Systems and methods for curved needles

Abstract

A needle bending assembly configured to at least temporarily receive a needle may include a first housing section, a second housing section, and a coupling element coupled between the first housing section and the second housing section. The first housing section defines a first cavity configured to at least temporarily receive the first section of the needle. The second housing section defines a second lumen configured to at least temporarily receive a second section of a needle forming a distal tip. The coupling element is configured such that movement of the second housing section relative to the first housing section causes the needle to bend at a position corresponding to the coupling element when the needle is received within the housing section.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 345,255, filed on May 24, 2022, entitled “Systems and Methods for Bending a Needle,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to systems and methods for bending needles. More specifically, the present disclosure relates to systems and methods for bending needles such as spinal puncture needles and biopsy needles, which in some cases may include an indwelling stylet. Background Art

[0004] Certain therapeutic and diagnostic medical procedures involve the use of long spinal needles that are bent near their tip by the physician shortly before the interventional procedure to facilitate steering toward the intended target. These procedures, which are typically performed using radiographic guidance (e.g., intermittent fluoroscopy), often involve maneuvering around bones and other important structures to reach their intended target. In typical practice, the physician will use a needle driver (a surgical instrument designed to grasp a surgical needle) to clamp the end of the spinal needle and then introduce a slight bend (e.g., in the order of about 5 degrees) in the tip.

[0005] Alternatively, physicians sometimes bend the needle using only their gloved hands, which can result in loss of sterility due to inadvertent puncture of their gloves and the risk of needle stick injuries. Another unsatisfactory method of bending surgical needle tips involves the use of a needle cover or cap, loosely applied to the distal needle tip, to bend the needle tip under rough control.

[0006] Challenges faced by some known techniques for manually bending needle tips may include, for example: a) imprecision and / or non-reproducibility of the bend; b) the "off-axis" nature of the bend, since the bend may inadvertently occur in two axes, given the way the needle driver grips the needle tip; c) risk of accidental needle stick injuries to the physician as the needle is manipulated during the bending process; d) risk of damage to the needle itself (such as cutting surfaces of the needle bevel or tip) or compression of the interior lumen of the needle; e) cost of additional surgical tools, cleaning and sterilization cycles per procedure; f) loss of physician and support staff time, etc. In addition, the forces associated with bending a needle containing a stylet may exceed those achievable by using finger pressure alone.

[0007] To alleviate these or other challenges, some known needles may be pre-bent and / or otherwise manufactured to include a bend. However, such known needles are substantially more expensive and do not provide the option of performing the procedure with a straight needle tip.

[0008] Some known needle bending systems attempt to address the above challenges, such as, for example, those described in U.S. Patent No. 11,014,141, filed on September 29, 2022, entitled "Needle Bending Assembly," the disclosure of which is incorporated herein by reference in its entirety. However, there is a need for an apparatus, system, and / or method for bending a needle such as a spinal puncture needle, a biopsy needle, etc. Furthermore, there is a need to include such an apparatus and / or system into the sterile packaging of the needle. Summary of the invention

[0009] The present disclosure provides systems and methods for bending needles such as spinal puncture needles and / or biopsy needles. According to the disclosed embodiments, a needle bending assembly configured to at least temporarily accommodate a needle may include a first housing segment, a second housing segment, and a coupling element connected between the first housing segment and the second housing segment. The first housing segment defines a first cavity that is configured to at least temporarily accommodate a first segment of the needle. The second housing segment defines a second cavity that is configured to at least temporarily accommodate a second segment of the needle that forms a distal tip. The coupling element is configured such that when the needle is accommodated within the housing, movement of the second housing segment relative to the first housing segment causes the needle to bend at a position corresponding to the coupling element. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The skilled artisan will appreciate that the drawings are primarily for illustrative purposes and are not intended to limit the scope of the subject matter described herein. The drawings are not necessarily drawn to scale; in some cases, various aspects of the subject matter disclosed herein may be exaggerated or enlarged in the drawings to facilitate understanding of different features. In the drawings, like reference numerals generally refer to similar features (e.g., functionally similar and / or structurally similar elements).

[0011] Figure 1A is a schematic diagram of a needle bending system for bending a needle according to an embodiment.

[0012] Figure 1B yes Figure 1A A schematic diagram of a needle bending system is shown with a needle placed within the needle bending assembly.

[0013] Figure 1C yes Figure 1A and Figure 1B Schematic diagram of a needle bending system shown having a first housing segment and a second housing segment, wherein the second housing segment rotates relative to the first housing segment.

[0014] Figure 2-6 are various views of a needle bending system in a first configuration according to an embodiment, wherein a needle is disposed in an unbent state in a needle bending assembly.

[0015] Figure 7-12 It is in the second structure Figure 2 Various views of a needle bending system in which a needle bending assembly has been manipulated to bend a needle disposed therein.

[0016] Figure 13-18 It is in the third structure Figure 2 Various views of a needle bending system and showing a bent needle being withdrawn from the needle bending assembly.

[0017] Fig.19 is a schematic diagram of at least a portion of a needle bending system in a first configuration according to an embodiment.

[0018] Figure 20-24 is shown in the second configuration Fig.19 Various views of one or more portions of a needle bending system.

[0019] Fig.25 and Fig.26 is a schematic diagram of a portion of a needle bending system according to an embodiment.

[0020] Fig. 27 and Fig.28 Schematic side view and schematic top view, respectively, of a portion of a needle bending system according to an embodiment.

[0021] Fig.29 and Fig.30 is a schematic side view of a portion of a needle bending system, each according to an embodiment.

[0022] Fig.31 and Fig.32 2 are front and rear perspective views, respectively, of a needle bending system showing a needle assembly removably coupled to a needle bending assembly according to an embodiment.

[0023] Fig.33 Is Fig.32 A magnified view of a portion of the needle bending system identified by the circled area.

[0024] Fig.34 yes Fig.31 An enlarged cross-sectional view of a portion of a needle bending system showing the needle hub disengaged from the proximal portion of the needle bending assembly.

[0025] Fig.35 yes Fig.31An enlarged cross-sectional view of a portion of a needle bending system showing a needle hub engaged with a proximal portion of a needle bending assembly.

[0026] Fig.36 is a flow chart illustrating a method of bending a needle using a needle bending system according to an embodiment. DETAILED DESCRIPTION

[0027] Various aspects of the present disclosure relate to systems and methods for bending needles with or without an indwelling stylet, such as spinal puncture needles and / or biopsy needles. The following detailed description should not be construed as limiting, but is merely intended to illustrate the general principles of the invention. In some cases, a system for bending a needle (needle bending system) may include a needle bending assembly and a needle. In some cases, the needle bending system may be prepackaged and sterilized and include a straight needle placed in a housing or shell of the needle bending assembly for bending. In this case, as described in detail herein with respect to specific embodiments, an end user such as a physician, doctor, surgeon, nurse practitioner, nurse anesthetist, operating room technician, scrub nurse, etc. may manipulate the needle bending system to impart a desired bend in the needle.

[0028] The embodiments described herein can be used to bend needles of any suitable type or size. Although specific examples can be described, it should be understood that such examples are not intended to be limiting in any way. In some embodiments, for example, the embodiments described herein can be used to bend spinal puncture needles. Generally, these needles are configured to be inserted into the spine (and other body tissues) at a predetermined angle, usually with the assistance of intermittent fluorescent guidance, so as to turn the tip of the needle to the desired target. In some embodiments, such spinal puncture needles may include a retention stylet or wire that fills or substantially fills the inner diameter of the spinal puncture needle during insertion into the body to prevent tissue or fluid from traveling through the lumen of the needle. Once the tip of the needle is in the desired position, the stylet can be removed and (multiple) fluids can be injected into the body and / or removed from the body. Any of the embodiments described herein can be used to bend such needles to a desired and / or predetermined angle before insertion, with or without a stylet provided in the lumen. However, in other embodiments, any of the embodiments described herein can be used to bend needles of any suitable type or size for any suitable procedure and / or purpose. For example, in some embodiments, any of the embodiments described herein can be used to bend needles intended for use in procedures performed on human patients, while in other embodiments, any of the embodiments can be used to bend needles intended for use in procedures performed on animals or non-human patients. Additionally, in some embodiments, the embodiments described herein can be used to bend devices and / or components other than needles.

[0029] In some embodiments, the needle bending assembly may include a housing configured to at least temporarily accommodate the needle. The housing has a first housing segment, a second housing segment, and a coupling element. The first housing segment defines a first cavity configured to at least temporarily accommodate the first segment of the needle. The second housing segment defines a second cavity configured to at least temporarily accommodate the second segment of the needle forming the distal tip. The coupling element is configured to couple the first housing segment and the second housing segment so that when the needle is accommodated in the housing, movement of the second housing segment relative to the first housing segment causes the needle to bend at a position corresponding to the coupling element.

[0030] In some embodiments, a needle bending assembly configured to at least temporarily accommodate a needle may include a first housing segment, a second housing segment, and a coupling element coupled between the first housing segment and the second housing segment. The first housing segment defines a first cavity configured to at least temporarily accommodate a first segment of the needle. The second housing segment defines a second cavity configured to at least temporarily accommodate a second segment of the needle forming a distal tip. The coupling element is configured such that when the needle is accommodated within the housing, movement of the second housing segment relative to the first housing segment causes the needle to bend at a position corresponding to the coupling element.

[0031] In some embodiments, the needle bending system includes a needle assembly and a needle bending assembly. The needle assembly has a needle extending from a needle hub in a distal direction. The needle bending assembly is removably coupled to the needle assembly. The needle bending assembly includes: a first housing segment, the first housing segment defining a first cavity that removably accommodates a first segment of the needle; a second housing segment, the second housing segment defining a second cavity that removably accommodates a second segment of the needle forming its distal tip; and a coupling element, the coupling element being configured to couple the first housing segment and the second housing segment. The needle bending assembly is configured such that movement of the second housing segment relative to the first housing segment causes the needle to bend at a position corresponding to the coupling element.

[0032] In some embodiments, a needle bending assembly includes a first housing segment, a second housing segment, and a coupling element coupling the first housing segment to the second housing segment. In some embodiments, a method of bending a needle using a needle bending assembly includes transitioning the second housing segment from a first configuration to a second configuration relative to the first housing segment. The segments of the needle between the housing segments are engaged by the coupling element as a result of the transition, and the needle is bent as a result of the coupling element engaging the segments of the needle. After bending, the second housing segment is allowed to transition from the second configuration toward the first configuration. The method then includes withdrawing the bent needle from each of the first housing segment and the second housing segment.

