VERTICAL NEEDLE GUIDE
Related Applications
[0001] This patent application claims priority to U.S. Provisional Patent Application Serial No. 63/685,761, filed August 22, 2024, and U.S. Provisional Patent Application Serial No. 63/599,818, filed November 16, 2023, the full disclosures of which are incorporated herein by reference.
Technical Field
[0002] This document relates generally to an apparatus adapted for placing a needle at a specific location and depth using an ultrasound probe.
Background
[0003] This document relates to a new and improved apparatus specifically adapted to allow one to easily and precisely place a needle at a specific location and a specific depth using an ultrasound probe. In this way it is possible for one to consistently find and place the end or tip of the needle at a desired, target location, such as in a vessel of a patient or in an abscess cavity in a relatively quick and efficient manner.
[0004] The apparatus disclosed herein is an alternative embodiment to the previous apparatus disclosed in WO 2022/204169. Advantageously, this new apparatus effectively simplifies the procedure for placing the needle by eliminating the need for the stop locator of the previous apparatus and the step of prepositioning the stops along the length of the needle dependent upon the desired depth of penetration under the surface of the skin.
Summary
[0005] In accordance with the purposes and benefits set forth herein, a new and improved apparatus is provided for precisely placing a needle tip at a desired location under skin of a patient when using an ultrasound probe. The apparatus comprises, consists of or consists essentially of: (a) a needle guide including a plurality of needle guide apertures and (b) a support adapted for mounting the needle guide to the ultrasound probe wherein the plurality of needle guide apertures include inlets that are carried on a stop bar of the needle guide that extends substantially parallel to a scan axis of the ultrasound probe to which the needle guide is attached. [0006] In at least one of the many possible embodiments, the stop bar of the needle guide extends substantially perpendicular to a face of the acoustic lens of the ultrasonic probe that rides over the skin when precisely placing the needle tip at the desired location.
[0007] In at least one embodiment of the apparatus, the plurality of needle guide apertures are oriented in a row extending along a face of the stop bar. In at least one possible embodiment of the apparatus, the plurality of needle guide apertures are oriented at an angle A relative to the face of the stop bar. That angle A may be in the range of about 10° to about 70° degrees. Useful embodiments include, but are not necessarily limited to, angles of about 60°, about 45°, about 30°, and about 15°.
[0008] In at least some embodiments of the apparatus, the support includes a receiver for receiving and holding the needle guide. That receiver may include a socket and a release button.
[0009] The needle guide may include a projecting mount adapted for receipt in the receiver.
[0010] In at least some embodiments, the needle guide includes a first section and a second section that are interconnected at an interface extending through each of said plurality of needle guide apertures.
[0011] In accordance with yet another aspect, an apparatus for precisely placing a needle tip at a desired location under skin of a patient, comprises, consists of or consists essentially of: (a) an ultrasound probe adapted for sending and receiving sonic pulses along a scan plane extending from the ultrasound probe to a target anatomical structure, (b) a needle guide including a plurality of needle guide apertures, and (c) a support adapted for mounting the needle guide to the ultrasound probe wherein the plurality of needle guide apertures are carried on a stop bar of the needle guide that extends along a second plane that extends parallel to and offset from the scan plane.
[0012] The plurality of needle guide apertures may be oriented in a row extending along a face of the stop bar. Further, the plurality of needle guide apertures may be oriented at an angle A relative to the face of the stop bar. That angle A may be in the range of about 10° to about 70° degrees. Useful embodiments include, but are not necessarily limited to, angles of about 60°, about 45°, about 30°, and about 15°. The support may include a receiver for receiving and holding the needle guide. [0013] In accordance with yet another aspect, a method of precisely placing a needle tip at a target anatomical structure under skin of a patient when using an ultrasound probe, comprises, consists of or consists essentially of the steps of: (a) positioning the ultrasound probe against the skin of the patient over the target anatomical structure to determine a desired depth of needle penetration; (b) selecting a needle guide aperture from a plurality of needle guide apertures carried on a stop bar of a needle guide wherein (1) the needle guide is carried on the ultrasound probe, (2) the selected needle guide aperture corresponds to the desired depth of needle penetration under the skin of the patient at the target anatomical structure and (3) the stop bar extends substantially parallel to a scan axis of the ultrasound probe; and (c) inserting a needle into the selected needle guide aperture to precisely place the needle tip at the desired depth of penetration under the ultrasound probe.
