BACKGROUND OF THE INVENTION1. 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 INVENTIONEmbodiments 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 DRAWINGSEmbodiments 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 ofFIG. 1 when the first forming member engages and deforms the wire;
FIG. 3 is a schematic view of the apparatus ofFIG. 2 when the second forming member engages and deforms the wire;
FIG. 4 is a schematic view of the apparatus ofFIG. 3 when the second forming member moves away from the wire;
FIG. 5 is a schematic view of the apparatus ofFIG. 4 when the second forming member moves in a direction substantially parallel to the wire;
FIG. 6 is a schematic view of the apparatus ofFIG. 5 when the second forming member engages and deforms the wire;
FIG. 7 is a schematic view of the apparatus ofFIG. 6 when the first forming member disengages the wire;
FIG. 8 is a schematic view of the apparatus ofFIG. 7 when the first forming member moves in the direction substantially parallel to the wire;
FIG. 9 is a schematic view of the apparatus ofFIG. 8 when the first forming member engages and deforms the wire;
FIG. 10 is a schematic view of the apparatus ofFIG. 9 when the first forming member and the second forming member disengage the wire;
FIG. 11 is a schematic view of the apparatus ofFIG. 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 ofFIG. 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 ofFIGS. 1-12;
FIG. 14 is a schematic view of a second waveform produced with the apparatus ofFIGS. 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 ofFIG. 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 ofFIG. 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 ofFIG. 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 ofFIGS. 1-12; and
FIG. 20 is a schematic block diagram that illustrates communication between a controller and other parts of the apparatus ofFIGS. 15-18.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTIONThe 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 anapparatus10 for forming a wave form for a stent from awire12. Asupply14 of thewire12 is provided to theapparatus10. In an embodiment, thesupply14 may include a spool upon which thewire12 is wound. Thewire12 may have any suitable diameter for the intended stent application. In an embodiment, thewire12 may have a diameter between about 0.0025″ and about 0.0050″.
Thesupply14 may be mounted outside of theapparatus10 or within theapparatus10 so that thewire12 may be fed in afirst direction 1D into awire forming area16 of theapparatus10 via aninlet15. As illustrated, thewire12 extends through thewire forming area16 substantially along an axis, and exits thewire forming area16 via anoutlet17. Asuitable clamp18 may be located just outside thewire forming area16, as illustrated, or may be located within thewire forming area16. The illustrated embodiment is not intended to be limiting in any way. Theclamp18 is configured to clamp thewire12 so that tension may be applied to thewire12 as thewire12 is formed into a predetermined shape, as discussed in further detail below.
Theapparatus10 also includes a first formingmember20 and a second formingmember22, each of which being located within thewire forming area16. As illustrated, the first formingmember20 is located on one side of thewire12 and the second formingmember22 is located on an opposite side of thewire12 as compared to the first formingmember20. The first formingmember20 and the second formingmember22 each have a substantially elongated shape, similar to a finger, that is oriented substantially perpendicular to a (longitudinal) wire axis that is defined by thewire12, as illustrated.
The first formingmember20 includes awire engaging surface24 that is configured to engage thewire12 when the first formingmember20 is moved in asecond direction 2D that is substantially orthogonal to thefirst direction 1D. After thewire engaging surface24 has engaged thewire12, the first formingmember20 continues to move in thesecond direction 2D to deform thewire12, as shown inFIG. 2. When the desired deformation is obtained, movement of the first formingmember20 in thesecond direction 2D is stopped and thewire12 is held in place by the first formingmember20, as well as theclamp18. Although thewire engaging surface24 of the first formingmember20 is illustrated as having a triangular configuration, such a configuration is shown for schematic purposes. For example, thewire engaging surface24 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 formingmember20 may be moved in thesecond direction 2D by afirst actuator26, which may be configured to move in thefirst direction 1D along a suitable structure, such as arail28. Such X-Y actuators are known in the actuator art and therefore will not be discussed in further detail herein. Thefirst actuator26 may be in communication with a controller30 (as shown inFIG. 19) that is programmed to determine the X-Y position of the first formingmember20 relative to thewire12 at any given time. Thecontroller30 is configured to signal thefirst actuator26 to move the first formingmember20 to the desired coordinates within thewire forming area16, as discussed in further detail below.
