Patent Application
20210308435
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The ET (26) is a narrow channel connecting the middle ear (14) with the nasopharynx (30). The ET (26) functions as a pressure equalizing valve for the middle ear (14), which is normally filled with air. When functioning properly, the ET (26) opens for a fraction of a second periodically in response to swallowing or yawning. In so doing, it allows air into the middle ear (14) to replace air that has been absorbed by the middle ear lining (mucous membrane) or to equalize pressure changes occurring on altitude changes. Anything that interferes with this periodic opening and closing of the ET (26) may result in hearing impairment or other ear symptoms. Obstruction or blockage of the ET (26) results in a negative middle ear (14) pressure, with retraction (sucking in) of the eardrum (22). This may be accompanied by some ear discomfort, such as a fullness or pressure feeling, and may result in a mild hearing impairment and head noise (tinnitus). If the obstruction is prolonged, the middle ear (14) may eventually become infected.
Methods for treating the middle ear (14) and the ET (26) include those disclosed in U.S. Patent Pub. No. 2010/0274188, entitled “Method and System for Treating Target Tissue within the ET,” published on Oct. 28, 2010, the disclosure of which is incorporated by reference herein; U.S. Patent Pub. No. 2013/0274715, entitled “Method and System for Eustachian Tube Dilation,” published on Oct. 17, 2013, the disclosure of which is incorporated by reference herein; and U.S. Patent Pub. No. 2015/0374963, entitled “Vent Cap for a Eustachian Tube Dilation System,” published on Dec. 31, 2015, the disclosure of which is incorporated by reference herein. As described in those references, functioning of the ET (26) may be improved by dilating the ET (26) with an expandable dilator instrument.
While a variety of surgical instruments have been made and used, it is believed that no one prior to the inventors has made or used the invention described in the appended claims.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.
The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
For clarity of disclosure, the terms “proximal” and “distal” are defined herein relative to a surgeon, or other operator, grasping a surgical instrument having a distal surgical end effector. The term “proximal” refers to the position of an element arranged closer to the surgeon, and the term “distal” refers to the position of an element arranged closer to the surgical end effector of the surgical instrument and further away from the surgeon. Moreover, to the extent that spatial terms such as “upper,” “lower,” “vertical,” “horizontal,” or the like are used herein with reference to the drawings, it will be appreciated that such terms are used for exemplary description purposes only and are not intended to be limiting or absolute. In that regard, it will be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions not limited to those shown and described herein.
As used herein, the terms “about” and “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.
I. Exemplary Eustachian Tube Dilation Catheter System
One example of a treatment that may be performed to treat an ET (26) that does not provide sufficient communication between the middle ear (14) and the pharyngeal ostium (28) includes accessing and dilating the ET (26) using a guide catheter (100) and a balloon dilation catheter (200), examples of which are shown in
As shown in
Balloon (204) may be expanded to dilate the ET (26) after balloon (204) is placed in a desirable location in the ET (26). For example, dilation catheter (200) may be advanced to position the balloon (204) in the pharyngeal ostium (28) as shown in
Balloon dilation catheter (200) further includes an actuator (210). Actuator (210) has a proximal side (220) and a distal side (222). The portion (240) of elongate shaft (202) that is distal of actuator (210) is sufficiently stiff to be guided through the nasal cavity and into the ET (26). The portion (238) of elongate shaft (202) that is proximal of actuator (210) and the portion (250) that is distal to portion (240) is more flexible than the portion (240). The distal end (218) of balloon catheter (200) further includes a tip (212) and a flexible shaft portion (250) that extends from the distal end of the elongate shaft (202) to the proximal end of balloon (204). In the example shown in
After balloon (204) is positioned within the ET (26) and inflated to an expanded state (e.g., as shown in
II. Exemplary Instrument for Dilating Eustachian Tube via Middle Ear, and Related Surgical Navigation System
In some instances, it may be difficult or impossible to access the ET (26) by inserting instruments through the nostril, into the oro-nasal cavity, and through the pharyngeal ostium, as shown in
The exemplary alternative dilation instrument (300) described below enables a practitioner to safely access the ET (26) via the middle ear (14) while still being operable to provide sufficient dilation of the ET (26) once positioned.
A. Exemplary Guidewire Having Inflatable Balloon
Guidewire shaft (302) of the present example is suitably constructed with a lateral flexibility and a column strength (i.e., stiffness) sufficient to enable guidewire (300) to resiliently conform to the tortuous internal path extending between the middle ear (14) and the ET (26) of a patient without buckling or otherwise plastically deforming, and without an outer guidance device such as guide catheter (100). For instance, at least a portion of shaft (302) may be formed of braided stainless steel. In other examples, at least a portion of shaft (302) may be constructed with an outer coil and an inner core-wire. In various examples, guidewire shaft (302) may be formed of one or more metal materials such as 316 stainless steel, titanium, cobalt-chrome, nitinol, MP35N steel alloy, or various other suitable materials as disclosed in U.S. Pat. Pub. No. 2016/0008083, entitled “Guidewire Navigation for Sinuplasty,” published Jan. 14, 2016, the disclosure of which is incorporated by reference herein.
