Probe guard

Abstract

This document discloses a needle shield for an ultrasound probe. The shield fits snugly with the ultrasound probe head and any associated structures, protecting it from accidental damage such as needlesticks. Furthermore, the shield includes a guide wedge that allows the user to stabilize the probe at an angle relative to the skin surface. This allows the needle to enter the target vessel perpendicularly without the probe obstructing the needle. Furthermore, the shield includes an acoustic lens to modify the acoustic beam and compensate for the angular position of the probe head.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 910,263, filed on October 3, 2019, the entire contents of which are incorporated herein by reference. Background Art Technical Field

[0003] The present invention relates to the field of medical devices, and more particularly to a probe shield. Summary of the Invention

[0004] In brief overview, embodiments disclosed herein relate to a needle shield for use with an ultrasound ("U / S") probe head to protect the ultrasound transducer and any associated structures from accidental damage from the needle.

[0005] Ultrasound imaging systems are used to facilitate vascular access under ultrasound image guidance. To improve acoustic communication between the transducer located in the ultrasound probe head and the patient's skin surface, the probe head often includes various additional structures, such as a cover, a hydrogel spacer, and the like. Such structures are optimized for delivering acoustic energy and are therefore not necessarily formed of a material that resists damage from accidental needle sticks. When the ultrasound probe head is held against the patient's skin surface, a needle for accessing the vascular system is inserted adjacent to the ultrasound probe head. This is often performed while the clinician is viewing a console or display that is arranged away from the insertion site. Therefore, there is a risk that the needle may be accidentally inserted into the probe head or associated structures, causing significant damage to the probe head, the transducer, or associated structures.

[0006] Disclosed herein is an ultrasound system including a probe comprising a body and a probe head, the needle shield engaging a portion of the probe head to secure the needle shield to the probe head, the needle shield comprising one or more side portions formed as a single structure and defining a thickness between 1 mm and 5 mm, the needle shield formed of a first material that is impenetrable by a needle and defines a first acoustic impedance.

[0007] In some embodiments, the needle shield includes an acoustic surface cover disposed on the acoustic surface of the probe head; a first lateral side extending from the acoustic surface cover and engaging a first lateral side surface of the probe head; and a second lateral side extending from the acoustic surface opposite the first lateral side surface and engaging a second lateral side surface of the probe head.

[0008] In some embodiments, the needle shield includes an acoustic surface shield disposed on the acoustic surface of the probe head; a first lateral side extending from the acoustic surface shield and engaging a first lateral side surface of the probe head; a second lateral side extending from the acoustic surface opposite the first lateral side surface and engaging a second lateral side surface of the probe head; a first transverse side extending from the acoustic surface shield and engaging a first transverse side surface of the probe head; and a second transverse side extending from the acoustic surface opposite the first transverse side surface and engaging the second transverse side surface of the probe head. The needle shield further includes an aperture disposed in the acoustic surface shield, the aperture exposing a portion of the acoustic surface of the probe head to the patient's skin surface.

[0009] In some embodiments, the needle shield includes an acoustic surface cover disposed on the acoustic surface of the probe head; a first lateral side extending from the acoustic surface cover and engaging a first lateral side surface of the probe head; and a second lateral side extending from the acoustic surface opposite the first lateral side surface and engaging a second lateral side surface of the probe head.

[0010] In some embodiments, the needle shield is secured to the probe head by one of mechanical interference, engagement of a protrusion with a stopper, engagement of a protrusion with a hole, and an adhesive. The needle shield further includes a guide wedge disposed on a side portion of the one or more side portions and including a guide surface that contacts the patient's skin surface. The guide surface is angled relative to the acoustic surface of the probe head so that the probe extends longitudinally at a predetermined angle relative to the vertical axis. The predetermined angle is 20°. The guide surface includes an acoustic lens. The acoustic lens is formed of a second material that defines a second acoustic impedance.

