Steerable catheter devices with video functionality and methods of treatment using same

Abstract

A steerable sheath and catheter system includes a steerable sheath assembly with camera or visual functionality and a treatment catheter. The sheath assembly is optimized to be compatible with the treatment catheter and provides one or more working channels and visualization functionality during surgery. The sheath assembly may also provide a manipulation function that allows the treatment catheter to enter a lumen (e.g., an airway) of a subject and to be precisely positioned within the lumen for treatment thereof.

Description

[0001] Related Applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 351,173, filed on June 10, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to devices having an elongated body that can enter the airway or lumen of a subject, allowing the user to guide via a vision system, thereby allowing the user to deliver the instrument and device to the treatment site. Background Art

[0004] Doctors perform routine surgical procedures using tools such as bronchoscopes or endoscopes to visualize lumens or cavities and to allow additional tools such as catheters or instruments to pass through the working channel of the scope to perform diagnostic or therapeutic procedures. Today's bronchoscopes have many features such as multi-directional steering, rotating working channels, high definition (HD) quality visual systems, and other features.

[0005] Bronchoscopes typically have working channels with diameters of 2.8 mm to 3.2 mm. However, as medical device technology evolves, larger working channels are needed without sacrificing features such as maneuverability, camera functionality, and illumination. Working channel diameter and maintaining compatibility with different bronchoscope manufacturers may limit technology development.

[0006] Many of these features are not necessary for certain surgical procedures, so a working sheath camera sheath / steerable catheter with video capabilities may meet the needs of a specific surgical procedure. The maintenance cost and robustness of a typical bronchoscope also present challenges that may be eliminated with a lower cost disposable working sheath.

[0007] There remains a need for more versatile scope systems that are configured for use with therapeutic catheters without sacrificing features of traditional scope systems such as visualization, flexibility, and maneuverability. Summary of the invention

[0008] In the examples described below, a steerable sheath and catheter system includes an operative sheath assembly and a treatment catheter, the sheath assembly having a camera or visual function. The sheath assembly is optimized to be compatible with the treatment catheter and provides one or more working channels and visualization functions during a surgical procedure. The sheath assembly may also provide a guide function that allows the treatment catheter to enter a lumen (e.g., an airway) of a subject and be precisely positioned in the lumen.

[0009] In an example, the sheath assembly may include a flexible sheath having a large working channel diameter of about 3.0 mm to about 7.0 mm, and more specifically about 3.9 mm to about 6 mm. The flexible sheath has at least one working channel extending along the length of the sheath. The flexible sheath may include a visualization component on one end of the sheath, which may include at least one camera or imaging source, and one or more light sources, such as LED lights.

[0010] In an example, the sheath may further include grooves along its length that allow ventilation around the sheath during a surgical procedure (e.g., an intubation procedure when the airway is blocked by the sheath). In an example, the sheath may optionally be used for suctioning of the airway when the working channel does not accommodate a treatment catheter.

[0011] In an example, a treatment catheter may include a flexible shaft and an expandable or inflatable member coupled to a distal end of the shaft, and one or more energy emitting elements coupled to the inflatable member. In an example, a camera of the sheath may be positioned on the end of the sheath so that it precisely matches the length of the catheter to allow optical coupling with the expandable member when expanded without further manipulation of the sheath and catheter.

[0012] In another example, the sheath and catheter can be a single steerable catheter device. The working end or energy emitting end of the catheter (optionally expandable) can be incorporated into the flexible sheath itself, rather than being coupled to the flexible sheath. The working end can be telescoped into one end of the sheath and extended from one end of the sheath. In an example, the working end can be manipulated while extended. This configuration can optionally incorporate a suction function through another port or channel defined in the sheath.

[0013] In an example, such a configuration may include multiple cameras for visualization from proximal and distal perspectives of the working end of the catheter. Increasing the distal perspective facilitates placement of electrodes or energy transmitters in the airway. The handle of the manipulable catheter device may allow manipulation of the catheter, expansion and contraction of the working end of the catheter, and rotation of the working end of the catheter. The handle may further include a locking mechanism that locks within a deflection angle of the catheter tip to stabilize the working end of the catheter in the center of the lumen or airway. This may increase the ease of spatial manipulation of electrodes or energy transmitters during surgery.

