Guidewire device with shaped tip and bypass incision

Abstract

The present disclosure relates to a guide wire device (900) having a shaped end and effective torsion resistance. The guide wire device includes a core (902) having a proximal section and a tapering distal section. A tubular structure (904) is coupled to the core so that the tapering distal section extends into the tubular structure. The tubular structure includes a plurality of bypass cuts (930, 940) formed tangentially within the tubular structure to increase the flexibility of the tubular structure and reduce the tendency of elastic forces from the tubular structure to damage the shaped distal end of the guide wire device.

Description

[0001] This application is a divisional application of Vascular Sciences Inc.'s invention patent application (filing date: March 6, 2019, application number: 201980030260.4, invention name: "Guidewire device with a formable end and bypass incision").

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. patent application Ser. No. 15 / 917,255, filed Mar. 9, 2018, entitled “GUIDWIRE DEVICESHAVING SHAPEABLE TIPS AND BYPASS CUTS,” the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0004] Guidewire devices are typically used to lead or guide a catheter or other interventional device to a target anatomical location in a patient's body. Typically, a guidewire is passed through the patient's vascular system to reach the target location, which may be, for example, at or near the patient's heart or neurovascular tissue. Radiographic imaging is typically utilized to help navigate the guidewire to the target location. In many cases, the guidewire is left in place in the body during an interventional procedure where it can be used to guide multiple catheters or other interventional devices to the target anatomical location.

[0005] Some guidewire devices are configured with curved or bent ends to allow the operator to better navigate the patient's vasculature. With such a guidewire, the operator can apply torque to the proximal end of the guidewire or an attached proximal handle to orient and point the end in a desired direction. The operator can then further guide the guidewire through the patient's vasculature in the desired direction.

[0006] Adjusting the flexibility of the guidewire device (particularly the distal section of the guidewire device) is also a problem. In many cases, a relatively high level of flexibility is required to provide sufficient bendability to the guidewire so that the guidewire can be angled through the winding bends and bends of the vascular system passage to reach the target area. For example, guiding the guidewire to the part of the neurovasculature (neurovasculature, neurovascular system) requires the guidewire to pass through a tortuous passage (such as the carotid siphon and other tortuous paths).

[0007] Another problem associated with guidewire devices is the ability of a given guidewire device to transmit torque from the proximal portion to the distal portion (i.e., the "torsionability" of the guidewire device). As the guidewire penetrates more and passes through a tortuous vascular system passage, the amount of frictional surface contact between the guidewire and the vascular system increases, thereby hindering the guidewire from easily moving through the vascular system passage. A guidewire with good torsionability enables the torque force at the proximal end to be transmitted through the guidewire to the distal end, thereby enabling the guidewire to rotate and overcome the frictional force.

[0008] Some guide wire devices include a micro-machined hypo tube (hypo tube) placed distally above the distal end of the guide wire core, so as to further distally guide the applied torsional force towards the end of the device. Because torsional force is transmitted mainly by the outer section of the cross section of the member, the pipe is configured to provide the path of the torque transmission increased compared with the torque amount transmitted by the guide wire core not wrapped by the pipe (sheath, covering). Typically, the pipe is formed by superelastic material (such as nitinol (nitinol, nickel titanium alloy)), so as to provide the torque transmission feature of expectation in addition to providing good flexibility level.

[0009] While the guidewire device has provided many benefits, several limitations exist. For example, many design features of the guidewire have a torque transmission tube that, while serving to provide increased torque transmission, hinders and limits the formability of the guidewire tip. Summary of the Invention

[0010] The present disclosure relates to a guide wire device with an energy forming end and effective torsion. In one embodiment, the guide wire device comprises a core, and the core has a proximal section and a tapered (tapered, tapered) distal section. A tubular structure is coupled to the core so that the tapered distal section extends into the tubular structure. The tubular structure includes a plurality of bypass incisions formed along a tangential direction within the tubular structure, to increase the flexibility of the tubular structure, and to reduce the trend of the forming distal end of the guide wire device destroyed by the elastic force from the tubular structure. The bypass incision is a part for an incision pattern, and the incision pattern forms a plurality of beams extending axially, and these beams connect a plurality of circumferential and transversely extending rings. The bypass incision forms a single beam incision pattern, and this single beam incision pattern forms a single beam between each adjacent ring in this single beam incision pattern.

[0011] Some embodiments further include a coil disposed within the tubular structure so as to be positioned between the outer surface of the distal section of the core and the inner surface of the tubular structure. The coil can be formed of a radiopaque material such as platinum. In some embodiments, the core is formed of stainless steel and the tubular structure is formed of a superelastic material such as nitinol.

[0012] In certain embodiments, at least a portion of incision pattern includes the single beam incision pattern of one side, and wherein a plurality of continuous beams are arranged on the single side of tubular structure relative to the longitudinal axis of guide wire device.In certain embodiments, incision pattern includes the double beam incision pattern arranged on the proximal side of single beam incision pattern.Double beam incision pattern can include the double beam incision pattern of the double beam incision pattern of depth symmetry and depth offset (depth-offset), wherein the double beam incision pattern of depth symmetry is arranged on the proximal side of the double beam incision pattern of depth offset, so that the double beam incision pattern of depth offset is used as the transition portion between single beam incision pattern and the double beam incision pattern of depth symmetry.

[0013] In some embodiments, the single beam cut pattern is arranged with cuts that increase in depth toward the distal end of the tubular structure and / or is arranged such that the spacing between consecutive cuts decreases toward the distal end of the tubular structure.

[0014] In some embodiments, the distal section of the core is formed of a formable material and is configured to have stiffness such that it can withstand deformation caused by the elastic restoring forces of the tubular structure when the distal tip is bent into the formed configuration.

