Variable flexible catheter support frame

Abstract

To provide a guide catheter extension part which controls torque property and flexibility, in an important point in a length of a catheter.SOLUTION: A guide catheter extension part includes: a pressing member 1001 having a lumen, a proximal end 1003 and a distal end 1004; a tube frame 1005 defining a lumen 1002 therein, a longitudinal axis 1009, a proximal segment 1010 and a distal segment 1011, the tube frame comprising multiple notch patterns therein; and a tongue piece element extending from the proximal segment of the tube frame, the tongue piece element being coupled to the pressing member.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application No. 62 / 729,282, filed on Sep. 10, 2018, the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] In coronary artery disease, the coronary arteries can be narrowed or occluded by atherosclerotic plaques or other lesions. These lesions can completely occlude the lumen of the artery or can dramatically narrow the lumen of the artery. To diagnose and treat obstructive coronary artery disease, it is generally necessary to pass a guide wire or other interventional device through and beyond the occlusion or stenosis of the coronary artery. Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a therapeutic technique used to treat stenotic portions of the coronary arteries of the heart due to lesions or occlusions in the coronary arteries.

[0003] In PCI, a guide catheter is used to assist in easier passage of another catheter or interventional device, for example, a micro - catheter, stent, or balloon, to access the target site. For example, the guide catheter can be inserted through the aorta into the small openings of the coronary arteries. After being placed at the opening or small opening of the coronary artery, a guide wire or other instrument can be passed through the lumen of the guide catheter and then inserted into the artery distal to the occlusion or stenosis. Another example of the use of a guide catheter is to effectively perform femoral artery intervention using radial access or pedal access by the guide catheter. ​​​​​​​​​This can be seen in femoral popliteal artery interventions. Ruza et al. JAAC 11:10 62(2018).

[0004] However, guide catheters can encounter certain problems. The area for placement, for example, in the coronary vasculature, the anatomical structure may be tortuous, and the lesion itself may be relatively non-compliant. Further, when crossing a relatively non-compliant lesion, sufficient backward force can be generated to remove the guide catheter from the small holes of the artery being treated . To improve adjunctive support, U.S. Patent No. RE45,830 discloses a coaxial guide catheter adapted to be passed through a guide catheter. The distal portion of the coaxial guide catheter can extend distally from the distal end of the guide catheter. The coaxial guide catheter includes a flexible tip portion that defines a tubular structure having a lumen through which interventional heart devices such as stents and balloons can be inserted. . In disclosed or available guide catheter extension devices, it is necessary to construct different tube portions with different characteristics and join these tube portions together. For example, as disclosed in U.S. Patent No. RE45,830, the catheter extension includes a catheter tube portion that includes a soft tip, an inner liner component, and a reinforcing portion of the catheter body that is braided or wound over the inner liner (flat wire or round wire braided composition or flat metal coil or round metal coil), and a melted or re-applied coaxial guide catheter adapted to be passed through a guide catheter. The distal portion of the coaxial guide catheter can extend distally from the distal end of the guide catheter. The coaxial guide catheter includes a flexible tip portion that defines a tubular structure having a lumen through which interventional heart devices such as stents and balloons can be inserted. The distal portion of the coaxial guide catheter can extend distally from the distal end of the guide catheter. The coaxial guide catheter includes a flexible tip portion that defines a tubular structure having a lumen through which interventional heart devices such as stents and balloons can be inserted. The coaxial guide catheter includes a flexible tip portion that defines a tubular structure having a lumen through which interventional heart devices such as stents and balloons can be inserted. The coaxial guide catheter includes a flexible tip portion that defines a tubular structure having a lumen through which interventional heart devices such as stents and balloons can be inserted.

[0005] In disclosed or available guide catheter extension devices, it is necessary to construct different tube portions with different characteristics and join these tube portions together. For example, as disclosed in U.S. Patent No. RE45,830, the catheter extension includes a catheter tube portion that includes a soft tip, an inner liner component, and a reinforcing portion of the catheter body that is braided or wound over the inner liner (flat wire or round wire braided composition or flat metal coil or round metal coil), and a melted or re-applied coaxial guide catheter adapted to be passed through a guide catheter. The distal portion of the coaxial guide catheter can extend distally from the distal end of the guide catheter. The coaxial guide catheter includes a flexible tip portion that defines a tubular structure having a lumen through which interventional heart devices such as stents and balloons can be inserted. The catheter tube portion includes a soft tip, an inner liner component, and a reinforcing portion of the catheter body that is braided or wound over the inner liner (flat wire or round wire braided composition or flat metal coil or round metal coil), and a melted or re-applied component. The inner liner is a flat wire or round wire braided composition or flat metal coil or round metal coil. The catheter body is braided or wound over the inner liner (flat wire or round wire braided composition or flat metal coil or round metal coil), and a melted or re-applied component. The inner liner is a flat wire or round wire braided composition or flat metal coil or round metal coil. A polymer cover section that covers (e.g., Pebax, nylon, or other polymer materials ) and a substantially rigid portion that can be made from a stainless steel or nitinol tube may be included. RE46,116, RE45,760.

[0006] Another example of a guide catheter design shows that a guide catheter having a color transition section is made from a material different from that of the tubular portion. Here, the tubular portion is formed from a multifilament braided wire to reinforce the polymer section. See, for example, U.S. Patent No. 8,048,032, U.S. Patent No. 8,996,095, U.S. Patent No. 9,3 52,123, U.S. Patent No. 9,687,634, U.S. Patent No. 9,764,118, and U.S. Patent No. 9,993,613. However, these multi-component designs and manufacturing requirements may limit mechanical properties and complicate manufacturing.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

[0008] [Non-Patent Document 1] Ruza et al.JAAC 11:1062(2018) Summary of the Invention [Problem to be solved by the invention]

[0009] Thus, the catheter body and catheter segment, e.g., a guide catheter Improved designs for extensions, and more generally, ease of manufacture as well as Various properties of the tube, such as axial torque transmission, steerability, and variable length along the working length, Control of bending flexibility, pushability, crush or kink resistance at any point along the tube

[0005] There remains a need for alternative designs for catheter tubes that allow Physicians can assess the various complex and numerous diseases that are often found in the coronary, peripheral or neurovascular systems. In order to allow access through the tortuous anatomical vasculature, It is important to control the torque and flexibility at key points along the length of the cable. [Means for solving the problem]

[0010] The present disclosure provides a pusher member having a lumen, a proximal end and a distal end, A tube frame defining a hand axis, as well as a proximal segment and a distal segment. a tube frame having a plurality of cut patterns therein; and a tongue element extending from a proximal segment of said pusher member, said tongue element being connected to said pusher member; Provide a guide catheter extension including. The pushing member has a plurality of cut patterns therein It may include. The pushing member may include a plurality of intermittent spiral cut patterns.

[0011] The cut pattern of the tube frame may include a plurality of intermittent spiral cut patterns It can be. The plurality of intermittent spiral cut patterns may extend along the length of a tube frame having an average stiffness of 0.002 to 0.004 N / mm. The plurality of intermittent spiral cut patterns may extend along the length of a tube frame having an average stiffness of 0.003 N / mm. The plurality of intermittent spiral cut patterns may extend along the length of a tube frame having an average stiffness of 0.003 N / mm. It can be.

[0012] The cut pattern of the tube frame may include a continuous spiral cut pattern. The continuous spiral cut pattern may extend along the length of a tube frame having an average stiffness of 0.001 to 0.003 N / mm. The continuous spiral cut pattern may extend along the length of a tube frame having an average stiffness of 0.001 to 0.003 N / mm. The continuous spiral cut pattern may extend along the length of a tube frame having an average stiffness of 0.002 N / mm. The continuous spiral cut pattern may extend along the length of a tube frame having an average stiffness of 0.002 N / mm.

[0013] The cut pattern of the tube frame may include a plurality of rings connected together by a plurality of struts. The rings are spaced apart from each other by the cut width. Each ring has a width, and each strut has a width and a length. The plurality of rings may extend along the length of a tube frame having an average stiffness of 0.005 to 0.016 N / mm N / m m. The rings may be oriented perpendicular to the longitudinal axis of the tube frame. The rings may be disposed at the distal segment of the tube frame. The plurality of struts may form at least one spiral pattern at the distal segment of the tube frame. The plurality of struts may be in the longitudinal direction of the tube frame. It can be. m. The rings may be oriented perpendicular to the longitudinal axis of the tube frame. The rings may be disposed at the distal segment of the tube frame. The plurality of struts may form at least one spiral pattern at the distal segment of the tube frame. The plurality of struts may be in the longitudinal direction of the tube frame. It can be. It can be arranged at the distal segment of the tube frame. The plurality of struts can form at least one spiral pattern at the distal segment of the tube frame. The plurality of struts can be in the longitudinal direction of the tube frame. One spiral pattern can be formed. The plurality of struts may be in the longitudinal direction of the tube frame. It may be aligned with at least one line running substantially parallel to the axis. The struts are rings They can be arranged every other one. The struts in adjacent rings may be angularly offset from each other at a radial direction angle in the range of about 5 degrees to about 180 degrees. The virtual plane formed by bisecting the tube frame at the proximal end of the tube frame can be perpendicular to the longitudinal axis of the tube frame.

[0014] The tube frame may include a plurality of protrusions extending from the proximal end of the tube frame. The protrusions may terminate at a plurality of points on a virtual plane perpendicular to the longitudinal axis of the tube frame. The protrusions may be connected to flares.

[0015] The cut pattern of the tube frame includes at least one zone along a part of the length of the tube, where the zone comprises a plurality of units, and the units of the zone are circumferentially distributed around the tube within at least one first band, and each unit of the zone comprises at least one notch segment oriented around a center of symmetry, and the center of symmetry of each unit within the band is equally spaced from the center of symmetry of an adjacent unit within the same band, and the center of symmetry of each unit is located at a point on the circumference of the tube that is the same as the center of symmetry of a second unit within a third band that is one band away from the first band; a tapered color transition section disposed adjacent to the tube, where the transition section has a tapered edge, a short end portion and a long end portion; and a pressing member attached to the long end portion of the transition section. At least one zone can extend along the length of the tube frame having an average stiffness of 0.002 to 0.004 N / mm. At least one zone may include. can extend along the length of the tube frame. At least one zone ​​​It can extend along the length of a tube frame having an average stiffness of 0.003 N / mm. Each unit includes three notch segments that extend radially from the center of symmetry of the unit. Each notch segment of the unit is from another notch segment within the unit within the band. They are arranged at an angle of 120°.

[0016] The guide catheter extension further includes seven zones, namely, the first zone, the second zone, the third zone, the fourth zone, the fifth zone, the sixth zone, and the seventh zone. Each zone is formed from a plurality of units, and the sequence of the notch surface area and the notch pattern and the peripheral length is: units of the first zone < units of the second zone < units of the third zone < units of the fourth zone < units of the fifth zone < units of the sixth zone < units of the seventh zone. The zones can be arranged sequentially as the first zone, the second zone, the third zone <, the fourth zone, the fifth zone, the sixth zone, and the seventh zone.

[0017] The notch pattern of the tube frame can include a single notch pattern. The notch pattern of the tube frame can include at least two notch patterns selected from the group consisting of a continuous spiral, an intermittent spiral, interconnected rings, and zones, or combinations thereof. At least one non-notch segment of the tube frame can be arranged between two notch patterns. At least one non-notch segment can be arranged along the tube frame.

[0018] At least a part of the lumen of the tube frame is polymer along the length of the tube. ​​​It may include a polymer liner bonded to the inner wall of the tube frame by at least one contact area between the ina and the inner wall. The polymer liner can form a tube, and the tube can be coaxially arranged within the lumen of the tube frame. The polymer liner may include at least two polymer layers, and each polymer layer has a different glass transition temperature. The polymer layer adjacent to the inner wall of the tube frame may have a lower glass transition temperature (melting temperature) than the polymer layer adjacent to the lumen of the tube frame. The polymer liner can be combined with the inner wall of the tube at a plurality of contact areas between the polymer liner and the inner wall along the length of the tube. The polymer liner can be continuously bonded to the inner wall of the tube frame along the length of the tube. The contact areas can be spaced apart from each other by a distance in the range of about 1 mm to about 2.5 cm along the longitudinal axis of the tube. The polymer liner can be bonded to the inner wall of the tube frame in a continuous spiral pattern running along at least a portion of the length of the tube frame. The polymer liner can be bonded to the inner wall of the tube frame by melting the polymer in the selected contact areas of the tube. The polymer liner can be bonded to the inner wall of the tube frame by an adhesive. The polymer layer adjacent to the inner wall of the tube can be a polyether block amide, and the polymer layer adjacent to the lumen of the tube frame can be polytetrafluoroethylene (PTFE). The polymer layer adjacent to the lumen of the tube frame can be coated with a lubricious material. The tube frame can be covered by an outer jacket, and the outer jacket can be coated with a lubricious material.

[0019]

[0020] The proximal segment of the tube frame is lower than the distal segment of the tube frame. It may have axial flexibility.

[0021] The pushing member can have a cross-sectional width in the range of about 0.25 mm to about 2.5 mm. The pushing member can have a cross-sectional width in the range of about 0.25 mm to about 0.76 mm. The pushing member can be constructed from a hypodermic tube having an inner lumen. The pushing member can define a substantially rectangular cross-section along a certain length. The length of the tube frame can be in the range of about 5 cm to about 150 cm, or alternatively in the range of about 50 cm to 100 cm.

[0022] The tube frame can include a plurality of protrusions extending from the proximal end of the tube frame and / or a plurality of protrusions extending from the distal end of the tube frame. The guide catheter extension portion can include a flare connected to a protrusion on the proximal end of the tube frame, and the flare is constructed from a poly mer. The catheter tip can be connected to a protrusion on the distal end of the tube frame, and the catheter tip is constructed from a polymer. The polymer can be impregnated with a radiopaque material.

[0023] The tube frame can be constructed from nitinol or spring steel.

[0024] On both sides of the tongue piece element, two cuts can be disposed within the tube frame, and each cut runs substantially parallel to the longitudinal axis of the tube. Each of the cuts can terminate within the proximal segment of the tube frame at a keyhole.

[0025] The present disclosure relates to a pushing member having a proximal end and a distal end, and a tube ​​​​​A tube frame having a diameter sufficient to receive an interventional vascular device therethrough A guide catheter extension comprising a lumen having a diameter sufficient to receive an interventional vascular device therethrough and a tube frame defining an inner wall wherein the tube frame includes a distal segment having a plurality of rings, each of the rings being interconnected by a plurality of connectors and a tongue extending from a proximal segment of the tube, the tongue being connected to a push member, providing a guide catheter extension The connections between adjacent rings of the plurality of connectors may be axially aligned. The connections between adjacent rings of the plurality of connectors may be angled offset from each other at an angle in the range of about 5 degrees to about 180 degrees. The plurality of connectors may form a helical pattern along the distal segment of the tube frame

[0026] The connections between adjacent rings of the plurality of connectors may be axially aligned. The connections between adjacent rings of the plurality of connectors may be angled offset from each other at an angle in the range of about 5 degrees to about 180 degrees. The plurality of connectors may form a helical pattern along the distal segment of the tube frame The connections between adjacent rings of the plurality of connectors may be axially aligned. The connections between adjacent rings of the plurality of connectors may be angled offset from each other at an angle in the range of about 5 degrees to about 180 degrees. The plurality of connectors may form a helical pattern along the distal segment of the tube frame The connections between adjacent rings of the plurality of connectors may be axially aligned. The connections between adjacent rings of the plurality of connectors may be angled offset from each other at an angle in the range of about 5 degrees to about 180 degrees. The plurality of connectors may form a helical pattern along the distal segment of the tube frame The connections between adjacent rings of the plurality of connectors may be axially aligned. The connections between adjacent rings of the plurality of connectors may be angled offset from each other at an angle in the range of about 5 degrees to about 180 degrees. The plurality of connectors may form a helical pattern along the distal segment of the tube frame

[0027] A polymer liner may be disposed within the lumen and may extend through a plurality of interconnected rings. The polymer liner may include at least two polymer layers, each polymer layer having a different glass transition temperature, and the polymer layer adjacent to the inner wall of the tube frame has a lower glass transition temperature (melting temperature) than the polymer layer adjacent to the lumen A polymer liner may be disposed within the lumen and may extend through a plurality of interconnected rings. The polymer liner may include at least two polymer layers, each polymer layer having a different glass transition temperature, and the polymer layer adjacent to the inner wall of the tube frame has a lower glass transition temperature (melting temperature) than the polymer layer adjacent to the lumen A polymer liner may be disposed within the lumen and may extend through a plurality of interconnected rings. The polymer liner may include at least two polymer layers, each polymer layer having a different glass transition temperature, and the polymer layer adjacent to the inner wall of the tube frame has a lower glass transition temperature (melting temperature) than the polymer layer adjacent to the lumen A polymer liner may be disposed within the lumen and may extend through a plurality of interconnected rings. The polymer liner may include at least two polymer layers, each polymer layer having a different glass transition temperature, and the polymer layer adjacent to the inner wall of the tube frame has a lower glass transition temperature (melting temperature) than the polymer layer adjacent to the lumen

[0028] The guide catheter extension may include an outer polymer jacket covering at least a portion of the plurality of rings, the outer polymer jacket not being fused to any portion of the plurality of rings The guide catheter extension may include an outer polymer jacket covering at least a portion of the plurality of rings, the outer polymer jacket not being fused to any portion of the plurality of rings The guide catheter extension may include an outer polymer jacket covering at least a portion of the plurality of rings, the outer polymer jacket not being fused to any portion of the plurality of rings

[0029] The present disclosure is a guide catheter extension comprising a push member having a proximal region and a distal region and a tube frame connected to the distal end of the push member, the tube frame The present disclosure is a guide catheter extension comprising a push member having a proximal region and a distal region and a tube frame connected to the distal end of the push member, the tube frame A lumen having a diameter sufficient to receive an interventional heart device therethrough is defined by it through a tube frame, the tube frame having an average stiffness of about 0.03 N / mm to about 0.10 N / mm along its substantial length to provide a guide catheter extension. The tube frame can be pushed through a curve having a radius of about 2.5 mm without kinking . The tube frame can have a wall thickness of about 0.0254 mm to about 0 .254 mm. The tube frame can have a wall thickness of about 0.0635 mm to about 0.11 43 mm.

