Medical devices having articulating members and methods of use - Patents.com

Abstract

A medical device including a handle, a shaft extending from the handle, first and second articulation wires coupled to the handle, and an articulation member at a distal end of the shaft, the articulation member having a central longitudinal axis in a first bending plane, the first and second articulation wires being in the first bending plane, the articulation member including a plurality of links arranged about the central longitudinal axis, a first link of the plurality of links being attached to an adjacent second link of the plurality of links via a first pair of hinges, a first hinge from the first pair of hinges being disposed on a first side of the first bending plane, and a second hinge from the first pair of hinges being disposed on a second side of the bending plane opposite the first side.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical devices and methods of use, for example, medical instruments and methods relating to using a scope to access a target site and perform a medical procedure at the target site. [Background technology]

[0002] Certain medical procedures may require articulating a portion of a medical device, such as a scope (e.g., an endoscope, a duodenoscope, a ureteroscope, etc.). For example, a medical procedure may require accessing a target site through a tortuous path by bending or articulating one or more portions of the scope.

[0003] During an endoscopic procedure, for example, a user inserts a scope into a body lumen of a patient. The user utilizes an actuating member on the handle of the endoscope to control the scope during insertion and / or during the procedure. The user may perceive a torque force when manipulating the actuating member as the scope is bent using the actuating member. For example, as the user rotates an actuating member, such as a knob, from a neutral position, the user may perceive a greater torque force as the actuating member is rotated further from the neutral position. This force may be related to the amount of material in the bending region on the scope. In some cases, reducing the material may reduce these forces. However, reducing the material may increase the difficulty of manufacturing the scope and / or may reduce the robustness of the scope. The present disclosure may solve one or more of these or other problems in the art. However, the scope of the present disclosure is defined by the appended claims, not the ability to solve a particular problem. Summary of the Invention

[0004] According to one aspect, a medical device includes a handle, a shaft extending from the handle, first and second articulation wires coupled to the handle, and an articulation member at a distal end of the shaft, the articulation member including a central longitudinal axis in a first bending plane, the first and second articulation wires being in the first bending plane, the articulation member including a plurality of links arranged about the central longitudinal axis, a first link of the plurality of links being attached to an adjacent second link of the plurality of links via a first pair of hinges, a first hinge from the first pair of hinges being disposed on a first side of the first bending plane, and a second hinge from the first pair of hinges being disposed on a second side of the bending plane opposite the first side.

[0005] Each of the first hinge and the second hinge may include a body portion having a radially outer surface that is flush with the radially outer surface of each of the first link and the second link, and each of the first hinge and the second hinge may include a protrusion extending from the body portion.

[0006] The protrusion may extend from an inner surface of the body portion toward the central longitudinal axis. Each projection may define a slot for receiving one of the first and second drive wires, and the slot may be exposed to a lumen of the articulation member.

[0007] The exposed portion of the slot in the first hinge may face the first bending plane, the exposed portion of the slot in the second hinge may face the first bending plane, and the slots in the first and second hinges may face in opposite directions.

[0008] The protrusion may have a generally semicircular cross-section and the slot may have a generally semicircular cross-section. The device may further include a first articulation lumen extending through each of the multiple links and a second articulation lumen parallel to the first articulation lumen and extending through each of the multiple links, the first articulation lumen may be in communication with a slot in the first hinge and the second articulation lumen in communication with a slot in the second hinge.

[0009] Proximal or distal movement of each of the first and second articulation wires may be configured to bend the articulation member. Each of the first and second articulation wires may be configured to move within a corresponding slot to bend the articulation member.

[0010] The first and second articulation wires may lie in a plane of bending when the articulation member is in a neutral position. Bending the articulation member in a first direction relative to a first bending plane may cause more of the first articulation wire to be exposed from the corresponding slot than the second articulation wire is exposed from the corresponding slot.

[0011] The device may further include a second pair of hinges connecting the second link to an adjacent third link, the third link being different from the first link, and the second pair of hinges may be radially offset 90 degrees relative to the first pair of hinges.

