Endoscope with navigation capability

Abstract

Various embodiments disclosed relate to a catheter system. A device may include a catheter with a shaft having a proximal end and a distal end, the catheter configured to extend distally towards a target site. A device may include at least one navigation sensor integrated with the shaft, wherein the at least one navigation sensor is actuatable to provide a sensor response signal for navigation to the target site without requiring fluoroscopy or in vivo visualization. A device may include at least one response detector configured to determine a parameter value from the sensor response signal from the at least one navigation sensor. A device may include signal processing circuitry, coupled to the at least one response detector, the signal processing circuitry configured to analyze the parameter value and determine, from analysis of the parameter value, a location of the target site, and generate a location signal accordingly.

Description

ENDOSCOPE WITH NAVIGATION CAPABILITYPRIORITY CLAIM

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 601,841, filed November 22, 2023, the contents of which are incorporated herein.BACKGROUND

[0002] The present disclosure relates to a medical device. In a variety of medical procedures, many types of endoscopes are used to treat patients.

[0003] An operator, such as a physician, practitioner, or user, can use an endoscope to provide visual access to an internal location of a patient. The operator can insert an endoscope into a patient’s body. The endoscope can deliver light to a target being examined, such as a target anatomy or object. The endoscope can collect light that is reflected from the object. The reflected light can carry information about the target being examined.

[0004] An endoscope can include a working channel. The operator can perform suction through the working channel. The operator can pass instruments, such as brushes, biopsy needles or forceps, through the working channel. The operator can perform minimally invasive surgery through the working channel, such as to remove unwanted tissue or foreign objects from the body of the patient.

[0005] An endoscope can use a laser or plasma system to perform a variety of procedures, including, for example, illuminating, imaging, detecting and diagnosing one or more disease states, providing fluid delivery (e.g., saline or other preparations via a fluid channel) toward an anatomical region, providing passage (e.g., via a working channel) of one or more therapeutic devices for sampling or treating an anatomical region, and providing suction passageways for collecting fluids (e.g., saline or other preparations) and the like.

[0006] In conventional endoscopy, the distal portion of the endoscope can be configured for supporting and orienting a therapeutic device, such as with the use of an elevator. In some systems, two endoscopes can be configured to work together with a first endoscope guiding a second endoscope inserted therein with the aid of the elevator. Such systems can be helpful in guiding small-diameter endoscopes to anatomic locations within the body that are difficult to reach. For example, some anatomic locations can only be accessedwith an endoscope after insertion through a circuitous path. Furthermore, the tissue in some anatomic locations can be sensitive. As such, it can be undesirable to guide an endoscope to an unintended anatomic location.SUMMARY OF THE DISCLOSURE

[0007] In some aspects, the techniques described herein relate to a catheter system including: a catheter with a shaft having a proximal end and a distal end, the catheter configured to extend distally towards a target site; at least one navigation sensor integrated with the shaft, wherein the at least one navigation sensor is actuatable to provide a sensor response signal for navigation to the target site without requiring fluoroscopy or in vivo visualization; at least one response detector configured to determine a parameter value from the sensor response signal from the at least one navigation sensor; and signal processing circuitry, coupled to the at least one response detector, the signal processing circuitry configured to analyze the parameter value and determine, from analysis of the parameter value and a pre-produced map of the target site, and generate a location signal accordingly.

[0008] In some aspects, the techniques described herein relate to a method including: retrieving a three-dimensional map of a patient anatomical area, the three-dimensional map produced during a first operation at the patient anatomical area; generating a proposed navigation plan for a medical device in the patient anatomical area during a proposed second operation at the patient anatomical area; inserting the medical device in the patient area and navigating the medical device according to the proposed navigation plan; collecting navigation data in real time with one or more navigation components integrated with the medical device; and adjusting the navigation path in real time according to the collected navigation data.

[0009] In some aspects, the techniques described herein relate to a method of mapping a target area in a patient, the method including: inserting a medical device into the patient near the target area, the medical device including an optical navigation system having at an optical fiber bundle and at least one fiber Bragg grating thereon; directing sensing light distally along the optical fiber bundle such that at least a portion of the sensing light reflects from the fiber Bragg grating as reflected light; performing optical frequency domain reflectometry on the reflected light; and determining the location of the target area based on the optical frequency domain reflectometry.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0011] FIG. 1 illustrates surgical system in an example.

[0012] FIG. 2 illustrates an example suction catheter system having a navigation component.

[0013] FIG. 3 illustrates a lithotripsy device with navigation capability in an example.

[0014] FIG. 4 illustrates a schematic diagram of an endoscopy system with an imaging and control system and an endobronchial ultrasound sampling in an example.

[0015] FIG. 5 schematically illustrates imaging and control system components coupled to the endoscope of FIG. 4.

[0016] FIG. 6 is a schematic diagram of endoscopy system comprising imaging and control system and duodenoscope in an example.

[0017] FIG. 7 schematically illustrates components of imaging and control system coupled to duodenoscope of FIG. 6, which in the illustrated example comprises a duodenoscope.

[0018] FIG. 8 illustrates a flow chart a method of using a blind navigation technique in a surgical system in an example.

[0019] FIG. 9 illustrates a flow chart a method of using a blind navigation technique in a surgical system in an example.

[0020] FIG. 10 illustrates a flow chart a method of using a blind navigation technique in a surgical system in an example.

[0021] FIG.11 illustrates a flowchart of a method for mapping a target area in a patient in an example.

[0022] FIG. 12 is a flowchart of an example method of applying a mapped target area in a patient.

[0023] FIG. 13 illustrates a schematic diagram of an example of a computer-based clinical decision support system (CDSS) that is configured to determine whether a parameter value, such as a pressure value or a temperature value, satisfies a specified condition in an example.

[0024] FIG. 14 illustrates a block diagram of an example machine upon which any one or more of the techniques (e.g., methodologies) discussed herein may perform in an example.DETAILED DESCRIPTION

[0025] Discussed herein are a system and method of blind navigation for use with an endoscope system. The endoscope can be a deflectable endoscope with at least one navigation component that provides navigation without use of fluoroscopy. These navigation techniques can allow for improved navigation for both diagnostic and therapeutic techniques, such as allowing easier return to particular anatomical sites within a patient at a later time. The navigation techniques and coordinates discussed herein can be added to and use in patient history, such as in an electronic record available for provider review. A later provider can refer back to the navigation history, and leverage the technique for efficient return to such a treatment site. The ability to return to a location within the anatomy can help with reviewing a healing profile of a patient, such as checking scar tissue or regrowth, checking for patient deterioration at that site, or allowing for further treatment at that site. Providers can adjust patient treatment plans and care accordingly.

[0026] The navigation component can be, for example, an optical guidance system using a fiber Bragg grating, an electromagnetic coil, or both. In the first case, an optical fiber bundle can extend along the endoscope, and can have at least one fiber Bragg grating. Sensing and controller circuitry can run an optical signal down the fiber bundle, at least a portion of which can be reflected by the FBG. The reflected portion can be subject to optical frequency domain reflectometry, and based on this analysis, a location value can be calculated.

[0027] For example, in a surgical system, an endoscope can extend distally toward a target site. A sensing optical fiber, extending to a distal portion of the endoscope, can include a fiber Bragg grating disposed at a distal portion of the sensing optical fiber. A sensing controller can direct sensing light distally along the sensing optical fiber such that at least some of the sensing light reflects from the fiber Bragg grating as reflected light. The sensing controller can perform optical frequency domain reflectometry on the reflected light to determine a parameter value, such as a pressure value or a temperature value, at the fiber Bragg grating. Processing circuitry can analyze the parameter value to determine that aparameter, such as a location of the fiber Bragg grating. In some cases, the processing circuitry can generate an alert data signal and / or perform another task.

[0028] In the second case, an electromagnetic coil can be included in the endoscope, such as at the tip. Here, an electromagnetic generator can be used to produce rapidly changing magnetic fields outside the patient. The created electrical current can be monitored by the sensing and controller circuitry. The change in the fields can be used to calculate a location, such as in a Cartesian coordinate system.

[0029] Additional sensors can be used in conjunction with the fiber Bragg gratings and / or electromagnetic coils. For example, a particle detector, turbidity sensor, or pressure feedback element can be integrated to help increase precision of localization. A particle detector, for example, can be placed between the device and a fluid outlet to detect outgoing particles during suction or irrigation. A turbidity sensor can help determine if stone or tissue fragments are still being removed from the area. A pressure feedback element can help ensure appropriate pressure levels in the targeted anatomy.

[0030] The produced location, tied to a marker or ground zero such as a patient anatomy landmark or external tattoo, can be recorded in the patient’s medical history or charts. In the same procedure, with a second instrument, the marked location can be used to navigated back to that same target area. In some cases, this information can be used in a later procedure to navigation back to that target area.

[0031] The present disclosure describes, among other things, a suction catheter, such as for use in medical procedures, that has navigation capability. The suction catheter can be placed blindly without reliance on fluoroscopy, x-ray, or other irradiation imaging. The suction catheter can be used to produce a map of a patient target area that can then be referenced in later treatments for aid in positioning of one or more medical instruments.

[0032] During minimally invasive lithotripsy, stones are broken down through the use of an energy source and formed into fragments of a size that should be easily passed by the patient, through the urethra. However, these stones and dust particles are not always flushed through the body as desired, with stone fragments and dust, remaining in the kidney and there becoming nidus points for future stone growth. Similarly, in other medical procedures, such as gastrointestinal procedures or respiratory procedures, a particular patient anatomy site may be returned to at a later surgery, or be reviewed again at a later time.

[0033] This issue has been addressed to some extent by use of a catheter that is placed ‘blindly’ with the use of fluoroscopy for imaging. Such a device can suction out larger stoneparticles than is possible with a system burdened with other requirements such as illumination and optical data transfer. However, in these solutions, the patient is undesirably exposed to an increased amount of radiation as the fluoroscopic placement of the catheter is undertaken. At present, surgical procedure direction is moving away from extended periods of x-ray exposure, due to health concerns regarded with this means of visualization.

[0034] Thus, the devices and methods proposed herein allow for a change in the placement modality and technology used. In this case, a sheath can be ‘blindly’ placed with navigation that does not require fluoroscopy or other irradiation dependent imaging. This helps reduce the exposure of the patient and the operating room staff to the x-ray radiation.

[0035] The system discussed herein has a variety of advantages. The blind navigation component can allow for catheter or endoscope placement without relying on fluoroscopy or other irradiating imaging techniques. The combination of multiple navigation techniques (e.g., electromagnetic coils and optical systems like Fiber Bragg gratings) in a single device is also beneficial in that they provide a variety of cross-checking and precision elements to the navigation capabilities. This is bolstered by the incorporation of various sensors (particle detector, turbidity sensor, pressure feedback element).