[0030] The guide catheter extension can include a polymer liner disposed at least partially within the lumen of the tube frame , the polymer liner being partially bonded to the tube frame . The polymer liner can have a wall thickness of about 0.00635 mm to about 0.127 mm . The polymer liner can be bonded to the tube frame at a plurality of discrete positions along the length of the tube , the width of each bond at each discrete position being about 1 mm to about 2 mm.

[0031] The guide catheter extension can include a plurality of rings disposed in the distal region of the tube frame , the width of each ring being about 50 microns to about 200 microns. Each ring can be spaced about 10 microns to about 300 microns from an adjacent ring.

[0032] The guide catheter extension can include an outer polymer jacket covering at least a portion of a plurality of interconnected rings , the outer polymer jacket not being fused to any portion of the plurality of interconnected rings , and the outer polymer jacket having a thickness of about 5 microns to about 1 It has a wall thickness of 0 microns.

[0033] The guide catheter extension includes a tongue element extending from the proximal segment of the tube frame and the tongue is connected to the pushing member.

Brief Description of the Drawings

[0034]

Figure 1A

Figure 1B

Figure 1C

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Figure 2E

Figure 2F

Figure 2G

Figure 2H

Figure 3

Figure 4A

Figure 4B

Figure 5

Figure 6A

Figure 6B

Figure 6C

Figure 7

Figure 8A

Figure 8B

Figure 8C

Figure 9A

Figure 9B

Figure 10A

Figure 10B

Figure 11A

Figure 11B

Figure 12

Figure 13A

Figure 13B

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19A

Figure 19B

Figure 19C

Figure 20A

Figure 20B

Figure 21A

Figure 21B

Figure 21C

Figure 21D

Figure 22A

Figure 22B

Figure 22C

Figure 22D

Figure 22E

Figure 22F

Figure 23A

Figure 23B

Figure 23C

Figure 24

Figure 25A

Figure 25B

Figure 25C

Figure 26A

Figure 26B

Figure 27A

Figure 27B

Figure 27C

Figure 28A

Figure 28B

Figure 29A

Figure 29B

Figure 29C

Figure 29D

Figure 30

Figure 31

Figure 32

Figure 33A

Figure 33B

Figure 33C

Figure 33D

Figure 34

Figure 35

Figure 36A

Figure 36B

Figure 36C

Figure 36D

Figure 37

Figure 38A

Figure 38B

Figure 38C

Mode for Carrying Out the Invention

[0035] The present disclosure provides an example of a guide catheter extension device. Referring now to FIGS. 1a - c, an example of a guide catheter extension 1000 is shown. The guide catheter extension 1000 is sized and configured to pass through a guide catheter and extend distally therefrom, as described herein. The guide catheter extension 1000 generally includes a push member 1001 coupled to a distal tube frame 1005. During use, the proximal region of the guide catheter extension 1000 is accessible or disposed external to the patient (e.g., at the proximal end or hub of a separate guide catheter), while the distal region of the guide catheter extension 1000 may have a sufficient length to extend distally outward from the end of the guide catheter disposed within the patient's anatomical structure. 000 includes a push member 1001 coupled to a distal tube frame 1005. During use, the proximal region of the guide catheter extension 1000 is accessible or disposed external to the patient (e.g., at the proximal end or hub of a separate guide catheter), while the distal region of the guide catheter extension 1000 may have a sufficient length to extend distally outward from the end of the guide catheter disposed within the patient's anatomical structure. 000 is sized and configured to pass through a guide catheter and extend distally therefrom, as described herein. The guide catheter extension 1000 generally includes a push member 1001 coupled to a distal tube frame 1005. During use, the proximal region of the guide catheter extension 1000 is accessible or disposed external to the patient (e.g., at the proximal end or hub of a separate guide catheter), while the distal region of the guide catheter extension 1000 may have a sufficient length to extend distally outward from the end of the guide catheter disposed within the patient's anatomical structure. 000 is sized and configured to pass through a guide catheter and extend distally therefrom, as described herein. The guide catheter extension 1000 generally includes a push member 1001 coupled to a distal tube frame 1005. During use, the proximal region of the guide catheter extension 1000 is accessible or disposed external to the patient (e.g., at the proximal end or hub of a separate guide catheter), while the distal region of the guide catheter extension 1000 may have a sufficient length to extend distally outward from the end of the guide catheter disposed within the patient's anatomical structure. 000 generally includes a push member 1001 coupled to a distal tube frame 1005. During use, the proximal region of the guide catheter extension 1000 is accessible or disposed external to the patient (e.g., at the proximal end or hub of a separate guide catheter), while the distal region of the guide catheter extension 1000 may have a sufficient length to extend distally outward from the end of the guide catheter disposed within the patient's anatomical structure. During use, the proximal region of the guide catheter extension 1000 is accessible or disposed external to the patient (e.g., at the proximal end or hub of a separate guide catheter), while the distal region of the guide catheter extension 1000 may have a sufficient length to extend distally outward from the end of the guide catheter disposed within the patient's anatomical structure. During use, the proximal region of the guide catheter extension 1000 is accessible or disposed external to the patient (e.g., at the proximal end or hub of a separate guide catheter), while the distal region of the guide catheter extension 1000 may have a sufficient length to extend distally outward from the end of the guide catheter disposed within the patient's anatomical structure. During use, the proximal region of the guide catheter extension 1000 is accessible or disposed external to the patient (e.g., at the proximal end or hub of a separate guide catheter), while the distal region of the guide catheter extension 1000 may have a sufficient length to extend distally outward from the end of the guide catheter disposed within the patient's anatomical structure. During use, the proximal region of the guide catheter extension 1000 is accessible or disposed external to the patient (e.g., at the proximal end or hub of a separate guide catheter), while the distal region of the guide catheter extension 1000 may have a sufficient length to extend distally outward from the end of the guide catheter disposed within the patient's anatomical structure.

[0036] The overall length of the guide catheter extension 1000 will depend on the particular procedure or application being performed and / or or the vascular access point utilized (e.g., radial artery, femoral artery, contralateral access, etc.) For example, the length of the guide catheter extension may vary depending on the length of the catheter. If the 1000 is being used to access coronary vessels, such as the left and right coronary arteries, the guide The total length of the catheter extension 1000 is about 110 cm (43.30 inches) to about 175 cm. m (68.89 in). For procedures involving peripheral vascular access, a guide catheter The total length of the tel extension 1000 is about 45 cm (17.72 inches) to about 300 cm (11 8.11 inches), and the extended length can be used to access the brachial or radial artery access points. This is useful for procedures involving

[0037] The pushing member 1001 is bent or kinked by the user. , without otherwise deforming and potentially occluding or damaging the guide catheter. The guide catheter extension 1000 can be moved through the interior of the guide catheter. While providing sufficient axial load or pushability to allow for the guide catheter The various curves and contours of the vasculature while the guide extension 1000 is positioned within the guide catheter. One or more metallic materials (such as steel) that provide sufficient flexibility to allow the bends to move. Stainless steel, polymers, ceramics and / or composites. obtain.

[0038] The pushing member 1001 may be, for example, a hypotube, a spiral cut hypotube, a multi-stranded tube, or the like. A flexible, intermittent spiral cut tube, other cut shapes / configurations, or one or more segments of one or more other elongate (1 or plural) members may be included, and may include one or more lumens 1002 for allowing one or more wires, devices, fluid delivery and / or suction functions, etc. to pass therein and / or therethrough. Alternatively, the push member 1001 may be constructed without having a lumen therein or therethrough.

[0039] The push member 1001 includes a small diameter or cross-sectional profile relative to the inner diameter or clearance of the guide catheter, reducing the amount of space within the guide catheter occupied by the push member 1001, thereby enabling one or more other devices, instruments or other things to pass through the guide catheter with minimal interference or obstruction. For example, the push member 10 01 may have a diameter or cross-sectional width of about 0.254 mm (0.010 inches) to about 2.54 mm (0.100 inches) for use with a guide catheter having an inner diameter of 1.1016 - 30.48 mm (0.04 - 1.20 inches). In a preferred example, the push member 1 001 may have a diameter or cross-sectional width of about 0.254 mm (0.010 inches) to about 0.762 mm (0.030 inches). The push member 1001 may have one or more cross-sectional shapes or profiles including, but not limited to, circular, semi-circular, square, rectangular, triangular and / or elliptical shapes along its length. Further, and / or alternatively, the push member 1001 may comprise a plurality of cut patterns in one or more of its sections

[0040] The push member 1001 may define a proximal end 1003 and a distal end 1004, and the guide catheter It may have an overall length that constitutes most of the length of the guide catheter extension 1000. The length of the pusher member 1001 is such that it can enter an incision or patient access point (which may include, for example, a hub, hemostatic valve, etc.), pass through the patient's vasculature, with a portion of the pusher member 1001 remaining outside the patient and being accessible / operable by a physician, while being sufficient to position the tube frame 1005 in proximity to the desired treatment site. The length can vary depending on the specific procedure or application being performed and / or the vascular access point used (e.g., whether introduced via the radial artery, femoral artery, contralateral access, etc.). The pusher member and / or other proximal portions of the guide catheter extension 1000 may include a stop function to prevent the physician from inserting the extension 1000 too far into the guide catheter. For example, the guide catheter extension 1000 may include a raised protrusion, weld, or other mass that exceeds the diameter or size of the guide catheter, hemostatic valve, and / or proximal device hub to mechanically prevent over-insertion of the guide catheter extension 1000. The pusher member and / or other proximal portions of the guide catheter extension 1000 may include a stop function to prevent the physician from inserting the extension 1000 too far into the guide catheter. For example, the guide catheter extension 1000 may include a raised protrusion, weld, or other mass that exceeds the diameter or size of the guide catheter, hemostatic valve, and / or proximal device hub to mechanically prevent over-insertion of the guide catheter extension 1000. The guide catheter extension 1000 may include a raised protrusion, weld, or other mass that exceeds the diameter or size of the guide catheter, hemostatic valve, and / or proximal device hub to mechanically prevent over-insertion of the guide catheter extension 1000. or other mass that exceeds the diameter or size of the guide catheter, hemostatic valve, and / or proximal device hub to mechanically prevent over-insertion of the guide catheter extension 1000. portion or other mass.

[0041] The tube frame 1005 includes or otherwise defines an outer wall 1007 and an inner wall 1006 that surround a lumen 1008, a longitudinal axis LA 1009, a proximal segment 1010, and a distal segment 1011. The tube frame 1005 has a proximal end 1012 and a distal end 1013, as well as a length L 1014. The tube frame 1005 has a plurality of cut pattern 1015, 1016 (note that 1015 and 1016 represent only two possible embodiments of the various cut patterns that may be present in the tube frame). frame). 。The tube frame 1005 has a tongue element 1017 extending from the proximal segment 1010 of the tube frame 1005, and the tongue element 1017 is connected to the pushing member 1001. In certain embodiments, the tongue element 1017 extends from the proximal end 1012 of the proximal segment 1010.

[0042] Both the proximal end 1012 and the distal end 1013 of the tube frame 1005 can each have protrusions 1019 and 1021. A flare or cap may be attached to the protrusion. This embodiment has a protrusion 1019 at the proximal end 1012, a flare 1018 on the proximal end, a protrusion 1021 at the distal end 1013, and is shown in FIGS. 1a - c with the tip 1023 attached to the protrusion 1021.

[0043] A portion of the tube frame 1005 can have a polymer liner 1022, and / or the outer wall 1007 of the tube frame 1005 can be covered (completely, partially, and / or intermittently) by an outer jacket 1020 (see, e.g., FIG. 30). The proximal end 1012 of the tube frame 1005, the end of the protrusion 1019 at the proximal end 1012 of the tube frame 1005, and the flare 1018 are each oriented perpendicular to the longitudinal axis LA1009 of the virtual plane that bisects the tube frame 1005.

[0044] The tube frame 1005 can be constructed from nitinol or stainless steel. For example, the tube frame can be made from metal, polymer, or a combination of polymer and metal. Examples of materials that can be used include stainless steel (SST), nickel titanium (nitinol), ​​​​​​​​​​​​​Preferred examples of other materials that may be used include superelastic nickel. Nickel titanium, shape memory nickel titanium, Ti-Ni, nickel titanium, about 55 to 60 weight Amount% of Ni, Ni-Ti-Hf, Ni-Ti-Pd, Ni-Mn-Ga, 300~400 series, e.g. 304, 316, 402, 440 SAE grade stainless steel (S ST), MP35N and 17-7 precipitation hardening (PH) stainless steels, other spring steels or or other high tensile materials or other biocompatible metallic materials. In one preferred embodiment In another preferred embodiment, the material is superelastic or shape memory (e.g., nickel titanium). In one embodiment, the material is stainless steel.

[0045] The tube frame 1005 may be assembled in its entirety or only selected sections thereof. Such alloys may include superelastic alloys (commonly referred to as "shape memory alloys"). Examples of superelastic alloys include Elgiloy® and Phynox® springs. Elgiloy® alloy is available from Carpen Corporation of Reading, Pennsylvania. Available from Ter Technology Corporation, Phynox (registered trademark) alloys available from Metal Imphy, Imphy, France, C Arpenter Technology Corporation and Pennsylvania SAE Steel Corporation, Latrobe, AL Grade 316 stainless steel and MP35N (nickel-cobalt) alloy, as well as potassium Shape Memory Applications, Santa Clara, California and superelastic nitinol available from U.S. Patent No. 5,891,191.

[0046] Alternatively, the tube frame can be formed from a polymer, such as polyimide, PE EK, nylon, polyurethane, polyethylene terephthalate (PET), latex, HDHMWPE (high density high molecular weight polyethylene) and thermoplastic elastomers, or the same Other polymers having similar mechanical properties.

[0047] The tube frame 1005 can be made by forming a pipe of superelastic metal and then removing the portion of the pipe where notches or holes are to be formed. Notches, holes or incisions can be formed in the pipe by a laser (e.g., solid state, femtosecond laser or YAG laser), electric discharge (electrical discharge machining (EDM)), chemical etching, photoetching, mechanical cutting, or by using any combination of these techniques. U.S. Patent No. 5,879,381.

[0048] The overall length of the tube frame 1005 can vary depending on the particular procedure or application being performed and / or the vascular access point utilized (e.g., whether introduced via the radial artery, femoral artery, contralateral access, etc.). For example, if the guide catheter extension 100 0 is being used to access coronary vessels such as the radial artery or femoral artery, the overall length of the tube frame 1005 can be from about 10.16 cm (4 inches) to about 33.02 cm (13 inches). For procedures involving access to peripheral vessels, the overall length of the tube frame 1 005 can be from about 20.23 cm (8 inches) to about 91.44 cm (36 inches). (13 inches). For procedures involving access to peripheral vessels, the overall length of the tube frame 1 005 can be from about 20.23 cm (8 inches) to about 91.44 cm (36 inches).

[0049] ​​​​The tube frame 1005 can be sized sufficiently to allow an interventional heart device and / or instrument ( e.g., a therapeutic catheter, a stent delivery and / or retrieval device, a suction or occlusion treatment device, etc.) to be received therethrough while allowing the tube frame 1005 to pass through the inner diameter of a guide catheter.

[0050] The tube frame 1005 provides a combination of features that contribute to the function, operability, and performance of the guide extension catheter. For example, the tube frame 1005 should provide a desired degree of structural integrity to prevent the lumen 1008 of the tube frame 1005 from collapsing during use. The tube frame 1005 also contributes to both pushability and resistance to axial elongation or compression under axial loads while providing sufficient flexibility to move along the contours of anatomical structures both inside and outside of the guide catheter. To provide such features, the tube frame 1005 can be constructed from one or more metals, polymers, and / or composites thereof. In one embodiment, the tube frame 1005 can be constructed from nitinol or spring steel and can have a wall thickness in the range of about 0.0254 mm (0.001 inch) to about 0.254 mm (0.010 inch). In a preferred example, the tube frame 1005 can have a wall thickness in the range of about 0.0635 mm (0.0025 inch) to about 0.1143 mm (0.0045 inch).

