JP2001522631A - Method and system for treating obstruction in a body lumen - Google Patents

Abstract

Abstract: A catheter (32), a torque member (52) extending longitudinally through a lumen (50) of the catheter (32), secured to a distal end of the torque member (52). A system is provided having a removal mechanism (54) and a guidewire (46) with a guide portion (200) extending through a lumen of the removal mechanism (54). The guide portion (200) defines a curvilinear profile, which is diametrically larger than the dimensions of the removal mechanism (54). The guide portion (200) of the guidewire (46) is adapted to be positioned inside the occluding material passageway, providing a curved path along and along the inside of the occluding material passageway. , The removal mechanism (54) can be advanced to separate and remove the occluding material. Methods of using this system, and of manufacturing a guidewire (46) and perfusion wire system are also disclosed.

Description

DETAILED DESCRIPTION OF THE INVENTION

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention generally relates to devices and methods for treating and removing occlusive substances from body lumens (eg, blood vessels). In particular, the present invention relates to devices and methods for guided atherectomy.

Description of the Prior Art Numerous methods and devices are currently available for removing stenotic or occlusive materials from blood vessels and for restoring sufficient blood flow to blood vessels. One common procedure is known as percutaneous transluminal angioplasty (PTA), in which a catheter equipped with a dilatation balloon at its distal end is placed in a vessel at the site of a stenosis. . The balloon is used to restore sufficient blood flow to the area beyond the stenosis,
It is then inflated to dilate the blood vessel.

[0003] Although PTA is often effective, it has certain limitations. For example, PT
A can be effective only if the occluding material in the vessel has an opening large enough to allow the balloon to be placed inside the occluding material. When the vessel is almost completely occluded, it is difficult (if not impossible) to place the balloon of the catheter inside the occluding material. In addition, PTA has several intra- and post-procedural problems: sudden closure, elastic bounce, and restenosis. Abrupt closure is a rapid reocclusion of blood vessels within the time of the initial treatment. Abrupt closure can result from rapid thrombus formation, which occurs in response to vascular injury from PTA treatment. Elastic bounce is an elastic recovery in which the dilated blood vessel approaches its pre-treatment diameter. Restenosis is the re-narrowing of blood vessels for weeks or months following an initial apparently successful PTA treatment. Restenosis occurs in all PTs
A occurs in up to 50% of patients and results from smooth muscle cell proliferation and migration and remodeling.

[0004] To overcome these limitations, various catheters and approaches have been proposed that use a removal mechanism to separate and remove occluding material from the lumen wall of the blood vessel. For example, rotational atherectomy devices (eg, San Dieg)
o, California's International Technology
Transluminal Extraction manufactured by Ogis
Boss of Catheter and Bellevue, Washington
Rotablator, manufactured by ton Scientific, relies on a rotational removal mechanism, which can be advanced axially through a nearly completely occluded blood vessel. These mechanisms, however, are only available in certain dimensions (eg, a certain outer diameter). As a result, these removal mechanisms are most effective when used on blood vessels having lumen dimensions close to the dimensions of the removal mechanism. These removal mechanisms are difficult to use with small diameter vessels and are less effective at removing occlusive substances from vessels having lumen dimensions larger than the dimensions of these removal mechanisms. This is a critical limitation since the lumen size, size and range of occluding material, and location of occluding material vary widely for different patients.

[0005] To address this issue, a number of currently available devices (eg, Santa
Guidant Corporation of Clara, California
Simpson Atherocath (R) atherectomy catheter manufactured by U.S.A. and Utzenstorf, Switzerland
Redha-Cut, manufactured by Sherine Med, d., respectively, is equipped with an eccentrically movable removal mechanism or a radially expandable removal mechanism. These removal mechanisms are introduced into the vessel in a collapsed or compressed state inside the sheath or delivery catheter, and then radially inflated or eccentrically displaced (eg, a balloon) at the site of the occluding material. Moved eccentrically by
Separate and remove occluding material. Unfortunately, in areas of stenosis or occlusion of blood vessels, accumulation and formation of occlusive material is rarely consistent, as in some areas more occlusive material can be formed than in other areas. This radial inflatable removal mechanism
Typically, from the beginning to the end, the removal mechanism removes material at approximately the same rate in all radial directions, since it is inflated at the same radial distance, and where there is a large accumulation of occluding material, It may not be effective to remove all of the occluding material. If the procedure is continued until all material has been removed, the removal mechanism may damage blood vessels in locations with low accumulation of occluding material.

[0006] In contrast, this eccentrically movable removal mechanism can remove the asymmetric accumulation of occluding material, but it does not allow its cutting window to move along the length of the stenosis at various discrete locations. Relies on the physician's ability to turn to In addition, they remove substances in an asymmetric manner, so that during their expansion, orientation and use,
If not carefully noted, the directional atherectomy device can damage the luminal wall of the blood vessel (e.g., a formed wire multi-burr Rotati).
onal Ablation Device, U.S. Patent No. 5,584,843, and Abrasive Drive Shaft Device for
Directional Rotation Atheology, US Pat. No. 5,360,432). Therefore, neither the radially inflatable removal mechanism nor the eccentrically movable removal mechanism can be adapted sufficiently effectively to the particular properties of the lumen and the occluding material.

The problems associated with the correct sizing of the device, the nature and size of the occluding material, and the location of the occluding material are further exacerbated when treating the stented area of a restenotic vessel. To address the problems of rapid closure, elastic bounce, and restenosis described above, PTA procedures have been performed following implantation of a vascular stent inside a vessel at the treatment site. These stents are thin-walled scaffolds that are inflated at the treatment site to act as a mechanical support for the luminal wall of the vessel,
Thereby, elastic rebound is prevented. Although this stent reduces the contribution of remodeling to narrowing the vessel, restenosis still frequently occurs at the stent mounting area of the vessel. This is because most stents include an open lattice,
At the cleft between the support elements of the lattice, cell growth, which is often called hyperplasia, can occur. As a result, rather than forming a barrier to hyperplasia and restenosis, the stent can be embedded within a thrombus and accumulated mass of tissue, and the treatment site is restenosis again. The treatment of an occluded stent faces all of the difficulties described above for treating an initial occlusion, and is further complicated by the need to avoid damage to the stent during removal of the hyperplastic occlusive material. Becomes

[0008] Therefore, there is a need for improved methods and devices for treating and removing occlusive substances from blood vessels. In particular, devices and methods that can remove material from nearly completely occluded blood vessels, devices and methods that can treat blood vessels having a range of dimensions, and that can adapt to specific vessel dimensions and lumen shapes during the course of treatment It would be desirable to provide an apparatus and method. Further, the devices and methods of the present invention should be effective for use in removing occlusive material that swallows the implanted stent. Desirably, the devices and methods of the present invention are simple to perform, pose an unacceptable risk to the patient, and are provided by physicians familiar with balloon angioplasty and other conventional endovascular treatments. It is easily implemented. At least some of these objectives will be met by the embodiments of the present invention described below.

SUMMARY OF THE INVENTION A system according to the invention includes a catheter, a torque member, a removal mechanism, and a guidewire, the torque member extending longitudinally through a lumen of the catheter. A removal mechanism is secured to the distal end of the torque member, the guidewire having a guide portion, the guide portion defining a contour, the contour being diametrical and including the removal portion. Larger than the dimensions of the mechanism. The guide portion of the guidewire is adapted to be disposed inside the passage of the occluding material, and provides a curved path along which the removal mechanism causes the passage of the occluding material. Can be advanced inside to separate and remove the occluding material.

In the system of the present invention, the torque member is usually driven to rotate by a driving device (for example, a portable device). The drive contains a motor, which rotates the proximal end of the torque member, thereby rotating the removal mechanism. The removal mechanism can be implemented on any rotary atherectomy device (eg, a rotatable helical cutter, a rotatable modified Forster cutter, a rotatable cutting bar (
(burr), a side cutter having a housing with a rotatable cutting window, or any other similar device that can be used to separate and remove occluding material from the wall of a body lumen). A bearing assembly is typically provided to rotate the torque and removal members while preventing axial movement of the torque and removal members relative to the catheter.

[0011] The system of the present invention may further include a delivery mechanism, which delivers the separated occluding material to a collection reservoir, which is connected to the distal end of the catheter. used. This transport mechanism has a “screw pump” arrangement (eg,
Within the lumen of the catheter, it may be provided in the form of an external coil on the torque member). Alternatively or additionally, the delivery mechanism may include a vacuum source connected to the proximal end of the catheter for drawing material back through the lumen. Alternatively or additionally, the transport mechanism may include a plurality of propellers or vanes.

According to one non-limiting aspect of the present invention, the guide portion of the guidewire is shaped to apply a radial outward force on the lumen wall of the vessel in which it is placed. . In one embodiment, the guide portion of the guidewire has a three-dimensional helical shape, such that the removal mechanism of the lumen wall is occluding material so that the removal mechanism can separate and remove the occluding material. This removal mechanism is juxtaposed with the occluding material in the stenotic portion of the lumen wall so that the septum can be separated and removed. The guide part of this guide wire is
While in the lumen of the torque member, it is substantially straight. The guidewire may include a generally straight proximal portion and a substantially straight distal portion, the proximal portion extending proximally from the guide portion, and the distal portion comprising: Extending distally from the guide portion, the distal and proximal portions of the guidewire extend along the same longitudinal axis.

[0013] The method of the present invention creates a series of diametrically large passages in the occluding material until a desired diameter passage is obtained. The removal mechanism can be advanced over the guide portion of the guidewire to separate and remove the occluding material, creating a curved channel or groove in the occluding material. The removal mechanism can be repeatedly advanced and partially withdrawn from the guidewire with any periodic axial translation of the guidewire guide within the passage of the occluding material. Such removal of a continuous confluent channel of occluding material creates a second passage that is diametrically larger than the initial passage.

If desired, the width or diameter of the guide portion of the guidewire can be increased to enhance this removal. For example, existing guidewires can be replaced with other guidewires that have a diametrically large guide section. Alternatively, the shape memory alloy guidewire may be heated (or cooled) or otherwise energized to cause yet another shape change. The removal mechanism is then advanced over the larger guide portion of the new guidewire to create a third passage that is diametrically larger than the second passage. This process can be repeated to create progressively larger passages until a passage having the desired diameter is obtained.

In certain aspects of the device of the present invention, the device includes a catheter and a guidewire. The catheter includes a catheter body that includes a proximal end,
It has a distal end and a lumen therethrough. At the distal end of the catheter body, a removal mechanism is disposed, which is arranged to excise material from a body lumen and direct the excised material to the lumen of the catheter. The removal mechanism follows a curvilinear path, which usually includes at least one cutting guide, which is advanced by advancing its blade forward into the material and two of the material The material is excised by forming a clear separation between the parts. Such a cutting mechanism does not include an abrasive surface of the type that can be used in other aspects of the invention. The guidewire defines a curved path (especially a helical path), wherein the catheter body advances over the guidewire and deflects the cutting mechanism into such a curved path. be able to. Preferably, such a cutting mechanism has at its distal end no more than 1.2 times the width of the catheter body, preferably with a diameter equal to or less than the distal end. is there. More preferably, the cutting blade includes a helical blade or blade assembly, which is mounted to a distal end of a torque member located within the lumen of the catheter. The helical blade preferably has a diameter at its distal end that is less than or equal to the diameter of the catheter body. An exemplary and preferred helical blade assembly has a pair of blades, which are arranged as a double helix and tapered with a reduced diameter toward its distal end.

In yet another aspect of the device of the present invention, the system includes a catheter and a guidewire, where the guidewire can be the same as described immediately above. The catheter includes a catheter body having a proximal end, a distal end, and a lumen therethrough. At the distal end of the catheter body is disposed a helical blade, the catheter preferably including a torque member, which is located within the lumen of the catheter body. The helical blade preferably has the structure described immediately above.

In yet another aspect of the device of the present invention, an atherectomy catheter includes a catheter body, a torque member, and a helical blade. As used herein, "
The term "atherectomy" refers to the removal of atheroma (hence the name from it), as well as the removal of hyperplastic material following angioplasty and / or stenting. The catheter body has a proximal end, a distal end, and a lumen therethrough. The torque member also has a proximal end, a distal end, and a lumen therethrough, and the torque member is rotatably disposed in the catheter body lumen. An annular lumen is defined between an outer surface of the torque member and an inner surface of the catheter body lumen, and a helical blade assembly is mounted at a distal end of the torque member. The helical blade assembly has at least one helical blade tapered in its distal direction and having an interior open to the annular lumen of the catheter body. In this way, the helical blade can be advanced through the occluding material to excise the material and direct it to an annular lumen for collection and, if necessary, disposal. Preferably, the helical blade assembly includes at least two helical blades, which are arranged as double spirals (ie, parallel to each other). In a still further preferred aspect, a helical screw may be formed in at least one distal portion of the torque member. In this way, as the torque member rotates, the helical screw can act as an "Archimedes" screw pump to facilitate removal of excised material. Typically, the atherectomy catheter further includes a port or other means that, alone or in combination with the helical screw pump, pump vane, or other mechanism, couples the annular lumen. It is in fluid communication with the annular lumen for applying a vacuum to remove ablation material therethrough.

