Malleable suction device with an offset position sensor

Abstract

A device, such as a suction instrument, includes a position sensor proximate the distal tip of a malleable shaft. A sensor wire couples the position sensor to a processor of an image-guided surgery system so that signals generated by the position sensor can be interpreted to determine the position of the surgical instrument. The malleable shaft includes a malleable outer shaft and a flexible inner tube. The flexible inner tube includes a main lumen that can provide suction, fluid, or various deployable surgical tools, and an inner lumen that holds the sensor wire. The sensor wire, protected within the inner lumen, extends the length of the shaft, exits the inner lumen, and passes through a slot in the outer shaft to reach the position sensor. A heat shrink cover encases the distal tip, sealing the components together and providing an opening suitable for suction.

Description

Technical Field

[0001] (Priority) This application claims priority to U.S. Provisional Patent Application No. 63 / 023,486, filed May 12, 2020, entitled "Malleable Suction Instrument with Offset Position Sensor", the disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Image-guided surgery (IGS) is a technique that uses a computer to obtain a real-time correlation of the location of an instrument inserted into a patient's body with a set of preoperatively obtained images (e.g., CT scan or MRI scan, 3D map, etc.), so that the computer system can superimpose the current location of the instrument on the preoperatively obtained images. An example of an electromagnetic IGS navigation system that can be used in IGS procedures is the CARTO® 3 System by Biosense-Webster, Inc. (Irvine, California). In some IGS procedures, a digital tomographic scan of the surgical field (e.g., CT or MRI, 3D map, etc.) is obtained prior to surgery. Next, a specially programmed computer is used to convert the digital tomographic scan data into a digital map. During surgery, a special instrument with a sensor (e.g., an electromagnetic coil that generates and / or responds to an externally generated electromagnetic field) is used to perform the procedure, and at the same time, the sensor sends data indicating the current position of each surgical instrument to the computer. The computer correlates the data received from the sensor with the digital map created from the preoperative tomographic scan. The tomographic scan images are displayed on a video monitor with an indication (e.g., a crosshair or a bright dot, etc.) showing the real-time position of each surgical instrument relative to the anatomical structures shown in the scan image. Thus, even when the surgeon cannot directly visualize the instrument itself at its current location within the body, the surgeon can know the exact position of each sensor-equipped instrument by looking at the video monitor.

[0003] Position sensors that enable detection and display of the position of an instrument during IGS navigation are commonly located at or near the distal tip of the surgical instrument being tracked. Sensor wires couple the position sensors to a controller or processor, which receives signals indicative of the position of the instrument, interprets those signals, and provides and displays them on an IGS navigation interface. Since the sensor wires extend along the entire length of the instrument and have a relatively small diameter, they are vulnerable to damage and signal loss as a result of normal activities (e.g., advancement, rotation, or deflection of the shaft of a surgical instrument, deployment of a tool through a catheter or channel, operation of a drilling or cutting feature of a surgical instrument).

[0004] In surgical procedures, several systems and methods have been created and used, but the inventors believe that no one has previously made or used the invention described in the appended claims.

Brief Description of the Drawings

[0005] This specification concludes with claims that particularly show and distinctly claim the invention, but the invention is believed to be more fully understood by reading the following detailed description of specific embodiments in conjunction with the accompanying drawings. In the figures, like reference numerals indicate like elements.

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[0006] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the present invention can be implemented in various other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some aspects of the present invention and together with the description serve to explain the principles of the present invention. However, it is understood that the present invention is not limited to the exact arrangements shown.

Best Mode for Carrying Out the Invention

[0007] The following description of specific embodiments of the present invention should not be used to limit the scope of the present invention. Other embodiments, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which is one of the best modes contemplated for practicing the present invention by way of example. As will be understood, the present invention is capable of other different and distinct aspects without departing from the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0008] The terms "proximal" and "distal" are to be understood as being used herein with respect to a clinician holding the handpiece assembly. That is, the end effector is distal to the more proximal handpiece assembly. For convenience and clarity, spatial terms such as "upper" and "lower" are also to be further understood as being used herein with reference to a clinician holding the handpiece assembly. However, the surgical instrument is used in many orientations and positions, and these terms are not intended to be limiting and absolute.

[0009] It is further understood that any one or more of the teachings, expressions, variations, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, variations, examples, etc. described herein. Accordingly, the teachings, expressions, variations, examples, etc. described below should not be considered in isolation from one another. Various suitable ways of combining the teachings of this specification will be readily apparent to those skilled in the art in view of the teachings of this specification. Such modifications and variations are intended to be included within the scope of the claims.

[0010] I. Exemplary Image-Guided Surgery Navigation System When performing a medical procedure within the head (H) of a patient (P), especially when the instrument is in a location where it is difficult or impossible to obtain an endoscopic view of the working element of the instrument within the head (H) of the patient (P), it may be desirable to have information regarding the position of the instrument within the head (H) of the patient (P). FIG. 1 shows an exemplary IGS navigation system (10) that enables the performance of ENT procedures using image guidance. In addition to, or instead of, having the components and operability described herein, the IGS navigation system (10) may be configured and operable in accordance with at least a portion of the teachings of U.S. Patent No. 7,720,521, entitled "Methods and Devices for Performing Procedures within the Ear, Nose, Throat and Paranasal Sinuses" (issued May 18, 2010) (the disclosure of which is incorporated herein by reference in its entirety), and U.S. Patent Application Publication No. 2014 / 0364725, entitled "Systems and Methods for Performing Image Guided Procedures within the Ear, Nose, Throat and Paranasal Sinuses" (published December 11, 2014) (the disclosure of which is incorporated herein by reference in its entirety).