[0051] In one embodiment, the cut pattern of the tube frame 1005 can form a series of or It is possible to distribute various cut patterns at any point along the length of the buffer frame 1005. In another embodiment, the helical cut path width includes alternating open or cut portions and non-cut portions 2005-2007. The helical path width is alternately composed of cut sections and non-cut sections and is angled with respect to the circumference of the tubular portion ( in other words, the pitch angle φ shown in FIG. 3 is less than 90°). Such a cut pattern can also be implemented on the pushing member 1001 to provide various degrees of pushability, flexibility, and overall operability of the guide catheter extension 1000.

[0052] As shown in FIG. 3, the non-cut portions oriented helically each have an arcuate range "α", and the cut portions oriented helically each have an arcuate range "β". The angles α and β can be expressed in degrees (each complete helical turn is 360°). The non-cut portions can be distributed such that adjacent non-cut portions are not axially aligned (or "staggered") with each other along a direction parallel to the longitudinal axis LA3009. The non-cut portions 3005 every other turn of the intermittent helical cut width can be axially aligned. The cut portions are shown as 3003 and 3004, and the helical pattern is labeled as 3001 and 3002. FIG. 3. The pitch angle φ and the distribution of the continuous or intermittent helical cut pattern can vary along the length L1014 of the tube frame 1005. The helical cut pattern of the tube frame 1005 can be a continuous helical cut section, an intermittent helical cut section, or a combination of both types of helical cut patterns. can be formed from a hybrid and various patterns can be arranged on the tube frame 1005 in any order obtainable.

[0053] The helical cut section provides axial torque for pushability, kink resistance, rotational response transmission, and / or a gradual transition in bending flexibility when measured by torque to breakage. For example, the helical cut pattern may have a pitch that varies to increase the flexibility of one or more regions of the tube frame 1005. The pitch of the helical cut can be measured by the distance between points at the same radial position of two adjacent threads. In one embodiment, the pitch of the helical cut may increase as it progresses from the proximal position to the distal end of the catheter. In another embodiment, the pitch of the helical cut may decrease as it progresses from the proximal position on the catheter to the distal end of the catheter. In this case the distal end of the catheter may be more flexible. By adjusting the pitch and cut as well as the non-cut path of the helical cut, the pushability, kink resistance, torque, flexibility and compression resistance of the tube frame may be controlled to meet the needs of the user. The helical cut pattern of the tube frame 1005 can be formed from a continuous helical cut section, an intermittent helical cut section, or a combination of both types of helical cut patterns, and various patterns can be arranged on the tube frame 1005 in any order. The intermittent cut helical module has the ability to maintain a concentric lumen region even with sharp bends of small radius while in a bent configuration. The tube frame 1005 As it progresses from the proximal position on the catheter to the distal end of the catheter, the pitch may decrease. In this case the distal end of the catheter may be more flexible. By adjusting the pitch and cut as well as the non-cut path of the helical cut, the pushability, kink resistance, torque, flexibility and compression resistance of the tube frame may be controlled to meet the needs of the user. The helical cut pattern of the tube frame 1005 can be formed from a continuous helical cut section, an intermittent helical cut section, or a combination of both types of helical cut patterns, and various patterns can be arranged on the tube frame 1005 in any order. The intermittent cut helical module has the ability to maintain a concentric lumen region even with sharp bends of small radius while in a bent configuration. The

[0054] The helical cut pattern of the tube frame 1005 can be formed from a continuous helical cut section, an intermittent helical cut section, or a combination of both types of helical cut patterns, and various patterns can be arranged on the tube frame 1005 in any order. The intermittent cut helical module has the ability to maintain a concentric lumen region even with sharp bends of small radius while in a bent configuration. The tube frame 1005 can be formed from a mixture of continuous helical cut sections, intermittent helical cut sections, or both types of helical cut patterns, and various patterns can be arranged on the tube frame 1005 in any order. The intermittent cut helical module has the ability to maintain a concentric lumen region even with sharp bends of small radius while in a bent configuration. The tube frame 1005 can be formed from a mixture of continuous helical cut sections, intermittent helical cut sections, or both types of helical cut patterns, and various patterns can be arranged on the tube frame 1005 in any order. The intermittent cut helical module has the ability to maintain a concentric lumen region even with sharp bends of small radius while in a bent configuration. The intermittent cut helical module has the ability to maintain a concentric lumen region even with sharp bends of small radius while in a bent configuration. The The ability to maintain a concentric lumen allows for smooth wire movement in any direction within the tubular lumen without deforming the lumen. Furthermore, by using a superelastic material such as nitinol for the helical cut segments, the segments can bend in sharp curves through various vascular pathways without permanently deforming the lumen.

[0055] Adjustment of flexibility / rigidity over the length of the tube frame 1005 can be achieved in several ways. For example, the flexibility / rigidity of the tube can be controlled by varying the helical cut pattern variables (pitch, intermittency) and transitioning between helical cut patterns. Furthermore, the helical cut pattern allows for maintaining the cross-sectional diameter of the lumen when the tube frame 1005 is bent or curved. Helical cut sections with different cut patterns may be distributed along the length of the tube. The helical cut pattern may be continuous or discontinuous along the length of the module. For example, there may be 1, 2, 3, 4, 5, 6, 7 to n helical cut sections along the length of the tube frame. The helical cut sections may be continuous or discontinuous. There may be a constant cut pattern within each section, but the cut pattern may vary, for example with respect to pitch, across various sections within the tube frame. Each section may also include a variable pitch pattern within a particular section. Each helical cut section may be, for example, in the range of about 0.05 mm to about 10 mm, for example, 0.1 mm, 0 .2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm .2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm , 0.9 mm, 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, etc. may have a fixed pitch. The pitch may also vary within each section and may be the same or different for different helical cut sections . The direction or winding method of the helical cut section may also vary within the helical cut section itself. The width of the helical cut can vary, for example, from about 1 micron to about 100 microns .

[0056] In the intermittent helical cut section, each turn or rotation of the helix can include a specific number of cuts (N c) (e.g., 1.5, 2.5, 3.5, 4.5, 5.5, etc.), and an intermittent helical pattern can be designed. Nc can be an integer such as 2, 3, 4, 5~n, or other real numbers such as 2.2, 2.4, 2.7, 3.1, 3.3, etc. For a given Nc, the non-cutting range α and the cutting range β can be selected as α = (360 - (β × Nc)) / Nc so that each rotation has Nc repeated patterns each having a cutting part in the range β adjacent to the non-cutting part in the range α. For example, when Nc = 1.5, 2.5, and 3.5, the following table shows selection examples of various embodiments for α and β .

Table 1

[0057] In another embodiment, the cut pattern of the tube frame 1005 includes a plurality of rings 40 01~4016 connected together by a plurality of connectors 40 The rings 4001 - 4017 are spaced apart from each other by a cut width of 4025 - 4030 (only labeled for the purpose of explanation). Fig. 4a. The ring is also referred to as an "interconnected ring". The interconnected ring can include one or more radiopaque markers 4050, or other visualization features that can be seen through one or more medical imaging modalities during a procedure (e.g., fluoroscopy, radiography, etc.). Such radiopaque points along the length of the plurality of rings and / or tube frame 1005 can be applied by inserting one or more radiopaque marker dots or rivets; through a mask coating such as plating or vapor deposition of gold or platinum at designated positions; by one or more marker rings around the tube frame 1005 that can be coaxially fixed as described herein, or by the arrangement of bands of material. Further, and / or alternatively, one or more polymer layers may be applied to portions of the plurality of rings and / or tube frame 1005 in which radiopaque materials and / or segments are embedded. (Only labeled for the purpose of explanation). Fig. 4a. The ring is also referred to as an "interconnected ring". The interconnected ring can include one or more radiopaque markers 4050, or other visualization features that can be seen through one or more medical imaging modalities during a procedure (e.g., fluoroscopy, radiography, etc.). Such radiopaque points along the length of the plurality of rings and / or tube frame 1005 can be applied by inserting one or more radiopaque marker dots or rivets; through a mask coating such as plating or vapor deposition of gold or platinum at designated positions; by one or more marker rings around the tube frame 1005 that can be coaxially fixed as described herein, or by the arrangement of bands of material. Further, and / or alternatively, one or more polymer layers may be applied to portions of the plurality of rings and / or tube frame 1005 in which radiopaque materials and / or segments are embedded. through a mask coating such as plating or vapor deposition of gold or platinum at designated positions; by one or more marker rings around the tube frame 1005 that can be coaxially fixed as described herein, or by the arrangement of bands of material. Further, and / or alternatively, one or more polymer layers may be applied to portions of the plurality of rings and / or tube frame 1005 in which radiopaque materials and / or segments are embedded. by one or more marker rings around the tube frame 1005 that can be coaxially fixed as described herein, or by the arrangement of bands of material. Further, and / or alternatively, one or more polymer layers may be applied to portions of the plurality of rings and / or tube frame 1005 in which radiopaque materials and / or segments are embedded. Further, and / or alternatively, one or more polymer layers may be applied to portions of the plurality of rings and / or tube frame 1005 in which radiopaque materials and / or segments are embedded. Further, and / or alternatively, one or more polymer layers may be applied to portions of the plurality of rings and / or tube frame 1005 in which radiopaque materials and / or segments are embedded. Further, and / or alternatively, one or more polymer layers may be applied to portions of the plurality of rings and / or tube frame 1005 in which radiopaque materials and / or segments are embedded.

[0058] The dimensions of the rings are shown as follows. Each ring has a width of 4031. Each ring is spaced apart from an adjacent ring by a cut width of 4033. Each connection 4018 - 4024 or strut has a length of 4035 and a width of 4037. Fig. 4b. Each of these parameters can vary across the plurality of rings. The path around the tube frame 1005 between any two pairs of rings, e.g., 4001 / 4002, 4002 / 4003, 4003 / 4004, 4004 / 4005, etc., has a set arc length of alternating cuts. Each ring has a width of 4031. Each ring is spaced apart from an adjacent ring by a cut width of 4033. Each connection 4018 - 4024 or strut has a length of 4035 and a width of 4037. Fig. 4b. Each of these parameters can vary across the plurality of rings. The path around the tube frame 1005 between any two pairs of rings, e.g., 4001 / 4002, 4002 / 4003, 4003 / 4004, 4004 / 4005, etc., has a set arc length of alternating cuts. The path around the tube frame 1005 between any two pairs of rings, e.g., 4001 / 4002, 4002 / 4003, 4003 / 4004, 4004 / 4005, etc., has a set arc length of alternating cuts. The path around the tube frame 1005 between any two pairs of rings, e.g., 4001 / 4002, 4002 / 4003, 4003 / 4004, 4004 / 4005, etc., has a set arc length of alternating cuts. The recessed section 4027 and the non-recessed section 4019 (also referred to as connection parts or struts in this specification) are formed. Fig. 4b. The dimensions of the cut width, the height of the ring, the width of the strut, and the length can be adjusted to achieve any desired flexibility or rigidity of the tube frame 1005.

[0059] The rings 5001-5007 (selected rings labeled only for the purpose of explanation in this specification) can be oriented perpendicular (or substantially perpendicular) to the longitudinal axis LA5008 of the tube frame 5009. In a preferred embodiment, a plurality of rings 5001-50 07 can be arranged on the distal segment 1011 of the tube frame 1005. Fig. 5. However, the rings can be arranged anywhere along the length L (1014) of the tube frame 1005. Fig. 5. However, the rings can be arranged anywhere along the length L (1014) of the tube frame 1005.

[0060] In a particular embodiment, the struts 5014-5016 can form a helical pattern over the length of the section of the tube frame having the rings. Fig. 5. In this embodiment the struts 5014-5016 are distributed over every adjacent ring, for example, 5020 / 50 21, 5021 / 5022 and 5022 / 5023. The struts of adjacent rings, for example, 5020 / 5021, 5021 / 5022 and 5022 / 5023 can be angularly offset from each other at an angle in the range of about 5 degrees to about 180 degrees (5, 10, 15, 30, 45, 60, 90 and 1 80 degrees).

[0061] Alternatively, the struts 6008-6011 (Fig. 6a) can be linearly aligned parallel to the longitudinal axis LA6013 of the tube frame 1005. In the embodiment shown in Fig. 6, ​ The struts 6008 - 6011 are arranged at intervals, one pair of rings apart. For example, rings 6002 and 6003 are connected by strut 6008, and rings 6004 and 6 005 are connected by strut 6009, but there is no strut at the same radial position between rings 6003 and 6004.

[0062] The plurality of rings 6001 (FIG. 6b) improve flexibility and allow the distal segment 1011 of the tube frame 1005 including the ring 6001 to move along a curve with a small radius of about 2.54 mm (0.1 inch). For example, the distal segment including the ring 6001 can bend at a 90 - degree angle without damaging or collapsing the ring 6001 or the lumen 1008 of the tube frame 1005, thus avoiding kinking of the guide catheter extension during use in ever - smaller anatomical structures or blood vessels. FIG. 6c. As shown here, the rings are distributed only over a portion of the tube frame 1005, but in other embodiments, the rings can be distributed over a substantial

[0063] The number of struts between any two rings can vary from 1 to 10, and 1 or 2 is the preferred number for the connection. In other examples, the number of struts can be more than 2, but the dimensions of the struts can be varied to maintain the desired degree of flexibility of the guide catheter extension. The angular offset of the struts, the spacing of the rings, and / or the height of each ring can vary in conjunction with the overall length of the plurality of rings to provide the desired degree of flexibility and pushability of the guide catheter extension through relatively small blood vessels.

[0064] The proximal segment 1010, or the distal segment 1011, of the tube frame 1005 Since the flexibility of the ring is increased compared to the flexibility of any other part of the distal segment 1011 defines a transition zone 7001 of intermediate flexibility that leads to a plurality of rings 6001 or may otherwise include it (FIG. 7). For example, the transition zone 7001 provides a flexibility or average rigidity that is between the average rigidity of the proximal region of the distal segment and the average rigidity of the ring, and may include a change in the notch pattern (e.g., notch width, angular orientation, pitch angle, etc.) compared to that of a relatively proximal section of the distal segment 1011. The transitional flexibility improves the ability of the guide catheter extension to navigate tortuous anatomical structures without internal lumen obstruction or kinking that might otherwise occur due to a sharp and significant change in rigidity across the distal section of the guide catheter extension.

[0065] Another embodiment of the cut pattern of the tube frame 1005 of the present disclosure is shown in FIGS. 8a - c. The zones may be present in single or multiple segments along any part of the tube frame, e.g., within the proximal segment 1010 or the distal segment 1011, and may comprise the cut pattern for the entire tube frame 1005. Each zone includes a plurality of units (or groups) of radially symmetric notch segments that are distributed around the circumference of the tube in bands or rows. The bands or rows may have from 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300 to n units. FIG. 8a shows seven zones ​​​​​​​​​ , i.e., zones 1 through 7 are shown. Units from each of the seven zones are They are identified as follows: (i) Zone 1, 8001; (ii) Zone 2, 8002; (iii) Zone 3, 8003; (iv) Zone 4, 8004; (v) Zone 5, 8005 (vi) Zone 6, 8006; and (vii) Zone 7, 8007. The unit is made up of three segments each with three notches extending radially from a central point or center of symmetry. The cutout segments may have three-fold rotational symmetry, and each cutout The segments are rotated 120 degrees from the adjacent notched segments about their centers of symmetry. Within a zone, all units of the notched segment have equal open surface area (i.e. The open surface area is the area enclosed by the contours of the segments in a continuous manner. The length of the continuous line may follow the shape of the notch segment. Across different zones, the units of notch segments are numbered according to the increasing zone number in the figure. When marked with a number, the surface area increases within the zone and the cut pattern perimeter may increase, for example, the ranking of open surface area may be: Zone 1 units < Zone 2 units < Zone 3 Units < Zone 4 Units < Zone 5 Units < Zone 6 Units < The units in Zone 7 are ranked by the cut pattern perimeter as follows: Units in Zone 1 < Units in Zone Zone 2 Units < Zone 3 Units < Zone 4 Units < Zone 5 Units < Zone The units in zone 6 are < the units in zone 7. As shown, the center of symmetry (center of symmetry A pattern of cutout portions having three-fold rotational symmetry around the This may be referred to as a "triad" pattern or a "triad" cut.

