Abstract
Inverting tube apparatuses and methods of using same for removing large amounts of material from a body lumen. The apparatuses and methods described herein may use a depot for holding, in a compressed configuration, a length of the flexible tube configured to invert over the distal end of an inversion support catheter to capture material within a body lumen. The depot is configured to facilitate the release of the flexible tube with a low release force, and in a manner that prevents snagging or binding of the flexible tube either on the body of the catheter or when rolling and inverting into the inversion support catheter.
Claims
1. An apparatus for removing a material from a body lumen, the apparatus comprising: an elongate inversion support catheter having a proximal end region, a distal end region, and a distal end opening; an elongate puller extending within the inversion support catheter; a flexible tube having a distal first end attached to the puller, wherein the flexible tube extends over an outer surface of the inversion support catheter and is configured to invert into the distal end opening of the inversion support catheter when the puller is pulled proximally; and a depot movably coupled to the proximal end region of the inversion support catheter, the depot comprising an inner storage region, wherein a proximal portion of the flexible tube is held compressed within the inner storage region in a folded configuration that is configured to unfurl out of a distal end opening of the depot when the puller is pulled proximally.
2. The apparatus of claim 1, further comprising a distal guide forming the distal end opening of the depot, wherein the distal guide is configured to guide the flexible tube out of the depot as the flexible tube is unfurled.
3. The apparatus of claim 2, further comprising an introducer sheath, wherein the distal guide is configured to engage with the introducer sheath to secure the depot to the introducer sheath.
4. The apparatus of claim 3, wherein the depot is configured to engage over a proximal sheath hub of the introducer sheath.
5. The apparatus of claim 3, wherein the depot is configured to engage within a proximal sheath hub of the introducer sheath.
6. The apparatus of claim 1, wherein the depot comprises a transparent outer region allowing visualization of the flexible tube within the inner storage region.
7. The apparatus of claim 1, wherein in the folded configuration, the flexible tube comprises a zig-zag pattern that is disposed in parallel to a long axis of the inversion support catheter.
8. The apparatus of claim 1, wherein in the folded configuration, the flexible tube comprises a zig-zag pattern of the flexible tube is disposed transverse to a long axis of the inversion support catheter.
9. The apparatus of claim 1, wherein greater than 50% of a length of the flexible tube is held within the depot in an undeployed configuration.
10. The apparatus of claim 1, wherein the flexible tube is held compressed within the inner storage region with greater than a 10-fold compression along the length of the flexible tube.
11. The apparatus of claim 1, further comprising a valve on the depot configured to receive a flushing solution and/or a pressurizing solution.
12. The apparatus of claim 1, wherein the depot is slidable along the inversion support catheter.
13. An apparatus for removing a material from a body lumen, the apparatus comprising: an elongate inversion support catheter having a proximal end region, a distal end region, and a distal end opening; an elongate puller extending within the inversion support catheter; a flexible tube having a distal first end attached to the puller, wherein the flexible tube extends over an outer surface of the inversion support catheter and is configured to invert into the distal end opening of the inversion support catheter when the puller is pulled proximally; a depot slidably coupled to the proximal end region of the inversion support catheter, the depot comprising an inner storage region, wherein a proximal portion of the flexible tube is held compressed within the inner storage region in a fanfold configuration, and is configured to unfurl out of a distal end opening of the depot when the puller is pulled proximally; and a distal guide forming the distal end opening of the depot, wherein the distal guide is configured to engage with an introducer sheath, and to guide the flexible tube out of the depot as the flexible tube is unfurled.
14. A method of removing a clot from a blood vessel, the method comprising: advancing an inverting tube apparatus through the blood vessel until a distal end portion of the inverting tube apparatus is located proximate to the clot, wherein the inverting tube apparatus comprises an inversion support catheter having an elongate and flexible catheter body, a puller within a lumen of the inversion support catheter, and a flexible tube coupled at a distal end to the puller, the flexible tube extending over an exterior surface of the inversion support catheter, wherein the flexible tube is held compressed within an inner storage region of a depot on a proximal end region of the inversion support catheter; pulling the puller proximally to thereby roll the flexible tube over a distal end opening of the inversion support catheter so that the flexible tube captures the clot and pulls the clot proximally into the lumen of the inversion support catheter; wherein pulling the puller proximally draws the flexible tube from out of the depot so that the flexible tube unfurls distally from a compressed fanfold configuration within the depot.
