Steerable sheath and adjustable scope attachment

Abstract

A system comprising an adjustable mounting arm, a bronchoscope coupled to the adjustable mounting arm, an attachment coupled to the bronchoscope, and a steerable sheath coupled to the attachment and configured to be inserted through the bronchoscope, The system further includes a flexible probe configured to be inserted through the steerable sheath and the bronchoscope.

Description

[Technical field]

[0001] The present disclosure relates to endoscope accessories, and more particularly to bronchoscope accessories. The devices described herein find use in a variety of endoscopic (e.g., bronchoscope) applications. [Background technology]

[0002] Precise placement of catheters, probes, and other tools is important in many medical procedures. For example, precise placement of an ablation probe is important for transbronchial pulmonary ablation or local drug delivery. Robotic systems can aid in precise placement, but are often cost-prohibitive. Medical procedures using conventional endoscopic systems involve several devices, and a single user has difficulty holding and manipulating all the devices in a conventional system. Summary of the Invention [Means for solving the problem]

[0003] The present disclosure provides, in one aspect, a bronchoscope attachment including a mount having a port and a cradle defining an insertion axis. The insertion axis is aligned with the port. The bronchoscope attachment further includes a linkage positioned between the mount and the cradle. The linkage is movable between a first position in which the cradle is positioned a first distance from the port and the insertion axis is aligned with the port, and a second position in which the cradle is positioned a second distance from the port and the insertion axis is aligned with the port.

[0004] In some embodiments, the insertion axis remains aligned with the port in response to movement of the linkage.

[0005] In some embodiments, the linkage includes a first arm, a second arm, and an elbow coupled between the first arm and the second arm.

[0006] In some embodiments, a first end of the first arm is pivotally coupled to the mount and a second end of the first arm is pivotally coupled to the elbow.

[0007] In some embodiments, a first end of the second arm is coupled to the cradle and a second end of the second arm is pivotally coupled to the elbow.

[0008] In some embodiments, the elbow includes a first gear coupled to the first arm and a second gear coupled to the second arm.

[0009] In some embodiments, the first gear meshes with the second gear.

[0010] In some embodiments, the first arm includes a first link and a second link, and the second arm includes a third link and a fourth link.

[0011] In some embodiments, the second link and the third link are rotatably coupled together by a gear set positioned within the elbow.

[0012] In some embodiments the second arm moves in response to movement of the first arm and the first arm moves in response to movement of the second arm.

[0013] In some embodiments, the linkage is a telescoping slide.

[0014] In some embodiments, the mount includes a base portion, a door, and a latch.

[0015] In some embodiments, the mount includes a first opening partially defined by the door and a second opening at least partially defined by the door, the first opening being aligned with the second opening.

[0016] In some embodiments, the port is formed in the base portion.

[0017] In some embodiments, the door is movable relative to the base portion between an open position and a closed position.

[0018] In some embodiments, the cradle remains in a fixed position in response to the door moving to the open position.

[0019] In some embodiments, the latch is actuated to lock the door in a closed position.

[0020] In some embodiments, the bronchoscope attachment further includes a seal coupled to the port.

[0021] In some embodiments, the mount is rotatable relative to the bronchoscope.

[0022] In some embodiments, the port remains in place when the mount rotates about the port.

[0023] The present disclosure provides, in one aspect, a steerable sheath including a handle having a housing, a port formed on the housing, and a user input wheel rotatably coupled to the housing. The steerable sheath further includes a sheath extending from the handle. The sheath includes a proximal end coupled to the handle and a distal end. The steerable sheath includes a transmission coupled between the user input wheel and the distal end of the sheath, such that actuation of the user input wheel articulates the distal end of the sheath.

[0024] In some embodiments, the distal end is curved at an angle with the user-input wheel in a neutral position.

[0025] In some embodiments, the steerable sheath further includes a detent positioned within the housing, the detent engaging the transmission with the user input wheel in a neutral position.

[0026] In some embodiments, the angle is 70°.

[0027] In some embodiments, the user input wheel includes a first indicator that is visible when the user input wheel is in a neutral position and a second indicator that is visible when the user input wheel is in a non-neutral position.

[0028] In some embodiments, the steerable sheath further includes a brake assembly that adjusts the amount of frictional engagement between the housing and the user input wheel.

[0029] In some embodiments, the user input wheel includes a hub positioned about a boss formed on the housing, and the brake assembly includes a sleeve positioned about the boss. The brake assembly further includes a spring washer positioned between the sleeve and the hub and a fastener for securing the sleeve to the boss. The sleeve is adjustably positioned relative to the hub, and the brake assembly maintains the position of the user input wheel when the user input wheel is released by the user.

[0030] In some embodiments, the port is connected to the sheath and an obturator is inserted through the port.

[0031] In some embodiments, the user input wheel rotates about an axis that intersects the sheath axis. The longitudinal axis of the handle is aligned with the sheath axis.

[0032] In some embodiments, the handle includes a circumferential groove on an outer surface of the housing, the housing including a tapered end, and the proximal end of the sheath is coupled to the tapered end.

[0033] In some embodiments, the transmission includes a drive gear, a belt coupled between the user input wheel and the drive gear, a first rack in mesh with the drive gear, a second rack in mesh with the drive gear, and a first pull wire coupled to the first rack. Actuation of the first pull wire articulates the distal end of the sheath.

[0034] In some embodiments, the transmission further includes a second pull wire coupled to the second rack, actuation of the second pull wire articulating the distal end of the sheath.

[0035] In some embodiments, the first rack and the second rack translate relative to the drive gear in response to rotation of the user input wheel. In some embodiments, the housing includes a first slot that at least partially receives the first rack and a second slot that at least partially receives the second rack such that the first rack and the second rack are slidable relative to the housing.

[0036] In some embodiments, the user input wheel is positioned within the handle with a first exposed portion and a second exposed portion, and the housing is positioned between the first exposed portion and the second exposed portion.

[0037] In some embodiments, the user input wheel is rotatably coupled to the housing about an axis aligned with the longitudinal axis of the housing, and the user input wheel is an actuation ring.

[0038] In some embodiments, the user input wheel is spaced from the proximal end of the housing.

[0039] In some embodiments, the transmission includes a linkage coupled to the user-input wheel by a pin and a helical slot, the linkage translating linearly in response to rotation of the user-input wheel.

[0040] In some embodiments, the transmission includes a planetary gear assembly and a power screw.

[0041] In some embodiments, the transmission includes a pawl.

[0042] In some embodiments, the transmission includes at least one electrical component, the electrical component being a sensor, an actuator, a power source, or a controller.

[0043] The present disclosure, in one aspect, provides a system that includes an adjustable mounting arm, a bronchoscope coupled to the adjustable mounting arm, an attachment coupled to the bronchoscope, and a steerable sheath coupled to the attachment and configured to be inserted through the bronchoscope.

