阅读说明：本技术 具有深度标记的咽鼓管扩张导管 (Eustachian tube dilating catheter with depth mark ) 是由 F·阿克巴里安 J·帕鲁什 于 2020-03-20 设计创作，主要内容包括：本发明提供一种用于将导丝定位在解剖通道内的外科系统和方法,该外科系统包括导丝(300)、扩张器(308)、参考特征部(317)和标记物(602,604)。该导丝具有导丝主体,该导丝主体延伸到远侧主体端部部分。该扩张器固定在该远侧主体端部部分上并且被配置成从收缩状态膨胀到膨胀状态。处于该收缩状态的该扩张器被配置成穿过咽鼓管(26)的峡部(29)。处于该膨胀状态的该扩张器被配置成扩张该咽鼓管。该参考特征部相对于该导丝固定,并且该标记物与该参考特征部相距预定距离定位在该导丝上。因此,该标记物被配置成向操作者指示该预定距离以用于确定该参考特征部在该解剖通道中的深度。(A surgical system and method for positioning a guidewire within an anatomical passageway is provided, the surgical system including a guidewire (300), a dilator (308), a reference feature (317), and a marker (602, 604). The guidewire has a guidewire body that extends to a distal body end portion. The dilator is secured to the distal body end portion and is configured to expand from a collapsed state to an expanded state. The dilator in the collapsed state is configured to pass through an isthmus (29) of a eustachian tube (26). The dilator in the expanded state is configured to dilate the eustachian tube. The reference feature is fixed relative to the guidewire, and the marker is positioned on the guidewire a predetermined distance from the reference feature. Thus, the marker is configured to indicate the predetermined distance to an operator for determining a depth of the reference feature in the anatomical passageway.)

1. A surgical system, comprising:

(a) a guidewire comprising a guidewire body extending to a distal body end portion thereof;

(b) a dilator secured over the distal body end portion and configured to expand from a collapsed state to an expanded state, wherein the dilator in the collapsed state is configured to pass through an isthmus of a eustachian tube, and wherein the dilator in the expanded state is configured to dilate the eustachian tube;

(c) a reference feature fixed relative to the guidewire; and

(d) a first marker positioned on the guidewire a first predetermined distance from the reference feature and configured to indicate the first predetermined distance to an operator for determining a depth of the reference feature in an anatomical passageway.

2. The surgical system of claim 1, wherein the reference feature is a portion of the dilator.

3. The surgical system of claim 2, wherein the portion of the dilator is a proximal end of the dilator.

4. The surgical system of claim 1, wherein the first marker is positioned on the guidewire body of the guidewire.

5. The surgical system of claim 4, wherein the guidewire body has an outer surface and the first marker is positioned on the outer surface.

6. The surgical system of claim 5, wherein the first marker is a first etched marker on the outer surface.

7. The surgical system of claim 1, wherein the reference feature is positioned distally relative to the first marker at the first predetermined distance.

8. The surgical system of claim 1, further comprising a second marker positioned on the guidewire a second predetermined distance from the reference feature and configured to indicate the second predetermined distance to the operator for further determining the depth of the reference feature in the anatomical passageway.

9. The surgical system of claim 8, wherein the reference feature is positioned distally relative to the first marker at the first predetermined distance, and wherein the reference feature is positioned distally relative to the second marker at the second predetermined distance.

10. The surgical system of claim 9, wherein the second predetermined distance is greater than the first predetermined distance.

11. The surgical system of claim 1, wherein the distal body end portion has a closed distal tip.

12. The surgical system of claim 1, wherein the guidewire with the dilator in the collapsed state radially defines a collapsed diameter about the guidewire body, and wherein the collapsed diameter is less than or equal to one millimeter.

13. The surgical system of claim 1, wherein the guidewire with the dilator in the expanded state radially defines an expanded diameter about the guidewire body, and wherein the expanded diameter is less than or equal to six millimeters.

14. The surgical system of claim 1, further comprising a navigation sensor fixed relative to the guidewire and configured to generate a signal to be detected by a navigation system for determining a position of the navigation sensor within a patient's body.

15. The surgical system of claim 14, further comprising a processor in communication with the navigation sensor, wherein the processor is configured to receive the signal generated by the navigation sensor and determine a location of the navigation sensor within the patient.