[0014] In an example, the sheath can be specifically designed to help access difficult to access or tortuous anatomical structures, such as the many branches of the airway, which are currently limited by commercially available bronchoscopes. In one example, the tortuous anatomical structure is the right upper lobe bronchus. Here, the airway is separated from the right main bronchus at an angle close to 90 degrees, and thus the ability to treat in the right upper lobe bronchus is limited. A sheath or flexible catheter system according to an example can be developed that specifically addresses this limitation and allows access to the right upper lobe bronchus.

[0015] The above summary of various representative examples is not intended to describe every illustrated embodiment or every implementation of the present disclosure. Instead, the embodiments are selected and described so that those skilled in the art can understand and appreciate the principles and practices of the present invention. The accompanying drawings in the following detailed description illustrate these embodiments in more detail. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The present disclosure may be more fully understood by considering the following detailed description of various embodiments of the present disclosure in conjunction with the accompanying drawings, in which: Figure 1 is an isometric view of a camera housing assembly according to an example of the present disclosure; Figure 2 yes Figure 1 An isometric view of the far end of the camera housing assembly.

[0017] Figure 3 is an isometric view showing the bending capability of the distal shaft of the camera sheath assembly when activated by a bending lever on the handle of the camera sheath assembly according to an example of the present disclosure.

[0018] Figure 4 is displayed expanded and attached to Figure 1 Isometric view of the balloon catheter assembly with the camera sheath assembly. DETAILED DESCRIPTION

[0019] refer to Figures 1 to 3 , the camera sheath assembly 100 includes an elongated working shaft 110; a handle 120, which is connected to the proximal end of the shaft 110; a bending rod 130, which is used to bend the flexible distal end of the shaft 110 from the shaft 110 at a certain range of angles; a port 140, which is used to connect a treatment catheter thereto; a camera and light connection port 150, which is used to connect an imaging or visualization source and a display thereto; and a distal assembly 200, which includes one or more cameras, channels and / or light sources.

[0020] In the example, the working shaft 110 is a co-extruded tube having a structure defining a plurality of lumens extending along its length from a proximal end to a distal end, which will be referred to as Figure 2In one example, the co-extruded tube has a harder proximal portion 112 and a softer flexible distal portion 114, such that the softer flexible portion can be bent at a certain angle relative to the harder proximal portion 112 ( See, e.g. Figure 3 ). The stiffer proximal portion 112 imparts the shaft with pushing capabilities, while the softer distal portion 114 is bendable to help steer the direction of a catheter (not shown). In an example, the working shaft 110 may include braided Nitinol® or stainless steel wire to aid in structure and performance, such as torque and pushing forces. The braid angle in the stiffer proximal portion 112 may be tighter or higher than that of the distal portion 114 to provide rigidity thereto.

[0021] The handle 120 provides a means for the user to grasp the shaft 110, while providing a housing for the pull wire, cam actuator, wires, and other components of the assembly 100. The bending rod 130 is connected to a cam mechanism (not shown) that, when the rod 130 is actuated, pushes or pulls the wire to bend the distal portion 114 of the shaft 110 relative to the proximal portion 112. The bending rod 130 depicted can be a thumb or finger-activated lever. Alternatively, it can be designed as a trigger-type lever that is activated by pulling a finger.

[0022] Port 140 allows access to the working channel of shaft 110 and allows the handle of a treatment catheter to be connected directly thereto, similar to the connection of the handle of a treatment catheter to the port of a bronchoscope. Suitable treatment catheter and handle assemblies are described, for example, in U.S. Patent Application Publication No. 2016 / 0310210, entitled “Catheter and Handle Assembly, Systems, and Methods,” which is incorporated herein by reference in its entirety. Figure 4 As shown, the handle assembly 310 is removably connected to the port 140 of the handle 120 so that the elongated catheter shaft (not shown) of the treatment catheter assembly 300 is introduced and extended into and through the working channel of the shaft 110 so that the treatment device, depicted as a balloon catheter, extends from the distal end of the shaft 110.

