US20100269950A1 - Apparatus and Method for Forming a Wave Form for a Stent From a Wire - Google Patents

Apparatus and Method for Forming a Wave Form for a Stent From a Wire Download PDF

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Publication number
US20100269950A1
US20100269950A1 US12/428,581 US42858109A US2010269950A1 US 20100269950 A1 US20100269950 A1 US 20100269950A1 US 42858109 A US42858109 A US 42858109A US 2010269950 A1 US2010269950 A1 US 2010269950A1
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United States
Prior art keywords
wire
forming member
forming
axis
substantially parallel
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Abandoned
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US12/428,581
Inventor
Mark Hoff
Daniel Moore
Michael Craven
Gianfranco Pellegrini
Erik Griswold
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Medtronic Vascular Inc
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Medtronic Vascular Inc
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Publication date
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Priority to US12/428,581 priority Critical patent/US20100269950A1/en
Assigned to MEDTRONIC VASCULAR, INC. reassignment MEDTRONIC VASCULAR, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CRAVEN, MICHAEL, HOFF, MARK, MOORE, DANIEL, GRISWOLD, ERIK, PELLEGRINI, GIANFRANCO
Publication of US20100269950A1 publication Critical patent/US20100269950A1/en
Abandoned legal-status Critical Current

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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B21MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21FWORKING OR PROCESSING OF METAL WIRE
    • B21F1/00Bending wire other than coiling; Straightening wire
    • B21F1/04Undulating
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B21MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21FWORKING OR PROCESSING OF METAL WIRE
    • B21F45/00Wire-working in the manufacture of other particular articles
    • B21F45/008Wire-working in the manufacture of other particular articles of medical instruments, e.g. stents, corneal rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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

Definitions

  • the present invention is generally related to an apparatus and method for forming a wave form for a stent. More particularly, the present invention is related to an apparatus and method for forming the wave form from a wire.
  • a stent is typically a hollow, generally cylindrical device that is deployed in a body lumen from a radially contracted configuration into a radially expanded configuration, which allows it to contact and support a vessel wall.
  • a plastically deformable stent can be implanted during an angioplasty procedure by using a balloon catheter bearing a compressed or “crimped” stent, which has been loaded onto the balloon. The stent radially expands as the balloon is inflated, forcing the stent into contact with the body lumen, thereby forming a support for the vessel wall. Deployment is effected after the stent has been introduced percutaneously, transported transluminally, and positioned at a desired location by means of the balloon catheter.
  • Stents may be formed from wire(s), may be cut from a tube, or may be cut from a sheet of material and then rolled into a tube-like structure. While some stents may include a plurality of connected rings that are substantially parallel to each other and are oriented substantially perpendicular to a longitudinal axis of the stent, others may include a helical coil that is wrapped around the longitudinal axis at a non-perpendicular angle.
  • a stent that includes a helical coil may be formed from a single wire that includes a wave form that is configured to allow the stent to radially expand.
  • it may be difficult to form a stent from a single wire while controlling the wave form so that the end result is a stent that expands uniformly along its length.
  • Embodiments of the present invention describe an apparatus and method for forming a wave form for a stent from a single wire.
  • an apparatus for forming a wave form for a stent from a wire includes a first forming member configured to move substantially parallel to a first axis and to move substantially parallel to a second axis that is orthogonal to the first axis, and a second forming member configured to move substantially parallel to the first axis and to move substantially parallel to the second axis.
  • the second forming member is positioned opposite from the first forming member relative to the second axis along which the wire is configured to travel.
  • the apparatus includes a controller configured to control movement of the first forming member relative to the wire and to control movement of the second forming member relative to the wire so that the first forming member and the second forming member deform the wire in opposite directions to form a portion of the wave form.
  • a method for forming a wave form for a stent from a wire includes deforming the wire by moving a first forming member in a first direction substantially perpendicular to a wire axis defined by the wire prior to being deformed, and deforming the wire by moving a second forming member located on a first side of the first forming member in a second direction that is substantially opposite to the first direction.
  • the method includes moving the first forming member away from the wire, moving the first forming member in a third direction substantially parallel to the wire axis to a position on an opposite side of the second forming member, and deforming the wire by moving the first forming member in the first direction.
  • an apparatus for forming a wave form for a stent from a wire includes a plurality of first forming members spaced apart from one another along a wire axis. Each first forming member is configured to move substantially parallel to the wire axis and to move substantially parallel to a second axis that is orthogonal to the wire axis.
  • the apparatus also includes a plurality of second forming members spaced apart from one another along the wire axis so that at least one of the second forming members is in between two of the first forming members along the wire axis.
  • Each second forming member is configured to move substantially parallel to the wire axis and to move substantially parallel to the second axis.
  • the apparatus includes a controller configured to control movement of the first forming members and movement of the second forming members so that the first forming members and the second forming members deform the wire in opposite directions to form a portion of the wave form.
  • a method for forming a stent from a wire includes deforming the wire with a plurality of first forming members by moving the first forming members in a first direction, deforming the wire with a plurality of second forming members by moving the second forming members in a second direction that is substantially opposite the first direction, and moving the first forming members and the second forming members in a third direction that is substantially orthogonal to the first and second directions.
  • the method includes moving the first forming members away from the wire in the second direction, moving the second forming members away from the wire in the first direction, and advancing the wire in the third direction.
