Nasal suction device with replaceable tip insert
A navigable suction device integrated with image-guided navigation systems addresses the challenge of precise instrument placement in ENT and sinus surgeries by using electromagnetic sensors for real-time three-dimensional tracking, improving surgical precision and safety.
Patent Information
- Application Number
- JP2024097934
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-11-07
- Filing Date
- 2024-06-18
- Publication Date
- 2026-01-16
- Estimated Expiration
- 2039-12-02
AI Technical Summary
Existing surgical procedures, particularly in ENT and sinus surgery, face challenges in precise instrument placement due to limited two-dimensional endoscopic views, especially when conventional anatomical landmarks are absent or difficult to visualize, necessitating improved navigation systems for suction and irrigation.
Integration of a navigable suction device with image-guided surgical navigation systems, utilizing electromagnetic sensors to track the position of suction instruments in three-dimensional space, enabling real-time guidance and precise instrument placement within the patient's anatomy.
Enhances surgical precision by providing real-time, three-dimensional navigation of suction instruments, facilitating safer and more effective ENT and sinus surgeries by overcoming spatial limitations of conventional endoscopic views.
Smart Images

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Abstract
Description
[Technical Field]
[0001] (Priority) This application claims the benefit of U.S. Provisional Patent Application No. 62 / 777,799, filed December 11, 2018, the disclosure of which is incorporated herein by reference. [Background technology]
[0002] In some cases, it may be desirable to perform surgery within or adjacent to a patient's anatomical passageway, such as incising mucosa, removing bone, or widening an anatomical passageway. Such procedures may occur within anatomical passageways such as the ostium of a paranasal sinus (e.g., to treat sinusitis), the larynx, the Eustachian tube, or other passageways within the ear, nose, or throat. In addition to or similar to the above-described procedures, it may be desirable to apply suction and / or irrigation within or adjacent to the anatomical passageway before, during, or after the above-described or similar procedures. One method of applying suction within or adjacent to a patient's anatomical passageway includes obtaining a suction device having an elongate shaft defining a lumen in fluid communication with an external suction source, terminating in an open distal end of the elongate shaft. An operator can then insert the distal end of the elongate shaft into the patient's nostril or oral cavity toward the desired location within the patient. With the distal end of the elongate shaft inserted within the patient, an operator can operate the suction device and / or suction source to remove foreign and / or unwanted material adjacent to or within the patient's anatomical passageway. The application of suction and / or irrigation during surgery can be beneficial for several purposes, as will be apparent to those skilled in the art.
[0003] Image-guided surgery (IGS) is a technique that uses a computer to perform real-time correlation of the positions of inserted instruments within a patient's body to preoperatively acquired images, superimposing the current position of the instruments onto the preoperative images. In some IGS procedures, a digital tomographic scan (e.g., CT or MRI, 3D map, etc.) of the surgical field is obtained before the surgery. A specially programmed computer then converts the digital tomographic scan data into a digital map. During the surgery, special instruments equipped with sensors (e.g., electromagnetic coils that generate and / or respond to externally generated electromagnetic fields) are used to perform the procedure, while the sensors simultaneously send data to the computer indicating the current position of each surgical instrument. The computer correlates the data received from the instrument-mounted sensors with the digital map created from the preoperative tomographic scan. The tomographic scan images are displayed on a system display device (e.g., a video monitor) along with indicators (e.g., crosshairs or illuminated dots) indicating the real-time position of each surgical instrument relative to the anatomical structures depicted in the scan images. This allows the surgeon to know the exact location of each sensor-equipped instrument by viewing the video monitor, even if the surgeon cannot directly see the instrument itself in its current position within the body.
[0004] An example of an electromagnetic IGS system that can be used in ENT and sinus surgery includes the InstaTrak ENT™ system (available from GE Medical Systems, Salt Lake City, Utah). Other examples of electromagnetic image-guided systems that can be modified for use in accordance with the present disclosure include, but are not limited to, the CARTO® 3 System (Biosense-Webster, Inc., Diamond Bar, California), a system available from Surgical Navigation Technologies, Inc. (Louisville, Colorado), and a system available from Calypso Medical Technologies, Inc. (Seattle, Washington).
[0005] When applied to functional endoscopic sinus surgery (FESS), balloon sinuplasty, and / or other ENT procedures, image-guided systems allow surgeons to achieve more precise movement and placement of surgical instruments than is possible by looking through an endoscope alone. This is because a typical endoscopic image is a spatially limited, two-dimensional, line-of-sight view. Image-guided systems provide a real-time, three-dimensional view of all anatomical structures surrounding the surgical field, rather than just what is actually visible in the spatially limited, two-dimensional, direct-line-of-sight endoscopic view. As a result, image-guided systems can be particularly useful during the performance of FESS, balloon sinuplasty, and / or other ENT procedures where suction and / or irrigation sources may be desirable, especially when conventional anatomical landmarks are absent or difficult to visualize endoscopically.
[0006] It may be desirable to provide features that further facilitate the use of IGS navigation systems and associated components in ENT and other medical procedures. Although several systems and methods have been made and used in connection with IGS and ENT surgery, it is believed that no one prior to the present inventors has made and used the invention as set forth in the accompanying claims. [Brief explanation of the drawings]
[0007] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention. [Figure 1] 1 shows a schematic diagram of an exemplary sinus surgery navigation system. [Figure 2] 2 shows a perspective view of an exemplary assembly having a suction apparatus and a coupling unit for coupling the suction apparatus with the navigation system of FIG. 1; [Figure 3] 3 shows an exploded perspective view of the suction device of FIG. 2. [Figure 4] 4 shows a cross-sectional perspective view of the suction apparatus of FIG. 2 taken along line 4-4 of FIG. 2. [Figure 5] 3 shows a cross-sectional perspective view of the handle assembly of the instrument of FIG. 2. [Figure 6A] 10 shows a perspective view of another exemplary suction instrument suitable for use with the navigation system of FIG. 1, showing a distal suction attachment coupled to a proximal handle assembly. [Figure 6B] 6B illustrates another perspective view of the suction instrument of FIG. 6A, showing the distal suction attachment separated from the proximal handle assembly. [Figure 7] 6B illustrates another perspective view of the suction instrument of FIG. 6A, showing the distal suction attachment separated from the proximal handle assembly. [Figure 8] 8 shows a top cross-sectional view of the handle assembly of the suction instrument of FIG. 6A taken along line 8-8 of FIG. 7. [Figure 9]6B shows a perspective view of the proximal end of the distal suction attachment of the suction instrument of FIG. 6A, with the connector block of the suction attachment shown in phantom to show the features located within the connector block. [Figure 10] 10 shows a side cross-sectional view of the suction instrument of FIG. 6A taken along section line 10-10 of FIG. 6A, showing the distal suction attachment coupled to the proximal handle assembly. [Figure 11] 1. FIG. 10 illustrates a perspective view of another exemplary suction instrument suitable for use with the navigation system of FIG. 1, showing the distal suction attachment separated from the proximal handle assembly. [Figure 12] 12 shows an enlarged perspective view of the connection between the proximal handle assembly and the distal suction attachment of the suction instrument of FIG. 11.
[0008] The drawings are not intended to be limiting in any manner, and it is contemplated that various embodiments of the invention may be embodied in a variety of 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 several aspects of the invention and, together with the description, serve to explain the principles of the invention. It will be understood, however, that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION OF THE INVENTION
[0009] The following description of specific examples of the present invention should not be used for the purpose of limiting the scope of the present invention. Other examples, features / features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which illustrates, by way of example, one of the best modes contemplated for carrying out the invention. As will be understood, the present invention is capable of other different and obvious aspects, e.g., various, without any departing from the present invention. Accordingly, the drawings and description should be regarded as illustrative in nature and not as restrictive.
[0010] For clarity of this disclosure, the terms "proximal" and "distal" are defined herein relative to a surgeon or other operator grasping a surgical instrument having a distal surgical end effector. The term "proximal" refers to the location of elements disposed closer to the surgeon, and the term "distal" refers to the location of elements disposed closer to the surgical end effector of the surgical instrument and farther from the surgeon. Also, to the extent spatial terms such as "top," "bottom," "upper," "lower," "vertical," and "horizontal" are used herein with reference to the drawings, it will be understood that such terms are used for illustrative and descriptive purposes only and are not intended to be limiting or absolute. In that regard, it will be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions, not limited to those shown and described herein.
[0011] As used herein, the term "about" or "approximately" of any numerical value or range is intended to encompass not only the exact value(s) referenced, but also a suitable dimensional tolerance that enables the portion or collection of components to function for its intended purpose as described herein.
