Powered laryngeal cutting blade

[0002] This application is a continuation application of prior U.S. patent application Ser. No. 09/392,797, filed Sep. 9, 1999 now abandoned, which claims priority to U.S. provisional application Ser. No. 60/099,563, filed Sep. 9, 1998, the entire disclosures of which are incorporated herein by reference.

[0003] The present invention relates generally to instruments and methods for removing laryngeal lesions and, more particularly, to a surgical cutting instrument in the form of a powered shaver having a blade with an elongate inner member rotatably disposed within an elongate outer member having a cutting window at a distal end configured to permit laryngeal use including debulking of large, firm lesions and delicate shaving of superficial lesions directly on the vocal folds within the larynx.

[0004] Treatment for the removal of laryngeal lesions has progressed from cold steel techniques to the use of the CO₂laser and KTP fiber directed laser. While the laser has become the standard treatment, there remain concerns such as airway fire and laser plume. Additionally, the use of lasers in removing laryngeal lesions can result in laser burn and post procedure edema.

[0005] Accordingly, it is an object of the present invention to provide an alternative treatment for the removal of laryngeal lesions that is safer, more accurate, and faster than laser tissue vaporization.

[0006] It is another object of the present invention to minimize post procedure edema by confining tissue injury to the superficial mucosa only.

[0007] Yet another object of the present invention is to reduce post operative pain and to speed recovery of the voice following removal of laryngeal lesions.

[0008] It is still another object of the present invention to address the fixed operating radius of the laryngoscope in laryngeal procedures by forming the distal tip of a powered shaver blade driven by a handpiece with an angle such that the radius of surgical access is increased to provide surgeons with the best view of the working tip plus enhanced access to lateral structures, the anterior commissure or the undersurface of the vocal folds.

[0009] Some of the advantages of the present invention over the prior art are that concerns such as laser burn, airway fire and laser plume are eliminated, post procedure edema is minimized, and post operative pain is reduced. In addition, equipment costs, set up and surgical time for the shaver are dramatically reduced versus the laser.

[0010] These and other objects and advantages can be accomplished individually or in combination by use of a powered shaver having a blade assembly in accordance with the present invention.

[0011] Other objects and advantages of the present invention will become apparent from the following description of the preferred embodiments taken in conjunction with the accompanying drawings, wherein like parts in each of the several figures are identified by the same reference numerals or by reference numerals having the same last two digits.

[0012] FIG. 1 is a side view, broken longitudinally, of a laryngeal blade according to the present invention.

[0013] FIG. 2 is a fragmentary rear view of the laryngeal blade shown in FIG. 1

[0014] FIG. 3 is a side view, straightened and broken longitudinally, of the laryngeal blade shown in FIG. 1.

[0015] FIG. 4 is an enlarged fragmentary view of the distal end of the outer blade member.

[0016] FIG. 5 is a front view of the outer blade member.

[0017] FIG. 6 is a fragmentary top view of the distal end of the outer blade member.

[0018] FIGS. 7-10 are sectional views taken through lines 7—7, 8—8, 9—9 and 10—10, respectively, in FIG. 4.

[0019] FIG. 11 is a side view, broken longitudinally, of a modification of an outer blade member according to the present invention.

[0020] FIG. 12 is a fragmentary top view of the modified outer blade member shown in FIG. 11.

[0021] FIG. 13 is a bottom view of the modified outer blade member shown in FIG. 11.

[0022] FIG. 14 is an enlarged fragmentary view of the distal end of the modified outer blade member shown in FIG. 11.

[0023] FIG. 15 is a front view of the modified outer blade member shown in FIG. 11.

[0024] FIG. 16 is a side view, broken longitudinally, of another modification of an outer blade member according to the present invention.

[0025] FIG. 17 is a fragmentary top view of the modified outer blade member shown in FIG. 16.

[0026] FIG. 18 is a bottom view, broken longitudinally, of the modified outer blade member shown in FIG. 16.

[0027] FIG. 19 is a side view, broken longitudinally, of an inner blade member or assembly for the laryngeal blade according to the present invention.

[0028] FIG. 20 is a side view, broken longitudinally, of a cutting tip at the distal end of the inner blade member.

[0029] FIG. 21 is a top view of the cutting tip shown in FIG. 20.

[0030] FIG. 22 is an enlarged fragmentary side view of the cutting tip shown in FIG. 20.

[0031] FIG. 23 is a front view of the cutting tip shown in FIG. 22.

[0032] FIG. 24 is a sectional view taken through line 24—24 in FIG. 22.