  • FIG. 1 is a schematic view of an apparatus for forming a wave form for a stent from a wire when the wire is first fed into the apparatus, and a first forming member and a second forming member are in home positions;
  • FIG. 2 is a schematic view of the apparatus of FIG. 1 when the first forming member engages and deforms the wire;
  • FIG. 3 is a schematic view of the apparatus of FIG. 2 when the second forming member engages and deforms the wire;
  • FIG. 4 is a schematic view of the apparatus of FIG. 3 when the second forming member moves away from the wire;
  • FIG. 5 is a schematic view of the apparatus of FIG. 4 when the second forming member moves in a direction substantially parallel to the wire;
  • FIG. 6 is a schematic view of the apparatus of FIG. 5 when the second forming member engages and deforms the wire;
  • FIG. 7 is a schematic view of the apparatus of FIG. 6 when the first forming member disengages the wire;
  • FIG. 8 is a schematic view of the apparatus of FIG. 7 when the first forming member moves in the direction substantially parallel to the wire;
  • FIG. 9 is a schematic view of the apparatus of FIG. 8 when the first forming member engages and deforms the wire;
  • FIG. 10 is a schematic view of the apparatus of FIG. 9 when the first forming member and the second forming member disengage the wire;
  • FIG. 11 is a schematic view of the apparatus of FIG. 10 when the wire is moved relative to the apparatus and the first forming member and the second forming member return to their respective home positions;
  • FIG. 12 is a schematic view of the apparatus of FIG. 11 when the first forming member engages and deforms the wire;
  • FIG. 13 is a schematic view of a first waveform produced with the apparatus of FIGS. 1-12 ;
  • FIG. 14 is a schematic view of a second waveform produced with the apparatus of FIGS. 1-12 ;
  • FIG. 15 is a schematic view of another embodiment of an apparatus for forming a wave form for a stent from a wire when the wire is first fed into the apparatus, and a plurality of first forming members and a plurality of second forming members are in their respective home positions;
  • FIG. 16 is a schematic view of the apparatus of FIG. 15 when the first forming members and the second forming members engage and deform the wire to form the wave form;
  • FIG. 17 is a schematic view of the apparatus of FIG. 15 when the first forming members and the second forming members disengage and move away from the wire;
  • FIG. 18 is a schematic view of the apparatus of FIG. 15 when the wire is moves relative to the apparatus, and the first forming members and the second forming members return to their respective home positions;
  • FIG. 19 is a schematic block diagram that illustrates communication between a controller and other parts of the apparatus of FIGS. 1-12 ;
  • FIG. 20 is a schematic block diagram that illustrates communication between a controller and other parts of the apparatus of FIGS. 15-18 .
  • FIG. 1 schematically illustrates a portion of an apparatus 10 for forming a wave form for a stent from a wire 12 .
  • a supply 14 of the wire 12 is provided to the apparatus 10 .
  • the supply 14 may include a spool upon which the wire 12 is wound.
  • the wire 12 may have any suitable diameter for the intended stent application.
  • the wire 12 may have a diameter between about 0.0025′′ and about 0.0050′′.
  • the supply 14 may be mounted outside of the apparatus 10 or within the apparatus 10 so that the wire 12 may be fed in a first direction 1D into a wire forming area 16 of the apparatus 10 via an inlet 15 .
  • the wire 12 extends through the wire forming area 16 substantially along an axis, and exits the wire forming area 16 via an outlet 17 .
  • a suitable clamp 18 may be located just outside the wire forming area 16 , as illustrated, or may be located within the wire forming area 16 .
  • the illustrated embodiment is not intended to be limiting in any way.
  • the clamp 18 is configured to clamp the wire 12 so that tension may be applied to the wire 12 as the wire 12 is formed into a predetermined shape, as discussed in further detail below.
  • the apparatus 10 also includes a first forming member 20 and a second forming member 22 , each of which being located within the wire forming area 16 .
  • the first forming member 20 is located on one side of the wire 12 and the second forming member 22 is located on an opposite side of the wire 12 as compared to the first forming member 20 .
  • the first forming member 20 and the second forming member 22 each have a substantially elongated shape, similar to a finger, that is oriented substantially perpendicular to a (longitudinal) wire axis that is defined by the wire 12 , as illustrated.
  • the first forming member 20 includes a wire engaging surface 24 that is configured to engage the wire 12 when the first forming member 20 is moved in a second direction 2D that is substantially orthogonal to the first direction 1D. After the wire engaging surface 24 has engaged the wire 12 , the first forming member 20 continues to move in the second direction 2D to deform the wire 12 , as shown in FIG. 2 . When the desired deformation is obtained, movement of the first forming member 20 in the second direction 2D is stopped and the wire 12 is held in place by the first forming member 20 , as well as the clamp 18 .
  • the wire engaging surface 24 of the first forming member 20 is illustrated as having a triangular configuration, such a configuration is shown for schematic purposes. For example, the wire engaging surface 24 may be more rounded and may have a tip that has a radius that is substantially the same as the inner radius of the desired shape of the deformed wire. The illustrated embodiment is not intended to be limiting in any way.
  • the first forming member 20 may be moved in the second direction 2D by a first actuator 26 , which may be configured to move in the first direction 1D along a suitable structure, such as a rail 28 .
  • a first actuator 26 may be in communication with a controller 30 (as shown in FIG. 19 ) that is programmed to determine the X-Y position of the first forming member 20 relative to the wire 12 at any given time.
  • the controller 30 is configured to signal the first actuator 26 to move the first forming member 20 to the desired coordinates within the wire forming area 16 , as discussed in further detail below.
  • the second forming member 22 includes a wire engaging surface 34 that is configured to engage the wire 12 when the second forming member 22 is moved in a third direction 3D that is substantially opposite to the second direction 2D and orthogonal to the first direction 1D.
  • the second forming member 22 continues to move in the third direction 3D to deform the wire 12 , as shown in FIG. 3 .
  • movement of the second forming member 22 in the third direction 3D is stopped and the wire 12 is momentarily held in place by both the first forming member 20 and the second forming member 22 .
  • the wire engaging surface 34 of the second forming member 22 is illustrated as having a triangular configuration, such a configuration is shown for schematic purposes.
  • the wire engaging surface 34 may be more rounded and may have a tip that has a radius that is substantially the same as the inner radius of the desired shape of the deformed wire.
  • the illustrated embodiment is not intended to be limiting in any way.
  • the wire engaging surface 24 of the first forming member 20 and the wire engaging surface 34 of the second forming member 22 have substantially the same shape. In an embodiment, the shapes of the wire engaging surface 24 of the first forming member 20 and the wire engaging surface 34 of the second forming member 22 are different.
  • the second forming member 22 may be moved in the third direction 3D, as well as the second direction 2D and first direction 1D, by a second actuator 36 that is configured to move in the first direction 1D along a suitable structure, such as a rail 38 .
  • Actuation of the second actuator 36 may be controlled by the controller 30 , which also determines the X-Y position of the second forming member 22 relative to the wire 12 at any given time.
  • the controller 30 may be configured to signal the second actuator 36 to move the second forming member 22 to the desired coordinates within the wire forming area 16 .
  • the first actuator 26 may move the first forming member 20 in the third direction 3D away from the wire 12 .
  • the first actuator 26 may then move along the rail 28 to move the first forming member 20 in the first direction 1D, as illustrated in FIG. 5 , to a position that is downstream of the second forming member 22 relative to the direction of travel of the wire 12 along the axis, so that the first forming member 20 is on an opposite side of the second forming member 22 as compared to its previous position (shown in FIG. 3 ).
  • the first actuator 26 moves the first forming member 20 in the second direction 2D so that the wire engaging surface 24 of the first forming member 20 engages the wire 12 and deforms the wire 12 to the desired amount of deformation, as shown in FIG. 6 .
