Devices, systems, and methods for needle alignment

Abstract

Disclosed herein is a needle alignment aid. The needle alignment aid can include an attachment mechanism operable to engage to a needle and a level bubble vial comprising a bubble. The bubble can be operable to indicate an orientation of the needle.

Description

PATENT -PCT Attorney Docket No. 108683-828339PC DEVICES, SYSTEMS, AND METHODS FOR NEEDLE ALIGNMENTCross-Reference to Related Applications

[0001] This application claims the benefit of U.S. Application No. 63 / 761,027, filed February 20, 2025, the entire contents of which are incorporated herein by reference in their entirety.Field of Disclosure

[0002] The present disclosure relates to needle alignment aid devices, systems, and methods of use thereof.Background

[0003] Many medical procedures require precise needle insertion to be successful. For example, in lumbar puncture procedures it is vital that the needle is inserted into the subarachnoid space. In order to reach the subarachnoid space, the angle of needle insertion must be precise. While needle insertion angles can be mastered over time by skilled physicians, many new physicians or healthcare professionals struggle with properly inserting the needle, thereby resulting in multiple punctures before a successful procedure is achieved.

[0004] Therefore, there is a need for a needle alignment aid which provides feedback on the needle tip angle.Summary

[0005] Provided herein is a device for aligning a needle. The device can include an attachment mechanism operable to engage to the needle and a level bubble vial including a bubble. The bubble can be operable to indicate an orientation of the needle.

[0006] In some aspects, the orientation can be an angle of the needle in relation to a horizontal surface. In some aspects, the bubble can be operable to ensure that the angle of the needle is aligned with a procedural insertion angle. In some aspects, the procedural insertion angle can be defined by the angle between a skin surface of a patient and the needle.109149391 1PATENT- PROV Attorney Docket No. 108683-828339

[0007] In some aspects, the skin surface can be a back of the patient. In some aspects, the procedural insertion angle can be about 90 degrees or perpendicular to the skin surface. In some aspects, the level bubble vial can further include one or more markings operable to provide a visual indication of the procedural insertion angle.

[0008] In some aspects, the orientation includes a vertical orientation of the needle in relation to a hand of the user. In some aspects, the attachment mechanism can include a clip operable to couple to the needle and / or a needle base.

[0009] Further provided herein is a method for verifying a procedural needle insertion angle. The method can include locating one or more landmarks on a skin surface of a patient, locating an insertion area based on the one or more landmarks, inserting a needle into the insertion area, and ensuring, via a needle alignment aid, that the needle is aligned with a procedural insertion angle. The needle alignment aid can include a level bubble vial including a bubble. The bubble can be operable to ensure that the needle is inserted at the procedural insertion angle.

[0010] In some aspects, the method can further include collecting spinal fluid from the patient via the needle. In some aspects, the procedural insertion angle can be defined by an angle between the skin surface of the patient and the needle. In some aspects, the skin surface is a back of the patient.

[0011] In some aspects, the procedural insertion angle is about 0 degrees to about 90 degrees and has an orientation of upward, downward, or level. In some aspects, the procedural insertion angle is about 90 degrees or perpendicular to the skin surface. In some aspects, the needle alignment aid is engaged to the needle via an attachment mechanism. In some aspects, the attachment mechanism is a clip operable to couple to the needle and / or a needle base. In some aspects, the level bubble vial further comprises one or more markings operable to provide a visual indication of the procedural insertion angle.

[0012] Further provided herein is a system for locating a procedural insertion angle of a needle in relation to a patient. The system can include a needle alignment aid. The needle alignment aid can include an attachment mechanism, a level bubble vial, and a needle. The level bubble vial can include a bubble. The attachment mechanism can be engaged to the needle such that the level bubble vial is parallel to the needle. In some aspects, the 2109149391 1PATENT- PROV Attorney Docket No. 108683-828339 level bubble vial can include one or more markings operable to provide a visual indication of the procedural insertion angle.Brief Description of Figures

[0013] The description will be more fully understood with reference to the following figures and graphs, which are presented as various embodiments of the disclosure and should not be construed as a complete recitation of the scope of the disclosure. It is noted that, for purposes of illustrative clarity, certain elements in various drawings may not be drawn to scale. Understanding that these drawings depict only exemplary embodiments of the disclosure and are not therefore to be considered limiting of its scope, the principles herein are described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0014] FIG. 1 illustrates an inter-vertebral space in one example.

[0015] FIG. 2 illustrates a needle alignment aid in one example.

[0016] FIG. 3 illustrates a needle alignment aid in one example.

[0017] FIG. 4 illustrates a needle alignment aid in one example.

