US20050090894A1 - Crimpable intraluminal endoprosthesis having helical elements - Google Patents
Crimpable intraluminal endoprosthesis having helical elements Download PDFInfo
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- US20050090894A1 US20050090894A1 US10/993,380 US99338004A US2005090894A1 US 20050090894 A1 US20050090894 A1 US 20050090894A1 US 99338004 A US99338004 A US 99338004A US 2005090894 A1 US2005090894 A1 US 2005090894A1
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- stent
- helical
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- expandable
- segments
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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
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- 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
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- 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
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- 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
- A61F2002/91525—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 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
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- 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
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- 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
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- 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
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- A61F2002/91541—Adjacent bands are arranged out of phase
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Definitions
- the present invention relates to intraluminal endoprosthetic devices known as stents.
- the present invention relates to stents having helical elements with a geometry that allows the stent to be readily crimped onto a delivery device.
- Stents are prosthetic devices that are implanted in the lumen of a vessel inside the body to provide support for the vessel's wall. Structural support from stents is particularly important in angioplasty procedures. Typically, stents are implanted within a vessel system to reinforce vessels that are partially occluded, collapsing, weakened, or abnormally dilated. More generally, stents can be used inside any physiological conduit or duct, including—for example—arteries, veins, bile ducts, the urinary tract, alimentary tracts, the tracheobronchial tree, a cerebral aqueduct or the genitourinary system. Stents may be used in both humans and animals.
- Self expanding stents automatically expand once they are released and assume a deployed, expanded state.
- a balloon expandable stent is expanded using an inflatable balloon catheter. The balloon is inflated to plastically deform the stent.
- Balloon expandable stents may be implanted by mounting the stent in an unexpanded or crimped state on a balloon segment of a catheter. The catheter, after having the crimped stent placed thereon, is inserted through a puncture in a vessel wall and moved through the vessel until it is positioned in the portion of the vessel that is in need of repair.
- the stent is then expanded by inflating the balloon catheter against the inside wall of the vessel. Specifically, the stent is plastically deformed by inflating the balloon so that the diameter of the stent is increased and remains at an increased state.
- the vessel in which the stent is implanted may be dilated by the stent itself when the stent is expanded.
- the Palmaz-SchatztTM stent which is disclosed in the Handbook of Coronary Stents by Patrick W. Serruys et al. (Martin Dunitz, LTD 1998), is an example of a balloon expandable stent that had been implanted in hundreds of thousands of patients.
- the Palmaz-SchatzTM stent like other known stents, has certain limitations. These include, but are not limited to: (i) low stent-to-vessel ratio uniformity, (ii) comparative rigidity of the stent in a crimped as well as deployed state, and (iii) limited flexibility making delivery and placement in narrow vessels difficult.
- Stent-to-vessel ratio generally refers to the degree that the vessel wall is supported by the stent in its expanded state and preferably should be uniform throughout the length of the stent. Furthermore because the Palmaz-SchatzTM stent consists of one or more bridges that connect a number of consecutively slotted tubes, there are a number of bare areas in the vessel after the expansion of the stent. These shortfalls are common to many stents. Id. at 36.
- the present invention is directed to expandable stents that have geometries that allow them to be readily crimped onto a balloon delivery device.
- the stent may be comprised of a plurality of first helical segment having a first helical angle with respect to the longitudinal axis of the stent and a plurality of second helical segments that have a second helical angle.
- the helical segments are capable of expanding and contracting circumferentially, i.e., they expand or contract along the circumference of the stent.
- at least one portion of one first helical segment, along with at least one portion of a second first helical element nestle between the same two portions of two separate second helical segments.
- the stent is comprised of a plurality of first expandable elements and a plurality of second expandable elements.
- the first expandable element may have a segment that nests within another segment of the same first expandable element.
- the first expandable elements are joined together by struts to form first helical segments and the second expandable elements are joined together by struts to form second helical segments.
- the first and second helical segments may have different helical angles or different pitches.
- the first and second helical segments share common struts.
- the stent may be comprised of a plurality of cells.
