Guide extension catheter

Abstract

A guide extension catheter includes a proximal reinforcement section entirely surrounded by or encapsulated within, or coating, a polymeric cover, and further includes an exemplary semi-circular flared section disposed proximal to the proximal reinforcement section, the flaring is interrupted by a flat bottom. The proximal reinforcement section is configured to interconnect with a flat band that is connected with or defines a proximally extending pushrod. The proximal reinforcement section extends not beyond the proximal end of the exemplary semicircular flaring section.

Description

[0001] Inventor

[0002] B.H. Asmus, Minnetonka, Minnesota, United States citizen

[0003] J.A. McBroom, Champlin, Minnesota, United States citizen

[0004] J. W. Connelly, Minneapolis, Minnesota, United States citizen

[0005] C. Stowell, Watertown, Minnesota, United States citizen

[0006] C.J. Goetz, Maple Grove, Minnesota, United States citizen

[0007] D.J. Freeman, Otsego, Minnesota, United States citizen

[0008] K.M. Rauscher, Lake Leno, Minnesota, United States citizen

[0009] CROSS-REFERENCE TO RELATED APPLICATIONS

[0010] This application claims priority to U.S. non-provisional application No. 17 / 809,668, filed on June 29, 2022, entitled “Guide Extension Catheter,” and U.S. Provisional Application No. 63 / 365,715, filed on June 2, 2022, entitled “High Performance Microcatheter,” the entire contents of both applications being incorporated herein by reference. Technical Field

[0011] A guide extension catheter for use during endovascular medical procedures. Background Art

[0012] Related technical description

[0013] Usually, artery may become occluded or otherwise impaired due to the loss of elasticity and / or compliance caused by the accumulation of calcified materials along the lumen of the artery and / or the arterial wall.Percutaneous intervention and treatment can be realized using known technology using known intervention tools, known technology such as but not limited to angioplasty, atherectomy, lithotripsy and / or thrombectomy, and the operation related to crossing chronic total occlusion and delivery stent.Guide catheter can be used for adjuvant treatment of coronary artery or peripheral artery.In some cases, percutaneous access can be realized at the femoral artery of the patient, and in other cases at the radial artery of the patient (via radial artery) to realize.It is the common use of guide catheter to facilitate the delivery of intervention tool and / or diagnostic tool.Once positioned in the vascular system, guide catheter can be used to facilitate the smoother advancement of intervention tool and / or percutaneous catheter by alleviating the radial deflection, buckling and / or kink of intervention tool and / or percutaneous catheter through tortuous vascular system.Except for the above-mentioned complicated percutaneous intervention problem (needing to carry out additional support to guide catheter), radial artery surgery may also need additional support. In each case, a guide extension may be used to provide the required support.

[0014] Commonly used guided extension systems include 5F, 5.5F, 6F, 7F and 8F rules, including those from Teleflex. Catheter, from Boston Scientific Corp. and Guidezilla From Medtronic Enhanced catheters from QX Medical and Interventional Medical Device Solutions

[0015] Typically, these known systems include a proximal portion or quick-change section that is partially open, ie, not completely closed. For example, and Each includes a half-tube portion at the proximal end of an otherwise completely closed distal portion, and Included is a tapered or skived opening portion at the proximal end of an otherwise completely closed distal portion. The QX Medical enhanced catheter also includes a fully circumferentially flared truncated or tapered proximal portion that leads to an open half-tube portion.

[0016] To further illustrate some of these known designs, FIG. 1 shows a A commercially available guide extension catheter device 10 is illustrated in which the polymer coating is removed and includes a braided flexible tube 12, a cut or tapered proximal section 14, which is directly connected to a push rod or rail 16 at its lower portion 15, and the guide extension catheter device 10 further includes a proximal handle (not shown) connected to the push rod or rail 16 to enable an operator to translate and / or rotate the push rod or rail 16.

[0017] FIG2 shows an example of A commercially available guide extension catheter device 20 is sold, which includes a coated braided flexible tube 22, a cut or tapered portion 24 and a side view of a half-tube portion 26, and a push rod 28 connected to a lower portion 27 of the half-tube portion 26, and further includes a proximal handle (not shown) connected to the push rod 28 to enable an operator to translate and / or rotate the guide extension catheter.

