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  • 专利说明
  • 权利要求
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    • 专利摘要:
    NON-CIRCULAR INTERNAL LUMEN GUIDE CATHETER WITH VARIABLE ASSISTED SUPPORT. The present invention relates to a non-circular internal lumen guiding catheter with variable assisted support that has an internal wall that defines a non-circular cross-shaped lumen for use in the application of multiple mircocatheters or other devices for the treatment of neurovascular defects , as for the treatment of aneurysm. The non-circular internal lumen guide catheter with variable assisted support includes torque transmission guide walls that are linearly flexible but not circumferentially, and are neither retractable nor foldable. The non-circular cross-section of the internal lumen may extend along the entire length of the catheter or a portion thereof, which includes a distal or proximal portion.
    公开号:BR102012008908B1
    申请号:R102012008908-4
    申请日:2012-04-16
    公开日:2021-01-26
    发明作者:Roberto Echarri；Clifford D. Taylor；Eric Williams
    申请人:DePuy Synthes Products, LLC；
    IPC主号:
    专利说明:

    BACKGROUND OF THE INVENTION
    [0001] The present invention relates in general to guide catheters for the placement of devices for interventional therapeutic treatment of defects in the vasculature and, more particularly, it refers to guide catheters that have supplementary torque transmission and guide walls that can be designed to have variable linear flexibility compared to rotational flexibility and torque capacity and that are not readily retractable or foldable when in use, to release intravascular interventional devices for the treatment of defects in the neurovasculature, such as for the treatment of aneurysms.
    [0002] Vascular interventional devices such as vaso-occlusive coils and the like can typically be placed inside the vasculature through the use of a catheter. Vaso-occlusive devices can be placed inside a blood vessel to modify the flow of blood through the vessel by deflecting or mitigating the blood flow in a damaged or leaking part of the vessel, or are placed inside an aneurysm or other obstructed malformation of the vessel to form an embolus within the aneurysm or some combination of techniques to repair a neurovascular defect. The vaso-occlusive devices used for these procedures can also have a wide variety of configurations and the aneurysms were treated with clips placed surgically on the outside, separable vaso-occlusive balloons and plunger generating vaso-occlusive devices such as one or more vaso-occlusive coils . The application of such vascular devices has usually been carried out through a variety of means, including by means of a catheter in which the device is pushed through an opening at the distal end of the catheter by means of a propellant to implant the device. Vascular devices can be produced in such a way that they will pass through the lumen of a catheter in a linear shape and will assume a complex shape as originally formed after being implanted in the area to be treated.
    [0003] The insertion of a guide catheter or delivery catheter system in a desired arterial point is the first step for modern forms of endovascular treatment and one of the most important steps for the treatment of defects in the neurovasculature. The size of the perforation site in an artery is of critical importance, as is the ability to guide and torque the repair and treatment device to the desired location in the neurovasculature. Usually, prior art guide catheters had a circular cross-sectional shape. It would be desirable to provide a guide catheter or delivery catheter having a cross-sectional shape that would reduce the equivalent French-sized cross-section to reduce the size of the perforation site, while maintaining the advantages of a larger-sized catheter for the application from a plurality of microcatheters to a treatment site. It would also be desirable to provide a guide catheter or delivery catheter having a cross-sectional shape that can flex more easily and that can be constructed to have variable torque and longitudinal flexion profiles. The present invention satisfies these and other needs. SUMMARY OF THE INVENTION
    [0004] Briefly, and in general terms, the present invention features a guide catheter with at least one non-circular internal lumen with variable assisted support between the internal lumens and the external surface of the catheter for use in the application of multiple microcatheters to treat defects neurovascular. A non-circular internal lumen guide catheter with variable assisted support of the present invention includes torque transmitting guidance structures in the area between the internal lumen which is designated as being relatively flexible along the longitudinal axis of the catheter, but is designated as being relatively resistant to torque and flexion around the lateral axis of the catheter, thus enhancing the ability of the catheter resulting in resisting the retraction or flexion of the site in use.
