Stable endoscope needle

The steerable needle with a flexible distal portion and channel-cable system addresses alignment issues in EUS procedures, enabling precise and controlled insertion into target tissue structures for procedures like stent placement and obstruction removal.

JP2026516435APending Publication Date: 2026-05-25BOSTON SCI MEDICAL DEVICE LTD
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
BOSTON SCI MEDICAL DEVICE LTD
Filing Date
2024-06-24
Publication Date
2026-05-25

AI Technical Summary

Technical Problem

In procedures guided by EUS, aligning an insertion device with the desired needle path to a target tissue structure is challenging, making it difficult to introduce a guide wire or perform stent placement or remove obstructions.

Method used

A steerable needle with a flexible distal portion and multiple channels for cables, allowing the distal portion to be curved in a predetermined plane using actuators and cables outside the body, enhancing alignment and insertion into target tissue structures.

Benefits of technology

Facilitates precise and controlled insertion of the needle into target tissue structures, improving the ability to perform procedures like stent placement and obstruction removal by allowing real-time adjustment of the needle's orientation.

✦ Generated by Eureka AI based on patent content.

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Abstract

A device comprising a needle, cables, and a handle. The needle has a proximal portion and a distal portion, the distal portion being more flexible than the proximal portion. The needle also comprises a plurality of channels extending within its walls, each of which extends from the proximal end of the needle to the distal channel end within the distal portion. The needle can be inserted into a living body via an insertion device. Each of the plurality of cables is received within a corresponding channel among the plurality of channels. The distal end of each of the plurality of cables is coupled to the distal channel end of the corresponding channel. The handle remains outside the body during use. The handle comprises an actuator coupled to the cable. By moving the actuator away from its neutral position, at least one of the plurality of cables is positioned under tension, causing the distal portion of the needle to bend.
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Description

Technical Field

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[0006] ,

[0001] The present disclosure relates to an endoscopic needle, particularly an endoscopic ultrasound (EUS) access needle.

Background Art

[0002] In procedures guided by EUS, a hollow needle may be used to access a target tissue structure (e.g., a bile duct) and to introduce a guide wire through the needle lumen into the target tissue structure, for example, to guide a stent placement procedure or to remove an obstruction. In certain procedures, it is impossible for the user to align an insertion device (e.g., an endoscope) with the desired needle path to the target tissue structure.

Summary of the Invention

[0003] The present disclosure relates to a device for treating tissue. The device includes a needle having a proximal portion and a distal portion. The distal portion is more flexible than the proximal portion. The needle further includes a plurality of channels extending within its wall. Each of the plurality of channels extends from the proximal end of the needle to a distal channel end within the distal portion. The needle is configured to be inserted into a living body via an insertion instrument.

[0004] The device also includes a plurality of cables. Each of the plurality of cables is received within a corresponding one of the plurality of channels. The distal end of each of the plurality of cables is coupled to the distal channel end of the corresponding channel.

[0005] In addition, the device includes a handle. During use, the handle remains located outside the body. The handle includes an actuator coupled to the plurality of cables. By operating the actuator to move away from a neutral position, at least one of the plurality of cables is placed in a tensioned state to curve the distal portion of the needle.

[0006] In one embodiment, the needle is hollow, and the plurality of channels extend along the length of the needle within the wall surrounding the lumen of the needle. In one embodiment, the plurality of channels extend to the distal end of the needle.

[0007] In one embodiment, the needle has a first channel pair on a first side surface of the needle and a second channel pair on a second side surface of the needle opposite to the first side surface, the device has a first cable pair passing through the first channel pair and a second cable pair passing through the second channel pair, the proximal ends of the plurality of cables of the first cable pair and the proximal ends of the plurality of cables of the second cable pair are connected to the actuator, tension is applied to the plurality of cables of the first cable pair and the plurality of cables of the second cable pair are loosened so that the distal portion of the needle curves toward the first side surface of the needle when the actuator is operated in a first direction.

[0008] In one embodiment, the plurality of cables are formed from nitinol and have a diameter of 0.1 mm to 0.2 mm. In one embodiment, the distal portion of the needle is provided with a plurality of notches in the wall of the needle, and the first portion of the plurality of notches is arranged in a first group extending along the first side surface of the distal portion of the needle.

