Endoscopic suction method and device

Abstract

An endoscopic instrument is provided. The instrument includes a handle (20), a steering sheath (10) disposed on the handle, and a flexible tube (72). The instrument further includes a light source (78) and an image sensor (76) disposed on the flexible tube. The handle includes a passageway. The steering sheath includes a tip, a steering section, and a lumen. The steering section of the steering sheath is actuatable to form a bend so that the tip can be actuated to be steered to an anatomical region within a patient's body. The flexible tube is configured to be inserted into the lumen and the inner passageway so that the light source and image source are located at or near the tip of the steering sheath. The flexible tube is further configured to be removed from the lumen so that the lumen can be actuated to aspirate internal matter from the anatomical region through the tip.

Description

[Technical Field]

[0001] A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction of the patent document or patent disclosure as contained in the U.S. Patent and Trademark Office patent file or records, but otherwise reserves all copyrights whatsoever.

[0002] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is an International Patent Cooperation Treaty application claiming priority to and benefit of a previously filed, co-pending U.S. Non-Provisional Patent Application No. 18 / 082,435, filed December 15, 2022, entitled "Method and Device for Endoscopic Aspiration," all of which are incorporated herein by reference in their entirety.

[0003] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT Not applicable.

[0004] (Reference to Sequence Listing or Computer Program Listing Appendix) Not applicable.

[0005] The present disclosure relates generally to instruments and methods for endoscopic surgery, and more particularly to providing an endoscopic instrument for performing minimally invasive endoscopic removal of an object from within a patient's body. [Background technology]

[0006] Each year, 3.5 million people suffer from kidney (e.g., nephrogenic) stones (e.g., calculi). Generally, and as used herein, a "stone" or "concretion" is a type of internal body object that is a hard deposit of minerals and salts that forms inside the body. Kidney stones are also a subset of stones (and stones located within the kidney), particularly those that form within the kidney. Of the approximately 700,000 kidney stone-related conditions, one in five requires intervention. Of these 700,000 patients, 63 percent have small kidney stones, which are often adequately treated with current standard treatments, including flexible ureteroscopy.

[0007] Generally speaking, ureteroscopy is a form of endoscopy, a procedure in which an instrument is introduced into the body (through a natural orifice or via a percutaneous approach) to visualize and / or adjust the interior of the body. Such instruments are typically referred to as "endoscopes," or, if specifically configured for ureteroscopic procedures, as "ureteroscopes." Such instruments are often configured to navigate various body cavities, hence the terms "flexible endoscopes" or "flexible ureteroscopes." In some cases, endoscopic or ureteroscopic procedures involve the removal of internal objects, including, but not limited to, stones. Specifically, ureteroscopy is performed in the upper urinary tract to address (e.g., in some cases, remove) kidney stones. Of course, those skilled in the art will recognize that endoscopes are used in many other areas of the body to remove internal objects, such as stones. By way of example, flexible endoscopes may also be used in the gastrointestinal (GI) tract, abdomen, lungs, brain, etc., via natural orifices or other percutaneous approaches.

[0008] To illustrate endoscopic procedures as applied to the specific context of ureteroscopy, a typical ureteroscopy procedure may involve passing a ureteroscope through the urethra, bladder, and directly into the upper urinary tract to remove a kidney stone (or other internal body object). Depending on the size of the kidney stone to be removed, the ureteroscopy procedure may require laser lithotripsy (i.e., using a laser to break up the kidney stone into tiny fragments) via the endoscope before using the ureteroscope to "basket" the fragments (i.e., deploying a flexible (nitinol) ureteroscope kidney stone basket from the endoscope to capture and remove them). In other cases, the ureteroscopy procedure may simply require "dusting" (i.e., using a laser to break up the kidney stone into fragments small enough for natural passage). However, as alluded to above, such methods may be applied to the more general field of endoscopic procedures for removing stones and other internal body objects and are by no means unique to ureteroscopy.

[0009] However, as kidney stones increase in size, conventional procedures become difficult and ineffective. Surgeons face a formidable dilemma regarding how to treat the remaining 37 percent of patients (approximately 260,000 patients annually in the United States alone) with large kidney stones (e.g., 11 mm or larger in diameter). For example, due to limited dexterity in performing laser lithotripsy and aiming the laser to capture kidney stone fragments using a basket, procedures involving large kidney stones are relatively long (e.g., over two hours) and highly variable (e.g., risk of complications related to the prolonged presence of the ureteroscope within the patient). This is particularly true for lower pole cases (e.g., cases involving stones located in the lower calyx of the kidney), which may be the most common type of kidney stone suffered by patients. In these cases, the anatomical location of the kidney stones makes it extremely challenging to effectively capture all stones with the basket due to the aforementioned lack of dexterity. Therefore, in these cases, patients may be advised of more invasive procedures, such as percutaneous nephrolithotomy (PCNL) surgery. Needless to say, such problems are prevalent not only in ureteroscopic procedures, but generally in all endoscopic procedures dealing with large stones or other internal objects.

[0010] To make ureteroscopy, and endoscopic procedures as a whole, more suitable for the aforementioned burden of large stones or other body objects, it may be desirable to perform an "aspiration" (e.g., suction-based) procedure, which may involve using a vacuum source to aspirate the body object en masse. However, the limited working channel size (one and a fifth of a millimeter) of conventional flexible endoscopes may be too small to be effective. Recently, new and improved body-entering sheaths have been developed to act as aspiration catheters with large lumens that allow for the aspiration and removal of stone fragments up to three millimeters in diameter. Aspiration through these improved body-entering sheaths has been proven to reduce operation time and improve stone-free rates. This stone removal approach may combine the benefits of dusting or basketing while substantially improving procedure time, especially for larger stones. In fact, aspiration procedures have been proven to result in higher "stone-free" (i.e., no stones remaining in the target body area) rates than basketing, potentially reducing the patient burden of repeated operating room visits.

[0011] Despite the great promise of aspiration procedures, this system presents several obstacles to widespread adoption of the aforementioned body-entering sheath, which acts as a suction catheter. For example, in the context of ureteroscopy, the size of the body-entering sheath and the need for a large lumen through which suction is delivered preclude physicians from simultaneously using both the ureteroscope and the suction catheter using a transurethral approach. This means that the physician must completely remove the ureteroscope from the patient before placing the suction catheter in place, completely compromising visibility and potentially increasing the number of tool exchanges and causing ureteral trauma. The suction catheter must be blindly placed in the ureter by the physician and advanced to the precise location under continuous fluoroscopic feedback, exposing both the physician and the patient to harmful x-rays. For another example, in the context of ureteroscopy, the suction catheter has limited bidirectional flexibility (135 degrees for the suction sheath compared to 270 degrees for a typical ureteroscope), which is lower than the ureteroscope itself. Therefore, the physician must carefully relocate the kidney stone to a more favorable location within the kidney that is more easily accessed by a less precise aspiration catheter. Needless to say, this problem is not only specific to the ureteroscopic procedure for removing kidney stones, but is widespread throughout the field of endoscopic removal of stones or other internal objects. Summary of the Invention [Problem to be solved by the invention]

[0012] What is needed, therefore, is an improved stone aspiration procedure device and method for ureteroscopic removal of kidney stones within a patient. [Means for solving the problem]

[0013] This Summary is provided to introduce selected concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0014] One aspect of the present disclosure is an instrument for performing endoscopic surgery within a patient's body. The instrument includes a handle, a steering sheath, a flexible tube, a light source, and an image sensor. The handle includes a passageway. The steering sheath is disposed on the handle. The steering sheath includes a tip, a steering section, and a lumen. The steering section of the steering sheath is actuatable to form a bend so that the tip can be actuated to be steered to an anatomical region within the patient's body. The light source and the image sensor are disposed on the flexible tube. The flexible tube is configured to be inserted into the lumen and the inner passageway so that the light source and image source are located at or near the tip of the steering sheath. The flexible tube is further configured to be removed from the lumen so that the lumen is actuatable to aspirate bodily matter from the anatomical region through the tip.

