Certain surgical instruments are developed for use with surgical procedures in which access, maneuverability, and visibility are limited. One example is a surgical shaver for procedures of the ear, nose, and throat (ENT), and another example is a surgical bur. The surgical instruments may include a tube assembly in which an inner tube or drive shaft is rotatably disposed within an outer tube, and a cutting window is positioned radially and proximally to a distal tip of the tube assembly. The tissue exposed to the cutting window is therefore based on the orientation of the cutting window and the approach by which the surgeon introduces the surgical instrument into the anatomy. Known devices may undesirably require removing the surgical instrument from the anatomy to reintroduce it in the desired approach. Moreover, the surgical instrument is often designed to be comfortably held in a particular manner, and repositioning in the hand of the surgeon may be unergonomic.
It is further known to include a bend to the tube assembly to provide greater access to certain anatomy. The presence of the bend, however, compounds the aforementioned shortcomings of known devices. Namely, the tissue exposed to the cutting window is further based on the orientation of the bend. For example, the bend may be oriented upwardly relative to the handpiece, and the cutting window may be oriented on a concave side of the tube assembly. For a given approach by which the surgeon introduces the surgical instrument into the anatomy, any number of combinations of the orientation of the cutting window and the orientation of the bend may be preferred, or may become more preferable over the course of the surgical procedure.
Certain known devices provide for orienting the cutting window and/or the bend. One such device is disclosed in commonly-owned International Publication No. 2017/163226, published Sep. 28, 2017, the entire contents of which are hereby incorporated by reference. It is disclosed that a wheel may be rotated to orient the cutting window. It is further disclosed that the tube assembly may be operably decoupled from the handpiece to selectively orient the bend in one of a limited number configurations.
Therefore, there is a need in the art for a surgical cutting assembly that provides for selective adjustment of more than one component of the surgical cutting assembly in an intuitive, ergonomic, and efficient manner.
The surgical cutting assembly of the present disclosure overcomes at least the above shortcomings. The surgical cutting assembly includes an actuator assembly that is operable in at least a first mode and a second mode. A wheel may be rotatable in the first mode for adjusting a first component of the surgical cutting assembly, and in the second mode for adjusting a second component of the surgical cutting assembly. For example, the actuator assembly provides for orienting the cutting window in the first mode, and orienting the bend of a tube assembly in the second mode. The wheel may be rotatable in a first axial position in the first mode, and in a second axial position in the second mode. The second axial position may be proximal to the first axial position.
The actuator assembly may be operably coupled to an intermediate tube in the first mode, and rotating the wheel in the first axial position rotates the intermediate tube. The actuator assembly may be operably decoupled from the outer tube in the first mode, and operably decoupled from the intermediate tube in the second mode. The actuator assembly may be operably coupled to the outer tube in the second mode, and rotating the wheel in the second axial position rotates the outer tube. The wheel may be axially movable relative to the housing between the first mode and the second mode. The actuator assembly may include a biasing member coupled to the wheel. The biasing member may bias the actuator assembly to be in the first mode, or alternatively to be in the second mode. The actuator assembly may include a first gear, a second gear secured to the outer tube, and a third gear secured to the intermediate tube.
In certain implementations, the actuator assembly includes the wheel, a first gear, a second gear, and a third gear. The first gear, the second gear, and/or the third gear may be configured to form a Hirth joint. The first gear, the second gear, and/or the third gear, may be a Hirth joint including teeth annularly arranged and oriented proximally or distally to form a face gear with complementary engagement features. Other types of gears may include spur, helical, bevel, worm, screw, and the like. Any suitable joint to be selectively disengaged and reengaged to transmit forces from a rotational input may be provided.
The second gear may be secured to the outer tube at an interface, and the third gear may be secured to the intermediate tube at an interface. The interfaces may be provided by one or more of adhesive, fasteners, friction fit, interference fit, or the like. Rotation of the second gear rotates the outer tube, and therefore the bend of the tube assembly is correspondingly reoriented. Rotation of the third gear rotates the intermediate tube, and with the intermediate tube defining the cutting window, the cutting window of the tube assembly is correspondingly reoriented. The rotation of the wheel with the actuator assembly in the first mode is configured to rotate the third gear, and the rotation of the wheel with the actuator assembly in the second mode is configured to rotate the second gear.