    [0005] When changing the cross-sectional shape of a guide catheter or delivery catheter that has a lumen accommodating multiple microcatheters, the guide catheter or delivery catheter may have a smaller cross-sectional area and therefore a smaller perforation size. By changing the shape in cross section of the catheter lumen from a circle to a non-circular shape, two 0.0432 cm (0.017 ”devices can be accommodated in an equivalent 5Fr guide catheter that adapts to the 6Fr delivery system, but it has a smaller profile, thus limiting the trauma to the vessel. The catheter rod can be composed of a braid / coil construction that can also include a polymeric material, with a slippery internal lumen of ethylene polytetrafluoro (PTFE) available under the Teflon® trade name of EI Du Pont de Nemours and Company Corporation (Wilmington, DE, USA) to optimize the process of changing the wire in the most distal sections of the arteries.The proximal area of the guide catheter will have an ergonomically designed central part to allow a doctor to easily manipulate the catheter, and to insert other medical devices. The guide catheter includes a progressively malleable, segmented tip design configured to produce a linear change ear in stiffness over a longitudinal portion of the device and incorporates a malleable polymeric material to minimize trauma to the vessel. The outside of the catheter is covered with a polymeric material to encapsulate a stainless steel and / or platinum braid / coil construction thus protecting the walls of the arteries and other tissue. In a currently preferred embodiment, the polymeric material may include a slippery hydrophilic outer coating. In a currently preferred aspect, the guide catheter has an internal lumen that has a cross-section with a shape that consists of two parallel straight segments connected at its ends to two curved line segments. In another currently preferred aspect, the guide catheter has an internal lumen that has a cross section with a flattened oval shape. In another currently preferred aspect, the guide catheter has an internal lumen that has a cross section with a flattened circle shape. In another currently preferred aspect, the guide catheter has an internal lumen with an oval cross-sectional shape throughout the device. In another currently preferred aspect, the guide catheter may have a round external cross-sectional shape along the length of the device, with a proximal portion that has an internal lumen with a non-circular cross-sectional shape, and a distal portion that has an internal lumen with a circular shape in cross section.
    [0006] In one of several aspects, the invention includes a guide catheter, which has an elongated wall structure that extends along the length of the catheter defining an inner lumen and an outer lumen, the inner lumen that has a cross-sectional shape non-circular and the outer lumen that is substantially shaped in cross section of at least a portion of a curved geometric figure.
    [0007] In various embodiments, the outer wall of the outer lumen may vary in stiffness along its length. The guide catheter may also have an elongated spring member disposed on an outer wall of the wall structure. The wall structure between the inner lumen and the outer lumen may include a torque orienting portion that is substantially flexible linearly and not circumferentially. The inner lumen may have a non-circular cross-sectional shape. The inner lumen may have a cross-sectional shape consisting of two straight parallel line segments connected to each other at one end by two curved line segments. The two curved line segments can be mirrored symmetrical images of each other. The inner lumen may have a cross-sectional shape of a flattened oval. The inner lumen may have a cross-sectional shape of a flattened circle. The internal lumen can substantially have the shape of a complete oval in cross section. The outer lumen can substantially have the shape in cross section of at least a portion of a curved geometrical figure and can be arranged on one side of the inner lumen. The outer lumen can substantially be shaped in cross-section of at least a portion of a circle and can be arranged on one side of the inner lumen. The wall structure can also define a second external lumen that has the shape in cross section of a portion of a circle disposed on the opposite side of the internal lumen. The wall structure defining the inner lumen and the inner lumen can extend distally beyond the outer lumens. The wall structure of the catheter defining the lumens may include an external catheter surface that has a substantially circular cross-section that tapers inwardly and in a distal position to an external catheter surface that continues in a distal position having a cross-section in non-circular shape. For example, the non-circular cross-section can consist of two straight parallel line segments connected to each other at each end by two curved line segments. The non-circular cross-section can also be a flattened oval, a flattened circle, a figure of revolution substantially representing an oval, an oval, and the like. The wall structure defining the outer lumens can extend distally beyond the inner lumen. A distal portion of the wall structure can be segmented and progressively malleable. The guide catheter may also have a floating coil or spring constricted on an external wall of the wall structure. The guide catheter may also have an elongated stiffener in the outer lumen. The stiffener can vary in hardness along its length. The elongated stiffener may taper over at least a portion of the length of the stiffener. The length portion of the elongated stiffener may have a changing taper angle. The length portion of the elongated stiffener may have contiguous tapered segments with different tapering angles.
