Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/24—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
  • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
  • A61B5/062—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
  • A61B90/14—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
  • A61B2034/2046—Tracking techniques
  • A61B2034/2051—Electromagnetic tracking systems
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
  • A61B2218/007—Aspiration
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2505/00—Evaluating, monitoring or diagnosing in the context of a particular type of medical care
  • A61B2505/05—Surgical care
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0033—Features or image-related aspects of imaging apparatus classified in A61B5/00, e.g. for MRI, optical tomography or impedance tomography apparatus; arrangements of imaging apparatus in a room
  • A61B5/004—Features or image-related aspects of imaging apparatus classified in A61B5/00, e.g. for MRI, optical tomography or impedance tomography apparatus; arrangements of imaging apparatus in a room adapted for image acquisition of a particular organ or body part
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
  • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
  • A61B5/066—Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/71—Suction drainage systems
  • A61M1/74—Suction control
  • A61M1/741—Suction control with means for varying suction manually
  • A61M1/7411—Suction control with means for varying suction manually by changing the size of a vent

Definitions

• anatomical passageway of a patient such as performing an incision of mucosa, removal of bone, or dilation of an anatomical passageway.
• Such operations may occur within anatomical passageways such as ostia of paranasal sinuses (e.g., to treat sinusitis), the larynx, the Eustachian tube, or other passageways within the ear, nose, or throat, etc.
• suction and/or irrigation within or adjacent to an anatomical passageway before, during, or after the above described operations, or similar operations.
• One method of applying suction within or adjacent to an anatomical passageway of a patient involves obtaining a suction device having an elongate shaft defining a lumen terminating at an open distal end of the elongated shaft, where the lumen is in fluid communication with an external suction source. An operator may then insert the distal end of the elongate shaft within the nostril or mouth of a patient toward a desired location within the patient. With the distal end of the elongate shaft inserted within the patient, an operator may manipulate the suction device and/or suction source in order to remove extraneous and/or undesired matter near or within an anatomical passageway of a patient. Applying suction and/or irrigation during an operation may be beneficial for multiple purposes as will be apparent to those skilled in the art.
• Image-guided surgery is a technique where a computer is used to obtain a real-time correlation of the location of an instrument that has been inserted into a patient's body to a set of preoperatively obtained images (e.g., a CT or MRI scan, 3-D map, etc.) so as to superimpose the current location of the instrument on the preoperatively obtained images.
• a digital tomographic scan e.g., CT or MRI, 3-D map, etc.
• a specially programmed computer is then used to convert the digital tomographic scan data into a digital map.
• special instruments having sensors (e.g., electromagnetic coils that emit electromagnetic fields and/or are responsive to externally generated electromagnetic fields) mounted thereon are used to perform the procedure while the sensors send data to the computer indicating the current position of each surgical instrument.
• the computer correlates the data it receives from the instrument-mounted sensors with the digital map that was created from the preoperative tomographic scan.
• the tomographic scan images are displayed on a video monitor along with an indicator (e.g., cross hairs or an illuminated dot, etc.) showing the real time position of each surgical instrument relative to the anatomical structures shown in the scan images.
• an indicator e.g., cross hairs or an illuminated dot, etc.
• Examples of electromagnetic IGS systems that may be used in ENT and sinus surgery include the InstaTrak ENTTM systems available from GE Medical Systems, Salt Lake City, Utah.
• Other examples of electromagnetic image guidance systems that may be modified for use in accordance with the present disclosure include but are not limited to the CARTO® 3 System by Biosense-Webster, Inc., of Diamond Bar, California; systems available from Surgical Navigation Technologies, Inc., of Louisville, Colorado; and systems available from Calypso Medical Technologies, Inc., of Seattle, Washington.
• image guidance systems When applied to functional endoscopic sinus surgery (FESS), balloon sinuplasty, and/or other ENT procedures, the use of image guidance systems allows the surgeon to achieve more precise movement and positioning of the surgical instruments than can be achieved by viewing through an endoscope alone. This is so because a typical endoscopic image is a spatially limited, 2 dimensional, line-of-sight view.
• image guidance systems provides a real time, 3 -dimensional view of all of the anatomy surrounding the operative field, not just that which is actually visible in the spatially limited, 2 dimensional, direct line-of-sight endoscopic view.
• image guidance systems may be particularly useful during performance of FESS, balloon sinuplasty, and/or other ENT procedures where a section and/or irrigation source may be desirable, especially in cases where normal anatomical landmarks are not present or are difficult to visualize endoscopically.
• FIG. 1 depicts a schematic view of an exemplary sinus surgery navigation system
• FIG. 2 depicts a perspective view of the head of a patient, with components of the navigation system of FIG. 1;
• FIG. 3 depicts a perspective view of an exemplary suction instrument
• FIG. 4 depicts a cross-sectional side view of the suction instrument of FIG. 3, taken along line 4-4 of FIG. 3;
• FIG. 5 depicts a perspective view of the suction instrument of FIG. 3, with an adapter to receive a navigation guidewire;
• FIG. 6 depicts a perspective view of another exemplary suction instrument, with an integral navigation guidewire port
• FIG. 7 depicts a top plan view of a grip portion of the suction instrument of FIG. 6;
• FIG. 8 depicts a bottom plan view of the grip portion of FIG. 7;
• FIG. 9 depicts a side elevational view of the grip portion of FIG. 7;
• FIG. 10 depicts a cross-sectional side view of the grip portion of FIG. 7, taken along line 10-10 of FIG. 7;
• FIG. 11 depicts a perspective view of another exemplary suction instrument, with an integral navigation guidewire port and guidewire locking feature
• FIG. 12 depicts a top plan view of a proximal portion of the suction instrument of
• FIG. 11 is a diagrammatic representation of FIG. 11
• FIG. 13 depicts a perspective view of the proximal portion of FIG. 12;
• FIG. 14 depicts a cross-sectional top view of the proximal portion of FIG. 12, taken along line 14-14 of FIG. 15;
• FIG. 15 depicts a cross-sectional side view of the proximal portion of FIG. 12, taken along line 15-15 of FIG. 12;
• FIG. 16A depicts a cross-sectional top view of the proximal portion of FIG. 12, taken along line 14-14 of FIG. 15, with a navigation guidewire disposed therein, and with the locking feature in a locked state;
• FIG. 16B depicts a cross-sectional top view of the proximal portion of FIG. 12, taken along line 14-14 of FIG. 15, with a navigation guidewire disposed therein, and with the locking feature in an unlocked state;
• FIG. 17 depicts a perspective view of another exemplary suction instrument, with an integral navigation guidewire port and guidewire locking feature
• FIG. 18 depicts a top plan view of a grip portion of the suction instrument of FIG.
• FIG. 19 depicts a side elevational view of the grip portion of FIG. 18;
• FIG. 20A depicts a cross-sectional perspective view of the grip portion of FIG. 18, taken along line 20-20 of FIG. 19, with the locking feature in a locked state;
• FIG. 20B depicts a cross-sectional perspective view of the grip portion of FIG. 18, taken along line 20-20 of FIG. 19, with the locking feature in an unlocked state;
• FIG. 21 depicts a perspective view of another exemplary suction instrument, with an integral navigation guidewire port and guidewire locking feature
• FIG. 22 depicts a top plan view of a grip portion of the suction instrument of FIG.
• FIG. 23 depicts a side elevational view of the grip portion of FIG. 22;
• FIG. 24 depicts a cross-sectional side view of the grip portion of FIG. 22, taken along line 24-24 of FIG. 22;
• FIG. 25 A depicts a cross-sectional side view of the grip portion of FIG. 22, taken along line 24-24 of FIG. 22, with a navigation guidewire disposed therein, and with the locking feature in a locked state;
• FIG. 25B depicts a cross-sectional side view of the grip portion of FIG. 22, taken along line 24-24 of FIG. 22, with a navigation guidewire disposed therein, and with the locking feature in an unlocked state;
• FIG. 26 depicts a perspective view of another exemplary suction instrument, with an integral navigation guidewire port and guidewire locking feature
• FIG. 27 depicts a top plan view of a grip portion of the suction instrument of FIG.
• FIG. 28 depicts a perspective view of the grip portion of FIG. 27;
• FIG. 29 depicts a cross-sectional top view of the grip portion of FIG. 27, taken along line 29-29 of FIG. 30;
• FIG. 30 depicts a cross-sectional side view of the grip portion of FIG. 27, taken along line 30-30 of FIG. 27;
• FIG. 31A depicts a cross-sectional top view of the grip portion of FIG. 27, taken along line 29-29 of FIG. 30, with a navigation guidewire disposed therein, and with the locking feature in a locked position;
• FIG. 3 IB depicts a cross-sectional top view of the grip portion of FIG. 27, taken along line 29-29 of FIG. 30, with a navigation guidewire disposed therein, and with the locking feature in an unlocked position.
