Medical imaging method using multiple arrays - Patent Application 20070122967

Abstract

Disclosed herein are systems and methods for visualizing a target anatomical region of a patient using one or more imaging devices. The method may include positioning multiple imaging devices at multiple locations in the anatomical region. The method may further include generating separate image datasets from the multiple images and combining the image datasets to generate volumetric imaging data of the anatomical region. The volumetric imaging data may include all anatomical features within the target anatomical region. A visualization system for medical imaging may include a transducer in the imaging device to visualize the target anatomical region. The system may further include a processor to combine the image datasets to generate the volumetric imaging dataset. The system may further include a display device to display the volumetric imaging dataset.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of the filing dates of U.S. Provisional Patent Application No. 62 / 678,885, filed May 31, 2018, U.S. Provisional Patent Application No. 62 / 678,868, filed May 31, 2018, and U.S. Provisional Patent Application No. 62 / 678,854, filed May 31, 2018, the disclosures of which are incorporated herein by reference in their entireties. [Background technology]

[0002] The insertion of intravenous needles and cannulas, whether for the withdrawal of blood, the administration of drugs or other compositions, etc., is one of the most widely performed medical procedures in modern medicine.

[0003] Despite its widespread use in numerous applications, the insertion of needles and cannulas into a patient's circulatory system (e.g., blood vessels, veins, arteries, microvasculature, etc.) is an imprecise procedure that often relies on the experience of the user or operator (e.g., doctor, nurse, phlebotomist, technician, etc.) to find hidden and unstable targets and, in some cases, can require multiple attempts. This procedural imprecision causes anxiety, discomfort, and potentially psychological and / or physical injury to the patient.

[0004] In recent years, there have been numerous attempts to modernize this process by introducing automation and imaging and computerized assistance, as well as pain distraction. However, the resulting concepts and designs, particularly with regard to imaging and automation, have proven unintuitive and cumbersome for operators, and often as uncertain and unpredictable as traditional methods. Therefore, there is a need for improved devices that achieve greater accuracy in needle insertion while also having a user-friendly design and size for easy use by operators, including inexperienced and untrained operators.

[0005] Visualization of body regions is a critical requirement for successfully diagnosing various medical conditions and / or performing various surgical procedures. Complex and expensive visualization devices, such as current ultrasound imaging systems, limit or prevent the application of three-dimensional visualization for many surgical procedures. For example, despite its widespread use in many applications, the insertion of needles and cannulas into a patient's circulatory system (e.g., blood vessels, veins, arteries, microvasculature, etc.) is an imprecise procedure that often relies on the experience of the user or operator (e.g., doctor, nurse, phlebotomist, technician, etc.) to find hidden, unstable targets and may require multiple attempts. This procedural imprecision leads to patient anxiety, discomfort, and potentially mental and / or physical injury.

[0006] The imprecision of this procedure can be exacerbated by certain characteristics of a patient's circulatory system. For example, blood vessels are often superficial, small, and mobile. Additionally, blood vessels can be obstructed by bone or tissue during computerized imaging, resulting in incomplete volumetric cardiac images. Such characteristics can increase the risk of errors and reduce the robustness and reliability of the image dataset.

[0007] In recent years, there have been numerous attempts to improve visualization devices and systems to facilitate medical diagnosis and treatment. However, the resulting concepts and designs have proven to be rather cumbersome, particularly in terms of complexity and cost, and in many cases, to be as inaccurate and unpredictable as traditional methods. Furthermore, current visualization devices suffer from an inability to adequately image anatomical structures that may be obscured by dense structures, such as bone, which can hinder the operator's ability to obtain clear images of the target anatomical structure and result in inappropriate treatment.

[0008] Therefore, there is a need for improved visualization devices that provide real-time three-dimensional visualization of body regions for medical diagnosis and / or for performing medical procedures. Summary of the Invention

[0009] The present disclosure generally relates to visualization techniques associated with devices used in medical procedures. In particular, the present disclosure relates to such devices that can perform a variety of functions, including, for example, locating potential intravenous injection puncture sites in a patient, navigating and maneuvering a needle or cannula to the located puncture site (which may include fine-tuning or automatic correction of the location and / or trajectory of a manually or semi-manually inserted needle or cannula via targeting and / or needle stabilization), and moving the needle or cannula through the puncture site to a desired location within the patient's circulatory system. Needle navigation is improved by the ability to image the patient's anatomy from different locations using triangulation. Specifically, when anatomical features (e.g., bone, tissue) obstruct the view of a blood vessel in one plane, multi-panel imaging can be used to obtain a complete volumetric image of the patient's anatomy for needle insertion.

[0010] In a first aspect of the present disclosure, a medical imaging method using multiple imaging devices is provided. The method may include the following steps: positioning a first imaging device at a first location relative to an anatomical region, positioning a second imaging device at a second location relative to the anatomical region, generating a first volumetric image data set using the first imaging device, generating a second volumetric image data set using the second imaging device, and combining the first volumetric image data set and the second volumetric image data set to generate a third volumetric imaging data set of the anatomical region. The third volumetric imaging data set of the anatomical region may include all anatomical features within a volume defined by the volumetric imaging data.

[0011] According to a first aspect, the anatomical features may include hard and soft tissues.

[0012] According to the first aspect, the method may include displaying the third volumetric imaging data set on a display screen.

[0013] According to a first aspect, the first imaging device can be in a first plane at a first location, and the second imaging device can be in a second plane at a second location, and the first and second planes can be on opposite sides of the anatomical region.

[0014] According to the first aspect, the step of combining the first volumetric image data set and the second volumetric image data set to generate a third volumetric imaging data set of the anatomical region may further include combining volumetric image data from the third image data set and a fourth image data set.

[0015] In a second aspect of the present disclosure, a medical imaging system is provided. The medical imaging system may include a first imaging device, a second imaging device, a processor, and a display device. The first imaging device may be configured to generate a first image dataset of an anatomical region from a first location. The second imaging device may be configured to generate a second image dataset of the anatomical region from a second location. The processor may combine the first image dataset with the second image dataset to generate a volumetric image dataset. The display device may display the volumetric image dataset. The volumetric imaging dataset of the anatomical region may include all anatomical features within a volume defined by the volumetric imaging dataset.

[0016] According to a second aspect, the display device may include multiple screens, each of which may be perpendicular to at least one other screen.

[0017] According to a second aspect, the first imaging device may have a length and width that define a first footprint, and the second imaging device may have a second footprint defined by a depth and a length, such that the volume of the volumetric image dataset is defined by the length, width, and depth.

[0018] According to a second aspect, the volumetric imaging data may display all anatomical features within the volume.

[0019] According to a second aspect, anatomical features occluded by bone in the first image data may be captured by the second image data.

[0020] In a third aspect of the present disclosure, a medical imaging system is provided. The medical imaging system may include an imaging device and a transducer array. The imaging device may be configured to generate a volumetric image dataset of an anatomical region. The transducer array may be located on a distal surface of the imaging device. The array may have a length and a width that define a first footprint. The array may generate the volumetric image dataset. The volumetric image dataset may be defined by a volume defined by the length, width, and depth. The volumetric imaging dataset of the anatomical region may include all anatomical features within the volume.

[0021] In a fourth aspect of the present disclosure, a medical imaging system is provided. The medical imaging system may include an imaging device and a transducer array. The imaging device may be configured to generate a volumetric image dataset of an anatomical region. The transducer array may be located on a distal surface of the imaging device. The array may have a length and a width that define a first footprint. The array may generate the volumetric image dataset. The volumetric image dataset may be defined by a volume defined by a length, width, and depth such that all anatomical features within the volume are included in the volumetric image dataset.

[0022] In a fifth aspect of the present disclosure, a medical imaging system is provided. The medical imaging system may include an imaging device, a first array of transducers, and a second array of transducers. The imaging device may be configured to generate a volumetric image dataset of an anatomical region. The first array of transducers may be located in a first plane of the imaging device. The first array may have a first length and a first width that define a first footprint. The second array of transducers may be located in a second plane of the imaging device. The second array may have a second length and a second width that define a second footprint. The first plane may be tilted and away from the second plane to define a gap between the first and second planes. The projection areas of the first footprint and the second footprint may intersect so that a volume under the gap is included in the volumetric image dataset generated by the imaging device.

[0023] In a sixth aspect of the present disclosure, a medical imaging system is provided. The medical imaging system may include an imaging device, a first array of transducers, and a second array of transducers. The imaging device may be configured to generate a volumetric image dataset of an anatomical region. The first array of transducers may be located on a first surface of the imaging device. The first array may define a first footprint. The second array of transducers may be located on a second surface of the imaging device. The second array may define a second footprint. The first surface may be spaced from the second surface to define a gap between the first and second surfaces. A projection area of ​​the first footprint and a projection area of ​​the second footprint may intersect such that a volume under the gap is included in the volumetric image dataset generated by the imaging device.

[0024] In a seventh aspect of the present disclosure, a medical imaging method using an imaging device is provided. The method may include the following steps: positioning the imaging device adjacent to an anatomical region, the imaging device including multiple transducers, the multiple transducers defining an area bounded by a length and a width, the anatomical region including hard and soft tissues, the hard tissues being located between the imaging device and the soft tissues, the hard tissues including one or more gaps; generating an image dataset from signals transmitted and received by each of the multiple transducers; and generating a volumetric image dataset by combining the image datasets, the volumetric image dataset being defined by a volume bounded by an area and a depth such that the hard and soft tissues are included in the volumetric image dataset. Signals transmitted by each transducer located immediately above the hard tissues may propagate through the gaps and branch to contact the soft tissues.

[0025] According to a seventh embodiment, the hard tissue may be bone and the soft tissue may be an organ.

[0026] According to the seventh aspect, the propagated signal may collect data for all or substantially all soft tissue.

[0027] According to a seventh aspect, the imaging device may include a display screen for displaying the volumetric image dataset. A display may be coupled to the imaging device. The display may include a parallax display for moving the volumetric image dataset relative to the operator's line of sight. The parallax may allow the operator to view portions of the target anatomical structure that may be underlying other portions of the anatomical structure. The parallax display may allow the operator to view soft tissue located beneath hard tissue.

[0028] In an eighth aspect of the present disclosure, a medical imaging method using an imaging device is provided. The method according to this aspect may include the following steps: positioning the imaging device adjacent to an anatomical region, generating an image dataset from signals transmitted and received by individual transducer arrays, and generating a volumetric image dataset by combining the image datasets. The imaging device may include multiple transducer arrays. The multiple transducer arrays may define an area bounded by a length and a width. The anatomical region may include hard tissue and soft tissue. The hard tissue may be located between the imaging device and the soft tissue. The hard tissue may include one or more gaps. The processor may select individual transducer arrays to generate and receive signals. The volumetric image dataset may be defined by a volume bounded by an area and a depth such that the hard tissue and soft tissue may be included in the volumetric image dataset. The processor may combine the individual image datasets with location information of the corresponding individual transducer arrays to generate the volumetric image dataset. Signals transmitted by each transducer located immediately above the hard tissue may propagate through the gaps and branch to contact the soft tissue.

[0029] A more complete understanding of the present subject matter and its various advantages may be realized by reference to the following detailed description, in which reference is made to the accompanying drawings, in which: [Brief explanation of the drawings]

[0030] [Figure 1A-1B] 1A-1C are views of one embodiment of a device of the present disclosure from different viewing angles. [Figures 1C-1I] 1A-1C are views of one embodiment of a device of the present disclosure from different viewing angles. [Figure 2A-2B] 10A-10C show views of another embodiment of the device of the present disclosure from different viewing angles. [Figures 2C-2D] 10A-10C show views of another embodiment of the device of the present disclosure from different viewing angles. [Figure 2E]10A-10C show views of another embodiment of the device of the present disclosure from different viewing angles. [Figure 3A-3B] 10A-10C are views of yet another embodiment of a device of the present disclosure from different viewing angles. [Figures 4A-4D] 1A-1D illustrate various embodiments of the device of the present disclosure. [Figures 4E-4G] 1A-1D illustrate various embodiments of the device of the present disclosure. [Figure 4H-4I] 1A-1C illustrate representative and exemplary placement of a device of the present disclosure in a patient. [Figures 5A-5D] 10A-10C illustrate exemplary movements of the housing of one embodiment of the present disclosure. [Figures 6A-6B] 1A-1D illustrate various embodiments of the device of the present disclosure. [Figures 7A-7B] 1A-1D illustrate various embodiments of the device of the present disclosure. [Figure 8A] 1A-1D illustrate various embodiments of a compression garment of the present disclosure. [Figure 8B-8C] 1A-1D illustrate various embodiments of a compression garment of the present disclosure. [Figure 8D-8E] 1A-1D illustrate various embodiments of a compression garment of the present disclosure. [Figure 9A-9B] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figure 9C-9D] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figure 9E] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figure 9F-9I] FIG. 10 illustrates another embodiment of a device of the present disclosure and a representative display image. [Figures 10A-10E] 1A-1C illustrate various embodiments of a display (GUI) of the present disclosure. [Figures 11A-11C] 1A-1C illustrate various embodiments of a display (GUI) of the present disclosure. [Figures 12A-12C] 1A-1C illustrate various embodiments of a display (GUI) of the present disclosure. [Figures 13A-13B] 1A-1C illustrate various embodiments of a display (GUI) of the present disclosure. [Figure 14]1A-1C illustrate various embodiments of displays of the present disclosure. [Figure 15] 1A-1C illustrate various embodiments of displays of the present disclosure. [Figures 16A-16B] 1A-1D illustrate various embodiments of the needle actuation system of the present disclosure. [Figures 17A-17B] 1A-1D illustrate various embodiments of the needle actuation system of the present disclosure. [Figure 18-19] 1A-1C illustrate various embodiments of patches of the present disclosure. [Figures 20A-20B] 1 illustrates one embodiment of a skirt of the present disclosure. [Figures 21A-21B] 1A and 1B are perspective and exploded views of another embodiment of a device of the present disclosure. [Figure 22] FIG. 10 illustrates another embodiment for the device of the present disclosure. [Figures 23A-23C] 1A-1C illustrate various embodiments of straps of the present disclosure. [Figures 24A-24B] 10A-10C illustrate another embodiment of a strap of the present disclosure. [Figure 24C] 10A-10C illustrate another embodiment of a strap of the present disclosure. [Figure 25A] 1A-1C illustrate various embodiments of straps of the present disclosure. [Figure 25B] 1A-1C illustrate various embodiments of straps of the present disclosure. [Figure 25C] 1A-1C illustrate various embodiments of straps of the present disclosure. [Figure 25D] 1A-1C illustrate various embodiments of straps of the present disclosure. [Figure 25E] 1A-1C illustrate various embodiments of straps of the present disclosure. [Figure 25F] 1A-1C illustrate various embodiments of straps of the present disclosure. [Figures 25G-25I] 1A-1C illustrate various embodiments of straps of the present disclosure. [Figure 26A] 1A-1C illustrate embodiments of attachment means of the present disclosure. [Figure 26B] 1A-1C illustrate embodiments of attachment means of the present disclosure. [Figure 27] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figure 28] 1A-1D illustrate various embodiments of the inserter assembly of the present disclosure. [Figure 29] 1A-1D illustrate various embodiments of the inserter assembly of the present disclosure. [Figure 30] 1A-1D illustrate various embodiments of the inserter assembly of the present disclosure. [Figure 31A] 1A-1D illustrate various embodiments of the inserter assembly of the present disclosure. [Figure 31B] 1A-1D illustrate various embodiments of the inserter assembly of the present disclosure. [Figure 31C] 1A-1D illustrate various embodiments of the inserter assembly of the present disclosure. [Figure 32] 1 is a schematic perspective view of a visualization device according to one embodiment of the present disclosure; FIG. [Figure 33] 33 is a schematic perspective view of the visualization device of FIG. 32 positioned in a target body zone. [Figures 34A-34C] 33A-33C are plan, side, and front views of the visualization device of FIG. 32. [Figure 35A-35B] 35A and 35B are side and front views of the visualization device of FIG. 32 and FIG. 35A, respectively, positioned in a target body zone. [Figure 36A] FIG. 10 is a schematic perspective view of a visualization device according to another embodiment of the present disclosure. [Figure 36B] FIG. 36B is a schematic perspective view of the display of the visualization device of FIG. 36A detached from the frame. [Figure 37] FIG. 10 is a schematic perspective view of a visualization device according to yet another embodiment of the present disclosure. [Figure 38A-38B] 10A-10C are schematic perspective views of a visualization device according to yet another embodiment of the present disclosure, viewed from a first perspective and a second perspective. [Fig. 38C-38D] 1A and 1B are schematic front and perspective views of a visualization device 100 displaying a parallax view according to another embodiment of the present disclosure; [Figure 38E-38G] FIG. 38D is a schematic top view of the visualization device of FIG. 38C. [Figure 39] FIG. 10 is a schematic perspective view of a visualization device according to yet another embodiment of the present disclosure. [Figure 40] FIG. 1 is a schematic perspective view of a transducer array according to one embodiment of the present disclosure. [Figures 41A-41C] FIG. 41 is a schematic perspective view showing three-dimensional visualization from two-dimensional images produced by the transducer array of FIG. 40. [Figure 42] FIG. 10 is a schematic perspective view of a transducer array according to another embodiment of the present disclosure. [Figure 43] FIG. 10 is a schematic perspective view of a transducer array according to a further embodiment of the present disclosure. [Figure 44] FIG. 10 is a front view of a transducer array according to yet another embodiment of the present disclosure. [Figure 45] FIG. 10 is a front view of a transducer array according to yet another embodiment of the present disclosure. [Figure 46-47] 1A-1C are schematic perspective and front views of a transducer array according to another embodiment of the present disclosure. [Figure 48] FIG. 10 is a schematic perspective view of a transducer array according to yet another embodiment of the present disclosure. [Figure 49] FIG. 10 is a schematic perspective view of a transducer array according to a further embodiment of the present disclosure. [Figure 50] FIG. 10 is a side view of a transducer array according to another embodiment of the present disclosure. [Figure 51] FIG. 10 is a schematic perspective view of a transducer array according to yet another embodiment of the present disclosure. [Figure 52] FIG. 10 is a schematic perspective view of a transducer array according to a further embodiment of the present disclosure. [Figure 53] 1 is a flow chart illustrating steps for performing a surgical procedure using a visualization device of one embodiment of the present disclosure. [Figure 54] 10 is a flow chart illustrating steps for performing a surgical procedure using a visualization device of another embodiment of the present disclosure. [Figure 55] FIG. 7D is a schematic perspective view of the visualization device of FIG. 7C. [Figures 56A-56C]FIG. 33 is a schematic top view of the visualization device of FIG. 32 showing a graphical user interface display of one embodiment of the present disclosure. [Figures 57A-57C] FIG. 33 is a schematic top view of the visualization device of FIG. 32 showing a graphical user interface display of another embodiment of the present disclosure. [Figures 58A-58C] FIG. 33 is a schematic top view of the visualization device of FIG. 32 showing a graphical user interface display of another embodiment of the present disclosure. [Figure 59] FIG. 33 is a schematic perspective view of the visualization device of FIG. 32 showing a graphical user interface display of another embodiment of the present disclosure. [Figures 60A-60C] FIG. 33 is a schematic top view of the visualization device of FIG. 32 showing a graphical user interface display of another embodiment of the present disclosure. [Figure 61] FIG. 33 is a schematic top view of the visualization device of FIG. 32 showing a graphical user interface display of another embodiment of the present disclosure. [Figure 62] FIG. 33 is a schematic perspective view of the visualization device of FIG. 32 showing a graphical user interface display of another embodiment of the present disclosure. [Figure 63A-63B] FIG. 33 is a schematic top view of the visualization device of FIG. 32 showing a graphical user interface display of one embodiment of the present disclosure. [Figure 63C-63D] FIG. 33 is a schematic top view of the visualization device of FIG. 32 showing a graphical user interface display of one embodiment of the present disclosure. [Figure 64A-64B] FIG. 33 is a schematic top view of the visualization device of FIG. 32 showing a graphical user interface display of one embodiment of the present disclosure. [Figures 65A-65E] FIG. 1 illustrates one embodiment of a method of use of the device of the present disclosure. [Figures 66A-66E] 1A-1C illustrate various locations where devices of the present disclosure may be used. [Figures 67A-67C] FIG. 1 illustrates one embodiment of a device of the present disclosure. [Figures 68A-68D]FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figures 69A-69C] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figures 70A-70C] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figures 71A-70D] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figure 72A-72B] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figure 73A-73B] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figures 74A-74C] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figures 75A-75C] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figure 76A-76B] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figures 77A-77C] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figures 78A-78C] FIG. 10 illustrates another embodiment of the device of the present disclosure. [Figure 79A] 1A-1C illustrate various embodiments of the targeting functionality of the present disclosure. [Figure 79B] 1A-1C illustrate various embodiments of the targeting functionality of the present disclosure. [Figure 79C] 1A-1C illustrate various embodiments of the targeting functionality of the present disclosure. [Figure 79D] 1A-1C illustrate various embodiments of the targeting functionality of the present disclosure. [Figure 79E-79G] 1A-1C illustrate various embodiments of the targeting functionality of the present disclosure. [Figure 79H] 1A-1C illustrate various embodiments of the targeting functionality of the present disclosure. [Figures 80A-80C] 1 illustrates one embodiment of a pad of the present disclosure. [Figures 81A-81C] 10A-10C illustrate another embodiment of a pad of the present disclosure. [Figures 82A-82D] 10A-10C illustrate another embodiment of a pad of the present disclosure. [Figure 83A-83I] 81A-81C show various embodiments of the pad shown in FIGS. 81A-81C. [Figure 84] FIG. 10 illustrates a pad according to another embodiment of the present disclosure. [Figures 85A-85C] 10A-10C illustrate a needle insertion procedure according to various embodiments of the present disclosure. [Figure 86A] FIG. 1 illustrates a device having an inserter assembly according to one embodiment of the present disclosure. [Figure 86B] FIG. 86B is a top view of the inserter assembly of the device of FIG. 86A. [Figure 87] FIG. 86C shows a cross-sectional view of the inserter assembly of FIG. 86B. [Figure 88] FIG. 86C shows another cross-sectional view of the inserter assembly of FIG. 86B. [Figures 89A-89C] FIG. 86C shows the needle drive of the inserter assembly of FIG. 86B. [Figure 90] FIG. 10 is a front view of an inserter assembly according to another embodiment of the present disclosure. [Figure 91] FIG. 91 is a top view of the inserter assembly of FIG. 90. [Figure 92] FIG. 91 is a cross-sectional view of the inserter assembly of FIG. 90. [Figures 93A-93F] FIG. 91 is a diagram of the components of the inserter assembly of FIG. 90. [Figure 94] FIG. 10 is a front view of an inserter assembly according to another embodiment of the present disclosure. [Figure 95] FIG. 95 is a top view of the mechanism of the inserter assembly of FIG. 94. [Figure 96] FIG. 95 is a side view of the mechanism of the inserter assembly of FIG. 94. [Figure 97] FIG. 10 is an isometric view of an inserter assembly according to another embodiment of the present disclosure. [Figure 98] 98 shows a schematic side view of the mechanism of the inserter assembly of FIG. 97. [Figure 99] FIG. 98 is a top view of the mechanism of the inserter assembly of FIG. 97; [Figure 100] FIG. 98 is an isometric view of the mechanism of the inserter assembly of FIG. 97; [Figure 101A-101B]FIG. 10 illustrates a visualization device according to another embodiment of the present disclosure. [Figure 102A-102B] FIG. 10 illustrates a visualization device according to another embodiment of the present disclosure. [Figure 103A] FIG. 101B illustrates a method of using the visualization device of FIG. 101A. [Figure 103B-103C] 101B shows a support accessory for the visualization device of FIG. 101A. [Figures 104A-104D] FIG. 10 illustrates a transducer and pad of another embodiment of the present disclosure. [Figure 105] FIG. 10 illustrates a support device according to another embodiment of the present disclosure. [Figure 106] FIG. 106 shows a visualization device of another embodiment of the present disclosure coupled with the support of FIG. 105. [Figures 107A-107D] FIG. 1 illustrates a visualization system according to another embodiment of the present disclosure. [Figure 107E] FIG. 1 illustrates a visualization system according to another embodiment of the present disclosure. [Figure 108A] FIG. 1 shows a kit according to another embodiment of the present disclosure. [Figure 108B] FIG. 1 shows a kit according to another embodiment of the present disclosure. [Figure 108C] FIG. 1 shows a kit according to another embodiment of the present disclosure. [Figure 108D] 108B shows various applications of the kit of FIG. 108A. [Figure 108E] 108B shows various applications of the kit of FIG. 108A. [Figure 108F] 108B shows various applications of the kit of FIG. 108A. [Figure 108G] 108B shows various applications of the kit of FIG. 108A. [Figure 108H] 10 shows a table of visualization device specifications according to another embodiment of the present disclosure. [Figure 109] FIG. 108B shows another application of the kit of FIG. 108A with a customized pad according to another embodiment of the present disclosure. [Figures 110A-110D] FIG. 1 illustrates a visualization system according to another embodiment of the present disclosure. [Figures 111A-112B] 1 illustrates a pad according to one embodiment of the present disclosure. [Figure 113] FIG. 10 illustrates a pad according to another embodiment of the present disclosure. [Figures 114A-114C] 114A and 114B show a pad and an intravenous insertion without the pad of another embodiment of the present disclosure. [Figures 115A-115C] FIG. 10 illustrates a pad according to another embodiment of the present disclosure. [Figure 116] FIG. 1 illustrates a visualization system according to another embodiment of the present disclosure. [Figure 117] FIG. 1 illustrates a visualization system according to another embodiment of the present disclosure. [Figures 118A-118B] 13A-13C illustrate an inserter assembly according to another embodiment of the present disclosure. [Figure 119A-119B] FIG. 1 illustrates a visualization system according to another embodiment of the present disclosure. [Figures 120A-120D] 1 illustrates a venous dilation device according to one embodiment of the present disclosure. [Figure 121] 13A-13C illustrate an inserter assembly according to another embodiment of the present disclosure. [Figures 122A-122D] FIG. 10 illustrates a visualization device according to another embodiment of the present disclosure. [Figure 123] FIG. 10 illustrates a visualization device according to another embodiment of the present disclosure. [Figure 124] FIG. 10 shows a sterile bandage according to another embodiment of the present disclosure. [Figure 125A-125B] FIG. 1 illustrates a needle according to one embodiment of the present disclosure. [Figure 126] 13A-13C illustrate an inserter assembly according to another embodiment of the present disclosure. [Figure 127A-127B] FIG. 10 illustrates a visualization assembly according to another embodiment of the present disclosure. [Fig. 127C-127D] FIG. 10 illustrates a visualization assembly according to another embodiment of the present disclosure. [Figure 128A-128B] FIG. 10 illustrates a visualization assembly according to another embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0031] As used herein, the terms "needle" and "cannula" are used interchangeably, and thus, unless otherwise indicated, the explicit use of either term includes the other. Typically, a cannula is introduced into a patient through the use of a needle, whereby the needle is inserted first, and then the cannula is passed through the needle and into the patient, leaving the cannula behind when the needle is removed. The interchangeable terms needle and cannula also include similar devices, such as microcannulae, sharp and blunt variations thereof, rigid and flexible variations thereof, and other tubular structures. Similarly, the term "circulatory system" refers to any blood vessel, vein, artery, microvasculature, etc. The term "puncture site" refers to a location in a patient where an operator passes a needle or cannula, usually percutaneously, to enter at least a portion of the needle or cannula into the patient. Although the devices, techniques, systems, kits, and methods of the present disclosure typically refer to or provide examples of inserting a needle or cannula into the circulatory system, the present disclosure also contemplates placing the needle or cannula in other anatomical locations, for example, "transosseous" techniques in which at least a portion of the needle is placed within the patient's bone (e.g., within the intramedullary canal).

