Surgical cutting accessories with malleable tube assemblies

Abstract

A surgical instrument cutting accessory comprises a tube assembly (38), the tube assembly comprising an outer tube having at least one slotted region (50) configured to be bent into a molded shape and to maintain the tube assembly in the molded shape. The slotted region may be a proximal slotted region separated from a distal slotted region to define a rigid intermediate segment and a rigid distal segment of the tube assembly. The proximal slotted region or the distal slotted region may have different rotational directions. The spacing between adjacent slots in the proximal slotted region may differ from the spacing between adjacent slots in the distal slotted region. The tube assembly can be molded with an initial pre-bend at a predetermined angle and can be configured to be bent to a predetermined angle. The tube assembly may be a two-tube configuration or a three-tube configuration.

Description

Technical Field

[0001] [Claiming Priority] This application claims the priority and all benefits of U.S. Provisional Patent Application No. 63 / 521,423, filed on June 16, 2023, the entire content of which is incorporated herein by reference and made a part of this specification.

Background Art

[0002] Powered surgical cutting instruments are common in modern operating rooms and are used to excise substantially all tissue types at substantially all anatomical locations. The form of the cutting instrument can be based in part on the accessibility of the tissue to be excised. In the case of orthopedic procedures, for example, the target tissue can be accessed in a relatively straightforward manner, and the cutting instrument can include a straight shaft for on-axis resection. In the case of more delicate procedures involving anatomical structures with difficult access, such as in otolaryngology (ENT), the shaft can include at least one bend. The selection of the angle or curvature of the bend(s) is typically made from a catalog of cutting accessories, so a given bend angle(s) may not be optimal based on the patient's specific anatomical structure or surgical needs. Further, since the shaft is rigid, the surgeon cannot make on-site adjustments during the surgical procedure.

[0003] Patent Document 1 to Edwards, published on February 28, 2013, discloses a tubular malleable segment on the shaft of a surgical instrument. Both ends of the tubular malleable segment are coupled to an outer tube in which an inner tube rotates. The tubular malleable segment can only slightly adjust the malleability of the bend. Further, since the tubular malleable segment relies on a ductile material, it loses circularity with bending, increasing the likelihood of torsion or other damage to the shaft and the likelihood of premature failure of the surgical instrument. Furthermore, the tubular malleable segment may apply a bending moment to the inner tube due to the compliance of the ductile material. [Prior art documents] [Patent Documents]

[0004] [Patent Document 1] U.S. Patent Application Publication No. 2013 / 0053830 [Overview of the Initiative]

[0005] This disclosure relates to a cutting accessory for surgical instruments that provides adjustment of the malleability of a tube assembly. The tube assembly may comprise one or more malleable regions. The malleable region(s) may be formed by a row of slots defining at least one malleable spine (malleable dorsal ridge) between them. The slots may be formed with several properties to impart desired flexibility, allowing the user to bend the tube assembly into a molded shape, and to have shape retention to maintain the tube assembly in the molded shape. Slot properties may include, among others, the kerf (cut width), segment length, non-cutting angle, cutting angle, upper slot angle, and lower slot angle. The slot properties or cutting pattern may be specifically designed to result in a larger bending angle and improved component life while maintaining the circularity of the outer tube. The maximum bending angle achievable with the cutting accessory is greater than that of known devices, and similarly, steeper curvatures are achievable.

[0006] There are several advantages to cutting accessories. Firstly, the bending angle imparted to the tube assembly can be modified and specifically adjusted to suit the anatomical structure being accessed. In other words, multiple procedural approaches can be provided with a single device, reducing equipment costs and environmental waste. The bending(s) imparted to the tube assembly are particularly suitable for endoscopic procedures involving anatomical structures that are difficult to access, such as ENT procedures with transnasal or transoral approaches. One, two, three, four, or more bending(s) can be realized, and the proximal and distal malleable regions, which are spaced apart from each other, can facilitate bringing the bending(s) close to the desired axial position(s) along the tube assembly. The bending(s) can be removed for subsequent steps in the surgical procedure without affecting the performance of the surgical instrument.

[0007] In a particular embodiment, the cutting accessory comprises an outer hub, and the drive hub is rotatably disposed within the outer hub. The tube assembly extends distally from the outer hub and comprises an outer tube, an inner tube, and optionally an intermediate tube. The outer tube is coupled to the outer hub, the intermediate tube is coaxially disposed within the outer tube, and the inner tube is coaxially disposed within the intermediate tube and coupled to the drive hub. The cutting end of the tube assembly may be a microdebrider or bur, or other powered or manual cutting instrument, such as a curette, rasp, blade tip, trephine, brush, screwdriver, endoscope camera, light assembly, etc.

[0008] The outer tube comprises at least one slotted region in which the slot rows form at least one malleable spine. The inner tube comprises at least one flexible region corresponding at least to the axial position of the slotted region(s). In embodiments where an intermediate tube is present, the intermediate tube also comprises at least one flexible region corresponding at least to the axial position of the slotted region(s) and the axial position of the flexible region(s) of the inner tube. The slotted region may comprise an upper slotted region and a lower slotted region separated from the upper slotted region by a malleable spine. The bending properties of the tube assembly are also based on the segment length, which can be the same or varied along the length of the slotted region. The non-cutting angle and cutting angle can be selectively designed to provide a desired combination of flexibility, allowing the user to bend the tube assembly into a shape-retaining molded form, and maintaining the molded form after bending. It is assumed that the cutting angle of the upper slotted region may differ from the cutting angle of the lower slotted region, and vice versa. The non-cutting angle associated with one of the malleable spines can be different from that of the other malleable spine, in which case the slot can be radially offset. Finally, by varying the upper slot angle and / or lower slot angle, more complex shapes can be provided to achieve a desired combination of flexibility and shape retention.

[0009] The slotted region may extend distally to the outer hub along 25 percent, 50 percent, 75 percent, 90 percent, or more of the length of the tube assembly. Alternatively, two or more slotted regions may be present. The proximal slotted region may be separated from the distal slotted region. One or both of the proximal and distal slotted regions may have any of the slot characteristics described throughout this disclosure. The slot characteristics of the proximal slotted region may be the same as or different from those of the distal slotted region. The length of the proximal slotted region may be the same as or different from the length of the distal slotted region.