[0015] In one embodiment, the tubular structure includes a first section and a second section, the second section being located distally of the first section. At the second section of the tube, the cut pattern forms a single beam between each pair of adjacent rings. The beams of the second section are arranged to form a preferred bending plane (e.g., by rotating each consecutive beam approximately 180 degrees relative to the previous beam). The tube presents minimal hindrance to bending within the preferred bending plane. In this embodiment, the distal section of the core passes through the second section of the tube and gradually tapers to a flat ribbon that coincides with at least a portion. The flat ribbon of the core has a main plane that is perpendicular to the preferred bending plane of the second section of the tube.

[0016] In another embodiment, a tubular structure includes a first section and a second section separated by a transition point, wherein the second section is located distal to the first section. The first section includes a double-beam cut pattern, and the second section includes a single-beam cut pattern. The double-beam cut pattern immediately proximal to the transition point and the single-beam cut pattern immediately distal to the transition point are configured such that the stiffness profile of the tubular remains substantially the same across the transition between the first and second sections. Furthermore, in this embodiment, the thickness of the proximal-most ring in the second section is greater than the thickness of the distal-most ring in the first section.

[0017] In another embodiment, the tube includes a first segment, a second segment distal to the first segment, and a third segment distal to the second segment. The first segment includes a dual-beam segment, the second segment includes a single-beam cut pattern, and the third segment includes a dual-beam cut pattern. The third segment extends proximally from approximately 0.25 mm to 2.5 mm when measured from the distal end of the tube.

[0018] Additional features and advantages will be set forth in part in the following description and in part will be obvious from the description, or may be learned by practice of the embodiments disclosed herein. The objects and advantages of the embodiments disclosed herein will be understood and attained by means of the elements and combinations particularly pointed out in the appended claims. It should be understood that both the foregoing brief summary and the following detailed description are exemplary and explanatory only and are not limiting of the embodiments disclosed herein or as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The invention, briefly described above, will now be described in more detail with reference to specific embodiments illustrated in the accompanying drawings. Understanding that these drawings depict only typical embodiments of the invention and are not intended to limit the scope of the invention, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0020] Figure 1 An exemplary embodiment of a guidewire device that provides effective torquability and has a shapeable tip is shown;

[0021] Figure 2 yes Figure 1 A cross-sectional view of a guidewire device;

[0022] Figure 3 Show that it can be used with Figure 1 and Figure 2 An exemplary embodiment of a tube structure for use with a guidewire device of the present invention, the tube having a bypass cut pattern (i.e., a single beam cut pattern) configured to provide effective flexibility and formability of the distal tip;

[0023] Figure 4 shows an alternative embodiment of a tube structure including segments having an alternative single beam cutout pattern;

[0024] Figure 5 An embodiment of a tube structure is shown that includes a dual beam cutout pattern having symmetrically spaced opposing beams;

[0025] Figure 6 An embodiment of a tube structure is shown that includes a segment having a single-sided single beam cutout pattern;

[0026] Figure 7An embodiment of a tube structure is shown that includes a bypass cut pattern having an exemplary angular offset to provide a resulting helical pattern of beams;

[0027] Figure 8 A perspective view showing an embodiment of a tube structure comprising three sections;

[0028] Figure 9A shows a side view of an embodiment of a tube including a distal section of a core disposed therein;

[0029] Figure 9B Show Figure 9A A cross-sectional view of a tube;

[0030] Figure 10 Show Figure 9A and Figure 9B an enlarged side view of a transition between a first section and a second section of the tube; and

[0031] Figure 11 Show Figure 9A and Figure 9B An enlarged side view of the distal end of the tube (including the second and third sections of the tube). DETAILED DESCRIPTION

[0032] The present disclosure relates to a guide wire device, which provides effective anatomical navigation capabilities. The ability of guide wire to be turned and directed to the target anatomical position depends on the trade-off between the ability to balance and optimize torsion and maintain the shaped end. The guide wire device can include a shaped end to allow the operator to point the end to the desired direction in the vascular system by rotating the distal end. However, if the torsion of this guide wire device is not enough, the operator will not be able to transfer torsional force to the shaped distal end to control the orientation of the shaped distal end. Along with the guide wire device further entering the vascular system and experiencing increasing frictional resistance, this obstruction will become more and more problematic. In addition, if the guide wire device can not correctly form and maintain the shaped end, the ability of its end orientation adjustment is limited, making intravascular navigation more difficult.

[0033] The embodiments described herein provide one or more features that balance and / or optimize the relationship between guidewire torquability and the ability to form and maintain a shaped distal tip that responds to operator manipulation during guidewire deployment and provides effective navigation capabilities by enabling the shaped distal tip to receive transmitted torsional forces.

[0034] In some embodiments, the shaped end allows the operator to customize the end shape, such as by manually shaping the end before the guide wire device is deployed in the patient's vascular system. Therefore, the operator can customize the shaping of the distal end according to preferences and / or the specific conditions of a given application. The guide wire device is also configured to effectively transmit torque while maintaining the shaped end. At least some embodiments described herein include such an end that can maintain a bend or curved shape throughout the entire surgical procedure or in multiple surgical procedures or even indefinitely until subjected to opposing reshaping forces.

[0035] Figure 1 The exemplary guide wire device 100 with core 102 is shown. Tube 104 is coupled to core 102 and extends distally from the attachment point 103 with core 102. As shown, the distal section of core 102 extends into tube 104 and is surrounded by tube 104. In certain embodiments, core 102 comprises one or more tapering sections so that core 102 can be assembled in tube 104 and extend into the tube. For example, the distal section of core 102 can be ground so as to taper to a smaller diameter at the distal end. In this example, core 102 and tube 104 have substantially similar external diameters at the attachment point 103 where they abut and attach to each other. In certain embodiments, core 102 and tube 104 have different external diameters at the attachment point 103 where they abut and attach to each other, and the difference in diameter is compensated by welding (weld, fusion), soldering (solder, solder), adhesive, interference fit (interference fit, interference fit) or other structural attachment means.