    [0008] In various embodiments of the present invention, one or more of the external lumens can be expandable and / or retractable. The guide catheter may include a balloon that can be inflated to expand and / or deflated to flatten through the outer lumen (s) serving as lumens of inflation / deflation to supply fluid to the balloon or suction the fluid out of the balloon. The balloon can be disposed on the outside of the catheter body or the wall structure. The guide catheter may include control wires within one or more of the external lumens that can activate a metal cage arranged on the outside of the catheter body or wall structure. A segment or layer of the guide catheter can be composed of a material that can be activated, so that its state, shape or one or more properties or characteristics change. For example, the segment or layer can be activated by heat. A liquid injected into one or more of the external lumens in the catheter body can activate this segment or layer of the guide catheter. Or an electric heating element inserted in one or more of the external lumens can activate this segment or layer of the guide catheter.
    [0009] In another aspect, the invention includes a guide catheter, which has an elongated wall structure that extends along a length of the catheter, defining an inner lumen and an outer lumen, the inner lumen having a non-cross-sectional shape circular and an elongated stiffener in the outer lumen. The shape in non-circular cross section can consist of two straight parallel line segments connected to each other at each end by two curved line segments. The two curved line segments can be mirrored symmetrical images of each other. Or the shape in non-circular cross section can also be described as: substantially at least a portion of an oval, substantially at least a portion of a curved geometric figure, a flattened oval, a flattened circle, an oval and the like.
    [00010] In several modalities, the stiffener can vary in hardness along its length.
    [00011] In yet another aspect, the invention includes a guide catheter, which has an elongated wall structure that extends along a length of the catheter defining an inner lumen and an outer lumen, the inner lumen that has a shape in shape. non-circular cross section and different wall structure in hardness along the length. The shape in non-circular cross section can consist of two straight parallel line segments connected to each other at each end by two curved line segments. Or the shape in non-circular cross section can also be described as: substantially at least a portion of an oval, substantially at least a portion of a curved geometric figure, a flattened oval, a flattened circle, an oval and the like.
    [00012] In various modalities, the wall structure has segments of different materials. The guide catheter may also have an elongated spring member disposed on an outer wall of the wall structure.
    [00013] In another aspect, the invention includes a guide catheter, which has an elongated wall structure that extends along a length of the catheter defining an inner lumen and an outer lumen, the inner lumen having a cross-sectional shape non-circular and the elongated wall structure including an external wall that has a surface with a shape that changes along the length between a shape in non-circular and circular cross section. The non-circular cross-sectional shape of the inner lumen and the non-circular cross-sectional shape of a portion of the outer wall surface of the elongated wall structure can consist of two straight parallel line segments connected to each other at each end or two segments curved line. The two curved line segments can be mirrored symmetrical images of each other. Or the shape in non-circular cross section can also be described as: substantially at least a portion of an oval, substantially at least a portion of a curved geometric figure, a flattened oval, a flattened circle, an oval and the like.
    [00014] In several embodiments, the guide catheter may also have an elongated spring element disposed on an external wall of the wall structure.
    [00015] These and other aspects and advantages of the invention will be apparent from the following detailed description and the accompanying drawings, which illustrate, by way of example, the characteristics of the invention. BRIEF DESCRIPTION OF THE DRAWINGS
    [00016] Figure 1 is a frontal view of a schematic cross-section diagram of a first modality, which illustrates a guide catheter that has a non-circular internal lumen and a round external surface, showing the external gaps or lumens between the internal walls. non-circular and round outer walls of the guide catheter.
    [00017] Figure 2 is a front view of a schematic cross-section diagram of the guide catheter in figure 1, with two microcapsules inside the non-circular internal lumen.
    [00018] Figure 3 is a front view of a diagram in schematic cross section that illustrates elements and exemplary dimensions of the guide catheter (with two microcatheters) in figure 2.
    [00019] Figure 4 is a top view of a schematic diagram of the guide catheter of figure 1 illustrating the insertion of the stiffening devices in the openings or external lumens between the non-circular inner walls and the round outer walls of the guide catheter.
    [00020] Figure 5 is a side view of a schematic diagram of the guide catheter in figure 4.
    [00021] Figure 6 is a schematic cross-sectional diagram of the guide catheter seen along line 6-6 of figure 5.
    [00022] Figure 7 is an additional detailed schematic cross-section diagram that illustrates the elements of the guide catheter (with two microcatheters) of figure 2.
    [00023] Figure 8 is an enlarged sectional view similar to figure 7 that illustrates additional elements of the guide catheter in figure 1.