[0036] The ability to store and recall previous treatment locations for precise repositioning in future procedures demonstrates a practical application. This feature is useful in long term patient care. Additionally, the reduction in radiation exposure for patients and medical staff through the use of blind navigation is a significant technological improvement over current fluoroscopy-based methods.

[0037] In another example, the techniques discussed herein can be used to track an internal structure of a patient as they’re growing. Thus, a provide can see how an anatomy is tending or growing over a time period, such as to track concerns. This can aid in treatment plans and predictions for a patient, such as allowing for the planning of corrective surgeries prior to a problem getting worse.

[0038] In some cases, the navigation technologies discussed herein can be used to probe different regions of a nodule, such as to affect different regions and treat, for example, a cancerous region as opposed to a particular point. In other words, the navigation techniques can be used to identify and map a macro location in the neighborhood of a particular features or health issue, such as a cancer region. In later treatment or diagnostic, the general region or area can be returned to much more quickly, and the collected navigation data can be used to more easily navigate around that area, as opposed to at a particular lesion site or treatmentsite. This can allow for more general treatment, treatment of multiple lesions, polyps, nodules, or other approaches that include multiple samples. This approach can be leveraged in both diagnostic and a treatment uses.

[0039] Collection of more objective data from such navigation techniques, over a period of time, can be used potentially for individual patient treatment, but possibly also leveraged in broader studies where applicable. For example, such information could be used in studies, throughout a hospital system, and potentially in studies, if / when approved for sharing under appropriate rules and laws.

[0040] The potential applications across multiple medical fields (e.g., urology, GI, ENT, respiratory) are also beneficial. The method of processing navigation data to create patient-specific “maps” for use across multiple procedures can provide highly precise positioning and repositioning. Moreover, the navigation system and techniques discussed herein have potential to work with existing medical devices and procedures (e.g., integrating with endoscopic navigation systems), as discussed below.

[0041] FIG. 1 illustrates surgical system 100 in an example. The surgical system 100 can be used, for example, in conjunction with a medical device having “blind” guiding or navigational components that do not include fluoroscopy or in vivo visualization. The configuration of FIG. 1 is but one example of a surgical system; other configurations can also be used.

[0042] The surgical system 100 can include an endoscope 102. The endoscope 102 can be an example surgical device for use in a variety of different medical procedures. More specific examples of endoscopes, such as for lithotripsy, vascular applications, respiratory treatment, or gastrointestinal procedures, are shown and discussed below with references to FIGS. 3 to 7 below. The endoscope 102 can be used with a the “blind” guiding elements such as fiber Bragg grating, magnetic coil components, or both, to help produce and use a mapping of target tissue for effective treatment.

[0043] The endoscope 102 can include an elongated body portion extending between a proximal end 104 and a distal end 106. The precise shape of the elongated body portion can depend on the medical procedure for which the endoscope 102 was originally designed. For simplicity, the elongated body portion is shown as being a cylinder, and having a circular cross-section, taken orthogonal to the direction of elongation. Other suitable shapes can also be used. During use in a procedure, the endoscope 102 can extend distally toward a target site 110.

[0044] The endoscope 102 can include one or more light sources or light emitters 108 at the distal end 106 of the endoscope 102 to illuminate the target site 110. Examples of suitable light emitters 108 can include a light-emitting diode, such as a white light-emitting diode, an arc lamp, such as a xenon arc lamp, and others. The endoscope 102 can include one or more cameras or imaging sensors 112 at the distal end 106 of the endoscope 102 to capture an image, such as a real-time video image, of the illuminated target site 110.

[0045] The endoscope 102 can include one or more heating elements 114, such as electrically resistive heaters, that can controllably heat the target site 110 or one or more other suitable regions on the endoscope 102. The endoscope 102 can include one or more cooling elements 116, such as thermoelectric coolers, that can controllably cool the target site 110 or one or more other suitable regions on the endoscope 102.

[0046] The endoscope 102 can provide insufflation media, such as helium or carbon dioxide, via an insufflation media port 120, to the target site 110 to temporarily inflate the target site 110 during the procedure. The endoscope 102 can provide a flushing agent, such as saline, via a flushing agent port 122, to the target site 110 such as to help cool or remove particles, such as kidney stone fragments, that may be generated during the procedure. In another example, the delivery and removal channels can be split into two separate channels. In some cases, a working channel can be included to allow for use of other device(s) to be introduced at the site.

[0047] The endoscope 102 can include various electrical connections that extend along a length of the endoscope 102, such as to electrically power the one or more light emitters 108, deliver data signals from the one or more imaging sensors 112, electrically power the one or more heating elements 114, electrically power the one or more cooling elements 116, and others. Although the electrical connections in FIG. 1 are shown as each extending proximally to a respective location at the proximal end 104 of the endoscope 102, in practice, the electrical connections can be grouped together so that the electrical connections can be made with a single connector at or near the proximal end 104 of the endoscope 102. For example, in practice, the electrical connections can extend along a single channel within the endoscope 102 and can fan out as needed at or near the distal end 106 of the endoscope 102.

[0048] The surgical system 100 can include at least one therapeutic optical fiber 118 to deliver therapeutic laser light via the endoscope 102. The at least one therapeutic optical fiber 118 can be positionable to extend from the distal end 106 of the endoscope 102. Thetherapeutic optical fiber 118 can be configured to emit the therapeutic fiber light toward the target site 110.

[0049] The surgical system 100 can include a therapeutic laser light source 128 that can generate the therapeutic laser light, direct the therapeutic laser light into a proximal portion of the therapeutic optical fiber 118, and direct the therapeutic laser light distally along a length of the therapeutic optical fiber 118 to emerge from a distal end of the therapeutic optical fiber 118 to form the therapeutic fiber light.

[0050] The surgical system 100 can include a sensing optical fiber 124 that can extend to a distal portion of the endoscope 102. The sensing optical fiber 124 can include a fiber Bragg grating 126 disposed at a distal portion of the sensing optical fiber. The sensing optical fiber 124 may include more than one fiber Bragg grating 126 along a length of the sensing optical fiber 124. For example, the sensing optical fiber 124 can include a first fiber Bragg grating 126 A and a second fiber Bragg grating 126B located proximal to the first fiber Bragg grating 126A. Using multiple fiber Bragg gratings 126 along the sensing optical fiber 124 can allow the surgical system to determine one or more physical conditions at the locations of the fiber Bragg gratings 126. For example, the sensing optical fiber 124 can be routed in the endoscope 102 to have the first fiber Bragg grating 126A at or near the distal end 106 of the endoscope 102, to determine a physical condition at or near the target site 110, and the second fiber Bragg grating 126B, to determine a physical condition at or near a component of the endoscope 102, such as the handle. Other locations can also be used.

[0051] In some cases, the sensing optical fiber 124 can be positional or navigation fibers made of bundles of fibers. In some cases, these fibers can be heliacally wound around each other and / or around a central cord, which can allow the system to see compression or extension of those bundles. In some cases, a bundle of seven fibers that are helically wound and bound together can be used, such as with three active fibers having FBGs in them and four spacer fibers. In an example, such a bundle can be extruded as a single bundle. In another example, the fibers can be created with a single extrusion bundle with three active FBG-containing fibers. Thus, a fiber can be a single fiber or a bundle of multiple fibers.

[0052] Alternatively, or in addition, using multiple fiber Bragg gratings 126 along the sensing optical fiber 124 can allow the surgical system 100 to compare the physical conditions at two different locations. For example, the surgical system 100 can use measurements of pressure or fluid pressure, taken at two different locations along a fluid channel, to determine whether the fluid channel is blocked.

[0053] The one or more fiber Bragg gratings 126 can aid in navigation of the endoscope 102. The surgical system 100 can include a sensing controller 130 coupled to the sensing optical fiber 124. The sensing controller 130 can direct sensing light distally along the sensing optical fiber 124 such that at least some of the sensing light reflects from the fiber Bragg grating 126 as reflected light.

[0054] In one example of navigation based on the use of the fiber Bragg gratings 126, the sensing controller 130 can perform optical frequency domain reflectometry on the reflected light. The sensing controller 130 can determine, from the optical frequency domain reflectometry, a parameter value at the fiber Bragg grating 126. Suitable parameter values can include pressure values, temperature values, and others. Such parameters can be correlated to a location of the device and the fiber Bragg grating 126.

[0055] For example, pressure at a fiber Bragg grating 126 can be correlated to a location within the patient anatomy. Where the endoscope 102 is being moved through the patient anatomy, a flexible portion of the endoscope 102 can be physically crushed, bent, deflected, or otherwise shaped according to pressure exerted by the nearby anatomy. The change in pressure, temperature, or other parameters of the fiber Bragg gratings during such movement within the patient anatomy can be correlated to one or more physical coordinates within the patient anatomy.

[0056] In some cases, the determination of a location of a device within a patient anatomy via fiber Bragg gratings can be used to produce a map of patient anatomy. In some cases, the determination of a location of a device within a patient anatomy via fiber Bragg gratings can be used to compare to a prior-produced map and locate the device. Such a prior produced map can, for example, be a map produced specific to the patient, and provided with the patient chart or medical information.

[0057] In either case, an anchor point or main access location can be used to orient the location tracking. For example, a natural patient anatomy marker, such as a specific opening or landmark, or an artificial marker, such as a tattoo, can act as the zero, zero coordinate point from which other location coordinates can be extrapolated. In some cases, a port can be created for the device and placed. Such a port can have a known and recognized shape, and can be leveraged as a known marker there forward. In some cases, a tattoo can be used as this “ground zero” or a base area to orient the navigation. In some cases, particular shapes in the anatomy can help bolster such a ground zero and orientation.

[0058] In the case of the use of fiber Bragg gratings for localization, for sensing optical fibers 124 that include multiple fiber Bragg gratings 126, the sensing controller 130 can determine the parameter values at some or all of the locations of the fiber Bragg gratings 126, and can do so essentially simultaneously via the optical frequency domain reflectometry.

[0059] In an example, the sensing controller 130 can use optical frequency domain reflectometry (OFDR) with the sensing optical fiber 124 to determine a temperature value and / or a (fluid) pressure value at the location of the fiber Bragg grating 126, or at one or more fiber Bragg gratings 126 disposed along the sensing optical fiber 124. The sensing controller 130 can include a variable frequency laser beam coupled to an optical interferometer. The sensing controller 130 can split light from the variable frequency laser beam between a reference arm and a measurement arm of an interferometer. In the optical path of the measurement arm, the sensing controller 130 can further split the light to propagate distally along a length of the sensing optical fiber 124 that includes a fiber Bragg grating 126, and return proximally along the sensing optical fiber 124. Light in the measurement arm can interfere with light in the reference arm to form an interference pattern. The sensing controller 130 can include an optical detector that can detect the interference pattern.

[0060] Other suitable configurations can also be used to device coordinates at one or more fiber Bragg gratings 126 disposed along the sensing optical fiber 124.

