Ultrasound Probe Holding Assembly

Abstract

Systems and methods for hands-free operation of ultrasound probes. Pressure is maintained between the ultrasound probe and the subject without the need for externally applied force (e.g., without a hand, robotic arm, or other external force application). Flexible components are primarily utilized that conform to the contours of the body for reduced distortion compared to rigid components used in conventional systems. Some embodiments provide a handle for probe orientation adjustment that can be selectively removed during hands-free operation to reduce gravitational moments. Other offerings include an integrated marking assembly for tracking probe location, wireless information capabilities (e.g., RFID), and an integrated ECG patch.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This patent application claims the benefit of International Patent Application No. PCT / IB2022 / 058083, filed August 29, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE INVENTION This application is directed generally to ultrasound systems, and more particularly to ultrasound probe assemblies. [Background technology]

[0003] Ultrasound imaging finds many applications in modern medical procedures and treatments. A fundamental aspect of ultrasound imaging of internal regions of a human or animal subject is the application of an appropriate force at the contact interface between an associated ultrasound probe and the subject. Also, in the context of modern clinical settings such as operating rooms, "hands-free" application of ultrasound probes, in which the probe is held in the same geographic location and applies the same pressure as when using a hand, but without the need to perform these tasks manually, is generally preferred. Assemblies and techniques that improve manual emulation in hands-free applications for various applications would be welcome. Summary of the Invention [Means for solving the problem]

[0004] Various embodiments of the present disclosure enable clinicians to safely and effectively perform long-term, hands-free ultrasound imaging within a patient with an ultrasound probe mounted on any body part and with the patient in any position (e.g., lying down, sitting, standing). Systems and methods are disclosed for holding the ultrasound probe in a fixed position on the patient and for applying pressure between the ultrasound probe and a selected body part without the need for an externally applied force (e.g., without a hand, robotic arm, or other external force application). Geometries of system components that enhance these aspects are also disclosed.

[0005] The disclosed systems and techniques can be applied to any part of the body for diagnostic ultrasound imaging, ultrasound-based image guidance in surgical procedures, or ultrasound-based therapies such as high-intensity focused ultrasound (HIFU). Any of a variety of ultrasound imaging probes and modalities may be utilized, including, but not limited to, single-planar, matrix, convex, linear, or other probe types for Doppler, elastography, M-mode, and other imaging modes. In one embodiment, the system is applied to phased-array bi-planar B-mode ultrasound imaging for guidance in cardiac wireless ablation therapy.

[0006] Various embodiments of the present disclosure primarily utilize flexible components that conform to the contours of the body for reduced distortion compared to the rigid components of conventional systems. The disclosed systems securely mount the probe to the patient without the need for structures that create rigid pressure points near the contact interface and attendant distortion of the image area. The disclosed systems can operate without the need for elastic straps that would otherwise generate strong radial force vectors on the retainer assembly. Some embodiments of the present disclosure allow for probe retention forces to be independent of pressure generated at the contact interface, provide a handle for probe orientation adjustment that can be selectively removed during hands-free operation to reduce gravitational moment, route probe cables parallel to the contact interface, and / or provide an integrated marking assembly for motion tracking of the probe location.

[0007] Various embodiments of the present disclosure may include an ergonomic restraint arrangement that may provide a mechanical advantage for easy decoupling and recoupling of the probe from the anchor tether. Some embodiments advantageously provide a gimbal structure for full range adjustment of the probe's pitch angle at the contact interface. A novel probe suspension assembly eliminates the need for a gimbal structure to contact the patient during operation. Still other embodiments may effect pitch angle adjustment without the need for a gimbal structure.

[0008] Conventional systems that provide the ability to secure an ultrasound probe and track its movement often require multiple components. Such multiple-component probe assemblies can be difficult to use because the components must be aligned with one another and adjusted to scan the desired target area. Many conventional multiple-component probe systems require two-handed operator handling or the participation of more than one operator. Various embodiments of the disclosed system integrate the components to facilitate installation and adjustment of the components and hands-free operation.

[0009] "Hands-free" ultrasound imaging techniques that eliminate the need to handle an ultrasound probe during scanning are known in the art. See, for example, International Patent Application No. WO 2017 / 052363 to Tchang et al., U.S. Patent Application Publication No. 2020 / 0015780 to Geelen et al., and U.S. Patent Application Publication No. 2014 / 0107435 to Sharf et al. Such conventional hands-free systems share various limitations and drawbacks, including a hard or rigidly backed mounting interface with the patient that can cause patient discomfort when mounted for extended periods of time, can distort the subject's body silhouette in the presence of obese subjects, and can generate small high-pressure points on the skin. Other conventional systems and methods apply force to an ultrasound probe with an articulating mechanical or robotic arm, which occupies a significant footprint around the probe's contact interface. Such an increased footprint may limit the usefulness of the ultrasound system in applications where the probe's position needs to be tracked in space (e.g., using an optical camera), where medical staff need to perform activities in the immediate vicinity of the contact interface, and / or where therapy / imaging machinery is required to operate in the immediate vicinity of the contact interface.

[0010] The foregoing functional aspects of various embodiments of the present disclosure address limitations and shortcomings of conventional probe holder assemblies. The disclosed probe holder assemblies are highly suitable for use in non-invasive beam therapy systems such as, but not limited to, those disclosed in International Patent Application Nos. WO 2022 / 136925 to Camps et al. (owned by the owner of this patent application), WO 2021 / 094824 to Camps et al., and WO 2019 / 096943 to Garonna et al.

[0011] Structurally, various embodiments of the disclosed probe holder assembly incorporate a probe housing for accommodation of a probe, the probe housing including a proximal end and a distal end separated by a sidewall having an exterior surface. The anchor assembly includes a compliant cover portion defining an opening for passage of the distal end of the probe housing, the opening defining a positioning axis and being collinear therewith, an adhesive layer covering a distal surface of the compliant cover portion, and a plurality of ties coupled to the compliant cover portion and extending proximally therefrom. A probe suspension assembly for coupling to the probe housing and anchor assembly includes a locking ring having an inner surface defining a ring axis and collinear therewith and configured to engage an outer surface of the sidewall of the probe housing to secure the locking ring to the probe housing, and one or more clasps coupled to the locking ring for selectively gripping, applying tension to, and maintaining tension on a plurality of ties of the anchor assembly. The probe suspension assembly is separated from the compliant cover portion by the plurality of ties.

[0012] In some embodiments, the anchor assembly includes a plurality of tie anchors attached to the compliant cover portion, each of the plurality of tie anchors connected to a corresponding one of the plurality of ties. The inner surface of the locking ring and the outer surface of the probe housing may be configured to statically secure the locking ring to the probe housing by a frictional force. In some embodiments, the frictional force is of a magnitude that can be selectively overcome by hand by applying a torsion to the probe housing about the ring axis, for example, exceeding the range of 1 to 2.5 Newton-meters (inclusive). The probe housing may be configured to couple with a locking ring of a probe suspension assembly proximate the distal end of the probe housing. In some embodiments, one or more clasps are adjustable along the plurality of ties to define a pitch angle of the ring axis relative to the positioning axis.

[0013] In some embodiments, the inner surface of the locking ring and the outer surface of the probe housing define complementary profiles for capture of the probe housing within the probe suspension assembly. The complementary profiles of the outer surface of the sidewall of the probe housing and the inner surface of the locking ring of the probe suspension assembly may define an arcuate profile. The arcuate profile of the outer surface of the sidewall may be convex, and the arcuate profile of the inner surface of the locking ring may be concave. In some embodiments, the arcuate profiles define spherical sections. The arcuate profiles may cooperate to allow the probe housing to be oriented at a selected pitch angle relative to the ring axis.

[0014] In some embodiments, the probe is an ultrasound probe. The distal end of the probe housing may include an ultrasound lens for directing ultrasound waves emitted from the ultrasound probe. The probe housing may be injection molded. In some embodiments, the lens comprises a polyamide material. The probe housing may include a feedthrough for a wire of the probe. In some embodiments, the feedthrough is located proximate to the proximal end of the probe housing.

[0015] In some embodiments, the probe holder assembly includes an information tag coupled to the compliant cover portion. In some embodiments, an electrocardiogram (ECG) sensor is coupled to the compliant cover portion.

[0016] Various embodiments of the present disclosure include a probe holder assembly comprising a probe suspension assembly for coupling with a probe, the probe suspension assembly including a locking ring having an inner surface defining a ring axis and collinear therewith and configured to capture and secure the probe, and one or more clasps for selectively gripping a plurality of ties, the one or more clasps coupled to the locking ring. The one or more clasps may include an actuation mechanism having a lever that engages at least one of the plurality of ties, and the lever may be configured for selective disengagement from at least one of the plurality of ties. In some embodiments, the lever is pivotally mounted to the actuation mechanism.

[0017] In some embodiments, the probe suspension assembly includes a biasing element configured to hold the lever engaged with at least one of the plurality of ties.

[0018] The lever may include a nib that engages the serrated surface of at least one of the plurality of ties, hi some embodiments, the lever secures the serrated surface of at least one of the plurality of ties against a nib disposed on the actuation mechanism.

[0019] In some embodiments, the locking ring is continuous. In other embodiments, the locking ring is bifurcated to define a first locking ring segment and a second locking ring segment. The first locking ring segment and the second locking ring segment may be pivotally connected to one another. In some embodiments, the probe is rotatable within the locking ring when the probe suspension assembly is in the partially closed configuration, and the probe is maintained in a fixed angular relationship within the locking ring when the probe suspension assembly is in the fully closed configuration. The probe suspension assembly may include a catch extending from the first locking ring segment to the second locking ring segment to interlock the first locking ring segment and the second locking ring segment in the fully closed configuration and statically secure the probe suspension assembly to the probe. In some embodiments, the catch includes a finger loop for manual actuation. The catch may be pivotally mounted to the first locking ring segment and selectively attachable to the second locking ring segment. In some embodiments, the catch includes a notch and a protrusion.