In a particular aspect of the method of the present invention, a region of an occluding material in a body lumen is treated by placing a guidewire having at least one curve within the occluding material region. The curved portion of the guidewire resiliently engages the perimeter of the area within the occluding material, and the cutting blade causes the guide to cut the occluding material from the lumen to enlarge the lumen. Advance over the wire. Preferably, the guidewire is initially advanced into this region in a linear configuration. Thereafter, the straight guidewire is brought or guided in a geometry having at least one curve. For example, the guidewire can be heated to induce a phase transition that causes the guidewire to spiral. Preferably, the guidewire is constrained within a catheter, sheath or other confinement and released at the target site to ensure an unconstrained or partially constrained diameter within the body lumen.
More preferably, advancing the cutting blade comprises rotating the helical blade while advancing axially over the guidewire. The method further includes collecting the ablated material from the internal volume within the helical blade and removing the collected material from the body lumen.

In another particular aspect of the method of the present invention, an area of the occluding material in a body lumen is treated by introducing a guidewire through the area. The guidewire is then heated to induce at least one curve in the guidewire. A removal mechanism (eg, a cutting blade) is then advanced over the guidewire, and the curve engages the removal mechanism against the periphery of the area as the removal mechanism advances. Match or deflect. Typically, this guidewire is a shape memory alloy. Alternatively, the guidewire is a thermal memory alloy, wherein the heating step induces a phase transition from a martensite phase to an austenite phase, wherein the austenite phase has a curved shape. More preferably, the curve is a spiral. Moving the removal mechanism forward
Generally, this involves rotating the cutting blade, and more usually, where the cutting blade is a tapered spiral cutting blade or blade assembly.

[0020] In yet another aspect of the method of the present invention, hyperplastic material may be removed from the interior of the stent in the artery by placing a helical guidewire within the stent attachment area of the artery. The removal mechanism can be any of the mechanisms described above, but is then advanced over the guidewire to create a helical channel in the hyperplastic material. The removal mechanism repeats over the guidewire a sufficient number of times to expose at least a portion of the stent to substantially all of the hyperplastic material in the lumen of the stent. Be advanced. Placing the guidewire includes advancing a linear guidewire to the stent mounting area, and then, for example,
Heating the guidewire to induce a phase transition involves inducing a helical geometry therein. Advancing the removal mechanism typically involves rotating the cutting blade, and more usually, rotating a helical cutting blade having a tapered distal end. This removal step is usually at least twice, preferably at least three times, more preferably at least four times, often at least eight times, to substantially completely remove the hyperplastic material from within the stent. Sometimes it is repeated at least 12 times, about 20 times or more.

A method of manufacturing a wire having a radially expandable guide portion includes the steps of wrapping a core wire around a mandrel; securing the core wire around the mandrel; Heating to a temperature between 800 ° C .; stopping the heating; cooling the mandrel assembly to room temperature; and removing the mandrel from the mandrel.

The process is preferably carried out at an operating temperature between 450 and 550 ° C. If the mandrel assembly is heated in a conventional oven, the incubation time is approximately 5 minutes. The core only needs to be at a temperature sufficient to maintain this shape setting. Increasing the mass of this mandrel or wire may require a long incubation time. A "flash" heating step can be used to facilitate the process, wherein the mandrel assembly is immersed in a molten salt pot or fluidized bath for 1-2 minutes.

In the configuration, it is important that the core is pulled around the mandrel and wrapped around, and that the core does not relax or slip during the configuration. Means are required to secure the mandrel in place, such as a mechanical element (eg, a sleeve) that fits the mandrel with very tight tolerances, to hold the mandrel in place. Or a torque device that keeps the mandrel under tension. Non-mechanical means such as temporary welding, heat resistant adhesives or other means understood by those skilled in the art may be used.

The mandrel is used to shape a core having a radially inflatable guide portion. The mandrel includes a temperature stable nucleus and at least one thread, the thread having spaced thread valleys that can mechanically receive the wire, where the wire is mechanically received. The mandrel has at least one retaining device for securing the core wire in the spaced thread valleys and for preventing the wire from slipping or moving. It is in.

The mandrel generally has a uniform trough diameter between 0.5 mm and 20 mm, but may also have a non-uniform trough diameter. The mandrel also has a linear geometry, which is along its long axis. The linear geometry can be regular and irregular, with a combination of cross member shapes along the linear geometry.

The pitch of the mandrel is between 0.001 inch and 0.5 inch. However, the preferred pitch is between 1 mm and 3 mm. The mandrel can be hollow or solid, but should be a temperature stable material (eg, stainless steel, brass, titanium and ceramic materials, to name a few) for the above-described configuration. In order for the core wire to have an appropriate shape setting, the core wire must be
Must be fixed in place. This includes a screw to lock down to its end, a tube that fits tightly into this mandrel and core wire while keeping all parts in place, non-mechanical means (eg, soldering, gluing or chemical bonding) Can be

The mandrel provides any shape parameters to the mandrel. The diameter of the stem corresponds to the inner diameter of the guide. The outer diameter of the guide is equal to the root diameter of the mandrel plus twice the diameter of the core wire used. If the guide is attached to a conductor, the inner diameter of the guide is determined by subtracting twice the diameter of the coil wire from the trough diameter of the mandrel and calculating the distance between the mandrel and the coil wire (if
This is the value obtained by subtracting twice the value of (if any).

DESCRIPTION OF SPECIFIC EMBODIMENTS The following detailed description is the best currently contemplated mode of carrying out the invention. This description is not to be taken in a limiting sense, but is merely for the purpose of illustrating the general principles of embodiments of the invention. The scope of the invention is best defined by the appended claims. In other instances, detailed descriptions of well-known devices, components, components, mechanisms, and methods are omitted so as not to obscure the description of the present invention with unnecessary detail.

The present invention provides devices and methods for use in treating and removing occlusive substances from blood vessels or other body lumens of animals or humans. The system provides a removal mechanism, which is fixed at the distal end of the torque member. The torque member extends through a catheter, which is used to carry and deliver the removal mechanism to a site of occlusive material inside the blood vessel, where the removal mechanism comprises: Actuated to separate and remove the obstruction member. A guidewire is used to guide the removal mechanism along the location of the occluding material in a controlled manner to separate and remove a portion of the occluding material. In particular, the guidewire is provided with a helical distal guide portion, which guides the removal mechanism along the lumen wall to separate and remove the occluding material. The spiral portion of the guidewire has an unconstrained diameter, which is larger than the outer diameter or dimensions of the removal mechanism. As the removal mechanism passes over the deployed guidewire, a layer of the occluding material is removed, creating a larger diametrically larger path for the occluding material. The helical guide portion of the guidewire is increased in size and / or replaced with a guidewire having a larger helical diameter to remove additional layers of occluding material,
A diametrically larger passage is provided.

As used herein, the term “occlusive material” refers to a proliferative or abnormal tissue or substance that represents an obstacle that occupies the lumen and interferes with the normal functioning of the lumen.
"Occlusion material" can include, but is not limited to, materials such as thrombi, embolic atheroma, smooth muscle cell hyperplasia and other proliferative or abnormal tissues.

As used herein, the term “super-elastic” refers to the property of a substance (usually a metal alloy) that can return to its initial shape upon substantial loading and upon removal of a load. Superelastic alloys can be deformed up to ten times more than ordinary spring materials without being plastically deformed. The superelasticity it shows is extraordinarily large and stress-induced phase transformations (
That is, it is caused by martensite or stress-induced martensite from austenite.

As used herein, the terms “elastic” and “elastic” refer to the property of a material to return to its initial shape after unloading. The elasticity of most materials is limited to plastic deformation that occurs at relatively low strains. Some materials (eg, spring stainless steel) are sufficiently elastic for at least some applications within the scope of the present invention.

As used herein, “shape memory material” refers to a material that has been heated to a specific temperature range and / or higher (ie, As-Af), and then has an initial shape (which is Means a material (usually a metal alloy) that returns to "set" during the fabrication of the material. If a linear piece of austenitic wire is cooled to a temperature within and / or below a specified temperature range (i.e., Ms-Mf) to form martensite, it remains linear. If it deforms by bending the paired martensite, it is converted to deformed martensite. Upon heating, a deformation occurs that returns to austenite, and the wire becomes straight again.

Some materials (eg, certain nickel titanium alloys (eg, Nitinol)
®)) exhibit both superelastic and shape memory properties, and can therefore be used in accordance with more than one aspect of the present invention, as described in more detail below.

FIGS. 1, 1A and 2 illustrate a system 30 according to the present invention. System 30 includes a catheter 32, which has a flexible elongate catheter body 34, which has a proximal end 36 and a distal end 38, and extends longitudinally therethrough. At least one lumen 50 is defined. Catheter 32 is operably connected to a portable device 42 and a collection reservoir 44 via a proximal connector assembly 40. The portable device 42 includes a motor for rotating a removal mechanism 54, which is provided at the distal end 38 of the catheter 32 to remove occluding material, as described in further detail below. And pull out. The collection reservoir 44 collects the occluding material removed from the blood vessel. The guidewire 46 extends through and is used with the catheter 32, as will be described in even more complete detail below.

Referring to FIGS. 2 and 3, the catheter body 34 of the catheter 32 is preferably constructed of a flexible polymer material, which is biocompatible, conformable and lubricious. . Desirable polymer materials can include polyethylene, polyurethane, polyamide, fluoropolymer, and the like. The flexible catheter body 34 is preferably in the form of an elongated tube through which a single lumen 50 extends longitudinally. If desired, the catheter body 34 can be reinforced with multiple braids, spirals, axial filaments, etc., but exemplary embodiments lack such reinforcement. The tube may also be composed of composites and mixtures of more than one polymer material. An elongated torque member 52 having a proximal end 64 extends longitudinally through the lumen 50 of the catheter body 34 (FIG. 7).
), Which is connectable with the portable device 42 to transfer rotational movement from the portable device 42 to a removal mechanism 54, which is secured at its distal end.

(1. Torque Member 52) The torque member 52 is shown in more detail in FIG. The torque member 52 is
Includes three layers of reverse-wound wire, which form a concentric coil. These three coil layers include an inner coil 56, an intermediate coil 58 and an outer coil 60, all of which are fixed together. In the embodiment illustrated in FIG.
The inner coil 56 is wound in a helical direction, counterclockwise, which is opposite to the clockwise helical winding direction of the intermediate coil 58. Inner coil 56 defines a hollow guidewire lumen 62. Internal coil 56 and intermediate coil 58
Work together to transmit torque. The proximal end 64 of the intermediate coil 58 is rotatably connected to the portable device 42, as shown in FIG. 7 and described in further detail below. As the intermediate coil 58 is rotated clockwise, it tends to decrease in diameter, due to its clockwise winding direction. At the same time, the counter-wound inner coil 56 again tends to be diametrically larger due to its counterclockwise winding direction. This creates a rotational mesh between the inner and intermediate coils 56, 58, which locks the coils 56 and 58 together, creating a reliable torque transmitting member. This engagement between the inner and intermediate coils 56, 58 provides a torque transmitting member, which
It exhibits excellent torsional stiffness while leaving sufficient flexibility to navigate tortuous paths in the patient's vasculature.

[0038] The inner and intermediate coils 56 and 58 are arranged in a filamentous arrangement.
ings). FIG. 4 illustrates a quadrafilar coil configuration (ie, four wires wound together) for the inner and intermediate coils 56 and 58, but depending on the requirements of the application. hand,
A threaded arrangement of any number of wires wound together can also be selected. In this regard, the determination of the number of wires in a threaded arrangement is based on balancing three basic requirements. The first requirement concerns the inherent flexibility associated with a given number of wires in a group. Generally, if a small number of wires are provided in each thread group,
A highly flexible torque member 52 is obtained. The second requirement relates to the total number of desired windings along the length of the torque member 52. For example, to produce a quadruple, in contrast to a single thread torque member 52 of the same length, fewer turns are required (which means less production time). A third requirement relates to energy conservation when twisted. With less wire in one arrangement, more rotational energy is stored along the length of the torque member. In other words, "entangling" (
There is a phenomenon called "whipping" (when viewed from the input side) or "whipping" (as viewed from the output side), which requires more rotation at the proximal end before its distal end begins to follow . In general, when designing a torque member, it is desirable that its output (ie, distal rotational performance) closely follows the input (ie, proximal rotational performance). The more wires in one deployment, the less torsional preload required before the distal end follows the proximal end.

The inner and intermediate coils 56 and 58 may have the same or different helix angles and spacing. The helical angle used for the inner and intermediate coils 56 and 58 can range from approximately 5 degrees to 85 degrees relative to its longitudinal axis, with the torque requirements of the application and the torturous torque of the patient's vasculature. You can choose based on your requirements. The spacing between the coils 56 and 58 can range from zero to the width of the thread-like arrangement, and can be selected based on the requirements of this application. Internal and intermediate coils 56 and 5
The helix angle and spacing for 8 is also related to and contributes to the "entanglement" phenomenon. For example, if the helix angle is steep, it is easier to obtain a tighter thread-like arrangement. Additional requirements also exist. For example, a steep helix angle requires more wire, requires more winding, and achieves a more flexible torque member 52. Conversely, a shallow helix angle only requires the use of less wire and requires less winding. In order to obtain a shallow angle, the "filament ribbon" is not laid flat, but "twisted"
As required, the shallow helix angle also occupies more radial space in a given torque member 52.