[0010] In certain embodiments, it may be desirable to have two or more bends, and the cut ends may be offset in at least two directions relative to a straight tube assembly. The proximal slotted region may be oriented at a proximal radial angle, and the distal slotted region may be oriented at a distal radial angle different from the proximal radial angle. In certain embodiments, the spacing between slots varies along the length of the outer tube. For example, the spacing between adjacent slots in a row of slots in the proximal slotted region is greater than the spacing between adjacent slots in a row of slots in the distal slotted region. In certain embodiments, the tube assembly may be formed with an initial pre-bend. In certain embodiments, the tube assembly may have an initial fixed pre-bend, and the slotted region(s) may be positioned distal to the initial fixed pre-bend.

[0011] In a particular embodiment, the intermediate tube facilitates the rotational adjustment of the cutting window. The cutting accessory may include an actuator coupled to the outer hub and operably coupled to the intermediate tube. This coupling can be facilitated by appropriate gearing within the outer hub, such as bevel gearing, worm gearing, etc. The input to the actuator is configured to rotate the intermediate tube relative to the outer and inner tubes. The rotation of the intermediate tube causes the cutting window to rotate around its longitudinal axis.

[0012] In a particular embodiment, the cutting accessory comprises a sensor coupled to a tube assembly and positioned distal to the malleable region. The sensor may be an electromagnetic (EM) sensor or other suitable tracking technique that does not require a line of sight. Leads couple the sensor to an electronic subcomponent within an outer hub. Leads may extend proximal to the sensor. Leads may be twisted wire pairs to reduce interference from the sensor. The sensor and leads may be secured to the outer tube by a sheath.

[0013] Accordingly, according to a first aspect of the present disclosure, the cutting accessory comprises an outer hub configured to be coupled to a handpiece. A drive hub is rotatably located within the outer hub and configured to be operably coupled to a motor. The tube assembly comprises an outer tube coupled to the outer hub and extending distally from the outer hub; an intermediate tube coaxially located within the outer tube and extending distally from the outer hub; an inner tube coupled to the drive hub and coaxially located within the intermediate tube; and a cutting tip disposed in the inner tube. Each of the intermediate tube and the inner tube comprises at least one flexible region. The outer tube has at least one slotted region formed in which a row of slots forms a malleable spine, the malleable spine being configured to be bent and / or rebent by the user into a molded shape and to maintain the tube assembly in the molded shape.

[0014] According to a second aspect of the present disclosure, a cutting accessory comprises an outer hub configured to be coupled to a handpiece. A drive hub is rotatably positioned within the outer hub and configured to be operably coupled to a motor. A tube assembly comprises an outer tube coupled to the outer hub and extending distally from the outer hub, an inner tube coupled to the drive hub and coaxially positioned within the outer tube, and a cutting tip disposed within the inner tube, the inner tube comprising at least one flexible region. The outer tube is formed having a proximal malleable region separated from a distal malleable region to define a rigid proximal segment, a rigid intermediate segment, and a rigid distal segment of the tube assembly. The proximal and distal malleable regions are configured to be independently bent into a molded shape and / or rebent by the user and to maintain the tube assembly in a molded shape.

[0015] According to a third aspect of the present disclosure, a cutting accessory comprises an outer hub configured to be coupled to a handpiece. A drive hub is rotatably positioned within the outer hub and configured to be operably coupled to a motor. A tube assembly comprises an outer tube coupled to the outer hub and extending distally from the outer hub, an inner tube coupled to the drive hub and coaxially positioned within the outer tube, and a cutting tip disposed within the inner tube. The inner tube comprises at least one flexible region. The outer tube is formed with a proximal slotted region and a distal slotted region, in which the rows of slots form a proximal malleable spine and a distal malleable spine, respectively, and the proximal malleable spine and the distal malleable spine are configured to be independently bent into a molded shape and / or rebent by the user to maintain the tube assembly in a molded shape. The spacing between adjacent slots in the rows of slots in the proximal slotted region is greater than the spacing between adjacent slots in the rows of slots in the distal slotted region.

[0016] According to a fourth aspect of the present disclosure, a cutting accessory comprises an outer hub configured to be coupled to a handpiece. A drive hub is rotatably positioned within the outer hub and configured to be operably coupled to a motor. A tube assembly comprises an outer tube coupled to the outer hub and extending distally from the outer hub, and an inner tube coupled to the drive hub and coaxially positioned within the outer tube. The inner tube comprises at least one flexible region, and the outer tube is formed having a malleable region. The malleable region is formed with an initial pre-bend at a predetermined angle and is configured to be bent and / or re-bent by the user around a predetermined angle to maintain the tube assembly in the molded shape.

[0017] According to a fifth aspect of the present disclosure, a cutting accessory comprises an outer hub configured to be coupled to a handpiece. A drive hub is rotatably positioned within the outer hub and configured to be operably coupled to a motor. A tube assembly comprises an outer tube coupled to the outer hub and extending distally from the outer hub, and an inner tube coupled to the drive hub and coaxially positioned within the outer tube, the inner tube comprising at least one flexible region. The outer tube is formed having an initial fixed pre-bend and a malleable region positioned distal to the initial fixed pre-bend. The outer tube is further formed having at least one slotted region in which a row of slots forms a malleable spine, the malleable spine being configured to be bent and / or re-bent by the user into a molded shape and to maintain the tube assembly in the molded shape. [Brief explanation of the drawing]