[0032] As used herein, "semi-autonomous" means that the device can perform a function with some degree of operator (e.g., nurse, technician, doctor, etc.) interaction. For example, a "semi-autonomous" function may require an operator to assist in navigating the device to the general area of ​​the intended puncture site by viewing a user interface and manipulating the device, where the device itself can further navigate to the exact puncture site location. Semi-autonomous may further include an operator holding or controlling the cannula or connected structure to perform some or all of the degree of positioning movements, for example, under image guidance and supplemented with partial robotic placement assistance (e.g., robotic auto-correction capabilities). On the other hand, an "autonomous" or "fully autonomous" function may be able to perform a particular function completely without or with minimal operator interaction, or with minimal operator interaction. For example, once the puncture site is found, the operator can confirm that the location is correct by pressing a button, actuator, display screen gesture, etc., which action causes the device to begin maneuvering the needle to the puncture site and inserting the needle at the puncture site and into the circulatory system, all without interaction from the operator. The terms "semi-autonomous" and "autonomous" may be used generally to describe a device and to describe a particular function, or any group of functions.

[0033] As defined above, "operator" or "user" as used throughout may refer to a single individual or multiple individuals, as the case may be. For example, a single user may perform all of the steps of a particular use of one of the devices described herein, although multiple users may also be involved, with each user performing some but not all of the steps. Continuing with this example, a first user (e.g., a layperson, assistant, first responder, citizen, etc.) may perform the unskilled step of attaching the device to the patient, while a skilled individual (e.g., a technician, doctor, nurse, etc.) performs subsequent steps such as positioning and inserting the needle.

[0034] Herein, the terms "gel pad," "patch," and "pad" will be used interchangeably, and therefore, unless otherwise indicated, an express use of any of these terms includes the other terms. Herein, the terms "needle actuation system," "inserter assembly," and "cannulation module" will be used interchangeably, and therefore, unless otherwise indicated, an express use of any of these terms includes the other terms. Herein, the terms "sensor array," "sensor," and "transducer" will be used interchangeably, and therefore, unless otherwise indicated, an express use of any of these terms includes the other terms.

[0035] The present invention can be used to visualize any desired anatomical structure and / or medical device or instrument, and can further be used alone or in conjunction with any desired medical device or instrument as a visualization tool (e.g., for diagnosis, to view recovery after trauma or surgery, etc.). Similarly, it is envisioned that the present invention will be used in any desired anatomical structure. However, for ease of review and explanation, many of the examples discussed herein will focus on uses in which needles are used to pierce the skin and / or access a patient's vascular system. Such embodiments are merely illustrative and provide an explanation of the benefits associated with the present invention. Furthermore, the present invention can be used as a stand-alone imaging system for any imaging modality, such as abdominal, venous, pelvic, transabdominal, transvaginal, transrectal, obstetric, carotid, and abdominal aortic imaging.

[0036] The sensors for visualization disclosed herein may include capacitive micromachined ultrasonic transducers (CMUTs), piezoelectric micromachined ultrasonic transducers (PMUTs), or any other suitable transducers. However, for ease of review and explanation, many of the examples discussed herein will focus on the use of CMUT sensors.

[0037] In general, the device The devices of the present disclosure are generally applicable to semi-autonomous or fully autonomous needle or cannulation in a patient. Such devices can include various features to provide semi-autonomous or fully autonomous functionality, such as gross and / or fine placement, mapping and tracking elements, needle control and positioning elements, sanitization and puncture site preparation elements, pain management elements, patient distraction elements, and / or the like.

[0038] The devices of the present disclosure can be placed on a patient's skin to generate images from one side to the other. Accordingly, in certain embodiments, these devices are configured to be lightweight, thin, and / or capable of generating images with sufficient resolution and / or to maintain real-time scan control for various procedures. CMUT, PMUT, or other suitable transducers can be used to capture real-time images. In some embodiments, a combination of CMUT and PMUT transducers can be used to optimize the device for a particular application. For example, a device can include CMUT transducers in some areas to obtain detailed imaging data, and PMUT transducers can be used in other areas to reduce the device's power consumption. In addition to the transducers, these devices can include mixed-signal electronics on an integrated circuit that can be attached to the transducer. The device can receive data from the sensing integrated circuit and interface with a display subsystem. For each beam in the scan, a digital component such as a field programmable gate array (FPGA) can transmit the parameters needed by the integrated circuit to determine the beam angle, frequency, and a host of other parameters.

[0039] 1A-1I, in one embodiment of such a device, device 10 of the present disclosure generally includes three components: housing 100, base 200, and inserter assembly 300. Housing 100 includes various elements that provide functionality to the device, such as placement, mapping, and tracking elements, needle control and positioning elements, pain management capabilities, patient distraction capabilities, etc. Therefore, housing 100 must be sized sufficiently to accommodate all such elements. For example, a device used in a hospital that performs multiple routine needle insertions and needs to be able to interface with multiple needles and other accessories may require a relatively large housing, while a device configured to be portable and designed for a specific application that does not need to interface with a variety of needles and other accessories may have a more compact housing.

[0040] The base 200 provides for positioning and securing the device adjacent to the patient's skin surface. As shown, the base may include an outer frame 202 defining an interior volume and having an aperture 204 on at least one surface of the frame 202. The base 200 may be attached to the patient's skin surface and secured thereto by at least one strap attached to the base. The aperture 204 provides a window 206 through which the inserter assembly 300, including the needle and / or cannula, may be positioned. Additionally, the aperture 204 may allow navigational aids (as described below) and / or other elements of the housing 100 to interact with the patient.

[0041] Housing 100 may also include attachment mechanisms to allow the housing to be easily attached and detached from base 200. For example, at least a portion of housing 100 may be disposed within the interior volume of base 200 and held in place by a friction fit, magnetic attraction, a snap fit, or the like. Such an arrangement may allow housing 100 to be in close proximity to window 206, which may provide enhanced functionality for various elements within the housing, as described in more detail below. In an alternative configuration, housing 100 and base 200 may be integrated or even monolithic structures rather than separate, connectable structures.

[0042] Insert assembly 300 may be packaged or stored in a manner that allows for simplified engagement with housing 100. As shown, housing 100 may include recess 101 (FIGS. 1C and 1H-1I) to provide clearance for insert assembly 300 after device 10 is assembled, although other methods for configuring the various elements to align are also envisioned. Insert assembly 300 may include features that contribute to its improved fit, stability, and function within device 10 prior to use, such as fins 301 (FIG. 1E) on either side of aperture 204 that can both rest flat against base 200 to maintain the relative alignment of base 200, assembly 300, and optional protective visor 700 and to provide a stable contact base for assembly 300 against the patient's skin during use.

[0043] In addition to the needle and / or cannula, the inserter assembly 300 may also include clamps and valves, a length of tubing, a filter, a catheter body followed by a luer lock, any combination thereof, etc. As such, the inserter assembly 300 may include an entire infusion system (as commonly known in the art) or any portion of an infusion system, although the inserter assembly will typically include at least a needle and / or cannula to begin the intravenous placement process. Alternatively, the inserter assembly 300 may include only a needle, or a needle and vial, for less complex procedures, such as for drawing a blood sample from a patient. Further examples of inserter assemblies are described below. In the aforementioned alternative configuration of an integrated or unitary structure, the inserter assembly 300 may likewise be part of an integrated or unitary structure.

[0044] The device 10 may further include a protective visor 700 that can be positioned on the bottom of the base 200, as shown in FIG. 1A, so that it is positioned between the base 200 and the patient's skin surface. The visor 700 can serve to hold the inserter assembly 300 within the aperture 204 prior to use and / or prior to connection of the housing 100 to the base 200. Additionally, the visor 700 can have other features that enable it to perform other functions. For example, once a puncture site is determined, the visor 700 may provide a non-sterile surface for use during puncture site location, such that the non-sterile surface can be removed to expose the sterile base 200 surface for placement at the puncture site. Alternatively, for example, the visor 700 may include a sterilizing composition therein to sterilize the skin surface during the placement step of puncture site location. Additionally, for example, the visor, if included on the device, may include optical features that can aid in puncture site scanning and visualization and / or may include a layer of saline hydrogel for use with ultrasound.

[0045] 2A-2E illustrate a device 20 according to another embodiment of the present disclosure. Device 20, similar in some aspects to device 10, includes a housing 400 that can be docked to a base 500. Base 500 may include a patient engagement feature, e.g., at least one strap 508, as shown, for attaching and securing the device to a patient's skin surface. Furthermore, base 500 is constructed to be thinner than base 200 of FIG. 1 , allowing housing 400 to fit into base 500 in a desired manner, such as by magnetic interaction, snap fit, press fit, or the like. Furthermore, because base 500 is constructed of a thinner structure, aperture 504 and inserter assembly 600 are closer to the upper edge of base 500, so housing 400 need not be positioned within the volume of the base. Device 20 can perform a range of functions depending on elements aligned within or attached to housing 400, which, as previously described, may include other features, such as a patch.

[0046] As shown in FIG. 2C , device 20 includes aperture 504 into which plate 550 is placed prior to use. As shown, plate 550 includes a holder 552 that can hold inserter assembly 600 in place relative to base 500 until housing 400 is coupled to the base, which will also fit inserter assembly 600, making plate 550 unnecessary. As such, plate 550 is particularly useful for maintaining the relative position of inserter assembly 600 relative to base 500 within its packaging and prior to use. For example, after the base is removed from its packaging, plate 500 can remain in place, and the base is placed at or near a patient's puncture site. Alternatively, the base can be coupled to housing 400 such that plate 550 is removed after the base is removed from its packaging and before the base is placed on a skin surface. Aperture 504 may be of any desired size, and as shown is quite large to allow freedom of access of the base and the various elements therein to the skin surface.

[0047] 3A-3B illustrate another embodiment of the present disclosure. As shown, device 30 includes a housing 700 and a base 800, where the base in this embodiment is in the form of an enveloping support. Such a base 800 may be particularly useful for locating a puncture site and positioning an inserter assembly (not shown) through a hand or foot. In addition to this embodiment, housing 700 may not be fixed relative to base 800 but may instead be movable through at least one degree of movement. As previously mentioned, the housing may include various electronics for endowing the device with functionality. While the device in FIGS. 1A-2E may be movable along the length of the arm, base 800 is secured with a strap around a specific anatomical structure of the hand or foot. Thus, the base may have limited movement available to it, allowing housing 700 to move relative to the base to locate a puncture site and navigate through the inserter assembly, as described below. Base 800 may also include a compression cuff 801 positioned proximal to the puncture site (i.e., between the puncture site and the heart), either physically and / or electronically integrated with the base as shown, or separate and independent from the base (such as compression cuff 1801 in FIG. 4A). As described further below, an integrated compression cuff, whether physically, electrically, and / or via software, can provide additional functionality to the housing.

[0048] 4A-4I show various embodiments of the device including a base, a housing, each of which may optionally include an integrated compression cuff (however, for ease of illustration, only FIGS. 4A, 4B, 4H, and 4I show a compression cuff). Each of these embodiments may include a separate or modular setup, including a base that is separate from the housing and that may be connected to each other during use, or alternatively, the base and housing may be of integrated construction or even one piece.

[0049] FIG. 4A shows one such embodiment in which device 130 includes a base 1800 and a housing 1700. As shown, base 1800 is elongated in shape with a generally rectangular aperture 1804 that receives housing 1700. While base 1800 is shown with two straps 1808a, 1808b, any number of straps, or indeed any other securing feature for securing the base to a patient, may be included. Housing 1700 may also include an inserter assembly 1900 thereon. Optionally, device 130 may also include a compression cuff 1801 that may be connected to base 1800 and / or housing 1700 via a connector 1802. As shown, connector 1802 may be rigid so that the distance between the compression cuff and base remains constant, resulting in a more stable structure after application to the patient. Alternatively, as described in more detail below, the connector 1802 may be flexible or may simply be a wire connection (eg, for communications, power, etc.) between the compression cuff and the housing.

[0050] Device 130 can provide a simplified setup in which housing 1700 and aperture 1804 allow relative movement between base 1800 and housing 1700 such that base 1800 (and optionally compression cuff 1801) can be secured to the patient so that aperture 1804 matches the general location of the intended puncture site (e.g., on the patient's upper forearm). With base 1800 secured, the user can navigate housing 1700 within aperture 1804 and along and / or on the patient's skin until the desired puncture site is found and inserter assembly 1900 is aligned with it. As shown, housing 1700 can move in any direction within aperture 1804 along either the x-direction (i.e., side to side), the y-direction (i.e., along its length or toward / away from the compression cuff), and / or the z-direction (i.e., toward / away from the patient's skin).

[0051] 4B-4E show various alternative embodiments to device 130. Specifically, each of FIGS. 4B-4D includes a housing and body similar to device 130, but the straps associated with the body are different. For example, the device of FIG. 4B includes a single, offset strap that may be suitable for attachment to a patient's hand or foot. That is, the strap is positioned proximally relative to the housing (and inserter assembly) so that the inserter assembly may be more preferably positioned to align with the desired puncture site, while the strap may be positioned on a more stable, wider portion of the hand or foot. On the other hand, FIG. 4C includes a strap that is generally centered and aligned with the body and housing. Such a variation may be more suitable for placement on the hand or foot, and may also be more suitable for placement elsewhere, such as on the forearm. Similarly, the device of FIG. 4D includes a much wider strap, thereby making it more suitable for placement on the forearm or larger anatomical structures, such as the upper arm or leg. Wider straps may provide additional fixation and stabilization to the device, similar to the two-strap variation of FIG. 4A. The straps may be formed of any material desirable and suitable for use in medical devices that contact a patient's skin and may further include a coating, if desired. For example, the straps may be formed of or include a conductive material, such as a hydrogel, that may aid in navigation and other functions associated with the housing 1700.

[0052] 4E shows a variation of base 1800 in which the base may not completely surround the housing. Instead, the base may be incomplete, such that an aperture 1809 in the base is open. The degree to which the base is complete or incomplete can result in any desired shape.

[0053] FIG. 4F provides yet another embodiment of device 130′, except that, instead of being generally rectangular, base 1800′ includes curved edges, and is thus rectangular with a curve at the opposite edge. Housing 1700′ is similarly shaped as aperture 1804′. Straps 1808′ may also be included and may be of any desired shape. In this embodiment, the width of aperture 1804′ and the width of housing 1700′ may be similar or nearly similar, such that housing 1700′ may move in the y-direction (e.g., along the length of aperture 1804′ and toward either of the curved edges) but have limited or zero movement in the x-direction (e.g., from side to side). Such an embodiment may be useful, for example, in instances where vertical panning of the imaging or navigation functions of housing 1700′ is desired, along with limiting most, if not all, of the side-to-side movement of housing 1700′. Alternatively, the strap may also include a strap aperture that allows the housing to slide in the side-to-side (X-direction) direction (as described below with respect to FIG. 6A).

[0054] 4G-4I illustrate yet another alternative embodiment of device 230 that is similar in some respects to device 130, as device 230 includes base 2800 and housing 2700; however, in this embodiment, both base and housing are generally circular, and base 2800 includes a generally circular aperture 2804 and a single strap 2808. As in the other embodiments described above, device 230 may also include a compression cuff 2801, which may be an integrated aspect of device 230. However, FIGS. 4G-4I illustrate another variation of a compression cuff that may be used in any embodiment disclosed herein, whereby compression cuff 2801 may be electrically connected to housing 2700 via a wired connection 2802, although this connection may be via Bluetooth or other wireless capabilities (e.g., as shown in FIGS. 8D-8E), or other connection. Alternatively, the compression cuff may be completely separate from device 230, both physically and communicatively. 4H-4I illustrate various potential anatomical locations for the devices disclosed herein, whereby device 230 is shown as being placed on the hand, forearm, upper arm, or neck. Additionally, if a compression cuff is used, for example, when device 230 is placed on the hand, compression cuff 2801 is positioned proximal to housing 2700 and injection assembly 2900 to manage blood flow to the puncture site.

[0055] 5A-5D illustrate exemplary directional movements of the housing 2700 of the device 230 of FIG. 4G. FIG. 5A illustrates the device 230 with an integrated compression cuff 2801 that communicates via a wired connection 2802. FIG. 5B illustrates how the housing 2700 and inserter assembly 2900 can rotate relative to the body 2800, such that the inserter assembly rotates along arc R. This ability to rotate, along with the ability to move the housing 2700 within the aperture 2804 in the x, y, and z directions as described above, provides an infinite number of possible locations for the inserter assembly 2900 within the aperture 2804, two such locations being shown in FIGS. 5C-5D.