[0015] Another embodiment of the present disclosure is a method for performing endoscopic surgery within a patient's body. The method includes providing a steerable sheath, a flexible tube, a light source, and an image sensor. The steerable sheath includes a steerable section and a lumen. The flexible tube includes a distal end. The light source and the image sensor are disposed on the distal end of the flexible tube. The method further includes advancing the flexible tube within the lumen of the steerable sheath. The method further includes forming a bend in the steerable section of the steerable sheath. Forming a bend in the steerable section of the steerable sheath steers the distal end to an anatomical region within the patient's body. The method further includes retracting the flexible tube within the lumen to open the lumen. The method further includes aspirating the body material from the lumen.

[0016] Another aspect of the present disclosure is an instrument for performing endoscopic surgery. The instrument includes a steering sheath, a flexible tube, a light source, and an image sensor. The flexible tube includes a distal end. The steering sheath includes a distal end, a lumen, and a steering section that is actuatable to form a bend so that the distal end can be steered to an anatomical region within a patient's body. The steering section includes a concentric tube structure having nested concentric tubes. Actuation of the steering section is performed through application of axial pushing and pulling forces to the concentric tube. The light source and the image sensor are disposed at the distal end of the flexible tube. The flexible tube is disposed within the lumen such that the distal end is located at or near the distal end.

[0017] Numerous other objects, advantages and features of the present disclosure will become readily apparent to those skilled in the art upon review of the following drawings and description of the preferred embodiments. [Brief explanation of the drawings]

[0018] [Figure 1] 1 is a perspective view of an endoscopic stone removal instrument according to some embodiments, including a handle, a steering sheath coupled to the handle, and an insert assembly inserted into the steering sheath and the handle. [Figure 2] FIG. 2 is a detailed perspective view of the distal end of the steering sheath of FIG. 1, according to some embodiments. [Figure 3] 2 is a perspective view of the insert assembly of FIG. 1 being inserted into the steering sheath and handle of FIG. 1 according to some embodiments. [Figure 4] FIG. 2 is a perspective view of the insert assembly of FIG. 1 according to some embodiments. [Figure 5] FIG. 5 is a detailed perspective view of a flexible tube of the insert assembly of FIG. 4 according to some embodiments. [Figure 6] FIG. 2 is a perspective view of the steering sheath and handle of FIG. 1 according to some embodiments. [Figure 7] FIG. 7 is a detailed perspective view of the distal end 16 of the steering sheath of FIG. 6, according to some embodiments. [Figure 8]FIG. 2 is a side view of the steering sheath of FIG. 1 according to some embodiments. [Figure 9] 9 is a side view of the outer sheath tube and inner sheath tube of the steering sheath of FIG. 8, according to some embodiments. [Figure 10A] 9 is a side view of the steering sheath of FIG. 8 being actuated to form a bend, according to some embodiments. [Figure 10B] 9 is a perspective view of the steering sheath of FIG. 8 being actuated to form a bend, according to some embodiments. [Figure 11A] 9 is a side view of the steering sheath of FIG. 8 being actuated to form a bend, according to some embodiments. [Figure 11B] 9 is a perspective view of the steering sheath of FIG. 8 being actuated to form a bend, according to some embodiments. [Figure 12A] FIG. 10 is a detailed side view of the outer sheath tube of FIG. 9, according to some embodiments. [Figure 12B] 10 is a detailed side view of the inner sheath tube of FIG. 9, according to some embodiments. [Figure 13] 2 is an alternative embodiment of the steerable sheath tube of FIG. 1. [Figure 14A] FIG. 14 is a side view of the steerable sheath tube of FIG. 13 being actuated to form a bend, according to some embodiments. [Figure 14B] FIG. 14 is a perspective view of the steerable sheath tube of FIG. 13 being actuated to form a bend, according to some embodiments. [Figure 15] FIG. 14 is a detailed perspective view of the distal end 16 of the steering sheath of FIG. 13, according to some embodiments. [Figure 16A] 2 is a perspective view of the instrument of FIG. 1 actuated to drive the steering sheath of FIG. 1 according to some embodiments. [Figure 16B] 2 is a perspective view of the instrument of FIG. 1 actuated to drive the steering sheath of FIG. 1 according to some embodiments. [Figure 17] 2 is a schematic diagram of the device of FIG. 1 shown engaged with a kidney stone in a patient's anatomy, according to some embodiments. [Figure 18] 18 is a detailed schematic diagram of the steerable sheath and insert assembly of the device of FIG. 17 shown engaged with a kidney stone within a patient's anatomy, according to some embodiments. [Figure 19] 7 is a schematic diagram of the handle of FIG. 6 and the steerable sheath of FIG. 6 shown aspirating a kidney stone from within a patient's anatomy, according to some embodiments. [Figure 20] 20 is a detailed schematic diagram of the steerable sheath of FIG. 19 shown aspirating a kidney stone from within a patient's anatomy, according to some embodiments. [Figure 21] 1 is a perspective view of an instrument for endoscopic stone removal including a handle, a steering sheath coupled to the handle, and an insert assembly attached to the steering sheath, according to some alternative embodiments. [Figure 22] FIG. 22 is a detailed perspective view of the distal end of the steering sheath of FIG. 21, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0019] While the making and use of various embodiments of the present invention are discussed in detail below, it should be recognized that the present invention provides many applicable inventive concepts embodied in a variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the invention and do not delimit the scope of the invention. Those skilled in the art will recognize numerous equivalents to the specific devices and methods described herein. Such equivalents are considered to be within the scope of this invention and are covered by the claims.

[0020] In the drawings, for the sake of clarity, not all reference numbers are necessarily included in each drawing. Additionally, positional terms such as "upper," "lower," "side," "top," "bottom," etc. refer to the device when in the orientation shown in the drawings. Those skilled in the art will recognize that the device may be in different orientations when in use.

[0021] The present disclosure provides instruments and methods for endoscopic surgery within a patient's body. Specifically, the present disclosure relates to the retrieval and / or removal of body material by suction during an endoscopic (or, more particularly, ureteroscopic) procedure. For example, body material that may be removed via the instruments and methods described herein may include, but is not limited to, stones, such as kidney stones or other calculi.

[0022] Specifically, the present disclosure provides an endoscope (or, more particularly, a ureteroscope) with a removable insert assembly that can be inserted into a steering sheath to provide a central core within the steering sheath configured to deliver an image sensor, a light source, and / or one or more ports. One or more ports can be used for delivery of endoscopic tools (such as a laser lithotriptor), irrigation (e.g., fluid delivery), and / or suction for aspirating fluids and / or other bodily material. In other words, the present disclosure provides an endoscopic instrument that initially functions like a conventional endoscope. However, when the insert assembly is removed from the steering sheath, an open lumen within the steering sheath is revealed that is configured for aspirating stones or other bodily material.

[0023] In some embodiments, the open lumen is larger than any of the one or more ports and is therefore better configured for aspiration of large stones, stone fragments, or other body objects. Thus, for example, after a stone is broken into fragments using a laser lithotriptor facilitated by the insert assembly, the insert assembly can be removed, leaving the steerable sheath (and the now-emerging open lumen) directly in the anatomical region (e.g., the surgical site) for aspirating the fragments, thereby eliminating the need for blindly inserting a separate aspiration catheter to aspirate the fragments and protecting both the patient and physician from harmful fluorescent radiation required for placement confirmation. Additionally, in addition to or as an alternative to aspirating stones or other body objects, the open lumen can serve as a conduit for delivery of additional tools (e.g., thermal ablation probes, baskets, lithotripsy tools, ultrasound imaging probes, surgical grasping tools, etc.) and / or for irrigation of the anatomical region.

