Shock wave catheter for the treatment of sinusitis

Abstract

A method for treating a narrowed region of a lumen in a patient's ear or nose is described herein. The method includes advancing a catheter within the lumen such that a distal end of the catheter is positioned proximate the narrowed region, filling a fillable member to cause the fillable member to expand within the lumen, and generating at least one shockwave from at least one shockwave emitter. The at least one shockwave creates one or more fractures in a bone structure of the narrowed region of the lumen that causes the narrowed region to expand.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and benefit to U.S. non-provisional patent application No. 18 / 620,583, filed March 28, 2024, and U.S. provisional patent application No. 63 / 456,272, filed March 31, 2023, the entire contents of each of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to the field of medical devices and methods, and more specifically, to catheter devices for treating narrowed areas of a patient’s ear or nose lumen and methods of using such devices. Background Technology

[0004] Chronic sinusitis is a common condition characterized by chronic inflammation and / or infection of the nasal passages and sinuses. Sinusitis can be caused by infection, allergies, hyperactive mucous membranes, sinus growth, and / or anatomical problems that impede normal drainage of the nasal cavity and sinuses. Symptoms of sinusitis may include nasal discharge or congestion, facial redness, pain or pressure around the eyes, cheeks, nose, or forehead, and decreased sense of smell and / or taste. A patient may be diagnosed with chronic sinusitis when sinusitis symptoms persist for 12 weeks or longer.

[0005] Chronic sinusitis can significantly negatively impact a patient's quality of life. There are various treatment options for chronic sinusitis. Corticosteroids, administered orally, via nasal sprays, or by injection, can relieve inflammation; however, long-term use of these steroids can lead to serious side effects. While oral medications are widely available, they can take a long time to take effect and may have negative side effects. Nasal sprays and injections may provide more direct relief; however, these methods lack proper patient compliance and may not reach the intended target area, such as deep within the ear or sinuses.

[0006] Chronic sinusitis can also be treated surgically. Endoscopic sinus surgery involves surgical resection to remove part of the patient's anatomical structures, thereby creating a drainage pathway. This may include removing sinus polyps and / or removing normal anatomical features such as a portion of the ostiomeatal complex to create a drainage pathway. Another available surgical option is balloon sinusoplasty. In balloon sinusoplasty, a catheter with a non-compliant inflatable balloon inflates in a narrowed area to dilate the blocked sinus, then pressurizes it to 8 to 18 atmospheres (8-18 atm). As the pressure increases, the energy stored in the balloon increases, eventually breaking down the bone structures in the patient's sinuses to create a sinus passage. Balloon sinusoplasty is anatomically gentler than surgical resection and better preserves the mucociliary function of the sinuses. However, the high pressure required to enable the balloon to destroy the bone structures in the sinuses can damage soft tissues, such as the mucosa, and prolong the postoperative healing period. Furthermore, if the balloon inflation fails to destroy the bone structures, additional endoscopic surgery may be required to successfully widen the blocked sinuses. Summary of the Invention

[0007] This article discloses a shockwave catheter device for treating narrowed areas of the lumen within a patient's ear or nose, and methods of using such a device. The shockwave catheter device uses shock waves to break up bone structures in the narrowed area to restore proper drainage while minimizing damage to soft tissue. Furthermore, the shockwave catheter device can utilize a low-pressure compliant or semi-compliant balloon with a directional shock wave emitter, allowing surgeons to selectively treat different areas of the narrowed region using location-specific shock waves. Compared to existing balloon sinusopexy methods, this shock wave delivers a higher peak pressure, enabling treatment of deeper areas within the tissue and allowing for long-term luminal patency.

[0008] In one aspect, this document discloses an exemplary method for treating a narrowed region of a lumen within a patient's ear or nose. The method includes advancing a catheter within the lumen such that a distal end of the catheter is positioned near the narrowed region. The distal end of the catheter includes at least one shock wave emitter surrounded by a fillable member. The method further includes filling the fillable member to expand it within the lumen. The method also includes generating at least one shock wave from the at least one shock wave emitter. The at least one shock wave creates one or more cracks in the bone structure of the narrowed region of the lumen, thereby expanding the narrowed region.

[0009] In some aspects, the method includes flushing the lumen, causing one or more bodily fluids to drain from the lumen through an expanded, narrowed region. In another aspect, the method includes adjusting the directionality of the at least one shock wave emitter before generating the one or more shock waves, such that the at least one shock wave is directed at the bone structure. In some aspects, adjusting the directionality of the at least one shock wave emitter includes rotating the catheter within the lumen about a central axis of the catheter. In several other aspects, adjusting the directionality of the at least one shock wave emitter includes adjusting an external knob on the catheter to rotate the catheter within the lumen about a central axis of the catheter. In several further aspects, adjusting the directionality of the at least one shock wave emitter includes adjusting the catheter such that an external indicator is oriented in a desired direction. In another aspect, the inflatable member includes a compliant balloon or a semi-compliant balloon. In another aspect, inflating the inflatable member includes pressurizing the inflatable member to a pressure of less than 10 atmospheres. In one aspect, inflating the inflatable member includes pressurizing the inflatable member to a pressure of up to 6 atmospheres. In some aspects, the method includes increasing the diameter of a lumen within a patient's ear or nose by pressurizing the inflatable member to a pressure of up to 10 atmospheres after generating the at least one shock wave. In some aspects, the method includes: at least partially collapsing the inflatable member; further advancing the catheter within the lumen such that a distal end of the catheter is positioned near a different portion of the narrowed region or a further narrowed region; filling the inflatable member to expand it within the lumen; and generating at least one shock wave from the at least one shock wave emitter, the at least one shock wave creating one or more fissures in the further narrowed region of the lumen to expand the further narrowed region. In another aspect, advancing the catheter within the lumen includes advancing the catheter on a guidewire. In yet another aspect, the lumen is part of the frontal sinus, maxillary sinus, sphenoid sinus, ethmoid sinus, sinus ostium, inferior turbinate, middle turbinate, superior turbinate, nasal cavity, ostiomeatal complex, or a combination thereof. In another aspect, the method includes locating the narrowed region using an imaging sensor of the catheter before generating the at least one shock wave. In some aspects, the method includes: advancing an endoscope within the lumen such that the distal end of the endoscope is offset / displaced proximally from the distal end of the catheter; and obtaining one or more images of the distal end of the catheter to locate the narrowed region. In another aspect, the at least one shock wave delivers a therapeutically effective amount of an active agent of a drug into the lumen. In one aspect, the active agent may include a corticosteroid. In another aspect, the active agent includes an antibiotic. In some aspects, the drug layer on the fillable member may include an active agent and one or more adjuvants.

[0010] In another aspect, this document discloses a device for treating a narrowed area of ​​a lumen within a patient's ear or nose. The device includes an elongated tube, at least one shock wave emitter, at least one imaging sensor, and a fillable member. The at least one shock wave emitter is configured to generate at least one shock wave along an operating direction. The at least one imaging sensor is oriented to capture images along the operating direction. The fillable member is hermetically connected to the distal end of the elongated tube and surrounds the at least one shock wave emitter and the at least one imaging sensor. The fillable member may be filled with a conductive fluid. In some aspects, the fillable member includes a drug coating, and the at least one shock wave delivers a therapeutically effective amount of the drug active agent into the lumen. Attached Figure Description

[0011] The illustrative aspects of this disclosure are described in detail below with reference to the accompanying drawings. The embodiments and drawings disclosed herein are intended to be illustrative and not restrictive.