[0056] In another embodiment, FIGS. 6A-6B show another embodiment of device 130″ similar in shape to device 130′ of FIG. 4F , but with the aforementioned x-direction movement (e.g., side-to-side) substantially eliminated, such that housing 1700″ can pan only in the y-direction within aperture 1804″. Additionally, device 130″ includes strap aperture 1809″ within strap 1808″ through which a portion of base 1800″ (or housing 1700″ or other structure) can advance, thereby providing housing 1700″ with an additional direction of movement. Thus, as shown in FIG. 6B , housing 1700″ can advance in the x-direction (i.e., X-pan), in the y-direction (i.e., Y-pan), and rotate along an arc (i.e., spin). The ability of housing 1700" to move in each of these directions, much like housing 2700 of Figures 5A-5D, allows for an infinite number of possible locations for housing 1700" (and inserter assembly, if present) relative to the patient.

[0057] 7A-7B show further embodiments of devices 330, 330′ including a monolithic body and housing 3800, 3800′ and an inserter assembly 3900, 3900′ that can move relative to the body / housing 3800, 3800′. For example, in FIG. 7A , assembly 3900 can be movable relative to body / housing 3800 via one or more micro-motion mechanisms 3950 to enable delicate movement of assembly 3900 relative to the patient's anatomy. Similarly, shown in FIG. 7B , assembly 3900′ can be connected to body / housing 3800′ via a ball-joint mechanism 3950′ that can also provide movement of assembly 3900. Either mechanism 3950 or 3950′ can enable movement of assembly 3900, 3900′ in any of the “XYZRTD” directions (as defined below) and can provide such movement in small increments.

[0058] 1A-6B provide a relatively large amount of movement, while the devices 330, 330′ of FIGS. 7A-7B are intended for a relatively small amount of movement. Accordingly, these devices may be used in different ways. For example, the device 330, 330′ would be placed after the puncture site has already been determined (using the body / housing 3800, 3800′ or by another device); thus, the device 330 would not be secured to the patient until the puncture site is precisely determined. Alternatively, the other devices described above may be placed in the general area where a puncture site is desired, such device then secured to the patient, and the housing and / or inserter assembly may then be moved to find the desired puncture site. Of course, any of the devices described herein may include a combination of these movement features, such that, for example, a device may have the capability of both relatively large movements as well as relatively small movements (i.e., relatively large movements may be used to find the puncture site, and then relatively small movements may be used to navigate the needle tip to and through the puncture site).

[0059] Returning to the optional compression cuff, FIGS. 8A-8C show various locations of the optional compression cuff 2801 relative to the device (i.e., housing / body). The variations shown are possible locations, but any other location of the compression cuff relative to the housing / body of the device is envisioned. Similarly, a wireless 2801' (or otherwise not physically connected) compression cuff 2801, such as that shown in FIGS. 8D-8E, may also be positioned any distance relative to the housing / body 230 as desired.

[0060] 105, a support 24000 according to another embodiment of the present disclosure is shown. The support 24000 includes a compression cuff 24004 with an integrated strap for adjusting tension of the cuff. A window 24006 is provided for receiving a pad 24002. Various devices, including a visualization device and an inserter assembly, can be docked to the window 24006.

[0061] Various other types of straps may also be used with any of the aforementioned devices, some of which are disclosed and described in further detail below. Furthermore, instead of simply a single base and a single housing, the devices of the present disclosure may include multiple housings, each capable of performing a distinct function or portion of a desired function.

[0062] 21A and 21B show device 40 according to another embodiment of the present disclosure. Device 40 is generally similar to device 20, but includes straps 508' that extend through an outer frame 502', as best shown in FIG. 21A. This configuration allows a pre-injection patch 700' to be placed over straps 508' (FIG. 21B) or under straps 508' (not shown). Straps 508' can be used to secure the pre-injection patch 700' when straps 508' are placed over the pre-injection patch.

[0063] Referring now to FIG. 22 , a device 50 according to another embodiment of the present disclosure is shown. Device 50 is generally similar to device 50 but includes multiple modules that interface with an outer frame 502′. A venous preparation module 500A is attached to outer frame 502′, which is attached to the patient by straps 508′. The venous preparation module 500A aids in determining the vein versus the (typically less compressible) artery. The venous preparation module 500A can also perform a vibrating or tapping motion to stimulate the vessel to become more optimal, expand more, and / or rise closer to the skin's surface for more cannulation conditions—i.e., to increase the lumen size and make it easier to target. The venous preparation module 500A can be replaced with an imager module 500B to examine the vasculature and identify ideal injection sites. Finally, a cannulation module 500C can be coupled to outer frame 502′ to place the needle in the prepared and predetermined vein. Although a device having three modules for needle insertion procedures is described here, other embodiments may have two, four, or more modules specifically configured for other procedures.

[0064] Various strapping configurations according to another embodiment of the present disclosure are shown in Figures 23A-23C. Figure 23A shows strap 608, which can be applied underneath base 100. Strap 708 extends through base 100, as shown in Figure 23B. Strap 808 can be placed above base 100, as shown in Figure 23C. The required strapping configuration can be selected depending on the securement required to attach the device to the patient.

[0065] In another embodiment, an automatic tightening strap 1008 is provided, as shown in FIGS. 24A-24C. The automatic tightening strap 1008 is configured to automatically tighten around an accessory, as indicated by directional arrow 1009, to secure the device. The automatic tightening strap 1008 can be adjusted to tighten to a desired tension to provide precise tension during medical treatment. Because the automatic tightening strap is a self-tightening strap, no action from the operator is required to secure the device to the accessory. As best seen in FIG. 24C, the automatic tightening strap 1008 allows the device to automatically adjust along the axis of fixation 1110 to find the ideal location for the device.

[0066] 25A-25I, various embodiments of straps of the present disclosure are shown. Strap 508A shown in FIG. 25A may be worn by the patient, allowing an operator to attach housing 100 prior to needle insertion. After needle insertion or other procedure is complete, housing 100 can be easily detached from strap 508A, leaving strap 508A at the surgical site. Attached strap 508A can be reused to access the same surgical site, if desired.

[0067] 25B includes one or more self-tightening compression cuffs 509B that can automatically tighten around a vein to block venous blood flow during needle insertion.

[0068] 25C shows a strap 508C according to another embodiment of the present disclosure. The strap 508C is configured as a sleeve that can be attached to a patient's appendage, such as an arm or leg. The housing 100 can be attached to the strap 508C via an opening 509C on the sleeve or a side slot 510C. The strap 508C can be made of polyester, spandex, or the like to form an unobtrusive sleeve that can be coupled with the patient's body.

[0069] 25D illustrates a strap 508D according to another embodiment of the present disclosure. The strap 508D is configured to secure the housing 100D, which has a slot 509D for receiving the strap. The strap 508D can be slid over the housing 100D, onto the slot 509D, as shown in FIG. 25D, to secure the housing 100D to the strap.

[0070] 25E illustrates a strap 508E according to another embodiment of the present disclosure. The strap 508E includes a weight 509E that secures the housing 100 to the target surgical site. The operator can place the housing 100 at the surgical site and allow the weight 509E to freely hook onto either side of an accessory. Thus, the housing 100 can be securely attached to the surgical site using only the weight of the weight 509E.

[0071] Referring now to FIG. 25F, a strap 508F according to another embodiment of the present disclosure is shown. The strap 508F is configured as a foldable body having wings that wrap around the housing 100 when the device is not in use. Thus, the strap 508F can be conveniently unfolded to extend laterally from the housing 100 for attaching the device to a patient, as shown in FIG. 25F. A bandage or other fastening means can be added to the strap 508F to enhance attachment of the strap to the patient.

[0072] 25F-25I show a strap 508G according to another embodiment of the present disclosure. The strap 508G includes one or more compression cuffs 509G that can be opened (FIG. 25H) and closed (FIG. 25I) by a clamp 510G. After the ideal surgical location is identified by the housing 100, the clamp 510G can be locked to secure the device at the target location, as shown in FIG. 25I. While a clamp is shown in this embodiment, other securing means, such as fasteners, brackets, grips, etc., can be used.

[0073] FIGS. 26A and 26B illustrate embodiments of the attachment means of the present disclosure. FIG. 26A shows a housing 100 having a bandage layer 702 attached to its distal end. The operator can peel off the bandage layer 702 and securely attach the housing 100 to the desired surgical site, as shown in FIG. 26A. FIG. 26B shows a housing 100 having a suction layer 704 on its distal surface with a plurality of holes 705. A suction-creating means (not shown) creates a vacuum to allow the housing 100 to be securely attached to an accessory. The housing 100 can be easily detached and removed from the surgical site by turning off the suction. The attachment means 702 and 704 allow for secure placement of the device without strapping it to an accessory; therefore, these attachment means may be particularly useful when performing procedures with the device on children.

[0074] 27 shows a device 60 according to another embodiment of the present disclosure. Device 60 includes slots 61 to allow an operator to place their fingers within the slots and securely hold the device at the target surgical site. Thus, device 60 does not require attachment or fixation means, as the operator can simply use his / her fingers to hold and secure device 60 during the procedure.

[0075] Additional and alternative embodiments are also shown in Figures 28-33 of this disclosure.

[0076] Building the device As shown in Figures 1A-2E, in certain embodiments, the devices of the present disclosure may be constructed primarily as a single unit. Specifically, the device may be constructed as a single housing containing the various functional elements discussed herein. For example, the housing may be separable from the base such that the base may be placed on the patient first, and then the housing may be placed on the base. However, in other embodiments, the housing and base may also be a single, monolithic unit such that the entire device is placed on the patient at one time.

[0077] Additionally, regardless of the configuration of the device's housing and base, the inserter assembly may be separable from the housing and base, for example, such that once the base and housing are in place (whether as a single unit or as individual nestable units), the inserter assembly may then be inserted into the device for subsequent use on a patient. Additionally, providing a needle that can be nested with the device while it is already in place may allow for increased flexibility in function, as the operator can select the appropriate size and shape needle for the selected vessel.

[0078] In one embodiment, the housing is a reusable element. This is beneficial because the housing will contain various electronics and other higher-cost components. The base can also be reusable, or alternatively, the base can be made of low-cost polymers, textiles, paper-based materials, etc., so as to be disposable. As such, in one example, a new base would be used for each patient, with the reusable housing being connected to each new base. Reusable housings can also be serializable and / or capable of withstanding known methods of high-level disinfection, such as hydrogen peroxide chambers, vacuum cleaning systems, and / or submersible (e.g., IP67 or higher) for immersion or processing via other cleaning systems, e.g., steris, etc. The housing may be rigid, have zero or near-zero internal air voids, and / or include hermetic seals to prevent ingress of liquids and / or gases. The housing 100 can be reusable, allowing the housing 100 to be docked to a new base 200 for every insertion procedure; however, for example, the base 200 shown in FIGS. 1A-1B can be disposable. Alternatively, the base 200 can be sterilized and used for a predetermined number of applications, after which it can be replaced. A reusable base can also be attached to a visor 700, which can be renewed for each use, thereby protecting the base from contamination, particularly during initial placement and positioning of the desired puncture site. A sterile barrier other than or in place of the visor can also be added around the base and removed immediately before final placement. Such a removable sterile barrier can be particularly useful when the device will navigate a relatively large area of ​​skin prior to puncture site selection, so that sterilization of a large skin area is not required. For example, the sterile barrier can be a flexible plastic film that can be detached, peeled, or the like from the base when the puncture site is selected.

[0079] In another embodiment, the needle and base may be packaged together as a kit. Optionally, a visor 700 may be disposed on the base to hold the needle together with the base. For example, as shown in FIGS. 1A-1B , the visor may encompass at least a portion of the aperture 204 and may include a recess or other engagement feature to maintain the needle or inserter assembly 300 in place relative to the aperture for simplified retrieval of the needle by the housing. After the housing is attached to the base, the needle may then be attached to the housing or otherwise maintained in place relative to the base and housing. Optionally, the visor may automatically drop upon engagement of the base to the housing—for example, when the housing mates with the base and inserter assembly, the inserter assembly may push down on the aperture to move the visor away from and release it from the base.

[0080] The housing can include any desired elements, and as mentioned above, the housing can be reusable, thus housing various electrical and mechanical components. For example, the housing can include a graphical user interface ("GUI") to display 3D scanned dynamic and static images of the puncture site venous insertion point, servo motors for needle insertion and retraction, etc. The GUI will be included in semi-autonomous devices, while autonomous devices may or may not include a GUI. Alternatively, either autonomous or semi-autonomous devices may include an external GUI rather than a GUI as part of the housing. As shown throughout this specification, various device embodiments contemplated herein are small enough to be portable and can be carried by an operator. While certain devices, such as those shown in FIGS. 1A-4F and 6A-6B, are generally rectangular, devices can be assembled in other shapes, such as those shown in FIGS. 4G-4I and 5A-5D, as discussed herein. Additionally, the various devices disclosed herein can be assembled in different sizes and can have molded shapes for specific applications, examples of which are discussed herein.

[0081] The base portion of the device can be made of a rigid or flexible material. For example, if the desire is for the base to be usable in a variety of anatomical locations, the base can include a flexible component that can fit over anatomical structures to configure a particular geometry. Additionally, alternative engagement features can be included in kits that include the base, such as snap features, straps, bandages, or other similar attachments to provide flexibility in attaching the device to the patient.

[0082] The device may also be made available as a kit. In one embodiment, the kit includes at least one base, at least one strap, at least one insertion assembly with various needle and component combinations for different applications, at least one protective visor, and at least one or a range of connecting gel pads. A compression garment may also be included in the kit and used in conjunction therewith, for example, to facilitate identification of the vein and puncture site location and to stabilize the skin surface during insertion. Such a kit may be combined with a reusable housing, or the kit may include at least one new housing for single or multiple uses.

[0083] In another embodiment, the kit includes at least one base and at least one inserter assembly. The kit may also include a housing, or a reusable housing may be used with the kit. In a further embodiment, the kit includes at least one housing and at least one base. The at least one inserter assembly may also be included, or may be supplied separately with at least one or a range of connecting gel pads.

[0084] In any of the aforementioned exemplary embodiments of the kit, each component can be packaged individually or together in a single package. For example, a single package may include one housing and then multiple individually packaged / sterilized bases and / or needles. Additionally, if multiple bases and / or inserter assemblies are in the kit, a single base may be packaged with each inserter assembly as a sterile combination. Any of the aforementioned kits may also include at least one protective visor, at least one compression garment, and / or the like.

[0085] The device may be fully or partially assembled, depending on the specific application. For example, a fully assembled device may be used in an emergency by emergency medical technicians to easily use and establish intravenous access to a patient. A fully assembled device would reduce the number of steps required to perform a needle insertion procedure in an emergency. Such a fully assembled, ready-to-use device may be useful in emergency rooms, battlefield and field hospitals, ambulances, etc. Alternatively, a partially assembled device may provide greater flexibility and be used in a wider range of applications by allowing the operator to customize the device for a specific application. Such a partially assembled device may be useful in operating rooms, blood banks, laboratories, clinics, etc.

[0086] In one embodiment, the device includes a wafer-like shaped sensor structure integrated with a protective housing that may include ergonomic aids and operational controls, e.g., manual controls, a graphical user interface (GUI, also referred to herein as a display), etc. Additionally, other external features may be included that can aid the user in the cannulation process, for example, by providing subsurface imaging capabilities, needle or cannula tracking, etc.

[0087] In one exemplary embodiment of a method of use, as shown in FIGS. 65A-65B, a user grasps device 4000 and places it on or over a patient's skin 4002. As described below, device 4000 includes a sensor or sensor array 4004 to probe the patient's anatomical structures below the skin to locate a suitable blood vessel, as shown in FIG. 65A. Locating a suitable blood vessel also determines a desired puncture site 4008 on the skin surface, thereby placing needle 4006 into the skin at the puncture site, ultimately entering the desired blood vessel. Device 4000 can then track needle 4006 as it approaches puncture site 4008, as shown in FIG. 65B. The user then manipulates needle 4006 into and through the skin at the puncture site, as shown in FIGS. 65C and 65D. Once inside the patient, the needle tip 4010 is tracked using the device's sensor / sensor array 4004 to observe the needle tip as it approaches the blood vessel and prompt the user to direct the needle tip into the blood vessel, as shown in Figure 65E. Once the needle tip 4010 is in the blood vessel, the blood vessel is said to be cannulated, and the user can proceed to perform the desired procedure.

[0088] 66A-66E show various example locations where the device 4000 disclosed herein may be used on a patient, such as the hand (FIGS. 66A and 66E), the arm (FIG. 66A), the neck (FIG. 66B), the foot (FIG. 66D), etc. While these illustrated locations are commonly known as the primary locations for cannulation of the circulatory system, other locations on the body may also be desirable locations for using these devices and are also envisioned.

[0089] The following exemplary physical embodiments and sub-variations of such devices are hereby presented: While certain embodiments may exhibit certain features, components, and / or functions, it is understood that any of these features, components, or functions may be incorporated into any of the other exemplary embodiments in any desired or useful combination or configuration.

[0090] 67A-67C, a substantially flat, rectangular device 5000 is shown in accordance with one embodiment of the present disclosure. A bottom surface 5014 is at least partially or completely covered by an imaging sensor 5004. As shown in FIG. 67B, the device 5000 is sized to be manipulated by a user's hand. The opposite side is formed at least partially or completely by a display screen 5012. The display screen may also be or incorporate a GUI or have other control capabilities to allow a user to interface with the device.

[0091] 67C shows a cross-sectional view to reveal the components of device 5000 of the present invention. As shown, the device includes a display 5012 on top, and an imaging sensor such as a CMUT 5004 or any other sensor may be used or combined with a CMUT, a battery 5016, and a main pcb (printed circuit board) 5007 and a camera pcb 5005. As mentioned above, a PMUT sensor array may be used in place of a CMUT array.

[0092] Housing 5009 is shaped to accommodate placement by a user's hand and also includes cutout 5011 to provide an improved shape for placement of needle or cannula 5006. Specifically, cutout 5011 may serve to allow the needle or cannula to better access the anatomical structure being viewed on the display—in other words, the needle may reach near a portion of a blood vessel shown on the display.

[0093] 67B, the device 5000 may also include the capability of marking 5013 a recommended puncture site 5008 for initial insertion of the needle or cannula into the skin. For example, a laser, camera, focused light (e.g., LED), or mechanical aiming device may be included to assist the user in locating the best puncture site on the patient's skin.

[0094] Optionally, the device may include a pad or other intermediate layer that can be placed between the bottom surface of the device and the skin. For example, the pad may be formed of a conductive gel to enhance visualization. The pad may also provide sterilization, marking / targeting, or other functionality to the device. Additionally, the device may be reusable, while the gel pad may be disposable.

[0095] 68A-D, a device 6000 according to another embodiment of the present disclosure is shown. Device 6000 is generally similar to device 5000, and therefore similar elements are referenced by similar numerals in the 6000 series. Device 6000 in this embodiment includes an extension brick with a low-profile, fixed ergonomic aid at one end. The ergonomic aid may be a clip 6014 that doubles as a pocket clip for convenient user carrying. As shown, the device is sized to be carried in a pocket. Optionally, device 6000 may also include a charging coil 6017 for wireless charging, or device 6000 may include an adapter for wired charging.

[0096] 68C shows a cross-sectional view of device 600 including CMUT 6004 as a sensor, display 6012, and PCB 6007. Optionally, the device may also include a charging coil for wireless charging, or alternatively, the device may include an adapter for wired charging. Optionally, the device may also include a laser, camera, etc. to aid in locating the puncture site 6008 on the patient's skin surface.

[0097] 69A-C, device 7000 according to another embodiment of the present disclosure is shown. Device 7000 is generally similar to device 5000, and therefore similar elements are referenced with similar numerals within the 7000 series. Device 7000 has an ergonomic handle 7026 that is rotatably positioned to aid a user in manipulating the device. Handle 7026 is foldable for storage, as shown in FIG. 69A, and can be lifted slightly when undeployed to double as a pocket clip for convenient carrying.

[0098] 70A-C, device 8000 according to another embodiment of the present disclosure is shown. Device 8000 is generally similar to device 5000, and therefore similar elements are referenced with like numerals within the 8000 series. Device 8000 includes a telescopically deployed ergonomic knob 8026 to assist the user in manipulating the device. Knob 8026 allows for two-finger control of the pressure / angle / traction of device 8000. Optionally, knob 8026 can be biased in the undeployed position so that it "clamps" onto the user's finger for improved stability during use.

[0099] 71A-D show device 9000 according to another embodiment of the present disclosure. Device 9000 is generally similar to device 5000, and therefore like elements are referenced with like numerals in the 9000 series number. Device 9000 includes raised "beveled" areas 9028 on either end of the device that can assist the user in pressing and sliding the device over the skin. Beveled ends 9028 may also include an additional layer of friction-inducing material, such as a co-molded polymer, e.g., a thermoplastic elastomer (TPE).

[0100] 72A and 72B show device 10000 according to another embodiment of the present disclosure. Device 10000 is generally similar to device 5000, and therefore like elements are referenced with like numerals in the 10000 series. Device 9000 includes a two-piece structure joined near one end with a hinge 10030, which may be rigid (such as a spring, door hinge, etc.) or semi-flexible (such as a living hinge, resilient material, etc.).

[0101] Each piece can be slimmer than the single-piece embodiment described above, and various components of the device can be placed within one of the pieces; one such configuration is shown in FIG. 72A.

[0102] The two-piece construction allows the user to slide device 10000 onto the lip of a pocket for convenient carrying, as shown in FIG. 72B. Teeth 10032 may allow the device to engage the lip of a shirt pocket (or other structure to which the device will be clipped) by sliding the curved surfaces of the teeth against the lip, moving the lip between the two pieces and engaging therewith.

[0103] 73A and 73B show a device 10100 according to another embodiment of the present disclosure. Device 10100 is generally similar to device 10000, and thus similar elements are referenced with like numerals in the 10100 series. Device 10100 includes a two-piece structure joined near one end with a hinge 10130, which may be rigid (such as a spring or door hinge) or semi-flexible (such as a living hinge or resilient material). The hinge may be biased to hold the two layers together. Hinge 10130 is on the inboard side of device 10000, so a user can more easily grasp the hinged end and separate the two pieces to easily clip onto a pocket or other structure, as shown in FIG. 73B.

