Ultrasonic probe holding assembly

Abstract

The invention relates to a system and method for hand-free operation of an ultrasound probe. Pressure is maintained between the ultrasound probe and the subject without an externally applied force (e.g., without a hand, robotic arm, or other external force application). Flexible components that are largely conformable to the body contour are utilized to reduce deformation relative to rigid components used in conventional systems. Some embodiments provide a handle for probe orientation adjustment that can be selectively removed during hand-free operation to reduce gravitational torque. Other fabric forms include integrated marker assemblies, wireless information capabilities (e.g., RFID), and integrated ECG patches for tracking detector locations. Various embodiments of the present disclosure may include an ergonomic fastening arrangement that may provide mechanical advantages to facilitate decoupling and recoupling of the probe from an anchored mooring device. A full range of trim adjustment at the contact interface may be provided with or without the disclosed gimbal mount.

Description

[0001] Related Applications

[0002] This patent application claims the benefit of International Patent Application No. PCT / IB2022 / 058083 filed on August 29, 2022, the disclosure of which is hereby incorporated herein by reference in its entirety. Technical Field

[0003] The present application relates generally to ultrasound systems and more specifically to ultrasound probe assemblies. Background Art

[0004] Ultrasound imaging has many applications in modern medical procedures and treatments. A fundamental aspect of ultrasound imaging of internal areas of a human or animal subject is to apply appropriate forces at the contact interface between an associated ultrasound probe and the subject. Furthermore, in the context of modern clinical environments such as operating rooms, "hands-free" applications of ultrasound probes are often preferred, where the probe is held in the same position as the hand and the same pressure is applied as the hand, but these tasks do not need to be performed manually. Assemblies and techniques that enhance manual operation simulation in hands-free applications for a variety of applications would be welcome. Summary of the invention

[0005] Various embodiments of the present disclosure enable clinicians to safely and effectively perform extended hands-free ultrasound imaging in a patient with an ultrasound probe mounted to any body part and the patient in any position (e.g., lying down, sitting, standing). Systems and methods are disclosed for holding an ultrasound probe in place on a patient and for applying pressure between the ultrasound probe and a selected body part without externally applied force (e.g., without the need for hand, robotic arm, or other external force application). The geometry of components in the system that enhance these aspects is also disclosed.

[0006] The disclosed systems and techniques may be applied to any part of the body for diagnostic ultrasound imaging, ultrasound-based image guidance in surgery, or ultrasound-based therapy, 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-plane, 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 biplane B-mode ultrasound imaging for guidance in cardiac radiofrequency ablation therapy.

[0007] Relative to the rigid components of conventional systems, various embodiments of the present disclosure utilize flexible components that conform to the contours of the body to a large extent to reduce deformation. The disclosed system securely mounts the detector to the patient without the need for structures that create rigid pressure points near the contact interface and the accompanying image field deformation. The disclosed system can operate without the need for elastic straps, which would otherwise produce a strong radial force vector on the holder assembly. Some embodiments of the present disclosure enable the retention force of the detector to be independent of the pressure generated at the contact interface, provide a handle for detector orientation adjustment that can be selectively removed during hands-free operation to reduce gravitational torque, route the detector cable parallel to the contact interface, and / or deploy an integrated marker assembly for motion tracking of the detector position.

[0008] Various embodiments of the present disclosure may include an ergonomic snap-on arrangement that provides a mechanical advantage to facilitate uncoupling and recoupling of the probe from an anchored mooring. Some embodiments advantageously provide a gimbal structure for full range adjustment of the probe's pitch angle at the contact interface. The novel probe suspension assembly eliminates the need for the gimbal structure to contact the patient during operation. Other embodiments may achieve trim angle adjustment without the need for a gimbal structure.

[0009] Conventional systems that provide the ability to secure an ultrasound probe and track the movement of the ultrasound probe typically require multiple components. Such multi-component probe assemblies can be difficult to use because the components need to be arranged relative to each other and adjusted to scan the desired target zone. Many conventional multi-component probe systems require the operator to use both hands for handling, or require more than one operator to participate. Various embodiments of the disclosed system integrate the components to facilitate placement and adjustment of the components and hands-free operation.

[0010] "Hands-free" ultrasound imaging techniques are known in the art, which eliminate the need to handle the ultrasound probe during scanning. For example, see International Patent Application No. WO 2017 / 052363 by Tchang et al., U.S. Patent Application Publication No. 2020 / 0015780 by Geelen et al., and U.S. Patent Application Publication No. 2014 / 0107435 by Sharf et al. Such conventional hands-free systems have various common limitations and disadvantages, including that the mounting interface with the patient is rigid or rigidly supported, which may create small high pressure points on the skin, which may cause patient discomfort when mounted for a long time, and deform the subject contour in the presence of obese subjects. Other conventional systems and methods utilize an articulated mechanical or mechanical arm to apply force to the ultrasound probe, which occupies a considerable footprint around the contact interface of the probe. This increased footprint can limit the usefulness of ultrasound systems in applications where the position of the probe needs to be tracked in space (e.g., using an optical camera), medical personnel need to perform activities near the contact interface, and / or therapy / imaging machines need to operate near the contact interface.

[0011] The aforementioned functional aspects of various embodiments of the present disclosure address the limitations and disadvantages of conventional detector holder assemblies. The disclosed detector holder assembly is well suited for, but not limited to, use in non-invasive beam therapy systems, such as disclosed in International Patent Application Nos. WO 2022 / 136925 to Camps et al., WO 2021 / 094824 to Camps et al., and WO 2019 / 096943 to Garonna et al., which are owned by the owner of the present patent application.

[0012] Structurally, various embodiments of the disclosed probe holder assembly incorporate a probe housing for accommodating a probe, the probe housing including a proximal end and a distal end separated by a side wall having an exterior surface. An anchor assembly includes: a flexible cover portion defining an aperture for passing the distal end of the probe housing, the aperture defining a positioning axis and being co-linear with the positioning axis; an adhesive layer covering a distal face of the flexible cover portion; and a plurality of ties coupled to the flexible cover portion and extending from the flexible cover portion in a proximal direction. A probe suspension assembly for coupling to the probe housing and the anchor assembly includes: a locking ring defining a ring axis and being co-linear with the ring axis and having an interior surface configured to engage the exterior surface of the side wall of the probe housing to secure the locking ring to the probe housing; and one or more buckles for selectively grasping the plurality of ties of the anchor assembly to apply tension and maintain the plurality of ties in tension, the one or more buckles coupled to the locking ring. The detector suspension assembly is separated from the flexible cover portion by the plurality of ties.

[0013] In some embodiments, the anchor assembly includes a plurality of tether anchors attached to the flexible cover portion, each of the plurality of tether anchors being connected to a corresponding one of the plurality of tethers. The interior surface of the locking ring and the exterior surface of the probe housing may be configured to statically fasten the locking ring to the probe housing by friction. In some embodiments, the friction force has a magnitude that is selectively overcome by hand, such as by a torque applied to the probe housing around the ring axis, the torque exceeding a range of 1 Newton meter to 2.5 Newton meters, including 1 Newton meter and 2.5 Newton meters. The probe housing may be configured to couple with the locking ring of the probe suspension assembly near the distal end of the probe housing. In some embodiments, the one or more buckles may be adjusted along the plurality of tethers to limit the pitch angle of the ring axis relative to the positioning axis.

[0014] In some embodiments, the interior surface of the locking ring and the exterior surface of the detector housing define complementary profiles for capturing the detector housing within the detector suspension assembly. The complementary profiles of the exterior surface of the sidewall of the detector housing and the interior surface of the locking ring of the detector suspension assembly may define an arcuate profile. The arcuate profile of the exterior surface of the sidewall may be convex and the arcuate profile of the interior surface of the locking ring may be concave. In some embodiments, the arcuate profile defines a spherical segment. The arcuate profiles may cooperate to enable the detector housing to be oriented at a selected pitch angle relative to the ring axis.

[0015] 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 includes a polyamide material. The probe housing may include a feedthrough for a wire of the probe. In some embodiments, the feedthrough is disposed proximal to the proximal end of the probe housing.

[0016] In some embodiments, the probe holder assembly includes an information tag coupled to the flexible cover portion. In some embodiments, an electrocardiogram (ECG) sensor is coupled to the flexible cover portion.

[0017] Various embodiments of the present disclosure include a detector holder assembly, the detector holder assembly comprising: a detector suspension assembly for coupling with a detector, the detector suspension assembly comprising: a locking ring defining a ring axis and being co-linear with the ring axis and having an inner surface configured to capture and secure the detector; and one or more buckles for selectively grasping a plurality of ties, the one or more buckles coupled to the locking ring. The one or more buckles may include an actuation mechanism having a lever that engages at least one of the plurality of ties, the lever being configured to selectively disengage from the at least one of the plurality of ties. In some embodiments, the lever is pivotally mounted to the actuation mechanism.