[0012] Figure 1 A system comprising an exemplary shockwave catheter device for treating narrowed regions within a body lumen is shown, according to one or more aspects of this disclosure.

[0013] Figure 2A-2C A shockwave catheter device for treating excessive mucus in a patient's frontal sinus is shown according to one or more aspects of this disclosure.

[0014] Figure 3A and Figure 3B A side view of the distal end of an exemplary shockwave catheter device for treating a narrowed area inside a patient's ear or nose, according to one or more aspects of this disclosure, is shown.

[0015] Figure 3C One or more aspects of this disclosure are shown. Figure 3A and 3B A cross-sectional view of the slender tube of the conduit device.

[0016] Figure 3D The illustration depicts one or more aspects according to this disclosure. Figure 3A and 3B A directional cross-sectional view of the transmitter of the conduit device.

[0017] Figure 4 A method for treating a narrowed area of ​​a patient’s ear or nasal cavity is shown according to one or more aspects of this disclosure.

[0018] Figure 5 An exemplary computing device according to one or more aspects of this disclosure is shown. Detailed Implementation

[0019] The following description is intended to enable those skilled in the art to make and use the various embodiments disclosed herein. The descriptions of specific apparatuses, components, techniques, and applications are provided by way of example only. Various modifications to the examples described herein will be apparent to those skilled in the art, and the general principles described herein can be applied to other examples and applications without departing from the spirit and scope of the various embodiments. Therefore, the various embodiments are not intended to be limited to the examples described and illustrated herein, but are accorded the scope consistent with the claims.

[0020] This document describes a shockwave catheter device for treating narrowed areas of a patient's ear or nose lumen and a method of using such a device. The catheter device may include at least one shockwave emitter having at least one electrode pair configured to generate one or more shock waves. As used herein, the term "electrode" refers to a conductive element (typically made of metal) that receives current and subsequently releases it to another conductive element. In the context of this disclosure, electrodes are typically positioned adjacent to each other, for example, in an arrangement of inner and outer electrodes. Thus, as used herein, the term "electrode pair" refers to two electrodes positioned adjacent to each other such that applying a sufficiently high voltage to the electrode pair will cause current to travel across the gap between the two electrodes (also called a "spark gap") (e.g., from the inner electrode to the outer electrode, or, alternatively, through a conductive fluid or gas therebetween). In some cases, one or more electrode pairs (positioned across one or more emitters) may also be referred to as an electrode assembly. In the context of this disclosure, the term "emitter" generally refers to the region of the electrode assembly in which current travels across the electrode pair and thus generates a shock wave. The term "emitter strip" refers to a strip made of conductive material that can form one or more electrodes of one or more electrode pairs, thereby forming the location of one or more emitters.

[0021] A catheter device can be advanced within a patient's body lumen, positioning the distal portion of the device, which has one or more shock wave emitters, near a narrowed area of ​​the lumen to be treated. Voltage can then be applied to the one or more shock wave emitters to generate one or more shock waves that propagate outward and impact the narrowed area. As the shock waves impact the narrowed area, they can create one or more cracks in the bone structure of the narrowed area, thereby expanding it. Therefore, this catheter device can be used to relieve symptoms caused by narrowed areas such as those within the ear and / or nasal cavities.

[0022] In one or more examples, the shockwave emitter of the catheter device can be configured to generate shockwaves directed in a specific direction. During treatment, the orientation of the shockwave emitter can be adjusted such that the shockwave is directed to a specific area of ​​the patient's lumen. Therefore, a shockwave can be generated targeting a specific area without adversely affecting nearby areas. The area of ​​the patient's lumen being treated may include image data from one or more image sensors. For example, the catheter device may include an image sensor that captures image data of a working area corresponding to the area targeted by the shockwave emitter. Therefore, the orientation of the shockwave emitter can be adjusted based on image data from such a sensor to ensure that a specific area is affected by the shockwave and / or to target new areas for subsequent shockwave therapy.

[0023] In one or more examples, the catheter device may include an inflatable member (e.g., a balloon) that expands around a shock wave emitter to surround the emitter with a conductive fluid. This conductive fluid is capable of generating and propagating shock waves into the body's lumen. During treatment, the inflatable member can be pressurized to less than 10 atmospheres (10 atm), which is relatively gentle on the patient's anatomy compared to high-pressure balloons such as those used in balloon sinusopycosis. For example, during treatment, the inflatable member may be pressurized to approximately 4 atmospheres (4 atm) or approximately 6 atmospheres (6 atm). In some examples, after treatment, the inflatable member may be pressurized to up to 10 atmospheres (10 atm).

[0024] In one or more examples, the fillable member may have an external drug coating. The external drug coating can be released from the surface of the fillable member by a shock wave, such that the shock wave generated by the shock wave emitter delivers a therapeutically effective amount of the active pharmaceutical ingredient into the patient's lumen during treatment. Delivery of the active pharmaceutical ingredient into the lumen by one or more shock waves advantageously allows the active ingredient to penetrate deeper into the tissue than other methods of drug administration (e.g., nasal sprays or oral medications). On the surface of the fillable member, the drug coating may be in crystalline, amorphous, or a combination thereof. U.S. Patent Application No. 18 / 620,248 describes an example of using shock waves to bypass the blood-brain barrier (BBB) ​​and deliver a drug coated on the surface of a fillable member of a shock wave catheter to the central nervous system (CNS), the entire contents of which are incorporated herein by reference.

[0025] As described herein, it should be understood that any disclosure describing a range of dimensions or measurements such as thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc., includes any numerical increments or grades within the range mentioned for a given dimension or measurement. Furthermore, numerical indicators such as “first,” “second,” “third,” “fourth,” etc., are merely descriptive and do not indicate a relative order, position, or identity of the elements or features described by the indicator. For example, a “first” shock wave may be followed by a “third” shock wave, and then a “second” shock wave. As another example, a “third” transmitter can be used to generate a “first” shock wave, or vice versa. Therefore, the numerical indicators of various elements and features are not intended to limit this disclosure and can be modified and interchanged without departing from the invention.

[0026] In some embodiments, the catheter disclosed herein is a so-called “rapid-exchange” (“Rx”) catheter, having an opening through which a guidewire is guided (e.g., guided longitudinally through the middle portion of a central tube). In several other embodiments, the catheter may be an “online” (“OTW”) catheter, wherein a guidewire lumen is formed along the entire length of the catheter, and the guidewire is guided through the proximal end of the manipulator.

[0027] According to one or more aspects of this disclosure, Figure 1 The illustrated system 10 includes an exemplary shockwave catheter device 15 for treating a narrowed region 52 within a body lumen 50. The catheter device 15 includes a catheter body 12 extending between a proximal end 22 and a distal end 14 of the catheter device 15. The catheter device 15 can be introduced into the narrowed region within the lumen, for example, as... Figure 1 The narrowed region 52 of the frontal sinus is shown, and then one or more shock waves generated from the distal end 14 of the catheter device 15 are used to expand the narrowed region 52.

