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
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2/958—Inflatable balloons for placing stents or stent-grafts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/856—Single tubular stent with a side portal passage

Definitions

• the present invention relates generally to medical devices and methods. More particularly, the present invention relates to apparatus and methods for delivering stents and other luminal prostheses to bifurcations in the vasculature and other body lumens.
• Stenting is a common medical procedure used in the vasculature and other body lumens.
• stents and other vascular prostheses have become wide spread in the revascularzation of stenotic blood vessels where the blood vessel is first dilated and a stent placed to maintain vessel patency following the procedure.
• the stents are typically small, mesh-like tubular devices which are expanded in situ. They are typically formed from a metal and can be coated with drugs or other active agents.
• stents and in particular drug-coated stents, has been very successful in the treatment of many forms for coronary artery disease.
• the success of stents has been more limited for the treatment of lesions occurring at vessel bifurcations. While the disease in the main vessel is generally treated successfully, the outcome in the smaller or "side branch" vessel is often less successful.
• the lack of success is believed to result from a lack of coverage by the stent at the ostium (opening) of a lesion and the resulting lack of drug delivery to that area.
• Stents having side holes or openings for alignment with side branch lumens are generally known in the art, and a variety of protocols and systems for delivering such stents to vascular and other luminal bifurcations are known.
• several guidewire systems have been proposed for delivering such stents to a luminal bifurcation and for aligning the side hole with a side branch ostium prior to expansion of the stent.
• U.S. Patent No. 5,749,825 to Fischell et al. describes introducing a balloon catheter carrying the stent over a main vessel guidewire.
• a side branch tube is positioned beneath a proximal portion of the stent and over the exterior of the balloon.
• a distal portion of the side branch tube extends through a side hole in the stent and permits advancement of a side branch guidewire into the side branch vessel. While generally effective for aligning the side hole of the stent with the side branch, the unconstrained distal portion of the side branch tube which extends from the side hole can interfere with advancement of the catheter through the vasculature. The presence of the side branch tube can increase the profile of the catheter, thus making it more difficult to introduce to smaller blood vessels and body lumens. Finally, Fischell suggests no specific approach for assuring that the two guidewires have not become crossed at the bifurcation so that the side hole is misaligned with the side branch ostium.
• Such devices, systems, and methods should be compatible with small diameter (low profile) catheter structures, should reduce or eliminate any structure which exposed at or through the side openings in the stent or prostheses, and should allow for conformation of proper positioning of the side hole prior to expansion of the stent or other prostheses. At least some of these objectives will be met by the inventions described herein below.
• Patents and published applications describing bifurcated stents and delivery systems include U.S. Patent Nos. 4,994,071; 5,609,627; 5,749,825; 5,755,735; 5,928,248; 6,048,361; 6,099,497; 6,165,195; 6,221,098; 6,210,429; 6,325,826; 6,596,020; 6,599,316; 6,676,691; 6,682,536; 6,689,156; 6,692,483; 6,709,440; 6,706,062; 6,835,203; 6,884,258; U.S. Publication Nos.
• the present invention provides apparatus and systems for the delivery of vascular and other luminal prostheses having side openings at bifurcations in the vasculature or other body lumens.
• Bifurcations will usually include a main branch vessel and a side branch vessel, where the cylindrical body of the prosthesis will be positioned within the main branch with the side opening aligned with an ostium or opening into the side branch.
• the apparatus and systems will be particularly useful for delivering prostheses having self- opening side structures, as taught in co-pending U.S. Patent Application No.
• a delivery catheter comprises a catheter shaft having a proximal end and a distal end.
• An expansion member such as an inflatable balloon, is disposed near the distal end of the shaft, and an expandable prosthesis is mounted over the expansion member.
• the expandable prosthesis will typically be formed from a deformable metal so that expansion of the expansion member will enlarge the prosthesis from a small diameter configuration to a large diameter configuration which is anchored within the main vessel of the vasculature or other body lumen being treated.
• the prosthesis will further have a side hole, optionally in the form of a self-opening side structure, which is to be aligned with an ostium of the side branch lumen after the prosthesis has been expanded.
• side hole includes any opening or structure which is to be aligned with an ostium of a side branch lumen or vessel.
• the side hole may simply be a cell or a slit in the prosthesis structure which is preselected to be aligned with a side branch vessel but which is otherwise similar to other cells, slits, or the like in the prosthesis. More usually, however, the side hole will be an enlarged or enlargeable cell which is distinguishable from the adjacent or remaining structure of the prosthesis.
