Source: https://patents.google.com/patent/US20120191121A1/en
Timestamp: 2019-04-25 04:20:20+00:00

Document:
Various embodiments of a tissue cutting device are described, such as a device with an elongate tube having a proximal end and a distal end and a central axis extending from the proximal end to the distal end; a first annular element at the distal end of the elongate tube, the first annular element having a flat portion at its distal end perpendicular to the central axis, the flat portion extending from an outer circumference of the first annular element to the central axis; and a second annular element at the distal end of the elongate tube and concentric with the first annular element, the second annular element having a flat portion at its distal end perpendicular to the central axis, at least one of the first or second annular elements rotatable about the central axis, the rotation causing the first annular element and the second annular element to pass each other to shear tissue.
This Application claims priority to U.S. Application No. 61/234,989, filed Aug. 18, 2009, entitled “Concentric Cutting Devices for use in Minimally Invasive Medical Procedures,” which is incorporated by reference as if fully set forth herein.
Embodiments of the present invention relate to micro-scale and millimeter-scale cutting devices that may be located at the distal ends of, or at intermediate positions along the length of, a lumen to provide material cutting, shredding, and removal. Such devices may, for example, be used to remove unwanted tissue or other material from selected locations within a body of a patient during minimally invasive or other medical procedures. In some embodiments, such devices may be used for non-medical procedure and in some embodiments the devices may be made in whole or in part using multi-layer, multi-material fabrication methods such as electrochemical fabrication methods.
An electrochemical fabrication technique for forming three-dimensional structures from a plurality of adhered layers is being commercially pursued by Microfabrica®Inc. (formerly MEMGen Corporation) of Van Nuys, Calif. under the name EFAB®.
(1) A. Cohen, G. Zhang, F. Tseng, F. Mansfeld, U. Frodis and P. Will, “EFAB: Batch production of functional, fully-dense metal parts with micro-scale features”, Proc. 9th Solid Freeform Fabrication, The University of Texas at Austin, p 161, August 1998.
(2) A. Cohen, G. Zhang, F. Tseng, F. Mansfeld, U. Frodis and P. Will, “EFAB: Rapid, Low-Cost Desktop Micromachining of High Aspect Ratio True 3-D MEMS”, Proc. 12th IEEE Micro Electro Mechanical Systems Workshop, IEEE, p 244, January 1999.
(8) A. Cohen, “Electrochemical Fabrication (EFAB™)”, Chapter 19 of The MEMS Handbook, edited by Mohamed Gad-El-Hak, CRC Press, 2002.
Various mechanical material breakdown and/or removal methods and devices have been proposed and/or used in minimally invasive medical applications such as thrombectomy and atherectomy procedures. These devices can be used in medical procedures including planning, coring, milling, and drilling. Such devices, for example, have included the use of cutting elements, shaving elements, and grinding elements. Examples of cutting devices are found, for example in (1) US Patent Application Publication No. 2006/0212060 A1, entitled “Arthroscopic Shaver and Method of Manufacturing Same” by Randall L. Hacker, et al. and assigned to Arthex, Inc.; (2) U.S. Pat. No. 6,447,525; (3) U.S. Pat. No. 7,479,147; and (4) U.S. Pat. No. 7,235,088.
Planing devices can be used to surface thin layers of tissue, e.g. for removing scars from the surface of the skin. Conventional planing devices include at least one sharp edge that can be translated across the tissue to remove the top-most layer. Such cutting surfaces in conventional planing devices generally have dimensions that are too large to cut thin slices of tissue, e.g. to cut slices of tissue having a thickness less than 50 μm, and these devices therefore cannot precisely remove small areas of tissue.
Coring devices can be used for biopsying tissue. Conventional coring devices generally include a needle that bores into the tissue. Conventional coring devices tend to cause pulling of and damage to surrounding tissue as the needle is pushed in. The rapid forward movement of the needle can also push aside the target tissue, such as a suspected tumor, especially if the target tissue is firmer than the surrounding tissue. Further, conventional coring devices do not have small enough feature sizes to remove only small tissue particles, again resulting in excessive damage to surrounding tissue.
Milling devices, such as debriders, can be used for de-bulking, e.g. for surgical removal of a malignant tumor. Conventional debriders include a rounded or pointed distal end to aid in removing specific tissue. However, such conventional milling devices are disadvantageous in that they often remove too much tissue and, due to their rounded ends, cannot selectively remove surface tissue. Further, conventional milling devices have dimensions that are generally too large to precisely remove small areas of tissue.
Drilling devices, such as atherectomy devices, are used to cut through tissue in the body. For example, atherectomy devices are used to treat atherosclerosis, in which the arteries are obstructed due to the accumulation of plaque and neointimal hyperplasia. Such atherectomy devices work by cutting away or excising the obstructing plaque to help restore blood flow. Drilling devices are configured in a variety of ways, but generally include employing a rotatable and/or axially translatable cutting blade or abrasive end which can be advanced into the occluding material and rotated or translated to cut away the desired material. Conventional drilling devices, however, have several drawbacks. Namely, the minimum feature size and shape of such devices, e.g. the size and shape of the cutting blades, are often too large to cut specifically and precisely, such as down to a micrometer or cellular scale. As a result, such devices tend to either leave unwanted tissue in the body, such as plaque in the blood vessel, or cut too much tissue, thereby injuring surrounding tissue. Further, traditional drilling devices have a fairly large diameter, e.g. over 2 mm, and are not configured to fit into small lumens, such as blood vessels, having a smaller diameter. As a result, some areas in the body are unreachable by conventional drilling devices.
Accordingly, there is a need for small tissue-cutting devices, such as planing, coring, milling, or drilling devices, that can precisely cut tissue down to a micrometer or cellular scale.
It is an object of some embodiments of the invention to provide improved millimeter-scale or micro-scale devices that may be used in minimally invasive procedure to provide therapeutic, diagnostic, or preventive treatment.
One aspect of the invention provides a tissue cutting device with an elongate tube having a proximal end and a distal end and a central axis extending from the proximal end to the distal end; a first annular element at the distal end of the elongate tube, the first annular element having a flat portion at its distal end perpendicular to the central axis, the flat portion extending from an outer circumference of the first annular element to the central axis; and a second annular element at the distal end of the elongate tube and concentric with the first annular element, the second annular element having a flat portion at its distal end perpendicular to the central axis, at least one of the first or second annular elements rotatable about the central axis, the rotation causing the first annular element and the second annular element to pass each other to shear tissue. In various embodiments, the elongate tube may have a diameter less than 5 mm, at least one of the first and second annular elements may have a tooth having a radial thickness of less than 50 microns, and/or the flat portion may have an axial thickness of less than 100 microns. Some embodiments of the invention have an intake window at the distal end of the elongate tube.
In some embodiments, the first annular element is rotatable about the central axis in an opposite direction from the second annular element. In some embodiments, the first annular element is rotatable about the central axis in a same direction as the second annular element, and the first annular element and the second annular element being configured to be rotated at different speeds.
In some embodiments, the tissue cutting device includes a hole extending along the central axis. In such embodiments, there may also be an ancillary component extending through the hole, such as an imaging element, a guide wire, a water jet tube, or a barbed device.
Some embodiments also have a third annular element and a fourth annular element, the third and fourth annular elements located between the proximal and distal ends, at least one of the third or fourth annular elements configured to rotate, the rotation causing the third and fourth annular elements to rotate past each other to further shear the tissue.
Another aspect of the invention provides a tissue cutting device with an elongate tube having a proximal end and a distal end and a central axis extending from the proximal end to the distal end; a first annular element at the distal end of the elongate tube; a second annular element at the distal end of the elongate tube and concentric with the first annular element, at least one of the first or second annular elements rotatable about the central axis, the rotation causing the first annular element and the second annular element to pass each other to shear tissue; wherein the first and second elements together form a conical shape at the distal end of the elongate tube; and wherein edges of the first and second tubular element are beveled to further shear tissue. In various embodiments the elongate tube may have a diameter less than 5 mm and the beveled edges may have a thickness less than 10 microns.
In some embodiments, the first annular element is rotatable about the central axis in an opposite direction from the second annular element. In some embodiments, the first and second elements together form a second conical shape, the second conical shape facing proximally. In some embodiments the first annular element is rotatable about the central axis in a same direction as the second annular element, the first annular element and the second annular element being configured to be rotated at different speeds.
Some embodiments of the tissue cutting device may have an intake window at the distal end of the elongate tube. Some embodiments may have a hole extending along the central axis and, optionally, an ancillary component extending through the hole, such as an imaging element, a guide wire, a water jet tube, or a barbed device.
In some embodiments, the tissue cutting device includes a third annular element and a fourth annular element, the third and fourth annular elements located between the proximal and distal ends, at least one of the third or fourth annular elements configured to rotate, the rotation causing the third and fourth annular elements to rotate past each other to further shear the tissue.