15. The method of claim 21, wherein pulling the puller proximally to draw the flexible tube from out of the depot comprises guiding the flexible tube out of the inner storage region using a distal guide on the depot.
16. The method of claim 21, further comprising inserting the inverting tube apparatus into an introducer sheath and into the blood vessel.
17. The method of claim 23, further comprising locking the depot to a proximal end of the introducer sheath.
18. The method of claim 21, further comprising pressurizing the inner storage region of the depot.
19. The method of claim 21, further comprising flushing a flushing fluid through the depot.
20. The method of claim 21, further comprising injecting a contrast agent through the depot.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] A better understanding of the features and advantages of the disclosed apparatuses and methods of using same will be obtained by reference to the following detailed description when read in conjunction with reviewing the accompanying drawings, in which:
[0027] FIGS. 1A-1C illustrate an example of a mechanical inverting tube apparatus that may be used to remove material from a vessel. In FIG. 1A, the assembled apparatus is shown in a side view, showing an inversion support catheter and a flexible outer tube. FIG. 1B shows the inverting tube apparatus of FIG. 1A in a vessel, proximal to a clot. FIG. 1C illustrates the removal of a clot from the vessel using the apparatus of FIG. 1A, by pulling the flexible tube on the outside of the inversion support catheter proximally so that it rolls over the distal end of the inversion support catheter and into the inversion support catheter, drawing the clot with it; the apparatus may be advanced distally.
[0028] FIG. 2A is an example of a mechanical inverting tube apparatus similar to that shown in FIG. 1A-1C, having a flexible tube that has a maximum length that is limited to the length of the puller or the length of the inversion support catheter. FIG. 2B illustrates insertion of the apparatus of claim 2A into a body lumen, though the skin. FIG. 2C illustrate operation of the apparatus of claim 2A to remove material from the body lumen.
[0029] FIGS. 3A-3C illustrate one example of a mechanical inverting tube apparatus having a proximal depot configured to hold the flexible tube in a quick-release configuration.
[0030] FIG. 3A show the mechanical inverting tube apparatus including a proximal depot coupled to the inversion support catheter and housing the flexible tube. FIG. 3B shows the apparatus of FIG. 3A inserted through a sheath into a body lumen. FIG. 3C illustrates operation of the apparatus of FIG. 3A with the flexible tube being pulled proximally and inverting into the inversion support catheter to remove material from the vessel.
[0031] FIGS. 4A-4B illustrates another example of a mechanical inverting tube apparatus having a proximal depot configured to hold the flexible tube in a quick-release configuration. FIG. 4A shows the apparatus, including a distal funnel region. FIG. 4B illustrates the apparatus of FIG. 4A deployed into a body lumen (e.g., blood vessel).
[0032] FIGS. 5A-5B illustrate an apparatus similar to that shown m FIGS. 4A-4B m operation.
[0033] FIGS. 6A-6B illustrate one example of a flexible tube (configured as a woven flexible tube) shape-set into a compressed, quick-release configuration.
[0034] FIG. 7A illustrate another example of a mechanical inverting tube apparatus having a depot, including an inner liner and a valve for flushing and/or pressurizing the depot.
[0035] FIG. 7B is an example of a mechanical inverting tube apparatus having a depot configured to attach over in sheath.
[0036] FIGS. 8A-8B illustrate another example of a mechanical inverting tube apparatus having a depot, in which the depot includes a distal sleeve portion.
[0037] FIG. 9 shows another example of a mechanical inverting tube apparatus having a depot including guides for guiding the flexible tube.
DETAILED DESCRIPTION
[0038] In general, described herein are mechanical inverting tube apparatuses (e.g., systems and devices, including thrombectomy systems and thrombectomy devices) and methods of using them for removing material, such as thrombus (e.g., clot) material from a body lumen, such as a blood vessel. In particular, described herein are mechanical inverting tube apparatuses that include a depot configured to hold the flexible tube in a quick-release configuration. These apparatuses may be used to remove a larger amount of material, such as clot material, from a body lumen using an inverting flexible tube that may be many times longer than the length of the apparatus (e.g., the inversion support catheter) without jamming. The methods and apparatuses described herein represent a substantial improvement over previously described apparatuses that were either limited to a relatively small maximum length of flexible tube that could be used to invert and withdraw material, or were prone to jamming and failure within the body.
