Self-expanding scaffold structures for thrombectomy and / or thrombolysis catheter systems, devices and methods

Abstract

Self-expandable scaffold devices are disclosed. In some embodiments, the devices comprises a series of helically arranged tubes or wires connected with a distal slidable element that is axially translatable, or slidable along a tubular body to relieve expansion and compression forces. In some embodiments, the devices comprise a series of helically arranged tubes or wires that comprise a distal end region that is tapered inward toward a central axis of the tubular body.

Description

TITLE OF THE INVENTIONSELF-EXPANDING SCAFFOLD STRUCTURES FOR THROMBECTOMY AND / ORTHROMBOLYSIS CATHETER SYSTEMS, DEVICES AND METHODSINVENTORSJonathan Paul, Chicago, IL, a citizen of the United States of AmericaOsmanuddin Ahmed, Northbrook, IL, a citizen of the United States of AmericaJennifer Fried, Highland Park, IL, a citizen of the United States of AmericaAlexander McCall, San Diego, CA, a citizen of the United States of AmericaBridget Bergstrom, San Diego, CA, a citizen of the United States of AmericaSpencer Ross, San Diego, CA, a citizen of the United States of AmericaCROSS-REFERENCE TO RELATED APPLICATIONSThis application claims priority to Provisional Application No. 63 / 675,333, filed July 25, 2024 and titled SELF-EXPANDING SCAFFOLD STRUCTURES FOR THROMBECTOMY AND / OR THROMBOLYSIS CATHETER SYSTEMS, DEVICES AND METHODS, the entire content of which is incorporated herein by reference.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENTNone

[0001] FIELD OF THE INVENTION

[0002] The present disclosure relates to scaffolds for thrombectomy and / or thrombolysis catheter systems, devices and methods.

[0003] BACKGROUND

[0004] Figure 1 shows a prior art clot disruption device 10 with an outer sheath 12 defining a lumen through the length of the outer sheath 12 and within which is disposedcatheter body 14 also defining a lumen 16 therethrough. A tubular body 18 is received within lumen 30. A distal nose cone 20 is fixed to a distal end of the tubular body 18, such that the distal nose cone 20 maintains its axial position relative to the tubular body 18. Tubular body 18 also defines a lumen 22 though which a guidewire (not shown), for example, may be received. Tubular body 18 defines ports or apertures 24 through which fluid such as a lytic agent may be discharged. The fluid may be provided to the ports or apertures 24 through lumen 22 and / or through additional fluid lumen(s) that may be provided and in fluid communication with the ports or apertures 24. An self-expandable cage 26 is provided with a connection at a distal end of the self-expandable cage 26 to the distal nose cone 20 and, as illustrated, a proximal end of the self-expandable cage 26 is connected to tubular body 18 at a point, as shown, within the lumen of catheter body 14. Self-expandable cage 26 may comprise a series of straight or helical wires. A macerator 40 is disposed along the tubular body 18 and within the self-expandable cage 26. Because the catheter body 14 is axially moveable relative to the tubular body 18, distal slidable element 28 and the distal end of the expansible cage 26, the self-expandable cage 26 may be expanded by moving tubular' body 18 in a distal direction, relative to the catheter body 14 to release the collapsed and compressed expansible cage 26 from the restraints of the lumen 16 of the catheter body 14. Similarly, the self-expandable cage 26 may be compressed and contracted by moving the tubular- body 18 in a proximal direction relative to the catheter body 14 to compress the self-expandable cage 26 within the constraining lumen 16 of the catheter body 14. This arrangement requires the wires comprising the self-expandable cage 26 to be compressed within the lumen 16 of the catheter body 14, creating unnecessary stress forces on the wires of the self-expandable cage 26 as well as on the inner walls 14 defining the lumen 16 of the catheter body 14. In addition, an operator will be required to exert enough force to deform and compress the self-expandable wires of the self-expandable cage 26 within the lumen of the catheter body 14. The prior art design can be improved to address at least these issues.