[0011] Also disclosed herein is a method for accessing a patient's vascular system under ultrasound image guidance, the method comprising providing a needle, an ultrasound imaging system (including an ultrasound probe, the probe including a body and a probe head), and a needle shield (configured to engage a portion of the probe head), the needle shield including one or more side portions and a guide wedge, the needle shield formed of a first material that is impenetrable by the needle and defines a first acoustic impedance, pushing the needle shield onto the probe head, imaging a subcutaneous portion of the patient to identify a target vessel by: placing a guide surface of the guide wedge against a skin surface of the patient such that a longitudinal axis of the probe is at a predetermined angle relative to a vertical axis extending perpendicular to the skin surface of the patient; and accessing the target vessel using the needle by penetrating the skin surface parallel to the vertical axis.

[0012] In some embodiments, the needle shield includes an acoustic lens that redirects the acoustic beam from the probe head to align with the vertical axis. The acoustic lens includes a concave structure disposed in the guide surface of the guide wedge. The acoustic lens includes a second material that defines a second acoustic impedance, the second material disposed in the guide surface of the guide wedge. The predetermined angle is between 0° and 45° from the vertical axis. The predetermined angle is 20° from the vertical axis.

[0013] These and other features of the concepts provided herein will become more readily apparent to those skilled in the art in view of the accompanying drawings and the following description, which disclose in more detail certain embodiments of such concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1A An exemplary ultrasound system according to embodiments disclosed herein is presented.

[0015] Figure 1B An exemplary ultrasound probe including a needle shield according to embodiments disclosed herein is shown.

[0016] Figures 2A to 2D An ultrasound probe head including an exemplary embodiment of a needle shield according to embodiments disclosed herein is shown.

[0017] Figure 3A A cross-sectional view of an ultrasound probe including an exemplary needle shield according to embodiments disclosed herein is shown.

[0018] Figure 3B A cross-sectional view of an ultrasound probe including an exemplary needle shield according to embodiments disclosed herein is shown. DETAILED DESCRIPTION

[0019] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the features of the specific embodiments disclosed herein can be easily separated from the specific embodiments and optionally combined or substituted with the features of any one of the multiple other embodiments disclosed herein.

[0020] About the term used in this article, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concept provided herein. Ordinal number (for example, first, second, third etc.) is usually used to distinguish or identify the different features or different steps in a set of features or a set of steps, and does not provide sequence or numerical limitation. For example, "first", "second" and "third" features or steps do not necessarily need to appear in this order, and the specific embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "up", "down", "front", "back" etc. are for convenience of use, rather than being intended to imply such as any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect such as relative position, orientation or direction. Unless otherwise clearly indicated in context, singular form "one", "a kind of" and "the" include plural references.

[0021] For example, when the probe is used on a patient, the "proximal side," "proximal portion," or "proximal end portion" of a probe disclosed herein includes the portion of the probe that is intended to be close to a clinician when the probe is used on a patient. Similarly, for example, when the probe is used on a patient, the "proximal length" of the probe includes the length of the probe that is intended to be close to a clinician when the probe is used on a patient. For example, when the probe is used on a patient, the "proximal end" of the probe includes the end of the probe that is intended to be close to a clinician when the probe is used on a patient. The proximal portion, proximal end portion, or proximal length of the probe may include the proximal end of the probe; however, the proximal portion, proximal end portion, or proximal end length of the probe need not include the proximal end of the probe. That is, unless the context indicates otherwise, the proximal portion, proximal end portion, or proximal length of the probe is not the distal portion or distal length of the probe.

[0022] For example, when the probe is used on a patient, reference to the "distal side," "distal portion," or "distal end portion" of a probe disclosed herein includes the portion of the probe that is intended to be near or in the patient when the probe is used on a patient. Similarly, for example, reference to the "distal length" of the probe includes the length of the probe that is intended to be near or in the patient when the probe is used on a patient. For example, reference to the "distal end" of the probe includes the end of the probe that is intended to be near or in the patient when the probe is used on a patient. The distal portion, distal end portion, or distal length of the probe may include the distal end of the probe; however, the distal portion, distal end portion, or distal length of the probe need not include the distal end of the probe. That is, unless the context indicates otherwise, the distal portion, distal end portion, or distal length of the probe is not the terminal portion or terminal length of the probe.