Yet another aspect of the invention provides a tissue cutting device with an elongate tube having a proximal end and a distal end and a central axis extending from the proximal end to the distal end; a first annular element at the distal end of the elongate tube; a second annular element at the distal end of the elongate tube and concentric with the first annular element, at least one of the first or second annular elements rotatable about the central axis; wherein the first and second annular elements each have an axially-extending cutting surface, the rotation causing the axially-extending surfaces of the first and second annular elements to pass each other to shear tissue, and wherein the first and second annular elements each have a radially-extending cutting surface, rotation causing the axially-extending surfaces of the first and second elements to pass each other to shear tissue, wherein the axially extending cutting surface has an axial length of less than 100 microns.
In some embodiments, the tissue cutting device may have teeth extending along the axially-extending or radially-extending cutting surfaces. In various embodiments the elongate tube may have a diameter less than 0.5 mm.
In some embodiments, the first annular element is rotatable about the central axis in an opposite direction from the second annular element. In some embodiments, the first annular element is rotatable about the central axis in a same direction as the second annular element, the first annular element and the second annular element being configured to be rotated at different speeds.
Some embodiments of the tissue cutting device have an intake window at the distal end of the elongate tube. Some embodiments of the invention have a hole extending along the central axis and, optionally, an ancillary component extending through the hole, such as an imaging element, a guide wire, a water jet tube, or a barbed device.
Still another aspect of the invention provides a tissue cutting device with an elongate tube having a proximal end and a distal end and a central axis extending from the proximal end to the distal end; a first annular element at the distal end of the elongate tube; a second annular element at the distal end of the elongate tube and concentric with the first annular element, at least one of the first or second annular elements rotatable about the central axis; wherein the first and second annular elements each include axially-extending teeth, the teeth having a radial thickness of less than 10 microns, the rotation causing the teeth of the first annular element and the teeth of the second annular element to pass each other to shear tissue. In some embodiments, the elongate tube has a diameter less than 5 mm.
In some embodiments of the tissue cutting device, the teeth have a pitch of less than 200 microns. Some embodiments also provide an intake window at the distal end of the elongate tube. In some embodiments, the tissue cutting device includes a hole extending along the central axis and, optionally, an ancillary component extending through the hole, such as an imaging element, a guide wire, a water jet tube, or a barbed device. In some embodiments, the tissue cutting device includes a third annular element and a fourth annular element, the third and fourth annular elements located between the proximal and distal ends, at least one of the third or fourth annular elements configured to rotate, the rotation causing the third and fourth annular elements to rotate past each other to further shear the tissue.
Another aspect of the invention provides a tissue cutting device with an elongate tube having a proximal end and a distal end and a central axis extending from the proximal end to the distal end; a first annular element at the distal end of the elongate tube, the first annular element including a plurality of first shearing elements, each first shearing element having a perpendicular shearing surface that is perpendicular to the central axis; a second annular element at the distal end of the elongate tube and concentric with the first annular element, the second annular element including a plurality of second shearing elements, each second shearing element having a perpendicular shearing surface that is perpendicular to the central axis, wherein at least one of the first or second annular elements is rotatable about the central axis, the rotation causing the perpendicular shearing surfaces of the first shearing elements and the perpendicular shearing surfaces of the second shearing elements to pass each other to shear tissue. In some embodiments, the elongate tube may have a diameter of less than 5 mm.
In some embodiments, at least some of the perpendicular shearing surfaces of the first shearing elements lie along the same plane and, optionally, at least some of the perpendicular shearing surfaces are located at the same radial distance from the central axis.
In some embodiments, at least some of the perpendicular shearing surfaces do not lie along the same plane and, optionally, at least some perpendicular shearing surfaces are located at different radial distances from the central axis.
In some embodiments, each first shearing element has a parallel shearing surface that is parallel to the central axis; wherein each second shearing element has a parallel shearing surface that is parallel to the central axis; and wherein rotation of the second annular element causes the causes the parallel shearing surfaces of the first shearing elements and the parallel shearing surfaces of the second shearing elements to pass each other to shear tissue. In some such embodiments, at least some of the parallel shearing surfaces of the first shearing elements lie along the same radial plane and, optionally, the at least some parallel shearing surfaces are spaced apart from each other circumferentially. In some embodiments, at least some of the parallel shearing surfaces of the first shearing elements are spaced apart from each other radially.
Still another aspect of the invention provides a tissue cutting device with an elongate tube having a proximal end and a distal end and a central axis extending from the proximal end to the distal end; a first annular element at the distal end of the elongate tube, the first annular element including a plurality of first shearing elements, each first shearing element having a parallel shearing surface that is parallel to the central axis; a second annular element at the distal end of the elongate tube and concentric with the first annular element, the second annular element including a plurality of second shearing element, each second shearing element having a parallel shearing surface that is parallel to the central axis, wherein at least one of the first or second annular elements is rotatable about the central axis, the rotation causing the parallel shearing surfaces of the first shearing elements and the parallel shearing surfaces of the second shearing elements to pass each other to shear tissue.
In some embodiments, at least some of the parallel shearing surfaces of the first shearing elements lie along the same radial plane. In some such embodiments, the at least some of the parallel shearing surfaces are spaced apart from each other axially and, optionally, the at least some of the parallel shearing surfaces are spaced apart from each other circumferentially.
In some embodiments, at least some of the parallel shearing surfaces of the first shearing elements are spaced apart from each other radially. In some embodiments, the elongate tube may have a diameter of less than 5 mm.
In another aspect, a cutting device includes an elongate tube having a proximal end and a distal end, a first annular element at the distal end of the elongate tube, and a second annular element at the distal end of the elongate tube. The elongate tube has a central axis extending from the proximal end to the distal end. The first annular element includes at least one surface, and the at least one surface has a first shearing element. The second annular element includes at least one second surface, and the at least one second surface includes a second shearing element. The second annular element is concentric with the first annular element and rotatable about a central axis. The rotation causes the first shearing elements and the second shearing elements to pass each other.
This and other embodiments may include one or more of the following features. At least one surface can be perpendicular to the central axis. At least one surface can be parallel to the central axis. At least a portion of the at least one surface that is perpendicular can be located at the radial-most location of the first or second annular elements. The total radial length occupied by the at least one perpendicular surface can be at least 1/10, such as at least ⅕, such as at least ¼, such as at least ⅓, such as at least ½ of the radius of the cutting device. The at least one surface can be spaced apart from the central axis. There can be at least two surfaces occupy different planes which are perpendicular to the central axis. There can be at least two surfaces that are on a common plane and separated by a gap. The distance between the first shearing element and the second shearing element can be less than 20 microns, such as less than 10 microns, such as less than 5 microns, such as approximately 1 micron. The first and second shearing elements can be in contact when passing each other. The shearing elements can be substantially parallel to the central axis. The distance from the shearing element to the central axis can be less than ⅞ of the radius, such as less than ¾ of the radius, such as less than ⅝ of the radius, such as less than ½ of the radius from the central axis. There can be alternating shearing elements that are perpendicular and parallel to the central axis, such as to form a stair-like profile. Each surface can have a plurality of shearing elements.
In another aspect, a cutting device includes an elongate tube having a proximal end and a distal end, a first annular element at the distal end of the elongate tube, and a second annular element at the distal end of the elongate tube. The elongate tube has a central axis extending from the proximal end to the distal end. The first annular element includes at least one first blade element. The at least one first blade element can include a first front surface and a first back surface, the first front surface including a first front shearing element, and the first back surface including a first back shearing element. The second annular element includes at least one second blade element. The at least one second blade element includes a second back surface and a second front surface. The second front surface includes a second front shearing element, and the second back surface includes a second back shearing element.
This and other embodiments can include one or more of the following features. The surfaces of the blades can be perpendicular to the central axis. The surfaces of the blades can be substantially parallel to the central axis. The first blade element can include at least one second blade element perpendicular to the first blade element. The distance between shearing elements of the first annular element and shearing elements of the second shearing elements can be less than 20 microns, such as less than 10 microns, such as less than 5 microns, such as approximately 1 micron. The shearing elements of the first annular element and the shearing elements of the second annular elements can be in contact when passing each other. The surfaces of the blades can have at least one tooth.
FIGS. 5A-5E illustrate an exemplary embodiment of a cutting device as described herein.
FIGS. 6A-6C illustrate an exemplary embodiment of a cutting device as described herein.
FIGS. 7A-7B illustrate an exemplary embodiment of a cutting device described herein.
FIG. 8 illustrates an exemplary embodiment of a cutting described herein.
FIG. 9 illustrates an exemplary embodiment of a cutting device described herein.
FIGS. 10A-10B illustrate an exemplary embodiment of a cutting device described herein.
FIGS. 11A-11B illustrate an exemplary embodiment of a cutting device described herein.
FIG. 12 illustrates an exemplary embodiment of a cutting device described herein.
FIG. 13 illustrates an exemplary embodiment of a cutting device described herein.
FIG. 14 illustrates an exemplary embodiment of a cutting device described herein.
FIGS. 15A-15B illustrate an exemplary embodiment of a cutting device described herein.