The wheel may include a distal wheel portion and a proximal wheel portion. The distal wheel portion and the proximal wheel portion may be discrete components separately formed and secured to one another to form the wheel. The distal wheel portion and the proximal wheel portion may include joining features configured to facilitate the assembly of the wheel. With the distal wheel portion and the proximal wheel portion secured to one another, the first cavity and the second cavity are sized to accommodate the subcomponents of the actuator assembly, namely the first gear, the second gear, the third gear, the biasing element, and the bearings. The distal wheel portion may include a contour different than a contour of the proximal wheel portion to form a flared surface. The flared surface may be considered more vertically oriented to provide for a larger contact area to pinch and pull the wheel with the thumb and the index finger.
According to a second aspect, an actuator assembly for a surgical instrument is provided. A wheel defines a cavity, and a first gear, a second gear, and a third gear are disposed within the cavity. The second gear is secured to a first subcomponent, and a third gear secured to a second subcomponent. The first component may be an outer tube for any surgical instrument, and the second component may be a shaft, for example a solid drive shaft or another tube. The second component may be the solid shaft, and an end effector may be reoriented. Such examples include a radially disposed electrode for ablation, an eccentrically deployed balloon for kyphoplasty, a radial side port for vertebroplasty, and the like. In such an arrangement, the inner tube may be optional.
The first gear may be selectively engaged with the housing. The second gear may be selectively engaged with the wheel. The third gear may be selectively engaged with the wheel. The first gear includes engagement features that are configured to engage with engagement features of the nose portion of the housing. The first gear may include a first ring with the engagement features being teeth oriented distally and annularly arranged about the first ring. The first gear is sized to be positioned within the first cavity defined by the distal wheel portion. The distal surface of the distal wheel portion defines an opening through which the engagement features of the first gear extend, and the first ring is in interference engagement with an inner surface defining the first cavity. The engagement features of the nose portion may be teeth oriented proximally and annularly arranged in a manner complementary to the teeth of the first gear. With the engagement features of the first gear extending distal to the distal surface of the distal wheel portion, the complementary engagement features are configured to be in selective engagement based on the axial position of the wheel.
The first gear and the second gear may include complementary keying features configured to prevent relative rotation and permit relative translation between the first gear and the second gear. The keying feature of the first gear may be at least one rail, and the keying feature on the second gear may be at least one slot. The first ring of the first gear defines an opening, and the rail is arranged axially within the opening. The neck of the second gear has an outer diameter less than an inner diameter of the opening of the first ring such that the complementary keying features provide for axial translation but not rotation between the first gear and the second gear in each of the first mode and the second mode.
The second gear includes engagement features configured to engage the engagement features of the distal wheel portion. The second gear may include a second ring from which the neck extends distally, and the engagement features of the second gear may be teeth annularly arranged and oriented distally about the second ring. The third gear includes engagement features configured to engage the engagement features of the proximal wheel portion. The third gear may include a third ring, and the engagement features of the second gear may be teeth annularly arranged and oriented proximally about the third ring.
Advantages of the inventions will be readily appreciated with the written description being considered in connection with the following drawings.
With further reference to
The housing 26 may include a finger portion 36 and a web portion 38 spaced apart and contoured to ergonomically support a hand of the surgeon. In particular, the finger portion 36 and the web portion 38 may at least partially define a cavity within which a web of the hand of the surgeon may be comfortably supported. Modifications to the housing 26 are contemplated with additional ergonomic arrangements being disclosed in the aformentioned International Publication No. WO 2017/163226.
The housing 26 includes a nose portion 40, and a collar 42 spaced apart from the nose portion 40 to define a void space 44 sized to receive the actuator assembly 30. The connecting hub 24 is coupled to and extends proximally from the collar 42. The collar 42 comprises a lip 46 to be described, and further defines an opening 48 sized to receive at least an inner tube 56 of the tube assembly 28. The nose portion 40 may extend generally upwardly from the finger portion 36 and include a proximal surface 50 and a distal surface 52 defining an opening 54 therebetween. The opening 54 is sized to receive the tube assembly 28. The proximal surface 50 may be planar so as to be flush with a distal wheel surface 90 of a wheel 74 of the actuator assembly 30. The distal surface 52 may be contoured in any suitable manner to provide an ergonomic support for digits of the hand of the surgeon, particularly if the housing 26 is grasped in a pencil-grip manner.
