en) | 2003-09-03 | 2020-05-12 | Bolton Medical, Inc. | Delivery system and method for self-centering a proximal end of a stent graft |
US11259945B2 (en) | 2003-09-03 | 2022-03-01 | Bolton Medical, Inc. | Dual capture device for stent graft delivery system and method for capturing a stent graft |
US11395750B2 (en) | 2016-05-25 | 2022-07-26 | Bolton Medical, Inc. | Stent grafts and methods of use for treating aneurysms |
US11446167B2 (en) | 2011-11-11 | 2022-09-20 | Bolton Medical, Inc. | Universal endovascular grafts |
US11596537B2 (en) | 2003-09-03 | 2023-03-07 | Bolton Medical, Inc. | Delivery system and method for self-centering a proximal end of a stent graft |
Families Citing this family (214)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20100318174A1 (en) * | 1998-12-11 | 2010-12-16 | Endologix, Inc. | Implantable vascular graft |
US7147656B2 (en) * | 2001-12-03 | 2006-12-12 | Xtent, Inc. | Apparatus and methods for delivery of braided prostheses |
US7147661B2 (en) | 2001-12-20 | 2006-12-12 | Boston Scientific Santa Rosa Corp. | Radially expandable stent |
US11890181B2 (en) | 2002-07-22 | 2024-02-06 | Tmt Systems, Inc. | Percutaneous endovascular apparatus for repair of aneurysms and arterial blockages |
US8465536B2 (en) * | 2004-04-06 | 2013-06-18 | Cook Medical Technologies Llc | Prosthesis deployment system |
US20050246008A1 (en) * | 2004-04-30 | 2005-11-03 | Novostent Corporation | Delivery system for vascular prostheses and methods of use |
US8267985B2 (en) * | 2005-05-25 | 2012-09-18 | Tyco Healthcare Group Lp | System and method for delivering and deploying an occluding device within a vessel |
US20060206200A1 (en) | 2004-05-25 | 2006-09-14 | Chestnut Medical Technologies, Inc. | Flexible vascular occluding device |
US8623067B2 (en) | 2004-05-25 | 2014-01-07 | Covidien Lp | Methods and apparatus for luminal stenting |
CA2758946C (en) | 2004-05-25 | 2014-10-21 | Tyco Healthcare Group Lp | Vascular stenting for aneurysms |
JP2008502378A (en) | 2004-05-25 | 2008-01-31 | チェストナット メディカル テクノロジーズ インコーポレイテッド | Flexible vascular closure device |
JP4844394B2 (en) * | 2004-06-25 | 2011-12-28 | 日本ゼオン株式会社 | Stent |
DE602005024585D1 (en) * | 2004-09-28 | 2010-12-16 | Cook William Europ | DEVICE FOR TREATING AORTIAL DISEASE |
US20060155366A1 (en) * | 2005-01-10 | 2006-07-13 | Laduca Robert | Apparatus and method for deploying an implantable device within the body |
US8128680B2 (en) | 2005-01-10 | 2012-03-06 | Taheri Laduca Llc | Apparatus and method for deploying an implantable device within the body |
US8287583B2 (en) * | 2005-01-10 | 2012-10-16 | Taheri Laduca Llc | Apparatus and method for deploying an implantable device within the body |
US20070150051A1 (en) * | 2005-01-10 | 2007-06-28 | Duke Fiduciary, Llc | Vascular implants and methods of fabricating the same |
DE102005003632A1 (en) | 2005-01-20 | 2006-08-17 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. | Catheter for the transvascular implantation of heart valve prostheses |
EP1879520B1 (en) | 2005-05-09 | 2013-03-13 | Angiomed GmbH & Co. Medizintechnik KG | Implant delivery device |
EP1906879B1 (en) | 2005-07-27 | 2013-11-06 | Cook Medical Technologies LLC | Stent-graft device for open surgical placement |
US8043366B2 (en) * | 2005-09-08 | 2011-10-25 | Boston Scientific Scimed, Inc. | Overlapping stent |
KR100664531B1 (en) * | 2006-01-26 | 2007-01-04 | (주) 태웅메디칼 | Flexible self-expandable stent and methods for making the stent for lumen |
US8152833B2 (en) | 2006-02-22 | 2012-04-10 | Tyco Healthcare Group Lp | Embolic protection systems having radiopaque filter mesh |
DE102006053748B3 (en) * | 2006-11-09 | 2008-04-10 | Jotec Gmbh | Insert system for inserting and releasing e.g. endovascular stent, has fixing system with cover unit including pivoting units axially extending in proximal direction of insert system, and retaining unit arranged proximal to cover unit |
US7615072B2 (en) * | 2006-11-14 | 2009-11-10 | Medtronic Vascular, Inc. | Endoluminal prosthesis |
DE102006058186A1 (en) * | 2006-11-29 | 2008-06-05 | Jotec Gmbh | Proximal fixation |
BRPI0807261B8 (en) | 2007-02-09 | 2021-06-22 | Taheri Laduca Llc | stent-loaded catheter sets |
WO2008098252A2 (en) | 2007-02-09 | 2008-08-14 | Taheri Laduca Llc | Vascular implants and methods of fabricating the same |
JP4961517B2 (en) * | 2007-02-20 | 2012-06-27 | 国立大学法人福井大学 | Stent and therapeutic device for tubular organ using the same |
US7896915B2 (en) | 2007-04-13 | 2011-03-01 | Jenavalve Technology, Inc. | Medical device for treating a heart valve insufficiency |
WO2008140796A1 (en) | 2007-05-11 | 2008-11-20 | William A. Cook Australia Pty. Ltd. | Stent grafts for the thoracic aorta |
US8663309B2 (en) | 2007-09-26 | 2014-03-04 | Trivascular, Inc. | Asymmetric stent apparatus and method |
JP2010540190A (en) | 2007-10-04 | 2010-12-24 | トリバスキュラー・インコーポレイテッド | Modular vascular graft for low profile transdermal delivery |
US20090093870A1 (en) * | 2007-10-05 | 2009-04-09 | Bacoustics, Llc | Method for Holding a Medical Device During Coating |
US8689728B2 (en) * | 2007-10-05 | 2014-04-08 | Menendez Adolfo | Apparatus for holding a medical device during coating |
BRPI0819215A2 (en) | 2007-10-26 | 2015-05-05 | Cook Critical Care Inc | Vascular conductor and delivery system for open surgical placement |
BRPI0704464A2 (en) * | 2007-11-30 | 2009-07-28 | Melchiades Da Cunha Neto | endoprosthesis, delivery system within a patient's vessel and uses of said delivery system and said endoprosthesis |
US9375327B2 (en) | 2007-12-12 | 2016-06-28 | Intact Vascular, Inc. | Endovascular implant |
US10166127B2 (en) | 2007-12-12 | 2019-01-01 | Intact Vascular, Inc. | Endoluminal device and method |
US8128677B2 (en) | 2007-12-12 | 2012-03-06 | Intact Vascular LLC | Device and method for tacking plaque to a blood vessel wall |
US7896911B2 (en) | 2007-12-12 | 2011-03-01 | Innovasc Llc | Device and method for tacking plaque to blood vessel wall |
US10022250B2 (en) | 2007-12-12 | 2018-07-17 | Intact Vascular, Inc. | Deployment device for placement of multiple intraluminal surgical staples |
US9603730B2 (en) | 2007-12-12 | 2017-03-28 | Intact Vascular, Inc. | Endoluminal device and method |
US8992593B2 (en) * | 2007-12-26 | 2015-03-31 | Cook Medical Technologies Llc | Apparatus and methods for deployment of a modular stent-graft system |
US9180030B2 (en) | 2007-12-26 | 2015-11-10 | Cook Medical Technologies Llc | Low profile non-symmetrical stent |
GB2476451A (en) * | 2009-11-19 | 2011-06-29 | Cook William Europ | Stent Graft |
US8574284B2 (en) * | 2007-12-26 | 2013-11-05 | Cook Medical Technologies Llc | Low profile non-symmetrical bare alignment stents with graft |
GB2475494B (en) | 2009-11-18 | 2011-11-23 | Cook William Europ | Stent graft and introducer assembly |
US8728145B2 (en) * | 2008-12-11 | 2014-05-20 | Cook Medical Technologies Llc | Low profile non-symmetrical stents and stent-grafts |
US9226813B2 (en) | 2007-12-26 | 2016-01-05 | Cook Medical Technologies Llc | Low profile non-symmetrical stent |
US8845712B2 (en) | 2008-01-15 | 2014-09-30 | W. L. Gore & Associates, Inc. | Pleated deployment sheath |
BRPI0906759A2 (en) | 2008-01-16 | 2015-07-07 | St Jude Medical | Apparatus for providing a foldable and re-expandable prosthetic heart valve to an implant site in a patient and method for operating the same. |
WO2009102441A1 (en) * | 2008-02-11 | 2009-08-20 | William A. Cook Australia Pty. Ltd. | Curve forming apparatus and curvable stent graft |
US9044318B2 (en) | 2008-02-26 | 2015-06-02 | Jenavalve Technology Gmbh | Stent for the positioning and anchoring of a valvular prosthesis |
ES2903231T3 (en) | 2008-02-26 | 2022-03-31 | Jenavalve Tech Inc | Stent for positioning and anchoring a valve prosthesis at an implantation site in a patient's heart |
US10813779B2 (en) * | 2008-04-25 | 2020-10-27 | CARDINAL HEALTH SWITZERLAND 515 GmbH | Stent attachment and deployment mechanism |
US20090276027A1 (en) * | 2008-05-01 | 2009-11-05 | Medtronic Vasscular, Inc. | Stent Graft Delivery System and Method of Use |
CA2835521C (en) * | 2008-06-04 | 2016-04-19 | Gore Enterprise Holdings, Inc. | Controlled deployable medical device and method of making the same |
US20100049293A1 (en) * | 2008-06-04 | 2010-02-25 | Zukowski Stanislaw L | Controlled deployable medical device and method of making the same |
EP2293838B1 (en) | 2008-07-01 | 2012-08-08 | Endologix, Inc. | Catheter system |
US8057507B2 (en) | 2009-01-16 | 2011-11-15 | Novate Medical Limited | Vascular filter |
EP2460491B2 (en) | 2009-01-16 | 2023-11-29 | Novate Medical Ltd. | A vascular filter |
US8858610B2 (en) | 2009-01-19 | 2014-10-14 | W. L. Gore & Associates, Inc. | Forced deployment sequence |
US20100268315A1 (en) * | 2009-04-17 | 2010-10-21 | Medtronic Vascular, Inc. | Castellated Sleeve Stent-Graft Delivery System and Method |
GB2470041B (en) * | 2009-05-06 | 2011-05-18 | Cook William Europ | Stent graft |
CN101897629B (en) * | 2009-05-26 | 2013-08-07 | 上海微创医疗器械(集团)有限公司 | Branched membrane-covered support conveying system and conveying method thereof |
AU2015203704B2 (en) * | 2009-06-23 | 2017-03-02 | Cardinal Health 529, Llc | Endoprosthesis delivery system |
US8771333B2 (en) | 2009-06-23 | 2014-07-08 | Cordis Corporation | Stent-graft securement device |
US8936634B2 (en) | 2009-07-15 | 2015-01-20 | W. L. Gore & Associates, Inc. | Self constraining radially expandable medical devices |
US8435282B2 (en) | 2009-07-15 | 2013-05-07 | W. L. Gore & Associates, Inc. | Tube with reverse necking properties |
US9757263B2 (en) | 2009-11-18 | 2017-09-12 | Cook Medical Technologies Llc | Stent graft and introducer assembly |
US20110218609A1 (en) * | 2010-02-10 | 2011-09-08 | Trivascular, Inc. | Fill tube manifold and delivery methods for endovascular graft |
JP2013524870A (en) * | 2010-03-22 | 2013-06-20 | サイテック プロドゥトス メディコス リミターダ | Delivery system for delivering endoprostheses and endoprostheses into the vasculature of a patient |
US8579963B2 (en) * | 2010-04-13 | 2013-11-12 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery device with stability tube and method |
US8764811B2 (en) | 2010-04-20 | 2014-07-01 | Medtronic Vascular, Inc. | Controlled tip release stent graft delivery system and method |
US8663305B2 (en) | 2010-04-20 | 2014-03-04 | Medtronic Vascular, Inc. | Retraction mechanism and method for graft cover retraction |
CN102917668B (en) * | 2010-04-27 | 2015-01-28 | 美敦力公司 | Transcatheter prosthetic heart valve delivery device with biased release features |
US8623064B2 (en) | 2010-04-30 | 2014-01-07 | Medtronic Vascular, Inc. | Stent graft delivery system and method of use |
US8747448B2 (en) | 2010-04-30 | 2014-06-10 | Medtronic Vascular, Inc. | Stent graft delivery system |
US10856978B2 (en) * | 2010-05-20 | 2020-12-08 | Jenavalve Technology, Inc. | Catheter system |
US11278406B2 (en) * | 2010-05-20 | 2022-03-22 | Jenavalve Technology, Inc. | Catheter system for introducing an expandable heart valve stent into the body of a patient, insertion system with a catheter system and medical device for treatment of a heart valve defect |
JP2013526388A (en) | 2010-05-25 | 2013-06-24 | イエナバルブ テクノロジー インク | Artificial heart valve, and transcatheter delivery prosthesis comprising an artificial heart valve and a stent |
US10130470B2 (en) | 2010-08-17 | 2018-11-20 | St. Jude Medical, Llc | Sleeve for facilitating movement of a transfemoral catheter |
US9439795B2 (en) | 2010-09-17 | 2016-09-13 | St. Jude Medical, Cardiology Division, Inc. | Retainers for transcatheter heart valve delivery systems |
US10603166B2 (en) * | 2010-09-20 | 2020-03-31 | St. Jude Medical, Cardiology Division, Inc. | Delivery device having a curved shaft and a straightening member for transcatheter aortic valve implantation |
WO2012068389A1 (en) | 2010-11-17 | 2012-05-24 | Boston Scientific Scimed, Inc. | Stent delivery system |
EP3238669B1 (en) | 2010-11-17 | 2020-11-04 | Boston Scientific Scimed, Inc. | Stent delivery systems |
CN103298432B (en) | 2010-11-17 | 2016-03-02 | 波士顿科学西美德公司 | stent delivery system |
US8911468B2 (en) * | 2011-01-31 | 2014-12-16 | Vatrix Medical, Inc. | Devices, therapeutic compositions and corresponding percutaneous treatment methods for aortic dissection |
JP6294669B2 (en) | 2011-03-01 | 2018-03-14 | エンドロジックス、インク | Catheter system and method of use thereof |
US9744033B2 (en) | 2011-04-01 | 2017-08-29 | W.L. Gore & Associates, Inc. | Elastomeric leaflet for prosthetic heart valves |
US10271973B2 (en) | 2011-06-03 | 2019-04-30 | Intact Vascular, Inc. | Endovascular implant |
