|Numéro de publication||US20060248698 A1|
|Type de publication||Demande|
|Numéro de demande||US 11/122,397|
|Date de publication||9 nov. 2006|
|Date de dépôt||5 mai 2005|
|Date de priorité||5 mai 2005|
|Autre référence de publication||CA2607689A1, EP1901679A1, WO2006121787A1|
|Numéro de publication||11122397, 122397, US 2006/0248698 A1, US 2006/248698 A1, US 20060248698 A1, US 20060248698A1, US 2006248698 A1, US 2006248698A1, US-A1-20060248698, US-A1-2006248698, US2006/0248698A1, US2006/248698A1, US20060248698 A1, US20060248698A1, US2006248698 A1, US2006248698A1|
|Inventeurs||Brian Hanson, Wade Johnson, Kenneth Merdan|
|Cessionnaire d'origine||Hanson Brian J, Johnson Wade M, Merdan Kenneth M|
|Exporter la citation||BiBTeX, EndNote, RefMan|
|Citations de brevets (80), Référencé par (13), Classifications (17), Événements juridiques (1)|
|Liens externes: USPTO, Cession USPTO, Espacenet|
This invention generally relates to stents and methods of making a stent from a tubular member for placement within a body lumen or interior space of a body during a medical procedure.
Stents are expandable endoprosthetic devices adapted to be placed in a body lumen in order to maintain the patency of a body lumen by providing a flow pathway and/or structural support, for example. Stents are typically used in the treatment of atherosclerotic stenosis in blood vessels and the like to reinforce body vessels and to prevent restenosis following angioplasty in the vascular system. Additionally, stents may be used in the treatment of aortic aneurysms, by providing strength to a weakened vascular wall. They have also been implanted in other body lumens, such as urinary tracts and bile ducts. Stents are generally tubular structures that may be radially expandable between an unexpanded size and an expanded size greater than the unexpanded size. Therefore, a stent may be inserted through a body lumen in an unexpanded state and then expanded at a specific location within the lumen to an expanded state.
As the use of stents in a variety of medical procedures is gaining widespread acceptance, it is desirable to provide improved methods of manufacturing stents in order to increase efficiency, reduce costs, and/or minimize material waste. The disclosed stents and accompanying methods of manufacturing a stent may be deemed advantageous in view of the increased usage of stents during medical procedures.
The invention is directed to a stent manufactured from a tubular member. The stent may be cut from a tubular member such that a pattern and an opening extending from the first end to the second end of the tubular member are cut therein. The opening may define a first edge and a second edge through the wall of the tubular member. One or more connectors may be cut along either the first or second edge and may extend into the opening.
Accordingly, a process of making a stent from a tubular member is disclosed. A tubular structure having a pattern configured to provide expansion and an opening defining a first edge and a second edge may be cut from a tubular member. The opening may be cut such that one or more connectors may be cut along either the first or second edge and extend into the opening.
The invention may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The detailed description and the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. The illustrative embodiments depicted are intended only as exemplary. Selected features of any illustrative embodiment may be incorporated into an additional embodiment unless clearly stated to the contrary.
Referring now to the drawings, and particularly
Now referring to
One or more connectors 40 may be cut along the first edge 32 and extend into the opening 30. Additionally or alternatively, one or more connectors 40 may be cut along the second edge 34 and extend into the opening 30. Connectors 40 may be positioned adjacent one another and extend from opposing edges 32, 34 of the tubular member 50, or connectors 40 may be alternated along at least a portion of the length of the opening 30. A connector 40 may extend from the first edge 32 toward the second edge 34 and be attached to a connector 40 extending from the second edge 34 toward the first edge 32, thus creating one continuous connector 40 spanning the opening 30 between the first edge 32 to the second edge 34. Alternatively, opposing connectors 40 may not be attached to one another, thus a space may remain between opposing connectors 40.
Referring now to
As a result of the expansion of the tubular structure 70, connectors 40 may become elongated. Connectors 40 may provide support and/or continuous structure in order to ensure uniform, non-uniform or an otherwise predetermined expansion of the tubular structure 70. Therefore, the tubular shape of the structure 70 may be maintained throughout the expansion process. For example, connectors 40 may be configured to have a degree of expansion similar to that of the pattern 60. Therefore, the circumferential expansion of the tubular structure 70 may be uniform at all locations around the circumference of the tubular structure 70. Connectors 40 may be configured to provide visual confirmation of proper expansion, such as when the connectors 40 are sufficiently straightened. Therefore, the tubular structure 70 may reach its proper expanded dimensions when the connectors 40 have reached a sufficient elongated configuration. Alternatively, connectors may be configured to provide visual confirmation of proper expansion of the tubular member 50 at the point where elongation of connectors 40 commences or at the point of fracture of connectors 40 from tubular member 50.
Connectors 40 may be sufficiently frangible such that connectors 40, or a portion thereof, may be separated from the tubular structure 70 subsequent expansion of the tubular structure 70, or connectors 40 may be retained with the tubular structure 70. Connectors 40 may be removed during a subsequent process using mechanical, electrical or chemical techniques. A cutting process may be used to provide separation from the edge 32, 34 of the structure 70. For example, a laser ablation technique may be used to separate the connectors 40 from the tubular structure 70 or weaken the interface between connector 40 and tubular structure 70. Connectors 40 may be removed by mechanically cutting, snipping, breaking or otherwise severing the connectors, or by grinding, sandblasting or otherwise eroding away material. Additionally or alternatively, a chemical etching or electro-polishing process may be used to remove connectors 40 or a portion thereof. Connectors 40 may be dissolved or weakened during a subsequent manufacturing process in which a portion of the material is eroded away.
