METHODS AND SYSTEMS FOR SECURING A SLEEVE FOR ENDOLUMINAL DEVICES

The present disclosure describes methods and apparatus for preparing a sleeve used to surround and assist in delivering an expandable implant to the vasculature of a human patient. The sleeve is formed by curving a sheet of material, longitudinally folding the material, and securing the longitudinally folded material with an elongated member, such as wire or thread, to form a sleeve. The resulting sleeve can then receive an endoluminal device.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

In various embodiments, a sleeve for covering or protecting an endoluminal device, compressing an endoluminal device, and/or maintaining an endoluminal device in a compressed state (any of the foregoing referred to herein as a “constraining sleeve” or a “sleeve”) is formed by curving a sheet of material such that one edge is proximate another edge, such that the general shape of a constraining sleeve is formed. As described in connection with the various embodiments disclosed herein, the curved material is then flattened, after which it is longitudinally folded to create a plurality of longitudinal folds. A plurality of holes is created in the longitudinal folds. The holes are then used to receive an elongated member, such as a thread or wire to secure the curved material in the configuration of a constraining sleeve.

As described in more detail below, various embodiments of a device used to create a constraining sleeve comprise an introducing section, a folding section, and a threading section. In accordance with various embodiments of the disclosure, the introducing section comprises one or more mechanisms which receive, orient and at least partially flatten the curved sheet of material. The folding section comprises one or more mechanisms which longitudinally fold the curved, flattened sheet of material creating a plurality of longitudinal folds without introducing significant stresses and strains in the material as it is folded. In accordance with various embodiments of the disclosure, the threading section comprises one or more mechanisms which create a plurality of holes in the longitudinal folds and which may facilitate the threading of the holes with an elongated member. In the context of this disclosure, “elongated member” can mean any member, such as, for example, a metal, organic, synthetic, and/or polymeric thread or wire, which can suitably secure a material and can be biocompatible.

With reference toFIG. 1, an embodiment of a constraining sleeves100in accordance with the present disclosure are illustrated. Constraining sleeve100comprises a sheet of material110, curved to create a lumen120in the general shape of constraining sleeve100by locating edges102of material110proximate one another. A plurality of holes130aligned in the edges102proximate one another allow an elongated member140to be passed therethrough to secure constraining sleeve100in its desired configuration. Elongated member140may be secured by one or more knots150. Constraining sleeve100thus formed may be used to cover, protect, compress and/or maintain compressed an endoluminal device104, and upon delivery to a treatment site, elongated member140may be removed, allowing the removal of constraining sleeve100from endoluminal device104.

With reference toFIG. 2A, material110in accordance with the present disclosure comprises a top surface206, a bottom surface208, a first longitudinal edge202, and a second longitudinal edge204. Material110can comprise a biocompatible material, such as, for example, expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, fluoropolymers, such as perfouorelastomers and the like, polytetrafluoroethylene, silicones, urethanes, ultra high molecular weight polyethylene, aramid fibers, and combinations thereof. In various embodiments, material110can include high strength polymer fibers such as ultra high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.).

Material110can include a bioactive agent. For example, material110can be coated by a therapeutic agent such as, for example, heparin, sirolimus, paclitaxel, everolimus, ABT-578, mycophenolic acid, tacrolimus, estradiol, oxygen free radical scavenger, biolimus A9, anti-CD34 antibodies, PDGF receptor blockers, MMP-1 receptor blockers, VEGF, G-CSF, HMG-CoA reductase inhibitors, stimulators of iNOS and eNOS, ACE inhibitors, ARBs, doxycycline, thalidomide, and many others. The use of any therapeutic coating which can be applied to material110is within the scope of the present disclosure.

With reference toFIGS. 2B,2C,3A,3B,3C, and3D material110can be curved to form the general shape of constraining sleeve100. Sleeve100can be formed, for example, by curving material110such that first longitudinal edge202and second longitudinal edge204are aligned substantially parallel to each other and top surface206is adjacent to and/or in contact with itself and creating a curved portion212, as illustrated inFIG. 3B. Alternatively, as illustrated inFIG. 3C, sleeve100can be formed by curving material110such that first longitudinal edge202and second longitudinal edge204are aligned substantially parallel to each other, and top surface206overlaps bottom surface208, or vice versa.