US10117765B2 (en) | 2011-06-14 | 2018-11-06 | W.L. Gore Associates, Inc | Apposition fiber for use in endoluminal deployment of expandable implants |
US9370422B2 (en) | 2011-07-28 | 2016-06-21 | St. Jude Medical, Inc. | Expandable radiopaque marker for transcatheter aortic valve implantation |
US9554806B2 (en) | 2011-09-16 | 2017-01-31 | W. L. Gore & Associates, Inc. | Occlusive devices |
US10058443B2 (en) | 2011-11-02 | 2018-08-28 | Boston Scientific Scimed, Inc. | Stent delivery systems and methods for use |
US8728148B2 (en) | 2011-11-09 | 2014-05-20 | Cook Medical Technologies Llc | Diameter reducing tie arrangement for endoluminal prosthesis |
US9782282B2 (en) | 2011-11-14 | 2017-10-10 | W. L. Gore & Associates, Inc. | External steerable fiber for use in endoluminal deployment of expandable devices |
US9877858B2 (en) | 2011-11-14 | 2018-01-30 | W. L. Gore & Associates, Inc. | External steerable fiber for use in endoluminal deployment of expandable devices |
US9168162B2 (en) | 2011-11-17 | 2015-10-27 | Elgco, Llc | Methods and apparatus for treating a type 2 endoleak from within an endoluminal stent |
US9220620B2 (en) * | 2011-11-22 | 2015-12-29 | Cook Medical Technologies Llc | Endoluminal prosthesis introducer |
US9408952B2 (en) * | 2011-11-30 | 2016-08-09 | Abbott Cardiovascular Systems Inc. | Pediatric application of bioabsorbable polymer stents in infants and children with congenital heart defects |
EP2806826B1 (en) | 2012-01-25 | 2020-01-08 | Intact Vascular, Inc. | Endoluminal device |
US9375308B2 (en) | 2012-03-13 | 2016-06-28 | W. L. Gore & Associates, Inc. | External steerable fiber for use in endoluminal deployment of expandable devices |
US8992595B2 (en) | 2012-04-04 | 2015-03-31 | Trivascular, Inc. | Durable stent graft with tapered struts and stable delivery methods and devices |
US9498363B2 (en) | 2012-04-06 | 2016-11-22 | Trivascular, Inc. | Delivery catheter for endovascular device |
US9220616B2 (en) | 2012-04-13 | 2015-12-29 | Medtronic Vascular, Inc. | Stent-graft delivery system having a rotatable single shaft tip capture mechanism |
US9700399B2 (en) | 2012-04-26 | 2017-07-11 | Medtronic Vascular, Inc. | Stopper to prevent graft material slippage in a closed web stent-graft |
US8882828B2 (en) * | 2012-04-27 | 2014-11-11 | Medtronic Vascular, Inc. | Ring on a closed web stent-graft for use in tip capture |
US8968384B2 (en) * | 2012-04-27 | 2015-03-03 | Medtronic Vascular, Inc. | Circumferentially constraining sutures for a stent-graft |
US9173756B2 (en) | 2012-06-13 | 2015-11-03 | Cook Medical Technologies Llc | Systems and methods for deploying a portion of a stent using at least one coiled member |
US9144510B2 (en) | 2012-06-13 | 2015-09-29 | Cook Medical Technologies Llc | Systems and methods for deploying a portion of a stent using at least one coiled member |
US9233015B2 (en) | 2012-06-15 | 2016-01-12 | Trivascular, Inc. | Endovascular delivery system with an improved radiopaque marker scheme |
US9480561B2 (en) | 2012-06-26 | 2016-11-01 | St. Jude Medical, Cardiology Division, Inc. | Apparatus and method for aortic protection and TAVI planar alignment |
US9918837B2 (en) | 2012-06-29 | 2018-03-20 | St. Jude Medical, Cardiology Division, Inc. | System to assist in the release of a collapsible stent from a delivery device |
EP2710985A3 (en) * | 2012-09-20 | 2016-01-13 | Biotronik AG | Implant, system formed of an implant and a catheter, and method for producing such a system |
GB2512016A (en) | 2012-09-24 | 2014-09-24 | Arterius Ltd | Methods |
US9114001B2 (en) | 2012-10-30 | 2015-08-25 | Covidien Lp | Systems for attaining a predetermined porosity of a vascular device |
US9452070B2 (en) | 2012-10-31 | 2016-09-27 | Covidien Lp | Methods and systems for increasing a density of a region of a vascular device |
US9943427B2 (en) | 2012-11-06 | 2018-04-17 | Covidien Lp | Shaped occluding devices and methods of using the same |
US20140135907A1 (en) * | 2012-11-09 | 2014-05-15 | Medtronic CV Luxembourg S.a.r.l. | Medical Device Delivery System and Methods of Delivering Medical Devices |
AU2012258395B1 (en) * | 2012-11-27 | 2013-03-28 | Cook Medical Technologies Llc | Assembly of stent grafts with diameter reducing ties |
US8978420B2 (en) | 2012-12-14 | 2015-03-17 | Ppg Industries Ohio, Inc. | Bending device for shaping glass for use in aircraft transparencies |
US9687373B2 (en) | 2012-12-21 | 2017-06-27 | Cook Medical Technologies Llc | Systems and methods for securing and releasing a portion of a stent |
US9655756B2 (en) | 2012-12-21 | 2017-05-23 | Cook Medical Technologies Llc | Systems and methods for deploying a portion of a stent using an auger-style device |
US9157174B2 (en) | 2013-02-05 | 2015-10-13 | Covidien Lp | Vascular device for aneurysm treatment and providing blood flow into a perforator vessel |
US9095463B2 (en) | 2013-02-21 | 2015-08-04 | Medtronic Vascular, Inc. | Stent-graft delivery having a tip capture mechanism with elongated cables for gradual deployment and repositioning |
US9339385B2 (en) | 2013-03-07 | 2016-05-17 | St. Jude Medical, Cardiology Division, Inc. | Balloon release mechanism for TAVI implant |
BR112015023266A2 (en) | 2013-03-15 | 2017-07-18 | Bolton Medical Inc | hemostasis valve and shipping systems |
US9498364B2 (en) | 2013-03-29 | 2016-11-22 | Cook Medical Technologies Llc | Medical device delivery system and method of flushing same |
US11911258B2 (en) | 2013-06-26 | 2024-02-27 | W. L. Gore & Associates, Inc. | Space filling devices |
US10245137B2 (en) | 2013-07-22 | 2019-04-02 | Atrium Medical Corporation | Graft with expandable region and methods of making and using the same |
EP2832322A1 (en) * | 2013-07-30 | 2015-02-04 | Nvt Ag | Deployment system for a cardiac valve prosthesis |
JP6563394B2 (en) | 2013-08-30 | 2019-08-21 | イェーナヴァルヴ テクノロジー インコーポレイテッド | Radially foldable frame for an artificial valve and method for manufacturing the frame |
EP3043755B1 (en) | 2013-09-12 | 2022-10-19 | St. Jude Medical, Cardiology Division, Inc. | Atraumatic interface in an implant delivery device |
CN104622607B (en) * | 2013-11-07 | 2017-11-21 | 微创心脉医疗科技(上海)有限公司 | The induction system of abdominal aorta support |
CN104706449B (en) * | 2013-12-17 | 2017-11-07 | 微创心脉医疗科技(上海)有限公司 | A kind of stent delivery system and component is discharged thereafter |
US20170049596A1 (en) * | 2014-04-30 | 2017-02-23 | Stryker Corporation | Implant delivery system and method of use |
GB201411486D0 (en) * | 2014-06-27 | 2014-08-13 | Isis Innovation | Apparatus for providing and maintaining access to a surgical site |
US10195064B2 (en) | 2014-08-15 | 2019-02-05 | W. L. Gore & Associates, Inc. | Endoprosthesis delivery systems with improved retraction |
US9827124B2 (en) * | 2014-12-05 | 2017-11-28 | Cook Medical Technologies Llc | Magnetic handle assembly for prosthesis delivery device |
US9980840B2 (en) * | 2014-12-08 | 2018-05-29 | Cook Medical Technologies Llc | Delivery device with an expandable positioner for positioning a prosthesis |
US10159587B2 (en) | 2015-01-16 | 2018-12-25 | Boston Scientific Scimed, Inc. | Medical device delivery system with force reduction member |
US9433520B2 (en) | 2015-01-29 | 2016-09-06 | Intact Vascular, Inc. | Delivery device and method of delivery |
US9375336B1 (en) | 2015-01-29 | 2016-06-28 | Intact Vascular, Inc. | Delivery device and method of delivery |
CN107530168B (en) | 2015-05-01 | 2020-06-09 | 耶拿阀门科技股份有限公司 | Device and method with reduced pacemaker ratio in heart valve replacement |
US20180116832A1 (en) | 2015-05-08 | 2018-05-03 | Jayandiran Pillai | Stent and stent set |
EP3977945A1 (en) | 2015-05-14 | 2022-04-06 | W. L. Gore & Associates, Inc. | Devices for occlusion of an atrial appendage |
EP4417169A2 (en) | 2015-06-30 | 2024-08-21 | Endologix LLC | Locking assembly for coupling guidewire to delivery system |
EP3328326A4 (en) * | 2015-07-30 | 2019-03-20 | TriVascular, Inc. | Endoluminal prosthesis deployment devices and methods |
US10172733B2 (en) | 2015-09-01 | 2019-01-08 | Cook Medical Technologies Llc | Modular handle for a prosthesis delivery device |
EP4327786A3 (en) * | 2015-09-18 | 2024-05-01 | Terumo Corporation | Pushable implant delivery system |
US11351048B2 (en) | 2015-11-16 | 2022-06-07 | Boston Scientific Scimed, Inc. | Stent delivery systems with a reinforced deployment sheath |
US10993824B2 (en) | 2016-01-01 | 2021-05-04 | Intact Vascular, Inc. | Delivery device and method of delivery |
JP6686156B2 (en) | 2016-02-26 | 2020-04-22 | ボストン サイエンティフィック サイムド,インコーポレイテッドBoston Scientific Scimed,Inc. | Methods of manufacturing medical devices and stent delivery systems |
WO2017176678A1 (en) | 2016-04-05 | 2017-10-12 | Bolton Medical, Inc. | Delivery device with filler tubes |
WO2017176674A1 (en) | 2016-04-05 | 2017-10-12 | Bolton Medical, Inc. | Delivery systems with introducer and distal sheaths and methods of use |
EP3454794B1 (en) | 2016-05-13 | 2021-04-14 | St. Jude Medical, Cardiology Division, Inc. | Systems for device implantation |
EP3454795B1 (en) | 2016-05-13 | 2023-01-11 | JenaValve Technology, Inc. | Heart valve prosthesis delivery system for delivery of heart valve prosthesis with introducer sheath and loading system |
US20170325952A1 (en) * | 2016-05-13 | 2017-11-16 | Boston Scientific Scimed, Inc. | Implant release system |
US10905329B2 (en) | 2016-06-09 | 2021-02-02 | Biosense Webster (Israel) Ltd. | Multi-function conducting elements for a catheter |
CN107550524B (en) * | 2016-07-01 | 2020-01-03 | 先健科技(深圳)有限公司 | Conveying device |
CN207708054U (en) * | 2016-07-29 | 2018-08-10 | 上海沃比医疗科技有限公司 | Implantation material transport system |
EP4403144A3 (en) | 2016-08-02 | 2024-09-25 | Bolton Medical, Inc. | Systems, devices, and methods for coupling a prosthetic implant to a fenestrated body |
US20180206972A1 (en) | 2016-08-10 | 2018-07-26 | Bolton Medical, Inc. | Graft prosthesis coupler, modular system, and methods of use |
GB201616092D0 (en) * | 2016-09-21 | 2016-11-02 | Imp Innovations Ltd | Apparatus for securing a device in a vascular lumen |
US11426276B2 (en) | 2016-10-12 | 2022-08-30 | Medtronic Vascular, Inc. | Stented prosthetic heart valve delivery system having an expandable bumper |
US11400205B2 (en) | 2016-11-23 | 2022-08-02 | Biosense Webster (Israel) Ltd. | Balloon-in-balloon irrigation balloon catheter |
JP7094965B2 (en) | 2017-01-27 | 2022-07-04 | イエナバルブ テクノロジー インク | Heart valve imitation |
EP3585306B1 (en) | 2017-02-24 | 2021-01-27 | Bolton Medical, Inc. | System to radially constrict a stent graft |
EP3534848B1 (en) | 2017-02-24 | 2023-06-28 | Bolton Medical, Inc. | Stent graft delivery system with constricted sheath |
WO2018156848A1 (en) | 2017-02-24 | 2018-08-30 | Bolton Medical, Inc. | Vascular prosthesis with crimped adapter and methods of use |
WO2018156851A1 (en) | 2017-02-24 | 2018-08-30 | Bolton Medical, Inc. | Vascular prosthesis with moveable fenestration |
WO2018156847A1 (en) | 2017-02-24 | 2018-08-30 | Bolton Medical, Inc. | Delivery system and method to radially constrict a stent graft |
EP3534838B1 (en) | 2017-02-24 | 2021-01-27 | Bolton Medical, Inc. | Radially adjustable stent graft delivery system |
CN110022795B (en) | 2017-02-24 | 2023-03-14 | 波顿医疗公司 | Constrained stent grafts, delivery systems and methods of use |
WO2018156850A1 (en) | 2017-02-24 | 2018-08-30 | Bolton Medical, Inc. | Stent graft with fenestration lock |
WO2018156849A1 (en) | 2017-02-24 | 2018-08-30 | Bolton Medical, Inc. | Vascular prosthesis with fenestration ring and methods of use |
EP3585320B1 (en) | 2017-02-24 | 2022-07-27 | Bolton Medical, Inc. | Delivery system for radially constricting a stent graft |
EP3618734B1 (en) | 2017-05-03 | 2021-06-30 | Medtronic Vascular, Inc. | Tissue-removing catheter |
US11690645B2 (en) | 2017-05-03 | 2023-07-04 | Medtronic Vascular, Inc. | Tissue-removing catheter |
US12029545B2 (en) | 2017-05-30 | 2024-07-09 | Biosense Webster (Israel) Ltd. | Catheter splines as location sensors |
US11660218B2 (en) | 2017-07-26 | 2023-05-30 | Intact Vascular, Inc. | Delivery device and method of delivery |
CN111148484B (en) | 2017-09-25 | 2022-12-30 | 波尔顿医疗公司 | Systems, devices, and methods for coupling a prosthetic implant to an open window |
CN109567981B (en) * | 2017-09-29 | 2024-09-20 | 上海微创心脉医疗科技股份有限公司 | Support system, conveying device thereof, rear release structure and support |
US11173023B2 (en) | 2017-10-16 | 2021-11-16 | W. L. Gore & Associates, Inc. | Medical devices and anchors therefor |
EP4049633A1 (en) * | 2017-10-31 | 2022-08-31 | Bolton Medical, Inc. | Distal torque component, delivery system and method of using same |