FIG. 16 illustrates an exemplary embodiment of a cutting device described herein.
FIGS. 17A-17C illustrate an exemplary embodiment of a cutting device described herein.
FIGS. 18 illustrates an exemplary embodiment of a cutting device described herein.
FIG. 19 illustrates an exemplary embodiment of a cutting device described herein.
FIGS. 20A-20H illustrate an exemplary embodiment of a cutting device described herein.
FIG. 21 illustrates an exemplary embodiment of a cutting device described herein.
FIGS. 22A-22B illustrate an exemplary embodiment of a cutting device described herein.
FIGS. 23A-23B illustrate an exemplary embodiment of a cutting device described herein.
FIGS. 24A-24B illustrate an exemplary embodiment of a cutting device described herein.
FIGS. 25A-25C illustrate an exemplary embodiment of a cutting device described herein.
FIGS. 26A-26C illustrate an exemplary embodiment of a cutting device described herein.
FIGS. 27A-27C illustrate an exemplary embodiment of a cutting device described herein.
FIGS. 28A-28B illustrate an exemplary embodiment of a cutting device described herein.
FIG. 29 illustrates an exemplary embodiment of a tissue cutting device having a working component extending therethrough.
FIGS. 30A-30G illustrate exemplary embodiments of working components that can extend through the medical devices described herein.
Various embodiments of various aspects of the invention are directed to formation of three-dimensional structures from materials some of which may be electrodeposited or electroless deposited. Some of these structures may be formed form a single build level formed from one or more deposited materials while others are formed from a plurality of build layers each including at least two materials (e.g. two or more layers, more preferably five or more layers, and most preferably ten or more layers). In some embodiments, layer thicknesses may be as small as one micron or as large as fifty microns. In other embodiments, thinner layers may be used while in other embodiments, thicker layers may be used. In some embodiments structures having features positioned with micron level precision and minimum features size on the order of tens of microns are to be formed. In other embodiments structures with less precise feature placement and/or larger minimum features may be formed. In still other embodiments, higher precision and smaller minimum feature sizes may be desirable. In the present application meso-scale and millimeter scale have the same meaning and refer to devices that may have one or more dimensions extending into the 0.5-20 millimeter range, or somewhat larger and with features positioned with precision in the 10-100 micron range and with minimum features sizes on the order of 100 microns.
Patterning operations may be used in selectively depositing material and/or may be used in the selective etching of material. Selectively etched regions may be selectively filled in or filled in via blanket deposition, or the like, with a different desired material. In some embodiments, the layer-by-layer build up may involve the simultaneous formation of portions of multiple layers. In some embodiments, depositions made in association with some layer levels may result in depositions to regions associated with other layer levels (i.e. regions that lie within the top and bottom boundary levels that define a different layer's geometric configuration). Such use of selective etching and interlaced material deposition in association with multiple layers is described in U.S. Pat. No. 7,252,861, which is hereby incorporated herein by reference as if set forth in full.
Temporary substrates on which structures may be formed may be of the sacrificial-type (i.e. destroyed or damaged during separation of deposited materials to the extent they cannot be reused), non-sacrificial-type (i.e. not destroyed or excessively damaged, i.e. not damaged to the extent they may not be reused, e.g. with a sacrificial or release layer located between the substrate and the initial layers of a structure that is formed). Non-sacrificial substrates may be considered reusable, with little or no rework (e.g. replanarizing one or more selected surfaces or applying a release layer, and the like) though they may or may not be reused for a variety of reasons.
“Build layer” or “layer of structure” as used herein does not refer to a deposit of a specific material but instead refers to a region of a build located between a lower boundary level and an upper boundary level which generally defines a single cross-section of a structure being formed or structures which are being formed in parallel. Depending on the details of the actual process used to form the structure, build layers are generally formed on and adhered to previously formed build layers. In some processes the boundaries between build layers are defined by planarization operations which result in successive build layers being formed on substantially planar upper surfaces of previously formed build layers. In some embodiments, the substantially planar upper surface of the preceding build layer may be textured to improve adhesion between the layers. In other build processes, openings may exist in or be formed in the upper surface of a previous but only partially formed build layers such that the openings in the previous build layers are filled with materials deposited in association with current build layers which will cause interlacing of build layers and material deposits. Such interlacing is described in U.S. patent application Ser. No. 10/434,519 now U.S. Pat. No. 7,252,861. This referenced application is incorporated herein by reference as if set forth in full. In most embodiments, a build layer includes at least one primary structural material and at least one primary sacrificial material. However, in some embodiments, two or more primary structural materials may be used without a primary sacrificial material (e.g. when one primary structural material is a dielectric and the other is a conductive material). In some embodiments, build layers are distinguishable from each other by the source of the data that is used to yield patterns of the deposits, applications, and/or etchings of material that form the respective build layers. For example, data descriptive of a structure to be formed which is derived from data extracted from different vertical levels of a data representation of the structure define different build layers of the structure. The vertical separation of successive pairs of such descriptive data may define the thickness of build layers associated with the data. As used herein, at times, “build layer” may be loosely referred simply as “layer”. In many embodiments, deposition thickness of primary structural or sacrificial materials (i.e. the thickness of any particular material after it is deposited) is generally greater than the layer thickness and a net deposit thickness is set via one or more planarization processes which may include, for example, mechanical abrasion (e.g. lapping, fly cutting, polishing, and the like) and/or chemical etching (e.g. using selective or non-selective etchants). The lower boundary and upper boundary for a build layer may be set and defined in different ways. From a design point of view they may be set based on a desired vertical resolution of the structure (which may vary with height). From a data manipulation point of view, the vertical layer boundaries may be defined as the vertical levels at which data descriptive of the structure is processed or the layer thickness may be defined as the height separating successive levels of cross-sectional data that dictate how the structure will be formed. From a fabrication point of view, depending on the exact fabrication process used, the upper and lower layer boundaries may be defined in a variety of different ways. For example by planarization levels or effective planarization levels (e.g. lapping levels, fly cutting levels, chemical mechanical polishing levels, mechanical polishing levels, vertical positions of structural and/or sacrificial materials after relatively uniform etch back following a mechanical or chemical mechanical planarization process). For example, by levels at which process steps or operations are repeated. At levels at which, at least theoretically, lateral extends of structural material can be changed to define new cross-sectional features of a structure.
“Secondary structural material” as used herein is a structural material that forms part of a given build layer and is typically deposited or applied during the formation of the given build layer but is not a primary structural material as it individually accounts for only a small volume of the structural material associated with the given layer. A secondary structural material will account for less than 20% of the volume of the structural material associated with the given layer. In some preferred embodiments, each secondary structural material may account for less than 10%, 5%, or even 2% of the volume of the structural material associated with the given layer. Examples of secondary structural materials may include seed layer materials, adhesion layer materials, barrier layer materials (e.g. diffusion barrier material), and the like. These secondary structural materials are typically applied to form coatings having thicknesses less than 2 microns, 1 micron, 0.5 microns, or even 0.2 microns). The coatings may be applied in a conformal or directional manner (e.g. via CVD, PVD, electroless deposition, or the like). Such coatings may be applied in a blanket manner or in a selective manner. Such coatings may be applied in a planar manner (e.g. over previously planarized layers of material) as taught in U.S. patent application Ser. No. 10/607,931, now U.S. Pat. No. 7,239,219. In other embodiments, such coatings may be applied in a non-planar manner, for example, in openings in and over a patterned masking material that has been applied to previously planarized layers of material as taught in U.S. patent application Ser. No. 10/841,383, now U.S. Pat. No. 7,195,989. These referenced applications are incorporated herein by reference as if set forth in full herein.
“Secondary sacrificial material” as used herein is a sacrificial material that is located on a given build layer and is typically deposited or applied during the formation of the build layer but is not a primary sacrificial materials as it individually accounts for only a small volume of the sacrificial material associated with the given layer. A secondary sacrificial material will account for less than 20% of the volume of the sacrificial material associated with the given layer. In some preferred embodiments, each secondary sacrificial material may account for less than 10%, 5%, or even 2% of the volume of the sacrificial material associated with the given layer. Examples of secondary structural materials may include seed layer materials, adhesion layer materials, barrier layer materials (e.g. diffusion barrier material), and the like. These secondary sacrificial materials are typically applied to form coatings having thicknesses less than 2 microns, 1 micron, 0.5 microns, or even 0.2 microns). The coatings may be applied in a conformal or directional manner (e.g. via CVD, PVD, electroless deposition, or the like). Such coatings may be applied in a blanket manner or in a selective manner. Such coatings may be applied in a planar manner (e.g. over previously planarized layers of material) as taught in U.S. patent application Ser. No. 10/607,931, now U.S. Pat. No. 7,239,219. In other embodiments, such coatings may be applied in a non-planar manner, for example, in openings in and over a patterned masking material that has been applied to previously planarized layers of material as taught in U.S. patent application Ser. No. 10/841,383, now U.S. Pat. No. 7,195,989. These referenced applications are incorporated herein by reference as if set forth in full herein.