16. A guidewire, comprising:

(a) a guidewire body having an outer surface and extending to a distal body end portion thereof, wherein the distal body end portion has a closed distal tip;

(b) a dilator secured over the distal body end portion and configured to expand from a collapsed state to an expanded state, wherein the dilator in the collapsed state is configured to pass through an isthmus of a eustachian tube, and wherein the dilator in the expanded state is configured to dilate the eustachian tube;

(c) a reference feature fixed relative to the guidewire body; and

(d) a first marker positioned proximally on the outer surface of the guidewire body a first predetermined distance from the reference feature and configured to indicate the first predetermined distance to an operator for determining a depth of the reference feature in an anatomical passageway.

17. The guidewire of claim 16, further comprising a second marker positioned proximally on the outer surface of the guidewire a second predetermined distance from the reference feature structure and configured to indicate the second predetermined distance to the operator for further determining the depth of the reference feature in the anatomical passageway.

18. The guidewire of claim 17, wherein said second predetermined distance is greater than said first predetermined distance.

19. A method of positioning a guidewire within an anatomical passageway includes observing a marker on a guidewire body of the guidewire within the anatomical passageway, thereby identifying a location of a dilator secured over the guidewire within the anatomical passageway.

20. The method of claim 19, wherein the anatomical passageway is a eustachian tube, and the method further comprises inserting the dilator to a target location along the eustachian tube based on the observed marker.

Background

As shown in fig. 1, the ear (10) is divided into three parts: an outer ear (12), a middle ear (14) and an inner ear (16). The outer ear (12) consists of an auricle (18) and an ear canal (20), which collects sound and directs it to the tympanic membrane (22) (also referred to as eardrum) at the inner end (24) of the ear canal (20). The middle ear (14) is located between the outer and inner ears (12,16) and is connected to the back of the throat by a Eustachian Tube (ET) (26) which acts as a pressure equalization valve between the ear (10) and the sinuses. ET (26) terminates in a pharyngeal ostium (28) in a nasopharyngeal region (30) of the throat (32). In addition to the eardrum (22), the middle ear (14) is composed of three small ear bones (auditory ossicles): malleus (34) (hammer), incus (36) (navil), and stapes (38) (stinrup).

ET (26) is a narrow channel connecting the middle ear (14) and the nasopharynx (30). The ET (26) acts as a pressure equalization valve for the middle ear (14) which is normally filled with air. When functioning normally, the ET (26) is periodically opened for a fraction of a second in response to swallowing or yawning. In this way, it allows air to enter the middle ear (14) to replace air that has been absorbed by the middle ear lining (mucosa) or to balance pressure changes that occur at the time of height changes. Anything that interferes with this periodic opening and closing of the ET (26) can cause hearing loss or other ear symptoms. Occlusion or clogging of the ET (26) results in negative middle ear (14) pressure, with retraction (inhalation) of the eardrum (22). This may often be accompanied by some ear discomfort such as fullness or pressure and may result in slight hearing impairment and head noise (tinnitus). If the occlusion time is extended, the middle ear (14) may eventually become infected.

Methods of treating the middle ear (14) and ET (26) include those disclosed in the following patent applications: U.S. patent publication No. 2010/0274188 (now withdrawn), entitled "Method and System for Treating Target Tissue with the ET", published on 28/10/2010, the disclosure of which is incorporated herein by reference; U.S. patent publication No. 2013/0274715 (now withdrawn) entitled "Method and System for the european Tube translation" published on day 17, 10/2013, the disclosure of which is incorporated herein by reference; and U.S. patent No. 10,350,396 entitled "Vent Cap for a european pipe dimension System," issued on 16.7.2019, the disclosure of which is incorporated herein by reference. As described in these references, the function of the ET (26) can be improved by dilating the ET (26) with an inflatable dilator instrument.

While various 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.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with a general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the invention.

FIG. 1 shows a cross-sectional view of a patient's head showing the inner, middle and outer ear portions and the eustachian tube connecting the middle ear with the nasopharyngeal area of the throat;

FIG. 2 shows a perspective view of an exemplary guidewire with an inflatable balloon and a navigation sensor;

FIG. 3 shows a side elevation view of the guidewire of FIG. 2, schematically illustrating the internal inflation lumen and sensor wire of the guidewire;

FIG. 4 shows a schematic perspective view of an exemplary surgical navigation system incorporating the guidewire of FIG. 2;

FIG. 5A shows a cross-sectional view of a patient's head showing a distal portion of the guidewire of FIG. 2 positioned within a patient's eustachian tube via the middle ear; and is

Fig. 5B shows a cross-sectional view of the patient's head similar to fig. 5A, but showing the balloon of the guidewire inflated to dilate the eustachian tube.