- Each cells may be comprised of first and second elements that are alternatively joined together (i.e., each first element is joined to two second elements and each second element is joined to two first elements to form a polygon).
- the polygon may be amorphous or may have a definite shape.
- the first and second elements may touch each other when the stent is crimped.
- a plurality of struts joins the cells to form a stent body.
- portions of a first element may nest within other portions of the same first element and a portion of a second element may also nest within a portion of the same first element.
- FIG. 1 is a three dimensional view of one embodiment of a stent according to the present invention.
- FIG. 2 is planar view of a flattened portion of the circumference of the stent in FIG. 1 .
- FIG. 3 is a planar view of one element that makes us the stent body as shown in the planar view of FIG. 2 .
- FIGS. 4 a and 4 b are views of filament segments that comprise the element shown in FIG. 3 .
- FIG. 5 is a planar view of a second element that makes up the stent body shown in FIG. 2 .
- FIG. 6 is a planar view of the element of FIG. 3 , when the stent is crimped.
- FIG. 7 is a planar view of the elements of FIGS. 3 and 5 , when the stent is crimped.
- FIG. 8 a is a planar view illustrating a plurality of cells that may be joined together to make one embodiment of the stent of the present invention.
- FIG. 8 b is an enlarged portion of one of the cells shown in FIG. 8 a.
- FIG. 9 is a planar view of the cell of FIG. 8 a after the stent has been crimped.
- FIG. 10 illustrates how certain first elements and certain second elements nestle when the stent is crimped.
- the present invention is directed to an expandable stent having a geometry that is well-suited for crimping the stent onto a delivery device.
- the stents may have an expanded diameter that is 3 to 6 times that of its crimped diameter.
- the stent-to-vessel ratios may be better than 15%.
- a stent is comprised of a main body section 100 having a longitudinal axis 1000 .
- the stent shown in FIG. 1 is mounted on a carrier 616 .
- the main body is comprised of a plurality of first helical segments 120 a and 120 b and a plurality of second helical segments 150 a and 150 b .
- the first helical segments form a helical angle ⁇ with respect to the longitudinal axis 1000 of the stent, resulting in the first helical segments having a first pitch.
- the second helical segments 150 a and 150 b form a helical angle ⁇ with respect to the longitudinal axis 1000 , resulting in the second helical segments having a second pitch.
- a varies between 20° and 50°
- ⁇ varies between 20° and 90°.
- the first helical segments 120 a and 120 b and second helical segments 150 a and 150 b are circumferentially expandable, i.e., they are capable of expanding in a direction parallel to the direction of the circumference 200 of the stent.
- the helical segments 120 a , 120 b , 150 a , and 150 b also circumferentially contract when the stent is crimped.
- the first helical segments 120 a and 120 b may be comprised of a plurality of filament segments and likewise the second helical segments 150 a and 150 b may be comprised of a plurality of filament segments.
- the total length of the sum of all the filament segments comprising the first helical segment may be longer than the total length of the filament segments comprising the second helical segment.
- the first and second helical segments may share common filament segments.
- the first helical segments 120 a and 120 b are comprised of a plurality of first expandable elements 300
- the second helical segments are comprised of a plurality of second expandable elements 350
- Two or more first expandable segments 300 are joined together by a plurality of struts 400 to form each of the first helical segments 120 a and 120 b
- the same struts 400 also join two second expandable segments 350 to form the second helical segments 150 a and 150 b
- the struts 400 may be an integral part of the first or second expandable element, or both.
- the first expandable elements 300 are comprised of a plurality of contiguous filament segments 700 a , 700 b , 710 a , 710 b and 720 .
- the filament segments 700 a , 710 a and 720 are joined together to form a generally R-shaped structure 730 .
- the filament that forms the head of the R i.e. filament 710 a or 710 b
- the radius r may take many values, including but not limited to approximately 0.015 inches.
- the first expandable elements 300 may be comprised of a plurality of R-shaped structures 730 a and 730 b oriented inversely to one another and sharing a common filament segment 720 .
- the second expandable elements 350 may be comprised of a plurality of contiguous filament segments 770 a , 770 b , 775 a , 780 , and 775 b and may, for example, in some embodiments form a Z-shaped structure.