    [00024] Figure 9 is an isometric perspective view of the guide catheter in figure 1.
    [00025] Figure 10 is a top view of a schematic diagram of a second embodiment of a guide catheter with a non-circular internal lumen and a round external surface that does not extend the entire length of the device.
    [00026] Figure 11 is a side view of a schematic diagram of the guide catheter according to the second embodiment.
    [00027] Figure 12 is a schematic cross-sectional diagram of the guide catheter seen along line 12 to 12 of figure 11.
    [00028] Figure 13 is an isometric perspective view of the guide catheter according to the second modality.
    [00029] Figure 14 is an isometric perspective view of a schematic diagram of the guide catheter according to the second modality.
    [00030] Figure 15 is a schematic cross-sectional view of the guide catheter of figure 10 similar to figure 12 including stiffening devices filling the gaps or external lumens between the non-circular inner walls and the round outer walls of the guide catheter.
    [00031] Figure 16 is an isometric perspective view of the guide catheter in figure 15.
    [00032] Figure 17 is a schematic cross-sectional view of the guide catheter of figure 10 similar to figure 12 including a stiffening device filling one of the gaps or external lumens between the non-circular inner walls and the round outer walls of the guide catheter.
    [00033] Figure 18 is a top view of a schematic diagram similar to figure 10 that illustrates the insertion of stiffening devices in the openings or external lumens between the internal non-circular walls and the round external walls of the guide catheter.
    [00034] Figure 19 is a side view of a schematic diagram of the guide catheter in figure 18.
    [00035] Figure 20 is a schematic cross-sectional view of the guide catheter seen on line 20 to 20 of figure 19.
    [00036] Figure 21 is a schematic cross-sectional view of the guide catheter of figure 10 similar to figure 12 including a stiffening device of the hypotube filling one of the gaps or external lumens between the non-circular inner walls and the round outer walls of the catheter guide.
    [00037] Figure 22 is an isometric perspective view of a schematic diagram of a third embodiment of a guide catheter that has a round external shape along the length of the device, with a proximal portion that has an internal lumen with a non-shape. circular and a distal portion that has an internal lumen with a round shape.
    [00038] Figure 23 is an isometric perspective view of the guide catheter in figure 22.
    [00039] Figure 24 is an isometric broken view of a schematic diagram of a guide catheter according to the present invention in which the guide catheter has a progressively malleable segmented tip design.
    [00040] Figure 25 is a side view of a stiffening device that tapers along its length according to the present invention.
    [00041] Figure 26 is a side view of a stiffening device that comprises different materials along its length according to the present invention.
    [00042] Figure 27 is a side view of a stiffening device with a continuously changing taper angle according to the present invention.
    [00043] Figure 28 is a side view of a stiffening device that has contiguous tapered segments with different tapering angles.
    [00044] Figure 29 is a schematic cross-sectional diagram of the guide catheter in which the outer wall has a coil or spring, according to an embodiment of the present invention.
    [00045] Figures 30A to B are schematic diagrams of the catheter in a blood vessel showing the external lumen as an inflation / deflation lumen for a balloon disposed over an external part of the catheter body in flattened and expanded configurations.
    [00046] Figures 31A to D are schematic diagrams of the catheter in a blood vessel showing the expandable / retractable metal cage arranged on an external part of the catheter body and activated through control wires in the external lumens in flattened and expanded configurations with and without a distal membrane.
    [00047] Figure 32 is a schematic diagram of a liquid injected into the external lumen to activate a layer or segment of the wall structure of the body of the guide catheter.
    [00048] Figure 33 is a schematic diagram of an electric heating element inserted in the external lumen to activate a layer or segment of the wall structure of the body of the guide catheter. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
    [00049] With reference to the drawings, which are provided by way of example, but without limitation, the present invention in general provides a non-circular internal lumen guide catheter.