[0018] Note that the prior art device of FIG. 1 does not include the half-tube portion of the device shown in FIG. 2. Further, the known device of FIG. 1 provides a truncated or tapered proximal section that is open, i.e., not surrounded by a polymer coating or sheath. Similarly, the known device of FIG. 2 provides the truncated or tapered portion and the half-tube portion as open, i.e., not surrounded by a polymer coating or sheath. However, both devices shown in FIG. 1 and FIG. 2 include a polymer outer coating or sheath surrounding the braided flexible tube portion.

[0019] It would be desirable to provide a guide extension catheter that has improved control over various properties of the tube (eg, steerability, variable bending flexibility along the working length, pushability, and / or resistance to collapse or kinking).

[0020] Further, the opening cut / tapered and / or half-tube design of known commercial systems may not form a seal between the fully enclosed portion of the guide extension catheter and the surrounding guide catheter. In addition, known guide extension systems include a proximal portion or a quick-change section, the opening of which is adjacent or connected to the curved half-tube portion for loading and / or replacing catheters or interventional tools, etc. This may make it difficult to insert catheters and / or tools into the lumen of the distal fully enclosed portion. In addition, the braided flexible tube provides support for the desired characteristics of the guide extension system. If the tube is too flexible, the positioning of the guide extension system within the anatomical structure may become difficult due to low pushability and cause the guide extension system to be placed more proximally than desired.

[0021] The various inventions disclosed herein address, among other things, these problems. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] These drawings are exemplary illustrations of certain embodiments and therefore are not intended to limit the present disclosure.

[0023] FIG. 1 shows a known guide extension catheter.

[0024] FIG. 2 shows another known guide extension catheter.

[0025] Figure 3 A side view of one embodiment of the present invention is shown.

[0026] Figure 4A A side, partially cut-away view of one embodiment of the present invention is shown.

[0027] Figure 4B A top partial cross-sectional view of one embodiment of the present invention is shown.

[0028] Figure 5 A side, partially cut-away view of one embodiment of the present invention is shown.

[0029] Figure 6 A side, partially cut-away view of one embodiment of the present invention is shown.

[0030] Figure 7 A side, partially cut-away view of one embodiment of the present invention is shown.

[0031] Figure 8 A side, partially cut-away view of one embodiment of the present invention is shown.

[0032] Fig. 8A A top perspective view of one embodiment of the present invention is shown.

[0033] Fig. 9A A perspective cross-sectional view of one embodiment of the present invention is shown.

[0034] Fig. 9B A perspective cross-sectional view of one embodiment of the present invention is shown.

[0035] Fig. 9C A perspective cross-sectional view of one embodiment of the present invention is shown.

[0036] Fig.9D A perspective cross-sectional view of one embodiment of the present invention is shown.

[0037] Fig. 10A A perspective cross-sectional view of one embodiment of the present invention is shown.

[0038] Fig. 10B A perspective cross-sectional view of one embodiment of the present invention is shown.

[0039] Fig. 10C A perspective cross-sectional view of one embodiment of the present invention is shown.

[0040] Fig. 10D A perspective cross-sectional view of one embodiment of the present invention is shown.

[0041] Fig.11A A perspective cross-sectional view of one embodiment of the present invention is shown.

[0042] Fig. 11B A perspective cross-sectional view of one embodiment of the present invention is shown.

[0043] Fig. 11C A perspective cross-sectional view of one embodiment of the present invention is shown.

[0044] Fig.11D A perspective cross-sectional view of one embodiment of the present invention is shown. DETAILED DESCRIPTION

[0045] With reference to the accompanying drawings, Figure 3An embodiment of a guide extension catheter 100 of the present invention is illustrated. Thus, the guide extension catheter 100 includes a flexible tube segment 102, which is shown to be covered with a material such as, for example, but not limited to, a polymer (e.g., PTFE, etc.). The flexibility of the flexible tube segment 102 can vary or change, such as increasing in the distal direction or in the proximal direction, or the flexibility can be constant along the length of the flexible tube segment. A flexible tip 103 is disposed at the distal end of the flexible tube segment 102, and a radiopaque marker 104 can be disposed at or near the distal and / or proximal ends of the flexible tube segment 102. As shown, the distal radiopaque marker 104 is just proximal to the tip 103. Another radiopaque marker 106 can be disposed at or near the proximal end of the flexible tube segment 102. Both the distal radiopaque marker 104 and the proximal radiopaque marker 106 are shown as "bands", but other marker configurations such as radiopaque deposits or coatings can also be considered and are also within the scope of the present invention.

