Medical device for fluid transfer and electrosurgical procedures

Abstract

To provide an improved medical device.SOLUTION: A medical device comprises: a flexible elongated member including a longitudinal axis and a distal portion; and a medical terminal part operating body provided at a distal end of the distal portion of the elongated member. The medical terminal part operating body includes: a hub that is configured to be connected to a conductor and defines a first lumen; a tubular distal tool that is made of a conductive material, configured to receive electric energy, defines a second lumen that is in fluid communication with the first lumen of the hub, and is configured to be deflectable in a first direction and in a second direction opposite to the first direction; a distal face (a) wider than the distal tool, and (b) having a width greater than that of the outer surface of the medical terminal part operating body located proximally to the distal face; and a passage that extends through the second lumen of the distal tool to the distal face.SELECTED DRAWING: Figure 13A

Description

[Technical field]

[0001] SUMMARY OF THE DISCLOSURE Embodiments of the present disclosure relate to medical devices, particularly medical devices for fluid transfer and electrosurgery, with moveable distal tools including, for example, deflectable and retractable injection needles. [Background technology]

[0002] Generally, endoscopes are used for a variety of diagnostic and medical procedures. Endoscopes can be used in the diagnosis and treatment of a wide range of diseases and injuries that typically require a physician to access and navigate anatomical lumens within a patient's body and body cavities, such as the abdomen. Once the endoscope is positioned at a desired body portion, a therapeutic instrument can be advanced through the working channel of the endoscope to the desired body portion.

[0003] For example, in certain tissue dissection procedures, a cutting device, such as a needle or surgical blade, can be guided through a working channel of the endoscope to manipulate the endoscope to a desired tissue location. The cutting device can include one or more sharp edges or points configured to cut the target tissue for therapeutic or examination purposes.

[0004] Incidentally, Patent Document 1 is known as a prior art. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International Publication No. 2006 / 048966 Summary of the Invention [Problem to be solved by the invention]

[0006] The sharp edges and points of the resection device can potentially cause undesirable damage to the walls of the working channel and non-target tissue.The medical devices and associated methods disclosed herein are improvements upon existing technology.

[0007] As another example, in certain tissue dissection procedures, a suction device, such as a suction tube, can be directed through a working channel of an endoscope to manipulate the endoscope to a desired tissue location. The suction device can be configured to grasp a particular target tissue for manipulation with other endoscopes, forceps, graspers, snares, probes, scissors, knives, retrievers, lasers, etc.

[0008] A conventional suction device can be positioned relative to the target tissue by movement of the endoscope. In other words, the physician can place the suction device at or near the target tissue by articulating, driving, displacing, pulling, and / or pushing the endoscope. A second operator, such as another physician or physician's assistant, can then control the operation of the suction device once it is at or near the target tissue.

[0009] Adjusting the position of the suction device by moving the endoscope is time consuming, cumbersome, and inaccurate. In addition, moving the endoscope to move the suction device may undesirably move other equipment. Thus, there is a need to simplify and improve the accuracy of the method for adjusting the position of the suction device. The medical device of the present disclosure is an improvement over existing technology. [Means for solving the problem]

[0010] A medical device of the present invention may include a flexible elongate member including a longitudinal axis and a tool connected to the elongate member at a pivot axis, the tool may be configured to pivot relative to the elongate member about the pivot axis toward at least one side of the longitudinal axis, and the tool may be configured to move along the longitudinal axis between an extended position and a retracted position. In one aspect, the medical device comprises a handle assembly, a shaft including an outer sheath extending from the handle assembly and having a passage extending along its entire length, an electrical conductor extending through the passage of the outer sheath, and an inner sheath including a passage extending through the passage of the outer sheath and extending along its entire length, and an end effector assembly extending from a distal end of the shaft, the end effector assembly including a cylindrical distal tool defining a lumen made of an electrically conductive material and configured to receive electrical energy from the electrical conductor, a distal surface wider than the distal tool, a passage extending through the lumen of the distal tool to the distal surface and in fluid communication with the passage of the inner sheath, and an opening opening at the distal surface and in fluid communication with the passage extending through the lumen of the distal tool to the distal surface. In a preferred embodiment, the distal portion is wider than the proximal portion along a direction extending perpendicular to a central axis of the shaft. In a preferred embodiment, the proximal portion is at least partially received within the distal end of the outer sheath. In a preferred embodiment, the opening is circular. In a preferred embodiment, the opening is formed in a curved surface of the distal portion. In a preferred embodiment, the most distal surface of the distal portion is flat. In a preferred embodiment, the distal most surface of the distal portion is perpendicular to a central longitudinal axis of the proximal portion.

[0011] Various embodiments of the present disclosure may include one or more of the following aspects: A U-shaped member and a pivot member carried by and rotatable relative to the U-shaped member may be included. The pivot member may include a lumen. A tool may extend through the lumen. The tool may be movable to the extended position by advancing distally through the lumen. The tool may be movable to the retracted position by retracting proximally through the lumen. The lumen may include a stop configured to prevent the tool from advancing distally beyond a predetermined position. A delivery tube is fluidly connected to the tool. The delivery tube may be configured to contact the stop that prevents the tool from advancing distally beyond a predetermined position. The delivery tube and the tool are integrally formed. A sleeve is configured to cover the tool. The tool may be configured to move between the extended position and the retracted position by relative axial movement between the tool and the sleeve. At least one actuation member is configured to actuate the axial movement of the sleeve. The first and second control members are connected to the pivot member at different points thereof, such that actuation of the first and second control members can pivot the tool to either side of the longitudinal axis. The tool can include a blade. The tool can be configured to move axially relative to the bore to cause an axial cutting action of the blade. The blade can include a serrated blade. The tool can include a double-edged blade. The blade can be electrically conductive. The tool can include a curved blade. The tool can include a curved blade including a concave portion having a sharp edge and a convex portion having a blunt edge.

[0012] According to another embodiment, the medical device can include a flexible elongate member including a longitudinal axis and a tool connected to the elongate member at a pivot axis, the tool can be configured to pivot relative to the elongate member toward at least one side of the longitudinal axis about the pivot axis, the tool can be configured to move between an extended position and a retracted position by pivoting about the pivot axis.

[0013] Various embodiments of the present disclosure may include one or more of the following aspects: A U-shaped member including a slot, and a pivot member carried by and rotatable relative to the U-shaped member. A tool may be operably coupled to the pivot member. In a retracted position, the pivot member rotates and the tool may enter the slot. A first control member is wrapped around the pivot member at a first position of the pivot member. When the first control member is retracted proximally, the tool may be deflected in a first direction. A second control member is wrapped around the pivot member at a second position of the pivot member. When the second control member is retracted proximally, the tool may be deflected in a second direction different from the first direction.

[0014] According to yet another embodiment, the medical device can include a flexible elongate member, a tool, and a pivot member that rotates relative to the elongate member. The pivot member can include a lumen extending therethrough. The tool can be operatively coupled to the pivot member and configured to pivot to either side of the elongate member upon actuation of the pivot member. The tool can be configured to be moved to an extended position by advancing the tool distally through the lumen and to a retracted position by retracting the tool proximally through the lumen.

[0015] Various embodiments of the present disclosure can include the following aspects: The lumen can include a stop configured to prevent the tool from advancing distally beyond a predetermined position. According to an embodiment, the medical device can include a flexible elongate member including a longitudinal axis and a tool connected to the elongate member near a pivot axis, and the tool can be configured for one of aspiration and injection and can be configured to pivot on either side of the longitudinal axis relative to the elongate member about the pivot axis.

[0016] Various embodiments of the present disclosure may include one or more of the following aspects: The tool may be pivoted upon actuation of the positioning mechanism. The positioning mechanism may include a U-shaped member, a pivot member carried by and rotatable relative to the U-shaped member, and a first control member and a second control member operably coupled to the pivot member. The tool may be operably coupled to the pivot member. When the first control member is retracted proximally, the tool may be deflected in a first direction, and when the second control member is retracted proximally, the tool may be deflected in a second direction opposite the first direction. The suction tube may be configured to fluidly connect the tool to a vacuum source. The suction tube may include a flexible distal portion comprising an inner braid reinforced by a polymer sheath. The tool may be a hollow tube having a distal opening. Suction through the tool may cause the hollow tube to grasp tissue. The distal opening may be configured to form a fluid seal between the hollow tube and the tissue. An outer hollow container surrounding the hollow tube defines an opening. The opening may be a side-facing opening. The openings can be distally facing openings. A handle assembly coupled to the flexible elongate member can include a deflection actuator configured to actuate the first and second control members and an aspiration actuator configured to control aspiration of the tool. The aspiration actuator can be configured to selectively allow and block aspiration through the aspiration tube. A distal portion of the elongate member can include a plurality of pivot connections configured to deflect the distal portion.

[0017] According to another embodiment, the medical device can include a flexible elongate member including a longitudinal axis, a tool configured for suction, and a pivot member, where the tool can be operatively coupled to the pivot member and configured to pivot relative to the elongate member toward at least one side of the longitudinal axis upon actuation of the pivot member. The pivot member can include an internal lumen extending to the tool.

[0018] Various embodiments of the present disclosure can include one or more of the following aspects: a suction tube configured to fluidly connect the tool to a vacuum source; and a first control member and a second control member operably coupled to the pivot member. When the first control member is retracted proximally, the tool can be deflected in a first direction, and when the second control member is retracted proximally, the tool can be deflected in a second direction opposite the first direction.

[0019] According to yet another embodiment, the medical device can include a flexible elongate member, a tool configured for suction, a pivoting member operably coupled to the tool, a first control member operably coupled to the pivoting member on a first side of the pivoting member, and a second control member operably coupled to the pivoting member on a second side of the pivoting member opposite the first side, and the tool can be configured to pivot toward both sides of the elongate member upon actuation of the first and second control members.

[0020] Various embodiments of the present disclosure can include one or more of the following aspects: When the first control member is retracted in a proximal direction, the tool can be deflected in a first direction, and when the second control member is retracted in a proximal direction, the tool can be deflected in a second direction opposite the first direction. The suction tube can be configured to fluidly connect the tool to a vacuum source, the suction tube can include a flexible distal portion comprised of an inner braid reinforced by a polymer sheath.

[0021] In this regard, before describing in detail several embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of construction and the arrangement of components set forth in the following description and illustrated in the drawings. The present disclosure is capable of embodiments described, implemented and carried out in various ways, in addition to the present embodiments. Moreover, it is to be understood that the phraseology and terminology employed in the specification and abstract are for the purpose of description and should not be regarded as limiting.