[0018] In some embodiments, the detector suspension assembly includes a biasing element configured to maintain the lever engaged with the at least one of the plurality of tethers.

[0019] The lever may include a tip that engages a serrated surface of the at least one of the plurality of ties. In some embodiments, the lever secures the serrated surface of the at least one of the plurality of ties against a tip disposed on the actuation mechanism.

[0020] 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 can be pivotally connected to each other. In some embodiments, when the detector suspension assembly is in a partially closed configuration, the detector can rotate within the locking ring, and when the detector suspension assembly is in a fully closed configuration, the detector is maintained in a fixed angular relationship within the locking ring. The detector suspension assembly may include a lock buckle extending from the first locking ring segment to the second locking ring segment for interlocking the first locking ring segment with the second locking ring segment into a fully closed configuration, thereby statically fastening the detector suspension assembly to the detector. In some embodiments, the lock buckle includes a finger ring for manual actuation. The lock buckle is pivotally mounted to the first locking ring segment and can be selectively attached to the second locking ring segment. In some embodiments, the lock buckle includes a notch and a protrusion.

[0021] In some embodiments, in the partially closed configuration, the notch engages a first registration surface of the protrusion to define 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 may engage a second registration surface of the protrusion to define a second maximum separation distance between the midpoint of the first locking ring segment and the midpoint of the second locking ring segment. In some embodiments, the first maximum separation distance is greater than the second maximum separation distance. In the partially closed configuration, the probe may be captured by the locking ring and may rotate within the locking ring, while in the fully closed configuration, the probe may be captured by the locking ring and in a fixed angular relationship with the locking ring.

[0022] In some embodiments, the detector is selectively coupled to the locking ring in a twist-lock arrangement. The twist-lock arrangement may include a locking pin that mates with a locking groove. In some embodiments, the detector is housed in a detector housing. The detector housing may include the locking pin and the locking ring may define the locking groove.

[0023] Various embodiments of the present disclosure include a detector holder assembly, the detector holder assembly comprising an anchor assembly, the anchor assembly comprising: a flexible covering portion defining an orifice, the orifice defining a positioning axis and concentric about the positioning axis; a plurality of tether anchors coupled to the flexible covering portion; and a plurality of tethers, each tether connected to a corresponding one of the plurality of tether anchors, the plurality of tethers extending in a proximal direction from the plurality of tether anchors. The flexible covering may be a mesh configuration. The flexible covering may be one of a cloth material, a polymer material, and a rubber material. In some embodiments, the tethers of the plurality of tethers are cable ties. The plurality of tether anchors may extend through the flexible covering portion in a proximal direction. In some embodiments, the plurality of tether anchors are coupled to a distal face of the flexible covering portion.

[0024] The detector holder assembly may include an adhesive layer covering the distal surface of the flexible cover portion. The adhesive layer may cover the distal-facing surface of the multiple tether anchoring portions. In some embodiments, the detector holder assembly includes a detector suspension assembly, which is used to couple to the anchor assembly and includes one or more buckles for selectively grasping the multiple tethers of the anchor assembly to apply tension and maintain the multiple tethers in tension. Each of the one or more buckles includes an actuation mechanism having a lever, which engages at least one of the multiple tethers, and the lever is configured to selectively disengage from at least one of the multiple tethers, thereby freely positioning the detector suspension assembly in the proximal direction and the distal direction along the positioning axis.

[0025] In some embodiments, the probe suspension assembly includes a locking ring for coupling to the probe, the one or more snaps being coupled to the locking ring. The probe holder assembly may include a marker assembly, the 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 being configured to be viewed with a camera.

[0026] Various embodiments of the present disclosure include a detector holder assembly, the detector holder assembly comprising: a detector housing for accommodating a detector, the detector 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 end and the distal end, the distal end of the body portion being mounted to the proximal end of the detector housing; and a plurality of markers coupled to the body portion, the markers being configured to be viewed with a camera. The detector housing and the marker assembly may be configured to be coupled in a fixed angular relationship about the body axis. The coupling may include a plurality of locating pins mounted to one of the detector housing and the marker assembly for insertion into corresponding orifices defined on the other of the marker assembly and the detector housing. In some embodiments, the plurality of markers are configured for one of active emission and passive reflection, and may be configured to be detected by an infrared camera. In some embodiments, the probe holder assembly includes a handle assembly having a distal end configured for selective coupling to the proximal end of the marker assembly.

[0027] Various embodiments of the probe holder assembly disclosed herein include: 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; and a plurality of markers coupled to the body portion, the markers being configured to be viewed 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 located at the proximal end of the body portion. In some embodiments, the handle assembly includes a second connector located 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 fixed axial and rotational relationship. 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 to maintain the rotational relationship. In some embodiments, the handle assembly includes a stem portion housed within a guard portion, the stem portion configured to translate axially to couple the second connector to the first connector. The first connector may be female and the second connector may be male.

[0028] Various embodiments disclosed herein include 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; and providing instructions on a tangible non-transitory medium, the instructions including: adhesively coupling a flexible cover portion of the anchor assembly to an anatomical location of the patient; depressing an opposing plunger mechanism on the probe suspension assembly to freely position the probe housing along a positioning axis of the anchor assembly; and releasing the opposing plunger mechanism on the probe suspension assembly to couple the probe suspension assembly to the anchor assembly when the probe housing is in a desired contact condition with the anatomical location of the patient. The instructions provided in the step of providing instructions may include: during the step of depressing the opposing plunger mechanism, rotating the probe suspension assembly about a transverse axis of the probe suspension assembly to define a pitch angle of the probe housing relative to the positioning axis, the transverse axis being orthogonal to an actuation axis of the opposing plunger mechanism.

[0029] In some embodiments, the instructions provided in the step of providing instructions include: during the step of pressing the relative plunger mechanism, rotating the detector suspension assembly around a central axis of the detector suspension assembly to define a pitch angle of the detector housing relative to the positioning axis, the central axis being orthogonal to an actuation axis of the relative plunger mechanism. The instructions provided in the step of providing instructions may include: during the step of pressing the relative plunger mechanism, rotating the detector suspension assembly around a transverse axis of the detector suspension assembly to define the pitch angle of the detector housing relative to the positioning axis, the transverse axis being orthogonal to an actuation axis of the relative plunger mechanism. In some embodiments, the step of releasing the relative plunger mechanism includes coupling to a plurality of ties to keep the ties in tension. In the step of providing the kit, the detector housing may be coupled to the detector suspension assembly. In some embodiments, the instructions in the step of providing instructions include coupling the detector housing to the detector suspension assembly.

[0030] Various embodiments disclosed herein include a method of orienting a detector on a patient for hands-free operation, comprising: providing a kit including a detector suspension assembly and a detector housing; and providing instructions on a tangible non-transitory medium, the instructions including: configuring a locking ring of the detector suspension assembly to a partially closed configuration; rotating the detector housing within the detector suspension assembly to a desired orientation; and configuring the locking ring to a fully closed configuration to secure the detector housing in the desired orientation. The step of rotating the detector housing may include defining a non-zero pitch angle between a detector axis of the detector housing and a ring axis of the detector suspension assembly. In some embodiments, the method includes executing the instructions provided in the step of providing instructions. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 is a perspective view of a probe holder assembly according to an embodiment of the present disclosure;

[0032] Figure 2 According to the embodiment of the present disclosure Figure 1 A side elevation cross-sectional view of a detector holder assembly;

[0033] Figure 3 According to the embodiment of the present disclosure Figure 1 A front elevation cross-sectional view of a detector holder assembly;

[0034] Figure 4 According to an embodiment of the present disclosure, Figure 1 a proximal perspective view of a probe holder assembly kit of components of a probe holder assembly;

[0035] Figure 5 According to the embodiment of the present disclosure Figure 4 A distal perspective view of a detector holder assembly kit;

[0036] Figure 6 According to an embodiment of the present disclosure, Figure 1 a proximal perspective view of an anchor assembly of a probe holder assembly;

[0037] Figure 7 According to the embodiment of the present disclosure Figure 6 A distal perspective view of the anchor assembly;

[0038] Figure 8 According to the embodiment of the present disclosure Figure 6 A partially exploded view of an anchor assembly;

[0039] Fig. 9 According to an embodiment of the present disclosure, Figure 1a proximal end perspective view of a detector hanger assembly of a detector holder assembly of FIG. 1 with a closure removed to reveal a snap-fit ​​actuation mechanism;

[0040] Fig.10 According to the embodiment of the present disclosure Fig. 9 A far end perspective view of a detector suspension assembly;

[0041] Fig.11 is in a partially closed configuration according to an embodiment of the present disclosure Fig. 9 A plan cross-sectional view of a detector suspension assembly;

[0042] Fig.12 is in a fully closed configuration according to an embodiment of the present disclosure Fig.11 A plan cross-sectional view of a detector suspension assembly;

[0043] Fig.13 According to the embodiment of the present disclosure Fig.11 Small Figure X An enlarged view of the cross-sectional view at III;

[0044] Fig.14 According to the embodiment of the present disclosure Fig.12 Small Figure X An enlarged view of the cross-sectional view at IV;

[0045] Fig.15 According to the embodiment of the present disclosure, Figure 1 a plan view of an alternative detector suspension assembly for use with the detector holder assembly;

[0046] Fig.16 According to the embodiment of the present disclosure Fig. 9 An enlarged view of the snap-action actuation mechanism;

[0047] Fig.17 According to the embodiment of the present disclosure Fig.12 A cross-sectional view of the detector suspension assembly at plane XVII-XVII of FIG.

