US20040111044A1 - Medical device for navigation through anatomy and method of making same - Google Patents

Abstract

Medical devices for navigation through anatomy, including guidewires, which may have a core wire, a slotted tubular member, or both. Embodiments may have coils, including non-circular cross-section edge-wound marker coils, extended coil tips, and soldered or glued mesial joint coils. Core wires may have a step, ridge, or taper at the joints to the tubular member, and may be flattened at the distal tip. Radiopaque material may be located inside the tubular member, and the distal tip may be heat treated to make it shapeable. Additional tubular members or coils may be used concentrically or in line and may enh in depth radunequal in depth opacity, reduce friction, or reduce material or manufacturing cod in groups, such as groups of three, and may be equally spaced around the axis or offset to provide a steerable or compressible tip.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application claims priority to U.S. Provisional Application Serial No. 60/399,046, filed Jul. 25, 2002, entitled “Guidewire Inventions and Construction Methods.”[0001]
FIELD OF INVENTION
• This invention relates generally to medical devices for navigating through anatomy and methods of making them.[0002]
BACKGROUND OF THE INVENTION
• Medical devices, such as endovascular or intravascular devices, have been used for many years for purposes such as performing various medical procedures. A medical device such as an intravascular device may be introduced into a patient's anatomy or vasculature at a relatively accessible location, and guided through the patient's anatomy to the desired location. X-ray fluoroscopy has been used to observe the tip of the medical device and the device has been rotated at bifurcations in the anatomy or vasculature before being pushed further to guide the device to the desired target location. Medical devices of this type may be solid, for example, a guidewire, or may be hollow and tubular, for example, a catheter. Guidewires may be used to guide one or more tubular intravascular devices to a particular location, and catheters may be used, for instance, to deliver fluids, extract fluids, or deliver various objects, agents, or devices to the particular location.[0003]
• In many applications it is desirable that a medical device or intravascular device bend easily in order to allow it to make the various bends and turns that are necessary to navigate through the anatomy or vasculature, and in some cases also to minimize trauma to the anatomy or vasculature. However, in many applications it is also desirable that the medical device is stiff enough to not prolapse, for example, when navigating through relatively large vasculature. It may also be desirable that such medical devices be relatively stiff in torsion in order to allow precise control of rotation in order to guide the device through bifurcations in vasculature or around obstacles. Another desirable feature of many embodiments is that they minimize friction with the anatomy to facilitate their insertion, removal, or both. It may also be desirable for these medical devices to have adequate radiopacity, particularly at the distal end, to make them observable under X-ray fluoroscopy for purposes of navigation.[0004]
• In addition, it is desirable that medical devices, such as guidewires, are strong and durable enough to assure their complete removal from the patient. Thus, it is desirable that such devices have adequate tensile strength and resist fatigue during use. Further, where expensive materials such as nitinol are used, or expensive fabrication techniques such as forming many slots, it is desirable that the quantity of these materials or techniques be limited to locations where they are actually needed in order to make the devices as inexpensive to manufacture as possible. Other features and benefits are also desirable, at least some of which are described herein or are apparent from this document.[0005]
SUMMARY OF INVENTION
• The present invention provides medical devices including intravascular devices such as guidewires. Features of various embodiments of the present invention include that the devices provide the desired flexibility in bending, provide excellent stiffness in torsion, reduce friction with the anatomy, provide better radiopacity than the prior art, particularly at the distal end, resist fatigue, minimize trauma to the patient's anatomy, are capable of navigating through tortuous vasculature, provide the necessary tensile strength to assure complete removal of the medical device, and are inexpensive to manufacture. Other features and benefits are described herein or are apparent from this document, including features and benefits for particular embodiments of the present invention.[0006]
• Accordingly, the present invention provides a medical device for navigation through anatomy having an elongate body with a proximal end, a distal end, and a longitudinal axis extending at least from the proximal end to the distal end. Such a medical device may include a helical coil formed from wire having a substantially non-circular cross section, and the cross section may have a greater dimension in the radial direction than in the axial direction. The body may include a tubular member with a plurality of slots, which may be configured to make the body or tubular member more flexible in bending. The coil may be located at or near the distal end of the tubular member, and may be made of a substantially radiopaque material. The body may further have a core wire, and at least part of the core wire may be located inside the tubular member, inside the coil, or both. Such a medical device may be a guidewire, for example.[0007]
• The present invention also provides a medical device configured to be guided to a target location in anatomy, having a tubular member and a core wire extending proximally from the tubular member and attached there with a joint. This joint may have a coil circumscribing the core wire, and at least partially inside the tubular member, and may utilize solder, adhesive, or both. For instance, the core wire and the coil may be metal, and the joint may have solder attaching the coil to the core wire and adhesive attaching the coil, solder, core wire, or a combination thereof, to the tubular member. To allow room for solder, adhesive, or both between the windings, at least a portion of the coil may have a pitch of at least 1.5 times the diameter of the coil wire.[0008]
• In some embodiments, the core wire may have a tapered portion, and the joint may be located at least partially within the tapered portion. And in some embodiments, the core wire may have a feature configured to facilitate mechanical interlock of the solder or adhesive, and the joint may be located at that feature. Such a feature may include, for example, a step, a ridge, or both. Thus, in some embodiments of the present invention, the core wire may have at least one abrupt change in cross-sectional dimension, for example, between its proximal and distal sections. The core wire may be attached to the tubular member with the proximal end of the tubular member abutting the abrupt change in cross-sectional dimension or abutting a proximal coil attached to the core wire. There may be a smaller diameter mesial coil circumscribing at least a portion of the core wire, which may be soldered to the core wire, and the tubular member may be attached to the mesial coil, for example, with adhesive. And in various embodiments, the core wire may further be attached to the tubular member at the distal end of the tubular member, at one or more locations intermediate the proximal end and the distal end, or both.[0009]
• In some embodiments of the present invention, the core wire may generally have a substantially round cross section, but a distal section of the core wire located inside the tubular member may have a flattened cross section for at least a portion of its length. Such an embodiment may have substantially radiopaque material located inside the tubular member at the distal section or end, which may have a substantially semicircular cross section and may be located on opposite sides of the flattened cross section of the core wire.[0010]
• In some embodiments of the present invention, there may be a coil extending distally from the distal end of the tubular member. Such a coil may be made of a substantially radiopaque material, and there may be a mesial coil of another material proximal to the radiopaque coil. The core wire may extend distal to the tubular member inside the coil, and may attach at the distal end of the coil, core wire, or both. In such embodiments, the core wire may be axially but not torsionally constrained relative to the coil at the distal tip of the core wire.[0011]
• In other embodiments of the present invention, the tubular member may extend distal to the distal tip of the core wire and the medical device may have at least one piece of radiopaque material inside the tubular member, at or adjacent to the distal end of the tubular member, and distal to the distal tip of the core wire. In such embodiments, the core wire may be attached to the tubular member at the distal tip of the core wire. The radiopaque material may be in the shape of a helical coil, for example. In some embodiments, the tubular member may have superelastic properties, and at least part of the distal end may be heat treated to reduce its superelastic properties, for example, to make it shapeable by the user. And in some embodiments, the tubular member may have a chamfer at its proximal end.[0012]
• The present invention still further provides embodiments having a tapered body, at least in its outside diameter over at least a portion of its length. The taper may have a decreasing outside diameter in the distal direction, and may be either continuous or incremental. In some embodiments, the core wire may have a larger outside diameter along at least a majority of its proximal section than that of the tubular member. But in some embodiments, the tapered portion may include the tubular member. In an incrementally tapered embodiment of the tubular member, the tubular member may have an outside diameter that changes in at least one step between the proximal end and the distal end. In some such embodiments, the tubular member may have a plurality of sections which may have different outside diameters, and the sections may be attached to each other to form the tubular member.[0013]
• Various embodiments of the tubular member include a plurality of groups of slots formed therein, which may be substantially perpendicular to the axis, and these groups may include a plurality of slots at substantially the same location along the axis. At least a plurality of the longitudinally adjacent groups of slots may be rotated at an angle around the axis from the previous group, and the angle may be in the range of 180 degrees plus or minus no more than 40 degrees, that quantity divided by the number of slots in the group. In some embodiments, at least a plurality of the groups may have at least three slots or may consist of precisely three slots. In such embodiments, the angle of rotation between adjacent groups may be 180 degrees divided by the number of slots in the group, plus or minus no more than 10 degrees.[0014]
• In some embodiments, each slot in at least a plurality of the groups may be substantially equal in size and equally spaced around the axis. But in some embodiments, in at least some groups, at least one slot may be substantially deeper than at least one other slot. In such embodiments, the medical device may be configured so that tensioning the core wire causes the distal end of the tubular member to change in shape, such as bending or changing the angle of bend. In addition, in some embodiments, the spacing between adjacent groups of slots may vary gradually or incrementally along at least part of the tubular member providing a varying bending stiffness along that distance, and these groups may be more closely spaced at the distal end.[0015]
• Further, some embodiments of the present invention may have another tubular member. Thus, some embodiments of the present invention may have two tubular members which may share a common longitudinal axis, and may be attached to each other, to the core wire, or both. One or both tubular members maycircumscribe at least a portion of the core wire, and the two tubular members may be concentric or in line with each other. One or both tubular members may have a plurality of slots configured to make it more flexible in bending, but one or both tubular members may also have a portion without slots, which may be proximal to the portion with slots. In some embodiments, one tubular member may lack slots altogether, and may be made of a polymer material. In some embodiments, one tubular member may be made of a substantially radiopaque material. There may also be at least one coil concentric with at least one of the tubular members, the core wire, or a combination thereof. One coil may be inside at least one of the tubular members, and some embodiments may have at least one coil circumscribing the core wire. At least one tubular member may be at least partially located inside a coil. Such coils may be used in joints, provide additional bending stiffness, or provide a greater or smoother outside diameter, for example.[0016]
BRIEF DESCRIPTION OF DRAWINGS
• The figures in this document illustrate various exemplary embodiments of the present invention. Embodiments of the present invention may include part or all of the features shown in one of these drawings, or may include features from two or more figures. Embodiments of the present invention may also include features described in the specification, or limitations to features described in the specification. Furthermore, embodiments of the present invention may include features that would be familiar to a person of ordinary skill in the art having studied this document.[0017]
• FIG. 1 is a partially cross-sectional side view illustrating an embodiment of a medical device in accordance with the present invention inserted in vasculature in anatomy;[0018]
• FIG. 1A is a detail cross-sectional side view of part of the embodiment illustrated in FIG. 1;[0019]
• FIG. 2 is a partially cross-sectional side view illustrating a mid-portion and distal end of an embodiment of a medical device in accordance with the present invention having a coil inside a slotted tubular member;[0020]