[0009] In one embodiment, the second portion of the plurality of notches is arranged in a second group extending along the second side surface of the distal portion of the needle. In one embodiment, the plurality of notches in the first group are substantially similar to the plurality of notches in the second group in terms of size and distribution along the length of the distal portion of the needle.

[0010] In one embodiment, at least one of the spacing and size of the plurality of notches in the first group varies along the length of the first group. In one embodiment, at least one of the spacing and size of the plurality of notches in the second group varies along the length of the second group.

[0011] In one embodiment, the needle is configured such that the distal portion of the needle is bent only in a predetermined plane by the operation of the actuator. In addition, this disclosure relates to a device for treating tissue. The device comprises a needle having a flexible distal portion. The needle comprises a plurality of channels extending within its wall. Each of the plurality of channels extends from the proximal end of the needle to the distal channel end within the distal portion. The needle is configured to be inserted into a living body via an insertion device.

[0012] The device comprises a first cable received in a first channel among the plurality of channels, the distal end of the first cable being coupled to the distal channel end of the first channel. In addition, the device comprises a second cable received in a second channel among the plurality of channels, the distal end of the second cable being coupled to the distal channel end of the second channel. The second cable is located on a second side of the needle opposite to a first side of the needle where the first cable is located. The first and second cables extend to a position outside the patient's body that remains accessible to the user during use of the device, so that the user can apply tension to the first cable to curve the distal portion of the needle toward the first side.

[0013] In one embodiment, the device further comprises a handle that remains outside the body during use. The handle includes actuators coupled to the first cable and the second cable, the actuators configured to position the first cable in a state where tension is applied so that the distal portion of the needle is curved toward the first side surface of the needle by operating the actuator in a first direction away from a neutral position, and to position the second cable in a state where tension is applied so that the distal portion of the needle is curved toward the second side surface of the needle by operating the actuator in a second direction away from a neutral position.

[0014] In addition, the present disclosure relates to a method for treating tissue. This method includes inserting an insertion device to a target site in a living body; inserting a needle having a proximal portion and a distal portion (the distal portion being more flexible than the proximal portion) through the insertion device; extending the distal portion of the needle distally outside the insertion device to enter a target tissue structure; applying tension to at least one cable penetrating the wall of the needle to pull the needle into a curved shape within the target tissue structure to achieve a desired orientation; and positioning the needle within the target tissue structure.

[0015] In one embodiment, the method further includes manipulating a handle to orient the needle such that the plane on which the distal portion of the needle curves is in a desired orientation with respect to the target tissue structure before tension is applied to the at least one cable.

[0016] In one embodiment, the target tissue structure is a bile duct. The method further includes positioning the entire distal portion within the bile duct. In one embodiment, the distal portion of the needle is provided with a plurality of notches in the wall of the needle, the first portion of the plurality of notches is arranged in a first group extending along a first side surface on the distal portion of the needle, and the invention further includes supplying fluid into the lumen of the needle and supplying this fluid to the bile duct through the plurality of notches in the first group.

[0017] In one embodiment, the second portion of the plurality of notches is arranged in a second group extending along a second side surface on the distal portion of the needle, and the plane on which the distal portion of the needle curves extends through the midpoints of the plurality of notches in the first and second groups.

[0018] In one embodiment, tension is applied to the at least one cable by operating an actuator on a handle connected to the needle. In one embodiment, the actuator includes a ball joint between the two parts of the handle. [Brief explanation of the drawing]

[0019] [Figure 1] Figure 1 shows a perspective view of a steerable needle device according to a first embodiment, the needle being in the first form. [Figure 2] Figure 2 shows a perspective view of the apparatus described in Figure 1, in which the needle extends distally from the distal end of the protective sheath in the second embodiment. [Figure 3] Figure 3 shows a perspective view of the apparatus described in Figure 1, in which the needle extends distally from the distal end of the protective sheath in the third embodiment. [Figure 4A] Figure 4A shows a perspective view of the distal portion of the needle of the device described in Figure 1. [Figure 4B] Figure 4B shows a perspective view of the distal end of the needle described in Figure 4A. [Figure 5] Figure 5 shows a perspective view of the steering coupling of the device described in Figure 1.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The present disclosure may be further understood with reference to the following description and the accompanying drawings, in which like elements are denoted by the same reference numerals. Exemplary embodiments describe a steerable needle device that facilitates insertion of the needle into a target tissue structure.

