NEEDLE BENDING DEVICE

Abstract

Provided herein are devices, systems, and methods for bending a needle. More particularly, the present disclosure provides materials and methods relating to bending the 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.

Claims

1. A needle bending device comprising: a base; a hollow slider conduit; and a bending element.

2. The device of claim 1, wherein the base comprises a needle hub housing at a proximal end of a shaft.

3. The device of claim 2, wherein the needle hub housing is configured to receive a needle and engage a needle hub.

4. The device of claim 2 or claim 3, wherein the shaft comprises an elongated internal chamber configured to receive the hollow slider conduit from a distal end.

5. The device of claim 4, wherein 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.

6. The device of any of claims 1-5, wherein the hollow slider conduit has an open distal end.

7. The device of any of claims 1-5, wherein the hollow slider conduit has a closed distal end comprising an aperture.

8. The device of any of claims 1-7, wherein 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.

9. The device of any of claims 1-8, wherein the hollow slider conduit comprises a notch on the exterior surface proximal to the bending element.

10. The device of claim 9, wherein the hollow slider conduit comprises a hinged flap configured to be received in the notch.

11. The device of claim 10, further comprising a press.

12. The device of any of claims 1-11, wherein the hollow slider conduit comprises a fulcrum.

13. The device of any of claims 1-12, wherein the bending element engages with the hollow slider conduit at a distal end.

14. The device of any of claims 1-13, wherein the bending element is fully or partially transparent or semi-transparent.

15. The device of any of claims 1-14, wherein the bending element comprises an opening.

16. The device of any of claims 1-14, wherein the bending element comprises an indication of bend angle.

17. The device of claim 16, wherein the indication corresponds to a bend angle of less than or equal to 30 degrees.

18. The device of claim 16 or 17, wherein the indication corresponds to a bend angle of about 5 degrees.

19. The device of any of claims 1-18, further comprising a clamp attached to the slider conduit.

20. The device of claim 19, wherein the clamp comprises a clamping element that engages the needle and holds the needle in a substantially secure position.

21. The device of claim 19 or 20, wherein the clamp comprises a latching mechanism that allows the clamp to engage the slider conduit and hold the clamp in a substantially secure position.

22. The device of any of claims 19-21, wherein the clamp is detachably coupled to the slider conduit.

23. The device of any of claims 1-22, wherein the slider conduit comprises a flange that prevents unintentional release of the slider conduit from the shaft.

24. The device of any of claims 1-23, further comprising a needle.

25. The device of claim 24, wherein the needle comprises a gauge ranging from about 20 to about 26.

26. The device of claim 24 or 25, wherein the needle is 2 to 6 inches long.

27. The device of any of claims 24-26, wherein the needle is a spinal needle.

28. A kit comprising: the device of any of claims 1-23; a needle; and a container.

29. The kit of claim 28, wherein the needle comprises a gauge ranging from about 20 to about 26.

30. The kit of claim 28 or 29, wherein the needle is 2 to 6 inches long.

31. The kit of any of claims 28-30, wherein the needle is a spinal needle.

32. The kit of any of claims 28-31, further comprising a syringe.

33. A method comprising bending a needle using the device of any of claims 1 to 27.

34. The method of claim 33, wherein the bending comprises actuating the needle bending element to a desired needle bend angle.

35. The method of claim 34, wherein the desired needle bend angle is less than or equal to 30 degrees.

36. The method of any of claims 33-35, further comprising: 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.

37. The method of any of claims 33-36, further comprising: positioning a clamp on the exterior surface of the slider conduit proximal to the bending element.

38. The method of any of claims 33-37, further comprising: inserting the needle into the base; and securing a needle hub in the needle hub housing.

39. The method of any of claims 33-38, further comprising: positioning the clamp such that it engages and secures the needle; and applying pressure to the bending element to create a bend in the distal end of the needle.

40. The method of any of claims 33-39, further comprising: disengaging needle from the needle bending element, the hollow slider conduit, and the base, simultaneously or sequentially.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] FIGS. 1A-1C show alternative views of an exemplary needle bending device comprising a base, a slider conduit, and a bending element comprising a needle, according to one embodiment of the present disclosure.