Guidewire (300) of the present example further includes an expandable element in the form of an inflatable balloon (308) secured to an exterior of guidewire shaft (302) proximal to distal tip (306). Balloon (308) may be compliant, semi-compliant, or non-compliant in construction, and may be formed of any suitable polymeric material such as polyethylene terepthalate (PET), PEBAX® (polyether block amide), nylon, or the like. Balloon (308) of the present example is suitably sized and configured to provide guidewire (300) with a maximum outer diameter of less than or equal to approximately 1 millimeter when balloon (308) is deflated, as shown in
As shown best in
Though not shown, guidewire (300) may be actuated with an actuating device of any suitable type that may be held and operated by a user, and which may have features similar to those disclosed in U.S. patent application Ser. No. 15/840,346, entitled “Dilation Instrument with Proximally Located Force Sensor,” filed Dec. 13, 2017, the disclosure of which is incorporated by reference herein.
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B. Exemplary Surgical Navigation System Incorporating Guidewire
Image-guided surgery (IGS) is a technique in which 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. In some IGS procedures, a digital tomographic scan (e.g., CT or MRI, 3-D map, etc.) of the operative field is obtained prior to surgery and converted into a digital map. Instruments having sensors mounted thereon are used to perform a surgical 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. The tomographic scan images are displayed on a system display device (e.g., 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 features shown in the scan images.
Navigation sensor (316) is provided in the form of one or more electrically conductive coils in the present example. The presence of navigation sensor (316) in the alternating magnetic generated by field generators (406) field induces an electrical current in sensor (316), which is communicated as an electric signal proximally through sensor wires (318) to a processor (408) of surgical navigation system (400). Processor (408) receives the signals and executes an algorithm to determine a location of navigation sensor (316) within a three-dimensional space occupied by the alternating electromagnetic field, which surrounds head (H) of patient (P) in the present example. Processor (408) correlates this three-dimensional space to the known anatomy of patient (P), analyzed preoperatively, and determines the three-dimensional location of sensor (316) with patient (P).
Processor (408) of surgical navigation system (400) comprises a processing unit that communicates with one or more memories and is configured to control field generators (406) and other elements of navigation system (400). In the present example, processor (408) is mounted in a console (410), which comprises operating controls (412) that include a keypad and/or a pointing device such as a mouse or trackball. A physician uses operating controls (412) to interact with processor (408) while performing the surgical procedure. Processor (408) uses software stored in a memory of processor (408) to calibrate and operate system (400). Such operation includes driving field generators (406), processing data received from navigation sensor (316), processing data from operating controls (412), and driving a display (414).
Guidewire navigation sensor (316) of the present example communicates with system processor (408) via a communication unit (416) that is coupled with a proximal end of guidewire (300), as shown schematically in
System display (414) is operable to depict a navigation image (418) that shows the real-time position of distal end (304) of guidewire (300) in relation to anatomy of patient (P). The anatomy may be presented by navigation image (418) in the form of a video camera image, a CT scan image, and/or a computer generated three-dimensional model of the anatomy, which may be displayed simultaneously and/or superimposed on each other, for instance. In addition to the anatomy image, navigation image (418) shows a graphical representation of guidewire (300). This graphical representation is superimposed on the anatomy image and enables the physician to identify the position of distal end (304) of guidewire (300) relative to adjacent anatomical features of patient (P) in real-time during a surgical procedure. By way of example only, display (414) may depict navigation image (418) in accordance with at least some of the teachings of U.S. Pat. Pub. No. 2016/0008083, entitled “Guidewire Navigation for Sinuplasty,” incorporated by reference above.
The IGS components of surgical navigation system (400) may be further configured in accordance with one or more teachings of U.S. Pat. No. 7,720,521, entitled “Methods and Devices for Performing Procedures within the Ear, Nose, Throat and Paranasal Sinuses,” issued May 18, 2010, the disclosure of which is incorporated by reference herein; U.S. Pat. Pub. No. 2016/0310042, entitled “System and Method to Map Structures of Nasal Cavity,” published Oct. 27, 2016, the disclosure of which is incorporated by reference herein; and 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 Dec. 11, 2014, the disclosure of which is incorporated by reference herein.
C. Exemplary Method of Dilating Eustachian Tube Using Guidewire
Those of ordinary skill in the art will recognize that the tympanic membrane (22) provides a physical barrier to passage of an instrument such as balloon catheter (400) from the ear canal (20) into the ET (26). Thus, an operator must somehow address the presence of the tympanic membrane (22) in order to gain access to the ET (26) from the ear canal (20). The following description provides a merely illustrative method for handling the tympanic membrane (22) in order to suitably insert guidewire (300) into the ET (26) via the ear canal (20). Other illustrative methods are disclosed in U.S. Pat. Pub. No. 2017/0119583, entitled “System and Method for Treatment of Eustachian Tube from Middle Ear Approach,” published on May 4, 2017, the disclose of which is incorporated by reference herein.
