Adjustable Support For Tubular Medical Device Processing

BACKGROUND OF THE INVENTION

00011. Field of the Invention

0002The present invention relates to drug-eluting medical devices; more particularly, this invention relates to support structure for medical devices. The support structure is used to support the medical device during processing of the medical device, in particular, when a coating is applied to the medical device.

00032. Background of the Invention

0004Stents are often modified to provide drug delivery capabilities to further address thrombosis and restenosis. Stents may be coated with a polymeric carrier impregnated with a drug or therapeutic substance. A conventional method of coating includes applying a composition including a solvent, a polymer dissolved in the solvent, and a therapeutic substance dispersed in the blend and applied to the stent by immersing the stent in the composition or by spraying the composition onto the stent. The solvent is allowed to evaporate, leaving on the stent strut surfaces a coating of the polymer and the therapeutic substance impregnated in the polymer. Depending on the application and volatility of the solvent, forced air drying may also be used to remove the solvent from the coating and arrive at a desired release rate for the impregnated therapeutic agent into the body.

0005It is known that some methods for coating stents do not produce an ideal, or defect-free coating over a surface of the stent where the therapeutic agent is intended to take effect. Coating defects may include non-uniform surface characteristics, such as bare spots and flaking. Coating defects can also serve as an initiation site for later-developed peeling or flaking that produces embolic debris. Rough surfaces generated by, and stagnant regions of blood flow produced by nearby flaps or packets formed by coating defects can serve as a nidus for thrombus formation. Furthermore, coating defects produce variations in the intended amount, concentration, and release rate of the drug from the stent coating, further complicating or minimizing the effectiveness of therapeutic agents.

0006Methods for spray coating a stent with polymer-drug dissolved in a solvent include mounting the stent on a mandrel to support and rotate the stent while it is being sprayed with the drug-polymer composition. Examples of prior mandrel designs constructed for this purpose are disclosed in U.S. Pub. No. 2007/0259100.

0007A support mandrel is used to hold and keep track of stents during processing. Since stents of a particular type will have different lengths or diameters, several different mandrels are needed to accommodate different stent sizes. Additionally, differently sized mandrels are needed to support different diameter stents as they are being tested or evaluated. It is desirable to have a mandrel that could be adjusted to support stents of different sizes. Many of the stent-supporting mandrels previously proposed can be adjusted to support stents of different lengths. What is needed, however, is a mandrel that can be readily adjusted to support stents of different diameters and lengths, or to adjust the amount of support needed for a stent during testing so that a single mandrel can be used to support a wider variety of stents.

0008In view of the foregoing, there is a need for a mandrel assembly that provides minimal contact to reduce coating defects during spraying while being adjustable to offer a variable amount of support for stents having a range of different diameters as well as lengths.

SUMMARY OF THE INVENTION

0009The invention improves on the art by providing an apparatus and method for applying a coating composition to a surface of a tubular medical device, e.g., a stent or scaffold, using an assembly including a rod that can be adjusted for different stent diameters, stent lengths, and/or to vary the amount of support for a stent without requiring an assortment of separate pieces for the mandrel.

0010In one aspect there is an assembly for supporting a stent during processing, e.g., inspection of the stent, spraying, weighing or drying to remove a solvent from the stent. The assembly includes a first rod extending between first and second members, e.g., first and second collets of a mandrel. A second rod also extends between the two members. This rod can be shaped to provide a support for stents having different diameters by rotating one of the members relative to the other member. When the desired diameter is found, the two members may be locked in rotation, or are capable of retaining their angular positions without the need to provide a locking mechanism, to provide the desired shape for supporting the stent. The shape may be a helix, a partial helix, or the rod may be shaped so that it at least partially circumscribes a longitudinal axis of the first rod. A partial helix means a shape following the path of a helix but traversing less than one full revolution, i.e., circumscribes less than one full circumference of a circle. A rod shaped into a partial helix means a rod that traverses more than about 90 degrees, or between about 90 and 180 degrees, or between about 180 and 270 degrees, or between 270 degrees and less than 360 degrees.

0011According to another aspect of the invention, a support assembly for a tubular medical device includes first and second collets and a first and second rod extending there between. The second collet includes a collar and a housing adapted for being rotated about the collar. The first rod passes through the collar and the second rod passes through the housing. A gear mechanism is formed between the collar and housing. When the housing is clocked about the collar in fixed angular increments, the second rod may be shaped into different helix shapes. There may be a third rod that also passes through the housing. In this embodiment rotation of the housing forms parallel helix forms for supporting the medical device.