[0018] [Figure 1] This is a perspective view of a powered surgical cutting instrument. The cutting accessory is detachably coupled to the handpiece. The cutting accessory comprises a tube assembly having at least one slotted region and a malleable spine. [Figure 2] This is a perspective view of one embodiment of a tube assembly. [Figure 3]It is an elevation view of the distal portion of the malleable tube assembly of FIG. 2. [Figure 4] It is a perspective view of one embodiment of a tube assembly in which a distal slot-provided area is separated from a proximal slot-provided area by a rigid intermediate segment. [Figure 5] It is a perspective view of one embodiment of a tube assembly in which a distal slot-provided area is radially offset and oriented with respect to a proximal slot-provided area. [Figure 6] It is a perspective view of one embodiment of a malleable tube assembly in which the spacing between adjacent slots varies between slot-provided areas. [Figure 7] It is an elevation view of one embodiment of a tube assembly in which a malleable area is formed with at least one initial pre-bend. [Figure 8] It is an elevation view of one embodiment of a tube assembly in which a malleable area is distal to at least one rigid pre-bend. [Figure 9] It is an elevation view of one embodiment of a tube assembly in which a malleable area is distal to at least one rigid pre-bend. The malleable area is of a length sufficient to provide a complex bend distal to the rigid pre-bend. [Figure 10] It is a view showing one embodiment of a tube assembly in which a sensor is positioned distal to a malleable area. The sheath is disposed over the sensor and the wire leads coupled to the sensor. [Figure 11] It is a detailed view within circle 11-11 of the embodiment of the tube assembly of FIG. 10. [Figure 12] It is an elevation view of a bending device configured to bend a tube assembly of a cutting accessory.

BEST MODE FOR CARRYING OUT THE INVENTION

[0019] Figure 1 shows a surgical cutting instrument 20 comprising a handpiece 22 and cutting accessories 24. The handpiece 22 is the main component, i.e., a component that is sterilized and configured to be reused across many surgical procedures. The cutting accessories 24 can be discarded after single use or can be manufactured to be sterilizable and reusable. The handpiece 22 comprises a power port or power cord 26, a suction port 28, and optionally an irrigation port 30. A motor (not shown) within the handpiece 22 is driven by power transmitted via a power cord 26 configured to be detachably coupled to a power source. The power source can be a surgical console, for example, an electric instrument driver sold by Stryker Corporation (Kalamazoo, Michigan) under the trade name CORE. The suction port 28 is configured to detachably receive a suction tube to establish a suction path between the cutting window 40 of the cutting tip 42 and a suction source (not shown) configured to detachably coupled to a suction tube. A suitable suction source is located on a waste management system marketed by Stryker Corporation under the trade name Neptune. In a particular embodiment, the irrigation port 30 is configured to removably receive an irrigation tube to establish an irrigation route between the cutting tip 42 and a source of irrigation fluid (not shown). An irrigation pump is configured to guide the irrigation fluid through the handpiece 22 and the cutting accessory 24 to be discharged from the cutting tip 42 at the surgical site. Alternatively, the suction source and / or irrigation pump can be integrated on a surgical console. The suction and irrigation routes of the surgical cutting instrument 20 may be similar to those disclosed in International Publication No. 2021 / 224862, published on November 11, 2021, and International Publication No. 2022 / 123535, published on June 16, 2022, by the same applicant, the entire contents of which are incorporated herein by reference.

[0020] The handpiece 22 defines at least one opening or cavity 32 configured to removably receive at least a portion of the cutting accessory 24. The cutting accessory 24 may include a drive hub 34 configured to be guided into the cavity 32 and may have at least one coupling shape configured to operably couple with a motor. The handpiece 22 and / or the cutting accessory 24 include complementary coupling features (not identified) for removably securing the cutting accessory 24 to the handpiece 22. The coupling features may be latches or other suitable coupling shapes, for example, those disclosed in International Publication No. 2021 / 224862 as described above.

[0021] The cutting accessory 24 comprises a housing also referred herein to as an outer hub 36. The outer hub 36 can be contoured to ergonomically conform to gripping and operation. The drive hub 34 is rotatably positioned within the outer hub 36. The tube assembly 38 extends distally from the outer hub 36 and comprises an outer tube 44, an inner tube 46, and optionally an intermediate tube 48. The outer tube 44 is coupled to the outer hub 36, the intermediate tube 48 is coaxially positioned within the outer tube 44, and the inner tube 46 is coaxially positioned within the intermediate tube 48 and coupled to the drive hub 34. Each of the tubes 44, 46, and 48 can extend distally from the outer hub 36. In other words, the tubes 44, 46, and 48 can have proximal ends located inside the outer hub 36. To put it another way, the tubes 44, 46, and 48, and especially the outer tube 44, can be more than just tubular segments located outside the outer hub 36.

[0022] The tube assembly 38 includes a cutting tip 42. In a particular embodiment, the cutting tip 42 is a toothed tip coupled to or provided on the inner tube 46. The intermediate tube 48 can define a cutting window 40 in which the inner tube 46 is rotatable within the intermediate tube 48. As a result, with the drive hub 34 operably coupled to the motor, the motor rotates the inner tube 46 to actuate the cutting blade to shear or reduce tissue in the cutting window 40. The excised tissue is aspirated through the cutting window 40 into the suction path. In another exemplary embodiment, the cutting tip 42 is a bar head coupled to the inner tube 46. The intermediate tube 48 can define a tubular distal end from which the bar head extends, and optionally, a hood can at least partially surround the bar head. With the drive hub 34 operably coupled to the motor, the motor rotates the inner tube 46 to cause the bar head to excise tissue. The cutting tip 42 can take on other suitable forms, and it is assumed that the surgical cutting instrument does not need to be electric. For example, the embodiment of the tube assembly 38 described can be a manual cutting instrument, such as a curette, rasp, blade tip, trephine, brush, etc., or can be used with a non-cutting manual or powered instrument, such as a screwdriver, endoscope camera, light assembly, etc.

[0023] The tube assembly 38 is configured to be bent and / or rebent by the user into a molded shape and to be maintained in that shape. More specifically, at least a portion of the tube assembly 38 has a malleable region that allows the user to bend the tube assembly 38 into a molded shape, and the tube assembly 38 is then sufficiently shape-retaining to maintain the molded shape despite the axial and radial forces associated with deploying the cutting end 42 to the surgical site. Referring to Figure 2, the outer tube 44 has at least one slotted region 50 in which a row of slots 52 forms at least one malleable spine 54, and the inner tube 46 has at least one flexible region (not identified) corresponding at least to the axial position of the slotted region(s) 50. In embodiments in which an intermediate tube 48 is present, the intermediate tube 48 also has at least one flexible region corresponding at least to the axial position of the slotted region(s) 50 and the axial position of the flexible region(s) of the inner tube 46. The malleable spine 54 is configured to be bent and / or rebent by the user into a molded form and to be maintained in that molded form, and the flexible regions of the inner tube 46 and intermediate tube 48 are configured to conform to the molded form maintained by the outer tube 44. The flexible regions can be achieved by several suitable methods, such as those disclosed in the aforementioned International Publication No. 2022 / 123535. In one example, the flexible region comprises comb-like segments connected to each other to define slots. The connection of the segments is configured to transmit torque along with the rotation of the inner tube 46 by a motor. Additionally or alternatively, the inner tube 46 may have helical, spiral, wound, or braided properties configured to transmit torque around the bend(s) of the tube assembly 38 in the molded form. The flexible regions can be formed by a different cutting shape from the slot rows 52 of the slotted region 50 of the outer tube 44.