• FIG. 3 is a partially cross-sectional side view illustrating a mid-portion and distal end of an embodiment of a medical device in accordance with the present invention having an extended coil tip;[0021]
• FIG. 4 is a side view illustrating a partially wound coil made from wire having a non-circular cross section;[0022]
• FIG. 5 is a cross-sectional side view illustrating the distal end of an embodiment of a medical device in accordance with the present invention having an extended coil tip and a core wire configured to be free to rotate within the tip of the device;[0023]
• FIG. 6 is a cross-sectional side view illustrating the distal end of an embodiment of a medical device in accordance with the present invention having an extended coil tip and an internal coil;[0024]
• FIG. 7 is a cross-sectional side view illustrating the distal end of an embodiment of a medical device in accordance with the present invention having two tubular members arranged in line;[0025]
• FIG. 8 is a cross-sectional side view illustrating the distal end of an embodiment of a medical device in accordance with the present invention having a core wire that terminates proximal to the distal end of the device, and substantially radiopaque material inside the distal end of a tubular member;[0026]
• FIG. 9 is a cross-sectional side view illustrating the distal end of an embodiment of a medical device in accordance with the present invention having a core wire with a distal section comprised of a plurality of strands of material twisted together;[0027]
• FIG. 10 is a cross-sectional side view illustrating the distal end of an embodiment of a medical device in accordance with the present invention having a core wire with a flattened distal end;[0028]
• FIG. 11 is a partially cross-sectional side view illustrating an embodiment of a mesial joint in accordance with the present invention having a coil around a core wire and inside a tubular member;[0029]
• FIG. 12 is a partially cross-sectional side view illustrating an embodiment of a mesial joint in accordance with the present invention having at least two coils around a core wire at least one located at least partially inside a tubular member;[0030]
• FIG. 13 is a partially cross-sectional side view illustrating an embodiment of a mesial joint in accordance with the present invention having two coils and a core wire with a ridge forming an abrupt change in diameter;[0031]
• FIG. 14 is a side view illustrating an embodiment of a mesial joint in accordance with the present invention a coil partially located within a helical cutout in a tubular member;[0032]
• FIG. 15 is a partially cross-sectional side view illustrating an embodiment of a mesial joint in accordance with the present invention having two coils, one inside a tubular member, and the other abutting the tubular member;[0033]
• FIG. 16 is an isometric view of a section of one embodiment of a tubular member in accordance with the present invention having slots formed therein in groups of three, wherein the slots are equal in size and equally spaced around the axis of the tubular member;[0034]
• FIGS. 16A through 16D are cross-sectional end views showing cross sections of the slots and segments there between of the embodiment of the tubular member illustrated in FIG. 16;[0035]
• FIG. 17 is an isometric view of a section of one embodiment of a tubular member in accordance with the present invention having equal size slots formed therein in groups of two, wherein adjacent groups are rotated 85 degrees lots are equally spaced around the axis of the tubular member;[0036]
• FIGS. 17A through 17D are cross-sectional end views showing cross sections of the slots and segments there between of the embodiment of the tubular member illustrated in FIG. 17 showing the angle of rotation between adjacent groups of slots and segments;[0037]
• FIG. 18 is an isometric view of a section of one embodiment of a tubular member in accordance with the present invention having slots formed therein insome groups of two, wcontain slots of unequal depthing groups of slots are unequally spaced around the axis of the tubular member;[0038]
• FIGS. 18A through 18D are cross-sectional end views showing cross sections of the slots and segments there between of the embodiment of the tubular member illustrated in FIG. 18;[0039]
• FIG. 19 is an isometric view of a section of one embodiment of a tubular member in accordance with the present invecontain slots of unequal depths formed therein in groups of two, wherein all of the groups of slots are unequally spaced around the axis of the tubular member;[0040]
• FIGS. 19A through 19D are cross-sectional end views showing cross sections of the slots and segments there between of the embodiment of the tubular member illustrated in FIG. 19;[0041]
• FIG. 20 is a partially cross-sectional side view illustrating an embodiment of a steerable medical device in accordance with the present invention having a tubular member with slots formed and arranged like the embodiment shown in FIG. 18;[0042]
• FIG. 20A is a partially cross-sectional side view illustrating the tip of the embodiment of a steerable medical device shown in FIG. 20 adjusted into a bend;[0043]
• FIG. 21 is a cross-sectional side view illustrating the distal end of an embodiment of a medical device in accordance with the present invention having three tubular members arranged coaxially;[0044]
• FIG. 22 is a cross-sectional side view illustrating the distal end of an embodiment of a medical device in accordance with the present invention having two tubular members and a coil on the outside;[0045]
• FIG. 23 is a cross-sectional side view illustrating the distal end of an embodiment of a medical device in accordance with the present invention having two tubular members arranged in line; and[0046]
• FIG. 24 is a cross-sectional side view illustrating the distal end of an embodiment of a medical device in accordance with the present invention a tapered portion of a tubular member in line with a slotted portion of a tubular member.[0047]
DETAILED DESCRIPTION
• The present invention provides medical devices and intravascular devices such as guidewires and catheters, improvements to such devices, and methods of making these devices. Included in the present invention are various embodiments providing substantially radiopaque material at or near the distal end to facilitate X-ray fluoroscopy including edge-wound coils, and substantially radiopaque material located inside a tubular member, which may be slotted to improve its bending flexibility. The present invention also includes various embodiments of flexible distal tips including extended coil tips, and tips with a flattened core wire. The present invention even further includes various embodiments of a mesial joint between a core wire and tubular member. Many such embodiments use a coil between the core wire and proximal end of the tubular member, and solder, adhesive, or both. The present invention still further includes various embodiments of medical devices with a coil or second tubular member sharing a common longitudinal axis with the first tubular member, which may reduce the necessary length of the first tubular member, provide radiopacity, reduce friction, seal the slots, provide better bending flexibility, or a combination of these benefits. The present invention also includes embodiments of various geometry of slots formed in a tubular member, inclarrangements of s. ps of two, three, or more, and geometries wherein different slots in at least some groups are unequally spaced around the axis, unequal in depth, or both. These later embodiments provide a steerable device. The present invention also provides embodiments having tapered bodies, which may include tapered tubular members.[0048]
• Accordingly, FIG. 1 illustrates an exemplary embodiment of the present invention,[0049]guidewire100. Use as a guidewire is one example of a use or function of a medical device in accordance with the present invention. Various elements of the present invention may be used for other purposes including various medical purposes.Guidewire100 may includetubular member130 andcore wire150, which may be attached to each other, for example, at joint140.Tubular member130,core wire150, or both, may form an elongate body ofguidewire100, which may have a common axis through its length from at least the proximal end to the distal end. In other words,tubular member130 andcore wire150 may share a common longitudinal axis. As used herein, components are said to share a longitudinal axis if they are coaxial or in line. The body ofguidewire100 may have aproximal end154 and adistal end138 ortip137. This body may include anelongate section159 proximal to joint140 and an elongate section distal to joint140. The distal elongate section may includetubular member130distal section158 ofcore wire150, or both, for example.Tubular member130 may havedistal end138 andproximal end139.Distal end138 may includedistal tip137 ofguidewire100, which may be rounded as shown.Joint140 is atproximal end139 oftubular member130, in the exemplary embodiment illustrated.
• [0050]Core wire150 may extend proximally from tubular member130 (e.g., fromproximal end139 or joint140 as shown).Core wire150 may also extend distally from joint140 insidetubular member130 as shown.Core wire150 may have a circular cross section, and may have aproximal section159, which may have a constant outside diameter along part or all of its length, and adistal section158, which may have a smaller diameter thanproximal section159. In some embodiments,proximal section159 may have a substantially constant diameter along a majority of its length. In some embodiments,proximal section159,distal section158, portions thereof, or a combination of these, may be tapered with a decreasing diameter towarddistal tip137.Distal section158 ofcore wire150 may be located at least partially insidetubular member130 as shown. In various embodiments,tubular member130 may have an outside diameter that is smaller, larger, or the same size asproximal section159 ofcore wire150. The outside diameter oftubular member130 may be substantially constant along all or a majority of its length, or may be tapered, exemplary embodiments of which are described below. Similarly, the inside diameter oftubular member130, and the wall thickness, may be substantially constant along the length oftubular member130, or may be tapered.
• [0051]Guidewire100 may be configured to be flexible in bending, particularly neardistal end138. The bending stiffness ofguidewire100 may gradually or incrementally decrease alongguidewire100 towarddistal tip137, or along a portion ofguidewire100. For example, the bending stiffness may be constant alongproximal section159 ofcore wire150, but may decrease gradually alongdistal section158 ortubular member130, for instance, fromproximal end139 todistal end138. This flexibility may be accomplished, at least in part, with a plurality ofslots135 formed in at least part oftubular member130 as shown in several figures including FIG. 1.Slots135 may be micromachined intotubular member130, and may be configured to maketubular member130 more flexible in bending. To provide a change in bending stiffness along the length oftubular member130,slots135 may be closer together, deeper, or wider, neardistal end138, in comparison withproximal end139. In some embodiments,proximal end139 oftubular member130 may have noslots135, as shown in FIG. 1. In other embodiments,proximal end139 may containslots135, but they may be farther apart than atproximal end138, for example. This spacing may vary gradually alongtubular member130, or may change incrementally. In many embodiments,slots135 may actually be closer together than what is shown in FIG. 1.
• In some embodiments, the stiffness of all or part of core wire[0052]150 (for example, distal section158) may also change along its length by reducing in dimension or diameter. In some embodiments, varying flexibility alongguidewire100 may be accomplished or aided by using materials with different properties at different locations. In some embodiments, more flexible materials may be used at the distal end, while stiffer materials may be used at the proximal end. In some embodiments, more flexible materials may be used at the outside surface farther from the longitudinal axis, while stiffer materials may be used in the center or near the axis. Different components made of two or more different materials having different elasticity may be joined with joints. For example,tubular member130 may be made of a superelastic material such as nitinol, to allow it to bend more without yielding or fatiguing. In comparison,core wire150 may be made of a stiffer material having a greater modulus of elasticity, for example, stainless steel. As used herein, materials that have two percent recoverable strain, or more, are considered to be superelastic materials and have superelastic properties. Nitinol, for example, may have a recoverable strain of up to ten percent, depending on the chemistry, heat treatment, and the like. Nitinol having a recoverable strain of at least two percent is considered herein to be superelastic.
• In embodiments wherein[0053]tubular member130 is made of a superelastic material andcore wire150 is made of a stiffer or more common material such as stainless steel, there may be various advantages to using more of one component than the other, or relying on one component rather than the other to provide various properties such as bending stiffness. For instance, a stainlesssteel core wire150 may have a lower material cost than superelasticnitinol tubular member130. In addition, it may be expensive to formslots135 intubular member130. Thus, there may be a cost benefit to minimizing the length oftubular member130. In addition,slots135 may substantially reduce the tensile strength oftubular member130. Therefore, it may be an advantage forcore wire150 to be as large as possible to provide adequate tensile strength when the medical device is removed. On the other hand, due to its superelastic properties,tubular member130 may be able to bend or twist more without failing or deforming plastically. In addition, due to its shape or cross section, slottedtubular member130 may provide a greater torsional stiffness relative to its bending stiffness, thancore wire150, thus providing greater rotational control ofdistal tip137 fromchuck152. Thus, there may also be advantages to having a relatively longtubular member130, or usingtubular member130 to provide bending stiffness rather thandistal section158 ofcore wire150.