[0039] In general, a mechanical inverting tube apparatus (also referred to as “mechanical thrombectomy apparatus” in some variations) may be configured to remove clot using a length of inverting tube, as shown in FIGS. 1A-IC. The apparatuses and methods of using them described herein may effective for use with the vasculature, including the neurovasculature and the peripheral vasculature, including for use with relatively larger and/or longer clots (e.g., relative to the length of the flexible tube).
[0040] For example, FIG. 1A illustrates an example of an inverting tractor mechanical thrombectomy apparatus 100, such as described in U.S. patent application Ser. No. 15/496,570, and in U.S. Pat. No. 9,463,035. The apparatus includes an inversion support catheter 107 and a flexible tube 103 that extends over the outer surface of the inversion catheter. The flexible tube may be referred to as a tractor tube (or flexible tractor tube), and may be attached at one end region to a puller 101, which may be pull wire or pull tube (e.g., catheter), e.g., at the distal end region of the puller. In some variations the flexible tube may be attached proximal to the distal end of the puller (e.g. between 1 mm and 50 mm from the distal end, between 1 mm and 40 mm, between I mm and 30 mm, greater than 5 mm, greater than 10 mm, greater than 20 mm, greater than 30 mm, etc. from the distal end of the puller). Pulling the puller proximally inverts the flexible tube over the distal end opening 111 of the inversion support catheter to capture and remove a material (such as a clot) in the vessel lumen, as shown in FIGS. 1B and 1C. In operation, the amount of the material that may be captured corresponds to the length of the flexible tube.
[0041] In FIG. 1B the inverting tractor mechanical thrombectomy apparatus 100 is shown deployed near a clot 109. In the deployed configuration the puller 101 (shown here as a puller micro catheter, alternatively the puller may be a wire) is held within an elongate inversion support catheter 107 so that the flexile tractor tube 103 extends from the end of the puller 101 and expands toward the inner radius of the elongate inversion support catheter I 07; at the distal end opening 111 of the elongate inversion support catheter the tractor tube inverts over itself and extends proximally in an inverted configuration over the distal end of the elongate inversion support catheter. As shown in FIG. 1C, by pulling the puller proximally, the tractor tube rolls 113, 113′ and everts over the distal end opening of the elongate inversion support catheter, drawing the adjacent clot into the elongate inversion support catheter, as shown.
[0042] FIG. 1A the elongate inversion support catheter is an elongate tube having a distal end that has the same size inner diameter as the proximal length of the inversion support catheter. In some variations the distal end of the inversion support catheter may be funnel-shaped (or configured to expand into a funnel shape, see, e.g. FIGS. 4A-4B). In FIGS. 1A-1C, the inversion support catheter 107 is shown positioned between the tractor tube (e.g., flexible tube 103) and the puller 101 so that the flexible tube can be pulled proximally by pulling on the puller and rolling the flexible tube into the elongate inversion support catheter so that it inverts. The portion of the flexible tube that is inverted over the distal end of the elongate inversion support catheter has an outer diameter that is greater than the outer diameter of the elongate inversion support catheter. The flexible tube may be biased so that it has a relaxed expanded configuration with a diameter that is greater than the outer diameter (OD) of the elongate inversion support catheter; in addition, the flexible tube may also be configured (e.g., by heat setting, etc.) so that when the flexible tube is everted and rolled over the distal end opening into the elongate inversion support catheter, the outer diameter of the flexible tube within the elongate inversion support catheter has an outer diameter that is about y times (y fold) the inner diameter of the elongate inversion support catheter (e.g., where y is greater than 0.1×, 0.5×, 0.6×, 0.7×, 0.75×, 0.8×, 0.9×, 1×, etc. the inner diameter, ID, of the elongate inversion support catheter. This combination of an un-inverted diameter of the flexible tube of greater than the diameter of the OD of the elongate inversion support catheter and an inverted diameter of the flexible tube of greater than, e.g., 0.7× the ID of the elongate inversion support catheter is surprisingly helpful for preventing jamming of the apparatus, both when deploying the apparatus and when rolling the flexible tube over the distal end opening of the elongate inversion support catheter to grab a clot. The flexible tube may be expandable and may be coupled to the puller as shown. In some variations the flexible tube and the puller may comprise the same material but the flexible tube may be more flexible and/or expandable, or may be connected to elongate puller (e.g., a push/pull wire or catheter). As mentioned above, the puller may be optional (e.g., the flexible tube may itself be pulled proximally into the inversion support catheter).
