US20030144731A1 - Radially-expandable stent and delivery system - Google Patents
Radially-expandable stent and delivery system Download PDFInfo
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- US20030144731A1 US20030144731A1 US10/364,612 US36461203A US2003144731A1 US 20030144731 A1 US20030144731 A1 US 20030144731A1 US 36461203 A US36461203 A US 36461203A US 2003144731 A1 US2003144731 A1 US 2003144731A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
-
- 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
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91583—Adjacent bands being connected to each other by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0037—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in height or in length
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- 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)
- Physics & Mathematics (AREA)
- Optics & Photonics (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The present invention provides radially-expandable stents that, in various embodiments, may reduce the bending stresses/strains associated with the compressed state of self-expanding stents and/or may prevent longitudinal expansion/contraction of radially expandable stents between the compressed and expanded states. In addition, stents according to the present invention preferably exhibit increased longitudinal flexibility in both the compressed and expanded states. The present invention also includes delivery systems in which threading of the guidewire through the delivery system may be simplified. In addition, the delivery systems according to the present invention may also incorporate a balloon to assist in radially expanding the stent and/or seating of the stent in the lumen during deployment without removing the stent delivery catheter. Further, the delivery systems may also include a support tube at the proximal end to assist in fixing the position of the stent relative to a guide catheter during deployment of the stent.
Description
- The present invention relates to intravascular stent implants for maintaining vascular patency in humans and animals. More particularly, the present invention provides a radially-expandable stent and a delivery system for delivering a radially-expandable stent within a body lumen.
- Percutaneous transluminal coronary angioplasty (PTCA) is used to increase the lumen diameter of a coronary artery partially or totally obstructed by a build-up of cholesterol fats or atherosclerotic plaque. Typically a first guidewire of about 0.038 inches in diameter is steered through the vascular system to the site of therapy. A guiding catheter, for example, can then be advanced over the first guidewire to a point just proximal of the stenosis. The first guidewire is then removed. A balloon catheter on a smaller 0.014 inch diameter second guidewire is advanced within the guiding catheter to a point just proximal of the stenosis. The second guidewire is advanced into the stenosis, followed by the balloon on the distal end of the catheter. The balloon is inflated causing the site of the stenosis to widen.
- The dilatation of the occlusion, however, can form flaps, fissures and dissections which threaten reclosure of the dilated vessel or even perforations in the vessel wall. Implantation of a stent can provide support for such flaps and dissections and thereby prevent reclosure of the vessel or provide a patch repair for a perforated vessel wall until corrective surgery can be performed. It has also been shown that the use of intravascular stents can measurably decrease the incidence of restenosis after angioplasty thereby reducing the likelihood that a secondary angioplasty procedure or a surgical bypass operation will be necessary.
- An implanted prosthesis such as a stent can preclude additional procedures and maintain vascular patency by mechanically supporting dilated vessels to prevent vessel reclosure. Stents can also be used to repair aneurysms, to support artificial vessels as liners of vessels or to repair dissections. Stents are suited to the treatment of any body lumen, including the vas deferens, ducts of the gallbladder, prostate gland, trachea, bronchus and liver. The body lumens range in diameter from small coronary vessels of 3 mm or less to 28 mm in the aortic vessel. The invention applies to acute and chronic closure or reclosure of body lumens.
- A typical stent is a cylindrically shaped wire formed device intended to act as a permanent prosthesis. A typical stent ranges from 5 mm to 50 mm in length. A stent is deployed in a body lumen from a radially compressed configuration into a radially expanded configuration which allows it to contact and support a body lumen. The stent can be made to be radially self-expanding or expandable by the use of an expansion device. The self expanding stent is made from a resilient springy material while the device expandable stent is made from a material which is plastically deformable. A plastically deformable stent can be implanted during a single angioplasty procedure by using a balloon catheter bearing a stent which has been crimped onto the balloon. The stent expands radially as the balloon is inflated forcing the stent into contact with the interior of the body lumen thereby forming a supporting relationship with the vessel walls.
- Conventional angioplasty balloons fall into high, medium and low pressure ranges. Low pressure balloons are those which fall into rated burst pressures below 6 atmospheres. Medium pressure balloons are those which fall into rated burst pressures between 6 and 12 atmospheres. High pressure balloons are those which fall into rated burst pressures above 12 atmospheres. Burst pressure is determined by material selection, wall thickness and tensile strength.
- The biocompatible metal stent props open blocked coronary arteries, keeping them from reclosing after balloon angioplasty. A balloon of appropriate size and pressure is first used to open the lesion. The process is repeated with a stent crimped on a second balloon. The second balloon may be a high pressure type of balloon, e.g., more than 12 atmospheres, to insure that the stent is fully deployed upon inflation. The stent is deployed when the balloon is inflated. The stent remains as a permanent scaffold after the balloon is withdrawn. A high pressure balloon is preferable for stent deployment because the stent must be forced against the artery's interior wall so that it will fully expand thereby precluding the ends of the stent from hanging down into the channel encouraging the formation of thrombus.
- Various shapes of stents are known in the art. U.S. Pat. No. 4,649,922 (Wiktor) discloses a linearly expandable spring-like stent. U.S. Pat. No. 4,886,062 (Wiktor) discloses a two-dimensional zigzag form, typically a sinusoidal form. U.S. Pat. No. 4,969,458 (Wiktor) discloses a stent wire coiled into a limited number of turns wound in one direction, then reversed and wound in the opposite direction with the same number of turns, then reversed again and so on until a desired length is obtained.
- Stents have limited ability to provide effective patching of perforated vessels due to the spacing between metal elements. U.S. Pat. No. 4,878,906 (Lindeman et al.) describes an endoprosthesis made of a thin wall molded plastic sleeve intended to be collapsed radially and delivered to a damaged area of a vessel where it is expanded to provide a sealed interface to the vessel on its outer peripheral ends. The endoprosthesis therefore provides a patch which prevents leakage of blood from a vessel wall. The endoprosthesis disclosed employs various molded-in ribs, struts and the like to adapt the device for particular applications and to provide the desired degree of stiffness to form the sealed interface with the vessel wall. Such a stiff prosthesis, however, could not be expected to have the longitudinal flexibility needed to adapt to curved vessels.
- One problem with self-expanding stents is that the stents must be compressed into a small diameter for delivery to the site or portion of the body lumen at which support is desired. It is preferable that the stents be compressed into as small of a diameter as possible (typically referred to as “profile”) to assist in delivering the stent to the desired site. That compression can, in some cases cause localized areas of high bending stress/strain within the stent.
- As a result of the high bending stresses/strain, the minimum profile for the self-expanding stents can be limited to prevent non-recoverable strain levels in the stent and, therefore, ensure full radial expansion of the stent when released from the delivery system. The larger profile can limit the delivery and use of the stent to larger diameter lumens.
- Alternatively, if a small delivery profile is desired, then the stent may be designed to achieve that profile which can often result in a larger window area and a reduction in the outward forces generated by the stent after expansion within the lumen. The larger window area and, therefore, inferior body lumen scaffolding reduces the effectiveness against recurring restenosis. The reduced outward forces may be problematic if the stent does not firmly engage the wall of the lumen.
- One attempt at addressing the high bending stresses/strains in a self-expanding stent is described in U.S. Pat. No. 4,830,003 (Wolff et al.) in which the stent is made of a series of generally straight wire segments welded together at their ends to form a zigzag shaped stent when expanded. By using generally straight wires, the bending stresses/strains associated with bends in an integral wire-formed stent body can be avoided. Disadvantages associated with this approach include, however, the cost of manufacturing the stents by welding. The welds also lower the allowable stress levels in the stent, thereby limiting its fatigue life and compression for delivery. Another disadvantage is that the length of the stent can change significantly from the compressed state to the expanded state, thereby making accurate placement of the stent at the desired location within a body lumen more difficult.
