Needle aligner for image-guided intravenous procedures

Abstract

Improvements in image-guided intravenous procedures are provided. A needle aligner for aligning a needle with an imaging probe is provided. The needle aligner comprises a housing configured to be secured to the probe; and needle guide part which is attached to the housing and positionable relative thereto, the needle guide part comprising at least one needle guide configured to receive a needle and guide the needle along the guide so as to constrain the needle's movement. A probe holder is also provided. The probe holder comprises gripping means configured to hold an imaging probe relative to an axis of rotation; and a rotation mechanism configured to rotate the gripping means around the axis of rotation.

Description

NEEDLE ALIGNER FOR IMAGE-GUIDED INTRAVENOUS PROCEDURESTECHNICAL FIELD

[0001] The present invention relates to a device for performing ultrasound guided procedures used in medical and healthcare for diagnosing an image of a living body (including a human body) using ultrasonic waves, and more particularly to an ultrasound probe stabilizer with a needle aligner that can be used for various ultrasound guided procedures such as placing an intravenous cannula, biopsy and nerve blocks.BACKGROUND

[0002] Finding a blood vessel for sampling or injecting a chemical into a patient is a complicated procedure that must always be carried out by trained individuals. However, even for experienced staff, finding a vein or artery in the presence of a rather damaged or challenging vascular structure brought on by low patient blood pressure values (syncope or shock) can be a very challenging task, particularly in scenarios involving medical and / or domestic issues. Additionally, simply being able to see the vein and / or artery does not allow for easy collection or cannulation. According to the research of established medical colleges and universities the ability to see the vessel, its size, and the restriction of the vessel's movement during the puncture of the wall are three key requirements for performing venous, arterial, and vascular cannulation correctly.

[0003] Imaging, in particular ultrasound imaging, can be used to visualise the blood vessel and the needle during insertion of the needle into the blood vessel. An ultrasound imaging probe will, typically, provide a two-dimensional image which is a cross-section of the imaged tissue within an ‘imaging plane’, which is a plane which extends away from the imaging probe. In an ultrasound guided intravenous procedure (i.e. inserting a needle into a blood vessel) the imaging probe will be used to locate a blood vessel. The imaging plane must then be carefully brought into alignment with the long axis of the blood vessel. The needle must then be inserted such that it is within the imaging plane and can be viewed in the image. At this point, the needle can be further inserted, with the needle and the blood vessel being simultaneously visualised in the ultrasound image suchthat the insertion of the needle into the blood vessel can be performed whilst both are visualised in the image.

[0004] However, training and skill are required to correctly position the probe and maintain the stability of its position as it is moved across the patient’s skin and rotated between positions. Moreover, even with experience and training it can be challenging to properly align the needle with the imaging plane at the point of inserting it into the patient’s skin.

[0005] It is known in the prior art to provide probe holders, and / or to use needle guides which are fixed in some manner to an imaging probe. However, devices of the prior art are generally not retrofittable and cannot be used with varying shapes and sizes of the probes. Further, in conventional systems, the probes also lack stability while in operation. Furthermore, the conventional probe clamp assemblies have limited freedom of rotation which disables the complete view of all vessels within a patient’s tissue. Moreover, conventional probe clamp assemblies require a separate needle aligner for inserting cannula or injecting medicines and also lack sterility / infection control as they cannot prohibit direct contact of the probe with the patient’s skin.

[0006] Therefore, there is still a need for an enhanced ultrasound device that addresses one or more of the aforementioned drawbacks without compromising its benefits and functionality.SUMMARY OF THE INVENTION

[0007] An aspect of the invention provides a needle aligner for aligning a needle with the imaging plane of an imaging probe, comprising a housing; and a needle guide part which is attached to the housing and positionable relative thereto, the needle guide part comprising at least one needle guide configured to receive a needle and guide the needle along the guide so as to constrain the needle’s movement.

[0008] In this way, the needle aligner can be attached to an imaging probes, and the movement of the needle will be constrained in a particular direction relative to the needleprobe. This allows the needle to be constrained to move in the imaging plane of the needle probe, facilitating ultrasound-guided insertion of a needle into a patient.

[0009] The imaging plane of the imaging probe is defined as the plane extending from the probe in which the probe records images. For ultrasound probes, the imaged volume is typically defined by a cuboid with a width and length much greater than the height. The imaging plane is therefore defined as the plane delineated by the two longer width and length axes.

[0010] Further, the housing may be secured to different imaging probes, and, because the needle guide part is positionable relative to the housing, the needle guide can be brought into the correct alignment with the imaging plane of the particular needle probe to which the needle aligner is attached. This allows the needle aligner to provide a ‘universal’ needle aligner, which can be used with a variety of probes, and which can account for any variation (even between probes of the same model) in the position and direction of the imaging plane of the imaging probe. In this embodiment, and in all other aspects and embodiments of the invention, the imaging probe may, in particular, be an ultrasound imaging probe.

[0011] In some embodiments, the at least one needle guide comprises a groove, preferably wherein the groove is a v-shaped groove.

[0012] By ‘ groove’, it is to be understood that the needle guide is open on its side which, in use, will face the patient’s skin. A needle guide in the form of a groove allows the needle aligner to be lifted away from the patient after the needle has been inserted. By ‘v-shaped’ groove, it will be understood that the groove has a configuration in which it is wider at the side which in use will face the patient’s skin, and narrow at the opposing side of the groove. A groove with this configuration allows for needles of different sizes (or ‘gauges’) to be inserted using the needle guide, meaning that a single needle aligner can be used to guide the insertion of different size needles.

[0013] In some embodiments the needle guide part comprises a plurality of needle guides, respectively sized to receive different sized needles, preferably wherein the plurality of needle guides are disposed on a wheel which can be rotated.

[0014] By providing multiple needle guides of different sizes, it is possible to accommodate a different sized needles with a single needle guide part. Because the needle guide is positionable with respect to the housing (and in turn the probe to which it is secured), the required needle guide part can be brought into alignment with the imaging plane of the imaging probe. Additionally, or alternatively, disposing the plurality of needle guides on a rotatable wheel allows for a different one of the needle guides to be brought into a position which, in use, would face the skin of the patient, thereby allowing the user to select a needle guide suitable for the needle to be inserted into the patient.

[0015] In some embodiments, the housing comprises a support, and the needle guide part is disposed on the support and is slidable along the support.

[0016] By way of the needle guide part being slidable along the support, the needle guide can be brought into alignment with the plane of the imaging plane of the probe.

[0017] In some embodiments, the support is configured to permit movement of the needle guide part along the axis of the support such that the needle guide can be brought into alignment with the imaging plane of the probe.

[0018] In some embodiments, the needle guide part is configured to rotate about the support. This allows the user to change the angle of the needle with respect to the patient a plane perpendicular to the skin by simply rotating the needle guide part.

[0019] In some embodiments the support comprises a first and a second axle diametrically opposed either side of the groove, wherein the first and second axles are fixedly coupled to the needle guide part and rotatably coupled to the housing.

[0020] In some embodiments, the linear axis defined by the support intersects the v- shaped groove. The advantageously allows rotation of the needle guide part to exactly correspond to a change in angle of the needle.

[0021] In some embodiments, the support interfaces the needle guide part at approximately the midpoint of the longitudinal axis of the needle guide part perpendicular to the axis of the support.

[0022] In some embodiments, the needle guide part is a base plate which is adjustably connected to the housing.

[0023] In some embodiments, the base plate is slidably connected to the housing, preferably by means of a projection on one of the base plate and the housing which is constrained in a groove in the other one of the base plate and the housing.

[0024] Providing a needle guide part in the form of base plate which is slidably connected to the housing allows for the relative position of the needle guide to be easily yet securely adjusted relative to the imaging probe.

[0025] In some embodiments, the position of the base plate relative to the housing can be adjusted by means of and incremental adjustment mechanism, such as an adjustment screw.

[0026] Providing an incremental adjustment means, such as an adjustment screw, allows for the position of base plate (and in turn the needle guide) to be precisely adjusted relative to the probe.

[0027] In some embodiments, the housing comprises a probe slot to receive the probe.

[0028] The slot may be sized and / or shaped to receive a probe of a corresponding size and / or shape. The slot may have a degree of resilience, for example comprising cushioned walls. This way the needle aligner can be easily secured to the probe.