[0044] In some embodiments, the system further includes a flexible probe configured to be inserted through the steerable sheath and the bronchoscope.

[0045] In some embodiments, the flexible probe is a microwave ablation probe.

[0046] In some embodiments, the system further comprises a local agent delivery device configured to be inserted through the steerable sheath and the bronchoscope.

[0047] In some embodiments, the attachment includes a mount having a port and a cradle defining an insertion axis. The insertion axis is aligned with the port. The attachment further includes a linkage positioned between the mount and the cradle. The linkage is movable between a first position, where the cradle is positioned a first distance from the port and the insertion axis is aligned with the port, and a second position, where the cradle is positioned a second distance from the port and the insertion axis is aligned with the port.

[0048] In some embodiments, the port on the mount receives a port formed on the bronchoscope.

[0049] In some embodiments, the mount includes a first opening and a second opening aligned with the first opening, and the bronchoscope extends through the first opening and the second opening.

[0050] In some embodiments, the steerable sheath is releasably coupled to the cradle.

[0051] In some embodiments, the steerable sheath includes a handle including a housing, a port formed on the housing, and a user input wheel rotatably coupled to the housing. The steerable sheath further includes a sheath extending from the handle. The sheath includes a proximal end and a distal end coupled to the handle. The steerable sheath further includes a transmission coupled between the user input wheel and the distal end of the sheath. Actuation of the user input wheel articulates the distal end of the sheath.

[0052] Other aspects of the disclosure will become apparent by consideration of the detailed description and accompanying drawings. [Brief description of the drawings]

[0053] The accompanying drawings and examples are provided for purposes of illustration and not for purposes of limitation. The foregoing aspects and other features of the present disclosure are described in the following description taken in conjunction with the accompanying illustrative drawings (also "Figures") in connection with one or more embodiments. This patent or application document contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. [Figure 1] FIG. 1 is a perspective view of a system for use in an endoscopic procedure. [Diagram 2] FIG. 2 is a side view of an adjustable mounting arm. [Diagram 3] FIG. 1 is a perspective view of a system for use in an endoscopic procedure. [Figure 4] FIG. 3 is a partial perspective view of a gooseneck dock removably attached to the adjustable mounting arm of FIG. 2. [Diagram 5] FIG. 1 is a partial perspective view of a system for use in an endoscopic procedure. [Figure 6] FIG. 2 is a side view of a bronchoscope attachment and a steerable sheath coupled to a bronchoscope. [Figure 7] FIG. 7 is a perspective view of FIG. 6, with the bronchoscope attachment rotated relative to the bronchoscope. [Figure 8] FIG. 1 is a partial perspective view of a system for use in an endoscopic procedure. [Figure 9] FIG. 2 is a perspective view of a bronchoscope attachment and steerable sheath, with the bronchoscope shown in phantom. [Figure 10] FIG. 10 is a perspective view of the bronchoscope attachment of FIG. [Figure 11A] FIG. 10 is a perspective view of the bronchoscope attachment of FIG. 9 , separated from the bronchoscope. [Figure 11B] 10 is a partial perspective view of the bronchoscope attachment of FIG. 9 supported on a bronchoscope in a partially installed configuration. [Figure 12] FIG. 10 is a cross-sectional view of the bronchoscope attachment of FIG. [Figure 13A] FIG. 1 is a side view of the system with the bronchoscope attachment and steerable sheath in a first position. [Figure 13B] FIG. 13B is a side view of the system of FIG. 13A with the bronchoscope attachment and steerable sheath in a second position. [Figure 14] FIG. 2 is a side view of a steerable sheath. [Figure 15] FIG. 15 is a partial perspective view of the steerable sheath of FIG. [Figure 16A] FIG. 13 is a partial perspective view of the steerable sheath with the user input wheel in a neutral position. [Figure 16B] FIG. 13 is a partial perspective view of the steerable sheath with the user input wheel in an actuated position. [Figure 16C] FIG. 13 is a partial perspective view of the steerable sheath with the obturator removed from the port. [Figure 17] FIG. 2 is a perspective view of a steerable sheath. [Figure 18] FIG. 2 is a perspective view of a steerable sheath. [Figure 19] FIG. 2 is a perspective view of a steerable sheath. [Figure 20] FIG. 15 is a partial side view of the steerable sheath of FIG. 14 with parts removed for clarity. [Figure 21] FIG. 15 is another partial side view of the steerable sheath of FIG. 14 with portions removed for clarity. [Figure 22] FIG. 15 is an exploded view of the steerable sheath of FIG. [Figure 23] FIG. 15 is a partial cross-sectional view of the steerable sheath of FIG. [Figure 24] FIG. 15 is a perspective cross-sectional view of the steerable sheath of FIG. [Diagram 25] FIG. 2 is a side view of a steerable sheath with a transmission, shown partially in transparent form. [Figure 26] FIG. 1 is a perspective view of a steerable sheath with a transmission, with parts removed for clarity. [Figure 27] FIG. 2 is a partial perspective cross-sectional view of a steerable sheath with portions removed for clarity, the steerable sheath having a transmission. [Figure 28] 1A and 1B are perspective and enlarged views of a flexible probe inserted into a sheath. [Figure 29] FIG. 13 is a perspective view of an anti-buckling device coupled to a flexible probe that is inserted into a sheath. [Diagram 30] FIG. 30 is a partial perspective view of the anti-buckling device of FIG. 29, shown partially transparent for clarity.

[0054] Before any embodiment is described in detail, it is to be understood that the invention is not limited in its application to the construction or arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or carried out in various ways. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0055] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art. In case of conflict, the present document, including definitions, governs. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in the practice or testing of this disclosure. All publications, patent applications, patents, and other references mentioned herein are incorporated herein by reference in their entirety. The materials, methods, and examples disclosed herein are illustrative only and are not intended to be limiting.

[0056] The terms "comprise," "include," "having," "has," "can," "contain," and variations thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that do not preclude the possibility of additional acts or structures. Unless the context clearly dictates otherwise, the singular forms "a," "an," and "the" include plural referents. The present disclosure also contemplates other embodiments that "comprise," "consist," and "consist essentially of" the embodiments or elements presented herein, whether or not expressly stated.

[0057] For the recitation of numerical ranges herein, each intervening number is expressly contemplated to the same degree of precision. For example, for the range 6 to 9, the numbers 7 and 8 are contemplated in addition to 6 and 9, and for the range 6.0 to 7.0, the numbers 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, and 7.0 are expressly contemplated.

[0058] As used herein, "coupled" refers to two or more components secured together by any suitable means. Thus, in some embodiments, a statement that two or more parts or components are "coupled" is intended to mean that the parts are joined or operate together directly or indirectly, for example, through one or more intermediate parts or components.