In other embodiments, as illustrated inFIG. 3D, sleeve100can be formed by curving material110such that first longitudinal edge202and second longitudinal edge203are aligned substantially parallel to each other, and bottom surface208is adjacent to and/or in contact with itself. However, any manner of curving material110such that it creates a sleeve100is within the scope of the present disclosure. Material110can then be processed using various embodiment of devices such as those disclosed herein to form a constraining sleeve for covering, protecting, compressing, and/or maintaining an endoluminal device in a compressed state.

As described in additional detail below, constraining sleeves such as those described above can be formed by a sleeve securing device. For example, the sleeve securing device can comprise an introducing section, a folding section, and a threading section. In such embodiments, curved material such as noted above is initially placed in the introducing section, advanced through the folding section to create a plurality of folds (designated as reference numeral111inFIG. 1), and advanced through the threading section to create the above-noted holes and optionally, to thread and secure curved material as a constraining sleeve.

The introducing section of the sleeve securing device can be configured to receive, orient and at least partially flatten the curved sheet of material. In such configurations, opposing edges of the curved material are placed within a guide, such as, for example, a channel, pathway, or a slot, which helps maintain the material in the above-noted noted curved configuration. The material is then advanced to the folding section of the device.

The folding section of the sleeve securing device can be configured to create a plurality of alternating longitudinal folds (e.g., accordion folds111) in the material by, for example, advancing the curved, flattened sheet of material through a pair of opposing rollers having a plurality of roller teeth. In such embodiments, each fold is comprised of two or more layers of the material by virtue of the material being curved such that one longitudinal edge is proximate another longitudinal edge. The roller teeth may create the plurality of longitudinal folds at an angle to a longitudinal axis (e.g., axis220ofFIG. 2B) of the material such as perpendicular or at other angles. The curved, flattened material may thus be folded without unduly stretching, stressing, or straining the material, and can reduce or prevent failure of the material.

In various exemplary embodiments, folds111are temporary folds which do not permanently fold or crease material110. For example, inFIG. 1, folds111are temporary folds created by two opposing rollers. Folds111are illustrated in phantom lines to indicate their position relative to lumen120, holes130, and elongated member140. After sleeve100is formed, folds111may not be visible, or may be visible only as slight creases in material110.

As the longitudinal folds are formed in the material, they are advanced to the threading section. The threading section may be configured as within, partially within, or exterior to the folding section. The threading section can use a threading element, such as a hollow needle, to puncture the material at each fold, creating a plurality of corresponding holes proximate the edges of the material. After the material has been punctured to create the plurality of holes, an elongated member can be passed through the holes. A constraining sleeve is thus formed by securing the elongated member by, for example, tying it in one or more knots.

With reference now toFIG. 4A, an embodiment of a sleeve securing device400in accordance with the present disclosure comprises an introducing section430, a folding section420, and a threading section440. In various embodiments, any of introducing section430, folding section420, and threading section440are removably coupled to base460or any suitable support or stanchion by, for example, threaded fasteners, clamps, bolts, screws, pins, press-fitting, magnetism, or any other suitable method of removably coupling. In other embodiments, various sections can be permanently coupled to base460or any suitable support or stanchion by, for example, welding or casting, or any other suitable method of permanently coupling.

As described above, in various embodiments, introducing section430is configured to receive a material110which has been curved such that one edge202is proximate another edge204as described above. In such configurations, introducing section430receives material110and orients and at least partially flattens it so that it may be advanced to folding section420.

In this regard, as illustrated inFIGS. 4A and 4B, introducing section430can include a material guide438. Material guide438can be configured to maintain material110in the curved configuration. In some embodiments, material guide438includes an entry slot432. In various embodiments, entry slot432is configured in a “C-channel” shape, such that material110can be inserted into entry slot432lengthwise. In various embodiments, material110is inserted into entry slot432in a curved configuration such that first longitudinal edge202and second longitudinal edge204are generally parallel and maintained in proximity to each other. In this manner, the edges202and204of material110are inserted into entry slot432, and curved portion212of material110is in proximity to the open portion of the channel of entry slot432.

Once positioned in entry slot432, material110can be advanced through material guide438to an exit slot434. Similarly to entry slot432, exit slot434can comprise a C-channel shape, such that material110traverses exit slot434lengthwise. Exit slot434can be configured to properly orient and/or flatten material110as it is advanced to folding section420.