[0011] The IGS navigation system (10) of this embodiment includes a magnetic field generator assembly (20), and the magnetic field generator assembly (20) includes a set of magnetic field generators (24) incorporated in a horseshoe-shaped frame (22). The magnetic field generators (24) are operable to generate alternating magnetic fields of different frequencies around the head (H) of the patient (P) to generate a tracked area with which the IGS navigation system (10) associates a coordinate system. In this embodiment, a navigation guide wire (40) is inserted into the head (H) of the patient (P). The navigation guide wire (40) may be a stand-alone device or may be positioned at the end effector or other location of a medical instrument such as a surgical cutting instrument or an expansion instrument. In this embodiment, the frame (22) is attached to the chair (30), and the patient (P) sits on the chair (30) such that the frame (22) is positioned adjacent to the head (H) of the patient (P). By way of example only, the chair (30) and / or the magnetic field generator assembly (20) may be configured and operable in accordance with at least a portion of the teachings of U.S. Patent No. 10,561,370, titled "Apparatus to Secure Field Generating Device to Chair" (issued February 18, 2020), the disclosure of which is incorporated herein by reference in its entirety.

[0012] The IGS navigation system (10) of this embodiment further includes a processor (12), and the processor (12) controls the magnetic field generator (24) and other elements of the IGS navigation system (10). For example, the processor (12) drives the magnetic field generator (24) to generate an alternating electromagnetic field, and processes signals from the navigation guide wire (40) to determine the location of sensors within the navigation guide wire (40) within the patient's (P) head (H). The processor (12) is a processing unit that communicates with one or more memories (for example, a set of electronic circuits configured to evaluate and execute software instructions using combinational logic circuits or other similar circuits). The processor (12) of this embodiment is mounted within a console (18) that includes an operation control unit (14) including a keypad and / or a pointing device such as a mouse or trackball. The physician interacts with the processor (12) using the operation control unit (14) while performing a surgical procedure.

[0013] The navigation guide wire (40) includes a sensor (not shown) that responds to its positioning within the alternating magnetic field generated by the magnetic field generator (24) and generates data that can be used to determine the position of the sensor within the magnetic field. A coupling unit (42) is fixed to the proximal end of the navigation guide wire (40) and is configured to provide communication of data and other signals between the console (18) and the navigation guide wire (40). The coupling unit (42) can provide wired or wireless communication of data and other signals. In this example, the position sensor is located within the guide wire (40), but such position sensors may be integrated into various other types of instruments such as extended catheters, guide catheters, guide rails, aspiration instruments, pointer instruments, alignment probes, curettes, patient tracking devices, and other instruments, which will be described in more detail below.

[0014] The processor (12) uses software stored in the memory of the processor (12) to calibrate and operate the IGS navigation system (10). Such operations include driving the magnetic field generator (24), processing data from the navigation guide wire (40), processing data from the motion control unit (14), and driving the display screen (16). The processor (12) is further operable to provide a real-time video via the display screen (16) indicating the position of the distal end of the navigation guide wire (40) with respect to a video camera image of the patient's head (H), a CT scan image of the patient's head (H), and / or a computer-generated three-dimensional model of the anatomical structures within and adjacent to the patient's nasal cavity. The display screen (16) can display such images simultaneously and / or superimposed on one another during the surgical procedure. Such display images can also include a graphical representation of an instrument inserted into the patient's head (H), such as the navigation guide wire (40), so that the operator can view a virtual rendering of the instrument in its actual location in real time. By way of example only, the display screen (16) can provide images in accordance with at least a portion of the teachings of U.S. Patent No. 10,463,242, entitled "Guidewire Navigation for Sinuplasty" (issued November 5, 2019) (the disclosure of which is incorporated herein by reference in its entirety). If the operator is also using an endoscope, the endoscope image can also be provided on the display screen (16).

[0015] II. Exemplary Suction Instrument Having a Laterally Offset Position Sensor The surgical instrument tracked by the IGS navigation system (10) can include a position sensor that reacts to an alternating magnetic field generated by a magnetic field generator assembly (20), thereby generating a signal indicating the position of the sensor within the magnetic field. Such a position sensor can communicate with a connected device, such as a coupling unit (42) or a processor (12), via one or more sensor wires extending from the sensor itself along the length of the surgical instrument. In some aspiration instruments or delivery catheters, the sensor wires can be positioned within the main channel of the instrument or outside the shaft and can be coupled to the position sensor at the distal end of the instrument. In such an implementation, there can be a risk of damage to the external sensor wires by another instrument (e.g., a drilling or cutting instrument used in conjunction), or a risk of damage to the internal sensor wires by an instrument passing through the channel (e.g., a stylet used to remove an obstruction within an aspiration instrument, a cutting instrument passing through a delivery catheter).

[0016] To protect delicate sensor wires during use and prevent loss of instrument tracking due to damaged wires, a surgical instrument may implement a dedicated channel that protects the sensor wire while not impairing the normal operation of the instrument. As an example, FIG. 2 shows a perspective view of an exemplary aspiration instrument (100) with the path of an embedded position sensor wire shown in dotted lines. The aspiration instrument (100) includes a grip (102) adapted to be held by hand during use in a medical procedure, a shaft assembly (104) whose distal end can be inserted into a patient during use, and a tip (106) at the distal end of the shaft assembly (104) where aspiration and / or irrigation can be provided when positioned near the surgical site. A hose connector (112) can be coupled to an aspiration and / or irrigation source via a hose or tube. The hose connector (112) extends through the shaft assembly (104) and provides access to an aspiration channel that terminates at the distal tip (106). A port (114) is positioned in the grip (102) and opens into the aspiration channel. When the port (114) is uncovered, aspiration from the hose connector (112) aspirates mainly to the atmosphere at the port (114) instead of at the distal tip (106). When the port (114) is covered, aspiration is communicated to the distal tip (106). Thus, the user can selectively apply aspiration at the surgical site by covering or uncovering the port (114) (e.g., with a thumb or other finger when holding the grip (102)).