[0059] As used herein, "removably coupled" means that one component is coupled to another component in an essentially temporary manner. That is, the two components are coupled in such a way that joining or separating the components is easy and does not damage the components. Thus, "removably coupled" components can be easily separated and recoupled without damaging the components.

[0060] As used herein, "operably coupled" means that several elements or assemblies, each of which is movable between a first position and a second position or configuration, are coupled such that movement of the first element from one position / configuration to the other position / configuration causes the second element to also move between positions / configurations. Note that a first element may be "operably coupled" to another element without vice versa.

[0061] Therapeutic or interventional endoscopy relates to endoscopic procedures in which a treatment (e.g., tissue ablation) (e.g., tissue sampling) is performed via an endoscope. This contrasts with diagnostic endoscopy, where the purpose of the procedure is purely to visualize the interior of the body (e.g., gastrointestinal, respiratory, urinary tract, etc.) to aid in diagnosis. In fact, a procedure that begins as a diagnostic endoscopy may become a therapeutic endoscopy depending on the findings.

[0062] In general, therapeutic endoscopy involves applying an endoscope ("primary catheter") to a body region until a natural stopping position is reached (e.g., until the circumference of the body region prevents further advancement of the endoscope). A flexible sheath having a circumference smaller than the circumference of the endoscope is then advanced through the endoscope to the desired body region location. A therapeutic or diagnostic tool (e.g., an ablation energy delivery tool) (e.g., a tissue sampling tool) (e.g., a biopsy needle) having a circumference smaller than the diameter of the flexible sheath is then advanced through the flexible sheath to the desired body region location. Ablative energy is then delivered to the desired body region location. Once therapeutic endoscopy is completed, the ablation energy delivery tool is withdrawn through the flexible sheath, the flexible sheath is withdrawn through the endoscope, and the endoscope is withdrawn from the subject.

[0063] Referring to FIG. 1, a system 10 for performing an endoscopic procedure on a patient 14 is illustrated. The system 10 includes an adjustable mounting arm 18 coupled to a patient bed 22 and a bronchoscope 26 coupled to the adjustable mounting arm 18. An attachment 30 (i.e., a bronchoscope attachment, support arm) is coupled to the bronchoscope 26, and a steerable sheath 34 is coupled to the attachment 30. As described in more detail herein, the steerable sheath 34 is configured to be inserted through the bronchoscope 26, and a flexible probe 38 (e.g., a microwave ablation probe) is configured to be inserted through the steerable sheath 34 and the bronchoscope 26. In some embodiments, a medical imaging device 40 (e.g., x-ray, fluoroscopy, CT, etc.) is utilized in conjunction with the system 10 to aid in positioning the bronchoscope 26, the steerable sheath 34, and the flexible probe 38 within the patient 14. Although system 10 is illustrated with a bronchoscope 26, the systems disclosed herein may be utilized with any type of endoscope or "scope."

[0064] 2 and 3, the adjustable mounting arm 18 includes a base rail attachment 42 that allows a user to place the adjustable mounting arm 18 on a bedside surgical rail 46. In some embodiments, the base rail attachment 42 includes a clamp 50 and a knob 54 for adjusting the clamp 50. For example, a user can loosen the knob 54, place the clamp 50 on the bedrail 46, and tighten the knob 54 to secure the clamp 50 and adjustable mounting arm 18 to the bedrail 46.

[0065] 2, the adjustable mounting arm 18 includes a first member 58 and a second member 62 rotatably coupled by an adjustable elbow 66. The adjustable elbow 66 includes a knob 70 for releasably locking the adjustable elbow 66 in a desired position. For example, a user can loosen the knob 70, articulate the adjustable elbow 66 to position the first and second members 58, 62 in a desired position, and tighten the knob 70 to secure the adjustable elbow 66 and members 58, 62 in place.

[0066] 2, the adjustable mounting arm 18 includes a bronchoscope claw 74 having a plurality of gripping fingers 78. The bronchoscope claw 74 is configured to receive the bronchoscope 26 and hold it in place relative to the adjustable mounting arm 18. For example, the bronchoscope claw 74 is opened by a user and positioned around the bronchoscope 26 (e.g., a bronchoscope handle) to easily dock the bronchoscope 26 onto the adjustable mounting arm 18. In some embodiments, the plurality of gripping fingers 78 include a non-scratch coating to prevent damage to the bronchoscope 26.

[0067] In operation, the adjustable mounting arm 18 is attached to the bedrail 46 and the bronchoscope 26 is clipped within the bronchoscope claw 74. The relative position of the first member 58 and the second member 62 can then be adjusted by moving the adjustable elbow 66. In that way, the bronchoscope 26 is supported in various positions relative to the bedrail 46 by the adjustable mounting arm 18. In some embodiments, the claw 74 is aligned with the patient's mouth to help prevent bending of the bronchoscope.

[0068] 3, in some embodiments, the adjustable mounting arm 18 includes a support bracket 82 for holding a power distribution module (PDM) 86 for the flexible ablation probe 38 on the adjustable mounting arm 18 in proximity to the bronchoscope 26. In some embodiments, the power distribution module 86 is removably coupled to the support bracket 82 using a dovetail slot configuration. In some embodiments, the support bracket 82 includes a magnet 90 that helps hold the power distribution module 86 in place relative to the support bracket 82. In the illustrated embodiment, the power distribution module 86 includes a power cord 94 extending therefrom. The power distribution module 86 is configured to be electrically coupled to the flexible ablation probe 38. In some embodiments, the power distribution module 86 controls the microwave energy emitted from the flexible probe 38.

[0069] 3, the flexible ablation probe 38 includes a plug 98 electrically coupled to the power distribution module 86. In the illustrated embodiment, the plug 98 includes key features to ensure proper orientation of the plug 98 relative to the power distribution module 86. In some embodiments, the flexible probe 38 is then inserted directly into the bronchoscope 26 (FIG. 3). In the illustrated embodiment, the flexible probe 38 is inserted into a port 102 formed on the bronchoscope 102. In some embodiments, the flexible ablation probe 38 can provide treatment by delivering microwave energy to a targeted tumor.

[0070] 4, in some embodiments, the adjustable mounting arm 18 includes a support bracket 106 for a gooseneck dock 110. In the illustrated embodiment, the gooseneck dock 110 includes a mount 114 removably coupled to the support bracket 106 at a first end 118 and a cradle 122 for supporting a steerable sheath or other tool at a second end 126. In some embodiments, the cradle 122 is configured to support a variety of endoscopic tools or treatment devices. In some embodiments, the mount 114 is removably coupled to the support bracket 106 using a dovetail configuration. In some embodiments, the dovetail configuration is the same as the dovetail configuration for attaching the power distribution module 86 to the support bracket 82.