[0104] 74A-74C show a device 10200 according to another embodiment of the present disclosure. Device 10200 is generally similar to device 10100, and therefore, like elements are referenced with like numerals in the 10200 series. Device 10200 includes a two-layer structure in which the two layers can be joined in a configuration via an extendable post 10232. Post 10232 can be telescopic or longitudinally extendable, as shown in FIG. 74C, and can have a pivoting or hinged relationship with the two layers, as shown in FIGS. 74A and B. Post 10232 can be internally biased to bring the two layers together, so that a user can engage the opposing curved edges of the two layers, wedging their fingers between them, and separating them, as shown in FIG. 74B. The biasing action allows device 10200 to actively grip the user's fingers for stability during use. Alternatively, the post 10200 may include a ratchet mechanism to maintain a user-controlled gap. For example, the two layers may be spread apart, and when the user places a finger between the layers, the layers may be moved back toward each other along the ratchet, positioning (holding) the layers in a position that comfortably secures them against the finger. In the aforementioned variation where the layers are biased toward each other, the post may incorporate an absorbent material capable of slowing the movement of the layers toward each other.

[0105] Similar to any of the embodiments disclosed herein that include either a biasing or ratcheting portion, or a tab or other handle, and further, such a structure can allow a user to secure the device to the user and allow the user to lift the device off the patient's skin without having to further grasp the device, so that such a structure can enable a stable connection of the user to the device during use. Similarly, in such cases where the device is securely attached to the user's finger, it can be easier to simultaneously apply counter-traction on the patient's skin with the thumb (since the thumb is not required to hold the device), which can help stabilize the vein and further help prevent the user from accidentally dropping the device.

[0106] 75A-75C show a device 10300 according to another embodiment of the present disclosure. The device 10300 is generally similar to the device 5000, and therefore, like elements are referenced with like numerals in the 10300 series number. Similar to the other exemplary embodiments described above, the device 10300 includes a cutout 10336 where the needle 10306 can enter the skin. As shown in FIG. 75B, the cutout 10336 may be of any desired size to expose the puncture site 10308. Sensors located on two legs 10337 of the device, on either side of the cutout 10336, can detect the area of ​​the patient within the notch for better imaging of the needle 10306 as it first enters the skin at the puncture site 10308.

[0107] Additionally, the inner surface of cutout 10336 may be fitted with a camera, metal sensor or other above-surface sensor for better imaging of the needle before and / or as it first enters the skin at the puncture site.

[0108] 76A and 76B, a device 10400 according to another embodiment of the present disclosure is shown. Device 10400 is generally similar to device 5000, and thus similar elements are referenced by similar numerals in the 10400 series. Device 10400 includes a sensing layer 10404 to be disposed adjacent to or on the patient's skin, and a display 10412, with the sensing layer positioned at an angle relative to the display. Such placement of the display can provide a display screen that is at a more perpendicular angle to the user's eyes, thereby enabling improved and more accessible viewing, particularly in cases where the user is sitting in a chair next to the patient or otherwise positioned to the side of the puncture site and device. The angle may be any desired angle, for example, between and including about 1 degree and about 90 degrees.

[0109] A user can place their finger on the sensing layer 10404, resting on the ergonomically textured 10440 ( FIG. 76A ) and / or concave or recessed surface 10442 ( FIG. 76B ). The textured grip surface 10440 may be formed by a high-traction material (e.g., a high-friction rubber pad). Note that FIG. 76B is cut away to show the CMUT sensor 10404 (or other sensor). The device 10400 may further include a notch 10411, which may provide space for a needle to access a puncture site that may be positioned near the CMUT sensor array 10404, similar to the other notches and cutouts described above.

[0110] 77A-77C show a device 10500 according to another embodiment of the present disclosure. Device 10500 is generally similar to device 10400, and therefore like elements are referenced with like numerals in the 10500 series. Device 10500 includes a sensing layer 10504 and a display 10512 that are angled relative to one another. The device of this embodiment also includes a tab 10548 (placed on top of the sensing layer, as shown) on the device for engagement by a user. Thus, a user can place their finger between the layers, where the ergonomic tab aids the user in operating the device.

[0111] 77B and C, the tab 10548 may be foldable for ease of storage or to expand the possible ways to use the device. As previously mentioned, the tab may be telescoping or otherwise expandable and may be biased toward a particular position, e.g., a collapsed position.

[0112] 78A-78C show a device 10600 according to another embodiment of the present disclosure. Device 10600 is generally similar to device 10500, and therefore similar elements are referenced by similar numerals in the 10600 series. Device 10600 includes a sensing layer portion 10604 and a display portion 10612, which are connected via a hinge 10652, which may be rigid (such as a spring, a door hinge, or the like) or semi-flexible (such as a living hinge or a resilient material). Hinge 10652 may be biased to hold the two layers together. Alternatively, the hinge may include a pawl that will maintain the two portions at a fixed angle relative to one another.

[0113] In use of device 10600, the portions can be separated by the user inserting one or two fingers of their needle-free hand into the space between the portions, or by retracting one portion from the other and then inserting one or two fingers between the separated portions.

[0114] In a biased hinge alternative, the two sections can clamp snugly around the fingers. Optionally, the hinge can be damped so that the clamping action is slow and controlled. Conversely, a ratcheted hinge variation can clamp the sections around the user's fingers to position the device snugly on their hand. Additionally, the inner surface of each section can include grip 10654 or other ergonomic materials / shapes to provide additional stability to the device during use. For example, a soft, high-traction material can help secure the device to the fingers. The hinge can have the ability to achieve any desired angle between and including 0 and 180 degrees, for example, between and including approximately 1 and 90 degrees.

[0115] 79A-H show various embodiments of a notch 5011 or other targeting feature used to provide access to and / or provide guidance of the needle 5006 to the puncture site 5008. For example, FIG. 79A shows an exemplary targeting device, i.e., laser 10700, spotlight, etc., that highlights 10702 the desired puncture site 5008. The location of this light 10702 on the patient's skin can be constant and fixed relative to the device, or alternatively, can be movable based on the device's software and its understanding of the patient's underlying anatomy.

[0116] In another embodiment shown in Figure 79B, the mechanical indicator 10800 is represented as at least one and three physical markers shown pointing towards a central location 10802 in the notch of the device. A user of the device can utilize these markers to direct the needle towards the skin within the notch - and the puncture site 5008 found therein.

[0117] 79C, the device can include a light-based targeting device 10900 whereby the puncture site 5008 is indicated on the skin with projected illumination 10902 (e.g., a laser dot, a projected light aiming line, a laser line, etc.). Placement on the patient's skin can be constant and fixed relative to the device, or alternatively, can be movable based on the device's software and the device's recognition of the patient's underlying anatomy.

[0118] 79C , but as shown, the projected illumination 11002 also includes a line 11004 projected by the device onto the patient's skin. The line can further help the user align and aim the needle along a precise XY path before the needle touches the skin at the puncture site 5008.

[0119] In another embodiment, as shown in FIGS. 79E-G, the device 5000 may include connectivity capabilities 12002, e.g., Bluetooth, for wirelessly connecting to a needle element 12004. The needle element may be attached to the needle 5008 or integrated into the needle and wirelessly connected to the device (e.g., Bluetooth-enabled). The needle element 12004 may be an accelerometer or gyro, or other sensor device. In the example of an accelerometer or gyro, the accelerometer can ascertain the location of the needle 5008 relative to the device. Through the Bluetooth connection, the device can ascertain the intended needle direction axis, the intersection of that axis with the surface of the skin (and specifically the puncture site), etc., and such information may be used to generate an image and / or needle location data for the display of the device (as described above). The needle element 12004 may simply clip onto the needle 5008, as shown in FIGS. 79E and F, or it may have another attachment mechanism for securing it to the body of the needle.

[0120] In another embodiment, shown in FIG. 79H, the device includes at least one sensor 13002 above the skin (e.g., below the screen or on the inner surface of the leg around the cutout, as shown) that can determine the location and axial angle of the needle tip 5010 before the needle tip touches the skin. These sensors may be visual / camera-based, or detect the metal of the needle (e.g., via magnetic force), etc. A virtual representation 13004 of the needle may appear on the screen before the needle is inserted into the skin, so that it may be virtually XY-aligned with the subsurface vein that appears on the screen (even though the actual tip of the needle is not clearly visible from the user's direct line of sight). After passing through the puncture site, the needle, once under the skin, is visible on the screen via other sensors in the device, such as a CMUT sensor.

[0121] Any of the aforementioned devices may also include a pad or other intermediate layer that can be placed between the bottom surface of the device and the skin. One example of such a pad 14000 is shown in FIGS. 80A-C. For example, the pad may be formed of a conductive gel 14004 to enhance visualization. A peel-away cover 14002 can protect the gel 14004 prior to use. The pad may also provide sterilization, marking / targeting, or other functionality to the device. Additionally, the device may be reusable, while the gel pad may be disposable. The layers may be peelable, allowing the operator to remove used layers and reuse the pad or remove unnecessary layers to customize the pad according to the patient's specific needs.

[0122] Navigation / imaging As mentioned above, the device of the present invention includes various functionalities suitable for semi-autonomous or autonomous use, such as locating a puncture site on a patient and inserting a needle into the device. Regarding the puncture site locating function, the device may include navigation capabilities to aid in internal visualization to locate the puncture site. Navigation capabilities can examine the patient's anatomy in search of the desired blood vessel. For example, navigation may include sensors utilizing ultrasound, X-ray, infrared ("IR"), near-infrared ("NIR"), diffuse IR, acoustic, optoacoustic, photoacoustic, light-emitting diodes ("LEDs"), CMUT, polarized LEDs, video cameras, transillumination, or other technologies. Sensors using different technologies may also be combined into a single device. For example, a transillumination sensor can serve as a first visualization tool to quickly provide preliminary visual data of the general vein location, then allowing the operator to position the device across the general vein location and use a secondary sensor to define and precisely point the puncture site. The secondary sensor may be an ultrasound sensor, which will provide precise and detailed imaging information. The dual sensor approach optimizes navigation performance by balancing speed and accuracy. Regardless of the sensor type, the navigation sensor can be fully portable in an autonomous device with six degrees of freedom, allowing the device to automatically scan a patient's skin area once it is placed thereon. Semi-autonomous devices can have fixed or partially portable navigation sensors. For example, a semi-autonomous device with an ultrasound navigation sensor can include first and second lateral arrays of ultrasound transducers to map veins in 3D.

[0123] The navigation output may be communicated to the operator visually, audibly, or tactilely. The visual display may be provided via the device's GUI or transmitted to a remote display screen, which may show a three-dimensional mapping of the vascular and general subcutaneous conditions at the puncture site. This mapping may include dynamic (real-time) and / or static imaging as desired. For example, real-time imaging may be acquired at the puncture site to monitor insertion by placing a navigation sensor directly in the field of view of this area, while static imaging may be used to generate a map of a larger area to improve visual feedback to the operator. The visual display may also be projected directly onto the skin surface, indicating the puncture site with reference to the mapped vein, and may be augmented with a laser or other light projection as a puncture site guide. Image magnifiers, contrast resolution adjustments, and other image optimization features may also be included to enhance the visual feedback. Additionally, audible and tactile output feedback may also be integrated with the visual display to improve the user interface. For example, an audible signal may also be incorporated into the device and used in conjunction with the visual display to further aid in accurate locating the puncture site. For example, as described above in the dual sensor approach, the output of the first sensor can be communicated solely by an audible signal, thus allowing the operator to quickly narrow down the puncture site for the second sensor to scan without visual display feedback.

[0124] Navigation capabilities would include the ability to identify not only the location and depth of veins below the skin, but also other important aspects of blood vessels and blood flow. For example, Doppler ultrasound could be used to detect and display blood flow direction and conditions. This would allow the operator to distinguish between arteries and veins based on flow direction and evaluate blood flow conditions such as velocity, pressure, and temperature to accurately identify the puncture site autonomously. Alternatively, the device could process this information to identify and direct the operator to the puncture site in a semi-autonomous manner. A nerve monitor could be included in the device to detect the proximity and location of nerves and to ensure the puncture site and trajectory are away from them. Venous valves and branching points could be identified and evaluated in determining the ideal puncture site.

[0125] The device may also have secondary sensors to provide feedback during needle insertion, needle fixation, and needle retraction. For example, a force sensor on the device can relay data regarding the success of needle penetration and supplement the visual feedback obtained from other sensors. Force and tactile sensors may be particularly useful in procedures for accessing wrist veins and other similar venous locations, providing tactile feedback to avoid excessive insertion force that would force the needle through the vein.

[0126] Additionally, velocity or pressure sensors may be coupled to the device to allow the operator to ensure that the needle remains firmly in place after insertion. For example, if the needle is inadvertently removed from the blood vessel after insertion, these sensors can detect changes in blood flow velocity or pressure and alert the operator.

[0127] Although the navigation capabilities disclosed herein are generally discussed with reference to the circulatory system, these capabilities may also be used in subcutaneous and intraosseous needle injection procedures. Similar navigation systems may be used for such procedures.

[0128] In certain locations on a patient's body, target vessels may be located in relatively extreme locations, such as particularly deep and / or very shallow. For example, the anatomical structure of the hand includes blood vessels in these locations, specifically superficial and extremely close to the skin surface. To create additional depth of view for these shallow veins, the housing and imaging system may be further removed from the skin surface by using a thicker connecting material or an expanding or distending connecting material. The connecting material may include a hydrogel or another water-based substrate suitable for transmitting ultrasound with minimal loss or distortion. The connecting material may be manually variable, for example, by selecting a thicker or thinner connecting pad depending on the depth of the vein. The thickness or properties of the connecting material may also be compressible or dynamically adjustable, driven by a motor, pump, thermal conduction, or the like, which causes the connecting material to expand or change shape. Alternatively, the connecting thin film may include shape memory functionality, such as a stretchable supramolecular hydrogel.

[0129] While the use of certain devices described herein, such as devices 10 and 20, allows the housing 100 and 400 to be moved across the skin surface by an operator, certain embodiments do not have this capability for various reasons. For example, in addition to the various sensors discussed herein, in some cases, the navigation system may also have the capability to mechanically move the housing along the skin surface. For example, the previously described device 30 of FIGS. 3A-3B includes a base 800 that is fixed to the patient to prevent it from moving. Thus, the housing 700 includes the capability to move relative to the base 800 to scan along the patient's skin to locate the puncture site. This ability to move the housing 700 may be automated or controlled by the operator using a GUI, etc. The navigation sensors used in this embodiment may be any desired type, as previously described.

[0130] In other embodiments, such as those shown in FIGS. 4A-6B, such devices include a housing capable of moving relative to a base to perform at least navigation functions for scanning a patient's anatomy and determining at least one puncture site. Another example of such a device is shown in FIGS. 9A-9B, where, as shown in FIG. 9E, the illustrated housing 900 can rotate relative to the base 1000 in direction R', such that the housing 900 has at least one degree of movement. The base 1000 may be similar to the bases 200, 500 of FIGS. 1A-2E, but instead of a mounting that prevents the base and housing from moving relative to each other, the base 1000 includes a pivotable connection to the housing 900. After the base 1000 is secured to the patient in a generally desired location and by any desired attachment mechanism (e.g., bandage, strap, etc.), the pivotable connection can enable the housing to scan along the patient's skin surface for at least one puncture site within a general area. As previously mentioned, the navigation functions of the housing 900 can be autonomous or semi-autonomous via an operator interface.

[0131] In addition, Figures 9A-9D and 9G-9I illustrate another capability of this device that can be used in other devices disclosed herein. Specifically, the top surface 901 and at least one side surface 902 or 903 of the housing 900 can include a screen, which can be a GUI, thereby displaying the user's underlying anatomical structure. As shown, the top surface 901 can display a view from above (i.e., from the z direction, as in Figure 9G), while at least one side surface 902 can display a view from the side (i.e., from the y direction, as in Figure 9I). The ability to show two views can provide the user with improved visibility, which can result in more accurate needle placement. Alternatively, one or both of the displays can also show a cross-sectional view (i.e., from the x direction, as in Figure 9H) for additional viewing assistance. Alternatively, any of the displays of the housing 900 would have the ability to switch between any of these views.

[0132] 10A-10E, 11A-11C, 12A-12C, and 13A-13B illustrate additional embodiments of GUIs, if present on the device, through which a user can interact with the device of the present disclosure. The following embodiments are examples of what type of information may be displayed in the GUI, but other variations or combinations of various embodiments are also contemplated. It is further contemplated that the GUI may be tailored to display information desired by a particular operator during manufacture or by the operator prior to use. GUIs according to the present disclosure may include various renderings on the display to facilitate imaging and / or surgical procedures. For example, different colors may be used to represent different body parts, such as veins, nerves, and arteries, to enhance the display of these body parts. Color schemes for representing body parts may be customized or provided according to standard medical practice.

[0133] In one example of such a navigation system, FIGS. 10A-10E show an exemplary GUI of the housing 100. The GUI provides representative images of vessels 1, 2 of the circulatory system, as well as a representation of a needle 301. As depicted in this example, vein 1 and artery 2 are both located and shown in cross section by the navigation capabilities of the housing 100, and needle 301 is then directed toward vein 1 (as described below). As shown, the GUI may also include various navigation aids, such as a ruler on the right hand side. As shown in FIGS. 10D-10E, a GUI may also be placed at the compression cuff to provide information to the user at the compression cuff in addition to, or instead of, the information displayed on the housing GUI itself.

[0134] 11A-11C illustrate another embodiment of the present disclosure, whereby vessels 1, 2, and 3 are shown in a bird's-eye or top view, and needle 301 is represented as an arrow. In this example, three potential puncture sites are designated by dotted lines 11, 12, and 13 along a particular length of each vessel. The GUI in this example includes a box, indicated by dotted line 11 on vessel 1, that designates which location has been selected for needle insertion (as shown in FIG. 11C). In this example, housing 100 includes the capability to determine the depth of location 11 on vessel 1 and to estimate a puncture site (not shown) on the patient's skin surface that may be positioned adjacent base 200. As shown in FIG. 11B, once location 11 has been designated by the selection box, in the case of a semi-autonomous system, an operator can interact with housing 100 to initiate needle insertion. As shown, this interaction can use a button 302 on the GUI, designated as a swipe button 302 in this example, although other forms of interaction are contemplated. 11C then shows the final inserted location of needle 301, shown here as an elongated arrow to indicate the length of needle 301 within vessel 1. As previously mentioned, any desired information, such as battery life, needle gauge, vessel diameter, etc., may also be displayed in the GUI or elsewhere on housing 100 (or in a separate interface).

[0135] 12A-12C show another embodiment of the present disclosure illustrating how the housing 100 may have the ability to switch between multiple views, including, for example, a cross-sectional view ( FIG. 12A ) and a bird's-eye or top-down view ( FIG. 12B ). FIG. 12C is similar to FIG. 11C and illustrates the completion of needle 301 insertion. As discussed above with reference to FIGS. 11A-11C , this embodiment may also include, for example, various information displayed in a GUI, a dotted line 11 designating a recommended insertion location for the needle 301, and a representation of the needle 301 with an arrow ( FIG. 12B ) and an elongated needle ( FIG. 12C ). Depending on the size of the display of the housing 100, the display may provide a split-screen display, for example, such that both a cross-sectional image and a top-down image may be shown simultaneously. Such capabilities can be particularly useful in operator-guided or assisted needle insertion procedures (i.e., semi-autonomous), as multiple screens provide a more intuitive and realistic visual depiction of the blood vessels, thereby enabling the operator to accurately position the needle in the patient's vasculature.

[0136] 13A-13B show a further embodiment of the present disclosure, in which housing 100 includes a GUI capable of displaying an ultrasound image and information overlaid on the ultrasound image. Similar to the graphical representations of Figures 11A-12C, the ultrasound image may include a representation of a cross-sectional view 77 (Figure 13A) and a top or side view 78 (Figure 13B), along with various overlaid information such as dimensions, a ruler, location coordinates, battery life, etc.

[0137] FIG. 14 illustrates one embodiment of how the visual display (GUI) 430 of the present disclosure would use an ultrasound sensor as part of its navigation system. The device's ultrasound image display capabilities can include generating and depicting two-dimensional or three-dimensional views of a patient's anatomy. Two-dimensional images typically allow the operator to switch between cross-sectional and longitudinal (side or top) views, or views can be generated in the x and y directions 431, 432, 433 by including two separate ultrasound scanners within the housing, with the views displayed separately on a multi-view display. Three-dimensional ultrasound images can be generated by incorporating a separate probe in the z direction or, alternatively, by providing the housing with another degree of freedom relative to the patient. The visual display (GUI) may be a generic ultrasound image depicting various regions based on echo intensity, with a white layer of strong echoes and a black layer of weak echoes, whereby the navigation system processes the ultrasound information to generate a graphical color representation of the insertion area, allowing for improved visual feedback.

[0138] Figure 15 provides yet another embodiment of a GUI 530 similar to Figure 14 that can provide multiple views of different surfaces. In this embodiment, the surface of the device is curved so that different views (z-view and y-view as shown, although other configurations are possible) are displayed along different portions of the curved surface. The surface of the device may be a single, continuous GUI, or the GUI may be divided into multiple screen locations along specific portions of the curved surface.

[0139] In a further embodiment, the GUI may have an anti-glare and / or privacy filter to hide or shield the display from the patient to limit or prevent patient anxiety. This application may be particularly useful when the device is being used by children. For example, the device may include two different displays depending on the direction of gaze. For example, from the operator's angle of gaze, the aforementioned anatomical visualization would be seen, while from the patient's angle of gaze, a fun picture would be seen to calm the patient. Alternatively, in embodiments in which the device operates autonomously and therefore such a GUI may not be required, a GUI may be included on the housing so that the patient can view animations, videos, or video games to serve as a distraction during the needle insertion process. In certain instances, the video game or animation may occur simultaneously with the needle insertion process.