[0017] The cable (110) holds and protects the portion of the sensor wire that is located outside the aspiration device (100). The sensor wire (130) can be much smaller in diameter than the cable (110) and can include a flexible rubber coating. After exiting the cable (110), the sensor wire (130) extends along a path within the aspiration device (100) illustrated by the dashed line in FIG. 1. When the aspiration device (100) is in use, it may be necessary to extend a stylet or other debris removal tool through the aspiration channel via the hose connector (112), port (114), or distal tip (106). The shaft assembly (104) can also be shaped or flexed in different ways to position the distal tip (106) at the surgical site across an anatomical passage. In either case, it can be seen that without protection, a significant length of the sensor wire (130) can be damaged during debris removal or shaping.

[0018] FIG. 3 shows an exploded perspective view of the aspiration device (100). The grip (102) is separated into a first half (102a) and a second half (102b), which are adapted to hold the body (116) and whose hollow interior defines an aspiration channel. It can be seen that the components of the shaft assembly (104) include a shaft base (120), an outer shaft (122), and an inner tube (124). The inner tube (124) is of a diameter that allows the inner tube (124) to fit snugly inside the outer shaft (122) and is of a length similar to that of the outer shaft (122). The outer shaft (122) is of a diameter that allows the outer shaft (122) to fit snugly inside the shaft base (120), and the shaft base (120) itself is of a diameter that fits snugly within the distal aspiration channel opening (121) of the body (116).

[0019] It can be seen that the sensor wire (130) projects from the aspiration channel opening (121) and terminates at a position sensor (132) proximate to the distal end of the outer shaft (122). The position sensor (132), like the position sensors within the guide wire (40) described above, is configured to generate a signal indicative of the location of the position sensor (132) within three-dimensional space (e.g., within the head (H) of a patient (P)) in response to an alternating electromagnetic field generated by a magnetic field generator (24), and may include one or more coils. As will be illustrated in more detail below, when the aspiration device (100) is fully assembled, the sensor wire (130) is immediately received within the inner lumen (125) of the inner tube (124) (shown in FIGS. 4, 5A, 5C-7, and 10-11). The inner lumen (125) may be formed inside the inner tube (124) as part of a manufacturing process (e.g., an extrusion process), or may be a separate component that is later coupled inside the inner tube (124).

[0020] As will be illustrated in more detail below, the position sensor (132) is sized to fit within the sensor cover (126), which itself is sized to fit within a slot at the distal end of the outer shaft (122). The shaft base (120) can be formed of stainless steel (e.g., or another metal), and can be malleable or rigid, depending on the length of the shaft assembly (104), which desirably is formable. The shaft base (120) stiffens the proximal side of the shaft assembly (104) relative to the distal end to provide for tool maneuverability during a surgical procedure. The outer shaft (122) can be formed of a malleable material such as stainless steel, while the inner tube (124) can be formed of a polymer or other flexible material so as to be shaped by the outer shaft (122). The cover (126) can be formed of a rigid polymer, metal, or other material. The cover (126) can protect the sensor (132) from damage by parallel use with a navigation or other surgical tool (e.g., drill, debris aspirator), while the material of the outer shaft (122) (e.g., stainless steel) protects the sensor wire (130) from the same damage. Merely by way of example, the inner tube (124) can have a wall thickness of about 0.005 inches and can be composed of a flexible material (e.g., Pebax 5333, Tecobax MPD-441-45D) that accommodates bending of the outer shaft (122) with a bend radius of 0.25 inches or more without twist or other damage to the sensor wire (130).

[0021] FIG. 4 shows a cross-sectional view of the body (116) of the suction device (100). The proximal ends of the shaft base (120), the outer shaft (122), and the inner tube (124) appear to be coaxially nested within each other and within the distal end (116) of the body. A portion of the sensor wire (130) can be seen extending along the lower side of the body (116) and outside the suction channel (109). The sensor wire (130) enters the suction channel (109) through a laterally facing hole (111) formed in the side wall of the body (116) and immediately enters an inner lumen (125) that extends along the inner wall of the inner tube (124). The hole (111) and the inner lumen (125) are positioned to minimize or completely eliminate any length of the sensor wire (130) that is exposed within the suction channel (109) in order to reduce the risk associated with the use of a stylet or other tool to remove obstructions from the suction channel (109). In some implementations, the sensor wire (130) can be loosely positioned within the suction device (100) between the body (116) and the grip (102) and has a full length that allows some movement of the sensor wire (130) due to bending or shaping of the outer shaft (122). This can allow the sensor wire to shift longitudinally within the inner lumen (125) or be pinched without breaking as a result of the shaping.

[0022] FIG. 5A shows an exploded perspective view of the distal tip (106) of the aspiration device (100). It can be seen that the sensor wire (130) exits the distal end of the inner lumen (125) and is coupled to the sensor (132). The sensor cover (126) has a ball-shaped distal end to form a ball tip or ball point aspiration device (100), although other shapes may be used as well. The sensor cover (126) includes an opening sized to receive the sensor (132), which can be loosely fitted, frictionally fitted, or fixed within the cover (126) by an adhesive or other coupling element or material. The cover (126) is sized to fit within the lateral slot (144) at the distal end of the outer shaft (122), as can be seen in the fully assembled distal tip (106) of FIG. 5B. In this figure, it can be seen that the sensor (132) is housed within the sensor cover (126) and a small portion of the sensor wire (130) extends from the sensor cover (126) and enters the inner lumen (125). The sensor cover (126) is positioned within the slot (144) directly above the distal opening (136) of the outer shaft (122) such that the opening (136) is unobstructed and can deliver focused aspiration and / or irrigation, and substantially or completely fills the distal end of the slot (144). The sensor cover (126) has a bevel (127) at its proximal end, which provides a substantially smooth transition outside of the shaft assembly (104) and can also protect the inside of a portion of the sensor wire (130) passing through the slot (144), as best seen in FIG. 5C.