[0071] The flexible member 130 extends between the mount 114 and the cradle 122, the flexible member 130 is repositionable by a user, and the flexible member 130 retains its shape and position when released by the user. In other words, the flexible member 130 is strong enough to support a tool (e.g., a steerable sheath) in various positions and orientations, and can be manipulated with one hand to move the cradle 122 and tool to different locations.

[0072] 5, the cradle 122 includes a magnetic mount 134 that magnetically couples to the steerable sheath 138. In the illustrated embodiment, the steerable sheath 138 includes an iron portion 142 (i.e., an iron sleeve) that is magnetically attracted to the magnetic mount 134. The magnetic mount 134 allows a user to perform finite position manipulations (e.g., rotation, insertion, sifting, etc.) of the steerable sheath 138 while the steerable sheath 138 remains coupled to the cradle 122. The cradle 122 stabilizes the steerable sheath 138 for insertion into the bronchoscope 26. Advantageously, the gooseneck dock 110 supports the steerable sheath 138 while it is positioned within the bronchoscope 26. The gooseneck dock 110 is scope agnostic (i.e., it can work with any type of endoscope) and can hold tools in various positions and orientations relative to the scope.

[0073] 6, a system 146 is illustrated having a bronchoscope 26, a steerable sheath 150, and a bronchoscope attachment 154. In the illustrated embodiment, the bronchoscope attachment 154 includes a mount 158 ​​with a port 162 (e.g., an opening) that corresponds to the port 102 on the bronchoscope 26. The bronchoscope attachment 154 further includes a cradle 166 that defines an insertion axis 170. In the illustrated embodiment, the insertion axis 170 of the cradle 166 is aligned with an insertion axis 174 of the port 102 on the bronchoscope 26.

[0074] 6, the bronchoscope attachment 154 includes a linkage 178 positioned between the mount 158 ​​and the cradle 166. As described in more detail herein, the linkage 178 is movable between a first position in which the cradle 166 is positioned a first distance from the port 102 and the insertion axis 170 is aligned with the insertion axis 174 of the port 102, and a second position in which the cradle 166 is positioned a second distance from the port 102 and the insertion axis 170 is aligned with the insertion axis 174 of the port 102. In other words, the linkage 178 is movable to adjust the distance the cradle 166 is positioned from the port 102 while keeping the insertion axis 170 of the cradle 166 aligned with the port 102. In that way, the insertion axis 170 remains aligned with the insertion axis 174 of the port 102 in response to movement of the linkage 178.

[0075] 6, the linkage 178 includes a first link 182, a second link 186, a third link 190, and a fourth link 194. At a first end 198, the first link 182 and the second link 186 are coupled to the mount 158. At a second end 202 opposite the first end 198, the first link 182 and the second link 186 are coupled to an elbow 206. At a first end 210, the third link 190 and the fourth link 194 are coupled to the cradle 166. At a second end 214 opposite the first end 210, the third link 190 and the fourth link 194 are coupled to the elbow 206. In the illustrated embodiment, the elbow 206 includes a first gear 218 coupled to the second link 186 and a second gear 222 coupled to the third link 190, such that the second and third links 186, 190 are rotatably coupled to one another. In the illustrated embodiment, the first gear 218 is integrally formed with the second link 186 and the second gear 222 is integrally formed with the third link 190. Advantageously, the third and fourth links 190, 194 move in response to movement of the first and second links 182, 186 (and vice versa), thereby changing the distance between the cradle 166 and the bronchoscope 26 while maintaining the insertion axis 170 aligned with the port 102 on the bronchoscope 26.

[0076] 7, in the illustrated embodiment, the mount 158 ​​of the bronchoscope attachment 154 is rotatable relative to the bronchoscope 26. In other words, the bronchoscope attachment 154 is rotatable about an insertion axis 170 and an insertion axis 174 that extend through the ports 162, 102, respectively. The port 162 on the mount 158 ​​remains in place as the mount 158 ​​rotates about the port 162. Advantageously, the bronchoscope attachment 154 can be rotated about the insertion axes 170, 174 by a user during a procedure as desired.

[0077] 8, a system 226 is shown having an adjustable mounting arm 18, a bronchoscope attachment 230, a steerable sheath 150, and a bronchoscope 26. The bronchoscope attachment 230 includes a mount 234, a cradle 238, and a linkage 242, which is a telescoping slide extending between the mount 234 and the cradle 238. In the illustrated embodiment, the linkage 242 includes a first slide member 246 and a second slide member 250, which are slidable relative to one another to position the cradle 238 at various distances from the bronchoscope 26 while maintaining alignment of an insertion axis 254 of the cradle 238 with the insertion axis 174 of the bronchoscope port 102.

[0078] 9, a system 258 is shown having a bronchoscope 26, a bronchoscope attachment 262 (i.e., support arm, symmetric arm), and a steerable sheath 266. The bronchoscope attachment 262 includes a mount 270 having a port 274 that corresponds to the port 102 on the bronchoscope 26. The bronchoscope attachment 262 further includes a cradle 278 that defines an insertion axis 282 that is aligned with the insertion axis 174 of the port 102. A linkage 286 is positioned between the mount 270 and the cradle 278. The linkage 286 is movable between a first position ( FIG. 13A ) in which the cradle 278 is positioned a first distance 290 from the port 102 and the insertion axis 282 is aligned with the insertion axis 174 of the port 102, and a second position ( FIG. 13B ) in which the cradle 278 is positioned a second distance 294 from the port 102 and the insertion axis 282 is aligned with the insertion axis 174 of the port 102. In other words, the linkage 286 is movable to adjust the distance that the cradle 278 is positioned from the port 102 on the bronchoscope 26 while keeping the insertion axis 282 aligned with the port 102. In that way, the insertion axis 282 of the cradle 278 remains aligned with the insertion axis 174 of the port 102 in response to movement of the linkage 286.

[0079] Advantageously, the bronchoscope attachments disclosed herein (e.g., bronchoscope attachments 154, 230, 262) allow a single user to hold and operate both the bronchoscope and the steerable sheath as a single unit with one hand. The bronchoscope attachments solve the problem of needing multiple operators to control various devices during a medical procedure. The bronchoscope attachments can be attached to the bronchoscope with one hand. The bronchoscope attachments maintain the position and distance of the sheath relative to the bronchoscope working channel port. The cradle provides a snap-fit ​​design for easy click-in and click-out of the steerable sheath. The bronchoscope attachments also reduce the chance of sheath kinking because the insertion axis remains aligned. In some embodiments, the bronchoscope attachments are configured to support various endoscopic tools or treatment devices. In some embodiments, the bronchoscope attachments are coupled to an adjustable mounting arm 18.