• top and bottom also are used herein with respect to the clinician gripping the handpiece assembly.
• surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
• FIG. 1 shows an exemplary IGS navigation system (1) whereby an ENT procedure may be performed using IGS.
• IGS navigation system (1) is used during a procedure where suction adjacent to and/or within the procedure site is desired.
• IGS navigation system (1) may be readily used in various other kinds of procedures.
• IGS navigation system (1) may be constructed and operable in accordance with at least some of the teachings of U.S. Pat. No. 8,702,626, entitled “Guidewires for Performing Image Guided Procedures,” issued April 22, 2014, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,320,711, entitled “Anatomical Modeling from a 3-D Image and a Surface Mapping,” issued November 27, 2012, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 8,190,389, entitled “Adapter for Attaching Electromagnetic Image Guidance Components to a Medical Device,” issued May 29, 2012, the disclosure of which is incorporated by reference herein; U.S. Pat. No.
• IGS navigation system (1) may be constructed and operable in accordance with at least some of the teachings of U.S. Pat. Pub. 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 by reference herein; U.S. Pat. Pub. No. 2014/0200444, entitled “Guidewires for Performing Image Guided Procedures,” published July 17, 2014, the disclosure of which is incorporated by reference herein; U.S. Pat. No.
• IGS navigation system (1) of the present example comprises a set of magnetic field generators (22).
• field generators (22) are fixed to the head of the patient.
• field generators (22) are incorporated into a frame (20), which is clamped to the head of the patient. While field generators (22) are secured to the head of the patient in this example, it should be understood that field generators (22) may instead be positioned at various other suitable locations and on various other suitable structures.
• field generators (22) may be mounted on an independent structure that is fixed to a table or chair on which the patient is positioned, on a floor-mounted stand that has been locked in position relative to the head of the patient, and/or at any other suitable location(s) and/or on any other suitable structure(s).
• Field generators (22) are operable to generate an electromagnetic field around the head of the patient.
• field generators (22) are operated so as to transmit alternating magnetic fields of different frequencies into a region in proximity to frame (20).
• Field generators (22) thereby enable tracking of the position of a navigation guidewire (30) that is inserted into a nasal sinus of the patient and in other locations within the patient's head.
• Various suitable components that may be used to form and drive field generators (22) will be apparent to those of ordinary skill in the art in view of the teachings herein.
• IGS navigation system (1) of the present example further comprises a processor
• Processor (10) which controls field generators (22) and other elements of IGS navigation system (1).
• Processor (10) comprises a processing unit communicating with one or more memories.
• Processor (10) of the present example is mounted in a console (16), which comprises operating controls (12) that include a keypad and/or a pointing device such as a mouse or trackball.
• a physician uses operating controls (12) to interact with processor (10) while performing the surgical procedure.
• Console (16) also connects to other elements of system (1).
• a coupling unit (32) is secured to the proximal end of navigation guidewire (30).
• Coupling unit (32) of this example is configured to provide wireless communication of data and other signals between console (16) and navigation guidewire (30).
• coupling unit (32) simply communicates data or other signals from navigation guidewire (30) to console (16) uni-directionally, without also communicating data or other signals from console (16).
• coupling unit (32) provides bidirectional communication of data or other signals between navigation guidewire (30) to console (16).
• coupling unit (32) of the present example couples with console (16) wirelessly, some other versions may provide wired coupling between coupling unit (32) and console (16).
• Various other suitable features and functionality that may be incorporated into coupling unit (32) will be apparent to those of ordinary skill in the art in view of the teachings herein.
• Processor (10) uses software stored in a memory of processor (10) to calibrate and operate system (1). Such operation includes driving field generators (22), processing data from navigational guidewire (30), processing data from operating controls (12), and driving display screen (14).
• the software may be downloaded to processor (10) in electronic form, over a network, for example, or it may, alternatively or additionally, be provided and/or stored on non-transitory tangible media, such as magnetic, optical, or electronic memory.
• Processor (10) is further operable to provide video in real time via display screen (14), showing the position of the distal end of navigational guidewire (30) in relation to a video camera image of the patient's head, a CT scan image of the patient's head, and/or a computer generated three-dimensional model of the anatomy within and adjacent to the patient's nasal cavity.
• Display screen (14) may display such images simultaneously and/or superimposed on each other.
• display screen (14) may display such images during the surgical procedure.
• Such displayed images may also include graphical representations of instruments that are inserted in the patient's head, such as navigational guidewire (30), such that the operator may view the virtual rendering of the instrument at its actual location in real time.
• display screen (14) may provide images in accordance with at least some of the teachings of U.S. Pub. No. 2016/0008083, entitled “Guidewire Navigation for Sinuplasty,” published January 14, 2016, the disclosure of which is incorporated by reference herein.
• the endoscopic image may also be provided on display screen (14). The images provided through display screen (14) may help guide the operator in maneuvering and otherwise manipulating instruments within the patient's head.
• navigational guidewire (30) includes one or more coils at the distal end of navigational guidewire (30).
• a coil When such a coil is positioned within an electromagnetic field generated by field generators (22), movement of the coil within that magnetic field may generate electrical current in the coil, and this electrical current may be communicated along the electrical conduit(s) in navigational guidewire (30) and further to processor (10) via coupling unit (32).
• This phenomenon may enable IGS navigation system (1) to determine the location of the distal end of navigational guidewire (30) within a three-dimensional space as will be described in greater detail below.
• processor (10) executes an algorithm to calculate location coordinates of the distal end of navigational guidewire (30) from the position related signals of the coil(s) in navigational guidewire (30). While a coil is incorporated into navigational guidewire (30) to provide a navigational sensor in the present example, it should be understood that any other suitable components may be incorporated into navigational guidewire (30) to provide a navigational sensor.
• navigational guidewire (30) is used to generate a three- dimensional model of the anatomy within and adjacent to the patient's nasal cavity; in addition to being used to provide navigation for dilation catheter system (1) within the patient's nasal cavity.
• any other suitable device may be used to generate a three-dimensional model of the anatomy within and adjacent to the patient's nasal cavity before navigational guidewire (30) is used to provide navigation for dilation catheter system (1) within the patient's nasal cavity.
• a model of this anatomy may be generated in accordance with at least some of the teachings of U.S. Pub. No. 2016/0310042, entitled “System and Method to Map Structures of Nasal Cavity," published October 27, 2016, the disclosure of which is incorporated by reference herein.
• Console (16) may thus render images of at least a portion of the model via display screen (14) and further render real-time video images of the position of navigational guidewire (30) in relation to the model via display screen (14).
• FIGS. 3-4 show an exemplary suction instrument assembly (50) that may be used to provide suction in such procedures.
• instrument assembly (50) includes a suction instrument (60) that is fluidly coupled with a suction source (80) via a conduit (90).
• Suction source (80) may comprise a vacuum pump and a fluid reservoir, among other components, as is known in the art.
• Suction source (80) is configured to provide enough suction to pull excess fluid and/or debris through suction instrument (60).
• Suction instrument (60) of this example comprises an elongate cannula (62) extending distally from a grip portion (70).
• Cannula (62) has an open distal end (64) and a bent region (66) formed just distal to grip portion (70).
• Bent region (66) defines a bend angle that is selected to facilitate insertion of distal end (64) in a patient by an operator grasping grip portion (70).
• Various suitable bend angles that may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
• cannula (62) is rigid such that cannula (62) maintains the bend of bent region (66) and does not buckle during insertion into a patient's nasal cavity.
• cannula (62) may be formed of stainless steel (e.g., a stainless steel hypotube, etc.) and/or any other suitable rigid material.
• cannula (62) defines a lumen (68) with a diameter of approximately 2.44 mm. Alternatively, any other suitable diameter may be used.
• lumen (68) may have an elliptical cross-sectional profile or some other non-circular cross- sectional profile, if desired. A non-circular cross-sectional profile may provide additional clearance for other instruments to be positioned simultaneously in the same anatomical passageway (e.g., nasal cavity) with cannula (62).
• Grip portion (70) of the present example includes a proximal suction conduit port
• port (72) that is configured to couple with conduit (90).
• port (72) has a barbed configuration to promote a secure fit with an elastomeric conduit (90), though it should be understood that various other kinds of configurations may be used for port (72).
• Grip portion (70) of the present example further includes a transverse vent opening (74) formed through an upper surface (75); and a lower surface (76).
• vent opening (74) is in fluid communication with a lumen (78) formed through grip portion (70).
• Vent opening (74) has a teardrop shape in the present example, though it should be understood that vent opening (74) may have any other suitable shape.
• the teardrop shape (or some other elongate shape) may enable the operator to selectively vary the amount of suction based on the longitudinal position of the operator's thumb (or other finger) on vent opening (74).