0012According to one embodiment, an apparatus includes first and second collets and a first and second rod extending between and connected to the collets. The first rod has a longitudinal axis. And the second collet includes a collar receiving the first rod, and a housing receiving the second rod, mounted upon the collar and adapted for being rotated about the collar, wherein the first rod is capable of being formed into a full or partial helix for supporting a medical device between the collets when the housing rotates about the collar.

0013According to another embodiment, a method of making a support for a tubular medical device includes the steps of disposing the medical device on a rod extending between first and second members and while the medical device is disposed on the rod, rotating the second member relative to the first member to form the second rod as a full or partial helix for supporting the medical device. The second member may include a gear mechanism, or collar and sleeve to provide a clocked rotation about a rotation axis, or it may have only a central passage for the first rod. The second member is rotated about the first rod to shape the second rod. After the desired shape has been made, the second member is fixed to the first rod. Alternatively, the first rod may be fixed to the second member and the first member free to rotate about the first rod to shape the second rod into a full or partial helix. After the desired shape is made, the first member is fixed to the first rod.

0014According to another embodiment, a method for supporting a medical device includes disposing the medical device between a first and second member, wherein a first and second rod extend through the bore of the stent. The first and second rods are coupled to the first and second members. The first member is held in one hand and the second member is held in the other hand. The second member is rotated relative to the first member to shape the first rod as a support for the stent. After the first rod is shaped, the first and second members are fixed in rotation to the second rod to maintain the shape in the first rod.

0015According to another embodiment, a method for supporting a second medical device (MD) includes the steps of providing a first MD on a mandrel, the mandrel having a first collet, second collet and a rod extending there between, the rod providing a support for the first MD at about the same diameter as an inner diameter of the first MD; removing the first MD from the rod; placing the second MD on the rod; and shaping the rod to provide a support for the second MD at about the same diameter as an inner diameter of the second MD including rotating the second collet relative to the first collet.

0016According to another embodiment, a method of applying a coating composition to a medical device includes the steps of providing a medical device on a rod extending between a first and second member; while the medical device rests on the rod, forming the rod into a helix or partial helix by rotating the second member relative to the first member, the helix or partial helix supporting the medical device; locking the second member in rotation relative to the first member to maintain the rod as a helix or partial helix; rotating the medical device about an axis; and applying the coating composition to the rotating medical device.

INCORPORATION BY REFERENCE

0017All publications and patent applications mentioned in the present specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. To the extent there are any inconsistent usages of words and/or phrases between an incorporated publication or patent and the present specification, these words and/or phrases will have a meaning that is consistent with the manner in which they are used in the present specification.

BRIEF DESCRIPTION OF THE DRAWINGS

0018<figref idref="DRAWINGS">FIG. 1A</figref> is a side view of an assembly for supporting a tubular medical device according to the disclosure.

0019<figref idref="DRAWINGS">FIG. 1B</figref> is a top view of a portion of the assembly of <figref idref="DRAWINGS">FIG. 1A</figref> showing a collet used to form a rod of <figref idref="DRAWINGS">FIG. 1A</figref> into a shape for supporting medical devices of different diameters.

0020<figref idref="DRAWINGS">FIG. 1C</figref> is a side view of the assembly of <figref idref="DRAWINGS">FIG. 1A</figref> mounted to a spindle of a stent spraying and drying apparatus.

0021<figref idref="DRAWINGS">FIG. 2A</figref> is a front view of the collet of <figref idref="DRAWINGS">FIG. 1B</figref> as viewed from section IIA-IIA in <figref idref="DRAWINGS">FIG. 2B</figref>.

0022<figref idref="DRAWINGS">FIG. 2B</figref> is a side cross-sectional view of the collet of <figref idref="DRAWINGS">FIG. 1B</figref>, as viewed from section IIB-IIB in <figref idref="DRAWINGS">FIG. 1B</figref>.

0023<figref idref="DRAWINGS">FIG. 2C</figref> is a close-up of a portion of the collet of <figref idref="DRAWINGS">FIG. 2A</figref> showing an engagement between teeth formed on a sleeve and collar portion of the collet.