[0043] In FIG. 1C the clot may be drawn into the elongate inversion support catheter by pulling the flexible tube proximally into the distal end of the elongate inversion support catheter, as indicated by the arrows 113, 113′ showing pulling of the inner portion of the flexible tube, resulting in rolling the flexible tube over the end opening of the catheter and into the catheter distal end and inverting the expandable distal end region so that it is pulled into the catheter, shown by arrows. The end of the flexible tube outside of the catheter may be loose relative to the outer wall of the catheter.
[0044] FIGS. 2A-2C illustrate an example of an apparatus 200 including a flexible tube that extends down the majority of the length of the inversion support catheter. In FIG. 2A, the flexible inversion support catheter 202 and flexible tube 206 are assembled with the flexible tube attached at the distal end region of the puller 204. The apparatus may be long (e.g., 50 cm or greater, 75 cm or greater, 90 cm or greater, 100 cm or greater, 110 cm or greater, 120 cm or greater, 150 cm or greater, etc.). FIGS. 2A-2C show the proximal ends of the inversion support catheter 202, which may include a hub region 212. The puller 204 is slideable within the inversion support catheter and may also include a hub 214. FIG. 2B also illustrates one example of a sheath 208 and the use of the sheath to insert the device through the skin 211 into the patient's body lumen (e.g., vessel). In FIG. 2B, the sheath (introducer sheath 208) is shown straight, but may be curved, and includes a proximal sheath hub 210. The sheath includes a lumen extending along the length. In some variations the sheath may include a valve.
[0045] In FIG. 2C, the apparatus is shown deployed (similar to FIG. 1C), with the puller retracted/retracting proximally 212 to draw the flexible tube 206 over the distal end opening of the inversion support catheter 202 and into the lumen of the inversion support catheter. This rolling and inverting movement 216 of the flexible tube may draw a material (such as a clot) into the lumen of the inversion support catheter along with the flexible tube. In FIGS. 2A-2C, the length of the flexible tube is somewhat limited by the length of the inversion support catheter. Although the flexible tube may be stretched or pulled somewhat along its length (thereby providing a slightly longer length when inside the inversion support catheter, this may be limited; the flexible tube may be configured (e.g., shape set or otherwise) to prevent it from locking down onto the outer surface of the inversion support catheter, which may otherwise increase the pull force required to drawn the flexible tube into the inversion support catheter, and therefore potentially jam or lock onto the inversion support catheter.
[0046] FIGS. 3A-3C illustrate an example of an apparatus similar to that shown in FIGS. 2A-2C, including a depot 316 for holding a compressed proximal region of the flexible tube 315. The depot may be configured to facilitate the release of the compressed flexible tube with a low release force, and in a manner that prevents snagging or binding of the flexible tube either on the body of the catheter or when rolling and inverting into the catheter. For example, FIG. 3A shows the apparatus 300 including an inversion support catheter 302, and a flexible tube 306. The flexible tube is connected to a puller 304 (optional) that may be used to draw the flexible tube over the distal end opening 309 of the inversion support catheter, as seen in FIGS. 1A-2C. Notably, while the device is illustrated in a linear form, it may be curved. Further, the examples provided herein are not shown to scale, unless otherwise indicated, although the relative relationship between the difference components may accurately reflect the interaction of the various components.