The tube assembly 28 includes the inner tube 56, an intermediate tube 58, and an outer tube 60. The intermediate tube 58 is rotatably and coaxially disposed within the outer tube 60, and the inner tube 56 is rotatably and coaxially disposed within the intermediate tube 58. Owing to respective connections with the actuator assembly 30 to be described, the inner tube 56 may be longer than the intermediate tube 58, and the intermediate tube 58 maybe longer than the outer tube 60. The tube assembly 28 may include a bend 62, and a cutting window 64 positioned distal to the bend 62. More particularly, the intermediate tube 58 may be flexible such that the intermediate tube 58 and the outer tube 60 include complementary bends that form the bend 62. Further, the inner tube 56 may also be flexible so as to accommodate the bend 62, for example, during high-speed rotation. The cutting window 64 may be defined by the intermediate tube 58 with the inner tube 56 including cutting features (not shown) configured to be rotatably positioned within the cutting window 64. The cutting features may be teeth arranged about an inner cutting window of a surgical shaver, or a bur head of a surgical bur. The inner tube 56 defines a suction pathway 66 (see
With continued reference to
The wheel 74 is sized to be rotatably positioned within the void space 44 defined by the housing 26. The wheel 74 may include a distal wheel portion 86 and a proximal wheel portion 88. The distal wheel portion 86 includes the distal wheel surface 90, and a first inner wheel surface 92 defining a first cavity 94. The distal wheel portion 86 may further include engagement features 96 disposed within the first cavity 94. The illustrated implementation shows the engagement features 96 as teeth annularly arranged and oriented proximally within the first cavity 94 of the distal wheel portion 90. The proximal wheel portion 88 includes a proximal wheel surface 98, and a second inner wheel surface 100 defining a second cavity 102. The proximal wheel portion 88 may further include engagement features 104 disposed within the second cavity 102. The illustrated implementation shows the engagement features 104 as teeth annularly arranged and oriented distally within the second cavity 102 of the proximal wheel portion 88.
The distal wheel portion 86 and the proximal wheel portion 88 may be discrete components separately formed and secured to one another to form the wheel 74. The distal wheel portion 86 and the proximal wheel portion 88 may include joining features configured to facilitate the assembly of the wheel 74, preferably in a permanent manner in which the distal wheel portion 86 may not be decoupled from the proximal wheel portion 88. The illustrated implementation shows the joining features as barbs 106 (two identified) on the distal wheel portion 86 that are configured to resiliently deflect and engage slots 108 (two identified) defined by the proximal wheel portion 88. The reverse configuration is contemplated, and it is understood that the securing of the distal wheel portion 86 and the proximal wheel portion 88 may be accomplished through other suitable joining means. With the distal wheel portion 86 and the proximal wheel portion 88 secured to one another, the first cavity 94 and the second cavity 102 are sized to accommodate the subcomponents of the actuator assembly 30, namely the first gear 76, the second gear 78, the third gear 80, the biasing member 82, the bearings 84, and the seal 85.
The actuator assembly 30 is selectively operable in at least a first mode and a second mode.
The second gear 78 may be secured to the outer tube 60 at an interface 110, and the third gear 80 may be secured to the intermediate tube 58 at an interface 112. The interfaces 110, 112 may be provided by one or more of adhesive, fasteners, friction fit, interference fit, or the like. Rotation of the second gear 78 rotates the outer tube 60, and therefore the bend 62 of the tube assembly 28 is correspondingly reoriented (arrow 114 of
Several components of the actuator assembly 30 include engagement features to be described that are configured to facilitate selective engagement and disengagement between the subcomponents in the first mode and the second mode. Referring to
The first gear 76 and the second gear 78 may include complementary keying features 126, 128 configured to prevent relative rotation and permit relative translation between the first gear 76 and the second gear 78. The keying feature 126 of the first gear 76 may be at least one rail, and the keying feature 128 on the second gear 78 may be at least one slot. The reverse configuration being contemplated. The illustrated implementation shows two diametrically opposed rails slidably disposed within two diametrically opposed slots defined by a neck 130 of the second gear 78. The first ring 122 of the first gear 76 defines an opening, and the rail is arranged axially within the opening. The neck 130 of the second gear 88 has an outer diameter less than an inner diameter of the opening of the first ring 122 such that the complementary keying features 126, 128 provide for axial translation but not rotation between the first gear 76 and the second gear 78 in each of the first mode and the second mode.