[0046] At least a portion of the flexible tube section 102 may be formed or reinforced by a structure that provides a tubular shape and desired flexibility and other operational characteristics. For example, a laser cut hypotube, braid, and / or relatively wound coil may be employed with an outer polymer covering, coating, or sheath as described above.

[0047] In some embodiments of the present invention, the flexible reinforced tube segment 102 and / or the proximal portion that may not be reinforced can transition to a proximally positioned semicircular segment, which can include a tapered partial cone or flare, or can include a partial cylinder, wherein the semicircular shape of the proximally positioned semicircular segment is interrupted by a flattened bottom section, which will be further discussed below.

[0048] In other embodiments, the flexible reinforced tube segment 102 can transition to a complete tapered partial cone or flare located proximally, or a complete cylinder, wherein the semi-circular shape of the proximally located semi-circular portion is not interrupted by a flat bottom segment, as will be discussed further below. In some embodiments, the flat bottom segment can include a component that is manufactured to be flat, and does not require the component to start out as a non-flat shape and then be flattened.

[0049] exist Figure 3In the illustrated embodiment, the flexible reinforced tube segment 102 transitions at the proximal region into a semicircular segment that includes a partial or interrupted, flared or partially tapered segment 108, wherein the inner and outer diameters of the partially flared segment 108 taper and become larger as one moves in the proximal direction, and wherein the inner and outer diameters of the flexible reinforced tube segment 102 are smaller than the inner and outer diameters at any point along the partially flared segment 108. Figure 3 As shown, the partially flared section 108 is an intermittent or incomplete or asymmetrical flare or taper that includes a flat lower surface 110, such that the partially flared section 108 includes a semicircular structure that has a straight or flat lower surface 110 at any longitudinal cross-section of the partially flared section 108 and is therefore not a fully flared or tapered structure. The partially flared section 108 terminates at the proximal end at an angle that is substantially perpendicular to the central longitudinal axis A without tapering or chopping.

[0050] The flat lower surface 110 is shaped to complement a flat band section 112, which is at least partially arranged along the flat lower surface 108 of the partially flared section 108, and is therefore within the range of or surrounded by the partially flared section 108, and in some embodiments, can also extend distally for a distance into the flexible tube section 102 and extend along the flexible tube section 102, and the flexible tube section 102 can extend proximally until it extends to the partially flared section 108.

[0051] The flat band segment 112 can be operably connected to the proximal portion or proximal extension of the tube segment 102, for example, by welding or brazing or snap fit. As shown, the flat band segment 112 can be configured to extend along the flat lower surface 110 and slightly extend into the inner diameter ID of the partial flared segment 108. In other embodiments, the flat band segment 112 can occupy space within the polymer so as not to affect the inner diameter ID of at least a portion of the flared segment 108. The flat band segment 112 can be operably connected to the proximal portion or proximal extension of the flexible tube segment 102, for example, by welding or brazing or snap fit. Similarly, in an embodiment comprising the flat band segment 112 extending distally through the partial flared segment 108 into the flexible tube segment 102, the flat band segment 102 can reduce the nominal ID of the flexible tube. Figure 4A One such embodiment is shown by the dashed line in FIG. 1 extending distally along the length of the flat ribbon segment 112 to operably connect with an exemplary laser cut tube.

[0052] In other embodiments, the flat ribbon section 112 may be disposed within the polymer-encapsulated wall W of the partially flared section 108, and in some embodiments as discussed above, into the wall W' of the flexible pipe section 102, so as not to reduce the nominal inner diameter ID of the partially flared section 108, or again in some embodiments, the nominal inner diameter of the flexible pipe section 102. Figure 4A and Figure 4B As shown, the flat band segment 112 can be positioned at the distal end of a push rod 114, which can include a handle 116 disposed at the proximal end of the push rod 114. An operator can manipulate the handle 116 external to the patient during an endovascular procedure to translate and / or rotate the guide extension instrument 100, and in particular, translate and / or rotate the position of the instrument 100 within the patient's vasculature.

[0053] Figure 4A and Figure 4B An embodiment of a flexible reinforced tube section 102 formed from a spiral laser cut tube 118 is illustrated. As shown, and with continued reference to Figure 3 The pitch (or distance) P between the cut lines in the longitudinal direction or along a central axis A (not shown but defined by the tube segment 102 and the partially flared segment 108) corresponding to the central longitudinal axis of the lumen is constant, and the angle α of the spiral cut relative to a line perpendicular to the axis A (e.g. Figure 4B ) is also constant along the length of the flexible reinforced tube section 102.