“Moderately complex multilayer three-dimensional (or 3D or 3-D) structures” are complex multilayer 3D structures for which the alternating of void and structure or structure and void not only exists along one of a vertically or horizontally extending line but along lines extending both vertically and horizontally.
“Highly complex multilayer (or 3D or 3-D) structures” are complex multilayer 3D structures for which the structure-to-void-to-structure or void-to-structure-to-void alternating occurs once along the line but occurs a plurality of times along a definable horizontally or vertically extending line.
“Sublayer” as may be used herein refers to a portion of a build layer that typically includes the full lateral extents of that build layer but only a portion of its height. A sublayer is usually a vertical portion of build layer that undergoes independent processing compared to another sublayer of that build layer.
Various cylindrical cutting devices or instrument embodiments will be discussed below. These devices may be used in a number of different tissue removal methods, such as planing, coring, milling, or drilling. Such tissue removal methods can be used in various applications including: (1) Disc, other tissue, or bone in the spinal region, for example, to relieve pressure on spinal nerves, (2) Ear, nose (sinus), and throat surgery, (3) ophthalmic procedures such as cataract surgery; (4) Cardiovascular (can be delivered over a guide wire) surgery or procedures such as (a) Blood clot removal (Thrombectomy); (b) Chronic total occlusion (CTO); (c) Atherectomy; (d) Removal of heart tissue; (5) Neurovascular procedures such as thrombectomy; (6) Breast surgeries or procedures such as (a) Breast duct papilloma, and (b) Lumpectomy; (7) Orthopedic surgeries and procedures such as (a) Joint surgeries; (b) Removal of bone spurs; and (c) Arthroscopic surgeries; (8) Peripheral artery disease surgeries and procedures; (9) other thrombectomy and atherectomy procedures and (10) Removal of tumors, cancerous tissue, and other excess tissue masses. The devices of various embodiments of the invention may also be used in non-medical applications.
The cutting devices described herein can advantageously be constructed using the electrochemical fabrication process. Using the electrochemical fabrication process allows the devices to be on the micrometer or nanometer scale and have precision on the order of tens of microns. Medical devices having such scale and precision are advantageous over conventional medical devices because they can be sharper, have more cutting surfaces, and be more intricately shaped. As a result, the medical devices described herein can be used for selective and accurate removal of tissue or other material within the body.
Further, using the electrochemical fabrication process is advantageous because the scale and precision available by doing so allows the medical devices to be configured to be used in conjunction with additional therapeutic or diagnostic elements. For example, the medical devices described herein may be used in conjunction with ancillary components extending through the center of the device, such as guide wires, endoscopes or other imaging methods (IVUS, OCT, OFDI, etc), aspiration, irrigation, and other micro-scale or millimeter-scale devices and instruments such as distal protection devices (see U.S. patent application Ser. No. 12/179,573), positioning instruments such as expanders (see U.S. patent application Ser. No. 12/179,573), other tissue shredding devices such as those described in U.S. patent application Ser. No. 12/490,301, and guiding and configurable elements such as those described in U.S. patent application Ser. Nos. 12/169,528; 12/179,295; and 12/144,618.
Although the medical devices described herein can be produced using the electrochemical fabrication process, additional fabrication processes may also be used.
The cutting devices described herein can each include two concentric components, which can be configured to rotate relative to one another to perform the desired surgical function. As such, only one concentric component can be rotated, both can be rotated in opposite directions, or both can be rotated in the same direction, but at different rates. The dimensions of the various cutting devices can be adjusted to obtain a desired degree of tissue removal.
FIGS. 5A-5E illustrate a cutting device 100. The first component 101 of the device 100 includes an inner cutting element 102, having a primary cutting surface 103 and a secondary cutting surface 104. The second component 111 likewise includes an outer cutting element 112, having a primary surface 113 and a secondary surface 114. When assembled as shown in FIG. 5E, the first component 101 is capable of rotating relative to the second component 111, and the interaction of the cutting surfaces can cause shearing away of layers of tissue or other material as the inner and outer cutting elements rotate past one another. In some embodiments, either or both components can be configured to rotate in either direction. For example, the first component can rotate counter-clockwise, and the second component can rotate clockwise.
Both the inner and outer cutters 102, 112 can have singled-sided substantially radially-extending primary cutting surfaces 103 and 113 as well as secondary cutting surfaces 104 and 114 extending substantially axially at the radial extremes of the components. Having a primary cutting surface extending substantially radially and a secondary cutting surface extending substantially axially can be advantageous over prior art cutting devices because it provides more cutting surfaces for shearing off tissue. Further, the axial length of the secondary cutting surfaces 104 and 114 can be less than 100 microns, such as less than 50 microns, such as less than 10 microns. Such a small axial length allows for accurate removal of small layers of tissue, such as layers between 2 and 5 microns thick. Thus, for example, cutting device 100 can be used for planing of thin slices of tissue.
Teeth 105 and 115 can extend along the primary and/or the secondary cutting surfaces. The teeth 105 and 115 can all be configured such that they extend radially. The teeth 105 and 115 can be configured to, upon rotation of the first and second components 101, 111, engage one another substantially point-to-point, relative to a centered longitudinal axis 121 of relative rotation of the elements. The teeth 105 and 115 can aid in shearing off layers of tissue during the planing process.
As shown in the figures, the cutting surface of the first component 101 is supported by a sloped surface that sweeps a three-dimensional curve (i.e. sweeping in radial, axial or longitudinal, and azimuthal directions). The proximal facing portion of this sloped surface, when rotating in a counterclockwise direction, may aid in pushing sheared off material in a proximal and longitudinal direction to help remove material and ensure that the cutting surface of the blade is cleared of material and ready to shear off newly encountered material.
As shown, the first component 101 of device 100 includes an intake window 122. The intake window 122 can, for example, extend across at least one-half of the distal end of the cutting device, such as approximately one-half of the distal end of the cutting device. The intake window 122 permits tissue to extend into the interior of cutting device 100 to enable the interacting cutting surfaces of the first and second components to shear the tissue, for example during a planing process.
As shown in the figures the components may be formed with a plurality of etching or release holes so that the individual components may be formed using a multi-material, multi-layer fabrication method and then the sacrificial material readily removed. In alternative embodiments, fewer, more, or even no release holes may be formed. In some embodiments, the components may be formed using an interference bushings, or with intermediate bearing elements, for example, to provide smoother operation or tighter formation tolerances. In some alternative embodiments fluid flow paths and outlets may exist between the components and may receive a fluid during operation of the device so as to provide a fluid bearing for improved device operation.
The device 100 can be a micro-scale device. Thus, the diameter of the device 100 can be less than 5 mm, such as less than 3 mm, e.g. less than 1 mm. The minimum feature size can be on the order of tens of microns, i.e. less than 100 microns, such as less than 50 microns. Moreover, the precision of the device build can be on the micron level, i.e. between 1 and 10 microns. Having a micro-scale device can advantageously allow the device to be used in small areas of the body that are unreachable by larger devices. Moreover, the precision of the build and the minimum feature size can be useful for very precise and specific tissue removal, such as planing of tissue layers of only a few microns thick. These micro-scale devices may be made using the electrochemical fabrication process described above.
Various alternatives to this embodiment are possible and include, for example, alternative blade configurations and intake configurations. For example, the teeth of the cutting elements may be made to encounter one another other than in a tip-to-tip configuration, the teeth may be removed in favor of straight blades, and the cutting blades may have cutting surfaces that have lengths which extend not just radially but also have an azimuthal component of length as well. In some embodiments, the cutting elements may be provided with cutting surfaces to allow cutting in either direction of rotation. In some alternative embodiments, the intake opening, which is defined by the distal cap of component 111 may be made larger by decreasing the azimuthal sweep or extent of the cap or smaller by increasing the azimuthal extent of the cap. In some embodiments, different numbers of inner cutting elements may form part of the inner component (e.g. 1, 2, 3, 4, or more cutting elements), and different numbers of outer cutting elements may form part of the outer component, and in some embodiments, these numbers of inner and outer cutting elements need not match. In some embodiments, cutting elements may be contained on a single component, two components, or more than two components.
During use, the two components 101, 111 of this working end of the cutting device may have their proximal ends joined or otherwise coupled to tubes or other rotatable elements such that one component (i.e. each including its respective cutting elements) stays stationary while the other rotates, such the two components 101, 111 rotate in opposite directions, or such that the two components 101, 111 rotate in the same direction but at different rates such that they still move past one another to provide shearing. During some uses, the components 101, 111 may be made to periodically, or possibly upon input from sensors (e.g. an input indicating a stall or excess slowing of the rotation), rotate a partial rotation in reverse to provide an opportunity for additional shearing attempts. During some uses, the cutting may be accompanied by aspiration from distal to proximal end to provide enhanced transport of sheared off material. In some embodiments, aspiration may be accompanied by appropriately directed irrigation. In some embodiments, more proximally located cutting and/or transport elements can be included on the components 101, 111 to cause further maceration of the removed material or proximal transportation of the material.