- filament 770 a may lie at an angle ⁇ with respect to filament 780 and segments 770 a and 770 b may be joined to the single segment 780 by curved segments 775 a and 775 b .
- 770 a and 770 b have the same dimensions, and 780 may be shorter.
- the angle ⁇ may also vary greatly, and in one embodiment ranges between 30° and 40°, for example.
- some embodiments of the present invention may have endzones 600 & 610 that straddle the main body 100 .
- the endzones may have square outer edges 605 & 615 .
- the endzones may be attached to the main body 100 with a plurality of second struts 450 . (See FIG. 2 ).
- the second struts may have an orientation that differs from that of the other struts 400 .
- the second struts 450 may be parallel to the cylindrical axis 1000 of the stent, while the struts 400 may be oriented at an angle to the cylindrical axis of the stent.
- the stents of the present invention provide a geometry that improves their crimpability.
- one embodiment of the present invention may have a crimped diameter of less than 2.0 mm and an expanded diameter of 6.0-12.0 mm, or greater.
- the stent may be crimped onto a PTA Balloon at a diameter of 1.50 mm and it may be manufactured from a tube having a diameter of approximately 0.030 to 0.500 inches.
- PTA Balloon at a diameter of 1.50 mm and it may be manufactured from a tube having a diameter of approximately 0.030 to 0.500 inches.
- other sized tube may be used.
- stents may be manufactured in a wide variety of sizes for a wide variety of applications.
- a first portion of the first expandable element 300 nests within another portion of the same first expandable element 300 .
- portions of filament 710 a and 720 nest within a concave portion of filament 700 b .
- portions of filaments 710 b and 720 nest within a concave portion of filament 700 a.
- a portion of a second expandable element 350 nests within a portion of the first expandable element 300 .
- a portion of second expandable element 350 nests within a portion of element 300 .
- a portion of filament 770 b and 775 b nest within the concave portions of filament 710 a and 700 a . This example illustrates some, but not necessarily all, of the nesting features of the present invention
- portions from two separate first expandable elements 300 may nestle between the same portions of two separate second expandable segments 350 .
- part of one first expandable element namely filament 710 a and part of a second first expandable element 710 b , both of which comprise heads for R-shaped structures 730 a and 730 b (see also FIGS. 4 a and 4 b ) nestle between filaments 775 a and 775 b , which are each part of a separate second expandable elements 350 .
- FIG. 10 illustrates some, but not necessarily all, of the nestling features of the geometry of the present invention.
- filament 775 a part of one second expandable element 350 which is in turn part of a second helical segment 150 a
- filament 710 a is part of one first expandable segment 300 which is in turn part of a first helical segment 120 a
- filament 775 b is part of different second expandable element 350 , which is part of a second second helical segment 150 b
- filament 710 b is part of a second first expandable element 300 , which is in turn part of another helical segment 120 b .
- portions of one first helical segment and portions of another first helical segment nestle, when the stent is crimped, between portions of two separate second helical segments.
- the stent of the present invention may in some embodiments, be comprised of a plurality of cells 500 .
- the cells 500 may be joined together by struts 400 .
- Each cell 500 may be comprised of first elements 300 and second elements 350 .
- each first element 300 is joined to two second elements 350
- each second element 350 is joined to two first elements 300 .
- cells may be joined together so that the resulting stent has a plurality of helical segments, wherein at least one helical segment cross another. (See e.g. FIG. 2 ).
- Cell geometry may be such that each cell expands at a relatively constant rate.
- each cell is comprised of a plurality of first expandable elements 300 and a plurality of second expandable elements 350 .
- Each first element 300 is in turn comprised of a plurality of R-shaped elements 730 a and 730 b .
- the second expandable elements 350 in this illustrative embodiment are generally Z-shaped.
- the R-shaped elements 730 a and 730 b expand at a slower initial rate than the Z shaped elements.
- each cell circumferentially contracts.
- a first expandable element e.g. at least portions of filaments 710 a and 720
- another portion of the same first expandable element e.g. at least portions of filament 700 b
- portions of two separate first expandable elements 300 e.g., filaments 710 a and 710 b
- each cell expands uniformly along line 200 , which is the circumferential dimension of the stent. (See FIG. 1 ).