The outer coil 60 does not rely on contributing to this torque transmission, but rather removes the occluding material separated and removed from the removal mechanism 54 into the lumen 5 of the catheter 32.
0, and finally as part of the transport mechanism 54 for transport outside the patient's body to the collection reservoir 44. Transporting the separated and removed occlusive material outside the patient's body is referred to hereinafter as "withdrawal." The outer coil 60 and inner surface 66 of the lumen 50 together form a carrier. In order to function effectively, the diameter of the lumen 50 is selected so that the inner surface 66 is in close proximity to the outermost surface of the outer coil 60. The outer coil 60 is wound on the intermediate coil 58 in a winding direction opposite to the winding direction of the intermediate coil 58. The outer coil 60 is wound in substantially the same direction, and can be wound even in the same angular range as the inner coil 56. The outer coil 60 is spaced to form a helical groove 68 having a spacing 69 between adjacent windings on the outer coil 60. The spacing 69 is uniform in length throughout, through which the helical ring (through which fluids (eg, saline, blood, Ringer's solution, etc.) and excised occluding material pass, in an unlimited manner, Can be selected). In particular, the spacing 69 is selected such that the dimensions of the largest tissue fragment separated and removed move unhindered through the helical groove 68. When the outer coil 60 and inner surface 66 of the catheter lumen 50 are arranged and arranged, an Archimedes-type “spring pump”
Is produced. The use of this "screw pump" arrangement can eliminate the need for external suction, but to supplement and enhance the tissue extraction function of this "screw pump", an externally connected suction device (depicted below) Can be used.

The winding directions of the inner, middle and outer coils 56, 58, 60 are shown as rotating clockwise. If a counterclockwise rotation of the torque member 52 is desired, the winding directions for the inner, intermediate and outer coils 56, 58, 60 are:
Should be reversed.

The inner, intermediate and outer coils 56, 58, 60 can be formed from a suitable wire material (eg, stainless steel and other metals that are biocompatible and torsion resistant).
Further, these coils 56, 58 and 60 may have a circular or ribbon-like cross section. FIG. 4B shows an improved configuration in which the wire 60 is replaced by a series of spaced vanes 61 to pump liquid inside the lumen 50. The blades 61 are fixedly mounted on the torque member 52 and are defined such that when the torque member 52 is rotatably engaged, fluid is pumped out of the body. By creating a cell (where the wire 60 is moved a predetermined length and separated by a blade 61 as a cell separator), the wire 60
And the blades 61 can be used in combination. The cell has a blade 61
It is defined by the distance 63 between them.

It may be beneficial to include the three layers of coils 56, 58, 60 in a polymer jacket 70 (see FIG. 4A), which serves to secure the coils 56, 58, 60 together. Polymer jacket 70 can be applied using one of a number of approaches. For example, the polymer jacket 70 can take the form of a thermoplastic sleeve, which melts around the coils 56, 58, 60 to fill their crevices, and between the guidewire lumen 62 and the delivery device. Then, a barrier defined by the outer coil 60 and the inner surface 66 is produced. Alternatively, polymer jacket 7
0 may be a thermoplastic or thermoset sleeve with shape memory properties (eg, cross-linked polyolefin, polyester, fluoropolymer, etc.), which are shrunk onto the triple coil 56, 58, 60 assembly. As yet another alternative, the polymer jacket 70 can be a thermoset (eg, a polyimide);
This is applied by dipping, casting, spraying, brushing or other similar methods. In applications where the torque member 52 must have small dimensions and contours, other thin thermoplastic jackets (eg, parylene) can be vacuum deposited on the torque member 52 and used as the polymer jacket 70.

The outer coil 60 need not be provided as a separate wire. For example, using any of the methods and polymer materials described above, the internal and intermediate coils 56
, 58, and the outer coil 60 can then be formed by selectively removing the polymeric material to form a helically shaped outer coil 60. This selective removal of the polymeric material can be achieved by using any known method (eg, external threading on a lathe).

(2. Removal Mechanism 54 and Bearing Assembly 100) The removal mechanism 54 is fixed to the distal end 72 of the torque member 52. The removal mechanism 54 is used to ablate occlusive material from the lumen wall of a blood vessel or other body lumen. Excision can be achieved by cutting, shearing, coring, scraping or other known methods. The function of the removal mechanism 54 is to remove the occluding material from the lumen wall of the blood vessel, so that the occluding material can then be removed and withdrawn from the patient's vasculature.

One embodiment of the removal mechanism 54 is illustrated in FIGS. 2 and 3 is a rotatable helical cutter. The helical cutter 54 has a plurality of counterclockwise helical turns 74, which define a longitudinally extending lumen therethrough and have a longitudinally extending side along it. Shear. The helical turn 74 has a proximal cutting end 76, which is adapted to cut occluding material during clockwise rotation of the helical cutter 54. In other words, the proximal cutting edge 7
6 is effectively its leading end as the cutter 54 rotates clockwise. The number of helical turns 74 depends on the desired cut smoothness and "aggression" to remove tissue. In this regard, “aggression” is defined as the degree of engagement between the removal mechanism 54 and the occluding material. For example, increasing the number of spiral turns 74 over the same axial length while reducing the number of spiral turns 74 results in a more aggressive cut. If the spiral cutter 54 rotates counterclockwise, the spiral turn 74 should be spiral in the opposite direction (ie, clockwise in this case).

The helical cutter 54 is secured to the distal end 72 of the torque member 52 as follows. Referring to FIGS. 3-4, the length of the distal portions of the intermediate and outer coils 58 and 60 are skinned or trimmed to an outer peripheral point 82 to expose the distal length 84 of the inner coil 56. This is illustrated in FIGS. 3 and 4,
In this case, the middle and outer coils 58 and 60 are moved from their proximal ends to the outer periphery 8.
2 is shown extending to the most distal extension defined by 2. The distal-most ends 86 and 88 of the intermediate and outer coils 58 and 60, respectively, are then attached and subsequently fixed (eg, by welding, soldering, brazing or gluing) to form the intermediate and outer coils 58 And 60 are prevented from unraveling. The spiral cutter 54 then has an internal coil 56
Slides over the exposed distal length 84 of the inner coil 56 so as to be received inside the lumen of the spiral cutter 54, and the proximal end 90 of the helical cutter 54 is brazed, soldered, welded, glued Or by any other conventional method at the distal ends 86 and 88 of the intermediate and outer coils 58 and 60, respectively. The distal end 92 of the helical cutter 54 is also secured to the outer surface of the inner coil 56 at a position slightly proximal to the distal tip 94 of the inner coil 56 using one of the methods described above. It is also possible to secure the inner surface of the helical turn 74 along the outer surface of the inner coil 56. The helical groove 96 defined between the helical turns 74 communicates with the helical groove 68 of the outer coil 60 to deliver the removed or cut occlusion material to the carrier defined by the outer coil 60 and the inner surface 66. I do.

The torque member 52 is disposed inside the lumen 50 of the catheter 32 and extends longitudinally therethrough, and most of the exposed distal length 84 of the inner coil 56 is
Extending distally and outwardly of the distal end 38 of the catheter 32. Accordingly, the helical cutter 54 also partially extends outside the catheter body 34. At a fixed axial position at the distal end 38 of the catheter body 34, the distal end 72 of the torque member 52 is rotated while simultaneously rotating the torque member 52 and the removal mechanism 54.
A bearing assembly 100 is provided for securing the removal mechanism 54 secured thereto.

Referring now to FIGS. 2 and 5-6, the bearing assembly 100 includes:
Includes a resilient snap ring 102 and an overlying shell 104.
The snap ring 102 is best illustrated in FIGS. 3 and 5 and has a cylindrical body 106, around an inner surface 110 of the cylindrical body 106, an internal rib 108.
Is growing. One longitudinal slit 112 can be provided along the cylindrical body 106 so that the ring 102 can compress or radially expand. The rib 108 includes an outer circumferential groove 114 provided near the proximal end 90 of the spiral cutter 54.
Adapted to fit inside. The snap ring 102 is preferably
Manufactured from stainless steel or other resilient alloys, and preferably are biocompatible and provide good resistance to fatigue resulting from elastic or plastic deformation.

The shell 104 is best illustrated in FIGS. 3 and 6, and has a generally cylindrical body 120, which has an annular distal lip 122, which extends radially inward. Thus, the distal opening 124 of the cylindrical main body 120 is narrowed. Ramp 126
Extends from the proximal end of the cylindrical body 120 and slopes radially inward to form a cylindrical barbed portion 128, which has a smaller diameter than the diameter of the cylindrical body 120. Have. The plurality of barbs 130 are formed on the outer surface 132 of the cylindrical barbed portion 128.
It is provided in. Shell 104 is preferably manufactured from stainless steel or other resilient alloy and is preferably biocompatible.

To assemble the bearing assembly 100, the snap ring 102 is first secured to the proximal end 90 of the helical cutter 54, and before the snap ring 102 fits inside the shell 104, the shell 104 is Secured to the distal end 38 of the catheter 32.

Specifically, the torque member 52 and the proximal end 90 of the helical cutter 54
First, the outer peripheral rib 108 is slid into the lumen of the cylindrical body 106 of the snap ring 102 until it is fitted or installed inside the outer peripheral groove 114. Slit 112
The elasticity of the cylindrical body 106 obtained by means of the above allows the body 106 to extend and the proximal end 90 of the helical cutter 54 to pass over the rib 108 therebetween until the groove 114 receives the rib 108 Becomes possible.

At the same time, the barbed portion 128 of the shell 104 is attached to the distal end 3 of the catheter body 34.
At 8, slide inside the lumen 50. The barbs 130 engage the inner surface 66 of the catheter body 34 to form a secure barb-hose type connection. The distal tip of the catheter body 34 is such that it acts as a ramp 126 (which acts as a stop that limits the distal advancement of the catheter body 34 along the barbed portion 128).
Can be slid over the outer surface 132 of the barbed portion 128 until further,
The outer surface 134 of the cylindrical body 120 of the shell 104 is preferably aligned with the outer surface 136 of the catheter body 34 to provide a smooth transition between the shell 104 and the catheter 32.

At this point, the distal lip 122 of the shell 104 has slipped over the snap ring 102. The distal opening 124 of the cylindrical body 120 has a smaller diameter in its normal relaxed state than the diameter of the cylindrical body 106 of the snap ring 102,
The cylindrical body 106 needs to be radially compressed so that the distal lip 122 can pass over it. The longitudinal slits 112 provide resiliency so that the cylindrical body 106 can be radially compressed without bending its structure. Once the distal tip 122 passes over the entire cylindrical body 106 of the snap ring 102, the resiliency of the snap ring 102 causes the cylindrical body 106 to bounce back to its normal relaxed state, in which state , It is mounted inside the shell 104 between the distal lip 122 and the ramp 126 to create a secure interference fit.

Alternatively, bearing assembly 100 may first be provided in the manner described above with shell 104.
Can be assembled by sliding the snap ring 102 inside the. The shell 104 is then secured to the distal end 38 of the catheter 32 and the helical cutter 54 is secured to the snap ring 102 using the method described above.

The bearing assembly 100 performs two functions. First, the distal lip 1
22 and ramp 126 are both connected to snap ring 102 inside shell 104.
Thrust bearing for a thrust bearing consisting of Second, the interaction between snap ring 102 (which is securely connected to helical cutter 54 and inner coil 56) and shell 104 (which is securely connected to catheter body 34). The action provides a smooth rolling bearing surface. In this manner, the interference fit of snap ring 102 inside shell 104 between distal lip 122 and ramp 126 causes misalignment of helical cutter 54 and inner coil 56 with respect to catheter body 34. While preventing ribs 108 and groove 114
And the spiral engagement between the spiral cutter 54 and the internal coil 56. The interface and interaction between the shell 104 and the snap ring 102 can prevent the catheter body 34 from rotating when the torque member 52 and the helical cutter 54 are rotated.

(3. Proximal connector assembly 40, portable device 42 and collection reservoir 44
Referring now to FIGS. 1 and 7, the proximal connector assembly 40 of the system 30 has an elongated rigid body 150 defining a front and a back. The front 152 of the rigid body is rigidly connected to the proximal end 36 of the catheter body 34.
The proximal end of front portion 152 is connected to the distal end of rear portion 154 of rigid body 150. Through a front portion 152 and a back portion 154, a lumen or passage 156 extends longitudinally, which includes a rotor shaft 158 provided inside the portable device 42.
The inner hollow lumen is in communication. Torque member 52 extends through passage 156 and is secured inside the lumen of rotor shaft 158. The rigid body of the proximal connector assembly 40 has a side arm 160, which is connected to the collection reservoir 44 via a tube 162. The rear 154 is provided with a dynamic seal 164 that prevents fluid flow through the passage 156 and into the portable device 42 and also allows all occluding materials and fluids (eg, blood) Arm 1
60 and the torque reservoir 5 to ensure that it is deflected into the collection reservoir 44.
Acts as a seal around 4. The dynamic seal 164 can be implemented in the form of an O-ring or a perforated gasket of an elastomeric material (either a synthetic material (eg, silicone) or a naturally occurring material (eg, natural rubber)). To connect the proximal connector assembly 40 to the front 165 of the portable device 42, a rear 154
A normal male-male luer fitting 163 is also provided.