[0029] In some embodiments, the housing comprises a clasp mechanism to secure the probe.

[0030] In some embodiments, the clasp mechanism comprises one or more bands of elastic material (such as rubber, neoprene, silicone, or other elastic polymers) configured to secure the probe in place relative to the housing.

[0031] In some embodiments, the clasp mechanism comprises a first and second clamp part, positionable relative to each other, such that the imaging probe can be secured therebetween. In some embodiments, the first and second clamp part are biased toward each other to secure the imaging probe therebetween. In some embodiments, the needle aligner comprises an adjustment means, preferably one or more adjustment screws, for moving the first and second clamp part toward each other to secure the imaging probe therebetween.

[0032] Providing a clasp mechanism in the form of a first and second clamp allows for the probe to be clasped and secured in the housing being centred around a particular position within the housing. This way, different size imaging probes can be accommodated in the needle aligner, and secured in the housing such that the imaging plane (which generally corresponds to a central axis of the imaging probe) will be aligned in roughly the same position within the housing. In turn, the adjustment to the position of the needle guide part relative to the housing can be kept to a minimum.

[0033] In some embodiments, the needle aligner further comprises at least one finger loop.

[0034] A ‘finger loop’ is to be understood to be a feature which is sized to receive one or more fingers of the user, thereby allowing them to stabilise the needle aligner without grasping it. The finger loop may be a fully closed loop or may be an open loop. It may be attached to the housing or to the needle guide part. Preferably, it is attached by way of a pivotable connection.

[0035] By way of the finger loop, the user is able to stabilise and position the probe relative to the patient’s skin without having to fully grasp the probe. In use, each finger loop allows for the probe to be suspended from one finger of the user. The user’s other fingers are free to manipulate one end of the probe, pivoting the probe to manipulate the probe to accurately tilt and position the probe. Compared to grasping the imaging probe with the whole hand, the use of a finger loop allows for very fine movements of the probe for precise alignment with the blood vessel within the patient.

[0036] In some embodiments, the needle guide part comprises a needle blank, for example a length of metal with a similar thickness to the needle, the needle blank being held in a fixed position aligned to the axis of the needle guide.

[0037] As used herein a ‘needle blank’ refers to any element provided in the needle guide which acts as an analogue for the needle which will be inserted using the needle aligner. For example, where the imaging probe is an ultrasound imaging probe, the needle blank is any element with a similar size and ultrasound reflectivity as a needle (or part thereof). Because the needle blank is aligned with the axis of the needle guide, the needle guide part can be positioned relative to the housing (and in turn the probe) with the needle blank visible in the images provided by the imaging probe. In turn, this allows the needle guide axis to be aligned with the image plane of the imaging probe without resting a needle on the needle guide itself.

[0038] In some embodiments, the housing comprises at least one stabiliser flap extending away from the centre of the housing and providing an extended surface configured to, in use, abut the skin of the patient.

[0039] In some embodiments, the extended surface has a curved configuration to provide a stable interface with the limb of a patient.

[0040] In some embodiments, the at least one stabiliser flap is a band configured to surround a limb of the patient.

[0041] In some embodiments, the extended surface may be provided with a temporary adhesive to facilitate adherence of the needle aligner to the skin of the patient.

[0042] By providing a curved configuration and / or a band to surround a limb of the patient, the needle aligner can be stabilised on the surface of a limb of a patient, allowing the imaging probe to be held in a way which maintains an image of the blood vessel into which the needle is to be inserted.

[0043] In some embodiments, the at least one stabiliser flap is shaped to include a recess so as to allow needle insertion into the imaging plane of the probe. This allows theneedle guide to be used for both in-plane and out-of-plane needle guidance, thereby increasing the clinical utility of the needle guide.

[0044] In some embodiments, the housing comprises a base portion and sidewalls connected to the base portion, wherein the sidewalls are symmetrically aligned and diametrically opposed either side of the needle guide part, wherein the sidewalls taper to reduce the radial separation of the walls perpendicular to the imaging plane of the probe toward the point of connection between the sidewalls and the base portion.

[0045] The taper of the sidewalls ensures that probes of differing lateral extent perpendicular to imaging plane are centred within the housing and therefore aligned with the needle guide part. This increases the universality of the needle guide in that it allows probes of different sizes to be used.

[0046] In some embodiments, the sidewalls each comprise an upper section, and wherein the upper section of each sidewall is oriented towards the opposing upper section. This arrangement of the sidewalls aids in securing the probe in use.

[0047] In some embodiments, the sidewalls each comprise a top portion, wherein the top portions curve outwardly to provide a surface which guides insertion of the probe into the probe holding portion.

[0048] In some embodiments, the needle guide includes a membrane positioned, in use, between the probe and the skin of the patient. The use of a membrane means that the probe does not contact the patient during use. Therefore, the probe is required to be fully sterilised less frequently.

[0049] In some embodiments, the membrane comprises an ultrasound conducting material to aid in the conduction of ultrasound waves from an ultrasound probe.

[0050] In some embodiments, the base portion comprises a patient-facing surface and wherein at least two diametrically opposed edges of the patient-facing surface are oriented towards each other. This advantageously aids in retaining ultrasound jellybetween the needle guide and the patient and, additionally, aids in retaining the needle guide in place when in use.

[0051] In some embodiments, the at least one stabiliser flap or the patient-facing surface of the base portion include a layer of adhesive applied thereon to aid in retaining the needle guide in place during use on a patient.

[0052] In some embodiments, the needle guide further comprises a resilient band, wherein the band is mounted on the housing and configured to resiliently deform to secure the probe when in use. The use of such a band improves the stability of the probe in use.

[0053] In some embodiments, the resilient band is mounted on the housing so as to provide a force on the probe with a component in the direction of the needle guide part and a component in the direction of the base portion.

[0054] In some embodiments, the needle guide part is connected to the housing so as to, in use, abut the skin of the patient. This allows the user to have greater control of the location of the tip of the needle, as most of the needle will be on user side of the pivot point of the needle guide part, rather than the patient side.

[0055] A further advantage of the needle guide part abutting the patient’s skin during use is that the skin holds the needle in the groove during use, thereby not requiring a further component to perform this function. Consequently, the complexity of manufacture of the design is reduced and ease of use of the needle aligner is increased.

[0056] In some embodiments, the housing comprises a slot and wherein the slot is oriented parallel with axis of the v-shaped groove and the imaging plane of the probe when in use. A slot provides a gap in the housing required for some types of imaging probe.

[0057] In some embodiments, the slot comprises tapered edges. Tapered edges on the slot aid in directing, for example, ultrasound jelly, into the housing when the needle aligner is moved during use across a patient’s skin.

[0058] In some embodiments, the groove is curved along its longitudinal axis parallel to the imaging plane of the probe. This allows the user to adjust the angle of the needle, in use, relative to the patient’s skin without moving the needle guide part whilst maintaining contact between the needle and the groove.

[0059] It will be appreciated that the needle aligner may, in an aspect of the invention, be integrated into the imaging probe itself. In this aspect of the invention there is provided a needle aligning probe comprising an imaging probe having a housing and a needle guide part which is attached to the housing and positionable relative thereto, the needle guide part comprising at least one needle guide configured to receive a needle and guide the needle along the guide so as to constrain the needle’s movement.

[0060] In various embodiments of this aspect of the invention, the needle guide part, and the means by which the needle guide part is attached to the housing, are as is described in respect of embodiments of the needle aligner. Further, in other embodiments of this aspect of the invention, the probe housing may comprise at least one stabiliser flap as described in respect of embodiments of the needle aligner.

[0061] An aspect of the invention provides a probe holder comprising gripping means configured to hold an imaging probe relative to an axis of rotation; and a rotation mechanism configured to rotate the gripping means around the axis of rotation.

[0062] In this way, the imaging probe can be held in a fixed position and rotated about a rotational axis which, in turn, can rotate the imaging plane from the imaging probe. For example, the imaging plane can be rotated from a view in which a blood vessel of a patient is imaged in a cross-section perpendicular to the axis of the blood vessel, to a view in which the blood vessel is imaged in cross-section parallel to the axis of the blood vessel. In use, the probe holder can be used to position the imaging probe to find the blood vessel in the cross-sectional view. The blood vessel can be centred within the image. Because the axis of rotation (which is aligned with the centre of the image) will now be aligned with the blood vessel. Rotating the probe using the rotation mechanism allows the long axis of the blood vessel is to be visualised, because the rotating theimaging plane around the axis of rotation, which is aligned with the blood vessel, will bring the long axis of the vessel into alignment with the imaging plane.