[0028] The distal end 14 of the catheter device 15 may include a fluid-fillable component, such as a compliant or semi-compliant balloon, surrounding at least one shock wave emitter 16, which may generate one or more shock waves to disrupt bone structures within the body lumen 50. Bone structures that can be disrupted by the pressure of the shock waves may include structures containing hard tissue (e.g., cartilage and / or rigid bone tissue), such as the nasal turbinates within the nose.

[0029] Shock wave emitter 16 includes one or more emitters that emit shock waves that propagate outward from the emitters. The emitters may include any suitable combination of electrodes forming an electrode pair separated by a fluid-filled gap. Applying a suitable voltage across the gap results in the formation of a plasma arc, which causes the expansion and collapse of cavitation bubbles, thereby generating a shock wave. The emitter may include one or more insulated wires with exposed portions (e.g., insulated wires with exposed areas where the insulator has been removed) and / or one or more conductive emitter strips (e.g., conductive metal sheaths) mounted around the conduit body 12.

[0030] During treatment, the proximal end 22 of the catheter device 15 remains outside the lumen 50 of the patient's body. The proximal end 22 may include a handle for the surgeon to grip. The proximal end 22 may include a fluid port 26 for filling and draining conductive fluid, such as saline, into and from the fillable member of the catheter device 15. In one or more examples, the conductive fluid may also include an X-ray contrast fluid to allow the surgeon to perform fluorescence observation of the catheter during use. The proximal end 22 may include an electrical connection port 24 providing an electrical connection between a shock wave emitter 16 and an external high-voltage pulse generator 28, such as... Figure 1 The generator is shown. In one or more examples, the proximal end 22 may include an inlet port for receiving a removable guidewire 20, which may assist in the insertion of the catheter device 15 into a body lumen during treatment. The guidewire 20 may include one or more imaging sensors connected to an imaging processor and / or a display, enabling the surgeon to visually locate the area to be treated. Additionally or alternatively, other areas of the guidewire 20 and / or catheter device 15 may include navigation sensors (e.g., radio frequency sensors, electromagnetic sensors, etc.) that operate in conjunction with a tracking system and software that indicate the position of the guidewire and / or catheter within the body lumen on a visual display.

[0031] The catheter body 12 may include a flexible hollow shaft or elongated tube, and may include internal conduit connecting the distal end 14 to the proximal end 22. For example, the catheter body 12 may include one or more wire lumens for carrying one or more insulated wires extending from the high-voltage pulse generator 28 to the shock wave emitter 16. The catheter body 12 may include one or more fluid lumens, such as fluid inflow lumens and fluid outflow lumens, for delivering conductive fluid from the fluid port 26 to the distal end 14 of the catheter device 15. The catheter body 12 may include a guidewire lumen sized to receive the guidewire 20. In one or more examples, the catheter body 12 has compliant material properties such that the catheter device 15 can be twisted, bent, and physically manipulated to maneuver the catheter device 15 to a treatment area within a body lumen.

[0032] The high-voltage pulse generator 28 can be used to control the amplitude of the shock wave generated by the shock wave emitter 16. For example, one or more of the amplitude, current, frequency, and / or duty cycle of the voltage pulse applied to the electrodes of the shock wave emitter 16 can be changed to adjust the amplitude of the generated shock wave. Although the shock wave device described herein is based on the generation of shock waves by a high voltage applied to the electrodes, it should be understood that the shock wave device may additionally or alternatively include a laser and an optical fiber as a shock wave emitter system, whereby the laser source transfers energy into the fluid through the optical fiber to form shock waves and / or cavitation bubbles.

[0033] The catheter device 15 may include at least one image sensor and / or at least one navigation sensor (not shown), which may be connected to an imaging processor such as processor 27, and / or an external display such as display 31. Processor 27 may process data captured by the image sensor or transmitted by the navigation sensor to display one or more images or perspective / renderings on display 31 during shockwave therapy. These images and / or renderings may be used to position the distal end 14 of the catheter device 15 in a narrowing region before generating the shockwave, and / or to orient the distal end 14 of the catheter device 15, for example, to orient the distal end 14 such that the generated shockwave propagates in a specific direction.

[0034] In one or more examples, the proximal end 22 of the catheter device 15 may include a control knob 23 and / or an indicator 25 for adjusting the directionality of the distal end 14 of the catheter device 15. A surgeon can use the control knob 23 to rotate the distal end 14 of the catheter device 15 within the patient's lumen. For example, a surgeon can rotate the control knob 23 counterclockwise to rotate the catheter device 15 accordingly. The indicator 25 may represent the direction in which the shock wave emitter 16 of the distal end 14 faces (e.g., the direction in which the shock wave will travel as it propagates outward from the shock wave emitter 16). Thus, a surgeon can utilize the control knob 23 and / or the indicator 25 to orient the distal end 14 so that the shock wave impacts a specific area of ​​the patient's lumen. The control knob 23 or other user controller can be used to manipulate the distal end 14 of the catheter device 15, which may be configured to bend relative to the proximal portion of the catheter body 12. The ability to manipulate the distal end 14 of the catheter device 15 is useful for positioning the distal end 14 of the catheter device 15 near a target treatment area within a large body lumen. For example, for relatively large body lumens, such as Figure 1 The distal end 14 of the catheter device 15 shown in the frontal sinus can be manipulated within the frontal sinus such that the shock wave emitter 16 is positioned to target treatment areas adjacent to the frontal sinus (or positioned at a desired distance from the target treatment area).

[0035] In one or more examples, system 10 may include an imager, such as an endoscopic imager 29, for locating and / or orienting the distal end 14 within the lumen. For example, the endoscopic imager 29 may advance within the lumen and acquire imaging data of the distal end 14 of the intraluminal catheter device 15, which the surgeon can use to locate the narrowed area to be treated and / or monitor treatment of the lumen while generating a shock wave. As both the endoscopic imager 29 and the catheter device 15 advance within the patient's lumen, the distal end of the endoscopic imager 29 may be positioned such that it is offset proximally relative to the distal end 14 of the catheter device 15 (e.g., ...). Figure 1 (As shown). This configuration allows the endoscopic imager 29 to capture imaging data of the distal end 14 of the catheter device 15.

[0036] System 10 can be used to expand narrowed areas within a patient's ear or nose. For example, Figure 2A –2C describes a shockwave catheter system for treating excessive mucus in the frontal sinuses of patients. Specifically, Figure 2A The sinuses of a patient with excess mucus 32 in the frontal and maxillary sinuses are depicted. This accumulation can be improved by dilating the treatment area 30 to allow the excess mucus 32 to drain through the patient's sinus passages. For this purpose, a catheter device 35, such as... Figure 1 The catheter device 15 can be advanced within the patient's sinuses, such that the catheter device 35 is located within the treatment area 30, as... Figure 2B As shown. The infillable member of the catheter device 35 can then be filled with conductive fluid to expand the infillable member within the treatment area 30. The catheter device 35 can then be used to generate one or more outwardly propagating shock waves. As the shock waves propagate outward, they impact the bone structure of the patient's sinuses, thereby creating small fractures in the bone structure, causing the treatment area 30 to expand. When the catheter device 35 is removed, as... Figure 2C As shown, the treatment area 30 can be held in an expanded position, allowing excess mucus 32 to drain. Optionally, when mucus is present in the treatment area 30 (e.g., covering the treatment area), the expansion of the fillable member can displace at least some of the mucus from the path between the catheter device 35 and the treatment area 30, preventing the shock wave from traveling through (or through so much) the mucus to reach the treatment area 30. In at least some cases, the expansion of the fillable member is sufficient to completely displace the mucus, allowing the fillable member to contact at least a portion of the tissue in the treatment area 30. Displacing the mucus away from the path of the catheter device 35 and the treatment area 30 increases the effectiveness of the treatment because there is less (or no) mucus to dissipate the energy of the shock wave.