0024<figref idref="DRAWINGS">FIG. 3</figref> is a perspective view of the collar of the collet illustrated in <figref idref="DRAWINGS">FIGS. 1A-1C</figref>.

0025<figref idref="DRAWINGS">FIG. 4</figref> is a perspective view of the sleeve portion of a body of the collet adapted for being rotated relative to the collar of <figref idref="DRAWINGS">FIG. 3</figref>.

0026<figref idref="DRAWINGS">FIG. 5</figref> is a first arrangement of the assembly of <figref idref="DRAWINGS">FIG. 1A</figref> having the rod shaped to provide a support of length L<b>1</b> and diameter D<b>1</b> for a medical device. There is about one and one half revolutions of a helix formed in the rod.

0027<figref idref="DRAWINGS">FIG. 6</figref> is a second arrangement of the assembly of <figref idref="DRAWINGS">FIG. 1A</figref> having the rod shaped to provide a support of length L<b>2</b> and diameter D<b>1</b> for a medical device.

0028<figref idref="DRAWINGS">FIG. 7</figref> is a third arrangement of the assembly of <figref idref="DRAWINGS">FIG. 1A</figref> having the rod shaped to provide a support of length L<b>3</b> and diameter D<b>1</b> for a medical device. There are about two and one half revolutions of a helix formed in the rod.

0029<figref idref="DRAWINGS">FIG. 8</figref> is a fourth arrangement of the assembly of <figref idref="DRAWINGS">FIG. 1A</figref> having the rod shaped to provide a support of length L<b>2</b> and diameter D<b>2</b> for a medical device. Diameter D<b>2</b> is greater than diameter D<b>1</b>.

0030<figref idref="DRAWINGS">FIG. 9</figref> is a flowchart showing steps for assembling a stent support device according to another aspect of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

0031When spraying stents with a drug/polymer mixture it is critical to minimize the defects in the coating caused by the contact of the stent to the spraying mandrel on which it sits while being sprayed. When a drug eluting stent (DES) is implanted, coating defects can cause adverse reactions in the body. In addition, defective coatings can break off and form emboli, or protruding coating can be an initiation point for thrombus formation. Uncoated areas will not contain the intended drug, which can lead to restenosis.

0032A stent typically has a plurality of undulating, e.g., sinusoidal, ring structures that collectively provide a radial stiffness for the stent, and struts connecting the cylindrical elements. Lengthwise the stent is supported typically by only the flexural rigidity of slender-beam-like linking or connecting elements, which structure may give the stent a desired longitudinal flexibility. Examples of structure and surface topology of a stent are disclosed by U.S. Pat. Nos. 4,733,665, 4,800,882, 4,886,062, 5,514,154, 5,569,295, and 5,507,768. Additionally, this disclosure adopts the stent structure terminology of <figref idref="DRAWINGS">FIGS. 1-3</figref>, paragraphs [026] through [035], et seq. of U.S. application Ser. No. 12/554,671. The following description will refer to a stent supported on an assembly according to the disclosure, but it is understood that the assembly may be used to support a variety of tubular medical devices, including bioresorbable scaffolds.

0033Referring to <figref idref="DRAWINGS">FIGS. 1A and 1B</figref>, there is shown a side and partial top view, respectively, of an assembly for supporting a stent according to the disclosure. <figref idref="DRAWINGS">FIG. 1A</figref> shows the general dimensions (in phantom) of a tubular medical device, e.g., a stent, that can be supported on a helix-shaped supporting rod <b>1</b> according to the disclosure. Located at a proximal end of the assembly is a collet <b>11</b>. Located at a distal end of the assembly is a collet <b>10</b>. The rod <b>1</b> is attached to each of these collets. The collets <b>10</b>, <b>11</b> are fixed in position when maintaining the rod <b>1</b> helix shape. The collets <b>10</b>, <b>11</b> also provide abutting surfaces to maintain the stent's position between the collets <b>10</b>, <b>11</b> during processing or handling. Optionally, the collets <b>10</b>, <b>11</b> can also provide supporting surfaces for the stent's ends.

0034A second rod <b>5</b> extends along the rotation axis A (see <figref idref="DRAWINGS">FIG. 1C</figref>). The rod <b>5</b> is received in openings provided in each collet <b>10</b>, <b>11</b> for holding the rod <b>5</b>. As shown the collets <b>10</b>, <b>11</b> are spaced appropriately for the stent length and the diameter of the rod <b>1</b> helix chosen to provided a loose supporting surface along the luminal surface of the stent. In this configuration the rod <b>1</b> is formed into about a two and one-half revolution helix between the collets <b>10</b>, <b>11</b>. As explained in greater detail, below, the rod <b>1</b> may be adjusted to form more or less revolutions of a helix, or the diameter of the helix may be increased / decreased as desired to support the stent. This adjustment is done using the collet <b>10</b>.

