Expandable guide devices, systems and methods

Abstract

To provide expandable guide devices, implementation methods, and related delivery systems.SOLUTION: Embodiments according to the present disclosure, including as described herein, may increase the effectiveness and efficiency of endoscopy procedures. In one example, an expandable guide device is configured to receive an instrument through an instrument lumen of the device, where the device comprises first and second bodies, with first and second expandable members disposed about the first and second bodies.SELECTED DRAWING: Figure 1C

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices and, more particularly, to expandable guide devices and related systems and methods, particularly those that can enhance the effectiveness and efficiency of endoscopic procedures. [Background technology]

[0002] Endoscopes are used in medical procedures to examine and treat conditions within the digestive tract, for example. ERCP procedures are used to examine and treat problems in the common bile duct and pancreatic duct. In some procedures, cannulation of the bile duct can be difficult, and movement within the duodenum makes positioning and stabilization of the endoscope difficult to achieve. Furthermore, the tightly contracted musculature of the duodenal papilla requires a high level of precision to maneuver through the papilla opening. As a result, the effectiveness and efficiency of the procedure can be compromised, and the difficulty of cannulating the common bile duct can result in multiple attempts or failed attempts.

[0003] With the above considerations in mind, improvements to the present disclosure may be useful. Summary of the Invention

[0004] The present disclosure, in its various aspects, is generally directed to expandable guide devices, implementation methods, and related systems. Embodiments according to the present disclosure, including those described herein, can, among other things, increase the effectiveness and efficiency of procedures used to examine and treat conditions within the body, such as cannulation of the bile duct during ERCP.

[0005] In one aspect, an embodiment of the present disclosure describes an expandable guide device. The guide device may include a first body having a proximal end, a distal end, and an instrument lumen extending through the first body along a longitudinal axis. The instrument lumen may be configured to slidably receive a first length of an expandable instrument therethrough. The first body may be configured to resist deformation. A first expandable member may be disposed about the first body. A second body may have a proximal end, a distal end, and an instrument lumen extending through the second body along a longitudinal axis. The instrument lumen may be configured to slidably receive a second length of an expandable instrument therethrough, and the second expandable member may be disposed about the second body.

[0006] In various embodiments described herein and otherwise within the scope of the present disclosure, the first and second expandable members can include a flexible expandable material. The device can further include at least one delivery member in fluid communication with at least one of the first and second expandable members. The at least one delivery member can be in fluid communication with both the first and second expandable members. The at least one delivery member can be a CO 2The second body may be in fluid communication with a source of contrast fluid, a shear thinning material, or air. The second body may include a flexible expandable material. The instrument lumen of the second body may be configured for frictional contact with the instrument. The first expandable member may comprise a plurality of chambers. Each chamber of the plurality of chambers may comprise an independent one of the at least one delivery member, and each chamber may be independently expandable relative to other chambers of the plurality of chambers. The first expandable member may further comprise a sensor. A central axis of the first body may be offset from a central axis of the first expandable member when the first expandable member is in an expanded configuration. The first body may comprise a first expandable member disposed about an outer surface of the first body and a third expandable member disposed about an inner surface of the first body. The inner surface of the first body may further comprise a lubricious coating. The at least one delivery member may be in fluid communication with the first expandable member and the second expandable member. The distance between the first body and the second body can be fixed. The device can further include an elongate member disposed along an exterior surface of the first body, the elongate member including a second lumen extending therethrough. The first expandable member, or the second expandable member, or both, can be spherical, elliptical, or ellipsoidal in shape.

[0007] In one aspect, an embodiment of the present disclosure describes a system that may include an instrument and an expandable guide device. The device may be slidably disposed about the instrument and may include a body having a proximal end and a distal end. The body may be configured to resist deformation. A first expandable member may be disposed about an outer surface of the body. A second expandable member may be disposed about an inner surface of the body. The second expandable member may define an instrument lumen, which may extend through the body along a longitudinal axis. The instrument may be configured to slidably receive an extendable length of the instrument therethrough.

[0008] In various embodiments described herein and otherwise within the scope of the present disclosure, the first expandable member and the second expandable member can be configured to be expanded independently of one another. In one aspect, an embodiment of the present disclosure describes a method that may include coupling an expandable guide device with an instrument. The instrument may include a first expandable member and a second expandable member. The method may include inserting the instrument and the device into a body lumen and advancing the instrument and the device toward a treatment site. The method may further include expanding the first expandable member against a wall of the body lumen.

[0009] In various embodiments described herein and otherwise within the scope of the present disclosure, expanding the first expandable member may allow longitudinal and rotational movement of the instrument relative to the expandable guide device. The method may further include expanding the second expandable member to provide lateral stabilization of the instrument relative to the body lumen. The first expandable member may be expanded to position the instrument in a fixed position to interact with the treatment site, and the second expandable member may be expanded to laterally stabilize the instrument relative to the body lumen.