[0061] For example, the polarization-maintaining fiber can have a cross-section that includes a core at its center, and two holes on opposite sides of the core. The holes can define two hollow (or gas-filled) passages that extend along a length of the fiber on opposite sides of the core. The holes can optionally be circular in cross-section. The holes induce a birefringence in the fiber, such that a cross-sectional axis extending through centers of the holes can define a slow axis, and a cross-sectional axis extending between the holes (e.g., with the holes on opposite sides of the axis) can define a fast axis. The core can optionally have a cross-section that is elongated along the fast axis. In the polarization-maintaining fiber, light launched into the fiber with a linear polarization aligned with the fast axis can emerge from the fiber with a linear polarization that is aligned with the fast axis. Similarly, light launched into the fiber with a linear polarization aligned with the slow axis can emerge from the fiber with a linear polarization that is aligned with the slow axis.

[0062] In addition to providing the birefringence in the fiber, the holes can provide a relatively high sensitivity to pressure along the fast axis and a relatively low sensitivity to pressure along the slow axis. For example, a change in pressure may shift a wavelength atwhich a fiber Bragg grating 126 is reflective by a relatively small wavelength shift for the slow axis and a relatively large wavelength shift for the fast axis. In contrast to pressure, the sensitivity to temperature may be the same along the slow and fast axes. For example, a change in temperature value may shift a wavelength at which the fiber Bragg grating 126 is reflective by the same wavelength shift for both the slow axis and the fast axis.

[0063] Because the polarization-maintaining fiber (having holes therethrough) shows a direction-dependent difference in pressure sensitivity but not in temperature sensitivity, the polarization -maintaining fiber (having holes therethrough) can allow the surgical system 100 to separate the effects of temperature from pressure, and therefore obtain more accurate values of both temperature and pressure.

[0064] Specifically, the sensing controller 130 can direct first sensing light, which is linearly polarized along the slow axis of the sensing optical fiber 124, distally along the sensing optical fiber 124, and direct second sensing light, which is linearly polarized along the fast axis of the sensing optical fiber 124, distally along the sensing optical fiber 124. The sensing controller 130 can take two measurements of pressure, with one for the first sensing light and one for the second sensing light. The sensing controller 130 can use a difference in value between the two pressure measurements, optionally with one or both of the pressure measurements, and optionally with one or both of the temperature measurements, to accurately determine the pressure values at the fiber Bragg gratings 126. In other words, detecting changes in the wavelength difference between the reflected fast axis and slow axis signals can allow the surgical system 100 to detect and measure pressure changes at the fiber Bragg gratings, and do so independent of temperature variations and strain at the fiber Bragg gratings. The surgical system 100 can use the OFDR techniques described herein to perform the pressure and temperature measurements and can optionally take a set of measurements for the fast axis and a another set of measurements for the slow axis to more accurately determine the pressure and / or temperature.

[0065] In some cases, the sensing optical fiber 124 may include more than one fiber Bragg grating 126. In an example, the parameter sensed by the more than one fiber Bragg gratings can be a pressure. Here, the fiber Bragg grating 126 can be a first fiber Bragg grating 126 A. The sensing optical fiber 124 can include a second fiber Bragg grating 126B located proximal to the first fiber Bragg grating 126 A. The sensing controller 130 can determine, from the optical frequency domain refl ectom etry, a first pressure value at the first fiber Bragg grating 126 A and a second pressure value at the second fiber Bragg grating 126B.The processing circuitry 132 can analyze the first pressure value and the second pressure value by comparing a difference between the first pressure value and the second pressure value to a specified criterion, such as to a threshold pressure difference. The processing circuitry 132 can determine, from the analysis of the first pressure value and the second pressure value, that the pressure at the target site 110 exceeds a threshold pressure difference. This information can be correlated to location of the device within the patient anatomy.

[0066] Additional navigational components, such as magnetic coils, can also be used, such as discussed below with reference to FIG. 2. Such navigation components, including fiber Bragg gratings, can be used not only to initially map out a patient anatomy, but also to later localize a medical instrument when returning to that anatomy. Various different navigational components can be used together to confirm device location in a surgical procedure without the need of fluorescent markers.

[0067] The surgical system 100 can include processing circuitry 132 coupled to the sensing controller 130. The processing circuitry 132 may be referred to as a controller. The processing circuitry 132 may be implemented purely in software. The processing circuitry 132 may be implemented purely in hardware. In some examples, processing circuitry 132 may be implemented as a combination of software and hardware. The processing circuitry 132 may be implemented on a single processor. The processing circuitry 132 may be implemented on multiple processors. The multiple processors may be housed in a common housing, such as housing 134. In some examples, at least two of the multiple processors may be spaced apart in different housings. The housing 134 can house one or more of the processing circuitry 132, the sensing controller 130, or the therapeutic laser light source 128. The processing circuitry 132 can include one or more processors, memory containing instructions that are executable by the one or more processors to cause the one or more processors to perform operations. Examples of such operations are detailed below.Additional example of suitable controllers or processing circuitry are shown and discussed below.

[0068] FIG. 2 illustrates an example suction catheter system 200 having a navigation component. The suction catheter system 200 can include, as discussed herein, a catheter for use with a lithotripsy or other medical device system.

[0069] Urinary stones, such as ureteral and kidney stones, can often repeat in patients. For this reason, the application of the navigation techniques herein can help add to the patient history of stones, and allow for provider knowledge for recurring stones and / or ureteralstrictures. The inclusion of these blind navigation techniques and coordinates in the patient history can help the provider adjust treatment plans for stones, such as to prevent traumatizing tissue that has already been treated multiple times. These techniques could allow the provider to move the stone to another location based on such history. In some cases, the provider can avoid or adjust a particular treatment type based on this information. This could help reduce ureteral stricture, and potentially help reduce future stone production at those sites, and / or help reduce undesirable patient outcomes.

[0070] In some cases, the suction catheter system 200 can include another form of medical sheath. For example, the use of ‘blind’ navigation techniques, can additionally or alternatively be incorporated into a variety of other sheath, such as those described in patent publications U.S. 2015 / 0305759 Al and US2015 / 0305758 Al, which are herein incorporated by reference in their entirety.

[0071] The “blind” navigation techniques which can be used with the suction catheter system 200 can include, but are not limited to, a radio-opaque band, electromagnetic navigation coils, an optical navigation system such as fiber Bragg gratings, optical sensing fibers, turbidity sensors, pressure feedback, and combinations thereof.

[0072] The suction catheter system 200 can include a deflectable catheter 210 with a proximal end 212, a distal end 214, a shaft 216, a scope tip 218; a controller 250 connected with a blind navigation component 252 and a data connection 254; and a connector 220 with a fluid inlet 222, a fluid outlet 224, a particle detector end 226, and a particle detector 228.

[0073] The deflectable catheter 210 can extend between the proximal end 212 and the distal end 214 as a shaft 216, terminal in the scope tip 218 at the distal end 214. The deflectable catheter 210 can be sized and shaped for insertion into a patient, such as at or near a lithotripsy treatment site. The deflectable catheter 210 can be navigated blindly without the use of irradiating imaging techniques.

[0074] The controller 250 can be used to help turn on and off suction within the deflectable catheter 210 such as to allow suctioning of stone fragments out of the treatment area. The controller 250 can include, for example, one or more buttons, switches, valves, or other mechanisms, such as those connected to a suction or vacuum device.

[0075] The connector 220 (shown zoomed) can be a connection piece fluidly coupled to the deflectable catheter 210 so as to allow fluid flow in and out of the deflectable catheter 210. The connector 220 can include the fluid inlet 222, the fluid outlet 224, the particle detector end 226, and the particle detector 228. The fluid inlet 222 can receive fluid, and thefluid outlet 224 can expel fluid. Fluid incoming from the connector 220 can be used, for example, to irrigate in the deflectable catheter 210. The particle detector end 226 can provide a connection between the deflectable catheter 210, the controller 250, and the deflectable catheter 210 to provide suction thereto.

[0076] The blind navigation component 252 can be situated, for example, on, or, or around the shaft 216 of the deflectable catheter 210. The blind navigation component 252 can be one or more components, or a combination of components, that allow for an operator to insert and / or navigate the deflectable catheter 210 blindly within a patient without relying on fluoroscopy or other irradiating imaging techniques.

[0077] In an example, the blind navigation component 252 can be navigation coils placed at the scope tip 218. Such coils could be imaged and location identified to allow for proximity to the targeted stone breakage site. Such coils can be, for example, electromagnetically actuatable coils. In this case, rapidly changing magnetic fields can be placed around the patient. This can allow for monitoring at the coils. In this case, an electrical current can be created and processed in the context of an electromagnetic field generator to define a location with a cartesian coordinate system.

[0078] The electromagnetic navigation system can allow for precise, real-time tracking of the catheter’s position within the patient’s body, enabling accurate guidance during medical procedures without the need for fluoroscopy or other radiation-based imaging techniques.

[0079] In an example, the electromagnetic coils can be used for navigation. The electromagnetic navigation coils can be placed at the scope tip of the catheter, such as at a distal end. When the catheter is inserted into the patient, these coils can be exposed to rapidly changing magnetic fields that are placed around the patient. As the coils move through these changing magnetic fields, they generate electrical currents. The generated electrical currents are then processed in the context of an electromagnetic field generator. This processing allows the system to define the location of the catheter tip within a Cartesian coordinate system.

[0080] As the catheter moves within the patient's body, the changing electrical currents in the coils provide continuous updates on its position. The positional data from the electromagnetic coils can contribute to creating detailed, patient-specific 3D maps of the relevant anatomy. The electromagnetic navigation data can be integrated with information from other sensors, such as the optical navigation system, to provide a more comprehensiveunderstanding of the catheter's position and its environment. By cross-referencing the electromagnetic data with data from other navigation components, the system can identify and correct potential errors. The electromagnetic navigation system can function without direct line of sight, making it useful in complex anatomical structures where optical navigation might be challenging.

[0081] Alternatively, an optical variant of this navigation technique could be employed within the system 200. Such optical navigation systems, such as those incorporating fiber Bragg gratings, can be used to navigate to specific locations in the patient anatomy, such as the location of stone breaking in the case of lithotripsy, where a sample is desired for biopsy, or a treatment location for other types of procedures, such as vascular or gastrointestinal procedures. Fiber Bragg gratings are optical elements that can be integrated into the sensing optical fiber extending to the distal portion of the endoscope. A sensing controller can direct light along this fiber and analyze the reflected light using optical frequency domain reflectometry (OFDR) to determine parameters such as pressure or temperature at the fiber Bragg grating's location.

[0082] The system can combine electromagnetic and optical navigation for enhanced accuracy and redundancy. This combination allows for compensation of each technique's limitations and provides more comprehensive positional data.