[0012] I. Exemplary Image-Guided Surgical Navigation System When performing a medical procedure within the head (H) of a patient (P), it may be desirable to have information regarding the location of an instrument within the head (H) of the patient (P), especially when the instrument is located in a location where it is difficult or impossible to obtain an endoscopic view of the instrument's working element within the head (H) of the patient (P). FIG. 1 illustrates an exemplary IGS navigation system (10) that enables the performance of an ENT procedure 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 operative in accordance with at least some of the teachings of the following documents: 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); 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).
[0013] The IGS navigation system (10) of this example includes a magnetic field generator assembly (12) including a magnetic field generator (16) integrated into a horseshoe-shaped frame (14). The magnetic field generator (16) is operable to generate alternating magnetic fields of different frequencies around the head (H) of a patient (P). In this example, a navigation guidewire (30) is inserted into the head (H) of the patient (P). The navigation guidewire (30) may be a stand-alone device or may be located in an end effector of a medical instrument, such as a surgical cutting or dilating instrument, or elsewhere. In this example, the frame (14) is mounted to a chair (40), and the patient (P) is seated in the chair (40) such that the frame (14) is positioned adjacent to the patient's (P) head (H). By way of example only, chair (40) and / or magnetic field generator assembly (12) may be configured and operable in accordance with at least some of the teachings of U.S. patent application Ser. No. 15 / 933,737, entitled "Apparatus to Secure Field Generating Device to Chair," filed March 23, 2018, the disclosure of which is incorporated herein by reference.
[0014] The IGS navigation system 10 of this example further includes a processor 18 that controls the magnetic field generator 16 and other elements of the IGS navigation system 10. For example, the processor 18 is operable to drive the magnetic field generator 16 to generate an alternating electromagnetic field and to process signals from the navigation guidewire 30 to determine the location of sensors in the navigation guidewire 30 within the head H of the patient P. The processor 18 includes a processing unit in communication with one or more memories. The processor 18 of this example is mounted within a console 20 that includes motion controls 22, which may include a keypad and / or a pointing device such as a mouse or trackball. A surgeon uses the motion controls 22 to interact with the processor 18 while performing a surgical procedure.
[0015] The navigation guidewire 30 includes a sensor (not shown) that responds to positioning within the alternating electromagnetic field generated by the magnetic field generator 16. A coupling unit 26 is secured to the proximal end of the navigation guidewire 30 and is configured to provide for communication of data and other signals between the console 20 and the navigation guidewire 30. The coupling unit 26 may provide for wired or wireless communication of data and other signals between the console 20 and the navigation guidewire 30.
[0016] In this example, the sensor of the navigation guidewire 30 includes at least one conductive coil at the distal end of the navigation guidewire 30. When such a coil is placed within an alternating electromagnetic field generated by the magnetic field generator 16, the alternating magnetic field generates an electric current in the coil, which can then be transmitted proximally along conductive path(s) within the navigation guidewire 30 to the processor 18 via the coupling unit 26. This phenomenon enables the IGS navigation system 10 to determine the location of the distal end of the navigation guidewire 30 or other medical instrument (e.g., a dilation instrument, a surgical cutting instrument, etc.) in three-dimensional space (i.e., within the head (H) of the patient (P)). To accomplish this, the processor 18 executes an algorithm that calculates the position coordinates of the distal end of the navigation guidewire 30 from the position-related signals of the coil(s) within the navigation guidewire 30. In this embodiment, the position sensor is located within the guidewire (30), although such position sensors may be integrated into a variety of other types of devices, including those described in more detail below.
[0017] The processor 18 calibrates and operates the IGS navigation system 10 using software stored in the processor's memory. Such operations include driving the magnetic field generator 16, processing data from the navigation guidewire 30, processing data from the motion control 22, and driving the display screen 24. In some implementations, operations may also include monitoring and enforcing one or more safety features or functions of the IGS navigation system 10. The processor 18 is further operable to provide real-time video via the display screen 24 showing the position of the distal end of the navigation guidewire 30 relative 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 patient's nasal cavity and the anatomical structures adjacent to the patient's nasal cavity. The display screen 24 can display such images 28 simultaneously and / or overlaid on each other during a surgical procedure. The image (28) thus displayed may also include a graphical representation of an instrument being inserted into the patient's head (H), such as a navigation guidewire (30), allowing the operator to view a virtual rendering of the instrument in its actual location in real time. By way of example only, the display screen (24) may provide the image (28) in accordance with at least some of the teachings of U.S. Patent Application Publication No. 2016 / 0008083, entitled "Guidewire Navigation for Sinuplasty," published January 14, 2016, the disclosure of which is incorporated herein by reference. If the operator is also using an endoscope, endoscopic images may also be displayed on the display screen (24).
[0018] The image 28 provided by the display screen 24 may help guide the operator in steering and otherwise maneuvering the instrument within the patient's head H if the instrument incorporates a navigation guidewire 30. It should also be understood that other components of surgical instruments and other types of surgical instruments may incorporate sensors, such as the sensor of the navigation guidewire 30, as described below.
[0019] II. Exemplary Navigable Suction Device Various surgical procedures may require the use of suction instruments to remove fluids and / or debris from the surgical field and / or other locations within a patient. For example, it may be desirable to provide suction in FESS surgery, sinuplasty, and / or various other ENT procedures. Additionally, in some cases, it may be desirable to provide image-guided navigation capabilities for such suction instruments.
[0020] 2 illustrates an exemplary suction instrument assembly (100) operable to apply suction during a surgical procedure and configured for use with the above-described IGS navigation system (10). The suction instrument assembly (100) includes a suction instrument (110) fluidly coupled to a suction source (80) via a conduit (90). The suction source (80) may include a vacuum pump and a fluid reservoir, among other components readily apparent to those skilled in the art, and is configured to apply sufficient suction to the surgical site to draw excess fluid and / or debris proximally through the suction instrument (110).
[0021] As shown in FIGS. 2 and 3 , the suction instrument 110 includes a coupling unit 120, a proximal suction conduit port 130, a gripping portion (or “handle assembly”) 140, and an elongated cannula assembly 160. The distal end of the cannula assembly 160 is configured to be inserted transnasally or otherwise into or adjacent to a patient's nasal cavity (or elsewhere within the patient) to apply suction to a selected surgical site. The cannula assembly 160 has a sensor assembly 190 attached to its distal end. As described below, the sensor assembly 190 includes a navigation sensor operable to transmit signals to the console 20 of the IGS navigation system 10 via the coupling unit 120. Based on these signals, the processor 18 can execute an algorithm to determine the three-dimensional spatial position of the distal end of the cannula assembly 160 relative to the anatomy of the patient P.
[0022] The connection unit 120 includes a sensor coupling 122, a console coupling 124, and a cable 126 connecting the sensor coupling 122 and the console coupling 124 and establishing communication therebetween. The sensor coupling 122 includes a prong 128 received within a proximal cavity 156 of the grip portion 140. The console coupling 124 is configured to couple with the console 20, and the sensor coupling 122 is configured to couple with the sensor assembly 190 of the suction instrument 110, thereby enabling the sensor assembly 190 to communicate with the console 20. The console coupling 124, like the connection unit 26 described above, can communicate with the console 20 via wired or wireless communication. Additionally, the connection unit 120 can be configured to communicate data or other signals unidirectionally or bidirectionally between the suction instrument 110 and the console 20.
[0023] The proximal suction conduit port 130 includes a proximal barb structure 132, a distal shaft 134, and an interior passageway 136. The proximal barb structure 132 is configured to provide a secure fit with the conduit 90 such that the passageway 136 and the interior of the conduit 90 are in fluid communication with each other.
[0024] As best seen in Figures 2-5, the gripping portion (140) includes a body (142) and a proximal cap (145). The body (142) is grasped by an operator to allow the operator to operate and control the suction instrument (110). The body (142) defines a first vent opening (144), a distal opening (146), a proximal cavity (156), and a passageway (154) extending from the distal opening (146) into the proximal cavity (156). The proximal cap (145) is attached to a proximal portion of the body (142) and closes the proximal cavity (156). The proximal cap (145) has a first proximal opening (148) that receives the shaft (134) of the proximal suction conduit port (130) and a second proximal opening (150) that receives the sensor coupling (122) of the connection unit (120). As shown in FIG. 5, the passageway (154) has a shoulder (152) formed distally therein that is configured to abut the open proximal end (166) of the outer sheath (162) of the cannula assembly (160) when the cannula assembly (160) is inserted proximally through the distal opening (146) during assembly.