[0024] Where used herein, the slot row 52 represents at least two slots axially spaced apart from one another to provide bending; however, in exemplary embodiments, typically, it comprises many slots arranged along the outer tube 44 in the numerous configurations described. Furthermore, in alternative configurations, there are one or more helical slots extending around the outer tube 44 with appropriate pitch and an orthogonal cutting pattern in which axial and circumferential slots are alternately arranged, the orthogonal cutting pattern in which axial and circumferential slots are alternately arranged has been empirically shown to reduce the bending stiffness to about 25% of the bending stiffness of an uncut tube. The slots 52 do not have to be linear and can instead be formed in curved or zigzag configurations or other complex shapes.

[0025] For the material forming the tube assembly 38, the malleable spine 54 is configured to reversibly plastically deform, thereby maintaining the tube assembly 38 in a molded form. Suitable materials include stainless steel, aluminum, or other biocompatible metals, plastics, polymers, or composites having a suitable yield strength to provide malleability. Exemplary metals include 316L stainless steel and 3003 aluminum, having yield strengths of 515 megapascals (MPa) and 186 MPa, respectively. The slotted regions 50 can be manufactured by any suitable manufacturing technique, including but not limited to laser cutting, electrical discharge manufacturing (EDM), and 3D printing.

[0026] Figures 2 and 3, when viewed together, show a slotted area 50 comprising an upper slot row 52u and a lower slot row 52l separated from the upper slot row 52u by a malleable spine 54. Another malleable spine (not visible in the drawing) is located on the opposite side of the outer tube 44. Thus, the cutting accessory 24 allows the user to bend the tube assembly 38 upward, with the upper slot row 52u narrowing and the lower slot row 52l widening, and / or downward, with the lower slot row 52l narrowing and the upper slot row 52u widening. The extent to which the user can bend the tube assembly 38 is partly a function of the kerf (k) of the slot 52, where a larger kerf allows for greater adjustment of the bending angle. As used herein, kerf is the width of the slot. The kerf (cut width) of the slot 52 can be in the range of about 0.02 mm to 0.08 mm, more specifically about 0.05 mm.

[0027] Referring to Figure 3, further bending characteristics of the tube assembly 38 are shown by the segment length (l s The segment length can be based on the non-cutting angle (γ) and the corresponding cutting angle (not shown), the upper slot angle (α), and the lower slot angle (β). The segment length can be considered as the length of the outer tube 44 between adjacent slots 52, i.e., the distance between adjacent slots 52. The segment length can be the same along the length of the slotted area 50 (Figures 2 to 5) or vary (Figure 6). For example, the segment length can be in the range of about 0.5 mm to 2.5 mm, more specifically, in the range of about 0.1 mm to 2.0 mm. Furthermore, the segment length of the upper slot row 52u can be the same as or different from the segment length of the lower slot row 52l. Furthermore, the segment length can be the same along the length of the slotted area 50, but the axial positions of the upper slot row 52u and the lower slot row 52l can be "staggered" (e.g., not on the same plane in the axial direction as shown in Figure 3).

[0028] The slots 52 extend circumferentially around a portion of the outer tube 44. The non-cut angles can be considered as the respective arcs that the malleable spines 54 stretch over the outer tube 44, and the cut angles can be considered as the respective arcs that the upper slot rows 52u and the lower slot rows 52l stretch over the outer tube 44. The sum of the non-cut angles and the cut angles is equal to 360 degrees. For illustrative purposes, Figure 3 shows the coaxial center point (C) of the tube assembly 38, and the non-cut angles can be measured between one end of the upper slots 52u and the corresponding end of the lower slots 52l. The cut angles can be measured between the opposing ends of one end of the slots 52. In one example, the non-cut angles can be in the range of approximately 40 to 100 degrees, more specifically, approximately 60 to 80 degrees. The cut angles can be in the range of approximately 60 to 120 degrees, more precisely, approximately 80 to 100 degrees. Other values ​​are also within the scope of this disclosure. Generally, the non-cutting angles and cutting angles can be selectively designed to provide a desired combination of flexibility, allowing the user to bend the tube assembly 38 into a molded form, and to have shape retention to maintain the molded form after bending. The cutting angle (α) of the upper slot row 52u may differ from the cutting angle (β) of the lower slot row 52l, or vice versa, in which case it is assumed that certain slots 52 can be formed "deeper" into the outer tube 44 with a larger cutting angle. Furthermore, the non-cutting angle associated with one of the malleable spines 54 may differ from the non-cutting angle (γ) of another of the malleable spines 54, in which case it is assumed that the slots 52 can be radially offset (see Figure 5).

[0029] The upper and lower slot angles can be defined between the longitudinal axis (LA) and a plane extending through one of the upper slots 52u and the lower slots 52l, respectively. Figure 3 shows that the upper and lower slot angles are 90 degrees. In other words, the slots 52 in the illustrated embodiment traverse the longitudinal axis of the tube assembly 38. In alternative modifications, the upper and / or lower slot angles can be less than 90 degrees so that the slot row 52 is oriented proximal, or greater than 90 degrees so that the slot row 52 is oriented distal. The upper slot angle does not have to be the same as the lower slot angle. Furthermore, in modifications where the segment lengths differ between the upper and lower slot rows 52u and 52l, varying the upper and / or lower slot angles provides more complex shapes to achieve a desired combination of flexibility and shape retention. Empirical data have enabled the development of the advantageous design disclosed herein, which achieves a bending angle of more than 60 degrees while withstanding a load of at least 15 Newtons on the cut end 42 in the molded form.