[0083] In some cases, if a similar optical system was incorporated into the suction catheter system 200 as used for the medical purpose, then the system 200 could be navigated back to the same position with the optical sensing fiber of the catheter system 200. This could be by the user, retracing the pathway for match the original or by a mechanized system, following the prior pathway that had been saved by the user or where it sensed the laser had been active last.

[0084] Other elements could also be attached to the system, as optical feedback has been reduced. For example, the particle detector 228 can be situated between the deflectable catheter 210 and the fluid outlet 224 to detect particles outgoing from the suction catheter system 200during suction or irrigation. In an example, this could be a turbidity sensor, which would assist the user in determining of the stone fragments were still being removed from the area or if the particular suction is now clear with no stone particles being evacuated.

[0085] Once the area is clear and the user informed via the sensor, then the user can reposition the catheter, until they were satisfied that the area in which the stone was broken, has the stone dust completely removed.

[0086] Other benefits and known capabilities of optical sensors could also be incorporated into the suction sheath, such as a pressure feedback element, ensuring that the pressure at the target site is not over or under pressurized. The feedback system could also control the suction and inflow and using the turbidity sensor, provide an indication if the dust has been removed in that area. The data connection 254 can be provided to allow for transmission of sensor data to a computing device.

[0087] Using a combination of navigation techniques offers several key advantages over relying on a single technique. For example, the combination of techniques can allow for enhanced accuracy and precision. By combining electromagnetic and optical navigation systems, the overall accuracy and precision of the device can be significantly improved. Each system can compensate for the limitations of the other, potentially resulting in more precise positioning and repositioning of the catheter. Moreover, having multiple navigation system components provides redundancy, which is beneficial in medical applications. If one system fails or encounters interference, the other can still function, ensuring continued navigation capability.

[0088] The combination of different navigational techniques can allow for versatility across different anatomical structures. Different navigation techniques may perform better in various anatomical structures or medical procedures. For example, electromagnetic navigation might be more effective in some situations, while optical systems like fiber Bragg gratings could be superior in others. A combination allows for adaptability across different medical fields and procedures. Moreover, in cases where a single navigation technique might struggle (e.g., in areas with complex or variable anatomy), a combination of techniques could provide the necessary flexibility to navigate effectively.

[0089] Multiple navigation techniques can also provide a more comprehensive set of data about the catheter's position and movement. This could lead to more detailed and accurate patient-specific “maps” for use in future procedures. Additionally, the integration of multiple navigation systems could provide more robust real-time feedback to the operator, potentially improving the speed and accuracy of procedures.

[0090] The combination of navigation techniques opens up possibilities for more advanced features, such as automated navigation to stored locations or integration with other medical imaging and diagnostic systems. Examples of other types of medical systems that can leverage these various navigation techniques are shown and discussed below withreference to FIGS. 3 to 7. Additional, other types of systems and instruments can benefit from these techniques.

[0091] Data processing and storage through the data connection 254 to an appropriate computer or controller (see, e.g., FIGS. 13-14) can be leveraged to generate location coordinates in real time, to produce maps of patient anatomy for later use, for verification of placement, and analysis of location data collected by the various techniques, such as the fiber Bragg grating, magnetic coils, or other sensors.

[0092] For example, the system can store and recall previous treatment locations, creating patient-specific “maps” for future procedures. This involves collecting and integrating data from various navigation components and sensors, then processing this data to generate a 3D map of the patient's relevant anatomy. Additionally, during procedures, the system continuously processes incoming navigation data to determine the catheter's current position relative to the stored map. This allows for precise positioning and repositioning of the catheter.

[0093] Implementation of these techniques can involve algorithms for data integration, 3D mapping, landmark identification, and path planning. Potential approaches could include Simultaneous Localization and Mapping (SLAM), deep learning-based 3D reconstruction, and reinforcement learning for optimized catheter movement, discussed below in more detail with reference to FIG. 10. The implementation of these navigation techniques aims to provide accurate, radiation-free guidance for medical procedures across various specialties, potentially improving patient outcomes and reducing risks associated with traditional fluoroscopy -based navigation.

[0094] The data storage and recall feature of the navigation system can be done, for example, by recording the precise locations and pathways taken during an initial procedure or examination. This information could be stored digitally and associated with a patient's medical record. Given the potentially large amount of data involved in creating detailed patient-specific maps, the system can employ data compression techniques to efficiently store and retrieve this information.

[0095] For subsequent procedures, the system could access this stored data to guide the catheter back to previously visited locations. The precision of repositioning would depend on several factors, including the accuracy of the navigation technique(s) employed, the types of navigation components or systems used, and the method of repositioning. For example, the use of electromagnetic navigation coils can provide precise positioning with a cartesiancoordinate system, while the use of fiber Bragg gratings could have potential for good repositioning capabilities. In some cases, return to previously visited locations can be automated or semi-automated.

[0096] In an example, the catheter can be navigated back to the previously visited location by use of a guidewire in combination with the navigation data. For example, a guidewire would be used to get into the anatomy if the anatomy itself is small and / or fragile. For example, such a guidewire could be used through the ureteral orifice in urology applications.

[0097] In an example, radiopaque bands could potentially be used in combination with the navigation techniques herein. For example, the navigation techniques can be used to provide the map or identify a location, and marker bands can be left behind when identified. This could be useful, for example, where a patient may require multiple treatments at the same site, or multiple rounds.

[0098] When using such a map in a subsequent procedure, the system could guide a user manually to retrace the pathway according to the patient anatomy map, or used an automated or partially automated system, such as a robotic system, to follow a previously- saved pathway. In an example, such a map can be visualized for an operator on a user interface, such as those discussed herein with reference to FIGS. 1 above and FIGS. 3-7 below. Such visual, 3D representation can allow for clear, real-time visualization of the device’s position within the patient anatomy.

[0099] The use of a recorded “map” within a patient's anatomy could be useful. For example, in urology procedures, it could allow the user to mark and return to specific calyxes in the kidney without needing to re-enter each one individually. In other medical fields, this feature could enable precise return to biopsy sites, treatment areas, or locations of interest across multiple procedures. This could be especially useful in cases where the patient's anatomy might change slightly between procedures, as the system could help quickly locate previously treated areas. These navigation techniques can be used in combination with other localization and visualization techniques.

[0100] FIG. 3 illustrates a lithotripsy device with navigation capability in an example. The system 300 can be used, for example, in conjunction with a suction catheter system having blind guiding components that do not include fluoroscopy. In the example of FIG. 3, any type of processor and / or user interface can optionally be integrated with the rest of the system, or an external unit to the laser unit. In an example, the navigation techniquesdiscussed herein can be used with such lithotripsy devices, such as to address multiple calyxes by identifying those together, instead of individually.

[0101] The system 300 may include a surgical laser 302 and a graphical user interface 304. The graphical user interface 304 may include a touchscreen or other input mechanism configured to operate or control the surgical laser 302. The surgical laser 302 may include one or more laser sources configured to emit laser radiation.

[0102] As shown in the dashed box in the example of FIG. 3, the light sources may include an ablation laser 306 and / or an illumination source 308. The illumination source 308 may include a probe laser, a Light Emitting Diode (LED), a Xenon-based light source, or any similar source of visible light. The ablation laser 306 may emit a variety of different types of laser frequencies, such as infrared radiation, while the illumination source 308 may emit an aiming beam or an illumination beam of visible light to show where the tip of the scope is aimed. Additionally, or alternatively, the illumination source 308 may be used to illuminate a target 326 or the surgical scene or field. The target 326 can be a piece of tissue, debris, or an object, such as a kidney stone which is to be ablated, a tumor, a prostate capsule, or the like.

[0103] The emitted light 328 from the ablation laser 306 or the illumination source 308, may be emitted through an optical fiber 316 such as can be connected to a surgical fiber 318 via an optical connector 320. In an example, the structure of the surgical fiber 318 may be the same or different from that of the optical fiber 316. The surgical fiber 318 may be located wholly or partially outside the surgical laser 302. The emitted light 328 may thus be emitted from illumination source 308, through the optical fiber 316, the optical connector 320, and the surgical fiber 318, to a distal end of the surgical fiber 318. The distal end of the surgical fiber 318 may be inserted into a scope 324, such as an endoscope, a ureteroscope, laryngoscope, or the like. In an example, at least a portion of the emitted light 328 emitted from the distal end of the surgical fiber 318 and the scope 324 may be reflected off of, scattered by, or the like, a target 326 through a medium between the tip of the scope 324 and the target 326.

[0104] The surgical laser 302 may further include or couple to an optical component such as optical splitter 310, configured to collect at least a portion of the reflected light 330 passing through the aperture of the surgical fiber 318. In an example, the optical splitter 310 may be replaced with a dedicated fiber configured to collect at least a portion of the reflected light 330. The portion of reflected light 330 collected by the optical splitter 310 or dedicated fiber may be sent to a processor 312 in connection with or coupled to the surgical laser 302.An optical detector 332 may be located between the optical splitter 310 and the processor 312, so that spectral analysis of the reflected light 330 may be performed in order to determine one or more characteristics of the target 326.

[0105] The processor 312 and / or optical detector 332 may analyze the portion of the reflected light 330 collected by the optical splitter 310, to analyze the reflected light 330. The surgical laser 302 may optionally or additionally include controller 314 circuitry communicatively coupled to the processor 312 that may cause the optical detector 332 to collect or analyze the reflected light 330.

[0106] The system 300 can optionally include one or more navigation components, such as a radio-opaque band, electromagnetic navigation coils, an optical navigation system such as fiber Bragg gratings, optical sensing fibers, turbidity sensors, pressure feedback, and combinations thereof. For example, one or more fiber Bragg gratings may be used with the surgical laser 302, such as on a dedicated fiber, and used to locate the device such as described with reference to FIGS. 1-2 above.

[0107] FIGS. 4-5 illustrate a respiratory device with navigation capability in an example. In an example, such a respiratory device could be used to both do diagnostic assessment, followed by therapeutic assessment, using these navigation techniques. Leveraging the navigation techniques to return to the same location can allow for treatment affecting the respiratory system, such as affecting lymph nodes or other nodular structures in the airways.

[0108] FIG. 4 is a schematic diagram of an endoscopy system 410 that may include an imaging and control system 412 and an endobronchial ultrasound sampling arrangement including an endoscope 428 and a sampling device that is attachable to the endoscope 428 and which includes a distal end 430 that extends from the distal end of the endoscope 428 via a distal working channel port. The system of FIG. 4 is an illustrative example of an endoscopy system suitable for use with the systems, devices, and methods described herein, such as a bronchoscope with linearly arranged ultrasound elements.

[0109] The endoscope 428 may be insertable into an anatomical region for imaging or attachment to (e.g., via tethering) one or more sampling devices for biopsies or therapeutic devices for treating a disease state associated with the anatomical region. The endoscope 428 may interface or connect to the imaging and control system 412. The endoscope 428 is described in the present example as a bronchoscope, though other types of endoscopes are contemplated for use with the features and teachings of the present disclosure. The imagingand control system 412 may include a control unit 416, a display unit 418, an input unit 420, a light source 422, a fluid source 424, and a suction pump 426.