[0021] In the present application, the terms distal and proximal refer to the direction away from (distal) and towards (proximal) the user of the device. Thus, for a device according to the described embodiments used in combination with an insertion device (e.g., an endoscope), the proximal end of the device remains accessible to its user outside the body, while the distal end is inserted through the insertion device (e.g., into the working channel of the insertion device) and extends distally beyond the distal end of the insertion device to the target tissue structure. Devices according to various embodiments are described as being used in combination with a flexible endoscope for accessing the bile duct, but one of ordinary skill in the art will understand that such devices can be widely used in combination with various flexible or rigid insertion devices (e.g., ureteroscopes, lithotripters, laparoscopes, etc.) to facilitate needle insertion into any desired tissue structure. As will be understood by one of ordinary skill in the art, needles according to the embodiments disclosed herein are typically formed from a single material (e.g., nitinol) along their length and have tissue-penetrating tips at their distal ends. As will be further understood by one of ordinary skill in the art, nitinol improves the column strength of the needle and facilitates pushing the needle through the insertion device even when the insertion device defines a serpentine path. This material also improves the transmission of torque along the needle, thereby facilitating steering of the laser-cut flexible distal portion while improving the rigidity of the proximal portion of the needle. Thus, a steerable needle as described herein may have a small diameter of about 0.3 mm.

[0022] As shown in FIGS. 1-5, the apparatus 100 according to an exemplary embodiment includes a handle 102 that extends to a distal end 104, and the distal end 104 includes a coupling portion 106 configured to be coupled to the proximal end of an insertion device. For example, in this embodiment, the coupling portion 106 is configured to thread into a corresponding coupling portion at the proximal end (not shown) of the insertion device. As described in more detail below, the coupling portion 106 of this embodiment is configured to rotate the handle 102 relative to the coupling portion 106 without loosening or tightening the connection between the handle 102 and the insertion device by rotating the distal end 104 of the handle 102 relative to the coupling portion 106. The handle 102 of this embodiment includes a proximal portion 105 coupled to a distal portion 107 at a joint 109.

[0023] The apparatus 100 of this embodiment includes an insertion portion 108 that extends distally from the handle 102, and the insertion portion 108 is configured to be slidably inserted into the insertion device. In this embodiment, since the apparatus 100 is configured for use in combination with a flexible insertion device (e.g., a flexible endoscope), the insertion portion 108 is flexible enough to be inserted through the insertion device even when the insertion device is inserted into a target site in a living body along a serpentine path (e.g., a path defined by a natural body cavity into which the insertion device is inserted through a natural body pore), and when the coupling portion 106 is connected to the proximal end of the insertion device, the distal end 110 of the insertion portion 108 is at a desired distance (e.g., the distance from the distal end of the insertion device when the distal end of the insertion device is at a target position adjacent to the position where the insertion portion 108 accesses the target tissue structure, and the distance by which the distal end 110 of the insertion portion 108 extends into the target tissue structure) and has a length selected to extend distally beyond the distal end of the insertion device.

[0024] In addition, the handle 102 is equipped with an insertion port 111 that is in fluid communication with the central lumen 120 of the needle 112, and the fluid introduced into the insertion port 111 is supplied to the tissue surrounding the distal portion 114 of the needle 112. The needle 112 may be formed from a biocompatible metal such as nitinol (e.g., nitinol hypotube) or stainless steel, or from a plastic such as PEEK or Delrin.

[0025] The handle 102 further comprises a length adjustment mechanism 103 having a slider 117 attached to the proximal portion 105 by a locking nut 119, the locking nut 119 being loosened to allow the slider to slide longitudinally beyond the proximal portion 105 to a desired position so that the length of the needle 112 can be adjusted relative to the length of the insertion device, and the needle 112 of the desired length is extended distally from the insertion device when the connecting portion 106 is coupled to the insertion device as needed.

[0026] As shown in Figures 4A and 4B, the flexible distal portion 114 of the needle 112 extends distally from the less flexible proximal portion 116 of the needle 112 to the distal end 115. The needle 112 in this embodiment has an outer wall 118 surrounding and defining a central lumen 120, which is configured, for example, for introducing therapeutic fluid into a target tissue structure or for removing fluid or other substances from a target tissue structure. Multiple cable lumens 122 (four cable lumens 122 in this embodiment) penetrate the wall 118 of the needle 112, with each of the multiple cable lumens 122 extending from a proximal end adjacent to the joint 109 to a distal end adjacent to the distal end 115 of the needle 112.