[0037] Figure 3A and 3BA side view of the distal end of an exemplary shockwave catheter device 300 for treating a narrowed area within a patient's ear or nose, according to one or more aspects of this disclosure, is shown. The catheter device 300 can be used in systems for treating narrowed areas within a patient's ear or nose, such as… Figure 1 In system 100, the conduit device 300 includes a fillable member 304 that is sealed to an elongated tube 302. Figure 3A A fillable member 304 in a filled state is shown, while Figure 3B The fillable component 304 in an unfilled state is shown. Within the fillable component 304, the conduit assembly 300 includes a pair of transmitter assemblies 305, 306 connected to the distal end of at least one wire (not shown). The conduit assembly 300 also includes a flushing lumen 325 and an image sensor 310.

[0038] As described above, the elongated tube 302 may include one or more internal conduits that connect components at the distal end of the conduit assembly 300 to external components such as voltage sources and / or fluid sources. Examples of such internal conduits are... Figure 3C The diagram shows this more clearly. Figure 3A and 3B A cross-sectional view of the elongated tube 302. Within the elongated tube 302 are two wires 307 and 308, two fluid lumens 317 and 318, and a guidewire lumen 319. The proximal ends of wires 307 and 308 can be connected to a pulse voltage source, for example... Figure 1 The high-voltage pulse generator 28 allows lines 307 and 308 to supply voltage to the shock wave emitter assemblies 305 and 306. The guidewire lumen 319 can receive the guidewire used for positioning the catheter device 300, for example... Figure 1 The guide wire 20. Fluid lumens 317 and 318 can deliver conductive fluid to the distal end of the conduit assembly 300, which can be used to fill the fillable member 304.

[0039] Shock wave emitter assemblies 305 and 306 are configured to generate a shock wave in response to a voltage pulse transmitted through at least one line 307 or 308. For example, when a voltage is applied to shock wave emitter assemblies 305 and / or 306, small bubbles are generated around the electrodes to insulate them. Each shock wave emitter assembly has at least one electrode pair, the electrode pair having electrodes separated from each other by a gap and surrounded by a conductive fluid. Subsequently, a plasma arc is formed across the gap between the electrodes of the electrode pair, thereby creating a low-impedance path for free current flow. Heat from the plasma arc heats the conductive fluid to generate rapidly expanding vapor bubbles. The expansion and collapse of the vapor bubbles generate a shock wave propagating outward from the shock wave emitter.

[0040] One or more shock wave emitter assemblies 305, 306 can be configured to generate shock waves that propagate outward in a specific direction. For example, in Figure 3A In the example shown, shock wave emitter assembly 305 includes electrode pair 315 configured to generate a shock wave that radiates outward in the direction indicated by arrow A1 (e.g., upward relative to the indicated orientation). Conversely, shock wave emitter 306 includes electrode pair 315 configured to generate a shock wave that radiates outward in a direction circumferentially offset by 90 degrees relative to arrow A1 (e.g., orthogonal or "off-page").

[0041] As a shock wave radiates outward, the pressure from the shock wave impacts the surrounding tissues within the body's cavities. A given shock wave pressure can radiate in multiple directions. Nevertheless, a specific direction in which the shock wave emitter is oriented (e.g., the direction of arrow A1 for shock wave emitter assembly 305) can correspond to the highest amplitude portion of the shock wave. For example, although shock waves emitted from shock wave emitter assembly 305 generally propagate in the direction indicated by arrow A1 (with some deviations in other directions), the highest amplitude portions of these shock waves can still propagate in the direction of arrow A1.

[0042] Figure 3D One or more aspects of this disclosure are shown. Figure 3A and 3B A directional cross-sectional view of the transmitter assembly 305 of the catheter device 300. The transmitter assembly 305 is depicted as being located within a patient's body lumen 352. The electrode pair 315 includes the transmitter assembly 305 and the distal end 309 of a wire 308. When a voltage is applied to the wire 308, current can flow through the gap between the distal end 309 of the wire 308 and the transmitter assembly 305 to generate one or more shock waves. The shock waves will propagate toward a treatment area 350 of the body lumen 352. That is, the transmitter assembly 305 is configured such that at least the highest amplitude portion of the shock wave propagates toward the treatment area 350. In particular, opposite sides of the body lumen 352 are not affected by the shock waves propagating toward the treatment area 350. Therefore, the catheter device 300 can be used to treat specific areas of a patient's body lumen without treating other areas. For example, this can be useful if a surgeon wants to treat one side of a patient's body lumen and / or does not want to treat certain areas of the patient's body lumen. As shown in the figure, the surgeon can generate a shock wave that impacts the treatment area 350 but not the opposite side of the body lumen. In the case of sinus anatomy, the treatment area 350 can be the bony structure beneath the frontal, ethmoid, maxillary, or sphenoid sinus tissue, while the body lumen 352 can be the nasal septum. Conversely, if applied to septoplasty, the shock wave can be directed towards the nasal septum to help prepare it for trimming, repositioning, and / or replacement of the anatomical structure.

[0043] The distal end of the catheter assembly 300 may be rigid, thereby allowing adjustment of the directionality of the shock wave emitter by rotating the catheter assembly 300 about its central axis A. In one or more examples, the proximal end of the catheter assembly 300 may include a knob, for example... Figure 1 The control knob 23 can be used to rotate the distal end of the catheter assembly 300. The proximal end of the catheter assembly 300 may also include a direction indicator, such as... Figure 1 The surgeon can use indicator 25 to adjust the direction of the shock wave emitter. For example, the surgeon can adjust the proximal end of the catheter device 300 so that the direction indicator is oriented in the desired direction. In some examples, the user can simply rotate the entire device via a handle to change the direction of the shock wave emitter.

[0044] Back Figure 3A The conduit device 300 includes a pair of shock wave emitter assemblies 305 and 306. However, this is provided by way of example only, and the conduit device 300 may include a single shock wave emitter or more than two shock wave emitters, such as three, four, five, six, etc. In the case where the conduit device 300 includes multiple shock wave emitters, these shock wave emitters may be configured to generate shock waves propagating outward in the same direction or to generate shock waves propagating outward in different directions (e.g., as shown with respect to shock wave emitter assembly 305 and shock wave emitter 306).