[0018] FIG. 5 illustrates a needle alignment aid attached to a needle in one example.

[0019] FIGS. 6A-6C illustrate example orientations of a needle in one example.

[0020] FIG. 7 illustrates a needle alignment aid attached to a needle in one example

[0021] FIG. 8 illustrates a needle alignment aid attached to a needle in one example.

[0022] FIG. 9 illustrates a needle alignment aid attached to a needle in one example.

[0023] FIG. 10 illustrates a needle alignment aid attached to a needle in one example.

[0024] FIG. 11 illustrates a needle alignment aid attached to a needle in one example.

[0025] FIG. 12 illustrates a needle alignment aid attached to a needle in one example.

[0026] FIG. 13 illustrates a needle alignment aid attached to a needle in one example.

[0027] FIG. 14 illustrates a needle alignment aid attached to a needle in one example.

[0028] FIG. 15 illustrates a needle alignment aid attached to a needle in one example.

[0029] FIG. 16 illustrates a needle alignment aid attached to a needle in one example.

[0030] FIG. 17 illustrates a needle alignment aid attached to a needle in one example.

[0031] FIG. 18 illustrates a needle alignment aid attached to a needle in one example.

[0032] FIG. 19 illustrates a needle alignment aid attached to a needle in one example.

[0033] FIGS. 20A-20C illustrate insertion angles of a needle in various examples.3109149391 1PATENT- PROV Attorney Docket No. 108683-828339

[0034] FIG. 21 illustrates a flow chart of a method for verifying needle insertion angle in one example.

[0035] Reference characters indicate corresponding elements among the views of the drawings. The headings used in the figures do not limit the scope of the claims.Detailed Description

[0036] Various embodiments of the disclosure are discussed in detail below. While specific implementations are discussed, it should be understood that this is done for illustration purposes only. A person skilled in the relevant art will recognize that other components and configurations may be used without parting from the spirit and scope of the disclosure. Thus, the following description and drawings are illustrative and are not to be construed as limiting. Numerous specific details are described to provide a thorough understanding of the disclosure. However, in certain instances, well-known or conventional details are not described in order to avoid obscuring the description. References to one or an embodiment in the present disclosure can be references to the same embodiment or any embodiment; and such references mean at least one of the embodiments.

[0037] Reference to “one embodiment”, “an embodiment”, or “an aspect” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. The appearances of the phrase “in one embodiment” or “in one aspect” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others.

[0038] The terms used in this specification generally have their ordinary meanings in the art, within the context of the disclosure, and in the specific context where each term is used. Alternative language and synonyms may be used for any one or more of the terms discussed herein, and no special significance should be placed upon whether or not a term is elaborated or discussed herein. In some cases, synonyms for certain terms are provided. A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification including examples of any terms 4109149391 1PATENT- PROV Attorney Docket No. 108683-828339 discussed herein is illustrative only and is not intended to further limit the scope and meaning of the disclosure or of any example term. Likewise, the disclosure is not limited to various embodiments given in this specification.

[0039] As used herein, “about” refers to numeric values, including whole numbers, fractions, percentages, etc., whether or not explicitly indicated. The term “about” generally refers to a range of numerical values, for instance, ± 0.5-1%, ± 1-5% or ± 5-10% of the recited value, that one would consider equivalent to the recited value, for example, having the same function or result.

[0040] Additional features and advantages of the disclosure will be set forth in the description which follows, and in part will be obvious from the description, or can be learned by practice of the herein disclosed principles. The features and advantages of the disclosure can be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features of the disclosure will become more fully apparent from the following description and appended claims or can be learned by the practice of the principles set forth herein.

[0041] Provided herein are devices, systems, and methods for properly orienting and locating a needle for insertion into a patient. Needle insertion commonly requires a precise insertion angle to reach a specific location within a patient’s body. While many physicians develop a deep understanding of needle orientation over time, many new physicians and other medical professionals do not have the same level of experience. When needles are not inserted properly, patients can experience increased stress, as a mistake may cause the patient to question the physician or medical professional’s ability. Further, improperly inserted needles can cause excess sedation, over exposure to risks of sedation, delays in diagnosis of the required bodily fluid, delays in delivery of medicine, delays in surgical operation time, and waste of valuable medical equipment. Further, improperly inserted needles can cause complications for the patient including bleeding, injury to surrounding structures, and infections.