The second gear 78 includes engagement features 132 configured to engage the engagement features 96 of the distal wheel portion 86. The second gear 78 may include a second ring 134 from which the neck 130 extends distally, and the engagement features 132 of the second gear 78 may be teeth annularly arranged and oriented distally about the second ring 134.
The third gear 80 includes engagement features 136 configured to engage the engagement features 104 of the proximal wheel portion 88. The third gear 80 may include a third ring 138, and the engagement features 136 of the third gear 80 may be teeth annularly arranged and oriented proximally about the third ring 138.
The third gear 80 includes a proximal surface 139 positioned in an abutting relationship with a boss 140 extending distally from the collar 42 of the housing 26 (see
Actuation of the actuator assembly 30 in the first mode is described with reference to
Should it be indicated to reorient the bend 62 of the tube assembly 28, the actuator assembly 30 is moved from the first mode to the second mode. To actuate the actuator assembly 30 from the first mode to the second mode, an input is provided to the wheel 74 to move the wheel 74 from the first axial position to the second axial position that is proximal to the first axial position. The input may include manipulating the wheel 74 with a thumb and index finger to pinch and pull the wheel 74 proximally against the spring bias from the biasing member 82. To facilitate ergonomic actuation of the actuator assembly 30 from the first mode to the second mode, the distal wheel portion 86 may include a contour different than a contour of the proximal wheel portion to form a flared surface 148. The flared surface 148 may be considered more vertically oriented to provide for a larger contact area to pinch and pull the wheel 74 with the thumb and the index finger.
With reference to
With the proximal movement of the wheel 74, the first gear 76 disengages from the housing 26, the second gear 78 engages the distal wheel portion 86, and the third gear 80 is disengaged from the proximal wheel portion 88. More particularly, the engagement features 118 of the first gear 76 are disengaged from the engagement features 120 of the housing 26, the engagement features 132 of the second gear 78 are engaged with the engagement features 96 of the distal wheel portion 86, and the engagement features 136 of the third gear 80 are disengaged from with the engagement features 104 of the proximal wheel portion 88. The disengagement and engagement may be simultaneous. Thereafter, rotation of the wheel 74 results in corresponding rotation of the second gear 78, which is secured to the outer tube 60 at the interface 110. Therefore, the rotation of the second gear 78 results in corresponding rotation of the outer tube 60, thereby rotating the tube assembly 28 about the longitudinal axis (arrow 114) and reorienting the bend 62 of the tube assembly 28 about the longitudinal axis.
Once satisfied with the orientation of the bend 62 of the tube assembly 28, the input from the surgeon merely need be released to automatically return the actuator assembly 30 from the second mode to the first mode. The biasing member 82, no longer constrained by the input from the surgeon, biases the first gear 76 distally away from the second gear 78, and the interference engagement between the first gear 76 and the distal wheel portion 86 urges the wheel 74 to move from the second axial position to the first axial position. The distal wheel portion 86, the proximal wheel portion 88, and the first gear 76 move distally, whereas the second gear 78 and the third gear 80 again remain stationary. The first gear 76 engages with the housing 26, the distal wheel portion 86 disengages from the second gear 78, and the proximal wheel portion 88 engages the third gear 80. More particularly, the engagement features 118 of the first gear 76 are engaged with the engagement features 120 of the housing 26, the engagement features 96 of the distal wheel portion 86 are disengage from the engagement features 132 of the second gear 78, and the engagement features 104 of the proximal wheel portion 88 are engaged with the engagement features 136 of the third gear 80. The disengagement and engagement may be simultaneous. Rotational input may be immediately provided to the wheel 74 to further orient the cutting window 64 in view of the reorientation of the bend 62. The cutting assembly 12 of the present disclosure provides an intuitive, ergonomic experience that can efficiently be accomplished with a single hand of the surgeon and without distraction from the surgical site.