[0047] In FIG. 3A the inversion support catheter may also include a hub 312; the puller may also include a puller hub 314. Within the depot 316, the flexible tube 306 is held in a compressed form (“scrunched”) so that a longitudinal section through the flexible tube forms a folded (e.g., zig-zag or fanfold pattern) in which the flexible tube is linearly compressed along the outside of the inversion support catheter, or over an inner wall of the depot (not shown). In FIG. 3A, the proximal end of the flexible tube within the depot is compressed into a folded (e.g., zig-zag or fanfold) pattern in which the flexible tube scrunched perpendicular to the inversion support catheter; e.g., the path taken by the flexible tube curves perpendicularly away and towards the long axis of the inversion support axis. In some variations these ridges of compressed flexible tube may be separated from adjacent ridges within the inner storage region 317 of the depot 316. For example, the inner storage region 317 may include channels or projections configured to separate the compressed flexible tube and to prevent it from internally snagging or catching within the depot. In some variations the flexible tube within the depot may be arranged for both packing of the flexible tube within the depot as well as to prevent snagging or locking up within the depot or leaving the depot. In any of these variations the depot may be lubricious (e.g., may include a lubricious coating, liner, etc.) and/or may be formed of a lubricous material. In particular the inner storage region of the depot may be lubricous. Alternatively, or additionally, the flexible tube may be coated with or contain a lubricous material to assist it in sliding within the apparatus.
[0048] The depot, which may be referred to herein as a proximal depot or a proximal tube depot, may be formed, at least in part, of a flexible, rigid, or semi-rigid material. In some variations the depot is configured to be rigid over at least a portion of its length, so as to prevent a user from touching the compressed flexible tube within the depot, which may result in disruption of the flexible tube and jamming of the device. For example, the depot may include ridges or struts to support the shape of the depot, even when held by the user, without collapsing or interfering with the compressed flexible tube therein. The proximal end of the depot may be configured as a depot hub 321. The depot hub may be configured to engage (e.g., releasably engage) with the inversion support catheter, e.g., the hub 312 of the inversion support catheter. The depot may be configured to slide along the outside of the inversion support catheter.
[0049] The distal end of the depot may include a distal guide 322 forming the distal end opening of the depot. The distal guide may be configured to guide the flexible tube out of the depot as the flexible tube is unfurled. For example, the distal guide may be an annular opening into the depot that may provide an outer surface that is curved towards the outer surface of the inversion support catheter. In some variations the distal guide is rigid or semi-rigid and centers and supports itself over the inversion support catheter to steer the compressed flexible tube out of the depot distally. The inner surface of the distal guide may be configured to be lubricious, to enhance release of the flexible tube.
[0050] As mentioned, the depot may generally be configured to engage with a sheath. For example, the distal guide may be configured to engage with the sheath (e.g., the sheath hub 310) in a manner that prevents snagging of the flexible tube as it leaves the inner storage region of the depot. Thus, the distal guide may be configured to engage with the introducer sheath to secure the depot to the introducer sheath. For example the depot (e.g., the distal guide of the depot) may be configured to engage over a proximal sheath hub of the introducer sheath (as will be described in FIG. 7B), and/or the depot, e.g., the distal guide portion of the depot, may be configured to engage within a proximal sheath hub of the introducer sheath. FIG. 3C shows the distal guide 322 of the depot engaging with the sheath hub 310. In FIG. 3C, the outer surface of the distal guide fits into the sheath hub. The outer surface of the distal guide region may be configured to mate (e.g., releasably mate) with the sheath hub. In some variations the distal guide is configured to fit into the sheath hub with a friction fit. In some variations the outer surface of the distal guide is configured to lock onto the sheath hub. The attachment between the distal guide and the sheath (e.g., sheath hub) may be configured to prevent a reduction in the diameter of the distal guide. In some variations the sheath may be configured so that the distal guide is configured to open to all the flexible tube to be released from the depot after engaging with the sheath. This may prevent premature release of the compressed proximal end of the flexible tube from out of the depot. In some variations one or more stays may be removed by the engagement between the distal guide and the sheath. In some variations the distal guide may be opened further once engage with the sheath, e.g., sheath hub (e.g., when engaging over and/or into the sheath hub).