[0036] The tube 104 is coupled to the core 102 (e.g., using an adhesive, soldering, and / or welding) in a manner that allows torsional forces to be transferred from the core 102 to the tube 104 and thereby further distally through the tube 104. A medical grade adhesive 120 can be used to couple the tube 104 to the core wire 102 at the distal end of the device and form an atraumatic covering. As explained in more detail below, the tube 104 is microfabricated to include a plurality of incisions. The incisions are arranged to form a pattern of incisions that advantageously provides effective formability near the distal end of the guidewire device 100 while also maintaining good torsional properties. For clarity, the incisions are not shown in FIG. Figure 1 and Figure 2 The cutout pattern is not shown in FIG. Figures 3 to 5 Examples of cut patterns that may be used in tube 104 are shown in FIG.

[0037] The proximal section 110 of guidewire device 100 extends proximally to provide enough guidewire lengths to be delivered to the necessary length of target anatomical region.Proximal section 110 has a length in the scope of approximately 50cm to 350cm conventionally.Proximal section 110 can have a diameter of approximately 0.014 inch, or a diameter in the scope of approximately 0.008 inch to 0.125 inch.The distal section 112 of core 102 can taper to a diameter of approximately 0.002 inch, or a diameter in the scope of approximately 0.001 inch to 0.050 inch.In certain embodiments, the length of pipe 104 is in the scope of approximately 3cm to 100cm.

[0038] In some embodiments, the distal section 112 of the core 102 tapers to a circular cross-section. In other embodiments, the distal section 112 of the core 102 has a flat or rectangular cross-section. The distal section 112 may also have another cross-sectional shape, such as another polygonal shape, an oval shape, an erratic shape, or a combination of different cross-sectional shapes at different regions along its length.

[0039] Typically, the user will shape the distal end of the guidewire device 100 by manually bending, twisting, or otherwise manipulating the distal (approximately) 1 cm to 3 cm of the guidewire device 100 into the desired shape. Figure 1 This length is schematically shown as distal "tip" 106. In some embodiments, tip 106 comprises one or more formable components (within tube 104) formed of stainless steel, platinum, and / or other formable materials. In a preferred embodiment, tip 106 comprises one or more components formed of a material that exhibits work hardening characteristics such that the tip, after forming (i.e., plastic deformation), provides a higher elastic modulus at the formed section than before forming.

[0040] Figure 2 Show Figure 1sectional view of the guidewire device 100. As shown, the core 102 includes a proximal section 110 and a distal section 112, wherein the diameter of the distal section is less than the diameter of the proximal section 110. A coil 114 is located on at least a portion of the distal section 112 of the core 102. The coil 114 is preferably formed of one or more radiopaque materials (such as platinum group elements, gold, silver, platinum, titanium, osmium, tantalum, tungsten, bismuth, dysprosium, gadolinium, etc.). Additionally or alternatively, the coil 114 can be at least partially formed of stainless steel or other materials that can effectively maintain shape after being bent or otherwise processed by the user. In the illustrated embodiment, the coil 114 is arranged at or near the distal end of the device and extends a certain distance proximally toward the attachment point 103. In some embodiments, the length of the coil 114 is substantially consistent with the length of the tube 104. In other embodiments, the coil 114 is shorter. For example, coil 114 may extend 1 cm, 2 cm, 4 cm, 6 cm, 8 cm, 10 cm, 12 cm, 15 cm, 20 cm, 25 cm, 30 cm, or 35 cm from the distal end, or may extend from the proximal end a distance within a range defined by any two of the aforementioned values.

[0041] In some embodiments, the coil 114 is formed as a single piece. In other embodiments, the coil 114 comprises a plurality of separate segments positioned adjacent to one another and / or interlocked by intertwining coils. Additionally or alternatively, the separate segments may be welded, adhered, or otherwise secured to one another to form the complete coil 114. Some embodiments may comprise two or more coils, wherein at least one coil is configured to provide radiopacity and at least one coil is sized and shaped to improve centering of the distal segment 112 of the core 102 within the tube 104.

[0042] Although the illustrated embodiment shows a space between the coil 114 and the tube 104, it should be understood that this is schematically illustrated for ease of visualization. In some embodiments, the coil 114 is sized to fill and pack a greater proportion of the space between the distal section 112 and the tube 104. For example, the coil 114 may be sized to rest against both the distal section 112 of the core 102 and the inner surface of the tube 104. Other embodiments include a space between the core 102 and the tube 104 for at least a portion of a section of the guidewire device 100 (where the tube 104 and the core 102 extend together).

[0043] The coil 114 can advantageously be used to fill the space between the core 102 and the tube 104 so that the curvature of the distal section 112 of the core 102 aligns with the curvature of the tube 104. For example, when a curvature is formed in the tube 104, the tightly packed section of the coil 114 acts as a filler between the tube 104 and the distal section 112 to impart the same curvature to the distal section 112. In contrast, a guidewire device that omits the coil will not follow the same curve as the tube when bent at the tube, but will extend until it abuts the inner surface of the tube and then be forced to bend.

[0044] Embodiment described herein advantageously allows distal end 106 to be shaped to desired posture (position) and to keep a sufficiently long period of time in the shaped posture.Compared with traditional guide wire device, shown embodiment can form and maintain shaped structure.For traditional guide wire device, due to the characteristic mismatch between tube structure and the internal component (core and coil) and the problem relevant with formability often can occur.Tube structure is formed by nitinol or other superelastic materials conventionally.This pipe will be biased towards its original (straight line) posture when bending or shaping, and therefore will apply restoring force on any internal component that can be shaped, cause deformation and the loss of the customized shape of terminal.

[0045] In one embodiment, the guide wire 104 is a tube that is shaped and has a plurality of shaped ends. The tube ... Generally, for example, traditional guide wire will have a shaped end before deployment, but the shaped end will be lost or degraded during the use of the guide wire because the superelastic tube can be bent towards its initial shape opposite to the desired end shape. Therefore, the restoring force applied by the tube acts on (acts against, resistively acts on) the inner components, thereby reducing or degenerating the desired shape set by the user. By contrast, embodiments described herein include such features: end 106 is shaped when not subject to the leading (overriding) restoring force from tube. As described below, tube 104 can include a notch pattern that maintains effective torsion while also providing enough flexibility at distal end 106 to avoid destroying the customized shape of end 106.

[0046] Figures 3 to 7 An exemplary embodiment of a tube cut pattern that can be used in one or more guidewire device embodiments described herein is shown. Figures 3 to 7 One or more of the structures shown in Figure 1 and Figure 2 The tube 104 of the embodiment shown in FIG.

[0047] Figure 3A tube 504 is shown having a series of cuts 508 that form beams 530 (extending axially) and rings 540 (extending transversely and circumferentially). In the illustrated embodiment, the cuts 508 are arranged in the tube as a series of "bypass cuts." As used herein, a bypass cut is one that has no opposing cut directly opposite it relative to the longitudinal axis of the tube, thereby leaving a single beam 530 of longitudinally extending material between the rings 540 of transversely and circumferentially extending material. This "bypass" cut pattern may also be referred to herein as a "single beam" cut pattern. The transverse cross-sectional geometry of the beam can be a variety of shapes, including semicircular (such as those produced by a dicing saw with a circular blade), flat-sided (such as those produced by a laser machining operation), or any other type of cross-sectional shape. In the illustrated embodiment, the cuts are arranged as alternating cuts offset approximately 180 degrees from one cut to the next along the length of the tube 504, but can also be rotationally offset at angles other than 180 degrees to 0 degrees, as described below.

[0048] The pipe that forms using one or more sections of bypass (that is, single beam) otch as shown in the figure can provide many benefits, particularly provides many benefits about the relevant energy shaped end of guide wire device.For example, the flexibility of the pipe with bypass otch is relatively greater than not having otch or having and leaves the flexibility (for example, assuming that beam width, ring size and otch interval are equal in other respects) of the pipe of a plurality of beams between continuous rings.Beneficially, the flexibility of the increase provided by the bypass otch arrangement reduces to greatest extent or prevents that pipe makes the shape deformation of the internal structure of guide wire.For example, the core (for example stainless steel) that is arranged in pipe can be bent or curved (that is, plastic deformation), so that the shape of expectation is provided for the end of guide wire.

[0049] As described above, in many instances, the forces associated with the elastic recovery of the tube will be exerted on the forming core and will tend to straighten the forming core (at least with respect to the portion of the forming core disposed within the tube). Therefore, appropriately adjusting the flexibility of the tube will reduce the restoring forces exerted on the forming core and enable the forming core to better maintain its shape.

[0050] In some embodiments, the depth of a successive bypass cut or group of bypass cuts increases gradually for each successive cut or group of cuts moving toward the distal end. Thus, the cut depth profile can be used to construct a tube with desired flexibility and torsional properties for a given application. For example, a tube construction may include a proximal section with relatively lower flexibility and relatively higher torsional properties that rapidly progresses to a distal section with relatively higher flexibility and relatively lower torsional properties as the bypass cuts rapidly become deeper toward the distal end. In some embodiments, the section with the relatively deeper cuts is formed only at the most distal section of the tube where formability is expected or desired (e.g., the distal 1 cm to 3 cm of the tube) so as to retain higher torsional properties for the remainder of the tube.

[0051] Bypass incision 508 can change according to degree of depth, width and / or interval.For example, as incision 508 approaches the distal end of device, incision can gradually become deeper and / or more closely spaced. Deeper and / or more closely spaced incisions provide relatively greater flexibility. Therefore, a gradient can be formed, which provides the guidewire flexibility of increase in the gradually more distal region of guidewire. As described in more detail below, bypass incision 508 can also be arranged with alternate angular positions according to the angular offset applied at each adjacent incision or applied at the adjacent incision group. Illustrated embodiment shows the angular offset of 180 degrees from one incision to the next incision. Some embodiments can comprise the angular offset of about 5 degree, 15 degree, 30 degree, 45 degree, 60 degree, 75 degree, 80 degree or 85 degree from one incision to the next incision or from one group of incisions to the next group of incisions.

[0052] Figure 4 Another embodiment of a tube 604 is shown having a bypass cutout and a set of opposing, deeply offset, dual-beam cutouts disposed proximal to the bypass cutout. In the illustrated embodiment, the set of bypass cutouts creates beams 630. Proximal to beams 630 is a set of cutouts arranged as opposing cutouts that create beams 634. Although not visible in this view, an additional beam is formed opposite each beam 634 (obscured behind beams 634 in this view). Thus, each ring 640 within the deeply offset dual-beam cutout pattern has a set of two beams connecting it to its proximal neighbor and a set of two beams connecting it to its distal neighbor.

[0053] As shown, the opposing dual beam cuts are offset in depth so that for each opposing pair of cuts (one cut on each side of the pipe axis), the depth of one cut is greater than the depth of the opposing cut. This depth-offset dual beam cut can be advantageously used to remove a bypass cut (such as Figure 3 ) transitions to a non-offset, opposing double beam cut (such as Figure 5 ).