- the second expandable elements 350 open at a faster rate than the first expandable elements 300 , but since the first expandable elements are oriented diagonally, as are the second expandable elements, the right portion 2000 of the cell 500 expands at the same rate as the left portion 3000 of the cell 500 . (See FIG. 9 ).
- first elements 300 and the second elements 350 may take numerous forms and shapes other than those shown. This may result in a first helical segment having a total filament length that is greater than or less than that of a second helical element.
- the stents of the present invention may be manufactured from materials with techniques that are readily known in the art, such as for example, by laser cutting tubes, which are manufactured from appropriate stent materials.
- the stent of the present invention may be comprised of a single continuous piece of material or it may be comprised of multiple disparate filaments or segment pieces joined together by well-known techniques.
Abstract
A stent having helical elements, a geometry for improved crimping, and a good stent-to-vessel ratio is disclosed. In one embodiment, the stent has a plurality of first helical segments and a plurality of second opposing helical segments. The first helical segments are comprised of a plurality of first expandable elements and the second helical segments are comprised of a plurality of second helical elements. The expandable elements are joined to each other by a plurality of struts. When the stent is crimped a portion of one of the first expandable elements nest within another portion of the same expandable element and a portion of two first expandable elements nestle between the same two portions of second expandable elements.
Description
- This application claims the benefit of U.S. Provisional Application No. 60/267,778, filed on Feb. 9, 2001, which is hereby incorporated in its entirety by reference, and it is a continuation-in-part of U.S. patent application Ser. No. 09/511,481, filed on Feb. 23, 2000, which is also hereby incorporated in its entirety by reference and which is a continuation of U.S. patent application Ser. No. 09/094,402, filed Jun. 10, 1998 (now U.S. Pat. No. 6,117,165).
- 1. Field of the Invention
- The present invention relates to intraluminal endoprosthetic devices known as stents. In particular, the present invention relates to stents having helical elements with a geometry that allows the stent to be readily crimped onto a delivery device.
- 2. Description of Related Art
- Stents are prosthetic devices that are implanted in the lumen of a vessel inside the body to provide support for the vessel's wall. Structural support from stents is particularly important in angioplasty procedures. Typically, stents are implanted within a vessel system to reinforce vessels that are partially occluded, collapsing, weakened, or abnormally dilated. More generally, stents can be used inside any physiological conduit or duct, including—for example—arteries, veins, bile ducts, the urinary tract, alimentary tracts, the tracheobronchial tree, a cerebral aqueduct or the genitourinary system. Stents may be used in both humans and animals.
- There are typically two types of stents: self expanding stents and balloon expandable stents. Self expanding stents automatically expand once they are released and assume a deployed, expanded state. A balloon expandable stent is expanded using an inflatable balloon catheter. The balloon is inflated to plastically deform the stent. Balloon expandable stents may be implanted by mounting the stent in an unexpanded or crimped state on a balloon segment of a catheter. The catheter, after having the crimped stent placed thereon, is inserted through a puncture in a vessel wall and moved through the vessel until it is positioned in the portion of the vessel that is in need of repair. The stent is then expanded by inflating the balloon catheter against the inside wall of the vessel. Specifically, the stent is plastically deformed by inflating the balloon so that the diameter of the stent is increased and remains at an increased state. In some situations, the vessel in which the stent is implanted may be dilated by the stent itself when the stent is expanded.
- The Palmaz-Schatzt™ stent, which is disclosed in the Handbook of Coronary Stents by Patrick W. Serruys et al. (Martin Dunitz, LTD 1998), is an example of a balloon expandable stent that had been implanted in hundreds of thousands of patients. The Palmaz-Schatz™ stent, like other known stents, has certain limitations. These include, but are not limited to: (i) low stent-to-vessel ratio uniformity, (ii) comparative rigidity of the stent in a crimped as well as deployed state, and (iii) limited flexibility making delivery and placement in narrow vessels difficult. Stent-to-vessel ratio generally refers to the degree that the vessel wall is supported by the stent in its expanded state and preferably should be uniform throughout the length of the stent. Furthermore because the Palmaz-Schatz™ stent consists of one or more bridges that connect a number of consecutively slotted tubes, there are a number of bare areas in the vessel after the expansion of the stent. These shortfalls are common to many stents. Id. at 36.
