WO2021150732A1 - Device for percutaneous puncture assistance - Google Patents

Abstract

A device to assist in percutaneous punctures. In an embodiment, the device comprises an upper component, a lower component, a coupling mechanism that couples the lower component to the upper component, and a tool holder. The upper component comprises a platform configured to support a medical instrument comprising a needle, and the lower component comprises one or more finger holes, wherein each of the one or more finger holes is configured to receive a human finger therethrough. The tool holder is configured to hold a tool at a position that, when the platform is supporting the medical instrument, is on an opposite side of a tip of the needle as the lower component.

Description

DEVICE FOR PERCUTANEOUS PUNCTURE ASSISTANCE

CROSS-REFERENCE TO RELATED APPLICATIONS

[1] This application claims priority to U.S. Provisional Patent App. No. 62/963,991, filed on January 21, 2020, which is hereby incorporated herein by reference as if set forth in full.

BACKGROUND

[2] Field of the Invention

[3] The embodiments described herein are generally directed to percutaneous puncture, and, more particularly, to a device that aids in the insertion of a needle into a patient’s skin.

[4] Description of the Related Art

[5] Percutaneous intervention is the foundation of minimally invasive procedures. In recent years, it has transformed the way medicine is practiced. Despite the introduction of visual technologies, such as ultrasonography, computerized tomography (CT), and magnetic resonance imaging (MRI) to precisely target deep anatomical structures, current methods of percutaneous needle puncture can be prone to error. Depending on the skill level of the practitioner, these methods can take more time and needle insertions than desired, which can lead to complications, such as arterial and venous hematoma, peripheral nerve lesions, and parenchymal injuries.

[6] For example, to reach a deep anatomical structure percutaneously, the practitioner is often required to palpate a pulsating structure (e.g., arterial vessel) or hold the skin with one hand, while simultaneously, with the other hand, inserting a needle of an instrument at an angle through the skin towards a projected site of the anatomical structure (e.g., following a real-time or previously recorded visual aid). In general, the needle is inserted at a preset angle and as close as feasible (e.g., within one centimeter) from the projected site of the anatomical structure. While a 45-degree angle is usually preferred when approaching a vessel or nerve structure, a parenchymal obstruction may be approached at a much sharper angle and virtually always with real-time imaging assistance. This dynamic procedure can be a difficult maneuver to achieve once - let alone, multiple times. Once the needle has punctured the skin, the practitioner must then hold the needle steady, while following a visual aid or the practitioner’s own tridimensional recollection of the target anatomical structure, until the target anatomical structure is reached. If the target anatomical structure is a vessel, the proper feedback of a successful procedure may be represented by arterial or venous blood filling a cavity of the instrument (e.g., barrel of a syringe).

[7] What is needed is an improved method for percutaneous puncture. In particular, one or more of the above problems could be alleviated by a device that is able to assist in consistently puncturing the skin at a chosen or optimum angle, enable movement of the needle in three-dimensional space, and/or aid the practitioner in moving the needle towards the target anatomical structure, while maintaining stability of the needle at the chosen or optimum angle.

SUMMARY

[8] Accordingly, a device for assisting percutaneous punctures is disclosed. In an embodiment, the device comprises: an upper component comprising a platform configured to support a medical instrument comprising a needle; a lower component comprising one or more finger holes, wherein each of the one or more finger holes is configured to receive a human finger therethrough; a coupling mechanism that couples the lower component to the upper component; and a tool holder configured to hold a tool at a position that, when the platform is supporting the medical instrument, is on an opposite side of a tip of the needle as the lower component. A cross section of the platform, in a plane that is perpendicular to a longitudinal axis of the platform, may be semi-circular. The lower component may comprise at least two finger holes. The lower component may consist of two finger holes. The tool may comprise an ultrasound probe.

[9] The tool holder may comprise at least one arm and a holding portion at a distal end of the at least one arm, wherein the at least one arm is fastened to a side of lower component. The at least one arm may be fastened to the lower component by a fastener that is configured to pivot, such that the tool holder is rotatable with respect to the lower component. The at least one arm may comprise a channel, wherein the at least one arm is fastened to the lower component by a fastener that is inserted through the channel and is configured to slide within the channel, such that a distance between the lower portion and the holding portion of the tool holder is adjustable. A side surface of the at least one arm may comprise a distance scale comprising a first plurality of markings that indicate a distance represented by each of a plurality of positions along the channel. The coupling mechanism may comprise at least one arm comprising a channel, and wherein the at least one arm is fastened to the upper component by a fastener that is inserted through the channel and is configured to slide within the channel. The channel may be curved, such that an angle between the lower component and the upper component is adjustable. A side surface of the at least one arm may comprise an angle scale comprising a second plurality of markings that indicate an angle represented by each of a plurality of positions along the channel. Each of the first plurality of markings may indicate a value A within a range of distances, wherein each value of A within the range of distances represents a different distance from an injection site, along a trajectory of the needle when the medical instrument is supported on the platform, to a center of the bottom of the tool when the tool is held in the tool holder, each of the second plurality of markings may indicate a value X within a range of angles of the platform relative to the lower component, and the first and second pluralities of markings may be positioned such that tan '(B/A)=X is satisfied for every value of A indicated by the first plurality of markings and every value of X indicated by the second plurality of markings, wherein B is a depth under the center of the bottom of the tool, when the tool is held in the tool holder, that satisfies A²+B²=C², wherein C is a length of a hypotenuse of a right triangle formed by A, B, and C.

[ 10] The upper component may be fixed, by the coupling mechanism, at an angle relative to the lower component.

[11] The upper component may comprise a track, wherein the platform is configured to slide longitudinally along the track. The platform may comprise a securing mechanism that is configured to secure the medical instrument to the platform. The upper component may comprise an adjustable stop that is configured to restrict the platform from sliding longitudinally along the track beyond a set position.

[12] The platform may comprise a channel within which the medical instrument slides; and a stop that prevents a body of the medical instrument from sliding beyond a position at a distal end of the platform.

[13] The tool holder may be integral with the coupling mechanism, wherein the integral tool holder and coupling mechanism comprises at least one arm comprising a channel, wherein the at least one arm is fastened to the upper component by a fastener that is inserted through the channel and is configured to slide within the channel, and wherein the channel is curved, such that an angle between the lower component and the upper component is adjustable. The lower component may be configured to rotate, relative to the tool holder and the upper component, around an axis extending between the lower component and the upper component. BRIEF DESCRIPTION OF THE DRAWINGS

[14] The details of the present invention, both as to its structure and operation, may be gleaned in part by study of the accompanying drawings, in which like reference numerals refer to like parts, and in which:

[15] FIG. 1 illustrates a perspective view of a device being used to assist a percutaneous puncture, according to an embodiment;

[16] FIGS. 2A-2F illustrate various views of a device for assisting percutaneous punctures, according to an embodiment;

[17] FIG. 3-6B illustrate various features of a device for assisting percutaneous punctures, according to embodiments; and

[18] FIGS. 7A-7E illustrate side views of devices for assisting percutaneous punctures, according to alternative embodiments.

DETAILED DESCRIPTION

[19] After reading this description, it will become apparent to one skilled in the art how to implement the invention in various alternative embodiments and alternative applications. However, although various embodiments of the present invention will be described herein, it is understood that these embodiments are presented by way of example and illustration only, and not limitation. As such, this detailed description of various embodiments should not be construed to limit the scope or breadth of the present invention as set forth in the appended claims.