In some alternative embodiments, the rotation of one or both of the concentric components may occur via one or more rotating tubes that may be located within a catheter. The tubes may be driven by rotational driving elements located at a significant distance from the working area that is being operated on (e.g. outside the body of a patient). In other embodiments, the rotating tubes or other elements may be driven by a fluid driven turbine (e.g. driven by an irrigation fluid of other fluid) that is located within the catheter or other instrumental lumen.
In some embodiments, the instrument components shown in FIGS. 5A-5E may be formed using one of the multi-layer multi-material fabrication processes set forth herein or incorporated herein by reference. In some embodiments, one of the components, or part the components may be made by one of these multi-layer multi-material fabrication process while the other component or component portions may be made by one or more different processes. In still other embodiments, both of the components may be made by processes other than multi-layer, multi-material fabrication process. For example, one or both components, or portions thereof may be made from a tube which is cut to a desired shape and then bent to a desired configuration and perhaps with portions welded or otherwise joined to maintain the created configuration.
FIGS. 6A-6C provide various views of a working end of a cutting device 200. The cutting device 200 includes first and second components 201 and 211. The first component 201 includes an inner cutting element 202, having a primary cutting surface 203 and a secondary cutting surface 204. The second component 211 includes an outer cutting element 212, having a primary surface 213 and a secondary surface 214. One or both of the first and second components 201, 211 is capable of rotating about a central longitudinal axis 221 to cause relative rotation with respect to one another. The interaction of cutting surfaces 203 and 204 with cutting surfaces 213 and 214, respectively, during such relative rotation can cause shearing away of tissue or other material as the inner and outer cutting elements rotate past one another.
Both the inner and outer cutters 202, 212 can have singled-sided radial extending, and slightly azimuthal extending, primary cutting surfaces 203 and 213 as well as secondary cutting surfaces 204 and 214 extending axially at the radial extremes of the components. Teeth 205 and 215 can extend radially along the primary and/or secondary cutting surfaces.
An intake window, such as an intake window 222 of the device exists on one-half of the distal end of the cutting device 200. The intake window 222 permits tissue to extend into the interior of cutting device 200 to enable the interacting cutting surfaces of the first and second components to shear the tissue, for example during a planing process. Further, a distal cap of element 211 is located on the other half of the distal end of the cutting device 200. The cutter 200 can have many of the same advantages of the cutter 100. For example, the cutter 100 can be a micro-scale device and can have thin axially-extending cutting surfaces, allowing for access to small areas and specific and precise removal of very small layers of tissue, such as during a planing process.
Numerous variations of the cutting device 200 exist, some of which are similar, mutatis mutandis, to those noted above with regard to the first embodiment.
FIGS. 7A-7B provide perspective and cut views of a working end of a cutting device 300. The first component 301 of the device 300 includes an inner cutting element 302 having optional teeth 305 that extend perpendicular to the axis of rotation and a secondary peripheral cutting surface 303 with axially-extending teeth 305. The second component 311 is disposed radially outward from first element 301 and includes an outer cutting element 312 with axially-extending teeth 315. The first component 301 is capable of rotating with respect to the second component 311, which causes shearing at the periphery due to the interaction of cutting surfaces 303 and 312 while the cutting surface 302 cuts a plane of tissue. Sloped surface 306 helps draw material from the distal end of the device toward the proximal end. In some embodiments, the first component can also be configured to rotate. For example, the first component can rotate counter-clockwise, and the second component can rotate clockwise.
Both cutting surfaces 304 and 312 are provided with teeth in a crown configuration, i.e. both have teeth extending axially. The teeth can be used to drive into tissue. The teeth can have a maximum radial thickness of less than 50 microns, such as approximately 30 microns. Further, the teeth can have a pitch of less than 200 microns, such as less than 100 microns. The device 300 can be used for coring and slicing a substantially circular plane of tissue, i.e. for conducting a biopsy. The small teeth of the cutting device 300 can allow for removal of very small tissue samples, such as samples that are less than 5 microns, such as between 2 and 5 microns. Removing such small samples avoids excessive damage to surrounding tissue.
The intake window 322 of the device 300 covers nearly the entire 360 degree azimuthal region of the components to allow tissue to extend proximally into the device for shearing and easy removal of the tissue sample for analysis. The device 300 can be a micro-scale device, allowing it access to otherwise inaccessible areas of the body and may be made using the electrochemical fabrication process described above.
Numerous variations the cutting device 300 exist, some of which are similar, mutatis mutandis, to those noted above with regard to cutting device 100.
FIGS. 8, 9, 13, and 16 show components of devices similar to device 300, i.e., that include axially-extending teeth. Thus, the devices can include many of the same features and advantages as device 300.
FIGS. 8 and 9 are similar to the cutting device 300 with the exception that the cutter 400 (FIG. 8) has the outer crown cutting teeth removed while the cutter 500 has both the inner and out crown cutting teeth removed.
FIG. 13 provides a perspective view of a working end of a cutting device 900 having first and second components 901 and 911. Similar to the other cutting devices described herein, the cutting device 900 includes teeth on each component 901, 911, respectively, that can shear against each other during rotation of one or both of the components 901, 911, to remove small pieces of tissue. Unlike the embodiment of FIG. 7, the first component 901 of the embodiment of FIG. 13 has two cutting elements 912 and two intake windows 914 for drawing in and removing tissue.
FIG. 16 provides a perspective view of a working end of a cutting device 1200 having first and second components 1201 and 1211. The device includes inner and outer crown cutters having teeth 1205 and 1215 extending substantially axially. The teeth 1205 are configured to bore into a material without any additional cutting elements. This embodiment omits the inner cutting element of the first component shown in FIG. 7.
Numerous variations on these embodiments are possible and include those, mutatis mutandis, set forth regard to any of the other embodiment set forth herein.
FIGS. 10A-10B provide a perspective and a perspective cut view respectively of a working end of a cutting device 600. The cutting device 600 includes first and second components 601 and 611 attached to a central shaft 640. The first component 601 includes an inner cutting element 602, having two primary cutting surfaces 603 and two secondary cutting surfaces 604. The second component 611 includes two outer cutting elements 612, having a primary surface 613 and a secondary surface 614. When assembled, first component 601 is disposed radially inward of second component 611. The first component 601 is capable of rotating relative to the second component 611 to cause shearing away of tissue or other material as the inner and outer cutting elements rotate past one another. In some embodiments, the first component can also be configured to rotate about the central longitudinal axis 621. For example, the first component can rotate counter-clockwise, and the second component can rotate clockwise.
Both the inner and outer cutters 602, 612 have two-sided radial extending, and slightly azimuthal extending, primary cutting surfaces 603 and 613, respectively. The primary cutting surfaces 603 and 613 can include teeth 607 and 617. Moreover, both the inner and outer cutters 602, 612 have secondary cutting surfaces 604 and 614 extending axially at the radial extremes of the components, which can also include teeth 605 and 615. An intake window 622 of the device consists of two opposite facing 90 degree wedges for drawing in tissue to be sheared between the rotating cutting surfaces and two sloping surfaces for drawing the sheared tissue proximally.
Advantageously, the distal end of the cutter 600 can have a flat portion 630 that extends from the outer circumference to the radial center of the cutter 600. The flat portion 630 can have an axial thickness of less than 100 microns, such as less than 50 microns. The spatial relationships between the flat surface, the cutting elements 603 and 613 and the intake windows 622 can allow for removal of tissue along a single plane, such as during a milling process, thereby avoiding removal of unwanted tissue.
Further, the cutter 600 can be a micro-scale device. Thus, the diameter of the device 600 can be less than less than 5 mm, such as less than 3 mm, e.g. less than 1 mm. The minimum feature size (e.g., the size of teeth 605 and 615) can be on the order of tens of microns, i.e. less than 100 microns, such as less than 50 microns. Moreover, the precision of the device build can be on the micron level, i.e. between 1 and 10 microns. Having a micro-scale milling device can advantageously allow the device to be used in small areas of the body that are unreachable by larger devices. Moreover, the precision of the build and the minimum feature size can be useful for very precise and specific tissue or material cutting. For example, tissue having a diameter of less than 5 microns, such as between 2 and 5 microns, can be removed during a milling process. Removing such small pieces avoids excessive damage to surrounding tissue. These micro-scale devices may be made using the electrochemical fabrication process described above.
Numerous variations of the cutter 600 exist, some of which are similar, mutatis mutandis, to those noted above. Additional variations may include the removal of the central rod shaft or the hollowing out of the shaft to form a ring element through which a guide wire, imagining device or other component may extend. In still other embodiment variations, the central rod may be a hollow shaft with perforation and may be connected to a proximal tube (e.g. with a rotatable coupling) that allows a flow of an irrigation fluid to be directed into the working region e.g. for aspiration along with removed material.