0035A stent may be transported among processing, weighing or inspection stations using the assembly of <figref idref="DRAWINGS">FIG. 1A</figref>. <figref idref="DRAWINGS">FIG. 1C</figref> shows the assembly of <figref idref="DRAWINGS">FIG. 1A</figref> coupled to a spindle <b>70</b> with collet <b>10</b> supported on a cup or half-collar <b>60</b> that slides along a rail <b>62</b> (a rim <b>67</b> may be formed on collet so that half-collar <b>60</b> can move the assembly left or right in <figref idref="DRAWINGS">FIG. 1C</figref>). When applying a spray coating to the stent, an electric motor delivers a torque (T) through the spindle <b>70</b> to collet <b>11</b>, and thus the entire assembly shown in <figref idref="DRAWINGS">FIG. 1A</figref>. An attachment portion <b>11</b><i>a </i>of collet <b>11</b> includes suitable slots or other structure (not shown) for connecting the collet <b>11</b> via attachment portion <b>11</b><i>a </i>in rotation about axis A to the spindle <b>70</b>. The rod <b>5</b> connection between each collet <b>10</b>, <b>11</b> can be relied on to deliver the torque T from collet <b>11</b> to collet <b>10</b> and resist unwinding of the helix as it can be rotationally fixed to both collets.

0036A stent may be moved between a spraying and drying station one or more times to deliver several layers of a drug-polymer coating to the stent. In <figref idref="DRAWINGS">FIG. 1C</figref> the movement of the stent to/from a spraying or drying station is via displacement along axis A. The stent and assembly may be supported on the distal end for this movement, and/or during a spraying and drying, or drying-only cycle, using half-collar <b>60</b> that translates with the assembly and motor spindle <b>60</b> over the rail <b>62</b>. Alternatively, half-collar <b>60</b> is not used. Instead, gripper arms <b>200</b> are used to engage and support the distal end <b>5</b><i>a </i>of rod <b>5</b>. As indicated, gripper arms <b>200</b> extend up and down to grab the end <b>5</b><i>a </i>when the assembly is positioned over or under, respectively, the dryer or spray nozzle. Examples of grippers for a drying or spraying process are described in U.S. application Ser. No. 13/235,238 (docket no. 50623.1476). Alternatively, the assembly may be supported as a cantilever from the motor spindle <b>70</b>. The assembly is configured for rotation about axis A, which is collinear with longitudinal axis of rod <b>5</b>.

0037Referring again to <figref idref="DRAWINGS">FIG. 1A</figref>, the collet <b>11</b> may have a face <b>11</b><i>b </i>forming two slanted surfaces, as shown, for abutment with, or to support an end of the stent, as mentioned earlier. The stent-abutting face <b>12</b> of collet <b>11</b> may take a variety shapes that have been proposed previously for collets, e.g., flat, grooved or cone-shaped. The collet <b>11</b> has a passage or hole <b>12</b><i>a </i>for holding one end of the rod <b>5</b> and a second hole or passage <b>12</b><i>b </i>for holding one end of the rod <b>1</b>. The rod <b>1</b> may be secured in hole <b>12</b><i>b </i>so that it cannot rotate about within the hole <b>12</b><i>b, </i>to facilitate forming a helix shape. Similarly, the rod <b>5</b> may be tightly held in the hole <b>12</b><i>a </i>so that there is no relative rotation between it and collet <b>11</b> when a torque is applied to collet <b>11</b>.

0038Referring to <figref idref="DRAWINGS">FIGS. 2A-2C</figref>, the collet <b>10</b> is adjustable, both lengthwise and rotationally relative to collet <b>11</b> of the assembly of <figref idref="DRAWINGS">FIG. 1A</figref>. <figref idref="DRAWINGS">FIGS. 2A and 2B</figref> show a cross-sectional front view and side view, respectively of the collet <b>10</b> from <figref idref="DRAWINGS">FIGS. 1A and 1B</figref>. <figref idref="DRAWINGS">FIG. 2A</figref> is taken from the view IIA-IIA as shown in <figref idref="DRAWINGS">FIG. 2B</figref>. <figref idref="DRAWINGS">FIG. 2B</figref> is taken from view IIB-IIB as shown in <figref idref="DRAWINGS">FIG. 1B</figref>. A collar <b>20</b> and sleeve <b>30</b> component parts of the collet <b>10</b> according to one embodiment are shown in the perspective views of <figref idref="DRAWINGS">FIGS. 3-4</figref>.

