Stent holding fixtures
09908138 · 2018-03-06
Assignee
Inventors
- Isaac Rodriguez-Mejia Plans (Galway, IE)
- Javier Palomar Moreno (Galway, IE)
- Tomás Madden (Galway, IE)
- David O'Neill (Galway, IE)
- Victoria May Gong (Sunnyvale, CA, US)
Cpc classification
B05B13/0235
PERFORMING OPERATIONS; TRANSPORTING
B05B13/0442
PERFORMING OPERATIONS; TRANSPORTING
B05B12/04
PERFORMING OPERATIONS; TRANSPORTING
B05C13/025
PERFORMING OPERATIONS; TRANSPORTING
International classification
B05B12/04
PERFORMING OPERATIONS; TRANSPORTING
B05B13/04
PERFORMING OPERATIONS; TRANSPORTING
A61F2/82
HUMAN NECESSITIES
Abstract
Disclosed are stent holding devices having a support mandrel and one or more stent retaining fixtures disposed on the mandrel. The retaining fixture may include a character identifier to facilitate tracking a stent mounted on the holding device. The retaining fixture may include a conical protrusion and a conical recess to allow any number of retaining fixtures to engage each other and be stacked on the mandrel. The retaining fixture may include a tubular member having a spiral cut that enables the diameter of the tubular member to be adjusted to allow for a frictional fit on the mandrel. The retaining fixture may have a Z-shaped or T-shaped structure configured to retain a stent. The stent retaining fixture may also have a filament for retaining a stent.
Claims
1. A stent holding device comprising: a support mandrel sized to fit in a stent lumen of a stent; and a plurality of fixtures, each fixture configured to be selectively mounted on and removed from the support mandrel, each fixture including a forward facing surface and a rearward facing surface, the forward facing surface having a protruding conical surface that is sloped relative to a longitudinal axis of the support mandrel to allow the protruding conical surface, when exposed, to support an edge of the stent while the support mandrel extends through the stent lumen, the rearward facing surface having an aperture having a conical recess that is configured to receive the protruding conical surface of another one of the plurality of fixtures.
2. The stent holding device of claim 1, wherein the support mandrel extends into and frictionally engages the aperture of each of the plurality of fixtures.
3. The stent holding device of claim 1, wherein at least one of the plurality of stent retaining fixtures includes a character identifier, barcode, machine readable graphic, or RFID device.
4. The stent holding device of claim 1, further comprising a luer attached to one end of the support mandrel.
5. The stent holding device of claim 1, wherein a first fixture and a second fixture of the plurality of fixtures are arranged on the support mandrel such that the protruding conical surface of the second fixture extends into the conical recess of the first fixture, and the protruding conical surface of the first fixture is exposed to allow the protruding conical surface of the first fixture to support the edge of the stent while the support mandrel extends through the stent lumen.
6. The stent holding device of claim 5, wherein the first fixture is movable relative to the second fixture while the first and second fixtures are both on the support mandrel such that the first fixture can be selectively separated from the second fixture and brought closer to the second fixture to allow the first and second fixtures to engage each other.
7. The stent holding device of claim 5, wherein the first and second fixtures are stacked together on the support mandrel such the first fixture keeps the stent from contacting the second fixture.
8. The stent holding device of claim 5, wherein the protruding conical surface of the second fixture and the conical recess of the first fixture have corresponding shapes that allow the first fixture to engage the second fixture.
9. The stent holding device of claim 5, wherein a third fixture of the plurality of fixtures is arranged on the support mandrel such that the protruding conical surface of the third fixture extends into the conical recess of the second fixture, and the second fixture is disposed between the first and third fixtures.
10. The stent holding device of claim 9, wherein the first, second, and third fixtures are stacked together such the first fixture keeps the stent from contacting the second and third fixtures.
11. The stent holding device of claim 9, wherein the second fixture is movable relative to the third fixture while the second and third fixtures are both on the support mandrel, and the second fixture can be selectively separated from the third fixture and brought closer to the third fixture to allow the second and third fixtures to engage each other.
12. The stent holding device of claim 9, wherein when the third fixture is on the support mandrel, the first and second fixtures are capable of being removed from the support mandrel to expose the protruding conical surface of the third fixture to allow the exposed protruding conical surface of the third fixture to support the edge of the stent while the support mandrel extends through the stent lumen.
13. The stent holding device of claim 5, wherein when the second fixture is on the support mandrel, the first fixture is capable of being removed from the support mandrel to expose the protruding conical surface of the second fixture to allow the exposed protruding conical surface of the second fixture to support the edge of the stent while the support mandrel extends through the stent lumen.
14. The stent holding device of claim 1, wherein each fixture, when mounted on the support mandrel, is movable relative to an adjacent one of the fixtures on the support mandrel and in a direction along the longitudinal axis of the support mandrel.