- Another attempt at addressing the high bending stresses/strains includes manufacturing self-expanding stents from materials other than metals as described in, e.g., U.S. Pat. No. 5,356,423 (Tihon et al.). The stents disclosed therein are formed of thermoplastic materials and can be molded or otherwise formed into a fenestrated pattern similar to those produced by braided wire stents. By shaping the openings as depicted in FIG. 5 of the patent, the stress concentration at the bending points can be reduced. Disadvantages of this approach include, however, degradation associated with implanted plastic materials, including changes in the elasticity of the plastics which can result in a reduction in the radially outward forces generated by the stent.
- It is an object of the invention to provide a self-expanding stent for implantation within a body lumen that provides for reductions in the bending stresses/strains associated with compression of the stent for delivery to the desired location within a body lumen.
- It is another object of the present invention to provide a self-expanding stent in which the longitudinal length of the stent remains unchanged from the compressed state to the expanded state.
- It is a further object of the invention to provide a stent with improved longitudinal flexibility to allow for threading through tortuous lumens and lesions, as well as to permit implantation in highly curved lumens.
- It is an object of some delivery systems according to the present invention to provide a delivery system in which the position of the stent can be fixed relative to a guide catheter.
- It is another object of some delivery systems according to the present invention to provide a balloon integral with the stent delivery device to allow for post-deployment dilatation of the stent without removing the stent delivery catheter.
- It is another object of some delivery systems of the present invention to provide for simplified threading of a guidewire through a distal portion of a rapid-exchange delivery system.
- In one aspect, the present invention provides radially expandable stent for implantation within a body lumen including an elongated generally tubular body defining a passageway having a longitudinal axis; the body including a plurality of circumferential support sections arranged successively along the longitudinal axis, each of the support sections having a length along the longitudinal axis; each of the circumferential support sections including a plurality of primary bends interconnected by struts, the primary bends being located on alternating ends of the support section around the circumference of the body, each of the struts connecting successive primary bends on opposite ends of the support section and having a midpoint generally located therebetween; and at least one longitudinal member connecting adjacent support sections in the body, the longitudinal member having a first end attached proximate the midpoint of one of the struts and a second end attached proximate the midpoint of one of the struts in the adjacent support section; wherein the stent is radially compressible into a compressed state in which the struts are generally aligned with the longitudinal axis and radially expandable into an expanded state in which the struts and the primary bends in each of the support sections are arranged in a zigzag pattern, and further wherein the longitudinal length of the stent in the compressed state is substantially the same as the longitudinal length of the stent in the expanded state.
- In another aspect the present invention provides a self-expanding radially expandable stent for implantation within a body lumen including an elongated generally tubular body defining a passageway having a longitudinal axis, the body including at least one circumferential support section having a length along the longitudinal axis; each of the circumferential support sections including a plurality of primary bends interconnected by struts, the primary bends being located on alternating ends of the support section around the circumference of the body, each of the struts connecting successive primary bends on opposite ends of the support section and having a midpoint generally located therebetween; wherein the stent is radially compressible into a compressed state and radially expandable into an expanded state in which the struts and primary bends in each of the support sections are arranged in a zigzag pattern, and further wherein each pair of adjacent struts associated with each of the primary bends abut at a point between the primary bend and the midpoint of each strut in the pair of adjacent struts when the stent is in the compressed state, whereby the bending stress is reduced at each primary bend of the plurality of primary bends.
- In another aspect, the present invention provides a self-expanding radially expandable stent for implantation within a body lumen including an elongated generally tubular body defining a passageway having a longitudinal axis, the body including at least one circumferential support section having a length along the longitudinal axis; each of the circumferential support sections including a substantially continuous element including a plurality of primary bends interconnected by struts, the primary bends being located on alternating ends of the support section around the circumference of the body, each of the struts connecting successive primary bends on opposite ends of the support section and having a midpoint generally located therebetween, wherein the stent is radially compressible into a compressed state and radially expandable into an expanded state in which the struts and primary bends in each of the support sections are arranged in a zigzag pattern; and means for reducing bending stress at the primary bends when the stent is in the compressed state.
- In another aspect, the present invention provides a delivery system for implantation of a radially-expandable stent within a body lumen including an inner tube having a proximal end and a distal end, the inner tube having an inner tube lumen formed therein, the inner tube lumen having an opening at the distal end of the inner tube; a cover sheath having a proximal end and a distal end, the cover sheath comprising a wall defining a cover sheath lumen, the inner tube located within the cover sheath lumen; a stent positioned about the inner tube at the distal end of the cover sheath; a first guidewire opening in the inner tube lumen, the first guidewire opening spaced from the distal end of the inner tube; a second guidewire opening in the wall of the cover sheath, the second guidewire opening located proximate the first guidewire opening; and a guide element having a distal end located within the inner tube lumen, the guide element extending between the first and second guidewire openings.
- In another aspect, the present invention provides a method of deploying a stent within a body lumen by providing a radially expandable stent on a delivery system including an inner tube having a proximal end and a distal end, the inner tube having an inner tube lumen formed therein, the inner tube lumen having an opening at the distal end of the inner tube and a first guidewire opening in the inner tube lumen, the first guidewire opening spaced from the distal end of the inner tube; a stent positioned on the exterior surface of the inner tube at the distal end of the inner tube; a cover sheath having a proximal end and a distal end, the cover sheath comprising a wall defining a cover sheath lumen, the inner tube and stent located within the cover sheath lumen, the cover sheath further including a second guidewire opening in the wall of the cover sheath, the second guidewire opening located proximate the first guidewire opening in the inner tube; and a guide element having a distal end located within the inner tube lumen, the guide element extending between the first and second guidewire openings, wherein the guide element comprises a guide lumen formed in the distal end of the guide element; positioning a guidewire within a body lumen, wherein a proximal end of the guidewire extends out of the body lumen; inserting the proximal end of the guidewire into the inner tube lumen at the distal end of the inner tube; advancing the proximal end of the guidewire through the inner tube lumen towards the first guidewire opening and the distal end of the guide element, wherein at least a portion of the proximal end of the guidewire is advanced into the guide lumen in the distal end of the guide element; advancing the proximal end of the guidewire through the first and second guidewire openings; advancing the distal end of the inner tube and the stent over the guidewire towards the distal end of the guidewire, wherein the stent is positioned at a desired location within the body lumen; and deploying the stent at the desired location within the body lumen.
- In another aspect, the present invention provides a method of deploying a stent within a body lumen by providing a radially expandable stent on a delivery system including an inner tube having a proximal end and a distal end, the inner tube having an inner tube lumen formed therein; a stent positioned on the exterior surface of the inner tube at the distal end of the inner tube; an expandable balloon located on the inner tube; an inflation lumen in fluid communication with the balloon, the inflation lumen extending from the proximal end of the delivery system to the balloon; and a cover sheath having a proximal end and a distal end, the cover sheath comprising a wall defining a cover sheath lumen, the inner tube, stent, and balloon located within the cover sheath lumen; positioning the inner tube, stent, balloon and cover sheath within a body lumen; moving the cover sheath proximally relative to the distal end of the inner tube to deploy the stent with the body lumen; and inflating the balloon within the stent.