[0054] Figure 5 A section of tube 204 is shown having a dual beam cut pattern, with each cut in each opposing pair of cuts having approximately the same cut depth so that the resulting beams are substantially equally spaced circumferentially. As shown, the cuts result in a pair of beams 234 being formed between each ring 240. The cuts are shown here as being angularly offset by approximately 90 degrees from one pair of opposing cuts to the next, although other angular offsets may also be used.

[0055] A pipe section having a dual-beam cutout pattern with beams spaced substantially equidistantly along the circumference generally has a relatively higher torque-transmitting capability and relatively lower flexibility, while a pipe section having a bypass cutout generally has a relatively lower torque-transmitting capability and relatively higher flexibility. The torque transferability and flexibility of a pipe section having a dual-beam cutout configuration with offset depths generally lie between those of a section having opposed dual-beam cutouts with symmetrical depths and those of a section having bypass cutouts. The greater the difference in depth between the opposed cutouts, the closer the resulting beams will be circumferentially, and thus the more the offset dual-beam cutout will resemble a single-beam / bypass cutout. Similarly, the more similar the depths of the opposed cutouts, the more the offset dual-beam cutout will resemble a symmetrical dual-beam cutout.

[0056] Embodiments of the tube including offset dual-beam sections advantageously provide a transition zone that can be positioned and configured to provide desired transition characteristics between the distal bypass cutout region and the proximal symmetrical dual-beam section. For example, the transition zone can be relatively gradual or abrupt, depending on the length of the transition zone and / or on the rapidity of the change in offset in successive cutouts. Thus, the tube can be configured to provide a proximal section with greater torsion resistance and less flexibility that transitions into a more flexible distal section with greater flexibility to better maintain the bent shape when formed by the operator. The position and configuration of the proximal section, transition section, and distal section can be adjustable to optimize the benefits of effective torsion resistance and formable tip performance.

[0057] Figure 6 Another embodiment of a tube 704 is shown having a single beam cutout that forms a plurality of beams 730 and rings 740. As shown, the cutouts are arranged so that the beams 730 are aligned along one side of the tube 704, rather than being positioned alternately at 180 degrees or some other angular amount. Such an embodiment can advantageously provide preferential bending in one direction (e.g., toward the aligned beams 730), further minimizing the associated restoring forces away from the axis of the tube.

[0058] Figure 7An embodiment of a tube 304 is shown having a bypass cut pattern and angular offsets between the cut groups. As shown, the angular offsets position the resulting beams 330 in a rotating / helical circumferential pattern along the length of the tube segment. In some embodiments, a first angular offset is applied from one cut in a group to the next, and a second angular offset is applied from one cut to the next. For example, Figure 7 As shown in , each of the cutouts 308 in a pair of adjacent cutouts can be offset by about 180 degrees so as to leave the formed beams 330 on opposite sides of each other relative to the longitudinal axis of the guidewire, while each pair is offset from the adjacent pair by some other angular offset (e.g., about 5 degrees in the illustrated embodiment). In this way, the intra-set angular offsets can position the beams 330 on opposite sides of the guidewire axis, while the inter-set angular offsets can adjust the angular position of the continuous beam to be sufficient to minimize the preferred bending direction of the guidewire over a segment of several groups of cutouts 308.

[0059] Rotation offset can also be applied to Figures 3 to 6 In a preferred embodiment, each successive cut or group of cuts along the length of a given segment (e.g., every second cut, every third cut, every fourth cut, etc.) is rotationally offset by approximately 1, 2, 3, 5, or 10 degrees, or by approximately 1, 2, 3, 5, or 10 degrees from 90 degrees in a dual beam configuration, or by 1, 2, 3, 5, or 10 degrees from 180 degrees in a single beam configuration. These rotational offset values ​​have advantageously demonstrated good ability to eliminate flexure deviations.

[0060] For example, in a dual beam cut pattern where each pair of beams is equally spaced circumferentially, such as Figure 5 As shown, the rotational deviation of departing from about 1 degree, 2 degree, 3 degree, 5 degree or 10 degree from 90 degree is positioned to the misalignment (misalignment) with several degrees by every other pair of beams along the length of the notch section.For example, the second pair of beams can be rotationally offset slightly greater than or less than 90 degree relative to the first pair of beams, but the third pair of beams will only be rotationally offset a few degrees relative to the first pair of beams, and the fourth pair of beams will only be rotationally offset a few degrees relative to the second pair of beams.When arranging several continuous pairs of beams along the length of the notch section of the guide wire device in this way, the resulting structure allows the notch pattern to enhance flexibility and not introduce or increase the weight of (directional) flexibility deviation in any direction.

[0061] Figures 3 to 7 The individual components and features of the tube embodiments shown in FIG can be combined to form different tube configurations. For example, some tubes can be configured as sections with bypass (single beam) cutouts (e.g., Figure 3 、 Figure 6 and / or Figure 7) and sections of symmetrically spaced double beam cutouts (as shown in Figure 5 ), optionally also having one or more depth-offset dual beam cutouts (as Figure 4 For example, some tube embodiments may include a proximal section having a symmetrically spaced dual-beam cutout pattern that transitions to a distal section having a bypass cutout arrangement.

[0062] The embodiments described herein can advantageously enable the more proximal section of the tube to transmit relatively more torque, while reducing the torsional properties of the more distal section of the tube to allow for tip shaping without excessively sacrificing torsional properties. Thus, the characteristics of the guidewire device can be adjusted to a specific need or application to optimize the operational relationship between torsional properties, flexibility, and tip shaping properties.