• Lumen (78) is further in fluid communication with port (72) and a lumen (68) of cannula (62). It should be understood that lumens (68, 78) cooperate to provide an unobstructed fluid path from port (72) to open distal end (64) of cannula (62).
• Surfaces (75, 76) are configured to promote gripping of grip portion (70) by an operator.
• upper surface (75) provides a concave contour while lower surface (76) provides a series of ridges.
• an operator may grasp grip portion (70) by placing a thumb on upper surface (75) and the side of the index finger of the same hand on lower surface (76).
• the rectangular shape of grip portion (70) may provide the operator with substantial purchase on grip portion (70), while the configurations of surfaces (75, 76) may further secure the operator's grip.
• suction source (80) remains in a constantly activated state.
• the operator may leave vent opening (74) uncovered as the operator positions instrument (60) relative to the patient. This may result in suction source (80) drawing suction through vent opening (74) without drawing suction through open distal end (64).
• the operator may simply cover vent opening (74) with the operator' s thumb (or otherwise cover vent opening (74)). The operator may thus selectively cover and uncover vent opening during a procedure in order to selectively apply suction.
• suction instruments While the above and below examples are provided in the context of suction instruments, it should be understood that the same instruments (and variations thereof) may be used to provide fluid irrigation at a target site in a patient; or to provide various other kinds of functionality.
• the teachings herein are thus not limited to suction instruments and operations per se.
• Other suitable instruments and procedures in which the teachings herein may be applied will be apparent to those of ordinary skill in the art.
• FIG. 5 shows an exemplary modified suction instrument assembly (100) where instrument (60) has been modified to include an adapter (110).
• Adapter (110) of this example has a "Y" shape formed by an outlet (112), a first inlet (114), and a second inlet (116).
• Outlet (1 12) is coupled with conduit port (72) of grip portion (70). It should be understood that outlet (112) may be removably secured to conduit port (72), such that an operator may readily couple adapter (110) with grip portion (70) and decouple adapter (110) from grip portion (70) as desired.
• Outlet (112) defines an outlet lumen (122) that is in fluid communication with lumen (78) of grip portion (70).
• First inlet (114) defines a first inlet lumen (124), which is in communication with outlet lumen (122).
• a navigation guidewire (130) is slidably disposed in first inlet lumen (124).
• Navigation guidewire (130) continues through outlet lumen (122), through lumen (78) of grip portion (70), and further through lumen (68) of cannula (62), such that the distal end of navigation guidewire (130) protrudes distally from distal end (64) of cannula (62).
• the proximal end of guidewire (130) is coupled with console (16). It should be understood that guidewire (130) of this example is configured and operable just like guidewire (30) described above.
• an operator may use IGS navigation system (1) to determine the location of the distal end of guidewire (130) within a patient, to thereby determine the location of distal end (64) of cannula (62) in the patient. Moreover, the operator may freely slide guidewire (130) within lumens (68, 78, 122, 124), to thereby facilitate probing with the distal end of guidewire (130).
• Second inlet (116) defines a second inlet lumen (126), which is also in communication with outlet lumen (122).
• Conduit (90) is coupled with second inlet (116).
• Conduit (90) is also coupled with suction source (80).
• Conduit (90) thus provides a path for suction from suction source (80) to second inlet lumen (126).
• the suction from suction source (80) is further communicated to distal end (64) of cannula (62) via lumens (68, 78, 122, 126).
• lumens (68, 78, 122) provide a path for communication of suction and guidewire (130).
• the diameters of lumens (68, 78, 122) are large enough to enable an effective amount of suction to reach distal end (64) even while guidewire (130) is disposed in lumens (68, 78, 122).
• first inlet (114) further includes a seal.
• a seal may substantially prevent atmospheric air from being drawn in through first inlet lumen (124) while suction source (80) is being activated; while still permitting guidewire (130) to slide substantially freely through first inlet lumen (124).
• the seal provides friction against guidewire (130), such that the seal substantially prevents inadvertent translation of guidewire (130) through inlet lumen (124) while still permitting intended translation of guidewire (130) through inlet lumen (124).
• a seal may substantially prevent atmospheric air from being drawn in through first inlet lumen (124) while suction source (80) is being activated; while still permitting guidewire (130) to slide substantially freely through first inlet lumen (124).
• the seal provides friction against guidewire (130), such that the seal substantially prevents inadvertent translation of guidewire (130) through inlet lumen (124) while still permitting intended translation of guidewire (130) through inlet lumen (124).
• FIG. 6 shows an exemplary suction instrument assembly (200) that includes a suction instrument (210) having an integral navigation guidewire port (222).
• Suction instrument assembly (200) of this example further includes console (16), navigation guidewire (130), suction source (80), and conduit (90), each of which is described above.
• Suction instrument (210) of the present example includes an elongate cannula (212) extending distally from a grip portion (220).
• Cannula (212) has an open distal end (214) and a bent region (216) formed just distal to grip portion (220). Bent region (216) defines a bend angle that is selected to facilitate insertion of distal end (214) in a patient by an operator grasping grip portion (220).
• cannula (212) is rigid such that cannula (212) maintains the bend of bent region (216) and does not buckle during insertion into a patient's nasal cavity.
• cannula (212) may be formed of stainless steel (e.g., a stainless steel hypotube, etc.) and/or any other suitable rigid material.
• cannula (212) defines a lumen with a diameter of approximately 2.44 mm. Alternatively, any other suitable diameter may be used.
• cannula (212) may have an elliptical cross-sectional profile or some other non-circular cross-sectional profile, if desired.
• a non-circular cross-sectional profile may provide additional clearance for other instruments to be positioned simultaneously in the same anatomical passageway (e.g., nasal cavity) with cannula (212).
• FIGS. 7-10 show grip portion (220) in greater detail. It should be understood that the rest of the components of suction instrument assembly (200) are omitted from FIGS. 7-10, for clarity.
• Grip portion (220) of the present example includes a proximal suction conduit port (224) that is configured to couple with conduit (90). Port (224) is inserted in an opening (240) that is formed in grip portion (220), as seen in FIGS. 8 and 10.
• port (224) has a barbed configuration to promote a secure fit with an elastomeric conduit (90), though it should be understood that various other kinds of configurations may be used for port (224).
• Grip portion (220) of the present example further includes a transverse vent opening (226) formed through an upper surface (232); and a lower surface (234).
• vent opening (226) is in fluid communication with a lumen (228) formed through grip portion (220).
• vent opening (226) has a teardrop shape in the present example, though it should be understood that vent opening (226) may have any other suitable shape.
• the teardrop shape (or some other elongate shape) may enable the operator to selectively vary the amount of suction based on the longitudinal position of the operator' s thumb (or other finger) on vent opening (226).
• Lumen (228) is further in fluid communication with suction port opening (240) and a lumen (not shown) of cannula (212). It should be understood that lumen (228) of grip portion (220) and the lumen of cannula (212) cooperate to provide an unobstructed fluid path from port (224) to open distal end (214) of cannula (212).
• Surfaces (232, 234) are configured to promote gripping of grip portion (220) by an operator. In particular, as best seen in FIG. 9, each surface (232, 234) provides a respective concave contour. By way of example only, an operator may grasp grip portion (220) by placing a thumb on upper surface (232) and the side of the index finger of the same hand on lower surface (234). The oblong shape of grip portion (220) may provide the operator with substantial purchase on grip portion (220), while the configurations of surfaces (232, 234) may further secure the operator's grip.
• Grip portion (220) of the present example also includes navigation guidewire port
• navigation guidewire port (222) is in communication with lumen (228) of grip portion (220).
• Navigation guidewire (130) is slidably disposed in navigation guidewire port (222).
• Navigation guidewire (130) continues through lumen (228) of grip portion (220), and further through the lumen of cannula (212), such that the distal end of navigation guidewire (130) protrudes distally from distal end (214) of cannula (212).
• the proximal end of guidewire (130) is coupled with console (16).
• guidewire port (222) is fitted with a feature that is operable to secure the position of guidewire (130) relative to grip portion (220).
• guidewire port (222) may be fitted with a Touhy Borst leur adapter that is operable to secure the position of guidewire (130) relative to grip portion (220
• guidewire (130) of this example is configured and operable just like guidewire (30) described above.
• an operator may use IGS navigation system (1) to determine the location of the distal end of guidewire (130) within a patient, to thereby determine the location of distal end (214) of cannula (212) in the patient.
• the operator may freely slide guidewire (130) within lumen (228) of grip portion (220) and the lumen of cannula (212), to thereby facilitate probing with the distal end of guidewire (130).
• navigation guidewire port (222) is coaxially aligned with the longitudinal axis of lumen (228) of grip portion (220); while opening (240) and conduit port (224) are oriented obliquely relative to the longitudinal axis of lumen (228) of grip portion (220). In some other versions, these relationships are reversed.
• navigation guidewire port (222) may be obliquely oriented relative to the longitudinal axis of lumen (228) of grip portion (220); while opening (240) and conduit port (224) may be coaxially aligned with the longitudinal axis of lumen (228) of grip portion (220).
