Provided herein are devices, systems, and methods for bending a needle. More particularly, the present disclosure provides materials and methods relating to bending a distal end of a needle with more precision than conventional means, which improves the performance of various medical procedures and leads to better patient outcomes.
Fine-gauge needles are commonly used to reduce unwanted side-effects of large gauge needles. For example, with respect to performing a medical procedure, a fine-gauge spinal needle is used to reduce puncture headaches. However, fine-gauge needles can be associated with increased risk of placement failure as a result of deflection that occurs while performing a medical procedure. Needle deflections are primarily attributed to unbalanced force interactions at the tip of the needle during insertion into or through tissue(s). Medical professionals utilize needle bending to offset needle deflection, thereby facilitating better control of needle placement. Since needle bending is commonly done manually by the medical professional just prior to performing a medical procedure, it is often imprecise and not reproducible. Although pre-bent needles are available, they are typically limited to those having bend angles that are mass-produced, which does not allow for a customized bend that takes into account important factors for performing a medical procedure, such as the nature of the procedure or patient characteristics.
Embodiments of the present disclosure include a needle bending device, and related methods of bending a needle for therapeutic purposes. In accordance with these embodiments, the device includes a base, a hollow slider conduit, and a bending element.
In some embodiments, the base comprises a needle hub housing at a proximal end of a shaft.
In some embodiments, the needle hub housing is configured to receive a needle and engage a needle hub.
In some embodiments, the shaft comprises an elongated internal chamber configured to receive the hollow slider conduit from a distal end.
In some embodiments, the elongated internal chamber comprises one or more grooves on an interior surface to receive one or more ridges on an exterior surface of the hollow slider conduit.
In some embodiments, the hollow slider conduit has an open distal end. In some embodiments, the hollow slider conduit has a closed distal end comprising an aperture. In some embodiments, the hollow slider conduit comprises a slot running parallel along the length of the hollow slider conduit and perpendicular from the exterior surface to an internal chamber of slider conduit. In some embodiments, the hollow slider conduit comprises a notch on the exterior surface proximal to the bending element. In some embodiments, the hollow slider conduit comprises a hinged flap configured to be received in the notch.
In some embodiments, the device further comprising a press.
In some embodiments, the hollow slider conduit comprises a fulcrum.
In some embodiments, the bending element engages with the hollow slider conduit at a distal end.
In some embodiments, the bending element is fully or partially transparent or semi-transparent. In some embodiments, the bending element comprises an opening. In some embodiments, the bending element comprises an indication of bend angle. In some embodiments, the indication corresponds to a bend angle of less than or equal to 30 degrees. In some embodiments, the indication corresponds to a bend angle of about 5 degrees.
In some embodiments, the device further comprises a clamp attached to the slider conduit. In some embodiments, the clamp comprises a clamping element that engages the needle and holds the needle in a substantially secure position. In some embodiments, the clamp comprises a latching mechanism that allows the clamp to engage the slider conduit and hold the clamp in a substantially secure position. In some embodiments, the clamp is detachably coupled to the slider conduit.
In some embodiments, the slider conduit comprises a flange that prevents unintentional release of the slider conduit from the shaft.
In some embodiments, the device further comprises a needle. In some embodiments, the needle comprises a gauge ranging from about 20 to about 26. In some embodiments, the needle is 2 to 6 inches long. In some embodiments, the needle is a spinal needle.
Embodiments of the present disclosure also include a kit comprising any of the devices described herein, a needle, and a container.
In some embodiments, the needle comprises a gauge ranging from about 20 to about 26. In some embodiments, the needle is 2 to 6 inches long. In some embodiments, the needle is a spinal needle.
In some embodiments, the kit further comprises a syringe.
Embodiments of the present disclosure also include a method for bending a needle using any of the devices described herein.
In some embodiments, the bending comprises actuating the needle bending element to a desired needle bend angle. In some embodiments, the desired needle bend angle is less than or equal to 30 degrees.
In some embodiments, the method comprises positioning the hollow slider conduit within the base, and positioning the needle bending element over at least a portion of the hollow slider conduit at a distal end.
In some embodiments, the method comprises positioning a clamp on the exterior surface of the slider conduit proximal to the bending element.