[0033] As used in this specification and the appended claims, the singular articles "a," "an," and "the" should be understood to mean "at least one," unless explicitly stated to the contrary.

[0034] As used in this specification and the appended claims, the term "and / or" should be understood to include any and all combinations of one or more of the elements so combined (e.g., elements that exist jointly in some cases and separately in other cases). In addition to the elements explicitly identified in the "and / or" clause, other elements may optionally be present, whether related or unrelated to those elements explicitly identified. Thus, as a non-limiting example, when used in conjunction with open language (such as "comprising"), a reference to "A and / or B" may refer to only A (optionally including elements other than B) in one embodiment; to only B (optionally including elements other than A) in another embodiment; to both A and B (optionally including other elements) in yet another embodiment; and so on.

[0035] As used in this specification and the appended claims, "or" should be understood to have the same meaning as "and / or" defined above. For example, when separating items in a list, "or" or "and / or" should be interpreted as inclusive (e.g., including at least one, but also including many elements or more than one element in a list of elements, as well as optional additional unlisted items). Only terms that clearly indicate the opposite meaning (such as "only one", "exactly one", etc.) refer to including many elements or exactly one element in a list of elements. In general, the term "or" as used herein should only be interpreted as indicating exclusive alternatives (e.g., "one or the other but not both") when used in conjunction with exclusive aspects (such as "any one", "one of which", "only one of which", "exactly one of which", etc.).

[0036] As used in this specification and the appended claims, the phrase "at least one" referring to a list of one or more elements should be understood to mean at least one element selected from any one or more elements in the list of elements, but not necessarily including at least one element of each element specifically listed in the list of elements and not excluding any combination of elements in the list of elements. This definition also allows that in addition to the elements specifically identified in the list of elements to which the phrase "at least one" refers, elements may optionally be present, whether related to or unrelated to those specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or equivalently, "at least one of A or B", or equivalently, "at least one of A and / or B") may refer to at least one A, optionally including more than one A, without B (and optionally including elements other than B) in one embodiment; to at least one B, optionally including more than one B, without A (and optionally including elements other than A) in another embodiment; to at least one A, optionally including more than one A, and at least one B, optionally including more than one B (and optionally including other elements) in yet another embodiment; and so on.

[0037] As used in this specification and the appended claims, when used in conjunction with (multiple) stated values ​​and / or (multiple) geometric structures or (multiple) relationships, the terms "about", "approximately" and / or "substantially" are intended to convey that the value or characteristic so defined is nominally the stated value or described characteristic. In some cases, the terms "about", "approximately" and / or "substantially" may mean and / or generally consider the value or characteristic stated within a desired tolerance. For example, such a tolerance may be plus or minus 10% of the stated value (e.g., about 0.01 may include 0.009 to 0.011, about 0.5 may include 0.45 to 0.55, and about 10 may include 9 to 11). Similarly, two or more objects may be described as having substantially equal dimensions when the dimensions of the objects are nominally equal or within equal tolerances. Although the stated values, structures and / or relationships may be desired, it should be understood that some differences may occur due to, for example, manufacturing tolerances or other practical considerations (e.g., applied pressure, force, temperature, etc.). Therefore, the terms "about," "approximately," and / or "substantially" may be used herein to account for such tolerances and / or considerations.

[0038] Now referring to the accompanying drawings, Figures 1A-1C An exemplary embodiment of a needle bending system 100 is shown in FIG. The needle bending system 100 includes a needle bending assembly 102 and a needle 101 (which can be placed in the needle bending assembly 102, such as Figure 1B). Needle bending assembly 102 includes a first housing segment 111 and a second housing segment 131 coupled to first housing segment 111 via a coupling element 121. In some embodiments, as described in further detail herein, needle bending assembly 102 can be a one-piece (e.g., monolithic) disposable device that can be manipulated to bend a needle disposed within needle bending assembly 102. In such embodiments, coupling element 121 can be, form and / or include a living hinge or the like.

[0039] Figure 1A and Figure 1B 1 shows a schematic cross-sectional side view of the needle bending system 100. The first housing segment 111 and / or the second housing segment 131 (collectively referred to herein as "housing segments 111, 131") can have any suitable three-dimensional shape. Figure 1A As shown in , the cross-section of housing segments 111 and / or 131 can be substantially cylindrical, elliptical, polygonal, etc., with the corresponding first cavity 113 and / or second cavity 133 (collectively referred to as "cavities 113, 133" herein) extending therethrough in a direction along the longitudinal axis 103 of the needle bending assembly 102. Housing segments 111 and 131 can have substantially the same cross-sectional shape, or can have different or varying cross-sectional shapes. Similarly, the inner wall of each of housing segments 111 and 131 can define cavities 113 and 133, respectively, so that cavities 113 and 133 have any suitable cross-sectional shape. Cavities 113 and 133 can have substantially the same cross-sectional shape or can have different cross-sectional shapes, which can be varied along the length of each housing segment 111 and 131 (for example, within a certain range). Figure 1A The longitudinal axis 103 shown in FIG. 1 is uniform or non-uniform.

[0040] The needle bending assembly 102 can be made of any suitable material having sufficient or desired strength that can, for example, resist undesirable deformation, bending, flexing, tearing, warping, sagging, cracking, and / or any other process by which the surface and / or physical properties of the material may change and affect the ability to reproducibly and accurately bend the needle, etc. In some embodiments, each of the housing segments 111, 131 and the coupling element 121 can be formed of the same material(s). In other embodiments, at least one of the first housing segment 111, the second housing segment 131, and / or the coupling element 121 can be formed of different material(s). For example, in some embodiments, as described in further detail herein, the second housing segment 131 can be formed of a relatively strong or relatively hard material and / or can be otherwise enhanced to resist undesirable deformation, bending, flexing, tearing, puncturing, etc. caused by contact with a portion of the needle 101 during a needle bending operation, while the coupling element 121 can be formed of a relatively soft or flexible material that allows a desired amount of bending, flexing, etc. during a needle bending operation.

[0041] In some embodiments, needle bending assembly 102 or segments, elements and / or portions thereof can be formed of a material that allows elastic or non-permanent deformation and / or bending while resisting or otherwise limiting plastic or permanent deformation and / or bending. For example, in some cases, needle bending assembly 102 can be manipulated from an initial or undeformed state to a bent, rotated and / or reconfigured state to bend a portion of needle 101 disposed therein, and can then be allowed to return (substantially) to the same initial or undeformed state after needle 101 has been bent.

[0042] In some embodiments, the needle bending assembly 102 can be manufactured via injection molding using any suitable material (e.g., plastic). In addition, as described in further detail herein, at least a portion of the needle bending assembly 102 or the coupling element 121 can utilize and / or form a living hinge that is configured to elastically (non-permanently) deform to allow the second housing segment 131 to move relative to the first housing segment 111. In some cases, such a configuration can allow the needle bending assembly 102 to be formed unitarily or integrally, which in turn can simplify manufacturing, etc. In some cases, the needle bending assembly 102 and / or the coupling element 121 may include a mechanical hinge or other movable, bendable and / or flexible element that is at least partially formed by an outwardly facing convex surface, protuberance, etc. on the first housing segment 111 and a matching inwardly facing concave surface, dimple, etc. on the second housing segment 131 (or vice versa).

[0043] In some cases, injection molding can be used to separately form portions of needle bending assembly 102 (e.g., first housing segment 111 and second housing segment 131 can be manufactured separately), which are subsequently joined, coupled, attached, etc. For example, segments 111 and 131 can be separately formed (e.g., via injection molding) and can be joined via coupling element 121 (e.g., at least a portion of which can form a living hinge) in a subsequent manufacturing process (such as, for example, an overmolding process and / or a joining or coupling process such as an adhesive process, a welding process (e.g., ultrasonic welding), etc.). In some other cases, the bottom portions of the first shell segment 111 and the second shell segment 131 (having a connecting element 121 therebetween (e.g., forming a living hinge, etc.)) can be manufactured as a single part, while the top covers or top portions of the first shell segment 111 and the second shell segment 131 can be manufactured separately and connected to the corresponding bottom portions of the first shell segment 111 and the second shell segment 131 via suitable connecting elements (e.g., clamps, fasteners, etc.) or via a suitable connecting process (e.g., ultrasonic welding or other connecting or joining processes).

[0044] A non-limiting list of materials from which the needle bending assembly 102 may be formed may include, for example, metals, metal alloys, wood, glass, ceramics, polymers, and / or the like. In some embodiments, the needle bending assembly 102 (or portions or segments thereof) may be formed of a biocompatible material, which may be selected based on one or more properties of the constituent materials, such as, for example, stiffness, toughness, hardness, bioreactivity, etc. Non-limiting examples of suitable biocompatible metals may include pharmaceutical grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or alloys thereof. Non-limiting examples of suitable biocompatible polymeric materials can include polylactide, polyglycolide, polylactide-co-glycolide, polyethylene glycol, polyanhydrides, polyorthoesters, polyetheresters, polycaprolactone, polyesteramides, poly(butyric acid), poly(valeric acid), polyurethane, polyamide (nylon), polyester, polycarbonate, polyacrylate, polystyrene, polypropylene, polyethylene, polyethylene oxide, polyolefins, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), polyether polyurethane, silicone polyether polyurethane, polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), polylactones, chlorosulfonate polyolefins, ethylene-vinyl acetate and other acyl substituted cellulose acetates, elastomers, thermoplastics and / or blends and copolymers thereof. In some embodiments, the needle bending assembly 102 can be formed from any of these biocompatible polymeric materials using, for example, injection molding (as described above) and / or any other suitable manufacturing process or combination of processes.

[0045] The first housing segment 111 may be any suitable housing or structure that contains and / or otherwise defines a first cavity 113 (eg, a passage, lumen, or any other space of suitable shape, size, and / or configuration). Figure 1B The first housing segment 111 is shown configured to house and / or at least partially support the first needle portion 101A (e.g., within the first cavity 113) such that the first needle portion 101A is secured from movement or substantially movement in one or more directions, as indicated by arrow 113s. In some cases, the first needle portion 101A can be secured via one or more inner walls or surfaces of the first housing segment 111 that at least partially define the first cavity 113. In some cases, the first needle portion 101A can be secured by one or more protrusions or features that can extend from the inner wall(s) of the first housing segment 111 toward the first needle portion 101A. For example, a protrusion or the like extending from a side wall of the first housing segment 111 toward a corresponding side of the first needle portion 101A can be configured to limit or substantially prevent movement of the first needle portion 101A within the first cavity 113 in a direction toward the protrusion or feature. In some embodiments, one or more projections may extend on opposite sides of the first needle portion 101A, thereby limiting or substantially preventing movement of the first needle portion 101A in one or more directions (eg, side-to-side movement) along a plane passing through the one or more projections.