15. The stent holding device of claim 1, wherein the support mandrel has a first end segment and a second end segment, the plurality of fixtures are arranged on the first end segment, and the protruding conical surface of the fixture nearest the second end segment of the support mandrel is exposed to allow the exposed protruding conical surface to support the edge of the stent while the support mandrel extends through the stent lumen.
16. The stent holding device of claim 15, wherein the fixture nearest the second end segment of the support mandrel keeps the stent separated and out of contact from the other fixtures of the plurality of fixtures.
17. The stent holding device of claim 1, wherein an exterior width of each fixture, as measured in a direction perpendicular to the longitudinal axis of the support mandrel, is the same as that of an adjacent one of the fixtures on the support mandrel.
18. The stent holding device of claim 1, wherein when the plurality of fixtures are stacked together on the fixture with all forward facing surfaces facing in the same direction, only one of the fixtures is capable of making contact with the stent while the support mandrel extends through the stent lumen.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
(12) The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
(13) In accordance with the present invention there is provided an exemplary embodiment of a stent holder or mandrel in accordance with the present invention. The stent holder in accordance with the present invention includes a support member and at least two stent receiving fixtures radially disposed about the support member, the receiving fixtures configured to retain a stent radially about the support member.
(14) Referring now to
(15) The support mandrel 13 may be embodied in the form of a needle having a luer fitting on one end and a shaft, wherein the shaft of the support mandrel 13 may be constructed of metal or plastic. Preferably the material of which the support mandrel is constructed is relatively stiff and resistant to bending loads. Additionally, it is preferred that the support mandrel be constructed of a material which is chemically compatible with the coating to be applied to the stent. Also, it is desirable that the mandrel be resistant to extreme temperatures, either extreme cold or extremely hot temperatures without breaking.
(16) The support mandrel 13 is constructed having a generally circular cross-sectional profile, though other cross-sectional geometries may be utilized. For example, a section of the support mandrel 13 disposed between the stent receiving fixtures 15 may be cylindrical wherein the sections of the support mandrel 13 under the stent receiving fixtures may have a different cross-sectional profile which may function as an indexing feature or locking feature for the stent receiving fixture. For example, the section of the support mandrel 13 configured to receive the stent receiving fixtures 15 may have a star-shaped cross-sectional profile (
(17) The stent receiving fixtures 15 as shown in
(18) The stent receiving fixtures 15 have an aperture disposed therethrough, wherein the aperture is sized to receive the support mandrel 13. As described above, the aperture and the support mandrel 13 may be shaped to provide an indexing feature. Additionally, the aperture disposed through the receiving fixtures 15 may be a tapered aperture, thereby causing the stent receiving fixtures to be frictionally engaged with the support mandrel 13.
(19) The stent receiving fixtures 15 may be constructed of plastics such as Delrin, PVC, nylon or similar materials or constructed of metal such as stainless steel, aluminum, steel, titanium or other similar metals. Additionally, the surface finish of the fixtures may range from a rough surface to a highly polished surface.
(20) In use, a first stent receiving fixture would be disposed upon the support mandrel, a stent would then be disposed radially about the support mandrel, the second stent receiving fixture is then placed onto the mandrel. The stent is supported on its ends by the sloped faces of each of the stent receiving fixtures. The support mandrel 13 may then be mounted into a spraying apparatus where the entire assembly may be rotated while being sprayed.
(21) In some instances due to regulatory requirements it is necessary to track specific stents through the entire manufacturing process, wherein a serial number containing lot information about the beneficial agent is placed on the products finished label. The holder shown and described in
(22) Referring now to
(23) As shown in
(24) The fixtures 16 may be constructed of materials such as those described above with regard to the mandrel of
(25) Referring now to
(26) In use, the apertures 23 formed in the body of the fixture 20 allow for sprayed liquid coming in contact with the fixture 20 to pass through the apertures 23 of the fixture 20 instead of flowing around the fixture 20 and potentially onto the end of the stent being coated.
(27) The fixture 20 may be formed of a metallic tubular member, wherein the fixture may be formed through laser cutting. It is also contemplated that the spacer be formed of the materials such as those described above.
(28) Referring now to
(29) As shown in
(30) The fixture 30 is configured to be disposed radially about a support mandrel 13 as described above with regard to the mandrels in accordance with the present invention. As shown in
(31) As shown in
(32) The fixture 30 as described above, can be expanded in diameter to fit tightly about the support mandrel 13 in order to position a stent 5 on the mandrel as shown in
(33) In a preferred embodiment, the diameter of the fixture 30 is less than that of the support mandrel 13. Therefore, the diameter of the fixture must be expanded in order to dispose the fixture over the support mandrel 13, thereby ensuring a friction fit between the fixture 30 and the support mandrel 13.