[0066] The configuration shown provides a non-uniform notch surface area range that gradually decreases along the length of the tube from zone 1 to zone 7, thereby enabling the segments of the tube shown in this embodiment to have a gradually increasing bending flexibility. The seven zones in FIG. 8a are shown arranged in order, i.e., from 1 to 7, for illustrative purposes only. In other embodiments, the zones containing the units can be arranged in any order along the longitudinal axis to provide any desired variation in bending flexibility at any point or section along the longitudinal axis. The tube can further be provided with fewer, 1, 2, 3, 4, 5, or 6, or more zones, 7, 8, 9, 10, 11, 12, 13, 14, or 15 (even more numbers, e.g., 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 up to n different zones are also possible). Zones having different notch surface areas and different notch pattern perimeters, e.g., zone 1, zone 6, zone 7, zone 4, zone 5, zone 3, zone 2, can also be arranged in any order to control the flexibility of the tube at any point along the length of the tube. The spacing between units within a band is shown in FIG. 8b and is represented as dc, where dc is the distance between the centers of symmetry Cs of two adjacent units within the same band. The spacing dc is equal within a single band and can be constant over the length of the tube in different zones. The spacing between bands within a zone, e.g., zone 1, zone 2, and zone 3, is d1, d2, and d along the longitudinal axis, and can be arranged in any order to provide any desired change in bending flexibility at any point or section along the longitudinal axis. The tube can further be provided with fewer, 1, 2, 3, 4, 5, or 6, or more zones, 7, 8, 9, 10, 11, 12, 13, 14, or 15 (even more numbers, e.g., 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 up to n different zones are also possible). Zones having different notch surface areas and different notch pattern perimeters, e.g., zone 1, zone 6, zone 7, zone 4, zone 5, zone 3, zone 2, can also be arranged in any order to control the flexibility of the tube at any point along the length of the tube. 3, respectively, and can be equal or different from each other. The distance between adjacent bands within a zone, e.g., the distance between the band in zone 1 and the band in zone 2, can be the same or different from the distance between the band in zone 2 and the band in zone 3. The distance between adjacent bands within a zone, e.g., the distance between the band in zone 1 and the band in zone 2, can be the same or different from the distance between the band in zone 2 and the band in zone 3. The distance between adjacent bands within a zone, e.g., the distance between the band in zone 1 and the band in zone 2, can be the same or different from the distance between the band in zone 2 and the band in zone 3. The distance between adjacent bands within a zone, e.g., the distance between the band in zone 1 and the band in zone 2, can be the same or different from the distance between the band in zone 2 and the band in zone 3. The distance between adjacent bands within a zone, e.g., the distance between the band in zone 1 and the band in zone 2, can be the same or different from the distance between the band in zone 2 and the band in zone 3. The distance between adjacent bands within a zone, e.g., the distance between the band in zone 1 and the band in zone 2, can be the same or different from the distance between the band in zone 2 and the band in zone 3.

[0067] The spacing between units within a band is shown in FIG. 8b and is represented as dc, where dc is the distance between the centers of symmetry Cs of two adjacent units within the same band. The spacing dc is equal within a single band and can be constant over the length of the tube in different zones. The spacing between bands within a zone, e.g., zone 1, zone 2, and zone 3, is d1, d2, and d 3, respectively, and can be equal or different from each other. The distance between adjacent bands within a zone, e.g., the distance between the band in zone 1 and the band in zone 2, can be the same or different from the distance between the band in zone 2 and the band in zone 3. 3, respectively, and can be equal or different from each other. The distance between adjacent bands within a zone, e.g., the distance between the band in zone 1 and the band in zone 2, can be the same or different from the distance between the band in zone 2 and the band in zone 3. 3, respectively, and can be equal or different from each other. The distance between adjacent bands within a zone, e.g., the distance between the band in zone 1 and the band in zone 2, can be the same or different from the distance between the band in zone 2 and the band in zone 3. shown as 3, d1 = d2 = d3, and the spacing is the center of symmetry Cs of the bands within each zone measured between the lines passing through. The spacing between zones, for example, zone 1 - zone 2 is d12, the zone 2 - zone 3 is shown as d23 and zone 3 - zone 4 is d34, and d12 = d 23 = d34, and the spacing is measured between lines 81 - 86. In one embodiment, the spacing between bands within a zone may be equal to the spacing between two bands between two different zones, for example, d1 = d2 = d3 = d12 = d23 = d34. In other embodiments, the spacing between bands within a zone may be greater than or less than the spacing between bands within two different zones, for example, d1 = d2 = d3 > d12 = d23 = d34 or d1 = d2 = d3 < d12 = d23 = d34.

[0068] Any notch segments of the units within a zone can have the same direction or be in - phase with respect to the line passing through the center of symmetry of each row. Adjacent bands within a zone or notch segments within a row can also have the same direction or be in - phase with respect to the line passing through the center of symmetry of each row. In other words, the corresponding notch segments within one unit within a zone are parallel to the notch segments within adjacent units The centers of symmetry Cs of the units within adjacent bands within the same zone are shifted by only one unit as shown An overview of the transition of units from zone 1 to zone 7 is shown in Fig. 8c. The following characteristics apply to the dimensions of the entire zone. The open surface area of the notch regions across different zone sequences such as zone 1 < zone 2 < zone 3 < zone 4 < zone 5 < zone 6 < zone 7. The change in the open surface area or the perimeter length of the cut - in pattern across multiple zones can be linear, exponential as shown in Fig. 8c. The following characteristics apply to the dimensions of the entire zone. The open surface area of the notch regions across different zone sequences such as zone 1 < zone 2 < zone 3 < zone 4 < zone 5 < zone 6 < zone 7. The change in the open surface area or the perimeter length of the cut - in pattern across multiple zones can be linear, exponential or logarithmic. Yes, it is a step or square wave function, and it can be increasing, decreasing, constant, continuous or discontinuous.

[0069] Within any one zone, the notch segments forming the unit can take on any symmetric shape with respect to the center of symmetry Cs. The unit can have 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or n notch segments. The notch segments can be continuous or separate from each other. For example, the notch segments can form a circle, or a symmetric n-sided polygon such as a hexagon or octagon. Different zones can have the same or different symmetric shapes . In these embodiments, the geometric rules within and across the zones remain the same as in the case of the above three sets of notch segments. Specifically, the units are arranged within the band . The band or row can have 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 1000 or n units. The spacing between the units within the band is denoted as dc, which is the distance dc between the centers of symmetry Cs of two adjacent units within the band, and can be equal within a single band and constant over the length of the tubes in different zones. The spacing between the bands within and across the zones can be equally the same. All the notch segments of the units within the zone can have the same direction or be in phase with respect to the line passing through the center of symmetry of each row or band. The notch segments within adjacent bands or rows within the zone can also have the same direction or be in phase with respect to the line passing through the center of symmetry of each row. The centers of symmetry Cs of the units within adjacent bands within the same zone are shifted. The units are in two adjacent zones . . . . . . . Among them, a straight line can be drawn between the centers of symmetry of the units in adjacent zones, and it moves around the circumference of the band. The centers of symmetry Cs in different bands are along the same line every other band. In other words, the center of symmetry of each unit is the same as that of the second unit in bands such as the third, fifth, etc., which are separated from the first band by only one band, and is arranged at a point on the circumference of the tube frame.

[0070] One tube frame 1005 can include a plurality of different zones. For example, the tube can be provided with 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 pieces (even more numbers, for example, 20, 30, 40, 50, 60, 7 0, 80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 to n different zones are also possible). When the tube frame 5 includes a plurality of zones, the open surface area and the perimeter of the cut pattern can vary across different zones. For example, when the notch segments are formed in a hexagonal shape and there are seven zones, i.e., the first zone, the second zone, the third zone, the fourth zone, the fifth zone, the sixth zone and the seventh zone, the sequence of the open surface area and the perimeter of the cut pattern is: unit of the first zone < unit of the second zone < unit of the third zone < unit of the fourth zone < unit of the fifth zone < unit of the sixth zone. When the number of units per zone is equal, the sequence also applies to the zones. The variation of the open surface area or the perimeter of the cut pattern across a plurality of different zones can be linear, exponential ... be numerical, stepwise or square-wave functions, increasing, decreasing or constant and may be continuous or discontinuous.

[0071] In embodiments formed from other notch segments, e.g., circles, or n-sided polygons the width across any non-notch portion may vary, i.e., the width may decrease. This decrease in width results in an increase in the open surface area 1004. By increasing the open surface area, the non-notch surface area, within a unit in any one zone the flexibility of that portion of the notch segment composed of such units that have an increased open surface area is increased.

[0072] The flexibility of the tube frame 1005 can be controlled at any position along the tube frame 1005 by combining one or more zones at various positions along the length of the tube. The flexibility of the tube frame 1005 is positively correlated with the open surface area. In other words as the open surface area of the notch segment increases, the flexibility of the zones composed of units with larger notch segments increases. Conversely, the flexibility is inversely correlated with the non-notch region and as the non-notch surface area increases, the flexibility decreases.

[0073] The total non-notch region at any one point on the tube frame 1005 depends on many factors including the number of bands within each zone and the dimensions of the notch segments (open surface area of a particular unit). When the number of bands within each zone is constant, the ranking with respect to non-notch surface area is unit of zone 1 > unit of zone 2 > unit of zone 3 > unit of zone 4 > unit of zone 5 > unit of zone 6 > unit of zone 7 (in other words zone ​​​across the non-cutting region disappears), the flexibility sequence of the tube is Zone 1 < Zone 2 < Zone 3 < Zone 4 < Zone 5 < Zone 6 < Zone 7 (flexibility is positively correlated with the open surface area and negatively correlated with the non-cutting region). The change in flexibility across multiple different zones can be linear, exponential, stepwise or square wave function, increasing, decreasing, constant, discontinuous or continuous.

[0074] By using different zone patterns along the length of the shaft, the flexibility can be increased or decreased along the length of the shaft, and other characteristics of the tube, such as torque, flexibility, pushability, resistance to axial compression and elongation, maintenance of lumen diameter, and kink resistance can also be increased or decreased. According to an embodiment of the present disclosure, the tube frame 1005 can include a plurality of different cutting patterns along its length that provide various degrees of rigidity. For example, as shown in FIG. 9a, the tube frame 1005 has a first section 9001 with intermittent or discontinuous spiral cuts where non-cutting sections are interspersed, providing an average rigidity of 0.002 to 0. 004 N / mm for that section, and having a rigidity of 0.003 N / mm in a preferred embodiment; a second section 9002 including the continuous spiral pattern described above, providing an average rigidity of 0.001 to 0.003 N / mm for that section, and having a rigidity of 0.002 N / mm in a preferred embodiment; and one or more of the zones and patterns described above shown in FIGS. 8a - 8c.

[0075] According to an embodiment of the present disclosure, the tube frame 1005 can include a plurality of different cutting patterns along its length that provide various degrees of rigidity. For example, as shown in FIG. 9a, the tube frame 1005 has a first section 9001 with intermittent or discontinuous spiral cuts where non-cutting sections are interspersed, providing an average rigidity of 0.002 to 0. 004 N / mm for that section, and having a rigidity of 0.003 N / mm in a preferred embodiment; a second section 9002 including the continuous spiral pattern described above, providing an average rigidity of 0.001 to 0.003 N / mm for that section, and having a rigidity of 0.002 N / mm in a preferred embodiment; and one or more of the zones and patterns described above shown in FIGS. 8a - 8c. 004 N / mm for that section, and having a rigidity of 0.003 N / mm in a preferred embodiment; a second section 9002 including the continuous spiral pattern described above, providing an average rigidity of 0.001 to 0.003 N / mm for that section, and having a rigidity of 0.002 N / mm in a preferred embodiment; and one or more of the zones and patterns described above shown in FIGS. 8a - 8c. 004 N / mm for that section, and having a rigidity of 0.003 N / mm in a preferred embodiment; a second section 9002 including the continuous spiral pattern described above, providing an average rigidity of 0.001 to 0.003 N / mm for that section, and having a rigidity of 0.002 N / mm in a preferred embodiment; and one or more of the zones and patterns described above shown in FIGS. 8a - 8c. N / mm of rigidity; a second section 9002 including the continuous spiral pattern described above, providing an average rigidity of 0.001 to 0.003 N / mm for that section, and having a rigidity of 0.002 N / mm in a preferred embodiment; and one or more of the zones and patterns described above shown in FIGS. 8a - 8c. section, and having a rigidity of 0.002 N / mm in a preferred embodiment; and one or more of the zones and patterns described above shown in FIGS. 8a - 8c. section, and having a rigidity of 0.002 N / mm in a preferred embodiment; and one or more of the zones and patterns described above shown in FIGS. 8a - 8c. section, and having a rigidity of 0.002 N / mm in a preferred embodiment; and one or more of the zones and patterns described above shown in FIGS. 8a - 8c. A third section 9003 including the above, providing an average stiffness of the section of 0.002 to 0.004 N / mm, and having a stiffness of 0.003 N / mm in a preferred embodiment. It includes the third section 9003. The tube frame 1005 may further include a section 9004, which may include a plurality of interconnected rings described herein, thereby providing an average stiffness of the section of 0.005 to 0.016 N / mm. The helical cut section may include several subsections having different helical parameters such as cut width, gap, pitch, etc., so that the flexural flexibility along the helical cut section can vary longitudinally as desired. In the tube frame 1005, any combination of the cut patterns described herein may be used. Here, referring to the example shown in FIG. 9b, the tube frame 1005 may also include one or more solid non-cut sections 9005a, 9005b extending along the length of the tube frame 1005. The non-cut sections 9005a, 9005b may be arranged between two different (or the same) cut patterns including intermittent helical cut sections 9001a - c, and / or may be interspersed between one or more segments having a helical cut, interconnected rings or other patterns, such as those shown in FIG. 9a or described herein. The tube frame 1005 can be connected to the pressing member 1001 in various different ways. For example, as shown in FIGS. 10a - b, the tube frame 1005 is...

[0076] Here, referring to the example shown in FIG. 9b, the tube frame 1005 may also include one or more solid non-cut sections 9005a, 9005b extending along the length of the tube frame 1005. The non-cut sections 9005a, 9005b may be arranged between two different (or the same) cut patterns including intermittent helical cut sections 9001a - c, and / or may be interspersed between one or more segments having a helical cut, interconnected rings or other patterns, such as those shown in FIG. 9a or described herein. The tube frame 1005 can be connected to the pressing member 1001 in various different ways. For example, as shown in FIGS. 10a - b, the tube frame 1005 is... The tube frame 1005 can be connected to the pressing member 1001 in various different ways. For example, as shown in FIGS. 10a - b, the tube frame 1005 is... The tube frame 1005 can be connected to the pressing member 1001 in various different ways.

[0077] The tube frame 1005 can be connected to the pressing member 1001 in various different ways. For example, as shown in FIGS. 10a - b, the tube frame 1005 is... It may define or include a tongue element 1017 extending proximally from the proximal segment of 005. The tongue element 1017 may be integral with the tube frame 1005 and formed from the same material composition . While the distal end or region of the tongue piece 1103 may be disposed distally relative to the proximal opening of the tube frame 1005 / lumen 100 8, the proximal end or proximal region 1105 of the tongue element 1005 extends proximally beyond the proximal opening of the tube frame 1005 . FIG. 10b. The tongue element 1017 may be longitudinally recessed or offset along the tube frame 1005 relative to the proximal opening of the lumen 1008. One or more notches or spaces 1101 adjacent to the tongue element 1005 may be included in the tongue element 1017 and / or proximal segment 1010 of the tube frame 1005 to allow the tongue element 100 5 to pivot to some extent relative to the remainder of the tube frame 1005 and / or be cantilever supported. FIGS. 10a - b. The notch or space 1101 may connect to or otherwise include one or more keyholes 1102 to facilitate such cantilever supported movement and reduce the risk of material breakage at the deflection point of the tongue piece . FIG. 10b . Thus, such cantilever supported or pivoting movement is oriented around the recessed distal end of the tongue element 1017 that may be supported by other components described herein, reducing the likelihood of material fatigue and / or cyclic load failure of the tongue element 1017 during use of the guide catheter extension . . . . .

[0078] The distal region 1103 on the tongue element 1017 may take on a variety of different shapes. In one embodiment , the distal region 1103 is generally trapezoidal in shape. FIG. 11a. In this embodiment, the notch or ​The space 1101 is angled with respect to the longitudinal axis LA1009 of the tube frame 1005 and is set. An embodiment in which the distal region 1003 is substantially rectangular is shown in FIG. 10b . In this embodiment, the notch 1101 is shown to be generally parallel to the longitudinal axis L A1009 of the tube frame 1005. In a third embodiment, the distal region 1103 of the tongue element 101 7 is in the same plane as the proximal end 1012 of the tube frame 1005 . FIG. 11b.

[0079] The tongue element 1017 may be angled with respect to the longitudinal axis LA1009 . FIG. 12. For example, as shown in FIG. 12, the tongue 14 extends toward the inner wall 103 of the surrounding guide catheter "GC"( 1201), thereby reducing any occlusion or cross-sectional obstruction that the tongue element 1017 may impose on a more proximal region of the tube frame 1017 where additional devices, instruments, etc. may be disposed . The deflection angle θ12 02 of the tongue element 1017 can vary to correspond to a particular application and / or the dimensions of the guide catheter . In one example, the angle between the tongue element 1017 and the longitudinal axis LA1009 can be about 10 degrees . Other embodiments of the deflection angle can be in the range of about 5 degrees to 35 degrees .