[0063] In some embodiments, the gripping means comprises a first and second clamp part, positionable relative to each other and disposed either side of the axis of rotation. In some embodiments, the gripping means is configured such that the first and second clamp part are biased toward each other.

[0064] Providing a gripping means mechanism in the form of a first and second clamp allows for the probe to be clasped and secured and within the gripping means such that different size imaging probes can be accommodated in the probe holder.

[0065] In some embodiments, the gripping means is configured such that the first and second clamp part move symmetrically about the axis of rotation, preferably wherein the gripping means comprises one or both of: a slider mechanism comprising a central slider connected to two pivoting slider arms of equal length respectively connected to each of the first and second clamp parts; and at least one linkage connecting each of the first and second clamp parts to the rotation mechanism.

[0066] By configuring the gripping means such that the clamp parts move symmetrically about the axis of rotation, is can be ensured that the imaging probe is secured such that the imaging plane (which generally corresponds to a central axis of the imaging probe) will be aligned with the axis about which the probe rotates.

[0067] In some embodiments, the rotation mechanism comprises a first component secured to the gripping means; a second component; and a bearing between the first and second component. In some embodiments, the rotation mechanism further comprises a means of adjusting a friction force between the first component and the second component, for example wherein the means of adjusting a friction force comprises a compression spring.

[0068] By providing a two components connected via a bearing, continuous rotational adjustment of the orientation of the imaging probe can be provided. Including a means for adjusting the friction force, such as a compression spring, allows for a degree ofresistance to rotation to be provided to mitigate against unintentional rotation of the imaging probe.

[0069] In some embodiments, the needle guide further comprises at least one needle guide configured to receive a needle and guide the needle along the guide so as to constrain the needle’s movement.

[0070] The needle guide may be configured such that the needles movement is constrained to a direction which intersects with the axis of rotation about which the gripping means rotates.

[0071] This way, when the probe holder is used in an ultrasound guided intravenous procedure, the imaging plane of the probe can be brought into alignment with the direction along which the needle will be guided.

[0072] In some embodiments, the probe holder comprises a needle guide part configured be attached to the probe holder and positionable relative thereto, the needle guide part comprising at least one needle guide configured to receive a needle and guide the needle along the guide so as to constrain the needle’s movement. In various embodiments, the needle guide part and the means by which the needle guide part is attached to the probe holder, are as is described in respect of embodiments of the needle aligner and the means by which it is attached to the housing of the needle aligner.

[0073] In some embodiments, the probe holder further comprises at least one finger loop, as described above in relation to the needle aligner.

[0074] An aspect of the invention provides a probe stabiliser system comprising a probe holder as discussed above; and means for positioning the probe holder relative to a part of a patient’s anatomy.

[0075] Such a probe stabiliser system can allow the probe to be positioned relative to part of a patient’s anatomy, with the probe then moved around an axis of rotation to facilitate an image-guided intravenous procedure.

[0076] In some embodiments, the means for positioning the probe holder comprises an arm connected at a first end to the probe holder, preferably wherein the arm is connected at its first end to the probe holder by a ball joint.

[0077] Disposing the probe holder on an arm can facilitate positioning of the probe holder across a range of positions, with a ball joint allowing for continuous adjustment of the pitch, yaw and roll of the probe holder.

[0078] In some embodiments the means for a positioning the probe holder further comprises a rail and brake system including at least one rail and respective brake which is movable on the rail, wherein the arm is connected at a second end to the rail system, preferably by a ball joint, and wherein the rail and brake system comprises one or both of a linear rail with a respective brake; and an arch rail with a respective brake.

[0079] The use of rail and brake systems allows for easy adjustment of the position of the probe holder across a variety of positions and, in turn, allows the probe to be easily positioned with respect to a particular part of a patient’s anatomy. For example, where the part of the patient's anatomy is a limb, a linear rail (with a respective brake) can facilitate positioning of the probe holder along the length of the limb whilst an arch rail (with respective brake) can facilitate positioning of the probe holder around the patient’s limb. For example, the brake of the linear rail may be constrained to run along the linear rail. The arch rail may be disposed on the brake of the linear rail such that the arch rail may be moved linearly. The brake of the arch rail may be constrained to run along the arch rail with the probe holder connected to the brake of the arch rail, for example by way of the arm.

[0080] In some embodiments, the part of the patient’s anatomy is a limb of the patient, the probe stabiliser system further comprising a base portion to which the means for positioning the probe is attached, the base portion comprising a limb rest.

[0081] By providing an arm rest on a base portion to which the means for positioning the probe is attached, the patient can rest their limb such that it sits in a particularposition, about which the probe holder can be positioned by way of the means for positioning the probe.

[0082] An aspect of the invention provides a probe holder comprising a housing configured to be secured to the housing and at least one finger loop.

[0083] In some embodiments the finger loop is connected to the housing by a pivotable connection.

[0084] The housing may be substantially as described above in relation to the needle aligner. The finger A ‘finger loop’ is to be understood to be a feature which is sized to receive one or more fingers of the user, thereby allowing them to stabilise the needle aligner without grasping it. The finger loop may be a fully closed loop or may be an open loop. Preferably, it is attached by way of a pivotable connection.

[0085] By way of the finger loop, the user is able to stabilise and position the probe relative to the patient’s skin without having to fully grasp the probe. In use, each finger loop allows for the probe to be suspended from one finger of the user. The user’s other fingers are free to manipulate one end of the probe, pivoting the probe to manipulate the probe to accurately tilt and position the probe. Compared to grasping the imaging probe with the whole hand, the use of a finger loop allows for very fine movements of the probe for precise alignment with the blood vessel within the patient.BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS

[0086] The present invention, both as to its organization and manner of operation, together with further objects and advantages, may best be understood by reference to the following description and the accompanying drawings. These and other details of the present invention will be described by reference to the accompanying drawings, which are furnished only by way of illustration and not in limitation of the invention, and in which drawings:

[0087] Figure 1 illustrates a perspective view of an ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0088] Figure 2 and 2A illustrate side views of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0089] Figure 2b illustrates a perspective view of an ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0090] Figures 3, 3 A and 3B illustrate a front view a rear view and a bottom view of the ultrasound probe stabilizer respectively in accordance with one embodiment of the present subject matter.

[0091] Figures 3C, 3D and 3E illustrate a perspective view, a top view and a rear view of the probe clamp assembly respectively in accordance with one embodiment of the present subject matter.

[0092] Figures 4 and 4A illustrate side views of probe clamp assembly of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0093] Figure 4B illustrates an exploded view of the probe clamp assembly of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0094] Figures 4C to 4F illustrate perspective views of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0095] Figure 5 illustrates a perspective view of probe clamp assembly of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0096] Figure 6 illustrates a cross sectional view of the probe clamp assembly of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0097] Figure 6A illustrates a perspective view of the linkage of the probe clamp assembly in accordance with one embodiment of the present subject matter.

[0098] Figure 7 illustrates a cross sectional view of the probe clamp assembly of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0099] Figure 8 illustrates a top view of the probe clamp assembly of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0100] Figure 9 illustrates a cross sectional view of the probe clamp assembly of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0101] Figures 10 and 10A illustrate a perspective view and a sectional view of the probe clamp assembly of the ultrasound probe stabilizer depicting a friction device for controlling the rotation of the probe clamp assembly in accordance with one embodiment of the present subject matter.

[0102] Figure 11 illustrates a sectional view of the probe clamp assembly of the ultrasound probe stabilizer depicting parts of the friction device in accordance with one embodiment of the present subject matter.

[0103] Figure 12 illustrates the magnified view of the friction device of the probe clamp assembly of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0104] Figure 13 illustrates the magnified view of the bottom part of the probe clamp assembly of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0105] Figure 14 illustrates a perspective view of a needle aligner in accordance with one embodiment of the present subject matter.

[0106] Figure 15 illustrates a perspective view of the needle aligner containing an ultrasonic probe in accordance with one embodiment of the present subject matter.

[0107] Figure 16 illustrates an exploded perspective view of the needle aligner in accordance with one embodiment of the present subject matter.

[0108] Figure 17 illustrates top down view of the needle aligner in accordance with one embodiment of the present subject matter.

