Surgical cutting instruments configured for removal of lesions, polyps and fibroids within the nasal cavity are known. Some configurations may include an elongated inner member rotatably coaxially disposed within a tubular outer member. The distal end of the outer member includes an opening, and the distal end of the inner member includes cutting edges. The proximal ends of the two members may be connected to a handle directly or via a detachable hub. The inner member may be hollow and in communication with an aspiration port so that severed tissue, etc. can be aspirated out through the hollow member. The cutting edges can have any various configurations suitable for the particular type of tissue, such as bone tissue, to be done, with the opening configured to cooperate with the specific cutting edge configuration.
To use such surgical cutting instrument to address such tissues, the opening/cutting edge is advanced to the target surgical site, and the opening positioned adjacent the tissue to be removed. The opening may be repositioned to address tissue which could not be accessed with the instrument in the previous position. Surgical cutting instruments with a fixed opening allow surgeons to cut only in the direction of the fixed opening cutting. To access, cut and remove tissue at various locations, surgeons have to reposition the instrument at various angles; or in some instances, change to other instruments having a more appropriately arranged opening.
It may be desirable to access, cut and remove tissue, such as bone tissue, at various locations without having to reposition or change the surgical instrument. While several different surgical instruments and methods of use have been made for tissue removal within the nasal cavity, it is believed that no one prior to the inventors has made or used the invention described in the appended claims.
While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:
The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.
The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping a handpiece assembly. Thus, an end effector is distal with respect to the more proximal handpiece assembly. It will be further appreciated that, for convenience and clarity, spatial terms such as “upward,” “downward,” “side,” “axial,” and “longitudinal” also are used herein for reference to relative positions and directions. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
It is further understood that any one or more of the teachings, expressions, versions, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, versions, examples, etc. that are described herein. The following-described teachings, expressions, versions, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
Shaft assembly (16) generally includes an outer shaft (28) and an inner cutting member (30) collectively configured to receive and remove tissue from the surgical site. Cutting member (30), which is illustrated as a tube, is disposed within a longitudinally extending lumen (32) of shaft (28). Cutting member (30) is configured to be rotated about a longitudinal axis (42) of shaft assembly (16) at a distal portion. Although shaft assembly (16) is depicted as rigid, all or a portion of shaft assembly (16) may be flexible, with longitudinal axis (42) comprising a series of cross-sectional centers. Cutting member (30) defines a lumen and extends proximally to handle assembly (12) and connects to motorized drive assembly (24), which rotatably drives cutting member (30) relative to shaft (28). In the present example, shaft (28) is formed of polycarbonate and cutting member (30) is formed of stainless steel. Of course, shaft (28) and cutting member (30) may be formed of one or more alternative materials in accordance with the invention described herein. The invention is thus not intended to be unnecessarily limited to manufacture with polycarbonate and stainless steel. While the present example of cutting member (30) is a hollow tube, cutting member (30) is not limited to being tubular and defining its own lumen (32).
Shaft (28) includes a window region (48) having a shaft opening, such as a shaft window opening (50), at a distal portion thereof. Distal portion includes a tubular sidewall (51) that distally terminates in a curved end, such as a generally hemispherical end (52). Shaft window opening (50) extends through tubular sidewall (51) of shaft (28) into lumen (32) and is in fluid communication with the environment surrounding shaft (28). Shaft window opening (50) faces radially outward relative to longitudinal axis (42) such that tissue is configured to be radially received through shaft window opening (50) into a central suction lumen (60) of cutting member (30) in a radially inward direction. Shaft window opening (50) is surrounded by a relatively dull edge (61).