[0027] The needle 112 is equipped with a plurality of steering cables 124. Each of the cables 124 is fixed to the wall 118 of the needle 112 at its distal end 115 and extends through the corresponding cable lumen of a plurality of cable tubules 122 to a proximal end 125 connected to a joint 109, as will be described in more detail below. Specifically, the cables 124 are configured such that when the cables 124 of the first pair 124a are pulled proximal and the cables 124 of the second pair 124b are extended further distally, the tension applied to one side of the needle 112 causes the needle 112 to bend toward the side of the needle 112 through which the cables 124 of the first pair 124a pass. In other words, the distal end 115 of the needle 112 is deflected away from the longitudinal axis L of the needle 112 such that the distal portion 114 of the needle 112 forms an arc with a bending radius that progressively decreases as the amount drawn proximal to the plurality of cables 124 of the first pair 124a increases.

[0028] Those skilled in the art will understand that the extent to which the curvature applied to the needle 112 continues until it connects to the proximal portion 116 of the needle 112 depends (as will be described in more detail below) on the relative flexibility of the proximal portion 116 and the distal portion 114, as well as the length to which the needle 112 extends distally beyond the distal end of the insertion device. Those skilled in the art will understand that the multiple cables 124 can be formed from, for example, nitinol. This makes it possible to use multiple cables 124 with cross-sectional diameters of 0.1 mm to 0.2 mm to deliver the tensile force required to bend the needle 112 over a length of 1 mm to 4.5 mm. This small diameter may be required, for example, when the wall 118 of the needle 112 is 0.01 inches (0.254 mm) to 0.03 inches (0.762 mm) thick.

[0029] As shown in Figure 4A, the flexibility of the distal portion 114 of the needle 112 is improved by providing the distal portion 114 with a plurality of notches 126 in the wall 118 distributed along the length of the distal portion 114. In this embodiment, the plurality of notches 126 are distributed in two separate longitudinal groups. The first group 126a in this embodiment extends along the first side surface of the needle 112 corresponding to a plurality of paths in a plurality of lumens 122 through which a first pair 124a of a plurality of cables 124 passes, while the second group 126b extends along the second side surface of the needle 112 (opposite the first side surface) corresponding to a plurality of paths in a plurality of lumens 122 through which a second pair 124b of a plurality of cables 124 passes.

[0030] The multiple notches 126 in this embodiment are shown to be sized substantially equally from one another along the length of the distal portion 114 and spaced apart, with the circumferential lengths of each of the multiple notches 126 in the first group 126a being substantially equal to each other, and similarly substantially equal to the circumferential lengths of each of the multiple notches 126 in the second group 126b. However, those skilled in the art will understand that the spacing, width (along the axis L), or circumferential length of the multiple notches 126, or any or all of them, can be varied along the length of the distal portion 114, and can be varied between the first group 126a and the second group 126b, and that the length of the distal portion 114 can be varied to achieve a desired bend of the needle 112.

[0031] For example, the distal portion of the distal portion 114 (e.g., the most distal 60% to 80% of the total length of the distal portion 114) may be made to be more flexible than the proximal portion of the distal portion 114. This can be achieved, as can be understood by those skilled in the art, by increasing the number of cuts per unit length by increasing one or both of the width and circumference of the multiple cuts 126, or by reducing the thickness of the wall 118 in the flexible portion of the distal portion 114.

[0032] Furthermore, as will be understood by those skilled in the art, the distribution of the multiple notches 126 in this embodiment is configured to bend the distal portion 114 of the needle 112 in a pre-selected plane. For example, the distal portion 114 in this embodiment is configured to bend (based on the operation of the multiple cables 124) in a plane P passing through the midpoint M between the multiple cable lumens 122 of the multiple cables 124 of the first pair 124a and the multiple cable lumens 122 of the multiple cables 124 of the second pair 124b. Furthermore, those skilled in the art will understand that the multiple notches 126 enhance the visibility of the distal portion 114 of the needle 112 under ultrasound, as the edges of the multiple notches 126 enhance the reflection of ultrasonic energy.