[0042] The needle alignment aid provided herein overcomes the gap in experience between skilled healthcare professionals and newer healthcare professionals. In some examples, the needle alignment aid can be used by healthcare professionals (e.g., physicians, nurses, nurse practitioners, physician’s assistants, and other healthcare 5109149391 1PATENT- PROV Attorney Docket No. 108683-828339 professionals that use needles). In some examples, the needle alignment aid is described in terms of use in a lumbar puncture procedure, although it will be appreciated that the needle alignment aid can be used to guide insertion angle in numerous other medical procedures. For example, the needle alignment aid described herein can be used in numerous and broad ranging needle alignment procedures such as peripheral, arterial, and central line placements, a wide variety of drain placements, targeted space diagnostic samples, and targeted space medication administration.

[0043] FIG. 1 illustrates an example environment for a lumbar puncture procedure. As illustrated, the needle must be correctly oriented to be inserted through the supraspinous ligament, the infraspinous ligament, the ligamentum flavum, the epidural space, the dura, and into the subarachnoid space, which contains cerebrospinal fluid (CSF) and cauda equina. During a lumbar puncture, the subarachnoid space must be reached by the needle in order to obtain a sample of the CSF. However, as illustrated, vertebrae can easily be unintentionally hit during insertion of the needle. The needle alignment aid provided herein provides a visual indication of the orientation of the needle, such that a healthcare professional can safely, accurately, and effectively reach the subarachnoid space.

[0044] FIGS. 2-4 illustrate an example of a needle alignment aid 100. The needle alignment aid 100 can include an attachment mechanism 102 and a level bubble vial 104. The level bubble vial 104 can be operable to provide an indication of an orientation of the needle. The level bubble vial 104 can include a bubble 106. In some examples, the bubble 106 can be an air bubble formed in a liquid 110 contained within the level bubble vial 104. In some examples, the liquid 110 can be alcohol, oil, or another liquid operable to allow the bubble 106 to move freely within the level bubble vial 104. In some examples, the liquid 110 can be mineral oil. In some examples, the liquid 110 can include a dye operable to provide a color to the liquid 110.

[0045] In some examples, the bubble 106 can be spherical. In some examples, the bubble 106 can be in the shape of a curved barrel. In some examples, the bubble 106 can be an ovoid. In some examples, the bubble 106 is hemispherical.

[0046] In some examples, the bubble 106 has a size. For example, when the bubble 106 is spherical, the bubble 106 can have a diameter of about 1 millimeter (mm) to about 56109149391 1PATENT- PROV Attorney Docket No. 108683-828339 mm. In some examples, when the bubble 106 is a curved barrel, the bubble 106 can have a length of about 1 mm to about 5 mm and a maximum height of about 1 mm to about 5 mm. In some examples, when the bubble 106 is an ovoid, the bubble 106 can have a length of about 1 mm to about 5 mm and a diameter of about 1 mm to about 5 mm. In some examples, when the bubble 106 is hemispherical, the bubble 106 can have a diameter of about 1 mm to about 5 mm. In some examples, a smaller bubble 106 can have a greater sensitivity than a larger bubble 106. In some examples, a larger bubble can be easier to see than a smaller bubble. In some examples, the bubble size is selected based on both a desired sensitivity and an ease of visual indication.

[0047] In some examples, the bubble 106 can have a diameter of about 4 mm to about 6 mm and a length of about 5.5 mm to about 6.5 mm. In some examples, the bubble 106 can have a diameter of about 6 mm and a length of about 6 mm to about 6.5 mm.

[0048] In some examples, the bubble vial 104 can have a diameter slightly larger than a diameter of the bubble 106. For example, the bubble vial 104 can have a diameter (e.g., outer diameter) about 0.1 mm to about 0.5 mm larger than a diameter of the bubble 106. In some examples, the bubble 106 can have a diameter of about 5.5 mm to about 6.5 mm and the bubble vial 104 can have a diameter of about 5.6 mm to about 7 mm. In some examples, the bubble 106 can have a diameter of about 6 mm and the bubble vial 104 can have a diameter of about 6.4 mm.

[0049] The needle alignment aid 100 can include an attachment mechanism 102. In some examples, the attachment mechanism 102 can be operable to engage a needle. In some examples, the attachment mechanism 102 can be operable to couple to the needle. In some examples, the attachment mechanism 102 can be operable to attach to the needle. While the attachment mechanism 102 is described herein as being operable to engage to a needle, it will be appreciated that the attachment mechanism 102 can also be operable to engage to a needle base or any other component of a needle device. The attachment mechanism 102 can be operable to attach to any type of needle. For example, as illustrated in FIGS. 7-19, the attachment mechanism can be operable to attach to a cross-flat needle base. As illustrated in FIG. 5, the attachment mechanism 102 can be operable to attach to a round needle base. It will be appreciated that the attachment mechanism 102 can be modified to engage to any needle type and / or any needle size.7109149391 1PATENT- PROV Attorney Docket No. 108683-828339

