Articulating catheter with a discontinuous reinforcement layer

Abstract

A dual-anchor steerable catheter for use in neurovasculature and other areas of a human body, and a method of manufacture, are disclosed. The device comprises first and second pull rings for deflecting multiple portions of the shaft to form various shapes suitable for navigating tortuous anatomy. Modifications to the reinforcement layer allow space for pull rings between the inner and outer walls of the shaft, thereby accommodating diameter requirements for neurovascular applications. A reduction in the reinforcement layer allows for a pull ring to be positioned within the shaft wall, without exceeding a predetermined outer diameter required for neurological applications and without compromising pushability or torquability of the device. One modification includes a discontinuous reinforcement layer to allow space for a pull ring and also maximize inner diameter and minimize outer diameter.

Description

ARTICULATING CATHETER WITH A DISCONTINUOUS REINFORCEMENTLAYERTECHNICAL FIELD

[0001] The disclosure relates to medical device construction, and more particularly to shaft reinforcement and pull ring assembly for an articulating catheter.BACKGROUND OF THE ART

[0002] For neurological procedures, physicians typically use a combination of diagnostic and guiding catheters that come in a variety of shapes to maneuver through vasculature. Selecting an appropriate diagnostic shape prior to a procedure can be challenging due to varying patient anatomies. Certain anatomies pose more challenges than others, including type III aortic arches, bovine arches, and tortuous vessels. The complexity of neurovascular anatomy can make accessing specific arteries difficult.

[0003] Steerable sheaths and steerable catheters are used to maneuver through human vasculature and access difficult to reach blood vessels. However, existing steerable devices are difficult, or even impossible, to navigate through tortuous anatomy, specifically the vessels within the neurovasculature. Certain mechanical properties (pushability, torquability, lubricity, etc.) must be optimized in order to navigate through the tortuous anatomy, and must conform to size limitations, both for inner and outer diameters.

[0004] Steerable sheath construction typically includes forming a series of layers into an elongated shaft. One of those layers includes a reinforcing layer such as a metal braid. Pull rings are embedded within the walls of the shaft in order to deflect one or more portions of the shaft using pull wires. Shaft construction is relatively easier for larger sized steerable sheaths when there is more space between the inner and outer walls to insert a pull ring, a pull wire, and a metal braid. As the outer diameter requirements get smaller,the challenges increase as there is less space to add the components between the layers, while maintain certain inner diameters. Medical devices used in neurological applications must have certain outer diameter limitations to navigate the neurovascular vessels and must have a certain inner diameter in order to accommodate treatment devices. Such restrictions can lead to little space between the device’s inner and outer walls.

[0005] It would be advantageous for an articulating catheter to have a shaft design that allows room within the shaft wall for components while maintaining the required inner and outer diameters needed for neurovascular procedures.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] In order that the invention may be readily understood, embodiments of the invention are illustrated by way of examples in the accompanying drawings, in which:

[0007] FIG. 1 is an illustration of a catheter access system for facilitating advancement of treatment devices for neurological procedures, in accordance with an embodiment of the present invention;

[0008] FIG. 2A is an illustration of an articulating catheter in accordance with an embodiment of the present invention;

[0009] FIG. 2B is an illustration of the distal region of the articulating catheter of FIG. 2 A, in accordance with an embodiment of the present invention;

[0010] FIG. 2C is a cross-sectional illustration of a portion of the articulating catheter in accordance with an embodiment of the present invention;

[0011] FIG. 2D is an illustration showing pull wires and pull rings within the articulating catheter, in accordance with an embodiment of the present invention;

[0012] FIGS. 3A to 3E show steps of assembling layers of the articulating catheter in accordance with an embodiment of the present invention;

[0013] FIG. 4A is an illustration of a portion of the reinforcing layer in accordance one embodiment of the present invention;

[0014] FIG. 4B is an illustration of a portion of the reinforcing layer in accordance with an alternative embodiment of the present invention;

[0015] FIG. 5A is an illustration showing a discontinuous reinforcement layer in accordance with an embodiment of the present invention;

[0016] FIG. 5B is an illustration showing a discontinuous reinforcement layer in accordance with an alternative embodiment of the present invention;

[0017] FIG. 6 is an illustration of an articulating catheter shaft comprising zones of varying stiffnesses in accordance with an embodiment of the present invention;

[0018] FIG. 7 is an illustration of the shaft comprising hypotubes used as pull mechanisms in accordance an alternative embodiment of the present invention;

[0019] FIGS. 8A(i) to 8D are illustrations of curved configurations of the articulating catheter in accordance with an embodiment of the present invention;

[0020] FIG. 9 is an illustration of the articulating catheter aiming towards a target blood vessel in tortuous anatomy in accordance with an embodiment of the present invention;

[0021] FIG. 10 is an illustration of a pull mechanism in accordance an embodiment of the present invention;

[0022] FIG. 11A is an illustration of a secondary catheter in accordance with an embodiment of the present invention; and

[0023] FIG. 11B is an illustration of a secondary catheter in accordance with an alternative embodiment of the present invention.

[0024] In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead being placed upon generally illustrating the various concepts discussed herein.DETAILED DESCRIPTION

[0025] Human neurovascular anatomy can be difficult to navigate because of its tortuous nature. There are numerous neurovascular procedures that require advancing treatment devices though this anatomy. Some examples of such procedures include the following: the treatment of acute ischemic stroke, endovascular coil embolization, treating arteriovenous malformations, a cerebral venous sinus thrombosis procedure, and carotid angioplasty and stenting. The devices, systems, and methods described herein may be used for, but are not limited to, any of the procedures described above.

[0026] The inventors have developed novel solutions to access the neurovascualture and deliver treatment devices. More specifically, the inventors have developed an articulating catheter with a discontinuous reinforcement (braid) layer that allows space for pull rings and other components to within the shaft wall, and achieve the required inner and outer diameters needed for neurovascular procedures. A method of manufacturing said articulating catheter is also disclosed herein. The inventors have further developed a kit that includes an articulating catheter, and a secondary catheter designed to work the articulating catheter. The kit streamlines complex neurovascular interventions by minimizing exchanges and reducing procedure time.

[0027] In one broad aspect, embodiments of the present invention comprise an articulating catheter comprising: an elongate member having a distal segment and a proximal segment, the elongate member comprising a plurality of layers including areinforcement layer extending substantially from the distal segment to the proximal segment, the elongate member defining at least one interrupted region where the reinforcement layer is discontinuous; a first pull wire coupled to a first pull mechanism; and a second pull wire coupled to a second pull mechanism; applying tension to the first pull wire causes the elongate member to adopt a first curve in a first portion of the elongate member, and applying tension to the second pull wire causes the elongate member to adopt a second curve in a second portion of the elongate member; and at least one of the first or second pull mechanisms is located within the at least one interrupted region.

[0028] As a feature of this aspect, the first pull mechanism is located within the distal segment and the second pull mechanism is located within the at least one interrupted region.

[0029] As a feature of this aspect, the reinforcement layer comprises a braid.

[0030] As a feature of this aspect, the braid has a first configuration in the at least one interrupted region and a second configuration in the distal segment and the proximal segment.

[0031] As a feature of this aspect, the first configuration of the braid in the at least one interrupted region comprises a single braid pattern and the second configuration of the braid in the distal segment and proximal segment comprises a double braid pattern.

[0032] As a feature of this aspect, the reinforcement layer comprises a first reinforcement structure in the distal segment and a second reinforcement structure in the proximal segment.

[0033] As a feature of this aspect, the first and second reinforcement structures are each selected from the group consisting of a braid, a coil, and a hypotube.

[0034] As a feature of this aspect, the elongate member has a first interrupted region and a second interrupted region where the reinforcement layer is discontinuous, and thefirst pull mechanism is located within the first interrupted region and the second pull mechanism is located within the second interrupted region.

[0035] As a feature of this aspect, the reinforcement layer comprises a braid.

[0036] As a feature of this aspect, the braid has a first configuration in each of the first interrupted region and the second interrupted region, and a second configuration in each of the distal segment and the proximal segment.

[0037] As a feature of this aspect, the first configuration of the braid in at least one of the first interrupted region or the second interrupted region comprises a single braid pattern and the second configuration of the braid in the distal segment and proximal segment comprises a double braid pattern.

[0038] As a feature of this aspect, the first interrupted region is distal to the second interrupted region, and the reinforcement layer comprises a first reinforcement structure distal to the first interrupted region, a second reinforcement structure located between the first and second interrupted regions, and a third reinforcement structure proximal to the second interrupted region.

[0039] As a feature of this aspect, the first, second, and third reinforcement structures are each selected from the group consisting of a braid, a coil, and a hypotube.

[0040] As a feature of this aspect, the articulating catheter further comprises a plurality of stiffness zones.

[0041] As a feature of this aspect, at least one of the first and second pull mechanisms comprises a pull ring.

[0042] As a feature of this aspect, at least one of the first and second pull mechanisms comprises a hypotube.

[0043] As a feature of this aspect, the articulating catheter further comprises a control hub operatively coupled to the proximal segment of the elongate member.

[0044] As a feature of this aspect, the control hub comprises a first actuator for controlling tension in the first pull wire and a second actuator for controlling tension in the second pull wire.

[0045] As a feature of this aspect, the control hub comprises at least one locking mechanism for locking at least one of the first and second actuators.

[0046] As a feature of this aspect, the control hub comprises a first locking mechanism for locking the first actuator and a second locking mechanism for locking the second actuator.

[0047] In another broad aspect, embodiments of the present invention comprise an articulating catheter comprising: an elongate member defining a distal segment and a proximal segment, the elongate member comprising a plurality of layers including a reinforcement layer extending substantially from the distal segment to the proximal segment, the elongate member further defining at least one interrupted region where the reinforcement layer is discontinuous; and a deflection mechanism comprising a pull mechanism, the pull mechanism being located within the interrupted region; and applying tension to the deflection mechanism causes the elongate member to adopt a curve in a portion of the elongate member.

[0048] In another broad aspect, embodiments of the present invention comprise a kit comprising: the articulating catheter disclosed herein; and a secondary catheter, sized to be received within the articulating catheter; while the secondary catheter is received within the articulating catheter, articulation of the articulating catheter is unimpeded.

[0049] In another broad aspect, embodiments of the present invention comprise an articulating catheter comprising: a shaft having a proximal segment, a distal segment, and an intermediate segment located between the proximal segment and the distal segment, theshaft comprising a reinforcement layer, the reinforcement layer comprising a plurality of reinforcement members; a first reinforcement member of the plurality of reinforcement members extending from the proximal segment to the distal segment; a second reinforcement member of the plurality of reinforcement members extending within the proximal segment and terminating therein; a third reinforcement member of the plurality of reinforcement members extending within the distal segment and terminating therein; and a pull ring coupled to a pull wire, the pull ring located within the intermediate segment.

[0050] As a feature of this aspect, the first and second reinforcement members cooperatively form a first pattern in the proximal segment, and the first reinforcement member forms a second pattern in the intermediate segment; and the first and third reinforcement members cooperatively form a third pattern in the distal segment

[0051] As a feature of this aspect, the first and third patterns comprise the same pattern.

[0052] As a feature of this aspect, the first and third patterns comprise a braid pattern.

[0053] As a feature of this aspect, the second pattern comprises a coil pattern.

[0054] As a feature of this aspect, the plurality of reinforcement members comprises at least one flat wire and at least one round wire.

[0055] As a feature of this aspect, the first reinforcement member comprises a flat wire and the second and third reinforcement members comprise round wires.

[0056] In another broad aspect, embodiments of the present invention comprise an articulating catheter comprising: a shaft having a proximal segment, a distal segment, and an intermediate segment located between the proximal segment and the distal segment, the shaft comprising a reinforcement layer, the reinforcement layer comprising a plurality of reinforcement members; and a pull ring coupled to a pull wire, the pull ring located within the intermediate segment; at least two reinforcement members of the plurality of reinforcement members cooperatively form a first pattern in the proximal segment, and atleast one reinforcement member forms a second pattern in the intermediate segment; and at least two reinforcement members of the plurality of reinforcement members cooperatively form a third pattern in the distal segment

[0057] As a feature of this aspect, the first and third patterns comprise the same pattern.

[0058] As a feature of this aspect, the first and third patterns comprise a braid pattern.

[0059] As a feature of this aspect, the second pattern comprises a coil pattern.

[0060] In another broad aspect, embodiments of the present invention comprise a method of assembling an articulating catheter shaft, the articulating catheter shaft comprising a shaft having a proximal segment, a distal segment, and an intermediate segment located between the proximal and distal segments, the method comprising the steps of: applying a first layer to a mandrel; overlaying a reinforcement layer onto the first layer, the reinforcement layer comprising a plurality of reinforcement members forming a first pattern; removing a portion of at least one reinforcement member, thereby creating the intermediate segment; and adding at least one pull ring within the intermediate segment; the reinforcement layer in the intermediate segment comprises at least one reinforcement member forming a second pattern, the second pattern being different from the first pattern.

[0061] As a feature of this aspect, the proximal segment and distal segments comprise a braid pattern and the intermediate segment comprises a coil pattern.

[0062] With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of certain embodiments of the present invention only. Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to beunderstood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0063] FIG. 1 shows a system which can be used in one or more of the neurovascular procedures described herein. In one embodiment, catheter access system 1000 includes a plurality of elongate / elongated medical devices including an articulating catheter 100, a secondary catheter 200, a guidewire 300, and a dilator 500. Articulating catheter 100 may also be referred to as “steerable catheter” or “anchoring catheter” and will be described in greater detail herein.

[0064] Catheter access system 1000 is configured to be compatible with other treatment devices which can be used as part of an overall procedure to treat a neurological condition. Treatment devices include, but are not limited to, a stent retriever, an aspiration catheter, a microwire, a microcatheter, an intermediate catheter, a distal access catheter, other wires, other catheters, devices for delivering embolic agents, flow diverters, or other implantable devices.

[0065] In one embodiment, secondary catheter 200 may be similar to commonly known flexible diagnostic catheters and will be described in more detail herein.

[0066] In one embodiment, guidewire 300 may be any guidewire or wire guide, known by those skilled in the art, for example a flexible wire having a 0.035” or 0.038” outer diameter. Guidewire 300 may have a range of properties including various stiffness properties or distal shapes, for example straight, curved, angled.

[0067] In one embodiment, dilator 500 may be any commonly known dilator used in interventional radiology. Dilator 500 is compatible with articulating catheter 100 and can be used at the beginning of the procedure to facilitate delivering the components of the catheter access system 1000 into the patient.

[0068] In one embodiment, articulating catheter 100 comprises two or more deflection mechanisms, for example, one located at or near the distal end and one proximal to thedistal end. These mechanisms facilitate forming multiple curve shapes and adapting to various diagnostic catheter shapes to aid vessel selection. In some embodiments, articulating catheter 100 comprises a single deflection mechanism.

[0069] The deflection mechanisms (also referred to as “anchoring mechanisms”) provide stability, enabling smooth advancement of the secondary catheter 200 through tortuous anatomy. Articulating catheter 100 is also configured to “track” over secondary catheter 200 to be advanced through tortuous anatomy. Finally, the anchoring mechanisms provide bracing to maintain the position of the articulating catheter 100 throughout the procedure. In some embodiments, either or both of articulating catheter 100 and secondary catheter 200 may comprise a hydrophilic coating to facilitate advancement through tortuous vessels. The hydrophilic coating may be applied to the entire shaft, or one or more portions of the shaft, for example a distal region.

[0070] Referring to FIGS. 2 A to 2D, according to one embodiment of the present invention, articulating catheter 100 has a distal end 102, a proximal end 104, and includes a shaft 106 comprising inner wall 108a and outer wall 108b. Inner wall 108a defines a lumen 110, also referred to as “primary lumen”, which terminates at distal opening (shown in FIG. 2B). Shaft 106 comprises a distal region 114 and a proximal end 116. The distal end of shaft 106 corresponds to distal end 102.

[0071] In one embodiment, articulating catheter 100 further comprises a control hub 118 located at proximal end 104. In some embodiments the control hub 118 is a handle. Shaft proximal end 116 is coupled to control hub 118. In one embodiment, control hub 118 comprises one or more actuators 120, and a hub 122. Actuator 120 may be a commonly known device such as a lever, wheel, knob, or a slider. Actuator 120 is coupled to one or more deflection mechanisms and can be manipulated to control a deflection in a portion of shaft 106. In some embodiments, hub 122 may be a luer connection, a hemostatic valve, or other known mechanism used to receive an inner device, for example, secondary catheter 200, guidewire 300, or a treatment device, through lumen 110 such that the inner device can move through primary lumen 110 and exit at distal opening. In other embodiments, aseparate valve (not shown) is configured to connect to an opening on the control hub 118 / proximal end 104. In one example, the separate valve is a rotating hemostatic valve.

[0072] Typical steerable sheath / steerable catheter construction includes an actuator, a pull wire, and a pull ring. The pull wire runs along the length of the catheter shaft, and a distal end is coupled to a pull ring which is affixed to or embedded within the shaft. A proximal end of the pull wire is coupled to an actuator on a control hub. When actuated, tension is applied to the pull wire and shaft 106 deflects or curves in a region near the pull ring, creating a deflection region. In other words, a portion of the shaft adopts a curved configuration.

[0073] FIG. 2C shows a cross section of shaft 106 taken along line A-A in FIG. 2B. In one embodiment, wire lumens 126a, 126b are located radially below reinforcing layer 162. In another embodiment, wire lumens 126a, 126b are located radially above reinforcement layer 162. In other embodiments, wire lumens 126a, 126b may be anywhere between inner wall 108a and outer wall 108b. In one embodiment, wire lumens 126a and 126b are spaced substantially 180 degrees apart. In other embodiments, the radial distance between wire lumens 126a and 126b may be any other radial distance, for example offset by 90 degrees, 135 degrees, or any other distance to obtain various curved shapes. In one embodiment, shaft 106 comprises a plurality of layers 160, for example three layers 160, 162, 164. Layers 160, 162 and 164 will be described in greater detail below.

[0074] With reference to FIG. 2D, in one embodiment, articulating catheter 100 defines two wire lumens (not shown) located between inner wall 108a and outer wall 108b. Articulating catheter 100 comprises two deflection mechanisms (or “anchoring mechanisms”). In one embodiment, a deflection mechanism includes a pull wire 128 coupled to a pull ring 130. In one example, pull wires 128 are laser welded to pull rings 130. In some embodiments, pull wires 128 are flat. In another embodiment, pull wires 128 are round, i.e., a circular cross section.

[0075] In one example, articulating catheter 100 comprises pull wire 128a coupled to pull ring 130a and pull wire 128b coupled to pull ring 130b. Pull wires 128a and 128b extend along the shaft through wire lumens 126a and 126b. Pull ring 130a may be referred to as “proximal” pull ring and pull ring 130b may be referred to as “distal” pull ring. Each portion of the shaft comprising a pull ring defines a deflectable region. In such an embodiment, articulating catheter 100 comprises proximal deflection region and distal deflection region. In some embodiments, deflection regions and are not necessarily in alignment with pull rings 130a, 130b, and in some examples are located substantially proximal to pull rings 130a, 130b b. As used herein, deflection mechanisms may be described as being “activated” or “actuated” when tension is applied to the deflection mechanism pull wire. Similarly, “deactivating” a deflection mechanism means releasing tension from the pull wire.

[0076] In one embodiment, distal pull ring 130b is located substantially at device distal end 102. In another embodiment, distal pull ring 130b is located a distance from the distal end 102. The portion of shaft 106 from distal end 102 to the distal pull ring 130b may be rigid or flexible.Methods of assembly of layers

[0077] In one embodiment, shaft 106 comprises a plurality of layers. The construction of the shaft layers is illustrated in FIGS. 3A to 3F.