[0023] As shown in FIG. 5C, the cover seal (134) wraps around the distal tip (106) and, in some implementations, may extend along a portion or all of the remainder of the shaft assembly (104). The cover seal (134) can be, for example, a polymeric heat trap coating, which is loosely disposed on the distal tip (106) and then heated to shrink and fit snugly to create a seal, or it can be a sealant or coating, which is applied and dried or cured to hold the components of the distal tip (106) in place and seal gaps. The cover seal (134) substantially covers the sensor cover (126), extends down along its bevel (127) to the outer shaft (122), where it covers the entire slot (144) to concentrate suction at the distal opening (136) and prevent loss of suction through the slot (144).

[0024] FIG. 5C shows a cross-sectional view of the assembled distal tip (106) of FIG. 5B. The cover seal (134) can be seen at the outer edge of the assembly and holds the sensor cover (126) within the slot (144). The edges of the slot (144) receive and hold the sensor cover (126) such that the application of the cover seal (134) joins the components together and prevents shifting, while being sized to prevent the sensor cover (126) from passing completely through the slot (144). The cover seal (134) extends under the bevel (127) of the sensor cover (126) to cover all of the shaft (144), creating a small gap between the distal opening of the inner lumen (125) and the opening of the sensor cover (126) through which the control wire (130) is loosely draped, allowing for movement or flexure of the sensor wire (130) as a result of bending of the shaft assembly (104). The inner lumen (125) can be sealed at one or both openings or can remain open. In some implementations, the sensor wire (130) can substantially fill the interior of the inner lumen (125) such that any aspiration or irrigation effects on the inner lumen (125) are minimal. The sensor cover (126) and the inner lumen (125) can be sized and shaped to minimize or eliminate any portion of the control wire (130) that is exposed to the aspiration channel (109) as shown in FIG. 5C. As can be seen from the figure, a stylet or other channel deobstruction tool passing through the aspiration channel (109) in either direction is deflected from contact with the sensor wire (130) by the edge or underside of the inner lumen (130) or the underside of the sensor cover (126).

[0025] FIG. 6 shows a perspective view of the inner tube (124) with the sensor wire (130) extending from the inner lumen (125) and connected to the position sensor (132). By removing the outer shaft (122) and the sensor cover (126), the inner lumen (125) that holds the sensor wire (130) and the main lumen (142) that defines the suction channel (109) at the distal tip (106) can be seen. FIG. 7 shows an elevation view looking down on the inner tube (124). It can be seen that the inner lumen (125) is coupled or formed on the inner wall of the main lumen (142), and most of the interior of the inner tube (124) is not blocked, allowing for sufficient suction flow.

[0026] The inner tube (124) shown in FIG. 7 and elsewhere is shown with the inner lumen (125) continuously positioned on the upper inner wall of the inner tube (124), but some implementations may include an inner lumen positioned elsewhere (e.g., on a side wall or bottom wall), or an inner lumen that extends non-linearly along the inner wall of the inner tube (124) such that it twists along the inside of the shaft. As an example, the origin position (123) of the inner lumen (125) is illustrated in FIG. 7. In implementations where the proximal opening of the inner lumen is positioned as illustrated in FIG. 7, the length of the control wire that is exposed to the suction channel (109) after entering the body (116) is further minimized (e.g., referring to FIG. 4, the length of the control wire (130) between the hole (111) and the opening of the inner lumen (125) is further minimized). The rate at which the position of the inner lumen (125) twists can be selected such that it is positioned adjacent to the opening in the side wall of the body and then twists stepwise along the shaft until it is directly below the slot (144) at the distal tip (106).

[0027] Figure 8 shows a perspective view of the outer shaft (122) and the slot (144). With the sensor cover (126) removed, it can be seen that the slot (144) extends from the distal opening (136) down a portion of the length of the outer shaft (122) such that the slot (144) enables the sensor cover (126) to be received and such that the sensor wire (130) can exit the inner lumen (125), pass through the slot (144), and enter the sensor cover (126). Figure 9 shows an elevation view looking down on the outer shaft (122). As has been described, the slot width (144) can be such that the entire diameter of the sensor cover (126) cannot pass completely through the slot (144). In other words, the outer diameter of the sensor cover (126) is greater than the width of the slot (144).

[0028] Figure 10 shows an elevation view looking down on the assembled inner tube (124) and outer shaft (122) with the inner lumen (125) aligned with the slot (144) and the main lumen (142) fed into the distal opening (136) of the outer shaft (122). Figure 11 shows the assembled distal tip (106) with the sensor cover (126) installed within the slot (144) and aligned with the inner lumen (125). As shown in Figures 5B and 5C, with the seal cover (134) installed, the suction channel within the shaft assembly (104) is unbroken, and thus the resulting suction is focused at the distal opening (136). Further, with the sensor cover (126) blocking the slot (144), it can be seen that the distal opening (136) itself is unbroken and enables strong suction when the distal opening (136) contacts material or fluid. It should also be understood that the sensor cover (126) does not substantially block the main lumen (142) or the distal opening (136) (e.g., blocks only about 10% or less of the circular area of the distal opening (136), although different implementations can block from about 5% to about 25% of the opening).

