Endoscopic stabilizing tools and related methods of use

Abstract

To stabilize an apparatus to be used for an endoscope apparatus.SOLUTION: A system includes a member having a lumen; and a stabilizer positioned at a distal end of the lumen. The stabilizer includes at least two radially-inward projections circumferentially spaced apart from one another at the distal end of the lumen, the at least two radially-inward projections defining an opening at the distal end of the lumen; and a cross-sectional area of the opening is less than a cross-sectional area of the lumen.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Various aspects of the present invention generally relate to an endoscope device. More specifically, the present invention relates to a method of use related to the stabilization of an endoscope.

Background Art

[0002] Between both diagnostic endoscopy procedures and therapeutic endoscopy procedures, accessory devices can pass through the working channel of the endoscope. The outer diameter of the accessory device needs to be compatible with the inner diameter of the working channel. Endoscopes dedicated to diagnostic procedures generally have a smaller working channel compared to endoscopes used (for both diagnosis and treatment) in combination, or endoscopes dedicated to therapeutic procedures. For example, diagnostic and therapeutic gastric cameras usually have working channel inner diameters of 2.8 mm and 3.7 mm, respectively. Accessory devices designed for use with diagnostic scopes generally also have compatibility with therapeutic scopes. However, accessory devices designed for use with diagnostic scopes may be loosely fitted within the working channel as a result of being smaller in size when used with therapeutic scopes.

[0003] This loose fit can cause the accessory device to become unstable because the scope articulates throughout the procedure. If the accessory device becomes unstable during the procedure, there is a risk that the orientation of the device will change within the working channel as directly visually confirmed. In some procedures, the instability of the device may not be a problem, but in more precise procedures (such as intraluminal surgery), it may be a problem. During intraluminal surgery, a cutting knife may be used to excise tissue. Some existing cutting knives do not have an articulation function, and the cutting operation performed by the doctor is controlled by the joints of the scope. If the cutting knife is too small relative to the inner diameter of the working channel of the endoscope, there will be a loose fit between the knife and the working channel, and the knife may move unexpectedly when the doctor articulates the scope. This can cause something unpredictable to happen to the doctor performing the procedure and may pose a potential risk to the patient.

Summary of the Invention

[0004] The system includes a member having a lumen and a stabilizer disposed at the distal end of the lumen. The stabilizer includes at least two radially inner protrusions, and the at least two radially inner protrusions are circumferentially spaced apart from each other at the distal end of the lumen. The at least two radially inner protrusions define an opening at the distal end of the lumen, and the cross-sectional area of the opening is smaller than the cross-sectional area of the lumen.

[0005] Each of at least two protrusions is an inclined portion extending from the proximal end toward the distal end and has a radial dimension that increases as it extends from the proximal end toward the distal end. The stabilizer includes a ring-shaped support fixed within the lumen, and each inclined portion extends from the ring-shaped support into the lumen. The stabilizer includes a cap configured to extend over and cover the distal end of the scope. The stabilizer includes a first ring disposed within the lumen and a second ring disposed within the first ring and rotatable relative to the first ring, and the inclined portion extends from the second ring into the lumen. The system includes a working tool insertable into the lumen. The first ring includes a circumferential flange, and the inclined portion is configured to press the working tool against the circumferential flange. When the working tool is rotated in a first direction, the working tool rotates around the lumen in a second direction opposite the first direction along the circumferential flange. When the working tool is rotated in the first direction, the second ring also rotates in the second direction. When the first direction is clockwise, the second direction is counterclockwise, and when the first direction is counterclockwise, the second direction is clockwise. The inclined portion is configured to rotate about the central longitudinal axis of the lumen. The stabilization tool includes one or more gears configured to rotate the inclined portion. The system includes a twistable member that extends from the proximal end of the member to one of the gears, and rotation of the twistable member is configured to rotate each of the gear and the inclined portion. The free end of each of the radially inner protrusions is configured to bend distally away from the distal end of the member. The system includes a working tool insertable into the lumen, and the radially inner protrusions extend from a first side of the lumen into the lumen and are configured to be bent distally by the working tool and to press the working tool toward a second side of the lumen across the central longitudinal axis of the lumen from the first side.

[0006] The system includes a member having a lumen and a flexible stabilizer fixed to the distal end of the lumen. The flexible stabilizer is movable from a folded position to an extended position extending distally from the distal end of the lumen. The flexible stabilizer includes a central longitudinal axis, and the flexible stabilizer is pressed toward the folded position and the central longitudinal axis of the flexible stabilizer to define a tool receiving space having a cross-sectional dimension smaller than the diameter of the lumen.