(34) Referring now to
(35) Referring now to
(36) Referring now to
(37) Unlike the previously described mandrels, the mandrel in accordance with the present embodiment does not include a separate or integrated fixture as described above in connection with
(38) As shown in
(39) As shown in
(40) As shown in
(41) As shown in
(42) As shown in
(43) In accordance with each of the embodiments described above with regard to
(44) In other embodiments, the number of contact points can be more or less than the number of contact points shown in
(45) Referring now to
(46) Referring now to
(47) In
(48) The left and right mandrel assemblies 75a, 75b each include a stent retaining fixture comprised of two components, a plurality of arms 72, 72 and a stent contacting member 73, 73 disposed between the two arms. The stent contacting member may be embodied in the form of a threaded member such as a piece of suture, or a metallic member such as a wire or other similar types of materials that may be disposed between the two arms 72, 72. The stent contacting member 73, 73 may also be configured to be easily removed from the arms 72, 72, wherein the stent contacting member 73, 73 may be replaced after a process has been performed on the stent to reduce the possibility of contamination or failure. The arms 72, 72 are attached to a shaft member 71, 71 which is supported by a housing 74 as shown.
(49) The right mandrel assembly 75a further includes a drive mechanism configured to provide rotational movement to the shaft member 71. Additionally, the shaft member 71 of the right mandrel assembly may further include an aperture disposed therethrough, wherein a support mandrel 13 may be disposed therethrough to aid in loading a stent between the two mandrel assemblies 75a, 75b.
(50) The left mandrel assembly 75b further includes a drive mechanism coupled to the shaft member 71 and configured to provide rotational motion to the shaft member 71. The left mandrel assembly 75b further includes a linear drive mechanism 77 coupled to the shaft member 71, wherein the linear drive mechanism is utilized to adjust the distance between the left mandrel assembly and the right mandrel assembly when stent 5 is placed between the two assemblies 75a, 75b. As shown in
(51) In use the stent 5 is placed between the left mandrel assembly 75b and the right mandrel assembly 75a, a support mandrel 13 is advanced through an aperture in the right mandrel assembly 75a and through the stent 5, wherein the distal end of the support mandrel 13 is received by the shaft 71 of the left mandrel assembly 75b. The distance between the two mandrel assemblies 75a, 75b is adjusted by moving the left mandrel assembly 75b, wherein the ends of the stent 5 are supported by the stent contacting members 73, 73. The support mandrel 13 is then removed from the lumen of the stent and the right mandrel assembly 75a. Each of the rotational drive assemblies are then engaged to provide rotation to the mandrel assemblies and the stent. Preferably, the rotational drive assemblies are coupled together, thereby providing uniform rotational motion to the stent retained between the two mandrel assemblies.
(52) It shall be understood that the arms 72, 72 and the stent contacting members 73, 73 may be replaced by any of the other mandrels in accordance with the above embodiments shown and described herein with reference to the present invention.
(53) Although the mandrels and methods of use in accordance with the present invention have been described in accordance with stent coating, it will be understood by one of ordinary skill in the art that the mandrels in accordance with the present invention may be utilized for other purposes. For example, the mandrels may be utilized during electropolishing procedures, manufacturing procedures, storage or for similar purposes.
(54) Referring again to
(55) In addition to or as an alternative to a character identifiers, the fixtures 16 may include barcodes, other machine readable graphics, or RFID devices embedded in or mounted on the fixtures 16. The use of a character identifier, such as a numeral, has the advantage of being readily recognizable by persons handling the stent without the aid of barcode reading devices, RFID scanners, or other machines.
(56) As shown in
(57) The ability to add and remove fixtures 16 also facilitates mounting more than one stent on the stent holding device. For example, two fixtures 16 may be used to separate two stents disposed on the support mandrel 13. The two fixtures can be oriented in opposite directions such that their respective sloped surface faces toward and engages an adjacent stent edge.
(58) Referring again to
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(60) Referring once again to
(61) Referring again to
(62) The stent holding apparatus 70 optionally includes a support mandrel 13 sized to fit into a stent lumen and disposed between the first and second end regions 140, 142. In the illustrated embodiment, a portion of the support mandrel 13 extends from the first end region 140 and beyond the second end region 142. The support mandrel 13 is movable in longitudinal directions 150 through an aperture 148 formed in each of the fixtures 144, 146.
(63) Still referring to
(64) In
(65) A linear drive mechanism 77, which can comprise gears 152, is coupled to the first stent retaining fixture 144 such that the fixture is translated linearly in a longitudinal direction when the linear drive mechanism is activated. A rotational drive mechanism 154 is coupled to the first and second stent retaining fixtures 144, 146 such that the stent retaining fixtures are rotated when the rotational drive mechanism is activated.
(66) While several particular forms of the invention have been illustrated and described, it will also be apparent that various modifications can be made without departing from the scope of the invention. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.