- The present invention is directed to expandable stents that have geometries that allow them to be readily crimped onto a balloon delivery device. In one embodiment, the stent may be comprised of a plurality of first helical segment having a first helical angle with respect to the longitudinal axis of the stent and a plurality of second helical segments that have a second helical angle. The helical segments are capable of expanding and contracting circumferentially, i.e., they expand or contract along the circumference of the stent. In this embodiment, when the stent is crimped, at least one portion of one first helical segment, along with at least one portion of a second first helical element, nestle between the same two portions of two separate second helical segments.
- In one embodiment of the present invention, the stent is comprised of a plurality of first expandable elements and a plurality of second expandable elements. The first expandable element may have a segment that nests within another segment of the same first expandable element. In some embodiments, the first expandable elements are joined together by struts to form first helical segments and the second expandable elements are joined together by struts to form second helical segments. The first and second helical segments may have different helical angles or different pitches. In some embodiments, the first and second helical segments share common struts.
- In some embodiments of the present invention, the stent may be comprised of a plurality of cells. Each cells may be comprised of first and second elements that are alternatively joined together (i.e., each first element is joined to two second elements and each second element is joined to two first elements to form a polygon). The polygon may be amorphous or may have a definite shape. When the stent is crimped a portion of each first of the elements that make up the cell nestles between portions of the second elements of the cell. In some embodiments, the first and second elements may touch each other when the stent is crimped. A plurality of struts joins the cells to form a stent body. In addition portions of a first element may nest within other portions of the same first element and a portion of a second element may also nest within a portion of the same first element.
-
FIG. 1 is a three dimensional view of one embodiment of a stent according to the present invention. -
FIG. 2 is planar view of a flattened portion of the circumference of the stent inFIG. 1 . -
FIG. 3 is a planar view of one element that makes us the stent body as shown in the planar view ofFIG. 2 . -
FIGS. 4 a and 4 b are views of filament segments that comprise the element shown inFIG. 3 . -
FIG. 5 is a planar view of a second element that makes up the stent body shown inFIG. 2 . -
FIG. 6 is a planar view of the element ofFIG. 3 , when the stent is crimped. -
FIG. 7 is a planar view of the elements ofFIGS. 3 and 5 , when the stent is crimped. -
FIG. 8 a is a planar view illustrating a plurality of cells that may be joined together to make one embodiment of the stent of the present invention. -
FIG. 8 b is an enlarged portion of one of the cells shown inFIG. 8 a. -
FIG. 9 is a planar view of the cell ofFIG. 8 a after the stent has been crimped. -
FIG. 10 illustrates how certain first elements and certain second elements nestle when the stent is crimped. - The present invention is directed to an expandable stent having a geometry that is well-suited for crimping the stent onto a delivery device. In some, but not necessarily all embodiments of the present invention, the stents may have an expanded diameter that is 3 to 6 times that of its crimped diameter. In addition, in some—but not necessarily all—embodiments the stent-to-vessel ratios may be better than 15%.