The figures 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 shown in the figures. 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 should be understood, however, that the invention is not limited to the precise arrangements shown.

Detailed Description

The following description of certain examples of the invention should not be used to limit the scope of the 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 given 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 description are to be regarded as illustrative in nature and not as restrictive.

For clarity of disclosure, the terms "proximal" and "distal" are defined herein with respect to a surgeon or other operator holding a surgical instrument having a distal surgical end effector. The term "proximal" refers to a position where an element is disposed closer to a surgeon, and the term "distal" refers to a position where an element is disposed closer to a surgical end effector of a surgical instrument and further from a surgeon. Furthermore, to the extent that spatial terminology is used herein with reference to the accompanying drawings, it is understood that such terminology is used for the purpose of exemplary description only and is not intended to be limiting or absolute. In this regard, it should 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 term "about" with respect to any numerical value or range of numbers indicates a suitable dimensional tolerance that allows a portion or collection of multiple components to perform its intended purpose as described herein.

I. Exemplary instruments for dilating a eustachian tube via the middle ear and associated surgical navigation systems

With respect to fig. 1, one example of a treatment that may be performed to treat ET (26) that does not provide adequate communication between the middle ear (14) and the pharyngeal opening (28) includes: ET (26) is accessed and expanded using a guide catheter and a balloon dilation catheter. However, in the case of a guide catheter that cannot use a balloon dilation catheter, a device that includes a guidewire may be suitable. In other cases, it may be difficult or impossible to access the ET (26) by inserting the instrument through the nostrils, into the nasal cavity, and through the pharyngeal opening. This may be due to the patient's anatomical constraints or, in some cases, due to limitations of the skill set of a particular practitioner. Thus, in some cases, it may be more efficient to enter the ET (26) through the tympanic membrane (22) and the middle ear (14). However, due to the sensitive nature of the tympanic membrane (22) and middle ear structures, it may be advantageous to access the ET (26) in a manner that preserves ET (26) integrity or minimizes trauma to the ET (26). Furthermore, since this approach to ET (26) requires the practitioner to guide the instrument through the isthmus (29), care must be taken because of the small size and sensitivity of the isthmus (29) and the adjacent structure of the inner ear (16).

One example of a dilation instrument, such as the exemplary guidewire (300) described below with reference to fig. 2, 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) after positioning.

A. Exemplary inflatable guidewire with marker

Fig. 2 illustrates a guidewire (300) sized and configured to be passed through the tympanic membrane (22), the middle ear (14), and the isthmus (29) into the ET (26). The guidewire (300) includes an elongate tubular body (302) having a distal end portion (304) and a closed atraumatic distal tip (306) disposed at the distal end portion (304). The atraumatic tip (306) of the present example is generally circular in shape and sized to fit through the isthmus (29) and into the ET (26), as described in more detail below.

The guidewire body (302) of the present example is suitably configured to have a degree of lateral flexibility and column strength (i.e., stiffness) sufficient to enable the guidewire (300) to elastically conform to a tortuous internal path extending between the middle ear (14) and the ET (26) of a patient without buckling or otherwise plastically deforming, and without the need for an external guiding device, such as a guiding catheter (not shown). For example, at least a portion of the body 302 may be formed of braided stainless steel. In other examples, at least a portion of the body (302) may be configured with an outer coil (not shown) and an inner core wire (not shown). In various examples, the Guidewire body (302) may be formed of one or more metallic materials such as 316 stainless steel, titanium, cobalt chromium alloy, nitinol, MP35N steel alloy, or various other suitable materials as disclosed in U.S. patent No. 10,463,242 entitled "guide wire Navigation for sindisplay" issued 11/5 of 2019, the disclosure of which is incorporated herein by reference.