[0005] Figure 2 illustrates another prior art clot disruption device 30 comprising a catheter body 32 defining a lumen therethrough. A tubular body 34, similar to that of Fig. 1 is slidably disposed within the lumen of the catheter body 32. Four helically arranged self-expandable wires or struts 36 with a proximal end and a distal end areconnected at the distal end to a distal nose cone 38. The proximal end of the wires or struts 36 arc connected with the tubular body 34. The sclf-cxpandablc wires or struts 36 are configured to expand radially similar to the device 10 of Fig. 1. The tubular body 34 is connected with a proximal end of the wires or struts 36, and the distal end of the selfexpandable wires or struts 36 are only connected with the distal nose cone 38. As a result, the distal nose cone 38 and the self-expandable wires or struts 36 are not fixed in position relative to the tubular body 34, but instead are unsupported and configured to float as the skilled artisan will readily understand. Similar to the device 10 of Fig. 1, proximally applied force is required to collapse and compress the radially expanded wires or struts 36 into the lumen of the tubular’ body 34. There is no thrombolytic capability or structure associated with the device 30 of Fig. 2. The device 30 of Fig. 2 thus comprises similar issues to those discussed above regarding the device 10 of Fig. 1.

[0006] It would be advantageous to provide a thrombus or clot disruption device configured to perform thrombectomy and / or thrombolysis and comprising a distal slidable element that is supported and not floating, but also not fixed in position relative to a tubular’ body, catheter body or sheath body. It would be further advantageous to provide a thrombus or clot disruption device with a distal slidable element that is proximal to an atraumatic tip configured to aid in traversing tortuous vasculature and navigating across a thrombus and / or clot of interest.

[0007] It would also be advantageous to provide a scaffold for clot disruption that is configured to perform thrombectomy and / or thrombolysis that does not include a distal slidable element, but does comprise a distal tapering end of a plurality of wire struts, that may or may not be operatively connected or associated with each other, to help avoid the problem of individual struts passing undesirably into side branches of the vasculature during advancement of the device to the thrombus and / or clot of interest.

[0008] SUMMARY

[0009] The present invention provides scaffold, or cage, structures for use in removal of thrombus and / or clots from vasculature and / or at least partial lysis of thrombus and / or clots within vasculature.

[0010] As described in more detail below, the embodiments of the scaffold structure areoperatively connected or associated with a catheter body with a proximal end, a distal end, and a plurality of lumens therethrough. One or more of the lumens arc operatively, or fluidly connected or associated with one or more fluid reservoirs. The one or more fluid reservoirs may contain, separately, a contrast fluid, a fluid comprising at least one lytic agent, and / or saline. Another lumen may be provided through the catheter body sized to allow a guidewire to be received therein and translated through the lumen and / or allowing the catheter body to be translated along a guidewire that is prepositioned at or near a thrombus or clot of interest within the vasculature.

[0011] Various embodiments of the scaffold structure may comprise wire struts that are operatively connected or associated at a proximal end with the catheter, or other tubular, body, and further operatively connected or associated at a distal end with a distal slidable element. In some embodiments, the scaffold structure is self-expanding. In some embodiments, the scaffold structure comprises a distal slidable element to which the wire struts are operatively connected or associated. In some embodiments, the catheter, or other tubular, body extends distally beyond the distal slidable element, wherein the distal slidable element is configured and sized to receive the catheter, or other tubular, body through a central aperture. In some embodiments, a distal-most atraumatic tip is associated or operatively connected with a distal end or distal region of the catheter, or other tubular, body. In some embodiments, the distal slidable element is configured to slide axially along the catheter, or other tubular, body as the self-expanding scaffold structure expands and / or is contracted. In some embodiments, the wire struts may uniformly surround the catheter, or other tubular, body. In some embodiments, each wire strut is spaced apart from adjacent wire struts. In some embodiments, individual pairs of wires struts may be operatively connected or associated at the slidable element and, in some embodiments, at the proximal connection or association of the wire struts with the catheter, or other tubular, body. In some embodiments, each wire strut may be helically arranged about the catheter, or other tubular, body and / or guidewire. In some embodiments, the distal slidable element may comprise a metal, or in other embodiments may comprise a polymer material.

[0012] In some embodiments, a plurality of single wire struts may be helically arranged about the catheter, or other tubular, body, beginning at the proximal connection orassociation of each single wire stmt, or proximal end, in the plurality of single wire struts, wherein each single wire strut extends helically and distally to a distal end, wherein the single wire strut is configured to turn at the distal end and extend helically and distally back to the proximal end, thus forming effectively a double stmt from a single wire. In some of these embodiments, a distal region of each single wire structure may be formed or shaped or biased to taper down toward the catheter, or other tubular, body. In some of these embodiments, a distal region may be formed into a loop structure that necks down proximally before beginning the helical proximal return to the proximal end. In some of these embodiments, a rigid, or flexible, marker band comprising a ring-shape that may be connected with the distal ends of the wire struts.