[0020] In some embodiments, in the partially closed configuration, the notch engages a first alignment surface of the protrusion, defining a first maximum separation distance between a midpoint of the first locking ring segment and a midpoint of the second locking ring segment. In the fully closed configuration, the notch engages a second alignment surface of the protrusion, defining a second maximum separation distance between a midpoint of the first locking ring segment and a midpoint of the second locking ring segment. In some embodiments, the first maximum separation distance exceeds the second maximum separation distance. In the partially closed configuration, the probe may be captured by the locking ring and rotatable therein, and in the fully closed configuration, the probe may be captured by the locking ring and in a fixed angular relationship therewith.

[0021] In some embodiments, the probe is selectively coupled to the locking ring in a torsional locking arrangement. The torsional locking arrangement may include a locking pin that mates with a locking groove. In some embodiments, the probe is housed within a probe housing. The probe housing may include a locking pin and the locking ring may define a locking groove.

[0022] Various embodiments of the present disclosure include a probe holder assembly including an anchor assembly including: a compliant cover portion defining an aperture concentric with and defining a positioning axis; a plurality of tie anchors coupled to the compliant cover portion; and a plurality of ties extending proximally from the plurality of tie anchors, each ties being connected to a corresponding one of the plurality of tie anchors. The compliant cover may have a mesh-like configuration. The compliant cover may be one of a fabric material, a polymer material, and a rubber material. In some embodiments, the ties of the plurality of ties are cable ties. The plurality of tie anchors may extend proximally through the compliant cover portion. In some embodiments, the plurality of tie anchors are coupled to a distal surface of the compliant cover portion.

[0023] The probe holder assembly may include an adhesive layer covering a distal surface of the compliant cover portion. The adhesive layer may cover distally facing surfaces of the plurality of tie anchors. In some embodiments, the probe holder assembly includes a probe suspension assembly including one or more clasps coupled to the anchor assembly for selectively gripping, applying tension to, and maintaining tension on the plurality of ties of the anchor assembly. The one or more clasps each include an actuation mechanism, which may have a lever, that engages at least one of the plurality of ties, and the lever may be configured for selective engagement and disengagement from at least one of the plurality of ties to freely position the probe suspension assembly proximally and distally along the positioning axis.

[0024] In some embodiments, the probe suspension assembly includes a locking ring for coupling to the probe, and one or more clasps are coupled to the locking ring. The probe holder assembly may comprise a marker assembly including a body portion defining a body axis extending through a proximal end and a distal end, the distal end of the body portion being mounted to the proximal end of the probe housing, and a plurality of markers coupled to the body portion, the markers configured for viewing with a camera.

[0025] Various embodiments of the present disclosure include a probe holder assembly comprising: a probe housing for containing a probe, the probe housing including a proximal end and a distal end separated by a sidewall having an exterior surface; and a marker assembly. The marker assembly may include a body portion defining a body axis extending through the proximal and distal ends, the distal end of the body portion being mounted to the proximal end of the probe housing; and a plurality of markers coupled to the body portion, the markers configured for viewing with a camera. The probe housing and the marker assembly may be configured for coupling in a fixed angular relationship about the body axis. The coupling may include a plurality of dowel pins mounted on one of the probe housing and the marker assembly for insertion into corresponding openings defined on the other of the marker assembly and the probe housing. In some embodiments, the plurality of markers may be configured for one of active emission and passive reflection and for detection by an infrared camera. In some embodiments, the probe holder assembly comprises a handle assembly having a distal end configured for selective coupling to the proximal end of the marker assembly.

[0026] Various embodiments of the probe holder assembly disclosed herein comprise a marker assembly including: a body portion defining a body axis extending through a proximal end and a distal end, the distal end of the body portion being mounted to the proximal end of the probe housing; a plurality of markers coupled to the body portion, the markers configured for viewing with a camera; and a handle assembly having a distal end configured for selective coupling to the proximal end of the marker assembly. The marker assembly may include a first connector at the proximal end of the body portion. In some embodiments, the handle assembly includes a second connector at the distal end of the handle assembly. When fully engaged, the first connector and the second connector may maintain the marker assembly and the handle assembly in a rotational relationship about a fixed axis. The first connector may be integral with the body portion of the marker assembly. In some embodiments, the first connector and the second connector include a polygonal interface for maintaining the rotational relationship. In some embodiments, the handle assembly includes a stem housed inside the guard portion and configured for axial translation to couple the second connector to the first connector, The first connector may be female and the second connector may be male.

[0027] Various embodiments disclosed herein include a method for positioning a probe on a patient for hands-free operation, the method including: providing a kit including an anchor assembly, a probe suspension assembly, and a probe housing; and providing instructions on a tangible, non-transitory medium, the instructions including: adhesively coupling a compliant cover portion of the anchor assembly to an anatomical location of the patient; depressing opposing plunger mechanisms on the probe suspension assembly to freely position the probe housing along a positioning axis of the anchor assembly; and releasing the opposing plunger mechanisms on the probe suspension assembly to couple the probe suspension assembly to the anchor assembly when the probe housing is in desired contact with the anatomical location of the patient. The instructions provided in the providing instructions may include, during the step of depressing the opposing plunger mechanisms, rotating the probe suspension assembly about a lateral axis of the probe suspension assembly to define a pitch angle of the probe housing relative to the positioning axis, the lateral axis being orthogonal to an actuation axis of the opposing plunger mechanisms.

[0028] In some embodiments, the instructions provided in the step of providing instructions include, during the step of depressing the opposing plunger mechanisms, rotating the probe suspension assembly about a central axis of the probe suspension assembly to define a pitch angle of the probe housing relative to a positioning axis, the central axis being orthogonal to an actuation axis of the opposing plunger mechanisms. The instructions provided in the step of providing instructions may include, during the step of depressing the opposing plunger mechanisms, rotating the probe suspension assembly about a lateral axis of the probe suspension assembly to define a pitch angle of the probe housing relative to a positioning axis, the lateral axis being orthogonal to the actuation axis of the opposing plunger mechanisms. In some embodiments, the step of releasing the opposing plunger mechanisms includes coupling a plurality of ties and holding tension on the ties. The probe housing may be coupled to the probe suspension assembly in the step of providing a kit. In some embodiments, the instructions in the step of providing instructions include coupling the probe housing to the probe suspension assembly.

[0029] Various embodiments disclosed herein include a method of orienting a probe on a patient for hands-free operation, the method comprising: providing a kit including a probe suspension assembly and a probe housing; and providing instructions on a tangible, non-transitory medium, the instructions including configuring a locking ring of the probe suspension assembly in a partially closed configuration, rotating the probe housing in the probe suspension assembly to a desired orientation, and configuring the locking ring to a fully closed configuration to secure the probe housing in the desired orientation. The rotating the probe housing may include defining a non-zero pitch angle between a probe axis of the probe housing and a ring axis of the probe suspension assembly. In some embodiments, the method includes executing the instructions provided in the providing instructions step. [Prior art documents] [Patent documents]

[0030] [Patent Document 1] U.S. Patent Application Publication No. 2020 / 0015780 [Brief explanation of the drawings]

[0031] [Figure 1] FIG. 1 is a perspective view of a probe holder assembly according to an embodiment of the present disclosure. [Figure 2] 2 is a side elevation cross-sectional view of the probe holder assembly of FIG. 1 according to an embodiment of the present disclosure. [Figure 3] 3 is a front elevation cross-sectional view of the probe holder assembly of FIG. 1 according to an embodiment of the present disclosure. [Figure 4] 4 is a proximal perspective view of a probe holder assembly kit including components of the probe holder assembly of FIG. 1 according to an embodiment of the present disclosure. [Figure 5] 5 is a distal perspective view of the probe holder assembly kit of FIG. 4 according to an embodiment of the present disclosure. [Figure 6] 6 is a proximal perspective view of an anchor assembly for the probe holder assembly of FIG. 1 according to an embodiment of the present disclosure. [Figure 7] 7 is a distal perspective view of the anchor assembly of FIG. 6 according to an embodiment of the present disclosure. [Figure 8] 8 is a partially exploded view of the anchor assembly of FIG. 6 according to an embodiment of the present disclosure. [Figure 9] 9 is a proximal perspective view of a probe suspension assembly for the probe holder assembly of FIG. 1 with a closure removed to reveal a clasp actuation mechanism according to an embodiment of the present disclosure. [Figure 10] 10 is a distal perspective view of the probe suspension assembly of FIG. 9 according to an embodiment of the present disclosure. [Figure 11] 11 is a top cutaway view of the probe suspension assembly of FIG. 9 in a partially closed configuration, according to an embodiment of the present disclosure. [Figure 12] 12 is a top cutaway view of the probe suspension assembly of FIG. 11 in a fully closed configuration, according to an embodiment of the present disclosure. [Figure 13] FIG. 13 is an enlarged cutaway view of inset XIII of FIG. 11, according to an embodiment of the present disclosure. [Figure 14] FIG. 14 is an enlarged cutaway view of inset XIV of FIG. 12, according to an embodiment of the present disclosure. [Figure 15] FIG. 15 is a plan view of an alternative probe suspension assembly for use with the probe holder assembly of FIG. 1 according to an embodiment of the present disclosure. [Figure 16] FIG. 16 is an enlarged view of the clasp actuation mechanism of FIG. 9 according to an embodiment of the present disclosure. [Figure 17] 17 is a cross-sectional view of the probe suspension assembly in plane XVII-XVII of FIG. 12 according to an embodiment of the present disclosure. [Figure 18] FIG. 18 is an enlarged partial cross-sectional view of inset XVIII of FIG. 17 according to an embodiment of the present disclosure. [Figure 19] 19 is a top view of the clasp actuation mechanism of FIG. 16 in an actuated state according to an embodiment of the present disclosure. [Figure 20] 20 is a proximal perspective view of a probe housing for the probe holder assembly of FIG. 1 according to an embodiment of the present disclosure. [Figure 21] 21 is a distal perspective view of the probe housing of FIG. 20 according to an embodiment of the present disclosure. [Figure 22] FIG. 22 is a proximal perspective view of a probe housing having a right cylindrical exterior surface according to an embodiment of the present disclosure. [Figure 23] 23 is a cross-sectional view of a locking ring for coupling to the probe housing of FIG. 22 according to an embodiment of the present disclosure. [Figure 24] 24 is a proximal perspective view of a marker assembly for the probe holder assembly of FIG. 1 according to an embodiment of the present disclosure. [Figure 25]25 is a distal perspective view of the marker assembly of FIG. 24 according to an embodiment of the present disclosure. [Figure 26] 26 is a front elevation view of a subassembly of the probe housing of FIG. 20 coupled to the marker assembly of FIG. 24 according to an embodiment of the present disclosure. [Figure 27] 27 is a side elevational view of a subassembly of the probe housing and marker assembly of FIG. 26 according to an embodiment of the present disclosure. [Figure 28] 28 is a proximal perspective view of a handle assembly for the probe holder assembly of FIG. 1 according to an embodiment of the present disclosure. [Figure 29] 29 is a distal perspective view of the handle assembly of FIG. 28 according to an embodiment of the present disclosure. [Figure 30] 30 is an elevational view of the handle assembly of FIG. 28 with a portion of the casing removed according to an embodiment of the present disclosure. [Figure 31] 31 is an elevational cross-sectional schematic view of a first total center of gravity for the rotatable components of the probe holder assembly of FIG. 1 according to an embodiment of the present disclosure. [Figure 32] 32 is an elevational cross-sectional schematic view of a second total center of gravity for the rotatable components of the probe holder assembly of FIG. 31 without the handle assembly, according to an embodiment of the present disclosure. [Figure 33] FIG. 33 is a partial cross-sectional elevation view of a probe holder assembly utilizing tie adjustment to create a pitch angle according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0032] Detailed Description 1-5, a probe holder assembly 30 is depicted according to an embodiment of the present disclosure. The probe holder assembly 30 includes an anchor assembly 32, a probe suspension assembly 34, a probe housing 36, a marker assembly 38, and a handle assembly 42. The components of the probe holder assembly 30 may be manufactured using only non-metallic materials such as polymers, rubber, and fabrics.