• opening (240) and conduit port (224) may be coaxially aligned with the longitudinal axis of lumen (228) of grip portion (220).
• suction instrument assembly (200) During use of suction instrument assembly (200), the operator may grasp grip portion (220) and position distal end (214) of cannula (212) at a target site in a patient. In some such instances, suction source (80) remains in a constantly activated state. In those instances, the operator may leave vent opening (226) uncovered as the operator positions instrument (210) relative to the patient. This may result in suction source (80) drawing suction through vent opening (226) without drawing suction through open distal end (214). During the act of positioning instrument (210), the operator may rely on navigation guidewire (130) and the rest of IGS navigation system (1) to provide image guidance as described above.
• the operator may simply cover vent opening (226) with the operator' s thumb (or otherwise cover vent opening (226)). The operator may thus selectively cover and uncover vent opening during a procedure in order to selectively apply suction.
• the operator may use navigation guidewire (130) and the rest of IGS navigation system (1) to provide image guidance to suction instrument (210) before, during, and/or after the suctioning procedure.
• suction instruments that include an integral navigation guidewire port
• a locking feature may further provide a seal that prevents the loss of suction through the navigation guidewire port.
• FIG. 11 shows an exemplary suction instrument assembly (300) that includes a suction instrument (310) having an integral navigation guidewire port (322).
• Suction instrument assembly (300) of this example further includes console (16), navigation guidewire (130), suction source (80), and conduit (90), each of which is described above.
• Suction instrument (310) of the present example includes an elongate cannula (312) extending distally from a grip portion (320).
• Cannula (312) has an open distal end (314) and a bent region (316) formed just distal to grip portion (320). Bent region (316) defines a bend angle that is selected to facilitate insertion of distal end (314) in a patient by an operator grasping grip portion (320).
• Various suitable bend angles that may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
• cannula (312) is rigid such that cannula (312) maintains the bend of bent region (316) and does not buckle during insertion into a patient's nasal cavity.
• cannula (312) may be formed of stainless steel (e.g., a stainless steel hypotube, etc.) and/or any other suitable rigid material.
• cannula (312) defines a lumen with a diameter of approximately 2.44 mm. Alternatively, any other suitable diameter may be used.
• the lumen of cannula (312) may have an elliptical cross-sectional profile or some other non-circular cross-sectional profile, if desired.
• a non-circular cross-sectional profile may provide additional clearance for other instruments to be positioned simultaneously in the same anatomical passageway (e.g., nasal cavity) with cannula (312).
• FIGS. 12-16B show grip portion (320) in greater detail.
• Grip portion (320) of the present example includes a proximal suction conduit port (324) that is configured to couple with conduit (90).
• port (324) has a barbed configuration to promote a secure fit with an elastomeric conduit (90), though it should be understood that various other kinds of configurations may be used for port (324).
• Grip portion (320) of the present example further includes a transverse vent opening (326) formed through an upper surface (332); and a lower surface (334). As best seen in FIG. 15, vent opening (326) is in fluid communication with a lumen (328) formed through grip portion (320). As best seen in FIG.
• vent opening (326) has a teardrop shape in the present example, though it should be understood that vent opening (326) may have any other suitable shape.
• the teardrop shape (or some other elongate shape) may enable the operator to selectively vary the amount of suction based on the longitudinal position of the operator's thumb (or other finger) on vent opening (326).
• Lumen (328) is further in fluid communication with suction conduit port (324) and a lumen (not shown) of cannula (312). It should be understood that lumen (328) of grip portion (320) and the lumen of cannula (312) cooperate to provide an unobstructed fluid path from port (324) to open distal end (314) of cannula (312).
• Surfaces (332, 334) are configured to promote gripping of grip portion (320) by an operator.
• upper surface (332) provides a concave contour; while lower surface (334) provides a set of ridges.
• an operator may grasp grip portion (320) by placing a thumb on upper surface (332) and the side of the index finger of the same hand on lower surface (334).
• the generally rectangular shape of grip portion (320) may provide the operator with substantial purchase on grip portion (320), while the configurations of surfaces (332, 334) may further secure the operator's grip.
• Grip portion (320) of the present example also includes navigation guidewire port
• navigation guidewire port (322) is in the form of an arm that defines an opening (340) leading to a lumen (342).
• the outer region of opening (340) is funnel-shaped or tapered to facilitate insertion of navigation guidewire (130) into opening (340) and lumen (342).
• Lumen (342) of navigation guidewire port (322) is in communication with lumen (328) of grip portion (320).
• Navigation guidewire (130) is slidably disposed in navigation guidewire port (322).
• Navigation guidewire (130) continues through lumen (328) of grip portion (320), and further through the lumen of cannula (312), such that the distal end of navigation guidewire (130) protrudes distally from distal end (314) of cannula (312).
• the proximal end of guidewire (130) is coupled with console (16).
• lumen (342) reaches lumen (328) at a point that is distal to the location of vent opening (326). This positioning may prevent guidewire (130) from inadvertently exiting vent opening (326) while guidewire (130) is being initially fed into grip portion (320).
• Grip portion (320) of the present example further includes a locking member (350), which is in the form of a push-button in the present example.
• Locking member (350) is secured to guidewire port (322) and is configured to translate transversely relative to guidewire port (322) through a limited range of motion.
• Locking member (350) defines a lumen (352) that is configured to selectively align with lumen (342) of guidewire port (322).
• a coil spring (354) is configured to urge locking member (350) toward the position shown in FIG. 14, where lumen (352) is not aligned with lumen (342). While a coil spring (354) is used to provide a resilient bias in the present example, it should be understood that any other suitable kind of resilient member may be used.
• guidewire port (322) and locking member (350) are positioned such that locking member (350) is laterally offset from the vertical plane that passes through the entire length of cannula (312) and vent opening (326). Due to this positioning, an operator may tend to use a finger (other than the thumb) of the hand that grasps grip portion (320) to actuate locking member (350). The operator may this keep vent opening (326) covered with their thumb while actuating locking member (350). Of course, an operator may actuate locking member (350) in any other suitable fashion.
• FIGS. 16A-16B show the relationship between locking member (350) and navigation guidewire (130).
• locking member (350) is in an outward position to provide a locked state.
• lumen (352) of locking member (350) is not aligned with lumen (342) of guidewire port (322).
• navigation guidewire (130) is disposed in both lumens (342, 352), the non-alignment of lumens (342, 352) provides a pinching effect on navigation guidewire (130). This pinching effect creates friction on navigation guidewire (130), thereby substantially securing the longitudinal position of navigation guidewire (130) relative to suction instrument (310).
• navigation guidewire (130) is in a locked state in FIG. 16A.
• navigation guidewire (130) If the operator wishes to translate navigation guidewire (130) relative to suction instrument (310) (i.e., to advance or retract the distal end of navigation guidewire (130) relative to distal end (314) of cannula (312)), the operator may press locking member (350) inwardly, against the bias of coil spring (354). This eventually results in the configuration shown in FIG. 16B. In this state, lumens (342, 352) are aligned with each other, thereby relieving the pinching effect on navigation guidewire (130). Navigation guidewire (130) is then capable of sliding freely relative to suction instrument (310), such that navigation guidewire (130) is in an unlocked state.
• Locking member (350) and guidewire port (322) may include structural features that cooperate to restrict the movement of locking member (350) to the range of motion depicted between FIGS. 16A-16B.
• guidewire (130) of this example is configured and operable just like guidewire (30) described above.
• an operator may use IGS navigation system (1) to determine the location of the distal end of guidewire (130) within a patient, to thereby determine the location of distal end (314) of cannula (312) in the patient.
• the operator may freely slide guidewire (130) within lumen (328) of grip portion (320) and the lumen of cannula (312), to thereby facilitate probing with the distal end of guidewire (130).
• the diameters of lumen (328) and the lumen of cannula (312) are large enough to enable an effective amount of suction to reach distal end (314) even while guidewire (130) is disposed in lumen (328) of grip portion (320) and the lumen of cannula (312).
• navigation guidewire port (322) is obliquely oriented relative to the longitudinal axis of lumen (328) of grip portion (320); while conduit port (324) is coaxially aligned with the longitudinal axis of lumen (328) of grip portion (320).
• these relationships are reversed.
• navigation guidewire port (322) may be coaxially aligned with the longitudinal axis of lumen (328) of grip portion (320); while conduit port (324) is oriented obliquely relative to the longitudinal axis of lumen (328) of grip portion (320).
• Other suitable orientations and arrangements will be apparent to those of ordinary skill in the art in view of the teachings herein.