• As an example, some embodiments of the present invention may have a[0054]proximal end139 oftubular member130 without slots135 (illustrated, for example, in FIGS. 1, 20, and24), whereas other embodiments of the present invention may have a shortertubular member130 omitting aproximal end139 without slots135 (illustrated, for example in FIG. 3), and providing the desired bending stiffness in this area with a larger diameter ofcore wire150. The first such type of embodiments may be more expensive to make (assumingtubular member130 is longer), but may be able to bend more sharply at unslottedproximal end139 oftubular member130 without undergoing plastic deformation or experiencing fatigue. The first such type of embodiments may also be stiffer in torsion at that location. In this example, the first type of embodiments may provide adequate tensile strength at unslottedproximal end139, since there are no slots reducing the tensile strength ofproximal end139. Further, it may be beneficial to attachtubular member130 tocore wire150 at the distal end of the unslotted portion. Both such types of embodiments are described in more detail below.
• [0055]Guidewire100 is shown in FIG. 1 navigating throughanatomy101. Specifically, guidewire100 is shown penetrating through anopening102 that has been cut into the surface ofskin103 and intovasculature105.Guidewire100 is shown passing a distance throughvasculature105, including through twobifurcations107 and108.Distal end138 may includebend133, which may facilitate navigatingguidewire100, for example, through the desired branch ofbifurcations107 and108.Core wire150 may contain a handle or chuck152, which may be attached or clamped toproximal end154 orproximal section159 ofcore wire150, and may be manipulated to rotateguidewire100 about its axis. For instance, guidewire100 may be manually rotated as it is advanced throughvasculature105 to select the desired passageways, for example, atbifurcations107 and108.
• Accordingly, it is generally desirable that embodiments of the present invention move easily through[0056]anatomy101. Various features and components are described herein which may facilitate such movement, for example, by reducing friction betweenguidewire100 andanatomy101. For instance, all or part of various embodiments of the presentinvention including guidewire100 may be coated on its exterior surface with a lubricious coating or lubricant. As examples, guidewire100 may be coated with a PTFE, Parylene, hydrophilic, or hydrophobic coating.
• In some embodiments of the present invention, the tip or[0057]distal end138 is constructed with a particularpreformed bend133. In embodiments having adistal end138 made of a superelastic material, it may be difficult or impossible for a user to changebend133. One reason for this may be that the superelastic material oftubular member130,core wire150, or both cannot be bent sharply enough to take a permanent set. Accordingly, embodiments of the present invention include a method for making a medical device orguidewire100 that includes locally reducing the superelastic properties in the tip ordistal end138 of the medical device orguidewire100, enough that the tip ordistal end138 can be shaped by bending it around a tight radius.
• This may be done, for example, by first forming the medical device, at least part from a superelastic material such as nitinol, and then heat treating or annealing the part of the tip or[0058]distal end138 that is desired to be shapeable. An example of such a cycle consists of heating the tip ordistal end138 to approximately 600 degrees C. for 10 seconds. The result may be a reduction in the superelastic effect in the heat treated zone which may provide the ability to achieve a permanent set orbend133 in the material ofdistal end138 when it is bent sharply.
• A user of such a medical device or[0059]guidewire100 with a shapeable tip, such a doctor or surgeon, may determine the optimal angle and location ofbend133, for example, from the type of procedure to be performed, the anatomy of the particular patient (e.g., the geometry of bifurcations107 and108), or both. The user may then bendtip133, and proceed to insertguidewire100 into opening102 ofanatomy101 and intovasculature105, and to observedistal end138 ofguidewire100 with x-ray fluoroscopy, for example, while navigatingguidewire100 throughvasculature105. In some embodiments, magnetic resonance imaging (MRI) may be used for observation instead or in addition. Atbifurcations107 and108, the user may rotatechuck152 to turnbend133 to pointdistal tip137 toward the desired direction and advance guidewire100 to the target location. Once at the target location, the user may perform a medical procedure or advance a catheter overguidewire100 to that location to perform a procedure. When the procedure is completed, or when the catheter is installed, the user may pull guidewire100 out throughopening102.
• The present invention includes techniques for construction and embodiments of[0060]small diameter guidewires100. Various embodiments of the present invention may be advantageous, for example, in medical devices having small diameters (for example, outside diameter (OD) of the guidewire <0.014″). In such embodiments, the outer diameter ofproximal section159 ofcore wire150 proximal totubular member130 may be larger than the outer diameter oftubular member130. This may giveproximal section159 ofcore wire150 more torsional stiffness, but this may be at the expense of greater bending stiffness. In many applications, the greater bending stiffness may not be a problem forsmall diameter guidewires100 because the tortuosity of the anatomy (e.g., of vasculature105) that theproximal section159 ofcore wire150 must traverse may be low enough to permit greater bending stiffness.
• In some embodiments of the present invention, including small-[0061]diameter guidewires100, it may be beneficial to have a relatively-stiff (in bending) portion ofguidewire100 proximal todistal end138. Relatively-high stiffness in this area may prevent prolapsing whenguidewire100 is being advanced in relatively-large vessels105, and may facilitate catheter tracking where a sharp branch is negotiated off a relatively-large vessel105. This relatively-stiff portion may be created, for example, by spacingslots135 further apart in this relatively-stiff portion oftubular member130. As an example, guidewire100 may be constructed with a bending stiffness of approximately 0.00005 pound inches squared (lb-in{circumflex over ( )}2) for the first one half centimeter (cm) of length fromdistal tip137, followed by a gradual increase in stiffness to 0.0002 lb-in{circumflex over ( )}2 one cm fromdistal tip137. The stiffness may then remain constant until about four cm fromdistal tip137, at which location the stiffness may decrease gradually to about 0.0001 lb-in{circumflex over ( )}2 five cm fromdistal tip137. The stiffness may then remain constant until about eight cm fromdistal tip137, at which location the stiffness may increase graduallyto about 0.0004 lb-in{circumflex over ( )}2 approximately twenty cm fromdistal tip137. The bending stiffness may then remain substantially constant (e.g., alongproximal section159 of guidewire100).
• In a variety of embodiments, medical devices in accordance with the present invention, including[0062]guidewire100, may have a dense material indistal end138 ortip137, for example, to make the end or tip more easily observable under x-ray fluoroscopy. An exemplary embodiment of aguidewire100 with a substantiallyradiopaque coil200 is illustrated in FIG. 2. This embodiment ofguidewire100 utilizes a micromachined or slotted nitinol torque tube ortubular member130 surroundingsection158 ofcore wire150.Marker coil200 may lie insidetubular member130 at or neardistal end138, and may circumscribe or surrounddistal end257 ofcore wire150. The helical coil shape ofcoil200 may allowdistal end138 to remain flexible in bending, whiletubular member130 may maintain relative torsional stiffness ofguidewire100 to tip137.Coil200 may be made of a dense material such as, for example, a platinum-tungsten or platinum-iridium alloy to achieve adequate radiopacity fordistal end138. Such metals are “substantially radiopaque”, as that phrase is used herein. In general, materials having substantially more radiopacity than stainless steel or nitinol are considered herein to be substantially radiopaque. Some embodiments of the present invention may have acoil200 that is not made of a substantially radiopaque material. such ahelical coil200 may, for example, contribute to the bending stiffness of the device,center core wire150, facilitate bonding between other components, or a combination of these functions.
• One problem to be overcome in small diameter guidewires is providing adequate radiopacity. In order to increase the[0063]radiopacity coil200 to a required or desired level, the diameter of the platinum or tungsten wire may be increased. But because the annular space betweencore wire150 and the inner diameter of the micromachinedtubular member130 may be small, there may not be enough space to provide an adequatelyradiopaque coil200 betweencore wire150 andtubular member130. In addition, increasing the diameter of the wire used towind marker coil200 may have the undesired effect of increasing the bending stiffness ofmarker coil200. Several approaches in accordance with the present invention may be used to overcome this problem.
• In an exemplary embodiment illustrated in FIG. 3,[0064]helical coil200 is larger in diameter thancoil200 shown in FIG. 2, and extends beyonddistal end138 oftubular member130 rather than being located insidetubular member130. Thus, FIG. 3 illustrates an exemplary embodiment of the present invention having anextended coil tip300.Section158 ofcore wire150 may provide the desired stiffness in bending and torsion, and may provide tensile strength.Coil200 may contribute to the stiffness ofextended coil tip300, especially in bending. In some embodiments,coil200 may provide all of the bending stiffness ofextended coil tip300. Some such embodiments may lackcore wire150, at least within part of or all ofextended coil tip300.
• [0065]Helical coil200 may be attached todistal end138 oftubular member130, and may extend distally therefrom, for example, todistal tip137.Extended coil tip300 may provide radiopacity, an atraumatic diameter to contact the anatomy that is significantly larger in diameter thancore wire150, or both. Anextended coil tip300 havinghelical marker coil200 illustrated in FIG. 3, may be used, for example, in a 0.014-inch OD coronary guidewire. The length ofextended coil tip300 orcoil200 may range, for example, from 0.5 to 5 cm.
• In some embodiments of the present invention,[0066]coil200 may be wound from wire having a round or circular cross section. But other embodiments, wire with a non-circular or substantially non-circular cross section may be used. In some embodiments, such a non-circular cross section may have at least one flat side, or two, three, or four flat sides, for example. As illustrated in FIGS.2-5,coil200 may be formed from an edge wound strip, which may give coil200 a high degree of bending flexibility, greater radiopacity, or both. Thus, the cross section of the wire from whichcoil200 is made, may have a greater dimension in the radial direction than in the axial direction (i.e., relative to the longitudinal axis), trapezoidal, Edge woundcoil200 may also provide improved torsional stiffness, strength, or both, when compared with other embodiments.
• The edge-wound flat or rectangular cross-section illustrated for[0067]coil200 allows the construction of acoil200 with a higher radiopacity (density), a lower bending stiffness, or both, in comparison with acoil200 wound from round wire. This is because when a strip is wound on edge to form coil200 (i.e., has a greater dimension in the radial direction than in the axial direction) it may result in a lower stiffness, and a greater density (and hence radiopacity), or both, when compared to a coil with the same inside diameter (ID) and outside diameter (OD) wound from round wire. Specifically, arectangular strip coil200 may have, for example, about {fraction (1/7)}^thof the lateral stiffness and ⅓ more density, when compared with around wire coil200. The increase in density generally stems from better utilization of space. The stiffness may be decreased because there are more turns of a less stiff wire in a given length of therectangular wire coil200 than in the same length onround wire coil200. For instance,coil200 may have a 0.003-inch ID and a 0.009-inch OD. When made of a round wire, with a diameter of 0.003 inches,coil200 may have a 0.005-inch pitch, a lateral stiffness of 20μ (in{circumflex over ( )}2-lbs), and a density of 9 g/in. In comparison, acoil200 with a rectangular cross section may have a thickness (in the axial direction) of 0.0016 inches, a width (in the radial direction) of 0.003 inches, a 0.0027-inch pitch, a lateral stiffness of 3μ(in{circumflex over ( )}2-lbs), and a density of 12 g/in. This embodiment may be implemented, for example, in coronary or neuro guidewires.
• Referring now to FIG. 4,[0068]coil200 may be wound fromwire420. Thecross section440 ofwire420 may distort or change intocross section405 whenwire420 is would intocoil200. In order to obtain aparticular cross section405 of thewire forming coil200, the effect of this distortion may be taken into consideration in selecting thecross section440 ofwire420. In one embodiment of the present invention,wire420 may have a circular cross section before being wound, and may have a slightly distorted circular cross section after being wound. As used herein, such a slightly distorted circular cross section is considered to be substantially circular. But in other embodiments,coil200 may be made so that, when wound, it has a substantiallynon-circular cross section405, which may have at least one substantially flat side, for example, side406. In some embodiments,cross section405 may also have another substantially flat side407, which may be substantially parallel to side406. In some embodiments,cross section405 may also have substantiallyflat sides408,409, which may be parallel to each other, and may be shorter than sides406 and407. Some embod or trapezoidiments may have some combination of substantiallyflat sides406,407,408, and409.Cross section405 may be substantially in the shape of a parallelogram. In the exemplary embodiment illustrated,cross section405 is substantially in the shape of a rectangle. In embodiments ofcoil200 where sides406 and407 are large relative tosides408 and409 (edge-wound coils or coils having a greater dimension in the radial direction than in the axial direction), the distortion fromcross section440 tocross section405 will be greatest, but the flexibility ofcoil200 will also be greatest, relative to the radial distance [(OD402)/(ID401)]/2 available.