[0029] As also shown in FIGS. 2, 5B - 5C, and 11, the position sensor (132) is oriented along an axis that is parallel to the central longitudinal axis of the shafts (122, 124), but is slightly axially offset therefrom. The distance of this lateral offset can be pre - determined and fixed. Thus, the processor (12) can immediately calculate the exact location of the distal opening (136) in three - dimensional space based on the position indication signal generated by the position sensor (132). Another advantage of the sensor cover (126) being at the distal end of the aspiration device (100) is that it provides a visually recognizable reference point for the user of the aspiration device (100). As an example, it can be seen that the sensor cover (126) has a convex shape that extends as a ball point from the slot (144). This ball - point shape provides a visually recognizable reference point indicating the location and orientation of the aspiration device (100) when viewed directly, or through an endoscope or other camera, or through an IGS display with a crosshair, illuminated dot, or some other visual indicator overlaid on the ball point.

[0030] The above considerations have referred to the aspiration device (100) and aspiration devices in general as being advantageously implemented with a protected sensor wire, but it should be understood that the structures and features disclosed herein can be advantageously implemented in various surgical or other medical devices including shafts and distally mounted position sensors. As an example, catheters (e.g., fixed, multi - jointed, or malleable catheters) used to guide other instruments to the surgical site, shaver instruments, dilation catheters, and various other types of instruments that will be apparent to those skilled in the art in view of the teachings herein, such instruments can implement a flexible inner lumen that protects the sensor wire without blocking the delivery channel.

[0031] Variations of the above-described systems, methods, and interfaces will exist and will be apparent to those skilled in the art in view of the present disclosure. For example, some of the above discussions describe the first point as the position of the virtual camera, but it should be understood that in some implementations, the first point may be the orientation of the virtual camera. This can be advantageous when a clinician uses real-time virtual endoscopy preview and relational fly-through to determine a position within the surgical area of interest before making a selection, selects that position as the point of orientation (i.e., the second point), and then desires to preview a number of camera positions (e.g., the first point). Selecting the position of the virtual camera as the first point can be advantageous when a clinician can use their experience to first determine the best position of the virtual camera and then, using real-time virtual endoscopy preview and relational fly-through, can select the point in the surgical area where they want to focus the virtual camera.

[0032] III. Exemplary Combinations The following examples relate to various non-exhaustive ways in which the teachings of this specification can be combined or applied. It should be understood that the following examples are not intended to limit the claims that may be presented at any point in this application or in a subsequent application of this application. No waiver of any rights is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings of this specification can be configured and applied in many other ways. Also, in some variations, it is contemplated that specific features mentioned in the following examples may be omitted. Accordingly, none of the aspects or features mentioned below should be considered important unless so explicitly indicated later by the inventors or their successors in title. If the claims presented in this application or in a subsequent application related to this application include additional features other than those mentioned below, those additional features should not be considered to have been added for any reason related to patentability.

Example

[0033] An apparatus comprising: (a) a body; (b) a shaft assembly extending distally from the body, the shaft assembly comprising: (i) an outer shaft including a distal opening and a slot in the distal opening; (ii) an inner tube positioned within the outer shaft, the distal opening of the inner tube being longitudinally offset from the distal opening of the outer shaft and aligned with the slot; and (iii) an inner lumen positioned on the inner wall of the inner tube; (c) a position sensor; (d) a sensor cover housing the position sensor and positioned within the slot proximate to the distal opening of the inner lumen; and (e) a sensor wire configured to transmit a signal from the position sensor, the sensor wire being positioned within the inner lumen, exiting the inner lumen through the distal opening of the inner lumen, entering the sensor cover, and coupling to the position sensor.

Example

[0034] The apparatus according to Example 1, further comprising a shaft cover surrounding the sensor cover and the outer shaft, sealing any gap where the sensor cover contacts the outer shaft, and sealing any open portion of the slot.

Example

[0035] The apparatus according to Example 2, including a heat trap cover, wherein the shaft cover fits loosely over the sensor cover and the outer shaft and is then adapted to be tightly sealed by heat treatment.

Example

[0036] The apparatus according to Example 3, further comprising: (a) a grip housing the body and at least a portion of the sensor wire located outside the body; and (b) a suction connector located at the proximal end of the body and adapted to be coupled to a suction source.

Example

[0037] The device according to any one or more of Examples 1 to 4, wherein the sensor cover closes (i) most of the distal opening of the inner lumen and (ii) less than about 15% of the circular area of the distal opening of the outer shaft.

Example

[0038] The device according to any one or more of Examples 1 to 5, wherein the sensor wire is configured to translate within the inner lumen while remaining coupled to the position sensor.

Example

[0039] The device according to any one or more of Examples 1 to 6, wherein the inner lumen is twisted along the inside of the inner tube such that (i) the proximal opening of the inner lumen is positioned on the inner sidewall of the inner tube and (ii) the distal opening of the inner lumen is positioned on the inner top of the inner tube.

Example

[0040] The device according to any one or more of Examples 1 to 7, wherein the outer shaft is made of a malleable material and the inner tube is made of a flexible material.

Example

[0041] The device according to Example 8, wherein (i) the malleable material of the outer shaft includes stainless steel and (ii) the flexible material of the inner tube includes a polymer.

Example

[0042] The device according to Example 9, wherein the polymer is adapted to allow a bending radius of the inner tube of at least 0.25 inches without twisting or breaking.

Example

[0043] The sensor cover has a diameter, the slot has a width, and the diameter of the sensor cover is greater than the slot width such that the sensor cover occupies the entire width of the slot, the device according to any one or more of Examples 1 to 10.

Example

[0044] The longitudinal axis of the sensor cover is offset from the longitudinal axis of the inner lumen, and a portion of the sensor wire is bent at an angle to enable the sensor wire to span between the inner lumen and the sensor cover offset therefrom, the device according to any one or more of Examples 1 to 11.