[0012] The device may further include third and fourth articulation wires coupled to the handle and lying in a second bending plane that includes the central longitudinal axis, and a first hinge from the second pair of hinges may be disposed on a first side of the second bending plane and a second hinge from the second pair of hinges may be disposed on a second side of the second bending plane opposite the first side.

[0013] Each of the pair of second hinges may include a protrusion defining a slot that receives the drive wire, and the slot of each of the pair of second hinges may be exposed to the lumen of the articulation member.

[0014] The first bending plane may be orthogonal to the second bending plane. According to another aspect, an articulation member for a medical device can include a first link, a second link, and first and second hinges connecting the first link to the second link and disposed on radially opposite sides of the articulation member, each of the first and second hinges including a slot exposed to a central lumen of the articulation member, each slot configured to receive an articulation wire.

[0015] The articulation member may further include a third link adjacent to the second link, and third and fourth hinges connecting the third link to the second link, the third and fourth hinges being radially offset 90 degrees from the first and second hinges.

[0016] The first link and the second link may define a first bending plane, and the third link and the fourth link may define a second bending plane, which may be orthogonal to the first bending plane.

[0017] The first link may be positioned on a first side of the first bending plane, the second link may be positioned on a second side of the first bending plane opposite the first side, the third link may be positioned on the first side of the second bending plane, and the fourth link may be positioned on a second side of the second bending plane opposite the first side.

[0018] According to another aspect, a method for treating a patient includes advancing a distal end of a shaft to a target site within the patient, the distal end including an articulation member having a plurality of links, adjacent links connected via a pair of hinges; actuating a first actuator to bend the articulation member relative to a bending plane, the bending plane including a central longitudinal axis of the articulation member, a first link from the pair of links being positioned on a first side of the bending plane and a second link from the pair of links being positioned on a second side opposite the first side of the bending plane, bending the articulation member such that a first articulation wire is exposed from the first hinge and a second articulation wire is covered by the second hinge; and performing a medical procedure.

[0019] The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the exemplary embodiments. [Brief description of the drawings]

[0020] [Figure 1] FIG. 1 is a schematic diagram of a medical system according to one or more aspects of the present disclosure. [Figure 2A] FIG. 2 is a perspective view of an articulating member of the medical system of FIG. 1. [Figure 2B] FIG. 2 is a perspective view of an articulating member of the medical system of FIG. 1. [Figure 3A] FIG. 2C is a side view of the articulation member of FIGS. 2A and 2B. [Figure 3B] FIG. 2C is a side view of the articulation member of FIGS. 2A and 2B. [Figure 4A] FIG. 2C is a perspective view of a segment of the articulation member of FIGS. 2A and 2B. [Figure 4B] FIG. 2C is a perspective view of a segment of the articulation member of FIGS. 2A and 2B. [Diagram 5] 5 is a cross-section of the articulating member taken along line 5-5 of FIG. 2B. [Figure 6] FIG. 2C is a side view of the articulating member of FIGS. 2A and 2B in a bent configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] The present disclosure is described with reference to an exemplary medical system for performing a medical procedure using a scope (e.g., an endoscope, a ureteroscope, a duodenoscope, a colonoscope, etc.) at a target site. Devices associated with the medical system may improve the functionality of the scope and / or improve the manufacture of the scope by reducing the forces felt by an operator or user.

[0022] Reference to any particular device or procedure is provided in this disclosure for convenience only and is not intended to limit the disclosure. Those skilled in the art will recognize that the concepts underlying the disclosed devices or methods may be utilized in any suitable device and procedure. For example, embodiments of the articulating members may be used in any medical device that requires a bending portion, including catheters, sheaths, scopes, and the like, as well as in any medical procedure, including laparoscopic, endoscopic, bronchoscopy, urological, cardiovascular, and other procedures. The present disclosure can be understood with reference to the following description and the accompanying drawings, in which like elements are referred to with the same reference numerals.