CN109984862A (en) * | 2017-12-29 | 2019-07-09 | 杭州唯强医疗科技有限公司 | A kind of aorta tectorial membrane stent that can be discharged step by step |
US11013627B2 (en) | 2018-01-10 | 2021-05-25 | Boston Scientific Scimed, Inc. | Stent delivery system with displaceable deployment mechanism |
US11123208B2 (en) | 2018-03-29 | 2021-09-21 | Medtronic Vascular, Inc. | Prosthesis delivery system with tip travel limiter and method of use |
WO2019236578A1 (en) | 2018-06-05 | 2019-12-12 | Boston Scientific Scimed, Inc. | Stent with selectively curved region |
EP3917461A2 (en) | 2019-02-01 | 2021-12-08 | Bolton Medical, Inc. | Expandable luminal stents and methods of use |
WO2020168117A1 (en) | 2019-02-13 | 2020-08-20 | Boston Scientific Scimed, Inc. | Stent delivery systems |
CN113853178A (en) | 2019-03-20 | 2021-12-28 | Inqb8医疗科技有限责任公司 | Aortic dissection implant |
US11819236B2 (en) | 2019-05-17 | 2023-11-21 | Medtronic Vascular, Inc. | Tissue-removing catheter |
USD969138S1 (en) | 2019-05-31 | 2022-11-08 | Biosense Webster (Israel) Ltd. | Display screen with a graphical user interface |
USD968421S1 (en) | 2019-05-31 | 2022-11-01 | Biosense Webster (Israel) Ltd. | Display screen with a graphical user interface |
USD968422S1 (en) | 2019-05-31 | 2022-11-01 | Biosense Webster (Israel) Ltd. | Display screen with transitional graphical user interface |
CN110151357A (en) * | 2019-06-27 | 2019-08-23 | 深圳市创心医疗科技有限公司 | Support system and intravascular stent |
US11273025B2 (en) * | 2019-11-22 | 2022-03-15 | Pro Verum Limited | Expandable implant delivery device |
US11602621B2 (en) | 2019-11-22 | 2023-03-14 | ProVerum Limited | Device for controllably deploying expandable implants |
CN112891033B (en) * | 2019-12-03 | 2023-07-04 | 先健科技(深圳)有限公司 | Lumen stent |
CN211356087U (en) * | 2019-12-19 | 2020-08-28 | 深圳市创心医疗科技有限公司 | Stent system and blood vessel stent |
CN113081387B (en) * | 2019-12-23 | 2023-12-05 | 先健科技(深圳)有限公司 | Covered stent, covered stent conveying system and covered stent loading method |
US11964114B2 (en) | 2020-05-22 | 2024-04-23 | Acclarent, Inc. | Shaft deflection control assembly for ENT guide instrument |
US11974803B2 (en) | 2020-10-12 | 2024-05-07 | Biosense Webster (Israel) Ltd. | Basket catheter with balloon |
EP4240281A1 (en) | 2020-11-09 | 2023-09-13 | Bolton Medical, Inc. | Aortic prosthesis delivery system and method of use |
US11957852B2 (en) | 2021-01-14 | 2024-04-16 | Biosense Webster (Israel) Ltd. | Intravascular balloon with slidable central irrigation tube |
US11786388B2 (en) | 2021-03-12 | 2023-10-17 | Cook Medical Technologies Llc | Endovascular delivery systems with radial orientation mechanisms |
US20220346931A1 (en) * | 2021-05-03 | 2022-11-03 | Adient Medical, Inc. | Delivery system for a medical device |
WO2022240680A1 (en) | 2021-05-11 | 2022-11-17 | Bolton Medical, Inc. | Aortic prosthesis delivery device and method of use |
CN113069258B (en) * | 2021-06-07 | 2022-02-08 | 上海微创心脉医疗科技(集团)股份有限公司 | Conveyor and medical device |
JP2024527888A (en) | 2021-07-26 | 2024-07-26 | ボルトン メディカル インコーポレイテッド | Aortic prosthesis with tunnel graft and embolic filter |
AU2022410616A1 (en) | 2021-12-16 | 2024-07-04 | Bolton Medical, Inc. | Stent graft crimping device and method of use |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5292331A (en) * | 1989-08-24 | 1994-03-08 | Applied Vascular Engineering, Inc. | Endovascular support device |
US5902334A (en) * | 1993-04-22 | 1999-05-11 | C.R. Bard, Inc. | Method and apparatus for recapture of hooked endoprosthesis |
US6355056B1 (en) * | 1995-06-01 | 2002-03-12 | Meadox Medicals, Inc. | Implantable intraluminal prosthesis |
US20020138133A1 (en) * | 1999-11-09 | 2002-09-26 | Scimed Life Systems, Inc. | Stent with variable properties |
Family Cites Families (484)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3416531A (en) | 1964-01-02 | 1968-12-17 | Edwards Miles Lowell | Catheter |
US3502069A (en) | 1965-10-20 | 1970-03-24 | Daniel Silverman | Method and apparatus for placing in and retrieving a tubular probe from a body cavity |
US3485234A (en) | 1966-04-13 | 1969-12-23 | Cordis Corp | Tubular products and method of making same |
US3868956A (en) | 1972-06-05 | 1975-03-04 | Ralph J Alfidi | Vessel implantable appliance and method of implanting it |
US4351333A (en) | 1975-10-28 | 1982-09-28 | Harrison Lazarus | Peritoneal fluid treatment apparatus, package and method |
US4425919A (en) | 1981-07-27 | 1984-01-17 | Raychem Corporation | Torque transmitting catheter apparatus |
US4515593A (en) | 1981-12-31 | 1985-05-07 | C. R. Bard, Inc. | Medical tubing having exterior hydrophilic coating for microbiocide absorption therein and method for using same |
US4516972A (en) | 1982-01-28 | 1985-05-14 | Advanced Cardiovascular Systems, Inc. | Guiding catheter and method of manufacture |
US4487808A (en) | 1982-04-22 | 1984-12-11 | Astra Meditec Aktiebolag | Medical article having a hydrophilic coating |
US4534363A (en) | 1982-04-29 | 1985-08-13 | Cordis Corporation | Coating for angiographic guidewire |
SE445884B (en) | 1982-04-30 | 1986-07-28 | Medinvent Sa | DEVICE FOR IMPLANTATION OF A RODFORM PROTECTION |
US5190546A (en) | 1983-10-14 | 1993-03-02 | Raychem Corporation | Medical devices incorporating SIM alloy elements |
US4665906A (en) | 1983-10-14 | 1987-05-19 | Raychem Corporation | Medical devices incorporating sim alloy elements |
US5067957A (en) | 1983-10-14 | 1991-11-26 | Raychem Corporation | Method of inserting medical devices incorporating SIM alloy elements |
US4572186A (en) | 1983-12-07 | 1986-02-25 | Cordis Corporation | Vessel dilation |
US5669936A (en) | 1983-12-09 | 1997-09-23 | Endovascular Technologies, Inc. | Endovascular grafting system and method for use therewith |
US7166125B1 (en) | 1988-03-09 | 2007-01-23 | Endovascular Technologies, Inc. | Intraluminal grafting system |
US5693083A (en) | 1983-12-09 | 1997-12-02 | Endovascular Technologies, Inc. | Thoracic graft and delivery catheter |
US4787899A (en) | 1983-12-09 | 1988-11-29 | Lazarus Harrison M | Intraluminal graft device, system and method |
US5104399A (en) | 1986-12-10 | 1992-04-14 | Endovascular Technologies, Inc. | Artificial graft and implantation method |
US6221102B1 (en) | 1983-12-09 | 2001-04-24 | Endovascular Technologies, Inc. | Intraluminal grafting system |
US4580568A (en) | 1984-10-01 | 1986-04-08 | Cook, Incorporated | Percutaneous endovascular stent and method for insertion thereof |
US4705511A (en) | 1985-05-13 | 1987-11-10 | Bipore, Inc. | Introducer sheath assembly |
US4634432A (en) | 1985-05-13 | 1987-01-06 | Nuri Kocak | Introducer sheath assembly |
US4665918A (en) | 1986-01-06 | 1987-05-19 | Garza Gilbert A | Prosthesis system and method |
US5041126A (en) | 1987-03-13 | 1991-08-20 | Cook Incorporated | Endovascular stent and delivery system |
US4817613A (en) | 1987-07-13 | 1989-04-04 | Devices For Vascular Intervention, Inc. | Guiding catheter |
US5254105A (en) | 1988-05-26 | 1993-10-19 | Haaga John R | Sheath for wound closure caused by a medical tubular device |
SE8803444D0 (en) | 1988-09-28 | 1988-09-28 | Medinvent Sa | A DEVICE FOR TRANSLUMINAL IMPLANTATION OR EXTRACTION |
US5290300A (en) | 1989-07-31 | 1994-03-01 | Baxter International Inc. | Flexible suture guide and holder |
US5019057A (en) | 1989-10-23 | 1991-05-28 | Cordis Corporation | Catheter having reinforcing strands |
US5176660A (en) | 1989-10-23 | 1993-01-05 | Cordis Corporation | Catheter having reinforcing strands |
US5176652A (en) | 1989-12-22 | 1993-01-05 | Cordis Corporation | Hemostasis valve |
US5057092A (en) | 1990-04-04 | 1991-10-15 | Webster Wilton W Jr | Braided catheter with low modulus warp |
US5123917A (en) | 1990-04-27 | 1992-06-23 | Lee Peter Y | Expandable intraluminal vascular graft |
CA2052981C (en) | 1990-10-09 | 1995-08-01 | Cesare Gianturco | Percutaneous stent assembly |
US5158543A (en) | 1990-10-30 | 1992-10-27 | Lazarus Harrison M | Laparoscopic surgical system and method |
CA2065634C (en) | 1991-04-11 | 1997-06-03 | Alec A. Piplani | Endovascular graft having bifurcation and apparatus and method for deploying the same |
US5628783A (en) | 1991-04-11 | 1997-05-13 | Endovascular Technologies, Inc. | Bifurcated multicapsule intraluminal grafting system and method |
US6682557B1 (en) | 1991-04-11 | 2004-01-27 | Endovascular Technologies, Inc. | Bifurcated multicapsule intraluminal grafting system and method |
US5205831A (en) | 1991-04-22 | 1993-04-27 | Burron Medical, Inc. | Compression gasket for y-connector |
US5154701A (en) | 1991-06-26 | 1992-10-13 | Adam Spence Corporation | Hemostasis valve |
US5380304A (en) | 1991-08-07 | 1995-01-10 | Cook Incorporated | Flexible, kink-resistant, introducer sheath and method of manufacture |
ES2109969T3 (en) | 1991-10-11 | 1998-02-01 | Angiomed Ag | PROCEDURE FOR THE DILATION OF A STENOSIS. |
US5338295A (en) | 1991-10-15 | 1994-08-16 | Scimed Life Systems, Inc. | Dilatation catheter with polyimide-encased stainless steel braid proximal shaft |
US5387235A (en) | 1991-10-25 | 1995-02-07 | Cook Incorporated | Expandable transluminal graft prosthesis for repair of aneurysm |
US5720776A (en) | 1991-10-25 | 1998-02-24 | Cook Incorporated | Barb and expandable transluminal graft prosthesis for repair of aneurysm |
EP0539237A1 (en) | 1991-10-25 | 1993-04-28 | Cook Incorporated | Expandable transluminal graft prosthesis for repair of aneurysm and method for implanting |
US5456713A (en) | 1991-10-25 | 1995-10-10 | Cook Incorporated | Expandable transluminal graft prosthesis for repairs of aneurysm and method for implanting |
US5290310A (en) | 1991-10-30 | 1994-03-01 | Howmedica, Inc. | Hemostatic implant introducer |
US5334164A (en) | 1992-01-03 | 1994-08-02 | United States Surgical Corporation | Variable interior dimension cannula assembly |
US5405377A (en) | 1992-02-21 | 1995-04-11 | Endotech Ltd. | Intraluminal stent |
US5201757A (en) | 1992-04-03 | 1993-04-13 | Schneider (Usa) Inc. | Medial region deployment of radially self-expanding stents |
US5533987A (en) | 1992-04-09 | 1996-07-09 | Scimed Lifesystems, Inc. | Dilatation catheter with polymide encased stainless steel braid proximal shaft |
US5540712A (en) | 1992-05-01 | 1996-07-30 | Nitinol Medical Technologies, Inc. | Stent and method and apparatus for forming and delivering the same |
US5306263A (en) | 1992-05-01 | 1994-04-26 | Jan Voda | Catheter |
US5507771A (en) | 1992-06-15 | 1996-04-16 | Cook Incorporated | Stent assembly |
US5290295A (en) | 1992-07-15 | 1994-03-01 | Querals & Fine, Inc. | Insertion tool for an intraluminal graft procedure |
US5707376A (en) | 1992-08-06 | 1998-01-13 | William Cook Europe A/S | Stent introducer and method of use |
US5342384A (en) | 1992-08-13 | 1994-08-30 | Brigham & Women's Hospital | Surgical dilator |
PT723429E (en) | 1992-09-30 | 2002-09-30 | Vladimir Feingold | INTRA-OCULAR LENS INSERTION SYSTEM |
US5417699A (en) | 1992-12-10 | 1995-05-23 | Perclose Incorporated | Device and method for the percutaneous suturing of a vascular puncture site |
US5358493A (en) | 1993-02-18 | 1994-10-25 | Scimed Life Systems, Inc. | Vascular access catheter and methods for manufacture thereof |
US5474563A (en) | 1993-03-25 | 1995-12-12 | Myler; Richard | Cardiovascular stent and retrieval apparatus |
AU689094B2 (en) | 1993-04-22 | 1998-03-26 | C.R. Bard Inc. | Non-migrating vascular prosthesis and minimally invasive placement system therefor |
US5531715A (en) | 1993-05-12 | 1996-07-02 | Target Therapeutics, Inc. | Lubricious catheters |
US5480423A (en) | 1993-05-20 | 1996-01-02 | Boston Scientific Corporation | Prosthesis delivery |
US5334168A (en) | 1993-06-11 | 1994-08-02 | Catheter Research, Inc. | Variable shape guide apparatus |
US5458615A (en) | 1993-07-06 | 1995-10-17 | Advanced Cardiovascular Systems, Inc. | Stent delivery system |
US5464449A (en) | 1993-07-08 | 1995-11-07 | Thomas J. Fogarty | Internal graft prosthesis and delivery system |
US5549565A (en) | 1993-07-13 | 1996-08-27 | Symbiosis Corporation | Reusable surgical trocar with disposable valve assembly |
CA2125258C (en) | 1993-08-05 | 1998-12-22 | Dinah B Quiachon | Multicapsule intraluminal grafting system and method |
US5954651A (en) | 1993-08-18 | 1999-09-21 | Scimed Life Systems, Inc. | Catheter having a high tensile strength braid wire constraint |
US5951495A (en) | 1993-12-22 | 1999-09-14 | Scimed Life Systems, Inc. | Catheter having an adhesive braid wire constraint and method of manufacture |