[0030] In relation to Figure 1, Figure 2 shows a slotted region 50 extending along substantially the entire exposed length of the outer tube 44 distal to the outer hub 36. In a particular embodiment, the length of the tube assembly 38 distal to the outer hub 36 can be 20 to 50 centimeters, depending on the clinical application. The slotted region 50 can extend distal to the outer hub 36 along 25 percent, 50 percent, 75 percent, 90 percent, or more of the length of the tube assembly 38. In another embodiment shown in Figure 4, at least one slotted region 50 is a proximal slotted region 50p, and the outer tube 44 is further formed having a distal slotted region 50d separated from the proximal slotted region 50p. The proximal slotted region 50p and the distal slotted region 50d define the rigid proximal segment 44p, the rigid intermediate segment 44i, and the rigid distal segment 44d of the tube assembly 38. The rigid distal segment 44d is also referred to herein as the tube head. Such embodiments are particularly suitable for laryngeal and other clinical procedures where the tube assembly 38 is relatively large and the middle portion of the tube assembly 38 is unlikely to require bending. The length of the tube head (l h (See Figure 3) can be relatively short, for example, 1 centimeter or less. One or both of the proximal slot-attached region 50p and the distal slot-attached region 50d may have any of the slot 52 characteristics described throughout this disclosure, namely, kerf (cut width), segment length, non-cutting angle, cutting angle, upper slot angle, and lower slot angle. The slot characteristics of the proximal slot-attached region 50p may be the same as or different from the slot characteristics of the distal slot-attached region 50d.

[0031] The length of the proximal slot-attached region 50p can be the same as or different from the length of the distal slot-attached region 50d. In the embodiment shown in Figure 4, the length of the proximal slot-attached region 50p (L P ) is the length (L) of the distal slot attachment area 50dD This indicates that it is larger than ). Similarly, the lengths of the rigid proximal segment 44p, rigid intermediate segment 44i, and rigid distal segment 44d of the tube assembly 38 can be designed to position the proximal slotted region 50p and the distal slotted region 50d at desired axial positions along the outer tube 44. The axial positions of the proximal slotted region 50p and the distal slotted region 50d in the illustrated embodiment may be illustrative of those for laryngeal applications. It is understood that the cutting window 40 can be modified from that shown in Figure 4 based on the expected bending angle of the distal slotted region 50d.

[0032] As described above, the upper slot row 52u and the lower slot row 52l generally allow the user to bend the tube assembly 38 upward and / or downward. In other words, after bending or re-bending, the tube assembly 38 typically remains coplanar along a vertical plane corresponding to a user holding the surgical cutting instrument 20 in an upright position. In certain embodiments, it may be desirable to have two or more bends, and the cutting end may be offset in at least two directions relative to a straight tube assembly. Figure 5 shows one embodiment of a configuration in which the slot row 52 of the proximal slotted region 50p is formed to orient the proximal malleable spine 54p in a first rotational direction. The slot row 52 of the distal slotted region 50d is formed to orient the distal malleable spine 54d in a second rotational direction different from the first rotational direction. With respect to a vertical plane extending vertically through the longitudinal axis, the proximal slotted region 50p is at a proximal radial angle (ε P The distal slot-equipped region 50d can be oriented to a distal radial angle (ε) that is different from the proximal radial angle. D) can be oriented in the following direction. In the illustrated embodiment, the proximal radial angle is zero degrees. In other words, the upper slot row 52u and the lower slot row 52l (not visible in the drawing) described above are aligned along the vertical plane. The distal radial angle can be non-zero. For example, the distal radial angle can be in the range of approximately 10 to 170 degrees. Figure 5 shows a distal radial angle of approximately 45 degrees, i.e., at the 2 o'clock position, and it can be seen that another slot row (not visible in the drawing) can be positioned on the opposite side of the outer tube 44. With such a configuration, the user can bend the rigid distal segment 44d laterally relative to the rigid intermediate segment 44i.

[0033] Depending on other characteristics of the slots 52 in the distal slotted region 50d, in addition to lateral bendability, some degree of upward and downward bendability can also be provided. By convention, the proximal radial angle and distal radial angle can instead be measured between the vertical plane and the proximal malleable spine 54p and distal malleable spine 54d, respectively. It should be understood that the illustrated configuration is a non-limiting example, and all other embodiments of this disclosure can be incorporated onto a tube assembly 38 having one or more radially offset slotted regions 50. In one example, the tube assembly 38 does not need to have a rigid intermediate segment 44i; rather, the slotted region 50 can extend over substantially the entire exposed length of the tube assembly 38, and at appropriate locations, one of the slots 52 in the row of slots 52 is radially offset, i.e., “shifted clockwise,” relative to the directly adjacent slot 52. In another example, the proximal slot-attached region 50p can be radially offset with respect to the vertical plane while the distal slot-attached region 50d is aligned with the vertical plane, or it can be radially offset at a distal radial angle different from the proximal radial angle. The hub 36 and / or tube assembly 38 are expected to be provided with a visual indication of the direction of the bend. The visual indication can be, for example, laser etching, printed marking, etc.

[0034] Referring here to Figure 6, another embodiment of the tube assembly 38 is shown in which the spacing between slots 52 differs along the length of the outer tube 44. In other words, the segment lengths differ (see Figure 3). This embodiment can be combined with any of the other embodiments of the present disclosure. In one exemplary configuration, the spacing between adjacent slots in the slot row 52 of the proximal slotted region 50p is greater than the spacing between adjacent slots in the slot row 52 of the distal slotted region 50d. For example, in laryngeal procedures, it is typically necessary to make the curvature of the distal bend steeper and the curvature of the proximal end gentler. The illustrated embodiment shows that the spacing between pairs of slots 52 in the proximal slotted region 50p is greater than the uniform spacing in the distal slotted region 50d. As a result, the user can bend the distal slotted region 50d to make its radius of curvature greater than that of the proximal slotted region 50p. In one optional modification, Figure 6 shows an intermediate slotted region 50i, where the spacing between adjacent slots in the slot row 52 of the intermediate slotted region 50i differs from the spacing in the proximal slotted region 50p and the distal slotted region 50d, respectively. As described above, the tube assembly 38 for laryngeal procedures can be relatively large with an intermediate portion that is likely to require minimal bending. The intermediate slotted region 50i reflects this consideration by allowing some degree of bending, but otherwise being more shape-retaining than the proximal slotted region 50p and the distal slotted region 50d. More specifically, the spacing in the intermediate slotted region 50i is larger than the spacing in the proximal slotted region 50p and the distal slotted region 50d, respectively, and therefore, generally, is limited to sharp bending, similar to the proximal slotted region 50p and the distal slotted region 50d.