The portable device 42 has a housing 166, which houses a motor 168 and a battery 170. The battery 170 is connected to the motor 16 via a lead 172.
8 to supply electrical energy. Control switch 174 is connected to motor 168 and battery 170 by similar leads 175 and 176, respectively, to control operation of motor 168. The motor 168 is connected to the shaft 1
78, which carries a first drive gear 180, which rotatably meshes with the second gear 182 and rotatably drives the second gear 182. The second gear 182 is carried on the rotor shaft 158 such that the rotation of the first drive gear 180 causes the second gear 182 to rotate the rotor shaft 158, thereby displacing the torque member 52 held thereon. Rotate. A first plurality of rotor shaft bearings 184 are provided to facilitate rotation of the rotor shaft 158, and a second plurality of gear bearings 186 facilitate rotation of gears 180 and 182. It is provided in order to make. The proximal end of the guidewire 46 is carried from the proximal end 64 of the torque member 52 inside the portable device 42 through an opening 188 (which is provided at the proximal end of the housing 166). Extends out of the mold device 42,
This allows the surgeon to perform a guidewire change and manipulate the guidewire 46, as described in more detail below.

The collection reservoir 44 is a ceramic or polymer container, which is transparent so that the surgeon can visually confirm the full capacity of the reservoir 44. The first conventional male-male luer fitting 167 collects the tube 162 into the collection reservoir 44.
Connect to The delivery mechanism defined by the outer coil 60 and inner surface 66 of the lumen 50 transports the occluding material from the distal end 38 of the catheter 34 to the rear 154 of the proximal connector assembly 40, where the occluding material is placed. The material is a dynamic seal 1
Due to the action of the "screw pump" 64, it is deflected to the collecting reservoir 44.

A “screw pump” defined by the outer coil 60 and inner surface 66 of the catheter lumen 50 treats the occluding material, even though it may be sufficient to completely remove any occluding material separated from the blood vessel. It is also possible to apply suction to the vascular region. This allows the collection reservoir 44 to have a second normal male-female fitting 19.
0 (this is connected to the vacuum pump 192 via the pump tube 194). Such suction enhances the removal of the excised occlusive material.

4. Guidewire 46 The catheter 32 is preferably designed to operate in an over-the-wire fashion. Catheter 32 can be used with a conventional guidewire to form an initial pilot lumen of the same size as the outer diameter of catheter 32 and removal mechanism 54. The normal guidewire can then be replaced with the guidewire 46 of the present invention.

FIG. 8 illustrates one embodiment of a guidewire 46 that can be used with the system 30 of the present invention. Guidewire 46 is preferably used to separate and remove occluding material so that a series of conduits shaped through the occluded vessel lumen can be created.
A shape is provided to guide the removal mechanism 54 in a controlled manner along and along the location of the occluding material. The passage created through this occlusion is diametrically larger than the outer diameter of removal mechanism 54 and catheter 32.

Referring to FIGS. 8, 8A and 8C, guidewire 46 is generally provided with a helical distal guide portion 200 adjacent its distal end 202. As shown in FIG. 8A, the helical distal guide portion 200 has a three-dimensional shape that approximates the shape of a lumen wall. The distal end 202 of the guidewire 46 is generally straight and preferably has an atraumatic distal tip 206. The rest of guidewire 46 (particularly proximal portion 204) is generally straight, similar to a normal guidewire. Distal part 2
02 and the proximal portion 204 are axially coplanar with each other, and are preferably coaxial with respect to each other. In other words, the distal portion 202 and the proximal portion 20
4 are oriented along the same vertical axis. Further, distal portion 202 and proximal portion 204 are concentric with guide portion 200 and may be eccentric. The proximal and distal tips of guide portion 200, or the entire helical portion, are preferably
The guide portion 200 is sufficiently radiopaque to be clearly visible during fluoroscopy. This radiopacity can be provided by use of a radiopaque wire 201, as shown in FIG. 8C, which can be manufactured from a platinum or gold alloy or other radiopaque wire and Wound around 199 to form a spiral turn of the guide portion 200.

The guide wire 46 conforms to the catheter 32 carried thereon and the removal mechanism 54 to follow the helical shape of the helical guide portion 200 to bring the removal mechanism 54 into contact with the inner lumen wall of the blood vessel to be treated. Is intended. Continuously passing the catheter 32 and removal mechanism 54 along the helical guide portion 200, the guidewire 46
After a continuous axial translation, a passageway is formed in the lumen of the blood vessel, generally the diameter of the helical guidewire 200 and the diameter of the occluding material removed by the removal mechanism 54. Equal to the sum of twice the depth of the cut, shear or slice.

The nucleus 199 of the guide wire 46 (in particular its guide portion 200) is preferably
It is formed using materials of composition, processing regimen, shape and dimensions that operate over a range within the elastic limits of the material. Specifically, the material used for the guide portion 200 is preferably the lower boundary of the yield stress and the material (especially a sufficiently wide range of deformation (eg, up to about 8%) that full recovery can still be achieved. ) Operates within the range defined by the upper boundary of the elastic limit of). As used herein, "yield stress" means the stress level at which finite strain is first observable. "Stress" can be defined as an applied force or force system that tends to distort or deform an object. "Strain" can be defined as deformation caused by stress. As used herein, "elastic limit" means the level of stress at which permanent deformation, ie, plastic deformation, occurs.

Therefore, the guide portion 200 with the material operating within the yield stress and elastic limits of the material is substantially free from the internal open space of a substantially tubular or duct-like passage (especially from a true cylindrical shape to a substantially cylindrical shape). Has a pre-formed shape applicable to non-cylindrical lumen spaces. Such a guide portion 200 can be elastically deformed (rather than plastic) to pass it through the guidewire lumen 62 of the torque member 52 and its entirety inside the stenosis or lumen passage. The shape can be recovered.

As a result, the pitch (ie, wavelength) and helical diameter HD (ie, amplitude) of the helical guide portion 200 preferably move due to the stenosis or the changing geometry of the passage in the body lumen. Can be adapted. For example, the pitch: diameter ratio preferably ranges from 0.1: 1 to 5: 1, and in one embodiment is 1: 1. The pitch of the helical portion and the helical diameter HD are preferably varied as the volume of the occluding material decreases. Specifically, when the volume of the occluding material is greatest (i.e., when the passage through the occluding material is smallest), this pitch opens and the helical diameter HD decreases. As the volume of occluding material decreases, the pitch preferably plugs and the helical diameter HD increases.

Further, the maximum diameter HD of the helix of the helical guide portion 200 is preferably selected such that it is equal to or slightly larger than the body lumen being deployed for treatment. However, as explained below, depending on the type of operation used,
The diameter can be changed. The helical angle of the helical guide portion 200 also depends on the removal mechanism 5.
As 4 traverses guide portion 200, the rigid length of removal mechanism 54 is selected such that it has a minimal effect on elastically deforming the helical turns of helical guide portion 200. The overall length HL of the spiral guide portion 200 is preferably selected to be slightly longer than the length of the occluding material traversing.

An example of a material that can be used for the guide portion 200 is nickel-titanium (NiTi).
There is a shape memory alloy such as NiTi exhibits superelasticity and is more flexible than normal stainless steel, thereby facilitating insertion of the spiral guide portion 200 through the guidewire lumen 62. NiTi allows for more accurate axial positioning adjacent to the previously removed helical conduit by more easily conforming to the body lumen to be treated.

Examples of superelastic metal alloys (including NiTi), which can be used to form the core 199 of the guidewire 46 of the present invention, are described in detail in US Pat. No. 4,665,906. ing. U.S. Pat. No. 4,665,906 discloses the composition, properties, chemistry and behavior of certain metal alloys that are superelastic within the temperature range at which the guide portion 200 of the guidewire 46 of the present invention operates. As noted, as used herein, some and all of the superelastic metal alloy may be used to form a core 199 of the guide portion 200 of the guidewire 46. obtain.

When using NiTi to form the core 199 of the guide portion 200 of the guidewire 200, the helical guide portion 200 of the guidewire 46 is provided in its initial helical shape having its maximum helical diameter. . The guidewire 46 is then mechanically deformed into a substantially straight configuration so that it can be easily inserted through the guidewire lumen 62. After inserting the guidewire 46 into the vessel to be used according to the method described below, the helical guide portion 200 is returned to its initial helical shape, at either its maximum helical diameter or the varying helical diameter. Depending on the mode of operation used, this may be by thermally guiding the helical guide portion 200 back to its helical shape (either its maximum diameter or a varying helical diameter), or in this substantially linear form. This can be achieved by releasing the force holding the spiral guide portion 200.

A helical guide 200 having at least a core made of NiTi can be used in the following manner: superelasticity, restraint recovery without proportional control, and restraint recovery with proportional control. These terms are now defined here.

The term “superelastic” refers to the property of an alloy to return to its initial shape when unloaded after substantial deformation. Superelastic alloys, such as NiTi,
It can be distorted ten times more than normal spring materials. Regarding the guide wire 46,
The "super-elastic" mode is a NiTi core spiral guide portion 200 that has an initial helical shape, deforms when held in a substantially straight shape, and is released from the holding force in a substantially straight shape. It means the part that returns to the initial spiral shape.

“Constrained recovery” refers to a NiTi core helical guide portion 200 having a maximum diameter equal to or greater than the diameter of the lumen passage, where it returns to its initial helical shape at its maximum helical diameter. When expanded). Again, this lumen route
It may be a passage created through the occluding material. In other words, the spiral guide part 2
00 is "trapped" in that it contacts this lumen passage as it "recovers" its initial helical shape.

“Proportional control” means that the helical guide portion 200 is guided to advance progressively over this continuum from its linear shape to its maximum total helical diameter. This means that the initial spiral shape of the spiral guide portion 200 is proportionally controlled.

Proportional control can be achieved by titrating the amount of thermal energy applied to the spiral guide section 200. For example, heat can be applied to the spiral guide portion 200 by dipping the spiral guide portion 200 in a physiologically inert fluid (eg, saline, Ringer's solution, etc.), which fluid It is introduced via a guiding catheter (not shown) through which the catheter 32 is introduced. Alternatively, heat can be applied to the helical guide portion 200 by passing an electrical current through the guidewire 46 to its proximal end 204. This can be achieved by attaching one or two leads to the spiral guide portion 200. For example, referring to FIG. 8B, the lead pair 203 is connected to a heat source (eg, a resistance heater RH). Lead pair 203 has a distal lead attachment 205 and a proximal lead attachment 207, which are provided at the distal and proximal tips of spiral guide portion 200, respectively.

In addition, during energy titration, a temperature sensor (eg, a thermocouple or thermistor) is provided integral with or near the helical guide portion 200 for closed loop feedback to an appropriate electrical circuit. be able to. One possible arrangement may include a distal temperature sensor 208 and a proximal temperature sensor 209 located at the distal and proximal tips of the helical guide portion 200, respectively (see FIG. 8B).
Each temperature sensor can be either a thermocouple or a thermistor. The distal temperature sensor 208 can be connected to a first thermocouple or thermistor temperature sensing circuit via a first lead pair 211, and the proximal temperature sensor 209 can be connected to a second lead pair 213 via a second lead pair 213. The thermocouple is connected to a thermocouple or thermistor temperature detection circuit. Temperature sensing element 20
8, 209 measure the temperature gradient over the helix of the spiral guide section 200. This temperature sensing placement method utilizes the space available within a 0.014 inch or other normal size guidewire diameter, and the measured temperature accurately matches the spiral guide portion 20.
This corresponds to a phase conversion correlation with a helical diameter of 0. Proportional control is achieved with the necessary guidewire 46 for this method, as will become more apparent in the description of the method of the invention below.
Reduce the number of.

Any of the NiTi wires used as the guidewire core 199 (ie, superelastic, restraint recovery without proportional control, and restraint recovery with proportional control)
Are commercially available, for example, from Raychem Corp. of Menlo Park, California. Can be obtained from

The helical guide portion 200 of the guidewire 46 can be modified to generally have a tapered or stepped shape, or both a tapered and stepped shape. For example, the helical guide portion 200 can be tapered from its proximal tip to the distal tip such that its helical diameter decreases from its proximal tip to its distal tip. The helix can also be stepped at some discrete location of the guide portion 200. Further, while the spiral guide portion 200 of the guidewire 46 is shown as a spiral of uniform shape, it is possible for the spirals to be provided in a manner that is non-uniform to one another over the spiral length HL. .

As yet another alternative, the guide portion 200 need not be provided in a spiral shape.
Referring to FIG. 8D, the guide portion 200a has a polygonal shape in a three-dimensional space.

As yet another alternative, a plurality of guide portions 200 may be provided at the distal end of guidewire 46 in a spaced apart manner. For example, having two spaced guide portions 200 may be beneficial in treating a restenotic body lumen at the location of a spaced implanted stent.