[0033] As previously shown, the proximal ends 125 of the multiple cables 124 are connected to a joint 109, thereby allowing the user to apply tension to either the multiple cables 124 of a first pair 124a or the multiple cables 124 of a second pair 124b by manipulating the proximal portion 105 of the handle 102 relative to the distal portion 107, in order to bend the distal portion 114 of the needle 112 in a desired direction in plane P. Specifically, the joint 109 includes a ball 130 formed at the distal end of the proximal portion 105, the ball 130 being rotatably received in a correspondingly shaped recess 132 formed at the proximal end of the distal portion 107.

[0034] As can be understood by those skilled in the art, in this embodiment, the joint 109 is formed so that the ball 130 can rotate in the recess 132 only in a plane corresponding to the distribution of points where the plurality of cables 124 of the first pair 124a are coupled to the ball 130 and where the plurality of cables 124 of the second pair 124b are coupled to the ball 130. More specifically, the proximal portion of each of the plurality of cables 124 passes through the ball 130, and the crimps 136 at the respective proximal ends of the plurality of cables 124 prevent the proximal ends of the plurality of cables 124 from being pulled distally through the ball 130. Therefore, when the proximal portion 105 of the handle 102 is rotated relative to the distal portion 107, one of the plurality of cables 124 of the first pair 124a and the second pair 124b is tensed or pulled out proximally through the needle 112, and the plurality of cables 124 of the other pair are correspondingly loosened so that the distal end of the needle 112 is pulled toward the side of the needle 112 containing the tensed pair of plurality of cables 124.

[0035] In other words, the joint 109 of this embodiment is designed so that the user can apply tension to only one of the first pair 124a or the second pair 124b of the plurality of cables 124, and cannot, for example, apply tension to the first cable of the plurality of cables 124 of the first pair 124a and the first cable of the plurality of cables 124 of the second pair 124b simultaneously. This ensures that the distal portion 114 of the needle 112 is bent only in plane P. However, since the distal portion 107 of the handle 102 is rotatable relative to the coupling 106 (and consequently relative to the insertion device coupled thereto), the distal portion 114 of the needle 112 can be deflected in any desired plane by rotating the distal portion 107 relative to the insertion device, and consequently rotating the needle 112 relative to the insertion device. In other words, the needle 112 in this embodiment is fixed to the distal portion 107 of the handle 102 so as to rotate the needle 112 by rotating the distal portion 107 of the handle 102, and then rotate the plane P (i.e., relative to the target tissue structure) within the body.

[0036] For example, as shown in Figure 2, the proximal portion 105 is rotated in a first direction A, thereby applying tension to the multiple cables 124 of the first pair 124a and curving the distal end 115 of the needle 112 toward the side surface of the needle 112 including the multiple notches 126 of the first group 126a. On the other hand, as shown in Figure 3, the proximal portion 105 is rotated in a second direction B, thereby applying tension to the multiple cables 124 of the second pair 124b and curving the distal end 115 of the needle 112 toward the side surface of the needle 112 including the multiple notches 126 of the second group 126b. Those skilled in the art will understand that the further the proximal portion 105 is rotated relative to the distal portion 107 (for example, from a neutral position where the longitudinal axis of the proximal portion 105 is aligned with the longitudinal axis of the distal portion 107), the more the distal portion 114 of the needle 112 will bend more tightly (i.e., the bending radius of the curved distal portion 114 will decrease).

[0037] When in use, the user can first adjust the position of the length adjustment mechanism 103 on the proximal portion 105 of the handle 102 to the insertion position (e.g., insertion / storage configuration), in which case the length of the needle 112 is selected such that the distal end 115 of the needle 112 remains within the working channel of the insertion device (e.g., so that the needle 112 does not protrude from the insertion device when the insertion device is inserted into a target location in the body). The user then inserts the needle 112 through the working channel of the insertion device (e.g., an endoscope) and connects the coupling portion 106 to the corresponding coupling portion on the proximal end of the insertion device.