[0063] In preferred embodiments, the formable distal section of the core has a stiffness capable of withstanding the expected bending forces acting on the distal section of the core from the tube after the distal section of the core is formed. In some embodiments, the formable distal section of the core is formed from a material or combination of materials that provides an elastic modulus that is about 1.5 to 4 times (or about 2 to 3 times) greater than the elastic modulus of the material(s) used to form the tube.

[0064] Figure 8 An embodiment of a tube 804 is shown having a first segment 850, a second segment 860, and a third segment 870. The second segment 860 is located distally of the first segment 850, and the third segment 870 is located distally of the second segment 860. Each of the segments 850, 860, 870 can be distinguished from one another by the cutout pattern of each segment. As discussed above with reference to other embodiments described herein, the cutout pattern can create loops 840 and beams 803 within the tube. Figure 8 The sections 850, 860, 870 shown in FIG can have different cut patterns in each section. For example, the first section 850 can have a double beam cut pattern, the second section 860 can have a single beam cut pattern, and the third section 870 can have a double beam cut pattern.

[0065] It is understood that other embodiments may include Figure 8. For example, in one embodiment, the first section 850 can have a cut pattern with more than two beams, the second section 860 can have a double beam cut pattern or a single beam cut pattern, and the third section 870 can have a single beam cut pattern or can be omitted. In addition, other embodiments of the tube 804 can include more or less than three sections along its length. For example, an embodiment of the tube 804 can include four or more sections. In addition, for example, an embodiment of the tube 804 can include only one or two sections. The cut patterns shown in any of the other embodiments described herein can be used. Additional cut patterns and other features that can be used are also described in co-pending U.S. patent application Ser. No. 15 / 698,553, which is incorporated herein by reference.

[0066] Figure 9A Shown with Figure 8 904 is a side view of an embodiment of a tube 904 that is similar to the embodiment of the tube shown in . Figure 9A The tube 904 also shows a partial cross-sectional view of the second section 960 to illustrate the core 902 extending through the distal section 912 of the tube 904 and the coil 914. Although only a partial cross-section is shown here, it will be understood that the core 902 will generally extend all the way to the distal end 922 of the device. In the illustrated embodiment, the second section 960 of the tube 904 includes a single beam cut pattern. The single beam cut pattern creates a series of axially extending beams 930, each of which is disposed between a pair of adjacent circumferentially extending rings 940.

[0067] In the embodiment shown, the positions of the consecutive beams 930 alternate from the first side 916 to the second side 918 of the tube 904 (i.e., each consecutive beam 930 has a rotational offset of approximately 180°). In another embodiment, the beams 903 of the single beam cutout pattern of the second section 960 can all be positioned along the same side of the tube to form a backbone of aligned beams 930 that extend axially along the tube 904 and connect the multiple rings 940, similar to Figure 6 The embodiment shown in .

[0068] like Figure 9A As shown, the single beam cut pattern of the second section 960 forms a preferred bending plane B. The preferred bending plane B extends axially along the tube 904 and transversely through the tube 904, as shown in FIG. Figure 9A Because the beams 930 of the second section 960 extend axially relative to the tube 904, the tube 904 is most flexible along the preferred bending plane B. That is, the beams 930 are configured so that the tube 904 is least resistant to bending along the preferred bending plane B than any other plane. In this exemplary embodiment, the cut pattern of the second section 960, whether producing Figure 9A The alternating pattern of beams 930 shown, or a single backbone of beams 930 as described above, both produce a preferred bending plane B.

[0069] In addition, if Figure 9A As shown, the distal section 912 of the core 902 tapers as it extends distally through the coil 914 and the tube 904 and tapers to a flat ribbon-like configuration at the distal portion. Figure 9B Shown by Figure 9A FIG1 is a transverse cross-sectional view of the tube 904 taken along plane AA. The distal section 912 of the core 902 is a substantially flat ribbon extending axially within at least the second section 960 of the tube 904. The ribbon-like configuration of the core 912 has a major dimension (D1) and a minor dimension (D2). The major dimension (D1) of the distal section 912 of the core 902 is greater than the minor dimension (D2) of the core 902, such that the major plane of the ribbon-like distal section 912 of the core 902 extends orthogonal to (and preferably perpendicular to) the preferred bending plane B. In this manner, the distal section 912 of the core 902, along with the tube 904, also offers minimal resistance to bending within the preferred bending plane B. In other words, the core 912 can be tapered into a ribbon-like configuration and extended axially along the tube 904 such that the distal section 912 of the core 902 is aligned with the beams 930 of the second section 960 such that it shares a preferred bending plane B with the tube 904 .

[0070] In one embodiment, the length of the second section 960 of the tube 904 is from about 0.5 cm to about 5 cm. In another embodiment, the length of the second section 960 of the tube 904 is from about 1 cm to about 2 cm. In yet another embodiment, the length of the second section 960 of the tube 904 is from about 1 cm to about 1.5 cm. The distance to which the second section 960 extends from the distal end 922 can vary depending on the length of the tube 904 that is bent or shaped for a given procedure. These distances can vary between embodiments as needed to accommodate various procedures. Figures 8 to 9B Other features of the embodiment shown in (including the materials and dimensions of coil 914, tube 904, and core 902, and including specific features related to the cut pattern) can be similar to other embodiments described herein with reference to other figures.