The curved three-dimensional contour has a longitudinal dimension and a radial dimension, which can be increased in inverse proportion to the radial dimension. The curvilinear three-dimensional contour has 0.02 lbf (0.0045 N) and 2.0 lbf (0
. 45N) when applied a tensile force (measured by an Instron type tensile strength test facility) such that its radial dimension approaches the same diameter as the proximal end of the guidewire. Can extend in any direction. The pulling force is typically generated by a catheter advanced over the guide portion. The guide portion can be repeatedly expanded and contracted to a plurality of radial dimensions. These expansions and contractions can be generated by mechanical, thermal or elastic energy.

The test methodology for this tensile test includes: first, a wire with a radially expandable guide is pulled through a 0.016 inch inside diameter glass tube. . When the radially inflatable guide is fully extended in the glass tube, the distance between the start and end of the radially inflatable guide is measured. The wire is then marked at those points (generally by pulling the wire slightly or by cutting the glass tube at the points to be marked). The wire is then withdrawn from the glass tube and relaxed back to a curved three-dimensional profile. The distance between these relaxation points is then measured. This wire is then
Attached to an Instron type tensile strength tester with a zero pound load cell,
The clamp for this Instron tensile strength test is then mounted at the point previously marked on the wire. The jaws are spaced at the same length as the relaxation distance between these marked points, and the pulling distance is the measured distance of the wire (which is This is a distance obtained by subtracting this relaxation distance). The wire is then withdrawn slowly (about 2.54 cm / min) and the force required to pull the wire close to the extension of the glass tube is measured. Currently, this test represents a preferred embodiment of measuring the force applied to the wire during operation. Care must be taken to avoid orthogonal alignment problems that can skew these results.

4. Mandrel for Use in Manufacturing Guide Wire 46 FIG. 8E illustrates a mandrel for manufacturing the guide portion 200 of the present invention. FIG. 8E shows a mandrel 8 having a channel 8004 for receiving the guidewire 46.
000. Mandrel 8000 has a proximal receptacle 8012 for receiving guidewire 46 and means for securing guidewire 46 to mandrel 8000. The distal portion of guidewire 46 is formed by threading through receptacle 8012. FIG. 8F shows a guidewire 46 wrapped around a mandrel 8000, the distal and proximal ends of which are receptacles 8008 and 8
Through 012, it is suitably threaded. FIG. 8G illustrates a full mandrel assembly 80.
50, 300 ° C. and 800 ° C. to thermally cure the guide wire 46.
Heated between ° C. The guidewire 46 is secured by a device (eg, screw 8016) for locking the wire in place. Guide wire 46
Any locking means is provided to prevent the grease from sliding down during this temperature curing stage. FIG. 8H shows the final shape of the guidewire 200 after this shape setting. The period 8055 between the smaller dimensions on the mandrel is due to the spiral winding 805
Note that it matches the distance between 5 '.

5. Alternative Removal Mechanisms In FIGS. 9A-9D, a number of alternative removal mechanisms 54 are illustrated. FIG. 9A shows that the spiral cutter 54a has a shallow spiral angle while the spiral cutter 54a has a shallow spiral angle.
Has a steep helical angle, except that the helical cutter 54 shown in FIGS.
Is similar to As a result, the helical cutter 54a has fewer helical turns 74a. The helical turn 74a also has a proximal cut end 76a, which cuts the occluding material during the counterclockwise rotation of the helical cutter 54a.
Adapted. If the spiral cutter 54a rotates counterclockwise, the spiral turn 74a needs to be wound in the opposite direction. The helical cutter 54a is secured to the exposed distal length 84 of the inner coil 56 according to the same method described above. A bearing assembly (eg, the bearing assembly 100 described above) is also preferably provided at the connection between the catheter body 34 and the helical cutter 54a.

FIG. 9B illustrates a Forstner cutter 230, which can be used to core a passage through the occluding material. The Forstner cutter 230 is
Defined by a cylindrical shaft 232, which is provided at its distal end with a wide annular coring blade or cut end 234. The plurality of scraping surfaces 236 are spaced about 180 degrees apart to crush the occluding material cored by the coring blade 234. The cutter 230 slides the distal end 72 of the inner coil 56 through the hollow lumen of the cylindrical shaft 232 and the proximal end 238 of the cylindrical shaft 232 to the middle and outer coils 58 and 6, respectively.
The connection to the inner coil 56 of the torque member 52 by being secured to the zero distal ends 86 and 88. A helical turn 240 is provided at the proximal end 238 of the cylindrical shaft 232 to facilitate transport of occluding material from the cutter 230 to the delivery device defined by the outer coil 60 and the inner surface 66 of the catheter body 34. . The cutter 230 is housed inside a cutter housing 242, which includes a proximal cylindrical portion 246 (on which the cutter 230 is housed).
And in the form of a tapered cylinder having a tapered distal portion 248. The proximal end of the proximal cylindrical portion 246 may be connected to the catheter body 3 by an adhesive bond, barb-hose connection 247 (see FIG. 9B), or other similar fastening means.
The distal cylindrical portion 246, which is fixedly attached to the distal end 38 of the 4, or can be integral with the catheter body 34. A side window 250 is provided between the proximal cylindrical portion 246 and the tapered distal portion 248, through which a portion of the annular coring blade 234 extends to cut the occluding material. are doing.
The cutter housing 242 does not rotate with the cutter 230. In use, the cutter 230 is rotated so that the removed occluding material is received through the side window 250 and the helical turns 240 of the cylindrical shaft 232 and the external It is conveyed through a spiral groove defined by the spiral turns of the coil 60. A bearing assembly 251 is also preferably provided at the interface between the distal end 72 of the torque member 52 and the distal tapered portion 248 of the cutter housing 242.

FIG. 9C illustrates a rotary cutter 260 that can be used to remove small amounts of occluding material. The rotary cutter 260 has a cylindrical shaft 262 with a spherical rotary bar 264 at its distal end. The bar 264 has a plurality of peripheral helical groove blades 26 on the surface of the bar 264 to remove the occluding material.
6 are provided. The cutter 260 slides the distal end 72 of the inner coil 56 through the hollow lumen of the cylindrical shaft 262 and the proximal end 268 of the cylindrical shaft 262 to the middle and outer coils 58 and 60, respectively.
Connected to the inner coil 56 of the torque member 52 by securing to the distal ends 86 and 88 of the torque member 52. Cutter 260 is provided through and through the outer peripheral side window 276 of the two-part cutter housing. The cutter housing includes a proximal cylindrical portion 272 (which is secured to the distal end 38 of the catheter body 34 by a barb-hose connection, an adhesive bond or other similar securing means), And a tapered distal portion 274, which is secured to the distal end 72 of the torque member 52 by welding, soldering or other similar securing means.
In use, the distal tapered portion 274 rotates with the bar 264 so that the removed occluding material is aspirated by use of a "screw pump" or because only a small amount of occluding material is removed and removed. Can escape through the patient's bloodstream, or either. A bearing assembly (eg, bearing assembly 100 described above) is also preferably provided with catheter body 34 and rotary cutter 2.
It is provided at a connection portion between the two. In the embodiment illustrated in FIG. 9C, the proximal cylindrical portion 272 may actually be part of the shell 104 of the bearing assembly 100.

FIG. 9D illustrates a side cutter 290, which can be used to remove occluding material. A side cutter 290 is provided in the form of a distal housing 292 at the distal end 72 of the torque member 52. The distal housing 292 has a tapered cylindrical body that is secured to the distal end 72 of the torque member 52 by welding, soldering, or other similar securing means. Distal housing 2
One side of the distal end 300 of the 92 is provided with a side window 298. Side window 2
98 defines a tapered incision 302 and a lateral incision 304. In use, the distal housing 292 rotates with the torque member 52 but with the cut end 302
And 304 operate to remove the occluding material. This occluding material is received through the side window 298 and transported along the helical groove defined by the helical turns of the outer coil 60. The bearing assembly is similar to the bearing assembly 100 described above, but also includes a proximal cylindrical portion 2 of the catheter body 34.
At the interface between 94 and distal portion 38, it can be provided.

During use of the cutters 260 and 290, the cutters 260 and 290
, And their housings 274 and 292 are rotated with the torque member 52 to remove the occluding material. However, during rotation of cutter 230, housing 242 is not rotated.

6. First Method of Use FIGS. 10A-10M illustrate one method of using the system 30 of the present invention, which includes some alternatives and variations.

FIG. 10A shows a segment of a blood vessel BV, which is partially occluded by the occluding substance OM in the area where the stent S has been previously implanted. Occlusion substance O
Between M, a small occlusion passage OP is defined, which has a significantly smaller diameter than the annular passage LP of the blood vessel BV. 10A-10M illustrate the use of system 30 at a connection with a vessel BV partially occluded by occluding material OM at the area where stent S has been previously implanted, but system 30 also includes It can be used in unattached blood vessels BV that have been partially occluded (ie, stenotic) by the occluding material OM. The system 30 can also be used with fully occluded blood vessels if an initial pilot guidewire (eg, guidewire GW described below) can be passed through this occlusion.

(A. First Step—Introduction of Guidewire) In the first step illustrated in FIG. 10B, a linear guidewire GW is percutaneously introduced into the lumen passage LP using a conventional guidewire introduction method. And the closed passage OP
Through the occluding material OM. As part of the normal guidewire introduction method,
A guide catheter (not shown) is first introduced through the puncture wound into the patient's vasculature, and the guidewire GW and catheter 32 are introduced continuously through the lumen of the guide catheter. Guidewire GW may be a regular stainless steel guidewire. Alternatively, the guidewire GW may be a NiTi guidewire 46 according to the present invention, which has been mechanically deformed from its initial helical shape to a substantially linear shape, and has been heated to restore its initial helical shape. Guidance is required (ie, does not include a NiTi guidewire operating in a superelastic configuration). At this point, the physician uses conventional angiography to calculate the positional and dimensional characteristics of the occluded segment of the vessel BV. If the stent S is implanted adjacent to an occluded segment of the blood vessel BV, the length and deployment diameter of the stent S are also calculated.

(B. Second Stage—Formation of Initial Pilot Lumen) After the guidewire GW is placed inside and extends through the occlusion passage OP, the catheter 32 is placed inside the lumen passage LP with a “wire” On "(ovre-the-wi
re) In a manner, advanced along the guidewire GW to the proximal extension of the occluding material OM. See FIG. 10C. As the portable device 42 is actuated and the removal mechanism 54 is rotated, as it advances through the occluding material OM, in the path of the removal mechanism 54, a portion of the occluding material OM is separated, removed and withdrawn. Is rotated. As the catheter 32 is advanced distally over the guidewire GW, the catheter body 34
Is not rotated during the rotation of the removal mechanism 54, but as such, the guide wire GW (
It is itself "centered" on the occluding material OM (having a substantially linear shape). When the removal mechanism 54 reaches the distal extension of the occluding material OM, an initial pilot lumen PL is formed, as shown in FIG. 10D. The pilot lumen PL has a diameter substantially equal to or outer diameter of the removing mechanism 54.

(C. Third Step—Removal of Guide Wire GW) Once the initial pilot lumen PL has been formed in the occluding material OM, the axial position of the catheter 32 is maintained at the distal extension of the occluding material OM, Then, the guide wire GM is removed. See FIG. 10E. The removal of the guide wire GM at this stage is as follows.
If the guide wire GM is a NiTi guide wire 46 according to the present invention (which
It can be omitted if it is mechanically deformed from its initial helical shape to a substantially linear shape and requires heat induction to recover to its initial helical shape).

D. Fourth Stage—Introduction of Guidewire 46 Guidewire 46 according to the present invention is now selected by the physician. Guidewire 46 may be a superelastic guidewire or a restrained recovery NiTi guidewire. The maximum helical diameter of the helical guide portion 200 can be selected to be equal to or greater than the diameter of the pilot lumen PL. The guidewire 46 may also be configured such that the length HL of the helical guide portion 200 is greater than the length of the occluding material OM and the implanted stent S.
It is chosen to be equal to or greater than the length (if applicable). Further, the helical guide portion 200 is such that the resistance encountered during advancing the helical guide portion 200 through the guidewire lumen 62 in the inner coil 56 of the torque member 52 does not interfere with subsequent front loading operations. Then, the initial spiral shape is deformed to a substantially linear shape. This deformation is achieved by elastically deforming the spiral guide portion 200, rather than plastically deforming it. If the guidewire is a superelastic guidewire, this deformation is achieved by forward loading guidewire 46 through guidewire lumen 62. If the guidewire 46 is a constrained restoration TiTi guidewire, this deformation can be, for example, applying sufficient tension to the spiral guide portion 200 and the user's thumb and forefinger (which is the spiral guide portion 200). By simultaneously applying a compressive force to straighten) and pulling it through a dowel die. In other words, twinned martensite, which is similar in shape to the parent austenite (ie, helical shape), is converted to deformed martensite, which is substantially linear.