[0023] The handle assembly 310 can be coupled to the handle 120 in any of a variety of ways, such as a snap lock or friction fit, threaded engagement of the handle 120 and the assembly 310, or other mechanisms, such as described in U.S. Patent Application Publication No. 2016 / 0310210. In an example, the treatment catheter assembly 300 is coupled to the handle assembly 310. In one example, the catheter assembly 300 can include a targeted lung denervation RF, microwave or ultrasound catheter and generally includes an elongated shaft 302 and an ablation assembly 304 coupled to a distal portion of the shaft 302, the ablation assembly 304 including an expandable member, such as a balloon or basket, and one or more electrodes or energy transmitters 306 coupled to the expandable member 304. The catheter assembly 300 also includes a cooling circuit, which includes coolant inlet and outlet lumens within the elongated shaft, and a coolant input path and a return path (e.g., a cooling catheter) to circulate coolant to the expandable member 304 and the energy emitter 306; one or more power wires for providing electricity to the energy emitter 306; optional thermocouples and associated wires for measuring and sensing the temperature at the proximal location of the electrode; an optional cooling circuit pressure sensor and associated wires for measuring and sensing the pressure within the cooling circuit; and / or an optional pressure relief valve.

[0024] In an example, a handle assembly 310 is coupled to the proximal portion of the shaft 302. The handle assembly 310 may include a housing 308 fixedly coupled to the proximal end of the shaft 302, and a spindle tube or handle frame (not shown) coupled to the housing so that the spindle tube can be rotatably moved axially relative to the housing and the catheter assembly 300. The handle assembly 310 may further include an umbilical cable with strain relief for coupling the handle assembly 310 and ultimately the catheter assembly 300 to a system console, the system console including a heat exchanger, a coolant pump, an energy generator (e.g., an RF, microwave, or ultrasonic generator), and a system controller. The umbilical cable may facilitate coupling, for example, input and return fluid tubes (coolant) from the system console for coupling the catheter assembly 300 fluid to the heat exchanger and pump of the console, cables / connectors for electrically coupling the electrode 306 of the catheter assembly 300 to an energy source, thermocouple wires for monitoring the temperature of the surface tissue of the treatment site, the electrode, or both, and / or pressure sensors for monitoring the high-pressure coolant input flow and the low-pressure return flow.

[0025] Back to Figure 1 and Figure 2 , camera and light connection 150 allows a visualization system 200 (eg, a camera and light source located at the distal end of shaft 110) to be coupled to a processor board to create a display for showing real-time navigation of the lumen in which the treatment catheter is deployed.

[0026] More specifically, Figure 22 is an isometric view of the distal end of a camera sheath, which may include the following components of a visualization system 200: a distal cap 210, one or more pull wires 220, a camera and light assembly 240, and a working channel 250. In this non-limiting example, the multi-lumen extrusion 200 has four lumens and two air channels 230; however, more or fewer lumens or channels are contemplated. When the sheath 100 is located in the airway, the air channels 230 are used to distribute air to the lungs.

[0027] The distal cap 210 may include a stainless steel cap that allows for the attachment of a pull wire 220. The pull wire 220 is fixedly attached to the end cap 210 via a process such as, but not limited to, laser welding or brazing. The geometry of the end cap 210 is such that it captures a surface of the distal end of the extrusion, allowing the surface to flex when tension is applied to the pull wire 220. Two pull wires are shown in the image; however, the polarity of the pull wires can be used to flex in multiple directions. A camera and light assembly 240 is located within one of the lumens of the extrusion. The camera and light assembly 240 is used to visualize within the cavity, allowing the user to guide the distal end of the sheath 100 to the treatment location. The camera and light assembly 240 can be fixedly attached within the lumen, forming a disposable mechanism. Another option is to use a scope, such as, but not limited to, a fiberscope that can be slid into and removed from the lumen. This option allows the user to reuse the scope and only discard the sheath. The working channel 250 allows instruments and devices (such as the shaft 302 of the catheter assembly 300 and the ablation assembly 403) to enter the treatment site.

[0028] Reference now Figure 3 The shaft 110 includes a flexible portion 112 having a wire (220, ... Figure 2 ) to allow the distal end to bend.