FIGS. 11, 12, 14, 15, 17, 23, 25 show similar devices to device 600, i.e., that include two rotating portions having flat distal surfaces. Thus, the devices can include many of the same features and advantages as device 600 and may be made using the electrochemical fabrication process described above.
FIGS. 11A and 11B provide a perspective and a perspective cut view respectively of a working end of a cutting device 700 having first and second components 701 and 711. The cutting device 700 is similar to that of cutter 600 with the exception of a different set of primary cutting blade configurations 703 and 713.
FIG. 12 provides a perspective view of a working end of a cutting device 800 having first and second components 801 and 811 that are configured to be rotated with respect to each other, as in the embodiments described above. The cutting device 800 has an inner cutter similar to that of cutter 600 with the exception that the central rod or shaft is removed so that a guide wire, imaging device or other element may be extended down the central axis of the device. The device also lacks an outer cutting element. Numerous variations of cutter 800 exist some of which are similar, mutatis mutandis, to those noted above with regard to the other embodiments set forth herein above and herein after. An additional variation of the device might include the complete removal of the outer component 811 and any tube used to hold or control its motion and instead simply allow the device to extend from and rotate within a catheter or other delivery lumen.
FIG. 14 provides a perspective view of a working end of a cutting device 1000 having first and second components 1001 and 1011. The device has an inner cutter 1006 similar to that of cutter 600 of the invention but lacks an outer cutter. Numerous variations of cutter 1000 exist some of which are similar, mutatis mutandis, to those noted above with regard to the other embodiments set forth herein above and herein after. An additional variation of the device might include the complete removal of the outer component 1011 and any tube used to hold or control its motion and instead simply allow the device to extend from and rotate within a catheter or other delivery lumen.
FIG. 15A-15B provide a perspective views of a working end of a cutting device 1100 having first and second components 1101 and 1111. The device is similar to that of cutter 600 except that the central shaft 1106 includes a hollow center 1107 with irrigation apertures 1108. A rotating or non-rotating tube may be connected to this central shaft to provide a flow of irrigation fluid. Numerous variations of cutter 1100 exist some of which are similar, mutatis mutandis, to those noted above with regard to the other embodiments set forth herein above and herein after. Additional variations of the device might include variations on the number, position and orientation of the apertures so that a desired flow volume and flow direction can be obtained.
FIGS. 17A-17C provide various perspective views of a working end of a cutting device 1300 having first and second components 1301, 1311. Component 1301 includes a pair of inner pinch-off cutters 1321, and component 1311 includes a pair of outer pinch-off cutters 1330. In addition, the cutting device includes a third inner component 1331. The device 1300 further includes a central irrigation tube 1306 including passage 1307 and apertures 1308 that forms part of component 1301. Relative rotation between cutters 1321 and 1331 shears tissue extending into the openings between the cutters. Component 1331 provides a tube coupler that is capable of relative rotation relative to the irrigation tube 1306 so that the feed tube can provide fluid for irrigation but need not rotate in unison with the inner cutter. The inside portion of the outer ring of the component 1301 also include inward facing aperture 1318, which may exist solely for fabrication purposes (e.g. release of sacrificial material) or may provide for additional irrigation fluid which may be supplied between a tube connecting to component 1301 and a tube connecting to component 1311. Numerous variations on this embodiment are possible and include those, mutatis mutandis, set forth regard to the various other embodiments set forth herein. Other variations might include a coupling between the irrigation tube and the inner cutting element so that these components can rotate relative to one another.
FIG. 23 illustrates several embodiments of additional cutting devices having rotating parts and a flat distal end. The embodiments shown therein have features that include various combinations or refinement of the features included in the other embodiments presented herein.
The edges 1620 of conical element 1616 and edges 1621 of conical element 1606 can be sharp such that the shearing action from rotation of the edges relative to one another causes the cutter 1600 to drill through material, such as tissue. Further, the edges 1620 and 1621 can have a beveled shape. The beveled edges 1620 can advantageously promote shearing. The beveled edge can have a thickness that is less than 10 microns, such as between 2 and 5 microns, allowing for precise tissue cutting.
The device 1600 also includes pairs of inner and outer cutters elements 1602 and 1612, respectively, extending axially, radially inward from ring-like base structures of components 1601 and 1611, and extending forward azimuthally, as part of components 1601 and 1611 respectively. Component 1601 also includes irrigation channels 1607 leading to irrigation apertures 1608 and 1608′ on the cutting blade and on the ring-like base structure. The cutting device 1600 can be a micro-scale device such that it can be used in small areas of the body that are unreachable by larger devices, such as blood vessels having a diameter of less than 5 mm, such as less than 5 mm, such as less than 3 mm, e.g. less than 1 mm. Moreover, the precision of the build and the minimum feature size can be useful for very precise and specific tissue or material cutting. For example, tissue having a diameter of less than 5 microns, such as between 2 and 5 microns, can be removed. Removing such small samples avoids excessive damage to surrounding tissue.
FIG. 20I provides an example layered device 1600′ as the devices of FIGS. 20A-20H might be formed from a plurality of adhered layers which might be produced in a multi-layer, multi-material fabrication process (e.g. the electrochemical fabrication process described above).
Numerous variations on this embodiment are possible and include those, mutatis mutandis, set forth regard to the various other embodiments set forth herein. Other variations might include inner and/or outer blade configuration that provide for tight fitting blades while minimizing risk of tolerance based collisions by offsetting regions of initial passing (e.g. tips) radially inward (in the case of the inner cutting blades) or outward (in the case of the outer blades) in to ensure smooth passing while providing tightened ring-like base clearances or clearances on portions of the blades that are recessed from the initial contact regions. Variations of the device of this embodiment, like other embodiments described herein, can also provide for an open central region so that a guide wire, imaging device, or other tool or instrument may be moved down the center of the cutting element. The open central region may be defined by the blades themselves or by a ring like structure, with or without, a coupling element through which the central instrument may pass.
FIGS. 22 and 27 show similar devices to device 600, i.e., that include a conical-shaped distal end. Thus, the devices can include many of the same features and advantages as device 600 and may be made using the electrochemical fabrication process described above.
FIGS. 22A-22B provide perspective views of a working end of a cutting device 1800 having first and second components 1801 and 181. Variations of the device 1800 are similar, mutatis mutandis, to those for the other embodiments, noted herein and as with the other embodiments may include features or portions of features found only within the other embodiments themselves. Variations of the device may include a ring-like structure or structures which guide movement for an instrument inserted through the center 1820 of the cutting device so that the instrument cannot inadvertently get caught by the cutting blades themselves.
FIGS. 27A-27C provide various views of an example device 3000 including a working end of an example cutting element 1800 having its inner and outer cutting elements coupled to inner and outer tubes 3001 and 3011 respectively which can be used to rotate the cutting elements or to hold them stationary. FIGS. 27B and 27C provide truncated views of the tubes so that the inner tube may be seen. Variations of this embodiment may make use of the working ends of the other embodiments set forth herein or variations thereof. In other alternatives, the tubes or the working ends themselves may include pivot elements or bendable elements to provide a desired orientation to cutting elements when in use. Further alternatives may include the use of additional tubes or fewer tubes as appropriate. In use, various fluids or vacuum may be applied between the tubes to provide desired lubrication, irrigation, aspiration, drug delivery, or the like.
In some configurations, the cutting devices described herein can be stacked or combined to further cut tissue brought into the tube. Referring to FIGS. 28A-28B, the first device 1800 can include an inner component 1801 and an outer component 1811, which can be designed similar to any of the first and second components described herein. A second device 1800′ can be combined with the first device 1800, such as stacked together axially as shown in FIGS. 28A-28B. The second device 1800′ can include an inner component 1801′ and an outer component 1811′, which can be designed similar to any of the first and second components described herein. Optionally, as shown in FIGS. 28A-28B, the first device 1800 can be a forward-facing cutter, while the second device 1800′ can be a backward-facing cutter relative to the control tubes.
Referring to FIGS. 18, 19, 21, 24, and 26, the cutting devices described herein can be configured to include multiple cutters along the axial and/or radial directions. Having multiple cutters along the axial and/or radial directions can advantageously allow for better shearing of tissue.
FIG. 18 provides a perspective view of a working end of a cutting device 1400 having first and second components 1401, and 1411. Component 1401 includes a pair of inner pinch-off cutters 1421 spaced apart circumferentially, and component 1411 includes a pair of outer pinch-off cutters 1431 spaced apart circumferentially. The inner and outer cutting blades also include interlaced side cutters 1441 that provide for side milling. The side cutters 1441 can each include cutting surfaces 1442 that are parallel to the central axis of the cutter 600. The cutting surfaces 1442 can extend along the same radial plane. The side cutters 1441 can be spaced apart axially. Moreover, each pinch-off cutter 1421 can include a set of side cutters 1441 approximately axially aligned thereto. Further, the side cutters 1441 can each include parallel cutting surfaces 1443 extending perpendicular to the central axis of the cutter 600. The outer component 1411 can include similar cutting surfaces such that the side cutters of the inner and outer components 1401 and 1411 can interlace with one another. The axial thickness of each side cutter 1441 can be less than 100 microns, such as less than 50 microns. The interaction of the side cutters and/or the pinch-off cutters as one or both of the components 1401, 1411 rotates can allow for shearing of tissue. Numerous variations on this embodiment are possible and include those, mutatis mutandis, set forth regard to the various other embodiments set forth herein. Other variations might include different numbers of interlaced elements, different thicknesses of interlaced elements, and different interlacing depths for those elements.
As shown in FIG. 19, a cutting device 1500 can include first and second components 1501 and 1511. The device 1500 includes stacked levels of cutters 1504 on primary cutting elements of both the inner and outer components. The device 1500 further includes side teeth 1514 that provide for retention and shredding of material. The teeth of the inner and outer elements can both extend perpendicular to the central axis of the device and can be located on opposing planes so as to allow shearing when the components 1501, 1511 are rotated relative to one another. The teeth can have an axial thickness of less than 100 microns, such as less than 50 microns, such as less than 10 microns. The device 1500 can also include irrigation apertures on central shaft. Other variations might include different numbers and configurations of stacked cutter primary and secondary cutting teeth.
FIG. 21 provides a perspective view of a working end of a cutting device 1700 having first and second components 1701, and 1711. The first component 1701 includes inner cutting blades 1703 spaced apart circumferentially, while the second component 1711 includes outer cutting blades 1713 spaced apart circumferentially. The inner cutting blades 1703 are provided with outward facing side teeth 1705 that interlace with inward facing side teeth 1715 on the outer cutting blades 1711 to shear tissue as the first and second components rotate with respect to each other. The teeth 1705 can be stacked and spaced apart axially. The teeth 1705 can each include a surface 1706 parallel to the central axis of the device and a surface 1707 perpendicular to the central axis of the device. The surfaces 1706 extending approximately parallel with each other can each be located along a different radial dimension so as to create a conical-shaped distal end of the device. Variations of the device 1700 are similar, mutatis mutandis, to those for the other embodiments, noted herein and as with the other embodiments may include features or portions of features found only within the other embodiments themselves. Variations of the device may include irrigation channels and apertures.
As shown in FIGS. 24A-24B, a cutting device 2000 can include an outer component 2011 and an inner component 2001. The outer component 2011 can include axially-extending cutting elements 2012. The axially-extending cutting elements 2012 can each have a cutting surface 2013 extending parallel to the central axis of the device and a cutting surface 2014 extending perpendicular to the central axis of the device. The axially-extending cutting elements can be spaced apart radially and/or circumferentially. Likewise, the inner component 2001 can include similar axially-extending elements 2002. The axially extending elements 2002 can be spaced apart radially and/or circumferentially. Further, the inner cutting element 2001 can include one or more sloped surfaces 2009 such that the inner cutting elements 2001 can be spaced apart axially. The axially-extending elements of each component can extend along a common axial plane. The interaction of the surfaces of the cutting elements 2012 and 2002 as one or both of the elements 2001, 2011 rotates, can allow for shearing of tissue. In the illustrated embodiment, outer component 2011 has a shaft (not shown) that fits into a bore 2010 formed in inner component 2001.
As shown in FIGS. 26A-26C, a cutting device 2200 can include an inner component 2201 and an outer component 2211. The inner component 2201 can include cutting surfaces 2202 having teeth 2203, while the outer component 2211 can include cutting surfaces 2212 having 2213. Inner component 2201 and outer component 2211 may be rotated with respect to each other so that cutting surfaces 2202 and 2212 can shear tissue extending through intake windows 2216. Other embodiments are possible. For example, the inner cutting element can include multiple cutters extending radially, while the outer cutting element includes multiple cutters extending axially. Alternatively, the inner cutting element can include multiple cutters extending axially while the outer cutter element also includes multiple cutters extending axially.
Further, referring to FIG. 29, the devices described herein, due to their small features sizes and precise build, can advantageously be configured to include ancillary components that extend along the inner central axis and through an opening in the distal end of the device. The cutting device 1900, representing any of the cutting devices described herein, can include including inner and outer cutting elements 1901 and 1911. A hole 2901 can extend along the central axis of the cutting device 1900. As such, an ancillary component 2905 can extend through the cutting device 1900. Referring to FIG. 30A, the ancillary component can be a balloon 3060. Referring to FIG. 30B, the ancillary component can be an umbrella 3062. Referring to FIG. 30C, the ancillary component can be an imaging element 3064, such as a CMOS camera, a fiber optic scope with CCD or CMOS, 2D and 3D capture and display, ultrasound (IVUS), Doppler, or birefringence-insensitive optical coherence tomography (OCT). Referring to FIG. 30D, the ancillary component can be a needle 3066, such as drug delivery needle. Referring to FIG. 30E, the ancillary component can be a longitudinal element 3068 including barbs to, for example, gather tissue and pull it towards the cutting elements or to stabilize tissue during cutting. Referring to FIG. 30F, the ancillary component can be a water jet tube 3072, such as a water jet tube for delivering water to clear clots. Referring to FIG. 30G, the ancillary component can be a guide wire 3074. Additional ancillary components include a device for suction, a device for irrigation, or an energy system to coagulate or cauterize, such as a system providing RF energy, an argon beam, a laser, or a DC current.
In summary, various specific cylindrical cutting device embodiments have been taught herein. These various device embodiments may make use of various elements including: (1) designs are driven with 2 concentric tubes; (2) cutting surfaces that face forward with respect to the longitudinal axis of the tool or instrument; (3) an inside tube is connected to one set of blades; (4) an outside tube is connected to one set of blades; (5) an inside tube is rotated with respect to the outside tubes, making the cutting blades pass one another; (6) in some cases the outside tube can be rotated in either direction at a different rate than the inside tube to expose all blades to the tissue at all azimuthal angles (this allows cutting over the entire front surface of the targeted area); (7) the various device embodiments can be attached to articulating tubes so that the cutting end can be steerable; (8) the various device embodiments can incorporate aspiration to remove the material that has been cut; (9) some embodiments may provide turbine or propeller-like effects which will help material transport away from the targeted area; (10) some embodiments may incorporate irrigation to aid in the material transport; (11) some embodiments may incorporate central imaging; (12) some embodiments may be deliverable via a central guide wire; (13) various embodiments are scalable to different radial sizes from less than one-half millimeter to more than a centimeter; and/or (14) some embodiments may be assisted by one or more proximally located supplement cutters, shredders, or mechanical flow assist devices.
Structural or sacrificial dielectric materials may be incorporated into embodiments of the present invention in a variety of different ways. Such materials may form a third material or higher deposited on selected layers or may form one of the first two materials deposited on some layers. Additional teachings concerning the formation of structures on dielectric substrates and/or the formation of structures that incorporate dielectric materials into the formation process and possibility into the final structures as formed are set forth in a number of patent applications filed Dec. 31, 2003. The first of these filings is U.S. Patent Application No. 60/534,184 which is entitled “Electrochemical Fabrication Methods Incorporating Dielectric Materials and/or Using Dielectric Substrates”. The second of these filings is U.S. Patent Application No. 60/533,932, which is entitled “Electrochemical Fabrication Methods Using Dielectric Substrates”. The third of these filings is U.S. Patent Application No. 60/534,157, which is entitled “Electrochemical Fabrication Methods Incorporating Dielectric Materials”. The fourth of these filings is U.S. Patent Application No. 60/533,891, which is entitled “Methods for Electrochemically Fabricating Structures Incorporating Dielectric Sheets and/or Seed layers That Are Partially Removed Via Planarization”. A fifth such filing is U.S. Patent Application No. 60/533,895, which is entitled “Electrochemical Fabrication Method for Producing Multi-layer Three-Dimensional Structures on a Porous Dielectric”. Additional patent filings that provide teachings concerning incorporation of dielectrics into the EFAB process include U.S. patent application Ser. No. 11/139,262, filed May 26, 2005 by Lockard, et al., and which is entitled “Methods for Electrochemically Fabricating Structures Using Adhered Masks, Incorporating Dielectric Sheets, and/or Seed Layers that are Partially Removed Via Planarization”; and U.S. patent application Ser. No. 11/029,216, filed Jan. 3, 2005 by Cohen, et al., now abandoned, and which is entitled “Electrochemical Fabrication Methods Incorporating Dielectric Materials and/or Using Dielectric Substrates”. These patent filings are each hereby incorporated herein by reference as if set forth in full herein.
Some embodiments may employ diffusion bonding or the like to enhance adhesion between successive layers of material. Various teachings concerning the use of diffusion bonding in electrochemical fabrication processes are set forth in U.S. patent application Ser. No. 10/841,384 which was filed May 7, 2004 by Cohen et al., now abandoned, which is entitled “Method of Electrochemically Fabricating Multilayer Structures Having Improved Interlayer Adhesion” and which is hereby incorporated herein by reference as if set forth in full. This application is hereby incorporated herein by reference as if set forth in full.