[0080] The tongue element 1017 can be sized and / or shaped to fitingly connect with a part of the pushing member 1001 . For example, as shown in FIGS. 13a - b, the tongue element 1017 can have a substantially rectangular cross-section 130 1 disposed within a slot of corresponding shape in the pushing member 1001 . The slot in the pushing member 1001 constitutes, for example, a part of the pushing member 1001 Flattening the portion 1301 of the generally substantially rounded tube 1302, which is normally done can be formed. To connect the tube frame 1005 to the pressing member 1001 other shapes and cross-sectional profiles may be implemented, and the connection can be achieved and / or fixed by any joining method including crimping, caulking, staking, adhesive bonding, welding, brazing and / or soldering and / or fixed.

[0081] Referring now to FIG. 14, another example of the interconnection between the tube frame 1055 and the pressing member 1001 is shown. In this example, an intermediate connecting member such as a wire, a shim, a rod, etc., 1401 is connected to the tongue element 1402 of the tube frame 1005 and extends proximally to connect to the pressing member 1001. In this example, the intermediate connecting member 1401 may slide over or otherwise be attached to the tongue 1402 which may have a length shorter than that of the tongue element 1017 The intermediate connecting member 1401 is connected in a fitting manner (1403) to the pressing member 1001 at the opposite end

[0082] In another example, the intermediate connecting member 1401 may be connected to or disposed within an aperture or opening 1501 defined by the tube frame 1005. For example, as shown in FIG. 15 the tube frame 1005 defines a keyhole opening 1 501 instead of the tongue element 1017, and the intermediate connecting member 1401 is disposed within the keyhole opening 1501. The keyhole opening 1501 within the tube frame 1005 may have various shapes and sizes to accommodate the intermediate connecting member 1401 and facilitate the connection thereto. For example, FIG. 16 shows an example of a substantially rectangular opening 1603. The intermediate connecting member 1401 is an adhesive ​​​​, welding, fusing, or other joining modes 1601, 1602 can be applied to be fixed at a predetermined position . Referring to FIG. 17 here, in addition to and / or instead of such connection , one or more applications of an adhesive, welding, fusing, or other joining mode can be reused between the cap 1702, the intermediate connecting member 1401, and the tube frame 1005 to place the cap 1702 on a part of the intermediate connecting member 14 01 and enclose and fix the intermediate connecting member 1401 to the tube frame 1005 .

[0083] In another example, the pushing member 1001 can be directly connected to an aperture or opening defined by the tube frame 5, such as that shown in FIGS. 16-17. In another embodiment , the pushing member 1001 can define an elongated portion or segment 1801 that directly connects to an aperture or opening defined by the tube frame 1005. Then , the pushing member 1001 can be directly fixed to the tube frame 1005 by using one or more applications of an adhesive, welding, fusing, or other joining mode .

[0084] In another example, as shown in FIGS. 19a-b, the length of the pushing member 1001 can overlap the length of the tongue element 101 7 and / or the intermediate connecting member 1401 to increase the surface area between the two components for bonding or other attachment . The pushing member 1001 can further define or include a shaving portion 1901 that receives the tapered portion or cut portion 1902 of the tongue element 101 7 and / or the intermediate connecting member 1401. In an alternative example, as shown in FIGS. 1a and 23a , the pushing member 1001 overlaps the tongue element 1017 and is joined via an adhesive or welding 105 0 to fix the components together .​

[0085] Referring now to FIGS. 20a - b, wire 2100 is coupled to each of push member 1001 and tongue element 1017 and / or intermediate coupling member 1401, overlapping to enhance the stability and strength of the attached assembly. Wire 2100 may be joined or otherwise coupled to each of push member 1001 and tongue element 1017 and / or intermediate coupling member 1401 by welding, adhesive, or other manufacturing processes. Tongue element 1017 and / or intermediate coupling member 1401 may also include an internal cavity, or a notch or tapered section 2101 extending into an opening of the push member. FIG. 20c.

[0086] Another example of the interconnection between tube frame 1005 and push member 1001 is shown in FIGS. 21a - d. In this example, push member 1001 includes keyhole 2102, and keyhole 2102 is sized or shaped to receive a corresponding complementary keyhole cutout region 2103 of tongue element 1017 and / or intermediate coupling member 1401, and the length of push member 1001 is overlapped with the length of tongue element 1017 and / or intermediate coupling member 1401 to increase the surface area between components for bonding or other attachment.

[0087] The portions of tongue element 1017, intermediate coupling member 1401, and / or push member 1001 coupled to tube frame 1005 may include one or more features, dimensions, shapes, and / or contours to facilitate flexibility in one or more planes of motion, thereby improving the overall flexibility of the guide extension catheter and / or contributing thereto. ​​​​​​​​​​​​​​and / or one or more notches, slots for providing flexure or bending in the vertical direction Examples of such features that include or are curved portions are shown in FIGS. 21c-d. Such other implementations or combinations of features may be used to provide the desired degree or range of bending .

[0088] The tube frame 1005 can provide or facilitate the attachment of one or more components or layer materials, as further described herein. The distal end 1013 and / or proximal end 1012 of the tube frame 100 5 may include one or more axially oriented protrusions 1019 extending therefrom. FIGS. 22a-f. In certain embodiments, the protrusions 1019 may be generally parallel to the longitudinal axis LA1009 of the tube frame 1005. Alternatively, the distal end 1012 and / or proximal end 1013 of the tube frame 1005 may be in the same plane or flat, i.e., perpendicular to the longitudinal axis 1009. FIG. 22 a. For example, the protrusions 1019 may be made of a plurality of closed curvilinear elements that can be sinusoidal or generally wavy (serpentine) in shape. FIG. 22a . The protrusions 1019 may be laser cut directly from the wall of the tube frame 1005 or manufactured by other means

[0089] or assembled or connected to the tube frame 1005 such that the protrusions 1019 share the same inner diameter 2201 and outer diameter 2202 dimensions (the inner dimension 2203 of the lumen 1008 and the outer dimension 2204 of the tube frame 1005). For example, as shown in FIGS. 22a-b, the protrusions 1019 may be a crown-shaped configuration that substantially surrounds the end or opening into the lumen of the tube frame 1005 . frame 1005 It may include a plurality of curved convex portions. Each of the curved protrusions may include an internal aperture or an opening mouth portion 2205 therein. FIGS. 22a - b.

[0090] In another example, each of the protrusions 1019 may include a substantially keyhole - shaped shape as shown in FIGS. 22c - d. The keyhole protrusions 1019 generally may include a substantially rectangular portion connected to a substantially circular or curved portion at its end, and the substantially circular or curved portion has a diameter larger than the width of the substantially rectangular portion.

[0091] In another example, each of the protrusions 1019 may include a substantially rounded rectangular shape as shown in FIGS. 22e - f. The protrusions 1019 generally may include a substantially rectangular portion connected to a substantially semi - circular or curved portion at its end, and the substantially semi - circular or curved portion has a diameter substantially the same as the width of the substantially rectangular portion.

[0092] The proximal end 1012 of the tube frame 1005 may include a flare or flange 1018 (FIG. 1b). The flare or flange 1019 can be used to close or reduce the gap between the tube frames 1005 of the guide catheter 1201. FIG. 23a. The guide catheter (GC) 1201 surrounds the guide catheter extension and provides an inclined surface for guiding wires, instruments and / or other devices that can be inserted and routed through the guide catheter extension (such as a treatment catheter or a stent delivery device) to the proximal opening 2 302 and into the lumen 1008 of the tube frame 1005. Thus, the flare 1019 is along the longitudinal axis LA1009 of the tube frame 1005 and may be substantially coaxial with the lumen 1008 therethrough, and the tube frame 100 may extend proximally from the proximal end 1012 to the distal end 1013 of 1005. In the illustrated embodiment, a flare or flange 1018 extends radially outwardly from the proximal opening 2302 of the tube frame 1005 and the lumen 1008 and has an outer diameter that is larger than the outer diameter of the tube frame 1005. A flare or flange 1019 substantially closes or seals any gap 2301 formed between the guide catheter 1201 and the tube frame 1005. The cross-sectional area of the flare or flange 1018 may taper or thin at a point on the flare 2303 that is not attached to the axial protrusion 1021. Functionally, this section of the flare or flange 2305 can function as a "wiper blade" that can contact the guide catheter 1201. From the region in contact with the axial protrusion to the region not in contact, the cross-sectional area of the flare or flange 1018 across this decrease in the flare or flange 1018 in the region or section 2305 not in contact with the axial protrusion increases the flexibility or ability to bend the flare or flange 1018. This flexibility allows the flare or flange 1018 to accommodate catheters of different diameters while maintaining a seal between the guide catheter 1201 and the tube frame 1005. For example, this type of structure uses a guide catheter extension to inject a contrast agent into a target site in a patient's vascular system without leakage from the distal end of the guide catheter extension, and to facilitate efficient aspiration through the lumen 1008 of the tube frame 1005 rather than through the gap interval or gap between the tube frame 1005 and the guide catheter 1201. ​​​​​​​​ Enable it to do so.

[0093] The flare or flange 1018 is made of one or more elastic polymer materials, preferably a rubber material with good lubricity, such as PEBA, PTFE, silicone or other fluoropolymers. The flare or flange 1018 can also be radiopaque, which can be achieved by using tungsten-filled polymers such as PBAX® or bis mass-filled polymers. The thickness of the flare or flange 1018 is such that the flare or flange 1018 allows the guide catheter extension to move axially within the guide catheter 1201 without significantly interfering with its operability. It can be selected to ensure that it has sufficient flexibility. For example, the thickness of the flare 120 can be about 0.05 mm (0.0019 inches) to about 1 mm (0.039 inches or about 0.2 mm (0.0078 inches) to about 0.5 mm (0.0196 inches). The flare or flange 1018 is made as a separate component and can be adhered to the proximal end 1012 of the tube frame 1005, including the adhesion or connection of the flare or flange 1018 to the protrusion 1019 (as shown in FIGS. 1a - c). In such an example, the flare or flange 1018 can be fused or melted onto the protrusion 1019, and the protrusion 1019 can resist the axial separation of the flare or flange 1018 through the shape and / or aperture / openings characteristics of the protrusion 1019. Alternatively, the flare or flange 1018 can be constructed as an extension of the inner lining or outer jacket of the guide catheter 1201.

[0094] The flare or flange 1018 is made as a separate component and can be adhered to the proximal end 1012 of the tube frame 1005, including the adhesion or connection of the flare or flange 1018 to the protrusion 1019 (as shown in FIGS. 1a - c). In such an example, the flare or flange 1018 can be fused or melted onto the protrusion 1019, and the protrusion 1019 can resist the axial separation of the flare or flange 1018 through the shape and / or aperture / openings characteristics of the protrusion 1019. In an alternative example, the flare or flange 1018 can be constructed as an extension of the inner lining or outer jacket of the guide catheter 1201. In such an example, the flare or flange 1018 can be fused or melted onto the protrusion 1019, and the protrusion 1019 can resist the axial separation of the flare or flange 1018 through the shape and / or aperture / openings characteristics of the protrusion 1019. In an alternative example, the flare or flange 1018 can be constructed as an extension of the inner lining or outer jacket of the guide catheter 1201. In an alternative example, the flare or flange 1018 can be constructed as an extension of the inner lining or outer jacket of the guide catheter 1201. lining or outer jacket of the guide catheter 1201. ​​can be formed. The end of the flare or flange 1018 can be substantially perpendicular or perpendicular to the longitudinal axis LA1008 of the tube frame 1005, i.e., it is not in a shaved configuration. For example, see Figure 1b.

[0095] The flare or flange 1018 is partially fused to the tongue element 1017 and / or the intermediate connecting member 14 01, and / or a part of the flare or flange is disposed relative to the lower side of the tongue element 1017 and / or the intermediate connecting member 1401 so as to further provide structural support to the tongue element 1017 and / or the intermediate connecting member 1401. Accordingly, the flare or flange 1018 can support or suppress excessive flexure and / or material breakage of the tongue element 1017 and / or the intermediate connecting member 1401 when the guide catheter is in use.

[0096] The flare or flange 1018 can include a substantially uniform circumferential profile. Using alternative shapes and profiles of the flare or flange 1018 can facilitate both sealing the catheter to the inner wall of the external guide catheter and assisting in receiving the guide wire into the lumen of the distal tube. For example, as shown in Figure 24, the flare or flange 1018 can have an asymmetric protruding section 2501 that extends further outwardly from the rest of the flare or flange 1018. The protruding section can be disposed at the "top" of the device (e.g., substantially opposite the tongue element 1017 or the intermediate connecting member 1401). Figure 24. Figures 25a - c show two protruding sections 2601 opposite each other. ​​​​​Another example of a flare or flange 1018 disposed thereagainst is shown. FIGS. 26a -b show another example of a flare or flange 1018 in which four protruding sections 2701 are disposed approximately equidistantly from each other around the circumference of the flare. Another example of a flare or flange 1018 is shown. FIGS. 27a-c show a flare or flange 1018 in which a plurality of protruding sections 2801 are disposed around the circumference of the flare or flange 1018. Another example of a flare or flange 1018 is shown. In one embodiment, these protruding sections 2801 are formed from the same material as the tube frame 1005 by cutting a plurality of protruding sections 2901. Then

[0097] the flare or flange 1018 can surround the plurality of protruding sections 2901. FIGS. 28a-b. As described above, the flare or flange 1018 assists in guiding the guide wire 3001 and / or other instruments or devices that have passed through the external guiding catheter into the lumen 1008 of the tube frame 1 005. For example, as shown in FIGS. 29a-c, a guide wire (GW) 3001 can be advanced through the proximal portion of the guide catheter (GC) 3001 toward the tube frame 1005 of the guide catheter extension. When the guide wire 122 contacts the flare or flange 1018, if the guide wire 122 is off-center or otherwise meandering through the lumen 100

[0098] 8 of the guide catheter (GC) 1201, the shape and flexibility of the flare or flange 1018, as shown in FIGS. 29a-d, can direct the guide wire 3001 into the tube frame without damaging it. 005. For example, as shown in FIGS. 29a-c, a guide wire (GW) 3001 can be advanced through the proximal portion of the guide catheter (GC) 3001 toward the tube frame 1005 of the guide catheter extension. When the guide wire 122 contacts the flare or flange 1018, if the guide wire 122 is off-center or otherwise meandering through the lumen 100 8 of the guide catheter (GC) 1201, the shape and flexibility of the flare or flange 1018, as shown in FIGS. 29a-d, can direct the guide wire 3001 into the tube frame without damaging it. 8 of the guide catheter (GC) 1201, the shape and flexibility of the flare or flange 1018, as shown in FIGS. 29a-d, can direct the guide wire 3001 into the tube frame without damaging it. Advance a guide wire (GW) 3001 into the lumen 1008 of 1005. The guide wire ( GW) 3001, upon passing through the starting point of the lumen 1008, is pushed through the remaining portion of the tube frame 1005 towards the distal end 1013 of the tube frame 1005 and is pushed out towards the anatomical structure to be traversed. FIGS. 29a - d.

[0099] The guide wire is typically relatively thin and has a diameter of about 0.254 mm to 0.457 mm. The guide wire (GW) can transmit rotation from the proximal end of the guide wire to the distal end of the guide wire. This transmission enables a physician to controllably maneuver the guide wire through the bifurcations of a patient's artery and manipulate a catheter to a target site of interest within the coronary artery. Further, the distal end of the guide wire should be flexible enough to enable the distal portion of the guide wire to pass through a sharply curved and serpentine coronary anatomical structure.