[0025] The elongate cannula assembly (160) includes an outer sheath (162), an inner suction tube (170), a sensor assembly (190), and a distal cap (184) that covers the sensor assembly (190). The outer sheath (162) extends from an open distal end (164) to an open proximal end (166) with a bent portion (165) located therebetween. The outer sheath (162) defines a hollow interior that accommodates a portion of the inner suction tube (170) and a portion of a communication wire (196) that extends within and along a guide passage (180) defined by the inner suction tube (170).
[0026] The inner suction tube (170) extends from an open distal end (174) to an open proximal end (176) with a bent portion (175) disposed therebetween. As shown in FIG. 4, the inner suction tube (170) has a small diameter distal portion (172) that extends distally of the open distal end (164) of the outer sheath (162) and through the sensor assembly (190), which is secured to the small diameter distal portion (172). As shown in FIG. 3, the inner suction tube (170) and the outer sheath (162) define a guide channel (180) that accommodates a communication wire (196) extending proximally from the sensor assembly (190). The suction tube (170) and outer sheath (162) may be rigid and configured to maintain bending of the bent regions (165, 175) without buckling during insertion into a patient's nasal cavity.
[0027] As shown in Figure 4, the inner suction tube (170) defines a suction lumen (178) extending from an open distal end (174) to an open proximal end (176). A proximal portion of the inner suction tube (170) is received through the distal opening (146) of the gripping portion body (142) and extends proximally into the passageway (136) of the suction conduit port (130), with the suction lumen (178) configured to be fluidly coupled with the suction source (80) via the suction conduit (90). As shown in Figures 3 and 4, the first vent opening (144) of the gripping portion (140) is in fluid communication with the suction lumen (178) through a second vent opening (182) formed in the suction tube (170). During operation, an operator can grasp grip portion (140) and selectively close first vent opening (144) to transfer suction from suction source (80) to suction lumen (178). As shown, first vent opening (144) can be formed in a teardrop shape (or some other elongated shape), thereby allowing the operator to selectively vary the amount of suction transferred from suction source (80) to suction lumen (178) based on the longitudinal position of the operator's thumb (or finger) over first vent opening (144).
[0028] In some cases, the suction source (80) remains activated throughout the entire surgical procedure. In such instances, the operator may keep the first vent opening (144) uncovered while placing the open distal end (174) of the instrument (110) within the patient, so that the suction source (80) draws suction through the vent openings (144, 182) rather than through the open distal end (174). When the operator desires to apply suction to a target surgical site within the patient via the open distal end (174), the operator at least partially covers the vent opening (144) with a thumb, finger, or other object, thereby allowing suction to be transferred from the suction source (80) to the open distal end (174).
[0029] The sensor assembly (190) of the cannula assembly (160) may include an annular navigation sensor (not shown) according to the teachings of U.S. patent application Ser. No. 15 / 964,886, filed April 27, 2018, and entitled "Navigable Suction Instrument With Coaxial Annular Sensor," the disclosure of which is incorporated herein by reference. The navigation sensor may include one or more electrically conductive members, such as coils or layers of wire windings, in which a current is induced in response to the presence of the sensor assembly (190) in an electromagnetic field generated by the magnetic field generator (16) of the IGS navigation system (10). One or more sensor wires (not shown) extend proximally from the sensor assembly (190) through the cannula assembly (160) and are coupled to the communication wire (196), extending along the guide channel (180) and into the proximal cavity (156) of the gripping portion (140), as shown in FIG. 5 . The communication wires 196 are coupled to the PCB board 195, which is further coupled to the prongs 128 of the sensor coupling 122. As mentioned above, the coupling unit 120 is configured to communicate with the console 20 of the IGS navigation system 10.
[0030] The current induced in the navigation sensor of the sensor assembly 190 is transmitted as an electrical signal proximally through the sensor wire to the communication wire 196 and through the PCB board 195 to the connection unit 120, which transmits the signal to the console 20 of the IGS navigation system 10. The processor 18 then executes an algorithm to calculate three-dimensional position coordinates of the navigation sensor based on the received electrical signal. Because the sensor assembly 190 is secured to the distal end 174 of the elongated cannula assembly 160, the IGS navigation system 10 can calculate, track, and display the position of at least the distal end within the patient P in real time during a surgical procedure. While tracking the position of the cannula assembly 160 within the patient P, the operator can selectively apply suction at any appropriate time in accordance with the teachings above. It will be appreciated that the suction apparatus assembly (100) may further be constructed and operated in accordance with one or more of the teachings of US Patent Application Publication No. 15 / 964,886.
[0031] III. Exemplary Navigable Suction Instrument with Detachable Suction Tip As discussed above in connection with the suction instrument 110, the gripping portion 140 and the cannula assembly 160 are permanently coupled mechanically and electrically when assembled to form a single unit manipulated by an operator. In some cases, it may be desirable to configure these components modularly, e.g., alternatively, the gripping portion 140 and the cannula assembly 160 so that they can be selectively separated from one another by an operator during a surgical procedure. For example, it may be desirable to use different cannula assemblies 160 having different bend angles at their respective bend portions 165 to facilitate access to different anatomical regions during a surgical procedure.
[0032] Additionally, allowing selective coupling between the grip portion (140) and the cannula assembly (160) can facilitate a disposable / reusable dichotomy between the grip portion (140) and the cannula assembly (160). For example, the modular grip portion (140) may be non-reusable or reusable a specific first limited number of times, while the modular cannula assembly (160) may be non-reusable or reusable a specific second limited number of times. The following description provides merely exemplary illustrations of how the suction apparatus (110) may be modified to allow selective coupling between the modular grip portion (140) and the modular cannula assembly (160).
[0033] A. Navigable suction instrument with suction attachment having connector block 6A-7 illustrate an exemplary alternative suction instrument (210) having a gripping portion (or "handle assembly") (220) and a suction attachment (260) configured to releasably couple to the handle assembly (220), as described in more detail below. It will be appreciated that the suction instrument (210) is similar to the suction instrument (110) described above, except as otherwise described below. As shown in FIGS. 6A-8, the handle assembly (220) has a body (222) defining an internal cavity (224) and a proximal cap (226) coupled to the proximal end of the body (222). As best seen in FIG. 8, an inner tubular structure (228) extends longitudinally through the internal cavity (224) to define a suction passageway (230) similar to the passageway (154) of the handle assembly (140) described above. The inner tubular structure 228 is suitably positioned within the body 222 such that the distal end of the suction passage 230 opens into the distal end of the handle assembly body 222 and the proximal end of the suction passage 230 opens into the proximal end of the body 222 through the proximal cap 226. As shown in Figures 6A-7, a vent opening 232 extends through the top surface of the body 222 and opens into the suction passage 230. The vent opening 232 is suitably shaped and configured to be selectively covered by an operator in a manner similar to that described above in connection with the suction instrument 110 to transmit suction from the suction source 80 to the suction lumen 284 of the suction attachment 260.
[0034] As best seen in Figures 7, 8, and 10, the proximal end of the handle assembly body 222 houses an interlocking connector 234 within a proximal portion of the internal cavity 224, with the interlocking connector 234 accessible through a proximal cap 226. The interlocking connector 234 is configured to releasably receive and electrically couple with the above-described coupling unit 120 or a similar coupling device, enabling the handle assembly 220 to communicate with the console 20 of the IGS navigation system 10. In some variations, the interlocking connector 234 may include a LEMO® connector. It should be understood that the interlocking connector 234 is optional, and that in some alternative variations, the distal end of the coupling unit 120 may be integral with the handle assembly 220.
[0035] As best seen in FIGS. 6B and 8, the distal end of the handle assembly body 222 houses a pair of electrical connectors 236 a, 236 b within the distal portion of the internal cavity 224. The electrical connectors 236 a, 236 b are exposed from the distal face 223 of the body 222 and are positioned on either side of the open distal end of the suction passage 230. As described in more detail below, each electrical connector 236 a, 236 b is configured to electrically couple with a respective electrical connector 304 a, 304 b of the suction attachment 260 when the suction attachment 260 is coupled to the handle assembly 220. As shown in FIG. 8, the body 222 further houses within the cavity 224 a PCB board 238 (shown schematically), which may be similar to the PCB board 195 described above. One or both of the electrical connectors (236a, 236b) are electrically coupled to a PCB substrate (238), which is further electrically coupled to a mating connector (234).