[0048] Fig.18 According to the embodiment of the present disclosure Fig.17 Small Figure X An enlarged cross-sectional view of the part at VIII;

[0049] Fig.19 is in an actuated state according to an embodiment of the present disclosure Fig.16 A plan view of a snap-on actuating mechanism;

[0050] Fig. 20 According to an embodiment of the present disclosure, Figure 1a proximal perspective view of a detector housing of a detector holder assembly;

[0051] Fig.21 According to the embodiment of the present disclosure Fig. 20 A distal perspective view of a detector housing;

[0052] Fig. 22 is a proximal perspective view of a probe housing having a right cylindrical outer surface according to an embodiment of the present disclosure;

[0053] Fig.23 is a device for coupling to an embodiment of the present disclosure Fig. 22 A cross-sectional view of a locking ring of a detector housing;

[0054] Fig.24 According to an embodiment of the present disclosure, Figure 1 a proximal perspective view of a marker assembly of a probe holder assembly;

[0055] Fig.25 According to the embodiment of the present disclosure Fig.24 a distal perspective view of a marker assembly;

[0056] Fig.26 According to the embodiment of the present disclosure Fig. 20 A front elevation view of a subassembly of a detector housing coupled to Fig.24 A marker assembly;

[0057] Fig. 27 According to the embodiment of the present disclosure Fig.26 A side elevation view of a subassembly of a detector housing and a marker assembly;

[0058] Fig.28 According to an embodiment of the present disclosure, Figure 1 a proximal perspective view of a handle assembly of a probe holder assembly;

[0059] Fig.29 According to the embodiment of the present disclosure Fig.28 a distal perspective view of a handle assembly;

[0060] Fig.30 According to the embodiment of the present disclosure Fig.28 A front elevation view of the handle assembly of with a portion of the housing removed;

[0061] Fig.31 According to the embodiment of the present disclosure Figure 1 A schematic elevational cross-sectional view of a first overall center of gravity of a rotatable component of a detector holder assembly;

[0062] Fig.32 According to an embodiment of the present disclosure, there is no handle assembly Fig.31 A schematic elevational cross-sectional view of a second overall center of gravity of a rotatable component of a detector holder assembly; and

[0063] Fig.33 is a partial elevational cross-sectional view of a detector holder assembly utilizing tether adjustment to achieve a pitch angle according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0064] refer to Figures 1 to 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 can be manufactured using only non-metallic materials such as polymers, rubber, and cloth.

[0065] exist Figure 1 The r-θ-z coordinate system is depicted in , which serves as the basis for nomenclature of directions and positions herein. "Axial" refers to the direction parallel to the z-coordinate, where "proximal" is in the positive direction along the z-coordinate and "distal" is in the negative direction along the z-coordinate, and "lateral" is the direction orthogonal to the z-coordinate. "Radial" refers to the direction along the r-coordinate, where the modifiers "inwardly" and "outwardly" are toward and away from the z-coordinate, respectively. "Tangential" refers to the direction congruent with the θ-coordinate.

[0066] refer to Figures 6 to 8 , the anchor assembly 32 is depicted in more detail according to an embodiment of the present disclosure. The anchor assembly 32 includes a flexible cover portion 60 defining an orifice 62, the orifice 62 defining a positioning axis 64 and concentric about the positioning axis. For purposes of illustration, the positioning axis 64 is assigned an origin O at the center of the orifice 62. A plurality of tether anchors 66 are coupled to the flexible cover portion 60. An adhesive layer 68 may cover a distal face 72 of the flexible cover portion 60 and may also cover a distal-facing surface 74 of the tether anchor 66. The anchor assembly 32 includes a plurality of tethers 76, each tether being connected to a corresponding one of the plurality of tether anchors 66. The plurality of tethers 76 extend in a proximal direction 78.

[0067] In some embodiments, the adhesive layer 68 is a sheet 70 having adhesive deposited on both sides and having a distal protective barrier (not depicted) that can be peeled off to mount the anchor assembly 32 to the patient. Alternatively, the adhesive layer 68 can be established by coating the distal face 72 of the flexible cover portion 60 when the anchor assembly 32 is mounted to the patient.

[0068] In some embodiments, the tether anchor 66 is coupled to the distal face 72 of the flexible cover portion 60. Each tether anchor 66 can define a receptacle 82 that receives a head portion 84 of a corresponding tether 76 attached thereto. The tether anchor 66 can extend through the flexible cover portion 60 in the proximal direction 78 and the distal direction 80, such as forming a through-aperture 86 in the flexible cover portion 60. The plurality of ties 76 can be cable ties (depicted), commonly referred to as ZIP-TIES. In some embodiments, the flexible cover portion 60 is a mesh configuration, such as a cloth material, a polymer material, or a rubber material.

[0069] In some embodiments, the information tag 88 is integrated into the anchor assembly 32. The information stored on the information tag 88 can be communicated to the wireless communication device 90 ( Figure 6 ) is received by a remote database. 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. This information may be encrypted, for example, on a barcode tag containing the baseline information or associated with the baseline information in a remote database. The remote database may be updated to include usage information, such as time and date of use, type of use (e.g., for actual or simulated treatment), and / or anonymous patient identification.

[0070] The information tag 88 may include local electronic storage capabilities that can accommodate both reading from and writing to it, such as provided by a radio frequency identification (RFID) chip or near field communication (NFC) tag and an appropriate wireless communication device 90. The read / write capability enables the local electronic storage to be updated to include usage information. In some embodiments, the storage capacity of the local electronic storage is in the range of 128 bits to 512 bits, inclusive.

[0071] In some embodiments, one or more electrocardiogram (ECG) sensors 92 are integrated into the anchor assembly 32 ( Figure 7 ). The cable assembly 94 can connect the sensor 92 to an ECG module 96 for processing signals from the ECG sensor 92. In some embodiments, leads from the cable assembly 94 are routed under or through the flexible cover portion 60 to connect to the ECG sensor 92. The ECG sensor 92 is arranged to be operatively coupled with the patient when the flexible cover portion 60 is adhered to the patient. In some embodiments, the number of ECG sensors 92 integrated into the anchor assembly 32 ranges from 1 to 6 sensors, including 1 and 6 sensors. Like the anchor assembly 32, the ECG sensor 92 can be disposable.

[0072] The ECG sensor 92 may be combined and 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 by the ECG module 96 or other processor via the cable assembly 94 to augment 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.

[0073] Functionally, the mechanical flexibility of the flexible cover portion 60 enables the adhesive layer 68 to be in full and uninterrupted contact over any anatomical contour, thereby enhancing the strength of the engagement with the patient. Relative to a rigid mounting interface, the flexibility of the cover portion 60 reduces deformation of anatomical contours to improve fine pressure management. The enhanced engagement also enables the anchor assembly to remain fixed to the patient over an extended period of time. The presence of the flexible cover portion 60 without the remaining components of the system enables visualization of the ultrasound probe position on a computed tomography (CT) scan in the absence of an ultrasound probe, thereby eliminating potential artifacts on the CT image caused by the ultrasound probe. The flexible cover portion 60 can serve as a template for easily marking the patient's skin for later repositioning or reinstalling the probe holder assembly 30.

[0074] The information tag 88 facilitates historical tracking of the anchor assembly 32. In one example, the anchor assembly 32 is removed from the package and the information tag 88 is read by the wireless communication device 90. For example, the usage information can be updated in a remote memory or, for the information tag 88 so equipped, on a local memory. For example, the usage information can facilitate ensuring that the anchor assembly 32 is utilized or not used for different patients in an appropriate disposable manner. The information tag 88 can also be used to track the history of other components of the probe holder assembly 30.