[0014] In the following description, there are shown and described several different embodiments of the new and improved apparatus and method for precisely placing a needle tip at a target anatomical structure under skin of a patient when using an ultrasound probe. As it should be realized, the apparatus and method are capable of other, different embodiments and their several details are capable of modification in various, obvious aspects all without departing from the apparatus and method as set forth and described in the following claims. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not as restrictive.
Brief Description of the Drawing Figures
[0015] The accompanying drawing figures incorporated herein and forming a part of the specification, illustrate certain aspects of the new and improved apparatus and method and together with the description serve to explain certain principles thereof. A person of ordinary skill in the art will readily recognize from the following discussion that alternative embodiments of the apparatus and method may be employed without departing from the principles described below.
[0016] Figure 1 is a perspective view of a first possible embodiment of the apparatus including an ultrasound probe and a needle guide having a plurality of needle apertures extending at an angle of 45°. [0017] Figure 1 A is a view similar to Figure 1, but showing how a needle fully inserted through any one of the needle guide apertures will place the needle tip in the scan plane of the ultrasonic wave path at the desired depth of penetration.
[0018] Figure 2 is a detailed perspective view showing the inner face of the two cooperating sections of the needle guide illustrated in Figure 1.
[0019] Figure 3 is a perspective view of a first possible alternative embodiment of the apparatus including an ultrasound probe and a needle guide having a plurality of needle apertures extending at an angle of 60°.
[0020] Figure 4 is a detailed perspective view showing the inner face of the two cooperating sections of the needle guide illustrated in Figure 3.
[0021] Figure 5 is a perspective view of a second possible alternative embodiment of the apparatus including an ultrasound probe and a needle guide having a plurality of needle apertures extending at an angle of 15°.
[0022] Figure 6 is a detailed perspective view showing the inner face of the two cooperating sections of the needle guide illustrated in Figure 5.
[0023] Figure 7 is a detailed top plan view of the bracket used to secure any of the needle guides illustrated in Figures 1-6 to the ultrasound probe.
[0024] Figures 8A-8E illustrate step-by-step how to use the apparatus illustrated in Figures 1 and 2.
[0025] More specifically, Figure 8A is a detailed elevational view illustrating how the mounting end of any of the different needle guide is inserted into the receiver of the support.
[0026] Figure 8B is a similar view illustrating the needle guide connected to the support attached to the probe with the stop bar end oriented toward the viewer. [0027] Figure 8C is a detailed elevational view illustrating how the needle is inserted into an inlet one of the needle guide apertures at the stop bar end in order to ultimately place the needle in the desired location under the skin of the patient.
[0028] Figure 8D is a detailed side elevational view illustrating the final positioning of the needle guide into the vein of the patient in the scan plane of the ultrasound wave path extending from the ultrasound probe to a target anatomical structure/vein where proper positioning may be viewed and confirmed with the ultrasound probe.
[0029] Finally, Figure 8E is a detailed elevational view illustrating how the needle guide is released from the support by means of the release lever , the probe is removed and the needle guide separates from around the needle.
[0030] Reference will now be made in detail to the present preferred embodiments of the apparatus and method, examples of which are illustrated in the accompanying drawing figures.
Detailed Description
[0031] Reference is now made to Figures 1, 2, 7, and 8A-8E which illustrate a first possible embodiment of the apparatus 10 adapted for precisely placing a needle tip 36 at a desired location under the skin S of a patient when using an ultrasound probe 20. As illustrated in these Figures, the apparatus 10 may be considered to include a number of different components including, but not necessarily limited to: (a) a needle guide 12, (b) a support 14, (c) a syringe 16, (d) a needle 18, and (e) a probe 20, such as an ultrasound probe of a type known in the art.
[0032] The needle guide 12 may be made from any metal, plastic or composite material suitable for such a purpose. The needle guide 12 may be a single piece construction. Alternatively, as illustrated in Figure 2, the needle guide 12 may be made from two sections 38, 40 that are substantial mirror images of each other. The two sections 38, 40 may be interconnected along an interface 42 that extends through each needle guide aperture 28.