[0054] form Figure 4A and Figure 4B The helical laser cut tube 110 of the flexible reinforced tube segment 102 is illustrated as including a distal marker band 104 and a proximal marker band 106, and having an additional proximally extending portion 120 of the flexible tube, and the semicircular segment shown as a partial flare 108 is shown as not including a laser cut tube or a hypotube structure. In other words, an embodiment may include a proximal portion that may include a proximal portion 120 and a more proximal partially flared segment 108 of the flexible tube 102, both of which are formed of a polymer (e.g., PTFE) or related material operably connected to the laser cut tube 118 and / or the radiopaque marker 106 interposed therein as shown, wherein the reinforcing structure (e.g., the laser cut tube 110) does not extend proximally into the proximal portion 120 and / or the proximal partially flared segment 108. In other embodiments, the spiral laser cut tube 118 can extend through segments including the proximal and / or distal radiopaque markers 104, 106, and / or a more proximal flexible tube segment 120 and / or through at least a portion of the partially flared segment 108 to provide shaping and / or flexibility or other support to the proximal segment 120 and / or the partially flared segment 108 of the flexible tube segment 102.

[0055] Figure 5 An embodiment of an exemplary guide extension catheter 100 is shown, and the exemplary guide extension catheter 100 includes Figure 4A and Figure 4B The flexible tube segment 102 is formed by a spiral laser cut tube 118', wherein the pitch or longitudinal distance P between the cut lines (shown as P1 having a length less than P2) increases from the distal end of the spiral laser cut tube 118' to the proximal end so as to modify the flexibility profile along the length of the spiral laser cut tube 118' and the flexible tube segment 102. Another embodiment may include setting the angle α of the cut relative to the central axis A (e.g. Figure 4B As shown) the laser cut tube increases or decreases along the spiral.

[0056] Figure 6 The example shows Figure 4A and Figure 4B The embodiment of the guide extension catheter 100 braid (BRAID) embodiment is similar, but instead of a helical laser cut tube forming the flexible tube segment 102, a braided structure 122 is provided. As is known in the art, the braid pitch and / or braid pic number can be selected to be constant along the length of the flexible tube, or can be modified to adjust or affect the longitudinal flexibility and other characteristics of the flexible tube described above.

[0057] Furthermore, at least a portion of the flexible pipe section 102 may include the Figure 4A , Figure 4B and Figure 5 The helical laser cut tubes 118 and / or 118 ′ described above, and at least one other portion of the flexible tube segment 102 may include a braided structure 122 in order to adjust and fine tune the operating characteristics of the flexible tube segment 102 .

[0058] Figure 7 It also shows something like Figure 4A and Figure 4BThe guide extension catheter 100 coil (COIL) embodiment of the present invention is similar to the above, but instead of the spiral laser cut tube 118, 118' and / or braid 122 as described above, the flexible tube segment 102 can be composed of two relatively wound coils 124, 125, wherein the upper coil 125 can be wound over the lower coil 124. The skilled person will recognize that two or more (e.g., 3) relatively wound coils can be employed in this manner. For example, a first lower coil can be wound over the liner 126, and a second intermediate coil is wound over the first lower coil in the opposite direction, and a third upper coil can be wound in the opposite direction relative 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 relative to a line perpendicular to the central axis A can be selected to be constant along the length of the flexible tube segment 102, or can be modified to adjust or affect the longitudinal flexibility of the flexible tube segment 102 and other features described above. The winding pitch of any given coil at any point along the length of the winding coil (e.g., 124, 125) can be 0 or greater than 0 and can vary along the longitudinal length of the winding coil. Thus, the flexibility can be modified, for example, increasing in the distal direction along the length of the flexible tube segment 102.

[0059] Furthermore, at least a portion of the flexible pipe section 102 may include the Figure 4A , Figure 4B and Figure 5 The spiral laser cut tube 118 and / or 118' and at least one other portion of the flexible tube 102 may include two or more oppositely wound coils (e.g., 124, 125), and / or at least one other portion of the flexible tube may include a braid 120 to adjust the operating characteristics of the flexible tube segment 102.