[0051] For example, in FIG. 3B the apparatus of FIG. 3A is shown being inserted into the body through a sheath 308 having a sheath hub 310 at the proximal end. The apparatus may be inserted distally 311 into the body through the sheath 308. The inversion support catheter and pusher may be locked together (e.g., via the inversion support catheter hub, not shown). In some variations the depot may be locked (e.g., releasably locked) onto the inversion support catheter, e.g., at the hub 312 of the inversion support catheter. For example, in FIG. 3B, the hub of the depot 321 may be releasably engaged or locked onto the hub 312 of the inversion support catheter. Thus, the assembly may be advanced distally to the material to be removed. This process may be done under visualization (e.g., fluoroscopy) and the distal end of the apparatus may be configured to be imaged (e.g., may include radiopaque features). In some variations, as shown in FIG. 3B, the distal end of the puller may extend distally from the distal opening of the inversion support catheter, and may act (alone or in conjunction with a guidewire) to guide the apparatus to and/or against a material to be removed, such as a clot (not shown).
[0052] FIG. 3C shows the apparatus of FIGS. 3A and 3B being deployed and operated at the clot. The depot may be advanced distally 313 (e.g., over the inversion support catheter, to couple with the sheath 308, as described above. This may allow the inversion support catheter and puller to be collectively or separately advanced distally and/or retracted proximally to position the distal end of the apparatus and/or capture material from the body lumen. For example, in FIG. 3C, the puller 304 is drawn proximally 322 to invert the flexible tube 306 over and into the inversion support catheter 302 so that it rolls 316 into the distal end opening of the inversion support catheter. The inversion support catheter may be separately or concurrently advanced distally. In some variations the distal end of the depot (e.g., the depot distal guide) may be configured to receive the flexible tube from the distal opening when the depot is advanced distally over the inversion support catheter (e.g., without moving the puller proximally). Thus, the depot may be configured to receive “slack” in the flexible tube from the distal end, even while maintaining the compression of the more proximal portion of the flexible tube within the inner storage region of the depot. In some variations the distal guide of the depot may have an outwardly flared distal opening (e.g., a trumpet-shaped distal opening) that may allow the flexible tube to be guided into the distal guide from the distal end.
[0053] FIGS. 4A and 4B illustrate another example of an apparatus as described herein, similar to that shown in FIGS. 3A-3C; in FIGS. 4A-4B, the distal end of the inversion support catheter is configured to have a funnel shape 431, over which the flexible tube may be pulled. Examples of this configuration may be seen, e.g., in U.S. patent application Ser. No. 16/594,256 (titled “INVERTING THROMBECTOMY APPARATUSES AND METHODS OF USE”) filed on Oct. 7, 2019, and U.S. patent application Ser. No. 16/594,259, filed on Oct. 7, 2019.
[0054] For example, the apparatus of FIG. 4A includes an elongate inversion support catheter 402 with the funnel-shaped 431 distal end region, and a flexible tube 406 coupled to a puller 404 within the lumen of the inversion support catheter. In FIG. 4A, the proximal end of the flexible tube 415 is compressed (e.g., scrunched) within the inner storage region 417 of the depot 416. The proximal end of the sheath may include a hub 421 that may be locked or unlocked onto a hub 412 of the inversion support catheter. The puller 404 may also include a hub 414 to help in manipulating the puller and/or for releasably locking to the inversion support catheter. The depot 416 may be configured as described above, including having a distal guide 422 that may engage with a sheath, as shown in FIG. 4B.
[0055] FIG. 4B shows the apparatus 400 loaded through the sheath 408 and into a patient, through the patient's skin 411. In FIG. 4B, the apparatus is shown engaging with a sheath 408. In this example, the sheath includes a hub 410 that may engage with the distal end of the depot, as shown. For example, the distal guide 422 of the sheath may be inserted into the proximal end of the sheath; the depot may be locked onto the sheath, e.g., sheath hub.
[0056] FIGS. 5A-5B illustrate the operation of the apparatus shown in FIGS. 4A-4B to capture a clot material 550. As mentioned above, the thrombectomy apparatuses described herein may be advanced in the vessel by moving the sheath 508 and apparatus 500 together or relative to the sheath 508 as shown in FIGS. 5A and 5B. FIG. 5A shows a potential starting position, while FIG. 5B shows the apparatus manipulated to ingest material by advancing the inversion support catheter 502 within the sheath while optionally pulling the puller 504 proximally. In FIG. 5A the inversion support catheter 502 may be locked to the depot, e.g., by a lock (such as a locking mechanism including one or more of: a valve, a clamp, etc.) on the depot, such as the depot hub that releasably locks on to the elongate body of the inversion support catheter 502. A control (e.g., button, knob, etc.) on the depot may be used to engage/disengage the depot from the elongate inversion catheter. In FIG. 5B the depot 516 may be released from a lock and free to move relative to the elongate inversion support catheter, in this case, allowing the elongate support catheter to be advanced distally 560 as shown. The puller 504 may be pulled proximally 570 at the same time. As a result, the flexible tube 506 may be rolled over the distal end of the inversion support catheter, capturing the material 550, as shown. Any of the apparatuses describe described herein may include a lock that releasably locks the depot to the inversion support catheter.