The guidewire (300) of the present example also includes an inflatable dilator in the form of an inflatable balloon (308) secured to an exterior of the guidewire body (302) proximal to the distal tip (306). The balloon (308) may be compliant, semi-compliant, or non-compliant in construction, and may be formed from any suitable polymeric material, such as polyethylene terephthalate (PET),(polyether block amide), nylon, etc.). The balloon (308) of the present example is suitably sized and configured to provide the guidewire (300) with a maximum outer diameter of less than or equal to about 1 millimeter when the balloon (308) is deflated, as shown in fig. 5A, and when the balloon (308) is fully inflatedProviding a maximum outer diameter of about 6 millimeters or more as shown in fig. 2-3 and 5B. In at least some applications, a maximum outer diameter of about 6 millimeters provides sufficient expansion of the patient ET (26) during the ET expansion procedure. However, it should be understood that the balloon (308) may be suitably configured to exhibit other maximum sizes for other applications and expansion procedures. The balloon (308) of the present example may have a working length of about 12 millimeters to about 24 millimeters. In other examples, the balloon (308) may have a working length of about 20 millimeters to about 40 millimeters.

As best shown in fig. 3, the internal inflation lumen (310) extends longitudinally through the guidewire body (302) along a central longitudinal axis of the body (302). A proximal end portion (not shown) of the inflation lumen (310) is in fluid communication with a source of inflation medium (not shown). A distal end of the inflation lumen (310) is in fluid communication with an interior of the balloon (308) via a plurality of apertures (312) extending laterally through a sidewall of the guidewire body (302). While the guidewire body (302) of the present example includes four apertures (312) generally aligned with the middle portion of the balloon (308), any suitable number and arrangement of apertures (312) may be provided in other examples. The inflation lumen (310) terminates at a distal wall (314) distal to the distal-most aperture (312) and proximal to a distal end (313) of the balloon (308). The inflation lumen (310) is configured to deliver a pressurizing medium (e.g., saline) to and from an interior of the balloon (308) in response to user input to enable selective inflation and deflation during an expansion procedure, such as described in one example described below with reference to fig. 5A-5B.

Although not shown, the guidewire (300) may be actuated with any suitable type of actuation device that may be held and operated by a user and that may have features similar to those disclosed in U.S. patent publication No. 2019/0015645 entitled "Adjustable Instrument for diagnosis of atomic passage way", published on day 17, 1 month 2019, the disclosure of which is incorporated herein by reference.

The guidewire (300) of the present example shown in fig. 3 further includes a navigation sensor (316) (shown schematically) disposed at the distal end portion (304) proximal to the distal tip (306) and distal to the distal end (313) of the balloon (308). The navigation sensor (316) is operable to generate a signal corresponding to a position of the distal end portion (304) within the patient during the surgical procedure, and thus enable the surgeon to track the position of the distal end portion (304) within the patient in real-time, as described in more detail below. The navigation sensor (316) may be in the form of a conductive coil (not shown) configured to generate an electrical signal when placed within an externally generated magnetic field, as described below.

As shown in fig. 3, the guidewire (300) houses a pair of sensor wires (318) coupled to the navigation sensor (316) and extending proximally through the distal lumen wall (314) and inflation lumen (310) toward a proximal end portion (not shown) of the guidewire (300). The location where the sensor wire (318) extends through the distal lumen wall (314) may be sealed with an adhesive (not shown) or other material suitable for preventing entry of inflation fluid from the lumen (310) toward the navigation sensor (316). Thus, the navigation sensor (316) is fluidly isolated from the inflation lumen (310). The sensor wire (318) is configured to transmit the electrical signal from the navigation sensor (316) to a processor of a navigation system, such as the processor (408) of the surgical navigation system (401) described below (see fig. 4). Although only one navigation sensor (316) is shown, in other examples, two or more navigation sensors may be provided at various locations within the guidewire (300), for example to track the position and rotational orientation of the distal end portion (304) of the guidewire (300) within the patient. However, it should be understood that the navigation sensor (316) is only optional, and may be omitted entirely from the guidewire (300) and sensor wire (318) in some examples. In such examples, the guidewire (300) may be navigated through the anatomical passageway of the patient with the aid of various other suitable guiding devices and methods (those apparent to those skilled in the art) disclosed below, or without any such guiding device.