[0033] FIG. 25 is a side view, broken longitudinally, of a modification of a cutting tip or cutter for use with the laryngeal blade according to the present invention.

[0034] FIG. 26 is a top view of the modified cutter shown in FIG. 25.

[0035] FIG. 27 is an enlarged fragmentary side view of the cutter shown in FIG. 25.

[0036] FIG. 28 is a front view of the cutter shown in FIG. 27.

[0037] FIG. 29 is a side view, broken longitudinally, of yet another modification of a cutter for use with the laryngeal blade according to the present invention.

[0038] FIG. 30 is a top view of the modified cutter shown in FIG. 29.

[0039] FIG. 31 is an enlarged fragmentary side view of the cutter shown in FIG. 29.

[0040] FIG. 32 is a front view of the cutter shown in FIG. 31.

[0041] FIG. 33 is a modified laryngeal blade according to the present invention.

[0042] FIG. 34 is a side view, broken longitudinally, of the outer blade member shown in FIG. 33.

[0043] FIG. 35 is a bottom view, broken longitudinally, of the outer blade member shown in FIG. 34.

[0044] FIG. 36 is a fragmentary top view of the outer blade member shown in FIG. 34.

[0045] FIG. 37 is an enlarged fragmentary view of the distal end of the outer blade member shown in FIG. 34.

[0046] FIG. 38 is a front view of the outer blade member shown in FIG. 37.

[0047] FIG. 39 is an enlarged fragmentary side view of the distal end of the outer blade member.

[0048] FIG. 40 is a side view, broken longitudinally, of an inner blade member for use with the laryngeal blade illustrated in FIG. 33.

[0049] FIG. 41 is a side view of a cutting tip or cutter for use with the laryngeal blade according to the present invention.

[0050] FIG. 42 is a front view of the cutter shown in FIG. 41.

[0051] FIG. 43 is a top view of the cutter shown in FIG. 41.

[0052] FIG. 44 is a sectional view taken through line 44—44 in FIG. 41.

[0053] FIG. 45 is a perspective view of a modified cutter for use with the laryngeal blade according to the present invention.

[0054] FIG. 46 is a side view of the modified cutter shown in FIG. 45.

[0055] FIG. 47 is a front view of the cutter shown in FIG. 46.

[0056] FIG. 48 is a top view of the cutter shown in FIG. 46.

[0057] FIG. 49 is another view of the cutter shown in FIG. 46.

[0058] FIGS. 50 and 51 illustrate use of the laryngeal blade according to the present invention for removal of papilloma from the vocal fold.

[0059] FIG. 52 illustrates use of the laryngeal blade according to the present invention for removal of papilloma from the anterior commissure.

[0060] FIGS. 53 and 54 illustrate use of the laryngeal blade according to the present invention for removal of lesions located on the undersurface of the vocal fold.

[0061] FIGS. 55 and 56 illustrate use of the laryngeal blade according to the present invention for removal of vocal fold polyps.

[0062] FIG. 57 illustrates use of the laryngeal blade according to the present invention for delicate sculpting of edges after removal of an airway tumor using an aggressive toothed blade.

[0063] A powered laryngeal cutting blade 10 according to the present invention is illustrated in FIGS. 1-3 and can be driven by any suitable handpiece such as the STRAIGHTSHOT marketed by Xomed Surgical Products, Inc. and shown in U.S. Pat. No. 5,916,231 to Bays, the disclosure of which is incorporated herein by reference. The blade 10 includes an outer blade member or assembly 12 and a hollow inner blade member assembly 14 rotatably received within the outer blade member. Outer blade member 12 includes a hub 16 with an irrigation port or coupling 17 extending angularly therefrom and an outer tubular member or sleeve 18 having a proximal portion 20 of straight configuration extending distally from the hub to a proximal bend 22 connecting the proximal portion with a distal portion 24 oriented at an angle θ of about 45° relative to the longitudinal axis 26 of the proximal portion. The proximal bend 22 is closer to the proximal portion 20 than to the distal end 28 to provide desired spacing of the distal end from the proximal portion. Angled straight distal portion 24 of the outer tubular member extends downwardly from bend 22, looking at FIG. 1, a distance greater than the distance between bend 22 and the proximal portion and portion 24 extends to a rounded distal end 28 having an opening facing upwardly, away from the center of curvature of the bend, to define a cutting port or window 30. Dependent upon the anatomical situation and requirements, the window 30 can face in any desired direction (i.e. also downwardly or sidewards) and the outer blade member 12 can have multiple curves or bends, such as 22, along the length thereof.