[0033] As best illustrated in Figure 2, 8 A and 8B, the needle guide 12 includes a mount 22 that forms a terminal projection. A plurality of needle guide apertures 28 extend through the needle guide 12. In the embodiment illustrated in Figures 1, 2, 7, 8 and 8A-8E, the plurality of needle guide apertures 28 are oriented in a single row and extend from inlets 29 on the stop bar 30, at the end of the needle guide opposite the mount 22, to open ends at the bottom wall 32 extending from the stop bar toward the mount. As should be appreciated, the stop bar 30 extends along a line L2 that is (a) substantially parallel to and offset from the scan axis LI of the ultrasound probe, (b) substantially perpendicular to a tangent T of the face of the acoustic lens 34 of the ultrasound probe 20 that rides over the skin during scanning and (c) aparallel to the skin S when scanning.
[0034] The needle guide apertures 28 may be oriented at any angle of between about l°-89° (more commonly between about 15°-60°) relative to the tangent T to the surface of acoustic lens 34 and extending substantially perpendicular to the scan axis LI and the ultrasonic wave generated by the probe 20 and emitted through the lens 34 (See Figure 1). In the embodiment illustrated in Figures 1, 2, 7, and 8A-8E, the needle guide apertures 28 extend at an angle of 45°. In the embodiment illustrated in Figures 3 and 4, the needle guide apertures 28 extend at an angle of 60°. In the embodiment illustrated in Figures 5 and 6, the needle guide apertures 28 extend at an angle of 15°. The user can select the needle guide 12 with needle guide apertures 28 extending along the best angle to accomplish the medical procedure at hand. For example, when targeting a smaller, more shallow vessel, it would be better to use a needle guide 12 with needle guide apertures 28 extending at a small angle of 15°, more parallel to the vessel, to place the needle tip 36 in that vessel.
[0035] As best illustrated in Figure 8B, each of the plurality of needle guide apertures 28 has an inlet 29 in the stop bar 30. Each also includes a graduation (not shown) indicating the depth of needle tip penetration of a fully inserted needle 18 relative to the face of the acoustic lens 34 of the probe 20 within the plane of the ultrasonic wave path P emanating from the probe 20. Thus, if one needs a depth of penetration of 1.5 cm to properly position the tip 36 of the needle 18 in a target vein V, one inserts the needle in the needle guide aperture 29 with a graduation for that depth. In contrast, if one needs a depth of penetration of 1.75 cm to properly position the tip 36 of the needle 18 in a target vein V, one inserts the needle in the needle guide aperture with a graduation for that depth. And so forth.
[0036] It should be appreciated that the distance from (a) any of the entry end openings 29 of the needle guide apertures 28 at the stop bar 30 to (b) the plane of the ultrasonic wave path P emanating from the probe 20 is the same. Accordingly, no matter which entry end opening 29 and needle guide aperture 28 is selected by the user, when the needle 18 is fully inserted, the tip 36 of the needle will lie in the plane of the ultrasonic wave path P. Thus, for example, as shown in Figure 1A, the needle 18A is fully inserted in the entry opening 29A of the needle guide aperture 28 A corresponding to a depth of DI at the plane of the ultrasonic wave path P. Similarly, the needle 18B is fully inserted in the entry opening 29B of the needle guide aperture 28B corresponding to a depth of D2 at the plane of the ultrasonic wave path P. All depths reflected by the graduations are depths from the face of the acoustic lens 34 of the probe 20.
[0037] As best illustrated in Figures 7 and 8A, the support 14 comprises a socket or receiver 42, adapted for receiving the mount 22, and two resilient locking arms 44, adapted for securing the support to the housing of the probe 20. More specifically, the support 14 is secured to the probe housing by passing the housing through the gap 48 between the ends of the resilient locking arms 44. The resilient arms 44 flex slightly outward to allow the housing to be fully seated in the cavity 50, provided between the arms, and then close, under the action of resilient memory, around the housing to securely fix the support on the housing. The assembled needle guide 12 is secured to the support 14 held on the housing of the probe 20 by simply plugging the mount 22 into the receiver 42 with a friction fit securing the needle guide in position on the support.
[0038] The needle guide 12 may be removed from the support 14 by manipulating the release button 52 pivotally mounted on the side of the receiver 42 by a pivot pin 54. More specifically, the release button 52 includes a finger pad 56 for engaging the button and two release lugs 58, 60. One release lug 58 is provided on one side of the receiver 42 (the upper side in drawing Figure 8E) and the other release lug 60 is provided on the opposite side (the lower side in the drawing Figure 8E) of the receiver 42. When the release button 52 is depressed (see action arrow A in Figure 8E) by pressing on the finger pad 56, the two release lugs 58, 60 pivot outwardly, engaging the margins of the needle guide 12 at two opposing sides adjacent the mount 22 and pushing the mount out of the receiver 42. Once the mount 22 is pushed out of the receiver 42, the two sections 38, 40 of the needle guide 12 separate and fall away from the needle 18 that was extending through the needle guide aperture 28, freeing the probe 20 and leaving the needle in place in the skin S of the patient.