The selected guidewire 46 is then forward loaded into the proximal end 40 of the catheter 32 and advanced until the straight distal end 202 exits the distal end 72 of the torque member 52. . See FIG. 10F. This forward loading step is also performed if the guide wire GM is mechanically deformed from a NiTi guide wire 46 according to the present invention (from its initial spiral shape to a substantially straight shape) to its initial spiral shape. (Requires thermal induction to recover)). During this forward loading phase, the spiral guide portion 200 is substantially straightened inside the guidewire lumen, as shown in FIG. 10F. The spiral guide portion 200 is provided with the torque member 5.
2, the pitch is not generally linear, but is more pitch inside the torque member 52 than when deployed for use inside the blood vessel BV while placed outside the torque member 52. Open significantly and its diameter becomes significantly smaller.

E. Fifth Step—Retraction of Catheter 32 The catheter 32 is now withdrawn until its distal end 38 is the distal extension of the occluding material OM. At this point, if guidewire 46 is a superelastic guidewire, helical guide portion 200 will naturally assume its maximum helical shape as constrained by the lumen wall of pilot lumen PL. If the guidewire 46 is a constrained recovered NiTi guidewire, the spiral guide portion 200
Is then heated above the austenite final temperature Af to return to its helical shape and diameter as constrained by the pilot lumen PL.
This heating involves immersing the helical guide portion 200 in a physiologically inert fluid (eg, saline, Ringer's solution, etc.) introduced via the lumen of the guide catheter, according to one of the methods described above. Or by passing an electrical current through the guidewire 46 from its proximal end 204.

In any case, the helical guide portion 200 now exhibits a helical diameter defined by the diameter of the pilot lumen PL, where the helical turn of the helical guide portion 200 is Adjacent to or contacted. Therefore, as shown in FIG. 10G, the helical guide portion 200 can be configured to position the helical turn adjacent to or in contact with the occluding material OM, thereby reducing the diameter of the pilot lumen PL and the nature of the occluding material ( For example, shape).

(F. Sixth Step—First Passing of Removal Mechanism 54) The distal end 38 of the catheter 32 and the removal mechanism 54 are now advanced over the helical guide portion 200. The removal mechanism 54 is rotated during advancement of the catheter 32, while maintaining the guidewire 46 at the same axial position in the lumen passage LP.
The helical guide portion 200 guides the removal mechanism 54 along a spiral path where the removal mechanism 54 engages the occluding substance OM. Referring to FIG. 10H, with the ability of the helical guide portion 200 to match the dimensions and properties of the pilot lumen PL and the occluding material OM, the removal mechanism 54 is positioned alongside the lumen wall of the pilot lumen PL. Will be maintained. Thus, the removal mechanism 54 is held off-axis with respect to the pilot lumen PL and at any given axial position within a single wavelength along the helical guide portion 200,
The removal mechanism 54 is not co-planar with any preceding or next axial position along the helical guide portion 200. Further, the pitch of the spiral guide section 200 is open and the spiral guide section 200 is relatively small, as the diameter of the pilot lumen PL is relatively small, as compared to the subsequent lumen to be created, constraining the guidewire GM. Has a smaller diameter.

The removal mechanism 54 follows the spiral path of the spiral guide section 200 as it is guided along it. However, a portion of the spiral guide portion 200 proximal to the removal mechanism 54 is straightened, as best illustrated in FIG. 10H.
When the distal end 38 of the catheter 32 reaches the most distal extension of the occluding material OM, the helical channel HC of the occluding material OM is removed. See FIG. 10I.

(G. Seventh Step—Retracting Removal Mechanism 54 to Translate Guide Wire 46 Axially) At this point, the catheter 32 and its removal mechanism 54 have a distal end 38 Until OM is proximal, guidewire 46 is passed through lumen passage L
Retracted proximally while maintaining the same axial position at P. At this point, the helical guide portion 200 again reverts itself to the existing lumen (which has now cut one helical channel into the occluding material OM) and the size and nature of the occluding material. Match.

The guidewire 46 then retracts or advances it by a distance close to the width of the helical channel HC, which is equal to the axial length of the shearing or cutting side of the removal mechanism 54 of the proximal incision 76. By doing so, it is rearranged. Again, the helical guide portion 200 conforms itself to the dimensions and properties of the existing lumen and occluding material with respect to its new axial position inside this lumen. See FIG. 10J.

(H. Eighth Stage—Removal Mechanism 54 for Creating Larger Blocked Passage OP)
The removal mechanism 54 is now again rotatably advanced over the helical guide portion 200 according to the manner described in the sixth step above, and the other helical channels HC (
This cuts off the previously removed spiral channel HC). FIG. 10K
See. The seventh and eighth stages are continuous until all of the removed helical channels HC have coalesced to create a larger passage OP (its diameter is approximately the same as the maximum helical diameter of the helical guide portion 200). Is repeated.

(I. Ninth Stage-Creating One or More Larger Occluded Paths OP) If necessary, one or more progressively larger occluded paths can be created. is there. If the existing guidewire 46 is a superelastic guidewire or a constrained NiTi guidewire (without proportional control), the existing guidewire 4
6 is another guide wire 46 having a spiral guide portion 200 of a larger diameter.
Can be exchanged for The larger diameter helical guide portion 200 of the new guidewire 46 is itself capable of providing the dimensions and properties of the existing lumen OP, which now has a larger diameter than the pilot lumen PL, and the occluding material OM. Matches. Again, due to the performance of the spiral guide portion 200 where the spiral guide portion 200 matches the dimensions and properties of the obstruction passage OP and the obstruction material OM, the removal mechanism 54 causes the obstruction passage OP
Is placed and maintained in juxtaposition with the lumen wall. The above third to eighth steps can be repeated to create a larger closed passage OP. See FIG. 10L.

The next guide wire 46 having a larger diameter spiral guide portion 200 can be replaced, and the third to eighth steps are repeated until it is confirmed that a sufficiently large treatment passage TP has been created. , Can be repeated to create an increasingly larger occluded passage OP. See FIG. 10M. As part of this confirmation, the physician considers obtaining the relative position and diameter of the implanted stent S (if applicable), as well as the treatment passage TP, which is approximately equal in size to the lumen passage LP. This procedure is now here,
The procedure can be terminated by withdrawing the catheter 32, the guide wire 46 and the guide catheter.

In carrying out this method step, the system 30 of the invention and the described method are suitable for protecting the integrity of any stent S that can be implanted in the treatment area of a blood vessel BV. This is due, in part, to the fact that the guidewire 46 can be selected with a helical guide portion 200 that matches the inside diameter of the stent S to avoid cutting or damaging the stent S.

The ability of the helical guide portion 200 to match the dimensions and properties of the lumen passage LP and the occluding material OM allows the removal mechanism 54 to be used safely with occluding materials OM having inconsistent properties. For example, the force or stress applied by the helical guide portion 200 to the lumen wall can be reduced at the most constrained cross section (ie, the smallest diameter passage).
Will be the largest. In the area immediately adjacent to this constrained cross-section (or the area having a larger volume of occluding material OM), the removal mechanism 54 is directed more strongly in the outward direction (by the helical guide portion 200), thus obstructing the obstruction. The material OM is cut further deeply. This deeper cut causes a portion of this cross-section to "catch up" (or catch) other less constrained portions (or regions with smaller volumes of occluding material OM).
up), generally creating new lumens that gradually take on a more regular, annularly symmetrical shape. As this lumen is enlarged by subsequent passage of the removal mechanism 54,
A progressively smaller force is applied to the lumen wall by the spiral guide portion 200.

7. Second Use The use illustrated in connection with FIGS. 10A-10M can be improved if guidewire 46 is a restraint-recovery NiTi guidewire with proportional control.

According to this improved method, in a first stage the initially introduced guidewire GW is a restraint-recovery NiTi guidewire with proportional control, which is the method disclosed in connection with the fourth stage above. Accordingly, the shape is changed from the initial spiral shape to the substantially linear shape. As a result, the third and fourth steps are omitted. In the fifth stage, the heat applied to the spiral guide portion 200 causes the spiral guide portion 200 to have a spiral shape (but
(Not the maximum helical diameter). Finally, in the ninth stage, instead of replacing the existing guidewire 46 with another guidewire 46 having progressively larger helical sections 200, the heat applied to the helical guide sections 200 is replaced by a helical guide. The portion 200 is titrated so as to gradually reacquire its maximum helical shape (ie, in a stepwise manner). Therefore, this procedure involves a guide wire 46
Is required.

Thus, the present invention provides systems 30 and methods that are effective in separating, removing and withdrawing occluding materials from body lumens. The helical guide portion 200 of the guidewire 46 allows the removal mechanism 54 to create a passageway in the occluding material OM, which is diametrically larger than the dimensions of the removal mechanism 54. The provision of the guidewire 46 and its spiral guide 200 also allows the physician to optimize the size (or diameter) of the spiral guide to avoid damaging the vessel lumen wall or damaging the implanted stent. You will be able to choose 200 carefully. This ability to select the size of the created lumen passage allows the system 30 and method of the present invention to be used in a wide range of applications, patients and ailments. The system 30 and method of the present invention are also simple to use.

Although the guidewire 46 and its guide portion 200 of the present invention are described for use with a removal mechanism, the guidewire 46 and its guide portion 20 are described.
0 for other uses (eg, diagnostics (eg, intravascular ultrasound imaging, vascular microscopy, fluoroscopy), energy delivery (eg, laser, cryogenic, radiation, photodynamic therapy, brachytherapy, Ultrasound angioplasty), amputation (eg, directional coronary atherectomy catheter, transluminal extraction catheter), resection (eg, rotational atherectomy catheter), thrombectomy, selective biopsy, and (With, but not limited to, drug delivery), it is also possible to use with catheters or probes. In this regard, the guide portion 200 may be associated with associated devices when used, for example, in vascular microscopy, ultrasound imaging, and arterial monitoring in critically ill patients applications (eg, blood pressure and flow measurements, and oximetry). On the other hand, effective stability can be provided.

The present invention provides a kit for performing the method of the present invention, as illustrated in FIG. These kits include a catheter 300 having a cutting tip 302,
Includes the guidewire 304 and instructions 306 describing how to use the catheter in combination with the guidewire. These kit parts are usually packaged together in a regular package 310 (eg, a sachet, box, tube, tray, etc .; this is typically sterile). The instructions 306 may be in the form of a package insert (as shown), or may be wholly or partially printed on the package 310 itself.

While the description above refers to particular embodiments of the present invention, it will be understood that many modifications may be made without departing from the spirit thereof. The appended claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention.

[Brief description of the drawings]

FIG. 1 illustrates a system according to the invention.

FIG. 1A is a detailed view of a distal end of a catheter and a guidewire of the system of FIG. 1;

FIG. 2 is an enlarged cutaway view of a distal end of a catheter and a removal mechanism that can be used in the system of FIG.

FIG. 3 is a cross-sectional view of the distal end of the catheter of FIG. 2 and a removal mechanism.

FIG. 4 is a partial cutaway side view of a torque member that can be used with the system of FIG.

FIG. 4A is a partial side view of the torque member of FIG. 4, illustrating the torque member encased in a polymer jacket.

FIG. 4B is a partial side view of an alternative torque member shape that can be used with the system of FIG.

FIG. 5 is a perspective view of a snap ring of a bearing assembly that can be used with the system of FIG. 1;

FIG. 6 is a perspective view of a shell of a bearing assembly that can be used with the system of FIG. 1 and with the snap ring of FIG. 5;

FIG. 7 is an enlarged cross-sectional view of a proximal connector assembly, a portable unit, and a collection reservoir that can be used with the system of FIG.

FIG. 8 is a side view of the distal end of a guidewire that can be used with the system of FIG.

FIG. 8A is a cross-sectional view of the distal end of the guidewire of FIG.

FIG. 8B is a view showing a state in which the guide portion of the guide wire is expanded by proportional control;
FIG. 3 is a side view of a part of the spiral portion of the guide wire of FIG.

FIG. 8C is an exploded side view of a portion of the guidewire of FIG.

FIG. 8D is a cross-sectional view of the distal end of another guidewire based on the guidewire principle of FIG. 8;

FIG. 8E shows a mandrel used to manufacture a guidewire having a guide portion.

FIG. 8F illustrates a mandrel used to manufacture a guidewire having a guide portion.

FIG. 8G shows a mandrel used to manufacture a guidewire having a guide portion.

FIG. 8H illustrates a mandrel used to manufacture a guidewire having a guide portion.

FIG. 9A illustrates a different embodiment of a removal mechanism that can be used with the system of FIG.

FIG. 9B illustrates a different embodiment of a removal mechanism that can be used with the system of FIG.

FIG. 9C illustrates a different embodiment of a removal mechanism that can be used with the system of FIG.

FIG. 9D illustrates a different embodiment of a removal mechanism that can be used with the system of FIG.

FIG. 10A illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 10B illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 10C illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 10D illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 10E illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 10F illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 10G illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 10H illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 10I illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 10J illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 10K illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 10L illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 10M illustrates one method of using the system of FIG. 1 to treat and remove occlusive material from a blood vessel.

FIG. 11 illustrates a kit according to the invention.