Cutting member (30) includes a cutting window opening (54) at distal portion of cutting member (30). Cutting window opening (54) is configured to longitudinally align with shaft window opening (50) and includes a cutting edge (58) extending therealong. It is noted that less than the entirety of cutting edge (58) may be configured for cutting tissue against an opposing edge (61) of shaft (28). At least a portion of cutting edge (58) is disposed to move adjacent to and across at least a portion of window region (48) when cutting member (30) is rotated or oscillated about longitudinal axis (42). By way of example, as cutting member (30) moves in a clockwise direction, edge (61) of window region (48) provides an opposing surface to cutting edge (58) whereby tissue may be severed to remove a cut tissue portion therefrom. Cutting edge (58) and edge (61) may have any configuration which suitably cooperates with the other to sever tissue, such as a knife edge, a serrated edge, bipolar, monopolar or harmonic energy modality, or laser activated cutting edge.
The extent of movement and position of cutting edge (58) relative to edge (61) is sufficient to separate tissue, whether by severing, tearing or any other mechanism. For example, cutting edge (58) may cyclically move across at least a portion of window region (48). Further clockwise movement of cutting member (30) will advance cutting edge (58) past edge (61), such as results from oscillation about longitudinal axis (42) or from full rotation about longitudinal axis (42).
With continued reference to
Furthermore, surgical cutting instrument (10) may be used in conjunction with an image-guide surgery (IGS) navigation system, medical procedure chair, and displays described alone or in any combination according to the following: U.S. Pat. Pub. No. 2016/0008083, entitled “Guidewire Navigation for Sinuplasty,” published Jan. 14, 2016; U.S. Patent App. No. 62/555,824, entitled “Apparatus to Secure Field Generating Device to Chair,” filed Sep. 8, 2017; U.S. Pat. Pub. No. 2016/0008083, entitled “Guidewire Navigation for Sinuplasty,” published Jan. 14, 2016; U.S. Pat. Pub. No. 2016/0310042, entitled “System and Method to Map Structures of Nasal Cavity,” published Oct. 27, 2016; U.S. Pat. No. 8,702,626, entitled “Guidewires for Performing Image Guided Procedures,” issued Apr. 22, 2014; U.S. Pat. No. 8,320,711, entitled “Anatomical Modeling from a 3-D Image and a Surface Mapping,” issued Nov. 27, 2012; U.S. Pat. No. 8,190,389, entitled “Adapter for Attaching Electromagnetic Image Guidance Components to a Medical Device,” issued May 29, 2012; U.S. Pat. No. 8,123,722, entitled “Devices, Systems and Methods for Treating Disorders of the Ear, Nose and Throat,” issued Feb. 28, 2012; U.S. Pat. No. 7,720,521, entitled “Methods and Devices for Performing Procedures within the Ear, Nose, Throat and Paranasal Sinuses,” issued May 18, 2010; U.S. Pat. Pub. No. 2014/0364725, entitled “Systems and Methods for Performing Image Guided Procedures within the Ear, Nose, Throat and Paranasal Sinuses,” published Dec. 11, 2014; U.S. Pat. Pub. No. 2014/0200444, entitled “Guidewires for Performing Image Guided Procedures,” published Jul. 17, 2014; U.S. Pat. No. 9,198,736, entitled “Adapter for Attaching Electromagnetic Image Guidance Components to a Medical Device,” issued Dec. 1, 2015; U.S. Pat. Pub. No. 2011/0060214, entitled “Systems and Methods for Performing Image Guided Procedures within the Ear, Nose, Throat and Paranasal Sinuses,” published Mar. 10, 2011; U.S. Pat. No. 9,167,961, entitled “Methods and Apparatus for Treating Disorders of the Ear Nose and Throat,” issued Oct. 27, 2015; and U.S. Pat. Pub. No. 2007/0208252, entitled “Systems and Methods for Performing Image Guided Procedures within the Ear, Nose, Throat and Paranasal Sinuses,” published Sep. 6, 2007, the disclosures of each of the these references being incorporated by reference herein.