[0075] refer to Fig. 9 and 10 , a detector suspension assembly 34 is depicted according to an embodiment of the present disclosure. The detector suspension assembly 34 includes a locking ring 102, which defines a ring axis 104 and is colinear with the ring axis. The locking ring 102 includes an inner surface 106 that faces radially inwardly to the ring axis 104. The detector suspension assembly 34 also includes one or more buckles 108 coupled to the locking ring 102. In some embodiments, two such buckles 108 are disposed on opposite sides of the locking ring 102. The opposing buckles 108 can be centered on a central axis 112 of the detector suspension assembly 34 that extends perpendicular to the ring axis 104. The transverse axis 114 of the detector suspension assembly 34 can also be defined as being perpendicular to both the ring axis 104 and the central axis 112.

[0076] The locking ring 102 may be a forked locking ring 102a defining two locking ring segments 102a′ and 102a″. Each of the locking ring segments 102a′ and 102a″ may be coupled to a pivot structure 122, which extends from the locking ring segments 102a′ and 102a″ for rotation about a pivot axis 124 defined, for example, by a pivot pin 126. The locking ring segments 102a′ and 102a″ may include free ends 128 opposite to the respective pivot structures 122, which may be tangentially separated and selectively coupled to each other.

[0077] Herein, the detector holder assembly 30, the detector suspension assembly 34, the locking ring 102 and its inner surface 106, and the detector housing 36 and its outer surface 270 are collectively and generically referred to by their corresponding reference symbols. Specific or individual embodiments of these components and properties are referenced with letter suffixes (e.g., "detector suspension assembly 34a").

[0078] refer to Figures 11 to 14 , various aspects of the bifurcated locking ring 102a of the detector suspension assembly 34a are further described according to embodiments of the present disclosure. In some embodiments, the free ends 128 are selectively coupled to each other using a latch 140. The latch 140 can be pivotally coupled to one of the locking ring segments 102a′, 102a″, for example, using a pivot pin 142. In some embodiments, the latch 140 is pivotally mounted to the first locking ring segment 102a′ and can be selectively attached to the second locking ring segment 102a″. The latch 140 may include a recess 144 and a protrusion 146. In some embodiments, the latch 140 is coupled to a finger ring 148 for actuation.

[0079] In some embodiments, the notch 144 and the protrusion 146 of the lock buckle 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 registration surface 162 of the protrusion 146 to define a first maximum separation distance D1 between the midpoint 164 of the first locking ring segment 102a′ and the midpoint 166 of the second locking ring segment 102a″. In the fully closed configuration 180 ( Fig.12 ), the recess 144 engages the second registration surface 182 of the protrusion 146 to define a second maximum separation distance D2 between the midpoint 164 of the first locking ring segment 102a′ and the midpoint 166 of the second locking ring segment 102a″. In some embodiments, the protrusion 146 includes a transition slope 186 between the first registration surface 162 and the second registration surface 182. The first maximum separation distance D1 of the partially closed configuration 160 is greater than the second maximum separation distance D2 of the fully closed configuration 180.

[0080] In operation, the detector 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 can be sized to enable the detector housing 36a to rotate with minimal resistance while laterally constraining the detector housing 36a to prevent substantial radial translation within the locking ring segments 102a′ and 102a″. In the fully closed configuration 180, the second maximum separation distance D2 can be configured to securely clamp the detector housing 36a between the locking ring segments 102a′ and 102a″, thereby maintaining the detector housing 36a in a fixed angular relationship relative to the detector suspension assembly 34a.

[0081] refer to Fig.15 , a detector suspension assembly 34b having a continuous locking ring 102b is depicted according to an embodiment of the present disclosure. The detector suspension assembly 34b may include several of the same components and attributes as the detector suspension assembly 34a, some of which are indicated by the same reference symbols. In some embodiments, the continuous locking ring 102b has sufficient elasticity and resilience to allow the outer surface of the detector housing 36a (e.g., Fig. 20 and 21 The structure on the outer surface 270, 270a of the detector housing 36a can protrude into the continuous locking ring 102b and thereafter maintain sufficient contact to statically fasten the detector housing 36a to the detector suspension assembly 34b by friction. The friction force can have a magnitude that can be selectively overcome by hand. In some embodiments, the friction force is overcome by a torsional force applied to the housing 36 about the co-linear ring axis 104 and the detector axis 268, the torsional force exceeding a value in the range of 1 Newton meter to 2.5 Newton meters (including 1 Newton meter and 2.5 Newton meters).

[0082] refer to Figures 16 to 19 , various aspects of the buckle 108 of the detector suspension assembly 34 are further described according to embodiments of the present disclosure. Each buckle 108 includes an actuation mechanism 200 having a plunger 202, which is coupled to a tip 204 for engaging a locking structure 206 defined by a respective one of the plurality of ties 76. The tip 204 may be a pawl 208 that engages a notch 212 formed on the tether 76. In some embodiments, the locking structure 206 includes a plurality of notches 212 to define a serrated profile 214, such as defined on commercially available ZIP-TIES. Although not depicted, alternative locking structures 206 may be readily implemented by a person skilled in the art in view of the teachings of the present disclosure (e.g., through-apertures, perforations, high friction surfaces), and are considered to be within the scope of the present disclosure.

[0083] The actuation mechanism 200 may be mounted to a bracket 220 that is attached to the locking ring 102. The bracket 220 may extend radially outward from the locking ring 102. In some embodiments, the actuation mechanism 200 is housed in an enclosure 222 that is coupled to the bracket 220. The bracket 220 may be configured to receive one or more of the plurality of tethers 76, such as via a through passage 224 defined by the bracket 220, the enclosure 222, or both, to enable the tethers 76 to pass therethrough.

[0084] In some embodiments, the actuation mechanism 200 includes a biasing element 226 that biases the tip 204 into engagement with the tether 76. For example, the tip 204 can be disposed on a lever 228 coupled to the plunger 202 (depicted). The lever 228 can be pivotally coupled to the bracket 220, such as with a pivot pin 232.

[0085] The biasing element 226 may include a bend 242 that is integral or unitary with the plunger 202 (depicted). Although not depicted herein, other biasing elements may be incorporated by one of ordinary skill in the art in view of the teachings of the present disclosure (e.g., coil springs, spring arms, leaf springs, elastomeric blocks) and are considered within the scope of the present disclosure.

[0086] In the depicted embodiment, the buckle 108 is configured to be engaged with a respective one of the plurality of laces 76 by default and released upon actuation of the actuation mechanism 200. Alternatively, the actuation mechanism 200 may be arranged to be in a disengaged configuration by default (not depicted) and to engage and secure the tip 204 to the lace 76 upon actuation. Also in the depicted embodiment, the tip 204 is disposed on a lever 228. Alternatively or in addition, the tip 204 may be secured to a bracket 220 rather than a lever 228, and the lace 76 arranged such that the locking structure 206 of the lace 76 engages the bracket 220 (i.e., the tip 204 on the bracket 220) for buckling.

[0087] In operation, the biasing element 226 maintains the locking structure 206 ( Fig.18 ) between the lace 76. Applying an actuation force F to press the plunger 202 radially inwardly overcomes the bias of the plunger 202 and disengages the tip 204 from the lace 76 ( Fig.19 ). In the depicted embodiment, application of the actuation force F causes the lever 228 to rotate about the pivot pin 232 and away from the tether 76, thereby releasing the tip 204 from the tether 76 and, accordingly, releasing the probe suspension assembly 34 from the anchor assembly 32.

[0088] For embodiments having snaps 108 on opposite sides of the locking ring 102, the plungers 202 can be aligned along the actuation axis 203 so that the opposing actuation forces F cancel each other (eg, Fig.15), thereby maintaining the probe suspension assembly 34 in balance above the anchor assembly 32 during actuation by the operator. In some embodiments, the actuation axis 203 is parallel to the central axis 112 of the probe suspension assembly 34a and may be colinear with the central axis. The disengagement of the tip 204 from the tether 76 enables the probe suspension assembly 34 to be axially translated in the proximal direction 78 and the distal direction 80 along the positioning axis 64, wherein the tether 76 passes through the probe suspension assembly 34. When the probe suspension assembly 34 is in the desired axial position 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 causing the lever 228 to pivot about the pivot pin 232 to restore the engagement between the tip 204 and the locking structure 206 of the tether 76.

[0089] Functionally, the probe suspension assembly 34 cooperates with the anchor assembly 32 to apply an axial force to the patient during hands-free operation. The hands-free feature reduces the number of components required to obtain high-quality ultrasound (e.g., by eliminating the handle assembly 42 in the hands-free mode). Repeated bidirectional positioning of the probe suspension assembly 34 along the positioning axis 64 controls the pressure at the interface of the probe housing 36 and the patient and the accompanying skin deformation, which can be adjusted to enhance ultrasound image quality.