[0007] The flexible stabilizer is a coil, spring, or ribbon, and the lumen includes a central longitudinal axis offset from the central longitudinal axis of the coil, spring, or ribbon. The system includes a member having a lumen, a first sleeve sized to be received within the lumen, and a first magnet disposed within or adjacent to the distal end of the lumen. The distal end of the first sleeve includes a second magnet or ferromagnetic material, the proximal end of the first sleeve is non-magnetic, and the first sleeve includes a lumen configured to receive a working tool.

[0008] The first magnet is a ring surrounding the lumen. The second magnet or ferromagnetic material of the first sleeve extends only partially around the circumference of the first sleeve, and when the first sleeve is rotated in a first direction, the first sleeve rotates around the lumen in the first direction.

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the invention and, together with the specification, serve to explain the principles of the invention.

Brief Description of the Drawings

[0010]

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DETAILED DESCRIPTION OF THE INVENTION

[0011] Next, aspects of the present invention will be referred to in detail, and examples thereof will be shown in the accompanying drawings. As far as possible, the same or equivalent reference numerals are used in the drawings to refer to the same or equivalent parts. The term "distal" refers to the part that is farthest from the user when the device is introduced into the patient. Conversely, the term "proximal" refers to the part that is closest to the user when the device is placed in the patient. As used herein, the terms "comprising," "having," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or device consisting of a list of elements does not include only those elements but may include other elements not expressly listed or elements specific to such a process, method, article, or device. The term "exemplary" is used in the sense of "example" rather than "ideal." Further, relative terms such as "about," "substantially," "approximately," etc. are used to indicate possible variations of ±10% in the recited numerical values or ranges.

[0012] Embodiments of the present invention aim to improve the stability of an accessory device (e.g., a working tool) within the lumen or working channel of a scope, such as an endoscope, particularly the stability of a tool that is smaller compared to the lumen. Similar to the elevator component of a duodenoscope, in some embodiments, an operable component may be included to provide the user with additional degrees of freedom when operating a tool at the distal end of the scope.

[0013] Figures 1 and 2 show a scope 100 extending from a proximal end (not shown) to a distal end 102. The distal end 102 may include a distally facing surface 104 having a lumen 106 (e.g., a working channel). The scope 100 may be any suitable endoscopic member, such as, for example, an endoscope, a ureteroscope, a nephroscope, a colonoscope, a hysteroscope, a uteroscope, a bronchoscope, a cystoscope, a duodenoscope, a sheath, or a catheter. The scope 100 may include one or more additional lumens configured for the passage of various therapeutic or diagnostic devices (including, but not limited to, imaging devices and tools for irrigation, vacuum aspiration, biopsy, and drug delivery). The distally facing surface 104 may also be envisioned to include an imaging device (e.g., a camera) embedded or fixed therein. At least a portion of the scope 100 may be radiopaque.

[0014] The stabilizer, i.e., the stabilization tool 108a, can be disposed at the distal end of the lumen 106. The stabilization tool 108a can be configured to stabilize and guide the working tool 120 that is movable through the lumen 106. The stabilization tool 108a can include a ring-shaped support. The ring-shaped support can be removably fixed within the distal end of the lumen 106. Alternatively, the ring-shaped support can be fixed to the body of the scope 100. If the stabilization tool 108a is removable with respect to the lumen 106, the stabilization tool 108a can be fixed within the lumen 106 by friction or interference fit, or another suitable fit. In another embodiment, the stabilization tool 108a can be provided within a cap configured to surround the distal end 102 of the scope 100 (see, e.g., cap 800 described below with respect to FIGS. 8-11). The stabilization tool 108a can be configured to accommodate and stabilize a single (exactly one) working tool 120 at a time by reducing the effective diameter of the lumen 106 at the distal end 102. For example, the stabilization tool 108a can form an opening 109 with a reduced diameter at the distal end of the lumen 106. The cross-sectional area of the opening 109 can be smaller than the cross-sectional area of the lumen 106. The cross-sectional area of the opening 109 can be, for example, from about 5% to about 95% of the cross-sectional area of the lumen 106.