- In another aspect, the present invention provides a method of deploying a stent within a body lumen by providing a radially expandable stent on a delivery system including an inner tube having a proximal end and a distal end; a stent positioned on the exterior surface of the inner tube at the distal end of the inner tube; a cover sheath having a proximal end and a distal end, the cover sheath including a cover sheath lumen, the inner tube and stent located within the cover sheath lumen; and a support tube having a proximal end and a distal end, the support tube including a support tube lumen containing at least a portion of the proximal end of the cover sheath, the cover sheath being movable in the proximal and distal directions within the support tube lumen and the position of the inner tube being fixed relative to the position of the support tube; positioning a guide catheter within a body lumen; advancing the distal ends of the inner tube and the cover sheath through the guide catheter; fixing the position of the support tube relative to the guide catheter, wherein the positions of the distal end of the inner tube and the stent within the body lumen are also fixed relative to the guide catheter; and moving the cover sheath proximally to release the stent on the distal end of the inner tube, thereby deploying the stent within the body lumen.
- These and other features and advantages of the present invention are described below in connection the description of the preferred embodiments.
- FIG. 1 is a perspective view of one radially expanded stent according to the present invention.
- FIG. 2 is a plan view of the stent of FIG. 1 in which the body of the stent is unrolled.
- FIG. 3 is an enlarged partial view of the stent body of FIG. 2 in the expanded state.
- FIG. 4 is an enlarged partial view of the stent body of FIG. 2 in the compressed state.
- FIGS.5-8 are enlarged partial views of portions of alternative stents according to the present invention.
- FIG. 9 is a schematic diagram of one delivery system according to the present invention.
- FIG. 10 is an enlarged cross-sectional view of the delivery system of FIG. 9 taken along line10-10 in FIG. 9.
- FIG. 11 is an enlarged cross-sectional view of the distal end of the delivery system of FIG. 9.
- FIG. 12 is an enlarged cross-sectional view of the distal end of an alternate delivery system incorporating a balloon.
- FIG. 13 is an enlarged partial cross-sectional view of one rapid-exchange delivery system according to the present invention.
- The present invention includes radially-expandable stents that, in various embodiments, may reduce the bending stresses/strains associated with the compressed state of self-expanding stents and/or may prevent longitudinal expansion/contraction of radially expandable stents between the compressed and expanded states. In addition, stents according to the present invention preferably exhibit increased longitudinal flexibility in both the compressed and expanded states.
- The present invention also includes delivery systems in which threading of the guidewire through the delivery system may be simplified. In addition, the delivery systems according to the present invention may also incorporate a balloon to assist in radially expanding the stent and/or seating of the stent in the lumen during deployment without removing the stent delivery catheter. Further, the delivery systems may also include a support tube at the proximal end to assist in fixing the position of the stent relative to a guide catheter during deployment of the stent.
- Although the following discussion, along with the figures, describes illustrative preferred embodiments and methods according to the present invention, those skilled in the art will understand that other structures and/or methods could also be used to accomplish the desired functions. For example, although stents having one or more support sections are described herein, it will be understood that stents manufactured according to the present invention could have any number of desired support sections needed to obtain a stent with a desired longitudinal length. Furthermore, it will be understood that the figures are schematic only, and that the relative dimensions of the various illustrated features are not intended to limit the scope of the present invention.
- FIG. 1 depicts one illustrative self-expanding stent according to the present invention. The depicted stent includes a generally
tubular body 10 defining apassageway 12 extending along alongitudinal axis 14. Thebody 10 is preferably formed from a plurality ofsupport sections longitudinal axis 14. Thebody 10 is depicted in FIG. 1 in its expanded state in which the support sections 20 have been expanded radially outward from thelongitudinal axis 14. - FIG. 2 is a plan view of a portion of the
body 10 of the stent depicted in FIG. 1 in which the body has been unrolled from the tubular shape of FIG. 1. Each of the support sections 20 is depicted and has a length along thelongitudinal axis 14. - Referring specifically to support
section 20 a, thesupport section 20 a includes a plurality ofprimary bends support section 20 a.Primary bend 22 on one end of thesupport section 20 a is connected to aprimary bend 22′ by astrut 24. Because of the alternating nature of the primary bends 22 and 22′, the primary bends 22/22′ and struts 24 are arranged in a zigzag pattern when the stent is in the expanded state (as in FIGS. 1 and 2). -
Adjacent support sections longitudinal member 40 extending between thesupport sections longitudinal members 40 are attached to thestruts 24, although they may be attached at any location on each of the support sections 20. More preferably, thelongitudinal members 40 are attached to thestruts 24 at the midpoint of the length of thestruts 24 between theprimary bends longitudinal members 40 at the midpoints of the struts, the length of thebody 10 of the stent along thelongitudinal axis 14 will exhibit substantially no change between the compressed state and the expanded state. - Although most of the adjacent support sections20 are connected by only one
longitudinal member 40 in FIG. 2, it should be noted that a plurality oflongitudinal members 40 can be used to connect the support sections 20. For example,support sections longitudinal members 40 in FIG. 2. Where more than onelongitudinal member 40 is used to connect adjacent support sections 20, it is preferred that the longitudinal members be spaced evenly about the circumference of thebody 10. For example, where twolongitudinal members 40 are provided, it is preferred that they be located about 180 degrees apart, threelongitudinal members 40 would preferably be located about 120 degrees apart, etc. - It may be preferred (but not required) that smaller stents, i.e., those having a diameter as manufactured of about 6 millimeters or less, employ two or more
longitudinal members 40 to connect adjacent support sections 20. It may also be preferred (but not required) that larger stents, i.e., those having manufactured diameters of about 5 millimeters or more, employ three or morelongitudinal members 40 to connect adjacent support sections 20. The exact number of longitudinal members used in any stent according to the present invention will, however, vary based on the need for longitudinal flexibility - It is preferred that the
longitudinal members 40 connecting immediately adjacent support sections 20 are not aligned along thelongitudinal axis 14 of the stent. As one example of this, the arrangement of thelongitudinal members 40 in the first threesupport sections longitudinal members 40 connectingsupport sections longitudinal axis 14 with thelongitudinal members 40 connectingsupport sections support sections longitudinal members 40 connectingsupport sections support sections longitudinal members 180 degrees apart, it is preferred that thelongitudinal members 40 connectingsupport sections longitudinal members 40 connecting thesupport sections - Providing
longitudinal members 40 connecting immediately adjacent support sections 20, e.g., 20 a and 20 b, circumferentially spaced about the support sections 20 can improve the flexibility of thebody 10 along thelongitudinal axis 14. In addition, providing thelongitudinal members 40 tangentially out of phase along the length of thebody 10, e.g., between sections 20 a-20 b and 20 b-20 c, can also improve the longitudinal flexibility of stents according to the present invention. Although these concepts have been described with reference to three successive support sections, it will be understood that these concepts can be extended along the entire length of a stent incorporating as few as two support sections and as many support sections as desired. - It is significant to note that the longitudinal bending flexibility is improved both when the stent is in the compressed state during delivery and upon deployment of the stent in a body lumen. Increased longitudinal bending flexibility when compressed permits threading of the stent through long tortuous vessels and lesions. Increased longitudinal bending flexibility when expanded allows for deployment in highly curved vessels or lumens.