[0100] Guide wires are well known in the art, and the appropriate selection of a guide wire for use with the disclosed catheter can be made by a medical professional such as an interventional cardiologist or an interventional radiologist. Among the common guide wire (GW) configurations used in angioplasty is a guide wire of the type shown in U.S. Patent No. 4,545,390. Such a wire includes an elongated flexible shaft, typically formed of stainless steel, having a tapered distal portion and a helical coil attached around the tapered distal portion. The generally tapered distal portion of the shaft acts as a core for the coil and enables a physician to controllably maneuver the guide wire (GW) through a patient's blood vessels in accordance with the anatomical structure of the vessels. ​ While following the contour of , still transmit rotation from the proximal end to the distal end of the guide wire There is also a guide wire (GW) with increased flexibility at the distal part, adapted to be able to The characteristics of the guide wire are significantly affected by the details of the structure as the distal tip of the guide wire For example, in a certain type of tip structure, the tapered core wire extends completely through the helical coil to the distal tip of the coil and can be directly attached to the smoothly rounded tip weld at the distal tip of the coil Such a structure typically results in a relatively rigid tip that is particularly suitable for use when attempting to push the guide wire through a narrow region of stenosis In addition to high column strength, such a tip also exhibits excellent torsional characteristics Liner 3101 may include one or more polymers arranged in layers to form a tube For example, liner 3101 may form a tube containing two different materials 3102, 3103, each having a different crystal melt or melting temperature

[0101] Liner 3101 may be constructed from one or more polymers. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene Liner 3101 may be constructed from one or more polymers. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene Liner 3101 may form a tube containing two different materials 3102, 3103, each having a different crystal melt or melting temperature Liner 3101 may be constructed from one or more polymers. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene Liner 3101 may be constructed from one or more polymers. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene Liner 3101 may be constructed from one or more polymers. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene Liner 3101 may be constructed from one or more polymers. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene Liner 3101 may be constructed from one or more polymers. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene Liner 3101 may be constructed from one or more polymers. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene Liner 3101 may be constructed from one or more polymers. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / Poly(alkylene ether) phthalate and / or other polyester elastomers , for example, HYTREL available from DuPont, polyamide (e.g., DURETHAN available from Baye r or CRI STAMID. available from Elf Atochem), elastomeric polyamide, block polyamide / ether, poly ether block amide (PEBA, e.g., available under the trade name PEBAX), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., , REXELL), polyester, polybutylene terephthalate (PBT), polyethy lene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphtha late (PEN), polyetheretherketone (PEEK), polyimide (PI), poly etherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide ( PPO), polyparaphenylene terephthalamide (e.g., KEVLAR), polysulfo ne, nylon, nylon-12 (such as GRILAMID available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethy lene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomer, biocompatible polymer , other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites such as may be mentioned. In some examples, liner 3101 is a liquid crystal polymer (LCP ) can be blended with

[0102] For example, as shown in FIG. 30, the liner 3101 is disposed within the lumen 1008 of the tube frame 1005, extends from the proximal end 1012 of the tube frame 1005, and is adjacent to and / or connected to the flange 1018 and / or the axial protrusion 1019, and can descend to and / or pass through the distal end 1013 of the tube frame 1005. As shown, the liner 3101 can have an overall length longer than the length of the tube frame 1005 such that a portion of the liner 3101 extends beyond and from the distal end of the tube frame 5. The liner can form a tube 3103 within the tube frame 1005. As shown, the liner 3101 can have an overall length longer than the length of the tube frame 1005 such that a portion of the liner 3101 extends beyond and from the distal end of the tube frame 5. The liner can form a tube 3103 within the tube frame 1005. The liner 3101 can contribute to the operability of the entire tube frame 1005 and the guide catheter 1201 for moving a serpentine anatomical structure with a reduced radius of curvature, while (and / or without significantly interfering with them) complementing the pushability of the guide catheter extension both internally and partially externally. To achieve such performance, the liner 3101 can be constructed from the above materials and can include a wall thickness of from about 0.0635 mm (0.00025 inches) to about 0.127 mm (0.005 inches). In a preferred example, the liner 3101 can be constructed from the above materials and can include a wall thickness of from about 0.0635 mm (0.00025 inches) to about 0.0127 mm (0.0005 inches).

[0103] The liner 3101 can contribute to the operability of the entire tube frame 1005 and the guide catheter 1201 for moving a serpentine anatomical structure with a reduced radius of curvature, while (and / or without significantly interfering with them) complementing the pushability of the guide catheter extension both internally and partially externally. To achieve such performance, the liner 3101 can be constructed from the above materials and can include a wall thickness of from about 0.0635 mm (0.00025 inches) to about 0.127 mm (0.005 inches). In a preferred example, the liner 3101 can be constructed from the above materials and can include a wall thickness of from about 0.0635 mm (0.00025 inches) to about 0.0127 mm (0.0005 inches). The liner 3101 can contribute to the operability of the entire tube frame 1005 and the guide catheter 1201 for moving a serpentine anatomical structure with a reduced radius of curvature, while (and / or without significantly interfering with them) complementing the pushability of the guide catheter extension both internally and partially externally. To achieve such performance, the liner 3101 can be constructed from the above materials and can include a wall thickness of from about 0.0635 mm (0.00025 inches) to about 0.127 mm (0.005 inches). In a preferred example, the liner 3101 can be constructed from the above materials and can include a wall thickness of from about 0.0635 mm (0.00025 inches) to about 0.0127 mm (0.0005 inches).

[0104] The liner 3103 is only partially and / or intermittently fused to the tube frame 5 or otherwise adhered, which may further contribute to the overall flexibility and pushability of the guide catheter. The attachment of the liner 3103 to the inner wall of the tube may include, for example, heat fusion / melting, use of adhesives, or other manufacturing processes. The bonding / attachment process may include one or more intermediate compounds or materials to facilitate or effect the attachment between the liner 3103 and the tube frame 1005. For example, in a device utilizing a liner constructed from PTFE, a PEBAX® powder coating may be applied between the PTFE liner and the distal tube. Then, heat may be applied to the tube frame 1005 assembly at a temperature sufficient to melt the PEBAX®, but lower than the temperature required to melt the PTFE. Thus, the melted PEBAX® bonds the PTFE liner to the tube frame 1005 and secures it in place. The fused segments of PEBAX® can be attached as rings or points. When the polymer liner is fully bonded to the tube frame 1005, the rigidity of the fused assembly significantly increases, and the flexibility decreases, at least in part due to the change in the hardness of the fused liner resulting from the bonding process. For example, FIG. 31 provides measurements obtained from a series of bending tests applied to the components and combinations of the tube frame 5 and the liner 3103 assembly. The Y-axis of the graph indicates the bending force required to bend the

[0105] subject assembly or component, and the X-axis indicates the position along the length of the subject assembly or component where the force is applied and measured. When the liner is fully fused, the tube frame 1005 is subjected to a three-point bending test by the The Y-axis of the graph indicates the bending force required to bend the subject assembly or component, and the X-axis indicates the position along the length of the subject assembly or component where the force is applied and measured. When the liner is fully fused, the tube frame 1005 is subjected to a three-point bending test by The bending test was performed in a similar setup to that shown in Figure 32. Using the measurement, for example, the length L of the tube frame 1005 is supported at two points, and then Apply a force F to the midpoint of the length of the The test fixture used to perform the measurements was Chatter The tester was an Illon® LTCM-6 digital motorized force tester.

[0106] As shown in the graph in Figure 31, a tube with no liner placed in or on it The frame 1005 requires approximately 0.22N to 0.35N to bend. The tube frame 1005 with the unfused liner disposed therein is bent. Approximately 0.335N to 0.469N is required to lift the partially bonded liner. The tube frame 1005 located within the Depending on the contact, it may take approximately 0.469N to 1.088N to bend (e.g., fusion point Relatively high bending forces are required near the fusion point, but the greater the distance from the fusion point, the less bending force is required. (The force that is considered to be the force is significantly lower.) The tube with the liner completely fused to the tube frame The frame 1005 requires approximately 1.1N to 1.405N to bend the assembly, which is This is nearly three times the bending force required for a partially fused assembly. As a result, the partially fused liner construction has several advantages over the conventional fully fused liner construction. It provides twice as much flexibility and maneuverable performance.

[0107] For example, the liner 3203 may be fused to the tube frame 1005. Use various patterns, intervals and / or (one or more) shapes of the foci or segments to fuse, bond and / or otherwise adhere intermittently or partially to the tube frame 5. Such patterns, intervals, dimensions and / or shapes can vary in conjunction with other variable features of the distal assembly such as material selection, wall thickness, notch pattern, etc., to provide the overall desired pushability and flexibility of the guide catheter extension. For example, the connection of the liner 3203 to the tube frame 1005 can include the creation or implementation of one or more fusion segments 3301 each having a substantially ring-shaped or circumferential profile as shown in FIG. 33a. Each substantially circumferentially fused segment 3203 can have a width of from about 1 mm (0.0393 inches) to about 2.54 cm (1 inch). Along the length of the distal assembly, a plurality of substantially circumferentially fused segments can be used, where successive substantially circumferentially fused segments are spaced from about 1 mm

[0108] (0.0393 inches) to about 2.54 cm (1 inch). FIGS. 33b-c. In another example, the liner 3203 can be connected to the tube frame 5 at three positions, namely, near the proximal end 10 and the distal end 11 of the tube frame 5 or near them, and at or near the approximate midpoint of the tube frame 5. In a preferred example, each fusion segment 3301 can have a width of from about 1 mm (0.0393 inches) to about 2 mm (0.0787 inches), and successive fusion segments can be spaced from about 12.7 mm (0.5 inches) or more apart. (0.0393 inches) to about 2.54 cm (1 inch). FIGS. 33b-c. In another example, the liner 3203 can be connected to the tube frame 5 at three positions, namely, near the proximal end 10 and the distal end 11 of the tube frame 5 or near them, and at or near the approximate midpoint of the tube frame 5. (0.0393 inches) to about 2.54 cm (1 inch) apart. FIGS. 33b-c. In another example, the liner 3203 can be connected to the tube frame 5 at three positions, namely, near the proximal end 10 and the distal end 11 of the tube frame 5 or near them, and at or near the approximate midpoint of the tube frame 5. (0.0393 inches) to about 2.54 cm (1 inch) apart. FIGS. 33b-c. In another example, the liner 3203 can be connected to the tube frame 5 at three positions, namely, near the proximal end 10 and the distal end 11 of the tube frame 5 or near them, and at or near the approximate midpoint of the tube frame 5. (0.0393 inches) to about 2.54 cm (1 inch) apart. FIGS. 33b-c. In another example, the liner 3203 can be connected to the tube frame 5 at three positions, namely, near the proximal end 10 and the distal end 11 of the tube frame 5 or near them, and at or near the approximate midpoint of the tube frame 5. (0.0393 inches) to about 2.54 cm (1 inch) apart. FIGS. 33b-c. In another example, the liner 3203 can be connected to the tube frame 5 at three positions, namely, near the proximal end 10 and the distal end 11 of the tube frame 5 or near them, and at or near the approximate midpoint of the tube frame 5.

[0109] In a preferred example, each fusion segment 3301 can have a width of from about 1 mm (0.0393 inches) to about 2 mm (0.0787 inches), and successive fusion segments can be spaced from about 12.7 mm (0.5 inches) or more apart.

[0110] In another example, continuous, substantially continuous and / or intermittent spiral patterns can be implemented for the (1 or more) fusion segments 3301. Fig. 33d. Such a fusion pattern can be achieved, for example, by rotating and pulling the tube frame 1005 beyond the heating point, thus providing a spiral pattern. The width, pitch and / or spacing of the spiral pattern can be the same as the dimensions and examples provided above. Fusion patterns such as dashed or intermittent spiral joints can be used. Alternatively, the liner 3203 can be fused to one or more segments proximal and / or distal to the ring, or otherwise "float" without being joined within the length of the lumen 1008 that passes through the ring. The outer jacket 1020 described below can similarly be fused to one or more segments proximal and / or distal to the ring, or otherwise "float" beyond the outer length of the ring.

[0111] The length of the tube frame 1005 can vary. The length of the tube frame can be in the range of about 15 cm to about 35 cm, about 10 cm to about 25 cm, about 20 cm to about 45 cm, about 30 cm to about 5 0 cm, about 5 cm to about 15 cm or about 1 to 5 cm.

[0112] Depending on the material and the structural requirements regarding flexibility, the wall thickness of the tube frame 5 at any point can vary, for example, from about 0.05 mm to 2 mm, for example, from 0.05 mm to about 1 mm, about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0 .8 mm, 0.9 mm, 1.0 mm, etc. The inner diameter of the tube can be, for example, about 0 . ​​​​​From about 0.1 mm to about 2 mm, or from about 0.25 mm to about 1 mm, for example, about 0.2 mm, about 0. 3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 2 mm, about 2.5 mm, about 3 mm, etc., can vary. The outer diameter of the tube frame 5 can also be, for example, from about 0.2 mm to about 3 mm, for example, about 0.2 m m, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0. 8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1. 4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2.0 mm, about 2.5 mm, about 3 mm, including thickness, can vary. The wall thickness, inner diameter, and outer diameter of the tube frame 5 are each constant over the length of the tube frame 5 or can vary along the length of the tube frame 5.

[0113] Furthermore, the inner wall of the tube, i.e., the lumen, can be coated by a liner 3201 that protects the tube frame 1005 and facilitates transporting additional instrument devices, such as guidewires and balloons, through the catheter tube to a distal position. The liner 3201 can extend along a portion of the tube or can extend over the entire length of the tube. The liner 3201 can form a partial or complete tube. The distal end 1013 of the tube frame 1005 can further include a catheter tip 1023 to assist in moving between the inside of the outer guide catheter and the anatomical structure accessed by the guide catheter extension. The catheter tip 1023 is rounded and can be

[0114] rounded and can be rounded and can be rounded and can be having a curved and / or tapered non-traumatic profile, and the catheter tip 1023 is substantially coaxial with the longitudinal axis LA of the tube frame 1005, and the lumen 1008 therethrough, and can be connected to the distal end of the tube frame 5. The catheter tip 1023 is fixed to the tube frame 1005 by fusing the catheter tip 1023 with an axial protrusion 1021 extending from the inner wall 1006, the outer jacket 3401, the liner 3201, and / or the distal end 1013 of the tube frame 1005. In the example shown in FIG. 34, the catheter tip 1023 is "sandwiched" between a portion of the liner 3201 and the outer jacket 3401 and is further fused to a portion of the axial protrusion 1021. FIG. 34. In the example shown in FIG. 34, the catheter tip 1023 is "sandwiched" between a portion of the liner 3201 and the outer jacket 3401 and is further fused to a portion of the axial protrusion 1021.

[0115] The catheter tip 1023 can be constructed from a relatively soft or compliant material such as PEBAX®. The tip can be radiopaque, which can be achieved by including or injecting the tip material with tungsten, bismuth, and / or barium sulfate, or as otherwise described herein. Alternatively, at least two radiopaque markers, such as bands that substantially or completely surround the tube frame 1005, can be placed along the tube frame 1005 to assist in radiographic visualization. The markers can include radiopaque materials such as

[0116] platinum metal, platinum-iridium, Ta, gold, etc. in the form of wire coils or bands, vapor deposition deposits, and radiopaque powders or fillers, such as barium sulfate, bismuth trioxide, bismuth subcarbonate, etc. embedded or encapsulated in a polymer matrix. can be included. deposits, and radiopaque powders or fillers, such as barium sulfate, bismuth trioxide, bismuth subcarbonate, etc. embedded or encapsulated in a polymer matrix. can be included. can be included. Alternatively, the marker can be made of a radiation-opaque polymer such as radiation-opaque polyurethane. It can be made from.

[0117] In another embodiment, the catheter tip has a proximal end 3501 and a distal end 3502, The distal end 3502 forms a curved inwardly curved opening having a diameter Dt that is smaller than the diameter of the lumen 1008 of the tube frame 1005. Near the distal end 3502 The catheter tip 3501 can include several incisions to make the distal tip easier to bend, i.e., a relatively small "nose cone" shaped end to minimize trauma to the blood vessel wall as the distal tip advances into the patient's vasculature. It can include.

[0118] In another type of catheter tip structure, the tapered core wire terminates in front of the tip weld. In such a structure, a very thin metal ribbon is typically attached to the core wire at one (proximal) end and to the tip weld at the other (distal) end. The ribbon functions as a safety element to maintain the connection between the core wire and the distal tip weld in case the coil breaks. The ribbon also functions to hold the formed bends in the ribbon and maintain the tip in a bent configuration as desired when manipulating and steering the guide wire. Further, by terminating the core wire in front of the tip weld, the segment of the helical coil between the distal end of the core wire and the tip weld becomes extremely flexible and flexible. The flexible tip is desirable in situations where the vasculature is highly tortuous and the guide wire must conform to and follow the tortuous anatomical structure while minimizing trauma to the blood vessel. Another type is desirable in situations where the vasculature is highly tortuous and the guide wire must conform to and follow the tortuous anatomical structure while minimizing trauma to the blood vessel. anatomical structure that it cannot follow. Another type In the tip structure, it functions as a single piece integrated with the core wire while performing the same function as the formed ribbon. So that the most distal segment of the core wire is flattened (flattened and dropped in). The tip of the flattened segment is attached to the tip weld.

[0119] The outer jacket 1020 can be constructed from nylon, polyether block amide, PTFE, FE P, PFA, PET, PEEK, etc., and / or combinations or composite materials thereof. The outer jacket 125 has a wall thickness of about 0.00508 mm (0.00020 inches) to about 0.127 mm (0.0050 inches) to minimize any increase in the outer diameter of the guide catheter 102 compared to the outer diameter of the tube frame 1005. It can have. In a preferred example, the outer jacket 1020 can have a wall thickness of about 5 microns (0.00020 inches) to about 10 microns (0.00040 inches). The outer jacket 10 20 can extend to the length 1014 of the tube frame 1005. The outer jacket 1020 provides a non-traumatic protective cover that covers the ring to eliminate or significantly reduce any trauma or pinching of the surrounding tissue when the ring bends against the contour and moves through a curved anatomical structure.