[0024] While the present disclosure is largely illustrated herein as being applied to a ureteroscopic procedure for the removal of kidney stones (and stones located therein) from within the kidney, it should be appreciated that the instruments and methods described herein may be applied to a variety of endoscopic procedures for the removal of stones or other internal objects in a variety of anatomical settings, structures, and circumstances. For example, as alluded to above, endoscopes are used to remove various types of internal objects in many other areas of the body (e.g., the GI tract, the abdomen via natural orifices or other percutaneous approaches, the lungs, the brain, etc.). Thus, it should be apparent to those skilled in the art that, in addition to applications related to ureteroscopy and kidney stone removal, the present disclosure may be equally useful for endoscopy and the removal of stones or other internal objects in general. For example, it may be advantageous to provide an instrument that initially functions like a modern endoscope (e.g., delivering the image sensor, light source, and / or one or more ports described above) and then, by removing the insert assembly described above, transforms the endoscopic instrument into a steerable sheath with an appropriately sized lumen for the delivery of additional tools and / or irrigation of the anatomical region, as well as for the aspiration of large stones, stone fragments, or other internal objects.

[0025] Overall, by combining traditional endoscopic or ureteroscopic procedures with laser lithotripsy and stone aspiration, the present disclosure may offer advantageous solutions to the above-mentioned dilemmas associated with treating patients with large stones or other internal objects. By way of non-limiting example, by resolving the above-mentioned problems prevalent in ureteroscopic procedures, the present disclosure may make ureteroscopy a clear treatment option in place of invasive procedures in cases of large kidney stones.

[0026] 1-3, an introductory embodiment of an instrument 100 for retrieving material from a patient's body is generally illustrated. As described herein, the instrument 100 may provide a minimally invasive medical device for removing material from a patient's body. As a non-limiting example, in a ureteroscopy setting, the instrument 100 may be configured to remove kidney stones from a patient's kidney or urinary system. The instrument 100 may include a steerable sheath 10, an insert assembly 70, and a handle 20. The steerable sheath 10 may include a steerable section 12 and a transmission section 14. Additionally, the steerable sheath 10 may define an inner lumen 18 extending along the length of the steerable sheath 10. As described in more detail below with respect to FIGS. 8-15, the steerable sheath 10 may be actuable to form a bend when manipulated by the handle 20, thereby bending a tip 16 located at the distal end of the steerable sheath 10 in a curved path. 7, the lumen 18 can define an outer diameter D1 that includes a first inner diameter D2 that is large enough to aspirate bodily material from the anatomical region, deliver one or more first endoscopic tools to the anatomical region, and / or irrigate the anatomical region (e.g., provide an irrigant flow). In some embodiments, the steerable sheath 10 is disposed on a handle 20. For example, the steerable sheath 10 can be mechanically coupled to the handle 20. As another example, the steerable sheath 10 and the handle 20 can be formed as a single component.

[0027] In some embodiments, the insert assembly 70 includes a flexible tube 72 having an end 74. The flexible tube 72 can be configured to deliver various endoscopic components. For example, an image sensor 76 and a light source 78 can be disposed in the flexible tube 72. In some embodiments, the image sensor 76 and the light source 78 are disposed in the flexible tube 72. For example, the image sensor 76 and the light source 78 can be disposed at an end 74 of the flexible tube 72. In some embodiments, the flexible tube 72 includes a working conduit 73 and / or a irrigation conduit 79. The above-mentioned endoscopic components, particularly the image sensor 76 and / or the light source 78, can be controlled via the insert assembly control module 71 in operative communication with the flexible tube 72.

[0028] In some embodiments, insert assembly 70 may include a tool and / or irrigation port 77. As one example, tool and / or irrigation port 77 may be in communication with irrigation flow conduit 79 of flexible tubing 72 and configured to irrigate the anatomical region through irrigation conduit 79 at end 74. As another example, tool and / or irrigation port 77 may be in communication with working conduit 73 and configured to accommodate one or more second endoscopic tools (e.g., appropriately sized instruments for laser lithotripsy procedures) that may be passed through working conduit 73 to end 74 for use in the anatomical region.

[0029] As shown particularly with respect to FIG. 3 , the insert assembly 70 may be inserted into the handle 20 at the proximal opening 28 thereof so that the insert assembly 70 is positioned within the interior passageway of the handle 20 and the lumen 18 of the steering sheath 10 to accommodate various endoscopic instruments at or near the distal end 16. A flexible tube 72 may be advanced along the lumen 18 of the steering sheath until the insert assembly 70 fully fits within the handle 20 and the steering sheath 10. As one example, the control module 71 may have a shape that fits within the proximal opening 28 of the handle 20 when the insert assembly 70 fully fits within the handle 20 and the steering sheath 10. As another example, an end 74 of the flexible tube 72 may be positioned proximal to the distal end 16 of the steering sheath 10 when the insert assembly 70 fully fits within the handle 20 and the steering sheath 10. Thus, in the configuration shown with respect to Figures 1 and 2, the device 100 may provide a flexible endoscope, or more particularly a flexible ureteroscope.

[0030] As shown particularly with respect to FIG. 3 , the insert assembly 70 can also be removed from the handle 20 and steerable sheath 10 (e.g., by disengaging the insert assembly control module 71 away from the proximal opening 28). For example, the flexible tube 72 can be retracted along the lumen 18 so that the lumen 18 is open, resulting in the configuration depicted with respect to FIGS. 6 and 7 for the steerable sheath 10 and handle 20. As noted above, the lumen 18 can be large enough for aspirating bodily material from an anatomical region. Thus, in some embodiments related to ureteroscopic procedures, the steerable sheath 10 and handle 20 as shown with respect to FIG. 3 are operable to perform kidney stone aspiration. In other embodiments, the steerable sheath 10 and handle 20 shown are operable to perform aspiration of other stones or bodily material.

[0031] 4 and 5, an insert assembly 70 is shown according to some embodiments. As mentioned above, the insert assembly 70 may include a flexible tube 72 that facilitates movement of the image sensor 76, the light source 78, the working conduit 73, and / or the irrigation conduit 79 as controlled by the insert assembly control module 71. The flexible tube 72 is passively flexible and may house various wires and connections for operatively coupling the image sensor 76 and the light source 78 to the insert assembly control module 71. As alluded to above, the flexible tube 72 may house the working conduit 73 and the irrigation conduit 79, each of which terminates at an end 74 of the flexible tube 72. The working conduit 73 may define a second inner diameter D3, and the irrigation conduit 79 may define a third inner diameter D4. Each of the second inner diameter D3 and the third inner diameter D4 may be smaller than the first inner diameter D1 of the lumen 18. Although depicted herein as a single conduit, the working conduit 73 and / or the cleaning conduit 79 may include multiple conduits depending on the implementation.

[0032] In some embodiments, the image sensor 76, light source 78, irrigation line 79, and / or working line 73 are disposed at end 74 via end cap 80. End cap 80 may be constructed in any suitable manner to accommodate the instruments and methods described herein. As one example, end cap 80 may be constructed from an injection-molded, biocompatible, hard plastic. As another example, end cap 80 may be 3D printed. As yet another example, end cap 80 may be machined via CNC or wire EDM techniques (using any number of biocompatible metal alloys that can be machined to the desired configuration). In some embodiments, end cap 80 includes keyway features that mate with corresponding key features on steerable sheath 10 to prevent rotation of flexible tube 72 and / or steerable sheath 10 relative to one another.

[0033] In some embodiments, the image sensor 76 includes a digital complementary metal-oxide semiconductor (CMOS) sensor for providing digital visualization of the anatomical region. Thus, via the CMOS sensor, the image sensor 76 can provide the resolution, frame rate, and field of view required to provide high-quality imaging of the anatomical region. Additionally, the image sensor 76 can include an optical path (e.g., lenses, filters) to precondition the incident light optimally for image detection by the CMOS sensor. The image sensor 76 can be housed in a separate housing (either alone or, for example, within the end cap 80) designed to mechanically secure to the flexible tubing 72, light source 78, and / or working conduit 73. Signals to and from the image sensor 76 can be transmitted to the insert assembly control module 71 via wiring extending along the length of the flexible tubing 72. In an alternative embodiment, the image sensor 76 is located away from the end 74. For example, image sensor 76 may include a fiber optic cable that extends through flexible tubing 72 to distal tip 54 and relays images back to image sensor 76. Accordingly, image sensor 76 may be located in various locations on instrument 100, such as in insert assembly control module 71 or some other suitable location.