0039Collet <b>10</b> has holes or passages for receiving ends, respectively, of rods <b>1</b> and <b>5</b>. For collet <b>10</b> these holes or passages extend through the collet <b>10</b> body to provide for length adjustment for rod <b>1</b>, or to position collet <b>10</b> closer or further from collet <b>11</b> to accommodate different length stents. As indicated the ends <b>5</b><i>a </i>and <b>1</b><i>a </i>of rods <b>5</b> and <b>1</b>, respectively, extend through the body of collet <b>10</b> and exit to the right of the collet body as indicated in the figures. The collet <b>10</b> includes collar <b>20</b> which forms a passage or hole <b>24</b> for rod <b>5</b>. The rod <b>5</b> slides within passage <b>24</b> to adjust the distance between collets <b>10</b> and <b>11</b>. The collar <b>20</b> has a circular flange <b>26</b> at the end facing collet <b>11</b> and a pair of deflectable leafs <b>28</b><i>a</i>, <b>28</b><i>b </i>at the opposite end for gripping the collar <b>20</b> when the collet <b>10</b> is rotationally positioned to form the helix, as explained in greater detail below.

0040An outer, generally cylindrical body <b>70</b> can be rotated relative to collar <b>20</b> when the collet <b>10</b> is rotationally positioned to form the helix. Body <b>70</b> may be formed generally as a one-piece structure or two piece structure. The illustrated embodiment shows body <b>70</b> as including an inner sleeve <b>30</b> attached within a circular opening of an outer housing <b>40</b>, which is an example of a two-piece structure for body <b>70</b>. Perspective views of collar <b>20</b> and sleeve <b>30</b> are shown in <figref idref="DRAWINGS">FIGS. 3 and 4</figref>. As can be appreciate from <figref idref="DRAWINGS">FIGS. 2A and 2B</figref>, the housing <b>40</b> and sleeve <b>30</b> of body <b>70</b>, and the collar <b>20</b> each have complimentary openings or passages—sleeve <b>30</b> is secured within an opening in housing <b>40</b>, collar <b>20</b> is received within an opening <b>34</b> in sleeve <b>30</b> and collar <b>20</b> has a passage <b>24</b> for rod <b>5</b>.

0041A geared, or detent-like engagement <b>22</b>/<b>32</b> between the collar <b>20</b> outer surface <b>22</b> and mating inner surface <b>32</b> of sleeve <b>30</b> may be adopted. A gear-like outer surface <b>22</b> having a plurality of teeth <b>21</b> is formed on the collar <b>20</b>, which mates with the surface <b>32</b> of opening <b>34</b> of sleeve <b>30</b>, which has complimentary teeth or detents <b>31</b>, e.g., spaced 90 degrees apart. The sleeve <b>30</b> may include scallops <b>34</b> opposite each tooth <b>31</b> to locally reduce radial stiffness near a tooth <b>31</b> so that the tooth <b>31</b> will deflect outwardly when the body <b>70</b> is rotated relative to the collar <b>20</b> to cause a tooth <b>31</b> to bear against an adjacent tooth <b>21</b> on the collar <b>20</b>. A close-up illustration of the interaction between the sleeve <b>30</b> and collar <b>20</b> from <figref idref="DRAWINGS">FIG. 2B</figref> is illustrated in <figref idref="DRAWINGS">FIG. 2C</figref>. Thus, as body <b>70</b> is rotated clockwise by an incremental angle, e.g., 10, 15, 20, or 30 degrees depending on the number of teeth on collar <b>20</b>, tooth <b>31</b><i>b </i>deflects outwardly as it bears against tooth <b>21</b><i>c. </i>Tooth <b>31</b><i>b </i>then begins to deflect radially outward until it clears the apex of tooth <b>21</b><i>c, </i>then it snaps back into the valley formed by teeth <b>21</b><i>c </i>and <b>21</b><i>a. </i>

0042A passage <b>41</b> for rod <b>1</b> is provided in housing <b>40</b>. Thus, as the body <b>70</b> is rotated as just described, the rod <b>1</b> is rotated about the axis A relative to the collar <b>20</b> and the collet <b>11</b> to shape the helix, where it is understood there is no relative rotation between rod <b>5</b> and neither of collet <b>11</b> and collar <b>20</b>.