[0033] FIGS. 2A-2B show alternative views of an exemplary needle bending device comprising a base, a slider conduit, and a bending element mounted on a needle, according to one embodiment of the present disclosure.

[0034] FIGS. 3A-3B show alternative views of an exemplary needle bending device comprising a base, a slider conduit, and a bending element mounted on a needle, according to one embodiment of the present disclosure.

[0035] FIG. 4 shows an exemplary base of a needle bending device, according to one embodiment of the present disclosure.

[0036] FIG. 5 shows an exemplary slider conduit of a needle bending device, according to one embodiment of the present disclosure.

[0037] FIG. 6 shows an exemplary bending element of a needle bending device, according to one embodiment of the present disclosure.

[0038] FIG. 7 shows engagement of an exemplary bending element and slider conduit during or after a needle bending process, according to one embodiment of the present disclosure.

[0039] FIG. 8 shows an exemplary needle bent using a device as disclosed, according to one embodiment of the present disclosure.

[0040] FIGS. 9A and 9B are representative images of exemplary slider conduits with corresponding bending elements, according to one embodiment of the present disclosure. FIG. 9A is an exemplary slider conduit comprising a slot running lengthwise along the conduit between the outer surface of the slider conduit and the internal chamber. In FIG. 9B the slider conduit comprises a notch in the outer surface. The notch may be configured to receive a press or a hinged flap connected to the slider conduit.

[0041] FIGS. 10A-10D show an exemplary needle bending device that includes a clamp that secures the distal portion of a needle in the device for subsequent bending, according to one embodiment of the present disclosure. FIGS. 10A and 10B provide perspective views of the distal end of the device, including the clamp and bending element. FIGS. 10C and 10D provide side views of the clamp in an engaged (FIG. 10C) or disengaged (FIG. 10D) position, which obviates the need for finger pressure.

[0042] FIGS. 11A-11B show exemplary results of strain tests using the needle bending device of the present disclosure. FIG. 11A shows that a force of 0.01 N applied to the needle tip causes a deformation of 2.37 mm, while FIG. 11B shows that a force of 6,400,000 N/m of stress occurs at the base of the slider when the strain is set at 2.3 mm.

[0043] FIGS. 12A-12B show an exemplary needle bending device that includes a clamp that secures the distal portion of a needle in the device for subsequent bending, according to one embodiment of the present disclosure. FIG. 12A provides a perspective side view of the distal end of the device that includes the clamp in a partially disengaged position, while FIG. 12B provides a perspective side view of the clamp in an engaged position.

[0044] FIGS. 13A-13B show an exemplary needle bending device that includes a flange at the proximal end of the slider conduit that prevents it from fully exiting the distal end of the shaft, according to one embodiment of the present disclosure. FIG. 13A provides a side view of the flange prior to full engagement with the distal end of the shaft (double arrows), while FIG. 13B provides a side view of the flange fully engaged against the distal end of the shaft.

DETAILED DESCRIPTION

[0045] Illustrative embodiments of the invention are shown in the figures. It should be understood that the invention is not limited to these particular examples.

[0046] 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.

[0047] 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).

[0048] An exemplary device is shown in FIGS. 1A-1C. The needle bending device 100 comprises base 110, hollow slider conduit 120, and bending element 130. The device may, in some instances, further comprise a needle 210 having needle hub 200. Base 110 comprises needle hub housing 150 on a proximal end of shaft 140. Needle hub housing 150 is configured to receive needle 210 and engage with needle hub 200. The alignment of needle hub 200 in needle hub housing 150 is indicative of needle tip bevel angle and, as such, controls the orientation of the needle bend to the bevel (e.g., with or away from bevel).

[0049] Base shaft 140 comprises an elongated internal chamber 300 (FIG. 4) adapted to receive hollow slider conduit 120 from the distal end and allow passage of needle 210. The internal chambers of both the base shaft 140 and slider conduit 120 are of wide enough diameter to allow passage of a needle following bending, such that the bend will not be removed upon disengaging the needle from the device 100. The external and internal dimensions of base shaft 140 and slider conduit 120 are selected to house a number of different gauges of needles and for usability and convenience.