[0023] As shown in FIG1 , and to aid in describing the components of the embodiments described herein, the probe is depicted as being held vertically while holding an acoustic surface against a horizontal surface. The longitudinal axis extends perpendicular to the acoustic surface. The acoustic surface is defined by a lateral axis and a transverse axis, wherein the lateral axis extends orthogonal to the longitudinal axis and the transverse axis extends orthogonal to both the lateral axis and the longitudinal axis. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0024] Figures 1A to 1B An exemplary embodiment of an ultrasound imaging system 10 is shown, which generally includes an ultrasound probe 12 and a console 20 including a display 30 for depicting images produced by the probe 12. In an embodiment, the probe 12 is operably connected to the console 20 via a cable 31, although in embodiments, the probe may be connected to the console 20 wirelessly.

[0025] The probe 12 includes a head portion ("probe head" or "head") 32 defined by a lateral length 32A and a transverse width 32B. The head 32 includes an acoustic surface 34 extending along at least a portion of the lateral length 32A of the probe head, from which ultrasound pulses are emitted by a transducer disposed within the probe head 32 so as to penetrate and image the subcutaneous portion of the patient. Note that the size, shape, and configuration of the probe 12, probe head 32, transducer, and acoustic surface 34 may vary from that described herein while remaining within the principles of the present disclosure. Note also that Figures 1A to 1B An exemplary ultrasound imaging system is shown; other systems, including other components, may also benefit from the principles described herein.

[0026] like Figure 1B As shown in FIG, the probe head 32 can further include a needle shield 100. The needle shield 100 can be coupled to the probe head 32 or a portion thereof and cover a portion of the probe head 32. In an embodiment, the needle shield 100 is formed of a resilient material that resists penetration from the needle. In an embodiment, the needle shield 100 is formed of a material that is transparent to acoustic energy that passes through the needle shield 100 (as transmitted energy from the transducer or as reflected energy received by the transducer).

[0027] In an embodiment, the needle shield 100 is formed of an elastic material such as plastic, polymer, metal, etc., which resists penetration from the needle and is substantially rigid. The needle shield 100 defines a substantially uniform thickness between 0.25 mm and 5 mm (e.g., 1 mm). The needle shield conforms to the outer contour of the probe head 32 and any associated covers, septa, etc. to provide a protective layer thereon. As used herein, the needle shield is described as operating in conjunction with the probe head 32. However, it will be understood that the probe head may further include various covers, needle guides, septa, and other additional structures. Therefore, the needle shield 100 can be formed to operate in conjunction with both the probe head and these additional structures to form a protective barrier thereon.

[0028] In an embodiment, the needle shield 100 is coupled to the probe head 32 and is secured to the probe head 32 by mechanical interference with the probe head 32. For example, Figure 1B 、 2A 2D , a first lateral proximal edge 102 of the needle shield 100 cooperates with a concave portion of the probe head 32. Further, although the needle shield is formed of a substantially rigid material, it is flexible enough so that the proximal edge 102 can be urged against the probe head 32 and clamped in place, thereby securing the needle shield 100 to the probe head 32. As shown in FIG. 3 , a second lateral proximal edge 106, opposite the first lateral proximal edge 102, provides an opposing force and secures the needle shield 100 to the probe head 32.