• suction instrument assembly (300) During use of suction instrument assembly (300), the operator may grasp grip portion (320) and position distal end (314) of cannula (312) at a target site in a patient. In some such instances, suction source (80) remains in a constantly activated state. In those instances, the operator may leave vent opening (326) uncovered as the operator positions instrument (310) relative to the patient. This may result in suction source (80) drawing suction through vent opening (326) without drawing suction through open distal end (314). During the act of positioning instrument (310), the operator may rely on navigation guidewire (130) and the rest of IGS navigation system (1) to provide image guidance as described above.
• This may include manipulation of locking member (350) to enable adjustment of the longitudinal position of navigation guidewire (130) relative to suction instrument (310).
• the operator may simply cover vent opening (326) with the operator's thumb (or otherwise cover vent opening (326)). The operator may thus selectively cover and uncover vent opening during a procedure in order to selectively apply suction.
• the operator may use navigation guidewire (130) and the rest of IGS navigation system (1) to provide image guidance to suction instrument (310) before, during, and/or after the suctioning procedure. This may include using locking member (350) to selectively lock and unlock the longitudinal position of navigation guidewire (130) relative to suction instrument (310).
• locking member (350) is configured to cooperate with guidewire port (322) and navigation guidewire (130) to substantially seal guidewire port (322) when locking member (350) is in the locked position shown in FIG. 16A.
• suction instrument (310) will not lose meaningful suction through guidewire port (322).
• locking member (350) will prevent loss of suction through guidewire port (322) when a navigation guidewire (130) is not disposed in guidewire port (322).
• Other features that may be used to prevent loss of suction will be apparent to those of ordinary skill in the art in view of the teachings herein.
• FIG. 17 shows an exemplary suction instrument assembly (400) that includes a suction instrument (410).
• suction instrument (410) of this example includes an integral navigation guidewire port (440).
• Suction instrument assembly (400) of this example further includes console (16), navigation guidewire (130), suction source (80), and conduit (90), each of which is described above.
• Suction instrument (410) of the present example includes an elongate cannula (412) extending distally from a grip portion (420).
• Cannula (412) has an open distal end (414) and a bent region (416) formed just distal to grip portion (420).
• Bent region (416) defines a bend angle that is selected to facilitate insertion of distal end (414) in a patient by an operator grasping grip portion (420).
• Various suitable bend angles that may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
• cannula (412) is rigid such that cannula (412) maintains the bend of bent region (416) and does not buckle during insertion into a patient's nasal cavity.
• cannula (412) may be formed of stainless steel (e.g., a stainless steel hypotube, etc.) and/or any other suitable rigid material.
• cannula (412) defines a lumen with a diameter of approximately 2.44 mm. Alternatively, any other suitable diameter may be used.
• the lumen of cannula (412) may have an elliptical cross-sectional profile or some other non-circular cross-sectional profile, if desired.
• a non-circular cross-sectional profile may provide additional clearance for other instruments to be positioned simultaneously in the same anatomical passageway (e.g., nasal cavity) with cannula (412).
• FIGS. 18-20B show grip portion (420) in greater detail. It should be understood that the rest of the components of suction instrument assembly (400) are omitted from FIGS. 18-20B, for clarity.
• Grip portion (420) of the present example includes a proximal suction conduit port (424) that is configured to couple with conduit (90). Port (424) is inserted in an opening (425) that is formed in grip portion (420), as seen in FIGS. 20A- 20B.
• conduit port (424) has a barbed configuration to promote a secure fit with an elastomeric conduit (90), though it should be understood that various other kinds of configurations may be used for port (224).
• Grip portion (420) of the present example further includes a transverse vent opening (426) formed through an upper surface (432); and a lower surface (434). Vent opening (426) is in fluid communication with a lumen (428) formed through grip portion (420). Lumen (428) is best seen in FIGS. 20A-20B.
• vent opening (426) has a teardrop shape in the present example, though it should be understood that vent opening (426) may have any other suitable shape.
• the teardrop shape (or some other elongate shape) may enable the operator to selectively vary the amount of suction based on the longitudinal position of the operator's thumb (or other finger) on vent opening (426).
• Lumen (428) is further in fluid communication with suction port opening (425) and a lumen (not shown) of cannula (412). It should be understood that lumen (428) of grip portion (420) and the lumen of cannula (412) cooperate to provide an unobstructed fluid path from port (424) to open distal end (414) of cannula (412).
• Surfaces (432, 434) are configured to promote gripping of grip portion (420) by an operator.
• upper surface (432) provides a concave contour; while lower surface (434) is substantially flat.
• an operator may grasp grip portion (420) by placing a thumb on upper surface (432) and the side of the index finger of the same hand on lower surface (434).
• the generally rectangular shape of grip portion (420) may provide the operator with substantial purchase on grip portion (420), while the configurations of surfaces (432, 434) may further secure the operator's grip.
• Grip portion (420) of the present example also includes navigation guidewire port (440), as noted above.
• navigation guidewire port (440) is in the form of a lumen that is in communication with lumen (428) of grip portion (420).
• Navigation guidewire (130) is slidably disposed in navigation guidewire port (440).
• Navigation guidewire (130) continues through lumen (428) of grip portion (420), and further through the lumen of cannula (412), such that the distal end of navigation guidewire (130) protrudes distally from distal end (414) of cannula (412).
• the proximal end of guidewire (130) is coupled with console (16).
• Grip portion (420) of the present example further includes a locking member (450).
• Locking member (450) is secured to the body of grip portion (420) and is configured to translate longitudinally relative to the body of grip portion (420) through a limited range of motion.
• locking member (450) is configured to translate between a proximal position (FIG. 20A) and a distal position (FIG. 20B).
• grip portion (420) include a coil spring or other resilient member that resiliently biases locking member (450) to the proximal position.
• the proximal end of locking member (450) bears against the navigation guidewire (130) that is disposed in suction instrument (410), thereby providing a pinching effect against navigation guidewire (130).
• navigation guidewire (130) is in a locked state when locking member (450) is in the proximal position shown in FIG. 20A.
• navigation guidewire (130) If the operator wishes to translate navigation guidewire (130) relative to suction instrument (410) (i.e., to advance or retract the distal end of navigation guidewire (130) relative to distal end (414) of cannula (412)), the operator may advance locking member (450) distally, against the bias of the coil spring or other resilient member (not shown). This eventually results in the configuration shown in FIG. 20B. In this state, the proximal end of locking member (450) no longer bears against navigation guidewire (130), thereby relieving the pinching effect on navigation guidewire (130). Navigation guidewire (130) is then capable of sliding freely relative to suction instrument (410), such that navigation guidewire (130) is in an unlocked state.
• Locking member (450) and the body of grip portion (420) may include structural features that cooperate to restrict the movement of locking member (420) to the range of motion depicted between FIGS. 20A-20B.
• guidewire port (440) and locking member (450) are positioned such that locking member (450) is laterally offset from the vertical plane that passes through the entire length of cannula (412) and vent opening (426). Due to this positioning, an operator may tend to use a finger (other than the thumb) of the hand that grasps grip portion (420) to actuate locking member (450). The operator may this keep vent opening (426) covered with their thumb while actuating locking member (450). Of course, an operator may actuate locking member (450) in any other suitable fashion.
• guidewire (130) of this example is configured and operable just like guidewire (30) described above.
• an operator may use IGS navigation system (1) to determine the location of the distal end of guidewire (130) within a patient, to thereby determine the location of distal end (414) of cannula (412) in the patient.
• the operator may freely slide guidewire (130) within lumen (428) of grip portion (420) and the lumen of cannula (412), to thereby facilitate probing with the distal end of guidewire (130).
• the diameters of lumen (428) and the lumen of cannula (412) are large enough to enable an effective amount of suction to reach distal end (414) even while guidewire (130) is disposed in lumen (428) of grip portion (420) and the lumen of cannula (412).
• navigation guidewire port (440) is obliquely oriented relative to the longitudinal axis of lumen (428) of grip portion (420); while opening (425) of suction conduit port (424) is coaxially aligned with the longitudinal axis of lumen (428) of grip portion (420).
• these relationships are reversed.
• navigation guidewire port (440) may be coaxially aligned with the longitudinal axis of lumen (428) of grip portion (420); while opening (425) of suction conduit port (424) is oriented obliquely relative to the longitudinal axis of lumen (428) of grip portion (420).
• Other suitable orientations and arrangements will be apparent to those of ordinary skill in the art in view of the teachings herein.
• suction instrument assembly (400) During use of suction instrument assembly (400), the operator may grasp grip portion (420) and position distal end (414) of cannula (412) at a target site in a patient. In some such instances, suction source (80) remains in a constantly activated state. In those instances, the operator may leave vent opening (426) uncovered as the operator positions instrument (410) relative to the patient. This may result in suction source (80) drawing suction through vent opening (426) without drawing suction through open distal end (414).
• the operator may rely on navigation guidewire (130) and the rest of IGS navigation system (1) to provide image guidance as described above. This may include manipulation of locking member (450) to enable adjustment of the longitudinal position of navigation guidewire (130) relative to suction instrument (410).