The guidewire (300) further comprises a marker pattern (600) comprising: one or more markers (602,604) proximate a distal end portion (304) of the guidewire (300), such as near a proximal end (317) of the balloon (308); and one or more spacers (606,608) for spacing the markers (602, 604). In this example, such markers (602,604) are depth markers configured to visually indicate the distance that a reference feature, such as a proximal end (317) of a balloon (308), is located within a desired anatomy of a patient. Such reference features are secured to the body (302) a predetermined distance from each such marker (602,604), respectively. Thus, the markers (602,604) are positioned at a fixed longitudinal distance from a reference feature, in this example, more specifically, the proximal end (317) of the balloon (308). The markers (602,604) shown in this example are etched directly onto the outer surface (319) of the body (302), such as by a laser, but alternative markers (not shown) may be positioned on the body (302) by other known methods, such as fasteners or painting.

Markers (602,604) are positioned and examined under endoscopic vision as the guidewire (300) is advanced through an anatomical passageway, such as within an ear (10) (see fig. 5A), to determine the advancement distance of the guidewire (300) within the anatomical passageway with high accuracy. The markers (602,604) may be visible under a microscope, endoscopic view, or in any other suitable manner. The use of a pattern of one or more markers (602,604) may also indicate the distance of the guidewire (300) within the anatomical passageway, such as one marker (602,604) at one centimeter within the lumen, two markers (602,604) at two centimeters within the lumen, and so on. Alternatively, one marker (602,604) may be located on the guidewire (300) at each centimeter increment from the proximal end of the balloon (308). Of course, the markers (602,604) may be located at any known location on the body (302) of the guidewire (300) relative to any predetermined reference feature, such that the invention is not intended to be unnecessarily limited to the specific markers (602,604) and septa (606,608) shown and described herein. Thus, any distance unit suitable for the application may be used, and any number of markers (602,604) may be located on the guidewire (300).

B. Exemplary surgical navigation System incorporating guidewire with marker

Fig. 4 shows an exemplary surgical system (400) that enables an ENT procedure to be performed using image guidance in conjunction with a guidewire (300) and an exemplary IGS navigation system (401). When performing a medical procedure within the head (H) of a patient (P), it may be desirable to obtain information about the position of the instrument within the head (H) of the patient (P), in particular when the instrument is in a position where it is difficult or impossible to obtain an endoscopic view of the working elements of the instrument within the head (H) of the patient (P). In addition to, or instead of, having the components and operability described herein, the IGS navigation system (401) may be constructed and operated in accordance with at least some of the teachings of the following patents: U.S. Pat. No. 7,720,521 entitled "Methods and Devices for Performing products with the Ear, Nose, Throat and Manual Sinues", published on day 5, month 18 of 2010, the disclosure of which is incorporated herein by reference; and U.S. patent publication 2014/0364725 (now withdrawn) entitled "Systems and Methods for Performing Image Guided Procedures in the Ear, Nose, thread and commercial countries," published 11/12/2014, the disclosure of which is incorporated herein by reference.

The IGS navigation system (401) of the present example includes a field generator assembly (402) comprising a set of magnetic field generators (406) integrated into a horseshoe-shaped frame (404). The field generator (406) is operable to generate alternating magnetic fields of different frequencies around the head (H) of the patient (P). The navigation guidewire (300) is inserted into the head (H) of the patient (P). In this example, the frame (404) is mounted to a chair (430), with the patient (P) seated in the chair (430) such that the frame (404) is located near the head (H) of the patient (P). By way of example only, the seat (430) and/or the Field generator assembly (402) may be constructed and operated in accordance with at least some of the teachings of U.S. publication No. 2018/0310886 entitled "Apparatus to Secure Field generating device to Chair," published on 11/1/2018, the disclosure of which is incorporated herein by reference.

The IGS navigation system (401) of the present example also includes a processor (408) that controls the field generators (406) and other elements of the IGS navigation system (401). For example, the processor (408) is operable to drive the field generator (406) to generate an alternating electromagnetic field; and processing signals from the navigation guidewire (300) to determine the position of the sensor (316) (see fig. 2) in the guidewire (300) within the head (H) of the patient (P). The processor (408) includes a processing unit (not shown) in communication with one or more memories (not shown). The processor (408) of the present example is mounted in a console (410) that includes operational controls (412) including a keyboard and/or a pointing device, such as a mouse or a trackball. An operator, such as a physician, interacts with the processor (408) using the operator controls (412) while performing a surgical procedure.