[0050] In some embodiments, the interior surface of elongated chamber 300 comprises at least one groove 310 (FIG. 4) to receive one or more ridges 320 (FIG. 5) on the outer surface of slider conduit 120. Slider conduit 120 may move longitudinally within the elongated chamber of the base shaft 140 along grooves 310 to accommodate needles of any length and allow customizable positioning of the bend. The device can be used with any needle length ranging from 2 to 6 inches. For example, a spinal needle is commonly 3.5 inches in length.

[0051] Aperture 160 (FIG. 5) at the distal end of slider conduit 120 allows needle tip 220 to extend beyond the end of slider conduit 120 and into bending element 130, as shown in FIG. 3A and FIG. 7. The distal end of slider conduit 120 engages with bending element 130 such that actuating bending element 130 in a lateral arc movement results in bending of needle 210 at fulcrum 170. Thus, the user can easily bend needle 210 to a desired configuration or angle by applying pressure to bending element 130 which in turn applies pressure to the portion of the needle remaining outside slider conduit 120 at fulcrum 170. By conforming needle 210 to fulcrum 170, the user can bend needle 210 to a desired angle. Throughout the bending process, needle tip 220 is confined within the walls of the bending element 130 and the remaining portion of the shaft of needle 210 is protected and stabilized within the internal chambers of base shaft 140 and slider conduit 120.

[0052] 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.

[0053] FIGS. 2A-2B and FIGS. 3A-3B show alternative views of exemplary embodiments of the devices of the present disclosure with differing needle hub housings 150. Needle hub housing 150 may be configured to receive different needle hub 200 designs as used by different commercial suppliers of needles.

[0054] FIG. 4 shows an exemplary embodiment of a base 110 comprising a needle hub housing 150 on a proximal end of shaft 140. In this embodiment, base shaft 140 has an elongated internal chamber 300, the interior surface of which comprises a plurality of grooves 310 to orientate and support the slider conduit 120. The internal dimension of the base shaft 140 is designed to encompass the slider conduit 120 and allow needles of a variety of gauges to be disengaged following bending in such a manner to retain the bend.

[0055] FIG. 5 shows an exemplary embodiment of slider conduit 120. In this embodiment, the outer surface of slider conduit 120 comprises a plurality of ridges 320 to engage with base shaft 140. The internal dimension of slider conduit 120 is designed to allow needles of a variety of gauges to be disengaged following bending in such a manner to retain the bend. The distal end of slider conduit 120 comprises fulcrum 170 and aperture 160. The location of the bend is dictated by the location of fulcrum 170 along the shaft of needle 210. Aperture 160 is an opening in a capped distal end of the slider conduit 120 which allows the needle tip to exit slider conduit 120 and enter bending element 130. In this embodiment, aperture 160 extends halfway across the capped end of slider conduit 120. However, the aperture may be of any size or shape which allows needle 210 to enter and exit slider conduit 120 and bending element 130 before and after being bent. Alternatively, the distal end of slider conduit 120 may be open.

[0056] 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 FIG. 9B. The notch may receive a fingertip, or a press. A press may be a small piece of material (e.g., plastic, metal, or the like) with at least one flat surface able to be accommodated by the size of the notch. As such, the device may further comprise a press. Alternatively, slider conduit 120 may further comprise a hinged flap which covers notch. The fingertip, press, and hinged flap support the needle during bending.

[0057] FIG. 6 shows one embodiment of bending element 130. Bending element 130 may be semi-transparent, transparent, or have a viewing window to facilitate visualization of needle tip 220 during bending. Bending element 130 may have markers, gradations, or other similar indications of the degree of bend to allow the user to select desired angles. The device facilitates bends of less than or equal to 30 degrees (e.g., about 20 degrees, about 15 degrees, about 10 degrees, about 5 degrees). Alternatively, bending element 130 may be configured to bend the needle tip to a preset angle, for example 5 degrees.