[0022] The accompanying drawings illustrate specific exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. Thus, those skilled in the art will appreciate that the underlying concepts of the present disclosure can be readily utilized as a basis for designing other structures, methods, and systems for carrying out the several purposes of the present disclosure. It is therefore important to understand that the claims should be regarded as including equivalent structures insofar as they do not depart from the spirit and scope of the present disclosure. [Brief description of the drawings]

[0023] [Figure 1] FIG. 1 illustrates an endoscope for use with one or more devices according to one embodiment. [Figure 2A] FIG. 2 is a schematic diagram of an injection needle according to one embodiment. [Figure 2B] FIG. 2B is another schematic diagram of the injection needle of FIG. 2A according to one embodiment. [Figure 2C] FIG. 2B is another schematic diagram of the injection needle of FIG. 2A according to one embodiment. [Figure 3A] 2A-2C in cross-sectional views of the injection needle of FIG. 2A-2C with a protruding structure according to one embodiment. [Figure 3B] 2A-2C in a containment structure according to one embodiment. [Figure 4A] FIG. 2 is a schematic diagram of another injection needle according to an embodiment. [Figure 4B] FIG. 4B is a schematic diagram of the injection needle of FIG. 4A in a partially retracted configuration according to one embodiment. [Figure 4C] FIG. 4B is a schematic diagram of the injection needle of FIG. 4A in a fully retracted configuration according to one embodiment. [Figure 5A] FIG. 2 is a schematic diagram of another injection needle according to an embodiment. [Figure 5B] FIG. 5B is a schematic diagram of the injection needle of FIG. 5A in a partially retracted configuration according to one embodiment. [Figure 5C] FIG. 5B is a schematic diagram of the injection needle of FIG. 5A in a fully retracted configuration according to one embodiment. [Figure 6A] 1 is a schematic diagram of a medical device according to one embodiment. [Figure 6B] 1 is a schematic diagram of another medical device according to an embodiment. [Figure 6C] 1 is a schematic diagram of another medical device according to an embodiment. [Figure 7A] FIG. 1 is a schematic diagram of a suction device according to one embodiment. [Figure 7B] 7B is another schematic diagram of the suction device of FIG. 7A according to one embodiment. [Figure 7C] 7B is another schematic diagram of the suction device of FIG. 7A according to one embodiment. [Figure 8A] FIG. 2 is a schematic diagram of another suction device according to an embodiment. [Figure 8B] 8B is another schematic diagram of the suction device of FIG. 8A according to one embodiment. [Figure 8C] 8B is another schematic diagram of the suction device of FIG. 8A according to one embodiment. [Figure 9A] FIG. 2 is a schematic diagram of another suction device according to an embodiment. [Figure 9B] 9B is another schematic diagram of the suction device of FIG. 9A according to one embodiment. [Figure 9C] 9B is another schematic diagram of the suction device of FIG. 9A according to one embodiment. [Figure 10A] FIG. 2 is a schematic diagram of another suction device according to an embodiment. [Figure 10B] FIG. 10B is another schematic diagram of the suction device of FIG. 10A according to one embodiment. [Figure 10C] FIG. 10B is another schematic diagram of the suction device of FIG. 10A according to one embodiment. [Figure 11A] FIG. 2 is a schematic diagram of another suction device according to an embodiment. [Figure 11B] FIG. 11B is another schematic diagram of the suction device of FIG. 11A according to one embodiment. [Figure 11C] FIG. 11B is another schematic diagram of the suction device of FIG. 11A according to one embodiment. [Figure 12] 1 illustrates a handle assembly of an aspiration apparatus according to one embodiment. [Figure 13A] FIG. 1 illustrates a cup arrangement of a suction apparatus according to an embodiment. [Figure 13B]13A-13C show another cup arrangement of the suction apparatus according to an embodiment. [Figure 13C] FIG. 13 illustrates another cup arrangement of the suction apparatus according to an embodiment. [Figure 13D] 13A-13C show another cup arrangement of the suction apparatus according to an embodiment. [Figure 13E] 1 is another cup arrangement for a suction device according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] Reference will now be made in detail to the exemplary embodiments of the present disclosure described above and illustrated in the accompanying drawings. The terms "proximal" and "distal" can be used to refer to the relative locations of components of an exemplary endoscope. As used herein, "proximal" refers to a location that is closer to the outside of the body or closer to the physician or other user using the endoscope. In contrast, "distal" refers to a location that is farther from the surgeon or other user using the endoscope or closer to the inside of the body.

[0025] FIG. 1 illustrates an endoscope 1 according to one exemplary embodiment. The endoscope 1 may include a flexible outer tube 2 extending between a distal end 3 and a proximal end 4 of the endoscope 1. The endoscope 1 may further include at least one therapeutic instrument port 5 for accommodating a therapeutic device, such as an aspiration device, an injection needle, an electrocautery needle, forceps, or any other suitable device known in the art, in at least one working channel 6 of the endoscope 1. The at least one working channel 6 may extend through the endoscope 1 and terminate at the distal end 3 in an opening 7. Although the opening 7 is illustrated as defined in a distal surface of the outer tube 2, it should be appreciated that one or more openings 7 may be defined in a side surface of the outer tube 2.

[0026] Endoscope 1 may also include a handle 8 at proximal end 4. Handle 8 may include various positioning controls 9 for bending and rotating flexible outer tube 2 to position endoscope 1 and any therapeutic equipment during a medical procedure.

[0027] The present disclosure may relate to endoscopes that may include various types of end effectors or tools at the distal end of the endoscope that require precise positioning within an anatomical lumen. The present disclosure describes embodiments of injection needles, suction devices, and irrigation devices. However, other types of tools may be substituted, including but not limited to devices such as biopsy forceps, graspers, scissors, knives, needle knives, probes, dissectors, scrapers, cauterizing electrodes, suction probes, and the like.

[0028] 2A-2C show an injection needle 200 according to an exemplary disclosed embodiment. The injection needle 200 can extend through at least one working channel 6 of the endoscope 1 and exit the opening 7 to reach the desired treatment location. The injection needle 200 can be configured to, for example, flush a fluid at the treatment site, inject a vasoconstrictor liquid into a reservoir to subside heavy bleeding, inject a sclerosing agent to harden the target tissue and thereby control bleeding aneurysms, inject a suitable fluid to generate air bubbles at the treatment location, inject a fluid into tissue at the treatment location to separate tissue planes, inject a fluid dye such as indigo carmine for visualization, inject a drug, or inject a filler. In certain embodiments, the injection needle 200 can be configured to aspirate fluid and / or tissue.

[0029] As shown in FIG. 2A, the injection needle 200 can include a distal tool 11, a positioning mechanism 212, and a flexible tube 13. The distal tool 11 can be hollow and can include a lumen that is fluidly connected to a delivery tube 14 that extends through the flexible tube 13. In some embodiments, the distal tool 11 can be a hypotube. A flexible stylet can be disposed within the lumen of the distal tool 11 to provide structural strength to the distal tool 11 and block tissue penetration. A suitable fluid can be delivered from a fluid source (not shown) through the delivery tube 14 and expelled from a distal opening of the distal tool 11. The distal tool 11 can be made of any electrically conductive material, such as stainless steel or nickel titanium alloy. All or one or more portions of the distal tool 11 can be made of an electrically conductive material. The distal end of the distal tool 11 can be relatively sharp to penetrate tissue. Alternatively, the distal end of the distal tool 11 can be relatively blunt to penetrate tissue via an electrical current passing through the distal tool 11, as described in more detail below. Being relatively blunt allows the injection needle 10 to be advanced through the at least one working channel 6 of the endoscope 1 without scraping the walls of the channel 6. The proximal end of the distal tool 11 may be operably coupled to a positioning mechanism 212.

[0030] The positioning mechanism 212 can be configured to rotate or deflect the distal tool 11 of the injection needle 200 about a pivot axis 215. In other words, as shown in Figures 2B-2C, the distal tool 11 can be pivoted laterally relative to the longitudinal axis 16 of the flexible tube 13 by actuation of the positioning mechanism 212. The positioning mechanism 212 can include a U-shaped member 17, a pivot member 218, a first control member 219, and a second control member 220. The first and second control members 219, 220 can include any suitable coupling device, such as a wire, a rod, or a hollow tube.

[0031] The U-shaped member 17 can be disposed at the distal end of the flexible tube 13. The proximal portion of the U-shaped member 17 can be disposed above the flexible tube 13 and hollow to provide communication between the flexible tube 13 and the pivot member 218. Alternatively, the proximal portion of the U-shaped member 17 can be disposed below (or in) or in contact with the flexible tube 13.

[0032] The pivot member 218 may be disposed within the U-shaped member 17 and coupled to the U-shaped member 17 via a first pin (or protrusion) 222 and a second pin (or protrusion) 223. The first pin 222 may extend from a first side 224 of the pivot member 218 and rotatably connect the pivot member 218 to a first arm 25 of the U-shaped member 17. The second pin 223 may extend from a second side 226 of the pivot member 218 and rotatably connect the pivot member 218 to a second arm 27 of the U-shaped member 17. Thus, the pivot member 218 may be configured to rotate about the first pin 222 and the second pin 223.

[0033] A distal portion of the first control member 219 can be secured to the pivot member 218 at a first point on the pivot member 218, and a distal portion of the second control member 220 can be secured to the pivot member 218 at a second point different from the first point on the pivot member 218. For example, the first control member 219 and the second control member 220 can be disposed on opposite sides of the pivot member 218. The first and second control members 219, 220 can be secured to the pivot member 218 by any suitable means, such as adhesives, welding, crimping, fasteners, anchors, etc. Additionally, the first and second control members 219, 220 can be generally aligned with one another and disposed on opposite sides of the distal tool 11. As will be described in more detail below, the delivery tube 14 and the distal tool 11 can extend through the pivot member 218 between the first and second members 219, 220.

[0034] A suitable handle assembly (not shown) can be operatively coupled to the first control member 219 and the second control member 220 on the exterior of the endoscope 1 to manipulate the first and second control members 219, 220. Any suitable known handle assembly can be used, such as a spool-type handle or a scissor-like handle. As shown in FIG. 2B, the handle assembly can be actuated to retract the first control member 219 in a proximal direction. That is, pulling the first control member 219 can rotate the pivot member 218 to deflect the distal tool 11 in a first direction. As shown in FIG. 2C, the handle assembly can be actuated to retract (i.e., pull) the second control member 220 in a proximal direction to rotate the pivot member 218 to deflect the distal tool 11 in a second direction opposite the first direction. Thus, the angle between the distal tool 11 and the longitudinal axis 16 can be changed upon actuation of the first and second control members 219, 220. However, it should be appreciated that the injection needle 200 can include any suitable restraining means for adjusting the range of movement of the distal tool 11. For example, the handle assembly can include a suitable stop configured to limit the length of the retractable first control member 219 and / or second control member 220. Alternatively, the mechanism 212 can include a suitable stop to limit the range of movement of the tool 11. Additionally, in certain embodiments, the handle assembly can include a suitable locking mechanism to lock the distal tool 11 in any suitable position. For example, the locking mechanism can secure the distal tool 11 in a deflected position and release the distal tool 11 from the deflected position if desired.

[0035] In other embodiments, one or both of the first control member 219 and the second control member 220 can be designed to be advanced distally to rotate the pivot member 218. Additionally, it should be appreciated that the pivot member 218 can be designed to pivot eccentrically and can take any suitable shape, such as, for example, a circular disk, a sphere, a cylinder, or any other symmetrical or asymmetrical shape (e.g., a cam-like surface).

[0036] As described above, the distal tool 11 can be electrically conductive to operate as an electrosurgical treatment device. For example, the distal tool 11 can coagulate, cauterize, incise, burn, and / or cut target tissue after being energized with an electrical current. Additionally, the distal tool 11 can be configured to perform monopolar or bipolar cauterization. Such electrosurgical treatment with the distal tool 11 is performed when the distal tool 11 is deflected about the pivot axis 215. Additionally, electrosurgical treatment with the distal tool 11 can be performed in conjunction with the fluid delivery features of the injection needle 10. For example, fluid can be injected through the distal tool 11 into the tissue treatment site to separate a particular tissue layer, such as an adenoma, from the underlying tissue. The distal tool 11 can then be electrically activated to cauterize and remove the adenoma.

[0037] In one exemplary embodiment, the first control member 219 and / or the second control member 220 can provide an electrical path from a current source (not shown) to the distal tool 11. The handle assembly can include a suitable connector for connection to, for example, a radio frequency (RF) energy source. Energy can be transferred to the first control member 219 and / or the second control member 220 through the handle assembly. The first control member 219 and / or the second control member 220 and the pivot member 218 can comprise any electrically conductive material, such as stainless steel, nickel titanium alloy, etc. Contact between the distal tool 11 and the pivot member 218 can provide an electrical connection that is electrically transferred through the first control member 219 and / or the second control member 220. Additionally or alternatively, one or more separate electrically conductive wires, cables, sheaths, etc. may be twisted along or adjacent to, formed within, or physically separate from, one or both of the first and second control members 219 and 220 to provide an electrical path to the distal tool 11. The U-shaped member 17 may be made of any electrically conductive material. However, the surface of the U-shaped member 17 may be coated with a suitable insulating material, such as a powder coating or a non-conductive polymer sheath, to minimize charging and effects of stray electrical energy from the U-shaped member 17. Insulating the U-shaped member 17 may prevent electrical energy from causing tissue damage due to accidental contact with the U-shaped member 17. Similarly, the flexible tube 13 may be made of a non-conductive polymer material or may be coated with a non-conductive insulating polymer material.