- It will be understood that the
longitudinal members 40 described above may be incorporated into self-expanding stents or into stents that are not self-expanding, i.e., stents that must be expanded by a balloon or some other method. In addition, the connection of thelongitudinal members 40 can be used in any stent providing zigzag support sections, whether the stent includes primary bends such as those described herein or not. In any case, the connection of thelongitudinal members 40 the midpoints of thestruts 24 in adjacent zigzag support sections 20 will prevent changes in the longitudinal length of stents incorporating zigzag support sections similar to those described herein. - FIG. 3 is an enlarged view of a portion of the one of the support sections20 in FIG. 2. A
primary bend 22 is shown along with two opposing primary bends 22′ on the opposite end of the support section. Theprimary bend 22 is attached to a pair ofstruts lower strut 24 a is attached to the lower opposingprimary bend 22′ while theupper strut 24 b is attached to the upper opposingprimary bend 22′.Strut 24 a has amidpoint 25 a that is generally located midway between theprimary bend 22 and the lower opposingprimary bend 22′ whilestrut 24 b has amidpoint 25 b that is generally located midway between theprimary bend 22 and the upper opposingprimary bend 22′. -
Strut 24 a includes asecondary bend 26 a located between itsmidpoint 25 a and theprimary bend 22. Thesecondary bend 26 a forms an apex 27 a facing theother strut 24 b attached to theprimary bend 22.Strut 24 b includes asecondary bend 26 b located between itsmidpoint 25 b and theprimary bend 22. Thesecondary bend 26 b forms an apex 27 b facing theother strut 24 a attached to theprimary bend 22. As depicted in FIGS. 2 and 3, it is preferred that each of thestruts 24 connectingprimary bends strut 24. - FIG. 4 depicts the portion of the support section of FIG. 3 in the compressed state in which the opposing upper and lower primary bends22′ are moved together. As a result, the
struts midpoints respective struts primary bend 22 abut first is at theapexes struts primary bend 22 during compression of the stent is limited by the abutting relationship of theapexes struts - The construction of the supports sections depicted in FIGS.2-4 can be modified while still limiting the maximum stresses associated with compression of the stent. One alternative is depicted in FIG. 5 and includes a
primary bend 122 on one end of a support section and two opposingprimary bends 122′ on the opposing end of the support section. Thestrut 124 a connecting theprimary bend 122 with the lower opposingprimary bend 122′ includes asecondary bend 126 a and thestrut 124 b connecting theprimary bend 122 with the upper opposingprimary bend 122′ includes asecondary bend 126 b. - The primary difference between the embodiments depicted in FIGS. 3 and 5 is that the
portion 123 a of thestrut 124 a between thesecondary bend 126 a and theprimary bend 122 is not generally parallel to thecorresponding portion 123 b of thestrut 124 b. As described with respect to the embodiment of FIG. 3 above, however, it is preferred that thestruts apexes secondary bends - Another alternative construction is depicted in FIG. 6 and includes a
primary bend 222 on one end of a support section and two opposingprimary bends 222′ on the opposing end of the support section. Thestrut 224 a connecting theprimary bend 222 with the lower opposingprimary bend 222′ includes asecondary bend 226 a and thestrut 224 b connecting theprimary bend 222 with the upper opposingprimary bend 222′ includes asecondary bend 226 b. - The
primary bend 222 in the embodiment of FIG. 6 and the portions of thestruts secondary bends primary bend 222 form a generally circular element as seen in FIG. 6. As described with respect to the embodiments of FIGS. 3 and 5 above, however, it is preferred that thestruts apexes secondary bends - Yet another alternative construction is depicted in FIG. 7 and includes a
primary bend 322 on one end of a support section and two opposingprimary bends 322′ on the opposing end of the support section. Thestrut 324 a connecting theprimary bend 322 with the lower opposingprimary bend 322′ includes aprotrusion 327 a facing the opposingstrut 324 b attached to theprimary bend 322. Similarly, thestrut 324 b connecting theprimary bend 322 with the upper opposingprimary bend 322′ includes aprotrusion 327 b facing the opposingstrut 324 a. - Although the
struts protrusions struts 324 a/324 b first abut when the stent is compressed. Because that point is removed from theprimary bend 322, the minimum bending radius of the primary bend is limited, thereby reducing the maximum bending stresses at the primary bends that is associated with compression of the stent. - FIG. 8 illustrates yet another feature of stents according to the present invention when compared to the stent depicted in FIG. 2. The view of FIG. 8 is a portion of a stent body including two
adjacent support sections Support section 420 a includesprimary bends 422 a on one end and opposingprimary bends 422 a′ on the opposite end of thesupport section 420 a. Similarly, thesupport section 420 b includesprimary bends 422 b on one end of thesupport section 420 b and opposingprimary bends 422 b′ on the opposite end of thesupport section 420 b. - In the embodiment depicted in FIG. 8, the primary bends422 a and 422 b in
adjacent support sections adjacent support sections support sections - FIG. 2 illustrates a stent in which the support sections20 are “out of phase” with the adjacent support sections because the primary bends 22 and 22′ on the adjacent support sections 20 do not generally align along the
longitudinal axis 14 as do the primary bends 422 a/422 b and 422 a′/422 b′ in the embodiment depicted in FIG. 8. - The radially expandable stents depicted and described above with respect to FIGS.1-8 are preferably formed as a one-piece, completely integral units from a thin-walled tube of suitable material. Typically, the stents will be cut or machined from a tube using, e.g., laser, water jet, EDM (electrical discharge machining), or chemical etching techniques. As a result, the stents can be formed without welds or joints. It is also envisioned, however, that stents according to the present invention could be formed from a sheet of material using, e.g., laser, water jet, EDM, or chemical etching techniques. If the stent was formed from a sheet of material, the
body 10 as seen in FIG. 2 would be formed into a tube and welded or otherwise joined along one side of the stent resulting in a series of welds or other joints along the length of the body. - Preferred materials for stents according to the present invention include those materials that can provide the desired functional characteristics with respect to biological compatibility, modulus of elasticity, etc. For example, it is preferred that the stents be biologically compatible, as well as be capable of significant recoverable strain to assume a low profile for delivery to a desired location within a body lumen. After release of the compressed stent, it is preferred that the stent be capable of radially expanding back to its original diameter.
- Particularly preferred materials for stents according to the present invention are nickel titanium alloys and other alloys that exhibit superelastic behavior, i.e., are capable of significant distortion without plastic deformation. Stents manufactured of such materials can be significantly compressed without plastic deformation, i.e., they are compressed such that the maximum strain level in the stent is below the recoverable strain limit of the material. Discussions relating to nickel titanium alloys and other alloys that exhibit behaviors suitable for stents according to the present invention can be found in, e.g., U.S. Pat. No. 5,597,378 (Jervis) and WO 95/31945 (Burmeister et al.). Nickel titanium alloys suitable for use in manufacturing stents according to the present invention can be obtained from, e.g., Memry Corp., Brookfield, Conn.
- The radially outward directed force developed by the stents according to the present invention serves two functions. One function is to hold the body lumen open against a force directed radially inward, e.g., a spasm, as well as preventing restriction of the passageway through the lumen by intimal flaps or dissections generated by, e.g., prior balloon angioplasty. Another function is to fix the position of the stent within the body lumen by intimate contact between the stent and the walls of the lumen. The outwardly directed forces must not be excessive, however, to avoid traumatization of the lumen walls by the stent.
- The diameters of some preferred stents when in the compressed state for delivery to a desired location within a body lumen is typically reduced from about two to about six times the diameter of the stents when in their expanded state before compression. For example, typical stents may have a compressed external diameter of about 1 millimeter to about 3 millimeters for delivery and an expanded external diameter in a body lumen of about 3 millimeters to about 15 millimeters when released from compression in a large arterial vessel. Some preferred stents used in coronary arteries may have a compressed external diameter of about 1 millimeter and an expanded external diameter in a body lumen of up to about 5 millimeters.
- In addition to ranges in diameters, it will also be understood that the stents according to the present invention can have any desired longitudinal length as required for a particular application. Furthermore, although the illustrative stents depicted in FIGS.1-8 have a plurality of successive support sections, it will be understood that some stents according to the present invention could be manufactured with only one support section (in which case no longitudinal members would be required to connect adjacent support sections).