[0140] Referring now to FIG. 32 , a visualization device 100′ according to one embodiment of the present disclosure is shown. The visualization device 100′ includes a probe surface 102′, a plan-view display 104′, and first and second depth-view displays 106′ and 108′. As will be described more fully below, the probe surface 102′ includes multiple transducers for generating a two-dimensional image of a volume 10′ representing a target body zone of a patient. The volume 10′ is positioned below a skin surface 12′ and has a length 14′, a width 16′, and a depth 18′ along the Z, X, and Y axes, respectively, as indicated by an orientation reference 11′. As shown in FIG. 32 , the plan-view display 104′ and the probe surface 102′ are substantially the same size as the width 16′ and length 14′, respectively, of the volume 10′. The probe surface 102′ thus defines an area sufficient to generate a two-dimensional image encompassing the volume 10′. Similarly, first depth view display 106' and second depth view display 108' correspond to volume 10'. Other embodiments may have different display screen sizes. For example, displays 104', 106', 108' may be configured to be larger than the corresponding dimensions of volume 10' to provide an enlarged view of volume 10' for improved visibility of the target body zone. Transducers on probe surface 102' may be configured to generate ultrasonic communications to vary the depth 18' depending on the target body zone and the need for visualization of same.

[0141] Although a generally rectangular-shaped visualization device 100' is shown in FIG. 32, other embodiments may have a variety of other shapes, as described more fully below. Similarly, the volume 10' may also have different shapes depending on the probe surface 102' and the transducers disposed thereon. The visualization device 100' may be configured to be a stand-alone device that includes all other components, such as a power source (battery), necessary circuitry to operate the transducers, image processing to combine two-dimensional images generated by the transducers into a three-dimensional view of the volume 10', etc. In other embodiments, the visualization device may be configured to connect to an external power source or a remotely located image processor. The image processor may include an advanced graphics processing unit ("GPU") configured to generate real-time three-dimensional visualizations. A visualization device configured to interface with external components will reduce the overall size and dimensions of the visualization device.

[0142] FIG. 33 shows a visualization device 100′ positioned on a patient's forearm to aid in the cannulation procedure. Volume 10′ overlies the relevant insertion zone, including veins and nerves beneath skin 12′. As best shown in FIG. 34A, plan view display 104′ shows a plan view of volume 10′, including vein 20′, vein branches 24′, and nerve 22′, found beneath skin surface 12′ in real time as the visualization device is positioned on the forearm, as shown in FIG. 33. FIG. 34B shows a first depth view display 106′ showing a depth view of vein 20′, vein branches 24′, and nerve 22′ along the Z and Y axes. FIG. 34C shows a second depth view display 108′ showing vein 20′ and nerve 22′ along the Y and X axes. Thus, visualization device 100′ provides the operator with a real-time three-dimensional view of veins and nerves to enable accurate cannulation. Other details of the target body zone, such as blood flow direction, valves, tissue status, etc., may also be displayed on displays 104', 106', and 108'.

[0143] 35A and 35B, a visualization device 100' is shown positioned at two different locations on a patient's body. As shown here, the visualization device 100' is positioned at two exemplary locations—the patient's biceps and the patient's wrist. Positioning the visualization device 100' at these various body locations may allow the operator to instantly view, in real time, the three-dimensional visualization volume 10' located beneath the visualization device 100'.

[0144] 36A and 36B illustrate a visualization device 200′ according to another embodiment of the present disclosure. The visualization device 200′ is similar to the visualization device 100′, and therefore, similar elements are referenced by similar numerals in the 200′ series. For example, the visualization device 200′ includes a plan-view display 204′ and a first depth-view display 206′. However, the visualization device 200′ includes an attachment device 216′, such as a strap or compression cuff, having a frame 218′ as shown in FIG. 36A . The attachment device 216′ is configured to wrap around the patient's arm or other area. The frame 218′ is configured to removably secure the displays 204′, 206′, 208′ and the probe surface 202′. The visualization device 200′ includes a tracking device 214′ connected to the frame 218′. The tracking device 214' may include multiple tracking elements 217' configured to determine the location of the mounting device 216' in relation to the volume 10'. As such, once the volume 10' is visualized in three dimensions, the tracking device 214' can provide the three-dimensional coordinates of any point within the volume 10'. As shown in FIG. 36B, the displays 204', 206', 208' and the probe surface 202' can be detached from the mounting device 216'. The tracking device 214' communicates the three-dimensional coordinates of the volume 10' in real time via a direct or remote connection 230'. The remote connection mechanism may include Bluetooth, Bluetooth low energy, cellular, Wi-Fi, or other long-range platforms. For example, as the cannula 215' approaches and enters the volume 10', a cannula image 215'' of the cannula 215' is shown in real time on the first depth view display 206'. Imaging or tracking means, such as a video camera, may be used to track the location of the cannula 215 in the volume 10. Thus, the visualization device 200' allows the operator to accurately position the cannula 215' within the patient's vein.

[0145] Referring now to FIG. 37 , a visualization device 300′ according to another embodiment of the present disclosure is shown. The visualization device 300′ is similar to the visualization device 100′, and therefore, similar elements are referenced with similar numerals in the 300′ series. For example, the visualization device 300′ includes a plan view display 304′ and a first depth view display 306′. However, the visualization device 300′ includes a curved screen 320′, as best shown in FIG. 37 . The curved screen 306′ may be rigid, specifically adapted to conform to the body region, or may include a flexible probe surface area 302′ (not shown) to allow the visualization device 300′ to be properly positioned at the target body region. The operator can view the plan view and multiple depth views across the curved display 320′.

[0146] 38A and 38B show a visualization device 400′ according to another embodiment of the present disclosure. Visualization device 400′ is similar to visualization device 300, and therefore, similar elements are referenced with similar numerals in the 400-series numbering. For example, visualization device 400′ includes a curved display screen 420′. However, visualization device 400′ includes parallel vision capabilities, whereby a viewer's location can be tracked by a camera 425′ or other device, such as a sensor, and a corresponding three-dimensional view of the volume can be displayed on curved screen 420′ relative to the viewer's location. For example, when the viewer is at location 422′, camera 425′ tracks the viewer's location and displays plan view 404′ to align with the viewer's field of view 424′, as shown in FIG. 38A. Similarly, when the viewer moves to location 426', camera 425' locates this location and displays a first depth view display 406' on curved screen 420' to align with the viewer's field of view 428', as best shown in FIG. 38B. In one particular example, camera 425' or other sensors can track the viewer's eye movements and adjust the display to account for such movements. The camera or other sensors can also track the viewer's distance from the display and adjust the zoom of the image. Thus, visualization device 400' provides a parallax 3D view across the curved screen display depending on the viewer's location (which may be field of view 422', 426', or anywhere in between). While a curved screen 420' is shown in this embodiment, other embodiments may have a flat display screen with a parallax 3D view, as previously described.

[0147] 38C and 38D show another embodiment of a parallax view on a visualization device 100′. Note that the parallax view concept described herein can be used in conjunction with any visualization device. A viewer located at locations 1, 2, or 3 observes a unique three-dimensional perspective of the volume 10′ specific to each location. For example, when the viewer is located at location 1, the viewer observes a three-dimensional plan-view display 104′ as shown in FIG. 38E. Similarly, when the viewer moves and is located at locations 1 or 2, the viewer observes a three-dimensional third depth view 110′ or a three-dimensional first depth view 106′, as best shown in FIG. 38F and FIG. 38G, respectively. Thus, as described above, following viewer movement, such as the user's eye movement, the display will correspondingly update to provide a visualization specific to the viewer's particular location and movement. The display screens displaying the parallax views may include touch-sensitive screen surfaces, allowing a user to swipe the displays, as shown by directional arrow 121' in FIG. 55, to rotate the view for parallax-enabled depth perception. In another embodiment, the visualization device may display only cross-sectional views on each display. For example, display surfaces 108', 106', and 104' would each display only a cross-sectional view corresponding to each display—i.e., this embodiment may not include a three-dimensional perspective view.

[0148] Referring now to FIG. 39 , a visualization device 500′ according to another embodiment of the present disclosure is shown. The visualization device 500′ is similar to the visualization device 100′, and therefore, similar elements are referenced with similar numerals in the 500′ series. For example, the visualization device 500′ includes a plan-view display 504′, a first depth-view display 506′, and a third depth-view display 510′. However, the visualization device 500′ includes a probe body 511′ having a probe surface 502′ separate from the displays 504′, 506′, and 510′. The probe body 511′ is configured to be disposed in an opening 532′ of a mounting device 516′. The mounting device 516′ may include a base, such as a frame 518′ and straps 534′ as shown, that can be secured to the patient's body. Because the probe body 511' of the visualization device 500' does not include a display screen, the probe body size and dimensions can be smaller than visualization devices that include a display. After the probe body 511' is placed in the opening 532', the probe surface 502' can generate a three-dimensional visualization of the volume 10' and transmit it via the link 530' to the displays 504', 506', and 510' to show a real-time three-dimensional visualization of the volume 10'.

[0149] FIG. 40 illustrates a transducer array 600′ on a probe surface 602′ according to one embodiment of the present disclosure. The transducer array 600′ may be utilized with any of the visualization devices described above. The transducer array 600′ includes transducers 602′ arranged in a grid defining a rectangular pattern having a length 606′ and a width 604′. The transducers 600′ are attached to a substrate 604′. Ultrasound transducers or sensors, such as capacitive micromachined ultrasound transducers (“CMUTs”), ultrasound transducers, piezoelectric transducers, etc., may be used to create the array. Other embodiments may have a combination of CMUTs and piezoelectric transducers, or other such combinations, depending on the particular body region being visualized. When CMUTs are utilized, the substrate 604′ may be a silicon substrate. The CMUTs may be disposed within a cavity within the silicon substrate 604′. The transducers 602′ are configured to switch between transmit and receive modes to generate and capture ultrasound signals. Algorithms can be used to activate individual CMUTs and switch between transmit and receive modes as desired. As best shown in FIG. 40, the projected area of ​​transducer array 600' is substantially the same as the surface area of ​​volume 10' defined by length 14' and width 16'. Thus, a three-dimensional visualization of volume 10' can be generated by placing transducer array 600' in a body zone.

[0150] 41A-41C, the creation of a three-dimensional visualization of a volume 10′ using a transducer array 600′ is illustrated. The active transducer 602″, i.e., a transducer in transmit or receive mode, may include a single transducer, a row of transducers, or the entire transducer array 600′. FIG. 41A shows the active transducer array 602″ generating a two-dimensional image 636′ that captures a two-dimensional slice of the volume 10′. The depth 18′ of the two-dimensional image 636′ depends on the type of transducer 602′ and the power supplied therethrough. Both of these parameters may be appropriately modified depending on the application of the visualization device. For example, low-power transmission via a coarse transducer array may be used to generate a two-dimensional image with little depth penetration, and high-power transmission via a fine transducer array may be used to generate a two-dimensional image with greater depth penetration. The density of transducers 602′ across the transducer array 600′ can be varied to adjust the quality of the two-dimensional image. For example, a high-density transducer array can be used to generate a two-dimensional image with high resolution, while a low-density transducer array can be used to generate a two-dimensional image with low resolution. FIG. 41B shows a second row of transducers 602″ activated to generate a two-dimensional image 636′ at a second location. As previously mentioned, the rows can be activated individually or simultaneously, as shown in FIG. 41C. After generation of the two-dimensional image 636′ across the volume 10, the two-dimensional image collection 638′ is then processed by an image processor housed within or external to the visualization device to produce a three-dimensional visualization of the volume 10′.

[0151] 42 is a transducer array 700' according to another embodiment of the present disclosure. The transducer array 700' is similar to the transducer array 600', and therefore like elements are referenced by like numerals in the 700' series. For example, the transducer array 700' includes transducers 702' aligned on a substrate 704'. However, the transducer array 700' has transducers 702' along the width 16' of the volume 10' to generate a two-dimensional image along the width in some applications, rather than along the length as previously described.

[0152] FIG. 43 is a transducer array 800′ according to another embodiment of the present disclosure. The transducer array 800′ is similar to the transducer array 600′, and therefore, like elements are referenced by like numerals in the 800′ series. For example, the transducer array 800′ includes transducers 802′ arranged on a substrate 804′. However, the transducer array 800′ has transducers 802′ along both the length 14′ and the width 16′ of the volume 10′. This allows the transducer array 800′ to generate two-dimensional images in multiple directions for high-resolution three-dimensional visualization of the volume 10′.

[0153] 44 is a transducer array 900' according to another embodiment of the present disclosure. The transducer array 900' is similar to the transducer array 600', and therefore like elements are referenced with like numerals in the 900' series of numbers. For example, the transducer array 900' includes transducers 902' aligned on a substrate 904'. However, the transducer array 900' has transducers 902' along a diagonal dimension to generate a two-dimensional image.

[0154] FIG. 45 illustrates a transducer array 1000′ according to another embodiment of the present disclosure. The transducer array 1000′ is similar to the transducer array 600′, and therefore, similar elements are referenced by similar numerals in the 1000′ series. For example, the transducer array 1000′ includes transducers 1002′ arranged on a substrate 1004′. However, the transducer array 1000′ does not cover the entire probe surface area as described in the previous embodiment. The transducers 1002′ are strategically positioned to allow projections of ultrasound signals across the probe surface area to cover the volume 10′ without having to have a transducer placed directly at each location in the volume 10′. This can be achieved as best shown in FIG. 45, where gaps between transducer rows 1003′ are configured to be covered by selected transducers 1002′ to transmit and receive ultrasound signals in multiple directions.

[0155] FIG. 46 illustrates a transducer array 1100′ according to another embodiment of the present disclosure. The transducer array 1100′ is similar to the transducer array 600′, and therefore, similar elements are referenced by similar numerals in the 1100′ series. For example, the transducer array 1100′ includes transducers 1102′ arranged on a substrate 1104′. However, the transducer array 1102′ is configured to move about the probe surface area, as indicated by the directional arrow 1104′. Thus, the transducer array size 1102′ can be significantly smaller than the previously described fixed transducer array. The resolution and range of the volume 10′ can be controlled by controlling the speed of the transducer array 1102′ across the probe surface area.

[0156] FIG. 47 illustrates a transducer array 1200′ according to another embodiment of the present disclosure. The transducer array 1200′ is similar to the transducer array 1200′, and therefore, similar elements are referenced by similar numerals in the 1200′ series. For example, the transducer array 1200′ includes transducers 1202′ arranged on a substrate 1204′. However, in this embodiment, the substrate 1204′ is circular and configured to be positioned around a region of a patient's body. The transducers 1202′ are configured to move about the probe surface area as indicated by directional arrows 1205′ along a circular path 1206′. Thus, a volume 10′ defined as a region within the probe surface area is covered by the mobile transducer array 1202′. Similar to the transducer array 1100′, the transducer array 1200′ requires only a small transducer array to generate a three-dimensional visualization of the volume 10′.

[0157] FIG. 48 illustrates a transducer array 1300′ according to another embodiment of the present disclosure. The transducer array 1300′ is similar to the transducer array 600′, and therefore, similar elements are referenced by similar numerals in the 1300′ series. For example, the transducer array 1300′ includes a transducer 1302′ aligned on a substrate 1304′. The transducer array 1300′ includes a slot 1310′ to allow a surgical procedure to be performed within an area around the periphery of the substrate 1304′, while the transducer array is positioned in a target body zone. The transducer 1302′ adjacent to the slot 1310′ is configured to cover a portion of the volume 10′ directly below the slot 1302′. For example, a transducer 1302' adjacent to a slot 1310' may be angled toward the volume 10' directly below the slot, such a transducer may have the ability to cover a larger portion of the volume 10' than others, etc.

[0158] FIG. 49 illustrates a transducer array 1400′ according to another embodiment of the present disclosure. The transducer array 1400′ is similar to the transducer array 1300′, and therefore, similar elements are referenced by similar numerals in the 1400′ series. For example, the transducer array 1400′ includes transducers 1402′ aligned on a substrate 1104′. The transducer array 1400′ includes a slot 1410′ extending across the array to enable a surgical procedure, while the transducer array is positioned in a target body zone. As discussed above with respect to FIG. 48, the transducer 1402′ adjacent to the slot 1410′ is configured to cover a portion of the volume 10′ directly below the slot 1402′.

[0159] FIG. 50 illustrates a transducer array 1500′ according to another embodiment of the present disclosure. The transducer array 1500′ is similar to the transducer array 1300′, and therefore, similar elements are referenced by similar numerals in the 1500′ series. For example, the transducer array 1500′ includes transducers 1502′ aligned on a substrate 1504′. The transducer array 1500′ includes a slot 1510′ extending across the array to enable a surgical procedure, while the transducer array is positioned in a target body zone. As discussed above with respect to FIG. 48 , the transducers 1502′ adjacent to the slot 1510′ are aligned and positioned to cover a portion of the volume 10′ directly below the slot 1502′.

[0160] FIG. 51 is a transducer array 1600′ according to another embodiment of the present disclosure. The transducer array 1600′ is similar to the transducer array 600′, and therefore, like elements are referenced by like numerals in the 1600′ series. For example, the transducer array 1600′ includes a transducer 1602′ aligned on a substrate 1604′. The transducer array 1600′ includes a first block 1610′ and a second block 1610″ that can be bent apart as shown in FIG. 51 . The separated first and second blocks allow for a surgical procedure while the transducer array is positioned at a target body zone.

[0161] 52 is a transducer array 1700' according to another embodiment of the present disclosure. The transducer array 1700' is similar to the transducer array 600', and therefore like elements are referenced with like numerals in the 1700' series of numbers. For example, the transducer array 1700' includes transducers 1702' arranged on a substrate 1704'. The transducer array 1700' is flexible and can be molded into any desired shape for placement in a particular body region.

[0162] While various transducer arrays have been illustrated and described above, other configurations are also envisioned. For example, the substrate may have a lower profile in any of the length, width, or height directions, depending on the application or intended use or the anatomical structure in which it will be used. Furthermore, any portion of the substrate and / or array may be flat, curved, tapered, etc., as desired, so that any substrate and / or array shape may be achieved.

[0163] Referring now to FIG. 53 , a flow chart is shown depicting a method 1900′ for performing cannulation using a visualization device 100′ according to another embodiment of the present disclosure. While visualization device 100′ is described here, any of the other described visualization devices or their various embodiments may be used to perform method 1900′. A probe surface 102′ is positioned over the desired cannulation zone. Transducers aligned with the probe surface area are activated by an algorithm to generate a series of two-dimensional images across volume 10′ in step 1920′. The two-dimensional images are combined into a three-dimensional visualization by an image processor and shown on displays 104′, 106′, and 108′. Additional details, such as projected cannulation location, projected cannulation depth, and projected cannulation path, may be displayed on visualization device 100′ in step 1930′. Cannulation parameters such as cannulation point location, venipuncture location, insertion depth, venous blood flow rate, blood pressure, and temperature may also be displayed by visualization device 100'. The operator can evaluate the three-dimensional visualization and cannulation parameters and begin cannulation in step 1940'. Cannulation may be performed manually or with the aid of a cannulation assembly. Visualization device 100' can track the location of the cannula during cannula placement in volume 10' to ensure accurate cannula placement.

[0164] FIG. 54 shows a flow chart depicting a method 2000′ for performing cannulation using a visualization device 200′ according to another embodiment of the present disclosure. Method 2000′ is similar to method 1900′ and includes the steps of positioning visualization device 200′ at a cannulation zone and generating a three-dimensional image of volume 10′. However, after the three-dimensional image is generated in step 2020′, the display and probe surface of visualization device 200′ are detached from mounting device 216′. Tracking device 214′ communicates real-time three-dimensional data of volume 10′ to the display of visualization device 200′. Cannulation can be performed manually or with the aid of a cannulation assembly. Visualization device 200′ can track the location of the cannula during placement of the cannula in volume 10 to ensure accurate cannula placement.

[0165] 56A-56C illustrate a GUI display 2200′ according to another embodiment of the present disclosure. The GUI display 2200′ includes a virtual drop shadow 215″ of the cannula 215′ to aid in three-dimensional perception of the spatial relationship between the skin insertion target, the vein insertion target, and the cannula 215′. As shown in FIGS. 56A-56C, as the cannula 215′ approaches the insertion target, the virtual drop shadow 215″ approaches the cannula tip 217′. During insertion, the cannula tip 217′ and the virtual drop shadow 215″ are in virtual contact, as best shown in FIG. 56C. Color variations may be applied to the vein 20′, nerve 22′, etc. to guide the cannula tip 215′ to the desired insertion point. For example, the insertion zone may be shaded green, while the nerve may be shaded red to allow the operator to reach the target zone without inadvertently bumping into objects to be avoided. The GUI display 2200' may include tactile or auditory feedback to the operator to assist in inserting the cannula 217' into the insertion zone. The GUI display 2200' may also include shaded zones in some embodiments to indicate zones or regions not being imaged by the probe surface.

[0166] 57A-57C show a GUI display 2300′ according to another embodiment of the present disclosure. GUI display 2300′ is similar to GUI display 2200′, but includes a second virtual drop shadow 219″. As the cannula tip approaches the insertion zone, virtual drop shadows 215″ and 219″ approach cannula tip 217′. Second virtual drop shadow 219″ provides additional visual guidance to the operator for successful cannulation.

[0167] 58A-58C show a GUI display 2400′ according to another embodiment of the present disclosure. GUI display 2400′ is similar to GUI display 2200′ and includes a virtual drop shadow 215″ of cannula 215′. However, as the cannula tip approaches the insertion zone, virtual drop shadow 215″ becomes increasingly more vivid and dark.

[0168] 59, there is shown a GUI display 2500′ according to another embodiment of the present disclosure. The GUI display 2500 detects an ambient light source 2502′ near the visualization device and orients a virtual drop shadow 215″ to match the ambient light source 2502′ for a seamless depth perception effect. The GUI display 2500′ helps prevent disorientation due to mismatched lighting angles in the room relative to the virtual lighting on the screen.

[0169] 60A-60C show a GUI display 2600′ according to another embodiment of the present disclosure. The GUI display 2600′ includes a cannula path indicator 2602′. The cannula path indicator 2602′ depicts the projected path of the cannula 215′ through the skin and volume 10′ depending on the orientation of the cannula. For example, when the cannula 215′ is positioned as shown in FIG. 60A, a skin insertion point 2604′ and a cannula path indicator 2602′ are shown on the GUI display 2600′. When the cannula is properly aligned with the insertion vein 20′, a vein insertion point 2606′ is visible on the GUI display 2600′ as shown in FIGS. 60B and 60C. The GUI display 2600' indicates the suitability of the venous insertion point 2606' based on the projected track of the cannula within the vein 20' as depicted by track indicator 2608' (unsuitable) or 2610' (suitable).