[0046] Similar to the first housing segment 111, the second housing segment 131 can be any suitable housing or structure that contains and / or otherwise defines a second cavity 133 (e.g., a channel, a lumen, or any other space of suitable shape, size, and / or configuration). The second housing segment 131 is configured to accommodate and / or at least partially support the second needle portion 101B (e.g., within the second cavity 133) such that the second needle portion 101B is fixed relative to the second cavity 133 or within the second cavity (e.g., at least at or near the distal end portion DE of the needle 101) to prevent movement or substantial movement in one or more directions, such as Figure 1BIn addition, optionally, the second housing segment 131 can support the second needle portion 101B to limit and / or substantially prevent movement relative to the second cavity 133 at the position indicated by the arrow 133s1. In some cases, the second needle portion 101B can be fixed via one or more inner walls or surfaces of the second housing segment 131 that at least partially define the second cavity 133. In some cases, the second needle portion 101B can be fixed by one or more suitable protrusions or features that can extend from the (multiple) inner walls of the second housing segment 131 toward the second needle portion 101B. For example, a protrusion extending from the side wall of the second housing segment 131 toward the corresponding side of the second needle portion 101B (e.g., at the position indicated by the arrow 133s2) can be configured to limit or substantially prevent the second needle portion 101A from moving in the second cavity 133 in the direction toward the protrusion or feature. In some embodiments, one or more projections may extend on opposite sides of second needle portion 101B, thereby limiting or substantially preventing second needle portion 101B from moving in one or more directions (eg, side-to-side movement) along a plane passing through the one or more projections.

[0047] The first housing section 111 and the second housing section 131 are coupled via a coupling element 121. The coupling element 121 may be any suitable element for allowing the second housing section 131 to move relative to the first housing section 111 while remaining attached to the first housing section 111. Figure 1B and Figure 1C As shown in , the arrangement of the needle bending assembly 102 is such that the third needle portion 101C is disposed or positioned between the first housing segment 111 and the second housing segment 131. In some embodiments, the third needle portion 101C can be disposed at a position corresponding to the coupling element 121. As further described in detail herein, for example, although in Figure 1B and Figure 1C Not shown, but in some embodiments, coupling element 121 can be in contact with at least a portion of third needle portion 101C.

[0048] Figure 1B The needle bending assembly 102 is shown in a first configuration, wherein the second housing segment 131 is substantially aligned with the first housing segment 111, and Figure 1CThe needle bending assembly 102 is shown in a second configuration, wherein the second housing segment 131 is rotated (e.g., clockwise, as indicated by arrow 134) about an in-page axis X1 passing through the coupling element 121. In this embodiment, the coupling element 121 can be a suitable hinge (e.g., a living hinge) or a flexible connection element (e.g., the flexible connection element can be a plastic strip, a rubber strip, a fiberglass strip, a fabric strip, etc.). In some cases, the coupling element 121 can have grooves, notches, convex surfaces, concave surfaces, ridges, pits, and / or any other structural elements that facilitate bending of the coupling element 121 at a specific position of the coupling element 121. It should be noted that the coupling element 121 implemented as a hinge or a flexible connection element is only one possible embodiment, and other connections or coupling elements can be used. For example, the coupling element 121 can be a ball joint connector, a mechanical hinge, and / or any other suitable connection element (e.g., the coupling element 121 can be a combination of several connection elements, such as a combination of hinges, flexible elements, etc.).

[0049] The coupling element 121 can be configured to allow a selected range of motion of the second housing segment 131. For example, the coupling element 121 can allow the second housing segment 131 to rotate to a selected angle (e.g., about 1 degree, 2 degrees, 3 degrees, 4 degrees, 5 degrees, 6 degrees, 7 degrees, 8 degrees, 9 degrees, 10 degrees, 11 degrees, 12 degrees, 13 degrees, 14 degrees, 15 degrees, 16 degrees, 17 degrees, 18 degrees, 19 degrees, 20 degrees or more), to a selected angle, and / or through a selected angle. In some embodiments, the selected angle can be about 5 degrees. In some embodiments, the coupling element 121 can be configured to allow the second housing segment 131 to rotate to at least one selected angle from a selected angle range (e.g., a selected angle range between 1 degree and 20 degrees). In some embodiments, the selected angle can include a degree or amount of overbending based at least in part on the needle 101 at least partially rebounding, relaxing, and / or partially straightening when the force causing the bending is removed. For example, in some embodiments, the second housing segment 131 may be allowed to rotate approximately 6 degrees relative to the first housing segment 111, which may slightly overbend the needle 101 to produce a final 5 degree bend after the needle 101 rebounds, relaxes, and / or partially straightens. Although described as a 1 degree overbend, it should be understood that the degree of overbend may be greater than or equal to 1 degree and may be based at least in part on one or more features or physical characteristics of the needle 101.

[0050] In some cases, as further described below, the coupling element 121 can allow the second housing segment 131 to rotate a predetermined and / or preselected angle, and in other cases, the user can select (referred to herein as dialing) the angle or amount of rotation. In some cases, when the coupling element 121 includes more than one connecting element, the movement of each connecting element can be independently controlled by the user.

[0051] like Figure 1C , movement of the second housing segment 131 (e.g., rotation of the second housing segment 131 about the axis X1 or through a selected angle) causes the needle 101 to bend. For example, in some embodiments, as described above with reference to the first needle portion 101A and the second needle portion 101B, respectively, the needle 101 may be configured to bend at or along the third needle portion 101C (at least for the reason that it is not supported by the inner wall (or protrusion, feature, etc.) of the first housing segment 111 and / or the second housing segment 131). In some embodiments, at least a portion of the coupling element 121 may be reconfigured, moved, deformed, bent, etc. to allow the second housing segment 131 to be moved or rotated relative to the first housing segment 111. In addition, the coupling element 121 may be in contact with the third needle portion 101C such that such reconfiguration, movement, deformation, bending, etc. causes the coupling element 121 to exert a force on the third needle portion 101C that is operable to bend the needle 101 at or along the third needle portion 101C.

[0052] Needle 101 includes an inner cavity that is axially oriented and extends throughout needle 101 (e.g., the inner cavity can extend continuously through each of the proximal portion PE and the distal portion DE of needle 101). The inner cavity can be used to deliver fluid to a patient, remove fluid from a patient (or tissue for biopsy purposes), and / or otherwise allow access to the internal portion of a patient (e.g., a human patient or a non-human patient, such as an animal). In some embodiments, during a needle bending procedure, a retention stylet (e.g., a thin wire) can be set in the inner cavity to ensure the structural stability of the inner cavity (e.g., to ensure that the inner cavity does not collapse or kink at the third needle portion 101C during the bending procedure). In some cases, the stylet can be made of a material having a rigidity modulus comparable to that of the metal forming the needle. For example, the stylet can be made of a material that is the same (or similar) as the material of needle 101. In some cases, the stylet extending through the inner cavity of needle 101 can be made of several different segments, each of which has a selected elastic property. For example, the stylet may have a first segment corresponding to the first needle portion 101A, a second segment corresponding to the second needle portion 101B, and a third segment corresponding to the third needle portion 101C. In some cases, the stylet may include a friction reducing coating (e.g., the coating may be a fluoropolymer such as etc.), so that the stylet can be easily withdrawn from the inner cavity of the needle 101 after the needle 101 is bent.

[0053] In some embodiments, a stylet or the like need not be disposed within the lumen of needle 101 for bending. For example, in some embodiments, needle 101 may be formed of a material and / or may have one or more characteristics configured to limit and / or substantially prevent kinking of needle 101. In some embodiments, to ensure that the lumen does not collapse (or deform) during the bending procedure, the degree of curvature at the curved portion of needle 101 (e.g., along third needle portion 101C) may be maintained below a maximum threshold. The curvature of the curved portion of needle 101 (e.g., along third needle portion 101C) may be based at least in part on the length of third needle portion 101C, which in turn may be controlled by the distance separating first housing segment 111 and second housing segment 131 and / or based at least in part on the distance separating first housing segment 111 and second housing segment 131. In embodiments where coupling element 121 contacts third needle portion 101C to bend needle 101, the curvature of the bend along third needle portion 101C may be based at least in part on the shape of a portion of coupling element 121 that contacts third needle portion 101C. For example, in some embodiments, coupling element 121 may be configured to deform when second housing segment 131 is rotated so that a relatively wide surface of coupling element 121 contacts third needle portion 101C, which in turn causes the force applied by coupling element 121 to be distributed over a sufficiently long portion of needle 101 to gradually bend needle 101, rather than, for example, kinking or abruptly bending needle 101.

[0054] In some embodiments, coupling element 121 may be configured to deform in or along multiple positions when second housing segment 131 is rotated, such that a desired surface at or along each position of the coupling element contacts a desired position or segment of third needle portion 101C. In such embodiments, the contact at multiple positions along third needle portion 101C may serve as and / or provide multiple fulcrums around which needle 101 is bent, which in turn may allow needle 101 to be bent to a greater degree, angle, and / or amplitude than would otherwise be possible by a single point of contact (or a single fulcrum around which needle 101 is bent). In some such embodiments, at least the size, length, and / or configuration of coupling element 121 may be selected based at least in part on the desired number and / or position of deformation points along coupling element 121, thereby allowing needle 101 to pass through any suitable angle.

[0055] Figure 2-18 Various views of an exemplary embodiment of a needle bending system 200 having a needle bending assembly 202 are shown, the needle bending assembly including a first housing segment 211, a second housing segment 231, and a coupling element 221. The various segments, cavities, components, etc. of the needle bending system 200 can be similar to the corresponding segments, cavities, components, etc. of the needle bending system 100. For example, Figures 1A-1CAs shown in , the housing segments 211 and 231 can be similar in at least form and / or function to the corresponding housing segments 111 and 131. The first housing segment 211 and the second housing segment 231 are connected by a coupling element 221, which can be similar in at least form and / or function to the coupling element 121 of the needle bending system 100. The first housing segment 211 defines a first cavity 213, and the second housing segment 231 defines a second cavity 233, which can be similar in at least form and / or function to the first cavity 113 and the second cavity 133, respectively.