[0071] Figure 10A close-up view of the transition between a first section 950 and a second section 960 of a tube 904 is shown. In the illustrated embodiment, the first section 950 includes a dual-beam cutout pattern, while the second section 960 includes a single-beam cutout pattern. The stiffness of the tube 904 in each section depends, at least in part, on the amount of material remaining in the tube 904 after the cutouts have been formed and the amount of material remaining in the arrangement / spacing of the remaining beams 930. For example, all other things being equal, a section of the tube 904 having two beams 930 between each pair of adjacent rings 940 will have a greater stiffness than a section of the tube 904 having a single beam 930 of the same size between each pair of adjacent rings 940. Furthermore, for example, all other things being equal, a section of the tube 904 having a greater distance between the cutouts will have a greater stiffness than a section having a smaller distance between the cutouts. That is, the greater the distance between the cuts, the greater the thickness of the ring 940 formed between the cuts, and the greater the stiffness of the tube 904 in that section.

[0072] Set in Figure 10 The cutouts, rings 940, and beams 930 at or near the transition point between the first section 950 and the second section 960 of the tube 904 shown in FIG are configured so that the stiffness distribution of the tube 904 is approximately continuous across the transition between the two sections 950 and 960. In other words, the cutout patterns of the first section 950 and the second section 960 are arranged to avoid a significant jump in stiffness from one side of the transition point to the other.

[0073] Of course, depending on the specific granularity level at which the stiffness is measured along the tube 904 and on the specified length of the measured segment, there may be some level of discrete variation in stiffness between different measured segments. Because an infinite number of stiffness measurements cannot be made, the actual measurable stiffness distribution will consist of stiffness levels measured at each of a series of discrete segment lengths of the tube. While the jumps (i.e., changes in stiffness) from one measured segment to the next can be discrete, the overall pattern of such jumps preferably approximates a linear series or at least a smooth curve. Thus, in the context of the present disclosure, a "significant jump" occurs when the jump from one segment to the next is greater than any immediately adjacent jump by more than about 1.5 times. Thus, when there is no jump at a transition point that is greater than more than about 1.5 times any adjacent jump, significant jumps are avoided, and the stiffness distribution at the transition point is therefore "continuous." Preferably, there is no jump at a transition point that is greater than more than about 1.2 times any adjacent jump.

[0074] Figure 10An embodiment of a tube 904 having rings 940 and beams 930 that achieve a continuous stiffness distribution at the transition between sections 950, 960 is shown. In the illustrated embodiment, the axial thickness of the proximal ring 940a of the second section 960 is greater than the axial thickness of the distal ring 940b of the first section 95. In this way, the total amount of material of the tube 904 at the transition is similar between sections 950, 960 at or near the transition. As described above, this results in a continuous stiffness across the transition. In addition, the axial thickness of the ring 940 of the second section 960 can decrease distally along the length of the tube 904, resulting in a corresponding decrease in stiffness. This is in Figure 10 shown in Figure 9A Shown more dramatically.

[0075] Now go to Figure 11 , the distal end 906 of the tube 904 is shown. Figure 11 The distal tip 906 shown in FIG. 1 includes a third segment 970, at least a portion of the second segment 960, and a polymer adhesive 920 disposed distally of the third segment 970 at the distal end 922 of the tube 904. The third segment 970 of the tube 904 includes a dual-beam cutout pattern that forms two beams 930 between each pair of adjacent rings 940. This contrasts with the single-beam cutout pattern of the second segment 960. It will be appreciated that the transition between the second segment 960 and the third segment 970 can be similar to the transition between the first segment 950 and the second segment 960, as described above. That is, the stiffness of the tube 904 can be substantially continuous across the transition from the second segment 960 to the third segment 970.

[0076] An adhesive 920 disposed at the distal end 922 of the tube 904 may extend between the tube 904 and the core at the distal end 922 of the tube 904 to secure the tube 904 and the core together. Figure 1 As shown in FIG, the distal section 112 of the core 102 can extend distally beyond the tube 104 and into the adhesive 120. Thus, the adhesive 120 can be used to couple the tube 104 to the core and / or coil 114.

[0077] Reference again Figure 11Adhesive 920 can be disposed on distal end 922 of tube 904 and at least partially wicked proximally into one or more incisions between each ring 940 and beam 930 of third section 970. Compared to the single beam incision pattern of second section 960, the dual beam incision pattern of third section 970 provides an increased surface area of ​​tube 904 material to which adhesive 920 can bond. Thus, the dual beam incision pattern of third section 970 provides a stronger connection between adhesive 920 and the distal section of the core and / or coil. It will be appreciated that an incision pattern including more than two beams 930 between each pair of adjacent rings 940 can thus be used to enhance the strength of the connection between tube 904 and the distal section of core 102 and / or coil. However, as described above, the more material removed from tube 904 by the incisions, the less rigid tube 904 will be, and vice versa.

[0078] Furthermore, during manufacturing, providing a greater amount of adhesive 920 on the distal end 922 of the tube 904 will cause the adhesive 920 to wick further proximally up the tube 904. Due to the number and spacing of the cuts in the cut pattern, the double-beam cut pattern of the third section 970 provides the manufacturer with an effective visual indication of how far the adhesive 920 is wicking proximally along the third section 970. This visual indication of the third section 970 may also assist a machine or other automated manufacturing device in detecting how far the adhesive 120 is wicking proximally along the third section 970 during manufacturing.

[0079] For example, during manufacturing, when the manufacturer places adhesive 920 on the distal end 922 of the tube 904, the adhesive may begin to wick through the spaces between the rings 940 and the beams 930 in the third section 970. Because the double beam cut pattern of the third section 970 provides a visual indication, the manufacturer can more easily discern how far the adhesive has wicked proximally along the tube 904 from one ring 940 to the next compared to the single beam cut pattern of the second section 960. Thus, the manufacturer can determine how much adhesive 120 to place on the distal end 922 of the tube 904. The manufacturer can also determine when to stop adding adhesive 120 based on whether the adhesive 920 has wicked to a predetermined distance or to the rings 940.