  • the first forming member 20 (and the clamp 18 ) may then be used to hold the wire 12 in position as the second actuator 36 moves the second forming member 22 away from the wire 12 in the second direction, as illustrated by FIG. 7 .
  • the second actuator 36 may move along the rail 38 so that the second forming member 22 moves in the first direction 1D to a position that is downstream of the first forming member 20 relative to the direction of travel of the wire 12 along the axis, as shown in FIG. 8 .
  • the second forming member 22 may then be moved by the second actuator 36 in the third direction 3D so that the wire engaging surface 34 of the second forming member 22 engages the wire 12 and deforms the wire 12 to the desired amount of deformation, as illustrated by FIG. 9 . This process may be repeated until the wire 12 within the wire forming area 16 has been deformed to its desired wave form 40 .
  • the first forming member 20 may be moved in the third direction 3D by the first actuator 26 and the second forming member 22 may be moved in the second direction 2D by the second actuator 36 to positions that are clear of the wire 12 .
  • the clamp 18 may be actuated to release the wire 12 .
  • the wire 12 may then be advanced in the first direction 1D so that the wave form 40 that was created in the wave forming area 16 may be moved out of the wave forming area 16 and a straight length of wire 12 may enter the wire forming area 16 via the inlet 15 , as shown in FIG. 11 .
  • the clamp 18 may be configured to grasp the wire form 40 in a manner that will not deform, i.e., straighten or otherwise alter, the wire form 40 .
  • FIG. 12 illustrates the beginning of a second cycle of the apparatus 10 to create a wire form for the next segment of the wire 12 .
  • the first forming member 20 is moved by the first actuator 26 in the second direction 2D to engage and deform the wire 12 in the same manner as discussed above with reference to FIG. 2 .
  • the sequence of movement of the first forming member 20 and the second forming member 22 may be the same as the sequence illustrated by FIGS. 3-11 , and may be further repeated until the desired length of wire 12 has been imparted with the desired wave form 40 .
  • FIGS. 13 and 14 illustrate embodiments of wave forms 42 , 44 , respectively, that may be produced on the apparatus 10 .
  • the wave forms 42 , 44 have generally sinusoidal shapes, each of which having curves that have substantially the same amplitude and frequency.
  • the amplitude of the curves may be varied by deforming the wire 12 in the apparatus 10 to a greater or lesser extent with the first and second forming members 20 , 22 .
  • the first and second forming member 20 , 22 may be moved greater distances after their respective wire engaging surfaces 24 , 34 have engaged the wire 12 , as compared to the distances travelled by the first and second forming members 20 , 22 after the wire engaging surfaces 24 , 34 have engaged the wire 12 to form the wire form 42 illustrated by FIG. 13 .
  • many other shapes may be formed and the embodiments illustrated in FIGS. 13 and 14 are not intended to be limiting in any way.
  • each wave that is formed may be different, i.e., may have a different amplitude, wavelength, shape, etc., as compared to adjacent waves.
  • each wave of the wave form may have a unique amplitude and wavelength.
  • FIG. 15 illustrates a portion of an apparatus 100 for forming a wave form for a stent from the wire 112 .
  • the wire 112 is provided to the apparatus 100 by a supply 114 , which may include a spool upon which the wire 112 is wound.
  • the wire 112 may be fed in the first direction 1D into an inlet 115 of a wire forming area 116 of the apparatus 100 .
  • the wire 112 extends through the wire forming area 116 substantially along an axis, and exits the wire forming area 116 via an outlet 117 .
  • a suitable clamp 118 may be located just outside the wire forming area 116 , as illustrated, or may be located within the wire forming area 116 .
  • the illustrated embodiment is not intended to be limiting in any way.
  • the clamp 118 is configured to clamp the wire 112 so that tension may be applied to the wire 112 as the wire 112 is formed into a predetermined shape, as discussed in further detail below.
  • the apparatus 100 also includes a plurality of first forming members 120 and a plurality of second forming members 122 , each of which being located within the wire forming area 116 . As illustrated, the first forming members 120 are located on one side of the wire 112 and the second forming members 122 are located on an opposite side of the wire 112 as compared to the first forming members 120 .
  • the first forming members 120 and the second forming members 122 have substantially elongated shapes, similar to the first and second forming members 20 , 22 described above.
  • Each of the first forming members 120 includes a wire engaging surface 124 that is configured to engage and the wire 112 when the first forming members 120 are moved in a second direction 2D′ that is substantially orthogonal to the first direction 1D. After the wire engaging surfaces 124 have engaged the wire 112 , the first forming members 20 continue to move in the second direction 2D′ to deform the wire 112 , as shown in FIG. 16 .
  • Each of the first forming members 120 may be moved in the second direction 2D′ by a respective first actuator 126 , all of which may be configured to move in the first direction 1D along a suitable structure, such as a rail 128 in a similar manner as described above with respect to the first actuator 26 and rail 28 .
  • Each of the first actuators 126 may be in communication with a controller 130 (as shown in FIG. 20 ) that is programmed to determine the X-Y position of each of the first forming members 120 relative to the wire 112 at any given time.
  • the controller 130 is configured to signal the first actuators 126 to move the first forming members 120 to the desired coordinates within the wire forming area 116 .
  • each of the second forming members 122 includes a wire engaging surface 134 that is configured to engage the wire 112 when the second forming members 122 are moved in a third direction 3D′.
  • the second forming members 122 continue to move in the third direction 3D′ to deform the wire 112 , as shown in FIG. 16 .
  • movement of the second forming members 122 in the third direction 3D′ is stopped and the wire 112 is momentarily held in place by the first forming members 120 and the second forming members 122 .
  • all of the wire engaging surfaces 124 of the first forming members 120 have substantially the same shape, and the wire engaging surfaces 134 of the second forming members 122 have substantially the same shape, and also have substantially the same shape as the wire engaging surfaces 124 of the first forming members 120 .
  • the shapes of the wire engaging surfaces 124 of the first forming members 20 and the wire engaging surfaces 134 of the second forming members 122 are different.
  • each of the wire engaging surfaces 124 , 134 are different. The illustrated embodiment is not intended to be limiting in any way.
  • the first actuators 126 move the first forming members 120 in the first direction 1D as well as the second direction 2D′.
  • the second actuators 136 move the second forming members 122 in the first direction 1D as well as the third direction 3D′ so that the wire 112 is engaged by the wire engaging surfaces 124 , 134 at about the same time.