[0056] Figure 2-7 The needle bending system 200 is shown in a first configuration, wherein the unbent needle 201 is housed in the first housing section 211 and the second housing section 231. More specifically, Figure 2 An isometric view of needle bending system 200 is shown showing needle bending assembly 202 housing needle 201 . Figure 3 and Figure 4 2 and 3 are side and top views, respectively, of the needle bending system 200 . Figure 5 It is along the Figure 4 5-5, which defines a cross-sectional plane, is a cross-sectional view of the needle bending system 200. Figure 6 yes Figure 5 An enlarged view of a portion of the needle bending system 200 is shown in FIG. Figure 7 is a rear view of the needle bending system 200 .

[0057] Although not shown, the needle bending system 200 may also include a stylet that may be disposed within the lumen of the needle 201. In some embodiments, the stylet may be disposed within the needle 201 during the bending operation so that both the needle 201 and the stylet are bent in the same process or by the same process. Alternatively, in some embodiments, the stylet may be disposed within the lumen of the needle 201 during insertion into the patient's body and may then be removed from the needle 201 before the bending operation. At the proximal portion PE, the needle 201 is connected to and / or includes a needle hub 241. Although not shown, the needle hub 241 may also be (at least temporarily) connected to the stylet hub to allow the needle 201 and / or the stylet to be controlled together and / or independently relative to the needle bending assembly 202. The distal portion DE of the needle 201 is located within the second housing segment 231. The needle hub 241 may be used by a medical professional (e.g., a physician, surgeon, etc.) to rotate, move, advance, remove, etc. the needle 201. For example, a medical professional can use the needle hub 241 to remove the needle 201 from the needle bending assembly 202 (e.g., after performing a bending procedure). In some embodiments, when the needle 201 is disposed in the needle bending assembly, the needle hub 241 and / or a portion thereof can be at least partially disposed in the first housing segment 211 of the needle bending assembly 202. In some embodiments, the proximal portion of the first housing segment 211 can be sized and / or shaped in a manner that allows the distal portion of the needle hub 241 to be disposed therein (see, e.g., Figure 5 ).

[0058] Figure 2Also shown is at least a second housing segment 231 having and / or forming one or more shapes, surfaces, features, etc. configured to enhance and / or facilitate the ergonomics (e.g., at least during a needle bending process) of the needle bending assembly 202. For example, a top side or top surface of the second housing segment 231 can include and / or form a notch 235 and / or any other suitable feature that can enhance and / or facilitate the ergonomics associated with a user gripping the second housing segment 231. Similarly, a bottom side or bottom surface 237 can be shaped, sized, and / or configured in a manner that enhances and / or facilitates the ergonomics associated with a user gripping the second housing segment 231 (e.g., the bottom side or bottom surface 237 can also have and / or form a notch or any other suitable feature (not shown)). In some cases, during use, a user (e.g., a medical professional) can clamp, grasp, hold, and / or otherwise engage the second housing segment 231 by placing one or more fingers of a first hand on the notch 235 on the top side or surface and on the bottom side or bottom surface 237 while holding the first housing segment 211 with a second hand. In some cases, the presence of the notch 235 can guide the finger(s) of the user's first hand to be placed on the top surface of the second housing segment 231 while the thumb of the user's first hand engages and / or contacts the bottom side or bottom surface 237 of the second housing segment 231 (or vice versa). As described in further detail herein, such an arrangement can facilitate user manipulation of the needle bending assembly 202 to, for example, rotate the second housing segment 231 relative to the first housing segment 211 to thereby bend the needle 201 contained therein. Although Figure 2-7 235, but in some embodiments, the recess 235 may include and / or form one or more features, or may have a surface finish, etc., configured to enhance the user's grip on the second housing segment 231. For example, the recess 235 may include one or more protrusions, ridges, channels, etc., and / or may have a knurled and / or otherwise textured finish. Similarly, the bottom side or bottom surface 237 may also have any suitable features and / or surface finishes.

[0059] When the needle bending system 200 is in the first configuration, the housing segments 211 and 231 are aligned or substantially aligned such that the longitudinal axis 203 of the needle bending assembly 202 extends through each of the housing segments 211 and 231. Figure 5, the first lumen 213 and / or portions thereof may be lumens or other openings extending along a first central axis, and the second lumen 233 and / or portions thereof may be lumens or other openings extending along a second central axis, wherein the alignment of the housing segments 211 and 231 is such that the first central axis is coaxial with the second central axis. In addition, the first central axis and the second central axis may be substantially aligned or coaxial with the longitudinal axis 203. The needle 201 may be disposed in the housing segments 211 and 231 and / or may extend at least partially through the housing segments such that the central (longitudinal) axis of the needle 201 is substantially aligned or coaxial with the longitudinal axis of the needle bending assembly 202.

[0060] like Figure 5 and Figure 6 , the first housing segment 211 includes a set of inner walls defining a first cavity 213. As described above with reference to the needle bending assembly 102, the inner walls may be configured to contact the first needle portion 201A (or at least a portion thereof) disposed in the first housing segment 211, and / or may include one or more features configured to contact the first needle portion (or at least a portion thereof) disposed in the first housing segment, which may in turn support the first needle portion 201A to limit and / or substantially prevent undesired movement, bending, flexing, etc. of at least a portion of the needle 201. Similarly, the second housing segment 231 includes a set of inner walls defining a second cavity 233, which receives and / or at least temporarily accommodates the second needle portion 201B. In some embodiments, the second cavity 233 may have and / or may be defined as having a diameter D2 that is large enough to allow the second cavity 233 to accommodate the second needle portion 201B of the needle 201, even when the needle 201 is bent. Additionally, in some embodiments, as further described in detail herein, the arrangement of the inner wall of the second housing segment 231 can be such that transitioning the needle bending system 200 from the first configuration toward the second configuration places a portion of the inner wall in contact with the second needle portion 201B, thereby facilitating bending of the needle 201.

[0061] Figure 6Additional details of the coupling element 221 are shown, and a first shoulder 212 included in and / or formed by the first shell segment 211 and a second shoulder 232 included in and / or formed by the second shell segment 231 are shown. The coupling element 221 can be any suitable coupling or the like that can allow the second shell segment 231 to be moved, rotated, and / or reconfigured relative to the first shell segment 211. In some embodiments, the first shoulder 212 and the second shoulder 232 can be configured to at least partially define and / or control the degree and / or angle associated with bending or rotation of the second shell segment 231 relative to the first shell segment 211. In other words, the coupling element 221 can allow and / or enable movement, rotation, and / or reconfiguration of the second shell segment 231 relative to the first shell segment 231, and the shoulders 212 and 232 can at least partially define the magnitude, degree, angle, and / or range of motion associated with the movement, rotation, and / or reconfiguration.

[0062] For example, Figure 6 A point or surface 216 of the first shoulder 212 and a point or surface 236 of the shoulder 232 are shown that contact or are configured to contact when the second housing segment 231 is bent relative to the first housing segment 211. The points or surfaces 216 and 236 can be, for example, the closest separation points or surfaces of the shoulders 212 and 232, and the distance between these points or surfaces 216 and 236 can at least partially determine, limit and / or control the range of motion through which the second housing segment 231 can be rotated relative to the first housing segment 211. In some cases, for example, the rotation of the second housing segment 231 can be stopped and / or limited in response to the point 216 contacting the point 236. In some cases, for example, a user can apply a force sufficient to rotate the second housing segment 231 relative to the first housing segment 211 (e.g., a force sufficient to deform the coupling element 221 and bend the needle 201). Generally speaking, a user can apply a force to rotate the second body segment 231 through a predetermined angle or range of motion until the surfaces 216 and 236 of the shoulders 212 and 232 contact. The contact between the surfaces 216 and 236 then resists further rotation of the second body segment 231, which can be felt by the user because the same amount of applied force no longer rotates the second body segment 231 relative to the first body segment 211. In other words, the contact between the surfaces 216 and 236 can result in a hard stop or limit to the bending process, which the user can perceive as a significant increase in resistance to further rotation of the second body segment 231.

[0063] It should be noted that the shoulder 212 and / or shoulder 232 can have any suitable size and shape, which can be selected based on the desired amount or angle of rotation of the second housing segment 231 relative to the first housing segment 211. In other words, the shoulder 212 and / or 232 can be sized and / or shaped based at least in part on the desired amount or angle of bend of the needle 201. In an exemplary embodiment, the shoulder 212 and / or 232 can be or include a set of protrusions extending from the first housing segment 211 and / or the second housing segment 231, respectively. For example, as Figure 7 , the first shoulder 212 can form two protruding elements at the bottom portion of the first shell segment 211. In some embodiments, both shoulders 212 and 232 can be implemented as protrusions at the bottom portions of the respective first shell segment 211 and the second shell segment 231. In some embodiments, the shoulders 212 and 232 can be similar or substantially identical in at least size and / or shape. In such embodiments, for example, the size and / or shape of at least portions of the shoulders 212 and 232 that form or include the points or surfaces 216 and 236, respectively, can be similar. In other embodiments, the shoulders 212 and 232 can be differently sized and / or shaped, and / or at least the points or surfaces 216 and 236 can be differently sized and / or shaped. In some such embodiments, the size, shape and / or configuration of the first shoulder 212 and the second shoulder 232 may be selected such that rotation of the second shell segment 231 relative to the first shell segment 211 has a desired set of characteristics, such as, for example, the amount of force required to rotate the second shell segment 231 a desired amount.

[0064] As described above, coupling element 221 can be and / or can include any suitable coupling or connector configured to attach second housing segment 231 to first housing segment 211. In some embodiments, for example, coupling element 221 can be and / or can form a living hinge or the like that can attach housing segments 211 and 231 while allowing second housing segment 231 to be moved, rotated, and / or otherwise reconfigured relative to first housing segment 211. As described above with reference to coupling element 121, Figure 5 and Figure 6The coupling element 221 shown in can be any suitable size and / or shape, and / or can include any suitable features, etc. that can at least partially define, determine and / or control one or more characteristics associated with bending or flexing of the coupling element 221. In some embodiments, for example, the coupling element 221 can include and / or can form one or more discontinuities, protrusions, ridges, channels, slits, etc. that can facilitate bending and / or flexing of the coupling element 221. In some embodiments, the coupling element 221 can include engineered properties, features, weaknesses, etc. that can facilitate bending and / or flexing of the coupling element 221. For example, in some embodiments, a discontinuity, weakness, feature, etc. can be formed or included in the coupling element 221, which can at least partially control and / or determine the location or degree of deformation of the coupling element 221 in response to a force applied to rotate the second shell segment 231 relative to the first shell segment 211. In other embodiments, the coupling element 221 need not include such discontinuities, properties, features, etc.