0043As mentioned above, the body <b>70</b> need not be formed using the two pieces <b>30</b>, <b>40</b>. Alternatively, the body <b>70</b> may be formed in one piece, where an opening for receiving the collar <b>20</b> within has formed on it teeth <b>31</b> for mating with the teeth <b>21</b> of the gear-like outer surface <b>22</b> of collar <b>20</b>. In the illustrated embodiment two pieces are shown to illustrate an embodiment where the outer member <b>40</b> is made of a relatively stiff material, i.e., metal or hard polymer, while the sleeve <b>30</b> is made of a different material for purposes of providing deflectable detents along its inner surface for engagement with the mating teeth <b>21</b> of the collar <b>20</b>.

0044The collar <b>20</b> may be held in place during body <b>70</b> rotation relative to collar <b>20</b> (to form helix) by a pair of leafs <b>28</b><i>a, </i><b>28</b><i>b </i>extending from one side of the collar <b>20</b> (e.g., using either one's fingers or a clamp to hold leafs <b>28</b><i>a, </i><b>28</b><i>b </i>firmly against the rod <b>5</b> while body <b>70</b> is rotated about collar <b>20</b>). Or, when there is a sufficient frictional fit between the rod <b>5</b> and inner surface of the collar <b>20</b>, no additional rotational restraint of collar <b>20</b> may be necessary to hold collar <b>20</b> in place while body <b>70</b> is rotated about axis A to shape rod <b>1</b> into a helix.

0045The collet <b>10</b> may include a rotational lock that both prevents the body <b>70</b> from rotating relative to the collar <b>20</b> and the collet <b>10</b> from rotating relative to the rod <b>5</b>. Such a rotation lock may be necessary to prevent torsional energy in the helix from causing the body <b>70</b> to back-drive, thereby unwinding the helix (e.g., if the helix is formed by rotating body <b>70</b> clockwise about collar <b>20</b>, then the rod <b>1</b> will apply a reactive counterclockwise torque on the body <b>70</b> causing the helix to unravel; that is, rotate counterclockwise, unless body <b>70</b> is held in rotation relative to collar <b>20</b> and rod <b>5</b>.

0046Referring to <figref idref="DRAWINGS">FIG. 2B</figref>, a rotation lock can be provided in the form of a threaded fastener <b>50</b> having a threaded portion <b>54</b><i>a </i>on its shank. The fastener <b>50</b> is received within a circular thru-hole of the body <b>70</b> which provides passage of the tip of the fastener <b>50</b> into the opening <b>24</b> of the collar <b>20</b> so that the tip of the fastener <b>50</b> can be screwed firmly against the rod <b>5</b>. The thru-hole <b>44</b> includes a mating threading <b>44</b><i>a </i>to engage the threads <b>54</b><i>a </i>of the fastener <b>50</b>. When the tip of the fastener <b>50</b> is pressed against the rod <b>5</b> in the passage <b>24</b>, the collet <b>10</b> may be prevented from rotating about the axis A (i.e., the axis collinear with rod <b>5</b> longitudinal axis, see <figref idref="DRAWINGS">FIG. 1C</figref>) relative to the rod <b>5</b>, and the body <b>70</b> also will not rotate relative to the collar <b>20</b>.

0047In alternative embodiments no fastener <b>50</b> is used. Instead, a tight fit between the rod <b>5</b> and collar <b>20</b> can hold the collet <b>10</b> in place by friction. In another embodiment, the rod <b>5</b> may have a threading and the inner surface of collar <b>20</b> forms a mating threading. In this embodiment the collet <b>10</b> is rotated about the rod <b>5</b> to adjust its position relative to the collet <b>11</b>. Once the desired position for collet <b>10</b> is found, the rod <b>1</b> is passed through the hole <b>41</b> provided in member <b>40</b> and the body <b>70</b> rotated while the collar <b>20</b> is held in place. The threaded engagement between rod <b>5</b> and collar <b>20</b> can be made sufficiently tight to hold the collar <b>20</b> in rotation while the body <b>70</b> is rotated to form the rod <b>1</b> into a helix. Once the helix <b>1</b> is formed, the rotational position of the body <b>70</b> relative to the collar <b>20</b> may be maintained by the interlocking teeth <b>21</b>/<b>31</b> between the sleeve <b>30</b> and collar <b>20</b>. A close-up of the interlocking teeth is shown in <figref idref="DRAWINGS">FIG. 2C</figref>.