Similarly, the second formingmember22 includes awire engaging surface34 that is configured to engage thewire12 when the second formingmember22 is moved in athird direction 3D that is substantially opposite to thesecond direction 2D and orthogonal to thefirst direction 1D. After thewire engaging surface34 has engaged thewire12, the second formingmember22 continues to move in thethird direction 3D to deform thewire12, as shown inFIG. 3. When the desired deformation is obtained, movement of the second formingmember22 in thethird direction 3D is stopped and thewire12 is momentarily held in place by both the first formingmember20 and the second formingmember22. Although thewire engaging surface34 of the second formingmember22 is illustrated as having a triangular configuration, such a configuration is shown for schematic purposes. For example, like thewire engaging surface24 of the first formingmember20, thewire engaging surface34 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, thewire engaging surface24 of the first formingmember20 and thewire engaging surface34 of the second formingmember22 have substantially the same shape. In an embodiment, the shapes of thewire engaging surface24 of the first formingmember20 and thewire engaging surface34 of the second formingmember22 are different.
The second formingmember22 may be moved in thethird direction 3D, as well as thesecond direction 2D andfirst direction 1D, by asecond actuator36 that is configured to move in thefirst direction 1D along a suitable structure, such as arail38. Actuation of thesecond actuator36 may be controlled by thecontroller30, which also determines the X-Y position of the second formingmember22 relative to thewire12 at any given time. Thecontroller30 may be configured to signal thesecond actuator36 to move the second formingmember22 to the desired coordinates within thewire forming area16.
As illustrated inFIG. 4, after the second formingmember22 has deformed thewire12, thefirst actuator26 may move the first formingmember20 in thethird direction 3D away from thewire12. Thefirst actuator26 may then move along therail28 to move the first formingmember20 in thefirst direction 1D, as illustrated inFIG. 5, to a position that is downstream of the second formingmember22 relative to the direction of travel of thewire12 along the axis, so that the first formingmember20 is on an opposite side of the second formingmember22 as compared to its previous position (shown inFIG. 3). Once the first formingmember20 is positioned at the desired location relative to the second formingmember22, thefirst actuator26 moves the first formingmember20 in thesecond direction 2D so that thewire engaging surface24 of the first formingmember20 engages thewire12 and deforms thewire12 to the desired amount of deformation, as shown inFIG. 6.
The first forming member20 (and the clamp18) may then be used to hold thewire12 in position as thesecond actuator36 moves the second formingmember22 away from thewire12 in the second direction, as illustrated byFIG. 7. After the second formingmember22 has cleared thewire12, thesecond actuator36 may move along therail38 so that the second formingmember22 moves in thefirst direction 1D to a position that is downstream of the first formingmember20 relative to the direction of travel of thewire12 along the axis, as shown inFIG. 8. The second formingmember22 may then be moved by thesecond actuator36 in thethird direction 3D so that thewire engaging surface34 of the second formingmember22 engages thewire12 and deforms thewire12 to the desired amount of deformation, as illustrated byFIG. 9. This process may be repeated until thewire12 within thewire forming area16 has been deformed to its desiredwave form40.
As illustrated byFIG. 10, after thewire12 has been deformed to its desiredwave form40 in thewire forming area16, the first formingmember20 may be moved in thethird direction 3D by thefirst actuator26 and the second formingmember22 may be moved in thesecond direction 2D by thesecond actuator36 to positions that are clear of thewire12. At substantially the same time, theclamp18 may be actuated to release thewire12. Thewire12 may then be advanced in thefirst direction 1D so that thewave form40 that was created in thewave forming area16 may be moved out of thewave forming area16 and a straight length ofwire12 may enter thewire forming area16 via theinlet15, as shown inFIG. 11. Theclamp18 may be configured to grasp thewire form40 in a manner that will not deform, i.e., straighten or otherwise alter, thewire form40.