[0045] When the catheter device 300 includes multiple shock wave emitters, these emitters may be longitudinally close to each other so that the shock waves generated by the emitters constructively interfere with each other, as described in U.S. Patent Application No. 16 / 967,544, which is incorporated herein by reference. Furthermore, shock wave emitter assemblies 305, 306 may include a single electrode pair or multiple electrode pairs. As described in the foregoing references, when the shock wave emitter includes multiple electrode pairs, these pairs may be circumferentially close to each other so that the shock waves generated at the electrode pairs constructively interfere with each other. For example, shock wave emitter assembly 305 may include multiple electrode pairs that are circumferentially offset / misaligned with each other along the emitter. Further details and embodiments of such electrodes, electrode assemblies, and emitters are disclosed in U.S. Patent Nos. 8,888,788 and 10,709,462 and U.S. Publication No. 2021 / 0085347, all of which are incorporated herein by reference.

[0046] The inflatable member 304 may be a flexible member, such as a compliant or semi-compliant balloon, configured to at least partially inflate in response to being filled with a conductive fluid (e.g., water or saline). The inflatable member 304 may be formed of any suitable material that allows the member to stretch or contract with changes in fluid pressure within the member (e.g., in response to filling or draining the member with fluid). For example, the inflatable member 304 may be formed of an elastic material such as nylon, polyamide, polyurethane, etc. In one or more examples, the inflatable member 304 may be formed of a material that does not experience elastic stretching or contraction with changes in fluid pressure within the member, such as a material suitable for a non-compliant balloon. The inflatable member 304 may include multiple layers, which may include any combination of these materials, such as a polyamide inner layer and a nylon outer layer. The inflatable member 304 may include a working length corresponding to a distance d extending between the tapered regions of the member. In one or more examples, the working length may be in the range of ten millimeters to seventy millimeters (10-70 mm), or greater than seventy millimeters (70 mm).

[0047] Figure 3B The figure depicts a fillable member 304, which is in an unfilled state. As shown, relative to... Figure 3A The fillable member 304, in its unfilled state, has a small diameter. In one or more examples, the diameter of the fillable member 304 after being filled with conductive fluid can range from 3 mm to 40 mm (3-40 mm), or greater than 40 mm (40 mm). When fully filled, the diameter of the fillable member 304 can range from about 3-40 mm, about 10-40 mm, about 20-40 mm, and any increments and grades of diameter within these ranges. Variations / variations of the fillable member 304 can be determined based on the patient's target anatomy. For example, a catheter device 300 with a larger fillable member 304 can be used for a larger body lumen, while a catheter device 300 with a smaller fillable member 304 can be used for a smaller body lumen. Similarly, the length of the fillable member 304 can vary for different target anatomy. Exemplary ranges of the length of the fillable member 304 include about 10-1000 mm, about 10-500 mm, about 20-100 mm, and any increments and grades of length within these ranges. Physicians can obtain a variety of different variations of the catheter device 300 with different sizes, and can select a variation with a suitable combination of sizes (e.g., diameter and length) of the fillable component 304 based on patient characteristics such as age, sex, disease, anatomical limitations, etc.

[0048] The catheter device 300 may include one or more lumens for filling the fillable member 304 (e.g., Figure 3CThe fluid conduits 317 and 318 may be, for example, inflow and outflow conduits, or a single fluid conduit. Discharging fluid from the fillable member 304 may be described as deflated, which may include completely or at least partially deflated. Alternatively, if the fillable member 304 does not undergo elastic stretching or contraction, discharging fluid from the fillable member 304 may include removing fluid from within the fillable member 304 without significantly altering the member's diameter.

[0049] The fillable member 304 may include an external drug coating 312. The external drug coating 312 can be released from the member by a shock wave, such that the shock wave generated by the shock wave emitter 306 delivers a therapeutically effective amount of the active pharmaceutical ingredient into the lumen during treatment. Delivering the active pharmaceutical ingredient (crystalline or amorphous form, or a combination thereof) into the lumen by one or more shock waves advantageously allows the active pharmaceutical ingredient to penetrate deeper into the tissue than other methods of drug administration, such as nasal sprays or oral medications.

[0050] The external drug coating 312 may comprise a plurality of microspheres or microcapsules of an active agent, or an active agent layer bonded to the outer surface of the fillable member 304. The active agent may comprise corticosteroids such as prednisolone, methylprednisolone, beclomethasone dipropionate, triamcinolone acetonide, flunisolone, budesonide, fluticasone propionate, mometasone furoate, cisacinone, fluticasone furoate, betamethasone sodium phosphate, or any combination thereof. The active agent may comprise antibiotics such as amoxicillin / clavulanic acid, trimethoprim-sulfamethoxazole, fluoroquinolones, ciprofloxacin, cefuroxime axetil, roxithromycin, quinolones, or any combination thereof. In one or more examples, the external drug coating 312 may contain one or more adjuvants such as antifungal agents, anti-immunoglobulin E (anti-IgE), anti-interleukin-5 (anti-IL5), antihistamines, aspirin, bacterial lysates, capsaicin, decongestants, furosemide, immunosuppressants, leukotriene antagonists, nasal irrigators, mucolytics, probiotics, proton pump inhibitors, piracetam, mepolizumab, or any combination thereof.

[0051] The catheter device 300 may include an irrigation lumen 325 for flushing a patient's lumen during treatment. For example, after dilating a narrowed region of the lumen, an irrigation fluid (e.g., saline or water) may be introduced into the lumen to facilitate the drainage of any excess mucus remaining in the lumen through the dilated region. In one or more examples, the fillable member 304 may be at least partially deflated before the irrigation fluid is introduced via the irrigation lumen 325. Alternatively, the fillable member 304 may remain filled when the irrigation fluid is introduced.

[0052] In one or more examples, the conduit device 300 may include at least one image sensor 310, which can be connected to an external image processing device and / or display, for example... Figure 1 The processor 27 and / or display 31 are included. An image sensor 310 may be located near the shock wave emitter 306 and may be configured to acquire image data of the working area from which the shock wave propagates outward from the shock wave emitter 306. For example, as described above, one or more shock wave emitters 306 may be configured to propagate the shock wave along a specific direction (e.g., the working direction), and the image sensor 310 may be configured to capture image data of an intraluminal region along that direction. The image data from the image sensor 310 can be used to position the catheter device 300 near a narrowed region within the lumen, such that the shock wave generated from the shock wave emitter 306 impacts an area of ​​the narrowed region with fracturable bone structure, thereby expanding the narrowed region.

[0053] In one or more examples, the distal end of the conduit device 300 may include one or more position sensors 330. The position sensors 330 may provide position data to one or more external sensors or receivers (e.g., as part of a navigation system). Data from the position sensors 330 and one or more external sensors may be provided to an external processor (e.g., ...). Figure 1 The external processor 27 can track the movement of the distal end of the catheter device 300 within the patient's lumen. For example, a surgeon can perform a pre-treatment mapping procedure (e.g., a calibration procedure) to map the patient's anatomy within the lumen of the ear and / or nose, and then use that mapping and location data to monitor the movement of the catheter device 300 during treatment.

[0054] Figure 4 This invention describes a method 400 for treating a narrowed area of ​​a patient's ear or nasal cavity according to one or more aspects of this disclosure. Method 400 can be implemented using a system with a shock wave catheter device, such as... Figure 1 System 10 and Figure 3A The catheter device 300. Method 400 can be used to treat narrowed areas in the lumen of the frontal sinus, maxillary sinus, sphenoid sinus, ethmoid sinus, sinus ostium, turbinate (e.g., inferior, middle, or superior turbinate), nasal cavity, ostiomeatal complex, or any combination thereof. Method 400 can be used to treat narrowed areas in the lumen of the Eustachian tube, external auditory canal, or middle ear.