[0050] In some examples, the attachment mechanism 102 can secure the level bubble vial 104 in a fixed position in relation to the needle (e.g., level bubble vial 104 can be parallel to the needle). For example, the level bubble vial 104 does not move in relation to the needle when the attachment mechanism 102 is engaged, coupled, and / or attached to the needle. In some examples, the attachment mechanism 102 can be a clip. For example, the clip can have a slot having a diameter that is slightly less than a diameter of the needle. In this manner, the slot can friction fit onto the needle when a force is used to engage the clip the needle. In some examples, the attachment mechanism 102 can be sized such that the attachment mechanism 102 can engage to any sized needle.

[0051] FIGS. 2 and 4 illustrate a clip of an attachment mechanism 102 in one example. As illustrated, the clip can be triangle in shape with a slot at the end. FIG. 3 illustrates a clip of an attachment mechanism 102 in another example. As illustrated, the clip can have a cylindrical shape. The clip can have a slot along a length of the cylinder such that the needle can be received in the slot, thereby engaging the needle to the clip. The attachment mechanism 102 can be operable to engage to any type of needle, needle base, needle hub or needle component. Additionally, in some embodiments, the needle alignment aid 100 is configured to engage a portion of a syringe or an associated plunger.

[0052] In some examples, the attachment mechanism 102 can be another type of attachment mechanism. For example, the attachment mechanism 102 can be any kind of friction fit mechanism, magnetic attachment mechanism, snap fit mechanism, compression mechanism, threaded attachment mechanism, or other types of attachment mechanisms configured to engage to a needle.

[0053] In some examples, the needle alignment aid 100 can have an arm 112. The arm 112 can hold the level bubble vial 104 on a distal end 114. In some examples, the level bubble vial 104 can be removably coupled to the distal end 114 of the arm 112. For example, the distal end 114 of the arm can include a gap operable to receive a portion of the level bubble vial 104. In some examples, the gap can have an adjustable diameter (e.g., via a tightening mechanism) operable to secure and / or release the level bubble vial 104. In other examples, other types of attachment mechanisms (e.g., snap fit connectors, latches, etc.) can be used to removably couple the level bubble vial 104 to the distal end 114 of the arm 112. In this manner, the level bubble vial 104 can be removed from the 8109149391 1PATENT- PROV Attorney Docket No. 108683-828339 arm 112 and replaced by another level bubble vial 104. For example, it may be preferable to use a less sensitive level bubble vial 104 in some procedures and a more sensitive level bubble vial 104 in other procedures. By making the level bubble vial 104 removable from the arm 112, the level bubble vial 104 can be easily removed and replaced as needed.

[0054] The arm 112 can include the attachment mechanism 102 on a proximal end 116. In other examples, the attachment mechanism 102 can removably couple to the arm 112 at the proximal end 116. For example, the attachment mechanism 102 can have snap-fit mechanisms, magnets, or other coupling mechanisms configured to removable couple to the proximal end 116 of the arm. In some examples, the attachment mechanism 102 can be operable to connect to a specific needle size. For example, when the attachment mechanism 102 is a clip with a slot, the slot can be sized such that it will friction fit with a specific needle diameter. By making the attachment mechanism 102 removable from the arm 112, the attachment mechanism 102 can be removed and replaced depending on the diameter of the needle. In this manner, the needle alignment aid 100 can be operable to engage to any size needle.

[0055] In some examples, the level bubble vial 104 can include one or more markings 108(a), 108(b). The one or more markings 108(a), 108(b) can be operable to indicate an orientation of the level bubble vial 104 in relation to a horizon or a horizontal surface. For example, as illustrated in FIG. 3, the one or more markings 108(a), 108(b) can be placed such that when the bubble 106 is in between the one or more markings 108(a), 108(b), the level bubble vial 104 is level in relation to a horizontal surface. In some examples, the one or more markings 108(a), 108(b) can be operable to determine an angle of the level bubble vial 104 in relation to a horizontal surface. For example, the level bubble vial 104 can have one or more markings 108(a), 108(b) that indicate various angles (e.g., about ±5 degrees, about ±10 degrees, about ±15 degrees, about ±20 degrees, about ±25 degrees, about ±30 degrees, about ±35 degrees, about ±40 degrees, about ±45 degrees, about ±50 degrees, about ±55 degrees, about ±60 degrees, about ±65 degrees, about ±70 degrees, about ±75 degrees, about ±80 degrees, about ±85 degrees, about ±90 degrees, or any angle therebetween) of the level bubble vial 104 in relation to the horizontal surface. A positive angle indicates a needle orientation pointing upward from a 9109149391 1PATENT- PROV Attorney Docket No. 108683-828339 horizontal surface (e.g., the needle tip is higher off the ground than a base of the needle). A negative angle indicates a needle orientation pointing downwards from the horizontal surface (e.g., the base of the needle is higher off the ground than the tip). In some examples, when the one or more markings 108(a), 108(b) indicate an angle of the level bubble vial 104 in relation to a horizontal surface, the bubble 106 can be centered on one of the one or more markings 108(a), 108(b) when the level bubble vial 104 is at the angle indicated by the marking.