[0109] Figure 18 illustrates a bottom up view of the needle aligner in accordance with one embodiment of the present subject matter.

[0110] Figure 19 illustrates a perspective view of a further needle aligner in accordance with one embodiment of the present subject matter.

[0111] Figure 20 illustrates a top down view of a further needle aligner in accordance with one embodiment of the present subject matter.

[0112] Figure 21 illustrates a side on view of the needle aligner in accordance with one embodiment of the present subject matter.

[0113] Figure 22 illustrates details of a needle guiding part of a needle aligner in accordance with one embodiment of the present subject matter.

[0114] Figure 23 illustrates a perspective view of the needle aligner containing an ultrasonic probe in accordance with one embodiment of the present subject matter.

[0115] Figure 24 illustrates a needle aligner in accordance with one embodiment of the present subject matter.

[0116] Figure 25 illustrates a perspective view of a needle aligner in accordance with one embodiment of the present subject matter.

[0117] Figure 26 illustrates a top perspective view of a needle aligner in accordance with one embodiment of the present subject-matter.

[0118] Figure 27 illustrates a bottom perspective view of the needle aligner of Figure 26.

[0119] Figure 28 illustrates a top view of the needle aligner of Figure 26.

[0120] Figure 29 illustrates a bottom view of the needle aligner of Figure 26.

[0121] Figure 30 illustrates a side view of the needle aligner of Figure 26.

[0122] Figure 31 illustrates another side view of the needle aligner of Figure 26.

[0123] Figure 32 illustrates a front view of the needle aligner of Figure 26.

[0124] Figure 33 illustrates a back view of the needle aligner of Figure 26.

[0125] Figure 34 illustrates a perspective view of an alternative needle guide part with a curved groove that may be used with the needle guide of Figures 26 to 33.

[0126] Figure 35 illustrates a side view of the needle guide part of Figure 34.DETAILED DESCRIPTION

[0127] The following presents a detailed description of various embodiments of the present subject matter with reference to the accompanying drawings.

[0128] The embodiments of the present subject matter are described in detail with reference to the accompanying drawings. However, the present subject matter is not limited to these embodiments which are only provided to explain more clearly the present subject matter to a person skilled in the art of the present disclosure. In the accompanying drawings, like reference numerals are used to indicate like components.

[0129] The specification may refer to “an”, “one”, “different” or “some” embodiment s) in several locations. This does not necessarily imply that each such reference is to the same embodiment s), or that the feature only applies to a single embodiment. Single features of different embodiments may also be combined to provide other embodiments.

[0130] As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless expressly stated otherwise. It will be further understood that the terms “includes”, “comprises”, “including” and / or “comprising” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. It will be understood that when an element is referred to as being “attached” or “connected” or “coupled” or “mounted” to another element, it can be directly attached or connected or coupled to the other element or intervening elements may be present. As used herein, the term “and / or” includes any and all combinations and arrangements of one or more of the associated listed items.

[0131] The figures depict a simplified structure only showing some elements and functional entities, all being logical units whose implementation may differ from what is shown.

[0132] The present invention relates to an ultrasound probe stabilizer which is useful for all ultrasound guided procedures such as intravenous cannulation; nerve blocks; biopsies; fluid drainage from the body such as from the abdomen, chest cavity for diagnostic / therapeutic treatment.

[0133] In an embodiment of the present invention the ultrasound probe stabilizer is configured to integrate a needle aligner, which aligns needle of any size for guided cannulation or any injecting procedures.

[0134] The ultrasound probe stabilizer and the needle aligner comprise a plurality of assemblies.

[0135] Figure 1 illustrates a perspective view of an ultrasound probe stabilizer 1000 in accordance with one embodiment of the present subject matter. The ultrasound probe stabilizer 1000 comprises a probe clamp assembly 100; a carriage assembly 300; a pair of ball joints 200; and one or more arm rests 400 and one or more counterweights 403. Figure 2 illustrates a side view of the ultrasound probe stabilizer in accordance with oneembodiment of the present subject matter. Figure 3 illustrates a front view of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter. Figure 4 illustrates a side view of probe clamp assembly of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter.

[0136] Various components, assemblies and sub-assemblies of the ultrasound probe stabilizer (UPS) that aid to perform ultrasound guided intravenous cannulation speedily and accurately are explained in the following paragraphs in detail:Probe clamp assembly 100

[0137] Figure 5 illustrates a perspective view of probe holder 100, also referred to as probe clamp assembly 100, of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter. The main function performed by the probe clamp assembly 100 is to be universal and hold any sized probe 105 in the center of a circular platform 104. The probe clamp assembly 100 comprises a gripping mechanism, also referred to has a clamping system, having two clamp parts or clips 102 that can be squeezed together to open the clamps 101 to insert the probe 105 in an embodiment. When released, one of the clamp closes under spring tension and exerts a significant force on the probe 105. This force and the resulting friction prevents the probe from moving unintentionally, which ensures its stability and centrality. The probe clamp assembly 100 maintains centrality of the probe while in operation.

[0138] Figure 6 and Figure 7 represent the cross-sectional views of the probe clamp assembly of the ultrasound probe stabilizer in accordance with one embodiment of the present subject matter. The clamping mechanism is shown in detail in Figure 6, which shows how the clamp maintains centrality. In an embodiment, the probe clamp assembly comprises four linkages 106, which connect the probe clamp assembly to the circular platform 104. These linkages 106 are set at a fixed vertical distance and are of the same length. When the linkages 106 pivot, they form a parallelogram shape that maintains the parallelism of the clamping contact face throughout the motion. This ensures that the probe 105 remains central when clamped.

[0139] Figure 7 illustrates a cross-sectional view of the probe clamp assembly 100, in which a central slider 107 is shown. The central slider 107 is an important component of the probe clamp assembly 100. The function of the central slider 107 is to ensure that both the clamps 101 move by the same amount whenever the central slider 107 moves. It is achieved by connecting the slider to both clamps using two slider arms 108 of equal length. These arms 108 are attached to the central slider 107 at fixed points and to the clamps 101 at pivot points. As a result, the central slider 107 and the slider arms 108 move together and causes both clamps 101 to move by the same distance. The mechanism also comprises a spring system that keeps the clamps 101 closed by default. The springs are connected through spring holes 109 in the linkages 106 and exert a downward force on them. This force pulls the clamps 101 together, creating a strong grip on the probe 105. To open the clamps 101, one has to squeeze them against the spring force and then release them when they are in the desired position. Therefore, this mechanism comprises two main sub-assemblies, i.e., the linkages 106 on either side of the clamps 101 for maintaining their parallelism, and the central slider 107 for maintaining their synchronization. Thus, the mechanism ensures that the clamps are always parallel and synchronized when opening or closing.

[0140] Figure 8 illustrates a top view of the probe clamp assembly 100 depicting a rotation mechanism in an embodiment. The rotation mechanism of the probe clamp assembly 100 allows the probe 105 to rotate around its central axis while remaining centralized. The rotation mechanism relies on a central slider 107 that connects both clamps 101 by using two slider arms 108 of equal length. These slider arms 108 are fixed to the slider 107 and pivot on the clamps 101. It ensures that both the clamps 101 move by the same distance when the central slider 107 moves and vice versa. The central slider 107 also comprises a compressible pad 110 in an embodiment that provides a cushion for the probe 105 and helps the probe stay in the center of the clamps 101.

[0141] The rotation mechanism also comprises a spring system that keeps the clamps closed by default. The springs are attached to one or more spring holes 109 in the linkages 106 and pull them downward. It creates a downward force on the clamps 101that grips the probe 105 firmly. To open the clamps 105, one has to squeeze them against the spring force and then release them when they are in the desired position.

[0142] Figure 9 illustrates a sectional view of the probe clamp assembly 100. The rotation mechanism also comprises a top component 111 and a bottom component 112. The top component 111 of the rotation mechanism is connected to the probe clamps 101, and the bottom component 112 is connected to the probe cap 103. In an embodiment, the bottom component 112 comprises three parts that form a custom-made bearing assembly. The bearing assembly is mounted on the outer race of the bearing assembly and connected to the rest of the structure. The bearing assembly allows the top component 111 to rotate smoothly with the probe 105 while keeping it centralized. The rotation mechanism also comprises a friction mechanism 113 that limits the rotation of the probe.