[0064] As best seen in FIGS. 4-10, cutting port or window 30 is beveled and includes a plurality of teeth 32 along longitudinal sides thereof with an outer surface or edge 34 of the window being dull or blunt and an inner surface or edge 36 of the window being sharp. Four teeth 32 are shown on each side, however, any number of teeth can be used.

[0065] FIGS. 11-15 illustrate a modification of the outer assembly 12 to provide a smooth profile (as compared with the above described toothed laryngeal blade) wherein the outer. tubular member includes a necked distal portion 38 extending to a distal end having and a beveled circular cutting port or window 30 similar to that described above in that the inner surface or edge 36 is sharp but without any teeth. The necked distal portion, which is joined to the proximal portion, as an outer or external cross-sectional diameter smaller than the outer or external cross-sectional diameter of the proximal portion.

[0066] FIGS. 16-18 illustrate another modification of the outer assembly 12 similar to that shown in FIGS. 11-15 but without a necked portion at a distal end.

[0067] FIGS. 19-24 illustrate an inner assembly 14 for the laryngeal blade according to the present invention, the inner assembly including a hub 40, a drive shaft 42 extending distally from the hub to a flexible coupling 44, and a cutting tip or cutter 46 extending distally from the flexible coupling. Cutting tip 46 includes a distal opening 48 defined by a peripheral edge with teeth 50 having a blunt inner surface or edge 52 and a sharp outer surface or edge 54. The distal opening communicates with a lumen defined by the inner assembly to permit tissue evacuation when the blade is connected with a source of suction. The inner assembly 14 has a size to rotate within the outer blade member 14 with sufficient annular space for irrigating fluid to pass between the inner and outer members from port 17 to the cutting tip via a flat 49 adjacent and aligned with opening 48 in order to prevent clogging of cut tissue in the lumen of the inner blade. The cut tissue is aspirated from the surgical site in a straight path through hub 40 to also prevent clogging and can be drawn through a STRAIGHTSHOT handpiece in a straight path.

[0068] FIGS. 25-28 illustrate a modification of a cutting tip 46 similar to that described above but with a necked distal portion 56 and a beveled circular distal opening or cutting tip 48 without any teeth. As shown in FIGS. 25 and 26, the necked distal portion 56 is joined to a proximal portion of the cutting tip and has an outer or external cross-sectional diameter smaller than the outer or external cross-sectional diameter of the proximal portion of the cutting tip. As also shown in FIGS. 25 and 26, the cutting tip 46 includes an intermediate portion joining the distal and proximal portions of the cutting tip, and the intermediate portion has an outer or external cross-sectional diameter smaller than the outer diameter of the proximal portion of the cutting tip and larger than the outer diameter of the distal portion of the cutting tip.

[0069] FIGS. 29-32 illustrate another modification of a cutting tip 46 similar to that shown in FIGS. 25-28 but with an enlarged distal portion 56 of larger diameter than the proximal portion of the cutting tip.

[0070] A modification of a laryngeal blade according to the present invention is shown in FIG. 33 at 10. The modified blade 10 is similar to that shown in FIG. 1 but with a distal bend 23 forming an angled distal portion 58 of relatively short length (e.g., about 0.425 inch) oriented at an angle of about 15° relative to distal portion 24 such that bend 23 is opposite the direction of bend 22 and the distal portion extends in the upward direction looking at FIG. 33 or any other desired direction as noted above dependent on anatomy. The angular orientation allows the surgeon the best view of the working tip plus enhanced access to lateral structures, the anterior commissure, the posterior commissure or the undersurface of the vocal folds.

[0071] FIGS. 34-39 illustrate further details of the outer assembly 12 of laryngeal blade 10 shown in FIG. 33. Like the blade 10 shown in FIG. 1, window 30 of the blade shown in FIG. 33 is sharp along an inner surface or edge 36 and blunt or dull along an outer surface or edge 34. The window can be formed with teeth 32 as shown in FIGS. 34-39, or without teeth (e.g., in the ways described above for the blade shown in FIG. 1). FIG. 37 illustrates the cutting teeth extending upwardly at an angle of 13° from a distal end to a proximal end of the cutting window. FIG. 37 also illustrates the cutting teeth as having rearward surfaces angularly joined to forward surfaces thereof, with each of the rearward surfaces being angularly joined to a proximally adjacent forward surface at an angle of 90°. FIG. 39 illustrates the forward surfaces disposed at an angle of 136° to a central longitudinal axis of the outer tubular member

[0072] Inner assembly 14 for the modified blade is similar to that described above but with a pair of flexible couplings 44 longitudinally spaced as shown in FIG. 40 to correspond to the bends in outer tubular member 44 of the modified blade. FIGS. 41-49 illustrate exemplary cutting tips 46 which can be used with the inner assembly 14. FIG. 41 illustrates the cutting teeth as having proximal surfaces angularly joined to distal surfaces thereof, with each of the proximal surfaces being angularly joined to a proximally adjacent distal surface at an angle of 90°. FIG. 44 illustrates the blunt inner edge 52 joined to the sharp outer edge 54 by a surface disposed at an angle of 46°.