[0170] 61A-61C show a GUI display 2700′ according to another embodiment of the present disclosure. GUI display 2700′ is similar to GUI display 2600′, and therefore, like elements are referenced with like numerals in the 2700′ series of numbers. For example, GUI display 2700′ includes a cannula path indicator 2702′, a skin insertion point 2704′, and a venous insertion point 2706′. However, GUI display 2700′ includes a projected distal tip 2712′ of the cannula based on the location of the cannula and the alignment of the cannula with volume 10′.

[0171] 62, a GUI display 2800' according to another embodiment of the present disclosure is shown. The GUI display 2800' displays an ideal cannulation point 2802' to aid in successful cannulation. Inappropriate insertion points, such as vein regions 2804' suffering from sclerosis and vein areas 2806 just below or above the artery 32', may be displayed on the GUI display 2800'.

[0172] 63A-63D show a GUI display 2900′ according to another embodiment of the present disclosure. The GUI display 2900′ has the ability to magnify the displayed image of the volume 10′. Magnification can be performed manually by an operator to enlarge the image or to focus the image at a desired location, such as the insertion point, or automatically by the visualization device based on the location of the cannula. Manual magnification can be performed via a touch screen on the GUI display 2900′. The GUI display 2900′ includes a grid 2902′ for representing the magnification level on the display screen.

[0173] 64A and 64B illustrate a GUI display 3000′ according to another embodiment of the present disclosure. GUI display 3000′ expresses depth perception by varying the brightness / darkness of objects based on depth. For example, second vein 23′ appears darker than nerve 22′, which is darker than vein 20′, to indicate the relative depth of each of these elements in FIG. 64A. Similarly, various color schemes and patterns may be used to indicate the relative depth of each element, as shown in FIG. 64B. Note that any of the GUI display concepts disclosed herein may be used individually or collectively in a visualization device. For example, GUI display 3000′ may be used in conjunction with GUI display 2200′, GUI display 2900′ may be used in conjunction with GUI display 2800, etc.

[0174] 101A-102B illustrate a visualization device 22000 according to another embodiment of the present disclosure. The visualization device 22000 has a relatively large surface area with a transducer 22008 on a first side and a display 22014 on an opposite side, as best shown in FIGS. 102A and 102B. The large surface area of ​​the visualization device 22000 provides sufficient coverage for visualizing large anatomical features with a single positioning of the device. Furthermore, the large display ensures that the visualized anatomical features are displayed in sufficient detail to enable appropriate imaging and / or procedures to be performed at the surgical site.

[0175] A strap 22002 with a pad 22004 is secured to the surgical site as shown in FIG. 101A . The pad 22004 includes gel 22206 and fixation features 22008 to allow for easy attachment and removal of the visualization device 22000. As best shown in FIG. 102A , when the visualization device is placed on the surgical site, the transducer array 22008 spans over the ribs 22010. Each transducer of the transducer array 22008 emits and receives signals 22012 that propagate between the ribs 22010 and diverge beyond the rib opening to cover the area below the ribs. Thus, all anatomical features below the ribs can be captured by placing the visualization device 22000 in a single location. A display 22014 shown in FIG. 102B depicts the ribs 22010 and soft tissue, such as the heart 22016, found below the ribs.

[0176] FIG. 103A shows a visualization device 22000 that performs 3D, real-time imaging of a heart 22016 during a procedure. The strap 22002 and pad 22006 allow the visualization device to be securely positioned at the surgical site, allowing the surgeon to manipulate and view real-time imaging of the procedure. While the visualization device 22000 images anatomical features located behind the ribs in this embodiment, the visualization device 22000 can be used in other applications to visualize anatomical features located behind or below other anatomical features that typically obscure and prevent visualization of internal anatomical features. For example, hard tissues such as bone prevent conventional ultrasound imaging from generating adequate images of organs and soft tissues located below the hard tissue. The visualization device 22000 of the present disclosure can be easily used to generate 3D, real-time images of these organs and soft tissues by capturing image data through gaps or across the periphery of the hard tissue.

[0177] 103B and 103C show a visualization device 22000 secured by a stand 22052, 22054 according to another embodiment of the present disclosure. The stand may be a tripod 22052 as shown in FIG. 103B or a frame 22054 having four legs as shown in FIG. 103C. The stand is configured to simultaneously ensure secure mounting of the visualization device 22000 at the surgical site and provide access for performing the medical procedure.

[0178] A transducer 23000 according to another embodiment of the present disclosure is shown in FIGS. 104A-104D. The transducer 23000 includes a central groove for receiving the raised portion of the pad 23002, as best shown in FIG. 104A. Transducer arrays are located on both surfaces 23004 of the central groove of the transducer 23000, as shown in FIG. 104B. Transducer arrays located on these oblique planes relative to the skin surface allow wave transmission 23010 to be directed toward and identify the anatomical feature. As shown in FIG. 104C, in this example, the anatomical feature is a vein 23012. A transducer coupled to the vein 23012 pad may be positioned to allow the raised portion of the pad 23002 to be directly over the vein 23012, as shown in FIG. 104C. The operator or inserter assembly can advance the needle 23012 precisely along the direction 23006 into the raised portion of the pad 23002 and into the vein. This ensures that the needle does not unintentionally penetrate or damage other anatomical features, such as nerves 23012.

[0179] 105 , there is shown a visualization device 25000 in accordance with another embodiment of the present disclosure. As shown here, the visualization device 25000, in this example, is coupled to a support 24000. The visualization device 25000 includes a mobile transducer array 25002 that moves across the distal surface of the visualization device to scan the distal surface. A button 25004 or other feature is provided on the visualization device 25000 to allow for easy attachment and detachment from the support 24000.

[0180] 107A-E illustrate a visualization system 26000 according to another embodiment of the present disclosure. The visualization system 26000 includes multiple transducers 26001, 26002, 26003, and 26004 positioned at different locations as shown in FIG. 107A. The multiple individual transducers are located at different locations relative to the target surgical site. As shown in FIG. 107A, transducer 26001 is located in the parasternal region, transducer 26002 is located in the apical region, transducer 26003 is located in the subcostal region, and transducer 26004 is located in the suprasternal region. Each transducer generates an image dataset of the heart based on its location. The image datasets are then combined and processed to generate a complete image dataset of all relevant anatomical features of the heart and displayed on a remote display 26005. An operator can manipulate the image datasets to view specific features of the heart, as shown in FIGS. 107B-107D.

[0181] The visualization system 26000 allows the surgeon to view and analyze 3D real-time images of the relevant anatomical sites on a remote screen 26005. As best shown in FIG. 107E, this allows the surgeon to simultaneously perform a procedure while viewing real-time 3D images of the anatomical structures generated by multiple transducers. While cardiac treatment is shown in this example, the visualization system 26000 may be advantageously used for any medical procedure or for imaging alone.

[0182] 108A-C, a kit 28000 according to another embodiment of the present disclosure is shown. The kit 28000 may include multiple visualization devices 28100 (FIG. 108A) that can be paired with multiple pads 28200 (FIG. 108B). The visualization devices 28100 may have different shapes, sizes, arrangement configurations, displays, etc. In this example, three visualization devices 28100 are provided in the kit 28000: small 28101, medium 28102, and large 28103. Similarly, the pads 28200 may have various configurations to pair with all or some of the visualization devices in the kit 28000. As shown in FIG. 108B, the pads 28201, 28202, 28203, 28204, 28205, 28206, 28207, 28209, and 28210 have various shapes and configurations. The operator can select a visualization device 28100 to pair with a corresponding pad 28200 from kit 28000 for a particular visualization and / or procedure, as shown in FIGURE 108C. Kit 28000 allows the operator to customize visualization devices and pads based on patient-specific requirements.

[0183] 108D shows a first example of a visualization device paired with a pad from kit 28000 to perform a specific image visualization. Visualization device 28103 is paired with pad 28210, which has a concave surface to trace the contours of the patient's abdomen in gynecological visualization. The visualized image, in this example, a baby, can be viewed and manipulated by the operator on visualization device 28103.

[0184] 108E shows another example of kit 28000. In this example, visualization device 28102 is paired with pad 28208 and attached to the side of the patient's knee to visualize the knee joint. In this example, the paired visualization device and pad may be secured to the patient's knee to enable imaging of the patient's knee during flexion and extension. The surgeon can visualize the knee joint in real time throughout the knee's full range of motion to assess the condition of the joint.

[0185] FIG. 108F shows a third example of kit 28000. In this example, visualization device 28101 is paired with pad 28206 for examining a reclining patient. The compact size of visualization device 28101 and the molded shape of pad 28206 allow the surgeon to conveniently position the assembly and perform visualization without the need for invasive scanning. Another example of kit 28000 is shown in FIG. 108G. Visualization device 28101 can be paired with any of the pads in kit 28000 to view and any grafts implanted in the fistula tract. The compact size of 28101 and secure placement of the assembly allow the surgeon to simultaneously view the anatomical site in 3D, real-time, and perform the procedure.

[0186] FIG. 108H shows a table with technical specifications of various visualization devices according to one embodiment of the present disclosure. Exemplary technical specifications for small, medium, and large visualization devices are listed in the table. The technical specifications include certain attributes of these devices, including size, battery requirements, and performance metrics. The values ​​shown in FIG. 108H are exemplary and are not limiting of embodiments of the present disclosure.

[0187] 109, a customized kit 29000 is shown in accordance with another embodiment of the present disclosure. A customized pad 29200 is created and paired with a visualization device 28101. The pad 29200 may be formed using a 3D printed mold 29002. The mold 29002 may be customized to fit the patient's specific needs and the unique requirements of the procedure. In this example, the surgeon uses tool 29203 to perform brachytherapy, as shown in FIG. 109.

[0188] 110A-D show a visualization system 30000 according to another embodiment of the present disclosure. The visualization system 30000 includes a visualization device 30002 and a pad 30004. As the needle tip 30006 approaches the insertion point 30008, a sensor placed on the visualization device tracks and displays the approaching needle tip on the visualization device 30002. As shown in FIG. 110B, both the needle tip and the insertion point are displayed on the visualization device 30002. This allows the operator to position and align the needle so that it accurately enters the insertion point. A PMUT or CMUT transducer is provided on the bottom of the visualization device 30002 to track the needle tip when it is below the visualization device—i.e., within the transducer range—while other sensors, such as a camera, infrared, or near-infrared sensor, can be provided to track the location of the needle adjacent to, but outside of, the projection footprint of the visualization device. In other embodiments, PMUT or CMUT transducers may be provided on an angled surface to transmit signals outside the visualization device's footprint to track and identify the approaching needle. Various rendering and image corrections may be performed by the visualization device 30002 to facilitate accurate insertion. For example, a projected needle trajectory 30012 based on the needle's current location may be displayed, as shown in FIG. 110C. This will allow the operator to adjust and align the needle for precise entry at the insertion point 30008. As the needle tip enters the vein 30014 via the insertion point, the vein and needle tip are displayed on the visualization device 30002, as shown in FIG. 110D. The visualization system provides real-time 3D images with enhanced rendering to ensure proper pre-alignment, insertion, and final placement of the needle.

[0189] FIG. 116 illustrates a visualization system 36000 according to another embodiment of the present disclosure. The visualization system 36000 includes a visualization device 36002 that can be placed in a pad 36004 via a slot 36008 provided in the pad. The visualization assembly 36000 can be placed on a stool 36006 to enable imaging of a patient seated on the stool. FIG. 17 illustrates a visualization system 37000 according to another embodiment of the present disclosure. The visualization system 37000 is similar to visualization system 36000, except that in this embodiment, the visualization device 37002 is inserted directly into the stool 37006 via a slot 37008 in the stool. In other embodiments, the visualization assembly can be configured to be placed in other medical equipment for convenient imaging and / or treatment.

[0190] 119A and 119B illustrate a visualization system 39000 according to another embodiment of the present disclosure. The visualization assembly 39000 includes a visualization device 39002 having a plurality of vents 39006, as shown in FIG. 119A. A fan or other pressure-inducing element aligned within or connected to the visualization device 39002 draws air through the vents, creating suction. The air movement further promotes cooling of the device's electronic components and ensures proper functioning of the visualization device. The visualization device 39002 is coupled to a pad 39004.

[0191] 122A-D illustrate a visualization device 42000 according to another embodiment of the present disclosure. The visualization device 42000 includes a dual display window showing a plan view 42002 and a cross-sectional view 42004, as shown in FIG. 122A. The dual display can be deactivated to show a single display if desired. The operator can choose to view only the plan view, as shown in FIG. 122D, or only the cross-sectional view, as shown in FIG. 122C. The circular shape of the visualization device 122D allows the operator to conveniently hold and slide the device across the patient's skin to find a suitable insertion location. Once a location is identified, the operator can rotate the 3D image to further evaluate the anatomical conditions at the potential insertion side, as shown in FIG. 122C.

[0192] 123 shows a visualization device 43000 according to another embodiment of the present disclosure. The visualization device 43000 includes a camera or other sensor 43002 positioned on the lateral surface of the probe to identify and track the needle 43004. A display 43008 combines video of anatomical features scanned by the PMUT or CMUT transducer with real-time images of the advancing needle captured by the camera 43002. The visualization device 43000 allows needle tracking to determine the ideal needle angle and location before the needle enters the pad 43006 and then the insertion zone.

[0193] 127A-127D, a visualization assembly 47000 according to another embodiment of the present disclosure is shown. The visualization assembly 47000 includes a visualization device 47002 that can be coupled to a pad 47004. The visualization device 47002 and pad 47004 are designed to be placed on a patient's face, head, limbs, or body, as best shown in FIGS. 127B-D. The skin-contacting surface of the pad 47004 can include various features for convenient coupling with the patient's face, head, limbs, or body. As shown in FIG. 127A, depressions 47004 are provided in the pad 47004 for the patient's eyes to rest on. The visualization device 47002 includes a display 47008 for showing a real-time 3D image of the brain 47010. The distal face of the visualization device 47002 includes an array of transducers distributed across the face, but only those transducers not obstructed by bone—i.e., the skull in this example—will be activated to transmit and receive signals. As best shown in FIGS. 127C and 127D , the active transducer 47018 propagates diverging 47014 and 47012 signals that extend well beyond the patient's eyes and cover brain tissue. The active transducers transmit and receive signals within the orbital space, as shown in FIG. 127D . The wide-ranging, diverging signals 47014 generate a real-time 3D image of the brain. Transducers 47016 obstructed by bone are not activated during imaging. Activation of specific transducers can be performed automatically by the visualization device or manually controlled by the operator. Straps or other fixation devices can be used to securely attach the visualization assembly 47000 to the patient's face, head, limbs, or body.

[0194] As shown here, 3D real-time imaging can be performed using a transducer array having one or more independent arrays—i.e., a continuous transducer array is not required. The processor of the visualization device 47002 determines the relative location and orientation of multiple transducers placed on a patient's face, head, limbs, or body to enable them to function in concert. Image data can be acquired by combining any of these transducers. For example, imaging data can be acquired by transmitting and receiving from a single transducer array, or by transmitting from one transducer array and receiving from one or more of the other arrays. The imaging and generation of each transducer array is similar to that of a single transducer array. Once this data is acquired, the processor can triangulate the location of the arrays and combine the data to generate a volumetric image dataset. Thus, the strategic activation of specific transducers and the ability to process the resulting image dataset enable the visualization device to produce high-quality real-time image data of anatomical features located behind hard tissues, such as bone, fluid, and other features that are obstacles to imaging. Furthermore, the visualization device of the present disclosure can be located in a single location to generate these images without the need to move the device around the surgical site.

[0195] As the number of arrays increases, a more detailed picture of the tissue of interest can be constructed. Imaging of each array is similar to that of a single array, but triangulation between arrays can be used to combine data sets from multiple arrays.

[0196] The visualization device 47002 may include standard ultrasound signal processing capable of determining tissue anatomical features in B-mode and tissue harmonic imaging. The visualization device 47002 may also utilize the Doppler effect to detect blood flow at the surgical site. An autocorrelation estimator within the visualization device may provide a display that combines spatial and flow information in flow mode by using color to display this information to the surgeon. Fourier analysis may be used to show the spectral distribution of Doppler shift in pulsed Doppler and CW Doppler modes. The visualization device 47002 may also provide elastography data that identifies tissue stiffness.

[0197] The visualization device 47002 may include Quantitative Ultrasound ("QUS") to quantify returning echoes. The unique value of QUS processing allows the visualization device to identify and distinguish between various tissue types. For example, nerve and muscle tissue may look very similar on a standard ultrasound display, yet they can be distinguished.

[0198] A QUS algorithm can be implemented by the visualization device to estimate quantities such as the concentration of acoustic scatterers in tissue and the average separation of these scatterers. The QUS algorithm can operate in the time domain or the frequency domain. A QUS algorithm operating in the time domain can be based on statistical measures applied to radio frequency signals coming from the visualization device's beamformer. A QUS algorithm operating in the frequency domain can be based on a Fourier transform of a portion of the radio frequency signal received by the device. The estimated quantities by the QUS algorithm will reveal data encoded in the signal received by the visualization device but not visible on a standard grayscale or color display. Different tissues have different values ​​of QUS parameters that can be processed by a machine learning system to create and indicate the type of tissue present at each location within the imaged volume.

[0199] 128A and 128B show a visualization assembly 48000 according to another embodiment of the present disclosure. The visualization assembly 48000 includes a visualization device 48002 configured to be coupled to a pad 48004. In one embodiment, the pad 48004 may include a moldable material that assumes the shape of the visualization device 48002 when the visualization device 48002 is pressed against the pad, as shown in FIG. 128B. The visualization assembly 48000 is configured to be placed over a patient's eye to create a monocular, as shown in FIG. 128A. The display 48004 shows the eye scan in real time. In other embodiments, the visualization assembly may be customized to scan various other parts of the body for pelvic imaging, abdominal imaging, transabdominal imaging, transrectal imaging, obstetric imaging, carotid artery imaging, abdominal aorta imaging, etc.

[0200] Moving needle 1A for ease of reference, after the inserter assembly 300 is coupled to the housing 100, the housing 100 can manipulate the inserter assembly to adjust the orientation of the inserter assembly relative to the patient and the selected puncture site. For example, the inserter assembly may undergo small movements taking into account data provided by the navigation system to ensure that the needle of the inserter assembly enters the patient at the puncture site and enters the puncture site at the proper angle, depth, and trajectory.

[0201] The housing's ability to move the inserter assembly can be semi-autonomous or fully autonomous - for example, the housing may have the ability to operate autonomously to optimally position the needle, ready for insertion at the puncture site and into its intended location within the circulatory system (or other location within a bone or anatomy). The actual step of inserting the needle into the patient may then be performed autonomously (e.g., once the optimal location is found, the needle is automatically inserted into the patient) or semi-autonomously (e.g., by having an operator interact with the device via a button or the like to initiate insertion).

[0202] With these functions in mind, the housing may include various sensors, mechanical elements, etc., all of which increase the ultimate placement of the needle at the puncture site.

[0203] For example, one embodiment of the present disclosure includes an inserter assembly 300 having a needle 301 within a housing 100, as shown in FIGS. 16A-16B. The housing 100 includes a needle actuation system 150, which may include the elements described above, e.g., sensors and mechanical elements, e.g., motors or servo mechanisms for precision control, placement, insertion, and withdrawal of the needle. For example, a servo motor may enable fine linear translation in all three directions, i.e., front-to-back, left-to-right, and up-and-down movement, as shown in FIG. 16B. The needle actuation system may also have a rotational or pivot joint to allow the inserter assembly to be rotated in one or more planes. This will allow the needle to be aligned along a predetermined insertion trajectory.

[0204] As shown in the embodiment of FIGS. 16A-16B, needle actuation system 150 is located within housing 100 along with sensor array 160, which may be part of a navigation system and / or may be sensors that provide information to needle actuation system 150 to control inserter assembly 300. System 150 includes a primary control arm 151 that connects inserter assembly 300 to housing 100 and needle actuation system 150. Primary control arm 151 is controlled by one or more servos (not shown) also located within housing 100. The direction and extent of movement of inserter assembly 300 is defined by the size of the inserter assembly and the size of housing 100. FIG. 16B shows a top view of housing 100 to illustrate the extent of movement of inserter assembly 300 in the X and Y directions within housing 100. Additionally, the control arm 151 may have the ability to rotate the inserter assembly in at least the R direction to allow movement of the inserter assembly including the Z direction (i.e., into and away from the page and perpendicular to both the X and Y directions). Movement in the Z direction may provide for adjustment of the angle of entry of the needle 301 at the puncture site and ultimately into the patient's vasculature or other anatomical structure.

[0205] 17A-17B show another embodiment of a needle actuation system 150 similar to that of FIGS. 16A-16B, except that in this embodiment, the inserter assembly 300 is flexible. As shown, the flexibility of the assembly 300 may allow for increased movement of the assembly 300 within the housing. Alternatively, a flexible assembly 300 may allow for the use of a smaller housing 100 while still maintaining a similar range of movement as is possible in the embodiment of FIGS. 16A-16B. The flexible portion of the inserter assembly 300 may simply be a flexible housing over the various elements of the assembly 300 and / or may include flexible elements of the assembly 300, such as tubes, vials, needles, etc.

[0206] In certain embodiments, the device may achieve a needle 301 that can be positioned in an infinite number of locations through the use of a "universal" joint. Such a joint requires multiple servos capable of moving the needle in any desired direction, including the X, Y, and Z directions, the direction of rotation, the T direction (i.e., direction of needle tilt), and the D direction (i.e., direction of needle drive) ("XYZRTD" movement). In such an example, this universal movement may require a relatively large housing 100 to provide clearance for the inserter assembly 300 to move within the housing.

[0207] As described more fully above, the navigation system may provide information to the needle actuation system 150 to guide the needle 301 to the correct location on the patient. As such, the needle actuation system accumulates this data and, based on this data, actuates a servo to move the needle to the desired location as directed by the navigation system. In addition, the servo may receive feedback via other sensors that measure such information, for example, the location of the needle and inserter assembly 300, the force with which the needle is being applied to the patient, the force of the patient's anatomy pushing back against the needle, etc. As such, additional sensors, such as force sensors or tactile sensors, may be coupled to the needle actuation system to control and monitor proper needle insertion. Precision servos and motors ensure that the needle insertion operation is performed accurately based on, among other things, the translational speed, penetration depth, penetration angle, and insertion force to pierce the skin. For example, the needle translational speed can be adjusted to reduce patient discomfort or increased to achieve skin puncture. The needle actuation system can provide variable needle translation speed, where the needle quickly penetrates the skin (to reduce discomfort) and then decelerates while penetrating the vessel for maximum accuracy. Similarly, the speed of needle retraction can be variably controlled for optimized performance.