    [00050] With reference to figures 1 to 9, in a first currently preferred embodiment, the present invention features a non-circular internal lumen guide catheter with variable assisted support 50 that has a non-circular internal lumen wall 52 defining an internal lumen 54 which has a non-circular cross-sectional format for use in the application of multiple microcatheters 56a, 56b for the treatment of neurovascular defects, such as for the treatment of aneurysms. The non-circular internal lumen guide catheter with variable assisted support of the present invention includes torque transmission guide walls 58a, 58b which are linearly flexible, but not circumferentially and which are neither retractable nor collapsible. For example, this can be done, in whole or in part, by the torque transmission guide walls that are produced from a different material than the rest of the guide catheter wall structure as shown in figure 3. More specifically, according to with one embodiment, the torque transmission guide walls can flex in a dimension perpendicular to a surface in flat cross-section of the walls, but cannot flex in a dimension parallel to a surface in flat cross-section of the walls. The outer surface may have a round outer wall 60 with a circular shape in cross section, which typically extends from the proximal end or central part of the device to the distal end or tip, while the inner lumen remains non-circular. As shown in figures 7 and 8, the inner lumen can be reinforced by a coil or braid 61, and the braid can have a variable braid angle. The non-circular internal lumen guide catheter preferably also includes first and second external spaces or lumens 62a, 62b, defined between the non-circular internal wall and the round outer wall of the guide catheter (see figures 3 to 5, 7 and 9 ). The round outer surface of the device may be composed of segments of progressively malleable polymeric material which are configured to produce a linear change in hardness over a desired longitudinal portion of the device. The outer layer can also be constructed in such a way that it has a freely floating coil or spring 160 (figure 29) built into it. One end of this coil or spring can be affixed to the inner non-circular surface, while the other end is attached to a push / pull mechanism that passes along the outer spans or lumens between the inner non-circular surface and the outer surface 60. A The actuation of the mechanism will compress or extend the coil or spring. This action will stiffen or loosen / soften the catheter shaft.
    [00051] As shown in Figures 4 to 6 and 8, the spans or outer lumens between the non-circular inner wall and the round outer wall of the guide catheter can be used as separate lumens for the insertion or manipulation of one or more devices stiffening devices 64 that can help prevent the catheter from leaving certain positions once inside the circulatory system. Such stiffening devices may be composed of a round metallic wire, a flat wire, a non-shaped hypotube shaped like a span, a wire shaped like a span, or a hypotube shaped like a span. The stiffening devices can be made from different materials (not limited to metals) and can change the material along its length. For example, as shown in figure 26, according to an embodiment of the invention, a stiffening device 150 can have several sections 151, 152, 153, 154, 155 formed from different materials. According to an embodiment shown in figure 25, the stiffening device can be a tapered stiffening device 140 that changes the thickness or tapers along the length. As shown in figure 27, according to one embodiment, the stiffening devices may have a section 142 with a tapering angle continuously changing to produce a curvilinear profile that is configured to produce a linear change in the catheter hardness. As shown in figure 28, according to one embodiment, the stiffening devices may have a section 144 of contiguous tapered segments 145, 146, 147 that have tapering angles that are configured to produce a linear change in hardness over a longitudinal portion of the device. The stiffening devices may have a slippery coating. As shown in Figure 8, a form of a stiffening device can be formed of a polymeric material shaped like a gap, including a central wire 65, which can include an external reinforcement 66 formed of a coil or braid, and it may include a coating of PTFE 67. The stiffening devices are preferably attached to the outside of the non-circular inner surface of the gap, but are free to move the entire length of the device. A simple action by the user on the proximal end will activate them so that one of them will be pushed while the other will be pulled simultaneously causing an increase in the hardness as a whole of the proximal end of the catheter. External gaps or lumens can also be used as separate lumens for insertion of the elements of the push / pull mechanism to make the tip of the catheter deflectable.
    [00052] The catheter rod is preferably composed of a braid / coil construction of stainless steel and / or platinum, with a slippery inner lumen coating 68 of PTFE to optimize the wire exchange process in the most distal sections of the arteries . The proximal area (not shown) will have an ergonomically designed central part to allow the physician to easily manipulate the catheter as well as the insertion of other medical devices.
    [00053] With reference to figures 10 to 21, in a second currently preferred embodiment, the present invention features a non-circular internal lumen guide catheter with variable assisted support 70 that has a non-circular internal lumen wall 72 defining an internal lumen 74 which has a non-circular cross-sectional format for use in the application of multiple microcatheters for the treatment of neurovascular defects, such as for the treatment of aneurysms. The non-circular internal lumen guide catheter with variable assisted support of the present invention includes guide walls for torque transmission 78a, 78b which are linearly flexible, but not circumferentially, and which are neither retractable nor collapsible.