[0010] Non-limiting examples of the present disclosure are described by way of example with reference to the accompanying figures. The accompanying figures are schematic and are not intended to be drawn to scale. In the figures, each identical or nearly identical component shown is typically represented by a single numeral. For clarity, not every component will be labeled in every figure, nor will every component of each embodiment of the present disclosure be shown unless illustration is necessary to enable a person skilled in the art to understand the present disclosure. The figures are as follows: [Brief description of the drawings]

[0011] [Figure 1A] 1 illustrates an exemplary instrument of the type described in embodiments of the present disclosure. [Figure 1B] 1 shows a partial cross-sectional view of an endoscope inside a body. [Figure 1C] 1 illustrates an exemplary expandable guide device in an expanded configuration, according to one embodiment of the present disclosure. [Figure 1D]1D shows a partial cross-sectional view of an endoscopic system having the expandable guide device of FIG. 1C in an expanded configuration, according to one embodiment of the present disclosure. [Figure 1E] 1C and 1D show cross-sectional views of the expandable guide device of FIG. 1C and FIG. [Figure 1F] 1C-1E show cross-sectional views of the expandable guide device of FIG. 1C-E in an expanded configuration. [Figure 2A] 1 shows a perspective view of an expandable guide device in an expanded configuration according to one embodiment of the present disclosure. [Figure 2B] 2B shows a perspective view of the expandable guide device of FIG. 2A in an unexpanded configuration. [Figure 2C] 1 shows a perspective view of an expandable guide device in an expanded configuration according to one embodiment of the present disclosure. [Figure 3A] 1 shows a perspective view of an expandable guide device in an expanded configuration according to one embodiment of the present disclosure. [Figure 3B] 3B illustrates a cross-sectional view of the expandable guide device of FIG. 3A in an unexpanded configuration. [Figure 3C] 3B shows a cross-sectional view of the device of FIG. 3A. [Figure 3D] 1 shows a cross-sectional view of an expandable guide device with two bodies according to one embodiment of the present disclosure. [Figure 3E] 1 shows a cross-sectional view of an expandable guide device with a central expandable member according to one embodiment of the present disclosure. [Figure 3F] 1 shows a cross-sectional view of an expandable guide device in an expanded configuration according to one embodiment of the present disclosure. [Figure 3G] 1 shows a cross-sectional view of an expandable guide device in a locked configuration according to one embodiment of the present disclosure. [Figure 4A] 1 shows a perspective view of an expandable guide device in an expanded configuration according to one embodiment of the present disclosure. [Figure 4B] 4B shows a cross-sectional view of the device of FIG. 4A. [Figure 5A] 1 shows a perspective view of an expandable guide device in an expanded configuration according to one embodiment of the present disclosure. [Figure 5B]5B illustrates a cross-sectional view of the expandable guide device of FIG. 5A in a partially unexpanded configuration. [Figure 5C] 5A and 5B, showing a side view of the expandable guide device of FIG. 5A and FIG. 5B, with the expandable member in various states of expansion, according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Generally, in any form of endoscopy or other procedure, when any other instrument is inserted into the body, it may be important to be able to stabilize the instrument in place as it is navigated to a desired location, to position the instrument at a particular radial location defined by a cross-section of the body lumen, to orient the instrument in a particular manner as dictated by a particular procedure, etc.

[0013] Various embodiments according to the present disclosure are described below: As used herein, "proximal end" refers to the end of the device that is located along the device closest to the medical professional when the device is introduced into a patient, and "distal end" refers to the end of the device or object that is located along the device furthest from the medical professional when implanting, positioning, or delivering.

[0014] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0015] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include one or more particular features, structures, and / or characteristics. However, such a description does not necessarily mean that all embodiments include the particular feature, structure, and / or characteristic. In addition, if a particular feature, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated to the contrary.

[0016] This detailed description should be read with reference to the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0017] The embodiments of the present disclosure may include an expandable guide as a device for use with an instrument. The instrument may be an endoscope, duodenoscope, colonoscope, bronchoscope, gastroscope, ureteroscope, catheter, tube, etc. The device may include various components and configurations. The embodiments of the present disclosure may include a system. The system may include an instrument, an expandable guide device, a handle extending to the expandable guide device, and / or an inflation fluid source, etc. The device and system embodiments may be used to substantially fill a body lumen around the instrument during an endoscopy procedure and allow an operator to stabilize or position the instrument within the body lumen. Various embodiments described herein include an expandable guide device having at least one expandable member around a body forming an instrument lumen, the instrument lumen being capable of slidably receiving an extendable instrument length therethrough. The expandable member, when expanded within the body lumen, may inhibit one or more of lateral, rotational, or straight-line movement of the instrument within the body lumen. In some embodiments, the expandable member may include an inflatable balloon and the inflation fluid may be a fluid, such as a gas, liquid, or both. In some embodiments, the body lumen may include a lumen, organ, blood vessel, passageway, etc., such as within the digestive system. In various embodiments, the distal end of the instrument may or may not extend beyond the distal end of the expandable guide device. In various embodiments, the expandable member may expand to a greater or lesser extent, may assume a different shape, and / or may exhibit other properties different from another expandable member. In various embodiments, the expandable guide device may be disposable. In alternative embodiments, the expandable guide device may be reusable.