[0035] In a particular embodiment, the tube assembly 38 is formed in an initial linear form, and thereafter, the slotted region(s) 50 can be bent as desired. The range over which the slotted region(s) 50 can be bent is based on the longitudinal axis of the linear tube assembly 38. In other embodiments where bending is known to be necessary (e.g., laryngeal procedures), the tube assembly 38 can be formed with an initial pre-bend that approximates the form that is likely to be formed as required for the procedure. The bending range of the slotted region(s) 50 is then based on the initial pre-bend, thereby providing the user with a larger range of more relevant bending angles. Referring now to Figure 7, one embodiment of the tube assembly 38 is shown in which a proximal malleable spine 54p has a proximal initial pre-bend at a predetermined proximal angle (δ), and a distal malleable spine 54d has a distal initial pre-bend at a predetermined distal angle (θ). The predetermined proximal and distal angles can be the same or different, and can be of any appropriate size. For example, within a range of approximately 45 to 175 degrees, more specifically, within a range of approximately 90 to 135 degrees. As a result, the proximal ductile spine 54p and the distal ductile spine 54d are configured to bend and / or rebend into a molded shape around a predetermined proximal angle and a predetermined distal angle, respectively.

[0036] It is understood that either the proximal malleable spine 54p or the distal malleable spine 54d may have an initial pre-bend, while the other may be in an initial linear configuration. For example, the distal malleable spine 54d may have a rigid (i.e., absence of slotted region 50) or malleable initial pre-bend, while the proximal malleable spine 54p may be in an initial linear configuration. In yet another modification, the proximal initial pre-bend may be rigid, and the distal slotted region 50d may be separated from the rigid proximal pre-bend by a rigid intermediate segment. Embodiments having an initial pre-bend may also have any of the slot characteristics described throughout this disclosure, namely the kerf (cut width), segment length, non-cutting angle, cutting angle, upper slot angle, and lower slot angle.

[0037] Figures 8 and 9 show embodiments of a tube assembly 38 in which an initial fixed pre-bend (i.e., non-ductile) of a solid section 51 is present. The initial fixed pre-bend can be a predetermined angle (δ) in the range of about 60 to 120 degrees, more specifically in the range of about 80 to 100 degrees, and even more specifically, about 90 degrees. Slotted regions (there may be more) 50 are positioned distal to the initial fixed pre-bend and can be of any appropriate length based on the target anatomical structure. The slotted region 50 in Figure 8 is shorter and can provide a single bend, while the one in Figure 9 is longer and can provide a composite bend in addition to the initial fixed pre-bend.

[0038] Embodiments having initial fixation pre-bending can be particularly suitable for accessing sinuses, more specifically, the maxillary sinus or frontal sinus. For example, in cases where the sinus may be partially or completely occluded, the surgeon can bend the slotted region 50 to reach the lower medial or lateral side of the maxillary sinus. Furthermore, initial fixation pre-bending can advantageously provide rigidity to the tube assembly 38 to account for the lever action that may occur between the cutting accessory 24 and a rigid anatomical structure (e.g., the base of the skull). Moreover, initial fixation pre-bending can be considered more intuitive with respect to the bending direction, in contrast to other embodiments where the majority of the length of the tube assembly 38 is malleable.

[0039] Referring again to Figures 1 and 2, the tube assembly 38 can be a two-tube or three-tube configuration. In a two-tube configuration, the outer tube 44 has a slotted area(s) 50 that further defines the cutting window 40. The inner tube 46 is motor-driven and rotates within the outer tube 44. In a three-tube configuration, the intermediate tube 48 is coaxially positioned between the outer tube 44 and the inner tube 46 and defines the cutting window 40. In a particular embodiment, the intermediate tube 48 facilitates the rotational adjustment of the cutting window 40. The cutting accessory 24 may include an actuator 60 coupled to the outer hub 36 and operably coupled to the intermediate tube 48. This coupling can be facilitated by appropriate gearing within the outer hub 36, such as bevel gearing, worm gearing, etc. Figure 1 shows the actuator 60 as a barrel-type thumbwheel configured to receive input from a user gripping the surgical cutting instrument 20. Other suitable actuators include a rotatable dial, a swivel lever, etc. The input to the actuator 60 is configured to rotate the intermediate tube 48 relative to the outer tube 44, allowing the inner tube 46 to rotate the cutting window 40 around its longitudinal axis.

[0040] In a two-tube configuration providing suction and irrigation, it may be necessary to prevent the discharge of irrigation fluid from the slotted region 50 of the outer tube 44. The cutting accessory 24 may include a first liner (not shown) coupled to the outer tube 44 and positioned above the slotted region 50. The first liner may be a heat-shrinkable tubing positioned on the outer surface of the outer tube 44, or a tubular jacket coupled to the inner surface of the outer tube 44. Similarly, it may be necessary to prevent the ingress of irrigation fluid from the irrigation path into the suction path defined by the inner tube 46. A second liner (not shown) coupled to the inner tube 46 may be positioned above or inside the flexible region(s) of the inner tube 46. In a three-tube configuration, a third liner (not shown) may be provided, coupled to the intermediate tube 48, and positioned above or inside the flexible region(s) of the intermediate tube 48.