- In one embodiment of the present invention, as is shown in
FIGS. 1 & 2 , a stent is comprised of amain body section 100 having alongitudinal axis 1000. The stent shown inFIG. 1 is mounted on acarrier 616. The main body is comprised of a plurality of firsthelical segments helical segments longitudinal axis 1000 of the stent, resulting in the first helical segments having a first pitch. The secondhelical segments longitudinal axis 1000, resulting in the second helical segments having a second pitch. In some embodiments a varies between 20° and 50°, and θ varies between 20° and 90°. The firsthelical segments helical segments circumference 200 of the stent. Thehelical segments - As is discussed further below, in some embodiments, the first
helical segments helical segments - As is shown in
FIG. 2 , the firsthelical segments expandable elements 300, and the second helical segments are comprised of a plurality of secondexpandable elements 350. Two or more firstexpandable segments 300 are joined together by a plurality ofstruts 400 to form each of the firsthelical segments same struts 400 also join two secondexpandable segments 350 to form the secondhelical segments struts 400 may be an integral part of the first or second expandable element, or both. - As is shown in
FIG. 3 , in some embodiments, the firstexpandable elements 300 are comprised of a plurality ofcontiguous filament segments filament segments FIG. 4 ). The filament that forms the head of the R, i.e. filament 710 a or 710 b, may be curved and have a radius r. The radius r may take many values, including but not limited to approximately 0.015 inches. As is shown inFIGS. 3, 4 a, and 4 b, the firstexpandable elements 300 may be comprised of a plurality of R-shapedstructures 730 a and 730 b oriented inversely to one another and sharing acommon filament segment 720. - In some embodiments, as is shown in
FIG. 5 , the secondexpandable elements 350 may be comprised of a plurality ofcontiguous filament segments filament 770 a may lie at an angle β with respect tofilament 780 andsegments single segment 780 bycurved segments - As is shown in
FIG. 1 , some embodiments of the present invention may haveendzones 600 & 610 that straddle themain body 100. The endzones may have squareouter edges 605 & 615. The endzones may be attached to themain body 100 with a plurality ofsecond struts 450. (SeeFIG. 2 ). The second struts may have an orientation that differs from that of theother struts 400. For example, thesecond struts 450 may be parallel to thecylindrical axis 1000 of the stent, while thestruts 400 may be oriented at an angle to the cylindrical axis of the stent. - The stents of the present invention provide a geometry that improves their crimpability. For example, one embodiment of the present invention may have a crimped diameter of less than 2.0 mm and an expanded diameter of 6.0-12.0 mm, or greater. The stent may be crimped onto a PTA Balloon at a diameter of 1.50 mm and it may be manufactured from a tube having a diameter of approximately 0.030 to 0.500 inches. Of course, other sized tube may be used. And stents may be manufactured in a wide variety of sizes for a wide variety of applications.
- In one embodiment of the present invention, when the stent is crimped, a first portion of the first
expandable element 300 nests within another portion of the same firstexpandable element 300. For example, as is shown inFIG. 6 , portions offilament filament 700 b. Likewise portions offilaments filament 700 a. - In some embodiments of the present invention, when the stent is crimped, a portion of a second
expandable element 350 nests within a portion of the firstexpandable element 300. For example, as is shown inFIG. 7 , a portion of secondexpandable element 350 nests within a portion ofelement 300. Specifically, in this embodiment, which is illustrative and not exhaustive of the present invention, a portion offilament filament - In some embodiments of the present invention, when the stent is crimped, portions from two separate first
expandable elements 300 may nestle between the same portions of two separate secondexpandable segments 350. As is shown inFIG. 10 , part of one first expandable element, namely filament 710 a and part of a second firstexpandable element 710 b, both of which comprise heads for R-shapedstructures 730 a and 730 b (see alsoFIGS. 4 a and 4 b) nestle betweenfilaments expandable elements 350.FIG. 10 illustrates some, but not necessarily all, of the nestling features of the geometry of the present invention. - As is illustrated by
FIGS. 10, 3 , 4 a, 3 b, and 3, in some embodiments, not only is thefilament 775 a part of one secondexpandable element 350 which is in turn part of a secondhelical segment 150 a, but also filament 710 a is part of one firstexpandable segment 300 which is in turn part of a firsthelical segment 120 a. Likewise,filament 775 b is part of different secondexpandable element 350, which is part of a second secondhelical segment 150 b andfilament 710 b is part of a second firstexpandable element 300, which is in turn part of anotherhelical segment 120 b. Thus, in one embodiment of the present invention portions of one first helical segment and portions of another first helical segment nestle, when the stent is crimped, between portions of two separate second helical segments. - As is shown in