  • the wire engaging surfaces 124 of the first forming members 120 engage the wire 112 before the wire engaging surfaces 134 of the second forming members 122 engage the wire 112 .
  • the wire engaging surfaces 134 of the second forming members 122 engaging the wire 112 before the wire engaging surfaces 124 of the first forming members 120 .
  • each of the first forming members 120 and the second forming members 122 may be actuated at different times so that the respective wire engaging surfaces 124 , 134 engage the wire 112 at different times.
  • the controller 130 may be programmed so that the desired sequence of actuations may occur to create the desired wave form in the wire 112 .
  • the first forming member 120 that is closest to the clamp 118 may be actuated first, and the second forming member 122 that is closest to the clamp 118 may be actuated second.
  • the remaining first and second forming members may be actuated in an alternating sequence until the first forming member that is closest to the inlet 115 of the wire forming area 116 is actuated.
  • All of the forming members 120 , 122 may be retracted from the wire 112 at the same time, and the wire may be advanced so that the portion of the wave form that was formed by the first forming member that is closest to the inlet 115 is aligned with the first forming member that is closest to the clamp 118 .
  • the sequence may repeat itself, starting with the first forming member engaging the already formed portion of the wire form.
  • the supply 114 may be configured to automatically advance the wire 112 as the wire 112 is deformed into the wave form, as long as a slight tension is maintained on the wire 112 so that the wire 112 remains straight within the wire forming area 116 until it is deformed.
  • the first forming members 120 may be moved in the third direction 3D′ to disengage from the wire 112
  • the second forming members 122 may be moved in the second direction 2D′ to disengage from the wire 112
  • the controller 130 may then signal the clamp 118 to open and may signal the supply 114 to advance the wire 112 a predetermined amount so that a new section of wire 112 may be advanced into the wire forming area 116 , as shown in FIG. 18 .
  • the first and second forming members 120 , 122 may be moved along their respective rails 128 , 138 in the fourth direction 4D so that another cycle may begin. Once the clamp 118 is closed, the process may be repeated until the desired amount of wire 112 has been formed into the desired wave form.
  • each wave that is formed may be different, i.e., may have a different amplitude, wavelength, shape, etc., as compared to adjacent waves.
  • each wave of the wave form may have a unique amplitude and wavelength.
  • FIG. 19 schematically illustrates communication between the controller 30 and other parts of the apparatus 10 that are illustrated in FIGS. 1-12 .
  • the controller 30 is configured to communicate with the supply 14 , the clamp 18 , the first actuator 26 , and the second actuator 36 .
  • the first actuator 26 is configured to move the first forming member 20 in both X and Y directions (using the coordinates depicted in FIG. 1 ).
  • the second actuator 36 is configured to move the second forming member 22 in both X and Y directions.
  • the controller 30 may signal the supply 14 , the clamp 18 , the first actuator 26 , and the second actuator 36 so that the apparatus 10 forms the desired wave form.
  • the controller 30 may signal the supply 14 , the clamp 18 , the first actuator 26 , and the second actuator 36 so that the apparatus 10 forms the desired wave form.
  • FIG. 20 schematically illustrates communication between the controller 130 and other parts of the apparatus 100 that are illustrated in FIGS. 15-18 .
  • the controller 130 is configured to communicate with the supply 114 , the clamp 118 , the first actuators 126 , and the second actuators 136 .
  • the first actuators 126 are each configured to move a corresponding first forming member 120 in both X and Y directions (using the coordinates depicted in FIG. 15 ).
  • the second actuators 136 are each configured to move a corresponding second forming member 122 in both X and Y directions.
  • the controller 130 may signal the supply 114 , the clamp 118 , the first actuators 126 , and the second actuators 136 so that the apparatus 100 forms the desired wave form.

Abstract

An apparatus for forming a wave form for a stent from a wire includes a first forming member configured to move substantially parallel to a first axis and to move substantially parallel to a second axis that is orthogonal to the first axis, and a second forming member configured to move substantially parallel to the first axis and to move substantially parallel to the second axis. The second forming member is positioned opposite from the first forming member relative to the second axis along which the wire is configured to travel. The apparatus includes a controller configured to control movement of the first forming member relative to the wire and to control movement of the second forming member relative to the wire so that the first forming member and the second forming member deform the wire in opposite directions to form a portion of the wave form.

Description

    BACKGROUND OF THE INVENTION
  • 1. Field of the Invention
  • The present invention is generally related to an apparatus and method for forming a wave form for a stent. More particularly, the present invention is related to an apparatus and method for forming the wave form from a wire.
  • 2. Background of the Invention
  • A stent is typically a hollow, generally cylindrical device that is deployed in a body lumen from a radially contracted configuration into a radially expanded configuration, which allows it to contact and support a vessel wall. A plastically deformable stent can be implanted during an angioplasty procedure by using a balloon catheter bearing a compressed or “crimped” stent, which has been loaded onto the balloon. The stent radially expands as the balloon is inflated, forcing the stent into contact with the body lumen, thereby forming a support for the vessel wall. Deployment is effected after the stent has been introduced percutaneously, transported transluminally, and positioned at a desired location by means of the balloon catheter.
  • Stents may be formed from wire(s), may be cut from a tube, or may be cut from a sheet of material and then rolled into a tube-like structure. While some stents may include a plurality of connected rings that are substantially parallel to each other and are oriented substantially perpendicular to a longitudinal axis of the stent, others may include a helical coil that is wrapped around the longitudinal axis at a non-perpendicular angle.
  • A stent that includes a helical coil may be formed from a single wire that includes a wave form that is configured to allow the stent to radially expand. In view of the small size of the stents, it may be difficult to form a stent from a single wire while controlling the wave form so that the end result is a stent that expands uniformly along its length.
  • SUMMARY OF THE INVENTION
  • Embodiments of the present invention describe an apparatus and method for forming a wave form for a stent from a single wire.
  • According to an aspect of the present invention, there is provided an apparatus for forming a wave form for a stent from a wire. The apparatus includes a first forming member configured to move substantially parallel to a first axis and to move substantially parallel to a second axis that is orthogonal to the first axis, and a second forming member configured to move substantially parallel to the first axis and to move substantially parallel to the second axis. The second forming member is positioned opposite from the first forming member relative to the second axis along which the wire is configured to travel. The apparatus includes a controller configured to control movement of the first forming member relative to the wire and to control movement of the second forming member relative to the wire so that the first forming member and the second forming member deform the wire in opposite directions to form a portion of the wave form.