[0036] The handle assembly body 222 of this example further houses an electrically erasable programmable read-only memory (EEPROM) 240 within the internal cavity 224. The handle EEPROM 240 is operable to store data related to the handle assembly 220, such as the serial number and / or past usage history of the handle assembly 220. The handle EEPROM 240 is electrically coupled to a PCB board 238, which is further configured to communicate with an external processor, such as the processor 18 of the navigation system 10, via the electrical connector 234 and the coupling unit 120.
[0037] The handle assembly (220) of this example further includes a first coupling mechanism consisting of a pair of recessed grooves (242) formed on opposite sides of the distal portion of the handle assembly body (222). The recessed grooves (242) are configured to releasably receive the second coupling mechanism (308) of the suction attachment (260) when the suction attachment (260) is coupled to the handle assembly (220). As described in more detail below, this engagement of the coupling mechanisms (242, 308) facilitates alignment of the handle assembly's electrical connectors (236a, 236b) with the suction attachment's electrical connectors (304a, 304b) and of the suction lumen (284) of the cannula assembly (270) with the suction passageway (230) of the handle assembly (220).
[0038] A suction conduit port 250, similar to the suction conduit port 130 described above, extends proximally from the handle assembly body 222. The suction conduit port 250 has a proximal barbed portion 252 and a distal shaft portion 254. The proximal barbed portion 252 is configured to couple with the suction conduit 90, and the distal shaft portion 254 is inserted into an upper opening formed in the proximal cap 226 of the handle assembly 220, thereby placing the internal passage of the suction conduit port 250 in fluid communication with the suction passage 230 of the handle assembly 220. The suction conduit port 250 is therefore configured to transmit suction from the suction source 80 and the suction conduit 90 to the suction passage 230 of the handle assembly 220.
[0039] The suction attachment (260) of the suction instrument (210) includes an elongated cannula assembly (270) and a connector block (300) attached to a proximal portion of the cannula assembly (270). The cannula assembly (270) extends between an open proximal end (272) and an open distal end (274) with a bent portion (276) located therebetween. The cannula assembly (270) is similar to the cannula assembly (160) described above in that the cannula assembly (270) includes an outer sheath (280), an inner suction tube (282) defining an aspiration lumen (284), a sensor assembly (290) attached to the open distal end (274), and a distal cap (294) circumferentially surrounding the sensor assembly (290). The outer sheath 280 and the inner suction tube 282 include hollow interiors and extend between the open proximal end 272 and the open distal end 274 of the cannula assembly 270. Additionally, the outer sheath 280 and / or the inner suction tube 282 may comprise a rigid structure that maintains the bending angle of the bending portion 276 without buckling when the cannula assembly 270 is inserted into a patient's nasal cavity. Unlike the suction tube 170 of the suction instrument 110, the suction tube 282 in this example is not configured to extend the entire length of the handle assembly body 222 into the suction conduit port 250 when the suction attachment 260 is coupled to the handle assembly 220. 9 and 10, the suction tube (282) terminates just proximal to the proximal face (302) of the connector block (300) and is configured to be inserted into only the distal portion of the suction passage (230) of the handle assembly body (222) during assembly of the suction instrument (210). Such a configuration is advantageous because it minimizes the length of the proximal portion of the cannula assembly (270).
[0040] The sensor assembly (290) of the cannula assembly (270) may include components similar to those of the sensor assembly (190) described above, including a navigation sensor (292). The navigation sensor (292) is operable to transmit electrical signals to the console (20) of the IGS navigation system (10) such that the processor (18) can execute an algorithm to determine the three-dimensional spatial position of the navigation sensor (292), and therefore the distal end (274) of the cannula assembly (270), relative to the anatomy of the patient (P). The navigation sensor (292) may include one or more electrically inductive members, such as coils, layers of wire windings, etc., in which an electrical current is induced in response to the presence of the navigation sensor (292) in an electromagnetic field generated by the magnetic field generator (16) of the IGS navigation system (10). By way of example only, navigation sensor (292) may include an annular sensor of the type disclosed in US Patent Application Publication No. 15 / 964,886, incorporated above by reference.
[0041] As best seen in FIG. 9 , the connector block 300 of the suction attachment 260 is attached to a proximal portion of the cannula assembly 270, which extends through the connector block 300 to expose an open proximal end 272 at a proximal face 302 of the connector block 300. The connector block 300 houses a pair of electrical connectors 304 a, 304 b exposed at the proximal face 302 and positioned on either side of the open proximal end 272. In this variation, as described below, the electrical connector 304 a is electrically coupled to the navigation sensor 292 of the sensor assembly 290, while the electrical connector 304 b is electrically coupled to an EEPROM 306 housed within the connector block 300. The electrical connector 304a may be coupled to the navigation sensor 292 via a wire (not shown) similar to the communication wire 196 described above. Such a wire may extend longitudinally along the cannula assembly 270 through a passage defined between the outer surface of the inner suction tube 282 and the inner surface of the outer sheath 280. Each electrical connector 304a, 304b is configured to be electrically coupled to a respective electrical connector 236a, 236b of the handle assembly 220 when the suction attachment 260 is coupled to the handle assembly 220.
[0042] In this variation, the handle assembly electrical connectors 236a, 236b are shown in the form of female connectors with electrical sockets, while the suction attachment electrical connectors 304a, 304b are shown in the form of male connectors with pins configured to be received in the sockets. It will be appreciated that various other suitable configurations of the electrical connectors 236a, 236b, 304a, 304b may be used in other variations. For example, the handle assembly 220 and the connector block 300 may each include one female electrical connector and one male electrical connector. Alternatively, as described below, the handle assembly 220 and the connector block 300 may each include a single electrical connector including the same number of pins and sockets as were included in the electrical connectors 236a, 236b, 304a, 304b. Thus, each electrical connector 236a, 236b, 304a, 304b may have any suitable quantity and arrangement of pins or sockets. By way of example only, the electrical connectors (236a, 236b, 304a, 304b) may include connectors by Mill-Max, Mfg. Corp. of Oyster Bay, New York.
[0043] 9, connector block 300 of suction attachment 260 further houses a second EEPROM 306 operable to store data regarding suction attachment 260. Such data may include a serial number, the bending angle of bending portion 276 of cannula assembly 270, the distance of sensor assembly 290 from connector block 300 or another reference point, other physical characteristics of suction attachment 260, and / or previous use of suction attachment 260. In this example, attachment EEPROM 306 is electrically coupled to electrical connector 304b of connector block 300. Thus, as described above, when electrical connector 304b is coupled with electrical connector 236b of handle assembly 220, attachment EEPROM 306 is in communication with PCB board 238, which is further configured to communicate with processor 18 of navigation system 10 via electrical connector 234. In some alternative variations of suction instrument 210, handle assembly 220 and suction attachment 260 may each include a single electrical connector having electrical contacts that transmit electrical signals to navigation sensor 292 and attachment EEPROM 306. In such variations, mixed signals received by handle assembly 220 may be separated by processing with signal filtering devices (not shown) located internal or external to handle assembly 220.
[0044] In some cases, it may be desirable to discard or sterilize the suction attachment (260) after a maximum period of use (e.g., after one or more uses). In that regard, and as noted above, the attachment's EEPROM (306) may be operable to track and store data regarding the use of the suction attachment (260). In some variations, the attachment's EEPROM (306) may be configured to instruct a notification function to provide an indication to the operator that the maximum period of use has been reached, in which case the suction attachment (260) should be sterilized or discarded without further use. Alternatively, or in addition, the attachment EEPROM (306) may be configured to instruct a disabling function to prevent or otherwise limit further use of the suction attachment (260) upon reaching the maximum period of use. Such notification and disabling functions may be incorporated as part of the suction apparatus (210) or may be provided separately from the suction apparatus (210). It will be appreciated that similar usage notification and / or usage override features may be provided in connection with the handle assembly 220 and the handle EEPROM 240. For example, by way of example only, the suction attachment 260 may be used more than once before requiring disinfection or disposal, and the handle assembly 220 may be used more than 100 times before requiring disinfection or disposal. Additionally, the attachment EEPROM 306 and / or the handle EEPROM 240 may include one or more safety features coded in software that prevent an end user from overriding the override feature(s) or notification feature(s).
[0045] In some variations, a processor external to the handle assembly 220 or handle assembly 22, such as the processor 18 of the navigation system 10, can be appropriately configured to prevent unrecognized attachments from being used with the handle assembly 220. For example, the handle assembly PCB board 238 or the navigation system processor 18 can be configured to identify a serial number stored by the attachment's EEPROM 306 and check the identified serial number against a database of acceptable serial numbers. If the identified serial number is not included in the database, or if the distal attachment does not have a serial number stored therein (e.g., if the EEPROM 306 is omitted entirely from the attachment), the handle assembly 220, suction attachment 260, and / or suction source 80 can be automatically disabled via a disable function.