[0143] Figure 10 illustrates the friction mechanism 113 under its cover 114. The friction mechanism 113 comprises an arm that pivots around a pin (not shown in figures) and contacts the edge of the top component 111. This contact creates friction, preventing the probe 105 from spinning too fast or easily. The friction mechanism 113 enables the user to rotate the probe 105 to a desired position and leave it there without worrying about it moving. The friction force is determined by a spring that is located in a cavity.

[0144] Figure 11 illustrates a perspective view of the probe clamp assembly, in which the cavity 115 is shown where a spring for engaging the friction device to the top component I l l is located. In an embodiment, the spring comprises a compression spring that determines the friction force between an arm and the top component. The arm pivots around a pin and contacts the edge of the top component 111. Figure 11 shows the arm and the contact point. The friction force prevents the probe from spinning too fast or too easily. A user can adjust the friction force by turning a thread screw 116 that moves a white cup 117 back and forth. The cup 117 compresses or decompresses the spring in its cavity.

[0145] Figure 12 illustrates the magnified view of the cavity 115 of the thread screw 116 and the cup 117 in an embodiment. The rotation mechanism allows for a wide range of motion for the probe.Probe Clamp Cover 103

[0146] The probe clamp cover 103 is configured to be removable and comprises a plurality of clips for clamp cover 103 on both sides. In an embodiment, the clips lock the clamp cover 103 by snap fit arrangement. As can be seen in Figure 13, when the cover is inserted into the probe cap, the plastic parts flex and pivot outward until they snap into place. It allows easy removal and cleaning or replacement of the cover without contaminating the rest of the probe clamp. The probe clamp must be kept clean as it comes into contact with the patient and requires a gel to enable the sonic beam to travel from the probe to the patient. The gel fills the gap between the probe and the patient.Ball Joints 200

[0147] The ultrasound probe stabilizer also comprises two ball joints 200 on each side of an arm. In an embodiment, one ball joint is provided at the point of attachment of the arm with the probe clamp assembly 100 and another ball joint is provided at the point of attachment of the arm with the carriage assembly 300. In an embodiment, both the ball joints 200 are similar, except for the difference in resistance. The ball joints provide many degrees of freedom, which ensures easy movement of the probe clamp assembly 100 in any direction and benefits the ’performance of the clamps. The ball joints ensure that the probe clamp assembly 100 can move and rotate within that circular face. The probe clamp assembly 100 can also change its orientation, i.e., it can be parallel, perpendicular, or tilted to the face. The ball joint assemblies give the probe clamp assembly 100 much more freedom than other types of joints. In the present embodiment, the two ball joints 200 provide phenomenal flexibility and allow movement outside the plane due to their circular faces. For instance, they can move from one position to another. In an embodiment, each ball joint 200 comprises a plurality of components comprising but not limited to a base 202 having a male thread, a cup for holding a spherical ball and connects to the threaded base and a spring in the center for exerting a force on a component that presses against the bottom of the ball. Friction is created between the ball and the cup surfaces of the ball joint that is crucial for stabilizing the mechanism and supporting weight, especially for a probe. The friction can be adjusted by rotating a textured surfaceon the outside of the cup downward, which compresses the spring more and increases resistance, this enables control over how stiff or smooth the mechanism functions.Rail Brakes and Rails

[0148] The ultrasound probe stabilizer also comprises an arch rail 302. The carriage assembly 300 controls the movement of the arm and the probe clamp assembly 101 around the central axis of the arch rail 302. The arch rail 302 comprises an archway 305 for movement of the carriage assembly 300.

[0149] The carriage assembly 300 can move along the arch rail 302 smoothly. In an embodiment, the carriage assembly 300 comprises two stationary wheels (not shown in the drawings) ride in a cavity (archway 305) at the inner side of the rail. Both wheels fit snugly in the cavity. In an embodiment, a third wheel is also provided in the carriage assembly 300 that moves on the outer surface or cavity of the arch rail 302. In an embodiment, the third wheel is configured to be adjusted or moved. The adjustment of the third wheel can be accomplished by removing a back cover of the carriage assembly 300 and revealing a central piece (not shown in drawings) in an embodiment. In the present embodiment, the center piece is attached to the third wheel at the top of the cavity by a screw. The center piece can slide up and down along the screw, which threads into the bottom part. Doing so exerts a downward force on the top wheel, which presses against the cavity, thereby creating friction and stability for the assembly. The screw can be tightened or loosened to adjust the movement. The screw moves down without affecting this piece, which can slide freely along the screw. A spring is provided that wraps around the screw and pushes down and up on this face. Tightening the screw compresses the spring and pushes this component and the wheel down further. This creates more pressure on the wheel, which tightens the connection between the carriage and the rail, in an embodiment, two more mechanisms provided are provided on either side of this box in the carriage assembly, i.e., a resistance mechanism for controlling movement of the carriage assembly and a brake mechanism for holding the carriage assembly in a position on the arch rail. In an embodiment, the brake mechanism comprises two black fins that can be pinched together. At the time of pinch, they pivot at the bottom and move a rubbernub away from the side of the rail. The rubber nub acts as a brake when it presses against the rail, creating high friction and stopping the movement. The brake is released by a spring that sits in this cavity and pushes the two fins apart. The spring constantly tries to force the brake open. The brake mechanism can be optionally disabled by screwing in the thumb screw. It pushes the lever forward and releases the brake.

[0150] In an embodiment, the resistance mechanism is similar to the brake mechanism and is always active. In an embodiment, the resistance mechanism comprises a cup with a spring inside it that pushes the arm outward. The spring force can be adjusted by screwing in or out of this screw, which changes the compression of the spring in an embodiment. This mechanism creates less friction than the brake but enough to keep the carriage from sliding freely. The resistance mechanism and the brake mechanism can be used together or separately.

[0151] In another embodiment of the present invention, the resistance mechanism can be removed or swapped depending on the preference and the position of the device. In addition to these brakes 301 for the archway, there are also linear brakes 303 for linear rails 304 at the bottom of the ultrasound probe stabilizer. The linear rails 304 are configured to slide the ultrasound probe stabilizer back and forth, allowing to position the probe 105 anywhere along a person's arm. In an embodiment, the linear rails have a range of motion of about 300 millimeters. The linear rails ensure smooth sliding and can be fixed once a desired position is achieved. In an embodiment, two mechanisms, i.e., a resistance mechanism and a brake mechanism are provided at the linear rails for controlling the linear motion of the ultrasound probe stabilizer along the length of the linear rails. Depending on the size of a person's arm, the height of the archway 305 can be changed to align it with the axis of the arm of person. The archway can be raised or lowered and knobs 306 may be used to tighten it and clamp it in place.Arm Rest and weights

[0152] Figure 1 and Figure 2 depict two arm rests 400 and a counterweight 403 in an embodiment. Having the arm / forearm adequately exposed and stabilized is an important part of intravenous cannulation IVC. Two armrests 400 support the arm and forearm ofthe patient adding better stability while placing an IVC. An arm of any size can be fit into the armrests 400. The arm mounted on the stands 401 to align them with the center of the archway.

[0153] A plurality of connecting plates is provided at the top and bottom of the device. These plates allow the device to be manufactured using smaller pieces and transported more easily. They also have cavities 402 for counterweights 403. In an embodiment, a large and heavy steel plate can be inserted in these cavities 402 to make the device more stable and prevent it from wobbling when its parts are moved.Needle aligner 700

[0154] Figure 14 shows a needle aligner 700. The needle aligner comprises a housing 710 and a needle guide part 750. In this embodiment the needle guide part 750 is in the form of a base plate (or, equivalently, a bottom plate) attached to the housing 710. The housing is in the form of a clasp made up of two clamping members 711 and 712 configured to secure the probe therebetween. Figure 15 illustrates the needle aligner in use with an ultrasonic probe 105 to which the needle aligner has been secured.

[0155] The bottom plate is connected to the claspable parts and features a central slit, which aligns with the ultrasound beam. The size of the slit corresponds to that of an intravenous cannula or needle, ensuring proper accommodation. The plate is adjustable in small increments from side to side, allowing for precise tuning of the ultrasound beam to be directly under the metallic needle.

[0156] The triangular housing is located at one end of the bottom plate and serves to restrict the direction of the needle. By confining the needle's movement to be solely under the ultrasound beam, the device ensures continuous and optimal visualization throughout the procedure.