[0013] In some embodiments, the helically arranged wire struts may be operatively connected or associated with each other at one or more points between the proximal and distal ends of the wire struts. In some embodiments, the operative connection or association may comprise a weld or other connection or association method.

[0014] In some embodiments, a distal end of the wire stmts may be operatively connected or associated with each other. In some embodiments a distal region of the operatively or associated distal ends of the wire struts may taper down towards one or more connections or associations of the distal ends of the wire stmts. The connections or associations of the distal ends may comprise one or more welds or one or more wires interconnected between the distal ends. In some of these embodiments, a passage through the associated or connected distal ends of the wire struts is defined to allow passage or reception of the catheter body and / or guidewire.

[0015] In some embodiments, the scaffold stmeture may comprise wire stmts formed of a tube structure comprising an inner lumen that is in fluid, or operative, connection or association with one or more of the plurality of lumens of the catheter body. In some embodiments, the scaffold stmeture may comprise wire stmts with a plurality of pores or apertures through an outer wall of the tube structure, allowing fluid within the inner lumen to discharge through the plurality of pores or apertures to interact with a thrombus and / or clot of interest.

[0016] Some embodiments of the scaffold stmeture may be associated with, or use,certain design principles of the catheters, and associated systems and methods, as described in WO 2023 / 288268, entitled “Multi-Function Catheter and Methods and / or Treatment of Venous Thromboembolic Disease”. Figure 3 illustrates a prior ail thrombus or clot disruption device 40 that is disclosed in WO 2023 / 288268. The device 40 comprises a catheter body 42 defining a lumen therethrough and is configured to receive a tubular body 44 therein. The catheter body 42 and the tubular body 44 are axially moveable relative to each other. Three helical wires or tubes 46 are provided and connected at a proximal end with the tubular body 44, and are configured to return back to connect at a distal end with the tubular body 44, thereby creating a scaffold structure of six helical wire structures. The helical wire or tube 46 structure is self-expanding. As a result, the helical wire or tube 46 structure may be compressed within the lumen of the catheter body 42 that is disposed around the I ubnlar body 44. The helical wire or tube 46 structure may achieve a self-expanded configuration by either pushing pulling the catheter body 42 in a proximal direction. This prior art device 40 does not include a distal slidable element, but instead comprises an open distal end, wherein a distal region of the wires or tubes 46 are axially aligned with, or parallel to, a longitudinal axis A of the tubular body 44. Similar issues exist with the radial compression of this device 40 as described above in connection with Figs. 1 and 2. Moreover, the open distal end combined with the distal region of the wires or tubes 46 axially aligned or parallel to the longitudinal axis A of the tubular body 44 presents risk that one or more of the distal ends of the wires or struts 46 may become caught within a side branch of the vasculature during advancement to a thrombus and / or clot.

[0017] It is also known from WO 2023 / 288268 that a scaffold structure of a thrombectomy and / or thrombolysis device such as that of Fig. 3 may comprise tubes 46 that may be formed of a shape memory material, e.g., nitinol, to allow a self-expanding scaffold structure. The self-expandable tubes 46 of such a scaffold may include a plurality of ports along at least part of the tube length to allow a thrombolytic agent to flow from a lytic agent reservoir, through a lumen, or a plurality of lumens disposed along either the catheter body 42 or the tubular body 44, through the ports and into a thrombus or blood clot.

[0018] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0019] The patent application contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.

[0020] These drawings are exemplary illustrations of certain embodiments and, as such, are not intended to limit the disclosure.

[0021] FIGURE 1 illustrates a side view of a prior art device.

[0022] FIGURE 2 illustrates a perspective view of a prior art device.

[0023] FIGURE 3 illustrates a side view of a prior ail device.

[0024] FIGURE 4 is a side photo image of a distal region of one embodiment according to the present disclosure.

[0025] FIGURE 5 is a side photo image of the embodiment of FIG. 4.

[0026] FIGURE 6 is a side photo of the embodiment of FIGS. 4 and 5.

[0027] FIGURE 7 illustrates a cutaway end view of a portion of an embodiment according to the present disclosure.

[0028] FIGURE 8 illustrates a cutaway end view of a portion of an embodiment according to the present disclosure.

[0029] FIGURE 9 is a side photo of a distal region portion of an embodiment according to the present disclosure.

[0030] FIGURE 10 is a side photo of a distal region of the embodiment of FIGS. 4-6.

[0031] FIGURE 11 is a side close-up photo of the embodiment of FIG. 10.

[0032] FIGURE 12 is a side view of an embodiment of a distal slidable element according to the present disclosure.

[0033] FIGURE 13 is a side view of one embodiment of the present disclosure.

[0034] FIGURE 14A is a cutaway side view of a distal end region of one embodiment according to the present disclosure.

[0035] FIGURE 14B is a cutaway side view of a distal end region of a prior art device.

[0036] FIGURE 15A is an end view of one of one embodiment according to the present disclosure.

[0037] FIGURE 15B is a side view of a distal end of a tube or wire loop according to the present invention.

[0038] FIGURE 15C is an end view of one of one embodiment according to the present disclosure.

[0039] FIGURE 15D is a side view of a distal end of a tube or wire loop according to the present invention.

[0040] FIGURE 16A is an end view of one embodiment according to the present disclosure.

[0041] FIGURE 16B is an end schematic view of the embodiment of Figure 16A.

[0042] FIGURE 17 is a side view of one embodiment according to the present disclosure.

[0043] DETAILED DESCRIPTION OF THE INVENTION

[0044] Referring now to the drawings generally, and specifically to Figs. 4-6, a scaffold device or system 100 is shown in an expanded configuration. A scaffold structure 101 comprising a series of self-expandable tubes, or wires 102, are helically configured about a tubular body 104. And, as best seen in Fig. 6 and 10, and with additional reference to Fig. 8, the self-expandable tubes or wires 102 are arranged about the tubular body 104 in a paired configuration. In some embodiments, three self-expandable tubes or wires 102 comprising a proximal end and a distal end are provided. As will be discussed further, each one of the self-expandable tubes or wires 102 may comprise comprises a first length that extends in a distal direction, a second length that extends in a proximal direction, and a transitional section between the first length and the second length. In this configuration, the scaffold device or system 100 comprises a helical structure comprising six self-expandable tubes or wires 102. In other embodiments, six individual tubes or wires extending from a proximal connection of the scaffold device or system to a distal connection of the scaffold device or system may be provided.

[0045] A tapered section 106 is provided at a first distal region of the self-expandable tubes or wires 102, leading to a transition section or region 108. The transition section orregion 108 turns the self-expandable tubes or wires 102 from the taper of the tapered section 106 to a substantially straight, or flat, configuration along the flat section 110. At least part of the flat section 110 is substantially parallel with a central axis A of the tubular body 104. The flat section 110 of the self-expandable tubes or wires 102 terminates at a distal slidable element 112, which at least partially surrounds the tubular' body 104. A distal portion of the flat section 110 of the self-expandable tubes or wires 102 are operatively connected or associated with the distal slidable element 112.

[0046] The distal slidable element 112 is configured to slide axially along the tubular body 104 to accommodate the expansion and compression forces on the scaffold structure 101 during transition of the scaffold structure 101 to achieve a compressed, collapsed configuration within a lumen of an outer sheath, or an expanded configuration as the selfexpanded tubes or wires 102 of the scaffold structure 101 are released from the constraining lumen of the outer sheath.

[0047] When the self-expanded tubes or wires 102 of the scaffold structure 101 are in a compressed, collapsed configuration within the lumen of an outer sheath, the distal slidable element 102 translates distally along the tubular body 104 to accommodate the compression forces placed on the self-expanded tubes or wires 102. Similarly, release of the self-expandable tubes or wires 102 of the scaffold structure 101 from the constraints of a lumen of an outer sheath results in self-expansion of the self-expandable tubes or wires 102. The distal slidable element 112 translates in a proximal direction along the tubular body 104 to accommodate the expansion force of the scaffold structure 101. As a result of the translating accommodation of the distal slidable element 112, the scaffold structure 101 changes in length from a relatively longer length when in a compressed, collapsed configuration, to a relatively longer length when in an expanded configuration.

[0048] The translating accommodation of the distal slidable element 112 provides for a much easier transition between compressed, collapsed configurations and expanded configurations for the scaffold structure 101. Thus, less force is required to be placed on the device 100 by an operator during the transition from a compressed, collapsed configuration to an expanded configuration, or from an expanded configuration to a compressed, collapsed configuration.

[0049] The scaffold device 100 of Figs. 4-6 further illustrate that the tubular structure 104 extends distally beyond the distal slidable clement 112, terminating at an atraumatic tip that tapers in the distal direction. The tubular structure 104 and the atraumatic tip each comprise a lumen therethrough, wherein the lumens are aligned to allow traversal of, or over, a guide wire 116 as in Fig. 5.

[0050] Figures 7 and 8 illustrate the self-expandable tubes or wires 102 within the flat region 110 discussed above. Figure 7 illustrates one embodiment, wherein the selfexpandable tubes or wires 102 are equally spaced apart from each other around the tubular body 104, though a non-equal spacing is within the scope of the present invention. Figure 8 illustrates a more preferred embodiment wherein the self-expandable tubes or wires 102 are configured into pairs at the flat region 110. As best shown in Figures 6 and 10, the self-expandable tubes or wires may 102 be configured into pairs within the tapered section 106, and continue as pairs through the flat section 110. At the distal end of the flat section 110, the self-expandable tubes or wires 102 are operatively connected or associated with the distal slidable element 112. As shown, the pairs of selfexpandable tubes or wires 102 are spaced equally apart around the tubular body 104, though non-equal spacing is within the scope of the present invention.

[0051] Figures 4-8 illustrate embodiments wherein at least some of the thrombus or clot material may be captured within the self-expandable tubes or wires 102 following a selfexpansion and retraction or collapsing of the self-expandable tubes or wires 102. The operative connection or association of the distal ends of the self-expandable tubes or wires 102 and the distal slidable element 112 help retain the thrombus or clot material for subsequent removal.

[0052] Figure 9 illustrates an alternate embodiment wherein the self-expandable tubes or wires 102 are configured into pairs, but as illustrated, the flat section 110 is omitted. Thus, the self-expandable tubes or wires 102 are configured along a tapered section and at the end of the tapered section are operatively connected or associated with the distal slidable element 112.

[0053] Figure 11 illustrates a close-up view of one embodiment of a distal slidable element 112 and the operative connection or association of the distal end of the self-expandable tubes or wires with the distal slidable element 112. The illustrated connection is achieved by welding, though other connection or association methods arc known to the skilled artisan and are within the scope of the present invention.

[0054] Figure 12 illustrates one embodiment of a distal slidable element 112 comprising a cylindrical wall W defining a lumen L and a cutout C through a portion of the wall W. The distal slidable element 112 is illustrated as cylindrical, and the cutout C is illustrated as rectangular. The skilled artisan will readily recognize additional shapes for both the distal slidable element 112 and the cutout C, all of which are within the scope of the present invention. There may be one cutout C defined by the wall W of the distal slidable element 112. Alternatively, there may be more than one cutout C defined by the wall W of the distal slidable element 112, wherein adjacent cutouts C are spaced apart, either equally or unequally. The cutout(s) C may be configured to allow at least a portion of the expandable tubes or wires 102 to reside within the cutout(s) C, where the operative connection or association may be provided. Provision of the cutout(s) C allows for the assembly comprising the distal slidable element 112 and the connected or associated selfexpandable tubes or wires 102 to maintain the lowest crossing profile possible.

[0055] An alternate embodiment of a distal slidable element 112 may not comprise cutout(s) C. In this embodiment, the distal ends of the self-expandable tubes or wires 102 may be connected or associated with the distal slidable element 112 along an outer surface of the distal slidable element. In addition, the illustrated distal slidable element 112 comprises a ring, or ring-like structure that surrounds and slides along, or translates along, the tubular body 104. Other embodiments of the distal slidable element 112 will also now present themselves to the skilled artisan, each of which are within the scope of the present disclosure. Thus, for example and without limitation, a distal slidable element 112 may not completely surround the tubular body 104 while still connecting with the distal ends of the self-expandable tubes or wires 102 and configured to slide, or translate, along the tubular body 104. Accordingly, different shapes than the illustrated complete cylinder or ring may be used to accomplish the objectives of the distal slidable element 112, each of which is within the scope of the present invention.

[0056] Figure 13 illustrates an alternate embodiment of the scaffold device or system 100described above. In this embodiment, the scaffold device or system 100’ comprises a tubular body 104 with an exemplary helical scaffold of sclf-cxpandablc tubes or wires 102 surrounding a distal region of end of the tubular body 104 as described above. An optional distal slidable element 112 is provided as described above and wherein the tubular body 104 extends through the exemplary helical scaffold of expandable tubes or wires 102, and further extends distally past the distal slidable element 112, finally terminating in an atraumatic tip 114. In the illustrated embodiment, a screen 120, which may comprise a mesh or braided or other structure, is shown disposed along a distal region of the scaffold device or system 100, which may extend from the atraumatic tip 114 (or from a point proximal of the atraumatic tip) to a point distal of the proximal ends of the self-expandable tubes or wires 102. This embodiment also works to capture at least some of the thrombus or clot material may be captured within the self-expandable tubes or wires 102 following a self-expansion and retraction or collapsing of the selfexpandable tubes or wires 102. The screen 120 helps retain thrombus or clot material within the boundaries of the screen 120.

[0057] The screen 120 may comprise openings that are smaller in size than the openings defined by the exemplary helically arranged self-expandable tubes or wires 102, thus providing a mechanism to capture thrombus or clot material. In one embodiment, the screen 120 may be attached around an outer surface of the expandable tubes or wires 102. In another embodiment, the screen 102 may be attached around an inner surface of the expandable tubes or wires 102. In some embodiments, the distal end of the screen 102 may be connected with, or just proximal to, the atraumatic tip 114, as illustrated in Fig. 13. In other embodiments, the distal end of the screen may be connected to the slidable element 112. As shown, a distal portion of the helical expandable tubes or wires 102 is associated with the screen 120. hi other embodiments, the screen 120 may be associated along part or all of the exemplary helical self-expandable tubes or wires 102, such that when the self-expandable tubes or wires 102 either expand or contract or collapse, the screen 120 also moves to expand or contract or collapse with the self-expandable tubes or wires 102.

[0058] In some embodiments, the screen 120 may be positioned at a point that is within the thrombus or clot, or may be positioned at a point that is at least partially distal withthe thrombus or clot. If the screen 120 is positioned within the thrombus or clot, upon expansion of the self-expandable tubes or wires 102, at least a portion of the thrombus or clot material may pass through the openings of the screen 120 and be retained within the boundaries of the screen 120 for subsequent collapsing of the self-expandable tubes or wires 102 and removal from the blood vessel along with the retained thrombus or clot material.

[0059] If the screen 120 is positioned at least partially distal to the thrombus or clot, then the tubular body 104 and screen 120 may be retracted in the proximal direction to capture at least some of the thrombus or clot material within the boundaries of the screen 120, followed by subsequent collapsing of the self-expandable tubes or wires 102 and removal from the blood vessel along with the retained thrombus or clot material.

[0060] The embodiments discussed above in relation to Fig. 13 may be provided as a mechanical thrombectomy device or system, a thrombolysis or thrombolytic device or system as described above, or a combination mechanical thrombectomy and thrombolysis or thrombolytic device or system.

[0061] All embodiments described above require less force to move between compressed, collapsed and expanded configurations than known devices as a result of the presence of the distal slidable element 112. In addition, the embodiments described above do not result in portions of the expandable structure being undesirably caught in side branch vasculature.

[0062] Turning now to Figures 14A and 14B, and with reference to prior art device of Figure 3, an improved thrombectomy and / or thrombolytic scaffold device 200 is illustrated and compared with the prior art device 40 of Fig. 3. An end region of the prior art device 40 is illustrated for comparison purposes in the upper image of Fig. 14A. The end regions of the self-expanding tubes or wires 46 are, as best seen in Fig. 3, substantially parallel with a central axis of the tubular device 44. As noted supra, this prior art device is prone to having individual ones of the end loops L formed at the distal most ends of each individual helically wound and self-expanding tube or wire 46, becoming undesirably caught within side branch vasculature during advancement of the device 40.

[0063] An embodiment of the improved thrombectomy and / or thrombolytic scaffold device 200 is shown in the lower image of Fig. 14 A, and in Fig. 14B. As shown, a distal region 202 of the individual ones of the self-expanding tubes or wires 46’, with distal- most loops L’, are tapered inward toward central axis A’. A tubular body and / or guidewire may still be accommodated through the tapered distal region 202. As a result of the taper, the self-expanding tubes or wires 46’ of the distal region 202 are protected from becoming caught within side branch vasculature during advancement.

[0064] With continued reference to Figures 14A and 14B, an alternate embodiment is shown in Figures 15A and 15B, wherein the distal region 202 is tapered as in Figure 14B, but tapered more so as to bring the individual distal-most loops L’ into contact where they are operatively connected or associated as in the end view of Fig. 15 A. A series of connections 204, made, for example and without limitation, by welding processes, provide a scaffold structure with a distal end region that is secure and without disconnected loops L that may become deformed or otherwise caught by vascular structures. The loops L’ are connected or associated so as to allow a lumen therethrough for a tubular body and / or guidewire. As illustrated, loops L’ comprise a radiused end 206, e.g., circular, that transitions to a more proximal necked down region 208. Figure 15B illustrates one shaping embodiment for distal loops L’, though other shapings are within the scope of the present disclosure as will be readily apparent to the skilled artisan.

[0065] Figures 15C and 15D provide an alternate embodiment to that of Figs. 15A and 15B. The distal -most loops L” of Figs. 15C and 15D comprise an exemplary elliptical shape, without a more proximal necked-down region as in Figs. 15A and 15B. As a result, the connections or associations 204’ between loops L’ ’ form a structure as shown in Fig. 15D. A guidewire lumen is provided or defined at an open central region between the connected or associated loops L” as shown.

[0066] Figures 16A and 16B illustrate another embodiment of a scaffold structure 300, similar to those Figures 14A-15D, wherein the distal loops L’ are threaded with a connecting wire 302 or similar structure, for example, a nitinol wire may be used. As shown, the connecting wire 302 is threaded through adjacent loops L’ and then tied or otherwise secured to create a continuous wire 302 interconnecting the loops L’. Theconnecting wire 302 may be secured, e.g., welded, to the loops L’ after the desired tightness is achieved. The tightness of the connecting wire 302 will dictate the attitude, or position, of the loops L’ relative to the central axis A. Because the loops L’ are secured together, it is now possible to provide the distal region with loops L’ in substantial parallel alignment with the central axis A, without concern that one of the loops L’ may become stuck in a side branch of the vasculature. Alternatively, the connecting wire 302 may be further tightened to cause the distal region and loops L’ to taper inward toward the central axis A.

[0067] Figure 17 illustrates another embodiment of a scaffold structure wherein distal loops L’ are secured to a marker band 402, allowing imaging visualization of the distal end of the scaffold structure’s position within vasculature, and preventing one of the loops L’ becoming caught in side branch vasculature. As shown, the marker band 402 comprises a size that causes or requires the distal region including the loops L’ of the expandable tubes or wires to bend inward toward a central axis A. Alternatively, the marker band 402 may be sized such that the distal region including the loops L’ remain substantially parallel with the central axis A.

[0068] The embodiments disclosed and described in Figs 14A-17 may comprise positioning the exemplary wire scaffold of self-expandable tubes or wires to be positioned at a point that is within the thrombus or clot, or may be positioned at a point that is at least partially distal with the thrombus or clot. In either case, at least a portion of the thrombus or clot may be retained within the exemplary wire scaffold as a consequence of the self-expansion of the tubes or wires into the thrombus or clot, and in combination with the distal tapered region which further aids in retaining thrombus or clot within the boundaries of the self-expandable wires.

[0069] One embodiment of the present disclosure may comprise:

[0070] A scaffold structure surrounding a portion of a tubular body and configured for thrombectomy and / or thrombolytic procedures within a blood vessel, comprising:

[0071] a self-expanding helical scaffold comprising:

[0072] a series of tubes or wires having proximal and distal ends, wherein the proximal ends and the distal ends arc operatively associated, or connected, with the tubular body,

[0073] wherein each tube or wire in the series of tubes or wires comprises a first length that extends in a distal direction, a second length that extends in a proximal direction, and a transitional section between the first length and the second length;

[0074] a distal slidable element comprising a wall and defining a lumen therethrough and configured to slidingly receive the tubular body therethrough.

[0075] Any one of the above-described embodiments may comprise tubes that may be formed of a shape memory material, e.g., nitinol, to allow a self-expanding scaffold structure. The self-expandable tubes of such a scaffold may include a plurality of ports along at least part of the tube length to allow a thrombolytic agent to flow from a lytic agent reservoir, through a lumen, or a plurality of lumens disposed along either the catheter body or the tubular body, through the ports and into a thrombus or blood clot.

[0076] The infused agent may further comprise other therapeutic agents in addition to, or in place of, a thrombolytic agent. For example, and without limitation, chemotherapy agents, liquid embolics, antirestenotic drugs, cardiovascular drugs, or other materials may be infused using the structures described herein.

[0077] In addition, the above-described embodiments may be employed as thrombectomy devices, as thrombolytic devices, or as a combination of thrombectomy and thrombolytic devices.

[0078] The embodiments described herein may be used in any blood vessel including but not limited to peripheral vessels, cardiac vessels, neural vessels and portomenenteric vessels, and may be deployed, e.g., to infuse drugs such as cardiovascular drugs directly into a patient’s lungs. In some embodiments, the described structures and methods may be used within systems such as, without limitation, the biliary system.

[0079] While the abov5e specification and examples provide a complete description of the structure and exemplary embodiments, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the inventions disclosed herein.

Claims

AMENDED CLAIMS received by the International Bureau on 15 September 2025 (15.09.2025)1. A scaffold device surrounding a portion of a tubular body having a central axis, and configured for thrombectomy and / or thrombolytic procedures within a blood vessel, comprising: a self-expanding helical scaffold comprising a plurality of individual tube structures surrounding a portion of the tubular body and configured to expand to an expanded configuration and to be compressed to a compressed configuration, each tube structure of the plurality of tube structures defining an inner lumen therethough and a plurality of ports in fluid communication with the inner lumen, the ports configured to allow fluid within the inner lumen to discharge through the plurality of ports, wherein the plurality of individual tube structures each comprise a distal tapered section when the self-expanding helical scaffold is in an expanded configuration and a flat section adjacent to, and distal of, the distal tapered section, wherein the plurality of individual tube structures are arranged helically around the tubular body, wherein the plurality of individual tube structures are configured into pairs of tube structures within the flat section; a distal slidable element comprising a continuous wall and surrounding the tubular body, the continuous wall defining a lumen therethrough configured to slide axially along the tubular body, wherein a distal end of the flat section of the pairs of the plurality of individual tube structures are operatively connected or associated with the distal slidable element, wherein the pairs of tube structures are spaced apart from each other around the tubular body.

2. (Canceled)3. The scaffold device of claim 1, wherein the plurality of individual tube structures comprises six individual tubes that are configured into three pairs of tube structures within the distal tapered section and flat section.

4. (Canceled)5. (Canceled)6. (Canceled)7. The scaffold device of claim 1, wherein a proximal end of each of each one of the plurality of individual tube structures is operatively connected or associated with the tubular body.

8. (Canceled)9. (Canceled)10. (Canceled)11. (Canceled)12. (Canceled)13. (Canceled)14. The scaffold device of claim 1, wherein the distal slidable element is configured to slide axially and distally along the tubular body in response to the self-expanding helical scaffold achieving a collapsed, compressed configuration within a lumen defined by a catheter body surrounding the tubular body.

15. The scaffold device of claim 14, wherein the distal slidable element is configured to slide axially and proximally along the tubular body in response to the self-expanding helical scaffold achieving an expanded configuration when the self-expanding helical scaffold is released from the lumen defined by the catheter body.

16. The scaffold device of claim 1, wherein the tubular body extends distally beyond the distal slidable element.

17. The scaffold device of claim 16, wherein an atraumatic tip is operatively connected or associated with a distal end region of the tubular body.

18. (Canceled)19. The scaffold device of claim 1, wherein each one of the pairs of tube structures within the tapered section are configured to taper inward toward the central axis of the tubular body when the selfexpanding helical scaffold achieves an expanded configuration.

20. The scaffold device of claim 1 , wherein the pairs of tube structures are equally spaced apart from each other around the tubular body.

21. The scaffold device of claim 1, wherein the pairs of tube structures are not equally spaced apart from each other around the tubular body.

22. (Canceled)23. (Canceled)24. (Canceled)25. (Canceled)25. (Canceled)26. (Canceled)27. (Canceled)28. (Canceled)29. (Canceled)30. (Canceled)31. (Canceled)32. The scaffold device of claim 1 , further comprising a screen associated with at least a portion of the self-expanding helical scaffold.

33. (Canceled)34. The scaffold device of claim 1 , wherein the screen covers an outer surface of at least a portion of the self-expanding helical scaffold.

35. The scaffold device of claim 1, wherein the screen covers an inner surface of at least a portion of the self-expanding helical scaffold.

36. The scaffold device of claim 1, wherein the screen is operatively associated with an atraumatic tip that is disposed at a distal end of the tubular body.

37. The scaffold device of claim 1 , wherein the screen is operatively associated with the distal slidable element.

38. (Canceled)39. A method for disrupting a thrombus or clot within a blood vessel, comprising: providing the scaffold device of claim 1 ; advancing the scaffold device within the blood vessel;expanding the self-expanding helical scaffold such that at least a portion of the expanded self-expanding helical scaffold extends into the thrombus or clot; discharging lytic fluid through the plurality of ports into the thrombus or clot; capturing at least a portion of the thrombus or clot within the self-expanding helical scaffold; collapsing the self-expanding helical scaffold; and removing the scaffold device from the blood vessel along with at least a portion of the captured thrombus or clot.

40. The method of claim 39, wherein the scaffold device is configured to perform mechanical thrombectomy and / or thrombolysis.

41. The scaffold device of claim 1, wherein the plurality of individual tube structures are configured into individual tube structures proximal of the distal tapered section.42 The scaffold device of claim 1 , wherein the plurality of individual tube structures are configured into individual tube structures proximal of the flat section.

Images