[0034] In some embodiments, light source 78 is a bundle of fiber optics for transmitting light from insert assembly control module 71 to end 74 to provide illumination to the anatomical region. For example, light source 78 may include a fiber optic cable extending through flexible tubing 72 to distal tip 54. Such a fiber optic cable may be configured to transmit light from a lamp (e.g., an LED or incandescent lamp) that may be disposed in insert assembly control module 71 or an external video processor unit. Such a fiber optic cable may be constructed to prevent breakage and light leakage at the smallest radii of curvature expected to be encountered during normal use of flexible tubing 72.

[0035] As alluded to above, the image sensor 76 and / or the light source 78 may be controlled via the insert assembly control module 71. For example, the insert assembly control module 71 may include various programmable buttons (e.g., button 81) or other interfaces operable to provide trigger signals to the image sensor 76 and / or the light source 78. By way of example, button 81 may be pressed by a user to activate or deactivate the light source 78, to implement an image capture function in the image sensor 76, to implement a video recording feature in the image sensor 76, etc. In some embodiments, the insert assembly control module 71 is powered by an external source. For example, the insert assembly control module 71 may be connected to an external power source via power line 75. In other embodiments, the insert assembly control module 71 is powered by an on-board battery. In still other embodiments, the insert assembly control module 71 is in electrical communication with the handle 20 when the insert assembly control module 71 is fitted into the proximal opening 28 and may draw stored power from the power source.

[0036] As alluded to above, flexible tubing 72 may be configured to connect end cap 80 to insert assembly control module 71 while providing an internal passageway that allows for the passage of necessary wires and / or fiber optic cables to facilitate the function of image sensor 76, light source 78, and / or working conduit 73. In a preferred embodiment, flexible tubing 72 is long enough so that a small portion of it is disposed within, flush with, or at least a small portion of it protrudes from distal end 16 of steering sheath 10 when insert assembly 70 is assembled to handle 20.

[0037] In some embodiments, the flexible tube 72 is constructed from a highly elastic polymeric material or a metal alloy such as Nitinol. In such embodiments, the flexible tube 72 may feature a pattern of laser-cut or micro-machined slots (e.g., notches) employed to reduce bending compliance and modify the torsional and axial properties of the flexible tube 72. In other embodiments, the flexible tube 72 is a composite tube constructed from one or more layers (e.g., a polymer liner layer, a polymer jacket layer, a braided reinforcement layer, some combination thereof, etc.). In a preferred embodiment, the flexible tube 72 is configured to provide the necessary bending compliance to allow sufficient flexure of the steering tip 10 over its intended range of motion, while also providing sufficient axial stiffness to prevent kinking when the insert assembly 70 is inserted into the handle 20.

[0038] In some embodiments, the mechanical properties of the flexible tube 72 are constant along the entire length of the flexible tube 72. In other embodiments, the mechanical properties of the flexible tube 72 vary along the length of the flexible tube 72. For example, depending on the clinical application of the instrument 100, it may be advantageous to configure the distal portion of the flexible tube 72 (e.g., toward the end 74) to have a lower bending stiffness than the proximal portion of the flexible tube 72 (e.g., toward the insert assembly control module 71). As described above, the flexible tube 72 may feature a pattern of laser-cut slots. In such a configuration, variations in the mechanical properties along the length of the flexible tube 72 may be achieved by adjusting the spacing (e.g., pitch, cut percentage, etc.) of the slots along the length of the flexible tube 72. As further described above, the flexible tube 72 may be constructed from a composite tube constructed from one or more layers. In such a configuration, variations in the mechanical properties along the length of the flexible tube 72 may be achieved by modifying the jacket material or braided reinforcement configuration along the length of the flexible tube 72.

[0039] 6 and 7 , a handle 20 and steering sheath 10 are shown according to some embodiments. The handle 20 may include a body 21, a steering sheath control module 24 disposed in the body 21, a steering sheath control member 26, a proximal opening 28 defined by the body 21, an aspiration port 29 disposed in the body 21, and a hub 22 disposed in the body 21 and connecting the body 21 to the transmission section 14 of the steering sheath 10. As mentioned above, the configuration shown may be achieved by removing the insert assembly 70 from the steering sheath 10 and handle 20 (e.g., by disengaging the insert assembly control module 71 away from the proximal opening 28) and opening the lumen 18 so that the steering sheath 10 and handle 20 may be operable to perform an aspiration procedure. As a corollary, in some embodiments, the proximal opening 28 is configured to allow insertion of the insertion assembly 70 into the handle 20 and steering sheath 10, thereby assembling the instrument 100 shown above with respect to FIG.

[0040] In some embodiments, the lumen 18 is configured to define a first inner diameter D2 such that, when the insert assembly 70 is removed as described herein, the lumen 18 is suitable for aspirating stones (kidney stones in the context of ureteroscopy), stone fragments, and other bodily material. The lumen 18 may also be configured to irrigate an anatomical region or deliver one or more first endoscopic tools described above to the anatomical region. By way of example, the lumen 18 may be configured to provide a greater volume of irrigation than the third inner diameter D4 of the irrigation line 79 would allow. As another example, the one or more first endoscopic tools may be larger than the one or more second endoscopic tools described above that are suitable for delivery via the working line 73. In this regard, the one or more first endoscopic tools may include a laser for laser lithotripsy, a thermal ablation probe, a basket, a biopsy tool, an ultrasound imaging probe, a surgical grasping tool, or the like, any of which may not be suitable for delivery to the anatomical region via the working line 73. In this sense, it goes without saying that the first inner diameter D2 can be larger than the second inner diameter D3 and the third inner diameter D4.

[0041] In some embodiments, the handle 20 includes various features that allow a user to control the steering sheath 10. For example, steering sheath control members (e.g., lasers, switches, knobs, buttons, etc.) 26 can be disposed on the steering sheath control module 24 and can be manipulated by a user (as shown with respect to FIGS. 16A and 16B ) to drive bending of the steering section 12 of the steering sheath 10 (as described in more detail below with reference to FIGS. 8-15 ). Specifically, the steering sheath control members 26 can be in operative communication with a mechanical transmission disposed on or within the body 21. The mechanical transmission can be configured to translate manipulation of the steering sheath control members 26 into various mechanical engagements with the steering sheath 10 to drive bending of the steering section 12.

[0042] In some embodiments, the operation of the mechanical transmission and steering sheath control member 26 is supported by a power source. For example, manipulation of the steering sheath control member 26 can be converted by a controller in the steering sheath control module 24 into an electrical signal sent to the mechanical transmission, which then converts the electrical signal into the appropriate mechanical engagement with the steering sheath 10. In other words, the mechanical transmission can operate as an electric motor. Therefore, a power source can be used to drive the electrical signals of the steering sheath control module 24 and the function of the mechanical transmission when operating as an electric motor. Accordingly, the steering sheath control module 24 (or the handle 20 more generally) can include a power source. In some embodiments, the power source is external (e.g., hard-wired). In other embodiments, an on-board battery is housed elsewhere in the steering sheath control module 24 or the handle 20 to provide the power source.

[0043] As described above, the steerable sheath 10 includes a transmission section 14 that couples the steerable section 12 to the handle 20 at the hub 22. The transmission section 14 may incorporate the necessary bending compliance, torsional stiffness, and axial stiffness required for navigation through the patient anatomy expected during a clinical procedure. For example, as shown with respect to Figures 17-20, this may include travel through the bladder, up the ureter, and to the kidney.

[0044] Any number of manufacturing techniques common to the fabrication of flexible medical devices can be used to manufacture the flexible transmission section 14, so long as the flexible transmission section 14 exhibits the requisite mechanical properties (e.g., bending compliance, axial stiffness, torsional stiffness, minimum radius of curvature). In some embodiments, as discussed below, the transmission section 14 is an extension of the same material used to construct the steerable section 12. In other embodiments, the transmission section 14 can be constructed of a separate material that is attached to the material of the steerable section 12 via any number of fastening methods, including, but not limited to, reflow, laser welding, adhesives, or mechanical fastening methods such as crimping, keying, or swaging. In some embodiments, the transmission section 14 is constructed from a highly modulus polymer material or a metal alloy such as Nitinol. In such embodiments, the transmission section 14 can feature a pattern of laser-cut or micro-machined slots employed to reduce bending compliance and modify the torsional and axial properties of the transmission section 14. In other embodiments, power transmission section 14 is a composite tube constructed of one or more layers (eg, a polymer liner layer, a polymer jacket layer, a braided reinforcement layer, some combination thereof, etc.).