[0080] In one embodiment, the third section 970 of the tube 904 extends distally between approximately 0.5 mm and 1.5 mm from the distal end 922 of the tube 904. In another embodiment, the third section 970 of the tube 904 extends distally between approximately 0.75 mm and 1.25 mm from the distal end 922 of the tube 904. In yet another embodiment, the third section 970 of the tube 904 extends distally approximately 1 mm from the distal end 922 of the tube 904. The distance to which the third section 970 extends from the distal end 922 can vary depending on the length of the tube 904 that needs to be bent or shaped, or the distance required for the adhesive 920 to adequately wick along the tube 904. These distances can vary between different embodiments to accommodate various tubes and procedures as needed. Figure 10 and Figure 11 Other features of the embodiment shown in , including the materials, properties, and dimensions of the coil 914 , tube 904 , and core 902 , can be similar to other embodiments described herein with reference to other figures.

[0081] As used herein, the terms "approximately," "about," and "substantially" refer to an amount or condition that is close to a stated amount or condition and still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," and "substantially" may refer to an amount or condition that deviates from a stated amount or condition by less than 10%, or less than 5%, or less than 1%, or less than 0.1%, or less than 0.01%.

[0082] Elements described with respect to any embodiment depicted and / or described herein may be combined with elements described with respect to any other embodiment depicted and / or described herein. Figures 3 to 7 Any of the elements described in any of the pipe sections can be combined and used to form Figure 1 and Figure 2 at least a portion of the tube of the guidewire device or Figures 8 to 11 In some embodiments, the core wire may be provided with a tube having at least a portion of a guidewire device. In addition, embodiments may include a tube having multiple bypass cutouts, dual beam cutouts with offset depths, and / or dual beam cutouts with symmetrical depths, as described herein. In any of the foregoing combinations, the distal end of the core wire may be rounded, flattened, or otherwise shaped.

[0083] The present invention may be implemented in other forms without departing from the spirit or essential characteristics of the present invention. The described embodiments are to be considered in all respects as illustrative only and not restrictive. Therefore, the scope of the present invention is indicated by the appended claims rather than the preceding description. All changes within the meaning and equivalent range of the claims are intended to be included within the scope of the claims.

Claims

1. A guidewire device having a formable tip, the guidewire device comprising: a core having a proximal section and a distal section; a tubular structure coupled to the core such that a distal section of the core passes into the tubular structure, the tubular structure having a first section, a second section distal to the first section, and a third section distal to the second section, wherein the tube structure comprises a cutout pattern forming a plurality of axially extending beams connecting a plurality of circumferentially extending rings, wherein the cutout pattern forms two or more beams between each pair of adjacent rings in the first section, a single beam between each pair of adjacent rings in the second section, and two or more beams between each pair of adjacent rings in the third section, wherein the beams of the first section are configured to avoid the formation of a preferred bending plane and the beams of the second section are configured to form the preferred bending plane, wherein at least a portion of the distal section of the core passes through the second section of the tube, the at least a portion being a flat strip having a major plane and a minor plane, and The inner surface of each beam of the second section faces the main plane of the flat strip and intersects the preferred bending plane.

2. The guide wire device according to claim 1, wherein The length of the second section is 0.5 cm to 5 cm.

3. The guide wire device according to claim 1, wherein: The positions of the beams between the rings in the second section alternate from a first side of the tube structure to a second side of the tube structure, the second side being approximately 180 degrees opposite the first side to form the preferred bending plane.

4. The guide wire device according to claim 1, wherein: The beams between the rings in the second section are aligned on a single side of the tube structure to form a backbone of aligned beams connecting the plurality of rings within the second section and forming the preferred bending plane. 5 . The guidewire device of claim 1 , further comprising a coil disposed within the tubular structure so as to be positioned between an outer surface of the distal section of the core and an inner surface of the tubular structure. The guide wire device according to claim 1 , wherein: The tube structure is formed of a superelastic material.

7. The guidewire device of claim 1 , further comprising an adhesive disposed at a distal end of the tubular structure, the adhesive coupling the tubular structure to the core, wherein The adhesive extends into the tube and is located between two or more rings in a third section of the tube structure.

8. A guidewire device having a shapeable tip, the guidewire device comprising: a core having a proximal section and a distal section; as well as a tubular structure coupled to the core such that the distal section of the core passes into the tubular structure, the tubular structure having a first section and a second section distal to the first section, wherein the tubular structure includes a plurality of cutouts extending transversely into the tubular structure, each cutout forming one or more beams defined by a remaining section of tubular material, each beam connecting two adjacent rings of tubular material, wherein the thickness of the most proximal ring of the second segment is greater than the thickness of the most distal ring of the first segment, and The stiffness of the tube structure is continuous at the transition between the first section and the second section.

9. The guide wire device according to claim 8, wherein: The second segment includes a midpoint, and wherein an average ring thickness of the second segment proximal to the midpoint is greater than an average ring thickness of the second segment distal to the midpoint.

10. The guide wire device according to claim 8, wherein: The plurality of cutouts of the second section are arranged with the cutouts decreasing in spacing toward the distal end of the tubular structure.

11. The guidewire device of claim 8, further comprising a coil disposed within the tubular structure so as to be positioned between an outer surface of the distal section of the core and an inner surface of the tubular structure.

12. The guide wire device according to claim 8, wherein: The tube structure is formed of a superelastic material.

13. The guide wire device according to claim 8, wherein: The first section has a cutout pattern of two or more beams between adjacent rings, and the second section has a cutout pattern forming a single beam between each pair of adjacent rings.

14. The guide wire device according to claim 13, wherein: The length of the second section is 0.5 cm to 5 cm.

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