As noted previously, introducing section430can be coupled to base460in various manners. In an embodiment, material guide438can be removably or permanently coupled to a folding section support436. Folding section support436can in turn be removably coupled to base460or any suitable support or stanchion by, for example, threaded fasteners, clamps, bolts, screws, pins, press-fitting, magnetism, or any other suitable method of removably coupling. Alternatively, folding section support436can be permanently coupled to base460or any suitable support or stanchion by, for example, welding or casting, or any other suitable method of permanently coupling.

In various embodiments, folding section420is located proximate introducing section430and is configured to receive material110from introducing section430. As described above, folding section420can be configured to create a longitudinally folded material with a plurality of alternating longitudinal folds at an angle to the longitudinal axis220of material110. As noted above, the angle may be generally perpendicular, though in some embodiments, other angles may be desirable.

For example, as material110is advanced through folding section420, a longitudinally folded material is formed. With reference toFIGS. 5A and 5B, in various embodiments, a longitudinally folded material500comprises a plurality of alternating longitudinal folds504, such that material110is folded in alternating directions in an accordion fashion. In such embodiments, each fold is comprised of two layers of material110by virtue of the material being curved such that one longitudinal edge is proximate another longitudinal edge.

With reference now toFIGS. 4B and 4C, folding section420can comprise a pair of opposing rollers, such as a first roller422and a second roller424. In such configurations, first roller422and second roller424form a longitudinally folded material500by creating a plurality of alternating longitudinal folds504as material110travels through the rollers422,424. However, any method or system of forming a longitudinally folded material500is within the scope of the present disclosure.

First roller422and second roller424can comprise, for example, cylindrically-shaped rollers. In other embodiments, rollers422and424comprise substantially cone shaped rollers. Any shape and size of first roller422and second roller424that can form alternating longitudinal folds504in material110is within the scope of the present disclosure.

In various embodiments, first roller422and second roller424are positioned generally along parallel rotational axes. First roller422can be rotated along a first rotational axis428. Second roller424can be rotated along a second rotational axis429, for example, in the opposite direction of first roller422. In some embodiments, as first roller422and second roller424are rotated, material110is pulled through folding section420.

Referring back toFIG. 4A, in various embodiments, one of first roller422and second roller424can be rotated by a crank427, and the roller that is cranked in turn is operable to rotate the other roller. Crank427can be a manual crank which is operated by a user physically rotating the crank. Crank427can be an automatic crank powered by, for example, an electric motor, including one with a constant or variable speed. Any manner of rotating crank427, and thereby rotating first roller422and second roller424, is within the scope of the present disclosure.

With reference again toFIGS. 4B and 4C, in various embodiments, first roller422and second roller424each comprise a plurality of roller teeth426. In such configurations, as material110is advanced through folding section420, roller teeth426of first roller422and second roller424create the alternating longitudinal folds504of longitudinally folded material500.

The spacing of roller teeth426on first roller422and second roller424can vary. For example, roller teeth426can be evenly spaced apart, creating symmetrical and evenly spaced longitudinal folds504in material110. In other embodiments, roller teeth426can be unevenly spaced apart, such that longitudinal folds504vary in size and spacing. In general, any spacing of roller teeth426which creates suitable longitudinal folds504is within the scope of the present disclosure.

The size and shape of roller teeth426can also vary. For example, all of roller teeth426can comprise the same size and shape. This configuration would create symmetrical longitudinal folds504in material110. In other embodiments, the size and/or shape of roller teeth426can vary, creating longitudinal folds504that vary in size and shape. In general, any size and shape of roller teeth426which creates suitable longitudinal folds504is within the scope of the present disclosure.

In various embodiments first roller422comprises a first notch423. First notch423can be configured to allow a threading element, such as a needle or shaft, to pass through first notch423as first roller422rotates. In various embodiments, second roller424can comprise a second notch425. Similarly to first notch423, second notch425can be configured to allow a threading element to pass through it as second roller424rotates.

As noted previously, folding section420can be coupled to base460. In various embodiments, and with reference back toFIG. 4A, a first roller support410and a second roller support412can be removably or permanently coupled to first roller422and second roller424, respectively. First roller support410and second roller support412can in turn be removably coupled to base460or any suitable support or stanchion by, for example, threaded fasteners, clamps, bolts, screws, pins, press-fitting, magnetism, or any other suitable method of removably coupling. Alternatively, first roller support410and second roller support412can be permanently coupled to base460or any suitable support or stanchion by, for example, welding or casting, or any other suitable method of permanently coupling.