[0038] It should be appreciated that one or both of the first and second control members 219 and 220 and the pivot member 218 can be covered with a suitable insulating material. For example, one or both of the first and second control members 219 and 220 can be covered with an insulating sheath and the surface of the pivot member 218 can be powder coated with an insulating material. A suitable insulating material can also be used anywhere on the injection needle 200 to prevent undesired electrical paths. The insulating material can include a polymer, a ceramic, or any other suitable non-conductive material.

[0039] Additionally or alternatively, the delivery tube 14 can provide an electrical path from a current source to the distal tool 11. In such a configuration, the delivery tube 14 can include a coil or wire of any suitable conductive material in direct contact with the distal tool 11. A sheath of insulating polymeric material can cover the coil to prevent charging and action of stray electrical energy from the delivery tube 14. In another embodiment, the delivery tube 14 can be a sheath of insulating polymeric material. A conductive member can be attached to the inner wall of the sheath and directly connected to the distal tool 11 to provide an electrical path from the current source to the distal tool 11. Alternatively, a conductive member can be attached to the outside of the sheath and electrically connected to the pivot member 218. In this manner, electrical energy can be transferred from the pivot member 218 to the distal tool 11. It should be appreciated that the conductive member can be covered with a suitable insulating material to prevent charging and action of stray electrical energy.

[0040] Thus, the injection needle 200 allows the distal tool 11 to be adjusted independently of the endoscope 1. That is, the position of the distal tool 11 can be changed by manipulating the positioning mechanism 212 without the need to articulate, drive, displace, pull, and / or push the endoscope 1. Thus, more precise control of the position of the distal tool 11 can be provided to the physician. Also, the physician can manipulate and control the injection needle 200 without the assistance of a second operator, such as another physician or physician's assistant. The physician can directly and simultaneously control the position and actuation (i.e., fluid delivery and electrocautery) of the injection needle 200. Furthermore, when using the injection needle 200 with an endoscope that houses multiple tools, the position of the injection needle 200 can be controlled independently without moving other tools, since the entire endoscope does not need to be manipulated to position the injection needle 200.

[0041] FIG. 3A is a cross-sectional view of an injection needle 200 with a protruding configuration according to one exemplary embodiment. As shown in FIG. 3A, the pivot member 218 can include an open lumen 300 extending from the proximal end to the distal end of the pivot member 218. At least a portion of the distal tool 11 and the delivery tube 14 can extend through the lumen 300. As described above, the delivery tube 14 can be in fluid communication with the tool 11. Thus, the delivery tube 14 can be connected to the tool 11 by any suitable means, such as adhesives, welding, friction fit, crimping, clamping, etc. Alternatively, the delivery tube 14 and the tool 11 can be integrally formed and the tool 11 can be a rigid protruding portion of the delivery tube 14, such as a tapered portion at the distal end of the delivery tube 14. The delivery tube 14 can be formed of any suitable flexible material that accommodates bending and deflection of the delivery tube 14 upon rotation of the pivot member 218, yet is rigid enough to provide axial translation of the distal tool 11 and the delivery tube 14 through the lumen 300. In certain embodiments, for example, the delivery tube 14 can include flexible sections structurally designed to enhance flexibility, such as bellows. The delivery tube 14 can be made of one or more of a metal, plastic, polymer, elastomer, and can be formed of multiple materials with varying flexibility and stiffness along the delivery tube 14. In certain embodiments, the distal portion of the delivery tube 14 can be more flexible than the proximal portion of the delivery tube 14 to accommodate bending. For example, the distal portion of the delivery tube 14 can be formed of a metal spring or coil covered by a flexible material, such as a polymer sheath, and the proximal portion of the delivery tube 14 can be formed of a rigid polymer tube.

[0042] The distal tool 11 can be disposed in a protruding position as shown in FIG. 3A. That is, the distal tool 11 can be advanced distally and extended out of the lumen 300 at the distal end of the pivot member 218. In the protruding position, at least a portion of the delivery tube 14 and the tool 11 can extend through the lumen 300. More specifically, the lumen 300 can include a first portion 301 having a first diameter and a second portion 302 having a second diameter smaller than the first diameter of the first portion 301. The first diameter of the first portion 301 can be sized to allow axial movement of the distal tool 11 and the delivery tube 14 through the lumen. The widths of both the distal tool 11 and the delivery tube 14 can be smaller than the first diameter such that the distal tool 11 and the delivery tube 14 can move freely within the first portion 301. The second diameter of the second portion 302 can be sized to permit axial movement of the distal tool 11 through the lumen but not access of the delivery tube 14. In other words, the juncture of the first portion 301 and the second portion 302 forms a stop 303 defined by the wall of the lumen 300 to prevent distal advancement of the delivery tube 14 (and thus the distal tool 11) beyond a predetermined position. The width of the distal tool 11 can be smaller than the second diameter of the second portion 302 so that the distal tool 11 can move freely within the second portion 302, and the width of the delivery tube 14 can be larger than the second diameter of the second portion 302 so that the delivery tube 14 is restricted from contacting the stop 303 and entering the second portion 302. Alternatively, in certain embodiments, the distal tool 11 and the delivery tube 14 can have approximately the same diameter. A suitable shoulder structure (not shown) may be disposed between the distal tool 11 and the delivery tube 14 and may have a diameter larger than the diameters of the distal tool 11 and the delivery tube 14 and may be large enough to contact the stop 303.

[0043] FIG. 3B is a cross-sectional view of the injection needle 200 in a retracted configuration according to one exemplary embodiment. As shown in FIG. 3B, the distal tool 11 can be placed in a retracted position by pulling the delivery tube 14 proximally until the distal tool 11 does not extend out of the lumen 300. The handle assembly of the injection needle 200 can also be operatively coupled to the delivery tube 14 to manipulate the axial movement of the delivery tube 14. Thus, the delivery tube 14 can be actuated to move distally (i.e., push) to place the distal tool 11 in an extended position, as shown in FIG. 3A, or to retract proximally (i.e., pull) to place the distal tool 11 in a retracted position. It should be appreciated that the delivery tube 14 can be actuated to place the distal tool 11 in any position between the retracted and extended positions. For example, the delivery tube 14 can be advanced slightly distally to place the distal tool 11 in a partially extended position outside the pivot member 218. It should further be appreciated that either or both of the delivery tube 14 and the handle assembly can include any suitable stop or boundary configured to prevent proximal retraction of the delivery tube 14 and distal tool 11 beyond a predetermined position. Additionally, in certain embodiments, the handle assembly can include any suitable locking mechanism configured to lock the distal tool 11 at any axial position between, including the retracted and extended positions.

[0044] It should be appreciated that the distal tool 11 may be comprised of a shape memory material (e.g., Nitinol) or a superelastic material such that when extended from the lumen 300, it may be biased into a curved configuration or any other suitable shape, or may become approximately linear when retracted into the lumen 300.

[0045] Figures 4A-4C show another embodiment of an injection needle 400. The injection needle 400 is generally similar to the injection needle 200 of Figures 2A-3B and may include a flexible tube 13, a distal tool 11 fluidly connected to a delivery tube 14, a U-shaped member 170, a pivot member 218, a first control member 219, and a second control member 220. However, as shown in Figures 4A-4C, the injection needle 400 may be configured for lateral folding storage of the distal tool 11.

[0046] To laterally fold and store the distal tool 11, the first control member 219 and the second control member 220 can each be secured to the pivot member 218 by any suitable means and wrapped around the entire circumference of the pivot member 218. Additionally, the first and second control members 219, 220 can be located at different positions relative to the distal tool 11. For example, the first control member 219 can be secured to a first position on the pivot member 218 adjacent to a first arm 127 of the U-shaped member 170, and the second control member 220 can be secured to a second position on the pivot member 218 adjacent to a second arm (not shown) of the U-shaped member 170 that is different from the first position. Thus, such a configuration of the first control member 219 and the second control member 220 allows the pivot member 218, and thus the distal tool 11, to rotate at least 180 degrees in both a first direction and a second direction relative to the longitudinal axis 16. More simply stated, the distal tool 11 can be deflected from a first position generally aligned with the longitudinal axis 16 and pointing in a distal direction (FIG. 4A) to a second position generally aligned with the longitudinal axis 16 and pointing in a proximal direction (FIG. 4C). In other embodiments, one or both of the first control member 219 and the second control member 220 can be designed to be advanced distally to rotate the pivot member 218.

[0047] Additionally, the U-shaped member 170 may include an internal cavity or slot 130 to accommodate lateral folding storage of the distal tool 11. The distal tool 11 may be rotated toward the slot 130 and into the slot 130 to be received within the U-shaped member 170. Although not shown, it should be appreciated that as the distal tool 11 enters the slot 130 and the U-shaped member 170, at least a portion of the delivery tube 14 may exit the U-shaped member 170 between the first arm 127 and the second arm to form a space within the U-shaped member 170 for the distal tool 11. It should be appreciated that in certain embodiments, another slot may be disposed in the opposing slot 130 of the U-shaped member 170 to accommodate lateral folding storage of the distal tool 11 in a direction opposite to that shown in FIGS. 4A-4C.

[0048] Similar to the embodiment of FIGS. 2A-3B, the injection needle 400 can include a suitable handle assembly configured to effect actuation of the first control member 219 and the second control member 220. Additionally, the injection needle 400 can include any suitable restraining means for adjusting the range of travel of the tool 11. For example, the handle assembly can include a suitable stop configured to limit the length of the retractable first control member 219 and / or second control member 220. The handle assembly can include any suitable locking mechanism configured to lock the position of the distal tool 11 at any position between the extended position shown in FIG. 4A, the laterally folded retracted position shown in FIG. 4C, the partially extended extended position shown in FIG. 4B, and the like. Additionally, it should be appreciated that the injection needle 400 can include axial retraction and extension features of the distal tool 11 and flexible tube 13 as described above with reference to FIGS. 3A-3B. Additionally, the injection needle 400 can include similar electrical connections and insulation as described above with reference to FIGS. 2A-2C for electrically energizing the distal tool 11.

[0049] Figures 5A-5C show another injection needle 500. The injection needle 500 may be generally similar to the injection needle 200 of Figures 2A-3B and may include a flexible tube 13, a distal tool 11 fluidly connected to a delivery tube 14, a U-shaped member 17, a pivot member 218, a first control member 219, and a second control member 220. As shown in Figures 5A-5C, the injection needle 500 may further include a retractable sleeve 501 configured to selectively accommodate and expose the distal tool 11.

[0050] The retractable sleeve 501 includes a tube 502 made of any suitable material, such as a polymeric material, and may be reinforced with any suitable material and / or structure, such as a braid or coil. The tube 502 may include a channel configured to accommodate the distal tool 11 and at least a portion of the positioning mechanism 212. For example, in the fully extended configuration shown in FIG. 5A, the tube 502 may completely cover the distal tool 11 and the pivot member 218, and partially cover the U-shaped member 17. However, it should be appreciated that the tube 502 may be of any suitable size to accommodate any other elements of the injection needle 500. For example, the tube 502 may have a suitable length to cover a portion of the flexible tube 13 and completely cover the distal tool 11, the pivot member 218, and the U-shaped member 17.

[0051] The retractable sleeve 501 may also include one or more actuating members 503 operably coupled to the tube 502 by any suitable mounting or fastening means. The one or more actuating members 503 may include any suitable coupling device, such as a wire, a rod, or a hollow tube. The one or more actuating members 503 may be configured to effect axial movement of the tube 502 relative to the longitudinal axis 16. For example, as shown in FIG. 5A, the retractable sleeve 501 may be placed in a protruding position to accommodate the distal tool 11 and a portion of the positioning mechanism 212 by pushing the one or more actuating members 503 to advance the tube 502 distally past the positioning mechanism 212 and the distal tool 11. As shown in FIG. 5B, the retractable sleeve 501 may be placed in a partially retracted position to expose the distal tool 11 and partially accommodate the positioning mechanism 212 by pulling the one or more actuating members 503 to retract the tube 502 proximally to expose the distal tool 11. In the partially retracted position, the distal tool 11 can be exposed to provide appropriate treatment to the target tissue. However, the positioning mechanism 212 can be contained within and constrained by the tube 502 to limit full deflection of the distal tool 11. As shown in FIG. 5C, the retractable sleeve 501 can be placed in a fully retracted position exposing both the distal tool 11 and the positioning mechanism 212 by further retracting the one or more actuating members 503 to retract the tube 502. In the fully retracted position, the distal tool 11 can be exposed to provide appropriate treatment to the target tissue, and the positioning mechanism 212 can fully deflect the distal tool 11 relative to the longitudinal axis 16. It should be appreciated that the one or more actuating members 503 can be external to the flexible tube 13 for all or a portion of the flexible tube 13. For example, the one or more actuating members 503 can enter a channel of the tube 13 near the distal end of the tube 13 and extend proximally.