While surgical cutting instrument (10) is configured to remove a target tissue as discussed above in greater detail, a particular position of such target tissue within the patient will likely vary, to at least some extent, depending on the patient and the tissue identified for removal. For example, in some instances, the target tissue may be positioned along a relatively linearly extending cavity in the patient or, in other instances, may be positioned along more complex, winding cavities within the patient. In order to access target tissue within such complex, winding cavities, the surgeon may attempt to reposition surgical cutting instrument (10) at one or more awkward angles or even discard surgical cutting instrument (10) for a more suitable instrument depending on the circumstance. Thus, manipulating the position of shaft window opening (50) and cutting window opening (54) for greater access to the target tissue generally provides for greater comfort and enhanced outcomes for the patient.
With respect to
Handle assembly (112) has a handle body (118) that may include controls for the operation of surgical cutting instrument (110), or the controls may be located remotely. One such control is an activation control (not shown) configured to selectively power motorized drive assembly (24) via power source (26). Vacuum source (22) fluidly connects to suction port (20) (see
In the present example, shaft (128) is longitudinally and rotationally fixed to handle body (118). Axial adjustment coupling (170) mechanically couples cutting member (130) to a drive output, including a drive output gear (174), such that cutting member (130) rotatably locks to drive output gear (174) while being simultaneously configured to translate relative to drive output gear (174). In turn, cutting member (130) similarly rotates and selectively translates relative to handle body (118) and shaft (128) to accommodate articulation of cutting member (130) relative to articulation of shaft (128) as selectively directed by an articulation input (176) of articulation mechanism (172). While articulation input (176) is shown as a knob in the present example, it will be appreciated that alternative inputs configured to be selectively manipulated by the surgeon may be similarly used.
To this end,
Articulation mechanism (172) includes articulation input (176) connected to a pair of elongate members, such as a pair of cables (178), each connected to a distal end portion (180) of shaft (128). More particularly, cables (178) extend along respective longitudinal channels (182) on angularly opposing sides of a tubular sidewall (151) of shaft (128) about common longitudinal axis (177). Cables (178) are secured to distal end portion (180) of shaft (128) within respective longitudinal channels (182) and proximally extend therefrom into handle body (118) (see
Upon articulation of deflectable shaft assembly (116), a distal shaft end (184) of shaft (128) and a distal member end (186) of cutting member (130) respectively deflect relative to a proximal shaft end (188) of shaft (128) and a proximal member end (190) of cutting member (130). Manipulating articulation input (176) one direction, as shown in
With respect to
As shown in
While rotatably securing drive output gear (174) to proximal member end (190), axial adjustment coupling (170) has a spline coupling (191) that simultaneously allows for longitudinal translation of proximal member end (190) relative to drive output gear (174) for maintaining the predetermined longitudinal distance (D) (see
Axial adjustment coupling (170) of the present example is connected inline with drive output gear (174) and, indeed, a remainder of motorized drive assembly (124), such that axial adjustment coupling (170) is generally distally positioned relative to drive output gear (174). In another example, axial adjustment coupling (170) may be coaxial with common longitudinal axis (177) (see
In another example,
In order to further aid alignment between an inner, cutting member (130) and an outer shaft, another alternative shaft assembly may include a longitudinally elongated shaft window opening (not shown) configured to remain in communication with cutting window opening (154) as cutting member (130) longitudinally moves within outer shaft. Such elongated shaft window opening (not shown) longitudinally extends further than shaft window opening (50), discussed above, while cutting window opening (154) may remain the same. The additional elongation of elongated shaft window opening (not shown) is sized to accommodate the longitudinal movement of cutting window opening (154) to maintain consistent communication therethrough in any of the configurations shown in
In use, with respect to
With respect to
Once shaft window opening (50) accesses the target tissue, the surgeon selectively powers motorized drive assembly (124) to transmit torque from drive output gear (174) and through axial adjustment coupling (170) to rotatably drive cutting member (130) to cut and remove the target tissue against cutting edge (58) (see
The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.