[20] In an embodiment, a device for improving percutaneous punctures (e.g., for blood sampling of a deep anatomical structure) is disclosed. The device may aid a practitioner in both keeping the needle of an instrument steady during the procedure and maintaining ideal ergonometric coordination between the practitioner’s right and left hands. For example, the disclosed device can assist a medical practitioner or other user (collectively referred to herein as a “practitioner”) in accurately and efficiently puncturing a projected site of an anatomical structure with a needle of a syringe, catheter, or other medical instrument, while simultaneously palpating the pulsation of a radial artery with his or her fingers at a position that is distal to the insertion site of the needle (e.g., in front of the insertion site), and stably guiding the needle towards the anatomical structure while maintaining the desired or optimal angle of insertion. The disclosed device may also be configured to hold a visualization tool, such as an ultrasound probe, in a desired position during the procedure. Such assistance may result in fewer unnecessary movements and errors.

[21] In an embodiment, the device has a lower component that comprises a finger holder that provides the practitioner with stability and safety during use of the device. The finger holder may have at least two finger holes configured to receive two or more of the practitioner’ s fingers. For example, the finger holder may comprise or consist of two finger holes, configured to receive a pair of adjacent fingers, such as the practitioner’s middle and index fingers. Each finger hole may have a size or diameter that is based on the average diameter of the respective finger for which it was designed. In an embodiment, each finger hole could comprise a sponge or sponge-like material within the finger hole to enhance the fit of the finger hole around the practitioner’s finger. The practitioner may insert his or her fingers into the finger holders of the lower component, and hold the finger holder firmly against the skin of a patient. The finger holes may be parallel or non-parallel to each other. The lower component may be fixed or rotatable with respect to a vertical axis.

[22] The device may also have an upper component with a platform used to guide the syringe or catheter with the needle (collectively referred to herein as an “instrument”) towards the anatomical structure. Notably, a catheter with needle is generally the preferred instrument for use in percutaneous interventions and cannulations. The platform may have a semi-circular or circular cross section, extending from a proximal end to a distal end, that is sized or otherwise configured to receive and support the body of the instrument (e.g., syringe barrel or catheter). The platform may also have a finger guard affixed to one end. The finger guard may be adjustable. In an embodiment, the platform may comprise an attachment mechanism (e.g., a male/female T-track structure) that enables joinder of the instrument body to the platform so as to limit movement of the instrument body to a linear axis that is parallel to the longitudinal axis of the platform.

[23] The lower and upper components can be coupled or joined at an interface by a coupling mechanism, such as a joint (e.g., a ball-and-socket mechanism), magnetic forces, a wing screw within a channel, and/or the like. Where applicable, the friction at the interface may be set so that it is high enough to maintain a desired angle between the lower and upper components (e.g., between the finger holes and platform), but low enough that the upper component can be moved relative to the lower component in response to a minimal manual force applied by the practitioner. While the coupling mechanism preferably enables relative movement between the upper and lower components, in an alternative embodiment, the coupling mechanism may comprise a fixed structure that does not enable relative movement between the upper and lower components. In any case, upper component provides the practitioner with a platform on which the instrument body can be seated and stabilized at a desired angle with respect to the patient’s skin or anatomical structure, thereby reducing or eliminating undesired movement of the instrument. Thus, the device can improve the consistency in angle and stability of the instrument during any procedure involving insertion of a needle through a patient’s skin (e.g., for insertion or extraction of fluids and/or other substances and/or other forms of cannulation or intervention).

[24] The device may also have a tool holder that accommodates a tool near the insertion site of the needle of the instrument. For example, the tool may comprise the probe of a visualization tool, such as an ultrasound probe for an ultrasound system that non-invasively senses and displays anatomical structures under the skin. The tool holder may releasably fix the tool at a position on an opposite side of the insertion site and needle tip as the lower and upper components. Thus, the tool can be used to visualize an area under the skin that is along the needle’ s forward trajectory during a percutaneous puncture. The proper angle of the needle and/or distance between the needle and tool can be determined and set, prior to insertion, using, for example, trigonometric functions, and optionally aided by scale markings on the device.

[25] Advantageously, the disclosed device may reduce unwanted movements, decrease the risk of the needle missing the desired puncture site on the patient or the anatomical structure within the patient, and/or decrease the risk of injuring surrounding structures. In addition, by keeping the needle still during extraction, the size of the percutaneous puncture can be reduced, since less movement will be present to stretch the puncture. Furthermore, the coupling mechanism between the upper and lower components may allow the practitioner to selectively move the instrument in any direction while inserted and while still maintaining a certain angle. This enables the practitioner to search for an anatomical structure (e.g., artery), if needed, without having to pull out and reinsert the needle into the skin.

[26] 1. Example Embodiment

[27] FIG. 1 illustrates a perspective view of a device 100 being used to assist a percutaneous puncture, according to an embodiment. In addition, FIG. 2A illustrates a top perspective view of device 100, FIG. 2B illustrates a top plan view of device 100, FIGS. 2C and 2D illustrate opposite side views of device 100, FIG. 2E illustrates a front view of device 100 (i.e., facing a distal end), and FIG. 2F illustrates a rear view of device 100 (i.e., facing a proximal end), according to an embodiment. [28] In FIG. 1, device 100 is illustrated on a practitioner’s hand and with an instrument 10 having a needle 12 for insertion into a patient’s skin 20. Advantageously, device 100 stabilizes instrument 10, for example, during a percutaneous puncture. Device 100 comprises a lower component 120 and an upper component 130, coupled by a coupling mechanism 110. Lower component 120 enables the practitioner to stably and safely hold instrument 10 as it is supported by upper component 130. In practice, a practitioner may rest lower component 120 on the body of the patient (e.g., the patient’ s forearm), during the procedure, in order to stabilize device 100.

[29] In the illustrated embodiment, lower component 120 comprises a finger holder with two finger holes 122 A and 122B. As illustrated, finger holes 122 may be circular in cross section to accommodate the typical human finger. However, finger holes 122 could have a different cross-sectional shape (e.g., oval, triangle, square, rectangle, pentagon, hexagon, heptagon, octagon, or any other multi-sided polygon). In addition, in an alternative embodiment, the finger holder could be replaced with any other structure that assists a practitioner in anchoring device 100 to a patient’s body.

[30] As an example, finger hole 122 A may be designed for a practitioner’ s middle finger, and finger hole 122B may be designed for a practitioner’s index finger. The diameter of each finger hole 122 may be designed based on the average diameter for the particular finger that it was designed to receive, such that different finger holes 122 may have different diameters. For example, finger hole 122A, which is designed to slide over the practitioner’s middle finger, may have a smaller diameter than finger hole 122B, which is designed to slide over the practitioner’s index finger. In this case, device 100 may be manufactured in both right-handed and left-handed embodiments. Alternatively, all finger holes 122 may have the same diameter based on the average diameter of the fingers that they were designed to receive. In this case, the same device 100 may be used by both right-handed and left-hand practitioners. In either case, device 100 may be manufactured in different sizes, such as a small size (e.g., with finger holes 122 having a diameter that is smaller than the average diameter of human fingers), a medium size (e.g., with finger holes 122 having a diameter that is equal to the average diameter of human fingers), and a large size (e.g., with finger holes 122 having a diameter that is larger than the average diameter of human fingers).

[31] While the illustrated embodiment consists of only two finger holes 122, it should be understood that alternative embodiments may comprise one, three, four, or five finger holes 122. However, device 100 preferably has at least two finger holes 122 to provide more stability over an embodiment with only a single finger hole 122, which could allow inadvertent rotation of the finger holder around the practitioner’s finger. In addition, an embodiment that consists of only two finger holes 122 may be preferable, since it may fit a wider range of practitioners’ hand sizes than embodiments with three or more finger holes 122. Thus, two finger holes 122 appropriately balances stability with flexibility.