[0046] It will be appreciated that additional EEPROMs may be provided throughout various other portions of the suction device 210, the connecting unit 120, and / or the IGS navigation system 10, as desired. For example, a first additional EEPROM may be provided in the cable 126 of the connecting unit 120 and configured to store data related to the connecting unit 120. A second additional EEPROM may be provided in a connecting device (e.g., a "dongle") that connects the connecting device 120 to the console 20 of the IGS navigation system 10 and may be configured to amplify signals transmitted between the connecting unit 120 and the console 20.
[0047] 6A-7 and 8, the connector block 300 of the suction attachment 260 further includes a coupling mechanism in the form of a pair of prong-like arms 308 projecting proximally from opposite sides of the proximal face 302. Each arm 308 is configured to slide longitudinally into a corresponding one of the recessed channels 242 in the handle assembly body 222. Such engagement of the arms 308 with the recessed channels 242 facilitates alignment of the suction attachment's electrical connectors 304a, 304b with the handle assembly's electrical connectors 236a, 236b. The engagement of the arms 308 with the recessed grooves 242 also promotes coaxial alignment of the open proximal end 272 of the cannula assembly 270 with the open distal end of the aspiration passageway 230 of the handle assembly 220, such that the aspiration passageway 230 is in fluid communication with the aspiration lumen 284 when the aspiration attachment 260 and the handle assembly 220 are fully engaged. While the handle assembly 220 and connector block 300 of this variation are shown with coupling mechanisms in the form of recessed grooves 242 and arms 308, it will be appreciated that in other variations, various other types of coupling mechanisms may be used.
[0048] 6A-7 and 10, full engagement of the suction attachment (260) with the handle assembly (220) functions to electrically couple the suction attachment's electrical connectors (236a, 236b) with the handle assembly's electrical connectors (236a, 236b) and fluidly couple the suction lumen (284) of the suction attachment (260) with the handle assembly's suction passageway (230). As shown in FIG. 10, the open proximal end (272) of the cannula assembly (270), including the proximal end of the suction tube (282), protrudes slightly into the handle assembly's body (222) to establish fluid communication between the suction lumen (284) and the suction passageway (230). Thus, suction can be transmitted from the suction source 80 through the suction passageway 230 to the suction lumen 284 to aspirate fluid and / or debris through the open distal end 274 of the cannula assembly 270 and away from the surgical site where the open distal end 274 is positioned by an operator. The operator can control the amount of suction transmitted to the open distal end 274 by selectively covering the vent openings 232 as described above. Simultaneously, the navigation sensor 292 is configured to interact with the electromagnetic field generated around the patient's head H by the magnetic field generator 16 (see FIG. 1 ) to generate an electrical signal that is transmitted through the cannula assembly 270, the handle assembly 220, and the connection unit 120 to the console 20 of the IGS navigation system 10. In response to receiving these signals, the processor (18) can then determine and display on the display (24) the three-dimensional spatial position of the open distal end (274) relative to the anatomy of the patient (P).
[0049] In some variations, the connector block 300 and / or the handle assembly body 222 of the suction instrument 210 may include a locking mechanism (not shown) that functions to strengthen the mechanical connection between the handle assembly 220 and the connector block 300 by releasably retaining the arms 308 within the recessed channels 242 when the connector block 300 and the handle assembly 220 are fully pushed together. Such a locking mechanism may be configured to allow separation of the connector block 300 from the handle assembly body 222 only in response to an operator's actions intentionally separating the suction attachment 260 from the handle assembly 220. The locking mechanism may be further configured to maintain the distal surface 223 of the handle assembly body 222 in sufficient proximity to the proximal surface 302 of the suction attachment 260 to prevent liquid from contacting and shorting the electrical connectors 236a, 236b and to prevent air, liquid, and other debris from escaping from the interface between the suction lumen 284 and the suction passageway 230 (see FIG. 10). Such a locking mechanism may include one or more latches, detents, magnets, or other suitable mechanisms that will be readily apparent to those skilled in the art in view of the teachings herein. The locking mechanism may be incorporated into the arm 308 and recessed groove 242 or into other portions of the connector block 300 and handle assembly body 222.
[0050] Additionally, in some variations, the handle assembly 220 and / or the suction attachment 260 may include one or more electrical seals (not shown) configured to prevent liquid from contacting and shorting the electrical connectors 236 a, 236 b, 304 a, 304 b. Such electrical seals may surround one or more of the electrical connectors 236 a, 236 b on the distal surface 223 of the handle assembly body 222 and / or one or more electrical connectors 304 a, 304 b on the proximal surface 302 of the connector block 300. Such seals may include any suitable material, such as foam or rubber, configured to resiliently compress between the surfaces 223, 302 when the suction attachment 260 is fully attached to the handle assembly 220. Additionally, the suction instrument 210 may include a suction seal (not shown) configured to prevent leakage of air, liquid, and debris from the junction between the suction lumen 284 of the cannula assembly 270 and the suction passageway 230 of the handle assembly 220. Such a suction seal may be provided in the form of an O-ring seal disposed within the open proximal end 272 of the cannula assembly 270 or the open distal end of the suction passageway 230. It will be appreciated that various other forms of seals and gasket-like structures may be provided at the interface between the handle assembly 220 and the suction attachment 260 to prevent leakage of the suction flow path and protect the electrical connectors 236a, 236b, 304a, 304b from shorting.
[0051] B. Navigable Suction Instrument Having a Detachable Cannula Assembly with Integrated Electrical Contacts In some cases, it may be desirable to omit the connector block (300) from the suction instrument (210) to provide a more size-efficient version of the suction attachment (260). Figures 11-12 illustrate an exemplary alternative navigational suction instrument (310) having a handle assembly (320) and a detachable cannula assembly (350) suitably configured to releasably couple directly to the handle assembly (320) at its proximal end (352). The handle assembly (320) is similar to the handle assembly (220) described above in that the handle assembly (320) includes a body (322) defining an internal cavity (not shown) and a proximal cap (324) coupled to the proximal end of the body (322). A suction passage (326) extends longitudinally through the body (322) and is in fluid communication with a vent opening (328) formed in the upper surface of the body (322). A suction conduit port (340) extends proximally from the proximal cap (324) and is configured to connect with the suction conduit (90) to fluidly connect the suction passage (326) of the handle assembly (320) with the suction source (80).
[0052] As described below, the distal surface 323 of the handle assembly body 322 includes an attachment port 330 configured to releasably receive the proximal end 352 of the cannula assembly 350. The attachment port 330 in this example includes an annular recessed shoulder 332 that defines the open distal end of the aspiration passage 326, and a pair of electrical contacts in the form of an electrical socket 334 disposed within the recessed shoulder 332. The electrical socket 334 is electrically coupled to one or more electrical elements housed within the handle assembly body 322, which may include components similar to the mating connector 234, PCB board 238, and handle EEPROM 240 of the handle assembly 220 described above. It will be appreciated that various suitable types of electrical contacts other than socket (334) may be provided on recessed shoulder (332) or the sidewall surrounding recessed shoulder (332) of other variations of handle assembly (320).
[0053] The removable cannula assembly (350) is similar to the cannula assembly (270) described above in that the removable cannula assembly (350) extends between an open proximal end (352) and an open distal end (354) with a bent portion (356) disposed therebetween. Additionally, the removable cannula assembly (350) includes an outer sheath (360), an inner suction tube (362) defining an aspiration lumen (364), a sensor assembly (370) disposed at the open distal end (354) and including a navigation sensor (372), and a distal cap (374) circumferentially surrounding the sensor assembly (370). These elements may be similar to the corresponding elements of the cannula assembly (270) described above.
[0054] The open proximal end 352 of the detachable cannula assembly 350 includes an integral pair of electrical contacts in the form of proximally protruding pins 380. The electrical pins 380 are electrically coupled to the navigational sensors 372 and, optionally, to an EEPROM (not shown) housed within or otherwise coupled to a portion of the cannula assembly 350, which may be similar to the EEPROM 306 of the attachment described above. It will be appreciated that various suitable types of electrical contacts other than pins 380 may be provided on other variations of the open proximal end 352. For example, the open proximal end 352 may include one or more electrical contact sockets configured to receive one or more electrical contact pins protruding from the recessed shoulder 332 of the handle assembly 320.