[0157] At the opposite end of the bottom plate, a prefixed metallic needle is securely attached. This needle provides a reference point and assists in aligning the ultrasound beam precisely with the intended needle insertion site.

[0158] Additionally, the bottom plate of the device can be covered by a thin plastic film, which acts as a sterile barrier. This protective film prevents direct contact between the ultrasound probe and the patient's skin, maintaining a sterile environment throughout the procedure. Furthermore, the bottom plate's design enhances stability, creating a more secure interface between the probe and the patient's skin.

[0159] Figure 16 shows an exploded perspective view of the needle aligner 700. This shows the housing 710 in its component parts, first clamp part 711 and second clamp part 712. Screws 720, 721 can be used to bring the clamp members together and thereby secure the probe 105. The housing 710 includes a groove 715 on each side. The base plate 750 includes ridges 751 which are captured by the groove, such that the base plate is slidable relative to the housing 710.

[0160] Figures 17 and 18 show a top down and bottom up view, respectively, of the needle aligner 700. As can be seen in Figure 17 the base plate 750 includes a channel 7551 which captures a pin 765 disposed on an adjustment screw 760. The adjustment screw can be used to move the pin along the length of the channel. Because the movement of the base plate 750 is constrained by the grooves 715 and ridges 751, the base plate will be moved along one axis to allow the needle channel to be brought into alignment with the imaging plane of the probe 105.

[0161] Figure 19 shows a further embodiment in which the needle aligner 700 further comprises finger loops 780. In this example, the finger loops 780 are disposed on the base plate. The finger loops are secured to the base plate by a rotatably connection 785 (as indicated by the curved arrow). These finger loops allow the use to hold the needle aligner (and thereby hold the probe) by inserting their fingers into one or both of the loops, allowing the user to securely hold the probe 105 in place without grasping it. The probe will be suspended from the one or two of the user’s fingers leaving the user’s other fingers free to manipulate the end of the probe to pivot and tip the probe, allowing for very fine control of the ultrasound imaging probe, particularly when compared to the level of control possible when the probe is grasped in the whole hand of the user.

[0162] In embodiments of the present invention (not illustrated) a finger loop is provided on the probe holder 100 described above. In those embodiments, the user is able, by way of their free fingers, to pivot and tip the probe, and also to rotate the probe around its central axis by way of the rotation means.

[0163] A further example of the needle aligner 700 is illustrated in Figure 20. Here the first and second clamp parts 711, 712 are secured together by a biasing means (such as a spring, not illustrated) such that the clamp parts are biased toward a closed position to secure a probe therebetween. In this example the needle guide part 750 is disposed on a support 730 which is part of the housing 710, captured between the two clamp parts 711,712. The needle guide part 750 is slidable along the support 730 such that it can be positioned to align with the imaging plane of the probe. The angle of the needle guide part 750 can be adjusted by rotating it on the support 730. The needle guide part 750 includes a v-shaped groove 755 which can accommodate needles of different sizes.

[0164] This example further includes stabilising flaps 740 as part of the housing 710. These stabilising flaps 740 extend away from the housing and provide a surface to stabilise the probe 105 against the skin of the patient as the probe 105 is being positioned. The underside surface of the flaps 740 (i.e. the surface which in use faces the patient’s skin) is curved so as to better conform to the surface of the patient’s limb, improving the stability provided by the stabilising flaps 740. A functional advantage of having the needle aligner secured against the patient, in use, at least in part by stabilization flaps extending away (i.e., in a plane that is not parallel to the imaging plane) from the imaging plane of the probe is that it prevents tilting, keeping the probe and imaging beam of the probe perpendicular, or approximately perpendicular, to the skin of the patient upon which it abuts in use. A tilted probe can misalign the imaging beam, leading to an improper procedure in use.

[0165] Figures 23 and 24 illustrate the needle aligner of this example in use, with Figure 23 showing a probe 105 inserted into the needle aligner, and Figure 24 showing the needle aligner being used to stabilise the probe in place on a patient’s limb.

[0166] Figure 25 shows a further embodiment of the needle aligner which comprises two needle guiding parts 750 arranged on perpendicular sides of the needle aligner. The housing is secured to the probe by way of securing screw 770. Stabilising flaps 740 extend away from the housing disposed either side of the housing 710. As shown, two stabilising flaps 740 extend away from one side of the housing 710, disposed either side of the needle guiding part 750 connected to that side of the housing 710.

[0167] In other embodiments (not illustrated) the stabilising flaps can be provided in the form of a band which surrounds the patient’s limb. The band may be elastic, or may be adjustable, so as to hold the needle aligner in place on the patient’s limb.

[0168] A further embodiment of the needle aligner 800 is shown in Figures 26 to 33. This embodiment comprises a housing 710, wherein the housing includes a probe housing portion 805 configured to house probe 105 during use. The probe housing portion 805 comprises a clasp portion in the form of vertically extending sidewalls 810, rear portion 850, and a front or beak portion 830 located adjacent to the needle guide part 750. The housing also includes a stabiliser flap in the form of base portion 820 connected to the probe housing portion 805, configured to abut against the patient’s skin during use. Base portion supports 825 are included to increase the strength and stability of the connection between the probe housing portion 805 and the base portion 820.

[0169] The base portion 820 comprises a rectangular slot 860, which is centred along the length axis of the housing. The slot is arranged to be aligned with the imaging plane of the probe so as to provide a gap in the housing through which imaging can occur when in use. Furthermore, the axis of the v-shaped groove 755 of the needle guide part 750 is parallel to the length axis of the slot 860.

[0170] The base portion 820 can be manufactured as a single, continuous plate, thereby providing stability and a secure foundation for the device. Alternatively, the base portion 820 can comprise a cut-out or recess to allow a needle to be inserted into the imaging plane of the probe, rather than through the imaging plane of the probe as provided by the needle guide part 750.

[0171] As best seen in Figs. 32 and 33, the base portion 820 is slightly curved about the needle guide part 750, which aids in retaining, for example, ultrasound jelly between the skin of the patient and the base portion when in use, preventing leakage. Furthermore, this arrangement also aids in maintaining contact between the needle aligner 800 and the patient as it is moved.

[0172] The vertically extending sidewalls 810 are symmetrically arranged and diametrically opposed either side of the slot 860, such that the vertically extending sidewalls 810 are symmetrically arranged and diametrically opposed either side of the imagine plane of the probe when in use. The vertically extending sidewalls 810 each comprise a tapered section, wherein the radial separation of the walls perpendicular to the imaging plane of the probe reduces toward the point of connection between the sidewalls 810 and the base portion 820 in the tapered sections 815. This arrangement allows probes 105 of a range of different sizes (i.e., differing extents in the axis perpendicular to the imaging plane of the probe) to be centred within the probe housing portion and therefore aligned with the slot 860.

[0173] The vertically extending sidewalls 810 have a degree of resilient flexibility such that they can bend outwards to accommodate the probe 105. This also aids in retaining the probe 105 as the resilient deformation of the sidewalls 810 causes an opposing retaining force to be applied to be probe 105. Moreover, as best shown in Figure 32, the sidewalls each comprise an upper portion 817, wherein the upper portion 817 is oriented towards the opposing upper portion 817 of the other sidewall 810. This aids in retaining the probe 105 when in use. The vertically extending sidewalls include top portions 813, wherein the top portions 813 curve outwardly to provide a surface which guides insertion of the probe into the probe holding portion 805.

[0174] Slot 860 may comprise tapered edges 865, as best seen in Figure 28. The tapered edges act akin to a razor, such that, for example, ultrasound jelly held between the base portion 820 and the patient’s skin, in use, is moved into the housing as the needle aligner is moved across that patient’s skin via the action of the tapered edges.

[0175] Needle guide part 750 is disposed on support 730. Support 730 can freely rotate within support connections 823 on the housing 710. Support 730 may comprise a first 867 and a second axle 869 diametrically opposed either side of the v-shaped groove 755, wherein the first 867 and second axles 869 are fixedly coupled to the needle guide part 750 and rotatably coupled to the housing via support connection 823.

[0176] As best seen in Figures 27 and 29, first and second axles 867 and 869 may define a linear axis, and the linear axis perpendicularly intersects the axis of v-shaped groove. As the needle guide part 750 rotates about the linear axis of the axles, this means that when in use (with a needle situated in the groove), when the user wishes to rotate the angle of the needle, rotation of the needle guide part 750 exactly corresponds to a rotation of the needle as the axis about which the needle aligner pivots intersects the needle in use.