• the "hole” comprises a self-opening or balloon openable peripheral structure which is intended to bridge the circumference of the side branch ostium after the prosthesis is opened in the main branch.
• Such alignment is achieved with a guidewire structure which is disposed over the expansion member (optionally over or within the folds of an inflatable balloon) and beneath a proximal portion of the prosthesis.
• the guidewire structure will extend to a holding location which is spaced proximally from the side hole of the prosthesis, usually by a distance of at least 1 mm, preferably at least 2 mm, and more preferably at least 3 mm.
• the guidewire structure may have a variety of configurations.
• the guidewire structure comprises a guidewire tube which carries the guidewire in a lumen thereof.
• the guidewire tube will be positioned between the prostheses and the expandable member, as just described, and the guidewire will remain in the guidewire tube with a distal end retracted fully within the tube during advancement of the catheter to a position near the bifurcation.
• the guidewire structure may comprise an elongate slide having a channel which slidably receives the guidewire.
• the channel can be formed, for example, as a "half tube" with an open top which can be oriented either toward the balloon or toward an inner surface of the prosthesis.
• the guidewire structure may consist essentially or only of the guidewire itself. That is, the guidewire may be directly placed between the inner surface of the prosthesis and the outer surface of the expandable member without any further structure surrounding it. In all cases, however, the guidewire and any other structure associated with the guidewire will be withdrawn proximally of the side hole by the requisite distances described above.
• the delivery catheters of the present invention will preferably further comprise a central guidewire extending distally from the catheter shaft, hi some instances, the central guidewire could be fixed to (combined and immobilized with) the catheter shaft, but more often the central guidewire will be a conventional moveable guidewire, either in a over-the- wire design (which extends fully or almost fully through the entire catheter shaft), in a rapid exchange design where the guidewire extends only through a distal portion of the catheter shaft, or in other conventional simplified exchange designs.
• a delivery catheter comprises a catheter shaft, an expansion member, and an expandable prosthesis having a side hole, generally as described above.
• the guidewire is disposed over the expansion member and beneath at least a proximal portion of the prosthesis so that the guidewire is advanceable through the side hole.
• the guidewire may extend partially or fully to side hole and in some instances through the side hole of the prosthesis even while the catheter is being advanced through the vasculature toward the bifurcation, hi this aspect of the invention, the catheter shaft includes a split lumen along at least a portion of its length for removably receiving a proximal portion of the side guidewire.
• the split lumen is particularly useful for constraining the side guidewire in embodiments where a main guidewire is received only in a distal portion of the catheter shaft (typically to facilitate rapid exchange). In such instances, the side guidewire could become entangled or twisted with the main guidewire if both guidewires were free of the catheter shaft structure.
• the split lumen would preferably be used to constrain the side guidewire, but could be used for the main or the side guidewires. hi other embodiments, it would be possible to enlarge the split lumen to receive both wires or to provide two split lumens for receiving both the main guidewire and the side guidewire.
• the delivery catheter will usually comprise a central guidewire, either a fixed central guidewire or moveable central guidewire.
• the side guidewire may be received in a guidewire tube, in a guidewire slide, or maybe disposed directly between the expandable member and an inner surface of the prosthesis, hi this aspect of the invention, the guidewire and any other guidewire structure may also extend through the side hole in the prosthesis even when the catheter is in its delivery configuration for advancement through the main vessel.
• methods for delivering a prosthesis having a side hole (as defined above) to a luminal location.
• the methods comprise advancing a catheter over a central guidewire through a main lumen, such as an artery or other blood vessel, to position the prosthesis near the bifurcation.
• a side guidewire is then advanced through the side hole into a branch lumen of the bifurcation, and the prosthesis is eventually expanded at the bifurcation with the side hole aligned with the side branch.
• radiopaque markers are provided on the prosthesis and/or on the guidewire so that the positions may be observed under fluoroscopy.
• the catheter may be rotated until it is apparent under the fluoroscopic imaging that the guidewire is no longer crossing the prosthesis and the side hole is therefore rotationally aligned with the side branch ostium.
• This method for rotationally aligning the prosthesis is compatible with any of the catheter systems described previously where the side guidewire extends through the side hole of the prosthesis to aid in alignment of the side hole with the side branch ostium, including systems which require a separate balloon to deploy a side structure on the prosthesis into the ostium of the side branch.