• the operator may simply cover vent opening (426) with the operator's thumb (or otherwise cover vent opening (426)). The operator may thus selectively cover and uncover vent opening during a procedure in order to selectively apply suction.
• the operator may use navigation guidewire (130) and the rest of IGS navigation system (1) to provide image guidance to suction instrument (410) before, during, and/or after the suctioning procedure. This may include using locking member (450) to selectively lock and unlock the longitudinal position of navigation guidewire (130) relative to suction instrument (410).
• locking member (450) is configured to cooperate with the body of grip portion (420) and navigation guidewire (130) to substantially seal guidewire port (440) when locking member (450) is in the locked position shown in FIG. 20A.
• suction instrument (410) will not lose meaningful suction through guidewire port (440).
• locking member (450) will prevent loss of suction through guidewire port (440) when a navigation guidewire (130) is not disposed in guidewire port (440).
• Other features that may be used to prevent loss of suction will be apparent to those of ordinary skill in the art in view of the teachings herein.
• FIG. 21 shows an exemplary suction instrument assembly (500) that includes a suction instrument (510) having an integral navigation guidewire port (522).
• Suction instrument assembly (500) of this example further includes console (16), navigation guidewire (130), suction source (80), and conduit (90), each of which is described above.
• Suction instrument (510) of the present example includes an elongate cannula (512) extending distally from a grip portion (520).
• Cannula (512) has an open distal end (514) and a bent region (516) formed just distal to grip portion (520).
• Bent region (516) defines a bend angle that is selected to facilitate insertion of distal end (514) in a patient by an operator grasping grip portion (520).
• Various suitable bend angles that may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
• cannula (512) is rigid such that cannula (512) maintains the bend of bent region (516) and does not buckle during insertion into a patient's nasal cavity.
• cannula (512) may be formed of stainless steel (e.g., a stainless steel hypotube, etc.) and/or any other suitable rigid material.
• cannula (512) defines a lumen with a diameter of approximately 2.44 mm. Alternatively, any other suitable diameter may be used.
• the lumen of cannula (512) may have an elliptical cross-sectional profile or some other non-circular cross-sectional profile, if desired.
• a non-circular cross-sectional profile may provide additional clearance for other instruments to be positioned simultaneously in the same anatomical passageway (e.g., nasal cavity) with cannula (512).
• FIGS. 22-25B show grip portion (520) in greater detail. It should be understood that the rest of the components of suction instrument assembly (500) are omitted from FIGS. 22-25B, for clarity.
• Grip portion (520) of the present example includes a proximal suction conduit port (524) that is configured to couple with conduit (90).
• port (524) has a barbed configuration to promote a secure fit with an elastomeric conduit (90), though it should be understood that various other kinds of configurations may be used for port (524).
• Grip portion (520) of the present example further includes a transverse vent opening (526) formed through an upper surface (532); and a lower surface (534). As best seen in FIG.
• vent opening (526) is in fluid communication with a lumen (538) formed through grip portion (520).
• vent opening (526) has a teardrop shape in the present example, though it should be understood that vent opening (526) may have any other suitable shape.
• the teardrop shape (or some other elongate shape) may enable the operator to selectively vary the amount of suction based on the longitudinal position of the operator' s thumb (or other finger) on vent opening (526).
• Lumen (538) is further in fluid communication with suction conduit port (524) and a lumen (not shown) of cannula (512). It should be understood that lumen (538) of grip portion (520) and the lumen of cannula (512) cooperate to provide an unobstructed fluid path from port (524) to open distal end (514) of cannula (512).
• Surfaces (532, 534) are configured to promote gripping of grip portion (520) by an operator.
• each surface (532, 534) provides a respective concave contour.
• an operator may grasp grip portion (520) by placing a thumb on upper surface (532) and the side of the index finger of the same hand on lower surface (534).
• the generally rectangular shape of grip portion (520) may provide the operator with substantial purchase on grip portion (520), while the configurations of surfaces (532, 534) may further secure the operator's grip.
• Grip portion (520) of the present example also includes navigation guidewire port (522), as noted above.
• navigation guidewire port (522) is in the form of an arm that defines an opening (540) leading to a lumen (542).
• the outer region of opening (540) is funnel-shaped or tapered to facilitate insertion of navigation guidewire (130) into opening (540) and lumen (542).
• Lumen (542) of navigation guidewire port (522) is in communication with lumen (538) of grip portion (520).
• Navigation guidewire (130) is slidably disposed in navigation guidewire port (522).
• Navigation guidewire (130) continues through lumen (538) of grip portion (520), and further through the lumen of cannula (512), such that the distal end of navigation guidewire (130) protrudes distally from distal end (514) of cannula (512).
• the proximal end of guidewire (130) is coupled with console (16).
• Grip portion (520) of the present example further includes a locking member (550), which is in the form of a push-button in the present example.
• Locking member (550) is secured to guidewire port (522) and is configured to translate transversely relative to guidewire port (522) through a limited range of motion.
• Locking member (550) defines a lumen (552) that is configured to selectively align with lumen (542) of guidewire port (522).
• a coil spring (554) is configured to urge locking member (550) toward the position shown in FIG. 24, where lumen (552) is not aligned with lumen (542). While a coil spring (554) is used to provide a resilient bias in the present example, it should be understood that any other suitable kind of resilient member may be used.
• guidewire port (522) and locking member (550) are positioned such that locking member (550) is aligned with the vertical plane that passes through the entire length of cannula (512) and vent opening (526). Due to this positioning, an operator may tend to use the thumb of the hand that grasps grip portion (520) to actuate locking member (550). This may be the same thumb that selectively covers and uncovers vent opening (526). The operator may thus transition between keeping vent opening (526) covered with their thumb and actuating locking member (550). Of course, an operator may actuate locking member (550) in any other suitable fashion.
• FIGS. 25A-25B show the relationship between locking member (550) and navigation guidewire (130).
• locking member (550) is in an outward position to provide a locked state.
• lumen (552) of locking member (550) is not aligned with lumen (542) of guidewire port (522).
• navigation guidewire (130) is disposed in both lumens (542, 552), the non-alignment of lumens (542, 552) provides a pinching effect on navigation guidewire (130). This pinching effect creates friction on navigation guidewire (130), thereby substantially securing the longitudinal position of navigation guidewire (130) relative to suction instrument (510).
• navigation guidewire (130) is in a locked state in FIG. 25A.
• navigation guidewire (130) If the operator wishes to translate navigation guidewire (130) relative to suction instrument (510) (i.e., to advance or retract the distal end of navigation guidewire (130) relative to distal end (514) of cannula (512)), the operator may press locking member (550) inwardly, against the bias of coil spring (554). This eventually results in the configuration shown in FIG. 25B. In this state, lumens (542, 552) are aligned with each other, thereby relieving the pinching effect on navigation guidewire (130). Navigation guidewire (130) is then capable of sliding freely relative to suction instrument (510), such that navigation guidewire (130) is in an unlocked state.
• Locking member (550) and guidewire port (522) may include structural features that cooperate to restrict the movement of locking member (550) to the range of motion depicted between FIGS. 25A-25B.
• guidewire (130) of this example is configured and operable just like guidewire (30) described above.
• an operator may use IGS navigation system (1) to determine the location of the distal end of guidewire (130) within a patient, to thereby determine the location of distal end (514) of cannula (512) in the patient.
• the operator may freely slide guidewire (130) within lumen (538) of grip portion (520) and the lumen of cannula (512), to thereby facilitate probing with the distal end of guidewire (130).
• the diameters of lumen (538) and the lumen of cannula (512) are large enough to enable an effective amount of suction to reach distal end (514) even while guidewire (130) is disposed in lumen (538) of grip portion (520) and the lumen of cannula (512).
• navigation guidewire port (522) is obliquely oriented relative to the longitudinal axis of lumen (538) of grip portion (520); while conduit port (524) is coaxially aligned with the longitudinal axis of lumen (538) of grip portion (520).
• these relationships are reversed.
• navigation guidewire port (522) may be coaxially aligned with the longitudinal axis of lumen (538) of grip portion (520); while conduit port (524) is oriented obliquely relative to the longitudinal axis of lumen (538) of grip portion (520).
• Other suitable orientations and arrangements will be apparent to those of ordinary skill in the art in view of the teachings herein.
• suction instrument assembly (500) the operator may grasp grip portion (520) and position distal end (514) of cannula (512) at a target site in a patient.
• suction source (80) remains in a constantly activated state.
• the operator may leave vent opening (526) uncovered as the operator positions instrument (510) relative to the patient. This may result in suction source (80) drawing suction through vent opening (526) without drawing suction through open distal end (514).
• the operator may rely on navigation guidewire (130) and the rest of IGS navigation system (1) to provide image guidance as described above. This may include manipulation of locking member (550) to enable adjustment of the longitudinal position of navigation guidewire (130) relative to suction instrument (510).