0048When configuring the assembly of <figref idref="DRAWINGS">FIG. 1A</figref> for a particular diameter and length tubular medical device, the following steps may be used. First, the rods <b>1</b> and <b>5</b> are attached to collet <b>11</b>. Next, the stent is placed over the rods <b>1</b>, <b>5</b>. The other ends of the rods are then passed through their respective through-holes <b>41</b> and <b>24</b> in collet <b>10</b>. The amount of rod <b>1</b> between collets <b>10</b> and <b>11</b> may depend on the type of helix formed, length and diameter of the medical device. The rod <b>5</b> position is dependent on the amount of space desired between the medical device, if any, and the faces of the collets. Once this position is determined, the collar <b>20</b> is then fixed in rotation relative to the rod <b>5</b>, e.g., by gripping leafs <b>28</b><i>a</i>, <b>28</b><i>b </i>manually, or using a clamp, to prevent collar <b>20</b> from rotating relative to the rod <b>5</b>. Alternatively, there may be sufficient frictional contact between the wall of passage <b>24</b> and outer surface of rod <b>5</b> so that leafs <b>28</b><i>a</i>, <b>28</b><i>b </i>are not necessary. The body <b>70</b> is then rotated or clocked about the collar <b>20</b> to form the desired helix shape. During the process of forming the helix <b>1</b> the amount of rod <b>1</b> between the collets may need adjustment to achieve the desired diameter and/or revolutions in the helix extending between the collets. This may be done by gripping end <b>1</b><i>a </i>of rod <b>1</b> (to the right of collet <b>10</b> in <figref idref="DRAWINGS">FIG. 1A</figref>) pushing it to the left or pulling to the right, explained in greater detail, below, in connection with <figref idref="DRAWINGS">FIGS. 5-8</figref>. Once the helix <b>1</b> is formed, the engaging teeth <b>21</b>/<b>31</b> between the collar <b>20</b> and sleeve <b>30</b> can hold the helix shape, i.e., prevent the body <b>70</b> from rotating relative to the collar, thereby undoing the helix. Or a rotation lock, e.g., fastener <b>50</b>, may be used to fix the collar <b>20</b>, rod <b>5</b> and body <b>70</b> in rotation. This method is illustrated in <figref idref="DRAWINGS">FIG. 9</figref>.

0049Referring again to <figref idref="DRAWINGS">FIG. 1A</figref>, in another embodiment the assembly may include the first collet <b>11</b> and an alternative to the second collet where there is no sleeve <b>30</b> or collar <b>20</b> used (housing <b>40</b>′). Rather, the collet includes the housing having a central passage for the rod <b>5</b> and hole <b>41</b> for rod <b>1</b>. In this embodiment the rod <b>1</b> may be shaped to circumscribe the rod <b>5</b> (to provide the supporting surface for the stent) by rotating the second collet housing <b>40</b>′ about the rod <b>5</b> which is fixed to the collet <b>10</b>. Once the desired rod <b>1</b> shape is made, the fastener <b>50</b> may be pressed into the rod <b>1</b> (as before) to hold the collet <b>40</b>′ in place relative to the collet <b>10</b>, thereby maintain the shape of the rod <b>1</b>. This method is also illustrated in <figref idref="DRAWINGS">FIG. 9</figref>.

0050Alternatively, the fastener <b>50</b> may be located on the collet <b>10</b> to fix the rod <b>5</b> to the collet <b>11</b> after the rod <b>1</b> is shaped by rotation of collet <b>10</b> and rod <b>1</b> (rod <b>1</b> is fixed to collet <b>10</b>). In this embodiment, therefore, the assembly would proceed as follows. First, the stent is placed on the rod <b>5</b>, which is attached to collet <b>10</b>. The rod <b>5</b> end is then inserted into the collet <b>11</b>. The rod <b>1</b> is also attached to the collet <b>10</b> and <b>11</b>. After the collet <b>10</b> and rod <b>5</b> are rotated relative to the collet <b>11</b> to form the desired shape of rod <b>1</b>, the fastener is used to fix the collet <b>11</b> in rotation about axis A to the rod <b>5</b>.