• Fig. 1 is an isometric view of a delivery catheter constructed in accordance with the principles of the present invention.
• Fig. 2 is an enlarged view of a distal portion of the catheter of Fig. 1, shown with an expanded prosthesis in broken line.
• Fig. 3 is an enlarged view of a proximal portion of the delivery catheter of Fig. 1.
• Fig. 4 is a cross-sectional symmetric view taken along line 4-4 of Fig. 3.
• Fig. 5 illustrates a side guidewire which is useful in the apparatus and methods of the present invention.
• Figs. 6A and 6B illustrate positioning of a guidewire tube beneath a prosthesis mounted on an expandable member in accordance with the principles of the present invention.
• Figs. 7A and 7B illustrate positioning of a guidewire slide positioned beneath the prosthesis and over an expandable member in accordance with the principles of the present invention.
• FIGs. 8A and 8B illustrate a guidewire which is positioned without additional supporting structure beneath a prosthesis and over and expandable member in accordance with the principles of the present invention.
• FIGs. 9A through 9E illustrate use of the delivery catheters of the present invention for implanting a prosthesis having a side hole at an ostium of a side branch in the vasculature of a patient in accordance with the principles of the present invention.
• Figs. 1OA and 1OB illustrate an optional aspect of the method of the present invention for assuring that the side guidewire does not cross the prosthesis as the prosthesis is expanded.
• a delivery catheter 10 carries a prosthesis 12 having a side hole 15 (Fig. 2) on an expandable member 14, such as an inflatable balloon of the type normally employed in stent delivery.
• the delivery catheter 10 further comprises a distal section 16, an intermediate section 18, and a proximal section 20, where the sections are arranged to provide an elongate catheter body to support the expandable member 14 so that it may be delivered intraluminally or intravascularly to a target site in a generally conventional manner.
• the distal and intermediate sections 18 will be relatively more flexible than the proximal section 20.
• a proximal hub 22 having a connector 24 for connection to a balloon inflater is attached to a proximal end of the proximal section 20.
• the hub can have any design including a y-shaped hub, a hub with flexible connector, and the like.
• a central guidewire 26 is received through the balloon and exits from a port near the proximal end of distal section 16 of the catheter body.
• the shaft of the delivery catheter 10 could also be adapted for over- the-wire introduction over the central guidewire 26, or any other know or future design.
• a side guidewire 28 is disposed beneath a proximal portion of the prosthesis 12 and over the expandable member 14.
• the side guidewire may be disposed in a guidewire tube, guidewire slide, or without further supporting structure.
• the side guidewire 28 is disposed in a guidewire tube 30 which extends beneath the prosthesis 12.
• the side guidewire 28 passes into a lumen within the catheter shaft through a port 34 and passes back out of the shaft through a proximal port 36 (Fig. 1).
• the prosthesis 12 will have a side hole 15, preferably in the form of a self-opening or other side structure, as shown in broken line in Fig. 2. Details of a self-opening side structure are provided in copending application no. 11/330,382, the full disclosure of which has previously been incorporated herein by reference.
• the proximal section 20 of the delivery catheter may optionally be formed with a split side lumen 34 for removably receiving the side guidewire 28, as best seen in Fig. 4.
• This section can be formed over a hypotube 36 with a polymeric extrusion 38 over the hypotube forming the split guidewire lumen 34.
• Open lumen 40 through the hypotube will serve as the inflation lumen for the catheter.
• the split side guidewire lumen is particularly advantageous since it allows the guidewire to be constrained during advancement of the catheter. By constraining the side guidewire, the chance of crossing or otherwise entangling the side guidewire 28 with the main guidewire 26 is greatly reduced.
• the polymeric tube may be extended separately and may be separate from the hypotube.
• an exemplary side guidewire 40 comprises a round proximal section 42, a reduced diameter round transition section 44, and a flat distal section 42.
• a radiopaque coil 46 joins the distal end of the flat section 42 optionally with an atraumatic distal sphere 48.
• the guidewire can be formed from stainless steel, shape memory materials, or other conventional guidewire materials, and will have dimensions normally associated with guidewires for intravascular or other luminal uses.
• the delivery catheters of the present invention can be used with a variety of other guidewires, including very low profile guidewires which can further reduce the diameter of the catheter system.
• guidewire 28 is disposed in a guidewire tube 50 which is located beneath a proximal portion of the prosthesis 12 and over an outer surface of the expandable member 14.