In various embodiments, as it passes through or after it passes through first roller422and second roller424, longitudinally folded material500is advanced to threading section440. Threading section440is configured to create the plurality of holes described above in longitudinally folded material500, generally proximate edges202,204, and may further facilitate the threading of the holes with a thread to form a constraining sleeve.

In this regard, and with reference to bothFIGS. 4A,4B, and4C, in various embodiments, threading section440can include a threading element442. In such configurations, threading element442can comprise a hollow shaft, such as a hypodermic needle. Any threading element which allows an elongated member to pass through it is within the scope of the present disclosure.

In various embodiments, and as better seen inFIGS. 4B and 4Cthreading element442can be configured to pass through first notch423of first roller422and second notch425of second roller424. In such embodiments, first notch423and second notch425are aligned such that threading element442can pass through both notches while first roller422and second roller424are rotating.

Turning back toFIG. 4A, in various embodiments, threading element442can be coupled to a sled444. In such configurations, sled444can be used to properly position threading element442relative to folding section420by moving towards and away from folding section420. Sled444can be positioned on a track446, which allows sled444to move longitudinally without moving in other directions.

In various embodiments, track446can be coupled to base460. Track446can in turn be removably coupled to base460or any suitable support or stanchion by, for example, threaded fasteners, clamps, bolts, screws, pins, press-fitting, magnetism, or any other suitable method of removably coupling. Alternatively, track446can be permanently coupled to base460or any suitable support or stanchion by, for example, welding or casting, or any other suitable method of permanently coupling.

Threading section440can include a first stop452. First stop452is positioned on base460to properly position threading element442with relation to folding section420and prevent threading element442from extending too far into folding section420. Threading section440can further include a second stop454. Second stop454is positioned on base460to prevent sled444from traveling too far away from folding section420and potentially disengaging from track446.

In various embodiments, threading section440includes a locking mechanism450. In such embodiments, when threading element442is properly positioned in relation to folding section420, locking mechanism450can be engaged to maintain the position of threading element442by, for example, temporarily fixing the position of sled444to which threading element442is attached. Any configuration of locking mechanism450which secures the position of threading element442is within the scope of the present disclosure.

With reference toFIG. 5B, as material110is folded to create longitudinally folded material500, threading element442can create a plurality of holes502in longitudinally folded material500. In various embodiments, holes502are aligned along the length of longitudinally folded material500, generally proximate edges202,204. Holes502may be positioned such that each is generally centered between each fold504on either side of each hole502. In other configurations, each hole502may be at other positions relative to each fold504.

In various exemplary embodiments, threading element442can engage longitudinally folded material500as it passes through first roller422and second roller424, creating plurality of holes502. As illustrated inFIG. 4B, in such configurations, threading element442is positioned within first notch423and second notch425, and as longitudinally folded material500progresses through folding section420, longitudinally folded material500can gather on threading element442.

In various embodiments, an elongated member can be used to secure longitudinally folded material500. In such embodiments, an elongated member is passed through threading element442. As threading element442is in communication with holes502, the elongated member passes through holes502and emerges from threading element442on the far side of longitudinally folded material500. The elongated member can comprise, for example, ePTFE, polyester, polyurethane, fluoropolymers, such as perfouorelastomers and the like, polytetrafluoroethylene, silicones, urethanes, ultra high molecular weight polyethylene, aramid fibers, or combinations thereof. Any elongated member, such as a metal, synthetic, organic, and/or polymeric thread or wire, which can suitably secure longitudinally folded material500and is biocompatible, is within the scope of the present disclosure.

After the elongated member has passed through all of holes502of longitudinally folded material500, locking mechanism450can be disengaged and sled444can be returned to its initial position. Longitudinally folded material500can then be removed from threading element442, leaving the elongated member threaded through holes502.

After passing through the plurality of holes502, the elongated member can be secured, creating a constraining sleeve such as illustrated inFIG. 1. In various embodiments, the elongated member is secured by, for example, tying a knot. However, any manner of suitably securing the elongated member is within the scope of the present disclosure.

After removal from sleeve securing device400, an endoluminal device can be inserted into the lumen constraining sleeve. For example, with momentary reference toFIG. 1, an endoluminal device104can be inserted into lumen120of constraining sleeve100.

Likewise, numerous characteristics and advantages have been set forth in the preceding description, including various alternatives together with details of the structure and function of the devices and/or methods. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications can be made, especially in matters of structure, materials, elements, components, shape, size and arrangement of parts including combinations within the principles of the disclosure, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein.