Guide Extension Catheter

Abstract

The guide extension catheter comprises a proximal reinforcement region that is completely surrounded or enclosed by a polymer that coats or covers the proximal reinforcement region, and further comprises an exemplary semi-circular flare-shaped region disposed proximal to the proximal reinforcement region, the flare being interrupted by a flat lower portion. The proximal reinforcement region is configured to interconnect with a flat ribbon that is connected to or defines a proximally extending push rod. The proximal reinforcement region does not extend beyond the most proximal end of the exemplary semi-circular flare-shaped region.

Description

Technical Field

[0001] Cross - References to Related Applications This application claims priority to U.S. Utility Application No. 17 / 809,668, filed on June 29, 2022, entitled "GUIDE EXTENSION CATHETERS", and Provisional Application No. 63 / 365,715, filed on June 2, 2022, entitled "HIGH PERFORMANCE MICROCATHETERS", the entire contents of which are hereby incorporated by reference into this specification.

[0002] Description of Research and Development Sponsored by Federal Government Funds Not applicable

[0003] Guide Extension Catheters for Use in Endovascular Medical Procedures

Background Art

[0004] Generally, an artery can become occluded or otherwise damaged as a result of, for example, loss of elasticity and / or compliance due to the accumulation of calcified material along the lumen of the artery and / or reaching within the arterial wall. Percutaneous interventions and treatments can be achieved using known intervention tools and known techniques, including, without limitation, angioplasty, atherectomy, lithotripsy, and / or thrombectomy, and procedures associated with delivering a stent across a chronic total occlusion. A guide catheter can be used to assist in treating a coronary artery or a peripheral artery. In some cases, percutaneous access can be achieved at the patient's femoral artery and in other cases at the patient's radial artery (transradially). Facilitating the delivery of intervention and / or diagnostic tools is a common use of a guide catheter. Once positioned within the vasculature, a guide catheter can be used to facilitate smoother advancement of an intervention tool and / or a percutaneous catheter through a tortuous vasculature by reducing the radial deflection, buckling, and / or kinking of the intervention tool and / or the percutaneous catheter. In addition to the complex percutaneous intervention problems described above that require additional support for a guide catheter, transradial procedures can also require additional support. A guide extension can be used in either case to provide the required support.

[0005] Generally used guide extension systems are available in 5F, 5.5F, 6F, 7F, and 8F, including the Guideliner® catheter from Teleflex, the Guidezilla® and Guidezilla II® from Boston Scientific Corp, the Telescope® from Medtronic, the Boosting Catheter from QXMedical, and the Guidion® from Interventional Medical Device Solutions.

[0006] Generally, these known systems include a proximal portion, or rapid exchange zone, that is partially open, i.e., not completely closed. For example, Guideliner® and Guidion® each include a half-tube portion at the proximal end of the otherwise completely closed distal portion, and Guidezilla® includes a tapered or cut-open portion at the proximal end of the otherwise completely closed distal portion. Telescope® includes an open tapered or cut proximal portion that leads to an open half-tube proximal extension. The QXMedical Boosting Catheter also includes a fully circumferentially flared cut or tapered proximal portion that leads to an open half-tube portion.

[0007] To further illustrate some of these known designs, FIG. 1 shows a commercially available guide extension catheter device 10 sold as Guidezilla®, which is illustrated with the polymeric coating removed, and includes a braided flexible tube 12, a cut or tapered proximal region 14 that is directly connected to a pushrod or rail 16 at a lower portion 15 of the cut or tapered proximal region 14, and further includes a proximal handle (not shown) that is connected to the pushrod or rail 16 to enable an operator to translate and / or rotate the guide extension catheter.

[0008] FIG. 2 illustrates a commercially available guide extension catheter device 20 sold as Guideliner®, which includes an overcoated braided flexible tube 22, a cut or tapered portion 24, and a side view of a half-tube portion 26, and a pushrod 28 connected to a lower portion 27 of the half-tube portion 26, and further includes a proximal handle (not shown) that is connected to the pushrod 28 to enable an operator to translate and / or rotate the guide extension catheter.

[0009] Note that the prior art device of FIG. 1 does not include the split tube region of the device shown in FIG. 2. Further, the known device of FIG. 1 provides an open, i.e., unenclosed by a polymer coating or jacket, cut or tapered proximal region. Similarly, the known device of FIG. 2 provides the cut or tapered portion and the split tube portion as open, i.e., unenclosed by a polymer coating or jacket. However, both devices shown in FIGS. 1 and 2 include a polymer overcoating or jacket around the braided flexible tube portion.

[0010] It is desired to provide a guide extension catheter with various features of the tube, such as steerability, variable bend flexibility along the working length, pushability, and / or improved control of crush resistance or torsional resistance.

[0011] Furthermore, the open cut / taper and / or split tube designs of known commercial systems may not form a seal between the fully enclosed portion of the guide extension catheter and the surrounding guide catheter. Additionally, known guide extension systems include a proximal portion, or rapid exchange region, an opening that interfaces with or connects to a curved split tube region for loading and / or exchanging a catheter or intervention tool, and the like. This can result in difficulty inserting the catheter and / or tool into the lumen of the distal fully enclosed portion. Additionally, the braided flexible tube provides the framework for the desired characteristics of the guide extension system. If the tube is too flexible, positioning of the guide extension system within the anatomical structure becomes difficult due to low pushability, which can cause the guide extension system to be placed more proximally than desired. SUMMARY OF THE INVENTION

[0012] The various inventions disclosed herein address these problems, among others.

[0013] These drawings are illustrative examples of specific embodiments and, as such, are not intended to limit the present disclosure.

Brief Description of the Drawings

[0014]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Modes for Carrying Out the Invention

[0015] Referring to the figures, Figure 3 illustrates one embodiment of the guide extension catheter 100 of the present invention. The guide extension catheter 100 thus includes a flexible tube region 102 shown as being coated with a material such as, for example and without limitation, a polymer such as PTFE or the like. The flexibility of the flexible tube region 102 can vary in the distal or proximal direction, or can change, e.g., increase, or can be constant along the length of the flexible tube region. A flexible tip 103 is disposed at the distal end of the flexible tube region 102, and a radiopaque marker 104 can be disposed at and / or near the distal end and / or proximal end of the flexible tube region 102. As shown, the distal radiopaque marker 104 is just proximal to the tip 103. Another radiopaque marker 106 can be provided at or near the proximal end of the flexible tube region 102. Both the distal and proximal radiopaque markers 104, 106 are shown as "bands", but other marker configurations such as radiopaque deposits or coatings are also contemplated and are within the scope of the present invention.

[0016] At least a portion of the flexible tube region 102 can be formed or reinforced by a structure that provides a tubular shape as well as the desired flexibility and other operating characteristics. For example, laser cut hypotubes, braids, and / or reverse wound coils can be used with an outer polymeric coating, coating, or jacket as described above.

[0017] In some embodiments of the present invention, the flexible reinforced tube region 102 and / or the proximal portion, which may not be reinforced, can transition to a proximally located semi-circular region that can include a tapered partial conical or flare, or can include a partial cylinder, and the semi-circular shape of the proximally located semi-circular region is interrupted by a flat lower region further discussed below.

[0018] In other embodiments, the flexible reinforcement tube region 102 can transition to a proximally located, fully tapered partial cone or flare, or a full cylinder, and the semi-circular shape of the proximally located semi-circular region is not interrupted by the flat lower region further discussed below. In some embodiments, the flat lower region can include components manufactured flat, without the need for the components to initially be non-flat and then flattened.

[0019] In the illustrated embodiment of FIG. 3, the flexible reinforcement tube region 102 transitions in the proximal end region to a semi-circular region that includes a partially or interrupted flare-shaped or partial conical-shaped region 108, and the inner and outer diameters of the partially flared region 108 are tapered and increase in the proximal direction, and the inner and outer diameters of the flexible reinforcement tube region 102 are smaller than the inner and outer diameters at any point along the partially flared region 108. As shown in FIG. 3, the partially flared region 108 is an interrupted, or incomplete, or asymmetric flare or cone that includes a flat lower surface 110, and as a result, the partially flared region 108, which includes a semi-circular structure having a straight or flat lower surface 110 in any longitudinal cross-section of the partially flared region 108, and thus is not a complete flare or conical-shaped structure. The partially flared region 108 terminates at the proximal end at an angle substantially perpendicular to the central longitudinal axis A without tapering or cutting.

[0020] The flat lower surface 110 is shaped to be complementary to the flat ribbon region 112 disposed at least partially along and thus within the extent or area surrounded by the flat lower surface 108 of the partially flared region 108, and in some embodiments, it can extend distally a distance into and along the flexible tube region 102 that extends proximally to the partially flared region 108.

[0021] The flat ribbon region 112 can be operably connected to a proximal portion or a proximally extending portion of the tube region 102 and can be, for example, welded or soldered or snap - fastened. As shown, the flat ribbon region 112 can be configured to extend along the flat lower surface 110 and slightly into the inner diameter ID of the partial flare region 108. In other embodiments, the flat ribbon region 112 can occupy space within the polymer such that it does not affect the inner diameter ID of at least the partial flare region 108. The flat ribbon region 112 can be operably connected to a proximal portion or a proximally extending portion of the flexible tube region 102 and can be, for example, welded or soldered or snap - fastened. Similarly, in embodiments including a flat ribbon region 112 that extends distally into the flexible tube region 102 past the partial flare region 108, the flat ribbon region 102 can reduce the nominal ID of the flexible tube. The dashed line in FIG. 4A that extends distally the length of the flat ribbon region 112 to operably connect to an exemplary laser - cut tube illustrates one such embodiment.

[0022] In other embodiments, the flat ribbon region 112 can be disposed within the wall W of the partial flare region 108, can be, for example, contained by the polymer of the partial flare region 108, and in some embodiments as discussed above, can be disposed within the wall W' of the flexible tube region 102, but that is so that it does not reduce the nominal inner diameter ID of the partial flare region 108 or, here too in some embodiments, the nominal inner diameter of the flexible tube region 102. As seen in FIGS. 4A and 4B, the flat ribbon region 112 can be positioned at the distal end of a push rod 114 that can include a handle 116 disposed at the proximal end of the push rod 114. The operator can manipulate the handle 116 that is outside the patient during an intravascular procedure to translate and / or rotate the guide extension device 100 and, in particular, the position of the device 100 within the patient's vasculature.

[0023] Figures 4A and 4B illustrate one embodiment of the flexible reinforcement tube region 102 formed by the helical laser cut tube 118. As shown and continuing to refer to FIG. 3, the pitch (or the distance along the length of the flexible reinforcement tube region 102 corresponding to the center longitudinal axis of the lumen (not shown but defined through the tube region 102 and the partial flare region 108), or the distance between the cuts in the longitudinal direction) P is constant along the length of the flexible reinforcement tube region 102, such as the angle α of the spiral cut with respect to the line perpendicular to axis A as shown in FIG. 4B.

[0024] The helical laser cut tube 110 forming the flexible reinforcement tube region 102 of FIGS. 4A and 4B is shown including a distal marker band 104 and a proximal marker band 106 with a portion 120 extending proximally of the flexible tube. The semi-circular region shown as the partial flare 108 is illustrated as not including a laser cut tube or hypotube structure. In other words, one embodiment may include a proximal portion including the proximal portion 120 of the flexible tube 102 and a more proximal partial flare region 108, both of which are formed from a polymer, such as PTFE, or a related material, and are operatively connected to the laser cut tube 118 and / or the intervening radiopaque markers 106 as shown. The reinforcement structure, such as the laser cut tube 110, does not extend proximally into the proximal portion 120 and / or the proximal partial flare region 108. In other embodiments, the helical laser cut tube 118 may extend through the proximal and / or distal radiopaque markers 104, 106, and / or the region including the more proximal flexible tube region 120, and / or at least a portion of the partial flare region 108, to provide shaping and / or flexibility or other support for the proximal region 120 and / or the partial flare region 108 of the flexible tube region 102.

[0025] FIG. 5 illustrates an exemplary guide extension catheter 100 that includes a flexible tube region 102 formed by the helical laser cut tube 118' of FIGS. 4A and 4B, and the pitch or longitudinal distance between cuts, shown as P1 being less than the length P2, increases as it moves from the distal end to the proximal end of the helical laser cut tube 118' to modify the flexibility profile along the length of the helical laser cut tube 118' and the flexible tube region 102. Another embodiment may include increasing or decreasing the angle α of the cuts along the helical laser cut tube shown in FIG. 4B with respect to the central axis A.

[0026] FIG. 6 illustrates a BRAID embodiment of the guide extension catheter 100, which is similar to that of FIGS. 4A and 4B, but in which a braided structure 122 is provided instead of the helical laser cut tube forming the flexible tube region 102. As is known in the art, the braid pitch and / or pic number may be selected to be constant along the length of the flexible tube, or modified to adjust or affect the longitudinal flexibility of the flexible tube and other features described thereon.

[0027] Furthermore, at least one portion of the flexible tube region 102 may include a helical laser cut tube 118 and / or 118' as described above in connection with FIGS. 4A, 4B, and 5, but at least one other portion of the flexible tube region 102 may include a braided structure 122 to adjust and fine-tune the operating characteristics of the flexible tube region 102.

[0028] Figure 7 is also similar to those of FIGS. 4A and 4B, but instead of the helical laser cut tubes 118, 118' and / or the braided cords 122 as described above, the flexible tube region 102 can consist of two reverse wound coils 124, 125, illustrating a guide extension catheter 100COIL embodiment, where the upper coil 125 can be wound over the lower coil 124. Those skilled in the art will recognize that two or more, for example three, reverse wound coils can be used in this manner. For example, a first lower coil can be wound over the liner tube 126, a second intermediate coil can be wound in the opposite direction over the first lower coil, and a third upper coil can be wound in the opposite direction to the winding direction of the second intermediate coil. The coil winding pitch (the longitudinal distance between the wires within the coil) and / or the angle α of the coil winding with respect to a line perpendicular to the central axis A can be selected to be constant along the length of the flexible tube region 102, or modified to adjust or affect the longitudinal flexibility of the flexible tube region 102 and other features described above for the flexible tube region 102. The winding pitch of any given coil at any point along the length of the wound coil, e.g., 124, 125, can be zero or greater than zero and can vary along the longitudinal length of the wound coil. Thus, the flexibility can be modified, e.g., increased, distally along the length of the flexible tube region 102.

[0029] Furthermore, at least one portion of the flexible tube region 102 can include the helical laser cut tubes 118 and / or 118' as described above in connection with FIGS. 4A, 4B, and 5, but at least one other portion of the flexible tube region 102 can include two or more reverse wound coils, e.g., 124, 125, and / or at least one other portion of the flexible tube can include the braided cord 120 to adjust the operating characteristics of the flexible tube region 102.

[0030] Moving on to FIG. 8, an alternative and preferred, reinforced guide extension catheter 100 embodiment is provided, which is similar to that described above in connection with FIGS. 4A-7, but includes a proximal reinforcement region 200 (shown in dashed lines) disposed within or completely surrounded by at least a portion of the proximal flexible tube region 20 and the partial flare region 108. The proximal reinforcement region 200 includes a distal region 202 that is cut or tapered downwardly in the proximal direction, which transitions to a central non-tapered region 203, which tapers proximally downwardly in the proximal direction to form a flat lower connector region 204 via a tapered region 206. The central non-tapered region 203 forms a longitudinally semi-circular shape with an open upper region, as best observed in the embodiments illustrated in FIGS. 9A-9D. The flat lower connector region 204 includes a notch or cutout 206 that is complementary in shape to the distal end of the flat ribbon region 112 discussed above, such that the flat ribbon region 112 can be operably interconnected with the notch or cutout 206 by various means well known to those skilled in the art, including, without limitation, welding, soldering, and snap fitting.

[0031] FIG. 8A illustrates one embodiment of the proximal reinforcement region 200, showing a distal region 202 that is cut or tapered downwardly in the proximal direction to transition to a central non-tapered region 203, which includes an open semi-circular shape along its longitudinal length. At the proximal end, the proximal reinforcement region 200 includes a lower connector region 204' that may include a curved shape to conform to the curvature of the surrounding polymer wall W. The lower connector region 204' may include a notch or cutout 206, as shown.

[0032] In all embodiments including the proximal reinforcement region 200, the interconnection between the flat ribbon region 112 and the notch or cut 206 is shown as including two flat interconnect structures 112 and 204 such that the flat ribbon region 112 fits within the notch or cut 206 and is secured by known means such as welding, soldering, and / or snap fitting. However, as shown in FIG. 8A, the flat ribbon region 112 may be modified in some embodiments to conform to or complement the curved shape of the wall of the elongate flexible tube and / or the central non-tapered region 203. In this embodiment, the notch or cut 206 and the connector regions may all include complementary curvatures to the curved ribbon region to facilitate a secure and operative engagement therebetween.

[0033] In some embodiments, the proximal reinforcement region 200 may be formed from the helically laser cut tubes 118 and / or 118' of FIGS. 4A and 4B. In other embodiments, the proximal reinforcement region 200 may be manufactured separately and then operatively connected to the flexible tube region 102 and the flat ribbon region 112. Accordingly, the proximal reinforcement region 200 may be used in connection with any of the embodiments of the flexible tube region 102 discussed above.

[0034] The proximal reinforcement region 200, as discussed, may preferably be surrounded by or disposed within a polymeric coating or jacket, such as PTFE, or other material, and thus does not extend distally and outwardly beyond the proximal end of the partial flare region 108. In other words, portions of the flexible tube 102, such as the proximal portion 120 of the flexible tube region 102 and the partial flare region 108, completely encompass and surround the proximal reinforcement region 200. In some embodiments, the proximal reinforcement region 200 may be embedded within a polymeric material that defines, surrounds, and / or reinforces the proximal portion 120 of the flexible tube region 102 and the partial flare region 108.

[0035] Alternatively, in some embodiments, the proximal reinforcement region 200 may be present as described above, but the resulting device includes a partial cylinder 210 instead of the partial flare region 108, and the partial cylinder 200 does not taper outwardly at its proximal end and is complementary in shape to the flat ribbon region 112, similar to the flat lower surface 110 of the partial flare region 108, and does not include a flat lower surface 110' configured for the interconnection of the flat ribbon region 112 and the cut or notch 206.

[0036] Figures 9A - 9D illustrate a proximal reinforcement region 200R for the proximal portion 120 of the flexible tube region 102, and one of the following semi - circular regions: the partial flare region 108, and the partial cylinder region 210, or one of the following complete semi - circular regions: the complete flare region 108', and the complete cylinder region 210'. In each embodiment, the proximal reinforcement region 200R does not extend proximally beyond the proximal end of the illustrated partial or complete semi - circular region, or the partial or complete cylinder region.

[0037] Therefore, FIGS. 9A-9D illustrate alternative embodiments of the proximal reinforcement region 200R as described above, and further include a partial or semi-circular support ring 212 disposed at or near the distal end of the flat lower connector region 204, or a curved lower connector 204' (as shown), all of which remain completely surrounded by a portion of the flexible tube region 102 and / or the partial flare region 108, the full flare region 108', the partial cylindrical region 210, and / or the full cylindrical region 210'. The partial or semi-circular support ring 212 can be embedded within the proximal portion 120 of the flexible tube portion 102 and / or the flare (partial and / or full) and / or cylinder (partial and / or full) material. The ring 212 extends circumferentially away from the flat lower connector region 204 and / or the notch or cutout 206 on both sides of the notch or cutout of the proximal reinforcement region 200R to define an interrupted, or partial, or semi-circular ring 212 while maintaining the connectivity of the cutout and the flat ribbon. The partial ring 212 can be semi-circular in shape to conform to the radius or curvature of the polymer wall W, and in some embodiments, can include an upper surface parallel to the central axis A, and in other embodiments, can taper upwardly and outwardly in the distal direction to conform to the taper of the partial flare region 108 when present.

[0038] FIG. 9A shows the proximal reinforcement region 200R with the partial or semi-circular support ring 212 attached thereto and the full flare region 108', i.e., without the flat lower portion 110. Alternatively, FIG. 9B provides the same proximal reinforcement region 200R with the partial or semi-circular support ring 212 and the partial flare region 108 as described in connection with FIGS. 4A and 4B.

[0039] FIG. 9C illustrates the proximal reinforcement region 200R with the partial or semi-circular support ring 212 attached thereto, and instead of the flare region (either full or partial), a full cylindrical region 210' is provided, i.e., without the flat lower portion 110.

[0040] FIG. 9D illustrates the proximal reinforcement region 200R with the portion or semi-circular support ring 212 attached thereto, and the partial cylinder 200R at the distal end of the flexible tube 200 has a flat lower region 110 to accommodate the flat ribbon 112 interconnect with the defined notch or cut 206 of the proximal reinforcement region 200R.

[0041] In all cases, the support ring 212 does not extend distally beyond the proximal end of the semi-circular (partial or complete) region and is thus completely surrounded by or enclosed within the proximal portion 120 of the flexible tube region 102 and / or the polymer wall W of the semi-circular region.

[0042] FIG. 10A is similar to that of FIGS. 8 - 8A and further illustrates an alternative proximal reinforcement region 200B that includes an upper support beam 214 extending proximally away from the distal taper region 202 along the flexible tube and the upper side of the flexible tube opposite the lower flexible tube including the notch or cut 206 of the proximal reinforcement region 200B. The distal portion of the upper support beam 214 runs parallel to the central axis A along the proximal portion 120 of the flexible tube region and in some embodiments, in some flared (partial or complete) embodiments, includes an additional distal portion 215 that tapers outwardly in the distal direction to match the outward taper of the flare as shown and can extend proximally along the semi-circular region. FIG. 10A illustrates a completely flared region 108' at the proximal end, i.e., there is no flat lower region. All elements of the proximal reinforcement region 200B including the upper support beam are surrounded by or embedded within the flexible tube and / or the complete flare and do not extend proximally beyond the proximal end of the flared region 108'.

[0043] Figure 10B illustrates an alternative proximal reinforcement region 200B for the embodiment of Figure 10A that includes an upper support beam 214 and a partial flare region 108 as in Figures 4A and 4B, and thus includes a flat lower region 110 for accommodating the flat ribbon 112 and the interconnectivity of the flat ribbon 112 and the defined notch 206 of the proximal reinforcement region 200 as described above. All elements of the proximal reinforcement region 200B including the upper support beam are surrounded by or embedded within the flexible tube and / or the partial flare region 108 and do not extend proximally beyond the most proximal end of the partial flare region 108.

[0044] Figure 10C is a further alternative proximal reinforcement region 200B that includes an upper support beam 214, where the full flare 108' of Figure 10A is replaced with a full cylinder 210', and no portion of the proximal reinforcement region 200B including the upper support beam extends proximally beyond the most proximal end of the full cylinder 210'.

[0045] Figure 10D illustrates an alternative proximal reinforcement region 200B that includes an upper support beam 214 and includes a partial cylinder 210 with a flat lower region 110 configured to accommodate its engagement with the flat ribbon 112 and the notch 206 of the proximal reinforcement region 200B. As with other embodiments, no portion of the proximal reinforcement region 200B, including the upper support beam 214, extends proximally beyond the most proximal end of the partial full cylinder 210.

[0046] Figure 11A is similar to the embodiment of FIG. 9A, and the proximal reinforcement region 200E includes an expansion member 216 that includes an expandable portion 217 disposed along the periphery of the support ring 212 at or near the distal end of the proximal reinforcement region 200. The expandable portion 217 includes a structure that elongates under sufficient force. For example, and without limitation, springs, shock absorbers, coils may be implemented. FIGS. 11A-11D illustrate an exemplary z-shaped expandable portion 217. Thus, the expansion member 216 is configured to change the outer periphery such that when the exemplary z-shaped expandable portion 217 is forced to expand when an outwardly radially directed force is applied thereto, the "z" shape becomes more linear and elongates as seen during translation of the intervention device. In some embodiments, an inwardly directed radial force may be required to contract or collapse the expanded configuration back to the non-expanded configuration, or alternatively, the expandable portion 217 may be biased to return to the non-expanded configuration. Thus, the z-shaped expandable member embodiment 217 can move towards a more linear form as it expands or compresses, or collapses radially when subjected to an expansion or compression force that exceeds a base threshold force. In a preferred embodiment, the expandable portion 217 can be formed of a shape memory material such as nitinol or the like having an undeformed rest configuration and a deformed expanded configuration. Alternatively, the expandable portion 217 can be biased to an undeformed rest configuration, but can be expanded when at least a partially outwardly radially directed force that overcomes the biasing force is applied. The expansion member 216 having the expandable portion 217 thus provides a way to more easily translate the intervention device into and through the lumen of the flexible tube 102. The expansion member 216 and the expandable member 217 can be surrounded by and / or embedded in the flexible tube and do not extend proximally beyond the proximal end of the full flare region 108' of FIG. 11A.

[0047] Figure 11B includes an alternative embodiment of the proximal reinforcement region 200E of FIG. 11A, where the full flare region 108' of FIG. 11A is replaced with a partial flare region 108 and a flat lower region 110 is provided.

[0048] Figure 11C provides another embodiment of the proximal reinforcement region 200E that is similar to that of Figure 11A, but where the full flare region 108' of Figure 11A is replaced with a full cylinder 210'.

[0049] Figure 11D provides another embodiment of the proximal reinforcement region 200E that is similar to that of Figure 11C, but here includes a partial cylinder 210 having a flat lower surface 110'.

[0050] The description of the invention and its application as set forth herein are illustrative and are not intended to limit the scope of the invention. The features of the various embodiments can be combined with other embodiments within the intended scope of the invention. Variations and modifications of the embodiments disclosed herein are possible, and practical alternatives to the various elements of the embodiments and equivalents of the various elements of the embodiments will be understood by those skilled in the art from the study of this patent document. These and other variations and modifications of the embodiments disclosed herein can be made without departing from the scope and spirit of the invention.

Description of Reference Numerals

[0051] 100 Guide extension catheter 102 Flexible tube region 103 Flexible tip 104 Distal radiopaque marker / distal marker band 106 Distal radiopaque marker / proximal marker band 108 Partial conical shape region 108 Partially flared region 110 Flat lower surface 112 Flat ribbon region 114 Push rod 116 Handle 118 Helically laser cut tube 118’ Helically laser cut tube 120 Proximal portion 122 Braided structure 124 Coil / wire coil, lower coil 125 wound coil / reverse wound coil, upper coil 126 liner tube 200 proximal reinforcement region 202 distal region 203 central non-tapered region 204 flat lower connector region 204’ lower connector region 206 tapered region 206 notch or incision 204 flat interconnect structure 210 partial cylindrical region 210’ full cylindrical region 212 semi-circular support ring 214 upper support beam 215 additional distal portion 216 extension member 217 expandable portion

Claims

1. A flexible tube region, A flexible reinforcement portion including one or more of the group consisting of a laser cut tube, a braided cord, and at least two reverse wound coils, A proximal reinforcement region disposed proximal to the flexible reinforcement portion, and A semi-circular region disposed proximal to the proximal reinforcement region and including a flat lower region having, a flexible tube region; A flat ribbon region connected to the proximal portion of the proximal reinforcement region portion and extending proximally along the flat lower region of the semi-circular region; A push rod operably connected to the proximal portion of the flat ribbon region and including a proximal handle, the push rod comprising, The flexible tube region is coated with a polymer defining a wall, The proximal reinforcement region is a guide extension catheter that does not extend proximally beyond the proximal end of the semi-circular region.

2. The guide extension catheter according to claim 1, wherein the proximal reinforcement region is disposed within the wall of the flexible tube region.

3. The guide extension catheter according to claim 1, wherein the proximal reinforcement region includes a flat or curved lower connector region, and the flat ribbon region is connected to the flat or curved lower connector region.

4. The proximal reinforcement region, A tapered distal region that tapers downward in the proximal direction, and A central non-tapered region having a longitudinally open semi-circular shape further comprising, The proximal end of the flat or curved lower connector region defines a notch that is complementary in shape to the shape of the distal end of the flat ribbon region such that the flat ribbon region is operably connected within the notch and thus connected to the proximal reinforcement region, the guide extension catheter according to claim 3.

5. The guide extension catheter according to claim 4, wherein the connected flat ribbon region does not reduce the inner diameter of the flexible tube region.

6. The guide extension catheter according to claim 4, wherein the connected flat ribbon region reduces the inner diameter of the flexible tube region.

7. The guide extension catheter according to claim 1, wherein the semi-circular region includes a frustum-shaped flare shape.

8. The guide extension catheter according to claim 1, wherein the semi-circular region includes a partial cylindrical shape.

9. The laser cut tube includes a helical cut, the flexible tube region includes a central longitudinal axis, The helical cut includes a pitch and an angle with respect to the central axis, The guide extension catheter according to claim 1, wherein the pitch and the angle are constant even when moving from the distal end to the proximal end along the laser cut tube.

10. The laser cut tube includes a helical cut, and the flexible tube region includes a central longitudinal axis, The helical cut includes a pitch and an angle with respect to the central axis, The guide extension catheter according to claim 1, wherein the pitch and the angle are not constant when moving from the distal end to the proximal end along the laser cut tube.

11. The guide extension catheter according to claim 10, wherein the pitch of the helical cut becomes longer when moving from the distal end to the proximal end along the laser cut tube.

12. A flexible tube region, A highly flexible reinforcing portion including one or more of a laser cut tube, a braided string, and at least two reverse wound coils, A proximal reinforcing region disposed proximal to the highly flexible reinforcing portion, A distal cutting region that tapers downward in the proximal direction, A central non-tapered region having a longitudinally open semi-circular shape, A flat or curved lower connector region having a proximal end defining a notch, and A semi-circular support ring connected to the flat or curved lower connector region Including a proximal reinforcing region, A flexible tube region disposed proximal to the proximal reinforcing region and having a semi-circular region including a flat lower region, A flat ribbon region extending along the flat lower region of the semi-circular region and operably connected within the notch defined by the flat or curved lower region, a flat ribbon region Having a flexible tube region, A push rod operably connected to the proximal portion of the flat ribbon region and including a proximal handle, a push rod Comprising, The flexible tube region is coated with a polymer defining a wall, The guide extension catheter, wherein the proximal reinforcing region does not extend proximally beyond the proximal end of the semi-circular region.

13. The guide extension catheter according to claim 12, wherein the proximal semi-circular region includes a flare shape of a partial conical shape.

14. The guide extension catheter according to claim 12, wherein the proximal semi-circular region includes a partial cylindrical shape.

15. The semi-circular support ring includes an extension member and further includes an expandable portion, the expandable portion being configured to achieve an undeformed non-expanded configuration and also to expand to a larger deformed configuration when subjected to a radially outward force, the guide extension catheter according to claim 12.

16. The expandable portion is biased to maintain an undeformed configuration, the guide extension catheter according to claim 15.

17. The expandable portion includes a shape memory material, the guide extension catheter according to claim 15.

18. The extension member includes a z-shape in an undeformed configuration, the guide extension catheter according to claim 15.

19. A flexible tube region, A flexible strengthening portion including one or more of the group consisting of a laser-cut tube, a braided string, and at least two reverse-wound coils, A proximal strengthening region disposed proximal to the proximal flexible tube portion, and A full conical flare-shaped region disposed proximal to the proximal strengthening region and including a longitudinally cross-sectional shape that is completely circular, the full conical flare-shaped region having, a flexible tube region; A flat ribbon region connected to the proximal portion of the flexible strengthening portion of the flexible tube region; A push rod operably connected to the proximal portion of the flat ribbon region and including a proximal handle, the push rod comprising, The flexible tube region is coated with a polymer defining a wall, The proximal strengthening region does not extend proximally beyond the proximal end of the full conical flare-shaped region, the guide extension catheter.

20. A flexible tube region, A flexible strengthening portion including one or more of the group consisting of a laser-cut tube, a braided string, and at least two reverse-wound coils, A proximal flexible tube portion disposed proximal to the laser-cut tube, A proximal strengthening region disposed proximal to the proximal flexible tube portion, and A full cylindrical region disposed proximal to the proximal strengthening region and not including a flat lower region having, a flexible tube region; A flat ribbon region connected to the proximal portion of the flexible strengthening portion of the flexible tube region; A push rod operably connected to the proximal portion of the flat ribbon region and including a proximal handle, the push rod comprising, A guide extension catheter in which the flexible tube region is coated with a polymer that defines a wall and the proximal reinforcement region does not extend proximally beyond the proximal end of the fully cylindrical region.

Images