FIG. 12 illustrates the beginning of a second cycle of theapparatus10 to create a wire form for the next segment of thewire12. As illustrated, the first formingmember20 is moved by thefirst actuator26 in thesecond direction 2D to engage and deform thewire12 in the same manner as discussed above with reference toFIG. 2. The sequence of movement of the first formingmember20 and the second formingmember22 may be the same as the sequence illustrated byFIGS. 3-11, and may be further repeated until the desired length ofwire12 has been imparted with the desiredwave form40. For example,FIGS. 13 and 14 illustrate embodiments of wave forms42,44, respectively, that may be produced on theapparatus10. As illustrated, the wave forms42,44 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 thewire12 in theapparatus10 to a greater or lesser extent with the first and second formingmembers20,22. For example, to create thewire form44 shown inFIG. 14, the first and second formingmember20,22 may be moved greater distances after their respectivewire engaging surfaces24,34 have engaged thewire12, as compared to the distances travelled by the first and second formingmembers20,22 after thewire engaging surfaces24,34 have engaged thewire12 to form the wire form42 illustrated byFIG. 13. Of course, many other shapes may be formed and the embodiments illustrated inFIGS. 13 and 14 are not intended to be limiting in any way.
For example, because the movement of thewire12, the first formingmember20, and the second formingmember22 are controlled by thecontroller30, 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 anapparatus100 for forming a wave form for a stent from thewire112. Like the embodiment illustrated inFIGS. 1-12, thewire112 is provided to theapparatus100 by asupply114, which may include a spool upon which thewire112 is wound. Thewire112 may be fed in thefirst direction 1D into aninlet115 of awire forming area116 of theapparatus100. As illustrated, thewire112 extends through thewire forming area116 substantially along an axis, and exits thewire forming area116 via anoutlet117. Asuitable clamp118 may be located just outside thewire forming area116, as illustrated, or may be located within thewire forming area116. The illustrated embodiment is not intended to be limiting in any way. Theclamp118 is configured to clamp thewire112 so that tension may be applied to thewire112 as thewire112 is formed into a predetermined shape, as discussed in further detail below.
Theapparatus100 also includes a plurality of first formingmembers120 and a plurality of second formingmembers122, each of which being located within thewire forming area116. As illustrated, the first formingmembers120 are located on one side of thewire112 and the second formingmembers122 are located on an opposite side of thewire112 as compared to the first formingmembers120. The first formingmembers120 and the second formingmembers122 have substantially elongated shapes, similar to the first and second formingmembers20,22 described above.
Each of the first formingmembers120 includes awire engaging surface124 that is configured to engage and thewire112 when the first formingmembers120 are moved in asecond direction 2D′ that is substantially orthogonal to thefirst direction 1D. After thewire engaging surfaces124 have engaged thewire112, the first formingmembers20 continue to move in thesecond direction 2D′ to deform thewire112, as shown inFIG. 16.
Each of the first formingmembers120 may be moved in thesecond direction 2D′ by a respectivefirst actuator126, all of which may be configured to move in thefirst direction 1D along a suitable structure, such as arail128 in a similar manner as described above with respect to thefirst actuator26 andrail28. Each of thefirst actuators126 may be in communication with a controller130 (as shown inFIG. 20) that is programmed to determine the X-Y position of each of the first formingmembers120 relative to thewire112 at any given time. Thecontroller130 is configured to signal thefirst actuators126 to move the first formingmembers120 to the desired coordinates within thewire forming area116.
Similarly, each of the second formingmembers122 includes awire engaging surface134 that is configured to engage thewire112 when the second formingmembers122 are moved in athird direction 3D′. After thewire engaging surfaces134 have engaged thewire112, the second formingmembers122 continue to move in thethird direction 3D′ to deform thewire112, as shown inFIG. 16. When the desired deformation is obtained, movement of the second formingmembers122 in thethird direction 3D′ is stopped and thewire112 is momentarily held in place by the first formingmembers120 and the second formingmembers122.
In an embodiment, all of thewire engaging surfaces124 of the first formingmembers120 have substantially the same shape, and thewire engaging surfaces134 of the second formingmembers122 have substantially the same shape, and also have substantially the same shape as thewire engaging surfaces124 of the first formingmembers120. In an embodiment, the shapes of thewire engaging surfaces124 of the first formingmembers20 and thewire engaging surfaces134 of the second formingmembers122 are different. In an embodiment, each of thewire engaging surfaces124,134 are different. The illustrated embodiment is not intended to be limiting in any way.