[0080] 10 and 12, the linkage 286 includes a first arm 298, a second end 302, and an elbow 306 coupled between the first arm 298 and the second arm 302. A first end 310 of the first arm 298 is pivotally coupled to the mount 270, and a second end 314 of the first arm 298 is pivotally coupled to the elbow 306. A first end 318 of the second arm 302 is coupled to the cradle 278, and a second end 322 of the second arm 302 is pivotally coupled to the elbow 306. In the illustrated embodiment, the elbow 306 includes a first gear 326 coupled to the first arm 298 and a second gear 330 coupled to the second arm 302. In the illustrated embodiment, the first gear 326 meshes with the second gear 330.

[0081] 12 , the first arm 298 includes a first link 334 and a second link 338, and the second arm 302 includes a third link 342 and a fourth link 346. In the illustrated embodiment, the second link 338 and the third link 342 are rotatably coupled together by a gear set 350 (i.e., a first gear 326 and a second gear 330) positioned within the elbow 306. In the illustrated embodiment, the first gear 326 is integrally formed with the second link 338, and the second gear 330 is integrally formed with the third link 342. As such, the second arm 302 moves in response to the movement of the first arm 298, and the first arm 298 moves in response to the movement of the second arm 302. The linkage 286 allows for smooth insertion and retraction of the steerable sheath 266 while maintaining the same insertion trajectory along the insertion axis 174 (i.e., the insertion axis 282 remains aligned with the insertion axis 174). For example, the operator can pull the second arm 302 or cradle 278 to retract the steerable sheath 266 from the bronchoscope 26, or push down the second arm 302 or cradle 278 to insert the steerable sheath 266 into the bronchoscope 26, while maintaining the alignment of the axes 282, 174).

[0082] 10, 11A, and 11B, the mount 270 is a collar having a base portion 354 and a door 358 movable relative to the base portion 354 between an open position (FIGS. 11A and 11B) and a closed position (FIGS. 9 and 10). The mount 270 further includes a latch 362 for selectively locking the door 358 in the closed position. In the illustrated embodiment, the latch 362 is actuated by a user to lock the door 358 in the closed position. In some embodiments, the mount 270 at least partially wraps around the bronchoscope 26. In the illustrated embodiment, when the door 358 is in the closed position, the base portion 354 and the door 358 together completely wrap around the bronchoscope 26. The mount 270 includes a first opening 366 defined in part by the door 358 and a second opening 370 defined in part by the door 358. In the illustrated embodiment, the first opening 366 is aligned with the second opening 370, and both openings 366, 370 are configured to receive the bronchoscope 26 such that the bronchoscope 26 extends through both the first opening 366 and the second opening 370.

[0083] 9 and 10, the port 274 of the mount 270 is formed in the base portion 354. In the illustrated embodiment, the port 274 is an opening configured to receive the port 102 of the bronchoscope 26. In other words, the port 102 on the bronchoscope 26 extends through the port 274 of the mount 270. In some embodiments, a seal is coupled to the port 274 and / or the port 102 to create a seal around any tool or instrument inserted into the bronchoscope 26. In other words, the seal creates an airtight seal around a device inserted into the bronchoscope 26, allowing an operator to act immediately in response to an emergency without requiring disassembly of the bronchoscope attachment 262.

[0084] Advantageously, the bronchoscope attachment 262 is configured to stationary (i.e., supported, dangling, etc.) the bronchoscope 26 during installation of the bronchoscope attachment 262. In other words, after the mount 270 is coupled to the bronchoscope 26 such that the port 102 extends through the port 274, the bronchoscope attachment 262 is supported on the bronchoscope 26 such that the operator can release the bronchoscope attachment 262 and the bronchoscope attachment 262 will remain in place. As such, the bronchoscope attachment 262 is partially attached to the bronchoscope 26 with the door 358 in the open position (moving from FIG. 11A to FIG. 11B ), and then the bronchoscope attachment 262 is fully supported on the bronchoscope 26. Advantageously, the bronchoscope attachment 262 is more easily attached to the bronchoscope 26, requiring fewer operator hands. For example, an operator can place (or partially place) the bronchoscope attachment 262 on the bronchoscope 26 with one hand, either before or after navigation of the bronchoscope 26. The door 358 is then moved to a closed position and the latch 362 is actuated to secure the door 358 in the closed position and secure the bronchoscope attachment 262 to the bronchoscope 26. To remove the bronchoscope attachment 262 from the bronchoscope 26, the latch 362 is actuated to release the door 358 and allow the door 358 to move from the closed position to the open position. The base portion 354, the linkage 286, and the cradle 278 remain in place in response to the door 358 moving from the closed position to the open position. In other words, the bronchoscope attachment 262 remains supported on the bronchoscope 26 when the door 358 is moved to the open position.

[0085] 14, the steerable sheath 266 includes a handle 374 having a housing 378, a port 382 formed on the housing 378, and a user input wheel 386 rotatably coupled to the housing 378. A sheath 390 extends from the housing 378 and includes a proximal end 394 coupled to the handle 374 and a distal end 398 opposite the proximal end 394. The distal end 398 is articulated by user actuation of the user input wheel 386, with two articulation positions shown in phantom in FIG. 14. A transmission 402 is coupled between the user input wheel 386 and the distal end 398 of the sheath 390, such that actuation of the user input wheel 386 articulates the distal end 398 of the sheath 390. In the illustrated embodiment, the sheath 390 is a pre-curved sheath such that the distal end 398 is curved at an angle 406 while the user input wheel 386 is in a neutral position. In some embodiments, the angle 406 is within a range of about 45 degrees to about 180 degrees. In some embodiments, the angle 406 is about 70 degrees. In some embodiments, the pre-curve allows for airway navigation without the need to articulate first. In some embodiments, articulation of the distal end with the pre-curve (i.e., articulation in the same direction as the pre-curve) allows for a greater amount of articulation in the direction of the pre-curve.

[0086] 9 and 15, the handle 374 of the steerable sheath 266 is snap-fitted into the cradle 278. In other words, the steerable sheath 266 is releasably coupled to the cradle 278. In the illustrated embodiment, the handle 374 includes a circumferential groove 410 on an outer surface 414 of the housing 378. In the illustrated embodiment, the circumferential groove 410 extends 360° around the outer surface 414 of the housing 378. In other embodiments, the circumferential groove 410 extends less than 360° around the housing 378. The housing 378 includes a tapered end 418, and the proximal end 394 of the sheath 390 is coupled to the tapered end 418. As such, the cradle 278 is configured to hold the steerable sheath 266 in place during navigation, imaging, confirmation, and ablation. The sheath 390 can be rotated, articulated, and inserted into and retracted from the bronchoscope 26 all the while remaining docked within the cradle 278.