[0090] refer to Fig. 20 and 21 And refer again Figure 2 and 3 , a probe housing 36 for accommodating 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 a probe axis 268 and are concentric about the probe axis. An exterior surface 270 of the probe housing 36 is configured to engage an interior surface 106 of the locking ring 102. The probe housing 36 may be configured to couple with the locking ring 102 of the probe suspension assembly 34 proximate the distal end 264 of the probe housing 36. In some embodiments, the proximal end 262 includes one or more locating pins 272 extending axially in the proximal direction 78 and may include a screw hole 274 configured to receive a fastener (not depicted).

[0091] The interior surface 106a and the exterior surface 270a can define complementary profiles for capturing the detector housing 36a within the locking ring 102 of the detector suspension assembly 34. In some embodiments, the profile of the exterior surface 270a of the sidewall 266 is convex and the profile of the interior surface 106a of the locking ring 102 is concave (depicted). The complementary profiles of the exterior surface 270a and the interior surface 106a can define an arcuate profile. In some embodiments, the exterior surface 270a and the interior surface 106a define a spherical segment.

[0092] In some embodiments, the distal end 264 of the probe housing 36 includes an ultrasonic lens 276 for guiding ultrasonic waves emitted from the ultrasonic probe. The ultrasonic lens 276 may include a polyamide material. In some embodiments, the ultrasonic lens 276 is formed by an injection molding process. The probe housing 36 may include a feedthrough 278 for passing the wires and cables of the ultrasonic probe. In some embodiments, the feedthrough 278 faces radially outward and may be disposed proximal to the proximal end 262 of the probe housing 36.

[0093] 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 applying external forces. With the probe housing 36 in contact with the patient, the probe housing 36 is enabled to rotate substantially freely about a fixed point on the patient. For embodiments in which the exterior surface 270 and the interior surface 106 (e.g., the exterior surface 270a and the interior surface 106a) define complementary segments of a sphere or other arcuate shape, the probe suspension assembly 34 (e.g., 34a) and the probe housing 36 (e.g., 36a) act as a universal joint for orienting the probe housing at an arbitrary pitch angle φ (φ) about the ring axis 104. Fig.31 and 32 ). The desired position and rotational orientation of the probe housing 36 is secured in place for hands-free ultrasound imaging for extended periods of time. The use of non-metallic materials for components other than the ultrasound probe reduces metal artifacts in CT imaging. The location of the feedthrough 278 enables the ultrasound probe's wires and cables to be a distance from the patient's skin, further reducing metal artifacts in CT images. The configuration of the proximal end 262 of the probe housing 36 enables components (e.g., the marker assembly 38) to be securely and accurately secured to the probe housing 36.

[0094] refer to Fig. 22 and 23 , a detector housing 36c and a detector 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 detector housing 36a and the detector suspension assemblies 34a, 34b, some of which are identified by identically labeled reference symbols. The distinguishing aspects of the locking ring 102c of the detector housing 36c and the suspension assembly 34c are the right cylindrical outer surface 270c and the inner surface 106c. The locking ring 102c may be a bifurcated structure, such as depicted for the detector suspension assembly 34a, or a continuous structure, such as depicted for the detector suspension assembly 34b.

[0095] In some embodiments, another distinguishing aspect of the detector housing 36c and the detector suspension assembly 34c is the locking pin 282 and the locking groove 284. The locking pin 282 may extend radially outward from the exterior surface 270c of the detector housing 36c (depicted), wherein the locking groove 284 is defined by the interior surface 106c of the locking ring 102c (depicted) and is sized to receive the locking pin 282. Alternatively, in some embodiments (not depicted), the pin structure 282 and the groove structure 284 may be disposed on the locking ring 102c and the detector housing 36c, respectively, instead.

[0096] In some embodiments, the locking groove 284 defines an entrance 286 and includes a cam structure 288 leading to a pawl 290. The cam structure 288 may include a lead-in structure 292 located at the entrance 286. The cam structure 288 may define an axial slide 294 that leads to a tangential slide 296 (depicted) that terminates at the pawl 290. Alternatively, the cam structure 288 may define a spiral shape around the ring axis 104 leading to the pawl 290 (not depicted).

[0097] exist Fig. 22 and 23 Only one locking pin 282 and locking groove 284 are depicted in the drawings. However, multiple such locking pins 282 and locking grooves 284 are contemplated. In some embodiments, multiple locking pins 282 and locking grooves 284 are evenly distributed around the ring axis 104 to achieve multiple rotational orientations of the detector housing 36c within the detector suspension assembly 34c. Alternatively, multiple locking pins 282 and locking grooves 284 may be unevenly distributed around the ring axis 104 for keying the detector housing 36c and the detector suspension assembly 34c relative to each other in a fixed rotational orientation.

[0098] During assembly, the probe housing 36c and the probe suspension assembly 34c are aligned so that their respective axes 269 and 104 are colinear and rotated so that the locking pin 282 is aligned with the entrance 286 of the locking groove 284. The probe housing 36c is inserted into the locking ring 102c so that the locking pin 282 enters the locking groove 284. The locking pin 282 can be guided into the pawl 290 by the cam structure 288 using the translation and torsional action between the probe housing 36c and the locking ring 102c.

[0099] The positioning of the entrance 286 of the locking groove 284 can be arranged to accommodate the feed-through device 278 of the detector housing 36c. That is, for embodiments in which the locking groove 284 is defined by the locking ring 102c ( Fig.23 ), the inlet 286 will face the direction of the feed-through 278 (i.e., in Fig.23For embodiments where the locking recess 284 is defined by the probe housing 36 (not depicted), the inlet 286 will be facing away from the feed-through 278 (i.e., in the proximal direction of Fig. 22 By these arrangements, the probe housing 36c can be seated within the locking ring 102c without interference from the feed-through device 278.

[0100] Functionally, the probe housing 36c and the probe suspension assembly 34c define a twist lock arrangement similar to a bayonet connector, wherein the locking pin 282 cooperates with the locking groove 284 to secure the probe housing 36c to the probe suspension assembly 34c. The locking pin 282 is inserted into the locking groove 284 and guided to the pawl 290 by the cam structure 288. The locking pin 282 is held in registration within the pawl 290 by an axial force (for example, a reaction force to the probe housing 36c contacting the patient). The introduction structure 292 acts to guide the locking pin 282 into the locking groove 284.

[0101] Embodiments that do not include the locking pin 282 and the locking groove 284 are also contemplated, wherein the detector housing 36c is held securely within the detector suspension assembly 34c by a clamping force applied by the locking ring 102c (e.g., in a bifurcated ring arrangement) or by friction between the outer surface 270c of the detector housing 36c and the inner surface 106c of the locking ring 102c (e.g., in a continuous ring arrangement). The friction force may have a magnitude that can be selectively overcome by hand. In some embodiments, the friction force is overcome by a torsional force applied to the detector housing 36c about the colinear ring axis 104 and the detector axis 268, the torsional force exceeding a value in the range of 1 Newton meter to 2.5 Newton meters (including 1 Newton meter and 2.5 Newton meters).

[0102] refer to Figures 24 to 27 And refer again Figure 2 and 3 , a marker assembly 38 is depicted according to an embodiment of the present disclosure. The marker assembly 38 includes a body portion 302 that defines a body axis 304 extending through a proximal end 306 and a distal end 308, the distal end 308 of the body portion 302 being configured for mounting to the proximal end 262 of the probe housing 36. A plurality of markers 322 are coupled to the body portion 306, the markers 322 being configured for viewing with a camera (not depicted). In some embodiments, the body portion 302 defines or includes a body connector 324 accessible from the proximal end 306. In the depicted embodiment, the body connector 324 presents a flange portion 326 for coupling with the handle assembly 42.

[0103] 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 specified by the tracking system manufacturer. An example of such a protocol may be found in a tracking system for a 1000-meter ... The Polaris Tool Design Guide, 6th edition, 2018, is available at http: / / www.polaristool.com / products / polaris-tool-design-guide.

[0104] The detector housing 36 and the marker assembly 38 are configured to couple in a fixed angular relationship about the body axis 304 and maintain the body axis 304 of the marker assembly 38 and the detector axis 268 of the detector housing 36 in a substantially co-linear arrangement. The distal end 308 of the body portion 302 may define a locating aperture 328 configured to receive the locating pin 272 of the detector housing 36. Alternatively, the marker assembly 38 may include a locating pin extending distally and received by the locating aperture defined by the detector housing 36 (not depicted). In some embodiments, the distal end 308 of the body portion 302 defines a through aperture 330 for receiving a fastener (not depicted), which, when assembled, is aligned with the screw hole 274 of the detector housing 36.

[0105] Functionally, the marker assembly 38 enables placement of active or passive markers 322 for use in tracking the position of the probe housing 36 using a camera. The placement of the markers 322 further enables tracking the position of the probe housing 36 from a variety of different tracker positions.