DE4428914C2 (en) | 1993-08-18 | 2000-09-28 | Scimed Life Systems Inc | Thin-walled multi-layer catheter |
US6685736B1 (en) | 1993-09-30 | 2004-02-03 | Endogad Research Pty Limited | Intraluminal graft |
WO1995008966A1 (en) | 1993-09-30 | 1995-04-06 | White Geoffrey H | Intraluminal graft |
US5639278A (en) | 1993-10-21 | 1997-06-17 | Corvita Corporation | Expandable supportive bifurcated endoluminal grafts |
US5571135A (en) | 1993-10-22 | 1996-11-05 | Scimed Life Systems Inc. | Stent delivery apparatus and method |
EP0657147B1 (en) | 1993-11-04 | 1999-08-04 | C.R. Bard, Inc. | Non-migrating vascular prosthesis |
WO1995013033A1 (en) | 1993-11-08 | 1995-05-18 | Lazarus Harrison M | Intraluminal vascular graft and method |
US5429617A (en) * | 1993-12-13 | 1995-07-04 | The Spectranetics Corporation | Radiopaque tip marker for alignment of a catheter within a body |
FR2714816B1 (en) | 1994-01-12 | 1996-02-16 | Braun Celsa Sa | Vascular prosthesis implantable in a living organism for the treatment of aneurysms. |
US6165213A (en) | 1994-02-09 | 2000-12-26 | Boston Scientific Technology, Inc. | System and method for assembling an endoluminal prosthesis |
US6051020A (en) | 1994-02-09 | 2000-04-18 | Boston Scientific Technology, Inc. | Bifurcated endoluminal prosthesis |
US5609627A (en) | 1994-02-09 | 1997-03-11 | Boston Scientific Technology, Inc. | Method for delivering a bifurcated endoluminal prosthesis |
US6039749A (en) | 1994-02-10 | 2000-03-21 | Endovascular Systems, Inc. | Method and apparatus for deploying non-circular stents and graftstent complexes |
US5507769A (en) | 1994-10-18 | 1996-04-16 | Stentco, Inc. | Method and apparatus for forming an endoluminal bifurcated graft |
US5569218A (en) | 1994-02-14 | 1996-10-29 | Scimed Life Systems, Inc. | Elastic guide catheter transition element |
US5911715A (en) | 1994-02-14 | 1999-06-15 | Scimed Life Systems, Inc. | Guide catheter having selected flexural modulus segments |
US5591194A (en) | 1994-02-18 | 1997-01-07 | C. R. Bard, Inc. | Telescoping balloon catheter and method of use |
WO1995023008A1 (en) | 1994-02-28 | 1995-08-31 | Querals & Fine, Inc. | Insertion tool for an intraluminal graft procedure having locking features |
US5415664A (en) | 1994-03-30 | 1995-05-16 | Corvita Corporation | Method and apparatus for introducing a stent or a stent-graft |
FR2718345B1 (en) | 1994-04-11 | 1997-04-04 | Braun Celsa Sa | Handle for controlled relative sliding of a sheath and a rod and apparatus for implanting a medical device, such as a filter, using such a handle. |
US5824044A (en) | 1994-05-12 | 1998-10-20 | Endovascular Technologies, Inc. | Bifurcated multicapsule intraluminal grafting system |
DE4418336A1 (en) | 1994-05-26 | 1995-11-30 | Angiomed Ag | Stent for widening and holding open receptacles |
US5683451A (en) | 1994-06-08 | 1997-11-04 | Cardiovascular Concepts, Inc. | Apparatus and methods for deployment release of intraluminal prostheses |
US5824041A (en) | 1994-06-08 | 1998-10-20 | Medtronic, Inc. | Apparatus and methods for placement and repositioning of intraluminal prostheses |
US5522881A (en) | 1994-06-28 | 1996-06-04 | Meadox Medicals, Inc. | Implantable tubular prosthesis having integral cuffs |
FR2722678B1 (en) | 1994-07-25 | 1996-12-27 | Braun Celsa Sa B | PLUG-IN MEDICAL PROSTHESIS FOR USE IN THE TREATMENT OF ANEVRISMS, DEVICE COMPRISING SUCH A PROSTHESIS |
US5575816A (en) | 1994-08-12 | 1996-11-19 | Meadox Medicals, Inc. | High strength and high density intraluminal wire stent |
US5575817A (en) | 1994-08-19 | 1996-11-19 | Martin; Eric C. | Aorto femoral bifurcation graft and method of implantation |
US5723003A (en) * | 1994-09-13 | 1998-03-03 | Ultrasonic Sensing And Monitoring Systems | Expandable graft assembly and method of use |
US5702419A (en) | 1994-09-21 | 1997-12-30 | Wake Forest University | Expandable, intraluminal stents |
US5545210A (en) * | 1994-09-22 | 1996-08-13 | Advanced Coronary Technology, Inc. | Method of implanting a permanent shape memory alloy stent |
US5522882A (en) | 1994-10-21 | 1996-06-04 | Impra, Inc. | Method and apparatus for balloon expandable stent-graft delivery |
AU3783195A (en) | 1994-11-15 | 1996-05-23 | Advanced Cardiovascular Systems Inc. | Intraluminal stent for attaching a graft |
NL9500094A (en) | 1995-01-19 | 1996-09-02 | Industrial Res Bv | Y-shaped stent and method of deployment. |
US5755770A (en) | 1995-01-31 | 1998-05-26 | Boston Scientific Corporatiion | Endovascular aortic graft |
US5662675A (en) | 1995-02-24 | 1997-09-02 | Intervascular, Inc. | Delivery catheter assembly |
US5683449A (en) | 1995-02-24 | 1997-11-04 | Marcade; Jean Paul | Modular bifurcated intraluminal grafts and methods for delivering and assembling same |
US6053943A (en) | 1995-12-08 | 2000-04-25 | Impra, Inc. | Endoluminal graft with integral structural support and method for making same |
EP0813397A4 (en) | 1995-03-10 | 1999-10-06 | Cardiovascular Concepts Inc | Tubular endoluminar prosthesis having oblique ends |
US6306144B1 (en) | 1996-11-01 | 2001-10-23 | Scimed Life Systems, Inc. | Selective coating of a balloon catheter with lubricious material for stent deployment |
US5571168A (en) | 1995-04-05 | 1996-11-05 | Scimed Lifesystems Inc | Pull back stent delivery system |
US5658263A (en) | 1995-05-18 | 1997-08-19 | Cordis Corporation | Multisegmented guiding catheter for use in medical catheter systems |
US5534007A (en) | 1995-05-18 | 1996-07-09 | Scimed Life Systems, Inc. | Stent deployment catheter with collapsible sheath |
WO1996036297A1 (en) | 1995-05-19 | 1996-11-21 | Kanji Inoue | Transplantation instrument, method of bending same and method of transplanting same |
US5618270A (en) | 1995-05-26 | 1997-04-08 | Orejola; Wilmo C. | Transthoracic aortic sleeve |
CA2222579A1 (en) | 1995-06-01 | 1996-12-05 | Scimed Life Systems, Inc. | Flow assisted catheter |
US5700269A (en) | 1995-06-06 | 1997-12-23 | Corvita Corporation | Endoluminal prosthesis deployment device for use with prostheses of variable length and having retraction ability |
US6814748B1 (en) | 1995-06-07 | 2004-11-09 | Endovascular Technologies, Inc. | Intraluminal grafting system |
US5788707A (en) | 1995-06-07 | 1998-08-04 | Scimed Life Systems, Inc. | Pull back sleeve system with compression resistant inner shaft |
US5628754A (en) | 1995-08-01 | 1997-05-13 | Medtronic, Inc. | Stent delivery guide catheter |
FR2737404B1 (en) | 1995-08-03 | 1997-09-19 | Braun Celsa Sa | PROSTHESIS IMPLANTABLE IN A HUMAN OR ANIMAL CONDUCT, SUCH AS A WALL Expander, OR ANEURISM PROSTHESIS |
US6814747B2 (en) | 1995-09-08 | 2004-11-09 | Anthony Walter Anson | Surgical graft/stent system |
US5807405A (en) | 1995-09-11 | 1998-09-15 | St. Jude Medical, Inc. | Apparatus for attachment of heart valve holder to heart valve prosthesis |
AU6862596A (en) | 1995-09-18 | 1997-04-09 | W.L. Gore & Associates, Inc. | A delivery system for intraluminal vascular grafts |
US5824036A (en) | 1995-09-29 | 1998-10-20 | Datascope Corp | Stent for intraluminal grafts and device and methods for delivering and assembling same |
US6193745B1 (en) | 1995-10-03 | 2001-02-27 | Medtronic, Inc. | Modular intraluminal prosteheses construction and methods |
US5824037A (en) | 1995-10-03 | 1998-10-20 | Medtronic, Inc. | Modular intraluminal prostheses construction and methods |
US5591195A (en) | 1995-10-30 | 1997-01-07 | Taheri; Syde | Apparatus and method for engrafting a blood vessel |
US6287315B1 (en) | 1995-10-30 | 2001-09-11 | World Medical Manufacturing Corporation | Apparatus for delivering an endoluminal prosthesis |
US6045557A (en) | 1995-11-10 | 2000-04-04 | Baxter International Inc. | Delivery catheter and method for positioning an intraluminal graft |
US5607442A (en) | 1995-11-13 | 1997-03-04 | Isostent, Inc. | Stent with improved radiopacity and appearance characteristics |
EP0775470B1 (en) | 1995-11-14 | 1999-03-24 | Schneider (Europe) GmbH | Stent delivery device |
US6576009B2 (en) | 1995-12-01 | 2003-06-10 | Medtronic Ave, Inc. | Bifurcated intraluminal prostheses construction and methods |
US5824040A (en) | 1995-12-01 | 1998-10-20 | Medtronic, Inc. | Endoluminal prostheses and therapies for highly variable body lumens |
US6042605A (en) | 1995-12-14 | 2000-03-28 | Gore Enterprose Holdings, Inc. | Kink resistant stent-graft |
FR2742994B1 (en) | 1995-12-28 | 1998-04-03 | Sgro Jean-Claude | INTRACORPOREAL LIGHT SURGICAL TREATMENT ASSEMBLY |
US5843158A (en) | 1996-01-05 | 1998-12-01 | Medtronic, Inc. | Limited expansion endoluminal prostheses and methods for their use |
US6878161B2 (en) | 1996-01-05 | 2005-04-12 | Medtronic Vascular, Inc. | Stent graft loading and deployment device and method |
US5749921A (en) | 1996-02-20 | 1998-05-12 | Medtronic, Inc. | Apparatus and methods for compression of endoluminal prostheses |
US6039759A (en) | 1996-02-20 | 2000-03-21 | Baxter International Inc. | Mechanical prosthetic valve with coupled leaflets |
CA2192520A1 (en) * | 1996-03-05 | 1997-09-05 | Ian M. Penn | Expandable stent and method for delivery of same |
WO1997033532A2 (en) | 1996-03-13 | 1997-09-18 | Medtronic, Inc. | Endoluminal prostheses and therapies for multiple-branch body lumen systems |
US5843160A (en) | 1996-04-01 | 1998-12-01 | Rhodes; Valentine J. | Prostheses for aneurysmal and/or occlusive disease at a bifurcation in a vessel, duct, or lumen |
US5824042A (en) | 1996-04-05 | 1998-10-20 | Medtronic, Inc. | Endoluminal prostheses having position indicating markers |
JP4636634B2 (en) | 1996-04-26 | 2011-02-23 | ボストン サイエンティフィック サイムド,インコーポレイテッド | Intravascular stent |
US5782811A (en) | 1996-05-30 | 1998-07-21 | Target Therapeutics, Inc. | Kink-resistant braided catheter with distal side holes |
US5899892A (en) | 1996-05-31 | 1999-05-04 | Scimed Life Systems, Inc. | Catheter having distal fiber braid |
US7238197B2 (en) | 2000-05-30 | 2007-07-03 | Devax, Inc. | Endoprosthesis deployment system for treating vascular bifurcations |
US5741234A (en) | 1996-07-16 | 1998-04-21 | Aboul-Hosn; Walid Nagib | Anatomical cavity access sealing condit |
US5800517A (en) | 1996-08-19 | 1998-09-01 | Scimed Life Systems, Inc. | Stent delivery system with storage sleeve |
CA2263492C (en) | 1996-08-23 | 2006-10-17 | Scimed Life Systems, Inc. | Stent delivery system having stent securement apparatus |
US5944726A (en) | 1996-08-23 | 1999-08-31 | Scimed Life Systems, Inc. | Stent delivery system having stent securement means |
US5910101A (en) | 1996-08-29 | 1999-06-08 | Advanced Cardiovascular Systems, Inc. | Device for loading and centering a vascular radiation therapy source |
US5968068A (en) | 1996-09-12 | 1999-10-19 | Baxter International Inc. | Endovascular delivery system |
US6520951B1 (en) | 1996-09-13 | 2003-02-18 | Scimed Life Systems, Inc. | Rapid exchange catheter with detachable hood |
US6432127B1 (en) * | 1996-10-11 | 2002-08-13 | Transvascular, Inc. | Devices for forming and/or maintaining connections between adjacent anatomical conduits |
US5755778A (en) | 1996-10-16 | 1998-05-26 | Nitinol Medical Technologies, Inc. | Anastomosis device |
US6692483B2 (en) | 1996-11-04 | 2004-02-17 | Advanced Stent Technologies, Inc. | Catheter with attached flexible side sheath |
US6682536B2 (en) | 2000-03-22 | 2004-01-27 | Advanced Stent Technologies, Inc. | Guidewire introducer sheath |
US6395017B1 (en) | 1996-11-15 | 2002-05-28 | C. R. Bard, Inc. | Endoprosthesis delivery catheter with sequential stage control |
US5860998A (en) * | 1996-11-25 | 1999-01-19 | C. R. Bard, Inc. | Deployment device for tubular expandable prosthesis |
US6827710B1 (en) | 1996-11-26 | 2004-12-07 | Edwards Lifesciences Corporation | Multiple lumen access device |
US5776142A (en) | 1996-12-19 | 1998-07-07 | Medtronic, Inc. | Controllable stent delivery system and method |
US6551350B1 (en) | 1996-12-23 | 2003-04-22 | Gore Enterprise Holdings, Inc. | Kink resistant bifurcated prosthesis |
BE1010858A4 (en) | 1997-01-16 | 1999-02-02 | Medicorp R & D Benelux Sa | Luminal endoprosthesis FOR BRANCHING. |
US5735859A (en) | 1997-02-14 | 1998-04-07 | Cathco, Inc. | Distally attachable and releasable sheath for a stent delivery system |
US6152944A (en) | 1997-03-05 | 2000-11-28 | Scimed Life Systems, Inc. | Catheter with removable balloon protector and stent delivery system with removable stent protector |
US5893868A (en) | 1997-03-05 | 1999-04-13 | Scimed Life Systems, Inc. | Catheter with removable balloon protector and stent delivery system with removable stent protector |
US6059812A (en) | 1997-03-21 | 2000-05-09 | Schneider (Usa) Inc. | Self-expanding medical device for centering radioactive treatment sources in body vessels |