  • According to an aspect of the present invention, there is provided a method for forming a wave form for a stent from a wire. The method includes deforming the wire by moving a first forming member in a first direction substantially perpendicular to a wire axis defined by the wire prior to being deformed, and deforming the wire by moving a second forming member located on a first side of the first forming member in a second direction that is substantially opposite to the first direction. The method includes moving the first forming member away from the wire, moving the first forming member in a third direction substantially parallel to the wire axis to a position on an opposite side of the second forming member, and deforming the wire by moving the first forming member in the first direction.
  • According to an aspect of the present invention, there is provided an apparatus for forming a wave form for a stent from a wire. The apparatus includes a plurality of first forming members spaced apart from one another along a wire axis. Each first forming member is configured to move substantially parallel to the wire axis and to move substantially parallel to a second axis that is orthogonal to the wire axis. The apparatus also includes a plurality of second forming members spaced apart from one another along the wire axis so that at least one of the second forming members is in between two of the first forming members along the wire axis. Each second forming member is configured to move substantially parallel to the wire axis and to move substantially parallel to the second axis. The apparatus includes a controller configured to control movement of the first forming members and movement of the second forming members so that the first forming members and the second forming members deform the wire in opposite directions to form a portion of the wave form.
  • According to an aspect of the present invention, there is provided a method for forming a stent from a wire. The method includes deforming the wire with a plurality of first forming members by moving the first forming members in a first direction, deforming the wire with a plurality of second forming members by moving the second forming members in a second direction that is substantially opposite the first direction, and moving the first forming members and the second forming members in a third direction that is substantially orthogonal to the first and second directions. The method includes moving the first forming members away from the wire in the second direction, moving the second forming members away from the wire in the first direction, and advancing the wire in the third direction.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • Embodiments of the invention will now be described, by way of example only, with reference to the accompanying schematic drawings in which corresponding reference symbols indicate corresponding parts, and in which:
  • FIG. 1 is a schematic view of an apparatus for forming a wave form for a stent from a wire when the wire is first fed into the apparatus, and a first forming member and a second forming member are in home positions;
  • FIG. 2 is a schematic view of the apparatus of FIG. 1 when the first forming member engages and deforms the wire;
  • FIG. 3 is a schematic view of the apparatus of FIG. 2 when the second forming member engages and deforms the wire;
  • FIG. 4 is a schematic view of the apparatus of FIG. 3 when the second forming member moves away from the wire;
  • FIG. 5 is a schematic view of the apparatus of FIG. 4 when the second forming member moves in a direction substantially parallel to the wire;
  • FIG. 6 is a schematic view of the apparatus of FIG. 5 when the second forming member engages and deforms the wire;
  • FIG. 7 is a schematic view of the apparatus of FIG. 6 when the first forming member disengages the wire;
  • FIG. 8 is a schematic view of the apparatus of FIG. 7 when the first forming member moves in the direction substantially parallel to the wire;
  • FIG. 9 is a schematic view of the apparatus of FIG. 8 when the first forming member engages and deforms the wire;
  • FIG. 10 is a schematic view of the apparatus of FIG. 9 when the first forming member and the second forming member disengage the wire;
  • FIG. 11 is a schematic view of the apparatus of FIG. 10 when the wire is moved relative to the apparatus and the first forming member and the second forming member return to their respective home positions;
  • FIG. 12 is a schematic view of the apparatus of FIG. 11 when the first forming member engages and deforms the wire;
  • FIG. 13 is a schematic view of a first waveform produced with the apparatus of FIGS. 1-12;
  • FIG. 14 is a schematic view of a second waveform produced with the apparatus of FIGS. 1-12;
  • FIG. 15 is a schematic view of another embodiment of an apparatus for forming a wave form for a stent from a wire when the wire is first fed into the apparatus, and a plurality of first forming members and a plurality of second forming members are in their respective home positions;
  • FIG. 16 is a schematic view of the apparatus of FIG. 15 when the first forming members and the second forming members engage and deform the wire to form the wave form;
  • FIG. 17 is a schematic view of the apparatus of FIG. 15 when the first forming members and the second forming members disengage and move away from the wire;
  • FIG. 18 is a schematic view of the apparatus of FIG. 15 when the wire is moves relative to the apparatus, and the first forming members and the second forming members return to their respective home positions;
  • FIG. 19 is a schematic block diagram that illustrates communication between a controller and other parts of the apparatus of FIGS. 1-12; and
  • FIG. 20 is a schematic block diagram that illustrates communication between a controller and other parts of the apparatus of FIGS. 15-18.
  • DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
  • The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and use of the invention. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.
  • FIG. 1 schematically illustrates a portion of an apparatus 10 for forming a wave form for a stent from a wire 12. A supply 14 of the wire 12 is provided to the apparatus 10. In an embodiment, the supply 14 may include a spool upon which the wire 12 is wound. The wire 12 may have any suitable diameter for the intended stent application. In an embodiment, the wire 12 may have a diameter between about 0.0025″ and about 0.0050″.
  • The supply 14 may be mounted outside of the apparatus 10 or within the apparatus 10 so that the wire 12 may be fed in a first direction 1D into a wire forming area 16 of the apparatus 10 via an inlet 15. As illustrated, the wire 12 extends through the wire forming area 16 substantially along an axis, and exits the wire forming area 16 via an outlet 17. A suitable clamp 18 may be located just outside the wire forming area 16, as illustrated, or may be located within the wire forming area 16. The illustrated embodiment is not intended to be limiting in any way. The clamp 18 is configured to clamp the wire 12 so that tension may be applied to the wire 12 as the wire 12 is formed into a predetermined shape, as discussed in further detail below.
  • The apparatus 10 also includes a first forming member 20 and a second forming member 22, each of which being located within the wire forming area 16. As illustrated, the first forming member 20 is located on one side of the wire 12 and the second forming member 22 is located on an opposite side of the wire 12 as compared to the first forming member 20. The first forming member 20 and the second forming member 22 each have a substantially elongated shape, similar to a finger, that is oriented substantially perpendicular to a (longitudinal) wire axis that is defined by the wire 12, as illustrated.
  • The first forming member 20 includes a wire engaging surface 24 that is configured to engage the wire 12 when the first forming member 20 is moved in a second direction 2D that is substantially orthogonal to the first direction 1D. After the wire engaging surface 24 has engaged the wire 12, the first forming member 20 continues to move in the second direction 2D to deform the wire 12, as shown in FIG. 2. When the desired deformation is obtained, movement of the first forming member 20 in the second direction 2D is stopped and the wire 12 is held in place by the first forming member 20, as well as the clamp 18. Although the wire engaging surface 24 of the first forming member 20 is illustrated as having a triangular configuration, such a configuration is shown for schematic purposes. For example, the wire engaging surface 24 may be more rounded and may have a tip that has a radius that is substantially the same as the inner radius of the desired shape of the deformed wire. The illustrated embodiment is not intended to be limiting in any way.