    [00054] With reference to figures 10 to 14, the non-circular internal lumen guide catheter includes a distal portion 80 and a proximal portion 82 also including a round outer wall 84 that extends only a portion of the length of the guide catheter, and an outer tapered transition wall 86 transitioning from the non-circular external shape of the distal portion and the round external shape of the proximal portion. The round outer surface typically stops at some point along the length of the catheter, making a transition from a round proximal section to a non-circular distal section, with a non-circular lumen extending throughout the catheter. Thus, the non-circular lumen / wall may constitute the only lumen / wall in the distal portion and the internal lumen / wall in the proximal portion. This feature helps the stability of the proximal end of the device and still has a distal section with a smaller profile than conventional guide catheters resulting in less trauma. The first and second outer spans or lumens 88a, 88b are defined between the non-circular inner wall and the proximal round outer wall of the guide catheter as shown in figures 12 to 15, 17 and 21.
    [00055] As shown in figures 15 to 21, the spans or outer lumens 88a, 88b between the non-circular inner wall and the round outer wall of the guide catheter can be used as separate lumens for the insertion or manipulation of one or more stiffening devices 90 that can help prevent the catheter from returning from certain positions once within the circulatory system. Such stiffening devices may be composed of a round metallic wire, a flat wire, a non-shaped hypotube in the span, a solid wire 92 in the span shape or a hypotube 94 in the span shape. The stiffening devices can be made of different materials (not limited to metals). The stiffening devices may have a section with a continuously changing taper angle to produce a curvilinear profile that is configured to produce a linear change in catheter hardness. The stiffening devices may have a section of contiguous tapered segments that have tapering angles that are configured to produce a linear change in hardness over a longitudinal portion of the device. The stiffening devices may have a slippery coating. The stiffening devices are preferably attached to the outside of the non-circular inner surface of the span, but are free to move the entire length of the device. A simple action by the user on the proximal end can activate them so that one of them will be pushed while the other will be pulled simultaneously causing an increase in the hardness as a whole of the proximal end of the catheter. External gaps or lumens can also be used as separate lumen (s) for inserting the elements of the push / pull mechanism to make the tip of the catheter deflectable.
    [00056] The catheter rod is preferably composed of a braid / coil construction of stainless steel and / or platinum, with a slippery coating of the inner lumen 96 of PTFE to optimize the wire exchange process in the most distal sections of the arteries . The proximal area (not shown) will have an ergonomically designed central part to allow the doctor to easily manipulate the catheter as well as to insert other medical devices. The outside of the catheter is preferably covered with a polymeric material 98 to encapsulate the stainless steel and / or platinum braid / coil construction. The polymeric material preferably has a slippery hydrophilic outer coating.
    [00057] With reference to figures 22 to 23, in a third currently preferred embodiment, the present invention features a non-circular internal lumen guide catheter with variable assisted support 100 that has a non-circular internal lumen wall 102 defining an internal lumen 104 which has a non-circular cross-sectional format for use in the application of multiple microcatheters (not shown) for the treatment of neurovascular defects, such as for the treatment of aneurysms. The non-circular internal lumen guide catheter with variable assisted support of the present invention includes torque transmission guide walls 108a, 108b which are linearly flexible, but not circumferentially and which are neither retractable nor collapsible. The entire external surface of the catheter is round and the lumen changes from non-circular at the proximal end to a very flexible round at the distal end. With reference to the figure. 23, the non-circular inner lumen guide catheter includes a distal portion 110 with a round outer wall 112 defining a round inner lumen 114 and a proximal portion 116 also including a round outer wall 118 contiguous with the distal round outer wall. The first and second spans or outer lumens 120a, 120b are defined between the non-circular inner wall and the proximal round outer wall of the guide catheter as shown in figures 22 to 23. The device is reinforced with braid / coil and different polymeric segments.