[0087] For example, accurate positioning of the flexible probe 38 when used for pulmonary ablation is difficult with conventional sheaths and extended working channels that are primarily static with pre-curved ends that straighten during insertion of the probe or tool. Conventional sheaths do not provide a means to change the trajectory of the probe once placed through the sheath and therefore may become dependent on the patient's airway structure to access the target lesion. Advantageously, the steerable sheaths disclosed herein (e.g., steerable sheaths 34, 138, 150, 266, 434, 458, 482, 582, 642, 690) improve precision and control over the positioning of the flexible probe 38. The steerable sheaths can be steered via articulation pull wires and can operate with or without a bronchoscope. The steerable sheaths allow for one-handed use to control insertion and / or removal, rotation, and articulation in two or more directions. The steerable sheaths facilitate use in a vertical position for pulmonary surgery as opposed to a horizontal position for sheaths used in cardiac surgery. In some embodiments, the steerable sheath may include axial symmetry to allow the steerable sheath to be docked to the cradle and still rotate relative to the cradle. The steerable sheath does not require a robotic platform, which may be cost prohibitive. In some embodiments, the steerable sheath is utilized to place other endoscopic tools, therapeutic devices, biopsy devices, or local drug delivery devices. In some embodiments, the system includes a steerable sheath and a local drug delivery device (e.g., a flexible needle) configured to be inserted through a bronchoscope. In some embodiments, the system includes a steerable sheath and a diagnostic biopsy tool configured to be inserted through a bronchoscope.

[0088] 15, the user input wheel 386 is rotatable about an axis 422 that intersects with a sheath axis 426 defined by the sheath 390. In the illustrated embodiment, the axis 422 is perpendicular to the sheath axis 426. In the illustrated embodiment, the sheath axis 426 is also the longitudinal axis of the handle 374.

[0089] 17, a handle 430 for a steerable sheath 434 is illustrated. The handle 430 includes a housing 438 and a user input wheel 442 rotatably coupled to the housing 438 about an axis 446 aligned with a longitudinal axis 450 of the handle 430 (which in the illustrated embodiment is also the sheath axis). In the illustrated embodiment, the user input wheel 442 is an actuator ring that wraps 360° around the outer periphery 454 of the housing 438.

[0090] 18, a handle 454 for a steerable sheath 458 is illustrated. The handle 454 includes a housing 462 and a user input wheel 466 positioned within the housing 462 having a first exposed portion 470 and a second exposed portion 474. The housing 462 is located between the first exposed portion 470 and the second exposed portion 474. In other words, the user input wheel 466 extends from the housing 462 in two separate locations, with a portion of the housing 462 separating the two portions 470, 474.

[0091] 19, a handle 478 for the steerable sheath 482 is illustrated. The handle 478 includes a user input wheel 486 that is rotatably coupled to a housing 490. In the illustrated embodiment, the user input wheel 486 is spaced from a proximal end 494 of the housing 490 and extends from a top surface 498 of the housing 490.

[0092] 16A-16C, the user input wheel 386 of the steerable sheath 266 includes a first indicator 502 that is visible when the user input wheel 386 is in a neutral position (FIG. 16A) and a second indicator 506 that is visible when the user input wheel 386 is in a non-neutral position (FIG. 16B). In other words, the first indicator 502 provides an indication to the operator that the distal end 398 of the sheath 390 is in a neural position. In the illustrated embodiment, the first indicator 502 aligns with a corresponding rib 510 formed on the housing 378 when the distal end 398 of the sheath 390 is in the neutral position. As detailed herein, in some embodiments, the distal end 398 of the sheath 390 is curved in the neutral position. The second indicator 506 provides an indication to the operator that the distal end 398 of the sheath 390 is in an actuated position. In the illustrated embodiment, the second indicator 506 is a contrasting color (e.g., red) to alert the operator that the distal end 398 has been actuated, for example, before the operator attempts to partially or fully withdraw or retract the steerable sheath 266 from the bronchoscope 26. For example, before performing an ablation, the sheath distal end should be retracted from the planned ablation zone.

[0093] The obturator 514 can be inserted through a port 382 on the handle 374 and into the sheath 390, for example, to aid in positioning the sheath 390 within the bronchoscope 26. With reference to FIG. 23, the port 382 is connected to the sheath 390. In some embodiments, a friction fit holds the obturator 514 in place. The obturator 514 can be removed from the port 382 (FIG. 16C). Once the obturator 514 is removed, the port 382 is configured to receive the flexible probe 38. In some embodiments, the port 382 is funnel shaped.

[0094] 20-22, the transmission 402 of the steerable sheath 266 includes a drive gear 518 and a belt 522 coupled between the user input wheel 386 and the drive gear 518. In some embodiments, the belt 522 is a Kevlar belt. In the illustrated embodiment, the user input wheel 386 includes a gear 524 formed thereon and is coupled to the belt 522. In other words, the belt 522 rotatably couples the gear 524 to the drive gear 518. The transmission 402 further includes a first rack 526 that meshes with the drive gear 518 and a second rack 530 that meshes with the drive gear 518. A first pull wire 534 is coupled to the first rack 526 and a second pull wire 538 is coupled to the second rack 530. In some embodiments, the transmission includes only a single pull wire. In operation, the first rack 526 and the second rack 530 translate relative to the drive gear 518 in response to rotation of the drive gear 518 driven by the user input wheel 386. Translation of the first rack 526 and the second rack 530 relative to the housing 378 causes actuation of the first pull wire 534 and the second pull wire 538, which articulates the distal end 398 of the sheath 390. In some embodiments, actuation of the first pull wire 534 or the second pull wire 538 articulates the distal end 398 of the sheath 390. In some embodiments, the pull wires 534, 538 are attached to opposite sides of the distal end 398.

[0095] 24, the housing 378 includes a first slot 542 that at least partially receives the first rack 526 and a second slot 546 that at least partially receives the second rack 530. In the illustrated embodiment, the first rack 526 and the second rack 530 are slidable relative to the housing 378 along the axis 426. A detent 550 is positioned within the housing 378, the detent 550 engaging the transmission 402 when the user input wheel 386 is in the neutral position (FIG. 24). In the illustrated embodiment, the detent 550 is a ball spring detent that is at least partially received within a corresponding notch 554 formed in the first rack 526. As such, the detent 550 allows an operator to easily locate and the neutral position of the user input wheel 386.

[0096] 22 and 23, the steerable sheath 266 includes a brake assembly 558 that adjusts the amount of frictional engagement between the housing 378 and the user input wheel 386. In other words, the brake assembly 558 is configured to adjust the frictional resistance to rotating the user input wheel 386 about the axis 422. As detailed herein, the brake assembly 558 holds the position of the user input wheel 386 when the user input wheel 386 is released by the user. In other words, the friction provided by the brake assembly 558 causes the user input wheel 386 to remain in the rotated position left by the operator.