[32] Furthermore, while finger holes 122 are illustrated as receiving the middle finger (e.g., third finger) and index finger (e.g., second finger) of a practitioner, finger holes 122 may be configured to receive different fingers. For example, finger hole 122 A may be designed to receive the fourth finger (e.g., the ring finger) while finger hole 122B may be designed to receive the middle finger. However, the middle and index fingers may provide the greatest stability and control for the majority of practitioners.

[33] The length of finger holes 122 may be designed so that a substantial portion of the practitioner’s finger extends out of the distal end of each finger hole 122. For example, the length of each finger hole 122 may be less than or equal to the length of the average person’s proximal phalanx (i.e., from the first knuckle, joining the hand to the finger, to the second knuckle) on the respective finger. This enables the practitioner to bend his or her finger at the second and third knuckles, so that, for example, the practitioner can feel the patient’s pulse using the same fingers that are extending through finger holes 122. Each finger hole 122 can have the same length or have different lengths, for example, corresponding to the average length of the proximal phalanx of the finger for which the finger hole 122 is designed, the average position of the second knuckles of the fingers relative to each other, or to provide one finger with more mobility than another finger (e.g., with shorter lengths representing more mobility, and greater lengths representing less mobility). Thus, finger hole 122A (e.g., for the middle finger) may be shorter than finger hole 122B (e.g., for the index finger), finger hole 122A may be longer than finger hole 122B, or finger hole 122A may be substantially the same length as finger hole 122B.

[34] In an embodiment, one or more of finger holes 122 may be tapered on at least one end and/or non-tapered on at least one end. For example, in the illustrated embodiments, finger holes 122 are both non-tapered on the proximal ends (i.e., closer to the first knuckle) and tapered on their distal ends (e.g., farther from the first knuckle). Alternatively, each finger hole 122 could be tapered on both the proximal end and distal end, non-tapered on both the proximal end and distal end, or tapered on the proximal end and non-tapered on the distal end. Furthermore, the proximal and/or distal ends of different finger holes 122 could be tapered and/or non-tapered differently from other finger holes 122. The tapering may be in any direction. For example, in the embodiment illustrated in FIG. 1, finger holes 122 have a greater length at the bottom of finger holes 122 (e.g., farther from upper component 130) and taper to a smaller length at the top of finger holes 122 (e.g., closer to upper component 130). Alternatively, as illustrated in FIGS. 2A-2F, the tapering could comprise a smaller length at the bottom of finger holes 122 that tapers to a greater length at the top of finger holes 122. The direction of tapering in FIGS. 2A-2F may be preferable over the direction of tapering in FIG. 1, because it better enables the practitioner’s fingers to bend downward at the knuckles (e.g., second and third knuckles), for example, to take a patient’s pulse, while simultaneously covering and thereby protecting the practitioner’s knuckles from needlestick injuries by needle 12

[35] Upper component 130 of device 100 may comprise a platform 132 that is configured to guide an instrument 10 during a procedure. Specifically, instrument 10 rests stably on platform 132 and can slide towards a distal end D to puncture a patient’s skin 20 with needle 12 at a desired angle and insertion site. In the illustrated embodiment, platform 132 is formed as a portion of a tube or cylinder having a substantially semi-circular or U-shaped cross section, in a plane that is orthogonal to the longitudinal axis of platform 132, extending from proximal end P (e.g., closer to the practitioner and farther from needle 12 during use) to distal end D (e.g., farther from the practitioner and closer to needle 12 during use). Alternatively, platform 132 could be a tube or cylinder having a substantially circular cross section, with the disadvantage that platform 132 may not be able to accommodate as many different sizes of instruments 10 as an embodiment with a substantially semi-circular cross section. In such an embodiment, the diameter of the circular cross section at one end of platform 132 may be the same or different than the diameter of the circular cross section at the opposite end of platform 132. As yet another alternative, the cross section of platform 132 may have a shape that is not semi-circular or circular, such as a triangle, square, rectangle, pentagon, hexagon, heptagon, octagon, or any other multi-sided polygon, or a portion (e.g., half) of any such shapes. As used herein, “semi-circular” or “circular” may also refer to a semi-ovular or ovular shape. In addition, “semi-circular” should be understood to include a cross section that is an arc forming half of a circle or oval, less than half of a circle or oval, or slightly more than half of a circle or oval.

[36] The length of platform 132 (i.e., the distance from the edge of proximal end P to the edge of distal end D) may be based on the length of the instrument(s) 10 which platform 132 is intended to support. In other words, the length of platform 132 may be chosen to stably support a single size of instrument 10 or a plurality of different sizes of instruments 10, so as to prevent instrument 10 from wobbling or tipping off the proximal end P or distal end D of platform 132.

[37] Similarly, the radius, width, and/or depth of the cross section of platform 132 may be chosen to stably support a single diameter of instrument 10 or a plurality of different diameters of instruments 10 (e.g., to prevent instrument 10 from rolling laterally within or off of platform 132). For example, the inner radius of the semi-circular cross section may be greater than or equal to the outer radius of an instrument 10 to be used and wide enough to encompass the full diameter or a substantial portion of the diameter of the instrument 10 to be used.

[38] However, it should be understood that platform 132 may be implemented with any length or cross-sectional shape that is suitable to for the instrument 10 or other medical instrument to be supported on platform 132. For example, the length of platform 132 may be based on the length of the instrument 10 to be used, and the cross section of platform 132 may substantially match at least a portion of the cross section of the instrument 10 to be used. In this manner, platform 132 may be designed to accommodate any variety of different shapes and sizes of instruments 10.

[39] In an embodiment, the top surface of platform 132 that interfaces with and contacts instrument 10 may be textured or made of or coated with a material or substance designed to increase friction between the surface and instrument 10. For example, the surface may be made of or coated with a material or substance that has a stickiness configured to lightly, releasably, and temporarily hold instrument 10. The texturing or coating may be provided across the whole top surface of platform 132 or just one or more partial regions of the top surface of platform 132. The increase in friction can improve the stability of instrument 10, which can be especially helpful when the practitioner is performing a procedure under significant stress (e.g., with trembling hands), such as during an emergency.

[40] Upper component 130 of device 100 may also comprise a finger guard 134 that extends downward at an angle from platform 132 at or near distal end D. Finger guard 134 protects the practitioner’s fingers from injury from inadvertent needlesticks from needle 12. For example, finger guard 134 separates a region in which the distal ends of practitioner’s fingers are present (e.g., extending from finger holes 122) and a region in which needle 12 is present, in order to prevent contact between the practitioner’s fingers and needle 12. Finger guard 134 should be configured to protect the practitioner’s fingers at all orientations and relative angles of platform 134. To this end, finger guard 134 may be varied in size, shape, width, and/or length, for a given application, to maximize protection of the practitioner’s fingers. Furthermore, finger guard 134 may extend from platform 132 at any suitable angle (e.g., in a range of greater than 0 degrees and less than 90 degrees), depending on the intended application. For example, finger guard 134 may extend from platform 132 at an approximate 45-degree angle. As another example, finger guard 134 may extend from platform 132 at an approximate 90-degree angle. As yet another example, finger guard 134 may extend parallel with platform 132 and needle 12 at a 0-degree angle, to allow the practitioner’s fingers to safely rest in close proximity to needle 12 (i.e., without touching or coming into the path of needle 12).

[41] In an embodiment, finger guard 134 may be pivotally connected to platform 132, so that the angle between finger guard 134 and platform 132 may be manually adjusted through a range of varying degrees. For example, finger guard 134 may be adjustable from a range of 0 degrees (e.g., substantially parallel to the bottom surface of platform 132) to 90 degrees (e.g., substantially perpendicular to the bottom surface of platform 132). Thus, a practitioner may adjust finger guard 134 to any inclination that corresponds to the practitioner’s preferred angle.