• a distal tip 52 of the guidewire tube is located by a minimum distance Z from the closest point of the side hole 15.
• the distance i will generally be at least 1 mm, preferably being at least 2 mm, and often being 3 mm or more.
• the guidewire 28 will be fully retracted within the guidewire tube 50, as shown in Fig. 6A. Once the catheter has been advanced to the bifurcation, the guidewire 28 may be advanced distally and through the opening 15 so that it may be guided to the side branch, as shown in Fig. 6B.
• the side guidewire 28 may be disposed in a guidewire slide 60 having a region 62 which is open on the side adjacent the prosthesis 12.
• the guidewire 28 may be received in a channel formed by the open region of the slide 60 which provides a guide to help advance the guidewire through the opening 15, as shown in Fig. 7B.
• the distal most end of the guidewire 28 and guidewire slide 60 will be maintained by the minimum distance H. from the closest portion of the opening 15.
• guidewire 28 may be disposed directly between the inner surface of the prosthesis 12 and the outer surface of the expandable member 14, as shown in Figs. 8 A and 8B. Again, the distal tip of the guidewire 28 will be maintained at a minimum distance £ from the closest portion of the opening 15 in the prosthesis. Once the catheter has been advanced to a location near the bifurcation, the side guidewire may be advanced through the opening, as shown in Fig. 8B.
• FIGs. 9 A through 9E an example of the delivery of prosthesis 12 using the delivery catheter 10 to a branch lumen comprising a main vessel MV and a side vessel SV will be described.
• the central guidewire 26 is advanced through the main vessel to a point beyond the ostium O of the side vessel SV, as shown in Fig. 9 A.
• the catheter 10 may be advanced over the central guidewire 26 in the conventional manner until the prosthesis 12 approaches the ostium O of the side vessel SV.
• the side guidewire 28 is shown in the guidewire tube 50, but it will be appreciated that any of the guidewire structures of Fig. 6-8 could be employed.
• the side guidewire 28 is next distally advanced through the opening 15 of prosthesis 12, as shown in Fig. 9C, and the guidewire is then advanced through the ostium O and into the side vessel SV, as shown in Fig. 9D.
• the catheter may be advanced so that the opening 15 in the prosthesis 12 approaches and eventually aligns with the ostium O.
• the balloon or other expandable member 14 may then be inflated so that the prosthesis 12 expands within the main vessel MV and the side opening (shown as a self- opening side structure) aligns with the ostium O, as shown in Fig. 9D.
• the side guidewire will have a stiffer section near its distal end to improve system alignment.
• the side guidewire 28 may be radiopaque (or include radiopaque markers) and/or radiopaque markers may be provided on a side of the prosthesis 12 aligned with the side opening 15.
• radiopaque structures allow the physician to easily determine whether the prosthesis is rotationally misaligned with the ostium O of the side vessel SV.
• Fig. 1OA when the prosthesis is rotationally misaligned, the side guidewire will extend across the prosthesis 12. Expansion of the prosthesis 12 in this position will of course not result in alignment of the side opening 15 with the ostium O.
• such misalignment can dissect or perforate the artery or other treated lumen.
• the catheter can then be torqued to rotate the prosthesis 12 so that the opening 15 is adjacent the ostium O with the side guidewire 28 positioned as shown in Fig. 1OB.
• This configuration is readily observed under fluoroscopic imaging since the radiopaque markers 70 on the prosthesis 12 (generally adjacent to the opening 15) will be adjacent to the ostium O. Additionally, the radiopaque side guidewire 28 can be observed going directly from the opening into the side branch vessel SV. In this configuration, the prosthesis may be deployed by expanding the expandable member 14.

Landscapes

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

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• 2006
  • 2006-04-17 US US11/406,139 patent/US7922754B2/en not_active Expired - Fee Related
  • 2006-04-18 JP JP2008506826A patent/JP5114385B2/ja not_active Expired - Fee Related
  • 2006-04-18 WO PCT/US2006/014653 patent/WO2006113763A2/en not_active Ceased
  • 2006-04-18 EP EP06750644A patent/EP1871293A4/en not_active Withdrawn
• 2011
  • 2011-03-09 US US13/044,392 patent/US8608791B2/en not_active Expired - Fee Related
• 2013
  • 2013-11-15 US US14/081,827 patent/US9339402B2/en active Active

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