[0078] As shown in FIG. 3 A, a first layer 160 (also referred to as “inner layer”) is placed on a mandrel 302. In one example, first layer 160 comprises a lubricious polytetrafluorethylene “PTFE” (or similar material). In other examples, first layer 160 comprises nylon, polyethylene, polyethylene terephthalate “PET”, polyvinyl chloride “PVC”, fluorinated ethylene propylene “FEP”, or polyimide.

[0079] Referring to FIG. 3B, a second layer 162, (also referred to as “reinforcing layer” or “reinforcement layer”) is disposed over first layer 160. In one embodiment, two secondary mandrels 304a and 304b are disposed above first layer 160 and below secondlayer 162. In another embodiment, secondary mandrels 304a and 304b are disposed over second layer 162. (NOTE: in the figures, only one secondary mandrel is shown). Secondary mandrels 304a, 304b are used to form wire lumens 126a and 126b.

[0080] In one embodiment, reinforcing layer 162 comprises a braid 170, for example a metal braid, and extends from the (shaft) distal end 102 to the shaft proximal end 116. In other examples, braid 170 comprises nitinol, stainless steel, or another similar material. In other embodiments, second layer 162 comprises multiple reinforcement structures, described herein, for example one or more braids, coils, hypotubes, or any combination thereof.

[0081] Typical steerable sheath construction usually comprises the step of placing pull rings over the reinforcement layer 162. As will be described in detail below, in one embodiment of the present invention, a portion of reinforcement layer 162 is removed to make space for the pull rings, though this is not shown in FIGS. 3B or 3C.

[0082] Referring to FIG. 3C, a third layer 164 (also referred to as “outer layer”, “segmented layer”) is disposed over second layer 162. In one embodiment, segmented layer 164 comprises of a plurality of smaller “reflown” segments having varying rigidity / stiffness properties. In one example, segmented layer 164 comprises segments 164a, 164b, 164c, 164d, and 164e.

[0083] In one example, segments 164a to 164e comprise poly ether block amide “PEBA” 35D, 42D, 55D, 63D, 72D, or nylon 12. Any segments may be placed on shaft 106 in any order, in any combination, to create various configurations having different mechanical properties. Example combinations of lengths and stiffness properties are described herein.

[0084] In addition to the segments, two spacers (not shown) are disposed over second layer 162, in line with segmented layer 164. Spacers are placed on the shaft temporarily and are used to create spaces for the pull rings 130a, 130b. Segmented layer 164 is then treated with heat to form a continuous layer, and spacers are removed. The secondarymandrels 306a, 306b are removed, leaving behind wire lumens 126a, 126b. The spaces created allow access to the wire lumens, formed by secondary mandrels. Pull rings 130a and 130b are then added, as shown in FIG. 3D. The pull rings are affixed to pull wire, for example by welding.

[0085] Referring to FIG. 3E, additional segments having lengths approximately equal to the pull rings / spacers are placed over the pull rings, and the segmented layer is treated again to form into a continuous outer layer 164. (NOTE: pull rings as shown as dashed lines in FIG. 3E) In other examples, outer layer 164 comprises a polyimide dip coat or a thermosplastic polyurethane “TPU” dip coat.

[0086] In other embodiments, shaft 106 has a lubricious layer, for example a hydrophilic or hydrophobic polymer (not shown). In one specific embodiment, a distal region of the shaft has a hydrophilic coating, for example, the distal 10-20cm. In another embodiment, portions of the shaft may have both hydrophobic and / or hydrophilic coatings.

[0087] While not shown in a flow chart, the method of manufacturing comprises the steps of i) applying the first layer 160 to the mandrel, ii) adding the second layer 162 over the first layer 160, iii) modifying the second layer 162, for example by removing a portion, iv) adding one or more pull rings 130 at the location where the second layer 162 was modified, and v) adding the third layer 164. Steps iv) and v) may be carried out at the same time, or portions of the third layer 164 may be added first, then the pull rings 130, then more segments of third layer 164, as would be known to one skilled in the art.Discontinuous Reinforcement Laver

[0088] As the shaft 106 outer diameters is reduced and / or inner diameter is increased, to create space for a pull ring to be placed between the inner and outer walls 108a, 108b, in one embodiment, the elongate member includes at least one interrupted region where the reinforcement layer 162 is discontinuous. In other words, there is a discontinuity in reinforcement layer 162, which may be a complete break, creating two separate elements, or the reinforcement layer 162 has a change in material properties in that region, asdescribed herein. The interrupted region can allow more space (between the inner and outer walls) for a pull ring 130.

[0089] The variation in structure could include removing part of the reinforcement layer, for example removing some material from a metal braid, shown in FIG. 4A, or could include removing a section of the braid entirely as shown in FIG. 4B. In some embodiments, shaft 106 comprises a plurality of reinforcement structures separated by spaces, (or linear distances), such that the shaft 106 defines one or more interrupted regions where the reinforcement structure / reinforcement layer is discontinuous.

[0090] FIG. 4A shows an interrupted region 142 where the configuration of the reinforcement layer 162 in that region is different than in the remainder of the shaft. Specifically, the interrupted region 142 comprises a metal braid having a single braid pattern, and the remainder of the shaft comprises a double braid pattern.

[0091] FIG. 4B shows an interrupted region 142 where the metal braid has been removed entirely. In either embodiment, a portion of one of the mandrels 304 may be removed within interrupted region 142 in order to create space for a pull mechanism.

[0092]

[0093] Referring to FIG. 5 A, in one embodiment, reinforcing layer 162 comprises an interrupted region 142 such that there are two or more separate reinforcement structures separated by a linear distance. Shaft 106 defines three segments 140a, 140b, and 140c, having lengths L2, L3, and L4 respectively. In one example embodiment, discontinuous reinforcement layer 162 includes a first braid 170a and a second braid 170b, located within segments 140a and 140c respectively. Segment 140b defines interrupted region 142. (Note, for clarity, interrupted region 142 is an intermediate region located between a distal region and a proximal region)

[0094] The discontinuous reinforcement layer 162 may be formed by placing two separate reinforcement structures on the first layer 160. Alternatively, a singlereinforcement structure may be formed as described herein (as shown in FIG. 3B), and then a portion of the structure (segment 140b) may be modified to remove some or all of the structure within that portion. The modification may be done before or after the third layer 164 is overlaid on the second layer 162.

[0095] In another embodiment, segment 140b comprises a reinforcement structure with a different configuration, for example a braid having a different configuration / pattern than braids 170a, 170b. In one specific example, braids 170a, 170b have a double braid pattern, and the interrupted region 142 comprises single braid pattern, shown in FIG. 4A. Single braid section may also be referred to as “half braid” section or “coiled” section. In other words, it is a braid pattern with one layer removed. In such examples, braid 170c has a smaller diameter than braids 170a, 170b, thus allowing a proximal pull ring 130a to be placed within interrupted regionl42.