The foregoing disclosure is not intended to be exhaustive or limit the invention to any particular form. The terminology which has been used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations are possible in light of the above teachings and the invention may be practiced otherwise than as specifically described. One modification may include providing for adjustment of other features of the cutting assembly 12 through the rotatable input the first mode or the second mode. One example includes adjusting a curvature of the tube assembly with actuation of the actuator assembly 30 in the first mode, the second mode, or another mode. It is further understood that the actuator assembly 30 may be designed to be operable in more than two modes. Another modification may include providing for adjustment of components of a surgical instrument through the rotatable input the first mode or the second mode.
In certain implementations, the cutting assembly 12 may include an audible indicator configured to provide audible (and, in some instances, tactile) feedback to the surgeon when the actuator assembly 30 is moved between the first mode and the second mode. The audible indicator may be configured to provide a “clicking” sound when the wheel 74 returns to the first axial position under the spring bias from the biasing member 82, and/or when the wheel 74 has been moved to the second axial position against the spring bias from the biasing member 82. The clicking sound indicates to the surgeon that the actuator assembly 30 has fully returned to the first mode, or has been successfully moved to the second mode. Examples of the audible indicator may include the housing 26 and the wheel 74 having features or components to provide defeatable interference engagement with one another, such as a resiliently deflectable arm, a detent, a radial spring, a cam, a snap, or the like. The engagement and disengagement of the defeatable features or components may provide the clicking sound. In one variant, the biasing member 82 is optional, and the actuator assembly 30 is configured to be snap locked into the first mode and the second mode. For example, the actuator assembly 30 may provide for the defeatable interference engagement between the housing 26 and the wheel 74 in the first axial position and the second axial position. With the actuator assembly 30 in the first mode, for example, the a first defeatable feature may be overcome with sufficient force applied to the wheel 74. The wheel 74 may be freely movable for most of the distance between the first axial position and the second axial position. Upon encountering the a second defeatable feature associated with the second axial position, sufficient force is again applied to the wheel 74. The wheel 74 is snap locked into the second axial position. The clicking sound may be provided with the actuator assembly 30 snap locked into the first mode and the second mode. In still another example, a button or other input may be provided on the housing 26 and/or the wheel 74 to disengage the defeatable features to permit movement of the wheel 74 between the first axial position and the second axial position. Such arrangements obviate the need for the surgeon to maintain the wheel 74 against the spring bias of the biasing member 82, thereby providing a shorter interaction with less fatigue on the fingers of the surgeon.
In certain implementations, a locking mechanism may be provided to selectively prevent the wheel 74 from rotating relative to the housing 26. For example, the housing 26 may include a locking pin or keyed coupling requiring a user input to disengage the locking mechanism from the wheel 74. One exemplary locking mechanism is disclosed in the aforementioned International Publication No. 2017/163226. In certain implementations, visual indica, such as laser markings, may be provided on the wheel 74, the housing 26, and/or the tube assembly 28 to provide visual information as to the orientation of the bend 62 and/or the orientation of the cutting window 64. For example, the distal wheel portion 86 may be rotatable relative to the proximal wheel portion 88, with the distal wheel portion 86 including a first indicia indicative of the orientation of the bend 62 and the proximal wheel portion 88 including a second indicia indicative of the orientation of the cutting window 64. The first indicia may be an alignment arrow, or a shaped arc to pictorially represent the bend 62 of the tube assembly 28, whereas the second indicia may be an alignment arrow or a shaped oval to pictorially represent the shape of the cutting window 64. In certain implementations, the actuator assembly 30 may be machined in separate parts or molded together. One example includes the distal wheel portion 86 and the proximal wheel portion 88 being integrally formed through a suitable manufacturing processes. It is further contemplated that the housing 26 and the wheel 74 may include different finishes and/or textures to provide a comfortable feel as well as visual indicia of actuatable components of the cutting assembly 12. One exemplary navigation-assisted surgical system suitable with the cutting assembly 12 is disclosed in commonly-owned International Publication No. 2016/066287, published May 6, 2016, the entire contents of which are hereby incorporated by reference.