[0057] In any of the apparatuses described herein, the flexible tube material may be compressed within the depot and secured in a compressed form. In some variations the flexible tube may be a woven tube (e.g., a plurality of woven strands) and/or a knitted tube (one or more knit strands), etc. In the examples shown, the compressed flexible tube may be compressed at a high degree of packing efficiency. For example, in FIGS. 3A-5B, the depot may hold flexible tube material at a 20 to 1 packing efficiency (e.g., a 10 cm long depot could be filled with 200 cm of scrunched flexible tube).
[0058] FIGS. 6A-6B illustrate one example of a flexible tube material 609 that is shown compressed on a mandrel from a length of 40 cm to a length of 2 cm. FIG. 6A shows the knit material that may be part of a flexible tube compressed down on a 12.5 mm mandrel; in FIG. 6B this compressed flexible tube has been annealed (e.g., via temperature setting) to retain the compressed configuration. In some variations, after forming the material (e.g., knitting, weaving, etc.) of the flexible tube, the material can then be shape set (e.g., heat set) to any radial diameter (e.g., between 1-30 cm OD). Next, the flexible tube can be loaded on a mandrel of equal or small diameter of the heat set diameter, and compressed linearly. For example, the flexible tube may be compressed axially so it randomly scrunches. Alternatively, in some variation, a compression guide may be provided to compress the flexible tube in a predictable manner. For example, a wire can first be wound around the uncompressed flexible tube on the mandrel (i.e., in a helical pattern) at a given pitch and then the flexible tube and helical wire may be compressed axially (“scrunched”), so the flexible tube is scrunched at the points the wire contacts the flexible tube. The flexible tube may then be set (e.g., heat set) in this scrunched configuration. The helical wire may be removed before, during or after enclosing in the depot. In some variations the material may be loaded into a depot in the compressed form including a compression guide (such as the helical wire describe above), with or without shape setting; the compression guide may hold the flexible tube in a compressed form. Once enclosed in the depot, which may itself hold the compressed form, the compression guide may be removed.
[0059] In some variations, before the compressed flexible tube is loaded in the depot, and to prevent snagging/catching of the flexible tube when unfurling from the depot (e.g., when pulled out of the depot guide region of the depot), in some a film, fabric or other layer of material may be included on or in the flexible tube (including the helical wire discussed above), such as on the outside or inside of the flexible tube, that may act like a release, preventing two adjacent compressed regions (e.g., peaks of the fanfold and/or zig-zag shaped flexible tube) from contacting each other within the depot.
[0060] In some variations the apparatus may be configured so that the flexible tube is modified after it is compressed, e.g., by twisting, rotating, turning, etc. to further compress and/or to load into the depot. For example, in some variations the compressed (e.g., scrunched) flexible tube is twisted along its length (e.g., clockwise and/or counterclockwise) on the inversion support catheter, or a mandrel, prior to being enclosed in the inner storage region of the depot. Thus, in some variations the flexible tube within the depot is compressed as described herein and may be further twisted.
[0061] Any of the flexible tubes described herein may not be shape-set into the compressed configuration. For example, the flexible tube may be heat set to the radius of or slightly larger than the inversion support catheter in the un-inverted (and in some variations an inverted radius may be set, as described above), in a straight/uncompressed configuration, and then compressed and held in the depot. This may reduce the friction will pulling knit out of the depot.
[0062] FIG. 7A illustrates one example of an apparatus 700 as described herein, similar to that shown above, in which the depot 716 includes an inner lining 771 within the inner storage region 707. The inner lining may extend over and around the inversion support catheter, and may be rigid or semi-rigid. This inner lining may also be lubricous.