• [0069]Coil200 may be wound fromwire420, In some embodiments,sides446 and447 may be substantitally parallel, and when wound intocoil200, sides406 and407 may be out of parallel, withside408 longer thanside409. In come embodiments,cross section440 may have the shape of a rectangle, andcross section405 may have the shape of a trapezoid. In another embodiment, shich may have a substantiallynon-circular cross section440.Cross section440 may have two substantially flat oppositenon-parallel sides446 and447.Sides446 and447 may be out of parallel byangle444.Cross section440 may also have substantiallyflat sides448 and449, which may be shorter thansides446 and447, and may form a trapezoid which may be an isosceles trapezoid. In an isoscelestrapezoid cross section440,sides446 and447 are of equal length, andsides448 and449 are parallel. In some embodiments,side448,449, or both, may be curved, and may be convex. Similarly, in some embodiments,side408,409, or both, may be curved, and may be convex. In some embodiments, the effect of this curvature may be small or insignificant. But in some embodiments wherecoil200 forms the outer surface of the device (e.g., in the embodiments shown in FIGS. 3 and 5), convex curvature ofside409, or a rounding or chamfering of its corners, for example, may improve the lubricity of the medical device againstanatomy101, particularly in locations where extendeddistal tip300 is bent around a curve.
• In some embodiments,[0070]angle444 and the radius of coil200 (half of ID401, half ofOD402, or half of a nominal diameter between401 and402) may be selected such thatsides446 and447 become substantially parallel whenwire420 is wound intocoil200, andsides446 and447 become sides406 and407 respectively. Thus the amount of keystone shape orangle444 that may be needed or desirable may depend on the diameter (e.g., ID401 or OD402) of thecoil200 to be wound. The smaller thecoil200 diameter, the more keystone shape orangle444 may be needed to compensate for the deformation in thewire420 as it bends intocoil200. Other variables may affect theangle444, including the thickness (in the axial direction) of cross section405 (e.g., the length ofside408 or409). The shape ofcross section440 may be determined by calculation, empirically, or a combination thereof, to obtain a desiredcross section405.Cross section440 may be formed, for example, by drawing, rolling, grinding, ormachining wire420, or a combination thereof. Once the wire is formed withcross section440, the wire may be wound intocoil200 withcross section405. In various embodiments of the present invention,coil200 may be wound onto a medical device such asguidewire100, or may be installed onto the medical device in a separate step.
• FIG. 2 also illustrates an exemplary embodiment of the present invention having a[0071]proximal chamfer231 inproximal end139 oftubular member130.Proximal chamfer231 may be flat (e.g., a conic section) or curved (e.g., a radiused corner).Proximal chamfer231 may be beneficial, for example, in embodiments whereincore wire150 is gradually tapered at joint140, or whereinproximal section159 ofcore wire150 has a smaller OD than that ofproximal end139 oftubular member130. For example,chamfer231 may help provide a smooth transition in diameter from that ofproximal section159 ofcore wire150 toproximal end139 oftubular member130. This may facilitate removal ofguidewire100, reduce trauma to anatomy during removal, or both.Proximal chamfer231 may also facilitate a more gradual change in bending stiffness, reduce stress concentration, provide more surface area for bonding, or a combination of these benefits.Proximal chamfer231 may be implemented, for example, in neuro guidewires.
• FIG. 2 also illustrates an exemplary embodiment of the present invention having a relatively[0072]soft material261 between at least part ofdistal section158 ofcore wire150 andtubular member130. In addition, or in the alternative,material261 may fill or partially fill at least some ofslots135.Material261 may comprise urethane, an epoxy, an adhesive, or a polymer, for example.Material261 may increase the stiffness ofguidewire100. Thus,more slots135 may be required to obtain a desired bending stiffness. The greater number ofslots135, with less angle of bending perslot135, may result in a greater fatigue life oftubular member130. Increasing stiffness withmaterial261 rather than by using a larger diameterdistal section158 ofcore wire150 may help to avoid plastic deformation or fatigue ofsection158 ofcore wire150 for a given radius of bending, for example in particularlytortuous vasculature105. In addition, in embodiments wherematerial261 fills at least some ofslots135,material261 may provide a more constant outside diameter reducing friction between at lest that portion ofguidewire100 andanatomy101.
• FIGS. 2 and 3 also illustrate that[0073]section158 ofcore wire150 may extend distally from joint140 todistal tip257 atdistal end138 oftubular member130 or todistal tip137.Distal tip257 ofsection158 ofcore wire150 may attach totubular member130. In some embodiments, this may be accomplished by attachingdistal end138 oftubular member130 anddistal tip257 ofcore wire150 both todistal tip137. As used herein,core wire150 is said to be attached totubular member130 ifcore wire150 is attached directly to tubular member130 (e.g., with solder or adhesive) or ifcore wire150 is attached (e.g., with solder or adhesive347) to a coil (e.g.,1141 or200), busing (e.g.,757) ortip137, for example, andtubular member130 is also attached (e.g., with solder or adhesive347) to this same coil, bushing, or tip130 at substantially the same location along the longitudinal axis of the device.
• In embodiments having an[0074]extended coil tip300, the distal end ofcoil200 and thedistal tip257 ofcore wire150 may be attached to each other directly or viatip137. An exemplary embodiment is illustrated in FIG. 3. In some embodiments,distal end138 oftubular member130 may be attached tocore wire150, for example, through a coil, solder, adhesive, or a combination thereof. An exemplary embodiment where incore wire150 is attached todistal end138 of tubular member130 (viacoil200 and solder or adhesive337) is illustrated in FIG. 6. In the embodiment illustrated,distal tip257 ofcore wire150 is also attached todistal tip137 and the distal end ofextended coil tip300. Butextended coil tip300 may not be very stiff in torsion. Thus, iftip137 is rotated relative totubular member130, for example, anddistal section158 ofcore wire150 is completely attached atdistal end138 oftubular member130, and atdistal tip137, thensection158 ofcore wire150 may be damaged by exceeding its yield stress or recoverable strain in torsion.
• To solve this potential problem, the connection of[0075]core wire150 todistal end138 oftubular member130, tocoil200, or to tip137 may be configured in some embodiments to protectcore wire150 inside theextended coil tip300 from exposure to excessive toque. For instance, in some embodiments,core wire150 may not be bonded todistal end138 oftubular member130, or tocoil200 at that location. An example of such an embodiments is illustrated in FIG. 3. Abushing338 may be used atdistal end138 oftubular member130 to isolatesection158 ofcore wire150 from the adhesive orsolder347 used to attachdistal end138 oftubular member130 tocoil200 ofextended coil tip300. Bushing338 may also provide more bending strength, tensile strength, torsional strength, or a combination thereof in the joint, and may centerguidewire150. Bushing338 may be, for example, a section of tube or coil.
• In another exemplary embodiment illustrated in FIG. 5,[0076]distal tip257 ofcore wire150 may be axially but not torsionally constrained atdistal tip137 ofextended coil tip300. In the embodiment illustrated,bushing538 is attached to the distal end ofextended coil tip300 or todistal tip137 ofguidewire100.Distal section158 passes throughbushing538 and itsdistal tip257 is attached tobushing557.Bushings538 and557 may be sections of tube or coils, for example. Thus,distal tip257 ofcore wire150 is free to rotate withinextended coil tip300, but whendistal section158 ofcore wire150 is loaded in tension,bushing557 will push onbushing538, allowingsection158 ofcore wire150 to pulldistal tip137.
• FIG. 6 illustrates another exemplary embodiment of the present invention having an[0077]extended coil tip300, thisembodiment having coil600 with a substantially circular cross section.Coil600 may be made of a substantially radiopaque material. As illustrated, such an embodiment may also comprisecoil200, which may be an edge wound coil, and may have a substantially rectangular cross section as shown.Coil200 in this embodiment may be made of a substantially radiopaque material and may provide additional radiopacity to that ofcoil600.Coil200 may also contribute to the joint betweentubular member130,coil600,core wire150, or some combination of these components. Solder or adhesive347 may bond totubular member130,coil200,coil600,core wire150, or some combination of these. As an example, in the embodiment illustrated, solder or adhesive347 is located at both ends ofcoil200. Solder or adhesive347 may also be used tobond coil600,distal end137,core wire150,coil200, or some combination of these components, atdistal tip137,distal end138, ordistal tip257. In other embodiments, a second tubular member (slotted or otherwise) may be used in lieu ofcoil200,coil600, or both.
• Another exemplary embodiment of the present invention that may provide adequate radiopacity is illustrated in FIG. 7 and involves a second[0078]tubular member730 of a substantially radiopaque material, which may have good spring characteristics, such as platinum/tungsten, platinum/iridium, or platinum/iridium/rhodium.Tubular member730 may have a plurality ofslots735 configured to maketubular member730 more flexible in bending. For example,slots735 may be like an embodiment ofslots135 described herein fortubular member130.Tubular member730 may be located at thedistal section158 ofcore wire150, and may extend to or neardistal tip257. This embodiment may allow better torque transmission to tip137 than would be provided by anextended coil tip300, and may also provide high radiopacity, when compared with other embodiments such as the embodiment illustrated in FIG. 2. In some embodiments, acoil200 may be located withintubular member730 which may provide additional stiffness, radiopacity, or both.
• The length of[0079]tubular member730 may be, for example, within the range from 0.5 cm to 5 cm. In various embodiments, the wall thickness of the radiopaquetubular member730 may be substantially the same or different than that oftubular member130. Coils orbushings738,757, or both may be used at the ends oftubular member730 tocenter core wire150 in the joint, to facilitate attachment, or both. Solder or adhesive347 may be used to attachdistal end138 oftubular member130,core wire150, or both, totubular member730. Solder or adhesive347 may also be used in some embodiments to attachtubular member730 todistal tip137 ofguidewire100,distal tip257 ofcore wire150, or both.
• Still another exemplary embodiment of the present invention that may provide adequate radiopacity is illustrated in FIG. 8. In this exemplary embodiment,[0080]core wire150 is terminated atdistal tip257 proximal todistal end138 of the micromachinedtubular member130, or proximal todistal tip137. Thus the full lumen diameter oftubular member130 distal todistal tip257 ofcore wire150, or a greater part of this diameter, may then be available to be filled with radiopaque material. This substantially radiopaque material may be, as examples, in the form ofdisks801, spheres, coils802, or micromachined or slotted wire.Distal tip257 ofcore wire150 may attach totubular member130, for example, through coil orbushing738, solder, adhesive, or a combination thereof.
• Various embodiments of the present invention include medical devices, such as[0081]guidewire100, with a tip ordistal end138 with a relatively high flexibility, a relatively high tensile strength, or both, as well as methods for constructing such devices. Specifically, in many embodiments of the present invention, it may be desirable that the tip ordistal end138 ofguidewire100, for example, be of low stiffness to prevent perforation or dissection, for example, ofanatomy101 orvasculature105. This may be achieved by grindingdistal section158 ofcore wire150 to a small diameter or by creating a flat or ribbon shaped wire at the distal end. Inguidewire100,tubular member130 may carry the torsion load (e.g., during removal of guidewire100), at least in the section distal to joint140, andsection158 ofcore wire150 may only be required to carry tensile loads in that section. It may also be desirable to allow tubular member130 (rather thansection158 of core wire150) to provide most of the desired bending stiffness in the section distal to joint140 because this may maximize the torque carrying ability oftubular member130.
• Thus, referring to FIG. 9, it may be advantageous to utilize a[0082]section158 ofcore wire150 forguidewire100 that maximizes its tensile strength and minimizes its bending stiffness. This may be achieved by makingsection158 ofcore wire150 from a plurality ofsmaller wires958 which may be braided or twisted together to achieve the same tensile strength as one much larger wire. In other embodiments, strands orwires958 may be parallel. Another embodiment is to utilize a polymer filament with high tensile strength but low stiffness such as polyethylene (for example, SPECTRA fiber from ALLIED SIGNAL) or polypropylene, forsection158 ofguidewire150. The polymer core wire may also be stranded in some embodiments, for example, for additional bending flexibility, and may be twisted, braided, or parallel.