Though the embodiments explicitly set forth herein have considered multi-material layers to be formed one after another. In some embodiments, it is possible to form structures on a layer-by-layer basis but to deviate from a strict planar layer on planar layer build up process in favor of a process that interlaces material between the layers. Such alternative build processes are disclosed in U.S. application Ser. No. 10/434,519, filed on May 7, 2003, now U.S. Pat. No. 7,252,861, entitled Methods of and Apparatus for Electrochemically Fabricating Structures Via Interlaced Layers or Via Selective Etching and Filling of Voids. The techniques disclosed in this referenced application may be combined with the techniques and alternatives set forth explicitly herein to derive additional alternative embodiments. In particular, the structural features are still defined on a planar-layer-by-planar-layer basis but material associated with some layers are formed along with material for other layers such that interlacing of deposited material occurs. Such interlacing may lead to reduced structural distortion during formation or improved interlayer adhesion. This patent application is herein incorporated by reference as if set forth in full.
a second annular element at the distal end of the elongate tube and concentric with the first annular element, the second annular element having a flat portion at its distal end perpendicular to the central axis, at least one of the first or second annular elements rotatable about the central axis, the rotation causing the first annular element and the second annular element to pass each other to shear tissue.
2. The tissue cutting device of claim 1 wherein the elongate tube has a diameter less than 5 mm.
3. The tissue cutting device of claim 1 wherein at least one of the first and second annular elements has a tooth having a radial thickness of less than 50 microns.
4. The tissue cutting device of claim 1, wherein the flat portion has an axial thickness of less than 100 microns.
5. The tissue cutting device of claim 1 wherein the first annular element is rotatable about the central axis in an opposite direction from the second annular element.
6. The tissue cutting device of claim 1 wherein the first annular element is rotatable about the central axis in a same direction as the second annular element, the first annular element and the second annular element being configured to be rotated at different speeds.
7. The tissue cutting device of claim 1, further comprising an intake window at the distal end of the elongate tube.
8. The tissue cutting device of claim 1, further comprising a hole extending along the central axis.
9. The tissue cutting device of claim 8, further comprising an ancillary component extending through the hole, the ancillary component comprising an imaging element, a guide wire, a water jet tube, or a barbed device.
10. The tissue cutting device of claim 1, further comprising a third annular element and a fourth annular element, the third and fourth annular elements located between the proximal and distal ends, at least one of the third or fourth annular elements configured to rotate, the rotation causing the third and fourth annular elements to rotate past each other to further shear the tissue.
and wherein edges of the first and second tubular element are beveled to further shear tissue.
12. The tissue cutting device of claim 11 wherein the elongate tube has a diameter less than 5 mm.
13. The tissue cutting device of claim 11 wherein the beveled edges have a thickness less than 10 microns.
14. The tissue cutting device of claim 11 wherein the first annular element is rotatable about the central axis in an opposite direction from the second annular element.
15. The tissue cutting device of claim 11 wherein the first and second elements together form a second conical shape, the second conical shape facing proximally.
16. The tissue cutting device of claim 11 wherein the first annular element is rotatable about the central axis in a same direction as the second annular element, the first annular element and the second annular element being configured to rotate at different speeds.
17. The tissue cutting device of claim 11, further comprising an intake window at the distal end of the elongate tube.
18. The tissue cutting device of claim 11, further comprising a hole extending along the central axis.
19. The tissue cutting device of claim 18, further comprising an ancillary component extending through the hole, the ancillary component comprising an imaging element, a guide wire, a water jet tube, or a barbed device.
20. The tissue cutting device of claim 11, further comprising a third annular element and a fourth annular element, the third and fourth annular elements located between the proximal and distal ends, at least one of the third or fourth annular elements configured to rotate, the rotation causing the third and fourth annular elements to rotate past each other to further shear the tissue.
wherein the first and second annular elements each have an axially-extending cutting surface, the rotation causing the axially-extending surfaces of the first and second annular elements to pass each other to shear tissue, and wherein the first and second annular elements each have a radially-extending cutting surface, rotation causing the axially-extending surfaces of the first and second elements to pass each other to shear tissue, wherein the axially extending cutting surface has an axial length of less than 100 microns.
22. The tissue cutting device of claim 21 further comprising teeth extending along the axially-extending or radially-extending cutting surfaces.
23. The tissue cutting device of claim 21 wherein the elongate tube has a diameter less than 0.5 mm.
24. The tissue cutting device of claim 21 wherein the first annular element is rotatable about the central axis in an opposite direction from the second annular element.
25. The tissue cutting device of claim 21 wherein the first annular element is rotatable about the central axis in a same direction as the second annular element, the first annular element and the second annular element being configured to be rotated at different speeds.
26. The tissue cutting device of claim 21, further comprising an intake window at the distal end of the elongate tube.
27. The tissue cutting device of claim 21 further comprising a hole extending along the central axis.
28. The tissue cutting device of claim 27, further comprising an ancillary component extending through the hole, the ancillary component comprising an imaging element, a guide wire, a water jet tube, or a barbed device.
29. The tissue cutting device of claim 21, further comprising a third annular element and a fourth annular element, the third and fourth annular elements located between the proximal and distal ends, at least one of the third or fourth annular elements configured to rotate, the rotation causing the third and fourth annular elements to rotate past each other to further shear the tissue.
wherein the first and second annular elements each include axially-extending teeth, the teeth having a radial thickness of less than 10 microns, the rotation causing the teeth of the first annular element and the teeth of the second annular element to pass each other to shear tissue.
31. The tissue cutting device of claim 30, wherein the elongate tube has a diameter less than 5 mm.
32. The tissue cutting device of claim 30 wherein the first annular element is rotatable about the central axis in an opposite direction from the second annular element.
33. The tissue cutting device of claim 30 wherein the first annular element is rotatable about the central axis in a same direction as the second annular element, the first annular element and the second annular element being configured to be rotated at different speeds.
34. The tissue cutting device of claim 30 wherein the teeth have a pitch of less than 200 microns.
35. The tissue cutting device of claim 30, further comprising an intake window at the distal end of the elongate tube.
36. The tissue cutting device of claim 30, further comprising a hole extending along the central axis.
37. The tissue cutting device of claim 36, further comprising an ancillary component extending through the hole, the ancillary component comprising an imaging element, a guide wire, a water jet tube, or a barbed device.
38. The tissue cutting device of claim 30, further comprising a third annular element and a fourth annular element, the third and fourth annular elements located between the proximal and distal ends, at least one of the third or fourth annular elements configured to rotate, the rotation causing the third and fourth annular elements to rotate past each other to further shear the tissue.
wherein at least one of the first or second annular elements is rotatable about the central axis, the rotation causing the perpendicular shearing surfaces of the first shearing elements and the perpendicular shearing surfaces of the second shearing elements to pass each other to shear tissue.
40. The tissue cutting device of claim 39, wherein at least some of the perpendicular shearing surfaces of the first shearing elements lie along the same plane.
41. The tissue cutting device of claim 40, wherein the at least some of the perpendicular shearing surfaces are located at the same radial distance from the central axis.
42. The tissue cutting device of claim 39, wherein at least some of the perpendicular shearing surfaces do not lie along the same plane.
43. The tissue cutting device of claim 42, wherein the at least some perpendicular shearing surfaces are located at different radial distances from the central axis.
wherein rotation of one or both of the first and second annular element the causes the parallel shearing surfaces of the first shearing elements and the parallel shearing surfaces of the second shearing elements to pass each other to shear tissue.
45. The tissue cutting device of claim 44, wherein at least some of the parallel shearing surfaces of the first shearing elements lie along the same radial plane.
46. The tissue cutting device of claim 45, wherein the at least some parallel shearing surfaces are spaced apart from each other circumferentially.
47. The tissue cutting device of claim 44, wherein at least some of the parallel shearing surfaces of the first shearing elements are spaced apart from each other radially.
48. The tissue cutting device of claim 39, wherein the elongate tube has a diameter of less than 5 mm.
wherein at least one of the first or second annular elements is rotatable about the central axis, the rotation causing the parallel shearing surfaces of the first shearing elements and the parallel shearing surfaces of the second shearing elements to pass each other to shear tissue.
50. The tissue cutting device of claim 49, wherein at least some of the parallel shearing surfaces of the first shearing elements lie along the same radial plane.
51. The tissue cutting device of claim 50, wherein the at least some of the parallel shearing surfaces are spaced apart from each other axially.
52. The tissue cutting device of claim 51, wherein the at least some of the parallel shearing surfaces are spaced apart from each other circumferentially.
53. The tissue cutting device of claim 49, wherein at least some of the parallel shearing surfaces of the first shearing elements are spaced apart from each other radially.
54. The tissue cutting device of claim 49, wherein the elongate tube has a diameter of less than 5 mm.

References: Application No. 61
 Application No. 60
 Application No. 60
 Application No. 60
 Application No. 60
 Application No. 60