[0055] In one or more examples, method 400 may begin at box 402, wherein a catheter device is advanced into a lumen of the patient's ear or nose such that the distal end of the catheter device is positioned near a narrowing region within the lumen. For example, returning to... Figure 2A and Figure 2B The treatment area 30 is part of the patient's frontal sinus canal. Figure 2BA catheter device 35 is depicted positioned near the treatment area 30 of the lumen (after the fillable component has been “expanded” or filled with conductive fluid).

[0056] In one or more examples, advancing the catheter device within the lumen allows data from one or more sensors to be utilized at the distal end near the narrowing region. For example, imaging sensors from the catheter device (e.g., Figure 3A The image sensor 310 provides data to locate the narrowing region. This data is processed by an external processing device to display one or more images and / or videos as the catheter device advances within the lumen. The surgeon can utilize these images and / or videos while advancing the catheter device within the lumen to position the distal end near the narrowing region. The distal end of the catheter device may include one or more position sensors (e.g., [image sensor 310]). Figure 3B The position sensor 330 provides data to one or more external sensors outside the patient (e.g., around the patient's head), which can be processed by an external processor to track the movement of the catheter device within the lumen.

[0057] In one or more examples, the catheter device may be advanced within a lumen on a guidewire. The catheter device may include a lumen for receiving the guidewire, and the guidewire may advance within the lumen to locate the narrowing region before advancing the catheter device into the lumen to position the distal end of the catheter device near the narrowing region. The guidewire may include an imaging sensor near its distal end, which can be used to locate the narrowing region as described above. As the catheter device advances within the lumen, data from the imaging sensor is processed by an external processing device to display one or more images and / or videos.

[0058] In one or more examples, a single endoscope may be advanced within the lumen. The endoscope may include an imaging sensor configured to provide imaging data that can be displayed on an external display for use by the surgeon during a shockwave procedure. This imaging data can be used, for example, to position the distal end of the catheter device near the narrowed area to be treated. For example, the endoscope may be advanced within the lumen such that the distal end of the endoscope is deflected / misaligned proximally from the distal end of the catheter device (e.g., Figure 1 (As shown). This configuration allows the endoscope to capture imaging data of the distal end of the endovascular catheter device, which can be used to position the distal end of the catheter device near the narrowing region. Therefore, after positioning the endoscope to offset proximally from the catheter device, the endoscope can obtain one or more images of the distal end of the catheter device, which can be displayed to the surgeon.

[0059] In block 404, a fillable member of the conduit device is filled to cause the fillable member to expand within the lumen. The fillable member may be filled with a conductive fluid, such as water or brine, capable of conducting electric current, for example, between the electrodes of an electrode generator. As described above, the fillable member may be compliant or semi-compliant, such that filling the member causes the member to expand. Alternatively, the fillable member may be non-compliant, such that filling the member does not cause the member to expand, or nominally expands.

[0060] In one or more examples, filling a fillable member may include pressurizing the fillable member. Pressurizing the fillable member may include via a fluid port (e.g., Figure 1 fluid port 26 and / or Figure 3C Fluid (e.g., saline, water, or saline mixed with an imaging contrast agent) is introduced through one or both lumens 317 and 318, thereby allowing the fillable member to expand and thus pressurizing the fillable member to a desired pressure. In one or more examples, filling the fillable member may include pressurizing the fillable member to a pressure of less than ten atmospheres (10 atm). In one or more examples, filling the fillable member may include pressurizing the fillable member to a pressure of less than five atmospheres (5 atm). For example, the pressure may be in the range of about one atmosphere to about five atmospheres (1-5 atm).

[0061] In block 406, at least one shock wave is generated to create one or more cracks in the narrowed region, thereby expanding the narrowed region. Generating the shock wave may include, for example, by... Figure 1 A high-voltage pulse generator 28 applies one or more voltage pulses to the shock wave emitter of the conduit assembly. Each voltage pulse ionizes / ionizes the conductive fluid within the fillable component to generate small bubbles around the shock wave emitter, insulating its electrodes. Subsequently, a plasma arc forms across the gap between the electrodes of the electrode pair, creating a low-impedance path for free current flow. Heat from the plasma arc heats the conductive fluid to generate rapidly expanding vapor bubbles. The expansion and collapse of these vapor bubbles generate shock waves propagating outward from the shock wave emitter.

[0062] As shock waves propagate outward from the shock wave emitter, these shock waves strike the tube walls. For example, returning to... Figure 2BShock waves generated from the distal end of the conduit device 35 impact the wall of the frontal sinus, which can create one or more fissures in the bony structure of the frontal sinus. By creating fissures in the bony structure, the lumen can freely expand based on the diameter of the fillable member (e.g., expandable to the diameter of the "expanded" member). Therefore, the shock waves can be used to dilate the lumen, which facilitates the proper drainage of fluids or mucus previously trapped within the body lumen due to narrowing of the region. In one or more examples, these shock waves can be used to dilate the region, for example, to dilate... Figure 2A Treatment area 30. Alternatively, these shockwaves can be used to treat ruptured anatomical structures in patients, such as impacting the base of hook-shaped protrusions (e.g., Figure 2C (As shown), until the hook-shaped projection separates from the maxillary sinus. In another alternative embodiment, the hook-shaped projection may be weakened by the shock wave, causing it to compress or fold in a direction that facilitates proper drainage of fluid or mucus, while remaining attached to the internal sinus anatomy. In one or more examples, the shock wave may break, rupture, and / or otherwise treat the nasal septum. In one or more examples, as a supplement or alternative to the use of the shock wave to dilate and / or rupture the patient's anatomy, the diameter of the lumen may be expanded or increased by pressurizing the inflatable member to pressures up to 10 atmospheres (e.g., 4, 6, 8, or 10 atmospheres).

[0063] In one or more examples, the average pressure of the shock wave impacting the bone structure is in the range of 20 to 70 atmospheres (20-70 atm). For example, the pressure applied by the shock wave can be approximately 50 atmospheres (50 atm). Pressures within this range dissipate as they propagate further within the patient's anatomical tissue. Nevertheless, the pressure can advantageously reach deeper into the patient's tissues, rather than remaining on the surface, and not just confined to the area of ​​the fillable component adjacent to the catheter device. By generating shock waves that penetrate deeper into the patient's tissues, shock wave therapy can result in longer lumen openings. The amplitude and / or other characteristics of the shock wave can be controlled by adjusting the amplitude and / or duration of the applied voltage pulse. Embodiments of this disclosure can be achieved using voltages from approximately 2000 V to approximately 10,000 V and higher, as well as voltage increments and levels within these ranges (e.g., 2.60 kV, 3.70 kV, 4.80 kV, 5.90 kV, 7 kV, 8.2 kV, 9.5 kV, etc.). Similarly, the electrode assemblies and transmitters considered herein can be implemented using a variety of frequencies, including frequencies from about 1 Hz to about 4 Hz, from about 4 Hz to about 10 Hz, from about 10 Hz to about 50 Hz, and frequency increments and grades within these ranges. The amplitude and / or duration of the applied voltage pulse can be selected based on the anatomical structure being treated. For example, for denser anatomical structures, higher voltages and / or longer voltage pulse durations can be selected.