[0096] Referring to FIG. 5B, in another embodiment, shaft 106 includes first, second, third, fourth, and fifth segments 140a, 140b, 140c, 140d, 140e, having lengths L2, L3, L4, L5, and L6 respectively. Shaft 106 comprises three reinforcement structures, for example, braids 170a, 170b, 170c, separated by two interrupted regions 142a and 142b. In such an embodiment, pull mechanisms may be placed segments 140b and 140d.

[0097] In some embodiments, the reinforcement structures are separate structures placed over the first layer 160. In other embodiments, a single reinforcement structure may be modified, for example cut up or have sections cut away to form less-reinforced regions / non-reinforced regions to make room for pull mechanisms.

[0098] In some embodiments, reinforcement structures comprise metal braids, coils, hypotubes, or any combination thereof, as described herein.

[0099] Referring again to FIG. 4A, in one embodiment, the reinforcement layer 162 comprises a braid 170 formed from a plurality of reinforcement members, for example a plurality of metal wires forming a metal braid. In some embodiments, the reinforcement members are interwoven in a braid pattern shown at 170a and 170b. When a portion of oneor more reinforcement members is removed, there is a second pattern formed, as shown at 170c, for example a coil pattern. The wires may be round wires or flat wires, or any combination of round and flat wires, or any other suitable shape.

[0100] In other words, at least one reinforcement extends from the proximal segment to the distal segment. There is a second reinforcement member in the proximal segment, and a third reinforcement member in the distal segment. This first reinforcement member, cooperatively with a second reinforcement member in the proximal segment forms a first pattern. The first reinforcement member forms a second pattern in the intermediate segment. The first reinforcement member, cooperatively with the third reinforcement member, forms a third pattern in the distal segment. In one embodiment, the first and third patterns are the same.

[0101] In such an embodiment, there is at least one continuous reinforcement member extending from the proximal segment to the distal segment which provide advantageous mechanical properties compared to the embodiment shown in FIG. 4B that has a portion of the braid completely removed. By having at least one reinforcement member extending from the proximal segment to the distal segment, beneficial pushability and torquability characteristics can be retained.

[0102] Such a configuration can be used for multiple pulls wires and pull rings, for example two pull wires and two pull rings. In other embodiments, for a double pull ring double articulating, (not shown), but similar to FIGS. 4A and 5B, shaft 106 maybe have two interrupted regions, and each interrupted region may have a first pattern, and the other regions may have a second pattern. For example, three braid patterns and two coil patterns, (braid-coil-braid-coil-braid) with at least one reinforcement member extending from the proximal end to the distal end and forming part of all five patterns, and at least three other reinforcement members, cooperatively with the first reinforcement member, forming the proximal segment braid, the distal segment braid, and the intermediate segment braid (similar to what is shown in FIG. 5B).

[0103] In other embodiments, the reinforcement layer 162 comprises multiple wires (greater than three), for example a plurality of wires extending from the proximal segment to the distal segment, and a plurality of wires in each of the proximal and distal segments. A plurality of wires form the coiled pattern in the intermediate segment and a plurality of wires cooperatively form braid patterns in the proximal and distal segments.Stiffness Zones

[0104] According to one embodiment of the present invention, shaft 106 comprises a plurality of stiffness regions 115 (or “zones”), having varying flexibility / rigidity, extending along shaft 106. Referring to FIG. 6, in one embodiment, shaft 106 comprises stiffness regions 115a, 115b, 115c, 115d, 115e, 115f, 115g, having lengths Li l, LI 2, LI 3, LI 4, LI 5, LI 6, LI 7. Each stiffness region has a distal end and a proximal end. Stiffness region 115g extends from the proximal end of stiffness region 115f to the shaft proximal end 116. Each region has its own flexibility / rigidity properties, measured in durometer (“D”) compared to the other regions. In one embodiment, distal pull ring 130b is located in stiffness region 115a (at distal end 102) and proximal pull ring 130a is located in zone 115c. In one specific embodiment, each pull ring 130a, 130b is 3 mm long, and the stiffness properties of that region correspond to the stiffness / rigidity properties of the pull ring. Durometers of the zones range from about 35D to about 72D.

[0105] Lengths, 115a and 115c, from between about 2 mm to about 4 mm, 115b from between about 24 mm to 43 mm, 115d from between about 50 mm to 97 mm, e and f from between about 5 mm to about 13 mm, and 115g is the remaining length to the proximal end.

[0106] In one embodiment, reinforcing layer 162 extends from shaft proximal end 116 to the proximal pull ring 130a, and in zone 115b, and in some embodiments in zone 115r. In other words, zones 115a and 115c include the interrupted regions where the reinforcement layer is discontinuous. In some embodiments, zone 115g comprises a high- performance polymer.Alternative Reinforcement Structures / Configurations

[0107] In another embodiment of the present invention, articulating catheter 100 comprises shaft 106 that includes a braid and coil design. The construction is similar to what was described above with reference to FIGS. 3 A to 3E, but with a different reinforcing layer 162. Shaft 106 comprises a first layer 160, previously described herein, which is placed on a mandrel, and two secondary mandrels and placed over first layer.

[0108] In one example, reinforcing layer 162 comprises two reinforcement structures, including a (metal) braid and a coil. In some embodiments, a proximal end of coil is coupled to the distal end of braid.

[0109] In one embodiment, one secondary mandrel extends from the shaft proximal end 116 to a region near the proximal end of coil and distal end of braid. Another secondary mandrel extends to a region near the distal end of coil. As described above, secondary mandrels are used to form wire lumens. Braid is placed over the mandrels and over first layer and extends from shaft proximal end to the proximal end of coil. In some embodiments, a space between the two reinforcement structures defines the interrupted region. In one embodiment, distal pull ring is distal to coil, and proximal pull ring is proximal to coil.

[0110] In another embodiment, shaft 106 comprises reinforcing layer 162 that comprises two reinforcement structures including braid 170 and hypotube. Hypotube is applied in the same manner as described above for coil. In some embodiments, a space between the two structures defines an interrupted region.

[0111] In one embodiment, distal pull ring is distal to hypotube, and proximal pull ring is proximal to hypotube. Secondary mandrels pull wire lumens may be underneath or on top of hypotube.

[0112] In another embodiment, shaft 106 comprises reinforcing layer 162 that includes braid and multiple hypotubes. Shaft 106 includes a first hypotube and second hypotube.Braid covers the remaining (proximal) portion of shaft 106, extending from first hypotube to the shaft proximal end 116. Proximal and distal pull rings are located distal to first and second hypotubes respectively.