[0097] In the illustrated embodiment, the user input wheel 386 includes a hub 562 positioned around a boss 566 formed on the housing 378. In the illustrated embodiment, the hub 562 and boss 566 are aligned with the axis of rotation 422. The brake assembly 558 includes a sleeve 570 positioned around the boss 566 and a spring washer 574 positioned between the sleeve 570 and the hub 562. A fastener 578 secures the sleeve 570 to the boss 566, and the sleeve 570 is adjustably positioned relative to the hub 562 on the user input wheel 386. In the illustrated embodiment, the fastener 578 is a screw. Adjusting the fastener 578 to position the sleeve 570 closer to the hub 562 applies a greater compressive force to the spring washer 574, creating a greater frictional resistance to the rotation of the user input wheel 386. Similarly, adjusting fastener 578 to position sleeve 570 farther from hub 562 reduces the compressive force on spring washer 574 , reducing the frictional resistance to rotation of user input wheel 386 .

[0098] 25, a steerable sheath 582 is shown having a transmission 586 coupled between a user input wheel 590 and a distal end of the sheath 594. The transmission 586 includes a linkage 598 coupled to the user input wheel 590 with a pin 602 received in a corresponding helical slot 606. In the illustrated embodiment, the pin 602 moves within the helical slot 606 in response to rotation of the user input wheel 590. The linkage 598 translates linearly along an axis 610 in response to rotation of the user input wheel 590. In the illustrated embodiment, a rack 618 is coupled to the linkage 598, and the rack 618 meshes with a pinion 622. Rotation of the pinion 622 causes linear translation of a first rack 626 and a second rack 630. Similar to transmission 402 , pull wires 634 , 638 are coupled to racks 626 , 630 such that actuation of pull wires 634 , 638 articulates the distal end of sheath 594 .

[0099] 26, a steerable sheath 642 is shown having a transmission 646 coupled between a user input wheel 650 and a distal end of the sheath 654. The transmission 646 includes a planetary gear assembly 658, a first power screw 662, and a second power screw 666. A bevel gear 670 meshes with a gear ring 674 formed on the user input wheel 650. A shaft 678 extending from the bevel gear 670 extends into the planetary gear assembly 658 and transmits rotation from the user input wheel 650 to the planetary gear assembly 658. The power screws 662, 666 are coupled to the planetary gear assembly 658 and translate linearly in response to rotation of the user input wheel 650. In the illustrated embodiment, pull wires 682, 686 are coupled to the power screws 662, 666, such that actuation of the pull wires 682, 686 articulates the distal end of the sheath 654.

[0100] 27, a steerable sheath 690 is shown having a transmission 694 coupled between a user input wheel 698 and a distal end of the sheath. The transmission 694 includes a drive gear 702 that meshes with a gear ring 706 formed on the user input wheel 698 and a pawl 710 that selectively engages the gear ring 706 to lock the user input wheel 698 in place. In the illustrated embodiment, a pull wire 714 is coupled to the drive gear 702, and actuation of the pull wire 714 articulates the distal end of the sheath.

[0101] In some embodiments, the transmission of the steerable sheath includes at least one electrical component (e.g., a sensor, actuator, power source, controller, etc.) Advantageously, including an electrical component within the transmission can increase the precision with which the pull wires, and correspondingly, the distal end of the sheath, can be actuated.

[0102] 28, in some embodiments, the flexible probe 38 is manually inserted into the working channel 718 (i.e., into the steerable sheath or bronchoscope) and the operator manually feeds the flexible probe 38 into the working channel. However, conventional techniques can cause the flexible probe 38 to bend, buckle, kink, or otherwise damage the flexible probe 38 in response to manually feeding the flexible probe 38 into the working channel. For example, the patient's anatomy or the positioning of the scope or steerable sheath can make feeding the flexible probe 38 difficult. Specifically, there are strong forces associated with the probe tip exiting the end of the working channel and being forced into the tissue or lesion. These strong forces can result in undesirable buckling, bending, and / or kinking of the flexible probe 38, potentially damaging the flexible probe 38. As a result, conventional techniques require the user to "choke up" as much as possible on the probe and use very short forward strokes to reduce the unsupported length of the probe.

[0103] 29-30, an anti-buckling device 722 is shown to aid in the insertion of the flexible probe 38 into the working channel 718. The anti-buckling device 722 includes an entrance funnel 726, an outlet 730, and a number of support rails 734 extending between the entrance funnel 726 and the outlet 730. In the illustrated embodiment, there are two support rails. In some embodiments, the outlet 730 includes a threaded luer lock attachment. The flexible probe 38 is inserted through the entrance funnel 726 and exits the outlet 7360 into the working channel 718. In the illustrated embodiment, a portion of the flexible probe 38 is visible to an outside observer in the space between the support rails 734. In some embodiments, the anti-buckling device 722 is integrated into the working channel 718.

[0104] The anti-buckling device 722 further includes a collar 738 that is slidable relative to the support rail 734 and selectively coupled to the flexible probe 38. The collar 738 includes a button 742 that selectively engages the flexible probe 38 upon actuation of the button 742 by an operator. In the illustrated embodiment, the button 742 is biased by a biasing member toward a disengaged position in which the button 742 does not contact the flexible probe 38 and the collar 738 is movable relative to the flexible probe 38. A user depresses the button 742 to move the button 742 to an engaged position in which the button 742 abuts the flexible probe 38, locking the flexible probe 38 with the collar 738, such that movement of the collar 738 moves the flexible probe 38. In some embodiments, the button 742 may be lockable in the engaged position. Releasing the button 742 from the engaged position allows the button 742 to return to the disengaged position, thereby allowing the collar 738 to move relative to the probe 38. In some embodiments, the button or collar also engages the support rail 734 in addition to the probe, thus locking the position of the probe relative to the working channel.

[0105] The flexible probe 38 can also be moved relative to the anti-buckling device 722 by manually sliding the flexible probe 38. In other words, the user has the option of translating the flexible probe 38 using the collar 738 or their hand. In some embodiments, the anti-buckling device is hinged open with two parts that lock together so that the probe can be placed after it is already in the working channel (i.e., the anti-buckling device does not need to be in place prior to probe placement, and thus the probe does not need to be advanced through it first).

[0106] Various features and advantages are set forth in the following claims.