Example

[0045] The diameter of the sensor wire substantially occupies the diameter of the inner lumen, the device according to any one or more of Examples 1 to 12.

Example

[0046] The position sensor includes at least one coil configured to generate position data based on interaction with an alternating magnetic field and transmit the position data via the sensor wire, the device according to any one or more of Examples 1 to 13.

Example

[0047] The opening of the sensor cover is angled such that the proximal edge of the sensor cover extends upward from the outer shaft at an angle of less than 90 degrees, the device according to any one or more of Examples 1 to 14.

Example

[0048] The body includes a longitudinal channel terminating at a distal channel opening, and the shaft assembly is positioned at the distal channel opening and coupled to the body, the device according to any one or more of Examples 1 to 15.

Example

[0049] The device according to any one or more of Examples 1 to 16, wherein the sensor wire enters a hole in the body proximate to the proximal opening of the inner lumen and then enters the inner lumen through the proximal opening of the inner lumen.

Example

[0050] (a) A shaft assembly including: (i) an outer shaft having a distal opening and a slot at the distal opening; (ii) an inner tube positioned within the outer shaft, with the distal opening of the inner tube longitudinally offset from the distal opening of the outer shaft and aligned with the slot; and (iii) an inner lumen positioned on the inner wall of the inner tube; (b) a position sensor; and (c) a sensor wire configured to transmit a signal from the position sensor, the sensor wire being (i) housed within the inner lumen and isolated from the interior of the inner tube, and (ii) exiting the inner lumen through the distal opening of the inner lumen, passing through the slot, and coupling to the position sensor.

Example

[0051] The device according to Example 18, further comprising a sensor cover that holds the position sensor and is positioned within the slot proximate to the distal opening of the inner lumen.

Example

[0052] The device according to Example 19, further comprising a shaft cover that surrounds the sensor cover and the outer shaft, seals any gap where the sensor cover contacts the outer shaft, and seals any open portion of the slot.

Example

[0053] The device according to any one or more of Examples 18 to 20, wherein the sensor cover (i) closes most of the distal opening of the inner lumen and (ii) closes less than about 15% of the circular area of the distal opening of the outer shaft.

Example

[0054] An apparatus according to any one or more of Examples 18 to 21, wherein the inner lumen is twisted along the inside of the inner tube such that (i) the proximal opening of the inner lumen is positioned on the inner sidewall of the inner tube and (ii) the distal opening of the inner lumen is positioned on the inner top of the inner tube.

Example

[0055] A method for assembling a suction device, comprising: (a) coupling a shaft assembly to a body, the shaft assembly comprising: (i) an outer shaft comprising a distal opening and a lateral slot extending proximally from the distal opening; (ii) an inner tube positioned within the outer shaft, the distal opening of the inner tube being longitudinally offset from the distal opening of the outer shaft; and (iii) an inner lumen positioned on the inner wall of the inner tube; (b) inserting a position sensor into a sensor cover; (c) inserting the sensor cover into the slot in proximity to the distal opening of the inner lumen; and (d) routing a sensor wire through the inner lumen, the sensor wire being coupled to the position sensor and configured to transmit a signal from the position sensor.

Example

[0056] The method according to Example 23, further comprising installing a shaft cover that seals any gap where the sensor cover contacts the outer shaft and seals any open portion of the slot.

[0057] IV. Others It should be understood that any of the examples described herein may include various other features in addition to or instead of those described above. By way of example only, any of the examples described herein can include one or more of the various features disclosed in any of the various references incorporated herein by reference.

[0058] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described in this specification can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described in this specification. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from each other. Various suitable ways of combining the teachings of this specification will be readily apparent to those skilled in the art in view of the teachings of this specification. Such modifications and variations are intended to be included within the scope of the claims.

[0059] It should be understood that all or part of any patent, publication, or other disclosure referred to as being incorporated by reference herein is incorporated herein only to the extent that the incorporated content does not conflict with the existing definitions, opinions, or other disclosure described in this disclosure. By itself, and to the extent necessary, the disclosure clearly described herein shall supersede any conflicting description incorporated herein by reference. Any content, or portion thereof, that is referred to as being incorporated by reference herein but conflicts with the current definitions, opinions, or other disclosure described in this specification shall be incorporated only to the extent that no conflict arises between the incorporated content and the current disclosure.

[0060] The deformable forms of the devices disclosed herein can be designed to be disposed of after a single use or to be used multiple times. The deformable forms can, in either or both cases, be readjusted for reuse after at least one use. Readjustment can include any combination of a device disassembly process, followed by a cleaning or replacement process of specific parts, and a subsequent reassembly process. In particular, the deformable forms of the device can be disassembled, and any number of specific parts or portions of the device can be selectively exchanged or removed in any combination. When cleaning and / or replacing specific parts, the deformable forms of the device can be reassembled for subsequent use either in a readjustment facility or by the surgical team immediately prior to a surgical procedure. Those skilled in the art will understand that various techniques for disassembly, cleaning / replacement, and reassembly can be utilized in the readjustment of the device. The use of such techniques, and the resulting readjusted devices, are all within the scope of this application.

[0061] Merely by way of example, the deformable forms described herein can be processed prior to surgery. First, new or used instruments can be obtained and, if necessary, cleaned. The instruments can then be sterilized. In one sterilization technique, the instruments are placed in a closed and sealed container, such as a plastic bag or a TYVEK bag. The container and the instruments can then be placed in a radiation field that can penetrate the container, such as gamma rays, X-rays, or high-energy electrons. The radiation can kill bacteria on the instruments and within the container. After this, the sterilized instruments can be stored within the sterilized container. The sealed container can keep the instruments in a sterile state until they are opened in a surgical facility. The device can also be sterilized using any other technique well known in the art, including but not limited to beta or gamma rays, ethylene oxide, or steam.