[0065] Figure 8-13 The needle bending system 200 is shown in a second configuration, wherein the second housing segment 231 has been rotated and / or bent relative to the first housing segment 211 to bend the needle 201 housed in the needle bending assembly 202. For example, Figure 8 is an isometric view of the needle bending system 200 in a second configuration showing the second housing segment 231 rotated about the axis X1 defined by the coupling element 221 . Fig. 9 is a side view of the needle bending system 200 in the second configuration, showing the second housing segment 231 rotated relative to the first housing segment 211 by an angle More specifically, Fig. 9 A first central axis 214 extending through the first housing segment 211 and a second central axis 234 extending through the second housing segment 231 are shown, wherein the angle Defined between axis 214 and axis 234 .

[0066] Fig.10 shows a top view of the needle bending system 200 in a second configuration, and Fig.11 Shown along the Fig.10 00 is a cross-sectional view of the needle bending system 200 in a second configuration, taken along line 11 - 11 indicating a cross-sectional plane. Fig.12 yes Fig.11 00 is an enlarged view of a portion of the needle bending system 200 in a second configuration as identified in FIG. Fig.13 is a rear view of the needle bending system 200 in a second configuration.

[0067] Fig.12It is shown that when the second housing segment 231 is rotated relative to the first housing segment 211, the inner wall 231A of the second housing segment 231 is placed in contact with the distal tip 201D of the needle 201. In this way, a portion of the force applied to the second housing segment 231, which is operable to rotate the second housing segment 231, is transmitted and / or applied to the distal tip 201D of the needle 201, which in turn can bend the needle 201 to a desired and / or predetermined angle.

[0068] As described above, in some embodiments, the shape, size, and / or configuration of the needle bending assembly 202 can be selected to control one or more characteristics associated with the bending of the needle 201. For example, in some embodiments, one or more characteristics associated with the contact between the inner wall 231A and the distal tip 201D of the needle 201 can be based at least in part on the diameter D2 of the second lumen 233 (or at least a portion thereof), the length of the second needle portion 201B disposed in the second housing segment 231, the relative position between the coupling element 221 and the inner wall 231A, etc. In some embodiments, the contact position along the distal tip 201D of the needle 201 and / or the length of the second needle portion 201B disposed in the second housing segment 231 can determine and / or at least partially control the relationship between the amount or angle of rotation of the second housing segment 231 and the amount or angle of bending of the needle 201. For example, in some embodiments, increasing the length of the second needle portion 201B disposed in the second housing segment 231 relative to a shorter length can increase the amount or angle of bending of the needle 201. Additionally, in some embodiments, the length of the second needle portion 201B and / or one or more characteristics of the inner wall 231A may be selected to reduce the likelihood of the distal tip 201D piercing the second shell segment 231 and / or reduce the likelihood of the distal tip 201D being damaged by contact with the inner wall 231A.

[0069] The shape, size, and / or configuration of the needle bending assembly 202 may be selected based on the length and / or width of the needle 201. For example, some known spinal puncture needles may have a length of several inches (e.g., 3.5 inches, 5 inches, 7 inches, etc.), and the length of the first housing segment 211 (and / or the second housing segment 231) may be selected based on this length. As shown, the length of the first housing segment 211 is shorter than the length of the needle 201, and thus may be varied based at least in part on the length of the needle 201. In an exemplary embodiment, the length of the first housing segment 211 may be shorter than the length of the needle 201 by 0.5 inches, 1 inch, 1.5 inches, 2 inches, 2.5 inches, 3 inches, 3.5 inches, etc., or any length or fraction of a length therebetween. In some cases, the length of the first housing segment 211 can be, for example, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30% or less of the length of the needle 201 (or any percentage or fraction of a percentage therebetween). In some cases, the length of the first housing segment 211 can be in the range between 95%-30% of the length of the needle 201, including all values ​​and ranges therebetween. Furthermore, by varying the length of the first housing segment 211 based on the length of the needle 201, the length of the distal portion DE of the needle 201 that is aligned with and / or corresponds to the coupling element along the needle 201 and disposed in the second housing segment 231 can be varied, adjusted, tuned, selected, etc. In this way, the location along the needle that forms the bend and / or the degree or amount of the bend imparted to the needle 201 can be varied, adjusted, tuned, selected, etc.

[0070] The cross-sectional shape and / or area of ​​the first cavity 211 and / or the second cavity 213 (or at least a portion thereof) may also be based at least in part on the specifications of the needle 201. For example, the cross-sectional area of ​​the first cavity 213 and / or the second cavity 233 may be selected to have a shape and / or size at least at some locations along the longitudinal axis 203 based at least in part on the specifications or cross-sectional area of ​​the needle 201 that allows the needle 201 to be supported within the first housing segment 211 and the second housing segment 231 while also allowing the needle 201 to be bent and withdrawn from the needle bending assembly 202.

[0071] In some embodiments, one or more properties, aspects, features, etc. of coupling element 221 may be selected to facilitate bending of needle 201 in a desired and / or predetermined manner. Fig.12A coupling element 221 is shown in contact with a third needle portion 201C disposed between the first housing segment 211 and the second housing segment 231. When the coupling element 221 allows the second housing segment 231 to be rotated relative to the first housing segment 211, at least a portion of the coupling element 221 can deform and / or deflect. In some embodiments, the deformation and / or deflection can be controlled and / or directed (e.g., based on one or more features or characteristics of the coupling element 221) so that a portion of the coupling element 221 is pushed in and / or toward the direction of the third needle portion 201C, which in turn applies a force along the third needle portion 201C. Thus, when at least a portion of the force used to rotate the second housing segment 231 is transmitted to the distal tip 201D of the needle 201, the coupling element 221 (or the force applied by the coupling element 221) can serve as and / or provide a fulcrum around which the third needle portion 201C can be bent.

[0072] In some embodiments, one or more properties, aspects, features, etc. of the needle bending assembly 202 and / or the coupling element 221 can be selected to facilitate bending the needle 201 to or having a particular curvature or property. For example, the needle 201 can be bent such that a portion of the needle 201 (e.g., at or along the third portion 201C of the needle 201) has a constant, gradual, and / or wide curvature (e.g., a bend having a relatively large radius of curvature) at the third portion 201C. In some embodiments, the curvature of the bend along the third portion 201C of the needle 201 can have and / or can form a Gaussian shape that varies with the amplitude or length of the third portion 201C of the needle 201 (e.g., the length of the portion of the needle 201 disposed between the first housing segment 211 and the second housing segment 231). In other embodiments, the curvature of the bend along the third portion 201C of the needle 201 can have any other suitable functional dependency of the amplitude or length of the third portion 201C (e.g., a hat function, a step function, etc.). In some cases, the needle bending assembly 202 can be configured to impart or create, for example, a dog-leg bend at or along the third portion 201C, characterized by a relatively sharp bend, such as a bend having a relatively small radius of curvature (e.g., a bend at about 20°, about 30°, about 40°, about 50°, about 60°, about 70°, about 80°, about 90°, or any other suitable angle, and having a relatively small radius of curvature). In some embodiments, the bend formed along the third portion 201C can be based at least in part on the type of needle or procedure in which the curved needle 201 will be used. For example, in some cases, it may be desirable to form a bend having a relatively large and constant radius of curvature when the needle 201 is intended for use in a biopsy procedure (e.g., the needle 201 is a biopsy needle) because the relatively large or wide arc of the bend can allow for easier access to the target tissue being sampled.

[0073] In some embodiments, one or more characteristics, aspects, features, etc. of the needle bending assembly 202 can be selected to facilitate or impart overbending of the needle 201. For example, "overbending" can refer to the process of bending the needle 201 by a greater or greater angle or amount than a desired angle or amount based on a determination and / or expected relaxation of a portion of the needle 201 to achieve a desired target bending angle or amount. In some embodiments, the amount of relaxation can be determined based on one or more characteristics of the needle 201 (such as, for example, the elasticity, flexibility, hardness, toughness, etc. of the constituent materials of the needle 201). In some embodiments, for example, the needle 201 can be overbent by about 0.5%, 1.0%, 1.5%, 2.0%, 2.5%, 3.0%, 3.5%, 4.0%, 4.5%, 5.0%, 10%, 15%, 20%, or any percentage or fraction of a percentage therebetween. In some embodiments, the needle 201 can be overbent by less than 0.5% or greater than 20%.

[0074] In some embodiments, second housing segment 231 can be configured to at least partially stabilize needle 201 during the bending process, which in turn can facilitate controlling the bending of needle 201. For example, Fig.12 A wall of the second housing segment 231 (e.g., adjacent the coupling element 221) is shown defining an opening 231B through which the needle 201 can extend to allow the second needle portion 201B to be disposed in the second housing segment 231. In some embodiments, the size, shape, location, and / or configuration of the opening 231B can be selected so that one or more surfaces of the wall defining the opening 231B engage and / or contact a surface of the needle 201. In this manner, contact between one or more surfaces defining the opening 231B and a surface of the needle 201 can be used to stabilize at least the second needle portion 201B relative to the second housing segment 231. Thus, when the second housing segment 231 is rotated relative to the first housing segment 211, the force applied to the needle 201, the point along the needle 201 at which the force is applied, and / or any other optional, adjustable, tunable, or desired aspect or feature of the needle bending system 200 can collectively control the manner and / or degree of bending imparted to the needle 201. Furthermore, such arrangements, features, aspects, etc. may allow the needle 201 to bend in a desired, predictable, and repeatable manner.

[0075] Figure 14-18 Needle bending system 200 is shown as needle 201 is withdrawn from needle bending assembly 202 (eg, after bending needle 201). Fig.14 is an isometric view of the needle bending system 200, Fig.15 is a side view of the needle bending system 200, and Fig.16 is a top view of the needle bending system 200 . Fig.17 Shown along the Fig.16A cross-sectional view of the needle bending system 200 when the bent needle 201 is withdrawn, taken along line 17-17 defining the cross-sectional plane indicated in . In some embodiments, the arrangement of the needle bending assembly 202 can be such that after the needle 201 is bent, the needle bending system 200 can be transitioned from the second configuration to a third configuration. In the third configuration, the needle bending system 200 can be in a state and / or configuration similar to or substantially the same as the first configuration, but the needle 201 disposed in the needle bending assembly 202 is now bent. In other words, in some embodiments, the second housing segment 231 can be returned to its unmoved or unrotated position relative to the first housing segment 211. As Fig.14 and Fig.15 As shown in , needle 201 is withdrawn from needle bending assembly 202 via needle hub 241, which in turn allows needle 201 to be bent for use in a medical procedure. Fig.17 The needle 201 is shown withdrawn from the second housing segment 231 and partially withdrawn from the first housing segment 211. As described above, the size, shape, and / or configuration of the first cavity 213 and the second cavity 233 can be such that the needle 201 can be moved (e.g., along or relative to the longitudinal axis 203 of the needle bending assembly 202) after being bent. For example, Fig.18 yes Fig.17 , showing the needle 201 withdrawn from the second housing segment 231. As shown, the first lumen 213 has a sufficiently large diameter D1 so that the bent needle 201 can pass through the first lumen 213 when the bent needle 201 is pulled out of the needle bending assembly 202.