[0058] FIG. 7 shows a cross-sectional view of one embodiment of bending element 130 engaged with slider conduit 120 during the process of bending needle 210. As described above, the combination of the bending element 130 and slider conduit 120 allows the user to bend needle 210 to a desired configuration or angle by applying pressure to the bending element 130 which in turn applies pressure to the portion of the needle remaining outside the slider conduit 120 to bend the needle along the shaft at 170. The user can bend the needle to a desired angle as determined by the markers, gradations, or other similar indications on the bending element 130. Needle tip 220 is protected within the bending element 130.

[0059] FIG. 8 shows needle 210 following disengagement with the device (not shown). Needle 210 comprises bend 230 on the distal end of the shaft but proximal to needle tip 220. The needle can be attached to a syringe or other device at needle hub 200.

[0060] 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.

[0061] 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)).

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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 FIGS. 10A-10D, clamp 135 is functionally coupled to slider conduit 120 such that it can pivot up and down, or slide forward and backward along slider conduit 120 to engage the needle (FIGS. 12A-12B). Clamp 135 includes a latch or latching mechanism 145, which allows clamp 135 to engage a portion of slider conduit 120 and hold the needle in a substantially secure position when it is being bent by a user.

[0066] 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.

[0067] 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 FIGS. 10A-10D, clamp 135 can be attached to the slider conduit 120 using a mechanism that allows for clamp 135 to pivot up (disengaged position) and down (engaged position) relative to slider conduit 120. FIGS. 10A-10D provide an exemplary structure of a clamp 135 that is attached to slider conduit 120 using two pivot screws 175 on either side of clamp 135.

[0068] In other embodiments, such as those shown in FIGS. 12A-12B, clamp 135 and clamping element 155 can be attached to slider conduit 120 using a mechanism that allows clamp 135 to pivot up and down as well as slide forward and backward along the longitudinal axis of slider conduit 120. FIGS. 12A-12B provide an exemplary slot structure 175 that includes a channel on either side of slider conduit 120 into which a peg can be inserted to allow backward (disengaged position) and forward (engaged position) movement relative to slider conduit 120. This mechanism can also include a latch or latching mechanism 145 (see also FIGS. 10A-10D) that allows clamp 135 to engage a complementary portion of slider conduit 120 and hold the needle in a substantially secure position when it is being bent by a user.

[0069] 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.

[0070] As shown in FIGS. 11A-11B, experiments were conducted to measure the stress and shape of a needle as it exits the slider conduit after bending. For example, one set of analyses was performed using a 25 gauge, 3.5″ needle, with an O.D. of 0.5144 mm and I.D. of 0.260 mm. Bending forces were applied by the bending element 130, and the maximum tip length of the needle was 10 mm. For a post-bend deflection angle of about 5°, the tip displacement was 0.73 mm. For a post-bend deflection angle of about 15°, the tip displacement was 2.23 mm. Maximum elongation will occur at the 15° bend. The radius of curvature for the bent portion of the cannula was 12.75 mm. Assuming symmetric compression and elongation for the outer fibers, the elongation at the outside was 2.0%, which is well within the 7% maximum, which demonstrates that the structural integrity of the needle was intact after bending. Similarly, FIGS. 11A-11B show exemplary results of strain tests using the needle bending device of the present disclosure. FIG. 11A shows that a force of 0.01 N applied to the needle tip causes a deformation of 2.37 mm, while FIG. 11B shows that a force of 6,400,000 N/m of stress occurs at the base of the slider when the strain is set at 2.3 mm. This is less than 0.1 of the yield stress, which demonstrates that the needle can be removed from the slider conduit after bending without altering the bend created by the user.

[0071] 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, FIGS. 13A-13B show an exemplary needle bending device that includes a flange 185 at the proximal end of slider conduit 120 that prevents it from fully exiting the distal end of shaft 140. FIG. 13A provides a side view of flange 185 prior to engagement with the distal end of shaft 140 (see double arrow), while FIG. 13B provides a side view of flange 185 fully engaged against the distal end of shaft 140, which prevents it from exiting shaft 140. Slot 175 on the conduit slider 120 is also shown. Other configurations are also possible, as long as slider conduit 120 engages shaft 140 in a manner that prevents an unintentional release (e.g., release during needle bending) of slider conduit 120 from shaft 140.

[0072] 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.

[0073] 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.