[0063] The depot 716 in FIG. 7A also includes a flushing valve 733 that may be used, for example, for connection to a fluid (e.g., saline) for flushing the depot during or before use. In some variations the depot includes a hub 721 that may engage with the inversion support catheter 702. The sheath 708 (including sheath hub 710) may be configured to engage with the depot (e.g., a distal guide 722 of the depot). In some variations this may be a locking engagement (e.g., a releasable locking engagement). This engagement may be water or pressure-tight (e.g., the depot and the sheath may be sealingly engaged). In any of the variations described herein the depot may be pressurized (e.g., by including a pressurized fluid, which may help unfurl the flexible tube 706 when it is pulled distally out of the depot, e.g., by pulling on the puller 704. In some variations a saline may be injected via the port 733; in some variations, a contrast agent may be introduced through the depot via the same or a different port. Alternatively, or additionally, a lubricant may be injected through the depot. As mentioned, the depot can be pressurized with saline or other fluids to produce a positive pressure, which may reduce or stop retrograde patient blood flow into the depot.
[0064] In FIG. 7A the distal guide 722 of the depot 716 engages with the sheath 708 by inserting into the sheath. FIG. 7B illustrates an example in which the distal end 722 of the depot 716 engages with the sheath 708 by attaching over the sheath. Coupling the depot to the sheath over the sheath may reduce any potential pinch points as the flexible tube unfurls through the sheath. The depot to sheath junction may be sealed in some configurations.
[0065] As mentioned above, the flexible tube may be any appropriate material, such as a knit, a weave, a braid, or a non-woven material (both solid and/or laser slotted). In some variations the flexible tube comprises a metallic material, a polymeric material, and/or mixes of the two. In general, to reduce the friction in the system as the weave is unfurled out of the depot and through the sheath, the depot can be made from a slippery material such as PTFE, PE, hard polymer. Alternatively, or additionally, the weave can be coated with a lubricious coating, and/or the depot inner chamber can be coated with a lubricious coating.
[0066] In general, the length of the distal end (e.g., distal guide) of the depot can be any length, and may be funnel-shaped or tapered at either or both ends. In some variations the distal end of the depot can be made from PTFE or lubricious coating. For example, FIGS. 8A and 8B illustrate two examples of apparatuses including depots having distal guide regions that are longer. The longer distal guide regions may help maintain the compressed form of the flexible tube and may protect and constrain the flexible tube along much of the length of the inversion support catheter, as shown. For example, in FIG. 8A, the apparatus 800 includes an inversion support catheter 802, and a flexible tube 806 coupled to a distal end region of a puller 804. The apparatus is inserted through the sleeve 808 into the body. In this example the distal guide region 822 of the depot 816 extends much further than the introducer sheath 810. Although FIGS. 8A and 8B show the distal guide region extending down much of the length of the inversion support catheter, in some variations, the distal guide region extends between 85% and 20% the length of the inversion support catheter (e.g., 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, etc.). In FIG. 8A, the apparatus is undeployed; FIG. 8B shows the apparatus of FIG. 8A in a deployed configuration, by driving the inversion support catheter distally 860 and/or pulling the puller 804 proximally. The short introducer sheath 808 may include a proximal end (e.g., proximal hub 810) that engages with the depot 816. In FIG. 8B, the distal end of the apparatus is inserted through the sheath to clot face, and the distal funnel region 831 may be extended and expanded outwards.
[0067] In any of the variations described herein, the proximal end of the sheath, e.g., outside of the patient, may be larger in diameter than more distal regions in order to remove pinch point and connect to a wider mouth depot connection junction point. In some variations the sheath may have a wider mouth with a funnel taper to make the flexible tube deploy with less friction into a smaller sheath ID inside the patient.
[0068] Although the majority of the examples described above include the flexible tube compressed linearly within the depot, in some variations the flexible tube may be compressed in one or more alternative ways. For example, in FIG. 9 the depot 916 includes a layered structure within the inner storage region of the depot, which is divided up into multiple layers 913 to hold the flexible tube 906. The device also includes an inversion support catheter 902 and a puller 904 as described above.
[0069] Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like.
[0070] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
[0071] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
[0072] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
[0073] Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
[0074] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
[0075] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as “consisting of” or alternatively “consisting essentially of” the various components, steps, sub-components or sub-steps.
[0076] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
[0077] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
[0078] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