US5824055A (en) | 1997-03-25 | 1998-10-20 | Endotex Interventional Systems, Inc. | Stent graft delivery system and methods of use |
US5792144A (en) | 1997-03-31 | 1998-08-11 | Cathco, Inc. | Stent delivery catheter system |
US5957949A (en) | 1997-05-01 | 1999-09-28 | World Medical Manufacturing Corp. | Percutaneous placement valve stent |
AUPO700897A0 (en) | 1997-05-26 | 1997-06-19 | William A Cook Australia Pty Ltd | A method and means of deploying a graft |
AU738244B2 (en) | 1997-05-29 | 2001-09-13 | Edwards Lifesciences Corporation | Shape-adjustable surgical implement handle |
US6168616B1 (en) | 1997-06-02 | 2001-01-02 | Global Vascular Concepts | Manually expandable stent |
US6004328A (en) | 1997-06-19 | 1999-12-21 | Solar; Ronald J. | Radially expandable intraluminal stent and delivery catheter therefore and method of using the same |
US5904713A (en) | 1997-07-14 | 1999-05-18 | Datascope Investment Corp. | Invertible bifurcated stent/graft and method of deployment |
US5906619A (en) | 1997-07-24 | 1999-05-25 | Medtronic, Inc. | Disposable delivery device for endoluminal prostheses |
GB9716497D0 (en) | 1997-08-05 | 1997-10-08 | Bridport Gundry Plc | Occlusion device |
US5984955A (en) | 1997-09-11 | 1999-11-16 | Wisselink; Willem | System and method for endoluminal grafting of bifurcated or branched vessels |
US5891114A (en) | 1997-09-30 | 1999-04-06 | Target Therapeutics, Inc. | Soft-tip high performance braided catheter |
US5984956A (en) | 1997-10-06 | 1999-11-16 | Heartstent Corporation | Transmyocardial implant |
US5891110A (en) | 1997-10-15 | 1999-04-06 | Scimed Life Systems, Inc. | Over-the-wire catheter with improved trackability |
US6224625B1 (en) | 1997-10-27 | 2001-05-01 | Iowa-India Investments Company Limited | Low profile highly expandable stent |
US6120480A (en) | 1997-10-28 | 2000-09-19 | Medtronic Ave, Inc. | Catheter introducer |
US6416490B1 (en) * | 1997-11-04 | 2002-07-09 | Scimed Life Systems, Inc. | PMR device and method |
DE19753123B4 (en) | 1997-11-29 | 2006-11-09 | B. Braun Melsungen Ag | stent |
AUPP083597A0 (en) | 1997-12-10 | 1998-01-08 | William A Cook Australia Pty Ltd | Endoluminal aortic stents |
US6248116B1 (en) | 1997-12-16 | 2001-06-19 | B. Braun Celsa | Medical treatment of a diseased anatomical duct |
US5910144A (en) | 1998-01-09 | 1999-06-08 | Endovascular Technologies, Inc. | Prosthesis gripping system and method |
GB2349827B (en) * | 1998-01-26 | 2003-03-19 | Anson Medical Ltd | Reinforced graft |
US7226433B2 (en) | 1998-02-06 | 2007-06-05 | Possis Medical, Inc. | Thrombectomy catheter device having a self-sealing hemostasis valve |
US6651670B2 (en) | 1998-02-13 | 2003-11-25 | Ventrica, Inc. | Delivering a conduit into a heart wall to place a coronary vessel in communication with a heart chamber and removing tissue from the vessel or heart wall to facilitate such communication |
US6338709B1 (en) | 1998-02-19 | 2002-01-15 | Medtronic Percusurge, Inc. | Intravascular radiation therapy device and method of use |
US6280467B1 (en) | 1998-02-26 | 2001-08-28 | World Medical Manufacturing Corporation | Delivery system for deployment and endovascular assembly of a multi-stage stented graft |
US6425898B1 (en) | 1998-03-13 | 2002-07-30 | Cordis Corporation | Delivery apparatus for a self-expanding stent |
US6019778A (en) | 1998-03-13 | 2000-02-01 | Cordis Corporation | Delivery apparatus for a self-expanding stent |
US6129756A (en) | 1998-03-16 | 2000-10-10 | Teramed, Inc. | Biluminal endovascular graft system |
US6224609B1 (en) | 1998-03-16 | 2001-05-01 | Teramed Inc. | Bifurcated prosthetic graft |
US6524336B1 (en) | 1998-04-09 | 2003-02-25 | Cook Incorporated | Endovascular graft |
US6099559A (en) | 1998-05-28 | 2000-08-08 | Medtronic Ave, Inc. | Endoluminal support assembly with capped ends |
AU754156B2 (en) | 1998-06-02 | 2002-11-07 | Cook Incorporated | Multiple-sided intraluminal medical device |
US6224627B1 (en) | 1998-06-15 | 2001-05-01 | Gore Enterprise Holdings, Inc. | Remotely removable covering and support |
US6171334B1 (en) | 1998-06-17 | 2001-01-09 | Advanced Cardiovascular Systems, Inc. | Expandable stent and method of use |
US6004310A (en) | 1998-06-17 | 1999-12-21 | Target Therapeutics, Inc. | Multilumen catheter shaft with reinforcement |
FR2779939B1 (en) | 1998-06-17 | 2000-09-15 | Perouse Implant Lab | DEVICE FOR TREATING A BLOOD VESSEL |
US6285903B1 (en) * | 1998-06-30 | 2001-09-04 | Eclipse Surgical Technologies, Inc. | Intracorporeal device with radiopaque marker |
US20020007193A1 (en) | 1998-07-01 | 2002-01-17 | Howard Tanner | Method and apparatus for the surgical repair of aneurysms |
US6245052B1 (en) | 1998-07-08 | 2001-06-12 | Innerdyne, Inc. | Methods, systems, and kits for implanting articles |
US6764503B1 (en) * | 1998-07-10 | 2004-07-20 | Shin Ishimaru | Stent (or stent graft) locating device |
US6099548A (en) | 1998-07-28 | 2000-08-08 | Taheri; Syde A. | Apparatus and method for deploying an aortic arch graft |
US5954694A (en) | 1998-08-07 | 1999-09-21 | Embol-X, Inc. | Nested tubing sections and methods for making same |
US6168623B1 (en) | 1998-08-31 | 2001-01-02 | Cardiothoracic Systems, Inc. | Deformable conduits and methods for shunting bodily fluid during surgery |
US6755856B2 (en) | 1998-09-05 | 2004-06-29 | Abbott Laboratories Vascular Enterprises Limited | Methods and apparatus for stenting comprising enhanced embolic protection, coupled with improved protection against restenosis and thrombus formation |
US6093173A (en) | 1998-09-09 | 2000-07-25 | Embol-X, Inc. | Introducer/dilator with balloon protection and methods of use |
US6464684B1 (en) | 1998-09-09 | 2002-10-15 | Scimed Life Systems, Inc. | Catheter having regions of differing braid densities and methods of manufacture therefor |
US6203550B1 (en) | 1998-09-30 | 2001-03-20 | Medtronic, Inc. | Disposable delivery device for endoluminal prostheses |
US6368345B1 (en) | 1998-09-30 | 2002-04-09 | Edwards Lifesciences Corporation | Methods and apparatus for intraluminal placement of a bifurcated intraluminal garafat |
US6849088B2 (en) | 1998-09-30 | 2005-02-01 | Edwards Lifesciences Corporation | Aorto uni-iliac graft |
US6071307A (en) | 1998-09-30 | 2000-06-06 | Baxter International Inc. | Endoluminal grafts having continuously curvilinear wireforms |
US6248112B1 (en) | 1998-09-30 | 2001-06-19 | C. R. Bard, Inc. | Implant delivery system |
US6273909B1 (en) | 1998-10-05 | 2001-08-14 | Teramed Inc. | Endovascular graft system |
US6051014A (en) | 1998-10-13 | 2000-04-18 | Embol-X, Inc. | Percutaneous filtration catheter for valve repair surgery and methods of use |
US6193705B1 (en) | 1998-10-28 | 2001-02-27 | Scimed Life Systems, Inc. | Flow assisted catheter |
US6508252B1 (en) | 1998-11-06 | 2003-01-21 | St. Jude Medical Atg, Inc. | Medical grafting methods and apparatus |
US6322585B1 (en) | 1998-11-16 | 2001-11-27 | Endotex Interventional Systems, Inc. | Coiled-sheet stent-graft with slidable exo-skeleton |
WO2000030562A1 (en) * | 1998-11-25 | 2000-06-02 | Endovascular Technologies, Inc. | Aortoiliac grafting system and method |
US6660030B2 (en) | 1998-12-11 | 2003-12-09 | Endologix, Inc. | Bifurcation graft deployment catheter |
US6733523B2 (en) | 1998-12-11 | 2004-05-11 | Endologix, Inc. | Implantable vascular graft |
US6254609B1 (en) | 1999-01-11 | 2001-07-03 | Scimed Life Systems, Inc. | Self-expanding stent delivery system with two sheaths |
US6350277B1 (en) | 1999-01-15 | 2002-02-26 | Scimed Life Systems, Inc. | Stents with temporary retaining bands |
US7025773B2 (en) | 1999-01-15 | 2006-04-11 | Medtronic, Inc. | Methods and devices for placing a conduit in fluid communication with a target vessel |
US6171295B1 (en) | 1999-01-20 | 2001-01-09 | Scimed Life Systems, Inc. | Intravascular catheter with composite reinforcement |
US6517571B1 (en) | 1999-01-22 | 2003-02-11 | Gore Enterprise Holdings, Inc. | Vascular graft with improved flow surfaces |
US6592526B1 (en) | 1999-01-25 | 2003-07-15 | Jay Alan Lenker | Resolution ultrasound devices for imaging and treatment of body lumens |
US6200339B1 (en) | 1999-02-23 | 2001-03-13 | Datascope Investment Corp. | Endovascular split-tube bifurcated graft prosthesis and an implantation method for such a prosthesis |
JP2002537065A (en) | 1999-02-26 | 2002-11-05 | ヴァスキュラー・アーキテクツ・インコーポレイテッド | Catheter assembly with endoluminal prosthesis and method of placement thereof |
US6248122B1 (en) | 1999-02-26 | 2001-06-19 | Vascular Architects, Inc. | Catheter with controlled release endoluminal prosthesis |
US6183505B1 (en) | 1999-03-11 | 2001-02-06 | Medtronic Ave, Inc. | Method of stent retention to a delivery catheter balloon-braided retainers |
DE19912372C1 (en) * | 1999-03-19 | 2000-11-09 | Case Harvesting Sys Gmbh | Device for measuring the grain fraction in a return of a combine harvester |
US6443980B1 (en) | 1999-03-22 | 2002-09-03 | Scimed Life Systems, Inc. | End sleeve coating for stent delivery |
US20010000801A1 (en) | 1999-03-22 | 2001-05-03 | Miller Paul J. | Hydrophilic sleeve |
US6478818B1 (en) | 1999-04-01 | 2002-11-12 | Syde A. Taheri | Arterial bypass procedure |
US6319275B1 (en) | 1999-04-07 | 2001-11-20 | Medtronic Ave, Inc. | Endolumenal prosthesis delivery assembly and method of use |
US6183512B1 (en) | 1999-04-16 | 2001-02-06 | Edwards Lifesciences Corporation | Flexible annuloplasty system |
US6287335B1 (en) | 1999-04-26 | 2001-09-11 | William J. Drasler | Intravascular folded tubular endoprosthesis |
AU4606400A (en) | 1999-05-07 | 2000-11-21 | Salviac Limited | Improved filter element for embolic protection device |
US6726712B1 (en) | 1999-05-14 | 2004-04-27 | Boston Scientific Scimed | Prosthesis deployment device with translucent distal end |
US6375676B1 (en) | 1999-05-17 | 2002-04-23 | Advanced Cardiovascular Systems, Inc. | Self-expanding stent with enhanced delivery precision and stent delivery system |
US6858034B1 (en) | 1999-05-20 | 2005-02-22 | Scimed Life Systems, Inc. | Stent delivery system for prevention of kinking, and method of loading and using same |
US6270521B1 (en) | 1999-05-21 | 2001-08-07 | Cordis Corporation | Stent delivery catheter system for primary stenting |
US6398802B1 (en) | 1999-06-21 | 2002-06-04 | Scimed Life Systems, Inc. | Low profile delivery system for stent and graft deployment |
WO2001006952A1 (en) | 1999-07-16 | 2001-02-01 | Med Institute, Inc. | Stent adapted for tangle-free deployment |
US6213976B1 (en) | 1999-07-22 | 2001-04-10 | Advanced Research And Technology Institute, Inc. | Brachytherapy guide catheter |
US6706033B1 (en) | 1999-08-02 | 2004-03-16 | Edwards Lifesciences Corporation | Modular access port for device delivery |
DE19936980C1 (en) | 1999-08-05 | 2001-04-26 | Aesculap Ag & Co Kg | Insertion catheter for vascular prostheses |
US6102931A (en) | 1999-08-09 | 2000-08-15 | Embol-X, Inc. | Intravascular device for venting an inflatable chamber |
US6221079B1 (en) | 1999-08-31 | 2001-04-24 | Cardiac Assist Technologies, Inc. | Method and apparatus for vessel repair in a patient |
US6458151B1 (en) | 1999-09-10 | 2002-10-01 | Frank S. Saltiel | Ostial stent positioning device and method |
US6183481B1 (en) | 1999-09-22 | 2001-02-06 | Endomed Inc. | Delivery system for self-expanding stents and grafts |
DE60042746D1 (en) * | 1999-09-23 | 2009-09-24 | Endogad Res Pty Ltd | INTRALUMINAL DOUBLE LAYER TRANSPLANT |
US6344052B1 (en) | 1999-09-27 | 2002-02-05 | World Medical Manufacturing Corporation | Tubular graft with monofilament fibers |
US6458867B1 (en) | 1999-09-28 | 2002-10-01 | Scimed Life Systems, Inc. | Hydrophilic lubricant coatings for medical devices |
US6533806B1 (en) | 1999-10-01 | 2003-03-18 | Scimed Life Systems, Inc. | Balloon yielded delivery system and endovascular graft design for easy deployment |
US6514282B1 (en) | 1999-10-04 | 2003-02-04 | Kanji Inoue | Method of folding transplanting instrument and transplanting instrument |
US6302907B1 (en) | 1999-10-05 | 2001-10-16 | Scimed Life Systems, Inc. | Flexible endoluminal stent and process of manufacture |
DE19951607A1 (en) * | 1999-10-26 | 2001-05-10 | Biotronik Mess & Therapieg | Stent with a closed structure |
US6264671B1 (en) | 1999-11-15 | 2001-07-24 | Advanced Cardiovascular Systems, Inc. | Stent delivery catheter and method of use |
JP4185226B2 (en) | 1999-11-19 | 2008-11-26 | テルモ株式会社 | Medical device whose surface exhibits lubricity when wet and method for producing the same |
US6280466B1 (en) | 1999-12-03 | 2001-08-28 | Teramed Inc. | Endovascular graft system |