[0029] In an embodiment, the needle shield 100 is coupled to the probe head 32 and is secured to the probe head 32 by means of interengaging protrusions and detents. Figure 2A 、 2DAs shown in FIG, the probe head 32 includes one or more protrusions 110, guide hooks, or similar protruding structures disposed on a surface of the probe 12, the probe head 32, or a combination thereof. The needle shield 100 includes one or more detents 112, holes, or a combination thereof that engage the one or more protrusions 110 to secure the needle shield 100 thereto. As described herein, the needle shield 100, while formed from a substantially rigid material, is sufficiently flexible so that the needle shield 100 can be pushed against the protrusions 110 disposed on the probe head 32 so that corresponding detents 112, holes, or the like can engage the protrusions 110 and secure the needle shield 100 to the probe head 32. While an embodiment has been described in which the protrusions 110 are disposed on the probe head 32, it should be understood that the protrusions 110 may be disposed on the needle shield 100, the probe head 32, or a combination thereof without departing from the spirit of the present invention. Similarly, the aperture / stop 112 may be disposed on the probe head 32, the needle shield 100, or a combination thereof without departing from the spirit of the present invention.

[0030] In an embodiment, the needle shield 100 is coupled with the probe head 32 and secured to the probe head 32 using an adhesive layer disposed between the needle shield 100 and the probe head 32 .

[0031] Figures 2A to 2D Various embodiments of the needle shield 100 are shown. Figure 2A In the embodiment shown in FIG, needle shield 100 includes an acoustic surface cover portion 120 covering the acoustic surface 34 of the probe head. Extending from the acoustic surface cover portion 120 are first and second lateral side portions 122, 126 extending on respective lateral sides of the probe head 32.

[0032] like Figure 2B , in an embodiment, the needle shield 100 includes a first lateral side portion 122, a second lateral side portion 126, a first lateral side portion 124, and a second lateral side portion 128 extending on respective lateral and transverse sides of the probe head 32. The needle shield 100 further includes an aperture 130 aligned with the acoustic surface 34.

[0033] like Figure 2C As shown in FIG, in an embodiment, the needle shield 100 includes an acoustic surface cover portion 120 that covers the acoustic surface 34 of the probe head. Extending from the acoustic surface cover portion 120 are a first lateral side portion 122, a second lateral side portion 126, a first lateral side portion 124, and a second lateral side portion 128 that extend on respective lateral and transverse sides of the probe head 32.

[0034] like Figure 2DIn the embodiment shown in FIG, needle shield 100 includes an acoustic surface cover portion 120 covering the acoustic surface 34 of the probe head. Extending from the acoustic surface cover portion 120 are first and second lateral side portions 124, 128 extending on respective lateral sides of the probe head 32.

[0035] like Figures 3A to 3B As shown in FIG, in an embodiment, the needle shield 100 further includes a guide wedge 140. The guide wedge 140 includes a portion of the needle shield (the portion defining a greater thickness than the remaining portion of the needle shield 100) and a smooth outer contour that is continuous with the outer contour of the needle shield 100. The guide surface 142 of the guide wedge 140 is aligned with the patient's skin surface and is angled relative to the acoustic surface 34 to support the probe 12 at a predetermined angle. For example, as shown in FIG. Figure 3A As shown in FIG, the guide surface 142 is substantially parallel to the acoustic surface 34 and supports the probe 12 in a substantially vertical orientation. Figure 3B As shown in FIG, the guide surface 142 can be angled relative to the acoustic surface 34 and support the probe at a predetermined angle "θ" relative to a vertical axis that extends perpendicular to the patient's skin surface. The predetermined angle "θ" can be between 0° and 45° from the vertical axis, for example, approximately 20° from the vertical axis.

[0036] Advantageously, the guide wedge 130 can support the probe 12 so that it does not hinder access to the vessel 50. Many surgeries require access to the vessel perpendicular to the skin surface. However, most ultrasound transducers are designed to be held perpendicular to the skin surface, which hinders access to the vessel 50. Therefore, the needle shield 100 including the guide wedge 130 can position the probe to one side while maintaining a stable angle. Optionally, the probe head 32 can further include a needle guide or similar structure.