• the operator may simply cover vent opening (526) with the operator's thumb (or otherwise cover vent opening (526)). The operator may thus selectively cover and uncover vent opening during a procedure in order to selectively apply suction.
• the operator may use navigation guidewire (130) and the rest of IGS navigation system (1) to provide image guidance to suction instrument (510) before, during, and/or after the suctioning procedure. This may include using locking member (550) to selectively lock and unlock the longitudinal position of navigation guidewire (130) relative to suction instrument (510).
• locking member (550) is configured to cooperate with guidewire port (540) and navigation guidewire (130) to substantially seal guidewire port (540) when locking member (550) is in the locked position shown in FIG. 25A.
• suction instrument (510) will not lose meaningful suction through guidewire port (540).
• locking member (550) will prevent loss of suction through guidewire port (540) when a navigation guidewire (130) is not disposed in guidewire port (540).
• Other features that may be used to prevent loss of suction will be apparent to those of ordinary skill in the art in view of the teachings herein.
• FIG. 26 shows an exemplary suction instrument assembly (600) that includes a suction instrument (610) having an integral navigation guidewire port (640).
• Suction instrument assembly (600) of this example further includes console (16), navigation guidewire (130), suction source (80), and conduit (90), each of which is described above.
• Suction instrument (610) of the present example includes an elongate cannula (612) extending distally from a grip portion (620).
• Cannula (612) has an open distal end (614) and a bent region (616) formed just distal to grip portion (620). Bent region (616) defines a bend angle that is selected to facilitate insertion of distal end (614) in a patient by an operator grasping grip portion (620).
• Various suitable bend angles that may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
• cannula (612) is rigid such that cannula (612) maintains the bend of bent region (616) and does not buckle during insertion into a patient's nasal cavity.
• cannula (612) may be formed of stainless steel (e.g., a stainless steel hypotube, etc.) and/or any other suitable rigid material.
• cannula (612) defines a lumen with a diameter of approximately 2.44 mm. Alternatively, any other suitable diameter may be used.
• the lumen of cannula (612) may have an elliptical cross-sectional profile or some other non-circular cross-sectional profile, if desired.
• a non-circular cross-sectional profile may provide additional clearance for other instruments to be positioned simultaneously in the same anatomical passageway (e.g., nasal cavity) with cannula (612).
• FIGS. 27-3 IB show grip portion (620) in greater detail. It should be understood that the rest of the components of suction instrument assembly (600) are omitted from FIGS. 27-3 IB, for clarity.
• Grip portion (620) of the present example includes a proximal suction conduit port (624) that is configured to couple with conduit (90).
• port (624) has a barbed configuration to promote a secure fit with an elastomeric conduit (90), though it should be understood that various other kinds of configurations may be used for port (624).
• Grip portion (620) of the present example further includes a transverse vent opening (626) formed through an upper surface (632); and a lower surface (634). As best seen in FIG.
• vent opening (626) is in fluid communication with a lumen (628) formed through grip portion (620).
• vent opening (626) has a teardrop shape in the present example, though it should be understood that vent opening (626) may have any other suitable shape.
• the teardrop shape (or some other elongate shape) may enable the operator to selectively vary the amount of suction based on the longitudinal position of the operator' s thumb (or other finger) on vent opening (626).
• Lumen (628) is further in fluid communication with suction conduit port (624) and a lumen (not shown) of cannula (612). It should be understood that lumen (638) of grip portion (620) and the lumen of cannula (612) cooperate to provide an unobstructed fluid path from port (624) to open distal end (614) of cannula (612).
• Surfaces (632, 634) are configured to promote gripping of grip portion (620) by an operator.
• upper surface (632) provides a concave contour; while lower surface (634) provides a set of ridges.
• an operator may grasp grip portion (620) by placing a thumb on upper surface (632) and the side of the index finger of the same hand on lower surface (634).
• the generally rectangular shape of grip portion (620) may provide the operator with substantial purchase on grip portion (620), while the configurations of surfaces (632, 634) may further secure the operator's grip.
• Grip portion (620) of the present example also includes navigation guidewire port (640), as noted above.
• navigation guidewire port (640) is in the form of an opening that is coaxially aligned with lumen (628).
• the outer region of navigation guidewire port (640) is funnel-shaped or tapered to facilitate insertion of navigation guidewire (130) into navigation guidewire port (640).
• Navigation guidewire (130) is slidably disposed in navigation guidewire port (640).
• Navigation guidewire (130) continues through lumen (628) of grip portion (620), and further through the lumen of cannula (612), such that the distal end of navigation guidewire (130) protrudes distally from distal end (614) of cannula (612).
• the proximal end of guidewire (130) is coupled with console (16).
• Grip portion (620) of the present example further includes a locking member (650), which is in the form of a push-button in the present example.
• Locking member (650) is secured to the body of grip portion (620) and is configured to translate transversely relative to guidewire port (640) through a limited range of motion.
• locking member (650) defines a lumen (652) that is configured to selectively align with guidewire port (640) and lumen (628) of grip portion (620).
• grip portion (620) include a coil spring or other resilient member that resiliently biases locking member (550) to the outer position shown in FIG. 29.
• guidewire port (640) and locking member (650) are positioned such that locking member (650) is laterally offset from the vertical plane that passes through the entire length of cannula (612) and vent opening (626). Due to this positioning, an operator may tend to use a finger (other than the thumb) of the hand that grasps grip portion (620) to actuate locking member (650). The operator may this keep vent opening (626) covered with their thumb while actuating locking member (650). Of course, an operator may actuate locking member (650) in any other suitable fashion.
• FIGS. 31A-31B show the relationship between locking member (650) and navigation guidewire (130).
• locking member (650) is in an outward position to provide a locked state.
• lumen (652) of locking member (550) is not aligned with guidewire port (640) or lumen (628) of grip portion (620).
• the non-alignment of port (640) and lumens (628, 654) provides a pinching effect on navigation guidewire (130). This pinching effect creates friction on navigation guidewire (130), thereby substantially securing the longitudinal position of navigation guidewire (130) relative to suction instrument (610).
• navigation guidewire (130) is in a locked state in FIG. 31 A.
• navigation guidewire (130) If the operator wishes to translate navigation guidewire (130) relative to suction instrument (610) (i.e., to advance or retract the distal end of navigation guidewire (130) relative to distal end (614) of cannula (612)), the operator may press locking member (650) inwardly, against the bias of the coil spring or other resilient member that biases locking member (650). This eventually results in the configuration shown in FIG. 3 IB. In this state, port (640) and lumens (628, 654) are aligned with each other, thereby relieving the pinching effect on navigation guidewire (130). Navigation guidewire (130) is then capable of sliding freely relative to suction instrument (610), such that navigation guidewire (130) is in an unlocked state.
• Locking member (650) and the body of grip portion (620) may include structural features that cooperate to restrict the movement of locking member (650) to the range of motion depicted between FIGS. 31 A- 3 IB.
• guidewire (130) of this example is configured and operable just like guidewire (30) described above.
• an operator may use IGS navigation system (1) to determine the location of the distal end of guidewire (130) within a patient, to thereby determine the location of distal end (614) of cannula (612) in the patient.
• the operator may freely slide guidewire (130) within lumen (628) of grip portion (620) and the lumen of cannula (612), to thereby facilitate probing with the distal end of guidewire (130).
• the diameters of lumen (628) and the lumen of cannula (612) are large enough to enable an effective amount of suction to reach distal end (614) even while guidewire (130) is disposed in lumen (628) of grip portion (620) and the lumen of cannula (512).
• navigation guidewire port (640) is coaxially aligned with the longitudinal axis of lumen (628) of grip portion (620); while conduit port (624) is oriented obliquely relative to the longitudinal axis of lumen (628) of grip portion (620). In some other versions, these relationships are reversed. In other words, navigation guidewire port (640) may be obliquely oriented relative to the longitudinal axis of lumen (628) of grip portion (620); while conduit port (624) is coaxially aligned with the longitudinal axis of lumen (638) of grip portion (620). Other suitable orientations and arrangements will be apparent to those of ordinary skill in the art in view of the teachings herein.
• suction instrument assembly (600) the operator may grasp grip portion (620) and position distal end (614) of cannula (612) at a target site in a patient.
• suction source (80) remains in a constantly activated state.
• the operator may leave vent opening (626) uncovered as the operator positions instrument (610) relative to the patient. This may result in suction source (80) drawing suction through vent opening (626) without drawing suction through open distal end (614).
• the operator may rely on navigation guidewire (130) and the rest of IGS navigation system (1) to provide image guidance as described above. This may include manipulation of locking member (650) to enable adjustment of the longitudinal position of navigation guidewire (130) relative to suction instrument (610).