[0064] The characteristics of the shock wave can also be controlled by adjusting structural aspects of the electrode assembly, such as the distance between the electrodes of the electrode pair, the surface area of ​​the electrodes, and the shape of the electrodes. In some examples, the amplitude and / or other characteristics of the shock wave can be controlled for localized treatment by limiting the penetration depth, thereby protecting sensitive anatomical structures outside the treatment area 30. This can be achieved in various ways, such as by controlling the amplitude and / or frequency of the voltage pulse to generate a low-pressure shock wave, configuring the number and / or spacing of the shock wave emitters to limit the area impacted by the shock wave and / or limit the constructive interference of the shock wave, and configuring the spacing between the shock wave emitters and the infillable member so that the shock wave propagates further in the conductive fluid within the infillable member before impacting the treatment area 30.

[0065] In one or more examples, imaging data from an imaging sensor can be used to monitor treatment while the shock wave is being generated. For example, imaging data from an imaging sensor observing the same working area of ​​the shock wave propagation can be used to ensure that the shock wave impacts the intended area of ​​the lumen. In one or more examples, such imaging data can be obtained using an endoscope offset proximally from the distal end of the catheter device, allowing the endoscope to observe the effects of the shock wave from a proximal viewpoint.

[0066] In one or more examples, method 400 may include block 408, wherein flushing the lumen allows one or more bodily fluids to drain from the lumen via a dilated, narrowed region. For flushing the lumen, the catheter device may include a separate flushing lumen (e.g., Figure 3A and Figure 3B An irrigation lumen 325 is used to flush a patient's lumen with a fluid (such as water or saline) to allow bodily fluids to drain through a dilated, narrowed area. For example, flushing a lumen in the maxillary or frontal sinus can promote the drainage of excess mucus from that area, which can relieve symptoms of sinusitis.

[0067] In one or more examples, method 400 may include block 410, wherein the directivity of at least one shock wave emitter is adjusted. As described above, the catheter device may include one or more shock wave emitters configured to generate shock waves propagating outward in a particular direction. In one or more examples, adjusting the directivity at block 410 may include adjusting the directionality around the central axis of the catheter device (e.g., Figure 3A A) Rotation of the catheter device around its central axis. To rotate the catheter device around its central axis, the surgeon may utilize external control devices, such as… Figure 1Control knob 23. When adjusting the directionality of at least one shock wave emitter in box 410, the surgeon can utilize image data. For example, if the catheter device includes an image sensor that acquires image data of the working area where the shock wave propagates outward, the surgeon can use this image data to ensure that the depicted working area is the desired area where the shock wave of the lumen will strike. In one or more examples, the surgeon can utilize a separate endoscope with an image sensor and use data from the image sensor of the endoscope to adjust the directionality of the shock wave emitter of the catheter device. In one or more examples, box 410 can be performed before box 406, that is, the directionality of at least one shock wave emitter can be adjusted before the shock wave is generated, such that the shock wave is directed towards a specific area of ​​the patient's lumen.

[0068] In one or more examples, method 400 may include block 412, wherein different portions of the narrowed region or additional narrowed regions are treated. Treating different portions of the narrowed region may include rotating the catheter device as described above, such that a shock wave impacts a new portion of the lumen (e.g., opposite sides of the lumen). Treating the additional narrowed region may include repeating one or more steps of blocks 402, 404, 406, 408 and / or 410, and may include advancing the catheter device into the additional narrowed region, filling the infillable lumen, and generating at least one shock wave to create one or more fissures in the additional narrowed region. To advance the catheter device into the additional narrowed region, the surgeon may first drain fluid from the infillable member to reduce the outer diameter of the distal end of the catheter device, and then, after the distal end of the catheter device is positioned near the additional narrowed region, the surgeon may refill the infillable member.

[0069] Figure 5 An exemplary computing device 500 according to one or more examples of this disclosure is shown. Device 500 may be part of a system for treating a narrowed area of ​​a patient's ear or nasal cavity, such as... Figure 1 System 10. In one or more examples, device 500 is configured to process sensor input 514, such as from an image sensor (e.g., Figure 3A Image sensor 310) and / or imager (e.g. Figure 1 The system 10 uses image data from its endoscopic imager 29 to display image data to the surgeon for locating and / or orienting catheter devices to treat narrowed areas of the lumen. In one or more examples, sensor input 514 includes data from one or more position sensors (e.g., Figure 3BPosition data from position sensor 330 is used to locate and / or orient a catheter device within a lumen of a patient's ear or nose. In several other examples, sensor input 514 includes navigation data from one or more navigation sensors (e.g., radio frequency or electromagnetic sensors) that indicate the position of the guidewire and / or catheter within a body lumen on a visual display.

[0070] Device 500 can be a host connected to a network. Device 500 can be a client computer or a server. Figure 5 As shown, device 500 can be any suitable type of microprocessor-based device, such as a personal computer, workstation, server, or handheld computing device (portable electronic device) such as a telephone or tablet. The device may include, for example, one or more of a processor 502, an input device 506, an output device 508, a memory 510, and a communication device 504. Input device 506 and output device 508 can generally correspond to the aforementioned devices and can be connected to or integrated with a computer.

[0071] Input device 506 can be any suitable device from which input is provided by the device operator, such as a touchscreen, keyboard or keypad, mouse, or voice recognition device. Input device 506 can be additionally or alternatively configured to receive data stored on a separate or connected computerized device, wherein, in the case of sinus anatomy, such data may be, for example, patient-specific calibration or orientation data. Output device 508 can be any suitable device providing output, such as a touchscreen, haptic device, or speaker.

[0072] Memory 510 can be any suitable means of providing storage, such as electrical, magnetic, or optical memory, including random access memory (RAM), cache, hard disk, or removable storage disk. Communication device 504 may include any suitable means of transmitting and receiving signals over a network, such as a network interface chip or device. Computer components can be connected in any suitable manner, such as via a physical bus or wirelessly.

[0073] Software 512, which can be stored in memory 510 and executed by processor 502, may include, for example, a program embodying the functions of this disclosure (e.g., embodied in the aforementioned apparatus). Software 512 may also be stored and / or transmitted in any non-transitory computer-readable storage medium for use by or in connection with an instruction execution system, apparatus, or device (e.g., those described above), which may retrieve and execute instructions associated with the software from and execute such instructions. In the context of this disclosure, a computer-readable storage medium may be any medium, such as memory 510, which may contain or store programs used by or in connection with an instruction execution system, apparatus, or device.

[0074] Software 512 can also be propagated in any transmission medium for use by or in conjunction with an instruction execution system, apparatus, or device (such as those described above), which can retrieve and execute instructions associated with the software from and execute such instructions. In the context of this disclosure, the transmission medium can be any medium capable of transmitting, propagating, or transmitting a program used by or in conjunction with an instruction execution system, apparatus, or device. Transmission readable media can include, but are not limited to, electrical, magnetic, optical, electromagnetic, or infrared wired or wireless transmission media.