[0033] The r-θ-z coordinate system, which serves as the basis for direction and position nomenclature herein, is depicted in Figure 1. "Axial" refers to a direction parallel to the z coordinate; along the z coordinate, "proximal" is in the positive direction, "distal" is in the negative direction, and "lateral" is a direction perpendicular to the z coordinate. "Radial" refers to a direction along the r coordinate, and the modifiers "inward" and "outward" are toward and away from the z coordinate, respectively. "Tangential" refers to a direction consistent with the θ coordinate.

[0034] 6-8 , an anchor assembly 32 according to an embodiment of the present disclosure is depicted in greater detail. The anchor assembly 32 includes a compliant cover portion 60 defining an aperture 62, which defines and is concentric about a positioning axis 64. For purposes of illustration, the positioning axis 64 is assigned an origin O at the center of the aperture 62. A plurality of tie anchors 66 are coupled to the compliant cover portion 60. An adhesive layer 68 may cover a distal surface 72 of the compliant cover portion 60 and may also cover a distally facing surface 74 of the tie anchors 66. The anchor assembly 32 includes a plurality of ties 76, each connected to a corresponding one of the plurality of tie anchors 66. The ties 76 extend in a proximal direction 78.

[0035] In some embodiments, adhesive layer 68 is a sheet 70 having adhesive deposited on both sides with a distal protective barrier (not depicted) that can be peeled off to mount anchor assembly 32 on the patient. Alternatively, adhesive layer 68 may be established by coating distal surface 72 of compliant cover portion 60 when mounting anchor assembly 32 on the patient.

[0036] In some embodiments, the tie anchors 66 are coupled to the distal surface 72 of the compliant cover portion 60. Each tie anchor 66 may define a receptacle 82 that receives a head portion 84 of a corresponding tie 76 attached thereto. The tie anchors 66 may extend in a proximal direction 78 and a distal direction 80 through the compliant cover portion 60, e.g., through openings 86 formed in the compliant cover portion 60. The plurality of ties 76 may be cable ties (as depicted), commonly referred to as zip ties. In some embodiments, the compliant cover portion 60 is a mesh-like construction of, for example, a fabric, polymer, or rubber material.

[0037] In some embodiments, an information tag 88 is integrated into the anchor assembly 32. Information stored on the information tag 88 may be received by a wireless communication device 90 (FIG. 6). In some embodiments, the information tag 88 includes baseline information about the anchor assembly 32, such as a unique identifier, manufacturer, model, and manufacturing history. Such information may be encoded, for example, on a barcode tag that either includes the baseline information or is associated with it in a remote database. The remote database may be updated to include usage information, for example, time and date of use, type of use (e.g., for actual versus simulated treatment), and / or anonymized patient identification.

[0038] Information tag 88 may include local electronic memory capabilities that can be adapted to both be read from and written to, such as those provided by a radio frequency identification (RFID) chip or near field communication (NFC) tag and suitable wireless communication device 90. The read / write capability allows the local electronic memory to be updated to include usage information. In some embodiments, the storage capacity of the local electronic memory is in the range of 128 to 512 bits, inclusive.

[0039] In some embodiments, one or more electrocardiogram (ECG) sensors 92 are integrated into anchor assembly 32 ( FIG. 7 ). A cable assembly 94 may connect sensor 92 to an ECG module 96 for processing signals from ECG sensor 92. In some embodiments, leads from cable assembly 94 are routed under or through compliant cover portion 60 for connection to ECG sensor 92. ECG sensor 92 is arranged for operative coupling with the patient when compliant cover portion 60 is adhered to the patient. In some embodiments, the number of ECG sensors 92 integrated into anchor assembly 32 is in the range of one to six sensors, inclusive. ECG sensors 92, like anchor assembly 32, may be disposable.

[0040] The ECG sensor 92 may be combined with or associated with an information tag 88 for tracking usage information. Alternatively, or in addition, the cable assembly 94 may include an electronic read / write memory device 98, such as an erasable programmable read-only memory (EPROM). The memory device 98 may be accessed through the cable assembly 94, through the ECG module 96 or other processor, to expand or store the same baseline and / or usage information as the information tag 88. In some embodiments, the memory device 98 has a capacity of up to 20 kilobits.

[0041] Functionally, the mechanical flexibility of the compliant cover portion 60 allows for complete and uninterrupted contact of the adhesive layer 68 across any anatomical contours, thereby improving the strength of the bond to the patient. The conformality of the cover portion 60 reduces deformation of the anatomical contours relative to a rigid mounting interface for improved fine pressure management. The improved bond also allows the anchor assembly to remain secured to the patient for extended periods of time. The presence of the compliant cover portion 60, without the remaining components of the system, allows for visualization of the ultrasound probe position on a computed tomography (CT) scan without the presence of the ultrasound probe, thus eliminating potential artifacts on the CT image caused by the ultrasound probe. The compliant cover portion 60 can act as a template for easy marking of the patient's skin for later repositioning or remounting of the probe holder assembly 30.

[0042] The information tag 88 facilitates history tracking of the anchor assembly 32. In one embodiment, the anchor assembly 32 is removed from its packaging and the information tag 88 is read by the wireless communication device 90. The usage information may be updated, for example, in a remote memory or, for an information tag 88 so equipped, on a local memory. The usage information may facilitate, for example, ensuring that the anchor assembly 32 is utilized in a proper disposable manner or is not used for a different patient. The information tag 88 may also be used to track the history of other components of the probe holder assembly 30.

[0043] 9 and 10 , a probe suspension assembly 34 according to an embodiment of the present disclosure is depicted. The probe suspension assembly 34 includes a locking ring 102 that defines and is collinear with a ring axis 104. The locking ring 102 includes an inner surface 106 that faces radially inward toward the ring axis 104. The probe suspension assembly 34 also includes one or more clasps 108 coupled to the locking ring 102. In some embodiments, two such clasps 108 are disposed on opposite sides of the locking ring 102. The opposing clasps 108 may be centered about a central axis 112 of the probe suspension assembly 34 that extends perpendicular to the ring axis 104. A lateral axis 114 of the probe suspension assembly 34 may also be defined that is perpendicular to both the ring axis 104 and the central axis 112.

[0044] Locking ring 102 may be a bifurcated locking ring 102a defining two locking ring segments 102a' and 102a''. Locking ring segments 102a' and 102a'' may each be coupled to a pivot structure 122 extending from locking ring segments 102a' and 102a'' for rotation about a pivot axis 124, e.g., defined by a pivot pin 126. Locking ring segments 102a' and 102a'' may include opposite free ends 128 of respective pivot structures 122 that may be tangentially separated and selectively coupled to one another.

[0045] Probe holder assembly 30, probe suspension assembly 34, locking ring 102 and its interior surface 106, and probe housing 36 and its exterior surface 270 are collectively and generically referred to herein by their individual reference characters. Specific or individual embodiments of these components and attributes are referred to using letter suffixes (e.g., "probe suspension assembly 34a").

[0046] 11-14, a side view of the bifurcated locking ring 102a of the probe suspension assembly 34a is further described, according to an embodiment of the present disclosure. In some embodiments, the free ends 128 are selectively coupled to one another using a catch 140. The catch 140 may be pivotally coupled to one of the locking ring segments 102a′, 102a″, for example, using a pivot pin 142. In some embodiments, the catch 140 is pivotally mounted to a first one of the locking ring segments 102a′ and selectively attachable to a second one of the locking ring segments 102a″. The catch 140 may include a notch 144 and a protrusion 146. In some embodiments, the catch 140 is coupled to a finger loop 148 for actuation.