[42] Additionally or alternatively, finger guard 134 may be attachable and detachable from platform 132. In such an embodiment, a practitioner could detach finger guard 134 from platform 132 if desired (e.g., for improved maneuvering) or attach finger guard 134 to platform 132 if desired (e.g., for improved safety). In addition, the practitioner could switch a plurality of finger guards 134 in or out, as needed or desired. For example, a practitioner with larger fingers could replace a smaller finger guard 134 with a larger finger guard 134 for added protection, or could replace a larger finger guard 134 with a smaller finger guard 134 for additional maneuverability.

[43] In an embodiment, lower component 120 and upper component 130 are coupled together via coupling mechanism 110. In the embodiment illustrated in FIGS. 1-2F, coupling mechanism 110 comprises a ball-and-socket mechanism. Specifically, a ball-and-rod portion 112 is movably joined to a socket portion 114 by inserting the ball at the end of the rod of ball- and-rod-portion 112 into a socket of socket portion 114. The socket of socket portion 114 allows the ball of ball-and-rod portion 112 to rotate freely, through a substantially hemispherical range of positions, in three-dimensions within the socket. In an embodiment, socket portion 114 may allow rotation of ball-and-rod portion 112, such that upper component 130 may be rotated in 360 degrees in a horizontal plane. Alternatively, coupling mechanism 110 could be designed to restrict rotation of upper component 130 to a range that is less than 360 degrees in the horizontal plane, for example, to prevent syringe needle 12 from facing the practitioner. Similarly, socket portion 114 may also enable rotation of ball-and-rod portion 112, such that upper component 130 may be rotated in 180 degrees in a vertical plane, or restrict rotation of upper component 130 to a range that is less than 180 degrees in the vertical plane.

[44] While ball-and-rod portion 112 extends from upper component 130 and socket portion 114 extends from lower component 130 in the illustrated embodiment, these portions may be reversed in an alternative embodiment, such that ball-and-rod portion 112 extends from lower component 120 and socket portion 114 extends from upper component 130. Thus, no specific distinction is made as to which component corresponds to the male portion of the ball- and-socket mechanism and which component corresponds to the female portion of the ball- and-socket mechanism.

[45] The socket of socket portion 114 may receive the ball of ball-and-rod portion 112 in an interference fit. Thus, the ball-and-socket mechanism exhibits a degree of friction between socket portion 114 and ball-and-rod portion 112. In an embodiment, this degree of friction is sufficiently high to maintain a desired angle of platform 132, with minimal to no movement of platform 132, while instrument 10 is being supported by platform 132. In other words, the degree of friction should be such that, even when instrument 10 is being held on platform 132, platform 132 does not move, relative to any other component of device 100, unless the practitioner intentionally applies a manual force to platform 132. Of course, platform 132 may still move along with device 100, for example, as the practitioner moves his or her hand or fingers. It should be understood that, as used herein, the “angle” of platform 132 may refer to the angle of the longitudinal axis of platform 132 relative to lower component 120, the practitioner’s fingers, the patient, or the insertion site of needle 52 into the patient’s skin 20.

[46] In an alternative embodiment, coupling mechanism 110 may be implemented with a magnet. For example, instead of or in addition to a ball-and-socket mechanism, one or both of portion 112 on upper component 130 and portion 114 on lower component 120 may comprise a magnet that attracts a magnet or metallic surface of the other portion to hold the adjacent portions together, while still permitting mobility between the two portions 112 and 114. The strength of the magnet(s) may be selected as appropriate to achieve the desired mobility between portions 112 and 114. In further alternative embodiments, coupling mechanism 110 may comprise a twist-lock coupling, bolt-nut coupling, bendable coupling (e.g., rubber-coated wire), and/or the like. As yet another alternative, lower component 120 and upper component 130 may be one continuous structure, with platform 132 of upper component 130 having a fixed angle relative to lower component 120. [47] 2. Alternative Features

[48] FIGS. 3-6B illustrate various alternative features of device 100. Specifically, FIG. 3 illustrates a perspective view of the de-coupled components of device 100, FIGS. 4 and 5 illustrate side views of device 100, and FIGS. 6 A and 6B illustrate rear perspective views of alternative devices 100, according to various alternative embodiments. It should be understood that not all embodiments are described herein, and that embodiments may comprise any combination of any of the features described with respect to any of the embodiments described herein. For example, the fact that a first feature may be described with respect to an embodiment that comprises a second feature does not mean that all embodiments with the first feature must also comprise the second feature, or vice versa. Rather the first feature may be combined, with or without the second feature, with any other feature in any other embodiment to create an embodiment that is not explicitly described herein. In addition, the first feature may be omitted entirely from an embodiment or used on its own (i.e., without any other described features) in an embodiment.

[49] In the embodiment illustrated in FIG. 3, lower component 120 comprises an annular grip 124 within each finger hole 122. Each annular grip 124 is tubular or substantially cylindrical with an outer diameter that corresponds to the inner diameter of its respective finger hole 122. Annular grip 124 may be made from a soft or compressible (e.g., sponge or sponge like) material, such as rubber or similar material. The inner diameter of each annular grip 124 may be sized according to the average diameter of the finger which the annular grip 124 is intended to receive. For example, the inner diameter of each annular grip 124 may be slightly smaller than the average diameter of the finger which the annular grip 124 is intended to receive. Thus, as a practitioner inserts his or her finger into a given finger hole 122, the material of annular grip 124 in that finger hole 122 may compress outwards, such that when the practitioner’s finger is received within finger hole 122, annular grip 124 surrounds the finger to form a tight, friction fit around the finger. In this manner, annular grips 124 enable finger holes 122 to securely accommodate a wide range of different finger diameters. Annular grips 124 may be fixed within their respective finger holes 122 via adhesive and/or another fixation mechanism. It should be understood that the inner and/or outer diameters of each annular grip 124 may be different than the inner and/or outer diameters of the other annular grip(s) 124, because each annular grip 124 may be sized to fit a different finger and/or fit within a differently sized finger hole 122. For example, annular grip 124A may have smaller inner and outer diameters than annular grip 124B, larger inner and outer diameters than annular grip 124B, a smaller inner diameter but larger outer diameter than annular grip 124B, or a larger inner diameter but smaller outer diameter than annular grip 124B.

[50] Notably, platform 132 of the embodiment illustrated in FIG. 3 also has a thinner cross section and greater inner radius than the embodiments illustrated in FIGS. 1-2F. Accordingly, device 100 in FIG. 3 may support an instrument 10 with a larger diameter than device 100 in FIGS. 1-2F. It should be understood that the inner and/or outer radiuses of different embodiments of platform 132 in device 100 may be selected to fall within any practical range according to the size of instrument 10 that device 100 is intended to support. Generally, a platform 132 with an inner radius that closely matches the outer radius of the intended instrument 10 will provide greater stability and control during insertion of needle 12. The size and shape of platform 132 may also be dictated by the procedure to be performed. For example, different procedures may require greater levels of stability and/or control.

[51] FIG. 3 also illustrates a slightly different socket portion 114 for coupling mechanism 110 than the socket portion 114 illustrated in FIGS. 1-2F. Specifically, socket portion 114 in the embodiment illustrated in FIG. 3 has a lower profile, but is still shaped and sized to stabilize upper component 130 while enabling flexible control of the relative angle of upper component 130. It should be understood that many other variations of the ball-and- socket mechanism of coupling mechanism 110 and many other variations of coupling mechanism 110 itself are possible, as long as coupling mechanism 110 is structurally capable of stably supporting upper component 130. It should also be understood that many variations of lower component 120, including omission of lower component 120 entirely, are possible. However, it is preferable to have a lower component 120 that can at least rest against a patient’s body (e.g., forearm) to help stabilize platform 132 of upper component 130, while enabling the practitioner to complete the relevant procedure (e.g., any procedure using instrument 10) safely and effectively.

[52] In the embodiment illustrated in FIG. 4, coupling mechanism 110 is a structure that fixes the orientation and angle of upper component 130 relative to lower component 120. Thus, unlike the previously described embodiments, platform 132 of upper component 130 cannot be rotated with respect to lower component 120. However, in this embodiment, coupling mechanism 110 may still allow platform 132 to slide along the longitudinal axis defined by distal end D and proximal end P. Thus, a practitioner may slide platform 132 towards a patient (i.e., in the direction of distal end D) or away from the patient (i.e., in the direction of proximal end P). The length of coupling mechanism 110, defining the distance between lower component 120 and upper component 130, may be set to achieve any desired angle for instrument 10. For example, a coupling mechanism 110 with a shorter length will generally achieve a more obtuse angle (e.g., flatter approach with respect to the insertion site), whereas a coupling mechanism 110 with a greater length will generally achieve a more acute angle (e.g., higher angle with respect to the insertion site).

[53] In addition, platform 132 in the embodiment illustrated in FIG. 4 has a cross section that varies from distal end D to proximal end P. Specifically, platform 132 has a deeper cross section at its distal end D than at its proximal end P. For example, at distal end D, the cross section of platform 132 may be almost circular (e.g., crescent shaped) or substantially circular, whereas at the proximal end P, the cross section of platform 132 may be semi-circular. Consequently, as illustrated in FIG. 4, the sides of platform 132 are tapered from a shallower cross section at proximal end P to a deeper cross section a distal end D. This configuration enables more flexibility in the movement of instrument 10 as instrument 10 is inserted into platform 132 (i.e., due to the shallowness of platform 132 at proximal end P), while fully limiting instrument 10 once instrument 10 has been completely inserted into platform 132 (i.e., due to the depth of platform 132 at distal end D).

[54] In the embodiment illustrated in FIG. 5, finger guard 134 is substantially parallel to the longitudinal axis of platform 132. Notably, there is a distance G between the distal end of lower component 120 and the distal end of finger guard 134, which may be increased or decreased by adjusting upper component 130 relative to lower component 120 via coupling mechanism 110. The range of distance G may be set so as to comfortably accommodate the average finger size while allowing the fingers within finger holes 122 of lower component 120 to perform actions, such as taking the patient’s pulse during a procedure.

[55] In the embodiments illustrated in FIGS. 6A and 6B, platform 132 comprises an attachment mechanism 600. As shown, attachment mechanism 600 may comprise a T-track structure with a T-shaped track or rail, referred to herein as the “male” portion, and a “female” portion that receives and holds onto the T-shaped track, so as to slide along the T-shaped track. In the illustrated embodiment, the male portion is integrated into platform 132, and the female portion is attached to instrument 10. Thus, a practitioner may slide the female portion of instrument 10 onto the male portion (e.g., T-shaped track) of platform 132. In an alternative embodiment, the female portion may be integrated into platform 132, and the male portion may be attached to instrument 10. In other alternative embodiments, a different attachment mechanism 600 may be used to releasably attach instrument 10 to platform 132, including track-based mechanisms and non-track-based mechanisms. [56] In any case, attachment mechanism 600 allows the instrument 10 to be attached and detached from platform 132. Attachment mechanism 600 is configured to, when instrument 10 is attached to platform 132, restrict the movement of instrument 10 to a linear movement along or parallel to the longitudinal axis of platform 132. In other words, attachment mechanism 600 guides instrument 10 along a linear path on platform 132 in either the proximal or distal direction. For example, attachment mechanism 600 locks or secures the downward path of instrument 10 during insertion of instrument 10 into the patient’s skin 20. This restriction of movement can provide greater stability, control, and safety. After a procedure, the practitioner may remove instrument 10 by decoupling the components of attachment mechanism 600 (e.g., sliding the female portion off of the track or other male portion).

[57] In an embodiment, finger hole(s) 122 may be sized, shaped, and/or otherwise configured to accommodate multiple fingers. For example, instead of a plurality of finger holes, each configured to receive a single finger, lower component 120 may comprise one or more finger holes that are each configured to receive two or more fingers. For example, as illustrated in FIG. 6B, lower component 120 could consist of a single finger hole 122 that is sized and shaped to receive an average pair of middle and index fingers. In such an embodiment, the finger hole 122, which is configured to receive a plurality of fingers, may comprise semi-circular partitions to separate the individual fingers, or may comprise no partitions as illustrated in FIG. 6B.

[58] In an embodiment (not shown), device 100 may comprise a lower component 120 that has no holes or no holes configured to receive a finger. In this case, lower component 120 can comprise any apparatus that helps a practitioner to feel and/or locate a patient’s pulse. As another alternative, lower component 120 may be omitted from device 100 altogether. In this case, device 100 may comprise or consist of upper component 130 and use anatomic landmarks to determine the insertion site for needle 12.

[59] 3. Tool Accommodation

[60] FIGS. 7A-7E illustrate alternative embodiments of device 100 that are configured to accommodate an additional tool, such as an ultrasound probe or other visualization tool. These alternative embodiments may further augment the puncture assistance of previously described embodiments by facilitating the use of an additional tool 30 in conjunction with device 100. For example, additional tool 30 may comprise a probe that non-invasively senses the internal anatomical structures underneath the patient’s skin. An example of such a tool is an ultrasound probe that uses ultrasound to detect internal anatomical structures. Device 100 may be configured to hold tool 30, such that, as the practitioner moves device 100, tool 30 moves with device 100 in a fixed position relative to device 100. In the case of a visualization tool, tool 30 may be positioned near and forward of the tip of needle 12, such that it senses the anatomical structures along the forward trajectory of needle 12. In the event that tool 30 is a visualization probe, such as an ultrasound probe, the sensed data may be communicated to a processing system (e.g., via a wired or wireless connection) that displays a visual representation of the data on a display screen. Thus, the practitioner can view the display screen while inserting needle 12 to visualize the anatomical structures at which needle 12 is directed and appropriately guide needle 12 towards a target anatomical structure. Advantageously, the practitioner or the practitioner’s assistant does not need to hold and position tool 30 during the procedure. This frees up at least one hand to perform other tasks.

[61] In the embodiment illustrated in FIG. 7A, device 100 comprises a tool holder 700 that is configured to hold a tool 30 at its distal end. Tool holder 700 may be generally U- shaped, with two arms and a holding portion (e.g., formed from curving or bending) connecting the arms, and configured to hold a tool 30 within the holding portion. Alternatively, tool holder 700 may comprise a single arm connected to a holding portion. In either case, the holding portion of tool holder 700 may hold tool 30 via fasteners (e.g., screws, bolts, clips, etc.), friction, clamp, gravity, molding, or any other means for holding a tool 30 in place. For example, the holding portion of tool holder 700 may partially or fully surround tool 30 with an inner diameter that is the same as or slightly smaller than the outer diameter of tool 30, to thereby hold tool 30 in place via friction. U.S. Design Patent No. D391,838, which is hereby incorporated herein by reference as if set forth in full, provides one example of a holding portion for an ultrasound probe. Tool holder 700 may be configured to hold any tool 30 of a single size and/or shape, a single type of tool 30 of different sizes and/or shapes, different types of tools 30 of a single size and/or shape, and/or different types of tools 30 of different sizes and/or shapes.

[62] Tool holder 700 may also comprise a fastener 710 (e.g., screw, bolt, pin, rivet, etc.) at a proximal end of each arm (whether the embodiment has a single arm or two arms) extending from the holding portion. Each fastener 710 may rotationally connect to a side of lower component 120. It should be understood that the fastener 710 on each arm of tool holder 700 may be connected to points on opposing sides of lower component 120. This enables tool holder 700 to rotationally pivot around lower component 120 (and upper component 130, which is coupled to lower component 120). Alternatively, a different pivoting or otherwise movable fastener 710 may be used that enables rotational or other relative movement between tool holder 700 and lower component 120, or a fixed fastener 710 may be used that prevents relative movement between tool holder 700 and lower component 120. In an alternative embodiment, tool holder 700 may be coupled to upper component 130 or coupling mechanism 110, instead of lower component 120. In this case, the fastener between tool holder 700 and upper component 130 or coupling mechanism 110 may be the same as described with respect to fastener 710.

[63] In the embodiment illustrated in FIG. 7B, each arm of tool holder 700 comprises a channel 720 within which fasteners 710 are inserted and slide. Thus, instead of rotating around lower component 120, tool holder 700 slides with respect to lower component 120 to increase or decrease the distance between lower component 120 and the holding portion of tool holder 700, and therefore, tool 30. In this case, at least one fastener 710 may comprise a wing screw that fits through channel 720 and affixes to a corresponding threaded hole in lower component 120. The wing screw can be loosened to enable tool holder 700 to slide with respect to lower component 120 (e.g., channel 720 slides around the wing screw), and tightened to fix the position of tool holder 700 with respect to lower component 120 (e.g., by the force of the wing screw pressing the side surface of tool holder 700 against the side surface of lower component 120). Tool holder 700 may also comprise a distance scale 730 (e.g., printed or molded on the side of tool holder 700) comprising a plurality of markings that each indicate a distance along channel 720, which may, for example, correspond to the distance A between tool 30 and the injection site implied by the trajectory of the tip of needle 12 or the distance B between tool 30 and the target site 42 of an anatomical structure 40 (i.e., a depth of target site 42). Thus, a practitioner may slide fastener 710 within channel 720 or slide channel 720 around fastener 710, until fastener 710 is positioned at the appropriate marking on distance scale 730 for the desired distance.

[64] In addition, in the embodiment illustrated in FIG. 7B, an alternative coupling mechanism 110 is used, which enables the angle X of platform 132 to be adjusted within a fixed range of angles. This embodiment replaces the ball-and-socket mechanism described elsewhere herein. In this embodiment, coupling mechanism 110 is fixed to lower component 120 and comprises at least one arm that extends from lower component 120 to a side of platform 132. It should be understood that two arms could be used for increased stability, in which case the arms would extend to opposing sides of platform 132. Each arm is movably fastened to platform 132 via a fastener 116 that is inserted, through a channel 118 in coupling mechanism 110, into the side of platform 132. Fastener 116 slides within channel 118 within each arm, or channel 118 slides around fastener 116. At least one fastener 116 may comprise a wing screw that can be loosened to enable platform 132 to rotate with respect to coupling mechanism 110, and tightened to fix the angle of platform 132 with respect to coupling mechanism 110. Specifically, the wing screw can be loosened to enable platform 132 to rotate with respect to lower component 120 (e.g., channel 118 slides around the wing screw), and tightened to fix the position of platform 132 with respect to lower component 120 (e.g., by the force of the wing screw pressing the side surface of coupling mechanism 110 against the side surface of platform 132). Notably, channels 118 may be curved, such that each point in each channel 118 is at a fixed radius from the end of platform 132. However, this is not necessary, and points in channels 118 may be at different radiuses from the end of platform 132. In any case, as channel 118 of coupling mechanism 110 slides around fastener 116, the angle X of platform 132, and therefore, the angle of instrument 10, including needle 12, changes. Thus, a practitioner can slide channel 118 around fastener 116 to adjust platform 132 to any angle X, within a range of angles, for percutaneous puncture. Coupling mechanism 110 may comprise an angle scale (e.g., printed on the side of coupling mechanism 110), similar to distance scale 730, comprising a plurality of markings that each indicate the angle X of platform 132 when fastener 116 is aligned with that marking. In an alternative embodiment, the component comprising fastener 116 and channel 118 for angular adjustment of platform 132 may be separate and distinct from coupling mechanism 110.

[65] As illustrated in FIG. 7B, the distance A between the percutaneous insertion site of needle 12 and the center of the bottom of tool 30, the distance B between the bottom of tool 30 and the target site 42 of an anatomical structure 40 (i.e., the depth of target site 42), and the distance C between the insertion site of needle 12 and target site 42 are related by the Pythagorean theorem: A²+B²=C². In addition, the angle X of insertion can be derived as tan ¹(B/A)=X. As discussed above, tool holder 700 may comprise a distance scale 730, representing distance A (or depth B), and coupling mechanism 110 may comprise an angle scale, representing angle X. Thus, a practitioner can move tool holder 700 relative to lower component 120 to select a precise distance A, and rotate platform 132 relative to coupling mechanism 110 to select a precise angle X. This enables the practitioner to precisely position needle 12, such that it will reach target site 42 at depth B directly below tool 30, after being inserted a distance C into the patient’s skin 20. It should be understood that the practitioner may determine the appropriate angle X and distances A, B, and/or C using any of the disclosed or other trigonometric principles, theories, or derivations, including sine or cosine functions.

[66] In an embodiment, device 100 may enable lateral adjustment of platform 132 and/or instrument 10 within platform 132, in addition to or instead of any of the other adjustments described herein. For example, coupling mechanism 110 may enable lateral movement of platform 132 from side to side (i.e., horizontal and orthogonal to the longitudinal axis of platform 132), relative to lower component 120. Alternatively or additionally, platform 132 may enable lateral movement of instrument 10 from side to side. This lateral movement may be provided in addition to a mechanism for rotating platform 132 to adjust the angle of instrument 10.

[67] FIG. 7C illustrates an embodiment of device 100 in which angle X is fixed. In particular, coupling mechanism 110 permanently fixes the relative angle of platform 132 and lower component 120. Angle X may be fixed at a 45-degree angle or any other angle. In this embodiment, since angle X is fixed, the practitioner only needs to adjust fastener 710 to correspond to distance A or depth B. It should be understood that adjustment of fastener 710 actually adjusts distance A, but can be performed in terms of either distance A or depth B (e.g., indicated on distance scale 730), since A and B are related by tan^_1(B/A)=X, where X is fixed.

[68] In addition, in the embodiment illustrated in FIG. 7C, platform 132 is a sled that slides longitudinally along a track 131. The incorporation of this sled feature enables the practitioner to accurately and precisely insert needle 12 into anatomical structure 40 at varying distances C and at angle X. Alternatively, a different mechanism may be used to enable platform 132 to move along its longitudinal axis, relative to the other components of device 100

[69] A securing mechanism 136 (e.g., clamp, screw such as a wing screw, strap, etc.) may be provided through the side of platform 132 to secure instrument 10 to platform 132. Thus, needle 12 and the instrument body (e.g., catheter) of instrument 10 are fixed relative to platform 132 and move smoothly as a single unit with platform 132, as platform 132 is slid along track 131. This maintains instrument 10 at angle X and increases the accuracy of the procedure by limiting the distance which needle 12 can travel.

[70] In an embodiment, an adjustable stop 138 may be attached or integrated into upper component 130 to prevent platform 132 from sliding along track 131 beyond a certain position or distance set by the practitioner. Thus, a practitioner may adjust stop 138 to a position corresponding to the desired distance C, to thereby prevent the tip of needle 12 from proceeding beyond target site 42. Thus, stop 138 can be used to control or limit the maximum depth to which needle 12 can be inserted for precise targeting of target site 42. It should be understood that stop 138 may be implemented in any manner that restricts longitudinal movement of platform 132 and instrument 10, relative to other components of device 100. [71] FIG. 7D illustrates an embodiment of device 100 in which platform 132 comprises a channel 137 that restricts the distance which instrument 10 can travel along the longitudinal axis of platform 132 to a fixed range. In particular, a portion (e.g., protrusion) of instrument 10 may be inserted into channel 137, or a fastener (e.g., wing screw) may be inserted through channel 137 and fixed to instrument 10, such that it slides longitudinally within channel 137 with instrument 10. In addition, platform 132 may comprise a stop 138 that prevents the body of instrument 10 from traveling beyond a certain point (e.g., beyond the distal end of platform 132). Thus, stop 138 may limit the percutaneous travel depth of needle 10 to distance C, thereby increasing accuracy and precision of the percutaneous intervention. It should be understood that distance C may be determined, for example, by the Pythagorean theorem, from distances A and B. In an alternative embodiment, the distance which instrument 10 can travel along the longitudinal axis of platform 132 may be limited (e.g., to a fixed range) by an elastic, magnetic, or other mechanism that utilizes friction.

[72] FIG. 7E illustrates an embodiment of device 100 in which tool holder 700 is integral to coupling mechanism 110 and directly attached to upper component 130, and in which lower component 120 is rotatable with respect to upper component 130 and tool holder 700. In this embodiment, tool holder 700 is similar to tool holder 700 in other embodiments, but is structurally integrated with coupling mechanism 110 in the embodiment illustrated in FIG. 7B. For example, tool holder 700 comprises a fastener 710 that slides in a channel 720 to enable adjustment of the distance between tool 30 and platform 132. In addition, coupling mechanism 110, integral with tool holder 700, comprises a fastener 116 that slides in a channel 118 to enable adjustment of angle X. A distance scale 730 and angle scale may also be provided along channels 720 and 118, respectively.

[73] In the embodiment illustrated in FIG. 7E, the portion of lower portion 120 comprising finger holes 122 may rotate with respect to upper component 130 and tool holder 700. For example, lower component 120 may comprise an attachment component 126 that is attached to or integral with coupling mechanism 110, and a rotating component 128 that is attached to or integral with the portion of lower component 120 comprising finger holes 122. Rotating component 128 is rotatably attached to attachment component 128, such that rotating component 128 can rotate partially (e.g., 90 degrees, 180 degrees, 270 degrees, etc.) or fully (i.e., 360 degrees) around an axis that extends vertically between lower component 120 and upper component 130. Thus, a practitioner may rotate lower component 120 with respect to upper component 130 and tool holder 700. In other words, platform 132 can rotate around a first axis that extends laterally through coupling mechanism 110, and the portion of lower component 120 comprising finger holes 122 can rotate around a second axis that is perpendicular to the first axis and extends vertically through lower component 120. It should be understood that these two degrees of rotation are independent from each other. Thus, platform 132 may be rotated around the first axis without rotating lower component 120 around the second axis, and lower component 120 may be rotated around the second axis without rotating platform 132 around the first axis.

[74] In practice, a practitioner may insert the fingers of a first hand (e.g., the non dominant hand) into finger hole(s) 122, and rotate platform 132 around the vertical axis with his or her second hand (e.g., the dominant hand), such that platform 132 is substantially perpendicular to the fingers of the first hand. The practitioner’ s second hand may then be used to manipulate instrument 10 and/or other features of device 100 during a procedure that includes percutaneous puncture (e.g., to drive needle 12 to target site 42).

[75] Notably, in the embodiment illustrated in FIG. 7E, the pair of finger holes 122 are not completely parallel to each other. Rather, the pair of finger holes 122 separate from each other by a certain degree from parallel. This enables the practitioner to spread the inserted fingers apart by the certain degree. However, in an alternative embodiment, the pair of finger holes 122 may be parallel.

[76] Each of the alternative embodiments have been described herein as possessing certain features. However, any of the features described with respect to one embodiment can be integrated into any of the other embodiments, and vice versa. Thus, it should be understood that the fact that an embodiment of device 100 is described with a certain combination of features does not imply that the described embodiment of device 100 must have those features, or that the described embodiment cannot possess additional or alternative features described herein.

[77] 4. Example Usage

[78] In a preferred embodiment, device 100 enables platform 132 - and therefore, an instrument 10 supported on platform 132 - to be moved, relative to lower component 120, through multiple degrees of freedom and angles to facilitate a percutaneous puncture procedure, while also supporting a tool 30, such as an ultrasound probe or other probe for sensing and visualizing anatomical structures under the skin, in tool holder 700. The practitioner manually moves platform 132, within his or her discretion, to set it to a desired angle for a procedure (e.g., an arterial blood draw) relative to the patient’s skin 20. The practitioner may do this before or after positioning instrument 10 on platform 132 (e.g., placing or sliding instrument 10 onto platform 132, attaching instrument 10 to platform 132 using attachment mechanism 600, securing mechanism 136, etc.). In some cases, the practitioner may utilize the described angle scale or a protractor or other device to precisely set the appropriate angle, prior to use. Alternatively, the angle may be fixed.

[79] Before or after setting the relative angle of platform 132, the practitioner may insert his or her fingers into respective finger holes 122. For example, in a preferred embodiment, device 100 may comprise a finger hole 122A for a middle finger and a finger hole 122B for an index finger. Thus, the practitioner may insert his or her middle finger into finger hole 122A and index finger in finger hole 122B. In embodiments which comprise annular grips 124, annular grips 124 snugly hold the practitioner’s fingers within finger holes 122.

[80] With his or her fingers through finger holes 122, thereby stably holding device 100, the practitioner may take the patient’s pulse using those same fingers. For example, using the portions (e.g., distal phalanx and/or middle phalanx) of the practitioner’s middle and index fingers extending out of the distal end of finger holes 122, under platform 132 (e.g., within the space defined by distance G in FIG. 5), the practitioner may apply pressure to the patient’s artery so as to identify the patient’s pulse. The practitioner may pivot finger guard 134 to an angle that allows the tips of his or her middle and index fingers, extending from finger holes 122, to be placed as close as possible to the desired insertion site for needle 12. However, it should be understood that the practitioner may pivot finger guard 134 to any angle that he or she desires, and may place his or her fingers at any desired distance from the insertion site for needle 12. In any case, finger guard 134 reduces or eliminates the risk of a needlestick injury to the practitioner’s fingers by preventing contact between the fingers and needle 12.

[81] The placement of the practitioner’s fingers and/or lower component 120 on the patient’s skin 20 serves to stabilize platform 132 supporting instrument 10. Thus, the practitioner may stably place device 100 using one hand (e.g., left hand), such that needle 12 of instrument 10 is at the desired angle and on a linear path towards the desired insertion site for reaching a target site 42. In an embodiment, in which lower component 120 is rotatable with respect to upper component 130 and tool holder 700, the practitioner may use his or her other hand (e.g., right hand) to rotate upper component to place the tip of needle 12 near the insertion site.

[82] In an embodiment, the practitioner may also precisely adjust the angle, distance, and/or depth of device 100. For example, the practitioner may move fastener 116 within channel 118 to set a precise angle X and/or move fastener 710 within channel 720 to set a precise distance A (or depth B). Once all adjustments have been made, such that needle 12 has been properly positioned along a planned trajectory to target site 42, the practitioner may use his or her other hand (e.g., right hand) to slide instrument 10 on a downward linear trajectory along the longitudinal axis of platform 132 to thereby push needle 12 through the patient’s skin 20 at the desired insertion site and towards target site 42. In some embodiments disclosed herein, instrument 10 is restricted to only move along the linear trajectory, thereby reducing or eliminating inadvertent lateral movement of needle 12, and/or restricted to only move a certain distance along the linear trajectory.