[0110] The imaging and control system 412 may include various ports for coupling with the endoscopy system 428. For example, the control unit 416 may include a data input / output port for receiving data from and communicating data to the endoscope 428. The light source 422 may include an output port for transmitting light to the endoscope 428, such as via a fiber optic link.

[0111] The system 410 can optionally include one or more navigation components, such as a radio-opaque band, electromagnetic navigation coils, an optical navigation system such as fiber Bragg gratings, optical sensing fibers, turbidity sensors, pressure feedback, and combinations thereof. For example, one or more fiber Bragg gratings can be included in the imagining and control system 412, such as along a fiber. In another example, one or more magnetic coils may be included in the system 410, such as at a distal end of the endoscope 428. In some cases, additional or alternative sensors, such as those described above with reference to FIG. 2, can be used.

[0112] The fluid source 424 may include a port for transmitting fluid to the endoscope 404. The fluid source 424 may include, for example, a pump and a fluid tank or may be connected to an external tank, vessel, or storage unit. The suction pump 426 may include a port to draw a vacuum from the endoscope 428 to generate suction, such as for withdrawing fluid from the anatomical region into which the endoscope 428 is inserted. The display unit 418 and the input unit 420 may be used by an operator of the endoscopy system 410 to control functions of the endoscopy system 400 and view the output of the endoscope 404. The control unit 406 may also generate signals or other outputs from treating the anatomical region into which the endoscope 404 is inserted. In examples, the control unit 416 may generate electrical output, acoustic output, fluid output, or the like for treating the anatomical region with, for example, cauterizing, cutting, freezing, or the like.

[0113] The endoscope 428 may include an insertion section and a functional section on the distal end 430, and a handle section 432, which may be coupled to a cable section 434 and a coupler section 436. The insertion section may extend distally from the handle section 432, and the cable section 434 may extend proximally from the handle section 432. The insertion section may be elongated and include a bending section and a distal end to which the functional section may be attached. The bending section may be controllable (e.g., by a steering control 438 on the handle section 432) to maneuver the distal end through tortuousanatomical passageways (e.g., stomach, duodenum, kidney, ureter, trachea, lungs, or the like). The insertion section may also include one or more working channels (e.g., an internal lumen) that may be elongated and may support the insertion of one or more therapeutic tools of the functional section, such as a bronchoscope. The working channel may extend between the handle section 432 and the functional section. Additional functionalities, such as fluid passages, guide wires, and pull wires, may also be provided by the insertion section 428 (e.g., via suction or irrigation passageways, or the like).

[0114] A coupler section 436 may be connected to the control unit 416 to connect to the endoscope 428 to multiple features of the control unit 416, such as the input unit 420, the light source 422, the fluid source 424, and the suction pump 426.

[0115] The handle section 432 may include the steering control 438 and the port 440. The steering control 438 may be a knob, lever, or other actuation mechanism or the like, which may be used to navigate the endoscope 428 within the patient. The steering control 438 may be connected to a pull wire or other actuation mechanisms, extending through the insertion section. The port 440, as well as other ports, may be configured to couple various electrical cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubes, and the like to the handle section 432, such as for coupling with the insertion section. The examples shown in FIG. 4 and FIG. 5 are examples of endoscopes 428.

[0116] According to examples, the imaging and control system 412 may be provided on a mobile platform (e.g., a cart) with shelves for housing the light source 422, the suction pump 426, an image processing unit 442, or the like. Alternatively, components of the imaging and control system 412, shown in FIG. 4 and FIG. 5, may be provided directly on the endoscope 404 to make the endoscope “self-contained.”

[0117] The functional section on the distal end 430 may include components for treating and diagnosing the anatomy of a patient. The functional section may include an imaging device, an illumination device, and an elevator. The functional section may further include optically enhanced biological matter and tissue collection and retrieval devices as described herein. For example, the functional section may include one or more electrodes conductively connected to the handle section 432 and functionally connected to the imaging and control system 402 to analyze biological matter in contact with the electrodes based on comparative biological data stored in the imaging and control system 412.

[0118] A sampling device may extend from a distal end 430 of the endoscope 428. The sampling device may be configured to be attached to the port 440 such that the samplingdevice extends through a working channel of the endoscope 428 and out the distal end 430 of the endoscope 428.

[0119] FIG. 5 is a schematic diagram of the endoscopy system 410 of FIG. 4, including the imaging and control system and the endobronchial ultrasound arrangement, which includes an endoscope and a sampling device extendable via a distal working channel port of the endoscope. FIG. 5 schematically illustrates the imaging and control system components coupled to the endoscope 428.

[0120] The imaging and control system may include the control unit 416, which may include or be coupled to an image processing unit 442, a treatment generator 444, and a drive unit 446, as well as the light source 422, the input unit 420, and the display unit 418. The control unit 416 may include or may be in communication with, an endoscope, a surgical instrument, and an endoscopy system, which may include a device configured to engage tissue and collect and store a portion of that tissue and through which imaging equipment (e.g., a camera) may view target tissue via the inclusion of optically enhanced materials and components. The control unit 416 may be configured to activate a camera to view target tissues distal of the endoscopy system. Likewise, the control unit 416 may be configured to activate the light source 422 to shine a light on the surgical instrument, which may include select components configured to reflect light in a particular manner, such as tissue cutters being enhanced with reflective particles.

[0121] The imaging and control system may include the light source 422 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrowband imaging using preferred electromagnetic wavelengths, and the like). The imaging and control system may connect (e.g., via an endoscope connector) to the endoscope 404 for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, and the like).

[0122] The fluid source 424 (shown in FIG. 4) may be in communication with the control unit 416 and may include one or more sources of air, saline, or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels, and the like) and connectors (barb fittings, fluid seals, valves, and the like). The imaging and control system may also include a drive unit 446, which may include a motorized drive for advancing a distal section of endoscope 428.

[0123] The coupler section 436 may be connected to the control unit 416 to connect to the endoscope 428 to multiple features of the control unit 416, such as the imageprocessing unit 442, the treatment generator 444, or the like. In examples, the port 430 may be used to insert another instrument or device, such as a daughter scope or auxiliary scope, or a sampling needle, biopsy needle, ablation instrument, scalpel, or the like, into the endoscope 428. Such instruments and devices may be independently connected to the control unit 416 via a cable section 434. For example, the port 440 may connect the coupler section 436 to various inputs and outputs, such as video, air, light, and electricity.

[0124] The image processing unit 442 and the light source 422 may each interface with the endoscope 428 or the sampling device by wired or wireless electrical connections. The imaging and control system may accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on the display unit 418.

[0125] In one or more examples, the image processing unit 442 may be an ultrasound image processing unit configured to receive ultrasonic signals from either the endoscope 428 or the sampling device, which may be converted into ultrasonic images and transmitted to the display unit 418 or any other component of the endoscopy system 410. In examples, the ultrasound image processing unit (and other components of the endoscopy system 410 (e.g., control unit 416, or the like) may use edge detection techniques to monitor an angle of extension of the instrument from the medical device or the shape or curvature found in the instrument as it extends from the medical device. The ultrasound image processing unit may then compare the angles of extension or profiles of curvature in the instrument to known angles of extension or profiles of curvature to determine when either of the angle of extension or profile are beyond a threshold value.

[0126] In examples, a machine learning component may be trained to monitor the angle of extension and curvature profile of the instrument and determine when the angle of extension or a curvature profile of the instrument are beyond a threshold. Regardless, if the ultrasound image processing unit (or other computing device) is using machine learning or edge detection, the ultrasound image processing unit may determine potential anomalies in the instrument and generate one or more of a warning, alert, notification, or control signal (e.g., which may be transmitted to any component of the endoscopy system 410) in response to the detected potential anomalies in the instrument.

[0127] The navigation components discussed herein could be used in a variety of respiratory procedures, such as procedures using the system 410. For example, the navigation system could be used with a bronchoscopy, where the navigation system could aid innavigating the bronchial tree, potentially improving the accuracy of diagnostic sampling or therapeutic interventions in the lungs. In another example, the navigation system could be used with the system 410 for an endobronchial ultrasound (EBUS). Here, the system could enhance precision in transbronchial needle aspiration of lymph nodes or masses. In another example, the navigation system could be used for a lung biopsy, that is, for procedures targeting nodules or masses in the lung, the navigation system could potentially improve the accuracy of needle placement, reducing the need for multiple attempts.

[0128] FIGS. 6-7 illustrates a gastrointestinal (GI) device with navigation capability in an example. FIG. 6 is a schematic diagram of endoscopy system 600 comprising imaging and control system 612 and endoscope 614. The system 600 of FIG. 6 can be, for example, for use in a gastrointestinal setting or procedure. The system 600 can include a proximal end 602, a distal end 604, a control unit 606, and a user interface 608. In an example, the navigational techniques used herein can be applied to GI polyps, such as for returning to check on a previously-identified polyp. In general, such navigation techniques can be used to return to the general area of such polyps, and save the operator from extensive searching around.

[0129] The system of FIG. 6 is an illustrative example of an endoscopy system suitable for use with the systems, devices and methods described herein. According to some examples, endoscope 614 can be insertable into an anatomical region for imaging and / or to provide passage of one or more sampling devices for biopsies, or one or more therapeutic devices for treatment of a disease state associated with the anatomical region. Endoscope 614 can, in advantageous aspects, interface with and connect to imaging and control system 612. In the illustrated example, endoscope 614 comprises a duodenoscope, though other types of endoscopes can be used with the features and teachings of the present disclosure.

[0130] Imaging and control system 612 can comprise controller 616, output unit 618, input unit 620, light source 622, fluid source 624 and suction pump 626.

[0131] Imaging and control system 612 can include various ports for coupling with endoscopy system 600. For example, controller 616 can include a data input / output port for receiving data from and communicating data to endoscope 614. Light source 622 can include an output port for transmitting light to endoscope 614, such as via a fiber optic link.

[0132] The system 600 can optionally include one or more navigation components, such as a radio-opaque band, electromagnetic navigation coils, an optical navigation system such as fiber Bragg gratings, optical sensing fibers, turbidity sensors, pressure feedback, andcombinations thereof. For example, one or more fiber Bragg gratings can be included in the imagining and control system 612, such as along a fiber, so as to work with the light source 622, and other components of the imaging and control system 612 to provide a location. In another example, one or more magnetic coils may be included in the system 600, such as at a distal end of the endoscope. In some cases, additional or alternative sensors, such as those described above with reference to FIG. 2, can be used.