[0060] Now go to Figure 8 , provides an alternative and preferred REINFORCED embodiment of the guide extension catheter 100, similar to the above combined FIG. 4A to FIG. 7 The embodiment described above, however, has a proximal reinforcement region 200 (shown in phantom) disposed within or completely surrounded by at least a portion of the proximal flexible tube segment 20 and the partially flared segment 108. The proximal reinforcement region 200 includes a distal segment 202 that is truncated or tapered downward in the proximal direction, wherein it transitions to an intermediate non-tapered segment 203 that forms a flat bottom connector segment 204 via a tapered segment 206 that tapers proximally downward in the proximal direction. The intermediate non-tapered segment 203 forms a longitudinal semicircular shape with an open top region, as shown in FIG. 9A to 9DThe flat bottom connector portion 204 includes a notch or cutout 206 that is complementary in shape to the distal end of the flat strap segment 112 discussed above, such that the flat strap segment 112 may be operably interconnected with the notch or notch 206 by various means known to those skilled in the art, including, but not limited to, welding, brazing, and snap-fitting.

[0061] Fig. 8A One embodiment of a proximal reinforcement region 200 is illustrated, and shows a distal section 202 that is truncated or tapered downward in the proximal direction to transition into an intermediate non-tapered section 203 that includes an open semicircular shape along its longitudinal length. At the proximal end, the proximal reinforcement region 200 includes a bottom connector section 204 that may include a curvilinear shape to match the curvature of the surrounding polymer wall W. As shown, the bottom connector portion 204' may include a cutout or notch 206.

[0062] In all embodiments including the proximal reinforcement region 200, the interconnection between the flat strap segment 112 and the cutout or notch 206 is shown as including two flat interconnect structures 112 and 204, such that the flat strap segment 112 fits within the cutout or notch 206 and is secured by known means such as welding, brazing, and / or snap-fitting. However, as Fig. 8A As shown, in some embodiments, the flat strap section 112 may be modified to conform to or complement the curvilinear shape of the wall of the elongated flexible tube and / or the intermediate non-tapered section 203. In this embodiment, the cutout or notch 206 and the connector section may all include a curvature that is complementary to the curvature of the curved strap section to facilitate secure and operative engagement therebetween.

[0063] In some embodiments, the proximal reinforcement region 200 may be composed of Figure 4A and Figure 4B The proximal reinforcement region 200 is formed by spiral laser cutting the tube 118 and / or 118'. In other embodiments, the proximal reinforcement region 200 can be manufactured separately and then operably connected to the flexible tube segment 102 and the flat belt segment 112. Therefore, the proximal reinforcement region 200 can be used in combination with any of the embodiments of the flexible tube segment 102 discussed above.

[0064] As discussed, the proximal reinforcement region 200 may preferably be surrounded by or disposed within a polymer coating or sheath (e.g., PTFE or other material) and thus extend outwardly and proximally no further than the proximal-most end of the partially flared section 108. In other words, portions of the flexible tube 102 (e.g., the proximal portion 120 and the partially flared section 108 of the flexible tube section 102) completely surround and encircle the proximal reinforcement region 200. In some embodiments, the proximal reinforcement region 200 may be embedded within a polymer material that defines or surrounds and / or lines the proximal portion 120 and the partially flared section 108 of the flexible tube section 102.

[0065] Alternatively, in some embodiments, the proximal reinforced region 200 may be present as described above, but the resulting instrument includes a partial cylinder 210 rather than a partial flared section 108, wherein the partial cylinder 200 does not taper outwardly at the proximal end, but includes a flat lower surface 110' that is similar to the flat lower surface 110 of the partial flared section 108, is complementary in shape to the flat band section 112, and is configured for interconnecting the flat band section 112 with the notch or cutout 206.

[0066] 9A to 9D A proximal reinforced region 200R is illustrated for the proximal portion 120 of the flexible tube segment 102, and one of the following semicircular segments: the partial flared segment 108 and the partial cylindrical segment 210; or one of the following full semicircular segments: the full flared segment 108' and the full cylindrical segment 210', wherein in each embodiment, the proximal reinforced region 200R extends proximally no further than the most proximal end of the partial or full semicircular segment or the partial or full cylindrical segment of the illustrated embodiment.