In some embodiments, the method comprises inserting the needle into the base, and securing a needle hub in the needle hub housing.
In some embodiments, the method comprises positioning the clamp such that it engages and secures the needle, and comprises applying pressure to the bending element to create a bend in the distal end of the needle.
In some embodiments, the method comprises disengaging needle from the needle bending element, the hollow slider conduit, and the base, simultaneously or sequentially.
To facilitate understanding of the invention, a number of terms are defined below.
“Fulcrum,” as used herein, refers to the point or structure which provides the pivot point for the bend being introduced in the needle.
A “needle” refers to any medically relevant needle which is hollow, having a needle lumen, and usually comprises a bevel on the needle tip. The needle may be a hypodermic needle, a dialysis needle, a huber needle, and a spinal needle.
A needle “gauge” refers to the diameter of a needle. Different gauge systems are known in the art. For purposes of referring to specific dimensions, the numerical gauge values provided herein employ the Birmingham gauge (also known as the Stubs Iron Wire Gauge or Birmingham Wire Gauge). Table 1 below provides internal and external diameter values for some exemplary needle gauges. The device may be used with any gauge of needle, with a preference for finer or higher gauge needles. In some embodiments, the gauge is between 22 and 26.
A “syringe” is a device comprising a barrel, typically but not necessarily tube-shaped, for injecting or withdrawing a sample in a thin stream, typically through a hollow needle. Samples are injected or withdrawn via pressure, typically from a reciprocating pump (e.g., employing a piston or plunger). A plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take in and expel liquid or gas through a discharge orifice at the front (open) end of the tube. Syringes are fitted onto a needle at the needle hub.
Illustrative embodiments of the invention are shown in the figures. It should be understood that the invention is not limited to these particular examples.
Devices of the present disclosure can be used to bend a needle at different, user-selectable locations along the length of the needle and user-selectable angles. For example, the devices of the present disclosure can be used to bend a distal portion of a needle to an angle that is equal to or less than 30 degrees without damaging the needle lumen. The components of the devices may be made of any suitable material, including, but not limited to, metals, metal alloys, plastics, glass, ceramics, polymeric materials, and any combinations thereof. In some cases, the materials are non-allergenic and sterilizable. The devices and methods described herein can find use in any context in which a medical procedure is performed, including research and clinical, e.g., surgical and therapeutic, settings.
Embodiments of the devices, systems, and methods of the present disclosure provide the ability to customize a needle for any therapeutic and/or medical use. For example, thin needles, which are ideally suited to decrease the size of a puncture, do not travel in a straight path when inserted into dense tissue resulting in undesired placement of the needle tip. For example, fine-gauge spinal needles are commonly used to reduce puncture headaches of large gauge needles but have increased risk of deflection while passing through tissue due to the finer gauge. The devices disclosed herein allow customized needle bends, which improve the maneuverability and physician control for quicker and more precise needle placement into the target structure or area thereby decreasing the chance of injury or complication (e.g., bleeding).
An exemplary device is shown in
Base shaft 140 comprises an elongated internal chamber 300 (
In some embodiments, the interior surface of elongated chamber 300 comprises at least one groove 310 (
Aperture 160 (
The location of the bend is dictated by the position of needle 210 about fulcrum 170 and may be varied by moving slider conduit 120 longitudinally within the elongated chamber of the base shaft 140, as described above. Commonly the bend is positioned in the distal half of the needle, within a few centimeters of the tip. For example, in a 3.5 inch spinal needle bends are commonly positioned in the range of the distal 1 cm+/−0.5 cm of the needle.
In alternative exemplary embodiments, slider conduit 120 comprises a slot running parallel along the length of slider conduit 120 and perpendicular from the outer surface to the internal chamber of slider conduit 120. In some embodiments, the slot facilitates facile removal of the needle from the device. Additionally, the distal end of slider conduit 120 may contain notch 180, as shown in
The device may further comprise a needle. The device may be used with any gauge of needle, with a preference for finer or higher gauge needles. In some embodiments, the gauge is between 20 and 26. In certain embodiments, the needle is 22 gauge or 25 gauge. The device can be used with any needle length ranging from 2 to 6 inches. The needle may be between 2 and 6 inches long. In certain embodiments, the needle is 3.5 inches long. In select embodiments, the needle is a spinal needle.