A surgical instrument, comprising: (a) a shaft configured to articulate from a first configuration toward a first articulated configuration, including: (i) a distal shaft end, (ii) a proximal shaft end, (iii) a shaft sidewall extending from the distal shaft end to the proximal shaft end and configured to move the distal shaft end relative to the proximal shaft, and (iv) a shaft window opening extending through the shaft sidewall; (b) a cutting member disposed within the shaft and configured to cyclically move relative to the shaft, wherein the cutting member is further configured to articulate within the shaft from the first configuration toward the second configuration, including: (i) a distal member end, (ii) a proximal member end, (iii) a member sidewall extending from the distal member end to the proximal member end and configured to move the distal member end relative to the proximal member end, (iv) a cutting window opening extending through the member sidewall and configured to align with the shaft window during cyclical movement relative thereto and receive a tissue for cutting, and (c) an axial adjustment coupling longitudinally securing the shaft relative to the cutting member and configured to longitudinally move the proximal member end relative to the proximal shaft end while articulating the shaft and the cutting member from the first configuration toward the second configuration to inhibit movement of the distal member end relative to the distal shaft end for maintaining alignment between the shaft window opening and the cutting window opening.
The surgical instrument of Example 1, wherein the cutting member further includes a suction lumen extending longitudinally therethrough and in fluid communication with the cutting window opening, wherein the cutting window opening is configured to align with the shaft opening during cyclical movement relative thereto such that the cutting window opening and the shaft opening are in fluid communication for suctioning the tissue therethrough.
The surgical instrument of any one or more of Examples 1 through 2, wherein the axial adjustment coupling longitudinally biases the distal member end toward the distal shaft end.
The surgical instrument of any one or more of Examples 1 through 3, further comprising at least a portion of a motorized drive assembly, wherein the axial adjustment coupling rotatably secures the cutting member relative to the at least the portion of the motorized drive assembly to inhibit relative rotation therebetween.
The surgical instrument of any one or more of Examples 1 through 4, wherein the shaft is configured to articulate from the first configuration toward a third configuration, and wherein the cutting member is further configured to articulate within the shaft from the first configuration toward the third configuration.
The surgical instrument of Example 5, wherein the first configuration is a first straight configuration, wherein the second configuration is a first articulated configuration, and wherein the third configuration is a second articulated configuration, and wherein the second articulated configuration is bent opposite from the first articulated configuration.
The surgical instrument of any one or more of Examples 1 through 6, further comprising an articulation mechanism operatively connected to the shaft and the cutting member and configured to articulate the shaft and the cutting member from the first configuration toward the second configuration.
The surgical instrument of Example 7, wherein the articulation mechanism includes an elongate member connected to the shaft, and wherein the elongate member is configured to be pulled and thereby articulate the shaft from the first configuration toward the second configuration.
The surgical instrument of Example 8, wherein the shaft sidewall is configured to engage the member sidewall while moving from the first configuration toward the second configuration to urge the cutting member from the first configuration toward the second configuration.
The surgical instrument of Example 8, further comprising a body assembly having the shaft and the cutting member distally extending therefrom, wherein the articulation mechanism further includes an articulation input positioned on the body assembly and operatively connected to the elongate member, wherein the articulation input is configured to selectively urge the elongate member to direct the shaft from the first configuration toward the second configuration.
The surgical instrument of any one or more of Examples 1 through 10, wherein at least a portion of the shaft configured to articulate is formed from a flexible material.
The surgical instrument of any one or more of Examples 1 through 11, wherein at least a portion of the shaft configured to articulate has a plurality of gaps positioned longitudinally therealong, wherein the plurality of gaps are respectively configured to at least partially close together in the second configuration.
The surgical instrument of any one or more of Examples 1 through 12, further comprising a body assembly including a motorized drive assembly, wherein the shaft and the cutting member distally extend from the body assembly.
The surgical instrument of Example 13, wherein the motorized drive assembly includes a drive output member, and wherein the axial adjustment coupling rotatably secures the cutting member relative to the drive output member to inhibit relative rotation therebetween.