[0045] In some embodiments, the mechanical properties of the transmission section 14 may be constant throughout the entire length of the transmission section 14. In other embodiments, the mechanical properties of the transmission section 14 vary along its length. For example, depending on the clinical application of the instrument 100, it may be advantageous to configure the distal portion of the transmission section 14 (e.g., toward the sheath tip 16) to have a lower bending stiffness than the proximal portion of the transmission section 14 (e.g., toward the handle 20). As described above, the transmission section 14 may feature a pattern of laser-cut slots. In such a configuration, the variation in mechanical properties along the length of the transmission section 14 may be achieved by adjusting the spacing (e.g., pitch, cut percentage, etc.) of the slots along the length of the transmission section 14. As further described above, the transmission section 14 may be constructed from a composite tube constructed of one or more layers. In such a configuration, the variation in mechanical properties along the length of the transmission section 14 may be achieved by modifying the jacket material or braided reinforcement configuration along the length of the transmission section 14.

[0046] Referring now to FIG. 8 , a steerable sheath 10 is shown according to some embodiments. As described above, the steerable sheath 10 includes a steerable section 12 and a transmission section 14. Specifically, the steerable section 12 may be configured to flex the tip 16 along a curved path by creating an amount of angulation (e.g., bidirectional bending) relative to a geometric (e.g., central) axis 19 defined by the steerable sheath 10 (when positioned in a straight or linear configuration). For example, with reference to FIGS. 10A-11B , the tip 16 may flex along a first curved path 46 or a second curved path 48, as described in more detail below. This may allow the tip 16 to be steered toward an anatomical region within a patient's body (e.g., toward an anatomical region, toward an internal object, toward a stone or kidney stone, etc.). Depending on the implementation, the steerable section 12 may exhibit a constant curvature when the tip 16 is flexed, or the steerable section 12 may exhibit a variable curvature.

[0047] As alluded to above, depending on the implementation, various characteristics of the steerable sheath 10 can be configured according to the clinical procedure envisioned for the instrument 100. As a first example, the steerable section 12 can be configured to bend relative to the longitudinal axis 18 as required by a particular clinical procedure. As a second example, the steerable section 12 can be configured to generate an appropriate radius of curvature relative to the longitudinal axis 18 for a particular clinical procedure (e.g., as the tip 16 flexes following manipulation of the steerable sheath 10). As a third example, the outer diameter D1 defined by the steerable sheath 10 can be sized appropriately for a particular natural orifice associated with a particular clinical procedure. As a fourth example, the transmission section 14 can be long enough to deliver the tip 16 of the steerable section 12 to an anatomical region associated with the clinical procedure (e.g., via a bodily insertion method such as that shown in FIGS. 17-20 ). In a fifth example, the length of the steerable section 12 may be defined according to the particular natural orifice associated with a particular clinical procedure, or in other words, the aforementioned bends and radii of curvature appropriate for a particular clinical procedure. As a sixth example, the steerable sheath 10 may have a wall thickness T1 necessary to accommodate the flexible tubing 72 within the lumen 18, while also being operable to aspirate stones (in some cases kidney stones), stone fragments, or other internal material from the lumen 18 upon opening.

[0048] By way of non-limiting example, the steering sheath 10 may be configured for flexible ureteroscopic procedures. In such a configuration, the steering section 12 may be positioned to bend at bidirectional angles of 180 degrees to 270 degrees relative to the longitudinal axis 18. The steering section 12 may be positioned to provide a radius of curvature of 15 millimeters to 30 millimeters. The outer diameter D1 of the steering sheath 10 may be between 2 and 3 / 10 millimeters and 4 millimeters. The length of the transmission section 14 may be between approximately 700 millimeters and 800 millimeters. The length of the steering sheath 10 may be long enough to allow the bidirectional angles described above at the radii of curvature described above. The wall thickness T1 may be between approximately 1 / 20 millimeter and 1 / 5 millimeter.

[0049] In some embodiments, the steerable sheath 10 (or in some cases, the steerable section 12 in particular) includes a jacket along the exterior of the steerable sheath 10. In some arrangements, the jacket can be configured to provide a lubricious outer coating that facilitates insertion into one or more natural orifices for various clinical procedures. In some arrangements, the jacket can be configured to provide a gap between itself and the outer diameter D1 of the steerable sheath 10. In this sense, the jacket can be configured to allow the passage of irrigant flow between the jacket and the outer surface of the steerable sheath 10. Advantageously, such a configuration can be beneficial for flushing debris or regulating intrarenal pressure. In some embodiments, the steerable sheath 10 includes radiopaque markers that allow visualization via external fluorescent imaging modalities.

[0050] 9-12B, an exemplary implementation of the steering sheath 10 is illustrated, according to some embodiments. As described in more detail below, the steering sheath 10 can include a concentric tube structure having concentric nested tubes, and actuation of the steering section 12 can be performed through application of axial "push" and "pull" forces to the concentric tubes. In other words, actuation of the steering section 12 of the steering sheath 10 (and thus flexion of the tip 16) can be achieved through an agonistic-antagonistic concentric tube actuation configuration. In such a configuration, the steering sheath 10 includes an outer tube 30 and an inner tube 28 disposed within the outer tube 30. The inner tube 28 and the outer tube 30 can each define an outer dimension having a diameter between 50 micrometers and 200 micrometers. For example, the inner tube 28 and the outer tube 30 may be configured to define a first inner diameter D2 suitable for aspiration of stones, stone fragments, or other body material when the insert assembly 70 is removed. In some arrangements, the inner tube 28 and the outer tube 30 are constructed of superelastic Nitinol. In other arrangements, the inner tube 28 and the outer tube 30 are fabricated from some other suitable material, including, but not limited to, polyimide, PEBAX, nylon 12, HDPE, LDPE, or any number of clinical-grade biocompatible thermoplastics or thermosets.

[0051] In such an agonist-antagonist configuration, the steering sheath 10 may implement asymmetric stiffness between the inner tube 28 and the outer tube 30. In other words, the inner tube 28 and the outer tube 30 may be configured to exhibit distinct first and second neutral axes 32, 34 (as shown with respect to FIGS. 10A and 10B ), each offset from the geometric axis 19 of the steerable section 12 of the steering sheath 10. The asymmetric stiffness between the inner tube 28 and the outer tube 30 may permit drivable bending (in a single plane or multiple planes) along the steering section 12. The inner tube 28 and the outer tube 30 may be joined at their distal ends (e.g., at the distal end 16) and rotationally aligned such that the first and second neutral axes 32, 34 oppose each other. Thus, when a differential force is applied to the inner tube 28 and the outer tube 30, the steerable section 12 may bend bidirectionally in response to the differential force.

[0052] As an example of a differential force for such an agonist-antagonist configuration, the inner tube 28 may be "pulled" in a first axial direction 42 without applying a corresponding force to the outer tube 30, thereby bending the steerable section 12 in a first curved path 46, as shown with respect to FIGS. 8A and 8B. As another example, the inner tube 28 may be "pushed" in a second axial direction 44 (opposite the first axial direction 42) without applying a corresponding force to the outer tube 30, thereby bending the steerable section 12 in a second curved path 48, as shown with respect to FIGS. 9A and 9B. As yet another example, the "pushing" and / or "pulling" described above may be applied to the outer tube 30 rather than the inner tube 28. As yet another example, a force may be applied to each of the inner tube 28 and the outer tube 30 such that the resulting force on the steering sheath 10 is differential (e.g., the inner tube 28 is "pushed" while the outer tube 30 is "pulled," the inner tube 28 is "pulled" while the outer tube 30 is "pushed," the inner tube 28 and the outer tube 30 are each "pulled" to a different extent, the inner tube 28 and the outer tube 30 are each "pushed" to a different extent, etc.).