- Having thus described radially expandable stents according to the present invention, we will now describe one delivery system suitable for deploying the self-expanding stents described above as well as other radially expandable stents. The delivery system depicted in FIGS.9-11 provides for delivery of a stent to a desired location within a body lumen. It will be understood that the stents described above may be deployed by any suitable delivery system and they are not to be limited to deployment by the delivery systems described below.
- The delivery system of FIG. 9 includes a
handle 50 at the proximal end. Thehandle 50 includes arelease button 51 that slides within achannel 52 located in thehandle 50. Preferably, therelease button 51 is actuated by a user's thumb to assist in one-handed delivery of the stent as discussed in more detail below. - It is preferred that the
release button 51 be locked or retained in position before delivery to prevent accidental or unwanted deployment of the stent from the delivery system. One preferred retaining mechanism is a bend or turn in the distal end of thechannel 52 such that thechannel 52 includes a circumferential portion at the distal end connecting to the otherwiselongitudinal channel 52 seen in FIG. 9. The retaining therelease button 51 in position at the distal end of the channel 52 (in the circumferential portion of the channel) until delivery of the stent is desired, at which time the button is moved circumferentially and then longitudinally along the length of thechannel 52 to release the stent as discussed in more detail below. - Those skilled in the art will understand that a variety of retaining mechanisms could be substituted for the preferred mechanism described above. Examples of suitable alternatives include, but are not limited to: a removable security band around the
handle 50 that must be removed to move therelease button 51 proximally, stoppers within thechannel 52 that must be removed to move therelease button 51 proximally, a detent mechanism in which the release button can be depressed radially inward to release thebutton 51 for movement within the channel, etc. - A
support tube 54 extends from the distal end of thehandle 50 and preferably extends into thehemostasis valve 94 of the Y-connector 92 of aguide catheter 90. Preferably, thesupport tube 54 terminates within theguide catheter 90 at a point near the Y-connector 92. Theguide catheter 90 preferably terminates at adistal end 96 spaced from the Y-connector 92. The construction of guide catheters, Y-connectors and hemostasis valves are well known and will not be described further. - FIG. 10 is a cross-sectional view of the proximal portion of the delivery system taken along the longitudinal axis of the
support tube 54 as indicated by line 1010 in FIG. 9. Thesupport tube 54 is coaxial with acover sheath 70 andinner tube 60, both of which are described in more detail below. It is preferred that thecover sheath 70 be movable within thesupport tube 54 and that thecover sheath 70 also be movable relative to theinner tube 60. Further, it is preferred that theinner tube 60 and thesupport tube 54 be fixed relative to each other. - FIG. 11 is an enlarged view of the distal portion of the delivery device in which the
stent 10 is located within thelumen 72 formed by thecover sheath 70. Thecover sheath 70 maintains thestent 10 in a compressed state in which thestent 10 has a diameter suitable for delivery to aninternal body lumen 100. Because thestent 10 is self-expanding, it is biased radially outward against the interior surface of thecover sheath 70 as depicted. - An
inner tube 60 preferably extends through thecover sheath 70 and thecompressed stent 10 as seen in FIG. 11. Theinner tube 60 also preferably includes aguidewire lumen 64 extending through to thedistal end 61 of theinner tube 60. For clarity, theguidewire 104 has been removed from theguidewire lumen 64 in theinner tube 60 of FIG. 11. - The preferred
inner tube 60 includes ashoulder 62 proximal to theproximal end 16 of thestent 10. Theshoulder 62 prevents thestent 10 from moving proximally with thecover sheath 70 during deployment because the outside diameter of theinner tube 60 at theshoulder 62 is greater than the inside diameter of thecompressed stent 10. As a result, the position of thestent 10 relative to theshoulder 62 oninner tube 60 is fixed when thecover sheath 70 is moved proximally during deployment of thestent 10 as described below. -
Inner tube 60 preferably extends to thehandle 50 of the delivery system depicted in FIG. 9. Furthermore, theinner tube 60 is preferably fixedly attached to thehandle 50 and is substantially inextensible along its length. As a result, the distance between thehandle 50 and theshoulder 62 on theinner tube 60 is fixed. Because the distance between theshoulder 62 and the handle. 50 is fixed, the distance between thehandle 50 and thecompressed stent 10 on the interior surface of thecover sheath 70 is also fixed during deployment. - The
stent 10 is released by moving thecover sheath 70 towards the proximal end of the delivery device, i.e., away from thedistal end 61 of theinner tube 60. Thecover sheath 70 is connected to an actuator such as arelease button 51 on thehandle 50 such that movement of thebutton 51 towards theproximal end 53 of thehandle 50 moves thecover sheath 70 in the proximal direction towards thehandle 50. If thestent 10 is self-expanding, that movement of thecover sheath 70 preferably removes the constraining forces on thecompressed stent 10, thereby allowing it to expand within thelumen 100. Actuators that accomplish the function of moving thecover sheath 70 relative to thehandle 50 other than the preferredrelease button 51 will be known to those skilled in the art. - To assist in positioning the
stent 10 during delivery, it is preferred that one radio-opaque marker 68 be provided on theinner tube 60 at theproximal end 16 of thestent 10 and another radio-opaque marker 74 be provided on thecover sheath 70 at thedistal end 18 of thestent 10. Movement of themarker 74 on thecover sheath 70 past themarker 68 on theinner tube 60 is preferably indicative of sufficient movement of thecover sheath 70 such that thestent 10 is no longer constrained by within thelumen 72 of the cover sheath has been deployed within thebody lumen 100. - FIG. 12 is an enlarged view of the distal portion of an alternative delivery system incorporating an
inflatable balloon 180 on theinner tube 160, with the balloon preferably located within the passageway formed by thecompressed stent 110. As described in connection with the embodiment depicted in FIG. 11, thestent 110 is located within thelumen 172 formed by thecover sheath 170. Thecover sheath 170 maintains thestent 110 in a compressed state in which thestent 110 has a diameter suitable for delivery to an internal body lumen. Because thestent 110 is self-expanding, it is biased radially outward against the interior surface of the cover sheath as depicted. - The
inner tube 160 also preferably includes aguidewire lumen 164 extending through to thedistal end 161 of theinner tube 160. Theinner tube 160 also includes ashoulder 162 at theproximal end 116 of thestent 110 to assist in deploying thestent 110 as described above in connection with FIG. 11.Inner tube 160 also preferably extends to the handle of a delivery system as described above in connection with FIG. 11. - As seen in FIG. 12, the portion of the
inner tube 160 on which theballoon 180 is mounted preferably has a reduced diameter to maintain a low profile while allowing room for theballoon 180. Theinner tube 160 also includes aninflation lumen 182 in fluid communication with the interior of thecollapsed balloon 180. Theinflation lumen 182 is used to deliver the fluids used to inflate theballoon 180 during deployment of thestent 110. Theinflation lumen 182 preferably terminates at the proximal end of theinner tube 160 where the fluid source can be connected by known methods. - To assist in positioning the
stent 110 during delivery, it is preferred that one radio-opaque marker 168 be provided on theinner tube 160 at theproximal end 116 of thestent 110 and another radio-opaque marker 174 be provided on thecover sheath 170 at thedistal end 118 of thestent 110. Movement of themarker 174 on thecover sheath 170 past themarker 168 on theinner tube 160 is preferably indicative of sufficient movement of thecover sheath 170 such that thestent 110 is no longer constrained by within thelumen 172 of the cover sheath has been deployed within a body lumen. - As described above in connection with FIG. 9, the preferred delivery systems according to the present invention also preferably include a