──────────────────────────────────────────────────続 き Continued on the front page (31) Priority claim number 60/081, 631 (32) Priority date April 13, 1998 (April 13, 1998) (33) Priority claim country United States (US) ( 81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE), CA, JP (72) Inventors Williams, Ronald G. United States 94025, Menlo Park, Campo Vero Lane 149 (72) Inventors Kupiki, David Jay. United States California 94114, San Francisco, Market Street 3276 (72) Inventor Patterson, Greg Earl. United States California 94566, Pleasanton, Malaga Court 1020 (72) Inventor Mar, Kathy M. United States California 94041, Mountain View, West Dana Street 1077 Bee F Term (Reference) 4C060 EE21 FF21 MM25

Claims (117)

[Claims] 1. A guidewire for use in guiding another device to a desired location within a body lumen, the guidewire comprising: a substantially linear proximal portion and a guide portion, the guide portion comprising: , Defining a curved three-dimensional contour, the contour being diametrically larger than the diameter of the proximal portion,
The guide portion provides a curved path along which another device can be advanced, the guide portion is made of a shape memory material, and the shape memory material is A substantially straight proximal portion and a guide portion that are flexible enough to assume a substantially straight shape when extended through a lumen of a guide member associated with another device or catheter. , Guidewire. 2. The guide portion is made of a material that remains in its resilient or super-elastic state when the guide portion extends through a lumen of a guide member associated with the another device or catheter. The guidewire according to claim 1. 3. The method further comprises a substantially linear distal portion extending distally from the guide portion, wherein the linear proximal portion extends proximally from the guide portion. And wherein the proximal and distal portions of the guidewire are
3. The guidewire of claim 1 or 2, wherein the guidewire extends along the same longitudinal axis. 4. All of the preceding claims, wherein the guide portion is inflatable or can be shaped to apply a radial outward force on the lumen wall of the lumen in which it is located. The guidewire according to the section. 5. The guidewire according to claim 1, wherein the guide portion is inflatable to a diameter between 0.5 and 20 mm with a preferred operating diameter between 1 and 6 mm. 6. All of the preceding claims, wherein the guide portion has either a helical or polygonal shape to provide a helical or polygonal path for a catheter tracking thereon. A guidewire according to claim 1. 7. The guidewire has a taper, increasing in diameter at its proximal end and decreasing in diameter at its distal end, wherein the taper is any along the length of the guidewire. Either progressive and continuous from one point to the distal end, or multiple steps to the distal end starting at any one point along the length of the guidewire The guidewire of any of the preceding claims, wherein 8. The guide portion has a nucleus made of a superelastic material having a tensile strength of at least X, and the nucleus is between 0.002 inches and 0.01 inches in diameter. A guidewire according to any of the preceding claims. 9. The guidewire of any preceding claim, wherein the guide portion has a nucleus made primarily of a nickel-titanium material or a superelastic material. 10. The guiding portion of the guide wire includes a lead accessory for delivering heat to the guiding portion, and means for measuring a temperature gradient across the guiding portion, such as a thermistor or thermocouple. A guidewire according to any of the preceding claims, provided. 11. The method according to claim 1, wherein the guide portion has a tapered spiral shape or a generally uniform spiral, or has a step between adjacent spirals, or has a stepped shape. The described guidewire. 12. The outward radial force of the guide portion includes: increasing the core diameter of the guide portion; increasing the unconstrained radial diameter of the guide portion; The guidewire of any of the preceding claims, which can be increased by any combination of reducing the spacing or adjusting the alloying composition of the shape memory material used in the guide portion. 13. The shape memory material of the guiding portion has a transition temperature of greater than 10 ° C. and is present in the austenite phase of the shape memory material when the guiding portion is at zero percent (0%) induced strain. A guidewire according to any of the preceding claims. 14. A system, comprising: a catheter having a distal end, a proximal end, and a lumen extending longitudinally therethrough; a torque member; A torque member extending longitudinally through the lumen of the catheter and having a lumen and a distal end; a removal mechanism secured to the distal end of the torque member; Removal mechanism;
And a first guidewire. 15. The method according to claim 15, further comprising a second guidewire, the second guidewire defining a curved three-dimensional contour, the contour being diametrical and a guiding portion of the first guidewire. 15. The system of claim 14, wherein the system is larger than the dimension of the system. 16. The torque member includes a PTFE three-layer composite material wrapped by a wire braid below a polyimide layer, the three-layer composite material being fixed on the inner coil and the inner coil. 15. The system of claim 14, wherein the system is wrapped by an intermediate coil and an external coil fixed over the intermediate coil. 17. The internal coil, the intermediate coil and the external coil all have a helical shape, the internal coil has a helical winding direction different from a helical winding direction of the intermediate coil, and The outer coil has a helical winding direction different from the helical winding direction of the intermediate coil, and the inner coil has a helical winding direction substantially opposite to the helical winding direction of the intermediate coil, When the torque member is rotated in one direction, the intermediate coil attempts to decrease in diameter, and the inner coil attempts to increase in diameter, whereby the 2. A rotational engagement between the intermediate coil and the internal coil.
7. The system according to 6. 18. The system of claim 16, wherein said torque member has a distal end, and wherein said removal mechanism is secured to said distal end of said torque member. 19. The catheter of claim 1, wherein the lumen has a lumen wall, wherein the lumen wall and the outer coil define a delivery mechanism for withdrawing separated occluding material, Forming a plurality of helical grooves, wherein the helical grooves operate as a screw pump to remove the occluding material. 20. The method of claim 20, further comprising a collection reservoir connected to the proximal end of the catheter and receiving the occluding material withdrawn by the delivery mechanism. 20. The system of claim 19, wherein the system is in communication with the lumen or a suction pump can be coupled to the collection reservoir to aspirate occluding material. 21. A portable device comprising a portable device having a lumen connected to the proximal end of the catheter and communicating with the lumen of the catheter. 15. The torque device of claim 14, wherein a torque member extends longitudinally through the lumen of the portable device, the portable device further comprising a motor for rotating the torque member. System. 22. The removal mechanism includes at least one helical turn wrapped around the torque member, the helical turn having a leading cutting end, and connecting the distal end of the catheter. 15. The system of claim 14, wherein the system extends beyond. 23. The removal mechanism includes a cylindrical shaft having a distal end and a lumen, the torque member being received inside the lumen of the shaft, the removal mechanism including a wide annular cutting. An end and a plurality of scraping surfaces, wherein the wide annular cutting end is provided at a distal end of the shaft, and wherein the scraping surface is provided with the annular cutting end for crushing the resected occlusion material. 15. The system of claim 14, wherein said system is in communication. 24. The removal mechanism is housed inside a housing, the housing having a proximal end and a cutting window, wherein the proximal end is secured to a distal end of the catheter. 24. The system of claim 23, wherein through the cutting window, a portion of the annular cutting tip extends to cut occluding material. 25. The removal mechanism includes a cylindrical shaft having a distal end and a lumen, wherein the torque member is received inside the lumen of the shaft, and wherein the removal mechanism includes 2. The device according to claim 1, further comprising a rotating bar provided at the distal end.
5. The system according to 4. 26. The removal mechanism includes a cutter housing, wherein the torque member is housed inside the cutter housing, and the distal end of the torque member is secured to the housing. The system of claim 14, wherein the cutter housing has a side window defining at least one cutting edge. 27. The apparatus of claim 27, further comprising a bearing assembly for coupling the removal mechanism to the distal end of the catheter, the bearing assembly coupled to the distal end of the catheter and the removal mechanism. Allowing rotation of the removal mechanism and preventing axial translation of the removal mechanism relative to the catheter;
The system according to claim 14. 28. The bearing assembly has a shell member and a snap ring, the shell member being connected to the distal end of the catheter, and the snap ring allowing rotation of the removal mechanism. Wherein the snap ring is fitted inside the shell member to prevent axial translation of the snap ring and the removal mechanism. 28. The system of claim 27. 29. The shell member having a cylindrical body and a proximal ramp,
The cylindrical body having a radially inwardly extending annular distal lip and the proximal ramp sloping radially inward to form a cylindrical barbed portion; 29. The system of claim 28, wherein the portion has a diameter smaller than the diameter of the cylindrical body. 30. The snap ring has a cylindrical body and a rib, the cylindrical body has an inner surface, and the rib extends circumferentially around the inner surface; 30. The system of claim 29, wherein the snap ring further includes a longitudinal slit, the slit being provided along the cylindrical body so as to compress and radially expand the cylindrical body. . 31. The removal mechanism has an outer circumferential groove, wherein the rib is
31. The system of claim 30, wherein the system fits inside the peripheral groove. 32. The system of claim 28, wherein the snap ring rests inside a shell between the distal lip and the ramp. 33. The guide portion of the guide wire comprises a lead accessory for delivering heat to the guide portion, and either a thermistor or a thermocouple for measuring a temperature gradient across the guide portion. The system of claim 14, wherein 34. A system, comprising: a catheter having a distal end, a proximal end, and a lumen extending longitudinally therethrough; a torque member, A torque member extending longitudinally through the lumen of the catheter and having a distal end; a removal mechanism secured to the distal end of the torque member; A first guidewire having a guide portion, the guide portion extending through a lumen of the removal mechanism and defining a curvilinear contour, wherein the contour is , Diametrically,
A first guidewire, larger than the dimensions of the removal mechanism, wherein the guide portion provides a curved path along which the removal mechanism can advance; and a second guidewire; The second guidewire can be used in place of the first guidewire, the second guidewire having a guide portion, the guide portion extending through a lumen of the removal mechanism, and A contour that is diametrically greater than the dimension of the guide portion of the first guidewire, the guide portion of the second guidewire providing a curved path; A second guidewire, wherein the removal mechanism can be advanced along a curved path. 35. Each of the guide portions of the first and second guidewires is configured to apply a radial outward force on a lumen wall of a lumen in which the guidewire is disposed. 35. The system of claim 34. 36. The system of claim 35, wherein each of the guide portions of the first and second guidewires has a helical shape to provide a helical path to the removal mechanism. 37. A method of treating an area of an occluding substance in a body lumen, comprising: a. Introducing a guidewire into the body lumen, through the area of the occluding material; b. Introducing a catheter over the guidewire, the catheter having a removal mechanism disposed at a distal end thereof; c. Creating an initial pilot lumen through the occluding material; d. Retracting the catheter and the removal mechanism to a position proximal to the occluding material and along the guidewire; e. Providing a guide portion within the guide wire, the guide portion comprising:
Having a curvilinear profile, the profile being diametrically larger than the dimension of the removal mechanism; f. Advancing the removal mechanism along the guide portion to separate occluding material and leave a curved channel therein; g. Retracting the catheter and the removal mechanism to a position proximal to the occluding material and along the guidewire; h. Axially translating the guide portion of the guidewire within the occluding material; and i. Advancing the removal mechanism along the guide portion to separate and remove the second curvilinear channel in the occluding material, wherein the second curvilinear channel comprises the first curving channel in the occluding material. Joining the curved channel. 38. The method further comprising: j. Retracting the catheter and the removal mechanism to a position proximal to the occluding material and along the guidewire; k. Axially translating the guide portion of the guidewire within the occluding material; l. Advancing the removal mechanism along the guide portion to separate and remove the third curvilinear channel in the occluding material, wherein the third curvilinear channel comprises the first and the second in the occluding material. Merging with a second curved channel; and m. 38. The method of claim 37, comprising repeating steps (j)-(l) until all confluent channels in the occluding material are removed and a new large diameter lumen passage is created. 39. The method further comprising: j. Retracting the catheter and the removal mechanism to a position proximal to the occluding material and along the guidewire; k. Increasing the size of the guide portion of the guidewire; and l. Advancing the removal mechanism along the guide portion to separate and remove the third curvilinear channel in the occluding material, the third curvilinear channel comprising the first curving channel in the occluding material. 38. The method of claim 37, comprising: having a larger diameter than the curved channel. 40. The method of claim 39, wherein step (k) comprises applying heat to the guide portion of the guidewire. 41. The method further comprising: j. Advancing the catheter and the removal mechanism to a position distal from the occluding material and along the guidewire; k. Replacing the guidewire with a second guidewire, the second guidewire having a guide portion that is larger in size than the guide portion of the removed guidewire; l. Retracting the catheter and the removal mechanism from the occluding material to a position proximal to and along the guidewire; and m. Advancing the removal mechanism along the guide portion of the second guidewire to separate and remove the third curved channel in the occluding material, wherein the third curved channel comprises 38. The method of claim 37, comprising: having a larger diameter than the first curved channel in a substance. 42. The method of claim 37, wherein step (e) comprises providing a helical shape to the guide portion. 43. Step (e) further comprises: in the form of a nickel-titanium alloy;
43. The method of claim 42, comprising providing the guide portion of the guidewire. 44. The method of claim 37, wherein step (e) further comprises causing the guide portion to exert a radial outward force on the pilot lumen. 45. Step (e) further comprises providing the guide portion from a shape memory material, wherein the shape memory material, when the guide portion extends through a lumen of the torque member, 4. A material having sufficient flexibility to exhibit a substantially linear shape.