[0047] In some embodiments, the notch 144 and the protrusion 146 of the catch 140 are configured to selectively define a partially closed configuration 160 and a fully closed configuration 180. In the partially closed configuration 160 (FIG. 11), the notch 144 engages the first alignment surface 162 of the protrusion 146, defining a first maximum separation distance D1 between the midpoint 164 of the first lock ring segment 102 a′ and the midpoint 166 of the second lock ring segment 102 a″. In the fully closed configuration 180 (FIG. 12), the notch 144 engages the second alignment surface 182 of the protrusion 146, defining a second maximum separation distance D2 between the midpoint 164 of the first lock ring segment 102 a′ and the midpoint 166 of the second lock ring segment 102 a″. In some embodiments, the protrusion 146 includes a transition ramp 186 between the first and second alignment surfaces 162 and 182. The first maximum separation distance D1 of the partially closed configuration 160 exceeds the second maximum separation distance D2 of the fully closed configuration 180.

[0048] In operation, the probe housing 36a is captured by the bifurcated locking ring 102a in both the partially closed configuration 160 and the fully closed configuration 180. In the partially closed configuration 160, the first maximum separation distance D1 may be sized to laterally restrain the probe housing 36a and prevent substantial radial translation within the locking ring segments 102a′ and 102a″, while allowing rotation of the probe housing 36a with little resistance. In the fully closed configuration 180, the second maximum separation distance D2 may be configured to firmly clamp the probe housing 36a between the locking ring segments 102a′ and 102a″, thereby maintaining the probe housing 36a in a fixed angular relationship with the probe suspension assembly 34a.

[0049] Referring to FIG. 15 , a probe suspension assembly 34b having a continuous locking ring 102b is depicted according to an embodiment of the present disclosure. The probe suspension assembly 34b may include some of the same components and attributes as the probe suspension assembly 34a, some of which are indicated by identically labeled reference characters. In some embodiments, the continuous locking ring 102b is sufficiently resilient and elastic to allow structures on the exterior surface of the probe housing 36a (e.g., exterior surfaces 270, 270a in FIGS. 20 and 21 ) to penetrate into the continuous locking ring 102b and subsequently maintain sufficient contact to statically secure the probe housing 36a to the probe suspension assembly 34b by frictional force. The frictional force may be of a magnitude that can be selectively overcome by hand. In some embodiments, the frictional force is overcome by a torsion applied to the housing 36a about the collinear ring and probe axes 104 and 268 that exceeds a value within the range of 1 to 2.5 Newton-meters (inclusive).

[0050] 16-19, aspects of the clasp 108 of the probe suspension assembly 34, according to certain embodiments of the present disclosure, are further described. Each clasp 108 includes an actuation mechanism 200 having a plunger 202 coupled to a nib 204 for engaging a locking structure 206 defined by a respective one of the plurality of ties 76. The nib 204 may be a detent 208 that engages a notch 212 formed on the tie 76. In some embodiments, the locking structure 206 comprises a plurality of notches 212 for defining a sawtooth profile 214, such as those defined on commercially available ZIP-TIEs. Alternative locking structures 206 (e.g., through apertures, perforations, high-friction surfaces) are not depicted but may be readily implemented by those skilled in the art in light of the teachings of the present disclosure and are considered within the scope of the present disclosure.

[0051] Actuation mechanism 200 may be mounted to a bracket 220 that is attached to locking ring 102. Bracket 220 may extend radially outward from locking ring 102. In some embodiments, actuation mechanism 200 is housed within a closure 222 that is coupled to bracket 220. Bracket 220 may be configured to receive and allow passage of one or more of multiple ties 76 therethrough, for example, via a through passage 224 defined by bracket 220, closure 222, or both.

[0052] In some embodiments, actuation mechanism 200 includes a biasing element 226 that biases nib 204 into engagement with tie 76. For example, nib 204 may be disposed on a lever 228 that is coupled to plunger 202 (depicted). Lever 228 may be pivotally coupled to bracket 220 using, for example, pivot pin 232.

[0053] Biasing element 226 may include a flexure 242 that is integral with or unitary to plunger 202 (as depicted). Other biasing elements (e.g., coil springs, spring arms, leaf springs, resilient blocks) not depicted herein, but may be incorporated by one of ordinary skill in the art in light of the teachings of the present disclosure, are considered to be within the scope of the present disclosure.

[0054] In the depicted embodiment, the catch 108 is configured to initially engage a respective one of the plurality of ties 76 and is released upon actuation of the actuation mechanism 200. Alternatively, the actuation mechanism 200 may be arranged to initially engage a disengagement configuration (not depicted) and, upon actuation, engage the nib 204 and secure it to the tie 76. Also, in the depicted embodiment, the nib 204 is disposed on the lever 228. Alternatively, or in addition, the nib 204 may be affixed to the bracket 220 rather than the lever 228, and the tie 76 may be arranged such that the locking structure 206 of the tie 76 engages the bracket 220 (i.e., the nib 204 on the bracket 220) for retention.

[0055] In operation, biasing element 226 maintains engagement between nib 204 and locking structure 206 ( FIG. 18 ) of tie 76. An actuation force F is applied to urge plunger 202 radially inward, overcoming the bias of plunger 202 and disengaging nib 204 from tie 76 ( FIG. 19 ). In the depicted embodiment, application of actuation force F rotates lever 228 about pivot pin 232 and away from tie 76, thereby releasing nib 204 from tie 76 and correspondingly releasing probe suspension assembly 34 from anchor assembly 32.

[0056] For embodiments having clasps 108 on opposite sides of the locking ring 102, the plunger 202 may be aligned along the actuation axis 203 such that opposing actuation forces F cancel each other (e.g., FIG. 15 ), thereby maintaining the probe suspension assembly 34 in equilibrium across the anchor assembly 32 during actuation by the operator. In some embodiments, the actuation axis 203 may be parallel to and collinear with the central axis 112 of the probe suspension assembly 34 a. Disengagement of the nib 204 from the tie 76 allows the probe suspension assembly 34 to be axially translated in the proximal and distal directions 80 and 78 along the positioning axis 64, with the tie 76 passing through the probe suspension assembly 34. When the probe suspension assembly 34 is at the desired axial location along the positioning axis 64, the operator releases the plunger 202, and the biasing element 226 acts to push the plunger 202 radially outward, thereby pivoting the lever 228 about the pivot pin 232 and restoring engagement between the nib 204 and the locking structure 206 of the tie 76.

[0057] Functionally, the probe suspension assembly 34 and anchor assembly 32 cooperate to apply an axial force on the patient during hands-free operation. The hands-free aspect reduces the number of components required to obtain high-quality ultrasound (e.g., by elimination of the handle assembly 42 in hands-free mode). Repeated bidirectional positioning of the probe suspension assembly 34 along the positioning axis 64 controls pressure at the probe housing 36 and patient interface and the associated distortion to the skin, which can be adjusted to improve ultrasound image quality.

[0058] 20 and 21 and again with reference to FIGS. 2 and 3 , a probe housing 36 for housing an ultrasound probe is depicted according to an embodiment of the present disclosure. The probe housing 36 includes a proximal end 262 and a distal end 264 separated by a sidewall 266. The proximal end 262, the distal end 264, and the sidewall 266 define and are concentric about a probe axis 268. An outer surface 270 of the probe housing 36 is configured to engage the inner surface 106 of the locking ring 102. The probe housing 36 may be configured for coupling with the locking ring 102 of the probe suspension assembly 34 adjacent the distal end 264 of the probe housing 36. In some embodiments, the proximal end 262 includes one or more dowel pins 272 extending axially in the proximal direction 78 and may include a tapped hole 274 configured to receive a fastener (not depicted).

[0059] The inner and outer surfaces 106a and 270a may define complementary profiles for capture of the probe housing 36a within the locking ring 102 of the probe suspension assembly 34. In some embodiments, the profile of the outer surface 270a of the sidewall 266 is convex and the profile of the inner surface 106a of the locking ring 102 is concave (as depicted). The complementary profiles of the outer and inner surfaces 106a and 270a may define an arcuate profile. In some embodiments, the outer and inner surfaces 106a and 270a define a spherical section.

[0060] In some embodiments, the distal end 264 of the probe housing 36 includes an ultrasound lens 276 for directing ultrasound waves emitted from the ultrasound probe. The ultrasound lens 276 may include a polyamide material. In some embodiments, the ultrasound lens 276 is formed by an injection molding process. The probe housing 36 may include a feedthrough 278 for the passage of wires and cables for the ultrasound probe. In some embodiments, the feedthrough 278 may face radially outward and be located adjacent the proximal end 262 of the probe housing 36.

[0061] Functionally, the combination of the probe suspension assembly 34 and the probe housing 36 enables "hands-free" ultrasound imaging by holding the probe housing 36 in a desired position and orientation on the patient without the application of external forces. Substantially free rotation of the probe housing 36 is permitted about a fixed point on the patient while the probe housing 36 is in contact with the patient. For embodiments in which the exterior and interior surfaces 106 and 270 define spherical or otherwise arcuate, complementary sections (e.g., exterior and interior surfaces 106a and 270a), the probe suspension assembly 34 (e.g., 34a) and the probe housing 36 (e.g., 36a) act as gimbals to orient the probe housing at an arbitrary pitch angle φ ( FIGS. 31 and 32 ) about the ring axis 104. The desired location and rotational orientation of the probe housing 36 is fixed in place for extended periods of hands-free ultrasound imaging. The use of non-metallic materials for components away from the ultrasound probe reduces metal artifacts in CT imaging. The location of the feedthrough 278 allows the ultrasound probe wires and cables to be spaced away from the patient's skin, further reducing metal artifacts in CT images. The configuration of the proximal end 262 of the probe housing 36 allows for secure and precise fixation of components (e.g., the marker assembly 38) to the probe housing 36.