Additionally, certain inventive aspects of the present disclosure are described with reference to the following exemplary clauses:
Clause 1—A method of operating a surgical cutting assembly including a housing, a tube assembly coupled to the housing and including a bend, and a cutting window positioned distal to the bend, and an actuator assembly including a wheel, and a biasing member, said method comprising the steps of: supporting the housing of the surgical cutting assembly; moving the wheel proximally against spring bias from the biasing member to move the actuator assembly from a first mode to a second mode; and rotating the wheel with the actuator assembly in the second mode to orient the bend of the tube assembly.
Clause 2—The method of clause 1, wherein the step of rotating the wheel further comprises rotating the wheel while maintaining an axial position of the wheel against the spring bias from the biasing member.
Clause 3—The method of any one of clauses 1 and 2, further comprising releasing the wheel to return the actuator assembly including from the second mode to the first mode under the spring bias from the biasing member.
Clause 4—The method of clause 3, wherein the surgical cutting assembly includes an audible indicator, said method further comprising detecting a clicking sound from the audible indicator with the actuator assembly returning to the first mode.
Clause 5—A method of operating a surgical cutting assembly including a housing, a tube assembly coupled to the housing and including a bend, and a cutting window positioned distal to the bend, and an actuator assembly including a wheel, a first interference feature, and a second interference feature, said method comprising the steps of: supporting the housing of the surgical cutting assembly; disengaging the first interference feature with the actuator assembly being in a first mode; moving the wheel proximally to move the actuator assembly from the first mode towards a second mode; engaging the second interference feature to selectively lock the actuator assembly in the second mode; and rotating the wheel with the actuator assembly in the second mode to orient the bend of the tube assembly.
Clause 6—The method of clause 5, wherein the steps of disengaging the first interference feature and engaging the second interference feature further comprise applying a force to the wheel sufficient to overcome the first interference feature and the second interference feature.
Clause 7—The method of any one of clauses 5 and 6, wherein the wheel is freely movable other than the actuator assembly being locked in the first mode and the second mode.
Clause 8—The method of any one of clauses 1-7, wherein the step of moving the wheel proximally further comprising pinching and pulling the wheel with an index finger and a thumb of a hand while the housing of the surgical cutting assembly is supported in a web of the hand.
Clause 9—The method of clause 8, further comprising supporting a web portion of the housing with the web of the hand to provide for single-handed operation of the cutting assembly.
Clause 10—The method of any one of clauses 1-9, further comprising rotating the wheel with the actuator assembly including in the first mode to orient the cutting window of the tube assembly.
Clause 11—The method of any one of clauses 1-10, further comprising coupling the surgical cutting assembly to a capital assembly that includes a motor.
Clause 12—An actuator assembly for a surgical instrument including a housing, said actuator assembly comprising: a wheel defining a cavity; a first gear; a second gear secured to a first subcomponent; and a third gear secured to a second subcomponent, wherein said first gear, said second gear, and said third gear are disposed within said cavity of said wheel.
Clause 13—The actuator assembly of clause 12, wherein at least one of (i) said first gear is configured to be selectively engaged with the housing, (ii) said second gear is configured to be selectively engaged with said wheel, and (iii) said third gear is configured to be selectively engaged with said wheel.
Clause 14—The actuator assembly of clause 12 or 13, wherein said first gear and said second gear comprises complementary features configured to prevent relative rotation and permit relative translation between said first gear and said second gear.
Clause 15—The actuator assembly of any one of clauses 12-14, wherein said actuator assembly further comprises a biasing member disposed between said first gear and said second gear.
Clause 16—The actuator assembly of any one of clauses 12-15, wherein said wheel further comprises a distal wheel portion and a proximal wheel portion being discrete components coupled to one another.
Clause 17—The actuator assembly of any one of clauses 12-16, further comprising an audible indicator disposed on at least one of said housing and said wheel.
Clause 18—The actuator assembly of any one of clauses 12-17, further comprising interference features disposed on at least one of said housing and said wheel, said interference features configured to be selectively engaged and disengaged to permit axial movement of said wheel.
This application claims priority to and all the benefits of U.S. Provisional Patent Application No. 63/178,571, filed Apr. 23, 2021, the entire contents of which are hereby incorporated by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2022/053785 | 4/22/2022 | WO |
Number | Date | Country | |
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63178571 | Apr 2021 | US |