[0015] The stabilization tool 108a may include one or more inclined portions 110 that extend radially into the lumen 106 from the inner circumferential surface of the stabilization tool 108a. In some embodiments, the stabilization tool 108a may include at least two inclined portions 110. The embodiment of FIG. 1 includes three inclined portions 110. The inclined portions 110 may be circumferentially spaced from each other, and each inclined portion 110 may project toward the center of the lumen 106 and the opening 109. The inclined portions 110 may extend from the proximal end 112 to the distal end 114 and may have a radially increasing dimension from the proximal end 112 to the distal end 114. In other words, the inclined portions 110 taper radially toward the proximal end 112. The inclined portions 110 may help guide a given working tool 120 distally through the lumen 106 to the reduced-diameter opening 109. (As seen in FIG. 2) The inclined portions 110 may extend radially into the lumen 106 by the maximum amount at the distal end 114. Further, the distal end 114 of the inclined portion 110 may be disposed at or slightly proximal to the most distal portion of the lumen 106. Although a plurality of inclined portions 110 are shown in FIG. 1, the stabilization tool 108a may alternatively have a single inclined portion that extends partially around the circumference of the lumen 106 (e.g., between 5 degrees and 355 degrees around the lumen 106). This range is merely exemplary, and other suitable ranges are also contemplated. The ratio of the total cross-sectional area of the distal end 114 to the cross-sectional area of the lumen 106 may be less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, or less than about 0.1. In other words, the total cross-sectional area of the inclined portions 110 may cover only a minority of the total cross-sectional area of the lumen 106. However, in some embodiments, it is also contemplated that the total cross-sectional area of the distal end 114 may cover a majority (e.g., a ratio greater than 0.5) of the cross-sectional area of the lumen 106. The inclined portions 110 may be rigid or may have some degree of flexibility.

[0016] The components of the stabilization tool 108a can be fixed relative to each other. Thus, the stabilization tool 108a can be configured to accommodate and stabilize a tool 120 within a small range of diameters (e.g., a tool having only one diameter). For example, if the stabilization tool 108a has a reduced-diameter opening 109 with a diameter of 2 mm, the stabilization tool 108a can be configured to accept only a tool 120 having a diameter of approximately 2 mm (the stabilization tool 108a of this example can accept tools 120 with smaller diameters, but such an arrangement may result in less stabilization). For a working tool 120 having a larger diameter, e.g., a diameter of 3 mm or 5 mm, two different stabilization tools 108a (each having a diameter of 3 mm and 5 mm, respectively) may be required. In some embodiments, the stabilization tool 108a can be removed from the lumen 106 by applying a distal-directed force to the proximal end 112 of the inclined portion 110, or another portion of the stabilization tool 108a. In one embodiment, the stabilization tool 108a can include a flat proximally-facing surface. A distal-directed force can be applied to the surface.

[0017] One or more portions of the stabilization tool 108a may include an adhesive coating to assist in securing the working tool 120 at the distal end 102. In some embodiments, the distal portion of the stabilization tool 108a may include an adhesive coating, while the proximal portion of the stabilization tool 108a may be uncoated or may have a lubricious coating to allow the tool 120 to slide relative to the tool 108a, e.g., on the ramp 110 of the tool 108a. The adhesive coating may include an adhesive silicone such as, for example, a moisture-curing silicone or polydimethylsiloxane. Other adhesive polymeric materials may include, for example, styrenic block copolymers (e.g., styrene-isobutylene-styrene (SIBS), styrene-ethylene / butylene-styrene (SEBS), styrene-ethylene / propylene-styrene (SEPS), styrene-isoprene-styrene (SIS)), acrylics, polyvinyl ethers, polyurethanes, ethylene copolymers, etc. For surfaces of the tool 108a with low friction (such as the radially inward surface ramp 110), various hydrophilic and lubricious coatings may be used.

[0018] The working tool 120 can be any tool known to those of ordinary skill in the art. For example, the tool can include a gripper, forceps, snare, scissors, knife, dissecting instrument, clamp, endoscopic stapler, tissue loop, clip applier, suture delivery instrument, or an energy-based tissue coagulator or cutter.

[0019] Figures 3-7 show an endoscope 100 having a stabilization tool 308 disposed within the lumen 306. The stabilization tool 308 can include an insert 309 that is insertable into the distal end of the lumen 106 or can include a cap (e.g., cap 800 described below with reference to FIGS. 8-11) configured to be disposed across the distal surface 104 of the scope 100. The stabilization tool 308 can also include a flange 310 configured to abut the distal surface 104 and an expandable member 311 movable from a folded position (e.g., FIGS. 3 and 6) to one or more expanded lock configurations (e.g., FIGS. 4 and 5). The insert 309 can have a diameter slightly smaller than the diameter of the lumen 106, while the flange 310 can have a diameter larger than the diameter of the lumen 106.

[0020] The expandable member 311 can be a coil, spring, or ribbon and can include stainless steel, nitinol, or a flexible polymer. The expandable member 311 can also include any suitable material for generating friction and grip between the working tool 120 and the expandable member 311. For example, the inner radial surface of the expandable member 311 can include an adhesive coating while the outer radial surface of the expandable member 311 can include a lubricious coating. Similar to the stabilization tool 108a, the stabilization tool 308 can be configured to receive and stabilize a working tool 120 of a single approximate diameter. However, the expandable member 311 can have a degree of flexibility depending on the thickness and shape of the material of the expandable member 311 such that the stabilization tool 308 can accommodate working tools 120 of various sizes and diameters.