[0041] Navigation of surgical instruments is becoming increasingly common in modern operating rooms. Known devices that enable navigation are typically rigid, so that the calibrated position of the shaft tip remains stationary relative to, for example, a tracking array coupled to the handpiece. Alternatively, certain devices that enable navigation may require calibration and alignment of the tip to the tracking array. Such solutions cannot cope with the in-situ adjustments provided by the tube assembly 38 of the present disclosure. In other words, it is cumbersome to require the user to realign the cutting tip 42 in the navigation software every time the tube assembly 38 is bent and rebent. Therefore, in certain embodiments, the cutting accessory 24 of the present disclosure overcomes such drawbacks by providing a sensor 62 (see Figure 11) coupled to the tube assembly 38 and positioned distal to the malleable region. Referring to Figures 10 and 11, the sensor 62 is coupled to the rigid distal segment 44d, i.e., the tube head distal to the slotted region 50. The sensor 62 is positioned in a fixed spatial relationship with respect to a predetermined point on the cut end 42, for example, the furthest point. The sensor 62 can be an electromagnetic (EM) sensor or other suitable tracking technique that does not require a line of sight. As a result, regardless of the nature and number of bends applied to the tube assembly 38, the data indicating the position of the cut end 42 transmitted from the sensor 62 to the navigation software is maintained with sufficient accuracy and does not require repositioning after successive bending events.

[0042] Lead 64 is configured to couple sensor 62 to an electronic subcomponent (not shown) within the outer hub 36. Lead 64 may extend proximal to sensor 62 and / or along the malleable spine 54 to limit strain associated with bending of the tube assembly 38. Lead 64 may be a twisted wire pair to reduce interference from sensor 62. A second sensor may be coupled to the outer tube 44 on the opposite side from that shown in Figure 9, with the second lead extending along the opposite malleable spine.

[0043] The sensor 62 and lead 64 can be secured to the outer tube 44 by a sheath 66. The sheath 66 may be the first liner described above, or alternatively, the sheath 66 may be an addition to the first liner. The sheath 66 may be a heat-shrinkable material, a polymer jacket secured to the outer tube 44, etc., to secure the position of the sensor 62 and lead 64 in a discreet manner that does not obstruct the visualization of the cut end 42 when viewed along the tube assembly 38.

[0044] The bending of the tube assembly 38 can be performed manually by the user. Additionally or alternatively, a bending device 70, such as the one shown in Figure 12, can be provided to assist the user. The bending device 70 can be packaged in a kit together with the cutting accessory 24. Figure 12 shows an example of a bending device 70 with the cutting accessory 24 placed inside. The bending device 70 may comprise opposing jigs 72. The jigs 72 define slots configured to align with each other so that the tube assembly 38 of the cutting accessory 24 can be inserted in a linear form. The user can insert the tube assembly 38 to position the desired position of the bend at the boundary between the two jigs 72. The bending device 70 may comprise at least one actuator 74 configured to receive input from the user to rotate one or both of the jigs 72 relative to each other. The jigs 72 can be rotated in opposing directions to impart a bend to the tube assembly 38, for example, as shown in Figure 12. To provide an indication of the bending angle to be applied to the tube assembly 38, a display can be placed on the jig 72 or back plate of the bending device 70.

[0045] The foregoing disclosure is not intended to be exhaustive or to limit the invention to any particular form. The terms used are intended to be descriptive rather than restrictive. In light of the foregoing teachings, many modifications and variations are possible, and the invention can be carried out in ways other than those specifically described. For example, malleability does not have to be provided by slots, but can instead be based on the material forming the outer tube 44. In such an example, the tube assembly 38 may have malleable regions instead of slotted regions 50.

Claims

1. A cutting accessory configured to be detachably attached to the handpiece of a surgical cutting instrument equipped with a motor, An outer hub configured to be coupled to the aforementioned handpiece, A drive hub is rotatably disposed within the outer hub and configured to be operably coupled to the motor, A tube assembly comprising: an outer tube coupled to the outer hub and extending distally from the outer hub; an intermediate tube coaxially disposed within the outer tube and extending distally from the outer hub; an inner tube coupled to the drive hub and coaxially disposed within the intermediate tube; and a cut end disposed on the inner tube, wherein each of the intermediate tube and the inner tube comprises at least one flexible region. A cutting accessory having at least one slotted region formed by a row of slots, wherein the outer tube is configured to be bent and / or rebent by the user into a molded shape and to hold the tube assembly in the molded shape, and a malleable spine is formed therein.

2. The cutting accessory according to claim 1, wherein the at least one slotted region further includes a proximal slotted region, and the outer tube is formed further having a distal slotted region separated from the proximal slotted region to define a rigid proximal segment, a rigid intermediate segment, and a rigid distal segment of the tube assembly.

3. The cutting accessory according to claim 2, wherein the row of slots in the proximal slot-attached region is formed to orient the malleable spine of the proximal slot-attached region in a first rotational direction, and the row of slots in the distal slot-attached region is formed to orient the malleable spine of the distal slot-attached region in a second rotational direction different from the first rotational direction.

4. The cutting accessory according to claim 3, wherein the surgical cutting instrument is configured to be handled by the user in an upright position, and the first direction of rotation is configured to be aligned with a vertical plane corresponding to the upright position.

5. The cutting accessory according to any one of claims 2 to 4, wherein the spacing between adjacent slots in the slot row of the proximal slot-attached region is greater than the spacing between adjacent slots in the slot row of the distal slot-attached region.

6. The cutting accessory according to claim 1, wherein the tube assembly is formed to further have a rigid proximal pre-bend, and the slotted region further comprises a distal slotted region spaced apart from the rigid proximal pre-bend.

7. The cutting accessory according to claim 1, wherein the tube assembly is formed in an initial linear form extending from the outer hub along the longitudinal axis, and the malleable spine is configured to be bent and / or re-bent about the longitudinal axis into the molded form.

8. The cutting accessory according to claim 1, wherein the malleable spine is formed with an initial pre-bend at a predetermined angle and is configured to be bent and / or re-bent around the predetermined angle to the formed shape.

9. The cutting accessory according to any one of claims 1 to 8, wherein the slot-equipped region extends along substantially the entire exposed length of the outer tube.

10. The cutting accessory according to any one of claims 1 to 9, further comprising an actuator coupled to the outer hub and the intermediate tube, wherein the actuator is configured to receive input from the user to rotate a cutting window defined by the intermediate tube relative to the outer tube.

11. The cutting accessory according to any one of claims 1 to 10, wherein the at least one flexible region of the intermediate tube is formed by a different cutting shape from the row of slots in the slotted region of the outer tube.