[0056] In some examples, the one or more markings 108(a), 108(b) are color coded to indicate the angle of the level bubble vial 104 in relation to the horizontal surface. For example, a certain color marking can indicate an angle of ±15 degrees, another color can indicate an angle of ±30 degrees, another color can indicate an angle of ±45 degrees, and so on. Other marking indicators can be used, such as a typed numeral or any other type of indicators.

[0057] In some examples, the needle alignment aid 100 can incorporate a different type of level device instead of, or in conjunction with, the bubble level vial 104. For example, the needle alignment aid 100 can include an electronic level or another level device operable to indicate an orientation of the needle.

[0058] FIG. 5 illustrates a needle alignment aid 100 engaged with a needle 200, collectively referred to as a system 301. As illustrated, the attachment mechanism 102 can engage to the needle 200 directly. In some examples, the attachment mechanism 102 can be configured to couple to another portion of the needle device (e.g., needle base). The level bubble vial 104 can be parallel to the needle 200, such that the orientation of the needle can be determined based on the orientation of the level bubble vial 104 (e.g., the needle 200 and the level bubble vial 104 will have the same orientation).

[0059] FIGS. 6A-6C illustrate three different orientations of the needle 200. FIG. 6A illustrates a level orientation of the needle 200 in relation to a horizontal surface 202 (e.g., a horizontal surface that is flat and parallel to flat ground). FIG. 6B illustrates a downward orientation of the needle 200 in relation to the horizontal surface 202. FIG. 6C illustrates an upward orientation of the needle 200 in relation to the horizontal surface 202. When the needle 200 has a downward orientation, the angle 204 between the needle 200 and the horizontal surface 202 can have a negative value. When the needle 200 has an 10109149391 1PATENT- PROV Attorney Docket No. 108683-828339 upward orientation, the angle 204 between the needle 200 and the horizontal surface 202 can have a positive value. When the needle 200 is level (e.g., parallel to) with the horizontal surface 202, the angle 204 can be 0 degrees.

[0060] FIG. 7 illustrates an upward orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is closer to a distal end 300 of the level bubble vial 104 than a proximal end 302 of the level bubble vial 104 indicating that the level bubble vial 104, and thereby the needle 200, has an upward orientation (e.g., positive angle) with respect to a horizontal surface.

[0061] FIG. 8 illustrates an upward orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is closer to a distal end 300 of the level bubble vial 104 than a proximal end 302 of the level bubble vial 104 indicating that the level bubble vial 104, and thereby the needle 200, has an upward orientation (e.g., positive angle) with respect to a horizontal surface. The upward orientation illustrated in FIG. 8 is greater (e.g., greater angle with respect to a horizontal surface) than the upward orientation illustrated in FIG. 7 because the bubble 106 is closer to the distal end 300 of the level bubble vial 104 in FIG. 8.

[0062] FIG. 9 illustrates a downward orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is near the proximal end 302 of the bubble level vial 104 indicating that the bubble level vial 104, and thereby the needle 200, has a downward orientation (e.g., negative angle) with respect to the horizontal surface.

[0063] FIG. 10 illustrates a downward orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is near the proximal end 302 of the bubble level vial 104 indicating that the bubble level vial 104, and thereby the needle 200, has a downward orientation (e.g., negative angle) with respect to the horizontal surface.

[0064] FIG. 11 illustrates a level orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is approximately equidistant between the distal end 300 and the proximal end 302 indicating that the level bubble vial 104, and thereby the needle 200, are level (e.g., 0 degree angle and / or no angle) with respect to the horizontal surface.

[0065] FIG. 12 illustrates an upward orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is closer to a distal end 300 of the level 11109149391 1PATENT- PROV Attorney Docket No. 108683-828339 bubble vial 104 than a proximal end 302 of the level bubble vial 104 indicating that the level bubble vial 104, and thereby the needle 200, has an upward orientation (e.g., positive angle) with respect to a horizontal surface.