[0023] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not limiting of the claimed features. As used herein, the terms "comprises," "comprising," "having," "including," or other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements does not include only those elements, but may include other elements not expressly listed or other elements inherent to such process, method, article, or apparatus.

[0024] For ease of description, portions of the device and / or portions of its components are referred to as proximal and distal portions. It should be noted that the term "proximal" is intended to refer to the portion of the device closer to the user, and the term "distal" is used herein to refer to the portion further away from the user. Similarly, extending "distally" indicates that the component extends in a distal direction, and extending "proximally" indicates that the component extends in a proximal direction. Furthermore, as used herein, the terms "about," "approximately," and "substantially" indicate a range of values ​​within + / - 10% of the stated or implied value. Additionally, terms indicating the geometry of a component / surface include approximate shapes.

[0025] Referring to FIG. 1, a medical system 10 (also referred to herein as a medical device) according to some examples is shown. The medical system 10 includes a flexible shaft 30 (e.g., a catheter) and a handle 20 coupled to a proximal end of the flexible shaft 30. The flexible shaft 30 may include a body 40 extending from the handle 20, an articulation member 50 extending from a distal end of the body 40, and a distal portion 60 extending from a distal end of the articulation member 50. The body 40, the articulation member 50, and the distal portion 60 may be individual members connected together (e.g., by adhesive, rivets, threads, or any similar method) or may be formed as a single integral member. The medical system 10 may include one or more lumens each extending through the body 40, the articulation member 50, and the distal portion 60. The handle 20 may include a number of actuation devices (e.g., actuators) that control the articulation of the articulation members 50 in a number of directions and the movement of associated components and tools, as described herein. The handle 20, body 40, articulation members 50, and distal portion 60 extend along a central longitudinal axis A, which may define a neutral position of the articulation members 50.

[0026] 1, the handle 20 may include one or more ports 29a, 29b, 29c for inserting and / or removing tools, fluids, or other materials into and / or from a patient via the shaft 30. The port 29b may be used to introduce one or more medical instruments through a lumen (e.g., working channel) of the shaft 30. The medical instruments may be any tool, such as, but not limited to, a snare, knife, forceps, ablative laser, or other suitable tool for performing a medical procedure. A distal opening (not shown) may be disposed at a distal end face of the distal portion 60. The lumen or a different lumen may also be in communication with an umbilicus (not shown) via the port 29a for introducing fluids into the lumen and / or applying suction to the lumen. Additionally, one or more electrical cables may extend from the proximal end and / or navel of medical system 10 to articulating members 50 and / or distal portion 60 to provide a user with electrical control for imaging, illumination, and / or other electrical devices or components of medical system 10. Such electrical cables may carry imaging signals from the distal end of flexible shaft 30 proximally for processing and / or display on a display. A third port 29c may provide access to one or more of the lumens described herein.

[0027] The articulating member 50 is shown in FIG. 2A and FIG. 2B. The articulating member 50 may include multiple links 51, including a first link 51a, a second link 51b, a third link 51c, a fourth link 51d, etc. The number of links 51 is not limited. Adjacent links 51 may be connected via hinges or flexible regions. In some examples, the hinges may be "living hinges" that include a thin flexible region formed as a unitary member with adjacent links 51 and include the material of the articulating member 50. For example, the first link 51a and the second link 51b may be connected by a pair of first hinges 60a, 60b. The first hinges 60a, 60b may be positioned radially opposite one another on the articulating member 50, e.g., 180 degrees from one another about axis A. The second link 51b and the third link 51c may be connected by a pair of second hinges 62a, 62b. The second hinges 62a, 62b may be positioned radially opposite each other on the articulating member 50, e.g., 180 degrees from each other about the axis A. The second hinges 62a, 62b may be offset radially from the first hinges 60a, 60b, e.g., 90 degrees from each other about the axis A. The third link 51c and the fourth link 51d may be connected by a pair of hinges 64a, 64b. The third hinges 64a, 64b may be positioned radially opposite each other on the articulating member 50, e.g., 180 degrees from each other about the axis A.