FIG. 8 a, the stent of the present invention, may in some embodiments, be comprised of a plurality ofcells 500. In some embodiments, thecells 500 may be joined together bystruts 400. Eachcell 500 may be comprised offirst elements 300 andsecond elements 350. In one embodiment, as is shown inFIG. 8 b, eachfirst element 300 is joined to twosecond elements 350, and eachsecond element 350 is joined to twofirst elements 300. This results in a polygon, which may take many forms or may be amorphous. As is shown inFIGS. 2 and 8 a, cells may be joined together so that the resulting stent has a plurality of helical segments, wherein at least one helical segment cross another. (See e.g.FIG. 2 ). - Cell geometry may be such that each cell expands at a relatively constant rate. For example, in the embodiment shown in
FIG. 8 a, each cell is comprised of a plurality of firstexpandable elements 300 and a plurality of secondexpandable elements 350. Eachfirst element 300 is in turn comprised of a plurality of R-shapedelements 730 a and 730 b. The secondexpandable elements 350 in this illustrative embodiment are generally Z-shaped. During expansion, the R-shapedelements 730 a and 730 b expand at a slower initial rate than the Z shaped elements. By staggering or alternating circumferentiallyfirst elements 300 andsecond elements 350, the stent expands circumferentially in a uniform manner because each cell circumferentially expands uniformly, not withstanding that theelements 350 expand faster than theelements 300. - As is shown in
FIG. 9 , when a stent according to the present invention is crimped, each cell circumferentially contracts. In this embodiment, which is included herein for illustrative purposes only and is not exhaustive of the present invention, when the stent is crimped, one portion of a first expandable element (e.g. at least portions offilaments 710 a and 720) nests within another portion of the same first expandable element (e.g. at least portions offilament 700 b) and portions of two separate first expandable elements 300 (e.g.,filaments expandable elements 350. When the stent is expanded each cell expands uniformly alongline 200, which is the circumferential dimension of the stent. (SeeFIG. 1 ). The secondexpandable elements 350 open at a faster rate than the firstexpandable elements 300, but since the first expandable elements are oriented diagonally, as are the second expandable elements, theright portion 2000 of thecell 500 expands at the same rate as theleft portion 3000 of thecell 500. (SeeFIG. 9 ). - The foregoing embodiments and description is intended to illustrate the various and broad-ranging features of the present invention and is not intended to limit the scope or spirit of the present invention. The present invention may be embodied in numerous forms other than those specifically described above. For example, and without limitation, the
first elements 300 and thesecond elements 350 may take numerous forms and shapes other than those shown. This may result in a first helical segment having a total filament length that is greater than or less than that of a second helical element. In addition, the stents of the present invention may be manufactured from materials with techniques that are readily known in the art, such as for example, by laser cutting tubes, which are manufactured from appropriate stent materials. Thus, although the embodiments described herein refer to different elements and segments within the same stent, those skilled in the art will recognize that the stent of the present invention may be comprised of a single continuous piece of material or it may be comprised of multiple disparate filaments or segment pieces joined together by well-known techniques.
Claims (7)
1-16. (canceled)
17. A stent having a generally cylindrical main body, the main body comprising:
a plurality of helical segments, at least one helical segment crossing another helical segment; and
wherein the stent has a crimped diameter and an expanded diameter that is 3-6 times the crimped diameter.
18. The stent of claim 17 , wherein the helical segments contract and expand in a direction parallel to the circumference of the main body when the stent is crimped and expanded.
19-20. (canceled)
21. The stent of claim 18 , wherein at least a portion of one helical segment nestles between two other helical segments when the stent is crimped and the stent is manufactured from a tube having a diameter of approximately between 0.03 to 0.500 inches.
22. The stent of claim 21 , wherein the stent is manufactured by laser cutting the tube.
23-37. (canceled)
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US12/727,567 Expired - Fee Related US8372135B2 (en) | 1997-06-13 | 2010-03-19 | Stent having helical elements |
US12/878,341 Expired - Fee Related US7942922B2 (en) | 1997-06-13 | 2010-09-09 | Stent having helical elements |
US12/878,232 Expired - Fee Related US7967852B2 (en) | 1997-06-13 | 2010-09-09 | Stent having helical elements |
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EP (1) | EP0884029B1 (en) |
JP (2) | JP4704528B2 (en) |
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