In the example shown in
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Following removal of balloon guidewire (300), the ET (26) is left dilated and able to resume normal functioning. Also following removal of guidewire (300) from the patient, the operator may replace flap (506) as generally shown in
III. Exemplary Combinations
The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.
A guidewire comprising: (a) a guidewire shaft, wherein at least a portion of the guidewire shaft is comprised of metal, wherein the guidewire shaft includes a lumen; and (b) an inflatable element arranged at a distal end of the guidewire shaft, wherein an interior of the inflatable element fluidly communicates with the lumen, wherein the inflatable element is operable to transition between a deflated state in which the inflatable element is configured to pass through an isthmus of a Eustachian tube (ET), and an inflated state in which the inflatable element is configured to dilate the ET.
The guidewire of Example 1, wherein at least a portion of the guidewire shaft is comprised of braided stainless steel.
The guidewire of any of the previous Examples, wherein the lumen extends along a central axis of the guidewire shaft.
The guidewire of any of the previous Examples, further comprising a closed distal tip.
The guidewire of any of Example 4, wherein the closed distal tip is sized and configured to pass through the isthmus of the ET.
The guidewire of any of the previous Examples, wherein the inflatable element comprises a balloon.
The guidewire of any of the previous Examples, wherein the guidewire is configured to assume a maximum outer diameter of 1 millimeter or less when the inflatable element is in the deflated state.
The guidewire of any of the previous Examples, wherein the inflatable element is configured to provide the guidewire with a maximum outer diameter of at least 6 millimeters when the inflatable element is in the inflated state.
The guidewire of any of the previous Examples, further comprising a navigation sensor operable to generate a signal corresponding to a location of a distal end of the guidewire within a patient.
The guidewire of Example 9, wherein the navigation sensor comprises an electromagnetic sensor.
The guidewire of any of Examples 9 through 10, wherein the electromagnetic sensor comprises an electrically conductive coil.
The guidewire of any of Examples 9 through 11, wherein the navigation sensor is arranged distal to the inflatable element.
The guidewire of any Examples 9 through 12, wherein the navigation sensor is isolated from the lumen.
The guidewire of any of Examples 9 through 13, wherein the lumen terminates at a distal wall, wherein the navigation sensor is located distal to the distal wall, wherein the guidewire further comprises a sensor wire that extends through the lumen and the distal wall and is coupled to the navigation sensor, wherein the sensor wire is configured to communicate the signal generated by the navigation sensor.
A surgical navigation system comprising: (a) the guidewire of any of Examples 9 through 14; and (b) a processor in communication with the navigation sensor, wherein the processor is operable to receive and analyze the signal generated by the navigation sensor to determine the location of the distal end of the guidewire within the patient.
A guidewire comprising: (a) a guidewire shaft, wherein the guidewire shaft includes a lumen; (b) an inflatable element arranged at a distal portion of the guidewire shaft, wherein an interior of the inflatable element fluidly communicates with the lumen, wherein the inflatable element is operable to transition between a deflated state in which the inflatable element is configured to pass through an isthmus of a Eustachian tube (ET), and an inflated state in which the inflatable element is configured to dilate the ET; and (c) a navigation sensor, wherein the navigation sensor is operable to generate a signal corresponding to a location of a distal end of the guidewire within a patient.
The guidewire of Example 16, wherein the navigation sensor comprises an electrically conductive coil.
The guidewire of any of Examples 16 through 17, wherein the navigation sensor is arranged distal to a proximal end of the inflatable element.
A guidewire comprising: (a) a guidewire shaft, wherein at least a portion of the guidewire shaft is comprised of metal; and (b) an expandable element arranged at a distal portion of the guidewire shaft, wherein the expandable element is operable to transition between an unexpanded state in which the expandable element is configured to pass through an isthmus of a Eustachian tube (ET), and an expanded state in which the expandable element is configured to dilate the ET, wherein the guidewire is configured to assume a maximum outer diameter of 1 millimeter or less when the expandable element is in the unexpanded state.
The guidewire of Example 19, wherein the expandable element is configured to provide the guidewire with a maximum outer diameter of at least 6 millimeters when the expandable element is in the expanded state.
IV. Miscellaneous
It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein. The above-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those skilled in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures. By way of example only, various teachings herein may be readily incorporated into a robotic surgical system such as the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, Calif.
Versions of the devices described above may 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, some 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, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a user immediately prior to a procedure. Those skilled in the art will appreciate that 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.
By way of example only, versions described herein may be sterilized before and/or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device 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 device and in the container. The sterilized device may then be stored in the sterile container for later use. 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, or steam.
Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16015293 | Jun 2018 | US |
| Child | 17306998 | US |