[0106] refer to Figures 28 to 30 And refer again Figure 2 and 3 , a handle assembly 42 is depicted according to an embodiment of the present disclosure. The handle assembly 42 includes a proximal end 342 and a distal end 344 separated by a shell 346. The proximal end 342, the distal end 344 and the shell 346 define a handle axis 348 and are concentric about the handle axis. The shell 346 may include two shell portions 346′ and 346″ that are joined together to form an internal cavity 362 of the shell 346. One or more bosses 364 may extend from the shell 346 into the internal cavity 362 to receive fasteners (not depicted) for fastening the shell portion 346′ to the shell portion 346″.

[0107] 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 and extending into the distal end 344. The handle plunger 368 may include a push button 382 that is accessible from the proximal end 342 and can be actuated by, for example, the thumb or palm of an operator. In some embodiments, the handle connector 366 includes a connector feature 384 that depends from the handle plunger 368 and extends to or through the distal end 344 of the handle assembly 42, the feature 384 being configured to engage the body connector 324 of the marker assembly 38. The handle plunger 368 may include a stopper 386 that engages the housing 346 to prevent the handle plunger 368 from over-extending in either the proximal direction 78 or the distal direction 80 within the housing 346 (eg, by defining an opening 388 that engages the boss 364 on the handle plunger 368 ).

[0108] The handle connector 366 may include a guide 390 for alignment and stability of the connection with the marker assembly 38. In some embodiments, the handle plunger 368 is coupled to the housing 346 with 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 feature 384 radially inward (i.e., toward the handle axis 348) when actuated in the distal direction 80 within the housing 346, such as by interaction between a ramp 394 structure on the handle plunger 368 and a deflector shoulder 396 coupled to the interior of the housing 346.

[0109] When assembled, the probe housing 36 and the marker assembly 38 are fastened to each other, for example, by a press fit between a plurality of locating pins 272 and corresponding locating apertures 328. In some embodiments, a fastener (not depicted) is inserted into a through aperture 330 at the distal end 308 of the body portion 302 of the marker assembly 38 and screwed into a screw hole 274 at the proximal end 262 of the probe housing 36, thereby fastening the marker assembly 38 to the probe housing 36. In some embodiments, the coupling of the probe housing 36 and the marker assembly 38 includes a press 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.

[0110] The detector housing 36 is coupled to the detector suspension assembly 34. For the detector suspension assembly 34a, the detector housing 36 is coupled to the locking ring 102 by opening the bifurcated locking ring 102a and securing the detector housing 36 in the partially closed configuration 160 or the fully closed configuration 180. For the detector suspension assembly 34b, the detector housing 36 is pressed into the continuous locking ring 102b to snap into place. For example, the plurality of ties 76 are fed through the through-channel 224 of the detector suspension assembly 34 by pressing the plunger 202 of the detector suspension assembly 34 radially inward. The detector suspension assembly 34 is coupled to the plurality of ties 76 at any axial position along the positioning axis 64, for example, by releasing the plunger 202.

[0111] The handle assembly 42 is coupled to the marker assembly 38, for example, by aligning the guide 390 at the distal end 344 of the handle assembly 42 with a complementary structure on the marker assembly 38 and inserting the connector feature 384 of the manual plunger 368 into the handle connector 366 located at the proximal end 306 of the marker assembly 38. The handle assembly 42 is secured to the marker assembly 38, for example, by a clamping action of the connector feature 384 mating to the body connector 324. The connection can be maintained by a proximal bias applied by the biasing element 392.

[0112] In operation, the anchor assembly 32 is adhesively coupled to the patient at the desired anatomical position. Ultrasound gel (not depicted) may be applied to the patient within the orifice 62 of the flexible cover portion 60 to enhance ultrasound coupling. In some embodiments, the axial positioning procedure includes releasing the probe suspension assembly 34 from the anchor assembly 32 to allow the probe suspension assembly 34 to freely and repeatedly translate along the positioning axis 64 in both the proximal direction 78 and the distal direction 80. 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 position relative to the anchor assembly 32. Determining the desired axial position may involve such free and repeated positioning and intermittent locking of the probe suspension assembly 34 to the anchor assembly 32 to check ultrasound image quality without applying external forces (i.e., in a "hands-free" state). In the hands-free state, a plurality of laces 76 are in a tensioned state, thereby maintaining the force applied by the probe housing 36 on the patient.

[0113] As explained above, for the depicted embodiment, releasing the detector suspension assembly 34 from the tether 76 of the anchor assembly 32 to freely translate along the positioning axis 64 is performed by pressing the plunger 202 radially inward toward the positioning axis 64. This aspect of the present disclosure is non-limiting. An operator or a person skilled in the art may configure or operate a detector holder assembly 30 mutatis mutandis in view of the teachings of the present disclosure, the detector holder assembly enabling free and repeated positioning without actuating the plunger and locking the detector suspension assembly 34 to the anchor assembly 32 by actuating the plunger or similar structure. As such, the assembly and operating procedures are not limited to the depicted embodiment.

[0114] refer to Fig.31 and 32 , pitch and rotation adjustment of the probe holder assembly 30a is depicted according to an embodiment of the present disclosure. For embodiments utilizing a probe housing 36a and a probe suspension assembly 34a or 34b, the probe housing 36a can be rotated within the locking ring 102a, 102b and about the ring axis 104 and also oriented at a pitch angle φ defined between the ring axis 104 and the probe axis 268. The axial position of the probe suspension assembly 34a, 34b relative to the anchor assembly 32 can remain fixed during pitch and rotation adjustment. During pitch and rotation adjustment, the ring axis 104 and the positioning axis 64 remain in a fixed relationship to each other, and the probe axis 268, the body axis 304, and the handle axis 348 also remain in a fixed relationship to each other.

[0115] For the detector suspension assembly 34a, by configuring the bifurcated locking ring 102a into the partially closed configuration 160 ( Fig.11 and 13 ) to make adjustments. An operator can use the finger ring 148 of the detector suspension assembly 34a to manipulate the bifurcated locking ring 102a into the partially closed configuration 160. In the partially closed configuration 160, the detector housing 36 and marker assembly 38 can rotate and tilt about the ring axis 104 with minimal resistance.

[0116] For the probe suspension assembly 34b, rotational adjustment of the probe housing 36a is performed by overcoming the friction 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 rotation orientation of the probe housing 36a is achieved, the operator simply releases the grip on the handle portion. The probe housing 36a is maintained in the released rotational orientation by the friction on the inner surface 106a and the outer surface 270a.

[0117] Once the desired pitch and roll adjustments have been made, the forked locking ring 102a is configured into a fully closed configuration 180 ( Fig.12 and 14 ) to secure the probe housing 36 in the desired rotational orientation. The operator can use the finger ring 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 the marker assembly 38 are securely held in the desired rotational orientation by the bifurcated locking ring 102a.

[0118] After the probe housing 36 has been configured in a desired position and orientation for operation, the handle assembly 42 can be removed. The handle connector 366 of the handle assembly 42 is decoupled from the body connector 324 of the marker assembly 38 and the handle assembly 42 is disengaged. In the depicted embodiment, the decoupling of the handle connector 366 is accomplished by pressing the push button 382 into the housing 346, thereby causing the ramp 394 of the handle plunger 368 to engage the deflector shoulder 396 of the housing 346, thereby deflecting the connector feature 384 radially inwardly 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.

[0119] Any combination of the disclosed probe housing 36, marker assembly 38, and handle assembly 42 is referred to herein as a rotatable assembly 398, wherein "rotatable" refers to the ability to rotate about and tilt relative to the locating axis 64. Fig.31 and 32 , the 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 the center of gravity. In general, the rotatable components 398 present for a given configuration can be characterized as establishing a total center of gravity CG, where "total" refers to a given combination of rotatable components 398. The total center of gravity CG is further characterized as being located at the moment arm MA from the origin O (i.e., the center of the orifice 62 of the flexible cover portion 60) of the positioning axis 64. The total mass M is defined as the sum of the masses of the rotatable components 398 and is characterized as being located at the total center of gravity CG. 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 cause a moment about the origin O that is proportional to the product of the total mass M and the moment arm MA.

[0120] To facilitate axial positioning and rotational orientation procedures, the handle assembly 42 may be part of a rotatable assembly 398, thereby establishing a first overall center of gravity CG1 ( Fig.31). The first total center of gravity CG1 is located at a first moment arm MA1 from the origin O of the positioning axis 64 (i.e., the center of the orifice 62 of the flexible cover portion 60). The total mass M1 is the sum of the masses of the rotatable components 398 (the mass of the probe housing 36, the marker assembly 38, and the handle assembly 42). For applications where the positioning axis 64 and the ring axis 104 are not aligned with the gravity vector G, the gravity vector will cause a moment about the origin O that is proportional to the first total mass M1 and the first moment arm MA1.