[0113] In other embodiments, shaft 106 reinforcing layer 162 includes a coil extending the length of the shaft 106. In other words, coil extends from distal end 102 to shaft proximal end 116. Pull rings 130a, 130b may be placed between portions of the coil or may be located in interrupted regions where the coil has been modified and / or had sections removed, in other words discontinuous. In some embodiments reinforcing layer 162 comprises two coils, separated by an interrupted region.

[0114] In another embodiment, shaft 106 reinforcing layer 162 includes one or more hypotubes extending the length of shaft 106. In one embodiment, a single hypotube extends from distal end 102 to shaft proximal end 116. In one example, the one or more hypotubes comprise a plurality of laser cut patterns, for example, an interrupted cut in a proximal region and a hinge cut pattern in a distal region.Alternative Deflection Mechanisms

[0115] According to another embodiment of the present invention, one or more deflection mechanisms include a component different from a pull ring 130. For example, instead of a pull ring, one of the reinforcement structures described herein, such as a coil or a hypotube, may be used. In other words, pull wires 128 may be affixed to one or more reinforcement structures. In some embodiments, the shaft may include any combination of braid, pull ring, coil, or hypotube as reinforcement structures.

[0116] With reference to FIG. 7, in one embodiment, pull wires 128a and 128b are coupled to hypotubes 148a and 148b respectively. Each of hypotubes 148a, 148b, may be oriented in a way to facilitate bending in a desired direction, for example a laser cut patterns offset by 180 degrees. Hypotube 148 may have any configuration or laser cut pattern known to those skilled in art.

[0117] In an alternative embodiment, shaft 106 includes proximal coil a and distal coil. Pull wires are coupled to distal ends of coils respectively. In some examples, the pull wires are laser welded to the coils. The remainder of the shaft construction is similar to what is described above for FIGS. 3 A to 3E. In some embodiments, braid 170 covers the proximal portion of the shaft, i.e., extending from the proximal end of the shaft 106 to the proximal coil.

[0118] Either embodiment described herein may include a braid 170 in the proximal region, in other words, extending from the proximal end of the proximal deflection mechanism to the shaft proximal end 116. In such embodiments, flexibility / rigidity properties can be varied along the length of the shaft. In some embodiments, braid 170 may extend to the distal end 102, and deflection mechanisms (coil or hypotube) may be placed over the braid 170. In either embodiment, one or more pull mechanisms may be located in interrupted regions 142 along shaft 106, for example where is no braid 170 or a reduced braid 170, as described herein.

[0119] In some embodiments, the distal deflection mechanism is located substantially at device distal end 102. In other embodiments, the distal deflection mechanism is located a distance from the distal end 102.Deflection Regions

[0120] In one embodiment, articulating catheter 100 is configured such that shaft 106 can adopt a double curve or “S-shaped” curve. S-shaped curve means a first curve in a first deflection region and second curve in a second deflection region, the second curve in a generally opposite direction to the first curve, as shown in FIG. 8D. In one embodiment, both curves share a common plane. In other embodiments, the first and second curves are in two different planes, for example, perpendicular to each other. In some embodiments, the radius of the first curve is different than the radius of the second curve. In some embodiments, the curves are not generally in opposite directions.

[0121] The deflectable regions / curved regions may also be referred to as “anchor points”, and, in some embodiments, the rigidity at an anchor point increases when the shaft is curved in that region. The increased rigidity aids in bracing the device such that it supports advancement of an inner device therethrough.

[0122] In one embodiment, articulating catheter 100 comprises two actuators, 120a, 120b, (not shown) each actuator configured to tension a single pull wire, e.g., pull wire 128a, 128b respectively. Actuator(s) 120 may be a lever, slider, a rotary knob, a wheel, or other known mechanism used on steerable devices. In such an embodiment, each anchor point / deflection region is controlled independently. In another embodiment, pull wires 128a and 128b are controlled by a single actuator 120.

[0123] In further embodiments (not shown), articulating catheter 100 may comprise two pull rings, two actuators, and four pull wires running through four wire lumens, where each pull ring connected to one actuator via two pull wires. In still further embodiments, articulating catheter 100 has additional pull rings to allow multiple curved portions of the shaft, for example three or more deflection regions allowing for three or more curves. In one embodiment, a third deflection region (not shown) is located proximal to first deflection region 151.

[0124] In some embodiments, articulating catheter 100 comprises one or more locking features / locking mechanisms (not shown), in order to lock the device in one or more curved configurations. Locking features may be located on the control hub, and may use any known mechanism, for example a brake shoe, a switch, a push button, or a spring-loaded feature. Locking features may also comprise an auto-lock feature, where a push button must be depressed in order for shaft to deflect or return to the undeflected state.

[0125] In some embodiments, articulating catheter 100 comprises radiopaque features (not shown) that allow the portions of shaft 106 to be viewed under various known imaging modalities. Radiopaque features can include one or more marker bands, for example platinum iridium, located anywhere along shaft 106. In other embodiments, one or morelayers comprises a radiopaque filler that may provide visibility under fluoroscopy. In one example, the radiopaque filler is a high concentration of BaSO4. In some examples, the shaft comprises Bismuth or Tungsten.

[0126] Referring to FIGS. 8A(i) to 8D, articulating catheter 100 may toggle between a relaxed or flexible configuration and at one or more biased (curved) configurations. In the relaxed configuration, tension is not applied to either deflection mechanism and the shaft is in its most flexible state, which may be advantageous for advancing through vasculature. In this state, it is possible for the shaft to curve at various regions, but it is not actively curved, that is, no tension is applied to either pull wire. In other words, at rest in the flexible configuration, shaft 106 is substantially straight, but deformable. Flexible configuration may also be referred to as “slack configuration”.

[0127] FIG. 8A(i) shows shaft 106 in a slack configuration and substantially straight and in line with a shaft longitudinal axis X. FIG. 8A(ii) shows shaft 106 slightly curved in relation to the X-axis, but the curve is not due to a tension in a pull wire, rather the curve is a result of the flexible properties of the shaft. In some embodiments, when shaft 106 is deformed, it will return to a substantially straight configuration upon release. In other configurations, shaft 106 retains a slight curve upon being released.

[0128] Referring to FIG. 8B, in a first biased configuration, tension is applied to the first deflection mechanism, and not the second deflection mechanism, such that only one anchor is actuated, and shaft 106 curves in the first deflection region 151. For example, the proximal anchor 132a is activated and shaft 106 adopts a proximal curve 150.

[0129] Referring to FIG 8C, in a second biased configuration, tension is applied to the second deflection mechanism, and not the first deflection mechanism, such that shaft curves in the second deflection region 153, different from the first deflection region 151. For example, distal anchor 132b is activated and shaft 106 adopts a distal curve 152.