[0066] FIG. 13 illustrates a downward orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is near the proximal end 302 of the bubble level vial 104 indicating that the bubble level vial 104, and thereby the needle 200, has a downward orientation (e.g., negative angle) with respect to the horizontal surface.

[0067] FIG. 14 illustrates a level orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is approximately equidistant between the distal end 300 and the proximal end 302 indicating that the level bubble vial 104, and thereby the needle 200, are level (e.g., 0 degree angle and / or no angle) with respect to the horizontal surface.

[0068] FIG. 15 illustrates an upward orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is closer to a distal end 300 of the level bubble vial 104 than a proximal end 302 of the level bubble vial 104 indicating that the level bubble vial 104, and thereby the needle 200, has an upward orientation (e.g., positive angle) with respect to a horizontal surface.

[0069] FIG. 16 illustrates a downward orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is near the proximal end 302 of the bubble level vial 104 indicating that the bubble level vial 104, and thereby the needle 200, has a downward orientation (e.g., negative angle) with respect to the horizontal surface.

[0070] FIG. 17 illustrates a level orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is approximately equidistant between the distal end 300 and the proximal end 302 indicating that the level bubble vial 104, and thereby the needle 200, are level (e.g., 0 degree angle and / or no angle) with respect to the horizontal surface.

[0071] FIG. 18 illustrates an upward orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is closer to a distal end 300 of the level bubble vial 104 than a proximal end 302 of the level bubble vial 104 indicating that the level bubble vial 104, and thereby the needle 200, has an upward orientation (e.g., positive angle) with respect to a horizontal surface.12109149391 1PATENT- PROV Attorney Docket No. 108683-828339

[0072] FIG. 19 illustrates a downward orientation of the needle 200 as indicated by the level bubble vial 104. As illustrated, the bubble 106 is near the proximal end 302 of the bubble level vial 104 indicating that the bubble level vial 104, and thereby the needle 200, has a downward orientation (e.g., negative angle) with respect to the horizontal surface.

[0073] The level bubble vial 104 can provide a visual indication of the orientation of the needle 200 such that a user can ensure that the needle 200 is properly oriented when inserted into a patient. By confirming the proper orientation of the needle 200, the user can ensure that the needle 200 reaches the proper location within the patient. In this manner, a user can properly locate the needle 200 in the patient’s body, thereby successfully performing the procedure and mitigating any unnecessary injury to the patient.

[0074] In some examples, the orientation of the needle 200 provided by the needle alignment aid 100 can also verify an insertion angle (e.g., procedural insertion angle) of the needle. FIGS. 20A-20C illustrate various insertion angles 400(a), 400(b), 400(c) of the needle 200 in relation to a skin surface 404 of a patient. As described herein, the angle 204 between the needle 200 and a horizontal surface 202 can be positive (upward orientation), negative (downward orientation), or 0 degrees (level). When the needle 200 is level with the horizontal surface 202, the insertion angle can be 0 degrees, as illustrated in FIG. 20A. When the needle 200 has an upward orientation with respect to the horizontal surface 202, the insertion angle 400(b) can be a value less than 90 degrees, as illustrated in FIG. 20B. When the needle 200 has a downward orientation with respect to the horizontal surface 202, the insertion angle 400(c) can be a value less than 90 degrees, as illustrated in FIG. 20C. In some examples, an upward orientation of the needle 200 in relation to the horizontal axis can have a positive value for insertion angle 400(b) and a downward orientation of the needle 200 in relation to the horizontal axis can have a negative value for the insertion angle 400(c). The positive value for insertion angle 400(b) can indicate that the needle is moving vertically upwards in relation to the horizontal surface 202 as the needle 200 is being inserted into the skin surface 404 of the patient. The negative value for insertion angle 400(c) can indicate that the needle is moving vertically downwards in relation to the horizontal surface 202 as the needle 200 is being inserted into the skin surface 404 of the patient.13109149391 1PATENT- PROV Attorney Docket No. 108683-828339

[0075] In some examples, the one or more markings 108(a), 108(b) can be used to mark insertion angles 400(a), 400(b), 400(c) with respect to a vertical plane defined by skin surface 404. In this manner, a user can ensure that the needle 200 is being inserted at the proper insertion angle 400(a), 400(b), 400(c) with respect to the vertical plane defined by the skin surface 404. For example, when the bubble 106 is centered on a marking 108(a), 108(b) indicating a specific insertion angle 400(a), 400(b), 400(c), the insertion angle 400(a), 400(b), 400(c) of the needle 200 into the skin surface 404 of the patient is confirmed. In some examples, the one or more markings 108(a), 108(b) can provide markings for both the angle 204 in relation to the horizontal surface 202 and for insertion angles 400(a), 400(b), 400(c) in relation to the vertical plane defined by the skin surface 404.