[0062] 22 and 23, a probe housing 36c and a probe suspension assembly 34c are depicted according to an embodiment of the present disclosure. The housing 36c and the suspension assembly 34c may include many of the same components and attributes as the probe housing 36a and the probe suspension assemblies 34a, 34b, some of which are identified using identically labeled reference characters. Characteristic aspects of the probe housing 36c and the locking ring 102c of the suspension assembly 34c are the right cylindrical exterior and interior surfaces 270c and 106c. The locking ring 102c may be a bifurcated structure, such as that depicted for the probe suspension assembly 34a, or a continuous structure, such as that depicted for the probe suspension assembly 34b.

[0063] In some embodiments, a further distinctive aspect of the probe housing 36c and probe suspension assembly 34c is a locking pin 282 and a locking groove 284. The locking pin 282 may extend radially outward from the exterior surface 270c of the probe housing 36c (depicted), with the locking groove 284 defined by the interior surface 106c of the locking ring 102c (depicted) and sized to receive the locking pin 282. Alternatively, in some embodiments (not depicted), the pin and groove structures 282 and 284 may instead be located on the locking ring 102c and the probe housing 36c, respectively.

[0064] In some embodiments, locking groove 284 includes a cam structure 288 that defines an access portion 286 and leads to a detent 290. Cam structure 288 may include a lead-in structure 292 at access portion 286. Cam structure 288 may define an axial extension 294 that leads into a tangential extension 296 (depicted) that terminates at detent 290. Alternatively, cam structure 288 may define a helical shape (not depicted) about ring axis 104 that leads to detent 290.

[0065] 22 and 23. However, multiple such locking pins 282 and locking grooves 284 are also envisioned. In some embodiments, multiple locking pins 282 and locking grooves 284 are uniformly distributed about the ring axis 104 for multiple rotational orientations of the probe housing 36c within the probe suspension assembly 34c. Alternatively, multiple locking pins 282 and locking grooves 284 may be non-uniformly distributed about the ring axis 104 to wedge the probe housing 36c and the probe suspension assembly 34c in fixed rotational orientations relative to one another.

[0066] In assembly, the probe housing 36c and the probe suspension assembly 34c are aligned such that their respective axes 269 and 104 are collinear and rotated so that the locking pin 282 is aligned with the access 286 of the locking groove 284. The probe housing 36c is inserted into the locking ring 102c such that the locking pin 282 enters the locking groove 284. The locking pin 282 may be guided into the detent 290 by the cam structure 288 with a translational and twisting action between the probe housing 36c and the locking ring 102c.

[0067] The positioning of the access 286 in the locking groove 284 may be arranged to accommodate the feedthrough 278 of the probe housing 36c. That is, for embodiments in which the locking groove 284 is defined by the locking ring 102c (depicted in FIG. 23), the access 286 will face toward the feedthrough 278 (i.e., in the proximal direction 78 in FIG. 23). For embodiments in which the locking groove 284 is defined by the probe housing 36 (not depicted), the access 286 will face away from the feedthrough 278 (i.e., in the distal direction 80 in FIG. 22). These arrangements allow the probe housing 36c to be seated within the locking ring 102c without interference from the feedthrough 278.

[0068] Functionally, the probe housing 36c and the probe suspension assembly 34c define a torsional locking arrangement, much like a bayonet connector, in which a locking pin 282 and a locking groove 284 cooperate to secure the probe housing 36c to the probe suspension assembly 34c. The locking pin 282 is inserted into the locking groove 284 and is guided into a detent 290 by a cam structure 288. The locking pin 282 remains aligned within the detent 290 by an axial force, e.g., with the probe housing 36c contacting the patient by a reaction force. A retraction structure 292 acts to guide the locking pin 282 into the locking groove 284.

[0069] Embodiments are also contemplated in which the probe housing 36c does not include the locking pin 282 and locking groove 284, where the probe housing 36c is held securely within the probe suspension assembly 34c by a clamping force provided by the locking ring 102c (e.g., in a bifurcated ring arrangement) or by a frictional force between the outer surface 270c of the probe housing 36c and the inner surface 106c of the locking ring 102c (e.g., in a continuous ring arrangement). The frictional force may be of a magnitude that can be selectively overcome by hand. In some embodiments, the frictional force is overcome by a torsion applied to the probe housing 36c about the collinear ring and probe axes 104 and 268 that exceeds a value within the range of 1 to 2.5 Newton-meters (inclusive).

[0070] 24-27 and again with reference to FIGS. 2 and 3 , a marker assembly 38 is depicted according to an embodiment of the present disclosure. Marker assembly 38 includes a body portion 302 defining a body axis 304 extending through a proximal end 306 and a distal end 308, the distal end 308 of body portion 302 configured for mounting to the proximal end 262 of probe housing 36. A plurality of markers 322 are coupled to body portion 306, the markers 322 configured for viewing with a camera (not depicted). In some embodiments, body portion 302 defines or includes a body connector 324 accessible from proximal end 306. In the depicted embodiment, body connector 324 presents a flange portion 326 for mating with handle assembly 42.

[0071] The markers 322 may be infrared reflective and the camera may be an infrared camera. The markers 322 may be arranged according to a tracking system protocol defined by the tracking system manufacturer. One example of such a protocol is found in the "Polaris Tool Design Guide" (Revision 6, 2018) for the POLARIS® SPECTRA® System, manufactured by NDI (Waterloo, Ontario, Canada).

[0072] The probe housing 36 and the marker assembly 38 are coupled in a fixed angular relationship about a body axis 304 and are configured to maintain the body axis 304 of the marker assembly 38 and the probe axis 268 of the probe housing 36 in a generally collinear alignment. The distal end 308 of the body portion 302 may define a dowel opening 328 configured to receive the dowel pin 272 of the probe housing 36. Alternatively, the marker assembly 38 may include a distally protruding dowel pin received by a dowel opening defined by the probe housing 36 (not depicted). In some embodiments, the distal end 308 of the body portion 302 defines a through opening 330 for receiving a fastener (not depicted), the through opening 330 aligning with the tapped hole 274 of the probe housing 36 within the assembly.

[0073] Functionally, the marker assembly 38 allows for the placement of active or passive markers 322 for use with a camera to track the position of the probe housing 36. The arrangement of markers 322 further allows for tracking of the position of the probe housing 36 from a variety of different tracker locations.

[0074] 28-30 and again with reference to FIGS. 2 and 3 , a handle assembly 42 is depicted according to an embodiment of the present disclosure. Handle assembly 42 includes a proximal end 342 and a distal end 344 separated by a casing 346. Proximal end 342, distal end 344, and casing 346 define and are concentric about a handle axis 348. Casing 346 may include two casing portions 346′ and 346″ joined together to form an interior chamber 362 of casing 346. One or more bosses 364 extend from casing 346 into interior chamber 362 and may receive fasteners (not depicted) for securing casing portion 346′ to casing portion 346″.

[0075] The distal end 344 includes a handle connector 366 configured to mate with the body connector 324 of the marker assembly 38. In some embodiments, the handle assembly 42 includes a handle plunger 368 extending from the proximal end 342 into the distal end 344. The handle plunger 368 is accessible from the proximal end 342 and may include a push button 382 that can be actuated, for example, by the thumb or palm of an operator. In some embodiments, the handle connector 366 includes a connector feature 384 depending from the handle plunger 368 and extending into or through the distal end 344 of the handle assembly 42, the feature 384 configured to engage the body connector 324 of the marker assembly 38. The handle plunger 368 may include a stop 386 that engages the casing 346 and prevents overextension of the handle plunger 368 within the casing 346 in either the proximal or distal directions 78, 80 using an opening 388 defined on the handle plunger 368 that engages, for example, the boss 364.

[0076] The handle connector 366 may include guides 390 for alignment and stability of the connection with the marker assembly 38. In some embodiments, the handle plunger 368 is coupled to the casing 346 using one or more biasing elements 392 to bias the handle plunger 368 in the proximal direction 78. The handle plunger 368 may be configured to deflect the connector features 384 radially inward (i.e., toward the handle axis 348) when actuated in the distal direction 80 within the casing 346, for example, by interaction between a ramp 394 structure on the handle plunger 368 and a deflector shoulder 396 coupled to the interior of the casing 346.

[0077] In assembly, the probe housing 36 and the marker assembly 38 are secured to one another by, for example, an interference fit between a plurality of dowel pins 272 and corresponding dowel openings 328. In some embodiments, a fastener (not depicted) is inserted into the through opening 330 in the distal end 308 of the body portion 302 of the marker assembly 38 and threaded into the tapped hole 274 in the proximal end 262 of the probe housing 36, thereby securing the marker assembly 38 to the probe housing 36. In some embodiments, the coupling of the probe housing 36 and the marker assembly 38 comprises an interference fit between the proximal end 262 of the probe housing 36 and the distal end 308 of the body portion 302 of the marker assembly 38.

[0078] The probe housing 36 is coupled to the probe suspension assembly 34. For probe suspension assembly 34a, the probe housing 36 is coupled to the locking ring 102 by opening the bifurcated locking ring 102a and securing the probe housing 36 in either the partially closed configuration 160 or the fully closed configuration 180. For probe suspension assembly 34b, the probe housing 36 is press-fit into the continuous locking ring 102b to snap into place. A plurality of ties 76 are fed through the through passage 224 of the probe suspension assembly 34, for example, by depressing the plunger 202 of the probe suspension assembly 34 radially inward. The probe suspension assembly 34 is coupled to the plurality of ties 76 at any axial location along the positioning axis 64, for example, by releasing the plunger 202.