    [00058] The gaps or external lumens between the non-circular inner wall and the round outer wall of the guide catheter can be used as separate lumens for the insertion or manipulation of one or more stiffening devices (see stiffening device 64 in figures 4 a 6, central wire 65 in figure 8, stiffening device 90 in figures 10, 15 to 20, hypotube 94 in figure 21, tapered stiffening device 140 in figure 25, stiffening device 150 in figure 26, tapered stiffening device 142 in figure 27, and section of tapered segments 144 in figure 28) that can help prevent the catheter from returning from certain positions once inside the circulatory system. Such stiffening devices may be composed of a round metallic wire, a flat wire, a non-shaped hypotube in the span, a wire in the span shape or a hypotube in the span shape. The stiffening devices can be made of different materials (not limited to metals). The stiffening devices may have a section with a tapering angle continuously changing to produce a curvilinear profile that is configured to produce a linear change in the catheter hardness. The stiffening devices may have a section of contiguous tapered segments that have tapering angles that are configured to produce a linear change in hardness over a longitudinal portion of the device. The stiffening devices may have a slippery coating. The stiffening devices are preferably attached to the outer side of the internal non-circular surface of the span, but are free to move the entire length of the device. A simple action by the user on the proximal end will activate them so that one of them will be pushed while the other will be pulled simultaneously causing an increase in the hardness as a whole of the proximal end of the catheter. External gaps or lumens can also be used as separate lumen (s) for insertion of the push / pull mechanism to make the catheter tip deflectable.
    [00059] The catheter rod is preferably composed of a braided / coil construction of stainless steel and / or platinum, with a slippery lumen coating of PTFE 122 to optimize the wire exchange process in the most distal sections of the arteries. The proximal area will have a central part ergonomically designed to allow the doctor to easily manipulate the catheter as well as for the insertion of other medical devices.
    [00060] Referring to Figure 30, the outer lumens formed between the non-circular inner lumen and the round outer surface of the catheter can serve as inflation / deflation lumens for a 165 polymeric balloon. The polymeric balloon can provide proximal support for the catheter or interruption of flow during an interventional therapeutic procedure. The balloon can be restricted to a proximal portion of the nail to provide proximal support to the catheter or it can extend over a length or the entire length of the nail. By supplying the fluid to or suctioning the fluid out of the external inflation / deflation lumens, the balloon can be reversibly flattened and expanded repeatedly as needed. The balloon can be anchored in place to provide and maintain interrupted flow. The balloon can be arranged over the outside of the catheter body or wall structure and communicates with the external inflation / deflation lumens that supply / suck the balloon fluid through an opening system in the external catheter body or wall structure.
    [00061] Referring to Figure 31, the outer lumens between the non-circular inner lumen and the round outer surface of the catheter positioned along the substantially flat torque transmission guide walls can be used for the passage of control wires to activate a metal cage 170. A version or portion of the metal cage can be used to support the device in various desired positions along the length of the guide catheter. For example, a metal cage expanded by activating the control wires inside external lumens at a proximal end of the catheter can provide proximal support for the catheter. In another version of the metal cage or in a restricted portion of the metal cage a polymeric membrane 173 can be provided. The polymeric membrane can take the form of a silicone coating, for example. A polymeric membrane at the distal end of the metal cage can be used to stop the flow. The metal cage can be reversibly flattened and expanded repeatedly as needed, by activating control wires arranged in the outer lumens. The metal cage can be activated by control wires contained in two small external lumens in a round coating.
    [00062] With reference to figure 32, in another application for the external lumens or gaps along the torque transmission guide walls between the non-circular internal lumen and the round external surface, the external lumens can be used for injection of a 175 liquid in them. The injection of a liquid at a certain temperature in the external lumens can serve to activate a desired polymeric segment or polymer layer 177 in the catheter body.
    [00063] Referring to figure 33, in yet another application for external lumens, they can be used to insert an electric heating element 180. The insertion of an electric heating element at a certain temperature in the external lumens can serve to activate a desired polymeric segment or polymer layer 177 in the catheter body.
    [00064] Additionally, any of the modalities can include a progressively malleable segmented tip design 130 (figure 24) that incorporates a malleable polymeric material to minimize vessel trauma. For example, according to one embodiment, the progressively malleable segmented tip design 130 may comprise several segments 131, 132, 133, 134, 135 of different materials and / or the segments can be divided into steps so that the hardness of the tip progressively malleable segmented distal 130 varies from one segment to the next. The outside of the catheter is preferably covered with a polymeric material 44 to encapsulate the stainless steel and / or platinum braid / coil construction. The polymeric material preferably has a slippery hydrophilic outer coating.
    [00065] It will be evident from the foregoing that although particular forms of the invention have been described and illustrated, various modifications can be made without departing from the spirit and scope of the invention.