[0208] In one embodiment, the needle actuation system may be capable of being controlled by an operator as a semi-autonomous element. In such a configuration, a haptic force feedback system may be used. Specifically, a virtual tactile geometry of the needle insertion location, trajectory, and depth may be created to generate a virtual boundary that allows the operator to perform the insertion with the aid of a navigation system and GUI. The needle actuation system may include a micromanipulator coupled with a force sensor for precision control of needle movement in a semi-autonomous system.

[0209] Inserter Assembly The device can be configured for use with different inserter assemblies, including a variety of needles and needle accessories. In one embodiment, once a needle is attached, the navigation sensor detects and calibrates the device to perform insertion with the attached needle size. This will allow the device to be available for universal use with a large number of different needles in a variety of procedures, such as those expected in typical hospital use. As mentioned above, the desired needle can be included on the base prior to setup, or in certain embodiments, the needle can be attached to the device after the base and housing are already placed on the patient.

[0210] Alternatively, a kit having at least one needle and at least one inserter assembly may be provided. The kit may include needles of various sizes along with various accessories for use with the needles and located within the inserter assembly. For example, the inserter assembly may be a universal element that can be used with any size needle and any desired needle accessory.

[0211] While rigid needles, i.e., without cannulation, can be used with the device, cannulated needles can also be used to allow flashback, allowing the operator to confirm that needle insertion into the vessel has been achieved. However, the device may not require this visual confirmation, as feedback received from the navigation and needle insertion system ensures successful needle insertion. As a result, the device can function with rigid needles, which can reduce patient discomfort during needle insertion. Other needles, such as flexible needles, adjustable needles (e.g., needles with telescoping capabilities that allow for needle size minimization), and the like, can also be used with the device.

[0212] A kit including a patch 750 with an inserter assembly 760 is shown in FIGS. 20A-B in accordance with another embodiment of the present disclosure. The inserter assembly 760 includes a skirt 762 that rests on the needle. The skirt may act as an additional sterility shield around the inserted needle (and ultimately, optionally, the cannula) at the puncture site. The skirt may include an adhesive surface that secures itself to the patient's skin at the puncture site, or the skirt may be coupled to an integrated pre-applied patch 750 that rests or can rest on the patient's skin. The patch 750 includes a top layer 751 for connecting with the device and the inserter assembly 760 and a bottom surface 754 for adhering to the patient's skin. The bottom surface 754 may be an automatic sealing member that seals after needle penetration to prevent infection at the puncture site and to keep any blood from the puncture site away from the operator. The bottom surface 754 may include adhesive features that can be activated or deactivated by the operator or any other response. Additional layers, such as a flexible layer 752 having venous preparation components to dilate the vein for insertion, are located between the bottom surface 754 and the top layer 751. The venous preparation components can include heating, electricity, and chemicals. An analgesic layer 753 is also provided, as shown in FIG. 20A, to reduce pain and discomfort during needle insertion. The bottom surface 754 can be secured to the skin via adhesive, light- or vibration-activated adhesive, friction, an interlocking mechanism, or the like. This can be particularly useful for long-term IV use, which typically requires additional taping to secure the cannula to the patient. Instead of an additional taping step, the operator can quickly slide the skirt into place, which can help maintain the needle / cannula in place relative to the patient.

[0213] With particular reference to Figures 28 through 31, disclosed therein are various exemplary embodiments of how movement, including micro-movement, of the inserter assembly and / or housing may be accomplished in any of the devices contemplated herein.

[0214] 28 through 31C illustrate various embodiments of the present disclosure. As shown, device 1200 includes a strut mounting structure or strut mount 1201 to which a plurality of articulating struts 1202 are attached at first ends 1207 with articulating joints 1203, such as hinged, universal, or ball joints. Struts 1202 may achieve linear movement driven by integrated or adjacent linear motors 1204, e.g., piezoelectric linear motors such as squiggle motors, pull wires with remote motorized drives, or pneumatic drives. Alternatively, struts may include hinged sections. The advantages of these articulation and drive types are extreme compactness and precision. Strut mounting structure 1201 may be a generally rectangular, as shown in FIG. 28, or a generally circular, as shown in FIG. 30, or a generally triangular, fully or open-sided aperture, as shown in FIGS. 31B and 31C. The strut mounting structure 1201 may consist of a vertically straight or angled post 1215, as shown in FIG. 31C , attached below or laterally to the strut mount; for example, the strut mount may be structurally joined to an area of ​​an external casing, structure, or frame within or integral to the device 1200. FIGS. 31A and 31B show an embodiment in which the strut mounting structure is integrated with a rigid aperture 1205 of the device 1200. The device may include a floating platform 1210 to which the second ends 1208 of each of a plurality of struts may be attached at articulating joints 1209, such as hinged, universal, or ball joints. During operation, the platform 1210 lies substantially adjacent to and / or parallel to the patient's body, e.g., near the target intravenous needle injection site. The plurality of struts may mechanically articulate to move the platform with up to six degrees of movement.28-31C, the device may have six struts 1202, often referred to as a hexapod, which together have the ability to move the platform in all directions: X (lateral), Y (longitudinal), Z (into or away from the body), yaw (rotation), roll (tilt to the side), and pitch (tilt forward and backward). In alternative embodiments, the device may include three struts, referred to herein as a tripod, or four struts, referred to herein as a tetrapod.

[0215] Continuing with FIGS. 28 through 31C, the floating platform 1210 can include an anatomical imaging module capable of collecting 2D, 3D, or 4D data from a target site beneath the patient's skin. The platform can be moved with varying degrees of motion to align with the desired site. The platform can also be moved in a manner that allows the bottom of the platform to be pressed against the patient or massage an area of ​​the patient, e.g., to evaluate the characteristics of a particular vessel under compression. This can provide important additional information when assessing veins versus (typically less compressible) arteries. The platform can also perform a vibrating or tapping motion to stimulate the vessel, i.e., to make the vessel more optimal, more distended, or raised closer to the skin's surface for further cannulation conditions, i.e., to increase the lumen size and make it easier to target. As shown in FIGS. 29 and 30, the platform and / or surrounding area can include a heating element 1211 to warm and encourage dilation of the underlying vessel. Platform vibration, e.g., caused by high frequency micro-motion generated by one or more of the struts 1201, can be activated upon needle insertion to act as a pain gate stimulus to disrupt the local, adjacent, or surrounding peripheral nervous system via stimulation. As shown in FIG. 29, the platform can include a cooling element 1212 targeted near or adjacent to the insertion site and can be activated to cause a temporary numbing effect as a means to numb the sensory effects caused during needle incision, e.g., pain management.

[0216] Additionally, the platform can include a fixed or articulating conduit 1213, sometimes referred to as a mount, which can hold a needle or cannula, or an injection module 1214 housing the needle and / or cannula. The conduit can provide additional degrees of motion to the platform 1210, referred to herein as local motion, as a supplement to the degree of motion achieved by the plurality of struts 1202, which can be referred to as global motion. At higher degrees, the conduit can provide six degrees of local motion, such as X, Y, Z, R yaw, roll, and pitch. More preferably, the conduit will provide local rotation (local yaw) and local tilt (local pitch). Additional motions, referred to herein as super-local movements, provided by the conduit 1213 attached to the platform or within the injection module or cannula itself can include drive (to push or pull the needle or cannula along its axis) and twist (to orbit the needle or cannula about its longitudinal axis). In certain embodiments, the conduit 1213 and the injection module 1214 may be provided as a single assembly.

[0217] After the device 1200 is guided by its imager module to align the target vessel, if the target then moves, for example, due to shaking or trembling of the patient or operator, or if the device otherwise misses the target, the device can automatically correct the needle location and trajectory as maintained by the conduit to align the target - hence the floating platform.

[0218] Additionally, with its integrated strut mount structure, device 1200 is desirably configured to be compact in external dimensions while also providing a floating platform with a maximum degree of movement to provide the ability to scan relatively large areas of the anatomy so that optimal needle or cannulation conditions can be found. The overall height of device 1200 may be between 8 and 22 mm, including 8 mm and 22 mm. The circular embodiment of FIG. 29 may have a diameter between 25 mm and 75 mm, including 25 mm and 75 mm. Platform 1210 may be mechanically lockable so that the user can move the device around the arm as an initial positioning step, and then, with the integrated floating imaging platform, the device can perform finer or more precise movements and image and needle alignment.

[0219] The device 1200 may also include a control unit and a display. The display may be substantially the same size as the device top surface and may include touch controls. Alternatively, or in addition, the device may include a controller stick, or joystick. These controls may be used by the operator to manipulate any or all of the mechanized degrees of motion to align and place the needle or cannula with robotic assistance.

[0220] 86A-89C show an inserter assembly 18000 according to another embodiment of the present disclosure. The inserter assembly 18000 includes a three degree of freedom parallel mechanism that positions the needle drive mechanism 18001. The needle drive mechanism 18001 carries and moves the needle 18020 to perform the insertion. A single degree of freedom mechanism delivers the needle driver 18008 into the patient's anatomy and retracts the needle when the procedure is complete. As best shown in FIG. 86A, the inserter assembly 18000 can be attached to the device 5000 and pad 16000.

[0221] The needle 18020 is attached to a lead screw 18017 and threaded carriage 18016 as shown in FIG. 89C. The carriage 18016 is restrained by the housing 18015 in such a way that the housing supports off-axis loads and does not require additional support. This design allows the inserter assembly to have a compact size.

[0222] The needle 18020 may be contained in a disposable sterile container through which operation is controlled while maintaining a sterile barrier between the mechanism and the needle.

[0223] Two parallel linear mechanisms, such as the lead screw 18006 shown here, jointly control the angle and location along the x-axis of the main carriage 18012 to control needle insertion location. The linear mechanisms are coupled to the main carriage 18012 in such a way that, when moved synchronously, the main carriage 18012 maintains a constant orientation and moves along the x-axis. Furthermore, the coupling between the linear mechanisms and the main carriage 18012 allows the main carriage to rotate with zero translation when moved asynchronously. This motion can be controlled by the independent movement of two threaded pins 18014 driven by the lead screw 18006. The main carriage 18012 is free to rotate relative to one pin and free to rotate and translate relative to the other. In an alternative embodiment, the functions of the pins and main carriage can be coupled by a compatible structure including a flexure hinge and a threaded feature that interfaces with the lead screw.

[0224] Two support shafts 18011 are provided to block moments and loads on the needle that are not aligned with the x-axis, which increases the efficiency and useful life of the linear mechanism 18006.

[0225] Linear guide 18007 is the interface between the needle driver and main carriage 18012, allowing free movement along the y-axis while constraining movement in other directions. Rail 18004 controls the Y location of needle driver 18008 while allowing unconstrained movement of the needle driver along the x-direction. Connection pin 18019 interfaces rail 18007 with needle driver 18013.

[0226] A linear mechanism 18001, such as a lead screw shown here, controls the movement of a rail 18004 along the Y direction. Two linear guides 18003 resist moments on the rail, thereby increasing the efficiency and useful life of the linear mechanism 18001.

[0227] Four electromagnetic rotary motors 18002, 18005, 18010, 18018 are used to power the linear mechanism due to their high power density. In other embodiments, these motors may be piezoelectric motors, which can reduce the noise emitted by the device. Hydraulic or pneumatic motors may also be used. In other embodiments, linear motors are used to power the linear mechanism. In other embodiments, the support shaft 18011 may not be provided; instead, the linear mechanism 18009 can directly resist off-axis loads. This is advantageous because it makes the mechanism more compact.

[0228] Through the use of lead screws on all four axes, the linear resolution of the inserter assembly 18000 is significantly increased so that the needle can move a fraction of the diameter of the vein for 360-degree rotation of the motor. Additionally, the effects of slack in the motor are dramatically reduced. Unintended overloads on the device due to operator error or accident are not transmitted to the motor due to the non-backdrivability of the lead screws and the gear connection between the motor and lead screws. The positioning and insertion speeds of the inserter assembly 18000 are on the same order of magnitude as a human operator. Furthermore, the inserter assembly 18000 is configured to apply forces similar to a human operator to insert and manipulate the needle within the human anatomy.

[0229] 93A-F show an inserter assembly 19000 according to another embodiment of the present disclosure. The inserter assembly 19000 includes two members 19005 that can be moved in opposite directions to produce rotation of a linear mechanism 19004 and control the angle ρ of the needle drive mechanism, as best shown in FIG. 90. One member 19005 is coupled to the linear mechanism via a pin node 90012 that can rotate relative to the member and translate relative to the linear mechanism.

[0230] Member 19005 may be controlled by a gearbox that links the two members in such a way that their movements in the X direction are opposite to each other and are driven by a single gear, the gearbox having the ability to rotate the member about axis P to affect the rotation of the linear mechanism about axis P and the movement of the needle axis essentially in the Y direction.

[0231] The gearbox is driven by two worm gears 19011, which allow for independent control of the gearbox rotation and the linkage movement. The linkage movement is controlled by a rack and pinion 19015, with power transmitted through a central shaft driven by a large sun gear 19013. A linear mechanism 19004 controls the location of the main carriage 19007 primarily along the X direction. The main carriage 19007 is moved by the linear mechanism, which carries the needle driver mount 19009, as best shown in Figures 93D-93F.

[0232] The linear mechanism may include a lead screw 19017 that drives the carriage. Before the procedure begins, a needle driver mount 19009 connected to the needle driver is installed. The needle driver mount 19009 is attached to the carriage in such a way that it has a single rotational degree of freedom that is precisely controlled. The rotational degree of freedom results in rotation of the needle driver, controlling the angle Φ as shown in FIG. 91.

[0233] Five electromagnetic rotary motors 19002, 19003, 19010, 19019, 19020 may be used to power the inserter assembly 19000 due to their high power density. Power may be sent via a shaft to a linear mechanism that drives the needle. Torque may be sent to a lead screw via a mating pin 19019 and a housing that is temporarily secured to the inserter assembly 19000 by the user via a push and twist action. The cartridge may be a disposable, sterile, unpowered, self-contained assembly.

[0234] The mechanical design of the arm 19005 linkage and differential gearbox within the inserter assembly 19000 is particularly advantageous in that it allows highly accurate, independent control of both the ф and ρ orientations of the main carriage 19007 from a remote location.

[0235] 94-96 illustrate an inserter assembly 20000 according to another embodiment of the present disclosure. The inserter assembly 20000 includes a needle guide 20001 that serves as an interface between the inserter assembly and a needle 20003. The needle guide 20001 is configured to guide the needle into a patient's anatomy. The needle guide 20001 can also serve as a guide for manual insertion of the needle 20003. The needle guide 20001 has a cylindrical slot 20010 that translates rotational movement of the cam driver 20004 about axis A into rotational movement of the needle guide about axis B, as best shown in FIGS. 94 and 96.

[0236] Two rotary actuators 20002 drive a mechanism to move the needle 20003. The actuators 20002 may be electromagnetic, piezoelectric, pneumatic, or hydraulic motors. A cam driver 20004 coupled to one of the rotary actuators contains a mechanism that is contained in, but freely rotates within, the cylindrical slot 20010. The mechanism, in one embodiment, is spherical.

[0237] A pivot pin 20005 coupled to one of the rotational actuators controls the rotation of the needle guide mechanism 20001 about axis A. The pivot pin 20005 is coupled to the needle guide mechanism to ensure that rotation of the needle guide about axis B is generally unconstrained.

[0238] In one embodiment, for simplicity of design and additional mechanical advantage, the rotational motion is transmitted from the rotary actuator 20002 to the cam driver 20004 and pivot pin 20005 via intermediate gears 20007, 20008, 20009, as best shown in FIGURE 96. In other embodiments, the rotary actuator may be directly coupled to the cam driver and pivot pin, or may be coupled via a worm gear to allow the inserter assembly 20000 to fit inside different envelopes or to increase the force and / or speed of needle insertion.

[0239] The inserter assembly 20000 is easily miniaturized, particularly due to the similarity in scale of the motor and mechanical parts. The fixed motor of the inserter assembly 20000 has reduced inertial mass. The mechanism of the inserter assembly 20000 rotates the needle about two independent, perpendicular axes A and B, allowing control of angles Φ and ρ as best shown in Figures 94 and 96, respectively. This allows rotation about axis A, which would otherwise be driven directly by a rotary actuator, and rotation about axis B, to be driven indirectly via a cam follower.

[0240] 97-100, an inserter assembly 21000 according to another embodiment of the present disclosure is shown. The inserter assembly 21000 includes three linkages 21001, 21002, and 21003 that jointly control the location and orientation of a linear mechanism 21004. In one embodiment, the linkages 21001, 21002, and 21003 each have a single degree of freedom of movement in the y-direction, as shown in FIG. 99. Each of these linkages is driven by an independent linear actuator. Control of the angle φ is achieved substantially by the opposing movement of the linkages 21002 and 21003. Control of the angle ρ is achieved substantially by the opposing movement of the linkages 21001 and 21002 or 21003.

[0241] Each linkage interfaces with the linear mechanism through a joint that can pivot with two degrees of freedom, e.g., a ball joint. Linkage 21002 includes an additional single degree of freedom joint 21010 to prevent binding during rotation.

[0242] The linear mechanism 21004 includes an actuator for driving the carriage 21005 substantially in the x-direction. An actuator 21009 attached to the carriage 21004 delivers torque to the needle driver 21006 via the needle attachment interface 21008 to power the insertion and retraction of the needle 21012 into the patient's anatomy.

[0243] The needle driver 21006 can deliver the needle into or out of the patient's anatomy. In one embodiment, this movement can be controlled by a lead screw. The needle driver can be a disposable, sterile assembly that protects the healthcare provider and patient from pathogen contamination. The housing 21007 can include an actuator that powers the linkage. The housing can secure the inserter assembly 21007 to prevent unwanted movement during the procedure.

[0244] The inserter assembly 21000 provides full control of needle location and orientation with four degrees of freedom, allowing for complex plunge trajectories. When a disposable / sterile needle canister is not installed, the inserter assembly 21000 collapses to a small volume relative to the length, width, and depth of the workspace it can access, as best shown in FIG. 100. The inserter assembly 21000 can accommodate needles of various lengths, gauges, and configurations and provides damage resistance in all five axes of motion through the use of a non-backdrivable lead screw.

[0245] 118A and 118B show an inserter assembly 38000 according to another embodiment of the present disclosure. The inserter assembly 38000 includes a foldable frame 38002 that can hold a needle 38006. The angle of the foldable frame can be adjusted to adjust the angle of entry of the needle 38006. A swivel-mounted needle holder 38004 allows for further adjustment of the needle entry angle. The needle can be manually advanced or retracted after the exact insertion location and needle angle trajectory have been determined. The inserter assembly 38008 includes an adhesive surface 38008 to firmly secure the inserter assembly at the target surgical site, as best shown in FIG. 118B.

[0246] FIG. 121 shows an inserter assembly 41000 according to another embodiment of the present disclosure. The inserter assembly 41000 includes a cartridge 41002 containing a needle. The cartridge 41002 may be placed within a frame 41005 that is attached to the surgical site via a support 41006. The frame 41006 allows movement in three axes to position the needle at the optimal insertion point. The frame 41006 may be made of a permeable material 41004 to provide the operator with a clear indication of the insertion. The cartridge 41002 may be a reusable cartridge that can be conveniently replaced for each insertion.

[0247] 126 , an inserter assembly 46000 according to another embodiment of the present disclosure is shown. The inserter assembly 46000 can be secured to a strap 46004. A needle 46008 can be loaded into the loading chamber and actuated by a button 46002 to perform needle insertion. A manual override button 46006 is also provided to allow the operator to stop the insertion procedure if necessary. The loading chamber includes a window to allow the operator to view and ensure needle penetration at the insertion point 46010. The insertion point can be highlighted by a laser crosshair or other indicator to assist the operator.

[0248] Usage Overview A method for performing semi-autonomous needle insertion using device 10 is now described. The puncture site skin area for insertion is prepared by manually swabbing or sterilizing, or by applying a protective visor. The visor may also contain an ultrasound-compatible hydrogel to facilitate ultrasound scanning, eliminating the need for manual application of ultrasound gel. After preparing the skin area, the user can dock housing 100 to base 200 and place the assembly at the puncture site area. Straps or other fixation elements may be used to secure the device to the patient. However, in this embodiment, the tightened straps will have enough slack to allow the operator to move the base across the puncture site area to scan the patient's vasculature. 3D scanning using any of the techniques described herein may be used to generate a 3D map of the patient's vasculature. The 3D map may include real-time and / or static images, such that areas within the direct field of view of the 3D sensor can be shown in real time, and other areas not within the path of the 3D sensor can be scanned and saved to generate a 3D map of the patient's vasculature. The GUI of device 10 can project a 3D map of the puncture site onto a display screen on housing 100, or transmit this data to another monitor located remotely from device 10. Device 10 can include puncture site fiducial markers that can assist the operator in accurately positioning the device over the puncture site by aligning the puncture site fiducial markers along the 3D mapped vessel. After the device is successfully positioned at the puncture site, the operator can activate the insertion mechanism to insert the needle into the puncture site along a predetermined trajectory. After needle insertion is achieved, housing 100 can be removed from the base without disturbing the needle, leaving the needle assembly secured in the patient by the base.