[0076] Figure 19-24 An exemplary embodiment of a needle bending system 300 is shown having a first housing segment 311 and a second housing segment 331. The first housing segment 311 defines a first cavity 313, and the second housing segment 331 defines a second cavity 333. The needle 301 includes portions that are accommodated or accommodated in the first housing segment 311 and the second housing segment 331. In addition, a portion 301C of the needle is located between the first housing segment 311 and the second housing segment 331. The various segments, cavities, components, etc. of the needle bending system 300 can be similar to the corresponding segments, cavities, components, etc. of the needle bending systems 100 and / or 200. Fig.19 Needle bending system 300 is shown in a first configuration, wherein needle 301 in an unbent configuration is housed in first housing segment 311 and second housing segment 313. As shown, at least a portion of first lumen 313 is aligned with at least a portion of second lumen 333, thereby allowing needle 301 to extend therethrough. Fig. 20The needle bending system 300 is shown in a second configuration, wherein the second housing segment 331 is rotated by an angle θ relative to the first housing segment 311 , which in turn imparts a bend along a portion of the needle 301 disposed in the needle bending assembly 302 .

[0077] In some embodiments, the first cavity 313 and the second cavity 333 may be inner cavities extending through the first shell segment 311 and the second shell segment 331, respectively. The first shell segment 311 and the second shell segment 331 are connected by a connecting element 321, which is a hinge element in an exemplary embodiment. In addition, similar to the shoulders discussed above, the first shell segment 311 and the second shell segment 331 include shoulders 312 and 332, respectively. Fig.19 As shown in FIG. 1 , shoulder 312 is separated from shoulder 332 at points or surfaces 316 and 336 by a distance L. In an exemplary embodiment, points and / or surfaces 316 and 336 are the closest points or surfaces between shoulders 312 and 332. Points or surfaces 316 and 336 are separated (e.g., vertically) by a distance H (e.g., Fig.19 ), and the line between the center of the coupling element 321 and the corresponding points 316 and 336 defines an angle θ by which the second shell segment 331 can rotate relative to the first shell segment 311. In an exemplary embodiment, the angle θ is given by θ=2·atan(L / 2H). In addition, as Fig.19 As shown in , one or more walls defining the first cavity 313 may support the needle 301 at least at the point indicated by the arrow S1, while one or more walls defining the second cavity 333 may support the needle 301 at least at the point indicated by the arrow S2. In this embodiment, a portion 301C of the needle 301 is defined between the points S1 and S2.

[0078] exist Figure 19-24 In the exemplary embodiment shown in , the second lumen 333 is expanded and / or can be otherwise extended in at least one direction (e.g., vertical direction and / or lateral direction) to provide sufficient space for a portion 301B of the needle 301 after the bending process. For example, Fig.21 The second cavity 333 with the portion 301B of the needle 301 is shown (i) after the needle 301 is bent and (ii) after the second housing segment 331 returns or substantially returns to the unmoved or unrotated position. In this example, the lateral direction is aligned with the coordinate Z (e.g., in and out of the page), the axial direction is aligned with the coordinate X, and the vertical direction is aligned with the coordinate Y. Fig.19 , Fig.21 and Fig.23The second housing segment 331 is shown to have a wall adjacent to the coupling element 321 that defines a slit 333s (e.g., an opening, passage, channel, orifice, etc. that expands or extends in the lateral (Z) direction but narrows in the vertical (Y) direction). In some embodiments, this arrangement can be such that the wall defining the slit 333s supports the needle 301 (e.g., at a point indicated by arrow S2, such as Fig.19 ).

[0079] like Fig.21 and Fig. 22 As shown in , the second cavity 333 can be in the shape of a semi-cylinder, wherein the radius R is greater than the vertical displacement h of the portion 301B of the needle 301 after bending. This shape of the second cavity 333 can allow the second housing segment 331 to move or rotate relative to the first housing segment 311 to bend the needle 301, allow the second housing segment 331 to return to a substantially non-moved or substantially non-rotated configuration, wherein the portion 301B of the needle 301 (after bending) is disposed in the second cavity 333, and further allow the needle 301 to be rotated to a position such as Fig.23 In some embodiments, for example, needle 301 can be rotated 90 degrees about the X-axis so that portion 301B of needle 301 extends in a lateral direction (e.g., along the Z-axis). Once needle 301 is positioned as shown in FIG. Fig.23 , it can be pulled through the slit area 333s and out of the second cavity 333. Fig.24 As shown in , the first cavity 313 can similarly be defined in the form or shape of a slit (e.g., in a lateral direction) so that when portion 301B is rotated, the needle 301 can be pulled through the first cavity 313 so that it is guided transversely to the first housing segment 311.

[0080] It should be noted that Figure 19-24 The embodiment shown in is only one possible embodiment of a needle bending system, and various other embodiments are possible. For example, Fig.25 and Fig.26 An exemplary embodiment of a needle bending system 400 is shown. Fig.25 4. The second housing segment 431 of the needle bending assembly 402 of the needle bending system 400 is shown, which defines a second cavity 433 having two regions (a first region 433A and a second region 433B). The first segment 433A is configured to accommodate and / or receive the needle 401 before the needle 401 is bent. After the process of bending the needle 401 (as described above), for example, by relative to the corresponding first housing segment ( Fig.25 and Fig.26By rotating the second housing segment 431 (not shown), the needle 401 can be moved in the lateral direction (as indicated by arrow A1) into the second region 433B of the second cavity 433 for subsequent removal from the second housing segment 431 (as indicated by arrow A2). Note that the first cavity of the corresponding first housing segment (not shown) can have a shape similar to the second cavity 433 (e.g., the first cavity can also have a first region and a second region, which can be similar to the corresponding first region 433A and second region 433B). Thus, the needle bending system 400 can be used to bend the needle 401 to a desired amplitude (as described above), and then can allow the needle 401 to be withdrawn from the needle bending assembly 402.

[0081] Fig. 27 and Fig.28 Another embodiment of a needle bending system 500 having a window for determining the position of the tip of a needle 501 within the second housing section 531 of a needle bending assembly 502 is shown. Fig. 27 A side view of a needle bending system 500 is shown, and Fig.28 A top view of the needle bending system 500 is shown. In this embodiment, a window 534 (or opening) can be placed, formed and / or defined at or through the top wall of the second housing segment 531 (or placed, formed and / or defined at or through any other wall, such as one of the side walls or the bottom wall of the second housing segment 531), thereby allowing a user to (e.g., visually) detect the position of the tip of the needle 501 within the second cavity 533. In this exemplary embodiment, the position or depth of the tip of the needle 501 can be determined via a ruler or scale marking 535 (or any other suitable marking) adjacent to one side of the window 534. Having the window 534 with the ruler marking 535 (or other marking) can allow the user to move the needle 501 relative to the second cavity 533 (e.g., in an axial or longitudinal direction or in an axial or longitudinal direction) before bending the needle 501, thereby allowing the user to select the location of the bend of the needle 501.

[0082] Fig.29 and Fig.30 Two embodiments of another exemplary embodiment of a needle bending system 600 are shown, which has the additional function of adjusting the bending angle θ by adjusting the distance L between the first shoulder 612 of the first housing segment 611 and the second shoulder 632 of the second housing segment 631. Fig.29In the exemplary embodiment shown in , the first shoulder 612 is configured to move toward or away from the second shoulder 632, as shown by arrow 617. In some cases, the first shoulder 612 can move relative to the first shell segment 611 while the first shell segment 611 remains in a fixed position relative to the second shell segment 631. Fig.29 , the first shoulder 612 may be configured to be movable via a suitable motion actuation mechanism (e.g., via a dial 619 that may be rotated as indicated by arrow 618). In some embodiments, the dial may be adjacent to an angle mark 616 (or other indicia) indicating the angle θ being selected by rotating the dial 619, which in turn may correspond to an amount of linear movement of the first shoulder 611. For example, the first shoulder 612 may be operably coupled to the first housing segment 611 via any suitable coupling mechanism (e.g., a track, a gear, a rack and pinion, etc.) for linearly moving (e.g., translating) the first shoulder 612 relative to the first housing segment 611 in response to rotation of the dial 619 (or any other suitable actuation).

[0083] Fig.30 A similar embodiment of the needle bending system 600 is shown, but in which the second shoulder 632 is configured to be adjusted by moving the second shoulder 632 relative to the second housing segment 631 and therefore relative to the first shoulder 612 as indicated by arrow 637. In this exemplary embodiment, as indicated by arrow 638, the second shoulder 632 can be moved linearly or otherwise translated in response to rotation of the dial 639. In other embodiments, the second shoulder 632 can be moved via any suitable activation and / or actuation. Although Fig.29 and Fig.30 Individual embodiments are shown and described, but in some examples, the embodiments may be combined such that each of the first shoulder 612 and the second shoulder 632 may be moved.

[0084] It should be noted that various other characteristics, aspects, features, etc. of the needle bending assembly may be selected to adjust the bending angle, such as Fig.29 and Fig.30 Although shoulders 612 and 632 are described above as being translated or moved in substantially linear directions along first housing segment 611 and second housing segment 631, respectively, in other embodiments, one or more shoulders of the needle bending assembly may be moved, adjusted, and / or reconfigured in any suitable manner. For example, one or more shoulders of the needle bending assembly (e.g., shoulders may be similar to those of FIG. Fig.29 and Fig.30The shoulders 612 and 632 shown in the figure can be configured to rotate about an axis (e.g., a bending axis defined by the coupling element) to change the separation distance between the shoulders or their contact surfaces. In addition, the shoulders can form contact surfaces, etc., which have a shape that changes in the lateral direction (e.g., entering or leaving the page or otherwise along the bending axis defined by the coupling element) so that the separation distance between the shoulders changes in the lateral direction. In such embodiments, one or more of the shoulders can be configured to move in the lateral direction, thereby adjusting the separation distance between the shoulders based at least in part on the position of the (multiple) shoulders in the lateral direction. In other embodiments, one or both of the shoulders can have a section that can be removed (e.g., disconnected) to modify the shape and / or size of one or both of the shoulders, and then modify the separation distance between the shoulders. Therefore, one or more of the above-mentioned movements or modifications of the shoulders (or any other suitable movements or modifications) can allow for further control and / or adjustment of the bending angle θ.