[0029] Systems according to embodiments can be used to manipulate an ablation assembly that includes an expandable member as described above and one or more energy emitters or electrodes, and / or can be designed or configured to axially, rotationally, and / or otherwise manipulate any of a variety of treatment assemblies, including needle-injection and / or needle-free injection or drug delivery systems, such as for injecting or delivering neurotoxins, sclerosants, any of a variety of agents for treating lung disease without the need for an introduction device, such as a bronchoscope. For example, a handle and catheter system can be configured to axially (advance and retract) and / or rotationally guide or manipulate one or more needles or ports in and around an airway while visualizing the system from one or more perspectives. Various non-limiting examples of assemblies are described in one or more of the patents and applications listed below, all of which are incorporated herein by reference in their entirety: U.S. Patent No. 8,088,127, entitled “Systems, Assemblies, and Methods for Treating a Bronchial Tree”; U.S. Patent Application Publication No. 2011 / 0152955, entitled “Delivery Devices with Coolable Energy Emitting Assemblies”; U.S. Patent Application Publication No. 2012 / 0310233, entitled “Systems, Apparatus, and Methods for Treating Tissue and Controlling Stenosis”; U.S. Patent Application Publication No. 2011 / 0118725, entitled “Non-invasive and Minimally Invasive Denervation Methods and Systems for Performing the Same”; U.S. Patent Application Publication No. 2012 / 0302909, entitled “Methods and Systems for Screening Subjects”; U.S. Patent Application Publication No. 2011 / 0301587, entitled “System and Method for Pulmonary Treatment”; U.S. Patent No. 8,172,827, entitled “Apparatus for Treating Asthma Using a Neurotoxin”; U.S. Patent Application Publication No. 2006-0304 entitled “Method and Apparatus for Controlling”; U.S. Patent No. 8,483,831, entitled “System and Method for Bronchial Dilation”; PCT Application No. WO 2013 / 052501, entitled “Apparatuses and Methods for Injuring Nerve Tissue”; U.S. Patent Application Publication No. 2013 / 0310822, entitled “Compact Delivery Pulmonary Treatment System and Method for Improving Pulmonary Function”; U.S. Provisional Patent Application No. 61 / 746,460, entitled “Methods for Improving Drug Efficacy”; U.S. Provisional Patent Application No. 61 / 779,371, entitled “Fluid Delivery System and Method for Treatment”; U.S. Provisional Patent Application No. 61 / 876,925, entitled “Systems, Devices, and Methods for Treating a Pulmonary Disease with Ultrasound Energy”; U.S. Provisional Patent Application No. 61 / 847,477, entitled “Methods for Protecting the Esophagus During Pulmonary Treatment Procedures”; and U.S. Provisional Patent Applications Nos. 61 / 799,742 and 61 / 870,373, entitled “Systems, Devices, and Methods for Treating a Pulmonary Disorder with an Agent.”

[0030] It should also be understood that one or more exemplary embodiments are merely examples and are not intended to limit the scope, applicability or configuration of the subject matter of the present invention in any way. On the contrary, the foregoing detailed description will provide those skilled in the art with an achievable disclosure for implementing the one or more exemplary embodiments. It should be understood that various changes may be made to the function and arrangement of the elements without departing from the scope of the subject matter as set forth in the attached claims and their legal equivalents.

[0031] The above embodiments are intended to be illustrative rather than restrictive. Other embodiments are within the scope of the claims. Although the subject matter of the present application has been described with reference to specific embodiments, those skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of its subject matter.

[0032] After reading this disclosure, various modifications to the subject matter therein will be apparent to those skilled in the art. For example, those of ordinary skill in the relevant art will recognize that, within the spirit of this subject matter, the various features described for the different embodiments of the subject matter may be appropriately combined, uncombined, or recombined with other features, either individually or in different combinations. Likewise, the various features described above should all be considered as example embodiments, rather than limitations on the scope or spirit of their subject matter. Therefore, it is not intended that the foregoing limit the scope of the subject matter of the present invention.

[0033] For purposes of interpreting the claims of the present subject matter, it is expressly intended that the provisions of 35 USC. 112, sixth paragraph not be invoked unless the specific terms "means for" or "step for" are recited in a claim.