0051As will be understood, rod <b>1</b> needs to have inherent flexural rigidity, i.e., bending stiffness, as well as relatively large elastic range to enable to be shaped into various helical forms when a torque is applied, i.e., when body <b>70</b> is rotated relative to collet <b>11</b> in <figref idref="DRAWINGS">FIG. 1A</figref>. It has been found that a super-elastic material, such as Nitinol, can perform this function adequately.

0052<figref idref="DRAWINGS">FIGS. 5-8</figref> show a range of helical shapes for supporting differently-sized tubular medical devices according to the disclosure. The same length rod <b>1</b> is used in each of <figref idref="DRAWINGS">FIGS. 5-8</figref>. As shown, different amounts of rod <b>1</b> are to the right of collet <b>10</b> (note different lengths for end <b>1</b><i>a </i>among the illustrations) to create larger/smaller diameters and/or more/less revolutions of the helix, depending on the type of tubular medical device. Some medical devices require more support, thus more revolutions are formed, while others require less, thus less revolutions are formed.

0053To accommodate a larger diameter stent, for example, or where more revolutions of the helix are desired to provide greater support for a stent, more rod <b>1</b> material is disposed between the collets before body <b>70</b> is rotated about collar <b>20</b>. When fewer revolutions or turns, or a smaller diameter of the helix is desired then less of the rod <b>1</b> material is between the collets before body <b>70</b> is rotated about collar <b>20</b>. The amount of rod <b>1</b> material between the collets may be adjusted as the body <b>70</b> is rotated to make adjustments. The distance between the collets may also be adjusted while the helix is being formed to arrive at the desired shape. This can be done by gripping the leafs <b>28</b><i>a</i>, <b>28</b><i>b </i>to push the collet <b>10</b> closer or farther from the collet <b>11</b> with one hand, while the body <b>70</b> is rotated relative to the collar <b>20</b> with the other hand.

0054When a geared interaction <b>22</b>/<b>32</b> between collar <b>20</b> and body <b>70</b> is provided, the rotational amounts applied may be easily controlled to arrive at the desired size and/or number of revolutions. Alternatively, it may be predetermined how much of rod <b>1</b> needs to be between the collets to arrive at the desired shape. That is, one can calculate the length of the rod <b>1</b> between the collets needed to arrive at the desired number of revolutions or diameter of the helix. Similarly, the amount of rotations of body <b>70</b> may be predetermined or calculated.

0055<figref idref="DRAWINGS">FIG. 5</figref> shows a first support for a medical device. The supporting helix has a diameter D<b>1</b> and the collets <b>10</b>, <b>11</b> are spaced apart by a length L<b>1</b>. If more of rod <b>1</b> is pulled through opening <b>41</b> in housing and collet <b>10</b> moved closer to collet <b>11</b>, then the same number of revolutions and diameter of the helix may be formed for a shorter stent (L<b>2</b>&lt;L<b>1</b>), as illustrated in <figref idref="DRAWINGS">FIG. 6</figref>.

0056In <figref idref="DRAWINGS">FIG. 7</figref> the assembly is made for a shorter stent but with an increased number of revolutions or turns in the helix. Thus, more of rod <b>1</b> may be needed between the collets to create more revolutions, even though L<b>3</b> is less than L<b>2</b>.

0057<figref idref="DRAWINGS">FIG. 8</figref> shows an assembly for a stent that has both a larger diameter and more revolutions than the assembly of <figref idref="DRAWINGS">FIG. 6</figref>. IN this case, more rod <b>1</b> material is needed between the collets than in the case of <figref idref="DRAWINGS">FIG. 6</figref>.

0058The above description of illustrated embodiments of the invention, including what is described in the Abstract, is not intended to be exhaustive or to limit the invention to the precise forms disclosed. While specific embodiments of, and examples for, the invention are described herein for illustrative purposes, various modifications are possible within the scope of the invention, as those skilled in the relevant art will recognize.

0059These modifications can be made to the invention in light of the above detailed description. The terms used in claims should not be construed to limit the invention to the specific embodiments disclosed in the specification. Rather, the scope of the invention is to be determined entirely by claims, which are to be construed in accordance with established doctrines of claim interpretation.