[0177] The needle guide part 750 may be connected to the housing so as to contact the patient’s skin during use. In this way, axis about which the needle guide part 750 pivots, defined in the illustrated example by the first and second axles 867 and 869, is in close proximity to the patient’s skin during use. This allows the user to have greater control of the location of the tip of the needle, as most of the needle will be on user side of the pivot point, rather than the patient side. Accordingly, when altering the angle of the needle, the patient side of the needle comprising the tip traces a small arc, whereas the user side of the needle traces a large arc due the majority of the length of the needle being located on the user side of the pivot.

[0178] The needle aligner may be used in conjunction with a resilient band 900. The resilient band 900 may be mounted to the onto the probe housing portion 805 via sidewall hooks 890, comprised on the sidewalls 810 and frontal hook 895 comprised on the front portion 830 of the probe holding portion of the housing. The resilient band is moveable to secure the probe when in use, by resiliently deforming such that a restoring force is applied to the probe 105. This force has a component in the direction of the base 820 and a component in the direction of the front portion 830. The use of the resilient band therefore increases the stability of the probe 105 during use.

[0179] Needle aligner 800 may be used in conjunction with a membrane 1000, wherein the membrane is either affixed to the patient-facing surface of the base portion 820 and entirely covering the slot 860, or in between the probe and the housing, again entirely covering the slot 860. In this manner, the membrane provides a sterile barrier between the probe 105 and the patient, such that the probe does not require full sterilisation after each use. If the probe 105 is an ultrasound probe, the membrane may comprise an ultrasound conducting material.

[0180] In use, the base portion 820 or stabilisation flaps 740 may have a layer of adhesive applied thereon to reduce movement of the needle aligner and therefore increase stability of the probe and needle when in use.

[0181] Figures 34 and 35 illustrate an alternative needle guide part 752 which may be used with needle aligners 700 and 800, comprising a curved groove 756. The curvature is along the longitudinal axis of the groove, which is oriented to be parallel to the imaging plane of the probe when the probe 105 is seated in the housing. This arrangement allows the user to adjust the angle of the needle without moving the needle guide part 752, whilst maintaining contact between the needle and the needle guide part 752. In this way, fine angle adjustments can be made without moving the needle aligner part and larger adjustments of the needle angle can be made by moving the needle guide part.

[0182] Further, in any embodiment of the needle aligner, the needle guide part provide a plurality of different needle guides (which may each be v-shaped grooves) each generally sized to accommodate different sized needles. These might be disposed on the needle guide part in parallel, such that the desired needle guide can be positioned in the imaging plane of the probe 105. Alternatively, the different needle guides might be disposed on a rotatable wheel, which can be rotated to bring the desired needle guide into alignment with the imaging plane of the probe 105.

[0183] Further, in any embodiment of the needle aligner, the needle guide may be in the form of a needle clasp mechanism, having a first and second needle clamp. The needle clasp mechanism allows for the needle to be clasped and secured relative to the housing, such that it can be centred relative to the housing. This way, different sizeimaging probes can be accommodated in the needle aligner, and secured in the housing such that the imaging plane (which generally corresponds to a central axis of the imaging probe) will be aligned in roughly the same position within the housing. In turn, the adjustment to the position of the needle guide part relative to the housing can be kept to a minimum.

[0184] While the preferred embodiments of the present invention have been described hereinabove, it should be understood that various changes, adaptations, and modifications may be made therein without departing from the spirit of the invention and the scope of the appended claims. It will be obvious to a person skilled in the art that the present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive.EMBODIMENTSThe following is a list of embodiments which may or may not be claimed.1. A needle aligner for aligning a needle with the imaging plane of an imaging probe, comprising: a housing configured to be secured to the probe; and needle guide part which is attached to the housing and positionable relative thereto, the needle guide part comprising at least one needle guide configured to receive a needle and guide the needle along the guide so as to constrain the needle’s movement.2. The needle aligner of embodiment 1, wherein the at least one needle guide comprises a groove.3. The needle aligner of embodiment 2, wherein the groove is a v-shaped groove.4. The needle aligner of embodiment 3, wherein the v-shaped groove is wider at the side which in use will face a patient’s skin, and narrow at the opposing side of the groove.5. The needle aligner of any one of embodiments 1 to 4 , wherein the housing comprises a support, and the needle guide part is disposed on the support and wherein the support is configured to permit movement of the needle guide part along the axis of the support such that the needle guide can be brought into alignment with the imaging plane of the probe.6. The needle aligner of embodiment 5, wherein the needle guide part is slidable along the support .7. The needle aligner of embodiments 5 or 6, wherein the needle guide part is configured to rotate about the support.8. The needle aligner of embodiment 5, when dependent upon embodiment 4 being dependent on embodiment 2 or 3, wherein the support comprises a first and a second axlediametrically opposed either side of the groove, wherein the first and second axles are fixedly coupled to the needle guide part and rotatably coupled to the housing.9. The needle aligner of any of embodiment 5, embodiment 7 when dependent on embodiment 5, or embodiment 8, wherein the linear axis defined by the support intersects the v-shaped groove.10. The needle aligner of any of embodiments 5 to 9, wherein the support interfaces the needle guide part at approximately the midpoint of the longitudinal axis of the needle guide part perpendicular to the axis of the support.11. The needle aligner of any of embodiments 1 to 6, wherein the needle guide part comprises a plurality of needle guides, respectively sized to receive different sized needles, preferably wherein the plurality of needle guides are disposed on a wheel which can be rotated.12. The needle aligner of any of embodiments 1 to 3, wherein the needle guide part is a base plate which is adjustably connected to the housing.13. The needle aligner of embodiment 12, wherein the base plate is slidably connected to the housing, preferably by means of a projection on one of the base plate and the housing which is constrained in a groove in the other one of the base plate and the housing.14. The needle aligner of embodiment 12 or embodiment 13, wherein the position of the base plate relative to the housing can be adjusted by means of and incremental adjustment mechanism, such as an adjustment screw.15. The needle aligner of any of embodiments 1 to 14, wherein the housing comprises a clasp mechanism to secure the probe.16. The needle aligner of embodiment 15, wherein the clasp mechanism comprises one or more bands of elastic material configured to secure the probe in place relative to the housing.17. The needle aligner of embodiment 15, wherein the clasp mechanism comprises a first and second clamp part, positionable relative to each other, such that the imaging probe can be secured therebetween.18. The needle aligner of embodiment 17, wherein the first and second clamp part are biased toward each other to secure the imaging probe therebetween.19. The needle aligner of embodiment 17, comprising an adjustment means, preferably one or more adjustment screws, for moving the first and second clamp part toward each other to secure the imaging probe therebetween20. The needle aligner of embodiment 1, further comprising at least one finger loop.21. The needle aligner of any of embodiments 1 to 20, wherein the needle guide part comprises a needle blank, for example a length of metal with a similar thickness to the needle, the needle blank being held in a fixed position aligned to the axis of the needle guide.22. The needle aligner of any of embodiments 1 to 21, wherein the housing comprises at least one stabiliser flap extending away from the centre of the housing and providing an extended surface configured to, in use, abut the skin of the patient.23. The needle aligner of embodiment 22, wherein the extended surface has a curved configuration to provide a stable interface with the limb of a patient.24. The needle aligner of embodiment 22, wherein the at least one stabiliser flap is a band configured to surround a limb of the patient.25. The needle aligner of embodiments 21 to 24, wherein the at least one stabiliser flap is shaped to include a recess so as to allow needle insertion into the imaging plane of the probe.26. The needle aligner of any one of embodiments 1 to 10, wherein the housing comprises a base portion and sidewalls connected to the base portion, wherein the sidewalls are symmetrically aligned and diametrically opposed either side of the needleguide part, wherein the sidewalls taper to reduce the radial separation of the walls perpendicular to the imaging plane of the probe toward the point of connection between the sidewalls and the base portion.27. The needle aligner of embodiment 26, wherein the sidewalls each comprise an upper section, and wherein the upper section of each sidewall is oriented towards the opposing upper section.28. The needle aligner of either of embodiments 26 or 27, wherein the sidewalls each comprise a top portion, wherein the top portions curve outwardly to provide a surface which guides insertion of the probe into the probe holding portion.29. The needle aligner of any of embodiments 1 to 28, further comprising a membrane positioned, in use, between the probe and the skin of the patient.30. The needle aligner of embodiment 29, wherein the membrane comprises an ultrasound conducting material.31. The needle aligner of any of embodiments 1 to 30, wherein the base portion comprises a patient-facing surface and wherein at least two diametrically opposed edges of the patient-facing surface are oriented towards each other.32. The needle aligner of any of embodiments 22 to 31, wherein the at least one stabiliser flap or the patient-facing surface of the base portion include a layer of adhesive applied thereon.33. The needle aligner of any of embodiments 1 to 32, further comprising a resilient band, wherein the band is mounted on the housing and configured to resiliently deform to secure the probe when in use.34. The needle aligner of embodiment 33, wherein the resilient band is mounted on the housing so as to provide a force on the probe with a component in the direction of the needle guide part and a component in the direction of the base portion.35. The needle aligner of any of embodiments 1 to 34, wherein the needle guide part is connected to the housing so as to, in use, abut the skin of the patient.36. The needle aligner of any of embodiments 2 to 35, wherein the housing comprises a slot and wherein the slot is oriented parallel with axis of the groove and the imaging plane of the probe when in use.37. The needle aligner of embodiment 36, wherein the slot comprises tapered edges.38. The needle aligner of embodiments 2 to 37, wherein the groove is curved along its longitudinal axis parallel to the imaging plane of the probe.39. A probe holder comprising: gripping means configured to hold an imaging probe relative to an axis of rotation; and a rotation mechanism configured to rotate the gripping means around the axis of rotation.40. The probe holder of embodiment 39, wherein the gripping means comprises a first and second clamp part, positionable relative to each other and disposed either side of the axis of rotation.41. The probe holder of embodiment 40, wherein the gripping means is configured such that the first and second clamp part are biased toward each other.42. The probe holder of embodiment 40 or embodiment 41, wherein the gripping means is configured such that the first and second clamp part move symmetrically about the axis of rotation, preferably wherein the gripping means comprises one or both of: a slider mechanism comprising a central slider connected to two pivoting slider arms of equal length respectively connected to each of the first and second clamp parts; and at least one linkage connecting each of the first and second clamp parts to the rotation mechanism.43. The probe holder of any of embodiments 39 to 42 wherein the rotation mechanism comprises: a first component secured to the gripping means; a second component; and a bearing between the first and second component.44. The probe holder of embodiment 43, wherein the rotation mechanism further comprises a means of adjusting a friction force between the first component and the second component, for example wherein the means of adjusting a friction force comprises a compression spring.45. The probe holder of any of embodiments 39 to 44, further comprising at least one needle guide configured to receive a needle and guide the needle along the guide so as to constrain the needle’s movement.46. A probe stabiliser system comprising: the probe holder of any one of embodiments 39 to 45; and means for positioning the probe holder relative to a part of a patient’s anatomy.47. The probe stabiliser system of embodiment 46, wherein the means for positioning the probe holder comprises an arm connected at a first end to the probe holder, preferably wherein the arm is connected at its first end to the probe holder by a ball joint.48. The probe stabiliser system of embodiment 47, wherein the means for a positioning the probe holder further comprises a rail and brake system including at least one rail and respective brake which is movable on the rail, wherein the arm is connected at a second end to the rail system, preferably by a ball joint, and wherein the rail and brake system comprises one or both of: a linear rail with a respective brake; and an arch rail with a respective brake.49. The probe stabiliser system of any of embodiments 46 to 48, wherein the part of the patient’s anatomy is a limb of the patient, the probe stabiliser system furthercomprising a base portion to which the means for positioning the probe is attached, the base portion comprising a limb rest.