Claims

1. A camera housing assembly, comprising: an elongated shaft having a proximal end and a distal end and having structure defining a working channel extending from the proximal end to the distal end; a handle coupled to the proximal end of the shaft, the handle configured to be operably coupled to a treatment catheter; a visualization assembly coupled to the second end of the shaft, the visualization assembly comprising at least one camera and at least one light source; and At least one pull wire is configured to direct the distal end in one or more directions.

2. The camera housing assembly of claim 1, further comprising: A port is configured to be coupled to a handle of the treatment catheter to allow access to a working channel within the shaft, the shaft and ablation assembly of the treatment catheter being configured to extend within the working channel, wherein the port is coupled to the handle.

3. The camera case assembly of claim 1 , wherein the handle of the camera case assembly comprises: A drive rod assists in manipulating at least one puller wire within the working channel of the shaft to bend the distal portion of the shaft relative to the proximal portion of the shaft.

4. The camera holster assembly of claim 3, wherein the drive lever comprises a thumb or finger activated lever, or a trigger activated by pulling with a finger.

5. The camera sheath assembly of claim 3, wherein a distal portion of the shaft has greater flexibility than a proximal portion of the shaft.

6. The camera holster assembly of claim 5, wherein the shaft is formed of a braided sheath, and a braid angle of the distal portion is less than a braid angle of the proximal portion.

7. The camera holster assembly of claim 3, wherein the proximal portion has a length greater than a length of the distal portion.

8. The camera housing assembly of claim 1, wherein the shaft is a co-extruded tube comprising a plurality of lumens.

9. The camera housing assembly of claim 1, wherein the shaft further comprises: a plurality of air channels for distributing air to treatment locations; and A distal cap allows for the assembly and connection of multiple pull wires.

10. The camera sheath assembly of claim 9, wherein the pull wire is connected to the distal cap via laser welding or soldering.

11. The camera sheath assembly of claim 1 , wherein the handle further comprises a camera / light port to signal data received from the visualization assembly to a receiving processor board to generate display imaging data for visualization and navigation to a treatment site.

12. The camera sheath assembly of claim 1, wherein the working channel has a diameter of about 3.9 mm to about 6 mm.

13. The camera sheath assembly of claim 1, wherein the shaft further comprises a groove defined on an outer surface thereof, the groove configured to allow ventilation around the sheath during an intubation procedure.

14. The camera sheath assembly of claim 1, wherein the camera sheath assembly is configured to aspirate a lumen of a subject when the working channel does not house the treatment catheter.

15. The camera sheath assembly of claim 1, wherein the camera sheath and catheter assembly are operable as a single steerable catheter assembly by which the working end of the treatment catheter is incorporated into the shaft of the assembly.

16. The camera sheath assembly of claim 15, wherein the combination of the shaft of the camera sheath assembly and the treatment catheter is configured with a plurality of cameras for visualizing proximal and distal views of the working end of the treatment catheter.

17. A method of accessing a treatment site comprising: coupling a treatment catheter to the camera sheath assembly of claim 1; and The treatment catheter is guided to the treatment site via the handle, wherein the shaft of the treatment catheter is contained within the working channel of the shaft, and wherein the length of the catheter provides optimal coupling for visualization and guidance capabilities during the procedure, by which the catheter is precisely positioned into the airway.

18. The method of claim 17, wherein the working end of the shaft of the treatment catheter comprises an expandable member having at least one energy emitter located thereon, the method further comprising: advancing the expandable member in a collapsed state through the working channel and the distal end of the shaft; and causing the expandable member to expand to an expanded state, The expandable member and its position are visible on a display screen operably connected to the visualization assembly.

19. The method of claim 18, further comprising: Energy is delivered from at least one energy emitter of the expandable member to a first treatment site to treat a condition of the airway.

20. The method of claim 19, further comprising: moving the at least one energy transmitter to a second treatment site while displaying the second treatment site on the display screen; and Energy is delivered from at least one energy emitter of the expandable member to a first treatment site to treat a condition of the airway.

21. The method of claim 19, further comprising: Air is provided to the airway via an airway passage formed in the shaft while energy is delivered to the treatment site.

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