As illustrated inFIG. 16, thefirst actuators126 move the first formingmembers120 in thefirst direction 1D as well as thesecond direction 2D′. At substantially the same time, thesecond actuators136 move the second formingmembers122 in thefirst direction 1D as well as thethird direction 3D′ so that thewire112 is engaged by thewire engaging surfaces124,134 at about the same time. In an embodiment, thewire engaging surfaces124 of the first formingmembers120 engage thewire112 before thewire engaging surfaces134 of the second formingmembers122 engage thewire112. In an embodiment, thewire engaging surfaces134 of the second formingmembers122 engaging thewire112 before thewire engaging surfaces124 of the first formingmembers120. In an embodiment, each of the first formingmembers120 and the second formingmembers122 may be actuated at different times so that the respectivewire engaging surfaces124,134 engage thewire112 at different times. Thecontroller130 may be programmed so that the desired sequence of actuations may occur to create the desired wave form in thewire112.
For example, in an embodiment, the first formingmember120 that is closest to theclamp118 may be actuated first, and the second formingmember122 that is closest to theclamp118 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 theinlet115 of thewire forming area116 is actuated. All of the formingmembers120,122 may be retracted from thewire112 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 theinlet115 is aligned with the first forming member that is closest to theclamp118. The sequence may repeat itself, starting with the first forming member engaging the already formed portion of the wire form. Thesupply114 may be configured to automatically advance thewire112 as thewire112 is deformed into the wave form, as long as a slight tension is maintained on thewire112 so that thewire112 remains straight within thewire forming area116 until it is deformed.
As illustrated inFIG. 17, after a wave form140 has been formed, the first formingmembers120 may be moved in thethird direction 3D′ to disengage from thewire112, and the second formingmembers122 may be moved in thesecond direction 2D′ to disengage from thewire112. Thecontroller130 may then signal theclamp118 to open and may signal thesupply114 to advance the wire112 a predetermined amount so that a new section ofwire112 may be advanced into thewire forming area116, as shown inFIG. 18. At about the same time, the first and second formingmembers120,122 may be moved along theirrespective rails128,138 in thefourth direction 4D so that another cycle may begin. Once theclamp118 is closed, the process may be repeated until the desired amount ofwire112 has been formed into the desired wave form.
For example, because the movement of thewire112, the first formingmembers120, and the second formingmembers122 are controlled by thecontroller130, 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 thecontroller30 and other parts of theapparatus10 that are illustrated inFIGS. 1-12. As illustrated, thecontroller30 is configured to communicate with thesupply14, theclamp18, thefirst actuator26, and thesecond actuator36. As discussed above, thefirst actuator26 is configured to move the first formingmember20 in both X and Y directions (using the coordinates depicted inFIG. 1). Similarly, thesecond actuator36 is configured to move the second formingmember22 in both X and Y directions. Once the desired wave form has been communicated to thecontroller30, and thecontroller30 is able to access a computer readable medium that contains a method for forming the desired wave form, as described herein, thecontroller30 may signal thesupply14, theclamp18, thefirst actuator26, and thesecond actuator36 so that theapparatus10 forms the desired wave form. Although a particular sequence of movement of the formingmembers20,22 is described above, other sequences may be programmed for execution by the controller. For example, in an embodiment, the second formingmember22 may be moved prior to the first formingmember20.
FIG. 20 schematically illustrates communication between thecontroller130 and other parts of theapparatus100 that are illustrated inFIGS. 15-18. As illustrated, thecontroller130 is configured to communicate with thesupply114, theclamp118, thefirst actuators126, and thesecond actuators136. As discussed above, thefirst actuators126 are each configured to move a corresponding first formingmember120 in both X and Y directions (using the coordinates depicted inFIG. 15). Similarly, thesecond actuators136 are each configured to move a corresponding second formingmember122 in both X and Y directions. Once the desired wave form has been communicated to thecontroller130, and thecontroller130 is able to access a computer readable medium that contains a method for forming the desired wave form, as described herein, thecontroller130 may signal thesupply114, theclamp118, thefirst actuators126, and thesecond actuators136 so that theapparatus100 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.