[0062] Although various modifications of the present invention have been illustrated and described, further adaptations of the methods and systems described herein can be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Some of such possible modifications have been described, but other modifications will be apparent to those skilled in the art. For example, the above-described embodiments, modifications, geometric shapes, materials, dimensions, ratios, steps, etc. are illustrative and not essential. Therefore, the scope of the present invention should be considered with respect to the following claims and it is understood that it is not limited to the details of the structures and operations shown and described in this specification and the drawings.

[0063] 〔Embodiment〕 (1) An apparatus comprising: (a) a main body; (b) a shaft assembly extending distally from the main body, the shaft assembly comprising: (i) an outer shaft including a distal opening and a slot in the distal opening; (ii) an inner tube positioned within the outer shaft, the distal opening of the inner tube being longitudinally offset from the distal opening of the outer shaft and aligned with the slot; (iii) an inner lumen positioned on the inner wall of the inner tube; (c) a position sensor; (d) a sensor cover housing the position sensor and positioned within the slot proximate to the distal opening of the inner lumen; (e) a sensor wire configured to transmit a signal from the position sensor, the sensor wire being positioned within the inner lumen, exiting the inner lumen through the distal opening of the inner lumen, entering the sensor cover, and coupling to the position sensor. (2) The apparatus according to Embodiment 1, further comprising a shaft cover that surrounds the sensor cover and the outer shaft, seals any gap where the sensor cover contacts the outer shaft, and seals any opening portion of the slot. (3) The apparatus according to Embodiment 2, including a heat trap cover, wherein the shaft cover fits loosely over the sensor cover and the outer shaft and is then adapted to be tightly sealed by heat treatment. (4) The sensor cover (i) closes most of the distal opening of the inner lumen, (ii) closes less than about 15% of the circular area of the distal opening of the outer shaft. The apparatus according to Embodiment 1. (5) The apparatus according to Embodiment 1, wherein the sensor wire is configured to translate within the inner lumen while remaining coupled to the position sensor.

[0064] (6) The inner lumen (i) The proximal opening of the inner lumen is positioned on the inner sidewall of the inner tube, (ii) The apparatus according to Embodiment 1, which is twisted along the inside of the inner tube such that the distal opening of the inner lumen is positioned at the inner top of the inner tube. (7) The apparatus according to Embodiment 1, wherein the outer shaft is made of a malleable material and the inner tube is made of a flexible material. (8) (i) The malleable material of the outer shaft includes stainless steel, (ii) The flexible material of the inner tube includes a polymer. The apparatus according to Embodiment 7. (9) The sensor cover has a diameter, the slot has a width, and the diameter of the sensor cover is larger than the width of the slot such that the sensor cover occupies the entire width of the slot. The apparatus according to Embodiment 1. (10) The longitudinal axis of the sensor cover is offset from the longitudinal axis of the inner lumen, and a portion of the sensor wire is bent at an angle to enable the sensor wire to span between the inner lumen and the offset sensor cover, the apparatus according to Embodiment 1.

[0065] (11) The diameter of the sensor wire substantially occupies the diameter of the inner lumen, the apparatus according to Embodiment 1. (12) The position sensor includes at least one coil configured to generate position data based on interaction with an alternating magnetic field and transmit the position data via the sensor wire, the apparatus according to Embodiment 1. (13) The opening of the sensor cover is angled such that the proximal edge of the sensor cover extends upward from the outer shaft at an angle less than 90 degrees, the apparatus according to Embodiment 1. (14) The body includes a longitudinal channel terminating at a distal channel opening, and the shaft assembly is positioned at the distal channel opening and coupled to the body, the apparatus according to Embodiment 1. (15) The sensor wire (i) enters a hole in the body proximate to the proximal opening of the inner lumen, (ii) enters the inner lumen through the proximal opening of the inner lumen, the apparatus according to Embodiment 1.

[0066] (16) An apparatus, (a) A shaft assembly, (i) an outer shaft having a distal opening and a slot in the distal opening, (ii) an inner tube positioned within the outer shaft, the distal opening of the inner tube being longitudinally offset from the distal opening of the outer shaft and aligned with the slot, the inner tube, (iii) an inner lumen positioned on the inner wall of the inner tube, the shaft assembly comprising, (b) A position sensor, and (c) A sensor wire configured to transmit a signal from the position sensor, wherein the sensor wire is (i) Accommodated within the inner lumen and isolated from the interior of the inner tube, (ii) Exiting the inner lumen through the distal opening of the inner lumen, passing through the slot, and coupled to the position sensor, a sensor wire, and a device. (17) The device according to embodiment 16, further comprising a sensor cover that holds the position sensor and is positioned within the slot proximate to the distal opening of the inner lumen. (18) The sensor cover is (i) Blocking most of the distal opening of the inner lumen, (ii) Blocking less than about 15% of the circular region of the distal opening of the outer shaft, the device according to embodiment 16. (19) The inner lumen is (i) The proximal opening of the inner lumen is positioned on the inner sidewall of the inner tube, (ii) Twisting along the interior of the inner tube such that the distal opening of the inner lumen is positioned at the inner top of the inner tube, the device according to embodiment 16. (20) A method for assembling a suction device, comprising (a) Coupling a shaft assembly to a body, wherein the shaft assembly is (i) An outer shaft including a distal opening and a lateral slot extending proximally from the distal opening, an outer shaft, and (ii) An inner tube positioned within the outer shaft, wherein the distal opening of the inner tube is longitudinally offset from the distal opening of the outer shaft, an inner tube, and (iii) An inner lumen positioned on the inner wall of the inner tube, and coupling; and (b) Inserting a position sensor into a sensor cover. (c) inserting the sensor cover into the slot in proximity to the distal opening of the inner lumen; (d) routing a sensor wire through the inner lumen, the sensor wire being configured to be coupled to the position sensor and to transmit a signal from the position sensor. A method comprising the foregoing.