[0133] Fluid source 624 can include a port for transmitting fluid to endoscope 614. Fluid source 624 can comprise a pump and a tank of fluid or can be connected to an external tank, vessel or storage unit. Suction pump 626 can comprise a port used to draw a vacuum from endoscope 614 to generate suction, such as for withdrawing fluid from the anatomical region into which endoscope 614 is inserted. Output unit 618 and input unit 620 can be used by an operator of endoscopy system 600 to control functions of endoscopy system 600 and view output of endoscope 614. Controller 616 can additionally be used to generate signals or other outputs from treating the anatomical region into which endoscope 614 is inserted. In examples, controller 616 can generate electrical output, acoustic output, a fluid output and the like for treating the anatomical region with, for example, cauterizing, cutting, freezing and the like.

[0134] Endoscope 614 can comprise insertion section 628, functional section 630 and handle section 632, which can be coupled to cable section 634 and coupler section 636.

[0135] Insertion section 628 can extend distally from handle section 632 and cable section 634 can extend proximally from handle section 632. Insertion section 628 can be elongate and include a bending section, and a distal end to which functional section 630 can be attached. The bending section can be controllable (e.g., by control knob 638 on handle section 632) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, etc.). Insertion section 628 can also include one or more working channels (e.g., an internal lumen) that can be elongate and support insertion of one or more therapeutic tools of functional section 630. The working channel can extend between handle section 632 and functional section 630. Additional functionalities, such as fluid passages, guide wires, and pull wires can also be provided by insertion section 628 (e.g., via suction or irrigation passageways, and the like).

[0136] Handle section 632 can comprise knob 638 as well as ports 640. Knob 638 can be coupled to a pull wire extending through insertion section 628. Ports 640 can beconfigured to couple various electrical cables, fluid tubes and the like to handle section 632 for coupling with insertion section 628.

[0137] Imaging and control system 612, according to examples, can be provided on a mobile platform (e.g., cart 641) with shelves for housing light source 622, suction pump 626, image processing unit 642, etc. Alternatively, several components of imaging and control system 612 shown in FIGS. 6 and 7 can be provided directly on endoscope 614 so as to make the endoscope “self-contained.”

[0138] Functional section 630 can comprise components for treating and diagnosing anatomy of a patient. Functional section 630 can comprise an imaging device, an illumination device and an elevator. Functional section 630 can further comprise a biliary diagnostic device as is described herein. For example, functional section 630 can comprise one or more electrodes conductively connected to handle section 632 and functionally connected to imaging and control system 612 to analyze biological matter in contact with the electrodes based on comparative biological data stored in imaging and control system 612.

[0139] FIG. 7 is a schematic diagram of endoscopy system 600 of FIG. 6 comprising imaging and control system 612 and endoscope 614. The control unit 606 can be connected to and work in conjunction with the image processing unit 702, the ultrasound image processing unit 704, the treatment generator 706, the display unit 608, the input unit 610, and the light source unit 612, which can each function similarly to those components as described above with reference to FIGS. 4-5.

[0140] FIG. 7 schematically illustrates components of imaging and control system 612 coupled to endoscope 614, which in the illustrated example comprises a duodenoscope. Imaging and control system 612 can comprise controller 616, which can include or be coupled to image processing unit 642, treatment generator 644 and drive unit 646, as well as light source 622, input unit 620 and output unit 618. As is discussed below in greater detail, controller 616 can comprise, or can be in communication with a biliary diagnostic device, which can comprise electrodes positioned on functional section 630 or insertion section 628.

[0141] Image processing unit 642 and light source 622 can each interface with endoscope 614 (e.g., at functional section 630) by wired or wireless electrical connections. Imaging and control system 612 can accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on display unit 618. Imagingand control system 612 can include light source 622 to illuminate the anatomical region using light of desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like). Imaging and control system 612 can connect (e.g., via an endoscope connector) to endoscope 614 for signal transmission (e.g., light output from light source, video signals from imaging system in the distal end, diagnostic and sensor signals from a biliary diagnostic device, and the like).

[0142] Fluid source 624 can comprise one or more sources of air, saline or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels) and connectors (barb fittings, fluid seals, valves and the like). Imaging and control system 612 can also include drive unit 646, which can be an optional component. Drive unit 46 can comprise a motorized drive for advancing a distal section of endoscope 614.

[0143] The navigation components discussed herein could be used in a variety of gastrointestinal procedures, such as procedures using the system 600. For example, the navigation system could be used with Endoscopic Retrograde Cholangiopancreatography (ERCP), in which case the navigation system could assist in precisely guiding catheters through the bile and pancreatic ducts, potentially improving the accuracy of stone removal or stent placement. In another example the navigation system could be used for a colonoscopy, where the system could help navigate through complex colon structures, potentially improving polyp detection and removal. The ability to mark and return to specific locations could be particularly useful for follow-up examinations of suspicious areas. In another example, the navigation system could be used for an endoscopic ultrasound (EUS)-guided procedure, in which the navigation system could enhance precision in fine needle aspiration or biopsy procedures, allowing for more accurate targeting of lesions.

[0144] In these applications, the navigation system’s ability to create patient-specific “maps” and recall previous treatment locations could be particularly valuable for follow-up procedures or ongoing treatments. The combination of electromagnetic and optical navigation techniques could provide robust guidance in these often complex anatomical structures, potentially improving procedure outcomes and patient safety.

[0145] While several specific examples of endoscope devices are discussed herein, such as for lithotripsy, respiratory applications, and gastrointestinal applications, a variety of other types of endoscopy devices and systems could be used in conjunction with the navigation techniques and components discussed herein. For example, such navigation components could be applied to ear nose and throat (ENT) devices, oncology devices, andother vascular devices, in addition to other surgical systems and devices where navigation without a fluorescent marker is desired.

[0146] FIGS. 8-9 illustrate flow charts of blind navigation using fiber Bragg gratings in surgical systems in an example. FIG. 8 shows a flow chart of an example of a method 800 for operating a surgical system, such as surgical system 100 shown in FIG. 1, or any of the surgical systems shown or discussed above with reference to FIGS. 2-7 above.

[0147] In such a surgical system, an endoscope can extend distally toward a target site. A sensing optical fiber can extend to a distal portion of the endoscope and can include a fiber Bragg grating disposed at a distal portion of the sensing optical fiber. The method 800 can be executed by a suitable surgical system. For example, the method 800 can be executed by a monopolar or bipolar radiofrequency device, an ultrasonic stone breaking device, an ultrasonic device for tissue modification, a combined energy device, a cold plasma type device, a diagnostic device such as a needle sampler where the device uses insufflation for creating an improved view of the target site, a diagnostic device that uses cryogenic or radiofrequency energy to capture the sample, and others. The method 800 is but one method for operating a surgical system; other suitable methods can also be used.

[0148] At operation 802, a sensing controller can direct sensing light distally along the sensing optical fiber such that at least some of the sensing light reflects from the fiber Bragg grating as reflected light.

[0149] At operation 804, the sensing controller can perform optical frequency domain reflectometry (OFDR) on the reflected light. At operation 806, the sensing controller can determine, from the optical frequency domain reflectometry, a parameter value at the fiber Bragg grating. The parameter value can correlate to a location, such as a cartesian coordinate, of the fiber Bragg grating, and thus of the device.

[0150] At operation 808, processing circuitry, such as processing circuitry 132, can analyze the parameter value. At operation 810, the processing circuitry can determine, from the analysis of the parameter value, that a parameter at the target site satisfies a specified condition. At operation 812, the processing circuitry can generate an alert data signal, such an indication of a location of the fiber Bragg grating, or a shape of the device in question, such as a deflection status, in response to the determination that the parameter at the target site satisfies the specified condition. This can help localize portions or components in the device based on the reflection from the fiber Bragg gratings.

[0151] FIG. 9 shows a flow chart of an example of a method 900 for operating a surgical system, such those discussed herein. In the surgical system, an endoscope can extend distally toward a target site and provide insufflation media to the target site. A sensing optical fiber can extend to a distal portion of the endoscope and can include a fiber Bragg grating disposed at a distal portion of the sensing optical fiber. The method 900 can be executed by a suitable surgical system. The method 900 is but one method for operating a surgical system; other suitable methods can also be used.

[0152] At operation 902, a sensing controller can direct sensing light distally along the sensing optical fiber such that at least some of the sensing light reflects from the fiber Bragg grating as reflected light.

[0153] At operation 904, the sensing controller can perform optical frequency domain reflectometry (OFDR) on the reflected light. At operation 906, the sensing controller can determine, from the optical frequency domain reflectometry, a pressure value at the fiber Bragg grating.

[0154] At operation 908, processing circuitry, such as processing circuitry 132, can compare the pressure value to a specified criterion, such as to a threshold pressure value. For example, the pressure value can be correlated to a location of the device.

[0155] At operation 910, the processing circuitry can determine, from the comparison, that the pressure value exceeds a threshold pressure value. At operation 912, the processing circuitry can, in response to the determination that the that the pressure value exceeds the threshold pressure value, cause the endoscope to perform at least one of operations 914 or 916.

[0156] At operation 914, the endoscope can provide an alert to a user, device, or process, such as indicating a location or coordinate. At operation 916, the system can direct the endoscope to perform an action in response to the location, such as reduction of pressure.

[0157] FIG. 10 is a flowchart of an example method 1000 of producing and using a navigation map in a surgical system. The method 1000 can include steps of both producing an initial map, and using that map, regarding device navigation and location within a patient anatomy.

[0158] At step 1010, an initial map can be produced using one or more navigation components, such as fiber Bragg gratings, electromagnetic coils, other sensors, and combinations thereof. In this case, the operator, such as a surgeon, would begin by inserting amedical device, such as any of the endoscopes or devices discussed with reference to FIGS. 3 to 7 above, into a patient anatomy at or near a target site.

[0159] Data collection can be done about the patient anatomy and location of the device throughout the insertion and navigation. Here, leveraging the various navigation components and sensors, the system can collect precise positional data. For example, during the initial procedure, in real time, the system can receive data from the optical navigation system, electromagnetic coils, other sensors, or combinations thereof. This data can include the pathway through the patient’s anatomy as well as specific locations of interest. For example, in a urology procedure, the stone’s location can be recorded. In another example, biopsy sites can be recorded. Recordation and collection of such data can be done automatically during the procedure, semi -automatically where the system prompts the operator for data collection, or manually at the direction of the operator.

[0160] The system can then integrate data collected from multiple sources, including the navigation components, additional sensors (particle detector, turbidity sensor, pressure feedback element), and potentially existing patient imaging data. This integration can help create a comprehensive dataset representing the patient's unique anatomy and the procedure details. Such data can be stored in the patient’s file for future reference and use.

[0161] At step 1020, the system can produce a map based on use of the navigational components. Here, using the collected data, the system can generate a three-dimensional map of the patient's relevant anatomy. This map can use various appropriate algorithms to process the raw positional data into a coherent 3D model. In some cases, this can incorporate machine learning techniques for improved accuracy and detail.