[0067] therefore, 9A to 9DAn alternative embodiment of the proximal reinforcement region 200R as described above is illustrated and further includes a partial or semicircular support ring 212 disposed at or near the distal end of the flat bottom connector segment 204, or a curved bottom connector 204' (as shown), all of which remain completely surrounded by a portion of the flexible tube segment 102 and / or a partial flared segment 108, a full flared segment 108', a partial cylindrical segment 210, and / or a full cylindrical segment 210'. The partial or semicircular support ring 212 may be embedded within the material of the proximal portion 120 and / or the flare (partial and / or full) and / or cylinder (partial and / or full) of the flexible tube segment 102. The ring 212 extends circumferentially away from the flat bottom connector section 204 and / or the notch or cutout 206 on both sides of the proximal reinforcement section 200R to define an interrupted or partial or semicircular ring 212 while maintaining connectivity between the notch and the flat band. The partial ring 212 may be semicircular in shape to match the radius or curvature of the polymer wall W, and in some embodiments may include an upper surface parallel to the central axis A, and in other embodiments may taper upward and outward in the distal direction to match the taper of the partial flared section 108 (when present).

[0068] Fig. 9A A proximal reinforcement region 200R is illustrated having a partial or semicircular support ring 212 attached thereto and a complete flared section 108', ie without a flat bottom portion 110. Alternatively, Fig. 9B The same proximal reinforcement region 200R is provided, which has a partial or semi-circular support ring 212 and a partial flared section 108, as combined with Figure 4A and Figure 4B discussed.

[0069] Fig. 9C A proximal reinforcement region 200R is illustrated having a partial or semi-circular support ring 212 attached thereto, and instead of a flared section (full or partial), a full cylindrical section 210 ′ is provided, ie without a flat bottom portion 110 .

[0070] Fig.9D A proximal reinforcement region 200R is illustrated having a partial or semi-circular support ring 212 attached thereto, and a partial cylinder 200R at the distal end of the flexible tube 200 having a flat bottom section 110 to accommodate a flat band 112 interconnected with a defined cutout or notch 206 of the proximal reinforcement region 200R.

[0071] In all cases, the support ring 212 does not extend distally beyond the proximal-most end of the semicircular (partial or complete) segment and is therefore completely surrounded or encapsulated by the polymer wall W of the flexible tube segment 102 and / or the proximal portion 120 of the semicircular segment.

[0072] Fig. 10A An alternative proximal reinforcement section 200B is illustrated, similar to Figures 8 to 8A The proximal reinforcement section of the flexible tube and further includes an upper support beam 214 extending in a proximal direction away from the distal tapered section 202 along the flexible tube and the upper side of the flexible tube opposite the lower side of the cutout or notch 206 including the proximal reinforcement area 200B. The distal portion of the upper support beam 214 extends parallel to the central axis A along the proximal portion 120 of the flexible tube segment and, in some embodiments, may extend proximally along a semicircular segment (including, in some flared (partial or complete) embodiments, an additional distal portion 215) that tapers outwardly in the distal direction to match the outward taper of the flare, as shown. Fig. 10A A complete flared section 108 at the proximal end is illustrated, i.e., there is no flat bottom section. All elements of the proximal reinforcement region 200B, including the upper support beam, are surrounded by or embedded in the flexible tube and / or the entire flare and do not extend proximally beyond the most proximal end of the flared section 108.

[0073] Fig. 10B The example shows Fig. 10A An alternative proximal reinforcement section 200B of an embodiment of the present invention includes: Figure 4A and Figure 4B The upper support beam 214 and the partially flared section 108 are shown, and thus include a flat bottom section 110 to accommodate the flat band 112 and the interconnection between the flat band 112 and the cutout 206 defined by the proximal reinforcement area 200 as described above. All elements of the proximal reinforcement area 200B (including the upper support beam) are surrounded by or embedded in the flexible tube and / or the partially flared section 108 and extend proximally no further than the most proximal end of the partially flared section 108.

[0074] Fig. 10C Another alternative proximal reinforcement section 200B includes an upper support beam 214, wherein: Fig. 10A The complete flare 108 ′ is replaced by a complete cylindrical body 210 ′, wherein no portion of the proximal reinforcement section 200B, including the upper support beam 214 , extends proximally beyond the most proximal end of the complete cylindrical body 210 .

[0075] Fig. 10DAn alternative proximal reinforcement region 200B is illustrated that includes an upper support beam 214 and wherein the proximal reinforcement segment 200 includes a partial cylinder 210 having a flat bottom segment 110 configured to receive and engage the flat band 112 with the cutout 206 of the proximal reinforcement segment 200B. As with other embodiments, no portion of the proximal reinforcement segment 200B including the upper support beam 214 extends proximally beyond the most proximal end of the partial full cylinder 210.