[0107] [Embodiment] (1) A steerable sheath, a handle including a housing, a port formed on the housing, and a user input wheel rotatably coupled to the housing; a sheath extending from the handle, the sheath including a proximal end coupled to the handle and a distal end; a transmission coupled between the user input wheel and the distal end of the sheath; A sheath, wherein actuation of the user input wheel articulates the distal end of the sheath. (2) A sheath as described in embodiment 1, wherein the distal end is curved at an angle when the user input wheel is in a neutral position. (3) The sheath of embodiment 2, further comprising a detent positioned within the housing, the detent engaging the transmission when the user input wheel is in the neutral position. (4) The sheath of embodiment 2, wherein the angle is 70°. (5) The sheath of embodiment 1, wherein the user input wheel includes a first indicator that is visible when the user input wheel is in the neutral position and a second indicator that is visible when the user input wheel is in a non-neutral position.

[0108] (6) The sheath of embodiment 1, further comprising a brake assembly for adjusting an amount of frictional engagement between the housing and the user input wheel. (7) the user input wheel includes a hub positioned about a boss formed on the housing, and the brake assembly includes: a sleeve positioned about the boss; a spring washer positioned between the sleeve and the hub; a fastener for securing the sleeve to the boss, the sleeve being adjustably positioned relative to the hub; 7. The sheath of embodiment 6, wherein the brake assembly maintains the position of the user-input wheel when the user-input wheel is released by the user. (8) The sheath of embodiment 1, wherein the port is connected to the sheath and an obturator is inserted through the port. (9) The sheath of embodiment 1, wherein the user input wheel rotates about an axis that intersects with a sheath axis and the longitudinal axis of the handle is aligned with the sheath axis. (10) The sheath of embodiment 1, wherein the handle includes a circumferential groove on an outer surface of the housing, the housing includes a tapered end, and the proximal end of the sheath is coupled to the tapered end.

[0109] (11) The transmission, A drive gear and a belt coupled between the user input wheel and the drive gear; A first rack that meshes with the drive gear; A second rack that meshes with the drive gear; a first pull wire coupled to the first rack; 2. The sheath of embodiment 1, wherein actuation of the first pull wire articulates the distal end of the sheath. (12) The sheath of embodiment 11, wherein the transmission further includes a second pull wire coupled to the second rack, and actuation of the second pull wire articulates the distal end of the sheath. (13) The sheath of embodiment 11, wherein the first rack and the second rack translate relative to the drive gear in response to rotation of the user input wheel, and the housing includes a first slot that at least partially receives the first rack and a second slot that at least partially receives the second rack such that the first rack and the second rack are slidable relative to the housing. (14) The sheath of embodiment 1, wherein the user input wheel has a first exposed portion and a second exposed portion and is positioned within the handle, and the housing is positioned between the first exposed portion and the second exposed portion. (15) The sheath of embodiment 1, wherein the user input wheel is rotatably coupled to the housing about an axis aligned with a longitudinal axis of the housing, and the user input wheel is an actuation ring.

[0110] (16) The sheath of embodiment 1, wherein the user input wheel is spaced from the proximal end of the housing. (17) The sheath of embodiment 1, wherein the transmission includes a linkage coupled to the user input wheel by a pin and a helical slot, the linkage translating linearly in response to rotation of the user input wheel. (18) The sheath of embodiment 1, wherein the transmission includes a planetary gear assembly and a power screw. (19) The sheath of embodiment 1, wherein the transmission includes a ratchet. (20) The sheath of embodiment 1, wherein the transmission includes at least one electrical component, the electrical component being a sensor, an actuator, a power source, or a controller.

Claims

1. A steerable sheath, a handle including a housing, a port formed on the housing, and a user input wheel rotatably coupled to the housing; a sheath extending from the handle, the sheath including a proximal end coupled to the handle and a distal end; a transmission coupled between the user input wheel and the distal end of the sheath; A sheath, wherein actuation of the user input wheel articulates the distal end of the sheath.

2. The sheath of claim 1 , wherein the distal end is curved at an angle with the user-input wheel in a neutral position.

3. The sheath of claim 2 , further comprising a detent positioned within the housing, the detent engaging the transmission with the user input wheel in the neutral position.

4. The sheath of claim 2 , wherein the angle is 70°.

5. 10. The sheath of claim 1, wherein the user input wheel includes a first indicator that is visible when the user input wheel is in the neutral position and a second indicator that is visible when the user input wheel is in a non-neutral position.

6. The sheath of claim 1 , further comprising a brake assembly that adjusts an amount of frictional engagement between the housing and the user input wheel.

7. the user input wheel includes a hub positioned about a boss formed on the housing, and the brake assembly includes: a sleeve positioned about the boss; a spring washer positioned between the sleeve and the hub; a fastener for securing the sleeve to the boss, the sleeve being adjustably positioned relative to the hub; The sheath of claim 6 , wherein the brake assembly maintains a position of the user-input wheel when the user-input wheel is released by a user.

8. The sheath of claim 1 , wherein the port is connected to the sheath and an obturator is inserted through the port.

9. The sheath of claim 1 , wherein the user input wheel rotates about an axis that intersects a sheath axis, and wherein a longitudinal axis of the handle is aligned with the sheath axis.

10. The sheath of claim 1 , wherein the handle includes a circumferential groove on an outer surface of the housing, the housing includes a tapered end, and the proximal end of the sheath is coupled to the tapered end.

11. The transmission, A drive gear and a belt coupled between the user input wheel and the drive gear; A first rack that meshes with the drive gear; A second rack that meshes with the drive gear; a first pull wire coupled to the first rack; The sheath of claim 1 , wherein actuation of the first pull wire articulates the distal end of the sheath.

12. The sheath of claim 11 , wherein the transmission further includes a second pull wire coupled to the second rack, actuation of the second pull wire articulating the distal end of the sheath.

13. 12. The sheath of claim 11, wherein the first rack and the second rack translate relative to the drive gear in response to rotation of the user input wheel, and the housing includes a first slot that at least partially receives the first rack and a second slot that at least partially receives the second rack such that the first rack and the second rack are slidable relative to the housing.

14. 2. The sheath of claim 1, wherein the user input wheel is positioned within the handle with a first exposed portion and a second exposed portion, and the housing is positioned between the first exposed portion and the second exposed portion.

15. The sheath of claim 1 , wherein the user input wheel is rotatably coupled to the housing about an axis aligned with a longitudinal axis of the housing, the user input wheel being an actuation ring.

16. The sheath of claim 1 , wherein the user input wheel is spaced from a proximal end of the housing.

17. The sheath of claim 1 , wherein the transmission includes a linkage coupled to the user input wheel by a pin and a helical slot, the linkage translating linearly in response to rotation of the user input wheel.

18. The sheath of claim 1 , wherein the transmission includes a planetary gear assembly and a power screw.

19. The sheath of claim 1 , wherein the transmission includes a pawl.

20. The sheath of claim 1 , wherein the transmission includes at least one electrical component, the electrical component being a sensor, an actuator, a power source, or a controller.

Images