The guidewire (300) includes a sensor (316) positioned responsive to the alternating magnetic field generated by the field generator (406) (see fig. 2). A communication unit (416) is secured to the proximal end of the guidewire (300) and is configured to provide communication of data and other signals between the console (410) and the guidewire (300). The communication unit (416) may provide wired or wireless communication of data and other signals.

In this example, the sensor (316) (see fig. 2) of the guidewire (300) includes at least one coil (not shown) located at the distal end of the navigation guidewire (14). When such a coil (not shown) is positioned within the alternating electromagnetic field generated by the field generator (406), the alternating magnetic field may generate a current in the coil (not shown), and this current may be transmitted along the wire (318) in the guide wire (300) (see fig. 3) and further to the processor (408) via the communication unit (416). This phenomenon may enable the IGS navigation system (401) to determine the position of the distal end portion (304) (see fig. 2) of the guidewire (300) or other medical instrument (e.g., dilation instrument, surgical cutting instrument, etc.) within three-dimensional space (i.e., within the head (H) of the patient (P), etc.). To accomplish this, the processor (408) executes an algorithm to calculate position coordinates of the distal end portion (304) of the guidewire (300) from position-related signals of a coil (not shown) in the guidewire (300). Although the sensor (316) (see fig. 2) is located in the guidewire (300) in this example, such sensors may be integrated into various other kinds of instruments.

The processor (408) calibrates and operates the IGS navigation system (401) using software stored in a memory (not shown) of the processor (408). Such operations include driving the field generator (406), processing data from the guidewire (300), processing data from the operational controls (412), and driving the display screen (414). In some implementations, the operations may also include monitoring and enforcing one or more security features or functions of the IGS navigation system (401). The processor (408) is further operable to provide video in real-time via a display screen (414) showing a position of the distal end portion (304) (see fig. 2) of the guidewire (300) relative to a camera image of the patient's head (H), a CT scan image of the patient's head (H), and/or a computer-generated three-dimensional model of an anatomical structure within and near the patient's nasal cavity. The display screen (414) may display such images simultaneously and/or superimposed on each other during a surgical procedure. Such display images may also include graphical representations of instruments inserted into the patient's head (H), such as a navigation guidewire (14), so that the operator can view in real time a virtual rendering of the instrument at its actual location. By way of example only, the display (414) may provide images in accordance with at least some of the teachings of U.S. patent No. 10,463,242 entitled "guide wire Navigation for sindisplay," published on day 5, 11/2019, the disclosure of which is incorporated herein by reference. In the case where the operator also uses an endoscope, an endoscopic image may also be provided on the display screen (414).

When the instrument incorporates a guide wire (300), the images provided by the display screen (414) may help guide the operator to steer and otherwise manipulate such instruments within the patient's head (H). It should also be understood that other components of the surgical instrument, as described below, and other types of surgical instruments, may incorporate sensors, such as the sensor (316) of the guide wire (300) (see fig. 2).

C. Exemplary methods of dilating a eustachian tube using a guidewire with a marker

Fig. 5A-5B illustrate an exemplary method of dilating a patient's ET (26) using the guidewire (300) described above. The method shown in fig. 5A-5B involves entering the ET (26) through the ear canal (20) and tympanic membrane (22) rather than inserting a guide wire (300) through the nostril into the nasal cavity and through the pharyngeal opening (28). In the present example shown in fig. 5A, the guidewire (300) is advanced through the ear canal (20) and navigated through the internal passage of the patient's head using real-time guidance provided by the navigation sensor (316) and IGS navigation system (401), as described above. A guidewire (300) is shown extending from a proximal shaft (390) disposed in the ear canal (20). Some variations may omit the proximal shaft (390), such as a guidewire (300) with a balloon (308) extending into the ear canal (20) without a shaft (390). Also as described above, the navigation sensor (316) is only optional. Thus, in other examples, the guidewire (300) may be used to enter and dilate the ET (26) using alternative types of guidance features, such as an endoscope or illumination fibers (not shown), or even without using any such guidance features.

One of ordinary skill in the art will recognize that the tympanic membrane (22) provides a physical barrier for the transfer of an instrument, such as a balloon catheter, from the ear canal (20) into the ET (26). Therefore, the operator must somehow address the presence of the tympanic membrane (22) in order to access the ET (26) from the ear canal (20). One such exemplary Method of properly inserting a guidewire (300) through the tympanic membrane (22) into the ET (26) via the Ear canal (20) is disclosed in U.S. patent No. 10,070,993 entitled "System and Method for Treatment of a Eustachian Tube from Middle Ear apparatus" issued on 11.9.2018, the disclosure of which is incorporated herein by reference.