  • The first forming member 20 may be moved in the second direction 2D by a first actuator 26, which may be configured to move in the first direction 1D along a suitable structure, such as a rail 28. Such X-Y actuators are known in the actuator art and therefore will not be discussed in further detail herein. The first actuator 26 may be in communication with a controller 30 (as shown in FIG. 19) that is programmed to determine the X-Y position of the first forming member 20 relative to the wire 12 at any given time. The controller 30 is configured to signal the first actuator 26 to move the first forming member 20 to the desired coordinates within the wire forming area 16, as discussed in further detail below.
  • Similarly, the second forming member 22 includes a wire engaging surface 34 that is configured to engage the wire 12 when the second forming member 22 is moved in a third direction 3D that is substantially opposite to the second direction 2D and orthogonal to the first direction 1D. After the wire engaging surface 34 has engaged the wire 12, the second forming member 22 continues to move in the third direction 3D to deform the wire 12, as shown in FIG. 3. When the desired deformation is obtained, movement of the second forming member 22 in the third direction 3D is stopped and the wire 12 is momentarily held in place by both the first forming member 20 and the second forming member 22. Although the wire engaging surface 34 of the second forming member 22 is illustrated as having a triangular configuration, such a configuration is shown for schematic purposes. For example, like the wire engaging surface 24 of the first forming member 20, the wire engaging surface 34 may be more rounded and may have a tip that has a radius that is substantially the same as the inner radius of the desired shape of the deformed wire. The illustrated embodiment is not intended to be limiting in any way.
  • In an embodiment, the wire engaging surface 24 of the first forming member 20 and the wire engaging surface 34 of the second forming member 22 have substantially the same shape. In an embodiment, the shapes of the wire engaging surface 24 of the first forming member 20 and the wire engaging surface 34 of the second forming member 22 are different.
  • The second forming member 22 may be moved in the third direction 3D, as well as the second direction 2D and first direction 1D, by a second actuator 36 that is configured to move in the first direction 1D along a suitable structure, such as a rail 38. Actuation of the second actuator 36 may be controlled by the controller 30, which also determines the X-Y position of the second forming member 22 relative to the wire 12 at any given time. The controller 30 may be configured to signal the second actuator 36 to move the second forming member 22 to the desired coordinates within the wire forming area 16.
  • As illustrated in FIG. 4, after the second forming member 22 has deformed the wire 12, the first actuator 26 may move the first forming member 20 in the third direction 3D away from the wire 12. The first actuator 26 may then move along the rail 28 to move the first forming member 20 in the first direction 1D, as illustrated in FIG. 5, to a position that is downstream of the second forming member 22 relative to the direction of travel of the wire 12 along the axis, so that the first forming member 20 is on an opposite side of the second forming member 22 as compared to its previous position (shown in FIG. 3). Once the first forming member 20 is positioned at the desired location relative to the second forming member 22, the first actuator 26 moves the first forming member 20 in the second direction 2D so that the wire engaging surface 24 of the first forming member 20 engages the wire 12 and deforms the wire 12 to the desired amount of deformation, as shown in FIG. 6.
  • The first forming member 20 (and the clamp 18) may then be used to hold the wire 12 in position as the second actuator 36 moves the second forming member 22 away from the wire 12 in the second direction, as illustrated by FIG. 7. After the second forming member 22 has cleared the wire 12, the second actuator 36 may move along the rail 38 so that the second forming member 22 moves in the first direction 1D to a position that is downstream of the first forming member 20 relative to the direction of travel of the wire 12 along the axis, as shown in FIG. 8. The second forming member 22 may then be moved by the second actuator 36 in the third direction 3D so that the wire engaging surface 34 of the second forming member 22 engages the wire 12 and deforms the wire 12 to the desired amount of deformation, as illustrated by FIG. 9. This process may be repeated until the wire 12 within the wire forming area 16 has been deformed to its desired wave form 40.
  • As illustrated by FIG. 10, after the wire 12 has been deformed to its desired wave form 40 in the wire forming area 16, the first forming member 20 may be moved in the third direction 3D by the first actuator 26 and the second forming member 22 may be moved in the second direction 2D by the second actuator 36 to positions that are clear of the wire 12. At substantially the same time, the clamp 18 may be actuated to release the wire 12. The wire 12 may then be advanced in the first direction 1D so that the wave form 40 that was created in the wave forming area 16 may be moved out of the wave forming area 16 and a straight length of wire 12 may enter the wire forming area 16 via the inlet 15, as shown in FIG. 11. The clamp 18 may be configured to grasp the wire form 40 in a manner that will not deform, i.e., straighten or otherwise alter, the wire form 40.
  • FIG. 12 illustrates the beginning of a second cycle of the apparatus 10 to create a wire form for the next segment of the wire 12. As illustrated, the first forming member 20 is moved by the first actuator 26 in the second direction 2D to engage and deform the wire 12 in the same manner as discussed above with reference to FIG. 2. The sequence of movement of the first forming member 20 and the second forming member 22 may be the same as the sequence illustrated by FIGS. 3-11, and may be further repeated until the desired length of wire 12 has been imparted with the desired wave form 40. For example, FIGS. 13 and 14 illustrate embodiments of wave forms 42, 44, respectively, that may be produced on the apparatus 10. As illustrated, the wave forms 42, 44 have generally sinusoidal shapes, each of which having curves that have substantially the same amplitude and frequency. The amplitude of the curves may be varied by deforming the wire 12 in the apparatus 10 to a greater or lesser extent with the first and second forming members 20, 22. For example, to create the wire form 44 shown in FIG. 14, the first and second forming member 20, 22 may be moved greater distances after their respective wire engaging surfaces 24, 34 have engaged the wire 12, as compared to the distances travelled by the first and second forming members 20, 22 after the wire engaging surfaces 24, 34 have engaged the wire 12 to form the wire form 42 illustrated by FIG. 13. Of course, many other shapes may be formed and the embodiments illustrated in FIGS. 13 and 14 are not intended to be limiting in any way.