Claims

**Claim 1** An apparatus comprising: (a) a body; (b) a shaft assembly extending distally from the body, the shaft assembly comprising: (i) an outer shaft including a distal opening and a slot extending proximally from the distal opening; (ii) an inner tube positioned within the outer shaft, the distal opening of the inner tube being longitudinally offset from the distal opening of the outer shaft and aligned with the slot; (iii) an inner lumen positioned on the inner wall of the inner tube; (c) a position sensor; (d) a sensor cover housing the position sensor and positioned within the slot proximate to the distal opening of the inner lumen; (e) a sensor wire configured to transmit a signal from the position sensor, the sensor wire being positioned within the inner lumen, exiting the inner lumen through the distal opening of the inner lumen, entering the sensor cover, and coupling to the position sensor; and further comprising a shaft cover surrounding the sensor cover and the outer shaft, sealing any gap where the sensor cover contacts the outer shaft, and sealing any open portion of the slot. **Claim 2** The apparatus of claim 1, wherein the shaft cover comprises a heat trap cover adapted to fit loosely over the sensor cover and the outer shaft and then be sealed tightly by heat treatment. **Claim 3** The apparatus of claim 1, wherein the sensor cover: (i) closes most of the distal opening of the inner lumen; (ii) closes less than 15% of the circular area of the distal opening of the outer shaft. **Claim 4** The apparatus of claim 1, wherein the sensor wire is configured to translate within the inner lumen while remaining coupled to the position sensor. **Claim 5** The apparatus of claim 1, wherein the inner lumen: (i) has a proximal opening positioned on the inner sidewall of the inner tube; (ii) twists along the inside of the inner tube such that the distal opening of the inner lumen is positioned at the inner top of the inner tube. **Claim 6** The device according to claim 1, wherein the outer shaft is made of a malleable material and the inner tube is made of a flexible material.

7. (i)The malleable material of the outer shaft includes stainless steel, (ii)The device according to claim 6, wherein the flexible material of the inner tube includes a polymer.

8. The device according to claim 1, wherein the sensor cover has a diameter, the slot has a width, and the diameter of the sensor cover is larger than the width of the slot such that the sensor cover occupies the entire width of the slot.

9. The device according to claim 1, wherein the longitudinal axis of the sensor cover is offset from the longitudinal axis of the inner lumen, and a portion of the sensor wire is bent at an angle to enable the sensor wire to span between the sensor cover offset from the inner lumen and the inner lumen.

10. The device according to claim 1, wherein the diameter of the sensor wire substantially occupies the diameter of the inner lumen.

11. The device according to claim 1, comprising at least one coil configured to generate position data based on interaction with an alternating magnetic field and transmit the position data via the sensor wire.

12. The device according to claim 1, wherein the opening of the sensor cover is angled such that the proximal edge of the sensor cover extends upward from the outer shaft at an angle of less than 90 degrees.

13. The device according to claim 1, wherein the body comprises a longitudinal channel terminating at a distal channel opening, and the shaft assembly is positioned at the distal channel opening and coupled to the body.

14. The sensor wire (i)enters a hole in the body proximate to the proximal opening of the inner lumen, (ii)enters the inner lumen through the proximal opening of the inner lumen. The device according to claim 1.

15. A device comprising (a)a shaft assembly comprising (i)an outer shaft having a distal opening and a slot extending proximally from the distal opening, (ii)an inner tube positioned within the outer shaft, wherein the distal opening of the inner tube is longitudinally offset from the distal opening of the outer shaft and aligned with the slot. (iii) an inner lumen positioned on the inner wall of the inner tube, and a shaft assembly including the same; (b) a position sensor; (c) a sensor wire configured to transmit a signal from the position sensor, the sensor wire being (i) housed within the inner lumen and isolated from the interior of the inner tube; (ii) passing out of the inner lumen through the distal opening of the inner lumen, passing through the slot, and coupling with the position sensor, a sensor wire; further comprising a sensor cover that holds the position sensor and is positioned within the slot in proximity to the distal opening of the inner lumen; further comprising a shaft cover that surrounds the sensor cover and the outer shaft, seals any gap where the sensor cover contacts the outer shaft, and seals any open portion of the slot, an apparatus.

16. The sensor cover is (i) closing most of the distal opening of the inner lumen; (ii) closing less than 15% of the circular region of the distal opening of the outer shaft, the apparatus according to claim 15.

17. The inner lumen is (i) the proximal opening of the inner lumen is positioned on the inner side wall of the inner tube; (ii) twisted along the interior of the inner tube such that the distal opening of the inner lumen is positioned at the inner top of the inner tube, the apparatus according to claim 15.

18. A method for assembling a suction device, comprising: (a) coupling a shaft assembly to a body, the shaft assembly including (i) an outer shaft including a distal opening and a lateral slot extending proximally from the distal opening; (ii) an inner tube positioned within the outer shaft, the distal opening of the inner tube being longitudinally offset from the distal opening of the outer shaft; (iii) an inner lumen positioned on the inner wall of the inner tube, coupling; (b) inserting a position sensor into a sensor cover; (c) inserting the sensor cover into the lateral slot in proximity to the distal opening of the inner lumen; (d) routing a sensor wire through the inner lumen, the sensor wire being configured to be coupled to the position sensor and transmit a signal from the position sensor; further comprising a shaft cover surrounding the sensor cover and the outer shaft, the shaft cover sealing any gap where the sensor cover contacts the outer shaft and sealing any opening of the lateral slot. A method comprising these steps.

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