[0076] Fig.11A Similar to Fig. 9A In an embodiment, the proximal reinforcement section 200E includes an expansion member 216 including an expandable portion 217 disposed at or near the distal end of the proximal reinforcement region 200 along the circumference of the support ring 212. The expandable portion 217 includes a structure that stretches under sufficient force. For example, but not limited to, a spring, a shock absorber, a coil, or multiple coils can be implemented. Figures 11A to 11D An exemplary z-shaped expandable portion 217 is shown. Thus, the expansion member 216 is configured to change circumference as the exemplary z-shaped expandable portion 217 is forced to expand when an outward radially directed force is applied thereto, wherein the shape of the "z" becomes more rectilinear and elongated, such as during translation of an interventional device. In some embodiments, an inwardly directed radial force may be required to shrink or collapse the expanded configuration back to an unexpanded configuration, or alternatively, the expandable portion 217 may be biased to return to the unexpanded configuration. Thus, the z-shaped expandable member embodiment 217 may move toward a more rectilinear form as it expands or compresses, or collapse radially when subjected to an expansion or compression force that exceeds a base threshold force. In a preferred embodiment, the expandable portion 217 may be formed of a shape memory material, such as nitinol, etc., having an undeformed static configuration and a deformed expanded configuration. Alternatively, the expandable portion 217 may be biased to an undeformed static configuration, but may expand if a force directed radially outward at least in part to overcome the biasing force is applied. Thus, the expansion member 216 with the expandable portion 217 provides a way to more easily translate an interventional instrument 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 Fig.11A The most proximal end of the fully flared portion 108.

[0077] Fig. 11B include Fig.11A An alternative embodiment of the proximal reinforcement section 200E, wherein: Fig.11A The complete flared section 108 ′ is replaced by a partial flared section 108 and wherein a flat bottom section 110 is provided.

[0078] Fig. 11C Another embodiment of a proximal reinforcement section 200E is provided, similar to Fig.11A but in which, Fig.11A The complete flared section 108 is replaced by a complete cylinder 210 .

[0079] Fig.11D Another embodiment of a proximal reinforcement section 200E is provided, similar to Fig. 11C The embodiment, however, now comprises a partial cylinder 210 having a flat lower surface 110 ′.

[0080] The description of the present invention and its application set forth herein is illustrative and is not intended to limit the scope of the present invention. The features of various embodiments can be combined with other embodiments within the present invention's expectation. Modifications and modifications of the embodiments disclosed herein are possible, and those of ordinary skill in the art will understand the actual replacement and equivalents of the various elements of the embodiments when studying this patent document. These modifications and modifications and other modifications and modifications can be made to the embodiments disclosed herein without departing from the scope and spirit of the present invention.

Claims

1. A guide extension catheter, comprising: A flexible pipe section having A flexible reinforced portion, the flexible reinforced portion comprising one or more of the group consisting of: a laser cut tube; a braid; and at least two relatively wound coils, a proximal reinforcement section, the proximal reinforcement section being disposed proximal to the flexible reinforced portion; and a semicircular section disposed proximally of the proximal reinforcement section and including a flat bottom section; a flat band section connected to a proximal portion of the proximal reinforcement section portion and extending proximally along the flat bottom section of the semicircular section; as well as a push rod operably connected to the proximal portion of the flat belt segment, the push rod including a proximal handle, wherein the flexible pipe section is coated with a polymer defining a wall, and Wherein, the proximal reinforcement section extends proximally no further than the proximal end of the semicircular section.

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

3. The guide extension catheter according to claim 1, wherein: The proximal reinforcement section includes a flat or curvilinear bottom connector section, and wherein the flat strap section is connected to the flat or curvilinear bottom connector section.

4. The guide extension catheter according to claim 3, wherein: The proximal reinforcement section further comprises: a truncated distal section that tapers downward in a proximal direction; an intermediate non-tapered section having a longitudinally open semicircular shape, Downward in the proximal direction to meet the flat bottom connector section, wherein the proximal end of the flat or curved bottom connector section defines a cutout that is complementary in shape to the distal end of the flat band section, whereby the flat band section is operably connected within the cutout and thereby connected to the proximal reinforcement section.

5. The guide extension catheter according to claim 4, wherein: The connected flat strip sections do not reduce the inner diameter of the flexible tube section.

6. The guide extension catheter of claim 4, wherein: The connected flat strip sections reduce the inner diameter of the flexible tube section.