[0076] In some examples, the insertion angle 400(a) is 90 degrees. In some examples, the insertion angle 400(b) is about 0 degrees to about 5 degrees, about 5 degrees to about 10 degrees, about 10 degrees to about 15 degrees, about 15 degrees to about 20 degrees, about 20 degrees to about 25 degrees, about 25 degrees to about 30 degrees, about 30 degrees to about 35 degrees, about 35 degrees to about 40 degrees, about 40 degrees to about 45 degrees, about 45 degrees to about 50 degrees, about 50 degrees to about 55 degrees, about 55 degrees to about 60 degrees, about 60 degrees to about 65 degrees, about 65 degrees to about 70 degrees, about 70 degrees to about 75 degrees, about 75 degrees to about 80 degrees, about 80 degrees to about 85 degrees, or about 85 degrees to about 90 degrees. In some examples, the insertion angle 400(c) is about 0 degrees to about -5 degrees, about -5 degrees to about -10 degrees, about - 10 degrees to about -15 degrees, about -15 degrees to about -20 degrees, about -20 degrees to about -25 degrees, about -25 degrees to about -30 degrees, about -30 degrees to about -35 degrees, about -35 degrees to about -40 degrees, about -40 degrees to about -45 degrees, about -45 degrees to about -50 degrees, about -50 degrees to about -55 degrees, about -55 degrees to about -60 degrees, about -60 degrees to about -65 degrees, about -65 degrees to about -70 degrees, about -70 degrees to about -75 degrees, about -75 degrees to about -80 degrees, about -80 degrees to about -85 degrees, or about -85 degrees to about -90 degrees.14109149391 1PATENT- PROV Attorney Docket No. 108683-828339

[0077] In other examples, the insertion angle 400(b) can be given an indication of upward 1 degree to upward 89 degrees, or any value therebetween. Similarly, the insertion angle 400(c) can be given an indication of downward 1 degree to downward 89 degrees, or any value therebetween.

[0078] Different procedures can require different insertion angles to be successful. For example, in lumbar puncture procedures it is important that the needle 200 is level with the horizontal surface 202 and has an insertion angle 400(a) of 90 degrees in order to properly reach the subarachnoid space and retrieve CSF. In other procedures, such as central venous access procedures, the insertion angle is based on healthcare professional and / or patient positioning and may range between 15 degrees and 45 degrees.

[0079] While the level bubble vial 104 is described herein as being operable to determine an orientation with respect to a horizontal surface 202 and / or a skin surface 404, it will be appreciated that the level bubble vial 104 can also be configured to indicate other orientations with respect to other surfaces, such as a vertical orientation in relation to a hand of a user.

[0080] Further provided herein is a method for verifying a needle insertion. FIG. 21 illustrates the method 2100. At block 2102, the method 2100 can begin by locating one or more landmarks on a skin surface of a patient. In some examples, the one or more landmarks can be biological landmarks, such as vertebrae in a lumbar puncture. In some examples, the one or more landmarks can be measured landmarks based on imaging data from x-rays, CT scans, MRIs, PET scans, or other imaging data. The one or more landmarks can vary depending on the type of procedure. The procedure can be any type of procedure where a needle insertion angle is required. For example, the procedure can be any guided needle medical procedure, such as peripheral, arterial, and central line placements, a wide variety of drain placements, targeted space diagnostic sample, and targeted space medication administration.

[0081] At block 2104, the method 2100 can include locating an insertion area based on the landmarks. In some examples, the insertion area can be an area between two or more vertebrae in a lumbar puncture procedure. In some examples, the insertion area can be based on biological structures such as bones, muscles, veins, arteries, etc.15109149391 1PATENT- PROV Attorney Docket No. 108683-828339

[0082] At block 2106, the method 2100 can include inserting a needle into the insertion area. At block 2108, the method 2100 can include ensuring, via a needle alignment aid, that the needle is aligned with an insertion angle. In some examples, the needle alignment aid can be any of the needle alignment aids described herein. The needle alignment aid can include a level bubble vial comprising a bubble. The bubble can be operable to ensure that the needle is inserted at the insertion angle, as described herein. In some examples, the needle alignment aid can include an attachment mechanism as described herein. In some examples, the attachment mechanism can be a clip operable to engage, couple, or attach to the needle or the needle base as described herein. In some examples, the level bubble vial includes one or more markings operable to provide a visual indication of the insertion angle as described herein.