[0249] A method for performing autonomous needle insertion using device 20 is now described. The puncture site skin area for insertion is prepared by manually swabbing or sterilizing the area or by attaching device 20 to the puncture site skin surface. Device 20 may include sterilization features, such as ultraviolet light or other disinfectants. Alternatively, a protective visor may be first placed on the puncture site surface, and device 20 may be attached to the visor. As previously mentioned, the visor may include various features, such as ultrasound-compatible hydrogel to facilitate ultrasound scanning, eliminating the need for manual application of ultrasound gel. After preparing the skin area, the user can dock housing 400 to base 500 and place this assembly at the puncture site area. By docking housing 400 to base 500, plate 550 may be removed from device 20, as inserter assembly 600 is now secured by housing 400. Strap 508 may be used to secure the device to the patient's skin. The operator can then initiate a 3D scan via the GUI, and the device will scan and 3D map the patient's vasculature. The 3D map can include real-time and / or static images, where, for example, areas directly in the path of the 3D sensor can be shown in real time, and other areas not in the path of the 3D sensor can be scanned and saved to generate a 3D map of the patient's vasculature. The GUI of device 20 can project a 3D map of the puncture site onto a display screen located on housing 400 and transmit this data to another monitor located remotely from device 20. Device 20 can include puncture site fiducial markers that can help the operator accurately position the device over the puncture site by aligning the puncture site fiducial markers along the 3D mapped vasculature. After the device successfully identifies the insertion site of the puncture site and determines a trajectory to achieve insertion, the operator can activate the insertion mechanism to insert the needle along the predetermined path to the puncture site. The operator may be located remotely from the device and can activate the insertion mechanism remotely.Alternatively, the device may be fully autonomous, whereby the device automatically initiates insertion after identifying the puncture site with little or no operator input. When the needle is inserted, the housing 400 may be removed from the base without disturbing the needle, leaving the needle assembly secured to the patient by the base.

[0250] Alternatively, once the appropriate puncture site, insertion trajectory, and target vein have been identified, the operator can then use this information to select and attach a needle to the device for subsequent insertion of the needle at the puncture site.

[0251] Level of automation As mentioned above, the device may be semi-autonomous or fully autonomous. Individual components, such as the navigation system, display, and user interface, and the inserter assembly may each have different levels of automation in a semi-autonomous device. For example, a device may have a manual navigation system that requires an operator to position and scan the puncture site skin area, but may include a fully autonomous insertion assembly that performs needle insertion and retraction without manual input. It is envisioned that the device may have modular components that are compatible with each other. For example, an operator may simply attach navigation and sterilization components to the housing to perform a specific function. This would allow the housing to be customizable for each of a variety of applications, thereby enabling it to be used across these applications.

[0252] Additional Design 18 and 19 illustrate various embodiments of patches that can operate as both a pre-injection patch and a base, as described above. As shown in FIG. 18, patch 950 can be applied to the area of ​​the patient where a puncture site is desired. Patch 960 can encase the patient's appendage, such as the arm, as best shown in FIG. 19. As described above, a housing can then interface with the patch. For example, such patches can be particularly useful if the housing includes ultrasound navigation capabilities, whereby the patch would include a hydrogel or other such ultrasound-conductive layer. These patch embodiments are also useful in that the housing can be freely moved around the surface of the patch, which is sterile, without concern for moving the housing outside of a sterile field.

[0253] Further exemplary embodiments of gel-based pads that may be used as part of the devices of the present disclosure are described below.

[0254] 81A-C illustrate one embodiment of pad 15000. Pad 15000 is a flexible, 3D, device-integrated, dry gel coupling agent that enhances usability by facilitating consistent transmission of ultrasound and simplifying the transition between the organic and variable human form and the rigid exemplary device 5000 shown here.

[0255] Currently, a strong, viscous gel is required as a coupling agent to create a transition between the ultrasound ("US") probe and the patient's body to successfully transport the ultrasound waves back and forth. This gel is messy, cumbersome, and unhygienic. With a flexibly formed "dry gel," sometimes called a hydrogel, these pain points can be eliminated. Additionally, Pad 15000 provides an improved ergonomic transition from the probe to the body. A seamless and easy-to-achieve device transition means better data capture and image quality.

[0256] One major challenge addressed by the present solution is the mismatch between the organic and variable nature of the human body and the rigid and restricted geometry of the US probe. The transition, or connection, between these two completely different surfaces is very difficult to overcome with wet gel or even with the current dry gel products currently available. The procedure also requires considerable operator skill to achieve high-quality images.

[0257] The dimensions, thickness, density, consistency, flexibility, material, and surface treatment, as shown in Figures 81B and 81C, allow the pad 15000 to easily couple the device 5000 to any part of the body, large or small. The cavity 15002 is formed to easily receive the CMUT array 5004.

[0258] Pad 15000 facilitates easy interface with the patient's body. The CMUT array 5004 is designed and engineered with high quality data capture in mind. Any layers, materials, shapes, or manufacturing processes added to the probe surface to improve interface with the human body can be given lower priority since pad 15000 addresses these requirements.

[0259] Additionally, pad 15000 may be customized or provided in standard sizes, rather than one size fits all approach to US use. For example, a range of pads 150000 may be used to improve connectivity in specific cases, from newborns to the elderly, from frail to obese.

[0260] Pad 15000 can be made of a very flexible yet solid, clear material that fits snugly and integrates seamlessly with device 5000, coupling anywhere on the body as easily as placing the device and contacting the skin. Small movements and pressure changes are easily absorbed by the dry gel, while clear and accurate images are captured on display 5012. Curvatures and irregularities in the patient's body surface are easily overcome by the flexibility of pad 15000.

[0261] 82A-D show pad 16000 according to another embodiment of the present disclosure. Pad 16000 is generally similar to pad 15000, but includes a distal surface that forms optional surface features. As shown in FIGS. 82B-D, the distal surface of pad 16000 conforms to a corresponding surface to form a secure attachment.

[0262] 83A-I, various embodiments of a pad 15000 according to the present disclosure are shown. The pad 15000 shown in these figures comprises variously designed and shaped 3D dry gel foams that enable three-dimensional CMUT(US) configurations and surfaces for improved data capture and ease of use.

[0263] Freed from the ergonomic constraints of interfacing directly with a patient's body, the 5000 C MUT array 5004 of the exemplary device can be fully optimized for data capture for venous access or other procedures. Pads 15000 can be provided in a variety of shapes and configurations to capture all essential details for venous access. For example, a flat, rectangular shaped pad 15000 is shown in FIG. 83A.

[0264] An entirely flat array may not be an ideal configuration for venous access. Veins are superficial, small, and often mobile. The curvatures, angles, steps, convexities, and concavities of the CMUT array can create triangulation and redundancy that will make the image dataset more robust and our image quality more reliable. FIG. 83B shows a pad 15000 with a tapered distal end along with a larger display 5012. FIG. 83C shows a pad 15000 with a distal end that flares out from the display 5012 leading to a pad with a larger contact surface. Thus, a smaller screen 5012 can be used in the embodiment shown in FIG. 83C, allowing for a smaller, more compact device 5000.

[0265] FIG. 83D shows a pad 15000 that can be coupled to a CMUT array 5004 with another opening. The CMUT array 5004 has a single opening 15005 that allows a needle to pass through. The opening 15005 is filled by the pad 15000, as shown in FIG. 83D. FIG. 83E shows a similar CMUT array 5004 with two arrays tilted on either side of the opening. In yet other embodiments, a variety of different configurations of CMUT arrays can be accommodated by the pad 15000. For example, FIG. 83F shows a stepped CMUT array 5004, and FIG. 83G shows a concave CMUT array 5004. In yet other embodiments, the pad 15000 can be concave or convex, as shown in FIG. 83H, or flexible, as shown in FIG. 83I.

[0266] FIG. 84 shows a pad 17000 coupled to a device 5000 according to another embodiment of the present disclosure. The pad 17000 is made of a clear gel to provide the operator with a clear view of the insertion site 17007 located below the pad. This allows the operator to image the insertion site 17007 with the device 5000 and view it via the display 5012 while simultaneously observing the insertion site 17007 with the naked eye through the clear gel of the pad 17000. Because the device itself would normally obstruct the operator's view of the insertion site, the operator must slide the device across the insertion area. The pad 17000 allows for an analog view of the site from above while also providing a subsurface view (US) of the insertion site on the display 5012. The pad 17000 allows the device 5000 to be recessed from the insertion site by an angled CMUT array 5004′, as shown in FIG. 84.

[0267] 85A-C show insertion procedures using different embodiments of gel pads. The needle tip 5010 cannot be seen on the display 5012 prior to insertion with the thin, low-profile pad 15000 shown in FIG. 85A. The thin, low-profile pad contacts the needle during or immediately prior to insertion, and therefore cannot be seen on the display 5012 prior to insertion.

[0268] The thicker pad 15000 shown in FIG. 85B allows the needle tip 5010 to enter the pad 15000′ prior to insertion into the patient. Thus, the needle tip 5010 can be tracked prior to insertion. As shown in FIG. 85B, the thickness of the pad 15000′ must take into account the needle size, needle incidence angle, and the distance of the insertion zone from the edge of the pad 15000′.

[0269] FIG. 85C illustrates needle insertion using the aforementioned pad 17000. As shown here, the angled shape of pad 17000 allows the needle to enter the pad before reaching the insertion point. Thus, the needle tip 5010 can be seen on the display 5012 before the needle actually pierces the patient's skin. Furthermore, the clear nature of the gel used in pad 17000 allows the operator to see the insertion site through the clear gel and directly track the needle tip. As the needle is placed within the gel, the CMUT array collects data regarding its location and incorporates it into the screen image. Any adjustments that may be required, such as needle trajectory, pad (and imaging device) location, etc., can be made before piercing the skin with the needle remaining within the pad and visible to the naked eye or on the display. Thus, pad 17000 conveniently allows imaging and treatment to occur simultaneously.

[0270] 111A and 111B show a pad 31000 according to another embodiment of the present disclosure. The pad 31000 includes a recess 31002 configured to secure and align a needle 31004 to facilitate accurate insertion. The pad 31000 can be coupled to a visualization device 31003 as shown in FIG. 111A.

[0271] 112A and 112B, a pad 32000 according to another embodiment of the present disclosure is shown. The pad 32000 includes a flexible port 32004 for receiving and aligning a needle 32004 to facilitate accurate insertion. A visualization device 32003 may be coupled to the pad 32000 as shown in FIG. 112A. In other embodiments, various types of recesses, ports, and other receptacles may be included or integrated into the pad for receiving, holding, and aligning a needle.

[0272] FIG. 113 illustrates a pad 33000 according to another embodiment of the present disclosure. The pad 33000 includes a self-sealing slit 33003 that can receive a visualization device 33002. The pad 33000 is configured to completely encase and protect the visualization device, as shown in FIG. 113. The pad 33000 may be made of a clear gel to allow an operator to view and use the visualization device 33002 placed within the pad. In some embodiments, the pad 33000 may include a split body attached by a hinge 33004 to allow access to the visualization device seated therein.

[0273] 114A, a pad 34000 according to another embodiment of the present disclosure is shown. The pad 34000 includes a gel layer 34004 and an adhesive layer 34002 in contact with the skin. The adhesive layer has an internal lattice structure that distributes the downward pressure of the needle 34006 as it advances through the skin and vein 34008. This prevents the skin from slipping from the pressure of the advancing needle (FIG. 114B) and the vein from slipping from the pressure of the advancing needle (FIG. 114C).

[0274] 115A-C show a pad 35000 according to another embodiment of the present disclosure. The pad 35000 includes a pair of ridges 35002 that may be located on either side of the vein 35004 to stabilize the vein and prevent it from rotating under the pressure of the approaching needle.

[0275] The pads can be configured to perform a wide variety of functions: for example, they can be customized to prevent infection, maintain skin health, secure device components, reduce pain, optimize venous or other anatomical features, etc.

[0276] In one embodiment, the pad may include a low-friction hydrogel device cover that will allow the device to be guided smoothly and steadily across the skin surface with little effort from the operator.

[0277] In another embodiment, the pad can be configured as a large, stable pad that is highly conformable to easily transition from a flat sensor surface to the unique contours of the patient's body. This pad can be independently secured directly to the desired surgical area, such as the patient's chest or abdomen, to ensure that the distal surface of the pad contacts the body. A device having a large imager module can be coupled to the adjacent surface of the pad. The transducers of the large imager module are positioned to capture and display volume data of the surgical site. For example, the transducers of the large imager module can span across the imager module to capture volume data of the chest cavity and heart through an opening between the ribs with a single reading—i.e., they do not need to slide or move across the target site to generate image volume data. Alternatively, strategically placed transducers at specific locations across the imager module can generate volume data with a single reading to capture image volume data.

[0278] In another embodiment, pads can be customized to fit specific body parts for specific examinations and / or procedures to ensure convenient imaging of areas with difficult accessibility. The need for invasive scans is also reduced by these customized pads. Furthermore, body part-specific pads require less operator training and expertise to use them. Body part-specific pads can be paired with devices and imager modules to create kits for specific examinations and / or procedures. Securement devices for securing the body part-specific pads can be customized for these pads.

[0279] The pads can be designed to be patient-specific pads according to another embodiment of the present disclosure. Custom pads for each patient can be created in advance of the examination and / or treatment based on the patient's unique individual characteristics.

[0280] In one embodiment, the pad may include various infection prevention properties. The pad according to this embodiment may include an antimicrobial layer to prevent infection of the target site. The pad may be made of a clear gel to provide a clear view of the target site and to allow the needle to pass directly through the pad.

[0281] In one embodiment, a kit can include at least one pad and at least one device. For example, such a kit can include multiple pads and one device, whereby the pads are sized and shaped for use with a particular device. Furthermore, each pad can be specific to a particular treatment and / or anatomical location, and at the same time, each pad can have a shape different from at least one other pad so that all pads can be used with a particular device. In another example, such a kit can include multiple pads and multiple devices, whereby each pad is sized and shaped for use with at least one device. A user of this exemplary kit can select the desired pad and device combination for use in a particular treatment and / or anatomical location.

[0282] In another embodiment, a method of using a device may include selecting a particular pad and a particular device and using the combined pad and device to view an anatomical location on a patient. Such a method may further include using the combined pad and device with one or more medical devices or instruments to view both the anatomical location on the patient and the medical devices and / or instruments near the anatomical location. Such a method may also include using the combined pad and device, or different combinations of pads and devices, to view multiple anatomical locations. In one example, visualization of a catheter being inserted into a patient across the femur may be viewed using a first combination of pads and devices, and a different combination of pads and devices may be used after the catheter has entered the abdominal or thoracic vasculature.

[0283] 120A-D show a venous dilation device 40000 according to another embodiment of the present disclosure. The venous dilation device includes a needle 40008 that can be transferred by a grip 40004. A skirt 40006 surrounds the needle and forms a seal with the patient's skin, as shown in FIG. 120B. After the needle is inserted into the collapsed vein 40010 (FIG. 120C), the balloon member 40002 can be squeezed to force air through the needle and into the collapsed vein 40010, expanding the vein, as shown in FIG. 120D.

[0284] 124 illustrates a sterile bandage 44000 according to another embodiment of the present disclosure. The sterile bandage 44000 provides a sterile field through which a needle can be inserted. When a sterile bandage is used, no additional sterilization is required. Various features can be added to the sterile bandage to assist with needle insertion. For example, a targeting mark 44302 can serve as an alignment and location guide for needle insertion.

[0285] 125A and 125B show a needle 45000 according to another embodiment of the present disclosure. The needle 45000 can be rotated to change the distal profile of the needle. As shown in FIG. 125B, the distal end of the needle 45000 can change from a piercing point 45002 to allow smooth entry into the vein to a flat surface 45004 to ensure the needle does not pass through the vein.

[0286] Closed Loop In another embodiment, an automated or semi-automated mechanized intravenous needle placement device or system can perform several output functions to optimize anatomical targets or other conditions related to intravenous needle placement, such as, for example, reducing pain or aiding in mechanized placement of an imaging device or inserted module. Measurement of various device outputs can be achieved with ultrasound imaging transducers, e.g., CMUTs, or camera sensors, NIR or other imaging systems, and monitoring changes in 2D or 3D data maps of the target anatomy, or temperature sensors. Other monitoring methods can include readings of the patient's local or core temperature, hydration level, heart rate, blood pressure, sweat level, general or sudden movements, shaking and trembling, noise and pain level (some or all of which can also be monitored by an operator, e.g., a trainee). Environmental conditions, such as room temperature, patient and / or device orientation, location, ambient noise, lighting, time of day, certain weather conditions, etc., can also be monitored. Some or all of these readings may be fed back to an operator or input into the electrical or electronic control system of the device or system so that adjustments to the device output can be made and / or directed to occur when more optimal input readings or conditions are met. Feedback, or closed-loop, systems are designed to automatically achieve and maintain desired output states by comparing actual conditions with desired output states in real time.

[0287] Continuing with this embodiment, various examples include: mechanical or electrical stimulation implemented to induce functional responses in a patient's organs, vessels, tissues, or peripheral or central nervous system, or to guide mechanical imaging or needle placement devices within the system. Examples may include stimulation to optimize characteristics (e.g., venous dilation or stability) of a target vasculature or anatomical structure via automatic tightening of an integrated compression cuff; applying heat to a target area injection site via an integrated heating element, e.g., to enhance venous dilation; applying mechanical vibration or tapping to stimulate a target vessel; providing a mechanical compressive force or similar massage effect at or around a target injection site to measure vascular properties under compression or stimulation (veins are typically more compressible than arteries, or weak or thin veins may rotate or move more than healthy veins). These inputs, while typically performed by a human operator in the course of routine practice, are time-consuming, highly manual, and require patience and skill to perform effectively.

[0288] Another example is the automated release of venous dilators or painkillers into the body around the target insertion site, or the application of local cooling to the insertion site, or similar anesthetic techniques. This would typically be performed manually, adding unnecessary additional manual preparation and time prior to the procedure. The effectiveness of these outputs can be monitored in real time by outputting and then monitoring a physical stimulus to the patient, i.e., causing and then measuring a change in nervous system response (i.e., an analgesic or distraction effect), or simply asking the patient (in which case the patient's determination of pain sensation can be input into the device or system). Input feedback to the automated system can be to increase or decrease the analgesic or cooling or similar output, or, as described further below, to implement a distraction method at the time of injection, such as an evoked response. Alternatively, the procedure can be delayed until a more optimal state is achieved.

[0289] In a further example of fluid control, pushing fluids or therapies into or withdrawing blood from the body may typically be performed manually by an operator or an external infusion pump or system. Contemplated devices can mechanically assist such fluid control, semi-automatically or fully automated. The effectiveness of these mechanical outputs can be monitored in real time, for example, by sensory monitoring of vessel dilation or collapse, fluid flow rate, occlusion, needle or vascular fluid breaks, and 2D, 3D, or 4D anatomical data mapping using ultrasound transducers. Input feedback sent back to the automated system can simultaneously increase, decrease, or stop the fluid flow rate.

[0290] In another example, to provoke a response from the patient—to distract from the pain of the injection or other physical input—the device or system, and / or its operator, may elicit a physical response from the patient, such as causing a rapid expulsion of air from the lungs (inducing or asking the patient to cough), or screaming on demand, or making a rapid physical movement or sound, e.g., clapping hands or hitting an object, or engaging with a momentary stimulation device or prop, such as a jack-in-the-box. Alternatively, the system may communicate with and work in conjunction with an external stimulus, such as an audio system or other device held by, attached to, or near the patient, that captures the patient's attention, perhaps unexpected or slightly shocking, when activated, e.g., to momentarily increase blood pressure or heart rate. For example, the elicited physical action can be monitored via integrated or external sensors, allowing the input information to be fed back to the control system, so that the moment of greatest pain (i.e., at the time of needle injection) can be staged with greatest physiological distraction.

[0291] Furthermore, although the invention disclosed herein has been described with reference to particular features, it is to be understood that these features are merely illustrative of the principles and applications of the present invention. Accordingly, it is to be understood that numerous modifications may be made to the exemplary embodiments, including changes in the size of the various features described herein, and that other configurations may be devised without departing from the spirit and scope of the present invention. In this regard, the present invention encompasses numerous additional features in addition to those specific features described in the following sections. Moreover, the present invention is defined in the following numbered section examples, which describe features in accordance with various embodiments of the invention, and the foregoing disclosure should be interpreted as illustrative and not limiting.

Claims

1. a first visualization device comprising a first array of transducers disposed on a distal surface, the first array having a first footprint, the first visualization device configured to generate a first volumetric image dataset of an anatomical region, the first volumetric image dataset being defined by the first footprint and a first depth; a second visualization device comprising a second array of transducers disposed on a distal surface, the second array having a second footprint, and configured to generate a second volumetric image dataset of the anatomical region, the second volumetric image dataset being defined by the second footprint and a second depth; the second visualization device is separate from the first visualization device; with the first visualization device positioned at a first location relative to the anatomical site and the second visualization device positioned at a second location relative to the anatomical site, the second location being different from the first location; a third volumetric image data set defined by the first volumetric image data set and the second volumetric image data set, the third volumetric image data set including anatomical features of the anatomical region within a volume defined by the third volumetric image data set; A medical imaging system, wherein the third volumetric image dataset is a three-dimensional image dataset provided for display on a display screen and configured to be manipulated by a user via one or more inputs received via the display screen.

2. The medical imaging system of claim 1 , wherein at least one of the first and second footprints is substantially circular.

3. The medical imaging system of claim 1 , wherein the first footprint is larger than the second footprint.

4. The medical imaging system of claim 1 , wherein the first and second volumetric image data sets are generated simultaneously.

5. The medical imaging system of claim 1 , wherein the first volumetric image data set is generated prior to generation of the second volumetric image data set.

6. 6. The medical imaging system of claim 5, configured to determine a position of a second visualization device relative to the anatomical region to generate a second volumetric image dataset based on the first volumetric image dataset.

7. The medical imaging system of claim 5 , configured to determine the placement of the second visualization device based on stored information related to a medical procedure.

8. 2. The medical imaging system of claim 1, wherein the first and second arrays of transducers are capacitive micromachined ultrasonic transducers (CMUTs), piezoelectric micromachined ultrasonic transducers (PMUTs), or a combination thereof, disposed on a substrate, the substrate being disposed within the first and second visualization devices.

9. The medical imaging system of claim 1 , further comprising a display screen for displaying the third volumetric image data set.

10. 2. The medical imaging system of claim 1, wherein the first volumetric image data set is generated by the first visualization device located at a first location relative to the anatomical region, and the second volumetric image data set is generated by the second visualization device located at a second location relative to the anatomical region.

11. 2. The medical imaging system of claim 1, wherein anatomical features in the first volumetric image data set that are obscured by any of bone, fluid, and other obstructions are captured by the second volumetric image data set.

12. The medical imaging system of claim 9 , wherein the third volumetric image data displayed on the display screen includes two of the volumetric image data sets generated by the visualization device.

13. The medical imaging system of claim 9 , wherein the display screen comprises a plurality of screens, each screen being perpendicular to at least one other screen.

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