7. The method according to 7. 46. The method of claim 37, wherein step (e) further comprises providing the guide portion from a material that remains in its resilient state as the guide portion extends through the lumen of the torque member. The method described in. 47. A method of treating an area of an occluding substance in a body lumen, comprising: a. Introducing a first guidewire into the body lumen, through the area of the occluding material; b. Introducing a catheter over the first guidewire, the catheter having a removal mechanism disposed at a distal end thereof; c. Creating an initial pilot lumen through the occluding material; d. Removing the first guidewire; e. Introducing a second guidewire through the lumen of the catheter, the second guidewire having a guide portion, the guide portion having a curvilinear profile;
The profile is diametrically larger than the dimensions of the removal mechanism; f. Retracting the catheter and the removal mechanism to a position proximal to the occluding material and along the second guidewire; g. Advancing the removal mechanism along the guide portion to separate and remove the first curved channel in the occluding material; h. Retracting the catheter and the removal mechanism to a position proximal to the occluding material and along the second guidewire; i. Axially translating the guide portion of the second guidewire within the occluding material; and j. Advancing the removal mechanism along the guide portion to separate and remove the second curvilinear channel in the occluding material, wherein the second curvilinear channel comprises the first curving channel in the occluding material. Joining the curved channel. 48. The method further comprising: k. Axially translating the guide portion of the second guidewire within the occluding material; and l. Advancing the removal mechanism along the guide portion to separate and remove the third curvilinear channel in the occluding material, wherein the third curvilinear channel comprises the first and the second curving channels in the occluding material. 48. The method of claim 47, comprising: joining the second curved channel. 49. The method further comprising: k. Retracting the catheter and the removal mechanism to a position proximal to the occluding material and along the second guidewire; l. Increasing the size of the guide portion of the second guidewire; and m. Advancing the removal mechanism along the guide portion to separate and remove the third curvilinear channel in the occluding material, the third curvilinear channel comprising the first curving channel in the occluding material. 48. The method of claim 47, comprising: having a larger diameter than the curved channel. 50. The method of claim 49, wherein step (l) comprises applying heat to said guide portion of said second guidewire. 51. The method further comprising: k. Retracting the catheter and the removal mechanism to a position proximal to the occluding material and along the second guidewire; l. Exchanging the second guidewire for a third guidewire, the third guidewire having a guide portion that is larger in size than the guide portion of the second guidewire; and m. Advancing the removal mechanism along the guide portion of the third guidewire to separate and remove the third curvilinear channel of the occluding material, wherein the third curvilinear channel comprises the occluding material. 48. The method of claim 47, comprising: having a larger diameter than the first curvilinear channel of. 52. The method of claim 47, wherein step (e) comprises providing a spiral shape to said guide portion. 53. Step (e) further comprises: in the form of a nickel-titanium alloy;
53. The method of claim 52, comprising providing the guide portion of the second guidewire. 54. The method of claim 52, wherein step (e) further comprises providing the guiding portion of the second guidewire in the form of a superelastic material. 55. The method of claim 47, wherein step (f) further comprises causing the guide portion to exert a radial outward force on the pilot lumen. 56. Step (e) further comprises providing the guide portion from a shape memory material, wherein the shape memory material, when the guide portion extends through a lumen of the torque member, 5. A device having sufficient flexibility to exhibit a substantially linear shape.
7. The method according to 7. 57. The method of claim 47, wherein step (e) further comprises providing the guide portion from a material that remains in its elastic state as the guide portion extends through the lumen of the torque member. The method described in. 58. A method of treating an area of an occluding substance in a body lumen, comprising: a. Creating an initial pilot lumen through the occluding material; b. Introducing a guide mechanism into the initial pilot lumen, the guide mechanism having a curvilinear profile that places a portion of the guide mechanism adjacent the occluding material. , A step; and c. Advancing a removal mechanism along the guide mechanism to separate and remove a first plurality of generally converging curved channels to form a first passage through the occluding material, the first passage comprising: Is diametrically larger than the pilot lumen. 59. The method further comprising: d. Advancing the removal mechanism further along the guide mechanism to separate and remove a second plurality of generally converging curved channels to form a second passageway through the occluding material; The two passages are diametrically larger than the first passage,
59. The method of claim 58, comprising the step of: 60. Step (d) further comprises the following steps: d1. 60. The method of claim 59, comprising increasing the size of the curvilinear profile of the guide mechanism and placing a portion of the guide mechanism adjacent the occluding material. 61. Step (c) further comprises the following steps: c1. Advancing the removal mechanism along the guide mechanism to separate and remove the first curvilinear channel; c2. Axially translating the guide mechanism within the pilot lumen; and c3. Advancing the removal mechanism along the guide mechanism to separate and remove the second curved channel, wherein the second curved channel merges with the first curved channel. 59. The method of claim 58, comprising: 62. The method of claim 58, wherein step (b) further comprises providing a helical shape to the curvilinear profile. 63. The method of claim 58, wherein step (b) further comprises causing the guide mechanism to apply a radial outward force on the pilot lumen. 64. Step (b) further comprises providing the guide mechanism from a shape memory material, wherein the shape memory material extends when the guide mechanism extends through a lumen of the torque member. 6. A material having sufficient flexibility to exhibit a substantially linear shape.
9. The method according to 8. 65. The method of claim 58, wherein step (e) further comprises providing the guide mechanism from a material that remains in its elastic state as the guide mechanism extends through the lumen of the torque member. The method described in. 66. A system, comprising: (a) a catheter, comprising: a catheter body having a proximal end, a distal end, and a lumen therethrough; A cutting mechanism at the distal end of the catheter body to ablate material and direct it to the lumen; and (b) a guidewire defining a curved path. Wherein the catheter body is capable of advancing over the guidewire and deflecting the cutting mechanism over the curved path. 67. The system of claim 66, wherein the cutting mechanism has a width at its distal end no greater than 1.2 times the width of the catheter body. 68. The method according to claim 66, wherein the cutting mechanism includes a helical blade and a torque member, the helical blade and the torque member being disposed within the lumen of the catheter body. The described system. 69. The system of claim 68, wherein the helical blade has a diameter at its distal end no greater than 1.5 times the width of the catheter. 70. The helical blade of claim 68, wherein the helical blade has a pair of blades, the blades being arranged as a double helix and tapering toward the distal end. system. 71. An atherectomy catheter comprising: a catheter body having a proximal end, a distal end, and a lumen therethrough; a torque member, proximal A distal end, a distal end, and a lumen therethrough, the torque member including an annular lumen between the torque member and the catheter body lumen;
A torque member rotatably disposed within the catheter body lumen; and a helical blade assembly mounted to the distal end of the torque member, tapered in a distal direction thereof. An atherectomy catheter, comprising: an assembly having an interior open to the annular lumen of the catheter body. 72. The atherectomy catheter according to claim 71, wherein the helical blade assembly includes at least two parallel helical blades. 73. The atherectomy catheter according to claim 72, further comprising a helical screw, wherein the helical screw is formed on at least a distal portion of the torque member. 74. The atheroma according to any of claims 71 to 73, further comprising means for applying a vacuum to said annular lumen to collect material drawn proximally through said lumen. Resection catheter. 75. A method of treating a region of an occluding substance in a body lumen, the method comprising: disposing a guidewire having at least one curve in the region, wherein the curve comprises a curve. A portion resiliently meshing with a periphery of the region; and advancing a cutting blade over the guidewire to excise occluding material from the lumen. 76. The step of disposing the guidewire includes a step of advancing a linear guidewire into the region, and thereafter, positioning the linear guidewire in a geometry having at least one curve. 77. The method of claim 75, comprising directing to exhibit. 77. The method of claim 76, wherein the guidewire is heated to induce a phase transition that causes the guidewire to spiral. 78. The method of claim 75, wherein advancing the cutting blade comprises rotating a helical blade. 79. The method of claim 78, further comprising collecting the ablated material from the internal volume within the helical blade and removing the collected material from the body lumen. . 80. A method of treating an area of an occluding substance in a body lumen, the method comprising: introducing a guidewire through the area; heating the guidewire to reduce at least one curve. Guiding; and advancing a removal mechanism over the guidewire, wherein the curved portion engages the removal mechanism with a periphery of the area. how to. 81. The guidewire is a shape memory alloy, and the heating induces a phase transition from a martensite phase to an austenite phase, wherein the austenite phase has a curved shape. 81. The method of claim 80. 82. The method of claim 80, wherein the curve is a spiral. 83. The method of claim 80, wherein advancing the removal mechanism comprises rotating a cutting blade. 84. The method of claim 83, wherein rotating the cutting blade comprises rotating a tapered helical cutting blade. 85. A method of removing hyperplastic material from the interior of a stent in an artery, comprising: disposing a helical guidewire within the stent mounting area of the artery; a removal mechanism over the guidewire. Advancing to create a helical channel in the hyperplastic material; and repeating advancing the removal mechanism over the guidewire a sufficient number of times to expose at least a portion of the stent. A method comprising: 86. The step of disposing the guidewire includes a step of advancing a linear guidewire into the stent mounting area, and thereafter, positioning the linear guidewire with at least one curved portion. 86. The method of claim 85, comprising directing to assume an arrangement. 87. The method of claim 86, wherein the guidewire is heated to induce a phase transition that causes the guidewire to spiral. 88. The method of claim 85, wherein advancing the removal mechanism comprises rotating a cutting blade. 89. The method of claim 88, wherein rotating the cutting blade comprises rotating a tapered helical cutting blade. 90. The method of claim 8, wherein the advancing step is repeated at least twice.
5. The method according to 5. 91. The method of claim 85, wherein energy is transferred to said guidewire to increase its width during continuous advancement of said removal mechanism. 92. A method of manufacturing a guidewire having a radially inflatable guide portion, comprising the steps of: (a) wrapping a core wire around a mandrel; (C) heating the mandrel assembly to a temperature between 300 ° C. and 800 ° C .; (d) stopping the heating; (e) cooling the mandrel assembly to room temperature. And (f) removing the conductor from the mandrel. 93. At least one of the following steps: (g) coating the core with a biocompatible material; (h) attaching a coil wire to the core; 93. The method of making a guidewire of claim 92, comprising providing an atraumatic tip at the distal end. 94. The method of claim 92, wherein the conductor has a tapered profile, the profile having a large diameter at a proximal portion and a narrow profile at a distal portion. 95. The method of claim 92, wherein step (a) comprises using a core at least partially composed of a shape memory material or alloy. 96. The method of claim 92, wherein step (a) comprises using a core comprised of nickel-titanium, or stainless steel with a shape memory material laminate, or stainless steel with a shape memory sandwich. The method described in. 97. Step (a) comprises using a core composed of at least one wire in a shape memory material matrix, said shape memory matrix acting in particular as a guide wire. 92.
The method described in. 98. Step (a) further comprises 0.0005 inches and 0.020 inches.
93. The method of claim 92, comprising wrapping the conductor segment around the mandrel having a diameter between inches. 99. The method of claim 92, wherein step (a) further comprises winding the core wire around the mandrel such that the spacing between each turn is 1 to 3 mm. Method. 100. The mandrel of step (a) further includes a helical channel around the mandrel to provide a pre-set configuration, wherein the channel has a. 93. A mandrel diameter between 5 mm and 20 mm with a spacing of 1 mm to 3 mm, wherein the mandrel diameter is preferably 1 mm to 6 mm.
The method described in. 101. The method of claim 92, wherein step (a) further comprises ensuring that the core is wound without looseness in the wire coil. 102. Step (b) further comprises using means for securing the core around the mandrel to ensure that the core is not unraveled and slippery. Item 90. The method according to Item 92. 103. Step (c) further comprises the step of attaching the mandrel assembly to 450
93. The method of claim 92, comprising heating to a temperature between 0C and 550C. 104. The method of claim 103, wherein the mandrel assembly remains at a constant temperature for 1-2 minutes. 105. The method of claim 92, wherein step (e) further comprises quenching the mandrel assembly. 106. The method of claim 92, further comprising coating the core with a laminate to reduce the coefficient of friction of the core. 107. The method of claim 92, further comprising attaching an atraumatic element to the cord or filament wire. 108. A mandrel for shaping a wire having a radially inflatable guide portion, the mandrel including a temperature stable nucleus and at least one thread, wherein the thread is , Having spaced threaded valleys, the threaded valleys being capable of mechanically receiving a wire, wherein the mandrel has at least one retaining device, the retaining device having the spaced A mandrel for securing the wire within the threaded root and preventing the wire from slipping or moving. 109. The mandrel of claim 108, wherein the mandrel has a uniform or non-uniform valley diameter between 0.5 mm and 20 mm. 110. The mandrel of claim 108, wherein the mandrel has a uniform or non-uniform linear geometry. 111. The mandrel of claim 108, wherein the mandrel has a plurality of cross-sectional geometries. 112. The mandrel of claim 108, wherein the cross-sectional geometry is any combination of regular and irregular shapes. 113. The mandrel of claim 108, wherein the mandrel further has a root diameter of 0.5 mm to 20 mm. 114. The mandrel of claim 108, wherein the pitch is between 0.001 inches and 0.5 inches. 115. The mandrel of claim 108, wherein the mandrel is hollow. 116. The mandrel of claim 108, wherein said mandrel is one of brass, stainless steel or ceramic. 117. The mandrel according to claim 108, wherein said retaining device is a screw or tube slidably fitted over said mandrel.