[0079] The handle assembly 42 is coupled to the marker assembly 38, for example, by aligning guides 390 at the distal end 344 of the handle assembly 42 with complementary structure on the marker assembly 38 and inserting the connector features 384 of the hand plunger 368 into the handle connector 366 at the proximal end 306 of the marker assembly 38. The handle assembly 42 is secured to the marker assembly 38 by, for example, a clipping action that mates the connector features 384 with the body connector 324. The connection may be maintained by a proximal bias applied by a biasing element 392.

[0080] In operation, the anchor assembly 32 is adhesively coupled to the patient at the desired anatomical location. Ultrasound gel (not depicted) may be applied to the patient within the opening 62 of the compliant cover portion 60 for improved ultrasound coupling. In some embodiments, the axial positioning procedure includes releasing the probe suspension assembly 34 from the anchor assembly 32 for free and repeatable translation of the probe suspension assembly 34 in both the proximal and distal directions 78 and 80 along the positioning axis 64. The probe suspension assembly 34 is repeatedly adjusted in this manner until the probe housing 36 (e.g., the ultrasound lens 276) is at the desired axial location relative to the anchor assembly 32. Determining the desired axial location can involve such free and repeatable positioning, in addition to intermittent locking of the probe suspension assembly 34 to the anchor assembly 32, to check ultrasound image quality without the application of external forces (i.e., in a “hands-free” state). In the hands-free state, the ties 76 are in tension, thereby maintaining the force exerted by the probe housing 36 on the patient.

[0081] As explained above, for the depicted embodiment, release of the probe suspension assembly 34 from the ties 76 of the anchor assembly 32 for free translation along the positioning axis 64 is accomplished by depressing the plunger 202 radially inward toward the positioning axis 64. This aspect of the present disclosure is non-limiting. In light of the teachings of the present disclosure, an operator or person skilled in the art can mutatis mutandis configure or operate a probe holder assembly 30 that allows free and repeatable positioning without plunger actuation and locks the probe suspension assembly 34 to the anchor assembly 32 by actuation of a plunger or similar structure. Thus, the assembly and operation procedures are not limited to the depicted embodiment.

[0082] 31 and 32, pitch and rotation adjustments of the probe holder assembly 30a are depicted according to an embodiment of the present disclosure. For embodiments utilizing the probe housing 36a and probe suspension assembly 34a or 34b, the probe housing 36a can be rotated within the locking rings 102a, 102b and about the ring axis 104 and oriented at a pitch angle φ defined between the ring axis 104 and the probe axis 268. The axial location of the probe suspension assemblies 34a, 34b relative to the anchor assembly 32 may remain fixed during pitch and rotation adjustments. The ring and positioning axes 104 and 64 remain in a fixed relationship relative to one another, and the probe, body, and handle axes 268, 304, and 348 also remain in a fixed relationship relative to one another during pitch and rotation adjustments.

[0083] For the probe suspension assembly 34a, adjustment is made by configuring the bifurcated locking ring 102a into a partially closed configuration 160 (FIGS. 11 and 13). An operator may use the finger loops 148 of the probe suspension assembly 34a to manipulate the bifurcated locking ring 102a into the partially closed configuration 160. In the partially closed configuration 160, the probe housing 36 and marker assembly 38 can rotate and pitch about the ring axis 104 with little resistance.

[0084] With respect to the probe suspension assembly 34b, rotational adjustment of the probe housing 36a is achieved by overcoming the frictional forces between the inner surface 106a of the continuous locking ring 102b and the outer surface 270a of the probe housing 36a. The handle assembly 42 can facilitate this process. Once the desired pitch and rotational orientation of the probe housing 36a is achieved, the operator simply releases their grip on the handle portion. The probe housing 36a is maintained in the released rotational orientation by the frictional forces on the inner and outer surfaces 106a and 270a.

[0085] Once the desired pitch and rotational adjustments have been made, the bifurcated locking ring 102a is configured into a fully closed configuration 180 (FIGS. 12 and 14), securing the probe housing 36 in the desired rotational orientation. An operator may use the finger loops 148 of the probe suspension assembly 34a to manipulate the bifurcated locking ring 102a into the fully closed configuration 180. In the fully closed configuration 180, the probe housing 36 and marker assembly 38 are firmly held in the desired rotational orientation by the bifurcated locking ring 102a.

[0086] With the probe housing 36 configured in a desired position and orientation for operation, the handle assembly 42 may be removed. The handle connector 366 of the handle assembly 42 is uncoupled from the body connector 324 of the marker assembly 38, and the handle assembly 42 is disengaged. In the depicted embodiment, uncoupling of the handle connector 366 is accomplished by depressing the push button 382 into the casing 346, causing the ramp 394 of the handle plunger 368 to engage the deflector shoulder 396 of the casing 346, thereby deflecting the connector feature 384 radially inward, toward the handle axis 348, and away from the flange 326 of the body connector 324. The handle assembly 42 can then be withdrawn in a direction parallel to the handle axis 348.

[0087] Any combination of the disclosed probe housing 36, marker assembly 38, and handle assembly 42 is referred to herein as a rotatable component 398, where “rotatable” refers to the ability to both rotate about and pitch relative to the positioning axis 64. Returning to FIGS. 31 and 32 , removal of the handle assembly 42 has the effect of shifting the center of gravity of the rotatable component 398 and reducing the mass associated with that center of gravity. Generally speaking, the rotatable components 398 present for a given configuration can be characterized as establishing an aggregate center of gravity CG, where “aggregate” refers to a given combination of rotatable components 398. The aggregate center of gravity CG is further characterized as being located a moment arm MA from the origin O of the positioning axis 64 (i.e., the center of the opening 62 in the compliant cover portion 60). Total mass M is defined as the sum of the masses of the rotatable components 398 and is characterized as being located at the aggregate center of gravity CG. For applications in which the positioning axis 64 and ring axis 104 are not aligned with the gravity vector G, the gravity vector will induce a moment about the origin O proportional to the product of the total mass M and the moment arm MA.

[0088] To facilitate the axial positioning and rotational orientation procedures, the handle assembly 42 can be part of a rotatable component 398 that establishes a first total center of gravity CG1 of the rotating components, including the probe housing 36, the marker assembly 38, and the handle assembly 42 ( FIG. 31 ). The first total center of gravity CG1 is located a first moment arm MA1 from the origin O of the positioning axis 64 (i.e., the center of the opening 62 in the compliant cover portion 60). The total mass M1 is the sum of the masses of the rotatable component 398 (the masses of the probe housing 36, the marker assembly 38, and the handle assembly 42). For applications in which the positioning axis 64 and the ring axis 104 are not aligned with the gravity vector G, the gravity vector will induce a moment about the origin O that is proportional to the first total mass M1 and the first moment arm MA1.

[0089] Once the probe housing 36 is secured in the desired location and orientation, the handle assembly 42 can be removed. In response to removal, a second total center of gravity CG2 is defined at the second moment arm MA2 and the second total mass M2 ( FIG. 32 ). Because the handle assembly 42 is removed from the rotatable component 398, both the second moment arm MA2 and the second total mass M2 are reduced relative to the first moment arm MA1 and the first total mass M1. Thus, any moments about the origin O are reduced by the removal of the handle assembly 42.

[0090] Functionally, the handle assembly 42 enhances one-handed manipulation of the probe housing 36 for adjustment of ultrasound images. The reduced mass M2 and moment arm MA2 about the origin O of the positioning axis 64 upon removal of the handle assembly 42 reduces the moment canceled by the anchor assembly 32 and the attendant distortion of anatomical structures proximate the contact area of ​​the probe housing 36.

[0091] The various assembly and operation procedures described above are not limited to being sequential; that is, the steps performed in the assembly and operation procedures may be intermixed. For example, the operation step for mounting the anchor assembly 32 to the patient may occur before the step of coupling the probe suspension assembly 34 to the plurality of ties 76. In another embodiment, the steps of the rotational adjustment procedure of the probe housing 36 may be intermixed with or incorporate the steps of the axial positioning procedure of the probe housing 36.

[0092] Referring to FIG. 33 , a probe holder assembly 30c utilizing tie connection length adjustment to effect pitch angle φ is depicted according to an embodiment of the present disclosure. Probe holder assembly 30c includes many of the same components and attributes as probe holder assembly 30a, identified using identically labeled reference characters. The difference in probe holder assembly 30c is the use of a probe suspension assembly 34c having right cylindrical surfaces 106c and 270c. Thus, probe holder assembly 30c does not include a gimbal structure for adjusting pitch angle φ. Rather, pitch angle φ is established by connections to various ties 76 at different axial locations L along positioning axis 64.

[0093] The ties 76 are individually identified in FIG. 6 as ties 76.1, 76.2, 76.3, and 76.4, with ties 76.1 and 76.3 and ties 76.2 and 76.4 separated laterally (i.e., separated parallel to the lateral axis 114). In FIG. 33, connections to ties 76.1 and 76.2 at different axial locations L1 and L2, respectively, are illustrated. As a result, the probe suspension assembly 34c is tilted between ties 76.1 and 76.2, defining a pitch angle φ of the ring axis 104 relative to the positioning axis 64. This is in contrast to the gimbal structure arrangement of FIGS. 31 and 32, in which the pitch angle φ is defined between the ring axis 104 and the probe axis 268.

[0094] In some embodiments, a clasp 108 is utilized to approximate the different axial locations L1 and L2. The clasp 108 is not visible in the cross-sectional view of FIG. 33 but is depicted in an actuated state in FIGS. 17-19. In the depicted embodiment, the plunger 202 is actuated with opposing actuation forces F, causing the probe suspension assembly 34c to rotate about its lateral axis 114. Actuation of the plunger 202 releases the clasp 108 from the tie 76, allowing substantial free rotation about the lateral axis 114 as the clasp 108 slides along the tie 76. At the desired pitch angle φ, the plunger 202 is released or deactivated, causing the clasp 108 to re-engage the tie 76 at the different axial locations L1 and L2, thereby maintaining the pitch angle φ.