  • For example, because the movement of the wire 12, the first forming member 20, and the second forming member 22 are controlled by the controller 30, each wave that is formed may be different, i.e., may have a different amplitude, wavelength, shape, etc., as compared to adjacent waves. In an embodiment, each wave of the wave form may have a unique amplitude and wavelength.
  • FIG. 15 illustrates a portion of an apparatus 100 for forming a wave form for a stent from the wire 112. Like the embodiment illustrated in FIGS. 1-12, the wire 112 is provided to the apparatus 100 by a supply 114, which may include a spool upon which the wire 112 is wound. The wire 112 may be fed in the first direction 1D into an inlet 115 of a wire forming area 116 of the apparatus 100. As illustrated, the wire 112 extends through the wire forming area 116 substantially along an axis, and exits the wire forming area 116 via an outlet 117. A suitable clamp 118 may be located just outside the wire forming area 116, as illustrated, or may be located within the wire forming area 116. The illustrated embodiment is not intended to be limiting in any way. The clamp 118 is configured to clamp the wire 112 so that tension may be applied to the wire 112 as the wire 112 is formed into a predetermined shape, as discussed in further detail below.
  • The apparatus 100 also includes a plurality of first forming members 120 and a plurality of second forming members 122, each of which being located within the wire forming area 116. As illustrated, the first forming members 120 are located on one side of the wire 112 and the second forming members 122 are located on an opposite side of the wire 112 as compared to the first forming members 120. The first forming members 120 and the second forming members 122 have substantially elongated shapes, similar to the first and second forming members 20, 22 described above.
  • Each of the first forming members 120 includes a wire engaging surface 124 that is configured to engage and the wire 112 when the first forming members 120 are moved in a second direction 2D′ that is substantially orthogonal to the first direction 1D. After the wire engaging surfaces 124 have engaged the wire 112, the first forming members 20 continue to move in the second direction 2D′ to deform the wire 112, as shown in FIG. 16.
  • Each of the first forming members 120 may be moved in the second direction 2D′ by a respective first actuator 126, all of which may be configured to move in the first direction 1D along a suitable structure, such as a rail 128 in a similar manner as described above with respect to the first actuator 26 and rail 28. Each of the first actuators 126 may be in communication with a controller 130 (as shown in FIG. 20) that is programmed to determine the X-Y position of each of the first forming members 120 relative to the wire 112 at any given time. The controller 130 is configured to signal the first actuators 126 to move the first forming members 120 to the desired coordinates within the wire forming area 116.
  • Similarly, each of the second forming members 122 includes a wire engaging surface 134 that is configured to engage the wire 112 when the second forming members 122 are moved in a third direction 3D′. After the wire engaging surfaces 134 have engaged the wire 112, the second forming members 122 continue to move in the third direction 3D′ to deform the wire 112, as shown in FIG. 16. When the desired deformation is obtained, movement of the second forming members 122 in the third direction 3D′ is stopped and the wire 112 is momentarily held in place by the first forming members 120 and the second forming members 122.
  • In an embodiment, all of the wire engaging surfaces 124 of the first forming members 120 have substantially the same shape, and the wire engaging surfaces 134 of the second forming members 122 have substantially the same shape, and also have substantially the same shape as the wire engaging surfaces 124 of the first forming members 120. In an embodiment, the shapes of the wire engaging surfaces 124 of the first forming members 20 and the wire engaging surfaces 134 of the second forming members 122 are different. In an embodiment, each of the wire engaging surfaces 124, 134 are different. The illustrated embodiment is not intended to be limiting in any way.
  • As illustrated in FIG. 16, the first actuators 126 move the first forming members 120 in the first direction 1D as well as the second direction 2D′. At substantially the same time, the second actuators 136 move the second forming members 122 in the first direction 1D as well as the third direction 3D′ so that the wire 112 is engaged by the wire engaging surfaces 124, 134 at about the same time. In an embodiment, the wire engaging surfaces 124 of the first forming members 120 engage the wire 112 before the wire engaging surfaces 134 of the second forming members 122 engage the wire 112. In an embodiment, the wire engaging surfaces 134 of the second forming members 122 engaging the wire 112 before the wire engaging surfaces 124 of the first forming members 120. In an embodiment, each of the first forming members 120 and the second forming members 122 may be actuated at different times so that the respective wire engaging surfaces 124, 134 engage the wire 112 at different times. The controller 130 may be programmed so that the desired sequence of actuations may occur to create the desired wave form in the wire 112.
  • For example, in an embodiment, the first forming member 120 that is closest to the clamp 118 may be actuated first, and the second forming member 122 that is closest to the clamp 118 may be actuated second. The remaining first and second forming members may be actuated in an alternating sequence until the first forming member that is closest to the inlet 115 of the wire forming area 116 is actuated. All of the forming members 120, 122 may be retracted from the wire 112 at the same time, and the wire may be advanced so that the portion of the wave form that was formed by the first forming member that is closest to the inlet 115 is aligned with the first forming member that is closest to the clamp 118. The sequence may repeat itself, starting with the first forming member engaging the already formed portion of the wire form. The supply 114 may be configured to automatically advance the wire 112 as the wire 112 is deformed into the wave form, as long as a slight tension is maintained on the wire 112 so that the wire 112 remains straight within the wire forming area 116 until it is deformed.
  • As illustrated in FIG. 17, after a wave form 140 has been formed, the first forming members 120 may be moved in the third direction 3D′ to disengage from the wire 112, and the second forming members 122 may be moved in the second direction 2D′ to disengage from the wire 112. The controller 130 may then signal the clamp 118 to open and may signal the supply 114 to advance the wire 112 a predetermined amount so that a new section of wire 112 may be advanced into the wire forming area 116, as shown in FIG. 18. At about the same time, the first and second forming members 120, 122 may be moved along their respective rails 128, 138 in the fourth direction 4D so that another cycle may begin. Once the clamp 118 is closed, the process may be repeated until the desired amount of wire 112 has been formed into the desired wave form.
  • For example, because the movement of the wire 112, the first forming members 120, and the second forming members 122 are controlled by the controller 130, each wave that is formed may be different, i.e., may have a different amplitude, wavelength, shape, etc., as compared to adjacent waves. In an embodiment, each wave of the wave form may have a unique amplitude and wavelength.