US6443979B1 (en) | 1999-12-20 | 2002-09-03 | Advanced Cardiovascular Systems, Inc. | Expandable stent delivery sheath and method of use |
US6450988B1 (en) | 1999-12-29 | 2002-09-17 | Advanced Cardiovascular Systems, Inc. | Centering catheter with improved perfusion |
US6533752B1 (en) | 2000-01-05 | 2003-03-18 | Thomas C Waram | Variable shape guide apparatus |
US6312458B1 (en) | 2000-01-19 | 2001-11-06 | Scimed Life Systems, Inc. | Tubular structure/stent/stent securement member |
US6652571B1 (en) | 2000-01-31 | 2003-11-25 | Scimed Life Systems, Inc. | Braided, branched, implantable device and processes for manufacture thereof |
US6402781B1 (en) | 2000-01-31 | 2002-06-11 | Mitralife | Percutaneous mitral annuloplasty and cardiac reinforcement |
AU2001233316B2 (en) | 2000-02-04 | 2005-04-28 | Cook Medical Technologies Llc | Stent introducer apparatus |
US6344044B1 (en) | 2000-02-11 | 2002-02-05 | Edwards Lifesciences Corp. | Apparatus and methods for delivery of intraluminal prosthesis |
US6942688B2 (en) | 2000-02-29 | 2005-09-13 | Cordis Corporation | Stent delivery system having delivery catheter member with a clear transition zone |
US6319278B1 (en) * | 2000-03-03 | 2001-11-20 | Stephen F. Quinn | Low profile device for the treatment of vascular abnormalities |
KR20020082872A (en) | 2000-03-14 | 2002-10-31 | 쿡 인코포레이티드 | Edovascular stent graft |
US6533753B1 (en) | 2000-04-07 | 2003-03-18 | Philip Haarstad | Apparatus and method for the treatment of an occluded lumen |
US6517573B1 (en) | 2000-04-11 | 2003-02-11 | Endovascular Technologies, Inc. | Hook for attaching to a corporeal lumen and method of manufacturing |
US7722663B1 (en) | 2000-04-24 | 2010-05-25 | Scimed Life Systems, Inc. | Anatomically correct endoluminal prostheses |
US6942691B1 (en) | 2000-04-27 | 2005-09-13 | Timothy A. M. Chuter | Modular bifurcated graft for endovascular aneurysm repair |
US7226474B2 (en) | 2000-05-01 | 2007-06-05 | Endovascular Technologies, Inc. | Modular graft component junctions |
US6454796B1 (en) | 2000-05-05 | 2002-09-24 | Endovascular Technologies, Inc. | Vascular graft |
US20030139803A1 (en) | 2000-05-30 | 2003-07-24 | Jacques Sequin | Method of stenting a vessel with stent lumenal diameter increasing distally |
JP2002035135A (en) | 2000-07-31 | 2002-02-05 | Manii Kk | Stent and method for manufacturing stent |
US6773454B2 (en) | 2000-08-02 | 2004-08-10 | Michael H. Wholey | Tapered endovascular stent graft and method of treating abdominal aortic aneurysms and distal iliac aneurysms |
US20020016597A1 (en) | 2000-08-02 | 2002-02-07 | Dwyer Clifford J. | Delivery apparatus for a self-expanding stent |
AU2001286731A1 (en) | 2000-08-25 | 2002-03-04 | Kensey Nash Corporation | Covered stents, systems for deploying covered stents |
DE10044043A1 (en) | 2000-08-30 | 2002-03-14 | Biotronik Mess & Therapieg | Repositionable stent |
US6945989B1 (en) | 2000-09-18 | 2005-09-20 | Endotex Interventional Systems, Inc. | Apparatus for delivering endoluminal prostheses and methods of making and using them |
WO2002027085A2 (en) | 2000-09-28 | 2002-04-04 | Vascutek Limited | Needleloom, weaving method, and textile articles formed thereby |
CN2451136Y (en) | 2000-09-30 | 2001-10-03 | 张旋 | Intravascular dilator |
US6589273B1 (en) | 2000-10-02 | 2003-07-08 | Impra, Inc. | Apparatus and method for relining a blood vessel |
DE60115821T2 (en) | 2000-10-13 | 2006-08-31 | Medtronic AVE, Inc., Santa Rosa | Hydraulic stent delivery system |
AU2002225848A1 (en) | 2000-10-31 | 2002-05-15 | Prodesco, Inc. | Leak and tear resistant grafts |
US7803149B2 (en) | 2002-07-12 | 2010-09-28 | Cook Incorporated | Coated medical device |
US6582460B1 (en) | 2000-11-20 | 2003-06-24 | Advanced Cardiovascular Systems, Inc. | System and method for accurately deploying a stent |
US6540719B2 (en) | 2000-12-08 | 2003-04-01 | Advanced Cardiovascular Systems, Inc. | Catheter with rotatable balloon |
US6645242B1 (en) | 2000-12-11 | 2003-11-11 | Stephen F. Quinn | Bifurcated side-access intravascular stent graft |
US6562022B2 (en) | 2000-12-13 | 2003-05-13 | Advanced Cardiovascular Systems, Inc. | Catheter with enhanced reinforcement |
US6692458B2 (en) | 2000-12-19 | 2004-02-17 | Edwards Lifesciences Corporation | Intra-pericardial drug delivery device with multiple balloons and method for angiogenesis |
US6616626B2 (en) | 2000-12-21 | 2003-09-09 | Scimed Life Systems, Inc. | Infusion devices and method |
US6500130B2 (en) * | 2000-12-21 | 2002-12-31 | Scimed Life Systems, Inc. | Steerable guidewire |
US6540777B2 (en) | 2001-02-15 | 2003-04-01 | Scimed Life Systems, Inc. | Locking stent |
US6863688B2 (en) * | 2001-02-15 | 2005-03-08 | Spinecore, Inc. | Intervertebral spacer device utilizing a spirally slotted belleville washer having radially spaced concentric grooves |
US6918925B2 (en) | 2001-03-23 | 2005-07-19 | Hassan Tehrani | Branched aortic arch stent graft and method of deployment |
DE60104647T2 (en) | 2001-03-27 | 2005-08-11 | William Cook Europe Aps | Vascular graft for the aorta |
DK1372534T3 (en) | 2001-03-28 | 2007-03-26 | Cook Inc | Set of sections for a modular stent implant device |
US6821291B2 (en) | 2001-06-01 | 2004-11-23 | Ams Research Corporation | Retrievable stent and method of use thereof |
US6994722B2 (en) | 2001-07-03 | 2006-02-07 | Scimed Life Systems, Inc. | Implant having improved fixation to a body lumen and method for implanting the same |
EA005172B1 (en) | 2001-07-06 | 2004-12-30 | Ангиомед Гмбх Унд Ко.Медицинтехник Кг | Delivery system having a rapid pusher assembly for self-expanding stent, and stent exchange configuration |
US7011647B2 (en) | 2001-07-13 | 2006-03-14 | Scimed Life Systems, Inc. | Introducer sheath |
EP1414374B1 (en) * | 2001-08-08 | 2005-10-26 | Arno Bücker | Metallic endoprosthesis compatible with magnetic resonance |
US6866669B2 (en) | 2001-10-12 | 2005-03-15 | Cordis Corporation | Locking handle deployment mechanism for medical device and method |
US6939352B2 (en) | 2001-10-12 | 2005-09-06 | Cordis Corporation | Handle deployment mechanism for medical device and method |
US20030083734A1 (en) | 2001-10-25 | 2003-05-01 | Curative Ag | Stent |
AUPR847301A0 (en) | 2001-10-26 | 2001-11-15 | Cook Incorporated | Endoluminal prostheses for curved lumens |
US8231639B2 (en) | 2001-11-28 | 2012-07-31 | Aptus Endosystems, Inc. | Systems and methods for attaching a prosthesis within a body lumen or hollow organ |
US7147657B2 (en) | 2003-10-23 | 2006-12-12 | Aptus Endosystems, Inc. | Prosthesis delivery systems and methods |
US6902575B2 (en) | 2001-12-18 | 2005-06-07 | Linvatec Biomaterials, Inc. | Stent delivery apparatus and method |
US7014653B2 (en) | 2001-12-20 | 2006-03-21 | Cleveland Clinic Foundation | Furcated endovascular prosthesis |
US6641606B2 (en) | 2001-12-20 | 2003-11-04 | Cleveland Clinic Foundation | Delivery system and method for deploying an endovascular prosthesis |
US6682537B2 (en) | 2001-12-20 | 2004-01-27 | The Cleveland Clinic Foundation | Apparatus and method for capturing a wire in a blood vessel |
WO2003053288A1 (en) | 2001-12-20 | 2003-07-03 | Trivascular, Inc. | Advanced endovascular graft |
US20030135269A1 (en) | 2002-01-16 | 2003-07-17 | Swanstrom Lee L. | Laparoscopic-assisted endovascular/endoluminal graft placement |
US6939368B2 (en) | 2002-01-17 | 2005-09-06 | Scimed Life Systems, Inc. | Delivery system for self expanding stents for use in bifurcated vessels |
GB0203177D0 (en) | 2002-02-11 | 2002-03-27 | Anson Medical Ltd | An improved control mechanism for medical catheters |
US7169170B2 (en) | 2002-02-22 | 2007-01-30 | Cordis Corporation | Self-expanding stent delivery system |
US7708771B2 (en) | 2002-02-26 | 2010-05-04 | Endovascular Technologies, Inc. | Endovascular graft device and methods for attaching components thereof |
WO2003071929A2 (en) | 2002-02-26 | 2003-09-04 | Endovascular Technologies, Inc. | Endovascular grafting device |
US6989024B2 (en) | 2002-02-28 | 2006-01-24 | Counter Clockwise, Inc. | Guidewire loaded stent for delivery through a catheter |
DE60319353T2 (en) | 2002-03-25 | 2009-03-19 | William Cook Europe Aps | BRANCHED TANK |
US7052511B2 (en) | 2002-04-04 | 2006-05-30 | Scimed Life Systems, Inc. | Delivery system and method for deployment of foreshortening endoluminal devices |
US7105016B2 (en) | 2002-04-23 | 2006-09-12 | Medtronic Vascular, Inc. | Integrated mechanical handle with quick slide mechanism |
US6911039B2 (en) | 2002-04-23 | 2005-06-28 | Medtronic Vascular, Inc. | Integrated mechanical handle with quick slide mechanism |
US6830575B2 (en) | 2002-05-08 | 2004-12-14 | Scimed Life Systems, Inc. | Method and device for providing full protection to a stent |
US7351256B2 (en) | 2002-05-10 | 2008-04-01 | Cordis Corporation | Frame based unidirectional flow prosthetic implant |
WO2003094789A1 (en) | 2002-05-13 | 2003-11-20 | Salviac Limited | Retrieval catheter for an embolic filter |
US7887575B2 (en) | 2002-05-22 | 2011-02-15 | Boston Scientific Scimed, Inc. | Stent with segmented graft |
CA2486363A1 (en) | 2002-05-28 | 2003-12-04 | The Cleveland Clinic Foundation | Minimally invasive treatment system for aortic aneurysms |
CA2486390C (en) | 2002-05-29 | 2011-01-04 | William A. Cook Australia Pty. Ltd. | Trigger wire system for a prosthesis deployment device |
US7264632B2 (en) | 2002-06-07 | 2007-09-04 | Medtronic Vascular, Inc. | Controlled deployment delivery system |
US20030236565A1 (en) | 2002-06-21 | 2003-12-25 | Dimatteo Kristian | Implantable prosthesis |
US6932829B2 (en) | 2002-06-24 | 2005-08-23 | Cordis Corporation | Centering catheter |
CA2487131C (en) | 2002-06-28 | 2011-04-26 | Cook Incorporated | Thoracic stent graft introducer |
US6761731B2 (en) | 2002-06-28 | 2004-07-13 | Cordis Corporation | Balloon-stent interaction to help reduce foreshortening |
US7001420B2 (en) | 2002-07-01 | 2006-02-21 | Advanced Cardiovascular Systems, Inc. | Coil reinforced multilayered inner tubular member for a balloon catheter |
US7115134B2 (en) | 2002-07-22 | 2006-10-03 | Chambers Technology, Llc. | Catheter with flexible tip and shape retention |
US7070582B2 (en) | 2002-08-09 | 2006-07-04 | Boston Scientific Scimed, Inc. | Injection devices that provide reduced outflow of therapeutic agents and methods of delivering therapeutic agents |
US6863668B2 (en) | 2002-08-16 | 2005-03-08 | Edwards Lifesciences Corporation | Articulation mechanism for medical devices |
ATE417570T1 (en) | 2002-08-23 | 2009-01-15 | Cook William A Australia | COMPOSITE PROSTHESIS |
WO2004017868A1 (en) | 2002-08-23 | 2004-03-04 | William A. Cook Australia Pty. Ltd. | Asymmetric stent graft attachment |
AU2002951147A0 (en) | 2002-09-02 | 2002-09-19 | Cook Incorporated | Branch grafting device and method |
US7838119B2 (en) | 2002-09-19 | 2010-11-23 | Medtronic, Inc. | Medical assembly suitable for long-term implantation and method for fabricating the same |
US6871085B2 (en) | 2002-09-30 | 2005-03-22 | Medtronic, Inc. | Cardiac vein lead and guide catheter |
DE60325999D1 (en) | 2002-12-04 | 2009-03-12 | Cook Inc | DEVICE FOR TREATING THE THORAX AORTA |
US6849084B2 (en) | 2002-12-31 | 2005-02-01 | Intek Technology L.L.C. | Stent delivery system |
EP1589903B1 (en) | 2003-01-15 | 2016-01-13 | Angiomed GmbH & Co. Medizintechnik KG | Trans-luminal surgical device |
US7309349B2 (en) | 2003-01-23 | 2007-12-18 | Cordis Corporation | Friction reducing lubricant for stent loading and stent delivery systems |
US7611528B2 (en) | 2003-01-24 | 2009-11-03 | Medtronic Vascular, Inc. | Stent-graft delivery system |
US20040260382A1 (en) | 2003-02-12 | 2004-12-23 | Fogarty Thomas J. | Intravascular implants and methods of using the same |
WO2004071352A1 (en) | 2003-02-14 | 2004-08-26 | Salviac Limited | Stent delivery and deployment system |
US20040193141A1 (en) | 2003-02-14 | 2004-09-30 | Leopold Eric W. | Intravascular flow modifier and reinforcement device and deployment system for same |
US6859986B2 (en) | 2003-02-20 | 2005-03-01 | Cordis Corporation | Method system for loading a self-expanding stent |
WO2004080504A2 (en) | 2003-03-10 | 2004-09-23 | Wilson-Cook Medical, Inc. | Stent introducer apparatus |
US7220274B1 (en) | 2003-03-21 | 2007-05-22 | Quinn Stephen F | Intravascular stent grafts and methods for deploying the same |
WO2004093746A1 (en) | 2003-03-26 | 2004-11-04 | The Foundry Inc. | Devices and methods for treatment of abdominal aortic aneurysm |
US6984244B2 (en) | 2003-03-27 | 2006-01-10 | Endovascular Technologies, Inc. | Delivery system for endoluminal implant |