• the operator may simply cover vent opening (626) with the operator's thumb (or otherwise cover vent opening (626)). The operator may thus selectively cover and uncover vent opening during a procedure in order to selectively apply suction.
• the operator may use navigation guidewire (130) and the rest of IGS navigation system (1) to provide image guidance to suction instrument (610) before, during, and/or after the suctioning procedure. This may include using locking member (650) to selectively lock and unlock the longitudinal position of navigation guidewire (130) relative to suction instrument (610).
• locking member (650) is configured to cooperate with guidewire port (640) and navigation guidewire (130) to substantially seal guidewire port (640) when locking member (650) is in the locked position shown in FIG. 31 A.
• suction instrument (610) will not lose meaningful suction through guidewire port (640).
• locking member (650) will prevent loss of suction through guidewire port (640) when a navigation guidewire (130) is not disposed in guidewire port (640).
• Other features that may be used to prevent loss of suction will be apparent to those of ordinary skill in the art in view of the teachings herein.
• An apparatus comprising: (a) a cannula including: (i) a proximal end, (ii) a distal end, and (iii) a first lumen extending from the proximal end to the distal end, wherein the cannula is formed of a rigid material; and (b) a grip portion secured to the proximal end of the cannula, wherein the grip portion includes: (i) a second lumen, wherein the second lumen is in communication with the first lumen, (ii) a transversely oriented vent port, wherein the transversely oriented vent port is configured to communicate with the second lumen to thereby vent the second lumen to atmosphere, (iii) a suction port, wherein the suction port is configured to communicate with the second lumen to thereby communicate suction to the distal end of the cannula via the first lumen, and (iv) a guidewire port, wherein the guidewire port is configured to receive a guidewire,
• Example 1 The apparatus of Example 1, wherein the cannula further includes a preformed bend formed between the proximal end and the distal end.
• Example 7 The apparatus of any one or more of Examples 1 through 3, wherein the second lumen defines a longitudinal axis, wherein the guidewire port is oriented obliquely relative to the longitudinal axis.
• Example 6 The apparatus of Example 6, wherein the suction port is coaxially aligned with the longitudinal axis.
• Example 9 The apparatus of Example 9, wherein the vent port is located at a first longitudinal position along the second lumen, wherein the third lumen distally terminates at the second lumen at a second longitudinal position along the second lumen, wherein the second longitudinal position is distal to the first longitudinal position.
• the grip portion further includes a locking feature, wherein the locking feature is configured to selectively engage a guidewire disposed in the guidewire port to thereby selectively secure the position of the guidewire relative to the grip portion by moving between a locked position and an unlocked position.
• Example 12 [000169] The apparatus of Example 11, wherein the grip portion further includes: (i) a body, wherein the vent port is formed in the body, and (ii) an arm extending obliquely from the body, wherein the guidewire port is located on the arm, wherein the locking feature is located on the arm.
• Example 12 The apparatus of Example 12, wherein the locking feature comprises a button, wherein the button is configured to translate transversely relative to a longitudinal axis defined by the arm to thereby transition between the locked position and the unlocked position.
• Example 18 The apparatus of one or more of Examples 11 through 16, wherein the locking feature is further configured to provide a fluid seal of the guidewire port when the locking feature is in the locked position.
• the guidewire port defines a third lumen
• the locking feature defines a fourth lumen
• the third and fourth lumens are configured to receive the guidewire
• the locking feature in the unlocked position is configured to provide alignment of the third and fourth lumens
• the locking feature in the locked position is configured to provide non- alignment of the third and fourth lumens.
• An apparatus comprising: (a) a cannula including: (i) a proximal end, (ii) a distal end, and (iii) a first lumen extending from the proximal end to the distal end, wherein the cannula is formed of a rigid material; and (b) a grip portion secured to the proximal end of the cannula, wherein the grip portion includes: (i) a second lumen, wherein the second lumen is in communication with the first lumen, (ii) a suction port, wherein the suction port is configured to communicate with the second lumen to thereby communicate suction to the distal end of the cannula via the first lumen, (iii) a guidewire port, wherein the guidewire port is configured to receive a guidewire, wherein the guidewire port is further configured to communicate with the second lumen to thereby provide a path for the guidewire to reach the first lumen, and (iv) a locking feature, where
• An apparatus comprising: (a) a cannula including: (i) a proximal end, (ii) a distal end, and (iii) a first lumen extending from the proximal end to the distal end; (b) a grip portion secured to the proximal end of the cannula, wherein the grip portion includes: (i) a second lumen, wherein the second lumen is in communication with the first lumen, (ii) a suction port, wherein the suction port is configured to communicate with the second lumen to thereby communicate suction to the distal end of the cannula via the first lumen, and (iii) a guidewire port, wherein the guidewire port is configured to receive a guidewire, wherein the guidewire port is further configured to communicate with the second lumen to thereby provide a path for the guidewire to reach the first lumen; and (c) a navigation guidewire configured to fit in the guidewire port, wherein the navigation guidewire is further
• a method of applying suction in a patient comprising: (a) inserting a cannula into a patient, wherein the cannula defines a lumen; (b) identifying a location of the cannula in the patient based on image feedback from a navigation system, wherein the navigation system includes a guidewire with a sensor, wherein the guidewire is disposed in the lumen of the cannula; (c) positioning a distal end of the cannula at a target site in the patient based on image feedback from the navigation system; and (d) applying suction at the target site via the lumen and the distal end of the cannula.
• Example 21 The method of Example 21, wherein the act of inserting the cannula into the patient comprises inserting the cannula into a nasal cavity of the patient.
• Example 25 The method of any one or more of Examples 21 through 23, further comprising inserting the guidewire into the lumen of the cannula. [000194] Example 25
• Example 26 The method of Example 26, wherein the sensor provides a variable signal based on the location of the sensor within the electromagnetic field.
• Example 28 The method of Example 28, wherein the act of applying suction comprises covering the vent opening.
• Example 31 The method of any one or more of Examples 28 through 29, wherein the vent opening is uncovered during the acts of inserting the cannula of the patient and positioning the distal end of the cannula at the target site.
• Example 31 The method of Example 31, wherein the act of selectively locking comprises releasing an actuator.
• Example 32 The method of Example 32, further comprising selectively unlocking the longitudinal position of the guidewire relative to the cannula.
• Example 33 The method of Example 33, wherein the act of selectively unlocking comprises actuating the actuator.
• Example 34 The method of Example 34, wherein the act of actuating the actuator comprise pressing the actuator in a direction transverse to a longitudinal axis of the guidewire.
• navigation guidewires (130) that are configured for use with an IGS navigation system (1).
• the same instruments 60, 210, 310, 410, 510, 610) may also be used with any other suitable conventional guidewire.
• the above teachings may be readily applied in contexts where navigation guidewire (130) is substituted with a guidewire having one or more optical fibers that are operable to transmit light to the distal end of the guidewire.
• Such an illuminating guidewire may be provided in accordance with the teachings of U.S. Pat. No.
• a navigation coil or other navigation sensor in the distal end of guidewire (30, 130) to enable navigation and guidance via IGS system (1).
• some versions may also incorporate one or more navigation coils or other navigation sensors in one or more other locations.
• one or more other navigation coils or other navigation sensors in grip portions (70, 220, 320, 420, 520, 620) and/or in some other component that will remain external to the patient during use of the device.
• grip portions 70, 220, 320, 420, 520, 620
• any of the devices herein may be modified and/or used in accordance with at least some of the teachings of U.S. Pub. No. 2016/0310042, entitled “System and Method to Map Structures of Nasal Cavity,” published October 27, 2016, the disclosure of which is incorporated by reference herein.
• the devices herein may be used to provide mapping of anatomy within and adjacent to a patient's nasal cavity.
• the devices herein may be used to provide probing of anatomy within and adjacent to a patient's nasal cavity.
• any of the examples described herein may include various other features in addition to or in lieu of those described above.
• any of the examples described herein may also include one or more of the various features disclosed in any of the various references that are incorporated by reference herein.
• Versions of the devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure.
• reconditioning of a device may 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 application.
• versions described herein may be processed before surgery.
• a new or used instrument may be obtained and if necessary cleaned.
• the instrument may be placed in a reprocessing tray (e.g., a metal bin or basket) and then cleaned in a surgical instrument washer.
• the instrument may then be sterilized.
• the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag.
• the container and instrument may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high- energy electrons.
• the radiation may kill bacteria on the instrument and in the container.
• the sterilized instrument may then be stored in the sterile container.
• the sealed container may keep the instrument sterile until it is opened in a surgical facility.
• a device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, steam, hydrogen peroxide vapor (e.g., via a STERRAD sterilization system by Advanced Sterilization Products of Irvine, California), and/or using any other suitable systems or techniques.

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• 2018
  • 2018-02-01 EP EP18704813.7A patent/EP3576647A1/de not_active Withdrawn

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