[0095] In some embodiments, alternatively or additionally, the probe suspension assembly 34c may be rotated about its central axis 112 during release of the clasp 108. A different axial location L is thereby established between laterally adjacent ties 76.1 and 76.3 and laterally adjacent ties 76.2 and 76.4 (identified in FIG. 6 ). Rotation about the central axis 112 defines a pitch angle φ in a plane that is not parallel to the central axis 112.

[0096] During rotation of the probe suspension assembly 34c about the central and / or lateral axes 112, 114, the probe or probe housing 36c may be translated along the ring axis 104 to a position or approximate position of the distal end 264 of the probe or probe housing 36c within the opening 62 of the anchor assembly 32. The tie 76 may be drawn taut against the compliant cover portion 60 while maintaining the pitch angle φ for improved contact between the probe or probe housing 36 and the patient.

[0097] Functionally, the tie length adjustment technique allows for adjustment of the pitch angle φ without the complexity of a gimbal structure. This technique can be implemented for a locking ring 102c with a right cylindrical inner surface 106c (as depicted) and with a suspension assembly that does not include a locking ring at all. Alternatively, this technique can also be used in combination with a gimbal structure (e.g., with the probe suspension assembly 34a), e.g., to provide coarse adjustment of the pitch angle φ while using the gimbal structure to finely adjust the pitch angle φ.

[0098] In some embodiments, some or all of the components of the disclosed probe holder assembly 30 are provided as a kit 400 (depicted in FIGS. 4 and 5). In addition to the components depicted in FIGS. 4 and 5, the kit 400 may also include a probe (not depicted), for example, an ultrasound probe configured for coupling into the probe housing 36. The kit may include instructions for use 402. The instructions 402 may be provided on tangible, non-transitory media and physically included with the kit 400, such as on a printed document (depicted), a compact disc, or a flash drive. Non-limiting examples of tangible, non-transitory media include paper documents, and computer-readable media include compact discs and magnetic storage devices (e.g., hard disks, flash drives, cartridges, floppy drives). The computer-readable media may be local or accessible via the internet. The instructions 402 may be complete on a single medium or split across two or more media. For example, some of the instructions 402 may be written on a paper document instructing a user to access one or more of the method steps via the Internet, and the Internet-accessible steps may be stored on a computer-readable medium or media. The instructions 402 may embody the techniques and methods depicted or described herein using text, pictures, videos, or a combination thereof to instruct and guide the user. The instructions 402 may be in the form of written words, diagrams, pictures, video presentations, or a combination thereof to instruct and guide the user.

[0099] The following references are included: International Patent Application No. WO 2022 / 136925 to Camps et al., filed December 23, 2021; International Patent Application No. WO 2021 / 094824 to Camps et al., filed November 11, 2020; International Patent Application No. WO 2019 / 096943 to Garonna et al., filed November 15, 2018; International Patent Application No. WO 2017 / 052363 to Tchang, et al.; International Patent Application No. WO 2010 / 017295 to Vezina; U.S. Patent Application Publication No. 2020 / 0015780 to Geelen et al.; U.S. Patent Application Publication No. 2020 / 0178932 to Te Velde et al.; U.S. Patent Application Publication No. 2014 / 0107435 to Puy et al., European Patent No. 0327459 to Puy et al., U.S. Patent No. 4,483,344 to Atkov et al., and the "Polaris Tool Design Guide," Revision 6 (NDI, Waterloo, Ontario, Canada) 2018, are incorporated herein by reference in their entireties. Any incorporation by reference of the above documents into this specification is limited to not incorporating any subject matter that is inconsistent with the explicit disclosure herein. Any incorporation by reference of the above documents is further limited to not incorporating by reference any claims contained herein. Any incorporation by reference of the above documents is still further limited to not incorporating by reference any definitions provided within this document, unless expressly included herein.

[0100] Each additional figure and method disclosed herein can be used separately or in conjunction with other features and methods to provide improved devices and methods for making and using the same. Thus, combinations of features and methods disclosed herein may not be necessary to practice the present disclosure in its broadest sense, but instead are disclosed solely to specifically describe exemplary and preferred embodiments.

[0101] Various modifications to the embodiments may become apparent to those skilled in the art upon perusal of this disclosure. For example, those skilled in the art will recognize that various features described with respect to different embodiments may be suitably combined, not combined, recombined with other features, alone, or in different combinations. Similarly, all of the various features described above should be considered as exemplary embodiments, not limitations on the spirit or scope of the disclosure.

[0102] Those skilled in the art will recognize that various embodiments may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not intended to be an exhaustive representation of the ways in which various features may be combined. Thus, the embodiments are not mutually exclusive combinations of features; rather, the claims may include combinations of different individual features selected from different individual embodiments, as would be understood by one of skill in the art.

[0103] Unless otherwise indicated, references contained herein to "embodiment(s)," "disclosure," "present disclosure," "embodiment(s) of the disclosure," "disclosed embodiment(s)," and the like refer to the specification (text and figures, including the claims) of this patent application, which is not admitted prior art.

[0104] For purposes of claim interpretation, it is expressly intended that the provisions of 35 U.S.C. 112(f) shall not be invoked unless the specific terms "means for" or "step for" are recited in an individual claim.

Claims

1. 1. A probe holder assembly comprising: a probe housing for containing a probe, the probe housing including a proximal end and a distal end separated by a sidewall having an exterior surface; 1. An anchor assembly comprising: a compliant cover portion defining an opening for passage of the distal end of the probe housing, the opening defining a positioning axis and being collinear therewith; an adhesive layer covering a distal surface of the compliant cover portion; a plurality of ties coupled to the compliant cover portion and extending proximally therefrom; an anchor assembly including: a probe suspension assembly for coupling to the probe housing and the anchor assembly, a locking ring defining a ring axis and collinear therewith, the locking ring having an inner surface configured to engage an outer surface of a sidewall of the probe housing to secure the locking ring to the probe housing; one or more clasps for selectively gripping, applying tension to, and maintaining tension on a plurality of ties of the anchor assembly, the one or more clasps being coupled to the locking ring; a probe suspension assembly including: Equipped with The probe holder assembly, wherein the probe suspension assembly is separated from the compliant cover portion by the plurality of ties.

2. The probe holder assembly of claim 1 , wherein the anchor assembly includes a plurality of tie anchors attached to the compliant cover portion, each of the plurality of tie anchors being connected to a corresponding one of the plurality of ties.

3. The probe holder assembly of claim 1 , wherein an inner surface of the locking ring and an outer surface of the probe housing are configured to statically secure the locking ring to the probe housing by frictional forces.

4. The probe holder assembly of claim 3 , wherein the frictional force is of a magnitude that can be selectively overcome by hand.

5. 5. The probe holder assembly of claim 4, wherein the frictional force is overcome by a torsion applied to the probe housing about the ring axis that exceeds the range of 1 to 2.5 Newton meters, inclusive.

6. The probe holder assembly of claim 1 , wherein the probe housing is configured for mating with a locking ring of the probe suspension assembly proximate a distal end of the probe housing.

7. The probe holder assembly of claim 1 , wherein the one or more fasteners are adjustable along the plurality of ties to define a pitch angle of the ring axis relative to the locating axis.

8. The probe holder assembly of claim 1 , further comprising an information tag coupled to the compliant cover portion.

9. The probe holder assembly of claim 1 , further comprising an electrocardiogram (ECG) sensor coupled to the compliant cover portion.

10. The probe holder assembly of any one of claims 1-9, wherein the locking ring is continuous.

11. The probe holder assembly of claim 1 , wherein an inner surface of the locking ring and an outer surface of the probe housing define complementary profiles for capture of the probe housing within the probe suspension assembly.

12. The probe holder assembly of claim 11 , wherein the complementary profiles of the exterior surface of the side wall of the probe housing and the interior surface of the locking ring of the probe suspension assembly define an arcuate profile.

13. The probe holder assembly of claim 12 , wherein the arcuate profile of the outer surface of the side wall is convex and the arcuate profile of the inner surface of the locking ring is concave.

14. The probe holder assembly of claim 12 , wherein the arcuate profile defines a spherical section.

15. The probe holder assembly of claim 12 , wherein the arcuate profiles cooperate to enable the probe housing to be oriented at a selected pitch angle relative to the ring axis.

16. The probe holder assembly of claim 1 , wherein the probe is an ultrasound probe.

17. The probe holder assembly of claim 16 , wherein the distal end of the probe housing includes an ultrasound lens for directing ultrasound waves emitted from the ultrasound probe.

18. The probe holder assembly of claim 17 , wherein the lens of the probe housing is injection molded.

19. The probe holder assembly of claim 17 or 18, wherein the lens comprises a polyamide material.

20. The probe holder assembly of claim 1 , wherein the probe housing includes a feedthrough for a wire of the probe.

21. The probe holder assembly of claim 20 , wherein the feedthrough is disposed adjacent a proximal end of the probe housing.

22. 1. A probe holder assembly comprising:

1. A probe suspension assembly for coupling to a probe, comprising: a locking ring defining a ring axis and collinear therewith, the locking ring having an inner surface configured to capture and secure the probe; one or more clasps for selectively gripping a plurality of ties, said one or more clasps being coupled to said locking ring; a probe suspension assembly including: A probe holder assembly comprising:

23. 23. The probe holder assembly of claim 22, wherein each of the one or more clasps includes an actuation mechanism having a lever that engages at least one of the plurality of ties, the lever configured for selective engagement and disengagement from at least one of the plurality of ties.

24. The probe holder assembly of claim 23 , wherein the lever is pivotally mounted to the actuation mechanism.

25. The probe holder assembly of claim 23 , wherein the probe suspension assembly includes a biasing element configured to hold the lever engaged with at least one of the plurality of ties.