[0120] The outer jacket 1020 shown in FIGS. 30 and 34 has a substantially smooth cylindrical configuration, but the outer jacket 1020 facilitates, complements, and / or contributes to the overall flexibility of the distal assembly. It may include one or more cut patterns or other geometric features. For example, as shown in FIG. 36a, the outer jacket 1020 has a may include an intermittent helical cut pattern. Alternatively, the outer jacket 1020 may include a series of spaced-apart substantially linear cuts or holes therein, as shown in FIG. 36b. In another example, the outer jacket 1020 may have a substantially bellows-like configuration, as shown in FIG. 36c. FIG. 36d shows another example, where the outer jacket 1020 may include a wound helical configuration.

[0121] The outer jacket 1020 can be made of a polymer, for example, by surrounding the tube wall with a multi-layer single co-extruded polymer tubular structure and heat-shrinking the tubular structure or coating the tube frame 1005 through an immersion coating process. The material of the polymer jacket can be nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxy alkane), PET (polyethylene terephthalate) or PEEK (polyether ether ketone). Further, a part of the tube frame 5 (or the entire length of the guide catheter extension including the guide catheter) can be coated with a hydrophilic polymer coating to enhance lubricity and tracking. The hydrophilic polymer coating can include, but is not limited to, polyelectrolyte polymers and / or non-ionic hydrophilic polymers. The polyelectrolyte polymers can include poly(acrylamide-co-acrylic acid) salts, poly(methacrylamide-co-acrylic acid) salts, poly(acrylamide-co-methacrylic acid) salts, etc. The non-ionic hydrophilic polymers can include poly(lactam), for example, polyvinylpyrrolidone (PVP), polyurethane, homopolymers of acrylic acid and methacrylic acid ​ Polymers and copolymers, polyvinyl alcohol, polyvinyl ether, sinapic acid anhydride-free anhydride-based copolymers, polyesters, hydroxypropyl cellulose, heparin, dextran, polypeptides etc. may be used. For example, see U.S. Patent No. 6,458,867 and U.S. Patent No. 8 ,871,869. The coating can be applied by an immersion coating process or by spraying the coating on the outer and inner surfaces of the tube. ,871,869. The coating can be applied by an immersion coating process or by spraying the coating on the outer and inner surfaces of the tube. and inner surfaces. It is possible.

[0122] A lubricious coating or film may be added over the outer jacket to facilitate the movement of a catheter through a blood vessel. The lubricious coating can be composed of, for example, silicone or a hydrogel, such as a vinyl polymer, a polyalkylene glycol, an alkoxypolyethylene glycol, or an uncrosslinked hydrogel, such as a polymer network of polyethylene oxide (PEO). A lubricious coating or film may be added over the outer jacket to facilitate the movement of a catheter through a blood vessel. The lubricious coating can be composed of, for example, silicone or a hydrogel, such as a vinyl polymer, a polyalkylene glycol, an alkoxypolyethylene glycol, or an uncrosslinked hydrogel, such as a polymer network of polyethylene oxide (PEO). A lubricious coating or film may be added over the outer jacket to facilitate the movement of a catheter through a blood vessel. The lubricious coating can be composed of, for example, silicone or a hydrogel, such as a vinyl polymer, a polyalkylene glycol, an alkoxypolyethylene glycol, or an uncrosslinked hydrogel, such as a polymer network of polyethylene oxide (PEO). A lubricious coating or film may be added over the outer jacket to facilitate the movement of a catheter through a blood vessel. The lubricious coating can be composed of, for example, silicone or a hydrogel, such as a vinyl polymer, a polyalkylene glycol, an alkoxypolyethylene glycol, or an uncrosslinked hydrogel, such as a polymer network of polyethylene oxide (PEO). It can be composed of a polymer network of polyethylene oxide (PEO).

[0123] One or more surfaces of the guide catheter extension may include a lubricious coating, a hydrophilic coating, a protective coating, or other types of coatings. Hydrophobic coatings such as fluoropolymers provide a dry lubricity that improves the handling of guide wires and device exchange. The lubricious coating improves maneuverability and lesion crossing ability. One or more surfaces of the guide catheter extension may include a lubricious coating, a hydrophilic coating, a protective coating, or other types of coatings. Hydrophobic coatings such as fluoropolymers provide a dry lubricity that improves the handling of guide wires and device exchange. The lubricious coating improves maneuverability and lesion crossing ability. One or more surfaces of the guide catheter extension may include a lubricious coating, a hydrophilic coating, a protective coating, or other types of coatings. Hydrophobic coatings such as fluoropolymers provide a dry lubricity that improves the handling of guide wires and device exchange. The lubricious coating improves maneuverability and lesion crossing ability. One or more surfaces of the guide catheter extension may include a lubricious coating, a hydrophilic coating, a protective coating, or other types of coatings. Hydrophobic coatings such as fluoropolymers provide a dry lubricity that improves the handling of guide wires and device exchange. The lubricious coating improves maneuverability and lesion crossing ability. ​​, polyvinylpyrrolidone, polyvinyl alcohol, hydroxyalkyl cellulose, al gin, saccharides, caprolactone, other compounds disclosed herein, and mixtures and combinations thereof may be included. The hydrophilic polymers may be blended among themselves or blended with an amount of water-insoluble compounds (including some polymers) to produce a coating having suitable lubricity, binding and solubility.

[0124] The tube frame 1005 (or a part thereof) may have a substantially uniform diameter over its entire length. Alternatively, the tube frame 1005 can have various diameters, for example, a tapered configuration, over its entire length.

[0125] The tube frame 1005 can have variable flexibility, kinkability, torque to breakage, torquability, followability, pushability, passability, and rotational responsiveness. Various different tests are available for testing flexibility, kinkability, torque to breakage, torquability, followability, pushability, passability, and rotational responsiveness. Various standard tests for these properties known in the art are disclosed, for example, at http: / / www.pro tomedlabs.com / medical-device-testing / cat heter-testing-functional-performance (searched on October 8, 2018). Flexibility is the property of bending without breaking. The flexibility of a tube depends on the material used, the continuous helical pattern, wall thickness, inner diameter, and outer diameter, as well as other variables. Flexibility is

[0126] It can be determined by one of the following test methods: The technique uses a proximal load cell to measure the force required to move the hamstrings through a specific flexion angle without losing function. The ability of the device to advance and retract without damaging narrow or tortuous anatomy Measure the force. Alternatively, use a roller system to measure the force that the device can withstand without kinking. It is possible to determine the smallest radius of curvature that can be measured. At a 50° inclination, F = [M x (%SR)] / (S x 100), where F = flexibility , M=total bending moment, %SR=scale reading average and S=span length) By doing so, the force and bending angle can be measured. Another method for testing flexibility is The method uses one-point and four-point bending tests to detect the force F and bending displacement f using ZWIC The purpose of the study was to evaluate the flexibility under displacement control using the K005 testing machine (https: / / www.zwick.com / en / universal-testing-machi nes / zwickiline, retrieved October 29, 2018). The highest measured data is the equation E×I=(F×L 3 ) / (3×f)(Nmm 2 ) where I=moment of inertia , E=Young's modulus, L=flexural length, f=bending displacement, and F=point force and E×I=flexibility). It represents the flexibility determined by

[0127] Torque to failure or breakdown is the torque at which plastic deformation, fracture, or breakage of catheter components occurs. The amount of twisting or rotational force a tubular member can withstand before failure. One method of testing torque is to rotate the device in a relatively proximal position so that the device By fixing the distal end while being guided through the anatomical structure performed, the break is due to the use of proximal and distal torque sensors that measure the amount of torque and rotational speed up to breakage. Another test method for calculating the torque up to breakage is by testing the torque strength immediately after immersion in water set at 37 ± 2 °C for a set time. With the guide wire placed in a fixed position, the device is inserted into a conforming guiding catheter that is constrained in a two-dimensional shape such that the most distal 10 cm of the catheter is exposed beyond the guide tip and attached to a torque gauge to reproduce access to the coronary anatomy until rotation is prevented. The remaining portion of the catheter body is rotated 360° at a time until distortion, breakage, fracture, rupture, kinking or other damage occurs along the catheter or at the catheter tip, or during a set number of rotations.

[0128] Torque property is the amount of torque or rotation lost from one end of the tube to the other end of the tube when a rotational force is applied to one end. One method of testing torque property is to use proximal and distal torque sensors to rotate the device at a relatively proximal position and measure the amount of torque transmitted through the device by fixing the distal end while being guided through the anatomical structure performed by the device. Another method of testing torque property is by using an arterial simulation device for PTCA training, such as the PTCA trainer designed by Dr. Shinsuke Nanto, T / N: T001821-2, etc., which simulates a clinical tortuous path. An indicator attached to the catheter tip and inserted through the holes in the dial. The catheter body is used as a rotor, for example, T / ​ Connect to T001923 and rotate it clockwise by approximately 1080° in 90° increments. Cate - Using the angle measured by the dial attached to the indicator at the tip of the ter, calculate the ratio of the rotation angle of the body to the rotation angle of the tip. This corresponds to the amount of torque lost during rotation.

[0129] One way to test the tracking ability is to use a proximal load cell to measure the force required to advance the device through a tortuous anatomical structure, with or without being supported by a guide accessory.

[0130] One way to test the pushability is to use proximal and distal load cells to measure the amount of force the distal tip of the device experiences when a known force is applied to the proximal end.

[0131] One way to test the passageability is to use a proximal load cell to measure the ability of the catheter device to advance and retract through a specific lesion site without losing function or damaging the tortuous anatomical structure. Additionally, the roller system can determine the worst lesion the device can withstand without damage.

[0132] One way to test the rotational responsiveness is to use proximal and distal rotary encoders to rotate the device at a relatively proximal position and measure the amount of rotation transmitted through the device by keeping the distal end free while the device is guided through a tortuous anatomical structure.

[0133] The features of the guide catheter extension disclosed and described herein are of existing catheters ​​​​​​​​​​​provides significantly improved performance compared to. The distal assembly incorporating the features described herein stereolith has an average stiffness of about 0.03 N / mm to about 0.10 N / mm along its substantial length and can provide, which represents an improved ability compared to existing prior art devices . The unexpected improved ability of the entire guide catheter extension resulting from combinations of the various specifications described herein (e.g., intermittent liner coupling, cut pattern of tube frame 1005, wall thickness, and other features) is demonstrated by the ability of the elongating catheter 1000 to pass through narrow curvatures that other devices cannot pass through. Further, the cut pattern within the tube frame provides improved flexibility compared to conventional braided or coil-reinforced catheters of the prior art, while at the same time providing improved lumen integrity (e.g., the ability to maintain lumen diameter during significant bending and movement through tortuous anatomical structures).

[0134] For example, FIG. 37 is a photograph of three different prior art devices ("PA1", "PA 2", "PA3") being pushed through the same curved path with a radius decreasing from left to right via a guide wire GW. The stopping points SP where each of the prior art devices stops and does not proceed further along the path under axial negative load (i.e., due to kinking, deformation, or otherwise) are circled. In comparison, an example of a guide catheter extension is pushed through the same curved path via a guide wire and reaches the stopping point SP successfully with a much smaller radius (a small radius of about 2.54 mm) without kinking or material deformation compared to the prior art devices. This shows that the guide catheter extension has a better ability than existing devices ​​​​​​​​​​​Pass through small, highly serpentine anatomical structures and vascular systems, thereby demonstrating the ability for a wider range of treatment options and a more extensive application of location.

[0135] The variable flexibility of the tube frame section also facilitates surgical procedures that require collateral access or encounter tortuous vascular systems, such as in the central nervous system. The mechanical properties of the base tube material, tube dimensions (OD / ID), wall thickness, and the mechanical properties of the cut tube resulting from the cut pattern along the tube (material composition, UTS, elongation, modulus of elasticity), considering the wide variety of combinations from these and other combinations of material and mechanical properties (UTS, cut pitch angle, cut width, helical cut arc length, and the formula defining the non-cut helical interval between the next helical arc cut), all of which enable the designer to adjust the various mechanical properties defined over the travel length of the cut tube. Such properties resulting from the use of rigidity, flexibility, and shape memory, etc., define a predefined curved shape and are programmable and changeable.

[0136] Furthermore, such induced shape memory forms are straightened or reduced and maintained via a resistive load force along the cut and shaped portion of the distal tubular segment to orient the shape-setting portion of the tube back into a straight coaxial configuration, requiring a greater force to maintain, thereby enabling the catheter to be advanced to the vascular target.

[0137] Such variables combined together to create a wide variety of structural shapes of the tube. These structural shapes exhibit mechanical deformation characteristics that exceed the spring constant of the curved shape Wire following, for example by advancing a tube along a guide wire, can be temporarily reduced in series. This temporary deformation allows the catheter (tube) to be advanced through the anatomical structure of the blood vessel via the guide wire. Briefly stated, the spring constant of the shaped curve portion is smaller than the spring constant of the wire segment it follows. When the spring constant of the retaining guide wire segment is smaller than the spring constant of the set curve shape, the cut tube segment returns to its predetermined shape unless affected by additional external forces or vessel constriction. Such a method can be performed to access and treat innumerable various symptoms and / or diseases within anatomical regions including peripheral, cardiovascular, and nerves (e.g., the central nervous system) where access is minimal or difficult. For example, in the aortic arch, hepatic artery configuration, gastric artery, celiac artery, superior mesenteric artery, renal artery, femoral artery, and axillary artery, complex anatomical diversity of blood vessels is often seen. Kahn et al. Complex arterial patterning in an anatomical donor. Translational Research in Anatomy. 12:11 - 19(2018). The anatomical structure of a particular vascular system has direct clinical relevance, especially during invasive diagnostics and surgical procedures. Not only can the anatomical structure of the vascular site vary significantly, but the procedure may require the use of multiple devices such as wires, balloons, and guide catheters. Guide catheter extension devices such as the devices disclosed herein For example, if the spring constant of the retaining guide wire segment is smaller than the spring constant of the set curve shape, the cut tube segment returns to its predetermined shape unless affected by additional external forces or vessel constriction. Briefly stated, the spring constant of the shaped curve portion is smaller than the spring constant of the wire segment it follows. When the spring constant of the retaining guide wire segment is smaller than the spring constant of the set curve shape, the cut tube segment returns to its predetermined shape unless affected by additional external forces or vessel constriction. Unless affected by additional external forces or vessel constriction, the cut tube segment returns to its predetermined shape.

[0138] Such a method can be performed to access and treat innumerable various symptoms and / or diseases within anatomical regions including peripheral, cardiovascular, and nerves (e.g., the central nervous system) where access is minimal or difficult. For example, in the aortic arch, hepatic artery configuration, gastric artery, celiac artery, superior mesenteric artery, renal artery, femoral artery, and axillary artery, complex anatomical diversity of blood vessels is often seen. Kahn et al. Complex arterial patterning in an anatomical donor. Translational Research in Anatomy. 12:11 - 19(2018). For example, in the aortic arch, hepatic artery configuration, gastric artery, celiac artery, superior mesenteric artery, renal artery, femoral artery, and axillary artery, complex anatomical diversity of blood vessels is often seen. Kahn et al. Complex arterial patterning in an anatomical donor. Translational Research in Anatomy. 12:11 - 19(2018). For example, in the aortic arch, hepatic artery configuration, gastric artery, celiac artery, superior mesenteric artery, renal artery, femoral artery, and axillary artery, complex anatomical diversity of blood vessels is often seen. Kahn et al. Complex arterial patterning in an anatomical donor. Translational Research in Anatomy. 12:11 - 19(2018). Complex arterial patterning in an anatomical donor. Translational Research in Anatomy. 12:11 - 19(2018). Complex arterial patterning in an anatomical donor. Translational Research in Anatomy. 12:11 - 19(2018). Complex arterial patterning in an anatomical donor. Translational Research in Anatomy. 12:11 - 19(2018). The anatomical structure of a particular vascular system has direct clinical relevance, especially during invasive diagnostics and surgical procedures. Not only can the anatomical structure of the vascular site vary significantly, but the procedure may require the use of multiple devices such as wires, balloons, and guide catheters. Not only can the anatomical structure of the vascular site vary significantly, but the procedure may require the use of multiple devices such as wires, balloons, and guide catheters. Guide catheter extension devices such as the devices disclosed herein It is possible to provide improved delivery of multiple interventional devices to such anatomical structures. can

[0139] In one example of use, a guide catheter extension 1000 is used to supplement and extend the reach of a typical guide catheter to ultimately reach and / or treat an anatomical location. For example, as shown in FIGS. 38 - c, a typical guide catheter GC1 201 can be passed through the aortic arch via a guide wire GW3001 to a small opening in a coronary artery that may have a stenotic lesion for treatment. When the distal end of the guide catheter GC1201 is positioned at the small opening of the coronary artery, the guide catheter extension 1000 passes through the interior of the guide catheter GC1 201 and further extends distally the distal end of the guide catheter GC1201 deeper into the coronary artery.