[0055] The open proximal end (352) of the detachable cannula assembly (350) is configured to be releasably received within the attachment port (330) of the handle assembly (320) to securely mechanically and electrically couple the cannula assembly (350) to the handle assembly (320). Specifically, the proximal face of the open proximal end (352) abuts the recessed shoulder (332) in the attachment port (330), such that the aspiration lumen (364) of the cannula assembly (350) is fluidly coupled to the aspiration passageway (326) of the handle assembly (320), and the electrical pin (380) of the cannula assembly (350) is received within and electrically coupled to the electrical socket (334) of the handle assembly (320). Once fully assembled, the aspiration instrument (310) is operable with the IGS navigation system (10) in the same manner as the aspiration instruments (110, 210) described above.
[0056] Although not shown, the handle assembly (320) and / or the detachable cannula assembly (350) of the suction instrument (310) may further include one or more resilient seals that function to prevent leakage of air, fluid, or debris from the junction between the suction lumen (364) and the suction passageway (326). Such seals may also function to prevent fluid from contacting and shorting the electrical contacts (334, 380). Additionally, the handle assembly (320) and / or the detachable cannula assembly (350) may further include one or more releasable locking mechanisms (e.g., latches, detents, magnets, etc.) that function to strengthen the mechanical connection between the handle assembly (320) and the detachable cannula assembly (350).
[0057] Although the handle assemblies (220, 320) of the suction instruments (210, 310) are shown and described herein in connection with the suction attachments (260, 350), it will be appreciated that the handle assemblies (220, 320) may be used interchangeably with various other types of surgical attachments having proximal ends suitably configured for releasable coupling with the handle assemblies (220, 320). By way of example only, such alternative attachments may incorporate, in whole or in part, any one or more of the devices disclosed below. Specifically, U.S. Patent Application Publication No. 2018 / 0085174, published on March 29, 2018, entitled "Suction Device for Use in Image-Guided Sinus Medical Procedure," U.S. Patent Application No. 62 / 658,688, filed on March 17, 2018, entitled "Curette with Navigation Sensor," U.S. Patent Application No. 15 / 795,473, filed on October 27, 2017, entitled "Tissue Shaving Instrument," U.S. Patent Application No. 15 / 830,205, filed on December 4, 2017, entitled "Dilation Instrument with Navigation and Distally Located Force Sensor," U.S. Patent Application No. 15 / 830,205, filed on December 12, 2017, entitled "Tissue Shaving Instrument with Navigation and Distally Located Force Sensor," and U.S. Patent Application No. 15 / 830,205, filed on December 4, 2017, entitled "Tissue Shaving Instrument with Navigation and Distally Located Force Sensor." U.S. patent application Ser. No. 15 / 839,274, filed December 22, 2017, entitled "Dilation Instrument with Guide Catheter Type Sensor," U.S. patent application Ser. No. 15 / 852,470, filed June 7, 2018, entitled "Endoscope with Integral Navigation Sensor," U.S. patent application Ser. No. 16 / 002,016, filed August 17, 2018, entitled "Endoscope with Anatomy Elevation Assembly," U.S. patent application Ser. No. 62 / 765, filed August 17, 2018, entitled "Endoscope with Anatomy Elevation Assembly,"No. 168, U.S. Patent Application No. 62 / 741,594, filed October 5, 2018, entitled "Hollow Tube Surgical Instrument with Single Axis Sensor," U.S. Patent Application No. 62 / 741,614, filed October 5, 2018, entitled "Dilation Instrument with Malleable Guide and Dilation Catheter with Integral Position Sensor," or U.S. Patent Application No. 62 / 741,778, filed October 5, 2018, entitled "Pointer Instrument with Malleable Shaft and Integral Position Sensor," the disclosures of which are incorporated herein by reference.
[0058] IV. Exemplary Combinations The following examples illustrate various, non-exhaustive, ways in which the teachings herein can be combined or applied. It is understood that the following examples are not intended to limit the scope of any claims that may be presented at any time in this application or in a later filing related to this application. No negative element is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be configured and applied in many other ways. It is also contemplated that certain features referred to in the following examples may be omitted in some variations. Accordingly, none of the aspects or features referred to below should be considered critical unless later expressly indicated to be so by the inventor or the inventor's successor in interest. If a claim including additional features other than those referred to below is presented in this application or in a later filing related to this application, those additional features should not be presumed to have been added for any reasons related to patentability. [Example]
[0059] 1. A surgical instrument comprising: (a) a proximal end; (b) a distal end configured to be positioned within or adjacent to an anatomical passageway of a patient; (c) an aspiration lumen extending between the proximal and distal ends, the aspiration lumen configured to provide suction at the distal end; (d) a navigation sensor disposed along a portion of the aspiration lumen, the navigation sensor operable to generate an electrical signal corresponding to a position of the portion within the patient; and (e) a coupling mechanism disposed at the proximal end, the coupling mechanism configured to releasably couple the proximal end to a body. [Example]
[0060] 10. The surgical instrument of claim 1, further comprising a suction tube, the suction tube defining a suction lumen. [Example]
[0061] 3. The surgical instrument of claim 1 or 2, wherein the navigation sensor is disposed at the distal end. [Example]
[0062] The surgical instrument of any one of Examples 1 to 3, wherein the navigation sensor comprises an electromagnetic sensor. [Example]
[0063] 5. The surgical instrument of example 4, wherein the electromagnetic sensor comprises a conductive coil. [Example]
[0064] The surgical instrument of any one of Examples 1 to 5, further comprising an electrical connector disposed at the proximal end, the electrical connector being electrically coupled to the navigation sensor. [Example]
[0065] 7. The surgical instrument of any one of Examples 1 to 6, further comprising an EEPROM, the EEPROM operable to store data relating to the suction instrument. [Example]
[0066] The surgical instrument of any one of Examples 1 to 7, further comprising a connector block disposed at the proximal end, the suction lumen extending distally relative to the connector block. [Example]
[0067] 9. The surgical instrument of Example 8, wherein the coupling mechanism comprises at least one of a protrusion or a recess provided by the connector block. [Example]
[0068] The surgical instrument of any one of Examples 1 to 9, wherein the coupling mechanism comprises a first coupling mechanism, and the suction instrument further comprises a body having a second coupling mechanism configured to releasably engage with the first coupling mechanism, thereby releasably coupling the suction lumen to the body. [Example]
[0069] 11. The surgical instrument of Example 10, wherein the body includes a passageway having a proximal end configured to be fluidly coupled to a suction source and a distal end configured to be fluidly coupled to the suction lumen when the first coupling mechanism engages with the second coupling mechanism. [Example]
[0070] A surgical instrument as described in Example 10 or 11, wherein the body includes a vent opening in fluid communication with the passage and the suction lumen, and the vent opening is configured to be selectively closed to transfer suction from the suction source to the suction lumen. [Example]
[0071] A surgical instrument described in any one of Examples 10 to 12, further comprising: (a) a first electrical connector disposed at the proximal end of the suction lumen, the first electrical connector being electrically coupled to the navigation sensor; and (b) a second electrical connector disposed at the distal end of the body, the second electrical connector being configured to communicate with the processor, wherein the first electrical connector and the second electrical connector are configured to be electrically coupled to each other when the suction lumen is coupled to the body, thereby transmitting an electrical signal from the navigation sensor to the processor. [Example]
[0072] The surgical instrument of any one of Examples 10 to 13, further comprising a connector block disposed at a proximal end of the suction lumen, the connector block providing the first coupling mechanism. [Example]
[0073] The surgical instrument of any one of Examples 10 to 14, further comprising: (a) a first EEPROM housed within the connector block, the first EEPROM operable to store data relating to at least one of the connector block or the suction lumen; and (b) a second EEPROM housed within the main body, the second EEPROM operable to store data relating to the main body. [Example]
[0074] 1. A surgical instrument comprising: (a) a body having (i) a proximal end configured to be coupled to a suction source and (ii) a distal end configured to be releasably coupled to an attachable member having a suction lumen, wherein the distal end of the attachable member is configured to be positioned within or adjacent to an anatomical passageway of a patient, the body being configured to be grasped by a user to manipulate the attachable member relative to the patient; (b) a passageway extending through the body, the passageway having (i) a proximal end configured to be fluidly coupled to a suction source and (ii) a distal end configured to be fluidly coupled to the suction lumen of the attachable member, the suction passageway being configured to transmit suction from the suction source to the suction lumen; and (c) a first electrical connector disposed at the distal end of the body, the first electrical connector configured to be releasably coupled to a second electrical connector of the attachable member and to receive an electrical signal corresponding to a position of the attachable member within the patient. [Example]
[0075] 17. The surgical instrument of Example 16, further comprising a first coupling mechanism disposed at a distal end of the body, the first coupling mechanism configured to releasably couple with a second coupling mechanism of the attachable member, the first coupling mechanism further configured to facilitate alignment of the first electrical connector and the second electrical connector during attachment of the attachable member to the body. [Example]
[0076] 18. The surgical instrument of claim 16 or 17, further comprising an EEPROM housed within the body, the EEPROM operable to store data related to the body. [Example]
[0077] 1. A surgical instrument comprising: (a) a body, the body having a first coupling mechanism; (b) a cannula assembly configured to extend distally from the body, the cannula assembly including: (i) a suction tube having an open distal end configured to provide suction within or adjacent to an anatomical passageway of a patient; (ii) a navigation sensor disposed along a portion of the suction tube, the navigation sensor operable to generate an electrical signal corresponding to a position of the portion within the patient; and (iii) a second coupling mechanism disposed at a proximal end of the suction tube, the second coupling mechanism configured to releasably engage with the first coupling mechanism to couple the suction tube with the body. [Example]
[0078] A surgical instrument as described in Example 19, wherein the body includes a first electrical connector configured to be electrically coupled to the processor, and the cannula assembly includes a second electrical connector electrically coupled to the navigation sensor, and the first electrical connector and the second electrical connector are releasably coupled to each other and configured to transmit electrical signals from the navigation sensor to the processor.