support tube 54 exterior to and coaxial with thecover sheath 70 andinner tube 60 to further assist in accurate placement of thestent 10. Thesupport tube 54 preferably extends from thehandle 50 and is sufficiently long to extend into the lumen of theguide catheter 90. As best seen in FIG. 9, thesupport tube 54 preferably extends into, e.g., a Y-connector 92 of theguide catheter 90 such that the position of thesupport tube 54 can be fixed relative to theguide catheter 90 by closure of thehemostasis valve 94 on the Y-connector 92. - It is preferred that the
support tube 54 be fixedly attached to thehandle 50 and that thesupport tube 54 be substantially inextensible along its longitudinal axis such that, after thesupport tube 54 is fixed in thehemostasis valve 94, thehandle 50 is located a fixed distance from thehemostasis valve 94. Thecover sheath 70 located within the support tube 54 (see FIG. 10) is, however, free to move longitudinally within thesupport tube 54 during deployment of thestent 10. Because thesupport tube 54 and theinner tube 60 are both fixedly attached to thehandle 50, however, the distance between thestent 10 and the hemostasis valve 94 (and handle 50) are also fixed on closure of thehemostasis valve 94 on thesupport tube 54. - Use of the delivery system described above will now be described in connection with balloon angioplasty treatment of a lesion within a coronary vessel. Deployment of the stent will typically involve balloon angioplasty to expand the passageway through a lesion. Typically, a balloon catheter will be advanced over a guidewire to the desired location. After dilatation, the balloon catheter will be withdrawn while the
guidewire 104 and guidecatheter 90 used with the balloon catheter remain in position. Theguide catheter 90 is typically sutured in position to fix its location relative to the patient. At that point, theinner tube 60 andcover sheath 70 withcompressed stent 10 will be advanced through theguide catheter 90 past thedistal end 96 of theguide catheter 90 along theguidewire 104 until thestent 10 is in the desired location relative to thelesion 102. That position can be verified by, e.g., using the radio-opaque markers inner tube 60 andcover sheath 70 as described above. - With the
stent 10 in the desired location, thehemostasis valve 94 is preferably fastened or closed on thesupport tube 54, thereby fixing the position of the stent relative to the guide catheter 90 (which, in turn fixes the position of thestent 10 relative to the patient because of the connection between theguide catheter 90 and the patient as described above). With thehemostasis valve 94 closed, therelease button 51 is moved from its locked position within thechannel 52 and then gently moved towards theproximal end 53 of thehandle 50. That movement preferably draws the distal end 76 of thecover sheath 70 past thestent 10. If thestent 10 is self-expanding, it will typically expand radially outward from theinner tube 60 towards the interior surface of thelesion 102. - After the
cover sheath 70 is withdrawn sufficiently to expose thestent 10, the balloon 80 can be inflated to either expand the stent 10 (if it is not self-expanding) or to assist in proper seating of thestent 10 against the interior surface of thelumen 100 and/orlesion 102. The balloon 80 is preferably a high pressure balloon (operating at 12-14 Bars) and preferably has an inflated diameter that is less than or equal to the interior diameter of thestent 10 as expanded. - Another feature of one preferred rapid-exchange delivery system according to the present invention is in the routing of the
guidewire 104 out of theinner tube 60 andcover sheath 70 at a point between thedistal end 61 of theinner tube 60 and the distal end of thesupport tube 54. Turning to FIG. 13, a portion of a rapid-exchange delivery system proximal from thedistal end 61 of theinner tube 60 is depicted which includes thecover sheath 70 and theinner tube 60 located within thelumen 72 of thecover sheath 70. Theguidewire lumen 64 of theinner tube 60 terminates in a first guidewire opening 63 in the depicted embodiment. A second guidewire opening 73 is provided in thecover sheath 70. - A
guide element 130 is preferably provided that extends through the second guidewire opening 73 and thefirst guidewire opening 63 and into theguidewire lumen 64 of theinner tube 60. As such, advancement of theproximal end 106 of theguidewire 104 towards the proximal end of the delivery system through the guidewire lumen 64 (to the left in FIG. 13) moves theproximal end 106 of theguidewire 104 into alumen 132 in theguide element 130. - It is preferred that only a portion of the
guidewire 104 fit within thelumen 132 in theguide element 130. As a result, continued advancement of theguidewire 104 towards the proximal end of the delivery system forces theguide element 130 out of the first andsecond guidewire openings 63/73 as well as guides theproximal end 106 of theguidewire 104 through those openings. After theproximal end 106 of theguidewire 104 is threaded through theopenings 63/73 in theinner tube 60 andcover sheath 70, the distal portion of theinner tube 60 andcover sheath 70 in which theguidewire 104 is contained can be advanced through theguide catheter 90 along theguidewire 104. - Although FIG. 13 illustrates one embodiment of a rapid-exchange delivery system, it will be understood that the stents according to the present invention can be delivered by any delivery system, e.g., an over-the-wire delivery system or by any other suitable delivery system. Furthermore, it will also be understood that the distal portions of the delivery system as depicted in FIGS. 11 and 12 could be used in connection with any suitable delivery system, including, e.g., rapid-exchange or over-the-wire delivery systems.
- Furthermore, the preceding specific embodiments are illustrative of the practice of the invention. It is to be understood, however, that other expedients known to those skilled in the art or disclosed herein, may be employed without departing from the scope of the appended claims.
Claims (44)
1. A radially expandable stent for implantation within a body lumen comprising:
an elongated generally tubular body defining a passageway having a longitudinal axis;
the body comprising a plurality of circumferential support sections arranged successively along the longitudinal axis, each of the support sections having a length along the longitudinal axis;
each of the circumferential support sections comprising a plurality of primary bends interconnected by struts, the primary bends being located on alternating ends of the support section around the circumference of the body, each of the struts connecting successive primary bends on opposite ends of the support section and having a midpoint generally located therebetween; and
at least one longitudinal member connecting adjacent support sections in the body, the longitudinal member having a first end attached proximate the midpoint of one of the struts and a second end attached proximate the midpoint of one of the struts in the adjacent support section;
wherein the stent is radially compressible into a compressed state in which the struts are generally aligned with the longitudinal axis and radially expandable into an expanded state in which the struts and the primary bends in each of the support sections are arranged in a zigzag pattern, and further wherein the longitudinal length of the stent in the compressed state is substantially the same as the longitudinal length of the stent in the expanded state.
2. A stent according to claim 1 , wherein the body comprises first, second and third support sections, and further wherein each of the longitudinal members connecting the first support section to the second support section are circumferentially offset from each of the longitudinal members connecting the second support section to the third support section.
3. A stent according to claim 1 , further comprising two or more longitudinal members connecting adjacent support sections in the body.
4. A stent according to claim 1 , wherein all of the support sections are in phase with each other.
5. A stent according to claim 1 , wherein at least one pair of adjacent support sections are out of phase with each other.
6. A stent according to claim 1 , wherein the body comprises a nickel titanium alloy.
7. A stent according to claim 1 , wherein each primary bend of the plurality of primary bends connects a pair of struts in the support section, and further wherein each pair of struts abut at a point between the primary bend and the midpoint of each of the struts in the pair of struts when the stent is in the compressed state, whereby the bending stress is reduced at each primary bend of the plurality of primary bends.
8. A stent according to claim 7 , wherein at least one of the struts in each pair of struts associated with one of the primary bends comprises a secondary bend located between the midpoint and one end of the strut, the secondary bend including an apex facing the other strut in the pair of struts, and further wherein the point at which the pair of struts abut is at the apex of the secondary bend when the stent is in the compressed state.