[0039] Reference is now made to Figures 8A-8E which serve to illustrate the use of the apparatus 10 for purposes of the Seidinger Technique. For purposes of this explanation, the support 14 has been previously attached to the probe 22 in the manner described above. The probe 20 is then used, in a manner known in the art, to determine the desired depth for penetration of the tip 36 of the needle 18. For purposes of this explanation, let us assume that the probe 20 identifies the anatomical target as a vessel V with the center of the vessel located at 1.75 cm under the skin at the target site.
[0040] If not already done, the needle guide 12, with the desired needle angle, is attached to the support 14 secured to the probe 20 by inserting the projecting mount 22 into the receiver 42 carried on the support 14. This is done by aligning and then inserting the mount 22 into the receiver 42 to produce a snug friction fit. See Figure 8A and note action arrow B and also note Figure 8B illustrating the needle guide 12 attached to the support 14 secured to the probe 20.
[0041] With the probe 20 positioned against the skin S over the target site, the tip 36 of the needle 18 is inserted into the needle guide aperture 28 associated with the graduation (not shown) on the needle guide 12 indicating the desired penetration depth of 1.75 cm which corresponds to the depth at the center of the target vessel V. See Figure 8C.
[0042] The needle 18 is then pushed down (note action arrow C) through the selected needle guide aperture 28 until the resilient stop 64, carried on the needle 18 at the syringe collar 66, engages the stop bar 30 of the needle guide 12, at which time the tip 36 of the needle 18 may be visualized with the probe 20 at the desired depth at the target site with the tip located in the center of the vessel V. See Figure 8D. When the stop 64 engages the stop bar 30 of the needle guide 12, a resistance is provided to further penetration of the needle 18 under the skin S, giving the user of the apparatus 10 a clear tactile indication that the tip 36 of the needle is at the desired depth as may be confirmed on the probe monitor (not shown). If necessary for any reason, the needle 18 may be advanced further with additional resistance provided by the resilient stop 64.
[0043] Once the needle tip 36 is in the vessel V as confirmed by the stop 64 and the view on the probe monitor (not shown), one manipulates the plunger 68 of the syringe 16 in a manner known in the art to draw negative pressure. If the tip 36 of the needle 18 is properly located in the vessel V, this will serve to draw blood into the syringe 16, thereby confirming proper needle placement. [0044] As illustrated in Figure 8E, in order to release the needle guide 12 from the needle 18, one depresses the release button 52. See action arrow A. This shifts the probe 20 away from the needle guide 12 to free the mount 22 of the needle guide 12 from the receiver 42. As a result, the two sections 38, 40 of the needle guide 12 separate along the interface 42, freeing the needle 18 from the needle guide aperture 28.
[0045] The syringe 16 is then removed from the needle 28 in a manner known in the art. A guidewire (not shown) may then be advanced through the needle 18 and into the vessel V in a manner known in the art. Once this guidewire is in place, the needle 18 is removed off of the wire, and a catheter, dilator or sheath, of a type known in the art and not shown, is then advanced over the guidewire into the vessel. The guidewire is then removed and the desired catheter, dilator or sheath remains in the vessel V, so other procedures, such as blood draw, medication administration, or endovascular procedures, may be carried out.
[0046] While the use described above relates to the Seidinger Technique, it should be appreciated that the apparatus 10 may be used for other applications such as simple injection, biopsy, drainage of an abscess cavity or various other medical uses associated with syringes and needles.
[0047] This document may be said to relate to the following items.
1. An apparatus for precisely placing a needle tip at a desired location under skin of a patient when using an ultrasound probe, comprising: a needle guide including a plurality of needle guide apertures; and a support adapted for mounting the needle guide to the ultrasound probe; wherein the plurality of needle guide apertures include inlets that are carried on a stop bar of the needle guide that extends substantially parallel to a scan axis of the ultrasound probe to which the needle guide is attached.
2. The apparatus of claim 1, wherein the stop bar of the needle guide extends substantially perpendicular to a face of an acoustic lens of the ultrasonic probe that rides over the skin when precisely placing the needle tip at the desired location.