[0075] Device 500 can be connected to a network, which can be any suitable type of interconnected communication system. The network can implement any suitable communication protocol and can be protected by any suitable security protocol. The network may include any suitable network link capable of transmitting and receiving network signals, such as wireless network connections, T1 or T3 lines, cable networks, DSL, or telephone lines.

[0076] Apparatus 500 can implement any operating system suitable for running on a network. Software 512 can be written in any suitable programming language, such as C, C++, Java, or Python. In various different embodiments, application software embodying the functionality of this disclosure can be deployed in different configurations, such as in a client / server setup or as a web-based application or web service via a web browser.

[0077] While the catheter devices described herein may be discussed primarily in the context of treating coronary artery indications (such as vascular system diseases), they can be used for a wide range of indications. For example, similar designs can be used to treat soft tissues such as cancers and tumors (i.e., non-thermal ablation methods), blood clots, fibromas, cysts, organs, scars, and fibrotic tissue removal, or other tissue destruction and removal treatments. Catheter devices can be used for neurostimulation therapy, targeted drug delivery, treatment of intraluminal tumors (e.g., tumors in blood vessels, esophagus, intestines, stomach, or vagina), wound treatment, non-surgical removal and destruction of tissues, or as an alternative to thermal treatment or cauterization for venous insufficiency and tubal ligation (i.e., for permanent female contraception). Furthermore, the catheter devices described herein can also be used in tissue engineering methods, such as for mechanical tissue decellularization to produce bioactive scaffolds where new cells (e.g., exogenous and endogenous cells) replace old cells; introducing porosity to the site to improve cell retention, cell penetration / migration, and the diffusion of nutrients and signaling molecules, thereby promoting angiogenesis, cell proliferation, and tissue regeneration, similar to cell replacement therapy. This tissue engineering approach can be used to treat ischemic heart disease, fibrotic liver, fibrotic intestine, and traumatic spinal cord injury (SCI). For example, in the treatment of spinal cord injury, the devices and components described herein can facilitate the removal of scarred spinal cord tissue, acting as a barrier to neuronal reconnection, prior to the injection of an anti-inflammatory hydrogel loaded with lentiviruses to genetically engineer spinal cord neurons for regeneration.

[0078] It should be noted that the elements and features of the example catheters shown in this specification and accompanying drawings can be rearranged, recombined, and modified without departing from the present invention. The number, position, and spacing of the electrode pairs of the shock wave emitter can be modified without departing from the present invention. Furthermore, the number, position, and spacing of the catheter balloons can be modified without departing from the present invention.

[0079] It should be understood that the foregoing is for illustrative purposes only, and those skilled in the art can make various modifications, alterations, and combinations without departing from the scope and spirit of the invention. Any variation of the various catheter devices disclosed herein may include the features described in any other catheter device or combination of catheter devices herein. Furthermore, any method may be used with any of the disclosed catheter devices. Therefore, the invention is intended to be limited only by the appended claims.

Claims

1. A method for treating a narrowed area of ​​a lumen in a patient's ear or nose, the method comprising: A catheter is advanced within the lumen such that the distal end of the catheter is positioned near the narrowing region, the distal end of the catheter including at least one shock wave emitter surrounded by a fillable member. The fillable member is filled to cause it to expand within the lumen; and At least one shock wave is generated from the at least one shock wave emitter, the at least one shock wave generating one or more cracks in the bone structure of the narrowed region of the lumen, the cracks causing the narrowed region to expand.

2. The method of claim 1, further comprising flushing the lumen to allow one or more bodily fluids to drain from the lumen through an expanded, narrowed region.

3. The method of claim 1 or claim 2, further comprising adjusting the directionality of the at least one shock wave emitter before generating one or more shock waves, such that the at least one shock wave is directed at the bone structure.

4. The method according to claim 3, wherein, Adjusting the directionality of the at least one shock wave emitter includes rotating the catheter within the lumen about the central axis of the catheter.

5. The method according to claim 3 or claim 4, wherein, Adjusting the directionality of the at least one shock wave emitter includes adjusting an external knob on the conduit to rotate the conduit within the lumen about the conduit's central axis.

6. The method according to any one of claims 3-5, wherein, Adjusting the directionality of the at least one shock wave emitter includes adjusting the conduit so that the external indicator is oriented in the desired direction.

7. The method according to any one of the preceding claims, wherein, The inflatable component includes a compliant balloon or a semi-compliant balloon.

8. The method according to any one of the preceding claims, wherein, Filling the fillable component includes pressurizing the fillable component to a pressure of less than 10 atmospheres.

9. The method according to any one of the preceding claims, wherein, Filling the fillable component includes pressurizing the fillable component to a pressure of up to 6 atmospheres.

10. The method according to any one of the preceding claims, comprising: After generating the at least one shock wave, the diameter of the lumen in the patient's ear or nose is increased by pressurizing the inflatable member to a pressure of up to 10 atmospheres.

11. The method according to any one of the preceding claims, comprising: This causes the infillable member to deflate at least partially; The catheter is further advanced within the lumen so that the distal end of the catheter is positioned near a different portion of the narrowed region or another narrowed region. The fillable member is filled to cause it to expand within the lumen; and At least one shock wave is generated from the at least one shock wave emitter, and the at least one shock wave generates one or more cracks in the additional narrowing region of the lumen to expand the additional narrowing region.

12. The method according to any one of the preceding claims, wherein, Advancing the catheter within the lumen includes advancing the catheter on a guidewire.

13. The method according to any one of the preceding claims, wherein, The lumen is part of the frontal sinus, maxillary sinus, sphenoid sinus, ethmoid sinus, sinus ostium, inferior turbinate, middle turbinate, superior turbinate, nasal cavity, ostium-messuede complex, or a combination thereof.

14. The method according to any one of the preceding claims, comprising: Before generating the at least one shock wave, the narrowed region is located using an imaging sensor of the duct.

15. The method according to any one of the preceding claims, comprising: The endoscope is advanced into the lumen such that the distal end of the endoscope is displaced proximally relative to the distal end of the catheter; and Obtain one or more images of the distal end of the catheter to locate the narrowed region.

16. The method according to any one of the preceding claims, wherein, The at least one shock wave delivers a therapeutically effective amount of the active agent of the drug into the lumen.

17. The method according to claim 16, wherein, The active agent includes corticosteroids.

18. The method according to claim 16 or claim 17, wherein, The active agent includes antibiotics.

19. The method according to any one of claims 16-18, wherein, The drug layer on the fillable member comprises the active agent and one or more adjuvants.

20. A device for treating a narrowed area of ​​a patient's ear or nasal cavity, the device comprising: Slender tube; At least one shock wave emitter, the at least one shock wave emitter being configured to generate at least one shock wave along the working direction; At least one imaging sensor, said at least one imaging sensor being oriented to capture images along the working direction; and A fillable component, which is sealed to the distal end of the elongated tube and surrounds the at least one shock wave emitter and the at least one imaging sensor, is capable of being filled with a conductive fluid.

21. The apparatus according to claim 20, wherein, The fillable member includes a drug coating, and the at least one shock wave delivers a therapeutically effective amount of the drug active agent into the lumen.

Images