• In embodiments of the present invention wherein[0083]section158 ofcore wire150 has a plurality ofmetal strands958, for example braded or twisted stainless steel cable or wire rope,distal section158 may be attached toproximal section159 ofcore wire150 with solder or adhesive347 as shown in FIG. 9.Distal section158 may also be attached todistal tip137, for example, with solder or adhesive347. In various embodiments,distal section137 may be formed from a ball or hemisphere of solder or adhesive347 surrounding thedistal tip257 ofdistal section158. Embodiments of the present invention whereinsection158 comprises one or more polymer filaments may be similar, except that an adhesive may be used rather than solder. For example, an epoxy may be used. The bond betweensection158 and159 ofcore wire150 may be tensile tested for quality assurance purposes.
• FIG. 10 illustrates another embodiment of the present invention having a relatively high bending flexibility in the tip, but only in one direction of bending. This exemplary embodiment has a flattened[0084]core wire150 at thedistal tip257 ofdistal section158. Specifically, thedistal end257 ofcore wire150 may be flattened to achieve a more flexibledistal tip1057. This may be done on embodiments with or without an extended coil distal tip300 (e.g.,coil200 illustrated in FIG. 3). As used herein, a tip or cross section is considered to be flattened if it has one dimension (perpendicular to the axis) that is at least twice the other dimension (perpendicular to both the axis and to the first dimension). An example of a flattenedtip1057 would be 1 cm long and flattened from a 0.002-inch round core wire (section158) to 0.001-inch×0.003-inch. In various embodiments, the range of flattened length may be from 0.5 to 5 cm, for example. In some embodiments, a portion ofdistal section158 other thandistal tip257 may be flattened. Flattening a section ofcore wire150, for example, from a substantially round cross section, may provide grater flexibility in one plane, while providing less flexibility in a perpendicular plane, both planes passing through the axis ofguidewire100.Distal tip1057 may be flattened by rolling or forging, for example.
• In embodiments having a flattened[0085]distal tip1057, one or more pieces of substantiallyradiopaque material1001 may be located insidetubular member130, for example, atdistal end138.Material1001 may be in the form of one or more pieces which may have a substantially semicircular cross section, be slotted disks, or be in the shape of a coil or a coil with a notch formed in the ID, for example.Material1001 may be located on opposite sides of the substantially flat cross section of thedistal section158 ordistal tip257 ofcore wire150.
• The present invention also includes medical devices having a number of embodiments of joint[0086]140, for example, medical devices such asguidewire100 havingtubular member130 andcore wire150. Various embodiments of joint140 are illustrated, as examples, in FIGS.11-15. The present invention also includes various methods of fabricating these devices, which are described herein. The construction of the proximal joint140 between the micromachined tube ortubular member130 and thecore wire150 in various embodiments of aguidewire100 with these components may be a factor in the performance of theguidewire100. Referring to FIG. 1, joint140 may, in various exemplary embodiments, transfer the torque from theproximal section159 of thecore wire150 to theproximal end139 oftubular member130. In many embodiments, it may be desirable that joint140 be sufficiently short, flexible or both, so as to not adversely affect the bending stiffness profile or characteristics ofguidewire100.Joint140 may, in an exemplary embodiment of the present invention, also be strong and rugged enough to undergo the simultaneous or separate application of torsion, tension, and bending that may occur during use.
• Referring now to FIGS.[0087]11-15, common to various embodiments of joint140 may be the use of a coil or section ofcoil1141circumscribing core wire150 and at least partially insidetubular member130 to strengthen joint140 betweencore wire150 andtubular member130. Section orcoil1141 may be located at least part way insideproximal end139 oftubular member130 as shown, and may be stretched, for example, with a pitch of from 1.5 to 5 times the diameter of the wire from whichcoil1141 is made.Coil1141 may be attached tocore wire150 andtubular member130 withsolder1147, adhesive1148, or both. In some embodiments,coil1141 may be attached tocore wire150 withsolder1147, and then attached totubular member130 with adhesive1148. Such a joint140 may be stronger than adhesive1148 alone because adhesive1148 may flow in and aroundcoil1141 and in some embodiments also cuts orslots135 intubular member130 and create a mechanically interlocked structure that may have strength even in the event of a complete lack of microscopic adhesion of adhesive1148 tocore wire150,tubular member130, or both.Coil1141 may be made from a metal, for example, stainless steel, or in some embodiments, a substantially radiopaque material such as platinum or tungsten.
• Various embodiments of the present invention may have one or more intermediate bonds between[0088]core wire150 andtubular member130. In such embodiments of the present invention,tubular member130 may be bonded (e.g., with adhesive1148) directly tocore wire150, or to a coil, which may be similar tocoil1141. Such bonds may be, for example, at one or more points intermediateproximal end139 anddistal end138 oftubular member130. These bonds may transfer torsional or axial forces or both between the two structural members (tubular member130 and core wire150). This embodiment may be implemented, for example, in neuro guidewires.
• In[0089]exemplary embodiment1240 of the present invention illustrated in FIG. 12, joint140 may be constructed at least partially within a taperedportion1253 ofcore wire150. Amesial coil1243, aproximal coil345, or both may also be soldered tocore wire150, for example, in the locations shown. In alternate embodiments,coil1141 may be part of mesial coil1243 (but may have a different pitch) or may be a separate coil.Mesial coil1243 may be a marker coil, such ascoil200 illustrated in FIG. 3. It may be advantageous in some embodiments to terminate a marker coil (e.g.,200) and begin another coil (e.g.,mesial coil1141 or1243) of another material. For instance, one material may be less expensive than the other, but may be suitable for use in part of the coil. For example, aplatinum marker coil200 could be terminated and astainless steel coil1141 could continue in its place. In addition, or in the alternative to a reduction in material cost, using another material may provide more compressive strength or stiffness to a medical device such asguidewire100. Such an embodiment may be implemented, for example, in a coronary wire.
• In order to provide a smoother diameter transition, particularly for embodiments of[0090]guidewire100 that have a relatively short micromachinedtubular member130, aproximal coil345 may be used.Proximal coil345 is shown, for example, in FIGS. 3 and 12-15.Proximal coil345 may have an outside coil diameter that may be about the same as that ofproximal section159 ofcore wire150, slottedtubular member130, or both.Proximal coil345 may be made, for instance, of stainless steel or other metals. In various exemplary embodiments, the length ofproximal coil345 may range from 1 to 30 cm. The termination ofproximal coil345 on its proximal end may be, for example, at the point where the inner diameter ofproximal coil345 matches the outer diameter ofcore wire150. This embodiment of the present invention may be implemented, for instance, in a coronary wire.
• In[0091]embodiments having solder1147 and adhesive1148, the quantity ofsolder1147 in the spaced or stretched coil1141 (orsection1141 of the mesial coil1243) may be controlled so thatcoil1141 may be soldered tocore wire150 butsolder1147 does not completely fill the spaces between the loops ofcoil1141.Tubular member130 may then be slid overcoil1141,mesial coil1243, or both, and may butt up againstproximal coil345. Adhesive orglue1148 may then be wicked into the space between the core wire and the tube in the location shown, attachingcore wire130 at itsproximal end139 tocoil1141 andcore wire150.Adhesive1148 may form a mechanical interlock againstcoil1141, withinslots135, or both.
• Referring to FIG. 13, which illustrates another exemplary embodiment of joint[0092]140,joint embodiment1340 may be constructed over a feature incore wire150 or an abrupt change in cross-sectional dimension or diameter, such as aridged section1351 ofcore wire150, which may be located betweenproximal section159 anddistal section158. Ridge or ridgedsection1351 may be a feature incore wire150 configured to facilitate mechanical interlock of solder or adhesive347, for example, used for joint140. Other such features or abrupt changes in cross-sectional dimension or diameter may include steps, ridges of other shapes (e.g., shorter in axial length), grooves, slots, changes in cross section (e.g., round to polygonal), or a combination of such features.
• [0093]Ridged section1351 may be formed, for example, by grinding down the remainder ofcore wire150, or by installing a coil or sleeve oncore wire150, which may be soldered, welded, bonded, shrunk fit, cast, or crimped in place. Acoil1141, which may be part of amesial coil1143, may be soldered tocore wire150 just distal to theridge1351 as shown. Again, the quantity ofsolder1147 in the spacedcoil section1141 of themesial coil1143 may be controlled so that thecoil1141 may be soldered to the wire but, in some embodiments,solder1147 may not fill the spaces between the loops ofcoil1141. In some embodiments, aproximal coil345 may be soldered to theproximal section159 ofcore wire150, toridge1351, or both.Tubular member130 may then be installed overcore wire150, for instance, to the point whereproximal end139 butts up toproximal coil345. Adhesive orglue1148 may be wicked into the space betweentubular member130 andcore wire150 in the location shown.
• The embodiment of joint[0094]140 illustrated in FIG. 11 may have the advantage of not requiring a specific feature or abrupt change in cross-sectional dimension or diameter like a step, ridge, or shelf on the ground section ofcore wire150. But this embodiment may have the disadvantage of having a point at or just proximal toproximal end139 oftubular member130 where the bending stiffness of the assembledguidewire100 may be lower than the adjacent portions ofguidewire100. In some applications, this may lead to fatigue and failure at joint140 in use.Joint embodiment1340, illustrated in FIG. 13, may have a short extra stiff segment at theproximal end139 oftubular member130 atridge1351 incore wire150. Thisembodiment1340, however, may yield a more rugged joint140 when exposed to repeated bending stress. In some embodiments, the diameter ofridge1351, other factors, or a combination thereof, may be selected to obtain a relatively continuous bending stiffness in the area of joint140.
• FIG. 14 illustrates still another exemplary embodiment of the present invention, joint[0095]140embodiment1440, which, like the embodiment illustrated in FIG. 11, may be constructed on a tapered portion ofcore wire150.Mesial coil1143 andproximal coil345 may be attached tocore wire150 in the locations shown in FIGS. 11 and 14, for example, with adhesive1148,solder1147, or both. In embodiments having bothsolder1147 and adhesive1148, the quantity ofsolder1147 in the spacedcoil section1141 ofmesial coil1143 may be controlled so thatsolder1147 does not fill the spaces between the loops ofcoil1141. Inembodiment1440,proximal coil345 may have a short spaced-apartregion1442 at its distal end that screws into a matchinghelical cutout1432 intubular member130.Solder1147 or adhesive orglue1148 may be wicked into the space betweentubular member130 andcore wire150 in the location shown. Thus, joint140embodiment1440 may interlockproximal coil345 withtubular member130, which may provide a stronger connection than some alternatives.
• FIG. 15 illustrates yet another exemplary embodiment of the present invention, joint[0096]140embodiment1540, which may be constructed at an abrupt change in cross-sectional dimension such asstep1551 in the diameter ofcore wire150.Step1551 may be a feature incore wire150 configured to facilitate mechanical interlock of solder or adhesive347, for example, used for joint140. In various embodiments,step1551 may be a relatively steep taper as shown, or may be a square step in diameter, i.e., with a surface perpendicular to the axis ofcore wire150. Radiused inside corners (for example, such as those shown forridge1351 in FIG. 13) may reduce stress concentration.Coil1141 orsection1141 ofmesial coil1143 may be attached tocore wire150 at or just distal to step1551 as shown. As in other embodiments,solder1147, adhesive1148, or both, may be used to attach coil orsection1141 tocore wire150. In some embodiments, the end ofproximal coil345 may be attached proximal to step1551 as shown.Tubular member130 may then be installed oncore wire150 to the point where it butts up toproximal coil345.Solder1147 or adhesive orglue1148 may be wicked into the space betweentubular member130 andcore wire150 in the location shown.Joint140embodiment1540 may be similar to joint140embodiment1340 in that it may reduce or eliminate a potential weak spot atproximal end139 oftubular member130.Embodiment1540 may be less costly to produce because of thestep1551 rather than aridge1351, but someembodiments1540 may be not be quite as rugged as some embodiments of1351, for example, in embodiments having a radial gap betweentubular member130 andcore wire150 at the extreme proximal end oftubular member130.
• [0097]Joint140 withstep1551 may be useful, for example, on guidewires that have a short length oftubular member130, for instance, a coronary wire with a 5cm tubular member130. In such an exemplary embodiment,core wire150 may be substantially smaller than the inner diameter oftubular member130.Step1551 incore wire150 may allow joint140 atproximal end139 oftubular member130 to have sufficient strength in bending.Step1551 incore wire150 may, as examples, either be ground in place oncore wire150, or a distal tube may be slid overproximal section159 ofcore wire150 and soldered or bonded, for instance, tocore wire150 as a separate operation.