[0085] It should be appreciated that various other embodiments of the needle bending system may be used, including various ways of adjusting parameters, distances, etc. of components of the needle bending system. For example, in one embodiment, a first housing segment may be configured to move closer to (or farther from) a second housing segment, thereby adjusting the length of a segment of the needle located between the first housing segment and the second housing segment. Such adjustments may affect (e.g., increase or decrease) the curvature of the needle in the curved segment of the needle (e.g., for the same amount or angle of rotation of the second housing segment relative to the first needle segment, if the distance L between the first housing segment and the second housing segment increases, the degree of curvature of the needle may decrease).

[0086] Figure 31-35 700. The needle bending system 700 includes a needle bending assembly 702 and a needle assembly 740 removably coupled to the needle bending assembly 702. The needle bending assembly 702 may include a first housing segment 711, a second housing segment 731, and a coupling element 721 that movably couples the housing segments. The needle bending system 700 may be similar in form and / or function to the needle bending assembly 702 described above. Figure 2-18 The needle bending system 200 is described herein, and therefore, portions and / or aspects of the needle bending system 700 and / or needle bending assembly 702 are not described in further detail herein. Figure 31-35 The embodiment shown in FIG. 7 may differ from the needle bending system 200 in the arrangement and / or manner of engagement between the needle assembly 740 and the needle bending assembly 702. For example, in FIG. Figure 31-35In the embodiment shown in , at least a portion of the needle bending assembly 702 has been constructed and / or otherwise adapted to selectively engage and / or receive a portion of the needle assembly 740 to, for example, facilitate alignment and / or positioning of a known needle assembly relative to the needle bending assembly 702.

[0087] For example, in some embodiments, the needle bending assembly 702 can be used with a known needle assembly, such as a spinal puncture needle manufactured by Spectra Medical Devices, LLC (referred to herein as a Spectra needle). Figure 31-33 A needle assembly 740 (e.g., a Spectra needle) is shown including a needle hub 741 and a needle 701 coupled to and extending distally from the needle hub. In some embodiments, when the needle assembly 740 is removably coupled to the needle bending assembly 702, the needle 701 and the distal portion 742 of the needle hub 741 can be selectively received and / or inserted into a portion of the needle bending assembly 702. For example, as described in detail above with reference to the first cavity 213, the first housing segment 711 has an inner surface defining a cavity 713 that is configured to receive a portion of the needle 701 and the distal portion 742 of the needle hub 741.

[0088] Although some needle hubs may include a generally circular distal portion, Fig.31 The distal end portion 742 of the needle hub 741 is shown to include a set of projections forming a cross-shaped pattern. Fig.32 and Fig.33 As shown in , the shape and / or size of the inner surface at or along the proximal portion of the first housing segment 711 is set to correspond to the size, shape and / or configuration of the distal portion 742 of the needle 742 (or has a shape and / or size that is at least partially based on the size, shape and / or configuration of the distal portion of the needle). In this embodiment, for example, the inner surface defining the cavity 713 at or along the proximal portion of the first housing segment 711 may have and / or form a set of recesses, grooves, channels, etc. (referred to herein as "grooves 715"), which are arranged in a cross-shaped pattern that substantially corresponds to the cross-shaped pattern of the distal portion 742 of the needle hub 741.

[0089] In some embodiments, the groove 715 or at least a portion thereof may be oversized relative to the protrusion of the needle hub 741 to allow for acceptable tolerances during manufacturing, assembly, and / or use. For example, the size, shape, and / or arrangement of the groove 715 (or at least a portion of the groove 715) may selectively allow the needle assembly 740 to be rotated or spun about its longitudinal axis. Fig.34 As shown in , the groove 715 or at least a portion thereof can be tapered or otherwise arranged in a funnel-like configuration. In some embodiments, as Fig.35 As shown in , this arrangement can provide and / or act as a self-centering feature that allows for a certain degree of misalignment when the distal portion 742 of the needle hub 741 is inserted into the cavity 713, and gradually directs or guides the needle hub to align as the needle hub 741 advances in the distal direction. In addition, after bending the needle 701, the tapered or funnel-shaped arrangement of the groove 715 can allow the needle assembly 740 to be rotated and / or spun to facilitate the withdrawal of the needle 701 from the needle bending assembly 702 (e.g., in a manner similar to Figure 19-24 ).

[0090] Figure 33-35 Also shown is a proximal portion of the first housing segment 711, which includes one or more indicators, keying features, alignment features, etc. (referred to as "alignment features 704") that can be used to align or verify the alignment of the needle assembly 740 relative to the needle bending assembly 702. The desired positioning and / or alignment of the needle assembly 740 relative to the needle bending assembly 702 can ensure or substantially ensure that the needle 701 is bent in or along a desired portion or section of the needle 701. Similarly, the desired positioning and / or alignment of the needle assembly 740 relative to the needle bending assembly 702 can ensure or substantially ensure that the needle 701 is bent in a desired direction (e.g., relative to the beveled distal tip of the needle 701).

[0091] In some embodiments, the alignment feature 704 can selectively engage one or more surfaces at the distal portion 742 of the needle hub 741 to at least temporarily secure, constrain, and / or lock the needle hub 741 relative to the needle bending assembly 702. After bending, engaging and / or manipulating the alignment feature 704 can release and / or otherwise disengage the alignment feature 704 from the distal portion 742 of the needle hub 741, thereby allowing the needle assembly 740 to be moved (e.g., withdrawn) relative to the needle bending assembly 702.

[0092] A medical professional can use any of the embodiments described herein to bend a needle (e.g., a spinal puncture needle) in a selected, predetermined, and / or desired manner, for example, prior to inserting the needle into a patient. The needle bending system described herein can allow and / or provide consistent, predictable, and / or repeatable needle bending (e.g., bending a needle to a specified, predetermined, and / or desired angle). In various embodiments, the needle bending system can be prepackaged and comprised of a needle at least partially contained within a needle bending assembly. In addition, the needle can be connected to a needle hub at a proximal end (outside the needle bending assembly) while the distal end of the needle is placed or has been placed within the needle bending assembly. A medical professional can use the needle bending assembly to bend the needle at or near the distal portion of the needle and then remove or withdraw the needle from the needle bending assembly (e.g., by pulling on the needle hub).

[0093] Fig.36 is a flow chart illustrating a method 800 of bending a needle using a needle bending system such as any of those described herein. In some embodiments, for example, a needle can be pre-set in a needle bending assembly and / or system (referred to herein as a needle bending assembly) having a first housing segment, a second housing segment, and a coupling element coupling the first housing segment and the second housing segment. Pre-setting in the needle bending assembly can be, for example, during one or more manufacturing processes or steps (e.g., allowing the needle bending assembly and the needle to be sterilized and packaged together). Alternatively, a medical professional can set the needle in the needle bending assembly at the time of use (e.g., during a medical procedure). In this way, the needle can be set at a selected position within the first housing segment and the second housing segment of the needle bending assembly.

[0094] At step 801, with the needle positioned in a needle bending assembly, a method 800 of bending a needle includes transitioning a second housing segment from a first configuration to a second configuration relative to a first housing segment. In an exemplary embodiment, as described in detail above with respect to a specific embodiment, the transition includes rotating the second housing segment through a predetermined range of motion relative to the first housing segment. For example, as described in detail above, the needle bending assembly can be transitioned from a first (initial) configuration when the first housing segment (or at least a portion or a central axis thereof) is aligned with the second housing segment (or at least a portion or a central axis thereof) to a second configuration in which the second housing segment (or at least a portion or a central axis thereof) is misaligned, moved, rotated, etc. by a desired amount or angle relative to the first housing segment (or at least a portion or a central axis thereof).

[0095] At 802, as a result of the transition, a segment of the needle between the first housing segment and the second housing segment is engaged by a coupling element of a needle bending assembly. For example, the needle can be positioned in the needle bending assembly (e.g., during manufacturing or before / during a medical procedure) such that the needle is placed in a desired position (e.g., an axial position) relative to the coupling element. In this way, the needle can be bent at or along a predetermined and / or desired segment or length of the needle. In some embodiments, for example, the predetermined and / or desired segment or length of the needle can be based at least in part on the size and / or type of the needle, the medical procedure being performed or planned, the patient's anatomy, or the patient's expected anatomy, etc.

[0096] At 803, the needle is bent due to the segment where the coupling element engages the needle. In some embodiments, the transformation of the second housing segment and / or the positioning of the needle relative to the coupling element can allow the needle to be bent in a predetermined and / or desired manner or amount. For example, in some embodiments, the first housing segment and / or the second housing segment may include one or more shoulders that can selectively control and / or limit the relative movement between the first housing segment and the second housing segment, thereby controlling and / or limiting the amount or degree of bending along the segment of the needle. The above text describes the options and / or embodiments for controlling the amount, degree and / or position of bending along the needle with reference to specific embodiments. However, it should be understood that these options and / or embodiments are presented only as examples and not limitations. Other (multiple) features, (multiple) devices and / or (multiple) methods or combinations thereof for controlling and / or limiting bending along the needle may be possible.

[0097] At 804, after bending the needle, the second housing segment is allowed to transform (e.g., move, rotate, etc.) from the second configuration toward the first configuration relative to the first housing segment. In other words, after bending the needle, the second housing segment can be transformed back or allowed to transform back to a configuration that is not substantially moved or substantially rotated, wherein the second housing segment (or at least a portion or a central axis thereof) is aligned or substantially aligned with the first housing segment (or at least a portion or a central axis thereof). Thus, the needle bending assembly and / or its housing segments can be in a configuration similar or similar to the first configuration, but the needle disposed in the needle bending assembly is now bent. At step 805, the bent needle can be withdrawn from each of the first housing segment and the second housing segment of the needle bending assembly. For example, in some embodiments, the proximal end of the needle can be coupled to a needle seat and / or can extend distally from the needle seat, and the needle and needle seat together form a needle assembly. In such embodiments, the needle can be withdrawn from the housing segment by pulling and / or otherwise moving the needle seat in a proximal direction relative to the needle bending assembly.