  • FIG. 19 schematically illustrates communication between the controller 30 and other parts of the apparatus 10 that are illustrated in FIGS. 1-12. As illustrated, the controller 30 is configured to communicate with the supply 14, the clamp 18, the first actuator 26, and the second actuator 36. As discussed above, the first actuator 26 is configured to move the first forming member 20 in both X and Y directions (using the coordinates depicted in FIG. 1). Similarly, the second actuator 36 is configured to move the second forming member 22 in both X and Y directions. Once the desired wave form has been communicated to the controller 30, and the controller 30 is able to access a computer readable medium that contains a method for forming the desired wave form, as described herein, the controller 30 may signal the supply 14, the clamp 18, the first actuator 26, and the second actuator 36 so that the apparatus 10 forms the desired wave form. Although a particular sequence of movement of the forming members 20, 22 is described above, other sequences may be programmed for execution by the controller. For example, in an embodiment, the second forming member 22 may be moved prior to the first forming member 20.
  • FIG. 20 schematically illustrates communication between the controller 130 and other parts of the apparatus 100 that are illustrated in FIGS. 15-18. As illustrated, the controller 130 is configured to communicate with the supply 114, the clamp 118, the first actuators 126, and the second actuators 136. As discussed above, the first actuators 126 are each configured to move a corresponding first forming member 120 in both X and Y directions (using the coordinates depicted in FIG. 15). Similarly, the second actuators 136 are each configured to move a corresponding second forming member 122 in both X and Y directions. Once the desired wave form has been communicated to the controller 130, and the controller 130 is able to access a computer readable medium that contains a method for forming the desired wave form, as described herein, the controller 130 may signal the supply 114, the clamp 118, the first actuators 126, and the second actuators 136 so that the apparatus 100 forms the desired wave form.
  • While at least one exemplary embodiment has been presented in the foregoing detailed description of the invention, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or exemplary embodiments are only examples, and are not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient roadmap for implementing an exemplary embodiment of the invention, it being understood that various changes may be made in the function and arrangement of members described in an exemplary embodiment without departing from the scope of the invention as set forth in the appended claims.

Claims (19)

1. An apparatus for forming a wave form for a stent from a wire, the apparatus comprising:
a first forming member configured to move substantially parallel to a first axis and to move substantially parallel to a second axis that is orthogonal to the first axis;
a second forming member configured to move substantially parallel to the first axis and to move substantially parallel to the second axis, the second forming member being positioned opposite from the first forming member relative to the second axis along which the wire is configured to travel; and
a controller configured to control movement of the first forming member relative to the wire and to control movement of the second forming member relative to the wire so that the first forming member and the second forming member deform the wire in opposite directions to form a portion of the wave form.
2. The apparatus according to claim 1, further comprising a first actuator configured to move the first forming member substantially parallel to the first axis and substantially parallel to the second axis, wherein the first actuator is configured to be controlled by the controller.
3. The apparatus according to claim 1, further comprising a second actuator configured to move the second forming member substantially parallel to the first axis and substantially parallel to the second axis, wherein the second actuator is configured to be controlled by the controller.
4. The apparatus according to claim 1, wherein the first forming member comprises a first engaging surface configured to engage the wire when the first forming member is moved in a first direction substantially parallel to the first axis, and wherein the second forming member comprises a second engaging surface configured to engage the wire when the second forming member is moved in a second direction that is substantially opposite to the first direction.
5. The apparatus according to claim 4, wherein the first engaging surface and the second engaging surface have substantially the same configuration.
6. A method for forming a wave form for a stent from a wire, the method comprising:
deforming the wire by moving a first forming member in a first direction substantially perpendicular to a wire axis defined by the wire prior to being deformed;
deforming the wire by moving a second forming member located on a first side of the first forming member in a second direction that is substantially opposite to the first direction;
moving the first forming member away from the wire;
moving the first forming member in a third direction substantially parallel to the wire axis to a position on an opposite side of the second forming member; and
deforming the wire by moving the first forming member in the first direction.
7. The method according to claim 6, further comprising:
moving the second forming member in the first direction away from the wire;
moving the second forming member in the third direction to a position on an opposite side of the first forming member so that the first side of the first forming member faces the second forming member; and
deforming the wire by moving the second forming member in the second direction.
8. The method according to claim 7, further comprising:
moving the first forming member and the second forming member away from the wire; and
advancing the wire in the third direction.
9. The method according to claim 6, wherein the first forming member and the second forming member deform the wire substantially the same amount.
10. The method according to claim 6, wherein the wire has a diameter in a range between about 0.0025″ and about 0.0050″.
11. An apparatus for forming a wave form for a stent from a wire, the apparatus comprising:
a plurality of first forming members spaced apart from one another along a wire axis, each first forming member being configured to move substantially parallel to the wire axis and to move substantially parallel to a second axis that is orthogonal to the wire axis;
a plurality of second forming members spaced apart from one another along the wire axis so that at least one of the second forming members is in between two of the first forming members along the wire axis, each second forming member being configured to move substantially parallel to the wire axis and to move substantially parallel to the second axis; and
a controller configured to control movement of the first forming members and movement of the second forming members so that the first forming members and the second forming members deform the wire in opposite directions to form a portion of the wave form.
12. The apparatus according to claim 11, further comprising a plurality of first actuators, each of which being configured to move a respective first forming member substantially parallel to the wire axis and substantially parallel to the second axis, wherein the first actuators are configured to be controlled by the controller.
13. The apparatus according to claim 11, further comprising a plurality of second actuators, each of which being configured to move a respective second forming member substantially parallel to the wire axis and substantially parallel to the second axis, wherein the second actuators are configured to be controlled by the controller.
14. The apparatus according to claim 1, wherein each of the first forming members comprises a first engaging surface configured to engage the wire when the first forming member is moved in a first direction substantially parallel to the second axis, and wherein each of the second forming members comprises a second engaging surface configured to engage the wire when the second forming member is moved in a second direction that is substantially opposite to the first direction.
15. The apparatus according to claim 14, wherein the first engaging surfaces and the second engaging surfaces have substantially the same configuration.
16. A method for forming a stent from a wire, the method comprising:
deforming the wire with a plurality of first forming members by moving the first forming members in a first direction;
deforming the wire with a plurality of second forming members by moving the second forming members in a second direction that is substantially opposite the first direction;
moving the first forming members and the second forming members in a third direction that is substantially orthogonal to the first and second directions;
moving the first forming members away from the wire in the second direction;
moving the second forming members away from the wire in the first direction; and
advancing the wire in the third direction.
17. The method according to claim 16, wherein said deforming the wire with the plurality of first forming members and said deforming the wire with the plurality of second forming members occurs at substantially the same time.
18. The method according to claim 16, wherein the first forming members and the second forming members deform the wire substantially the same amount.
19. The method according to claim 16, wherein the wire has a diameter in a range between about 0.0025″ and about 0.0050″.
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