7. The guide extension catheter of claim 1, wherein: The semicircular section comprises a partially tapered flared shape.

8. The guide extension catheter of claim 1, wherein: The semicircular section comprises a partial cylindrical shape.

9. The guide extension catheter of claim 1, wherein: The laser cutting of the tube comprises spiral cutting, wherein the flexible tube section comprises a central longitudinal axis, wherein the spiral cutting comprises a pitch and an angle relative to the central axis, and Wherein, the pitch and angle are constant when moving along the laser cutting tube from the distal side to the proximal side.

10. The guide extension catheter of claim 1, wherein: The laser cutting of the tube comprises spiral cutting, wherein the flexible tube section comprises a central longitudinal axis, wherein the spiral cutting comprises a pitch and an angle relative to the central axis, and Wherein, the pitch and angle are not constant when moving along the laser cut tube from the distal to the proximal direction.

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

12. A guide extension catheter comprising: A flexible pipe section having A flexibility enhancement portion, the flexibility enhancement portion comprising one or more of the group consisting of: a laser cut tube; a braid; and at least two coils wound opposite to each other, a proximal reinforcement section, the proximal reinforcement section being arranged proximal to the flexibility enhanced portion and comprising: a truncated distal section that tapers downward in a proximal direction; a middle non-tapered section having a longitudinally open semicircular shape; a flat or curvilinear bottom connector section having a proximal end defining a cutout, and a semicircular support ring connected to the flat or curved bottom connector section; a semicircular section disposed proximally of the proximal reinforcement section and including a flat bottom section, and a flat strap section extending along the flat bottom section of the semicircular section, wherein the flat strap section is operably connected within the cutout defined by the flat or curvilinear bottom section; and a push rod operably connected to the proximal portion of the flat belt segment, the push rod including a proximal handle, wherein the flexible pipe section is coated with a polymer defining a wall, and Wherein, the proximal reinforcement section extends proximally no further than the proximal end of the semicircular section.

13. The guide extension catheter of claim 12, wherein: The proximal semicircular section includes a partially conical flared shape.

14. The guide extension catheter of claim 12, wherein: The proximal semicircular section comprises a partial cylindrical shape.

15. The guide extension catheter of claim 12, wherein: The semicircular support ring includes an expansion member and further includes an expandable portion, wherein the expandable portion is configured to achieve an undeformed, unexpanded configuration and is configured to expand to a more deformed configuration when subjected to a radially outward force.

16. The guide extension catheter of claim 15, wherein: The expandable portion is biased to maintain the undeformed configuration.

17. The guide extension catheter of claim 15, wherein: The expandable portion includes a shape memory material.

18. The guide extension catheter of claim 15, wherein: The expansion member comprises a z-shape in the undeformed configuration.

19. A guide extension catheter comprising: A flexible pipe section having A flexible reinforced portion, the flexible reinforced portion comprising one or more of the group consisting of: a laser cut tube; a braid; and at least two relatively wound coils, a proximal reinforcement section, the proximal reinforcement section being disposed proximal to the proximal flexible tube portion; as well as A complete conical expansion section, the complete conical expansion section is arranged at the proximal side of the proximal reinforcement section, the complete conical expansion section includes some longitudinal cross sections of a complete circle; a flat belt section connected to a proximal portion of the increased flexibility portion of the flexible tube section; as well as a push rod operably connected to the proximal portion of the flat belt segment, the push rod including a proximal handle, wherein the flexible pipe section is coated with a polymer defining a wall, and Wherein, the proximal reinforcement section extends proximally no further than the proximal end of the complete conical expansion section.

20. A guide extension catheter comprising: A flexible pipe section having a flexibility-enhanced portion, the flexibility-enhanced portion comprising one or more of the group consisting of: a laser cut tube; a braid; and at least two relatively wound coils, a proximal flexible tube portion, the proximal flexible tube portion being disposed proximal to the laser cut tube, a proximal reinforcement section disposed proximal to the proximal flexible tube portion; as well as a full cylindrical section, the full cylindrical section being disposed proximal to the proximal reinforcement section, the full cylindrical section not including a flat bottom section; a flat belt section connected to a proximal portion of the increased flexibility portion of the flexible tube portion; as well as a push rod operably connected to the proximal portion of the flat belt segment, the push rod including a proximal handle, wherein the flexible pipe section is coated with a polymer defining a wall, and Wherein, the proximal reinforcement section extends proximally no further than the proximal end of the complete cylindrical section.

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