12. The cutting accessory according to any one of claims 1 to 11, further comprising a first liner coupled to the outer tube and positioned above the slotted region.

13. The cutting accessory according to claim 12, further comprising a second liner coupled to the inner tube and positioned on the at least one flexible region of the inner tube.

14. The cutting accessory according to claim 13, further comprising a third liner coupled to the intermediate tube and positioned on the at least one flexible region of the intermediate tube.

15. A cutting accessory configured to be detachably attached to the handpiece of a surgical cutting instrument equipped with a motor, An outer hub configured to be coupled to the aforementioned handpiece, A drive hub is rotatably disposed within the outer hub and configured to be operably coupled to the motor, A tube assembly comprising an outer tube coupled to the outer hub and extending distally from the outer hub, an inner tube coupled to the drive hub and coaxially disposed within the outer tube, and a cut end disposed in the inner tube, wherein the inner tube comprises at least one flexible region. Equipped with, A cutting accessory wherein the outer tube is formed having a proximal malleable region and a distal malleable region separated from the proximal malleable region to define a rigid proximal segment, a rigid intermediate segment, and a rigid distal segment of the tube assembly, and the proximal malleable region and the distal malleable region are configured to be independently bent into a molded shape and / or rebent by the user and to maintain the tube assembly in the molded shape.

16. The cutting accessory according to claim 15, wherein each of the proximal and distal malleable regions is formed by a row of slots extending circumferentially around a portion of the outer tube.

17. The cutting accessory according to claim 16, wherein the row of slots in the proximal malleable region forms a proximal malleable spine oriented in a first rotational direction, and the row of slots in the distal malleable region forms a distal malleable spine oriented in a second rotational direction different from the first rotational direction.

18. The cutting accessory according to claim 17, wherein the surgical cutting instrument is configured to be handled by the user in an upright position, and the first direction of rotation is configured to be aligned with a vertical plane corresponding to the upright position.

19. The cutting accessory according to claim 17 or 18, wherein the tube assembly is formed in an initial linear configuration in which the proximal malleable spine and the distal malleable spine extend along the longitudinal axis, and the proximal malleable spine and the distal malleable spine are configured to be bent and / or re-bent about the longitudinal axis into the formed configuration.

20. The cutting accessory according to claim 17 or 18, wherein at least one of the proximal malleable spine and the distal malleable spine is formed with an initial pre-bend at a predetermined angle and is configured to be bent and / or re-bent around the predetermined angle to the formed shape.

21. The cutting accessory according to any one of claims 16 to 20, wherein the spacing between adjacent slots in the slot row of the proximal slot-equipped region is greater than the spacing between adjacent slots in the slot row of the distal slot-equipped region.

22. The cutting accessory according to any one of claims 15 to 21, further comprising an intermediate tube coaxially positioned between the outer tube and the inner tube, wherein the tube assembly further comprises an intermediate tube.

23. A cutting accessory configured to be detachably attached to the handpiece of a surgical cutting instrument equipped with a motor, An outer hub configured to be coupled to the aforementioned handpiece, A drive hub is rotatably disposed within the outer hub and configured to be operably coupled to the motor, A tube assembly comprising an outer tube coupled to the outer hub and extending distally from the outer hub, an inner tube coupled to the drive hub and coaxially disposed within the outer tube, and a cut end disposed in the inner tube, wherein the inner tube comprises at least one flexible region. Equipped with, A cutting accessory wherein the outer tube has a proximal slotted region and a distal slotted region formed thereon, in the proximal slotted region and the distal slotted region, the slot rows form a proximal malleable spine and a distal malleable spine, respectively, the proximal malleable spine and the distal malleable spine are configured to be independently bent into a molded shape and / or re-bent by the user to maintain the tube assembly in the molded shape, and the spacing between adjacent slots in the slot rows of the proximal slotted region is greater than the spacing between adjacent slots in the slot rows of the distal slotted region.

24. The cutting accessory according to claim 23, wherein the tube assembly further comprises an intermediate tube coaxially positioned between the outer tube and the inner tube.

25. A cutting accessory configured to be detachably attached to the handpiece of a surgical cutting instrument equipped with a motor, An outer hub configured to be coupled to the aforementioned handpiece, A drive hub is rotatably disposed within the outer hub and configured to be operably coupled to the motor, A tube assembly comprising an outer tube coupled to the outer hub and extending distally from the outer hub, and an inner tube coupled to the drive hub and coaxially disposed within the outer tube, wherein the inner tube has at least one flexible region and the outer tube is formed having a malleable region, Equipped with, A cutting accessory wherein the malleable region is formed with an initial pre-bend at a predetermined angle, and is configured to be bent and / or re-bent by the user around the predetermined angle to maintain the tube assembly in the molded shape.

26. The cutting accessory according to claim 25, wherein the tube assembly further comprises an intermediate tube coaxially positioned between the outer tube and the inner tube.

27. A cutting accessory configured to be detachably attached to the handpiece of a surgical cutting instrument equipped with a motor, An outer hub configured to be coupled to the aforementioned handpiece, A drive hub is rotatably disposed within the outer hub and configured to be operably coupled to the motor, A tube assembly comprising an outer tube coupled to the outer hub and extending distally from the outer hub, and an inner tube coupled to the drive hub and coaxially disposed within the outer tube, wherein the inner tube has at least one flexible region, and the outer tube is formed having an initial fixed pre-bend and a malleable region positioned distal to the initial fixed pre-bend, Equipped with, A cutting accessory wherein the outer tube has at least one slotted region formed in which a row of slots forms a malleable spine, and the malleable spine is configured to be bent and / or rebent by the user to maintain the tube assembly in the molded shape.

28. The cutting accessory according to claim 27, wherein the initial fixed pre-bending has a predetermined angle in the range of about 60 degrees to 120 degrees.

29. A sensor positioned distal to the slotted area or the malleable area, A lead coupled to the sensor and extending proximal to the sensor, configured to be coupled to an electronic subcomponent of the outer hub, A sheath connecting the sensor and the lead to the outer tube, A cutting accessory according to any one of claims 1 to 28, further comprising:

30. The cutting accessory according to claim 29, wherein the lead extends along the malleable spine of the slot-equipped region.

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