[0038] The insertion device, which then houses the needle 112, is inserted into the body (through natural orifices and through natural columens) to a target site adjacent to an adjacent portion of the tissue structure accessed by the needle. The user then readjusts the position of the length adjustment mechanism 103 (for example, to an operable configuration defined based on the length of the insertion device being used) so that the needle 112 of a desired length (for example, having at least a distal portion 114) sufficient to pass the needle 112 to the target tissue structure protrudes as desired from the distal end of the insertion device. Those skilled in the art will understand that, if desired, the needle 112 may be inserted into the working channel of the insertion device and coupled thereafter the distal end of the insertion device has been positioned as desired relative to the target tissue structure.

[0039] In this case, the length adjustment mechanism 103 may simply be set to the operable form, and the connecting portion 106 may then be connected to the insertion device. The user may use the steering function (if any) of the insertion device and the operation of the proximal portion 105 relative to the distal portion 107 of the handle 102 to curve the distal portion 114 of the needle 112 to any desired curvature that may be useful when inserting the needle 112 into the target tissue structure. As will be understood by those skilled in the art, curving the needle 112 may be useful if the user loses access to the target tissue structure during the procedure. For example, if the needle 112 slips out of the bile duct, the user may, as desired, curve the distal portion 114 of the needle 112 to facilitate reinsertion of the needle 112 into the bile duct.

[0040] Needle 112 can be inserted into the target tissue structure in the same manner as can be performed with conventional needles. For example, if the target tissue structure is the bile duct, the user can insert the insertion device to the target location in the small intestine using the visual system of the insertion device, in addition to ultrasound imaging, and advance the distal end 115 of needle 112 (which may include a tissue-penetrating tip) distally out of the insertion device until the distal end 115 of needle 112 penetrates the target site in the small intestinal wall, then penetrates the bile duct wall, and enters the bile duct. At this point, the distal end 115 of needle 112 is no longer visible using the endoscopic visual system, so the user can use ultrasound imaging to curve the distal portion of needle 112 as desired by moving the proximal portion 105 relative to the distal portion 107 in either direction A or B.

[0041] For example, if the user wants to point the distal end 115 of the needle 112 upstream into the bile duct, based on observation of the multiple notches 126, the user first rotates the handle 102 around the longitudinal axis of the distal portion 107 in direction C as shown in Figure 3 relative to the insertion device until the plane P is aligned so that it normally includes the longitudinal axis of the bile duct. Alternatively, the user can adjust the rotation of the distal portion 107 by slightly curving the distal portion 114 until the curvature of the distal portion 114 aligns with the axis of the bile duct. Once the user has curved the distal portion 114 as desired, the user can further extend the needle 112 distally so that the curved distal portion advances into the bile duct in the desired direction. Once the needle 112 is positioned as desired, the user can perform any other desired procedure in the same manner as it would be performed with a conventional needle.

[0042] For example, the user can pass a guidewire through the insertion port 111 and advance it into the bile duct via the needle, thereby allowing other devices to be inserted into the bile duct along the guidewire. Furthermore, the lengths of the first group 126a and the second group 126b are selected so that all of the multiple notches 126 are within the bile duct (or other target tissue structure) when the needle 112 is positioned as desired. Thus, the fluid supplied to the needle 112 via the insertion port 111 travels through the entire proximal portion 116, which has no openings through the wall 118, until it reaches the multiple notches 126 and flows out into the bile duct. Finally, a person skilled in the art will recognize that the user can curve the distal portion 114 to any desired degree by controlling the amount of deflection of the proximal portion 105 relative to the distal portion 107, thereby allowing for more control of the curvature angle than could be achieved by, for example, a needle with a pre-formed J-shaped tip.

[0043] Once the procedure is complete, the user may detach the connecting portion 106 from the insertion device and withdraw the needle 112 entirely from the insertion device (for example, moving the guidewire away from its position), so that the working channel of the insertion device can then be used to insert other devices into the bile duct on the guidewire. Alternatively, the user may simply adjust the length adjustment mechanism 103 so that the needle 112 is returned to an inserted / storage configuration in which it is fully housed within the insertion device. The insertion device can then be withdrawn from the body along the needle 112.