[0083] In some examples, during a lumbar puncture procedure, the method 2100 can further include collecting spinal fluid or CSF from the patient via the needle. In other examples, the method 2100 can include collecting another bodily fluid or delivering a therapeutic agent.

[0084] In some examples, the insertion angle is defined by an angle between the skin surface of the patient and the needle. In some examples, the insertion angle is about 0 degrees to about 90 degrees and has an orientation of upward, downward, or level. In some examples, the skin surface is a back of the patient. For example, in a lumbar puncture procedure, the skin surface is a back of the patient. When the procedure is a lumbar puncture procedure, the insertion angle can be about 90 degrees (perpendicular) in relation to the skin surface of the patient. In some examples, the insertion angle can be adjusted for during insertion. In some examples, even if the insertion angle is incorrect at an initial insertion, the healthcare professional can adjust for the initial incorrect insertion angle using the needle alignment aid. For example, the healthcare professional may know where the needle needs to be located to reach the desired location and can use the needle alignment aid to correctly angle the needle to the desired location during insertion.

[0085] The disclosures shown and described above are only examples. Even though numerous characteristics and advantages of the present technology have been set forth in the foregoing description, together with details of the structure and function of the present disclosure, the disclosure is illustrative only, and changes may be made in the 16109149391 1PATENT- PROV Attorney Docket No. 108683-828339 detail, especially in matters of shape, size and arrangement of the parts within the principles of the present disclosure to the full extent indicated by the broad general meaning of the terms used in the attached claims. It will therefore be appreciated that the examples described above may be modified within the scope of the appended claims.17109149391 1

Claims

PATENT- PROV Attorney Docket No. 108683-828339 ClaimsWhat is claimed is:

1. A device for aligning a needle, the device comprising:an attachment mechanism operable to engage to the needle; anda level bubble vial comprising a bubble;wherein the bubble is operable to indicate an orientation of the needle.

2. The device of claim 1 , wherein the orientation is an angle of the needle in relation to a horizontal surface.

3. The device of claim 2, wherein the bubble is operable to ensure that the angle of the needle is aligned with a procedural insertion angle.

4. The device of claim 3, wherein the procedural insertion angle is defined by the angle between a skin surface of a patient and the needle.

5. The device of claim 4, wherein the skin surface is a back of the patient.

6. The device of claim 4, wherein the procedural insertion angle is 90 degrees or perpendicular to the skin surface.

7. The device of claim 4, wherein the level bubble vial further comprises one or more markings operable to provide a visual indication of the procedural insertion angle.

8. The device of claim 1 , wherein the orientation includes a vertical orientation of the needle in relation to a hand of a user.

9. The device of claim 1 , wherein the attachment mechanism is a clip operable to couple to the needle and / or a needle base.

10. A method for verifying a procedural needle insertion angle, the method comprising:locating one or more landmarks on a skin surface of a patient;locating an insertion area based on the one or more landmarks;inserting a needle into the insertion area; and18109149391 1PATENT- PROV Attorney Docket No. 108683-828339 ensuring, via a needle alignment aid, that the needle is aligned with a procedural insertion angle,wherein the needle alignment aid includes a level bubble vial comprising a bubble, andwherein the bubble is operable to ensure that the needle is inserted at the procedural insertion angle.

11. The method of claim 10, the method further comprising collecting spinal fluid from the patient via the needle.

12. The method of claim 10, wherein the procedural insertion angle is defined by an angle between the skin surface of the patient and the needle.

13. The method of claim 12, wherein the skin surface is a back of the patient.

14. The method of claim 12, wherein the procedural insertion angle is about 0 degrees to about 90 degrees and has an orientation of upward, downward, or level.

15. The method of claim 12, wherein the procedural insertion angle is about 90 degrees or perpendicular to the skin surface.

16. The method of claim 10, wherein the needle alignment aid is engaged to the needle via an attachment mechanism.

17. The method of claim 16, wherein the attachment mechanism is a clip operable to couple to the needle and / or a needle base.

18. The method of claim 10, wherein the level bubble vial further comprises one or more markings operable to provide a visual indication of the procedural insertion angle.

19. A system for locating a procedural insertion angle of a needle in relation to a patient, the system comprising:a needle alignment aid comprising:an attachment mechanism; anda level bubble vial comprising a bubble; anda needle,19109149391 1PATENT- PROV Attorney Docket No. 108683-828339 wherein the attachment mechanism is engaged to the needle such that the level bubble vial is parallel to the needle, andwherein the bubble is operable to indicate an orientation of the needle.

20. The system of claim 19, wherein the level bubble vial comprises one or more markings operable to provide a visual indication of the procedural insertion angle.20109149391 1

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