[0140] The guide wire GW3001 can then be pushed through the stenotic lesion or other occlusion. In some cases, when force is applied to the guide wire GW3001, in the case of a hard stenotic or occlusive lesion, there is a possibility that the guide catheter GC1201 may fall out of the small opening of the coronary artery. However, the combination of the guide catheter GC1201 and the extended guide catheter extension 1000 inserted into the small opening improves the distal fixation of the device and also provides firmer secondary support than the external guide catheter GC1201 alone, thereby resisting dislodgment as the guide wire GW 3001 penetrates the lesion and further improves secondary support to assist in positioning a subsequent treatment catheter that may include a stent or balloon.

[0141] Pushing the guide wire GW3001 through the stenotic lesion or occlusive lesion, a stent , a therapeutic catheter (not shown in the figures) including a balloon and / or other therapeutic or diagnostic components can be passed along a guide wire to treat a lesion. Such methods can be performed to access and treat innumerable various conditions and / or diseases within anatomical regions where access is minimal or difficult. For example, in the aortic

[0142] arch, hepatic arterial configuration, gastric artery, celiac artery, superior mesenteric artery, renal artery, femoral artery, and axillary artery, there is often a complex anatomical diversity of blood vessels. Kahn et al. Comple x arterial patterning in an anatomical d onor. Translational Research in Anatomy. 1 2:11 - 19(2018). The anatomical structure of a particular vascular system has direct clinical relevance, especially during invasive diagnostics and surgical procedures. Not only can the anatomical structure of vascular sites vary significantly, but the procedure may require the use of multiple devices such as wires, balloons, and guide catheters. A guide catheter extension device such as the device disclosed herein can provide improved delivery of multiple interventional devices to such anatomical structures. The scope of the present disclosure is not limited by what has been specifically shown and described above. Those skilled in the art will recognize that there are suitable alternatives to the illustrated examples of configurations, structures, dimensions, and materials. Further, the specific embodiments or figures described herein may show features not explicitly shown in other figures or embodiments, but the examples disclosed herein

[0143] are not limited to the features shown in the specific figures or described herein. One of ordinary skill in the art will recognize that there are suitable alternatives to the illustrated examples of configurations, structures, dimensions, and materials. Furthermore, the specific embodiments or figures described herein may show features not explicitly shown in other figures or embodiments, but the examples disclosed herein ​​The features and components are not necessarily mutually exclusive and can be included in various different combinations or configurations without departing from the scope and spirit of the present disclosure. It should be understood that any reference cited and discussed in this application is provided merely to clarify the description of the present disclosure and is not an admission that any reference is prior art to the present disclosure described herein. All references cited and discussed in this specification are incorporated herein by reference in their entirety. Although specific embodiments of the present disclosure have been shown and described, it will be apparent to those skilled in the art that changes and modifications can be made without departing from the spirit and scope of the present disclosure. The foregoing description and the matters described in the accompanying drawings are provided by way of example only and not by way of limitation. The specific embodiments of the present disclosure have been shown and described, but it will be apparent to those skilled in the art that changes and modifications can be made without departing from the spirit and scope of the present disclosure. The foregoing description and the matters described in the accompanying drawings are provided by way of example only and not by way of limitation. It will be apparent to those skilled in the art that changes and modifications can be made without departing from the spirit and scope of the present disclosure. The matters described in the foregoing description and the accompanying drawings are provided as examples only and not as limitations.

Claims

1. A pusher member having a lumen, a proximal end, and a distal end, A tube frame that defines a lumen, a longitudinal axis, and a proximal segment and a distal segment therein, A tube frame having a plurality of cut patterns therein, And A tongue element extending from the proximal segment of the tube frame and connected to the pusher member. A guide catheter extension comprising:

2. The guide catheter extension according to claim 1, wherein the pusher member has a plurality of cut patterns therein.

3. The guide catheter extension according to claim 2, wherein the pusher member has a plurality of intermittent spiral cut patterns.

4. The guide catheter extension according to claim 1, wherein the cut pattern of the tube frame has a plurality of intermittent spiral cut patterns.

5. The guide catheter extension according to claim 4, wherein the plurality of intermittent spiral cut patterns extend along the length of the tube frame having an average stiffness of 0.002 to 0.004 N / mm.

6. The guide catheter extension according to claim 4, wherein the plurality of intermittent spiral cut patterns extend along the length of the tube frame having an average stiffness of 0.003 N / mm.

7. The guide catheter extension according to claim 1, wherein the cut pattern of the tube frame has a continuous spiral cut pattern.

8. The guide catheter extension according to claim 7, wherein the continuous spiral cut pattern extends along the length of the tube frame having an average stiffness of 0.001 to 0.003 N / mm.

9. The guide catheter extension according to claim 7, wherein the continuous spiral cut pattern extends along the length of the tube frame having an average stiffness of 0.002 N / mm.

10. The guide catheter extension according to claim 1, wherein the cut pattern of the tube frame comprises a plurality of rings connected together by a plurality of struts, the rings being spaced apart from each other by a cut width, each ring having a width, and each strut having a width and a length.

11. The guide catheter extension according to claim 10, wherein the plurality of rings extend along the length of the tube frame having an average stiffness of 0.005 to 0.016 N / mm. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​

12. The guide catheter extension according to claim 10, wherein the ring is oriented perpendicular to the longitudinal axis of the tube frame.

13. The guide catheter extension according to claim 10, wherein the ring is disposed in the distal segment of the tube frame.

14. The guide catheter extension according to claim 10, wherein the plurality of struts form at least one helical pattern in the distal segment of the tube frame.

15. The guide catheter extension according to claim 10, wherein the plurality of struts are aligned along at least one line running substantially parallel to the longitudinal axis of the tube frame.

16. The guide catheter extension according to claim 15, wherein the struts are arranged every other ring.

17. The guide catheter extension according to claim 10, wherein the struts in adjacent rings are angularly offset from each other at a radial angle in the range of about 5 degrees to about 180 degrees.

18. The guide catheter extension according to claim 1, wherein a virtual plane formed by bisecting the tube frame at the proximal end of the tube frame is perpendicular to the longitudinal axis of the tube frame.

19. The guide catheter extension according to claim 1, wherein the tube frame comprises a plurality of protrusions extending from the proximal end of the tube frame.

20. The guide catheter extension according to claim 19, wherein the protrusions terminate at a plurality of points on a virtual plane perpendicular to the longitudinal axis of the tube frame.

21. The guide catheter extension according to claim 20, wherein the protrusions are connected to a flare.

22. The cut pattern of the tube frame is along a portion of the length of the tube with at least one zone, where the zone comprises a plurality of units, the units of the zone being circumferentially distributed around the tube within at least one first band, each unit of the zone comprising at least one notch segment oriented around a center of symmetry, the center of symmetry of each unit within the band being equally spaced from the center of symmetry of an adjacent unit within the same band, and the center of symmetry of each unit being in a third band that is one band away from the first band. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ It is arranged at a point on the circumference of the tube that is the same as the center of symmetry of the second unit inside the tube. A shaved color transition section arranged adjacent to the tube, where the transition section has a tapered edge, a short end, and a long end. A pressing member attached to the long end of the transition section. The guide catheter extension according to claim 1, comprising:

23. The at least one zone has an average rigidity of 0.002 to 0.004 N / mm. The guide catheter extension according to claim 22, extending along the length of the tube frame. extension.

24. The at least one zone has an average rigidity of 0.003 N / mm and extends along the length of the tube frame. The guide catheter extension according to claim 22.

25. Each unit includes three notch segments extending radially from the center of symmetry of the unit. Each notch segment of the unit is arranged at an angle of 120° from the other notch segments within the unit within the band. The guide catheter extension according to claim 22. extension.

26. It further includes seven zones, namely, a first zone, a second zone, a third zone, a fourth zone , a fifth zone, a sixth zone, and a seventh zone. Each zone is formed from a plurality of units. The sequence of notch surface area and perimeter of the cut pattern is such that the units of the first zone < the units of the second zone < the units of the third zone < the units of the fourth zone < the units of the fifth zone < the units of the sixth zone < the units of the seventh zone. The guide catheter extension according to claim 22. zone < the units of the sixth zone < the units of the seventh zone. The guide catheter extension according to claim 22.

27. The zones are sequentially arranged as a first zone, a second zone, a third zone, a fourth zone, a fifth zone, a sixth zone, and a seventh zone. The guide catheter extension according to claim 22. extension. The guide catheter extension according to claim 22.

28. The cut pattern of the tube frame comprises a single cut pattern. The guide catheter extension according to claim 1. extension.

29. The cut pattern of the tube frame comprises at least two cut patterns selected from the group consisting of a continuous spiral, an intermittent spiral, interconnected rings and zones, or combinations thereof. The guide catheter according to claim 1. at least two cut patterns selected from the group consisting of a continuous spiral, an intermittent spiral, interconnected rings and zones, or combinations thereof. The guide catheter according to claim 1. at least two cut patterns selected from the group consisting of a continuous spiral, an intermittent spiral, interconnected rings and zones, or combinations thereof. The guide catheter according to claim 1.

30. At least one non-cut segment of the tube frame is disposed between two cut patterns, the guide catheter extension according to claim 29. **Claim 31** At least one non-cut segment is disposed along the tube frame, the guide catheter extension according to claim 29. **Claim 32** At least a part of the lumen of the tube frame is provided with the polymer liner bonded to the inner wall of the tube frame by at least one contact region between the polymer liner and the inner wall along the length of the tube, the guide catheter extension according to claim 1. **Claim 33** The polymer liner forms a tube, and the tube is coaxially disposed within the lumen of the tube frame, the guide catheter extension according to claim 32. **Claim 34** The polymer liner comprises at least two polymer layers, each polymer layer having a different glass transition temperature, the guide catheter extension according to claim 32. **Claim 35** The polymer layer adjacent to the inner wall of the tube frame has a lower glass transition temperature (melting temperature) than the polymer layer adjacent to the lumen of the tube frame, the guide catheter extension according to claim 34. **Claim 36** The polymer liner is bonded to the inner wall of the tube at a plurality of contact regions between the polymer liner and the inner wall along the length of the tube, the guide catheter according to claim 32. **Claim 37** The polymer liner is continuously bonded to the inner wall of the tube frame along the length of the tube, the guide catheter according to claim 32. **Claim 38** The contact regions are spaced apart from each other by a distance in the range of about 1 mm to about 2.5 cm along the longitudinal axis of the tube, the guide catheter according to claim 36. **Claim 39** The polymer liner is bonded to the inner wall of the tube frame in a continuous helical pattern running along at least a part of the length of the tube frame, the guide catheter extension according to claim 32. **Claim 40** The polymer liner is bonded to the inner wall of the tube frame by melting the polymer at selected contact regions, the guide catheter extension according to claim 32. **Claim 41** ​ ​ ​ ​ ​ ​ The polymer liner is bonded to the inner wall of the tube frame by an adhesive , the guide catheter extension according to claim 32.

42. The polymer layer adjacent to the inner wall of the tube is a polyether block amide , the guide catheter extension according to claim 34.

43. The polymer layer adjacent to the lumen of the tube frame is polytetrafluoro ethylene (PTFE), the guide catheter extension according to claim 42.

44. The polymer layer adjacent to the lumen of the tube frame is coated with a lubricious material , the guide catheter extension according to claim 34.

45. The tube frame is covered by an outer jacket, the guide catheter extension according to claim 1.

46. The proximal segment of the tube frame has a lower axial flexibility than the distal segment of the tube frame , the guide catheter according to claim 1.

47. The pushing member has a cross-sectional width in the range of about 0.25 mm to about 2.5 mm, according to claim 1 , the guide catheter extension described.

48. The pushing member has a cross-sectional width in the range of about 0.25 mm to about 0.76 mm, according to claim 4 , the guide catheter extension according to claim 45.

49. The pushing member is constructed from a hypo tube having an inner lumen, according to claim 1 , the guide catheter extension described.

50. The pushing member defines a substantially rectangular cross-section along a length, according to claim 1 , the guide catheter extension described.

51. The length of the tube frame is in the range of about 5 cm to about 150 cm, according to claim 1 , the guide catheter extension described.

52. The length of the tube frame is in the range of about 50 cm to 100 cm, according to claim 1 , the guide catheter extension described.

53. The tube frame includes a plurality of protrusions extending from the proximal end of the tube frame , the guide catheter extension according to claim 1.

54. The tube frame includes a plurality of protrusions extending from the distal end of the tube frame , the guide catheter extension according to claim 52.

55. The tube frame further includes a flare connected to the protrusion on the proximal end of the tube frame, the front The marker flare is the guide catheter extension according to claim 52, constructed from a polymer.

56. The catheter tip is connected to the protrusion on the distal end of the tube frame, and the The catheter tip is the guide catheter extension according to claim 53, constructed from a polymer. portion.

57. The guide catheter extension according to claim 56, wherein the polymer is impregnated with a radiopaque material. portion.

58. The guide catheter extension according to claim 1, wherein the tube frame is constructed from nitinol. portion.

59. On both sides of the tongue element, two cuts are arranged within the tube frame, and each cut runs substantially parallel to the longitudinal axis of the tube. The guide extension catheter according to claim 1.

60. Each of the cuts terminates within the proximal segment of the tube frame at a keyhole. The guide extension catheter according to claim 58.

61. The guide catheter extension is surrounded by an outer jacket, and the outer jacket is coated with a lubricious material. The guide catheter extension according to claim 1.

62. A guide catheter extension, A push member having a proximal end and a distal end, A tube frame connected to the distal end of the push member, through which an interventional vascular device is received. A lumen having a diameter sufficient to receive the device, and a tube frame defining an inner wall, Comprising, the tube frame includes a distal segment having a plurality of rings, and each of the rings is interconnected by a plurality of connecting portions and a tongue extending from the proximal segment of the tube. The tongue is connected to the push member. The guide catheter extension. portion.

63. The guide catheter extension according to claim 62, wherein the connections between adjacent rings of the plurality of connecting portions are axially aligned. portion.

64. The guide catheter extension according to claim 62, wherein the connections between adjacent rings of the plurality of connecting portions are angularly offset from each other at an angle in the range of about 5 degrees to about 180 degrees. portion.

65. The guide catheter extension according to claim 63, wherein the plurality of connecting portions form a helical pattern along the distal segment of the tube frame. tern.

66. A polymer disposed within the lumen and extending through the plurality of interconnected rings. The guide catheter extension according to claim 62, further comprising a polymer liner. **Claim 67** The polymer liner comprises at least two polymer layers, each polymer layer having a different glass transition temperature, and the polymer layer adjacent to the inner wall of the tube frame has a glass transition temperature (melting temperature) lower than that of the polymer layer adjacent to the lumen, The guide catheter extension according to claim 66. **Claim 68** Further comprising an outer polymer jacket covering at least a portion of the plurality of rings, the outer polymer jacket not being fused to any portion of the plurality of rings, The guide catheter extension according to claim 67. **Claim 69** A guide catheter extension, comprising: A pushing member having a proximal region and a distal region; A tube frame connected to the distal end of the pushing member; The tube frame defines a lumen therethrough having a diameter sufficient to receive an intervening heart device therethrough, the tube frame having an average stiffness of about 0.03 N / mm to about 0.10 N / mm along its substantial length. The guide catheter extension according to claim 69. **Claim 70** The guide catheter extension according to claim 69, wherein the tube frame can be pushed through a curve having a radius of about 2.5 mm without kinking. **Claim 71** The guide catheter extension according to claim 70, wherein the tube frame has a wall thickness of about 0.0254 mm to about 0.254 mm. **Claim 72** The guide catheter extension according to claim 71, wherein the tube frame has a wall thickness of about 0.0635 mm to about 0.1143 mm. **Claim 73** Further comprising a polymer liner at least partially disposed within the lumen of the tube frame, the polymer liner being partially bonded to the tube frame. The guide catheter extension according to claim 72. **Claim 74** The guide catheter extension according to claim 73, wherein the polymer liner has a wall thickness of about 0.00635 mm to about 0.127 mm. **Claim 75** The guide catheter extension according to claim 73, wherein the polymer liner is bonded to the tube frame at a plurality of discrete positions along the length of the tube, and the width of each bond at each discrete position is about 1 mm to about 2 mm. **Claim 76** ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Further comprising a plurality of rings disposed in the distal region of the tube frame, and the width of each ring is from about 50 microns to about 200 microns, the guide catheter extension according to claim 69. **Claim 77** The guide catheter extension according to claim 76, wherein each ring is spaced from an adjacent ring by from about 10 microns to about 300 microns. **Claim 78** Further comprising an outer polymer jacket covering at least a portion of the plurality of interconnected rings, the outer polymer jacket not being fused to any portion of the plurality of interconnected rings, and the outer polymer jacket having a wall thickness of from about 5 microns to about 10 microns. rons, the guide catheter extension according to claim 76. **Claim 79** Further comprising a tongue element extending from the proximal segment of the tube frame, the tongue being connected to the pushing member, the guide catheter extension according to claim 69. ​ ​

Images