[0044] It will be apparent to those skilled in the art that various modifications can be made to this disclosure without departing from the scope of the disclosure. Furthermore, those skilled in the art will understand that any form of the various embodiments can be combined in any way that does not contradict the descriptions and / or functions of the multiple embodiments. For example, those skilled in the art will understand that any number of cables (two or more) can be used to achieve a desired curvature of the distal portion of the needle. Furthermore, any of the widely known mechanisms, including those on a handle slider or knob that winds up or unwinds multiple cables when rotated, can be used to apply tension to one or more cables, and such mechanisms can be employed in any desired way that facilitates the curvature of the distal portion of the needle by the user.

Claims

1. A device for treating tissue, A needle having a proximal portion and a distal portion that is more flexible than the proximal portion, the needle further comprising a plurality of channels extending within its wall, each of the plurality of channels extending from the proximal end of the needle to the distal channel end in the distal portion, and the needle being configured to be inserted into a living body via an insertion device, A plurality of cables, each of which is received within a corresponding channel among the plurality of channels, and the distal end of each of the plurality of cables is coupled to the distal channel end of the corresponding channel, A device comprising a handle that remains positioned outside the living body during use, and which is equipped with an actuator connected to the plurality of cables, wherein the handle is operated to move the actuator away from the neutral position, thereby tensing at least one of the plurality of cables so that the distal portion of the needle is curved.

2. The apparatus according to claim 1, wherein the needle is hollow, and the plurality of channels extend over the length of the needle in the wall surrounding the lumen of the needle.

3. The apparatus according to claim 2, wherein the plurality of channels extend to the distal end of the needle.

4. The device according to any one of claims 1 to 3, wherein the needle has a first channel pair on a first side surface of the needle and a second channel pair on a second side surface of the needle opposite to the first side surface, the device comprises a first cable pair passing through the first channel pair and a second cable pair passing through the second channel pair, the proximal ends of the plurality of cables of the first cable pair and the proximal ends of the plurality of cables of the second cable pair are connected to the actuator, tension is applied to the plurality of cables of the first cable pair and the plurality of cables of the second cable pair are loosened when the actuator is operated in a first direction such that the distal portion of the needle curves toward the first side surface of the needle.

5. The apparatus according to any one of claims 1 to 4, wherein the plurality of cables are formed from nitinol and have a diameter of 0.1 mm to 0.2 mm.

6. The apparatus according to claim 4, wherein the distal portion of the needle is provided with a plurality of notches in the wall of the needle, and the first portion of the plurality of notches is arranged in a first group extending along the first side surface on the distal portion of the needle.

7. The apparatus according to claim 6, wherein the second portion of the plurality of notches is arranged in a second group extending along the second side surface on the distal portion of the needle.

8. The apparatus according to claim 7, wherein the plurality of notches of the first group are substantially similar to the plurality of notches of the second group in terms of size and distribution along the length of the distal portion of the needle.

9. The apparatus according to claim 7, wherein at least one of the spacing and size of the plurality of notches in the first group changes along the length of the first group.

10. The apparatus according to claim 9, wherein at least one of the spacing and size of the plurality of notches in the second group changes along the length of the second group.

11. The apparatus according to any one of claims 1 to 10, wherein the needle is configured such that the distal portion of the needle is bent only in a predetermined plane by the operation of the actuator.

12. A device for treating tissue, A needle having a flexible distal portion, wherein the needle comprises a plurality of channels extending within its wall, each of which extends from the proximal end of the needle to the distal channel end within the distal portion, and the needle is configured to be inserted into a living body via an insertion device, A first cable received within a first channel among the plurality of channels, wherein the distal end of the first cable is coupled to the distal channel end of the first channel, A second cable received within a second channel among the plurality of channels, the distal end of the second cable being coupled to the distal channel end of the second channel, and the second cable comprising a second cable positioned on a second side of the needle opposite to a first side of the needle in which the first cable is positioned, The first cable and the second cable extend to a position outside the patient's body during use of the device that remains accessible to the user, so that the user can apply tension to the first cable to curve the distal portion of the needle toward the first side.

13. The apparatus according to claim 12, further comprising a handle that remains positioned outside the living body during use, the handle comprising actuators coupled to the first cable and the second cable, wherein the actuators are configured such that by operating the actuator in a first direction away from a neutral position, the first cable is positioned in a state in which tension is applied so as to bend the distal portion of the needle toward the first side surface of the needle, and by operating the actuator in a second direction away from a neutral position, the second cable is positioned in a state in which tension is applied so as to bend the distal portion of the needle toward the second side surface of the needle.