The operator continues to insert the balloon (308) distally beyond the middle ear (14) and ET (26) without compromising the integrity of the tympanic membrane (22). In this example, an endoscope (60) is inserted into the middle ear (14) along the side of the guidewire (300) to provide visualization of the guidewire (300) positioned in the isthmus (29). Additional teachings associated with placement of an endoscope (60) in the Middle Ear (14) are disclosed in U.S. patent publication No. 2019/0388661 entitled "guiding wire for scaling Eustachian Tube Via Middle Ear," published on 26.12.2019, the disclosure of which is incorporated herein by reference.

An operator advances the balloon (308) distally into the ET (26) toward the target location to inflate the balloon (308) from the contact state to the inflated state, thereby expanding the ET (26). To more accurately and precisely position the balloon (308) at the target location, the operator simultaneously views a visualization of the markers (602,604) relative to the isthmus (29) or other adjacent reference anatomy. In one example, with each marker (602,604) positioned proximally from balloon (308) (indicating an additional respective centimeter from balloon (308)), the operator counts the number of times each marker (602,604) exceeds isthmus (29). The operator then determines the distance between the last visible marker (602,604) located proximally relative to the isthmus (29) and the proximal end (317) of the balloon (308), which is the reference feature in this example. The operator can count the number of times one marker (602), one centimeter from the proximal end (317) of the balloon (308), is distal beyond the isthmus (29), while another marker (604), two centimeters from the proximal end (317) of the balloon (308), remains visible adjacent the isthmus (29). The operator can then determine that the proximal end (317) of the balloon (308) is about two centimeters from the isthmus (29) without directly viewing the proximal end (317) of the balloon (308). In other examples, the operator may make a similar determination based on a particular pattern on the markers (602, 604).

Further, in one example, with further reference to fig. 3 and 4, the operator may view the display (414) to determine the position of the sensor (316) on the guidewire (300) while also viewing the visualization of the markers (602,604) described above. Such observation may be beneficial for positioning the distal end portion (304) of the guidewire (300) on the display (414) while identifying the proximal end (317) of the balloon (308) in the ET (29) for confirming the location of the balloon (308) in the ET (29) to more accurately and precisely position the balloon (308) at a desired target location. In any case, once in the target position within ET (ET), the operator expands the balloon (308) from the deflated state shown in fig. 5A to the inflated state shown in fig. 5B, thereby expanding the ET. Once inflated, the operator may return the balloon (308) to the deflated state for removal or repositioning for another expansion, as desired. Such repositioning may again be performed based on visualization of the markers (602,604) and/or the display (414).

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 limit the scope of coverage of any claims that may be presented at any time in this patent application or in subsequent filing of this patent application. Disclaimer is not intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following embodiments. Thus, none of the aspects or features mentioned below should be considered critical unless explicitly indicated otherwise, e.g., by the inventors or successors to the inventors at a later date. If any claim made in this patent application or in a subsequent filing document related to this patent application includes additional features beyond those mentioned below, then these additional features should not be assumed to be added for any reason related to patentability.

Example 1

A surgical system, comprising: (a) a guidewire comprising a guidewire body extending to a distal body end portion thereof; (b) a dilator secured over the distal body end portion and configured to expand from a collapsed state to an expanded state, wherein the dilator in the collapsed state is configured to pass through an isthmus of a eustachian tube, and wherein the dilator in the expanded state is configured to dilate the eustachian tube; (c) a reference feature fixed relative to the guidewire; and (d) a first marker positioned on the guidewire at a first predetermined distance from the reference feature and configured to indicate the first predetermined distance to an operator for determining a depth of the reference feature in an anatomical passageway.

Example 2

The surgical system of embodiment 1, wherein the reference feature is a portion of the dilator.

Example 3

The surgical system of embodiment 2, wherein the portion of the dilator is a proximal end of the dilator.

Example 4

The surgical system of any one or more of embodiments 1-3, wherein the first marker is positioned on the guidewire body of the guidewire.

Example 5

The surgical system of embodiment 4, wherein the guidewire body has an outer surface and the first marker is positioned on the outer surface.