[0130] In a third biased configuration, tension is applied to both deflection mechanisms, such that shaft 106 adopts two curves in two deflection regions 151, 153, forexample, proximal curve 150 and distal curve 152, as shown in FIG. 8D. Distal anchor 132b and proximal anchor 132a are both activated. This may also be referred to as a “double curve”, “S-curve”, or “S-shaped curved”.

[0131] One skilled in the art will appreciate that the number of degrees of curvature from the longitudinal X-axis may vary considerably at one or both anchor points. A curve may be considered as any actuated curve greater than zero degrees deviation from the longitudinal X-axis. In some examples, a curve may vary between 0 degrees and 180 degrees. In other examples, a curve may be greater than 180 degrees.

[0132] The deflection mechanisms described herein can be used to “aim” a distal end 102 towards a target blood vessel while a portion of shaft 106 is located within an initial vessel. “Aiming” means that the distal end 102 and distal opening point towards the target vessel. For example, the initial vessel may be the aortic arch 10 and the target vessel may be the brachiocephalic artery 12. The brachiocephalic artery 12 branches off from the aorta, or, in other words, is in fluid communication with the aorta. The S-curve of the articulating catheter 100 facilitates advancement of one or more devices through the articulating catheter 100, into the brachiocephalic artery 12, as shown in FIG. 9. Proximal curve 150 helps guide the device over the aortic arch 10 and distal curve 152 aims the distal end 102 towards brachiocephalic artery 12. This facilitates advancement of an inner device, for example, secondary catheter 200 or guidewire 300 further into the vasculature, such as into the right common carotid artery 14. While brachiocephalic artery 12 is one example, the articulating catheter 100 can be manipulated to take other shapes to facilitate advancement into any number of other vessels, for example the left common carotid artery or left subclavian artery.

[0133] The articulating catheter 100 can be used in accessing the target vessel by engaging the distal and proximal anchors while the device is within a blood vessel, such that the proximal and distal curves come into contact with and brace against the vessel walls, which provides stability, and limits (longitudinal) movement of the device while other devices, such as the secondary catheter 200 and guidewire 300, are advanced through.The ability of the articulating catheter 100 to maintain its position within neurovasculature facilitates the introduction of other devices, for example treatment devices for a neurovascular procedure. As would be obvious to one skilled in the art, articulating catheter 100 can be used in non-neurological applications, for example, any application where bracing the proximal curve against an anatomical structure could aid in positioning the distal end of the catheter into the target vessel. Some applications include peripheral interventional radiology and cardiology.Pull Wires and Pull Rings

[0134] Different shaped cross-sections of pull wires have different mechanical / bending properties. In one embodiment, pull wires 128a, 128b are ‘flat’ pull wires having a low profile. Flat pull wires may be used to favor deflection along a particular axis and resist deflection along another axis.

[0135] In another embodiment, pull wires 128 have a large cross section profile, such as a circular or round or elliptical cross-section. In some embodiments, distal pull wire 128b extends over or under proximal pull ring 130a, which may lead to problematic size constraints. To address this, in one embodiment, proximal pull ring 130a includes a cutout, slot, or other space for distal pull wire 128b to pass through as it extends from the shaft proximal end 116 to the distal pull ring 130b.

[0136] With reference to FIG. 10, in one embodiment, pull ring 130 is substantially “C-shaped” such that it defines a gap 139. Gap 139 may be used when the pull ring 130 is added to the shaft during assembly and also allows space for a pull wire 128 to pass through. For example, proximal pull ring 130a may define gap 139 for distal pull wire 128b. In one embodiment, both the proximal and distal pull rings 130a, 130b are C-shaped. In another embodiment, the proximal pull ring 130a is C-shaped, and the distal pull ring 130b is O-shaped, in other words does not have a gap.Secondary Catheter

[0137] With reference to FIG. 11 A, in one embodiment, secondary catheter 200 has a distal region 202 and a proximal region 204, where the distal region 202 includes a soft flexible portion, soft enough to not deflect the articulating catheter 100 when the secondary catheter 200 is received within lumen 110. In other words, the length of the soft, flexible region is such that it extends from the distal end to a region within at least the proximal curve 150. Distal region 202 is sized such that it does not significantly affect the curves or articulating catheter 100. In other words, it does not hinder the performance of articulating catheter 100 while it is received within the articulating catheter 100.

[0138] In one example embodiment, as shown in FIG. 11 A, secondary catheter 200 includes a distal region 202 that comprises a low-density polyethylene “LDPE” and proximal region 204 includes a 72D polyether block amid or similar material. In one example embodiment, distal region 202 is between about 100 mm to about 200 mm, for example. In some embodiments, secondary catheter 200 comprises a reinforcement layer, for example a metal braid, that extends throughout the proximal region 204, underneath the 72D Pebax.

[0139] In another embodiment, distal region 202 comprises a first distal portion 202a and a second distal portion 204b, as shown in FIG. 11B. The first distal portion 202a comprises LDPE and second distal portion comprises a 35D PEBA. In such an embodiment, a reinforcement layer extends into the second distal portion 204b within the shaft inner and outer walls. In one example embodiment, the first distal portion 202a is between about 10 mm to about 50 mm and second distal portion 202b is between about 100 mm to about 150 mm, for example.

[0140] In some embodiments, secondary catheter 200 comprises a pre-fixed curved distal end 206.

[0141] The devices and methods disclosed herein may be used in other areas of a patient’s body, including in renal artery selection, for example, the devices and methods can be used to access arteries that branch from the abdominal aorta, including left and rightrenal arteries, celiac trunk, superior mesenteric artery, and inferior mesenteric artery. Another application may be for lead placement in the heart where stabilizing a lead in a complex cardiac environment is difficult. Further applications include interventions involving the aortic valve and other cardiac applications. There are also a number of applications where bracing the proximal curve against an anatomical structure could aid in positioning the distal end of the catheter into the target vessel, including peripheral interventional radiology and cardiology.

[0142] The embodiment(s) of the invention described above are intended to be exemplary only. The scope of the invention is therefore intended to be limited solely by the scope of the appended claims.

[0143] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub combination.

[0144] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation, or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Claims

CLAIMS1. An articulating catheter comprising: an elongate member having a distal segment and a proximal segment, the elongate member comprising a plurality of layers including a reinforcement layer extending substantially from the distal segment to the proximal segment, the elongate member defining at least one interrupted region where the reinforcement layer is discontinuous; a first pull wire coupled to a first pull mechanism; and a second pull wire coupled to a second pull mechanism; wherein applying tension to the first pull wire causes the elongate member to adopt a first curve in a first portion of the elongate member, and applying tension to the second pull wire causes the elongate member to adopt a second curve in a second portion of the elongate member; and wherein at least one of the first and second pull mechanisms is located within the at least one interrupted region.