• The present invention also includes various embodiments of arrangements and configurations of features making it more flexible in bending, for example,[0098]slots135. As mentioned with reference to FIG. 1,tubular member130 may have a plurality ofslots135 formed or cut intotubular member130 to make it more flexible in bending. Referring to FIG. 2,slots135 may be formed part way throughtubular member130, leaving axial beams orsegments236 joiningrings234. Various embodiments oftubular member130 are illustrated in FIGS.16-19, with various configurations and arrangements ofslots135, rings234, andsegments236. Specifically,slots135 may be formed in groups of two, three, ormore slots135, which may be located at substantially the same location along the axis oftubular member130, and may be substantially perpendicular to the axis. FIG. 2 illustrates an exemplaryembodiment having groups235 of twoslots135 each, and FIG. 16 illustrates an exemplary embodiment having groups1635 of threeslots135 each. Aring234 is formed between any two adjacent groups (e.g.,235 or1635) ofslots135, andadjacent rings234 are attached by a number ofsegments236 equal to the number ofslots135 in thegroup235. Withgroups235 of twoslots135, bending oftubular member130 may result from distortion ofsegments236, rings234, or both. Withgroups235 of three or more slots, bending oftubular member130 results more from distortion ofrings234. Thus, fatigue is less likely occur atsegments236 in embodiments having three ormore slots135 pergroup235.
• [0099]Adjacent groups235 or1635 ofslots135 may be rotated by an angle relative to each other (i.e., from the adjacent orprevious group235 or1635) about the axis oftubular member130 as illustrated in FIG. 3 and FIG. 16.Adjacent groups235 consisting of twoslots135 may be rotated by and angle of about 90 degrees, for example, and adjacent groups1635 consisting of three slots may be rotated by an angle of about 60 degrees. Thus,segments236 may approximately line up in the axial direction with the midpoints of theadjacent slots135. In general, this angle of rotation may be about 180 degrees divided by the number ofslots135 in the group (e.g.,group235 or1635).
• In some embodiments, the angle of rotation may be slightly more or slightly less than the angle given by this formula. Thus,[0100]segments236 may be a slight angle from lining up with the midpoint ofslots135 in adjacent groups. Thus,slots236 may form a helical pattern alongtubular member130. This slight angle may be, for example, 1 to 20 degrees forgroups235 of twoslots135 each, and may be the same or less for groups having more than twoslots135. In general, the angle of rotation may be 180 degrees plus or minus no more than 40 degrees, that quantity divided by the number ofslots135 in the group (e.g.,group235 or1635). In other words, the angle of rotation may be within the range of 140 to 220 degrees divided by the number ofslots135 in the group (e.g.,group235 or1635). In other embodiments, the angle of rotation may be 180 degrees plus or minus an angle between 1 and 25 degrees, that quantity divided by the number ofslots135 in the group (e.g.,group235 or1635). In other embodiments, the angle of rotation may be 180 degrees plus or minus no more than 5 degrees, that quantity divided by the number ofslots135 in the group (e.g.,group235 or1635). In still another embodiment, the angle of rotation may be 180 degrees divided by the number of slots in the group, plus or minus no more than 10 degrees or 1 to 10 degrees.
• FIG. 17 illustrates an exemplary embodiment wherein[0101]groups235 of twoslots135 each are rotated by an angle of approximately 85 degrees from theadjacent group235. Thus,group235 at section B is rotated approximately 85 degrees fromgroup235 at section A,group235 at section C is rotated approximately 85 degrees fromgroup235 at section B, andgroup235 at section D is rotated approximately 85 degrees fromgroup235 at section C. Thus, in this embodiment,segments236 form a helical pattern alongtubular member130.Slots135 may be formed by cutting or grinding, for example, with a semiconductor dicing blade. For instance, eachslot135 in agroup235 may be cut in turn by rotatingtubular member130. Thentubular member130 may be advanced axially, rotated the desired amount, and the axiallyadjacent group235 ofslots135 may be cut. In the embodiment illustrated in FIG. 17, this desired amount would be 85 degrees. Rotating by 95 degrees would provide the same result, except that the helical pattern would be in the opposite direction.
• In some embodiments of the present invention, it may be advantageous to form[0102]slots135 of one or more of the configurations and arrangements described herein in a solid member or wire rather than in a tubular member (e.g., tubular member130). For example,groups235 of twoslots135 each may be formed in a solid circular cylinder or wire, which may be formed from nitinol or stainless steel, for example. In some embodiments, different materials may be joined, for example, a stainless steel proximal section and a nitinol distal section, both of which or just the distal section being slotted. Tapering or changes in diameter may also facilitate a lower bending stiffness at the distal end. In comparison with a slottedtubular member130, for example, a slotted solid member may have greater tensile strength due to the center portion.
• As an exemplary embodiment,[0103]slots135 may be formed in part or all ofproximal section159 ordistal section158 ofcore wire150 of the exemplary embodiment″s described or illustrated herein. In one embodiment, such a slotted wire may form a guidewire, which may have a coil (e.g., an external radiopaque coil200), tubular member (e.g.,130), coating, or a combination of these. Some embodiments may be encapsulated with a radiopaque polymer compound, for example. In some embodiments, there may be a slotted wire in a slottedtubular member130, in a radiopaque slotted tubular member730 (shown in FIG. 7), or both. In another example, such a slotted solid member or wire may be formed of a substantially radiopaque material and used as a marker, for example, in lieu ofdisks801 or coil802 in the exemplary embodiment illustrated in FIG. 8.
• In some embodiments,[0104]slots135 may be substantially equally spaced around the axis, as shown, fple, in FIGS. 2, 3, and16. In such embodiments, eachslot135 in agrop235 may be substantia, or bothlly than example, as e same size (e.g., width and depth). However, as illustrated in FIG. 18, in some embodiments,slots135 may be spaced unequally around the axis, and may be of unequal sizes. As illustrated in FIG. 18A,slot1835amay be substantially deeper thanslot1835b, thus resultings1836 being offset from the center oftubular member130. In the embodiment illustrated in FIG other (every second)group236 has unequallysized slots135 that are unequally spaced around the axis. In the embodiment illustrated in FIG. 19, everygroup235 shown has unequallysized slots135 that are unequally spaced around the axis. Further, in the embodiment illustrated in FIG. 18. all of the groups ofunequal depth slots1835aand1835bare formed so thatsegments1836 are offset in substantially the same direction relative to the axis oftubular member130. In contrast, the embodiment illustrated in FIG. 19 shows thatunequal depth slots1835aand1835bmay be formed so thatsegments1836 are offset in different directions relative to the axis oftubular member130. In some embodiments, for example, a plurality of directions equally spaced around the axis may have equal numbers ofdeeper slots1835a. Such embodiments may have essentially equal bending characteristics around the axis. Isome embodiments of the present invention, slots1836bmay be omitted, resulting in oneslot1835apergroup235.
• FIG. 20 illustrates an e, or may have equally[0105]sized slots135 unequally spaced around the axisxemplary embodiment of the present invention having atubular member130 with unequally spaced andsized slots1835aand1835bof the configuration illustrated in FIG. 18. Other embodiments may haveslots135 as shown in FIG. 19, for another example. Steerablemedical device2000 may includetubular member130,core wire150,control knob2052, andtip137.Tubular member130 andcore wire150 may extend coaxially fromcontrol knob2052 todistal tip137. In this embodiment,tubular member130 may consist of two or more tubes or tubular members attached with one or more joints, such as joint140, or may consist of one tube, which may be slotted at least atdistal end138. For example, embodiments may be arranged similarly to what is shown in FIG. 7 (with the twotubular members130 and730 in line), similarly to what is shown in FIG. 21 (with the twotubular members130 and2130 arranged coaxially), similarly to what is shown in FIG. 22 (with the two tubular members arranged partially coaxially), or similarly to what is shown in FIG. 24 (with the twotubular members130 and2439 in line or being sections of the same tubular member).Core wire150 may be stainless steel, nitinol, or a combination, as examples, and may have single or multiple strands.
• [0106]Medical device2000 may be steerable by controlling the shape or amount or angle ofbend133 by applying tension tocore wire150, for example, withcontrol knob2052. Increasing the angle ofbend133 may be accomplished, for example, by pulling on or turning (screwing)control knob2052 relative totubular member130, inducing bending at unequally sized or offsetslots1835aand1835b. Unequallysized slots1835aand1835bmay be located along a portion oftubular member130, for example, wherebend133 is desired. This location may be at or neardistal end138, for example. In one embodiment,medical device2000 is a guidewire, andcontrol knob2052 is removable to guide a catheter overdevice2000. In other embodiments,tubular member130 may function as a catheter, which may be usable without a separate guidewire.
• Further, in various embodiments of the present invention, it may be advantageous to reduce the compressive stiffness along the axis or column strength or stiffness of at least part of the medical device or[0107]tubular member130, for example, to avoid dissection ofvasculature105. In the embodiment illustrated in FIG. 18, a compressive load ontubular member130 may cause it to tend to bend in the direction ofslots1835a. In contrast, in the embodiment illustrated in FIG. 19, a compressive load ontubular member130 may cause it to form a helical shape, bend in a direction determined byanatomy101, or just shorten in length along its axis. The present invention also includes various features for obtaining the desired torsional and bending stiffness of a medical device such asguidewire100. Accordingly, FIG. 20 also illustrates a feature of many embodiments of the present invention, namely proximal hypotube orsleeve2062.Sleeve2062 may be shrunk fit in place or may be bonded to tubular member130 (or toproximal section159 ofcore wire150, for example, in the embodiment illustrated in FIG. 1), for example with an adhesive, at least at the ends ofsleeve2062.Sleeve2062 may be a second tubular member, and may increase the stiffness, strength, or both, of the part or parts it is bonded to (e.g., tubular member130), in torsion, bending, tension, or a combination thereof. In some embodiments,sleeve2062 may be made of a stiffer material than that to which it is bonded. For example, in the exemplary embodiment illustrated in FIG. 20,tubular member130 may be nitinol, andsleeve2062 may be stainless steel. In such embodiments,sleeve2062 may cover only the proximal end of the medical device ortubular member130. In some embodiments,sleeve2062 may be at least partially slotted, or its outside diameter tapered, to reduce or control its bending stiffness. For example,sleeve2062 may be slotted along its length or at its distal end similarly totubular member130. In some embodiments, control knob2052 (or chuck152) may attach or clamp toproximal sleeve2062. In some embodiments, such as catheters,sleeve2062 may substantially comprise a polymer material, and may sealslots135.
• FIG. 21 illustrates another exemplary embodiment of the present invention having[0108]tubular member2130, which may share a common axis withtubular member130.Tubular member2130 may be concentric withtubular member130 as shown.Tubular member2130 may be insidetubular member130, andtubular member2130 may have a plurality ofslots2135 configured to maketubular member2130 more flexible in bending.Tubular member2130 may be slotted similarly totubular member130, andslots2135 may be similar in arrangement, configuration, or both, toslots135.Tubular member2130 may haveproximal end2139 which may be at or near joint140, anddistal end2138, which may be located proximal todistal end138 oftubular member130 as shown. A substantially radiopaque marker such ascoil200 may be located atdistal end2138 or distal totubular member2130.Tubular member2130 may be made of materials identified herein fortubular member130, and may be attached tocoil wire150,tubular member130, or both, atproximal end2139,distal end2138, or both, for example, with solder or adhesive347.
• Still referring to FIG. 21, in some embodiments of the present invention, part or all of[0109]tubular member130,tubular member2130, or both, may lackslots135 or2135. For instance, one tubular member (130 or2130) may lack slots (135 or2135) over its entire length, while the other tubular member (130 or2130) may contain slots (135 or2135). In some such embodiments, part or all oftubular member130,tubular member2130, or both, may containslots135 or2135 at one or both ends, for example, to smooth the transition in stiffness at that location. In some embodiments, portions oftubular member130,tubular member2130, or both, that lackslots135 or2135, may be tapered, for example by grinding, to reduce or control the bending stiffness in such locations.
• As illustrated, some embodiments of the present invention having two tubular members (e.g.,[0110]130 and2130) may have one or more abrupt changes in cross-sectional dimension or diameter ofcore wire150, such assteps2151,2152, or both, which may be at the proximal ends of the tubular members. For example,tubular member2130 may abut againststep2151, andtubular member2130 may abut againststep2152.Steps2151 and2152 may be located farther apart along the axis ofcore wire150 than what is shown. Other embodiments may have a gradual taper incore wire150 at joint140, may comprise coils such as those illustrated in other figures, or may omitsection159 ofcore wire150 proximal to proximal ends139 and2139. Some embodiments having two tubular members may be used in conjunction withextended coil tip300 described above.