[0018] ERCP is used to access, examine, and treat problems in the common bile duct and pancreatic duct. An endoscope may be introduced into a patient through the stomach, for example, via the mouth, and advanced through at least a portion of the small intestine. The endoscope may be used to access the ampulla of Vater or papilla of Vater to reach the pancreatic and bile ducts. Positioning and / or the angle of entry of the endoscope relative to the duodenal papilla may be important to the success of the procedure and may be made difficult by patient movement and breathing, duodenal movement, and / or manipulation of tools within or associated with the endoscope. In order for a user to perform ERCP, the distal end of the instrument must be sufficiently stabilized within the body lumen at the ampulla of Vater or papilla of Vater, which requires great precision. Once in place, the instrument (e.g., endoscope) needs to be held sufficiently stable to facilitate access and entry into and through the ampulla of Vater by the instrument and / or by an accessory device (e.g., biopsy tool) delivered through the working channel of the instrument and / or expandable guide device.

[0019] Many medical procedures, including endovascular procedures, procedures along the digestive tract, urinary tract, airways, reproductive organs, and / or bile ducts, thoracic and pulmonary procedures, etc., utilize instruments such as endoscopes to access tissues intended for diagnosis or treatment within the body (e.g., "target tissues"). In some cases, endoscopes can incorporate features that assist the physician in visualizing and performing treatments on the tissue. For example, some endoscopes can include lights and / or cameras designed to illuminate and / or visualize the body lumen as the endoscope is navigated and positioned adjacent to the target tissue site. In addition, some endoscopes can also include lumens (e.g., working channels) through which resection devices, grasping members, or other accessory devices can be deployed and utilized. Additional visualization and / or external and / or internal imaging methods may alternatively or additionally be used (e.g., fluoroscopy).

[0020] Exemplary devices, systems, and methods in which embodiments of the present disclosure may be implemented include, but are not limited to, those described in the complete disclosures of U.S. Provisional Patent Application No. 63 / 071,125, entitled "Devices, Systems, and Methods for Pyloric Occlusion," filed August 27, 2020, U.S. Provisional Patent Application No. 63 / 071,412, entitled "Stabilization and Leverage Devices, Systems, and Methods," filed August 28, 2020, U.S. Provisional Patent Application No. 63 / 083,960, entitled "Expandable Guide Devices, Systems, and Methods," filed on the same day herewith, and U.S. Provisional Patent Application No. 63 / 083,962, entitled "Expandable Guide Devices, Systems, and Methods," filed on the same day herewith. Each of these disclosures is incorporated herein by reference in its entirety.

[0021] Referring to FIG. 1A, one embodiment of an instrument that can be used with an expandable guide device as described herein is shown. The instrument 110, e.g., an endoscope, includes a distal end 106 and a proximal end 107 with a lumen or working channel extending therethrough. A handle 103 at the proximal end 107 can be manipulated by a medical professional to manipulate the instrument 110. The instrument 110 can include incisions or channels 104 along a wall 111 of an insertion portion (e.g., a flexible tube) of the instrument 110 to facilitate movement and flexibility of the instrument 110 within a patient, e.g., by manipulation of a steering knob at the handle 103. FIG. 1B shows the instrument 110 (e.g., a duodenoscope) within a body lumen 100 (e.g., the duodenum). In this view, a catheter 112 extends from the instrument 110 through the papilla of Vater 114 to remove an obstruction 116 shown in the bile duct.

[0022] As used herein to describe various embodiments within the scope of the present disclosure or otherwise, the inner surface of the body refers to the surface that faces the instrument lumen and the instrument when received therein, and the outer surface of the body refers to the surface that faces the body lumen.

[0023] 1A-1B illustrate an example of an expandable guide device for use with an instrument such as an endoscope. FIG. 1C illustrates an expandable guide device 140 according to one embodiment of the present disclosure. The device 140 includes a first expandable member 120 disposed about a first cylindrical body 122. The expandable member 120 is shown in an expanded configuration. The expandable member 120 extends along a longitudinal axis 170 from a distal end 134 to a proximal end 136 of the body 122. The body 122 includes an instrument lumen 130 extending therethrough between the distal end 134 and the proximal end 136. A delivery member 150 is in fluid communication with the expandable member 120 and extends proximally away from the body 122. To improve axial movement of instruments within instrument lumen 130, a lubricious coating (e.g., KY Jelly, silicone oil, Teflon, bonded hydrophilic coatings (e.g., ZGlide™), combinations thereof, etc.) may be applied along the inner surface of body 122. To achieve a similar purpose as the hydrophilic coating, the inner surface of body 122 may alternatively or additionally be configured with ball or roller bearings. Additionally, positive pressure of a penetrating fluid on or between the surfaces may be used to create a frictionless cushion. Contact area minimizing structures such as ridges or bumps on the surfaces may also be used.

[0024] 1D shows the device 140 of FIG. 1C positioned about the instrument 110 in an expanded configuration within the body lumen 100. The expandable member 120 is expanded against the wall of the body lumen 100, thereby aiding in the stability of the instrument 110. Stability is achieved relative to the surrounding anatomical structures, allowing for more efficient and stable movement of the catheter 112 within the papilla 114 and access to the obstruction 116. The expandable member 120 facilitates axial and rotational movement of the instrument 110 within the body of the device, while substantially preventing radial or lateral movement within the body lumen 100.

[0025] In various embodiments described herein or otherwise within the scope of the present disclosure, the expandable guide device may include an expandable member. The expandable guide device may include one or more expandable members. The one or more expandable members may be an internal expandable member and / or an external expandable member. The expandable member may be segmented or chambered. Each segment or chamber may be independently expandable. The expandable member may affect different shapes of the expandable member around the circumference of the device, for example, by maintaining various chambers of the expandable member in an unexpanded state, by partially expanding, or by expanding. The expandable member may include a flexible expandable material such as silicone, latex, rubber, polyurethane, combinations thereof, and the like. The expandable member may be mechanically actuated, electrically actuated, pneumatically actuated, and inflated. The expandable member may transition from a non-expanded configuration to an expanded configuration (including a partially expanded configuration) to occlude, stretch, establish patency of, or maintain patency of a body lumen. The expandable members can be used to center or position the instrument within the body lumen. The expandable members can be used to manipulate tissue in the body lumen for visualization or surgery. The expandable members can be flexible or inflexible and can be spherical, elliptical, or ellipsoidal. An embodiment can include multiple expandable members arranged around a single body. In an embodiment with multiple expandable members, each member can be independently expandable. The expandable members external to the body of the device can be used to stabilize the instrument within the body lumen, to block radial movement of the instrument, and / or to prevent linear and axial movement of the instrument within the body of the device. The expandable members internal to the body of the device can be used to grip the instrument such that any movement of the instrument will cause the expandable guide device to move with the instrument.

[0026] The expandable member or other portion of the device may include one or more radiopaque markers at various locations around and along the device. The radiopaque markers may be imaged during a procedure, allowing, for example, the position of one or more devices relative to each other, relative to an instrument, and / or relative to a portion of a body lumen to be determined, altered, confirmed, etc. The degree of expansion of the expandable member may be confirmed as well. Also, an imageable contrast fluid may be injected into the body lumen, or the inflation fluid for the expandable member may be made radiopaque. The radiopaque markers may include radiopaque fillers incorporated into the material of the expandable member, and / or separate markers may be affixed to the interior or exterior of the expandable member, to a surface of the body, or to other portions of the device.

[0027] In various embodiments described herein or otherwise within the scope of the present disclosure, the expandable guide device may include a body. The body may have a proximal end and a distal end. The body may be a flexible but non-expandable material, such as LDPE, HDPE, Pebax, Nylon, PEEK, PTFE, metal (stainless steel, NiTi, metal mesh, etc.), combinations thereof, etc. The body may resist deformation due to the relatively inelastic nature of the body's material compared to the expanding surface of the expandable member. The body may be a sheath and may not add significant thickness to the instrument. The body may form an instrument lumen. An inner surface of the body may be in frictional contact with the instrument while the instrument is within the instrument lumen. The inner surface of the body may include a lubricious coating along the instrument lumen. The body may have an elongate member as a sheath. The elongate member may extend the length of a tool or another instrument. The tool or another instrument may be insertable along the elongate member. The elongated member may be attached on the inner or outer surface of the body or between the surfaces of the body along the length of the body from the proximal end of the body to the distal end of the body. If the body extends the length of the attachment device, the elongated member may be attached along the entire length of the device. If the body is shorter and located at the distal end of the instrument, the elongated member may be attached along one or more bodies or may otherwise extend freely from the expandable guide along the outer surface of the instrument. The elongated member may include a lumen therethrough. The lumen may be configured to slidably receive a tool, for example, as an attachment of an instrument within the instrument lumen of the body and / or as an attachment of another tool passing through the working channel of the instrument (e.g., an endoscope working channel).

[0028] In various embodiments described herein or otherwise within the scope of this disclosure, the expandable members of the expandable guide device may have a fluid inlet that may extend through the outer surface of the expandable member. The fluid inlet may provide a fluid path that may supply and / or return inflation fluid for expanding and / or de-expanding the expandable member, for example, when the expandable member is a balloon. Each expandable member may have its own independent or shared fluid inlet and corresponding delivery member. At least one delivery member may extend along the outside of the device to the proximal end of the device. Each expandable member may have an individual delivery member, or one delivery member may extend to multiple expandable members. The delivery members may extend along the device in a single conduit. Alternatively, the body may be a sheath that extends the length of the device, and the delivery members are embedded within the sheath. In embodiments with multiple expandable members, one delivery member may be used to deliver fluid to multiple expandable members. The delivery members may also be embedded within the body, or independently. At least one delivery member is 2 , contrast fluid, or air.

[0029] 1E and 1F show cross-sectional views of the expandable guide device 140 of FIGS. 1C and 1D slidably disposed about the instrument 110. In FIG. 1E, the expandable member 120 is in an unexpanded configuration about the body 122. The instrument 110 is slidably disposed within the instrument lumen 130 of the body 122. FIG. 1F shows the expandable member 120 in an expanded configuration about the body 122. While the instrument 110 is slidably disposed within the instrument lumen 130, the flexible expandable member 120 expands to fill the body lumen. When expanded, the expandable guide device 140 facilitates axial and rotational movement of the instrument, but not radial movement. This allows the user to control the positioning and / or entry angle of the instrument with greater precision during a procedure, such as a cannulation procedure, reducing the chance of losing positioning and maintaining stability when performing exchanges and procedures.

[0030] In various embodiments described herein and otherwise within the scope of the present disclosure, a stylet may also extend through the actuation or delivery member of the device, for example, from a handle portion of the guide device held at the proximal end of the instrument. The stylet can be used to push and / or pull the device in conjunction with or against the instrument to position or reposition the device along and around the surface of the instrument. The stylet holds the device in a fixed position while only the instrument is moved relative to the instrument, or vice versa. When the stylet is used to move the device relative to the instrument, or when the guide device and instrument are moved in conjunction, the expandable member can partially expand or de-expand. Movement of the device along and around the instrument can be in a distal or proximal direction. Alternatively, the expandable member can be expanded and the stylet used to hold the device in a fixed position, and the instrument can be moved through the body lumen while the expanded expandable member holds the body lumen stable. The expandable member may be expanded to contact the body lumen, may be partially expanded when the user is positioning the device and does not want to unexpand the expandable member, and may be unexpanded when moving the device through the body lumen.

[0031] 2A and 2B show an embodiment of the expandable guide device of the present disclosure in an expanded configuration (FIG. 2A) and a non-expanded configuration (FIG. 2B). In this embodiment, there are two bodies 222a, 222b. A first device 220a is disposed closer to the distal end 214 of the instrument 210. This first device 220a comprises a first body 222a substantially similar to that of FIG. 1C, with a flexible expandable member 240a disposed about the first body 222a and a delivery member 250a in fluid communication with the expandable member 240a. A second device 220b is proximal to the proximal end 206 of the first device 220a. The second device 220b comprises a second body 222b, with an expandable member 240b disposed about the second body 222b and a delivery member 250b in fluid communication with the expandable member 240b. The expansion of each expandable member may be independent due to independent inflation fluid delivery members. The second body 222b may comprise a flexible expandable material. The first body 222a and the second body 222b are configured such that the instrument 210 can be extended therethrough. The first body 222a may comprise a lubricious inner coating that resists deformation and faces the instrument, allowing linear and rotational movement of the instrument 210. The flexible second body 222b may retract onto the instrument 210 as the expandable members 240b are expanded. Retracting relative to the instrument 210 axially fixes the instrument 210 in place relative to the second body 222b. This embodiment allows the user to achieve a desired position of the instrument 210 within the body lumen by expanding the first expandable member 240a to prevent radial movement of the instrument 210 while allowing longitudinal and rotational movement relative to the device. Once the instrument 210 is in place, the user can then expand the second expandable member 240b, which due to the flexible body 222b and the flexible material of the expandable member 240b, will expand both outwardly into the body lumen and inwardly onto the instrument 210, substantially locking the instrument 210 in place. From this position, the instrument can be stabilized within the body lumen and the bile duct papilla can be more easily accessed during a procedure, such as an ERCP procedure.

[0032] FIG. 2C shows an embodiment with two devices 220a, 220b, with the first device 220a extending distally beyond the distal end of the instrument 210. The instrument 210 is still within the instrument lumen of the first body 222. The first body 222 is moved axially straight to this position by either moving the body 222 itself straight distally relative to the instrument 210, or by moving the instrument 210 straight axially proximally from the body 222. When moving the instrument 210 straight axially proximally, the expandable member 240 of the device 220a is expanded to keep the body in place. When the expandable members 240, 241 are expanded, the body lumen is moved away from the instrument 210. This can improve the stability of the instrument and create space between the instrument 210 and the body lumen, creating more room to move the catheter 260. In the embodiment of Figure 2C, the placement of expandable members on either side of the catheter 260 allows a user to stabilize the instrument on either side of the nipple, creating a stable open space between the working channel of the instrument and the body lumen. Expansion of the expandable members can seal the area between the expandable members. Once sealed, this area can be filled with fluid, which can improve ultrasound examinations when used with an endoscopic ultrasound instrument or ultrasound probe.

[0033] 3A-3C show one embodiment of an expandable guide device of the present disclosure including an internal expandable member 360 disposed along an inward facing surface of the expandable guide device body 322 and an external expandable member 340 disposed about an outward facing surface of the body 322. The device is disposed at a distal end 314 of an instrument 310. The external expandable member 340 may be adhered to the outward facing surface of the body 322. The internal expandable member 360 may be adhered to the inward facing surface of the body 322. The internal expandable member may be disposed about the body and radially expandable from the inward facing surface. The external expandable member may be disposed about the body and radially expandable from the outward facing surface. FIG. 3A shows the device disposed about an instrument 310 with the internal expandable member 360 and the external expandable member 340 partially expanded. A first delivery member 350 extends proximally from and is in fluid communication with the outer expandable member 340. A second delivery member 352 extends proximally from and is in fluid communication with the inner expandable member 360. FIG. 3B shows a cross-sectional view of the device with both the inner expandable member 360 and the outer expandable member 340 unexpanded about the device 310. FIG. 3C shows a cross-sectional view of the device with both the inner expandable member 360 and the outer expandable member 340 expanded about the device 310. When the inner expandable member 360 is expanded, it secures the device 310 within the body 322. This secures the device 310 relative to the device 304 and allows the user to move the device 310 and device 304 in a straight line simultaneously. The outer expandable member 340 helps to secure the device 304 relative to the body lumen, pushing up against the wall of the body lumen. As with the previous embodiment, the outer expandable member can stabilize the body lumen and the instrument can continue to move within the body until it is properly positioned. Once positioned, the inner expandable member can be expanded to lock the instrument in place.

[0034] In the embodiments described herein, and in various embodiments otherwise within the scope of the present disclosure, when the inner expandable member is expanded, frictional contact can be maintained between the inner expandable member and the instrument, allowing the device to move with the instrument as the instrument is pushed or pulled through the body lumen. A stylet can also extend from a handle portion of the guide device, for example, held at the proximal end of the instrument, through the actuation member or delivery member of the device. The stylet can be used to push and / or pull the device in conjunction with or against the instrument to position or reposition the device along and around the surface of the instrument. To move the device with the stylet, the inner expandable member is unexpanded. The stylet holds the device in place when only the instrument is moved relative to the instrument. When moving the device relative to the instrument with the stylet, or when moving the guide device and instrument in conjunction, the outer expandable member can expand. Movement of the device along and around the instrument can be in the distal or proximal direction. Alternatively, the outer expandable member can be expanded and the inner expandable member is not expanded and a stylet is used to hold the device in place while the expanded outer expandable member stabilizes and holds the body lumen while allowing the instrument to be moved through the body lumen. The outer expandable member can be expanded to contact the body lumen, partially expanded when the user is positioning the instrument and does not want to unexpand the expandable member, and unexpanded when moving the instrument through the body lumen. The inner expandable member can be expanded when moving the instrument with the instrument, partially expanded when the user is positioning the instrument, and unexpanded when moving the instrument or instrument separately. Each of these expanded, unexpanded, and partially expanded configurations can be used to position, stabilize, or otherwise assist the user in manipulating the instrument within the body lumen.

[0035] In various embodiments herein or otherwise within the scope of this disclosure, both the internal and external expandable members can be annular about the body. The expandable members may be attached to the body at a single location and may not be circumferential about the body. An internal expandable member of this type can secure the device within the body. An external expandable member of this type can secure the body within the body lumen.

[0036] FIG. 3D illustrates one embodiment of an expandable guide device of the present disclosure, including an internal expandable member 360 disposed along the inner surface of the first body 324 and an external expandable member 340 disposed around the outer surface of the second body 326. The device can be operated as described above. In FIG. 3D, both the internal expandable member 360 and the external expandable member 340 are expanded, such that the internal expandable member 360 is expanded around the instrument 310. The lubricious coating on the outer surface of the first body 324 and the inner surface of the second body 326 facilitates axial and rotational movement of the first body 324 within the second body 326. When in this configuration, the external expandable member 340 is expanded into the body lumen to stabilize the body lumen. The internal expandable member 360 is expanded over the instrument 310 to stabilize the instrument 310 within the body lumen. The instrument 310 may still be moved axially and rotationally with the first body 324, allowing the user to position the instrument 310 while stabilizing the body lumen.

[0037] FIG. 3E illustrates one embodiment of an expandable guide device of the present disclosure, including an inner expandable member 360 disposed along the inner surface of the first body 324 and an outer expandable member 340 disposed around the outer surface of the second body 326. The device can be operated as described above. A central expandable member 328 is disposed between the outer surface of the first body 324 and the inner surface of the second body 326. The central expandable member 328 can be attached to either the first body 324 or the second body 326. When the inner expandable member 360 is expanded, the device 310 cannot move axially, but the device can rotate with the device 310. When the central expandable member 328 is expanded, the first body 324 and the second body 326 are prevented from rotating. The central expandable member 328 can be circumferential, e.g., an annular balloon, as shown in FIG. 3E. Alternatively, the central expandable member 328 may extend along only a portion of the circumference and / or along only a portion of the axial length of the first or second body. When the central expandable member 328 is only partially circumferential, two or more members 328 may be evenly or non-uniformly disposed and spaced around the circumference of the first or second body.

[0038] FIG. 3F illustrates one embodiment of the expandable guide device of the present disclosure. The device can be manipulated as described above to allow the instrument and the body with expandable members to move axially and rotationally, both individually and collectively, between each other and with respect to the body lumen. In this embodiment, the device includes an inner expandable member 360 disposed about the inner surface of the first body 324 and in fluid communication with an inner expandable member delivery member 345. An outer expandable member 340 is disposed about the outer surface of the second body 326 and in fluid communication with an outer expandable member delivery member 346. A central expandable member 328 is disposed between the first body 324 and the second body 326 and in fluid communication with a central expandable member delivery member 347. The expansion of each expandable member can be independent due to independent inflation fluid delivery members. The central expandable member 328 can be configured as an annular member or as a partially circumferential member(s), as described above with respect to FIG. 3E. The second body 326 has a longer length than the first body 324 and has flanges 336 extending from the distal end 370 and the proximal end 380 of the second body 326. The difference in length between the first body 324 and the second body 326 allows the first body 324 to move axially when the central expandable member 328 is not expanded. The flanges 336 prevent the first body 324 from moving axially past the second body 326. The first body 324 can be moved axially within the second body when the inner expandable member 360 is expanded to grip the instrument 310, which is moved axially while the second body 326 is held in place by the delivery member 344. Other embodiments of manipulating the device and instrument individually or together relative to each other and / or to a body lumen are envisioned.

[0039] 3G is an embodiment of an expandable guide device of the present disclosure. The device can be manipulated as described above to allow the instrument and the body having the expandable members to move axially and rotationally, both between each other and with respect to the body lumen, individually or collectively. The device includes an inner expandable member 360 disposed about an inner surface of a first body 324 and an outer expandable member 340 disposed about an outer surface of a second body 326. The second body 326 includes a protrusion 332 along the inner surface of the body 326, which protrusion 332 mates with a notch 334 on the outer surface of the first body 324. When the notch 334 and the protrusion 332 are coupled, the first body 324 and the second body 326 can move axially relative to each other, but do not have to rotate about each other. The notch 334 extends from the proximal end to the distal end of the first body and forms a groove in which the protrusion 332 (extending from the proximal end to the distal end of the second body) can slide. The distal and proximal ends of the second body 326 may have flanges that stop the first body 324 from sliding out of the second body 326. This allows the first body 324 and the second body 326 to move axially. Alternatively or additionally, the central expandable member 330 may be incorporated as an axial brake between the first body and the second body. When the central expandable member 330 is expanded, the first body 324 and the second body 326 may not slide axially relative to each other. Each of the inner expandable member 360, outer expandable member 340, and central expandable member 330 may be in fluid communication with a separate corresponding inner expandable member delivery member 345, outer expandable member delivery member 346, and central expandable member delivery member 347 (not shown), similar to the device of FIG. 3F.

[0040] In various embodiments herein or otherwise within the scope of this disclosure, multiple expandable members can be used to facilitate movement of the instrument, stabilize the instrument, and / or position the instrument. For example, as seen in FIG. 3G, the inner expandable member 360 is expanded by the inner expandable member delivery member 345. When only the inner expandable member 360 is expanded, the instrument 310 and the first body 324 may be moved axially within the second body 326, and the instrument 310, the first body 324, and the second body 326 may be moved rotationally within the body lumen. When the inner expandable member 360 and the central expandable member 330 are expanded, the first body 324 and the second body 326 move axially and rotationally with the instrument 310. When the inner expandable member 360, the central expandable member 330, and the outer expandable member 340 are expanded, the device 310, the first body 324, and the second body 326 are all locked in place, stabilizing the device within the body lumen.

[0041] In various embodiments described herein or otherwise within the scope of the present disclosure, as seen in Figures 3A-3G and 4A-4B, multiple bodies having expandable members can be used with a single instrument. It can be beneficial to have more than one body along the instrument, since the placement of the device on the instrument can provide variation in use. Furthermore, the use of an expandable guide device having a first body (e.g., first body 220a of Figure 2A) along with a second body (e.g., second body 220b of Figure 2A) facilitates different positioning or movement restriction for the body movements along different lengths of the instrument, either individually or simultaneously. For example, the embodiment of Figure 2A facilitates expansion of the distal body 220a, thereby facilitating sequential longitudinal and axial movement for the instrument, and then expansion of the proximal body 220b, thereby substantially preventing movement of the instrument 210 within the body lumen. Expandable guide devices can be strategically positioned along the instruments and relative to each other to provide steering capabilities not easily achievable with instruments without the device, such as positioning along the colonoscope in a location useful for navigating tortuous anatomy without forming undesirable loops in the endoscope.

[0042] 4A-4B show an embodiment of the present disclosure in which an expandable guide device includes an elongate member 410 including a portion 450 having a lumen 460. The device can be operated as described above. A secondary instrument 455 can be slidably moved through the lumen 460 of the elongate member 450 for use within the body lumen. FIG. 4B shows a cross-sectional view of this embodiment. The elongate member 460 extends along the outer wall of the body 422, and the expandable member 420 is disposed around both the body 422 and the elongate member 450. This configuration allows the secondary instrument 455 to be moved straight through the body lumen distal to the stabilization device 404 to reach a desired portion of the body lumen. This secondary instrument can be used in conjunction with a first tool that is inserted through the first instrument, for example, through a working channel of the endoscope 414. The visualization capabilities of the endoscope, the stability and positioning of the endoscope 414 provided by the accessory device(s) as a platform for working with two or more tools, provide a useful endoscopic surgery system.

[0043] 5A-5C show one embodiment of the expandable guide device 501 of the present disclosure, including multiple expandable members 520. The device 501 can be operated in a similar manner as described above for the other embodiments. The expandable members 520 are disposed around the circumference of a body 522 having a lumen 514. Each expandable member 520 includes a delivery member 550 extending proximally along the body 522, the distal end of which extends toward the distal end of the instrument. FIG. 5B shows a cross-sectional view of the expandable guide device of FIG. 5A, including the body 522 and the expandable members 520. In this configuration, the multiple expandable members 520 can be expanded independently, causing the body 522 to move radially or laterally within the body lumen in a direction opposite to the expansion. FIG. 5C shows one example of an expandable guide device 501 disposed around an instrument 510 within a body lumen 500. To move the instrument 510 radially within the body lumen 500 directly towards the nipple 512, the expandable member 520a may be expanded to push against the body lumen 500 while the remaining expandable member 520b is de-expanded / partially expanded. This allows the instrument 510 to be offset radially within the body lumen 500 at any number of radial positions within the body lumen 500 by independently and selectively expanding the members to various degrees of expansion as determined by any position of the instrument within the body lumen. This may also be desired for purposes of establishing a particular angle of entry into the nipple. The members 520 may be partially or fully expanded in various combinations to move the instrument 510 radially in any direction.

[0044] In various embodiments described herein or otherwise within the scope of the present disclosure, the distal end of the instrument may or may not extend beyond the distal end of the expandable guide device. In various embodiments described herein or otherwise within the scope of the present disclosure, a device may include a sensor.

[0045] In various embodiments described herein or otherwise within the scope of the present disclosure, the central axis of the first body can be offset from the central axis of the first expandable member when the first expandable member is in the expanded configuration.

[0046] In various embodiments described herein or otherwise within the scope of the present disclosure, an expandable member may expand to a greater or lesser extent than a different expandable member. In various embodiments described herein or otherwise within the scope of the present disclosure, the expandable guide device may be disposable, hi alternative embodiments, the expandable guide device may be reusable.

[0047] In various embodiments described herein or otherwise within the scope of the present disclosure, a method of performing an endoscopy may include coupling at least one expandable guide device to an instrument. The device may include a first expandable member and a second expandable member. The instrument and at least one expandable guide device are inserted together into a body lumen. The instrument and the instrument may be advanced toward a treatment site. The expandable member may be expanded within the body lumen to contact the patient's body lumen, e.g., duodenum, intestine, etc., and may further expand to some extent. The expandable guide device increases in diameter as the expandable member expands, preventing radial, longitudinal, and / or axial movement of both the instrument and the expandable guide device. The method may include expanding the second expandable member to provide lateral stabilization of the instrument relative to the body lumen. Expanding the expandable member may keep the instrument stable while the instrument is used to examine other areas of the body. This can be accomplished by having the outer diameter of the expandable member contact or expand the body lumen to inhibit or prevent migration of the device, as well as by selective expansion of the expandable member to position the instrument.

[0048] Variations, modifications, and other implementations of the disclosure in addition to the various embodiments described herein will occur to those skilled in the art, and thus the disclosure is to be defined not by the preceding illustrative description, but instead by the following claims.

Claims

1. 1. An expandable guide device, comprising: The guide device comprises a first body having a proximal end, a distal end, an inner surface, an outer surface, and a first body lumen extending through the first body along a longitudinal axis; the guide device comprising a first expandable member disposed about the exterior surface of the first body; the guide device comprising a second body having a proximal end, a distal end, an inner surface, an outer surface, and a second body lumen extending through the second body along a longitudinal axis, the second body lumen configured to slidably receive a first length of an extendable instrument therethrough; the guide device comprising a second expandable member disposed about the second body; the guide device comprising a third body having a proximal end, a distal end, an inner surface, an outer surface, and a third body lumen extending through the third body along a longitudinal axis, the third body disposed within the first body lumen, the third body lumen configured to slidably receive a second length of the instrument extendable therethrough; the guide device comprising a third expandable member disposed about an inner surface of the third body. Expandable guide device.

2. The guide device of claim 1 , wherein the first and second expandable members are made of a flexible material.

3. The guide device of claim 1 or 2, further comprising at least one delivery member in fluid communication with at least one of the first expandable member, the second expandable member, and the third expandable member.

4. The guide apparatus of claim 3 , wherein the at least one delivery member is in fluid communication with each of the first expandable member, the second expandable member, and the third expandable member.

5. The at least one delivery member comprises CO ２ 5. The guide device of claim 3 or 4, in fluid communication with a source of fluid, contrast fluid, or air.

6. The guide device according to any one of claims 1 to 5, wherein the second body is made of a flexible, expandable material.

7. The guide device of any one of claims 1 to 6, wherein the second body lumen of the second body is configured for frictional contact with the instrument.

8. The guide device of any preceding claim, wherein the first expandable member comprises a plurality of chambers.

9. The guide apparatus of claim 8 , wherein each chamber of the plurality of chambers comprises an independent delivery member, and each chamber is independently expandable relative to other chambers of the plurality of chambers.

10. The guide device of any preceding claim, wherein the first expandable member further comprises a sensor.

11. The guide device of any one of claims 1 to 10, wherein a central axis of the first body is offset from a central axis of the first expandable member when the first expandable member is in an expanded configuration.

12. The guide device of any one of claims 1 to 10, wherein the first body further comprises a fourth expandable member disposed between the first body and the third body.

13. The guide apparatus of any one of claims 1 to 11, wherein an inner surface of the first body further comprises a lubricious coating.

14. The guide device of any one of claims 1 to 13, further comprising an elongate member disposed along an exterior surface of the first body, the elongate member comprising a lumen extending therethrough.

15. The guide device of any one of claims 1 to 14, wherein the first expandable member or the second expandable member, or both, are spherical, elliptical, or ellipsoidal in shape.

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