9. A stent according to claim 7 , wherein each strut of the plurality of struts comprises two secondary bends, one of the secondary bends located on each side of the midpoint of the strut and each of the secondary bends being spaced from the ends of the strut, each of the secondary bends having an apex, wherein the apexes of each of the secondary bends face the opposing struts in each pair of struts associated with one of the primary bends in the support section, and further wherein the point at which each pair of struts associated with one of the primary bends abut when the stent is in the compressed state is at the apexes of the secondary bends of the struts.
10. A stent according to claim 7 , wherein at least one of the struts in each pair of struts associated with one of the primary bends comprises a protrusion located between the midpoint and one end of the strut, the protrusion facing the other strut in the pair of struts, and further wherein the point at which the pair of struts abut is at the protrusion when the stent is in the compressed state.
11. A stent according to claim 7 , wherein each strut of the plurality of struts comprises two protrusions, one of the protrusions located on each side of the midpoint of the strut and each of the protrusions being spaced from the ends of the strut, wherein the protrusions face the opposing struts in each pair of struts associated with one of the primary bends in the support section, and further wherein the point at which each pair of struts abut when the stent is in the compressed state is at the protrusions in each strut in the pair of adjacent struts.
12. A self-expanding radially expandable stent for implantation within a body lumen comprising:
an elongated generally tubular body defining a passageway having a longitudinal axis, the body comprising at least one circumferential support section having a length along the longitudinal axis;
each of the circumferential support sections comprising a plurality of primary bends interconnected by struts, the primary bends being located on alternating ends of the support section around the circumference of the body, each of the struts connecting successive primary bends on opposite ends of the support section and having a midpoint generally located therebetween;
wherein the stent is radially compressible into a compressed state and radially expandable into an expanded state in which the struts and primary bends in each of the support sections are arranged in a zigzag pattern, and further wherein each pair of adjacent struts associated with each of the primary bends abut at a point between the primary bend and the midpoint of each strut in the pair of adjacent struts when the stent is in the compressed state, whereby the bending stress is reduced at each primary bend of the plurality of primary bends.
13. A stent according to claim 12 , wherein at least one of the struts in the pair of struts associated with each of the primary bends comprises a secondary bend located between the midpoint and one end of the strut, the secondary bend including an apex facing the other strut in the pair of struts, and further wherein the point at which the pair of struts abut is at the apex of the secondary bend when the stent is in the compressed state.
14. A stent according to claim 12 , wherein each strut of the plurality of struts comprises two secondary bends, one of the secondary bends located on each side of the midpoint of the strut and each of the secondary bends being spaced from the ends of the strut, each of the secondary bends having an apex, wherein the apexes of each of the secondary bends face the opposing struts in each pair of struts associated with one of the primary bends in the support section, and further wherein the point at which each pair of struts associated with one of the primary bends abut when the stent is in the compressed state is at the apexes of the secondary bends of the struts.
15. A stent according to claim 12 , wherein at least one of the struts in each pair of struts associated with one of the primary bends comprises a protrusion located between the midpoint and one end of the strut, the protrusion facing the other strut in the pair of struts, and further wherein the point at which the pair of struts abut is at the protrusion when the stent is in the compressed state.
16. A stent according to claim 12 , wherein each strut of the plurality of struts comprises two protrusions, one of the protrusions located on each side of the midpoint of the strut and each of the protrusions being spaced from the ends of the strut, wherein the protrusions face the opposing struts in each pair of struts associated with one of the primary bends in the support section, and further wherein the point at which each pair of struts associated with one of the primary bends abut when the stent is in the compressed state is at the protrusions in the struts.
17. A self-expanding radially expandable stent for implantation within a body lumen comprising:
an elongated generally tubular body defining a passageway having a longitudinal axis, the body comprising at least one circumferential support section having a length along the longitudinal axis;
each of the circumferential support sections comprising a substantially continuous element including a plurality of primary bends interconnected by struts, the primary bends being located on alternating ends of the support section around the circumference of the body, each of the struts connecting successive primary bends on opposite ends of the support section and having a midpoint generally located therebetween, wherein the stent is radially compressible into a compressed state and radially expandable into an expanded state in which the struts and primary bends in each of the support sections are arranged in a zigzag pattern; and
means for reducing bending stress at the primary bends when the stent is in the compressed state.
18. A stent according to claim 17 , wherein the means for reducing bending stress causes each pair of struts associated with one of the primary bends to abut at a point between the midpoints of the pair of struts and the primary bend.
19. A stent according to claim 17 , wherein the body comprises a plurality of circumferential support sections arranged successively along the longitudinal axis, and further wherein the body comprises at least one longitudinal member connecting adjacent support sections in the body, the longitudinal member having a first end attached to one of the support sections and a second end attached to the adjacent support section.
20. A stent according to claim 19 , wherein the first end of each of the longitudinal members is attached proximate the midpoint of one of the struts in one of the support sections and the second end of each of the longitudinal members is attached proximate the midpoint of one of the struts in an adjacent support section; wherein the longitudinal length of the stent in the compressed state is substantially the same as the longitudinal length of the stent in the expanded state.
21. A delivery system for implantation of a radially-expandable stent within a body lumen comprising:
an inner tube having a proximal end and a distal end, the inner tube having an inner tube lumen formed therein, the inner tube lumen having an opening at the distal end of the inner tube;
a cover sheath having a proximal end and a distal end, the cover sheath comprising a wall defining a cover sheath lumen, the inner tube located within the cover sheath lumen;
a stent positioned about the inner tube at the distal end of the cover sheath;
a first guidewire opening in the inner tube lumen, the first guidewire opening spaced from the distal end of the inner tube;
a second guidewire opening in the wall of the cover sheath, the second guidewire opening located proximate the first guidewire opening; and
a guide element having a distal end located within the inner tube lumen, the guide element extending between the first and second guidewire openings.
22. A system according to claim 21 , wherein the guide element comprises a proximal end located outside of the cover sheath lumen such that the guide element extends through the second guidewire opening.
23. A system according to claim 21 , wherein the guide element is removably positioned in the inner tube lumen and the first and second guidewire openings.
24. A system according to claim 21 , wherein the inner tube lumen terminates at the first guidewire opening.
25. A system according to claim 21 , wherein the first guidewire opening is formed in an inner tube wall.
26. A system according to claim 21 , wherein the guide element comprises a guide lumen formed in the distal end of the guide element.
27. A system according to claim 26 , wherein the guide lumen can receive only a portion of the guidewire.
28. A system according to claim 21 , wherein the stent is self-expanding and comprises:
an elongated generally tubular body defining a passageway having a longitudinal axis, the body comprising at least one circumferential support section having a length along the longitudinal axis;
each of the circumferential support sections comprising a plurality of primary bends interconnected by struts, the primary bends being located on alternating ends of the support section around the circumference of the body, each of the struts connecting successive primary bends on opposite ends of the support section and having a midpoint generally located therebetween;
wherein the stent is radially compressible into a compressed state and radially expandable into an expanded state in which the struts and primary bends in each of the support sections are arranged in a zigzag pattern, and further wherein each pair of adjacent struts associated with each of the primary bends abut at a point between the primary bend and the midpoint of each strut in the pair of adjacent struts when the stent is in the compressed state, whereby the bending stress is reduced at each primary bend of the plurality of primary bends.
29. A system according to claim 28 , wherein the stent is biased against the interior surface of the cover sheath in the compressed state, and further wherein the inner tube comprises a shoulder having an outside diameter greater than an inside diameter of the stent in the compressed state within the cover sheath, whereby movement of the cover sheath proximally forces the stent out of the cover sheath.