2. The articulating catheter of claim 1, wherein the first pull mechanism is located within the distal segment and the second pull mechanism is located within the at least one interrupted region.

3. The articulating catheter of claim 1, wherein the reinforcement layer comprises a braid.

4. The articulating catheter of claim 3, wherein the braid has a first configuration in the at least one interrupted region and a second configuration in the distal segment and the proximal segment.

5. The articulating catheter of claim 4, wherein the first configuration of the braid in the at least one interrupted region comprises a single braid pattern and the second configuration of the braid in the distal segment and proximal segment comprises a double braid pattern.

6. The articulating catheter of claim 1, wherein the reinforcement layer comprises a first reinforcement structure in the distal segment and a second reinforcement structure in the proximal segment.

7. The articulating catheter of claim 6 wherein the first and second reinforcement structures are each selected from the group consisting of a braid, a coil, and a hypotube.

8. The articulating catheter of claim 1, wherein the elongate member has a first interrupted region and a second interrupted region where the reinforcement layer is discontinuous, and wherein the first pull mechanism is located within the first interrupted region and the second pull mechanism is located within the second interrupted region.

9. The articulating catheter of claim 8, wherein the reinforcement layer comprises a braid.

10. The articulating catheter of claim 9, wherein the braid has a first configuration in each of the first interrupted region and the second interrupted region, and a second configuration in each of the distal segment and the proximal segment.

11. The articulating catheter of claim 10, wherein the first configuration of the braid in at least one of the first interrupted region and the second interrupted region comprises a single braid pattern and the second configuration of the braid in the distal segment and proximal segment comprises a double braid pattern.

12. The articulating catheter of claim 8, wherein the first interrupted region is distal to the second interrupted region, and wherein the reinforcement layer comprises a first reinforcement structure distal to the first interrupted region, a second reinforcement structure located between the first and second interrupted regions, and a third reinforcement structure proximal to the second interrupted region.

13. The articulating catheter of claim 12 wherein the first, second, and third reinforcement structures are each selected from the group consisting of a braid, a coil, and a hypotube.

14. The articulating catheter of claim 1 further comprising a plurality of stiffness zones.

15. The articulating catheter of claim 1, wherein at least one of the first and second pull mechanisms comprises a pull ring.

16. The articulating catheter of claim 1, wherein at least one of the first and second pull mechanisms comprises a hypotube.

17. The articulating catheter of claim 1 further comprising a control hub operatively coupled to the proximal segment of the elongate member.

18. The articulating catheter of claim 17 wherein the control hub comprises a first actuator for controlling tension in the first pull wire and a second actuator for controlling tension in the second pull wire.

19. The articulating catheter of claim 18, wherein the control hub comprises at least one locking mechanism for locking at least one of the first and second actuators.

20. The articulating catheter of claim 19, wherein the control hub comprises a first locking mechanism for locking the first actuator and a second locking mechanism for locking the second actuator.

21. An articulating catheter comprising: an elongate member defining a distal segment and a proximal segment, the elongate member comprising a plurality of layers including a reinforcement layer extending substantially from the distal segment to the proximal segment, the elongate member further defining at least one interrupted region where the reinforcement layer is discontinuous; and a deflection mechanism comprising a pull mechanism, the pull mechanism being located within the interrupted region; and wherein applying tension to the deflection mechanism causes the elongate member to adopt a curve in a portion of the elongate member.

22. A kit comprising: the articulating catheter of claim 1 ; and a secondary catheter, sized to be received within the articulating catheter of claim 1; wherein while the secondary catheter is received within the articulating catheter of claim 1, articulation of the articulating catheter is unimpeded.

23. An articulating catheter comprising: a shaft having a proximal segment, a distal segment, and an intermediate segment located between the proximal segment and the distal segment, the shaft comprising a reinforcement layer, the reinforcement layer comprising a plurality of reinforcement members; a first reinforcement member of the plurality of reinforcement members extending from the proximal segment to the distal segment;a second reinforcement member of the plurality of reinforcement members extending within the proximal segment and terminating therein; a third reinforcement member of the plurality of reinforcement members extending within the distal segment and terminating therein; and a pull ring coupled to a pull wire, the pull ring located within the intermediate segment.

24. The articulating catheter of claim 23, wherein the first and second reinforcement members cooperatively form a first pattern in the proximal segment, and wherein the first reinforcement member forms a second pattern in the intermediate segment; and wherein the first and third reinforcement members cooperatively form a third pattern in the distal segment25. The articulating catheter of claim 24, wherein the first and third patterns comprise the same pattern.

26. The articulating catheter of claim 25, wherein the first and third patterns comprise a braid pattern.

27. The articulating catheter of claim 26, wherein the second pattern comprises a coil pattern.

28. The articulating catheter of claim 23, wherein the plurality of reinforcement members comprises at least one flat wire and at least one round wire.

29. The articulating catheter of claim 28, wherein the first reinforcement member comprises a flat wire and the second and third reinforcement members comprise round wires.

30. An articulating catheter comprising: a shaft having a proximal segment, a distal segment, and an intermediate segment located between the proximal segment and the distal segment, the shaft comprising a reinforcement layer, the reinforcement layer comprising a plurality of reinforcement members; and a pull ring coupled to a pull wire, the pull ring located within the intermediate segment; wherein at least two reinforcement members of the plurality of reinforcement members cooperatively form a first pattern in the proximal segment, and whereinat least one reinforcement member forms a second pattern in the intermediate segment; and wherein at least two reinforcement members of the plurality of reinforcement members cooperatively form a third pattern in the distal segment31. The articulating catheter of claim 30, wherein the first and third patterns comprise the same pattern.

32. The articulating catheter of claim 31, wherein the first and third patterns comprise a braid pattern.

33. The articulating catheter of claim 32, wherein the second pattern comprises a coil pattern.

34. A method of assembling an articulating catheter shaft, the articulating catheter shaft comprising a shaft having a proximal segment, a distal segment, and an intermediate segment located between the proximal and distal segments, the method comprising the steps of: applying a first layer to a mandrel; overlaying a reinforcement layer onto the first layer, the reinforcement layer comprising a plurality of reinforcement members forming a first pattern; removing a portion of at least one reinforcement member, thereby creating the intermediate segment; and adding at least one pull ring within the intermediate segment; wherein the reinforcement layer in the intermediate segment comprises at least one reinforcement member forming a second pattern, the second pattern being different from the first pattern.

35. The method of claim 34, wherein the proximal segment and distal segments comprise a braid pattern and the intermediate segment comprises a coil pattern.

Images