[0052] Similar to the embodiment of Figures 2A-4C, the injection needle 500 may include a suitable handle assembly for actuating the first control member 219 and the second control member 220. Additionally, the injection needle 500 may include any suitable restraining means for regulating the axial movement of the retractable sleeve 501. For example, a suitable stop may be disposed within the positioning mechanism 212. The handle assembly may also include a suitable stop configured to limit the length that the one or more actuating members 503 may be retracted proximally and advanced distally. The handle assembly may also include any suitable locking mechanism configured to lock the position of the retractable sleeve 501. For example, the locking mechanism may secure the tube 502 at any position between the fully extended position shown in Figure 5A, the fully retracted position shown in Figure 5C, and the partially retracted position shown in Figure 5B. Additionally, it should be appreciated that the injection needle 500 may include an axial retraction and extension mechanism for the distal tool 11 as described above with reference to Figures 3A-3B. Additionally, the injection needle 500 may include electrical connections and insulation as described above with reference to FIGS. 2A-2C for electrically energizing the distal tool 11.

[0053] Thus, by retracting the distal tool 11 as shown in Figures 3A-4C and covering the distal tool 11 with a retractable sleeve 501 as shown in Figures 3A-5C, the injection needle 200, 400, 500 can be delivered through at least one working channel 6 of the endoscope 1 and prevented from scraping the walls of the channel 6 of the distal tool 11, thereby minimizing damage to both the distal tool 11 and the endoscope 1. Retracting and covering the distal tool 11 can also prevent harmful damage to tissue as the injection needle 200, 400, 500 is delivered to and / or removed from the body anatomy.

[0054] It should be appreciated that the protrusible and retractable features of the distal tool 11 shown in Figures 3A-4C and the retractable sleeve 501 shown in Figures 5A-5C may be employed in any other suitable medical device having a positioning mechanism configured to deflect a distal tool, such as the medical device disclosed in U.S. Provisional Application No. 61 / 553,301, the entire contents of which are incorporated herein by reference.

[0055] As mentioned above, the distal tool 11 of Figures 2A-5C can include a conductive tube or needle, however, it should be appreciated that the distal tool of the present disclosure can include any other suitable treatment for a medical procedure. For example, the distal tool can include a cutting mechanism as shown in Figures 6A-6C.

[0056] FIG. 6A illustrates a medical device 600 according to an exemplary embodiment. Similar to the injection needle 200 of FIGS. 2A-2C, the medical device 600 can include a flexible tube 13, a positioning mechanism 212 including a U-shaped member 17, a pivoting member 218, a first control member 219, and a second control member 220. The medical device 600 can also include a distal tool 601 operably coupled to the positioning mechanism 212. As shown in FIG. 6A, the distal tool 601 can include a double-edged blade configured to cut and incise tissue. More specifically, the pivoting member 218 can be rotated to deflect the distal tool 601 by retracting the first control member 219 or the second control member 220. Deflecting the distal tool 601 cuts the target tissue in a first direction and a second direction relative to the longitudinal axis 16. Such a deflection-based cutting action provides a faster and easier method of incising tissue.

[0057] FIG. 6B illustrates another medical device 700 according to an exemplary embodiment. The medical device 700 can be similar to the medical device 600 of FIG. 6A. However, as shown in FIG. 6B, the distal tool 701 can be a curved blade and can include a concave portion 702 having a sharp edge configured to cut tissue, and a convex portion 703 having a blunt edge configured to prevent tissue cutting. Such a structure provides tissue cutting in only one direction. In other words, when the distal tool 11 is deflected by the actuation of the first and second control members 219, 220, the distal tool 701 can only cut tissue facing the concave portion 702. Thus, when the distal tool 701 is deflected towards the tissue facing the concave portion 702, the tissue can be cut, but when the distal tool 701 is deflected in the opposite direction, the tissue including the convex portion 703 is not cut or incised due to the blunt edge. Thus, the distal tool 701 provides a safer and more precise device for incising tissue. However, it should be appreciated that both the recessed portions 702 and the protruding portions 703 may include sharp edges that cut tissue.

[0058] FIG. 6C illustrates another medical device 800 according to an example embodiment. The medical device 800 may be similar to the medical devices 600, 700 of FIGS. 6A-6B. However, as shown in FIG. 6C, the distal tool 801 may be a saw blade including a serrated edge 802 and configured to translate axially relative to the longitudinal axis 16 to perform a sawing action to cut and incise tissue. Such a sawing action may facilitate cutting of relatively tough and thick tissue. The distal tool 801 may be deflected on opposite sides of the longitudinal axis 16 by actuation of the first and second control members 219, 220 as shown in FIGS. 6A-6B.

[0059] The control element 803 may be coupled to the distal tool 801 and extend through a lumen 300 (not shown in FIG. 6C ) defined in the pivot member 218. To translate the distal tool 801 axially (indicated by the double-headed arrow), the control element 803 may be advanced distally or retracted proximally through the lumen 300 of the pivot member 218 and the channel of the flexible tube 13. The control element 803 may be any suitable coupling device configured to translate the distal tool 801 axially, such as a wire, rod, or hollow tube. The control element 803 may also be flexible to accommodate bending and deflection of the control element 803 upon rotation of the pivot member 218.

[0060] Further, the medical device 600, 700, 800 may include an extendable and retractable feature as shown in Figures 3A-3B, an extendable and lateral folding retractable feature as shown in Figures 4A-4C, and / or a retractable sleeve 501 as shown in Figures 5A-5C, i.e., the distal tool 601, 701, 801 may extend and retract relative to the pivot member 218 in the same manner as the distal tool 11 of Figures 3A-3B, may extend and retract into a slot in the U-shaped member 17 upon rotation of the pivot member 218 in the same manner as the distal tool 11 of Figures 4A-4C, and / or may be exposed from and housed within the retractable sleeve 501 upon axial movement of the retractable sleeve 501 in the same manner as the distal tool 11 of Figures 5A-5C.

[0061] Similar to the injection needle 200 of FIGS. 2A-5C, a suitable handle assembly (not shown) can be operably coupled to the first control member 219 and the second control member 220 of the medical device 600, 700, 800. Additionally, the handle assembly can include a suitable locking mechanism for locking the distal tool 601, 701, 801 in any suitable position. For example, the locking mechanism can secure the distal tool 601, 701, 801 in a deflected position and release the distal tool 601, 701, 801 from the deflected position as desired. It should be appreciated that the medical device 800 can include any suitable restraining means for adjusting the axial translation of the distal tool 801. For example, the handle assembly can include a suitable stop configured to limit the length of the control element 803 that can be extended and retracted. Additionally or alternatively, a portion of the control element 803 can have a width that is limited by the stop 303 of the lumen 300, as described with reference to FIGS. 3A-3B.

[0062] Although not shown in Figures 6A-6B, it should be appreciated that the delivery tube 14 can be fluidly connected to the distal tool 601 and the distal tool 701 as disclosed in Figures 2A-2C. In such a configuration, the distal tool 601 and the distal tool 701 can be hollow and include openings (not shown) along desired locations of the distal tool 601 and the distal tool 701, such as at their tips. Thus, a suitable fluid can be emitted from a fluid source (not shown), through the delivery tube 14, and out of the openings in the distal tool 601 and the distal tool 701.

[0063] The distal tool 601, 701, 801 may comprise any electrically conductive material, such as stainless steel or nickel titanium alloy. Also, similar to the embodiment of Figures 2A-2C, one or both of the first control member 219 and the second control member 220 may provide an electrical path from a current source (not shown) to the distal tool 601, 701, 801. Additionally, one or more separate electrically conductive wires, cables, sheaths, etc. may be twisted along or adjacent to one or both of the first control member 219 and the second control member 220, formed within one or both of the first control member 219 and the second control member 220, or may be physically separate from one or both of the first control member 219 and the second control member 220 to provide an electrical path to the distal tool 11. Additionally or alternatively, the delivery tube 14 can provide an electrical path from a current source to the distal tools 601 and 701 as shown in the embodiment of Figures 2A-2C, and the control element 803 can provide an electrical path from a current source to the distal tool 801, as can the delivery tube 14. Thus, the distal tools 601, 701, 801 can coagulate, cauterize, incise, burn, and / or cut target tissue after being energized with an electrical current. Additionally, the distal tool 11 can be configured to perform monopolar or bipolar cauterization.

[0064] 6B, the protrusions 703 of the distal tool 701 can be coated with a suitable insulating material. For example, an insulating sheath can cover the protrusions 703, or the protrusions 703 can be powder coated with an insulating material. Thus, tissue contacting the protrusions 703 of the distal tool 701 can be protected from cauterization and damage when the distal tool 701 is electrically energized.

[0065] It should be appreciated that the medical device 600, 700, 800 can include any other suitable positioning mechanism configured to deflect the distal tool 601, 701, 801. For example, the medical device 600, 700, 800 can include any of the positioning mechanisms disclosed in U.S. Provisional Application No. 61 / 553,301.

[0066] In certain embodiments, the distal tool can act as a guide for other endoscopic tools to be inserted into the body anatomy. For example, an electrocautery loop can be delivered through an insertion tube that is coupled to the distal tool. The electrocautery loop can then exit the distal tool and reach the target tissue. By activating a positioning mechanism, the distal tool, and thus the electrocautery loop, can be deflected to a desired location. Any other device can be delivered through the distal tool, including, for example, a snare, basket, brush, needle, forceps, grasper, dissection needle, etc. Additionally, the device delivered through the distal tool can include its own independent steering mechanism.

[0067] It should further be appreciated that any of the injection needles 200, 400, 500, 600, 700, 800 may include an imaging system for visualizing the body anatomy. The imaging system may include any suitable system for capturing images within the body anatomy, such as an electronic camera including optical fibers and / or an illumination unit. Thus, the injection needles 200, 400, 500, 600, 700, 800 may then be used without the endoscope 1 for visualization. Nevertheless, employing the injection needles 200, 400, 500, 600, 700, 800 with an imaging system that includes the endoscope 1 may provide visualization of multiple regions, including one region from the endoscope 1 and another region from the injection needles 200, 400, 500, 600, 700, 800.

[0068] It should be appreciated that in any of the above embodiments, the distal tool 11 may be sharp or blunt and may have any suitable cross-sectional shape, such as an elliptical, rectangular, triangular, or circular shape. Additionally, in certain embodiments, the positioning mechanism 212 may include a separate control member configured to rotate the pivot member 218 upon actuation. The positioning mechanism 212 may also include a suitable biasing member (not shown), such as a spring, that biases the pivot member 218 into a desired orientation. For example, the biasing member may bias the pivot member 218 such that the distal tool 11 is offset from the longitudinal axis 16.

[0069] 7A-7C illustrate a suction device 900 according to one exemplary disclosed embodiment. The suction device 900 can extend through at least one working channel 6 of the endoscope 1 and exit the opening 7 to a desired treatment location. The suction device 900 can be configured to provide suction to grasp and / or retract tissue and / or remove debris and fluids.

[0070] As shown in FIG. 7A, the suction device 900 can include a distal tool 911, a positioning mechanism 912, and a flexible tube 913. The distal tool 911 can be hollow and can include an internal lumen fluidly coupled to a suction tube 914 extending through the flexible tube 913. In some embodiments, the distal tool 911 can be a hypotube. A vacuum can be applied from a vacuum source (not shown) through the suction tube 914 and through a distal opening of the distal tool 911. The distal tool 911 can be formed of any suitable material configured to assist in suction, such as stainless steel, nickel titanium alloy, polymeric materials, plastics, combinations of these materials, and the like. The distal end of the distal tool 911 can be relatively blunt and configured to form a fluid-tight seal against the target tissue upon application of vacuum. Furthermore, being relatively blunt allows the suction device 900 to be advanced through at least one working channel 6 of the endoscope 1 without scraping or damaging the walls of the channel. The proximal end of the distal tool 911 can be operably coupled to the positioning mechanism 912.

[0071] The positioning mechanism 912 can be configured to rotate or deflect the distal tool 911 of the suction device 900 about a pivot axis 915. Thus, the distal tool 911 can be connected to the flexible tube 913 proximate the pivot axis 915. In other words, as shown in FIGS. 7B-7C, the distal tool 911 can be pivoted laterally relative to a longitudinal axis 916 of the flexible tube 913 by actuation of the positioning mechanism 912. The positioning mechanism 912 can include a U-shaped member 917, a pivot member 918, and a control member 919. The control member 919 can include any suitable coupling device, such as a wire, a rod, a filament, or a hollow tube.

[0072] The U-shaped member 917 can be disposed at a distal end of the flexible tube 913. The proximal portion of the U-shaped member 917 can be disposed above the flexible tube 913 and can be hollow to provide communication between the flexible tube 913 and the pivot member 918. Alternatively, the proximal portion of the U-shaped member 917 can be disposed below (or in) the flexible tube 913 or can be in contact with the flexible tube 913.

[0073] In some embodiments, the pivot member 918 can be disposed within the U-shaped member 917 and coupled to the U-shaped member 917 via a first pin (or protrusion) 922 and a second pin (or protrusion) 923. The first pin 922 can extend from a first side 924 of the pivot member 918 and rotatably connect the pivot member 918 to a first arm 925 of the U-shaped member 917. The second pin 923 can extend from a second side 926 of the pivot member 918 and rotatably connect the pivot member 918 to a second arm 927 of the U-shaped member 917. Thus, the pivot member 918 can be configured to rotate about the first pin 922 and the second pin 923. In certain embodiments, the pivot member 918 can be coupled to the U-shaped member 917 via a suitable hinge (or current hinge) that provides for deflection of the pivot member 918 relative to the U-shaped member 917. The pivot member 918 can include a lumen extending to the distal tool 911. The lumen can be fluidly connected to the distal tool 911 such that suction or infusion can be provided to the distal tool 911. In one example, the suction tube 914 can extend partially through the lumen of the pivot member 918 and be fluidly connected to the distal tool 911. In certain embodiments, the suction tube 914 can extend through the lumen and be directly connected to the distal tool 911 by any suitable means such as adhesive, welding, friction fit, crimping, etc. Alternatively, the suction tube 914 and the distal tool 911 can be integrally formed and the distal tool 911 can be a rigid protrusion of the suction tube 914. In another example, the suction tube 914 can terminate on an outer surface of the pivot member 918 and be fluidly connected to a proximal opening of the lumen. Thus, a vacuum force can be transferred to the suction tube 914 through the distal opening of the distal tool 911 and the lumen of the pivot member 918. The suction tube 914 may be formed of any suitable flexible material that accommodates bending and deflection of the suction tube 914 upon rotation of the pivot member 918. The suction tube 914 may be made of one or more of a metal, plastic, polymer, elastomer, and may be formed of a number of materials that vary in flexibility and stiffness along the suction tube 914. In certain embodiments, a distal portion of the suction tube 914 may be more flexible than a proximal portion of the suction tube 914 to accommodate bending.For example, the distal portion of the suction tube 914 may be formed of a spring or coil, such as a metal spring or coil covered with a flexible material, such as a polymer sheath, and the proximal portion of the suction tube 914 may be formed of a rigid polymer tube. It should be appreciated that the stiffness / flexibility of the suction tube 914 may be varied, for example, by varying the wall pressure of the suction tube 914, varying the stiffness of the material of the suction tube 914, forming the suction tube 914 from a harder and more flexible material along the suction tube 914, forming holes and / or notches in the wall of the suction tube 914.

[0074] The pivot member 918 can also include a proximally extending coupling element in the form of an extension 928. The extension 928 and the control member 919 can be located near the first side 924 or the second side 926 of the pivot member 918 to provide a generally central access to the distal tool 911 of the suction tube 914. The extension 928 can be, for example, a fin-like projection that is connected to the control member 919 at a coupling point 929. The extension 928 can have any suitable length. The coupling point 929 between the control member 919 and the extension 928 can have any suitable pivot structure having any suitable shape and can be located at any suitable location on the extension 928. For example, the control member 919 can extend through a hole in a side of the extension 928 and be secured to the extension 928 by clamping. The hole can have a diameter larger than the diameter of the member 919 to allow the member 919 to properly rotate within the hole. Thus, when control member 919 is pushed out (FIG. 7B) or pulled in (FIG. 7C), control member 919 and coupling member 928 can pivot relative to one another at attachment point 929.

[0075] As described below, a suitable handle assembly can be operatively coupled to a control member 919 on the exterior of the endoscope 1 to steer the control member 919. The control member 919 can be actuated to advance in a distal direction as shown in FIG. 7B. In other words, the control member 919 can be pivoted relative to the push-out extension 928 to rotate the pivot member 918 and deflect the distal tool 911 in a first direction. As shown in FIG. 7C, the control member 919 can be rotated proximally (i.e., pulled) and pivoted relative to the extension 928 to rotate the pivot member 918 in the opposite direction and deflect the distal tool 911 in a second direction opposite the first direction. Thus, the angle between the distal tool 911 and the longitudinal axis 916 can be changed upon actuation of the control member 919. Deflection of the distal tool 911 can be limited by any number of suitable stop structures, as desired. For example, one or more of the flexible tube 913, the U-shaped member 917, the control member 919, the extension 928, and the connection point 929 can be dimensioned such that the control member 919 contacts the inner wall of the U-shaped member 917 or the flexible tube 913 when the distal tool 911 reaches a predetermined angle relative to the longitudinal axis 916.

[0076] The control member 919 may also include a bend 930. As shown in FIG. 7B, as the control member 919 advances distally, the bend 930 extends the outer U-shaped member 917 at an angle offset from the longitudinal axis 916 while the portion of the control member 919 proximate the bend 930 moves toward the inner wall of the flexible tube 913. The control member 919 may pivot relative to the extension 928 such that the bend 930 extends from the U-shaped member 917 at an angle such that the extension 928 is deflected more out of the slot defined between the first and second arms 925, 927 of the U-shaped member 917. Thus, the further angular rotation of the pivot member 918 may further increase the range of motion of the distal tool 911 as the control member 919 advances distally.

[0077] The bend 930 can limit the range of movement of the distal tool 911 when the control member 919 is retracted proximally. As shown in FIG. 7C, when the control member 919 is retracted proximally, the control member 919 can pivot relative to the extension 928 and the bend 930 can retract into the U-shaped member 917. However, the bend 930 can limit the extension 928 from moving out of the slot defined between the first and second arms 925, 927. Thus, the reduced angular rotation of the pivot member 918 can reduce the range of movement of the distal tool 911 when the control member 919 is retracted proximally compared to when the control member 919 is advanced distally.

[0078] Thus, the greater the bend in the control member 919 (i.e., the smaller the bend angle between the bend 930 and the remainder of the control member 919), the greater the range of movement of the distal tool 911 when the control member 919 advances distally, but the smaller the range of movement of the distal tool 911 when the control member 919 retracts proximally. Such a structure may provide certain advantages. For example, it may be beneficial to increase the range of movement of the distal tool 911 in one direction to reach target tissue for aspiration, while at the same time limiting the range of movement in the opposite direction to prevent the distal tool 911 from contacting and damaging healthy tissue. Additionally, configuring the extension 928 with the bend 930 provides a folded, compact structure for the positioning mechanism 912. That is, by housing a substantial portion of the control member 919 and the extension 928 within the U-shaped member 917, for example, unwanted tissue snagging may be prevented. It should be appreciated that increasing the length of the bend 930 increases the range of movement of the distal tool 911 when the control member 919 advances distally and decreases the range of movement of the distal tool 911 when the control member 919 retracts proximally. Additionally, varying the flexibility of the bend 930 can affect the range of movement of the distal tool 911. For example, forming the bend 930 from a more flexible material than the remainder of the control member 919 allows the bend 930 to bend or deflect as the control member 919 retracts proximally and advances distally. Thus, increasing the flexibility of the bend 930 can increase the range of movement of the distal tool 911 when the control member 919 retracts proximally and advances distally.

[0079] 8A-8C show another embodiment of the suction device 1000. Similar to the embodiment of FIGS. 7A-7C, the suction device 1000 can include a flexible tube 913 and a distal tool 911 fluidly connected to the suction tube 914. The suction device 1000 can also include a positioning mechanism 1012 configured to deflect the distal tool 911 about a pivot axis 1015. Thus, the distal tool 911 can be connected to the flexible tube 913 proximate the pivot axis 1015. Similar to the embodiment of FIGS. 7A-7C, the positioning mechanism 1012 can include a U-shaped member 917. Additionally, the positioning mechanism 1012 can include a pivot member 1018, a first control member 1019, and a second control member 1190. Similar to the control member 919, the first and second control members 1019, 1190 can include any suitable coupling device, such as a wire, a rod, a filament, or a hollow tube.

[0080] The pivot member 1018 may be disposed within the U-shaped member 917 and coupled to the U-shaped member 917 via a first pin (or protrusion) 1022 and a second pin (or protrusion) 1023. The first pin 1022 may extend from a first side 1024 of the pivot member 1018 and rotatably connect the pivot member 1018 to a first arm 925 of the U-shaped member 917. The second pin 1023 may extend from a second side 1026 of the pivot member 1018 and rotatably connect the pivot member 1018 to a second arm 927 of the U-shaped member 917. Thus, the pivot member 1018 may be configured to rotate about the first pin 1022 and the second pin 1023. Similar to the embodiment of FIGS. 7A-7C, the suction tube 914 may be fluidly connected to the distal tool 911.

[0081] The pivot member 1018 may further include a first coupling element in the form of an extension 1028 proximate the first pin 1022 and a second coupling element in the form of an extension 1080 proximate the second pin 1023. The suction tube 914 may be fluidly connected to the distal tool 911 between the extensions 1028 and 1080. The extensions 1028, 1080 may be, for example, fin-like protrusions. Additionally, the extensions 1028, 1080 may be symmetrically or asymmetrically positioned about the pivot member 1018 and symmetrically or asymmetrically positioned on the pivot member 1018 along the pivot axis 1015. Additionally, the extensions 1028, 1080 may include any suitable length. The extension 1028 may be coupled to the first control member 1019 at a first coupling point 1029 and to the second control member 1190 at a second coupling point 1090. The first and second attachment points 1029, 1090 may be any suitable pivot structure having any suitable shape and may be located at any suitable location on the extensions 1028, 1080. Thus, when the first control member 1019 is pushed out (FIG. 8B) or pulled in (FIG. 8C), the first control member 1019 and the extension 1028 may pivot relative to one another at the first attachment point 1029. Additionally, when the second control member 1190 is pushed out (FIG. 8C) or pulled in (FIG. 8B), the second control member 1190 and the second control element 1080 may pivot relative to one another at the second attachment point 1090.

[0082] A suitable handle assembly (not shown) may be connected to the first control member 1019 and the second control member 1190 to manipulate the first and second control members 1019, 1190. The handle may be associated with the endoscope 1, for example. As shown in FIG. 8B, the handle assembly may be actuated to advance the first control member 1019 in a distal direction while retracting the second control member 1190 in a proximal direction. That is, by pushing the first control member 1019 and pulling the second control member 1190, the first and second control members 1019, 1190 may be pivoted relative to the extensions 1028, 1080 to rotate the pivot member 1018 and deflect the distal tool 911 in a first direction.

[0083] As shown in FIG. 8C, the handle assembly can be actuated to retract the first control member 1019 proximally while simultaneously advancing the second control member 1190 distally. In other words, retracting the first control member 1019 and pushing the second control member 1190 causes the first and second control members 1019, 1190 to pivot relative to the extensions 1028, 1080, respectively, and rotating the pivoting member 1018, resulting in deflection of the distal tool 911 in a second direction opposite the first direction. Thus, the angle between the distal tool 911 and the longitudinal axis 916 of the flexible tube 913 can be deflected upon actuation of the first and second control members 1019, 1190. However, deflection of the distal tool 911 is limited once either the first control member 1019 or the second control member 1190 contacts the inner wall of the U-shaped member 917 or the flexible tube 913. In certain embodiments, one or more of the extension 1028, extension 1080, and / or U-shaped member 917 may include a protrusion or the like that limits rotational movement of the pivot member 1018, for example, by contacting the U-shaped member 917 or the extension 1028, 1080. It should be appreciated that the pulling / pushing of the first control member 1019 and the pulling / pushing of the second control member 1190 may be performed simultaneously, or one of the first and second control members 1019, 1190 may be passively pushed / pulled after the other.

[0084] The first control member 1019 can include a bend 1030, and the second control member 1190 can include a bend 1300. As shown in Figures 8B and 8C, the bend 1030 and the bend 1300 can point in opposite directions. Additionally, the bend angle between the bend 1030 and the remainder of the first control member 1019 can be approximately the same as the bend angle between the bend 1300 and the remainder of the second control member 1190. Also, the extensions 1028 and 1080 can have a zigzag configuration, such that when the distal tool 911 is substantially aligned with the longitudinal axis 916, the extension 1028 (particularly its attachment point 1029) can be located on one side of the longitudinal axis 916 (e.g., above the longitudinal axis 916) and the extension 1080 (particularly its attachment point 1090) can be located on the other side of the longitudinal axis 916 opposite the extension 1028 (e.g., below the longitudinal axis 916). Such a zigzag configuration can correspond to the opposite directions in which the bends 1030 and 1300 extend. Thus, the range of movement that the distal tool 911 deflects in a first direction is substantially the same as the range of movement that the distal tool 911 deflects in a second direction. Furthermore, in certain embodiments, the distal tool 911 can be deflected 90 degrees relative to the longitudinal axis 916 in either direction. It should be appreciated that the extensions 1028, 1080 can have any suitable shape that increases or decreases the leverage of the first and second control members 1019, 1190 when pivoting the pivot member 1018. For example, a narrow and thin shape of the extensions 1028, 1080 can increase the leverage of the first and second control members 1019, 1190. Additionally, the location and / or strength of the connection points 1029, 1090 can increase or decrease the leverage of the first and second control members 1019, 1190 when pivoting the pivot member 1018. In some embodiments, the extensions 1028 and extensions 1080 can have different lengths.

[0085] Such a configuration may have certain advantages. For example, the distal tool 911 has a large range of motion that may be substantially the same in both directions of deflection, providing high maneuverability, which may be advantageous when maneuvering the aspirator 1000 in complex anatomical structures of the body. The high maneuverability of the distal tool 911 may also increase the area of ​​tissue that can be treated on either side of the distal tool 911 and reached for aspirating. Furthermore, similar to the embodiment of Figures 7A-7C, the configuration of the extensions 1028, 1080 with the bends 1030, 1300 provides a folded, compact structure for the positioning mechanism 1012.

[0086] 9A-9C show another embodiment of an aspiration device 1100. Similar to the embodiment of FIGS. 7A-8C, the aspiration device 1100 can include a flexible tube 913 and a distal tool 911 fluidly connected to the aspiration tube 914. The aspiration device 1100 can also include a positioning mechanism 1112 configured to deflect the distal tool 911 about a pivot axis 1115. Thus, the distal tool 911 can be connected to the flexible tube 913 proximate the pivot axis 1115. Similar to the embodiment of FIGS. 7A-8C, the positioning mechanism 1112 can include a U-shaped member 917. Additionally, the positioning mechanism 1112 can include a pivot member 1118, a first control member 1119, and a second control member 1120. Similar to the control member 919 and the first and second control members 1019, 1190, the first and second control members 1119, 1120 may include any suitable coupling device, such as a wire, rod, filament, or hollow tube.

[0087] The pivot member 1118 may be disposed within the U-shaped member 917 and coupled to the U-shaped member 917 via a first pin (or protrusion) 1122 and a second pin (or protrusion) 1123. The first pin 1122 may extend from a first side 1124 of the pivot member 1118 and rotatably connect the pivot member 1118 to a first arm 925 of the U-shaped member 917. The second pin 1123 may extend from a second side 1126 of the pivot member 1118 and rotatably connect the pivot member 1118 to a second arm 927 of the U-shaped member 917. Thus, the pivot member 1118 may be configured to rotate about the first pin 1122 and the second pin 1123.

[0088] A distal portion of the first control member 1119 can be secured to the pivot member 1118 at a first surface of the pivot member 1118, and a distal portion of the second control member 1120 can be secured to the pivot member 1118 at a second surface opposite the first surface of the pivot member 1118. The first and second control members 1119, 1120 can be secured to the pivot member 1118 by any suitable means, such as adhesives, welding, crimping, fasteners, etc. Additionally, the first and second control members 1119, 1120 can be substantially aligned with one another and disposed on opposite sides of the distal tool 911. Additionally, a suction tube 914 can be fluidly connected to the distal tool 911 between the first and second control members 1119, 1120, as described above with reference to FIGS. 7A-7C.

[0089] A suitable handle assembly (not shown) can be operatively coupled to the first control member 1119 and the second control member 1120 to manipulate the first and second control members 1119, 1120. The handle assembly can be associated with the endoscope 1, for example. As shown in FIG. 9B, the handle assembly can be actuated to retract the first control member 1119 in a proximal direction. That is, pulling the first control member 1119 can rotate the pivot member 1118 to deflect the distal tool 911 in a first direction. As shown in FIG. 9C, the handle assembly can retract (i.e., pull) the second control member 1120 in a proximal direction to rotate the pivot member 1118 to deflect the distal tool 911 in a second direction opposite the first direction.

[0090] The positioning mechanism 1112 allows the distal tool 911 to have an increased range of motion. That is, the distal tool 911 can be deflected in the first and second directions without being restricted by the first control member 1119 or the second control member 1120 contacting the U-shaped member 917 or the inner wall of the flexible tube 913. Also, the pivoting member 1118 does not have any radially outwardly extending elements like the extensions 928, 1028, 1080 of the above-mentioned embodiments. Therefore, the distal tool 911 can be more easily manipulated to increase the area of ​​tissue to be treated on either side of the distal tool 911. Furthermore, the increased range of motion allows the distal tool 911 to be deflected proximally and folded into a "switching blade" type configuration. Such a folded configuration can prevent the at least one working channel 6 from being scraped or scratched as the suction device 1100 is delivered therethrough. However, it should be appreciated that the aspirator 1100 can include any suitable restraining means for adjusting the range of travel of the distal tool 911. For example, the handle assembly can include a suitable stop configured to limit the length of the retractable first control member 1119 and / or second control member 1120. The aspirator 1100 can also include any suitable stop or limiter for limiting the rotation of the pivot member 1118, and such stop or limiter can be symmetrical or asymmetrical. In other words, such stop or limiter can allow the pivot member 1118 to rotate the same distance in both directions or different distances in both directions.

[0091] It should be appreciated that the pivoting member 918, 1018, 1118 can be generally circular or any other shape that deflects the tool 911. Additionally, the pivot axis 915, 1015, 1115 can be central or eccentric to the pivoting member 918, 1018, 1118. Additionally, in some embodiments, the control member 919 can be directly coupled to the pivoting member 918 and the first and second control members 1019, 1190 can be directly coupled to the pivoting member 1018. Depending on the attachment between the control member 919 and the pivoting member 918 and the attachment between the first and second control members 1019, 1190 and the pivoting member 1018, both pushing and pulling of the control member 919 and the first and second control members 1019, 1190 or only pulling can be performed.

[0092] 10A-10C show another embodiment of the suction device 1500 according to an exemplary disclosed embodiment. Similar to the embodiment of FIGS. 7A-9C, the suction device 1500 can include a distal tool 911 in fluid communication with a suction tube 914. The suction device 1500 can also include a deflectable elongate member 1501. The elongate member 1501 can be, for example, a catheter, and can include one or more sections that are flexible or flexible enough to allow the elongate member 1501 to be manipulated or deflected within the body and traverse complex anatomical lumens. For example, the elongate member 1501 can be uniformly flexible or can include multiple sections with different degrees of flexibility or stiffness. The suction device 1500 can also include a hub 1502 that is coupled to the distal tool 911 and the suction tube 914 at the distal end 1503 of the elongate member 1501.

[0093] As discussed above, the elongate member 1501 may be made of any suitable material that provides for deflection of the elongate member 1501. More specifically, at least the distal portion 1504 of the elongate member 1501 may be configured to deflect between a generally linear configuration and a curved, angled, or bent configuration. The distal portion 1504 may be moved to a wide range of different curved, angled, or bent configurations in a wide range of different orientations relative to the longitudinal axis 1516 of the elongate member 1501. For example, the distal portion 1504 may be configured to deflect in a first direction and a second direction in a first plane (i.e., up and down relative to the longitudinal axis 1516) and to deflect in a first direction and a second direction in a second plane different from the first plane (i.e., left and right relative to the longitudinal axis 1516). Thus, the elongate member 1501 may be configured for at least four-way steering of the distal portion 1504. However, the elongate member 1501 may be configured for steering of the distal portion 1504 in fewer or more than four directions, depending on, for example, the volume and / or shape of the internal body anatomical structure that the elongate member 1501 traverses.

[0094] To actively deflect the elongate member 1501, the distal portion 1504 can include multiple deflection sections 1557 covered by an outer sleeve 1552, as shown in Figures 10A-10C. Figures 10A-10C show the outer sleeve 1552 in a schematic manner with dotted lines illustrating the inner layers and elements of the elongate member 1501. The deflection sections 1557 can include multiple articulation points, for example, generally similar to those disclosed in U.S. Patent Application Publication No. 2010 / 0076266 to Boulais et al., which is incorporated herein by reference in its entirety. In certain embodiments, the deflection sections 1557 can be configured to deflect the distal portion 1504 up to 270 degrees relative to the longitudinal axis 1516 of the elongate member 1501 along a first plane and a second plane. In other embodiments, the deflection section 1557 can be configured to deflect the distal portion 1504 up to 270 degrees relative to the longitudinal axis 1516 of the elongate member 1501 on one of the first and second sides and up to 90 degrees relative to the longitudinal axis 1516 of the elongate member 1501 on the other of the first and second sides. However, it should be appreciated that the distal portion 1504 can be configured to be deflected at any suitable angle relative to the longitudinal axis 1516.

[0095] The one or more portions 1505 proximate the distal portion 1504 may be made of any suitable material that provides greater stiffness to the elongate member 1501 than the distal portion 1504. The one or more portions 1505 may include a material configured to provide pushability, stiffness, torqueability, and kink resistance to the elongate member 1501. For example, the one or more portions 1505 may include a stiffening sheath 1506 that is covered by an outer sleeve 1552. The stiffening sheath 1506 may be reinforced, such as by including a coil structure of tightly wound flat wire or polymeric elements. The coil structure may provide column strength and torsional stiffness to the elongate member 1501 at the one or more portions 1505, thereby enabling the elongate member 1501 to be advanced through a body lumen and / or gap. The coil structure may also provide kink resistance to prevent the one or more portions 1505 from collapsing due to bending forces applied thereto. In other embodiments, the stiffening sheath 1506 can include a network of tightly wound wires or polymer elements and / or a rigid polymer sheath made, for example, of low durometer Pebax.

[0096] Additionally or alternatively, one or more of the portions 1505 can include a material configured to provide passive deflection of the elongate member 1501. For example, instead of or in addition to the stiffening sheath 1506, one or more of the portions 1505 can include a deflection sheath that is covered by the outer sleeve 1552 and comprises a coiled structure of a material similar to the stiffening sheath 1506. However, the coil material of the deflection sheath can include a suitable cut pattern, such as a laser cut pattern. In other embodiments, the deflection sheath can include a less rigid polymer sheath, for example formed of low durometer Pebax.

[0097] As discussed above, the elongate member 1501 can include an outer sleeve 1552 that covers the distal portion 1504 and the one or more segments 1505. The outer sleeve 1552 can comprise any number of polymer sheaths, such as polyethylene, such as polyethylene with a molecular weight of 50,000 to 100,000; nylon, such as nylon 12, nylon 4-6, nylon 6-6, Pebax (polyether block amide); polyurethane; polytetrafluoroethylene (PTFE), particularly fluorinated ethylene propylene (FEP) copolymers; polyethylene impregnated with PTFE; and the like. The outer sleeve 1552 can vary the stiffness of the elongate member 1501 as desired or can enhance torque transmission and / or other desired structural properties. Additionally, the outer sleeve 1552 can be used as a convenient method of securing the distal portion 1504 and one or more segments 1505 together.

[0098] The suction device 1500 may also include one or more control members 1507 extending longitudinally through one or more portions 1505 of the elongate member 1501 and the distal portion 1504. In one exemplary embodiment, the suction device 1500 may include four control members 1507 radially spaced 90 degrees from one another about the lumen of the elongate member 1501 to provide four-way deflection of the distal portion 1504. In another embodiment, the suction device 1500 may include two control members 1507 radially spaced 180 degrees from one another about the lumen of the elongate member 1501 to provide two-way deflection of the distal portion 1504. In another embodiment, the suction device 1500 may include three control members 1507 radially spaced 120 degrees from one another about the lumen of the elongate member 1501 to provide three-way deflection of the distal portion 1504. However, it should be appreciated that the suction device 1500 can include any number of control members 1507 to control any number of polarization directions of the distal portion 1504. The control members 1507 can be constructed of any suitable material, such as stainless steel, tungsten, nitinol, etc. Additionally, the control members 1507 can be braided or bundled structures of multiple materials, such as graphite-filled polymer tubing, or can be single strand structures, such as stainless steel wire or conduit.

[0099] The control member 1507 may be attached to an inner surface of the distal portion 1504, such as the inner surface of the deflection section 1557, at or near the tip of the elongate member 1501 by any suitable fastener, weld, adhesive, or the like. Alternatively, the control member 1507 may be secured within a wall of the deflection section 1557, or may be secured to the hub 1502. The proximal end of the control member 1507 may be coupled to a suitable handle assembly. Such a configuration of the control member 1507 may thus facilitate deflection of the distal portion 1504 upon actuation of the control member 1507 (i.e., proximal retraction of one or more of the control members 1507 by the handle assembly). For example, as shown in FIG. 10A, the distal portion 1504 may be disposed in a generally linear configuration when the control member 1507 is relaxed or not actuated. As shown in Figure 10B, upon actuation of one control member 1507 (i.e., proximal retraction as indicated by the arrow), the distal portion 1504 can be deflected to a first deflected position. Further, as shown in Figure 10C, upon actuation of another control member 1507 (i.e., proximal retraction as indicated by the arrow), the distal portion 1504 can be deflected to a second deflected position different from the first deflected position.

[0100] 11A-11C show another embodiment of an aspirator 1600 according to an exemplary disclosed embodiment. Similar to the embodiment of FIGS. 7A-10C, the aspirator 1600 can include a distal tool 911 fluidly connected to an aspirator tube 914. The aspirator 1600 can also include a deflectable elongate member 1601. Similar to the elongate member 1501 of FIGS. 10A-10C, the elongate member 1601 can be, for example, a catheter, and can be flexible or include one or more flexible portions to allow the elongate member 1601 to be manipulated and deflected within the body to traverse complex anatomical lumens. For example, the elongate member 1601 can have a uniform flexibility or can include multiple portions with different flexibility or stiffness. The aspirator 1600 can also include a hub 1502 configured to be coupled to the distal tool 911 and the aspirator tube 914 at a distal end 1603 of the elongate member 1601.

[0101] The elongate member 1601 can be made of any suitable material that provides for active deflection of the elongate member 1601. At least the distal portion 1604 of the elongate member 1601 can be configured to deflect between a generally linear configuration and a curved, tilted, or bent configuration. Similar to the distal portion 1504 of the elongate member 1501, the distal portion 1604 of the elongate member 1601 can be moved in a wide variety of different directions and to a wide variety of different curves, tilts, or bends relative to the longitudinal axis 916 of the elongate member 1601.

[0102] The distal portion 1604 can be made of any suitable material configured to provide active deflection. For example, the distal portion 1604 can include a deflection sheath 1606 covered by an outer sleeve 1552, as shown in FIGS. 11A-11C. FIGS. 11A-11C show the outer sleeve 1552 in a schematic manner with dotted lines to show the inner layers and elements of the elongate member 1601. The deflection sheath 1606 can include, for example, a polymer tube with a suitable cut pattern, such as a laser cut pattern, a coiled construction of material with a laser cut pattern, and / or a polymer tube made of a material with low stiffness and high flexibility, such as low durometer Pebax. In certain embodiments, the deflection sheath 1606 can be configured to deflect the distal portion 1604 up to 270 degrees relative to the longitudinal axis 1616 of the elongate member 1601 along a first plane and a second plane. In other embodiments, the deflection sheath 1606 can be configured to deflect the distal portion 1604 up to 270 degrees relative to the longitudinal axis 1616 of the elongate member 1601 on one of the first and second sides and up to 90 degrees relative to the longitudinal axis 1616 of the elongate member 1601 on the other of the first and second sides. However, it should be appreciated that the distal portion 1604 can be configured to deflect at any suitable angle relative to the longitudinal axis 1616.

[0103] The one or more portions 1605 proximate the distal portion 1604 may be made of any suitable material that provides greater stiffness to the elongate member 1601 than the distal portion 1604. The one or more portions 1605 may include a material configured to provide pushability, stiffness, torqueability, and kink resistance to the elongate member 1601. For example, the one or more portions 1605 may include a stiffening sheath 1626 that is covered by the outer sleeve 1552. The stiffening sheath 1626 may include a coil structure of tightly wound flat wire or polymeric elements. The coil structure may provide column strength and torsional stiffness to the elongate member 1601 at the one or more portions 1605 to advance the elongate member 1601 within a body lumen and / or void. The coil structure may also provide kink resistance to prevent the one or more portions 1605 from collapsing due to bending forces applied thereto. In other embodiments, the stiffening sheath 1626 can include a rigid polymer sheath made of a braided construction of tightly wound wire or polymer elements and / or low durometer Pebax, etc. Additionally or alternatively, one or more portions 1605 can include a material configured to provide passive deflection of the elongate member 1601.

[0104] Similar to the suction device 1500, the suction device 1600 can also include one or more control members 1607 extending longitudinally through one or more portions 1605 of the elongate member 1601 and the distal portion 1604 and configured to facilitate deflection of the distal portion 1604. A distal end of the control member 1607 can be connected to an inner surface of the deflection sheath 1606 at or near the tip of the elongate member 1601. Alternatively, the control member 1607 can be fixed to the hub 1502. A proximal end of the control member 1607 can be coupled to a suitable handle assembly. As shown in FIG. 11A, when the control member 1607 is relaxed or unactuated, the distal portion 1604 can be disposed in a generally linear configuration. As shown in FIG. 11B, upon any actuation of the control member 1607 by the handle assembly (i.e., proximal retraction as indicated by the arrow), the distal portion 1604 can be deflected to a first deflected position. Additionally, as shown in FIG. 11C, upon actuation of another control member 1607 (i.e., proximal retraction as indicated by the arrow), the distal portion 1604 can be deflected to a second deflected position that is different from the first deflected position.

[0105] 12 illustrates a handle assembly 1700 for the suction devices 900, 1000, 1100, 1500, 1600. The handle assembly 1700 can include a handle housing 1701 to which the flexible tube 913 or elongate member 1501, 1601, the deflection mechanism 702, and the suction actuator 1703 can be operatively coupled.

[0106] The deflection mechanism 702 can include a deflection actuator 1704 configured to control deflection of the distal portions 1504, 1604 of the elongate members 1501, 1601 (FIGS. 10A-11C) and actuation of the positioning mechanisms 912, 1012, 1112 (FIGS. 7A-9C). One or more cams 705 can be coupled to the deflection actuator 1704 within the handle housing 1701 and supported by a frame 706. The one or more cams 705 can be rotatably supported by a central arm, such as a protrusion (not shown), and can be rotatable in response to actuation of the actuator 1704. More specifically, the one or more cams 705 can pivot about a pivot 1710 following actuation of the actuator 1704.

[0107] One or more cams 705 may be operably coupled to control member 919 (FIGS. 7A-7C), first and second control members 1019, 1190 (FIGS. 8A-8C), first and second control members 1119, 1120 (FIGS. 9A-9C), control member 1507 (FIGS. 10A-10C), or control member 1607 (FIGS. 11A-11C). Actuation of the deflection actuator 1704 may involve, for example, a thumb lever that selectively proximally retracts and / or distally advances one or more of the control members 919 (FIGS. 7A-7C), the first and second control members 1019, 1190 (FIGS. 8A-8C), the first and second control members 1119, 1120 (FIGS. 9A-9C), the control member 1507 (FIGS. 10A-10C), and the control member 1607 (FIGS. 11A-11C) by rotating one or more cams 705 in an advanced or retracted manner (indicated by a double-headed arrow). Such proximal retraction and / or distal advancement may then deflect the distal tool 911. FIG. 12 illustrates that the handle assembly 1700 is suitable for two-way steering (i.e., deflection in a first plane). However, it should be appreciated that the handle assembly 1700 can also be configured for four-way steering (i.e., deflection in a first plane and a second plane). In such a configuration, the handle assembly 1700 can include an additional deflection actuator and an additional rotatable cam similar to the deflection actuator 1704 and one or more cams 705. The additional rotatable cam can be coupled to one or more control members configured to, for example, deflect the distal portions 1504, 1604 of the elongate members 1501, 1601. The additional deflection actuator can thus be actuated, for example, by advancing or retracting the actuator to rotate the additional rotatable cam and selectively effect proximal retraction of the one or more control members to deflect the distal portions 1504, 1604 in the second plane.

[0108] As shown in FIG. 12, the suction tube 914 extends within the handle housing 1701 and can be connected to a vacuum source (not shown) external to the handle housing 1701. Although shown terminating at the proximal end of the handle assembly 1700, the suction tube 914 can terminate at any desired location on the handle assembly 1700 where it can be connected to a vacuum source. The suction actuator 1703 can be operatively coupled to the suction tube 914 within the handle housing 1701 and configured to operatively open and seal the suction through the suction tube 914 provided by the vacuum source. For example, the suction actuator 1703 can include a spring-loaded valve and an actuator, where actuation of the actuator can open and close the suction flow through the suction tube 914. In certain embodiments, a valve on the suction actuator 1703 can be actuated to close (or clamp) the suction tube 914 and block suction through the tube 14. Pressing the actuator on the suction actuator 1703 opens the valve and allows suction through the tube 14. In other embodiments, the suction actuator 1703 can be partially depressed or actuated to partially open the valve to control the amount of suction, and the valve can include any suitable structure, such as a knob, wheel, or lever, that allows any position between fully closed and fully open.

[0109] It should be appreciated that the handle assembly 1700 can include a suitable locking mechanism to lock the distal tool 911 in any suitable position. For example, the locking mechanism can secure the distal tool 911 in a deflected position and release the distal tool 911 from the deflected position as desired. For example, a clamping device can be associated with the deflection mechanism 702 and configured to lock the position of the actuator 1704.

[0110] 13A-13E show a cup device for a distal tool 911. The cup device can be an outer hollow container that houses the distal tool 911. The cup device can be coupled to the suction device 900, 1000, 1100, 1500, 1600 and the periphery of the distal tool 911. A fluid tight seal can be formed between the cup device and the portion of the suction device 900, 1000, 1100, 1500, 1600 to which it is coupled (e.g., the pivot member 918, 1018, 1118 and the hub 1502). The cup device can be configured to accommodate the size, shape, and location of the tissue to be aspirated by the distal tool 911.

[0111] 13A, the cup device 1800 can include an opening 1802 on a distal surface 1803 of the cup device 1800. The opening 1802 can include any desired shape consistent with the type and shape of tissue to be aspirated and grasped. For example, the opening 1802 can be generally circular in shape to more reliably and easily grasp generally circular tissue upon suction through the distal tool 911. Suction through the distal tool 911 can draw a desired tissue site into the opening 1802 and secure the tissue site within at least a portion of the cup device 1800. Additionally, because the opening 1802 is located on the distal surface 1803 of the cup device 1800, the tissue site immediately in front of the suction device 900, 1000, 1100, 1500, 1600 can be aspirated and grasped.

[0112] 13B, the cup device 1810 can include an opening 1811 on a side 1812 of the cup device 1810. The opening 1811 includes a generally elliptical shape, which can more reliably and easily grasp the generally elliptical shaped tissue during suction through the distal tool 911. Furthermore, because the opening 1811 is disposed on the side 1812 of the cup device 1810, tissue portions on the side of the suction device 900, 1000, 1100, 1500, 1600 can be aspirated and grasped. Furthermore, because the opening 1811 is perpendicular to the direction of suction (i.e., intersecting the distal tool 911), the suction and gripping forces can be further increased.

[0113] As shown in FIG. 13C, the cup device 1820 can have an opening 1821 on a side surface 1822 of the cup device 1820. The cup device 1820 can also have a generally cylindrical shape. The opening 1821 can have a generally elongated shape that is generally parallel to the longitudinal axis of the distal tube 11. Thus, when the distal tool 911 suctions the opening 1821, the generally elongated region of tissue extending generally parallel to the distal tool 911 can be more reliably and easily grasped. Furthermore, since the opening 1821 is located on the side surface 1822 of the cup device 1820, tissue portions on both sides of the suction device 900, 1000, 1100, 1500, 1600 can be suctioned and grasped, further increasing the suction and grasping forces.

[0114] 13D, the cup device 1830 can have an opening 1831 on a side 1832 of the cup device 1830. The cup device 1830 can be generally conical in shape. The opening 1831 can be generally elongated and generally perpendicular to the longitudinal axis of the distal tool 911. Thus, the opening 1831 can more reliably and easily grasp a generally elongated region of tissue that extends generally perpendicular to the distal tool 911 during suction by the distal tool 911. Furthermore, because the opening 1831 is located on the side 1832 of the cup device 1830, tissue portions on the side of the suction device 900, 1000, 1100, 1500, 1600 can be aspirated and grasped to further increase the suction and gripping forces.

[0115] 13E, the cup device 1840 can include an opening 1841 disposed at an angle relative to a longitudinal axis of the cup device 1840. The opening 1841 can be generally circular in shape to more reliably and easily grasp generally circular tissue upon suction by the distal tool 911. Additionally, the opening 1841 is an angled structure, allowing for suction and grasping of tissue portions in front or on the sides of the suction device 900, 1000, 1100, 1500, 1600.

[0116] It should be appreciated that the cup devices 1800, 1810, 1820, 1830, 1840 may be hollow, but may be formed of any suitable material that is sufficiently rigid to prevent the cup devices 1800, 1810, 1820, 1830, 1840 from collapsing due to the suction forces applied by the distal tool 911. Additionally, the cup devices 1800, 1810, 1820, 1830, 1840 may be formed of any suitable transparent material that allows visualization of the gripping area.

[0117] As will be appreciated by those skilled in the art, the suction device 900, 1000, 1100, 1500, 1600 of the present disclosure can enjoy a number of advantages. First, for example, the distal tool 911 can be adjusted independent of the endoscope, i.e., the position of the distal tool 911 can be changed to manipulate the positioning mechanism 912, 1012, 1112 or the control member 1507, 607 without the need to articulate, steer, displace, pull, and / or push the endoscope 1. Thus, more precise control of the position of the distal tool 911 can be provided to the physician. Also, the physician can operate and control the suction device 900, 1000, 1100, 1500, 1600 without assistance from a second operator, such as another physician or an assistant. The physician can directly and simultaneously control the position and operation (i.e., suction) of the suction device 900, 1000, 1100, 1500, 1600. Furthermore, when using the suction device 900, 1000, 1100, 1500, 1600 with an endoscope that houses multiple tools, the position of the suction device 900, 1000, 1100, 1500, 1600 can be controlled without moving other tools because there is no need to steer the entire endoscope to position the suction device 900, 1000, 1100, 1500, 1600.

[0118] In certain embodiments, the distal tool can act as a guide for inserting other endoscopic tools into the body anatomy. For example, an electrocautery loop can be fed through an insertion tube that is coupled to the distal tool. The electrocautery loop can then exit the distal tool and reach the target tissue. By activating a positioning mechanism, the distal tool, and therefore the electrocautery loop, can be deflected to a desired location.

[0119] It should further be appreciated that any of the devices 900, 1000, 1100, 1500, 1600 may include an imaging system for visualizing the body anatomy. The imaging system may include any suitable system for capturing images within the body anatomy, such as an electronic camera including optical fibers and / or an illumination unit. Thus, the device 900, 1000, 1100, 1500, 1600 may then be used without the endoscope 1 for visualization. Nevertheless, employing the device 900, 1000, 1100, 1500, 1600 with an imaging system with the endoscope 1 may provide visualization of multiple regions, including one region from the endoscope 1 and another region from the device 900, 1000, 1100, 1500, 1600.

[0120] In certain embodiments, the device 900, 1000, 1100, 1500, 1600 can be delivered through the working channel 6 of the endoscope 1 to a region at or near the target tissue to be grasped. The distal tool 911 can then be deflected towards the target tissue to apply suction through the distal tool 911. It should be appreciated that a foot pedal or button associated with the vacuum source can be actuated to activate the suction. The suction through the distal tool 911 can induce a negative pressure that grips the target tissue. The target tissue can be released by positive pressure or lack of negative pressure, achieved, for example, by depressing the suction actuator 1703 or by appropriate actuation of a foot pedal or button of the vacuum source. Once the target tissue is grasped, the distal tool 911 can be deflected to a desired position to manipulate the target tissue. For example, the distal tool 911 can be deflected to retract the target tissue by pulling and / or pushing the target tissue. The distal tool 911 can be deflected to position the target tissue so that another tool, such as a knife, dissector, or scissors delivered through another working channel 6 of the endoscope 1, can more easily reach the target tissue to cut, incise, and / or resect the target tissue.

[0121] In any of the embodiments described herein, the distal tool 911 can be offset from the longitudinal axis of the aspiration device in an initial or default position and deflected to a desired position. Additionally, the distal tool 911 can be formed of a conductive material and configured for electrocautery. Additionally, the device 900, 1000, 1100, 1500, 1600 can act as an infusion device to deliver any suitable liquid or gas through the distal tool 911. Additionally, the distal tool 911 can have any suitable flexibility characteristics. For example, the proximal portion of the distal tool 911 (e.g., the pivot member 918, 1018, 1118, the portion connected to the hub 1502) can be made of a softer, more flexible material than the remainder of the distal tool 911 or can include a bellows. In some embodiments, the entire length of the distal tool 911, excluding the proximal portion, can be reinforced with any suitable material or method. Additionally, a lumen may extend through the pivot members 918 , 1018 , 1118 and the hub 1502 to fluidly connect the distal tool 911 to the suction tube 914 .

[0122] Any aspect described in any embodiment can be used in combination with any other embodiment described herein. Any device described herein can be used in any suitable medical procedure, introduced and used through any suitable introducer needle, endoscope, and / or introducer tube, advanced through any suitable body lumen and body cavity, and used for treatment of any suitable body part. For example, the devices and methods described herein can be used in natural body lumens or canals, including oral, vaginal, or rectal access, and can be used via percutaneous applications.

[0123] Because the numerous features and advantages of the present disclosure are self-evident from the detailed description, it is the intention of the appended claims to cover all such features and advantages of the present disclosure that fall within the true spirit and scope of the present disclosure. Moreover, because numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the present disclosure to the exact construction and operation as illustrated and described, but rather all suitable modifications and equivalents may be employed and included within the scope of the present disclosure.

Claims

1. 1. A medical device, comprising: a flexible elongate member including a longitudinal axis and a distal portion; a medical end effector disposed at a distal end of the distal portion of the elongate member; Equipped with The medical end effector comprises: a hub adapted to be coupled to an electrical conductor, the hub defining a first lumen; a cylindrical distal tool defining a second lumen in fluid communication with the first lumen of the hub, the cylindrical distal tool being made of an electrically conductive material and configured to receive electrical energy; (a) a distal surface that is wider than the distal tool; and (b) the distal surface that is wider than an outer surface of the medical end effector proximal to the distal surface. a passageway extending through the second lumen of the distal tool and extending to the distal surface; A medical device comprising:

2. 2. The medical device of claim 1, wherein the distal surface is wider than the distal tool along a direction extending perpendicular to a central axis of the shaft, and the medical end effector further comprises an opening formed in the distal surface, the opening being in fluid communication with the passageway extending through a second lumen of the distal tool to the distal surface.

3. 3. The medical device of claim 1 or 2, wherein at least a portion of the medical end effector is electrically conductive.

4. The medical device of claim 3 , wherein the entire medical end effector is electrically conductive.

5. 4. The medical device of claim 1, wherein one or more portions of the medical end effector are coated with an insulating material and the distal surface of the medical end effector is blunt and rigid.

6. 6. The medical device of claim 1, wherein the medical end effector further comprises a positioning mechanism disposed at a distal end of the elongate member, the positioning mechanism configured to rotate or deflect laterally relative to a longitudinal axis of the elongate member about a pivot axis to allow an aspiration tube to access the distal tool.

7. 7. The medical device of claim 6, wherein the positioning mechanism further comprises a U-shaped member, a pivoting member, and a control member, the pivoting member being connected to the U-shaped member via a pin or hinge, the pivoting member including a lumen extending into the cylindrical distal tool.

8. The medical device of claim 1 , wherein the medical end effector further comprises a cup device at a distal end of the tubular distal tool.

9. 1. A medical device, comprising: a flexible elongate member including a longitudinal axis and a distal portion; a medical end effector disposed at a distal end of the distal portion of the elongate member; Equipped with The medical end effector comprises: a tubular distal tool defining a lumen, the distal tool being made of an electrically conductive material, the distal tool being configured to receive electrical energy; a distal surface wider than the distal tool; a passageway extending through the lumen of the distal tool to the distal surface; an opening at the distal surface in fluid communication with the passageway extending through the lumen of the distal tool to the distal surface; A medical device comprising:

10. 10. The medical device of claim 9, wherein at least a portion of the medical end effector is electrically conductive, and one or more portions of the medical end effector are coated with an insulating material.

11. 11. The medical device of claim 9 or 10, further comprising a control member or deflection sheath disposed on the distal portion of the elongate member.

12. 12. The medical device of claim 9, 10 or 11, further comprising a cup device at a distal end of the cylindrical distal tool.

13. The medical device of any one of claims 9 to 12, further comprising a positioning mechanism disposed at a distal end of the elongate member, the positioning mechanism configured to rotate or deflect laterally relative to a longitudinal axis of the elongate member about a pivot axis to allow an aspiration tube to access the distal tool, the positioning mechanism further comprising a U-shaped member, a pivot member, and a control member, the pivot member coupled to the U-shaped member via a pin or hinge, the pivot member including a lumen extending to a tubular distal tool.

14. 1. A medical device, comprising: a flexible elongate member including a longitudinal axis and a distal portion; a medical end effector disposed at a distal end of the distal portion of the elongate member; Equipped with The medical end effector comprises: a tubular distal tool defining a lumen, the distal tool being made of an electrically conductive material and configured to receive electrical energy; a planar distal surface wider than the distal tool; a passageway extending through the lumen of the distal tool to the distal surface; an opening at the distal surface and in fluid communication with the passageway extending through the lumen of the distal tool to the distal surface; and the distal surface is flat. Medical equipment.

15. a positioning mechanism disposed at a distal end of the elongate member, the positioning mechanism configured to rotate or deflect laterally relative to a longitudinal axis of the elongate member about a pivot axis to allow an aspiration tube to access the distal tool, the positioning mechanism including a U-shaped member, a pivot member, and a control member, the pivot member coupled to the U-shaped member via a pin or hinge, the pivot member including a lumen extending into a tubular distal tool; 15. The medical device of claim 14, wherein at least a portion of the medical end effector is electrically conductive, and one or more portions of the medical end effector are coated with an insulating material.

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