US7637934B2 (en) | 2003-03-31 | 2009-12-29 | Merit Medical Systems, Inc. | Medical appliance optical delivery and deployment apparatus and method |
EP1608294B1 (en) | 2003-04-02 | 2007-12-26 | Boston Scientific Limited | Detachable and retrievable stent assembly |
US7530995B2 (en) | 2003-04-17 | 2009-05-12 | 3F Therapeutics, Inc. | Device for reduction of pressure effects of cardiac tricuspid valve regurgitation |
GB0310715D0 (en) | 2003-05-09 | 2003-06-11 | Angiomed Ag | Strain management in stent delivery system |
US7947070B2 (en) | 2003-05-16 | 2011-05-24 | Boston Scientific Scimed, Inc. | Dilatation and stent delivery system and related methods |
US20040267281A1 (en) | 2003-06-25 | 2004-12-30 | Eran Harari | Delivery system for self-expandable diverter |
US20050033406A1 (en) | 2003-07-15 | 2005-02-10 | Barnhart William H. | Branch vessel stent and graft |
US6945990B2 (en) | 2003-08-16 | 2005-09-20 | Medtronic Vascular, Inc. | Double sheath deployment system |
EP1660173B1 (en) | 2003-08-26 | 2010-06-16 | Zerusa Limited | A haemostasis device |
US7780716B2 (en) | 2003-09-02 | 2010-08-24 | Abbott Laboratories | Delivery system for a medical device |
US7794489B2 (en) | 2003-09-02 | 2010-09-14 | Abbott Laboratories | Delivery system for a medical device |
US20070198078A1 (en) | 2003-09-03 | 2007-08-23 | Bolton Medical, Inc. | Delivery system and method for self-centering a Proximal end of a stent graft |
US8500792B2 (en) | 2003-09-03 | 2013-08-06 | Bolton Medical, Inc. | Dual capture device for stent graft delivery system and method for capturing a stent graft |
US8292943B2 (en) * | 2003-09-03 | 2012-10-23 | Bolton Medical, Inc. | Stent graft with longitudinal support member |
US9198786B2 (en) | 2003-09-03 | 2015-12-01 | Bolton Medical, Inc. | Lumen repair device with capture structure |
US20080264102A1 (en) | 2004-02-23 | 2008-10-30 | Bolton Medical, Inc. | Sheath Capture Device for Stent Graft Delivery System and Method for Operating Same |
US7763063B2 (en) | 2003-09-03 | 2010-07-27 | Bolton Medical, Inc. | Self-aligning stent graft delivery system, kit, and method |
US7758625B2 (en) | 2003-09-12 | 2010-07-20 | Abbott Vascular Solutions Inc. | Delivery system for medical devices |
US8088156B2 (en) | 2003-10-07 | 2012-01-03 | Cordis Corporation | Graft material attachment device and method |
US7967829B2 (en) | 2003-10-09 | 2011-06-28 | Boston Scientific Scimed, Inc. | Medical device delivery system |
CA2541807C (en) | 2003-10-10 | 2012-07-10 | William Cook Europe Aps | Stent graft retention system |
EP1673038B1 (en) | 2003-10-10 | 2008-04-23 | William A. Cook Australia Pty. Ltd. | Fenestrated stent grafts |
WO2005034807A1 (en) | 2003-10-10 | 2005-04-21 | William A. Cook Australia Pty. Ltd | Composite stent graft |
US20050096725A1 (en) | 2003-10-29 | 2005-05-05 | Pomeranz Mark L. | Expandable stent having removable slat members |
EP1684668B1 (en) | 2003-11-08 | 2018-10-17 | Cook Medical Technologies LLC | Aorta and branch vessel stent grafts and system |
AU2004299000B8 (en) | 2003-12-11 | 2010-07-22 | Cook Medical Technologies Llc | Hemostatic valve assembly |
US8257430B2 (en) | 2003-12-17 | 2012-09-04 | Cook Medical Technologies Llc | Interconnected leg extensions for an endoluminal prosthesis |
US20050159804A1 (en) | 2004-01-20 | 2005-07-21 | Cook Incorporated | Multiple stitches for attaching stent to graft |
DE602005015186D1 (en) | 2004-01-20 | 2009-08-13 | Cook Inc | ENDOLUMINAL STENT GRAFT WITH SEPARATE FIXING |
WO2005072244A2 (en) | 2004-01-23 | 2005-08-11 | Eva Corporation | Apparatus and method for performing a surgical procedure |
US7225518B2 (en) | 2004-02-23 | 2007-06-05 | Boston Scientific Scimed, Inc. | Apparatus for crimping a stent assembly |
JP2007532250A (en) | 2004-04-12 | 2007-11-15 | クック・インコーポレイテッド | Stent graft repair device |
JP2007537842A (en) | 2004-05-20 | 2007-12-27 | メッド・インスティテュート・インコーポレイテッド | Enhanced biological fixation of grafts |
US8043354B2 (en) | 2004-06-16 | 2011-10-25 | William A. Cook Australia Pty. Ltd. | Thoracic deployment device and stent graft |
US20050288766A1 (en) | 2004-06-28 | 2005-12-29 | Xtent, Inc. | Devices and methods for controlling expandable prostheses during deployment |
US7758626B2 (en) | 2004-07-20 | 2010-07-20 | Medtronic Vascular, Inc. | Device and method for delivering an endovascular stent-graft having a longitudinally unsupported portion |
CN100352406C (en) | 2004-08-17 | 2007-12-05 | 微创医疗器械(上海)有限公司 | Combined membrane-covered stent capable of being bent in any direction |
US7699883B2 (en) | 2004-10-25 | 2010-04-20 | Myles Douglas | Vascular graft and deployment system |
US7451765B2 (en) | 2004-11-18 | 2008-11-18 | Mark Adler | Intra-bronchial apparatus for aspiration and insufflation of lung regions distal to placement or cross communication and deployment and placement system therefor |
US7402151B2 (en) | 2004-12-17 | 2008-07-22 | Biocardia, Inc. | Steerable guide catheters and methods for their use |
US20060155366A1 (en) | 2005-01-10 | 2006-07-13 | Laduca Robert | Apparatus and method for deploying an implantable device within the body |
CA2593670A1 (en) | 2005-01-21 | 2006-07-27 | Gen4 Llc. | Modular stent graft employing bifurcated graft and leg locking stent elements |
US7918880B2 (en) | 2005-02-16 | 2011-04-05 | Boston Scientific Scimed, Inc. | Self-expanding stent and delivery system |
EP2253338B1 (en) | 2005-03-02 | 2012-05-30 | Cook Medical Technologies LLC | Introducer Sheath |
CN2817768Y (en) | 2005-05-24 | 2006-09-20 | 微创医疗器械(上海)有限公司 | Tectorium stand and host cage section thereof |
US7938851B2 (en) | 2005-06-08 | 2011-05-10 | Xtent, Inc. | Devices and methods for operating and controlling interventional apparatus |
WO2007005799A1 (en) | 2005-06-30 | 2007-01-11 | Abbott Laboratories | Delivery system for a medical device |
WO2007008533A1 (en) | 2005-07-07 | 2007-01-18 | Med Institute, Inc. | Branch vessel stent graft |
US7833259B2 (en) | 2005-07-25 | 2010-11-16 | Cook Incorporated | Fenestrated endoluminal stent system |
US7914809B2 (en) | 2005-08-26 | 2011-03-29 | Boston Scientific Scimed, Inc. | Lubricious composites for medical devices |
WO2007025174A2 (en) | 2005-08-26 | 2007-03-01 | Vascular And Endovascular Surgical Technologies, Inc. | Endograft |
ES2360185T3 (en) | 2005-09-01 | 2011-06-01 | Medtronic Vascular, Inc. | METHODS AND APPARATUS FOR THE TREATMENT OF AORTA TORÁCICA ANEURISMS. |
US8702787B2 (en) | 2005-09-02 | 2014-04-22 | Medtronic Vascular, Inc. | Endoluminal prosthesis |
US8968379B2 (en) | 2005-09-02 | 2015-03-03 | Medtronic Vascular, Inc. | Stent delivery system with multiple evenly spaced pullwires |
US20070053952A1 (en) | 2005-09-07 | 2007-03-08 | Medtronic Vascular, Inc. | Nitric oxide-releasing polymers derived from modified polymers |
US20070083252A1 (en) | 2005-09-27 | 2007-04-12 | Mcdonald Michael B | Method for placing a stent through a constricted lumen, and medical device |
AU2006330816B2 (en) | 2005-12-23 | 2012-05-24 | Cook Medical Technologies Llc | Prosthesis deployment system |
US20070156223A1 (en) | 2005-12-30 | 2007-07-05 | Dennis Vaughan | Stent delivery system with improved delivery force distribution |
US20070156228A1 (en) | 2006-01-03 | 2007-07-05 | Majercak David C | Prosthetic stent graft for treatment of abdominal aortic aneurysm |
US20070162109A1 (en) | 2006-01-11 | 2007-07-12 | Luis Davila | Intraluminal stent graft |
EP1971299B1 (en) | 2006-01-13 | 2014-07-16 | C.R. Bard, Inc. | Stent delivery system |
US8083792B2 (en) | 2006-01-24 | 2011-12-27 | Cordis Corporation | Percutaneous endoprosthesis using suprarenal fixation and barbed anchors |
US8585753B2 (en) | 2006-03-04 | 2013-11-19 | John James Scanlon | Fibrillated biodegradable prosthesis |
US20070244545A1 (en) | 2006-04-14 | 2007-10-18 | Medtronic Vascular, Inc. | Prosthetic Conduit With Radiopaque Symmetry Indicators |
US20070250151A1 (en) | 2006-04-24 | 2007-10-25 | Scimed Life Systems, Inc. | Endovascular aortic repair delivery system with anchor |
US8439961B2 (en) | 2006-07-31 | 2013-05-14 | Boston Scientific Scimed, Inc. | Stent retaining mechanisms |
US20080269865A1 (en) | 2006-08-07 | 2008-10-30 | Xtent, Inc. | Custom Length Stent Apparatus |
JP5392655B2 (en) | 2006-08-18 | 2014-01-22 | クック・メディカル・テクノロジーズ・リミテッド・ライアビリティ・カンパニー | Stent grafting system |
AU2007294534B2 (en) | 2006-09-08 | 2012-11-01 | Edwards Lifesciences Corporation | Integrated heart valve delivery system |
US20080071343A1 (en) | 2006-09-15 | 2008-03-20 | Kevin John Mayberry | Multi-segmented graft deployment system |
AU2007305383A1 (en) | 2006-09-28 | 2008-04-10 | Cook Incorporated | Thoracic aortic aneurysm repair apparatus and method |
DE102006053748B3 (en) | 2006-11-09 | 2008-04-10 | Jotec Gmbh | Insert system for inserting and releasing e.g. endovascular stent, has fixing system with cover unit including pivoting units axially extending in proximal direction of insert system, and retaining unit arranged proximal to cover unit |
US8052732B2 (en) | 2006-11-14 | 2011-11-08 | Medtronic Vascular, Inc. | Delivery system for stent-graft with anchoring pins |
US7615072B2 (en) | 2006-11-14 | 2009-11-10 | Medtronic Vascular, Inc. | Endoluminal prosthesis |
WO2008066923A1 (en) | 2006-11-30 | 2008-06-05 | William Cook Europe Aps | Implant release mechanism |
US20080140175A1 (en) | 2006-12-07 | 2008-06-12 | Boucher Donald D | Spring stop for stent delivery system and delivery system provided with same |
AU2007342106B2 (en) | 2007-01-03 | 2013-01-24 | Cook Medical Technologies Llc | Valve assembly |
US8523931B2 (en) | 2007-01-12 | 2013-09-03 | Endologix, Inc. | Dual concentric guidewire and methods of bifurcated graft deployment |
WO2008098252A2 (en) | 2007-02-09 | 2008-08-14 | Taheri Laduca Llc | Vascular implants and methods of fabricating the same |
US8075482B2 (en) | 2007-02-22 | 2011-12-13 | Ethicon Endo-Surgery, Inc. | IRIS valve with control ring |
US20080262590A1 (en) | 2007-04-19 | 2008-10-23 | Medtronic Vascular, Inc. | Delivery System for Stent-Graft |
JP5364933B2 (en) | 2007-08-13 | 2013-12-11 | クック・メディカル・テクノロジーズ・リミテッド・ライアビリティ・カンパニー | Placement device |
US20090163951A1 (en) | 2007-12-19 | 2009-06-25 | Sara Simmons | Medical devices including sutures with filaments comprising naturally derived collagenous material |
US9393115B2 (en) | 2008-01-24 | 2016-07-19 | Medtronic, Inc. | Delivery systems and methods of implantation for prosthetic heart valves |
ES2638293T3 (en) | 2008-06-30 | 2017-10-19 | Bolton Medical Inc. | Abdominal aortic aneurysm systems |
US8652202B2 (en) | 2008-08-22 | 2014-02-18 | Edwards Lifesciences Corporation | Prosthetic heart valve and delivery apparatus |
WO2010027485A1 (en) | 2008-09-05 | 2010-03-11 | Med Institute, Inc. | Apparatus and methods for improve stent deployment |
EP2617388B2 (en) | 2008-10-10 | 2019-11-06 | Boston Scientific Scimed, Inc. | Medical devices and delivery systems for delivering medical devices |
WO2010080427A1 (en) | 2008-12-18 | 2010-07-15 | Med Institute, Inc. | Stents and stent grafts |
US9101506B2 (en) | 2009-03-13 | 2015-08-11 | Bolton Medical, Inc. | System and method for deploying an endoluminal prosthesis at a surgical site |
US20110071614A1 (en) | 2009-09-24 | 2011-03-24 | David Christopher Majercak | Stent - graft suture locks |
US20110087318A1 (en) | 2009-10-09 | 2011-04-14 | Daugherty John R | Bifurcated highly conformable medical device branch access |
WO2011056638A1 (en) | 2009-10-27 | 2011-05-12 | Bolton Medical, Inc. | Endovascular grafts and methods of use |
US20110251664A1 (en) | 2010-04-08 | 2011-10-13 | Medtronic Vascular, Inc. | Short Legged Bifurcated Stent Graft Distal Capture Element and Method |
US8579963B2 (en) | 2010-04-13 | 2013-11-12 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery device with stability tube and method |
US9301864B2 (en) | 2010-06-08 | 2016-04-05 | Veniti, Inc. | Bi-directional stent delivery system |
WO2012036741A2 (en) | 2010-09-17 | 2012-03-22 | St. Jude Medical, Cardiology Division, Inc. | Staged deployment devices and methods for transcatheter heart valve delivery |
CN104023673B (en) | 2011-11-11 | 2017-07-28 | 波顿医疗公司 | General endovascular graft thing |
EP3272312B1 (en) | 2011-11-16 | 2019-05-22 | Bolton Medical, Inc. | Device for aortic branched vessel repair |
ES2618221T3 (en) | 2012-04-12 | 2017-06-21 | Bolton Medical Inc. | Vascular prosthesis administration device and method of use |
US10098767B2 (en) | 2012-04-27 | 2018-10-16 | Medtronic Vascular, Inc. | Reconfigurable stent-graft delivery system and method of use |
US9439751B2 (en) | 2013-03-15 | 2016-09-13 | Bolton Medical, Inc. | Hemostasis valve and delivery systems |