[0053] In some embodiments, the aforementioned "pushing" and / or "pulling" of outer tube 30 and / or inner tube 28 may be provided by a mechanical transmission disposed in or on handle 20. As described in more detail below with respect to Figures 14A and 14B, the mechanical transmission may be actuated by steerable sheath control member 26.

[0054] In some embodiments associated with agonist-antagonist configurations, asymmetric stiffness is achieved by laser micromachining a first cut pattern 38 on one side of the inner tube 28 and a second cut pattern 40 on one side of the outer tube 30. The first cut pattern 38 and the second cut pattern 40 may reduce the bending stiffness (respectively) of each of the inner tube 28 and the outer tube 30. By providing the first cut pattern 38 and the second cut pattern 40 in an asymmetric manner (e.g., at different "cut percentages," different "cut densities," or at different intervals along the length of the steering section 12), the bending stiffness properties of each of the inner tube 28 and the outer tube 30 may be reduced relative to one another, resulting in asymmetric stiffness between the inner tube 28 and the outer tube 30. In other words, the first cut pattern 38 in the inner tube 28 may result in the first neutral axis 32 being offset from the central axis 36, and the second cut pattern 40 in the outer tube 30 may result in a first neutral axis 34 that is different from the first neutral axis 32 and offset from the central axis 36.

[0055] As described above, the steering portion 12 can exhibit a constant curvature when the tip 16 flexes, or the steering portion 12 can exhibit a variable curvature. As an example of providing the steering portion 12 in a configuration that exhibits a variable curvature, the first cut pattern 38 and the second cut pattern 40 can be provided in a manner that increases in density along the length of the first cut pattern 38 and the second cut pattern 40 to the tip 16. In such an example, the overall stiffness of the steering portion 12 can decrease toward the tip 16 such that the steering tip 16 flexes according to a distal flex rate (associated with a portion of the steering section 12 closer to the steering tip 16) that is greater than a proximal flex rate (associated with the steering section 12 closer to the power transmission section 14). As another example, the first cut pattern 38 and the second cut pattern 40 can be provided in a manner that decreases in density along the length of the first cut pattern 38 and the second cut pattern 40 to the tip 16. In such an example, the overall stiffness of the steerable section 12 may increase toward the tip 16 such that the steerable tip 16 flexes according to a distal flex rate (associated with a portion of the steerable section 12 closer to the steerable tip 16) that is smaller than a proximal flex rate (associated with the portion of the steerable section 12 closer to the transmission section 14).

[0056] In other embodiments associated with the agonist-antagonist configuration, asymmetric stiffness between the inner tube 28 and the outer tube 30 is achieved by selectively varying the durometer between the inner tube 28 and the outer tube 30, at least with respect to portions of the inner tube 28 and the outer tube 30 corresponding to the steering section 12. In this sense, asymmetric stiffness between the inner tube 28 and the outer tube 30 can be achieved by similarly providing offset neutral axes, such as the first neutral axis 32 and the second neutral axis 34, through selectively varying the durometer between the inner tube 28 and the outer tube 30.

[0057] In other embodiments associated with agonist-antagonist configurations, asymmetric stiffness between the inner tube 28 and the outer tube 30 is achieved by selective ablation or integration of materials of the inner tube 28 and the outer tube 30. In such embodiments, at least with respect to the portions of the inner tube 28 and the outer tube 30 corresponding to the steerable section 12, the inner tube 28 and the outer tube 30 may be constructed as one or more layers (e.g., a polymer liner layer, a polymer jacket layer, a braided reinforcement layer, some combination thereof, etc.). By way of example, offset neutral axes, such as a first neutral axis 32 and a second neutral axis 34, may also be established through selective ablation of one or more layers of each of the inner tube 28 and the outer tube 30. In another example, offset neutral axes such as first neutral axis 32 and second neutral axis 34 may similarly be provided in each of inner tube 28 and outer tube 30 by integrating axial portions of layers (e.g., axial braided members in the case of a braided reinforcement layer) to form a rigid "backbone."

[0058] 11-13, an alternative implementation of the steering sheath 10 is illustrated, according to some embodiments. As described in more detail below, the steering sheath 10 includes a first pull wire (e.g., cable) 50 and a second pull wire 52, each coupled to the distal end 16 of the steering sheath 10, and actuation of the steering sheath 10 may be accomplished through application of a "pulling" force to the first pull wire 50 or the second pull wire 52. In other words, actuable bending of the steerable section 12 of the steering sheath 10 (and thereby flexion of the distal end 16) may be achieved through pull wire actuation. The first and second pull wires 50, 52 may be disposed within the lumen 18 of the steering sheath 10 and extend along the length of the steering sheath 10. At one end, the first and second pull wires 50, 52 may be coupled to the distal end 16 (e.g., via welding, adhesive, or mechanical crimping). At the other end, first and second pull wires 50, 52 may be coupled to a mechanical transmission disposed at or within handle 20. The mechanical transmission may be actuated by steerable sheath control member 26, as described in more detail below with reference to Figures 16A and 16B.

[0059] In some embodiments relating to pull wire actuation, the first and second pull wires 50, 52 are positioned within the lumen 18 at different circumferential locations to provide actuatable bending, as described below. For example, and as shown, the first pull wire 50 may be positioned at or near a first inner diametric end of the lumen 18, while the second pull wire 52 is positioned at or near a second, different diametric end of the lumen 18, opposite the first diametric end. The first and second pull wires 50, 52 may be constrained within a liner tube inside the steering sheath 10 to prevent lateral displacement during actuation, as described below. The first and second pull wires 50, 52 may be constructed of any suitable material exhibiting high tensile strength. By way of example, the first and second pull wires 50, 52 may be constructed of nitinol wire, extruded or braided stainless steel wire, and Kevlar.

[0060] In some embodiments associated with a pull wire configuration, a mechanical transmission in the handle 20 can apply a differential pulling force to the first and second pull wires 50, 52. As one example, the mechanical transmission can apply a pulling force that pulls the first pull wire 50 toward the handle 20 while leaving the second pull wire 52 alone, or vice versa. As another example, the mechanical transmission can apply a first pulling force that pulls the first pull wire 50 toward the handle 20 and a second pulling force that pulls the second pull wire 52 toward the handle 20, such that the first pulling force is greater or less than the second pulling force.

[0061] In some embodiments associated with a pullwire configuration, the steering sections 12 of the steering sheath 10 can be configured to exhibit anisotropic stiffness. For example, the steering sections 12 can be configured to exhibit a lower bending stiffness at one or more diametrical portions of the steering sheath 10 than at other diametrical portions. As depicted with respect to Figures 12A and 12B, the diametrically upper and lower ends of the steering sections 12 can exhibit a lower bending stiffness than the central portion of the steering section 12.

[0062] As described above, the anisotropic stiffness of the steerable section 12, along with the different circumferential positions of the first and second pull wires 50, 52 within the lumen 18, can drive the steerable section 12 to bend when a mechanical transmission applies the above-described differential forces to the first and second pull wires 50, 52. Specifically, when the steerable sheath 10 is configured to exhibit a lower bending stiffness than other diametrical portions, by locating the first and second pull wires 50, 52 at opposite diametrical ends of the lumen 18, different differential forces can be applied to the first and second pull wires 50, 52 to cause bidirectional bending of the steerable section 12 and flexion of the tip 16, as shown with respect to Figures 12A and 12B. As particularly shown with respect to Figure 12A, the mechanical transmission can apply a pulling force to the first pull wire 50 to bend the steerable section 12 and flex the tip 16 along a first curved path 54. As shown particularly with respect to FIG. 12B, the mechanical transmission can apply a pulling force to the second pull wire 52, thereby bending the steerable section 12 and causing the tip 16 to flex along a second curved path 56.

[0063] In some embodiments associated with a pull wire configuration, and to facilitate the anisotropic stiffness of the steerable section 12 described above, the steerable section 12 can be formed as a serial linkage of tube segments 58, as shown. Interlocking linkages between the tube segments 58 allow each tube segment to pivot about an axis defined by the preceding tube segment (e.g., the tube segment furthest from the tip 16). As shown, each linkage defines the aforementioned axis in the same lateral direction, thereby facilitating bidirectional bending of the steerable section 12 when actuated. In other such embodiments, the steerable sheath 10 is constructed of a polymeric material comprising an elongated braid. In other such embodiments, the steerable sheath 10 is constructed of a metal (e.g., stainless steel, nitinol, titanium, etc.) patterned with a series of laser-machined cuts. In various configurations of the pull wire configuration, the steerable sheath 10 can be disposed within an outer jacket.

[0064] As discussed above, first and second pull wires 50, 52 may be provided to effect bidirectional bending of the steerable section 12 and flexion of the tip 16. In other words, the steerable section 12 discussed above may bend in a single degree of freedom. However, in other embodiments, the steerable section 12 may be configured to bend in any number of degrees of freedom through the use of any number of pull wires. For example, the steerable sheath 12 may be actuated to bend in two degrees of freedom by providing a third and a fourth pull wire (in addition to the first and second pull wires 50, 52), such that four pull wires may be disposed within the lumen 18 and coupled to the tip 16 and the mechanical transmission of the handle 20. The four pull wires may be spaced 90 degrees apart. In some arrangements related to this example, the steerable section 12 may have anisotropic stiffness, resulting in low bending stiffness in four regions corresponding to the four pull wires. In other arrangements, the steerable sections 12 may be provided via serial linkages as discussed above, however, each linkage may allow each tube segment to pivot about two axes defined by the preceding tube segment instead of one, thereby facilitating two degrees of freedom instead of one.

[0065] 14A and 14B, operation of the steering sheath control member 26 of the handle 20 is shown, according to some embodiments. As described above, the steering sheath control member 26 of the handle 20 can be manipulated by a user to drive bending of the steering section 12 of the steering sheath 10. Specifically, a mechanical transmission can be disposed on or within the handle 20, mate with the steering sheath 10, and actuate the steering sheath control member 26 to apply various forces to the steering sheath 10 and thereby drive the steering section 12. For example, the mechanical transmission can convert bending or translation of the steering sheath control member 26 into movement of one or more components of the steering sheath 10.

[0066] As described above, actuatable bending of the steering section 12 of the steering sheath 10 can be achieved through an agonist-antagonist concentric tube drive configuration. In such cases, the mechanical transmission can be configured as a rack-and-pinion system, a slider-crank mechanism, a lead screw, or any combination of the above, when actuated by the steering sheath control member 26. As alternatively described above, actuatable bending of the steering section 12 of the steering sheath 10 can be achieved through a pull wire drive. In such cases, the mechanical transmission can be configured as achieved by a rack-and-pinion, pulley, or capstan system, when actuated by the steering sheath control member 26.

[0067] 15-18, an example use of the instrument 100 according to some embodiments is shown. FIGS. 15-18 depict an example use of the instrument 100 in the context of a ureteroscope. However, as noted above, the instruments and methods described herein may be applied to a variety of other endoscopic contexts. Accordingly, the depictions of the instrument 100 shown with respect to FIGS. 15-18 should be considered non-limiting and otherwise exemplary in nature. As shown particularly with respect to FIG. 15, the instrument 100 may include an insert assembly inserted into the handle 20 and the steering sheath 10. Thus, the flexible tube 72 may extend within the lumen 18 of the steering sheath 10, such that endoscopic instruments (such as the image sensor 76, light source 76, working conduit 73, and / or irrigation conduit 79) facilitated by the flexible tube 72 may interface with the distal end 16 of the steering sheath 10. Thus, the illustrated instrument 100 may be operable as a flexible endoscope, or, more particularly, a flexible ureteroscope.

[0068] For example, as shown particularly with respect to Figures 15 and 16, the steerable sheath 10 and flexible tube 72 may be guided through the bladder 62 and ureter 64 until the tip 16 of the steerable sheath is located within the calyx 66 of the kidney 68. In some cases, this may involve utilizing an image sensor 76 and light source 78 on the flexible tube 72 for visualization of various body cavities and / or actuating the steerable section 12 of the steerable sheath 10 to form various curvatures to facilitate guiding the steerable sheath 10 and the flexible tube 72 therein. Once the tip 16 is located within the calyx 66, the image sensor 76, light source 78, and actuation of the steerable section 12 may be used to identify and guide the tip 16 toward the kidney stone 65 to engage and remove it from the calyx 66.

[0069] In some cases, the kidney stone 65 may be determined to be small enough for instantaneous aspiration, at which point the illustrative example of the instrument 100 may proceed directly to the steps discussed below with reference to Figures 18 and 19. However, if the kidney stone 65 is too large for instantaneous aspiration, a laser lithotripsy procedure may be performed, as discussed below with reference to Figures 16 and 17, before proceeding with the aspiration of the kidney stone 65.

[0070] As shown particularly with respect to FIG. 16 , a laser instrument 17 may extend from the working conduit 73 of the flexible tubing 72 to perform a laser lithotripsy procedure (e.g., breaking up the kidney stone 65 into smaller fragments). In some cases, the laser instrument 17 may be stored within the working conduit 73 throughout the process of guiding the steering sheath 10 and flexible tubing 72 to the kidney stone 65. In other cases, once the tip 16 reaches the kidney stone 65, the laser instrument 17 may be inserted into a tool and / or irrigation port 77, guided within the working conduit 73, and extend from the tip 16 as shown. Once the laser instrument 17 is engaged with the kidney stone 65 as shown, the laser instrument 17 may be controlled to break up the kidney stone 65 into fragments small enough to be aspirated from the cup 66, as shown with respect to FIGS. 18 and 19 . At some preceding or subsequent point, irrigation agent may also be provided via the tool and / or irrigation port 77 so that the irrigation agent flows through the irrigation line 79 and out the tip 16 to assist in any of the above processes.

[0071] 18 and 19, once the kidney stone 65 has been sufficiently broken into fragments via the laser lithotripsy procedure discussed above with reference to FIGS. 15 and 16 (or in cases where the kidney stone 65 is determined to be small enough for instantaneous aspiration as described above), the insert assembly 70 may be removed from the steerable sheath 10 and handle 20, thereby opening the lumen 18, for performing an aspiration procedure to remove the kidney stone 65 (or its fragments) from the cup 66. For example, an external vacuum may be coupled to the aspiration port 29. The handle 20 may include various manifolds necessary to connect the steerable sheath inner lumen 18 of the steerable sheath 10 to the aspiration port 29. When an external vacuum is applied to draw through the suction port 29 in communication with the lumen 18 of the steering sheath 10, the kidney stone 65 (or fragments thereof) near the tip 16 is drawn into the lumen 18 of the steering sheath 10 through the steering tip 16, moves along the lumen 18 of the steering sheath 10, and can be removed by the external vacuum through the suction port 29.

[0072] 21 and 22, instrument 200 is shown according to several alternative embodiments of the present disclosure. Instrument 200, like instrument 100, may include a steering sheath and insert assembly 70, and in some cases, a handle 20. However, in such alternative embodiments of instrument 200, insert assembly 70 may be permanently attached to the steering sheath (and in some cases, handle 20). For example, as generally described herein with respect to instrument 100, insert assembly 70 may be inserted into steering sheath 10 and handle 20 to provide a configuration operable as a ureteroscope (e.g., by providing an image sensor 76, a light source 78, a working conduit 73, and / or an irrigation conduit 79 at the distal end 16 of steering sheath 10 via flexible tubing 72). Insert assembly 70 may then be removed from steering sheath 10 and handle 20 to leave lumen 18 of steering sheath 10 open to provide an operable suction configuration. However, in alternative embodiments of the instrument 200 in which the insert assembly 70 is permanently attached to the steerable sheath 10, the instrument 100 may still be used to aspirate kidney stones (e.g., without removing the insert assembly 70 from the steerable sheath 10).

[0073] In such an embodiment of the device 200 in which the insert assembly 70 is permanently attached, the steering sheath 10 may include a concentric tube structure having concentric nested tubes, and actuation of the steering section 12 may be performed through application of axial "push" and "pull" forces to the concentric tubes. As described above with reference to Figures 9-12B, actuable bending of the steering section 12 of the steering sheath 10 (and thereby flexion of the tip 16) may be achieved through the agonistic and antagonistic concentric tube actuation configurations described.

[0074] In such embodiments of the instrument 200 in which the insert assembly 70 is permanently attached, various tools facilitated by the flexible tube 72 may be fixedly attached to the distal end 16 of the steering sheath. For example, an end cap 80 disposed on the end 74 of the flexible tube 72 may be attached to the distal end 16 of the steering sheath 10. For example, the end cap 80 may be attached to the distal end 16 by nesting the end cap 80 within the inner tube 28 of the steering sheath 10 (in such an agonist-antagonist concentric tube drive configuration). In another example, the end cap 80 may be attached to the outer tube 30 along with the inner tube 28 in a butt joint configuration. In still other examples, the end cap 80 may be attached to the distal end 16 via a biocompatible adhesive, mechanical crimping, welding, or soldering. In other arrangements, the end 74 of the flexible tube may be directly attached to the distal end 16 of the steering sheath 10 (rather than via the end cap 80) using the fastening methods described above.

[0075] In such embodiments of the instrument 200 to which the insert assembly 70 is permanently attached, the working conduit 73 may be appropriately sized to perform kidney stone aspiration. For example, the working conduit 73 may define a fourth inner diameter D5 of approximately 2 millimeters or greater, thereby providing an effective conduit for delivery of one or more first endoscopic tools described above and / or for aspiration of stones or other body material through the working conduit 73. Furthermore, the steering sheath 10 may define an outer diameter D1 of 2-3 / 10 to 4 millimeters, with a wall thickness T2 of approximately 1 / 20 to 1 / 5 millimeter. In this sense, the working conduit 73 may be large enough to aspirate kidney stones while also being appropriately sized to facilitate the movement of the flexible tubing 72 through the steering sheath 10 during navigation through a natural orifice associated with an endoscopic or ureteroscopic procedure, as discussed above. Depending on the implementation, the working conduit 73 may be in communication with an external vacuum via the suction port 29 or the tool / irrigation port 77.

[0076] Thus, while specific embodiments of the present invention have been described for novel and useful endoscopic aspiration methods and devices, it is not intended that such references be construed as limitations on the scope of the invention. [Explanation of symbols]

[0077] 10 Steerable sheath 12 Steering performance classification 14 Transmission Classification 16 Tip 17 Laser equipment 18 lumen 19 axis 20 Handle 21 Main Unit 22 Hub 24 Steerable Sheath Control Module 26 Steerable sheath control member 28 Proximal opening / inner tube 29 Suction port 30 outer tube 32 1st neutral axis 34 Second neutral axis 36 Center axis 38 First Cutting Pattern 40 Second Cut Pattern 42 1st axis direction 44 Second axis direction 46 First curved route 48 Second curved route 50 First pull wire 52 Second pull wire 54 First curved route 56 Second curved route 58 tube segments 62 Bladder 64 Ureter 65 Kidney stone 66 cups 68 Kidneys 70 Insert Assembly 71 Insert Assembly Control Module 72 Flexible Tube 73 Working conduit 74 End 75 Power Line 76 Image Sensor 77 Tool and / or cleaning ports 78 Light source 79 Cleaning Pipe 80 End Cap 81 Button 100 Equipment 200 Equipment D1 Outer diameter D2 1st inner diameter D3 Second inner diameter D4 Third inner diameter D5 4th inner diameter T1 wall thickness T2 wall thickness

Claims

1. a handle including a passage; a steerable sheath disposed on the handle, the steerable sheath including a lumen, a distal end, and a steerable section that is actuatable to form a bend such that the distal end is operable to be steered to an anatomical region within a patient's body; a flexible tube including an end portion; a light source disposed at the end; an image sensor disposed at the end; Equipped with the flexible tube is configured to be inserted into the lumen and the passageway such that the light source and the image sensor are located at or near the distal end; the flexible tube is configured to be removed from the lumen such that the lumen is operable to aspirate body matter from the anatomical region through the tip. Instruments used to perform endoscopic surgery inside a patient's body.

2. The device of claim 1 , wherein the steering sheath has a wall thickness of about one-twentieth to one-fifth of a millimeter.

3. The device of claim 2, wherein the steering sheath has an outer diameter of about 2 3 / 10 millimeters to about 4 millimeters.

4. The instrument of claim 1 , wherein when the flexible tube is removed from the lumen, the lumen is further operable to deliver one or more first tools to the anatomical region to cleanse the anatomical region.

5. the flexible tube includes a working conduit configured to deliver one or more second tools to the anatomical region and an irrigation conduit configured to irrigate the anatomical region; a first inner diameter of the lumen that is larger than each of a second inner diameter of the working line and a third inner diameter of the irrigation line; 10. The device of claim 1.

6. 10. The device of claim 1, wherein the handle further comprises a suction port in communication with the lumen and an external vacuum device such that the lumen is operable to aspirate body material from the tip to the suction port.

7. the steering sheath includes a concentric tube structure having nested concentric tubes; Actuation of the steerable section is performed through application of axial pushing and pulling forces to the concentric tubes.

10. The device of claim 1.

8. the steering sheath includes a first pull wire and a second pull wire each coupled to the tip; Actuation of the steerable section is performed through application of a traction force to the first pull wire or the second pull wire.

10. The device of claim 1.

9. providing a steerable sheath including a steerable section, a lumen, and a tip; providing a flexible tube including an end portion; providing a light source and an image sensor, each disposed at the end; advancing the flexible tube along the axis of the lumen so that the light source and the image source are located at or near the distal end; forming a bend in the steerable section, the bend steering the tip to an anatomical region within a patient; and retracting the flexible tube along the axis to open the lumen; aspirating an internal body material from the lumen through the distal end; A method for performing endoscopic surgery, comprising:

10. the steering sheath has a wall thickness of about one-twentieth of a millimeter to one-fifth of a millimeter; the steering sheath has an outer diameter of about 2 3 / 10 millimeters to about 4 millimeters; 10. The method of claim 9.

11. delivering one or more first tools to the anatomical region through the lumen while the lumen is in an open state; irrigating the anatomical region through the lumen while the lumen is in an open state; The method of claim 9 further comprising:

12. the flexible tube includes a working conduit configured to deliver one or more second tools to the anatomical region and an irrigation conduit configured to irrigate the anatomical region; a first inner diameter of the lumen that is larger than each of a second inner diameter of the working line and a third inner diameter of the irrigation line; 10. The method of claim 9.

13. the steering sheath includes a concentric tube structure having nested concentric tubes; forming the bend in the steerable section through application of axial pushing and pulling forces to the concentric tubes; 10. The method of claim 9.

14. the steering sheath includes a first pull wire and a second pull wire each coupled to the distal end; forming the bend in the steerable section through application of a traction force to the first pull wire or the second pull wire; 10. The method of claim 9.

15. a steerable sheath including a tip, a lumen, and a steerable section that is actuatable to form a bend such that the tip is operable to be steered to an anatomical region within the patient's body; a flexible tube including an end and a working conduit defining a fourth inner diameter of at least about 2 millimeters and operable to aspirate body matter; a light source disposed at the end; an image sensor disposed at the end; Equipped with the flexible tube is disposed within the lumen such that the end is located at or near the tip; the steerable section includes a concentric tube structure having nested concentric tubes; Actuation of the steerable section is performed through application of axial pushing and pulling forces to the concentric tubes. Instruments used to perform endoscopic surgery inside a patient's body.

16. 16. The instrument of claim 15, further comprising a handle including a passageway and a suction port in communication with the working conduit such that the working conduit is operable to aspirate the body material from the end to the suction port.

17. The device of claim 15, wherein the steering sheath has a wall thickness of about one-twentieth to one-fifth of a millimeter.

18. 17. The device of claim 16, wherein the steering sheath has an outer diameter of about 2 3 / 10 millimeters to about 4 millimeters.

19. The device of claim 15, wherein the flexible tube further comprises an irrigation line configured to irrigate the anatomical region.

20. The instrument of claim 15, wherein the working conduit is further operable to deliver one or more first tools to the anatomical region.

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