[0162] In production of the map, the system can also identify landmarks or areas of interest, such as anatomical landmarks, prior procedure locations, prior biopsy location, and other places. These can be identified manually, or can be automatically identified, such as by pattern recognition and machine learning. For example, in urology procedures, the system could automatically identify and label different or multiple calyxes in the kidney.

[0163] Various algorithmic techniques, machine learning techniques, computer vision, robotics, and combinations, can be used to produce such a map. Potential approaches could include Simultaneous Localization and Mapping (SLAM), deep learning-based 3D reconstruction, point cloud registration, gaussian process regression, reinforcement learning, and others.

[0164] In an example, Simultaneous Localization and Mapping (SLAM) can be used to construct and update a map of the patient's anatomy while simultaneously tracking the catheter's position. Advanced SLAM algorithms like ORB-SLAM or LSD-SLAM could potentially be adapted for medical use.

[0165] In an example, Deep Learning-based 3D Reconstruction can be used in map construction. Convolutional Neural Networks (CNNs) or Graph Neural Networks (GNNs) could be employed to process sensor data and generate detailed 3D models of the patient's anatomy.

[0166] In an example, Point Cloud Registration can be used in map production. Algorithms like Iterative Closest Point (ICP) or its variants could be used to align and merge multiple sets of 3D data collected over time, allowing for continuous refinement of the patient-specific map.

[0167] In an example, gaussian process regression can be used to produce such a map. This technique can leverage machine learning to interpolate between known data points to create a continuous 3D map of the patient's anatomy.

[0168] In an example, reinforcement learning can be used to produce such a map. More specifically, for path planning and navigation, reinforcement learning algorithms like Deep Q-Networks (DQN) or Proximal Policy Optimization (PPO) could potentially be adapted to optimize catheter movement within the patient's anatomy.

[0169] At step 1030, the system can retrieve the prior produced map for subsequent procedure. The map can be used for path planning and navigation for the new procedure. For example, the system could use path planning algorithms to determine the optimal route to reach previously visited locations. This could involve considering factors such as the current position of the device, potential obstacles, and the desired end location.

[0170] At step 1040, the navigation components can be used in real time during the new procedure to gather additional location data and verify the planned pathway. The navigation components can additionally be used to verify current locations. During such follow-up procedures, the system can continuously process incoming navigation data to determine the device’s current position relative to the stored map. This can involve real-time data processing and comparison algorithms.

[0171] Additionally, the system can update the patient-specific map during each subsequent procedure, refining and updating the accuracy of the map over time. In somecases, this can include comparing new data with existing data, and making appropriate adjustments.

[0172] The methods can optionally and additionally incorporate procedures and algorithms for detecting and correcting potential errors in the navigation data and produced maps. The methods can optionally include one or more appropriate calibration routines to help ensure ongoing accuracy.

[0173] FIG.11 is a flowchart of an example method 1100 for mapping a target area in a patient. At step 1110, the method includes inserting a medical device into the patient near the target area, the medical device including an optical navigation system having at an optical fiber bundle and at least one fiber Bragg grating thereon. At step 1120, the method includes directing sensing light distally along the optical fiber bundle such that at least a portion of the sensing light reflects from the fiber Bragg grating as reflected light. At step 1130, the method includes performing optical frequency domain reflectometry on the reflected light; and determining the location of the target area based on the optical frequency domain reflectometry. At step 1140, the location of the target area can be determined.

[0174] FIG. 12 is a flowchart of an example method 1200 of using a navigation map in a surgical system. At step 1210, the method includes inserting a medical device into the patient near the target area, the medical device including a navigation system, such as an optical navigation system having at an optical fiber bundle and at least one fiber Bragg grating thereon. At step 1220, the method includes collecting navigation data in real time, such as by the fiber Bragg grating. At step 1230, the method includes determining the location of the target area based on a prior produced map and the real time data to determine a location of the device.

[0175] FIG. 13 shows a schematic diagram of an example of a computer-based clinical decision support system (CDSS) 1300 that is configured to determine whether a parameter value, such as a pressure value or a temperature value, satisfies a specified condition. In various embodiments, the CDSS 1300 includes an input interface 1302 through which the parameter value which is specific to a patient is provided as input features to an artificial intelligence (Al) model 1304, a processor which performs an inference operation in which the parameter value is applied to the Al model to determine whether the parameter value satisfies the specified condition, and a user interface (UI) or output interface 1308 through which the determination is communicated to a user, e.g., a clinician.

[0176] In some embodiments, the input interface 1302 may be a direct data link between the CDSS 1300 and one or more medical devices, such as surgical system 100 or endoscope 102, which generate at least some of the input features. For example, the input interface 1302 may transmit the parameter value directly to the CDSS during a therapeutic and / or diagnostic medical procedure. Additionally, or alternatively, the input interface 1302 may be a classical user interface that facilitates interaction between a user and the CDSS 1300. For example, the input interface 1302 may facilitate a user interface through which the user may manually enter the parameter value. Additionally, or alternatively, the input interface 1302 may provide the CDSS 1300 with access to an electronic patient record from which one or more input features may be extracted. In any of these cases, the input interface 1302 is configured to collect the parameter value in association with a specific patient on or before a time at which the CDSS 1300 is used to assess the medical condition addressed by a surgical system or endoscope, such as a kidney stone.

[0177] Based on one or more of the above input features, the processor, such as processing circuitry, performs an inference operation using the Al model to generate the determination. For example, input interface 1302 may deliver the parameter value into an input layer of the Al model which propagates this input feature through the Al model to an output layer. The Al model can provide a computer system the ability to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. Al model explores the study and construction of algorithms (e.g., machinelearning algorithms) that may learn from existing data and make predictions about new data. Such algorithms operate by building an Al model from example training data in order to make data-driven predictions or decisions expressed as outputs or assessments.

[0178] There are two modes for machine learning (ML): supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., examples that correlate inputs to outputs or outcomes) to learn the relationships between the inputs and the outputs. The goal of supervised ML is to learn a function that, given some training data, best approximates the relationship between the training inputs and outputs so that the ML model can implement the same relationships when given inputs to generate the corresponding outputs. Unsupervised ML is the training of an ML algorithm using information that is neither classified nor labeled and allowing the algorithm to act on that information without guidance. Unsupervised ML is useful in exploratory analysis because it can automatically identify structure in data.

[0179] Common tasks for supervised ML are classification problems and regression problems. Classification problems, also referred to as categorization problems, aim at classifying items into one of several category values (for example, is this object an apple or an orange?). Regression algorithms aim at quantifying some items (for example, by providing a score to the value of some input). Some examples of commonly used supervised-ML algorithms are Logistic Regression (LR), Naive-Bayes, Random Forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and Support Vector Machines (SVM).

[0180] Some common tasks for unsupervised ML include clustering, representation learning, and density estimation. Some examples of commonly used unsupervised-ML algorithms are K-means clustering, principal component analysis, and autoencoders.

[0181] Another type of ML is federated learning (also known as collaborative learning) that trains an algorithm across multiple decentralized devices holding local data, without exchanging the data. This approach stands in contrast to traditional centralized machine-learning techniques where all the local datasets are uploaded to one server, as well as to more classical decentralized approaches which often assume that local data samples are identically distributed. Federated learning enables multiple actors to build a common, robust machine learning model without sharing data, thus allowing to address critical issues such as data privacy, data security, data access rights and access to heterogeneous data.

[0182] The Al model may be trained continuously or periodically prior to performance of the inference operation by the processor, such as processing circuitry. Then, during the inference operation, the patient specific input features provided to the Al model may be propagated from an input layer, through one or more hidden layers, and ultimately to an output layer that corresponds to the determination.

[0183] The Al model can include a database, which can include data corresponding to a patient. The database can provide a patient record to the CDSS 1300. The Al model can receive a parameter value from a sensor.

[0184] During and / or subsequent to the inference operation, the value of distance (Z) may be communicated to the user via the user interface (UI) and / or automatically cause an actuator or an alarm connected to the processor to perform a desired action. For example, the processor can cause the actuator to move the optical fiber with respect to the endoscope. Alternatively, the processor can cause the alarm to alert the practitioner. The CDSS 1300 can optionally be used to determine the action taken in response to a parameter value.

[0185] FIG. 14 illustrates a block diagram of an example machine 1400 upon which any one or more of the techniques (e.g., methodologies) discussed herein may perform. Examples, as described herein, may include, or may operate by, logic or a number of components, or mechanisms in the machine 1400. Circuitry (e.g., processing circuitry) is a collection of circuits implemented in tangible entities of the machine 1400 that include hardware (e.g., simple circuits, gates, logic, etc.). Circuitry membership may be flexible over time. Circuitries include members that may, alone or in combination, perform specified operations when operating. In an example, hardware of the circuitry may be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuitry may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a machine readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation. In connecting the physical components, the underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa. The instructions enable embedded hardware (e.g., the execution units or a loading mechanism) to create members of the circuitry in hardware via the variable connections to carry out portions of the specific operation when in operation. Accordingly, in an example, the machine-readable medium elements are part of the circuitry or are communicatively coupled to the other components of the circuitry when the device is operating. In an example, any of the physical components may be used in more than one member of more than one circuitry. For example, under operation, execution units may be used in a first circuit of a first circuitry at one point in time and reused by a second circuit in the first circuitry, or by a third circuit in a second circuitry at a different time. Additional examples of these components with respect to the machine 1400 follow.

[0186] In alternative embodiments, the machine 1400 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 1400 may operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, the machine 1400 may act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. The machine 1400 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term“machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations.

[0187] The machine (e.g., computer system) 1400 may include a hardware processor 1402 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 1404, a static memory (e.g., memory or storage for firmware, microcode, a basic-input-output (BIOS), unified extensible firmware interface (UEFI), etc.) 1406, and mass storage 1408 (e.g., hard drive, tape drive, flash storage, or other block devices) some or all of which may communicate with each other via an interlink (e.g., bus) 1430. The machine 1400 may further include a display unit 1410, an alphanumeric input device 1412 (e.g., a keyboard), and a user interface (UI) navigation device 1414 (e.g., a mouse). In an example, the display unit 1410, input device 1412 and UI navigation device 1414 may be a touch screen display. The machine 1400 may additionally include a storage device (e.g., drive unit) 1408, a signal generation device 1418 (e.g., a speaker), a network interface device 1420, and one or more sensors 1416, such as a global positioning system (GPS) sensor, compass, accelerometer, or another sensor. The machine 1400 may include an output controller 1428, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.). The machine can include an output controller 1430.

[0188] Registers of the processor 1402, the main memory 1404, the static memory 1406, or the mass storage 1408 may be, or include a machine readable medium 1422 on which is stored one or more sets of data structures or instructions 1424 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. The instructions 1424 may also reside, completely or at least partially, within any of registers of the processor 1402, the main memory 1404, the static memory 1406, or the mass storage 1408 during execution thereof by the machine 1400. In an example, one or any combination of the hardware processor 1402, the main memory 1404, the static memory 1406, or the mass storage 1408 may constitute the machine-readable media 1422. While the machine readable medium 1422 is illustrated as a single medium, the term "machine readable medium" may include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store the one or more instructions 1424.