30. A system according to claim 28 , wherein at least one of the struts in the pair of struts associated with each of the primary bends comprises a secondary bend located between the midpoint and one end of the strut, the secondary bend including an apex facing the other strut in the pair of struts, and further wherein the point at which the pair of struts abut is at the apex of the secondary bend when the stent is in the compressed state.
31. A stent according to claim 28 , wherein at least one of the struts in each pair of struts associated with one of the primary bends comprises a protrusion located between the midpoint and one end of the strut, the protrusion facing the other strut in the pair of struts, and further wherein the point at which the pair of struts abut is at the protrusion when the stent is in the compressed state.
32. A stent according to claim 28 , wherein the body comprises a plurality of circumferential support sections arranged successively along the longitudinal axis, and further wherein the body comprises at least one longitudinal member connecting adjacent support sections in the body, the longitudinal member having a first end attached proximate the midpoint of one of the struts in one of the support sections and a second end attached proximate the midpoint of one of the struts in an adjacent support section; wherein the longitudinal length of the stent in the compressed state is substantially the same as the longitudinal length of the stent in the expanded state.
33. A system according to claim 32 , wherein the body of the stent comprises first, second and third support sections, and further wherein each of the longitudinal members connecting the first support section to the second support section are circumferentially offset from each of the longitudinal members connecting the second support section to the third support section.
34. A system according to claim 21 , further comprising:
an expandable balloon located on the inner tube; and
an inflation lumen in fluid communication with the balloon, the inflation lumen extending from the proximal end of the delivery system to the balloon.
35. A system according to claim 34 , wherein the balloon is located between the stent and the inner tube.
36. A method of deploying a stent within a body lumen comprising:
a) providing a radially expandable stent on a delivery system comprising:
an inner tube having a proximal end and a distal end, the inner tube having an inner tube lumen formed therein, the inner tube lumen having an opening at the distal end of the inner tube and a first guidewire opening in the inner tube lumen, the first guidewire opening spaced from the distal end of the inner tube;
a stent positioned on the exterior surface of the inner tube at the distal end of the inner tube;
a cover sheath having a proximal end and a distal end, the cover sheath comprising a wall defining a cover sheath lumen, the inner tube and stent located within the cover sheath lumen, the cover sheath further including a second guidewire opening in the wall of the cover sheath, the second guidewire opening located proximate the first guidewire opening in the inner tube; and
a guide element having a distal end located within the inner tube lumen, the guide element extending between the first and second guidewire openings, wherein the guide element comprises a guide lumen formed in the distal end of the guide element;
b) positioning a guidewire within a body lumen, wherein a proximal end of the guidewire extends out of the body lumen;
c) inserting the proximal end of the guidewire into the inner tube lumen at the distal end of the inner tube;
d) advancing the proximal end of the guidewire through the inner tube lumen towards the first guidewire opening and the distal end of the guide element, wherein at least a portion of the proximal end of the guidewire is advanced into the guide lumen in the distal end of the guide element;
e) advancing the proximal end of the guidewire through the first and second guidewire openings;
f) advancing the distal end of the inner tube and the stent over the guidewire towards the distal end of the guidewire, wherein the stent is positioned at a desired location within the body lumen; and
g) deploying the stent at the desired location within the body lumen.
37. A method according to claim 36 , wherein the guide element is removably positioned in the inner tube lumen and the first and second guidewire openings, and further wherein the step of advancing the proximal end of the guidewire through the first and second guidewire openings further comprises moving the guide element out of the first and second guidewire openings.
38. A method according to claim 36 , wherein the guide lumen can receive only a portion of the proximal end of the guidewire.
39. A method according to claim 36 , wherein the guide element comprises a proximal end located outside of the cover sheath lumen such that the guide element extends through the second guidewire opening.
40. A method of deploying a stent within a body lumen comprising:
a) providing a radially expandable stent on a delivery system comprising:
an inner tube having a proximal end and a distal end, the inner tube having an inner tube lumen formed therein;
a stent positioned on the exterior surface of the inner tube at the distal end of the inner tube;
an expandable balloon located on the inner tube;
an inflation lumen in fluid communication with the balloon, the inflation lumen extending from the proximal end of the delivery system to the balloon; and
a cover sheath having a proximal end and a distal end, the cover sheath comprising a wall defining a cover sheath lumen, the inner tube, stent, and balloon located within the cover sheath lumen;
b) positioning the inner tube, stent, balloon and cover sheath within a body lumen;
c) moving the cover sheath proximally relative to the distal end of the inner tube to deploy the stent with the body lumen; and
d) inflating the balloon within the stent.
41. A method according to claim 40 , wherein the balloon is located between the stent and the inner tube.
42. A method of deploying a stent within a body lumen comprising:
a) providing a radially expandable stent on a delivery system comprising:
an inner tube having a proximal end and a distal end;
a stent positioned on the exterior surface of the inner tube at the distal end of the inner tube;
a cover sheath having a proximal end and a distal end, the cover sheath including a cover sheath lumen, the inner tube and stent located within the cover sheath lumen; and
a support tube having a proximal end and a distal end, the support tube including a support tube lumen containing at least a portion of the proximal end of the cover sheath, the cover sheath being movable in the proximal and distal directions within the support tube lumen and the position of the inner tube being fixed relative to the position of the support tube;
b) positioning a guide catheter within a body lumen;
c) advancing the distal ends of the inner tube and the cover sheath through the guide catheter;
d) fixing the position of the support tube relative to the guide catheter, wherein the positions of the distal end of the inner tube and the stent within the body lumen are also fixed relative to the guide catheter; and
e) moving the cover sheath proximally to release the stent on the distal end of the inner tube, thereby deploying the stent within the body lumen.
43. A method according to claim 42 , wherein the guide catheter includes a hemostasis valve and further wherein the step of fixing the position of the support tube relative to the guide catheter comprises closing the hemostasis valve on the support tube.
44. A method according to claim 42 , wherein the support tube and the inner tube are fixedly attached to a handle and the cover sheath is attached to an actuator, the actuator movable relative to the handle, and further wherein the step of moving the cover sheath comprises moving the actuator relative to the handle.
Priority Applications (1)
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US10/364,612 US20030144731A1 (en) | 1998-02-05 | 2003-02-11 | Radially-expandable stent and delivery system |
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US09/019,210 US6533807B2 (en) | 1998-02-05 | 1998-02-05 | Radially-expandable stent and delivery system |
US10/364,612 US20030144731A1 (en) | 1998-02-05 | 2003-02-11 | Radially-expandable stent and delivery system |
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US09/244,968 Expired - Lifetime US6613079B1 (en) | 1998-02-05 | 1999-02-05 | Radially-expandable stent with controllable force profile |
US10/364,612 Abandoned US20030144731A1 (en) | 1998-02-05 | 2003-02-11 | Radially-expandable stent and delivery system |
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US09/244,968 Expired - Lifetime US6613079B1 (en) | 1998-02-05 | 1999-02-05 | Radially-expandable stent with controllable force profile |
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US10799352B2 (en) | 2010-02-17 | 2020-10-13 | Medtronic, Inc. | Heart valve delivery catheter with safety button |
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Also Published As
Publication number | Publication date |
---|---|
EP0971647A2 (en) | 2000-01-19 |
US20010044648A1 (en) | 2001-11-22 |
WO1999039661A2 (en) | 1999-08-12 |
US6613079B1 (en) | 2003-09-02 |
WO1999039661A3 (en) | 1999-10-28 |
US6533807B2 (en) | 2003-03-18 |
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Date | Code | Title | Description |
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STCB | Information on status: application discontinuation |
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