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.
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.
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:
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.
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
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
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
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
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
As illustrated by
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.
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
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
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
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
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
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.
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.