[0189] The term “machine readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 1400 and that cause the machine 1400 to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Non-limiting machine-readable medium examples may include solid-state memories, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In an example, a non- transitory machine-readable medium comprises a machine-readable medium with a plurality of particles having invariant (e.g., rest) mass, and thus are compositions of matter. Accordingly, non-transitory machine-readable media are machine readable media that do not include transitory propagating signals. Specific examples of non-transitory machine-readable media may include non-volatile memory, such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0190] The instructions 1424 may be further transmitted or received over a communications network 1426 using a transmission medium via the network interface device 1420 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), mobile telephone networks (e.g., cellular networks), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as Wi-Fi®, IEEE 802.16 family of standards known as WiMAX®), IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In an example, the network interface device 1420 may include one or more physical jacks (e.g., Ethernet, coaxial, or phonejacks) or one or more antennas to connect to the communications network 1426. In an example, the network interface device 1420 may include a plurality of antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input singleoutput (MISO) techniques. The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for executionby the machine 1400, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software. A transmission medium is a machine readable medium.

[0191] Various Notes & Examples

[0192] In some aspects, the techniques described herein relate to a system including: a medical device with a shaft having a proximal end and a distal end, the medical device configured to extend distally towards a target site; at least one navigation sensor integrated with the shaft, wherein the at least one navigation sensor is actuatable to provide a sensor response signal for navigation to the target site without requiring fluoroscopy or in vivo visualization; at least one response detector configured to determine a parameter value from the sensor response signal from the at least one navigation sensor; and signal processing circuitry, coupled to the at least one response detector, the signal processing circuitry configured to analyze the parameter value and a pre-produced map of the target site, determine a location of the medical device, and generate a location signal accordingly.

[0193] In some aspects, the techniques described herein relate to a system, wherein the pre-produced map of the target site was generated by use of a preliminary device separate from the medical device, the preliminary device including a preliminary navigation sensor and a preliminary response detector actuatable for mapping the target site.

[0194] In some aspects, the techniques described herein relate to a system, wherein the pre-produced map of the target site was generated by prior use of the at least one navigation sensor and the at least one response detector.

[0195] In some aspects, the techniques described herein relate to a system, wherein the at least one navigation sensor includes a sensing optical fiber extending to the distal end of the medical device, the sensing optical fiber including a fiber Bragg grating disposed at a distal end of the sensing optical fiber.

[0196] In some aspects, the techniques described herein relate to a system, wherein the at least one sensor is configured to direct sensing light distally along the sensing optical fiber such that at least a portion of the sensing light reflects from the fiber Bragg grating as reflected light, wherein the at least one sensor is configured to perform optical frequency domain reflectometry on the reflected light.

[0197] In some aspects, the techniques described herein relate to a system, wherein the at least one sensor is configured to determine the parameter value based on the optical frequency domain reflectometry of the reflected light.

[0198] In some aspects, the techniques described herein relate to a system, wherein the at least one navigation sensor includes an electromagnetic coil.

[0199] In some aspects, the techniques described herein relate to a system, wherein the electromagnetic coil is attached to the medical device at the distal end.

[0200] In some aspects, the techniques described herein relate to a system, further including an electromagnetic field generator configured to produce rapidly changing magnetic fields around the system, wherein the at least one sensor is configured to monitor an electrical current produced by the electromagnetic field generator.

[0201] In some aspects, the techniques described herein relate to a system, wherein the parameter includes Cartesian coordinates based on the monitored electrical current.

[0202] In some aspects, the techniques described herein relate to a system, further including a turbidity sensor on the proximal end of the medical device.

[0203] In some aspects, the techniques described herein relate to a system, wherein the medical device includes a urology device, a gastrointestinal device, an oncology device, or a vascular device.

[0204] In some aspects, the techniques described herein relate to a method including: retrieving a three-dimensional map of a patient anatomical area, the three-dimensional map produced during a first operation at the patient anatomical area; generating a proposed navigation path for a medical device in the patient anatomical area during a proposed second operation at the patient anatomical area; inserting the medical device in the patient area and navigating the medical device according to the proposed navigation path; collecting navigation data in real time with one or more navigation components integrated with the medical device; and adjusting the navigation path in real time according to the collected navigation data.

[0205] In some aspects, the techniques described herein relate to a method, further including updating the three-dimensional map of the patient anatomical area according to the collected navigation data.

[0206] In some aspects, the techniques described herein relate to a method, wherein collecting navigation data in real time includes directing sensing light distally along an optical fiber bundle with a fiber Bragg grating in the medical device; reflecting at least a portion of the sensing light from the fiber Bragg grating as reflected light; performing optical frequency domain reflectometry on the reflected light; and determining a location of the medical device based on the domain reflectometry.

[0207] In some aspects, the techniques described herein relate to a method, wherein collecting navigation data in real time includes producing rapidly changing magnetic fields around the medical device to induce an electrical current around an electromagnetic coil in the medical device; and calculating a location in Cartesian coordinates based on the electrical current.

[0208] In some aspects, the techniques described herein relate to a method, further including producing the three-dimensional map during the first operation at the patient anatomical area.

[0209] In some aspects, the techniques described herein relate to a method, wherein producing the three-dimensional map includes collecting a plurality of signal data from one or more navigational components integrated with the medical device; integrating the plurality of signal data; and using machine learning to produce the three-dimensional map based on the plurality of signal data.

[0210] In some aspects, the techniques described herein relate to a method of mapping a target area in a patient, the method including: inserting a medical device into the patient near the target area, the medical device including an optical navigation system having at an optical fiber bundle and at least one fiber Bragg grating thereon; directing sensing light distally along the optical fiber bundle such that at least a portion of the sensing light reflects from the fiber Bragg grating as reflected light; performing optical frequency domain reflectometry on the reflected light; and determining the location of the target area based on the optical frequency domain reflectometry.

[0211] In some aspects, the techniques described herein relate to a method, further including producing rapidly changing magnetic fields around the medical device to induce an electrical current around an electromagnetic coil; and calculating a location in Cartesian coordinates based on the electrical current.

[0212] Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.

[0213] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, thepresent inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0214] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.

[0215] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0216] Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine- readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

[0217] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used incombination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

CLAIMSWhat is claimed is:

1. A system comprising: a first medical device having a first navigation device integrated with the first medical device, the first navigation device actuatable to record a location in a patient anatomy without requiring fluoroscopy or in vivo visualization; a second medical device having a second navigation device integrated with the second medical device, the second navigation device actuatable to navigate the second medical device to the recorded location without requiring fluoroscopy or in vivo visualization.

2. The system of claim 1, wherein the first navigation device and the second navigation device each comprise: a navigation sensor configured to sense a response signal indicative of a position of the medical device in the patient anatomy; a navigation detector configured to determine a parameter value from the response signal from the sensor; and signal processing circuitry, coupled to the detector, the signal processing circuitry configured to analyze the parameter value, determine the position of the medical device, and generate a position signal to a user accordingly.

3. The system of claim 1, wherein the first navigation device is actuatable for producing a map of the patient anatomy, and the second navigation device is actuatable for interpreting the map of the patient anatomy.

4. The system of claim 1, wherein the first navigation device and the second navigation device each comprise a sensing optical fiber extending to the distal end of the medical device, the sensing optical fiber including a fiber Bragg grating disposed at a distal end of the sensing optical fiber.

5. The system of claim 4, wherein the first navigation device and the second navigation device each are configured to direct sensing light distally along the sensing optical fiber such that at least a portion of the sensing light reflects from the fiber Bragg grating as reflected light, and to perform optical frequency domain reflectometry on the reflected light.

6. The system of claim 5, wherein the first navigation device and the second navigation device each are configured to determine a parameter value based on the optical frequency domain reflectometry of the reflected light.

7. The system of claim 1, wherein the first navigation device and the second navigation device each comprise an electromagnetic coil.

8. The system of claim 7, wherein the electromagnetic coil is attached to each of the first medical device and the second medical device at a distal end thereof.

9. The system of claim 7, further comprising an electromagnetic field generator configured to produce rapidly changing magnetic fields around the system, wherein the first navigation device and the second navigation device each are configured to monitor an electrical current produced by the electromagnetic field generator.

10. The system of claim 9, wherein the first navigation device and the second navigation device each are configured to produce Cartesian coordinates based on the monitored electrical current.

11. The system of claim 1, further comprising a turbidity sensor on a proximal end of the first medical device, the second medical device, or both.

12. The system of claim 1, wherein the first medical device and the second medical device each comprise a urology device, a gastrointestinal device, an oncology device, a vascular device, or combinations thereof.

13. A method compri sing : recording a position of a point of interest in a patient anatomical area with a first navigation device; inserting a medical device in the patient area; and navigating the medical device according to the position using a second navigation device integrated with the medical device, wherein navigating is done without requiring fluoroscopy or in vivo visualization.

14. The method of claim 13, further comprising: collecting navigation data in real time with the second navigation device integrated with the medical device; and adjusting navigation of the medical device in real time according to the collected navigation data15. The method of claim 13, wherein recording a position of a point of interest in a patient anatomical area comprises: directing sensing light distally along an optical fiber bundle with a fiber Bragg grating in the medical device; reflecting at least a portion of the sensing light from the fiber Bragg grating as reflected light; performing optical frequency domain reflectometry on the reflected light; and determining a location of the medical device based on the domain reflectometry.

16. The method of claim 13, wherein recording a position of a point of interest in a patient anatomical area comprises: producing rapidly changing magnetic fields around the medical device to induce an electrical current around an electromagnetic coil in the medical device; and calculating a location in Cartesian coordinates based on the electrical current.

17. The method of claim 13, wherein recording a position comprises generating a three- dimensional map of the patient anatomical area.

18. The method of claim 17, wherein generating the three-dimensional map comprises: collecting a plurality of signal data from one or more navigational components integrated with the medical device; integrating the plurality of signal data; and using machine learning to produce the three-dimensional map based on the plurality of signal data.

19. A method of mapping a target area in a patient, the method comprising: inserting a medical device into the patient near the target area, the medical device including an optical navigation system having at an optical fiber bundle and at least one fiber Bragg grating thereon; directing sensing light distally along the optical fiber bundle such that at least a portion of the sensing light reflects from the fiber Bragg grating as reflected light; performing optical frequency domain reflectometry on the reflected light; and determining a location of the target area based on the optical frequency domain reflectometry.

20. The method of claim 19, further comprising: producing rapidly changing magnetic fields around the medical device to induce an electrical current around an electromagnetic coil; and calculating a location in Cartesian coordinates based on the electrical current.

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