[0028] The arrangement shown in the figures may allow articulating member 50 to be deflected in four directions (e.g., up, down, left, and right) from a neutral position along longitudinal axis A, with each direction being approximately 90 degrees to the adjacent direction. Alternatively, it will be understood that the hinges may all be positioned along articulating member 50 such that the articulating member may be deflected in only two directions (e.g., up and down, or left and right). For example, articulating member 50 may include hinges that may allow articulating member 50 to bend in only two directions. In other words, articulating member 50 may be formed with hinges 60a, 60b and hinges 64a, 64b, but not with hinges 62a, 62b. In this example, links 51b, 51c (and the corresponding links 51 that enable articulation member 50 to bend in the same direction as links 51b, 51c) may be formed as a unitary member and / or may not move relative to one another.

[0029] Articulating members 50, including links 51 and hinges, may be formed as a single, integral member, for example, by extrusion or three-dimensional (3D) printing. Alternatively, adjacent links 51 of an articulating member 50 may be attached by hinges using ultrasonic welding or the like. Materials for articulating members 50 may include plastics that may be flexible at room temperature, such as, for example, nylon, polypropylene, polyethylene, polycarbonate, etc. These materials may provide articulating members 50 with sufficient flexibility to navigate tortuous paths while also providing sufficient rigidity to accommodate medical instruments and remove tissue when performing medical procedures within the body.

[0030] 2A and 2B, each link 51 includes four articulation wire lumens 70. The lumens 70 are equally spaced about each link 51, with each lumen 70 being approximately 90 degrees about axis A from an adjacent lumen 70. Although four lumens 70 are shown, it will be understood that only two lumens 70 equally spaced about each link 51 may be provided. For example, four lumens 70 may allow the articulation member 50 to be deflected in four directions (up, down, left, and right) from a neutral position along the longitudinal axis A, whereas two lumens 70 may allow the articulation member 50 to be deflected in only two directions (up and down, or left and right). Each link 51 may also include a generally central lumen such that a lumen 56 (e.g., FIGS. 4A and 4B) may be formed through the articulation member 50 by the generally central lumen of each link 51. Lumen 56 may be in fluid communication with one or more corresponding lumens in body 40. Lumen 56 may receive one or more medical instruments (e.g., graspers, laser fibers, suction devices, scissors, scalpels, etc.) so that a medical procedure may be performed on the target tissue, as described herein.

[0031] 2B and 4B, articulation wires 80a, 80b, 80c, and 80d may be disposed within corresponding lumens 70. Each of articulation wires 80a, 80b, 80c, 80d may be connected at a distal end to a portion of distal portion 60 and / or articulation member 50 by adhesives, ultrasonic welding, crimping, or other similar techniques. Proximal ends of articulation wires 80a, 80b, 80c, 80d may be connected to articulation control devices 22 or 24. For example, articulation wires 80a, 80c may be connected to control device 22. Rotational movement of control device 22 in a first direction, e.g., a clockwise direction, may cause articulation member 50 to bend in a first direction, e.g., upward relative to longitudinal axis A. Rotating the control device 22 in a second direction, e.g., counterclockwise, may move the articulation member 50 in a second direction, e.g., down relative to the longitudinal axis A. Articulation wires 80b, 80d may be attached to the control device 24, and rotation of the device 24 in a first and second direction (e.g., clockwise and counterclockwise) may move the articulation member 50 relative to the longitudinal axis A. For example, rotating the control device 24 in a first direction may move the articulation member 50 to the right relative to the longitudinal axis A. Rotating the control device 24 in a second direction may move the articulation member 50 to the left relative to the longitudinal axis A.

[0032] One or more bending planes may be defined by a plane perpendicular to the page of Figures 3A and 3B and along the longitudinal axis A shown in Figures 3A and 3B. Each hinge (e.g., hinges 60a, 60b, etc.) lies in a corresponding bending plane when articulating member 50 is in a linear configuration, as shown in Figure 3B. Figure 3A shows articulating member 50 as shown in Figure 3B, but without articulation wires 80 for ease of understanding. Each of the bending planes may be offset by approximately 5 degrees in a clockwise and / or counterclockwise direction for each successive set of hinges. This arrangement may cause articulating member 50 to bend along a bending plane that lies along the longitudinal axis A, and drive wires 80b and 80d and their corresponding lumens 70 are in that bending plane when articulating member 50 is in a linear configuration. The offset bending plane arrangement may also cause articulating member 50 to twist in a helical shape as it bends from its proximal end to its distal end.

[0033] Additionally, a flex segment may be formed by or include any two adjacent links 51, such as flex segment 52 including links 51b and 51c. Flex segment 52 may move relative to its adjacent link 51a via hinges 60a and 60b, and flex segment 52 may move relative to its adjacent link 51d via hinges 64a and 64b.

[0034] In FIG. 3A, hinge 60a may be positioned above the bending plane and longitudinal axis A, and hinge 60b may be positioned below the bending plane and longitudinal axis A. The arrangement of the hinges and wires allows the pivot point for bending segment 52 relative to link 51a to be located on or near the bending plane and on longitudinal axis A. For example, as described above, drive wire 80b extends parallel to longitudinal axis A, as shown in FIG. 3B. Drive wire 80b may allow bending segment 52 to bend relative to link 51a at a point along drive wire 80b.

[0035] Hinge 64a may be positioned below the bending plane (e.g., the first bending plane) and the longitudinal axis A, and hinge 64b may be positioned above the bending plane and the longitudinal axis A. The arrangement of the hinges and wires allows the pivot point for bending segment 52 relative to link 51d to also be located on or near the bending plane and on the longitudinal axis A. The second bending plane may be perpendicular to the first bending plane. For example, hinge 62a may be positioned above the second bending plane and hinge 62b may be positioned below the second bending plane (see FIG. 2A). Similarly, hinge 66a may be positioned below the second bending plane and hinge 66b may be positioned above the second bending plane (FIG. 2B). This may allow articulation joint 50 to bend in a direction perpendicular to the first bending plane (e.g., up and down and left and right). Links 51a, 51b, 51c, and 51d and associated hinges 60 may form bending units 58 (FIGS. 2A, 2B, and 3A) that may enable articulating member 50 to bend right, left, up, and down, as described herein. Multiple bending units 58 may form articulating member 50. For example, articulating member 50 may include any number of bending units 58 connected in series or formed as a series integral member based on the desired and / or required length of articulating member 50. This arrangement of hinge locations above or below the bending plane may be selected by the user such that the bias or twist in bending of articulating member 50 alternates between links, offsetting each other in the plane, or compounding each other to form a helix, based on the patient's anatomy and / or the path to access the target site.

[0036] 4A and 4B show links 51a, 51b and cross-sections of adjacent hinges 62a, 62b. Some or all of the hinges throughout member 50 may have the same or similar structure as hinges 62a, 62b, as described below.

[0037] Hinge 62a may include a body portion 62a1 extending generally parallel to longitudinal axis A between links 51b and 51c. A radially outer surface of body portion 62a1 may be flush with a radially outer surface of articulation member 50. Body portion 62a1 has a width W1 measured perpendicular to axis A and along body portion 62a2, a height H1 measured perpendicular to axis A and perpendicular to width W1, and a length L1 measured parallel to axis A. Width W1 may be about 0.020 inches to about 0.150 inches (about 0.508 millimeters to about 3.81 millimeters). For example, the length of width W1 may be sufficient for body portion 62a1 to encompass the diameter of an articulation wire and include two walls of sufficient thickness on either side of the articulation wire. Length L1 may be from about 0.020 inches to about 0.200 inches (about 0.508 mm to about 5.08 mm) and may depend on the flexibility of the material and the desired bending angle of hinge 62a in each direction. The hinge (e.g., hinge 62a) may comprise a material capable of bending at operating temperatures and may comprise one or more of nylon, polypropylene, polyethylene, or polycarbonate, or any composites thereof. The material may provide articulating member 50 with a sufficient balance of flexibility during bending, sufficient resistance to compression or twisting during operation, as well as rigidity / structural integrity during manufacture of articulating member 50. The material and / or size of hinge 62a may be any suitable material to allow hinge 62a to bend or flex. Projection 62a2 may extend generally perpendicularly from body portion 62a1 toward longitudinal axis A. The protrusion 62a2 may define a generally semicircular slot 72 that may extend parallel to the longitudinal axis A. Additionally, the slot 72 may be open to the lumen 56 of the articulation member 50 (e.g., FIGS. 4A and 4B). It will be appreciated that the slot 72 may be rectangular in cross-section or any other suitable shape. The cross-sectional shape of the protrusion 62a2 may be similar to the cross-sectional shape of the slot 72, for example, it may be semicircular in shape.Semicircular slot 72 may be an extension of a corresponding lumen 70 in the links connected by hinge 62a, such as link 51b and adjacent link 51c (not shown in FIGS. 4A and 4B). Slot 72 may receive articulation wire 80a, such that a portion of articulation wire 80a may be exposed from slot 72, as shown in FIG. 4B. Wire 80a is thus exposed to lumen 56 extending through member 50.

[0038] Hinge 62b may have a similar design to hinge 62a. For example, body portion 62b2 may extend generally parallel to longitudinal axis A. Body portion 62b1 and body portion 62b2 may have dimensions similar to those of body portions 62a1 and 62a2 based on the desired articulation of articulation member 50 in a direction perpendicular to hinges 60a, 60b, which may provide sufficient stiffness to articulation member 50 during bending and / or manufacturing of articulation member 50. Each of the width, height, and length of body portion 62b1 or 62b2 may be the same as and / or different from the width W1, length L1, and height H1 of body portion 62a1 or 62a2, respectively. If the width, height, and length of each body portion are of different dimensions, a user may feel different amounts of torque when articulating articulation member 50 in different directions. The protrusion 62b2 may extend generally perpendicularly from the body portion 62b2 toward the longitudinal axis A. A generally semicircular slot 74 may be formed in the protrusion 62b2 and may extend parallel to the longitudinal axis A. Additionally, the slot 74 may be open to the lumen 56 of the articulation member 50 (e.g., FIGS. 4A and 4B). As with the slot 72, the cross-sectional shape of the slot 74 is not limited. The cross-sectional shape of the protrusion 62b2 may be similar to the cross-sectional shape of the slot 74, for example, the shape may be semicircular. The slot 74 may receive the wire 80c such that a portion of the wire 80c is exposed, as shown in FIG. 4B. Reducing the size of the protrusions 62a2, 62b2 relative to the size of a conventional hinge may reduce the amount of material of the hinges 62a, 62b. This may reduce the force required to bend articulation member 50 at hinges 62a, 62b, which may reduce the amount of torque that needs to be applied at control device 22 and / or control device 24. In this manner, the force required to bend articulation member 50 may be reduced, which may reduce fatigue and / or pain by the user. Although not shown, all of the hinges, such as hinges 60a, 60b, may be similar in cross section to hinges 62a, 62b. For example, the slots in each hinge may face in different directions, but all may open to lumen 56 of articulation member 50.

[0039] A cross section of the articulating member 50 taken along line 5-5 in FIG. 2B is shown in FIG. 5. The cross section shows the body portion 62a1 of hinge 62a and the body portion 62b1 of hinge 62b connecting link 51b and link 51c. Gaps 82 and 84 are between link 51c and link 51d. Gaps 82 and 84 are in the area between link 51c and link 51d that is not filled by hinges 64a and 64b connecting link 51c and link 51d. Each gap 82 and 84 is rectangular in cross section and may have a partial annular shape. Two gaps, e.g., gap 82 and gap 84, may be formed between adjacent links 51, e.g., link 51c and link 51d, in the area not filled by the hinges. Alternatively, gaps 82 and 84 may be V-shaped, U-shaped, or Y-shaped. Gaps 82, 84 may be variable over the length of articulating member 50 to induce particular bending behaviors and / or allow procedural access to target sites. For example, varying the size and / or location of the gaps may change the bending radius and / or amount of articulation of articulating member 50 in the superior / inferior and / or inferior / inferior left / right directions.

[0040] A cross-section of the articulation wire lumen 70 is also shown in FIG. 5. The articulation wire lumen 70 extends parallel to the longitudinal axis A. The articulation wire lumen 70 may be circular in cross-section or may have any other suitable cross-sectional shape. The distal end of each of the articulation wires 80a, 80b, 80c, 80d may be attached to the distal end 54 of the articulation member 50 using crimping, adhesive, welding, or other suitable fastening mechanisms. Alternatively or additionally, the distal end portion 60 (which may include imaging elements, illumination elements, and other structural elements including an end effector) may be attached to the distal end 54. In another example, the articulation wires 80a, 80b, 80c, 80d may be attached to the distal end portion 60. Actuation of control device 22 and / or control device 24 may cause articulation wires 80a, 80b, 80c, 80d to move proximally and distally within corresponding lumens 70 and slots between lumens 70 of link 51. Proximal movement of one or more of articulation wires 80a, 80b, 80c, 80d may cause articulation member 50 to bend from a first position generally parallel to longitudinal axis A to a second position in which articulation member 50 is angled relative to longitudinal axis A as shown in FIG 6. Distal movement of one or more of articulation wires 80a, 80b, 80c, 80d may cause articulation member 50 to bend from the second position to the first position as shown in FIG 6.

[0041] A method of performing a medical procedure is described using the medical system 10. The distal end 54 (and distal end portion 60) of the articulating member 50 may be inserted into the body via an opening (a natural orifice or an incision in the patient). Alternatively, the distal end 54 of the articulating member 50 may be advanced to the target site via an access catheter that has been previously positioned within the body.

[0042] Once the distal end 54 (and distal end portion 60) of the articulation member 50 is positioned at the target site, the articulation member 50 may be actuated. Alternatively or additionally, the articulation member 50 may be actuated as the distal end 54 advances to the target site, for example, to navigate a tortuous path. To actuate the articulation member 50, one or both of the control members 22, 24 may be actuated. For example, a user may rotate the control member 22, which may cause the articulation member 50 to move in an up and down direction. Similarly, rotation of the control member 24 may cause the articulation member 50 to move in a left and right direction. When a user rotates one or both of the control members 22, 24, the force felt by the user may be less than the force when using conventional articulation members. For example, when the control members 22, 24 are rotated and the articulation member 50 is bent relative to the longitudinal axis A (e.g., FIG. 6), reduction in material of the hinges 62, 64, 66, etc. may reduce the force required to bend the articulation member 50.

[0043] Additionally, slots 72, 74 may alternately expose and / or hide articulation wire 80 as articulation member 50 is bent relative to longitudinal axis A. For example, as articulation member 50 is bent in a first direction, hinge 62a may bend to further expose slot 72, and thus further expose articulation wire 80a. This bending motion may also bend hinge 62b to close slot 74, thereby hiding or preventing articulation wire 80c from being seen (FIG. 6). When articulation member 50 is bent in the opposite direction, slot 72 may close while further exposing slot 74. A similar movement in a direction perpendicular to hinges 62a, 62b may expose or hide the slot in hinge 64. When articulation member 50 is bent in a second direction opposite the first direction, hinge 62a may bend to close slot 72, and thus hide slot 74.

[0044] It will be appreciated that one or more instruments or tools may be advanced along lumen 56 to perform a medical procedure at the target site. The user may continue to actuate control members 22, 24 to provide access to the target site from different directions, thereby assisting in performing the medical procedure. Alternatively or additionally, tissue and / or fluid may be removed from the target site using suction, graspers, etc. Once the medical procedure is completed, articulating members 50 may be removed from the body.

[0045] It will be understood that the articulating member 50 may include any number of links 51. Furthermore, the hinges connecting the links 51 may be positioned about the articulating member 50 in any manner.

[0046] The medical system 10 may enable a user to operate a catheter, scope, sheath, or other device having articulating members using less force than conventional articulating members. In this manner, a user may perform a medical procedure in a more timely and / or cost-effective manner while minimizing injury to a patient. Additionally, the medical system 10 may have fewer manufacturing defects, which may result in a reduced cost of the medical system 10 and / or the cost of a medical procedure using the same system.

[0047] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed devices without departing from the scope of the present disclosure. Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims

1. A medical device comprising: The handle and a shaft extending from the handle; first and second articulation wires coupled to the handle; an articulation member at a distal end of the shaft, the articulation member including a central longitudinal axis within a first bending plane; the first and second articulation wires lie in the first bending plane, the articulation member includes a plurality of links arranged about the central longitudinal axis, a first link of the plurality of links attached to an adjacent second link of the plurality of links via a first pair of hinges, a first hinge from the first pair of hinges disposed on a first side of the first bending plane, and a second hinge from the first pair of hinges located on a second side of the bending plane opposite the first side.

2. 2. The device of claim 1, wherein the first hinge and the second hinge each include a body portion having a radially outer surface that is flush with the radially outer surface of each of the first link and the second link, and wherein the first hinge and the second hinge each include a protrusion extending from the body portion.

3. The device of claim 2 , wherein the protrusion extends from an inner surface of the body portion toward the central longitudinal axis.

4. The device of claim 3 , wherein each protrusion defines a slot that receives one of the first and second drive wires, the slots being exposed to the lumen of the articulation member.

5. 5. The device of claim 4, wherein the exposed portion of the slot in the first hinge faces the first bending plane, the exposed portion of the slot in the second hinge faces the first bending plane, and the slots in the first and second hinges face in opposite directions.

6. The device of claim 4 , wherein the protrusion has a generally semicircular cross-section and the slot has a generally semicircular cross-section.

7. a first articulation lumen extending through each of the plurality of links; a second articulation lumen parallel to the first articulation lumen and extending through each of the plurality of links; The device of claim 4 , wherein the first articulation lumen communicates with the slot in the first hinge and the second articulation lumen communicates with the slot in the second hinge.

8. The device of claim 2 , wherein proximal or distal movement of each of the first and second articulation wires is configured to bend the articulation member.

9. The device of claim 8 , wherein each of the first and second articulation wires is configured to move within a corresponding slot to bend the articulation member.

10. The device of claim 8 , wherein the first and second articulation wires lie within the plane of flexion when the articulation member is in a neutral position.

11. 10. The device of claim 1, wherein bending the articulation member in a first direction relative to the first bending plane causes the first articulation wire to be exposed more from the corresponding slot than the second articulation wire is exposed from the corresponding slot.

12. 10. The device of claim 1, further comprising a second pair of hinges connecting the second link to an adjacent third link, the third link being different from the first link, and the second pair of hinges being radially offset 90 degrees relative to the first pair of hinges.

13. 13. The device of claim 12, further comprising third and fourth articulation wires coupled to the handle and lying in a second bending plane that includes the central longitudinal axis, wherein a first hinge from the second pair of hinges is disposed on a first side of the second bending plane and a second hinge from the second pair of hinges is disposed on a second side of the second bending plane opposite the first side.

14. 13. The device of claim 12, wherein each of the pair of second hinges includes a protrusion defining a slot that receives a drive wire, the slot of each of the pair of second hinges being exposed to the lumen of the articulation member.

15. The device of any one of claims 12 to 14, wherein the first bending plane is orthogonal to the second bending plane.

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