The surgical instrument of any one or more of Examples 1 through 14, wherein the shaft is a shaft tube and the cutting member is a cutting member tube.
A surgical instrument, comprising: (a) a body assembly including a motorized drive assembly having a drive output member; (b) a shaft distally extending from the body assembly and configured to articulate from a straight configuration toward an articulated configuration, including: (i) a distal shaft end, (ii) a proximal shaft end, (iii) a shaft sidewall extending from the distal shaft end to the proximal shaft end and configured to move the distal shaft end relative to the proximal shaft, and (iv) a shaft window opening extending through the shaft sidewall; (c) a cutting member disposed within the shaft and configured to cyclically move relative to the shaft, wherein the cutting member is further configured to articulate within the shaft from the straight configuration toward the articulated configuration, including: (i) a distal member end, (ii) a proximal member end, (iii) a member sidewall extending from the distal member end to the proximal member end and configured to move the distal member end relative to the proximal member end, (iv) a cutting window opening extending through the member sidewall and configured to align with the shaft window during cyclical movement relative thereto and receive a tissue for cutting, and (d) an axial adjustment coupling longitudinally securing the shaft relative to the cutting member and rotatably securing the cutting member relative to the drive output member, wherein the axial adjustment coupling biases the distal member end toward the distal shaft end and is configured to longitudinally move the proximal member end relative to the proximal shaft end while articulating the shaft and the cutting member from the straight configuration toward the articulated configuration to inhibit movement of the distal member end relative to the distal shaft end for maintaining alignment between the shaft window opening and the cutting window opening.
The surgical instrument of Example 16, further comprising an articulation mechanism having an elongate member connected to the shaft, and wherein the elongate member is configured to be pulled and thereby articulate the shaft from the straight configuration toward the articulated configuration.
A method of accessing a tissue with a surgical instrument, wherein the surgical instrument includes a shaft extending from a distal shaft end to a proximal shaft end and a cutting member extending from a distal member end to a proximal member end, the cutting member disposed within the shaft and configured to cyclically move relative to the shaft, wherein the shaft and the cutting member are configured to articulate from a straight configuration toward an articulated configuration, the method comprising: (a) articulating the shaft and the cutting member from the straight configuration toward the articulated configuration; (b) longitudinally moving the proximal member end relative to the proximal shaft end with an axial adjustment coupling thereby maintaining a longitudinal position of the distal member end relative to the distal shaft end throughout articulation from the straight configuration toward the articulated configuration; and (c) accessing the tissue with the shaft and the cutting member in the articulated configuration.
The method of Example 18, further comprising biasing the distal member end of the cutting member toward the distal shaft end of the shaft.
The method of any one or more of Examples 18 through 19, further comprising rotating the cutting member relative to the shaft within the shaft while inhibiting rotation of the cutting member relative to a drive output member of a motorized drive assembly with the axial adjustment coupling connected therebetween.
It should be understood that any of the examples described herein may include various other features in addition to or in lieu of those described above. By way of example only, any of the examples described herein may also include one or more of the various features disclosed in any of the various references that are incorporated by reference herein.
It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein. The above-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
Versions of the devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
By way of example only, versions described herein may be processed before surgery. First, a new or used instrument may be obtained and if necessary cleaned. The instrument may then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the instrument and in the container. The sterilized instrument may then be stored in the sterile container. The sealed container may keep the instrument sterile until it is opened in a surgical facility. A device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.
Having shown and described various versions of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, versions, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.
This application claims priority to U.S. Provisional Pat. App. No. 62/775,135, entitled “Bi-Directional Articulating Surgical Shaver,” filed Dec. 4, 2019, the disclosure of which is incorporated by reference herein.
Number | Date | Country | |
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62775135 | Dec 2018 | US |
Number | Date | Country | |
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Parent | 16666484 | Oct 2019 | US |
Child | 18218712 | US |