[0021] The stabilization tool 308 may divide the lumen 106 into a retention region 320 and a non-retention region 322. The expandable member 311 may radially surround the retention region 320, and the non-retention region 322 may include the remainder of the lumen 106 not encompassed by the retention region 320. Thus, the combined cross-sectional area of the retention region 320 and the non-retention region 322 may be approximately equal to the cross-sectional area of the lumen 106. The central longitudinal axis 330 of the retention region 320 may be offset from the central longitudinal axis 332 of the lumen 106. The retention region 320 may be disposed adjacent to the periphery of the lumen 106. In one embodiment, the retention region 320 may abut the inner circumferential surface of the scope 100 that defines the lumen 106. At least a portion of the expandable member 311 that defines the retention region 320 may include a bias directed radially inward toward the central longitudinal axis 330 to assist in fixing the working tool 120 disposed in the retention region 320. The expandable member 311 may also be pressed toward the folded positions of FIGS. 3 and 6.

[0022] When disposed within the retention region 320, the working tool 120 may be fixed within the lumen 106. When the working tool 120 enters and passes through the non-retention region 322, it is not stabilized within the lumen 106 (e.g., loose and unrestricted within the lumen 106). Referring to FIG. 7, when the working tool 120 is disposed within the non-retention region 322, rotation of the working tool 120 about the axis of the proximal end by the user may move the working tool 120 around the circumference of the lumen 106. This rotation may occur until the working tool 120 enters the retention region 320 through the side-facing opening 324 and is locked or otherwise fixed within the retention region 320. It should be noted that only rotation in one of two directions will move the working tool 120 into the retention region 320. A lubricity coating on the radially outer surface of the expandable member 311 (and / or the surface defining the lumen 106) may assist in this rotation.

[0023] In use, the working tool 120 can be inserted through the lumen 106 and into the proximal portion of the lumen 106 and then used to push the expandable member 311 distally from the distal end 102 of the scope 100. In particular, when the working tool 120 extends distally through the holding region 320, the radially inner surface of the expandable member 311 grips the outer surface of the working tool 120 and can extend the expandable member 311 distally. In some embodiments, when the working tool 120 is retracted from the scope 100, the stabilization tool 308 can retract (e.g., recoil) to a folded position. In some embodiments, the stabilization tool 308 can be a single-use device. For example, after the working tool 120 passes through the holding region 320 and the expandable member 311 is expanded distally, the deformation that occurs in the expandable member 311 can prevent subsequent use. However, in other embodiments, the stabilization tool 308 can be suitable for multiple uses.

[0024] With reference to FIGS. 8-12, endoscope 100 is shown with stabilization tool 808 configured to accommodate and stabilize working tools 120 of different diameters. Stabilization tool 808 may include a cap 800. The cap 800 is configured to be attached to the distal end 102 of the scope 100, for example, by friction or interference fit. A flexible member 810 may extend radially inwardly from the inner circumferential surface of the cap 800. When the cap 800 is attached to the scope 100, the flexible member 810 may extend from one side of the lumen 106, toward (and in some embodiments, across) the central longitudinal axis 180 of the lumen 106, to the opposite side of the lumen 106. The flexible member 810 may be configured to bend or flex in one or more directions. For example, as shown in FIGS. 8-11, the flexible member 810 may be pressed distally by the working tool 120. The bent state of the flexible member 810 and the bias toward the state shown in FIG. 8 may urge the working tool 120 toward the opposite side of the lumen 106 while securing the working tool 120 to the opposite side. Depending on the diameter of the working tool 120, the bent position of the flexible member 810 in the locked configuration may vary. For example, (as shown in FIGS. 8-11, for example) when the working tool 120 has a first diameter, the flexible member 810 may exhibit a relatively small bend in the locked configuration. However, when the working tool 120 has a larger diameter than shown in FIGS. 8-11, the flexible member 810 may exhibit a larger bend when in the locked configuration. In the embodiments of FIGS. 8-11, a single flexible member 810 is shown, but as shown in FIG. 12, a plurality of flexible members 1210 may be alternatively utilized. The plurality of flexible members 1210 may be circumferentially spaced around the cap 800 and the lumen 106. The embodiment shown in FIG. 12 may allow for additional suction through the lumen 106 because its distal opening is less covered.

[0025] Embodiments of the present invention may function as a displacement tool for reliably positioning a working tool 120 within the lumen 106 of the scope 100. The reliable positioning of the working tool 120 by the various stabilization tools described above may enable improved user control of the working tool 120 within the particularly large lumen 106. The working tool 120 may be accurately positioned at the distal end 102, while the stabilization tool may allow the working tool 120 to move freely within the lumen 106 at the proximal end of the scope 100 and the lumen 106. The stabilization tool may be disposable or integrated into the scope 100. In the case of a disposable application, the stabilization tool may include a cap (e.g., cap 800) that covers the distal end 102 of the scope 100, or the stabilization tool may be inserted directly into the lumen 106. The stabilization tool may position the tool 120 at various different positions within the lumen 106 (e.g., at the center of the lumen or at a position along its edge). The selected position may depend on the preferred visualization and placement of the working tool 120 by the user at the distal end 102. The stabilization tool may position the tool 120 by individual contact points or by continuous circumferential contact. In some embodiments, a long circumferential member may reduce the suction ability of the scope 100, and thus individual contact points may be advantageous in applications where the lumen 106 is used for fluid suction or fluid delivery. The size and position of the contact points may be optimized to achieve the desired placement of the tool 120 and the suction ability.

[0026] In the embodiments shown in FIGS. 13 and 14, the stabilization tool 1308 can separate the lumen 106 into a tool channel 1310 and a suction channel 1312 to form a parallel tube (double tube) configuration. The tool channel 1310 can be disposed within the suction channel 1312 and can be fixed relative to the suction channel 1312. The tool channel 1310 serves to provide stability to the working tool 120 and can separate the working tool 120 from the dedicated suction channel 1312. The tool channel 1310 can have a diameter slightly larger than that of the working tool 120 to allow the working tool 120 to slide through the channel 1310, or otherwise can remain fixed within the channel. The suction channel 1312 can extend along the length of the scope 100 and can be coupled to an external waste container (not shown) outside the scope 100. The tool channel 1310 can extend through the lumen 106 to a biopsy port in the handle (not shown) of the scope 100. The double tube stabilization tool 1308 itself can also be movable within the lumen 106. In some embodiments, suction can be applied without directly inserting the distal end 102 of the scope 100 into the liquid being suctioned. For example, the entire stabilization tool 1308 can be extended distally from the distal end 102 toward the liquid such that the distal end 102 is spaced from the liquid in order to suction fluid located distal to the distal end 102. This can allow the user to maintain visualization while suction is being applied. This is because the imaging tool of the scope 100 is not submerged in the liquid during the suction procedure.

[0027] The stabilization tool of the present invention can be either passive (e.g., does not require additional user intervention to stabilize the working tool other than the insertion of the working tool 120), or active (e.g., requires or permits additional user actions to fix the working tool 120, or provides additional operator control - these examples are described below). The active displacement tool may include ON / OFF and / or direction control. The direction control of the active displacement tool can enable a user, such as a physician or other practicing doctor, to manipulate the tool 120 within the lumen 106 of the scope 100 at the distal end 102, similar to the elevator operation in a duodenoscope. The direction control of the active displacement tool can be achieved by mechanical power (e.g., twisting of the working tool 120 or knob by the user) or electric power (e.g., servo motor).

[0028] Figures 15 - 17 show a stabilization tool 1508, in which rotation about the axis of the tool 120 itself is configured to rotate the tool 120 around the lumen 106. The stabilization tool 1508 may include a first ring 1506 and a second ring 1507. The first ring 1506 and the second ring 1507 can be concentric, and the first ring 1506 can surround the second ring 1507. The first ring 1506 can be fixed to the lumen 106 by friction or interference fit, and the second ring 1507 can be configured to rotate relative to the first ring 1506. For example, the first ring 1506 and the second ring 1507 can include corresponding mechanisms. The mechanism is configured to provide relative rotation while fixing the first and second rings 1506 and 1507. Complementary mechanisms include, but are not limited to, flanges, tracks, recesses, rails, bearings, etc. Further, the inner surface of the first ring 1506 and the outer surface of the second ring 1507 that contact each other can be coated with a lubricant and / or can include a lubricious coating.

[0029] The second ring 1507 may include features similar to the stabilization tool 108a described above. For example, the second ring 1507 may include one or more inclined portions 1510 that are generally similar to the inclined portion 110 described above. Referring to FIG. 17, the inclined portion 1510 may press the working tool 120 toward the periphery of the lumen 106 and contact the circumferential flange 1506a of the first ring 1506. The flange 1506a may include an adhesive coating or may be formed of rubber or another suitable material that forms a high coefficient of friction with the outer surface of the working tool 120. Rotation of the working tool 120 about its own central axis may rotate the tool 120 around the lumen 106. For example, when the working tool 120 is rotated (in direction 1530), the tool 120 may be rotated in a direction 1532 opposite to the direction 1530 along the flange 1506a (e.g., the inner edge) of the first ring 1506. When the working tool 120 moves in the direction 1532 around the lumen 106, the working tool 120 presses the second ring 1507 that is riding on the inside of the first ring 1506 (specifically, presses the inclined portion 1510 of the second ring 1507), and may rotate the second ring 1507 in the direction 1532. In this embodiment, the material selection of the first ring 1506, the second ring 1507, and the working tool 120 may be important. This is because the second ring 1507 can rotate freely (low coefficient of friction) with respect to the first ring 1506, while the working tool 120 and the first ring 1506 (flange 1506a) should not slip (high coefficient of friction). The surface of the flange 1506a that contacts the working tool 120 may be coated with an elastomer such as neoprene, rubber, silicone, or a similar material. The first ring 1506 is a polymer to which an elastomer can adhere while maintaining a rigid shape. The second ring 1507 may include PTFE or a material having similar lubricity.

[0030] FIG. 18 shows an endoscope 100 equipped with a stabilization tool 1808 having an endoscopic cap 1806, a gripping insert 1809, and a twistable member 1810. The gripping insert may include one or more inclined portions 1812 (having any of the features described in other embodiments with inclined portions) and may secure the working tool 120 in generally the same manner as the ring 1507 described above. The gripping insert 1809 may include one or more portions that are inserted into the lumen 106 of the scope 100. Rotation of the twistable member 1810 (about the central longitudinal axis of the twistable member 1810) can rotate the gripping insert 1809 (and the working tool 120 disposed within the gripping insert 1809) around the lumen 106. The twistable member 1810 can be a cord, wire, cable, etc. that extends parallel to the length of the scope 100. The twistable member 1810 can be rotated manually by the user (e.g., via a crank) or automatically (e.g., by a servo motor). The stabilization tool 1808 may include one or more gears coupled to the cap 1806 to effectively rotate the working tool 120. The gears can be disposed distally of the distal surface 104. For example, when the endoscopic cap 1806 is disposed on the distal end 102 of the scope 100, a portion of the gear can abut the distal surface 104. The first gear 1820 can be directly coupled to the distal end of the twistable member 1810. By twisting the member 1810, the first gear 1820 can be rotated in the first direction 1840. The teeth of the first gear 1820 can be configured to interact with the teeth of the second gear 1822, thereby rotating the second gear 1822 in a second direction 1842 opposite to the first direction 1840. The teeth of the second gear 1822 can interact with the teeth of the gripping insert 1809 (and the tool 120 disposed therein) and can be configured to rotate in the first direction 1840. It is envisioned that any suitable number and type of gears in any configuration can be utilized to convert the rotational force applied to the twistable member 1810 into rotation of the gripping insert 1809.For example, in some embodiments such as when there is no second gear 1822 or when there are an even number of intermediate gears between the first gear 1820 and the grasping insert 1809, rotation of the twistable member 1810 in the first direction 1840 can cause the grasping insert 1809 and the tool 120 to rotate in the second direction 1842.

[0031] The twistable member 1810 can also extend through a biopsy port at the proximal end of the scope 100 and be disposed within the lumen 106. In this alternative embodiment, rotation of the twistable member 1810 about its central longitudinal axis can be transmitted to the stabilization tool 1808 via the first gear 1820. The second gear 1822 may or may not be incorporated depending on spacing relationships. Alternative embodiments may require a larger working channel, such as a gastric camera having a 6 mm working channel.

[0032] FIG. 19 shows a stabilization tool 1908 utilizing one or more balloons 1910 filled with liquid and / or gas. By expanding into the lumen 106 of the one or more balloons 1910, the working tool 120 can be fixed within the lumen 106. In the embodiment shown in FIG. 19, the balloon 1910 fixes the working tool 120 to the periphery of the lumen 106. However, it is envisioned that the balloon 1910 can be ring-shaped and extend around the lumen 106. In this embodiment, the inflation of the balloon 1910 can fix the working tool 120 at the center (or otherwise inside) of the lumen rather than at the periphery of the lumen. The stabilization tool 1908 can be integrated into a cap 1906. The cap 1906 is configured to be attached to the distal end 102 of the scope 100. The balloon 1910 can be adapted as part of the cap 1906. In some embodiments, the balloon 1910 is not disposed entirely inside the lumen 106, but is partially disposed in or blocks a part of the distal exit of the lumen 106. The stabilization tool 1908 can include a single (exactly one) balloon 1910 or a plurality of balloons 1910. The balloon 1910 can be filled using lens cleaning or insufflation of the scope 100, and the balloon 1910 can be coupled to a pressure relief valve (not shown) to help achieve the desired filling level or pressure of the filling fluid (e.g., lens cleaning or insufflation). When the balloon 1910 is filled to a sufficient amount, the pressure relief valve can flow excess fluid outside the scope 100 rather than through the one or more balloons 1910. In a scope 100 with a front water jet function, the front water jet 1920 (disposed in the scope 100) can be used to fill the balloon 1910. When the front water jet 1920 is actuated by the user, a portion of the water can be directed through a channel 1922 (disposed distal to the distal face of the scope 100) into the displacement balloon 1910 disposed within the lumen 106. The balloon material can be flexible (e.g., latex).The balloon 1910 can be formed in a variety of different ways (e.g., circular, cylindrical, or another suitable shape) to achieve a desired placement within the lumen 106. The balloon 1910 can be contracted by applying suction to the channel 1922. The balloon 1910 can also contract by virtue of its own elasticity. For example, when engaging the forward water jet 1920, a portion of the flow can be redirected to inflate the balloon 1910. When the forward water jet 1920 is stopped, the balloon 1910 can return to its original contracted state.

[0033] The balloon 1910 can also be filled with an external supply of liquid (e.g., filled using a syringe) or gas (e.g., compressed gas from a pressure / flow regulator). Alternatively, the interior of the balloon 1910 can also contain electroactive polymer. When an electric current is passed through the electroactive polymer, the polymer chains can expand, subsequently inflating the balloon. Using a fluidic tube instead of electrical wiring can be advantageous in managing space constraints at the distal end 102 of the scope 100.

[0034] Figures 20 - 22 illustrate embodiments incorporating a magnetic system for placing the working tool 120 within the lumen 106. A combination of ferromagnetic material and magnets can be used to properly position the working device 120 within the lumen 106.

[0035] Referring to the embodiment of FIG. 20, the stabilization device 2008 may include a first sleeve 2010 that is movable through the lumen 106. The first sleeve 2010 may include a lumen (not shown) configured to receive the working tool 120. The working tool 120 may be fixed to the first sleeve 2010 or manufactured as part of the working tool 120. The first sleeve 2010 may include one or more regions having a magnetic material (e.g., the distal portion 2010a) and one or more regions that are non-magnetic (e.g., the proximal portion 2010b). When the first sleeve 2010 is within the magnetic material range of the second sleeve 2012 or adjacent thereto, magnetic attraction can help fix the working tool 120 during the procedure. The second sleeve 2012 may be inserted into the lumen 106 and may include a magnetic material at its distal end. Alternatively, the second sleeve 2012 may be integral with the scope 100 and may include a part of the scope 100 that defines the lumen 106. The strength of the magnet (or magnets) can determine the adhesive force and can reflect the force required for the procedure. To remove the working tool 120, the magnetic field can be broken by pulling the first sleeve 2010 (and / or the working tool 120) to shear the magnetic field. The magnetic system may include two magnets (both the first sleeve 2010 and the second sleeve 2012), or one magnet and one ferromagnetic material (either the ferromagnetic second sleeve 2012 and the magnetically attractive first sleeve 2010, or the magnetically attractive second sleeve 2012 and the ferromagnetic first sleeve 2010) near the distal end 102 of the scope 100. In one embodiment, the magnet 2020 may be disposed within or adjacent to the second sleeve 2012, and the first sleeve 2010 may be ferromagnetic at its distal end. In some embodiments, the magnetically attractive or ferromagnetic second sleeve 2012 may be integrated into a cap (e.g., cap 800). The cap is placed over the distal end 102 of the scope 100 and inserted directly into the lumen 106. The magnetically attractive or ferromagnetic first sleeve 2010 is for single use and can be optimized to hold the working tool 120 firmly.In some embodiments, the first sleeve 2010 and / or the second sleeve 2012 may include a polymer shaft infused with ferromagnetic material.

[0036] The stabilization tool 2008 may position the working tool 120 at various different locations within the lumen 106 (e.g., at the center of the lumen 106 or at a location along its edge). The exact placement of the tool 120 may be adjusted for optimal visualization and accessory placement at the distal end 102.

[0037] The magnetic field of the magnet(s) can be generated using either a rare earth alloy (e.g., neodymium) or an electric current (electromagnet). The magnet(s) of the first sleeve 2010 and / or the second sleeve 2012 can have a variety of different shapes including, but not limited to, rings, bars, and disks. The first sleeve 2010 and / or the second sleeve 2012 can be ferromagnetic throughout their respective circumferences. Alternatively, they may have ferromagnetism or magnetism only at individual locations, with the remainder of the sleeve circumference being made of a non-magnetic material or polymer. By doing so, the working tool 120 can be positioned near the periphery of the lumen 106 closest to the magnetic material.

[0038] The magnetic system may be passive or active. In the case of a passive magnetic system, when the working tool 120 is inserted into the scope 100, the placement of the working tool 120 can be achieved without intervention. In a passive system, once the working tool 120 is fixed by the magnetic attraction described above, the user can operate the working tool 120 only by operating the scope 100 or by completely removing the working tool 120 from the scope. However, in the case of an active magnetic system, the placement of the working tool 120 may require additional intervention from the user. An active magnetic system may have, for example, directional control that enables a user (e.g., a physician) to maneuver (e.g., rotate) the working tool 120 around the lumen 106 of the distal end 102 (in a manner similar to the elevator movement in an endoscope, for example). The directional control of the active magnetic system can be achieved by mechanical power (e.g., twisting of the working tool 120 or a knob by the user) or electrical power (e.g., a servo motor).

[0039] The active magnetic stabilization tool 2108 is shown in FIGS. 21 and 22. The stabilization tool 2108 may include a first sleeve 2110 that is partially ferromagnetic and a second sleeve 2112 that has magnetic force. The second sleeve 2112 may include ring magnets and may be designed for single use. A part of the first sleeve 2110 may be ferromagnetic or have magnetic force (2110a), while another part may be non-magnetic (2110b). Due to the magnetic attraction between the ring magnets of the second sleeve 2112 and the ferromagnetic part of the first sleeve 2110, the working tool 120 is firmly held against the wall surrounding the lumen 106. The embodiments of FIGS. 21 and 22 may also allow for direction control by the user. By rotating the first sleeve 2110 in the direction 2130 (e.g., clockwise), since the ferromagnetic body continuously loses and recovers contact with the ring magnet, the first sleeve 2110 may move in the same direction 2130 (e.g., clockwise) around the inner edge of the ring magnet within the second sleeve 2112. It may also allow the physician to tactilely confirm, with visual feedback, that the working tool 120 has reached the distal end 102. The first sleeve 2110 may be magnetic / ferromagnetic only along a part of its circumference. For example, the magnetic / ferromagnetic material may extend around 5 to 95 percent of the circumference of the first sleeve 2010 to facilitate shearing of the magnetic field when the first sleeve 2110 is rotated. However, it is also envisioned that at least some parts of the first sleeve 2010 are magnetic / ferromagnetic around the entire circumference thereof.

[0040] It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed apparatus and methods without departing from the scope of the invention. Other aspects of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the features disclosed herein. The specification and embodiments are intended to be considered by way of example only.

Claims

1. A system comprising: a scope having a distal end and a lumen; a working tool insertable into the lumen; Stabilizer and The stabilizer comprises: a cap radially surrounding the distal end of the scope; a flexible member extending from the cap toward the lumen; wherein the flexible member is disposed distal to a distal opening of the lumen.

2. The system described in claim 1, wherein the flexible member includes a plurality of flexible members, the plurality of flexible members being circumferentially spaced around the cap.

3. The system described in claim 1, wherein the lumen is a suction lumen configured to supply negative pressure to a distal opening of the lumen.

4. The system described in claim 1, wherein the flexible member includes a plurality of flexible members, the plurality of flexible members being circumferentially spaced apart around the central axis of the lumen.

5. A system described in any one of claims 1 to 4, wherein the flexible member is positioned between the distal opening and the distal end of the cap.

6. A system described in any one of claims 1 to 4, wherein the distal end of the cap is positioned distal to the distal surface of the scope.

7. A system described in any one of claims 1 to 4, wherein the flexible member intersects with the central axis of the lumen.

8. A system described in any one of claims 1 to 4, wherein the cap includes an inner surface, and the flexible member extends from a first end of the flexible member connected to the inner surface of the cap to a second end which is a free end.

9. A system described in any one of claims 1 to 4, wherein the cap includes an inner surface, a first half of a lateral cross section, and a second half of a lateral cross section, and the flexible member extends radially inward from the inner surface and extends from only one of the first half and the second half.

10. A system as described in any one of claims 1 to 4, wherein the flexible member extends across a first side of the lumen and presses the working tool against a second side opposite the first side.

11. A system described in any one of claims 1 to 4, wherein the cap and the scope are removably coupled to each other by a friction fit or an interference fit.

12. A system described in any one of claims 1 to 4, wherein when the cap is coupled to the scope, the distal end of the cap is the distal-most end of the scope and the cap.

13. A system described in any one of claims 1 to 4, wherein a lateral cross-section of the lumen includes a first half and a second half, and the flexible member passes through the first half and only partially through the second half.

14. The system described in claim 13, wherein the flexible member presses the working tool against the second half of the lateral cross section of the lumen.

15. The system described in claim 14, wherein the flexible member is configured to deflect distally and then press the working tool against the second half of the lateral cross section of the lumen.

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