• The embodiment of the present invention with concentric[0111]tubular members130 and2130 illustrated in FIG. 21 may have better resistance to kinking and better fatigue life than other alternatives, such as alternatives having a singletubular member130 withfewer slots135 or a greater wall thickness.Tubular members130 and2130 may be slotted separately or at the same time (e.g., in concentric configuration). In an exemplary embodiment,tubular member130 may have an OD of 0.0135 inches and an ID of 0.0096 inches, andtubular member2130 may have an OD of 0.0095 inches and an ID of 0.006 inches.
• In some embodiments of the present invention, it may be desirable for all or part of the outside diameter of a medical device such as[0112]guidewire100 to taper gradually or incrementally (e.g., by stepping) to a smaller OD atdistal tip137. This tapering may facilitate producing a lower bending stiffness in the distal direction. In addition, a smaller outside diameter in the distal end may be desirable, for example, where the medical device is to navigate through progressivelysmaller vasculature105, and less space is available wheredistal end138 is to navigate. As mentioned with reference to FIG. 1,tubular member130 may have a smaller outside diameter than at least part ofproximal section159 ofcore wire150. In some embodiments, for example,core wire150 may taper gradually or incrementally fromproximal end154 to joint140, for example, and may have a larger OD atend154 than at joint140. In another embodiment,proximal section159 ofcore wire150 may have a substantially constant OD, which may be larger than the OD oftubular member130.
• In the alternative, or in addition, the OD of[0113]tubular member130 may taper in the distal direction. This taper may be a continuous gradual taper or an incremental taper, for example. The inside diameter (ID) oftubular member130 may also reduce in the distal direction, or may remain constant. Thus, the wall thickness oftubular member130 may also reduce gradually or incrementally in the distal direction alongtubular member130, or in some embodiments, may remain substantially constant.
• [0114]Tubular member130 may be tapered, for example, by machining or grinding its outside surface. In another embodiment, a plurality of different outside diameter sections oftubular member130 may be joined together forming atubular member130 that tapers incrementally, for example, in one or more steps or tapered portions. The different outside diameter sections may butt together for joining or may overlap for a distance concentrically, for example, and may be joined with an adhesive or solder joint or a weld, for example. In such incrementally tapered embodiments oftubular member130, the steps or changes in outside diameter may be machined or ground to form a chamfer or gradual taper, either along the entire length of tubular member130 (i.e., a continuous taper) or between sections having substantially constant diameters (i.e., an incremental taper). Such chamfers or gradual tapers at changes in diameter may reduce friction and facilitate navigation of the medical device throughanatomy101. Chamfering or tapering these changes in diameter may also produce more gradual changes in stiffness, reduce stress concentration, or both.
• As an exemplary embodiment, and as shown best in FIG. 22,[0115]distal end2138 of smallerconcentric tubular member2130 may extend substantially distal todistal end138 of largertubular member130.Distal tip137 may be approximately the same size (e.g., diameter) as the OD ofdistal end2138 oftubular member2130, and may attach thereto, todistal section158 ofcore wire150, or both. In some embodiments,proximal end2139 oftubular member2130 may be where shown in FIG. 21, while in other embodiments,proximal end2139 oftubular member2130 may be just proximal todistal end138 oftubular member130 as shown in FIG. 22. For example,proximal end2139 oftubular member2130 may be far enough proximal todistal end138 oftubular member130 to allow space for a satisfactory joint betweenproximal end2139 oftubular member2130 anddistal end138 oftubular member130. Such a joint may use solder or adhesive347, for example. In some embodiments, a bushing orcoil2238 may be located betweentubular member130,tubular member2130, or both, or between one or both tubular members (e.g.,130 and2130) anddistal section158 ofcore wire150.Tubular member130,tubular member2130, or both, may be attached todistal section158 ofcore wire150 at that location, for example with solder or adhesive347 (or a combination of both), which may surround bushing orcoil2238.
• Referring back to FIG. 21, also illustrated is a feature of many embodiments of the present invention,[0116]sleeve2162.Sleeve2162 may be similar tosleeve2062 illustrated in FIG. 20 and described above.Sleeve2162 may be substantially comprised of a flexible material such as a polymer, and may cover some or all ofslots135 intubular member130.Sleeve2162 may cover all or part ofproximal section159 ofcore wire150 as well, or instead. Further, in embodiments whereintubular member2130 extends distal todistal end138 oftubular member130,sleeve2162 may extend distal todistal end138 oftubular member130. Thus,sleeve2162 may cover at least part oftubular member2130 andslots2135 therein. In some such embodiments,sleeve2162 may taper or be formed with a smaller OD distal todistal end138 oftubular member130.
• [0117]Sleeve2162 may be shrunk overtubular member130,tubular member2130,proximal section159 ofcore wire150, or a combination thereof, or may fit loosely (e.g., with a clearance fit) over other components, and may be affixed for example, with an adhesive.Sleeve2162 may be affixed, for example, at both of its ends. In some embodiments,sleeve2162 may be affixed at one or more intermediate locations as well.Sleeve2162 may improve the lubricity oftubular member130 by coveringslots135 and preventing friction betweenslots135 andanatomy101.Sleeve2162 may also sealslots135, for example, to facilitate using the medical device as a catheter. Further,Sleeve2162 may increase the stiffness or strength of the medical device, may increase the OD of the medical device, or a combination of these effects. In comparison with other changes that may increase stiffness or OD,sleeve2162 may avoid reducing the maximum radius of bend that can be achieved without plastic deformation, may avoid reducing fatigue life for a given radius of bend, or both.
• In still another exemplary embodiment of the present invention illustrated by FIG. 21,[0118]tubular member2130 may be a polymer tube. Apolymer tubular member2130 may not requireslots2135, but may increase stiffness without reducing maximum elastic bending radius or fatigue life of the medical device for a given radius of bend.Tubular member2130 withoutslots2135 may facilitate use of the medical device as a catheter, for example, in embodiments lackingcore wire150 orproximal section159 thereof. In embodiments having at leastdistal section158 ofcore wire150,tubular member2130 may also serve as a spacer betweentubular member130 anddistal section158 ofcore wire150, and may keepsection158 ofcore wire150 relatively centered withintubular member130.Tubular member2130 may prevent contact betweentubular member130 andcore wire150, reducing friction or wear. Apolymer tubular member2130 may be shrunk fit overdistal section158 ofcore wire150, or may fit loosely thereover (e.g., with a clearance fit).
• Another exemplary embodiment of the present invention having a second tubular member is illustrated in FIG. 23, which may be an alternate embodiment of[0119]guidewire100. In this embodiment,second tubular member2330 may be located in line withtubular member130 and may be proximal totubular member130 as shown.Core wire150 may extend throughtubular member2330 and at least part oftubular member130, and may further extend proximal totubular member2330 as shown.Core wire150 may have anintermediate section2356 betweenproximal section159 anddistal section158, andtubular member2330 may be located atintermediate section2356. The diameter ofcore wire150 atsection2356 may be less than the diameter ofcore wire150 atsection159, greater than the diameter ofcore wire150 atsection158, or both. There may be an abrupt change in cross-sectional dimension or diameter (OD) ofcore wire150 betweenproximal section159 andintermediate section2356 as shown, or there may be a gradual taper at that location. Similarly, there may be an abrupt change in cross-sectional dimension or diameter (OD) ofcore wire150 betweenintermediate section2356 anddistal section158, also as shown, or there may be a gradual taper at that location as well.Core wire150 may have a great enough diameter atintermediate section2356 to provide adequate strength and stiffness in torsion, as well as in bending.
• As illustrated, such a[0120]guidewire100 may also have a substantially radiopaque marker, such ascoil200, located at or neardistal tip137.Tubular member2330 my be polymer, may be shrunk fit oversection2356 ofcore wire150, or may be attached with an adhesive.Tubular member2330 may be attached just at its ends, at intermediate locations as well, or along the entire length or at least a portion oftubular member2330. The use of apolymer tubular member2330, ortubular member2330 made of a non-superelastic material, may reduce the necessary length oftubular member130, reducing the cost ofguidewire100.Tubular member2330 may also provide a more lubricious surface (e.g., in comparison with the surface of slotted tubular member130), thus reducing friction betweenguidewire100 andanatomy101 at that location along the longitudinal axis. Further,tubular member2330 may provide a larger diameter and stiffer section thansection2356 ofcore wire150 alone, thus reducing the likelihood of dissection ofvasculature105 and increasing the stiffness ofguidewire100 at that location without reducing bending capability or fatigue resistance.
• In other embodiments,[0121]tubular member2330 may be slotted, and may be made of a superelastic metal. In some embodiments,tubular member130 may be made of a substantially radiopaque material. In embodiments wheretubular member2330 is metal, it may be attached to other metal components with either solder or adhesive337, for example.
• FIG. 24 illustrates another exemplary embodiment of the present invention having a proximal portion of[0122]tubular member130 or asecond tubular member2439 which may be attached totubular member130. Proximal portion oftubular member130 orsecond tubular member2439 may lackslots135, but may be tapered at least at its OD in the distal direction as shown, providing a varying bending stiffness along at least part of its length. Thus, the wall thickness of proximal portion oftubular member130 orsecond tubular member2439 may become thinner in the distal direction, at least over part of proximal portion orsecond tubular member2439. Tapering proximal portion oftubular member130 orsecond tubular member2439 may also serve to minimize or avoid a substantial change in stiffness at the proximal end of thesection containing slots135. This may serve to reduce fatigue at that location or at the most proximally located slot orslots135.
• In embodiments wherein distal portion of[0123]tubular member130 orsecond tubular member2439 is a separate piece fromtubular member130, there may be a joint2440 between secondtubular member2439 andtubular member130, an exemplary embodiment of which is shown. Bushing orcoil2441 may be located part way insidesecond tubular member2439 and part way insidetubular member130, and may be attached to each tubular member (i.e.,2439 and130) with solder or adhesive347. In embodiments havingcore wire150, bushing orcoil2441 may also serve as a spacer centeringcore wire150, and may be attached tocore wire150, for example, with solder or adhesive347. In another exemplary embodiment of joint2440,second tubular member2439 may be welded totubular member130.
• Distal portion of[0124]tubular member130 orsecond tubular member2439 may have an un-tapered (e.g., constant OD) section at its proximal end. In various embodiments,chamfers231 may be provided at one or both ends of portion ormember2439. In embodiments wherein distal portion oftubular member130 orsecond tubular member2439 is part oftubular member130, the assembly (i.e., tubular member130) may be made of a superelastic material such as nitinol. In embodiments with aseparate tubular member2439,tubular member130,tubular member2439, or both may be made of a superelastic material such as nitinol. Ortubular member2439 may be made of a polymer or stainless steel, for example. In some embodiments,tubular member130 may be made of a substantially radiopaque material.
• Referring once again to FIG. 22, also illustrated is another feature of various embodiments of the present invention, namely[0125]coil2266.Coil2266 may share a common axis withtubular member130, tubular member2130 (shown) or both. Further,coil2266 may be concentric with and external totubular member130, tubular member2130 (shown) or both.Coil2266 may extend distally fromtubular member130 as shown. Thus,coil2266 may form anextended coil tip300 having asecond tubular member2130.Coil2266 may be wound from wire having a substantially round cross section as shown, or may be anedge wound coil200 as described above and shown in other figures. Alubricious coating2269 may be applied overcoil2266, which may occupy all or part of the space between the windings ofcoil2266. The same may be true forcoil345 illustrated in FIGS.12-15, for example.
• The rounded bumps of[0126]coil2266 or345 may provide a lower friction surface than the slotted exterior surface oftubular member2130 or130, for example. In addition, coating2269 between the windings ofcoil2266 may provide lubricity even whenlubricious coating2269 from the outermost surface has been worn away. Embodiments of the present invention having anextended coil tip300, (illustrated in FIG. 3) may also have acoil2266, alubricious coating2269, or both overcoil200.Coil2266 may be particularly beneficial to lubricity in such embodiments whereincoil200 has a cross section having sharp corners at its outside diameter.Coil2266 may comprise a substantially radiopaque material, or a radiopaque material may be located insidecoil2266, for example,marker coil200 shown insidetubular member2130.
• The above embodiments are illustrative of the present invention, but are not intended to limit its scope. Numerous modifications and alternative arrangements may be devised by those skilled in the art without departing from the spirit and scope of the present invention, and the appended claims are intended to cover such modifications and arrangements.[0127]