[0121] Once the probe housing 36 is secured in the desired position and orientation, the handle assembly 42 may be removed. After removal, the second overall center of gravity CG2 and the second overall mass M2 are defined at the second moment arm MA2 ( Fig.32 ). Since 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. In this way, any moment about the origin O is reduced by removing the handle assembly 42.

[0122] Functionally, the handle assembly 42 enhances manipulation of the probe housing 36 with one hand to adjust the ultrasound image. After the handle assembly 42 is removed, the reduced mass M2 and the reduced moment arm MA2 about the origin O of the positioning axis 64 reduce the moment counteracted by the anchor assembly 32 and reduce the concomitant deformation of the anatomical structure near the contact area of ​​the probe housing 36.

[0123] The various assembly and operation procedures described above are not limited in order. That is, the steps performed in the assembly and operation procedures can be mixed. For example, the operation steps for mounting the anchor assembly 32 to the patient can occur before the step of coupling the detector suspension assembly 34 to the plurality of ties 76. In another example, the steps of the rotation adjustment procedure of the detector housing 36 can be mixed with or incorporated with the steps of the axial positioning procedure of the detector housing 36.

[0124] refer to Fig.33 , a probe holder assembly 30c is depicted according to an embodiment of the present disclosure that utilizes tether connection length adjustment to achieve a pitch angle φ. The probe holder assembly 30c includes many of the same components and attributes as the probe holder assembly 30a, which are identified by identically labeled reference symbols. The difference in the probe holder assembly 30c is the use of a probe suspension assembly 34c having right cylindrical surfaces 106c and 270c. As such, the probe holder assembly 30c does not include a universal joint structure for adjusting the pitch angle φ. Instead, the pitch angle φ is established by connecting to various tethers 76 at different axial positions L along the positioning axis 64.

[0125] Lace-up 76 Figure 6 1, 12 and 13. In the drawings, the laces 76.1, 76.2, 76.3 and 76.4 are individually identified, wherein the laces 76.1 and 76.3 and the laces 76.2 and 76.4 are laterally spaced apart (i.e., spaced apart parallel to the transverse axis 114). Fig.33 , the connection with the tethers 76.1 and 76.2 at different axial positions L1 and L2, respectively, is illustrated. Thus, the detector suspension assembly 34c is tilted between the tethers 76.1 and 76.2 to define a pitch angle φ of the ring axis 104 relative to the positioning axis 64. This is consistent with Fig.31 and 32 In contrast to the universal joint structure arrangement, Fig.31 and 32 , a pitch angle φ is defined between the ring axis 104 and the probe axis 268 .

[0126] In some embodiments, a buckle 108 is used to access different axial positions L1 and L2. Fig.33 Not visible in the cross-section view, but Figures 17 to 19 1 and 2. The operation of the plunger 202 is depicted at 34c. In the depicted embodiment, the plunger 202 is actuated with a relative actuation force F and the detector suspension assembly 34c is rotated about its transverse axis 114. Actuation of the plunger 202 releases the buckle 108 from the tether 76, allowing the buckle 108 to rotate substantially freely about the transverse axis 114 as it slides along the tether 76. At the desired pitch angle φ, the plunger 202 is released or deactivated, causing the buckle 108 to re-engage the tether 76 at different axial positions L1 and L2, thereby maintaining the pitch angle φ.

[0127] In some embodiments, alternatively or additionally, during release of the buckle 108, the detector suspension assembly 34c can be rotated about its central axis 112. Thereby, the laterally adjacent ties 76.1 and 76.3 and the laterally adjacent ties 76.2 and 76.4 (in Figure 6 The rotation about the central axis 112 results in the pitch angle φ being defined at a plane that is not parallel to the central axis 112 .

[0128] During rotation of the detector suspension assembly 34c about the central axis 112 and / or the lateral axis 114, the detector or detector housing 36c may translate along the ring axis 104 to position or substantially position the distal end 264 of the detector or detector housing 36c within the aperture 62 of the anchor assembly 32. The tether 76 may be tightened against the flexible cover portion 60 while maintaining the pitch angle φ to enhance contact between the detector or detector housing 36 and the patient.

[0129] Functionally, the tether connection length adjustment technique enables adjustment of the pitch angle φ without the complexity of a gimbal structure. The technique may be implemented for a locking ring 102c having a right cylindrical interior surface 106c (depicted), as well as for a suspension assembly that does not include a locking ring at all. Alternatively, the technique may also be used in conjunction with a gimbal structure (e.g., with the probe suspension assembly 34a), for example, to provide a coarse adjustment of the pitch angle φ, while using the gimbal structure to finely adjust the pitch angle φ.

[0130] In some embodiments, some or all of the components of the disclosed probe holder assembly 30 are provided as a kit 400 (in Figure 4 and 5 Place description). Figure 4 and 5 In addition to the components depicted in , the kit 400 may also include a probe (not depicted), such as an ultrasound probe configured to be coupled within the probe housing 36. The kit may include instructions for use 402. The instructions 402 are provided on a tangible non-transitory medium and may be physically contained within the kit 400, such as on a printed document (depicted), an optical disk, or a flash drive. Non-limiting examples of tangible non-transitory media include paper documents and computer-readable media, including optical disks and magnetic storage devices (e.g., hard disks, flash drives, cassette tapes, floppy disk drives). Computer-readable media may be local or accessible via the Internet. The instructions 402 may be completed on a single medium or divided among two or more media. For example, some of the instructions 402 may be written on a paper document that instructs a user to access one or more steps of the method via the Internet, and the Internet-accessible steps are stored on one or more computer-readable media. The instructions 402 may use text, photos, videos, or a combination thereof to embody the techniques and methods depicted or described herein to instruct and guide the user. Instructions 402 may be in the form of written text, graphics, photos, video presentations, or a combination thereof to instruct and guide the user.

[0131] The following references are hereby incorporated by reference in their entirety: International Patent Application No. WO 2022 / 136925 filed by Campos et al. on December 23, 2021; International Patent Application No. WO 2021 / 094824 filed by Campos et al. on November 11, 2020; International Patent Application No. WO 2019 / 096943 filed by Garona et al. on November 15, 2018; International Patent Application No. WO 2017 / 052363 by Zhang et al.; International Patent Application No. WO 2010 / 017295 by Vezina; U.S. Patent Application Publication No. 2020 / 0015780 by Gillen et al.; Teveldt et al. Velde et al., U.S. Patent Application Publication No. 2020 / 0178932; Scharf et al., U.S. Patent Application Publication No. 2014 / 0107435; Puy et al., European Patent No. 0327459; Atkov et al., U.S. Patent No. 4,483,344; "North Star Tool Design Guide", 6th Edition (NDI, Waterloo, Ontario, Canada, 2018). Any incorporation of the above documents by reference in this article is limited so that no subject matter contrary to the explicit disclosure in this article will be incorporated. Any incorporation of the above documents by reference is further limited so that any patent claims contained in the documents will not be incorporated by reference in this article. Any incorporation of the above documents by reference is further limited so that any definitions provided in the documents will not be incorporated by reference in this article unless expressly included in this article.

[0132] Each of the additional features and methods disclosed herein may be used alone or in combination with other features and methods to provide improved devices and methods for making and using the same. Therefore, the combination of features and methods disclosed herein may not be necessary to practice the present disclosure in its broadest sense and, instead, the combination of features and methods is disclosed only for the specific description of representative and preferred embodiments.

[0133] Various modifications to the embodiments may be apparent to those skilled in the art after reading this disclosure. For example, those skilled in the art will recognize that various features described for different embodiments may be appropriately combined, uncombined, and recombined with other features, either alone or in different combinations. Likewise, the various features described above should all be considered exemplary embodiments, rather than limitations on the scope or spirit of the disclosure.

[0134] Those skilled in the art will recognize that various embodiments may include fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the 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 understood by those skilled in the art.

[0135] Unless otherwise indicated, references to "embodiments," "disclosure," "present disclosure," "embodiments of the present disclosure," "disclosed embodiments," etc. contained in this document refer to the specification (text including claims, and figures) of this patent application that is not admitted to be prior art.

[0136] For purposes of claim interpretation, it is expressly intended that the provisions of 35 USC 112(f) not be invoked unless the specific terms "means for" or "step for" are recited in the corresponding claim.