[0079] V. Other It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Accordingly, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from one another. Various suitable ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
[0080] Any patent, publication, or other disclosure referred to herein as being incorporated by reference should be understood to be incorporated herein, in whole or in part, only to the extent that the incorporated content does not contradict current definitions, views, or other disclosures set forth in this disclosure. As such, and to the extent necessary, the disclosures explicitly set forth herein shall prevail over any conflicting statements incorporated herein by reference. Any content, or portions thereof, that is referred to herein as being incorporated by reference but that contradicts current definitions, views, or other disclosures set forth herein shall be incorporated only to the extent that no conflict arises between the incorporated content and the current disclosures.
[0081] Device variations disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, the variations can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, device variations can be disassembled, and any number of particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, the device variation can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present invention.
[0082] By way of example only, the variations described herein can be processed prior to surgery. First, new or used instruments can be obtained and, if necessary, cleaned. In some cases, the instruments can be placed in a reprocessing tray (e.g., a metal bin or basket) and then cleaned in a surgical instrument washer. 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 instruments can then be placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the instruments and in the container. The sterilized instruments can then be stored in the sterile container. The sealed container can keep the instruments sterile until opened at the surgical facility. Devices can also be sterilized using any other technique known in the art, including, but not limited to, beta or gamma radiation, ethylene oxide, water vapor, hydrogen peroxide vapor (e.g., with the STERRAD sterilization system by Advanced Sterilization Products, Inc., Irvine, California), and / or using any other suitable system or technique.
[0083] While various variations of the present invention have been shown and described, further applications of the methods and systems described herein may be realized by those skilled in the art through appropriate modifications without departing from the scope of the present invention. While some of such possible modifications have been described, other modifications will be apparent to those skilled in the art. For example, the above-described embodiments, variations, geometries, materials, dimensions, proportions, steps, etc. are illustrative and not required. Accordingly, the scope of the present invention should be considered in light of the following claims and should not be understood to be limited to the details of structure and operation shown and described in this specification and drawings.
[0084] [Embodiment] (1) A suction device, (a) a proximal end; (b) a distal end configured to be placed within or adjacent to an anatomical passageway of a patient; (c) a suction lumen extending between the proximal end and the distal end, the suction lumen configured to provide suction at the distal end; (d) a navigation sensor disposed along a portion of the aspiration lumen, the navigation sensor operable to generate an electrical signal corresponding to a position of the portion within the patient; (e) a coupling mechanism disposed at the proximal end, the coupling mechanism configured to releasably couple the proximal end to a body. (2) The suction device of embodiment 1, further comprising a suction tube, the suction tube defining the suction lumen. (3) A suction instrument as described in embodiment 1, wherein the navigation sensor is disposed at the distal end. (4) The suction device of embodiment 1, wherein the navigation sensor includes an electromagnetic sensor. (5) The suction instrument of claim 4, wherein the electromagnetic sensor comprises a conductive coil.
[0085] (6) The suction instrument of embodiment 1, further comprising an electrical connector disposed at the proximal end, the electrical connector being electrically coupled to the navigation sensor. (7) The suction device of embodiment 1, further comprising an EEPROM, the EEPROM operable to store data relating to the suction device. (8) The suction instrument of embodiment 1, further comprising a connector block disposed at the proximal end, wherein the suction lumen extends distally relative to the connector block. (9) The suction instrument of embodiment 8, wherein the coupling mechanism comprises at least one of a protrusion or a recess provided by the connector block. (10) The suction instrument of embodiment 1, wherein the coupling mechanism comprises a first coupling mechanism, and the suction instrument further comprises a body having a second coupling mechanism configured to releasably engage with the first coupling mechanism, thereby releasably coupling the suction lumen to the body.
[0086] (11) The suction instrument of embodiment 10, wherein the body includes a passageway having a proximal end configured for fluid communication with a suction source and a distal end configured for fluid communication with the suction lumen when the first coupling mechanism engages with the second coupling mechanism. (12) The suction device of embodiment 10, wherein the body includes a vent opening in fluid communication with the passage and the suction lumen, the vent opening configured to be selectively closed to transmit suction from the suction source to the suction lumen. (13) (a) a first electrical connector disposed at a proximal end of the aspiration lumen, the first electrical connector being electrically coupled to the navigation sensor; (b) a second electrical connector disposed at the distal end of the body, the second electrical connector configured to communicate with a processor; An suction device as described in embodiment 10, wherein the first electrical connector and the second electrical connector are configured to electrically connect to each other when the suction lumen is connected to the body, thereby transmitting the electrical signal from the navigation sensor to the processor. (14) The suction instrument of embodiment 10, further comprising a connector block disposed at a proximal end of the suction lumen, the connector block providing the first coupling mechanism. (15) (a) a first EEPROM housed within the connector block, the first EEPROM operable to store data relating to at least one of the connector block or the aspiration lumen; (b) a second EEPROM housed within the main body, the second EEPROM operable to store data relating to the main body.
[0087] (16) A suction device, (a) a body, (i) a proximal end configured to couple to a suction source; (ii) a distal end configured to be releasably coupled to an attachable member having an aspiration lumen, the distal end of the attachable member configured to be positioned within or adjacent to an anatomical passageway of a patient; a body configured to be grasped by a user to manipulate the attachable member relative to the patient; and (b) a passageway extending through the body, (i) a proximal end configured to be fluidly coupled to the suction source; (ii) a distal end configured to be fluidly coupled with the suction lumen of the attachable member; a passageway, the suction passageway configured to transmit suction from the suction source to the suction lumen; (c) a first electrical connector disposed at the distal end of the body, the first electrical connector configured to releasably couple with a second electrical connector of the attachable member and to receive an electrical signal corresponding to a position of the attachable member within the patient. (17) The suction instrument of embodiment 16, further comprising a first coupling mechanism disposed at the distal end of the body, the first coupling mechanism configured to be releasably coupled to a second coupling mechanism of the attachable member, and the first coupling mechanism further configured to facilitate alignment of the first electrical connector and the second electrical connector during attachment of the attachable member to the body. (18) The suction instrument of embodiment 16, further comprising an EEPROM housed within the main body, the EEPROM operable to store data related to the main body. (19) A suction device, (a) a main body, the main body having a first coupling mechanism; (b) a cannula assembly configured to extend distally from the body, (i) a suction tube having an open distal end configured to provide suction within or adjacent to an anatomical passageway of a patient; (ii) a navigation sensor disposed along a portion of the aspiration tube, the navigation sensor operable to generate an electrical signal corresponding to a position of the portion within the patient; (iii) a second coupling mechanism disposed at a proximal end of the suction tube, the second coupling mechanism configured to releasably engage with the first coupling mechanism to couple the suction tube to the body. (20) The suction device of embodiment 19, wherein the body includes a first electrical connector configured to electrically couple to a processor, the cannula assembly includes a second electrical connector electrically coupled to the navigation sensor, and the first electrical connector and the second electrical connector are releasably coupled to each other and configured to transmit the electrical signal from the navigation sensor to the processor.