The devices of the present disclosure may be provided separately from a needle, and in some cases, in sterile packaging. The device may be supplied as part of a system and/or kit with or without a needle. The system or kit may further comprise a syringe or other device used for injection or removal of a sample (e.g., autoinjector, vial, tubing (e.g., catheter tubing)).
Individual components of the kits may be physically packaged together or separately, and in some cases, in sterile packaging. The components of the kit may be provided in multi-use or single-use amounts of the components. The kits can also comprise instructions for using the components of the kit. The instructions are relevant materials or methodologies pertaining to the kit. The materials may include any combination of the following: background information, list of components and their availability information (purchase information, etc.), brief or detailed protocols for using the compositions, trouble-shooting, references, technical support, and any other related documents. Instructions can be supplied with the kit or as a separate member component, either as a paper form or an electronic form which may be supplied on computer readable memory device or downloaded from an internet website, or as recorded presentation.
It is understood that the disclosed systems and kits can be employed in connection with the disclosed methods. The systems and kits may further contain containers, devices, or compositions for use with the methods employing the kit or using a bent needle, for example, imaging equipment, dyes or dye composition, and the like.
Also disclosed herein are methods of using the device disclosed herein to bend a needle. The needle may be bent by actuating the needle bending element to a desired angle. The desired angle for the needle bend is less than or equal to 30 degrees (e.g., about 20 degrees, about 15 degrees, about 10 degrees, about 5 degrees). The method may further comprise at least one or all of positioning the hollow slider conduit within the base, positioning the needle bending element over at least a portion of the hollow slider conduit at a distal end, and disengaging needle from the needle bending element, the hollow slider conduit, and the base simultaneously or sequentially. In those embodiments in which the device is supplied without a needle, the method further comprises inserting the needle into the base and securing a needle hub in the needle hub housing.
Embodiments of the present disclosure also include a needle bending device that includes a clamp that engages the needle and obviates the need to apply finger pressure to the needle when in operation. As shown in
Clamp 135 also includes a clamping element 155 that bisects clamp 135 in a longitudinal manner. Clamping element 155 is configured to enter a slot 165 in the top portion of slider conduit 120, such that when clamp 135 is engaged against with the slider conduit 120, clamping element 155 contacts the needle and holds it in a substantially secure position while being bent by a user. The clamping element can be configured in any manner as long as it is able to enter and exit slot 165 and engage/disengage the needle. In some embodiments, the clamping element is generally solid but includes a groove along its center axis to allow for engagement with the needle. In other embodiments, the clamping element is bifurcated such that each of its two bifurcated sides engage the needle. Other configurations are also possible, as long as the clamping element engages the needle in a substantially secure manner. For example, in some embodiments, the surface of the clamping element that engages the needle can include a material that reduces friction and/or dampens vibrations, which can lessen stress on the needle during bending.
In general, as would be appreciated by one of ordinary skill in the art based on the present disclosure, clamp 135 and clamping element 155 can be detachably coupled to the slider conduit 120, or clamp 135 and clamping element 155 can be attached to the slider conduit 120 in a more or less permanent manner. In some embodiments, as shown in
In other embodiments, such as those shown in
In accordance with these embodiments, the clamp and clamping element can be detachably coupled to the slider conduit to allow for a user to exchange one clamp for another. For example, in some cases, it may be advantageous to use different clamps to accommodate needles with different sizes, shapes, and/or gauges. In this manner, a user can exchange one clamp for another and bend needles with different sizes in a single procedure, which can reduce cost and improve efficiencies.
As shown in
Embodiments of the present disclosure also include needle bending devices that comprise a mechanism that secures slider conduit 120 in position during use. For example,
It is understood that the foregoing detailed description and accompanying figures are merely illustrative and are not to be taken as limitations upon the scope of the disclosure, which is defined solely by the appended claims and their equivalents.
Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art and may be made without departing from the spirit and scope thereof.
This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63/081,059 filed Sep. 21, 2020, which is incorporated herein by reference in its entirety for all purposes.
Filing Document | Filing Date | Country | Kind |
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PCT/US21/50381 | 9/15/2021 | WO |
Number | Date | Country | |
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63081059 | Sep 2020 | US |