[83] During the percutaneous procedure, the practitioner may view a display screen that displays a visual representation of anatomical structures under the patient’s skin 20, as sensed by tool 30. For example, if tool 30 is an ultrasound probe, the ultrasound probe may collect ultrasound data from the area around target site 42 along the trajectory of needle 12, and transmit that ultrasound data, wirelessly or via a wired connection, for display as visual data on the display screen. It should be understood that the ultrasound data may be processed into visual data by the ultrasound probe itself, or may be sent by the ultrasound probe to a processing device (e.g., ultrasound machine or a general-purpose computer) that processes the ultrasound data into visual data prior to display on the display screen.

[84] Compared to prior methods of percutaneous puncture, use of device 100 decreases the overall time for the procedure. Since such procedures are often performed during emergency situations, the decrease in time can improve overall patient outcomes. In fact, the improved time can be the difference between a patient living or dying. Furthermore, in procedures requiring anesthesia, the decrease in time may advantageously decrease the amount of time that a patient must remain anesthetized.

[85] In addition, use of device 100 has the potential to enable less experienced practitioners or even trainees to perform some procedures. Specifically, by increasing accuracy, device 100 can decrease pain and the risk of infection for patients, since fewer punctures translates to fewer infection-prone breaks in the patients’ skin 20. Thus, during an operation or emergency, a less skilled healthcare practitioner could perform the procedure, while the more experienced healthcare practitioner is freed to use his or her time and expertise to address other issues.

[86] Advantageously, device 100 enables a practitioner to palpate the radial artery pulse, distal to the needle insertion site during insertion of needle 12, thereby eliminating the problem of decreased blood flow to the needle insertion site. Due to the presence of protective finger guard 134 below platform 132 of device 100, in some embodiments, the practitioner can insert needle 12 closer to the site of palpation without having to worry about a needlestick injury to the practitioner’s fingers. The closer that needle 12 is to the identified pulsation, the greater the chance of successfully puncturing the artery.

[87] Any patient admitted to a hospital or undergoing surgery may benefit from device 100. For example, for surgical patients, the decreased time needed for the procedure decreases the time spent under general anesthesia. Patients under general anesthesia must be intubated. Since intubation raises the risk of numerous complications, decreasing the time a patient spends under general anesthesia - and thus, intubated - can decrease overall morbidity and mortality associated with surgery. For non-surgical patients, quicker, more efficient, and more accurate percutaneous procedures can decrease both the pain that the patients experience and the patients’ risk of injury from exposure to the procedure.

[88] The above description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles described herein can be applied to other embodiments without departing from the spirit or scope of the invention. Thus, it is to be understood that the description and drawings presented herein represent a presently preferred embodiment of the invention and are therefore representative of the subject matter which is broadly contemplated by the present invention. It is further understood that the scope of the present invention fully encompasses other embodiments that may become obvious to those skilled in the art and that the scope of the present invention is accordingly not limited.

[89] Combinations, described herein, such as “at least one of A, B, or C,” “one or more of A, B, or C,” “at least one of A, B, and C,” “one or more of A, B, and C,” and “A, B, C, or any combination thereof’ include any combination of A, B, and/or C, and may include multiples of A, multiples of B, or multiples of C. Specifically, combinations such as “at least one of A, B, or C,” “one or more of A, B, or C,” “at least one of A, B, and C,” “one or more of

A, B, and C,” and “A, B, C, or any combination thereof’ may be A only, B only, C only, A and

B, A and C, B and C, or A and B and C, and any such combination may contain one or more members of its constituents A, B, and/or C. For example, a combination of A and B may comprise one A and multiple B’s, multiple A’s and one B, or multiple A’s and multiple B’s.

Claims

CLAIMS What is claimed is:

1. A device to assist in percutaneous punctures, the device comprising: an upper component comprising a platform configured to support a medical instrument comprising a needle; a lower component comprising one or more finger holes, wherein each of the one or more finger holes is configured to receive a human finger therethrough; a coupling mechanism that couples the lower component to the upper component; and a tool holder configured to hold a tool at a position that, when the platform is supporting the medical instrument, is on an opposite side of a tip of the needle as the lower component.

2. The device of Claim 1, wherein a cross section of the platform, in a plane that is perpendicular to a longitudinal axis of the platform, is semi-circular.

3. The device of Claim 1, wherein the lower component comprises at least two finger holes.

4. The device of Claim 3, wherein the lower component consists of two finger holes.

5. The device of Claim 1, wherein the tool comprises an ultrasound probe.

6. The device of Claim 1, wherein the tool holder comprises at least one arm and a holding portion at a distal end of the at least one arm, wherein the at least one arm is fastened to a side of lower component.

7. The device of Claim 6, wherein the at least one arm is fastened to the lower component by a fastener that is configured to pivot, such that the tool holder is rotatable with respect to the lower component.

8. The device of Claim 6, wherein the at least one arm comprises a channel, and wherein the at least one arm is fastened to the lower component by a fastener that is inserted through the channel and is configured to slide within the channel, such that a distance between the lower portion and the holding portion of the tool holder is adjustable.

9. The device of Claim 8, wherein a side surface of the at least one arm comprises a distance scale comprising a first plurality of markings that indicate a distance represented by each of a plurality of positions along the channel.

10. The device of Claim 9, wherein the coupling mechanism comprises at least one arm comprising a channel, and wherein the at least one arm is fastened to the upper component by a fastener that is inserted through the channel and is configured to slide within the channel.

11. The device of Claim 10, wherein the channel is curved, such that an angle between the lower component and the upper component is adjustable.

12. The device of Claim 11, wherein a side surface of the at least one arm comprises an angle scale comprising a second plurality of markings that indicate an angle represented by each of a plurality of positions along the channel.

13. The device of Claim 12, wherein each of the first plurality of markings indicate a value A within a range of distances, wherein each value of A within the range of distances represents a different distance from an injection site, along a trajectory of the needle when the medical instrument is supported on the platform, to a center of the bottom of the tool when the tool is held in the tool holder, wherein each of the second plurality of markings indicate a value X within a range of angles of the platform relative to the lower component, and wherein the first and second pluralities of markings are positioned such that tan ¹(B/A)=X is satisfied for every value of A indicated by the first plurality of markings and every value of X indicated by the second plurality of markings, and wherein B is a depth under the center of the bottom of the tool, when the tool is held in the tool holder, that satisfies A²+B²=C², wherein C is a length of a hypotenuse of a right triangle formed by A, B, and C.

14. The device of Claim 1, wherein the upper component is fixed, by the coupling mechanism, at an angle relative to the lower component.

15. The device of Claim 1, wherein the upper component comprises a track, and wherein the platform is configured to slide longitudinally along the track.

16. The device of Claim 15, wherein the platform comprises a securing mechanism that is configured to secure the medical instrument to the platform.

17. The device of Claim 15, wherein the upper component comprises an adjustable stop that is configured to restrict the platform from sliding longitudinally along the track beyond a set position.

18. The device of Claim 1, wherein the platform comprises: a channel within which the medical instrument slides; and a stop that prevents a body of the medical instrument from sliding beyond a position at a distal end of the platform.

19. The device of Claim 1, wherein the tool holder is integral with the coupling mechanism, wherein the integral tool holder and coupling mechanism comprises at least one arm comprising a channel, wherein the at least one arm is fastened to the upper component by a fastener that is inserted through the channel and is configured to slide within the channel, and wherein the channel is curved, such that an angle between the lower component and the upper component is adjustable.

20. The device of Claim 19, wherein the lower component is configured to rotate, relative to the tool holder and the upper component, around an axis extending between the lower component and the upper component.