[0098] In some embodiments, method 800 may include one or more additional (optional) steps. For example, at optional step 811, method 800 may include positioning (e.g., moving, advancing, retracting, rotating, adjusting, etc.) the needle to a selected position within and / or relative to the first housing segment and / or the second housing segment. In some embodiments, the needle bending assembly may include a window or other feature configured to allow a user to determine and / or visualize the tip of the needle (e.g., such as a window with respect to the needle). Fig.30In some embodiments, the selected position can be determined by the position of the distal tip of the needle as viewed through a window positioned along the second housing segment, such that bending of the needle occurs at or along a specified and / or desired needle segment and / or otherwise occurs at or along a desired length of the needle.

[0099] Additionally or alternatively, at optional step 812, method 800 may include adjusting the bending angle of the bent needle. For example, in some embodiments, the needle bending assembly includes a mechanism or device for adjusting the bending angle of the needle, such as Fig.29 and Fig.30 , and / or any other suitable mechanism or device included in the needle bending system 600 shown in FIG. Thus, the mechanism(s), device(s), dial(s), etc. may be transformed, moved, advanced, retracted, translated, rotated, and / or otherwise manipulated to, for example, adjust one or more shoulders of the needle bending assembly to at least partially control (e.g., increase or decrease) the bending angle of the needle when the second housing segment is transformed, moved, and / or rotated from the first configuration to the second configuration.

[0100] Furthermore, if the needle bending assembly includes Figure 22-24 If the first and second cavities are similar or substantially identical to the first and second cavities 313 and 333 shown in FIG, the method 800 may include rotating the bent needle to a position that allows the bent needle to be withdrawn from and / or through the first and second cavities (e.g., pulled in a proximal direction relative to the needle bending assembly) at optional step 813. For example, as described above with respect to Fig.23 As described above, the bending needle can be rotated about the longitudinal axis or X-axis by about 90 degrees. Additionally or alternatively, if the needle bending assembly includes a Fig.25 and Fig.26 If the first cavity 413 and the second cavity 433 shown in FIG. 8 are similar or substantially identical to the first cavity 413 and the second cavity 433 shown in FIG. 8 , the method 800 may include, at optional step 814, sliding the bent needle to a position that allows the bent needle to be withdrawn (e.g., pulled in a proximal direction relative to the needle bending assembly) from and / or through the first and second housing segments (or cavities thereof). For example, the bent needle can be slid or moved laterally (e.g., along the Z axis) within the first and second cavities to position the bent needle so that it can be pulled from the first and second housing segments.

[0101] Although various embodiments have been described and shown herein, a person of ordinary skill in the art will readily envision various other means and / or structures for performing functions and / or obtaining the results and / or one or more advantages described herein, and each of such variations and / or modifications is considered to be within the scope of the embodiments described herein. More generally, it will be readily understood by those skilled in the art that all parameters, dimensions, materials, and configurations described herein are presented only as examples, and actual parameters, dimensions, materials, and / or configurations may depend on one or more specific applications in which they are used. Those skilled in the art will recognize or be able to determine many equivalents to the specific embodiments described herein. Therefore, it should be understood that the aforementioned embodiments are presented only as examples, and that the embodiments may be practiced in a manner different from that specifically described and / or claimed.

[0102] Although embodiments have been described as having specific combinations of features and / or components, other embodiments may have any combination of features and / or components from any embodiment described herein, except mutually exclusive combinations. The embodiments described herein may include various combinations and / or sub-combinations of the functions, components and / or features of the different embodiments described.

[0103] The specific configuration of the various components may also be varied. For example, the sizes and specific shapes of the various components may differ from the illustrated embodiments while still providing the functionality described herein. More specifically, the sizes and shapes of the various components may be specifically selected for a desired or intended use. Therefore, it should be understood that the sizes, shapes, and / or arrangements of the embodiments and / or their components may be adapted to a given use unless the context clearly states otherwise.

[0104] In addition, various concepts can be embodied as one or more methods, wherein (multiple) examples are provided. The actions performed as part of the method can be ordered in any suitable manner. Therefore, embodiments can be constructed in which the actions are performed in a different order than shown, which can include performing some actions simultaneously or in parallel when possible, even if the actions are described and / or shown as sequential actions in certain embodiments.

Claims

1. A needle bending assembly configured to at least temporarily accommodate a needle, the needle bending assembly comprising: a first housing section defining a first cavity configured to at least temporarily receive a first section of the needle; a second housing segment defining a second cavity configured to at least temporarily receive a second segment of the needle forming a distal tip of the needle; as well as A coupling element is coupled between the first housing segment and the second housing segment such that when the needle is accommodated within the needle bending assembly, movement of the second housing segment relative to the first housing segment causes the needle to bend at a position corresponding to the coupling element.

2. The needle bending assembly of claim 1, wherein the first housing segment includes an inner surface defining at least a portion of the first cavity, the inner surface being configured to contact the first segment of the needle when the needle is received in the needle bending assembly. 3 . The needle bending assembly of claim 1 , wherein the second housing segment is configured to move through a predetermined range of motion relative to the first housing segment between a first configuration and a second configuration.

4. The needle bending assembly of claim 3, wherein the second housing segment includes an inner surface defining at least a portion of the second cavity, and When the needle is housed in the needle bending assembly, the inner surface is spaced apart from the second segment of the needle when the second housing segment is in the first configuration, and the inner surface is placed in contact with the second segment of the needle when the second housing segment is in the second configuration.

5. A needle bending assembly according to claim 1, wherein the connecting element includes a movable hinge, which connects the first shell segment to the second shell segment, and the movable hinge is configured to contact a third segment of the needle between the first segment and the second segment of the needle.

6. A needle bending assembly according to claim 5, wherein movement of the second shell segment relative to the first shell segment causes the needle to bend at a position along the third segment of the needle, and the fulcrum around which the needle is bent corresponds to the contact point between the movable hinge and the third segment of the needle.

7. The needle bending assembly of claim 5, wherein the first housing segment, the second housing segment, and the living hinge are integrally constructed.

8. The needle bending assembly of claim 1, wherein the first housing segment includes an inner surface defining at least a portion of the first cavity, the second housing segment includes an inner surface defining at least a portion of the second cavity, and when the needle is received in the needle bending assembly: an inner surface of the first housing section configured to contact the first section of the needle, When the second housing segment is in a first configuration relative to the first housing segment, an inner surface of the second housing segment is spaced apart from the second segment of the needle, and When the second housing segment is moved to a second configuration relative to the first housing segment, an inner surface of the second housing segment is placed in contact with a second segment of the needle, the contact being operable to bend the needle at a location corresponding to the coupling element, and An inner surface of the first housing segment and an inner surface of the second housing segment are shaped to allow the needle to be withdrawn from each of the first lumen and the second lumen after bending.

9. A needle bending system comprising: a needle assembly having a needle extending in a distal direction from a needle hub; as well as a needle bending assembly removably coupled to the needle assembly, the needle bending assembly comprising: a first housing section defining a first cavity that removably receives a first section of the needle, a second housing segment defining a second cavity that removably receives a second segment of the needle forming a distal tip of the needle, and A coupling element is configured to couple the first housing segment and the second housing segment such that movement of the second housing segment relative to the first housing segment causes the needle to bend at a position corresponding to the coupling element.

10. The needle bending system of claim 9, wherein the first housing segment includes an inner surface defining at least a portion of the first lumen, the inner surface selectively contacting the first segment of the needle.

11. The needle bending system of claim 9, wherein a distal portion of the needle hub is removably disposed in a proximal portion of the first lumen to removably couple the needle hub to the needle bending assembly, The inner surface defining the proximal portion of the first cavity forms a plurality of recesses, each of the plurality of recesses aligning with and receiving a portion of a unique one of the plurality of projections along the distal portion of the needle hub.

12. The needle bending system of claim 9, wherein the second housing segment is configured to move through a predetermined range of motion relative to the first housing segment between a first configuration and a second configuration.

13. A needle bending system according to claim 12, wherein the second shell segment includes an inner surface that defines at least a portion of the second cavity, when the second shell segment is in the first structure, the inner surface is spaced apart from the second segment of the needle, and when the second shell segment is in the second structure, the inner surface is placed in contact with the second segment of the needle.

14. A needle bending system according to claim 9, wherein the connecting element includes a movable hinge, which connects the first shell segment to the second shell segment, and the movement of the second shell segment relative to the first shell segment causes the needle to bend at a position along the third segment of the needle, and the fulcrum around which the needle is bent corresponds to the contact point between the movable hinge and the third segment of the needle between the first segment and the second segment of the needle.

15. The needle bending system of claim 9, wherein the first housing segment includes an inner surface that defines at least a portion of the first lumen, and the second housing segment includes an inner surface that defines at least a portion of the second lumen, The inner surface of the first housing section selectively contacts the first section of the needle, When the second housing segment is in a first configuration relative to the first housing segment, the inner surface of the second housing segment is spaced from the second segment of the needle, and when the second housing segment is moved to a second configuration relative to the first housing segment, the inner surface of the second housing segment is placed in contact with the second segment of the needle, the contact being operable to bend the needle at a position corresponding to the coupling element, and An inner surface of the first housing segment and an inner surface of the second housing segment are shaped to allow the needle to be withdrawn from each of the first lumen and the second lumen after bending.

16. A method of bending a needle using a needle bending assembly, the needle bending assembly comprising a first housing segment, a second housing segment, and a coupling element coupling the first housing segment to the second housing segment, the method comprising: transitioning the second housing section from a first configuration to a second configuration relative to the first housing section; causing a section of the needle between the housing sections to engage with the coupling element as a result of the transition; bending of the needle due to the coupling element engaging a section of the needle; subsequent to said bending, allowing said second shell segment to transition from said second configuration toward said first configuration; as well as A curved needle is withdrawn from each of the first housing section and the second housing section.

17. The method of claim 16, wherein the transitioning comprises bending the second housing segment through a predetermined rotational angle relative to the first housing segment and about a fulcrum defined by the coupling element.

18. The method of claim 17, wherein the predetermined rotation angle is greater than an angle along the bend of the needle.

19. The method of claim 16, wherein the coupling element is a living hinge that movably couples the first housing section and the second housing section.

20. The method of claim 16, wherein after allowing the second housing to transition toward the first configuration and before withdrawing the curved needle from each of the first housing segment and the second housing segment, the method further comprises: The bent needle in the needle bending assembly is repositioned to allow the bent needle to be withdrawn from each of the first housing segment and the second housing segment, the repositioning comprising at least one of rotating or sliding the bent needle relative to the needle bending assembly.

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