3. The apparatus of item 1, wherein the plurality of needle guide apertures are oriented in a row extending along a face of the stop bar. 4. The apparatus of item 3, wherein the plurality of needle guide apertures are oriented at an angle A relative to the face of the stop bar.
5. The apparatus of item 4, wherein the angle A is about 45°.
6. The apparatus of item 4, wherein the support includes a receiver for receiving and holding the needle guide.
7. The apparatus of item 6, wherein the receiver includes a socket and a release button.
8. The apparatus of item 7, wherein the needle guide includes a projecting mount.
9. The apparatus of item 1, wherein the needle guide includes a first section and a second section that are interconnected at an interface extending through each of said plurality of needle guide apertures.
10. An apparatus for precisely placing a needle tip at a desired location under skin of a patient, comprising: an ultrasound probe adapted for sending and receiving sonic pulses along a scan plane extending from the ultrasound probe to a target anatomical structure; a needle guide including a plurality of needle guide apertures; and a support adapted for mounting the needle guide to the ultrasound probe; wherein the plurality of needle guide apertures are carried on a stop bar of the needle guide that extends along a second plane that extends parallel to and offset from the scan plane.
11. The apparatus of item 10, wherein the plurality of needle guide apertures are oriented in a row extending along a face of the stop bar.
12. The apparatus of item 11, wherein the plurality of needle guide apertures are oriented at an angle A relative to the face of the stop bar.
13. The apparatus of item 12, wherein the angle A is about 45°. 14. The apparatus of item 13, wherein the support includes a receiver for receiving and holding the needle guide.
15. A method of precisely placing a needle tip at a target anatomical structure under skin of a patient when using an ultrasound probe, comprising: positioning the ultrasound probe against the skin of the patient over the target anatomical structure to determine a desired depth of needle penetration; selecting a needle guide aperture from a plurality of needle guide apertures carried on a stop bar of a needle guide wherein (a) the needle guide is carried on the ultrasound probe, (b) the selected needle guide aperture corresponds to the desired depth of needle penetration under the skin of the patient at the target anatomical structure and (c) the stop bar extends substantially parallel to a scan axis of the ultrasound probe; and inserting a needle into the selected needle guide aperture to precisely place the needle tip at the desired depth of penetration under the ultrasound probe .
16. The method of item 15, including attaching the needle guide to the ultrasound probe prior to the positioning of the ultrasound probe against the skin.
17. The method of item 16, further including orienting the stop bar at an angle substantially perpendicular to a face of the acoustic lens of the ultrasonic probe that rides over the skin when precisely placing the needle tip at the desired location.
[0048] Each of the following terms written in singular grammatical form: “a”, “an”, and “the”, as used herein, means “at least one”, or “one or more”. Use of the phrase “One or more” herein does not alter this intended meaning of “a”, “an”, or “the”. Accordingly, the terms “a”, “an”, and “the”, as used herein, may also refer to, and encompass, a plurality of the stated entity or object, unless otherwise specifically defined or stated herein, or, unless the context clearly dictates otherwise. For example, the phrase: “a needle guide”, as used herein, may also refer to, and encompass, a plurality of needle guides.
[0049] Each of the following terms: “includes”, “including”, “has”, “having”, “comprises”, and “comprising”, and, their linguistic / grammatical variants, derivatives, or/and conjugates, as used herein, means “including, but not limited to”, and is to be taken as specifying the stated component(s), feature(s), characteristic(s), parameter(s), integer(s), or step(s), and does not preclude addition of one or more additional component(s), feature(s), characteristic(s), parameter(s), integer(s), step(s), or groups thereof.
[0050] The phrase “consisting of’, as used herein, is closed-ended and excludes any element, step, or ingredient not specifically mentioned. The phrase “consisting essentially of’, as used herein, is a semi-closed term indicating that an item is limited to the components specified and those that do not materially affect the basic and novel character! stic(s) of what is specified.
[0051] Terms of approximation, such as the terms about, substantially, approximately, etc., as used herein, refers to ± 10 % of the stated numerical value.
[0052] Although the apparatus and method of this disclosure have been illustratively described and presented by way of specific exemplary embodiments, and examples thereof, it is evident that many alternatives, modifications, or/and variations, thereof, will be apparent to those skilled in the art. For example, the apparatus 10 need not include any bumper or stop 64 on the needle 18. Accordingly, it is intended that all such alternatives, modifications, or/and variations, fall within the spirit of, and are encompassed by, the broad scope of the appended claims.