Claims (72)

1. A medical device for navigation through anatomy, the medical device comprising:

an elongate body having a proximal end, a distal end, and a longitudinal axis extending at least from the proximal end to the distal end; and

a helical first coil formed from wire having a substantially non-circular cross section; and

said cross section having a greater dimension in the radial direction than in the axial direction.

2. The medical device ofclaim 1, said body comprising a tubular member having a plurality of slots configured to make said tubular member more flexible in bending.

3. The medical device ofclaim 1, said first coil being located at or near said distal end, said first coil substantially comprising a substantially radiopaque material.

4. The medical device ofclaim 3, said body comprising a tubular member having a plurality of slots configured to make said tubular member more flexible in bending, said body further comprising a core wire, at least part of said core wire being located inside said tubular member, at least a portion of said core wire being located inside said first coil.

5. The medical device ofclaim 1 further comprising a second coil sharing said longitudinal axis with at least said body.

6. The medical device ofclaim 1, said medical device being a guidewire.

7. A medical device configured to be guided to a target location in anatomy, the medical device comprising:

a first tubular member having a proximal end and a distal end;

a core wire extending proximally from said first tubular member, said core wire being attached with a joint to said first tubular member at least at said proximal end, said joint comprising:

a first coil circumscribing said core wire, said first coil being at least partially inside said first tubular member, and

at least one of solder and adhesive.

8. The medical device ofclaim 7, said core wire being metal and said first coil being metal, said joint comprising solder attaching said first coil to said core wire and adhesive attaching at least one of said first coil, said core wire, and said solder, to said first tubular member.

9. The medical device ofclaim 7, said first tubular member having superelastic properties and at least part of said distal end being heat treated to reduce said superelastic properties at said distal end.

10. The medical device ofclaim 7 said first tubular member comprising a plurality of slots formed in said first tubular member, at least a plurality of said slots being substantially perpendicular to said axis, said slots being formed in a plurality of groups, and at least a plurality of said groups comprising a plurality of slots at substantially the same location along said axis.

11. The medical device ofclaim 10, wherein in at least some said groups, at least one said slot is substantially deeper than at least one other said slot.

12. The medical device ofclaim 7 further comprising a second tubular member circumscribing at least a portion of said core wire.

13. The medical device ofclaim 7, said first coil being formed from wire having a wire diameter, said first coil having at least a portion of its length with a pitch of at least 1.5 times said wire diameter.

14. The medical device ofclaim 7, said core wire having a tapered portion, said joint being located at least partially within said tapered portion.

15. The medical device ofclaim 7 further comprising a second coil having a larger outside coil diameter than said first coil.

16. The medical device ofclaim 7, said core wire having a feature configured to facilitate mechanical interlock of said at least one of solder and adhesive, said joint being located at said feature.

17. The medical device ofclaim 16, said feature comprising at least one of a step and a ridge.

18. The medical device ofclaim 7, said first tubular member having a chamfer at said proximal end.

19. The medical device ofclaim 7, said core wire further being attached to said first tubular member at said distal end of said first tubular member.

20. The medical device ofclaim 7, said core wire further being attached to said first tubular member at least one location intermediate said proximal end and said distal end.

21. The medical device ofclaim 7, said core wire having a proximal section proximal to said first tubular member, said proximal section having a first outside diameter along at least a majority of its length, and said first tubular member having a second outside diameter along at least a majority of its length, said first outside diameter being larger than said second outside diameter.

22. A medical device configured to be guided to a target location in anatomy, the medical device comprising:

a tubular member having a proximal end and a distal end and a plurality of slots configured to make said tubular member more flexible in bending; and

a core wire having a proximal section extending proximally from said tubular member, and a distal section located inside said tubular member, said core wire being attached to said tubular member at least at said proximal end; and

at least part of said proximal section having a substantially round cross section and at least part of said distal section having a flattened cross section.

23. The medical device ofclaim 22 further comprising substantially radiopaque material located inside said tubular member at said distal end.

24. The medical device ofclaim 23 said substantially radiopaque material having a substantially semicircular cross section and being located on opposite sides of said flattened cross section of said distal section of said core wire.

25. A medical device with a stepped core wire configured to be guided to a target location in anatomy, the medical device comprising:

a tubular member having a proximal end and a distal end and a plurality of slots configured to make said tubular member more flexible in bending; and

a core wire having a proximal section extending proximally from said tubular member, and a distal section located at least partially inside said tubular member, said core wire comprising an abrupt change in cross-sectional dimension between said proximal section and said distal section; and

said core wire being attached to said tubular member at least at said proximal end, said proximal end abutting said abrupt change in cross-sectional dimension.

26. The medical device ofclaim 25 further comprising a coil circumscribing at least a portion of said core wire.

27. The medical device ofclaim 26, said coil being soldered to said core wire, said tubular member being attached at least to said coil with adhesive.

28. A medical device configured to be guided to a target location in anatomy, the medical device comprising:

a first tubular member having a proximal end and a distal end, and a longitudinal axis extending at least from the proximal end to the distal end;

a plurality of slots formed into said first tubular member and configured to make said first tubular member more flexible in bending;

a core wire extending proximally from said proximal end of said first tubular member; and

a first coil extending distally from said distal end of said first tubular member.

29. The medical device ofclaim 28 further comprising a second tubular member sharing said longitudinal axis.

30. The medical device ofclaim 29, said second tubular member extending distally from said distal end of said first tubular member, said second tubular member being at least partially located inside said first coil.

31. The medical device ofclaim 29, said second tubular member comprising a plurality of slots configured to make said second tubular member more flexible in bending.

32. The medical device ofclaim 28, said first tubular member comprising a first portion without said slots and a second portion with said slots, said first portion being proximal to said second portion.

33. The medical device ofclaim 28, said core wire being attached with a joint to said first tubular member at least at said proximal end of said first tubular member, said joint comprising a second coil circumscribing said core wire, and said second coil being at least partially inside said first tubular member; and said joint further comprising at least one of solder and an adhesive attaching said second coil to said core wire and said first tubular member at least to said second coil.

34. The medical device ofclaim 33, said core wire comprising an abrupt change in cross-sectional dimension at said joint.

35. The medical device ofclaim 28, said slots being arranged in groups of three.

36. The medical device ofclaim 28, said first tubular member having a chamfer at said proximal end.

37. The medical device ofclaim 28, said core wire having a distal tip, said distal tip being at least partially flattened.

38. A slotted medical device configured to navigate through anatomy, the medical device comprising:

a first tubular member having a proximal end, a distal end, and a longitudinal axis extending at least from the proximal end to the distal end;

a plurality of groups of slots formed into said first tubular member, at least a plurality of said groups comprising a plurality of slots at substantially the same location along said axis;

at least a plurality of said longitudinally adjacent said groof substantailly equal size and ups being rotated alyt an angle around said axis from the previous said group;

at least a plurality of said groups haviin the axial direction ng at least three slots.

39. The medical device ofclaim 38, each said slot in at least a plurality of said groups being substantially equal spaced around said axis.

40. The medin the axial direction ical device ofclaim 38, the spacing between said groups varying gradually along at least part of said first tubular member providing a varying bending stiffness along at least part of said first tubular member, said groups being more closely spaced at said distal end.

41. The medical device ofclaim 38, at least a plurality of said longitudinally adjacent said groups being rotated at an angle around said axis from the previous said group, said angle being 180 degrees divided by the number of slots in the group, plus or minus no more than 10 degrees.

42. The medical device ofclaim 38, at least a plurality of said groups consisting of three slots.

43. The medical device ofclaim 38 further comprising a core wire disposed within said first tubular member and extending proximal therefrom, the medical device being a guidewire.

44. The medical device ofclaim 43, said core wire being attached with a joint to said first tubular member at least at said proximal end of said first tubular member, said joint comprising a metal first coil soldered to said core wire, said first coil circumscribing said core wire, and said first coil being at least partially inside said first tubular member; and said joint further comprising an adhesive attaching at least said first coil to said first tubular member.

45. The medical device ofclaim 43, said first tubular member extending distal to said distal tip of said core wire, said medical device further comprising at least one piece of radiopaque material inside said first tubular member and distal to said distal tip of said core wire.

46. The medical device ofclaim 43 further comprising a coil extending distal to said first tubular member, said core wire extending distal to said first tubular member inside said coil.

47. The medical device ofclaim 46, said core wire being axially but not torsionally constrained relative to said coil at said distal tip of said core wire.

48. The medical device ofclaim 38, said first tubular member having superelastic properties.

49. The medical device ofclaim 48, said first tubular member having a tip, said tip having reduced superelastic properties.

50. The medical device ofclaim 38 further comprising a second tubular member attached to said medical device.

51. The medical device ofclaim 50 said second tubular member comprising a plurality of slots configured to make said second tubular member more flexible in bending.

52. The medical device ofclaim 38, said first tubular member having chamfer at said proximal end.

53. A medical device configured to navigate through anatomy, the medical device comprising:

a tubular member having a proximal end, a distal end, and a longitudinal axis extending at least from the proximal end to the distal end, the tubular member comprising a plurality of slots configured to make it more flexible in bending;

a core wire disposed at least partially within said tubular member and extending proximal therefrom, said core wire having a distal tip;

a joint attaching said core wire to said tubular member at said proximal end of said tubular member; and

at least one piece of radiopaque material inside said tubular member, at or adjacent to said distal end of said tubular member.

54. The medical device ofclaim 53, at least a plurality of said slots being substantially perpendicular to said axis, said slots being formed in a plurality of groups, at least a plurality of said groups comprising a plurality of slots at substantially the same location along said axis, and wherein in at least some said groups, at least one said slot is substantially deeper than at least one other said slot.

55. The medical device ofclaim 53, said radiopaque material being a helical coil made of wire having a substantially non-circular cross section, said wire having a substantially greater dimension in the radial direction than in the axial direction after being formed into said coil.

56. The medical device ofclaim 53 further comprising a mesial coil proximal to said radiopaque material.

57. The medical device ofclaim 53, said tubular member extending distally from said distal tip of said core wire, said radiopaque material being distal to said distal tip of said core wire.

58. The medical device ofclaim 53, said core wire further being attached to said tubular member at said distal tip of said core wire.

59. The medical device ofclaim 53, said core wire having at least one abrupt change in cross-sectional dimension, said abrupt change being at or adjacent to said joint.

60. A medical device configured to navigate through anatomy, the medical device comprising:

a first tubular member having a proximal end, a distal end, and a longitudinal axis extending at least from the proximal end to the distal end, the first tubular member comprising a plurality of slots configured to make it more flexible in bending;

a second tubular member sharing said longitudinal axis with said first tubular member; and

a core wire sharing said longitudinal axis with said first tubular member and said second tubular member;

said first tubular member being attached to at least one of said second tubular member and said core wire; and

said second tubular member being attached to at least one of said first tubular member and said core wire.

61. The medical device ofclaim 60, said second tubular member being concentric with said first tubular member.

62. The medical device ofclaim 60, said second tubular member being in line with said first tubular member.

63. The medical device ofclaim 60, said second tubular member comprising a plurality of slots configured to make it more flexible in bending.

64. The medical device ofclaim 60 further comprising a first coil concentric with at least one of said first tubular member, said second tubular member, and said core wire.

65. The medical device ofclaim 64, said first coil being inside at least one of said first tubular member and said second tubular member.

66. The medical device ofclaim 64 further comprising a second coil circumscribing at least said core wire.

67. The medical device ofclaim 60, said medical device being configured such that tensioning said core wire causes said distal end of said first tubular member to change in shape.

68. The medical device ofclaim 67, at least some of said slots being deeper on one side of said axis than on the other side of said axis to facilitate said change in shape.

69. A tapered medical device configured to navigate through anatomy, the medical device comprising:

a tubular member having a proximal end, a distal end, and a longitudinal axis extending at least from the proximal end to the distal end, at least a portion of said tubular member comprising a plurality of slots, said slots being configured to make said tubular member more flexible in bending;

a core wire disposed within said tubular member and extending proximal therefrom;

said core wire being attached to said tubular member at least at said proximal end of said tubular member;

said tubular member having a taper at least in its outside diameter over at least a portion of its length, said taper having a decreasing outside diameter in the distal direction, said taper being at least one of continuous and incremental.

70. The medical device ofclaim 69, said tubular member having a continuously tapered outside diameter over at least a portion of said tubular member.

71. The medical device ofclaim 69, said tubular member having an outside diameter that changes in at least one step between said proximal end and said distal end of said tubular member.

72. The medical device ofclaim 69, said tubular member comprising a plurality of sections having different outside diameters, the sections being attached to each other to form said tubular member.

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