Claims

1. A detector holder assembly, comprising: a detector housing for housing the detector, the detector housing comprising a proximal end and a distal end separated by a side wall having an exterior surface; Anchor assembly comprising a flexible covering portion defining an aperture for passage of the distal end of the probe housing, the aperture defining a positioning axis and being co-linear with the positioning axis, an adhesive layer covering the distal end surface of the flexible covering portion, and a plurality of ties coupled to the flexible cover portion and extending in a proximal direction from the flexible cover portion; as well as A detector suspension assembly is used to couple to the detector housing and the anchor assembly, the detector suspension assembly comprising a locking ring defining and being co-linear with a ring axis and having an interior surface configured to engage the exterior surface of the sidewall of the probe housing to secure the locking ring to the probe housing, and one or more buckles for selectively grasping the plurality of straps of the anchor assembly to apply tension and maintain the plurality of straps in tension, the one or more buckles being coupled to the locking ring, The detector suspension assembly is separated from the flexible covering portion by the plurality of ties.

2. The detector holder assembly of claim 1, wherein the anchor assembly comprises a plurality of tether anchors attached to the flexible cover portion, each of the plurality of tether anchors being connected to a corresponding one of the plurality of tethers. 3 . The probe holder assembly of claim 1 , wherein the interior surface of the locking ring and the exterior surface of the probe housing are configured to statically secure the locking ring to the probe housing by friction.

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

5. The probe holder assembly of claim 4, wherein the friction force is overcome by a torsional force applied to the probe housing about the ring axis, the torsional force exceeding the range of 1 Newton meter to 2.5 Newton meters, inclusive. 6 . The probe holder assembly of claim 1 , wherein the probe housing is configured to couple with the 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 buckles are adjustable along the plurality of tethers to define a pitch angle of the ring axis relative to the locating axis.

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

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

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

11. The probe holder assembly of claim 1, wherein the interior surface of the locking ring and the exterior surface of the probe housing define complementary profiles for capturing 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 exterior surface of the sidewall is convex and the arcuate profile of the interior surface of the locking ring is concave.

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

15. The probe holder assembly of claim 12, wherein the arcuate profiles cooperate to enable orientation of the probe housing 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 feed-through for wires of the probe.

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

22. A detector holder assembly comprising: A detector suspension assembly, which is used to couple with the detector, the detector suspension assembly comprising: a locking ring defining and being co-linear with a ring axis and having an interior surface configured to capture and secure the probe; and One or more buckles for selectively grasping a plurality of laces, the one or more buckles being coupled to the locking ring.

23. A detector holder assembly according to claim 22, wherein each of the one or more buckles includes an actuation mechanism having a lever that engages at least one of the plurality of straps, the lever being configured to selectively disengage from the at least one of the plurality of straps.

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 maintain the lever engaged with the at least one of the plurality of tethers.

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

27. The probe holder assembly of claim 23, wherein the lever secures a serrated surface of the at least one of the plurality of ties against a tip 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. The probe holder assembly of claim 28, wherein the first locking ring segment and the second locking ring segment are pivotally connected to each other.

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

31. A detector holder assembly according to claim 28, wherein the detector suspension assembly includes a lock, which extends from the first locking ring segment to the second locking ring segment for interlocking the first locking ring segment with the second locking ring segment into a fully closed configuration, thereby statically fastening the detector suspension assembly to the detector.

32. The probe holder assembly of claim 31 , wherein the lock comprises a finger ring for manual actuation.

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

34. The probe holder assembly of claim 31 , wherein the lock comprises a notch and a protrusion.

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

36. The probe holder assembly of claim 35, wherein: In the partially closed configuration, the detector is captured by the locking ring and is rotatable within the locking ring; and In the fully closed configuration, the detector is captured by the locking ring and is in a fixed angular relationship with the locking ring.

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

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

39. The probe holder assembly of claim 38, wherein the twist-lock arrangement comprises a locking pin that mates with a locking groove.

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

41. A probe holder assembly comprising an anchor assembly, the anchor assembly comprising: a flexible cover portion defining an aperture, the aperture defining a locating axis and being concentric about the locating axis; a plurality of tether anchors coupled to the flexible cover portion; and A plurality of laces, each lace connected to a corresponding one of the plurality of lace anchors, the plurality of laces extending in a proximal direction from the plurality of lace anchors.

42. The probe holder assembly of claim 41, wherein the flexible covering is a mesh configuration.

43. The probe holder assembly of claim 41 or 42, wherein the flexible covering is one of a cloth material, a polymer material and a rubber material.

44. The probe holder assembly of claim 41, wherein the tether of the plurality of tethers is a cable tether.

45. The probe holder assembly of claim 41, wherein the plurality of tether anchors extend in a proximal direction through the flexible cover portion.

46. ​​The probe holder assembly of claim 41, wherein the plurality of tether anchors are coupled to a distal surface of the flexible cover portion.

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

48. The probe holder assembly of claim 47, wherein the adhesive layer covers distal-facing surfaces of the plurality of tether anchors.

49. A detector holder assembly according to claim 41, comprising a detector suspension assembly, which is used to couple to the anchor assembly and includes one or more buckles for selectively grasping the multiple straps of the anchor assembly to apply tension and maintain the multiple straps in tension.

50. A detector holder assembly according to claim 49, wherein each of the one or more buckles includes an actuating mechanism having a lever, the lever engaging at least one of the plurality of straps, the lever being configured to selectively disengage from at least one of the plurality of straps to freely position the detector suspension assembly in the proximal and distal directions along the positioning axis.

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

52. The probe holder assembly of claim 41, comprising 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, and A plurality of markers are coupled to the body portion, the markers being configured to be viewed with a camera.

53. A detector holder assembly comprising: a detector housing for housing the detector, the detector housing comprising a proximal end and a distal end separated by a side wall having an exterior surface; as well as 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, and a plurality of markers coupled to the body portion, the markers being configured to be viewed with a camera, Wherein the detector housing and the marker assembly are configured to be coupled in a fixed angular relationship about the body axis.

54. A detector holder assembly according to claim 53, wherein the coupling includes a plurality of locating pins, which are mounted to one of the detector housing and the marker assembly for insertion into corresponding openings defined on the other of the marker assembly and the detector housing.

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

56. The probe holder assembly of claim 53, wherein the marker is configured to be detected by an infrared camera.

57. 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. A detector holder assembly comprising: 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, and a plurality of markers coupled to the body portion, the markers configured to be viewed with a camera; as well as A handle assembly has a distal end configured for selective coupling to the proximal end of the marker assembly.

59. The probe holder assembly of claim 58, wherein: The marker assembly includes a first connector located at the proximal end of the body portion; The handle assembly includes a second connector at the distal end of the handle assembly; and When fully engaged, the first connector and the second connector maintain the marker assembly and the handle assembly in a fixed axial and rotational relationship.

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

61. The probe holder assembly of claim 59, wherein the first connector and the second connector include a polygonal interface to maintain the rotational relationship.

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

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

64. A method for positioning a detector on a patient for hands-free operation, comprising: Providing a kit including an anchor assembly, a detector suspension assembly, and a detector housing; as well as Providing instructions on a tangible, non-transitory medium, the instructions comprising: adhesively coupling the flexible cover portion of the anchor assembly to the anatomical location of the patient; depressing the opposing plunger mechanisms on the detector suspension assembly to freely position the detector housing along the positioning axis of the anchor assembly; and When the probe housing is in a desired contact condition with the patient's anatomical location, the opposing plunger mechanisms on the probe suspension assembly are released to couple the probe suspension assembly to the anchor assembly.

65. The method of claim 64, wherein the instructions provided in the step of providing instructions include: During the step of depressing the opposing plunger mechanism, the probe suspension assembly is rotated about a transverse axis of the probe suspension assembly to define a pitch angle of the probe housing relative to the locating axis, the transverse axis being orthogonal to an actuation axis of the opposing plunger mechanism.

66. The method of claim 64, wherein the instructions provided in the step of providing instructions include: During the step of pressing the opposing plunger mechanism, the probe suspension assembly is rotated about a central axis of the probe suspension assembly to define a pitch angle of the probe housing relative to the positioning axis, the central axis being orthogonal to an actuation axis of the opposing plunger mechanism.

67. The method of claim 66, wherein the instructions provided in the step of providing instructions include: During the step of depressing the opposing plunger mechanism, the probe suspension assembly is rotated about a transverse axis of the probe suspension assembly to define the pitch angle of the probe housing relative to the locating axis, the transverse axis being orthogonal to an actuation axis of the opposing plunger mechanism.

68. The method of claim 64, wherein the step of releasing the relative plunger mechanism comprises coupling to a plurality of laces to hold the laces in tension.

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

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

71. A method for orienting a probe on a patient for hands-free operation, comprising: A kit is provided which includes the detector suspension assembly and the detector housing; as well as Providing instructions on a tangible, non-transitory medium, the instructions comprising: configuring a locking ring of the detector suspension assembly into a partially closed configuration; rotating the detector housing within the detector suspension assembly to a desired orientation; and The locking ring is configured in a fully closed configuration to secure the probe housing in the desired orientation.

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

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

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