Claims
1. 1. A suction attachment for a suction device, comprising: (a) a proximal end; (b) a distal end configured to be positioned within or adjacent to an anatomical passageway of a patient; (c) a suction lumen extending between the proximal end and the distal end, the suction lumen configured to provide suction at the distal end; (d) a navigation sensor disposed along a portion of the aspiration lumen, the navigation sensor operable to generate an electrical signal corresponding to a position of the portion within the patient; (e) a first coupling mechanism disposed on the proximal end, the first coupling mechanism configured to releasably couple the proximal end to a body of a handle assembly, the body having a second coupling mechanism configured to releasably couple the aspiration lumen to the body by releasably engaging the first coupling mechanism; and (f) a first electrical connector disposed at a proximal end of the aspiration lumen, the first electrical connector electrically coupled to the navigation sensor, the first electrical connector configured to electrically couple with a second electrical connector, the second electrical connector disposed at a distal end of the body and configured to communicate with the processor when the aspiration lumen is coupled to the body to transmit the electrical signal from the navigation sensor to the processor; (g) a connector block disposed at the proximal end, the suction lumen extending distally relative to the connector block; A suction attachment, wherein the first coupling mechanism comprises a pair of arms provided by the connector block, the pair of arms being configured to be received in a pair of recessed grooves provided in the body of the handle assembly, thereby releasably coupling the proximal end to the body of the handle assembly.
2. A suction attachment for a suction instrument, comprising: (a) a proximal end; (b) a distal end configured to be positioned within or adjacent to an anatomical passageway of a patient; (c) a suction lumen extending between the proximal end and the distal end, the suction lumen configured to provide suction at the distal end; (d) a navigation sensor disposed along a portion of the aspiration lumen, the navigation sensor operable to generate an electrical signal corresponding to a position of the portion within the patient; (e) a first coupling mechanism disposed on the proximal end, the first coupling mechanism configured to releasably couple the proximal end to a body of a handle assembly, the body having a second coupling mechanism configured to releasably couple the aspiration lumen to the body by releasably engaging the first coupling mechanism; and (f) a first electrical connector disposed at a proximal end of the aspiration lumen, the first electrical connector electrically coupled to the navigation sensor, the first electrical connector configured to electrically couple with a second electrical connector, the second electrical connector disposed at a distal end of the body and configured to communicate with the processor when the aspiration lumen is coupled to the body to transmit the electrical signal from the navigation sensor to the processor; (g) a connector block disposed at the proximal end, the suction lumen extending distally relative to the connector block; A suction attachment, wherein the first coupling mechanism comprises a pair of recessed grooves provided by the connector block, the pair of recessed grooves being configured to receive a pair of arms provided on the body of the handle assembly, thereby releasably coupling the proximal end to the body of the handle assembly.
3. 3. The suction attachment of claim 1 or 2, further comprising a suction tube, said suction tube defining said suction lumen.
4. 3. A suction attachment according to claim 1 or 2, wherein the navigation sensor is disposed at the distal end.
5. 3. A suction attachment according to claim 1 or 2, wherein the navigation sensor comprises an electromagnetic sensor.
6. The suction attachment of claim 5 , wherein the electromagnetic sensor comprises a conductive coil.
7. 3. A suction attachment according to claim 1 or 2, further comprising an EEPROM, said EEPROM operable to store data relating to said suction apparatus.
8. (a) a first EEPROM housed within the connector block, the first EEPROM operable to store data relating to at least one of the connector block or the aspiration lumen; 3. A suction attachment according to claim 1 or 2, further comprising: (b) a second EEPROM housed within the body, the second EEPROM operable to store data relating to the body.
9. 1. A handle assembly for a suction instrument, comprising: (a) a body, (i) a proximal end configured to couple to a suction source; (ii) a distal end configured to be releasably coupled to a suction attachment having a suction lumen; a body configured to be grasped by a user to manipulate the suction attachment with respect to the patient, the suction attachment having a distal end configured to be positioned within or adjacent to an anatomical passageway of the patient; and (b) a passageway extending through the body, (i) a proximal end configured to be fluidly coupled to the suction source; (ii) a distal end configured to be fluidly coupled with the suction lumen of the suction attachment; a passageway configured to transmit suction from the suction source to the suction lumen; and (c) a first electrical connector disposed at the distal end of the body, the first electrical connector configured to releasably couple with a second electrical connector of the suction attachment to receive an electrical signal corresponding to a position of the suction attachment within the patient; and (d) a first coupling mechanism disposed at the distal end of the body, the first coupling mechanism configured to releasably couple with a second coupling mechanism of the suction attachment, the first coupling mechanism further configured to facilitate alignment of the first electrical connector and the second electrical connector during attachment of the suction attachment to the body; A handle assembly, wherein the first coupling mechanism has a pair of recessed grooves configured to receive a pair of arms provided on the second coupling mechanism, thereby releasably coupling the main body to the suction attachment.
10. A handle assembly for a suction instrument, comprising: (a) a body, (i) a proximal end configured to couple to a suction source; (ii) a distal end configured to be releasably coupled to a suction attachment having a suction lumen; a body configured to be grasped by a user to manipulate the suction attachment with respect to the patient, the suction attachment having a distal end configured to be positioned within or adjacent to an anatomical passageway of the patient; and (b) a passageway extending through the body, (i) a proximal end configured to be fluidly coupled to the suction source; (ii) a distal end configured to be fluidly coupled with the suction lumen of the suction attachment; a passageway configured to transmit suction from the suction source to the suction lumen; and (c) a first electrical connector disposed at the distal end of the body, the first electrical connector configured to releasably couple with a second electrical connector of the suction attachment to receive an electrical signal corresponding to a position of the suction attachment within the patient; and (d) a first coupling mechanism disposed at the distal end of the body, the first coupling mechanism configured to releasably couple with a second coupling mechanism of the suction attachment, the first coupling mechanism further configured to facilitate alignment of the first electrical connector and the second electrical connector during attachment of the suction attachment to the body; A handle assembly, wherein the first coupling mechanism has a pair of arms configured to be received in a pair of recessed grooves in the second coupling mechanism, thereby releasably coupling the main body to the suction attachment.
11. 11. A handle assembly according to claim 9 or 10, further comprising an EEPROM housed within the body, the EEPROM operable to store data relating to the body.
12. A handle assembly as described in claim 9 or 10, wherein the main body includes a vent opening fluidly connected to the passage and the suction lumen, the vent opening configured to be selectively closed to transfer suction from the suction source to the suction lumen.
13. A suction device comprising: (a) a handle assembly including a body, the body having a first coupling mechanism; (b) a suction attachment configured to extend distally from the body, (i) a suction tube having an open distal end configured to provide suction within or adjacent to an anatomical passageway of a patient; (ii) a navigation sensor disposed along a portion of the aspiration tube, the navigation sensor operable to generate an electrical signal corresponding to a position of the portion within the patient; (iii) a second coupling mechanism disposed at a proximal end of the suction tube, the second coupling mechanism configured to releasably engage the first coupling mechanism to couple the suction tube to the body; the body is configured to be grasped by a user to operate the suction attachment on the patient; the body includes a first electrical connector configured to electrically couple to a processor, the suction attachment includes a second electrical connector electrically coupled to the navigation sensor, the first electrical connector and the second electrical connector being releasably coupled to one another and configured to transmit the electrical signal from the navigation sensor to the processor; A suction instrument, wherein the first coupling mechanism includes a pair of recessed grooves configured to receive a pair of arms provided on the second coupling mechanism, thereby releasably coupling the body of the handle assembly to the suction attachment.
14. A suction device, comprising: (a) a handle assembly including a body, the body having a first coupling mechanism; (b) a suction attachment configured to extend distally from the body, (i) a suction tube having an open distal end configured to provide suction within or adjacent to an anatomical passageway of a patient; (ii) a navigation sensor disposed along a portion of the aspiration tube, the navigation sensor operable to generate an electrical signal corresponding to a position of the portion within the patient; (iii) a second coupling mechanism disposed at a proximal end of the suction tube, the second coupling mechanism configured to releasably engage the first coupling mechanism to couple the suction tube to the body; the body is configured to be grasped by a user to operate the suction attachment on the patient; the body includes a first electrical connector configured to electrically couple to a processor, the suction attachment includes a second electrical connector electrically coupled to the navigation sensor, the first electrical connector and the second electrical connector being releasably coupled to one another and configured to transmit the electrical signal from the navigation sensor to the processor; a suction instrument, wherein the first coupling mechanism includes a pair of arms configured to be received in a pair of recessed grooves in the second coupling mechanism, thereby releasably coupling the body of the handle assembly to the suction attachment.
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