[0037] In an embodiment, the needle shield includes an acoustic lens 150 that focuses the energy emitted from the transducer to a predetermined focal point. Figure 3B As shown in FIG, the probe 12 can be angled relative to the skin surface to allow the needle 60 to enter the vessel 50 perpendicular to the skin surface. As a result, the direction of the acoustic beam emitted from the transducer is also angled relative to the skin surface. These angled beams may hinder the clarity and accuracy of the ultrasound system 10 by introducing refraction or deflection elements to the beam characteristics at the skin surface. Therefore, the needle shield 100 includes an acoustic lens 150 arranged on the guide surface 142 to correct the angled position of the probe 12 relative to the skin surface.

[0038] In an embodiment, the needle shield 100 can be formed from a single material, and the acoustic lens 150 can include a concave structure disposed on the guide surface. In an embodiment, the acoustic lens includes a portion of a second material that is different from the first material forming the needle shield 100. For example, the needle shield can be formed from a first rigid material that defines a first acoustic impedance, and the acoustic lens includes a portion of the second material that defines a second acoustic impedance. It should be understood that the size, shape, location, and number of acoustic lenses can vary from that shown and still fall within the scope of the present invention. Further, the acoustic impedance of the first material can be greater than or less than the acoustic impedance of the second material and still fall within the scope of the present invention.

[0039] Although some specific embodiments have been disclosed herein, and although some details of specific embodiments have been disclosed, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications will be apparent to those skilled in the art and are encompassed in the broader aspects. Therefore, departures may be made from the specific embodiments provided herein without departing from the scope of the concepts disclosed herein.

Claims

1. An ultrasound system comprising: a probe comprising a main body and a probe head; and a needle shield engaging a portion of the probe head to secure the needle shield to the probe head, the needle shield comprising one or more side portions formed as a unitary structure and defining a thickness between 1 mm and 5 mm, the needle shield being formed of a first material that is impenetrable by a needle and defines a first acoustic impedance, wherein the needle shield further comprises a guide wedge disposed on a side portion of the one or more side portions and comprising a guide surface in contact with a skin surface of the patient, Wherein the guide surface is angled relative to the acoustic surface of the probe head such that the probe extends longitudinally at a predetermined angle relative to a vertical axis.

2. The ultrasound system of claim 1 , wherein the needle shield comprises: an acoustic surface cover, which is arranged on the acoustic surface of the probe head; a first lateral side extending from the surface acoustic shield and engaging a first lateral side surface of the probe head; and A second lateral side extends from the acoustic surface opposite the first lateral side surface and engages a second lateral side surface of the probe head.

3. The ultrasound system of claim 1 , wherein the needle shield comprises: an acoustic surface cover, which is arranged on the acoustic surface of the probe head; a first lateral side extending from the surface acoustic shield and engaging a first lateral side surface of the probe head; a second lateral side extending from the acoustic surface opposite the first lateral side surface and engaging a second lateral side surface of the probe head; a first lateral side extending from the surface acoustic shield and engaging a first lateral side surface of the probe head; and A second lateral side extends from the acoustic surface opposite the first lateral side surface and engages a second lateral side surface of the probe head. 4 . The ultrasound system of claim 3 , wherein the needle shield further comprises a hole disposed in the acoustic surface cover, the hole exposing a portion of the acoustic surface of the probe head to the skin surface of the patient.

5. The ultrasound system of claim 1 , wherein the needle shield comprises: an acoustic surface cover, which is arranged on the acoustic surface of the probe head; a first lateral side extending from the surface acoustic shield and engaging a first lateral side surface of the probe head; and A second lateral side extends from the acoustic surface opposite the first lateral side surface and engages a second lateral side surface of the probe head.

6. The ultrasound system of any one of claims 1 to 5, wherein the needle shield is secured to the probe head by one of mechanical interference, engagement of a protrusion with a stopper, engagement of a protrusion with a hole, and an adhesive. The ultrasound system according to claim 1 , wherein the predetermined angle is 20°.

8. The ultrasound system of claim 1, wherein the guide surface comprises an acoustic lens.

9. The ultrasound system of claim 8, wherein the acoustic lens is formed of a second material defining a second acoustic impedance.

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