    权利要求:
    Claims (21)
    [0001]
    1. Guide catheter, comprising: an elongated wall structure that extends along a length of the catheter, defining an internal lumen and an external lumen, the internal lumen having a shape in non-circular cross section (54), characterized due to the fact that the wall structure between the inner lumen and the outer lumen still comprises a torque guide portion (58a, 58b) that is made of a different material than the rest of the wall structure and that is flexible along the axis longitudinal aspect of the catheter compared to the circumferential axis of the catheter and the external lumen having the shape of the cross section of at least a part of a curved geometric figure (60).
    [0002]
    2. Guide catheter, according to claim 1, characterized by the fact that the shape in non-circular cross section of the internal lumen is defined by two parallel line segments connected at each end by two curved line segments.
    [0003]
    3. Guide catheter, according to claim 2, characterized by the fact that the two curved line segments are mirrored symmetrical images of each other.
    [0004]
    4. Guide catheter, according to claim 1, characterized by the fact that the shape in non-circular cross section is at least a portion of an oval.
    [0005]
    5. Guide catheter, according to claim 1, characterized by the fact that an external wall of the external lumen varies in stiffness along its length.
    [0006]
    6. Guide catheter according to claim 1, characterized by the fact that it still comprises: an elongated longitudinal spring element disposed on an external wall of the wall structure.
    [0007]
    7. Guide catheter, according to claim 1, characterized by the fact that the cross-sectional shape of the internal lumen is a complete oval.
    [0008]
    8. Guide catheter, according to claim 7, characterized by the fact that the external lumen has the shape in cross section of a portion of a circle and is disposed on one side of said internal lumen.
    [0009]
    9. Guide catheter, according to claim 8, characterized by the fact that the wall structure still defines a second external lumen that has the shape in cross section of a portion of a circle disposed on the opposite side of the internal lumen.
    [0010]
    10. Guide catheter, according to claim 9, characterized by the fact that the wall structure that defines the internal lumen and the internal lumen extends distally beyond the external lumens.
    [0011]
    11. Guide catheter, according to claim 10, characterized by the fact that the catheter wall structure that defines the lumens includes an external catheter surface having a circular cross-section that tapers inwardly and distally to an external catheter surface that continues distally with a non-circular cross-section.
    [0012]
    12. Guide catheter according to claim 9, characterized by the fact that the wall structure that defines the external lumens extends distally beyond the internal lumen.
    [0013]
    13. Guide catheter, according to claim 1, characterized by the fact that a distal portion of the wall structure is segmented and progressively malleable.
    [0014]
    14. Guide catheter according to claim 1, characterized by the fact that it additionally comprises: a free floating coil (160) constricted in an external wall of the wall structure.
    [0015]
    15. Guide catheter, according to claim 1, characterized by the fact that it still comprises: an elongated stiffener (64) in the external lumen.
    [0016]
    16. Guide catheter according to claim 15, characterized by the fact that the elongated stiffener varies in stiffness along its length, or tapers over at least a portion of its length.
    [0017]
    17. Guide catheter according to claim 16, characterized by the fact that the elongated stiffener (140) tapers, in which the length portion of the elongated stiffener has a tapering angle that changes continuously or has tapered segments contiguous with different tapering angles.
    [0018]
    18. Guide catheter according to claim 1, characterized in that it additionally comprises a balloon (165) disposed along an exterior of the elongated wall structure of the guide catheter, in which the external lumen is an inflammation lumen tion / deflation for the balloon.
    [0019]
    19. Guide catheter according to claim 1, characterized by the fact that it still comprises a metal cage arranged along an exterior of the elongated wall structure of the guide catheter, and control wires housed within the expanding lumen / retract the metal cage.
    [0020]
    20. Guide catheter according to claim 1, characterized in that the layer or segment (177) of the wall structure of the guide catheter comprises a material that can be activated so that at least one characteristic of the material changes .
    [0021]
    21. Guide catheter according to claim 20, characterized by the fact that the layer or segment of the wall structure is able to change in response to the injection of a liquid inside the external lumen, or the insertion of an element electric heater (180) inside the outer lumen.
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    法律状态:
    2017-03-14| B25A| Requested transfer of rights approved|Owner name: DEPUY SYNTHES PRODUCTS, LLC (US) |
    2017-10-10| B03A| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]|
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2020-07-28| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2020-11-24| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-01-26| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/04/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/088,314|2011-04-15|
    US13/088,314|US8721588B2|2011-04-15|2011-04-15|Noncircular inner lumen guiding catheter with assisted variable support|
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