Alternatively or additionally, a wire or filament may be extend between connectors 240 to join opposing or alternating connectors. For example, the wire may be laced or threaded through holes 244 of connectors 240. The wire may be a temporary connector which extends across opening 230. The wire may substantially restrain separation of opposing edges 232, 234 or tubular structure 270. The wire may provide support and/or continuous structure to the tubular member 250 to ensure uniform, non-uniform or an otherwise predetermined expansion of the tubular structure 270. Therefore, the tubular shape of the structure 270 may be maintained throughout the expansion process. Subsequent expansion and/or forming of the tubular structure 270, the wire may be removed from the structure 270. The wire may be removed by mechanical, electrical or chemical means. The wire may be dissolvable whereby it is dissolved with a solvent, by a thermal process, a chemical process or an electrical process. The wire may have characteristics similar to a dissolvable suture. Alternatively, wire may be mechanically removed by a laser, grinding, sandblasting, cutting, snipping, etching, breaking, or by another process.
Additionally or alternatively, connectors, such as connectors 240, having an aperture such as a recess, may include an adhesive. The adhesive, which may be disposed in the recess of the connector 240, may be used to secure one portion of the tubular structure 270 with another portion of the tubular structure 270. For example, one connector 240 may be adhesively secured to an opposing connector 240. The adhesive may also be used to secure the tubular structure 270 to another apparatus for forming and/or processing of the tubular structure 270. The adhesive may be dissolvable, or otherwise provide temporary securement, or the adhesive may be intended to provide permanent securement.
Alternatively or additionally, an apparatus such as a mandrel having hooks, tines, clips, or other engagement means, may be used to engage connectors 240. The mandrel may substantially couple opposing edges 232, 234 such that edges 232, 234 are restrained from separation during expansion of the tubular structure 270. For example, the hooks of the mandrel may be inserted in holes 244 of connectors 240. The mandrel may provide support and/or continuous structure to the tubular member 250 to ensure uniform, non-uniform or an otherwise predetermined expansion of the tubular structure 270. Therefore, the tubular shape of the structure 270 may be maintained throughout the expansion process. Subsequent expansion and/or forming of the tubular structure 270, the mandrel may be removed from the structure 270. Although the mandrel may engage connectors 240, mandrel may also engage another portion of the stent to restrain separation of opposing edges 232, 234.
Connectors 240, characterized as tooling nodes as shown in
Any one of the previously disclosed tubular structures may further be rolled into a coil stent. As shown in
Alternatively, one of the previously disclosed tubular structures may be formed in a C-shape such as shown in
Any one of the previously described stent forming processes may include one or more further processing steps. For example, the tubular member may be subjected to a cleaning process to remove dross or residue subsequent a cutting process. For instance, an alcohol and/or water solution may be used to clean foreign material from the tubular structure. A chemical etching process may be used to remove connectors and/or other material from the tubular structure to provide a surface with no sharp edges or burrs. An electro-polishing process may be used to reduce the surface roughness of the machined tubular member and provide a stent having a substantially smooth outer surface. An electro-polishing process, or similar electrical process, may also be used to dissolve or otherwise separate a connector from the stent. For example, an electro-polishing process may dissolve a percentage of the mass of the material forming the stent. By dimensioning the connectors relatively small compared to the material of the interconnected segments of the stent, the connectors will completely dissolve, erode or otherwise be separated from the stent without fully dissolving the interconnected segments during an electro-polishing process. An electrical current of a sufficient magnitude may be applied to the connectors to separate the connectors from the stent. Additionally, a stent may be subjected to one or more heat treating processes in order to remove residual stresses and/or provide favorable characteristics to the stent, such as shape memory properties.
One illustrative stent forming process may include a plurality of processes. Initially a stent may be laser cut from a tubular member as discussed above. The stent may then be subjected to a chemical etching and/or electro-polishing process to remove residue, connectors and/or rough edges remaining after being cut from the tubular member. Alternatively or additionally, the stent may be placed in an ultrasonic cleaning process. Next, the stent may be expanded or otherwise formed by rolling and/or tucking the ends of the stent. Once formed, the stent may be heat treated to remove any residual stresses and/or provide shape memory properties and then quenched. The stent may then undergo a final cleaning process to remove any remaining residue. Additional processes, such as chemical etching, electro-polishing, cleaning or heat treating, may be included throughout. For example, the stent may be subjected to a chemical etching or electro-polishing process subsequent to being expanded in order to remove temporary connectors from the stent.
It is contemplated that the disclosed process of forming a stent may be substantially used to form other similar products from a tubular member. For example, a filter mesh or frame for an intravenous filter or distal protection device may be formed utilizing the disclosed process.
Those skilled in the art will recognize that the present invention may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departure in form and detail may be made without departing from the scope and spirit of the present invention as described in the appended claims.
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|Classification aux États-Unis||29/282|
|Classification internationale||A61F2/92, B21D39/04|
|Classification coopérative||Y10T29/53987, A61F2/91, A61F2002/9155, A61F2002/91558, A61F2/915, A61F2002/91591, A61F2/92, A61F2230/0013, A61F2220/005, A61F2002/9511, A61F2002/91541|
|Classification européenne||A61F2/91, A61F2/915, A61F2/92|
|25 mai 2005||AS||Assignment|
Owner name: BOSTON SCIENTIFIC SCIMED, INC., MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:JOHNSON, WADE M.;HANSON, BRIAN J.;MERDAN, KENNETH M.;REEL/FRAME:016060/0462;SIGNING DATES FROM 20050428 TO 20050503