Claims

CLAIMS1. A needle aligner for aligning a needle with the imaging plane of an imaging probe, comprising: a housing configured to be secured to the probe; and needle guide part which is attached to the housing and positionable relative thereto, the needle guide part comprising at least one needle guide configured to receive a needle and guide the needle along the guide so as to constrain the needle’s movement.

2. The needle aligner of Claim 1, wherein the at least one needle guide comprises a groove.

3. The needle aligner of Claim 2, wherein the groove is a v-shaped groove.

4. The needle aligner of Claim 3, wherein the v-shaped groove is wider at the side which in use will face a patient’s skin, and narrow at the opposing side of the groove.

5. The needle aligner of any one of Claims 1 to 4 , wherein the housing comprises a support, and the needle guide part is disposed on the support and wherein the support is configured to permit movement of the needle guide part along the axis of the support such that the needle guide can be brought into alignment with the imaging plane of the probe.

6. The needle aligner of Claim 5, wherein the needle guide part is slidable along the support .

7. The needle aligner of Claims 5 or 6, wherein the needle guide part is configured to rotate about the support.

8. The needle aligner of Claim 5, when dependent upon Claim 4 being dependent on Claims 2 or 3, wherein the support comprises a first and a second axle diametrically opposed either side of the groove, wherein the first and second axles are fixedly coupled to the needle guide part and rotatably coupled to the housing.

9. The needle aligner of any of Claim 5, Claim 7 when dependent on Claim 5, or Claim 8, wherein the linear axis defined by the support intersects the v-shaped groove.

10. The needle aligner of any of Claims 5 to 9, wherein the support interfaces the needle guide part at approximately the midpoint of the longitudinal axis of the needle guide part perpendicular to the axis of the support.

11. The needle aligner of any of Claims 1 to 10, wherein the needle guide part comprises a needle blank, for example a length of metal with a similar thickness to the needle, the needle blank being held in a fixed position aligned to the axis of the needle guide.

12. The needle aligner of any of Claims 1 to 11, wherein the housing comprises at least one stabiliser flap extending away from the centre of the housing and providing an extended surface configured to, in use, abut the skin of the patient.

13. The needle aligner of Claim 12, wherein the extended surface has a curved configuration to provide a stable interface with the limb of a patient.

14. The needle aligner of Claim 12, wherein the at least one stabiliser flap is a band configured to surround a limb of the patient.

15. The needle aligner of Claims 12 to 14, wherein the at least one stabiliser flap is shaped to include a recess so as to allow needle insertion into the imaging plane of the probe.

16. The needle aligner of any one of Claims 1 to 10, wherein the housing comprises a base portion and sidewalls connected to the base portion, wherein the sidewalls are symmetrically aligned and diametrically opposed either side of the needle guide part, wherein the sidewalls taper to reduce the radial separation of the walls perpendicular to the imaging plane of the probe toward the point of connection between the sidewalls and the base portion.

17. The needle aligner of Claim 16, wherein the sidewalls each comprise an upper section, and wherein the upper section of each sidewall is oriented towards the opposing upper section.

18. The needle aligner of either of Claims 16 or 17, wherein the sidewalls each comprise a top portion, wherein the top portions curve outwardly to provide a surface which guides insertion of the probe into the probe holding portion.

19. The needle aligner of any of Claims 1 to 18, further comprising a membrane positioned, in use, between the probe and the skin of the patient.

20. The needle aligner of Claim 19, wherein the membrane comprises an ultrasound conducting material.

21. The needle aligner of any of Claims 1 to 20, wherein the base portion comprises a patient-facing surface and wherein at least two diametrically opposed edges of the patient-facing surface are oriented towards each other.

22. The needle aligner of any of Claims 12 to 21, wherein the at least one stabiliser flap or the patient-facing surface of the base portion include a layer of adhesive applied thereon.

23. The needle aligner of any of Claims 1 to 22, further comprising a resilient band, wherein the band is mounted on the housing and configured to resiliently deform to secure the probe when in use.

24. The needle aligner of Claim 23, wherein the resilient band is mounted on the housing so as to provide a force on the probe with a component in the direction of the needle guide part and a component in the direction of the base portion.

25. The needle aligner of any of Claims 1 to 24, wherein the needle guide part is connected to the housing so as to, in use, abut the skin of the patient.

26. The needle aligner of any of Claims 2 to 25, wherein the housing comprises a slot and wherein the slot is oriented parallel with axis of the groove and the imaging plane of the probe when in use.

27. The needle aligner of Claim 26, wherein the slot comprises tapered edges.

28. The needle aligner of Claims 2 to 27, wherein the groove is curved along its longitudinal axis parallel to the imaging plane of the probe.

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