26. The probe holder assembly of claim 23 , wherein the lever includes a nib that engages a serrated surface of at least one of the plurality of ties.

27. The probe holder assembly of claim 23 , wherein the lever clamps a serrated surface of at least one of the plurality of ties against a nib disposed on the actuation mechanism.

28. The probe holder assembly of claim 22, wherein the locking ring is bifurcated to define a first locking ring segment and a second locking ring segment.

29. 30. The probe holder assembly of claim 28, wherein the first locking ring segment and the second locking ring segment are pivotally connected to one another.

30. 29. The probe holder assembly of claim 28, wherein the probe is rotatable within the locking ring when the probe suspension assembly is in a partially closed configuration, and the probe is maintained in a fixed angular relationship within the locking ring when the probe suspension assembly is in a fully closed configuration.

31. 29. The probe holder assembly of claim 28, wherein the probe suspension assembly includes a capture extending from the first locking ring segment to the second locking ring segment to interlock the first and second locking ring segments in a fully closed configuration and statically secure the probe suspension assembly to the probe.

32. 32. The probe holder assembly of claim 31, wherein the catch includes a finger loop for manual actuation.

33. 32. The probe holder assembly of claim 31, wherein the capture is pivotally mounted to the first locking ring segment and selectively attachable to the second locking ring segment.

34. The probe holder assembly of claim 31 , wherein the capture portion includes a notch and a protrusion.

35. In a partially closed configuration, the notch engages a first alignment surface of the protrusion and defines a first maximum separation distance between a midpoint of the first locking ring segment and a midpoint of the second locking ring segment; in a fully closed configuration, the notch engages a second alignment surface of the protrusion to define a second maximum separation distance between a midpoint of the first locking ring segment and a midpoint of the second locking ring segment; the first maximum separation distance is greater than the second maximum separation distance; 35. The probe holder assembly of claim 34.

36. In the partially closed configuration, the probe is captured by and rotatable within the locking ring; In the fully closed configuration, the probe is captured by and in a fixed angular relationship with the locking ring.

36. The probe holder assembly of claim 35.

37. A probe holder assembly according to any one of claims 22 to 36, wherein the probe is an ultrasound probe.

38. 23. The probe holder assembly of claim 22, wherein the probe is selectively coupled to the locking ring in a twist locking arrangement.

39. 39. The probe holder assembly of claim 38, wherein the torsional locking arrangement includes a locking pin that mates with a locking groove.

40. The probe is housed in a probe housing; the probe housing includes the locking pin, and the locking ring defines the locking groove; 40. The probe holder assembly of claim 39.

41. 1. A probe holder assembly comprising:

1. An anchor assembly comprising: a compliant cover portion defining a location axis and defining an aperture concentric therewith; a plurality of tie anchors coupled to the compliant cover portion; a plurality of ties, each of the plurality of ties connected to a corresponding one of the plurality of tie anchors, the plurality of ties extending proximally from the plurality of tie anchors; an anchor assembly, A probe holder assembly comprising:

42. 42. The probe holder assembly of claim 41, wherein the compliant cover is of a mesh-like configuration.

43. 43. The probe holder assembly of claim 41 or 42, wherein the compliant cover is one of a fabric material, a polymer material, and a rubber material.

44. 42. The probe holder assembly of claim 41, wherein the ties of the plurality of ties are cable ties.

45. 42. The probe holder assembly of claim 41, wherein the plurality of tie anchors extend proximally through the compliant cover portion.

46. 42. The probe holder assembly of claim 41, wherein the plurality of tie anchors are coupled to a distal surface of the compliant cover portion.

47. 42. The probe holder assembly of claim 41, comprising an adhesive layer covering a distal surface of the compliant cover portion.

48. 48. The probe holder assembly of claim 47, wherein the adhesive layer covers distally facing surfaces of the plurality of tie anchors.

49. 42. The probe holder assembly of claim 41, comprising a probe suspension assembly for coupling to the anchor assembly, the probe suspension assembly including one or more clasps for selectively gripping a plurality of ties of the anchor assembly and applying and maintaining tension to the plurality of ties.

50. 50. The probe holder assembly of claim 49, wherein each of the one or more clasps includes an actuation mechanism having a lever that engages at least one of the plurality of ties, the lever configured for selective engagement and disengagement from at least one of the plurality of ties to freely position the probe suspension assembly in proximal and distal directions along the positioning axis.

51. 50. The probe holder assembly of claim 49, wherein the probe suspension assembly includes a locking ring for coupling to a probe, and the one or more clasps are coupled to the locking ring.

52. 1. A marker assembly comprising: a body portion defining a body axis extending through a proximal end and a distal end, the distal end of the body portion being mounted to the proximal end of the probe housing; a plurality of markers coupled to the body portion, the markers configured for viewing with a camera; a marker assembly including:

42. The probe holder assembly of claim 41, comprising:

53. 1. A probe holder assembly comprising: a probe housing for containing a probe, the probe housing including a proximal end and a distal end separated by a sidewall having an exterior surface; 1. A marker assembly comprising: a body portion defining a body axis extending through a proximal end and a distal end, the distal end of the body portion being mounted to the proximal end of the probe housing; a plurality of markers coupled to the body portion, the markers configured for viewing with a camera; a marker assembly including: Equipped with A probe holder assembly, wherein the probe housing and the marker assembly are configured for coupling in a fixed angular relationship about the body axis.

54. 54. The probe holder assembly of claim 53, wherein the coupler includes a plurality of dowel pins mounted on one of the probe housing and the marker assembly for insertion into corresponding openings defined on the other of the marker assembly and the probe housing.

55. 54. The probe holder assembly of claim 53, wherein the plurality of markers are configured for one of active emission and passive reflection.

56. 54. The probe holder assembly of claim 53, wherein the marker is configured for detection by an infrared camera.

57. 54. The probe holder assembly of claim 53, comprising a handle assembly having a distal end configured for selective coupling to the proximal end of the marker assembly.

58. 1. A probe holder assembly comprising:

1. A marker assembly comprising: a body portion defining a body axis extending through a proximal end and a distal end, the distal end of the body portion being mounted to the proximal end of the probe housing; a plurality of markers coupled to the body portion, the markers configured for viewing with a camera; a marker assembly including: a handle assembly having a distal end configured for selective coupling to a proximal end of the marker assembly; A probe holder assembly comprising:

59. the marker assembly includes a first connector at a proximal end of the body portion; the handle assembly includes a second connector at a distal end of the handle assembly; When fully engaged, the first connector and the second connector maintain the marker assembly and the handle assembly in a rotational relationship about a fixed axis.

59. The probe holder assembly of claim 58.

60. 60. The probe holder assembly of claim 59, wherein the first connector is integral with a body portion of the marker assembly.

61. 60. The probe holder assembly of claim 59, wherein the first connector and the second connector include polygonal interfaces for maintaining the rotational relationship.

62. 60. The probe holder assembly of claim 59, wherein the handle assembly includes a stem housed inside a guard portion, the stem configured to translate axially to couple the second connector to the first connector.

63. 63. A probe holder assembly according to any one of claims 59 to 62, wherein the first connector is female and the second connector is male.

64. 1. A method for positioning a probe on a patient for hands-free operation, comprising: providing a kit including an anchor assembly, a probe suspension assembly, and a probe housing; providing instructions on a tangible, non-transitory medium, the instructions comprising: adhesively coupling a compliant cover portion of the anchor assembly to an anatomical location of a patient; depressing opposing plunger mechanisms on the probe suspension assembly to freely position the probe housing along a positioning axis of the anchor assembly; releasing the opposing plunger mechanism on the probe suspension assembly when the probe housing is in desired contact with the patient's anatomical location and coupling the probe suspension assembly to the anchor assembly; Including steps and A method comprising:

65. The instructions provided in the step of providing instructions include: rotating the probe suspension assembly about a lateral axis of the probe suspension assembly during the step of depressing the opposing plunger mechanism to define a pitch angle of the probe housing relative to the positioning axis, the lateral axis being perpendicular to an actuation axis of the opposing plunger mechanism.

65. The method of claim 64, comprising:

66. The instructions provided in the step of providing instructions include: rotating the probe suspension assembly about a central axis of the probe suspension assembly during the step of depressing the opposing plunger mechanism to define a pitch angle of the probe housing relative to the positioning axis, the central axis being perpendicular to an actuation axis of the opposing plunger mechanism.

65. The method of claim 64, comprising:

67. The instructions provided in the step of providing instructions include: rotating the probe suspension assembly about a lateral axis of the probe suspension assembly during the step of depressing the opposing plunger mechanism to define a pitch angle of the probe housing relative to the positioning axis, the lateral axis being perpendicular to an actuation axis of the opposing plunger mechanism.

67. The method of claim 66, comprising:

68. 65. The method of claim 64, wherein releasing the opposing plunger mechanism comprises coupling to a plurality of ties and holding tension on the ties.

69. 65. The method of claim 64, wherein the probe housing is coupled to the probe suspension assembly in the kit providing step.

70. 65. The method of claim 64, wherein the instructions in the step of providing instructions include coupling the probe housing to the probe suspension assembly.

71. 1. A method for orienting a probe on a patient for hands-free operation, comprising: Providing a kit including a probe suspension assembly and a probe housing; providing instructions on a tangible, non-transitory medium, the instructions comprising: configuring a locking ring of the probe suspension assembly in a partially closed configuration; rotating the probe housing within the probe suspension assembly to a desired orientation; configuring the locking ring in a fully closed configuration to secure the probe housing in the desired orientation; Including steps and A method comprising:

72. rotating the probe housing includes defining a non-zero pitch angle between a probe axis of the probe housing and a ring axis of the probe suspension assembly; 72. The method of claim 71.

73. 72. The method of claim 71, comprising executing the instructions provided in the step of providing instructions.

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