Example 6

The surgical system of embodiment 5, wherein the first marker is a first etched marker on the outer surface.

Example 7

The surgical system of any one or more of embodiments 1-6, wherein the reference feature is positioned distally relative to the first marker at the first predetermined distance.

Example 8

The surgical system of any one or more of embodiments 1-7, further comprising a second marker positioned on the guidewire a second predetermined distance from the reference feature and configured to indicate the second predetermined distance to the operator for further determining a depth of the reference feature in the anatomical passageway.

Example 9

The surgical system of embodiment 8, wherein the reference feature is positioned distally relative to the first marker at the first predetermined distance, and wherein the reference feature is positioned distally relative to the second marker at the second predetermined distance.

Example 10

The surgical system of embodiment 9, wherein the second predetermined distance is greater than the first predetermined distance.

Example 11

The surgical system of any one or more of embodiments 1-10, wherein the distal body end portion has a closed distal tip.

Example 12

The surgical system of any one or more of embodiments 1-11, wherein the guidewire with the dilator in the collapsed state radially defines a collapsed diameter about the guidewire body, and wherein the collapsed diameter is less than or equal to one millimeter.

Example 13

The surgical system of any one or more of embodiments 1-12, wherein the guidewire with the dilator in the expanded state radially defines an expanded diameter about the guidewire body, and wherein the expanded diameter is less than or equal to six millimeters.

Example 14

The surgical system of any one or more of embodiments 1-13, further comprising a navigation sensor fixed relative to the guidewire and configured to generate a signal to be detected by the navigation system for determining a position of the navigation sensor within the patient.

Example 15

The surgical system of embodiment 14, further comprising a processor in communication with the navigation sensor, wherein the processor is configured to receive the signal generated by the navigation sensor and determine the position of the navigation sensor within the patient.

Example 16

A guidewire, comprising: (a) a guidewire body having an outer surface and extending to a distal body end portion thereof, wherein the distal body end portion has a closed distal tip; (b) a dilator secured over the distal body end portion and configured to expand from a collapsed state to an expanded state, wherein the dilator in the collapsed state is configured to pass through an isthmus of a eustachian tube, and wherein the dilator in the expanded state is configured to dilate the eustachian tube; (c) a reference feature fixed relative to the guidewire body; and (d) a first marker positioned proximally from the reference feature on the outer surface of the guidewire body a first predetermined distance and configured to indicate the first predetermined distance to an operator for determining a depth of the reference feature in an anatomical passageway.

Example 17

The guidewire of embodiment 16, further comprising a second marker positioned proximally a second predetermined distance from the reference feature structure on the outer surface of the guidewire and configured to indicate the second predetermined distance to the operator for further determining a depth of the reference feature in the anatomical passageway.

Example 18

The guidewire of embodiment 17, wherein the second predetermined distance is greater than the first predetermined distance.

Example 19

A method of positioning a guidewire within an anatomical passageway, the method comprising observing a marker on a guidewire body of the guidewire within the anatomical passageway, thereby identifying a location of a dilator secured over the guidewire within the anatomical passageway.

Example 20

The method of embodiment 19, wherein the anatomical passageway is a eustachian tube, and the method further comprises inserting the dilator to a target location along the eustachian tube based on the observed marker.

Miscellaneous items

It is to 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. described herein. Accordingly, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from each other. Various suitable ways in which the teachings herein may be combined will be 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 understood that any patent, 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. Thus, 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 above described apparatus may be used in traditional medical treatments and procedures performed by medical professionals, as well as in robotic-assisted medical treatments and procedures. By way of example only, the various teachings herein may be readily incorporated into a robotic Surgical system, such as davinc (r) of intelligent Surgical, Inc (Sunnyvale, California)^TMProvided is a system.

Devices of the type described above may be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either or both cases, these versions can be reconditioned for reuse after at least one use. The repair may include any combination of the following steps: disassembly of the device, followed by cleaning or replacement of particular parts 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 components, 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 can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques and the resulting prosthetic devices are within the scope of the present application.

By way of example only, versions described herein may be sterilized before and/or after surgery. 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 a sterile container for later use. The 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.

While various embodiments of the present invention have been shown and described, further modifications 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 such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, implementations, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not required. The scope of the invention should, therefore, 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.