[0073] In use, general anaesthesia is typically induced and the airway secured by endotracheal tube (ETT) intubation or tracheotomy, if indicated. Size of the endotracheal tube will vary depending on airway conditions (presence of stenosis) and intubation technique. In adults, a small, cuffed 5.0 mm or 5.5 mm ETT is adequate for ventilation and allows access for surgical instrumentation. With stenotic lesions, smaller cuffless ETTs may be required. In this situation, the laryngoscope may accommodate powered instrumentation, a rigid telescope, and the ETT, allowing for uninterrupted surgery.

[0074] The laryngoscope is positioned to allow access to the anatomy to be excised with the powered shaver 10. Access to the anterior commissure and subglottic region may be accomplished using an anterior commissure laryngoscope. Visualization can be enhanced using 0° or 30° rigid telescopes and conventional video imaging systems. Console settings for the powered handpiece should preferably be set on “oscillate” mode with a maximum speed set at about 1000 rpms for superficial lesions or those located near or on the vocal folds. Use of “variable” mode of foot switch operation is preferred as it allows for more controlled excision with slow, single revolutions when needed. The laryngeal blade is then securely attached to the powered handpiece. Irrigation (e.g., a 1000 cc or 3000 cc bag at 6 foot elevation) is preferably used with the blade and allowed to flow continuously throughout the procedure to prevent clogging. Wall suction levels may be adjusted to provide enough vacuum to allow the blade to remove tissue at an efficient rate (e.g., 150 mm to 180 mm Hg). Use of an in-line tissue trap is desirable to capture specimens for pathology.

[0075] The laryngeal shaver blade 10 can be utilized for a number of procedures. In FIGS. 50 and 51, the laryngeal blade 10 is shown in use, along with a laryngoscope or endoscope 11, for delicate removal of papilloma from the vocal fold. Oscillation speeds of between about 60 and about 1000 rpm are believed to offer the most precise result and, for the most precise excisions, tissue can be pulled into the opening and with light pressure on the variable foot switch amputated with single blade revolutions. With the window configuration of the present invention, discrete lesions can be accurately removed with trauma limited to the superficial mucosa. For greatest precision when removing papilloma from the anterior commissure, endoscopic visualization with a 30° endoscope is recommended as shown in FIG. 52.

[0076] The angled-tip design of the laryngeal blade 10 shown in FIG. 33 allows excellent access for removal of lesions located on the under surface of the vocal fold as shown in FIGS. 53 and 54. With an oblique endoscope and/or aid of suction to elevate the vocal fold, delicate excision of pathology can be achieved.

[0077] Vocal fold polyps can be quickly and precisely removed without tearing or trauma to peripheral tissues as shown in FIGS. 55 and 56. After debulking airway tumors using the aggressive toothed laryngeal blades shown in FIGS. 1-10, 19-24 and 33-44, edges can be more delicately sculpted with the smooth laryngeal blades shown in FIGS. 11-18, 25-32 and 45-49.

[0078] The toothed laryngeal blades according to the present invention are particularly effective for debulking of large, firm lesions, such as exophytic or fibrous lesions, airway tumors, granulation tissue, tracheal lesions and metastatic tumors. The smooth laryngeal blades according to the present invention are particularly effective for delicate shaving of superficial lesions off the vocal folds, such as papilloma, without tearing or trauma and after removal of bulk mass by the toothed laryngeal blades, for sculpting edges.

[0079] The tubular portions of the blade can be formed of any suitable materials and can have any suitable dimensions. For example, the tubular portions can be made of stainless steel with the outer tube being about 0.156 in diameter and about 11.0 inches long, the inner tube or drive shaft being rotatable within the outer tube with sufficient space for irrigating fluid to pass therebetween.

[0080] Inasmuch as the present invention is subject to many variations, modifications, and changes in detail, it is intended that all subject matter discussed above or shown in the accompanying drawings be interpreted as illustrative only and not be taken in a limiting sense.