CN106687074A (en) | 2014-09-23 | 2017-05-17 | 波顿医疗公司 | Vascular repair devices and methods of use |
EP3040058A1 (en) | 2014-12-29 | 2016-07-06 | Cook Medical Technologies LLC | Deployment handle for a delivery device with mechanism for quick release of a prosthesis and re-sheathing of device tip |
EP3439583B1 (en) | 2016-04-05 | 2020-09-09 | Bolton Medical, Inc. | Stent graft with internal tunnels and fenestrations |
WO2017176674A1 (en) | 2016-04-05 | 2017-10-12 | Bolton Medical, Inc. | Delivery systems with introducer and distal sheaths and methods of use |
EP3463184B1 (en) | 2016-05-25 | 2021-12-22 | Bolton Medical, Inc. | Stent grafts for treating aneurysms |
US20180206972A1 (en) | 2016-08-10 | 2018-07-26 | Bolton Medical, Inc. | Graft prosthesis coupler, modular system, and methods of use |
-
2004
- 2004-02-23 US US10/784,462 patent/US8292943B2/en not_active Expired - Lifetime
- 2004-09-02 BR BRPI0414109A patent/BRPI0414109B8/en not_active IP Right Cessation
- 2004-09-02 WO PCT/US2004/028530 patent/WO2005023149A2/en active Application Filing
- 2004-09-02 AT AT06025851T patent/ATE430536T1/en not_active IP Right Cessation
- 2004-09-02 ES ES06025851T patent/ES2327150T3/en not_active Expired - Lifetime
- 2004-09-02 DE DE602004021041T patent/DE602004021041D1/en not_active Expired - Lifetime
- 2004-09-02 DK DK06025851T patent/DK1776938T3/en active
- 2004-09-02 AU AU2004270186A patent/AU2004270186B2/en not_active Ceased
- 2004-09-02 EP EP04782926.2A patent/EP1673033B1/en not_active Expired - Lifetime
-
2006
- 2006-02-06 US US11/348,176 patent/US8308790B2/en active Active
- 2006-03-02 IL IL174066A patent/IL174066A/en active IP Right Grant
- 2006-03-03 KR KR1020067004586A patent/KR101260518B1/en active IP Right Grant
- 2006-06-08 US US11/449,337 patent/US8740963B2/en active Active
-
2007
- 2007-01-30 US US11/699,700 patent/US20070203566A1/en not_active Abandoned
- 2007-01-30 US US11/699,701 patent/US8007605B2/en active Active
- 2007-01-31 US US11/700,609 patent/US9320631B2/en active Active
- 2007-01-31 US US11/700,510 patent/US8062349B2/en active Active
-
2011
- 2011-03-04 US US13/040,755 patent/US20110208288A1/en not_active Abandoned
-
2012
- 2012-08-03 US US13/566,412 patent/US8636788B2/en not_active Expired - Lifetime
-
2013
- 2013-12-13 US US14/105,751 patent/US9408734B2/en not_active Expired - Lifetime
-
2014
- 2014-01-16 US US14/157,194 patent/US9408735B2/en not_active Expired - Lifetime
-
2016
- 2016-04-15 US US15/099,974 patent/US10182930B2/en not_active Expired - Lifetime
- 2016-07-22 US US15/217,464 patent/US9925080B2/en not_active Expired - Lifetime
- 2016-07-22 US US15/217,486 patent/US9913743B2/en not_active Expired - Lifetime
-
2018
- 2018-12-17 US US16/222,820 patent/US10918509B2/en not_active Expired - Lifetime
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5292331A (en) * | 1989-08-24 | 1994-03-08 | Applied Vascular Engineering, Inc. | Endovascular support device |
US5902334A (en) * | 1993-04-22 | 1999-05-11 | C.R. Bard, Inc. | Method and apparatus for recapture of hooked endoprosthesis |
US6355056B1 (en) * | 1995-06-01 | 2002-03-12 | Meadox Medicals, Inc. | Implantable intraluminal prosthesis |
US20020138133A1 (en) * | 1999-11-09 | 2002-09-26 | Scimed Life Systems, Inc. | Stent with variable properties |
Cited By (72)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9456910B2 (en) | 2003-06-27 | 2016-10-04 | Medinol Ltd. | Helical hybrid stent |
US10363152B2 (en) | 2003-06-27 | 2019-07-30 | Medinol Ltd. | Helical hybrid stent |
US9956320B2 (en) | 2003-06-27 | 2018-05-01 | Zuli Holdings Ltd. | Amorphous metal alloy medical devices |
US9603731B2 (en) | 2003-06-27 | 2017-03-28 | Medinol Ltd. | Helical hybrid stent |
US9925080B2 (en) | 2003-09-03 | 2018-03-27 | Bolton Medical, Inc. | Methods of implanting a prosthesis |
US9561124B2 (en) | 2003-09-03 | 2017-02-07 | Bolton Medical, Inc. | Methods of self-aligning stent grafts |
US8292943B2 (en) | 2003-09-03 | 2012-10-23 | Bolton Medical, Inc. | Stent graft with longitudinal support member |
US8308790B2 (en) | 2003-09-03 | 2012-11-13 | Bolton Medical, Inc. | Two-part expanding stent graft delivery system |
US8449595B2 (en) | 2003-09-03 | 2013-05-28 | Bolton Medical, Inc. | Delivery systems for delivering and deploying stent grafts |
US8500792B2 (en) | 2003-09-03 | 2013-08-06 | Bolton Medical, Inc. | Dual capture device for stent graft delivery system and method for capturing a stent graft |
US8636788B2 (en) | 2003-09-03 | 2014-01-28 | Bolton Medical, Inc. | Methods of implanting a prosthesis |
US8740963B2 (en) | 2003-09-03 | 2014-06-03 | Bolton Medical, Inc. | Methods of implanting a prosthesis and treating an aneurysm |
US11813158B2 (en) | 2003-09-03 | 2023-11-14 | Bolton Medical, Inc. | Stent graft delivery device |
US11596537B2 (en) | 2003-09-03 | 2023-03-07 | Bolton Medical, Inc. | Delivery system and method for self-centering a proximal end of a stent graft |
US11413173B2 (en) | 2003-09-03 | 2022-08-16 | Bolton Medical, Inc. | Stent graft with a longitudinal support member |
US11259945B2 (en) | 2003-09-03 | 2022-03-01 | Bolton Medical, Inc. | Dual capture device for stent graft delivery system and method for capturing a stent graft |
US9173755B2 (en) | 2003-09-03 | 2015-11-03 | Bolton Medical, Inc. | Vascular repair devices |
US20080077226A1 (en) * | 2003-09-03 | 2008-03-27 | Bolton Medical, Inc. | Stent Graft Delivery System Handle |
US9220617B2 (en) | 2003-09-03 | 2015-12-29 | Bolton Medical, Inc. | Dual capture device for stent graft delivery system and method for capturing a stent graft |
US9320631B2 (en) | 2003-09-03 | 2016-04-26 | Bolton Medical, Inc. | Aligning device for stent graft delivery system |
US9333104B2 (en) | 2003-09-03 | 2016-05-10 | Bolton Medical, Inc. | Delivery systems for delivering and deploying stent grafts |
US11103341B2 (en) | 2003-09-03 | 2021-08-31 | Bolton Medical, Inc. | Stent graft delivery device |
US9408734B2 (en) | 2003-09-03 | 2016-08-09 | Bolton Medical, Inc. | Methods of implanting a prosthesis |
US9408735B2 (en) | 2003-09-03 | 2016-08-09 | Bolton Medical, Inc. | Methods of implanting a prosthesis and treating an aneurysm |
US10945827B2 (en) | 2003-09-03 | 2021-03-16 | Bolton Medical, Inc. | Vascular repair devices |
US8062349B2 (en) | 2003-09-03 | 2011-11-22 | Bolton Medical, Inc. | Method for aligning a stent graft delivery system |
US10918509B2 (en) | 2003-09-03 | 2021-02-16 | Bolton Medical, Inc. | Aligning device for stent graft delivery system |
US10646365B2 (en) | 2003-09-03 | 2020-05-12 | Bolton Medical, Inc. | Delivery system and method for self-centering a proximal end of a stent graft |
US10390929B2 (en) | 2003-09-03 | 2019-08-27 | Bolton Medical, Inc. | Methods of self-aligning stent grafts |
US9913743B2 (en) | 2003-09-03 | 2018-03-13 | Bolton Medical, Inc. | Methods of implanting a prosthesis and treating an aneurysm |
US10213291B2 (en) | 2003-09-03 | 2019-02-26 | Bolto Medical, Inc. | Vascular repair devices |
US9655712B2 (en) | 2003-09-03 | 2017-05-23 | Bolton Medical, Inc. | Vascular repair devices |
US10182930B2 (en) | 2003-09-03 | 2019-01-22 | Bolton Medical, Inc. | Aligning device for stent graft delivery system |
US9877857B2 (en) | 2003-09-03 | 2018-01-30 | Bolton Medical, Inc. | Sheath capture device for stent graft delivery system and method for operating same |
US9907686B2 (en) | 2003-09-03 | 2018-03-06 | Bolton Medical, Inc. | System for implanting a prosthesis |
US10105250B2 (en) | 2003-09-03 | 2018-10-23 | Bolton Medical, Inc. | Dual capture device for stent graft delivery system and method for capturing a stent graft |
US9198786B2 (en) | 2003-09-03 | 2015-12-01 | Bolton Medical, Inc. | Lumen repair device with capture structure |
US20080264102A1 (en) * | 2004-02-23 | 2008-10-30 | Bolton Medical, Inc. | Sheath Capture Device for Stent Graft Delivery System and Method for Operating Same |
US10864097B2 (en) | 2008-06-30 | 2020-12-15 | Bolton Medical, Inc. | Abdominal aortic aneurysms: systems and methods of use |
US11382779B2 (en) | 2008-06-30 | 2022-07-12 | Bolton Medical, Inc. | Abdominal aortic aneurysms: systems and methods of use |
US20100030255A1 (en) * | 2008-06-30 | 2010-02-04 | Humberto Berra | Abdominal aortic aneurysms: systems and methods of use |
US10307275B2 (en) | 2008-06-30 | 2019-06-04 | Bolton Medical, Inc. | Abdominal aortic aneurysms: systems and methods of use |
US9364314B2 (en) | 2008-06-30 | 2016-06-14 | Bolton Medical, Inc. | Abdominal aortic aneurysms: systems and methods of use |
US10105248B2 (en) | 2008-06-30 | 2018-10-23 | Bolton Medical, Inc. | Abdominal aortic aneurysms: systems and methods of use |
US9101506B2 (en) | 2009-03-13 | 2015-08-11 | Bolton Medical, Inc. | System and method for deploying an endoluminal prosthesis at a surgical site |
US10898357B2 (en) | 2009-03-13 | 2021-01-26 | Bolton Medical, Inc. | System for deploying an endoluminal prosthesis at a surgical site |
US9827123B2 (en) | 2009-03-13 | 2017-11-28 | Bolton Medical, Inc. | System for deploying an endoluminal prosthesis at a surgical site |
US20100274350A1 (en) * | 2009-04-22 | 2010-10-28 | Medinol Ltd. | Helical hybrid stent |
US9155639B2 (en) * | 2009-04-22 | 2015-10-13 | Medinol Ltd. | Helical hybrid stent |
US20120197376A1 (en) * | 2011-02-01 | 2012-08-02 | Aga Medical Corporation | Vascular delivery system and method |
US9486348B2 (en) * | 2011-02-01 | 2016-11-08 | S. Jude Medical, Cardiology Division, Inc. | Vascular delivery system and method |
US11446167B2 (en) | 2011-11-11 | 2022-09-20 | Bolton Medical, Inc. | Universal endovascular grafts |
US9592112B2 (en) | 2011-11-16 | 2017-03-14 | Bolton Medical, Inc. | Device and method for aortic branched vessel repair |
US11547549B2 (en) | 2011-11-16 | 2023-01-10 | Bolton Medical, Inc. | Aortic graft assembly |
US10390930B2 (en) | 2011-11-16 | 2019-08-27 | Bolton Medical, Inc. | Method for aortic branched vessel repair |
US11351049B2 (en) | 2012-04-12 | 2022-06-07 | Bolton Medical, Inc. | Vascular prosthetic delivery device and method of use |
US10299951B2 (en) | 2012-04-12 | 2019-05-28 | Bolton Medical, Inc. | Vascular prosthetic delivery device and method of use |
US11998469B2 (en) | 2012-04-12 | 2024-06-04 | Bolton Medical, Inc. | Vascular prosthetic delivery device and method of use |
US8998970B2 (en) | 2012-04-12 | 2015-04-07 | Bolton Medical, Inc. | Vascular prosthetic delivery device and method of use |
US9554929B2 (en) | 2012-04-12 | 2017-01-31 | Bolton Medical, Inc. | Vascular prosthetic delivery device and method of use |
US20140257362A1 (en) * | 2013-03-07 | 2014-09-11 | St. Jude Medical, Cardiology Division, Inc. | Filtering and removing particulates from bloodstream |
US11666467B2 (en) | 2013-03-15 | 2023-06-06 | Bolton Medical, Inc. | Hemostasis valve and delivery systems |
US10555826B2 (en) | 2013-03-15 | 2020-02-11 | Bolton Medical, Inc. | Hemostasis valve and delivery systems |
US9439751B2 (en) | 2013-03-15 | 2016-09-13 | Bolton Medical, Inc. | Hemostasis valve and delivery systems |
US10864069B2 (en) | 2013-06-21 | 2020-12-15 | Boston Scientific Scimed, Inc. | Stent with deflecting connector |
US9907640B2 (en) | 2013-06-21 | 2018-03-06 | Boston Scientific Scimed, Inc. | Stent with deflecting connector |
US10524893B2 (en) | 2014-09-23 | 2020-01-07 | Bolton Medical, Inc. | Vascular repair devices and methods of use |
US11918451B2 (en) | 2014-09-23 | 2024-03-05 | Bolton Medical, Inc. | Vascular repair devices and methods of use |
US10390932B2 (en) | 2016-04-05 | 2019-08-27 | Bolton Medical, Inc. | Stent graft with internal tunnels and fenestrations and methods of use |
US11154392B2 (en) | 2016-04-05 | 2021-10-26 | Bolton Medical, Inc. | Stent graft with internal tunnels and fenestrations and methods of use |
US11395750B2 (en) | 2016-05-25 | 2022-07-26 | Bolton Medical, Inc. | Stent grafts and methods of use for treating aneurysms |
CN110520082A (en) * | 2017-03-06 | 2019-11-29 | 心血管实验室股份公司和布雷维蒙特 Cv 实验室股份公司 | Multilayer endoluminal prosthesis component and its manufacturing method |
Also Published As
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US11813158B2 (en) | Stent graft delivery device | |
US10918509B2 (en) | Aligning device for stent graft delivery system |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: BOLTON MEDICAL, INC., FLORIDA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ARBEFEUILLE, SAMUEL;BERRA, HUMBERTO;SIGNING DATES FROM 20070321 TO 20070322;REEL/FRAME:026438/0094 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |