A needle that moves joints

Abstract

To provide a medical device capable of optimizing a device so as to pass through an anatomical structure meandering in a flexible state and optimizing the device so as to perform a clinical task when distally positioned at a distal end of a scope in a rigid state.SOLUTION: A medical device 100 may include a needle that includes a plurality of links 108 and a distal tip 110 and is reciprocally movable between a first configuration and a second configuration, and a conduit 122 that includes a lumen 116 extending through the needle, the conduit being coupled to the distal tip, wherein a longitudinal movement of the conduit is configured to transition the needle between the first configuration and the second configuration.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Aspects of the present disclosure relate to articulating needles and related methods of use.

Background Art

[0002] Biopsies require surgically removing tissue or cells from a patient's body for pathological examination of the collected samples. The purpose of taking a biopsy sample is often to look for cell shape changes that appear within the collected sample. Identification of specific cell shape changes in the collected specimen can be helpful in identifying cancer in a patient.

[0003] During medical procedures, endoscopes are often used to access and visualize a patient's anatomical lumen. After the endoscope is positioned within the desired body part, a biopsy instrument can be advanced through the working channel of the endoscope to the desired body part. The endoscope instrument and biopsy instrument can then be manipulated as desired for visualization and specimen collection.

[0004] Smaller diameter endoscopes help reduce unnecessary trauma to a patient's tissue and provide access to a wider variety of categories of a patient's body lumens. These endoscopes often have smaller working channels, which limits the size of the auxiliary instruments that can be used with the endoscope. This then limits the size, and often the quality, of the biopsy specimen that is collected.

[0005] A needle biopsy can be performed with a stylet needle shaft having a tissue holding recess formed on the lateral side of an area near the needle tip. When the needle is inserted into the tissue where it is desired to take a sample, a portion of the tissue extends into the recess. Such a needle biopsy device often cannot be positioned within a flexible small diameter positioning device because the stylet needle for puncture is rigid.

Summary of the Invention

[0006] In one embodiment, the present disclosure relates to a medical device, which may include a needle that is reciprocally movable between a first configuration and a second configuration, comprising a plurality of links and a distal tip, and a conduit comprising a lumen extending through the needle, which is coupled to the distal tip, wherein the longitudinal movement of the conduit is configured to move the needle between the first configuration and the second configuration.

[0007] The needle may have a first stiffness in a first configuration and a second stiffness higher than the first in a second configuration. In the first configuration, applying a force to the distal tip can cause multiple links and the distal tip to reorient themselves relative to each other, while in the second configuration, applying a force to the distal tip prevents multiple links and the distal tip from reorienting themselves relative to each other. Fluid flow through the needle can pass through the lumen of the conduit and exit the needle only at the distal tip. Multiple links can rest loosely along the outer surface of the conduit in the first configuration. The medical device may include a spring configured to bias the needle into the first configuration. A proximal force applied to the conduit while the needle is in the first configuration compresses the spring, causing the needle to transition to the second configuration. Releasing the proximal force while the needle is in the second configuration may allow the needle to return to the first configuration. The medical device may include a handle having a body, an actuator movable relative to the body, a first fastener on the outer surface of the conduit, and a second fastener extending radially inward from the inner surface of the body, with a spring located between the first and second fasteners. The conduit may be coupled to the distal end of the actuator. The longitudinal movement of the conduit may be relative to a plurality of links. The conduit may be fixed at the distal end. At least one of the plurality of links may have a projection that engages with the surface of an adjacent link. The needle may include a certain radius of curvature in the second configuration. The needle may have a longer length in the first configuration than in the second configuration. The needle tip may include a distal point extending obliquely radially outward from the remainder of the distal end, the distal point may be located at the end of a path that travels along the entire length of the needle.

[0008] In another embodiment, the disclosure relates to a medical device, which may include a needle that is reciprocally movable between a first configuration and a second configuration, comprising a plurality of links and a distal tip, the second configuration being more rigid than the first configuration, and a conduit comprising a lumen extending through the needle, which is fixed to the distal tip, wherein applying a proximal pulling force to the conduit may be configured to move the needle from the first configuration to the second configuration, and releasing the proximal pulling force may be configured to move the needle from the second configuration to the first configuration.

[0009] In the first configuration, applying force to the distal tip allows multiple links and the distal tip to change direction relative to each other, while in the second configuration, applying force to the distal tip prevents multiple links and the distal tip from changing direction relative to each other. The fluid flow through the needle can pass through the lumen of the conduit and exit the needle only at the distal tip.

[0010] In yet another embodiment, the disclosure relates to a medical device. The medical device is a needle that is reciprocally movable between a first configuration and a second configuration, and which includes a plurality of links and a distal tip, and which may include a radius of curvature in the second configuration, and may include a distal point that extends obliquely radially outward from the rest of the distal tip, the distal point being located at the end of a path that travels along the entire needle, and a conduit including a lumen extending through the needle, which is fixed to the distal tip, and which may include a conduit in which a proximal pulling force is configured to move the needle from the first configuration to the second configuration, and a proximal pulling force is configured to move the needle from the second configuration to the first configuration.

[0011] The fluid flow through the needle can pass through the lumen of the conduit and exit the needle only at the distal tip. The accompanying drawings incorporated and partly present herein illustrate various embodiments and serve to illustrate the principles of the embodiments disclosed in conjunction with the description. [Brief explanation of the drawing]

[0012] [Figure 1] A side cross-sectional view of a medical device in a first configuration according to one aspect of this disclosure. [Figure 2] A side cross-sectional view of the medical device shown in Figure 1, which is part of the second configuration. [Figure 3] A side cross-sectional view of a medical device in the first configuration, according to another aspect of this disclosure. [Figure 4] Figure 3 shows a side cross-sectional view of the medical device in the second configuration. [Figure 5] A side cross-sectional view of a medical device according to another aspect of this disclosure. [Figure 6] A perspective view of the needle according to another aspect of the present disclosure. [Figure 7A] A perspective view of a link according to one aspect of this disclosure. [Figure 7B] A perspective view of a needle according to one aspect of the present disclosure. [Figure 8A] A perspective view of a link according to one aspect of this disclosure. [Figure 8B] A perspective view of a needle according to one aspect of the present disclosure. [Figure 9A] A side view of a needle in a first configuration according to one aspect of the present disclosure. [Figure 9B] A side view of the needle in Figure 9A, which is part of the second configuration. [Figure 10] A side cross-sectional view of a medical device in a first configuration according to one aspect of this disclosure. [Figure 11] A side cross-sectional view of the medical device shown in Figure 10, which is part of the second configuration. [Figure 12] A side cross-sectional view of a medical device according to another aspect of this disclosure. [Figure 13] A side view of a needle according to one aspect of the present disclosure. [Figure 14] A perspective view of a medical device according to another aspect of this disclosure. [Figure 15] A perspective view of a medical device according to another aspect of this disclosure. [Figure 16] A flowchart of a method according to one aspect of this disclosure. [Figure 17] A flowchart of a method according to another aspect of this disclosure.

Best Mode for Carrying Out the Invention

[0013] Next, refer in detail to the aspects of the present disclosure shown in the accompanying drawings. Whenever possible, the same reference numerals are used throughout the drawings to refer to the same or similar parts or components. The term "distal" refers to the direction that enters the patient's body away from the user or operator. In contrast, the term "proximal" refers to the direction that is closer to the user or operator and away from the patient's body.

[0014] Aspects of the present disclosure are directed to medical devices configured to extend beyond the distal end of a scope in a rigid state to perform various medical procedures, such as collecting tissue in a biopsy procedure or deflecting tissue from one location to another, by passing through a scope in a relaxed, flexible state. By being able to hold multiple configurations having different sizes and stiffnesses, the device can be optimized to pass through tortuous anatomical structures in a flexible state and to perform clinical tasks when positioned distally relative to the distal end of the scope in a rigid state.

[0015] Medical device 100 is shown in a first relaxed configuration in FIG. 1 and in a second rigid configuration in FIG. 2. Medical device 100 may be reciprocally movable between the first and second configurations and may be configured to extend through an endoscopic device. Medical device 100 may extend from a proximal end 102 toward a distal end 104. Medical device 100 may include a handle 106 at the proximal end 102, a plurality of links 108, and a distal tip 110. The plurality of links 108 and the distal tip 110 may form a needle 109 when medical device 100 is in the second configuration of FIG. 2.

[0016] The handle 106 may include a body 112 and an actuator 114 that is slidable or otherwise movable relative to the body 112. The body 112 may include a lumen 116 and two diametrically opposed grips 118. In some embodiments, the grips 118 may be held by a physician or other suitable operator using the index and middle fingers while the actuator 114 is held by the thumb of the same hand. A stopper 120 may extend from the inner circumferential surface of the body 112 into the lumen 116.

[0017] Links 108 and distal tip 110 may be formed from any suitable material, such as metal, alloy (stainless steel, nitinol, etc.), or polymer. Each link 108 and distal tip 110 may include a through lumen. The distal tip 110 may include a needle tip at its distal end having any suitable shape, such as a bevel tip (illustrated in Figures 1 and 2), multiple bevels, cone, sprotte, diamond, Franseen, Tuohy, or any other suitable needle tip shape. In a rigid configuration, links 108 and distal tip 110 form a needle 109 suitable for fluid injection, aspiration, biopsy sample collection, and any other suitable technique using the needle. Any suitable number of links 108 may be used, including, but not limited to, one, two, three, four, or eight or more links 108.

[0018] The conduit 122 may extend from the proximal end 102 toward the distal end 104. The conduit 122 may be fixed to the actuator 114 at the proximal end 102 and to the distal tip 110 at the distal end 104 by any preferred mechanism, such as a snap fastener, mechanical fastener, or biocompatible adhesive, or otherwise connected. One or more of the links 108 may be loosely resting along the conduit 122 in a loose configuration. The conduit 122 may include a through lumen 124 and fasteners 130 positioned on the outer circumferential surface of the conduit 122. The fasteners 130 may be distal to the fasteners 120. The conduit 122 may be formed from any preferred fluid-impermeable material, including, for example, metal or polymer. The conduit 122 may be biased toward a linear configuration (illustrated in Figures 1 and 2), but may be configured to bend to pass through meandering anatomical structures. However, after bending, the conduit 122 can return to the straight configuration shown in Figures 1 and 2. Furthermore, the conduit 122 may be stiff enough to compress the spring 132 when the medical device 100 transitions from a relaxed configuration to a rigid configuration. The spring 132 may be positioned between the fastener 120 of the handle 106 and the fastener 130 of the conduit 122.

[0019] The lumen 124 of the conduit 122 may allow fluid and / or tissue flow through the needle 109 while the needle 109 is in any configuration, including the slack configuration in Figure 1 and the rigid configuration in Figure 2. In the absence of the conduit 122, fluid and / or tissue passing through the needle 109 may escape from the needle 109 through the gaps between adjacent links 108. Even in the rigid configuration, small gaps due to manufacturing defects may exist between adjacent links 108, and in the absence of the conduit 122, the needle 109 would be unsuitable for biopsy or fluid delivery. However, in other embodiments, the needle 109 may be liquid-tight when the conduit 122 is absent while the conduit 122 is in the rigid configuration. Fluid delivery and / or inhalation devices may be coupled to the proximal end of the conduit 122 to enable sample collection, irrigation, and / or spraying of the target site. The conduit 122 may include multiple lumens to perform one or more of these functions sequentially or simultaneously.

[0020] A relaxed configuration (Figure 1) can help the medical device 100 to travel through meandering paths in the body, or through the meandering paths of the artificial lumen of the scope extending through meandering paths in the body. The medical device 100 may also be used to deflect tissue or other body structures while positioned in a rigid, compact state (Figure 2).

[0021] In a loose configuration, various links 108 can be separated from adjacent links 108 and can rest loosely along the conduit 122. In a loose configuration, the most distal link 108 can also be separated from the distal tip 110. However, in a rigid configuration, the links 108 of the medical device 100 can be in direct contact with each other in a nested state, and the most distal link 108 can be in contact with the distal tip 110 in a nested state. In a loose configuration, the links 108 and distal tip 110 of the medical device 100 can change orientation relative to each other in response to an external force acting on one or more of the links 108 or distal tip 110. In a rigid configuration, the links 108 and distal tip 110 of the medical device 100 cannot change orientation relative to each other in response to an external force acting on one or more of the links 108 or distal tip 110 (such as the same external force (magnitude and direction) described in the previous sentence). In other words, in a rigid configuration, the links 108 and distal tips 110 can form a rigid member that is substantially straight and remains substantially straight when in contact with tissue or other objects. Thus, the distal end 104 of a medical device 100 having multiple links 108 and distal tips 110 can have greater rigidity in a rigid configuration than in a loose configuration. Furthermore, the multiple links 108 and distal tips 110 may be fixed to each other in a rigid configuration and movable relative to each other in a loose configuration. The needle 900 (measured from the distal end of the handle 106) can also have a longer length in a loose configuration than in a rigid configuration because the gaps between adjacent links 108 and / or distal tips 110 that exist in a loose configuration may be closed after transitioning to a rigid configuration.

[0022] The movement of the actuator 114 relative to the main body 112 may be configured to move the medical device 100 between a loose configuration and a rigid configuration. When the medical device 100 is in the loose configuration shown in Figure 1, the actuator 114 can apply a proximal force to the conduit 122. Furthermore, since the distal tip 110 is fixed to the conduit 122, proximal movement of the conduit 122 also causes proximal movement of the distal tip 110. The distal tip 110 then contacts the most distal link of the multiple links 108, closing the gap that existed between the distal tip 110 and the most distal link 108 in the loose configuration. The most distal link 108 then contacts the link 108 immediately proximal to it, and this pattern may be repeated until the gap between each adjacent link 108 is closed. Therefore, by compressing the spring 132 in response to a proximal force, causing the gap between the distal tip 110 and the most distal link 108 and the gaps between other adjacent links of the multiple links 108, the medical device 100 can be moved from the loose configuration of Figure 1 to the rigid configuration of Figure 2. In some embodiments, a proximal force must be maintained to keep the medical device 100 in the rigid configuration, but a locking device (not shown) can be used to keep the medical device in the rigid configuration. The medical device 100 can be returned to the loose configuration by releasing the proximal force acting on the conduit 122, allowing the spring 132 to extend longitudinally and pull the links 108 and distal tip 110 of the medical device 100 apart from each other. The links 108 and distal tip 110 may be loose and slack in the loose configuration. One or more springs (not shown) may be placed between adjacent links to bias adjacent links away from each other.

[0023] Medical device 300 is shown in Figure 3 in a first loose configuration and in Figure 4 in a second rigid configuration. Medical device 300 may be reciprocating between the first and second configurations, like medical device 100, but medical device 300 may use one or more actuators 324 instead of the conduit 122 to perform the reciprocating movement between the two configurations. Medical device 300 may extend from a proximal end (not shown) toward a distal end 304. Medical device 300 may include a proximal end handle (not shown), a plurality of links 308, and a distal tip 310. The plurality of links 308 and the distal tip 310 may form a needle 309 when medical device 300 is in the second configuration of Figure 4. Medical device 300 may have substantially the same elasticity, rigidity, and other properties in both the loose and rigid configurations as those described above with respect to medical device 100.

[0024] Link 308 may be substantially similar to link 108 described above, except that link 308 may also include one or more working lumens 326. In the embodiments shown in Figures 3 and 4, each link 308 includes two working lumens 326 that are oriented opposite to each other in the diametrical direction (separated, for example, by an arc length of 180 degrees). However, it is also intended that other suitable number of working lumens and / or spacings may be used. Each link 308 may also include a fluid lumen 328 extending through the center of the link 308. When the medical device 300 is in a rigid configuration, the working lumens 326 of link 308 may be aligned with each other to form a working lumen 330, and the fluid lumens 328 may be aligned with each other to form a fluid lumen 332. The distal tip 310 may be substantially similar to the distal tip 110 described above with reference to Figures 1 and 2.

[0025] The actuating member 324 extends through each of the actuating lumens 330 (and 326) and may be coupled at their proximal ends to an actuating mechanism and / or handle. The distal end of the actuating member 324 may be coupled to a proximal-facing surface of the distal tip 310. The actuating member 324 may be a wire, cable, rod, tube, or any other suitable member configured to receive a proximal pulling force from the actuating mechanism. The actuating mechanism may include, for aspect, one or more gears, pulleys, wheels, shafts, etc., and any other suitable feature configured to apply a proximal pulling force to the actuating member 324. The actuating mechanism 124 may be motor-driven and / or electrically driven in some embodiments, and / or manually actuated by an operator.

[0026] The medical device 300 may include a sleeve 322 extending from a proximal end to a distal end 304 through a needle 309. The sleeve 322 may be formed from a polymer material, such as an elastic polymer material. Embodiments of polymers that can be used to form the sleeve 322 include, among others, Teflon®, PTFE, FEP, polyethylene and polypropylene, silicone, polyurethane and polyether block amide. The sleeve 322 may be a flexible, slack, conformable and / or impermeable membrane. That is, the sleeve 322 may have a sheet-like structure configured to collapse when no external force is applied to the sleeve 322. In some embodiments, the sleeve 322 may include an elastic and / or resilient material. The sleeve 322 may be a long, flexible rubber tube.

[0027] Figure 5 shows a medical device 500 that is substantially similar to medical device 300, except that multiple seals 522 are used instead of a single sleeve 322 to facilitate fluid flow through the medical device 500. That is, the seals 522, which may be formed from a material substantially similar to that of the sleeve 322, can be coupled to the inner surfaces of adjacent links 308 and to the inner surfaces of the most distal link 308 and the distal tip 310 to form an airtight and liquidtight seal. The seals 522 may be configured to extend axially to allow for a loosened needle configuration (not shown). In another embodiment, the seals 522 may be longitudinally positioned between adjacent links 108 and between the most distal link 308 and the distal tip 310. In this embodiment, the seals 522 may be annular O-rings or gaskets. The gaskets may be formed from a somewhat compressible elastic material to allow the gaskets to provide a substantially airtight and liquidtight seal between adjacent links 108 or between the most distal link 308 and the distal tip 310. In other embodiments, a sealing coating may be applied to the inner surface and / or end face of the link 308.

[0028] A needle 600 having an articulated joint 650 is shown in Figure 6. The articulated joint 650 may allow the needle 600 to bend and return over an arc of, for example, 180 degrees. The articulated joint 650 may generally be cylindrical in shape and may include a central lumen 652 and one or more working lumens 654 located within the wall of the articulated joint 650. There are three working lumens 654 within each joint 650, spaced 120 degrees apart from each other. However, other suitable numbers of working lumens may be used as an alternative.

[0029] To facilitate the bending of the articulated joint 650, one or more integral hinges 660 may be formed along the length of the articulated joint 650. Each integral hinge 660 may include a pair of opposing V-shaped notches 670 on either side of the articulated joint 650. The notches 670 may extend circumferentially around the articulated joint. Longitudinally adjacent integral hinges 660 may be offset from each other by 90 degrees in the circumferential direction.

[0030] Articulated joints can be formed by extruding a cylinder with the central lumen and actuating lumen in a fixed position, and then cutting the cylindrical tube with a knife, laser, milling tool, water jet, or other material removal mechanism to form an integral hinge. Alternatively, articulated joints 650 can be formed with the integral hinge in a fixed position. The angles of the V-shaped cuts 670 forming these hinges may be uniform or vary along the length of the articulated joint 650. Similarly, the distances between adjacent integral hinges 660 may be uniform or vary to adjust the bending and torque characteristics of the articulated joint 650. In one embodiment, each integral hinge 660 has a closing angle of 30 degrees, resulting in six hinges being required to produce a 180-degree movement. The actuating lumen 654 may be aligned with the widest spacing of the integral hinges 660. However, it may be desirable to offset the actuating lumen 654 relative to the hinge to reduce the potential coupling of the actuating members in the hinge. The articulated joint 650 may contain a biocompatible material that is flexible but not crushable. Suitable materials include polyurethane, polyethylene, polypropylene, or other biocompatible polymers. In another embodiment, the articulated joint 650 may be formed by 3D printing or other additive manufacturing techniques.

[0031] A distal tip 610, substantially similar to the distal tip 110, may be positioned at the distal end of the articulated joint 650. Furthermore, a sleeve, substantially similar to the sleeve 322, may extend through the needle 600 to facilitate fluid flow through the needle 600. Thus, in some embodiments, the fluid and / or tissue acquired during biopsy with the needle 600 must pass through the sleeve 322. The distal tip 610 may be long enough so that no portion of the articulated joint 650 is inserted through the tissue during biopsy acquisition. In other embodiments, the articulated joint 650 may be inserted through the tissue during sample acquisition.

[0032] Referring to Figures 7A and 7B, the needle 700 (illustrated in Figure 7B) is made up of a series of stacked links 750 positioned adjacent to each other and moving relative to each other. As shown in Figure 7A, the links 750 may include an annular ring 752 having a pair of distally facing rocker surfaces or cams 754 and a pair of proximal facing rocker surfaces or cams 756. The distally facing cams 754 may be positioned 180 degrees apart on the distal surface of the annular ring 752, while the proximal facing cams 756 may be positioned 180 degrees apart on the proximal surface of the annular ring 752. In the embodiment shown in the figure, the proximal facing cams 756 may be oriented at 90 degrees relative to the distally facing cams 754. Each cam 754 or 756 can engage with and swing relative to a flat section of an adjacent link 750. To allow the actuarial member to pass through, the hole 760 is drilled through an annular ring and through cams 754 and 756. When tension is applied to the actuarial member, the link 750 will oscillate on the surfaces of cams 754 and 756, thereby bending the needle 700 in the desired direction. When the needle 700 is assembled, the distally facing cam 754 may be aligned with other distally facing cams 754, and the proximal facing cam 756 may be aligned with other proximal facing cams 756. A distal tip 710, substantially similar to the distal tip 110, may be positioned at the distal end of the needle 700. Furthermore, a sleeve, substantially similar to the sleeve 322, may extend through the needle 700 to facilitate fluid flow through the needle 700.

[0033] Figure 8A shows a link 880, and Figure 8B shows a needle 800 including a series of stacked links 880. Each link 880 may include an annular ring having a pair of recessed pockets 882 on its proximal surface and a pair of convex cams 884 of corresponding shape on its distal surface. On a given link 880, the recessed pockets 882 may be offset by 90 degrees relative to the convex cams 884. However, the recessed pockets 882 of a given link can be aligned with and receive the convex cams 884 of an adjacent link. The correspondingly shaped cams 884 and pockets 882 help prevent the stacked links 880 from rotating relative to each other. A hole or lumen 886 is formed through the ring 880 for passing one or more actuaries 890. The hole or lumen 886 may be positioned in the center of the cams and pockets. However, the hole for the actuary may be offset from the position of the cams and pockets if desired. Link 880 may be molded from a biocompatible polymer having a relatively smooth surface to reduce friction between adjacent cams and pockets, such as polyurethane, polypropylene, or polyethylene. A distal tip 810, substantially similar to the distal tip 110, may be positioned at the distal end of the needle 800. Furthermore, a sleeve, substantially similar to the sleeve 322, may extend through the needle 800 to facilitate fluid flow through the needle 800.

[0034] Figures 9A and 9B show a needle 900 comprising a series of stacked links 980 and 981, each link comprising an annular ring having at least one pocket 982 on its proximal surface and at least one cam 984 of a corresponding shape on its distal surface. Link 981 may include an additional cam 985 extending from the distal surface of link 981 and offset circumferentially from the cam 984. The cam 985 does not have to be aligned with any corresponding pocket of an adjacent link, but instead can engage with a flat section of the proximal surface of a distally adjacent link 980 or 981 and swing with it. The cams 985 of adjacent links 981 may, in some embodiments, be located on both radially opposite sides, as shown in Figures 9A and 9B. Alternatively, the cams 985 of adjacent links 981 may be located on the same side of the needle 900 to create a greater curvature in the needle 900 as part of it. The cam 985 can drive the length and angle of the articulated section of the needle 900. By lengthening the cam 985, a longer length of the needle 900 is possible, and the angle that the needle 900 can achieve can be increased. Furthermore, by positioning various cams 985 in different planes, the articulated section can take on different shapes other than curves of a single radius, such as an S-curve.

[0035] Adjacent links 980 can be fully nested so that there is no gap between them when in a rigid configuration (illustrated in Figure 9B). However, links 981 may be only partially nested, or not nested at all with adjacent links 980 or 981. A combination of fully nested and non-nested links may allow the needle 900 to have some parts that are highly rigid in the rigid configuration and other parts that can provide the ability to change the shape and orientation of the needle 900. The needle 900 can be transitioned between a loose configuration (illustrated in Figure 9A) and a rigid configuration by acting the actuator 924 in substantially the same manner as described above with respect to the medical device 300 described with reference to Figures 3 and 4. A distal tip 910, substantially similar to the distal tip 110, can be positioned at the distal end of the needle 900. Furthermore, a sleeve, substantially similar to the sleeve 322, may extend through the needle 900 to facilitate fluid flow through the needle 900.

[0036] Medical device 1000 is shown in Figure 10 in a first flexible configuration and in Figure 11 in a second rigid configuration. Medical device 1000 may be reciprocally movable between the first and second configurations and may be configured to extend through the endoscopic device. Medical device 1000 may extend from a proximal end 1002 toward a distal end 1004. Medical device 1000 may include a handle 1006 at the proximal end 1002 and a needle 1009 extending distally from the handle 1006.

[0037] The handle 1006 may include a body 1012 and an actuator 1014 that is slidable or otherwise movable relative to the body 1012. The body 1012 may include a lumen 1016 and two diametrically opposed grips 1018. The handle 1006 may be substantially similar to the handle 106 described with reference to Figures 1 and 2. A fastener 1020 may extend from the inner circumferential surface of the body 1012 into the lumen 1016.

[0038] The needle 1009 may be formed from any suitable material, such as metal, alloy (stainless steel, nitinol, etc.), or polymer. The distal end of the needle 1009 may also include a needle tip having any suitable shape, such as a beveled tip, multiple bevels, cone, sprotte, diamond, Franseen, Tuohy, or any other suitable needle tip shape. In a rigid configuration, the needle 1009 may be suitable for fluid injection, aspiration, biopsy sample collection, and any other suitable technique using the needle. The needle 1009 may include one or more notches 1026 located on the same side of the needle 1009.

[0039] An actuator 1024 may extend distally from the actuator and be coupled to the distal end 1004 of the needle 1009. In one embodiment, the medical device 1000 includes only one actuator, but other suitable actuators may also be used. A spring 1032 may be positioned between the fastener 1020 of the handle 1006 and the actuator 1014. The spring 1032 is compressed longitudinally in the flexible configuration of Figure 10 and extends longitudinally into a stationary configuration when the medical device 1000 is in the rigid configuration of Figure 11.

[0040] The movement of the actuator 1014 and the actuation member 1024 relative to the main body 1012 may be configured to transition the medical device 1000 between a relaxed configuration and a rigid configuration. As described above, the spring 1032 is compressed longitudinally in the relaxed configuration. The actuation member 1024 is relaxed in the same configuration of the medical device 1000. When the medical device 1000 is in the relaxed configuration shown in Figure 10, the distal force on the actuator 1014 may be released, moving the actuator 1014 proximal, allowing the spring 1032 to stretch and reach the resting position shown in Figure 11. The proximal movement of the actuator 1014 may increase the tension in the actuation member 1024 until the actuation member 1024 becomes taut. This may cause the distal end of the needle 1009 coupled to the actuation member 1024 to bend away from the longitudinal axis of the medical device 1000 and close the notch 1026. The bent configuration of the needle 1009 may include a certain radius of curvature so that the needle 109 resembles an arc. The medical device 100 can be returned to a relaxed configuration by applying a distal force again to the actuator 1014 and compressing the spring 1032. This compression moves the actuator 1024 from a taut configuration to a relaxed configuration, causing the notch 1026 to reappear and the needle 1009 to return to the relaxed configuration shown in Figure 10.

[0041] The operator may need to maintain a distal force on the actuator 1014 to advance the needle 1009 through a meandering anatomical structure. Then, when the needle 1009 has advanced outside the introduction device, such as an endoscope, the operator may release the distal force and perform the biopsy procedure with the needle 1009.

[0042] A medical device 1200 is shown in Figure 12. The medical device 1200 is reciprocally movable between a first flexible configuration (not shown) and a second rigid configuration shown in Figure 12. The medical device 1200 may extend from a proximal end 1202 toward a distal end 1204. The medical device 1200 may include a handle 1206 at the proximal end 1202, a needle 1209 extending distally from the handle 1206, and an actuator 1224. The needle 1209 and actuator 1224 may be substantially similar to the needle 1009 and actuator 1024 described with reference to Figures 10 and 11.

[0043] The handle 1206 may include a body 1212 and an actuator 1214 that is slidable or otherwise movable relative to the body 1212. The body 1212 may include a lumen 1216. A fastener 1220 may extend from the inner circumferential surface of the body 1212 into the lumen 1216. The actuator 1214 may be positioned distal to the fastener 1220.

[0044] An actuating member 1224 may extend distally from the actuator 1214 and be coupled to the distal end 1204 of the needle 1209. A spring 1232 may be positioned between the fastener 1220 of the handle 1206 and the proximal surface of the actuator 1214. The spring 1232 extends longitudinally in a resting position while the medical device 1200 is in a flexible configuration (not shown) and is compressed longitudinally in the rigid configuration of Figure 12.

[0045] The movement of the actuator 1214 and the actuator 1224 relative to the body 1212 may be configured to transition the medical device 1200 between a relaxed configuration and a rigid configuration. As described above, the spring 1232 extends longitudinally in the relaxed configuration of the medical device 1200. When the medical device 1200 is in the relaxed configuration, a proximal force may be applied to the actuator 1214, moving the actuator 1214 proximal and compressing the spring 1232. The proximal movement of the actuator 1214 may deflect the distal end of the needle 1209, which is coupled to the actuator 1224, away from the longitudinal axis of the medical device 1200, and close the notch of the needle 1209. The needle 1209 may have a certain radius of curvature and may also be arc-like in other ways in this configuration. Therefore, in response to a proximal force, the medical device 1200 can move from a relaxed configuration to the rigid configuration shown in Figure 12 by compressing the spring 1232. In some embodiments, the proximal force must be maintained in order to keep the medical device 1200 in the rigid configuration. The medical device 1200 can be returned to the relaxed configuration by releasing the proximal force acting on the actuating member 1224 and actuator 1214, allowing the spring 1232 to extend longitudinally, causing the notch to reappear, and returning the needle 1209 to a relaxed configuration similar to the configuration shown in Figure 10.

[0046] The medical device 1200 may be configured so that no additional force is required to advance the medical device 1200 through meandering anatomical structures (other than the force required to move the medical device 1200 itself). Instead, after the medical device 1200 is positioned adjacent to the work site, a proximal force can be applied to the actuator 1214 to move the needle 1209 into a rigid configuration suitable for collecting a biopsy sample.

[0047] A needle 1300 is shown in Figure 13. The needle 1300 may extend from a proximal end 1302 toward a distal end 1304. The needle 1300 may be substantially similar to any of the needles described herein and may include a distal point 1308 that extends obliquely radially outward from the distal tip 1306 of the needle 1300. The distal point 1308 may be the most distal point of the path that travels along the entire length of the needle 1300. The distal point 1308 may be a permanent part of the needle 1300 that is present in all configurations of the needle 1300, rather than being present in only some configurations of the needle 1300. Thus, as the needle 1300 travels along, curves, extends, or compresses along a meandering anatomical structure, the distal point 1308 may remain invariant with respect to the rest of the distal tip 1306. The distal point 1308 may be the initial portion of the needle 1300 that punctures the tissue, and its radially outward orientation may cause the remainder of the needle 1300 to follow a path 1311 through the tissue that is offset from the longitudinal central axis 1310 of the needle 1300. That is, after the distal point 1308 punctures the tissue, in response to a force directed along the longitudinal central axis 1310, the needle 1300 may bend and follow the path 1311 through the tissue.

[0048] Scope 1400 is shown in Figure 14. Scope 1400 may include a flexible shaft 1401 extending from a proximal end 1402 to a distal end 1404. The shaft 1401 may be configured to traverse anatomical structures within the patient. In some embodiments, the shaft 1401 may be uniformly flexible or comprise portions with varying degrees of flexibility. For example, the distal end 1404 of the shaft 1401 may be more flexible than the proximal end 1402. Scope 1400 may be any suitable medical scope, such as an endoscope, ureteroscope, colonoscope, hysteroscope, bronchoscope, or cystoscope. The shaft 1401 may be inserted directly into the patient's body or extended across a guidewire using one or more lumens. Alternatively, the shaft 1401 may be inserted into a laparoscopic port, a single incision port, an overtube, a bush, or any other suitable component.

[0049] The shaft 1401 may include a single lumen 1412 (for example, just one lumen), but any other preferred number of lumens may be used. In part, an additional lumen 1415 may be configured to house any preferred visual device. In part, the lumen 1415 may be configured to include a visual device that allows the user to view the area adjacent to the distal end 1404 of the scope 1400, including the distal end 1404, from the distal area. The visual device may be built into the scope 1400 and may include a light source, lenses, optical fibers, and / or any preferred electronic vision components known in the art, etc., for viewing the work site within the body lumen of the patient. In another embodiment, a separate imaging device may be used. Further additional lumens (not shown) may be used for any other preferred purposes, such as irrigation, inhalation, suction, delivery of additional tools, delivery of therapeutic agents, or as guide lumens used to guide the shaft 1401 across the guidewire.

[0050] The tool 1414 may extend through the lumen 1412. The tool 1414 may include a blade, cutting wire, hypodermic needle, needle knife, snare, or other therapeutic or diagnostic device, including any of the devices described herein.

[0051] The deflection tool 1416 may be coupled to the outer surface of the shaft 1401. The deflection tool 1416 may be substantially similar to any of the medical devices and / or needles described herein that are movable between a loose configuration and a rigid configuration. However, in some embodiments, the deflection tool 1416 may have a non-sharp, non-traumatic distal tip instead of a sharp distal tip. The non-traumatic tip may be configured to reduce or prevent damage to the tissue to which the non-traumatic tip makes contact. In some embodiments, the non-traumatic tip may comprise a polymer material having a relatively low durometer or hardness. In other embodiments, the non-traumatic tip may comprise any other features, such as a ball tip or a rounded edge, configured to reduce damage to the tissue to which the tip makes contact.

[0052] The deflection tool 1416 may be used to deflect tissue or other body structures while positioned in a rigid configuration, and may also be used to hold and position tissue before or during manipulation or excision. In some embodiments, the deflection tool 1416 may be positioned adjacent to or in contact with the tissue to be excised or biopsy, transition to a rigid state, and push or deflect the tissue to the optimal cutting position. In some embodiments, the deflection tool may be used to tense the target tissue and facilitate the cutting of the target tissue.

[0053] A scope 1500, substantially similar to scope 1400, is shown in Figure 15, but scope 1500 may include at least one additional lumen 1513. A deflection tool 1516 may extend through the additional lumen 1513. The deflection tool 1516 may be substantially similar to and may be used substantially similarly to the deflection tool 1416. The aperture of lumen 1513 at the distal end of scope 1500 may be in a plane, and the deflection tool 1516 may be configured to extend distally away from the distal end 1504 along a trajectory substantially perpendicular to the plane of the aperture.

[0054] The articulated needle of this disclosure may comprise only two configurations in some embodiments. In some embodiments, the two configurations of the needle may be offset from each other by 45 degrees. In other embodiments, the articulated needle may be continuously variable using a back tension spring or a link of incomplete notches, which would allow the needle to return to its initial shape when no tension is applied by the user.

[0055] One or more parts of the disclosed medical device and needle may include a lubricating coating to reduce friction between the medical device or needle and the tissue that comes into contact with it. Otherwise, any suitable lubricating coating may be used, including a water-soluble biocompatible compound that provides lubrication to the surface of a non-lubricating material. One type of hydrophilic coating includes a hydrogel that swells in an aqueous environment and exhibits lubricity while wet or hydrated. When hydrated, these substances have low friction in bodily fluids, including saliva, digestive fluids, and blood, and in physiological saline and water. Hydrogels optionally include poly(meth)acrylate polymers or copolymers, maleic anhydride copolymers, (meth)acrylamide polymers and copolymers, (meth)acrylic acid copolymers, polyurethanes, poly(vinylpyrrolidone), and blends or interpolymers of polyurethanes, polysaccharides, and mixtures thereof, crosslinked or interpolymerized with polyurethane or ureid bonds to the substrate surface.

[0056] Furthermore, the medical devices of this disclosure may be coated with an antimicrobial coating to inhibit bacterial colony growth on their surface. The antimicrobial coating may include an inorganic antimicrobial agent placed in a polymer matrix that adheres the antimicrobial agent to the device surface. In addition, a drug-release coating may be applied to the device surface to help deliver drugs to the biopsy site. In another alternative example, imaging markers may be applied to various medical devices to help locate the medical devices within the body. Radiopaque, sonoreflective, and / or any other suitable markers may be used.

[0057] Method 1600 is shown in Figure 16. Method 1600 may begin in step 1602, in which an endoscope or other suitable component may be inserted into the body and advanced to a target area. In part, the endoscope may be inserted into the body through a natural anatomical opening such as the mouth, anus, nose, or vagina. Alternatively, the endoscope may be inserted into the body through an incision. The operator may advance the endoscope from the insertion point to the target area (e.g., the work site) within the body by traversing a body pathway, such as the biliary system. In other embodiments, the work site may include a lymph node or any other tissue that may be potentially cancerous and has been identified for biopsy and further investigation.

[0058] After the distal end of the endoscope is adjacent to or otherwise approaching the target area, in step 1604, a needle according to any aspect of the present disclosure may be inserted through the port of the endoscope while in a relaxed configuration. The relaxed needle may then be pushed toward the distal end of the endoscope. After the needle has exited the distal end of the endoscope, the method may proceed to step 1606, in which the needle may be transitioned from a relaxed configuration to a rigid configuration. After the needle is in a rigid configuration, the needle may be extended further distally from the scope in step 1608 to puncture tissue and collect a sample. Step 1608 may be repeated several times around and / or through the same target area (e.g., an eccentric lesion) to obtain tissue samples from multiple portions of the target area (e.g., a sector). Multiple samples can be taken while keeping the introducing endoscope in a fixed position, which can result in a significant reduction in procedure time.

[0059] Method 1700 is shown in Figure 17. Step 1702 may be substantially similar to step 1602 of Method 1600, but a scope 1400 or 1500 may be used instead of the endoscope described with reference to Method 1600. After the scope 1400 or 1500 is adjacent to the target or otherwise close to the target area, in step 1704 the deflection tool 1416 or 1516 may be transitioned from a loose configuration to a rigid configuration to prepare the tissue for manipulation, cutting, or excision. After the tissue is prepared, the subsequent procedure (e.g., cutting) may be performed by the tool 1414 in step 1706.

[0060] Those skilled in the art will understand that the medical devices described above can be implemented in any suitable body lumen (e.g., blood vessels, biliary tract, urinary tract, digestive tract lumen, etc.) without departing from the scope of this disclosure as defined by the claims. In particular, structural details, including manufacturing techniques and materials, are within the full understanding of those skilled in the art and are not described in detail here. These and other modifications and variations are sufficiently within the scope of this disclosure and can be foreseen and implemented by those skilled in the art.

[0061] Other aspects of this disclosure will become apparent to those skilled in the art by examining this specification and practicing the embodiments disclosed herein. This specification and its embodiments are intended to be merely forms of implementation, and deviations in form and detail may be made without departing from the scope and spirit of this disclosure as defined by the following claims. The technical concepts included in this disclosure are described below. (Note 1) A needle comprising multiple links and a distal tip, which is capable of reciprocating between a first configuration and a second configuration, A medical device comprising a conduit including a lumen extending through the needle, the conduit being coupled to the distal end, wherein longitudinal movement of the conduit is configured to move the needle between the first configuration and the second configuration. (Note 2) The needle has a first rigidity in the first configuration and a second rigidity that is higher than the first rigidity in the second configuration, and in the first configuration, by applying force to the distal tip, the plurality of links and the distal tip are rotated relative to each other, and in the second configuration, by applying the force to the distal tip, the plurality of links and the distal tip are not rotated relative to each other, as described in Appendix 1. (Note 3) The medical device according to Appendix 1 or Appendix 2, wherein the fluid flow through the needle passes through the lumen of the conduit, causing the needle to emerge only at the distal tip. (Note 4) The medical device according to any one of the appendices 1 to 3, wherein the plurality of links are loosely resting along the outer surface of the conduit in the first configuration. (Note 5) The medical device according to any one of appendices 1 to 4, further comprising a spring configured to bias the needle to the first configuration. (Note 6) The medical device according to Appendix 5, wherein a proximal force applied to the conduit while the needle is in the first configuration compresses the spring and moves the needle to the second configuration. (Note 7) The medical device according to Appendix 6, wherein the needle can be returned to the first configuration by releasing the proximal force while the needle is in the second configuration. (Note 8) The medical device according to Appendix 6, further comprising a handle having a body, an actuator movable relative to the body, a first fastener on the outer surface of the conduit, and a second fastener extending radially inward from the inner surface of the body, wherein the spring is located between the first fastener and the second fastener. (Note 9) The conduit is connected to the distal end of the actuator, as described in Appendix 7, for the medical device. (Note 10) The medical device according to any one of the appendices 1 to 9, wherein the longitudinal movement of the conduit is relative to the plurality of links. (Note 11) The conduit is a medical device according to any one of the appendices 1 to 10, which is fixed to the distal tip. (Note 12) The medical device according to any one of the appendices 1 to 11, wherein at least one of the plurality of links has a projection that engages with the surface of an adjacent link. (Note 13) The needle is a medical device according to any one of the appendices 1 to 12, wherein the needle includes a certain radius of curvature in the second configuration. (Note 14) The medical device according to any one of appendices 1 to 13, wherein the needle has a longer length in the first configuration than in the second configuration. (Note 15) The medical device according to any one of appendices 1 to 14, wherein the needle tip includes a distal point that extends obliquely radially outward from the remaining portion of the distal tip, and the distal point is located at the end of a path that travels along the entire length of the needle.

Claims

1. A tool comprising at least a first link and at least a second link, having both a loose configuration and a rigid configuration, wherein when the tool is in the loose configuration, the first link and the second link are separated from each other and movable relative to each other such that a gap is formed between the first link and the second link, and each link is further, An annular ring including the proximal and distal surfaces, A cam configured to contact the corresponding surface of an adjacent link and Tools, including An operating member extending through the first link and the second link, It comprises a distal tip positioned distal to the first link and the second link, The actuating member is fixed to the distal tip, and in response to the movement of the actuating member relative to the tool, adjacent links come into contact with each other via corresponding cams, causing the tool to transition from the loose configuration to the rigid configuration. The tool is a medical device having higher rigidity in the rigid configuration than in the loose configuration.

2. The medical device according to claim 1, wherein the first link and the second link each include a pair of proximal-facing cams on the proximal surface of the respective annular ring.

3. The medical device according to claim 2, wherein each cam of the pair of proximal-facing cams is positioned circumferentially opposite to the proximal surface of the respective annular ring with respect to the longitudinal axis of the tool.

4. The medical device according to claim 2 or 3, wherein the first link and the second link further include a pair of distally facing cams on the distal surface of the respective annular ring.

5. The medical device according to claim 4, further comprising a plurality of links, wherein the pair of distally facing cams of each link are circumferentially aligned with the corresponding distally facing cams of adjacent links, and the pair of proximal facing cams are circumferentially aligned with the corresponding proximal facing cams of adjacent links.

6. The medical device according to claim 4 or 5, wherein each of the pair of distally facing cams is arranged circumferentially opposite to the distal surface of the annular ring.

7. The medical device according to any one of claims 4 to 6, wherein the proximal cam is offset by 90 degrees with respect to the distal cam.

8. The medical device according to claim 1, wherein the first link and the second link each further include a pair of pockets on the proximal surface of the respective annular ring and a pair of cams on the distal surface of the respective annular ring, the pair of cams having shapes corresponding to the pair of pockets.

9. The medical device according to claim 8, wherein the pair of pockets are concave and the pair of cams are convex.

10. The medical device according to claim 8 or 9, wherein the pair of pockets of the first link align with and receive the pair of cams of the second link.

11. The medical device according to any one of claims 8 to 10, wherein the pair of pockets on the proximal surface of each link are offset by 90 degrees with respect to the pair of cams on the distal surface.

12. The medical device according to claim 11, wherein the pair of pockets on the proximal surface of each link are circumferentially offset by 90 degrees relative to the pair of cams on the distal surface.

13. The medical device according to any one of claims 1 to 12, wherein the proximal and distal surfaces of the annular ring are configured to prevent rotational movement of the first link and the second link relative to each other.

14. The medical device according to claim 1, wherein the tool is configured to transition between a first linear configuration and a second bent configuration in response to the movement of the operating member.

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